CN102552209A - Double-layer hollow capsule and multi-layer enteric hollow capsule - Google Patents
Double-layer hollow capsule and multi-layer enteric hollow capsule Download PDFInfo
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- CN102552209A CN102552209A CN2012100027039A CN201210002703A CN102552209A CN 102552209 A CN102552209 A CN 102552209A CN 2012100027039 A CN2012100027039 A CN 2012100027039A CN 201210002703 A CN201210002703 A CN 201210002703A CN 102552209 A CN102552209 A CN 102552209A
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Abstract
A double-layer hollow capsule comprises a gelatine layer and is characterized in that a stomach soluble hollow capsule formed by an isolation layer made of stomach soluble membrane forming materials is arranged on the inner wall of the gelatine layer. A multi-layer enteric hollow capsule comprises a gelatine layer and is characterized in that an enteric hollow capsule formed by an isolation layer made of enteric membrane forming materials is arranged on the inner wall of the gelatine layer. The isolation layers can be resistant to acidity and alkalinity of medicines to protect the gelatine layers and ensure that the capsules do not deteriorate during storage periods.
Description
One, technical field
The present invention relates to a kind of special pharmaceutic adjuvant Capsules and enteric hollow capsule, specifically a kind of double-layer hollow capsule and multiple enteric Capsules.
Two, background technology
Capsules in the market and enteric hollow capsule; Its production technology: glue after gelatin elder generation water logging bubble, the swelling; Demand versicolor food coloring that difference adds according to the user; With add a certain amount of opacifier titanium dioxide etc., after send the capsule manufacture line through dipping in gum forming, dry solidification and obtain or dissolving and discharge the Capsules of medicine in the capsule in the stomach disintegrate; To enteric hollow capsule is the enteric-coating material of the anti-gastric acid of outsourcing one deck on the basis of above-mentioned Capsules, and it is insoluble to gastric juice, but can be in intestinal juice disintegrate or dissolve and discharge medicine in the capsule.
Gelatin is a kind of protein, and the medicated powder of capsule its content between the storage life can make the protein denaturation sclerosis not dissolve if having alkalescence, if having acidity, then protein meeting degeneration hydrolysis finally all will influence capsular quality.Solution to this problem is to be filled in corresponding Capsules (softgel shell) or the enteric hollow capsule (softgel shell) after the medicated powder with acidity or alkalescence is processed into micropill or enteric coated micropill again at present, separates through the outer film that coats of micropill and the inwall of softgel shell.The omeprazole enteric-coated capsules of the treatment gastropathy of selling like existing market is processed enteric coated micropill to medicated powder exactly and is filled in the Capsules.So-called micropill is exactly to wrap gastric solubleness film that cuts off the infiltration of medicated powder Acidity of Aikalinity and the enteric film that needs at the dissolved anti-gastric acid of intestinal portion at particle surface again after processing granule to medicated powder.If coat incomplete or bottom pour ladle, will cause micropill defective.This shows that the processing micropill has not only increased production cost, also is difficult to ensure the quality of products simultaneously.
Three, summary of the invention
The present invention is intended to meet for the medicine with acidity or alkalescence provides a kind of each item physicochemical property that " double-layer hollow capsule and the multiple enteric Capsules of Chinese pharmacopoeia regulation, technical problem to be solved are to have the directly fill and need not to process micropill or enteric coated micropill of acidity or alkaline medicine.
Thinking of the present invention is on the inwall of gelatin softgel shell, to adhere to one deck sealing coat, influences the quality of capsule thereby the medicine of avoiding having acidity or alkalescence directly contacts with gelatin.This just means that this softgel shell has the sealing coat double-decker of gelatin shell and Qi Nei.
This double-layer hollow capsule comprises gelatin layer; Difference with the prior art is the sealing coat that gastric solubility is arranged on the inwall of gelatin layer, and described sealing coat is selected from one or more composite materials in hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, methylcellulose, POLY-karaya, xanthan gum, pulullan polysaccharide or the Polyethylene Glycol in the gastric solubleness filmogen.The erosion of above-mentioned material ability pharmaceutical acid alkalescence.
The capsular processing method of this double-layer hollow is that the gastric solubleness filmogen is processed the gastric solubleness glue with purified water as solvent earlier; Dip in glue with capsule die then; Treat then to dip in the gelatin glue again after the glue film forming drying, be the double-layer hollow capsule of gastric solubility sealing coat outsourcing gelatin in obtaining after the dry solidification demoulding.Technical process is identical with processing gelatin Capsules with equipment.
