CN104107433B - Enteric polymer coating film and preparation method thereof - Google Patents
Enteric polymer coating film and preparation method thereof Download PDFInfo
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- CN104107433B CN104107433B CN201410208623.8A CN201410208623A CN104107433B CN 104107433 B CN104107433 B CN 104107433B CN 201410208623 A CN201410208623 A CN 201410208623A CN 104107433 B CN104107433 B CN 104107433B
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- 229920000642 polymer Polymers 0.000 title claims abstract description 45
- 238000000576 coating method Methods 0.000 title claims abstract description 35
- 239000011248 coating agent Substances 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 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 142
- 235000019165 vitamin E Nutrition 0.000 claims abstract description 79
- 239000011709 vitamin E Substances 0.000 claims abstract description 79
- 229930003427 Vitamin E Natural products 0.000 claims abstract description 75
- 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 75
- 229940046009 vitamin E Drugs 0.000 claims abstract description 75
- 239000004014 plasticizer Substances 0.000 claims abstract description 58
- -1 Vitwas E Chemical compound 0.000 claims description 21
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 18
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 17
- 239000002253 acid Substances 0.000 claims description 13
- 230000004584 weight gain Effects 0.000 claims description 8
- 235000019786 weight gain Nutrition 0.000 claims description 8
- 239000001384 succinic acid Substances 0.000 claims description 7
- IQXJCCZJOIKIAD-UHFFFAOYSA-N 1-(2-methoxyethoxy)hexadecane Chemical compound CCCCCCCCCCCCCCCCOCCOC IQXJCCZJOIKIAD-UHFFFAOYSA-N 0.000 claims description 6
- 229950009789 cetomacrogol 1000 Drugs 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 5
- 229920003134 Eudragit® polymer Polymers 0.000 claims description 4
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical group COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims description 4
- 238000013019 agitation Methods 0.000 claims description 4
- 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
- JUIUXBHZFNHITF-IEOSBIPESA-N [(2r)-2,5,7,8-tetramethyl-2-[(4r,8r)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] dihydrogen phosphate Chemical compound OP(=O)(O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C JUIUXBHZFNHITF-IEOSBIPESA-N 0.000 claims description 3
- 239000003513 alkali Substances 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
- 229920002678 cellulose Polymers 0.000 claims description 2
- 229940114123 ferulate Drugs 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
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 claims description 2
- 229940075554 sorbate Drugs 0.000 claims description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 claims 1
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 claims 1
- 239000011347 resin Substances 0.000 claims 1
- 229920005989 resin Polymers 0.000 claims 1
- 229940066675 ricinoleate Drugs 0.000 claims 1
- 239000002702 enteric coating Substances 0.000 abstract description 11
- 238000009505 enteric coating Methods 0.000 abstract description 11
- 229920000178 Acrylic resin Polymers 0.000 abstract description 6
- 239000004925 Acrylic resin Substances 0.000 abstract description 6
- 150000002148 esters Chemical class 0.000 abstract description 6
- 238000004519 manufacturing process Methods 0.000 abstract description 6
- 238000013329 compounding Methods 0.000 abstract description 5
- 231100000419 toxicity Toxicity 0.000 abstract description 5
- 230000001988 toxicity Effects 0.000 abstract description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 13
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 8
- 238000000034 method Methods 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
- 239000003960 organic solvent Substances 0.000 description 7
- 239000000243 solution Substances 0.000 description 7
- 229960005137 succinic acid Drugs 0.000 description 7
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 6
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 description 6
- 238000002474 experimental method Methods 0.000 description 6
- 239000002904 solvent Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 241000894007 species Species 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 239000012530 fluid Substances 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 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
- 230000001627 detrimental effect Effects 0.000 description 2
