CN102973534B - A kind of enteric coating liquid being suitable for tablet - Google Patents
A kind of enteric coating liquid being suitable for tablet Download PDFInfo
- Publication number
- CN102973534B CN102973534B CN201210544075.7A CN201210544075A CN102973534B CN 102973534 B CN102973534 B CN 102973534B CN 201210544075 A CN201210544075 A CN 201210544075A CN 102973534 B CN102973534 B CN 102973534B
- Authority
- CN
- China
- Prior art keywords
- enteric
- parts
- coating
- enteric coating
- coating liquid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of enteric coating liquid being suitable for tablet, calculate by weight, described enteric coating liquid is made up of 5 ~ 20 parts, coating material, plasticizer 2 ~ 12 parts, 1 ~ 5 part, surfactant and solvent 180 ~ 230 parts; Coating material is one or both in polyacrylic resin Ⅱ, polyacrylic resin Ⅲ, polyacrylic resin Ⅳ, plasticizer is one or more in diethyl phthalate, Polyethylene Glycol, Oleum Ricini, surfactant is polyoxyethylene sorbitan monoleate, and solvent is ethanol or acetone.The present invention is on the basis of existing technology, primary study has been carried out to the selection of the material of enteric coating liquid, plasticizer, surfactant and solvent and proportioning value, solve enteric coated preparation and the technical problem with release is controlled to gastrointestinal, be applicable to industrialized great production, simultaneously cost-saving, formula is simple, is applicable to the coating of all enteric coated tablets.<!--1-->
Description
Technical field
The present invention relates to a kind of enteric coating liquid being suitable for tablet, belong to field of pharmaceutical technology.
Background technology
Tablet and many granule coating are one of great achievements of the high sharp technical development of preparation in recent years; unanimously thought technical strong, difficulty large, to the of great concern technology of product quality; especially enteric coating; general textbook and handbook are except some simple introductions of principle; mostly lay particular emphasis on the introduction of outward appearance and protectiveness clothing layer, and for the data of coating quality and the introduction of experience very poor.The category that enteric coating belongs in fact " slow release dosage form ", the functional mechanism of enteric polymer is owing to dissolving under different PH and discharging medicine, but practical situation is not so simple; Some other key factor is separately had to affect the performance of enteric coating dosage form, the thickness of such as enteric coating also directly affects its emission and absorption, in general, and the increase of enteric coating consumption, the toleration of gastric acid can be increased, but the absorption problem after simultaneously medicine also being brought to enter intestinal.
Summary of the invention
The object of the invention is to, a kind of enteric coating liquid being suitable for tablet is provided, the present invention has carried out primary study to the selection of the material of enteric coating liquid, plasticizer, surfactant and solvent and proportioning value on the basis of existing technology, solve enteric coated preparation and the technical problem with release is controlled to gastrointestinal, be applicable to industrialized great production, simultaneously cost-saving, formula is simple, is applicable to the coating of all enteric coated tablets.
For solving the problems of the technologies described above, the present invention adopts following technical scheme: a kind of enteric coating liquid being suitable for tablet, calculate by weight, described enteric coating liquid is made up of 5 ~ 20 parts, coating material, plasticizer 2 ~ 12 parts, 1 ~ 5 part, surfactant and solvent 180 ~ 230 parts; Coating material is one or both in polyacrylic resin Ⅱ, polyacrylic resin Ⅲ, polyacrylic resin Ⅳ, plasticizer is one or more in diethyl phthalate, Polyethylene Glycol, Oleum Ricini, surfactant is polyoxyethylene sorbitan monoleate, and solvent is ethanol or acetone.
Aforesaidly be suitable in the enteric coating liquid of tablet, preferred coating material is polyacrylic resin Ⅱ.
Aforesaidly be suitable in the enteric coating liquid of tablet, preferred plasticizer is diethyl phthalate.
Aforesaidly be suitable in the enteric coating liquid of tablet, preferred solvent is ethanol.
Aforesaidly be suitable in the enteric coating liquid of tablet, calculate by weight, preferred enteric coating liquid is made up of polyacrylic resin Ⅱ 10 parts, diethyl phthalate 6 parts, polyoxyethylene sorbitan monoleate 2 parts and ethanol 200 parts.