This multiple enteric Capsules comprises gelatin layer; Difference with the prior art is the sealing coat that enteric solubility is arranged on the inwall of gelatin layer at least, and described sealing coat is selected from one or more composite materials in cellacefate, methacrylic acid and ethyl acrylate copolymer, phthalic acid hydroxypropyl cellulose ester, hydroxypropyl emthylcellulose acetate succinate, zein, Lac or the sodium alginate etc. in the enteric filmogen.The erosion that not only anti-gastric acid of above-mentioned enteric filmogen but also drug resistance are sour, alkaline.
Gelatin is the meeting disintegrate in gastric juice, for guaranteeing the enteric coated capsule quality of stability, coating enteric layer on the outer wall of gelatin layer, three layers of enteric hollow capsule of sealing coat of formation enteric coat layer, gelatin layer and Qi Nei, title multiple enteric Capsules.Coatings and sealing coat have enteric properties.
The processing method of this multiple enteric Capsules is that the enteric filmogen is earlier processed the enteric glue with ethanol and acetone or purified water as solvent; Dip in epigaster sol solutions film forming with capsule die then; Treat then to dip in the gelatin glue again after the film drying; Wrap one deck enteric coating behind the dry solidification again, be the enteric solubility sealing coat outsourcing gelatin of anti-gastric acid in obtaining after the demoulding, on gelatin, also have the multiple enteric Capsules of one deck enteric coating again.
The water soluble protein that described gelatin is obtained through hydrolysis by the collagen protein in the connective tissues such as the skin of animal, bone, tendon, ligament.It is the primary raw material of processing Capsules.Surfactant is a sodium lauryl sulphate, and opacifier is a white titanium pigment.Gelatin, gastric solubleness filmogen, enteric filmogen are the key components of this double-layer hollow capsule and multiple enteric Capsules; In addition; The same with the processing Capsules, also can add food coloring, opacifier titanium dioxide and surfactant etc. according to actual needs.The gelatin glue is to drop into to heat up in the mixing kettle with surface-active agent etc. with gelatin, water to stir, through filtering, add pigment, add opacifier, remove bubble, obtaining sizing material behind the accent proportion.Send the capsule manufacture line to be processed into Capsules then.The Capsules of double-layer hollow capsule and multiple enteric Capsules and domestic production at present and enteric hollow capsule filling medicated powder are processed micropill (comprising gastric solubleness micropill and enteric coated micropill) and are compared its advantage and be:
1, operation is few: pharmaceutical factory uses double-layer hollow capsule and multiple enteric Capsules production process to reduce.Can be directly pack medicated powder in bilayer or the multilamellar capsule into, need not process granule to medicated powder and wrap gastric solubleness film that cuts off the infiltration of medicated powder Acidity of Aikalinity and the enteric-coating material that needs at the dissolved anti-gastric acid of intestinal portion at particle surface again.
2, cost is low: pharmaceutical industry does not need to build the workshop of processing medicated powder micropill again, and small investment, cycle weak point, minimizing system micropill need defectives such as energy consumption height like this.All will wrap the micropill of not count enable the enteric-coating material of gastric solubleness film and anti-gastric acid in addition, the material of consumption is many.And directly dip in gastric solubleness glue and enteric glue with capsule die, can save raw material and economize a lot.
3, the product quality qualification rate is high: the gastric solubleness glue dips in capsule die and the enteric glue dips in film forming with capsule die, and technology is simple, does not exist to omit and problem of non-uniform.
4, plasticiser content is low: employed gastric solubleness film of bilayer and multilamellar Capsules internal layer and anti-gastric acid enteric film; Because of being dips in scribbling on the capsule die of releasing agent after the drying and can very easily pull up from mould; And film is dipped in the gelatin glue, and viscous force is very strong, is that stripping be unable to do without; Therefore be need not add any plasticiser but can ensure the quality of products in the film, and process the contained plasticiser content of micropill high (effect of plasticiser plays bating effect to film exactly) to medicated powder.Otherwise cracking appears in micropill easily, causes micropill defective, and the product patient of plasticizer-containing takes health also harmful for a long time;
5, drug absorption is good, and curative effect is high: process micropill to medicated powder and be filled in the Capsules with medicated powder again and directly be filled in the Capsules, the content of medicated powder is different; Directly be filled in the Capsules medicated powder; Medicated powder content is high, good effect, and the patient avoids taking and other irrelevant adjuvant of medicine.