- 239000006185 dispersion Substances 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000003995 emulsifying agent Substances 0.000 description 2
- 238000003912 environmental pollution Methods 0.000 description 2
- 229940011871 estrogen Drugs 0.000 description 2
- 239000000262 estrogen Substances 0.000 description 2
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 description 2
- 229920001249 ethyl cellulose Polymers 0.000 description 2
- 235000019325 ethyl cellulose Nutrition 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 210000000936 intestine Anatomy 0.000 description 2
- 239000004530 micro-emulsion Substances 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
- HBGPNLPABVUVKZ-POTXQNELSA-N (1r,3as,4s,5ar,5br,7r,7ar,11ar,11br,13as,13br)-4,7-dihydroxy-3a,5a,5b,8,8,11a-hexamethyl-1-prop-1-en-2-yl-2,3,4,5,6,7,7a,10,11,11b,12,13,13a,13b-tetradecahydro-1h-cyclopenta[a]chrysen-9-one Chemical compound C([C@@]12C)CC(=O)C(C)(C)[C@@H]1[C@H](O)C[C@]([C@]1(C)C[C@@H]3O)(C)[C@@H]2CC[C@H]1[C@@H]1[C@]3(C)CC[C@H]1C(=C)C HBGPNLPABVUVKZ-POTXQNELSA-N 0.000 description 1
- PFRGGOIBYLYVKM-UHFFFAOYSA-N 15alpha-hydroxylup-20(29)-en-3-one Natural products CC(=C)C1CCC2(C)CC(O)C3(C)C(CCC4C5(C)CCC(=O)C(C)(C)C5CCC34C)C12 PFRGGOIBYLYVKM-UHFFFAOYSA-N 0.000 description 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 206010021703 Indifference Diseases 0.000 description 1
- SOKRNBGSNZXYIO-UHFFFAOYSA-N Resinone Natural products CC(=C)C1CCC2(C)C(O)CC3(C)C(CCC4C5(C)CCC(=O)C(C)(C)C5CCC34C)C12 SOKRNBGSNZXYIO-UHFFFAOYSA-N 0.000 description 1
- 235000004443 Ricinus communis Nutrition 0.000 description 1
- 240000000528 Ricinus communis Species 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
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 150000007942 carboxylates Chemical group 0.000 description 1
- JBTHDAVBDKKSRW-UHFFFAOYSA-N chembl1552233 Chemical compound CC1=CC(C)=CC=C1N=NC1=C(O)C=CC2=CC=CC=C12 JBTHDAVBDKKSRW-UHFFFAOYSA-N 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000009474 hot melt extrusion Methods 0.000 description 1
- 239000012943 hotmelt Substances 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 150000002632 lipids Chemical group 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 230000007096 poisonous effect Effects 0.000 description 1
- 229920000058 polyacrylate Polymers 0.000 description 1
- 229920002523 polyethylene Glycol 1000 Polymers 0.000 description 1
- 229940113116 polyethylene glycol 1000 Drugs 0.000 description 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
- 229920000053 polysorbate 80 Polymers 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000007634 remodeling Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 229940073450 sudan red Drugs 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 150000003712 vitamin E derivatives Chemical class 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 fields.
Background technology
Enteric polymer material has good acid resistance it is ensured that enteric coated formulation does not discharge medicine under one's belt,
Rapid release medicine in intestines.But the plasticity of enteric polymer material and ductility are poor, need to add a certain amount of during coating
Plasticizer, improves the film forming of coating solution it is ensured that clothing film has certain ductility to prevent from rupturing.Phthalic acid ester is at present
Conventional plasticizer, is also the legal plasticizer of pharmacopeia, but it is also environmental estrogens, is detrimental to health simultaneously, and cause
Ecological environmental pollution.Additionally, its poor dispersion in water, need to be coated for decentralized medium using organic solvent.Other can
The plasticizer limitednumber selecting, safety using amount is relatively low.The development and application evaluation of new plasticizer has great to enteric coating
Meaning.
Natural VE is conventional nourishing additive agent, and it is all small molecule organic ester as phthalic acid 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 Pharm, 2000, 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, vitamin-e ester can be squeezed by hot melt
Go out or be dissolved in the modes such as non-polar solven chloroform to add in cellulosic polymer material, preparation sustained release clothing film.So far there is not material
Material is open：Vitamin E and acrylic polymer have intermiscibility, therefore never by vitamin E and acrylic compounds enteric polymer
It is used in mixed way.Additionally, there not being material open so far：Vitamin E can be decentralized medium using conventional polar solvents, or using conventional
The coating pan and fluid bed preparation coating clothing film containing vitamin E, let alone prepare enteric coating.
