Method for preparing injection reduced glutathione freeze-dried powder

A technology of glutathione and reduced form, which is applied in the direction of freeze-drying transportation, tripeptide components, powder delivery, etc., can solve the problems of reduced glutathione moisture, easy to decompose and deteriorate the freeze-drying effect, and achieve good stability Good performance and product freeze-drying effect

Inactive Publication Date: 2012-09-19
双鹤药业(海南)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to supplement the deficiencies in the preparation process of the existing reduced glutathione preparation for injection, and to provide a preparation method of reduced glutathione freeze-dried powder for injection, which consists of formula selection, solution configuration and freezing Improve the control of the drying process to overcome the shortcomings of reduced glutathione, such as moisture, easy to decompose and deteriorate, and poor freeze-drying effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] The prescription of reduced glutathione freeze-dried powder for injection consists of: (by weight)

[0018] Reduced Glutathione 900g

[0019] Sodium bicarbonate 120g

[0020] Appropriate amount of water for injection

[0021] Weigh 120g of sodium bicarbonate, stir and dissolve to make 15% sodium bicarbonate solution, and set aside; measure 70% of the prepared sodium bicarbonate solution, add it to 900g of reduced glutathione and stir, and use the remaining bicarbonate Add the sodium solution dropwise to make it fully dissolved, adjust the pH of the solution to 4.9-5.5, make up the water for injection to the full amount, stir evenly, add 0.03% activated carbon to stir, decarbonize and filter, and set aside; take the filtrate and fill it in a vial, freeze as follows Drying curve freeze-drying: when the shelf temperature of the freeze-drying machine drops to -10°C, put the filled qualified product on the shelf of the freeze-drying box, cool down at a rate of 30°C / h until...

Embodiment 2

[0023] The prescription of reduced glutathione for injection consists of: (by weight)

[0024] Reduced Glutathione 600g

[0025] Sodium hydroxide 90g

[0026] Appropriate amount of water for injection

[0027] Weigh 90g of sodium hydroxide, stir and dissolve to form a 15% sodium hydroxide solution, and set aside; measure 70% of the prepared sodium hydroxide solution, add it to 600g of reduced glutathione and stir, and oxidize it with the remaining hydroxide Add the sodium solution dropwise to make it fully dissolved, adjust the pH of the solution to 4.9-5.5, make up the water for injection to the full amount, stir evenly, add 0.03% activated carbon to stir, decarbonize and filter, and set aside; take the filtrate and fill it in a vial, freeze as follows Drying curve freeze-drying: when the shelf temperature of the freeze-drying machine drops to -10°C, put the filled qualified product on the shelf of the freeze-drying box, cool down at a rate of 30°C / h until the product tempe...

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PUM

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Abstract

The invention provides a method for preparing injection reduced glutathione freeze-dried powder widely used for auxiliary treatment of multi-system or multi-organ diseases such as liver or kidney injury and diabetes. According to the method, reduced glutathione is used as an active ingredient and added with a pH regulator and injection water, and the injection reduced glutathione freeze-dried powder is prepared by freeze-drying. For overcoming the defects of the conventional technology for preparing the injection reduced glutathione freeze-dried powder, the invention provides the method for preparing the injection reduced glutathione freeze-dried powder. The reduced glutathione freeze-dried powder is prepared by strictly controlling formulation selection, solution preparation and freeze-drying processes; and although the method is long in freeze-drying time, the reduced glutathione freeze-dried powder prepared by the method is high in stability and has a good freeze-dried effect.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of reduced glutathione freeze-dried powder for injection. Background technique: [0002] Reduced glutathione (GSH) is a tripeptide naturally synthesized in human cells. It is composed of glutamic acid, cysteine ​​and glycine, and contains sulfhydryl (-SH). It is widely distributed in various organs of the human body. It plays an important role in maintaining the biological functions of cells and protecting the integrity of cell membranes. As an important regulatory metabolic substance in cells, reduced glutathione is not only the prosthetic group of glyceraldehyde phosphate dehydrogenase, but also the coenzyme of glyoxalase and triose dehydrogenase, and participates in the tricarboxylic acid cycle in the body And sugar metabolism, and can activate a variety of enzymes, such as sulfhydryl (-SH) enzyme-coenzyme, etc., thereby promoting sugar, fat an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/06A61P1/16A61P3/10A61P13/12A61P39/06
Inventor 魏雪纹李强
Owner 双鹤药业(海南)有限责任公司
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