CN104107433A - Enteric polymer coating film and preparation method thereof - Google Patents
Enteric polymer coating film and preparation method thereof Download PDFInfo
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- CN104107433A CN104107433A CN201410208623.8A CN201410208623A CN104107433A CN 104107433 A CN104107433 A CN 104107433A CN 201410208623 A CN201410208623 A CN 201410208623A CN 104107433 A CN104107433 A CN 104107433A
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- 229920000642 polymer Polymers 0.000 title claims abstract description 48
- 238000000576 coating method Methods 0.000 title claims abstract description 43
- 239000011248 coating agent Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 20
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims abstract description 169
- 235000019165 vitamin E Nutrition 0.000 claims abstract description 90
- 239000011709 vitamin E Substances 0.000 claims abstract description 90
- 229930003427 Vitamin E Natural products 0.000 claims abstract description 86
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims abstract description 86
- 229940046009 vitamin E Drugs 0.000 claims abstract description 86
- 239000004014 plasticizer Substances 0.000 claims abstract description 62
- 150000002148 esters Chemical class 0.000 claims abstract description 7
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 18
- -1 vitamin E carboxylate Chemical class 0.000 claims description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- ZAKOWWREFLAJOT-CEFNRUSXSA-N D-alpha-tocopherylacetate Chemical compound CC(=O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-CEFNRUSXSA-N 0.000 claims description 15
- ZAKOWWREFLAJOT-UHFFFAOYSA-N d-alpha-Tocopheryl acetate Natural products CC(=O)OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-UHFFFAOYSA-N 0.000 claims description 15
- 229940042585 tocopherol acetate Drugs 0.000 claims description 15
- 239000002253 acid Substances 0.000 claims description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical group CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 12
- 239000003960 organic solvent Substances 0.000 claims description 11
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 10
- 239000001384 succinic acid Substances 0.000 claims description 9
- IQXJCCZJOIKIAD-UHFFFAOYSA-N 1-(2-methoxyethoxy)hexadecane Chemical compound CCCCCCCCCCCCCCCCOCCOC IQXJCCZJOIKIAD-UHFFFAOYSA-N 0.000 claims description 8
- 229950009789 cetomacrogol 1000 Drugs 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 7
- 229920003134 Eudragit® polymer Polymers 0.000 claims description 5
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical group COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims description 5
- 238000013019 agitation Methods 0.000 claims description 5
- 229940088594 vitamin Drugs 0.000 claims description 4
- 229930003231 vitamin Natural products 0.000 claims description 4
- 235000013343 vitamin Nutrition 0.000 claims description 4
- 239000011782 vitamin Substances 0.000 claims description 4
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 4
- 239000003513 alkali Substances 0.000 claims description 3
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 claims description 3
- WSWCOQWTEOXDQX-MQQKCMAXSA-M (E,E)-sorbate Chemical compound C\C=C\C=C\C([O-])=O WSWCOQWTEOXDQX-MQQKCMAXSA-M 0.000 claims description 2
- XDOFQFKRPWOURC-UHFFFAOYSA-N 16-methylheptadecanoic acid Chemical compound CC(C)CCCCCCCCCCCCCCC(O)=O XDOFQFKRPWOURC-UHFFFAOYSA-N 0.000 claims description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 claims description 2
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 150000007942 carboxylates Chemical class 0.000 claims description 2
- 229920002678 cellulose Polymers 0.000 claims description 2
- 229940114123 ferulate Drugs 0.000 claims description 2
- IPCSVZSSVZVIGE-UHFFFAOYSA-M hexadecanoate Chemical compound CCCCCCCCCCCCCCCC([O-])=O IPCSVZSSVZVIGE-UHFFFAOYSA-M 0.000 claims description 2
- OYHQOLUKZRVURQ-IXWMQOLASA-N linoleic acid Natural products CCCCC\C=C/C\C=C\CCCCCCCC(O)=O OYHQOLUKZRVURQ-IXWMQOLASA-N 0.000 claims description 2
- 235000020778 linoleic acid Nutrition 0.000 claims description 2
- 229940049964 oleate Drugs 0.000 claims description 2
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 claims description 2
- 229940075554 sorbate Drugs 0.000 claims description 2
- 150000003712 vitamin E derivatives Chemical class 0.000 claims description 2
- 239000002702 enteric coating Substances 0.000 abstract description 14
