CN102295788A - Film coating formula containing calcium carbonate, usage method thereof and purpose thereof - Google Patents

Abstract

The invention relates to a film coating formula containing calcium carbonate, a usage method thereof and a purpose thereof. The film coating formula comprises a polyol, a cellulose polymer, calcium carbonate or calcium phosphate, a plasticizer, a lubricant, and a coloring agent, wherein calcium carbonate which contains no heavy metals and is cheap and safe is used to replace an expensive component titanium dioxide. The film coating formula preferably uses nano-scale ultrafine calcium carbonate which has the advantages of high purity, good whiteness, and fine granularity, and can be used in cosmetics, health products, and medicines. The formula which is safe, effective, stable, and economic and adopts edible or medicinal components has a wide application range, so the production cost is reduced. The formula which has the advantages of simple preparation technology and simple quality control is suitable for large scale production and business application of enterprises, and has a good application prospect and substantial social benefits and economic benefits.

Description

A kind of film coating prescription calciferous and using method and purposes

Technical field

The present invention relates to technical fields such as medicine, food, healthcare products, specifically relate to a kind of dressing and using method and purposes of product, more particularly relate to a kind of film coating component and using method and purposes that contains the lime carbonate composition.

Background technology

(1) film-coated research overview

1, general introduction

Film coating is a kind of novel packaging technique, refers to wrap outside label more stable thin layer polymer clothing film.Film coating procedure is a kind of novel technology of the exploitation forties in 20th century, and it at first results from pharmaceutical industry, is used to protect the medicine slice, thin piece; Compare with sugar-coat, have characteristics such as with short production cycle, that materials are few, wetting resistance is strong.

This technology is easy to exploitation and produces, and range of application is very extensive, is mainly used in the dressing of medicine, food, healthcare products.

In the dressing process,, can be divided into water-soluble art for coating and organic solvent art for coating according to the difference of solvent.

Film coating is with polymkeric substance film forming technology outside solid dosage.As evenly spray the macromolecule polymer material of one deck stable in properties by spray method on plain sheet surface, form the plastic films layer of number micron thickness, it is produced a desired effect.

The formation of outer this thin film of tablet is to stick the polymer coating material by single tablet after by spray area, accept the next section coating material after being dried again, through so multiplely stick, drying, be capped fully up to whole formulation surface, dressing is finished.Film-coat is a two-layer continuous film, and thickness between 8～100 μ m, has certain elasticity and snappiness mostly, closely attaches to the medicine wicking surface, generally is difficult to peel off, and this clothing film is called " non-stripping film ", is commonly called as " dura mater ".But a class film is also arranged because of the requirement of medicine core characteristic, adopt special coated formula, the clothing film is pliable and tough especially after the film forming, can from the sheet wicking surface in flakes in addition integral body strip down, this clothing film is called " peelable film ", is commonly called as " mantle ".

2, principle

When Swertia Tablet turns round in the dressing machine, with the superfine little droplet jet of dressing solution or suspension appearance to label, when these drops arrive label, by contact, sprawl, being bonded with each other between drop, form one deck clothing film on the surface of label, between solvent and the label two kinds of effects can take place in this process, promptly solvent is to the osmosis of label and the Evaporation of solvent.

Fixed when the steam output of solvent weighing apparatus, and when equating with the solvent straying quatity, the process of dressing reaches balance.So in the development process of present dressing equipment, improved main purpose is to improve vaporization efficiency, to accelerate hydrojet speed, shortens the operating time.

The moistureproof moisture resistance principle of film coating agent: 1. water molecules " is kept outside of the door ", adopt some hydrophobic materials or indissoluble material, contain a large amount of hydrophobic groupings in its molecule, in the clothing film, can form the continuous structure of even compact, as one firm floodwall, with water " film of refusing is outer ".2. water molecules " is eaten up ", some easy hydrates are distributed in the clothing film equably, in a single day water molecules invades the clothing film, immediately it " is caught, eats up ", it is bound by among the non-blushing thinner molecule, and is unlikely to enter the medicine core.

3, film-coated purpose

Conclusion is got up, mainly contain following some:

1. some material has bitter taste and smell is not good in the label, and dressing can cover unpleasant odor, be convenient to patient takes, and alleviates gastrointestinal reaction;

2. some material is seen photo-labile or easily oxidation in air in the label, and dressing can protection against the tide, lucifuge, secluding air be with the increase stability of drug etc.;

3. label is not attractive in appearance, and dressing can improve outward appearance and be convenient to identification;

4. activeconstituents is coloured, and easily pollutes patient's clothing and hand;

5. change the drug release curve.Control drug release, for example: enteric, sustained release coating;

6. dressing can reduce the slice, thin piece fragmentation, improves productive rate;

7. unified compressing tablet after the pharmaceutical cpd that has compatibility to change can being placed the sheet heart and clothing layer respectively or carries out dressing is respectively promptly isolated two kinds of immiscible materials, can place it in the clothing layer or be made into coated pellets after compressing tablet again, also to avoid other and change etc.

4, film-coated type and characteristics

The division of film coating agent kind can divide according to the position of release in the human body and the feature of release, and concrete gastric soluable, enteric solubility, mouthful molten type, slow-releasing, controlled capability and other of being divided into can be divided into water-soluble type and ethanol-soluble type according to characteristic.

(1) type

According to type solvent characteristics, be divided into:

1. gastric soluable

Full water coventional type: full water shading, painted, taste masking;

Full water damp-proof: full glassware for drinking water has moistureproof moisture-resistant function;

Standard type: 70% following ethanol shading, painted, taste masking;

Damp-proof: 85% following ethanol has moistureproof moisture-resistant function;

Special damp-proof: 85% above ethanol has the moistureproof moisture-resistant function of extra-heavy;

Transparent type: ethanol or water insulation blocking keep the label primary colors;

Sealing coat: ethanol or water insulation blocking are applicable to dark label, shading, protection against the tide.

2. enteric solubility

Common enteric solubility, special enteric solubility, transparent type (ethanol or water insulation blocking keep the label primary colors), sealing coat (being applicable to dark label, shading, protection against the tide);

3. special type: generally be meant a mouthful molten type, slow release type, control release type etc.

(2) characteristics

1. protection against the tide, moisture-resistant, shading,, sugar-coat then easily goes mouldy, softens, ftractures;

2. the sheet type is attractive in appearance, bright in luster, sign is pure and fresh, vivid; Then irregular colour is even, sign is unclear for sugar-coat;

3. then thick, the weightening finish obvious (being generally sheet weighs more than 50%) of bisque of weightening finish few (be generally sheet and weigh 0.5～3%), sugar-coat;

4. the operating time is lacked (2～3 hours), sugar-coat length then consuming time (10～16 hours),

5. nontoxic, tasteless, odorless (scalable crowd), sugar-coat then contain sugar part (having limitation, as the diabetics);

6. easy disintegrating has improved dissolution rate, availability, validity period, and sugar-coat then has limitation;

7. wide in variety,, the enteric molten, to suck in addition, slowly-releasing, controlled release etc. except that stomach, it is molten that sugar-coat then generally can only wrap stomach.

In addition, some pharmaceutical factory autogamy coating liquid also has obvious drawback: be difficult to the homogeneous of ensuring the quality of products, denaturalization phenomenon takes place easily, cost is also higher relatively;

5, film-coated using method and production unit

(1) production unit

Film-coated technique has description (pa, 18th ed.Chapter 90 (1990) for A.L.Gennaro chief editor, Mack Publishing Co.Easton) in Remington ' s " pharmaceutical science ", be attached to the present invention at this and do reference.

Mainly contain three kinds of production units, be respectively: traditional coating pan, Highefficentcoatingmachine, fluidized-bed.

The sugar-coat art for coating all carries out in traditional coating pan, but drying efficiency is not ideal.Because drying air stream just contacts with the slice, thin piece of sheet bed upper surface, also there are defectives such as equipment claimed transformation, operation inconvenience simultaneously.Therefore, should not adopt this kind equipment to carry out film coating production.

Highefficentcoatingmachine divides two kinds of perforation coating pan and no eyelet coating pans again.Perforation high-efficiency coating pot is the stainless steel full-enclosed structure, on the pot wall venting hole is arranged, and warm air is discharged from pot wall upper air-vent after passing bed of material.Non air exit hole on the pot wall of no eyelet coating pan, hot air outlet is discharged from pot rear part exhaust hole after passing bed of material in bed of material.This dual mode has all increased drying efficiency.

Usually have mixing device in the coating pan, to improve the medicament mixed homogeneity.According to by the situation of bag thing, be used for carrying to spray the installation of spray system of coating liquid different.Drying air stream can be from top to bottom or is passed medicine sheet bed from the bottom up.This kind equipment is to carry out the major equipment that film coating is produced at present, is mainly used in the film coating of water miscible film coating and organic solution.

Fluidized-bed is usually used in the dressing of the water-soluble or organic solvent of small-particle, particle or micropill, but because its mechanicals efforts is stronger, and the medicine slice, thin piece is easy to wear, so and be of little use.

In the dressing process, influence that the equilibrated parameter can be divided into two classes between hydrojet and the drying: 1. relevant: hydrojet type, hydrojet speed, nozzle diameter, spray gun height, spraying pressure with hydrojet; 2. relevant with drying: inlet temperature, air output, time of drying, batch weight.Another important parameters is the rotating speed of coating pan, and it does not all have direct relation with hydrojet and drying, and relevant with the motion of material.Regulate rotating speed, can make the motion of material regular as far as possible.

(2) common used material

1. film forming material: must have physicochemical characteristics such as film-forming properties, solvability and stability.Wherein water miscible film forming material comprise Vltra tears (be called for short: HPMC), acrylic resin (Eudragit L30D), Sulisi (Aquacoat, Surelease) etc.; The film forming material of organic solvent comprises that Eudragit, L.S.RC, HPMC, shellac (Shellac), polyethylene titanic acid ester (are called for short: PVAP), cellulose acetate-phthalate (is called for short: CAP) etc.

2. softening agent

Water miscible softening agent comprises propylene glycol, glycerine, polyoxyethylene glycol;

Non-water-soluble softening agent comprises phthalic ester, castor-oil plant wet goods;

3. supplementary component: comprise lubricant, tinting material, opalizer etc., as talcum powder, Magnesium Stearate, pigment, CO ₂Deng;

4. solvent: commonly used have water, an ethanol etc.

(3) using method and precaution

The film coating process mainly is:

The preparation of dressing solution or suspension; The generation of droplet; Droplet moves to the substrate bed from spray gun; The bump of droplet on sheet wicking surface or particle surface, wetting, sprawl and coalescent; Dry gelling and stick film forming.

