CN102949371B - Water resistance type film coating composition and application thereof - Google Patents
Water resistance type film coating composition and application thereof Download PDFInfo
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- CN102949371B CN102949371B CN201210355679.7A CN201210355679A CN102949371B CN 102949371 B CN102949371 B CN 102949371B CN 201210355679 A CN201210355679 A CN 201210355679A CN 102949371 B CN102949371 B CN 102949371B
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Abstract
The invention relates to a coating material, and particularly relates to a water resistance type film coating composition and an application thereof. The water resistance type film coating composition comprises the following components by weight parts: 3-15 parts of polyacrylic resin IV and 1-5 parts of plasticizer which is stearic acid. Before use, the composition is dissolved in an absolute ethyl alcohol, or is mixed together with the absolute ethyl alcohol to be stored or used. The water resistance type film coating composition provided by the invention has an excellent water resistance type performance and good sensitiveness to pH change; and after the medicine is coated according to a conventional film coating technology, the release behavior of the medicine can be obviously improved, the stability of dosage form effervescent tablets sensitive to water and products sensitive to water in the production and storage period is facilitated.
Description
Technical field
The present invention relates to a kind of coating material, particularly a kind of water-resistant type film coating composition and application thereof.
Background technology
Film coating refers to and superscribes one or more layers more stable thin film take macromolecule filming material as main body by some technological means on label, granule or micropill surface.
Film coating originates from Britain, initial object is with pigment, product to be painted, to improve the visual effect of product and the different size of differentiation identical product, nowadays, along with increasing of thin film coating material and additive types, the becoming more meticulous gradually of coating equipment in sugar production line, intellectuality, film coating procedure has been widely used in oral solid formulation such as tablet, granule, micropill, abroad, film coating has replaced sugar coating, domestic, Film coated tablets also has the trend that replaces coated tablet, and nearly all mid-to high-end product has all adopted film-coated technique.
Along with the raising of Living Water product, the mankind are more and more higher to the requirement of medicine.Except curative effect of medication and toxicity are had higher requirement, the comfortableness of medication is also had to more and more higher requirement: adopt film-coated product can completely cut off air and moisture, quite favourable to the stability of product; Film coating can be covered the bad mouthfeel of oral solid formulation, changes oral solid formulation release behavior in vivo and in vitro, and active component is discharged at the position of drafting, and increases the bioavailability of medicine, the object of minimizing toxicity to reach; Meanwhile, also can, by adhering to different colors on thin film coating material, distinguish the different specification of identical product, remind user, avoid as far as possible medication deviation.
Compare traditional coated tablet packaging technique, film-coated technique has unrivaled advantage:
1, sheet type is attractive in appearance, and lovely luster indicates pure and fresh.Label can be pressed into various shapes, and trade mark, the mark of enterprise can directly be punched on label, wraps still clearly after film-coat obviously not only can improve corporate image, can play anti-fake effect simultaneously.
2, with short production cycle, saving energy consumption and artificial, enhances productivity.The film coating operating time is short, generally only need 2～3h, and sugar coating generally needs 6-12h.Easy and simple to handle, be easy to grasp.
3, Product Safety is good.In film coating process, material (30 ~ 50 ℃) under the condition a little more than room temperature can complete technical process, can avoid causing because processing temperature is too high the decomposition of medicine, is conducive to safety and the effectiveness of medicine.
4, product favorable reproducibility.Film coating mechanization, automaticity are high, subtract artificial deviation, improve the quality controllability of product, are conducive to the large production of scale.
Thin film coating material mainly contains filmogen, plasticizer, opacifier, antiplastering aid and pigment composition, filmogen is generally macromolecular material, it is the main material of film coating agent, what frequency of utilization was the highest is hypromellose class, secondly, high replace hyprolose, polyacrylic resin copolymer is also often used, with suitable solvent make filmogen dissolving or swelling after uniformly spray on the surface that is wrapped material, after solvent evaporates, just can form thin film; The object that uses plasticizer is the toughness that increases thin film, reduces the breakage of thin film in processing, storing and use procedure, often adopts Polyethylene Glycol, triacetyl glycerine, citron acid esters, phthalic acid ester and dibutyl sebacate; Opacifier can stop irradiate light product, is conducive to the stability of product, often adopts titanium dioxide as opacifier; Adding antiplastering aid is for fear of the adhesion of product in preparation process, often adopts Pulvis Talci, magnesium stearate to make antiplastering aid; And pigment is in order to increase visual effect and to distinguish specification, often adopt medicinal and food coloring.
