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Freeze-drying protective additive and application thereof, freeze-dried vaccine and production method of freeze-dried vaccine

A freeze-drying protective agent and freeze-drying technology, applied in the direction of freeze-drying transportation, medical preparations of non-active ingredients, pharmaceutical formulas, etc., can solve problems that need to be improved, and achieve less adverse reactions, less allergic reactions, and high safety Effect

Active Publication Date: 2020-08-28
成都可恩生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] It can be known from the above prior art that in preventive vaccine products, since the protective agent without gelatin can reduce the irritation to the human body, it has been widely promoted and applied in various vaccine products at present, but the protection of bacteria The effect needs to be improved, especially as a therapeutic BCG, because live bacterial biological preparations are used, so it is especially important to strengthen the stability of BCG in the freeze-drying process and storage process to ensure the quality of clinical medication

Method used

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  • Freeze-drying protective additive and application thereof, freeze-dried vaccine and production method of freeze-dried vaccine
  • Freeze-drying protective additive and application thereof, freeze-dried vaccine and production method of freeze-dried vaccine
  • Freeze-drying protective additive and application thereof, freeze-dried vaccine and production method of freeze-dried vaccine

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Effect test

Embodiment 1

[0042] This embodiment relates to a lyoprotectant of BCG for treatment.

[0043] The preparation concentration of each component of the lyoprotectant is: sucrose: 10%, dextran 40: 0.5%, sodium glutamate: 1%, KCL: 1%, and the solvent for preparing the lyoprotectant is water for injection, with 10% Sodium hydroxide solution adjusts the pH value of the lyoprotectant to 7.33. The lyoprotectant was subpackaged and then sterilized by high pressure steam at 116° C. for 40 minutes.

Embodiment 2

[0045] This embodiment relates to a lyoprotectant of BCG for treatment.

[0046] The preparation concentration of each component of the lyoprotectant is: sucrose: 10%, dextran 40: 2.0%, sodium glutamate: 1%, KCL: 1%, and the solvent for preparing the lyoprotectant is water for injection, with 10% The sodium hydroxide solution adjusted the pH of the lyoprotectant to 7.48. The lyoprotectant was subpackaged and then sterilized by high pressure steam at 116° C. for 40 minutes.

Embodiment 3

[0048] This embodiment relates to a lyoprotectant of BCG for treatment.

[0049] The formulation concentration of each component of the lyoprotectant is: sucrose: 10%, dextran 40: 1%, sodium glutamate: 1%, KCL: 1%, and the solvent for preparing the lyoprotectant is water for injection, with 10% Sodium hydroxide solution adjusts the pH value of the lyoprotectant to 7.41. The lyoprotectant was subpackaged and then sterilized by high pressure steam at 116° C. for 40 minutes.

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Abstract

The invention discloses a freeze-drying protective additive and application thereof, a freeze-dried vaccine and a production method of the freeze-dried vaccine. Production concentrations of componentsof the freeze-drying protective additive are as follows: the production concentration of sucrose is 10%, the production concentration of dextran is 0.5-2.0%, the production concentration of sodium glutamate is 1%, the production concentration of KCL is 1% or the production concentration of sucrose is 10%, the production concentration of dextran is 1%, the production concentration of trehalose is1-5%, the production concentration of sodium glutamate is 1%, and the production concentration of KCL is 1%; and a solvent for producing the freeze-drying protective additive is injection water, and apH value of the freeze-drying protective additive is adjusted by means of a 10% sodium hydroxide solution to be 7.3-7.5. The freeze-drying protective additive does not contain gelatin, is used for producing a bacillus calmette guerin vaccine used for freeze-drying treatment, can reduce an endotoxin content, is not liable to cause anaphylases, and can still maintain high stability and a long validity period.

Description

technical field [0001] The invention relates to a freeze-dried protective agent and its application, freeze-dried seedlings and a preparation method thereof, in particular to a gelatin-free freeze-dried protective agent and its application in BCG for treatment, freeze-dried seedlings and preparation of freeze-dried seedlings A seedling method belongs to the field of biological products. Background technique [0002] From the mid-1970s to the 1980s, more and more evidence showed that CIS, one of the early bladder cancer types, could be treated with the immune drug Bacillus Calmette-Guerin (BCG). BCG is an attenuated vaccine that is injected into the bladder through a catheter (called infusion therapy) to generate an immune response to treat the tumor. The results of multiple clinical trials have shown that compared with surgery alone, BCG treatment after endoscopic resection of CIS can reduce the risk of bladder cancer recurrence. Subsequent trial results confirmed that lon...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K47/36A61K47/18A61K47/02A61K9/19A61K39/04A61P35/00
CPCA61K9/19A61K39/04A61K47/02A61K47/183A61K47/26A61K47/36A61P35/00
Inventor 马昭明任昭源陈山岭严秋萍吴盈盈李泳宏陈政钦杨远超王明珠
Owner 成都可恩生物科技有限公司
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