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A composition for replacing gelatin to prepare enteric capsule material and its preparation method

A material composition and enteric-coated capsule technology, applied in the field of biomedicine, can solve the problems of unstable quality of gelatin enteric-coated capsules, large quality differences within capsule batches, etc., and achieve the effects of overcoming poor performance of mixed materials and saving processes and costs.

Active Publication Date: 2016-04-20
湖南尔康明胶有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The technical problem to be solved by the present invention is to provide a composition that replaces gelatin to prepare enteric-coated capsule materials, so as to solve the problems of unstable quality of gelatin enteric-coated capsules produced in the prior art and large quality differences within capsule batches, and such The replacement can produce better technical effects than the existing gelatin enteric capsules, specifically more stable and complete release

Method used

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  • A composition for replacing gelatin to prepare enteric capsule material and its preparation method
  • A composition for replacing gelatin to prepare enteric capsule material and its preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0029] (1) Take 0.8 parts of starch and 0.4 parts of gelatin, add an appropriate amount of water to dissolve and make 1000ml of a solution with a mass concentration of 25%, add 200ml of 5% glutaraldehyde solution, stir and mix at 75°C to obtain liquid A;

[0030] (2) Take 1.1 parts of chitosan and 0.6 parts of gelatin, add an appropriate amount of 1% hydrochloric acid aqueous solution to dissolve and make 1000ml of a solution with a mass concentration of 25%, add 200ml of 5% glutaraldehyde solution, stir and mix at 70°C to obtain liquid B;

[0031] (3) Mix liquid A and liquid B, then add 0.7 parts of gelatin and 0.8 parts of ammonia water, and mix thoroughly at 70°C to obtain liquid C;

[0032] (4) Pour liquid C into a stainless steel flat tray while it is hot, spread it flat, the thickness of the liquid layer is 1-2cm, send it into a vacuum oven, and dry it at 50°C for 4 hours;

[0033] (5) After drying, take out the tray, peel off the solid inside the tray, crush and sieve t...

Embodiment 2

[0035] (1) Take 1.2 parts of starch and 0.3 parts of gelatin, add an appropriate amount of water to dissolve and make 1000ml of a solution with a mass concentration of 25%, add 3% EDC solution and stir 300ml at 75°C to obtain liquid A;

[0036] (2) Take 0.8 parts of chitosan and 0.5 parts of gelatin, add an appropriate amount of 1% hydrochloric acid aqueous solution to dissolve and make 1000ml of a solution with a mass concentration of 25%, add 200ml of 5% EDC solution, stir and mix at 70°C to obtain liquid B;

[0037] (3) Mix liquid A and liquid B, then add 0.7 parts of gelatin and 0.5 parts of potassium hydroxide, and mix thoroughly at 70°C to obtain liquid C;

[0038] (4) Pour liquid C into a stainless steel flat tray while it is hot, spread it flat, the thickness of the liquid layer is 1-2cm, send it into a vacuum oven, and dry it at 50°C for 4 hours;

[0039] (5) After drying, take out the tray, peel off the solid in the tray, crush and sieve to make

Embodiment 3

[0041] (1) Take 1 part of starch and 0.4 part of gelatin, add an appropriate amount of water to dissolve and make 1000ml of a solution with a mass concentration of 25%, add 200ml of 2% genipin solution, stir and mix at 75°C to obtain liquid A;

[0042] (2) Take 1 part of chitosan and 0.5 part of gelatin, add an appropriate amount of 1% hydrochloric acid aqueous solution to dissolve and make 1000ml of a solution with a mass concentration of 25%, add 200ml of 2% genipin solution, stir and mix at 70°C to obtain liquid B;

[0043] (3) Mix liquid A and liquid B, then add 0.8 parts of gelatin, 2% genipin solution, 0.34 parts of sodium dihydrogen phosphate, 0.36 parts of sodium monohydrogen phosphate, and mix thoroughly at 70°C to obtain liquid C;

[0044] (4) Pour liquid C into a stainless steel flat tray while it is hot, spread it flat, the thickness of the liquid layer is 1-2cm, send it into a vacuum oven, and dry it at 50°C for 4 hours;

[0045] (5) After drying, take out the tray,...

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Abstract

The invention provides a composition used as a replacement of gelatin for preparation of enteric capsule materials and a preparation method for the composition. The composition is prepared from gelatin, starch and chitosan via cross linking by a cross linking agent, and has the benefits of stronger acid resistance and solubility under a neutral-alkaline condition, namely composition has the enteric solubility; besides, with the adoption of the composition for preparing enteric capsules, enteric materials are not or rarely added.

Description

technical field [0001] The invention discloses a material composition for substituting gelatin for preparing enteric capsules and a preparation method thereof, and relates to the field of biomedicine. Background technique [0002] Enteric-coated capsules are capsules that can only be dissolved and absorbed in the human small intestine. Most of the current enteric-coated capsules are filled with special pharmaceutical polymer materials or specially treated in the shell of the capsule so that they do not dissolve in gastric juice, but only disintegrate and dissolve in intestinal juice. The "Chinese Pharmacopoeia" stipulates that in the inspection of the disintegration time limit of enteric-coated capsules, no cracks or disintegration shall occur in the hydrochloric acid solution (9→1000) without baffles for 2 hours, and the baffles shall be added in artificial intestinal juice (pH=6.8). Plate inspection, should be completely disintegrated within 1h. [0003] In the prior art...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/42C08J3/24C08L5/08C08L89/00C08L3/02C08B37/08C08H1/00C08G81/00
Inventor 帅放文王向峰章家伟
Owner 湖南尔康明胶有限公司
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