Present invention firstly discovers that：Vitamin E has plasticization to acrylic compounds enteric polymer, there is provided one kind is containing dimension
The prescription of the enteric coating film of raw element E, the present invention is further discovered that：Compounding of vitamin E, is conducive to improving the one-tenth of enteric coating
Film and ductility are it was demonstrated that vitamin E completely can be used as the substitute of phthalic acid ester.Invention further provides on
State the preparation method of enteric coating.Thermosol extrusion equipment need not be added, it is to avoid using the poisonous and harmful solvent such as chloroform, have good
Industrialization prospect, economy and social value huge.
Content of the invention
It is an object of the invention to solution the deficiencies in the prior art, provide a kind of enteric polymer clothing film.
Further object is that providing 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, described plasticizer
For one or more of vitamin E, described polymer is Eudragit, EudragitⅡ or acrylic resin
One or more of No. III, the consumption of described plasticizer is the 2 ~ 15% of total polymer mass, and described vitamin E is vitamin E
And its carboxylate, including liposoluble vitamin E and watermiscible vitamin E, wherein liposoluble vitamin E includes：Vitamin E, dimension
Raw element E acetate, vitamin E oleate, tocopheryl palmitate, vitamin E myristinate, vitamin E linolenin,
Vitamin E sorbate, vitamin E isostearate, a-Tocopheryl ferulate, vitamin E carboxylate, vitamin E linoleic acid
Ester, vitamin E salt acid esters, Vitamin E cellulose ester, vitamin E phosphate, vitamin E castor-oil plant have acid esters and vitamin E propylene
Acid esters, watermiscible vitamin E includes：VE succinic acid cetomacrogol 1000, vitamin E monoglycosides and vitamin E phosphate
Salt.
Phthalic acid ester is plasticizer the most frequently used at present, is also the legal plasticizer of pharmacopeia, but it is also ring simultaneously
Border estrogen, is detrimental to health, and causes ecological environmental pollution.The present invention through research choose one of vitamin E or
Several as plasticizer, its plasticization effect is good compared with phthalic acid ester, completely can be used as the substitute of phthalic acid ester, warp
Ji and social value are huge.
For the enteric polymer clothing film of the present invention, its plasticizer has several combination, when choosing different plasticizer, its
Preparation method is slightly different, and concrete preparation method is as follows：
The first situation, when decentralized medium is for ethanol or acetone or both aqueous solution, plasticizer is fat-soluble dimension life
One or more of plain E, the consumption of plasticizer is the 2 ~ 15% of total polymer mass, plasticizer and polymer is dissolved in above-mentioned
In solvent, mechanical agitation mixes, and is then coated in 30 ~ 50 DEG C, and coating weight gain is 5 ~ 10%.The technical program is selected hypotoxic
Polar solvent ethanol or acetone replace highly toxic non-polar solven chloroform for main dispersing medium, and can at utmost control has
The toxicity of machine solvent coating, the problems such as reduce solvent recovery, mixed process only needs simple and mechanical mixing, multiple without homogeneous froth breaking etc.
Miscellaneous operation dissolves in coating solution, simple to operate it is easy to industrialized production.
In technique scheme, organic solvent preferred mass fraction is 50 ~ 80% ethanol water.
Second situation, when decentralized medium is for water, plasticizer is the mixed of liposoluble vitamin E and watermiscible vitamin E
Compound, will be soluble in water to plasticizer and polymer, plus alkali, and mechanical agitation mixes, and is then coated in 30 ~ 60 DEG C, and coating weight gain is 8
~20%., by compounding liposoluble vitamin E with watermiscible vitamin E, the only simple and mechanical mixing of need can be real for the technical program
Its dispersed in water, compared with existing dispersing mode, simple to operate, excellent effect existing, is suitable to industrialization and amplifies（See experiment
One）.
