Tiopronin injection and preparation method thereof

A technology of tiopronin and injection, which is applied in the field of medicine and can solve problems such as influence on drug application, danger, harsh production conditions, etc.

Active Publication Date: 2005-11-23
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above varieties need to be dissolved in water during clinical application, which is very likely to cause insufficient drug dissolution and cause danger when injected into humans.
However, the production process of freeze-dried powder injection has strict requirements on equipment, harsh production conditions, and high energy consumption, which is not conducive to large-scale industrial production.
And, the stability of tiopronin in water is poor, has directly influenced the application of this medicine in clinical

Method used

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  • Tiopronin injection and preparation method thereof
  • Tiopronin injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Take 100g of tiopronin, 0.1g of calcium sodium edetate as auxiliary material, and 2000ml of water for injection; nitrogen gas is passed through the water for injection for 30 minutes, and set aside. Add all the tiopronin into the prepared water for injection that has been purged with nitrogen, stir to dissolve, add all the auxiliary materials edetate calcium sodium, stir to dissolve; adjust the pH value of the above mixed solution to 5 with sodium hydroxide solution Add 0.02% (g / ml) activated carbon for needles according to the liquid volume, stir under nitrogen for 20 minutes, filter with a 0.45 μm microporous membrane until the filtrate clarity meets the requirements of the Chinese Pharmacopoeia 2005 edition; take the conventional process Fill the cleaned ampoule with the filtrate. After filling, pass nitrogen gas into the ampoule until the air in the ampoule is emptied, and seal it quickly after ventilating; sterilize the sealed ampoule at 100°C for 15 minutes under t...

Embodiment 2

[0065] Get tiopronin 150g, adjuvant calcium sodium edetate 0.1g, water for injection 2000ml, other steps are with embodiment 1.

Embodiment 3

[0067] Get tiopronin 80g, auxiliary material edetate disodium 0.1g, water for injection 2000ml, other steps are with embodiment 1.

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Abstract

The invention relates to a tiopronin injection and preparation method, which overcomes the tiopronin's shortcoming of poor stability in water, and provides a tiopronin injection. The invention also provides the process for preparing the tiopronin injection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and mainly relates to tiopronin injection and a preparation method thereof. Background technique [0002] Tiopronin (MPG) is a compound containing mercaptoglycine, which can improve liver function. Chemical name: N-(2-mercaptopropionyl)-glycine [0003] The structural formula is as follows: [0004] [0005] At present, the pharmaceutical preparations of tiopronin include tablets and powder for injection. Patent application CN1488343 A discloses a kind of tiopronin freeze-dried powder injection. However, the above varieties need to be dissolved with water during clinical application, which is very likely to cause insufficient drug dissolution and cause danger when injected into people. However, the production process of freeze-dried powder injection has strict requirements on equipment, harsh production conditions, and high energy consumption, which is not conducive to large-scale industr...

Claims

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Application Information

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IPC IPC(8): A61K31/197
Inventor 杜振新卢秀莲邢晋华王绍同薛长明李大涛李明丽贾涛刘同欣
Owner CISEN PHARMA
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