CN101708171A - Enteric plant hollow capsule - Google Patents
Enteric plant hollow capsule Download PDFInfo
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- CN101708171A CN101708171A CN200910185990A CN200910185990A CN101708171A CN 101708171 A CN101708171 A CN 101708171A CN 200910185990 A CN200910185990 A CN 200910185990A CN 200910185990 A CN200910185990 A CN 200910185990A CN 101708171 A CN101708171 A CN 101708171A
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Abstract
The invention relates to an enteric plant hollow capsule which is prepared by a method comprising: firstly adding 60-85% of pectin, 5-20% of plasticizer, 5-10% of coagulant aid and 5-10% of water used for curing agent into a reaction pot; stirring and dissolving at 60-90 DEG C, and obtaining glue stock by filtering and adjusting specific gravity; removing air bubbles and then sending into a capsule production line for the treatment such as dipping in glue, drying, cooling, demoulding, cutting, sheathing, etc. The enteric plant hollow capsule has the disintegration time limit of 3-4h in gastric juice and 30-45min in intestinal juice. Compared with the existing enteric capsule, the enteric plant hollow capsule omits the working procedure of coating, simplifies the technique, and completely uses no organic solvent, thus not only being beneficial to safe production and environmental protection, but also being beneficial to improving the efficiency and reducing the cost.
Description
One, technical field
The present invention relates to a kind of pharmaceutic adjuvant enteric hollow capsule, specifically a kind ofly do not allow disintegrate and want rapid dissolved targeting, vegetal enteric hollow capsule at the human small intestine position the human stomach.
Two, technical background
Enteric hollow capsule (softgel shell) is meant that softgel shell is insoluble in gastric juice, but can be in intestinal juice disintegrate or dissolving and discharge medicine in the capsule, softgel shell also is the main adjuvant of processing medicament capsule preparation.The enteric hollow capsule that uses is the enteric-coating material by the anti-gastric acid of outsourcing after the gelatin machine-shaping at present.Gelatin is earlier with glue after purified water immersion, the swelling, after send the capsule manufacture line through dipping in gum forming, dry solidification, obtaining gelatin Capsules capsule material, carry out enteric coating again in gelatin Capsules capsule material surface and handle back formation enteric hollow capsule capsule material, operations such as dry solidification cooling again, cutting obtain enteric hollow capsule (softgel shell).Described glue is exactly the gelatin after the swelling to be dropped into to heat up in the mixing kettle with water surface activating agent etc. stir, after filtration, remove bubble, obtain sizing material after transferring proportion.
Present enteric hollow capsule mainly is made up of the enteric-coating material and the gelatin of anti-gastric acid.The enteric-coating material of anti-gastric acid mostly is CAP or acrylic resin, and must use ethanol and acetone to make solvent when coating, and solvent evaporates in forming process is on the one hand wasted resource, raised cost, contaminated air, and is residual in addition in softgel shell on the other hand.
The water soluble protein that gelatin is obtained through hydrolysis by the collagen protein in the connective tissues such as the skin of animal, bone, tendon, ligament.Protein is subject to the influence of acid, alkali, and medicated powder acidity or alkalescence that Ruo Qinei fills are stronger, can cause hydrolysis of gelatin Capsules or sclerosis.Practice shows, in storage process, although also in the shelf-life, the quality of capsule also seriously descends, such as sclerosis, embrittlement, easy disintegrating not, serious only remaining a pile powder.In addition, because of the religions belief reason, take as taboos such as Islam, kosher; In recent years epidemic situations such as " bovine spongiform encephalopathy " of Chu Xianing, " foot and mouth disease " again serious impact gelatine enteric Capsules agent market.Other feedstock production capsules that exploitation substitutes gelatin have realistic meaning.So someone just prepares plant hollow capsule with hydroxypropyl emthylcellulose (HPMC) and polysaccharide.But this class capsule can only be at the dissolved plant hollow capsule of the stomach of human body.
Three, summary of the invention
The object of the present invention is to provide a kind of every physicochemical property to meet all that " the new enteric plant hollow capsule of Chinese pharmacopoeia regulation, technical problem to be solved is to select new capsule material and prescription thereof.
The applicant is through years of researches and exploration, and selecting with pectin is raw material, and is aided with firming agent, flocculation aid and suitable plasticizer and directly is processed into enteric plant hollow capsule, and each component has following percentage by weight:
Pectin: 60～85%,
Plasticizer: 5～20%,
Flocculation aid: 5～10%,
Firming agent: 5～10%.
