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Formula of soft capsule shell

A technology of soft capsules and capsule shells, which is applied in the new technology field of soft capsule sol in the pharmaceutical industry, and can solve problems such as differences in filling volume, oil leakage, and insecure quality of soft capsules

Inactive Publication Date: 2012-05-23
贵州地道药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to provide a new formula for soft capsule shells, solve the problems of soft capsule quality insecurity, slow disintegration, seepage, and differences in loading during the stable period, overcome the shortcomings of traditional capsule shell formulas, and ensure product quality. the quality of
[0010] In order to overcome the problems of slow disintegration, oil leakage, and differences in filling volume during the soft capsule stability period

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] (1) Put in purified water: 80kg, glycerin: 30kg, sorbitol: 20kg, PEG-400: 9kg, close the feeding port, start stirring, raise the temperature of the mixed solution to 62°C, and keep the temperature of the interlayer water at 60°C during the entire sol process ℃~80℃.

[0026] (2) Slowly add 90kg of gelatin into the colloidal sol tank while stirring, and control the speed of glue injection to avoid gelatin agglomeration and affect the effect of gelatinization. After the glue feeding is completed, close the feeding port and lock it tightly, and turn on the vacuum pump to vacuumize the negative pressure sol.

[0027] (3) During the sol process, observe the conditions in the tank and the temperature and pressure changes at all times to prevent the glue from being sucked away. After the pressure reaches -0.06Mpa, turn off the vacuum pump and maintain this negative pressure for 45 minutes. Break the vacuum to observe that the gelatin has completely dissolved.

[0028] (4) Pu...

Embodiment 2

[0031] (1) Put in purified water: 80kg, glycerin: 28kg, sorbitol: 22kg, PEG-400: 10kg, close the feeding port, start stirring, raise the temperature of the mixed solution to 64°C, and keep the interlayer water temperature at 60°C during the entire sol process ℃~80℃.

[0032] (2) Slowly add 100kg of gelatin into the colloidal sol tank while stirring, and control the injection speed to avoid gelatin agglomeration and affect the gelling effect. After the glue is injected, close the feeding port and lock it tightly, and turn on the vacuum pump to vacuumize the negative pressure sol.

[0033] (3) During the sol process, observe the conditions in the tank and the temperature and pressure changes at all times to prevent the glue from being sucked away. After the pressure reaches -0.06Mpa, turn off the vacuum pump and maintain this negative pressure for 42 minutes. Break the vacuum to observe that the gelatin has completely dissolved.

[0034] (4) Put in 0.8kg of fumaric acid again...

Embodiment 3

[0037] (1) Put in purified water: 90kg, glycerin: 35kg, sorbitol: 15kg, PEG-400: 10kg, close the feeding port, start stirring, raise the temperature of the mixed solution to 60°C, and keep the interlayer water temperature at 60°C during the entire sol process ℃~80℃.

[0038] (2) Slowly add 100kg of gelatin into the colloidal sol tank while stirring, and control the injection speed to avoid gelatin agglomeration and affect the gelling effect. After the glue feeding is completed, close the feeding port and lock it tightly, and turn on the vacuum pump to vacuumize the negative pressure sol.

[0039] (3) During the sol process, observe the conditions in the tank and the changes in temperature and pressure at all times to prevent the glue from being sucked away. After the pressure reaches -0.06Mpa, turn off the vacuum pump and maintain this negative pressure for 46 minutes. Break the vacuum to observe that the gelatin has completely dissolved.

[0040] (4) Put in 1kg of fumaric ...

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Abstract

The invention relates to a formula of a soft capsule shell, which comprises gelatin, water, glycerol and sorbitol. The formula is characterized in that the proportion of a plasticizer (namely glycerol) and sorbitol is adjusted, and the components are as follows by weight percentage: gelatin 80-100%, water 60-80%, plasticizer 40-60%, antioxidant 0.2-1.2%, and PEG-400 (polyethylene glycol-400) 5-15%. Due to high requirements of soft capsules for the plasticity of shell materials, the moisturizing property of sorbitol is considered and the shell is ensured not to cause softening, deformation, adhesion, liquid leakage and other problems of the soft capsule due to excessive water content, so that the plasticizer is mixed for use to ensure the stability of the capsule. The antioxidant can prevent crosslinking due to oxidation reactions among the substances in the shell material, so as to cause time delay in disintegration of the soft capsule. The addition of the antioxidant in the formula provided by the invention can effective inhibit oxidation, so as to ensure the disintegration of the soft capsule and improve the quality of the shell material.

Description

Technical field: [0001] The invention relates to a new formula of a soft capsule shell, in particular to a new technology of soft capsule sol in the pharmaceutical industry. Background technique: [0002] Soft capsules refer to capsules in which medicinal material extracts, liquid medicines, or appropriate auxiliary materials are mixed and sealed in soft capsules by dripping or pressing. Compared with other traditional Chinese medicine forms, it has the advantages of high content of active ingredients, high bioavailability, rapid absorption, good stability, can cover the bad smell of volatile components of traditional Chinese medicine, less dosage, beautiful appearance and easy to carry, etc., so it is becoming more and more popular. By the attention of the pharmaceutical industry. The traditional capsule material formula mainly includes gelatin, water, glycerin and selected pigments. The capsule material made is made into soft capsules, and the quality is not guaranteed. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48
Inventor 路祖强
Owner 贵州地道药业有限公司
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