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Freeze dried composition containing thiopronin and its preparation method

A technology of tiopronin and composition, applied in the field of medicine and its preparation, can solve the problems of complicated clinical injection operation, unsafe, high relative breakage rate

Inactive Publication Date: 2005-10-26
广州名冠医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The special solvent that commercially available injection tiopronin is equipped with is 2ml sodium bicarbonate injection (5%), when diluting, the H produced by acid-base neutralization 2 CO 3 Part becomes CO 2 The escape of gas will easily increase the pressure inside the medicine bottle, and there is a danger of the bottle bursting in hot weather, which poses a hidden danger of unsafety
The water needle packaged in glass ampoule as a special solvent has a relatively high breakage rate, which brings some inconvenience to transportation and packaging. At the same time, it also makes the clinical injection operation more cumbersome.
Since each commercially available tiopronin freeze-dried powder injection must be equipped with a special solvent (water injection), it is necessary to have both freeze-dried powder injection and water injection production lines to produce products that can be used clinically. As a result, the cost increases, which increases the financial burden of patients accordingly
[0007] For those skilled in the art, there is no clear report on the solution of making tiopronin into freeze-dried powder for direct injection without the need for special solvent dissolution

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] prescription

[0045] Dosage per 1000 bottles

[0046] Tiopronin 100g

[0047] Arginine 100g

[0048] Get the prescribed amount of arginine and put it in newly prepared sterile water for injection to dissolve, add the prescribed amount of tiopronin under stirring to make it completely dissolve, add activated carbon to the solution, and filter until the solution is clarified. Measure the pH value of the crude solution. 4.0-7.5, add water for injection to the theoretical amount (1.0-1.5ml solution contains 100mg tiopronin), fine filter the coarse filtrate at 0.22μm, measure and adjust the pH value of the fine filtration solution to 4.0-7.5, and measure the main drug content, the fine filtrate is filled, the vial is half-stoppered, and vacuum freeze-dried so that the final moisture content of the freeze-dried composition is controlled at less than 5%, and finally the finished product is obtained by corking, capping and packaging.

Embodiment 2

[0050] prescription

[0051] Dosage per 1000 bottles

[0052] Tiopronin 10g

[0053] Arginine 115g

[0054] Get the prescribed amount of arginine and put it in newly prepared sterile water for injection to dissolve, add the prescribed amount of tiopronin under stirring to make it completely dissolve, add activated carbon to the solution, and filter until the solution is clarified. Measure the pH value of the crude solution. 4.0-7.5, add water for injection to the theoretical amount (1.0-1.5ml solution contains 100mg tiopronin), fine filter the coarse filtrate at 0.22μm, measure and adjust the pH value of the fine filtration solution to 4.0-7.5, and measure the main drug content, the fine filtrate is filled, the vial is half-stoppered, and vacuum freeze-dried so that the final moisture content of the freeze-dried composition is controlled at less than 5%, and finally the finished product is obtained by corking, capping and packaging.

Embodiment 3

[0056] prescription

[0057] Dosage per 1000 bottles

[0058] Tiopronin 100g

[0059] Lysine 75g

[0060] Get the prescribed amount of lysine and put it in newly made sterile water for injection to dissolve, add the prescribed amount of tiopronin under stirring to make it dissolve completely, add activated carbon to the solution, and filter until the solution is clear, then measure the pH value of the crude solution 4.0-7.5, add water for injection to the theoretical amount (1.0-1.5ml solution contains 100mg tiopronin), fine filter the coarse filtrate at 0.22μm, measure and adjust the pH value of the fine filtration solution to 4.0-7.5, and measure the main drug content, the fine filtrate is filled, the vial is half-stoppered, and vacuum freeze-dried so that the final moisture content of the freeze-dried composition is controlled at less than 5%, and finally the finished product is obtained by corking, capping and packaging.

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PUM

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Abstract

A freeze-dried composite of tripronin is proportionally prepared from tripronin and alkaline medicinal additive. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to the field of medicines and preparations thereof. Specifically, the invention relates to a freeze-dried composition containing tiopronin and a preparation method thereof. Background technique [0002] Tiopronin, English name tioponin, chemical name N-(2-mercaptopropionyl)-glycine, is a hepatoprotective drug. Long-term use at home and abroad has proved that the drug can comprehensively and significantly improve liver function indicators and related symptoms of viral hepatitis and alcoholic liver injury, and has the characteristics of definite curative effect, safety and reliability. Clinically, it is mainly used for the treatment of: viral hepatitis, alcoholic hepatitis, drug-induced hepatitis, heavy metal poisoning hepatitis, fatty liver and early cirrhosis; reduce the toxic and side effects of radiotherapy and chemotherapy, increase white blood cells and accelerate the recovery of liver cells, reduce Bone marrow chromosomal ab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/197
Inventor 王巍嵩柳瑜王文菊于志林孟勇涛
Owner 广州名冠医药科技有限公司
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