In thin film coating material formula, the compatibility between each material is vital; Between each material or additive, the compatibility can form well uniform and stable thin film, otherwise, the thin film of this formation is inhomogeneous stable, affect sensory effects, the dissolubility of film, permeability, the mechanical performance of coating, What is more affects the uniformity of the inside and outside release of product, increases the risk of clinical trial and use.
Summary of the invention
The object of the invention is to solve the bad shortcoming of the existing thin film coating material material of main part that especially water-resistant type, the responsive thin film coating material of pH exist and plasticizer compatbility, a kind of water-resistant type film coating composition is provided.
The present invention also provides described water-resistant type film coating composition preparing the application of pharmaceutical preparations.
The technical solution adopted for the present invention to solve the technical problems is:
A kind of water-resistant type film coating composition, this water-resistant type film coating composition comprises following component by weight: polyacrylic resin Ⅳ 3-15 part, plasticizer 1-5 part, plasticizer is stearic acid.Said composition is dissolved in dehydrated alcohol before using, or is mixed together and preserves or use with dehydrated alcohol.
As preferably, this water-resistant type film coating composition is made up of following component by weight: polyacrylic resin Ⅳ 8-12 part, and plasticizer 2-3 part, plasticizer is stearic acid.
Water-resistant type film coating composition of the present invention, can reduce the potential risk of medicine in production, storage and use procedure, and this point maybe needs the medicine of controlling release to be even more important for some to the high medicine of water sensitivity or dosage form (as effervescent tablet).
Polyacrylic resin Ⅳ is the copolymer of dimethylaminoethyl methacrylate and methacrylic acid lipid, is faint yellow granule or chip solid, is a kind of traditional thin film coating material, to record as pharmaceutic adjuvant into " Chinese Pharmacopoeia " version in 2010.This product (in 1 hour) in warm ethanol is dissolved, and in hydrochloric acid solution (9 → 1000), (in 1 hour) is slightly molten, insoluble in water.This product is alkalescence under normal circumstances, and in " Chinese Pharmacopoeia " version in 2010, the base number of regulation this product is 162.0 ~ 198.0, in this compositions, uses as filmogen.
Dehydrated alcohol is solvent, before use by composition dissolves, makes each component in compositions all be the solution state of high degree of dispersion, guarantees that the thin film after coating is uniform and stable.
Plasticizer is the toughness in order to increase thin film, and guaranteeing to produce, storing and use is the complete of thin film.In the present invention, plasticizer is stearic acid.Stearic acid is the saturated straight chain fatty acid containing 18 carbon atoms.Fusing point is 69.6 ℃, is a kind of main component that forms animal and plant oils and fats, nontoxic, and physicochemical property is stable.There is very strong hydrophobicity.Easily molten, dissolving, almost insoluble in water or acid solution in ethanol in strong base solution.Can be used for the products such as pharmaceutical preparation, ointment, soap and suppository.
Compositions of the present invention is faintly acid under normal circumstances, and " European Pharmacopoeia " 6.5 editions stipulates that its acid number is 194 ~ 212, can form complex with polyacrylic resin Ⅳ, has the good compatibility.
Stearic acid is now generally for as excipient substance, and stearic acid is safe as a kind of common medicinal supplementary material, wide material sources.Because its physicochemical property is special, in pharmaceutical preparation, use usually used as the substrate in sustained-release agent, the semi-solid preparation of lubricant, solid or the semi-solid preparation of solid preparation.
By research, inventor is surprised to find, and stearic acid when the coating material, has not only been played to the effect of plasticizer, and reduced pellicular moisture permeability, can adjust the release behavior of medicine, have surprising superiority.
