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Stable solution containing tiopronin for injection

A technology for tiopronin and injection, which is applied in the field of stable solutions, can solve the problems of inconvenience and poor stability of tiopronin, and achieve the effects of convenient medication, improved stability and reduced cost

Inactive Publication Date: 2005-12-07
合肥霄云科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tiopronin aqueous injection is an aqueous solution of 5% tiopronin sodium salt filled with 2ml or 5ml of concentration in every ampule, wherein the stability of tiopronin is

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Preparation Process:

[0017] In the preparation container, add 50% water for injection, after adding tiopronin to dissolve, slowly add sodium bicarbonate in stages, stir to dissolve completely, control the pH of the solution within the range of 7.0-8.0, add pre-prepared The mixed solution of cysteine, sodium calcium edetate and benzyl alcohol was stirred evenly, and then 0.2% activated carbon for needles was added, heated, kept at a slight boil for 30 minutes, and filtered while hot to decarbonize. Dilute the concentrated solution with water for injection to the required amount, measure the pH and content, filter until clear, fill, seal, sterilize with steam at 100°C for 30 minutes, light inspection, printing, and packaging.

[0018] After inspection, the sample solution prepared according to the above method is stable in properties, and the technological process does not affect the stability of tiopronin. The property of this product is stable in the destructi...

Embodiment 2

[0021] Preparation Process:

[0022] In the preparation container, add 50% water for injection, add tiopronin to dissolve, adjust pH in the range of 7.0-8.0 with sodium hydroxide solution, add pre-prepared mixed solution of methionine and disodium edetate, Stir evenly, then add 0.1% activated carbon for needles, heat, keep boiling slightly for 30 minutes, filter while hot to decarbonize. Dilute the concentrated solution with water for injection to the required amount, measure the pH and content, filter until clear, fill, seal, sterilize with steam at 100°C for 30 minutes, light inspection, printing, and packaging.

[0023] After inspection, the sample solution prepared according to the above method is stable in properties, and the technological process does not affect the stability of tiopronin. The property of this product is stable in the destruction experiment under the condition of circulating steam at 100°C and sterilizing for 30 minutes.

Embodiment 3

[0026] Preparation Process:

[0027] Heat the water for injection in an appropriate amount to boiling, add the prescribed amount of cysteine, edetate sodium calcium and sodium chloride to make the concentration 70%-80%, stir to dissolve, cool, add the prescribed amount of tiopronin, and use Sodium hydroxide solution to adjust the pH value, control the pH of the solution in the range of 7.0-8.0, stir to make the mixture uniform, add 0.2% activated carbon for needles, heat, keep slightly boiling for 20 minutes, filter while hot to decarbonize. Dilute the concentrated solution with water for injection to the required amount, measure the pH and content to pass, filter until clear, fill, add film, cover with rubber stopper, and rolled aluminum cap. After autoclaving at 115°C for 30 minutes, light inspection is done.

[0028] After inspection, the sample solution prepared according to the above method is stable in properties, and the technological process does not affect the...

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PUM

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Abstract

The invention relates to a stable solution containing tiopronin for injection which comprises tiopronin and anti-oxidant as anti-oxidant, wherein the chelating agent is calcium disodium edeate, the acidity regulator is natrium hydroxydatum, osmoregulation agent is sodium chloride, and the bacteria inhibitor is benzoic alcohol. The invention can effectively guarantee the constancy of t he injections during storage and application. The product employs a dosage form of transfusion, thus is especially suitable for in-hospital treatment and patients with difficulty in deglutition.

Description

technical field [0001] The invention relates to a stable solution for injection containing tiopronin. Background technique [0002] Tiopronin (English name: tiopronin) is a glycine derivative containing a free sulfhydryl group. Its pharmacological effects are mainly: [0003] 1. Protective effect on liver tissue and cells ①Repair effect on multiple types of liver damage: Tiopronin can prevent liver damage caused by carbon tetrachloride, ethionine, toadstool powder and paracetamol, and can prevent liver damage caused by four types of liver damage. Hepatic necrosis caused by carbon chloride. Tiopronin can accelerate the degradation and excretion of ethanol and acetaldehyde, prevent the accumulation of triglycerides, and have a significant repairing effect on alcoholic liver damage. ②Protect the structure of liver mitochondria and improve liver function Tiopronin can reduce the ATPase activity in the mitochondria of liver cells, increase the ATP content, and restore the elec...

Claims

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Application Information

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IPC IPC(8): A61K31/195
Inventor 曹铁军高翱
Owner 合肥霄云科技有限公司
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