Prefreezing method in preparing injection-used reduced glutathione with freeze drying method

A technology of glutathione and reduced form, which is applied in freeze-dried transportation, tripeptide components, anti-toxins, etc., can solve problems such as difficult manipulation, unstable quality, and high scrap rate, and achieve the goal of overcoming manipulation difficulties, ensuring medication safety, The effect of improving product quality

Active Publication Date: 2010-02-17
上海复旦复华药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The technical problems to be solved by the present invention are: 1. In the preparation process of the existing reduced glutathione freeze-dried powder injection, it is necessary to first freeze-dry the raw material and then pulverize it, and then carry out aseptic packaging according to the specifications, resulting in the product The defects of poor appearance, unstable quality, and high scrap rate; 2. Overcome the defects in the prior art that the preparation of reduced glutathione freeze-dried powder injection requires the addition of excipients as the crystal skeleton proppant to bring quality risks; 3. To overcome the defect in the prior art that it is necessary to control the temperature of the shelf and the product during the pre-freezing stage of the preparation of the reduced glutathione freeze-dried powder injection, resulting in difficult control defects, and discovered the formation and composition of reduced glutathione crystals The key control parameters of the skeleton structure, and the oxidized glutathione formed by controlling the oxidative denaturation of the reduced glutathione pre-freezing ...

Method used

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  • Prefreezing method in preparing injection-used reduced glutathione with freeze drying method
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  • Prefreezing method in preparing injection-used reduced glutathione with freeze drying method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] First add about 25L of water for injection into the sterilized liquid preparation pot, control the water temperature below 40°C, add 4.1Kg of reduced glutathione, stir evenly, add about 5.4L of 10% sodium hydroxide, and stir at the same time to dissolve and clarify , add water for injection to a total of 82L, and adjust the pH value to 4.8-5.8. After the analysis is qualified, the liquid medicine is first filtered with a 0.45 μm filter, and then sterilized with a 0.22 μm microporous filter membrane. Pack in 10ml control bottles, 0.1g / 2ml per bottle, check the accuracy of the filling every half hour. After the filling is finished, the machine will automatically half-stopper, then put the filled product into the suction chassis and send it into the freeze-drying box in time, and close the box door. Reduce the product temperature from room temperature to -40°C within 1.5 to 2 hours, and keep it warm for 1 hour; within 2 hours, raise the product temperature from -40°C to -1...

Embodiment 2

[0040] First add about 30L of water for injection into the sterilized liquid preparation pot, control the water temperature below 40°C, add 12.3Kg of reduced glutathione, stir evenly, add about 16.2L of 10% sodium hydroxide, and stir at the same time to dissolve and clarify , add water for injection to a total of 82L, and adjust the pH value to 4.8-5.8. After the analysis is qualified, the liquid medicine is first filtered with a 0.45 μm filter, and then sterilized with a 0.22 μm microporous filter membrane. Pack in 10ml control bottles, 0.3g / 2ml per bottle, check the accuracy of the filling every half hour. After the filling is finished, the machine will automatically half-stopper, then put the filled product into the suction chassis and send it into the freeze-drying box in time, and close the box door. Reduce the product temperature from room temperature to -40°C within 1.5 to 2 hours, and keep it warm for 1 hour; within 2 hours, raise the product temperature from -40°C to ...

Embodiment 3

[0042] First add about 30L of water for injection into the sterilized liquid preparation pot, control the water temperature below 40°C, add 24.6Kg of reduced glutathione, stir evenly, add about 32.4L of 10% sodium hydroxide, and stir at the same time to dissolve and clarify , add water for injection to a total of 82L, and adjust the pH value to 4.8-5.8. After the analysis is qualified, the liquid medicine is first filtered with a 0.45 μm filter, and then sterilized with a 0.22 μm microporous filter membrane. Packed in 10ml control bottles, 0.6g / 2ml per bottle, check the accuracy of the filling every half hour. After the filling is finished, the machine will automatically half-stopper, then put the filled product into the suction chassis and send it into the freeze-drying box in time, and close the box door. Reduce the product temperature from room temperature to -40°C within 1.5 to 2 hours, and keep it warm for 1 hour; within 2 hours, raise the product temperature from -40°C t...

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Abstract

The invention discloses a prefreezing method in preparing injection-used reduced glutathione with a freeze drying method, comprising the following steps: (1) quantitatively split charging reduced glutathione solution into each tube-type bottle according to the specification of a final product, lowering the temperature below -40 DEG C in 1.5-2 hours, and keeping the temperature for 1 hour to obtaina reduced glutathione solution freezing body; (2) rising the temperature of the reduced glutathione solution freezing body obtained in step (1) to -17 DEG C in two hours, and keeping the temperaturefor one hour; (3) lowering the temperature of the reduced glutathione solution freezing body obtained in step (2) below -40 DEG C within 1-1.5 hours, and keeping the temperature for one hour. After the prefreezing method of the invention is adopted, the obtained substance is sublimated and dried to obtain a white loose block product, and surface has no appearance defect. The product obtained by the prefreezing method of the invention has small possibility of erupting in the production process, and the quality of the final product conforms to the national standard.

Description

technical field [0001] The invention specifically relates to a prefreezing method when preparing reduced glutathione for injection by a freeze-drying method. Background technique [0002] Reduced glutathione (GSH) 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 maintaining the biological functions of cells. It is often used in chemotherapy patients, radiation therapy patients, various hypoxemia, liver disease and liver damage caused by toxicity of other chemicals. [0003] Reduced glutathione is unstable in water and sensitive to heat, so it is generally made into powder injection by freeze-drying method for clinical application. [0004] The process of preparing powder injections by freeze-drying method is generally divided into two stages: first, the product to be freeze-dried is divided into suitable containers and placed on a metal plate suitable f...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/06A61P39/06A61P1/16
Inventor 余技明任昉
Owner 上海复旦复华药业有限公司
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