When water-resistant type film coating composition of the present invention uses, according to proportioning, polyacrylic resin Ⅳ and stearic acid are added respectively in dehydrated alcohol, dissolve in 35 ~ 55 ℃ of stirred in water bath, obtain described compositions.Another kind of selection is according to proportioning, adopts physical method to make composition powder or granule polyacrylic resin Ⅳ and stearic acid, makes solution before use with dehydrated alcohol.
The application of water-resistant type film coating composition in tablet preparation, is specially:
A, proportioning according to claim 1, add polyacrylic resin Ⅳ and stearic acid respectively in dehydrated alcohol, dissolves in 35 ~ 55 ℃ of stirred in water bath, obtains solution A;
B, employing solution A parcel tablet, increasing weight to tablet is 1% ~ 3%(weight);
C, coated with stomach dissolution type material or enteric solubility material again, increasing weight to tablet is 1% ~ 10%(weight), or directly paint with pigment.
As preferably, described stomach dissolution type material is the medicinal stomach dissolution type film-coating premixing material take hypromellose as main body filmogen.Another kind of selection is that enteric solubility material is the medicinal enteric solubility film-coating premixing material take polyacrylic acid resinoid as main body filmogen.
The application of water-resistant type film coating composition in effervescent tablet preparation, with water-resistant type film coating composition parcel effervescent tablet of the present invention, increasing weight to tablet is 1% ~ 3%.
The invention has the beneficial effects as follows: water-resistant type film coating composition water resistance excellence of the present invention, good to pH sensitive, adopt its pass through conventional film coating procedure to medicine coating after, the release behavior of medicine can be significantly improved, be conducive to dosage form effervescent tablet to water sensitive and the production to moisture-sensitive, the stability between the storage life.
Accompanying drawing explanation
Fig. 1 is the not stripping curve of coating sample in different dissolution mediums of the embodiment of the present invention 1;
Fig. 2 is the embodiment of the present invention 1 coating stripping curve of 2% rear sample in different dissolution mediums that increase weight.
The specific embodiment
Below by specific embodiment, technical scheme of the present invention is described in further detail.
In the present invention, if not refer in particular to, raw material and the equipment etc. adopting all can be buied from market or this area is conventional.Method in following embodiment, if no special instructions, is the conventional method of this area.
Embodiment 1: the adjustment to product release behavior after coating
Pinaverium bromide is to act on gastrointestinal spasmolytic, and it is a kind of calcium antagonist, flows into the effect of intestinal smooth cells play by suppressing calcium ion.For the consideration of clinical safety, adopt water-resistant type film coating composition of the present invention to carry out isolation coat to this medicine, cause patient's discomfort to avoid pinaverium bromide to discharge in esophagus.
Getting 2.5 grams of 10 grams of polyacrylic resin Ⅳ, stearic acid is added in 87.5 grams of dehydrated alcohol, after 50 ℃ ~ 55 ℃ stirred in water bath are dissolved, adopt conventional film coating procedure to carry out coating to 200 grams of Pinaverium Bromide Tablets labels (specification 50mg/ sheet), coating sampling during to label weightening finish 1%, 2% and 3%.
Water resisting time test method and criterion: get 20 of testing samples, put respectively in 2 beakers that 200ml water is respectively housed, in every beaker, place 10, in 37 ± 0.5 ℃ of water-baths, be incubated, observe each and break, the time of disintegrate, the water resisting time meansigma methods of 20 should exceed 45 minutes, be less than 20 minutes must not be more than 2, be less than 10 minutes must not be more than 1.
Coating cross-reference data are in table 1 and table 2, Fig. 1 and Fig. 2.Adopt after the film coating procedure coating of the present composition and routine, the release behavior of product is improved.
The impact (static condition water resisting time) on medicine release behavior of table 1, coating
* gain in weight means the actual gain in weight of coating.In table, data are for remaining not rupture diaphragm number (sheet) in cup.
After medicine being coated with by compositions, the water-fast shape of target tablet static condition improves significantly, and has no significant effect in other medium.