6,, thereby guarantee that capsule never degenerates in the storage life because gelatin layer receives the protection of sealing coat.
Four, the specific embodiment
Below the present invention is described in further detail, and provide the specific embodiment.
Embodiment 1, from gastric solubleness filmogen series of products, filter out one or more blended gastric solubleness filmogens such as hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, methylcellulose, POLY-karaya, xanthan gum, pulullan polysaccharide, Polyethylene Glycol; Process the gastric solubleness glue of 30% concentration as solvent with purified water; The glue film forming is dipped in capsule die in the back; Treat then to dip in the gelatin glue again after film is done, gelatin 30kg, purified water 120kg are got in the preparation of gelatin glue.Pour gelatin and water into reaction pot heated and stirred, dissolving; 60-90 ℃ of the recirculated water water temperature of reaction pot stirred 2-4 hour, after fully dissolving, stirring; Filter glue with 200 purpose filter bags; Glue is stored in the heat-preserving container, sees proportion, regulates gelatin concentration; Different required versicolor food coloring and/or a certain amount of opacifier titanium dioxide etc. of adding of demand according to the user; Leave standstill insulation and remove bubble again, putting on the fully-automatic capsule production line the capsule die of wrapping the gastric juice film is that gastric solubleness film sealing coat, skin are the double-layer hollow capsule of gelatin through dipping in glue, oven dry, (cooling, the demoulding, cutting, fit) disposable automatic moulding in machine, processing special internal layer more again.
Embodiment 2, from the enteric filmogen series of products of anti-gastric acid, filter out cellacefate, methacrylic acid and ethyl acrylate copolymer, phthalic acid hydroxypropyl cellulose ester, hydroxypropyl emthylcellulose acetate succinate, Yu Mi ?, one or more mix and dip in epigaster sol solutions film forming with capsule die after processing enteric glue body with ethanol and acetone or purified water as solvent for raw material for Lac, sodium alginate etc.; Treat then to dip in the gelatin glue again after film is done; The gelatin glue is wrapped the enteric glue again after doing again; Its production method of gelatin glue preparation is with embodiment 1; Obtaining internal layer after the dry solidification demoulding is the enteric film sealing coat outsourcing gelatin of anti-gastric acid, wraps the multiple enteric Capsules of enteric coating again.
Claims (3)
1. double-layer hollow capsule; Comprise gelatin layer; It is characterized in that: the sealing coat of gastric solubility is arranged on the inwall of gelatin layer, and described sealing coat is selected from one or more the blended gastric solubleness filmogens in hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, methylcellulose, POLY-karaya, xanthan gum, pulullan polysaccharide or the Polyethylene Glycol.
2. multiple enteric Capsules; Comprise gelatin layer; It is characterized in that: the sealing coat of enteric solubility is arranged on the inwall of gelatin layer at least, and described sealing coat is selected from one or more enteric filmogens in cellacefate, methacrylic acid and ethyl acrylate copolymer, phthalic acid hydroxypropyl cellulose ester, hydroxypropyl emthylcellulose acetate succinate, zein, Lac or the sodium alginate.