1. solution

The physical properties of dressing solution all can exert an influence to each stage in the film coating process, and the physical properties that quantizes dressing solution is vital, so just can predict and estimate its influence to film-coated outward appearance of final formation and various character.

When coating liquid transfers to spray gun, by in the coating pan raise the liquid pipe time may be heated, the temperature of heating depends on pipeline material, length, spray velocity, inlet drying air temperature, gas volume flow velocity.When entering spray gun, will be cooled off by the high speed atomizing air around the nozzle.When liquid left nozzle, coating liquid was surrounded by high-speed air, and stable liquid stream accelerates to more than the certain speed, can provide energy to overcome viscosity and surface tension and produced droplet.

2. atomizing

More satisfactory spraying is to produce equal-sized single droplet, has only heat transfer, mass transfer and the time of drying of all droplets of ejection identical, and what could guarantee it can uniform distribution in tablet surface.If method is proper, all droplets all can arrive tablet surface with same state, and the clothing film that the moving circle pot of revolution can increase newly is dry and can be too not moistening.When droplet was sprayed to the sheet bed that rolls, droplet size, spray trajectory and rate of drying were all measured by each operation respectively.

The sheet bed itself is final exsiccant place, when air flows through the tablet gap will with its generation effect of mass transmitting.Mist droplet particle size distributes and depends on viscosity and surface tension, atomization air pressure, spray velocity and the used spray gun of dressing solution prescription.The mist of spray gun ejection is rectangular-shaped and follow the atomizing gas flow velocity of droplet to slice, thin piece or many particle surfaces, and the latter plays an important role in control droplet speed.When leaving spray gun, droplet slows down rapidly, but still the operation certain distance, its speed is far longer than the dry air of following, and in the droplet speed difference of mist square difference, there is different surface tension in droplet.

Utilizing the atomizing coating liquid, is a progressive intermittent process at tablet outer surface forming film clothing.During substantially through spraying area, by coating liquid droplet bump of different nature, when substrate through a dressing district, the number of bump droplet depends on the speed of substrate through spraying area, the effect of droplet bump substrate surface is depended in the distribution of droplet in the relative position of substrate and spray gun, spray shape and the spray, film-coat character and film formed mode.If will form continuously, level and smooth, the maximum film-coat of density and hardness, each impinges upon the droplet of substrate surface should be moist, can sprawl, and sticks and interact with substrate, perhaps can finish coalescent formation continuous film clothing and do not contain bubble.

3. surface effects

Film coating is that the mode with spraying is sprayed onto the sheet wicking surface of rolling with dressing solution, feeds warm air so that solvent evaporation in the label that rolls, thereby forms the film that one deck connects at the sheet wicking surface.The formation of droplet, droplet moves to label, droplet is sprawled at the bump of sheet wicking surface, coalescence effect, and the drying of film all be the influence film-coated important factor, so, need to be grasped its main points, and control its condition.

(i) wetting is the process at solid-steam interface, is exactly the process of " doing " surface change " wetting ".In this process, gas or the molecule of steam must leave solid surface, its position is replaced by solvent molecule simultaneously.The big young pathbreaker of the relative affinity between these molecules determines whether this process is spontaneous process, fully understand the influence of this process wetting power and wettability, and wetting power is meant the ability of the wetting label of droplet." wettability " be meant label by droplet wetting ability.Understand wetting this characteristic and just can know, in order to control the process that is taken place on droplet and the label interface, not only need to adjust the character of droplet in actual applications, also will adjust the character of label.

(ii) penetrate in the initial period of film coating process, droplet and the not sheet wicking surface collision of dressing, and the penetration of droplet takes place simultaneously and sprawl effect.The degree of penetration depends on the component of label and the interactional size between the capillary pipe structure, and the composition of coating liquid and physical properties.At label a large amount of pore textures are arranged, by its coating liquid penetration will take place, the volume that finally infiltrates the liquid of label just equals volume of voids, and the speed of infiltrating depends on the interaction of viscosity, surface tension and the solid surface of coating liquid.

(iii) spread in the dressing process, droplet bumps against with sizable speed and label.When droplet is forced in solid surface and flows with very high speed, will have bigger dynamic contact angle.The contact angle of droplet and sprawl function and the dressing solution viscosity that behavior mainly is an atomizing gas, just droplet depends on the physical properties and the kinetic energy of basic properties and droplet in the degree of sprawling of substrate surface.When the viscosity of droplet hangs down, the kinetic energy of droplet or momentum normally with it at surface spreading.The degree of sprawling of high viscosity droplet significantly reduces because of kinetic energy is low, makes it form very little sprawling at the sheet wicking surface, so, sprawl interaction and the time of drying depended between droplet surface tension and the substrate.Owing to the too poor film-coat defective that causes of the spreadability of coating liquid is called as " tangerine peel ", promptly outward appearance is the same with regard to the sub-skin of elephant apple.

(iii) stick coating membrance and avoid most important in the dressing defective acting on sticking of label.The size of sticking effect depends on the character of label and coating fluid prescription.So one of important indicator of selecting the film coating agent prescription is that film-coat will have the stronger effect of sticking to product surface.In addition, in actual use, the one, note preparing coating liquid; The 2nd, during dressing be born wetting after, should have good bonding force between the chemical group of solid and polymer materials, and also will keep maximum definite contact area.The label auxiliary material also is one of important factor that influences clothing layer bonding strength, mainly is the influence that is subjected to the label property effect and is subjected to tablet surface.So selecting proper supplementary material also is the important process content that solves clothing layer adhesion.As: the tablet that Microcrystalline Cellulose makes shows very high bonding strength; Tablet lubricants selects the stearic acid bonding strength also obviously to strengthen.Obviously, the clothing layer should have stronger bonding strength, and bad bonding strength can cause the film coating defective, as depression, builds bridge etc.

It is Protean that the complicacy of film coating process influences the coating tablet quality, the correlation parameter of label, coating fluid prescription and dressing process has determined the roughness of defective incidence and film-coat, should in real work, note grasping and control, the defective incidence is reduced to minimum, thereby improve the total quality of dressing.

6, film-coated advantage

The existing very long history of China's Chinese patent medicine pill sugar coating, since late 1970s, tablet autogamy coating liquid begins in the part pharmaceutical factory to use, but film coating is a developing direction, these are progressively substituted by film coating agent.

Film coating procedure can be widely used in tablet, pill, granule, and Chinese medicinal tablet particularly strong, easy to crack to water absorbability, piebald more shows its superiority.

Making the disadvantage that uses water as the film coating solvent is that it steams method latent heat than most of organic solvents much higher (approximately being 3 times of alcoholic acid).Ethanol-soluble type moistureproofness Drug coating has contained the whole advantages of water-soluble damp-proof Drug coating, and disadvantage is to use solvent expense height, but because isolation effect is good, and resistance of oxidation is strong, it is softening to avoid occurring in the dressing process medicinal extract, situations such as dressing concave point.

For packing medicinal extract sheet, half medicinal extract sheet, returning effects such as oiliness tablet should be significant.Medicine core oil impregnate, surperficial rich oil and medicine core contain volatile medicine etc., are solvent as painstakingly pursuing with water, and effect is to be difficult to significantly.Often adopt the good Drug coating of ethanol-soluble type moisture effect, can solve the problem of these special labels.So choice of Solvent should mainly be considered medicine core and performance characteristics of colorful coating agent own and needs.

Film coating and sugar coating relatively mainly contain following advantage:

1. quality is good.Because membrane-forming agent and most supplementary additive all are the macromolecular materials of physicochemical property excellence, make the film coated tablet be bundled into not only can protection against the tide, lucifuge, taste masking, wear-resisting, and be difficult for going mouldy, disintegration easily, dissolution rate, bioavailability and the EDD of medicine have been improved greatly, enlarge vendible country of medicine and region greatly, effectively promoted medicine outlet, particularly Chinese patent medicine.

2. weightening finish is few.Only make plate core weight increase by 2%～4%, and sugar coated tablet (wherein main adjunct ingredient is the external talcum powder of having eliminated) often can make label weight increase 50%～100%.

3. fast drying.The dressing operating time is short, generally only need 2～3h, and sugar coating generally needs 16h, and is easy and simple to handle, is easy to grasp, and particularly the Chinese-western medicine to the high temperature destructible is suitable for the preservation quality.

4. figure beauty.The sheet type is attractive in appearance, and lovely luster indicates pure and fresh, vivid.The medicine core can adopt various flat bent moulding, and the trade mark of enterprise, sign can directly be punched on the medicine core, wraps still clearly behind the film-coat obviously not only can improve corporate image, can play anti-fake effect simultaneously.

5. wide in variety.Film coating has numerous materials available, can be made into the film-coat of different characteristics by the design of dressing prescription, with the release position that changes the medicine core and the release characteristics of medicine.Now except that the molten film of stomach, enteric film, also have a mouthful molten film (lozenge), release membranes, release-controlled film, composite membrane (except that the medicine core, also contain other main ingredient in the film) and state-of-the art multilayer film, microporous membrane, osmotic pump dressing, target administration dressing, this makes drug effect improve greatly.

6. use wide.Film coating not only has been widely used in Chinese and western medicine tablet, pill now, and being used for tabloid (Minitablet), pilule (Pellet), granule, soft or hard capsule even drug powder, film forming material also can be directly used in film (as contraceptive membrane, be to contain main ingredient in the film and do not have the medicine core), suspensoid and dewatering medicament dispersion agent etc.

7. stdn.The design of thin membrane coated tablet, technology, material, quality can stdn, and then computerize, and this point is for the GMP management and to enter the world market particularly important.

8. pollute little.Can reduce or avoid the dust from flying in the workshop in the technology, help environmental protection and labour protection, can prevent the workshop internal contamination simultaneously, this requires significant to meeting the GMP cleaning under the current intelligence.

9. solvent is many.Drug coating generally uses water as solvent with the preparation coating liquid, this not only makes cost reduce, and make that operating environment is comparatively comfortable, safety, but fast or meet that water easily decomposes, rotten medicine then can only use non-aqueous solvent to some suction, about a lot of solvents of this respect available.

10. cost is low.Though the thin film coating material price is sugared and talcum powder is expensive, but because consumption is little, and labor savings (1～2 operator), factory building and equipment claimed few (only needing a Standard Factory Room and a coating pan), the economical with materials and the energy are so totally calculate unlike sugar coating cost height.

