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Production of injecting reductive glutathione

A technology of glutathione and sodium glutathione, which is applied to medical preparations, pharmaceutical formulas, and digestive systems containing active ingredients, can solve the problem that reduced glutathione is easy to oxidize, and moisture and related substances are easy to exceed the standard. and other problems, to achieve the effect of high uniformity, stable product quality and easy operation

Active Publication Date: 2007-11-21
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a preparation method of reduced glutathione for injection, to solve the problem that the moisture and related substances in the existing products are easy to exceed the standard
[0005] The inventors used nitrogen protection in the whole production process of reduced glutathione for injection to solve the problem of easy oxidation of reduced glutathione

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Take 1.6kg of sodium hydroxide, add appropriate amount of cooling water for injection to prepare sodium hydroxide solution. Take an appropriate amount of water for injection, cool it down, inject sterile nitrogen gas for 15-20 minutes, and then add 12kg of glutathione to make a suspension. Under the condition that both the sodium hydroxide solution and the suspension are fed with sterile nitrogen and airtight, the sodium hydroxide solution is slowly added to the glutathione suspension, and the pH value of the solution is adjusted to 5.2-5.4. Add water for injection to the full amount, continue to pass in sterile nitrogen, stir evenly, and filter aseptically. Fill into shallow freeze-drying trays, fill each tray with 7kg, first keep at -20°C for 3 hours, then rise to -5°C within 2 hours, keep at -5°C for 1 hour, and then drop to - within 1.5 hours Keep it at 42°C for 2 hours, vacuumize, raise the temperature to 50-53°C, keep it warm for 13-14 hours, after freeze-drying ...

Embodiment 2

[0028] Take 1.6kg of sodium hydroxide, add appropriate amount of cooling water for injection to prepare sodium hydroxide solution. Take an appropriate amount of water for injection, cool it down, inject sterile nitrogen gas for 15-20 minutes, and then add 12kg of glutathione to make a suspension. Under the condition that both the sodium hydroxide solution and the suspension are fed with sterile nitrogen and airtight, the sodium hydroxide solution is slowly added to the glutathione suspension, and the pH value of the solution is adjusted to 5.2-5.4. Add water for injection to the full amount, continue to pass in sterile nitrogen, stir evenly, and filter aseptically. Fill into shallow freeze-dried trays, fill each tray with 7kg, first keep at -30°C for 3 hours, then rise to -5°C within 2 hours, keep at -5°C for 1 hour, and then drop to - within 1.5 hours Keep it at 42°C for 2 hours, vacuumize, raise the temperature to 50-53°C, keep it warm for 13-14 hours, after freeze-drying i...

Embodiment 3

[0030] Take 1.6kg of sodium hydroxide, add appropriate amount of cooling water for injection to prepare sodium hydroxide solution. Take an appropriate amount of water for injection, cool it down, inject sterile nitrogen gas for 15-20 minutes, and then add 12kg of glutathione to make a suspension. Under the condition that both the sodium hydroxide solution and the suspension are fed with sterile nitrogen and airtight, the sodium hydroxide solution is slowly added to the glutathione suspension, and the pH value of the solution is adjusted to 5.2-5.4. Add water for injection to the full amount, continue to pass in sterile nitrogen, stir evenly, and filter aseptically. Fill into shallow freeze-drying trays, 7kg per tray, first keep at -20°C for 3 hours, then rise to -1°C within 2 hours, keep at -1°C for 1 hour, and then drop to - within 1.5 hours Keep it at 42°C for 2 hours, vacuumize, raise the temperature to 50-53°C, keep it warm for 13-14 hours, after freeze-drying is complete...

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PUM

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Abstract

Production of injection reducing glutathione is carried out by pre-freezing for reducing glutathione solution and freeze-drying. It's simple, cheap, has stable product quality and less water content and related substances and can be used for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for preparing reduced glutathione for injection. Background technique [0002] Glutathione is widely distributed in the cells of mammals, plants and microorganisms. It is the most important and abundant low-molecular-weight active peptide containing sulfhydryl groups. It is an important antioxidant component in the biochemical system and plays an important role in the biochemical metabolism of the liver. Clinically, it is mainly used as a drug for detoxification and anti-oxidation, to prevent and treat chemotherapy and drug-induced liver damage in cancer patients, to treat chronic fatty liver, to treat viral hepatitis and cirrhosis, etc. [0003] Reduced glutathione is sensitive to heat, is unstable in aqueous solution, has high viscosity, and is easily oxidized. All of the above situations can easily cause the increase of related substances. Therefore, a stab...

Claims

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Application Information

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IPC IPC(8): C07C233/05A61K31/197A61P35/00A61P1/16A61P39/02
Inventor 张正君陈彦
Owner YAOPHARMA CO LTD
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