Method for preparing Tiopronin enteric-coated tablet

A technology of tiopronin sausage and tiopronin tablets, which is applied in the field of raw materials, can solve problems such as inconspicuousness, patient resistance, unfavorable patient medication, etc., and achieves the reduction of specific odor, slight particle taste, and simple process Effect

Active Publication Date: 2009-12-02
ベイジンカインバイオテックシーオーエルティーディー +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to its strong specific odor, most of the currently available products on the market cannot effectively cover up its odor, causing patients to have resistance to taking the drug, which is not conducive to the patient's medication
The method of increasing the thickness of the enteric-coated coating has a certain effect on masking the specific odor, but it is not obvious. At the same time, the dissolution of the enteric-coated tablet is slow, and the quality of the drug cannot be guaranteed.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1 Preparation of tiopronin enteric-coated tablets

[0020] 1. Weigh 100 grams of tiopronin, 100 grams of starch, and 40 grams of microcrystalline cellulose, mix and pulverize, bond with 10% starch slurry, granulate with a 20-mesh sieve, dry with air at 50°C for 4 hours, and granulate with a 18-mesh sieve , add 2 grams of magnesium stearate, mix well, and compress into tablets to prepare tiopronin tablets;

[0021] 2. The water-soluble film-coating coating powder is formulated into a coating powder solution, and the plain tablet is coated with a film coating as an isolation layer, and the weight gain of the coating is 2.1%;

[0022] 3. The enteric coating coating powder is prepared into an enteric coating powder solution, and the product of the previous step is coated with an enteric coating, and the weight gain of the coating is 10.3%. Tiopronin enteric-coated tablets were prepared. Aluminum-plastic blister packaging, that is, the finished product.

Embodiment 2

[0023] Example 2 Preparation of tiopronin enteric-coated tablets

[0024] 1. Weigh 100 grams of tiopronin, 80 grams of starch, and 60 grams of microcrystalline cellulose, mix and pulverize, bond with 10% starch slurry, granulate with a 20-mesh sieve, dry with air at 50°C for 4 hours, and granulate with a 18-mesh sieve , add 1 gram of magnesium stearate, mix evenly, and compress into tablets to prepare tiopronin tablets;

[0025] 2. The water-soluble film-coating powder is formulated into a coating powder solution, and the plain tablet is coated with a film as an isolation layer. Coating weight gain 1.8%;

[0026] 3. The enteric-coating powder is prepared into an enteric-coating powder solution, and the product of the previous step is coated with an enteric-coating, and the weight gain of the coating is 12.1%. Tiopronin enteric-coated tablets were prepared. Aluminum-plastic blister packaging, that is, the finished product.

Embodiment 3

[0027] Example 3 Detection

[0028] Get the sample that embodiment 1 and embodiment 2 make detect, all no longer have the specific odor of raw material. According to the dissolution test, the above-mentioned samples had no change in tablet appearance in 0.1M hydrochloric acid solution for 2 hours, and the dissolution rates in pH 6.8 phosphate solution were 98.3% and 99.2% respectively after 45 minutes. Therefore, the tiopronin enteric-coated tablets prepared by the method of the present invention can effectively cover the specific odor of raw materials, and the dissolution meets the relevant national requirements.

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PUM

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Abstract

The invention provides a method for preparing Tiopronin enteric-coated tablet. The method comprises the steps of preparing Tiopronin tablet, tablet wrapping isolation clothes, wrapping enteric coating and the like. The Tiopronin enteric-coated tablet produced according to the method of the invention features simple technique and low cost, and can effectively cover the odor of Tiopronin.

Description

technical field [0001] The invention relates to the field of crude drugs, in particular to a preparation method of tiopronin enteric-coated tablets. Background technique [0002] Tiopronin is a glycine derivative created by Japan in 1963. It has low toxic and side effects and can be used for the treatment of chronic hepatitis and liver cirrhosis. It has been approved for use in Japan, Italy and other countries. [0003] Tiopronin is hydrolyzed by amidase in the body to generate glycine, which is mainly involved in the synthesis of purine nucleic acids, so it has the effect of promoting liver cell regeneration. It can activate superoxide dismutase and increase the detoxification function of the liver. Tiopronin can also promote the excretion of heavy metals and their poisons, and has important detoxification and liver protection effects. At present, it has been widely used clinically in the early treatment of viral hepatitis, alcoholic hepatitis, drug-induced hepatitis, hea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/195A61P1/16A61P31/12
Inventor 张春丽周德胜吉春
Owner ベイジンカインバイオテックシーオーエルティーディー
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