The moisture-proofing film coating agent more and more is subjected to the welcome of pharmacy producer.Particularly water-soluble moisture-proofing film coating agent should be the dressing auxiliary material of the molten medicine first-selection of stomach, this kind has successfully solved the contradiction that is difficult to be in harmonious proportion between water-soluble, moistureproof, the disintegration three of dressing auxiliary material, stirred 45 minutes as long as Drug coating is added in the water, just be made into homogeneous and long-time not stratified coating liquid, major advantage: the one, do not need fire-protection device, security is good; The 2nd, effective release of medicine; The 3rd, be easy to cleaning equipment; The 4th, good moisture protection; The 5th, save cost and time.

Film coating is a preparation technique that is developing rapidly, by medicine being carried out the outward appearance that the coating clothing can improve label significantly, improves the stability of label, and regulating medicine discharges, outstanding brand image.Cooperate the development of pharmaceutical equipment, film-coated technique can be realized the big production of automatization, and satisfies the requirement of modern GMP to pharmaceutical production equipment and production environment fully, so adopt film coating procedure to become a general development direction of preparation factory.

(2) research overview of film forming material

1, general introduction

Film forming material is divided into gastric solubility film forming material and enteric solubility film forming material two classes again, and its common requirement is that good film-forming properties should be arranged, and excellent mechanical intensity is arranged, the good and ventilation property difference etc. of moistureproofness

2, the type of film forming material, kind and characteristics

1, gastric solubility film forming material: referring in water or gastric juice can the dissolved material, and the dust head has following several.

(1) derivatived cellulose

Vltra tears, hydroxypropylcellulose, Xylo-Mucine etc. all can be made film forming material.

At present most widely used is Vltra tears, and its advantage is to dissolve in some organic solvent and water, easily dissolves in gastric juice, and is little to the detrimentally affect of disintegration of tablet and medicine stripping; Its film-forming properties is better, and the film strength of formation suits, is difficult for embrittlement etc.This product has 3 kinds of models abroad, and is divided into some specifications according to viscosity is different, and its low viscosity person can be used for film coating.Existing HPMC raw material is sold on the market, and the mixture (adding pigment, opalizer titanium dioxide and softening agent etc.) that is made into coating material is also arranged, with preceding solubilizing agent dissolving (suspendible) back dressing.

(2) polyvidone

This product stable in properties, nontoxic can water-soluble and multiple solvent.This product can form firm film, but this product has water absorbability, and this product should be share with other film forming material, for example can share with shellac, glycerol acetate etc., also can share with PEG.

(3) crylic acid resin

Acrylic resin is a big analog copolymer, Dimethylaminoethyl Methacrylate commonly used-neutral methacrylic acid esters multipolymer, and the home made article name is called vinylformic acid IV resin.This product dissolves in organic solvents such as alcohol, acetone, Virahol, trichloromethane, and the solubleness in water is relevant with pH, and solubleness raises because of the pH value descends, rapidly dissolvable in gastric juice, so this product is good gastric solubility coating material.

The film forming properties of this product is better, and film strength is bigger; Can wrap the colorless and transparent film clothing, be used for dressing after also can adding titanium dioxide, colorant and necessary softening agent.

(4) AEA (is called for short: AEA)

The tasteless nothing of this product is smelt, and dissolves in ethanol, methyl alcohol, acetone, the water fast, but dissolve in the sour water its chemical stabilization.

Use this product dressing, can increase performances such as protection against the tide, can dissolve fast under one's belt, less to the detrimentally affect of medicine stripping.

(5) other: as polyoxyethylene glycol etc.

2, enteric solubility film forming material: refer in gastric juice insoluble, but can be in the higher water of pH and intestinal juice in the dissolved film forming material.

(1) shellac (shellac)

This product is insoluble to gastric juice, but the solution more than pH6.4 can dissolve rapidly, can be made into 15%～30% ethanolic soln dressing, and should add suitable softening agent such as castor-oil plant wet goods.

Should note the thickness of coatings in the application, the too thin acidity that can not resist gastric juice too thickly then influences the disintegration of tablet in intestinal juice.This product is dissolved required pH value height, and improper use influences tablet quality; This product is because of the difference of originating, and its performance is variant, uses less in recent years.

(2) the cellulose acetate phthalate (is called for short: CAP)

This product dissolves in the above damping fluid of pH6.0, is to use enteric coatings material more widely at present in the world.This product is the ester class, should note storing, otherwise facile hydrolysis produces free acid and cellulose acetate after the hydrolysis, also do not dissolve in intestinal juice.

This product is once in Chinese widespread use, and the back is restricted because of stability problem makes its popularization, and this product still is enteric solubility film forming material preferably.

(3) acrylic resin

The acrylic resin of enteric solubility is produced in China, is the multipolymer of methacrylic acid-methyl methacrylate, is divided into because of both ratios are different by II number (Eudragit L100 type) and III number (Eudragit S100 type).This resinoid does not all dissolve under one's belt, but can dissolve in pH6 or 7 above damping fluids, safety non-toxic, and the glass transformation temperature height of this product, the fragility of the film of formation is stronger, should add suitable softening agent.

In recent years report, Zoofurin sheet this product dressing, though its dissolution rate is up to specification, bioavailability significantly is lower than with hydroxypropyl methyl cellulose phthalate (abbreviation: HPMCP) dressing person in the human body; Studies have shown that dissolving is slower in the damping fluid of free film more than pH6.0 or 7.0 of this product.

(4) hydroxypropyl methyl cellulose phthalate

This product is stated from the pharmacopeia of a lot of advanced countries such as U.S.P.This product is insoluble to acidic solution, but dissolves in the above damping fluid in pH5～5.8.The film forming properties of this product is good, and the tensile strength of film is big; Safety non-toxic; This product also is an ester compound, but its stability is good than CAP; Can try out in the Zoofurin sheet in the dissolving of small intestine upper end, prove its bioavailability height.

(5) hydroxypropyl methylcellulose acetate succinate (is called for short: HPMCAS)

Be good enteric solubility film forming material, stability is good than CAP and HPMCP.

(3) Study of Plasticizer overview

1, general introduction

All materials that can make polymer materials increase plasticity are called softening agent, and they are boiling point height, more difficult evaporable liquid or low-melting solid normally.

2, the type of softening agent, kind and characteristics

According to the dissolving properties of softening agent, can be divided into water-soluble plasticizer and fat-soluble softening agent (that is: water-insoluble softening agent) two classes.

Water-soluble plasticizer mainly is a multicomponent alcoholics compound, and glycerine, propylene glycol and polyoxyethylene glycol are the water-soluble plasticizers of using always.They can mix with water-soluble polymers such as Vltra tears, can also mix with alcohol soluble polymer such as ethyl cellulose.Under the comparatively high temps in the film coating process, the polyalcohols softening agent is stable, non-volatile.Except that high molecular weight polyethylene glycol, the water absorbability of such softening agent is all stronger, if be 100% with the water absorbability of glycerine, then Macrogol 200,300,400,600 and 1000 water absorbability are respectively 70%, 60%, 55%, 40% and 35%.

Fat-soluble softening agent mainly is the organic carboxyl acid ester compound, comprises glycerine triacetate, citron acid esters, Viscotrol C, phthalic ester and Uniflex DBS etc.Because of its water-insoluble, these softening agent are mainly used in the organic solvent soluble polymer materials, as ethyl cellulose and some enteric film materials etc.But glycerine triacetate and citron acid esters and water have strong avidity, also are used for water-soluble coating material sometimes.In addition, Viscotrol C also has application in fat-soluble softening agent, and is just all less with the intermiscibility of water and organic solvent.

(4) research overview of lubricant

1, general introduction

Lubricant is meant the auxiliary material that can reduce frictional force between particle or tablet etc. and die wall, makes the compressing tablet difficulty greatly to prevent frictional force; Pressure distribution was even when lubricant can make compressing tablet, and made the density of tablet even, and tablet is reduced by releasing required power in the nib.

2, the type of lubricant, kind and characteristics

(1) hydrophobic lubricant

How water insoluble lubricant commonly used be, and majority has stronger hydrophobicity, for example stearic acid, Magnesium Stearate, calcium stearate, talcum powder or the like.

Magnesium Stearate: this product is the fine and smooth easily powder of white, and specific volume is big, and (volume of Magnesium Stearate 1g is 10～15ml), and good tack is arranged, and is not easily separated with being evenly distributed after particle mixes, and is the most frequently used lubricant of China.This product oilness is strong, can reduce the ejection force of tablet significantly; Anti-adhesive is good, prevents the sticking effect, can significantly improve the outward appearance of tablet; Help fluidity poor, if use with other mix lubricant, oilness is better.General consumption is 0.1%～1%, preferred 0.25%～0.5%.Magnesium Stearate is a hydrophobic materials, and stronger hydrophobicity is arranged, and contact angle is 121 °; As improper use, the hydrophobicity of tablet is strengthened, influence the water-wet tablet, consumption too much influences the disintegration time of tablet, the dissolution rate or the generation sliver of medicine, also influences the hardness of tablet etc.When using this hydrophobic lubricant, can add proper amount of surfactant such as sodium lauryl sulphate simultaneously to overcome it.

The character of calcium stearate etc., similar to Magnesium Stearate.

Stearic acid: this product typical concentrations is 1%～5%, and oilness is good, and anti-adhesive is bad, helpless fluidity.Stearic acid also has good lubrication, but than Magnesium Stearate slightly a little less than, this product also has than strong-hydrophobicity, but its contact angle is relative with the detrimentally affect of medicine stripping less to tablet moulding and disintegration than little (980 °) such as Magnesium Stearates; It is block that commercially available stearic acid all is, and being difficult for directly, mill after can being broken for fritter earlier and sneaking into an amount of talcum powder, more easily breaks into fine powder for fine powder; This product is a lipid acid, may react with alkaline medicine.

Talcum powder: this product is white to the canescence crystalline powder, and is good with white person.Density is big, anti-adhesive and help good fluidity, but tack and oilness are relatively poor.General consumption is 3%～6%.Sometimes share with Magnesium Stearate in the production, but have the people to experimental results show that talcum powder has interference to the lubrication of Magnesium Stearate, so had better not be with using.Talcum powder is a hydroaropic substance, does not hinder disintegration of tablet.This product also has micro-alkaline impurities, with preceding earlier with acid treatment to overcome it.

Other also is available as lubricant as Liquid Paraffin, paraffin, glyceryl monostearate, monopalmitin etc.But the hydrophobicity of noting hydrocarbon compound is extremely strong, Ying Shenyong.

High melting-point wax: this product typical concentrations is 3%～5%, and oilness is fine, and anti-adhesive is bad, helpless fluidity.

W-Gum: this product typical concentrations is 3%～10%, helps fluidity, anti-adhesive good, and oilness is bad.

(2) soluble oil

Can be made into solution sheet (or effervescent tablet, dispersible tablet) etc., in order not hinder disintegration of tablet, research and seek soluble oil is subject to people's attention always.