- 238000009505 enteric coating Methods 0.000 abstract description 14
- 238000004519 manufacturing process Methods 0.000 abstract description 5
- 231100000419 toxicity Toxicity 0.000 abstract description 5
- 230000001988 toxicity Effects 0.000 abstract description 5
- 239000004925 Acrylic resin Substances 0.000 abstract 3
- 229920000178 Acrylic resin Polymers 0.000 abstract 3
- 238000013329 compounding Methods 0.000 abstract 1
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 description 8
- XNGIFLGASWRNHJ-UHFFFAOYSA-N o-dicarboxybenzene Natural products OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 description 8
- 238000000034 method Methods 0.000 description 7
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
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- 239000002798 polar solvent Substances 0.000 description 3
- 239000002861 polymer material Substances 0.000 description 3
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
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- 230000007613 environmental effect Effects 0.000 description 2
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- 229940011871 estrogen Drugs 0.000 description 2
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- 229920001249 ethyl cellulose Polymers 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 239000004530 micro-emulsion Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- CMXPERZAMAQXSF-UHFFFAOYSA-M sodium;1,4-bis(2-ethylhexoxy)-1,4-dioxobutane-2-sulfonate;1,8-dihydroxyanthracene-9,10-dione Chemical compound [Na+].O=C1C2=CC=CC(O)=C2C(=O)C2=C1C=CC=C2O.CCCCC(CC)COC(=O)CC(S([O-])(=O)=O)C(=O)OCC(CC)CCCC CMXPERZAMAQXSF-UHFFFAOYSA-M 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- FHNINJWBTRXEBC-UHFFFAOYSA-N Sudan III Chemical compound OC1=CC=C2C=CC=CC2=C1N=NC(C=C1)=CC=C1N=NC1=CC=CC=C1 FHNINJWBTRXEBC-UHFFFAOYSA-N 0.000 description 1
- AOBORMOPSGHCAX-UHFFFAOYSA-N Tocophersolan Chemical compound OCCOC(=O)CCC(=O)OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C AOBORMOPSGHCAX-UHFFFAOYSA-N 0.000 description 1
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- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
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- 229920002523 polyethylene Glycol 1000 Polymers 0.000 description 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
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- Medicinal Preparation (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Abstract
The invention relates to an enteric polymer coating film and a preparation method thereof. The enteric polymer coating film comprises one or more plasticizers and one or more polymers. The one or more plasticizers are selected from vitamins E, the one or more polymers are selected from acrylic resin I, acrylic resin II and acrylic resin III, the use mass of the one or more plasticizers is 2-15% total mass of the one or more polymers, and the vitamins E are vitamin E and its esters and comprise fat soluble vitamin E and water-soluble vitamin E. The preparation method utilizes the vitamins E as the plasticizers and solves the problem that in existing enteric coating production, less types of plasticizers are used and toxicity is large. The invention discloses a compounding scheme adopting vitamins E as plasticizers and improves enteric coating film-forming properties and ductility.
Description
Technical field
The present invention relates to enteric polymer clothing film and preparation method thereof, belong to pharmaceutical preparation coating field.
Background technology
Enteric polymer material has good acid resistance, can ensure that enteric coating preparation does not discharge medicine under one's belt, discharges rapidly medicine in intestinal.But plasticity and the ductility of enteric polymer material are poor, need to add a certain amount of plasticizer when coating, improve the film property of coating solution, ensure that clothing film has certain ductility to prevent from breaking.Phthalic acid ester is current the most frequently used plasticizer, is also the legal plasticizer of pharmacopeia, but its is also environmental estrogens simultaneously, is detrimental to health, and causes ecological environmental pollution.In addition, its dispersibility in water is bad, and needing to adopt organic solvent is that disperse medium carries out coating.Other selectable plasticizer kind is limited, and safety using amount is lower.The development and application evaluation of new plasticizer is of great importance to enteric coating.