Described pectin is from economic crop and garden crop side-product, and as sunflower plate, megasse, a kind of colloid macromole that obtains is extracted in processing in peel of Citrus reticulata Blanco, Fericarpium Citri Limoniae, Fructus Citri grandis skin, the Exocarpium Citrulli etc.Pectin is a kind of polymer of galacturonic acid.(hydrogen atom COOH) is methyl substituted and esterification to some carboxyl in molecule in the galacturonic acid, big or small pectin according to esterification degree is divided into low methoxyl pectin (esterification degree＜50% also claims hypo-methoxy pectin) and high-esterpectin (claiming hyper-methoxy pectin again).Experiment shows that these two kinds of pectin all can use in this application.Because pectin is taken from plant, so claim enteric plant hollow capsule.
Described plasticizer is selected from water-soluble alcohol, as sorbitol, glycerol, Polyethylene Glycol, inositol, maltose alcohol, and a kind of or both above mixed plasticizers in the polyvinyl alcohol etc.
Described flocculation aid is selected from potassium citrate or sodium citrate or potassium chloride or calcium chloride.Optimization citric acid potassium.
Described firming agent is selected from plant gum, as one or more epoxy glues in arabic gum or sesbania gum or carrageenan or gellan gum or xanthan gum or alginate jelly or the agar etc.Preferred plant glue is or/and microbiological gum, as carrageenan or/and gellan gum or/and xanthan gum etc.
Pectin, firming agent, flocculation aid and plasticizer are the key components of this enteric plant hollow capsule.In addition, the same with processing gelatin Capsules, also can add food coloring according to actual needs or/and opacifier titanium dioxide.
The preparation of this enteric plant hollow capsule also comprises the preparation of sizing material and the processing of softgel shell.Will pectin and water drop into that heated and stirred dissolving back adds firming agent, flocculation aid and plasticizer in the mixing kettle, the after-filtration that stirs, remove bubble, transfer proportion (being concentration of pectin), send capsule manufacture line processing softgel shell then.
The experiment of this enteric plant hollow capsule shows that quality index can meet " Chinese pharmacopoeia enteric hollow capsule standard fully, in gastric juice, do not dissolve, in intestinal juice, dissolve, index was as follows after testing: gastric juice 3---4 disintegration hour, 30～45 minutes disintegrations of intestinal juice, " Chinese pharmacopoeia regulation enteric hollow capsule gastric juice disintegration＞2 hour, intestinal juice disintegration＜1 hour.
This capsule is compared with existing enteric coated capsule, has saved the coating operation, work simplification, and fully not with an organic solvent, both helped safety in production, protection environment, help raising the efficiency, reducing cost.
Four, the specific embodiment
Below the present invention is described in further detail, and provide the specific embodiment.
Embodiment 1, one or more mix 6kg, purified water 60kg to get low methoxyl pectin 30kg, carrageenan or gellan gum 3kg, potassium citrate 3kg, polyvinyl alcohol, sorbitol, glycerol, Polyethylene Glycol, inositol, maltose alcohol.
Production equipment is with existing identical with the manufacturing of gelatin Capsules.Pour low methoxyl pectin and water into the reaction pot heated and stirred, dissolving, add firming agent again, flocculation aid and plasticizer, 60 ℃-90 ℃ of the recirculated water water temperatures of reaction pot, stirred 2-4 hour, fully glue is filtered with 150 purpose filter bags in the dissolving back, glue is stored in the heat-preserving container, see proportion, regulate gelatin concentration, different institutes add versicolor food coloring and add a certain amount of opacifier titanium dioxide etc. according to user's demand, leave standstill insulation again except that bubble, put into again on the capsule manufacture line through dipping in glue, oven dry, cooling, the demoulding, cutting, fit, check, packing needs lettering lettering etc. behind fit.
Embodiment 2, get high-esterpectin 30kg, carrageenan or xanthan gum 2kg, one or more mix 4kg, purified water 60kg potassium citrate 2kg, polyvinyl alcohol, sorbitol, glycerol, Polyethylene Glycol, inositol, maltose alcohol.Its production method is with embodiment 1.
Claims (6)
1. an enteric plant hollow capsule comprises pectin and adjuvant, it is characterized in that: each component has following percentage by weight:
Pectin: 60～85%,
Plasticizer: 5～20%,
Flocculation aid: 5～10%,
Firming agent: 5～10%.
2. capsule according to claim 1 is characterized in that: described plasticizer is selected from sorbitol, glycerol, Polyethylene Glycol, inositol, maltose alcohol, a kind of two or more mixed plasticizers in the polyvinyl alcohol.
3. capsule according to claim 1 is characterized in that: described flocculation aid is selected from potassium citrate or sodium citrate or potassium chloride or calcium chloride.
4. capsule according to claim 3 is characterized in that: described flocculation aid is selected from potassium citrate.