The soluble oil that can Gong select for use is as follows: boric acid, Sodium Benzoate, sodium-acetate, sodium-chlor, polyoxyl 40 stearate, Brij30, DL-leucine, sodium laurylsulfate, magnesium laurylsulfate, Macrogol 4000 or polyethylene glycol 6000.

(5) research overview of tinting material

1, general introduction

Can make material show the material that designing institute needs color, all be called tinting material, it can be an organic or inorganic, also can be natural or synthetic.

2, the type of tinting material, kind and characteristics

Tinting material mainly divides two kinds of pigment and dyestuffs.

(1) pigment

Be the tinting material that can not be dissolved in usual vehicle,, need pigment be dispersed in the plastics with mechanical means so will obtain the ideal tinctorial property.Can be divided into pigment dyestuff and mineral dye by structure.Mineral dye thermostability, light stability are good, and price is low, but the tinting strength relative mistake, relative density is big; Pigment dyestuff tinting strength height, lovely luster, chromatogram is complete, relative density is little, and shortcoming is that thermotolerance, weathering resistance and opacifying power aspect are not as mineral dye.

White pigment mainly contains three kinds of titanium dioxides, zinc oxide, lithopone.Two kinds of structures of divided titanium dioxide rutile-type and anatase titanium dioxide, Rutile type Titanium Dioxide specific refractory power height, opacifying power height, stable, good heat resistance.

Carbon black is a black pigment commonly used, and low price also has UV protection (anti-aging) effect and electric action to plastics in addition, and various processes can obtain the extremely wide various different carbon blacks of particle size range, and nature difference is also very big.Carbon black divides pigment carbon black and used for rubber reinforcement carbon black by purposes, and colour carbon black is divided into high-carbon black pigment, middle colour carbon black and low colour carbon black again by its tinting strength.Carbon black particle is easily assembled, and improve the sooty tinting strength, solve dispersity of carbon black.

Pearly pigment is mica titanium nacreous material again, is a kind of mica wafer of titanium dioxide-coated.According to the form and aspect difference, can be divided into silvery white class pearly pigment, rainbow class pearly pigment, colored class pearly pigment three classes.

(2) dyestuff

Be the organic compound that can be used for most of solvents and be colored plastics, advantage is that density is little, tinting strength is high, transparency is good, but its general molecular structure is little, easily moves when painted.

The chemosynthesis pigment that China allow to use has: amaranth, famille rose, tetraiodofluorescein, newly red, lemon yellow, Sunset yellow, indigo, light blue, and for strengthening above-mentioned water-soluble acid pigment dispersed various pigments in grease.

The self colour that China allow to use have: beet red, lac are red, red pigment of cowberry, capsanthin, red rice are red etc. 45 kinds.

The soluble dye that is meant pigment precipitates in mineral alkali and living pigment, and it is water insoluble.Pigment dyestuff roughly can be categorized as two kinds of pigment lake and paint pigments.

Pigment lake:, water colo(u)r is made water-fast particulate by metal-salt or other precipitation agent.Relatively, pigment itself is the water-insoluble person is called paint pigment.

(6) research overview of opalizer (sunscreen)

1, general introduction

Opalizer is to be used for skin surface to reduce the material of ultraviolet ray or radiation of visible light.For example, the effect of zinc oxide and titanium dioxide is the physical property reflection, and para-amino benzoic acid (para-aminobenzoic acid, abbreviation: then be to absorb solar radiation with its ester class, benzophenone and cinnamate PABA).

According to the difference of wavelength, ultraviolet ray is divided into three kinds:

UVA: this is the longest a kind of ultraviolet ray of wavelength, is not absorbed by the vertical ozonosphere of atmospheric layer, can the transdermal top layer, more can go deep into skin than UVB; Long wave ultraviolet (UVA) is also played a role to the generation of dermatodynia;

UVB: cause the skin sunburn, most of UVB is absorbed by ozonosphere; UVB can evoke the photoresponse of polymorphism day, simple scar rash recurrence and plate-like or systemic lupus erythematous worsens; Experimentation on animals proof UVB irradiation can cause skin carcinoma;

UVC:UVC can almost completely be absorbed by atmospheric layer, has only few situation can go up us and runs into.

UVA can cause different injuries with UVB to skin, and the most serious is exactly skin carcinoma.Many opalizers protect skin not to be subjected to two kinds of ultraviolet rays (UVA, injury UVB) simultaneously.

Research of Harvard Medical School explains that sunscreen is white in color on skin such as zinc oxide, titanium dioxide, can flash back the sunlight, therefore stop light to arrive skin, can effectively protect skin to avoid UVA and UVB injury, these two kinds of ultraviolet rays can cause sunburn and skin carcinoma; And opalizer absorption ultraviolet ray will be more than uv reflectance, and generally colourless, main drawback is just to have decomposed later at the sun exposure several hrs, need smear again.

But according to wide in range definition, sunscreen also can be included in the opalizer in the lump.

Opalizer and can be used for treating photosensitive diseases except that the acute sunburn reaction due to the prevention daylight UVB.In addition, opalizer can be used for preventing skin aging, solar keratosis and skin carcinoma, and experimentation on animals material proof opalizer has the effect of prevention day photic skin carcinoma.

2, classification and common kind

Modal ultraviolet chemical absorption material is a para-amino benzoic acid, absorbs UVB.But PABA causes responsive skin rubescent and irritated easily, as skin sensitivity, answers careful use to contain the opalizer of PABA.

The ultraviolet organism of other absorption also has:

Styracin (Cinnamates) absorbs UVB;

Benzophenone (Benzophenones) absorbs UVA;

Anthranilic acid or cinnamyl o-aminobenzoate (Anthranilates) absorb UVA and UVB simultaneously.

3, the mechanism of action and classification

Opalizer is that a class is used to prevent or weakens ultraviolet goods, comprises inorganic shading composition and organic shading composition two big classes.Wherein:

Inorganic shading composition is inorganics such as zinc oxide, titanium dioxide normally, and they can reflect and the scatters ultraviolet radiation;

Organic shading composition is OMC (octyl methoxycinnamate), hydroxyl benzothiazole (oxybenzone) normally, and they can ultraviolet radiation-absorbing, and quantity of radiant energy is changed into heat energy.

Opalizer plays interception by reflection of light and two kinds of mechanism of absorption are worked by inorganic shading composition and/or organic active shading composition, and general inorganics is a reflex action, and organism is a sorption.

To action of ultraviolet ray or shading mechanism, opalizer mainly is divided into two classes according to opalizer:

(1) UV light absorber

UV light absorber is meant the material that ultraviolet ray is had sorption, the molecular structure of this class material generally has carbonyl conjugation or heterocyclic aromatic organic compounds, its mechanism of action is that the luminous energy that their molecule absorbs from ultraviolet ray excites energy needed to equate with causing molecular photochemistry, can change into heat energy to luminous energy or harmless visible light radiates out, thereby stop action of ultraviolet ray effectively.

(2) ultraviolet screening agent

Ultraviolet screening agent is to utilize some inorganics that ultraviolet scattering of light or reflex action are reduced the infringement of ultraviolet ray to skin, and wherein representational ultraviolet screening agent has titanium dioxide, zinc oxide particle.Sometimes also with mica and metallic compound (TiO with anti-uv-ray ₂, ZnO etc.) mixing, heating, fusion, make the good anti-ultraviolet fine powder bodies of NEW TYPE OF COMPOSITE such as the transparency, wet fastness.They mainly are to form the blocking layer at skin surface, with the antiultraviolet direct irradiation, involve the injury of long wave ultraviolet during the benefit of this opalizer is to prevent simultaneously, shortcoming is that such material consumption is big, shaded effect is relatively poor, and too much use easily causes new problem.

2, common opalizer is formed

(1) salicylate class opalizer

A class UV light absorber early.Itself is very low to ultraviolet absorption ability, and the wavelength region extremely narrow (less than 340nm) that absorbs, and can prevent the ultraviolet ray of 280nm～330rim.But after absorbing certain energy,, formed the strong benzophenone structural of ability and ultraviolet resistance, thereby produced stronger light stabilization because molecular transposition takes place.

Its advantage be low price, gentleness, stable, toxicity is low, can be used with other opalizer.Common have Whitfield's ointment-2-(ethyl hexyl) ester, and consumption also is used for the treatment of light sensation dermatitis simultaneously generally 3%～5%; Salol is also comparatively common in basic shading makeup, and its maximum acceptable concentration in makeup is 1%.Common salicylate class UV light absorber Whitfield's ointment-2-(ethyl hexyl) ester.

(2) Benzophenones derivatives class opalizer

Have two types from structure: a kind of is to have only a vicinal hydroxyl groups, the ultraviolet ray of energy absorbing wavelength 290nm～380nm; Another kind contains two vicinal hydroxyl groups, and the wave band of absorption moves to the long wave direction, the ultraviolet ray of energy absorbing wavelength 300nm～400nm.So Benzophenones derivative UV light absorber is held concurrently and can be absorbed UVA and UVB, is a class wide spectrum UV light absorber.

The shading mechanism of benzophenone analog derivative is that not only hydrogen bond was destroyed after it absorbed UV-light, and carbonyl can be excited generation tautomerism, generation enol-type structure.This class opalizer has very high thermostability and light stability, but to the oxidation instability, so in prescription, must add antioxidant, to reach the effect of fixation.This class opalizer is good to the avidity of skin and mucous membrane, photosensitized reaction can not take place.As 2-hydroxyl-4-methoxyl group benzophenone is a kind of effective wide spectrum UV light absorber, as the oil soluble uv-absorbing agent, uses commonplace abroad usually.4-dimethoxy benzophenone is much the same at the shaded effect in ultraviolet (UV) A district and ultraviolet (UV) B district, and it has higher light and heat stability.Common Benzophenones derivative UV light absorber 2-hydroxyl-4-methoxyl group benzophenone, 2-dihydroxyl-4,4-dimethoxy benzophenone.

Compound in triazine class is a newer class UV light absorber.It is pure dissolubility and oil soluble ultraviolet (UV) Type B absorption agent, but the ultraviolet ray of absorbing wavelength 280nm～320nm.Good with oil soluble composition consistency, the shaded effect excellence.Representation compound wherein has 2,4,6-three (2, the 4-dihydroxy phenyl)-1,3,5-triazines, and this UV light absorber addition is generally about 0.5%～5%.