Natural Vitamin E is conventional nourishing additive agent, and it is the same with phthalic acid ester, is all micromolecule organic ester.Existing document is open: vitamin-e ester and hydroxypropyl cellulose (Repka MA, McGinity JW. Influence of vitamin E TPGS on the properties of hydrophilic films produced by hot-melt extrusion[J].
int J Pharm2000,202 (1-2): 63-70) and ethyl cellulose (Kangarlou S, Haririan I, Gholipour Y. Physico-mechanical analysis of free ethyl cellulose films comprised with novel plasticizers of vitamin resources[J].
int J Pharm, 2008,356 (1-2): 153-166.) there is intermiscibility, can be by vitamin-e ester by hot-melt extruded or be dissolved in the modes such as non-polar solven chloroform and add in cellulosic polymer material, preparation extended release coatings film.So far there is not material open: vitamin E and acrylic polymer have intermiscibility, therefore never vitamin E are mixed to use with acrylic compounds enteric polymer.In addition, there is not so far material open: it is disperse medium that vitamin E can adopt conventional polar solvent, or adopt conventional coating pan and fluid bed preparation to contain the coating clothing film of vitamin E, let alone prepare enteric coating.
The present invention finds first: vitamin E has plasticization to acrylic compounds enteric polymer, a kind of prescription of the enteric coating film containing vitamin E is provided, the present invention further finds: vitamin E composite, be conducive to improve film property and the ductility of enteric coating, prove that vitamin E can be used as the succedaneum of phthalic acid ester completely.The present invention further provides the preparation method of above-mentioned enteric coating.Without adding thermosol extrusion equipment, avoid using the poisonous and harmful solvents such as chloroform, there is good industrialization prospect, economy and social value are huge.
Summary of the invention
The object of the invention is to solve the deficiencies in the prior art, a kind of enteric polymer clothing film is provided.
Another object of the present invention is to provide a kind of preparation method of enteric polymer clothing film.
The technical solution adopted for the present invention to solve the technical problems is:
A kind of enteric polymer clothing film, described enteric polymer clothing film is made up of plasticizer and polymer, and described plasticizer is one or more in vitamin E, and described polymer is Eudragit, one or more in EudragitⅡ or Eudragit Ⅲ, the consumption of described plasticizer is 2 ~ 15% of total polymer mass, described vitamin E is vitamin E and carboxylate thereof, comprises fatsoluble vitamin E and watermiscible vitamin E, and wherein fatsoluble vitamin E comprises: vitamin E, Vitamin E acetate, vitamin E oleate, vitamin E cetylate, vitamin E myristinate, vitamin E linolenin, vitamin E sorbate, vitamin E isostearate, a-Tocopheryl ferulate, vitamin E carboxylate, linoleic acid ester of vitamin e, vitamin E salt acid esters, vitamin E cellulose esters, vitamin E phosphate ester, vitamin E Semen Ricini has acid esters and vitamin E acrylate, and watermiscible vitamin E comprises: VE succinic acid cetomacrogol 1000, vitamin E monoglycosides and vitamin E phosphate ester salt.
Phthalic acid ester is current the most frequently used plasticizer, is also the legal plasticizer of pharmacopeia, but its is also environmental estrogens simultaneously, is detrimental to health, and causes ecological environmental pollution.The present invention chooses one or more in vitamin E as plasticizer through research, and its plasticization effect is good compared with phthalic acid ester, can be used as the succedaneum of phthalic acid ester completely, and economy and social value are huge.
For enteric polymer clothing film of the present invention, its plasticizer has several combination, and while choosing different plasticizers, its preparation method is slightly different, and concrete preparation method is as follows:
The first situation, in the time that disperse medium is ethanol or acetone or both aqueous solutions, plasticizer is one or more in fatsoluble vitamin E, the consumption of plasticizer is 2 ~ 15% of total polymer mass, plasticizer and polymer are dissolved in above-mentioned solvent, mechanical agitation is mixed, and then in 30 ~ 50 DEG C of coatings, coating weightening finish is 5 ~ 10%.It is that main dispersing medium replaces highly toxic non-polar solven chloroform that the technical program is selected hypotoxic polar solvent ethanol or acetone, can at utmost control the toxicity of organic solvent coating, reduce the problems such as solvent recovery, mixed process only needs simple and mechanical mixing, dissolve in coating solution without complex operations such as homogenizing froth breakings, simple to operate, be easy to suitability for industrialized production.
In technique scheme, the ethanol water that organic solvent preferred mass mark is 50 ~ 80%.
