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Lyophilized powder injection of glutathione and preparation process thereof

A technology of freeze-dried powder injection and glutathione, which is applied in the direction of freeze-dried transportation, tripeptide composition, powder transportation, etc., can solve the problems of easy pollution, difference in loading, poor solubility and clarity, etc., and achieve improvement Medication safety, stable quality, and quality-improving effects

Inactive Publication Date: 2007-05-30
SHANDONG LUYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the dosage form of reduced glutathione for injection is powder injection. The powder injection mainly includes sterile powder and freeze-dried powder injection. Due to many problems in the preparation process of sterile powder, such as the difference in filling volume, solubility And clarity is poor, easy to cause pollution, especially when it comes to biochemical drugs, the requirements for raw materials and preparation processes are higher

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Take 12kg of reduced glutathione and 2kg of mannitol in a sterile container, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 5.0-6.5 with 0.1mol / L sodium hydroxide, add water for injection to 40000ml, and test The intermediate is filtered with a 0.22 μm microporous membrane under sterile conditions, and the filtrate is divided into vials with 4ml each, and then the product is freeze-dried to obtain the product.

Embodiment 2

[0027] Take 6kg of reduced glutathione and 1.5kg of mannitol in a sterile container, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 5.0-6.5 with 1M sodium carbonate solution, add water for injection to 20000ml, and detect the intermediate , filtered with a 0.22μm microporous membrane under sterile conditions, the filtrate was divided into vials, 2ml per bottle, and then the product was freeze-dried.

Embodiment 3

[0029] Put 18kg of reduced glutathione and 3.6kg of dextran in a sterile container, add an appropriate amount of water for injection and stir to dissolve, adjust the pH value to 5.0-6.5 with 0.1mol / L sodium hydroxide, add water for injection to 60000ml, Detect the intermediate, filter it with a 0.22 μm microporous membrane under sterile conditions, divide the filtrate into 6ml vials, and freeze-dry the product.

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PUM

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Abstract

The invention discloses a reduced-type glutathione freeze dried injection and making technique, which is characterized by the following: loading 95.0%-105.0% reduced-type glutathione (C10H17N3O6S) to display white block and powder; testing nitrosoferric sodium cyanide to display red; keeping the consistent reserving time of main peak of sample solution as comparison sample solution with pH value at 5.0-6.5; making dried weight not over 5.0% and the content of relative material not more than 4%; limiting the content of bacterial endotoxin less than 0.125EU; making other items satisfy the standard.

Description

technical field [0001] The invention relates to a glutathione freeze-dried powder injection and a preparation process thereof, in particular to a reduced glutathione freeze-dried powder injection and a preparation process thereof. Background technique [0002] Reduced glutathione (GSH) is a polypeptide naturally synthesized in human cytoplasm. It is composed of glutamic acid, cysteine ​​and glycine, and contains sulfhydryl (-SH). It is widely distributed in various organs of the body. important role in cell biological function. [0003] Reduced glutathione is mainly used clinically for chemotherapy patients and radiation therapy patients; various hypoxemias: such as acute anemia, adult respiratory distress syndrome, sepsis, etc.; liver diseases, including viral, drug toxicity, alcohol toxicity and other chemical substance toxicity caused by liver damage; can also be used for adjuvant treatment of organophosphorus, amine or nitro compound poisoning. [0004] At present, the...

Claims

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Application Information

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IPC IPC(8): A61K38/06A61K9/19A61P35/00
Inventor 李世旭林彤慧
Owner SHANDONG LUYE PHARMA CO LTD
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