4, the effectiveness of opalizer

When light contacted with target compound, light was absorbed, and electronics is promoted to higher energy state, perhaps light scatter was opened, and this is with luminous reflectance and reflects the direction of illumination path that changes light again.Take place if having only to absorb, target compound will present transparence so, because the light that is absorbed by target compound still can not be reflected by object or reflect.If scattering, target compound will present translucent or opaque shape so, and this is because light reflects back into the viewer place and causes.Opaque degree depends on the degree size that scattering takes place.And the ability of particle scattered beam depends on their refractive index (nD) and the refractive index (nII) of the medium of particles dispersed.Difference between these two kinds of refractive indexs is big more, and the degree of scattering is also big more so.Suggestion considers that the material of selecting will have high refractive index with the maximization scattered beam.

Equally, because component has different refractive indexs separately, they are the strong scatter visible light line of energy just, thereby makes bulk sample present the opaque white color outward appearance.In shower glue product,, can add a kind of component and make most of light refraction not occur to prevent light from seeing through it, directly reflected back viewer place in order to allow transparent prescription present white and opaque shape.The example of this class component is SYNTRAN, and opalizer is a phenylethylene ethylene/propenoic acid ester copolymer class opalizer.

5, shading product optimization of formulation

Although how shading is still hot issue, under the situation that lacks new shading prescription, emphasis still pays close attention to how to reduce the harm of solar radiation to human skin.

Adopt good method could form a series of shading rule, and be that the method for seeking provides the foundation by the qualitative analysis and the wide spectrum system of absorbancy.The prescription of product has very big influence, TiO to its result of use ₂Have good associativity, TiO with some organism ₂The oil phase that water of forming and organism are formed, the composite good synergetic property that shows of the two makes the shading product have excellent shaded effect.There is unstable in some sunscreen products.Just reported about stoping the interaction with BMDBM from the Eusolex UV-Pe of Merck, thereby improved the photostabilization of EHMc and BMDBM greatly, Octocrilene also can play the effect of stablizing BMDBM.If but that use is not BMDBM but TiO ₂, just might develop high SPF and the prescription of efficiently resisting UVA.The oily matter Rona Care AP that comes from Merck also has the effect that improves BMDBM stability.DHHB is a kind of new fast light organic UVA absorption agent, has fine oil soluble, and energy and TiO ₂With components compatibilities such as ZnO.TiO ₂, 5%DHHB and 2%EHT prescription can make product SPF up to 33, and have good anti-UVA effect, meet European Union fully and recommend requirement.Cmda has released and has contained TiO ₂With the Solaveil Clarus series product of ZnO, this product adopts Optisol-TiO ₂Reaching the light protection that stops free radical to form and wide spectral range is provided with the adulterated mode of manganese, is that 50% inorganic particle is pre-dispersed in the method preparation in the fatty acid carrier with concentration.The manufacturer of Optisol has also released Optisol shading series product, by online spending and obtain various suggestions.

Waterproof is one of mandatory attribute of opalizer, and successful prescription must solve the completely soluble problem of organism.Lelm sun from Inolex contains the deliquescent particulate of superpower oil and has water-proof function.The Inolex publish data shows that when the concentration of Lelm sun in the prescription was 5%, the product water-repellancy satisfied the FDA requirement.

6, the development of opalizer and sunscreen products

Along with the enhancing of people to ultraviolet protection consciousness, the requirement of UV light absorber is also improved constantly, for satisfying people's demand, various countries' researcher is devoted to the exploitation and the research of novel shading agent just untiringly.

(1) nanometer of titanium dioxide, zinc oxide, super-refinement in the physical sunscreen, has the processing that comes to the surface hydrophilic, the oleophylic functional group in the powder surface coating, with suitability that improves powder and the UVA shield effectiveness that under the situation that does not reduce transparency, improves nano titanium oxide, zinc oxide, will be the important research direction of physical sunscreen.

(2) whiten+shading.Because Oriental's majority is a yellow skin, melanin deposition is less, and the main purpose of shading is whitened exactly.The sunscreen products of whitening new trend is: preventative the whitening that will whiten and combine with maintenance with shading, maintenance; The purpose of shading of whitening is not only in order to prevent skin not produce spot, coarse, aging and blackening, more is in order for good and all to make skin health, to keep the health of skin mechanism.

(3) general shading product can be divided into physical property shading product, chemical shading product and mixed type shading product.But physical property shading product uv reflectance, advantage is that gentleness does not stimulate, shortcoming then is thick and heavy, a oil and layer tunica albuginea sense arranged of quality; Chemical shading product then can absorb ultraviolet ray, convert thereof into the material that does not injure skin, and advantage is that salubrious non-greasy does not whiten, and shortcoming then is possible stimulate even cause allergy, and need 30 minutes by effectively shading of ability after the skin absorption.Newer shading product then tend to physical property and chemical mixed type now, not only are fit to general skin matter, and have full efficacies such as anti-UVA, UVB, IR, can reduce pigmentation, delay skin aging and attenuating skin carcinoma odds.

(4) in actual applications, for not dispersed in the water-insoluble that improves small molecules UV light absorber in the makeup, the water and because of molecular mass Xiao Yi is caused phenomenons such as allergic by skin absorption, adopt high molecular or the parent first line of a couplet of UV light absorber with can with macromolecular material mutually the long chain alkane group of mixing to improve consistency; Or connecting water soluble group improves water-insoluble.

(5) release children's shading product.Studies show that: if a people just brings into use the incidence of shading product to 18 year old skin carcinoma will reduce 70% during from children.At present, children's shading product market has accounted for about 4.0～10% of whole shading product market, and will present very fast growth.In a word skin being had better consistency, do not produce side effects such as stimulating allergy, is the developing direction of shading skin care, and the natural sunscreen agent of extracting from natural phant simultaneously also will become emphasis of future research.In addition, shading is not only only in the summer of sweltering heat, and not only skin needs, and shading will be a long-range topic around modern makeup technology and market development.

(7) research overview of lime carbonate

1, general introduction

[Chinese name] lime carbonate [English name] Calcium carbonate

[chemical formula] CaCO ₃[relative molecular mass] 100.09

[proterties] white powder or colourless crystallization.Odorlessness.Tasteless.Two kinds of crystallizations are arranged, and a kind of is quadrature crystal aragonite, and a kind of is six side water chestnut faceted crystal calcites.In the time of about 825 ℃, be decomposed into calcium oxide and carbonic acid gas.Be dissolved in diluted acid, water-soluble hardly.Aragonite: relative density 2.83,825 ℃ of fusing points (decomposition).Calcite: relative density (d25.2) 2.711,1339 ℃ of fusing points (10.39MPa).Pungency is arranged.

[classification] can be water-ground limestone, light calcium carbonate, colloid lime carbonate and crystal calcium carbonate with divided calcium carbonate according to the difference of lime carbonate production method.

2, light calcium carbonate general introduction

Light calcium carbonate claims precipitated chalk again, is called for short fine particle calcium carbonate.

Because ((1.1～1.4mL/g) is big, so be referred to as light calcium carbonate for 2.4～2.8mL/g) settling volumes than heavy lime carbonate for the settling volume of light calcium carbonate.

[preparation method] generates lime (main component is a calcium oxide) and carbonic acid gas with the calcining of raw materials such as Wingdale, add water digestion lime again and generate milk of lime (main component is a calcium hydroxide), and then feed carbonic acid gas carbonization milk of lime and generate precipitation of calcium carbonate, after dehydration, dry and pulverize and make.

Perhaps carry out replacement(metathesis)reaction with yellow soda ash and calcium chloride earlier and generate precipitation of calcium carbonate, make through dehydration, drying and pulverizing then.

[technical process] carborization: be after Wingdale and anthracite are mixed by a certain percentage, through high-temperature calcination, water digestion, carbonic acid gas carbonization, again through centrifuge dehydration, drying, cooling, pulverize, sieving gets product.

CaCO ₃==high temperature==CaO+CO ₂↑

CaO+H ₂O＝＝Ca(OH) ₂

Ca(OH) ₂+CO ₂＝＝CaCO ₃↓+H ₂O

[proterties] white powder.Tasteless, odorless.Proportion about 2.71.825～896.6 ℃ of decomposition, 1339 ℃ of fusing points.Have amorphous and two kinds of forms of crystallization shape, can be divided into rhombic system and hexagonal system again in the crystallization shape, be the column rhombus.Be insoluble in water and alcohol.Be dissolved in acid, emit carbonic acid gas simultaneously, be thermopositive reaction.Also be dissolved in the ammonium chloride solution.Stable in the air, slight moisture absorption ability is arranged.

[purposes] can be used as the filler of industries such as rubber, plastics, papermaking, coating and printing ink.Be widely used in the productions such as organic synthesis, metallurgy, glass and asbestos.Also can be used as neutralizing agent, the gastroduodenal ulcer disease of trade effluent antacid, acidosic toxinicide, contain SO ₂SO in the waste gas ₂The release agent of remover, dairy feed compound and tar felt.The raw material that also can be used as tooth powder, toothpaste and other makeup.

[powder characteristics]

1. the particle shape rule can be considered single and disperses powder, but can be multiple shape, as fusiform, cube, aciculiform, chain, sphere, sheet shape and quadrangular prism shape.These difform lime carbonate can be made by the control reaction conditions.

2. narrower particle size distribution.

3. particle diameter is little, and median size is generally 1～3 μ m.Determine the median size of light calcium carbonate, the minor axis particle diameter in available three particle diameters is got the meta particle diameter as median size again as the performance particle diameter.Generally except that explanation, median size promptly refers to average minor axis particle diameter.

[main application]

1. in 200 orders: can be used for all feeds additive, calcium content reaches more than 55.6%, no oxious component;

2. 250 order to 300 orders: be used as plastic molding and processing plant, rubber plant, coating factory, water-proof material factory raw material and in external rendering, whiteness is more than 85 degree;

3. 350 order to 400 orders: be used to make buckle, water falling pipe, chemical industry, whiteness is more than 93 degree;

4. 400 order to 600 orders: can be used for lotion of toothpaste, soap, whiteness is more than 94 degree;

5. 800 orders: be used for rubber, plastics, cable, PVC, whiteness is more than 94 degree;

6. 1250 orders: PVC, PE, paint, coating level product, papermaking primary coat, paper side are coated with, and whiteness is more than 95 degree.Have high purity, high whiteness, nontoxic, odorless, thin oil, soft;

7. lime carbonate can be made calsium supplement: specific absorption can reach 39%, is only second to calcium citrate malate, dissolves in hydrochloric acid in gastric juice, has become the calsium supplement that formulation is maximum, application is maximum;

8. lime carbonate is alkalescence, is usually used in improveing acid soil;

9. can also be used to producing carbonic acid gas in the laboratory.

By literature search etc., up to the present, still find no the report that new film coating prescription and using method thereof are used in relevant product.

Summary of the invention

The technical problem that will solve required for the present invention has provided new film coating prescription and using method and purposes, and promptly new film coating prescription and the application of using method in relevant product thereof are to overcome the above-mentioned defective that prior art exists.