The second situation, in the time that disperse medium is water, plasticizer is the mixture of fatsoluble vitamin E and watermiscible vitamin E, by soluble in water to plasticizer and polymer, adds alkali, and mechanical agitation is mixed, and then in 30 ~ 60 DEG C of coatings, coating weightening finish is 8 ~ 20%.The technical program is by by composite to fatsoluble vitamin E and watermiscible vitamin E, only needs simple and mechanical mixing can realize that it is dispersed in water, and compared with existing dispersing mode, simple to operate, effect is good, is suitable for industrialization and amplifies (see and test one).
In the second situation, the composite optimized scope that exists of fatsoluble vitamin E and watermiscible vitamin E, can reduce plasticizer consumption, improves plasticization effect (see experiment two), and the consumption of watermiscible vitamin E accounts for 5% ~ 100% of plasticizer total amount, and preferably 20% ~ 50%.
In technique scheme, the consumption of plasticizer preferably accounts for 2 ~ 10% of total polymer mass.
Taking phthalic acid ester as contrast, taking vitamin E as plasticizer, research above-mentioned two situations make film property, ductility and the acid resistance (seeing experiment three) of enteric coating.Presentation of results: technical scheme disclosed in this invention is respond well, vitamin E can be used as the substitute of phthalic acid ester, for the plasticising of enteric material.
experiment one: vitamin E kind and the consumption impact on dispersibility
Fatsoluble vitamin E is taking Vitamin E acetate as representative, and watermiscible vitamin E is taking VE succinic acid cetomacrogol 1000 as representative.In water, add the vitamin E of variety classes and consumption, mechanical agitation 10min, observes its deployment conditions in water.Wherein Vitamin E acetate is fat sexual element, available tonyred dyeing, convenient observation.
Dispersibility result as shown in Figure 1.Fatsoluble vitamin E is dispersibility extreme difference in water, adopts conventional homogenizing operation cannot disperse (as shown in Figure 1a).Adopt conventional micro-emulsion technology (homogenizing after interpolation Tween 80 emulsifying agent), although make moderate progress, dispersive property not good (as shown in Figure 1 b, mean diameter is 415.6nm, PI=0.361), and small-molecular emulsifier is unfavorable for that enteric coating film is acidproof for a long time.Vitamin E acetate and VE succinic acid cetomacrogol 1000 mix with different ratio, only need standard machinery to stir, just can be in water completely dispersion (mixed proportion is that 5:2 is shown in Fig. 1 c, and mean diameter is 377.7nm, PI=0.315; Mixed proportion is that 1:1 is shown in Fig. 1 d, and mean diameter is 271.0nm, PI=0.303).
experiment two, vitamin E kind and the impact of consumption on film property and ductility
Fatsoluble vitamin E with Vitamin E acetate (taking A acute pyogenic infection of finger tip) as representative, watermiscible vitamin E with VE succinic acid cetomacrogol 1000 (taking B acute pyogenic infection of finger tip) as representative.Taking water as disperse medium, investigate the impact of vitamin E compound scheme on enteric coating film properties.To outward appearance, film property and ductility marking (the results are shown in Table 1), combination property is its total score.
Plasticizer consumption is 2%, 10%, 15%, 20% of polymer total amount; The consumption of B is 0%, 5%, 20%, 50%, 100% of plasticizer total amount.Result of study is in Table 2-3.In the time that plasticizer consumption is 2%, can film forming, but film property is poor, and clothing film is without ductility; In the time that the consumption of B is 0%, outward appearance is inhomogeneous; In the time that the consumption of B is 5%-100%, outward appearance makes moderate progress.In the time that plasticizer consumption is 10%, outward appearance, film property and ductility are all significantly improved; In the time that plasticizer consumption is 15% and 20%, clothing film various aspects of performance is not significantly improved, and considers cost reason, and the plasticizer consumption of optimization is 2-10%.Be 2%, 10%, 15% and 20% 4 kind of situation to plasticizer consumption, when B consumption is 5% ~ 100%, film property and ductility are significantly improved while being all 0% with B consumption.In the time that B consumption is 20% ~ 50%, there is best plasticization effect, if further improve the ratio of watermiscible vitamin E, DeGrain and cost are higher, are 20% ~ 50% therefore watermiscible vitamin E accounts for the preferable range of plasticizer total amount.