In second situation, there is optimized scope in liposoluble vitamin E and the compounding of watermiscible vitamin E, can reduce increasing
Mould agent consumption, improve plasticization effect（See experiment two）, the consumption of watermiscible vitamin E accounts for the 5% ~ 100% of plasticizer total amount, excellent
Select 20% ~ 50%.
In technique scheme, the consumption of plasticizer preferably accounts for the 2 ~ 10% of total polymer mass.
With phthalic acid ester for comparison, with vitamin E as plasticizer, research above-mentioned two situations are obtained enteric coating
Film forming, ductility and acid resistance（See experiment three）.Result explanation：Technical scheme disclosed in this invention is respond well, dimension life
Plain E can be as the substitute of phthalic acid ester, for the plasticising of enteric material.
Experiment one：Vitamin E species and consumption are to dispersed impact
, with Vitwas E as representative, watermiscible vitamin E is with the poly- second of VE succinic acid two for liposoluble vitamin E
Alcohol 1000 is representative.Add the vitamin E of variety classes and consumption, mechanical agitation 10min in water, observe its dividing in water
Scattered situation.Wherein Vitwas E is lipid composition, available the Sudan red colouring, convenient observation.
Dispersed result is as shown in Figure 1.Liposoluble vitamin E dispersed extreme difference in water, is operated no using conventional homogeneous
Method is disperseed（As shown in Figure 1a）.Using conventional microemulsion technology（Add homogeneous after Tween 80 emulsifying agent）Although making moderate progress, but
Dispersive property is not good（As shown in Figure 1 b, average grain diameter is 415.6nm, PI=0.361）, and small-molecular emulsifier is unfavorable for enteric
Coating membrane is acidproof for a long time.Vitwas E and VE succinic acid cetomacrogol 1000 mix in different proportions, only need
Standard machinery stirs, and just can be completely dispersed in water（Mixed proportion is 5:2 see Fig. 1 c, and average grain diameter is 377.7nm, PI=
0.315；Mixed proportion is 1:1 sees Fig. 1 d, and average grain diameter is 271.0nm, PI=0.303）.
Experiment two, the impact to film forming and ductility of vitamin E species and consumption
Liposoluble vitamin E is with Vitwas E（With A acute pyogenic infection of finger tip）For representing, watermiscible vitamin E is with vitamin E amber
Amber acid polyethylene glycol 1000（With B acute pyogenic infection of finger tip）For representing.With water as decentralized medium, investigate vitamin E compound scheme to enteric clothing film
The impact of performance.Outward appearance, film forming and ductility are given a mark（The results are shown in Table 1）, combination property is its total score.
Plasticizer consumption is 2%, 10%, 15%, the 20% of polymer total amount；The consumption of B be plasticizer total amount 0%, 5%,
20%、50%、100%.Result of study is shown in Table 2-3.When plasticizer consumption is 2%, can film forming, but film forming is poor, and clothing film is no prolonged
Malleability；When the consumption of B is 0%, outward appearance is uneven；When the consumption of B is 5%-100%, outward appearance makes moderate progress.When plasticizer is used
When measuring as 10%, outward appearance, film forming and ductility are all significantly improved；When plasticizer consumption is 15% and 20%, clothing film each side
Performance does not significantly improve it is contemplated that cost reason, and the plasticizer consumption of optimization is 2-10%.To plasticizer consumption be 2%, 10%,
15% and 20% 4 kind of situation, when B consumption is 5% ~ 100%, film forming and ductility all with B consumption for 0% when be significantly improved.Work as B
Consumption be 20% ~ 50% when, there is optimal plasticization effect, if further improve watermiscible vitamin E ratio, DeGrain and
Relatively costly, therefore the preferred scope that watermiscible vitamin E accounts for plasticizer total amount is 20% ~ 50%.