That is to say, the present invention is directed to the deficiencies in the prior art, by practical studies and theory studies such as experimentation on animals and clinical trials, one of purpose is intended to provide a kind of laminated film coated formula, a kind of laminated film coated formula calciferous promptly is provided, film coating prescription a kind of economy, that be easy to get just is provided, this film-coat composition can with one or more solvent, form high score from, low viscosity and/or low foamy suspension, at the outer dressing that forms rapidly of nuclear core.

Two of purpose of the present invention provides a kind of film coating using method calciferous.

Three of purpose of the present invention provides a kind of film-coated purposes calciferous.

Film coating product of the present invention is meant when the scale operation of industry such as coating, plastics, papermaking, printing-ink, chemical fibre, rubber, makeup, medicine, food, healthcare products and industry, blank nuclear core is carried out the general designation of resulting product behind the film coating, preferred film coated preparation.

(1) technical conceive

Since the thirties in 20th century, occurred relevant film-coated manufacturability successively and explored, but, still can not adapt to production requirement because ground zero is subjected to condition restriction such as thin-film material, art for coating and equipment, its practical application has been subjected to certain restriction.20th century, U.S. Abbott Laboratories pharmaceutical factory (Abbott Lab) at first produced novel film tablet, and obtained patent with " Filmtab " trade mark to the fifties.Through nearly 40 years researchdevelopment, production unit and technology update and perfect, coming out one after another of high molecular film material makes film-coated technique obtain developing rapidly, countries in the world have replaced sugar-coat with film coating basically.

Film-coated technique is a kind of novel packaging technique, and high molecular film material is come out one after another, particularly production unit and technology update and perfect, make film-coated technique obtain developing rapidly.Increasing sharply of the kind of colorful coating agent, quantity not only, quality increases substantially, and kind, form, feature and the Chinese medicine tablet of art for coating, dressing equipment and clothing film, coating of pill or the like all have very big development.Therefore, the applied film packaging technique has become needs and the development trend that pharmacy corporation improves the quality of products.

20 end of the centurys, external colorful coating agent begins a large amount of Chinese Medicine markets that enter, stimulated the development and application of Chinese Drug coating widely, impelled Chinese Medicine research unit, pharmaceutical excipient producer and pharmaceutical factory close fit, made that film-coated technique has obtained developing rapidly.

China just began the starting development in recent years, and the application situation that general medicine essence that film coating is according to the foreign capitals medicine---new drug---is done develops rapidly, has become pharmaceutical industry " new focus ".Along with the paces of implementing GMP are accelerated, the application of China's film-coated technique is in the process of an acceleration, film-coated market outlook are very wide, the perfect raising innovation of coating material and packaging technique is also imperative, and this contriver is being done some explorations aspect the progress of coating material selection, prescription design, packaging technique.

For the film coating process, its successful key just is to use good thin film coating material, a general complete film coating agent mainly comprises membrane-forming agent, softening agent, lubricant, tinting material and opalizer and other subsidiary material etc., in kind with strict compatibility quantitatively all arranged, with guarantee the medicine wicking surface can form one or more layers continuously, fine and close, lasting and clothing film with specific function.So superior in quality colorful film Drug coating should be: not stratified, do not precipitate; Not stifled nozzle; Solid colour; Film forming is fast; Strong adhesion; The clothing film is pliable and tough; Bright and clean even.

The ideal film-coat should be stablized, economy, and preparation is simple, adopts edible or medicinal composition, is convenient to commercial applications.Titanium dioxide is as traditional opalizer, and chemical property is stable, does not react with most of material in the ordinary course of things.At occurring in nature titanium dioxide three kinds of crystallizations are arranged: plate titanium type, sharp titanium and rutile-type.Although it is safe that titanium dioxide is considered to, be used for industry such as coating, plastics, papermaking, printing-ink, chemical fibre, rubber, makeup, it is heavy metal after all, and costs an arm and a leg, it is imperative to seek a kind of safe alternative composition.

And nanometer grade super fine calcium carbonate has ultra-fine, hyperpure characteristics have effectively been controlled its crystalline form and granular size, and have been carried out surface modification in the production process.Therefore, it has the space multistory structure in rubber, and good dispersiveness is arranged again, can improve the strengthening action of material.In makeup, use, because its purity height, good, the fine size of whiteness, also can the instead of titanium white powder etc.

Certainly, film coating agent is not that several auxiliary materials mix arbitrarily, and it is quite complicated that whole process remains, because every kind of auxiliary material all interacts with other auxiliary materials, very big variation has taken place in physical condition and physical relation to each other, as phase transformation, molecule fusion etc.So, the same with new drug development, need a large amount of prescription screenings, seek the auxiliary material that various performances are fit to, constantly adjust the ratio between the auxiliary material, each step also needs the performance test, study on the stability by strictness etc., simultaneously, also to consider the compatibility of itself and various materials, finally obtain a perfect prescription that satisfies technical requirements.

Therefore,, improve and perfect, particularly explore, have very important significance from aspects such as coated formula and using method thereof in conjunction with existing packaging technique.

According to this idea and thinking, the contriver passes through experimental study and analysis and theory study repeatedly, successfully obtains the result of study and the application product of expecting.

(2) film-coated prescription

The present invention has carried out many-sided test and research to existing film coating prescription and using method thereof.

The film-coated prescription of the present invention is achieved by following technical solution.

A kind of film-coated prescription (film coating composition) is provided, it is characterized in that, described composition comprises following component:

(1) polyvalent alcohol

(2) cellulosic polymer

(3) lime carbonate or calcium phosphate

(4) softening agent

(5) lubricant

(6) tinting material

Described composition can be made up of arbitrary composition or composite parts;

Described all the components is including but not limited to edible, medicinal;

Said composition is used to examine the dressing of core, and described nuclear core is to comprise in tablet, capsule, soft capsule or the granule etc. one or more;

(1) described polyvalent alcohol is to comprise in sorbyl alcohol, maltose alcohol or the isomaltose keto-alcohol etc. one or more, preferred sorbyl alcohol;

The amount of described polyvalent alcohol is the weight percent 3%～25% of this film coating composition, preferred 10%;

(2) described cellulosic polymer is to comprise that Vltra tears (is called for short: HPMC), acrylic resin (Eudragit L30D), Sulisi (Aquacoat, Surelease), Eudragit, L.S.RC, HPMC, shellac (Shellac), the polyethylene titanic acid ester (is called for short: PVAP), the cellulose acetate phthalate (is called for short: CAP), 1,2,42 benzene tricarboxylic acid cellulose acetates (are called for short: CAT), the succsinic acid cellulose acetate (is called for short: CAS), Hydroxypropyl Methylcellulose Phathalate (is called for short: HPMCP), 1,2,42 benzene tricarboxylic acid Vltra tearss (are called for short: HPMCT), succsinic acid hydroxypropylmethylcellulose acetate methylcellulose gum (is called for short: one or more in HPMCA S) waiting, preferably Vltra tears;

The amount of described cellulosic polymer is the weight percent 2%～80% of this film coating composition, preferred 45%;

(3) described lime carbonate is to comprise in water-ground limestone, light calcium carbonate, colloid lime carbonate, crystal calcium carbonate or the calcium phosphate etc. one or more, preferred light calcium carbonate, the above light calcium carbonate of further preferred 400 orders, preferred again 1250 purpose light calcium carbonates;

The amount of described lime carbonate is the weight percent 2%～70% of this film coating composition, preferred 35%;

(4) described softening agent is to comprise the propylene glycol dicaprylate, propylene glycol dicaprate, medium chain triglyceride (as: cochin oil), glyceryl monostearate, propylene glycol, polypropylene glycol, polyoxyethylene glycol, vanay, glycerine, Uniflex DBS, triglyceride, the acetylize glycerate, glyceryl monostearate, stearic acid, sorbyl alcohol, tributyl citrate, the acetylize tributyl citrate, adjacent benzene first two dibutyl phthalates, the emulsion of glyceryl monostearate and triethyl citrate, perhaps one or more in their mixture etc., preferred medium chain triglyceride;

The amount of described softening agent is the weight percent 1%～50% of this film coating composition, preferred 10%;

(5) described lubricant is to comprise talcum powder, stearate, silicon-dioxide, sodium stearyl fumarate, palmitinic acid, fatty acid ester, lipid acid, Fatty Alcohol(C12-C14 and C12-C18), mineral oil, paraffin, leucine, polyoxyethylene glycol, dodecyl sulfate, stearic acid, hydrogenated vegetable oil, triethyl citrate, polyoxyethylene glycol 3350, perhaps one or more in their mixture etc., preferred stearic acid;

The amount of described lubricant is the weight percent 1%～5% of this film coating composition, preferred 2%;

(6) described tinting material is to comprise in dyestuff, color lake, pigment, titanium dioxide or the red iron oxide etc. one or more, and tinting material commonly used is to comprise FD﹠amp; C color lake, famille rose, FD﹠amp; C blue No. 1, FD﹠amp; C blue No. 2, FD﹠amp; C red No. 3, FD﹠amp; C red No. 40, FD﹠amp; C yellow No. 5, FD﹠amp; C yellow No. 6, FD﹠amp; In green No. 3 of C, aluminum oxide, talcum, annatto extract, lime carbonate, canthaxanthin, dark reddish brown, β-Hu Luobusu, scarlet, Protosol, turmeric oleoresin, cochineal, Gardenia Yellow, gardenia blue, sugar beet powder, Pericarpium Vitis viniferae extract, riboflavin, purple sweet potato, red sweet potato, chlorophyll extract, spraying drying green, spraying drying carmetta, spraying drying pearl oyster pigment or the natural pigment etc. one or more;

The amount of described tinting material is the weight percent 0.005%～2% of this film coating composition, preferred 1%;

Described film-coated form is preferably the form of coating liquid;

The solvent of described film coating liquid is to comprise in water for injection, the ethanol etc. one or more, preferred water for injection;

The solids content of described film coating liquid 15%～25% solid that is weight percentage, preferred 18% solid;

The viscosity of described film coating liquid is 100～400 centipoises (cps), preferred 300 centipoises;

Described nuclear core with film coating liquid dressing after the weight per-cent 3～15% of gaining in weight;

The film thickness 1 μ m～1000 μ m of described thin film layer, preferred 5 μ m～100 μ m.

For example, all each constituent materialss and proportioning thereof by weight percentage, it is as follows preferably to fill a prescription:

Sorbyl alcohol 8%～15%, Vltra tears 30%～60%, light calcium carbonate 20%～65%, medium chain triglyceride 5%～25%, stearic acid 2%～4%, tinting material 0.5%～1.5%.