Aforesaidly be suitable in the enteric coating liquid of tablet, coating solution is 1.0% ~ 2.5% to label weightening finish.
The present invention respectively with aspirin tablet, omeprazole for label, carry out enteric coating research, to its control and release study, each component of coating solution and proportioning value are screened.
1, coating mode is screened
(1) get 2 batches of aspirin tablets, bag casing again after the sealing coat of a collection of bag 2%, another batch of direct bag casing, checks its content and release.Assay, with reference to high effective liquid chromatography for measuring under " Chinese Pharmacopoeia " 2010 editions Roxithromycin items, the results are shown in Table 1.
Table 1 contagion gown is on the impact of medicament contg and release
(2) get 2 batches of Omeprazoles, bag casing again after the sealing coat of a collection of bag 2%, another batch of direct bag casing, checks its content and release.Assay, with reference to high effective liquid chromatography for measuring under " Chinese Pharmacopoeia " 2010 editions Roxithromycin items, the results are shown in Table 2.
Table 2 contagion gown is on the impact of medicament contg and release
Conclusion: from table 1,2, contagion gown does not affect the content of medicine and release, therefore selects directly enteric coated.
2, the selection of enteric-coating material
Get 3 batches of aspirin tablets, get Lac, polyacrylic resin, each 10 weight portions of enteric solubility resin again, add 6 weight portion diethyl phthalates, 2 weight portion polyoxyethylene sorbitan monoleates and 200 parts by weight of ethanol respectively, be made into three kinds of coating solutions, direct weightening finish 2% enteric coating, checks its content and release.Assay, with reference to high effective liquid chromatography for measuring under " Chinese Pharmacopoeia " 2010 editions Roxithromycin items, the results are shown in Table 3.
Table 3 contagion gown is on the impact of medicament contg and release
Result of study shows, above three kinds of enteric-coating materials, and when weightening finish 2% enteric coating liquid, release all meets the requirements.But finding in research, is coating material with Lac, be difficult in production control, coating is uneven; With enteric solubility resinae coating, its release does not have polyacrylic resin class release good, therefore selects polyacrylic resin class as enteric-coating material.
3, casing weightening finish
(1) polyacrylic resin I, II, III, No. IV each 10 weight portion are got, add 6 weight portion diethyl phthalates, 2 weight portion polyoxyethylene sorbitan monoleates and 200 weight portion 95% ethanol respectively, prepare three kinds of enteric coating solution, get aspirin label and put into BGB-10C high-efficiency coating machine bag casing, get different casing weightening finish coated tablet in coating process and do release investigation, the results are shown in Table 4.
The release check result of table 4 difference weightening finish aspirin casing sheet
(2) No. II, 10 parts by weight of polypropylene acid resin is got, add 6 weight portion diethyl phthalates, 2 weight portion polyoxyethylene sorbitan monoleates and 200 weight portion 95% ethanol preparation enteric coating solution, get omeprazole label and put into BGB-10C high-efficiency coating machine bag casing, different casing weightening finish coated tablet is got in coating process, do release to investigate, the results are shown in Table 5.
The release check result of table 5 difference weightening finish omeprazole casing sheet
From table 4,5 results: enteric coating weightening finish less than 1% time, aspirin goldbeater's skin in gastric juice can break, and does not meet the release requirement of the enteric coatel tablets of States Pharmacopoeia specifications; When enteric coating weightening finish is more than 1%, along with coating weight gain release can reduce; When reaching 3%, release can obviously reduce, so coating solution all meets States Pharmacopoeia specifications for the weightening finish of label within the scope of 1.0%-2.5%.
4, the selection of plasticizer
Get No. II, 10 parts by weight of polypropylene acid resin, get diethyl phthalate, Polyethylene Glycol, each 6 weight portions of Oleum Ricini again, add 2 weight portion polyoxyethylene sorbitan monoleates, 200 weight portion 95% ethanol respectively, prepare three kinds of enteric coating solution, get aspirin label and put into BGB-10C high-efficiency coating machine bag casing, direct weightening finish 2% enteric coating, checks its content and release, the results are shown in Table 6.
