Preparation method of tiopronin tablets

A technology of tiopronin tablets and tiopronin, which is applied in the direction of pill delivery, digestive system, peptide/protein components, etc., can solve the problems of unsuitable tiopronin tablets, achieve good drug stability, prevent damp heat damage, The effect of low production cost

Inactive Publication Date: 2014-04-09
YICHANG HEC CHANGJIANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to provide a preparation method of tiopronin tablets, which can solve the problem that the traditional wet granulation process (using wet granulation after mixing the main drug and auxiliary drug) is not suitable for the production of tiopronin tablets, It can avoid tiopronin from being damaged by heat and humidity in the production process, and the operation is simple and the cost is low

Method used

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  • Preparation method of tiopronin tablets
  • Preparation method of tiopronin tablets
  • Preparation method of tiopronin tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] A preparation method of tiopronin tablet, the method is made up of the following steps:

[0020] 1) Excipient granulation: Put pregelatinized starch, microcrystalline cellulose, lactose and crospovidone into the wet mixing granulator, add binder (PVP-K30 with a mass concentration of 5% aqueous solution), granulation;

[0021] 2) Dry the wet granules prepared in step 1) at 70°C, collect the granules when the moisture content of the granules reaches 1-3%, and sizing the granules with a fast granulator;

[0022] 3) Add tiopronin raw material and additional auxiliary materials (silicon dioxide, talc and magnesium stearate), and mix;

[0023] 4) Determining the content of tiopronin in the mixed granules; compressing the mixed granules with qualified content into tablets to make tiopronin plain tablets.

[0024] 5) Coating the prepared tiopronin tablets to make tiopronin sugar-coated tablets.

[0025] Take the prepared tiopronin tablet sample, place it in a stability test ...

Embodiment 2

[0030] A preparation method of tiopronin tablet, the method is made up of the following steps:

[0031] 1) Excipient granulation: Put pregelatinized starch, microcrystalline cellulose, mannitol and croscarmellose sodium into the wet mixing granulator, add binder (mass concentration of 8% PVP-K30 aqueous solution), granulation;

[0032] 2) Dry the wet granules prepared in step 1) at 60°C, collect the granules when the moisture content of the granules reaches 1-3%, and sizing the granules with a fast granulator;

[0033] 3) Add tiopronin raw material and additional excipients (silicon dioxide and magnesium stearate), and mix;

[0034] 4) Determining the content of tiopronin in the mixed granules; compressing the mixed granules with qualified content into tablets to make tiopronin plain tablets;

[0035] 5) Coating the prepared tiopronin tablets with enteric coating powder solution to make tiopronin enteric-coated tablets.

[0036] Take the prepared tiopronin tablet sample, pl...

Embodiment 3

[0040] A preparation method of tiopronin tablet, the method is made up of the following steps:

[0041] 1) Excipient granulation: Put calcium hydrogen phosphate, microcrystalline cellulose, lactose and croscarmellose sodium into the wet mixing granulator, add binder after mixing (mass concentration is 10%PVP- K30 (20% ethanol) solution), granulated;

[0042] 2) Dry the wet granules prepared in step 1) at 65°C, collect the granules when the moisture content of the granules reaches 1-3%, and sizing the granules with a fast granulator;

[0043] 3) Add tiopronin raw material and additional excipients (silicon dioxide and magnesium stearate), and mix;

[0044] 4) Determining the content of tiopronin in the mixed granules; compressing the mixed granules with qualified content into tablets to make tiopronin tablets (i.e. tiopronin plain tablets).

[0045] 5) Coating the prepared tiopronin tablets with enteric coating powder solution to make tiopronin enteric-coated tablets.

[004...

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Abstract

The invention relates to a preparation method of tiopronin tablets. The method comprises the following steps: (1) pelleting auxiliary materials, namely adding a diluent and a disintegrating agent into a binder, and pelleting the mixture by adopting a wet process; (2) drying and finishing pellets; (3) adding raw material tiopronin and additional auxiliary materials, and mixing; (4), tabletting to form tiopronin blank tablets; and (5) coating to form the tiopronin coated tablets. According to the preparation method of the tiopronin tablets, which is provided by the invention, the auxiliary materials, the diluent and the disintegrating agent are pelleted with the binder and are dried, and the raw material tiopronin and the additional auxiliary materials are added, mixed and tabletted, therefore, active ingredients in tiopronin can be protected against destroy due to wet and heat in a traditional wet method pelleting process, good stability of the tiopronin tablets is kept, and the problem that the traditional wet method pelleting process is not suitable for producing the tiopronin tablets is solved. The prepared tiopronin tablets are low in production cost, and the preparation operation is simple.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of tiopronin tablets. Background technique [0002] Tiopronin, chemical name: N-(2-mercaptopropionyl)-glycine, has a detoxification effect, protects liver tissue and cells, has a significant repair effect on alcohol-induced liver damage, and improves liver function. The pharmacological action is that tiopronin is a thiol-containing drug similar in nature to penicillamine, and has the effect of protecting liver tissue and cells. Animal experiments have shown that tiopronin can prevent liver damage caused by carbon tetrachloride, ethionine, acetaminophen, etc. by providing sulfhydryl groups, and can inhibit the accumulation of triglycerides in chronic liver damage; tiopronin It can reduce the activity of ATPase in the mitochondria of liver cells, thereby protecting the structure of liver mitochondria and improving liver function. In addition, tiopro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/195A61P1/16
Inventor 鲁科明匡跃进郜秋果
Owner YICHANG HEC CHANGJIANG PHARMA CO LTD
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