5. capsule according to claim 1 is characterized in that: described firming agent is selected from one or more epoxy glues in arabic gum or sesbania gum or carrageenan or gellan gum or xanthan gum or alginate jelly or the agar.
6. capsule according to claim 5 is characterized in that: described firming agent be selected from carrageenan or/and gellan gum or/and xanthan gum.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910185990XA CN101708171B (en) | 2009-12-17 | 2009-12-17 | Enteric plant hollow capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910185990XA CN101708171B (en) | 2009-12-17 | 2009-12-17 | Enteric plant hollow capsule |
Publications (2)
| Publication Number | Publication Date |
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| CN101708171A true CN101708171A (en) | 2010-05-19 |
| CN101708171B CN101708171B (en) | 2011-12-07 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN200910185990XA Active CN101708171B (en) | 2009-12-17 | 2009-12-17 | Enteric plant hollow capsule |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103976974A (en) * | 2014-06-11 | 2014-08-13 | 青岛双鲸药业有限公司 | Preparation method of vegetative soft capsule |
| CN104288120A (en) * | 2014-10-16 | 2015-01-21 | 绍兴康可胶囊有限公司 | Enteric-coated plant cellulose hard empty capsules and preparation method thereof |
| CN104922087A (en) * | 2015-05-29 | 2015-09-23 | 湖南尔康制药股份有限公司 | Preparation method of plant-derived enteric capsule |
| WO2016058160A1 (en) * | 2014-10-16 | 2016-04-21 | 绍兴康可胶囊有限公司 | Enteric plant cellulose hard hollow capsule and preparation method therefor |
| CN107233329A (en) * | 2017-05-12 | 2017-10-10 | 安徽黄山胶囊股份有限公司 | A kind of instant Capsules and preparation method thereof |
| 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 |
| CN111388454A (en) * | 2020-04-05 | 2020-07-10 | 刘立新 | Digestive tract regularly disintegrating capsule and its production process |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1184033A1 (en) * | 2000-09-01 | 2002-03-06 | Warner-Lambert Company | Pectin film compositions |
| CN1606978A (en) * | 2003-10-15 | 2005-04-20 | 浙江省新昌县药联胶丸有限公司 | Hollow capsule of natural plant gum and its preparing process |
| CN1947709A (en) * | 2005-10-14 | 2007-04-18 | 上海众伟生化有限公司 | Vegetative hard capsule casing material and its prodn. method |
| CN101433526B (en) * | 2007-11-13 | 2012-04-18 | 上海慧源植物胶囊股份有限公司 | Non-gelatine enteric hard capsule shell material and method for producing the same |
-
2009
- 2009-12-17 CN CN200910185990XA patent/CN101708171B/en active Active
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103976974A (en) * | 2014-06-11 | 2014-08-13 | 青岛双鲸药业有限公司 | Preparation method of vegetative soft capsule |
| CN103976974B (en) * | 2014-06-11 | 2016-03-09 | 青岛双鲸药业有限公司 | A kind of preparation method of autonomic soft capsules |
| CN104288120A (en) * | 2014-10-16 | 2015-01-21 | 绍兴康可胶囊有限公司 | Enteric-coated plant cellulose hard empty capsules and preparation method thereof |
| WO2016058160A1 (en) * | 2014-10-16 | 2016-04-21 | 绍兴康可胶囊有限公司 | Enteric plant cellulose hard hollow capsule and preparation method therefor |
| CN104922087A (en) * | 2015-05-29 | 2015-09-23 | 湖南尔康制药股份有限公司 | Preparation method of plant-derived enteric capsule |
| CN104922087B (en) * | 2015-05-29 | 2017-08-29 | 湖南尔康制药股份有限公司 | A kind of preparation method of vegetalitas capsulae enterosolubilis |
| CN107233329A (en) * | 2017-05-12 | 2017-10-10 | 安徽黄山胶囊股份有限公司 | A kind of instant Capsules and preparation method thereof |
| CN107233329B (en) * | 2017-05-12 | 2020-04-21 | 安徽黄山胶囊股份有限公司 | Instant hollow capsule and preparation method thereof |
| 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 |
| CN111388454A (en) * | 2020-04-05 | 2020-07-10 | 刘立新 | Digestive tract regularly disintegrating capsule and its production process |
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| Publication number | Publication date |
|---|---|
| CN101708171B (en) | 2011-12-07 |
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Address after: 242605 Xuancheng County, Anhui province Jingde Anhui Mount Huangshan capsule Co., Ltd. Patentee after: Anhui Huangshan Capsule Co.,Ltd. Address before: 242605 Bai Zhen, Jingde County, Anhui Province Patentee before: Anhui Huangshan Capsule Co., Ltd. |