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A kind of enzymatic granulation method suitable for compound azinamide enteric-coated tablets

A compound azinamide enteric and tablet-dissolving technology, applied in the field of medicine, can solve problems such as being unsuitable for heat-sensitive raw materials, and achieve the effects of good enzymatic activity retention ability, high particle yield and strong compressibility

Active Publication Date: 2019-11-12
YANGZHOU YIYANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commonly used granulation techniques include wet granulation, boiling granulation, etc. This type of granulation inevitably includes heating steps, which are not suitable for heat-sensitive raw materials.

Method used

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  • A kind of enzymatic granulation method suitable for compound azinamide enteric-coated tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Preparation of Enzyme Granules

[0051] (1) The mass ratio of each raw material is: trypsin: cellulase 4000: simethicone: magnesium aluminum silicate: micropowder silica gel = 30:3:1:30:80;

[0052] (2) Preparation process: Take magnesium aluminum silicate and micro-powder silica gel, mix well, add simethicone, mix well, add pancreatin and cellulase 4000, mix well, put into dry granulator, use rolling method For granulation, the roller pressure is 2.0 MPa, the roller speed is 15 revolutions / min, and the granules are sized to obtain the product.

[0053] Technical Indicator Test

[0054]The test method refers to test examples 1 and 2, and the results are shown in the table below. The results show that the enzyme granules prepared in this embodiment have a high yield and stable enzyme activity.

[0055] Table 3 Enzyme granulation technical index test

[0056] group Yield (%) Cellulase 4000 activity This example 83.6 25.1

Embodiment 2

[0058] Preparation of Enzyme Granules

[0059] (1) The mass ratio of each raw material is: trypsin: cellulase 4000: simethicone: magnesium aluminum silicate: micropowder silica gel = 30:3:1:40:100;

[0060] (2) Preparation process: Take magnesium aluminum silicate and micro-powder silica gel, mix well, add simethicone, mix well, add pancreatin and cellulase 4000, mix well, put into dry granulator, use rolling method For granulation, the roller pressure is 3.0 MPa, the roller speed is 25 revolutions / min, and the granules are sized.

[0061] Technical Indicator Test

[0062] The test method refers to test examples 1 and 2, and the results are shown in the table below. The results show that the enzyme granules prepared in this embodiment have a high yield and stable enzyme activity.

[0063] Table 4 Enzyme granulation technical index test

[0064] group Yield (%) Cellulase 4000 activity This example 81.5 25.7

Embodiment 3

[0066] Preparation of Enzyme Granules

[0067] (1) The mass ratio of each raw material is: trypsin: cellulase 4000: simethicone: magnesium aluminum silicate: micropowder silica gel = 30:3:1:35:90;

[0068] (2) Preparation process: Take magnesium aluminum silicate and micro-powder silica gel, mix well, add simethicone, mix well, add pancreatin and cellulase 4000, mix well, put into dry granulator, use rolling method For granulation, the roller pressure is 2.5MPa, the roller speed is 20 rpm, and the granules are sized to obtain the product.

[0069] Technical Indicator Test

[0070] See test examples 1 and 2 for test results.

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Abstract

The invention relates to an enzyme granulation method for compound azimtamide entieric-coated tablets. The method comprises steps as follows: (1) the mass ratio of raw materials, namely, the mass ratio of pancreatin to cellulase 4000 to dimethicone to aluminum--magnesium silicate to aerosol is 30:3:1:(30-40):(80-100); (2) the preparation process comprises steps as follows: aluminum-magnesium silicate and aerosol are taken and mixed uniformly, dimethicone is added, the mixture is mixed uniformly, pancreatin and cellulase 4000 are added, the mixture is mixed uniformly and put into a dry type granulator, granulation and size stabilization are performed with a rolling method, and granules are obtained. According to the method, granules containing pancreatin and cellulase 4000 are prepared, operation is simple and convenient, the yield of the prepared granules is high, grain size distribution is centralized, the friability is good, and the enzyme activity is seldom reduced.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a preparation method of compound azinamide enteric-coated tablets. Background technique [0002] Compound Azimtamide Enteric-coated Tablets (Compound Azimtamide Enteric-coated Tablets) is a drug approved for marketing in the People's Republic of China, mainly used for symptoms caused by insufficient bile secretion or lack of digestive enzymes. Compound azinamide enteric-coated tablets are in accordance with the National Drug Standard WS of the Food and Drug Administration of the People's Republic of China 1 -(X-346)-2004Z-2010 for quality control. [0003] Each compound azinamide enteric-coated tablet contains the following active ingredients: azinamide 75mg, pancreatin 100mg, cellulase 4000 100mg, dipotassium silicone oil 50mg. Among them, azinamide is a drug that promotes bile secretion, which can increase the liquid volume of bile and increase the secretion of solid compon...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/47A61K9/20A61K9/16A61P1/16A61P1/00A61K38/43A61K31/50A61K31/80
CPCA61K9/1682A61K9/2009A61K31/50A61K31/80A61K38/43A61K38/47C12Y302/01004A61K2300/00
Inventor 吉宏王亚斌徐锦升
Owner YANGZHOU YIYANG PHARMA