The different plasticizer of table 6 is on the impact of release
As seen from the results in Table 6: when using acrylic acid resinⅡ as coating material, enteric coating weightening finish 2%, above-mentioned three kinds of plasticizers have a certain impact to release, but all meet pharmacopoeial requirements, therefore preferably smaller diethyl phthalate is affected on release.
5, conclusion
Experimentally research shows, enteric coating key is the selection of coating solution, and selection and the proportioning value of each component of coating solution connect the weightening finish having influence on coating, and coating membrane is too thin, and casing can break in gastric juice; The blocked up release of enteric coatel tablets that can cause again of film reduces, and in intestinal juice, release reduces, and does not reach release request, affects the curative effect of medicine.And the weightening finish of coating solution also directly has influence on the quality of product, the Targeting delivery of direct relation enteric coated preparation, affects the curative effect of product.
Therefore, the present invention adopts polyacrylic resin Ⅱ 10 weight portion, diethyl phthalate 6 weight portion, polyoxyethylene sorbitan monoleate 2 weight portion and ethanol 200 weight portion to make coating solution, coating solution at 1.0%-2.5%, makes the curative effect that medicine reaches more satisfactory to label weightening finish.
Compared with prior art, the present invention has carried out primary study to the material of enteric coating liquid, plasticizer, surfactant and the selection of solvent and the selection of proportioning value on the basis of existing technology, solve enteric coated preparation and the technical problem with release is controlled to gastrointestinal, be applicable to industrialized great production, simultaneously cost-saving, formula is simple, is applicable to the coating of all enteric coated tablets, promotes release and the absorption of medicine.
Detailed description of the invention
Embodiment 1: 10 parts by weight of polypropylene acid resins II are placed in 200 parts by weight of ethanol, after polyacrylic resin Ⅱ fully dissolves, add 6 weight portion diethyl phthalates and 2 weight portion polyoxyethylene sorbitan monoleates, after stirring, obtain enteric coating liquid, this coating solution is 1.0% to label weightening finish.
Embodiment 2: 10 parts by weight of polypropylene acid resin III, 10 parts by weight of polypropylene acid resins IV are placed in 230 parts by weight of ethanol, after polyacrylic resin Ⅲ, polyacrylic resin Ⅳ fully dissolve, add 6 weight portion diethyl phthalates, 6 weight portion Oleum Ricini and 5 weight portion polyoxyethylene sorbitan monoleates, after stirring, obtain enteric coating liquid, this coating solution is 2.5% to label weightening finish.
Embodiment 3: 5 parts by weight of polypropylene acid resins III are placed in 180 pbw acetone, after polyacrylic resin Ⅲ fully dissolves, add 2 weight portion Polyethylene Glycol and 1 weight portion polyoxyethylene sorbitan monoleate, after stirring, obtain enteric coating liquid, this coating solution is 1.5% to label weightening finish.
Embodiment 4: 12 parts by weight of polypropylene acid resins II are placed in 205 parts by weight of ethanol, after polyacrylic resin Ⅱ fully dissolves, add 3 weight portion Polyethylene Glycol, 4 weight portion Oleum Ricini and 3 weight portion polyoxyethylene sorbitan monoleates, after stirring, obtain enteric coating liquid, this coating solution is 1.0% to label weightening finish.