Further preferred the prescription as following table:

One of table 1, preferred film-coated prescription

Raw material	Weight (%)
		Sorbyl alcohol	10
Vltra tears	43
		Light calcium carbonate	34
Medium chain triglyceride	10
		Stearic acid	2
Tinting material	1
		Total amount	100

The present invention prepares film-coated equipment and includes but not limited to coating pan, Highefficentcoatingmachine, fluidized-bed, preferred Highefficentcoatingmachine;

(3) film-coated using method

The present invention also provides preparation above-mentioned described film-coated using method, promptly blank nuclear core is carried out film coating, all each constituent materialss and proportioning thereof by above-mentioned prescription by weight for;

This method comprises the steps:

(1) preparation Gonak

With water is solvent, and the dissolving Vltra tears is made into Gonak;

(2) preparation coating liquid

Get above-mentioned Gonak, add light calcium carbonate and stearic acid successively, and then add sorbyl alcohol, tinting material, medium chain triglyceride by required proportioning; Stir, standby as coating liquid behind spheroid mill mill several times;

(3) coating

Blank is examined core place in the dressing production unit, dressing production unit rotating speed is adjusted, after waiting to rotate the some time, spray one deck dries up one deck, and it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; So repeatedly;

Described dressing production unit is to comprise in traditional coating pan, Highefficentcoatingmachine or the fluidized-bed etc. one or more, and preferred Highefficentcoatingmachine further preferably has the eyelet coating pan;

(4) drying

Take out the nuclear core behind the dressing, after the moisture eliminator drying, promptly get and examine the film-coated preparation of core after by film coating.

(3) main application and technology speciality

The present invention provides a kind of new film coating prescription and using method thereof for related productss such as food, medicine, healthcare products, thereby has expanded film-coated application.

Film coating of the present invention is safe, can be used in the scale operation of industry such as coating, plastics, papermaking, printing-ink, chemical fibre, rubber, makeup, medicine, food, healthcare products and industry.

Compare with existing film coating prescription and using method thereof, film coating of the present invention has following distinguishing feature aspect practical application:

(1) film coating prescription of the present invention has substituted expensive titanium dioxide composition with alternative composition lime carbonate inexpensive, safe, that do not contain heavy metal, improved the application surface of product, safe and effective, the scope of application is more extensive, having given its higher practicality, is a kind of film coating that the applications well prospect is arranged;

(2) the preferred especially nano level calcium carbonate superfine powder of film coating prescription of the present invention, this composition has ultra-fine, hyperpure characteristics, its crystalline form and granular size have effectively been controlled in the production process, and carried out surface modification, both had the space multistory structure, good dispersiveness is arranged again, can improve the strengthening action of material; Its purity height, good, the fine size of whiteness also can use in makeup, healthcare products, medicine;

(3) film coating prescription of the present invention is stable, economical, adopts edible or medicinal composition, has reduced its production cost; Preparation technology is simple, and convenient quality control is convenient to enterprise's scale operation and commercial applications; Develop and improve this film coating and have remarkable social benefit, economic benefit.

In a word, active adaption of the present invention the need of work of modern medical service, food, healthcare products and scientific research field and the needs of human nature service, the present invention is these film coatings of research and development, has important value to improving and improving existing this film coating.

Embodiment

The present invention has studied existing film-coated technique, and a kind of film coating prescription of heavy metal free calciferous newly is provided, and is convenient to the safe handling of industries such as medical treatment, food, healthcare products.

Ultimate demand of the present invention is prepared into film-coated preparation and uses, and will enumerate embodiment below and further specify.If any problem, can contact directly 15900897066 with the contriver.Provide several film coating prescriptions and using method and some experimental study contents by aforementioned summary of the invention in above-mentioned some experimental datas that provide and the following example, but the research contents that list in the place that should be appreciated that the present invention is not limited to this, should also be appreciated that term as used herein only is used to describe certain embodiments, and be not limitation of the invention.

, be example now, specifically be described below with the Highefficentcoatingmachine with regard to the film-coated using method of the present invention:

Blank nuclear core is carried out film coating, all each constituent materialss and proportioning thereof by above-mentioned prescription by weight for, concrete steps are:

(1) preparation Gonak

With water is solvent, and the dissolving Vltra tears is made into Gonak; Concrete operations are as follows:

The liquid level of water solvent diameter best and container is roughly the same, and agitator is stretched into 2/3 place under the liquid level; Start agitator, stirring velocity should make the liquid in the container be stirred fully, and liquid level just forms vortex and is advisable; The Vltra tears powder constantly is sprinkling upon on the vortex liquid level with speed stably, and adding speed should be whipped into vortex rapidly with powder and be advisable, and reinforced process should be finished in several minutes; Behind reinforced the finishing, stirring velocity slowed down the liquid level vortex is just disappeared, continue stirring until that Vltra tears is molten fully to loose;

(2) preparation coating liquid

Get above-mentioned Gonak, add light calcium carbonate and stearic acid successively, and then add sorbyl alcohol, tinting material, medium chain triglyceride by required proportioning; Stir, standby as coating liquid after the spheroid mill grinds 3～4 times;

(3) coating

Blank is examined core places in the Highefficentcoatingmachine, the Highefficentcoatingmachine rotating speed is adjusted to 30～50 commentaries on classics/min, wait to rotate 5～10 minutes after, the spray one deck, dry up one deck, it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; So repeatedly;

(4) drying

Take out the nuclear core behind the dressing, dry more than 24 hours at moisture eliminator, promptly get and examine the film-coated preparation of core after by film coating.

In the present invention, the embodiment of above-described embodiment and the following stated all is in order to set forth the present invention better, is not to be used for limiting scope of invention.

Below by embodiment the present invention is described in detail.

Embodiment 1,

Film coating moiety and proportioning:

Table 2, film coating moiety and proportioning

1. be solvent with water for injection, with Vltra tears 6 soaked overnight, fully dissolving is made into Gonak;

2. get above-mentioned Gonak, added the light calcium carbonate and the stearic acid of 80 mesh sieves successively, and then add sorbyl alcohol, FD﹠amp; C blue No. 2, medium chain triglyceride; Stir, standby as coating liquid after the spheroid mill grinds 3～4 times.

3. blank is examined core and is placed in the perforation coating pan, perforation coating pan rotating speed is adjusted to 30～50 commentaries on classics/min, wait to rotate 5～10 minutes after, the spray one deck, dry up one deck, it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; 5 times like this;

4. take out the nuclear core behind the dressing, dry more than 24 hours at moisture eliminator, be the film coating finished product.

Embodiment 2,

Film coating moiety and proportioning:

Table 3, film coating moiety and proportioning

With water for injection is solvent, and with the Vltra tears soaked overnight, fully dissolving is made into Gonak;

Get above-mentioned Gonak, added the light calcium carbonate and the stearic acid of 80 mesh sieves successively, and then add maltose alcohol, sweet sweet potato powder, medium chain triglyceride; Stir, standby as coating liquid after the spheroid mill grinds 3～4 times.

Blank is examined core places in the perforation coating pan, perforation coating pan rotating speed is adjusted to 30～50 commentaries on classics/min, wait to rotate 5～10 minutes after, the spray one deck, dry up one deck, it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; 7 times like this;

Nuclear core behind the taking-up dressing, dry more than 24 hours at moisture eliminator, be the film coating finished product.

Embodiment 3,

Film coating moiety and proportioning:

Table 4, film coating moiety and proportioning

With water for injection is solvent, and with Vltra tears 6 soaked overnight, fully dissolving is made into Gonak;

Get above-mentioned Gonak, added the light calcium carbonate and the stearic acid of 80 mesh sieves successively, and then add sorbyl alcohol, purple sweet potato, medium chain triglyceride; Stir, standby as coating liquid after the spheroid mill grinds 3～4 times.

Blank is examined core places in the no eyelet coating pan, will not have eyelet coating pan rotating speed and be adjusted to 30～50 commentaries on classics/min, wait to rotate 5～10 minutes after, the spray one deck, dry up one deck, it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; 5 times like this;

Nuclear core behind the taking-up dressing, dry more than 24 hours at moisture eliminator, be the film coating finished product.

Embodiment 4,

Film coating moiety and proportioning:

Table 5, film coating moiety and proportioning

With water for injection is solvent, and with Vltra tears 6 soaked overnight, fully dissolving is made into Gonak;

Get above-mentioned Gonak, added the light calcium carbonate and the stearic acid of 80 mesh sieves successively, and then add sorbyl alcohol, medium chain triglyceride; Stir, standby as coating liquid after the spheroid mill grinds 3～4 times.

Blank is examined core places in the perforation coating pan, perforation coating pan rotating speed is adjusted to 30～50 commentaries on classics/min, wait to rotate 5～10 minutes after, the spray one deck, dry up one deck, it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; 3 times like this;

Nuclear core behind the taking-up dressing, dry more than 24 hours at moisture eliminator, be the film coating finished product.

Embodiment 5,

Film coating moiety and proportioning:

Table 6, film coating moiety and proportioning

With water for injection is solvent, and with Vltra tears 6 soaked overnight, fully dissolving is made into Gonak;

Get above-mentioned Gonak, added the light calcium carbonate and the stearic acid of 80 mesh sieves successively, and then add maltose alcohol, medium chain triglyceride; Stir, standby as coating liquid after the spheroid mill grinds 3～4 times.

Blank is examined core places in the perforation coating pan, perforation coating pan rotating speed is adjusted to 30～50 commentaries on classics/min, wait to rotate 5～10 minutes after, the spray one deck, dry up one deck, it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; 7 times like this;

Nuclear core behind the taking-up dressing, dry more than 24 hours at moisture eliminator, be the film coating finished product.

Embodiment 6,

Film coating moiety and proportioning:

Table 7, film coating moiety and proportioning

With water for injection is solvent, and with Vltra tears 6 soaked overnight, fully dissolving is made into Gonak;

Get above-mentioned Gonak, added the light calcium carbonate and the stearic acid of 80 mesh sieves successively, and then add sorbyl alcohol, medium chain triglyceride; Stir, standby as coating liquid after the spheroid mill grinds 3～4 times.

Blank is examined core places in the perforation coating pan, perforation coating pan rotating speed is adjusted to 30～50 commentaries on classics/min, wait to rotate 5～10 minutes after, the spray one deck, dry up one deck, it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; 5 times like this;

Nuclear core behind the taking-up dressing, dry more than 24 hours at moisture eliminator, be the film coating finished product.

