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Enteric-coated capsule material composition

A material composition, enteric technology, applied in the field of medicine, can solve the problems of increased process and cost, poor film-forming performance, expensive, etc., to improve stretchability and stability, overcome poor performance of mixed materials, save money Process and cost effects

Active Publication Date: 2014-08-13
HUNAN ER KANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The disadvantages of the above methods are: ① In the crosslinking agent hardening method, more aldehyde crosslinking agents need to be added to achieve the purpose. There is a possibility of interaction with drugs, and there are safety problems; ②The composition of the capsule material obtained by the raw material mixing method is not uniform, the film-forming performance is not good, and the process is not easy to control. The degree of reaction of the derivatives has a great influence on the enteric properties, and the friability index of the capsule shell is difficult to meet the standard
③The enteric coating method requires additional cumbersome coating steps, which increases the process and cost
Most enteric-coated capsules currently on the market are made by this method, but due to the special properties of gelatin, this traditional coating method is difficult to achieve the desired effect, or affects the properties of the drug, or affects the stability of the overall capsule
[0014]In recent years, there have been some new technologies for preparing enteric-coated capsules, such as liquid wrapping spray sealing technology, hot-melt extrusion method, etc. Shells have a good coating effect, but these processes are either too complicated or too expensive, and it is difficult to obtain better promotion

Method used

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  • Enteric-coated capsule material composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Get 70 parts of the starch-gelatin-chitosan cross-linked compound, add 5 parts of enteric acrylic resin, 10 parts of glycerin, 0.1 part of sodium hydroxide and 10 parts of water, mix well, and make wet granules through a 24-mesh sieve. The wet granules were dried in a vacuum oven at 50°C to obtain the capsule material composition. The composition is used to prepare hollow hard capsules by adopting the existing glue-dipping method.

Embodiment 2

[0051] Take 85 parts of starch-gelatin-chitosan cross-linked compound, add 2 parts of polyethylene acetate phthalate, 3 parts of polyvinyl alcohol, 3 parts of propylene glycol, 2 parts of polyethylene glycol 200, 0.1 part of sodium hydroxide and 10 parts of water, mixed evenly, passed through a 24-mesh sieve to make wet granules, and dried in a vacuum oven at 50°C to obtain the capsule material composition. The composition is used to prepare hollow hard capsules by adopting the existing glue-dipping method.

Embodiment 3

[0053] Take 75 parts of starch-gelatin-chitosan cross-linked complex, add 15 parts of hydroxypropylmethylcellulose acetate succinate, 5 parts of triethyl citrate, 0.5 parts of potassium hydroxide and 10 parts of water, mix well, Wet granules are made through a 24-mesh sieve, and the wet granules are dried in a vacuum oven at 50° C. to obtain the capsule material composition. The composition is used to prepare hollow hard capsules by adopting the existing glue-dipping method.

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Abstract

The invention provides a novel enteric-coated capsule material composition, which is concretely composed of a starch-gelatin-chitosan crosslinking compound, an enteric material, a softening agent, a pH conditioning agent, water and a coloring agent, and water can be directly added in the composition for preparing a glue solution or sheet of the enteric-coated capsules.

Description

technical field [0001] The invention discloses an enteric capsule material composition and relates to the field of medicine. Background technique [0002] Capsules are a kind of pharmaceutical dosage form of modern medicine with a wide range of uses and varieties. Capsules can be divided into gastric-coated capsules, enteric-coated capsules, and microcapsules according to the particularity of use. Among them, stomach-dissolving capsules are the most common capsules. After oral administration, the capsules dissolve in the stomach and the drugs are released to produce medicinal effects. Microcapsules use natural or synthetic polymer materials to wrap solid drug particles or liquid drug droplets into tiny capsules with a diameter of 1-500 microns. [0003] Enteric-coated capsules are actually one of hard capsules or soft capsules, except that special medicinal polymer materials are added to the capsule shell or treated specially, so it does not dissolve in gastric juice and on...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/42A61K9/48C08J3/24C08L5/08C08L89/00C08L3/04C08L33/00C08L29/04C08L71/08C08L1/26C08B37/08C08H1/00C08B31/00
Inventor 帅放文王向峰章家伟
Owner HUNAN ER KANG PHARMA
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