Table 1 clothing film performance standard
| Fraction | 0 point | 1 point | 2 points | 3 points |
| Outward appearance | Uneven | More uniform | Uniformly | Very uniform |
| Film forming | It is unable to film forming | Film forming is poor | Film forming is preferable | Film forming is fine |
| Ductility | No ductility | Ductility is poor | Ductility is preferable | 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 forming | 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 forming | 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 forming and acid resistance
With dibutyl phthalate for comparison, with vitamin E compound as plasticizer, with EudragitⅡ as intestines
Insoluble polymer, with 7cm blank as label, prepares ECT using pan coating（The results are shown in Table 4）.Observe clothing film surface shape
State, carries out 2h acid resistance evaluation according to official method.
It is found that:Three kinds of coating tablet surfaces are all smooth complete, and three kinds of coating tablet 2h in 0.1NHCl still keep complete,
Ductility, mechanical strength and acid resistance indifference.Result explanation：The plasticizer performance of vitamin E and dibutyl phthalate
Quite；But for plasticizer consumption, near the plasticizing efficiency of vitamin E organic solvent coating, dibatyl phithalate is good；And
And vitamin E safety non-toxic itself, the ethanol consumption in its decentralized medium also can reduce.Vitamin E aqueous coatings are using compounding
Scheme, although coating weight gain slightly increases compared with vitamin E organic solvent coating, but decentralized medium is entirely water, no any
The problems such as organic solvent toxicity and solvent recovery, toxicity and the cost of production can be substantially reduced.
Table 4 enteric coating tablet recipe and result
| Organic solvent is coated | Organic solvent is coated | Aqueous coatings | |
| Plasticizer species | Dibutyl phthalate | Vitwas E | Vitwas E：Vitamin butanedioic acid PEG1000=5:2 |
| Decentralized medium | Ethanol | 70% ethanol | Water |
| Plasticizer consumption | 15% | 8% | 8% |
| Coating weight gain | 8% | 8% | 10% |
| Film forming | Smooth, complete | Smooth, complete | Smooth, complete |
| Acid resistance（2h） | Qualified | Qualified | Qualified |
The invention has the beneficial effects as follows：
1st, disclose a kind of enteric polymer clothing film, the use of vitamin E is plasticizer first, it is possible to resolve existing enteric coating
In production, plasticizer species is few, the problems such as toxicity is big, discloses vitamin E as the compound scheme of plasticizer, can improve enteric
The film forming of coating and ductility.
2nd, disclose the preparation method of above-mentioned enteric polymer clothing film, with conventional polar solvents（Ethanol, acetone and water mixed
Close liquid）For decentralized medium, with conventional pan coating or fluid bed as coating equipment in sugar production line it is adaptable to industrialized production.
Brief description
Fig. 1 a：Vitwas E dispersive property in water；
Fig. 1 b：Vitwas E adopts conventional microemulsion technology dispersive property in water；
Fig. 1 c：Vitwas E:VE succinic acid cetomacrogol 1000=5:2 in water dispersive property；
Fig. 1 d：Vitwas E:VE succinic acid cetomacrogol 1000=1:1 in water dispersive property；
Specific embodiment
Below by specific embodiment, technical scheme is described in further detail.
Embodiment 1：With Vitwas E：VE succinic acid cetomacrogol 1000=1:1 mixture is plasticising
Agent, plasticizer total amount is the 10% of polymer content, and polymer is Eudragit, is dissolved in pure water, adds alkali lye, mixing
Uniformly, it is made into the aqueous dispersion that polymer quality fraction is 20%.Coating device is sprayed using fluid bed bottom, in 30 ~ 50 DEG C to micropill
It is coated, coating weight gain 15%.The micropill wrapped is carried out acid resistance evaluation according to official method, after 2h, clothing film is complete, acidproof
Qualified.
Embodiment 2：With the Vitwas E of 15% polymer content as plasticizer, polymer is acrylic resin II
Number, it is dissolved in 75% ethanol solution, mixes, be made into organic coating solution that polymer quality fraction is 10%.Coating device
For high-efficiency rotating coating pan, it is coated in 40 ~ 50 DEG C, coating weight gain 8%.The tablet wrapped is carried out acid resistance according to official method
Evaluate, after 2h, clothing film is complete, acidproof qualified.
