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Preparation method for pancreatic kininogenase enteric-coated tablets

A technology of pancreatic kininogenase and enteric-coated tablets, which is applied in the directions of medical preparations, pharmaceutical formulations, peptide/protein components containing active ingredients, etc. compliance and other issues, to achieve the effect of low cost, stable drug titer, and stable quality

Active Publication Date: 2015-12-23
CHENGDU TONGDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The Chinese patent whose publication number is CN101069742 discloses a pancreatic kininogenase tablet and a preparation method thereof. The release rate of the prepared tablet can reach more than 85%, and the purity reaches 77%, but its process design is unreasonable. During the preparation process and storage process, it is easy to cause the potency to decrease, and the content and concentration do not meet the requirements.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1: A preparation method for pancreatic kininogenase enteric-coated tablets, which comprises the following steps:

[0022] S1. Weighing: Weigh each raw material according to the following formula ratio and set aside; the formula is: 100,000 units of pancreatic kininogenase, 100 g of lactose, 20 g of starch, 3 g of sodium starch glycolate, 10 g of dextrin, 1 g of gelatin, Magnesium stearate 1g;

[0023] S2. Preparation of adhesive: adding gelatin to purified water, heating to 90°C, stirring and dissolving to a gelatin solution with a concentration of 5-10%;

[0024] S3. Preparation of wet granules: add lactose to pancreatic kininogenase for pre-diluted, put the pre-diluted pancreatic kininogenase into high-efficiency wet granulator, then add starch, dextrin and carboxypotassium starch sodium in sequence, pre-dilute Mix for 1 min, add the binder prepared in step S2 to the premixed powder, continue to stir for 3 min, add water to make wet granules with a size of 1...

Embodiment 2

[0028] Example 2: A preparation method for pancreatic kininogenase enteric-coated tablets, which comprises the following steps:

[0029] S1. Weighing: Weigh each raw material according to the following formula ratio, and set aside; the formula is: 150,000 units of pancreatic kininogenase, 130 g of lactose, 40 g of starch, 10 g of sodium starch glycolate, 20 g of dextrin, 3 g of gelatin, Magnesium stearate 5g;

[0030] S2. Preparation of adhesive: adding gelatin to purified water, heating to 110°C, stirring and dissolving to a gelatin solution with a concentration of 5-10%;

[0031] S3. Preparation of wet granules: add lactose to pancreatic kininogenase for pre-diluted, put the pre-diluted pancreatic kininogenase into high-efficiency wet granulator, then add starch, dextrin and carboxypotassium starch sodium in sequence, pre-dilute Mix for 5 minutes, add the binder prepared in step S2 to the premixed powder, continue to stir for 7 minutes, add water to make wet granules with...

Embodiment 3

[0035] Example 3: A preparation method for pancreatic kininogenase enteric-coated tablets, which comprises the following steps:

[0036] S1. Weighing: Weigh each raw material according to the following formula ratio, and set aside; the formula is: 140,000 units of pancreatic kininogenase, 125 g of lactose, 26 g of starch, 8 g of sodium starch glycolate, 12 g of dextrin, and 2.5 g of gelatin , magnesium stearate 4.2g;

[0037] S2. Preparation of adhesive: adding gelatin to purified water, heating to 100°C, stirring and dissolving to a gelatin solution with a concentration of 5-10%;

[0038] S3. Preparation of wet granules: add lactose to pancreatic kininogenase for pre-diluted, put the pre-diluted pancreatic kininogenase into high-efficiency wet granulator, then add starch, dextrin and carboxypotassium starch sodium in sequence, pre-dilute Mix for 2 minutes, add the binder prepared in step S2 to the premixed powder, continue to stir for 4 minutes, add water to make wet granu...

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Abstract

The invention discloses a preparation method for pancreatic kininogenase enteric-coated tablets. The method comprises the steps of weighing, adhesive preparing, wet granule preparing, drying, total blending and tabletting. According to the preparation method for the pancreatic kininogenase enteric-coated tablets, compatibility is achieved by adopting a reasonable formula, degradation of pancreatic kininogenase in the preparing process is avoided by controlling technological parameters in the preparing process, and therefore it is guaranteed that the drug potency and quality are stable; a unique low-temperature drying technology is adopted when drying is performed, and it can be guaranteed that the product potency is not reduced; in the tabletting process, the temperature and the humidity are strictly controlled, and therefore it is guaranteed that in the tabletting process, the product potency cannot be lost due to the fact that the product is excessively heated; the preparation method is easy to operate, low in cost and suitable for industrialized mass production.

Description

technical field [0001] The invention belongs to the field of medicine and pharmacy, and in particular relates to a preparation method of pancreatic kininogenase enteric-coated tablets. Background technique [0002] Pancreatic kininogenase is a peripheral vasodilator with the effect of dilating blood vessels and improving microcirculation. Pancreatic kininogenase acts on kininogen in the body to release kinin, which directly acts on small blood vessels and capillaries, thereby producing a A series of pharmacological effects, such as dilating capillaries, dilating small arteries, etc., can improve the permeability and blood flow of blood vessels while dilating blood vessels; it can regulate blood pressure and reduce myocardial oxygen consumption; it can also promote the secretion of prostate and improve various Organ blood flow. As an internationally recognized microcirculation improving agent, pancreatic kininogenase is an enzyme drug with definite curative effect and mild s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K38/48A61P9/12A61P9/14A61P13/12
Inventor 范伟川梁星
Owner CHENGDU TONGDE PHARMA
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