Vaccine cryoprotectant without composition of gelatin and human albumin

A technology for freeze-drying protective agent and human blood, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, and antibody medical ingredients, etc. Harmful, low cost, good safety effect

Active Publication Date: 2012-09-12
CHANGCHUN KEYGEN BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention discloses a vaccine freeze-drying protective agent without gelatin and human blood prote

Method used

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  • Vaccine cryoprotectant without composition of gelatin and human albumin
  • Vaccine cryoprotectant without composition of gelatin and human albumin
  • Vaccine cryoprotectant without composition of gelatin and human albumin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Weigh the following substances (g / l): dextran (40) 50, sucrose 50, lactose 20, mannitol 10, glycine 10, arginine 1.85, sodium glutamate 9.2, urea 4.6, 199 comprehensive medium 2, Fully dissolve the above-mentioned substances in an appropriate amount of sterilized water for injection, then constant volume, measure the osmotic pressure within the range of 300-450mosm, adjust the pH with 1N hydrochloric acid to within the range of 7.2-7.8, and finally sterilize and filter to obtain the obtained product.

Embodiment 2

[0019] Weigh the following substances (g / l): dextran (40) 20, sucrose 30, lactose 10, mannitol 5, glycine 5, arginine 1.85, sodium glutamate 9.2, urea 4.6, 199 comprehensive medium 2, Fully dissolve the above-mentioned substances in an appropriate amount of sterilized water for injection, then constant volume, measure the osmotic pressure within the range of 300-450mosm, adjust the pH with 1N hydrochloric acid to within the range of 7.2-7.8, and finally sterilize and filter to obtain the obtained product.

Embodiment 3

[0021] Weigh the following substances (g / l): dextran (40) 60, sucrose 60, lactose 25, mannitol 15, glycine 15, arginine 1.85, sodium glutamate 9.2, urea 4.6, 199 comprehensive medium 2, Fully dissolve the above-mentioned substances in an appropriate amount of sterilized water for injection, then constant volume, measure the osmotic pressure within the range of 300-450mosm, adjust the pH with 1N hydrochloric acid to within the range of 7.2-7.8, and finally sterilize and filter to obtain the obtained product.

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Abstract

The invention discloses a vaccine cryoprotectant without composition of gelatin and human albumin. The vaccine cryoprotectant comprises dextran (40), cane sugar, lactose, mannitol, glycine, arginine, sodium glutamate, urea and 199 synthetic medium. The invention does not contain ingredients of animal origin and the content of endotoxin of vaccine is greatly decreased, thus irritation and harm to a human body are greatly decreased and the vaccine has better safety and stability. Meantime, the cryoprotectant disclosed by the invention does not contain expensive raw materials such as trehalose and the like, thus the cryoprotectant has the advantage of low cost and is more applicable to industrialization.

Description

technical field [0001] The invention discloses a vaccine freeze-drying protectant without gelatin and human blood protein components, which does not contain animal-derived components, is used for freeze-drying protection of vaccines, and belongs to the technical field of vaccine production. Background technique [0002] The application of preventive vaccines has brought common epidemic infectious diseases under effective control, greatly reducing the morbidity and mortality of the above-mentioned infectious diseases. However, in the field of vaccine circulation, it is found that during the storage, transportation and clinical use of vaccines, there are problems such as poor stability, short validity period, high adverse reaction rate and potential hidden hazards. With the rapid development of biotechnology and in-depth research on the causes of adverse reactions, many problems have been found to be directly related to the protective agent and adjuvant of the vaccine, especi...

Claims

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Application Information

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IPC IPC(8): A61K47/36A61K39/00
Inventor 郑晓丽邹勇张勇李生军梁慧颖隋波郝宝双梁雪
Owner CHANGCHUN KEYGEN BIOLOGICAL PROD
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