Claims (1)
1. be suitable for an enteric coating liquid for tablet, it is characterized in that: calculate by weight, described enteric coating liquid is made up of 5 parts, coating material, plasticizer 2 parts, 1 part, surfactant and solvent 180 parts; Coating material is polyacrylic resin Ⅲ; Plasticizer is Polyethylene Glycol; Surfactant is polyoxyethylene sorbitan monoleate; Solvent is acetone; Coating solution is 1.5% to label weightening finish.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210544075.7A CN102973534B (en) | 2012-12-14 | 2012-12-14 | A kind of enteric coating liquid being suitable for tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210544075.7A CN102973534B (en) | 2012-12-14 | 2012-12-14 | A kind of enteric coating liquid being suitable for tablet |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102973534A CN102973534A (en) | 2013-03-20 |
| CN102973534B true CN102973534B (en) | 2016-03-02 |
Family
ID=47848071
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210544075.7A Active CN102973534B (en) | 2012-12-14 | 2012-12-14 | A kind of enteric coating liquid being suitable for tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102973534B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108743555B (en) * | 2018-08-03 | 2021-02-26 | 乐普恒久远药业有限公司 | Aspirin enteric-coated tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101229142A (en) * | 2007-08-14 | 2008-07-30 | 山东罗欣药业股份有限公司 | Lansoprazole enteric coated tablet and preparing method thereof |
| CN102274191A (en) * | 2011-06-10 | 2011-12-14 | 浙江丽水众益药业有限公司 | Coating liquid composition of erythromycin enteric-coated pellet |
-
2012
- 2012-12-14 CN CN201210544075.7A patent/CN102973534B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101229142A (en) * | 2007-08-14 | 2008-07-30 | 山东罗欣药业股份有限公司 | Lansoprazole enteric coated tablet and preparing method thereof |
| CN102274191A (en) * | 2011-06-10 | 2011-12-14 | 浙江丽水众益药业有限公司 | Coating liquid composition of erythromycin enteric-coated pellet |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102973534A (en) | 2013-03-20 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN104382875B (en) | A kind of pantoprazole sodium enteric tablet and preparation method thereof | |
| CN101732256A (en) | Mushroom polysaccharide chitosan nanoparticle and preparation method thereof | |
| CN102973534B (en) | A kind of enteric coating liquid being suitable for tablet | |
| CN103550188A (en) | Lansoprazole enteric-coated pellet capsule as well as preparation method thereof | |
| CN102335433B (en) | Coating membrane for micro pill tabletting and preparation method for coating membrane | |
| CN105106168A (en) | Esomeprazole magnesium enteric capsules and preparation method thereof | |
| Šalamúnová et al. | Serum and lymph pharmacokinetics of nilotinib delivered by yeast glucan particles per os | |
| CN101934079A (en) | Oral colon-specific release film coating premixed accessory of pH dependent type and preparation method thereof | |
| CN104530489B (en) | A kind of starch film-forming composition for being instantly dissolved in water | |
| CN105434398A (en) | Rabeprazole enteric-coated micro pellet, and preparation method thereof | |
| CN102526050A (en) | Stable simvastatin compound preparation and preparation method thereof | |
| CN102846577B (en) | Enteric tablet containing erythromycin cydocarbonate | |
| CN103520115A (en) | Verapamil hydrochloride sustained release microsphere and preparation method thereof | |
| CN106860406B (en) | Progestational hormone solid dispersion pellets and preparation method thereof | |
| CN102319301A (en) | Total peony glycoside osmotic pump controlled release tablet and preparation method thereof | |
| CN104473896A (en) | Rapidly-disintegrating lamivudine tablets and preparation process thereof | |
| CN105797162A (en) | Medicinal auxiliary material surface modification method | |
| CN104173292A (en) | Novel insoluble drug-loading calcium pectate nanoparticle and preparation method thereof | |
| CN109288802A (en) | A kind of preparation method of spherical shape famciclovir sustained-release capsule | |
| CN103626913A (en) | Methacrylic acid-ethyl acrylate copolymer water dispersion enteric material and preparation method thereof | |
| CN102512395A (en) | Huperzine osmotic-pump controlled release tablet | |
| CN103143025A (en) | Water-soluble enteric coating powder as well as preparation method and use method thereof | |
| CN105232481A (en) | Meloxicam dispersible tablet and preparation method thereof | |
| CN108992409A (en) | A kind of preparation method of metformin hydrochloride slow release preparation | |
| CN104546790A (en) | Lansoprazole enteric-coated capsule and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CP02 | Change in the address of a patent holder |
Address after: 550014 Luodian County, Qiannan Buyei and Miao Autonomous Prefecture, Jiefang Road Province Ping Town, No., No. 96 Patentee after: Xinbang Pharmacy Co., Ltd., Guizhou Address before: 227 No. 550014 Guizhou Guiyang Xinbang Baiyun Road Economic Development Zone Patentee before: Xinbang Pharmacy Co., Ltd., Guizhou |
|
| CP02 | Change in the address of a patent holder |