Lyophilization process of glutathione for injection

A technology of glutathione and reduced form, which is applied in the direction of freeze-dried transportation, tripeptide components, anti-toxic agents, etc., can solve problems such as unstable quality, insufficient loading, and instability, so as to achieve stable product quality and improve drug safety , Guarantee the effect of quality

Inactive Publication Date: 2007-07-11
上海复旦复华药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug is unstable in aqueous solution, and cannot be made into water-soluble injection, let alone heat sterilized in aqueous solution, and can only be made into sterile powder for injection by aseptic operation method for clinical use
[0003] The existing technology can be divided into two types. The first one is to freeze-dry the raw materials, and then carry out powder filling after crushing and sieving under aseptic conditions. Although the cost of freeze-drying is relatively low, the Reduced glutathione powder for injection is easy to absorb moisture, easy to decompose and deteriorate, affect the safety of medication, and easily cause insufficient filling
The second is to directly aseptically subpackage the drug into a liquid, and then freeze-dry it. The advantage is that the difference in loading is easy to control and the stability of the drug can be enhanced. The disadvantage is that the cost is high, especially for the reduced form of gluten. As far as glutathione is concerned, the freeze-drying conditions are not easy to control, resulting in a high waste rate, and even affecting the stability of the drug within the validity period
The existing second method is not effective for the product of reduced glutathione. The industry believes that this product is difficult, mainly because the control of the freeze-drying process has not found the appropriate temperature and time, resulting in the appearance of the drug. Well, the product will shrink after freeze-drying, that is, the scrap rate in commercial production is high, and the quality from batch to batch is not stable, maybe one batch of product is good and the next batch is not good

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The reduced glutathione for injection after subpackaging is freeze-dried by the following steps;

[0030] a. Evenly put the bottle containing the liquid medicine into the freeze dryer;

[0031] b. Reduce the shelf temperature of the freeze dryer to -40°C at a rate of 30°C per hour;

[0032] c. The temperature of the product is -35°C, and the temperature is kept for 1 hour;

[0033] d. Return the temperature of the shelf to -20°C and keep it warm for 1 hour;

[0034] e. Then lower the temperature of the shelf to -40°C, lower the temperature of the product to -35°C, and keep it warm for 2 hours;

[0035] f. Start vacuuming, when the vacuum reaches 6Pa, start heating up;

[0036] g. Increase the shelf temperature to -10°C in one step until the product temperature is -8°C and then keep it for 2 hours;

[0037] h. Then increase the temperature of the shelf to 0°C in one step until the product temperature is 0°C and then keep it for 2 hours;

[0038] i. Increase the shel...

Embodiment 2

[0041] Use the following steps to freeze-dry the reduced glutathione for injection after subpackaging:

[0042] a. Evenly put the bottle containing the liquid medicine into the freeze dryer;

[0043] b. Reduce the shelf temperature of the freeze dryer to -40°C at a rate of 30°C per hour;

[0044] c. The temperature of the product is -35°C, and the temperature is kept for 1 hour;

[0045] d. Return the temperature of the shelf to -20°C and keep it warm for 1 hour;

[0046] e. Then lower the temperature of the shelf to -42°C, lower the temperature of the product to 38°C, and keep it warm for 2 hours;

[0047] f. Start vacuuming, when the vacuum reaches 8Pa, start heating up;

[0048] g. Increase the shelf temperature to -10°C in one step until the product temperature is -8°C and then keep it for 2 hours;

[0049] h. Then raise the shelf temperature to 0°C in one step until the product temperature reaches 10°C and keep it for 2 hours;

[0050] i. Increase the shelf temperatu...

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PUM

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Abstract

The invention relates to a freezing technique of injection reduction glutathione, wherein it comprises that: packing liquid reduction glutathione; freezing and drying. The invention can standardize the freezing technique of injection reduction glutathione, with stable product quality and high yield, to improve intake safety.

Description

technical field [0001] The invention relates to the field of pharmaceutical technology preparation, in particular to a freeze-drying process for preparing reduced glutathione for injection. Background technique [0002] Glutathione is widely distributed in the cells of mammals, plants and microorganisms. It is an important antioxidant component in the biochemical system and plays an important role in the biochemical metabolism of the liver. The medicine is unstable in aqueous solution, and cannot be made into water-soluble injection, let alone heat-sterilized in aqueous solution, and can only be made into sterile powder for injection by aseptic operation for clinical use. [0003] The existing technology can be divided into two types. The first one is to freeze-dry the raw materials, and then carry out powder filling after crushing and sieving under aseptic conditions. Although the cost of freeze-drying is relatively low, the Reduced glutathione powder for injection is easy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/06A61K9/19A61P39/02A61P1/16A61P17/00A61P27/12
Inventor 朱泽龙
Owner 上海复旦复华药业有限公司
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