The impact (100 revs/min of slurry methods) on product release behavior of table 2, coating
After medicine being coated with by compositions, the hangover of target tablet in water be more than 5 minutes, and all can Fast Stripping in other medium.
Conclusion: adopt after compositions coating, the release in vitro behavior of target tablet be improved significantly, and all can Fast Stripping in other medium.This improvement be conducive to oral cavity, esophagus stimulate large or medicine in oral cavity, esophagus discharges the administration of the medicine that causes untoward reaction, reduces clinical toxicity.
The impact of the coating material of embodiment 2 different proportionings on the tablet water proof time
Getting 2 grams of 8 grams of polyacrylic resin Ⅳ, stearic acid is added in 90 grams of dehydrated alcohol, after 50 ℃ ~ 55 ℃ stirred in water bath are dissolved, adopt conventional film coating procedure to carry out coating to 150 grams of blank labels, coating sampling during to label weightening finish 1%, 2% and 3%.
Coating cross-reference data are in table 3.
The impact (static condition water resisting time) on product release behavior of table 3, coating
* gain in weight means the actual gain in weight of coating.In table, data are for remaining not rupture diaphragm number (sheet) in cup.
Conclusion: adopt after the compositions coating of different proportionings, all can the release of delay product in water.
The impact of the coating material of embodiment 3 different proportionings on the tablet water proof time
Getting 3 grams of 12 grams of polyacrylic resin Ⅳ, stearic acid is added in 85 grams of dehydrated alcohol, after 50 ℃ ~ 55 ℃ stirred in water bath are dissolved, adopt conventional film coating procedure to carry out coating to 150 grams of blank labels, coating sampling during to label weightening finish 1%, 2% and 3%.
Coating cross-reference data are in table 4.
Impact (static condition water resisting time) on product release behavior after table 4, coating
* gain in weight means the actual gain in weight of coating.In table, data are for remaining not rupture diaphragm number (sheet) in cup.
Conclusion: adopt after the compositions coating of different proportionings, all can the release of delay product in water.
Impact on effervescent tablet after embodiment 4 coatings
Getting 2.5 grams of 10 grams of polyacrylic resin Ⅳ, stearic acid is added in 87.5 grams of dehydrated alcohol, after 50 ℃ ~ 55 ℃ stirred in water bath are dissolved, adopt conventional film coating procedure, at relative humidity below 40%, 150 grams of vitamin C effervescent tablet labels (specification 0.1g/ sheet) are carried out to coating, the 1% time sampling of increasing weight of coating to label.
Under the condition of relative humidity 67%, the exposed placement of room temperature is after 60 minutes, and uncoated tablets has collapsed loose, and coated tablet sheet shape is complete.
In 50 ℃ of warm water of 100ml, the time that leaches of 6 uncoated tabletses is 47 seconds, and under the same terms, the time that leaches of 6 coating tablets sheets is 53 seconds.Without significant difference.
In 15 ℃ of warm water of 100ml, the time that leaches of 6 uncoated tabletses is 115 seconds (being less than 3 minutes), and under the same terms, the time that leaches of 6 coating tablets sheets is 164 seconds (being less than 3 minutes).All meet the requirement of version " Chinese Pharmacopoeia " in 2010 to vitamin C effervescent tablet.
Conclusion: after adopting compositions coating, have good block-water effect, be conducive to the stability of effervescent tablet lay up period, and to the use of effervescent tablet without obvious harmful effect.
Impact on sensitive medicaments after embodiment 5 coatings
Getting 2.5 grams of 10 grams of polyacrylic resin Ⅳ, stearic acid is added in 87.5 grams of dehydrated alcohol, after dissolving, 50 ℃ ~ 55 ℃ stirred in water bath obtain composition solution, adopt conventional film coating procedure to carry out coating to 200 grams of chlorophyll copper sodiums (to water sensitive medicine) sheet labels (specification 20mg/ sheet) with said composition solution, coating to label 2% post-drying that increases weight, wrap again gain in weight and be 1% Opadry (Opadry) 03B64919, sampling after drying.