Claims (40)

1. a film coating prescription calciferous is characterized in that, described this film coating prescription comprises following component: polyvalent alcohol, cellulosic polymer, lime carbonate or calcium phosphate, softening agent, lubricant and tinting material;

Described polyvalent alcohol is to comprise in sorbyl alcohol, maltose alcohol or the isomaltose keto-alcohol one or more;

Described cellulosic polymer is to comprise Vltra tears, acrylic resin, Sulisi, Eudragit, L.S.RC, HPMC, shellac, polyethylene titanic acid ester, cellulose acetate phthalate, 1,2,42 benzene tricarboxylic acid cellulose acetates, succsinic acid cellulose acetate, Hydroxypropyl Methylcellulose Phathalate, 1, in 2,42 benzene tricarboxylic acid Vltra tearss, the succsinic acid hydroxypropylmethylcellulose acetate methylcellulose gum one or more;

Described lime carbonate is to comprise in water-ground limestone, light calcium carbonate, colloid lime carbonate, crystal calcium carbonate or the calcium phosphate one or more;

Described softening agent is the emulsion that comprises propylene glycol dicaprylate, propylene glycol dicaprate, medium chain triglyceride, glyceryl monostearate, propylene glycol, polypropylene glycol, polyoxyethylene glycol, vanay, glycerine, Uniflex DBS, triglyceride, acetylize glycerate, glyceryl monostearate, stearic acid, sorbyl alcohol, tributyl citrate, acetylize tributyl citrate, adjacent benzene first two dibutyl phthalates, glyceryl monostearate and triethyl citrate, perhaps one or more in their mixture;

Described lubricant is to comprise talcum powder, stearate, silicon-dioxide, sodium stearyl fumarate, palmitinic acid, fatty acid ester, lipid acid, Fatty Alcohol(C12-C14 and C12-C18), mineral oil, paraffin, leucine, polyoxyethylene glycol, dodecyl sulfate, stearic acid, hydrogenated vegetable oil, triethyl citrate, polyoxyethylene glycol 3350, perhaps one or more in their mixture;

Described tinting material is to comprise in dyestuff, color lake, pigment, titanium dioxide or the red iron oxide etc. one or more, and tinting material commonly used is to comprise FD﹠amp; C color lake, famille rose, FD﹠amp; C blue No. 1, FD﹠amp; C blue No. 2, FD﹠amp; C red No. 3, FD﹠amp; C red No. 40, FD﹠amp; C yellow No. 5, FD﹠amp; C yellow No. 6, FD﹠amp; In green No. 3 of C, aluminum oxide, talcum, annatto extract, lime carbonate, canthaxanthin, dark reddish brown, β-Hu Luobusu, scarlet, Protosol, turmeric oleoresin, cochineal, Gardenia Yellow, gardenia blue, sugar beet powder, Pericarpium Vitis viniferae extract, riboflavin, purple sweet potato, red sweet potato, chlorophyll extract, spraying drying green, spraying drying carmetta, spraying drying pearl oyster pigment or the natural pigment one or more.

2. film coating prescription calciferous according to claim 1 is characterized in that the weight percent 3%～25% of the amount of described polyvalent alcohol for this film coating composition.

3. film coating prescription calciferous according to claim 2 is characterized in that, the amount of described polyvalent alcohol is the weight percent 10% of this film coating composition.

4. film coating prescription calciferous according to claim 1 is characterized in that, the amount of described cellulosic polymer is the weight percent 2%～80% of this film coating composition.

5. film coating prescription calciferous according to claim 4 is characterized in that, the amount of described cellulosic polymer is the weight percent 45% of this film coating composition.

6. film coating prescription calciferous according to claim 1 is characterized in that, the amount of described lime carbonate is the weight percent 2%～70% of this film coating composition.

7. film coating prescription calciferous according to claim 6 is characterized in that, the amount of described lime carbonate is the weight percent 35% of this film coating composition.

8. film coating prescription calciferous according to claim 1 is characterized in that, the amount of described softening agent is the weight percent 1%～50% of this film coating composition.

9. film coating prescription calciferous according to claim 8 is characterized in that, the amount of described softening agent is the weight percent 10% of this film coating composition.

10. film coating prescription calciferous according to claim 1 is characterized in that, the amount of described lubricant is the weight percent 1%～5% of this film coating composition.

11. film coating prescription calciferous according to claim 10 is characterized in that, the amount of described lubricant is the weight percent 2% of this film coating composition.

12. film coating prescription calciferous according to claim 1 is characterized in that, the amount of described tinting material is the weight percent 0.005%～2% of this film coating composition.

13. film coating prescription calciferous according to claim 12 is characterized in that, the amount of described tinting material is the weight percent 1% of this film coating composition.

14. film coating prescription calciferous according to claim 1 is characterized in that described polyvalent alcohol is a sorbyl alcohol, described lubricant is a stearic acid.

15. film coating prescription calciferous according to claim 1 is characterized in that described lime carbonate is light calcium carbonate, described softening agent is a medium chain triglyceride.

16. film coating prescription calciferous according to claim 15 is characterized in that, described light calcium carbonate is the above light calcium carbonates of 400 orders, and described medium chain triglyceride is a cochin oil.

17. film coating prescription calciferous according to claim 16 is characterized in that, described light calcium carbonate is the above light calcium carbonates of 1250 orders.

18. film coating prescription calciferous according to claim 1 is characterized in that described film-coated form is preferably the form of coating liquid.

19. film coating prescription calciferous according to claim 18 is characterized in that, the solvent of described film coating liquid is to comprise in water for injection or the ethanol one or more.

20. film coating prescription calciferous according to claim 19 is characterized in that the solvent of described film coating liquid is a water for injection.

21. film coating prescription calciferous according to claim 1 is characterized in that, the solids content of described film coating liquid 15%～25% solid that is weight percentage.

22. film coating prescription calciferous according to claim 21 is characterized in that, the solids content of described film coating liquid 18% solid that is weight percentage.

23. film coating prescription calciferous according to claim 1 is characterized in that the viscosity of described film coating liquid is 100～400 centipoises.

24. film coating prescription calciferous according to claim 23 is characterized in that the viscosity of described film coating liquid is 300 centipoises.

25. film coating prescription calciferous according to claim 1 is characterized in that, described nuclear core with film coating liquid dressing after the weight per-cent 3～15% of gaining in weight.

26. film coating prescription calciferous according to claim 1 is characterized in that, the film thickness 1 μ m～1000 μ m of described thin film layer.

27. film coating prescription calciferous according to claim 26 is characterized in that, the film thickness 5 μ m～100 μ m of described thin film layer.

28., it is characterized in that described this film coating prescription comprises following component according to each described film coating prescription calciferous of claim 1～14:

All each constituent materialss and proportioning thereof by weight percentage, wherein sorbyl alcohol 8%～15%, Vltra tears 30%～60%, light calcium carbonate 20%～65%, medium chain triglyceride 5%～25%, stearic acid 2%～4%, tinting material 0.5%～1.5%.

29. film coating prescription calciferous according to claim 28 is characterized in that, described this film coating prescription comprises following component:

All each constituent materialss and proportioning thereof by weight percentage, wherein sorbyl alcohol 10%, Vltra tears 43%, light calcium carbonate 34%, medium chain triglyceride 10%, stearic acid 2%, tinting material 1%.

30., it is characterized in that described this film-coated using method is promptly carried out film coating to blank nuclear core according to each described film coating prescription calciferous of claim 1 to 14, this method comprises the steps:

(1) preparation Gonak

With water is solvent, and the dissolving Vltra tears is made into Gonak;

(2) preparation coating liquid

Get above-mentioned Gonak, add light calcium carbonate and stearic acid successively, and then add sorbyl alcohol, tinting material, medium chain triglyceride by required proportioning; Stir, standby as coating liquid behind spheroid mill mill several times;

(3) coating

Blank is examined core place in the dressing production unit, dressing production unit rotating speed is adjusted, after waiting to rotate the some time, spray one deck dries up one deck, and it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; So repeatedly;

Described dressing production unit is to comprise in traditional coating pan, Highefficentcoatingmachine or the fluidized-bed etc. one or more, and preferred Highefficentcoatingmachine further preferably has the eyelet coating pan;

(4) drying

Take out the nuclear core behind the dressing, after the moisture eliminator drying, promptly get and examine the film-coated preparation of core after by film coating.

31. film coating prescription calciferous according to claim 30 is characterized in that, the step of described this film-coated using method (1) concrete operations are as follows:

The liquid level of water solvent diameter best and container is roughly the same, and agitator is stretched into 2/3 place under the liquid level; Start agitator, stirring velocity should make the liquid in the container be stirred fully, and liquid level just forms vortex and is advisable; The Vltra tears powder constantly is sprinkling upon on the vortex liquid level with speed stably, and adding speed should be whipped into vortex rapidly with powder and be advisable, and reinforced process should be finished in several minutes; Behind reinforced the finishing, stirring velocity slowed down the liquid level vortex is just disappeared, continue stirring until that Vltra tears is molten fully to loose.

32. film coating prescription calciferous according to claim 30 is characterized in that, the step of described this film-coated using method (3) concrete operations are as follows:

Blank is examined core places in the Highefficentcoatingmachine, the Highefficentcoatingmachine rotating speed is adjusted to 30～50 commentaries on classics/min, wait to rotate 5～10 minutes after, the spray one deck, dry up one deck, it is inter-adhesive to prevent to examine core; Spray one deck again, dry up one deck; So repeatedly.

33. film coating prescription calciferous according to claim 30, it is characterized in that, in the step of described this film-coated using method (4), the nuclear core behind the taking-up dressing, need at moisture eliminator dryly more than 24 hours, promptly get and examine the film-coated preparation of core after by film coating.

34. film coating prescription calciferous according to claim 30 is characterized in that, described nuclear core is to comprise in tablet, capsule, soft capsule or the granule one or more.

35. according to the application of each described film coating prescription calciferous of claim 1 to 14 in preparation film coating product.

36. the application of film coating prescription calciferous according to claim 35, it is characterized in that, described film coating product is meant when the scale operation of coating, plastics, papermaking, printing-ink, chemical fibre, rubber, makeup, medicine, food, healthcare products industry and industry, blank nuclear core carried out the general designation of resulting product behind the film coating.

37. the application of film coating prescription calciferous according to claim 35 is characterized in that described film coating product is a film-coated preparation.

38. the application of composition in preparation film coating product according to each described film coating prescription calciferous of claim 1 to 14.

39. application according to the described film coating prescription calciferous of claim 38, it is characterized in that, described film coating product is meant when the scale operation of coating, plastics, papermaking, printing-ink, chemical fibre, rubber, makeup, medicine, food, healthcare products industry and industry, blank nuclear core carried out the general designation of resulting product behind the film coating.

40. the application according to the described film coating prescription calciferous of claim 38 is characterized in that described film coating product is a film-coated preparation.