Embodiment 3：With the Vitwas E of 10% polymer content as plasticizer, polymer is acrylic resin II
Number, it is dissolved in 50% acetone soln, mixes, be made into organic coating solution that polymer quality fraction is 10%.Coating device is
High-efficiency rotating coating pan, is coated in 40 ~ 50 DEG C, coating weight gain 9.5%.The tablet wrapped is carried out acid resistance according to official method
Evaluate, after 2h, clothing film is complete, acidproof qualified.
Embodiment described above is one kind preferably scheme of the present invention, not the present invention is made any pro forma
Limit, also have other variants and remodeling on the premise of without departing from the technical scheme described in claim.
Claims (4)
1. a kind of enteric polymer clothing film, described enteric polymer clothing film be made up of plasticizer and polymer it is characterised in that：Institute
State the mixture that plasticizer is liposoluble vitamin E and watermiscible vitamin E, described polymer is Eudragit, propylene
One or more of acid resin II or Eudragit Ⅲ, the consumption of described plasticizer be total polymer mass 2～
15%, the consumption of watermiscible vitamin E accounts for the 5%～50% of plasticizer total amount, described liposoluble vitamin E be selected from vitamin E,
Vitwas E, vitamin E oleate, tocopheryl palmitate, vitamin E myristinate, vitamin E leukotrienes
Ester, vitamin E sorbate, vitamin E isostearate, a-Tocopheryl ferulate, linoleic acid ester of vitamin e, vitamin E
Any one in cellulose esters, vitamin E phosphate, vitamin E ricinoleate ester and vitamin E acrylate, water-soluble
Vitamin E is selected from any one in VE succinic acid cetomacrogol 1000, vitamin E monoglycosides and vitamin E phosphate ester salt
Kind.
2. the enteric polymer clothing film described in a kind of claim 1 preparation method it is characterised in that：Described preparation method is such as
Under：Will be soluble in water to plasticizer and polymer, plus alkali, mechanical agitation mixes, and is then coated in 30～60 DEG C, and coating weight gain is 8
～20%.
3. enteric polymer clothing film according to claim 2 preparation method it is characterised in that：The consumption of described plasticizer
Preferably account for the 2～10% of total polymer mass.
4. enteric polymer clothing film according to claim 2 preparation method it is characterised in that：Described water soluble vitamin
The consumption of E accounts for the 20%～50% of plasticizer total amount.
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| CN110372893B (en) * | 2019-07-26 | 2022-03-15 | 蓝帆医疗股份有限公司 | Butyronitrile gloves and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101045062A (en) * | 2007-02-04 | 2007-10-03 | 杨喜鸿 | Polyenephophatidylcholine enteric coated preparation, its preparing method and application |
| CN101166518A (en) * | 2005-04-26 | 2008-04-23 | 伊士曼化工公司 | Cellulosic films incorporating a pharmaceutically acceptable plasticizer with enhanced wettability |
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2014
- 2014-05-19 CN CN201410208623.8A patent/CN104107433B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101166518A (en) * | 2005-04-26 | 2008-04-23 | 伊士曼化工公司 | Cellulosic films incorporating a pharmaceutically acceptable plasticizer with enhanced wettability |
| CN101045062A (en) * | 2007-02-04 | 2007-10-03 | 杨喜鸿 | Polyenephophatidylcholine enteric coated preparation, its preparing method and application |
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Effective date of registration: 20240326 Address after: No. 425-54, Comprehensive Building, Comprehensive Bonded Zone, Lianyungang Economic and Technological Development Zone, China (Jiangsu) Pilot Free Trade Zone, Lianyungang City, Jiangsu Province, 222069 Patentee after: Jiangsu Xinyou biology Co.,Ltd. Country or region after: China Address before: Hangzhou City, Zhejiang province 310014 City Zhaohui District Six Patentee before: JIANG University OF TECHNOLOGY Country or region before: China |