Separately get with batch sample, adopt conventional Opadry for film coating procedure (Opadry) 03B64919 to carry out coating to 200 grams of chlorophyll copper sodiums (to water sensitive medicine) sheet labels (specification 20mg/ sheet), coating to label increases weight after 3% post-drying and samples, and contrasts.
Coating cross-reference data are in table 5 and table 6.
Impact (relative humidity 75%) on product stability after table 5 coating
| ? | 0 |
5 |
10 days |
| Not coating | 12.53% | 11.78% | 11.08% |
| Compositions coating | 12.53% | 12.54% | 12.52% |
| Opadry coating | 12.53% | 12.01% | 11.79% |
* in table, data are the percentage composition of sample Determination of Chlorophyll copper sodium after removal coating.
Impact (relative humidity 92.5%) on product stability after table 6 coating
| ? | 0 |
5 |
10 days |
| Not coating | 12.53% | 11.12% | 10.38% |
| Compositions coating | 12.53% | 12.51% | 12.54% |
| Opadry coating | 12.53% | 11.81% | 11.09% |
* in table, data are the percentage composition of sample Determination of Chlorophyll copper sodium after removal coating.
Conclusion: adopt after compositions coating, have obvious block-water effect, be conducive to the stability in pharmaceutical production, the storage process to water sensitive.
Above-described embodiment is preferably scheme of one of the present invention, not the present invention is done to any pro forma restriction, also has other variant and remodeling under the prerequisite that does not exceed the technical scheme that claim records.
Claims (5)
1. a water-resistant type film coating composition, is characterized in that this water-resistant type film coating composition is made up of following component by weight:
Polyacrylic resin Ⅳ 8-12 part,
Plasticizer 2-3 part, plasticizer is stearic acid.
2. the application of water-resistant type film coating composition in tablet preparation, is characterized in that:
A, proportioning according to claim 1, add polyacrylic resin Ⅳ and stearic acid respectively in dehydrated alcohol, dissolves in 35 ~ 55 ℃ of stirred in water bath, obtains solution A;
B, employing solution A parcel tablet, increasing weight to tablet is 1 % by weight ~ 3 % by weight;
C, coated with stomach dissolution type material or enteric solubility material again, increasing weight to tablet is 1 % by weight ~ 10 % by weight, or directly paints with pigment.
3. application according to claim 2, is characterized in that: described stomach dissolution type material is the medicinal stomach dissolution type film-coating premixing material take hypromellose as main body filmogen.
4. application according to claim 2, is characterized in that: enteric solubility material is the medicinal enteric solubility film-coating premixing material take polyacrylic acid resinoid as main body filmogen.
5. the application of water-resistant type film coating composition in effervescent tablet preparation, is characterized in that: with water-resistant type film coating composition parcel effervescent tablet claimed in claim 1, increasing weight to tablet is 1% ~ 3%.
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| CN106366774A (en) * | 2016-08-26 | 2017-02-01 | 北京英茂药业有限公司 | Coating composition, preparing method and application thereof and glass cleaning effervescent tablets |
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| CN102295788A (en) * | 2011-06-21 | 2011-12-28 | 上海拜瑞曼克生物科技有限公司 | Film coating formula containing calcium carbonate, usage method thereof and purpose thereof |
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| US6723348B2 (en) * | 2001-11-16 | 2004-04-20 | Ethypharm | Orodispersible tablets containing fexofenadine |
| ES2421916T3 (en) * | 2005-03-16 | 2013-09-06 | Nycomed Gmbh | Masked flavor pharmaceutical form containing roflumilast |
| CN101006829B (en) * | 2007-01-26 | 2010-08-11 | 李旭东 | Feed additive for aquaculture covered by high-molecular material |
| CN101548953B (en) * | 2008-04-03 | 2011-10-05 | 上海医药工业研究院 | Medicine granule, preparation method thereof, and preparation containing same |
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| CN102295788A (en) * | 2011-06-21 | 2011-12-28 | 上海拜瑞曼克生物科技有限公司 | Film coating formula containing calcium carbonate, usage method thereof and purpose thereof |
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