Soft capsule shell and preparation method thereof

A technology of soft capsules and gelatin capsules, which is applied in the fields of capsule transportation, pharmaceutical formulations, and medical preparations of non-effective ingredients, etc., and can solve problems such as the large impact of soft capsule disintegration, the denaturation of the soft capsule shell, and the impact on the activity of traditional Chinese medicine. Achieve the effects of improving bioavailability, slow growth, and improving stability

Active Publication Date: 2020-09-11
SHINEWAY PHARMA GRP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Most of the methods for improving the slow disintegration of soft capsules are to wrap a layer of film coating on the outside of the soft capsules, which can reduce the impact of the external environment on the soft capsules. In addition, a method of inner coating of soft capsules is also disclosed in Chinese patent CN101596174A. Provide an inner coating film that can isolate the contents from the soft capsule shell, the coating film is composed of liquid paraffin, povidone, polyacrylic acid resin II, polyvinyl alcohol 400 and citric acid, and the solvent is salad oil What this invention is to solve is that after the soft capsule in the prior art is coated with the content of traditional Chinese medicine, the activity of the active ingredients of the traditional Chinese medicine will be affected due to the reaction between the natural acid in the traditional Chinese medicine or the natural aldehyde and ketone and the soft capsule shell, and cause Problems of soft capsule shell degeneration, leakage, and local deformation
[0005] The slow disintegration of soft capsules is mainly caused by the aging caused by the cross-linking reaction of gelatin, which is the component of the capsule shell. The disintegration of soft capsules has a greater impact. During the production and use of soft capsules, part of the cross-linking reaction of gelatin is caused by the aldehydes generated by the reaction between peroxides in the soft capsules and excipients, specifically manifested as soft capsule shells. A film-like substance that can only swell but not dissolve appears on the inner wall, resulting in prolonged disintegration time

Method used

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  • Soft capsule shell and preparation method thereof
  • Soft capsule shell and preparation method thereof
  • Soft capsule shell and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Rubber prescription: 100 parts of gelatin, 40 parts of glycerin, and 130 parts of water. Mix the above materials evenly, emulsify in a glue tank at 80°C for 2 hours, degas to remove air bubbles, and transport the gelatin solution through the filter screen to the rubber box of the main machine through a pressure device to make a rubber with uniform thickness.

[0035] Coating liquid prescription: 4 parts of hydroxypropyl methylcellulose HPMC, 2 parts of glycerin, 400 parts of water. Mix the above materials evenly, and stir at 70°C for 30 minutes, take it out, keep stirring and cool to room temperature to obtain the coating solution.

[0036] Use the salivation method to evenly spread the cooled coating solution on the surface of the rubber, and perform the first drying until the water content of the rubber is 25%-30%, and the coating surface of the rubber faces the content, and use a soft capsule pellet machine The coated rubber-wrapped content is compressed into a soft...

Embodiment 2

[0038] Rubber prescription: 100 parts of gelatin, 40 parts of glycerin, and 130 parts of water. Mix the above materials evenly, emulsify in a glue tank at 80°C for 2 hours, degas to remove air bubbles, and transport the gelatin solution through the filter screen to the rubber box of the main machine through a pressure device to make a rubber with uniform thickness.

[0039] Coating solution prescription: 6 parts of hydroxypropyl methylcellulose HPMC, 3 parts of glycerin, and 400 parts of water. Mix the above materials evenly, and stir at 70°C for 30 minutes, take it out, keep stirring and cool to room temperature to obtain the coating solution.

[0040] Use the salivation method to evenly spread the cooled coating solution on the surface of the rubber, and perform the first drying until the water content of the rubber is 25%-30%, and the coating surface of the rubber faces the content, and use a soft capsule pellet machine The coated rubber-wrapped content is compressed into ...

Embodiment 3

[0042]Rubber prescription: 100 parts of gelatin, 40 parts of glycerin, and 130 parts of water. Mix the above materials evenly, emulsify in a glue tank at 80°C for 2 hours, degas to remove air bubbles, and transport the gelatin solution through the filter screen to the rubber box of the main machine through a pressure device to make a rubber with uniform thickness.

[0043] Coating solution prescription: 8 parts of hydroxypropyl methylcellulose HPMC, 4 parts of glycerin, and 400 parts of water. Mix the above materials evenly, and stir at 70°C for 30 minutes, take it out, keep stirring and cool to room temperature to obtain the coating solution.

[0044] Use the salivation method to evenly spread the cooled coating solution on the surface of the rubber, and perform the first drying until the water content of the rubber is 25%-30%, and the coating surface of the rubber faces the content, and use a soft capsule pellet machine The coated rubber-wrapped content is compressed into a...

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Abstract

The invention relates to the technical field of soft capsules, in particular to a soft capsule shell and a preparation method thereof. A layer of film coat is arranged between a gelatin capsule shelland contents of a soft capsule, and the film coat consists of hydroxypropyl methyl cellulose HPMC, glycerin and water. According to the soft capsule provided by the invention, the film coat is coatedin the soft capsule, so that the capsule shell is avoided from being in direct contact with the contents, low molecule aldehydes in the soft capsule can be prevented from generating a crosslinking reaction with the gelatin capsule shell, an aging phenomenon of the capsule shell is relieved, and the stability of the soft capsule is increased. The soft capsule shell can effectively reduce the generation probability that the low molecule aldehydes have the crosslinking reaction with the gelatin capsule shell, the disintegration time increase of the obtained coated soft capsule is slow, and the biological availability of the soft capsule is effectively increased.

Description

technical field [0001] The invention relates to the technical field of soft capsules, in particular to a soft capsule shell and a preparation method thereof. Background technique [0002] Soft capsules refer to directly encapsulating a certain amount of liquid raw materials, or dissolving or dispersing solid raw materials in suitable excipients to prepare solutions, suspensions, emulsions or semi-solids, and sealing them in spherical or oval soft capsules. The capsule in the capsule material is composed of two parts, the content and the capsule material. The content is mostly oil-based, and the capsule material is mostly gelatin. However, gelatin is prone to cross-linking reactions and changes the solubility of the capsule shell. Eventually cause the soft capsule to disintegrate slowly, have a strong impact on the quality of the soft capsule product. [0003] In order to solve the problem of slow aging and disintegration caused by soft capsules, some researchers have develo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/38A61K47/10A61K47/42
CPCA61K9/4825A61K9/4816A61K9/4891A61K47/38A61K47/10
Inventor 张纯刚程岚付慧敏
Owner SHINEWAY PHARMA GRP LTD
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