Table 1 clothing film properties standard
| Mark | 0 point | 1 point | 2 points | 3 points |
| Outward appearance | Inhomogeneous | More even | Evenly | Very even |
| Film property | Can not film forming | Film property is poor | Film property is better | Film property is fine |
| Ductility | Without ductility | Ductility is poor | Ductility is better | Ductility is fine |
When table 2 plasticizer total amount is 2% and 10%, the impact of watermiscible vitamin E consumption
| Plasticizer total amount | 2% | 10% | ||||||||
| B consumption | 0% | 5% | 20% | 50% | 100% | 0% | 5% | 20% | 50% | 100% |
| Outward appearance | 0 | 1 | 2 | 3 | 3 | 0 | 1 | 2 | 3 | 3 |
| Film property | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 3 | 3 | 3 |
| Ductility | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 3 | 3 |
| Combination property | 1 | 2 | 3 | 4 | 4 | 2 | 5 | 8 | 9 | 9 |
When table 3 plasticizer total amount is 15% and 20%, the impact of watermiscible vitamin E consumption
| Plasticizer total amount | 15% | 20% | ||||||||
| B consumption | 0% | 5% | 20% | 50% | 100% | 0% | 5% | 20% | 50% | 100% |
| Outward appearance | 0 | 1 | 2 | 3 | 3 | 0 | 1 | 2 | 3 | 3 |
| Film property | 1 | 2 | 3 | 3 | 3 | 1 | 2 | 3 | 3 | 3 |
| Ductility | 1 | 2 | 3 | 3 | 3 | 1 | 2 | 3 | 3 | 3 |
| Combination property | 2 | 5 | 8 | 9 | 9 | 2 | 5 | 8 | 9 | 9 |
experiment three: film property and acid resistance
Taking dibutyl phthalate as contrast, taking vitamin E complex as plasticizer, taking EudragitⅡ as enteric polymer, taking 7cm blank as label, adopt pan coating to prepare ECT (the results are shown in Table 4).Observe clothing film configuration of surface, carry out the evaluation of 2h acid resistance according to official method.
Found that: three kinds of coated tablet surfaces are all smooth complete, three kinds of coated tablet 2h in 0.1NHCl still keep complete, ductility, mechanical strength and acid resistance zero difference.Presentation of results: plasticizer performance and the dibutyl phthalate of vitamin E are suitable; But say from plasticizer consumption, the neighbour phthalic acid dibutyl ester of plasticizing efficiency of vitamin E organic solvent coating is good; And the safety non-toxic of vitamin E own, the ethanol consumption in its disperse medium also can reduce.Vitamin E aqueous coatings adopts compound scheme, and compared with vitamin E organic solvent coating, although coating weightening finish slightly increases, disperse medium is water completely, without problems such as any organic solvent toxicity and solvent recovery, can greatly reduce toxicity and the cost of production.
Table 4 enteric coating tablet recipe and result
| Organic solvent coating | Organic solvent coating | Aqueous coatings | |
| Plasticizer kind | Dibutyl phthalate | Vitamin E acetate | Vitamin E acetate: vitamin succinic acid PEG1000=5:2 |
| Disperse medium | Ethanol | 70% ethanol | Water |
| Plasticizer consumption | 15% | 8% | 8% |
| Coating weightening finish | 8% | 8% | 10% |
| Film property | Smooth, complete | Smooth, complete | Smooth, complete |
| Acid resistance (2h) | Qualified | Qualified | Qualified |
The invention has the beneficial effects as follows:
1, a kind of enteric polymer clothing film is disclosed, use first vitamin E for plasticizer, can solve existing enteric coating produce in plasticizer kind few, the problem such as toxicity is large, disclose the compound scheme of vitamin E as plasticizer, can improve film property and the ductility of enteric coating.
2, disclose the preparation method of above-mentioned enteric polymer clothing film, taking conventional polar solvent (mixed liquor of ethanol, acetone and water) as disperse medium, taking conventional pan coating or fluid bed as coating equipment in sugar production line, be applicable to industrialized great production.
Brief description of the drawings
fig. 1 a:vitamin E acetate is dispersive property in water;
Fig. 1 b: Vitamin E acetate adopts conventional micro-emulsion technology dispersive property in water;
Fig. 1 c: Vitamin E acetate: VE succinic acid cetomacrogol 1000=5:2 dispersive property in water;
Fig. 1 d: Vitamin E acetate: VE succinic acid cetomacrogol 1000=1:1 dispersive property in water;
detailed description of the invention
Below by specific embodiment, technical scheme of the present invention is described in further detail.
