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Reduced glutathione freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and glutathione, which is applied in the field of medicine to achieve the effects of improving safety, stimulating the ability of the immune system, quality controllability and stability

Inactive Publication Date: 2011-03-30
安英
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] In order to overcome the defects in the current reduced glutathione freeze-dried powder injection and its preparation process, the present invention provides a reduced glutathione freeze-dried powder injection with folic acid as an antioxidant and its preparation method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Take 30.00g of reduced glutathione, 12.00g of mannitol, and 0.20g of folic acid 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 10% sodium hydroxide, add water for injection To 200ml, detect the intermediate, filter it with a 0.22μm microporous membrane under sterile conditions, divide the filtrate into vials, 2ml per bottle, and then freeze-dry the product to obtain.

[0036] The reduced glutathione freeze-dried powder injection prepared by the above method meets the relevant testing items specified in the trial standard WS-900(X-665)-2002(1) for reduced glutathione freeze-dried powder injection requirements.

Embodiment 2

[0038] Take 60g of reduced glutathione, 16g of mannitol, and 0.20g of folic acid 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 400ml, Detect the intermediate, filter it with a 0.22 μm microporous membrane under aseptic conditions, divide the filtrate into vials, 4ml per bottle, and freeze-dry the product to obtain the product.

[0039] The reduced glutathione freeze-dried powder injection prepared by the above method meets the relevant testing items specified in the trial standard WS-900(X-665)-2002(1) for reduced glutathione freeze-dried powder injection requirements.

Embodiment 3

[0041] Put 90g of reduced glutathione, 30g of dextran, and 0.60g of folic acid 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 10% potassium hydroxide, add water for injection to 600ml, and test The intermediate is filtered with a 0.22 μm microporous membrane under sterile conditions, and the filtrate is divided into vials with 6ml each, and then the product is freeze-dried to obtain the product.

[0042] The reduced glutathione freeze-dried powder injection prepared by the above method meets the relevant testing items specified in the trial standard WS-900(X-665)-2002(1) for reduced glutathione freeze-dried powder injection requirements.

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Abstract

The invention discloses a reduced glutathione freeze-dried powder injection and a preparation method thereof. The powder injection is mainly made of the reduced glutathione and other proper accessories with specifications of 0.3 g (2 mL) per injection, 0.6 g (4 mL) per injection, 0.9 g (6 mL) per injection, 1.2 g (8 mL) per injection, 1.5 g (10 mL) per injection, and 1.8 g (12 mL) per injection. As the reduced glutathione freeze-dried powder injection of the invention uses folic acid as an antioxidant, a toxic side effect on human body caused by using sodium sulfite and sodium metabisulfite as the antioxidant can be avoided. Simultaneously, the folic acid can enhance human immunity so as to play a better efficacy. The reduced glutathione freeze-dried powder injection of the invention has good safety and efficacy. The preparation process thereof is simple, and good in quality controllability and stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a reduced glutathione freeze-dried powder injection and a preparation method 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 a sulfhydryl group (-SH). It is widely distributed in various organs of the body. It plays an important role in maintaining the biological function of cells. [0003] Glutathione is the prosthetic group of glyceraldehyde phosphate dehydrogenase, and the coenzyme of glyoxalase and triose phosphate dehydrogenase. It participates in the three shuttle cycle and glucose metabolism in the body, so that the human body can obtain high energy. The sulfhydryl group on glutathione cysteine ​​is its active group (so glutathione is often abbreviated as G-SH), and it is easy to react with heavy metal salts such as iodoacetic ac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/06A61K47/22A61P1/16A61P7/00A61P19/08A61P17/16A61P25/02A61P27/02A61P37/02A61P37/08A61P39/02A61P39/06
Inventor 安英张慧英张玲玲
Owner 安英
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