3. multiple enteric Capsules according to claim 2 is characterized in that: coating has enteric coat layer on the outer wall of gelatin layer.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012100027039A CN102552209A (en) | 2012-01-06 | 2012-01-06 | Double-layer hollow capsule and multi-layer enteric hollow capsule |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012100027039A CN102552209A (en) | 2012-01-06 | 2012-01-06 | Double-layer hollow capsule and multi-layer enteric hollow capsule |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104905967A (en) * | 2015-05-23 | 2015-09-16 | 浙江益立胶囊股份有限公司 | Production mold for double-layer enteric hollow capsule |
| CN108042506A (en) * | 2018-01-09 | 2018-05-18 | 上海祺宇生物科技有限公司 | A kind of enteric plant capsule and its capsule |
| CN108159014A (en) * | 2018-01-09 | 2018-06-15 | 上海祺宇生物科技有限公司 | A kind of enteric plant capsule |
| CN109602718A (en) * | 2018-12-24 | 2019-04-12 | 江苏辰星药业股份有限公司 | A kind of enteric plant soft capsule and preparation method thereof |
| CN111990674A (en) * | 2020-01-14 | 2020-11-27 | 青岛圣邦健康食品有限公司 | Enteric coating material, preparation method thereof and enteric product |
| CN112641751A (en) * | 2020-09-25 | 2021-04-13 | 广州启键生物科技有限公司 | Filling hollow capsule of hydroxypropyl methylcellulose and algal polysaccharide |
| CN112999326A (en) * | 2019-12-19 | 2021-06-22 | 广州白云山陈李济药厂有限公司 | Spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill and preparation method thereof |
| CN114306273A (en) * | 2022-01-11 | 2022-04-12 | 新昌辽远科技有限公司 | Multilayer hollow capsule and preparation method thereof |
| CN117159506A (en) * | 2023-11-02 | 2023-12-05 | 江苏海王健康生物科技有限公司 | Enteric plant capsule, preparation process and application |
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| JPH01117826A (en) * | 1987-10-30 | 1989-05-10 | Nisshin Flour Milling Co Ltd | Production of enteric capsule |
| WO1996040083A2 (en) * | 1995-06-07 | 1996-12-19 | R.P. Scherer Corporation | Methods and compositions for preparing soft gelatin capsules having shells resistant to permeation by fill materials |
| WO2008119943A2 (en) * | 2007-03-29 | 2008-10-09 | Aston University | Enteric pharmaceutical capsules |
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- 2012-01-06 CN CN2012100027039A patent/CN102552209A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01117826A (en) * | 1987-10-30 | 1989-05-10 | Nisshin Flour Milling Co Ltd | Production of enteric capsule |
| WO1996040083A2 (en) * | 1995-06-07 | 1996-12-19 | R.P. Scherer Corporation | Methods and compositions for preparing soft gelatin capsules having shells resistant to permeation by fill materials |
| WO2008119943A2 (en) * | 2007-03-29 | 2008-10-09 | Aston University | Enteric pharmaceutical capsules |
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104905967B (en) * | 2015-05-23 | 2019-04-16 | 浙江益立胶囊股份有限公司 | Production mould for the double-deck enteric hollow capsule |
| CN104905967A (en) * | 2015-05-23 | 2015-09-16 | 浙江益立胶囊股份有限公司 | Production mold for double-layer enteric hollow capsule |
| CN108042506A (en) * | 2018-01-09 | 2018-05-18 | 上海祺宇生物科技有限公司 | A kind of enteric plant capsule and its capsule |
| CN108159014A (en) * | 2018-01-09 | 2018-06-15 | 上海祺宇生物科技有限公司 | A kind of enteric plant capsule |
| CN109602718A (en) * | 2018-12-24 | 2019-04-12 | 江苏辰星药业股份有限公司 | A kind of enteric plant soft capsule and preparation method thereof |
| CN112999326B (en) * | 2019-12-19 | 2022-04-29 | 广州白云山陈李济药厂有限公司 | Spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill and preparation method thereof |
| CN112999326A (en) * | 2019-12-19 | 2021-06-22 | 广州白云山陈李济药厂有限公司 | Spleen-tonifying intestine-benefiting gastrointestinal dissolution type pill and preparation method thereof |
| CN111990674A (en) * | 2020-01-14 | 2020-11-27 | 青岛圣邦健康食品有限公司 | Enteric coating material, preparation method thereof and enteric product |
| CN111990674B (en) * | 2020-01-14 | 2021-07-02 | 青岛圣邦健康食品有限公司 | Enteric coating material, preparation method thereof and enteric product |
| CN112641751A (en) * | 2020-09-25 | 2021-04-13 | 广州启键生物科技有限公司 | Filling hollow capsule of hydroxypropyl methylcellulose and algal polysaccharide |
| CN114306273A (en) * | 2022-01-11 | 2022-04-12 | 新昌辽远科技有限公司 | Multilayer hollow capsule and preparation method thereof |
| CN117159506A (en) * | 2023-11-02 | 2023-12-05 | 江苏海王健康生物科技有限公司 | Enteric plant capsule, preparation process and application |
| CN117159506B (en) * | 2023-11-02 | 2024-02-13 | 江苏海王健康生物科技有限公司 | Enteric plant capsule, preparation process and application |
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Application publication date: 20120711 |