Embodiment 1: taking Vitamin E acetate: the mixture of VE succinic acid cetomacrogol 1000=1:1 is as plasticizer, plasticizer total amount is 10% of polymer content, polymer is Eudragit, be dissolved in pure water, add alkali liquor, mix homogeneously, is made into polymer quality mark and is 20% aqueous dispersion.At the bottom of adopting fluid bed, spray coating device, in 30 ~ 50 DEG C, micropill is carried out to coating, coating weightening finish 15%.The micropill of wrapping is carried out to acid resistance evaluation according to official method, and after 2h, clothing film is complete, acidproof qualified.
Embodiment 2: taking the Vitamin E acetate of 15% polymer content as plasticizer, polymer is EudragitⅡ, is dissolved in 75% alcoholic solution, and mix homogeneously is made into polymer quality mark and is organic coating solution of 10%.Coating device is high-efficiency rotating coating pan, in 40 ~ 50 DEG C of coatings, and coating weightening finish 8%.The tablet of wrapping is carried out to acid resistance evaluation according to official method, and after 2h, clothing film is complete, acidproof qualified.
Embodiment 3: taking the Vitamin E acetate of 10% polymer content as plasticizer, polymer is EudragitⅡ, is dissolved in 50% acetone soln, and mix homogeneously is made into polymer quality mark and is organic coating solution of 10%.Coating device is high-efficiency rotating coating pan, in 40 ~ 50 DEG C of coatings, and coating weightening finish 9.5%.The tablet of wrapping is carried out to acid resistance evaluation according to official method, and after 2h, clothing film is complete, acidproof qualified.
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 (6)
1. an enteric polymer clothing film, described enteric polymer clothing film is made up of plasticizer and polymer, it is characterized in that: described plasticizer is one or more in vitamin E, and described polymer is Eudragit, one or more in EudragitⅡ or Eudragit Ⅲ, the consumption of described plasticizer is 2 ~ 20% of total polymer mass, described vitamin E refers to vitamin E and carboxylate thereof, comprises fatsoluble vitamin E and watermiscible vitamin E, and wherein fatsoluble vitamin E comprises: vitamin E, Vitamin E acetate, vitamin E oleate, vitamin E cetylate, vitamin E myristinate, vitamin E linolenin, vitamin E sorbate, vitamin E isostearate, a-Tocopheryl ferulate, vitamin E carboxylate, linoleic acid ester of vitamin e, vitamin E salt acid esters, vitamin E cellulose esters, vitamin E phosphate ester, vitamin E Semen Ricini has acid esters and vitamin E acrylate, and watermiscible vitamin E comprises: VE succinic acid cetomacrogol 1000, vitamin E monoglycosides and vitamin E phosphate ester salt.
2. the preparation method of an enteric polymer clothing film claimed in claim 1, it is characterized in that: described preparation method is as follows: plasticizer and polymer are dissolved in organic solvent, mechanical agitation is mixed, then in 30 ~ 50 DEG C of coatings, described plasticizer is one or more in fatsoluble vitamin E, described organic solvent is ethanol or acetone or both aqueous solutions, and coating weightening finish is 5 ~ 10%.
3. the preparation method of enteric polymer clothing film according to claim 2, is characterized in that: the ethanol water that described organic solvent preferred mass mark is 50 ~ 80%.
4. the preparation method of an enteric polymer clothing film claimed in claim 1, it is characterized in that: described preparation method is as follows: by soluble in water to plasticizer and polymer, add alkali, mechanical agitation is mixed, then in 30 ~ 60 DEG C of coatings, described plasticizer is the mixture of fatsoluble vitamin E and watermiscible vitamin E, and coating weightening finish is 8 ~ 20%.
5. the preparation method of enteric polymer clothing film according to claim 4, is characterized in that: the consumption of described plasticizer preferably accounts for 2 ~ 10% of total polymer mass.
6. according to the preparation method of the enteric polymer clothing film described in claim 4 or 5, it is characterized in that: the consumption of described watermiscible vitamin E accounts for 5% ~ 100% of plasticizer total amount.
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| CN110372893A (en) * | 2019-07-26 | 2019-10-25 | 蓝帆医疗股份有限公司 | A kind of butyronitrile gloves and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110372893A (en) * | 2019-07-26 | 2019-10-25 | 蓝帆医疗股份有限公司 | A kind of butyronitrile gloves and preparation method thereof |
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