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A vaccine lyoprotectant without gelatin and human albumin

A freeze-dried protective agent and vaccine technology, which is applied in the direction of freeze-dried transportation, medical preparations containing active ingredients, antiviral agents, etc., can solve problems such as prone to failure, decreased vaccine stability, and unsatisfactory vaccine protection effect. Achieve the effect of improving safety and reducing adverse reactions

Active Publication Date: 2019-05-03
SINOVAC DALIAN VACCINE TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although the protective agent that does not contain gelatin and human serum albumin in the prior art reduces the irritation to the human body, the protective effect on the vaccine is not ideal, which makes the stability of the vaccine decrease during the freeze-drying process and during storage. , prone to failure

Method used

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  • A vaccine lyoprotectant without gelatin and human albumin
  • A vaccine lyoprotectant without gelatin and human albumin
  • A vaccine lyoprotectant without gelatin and human albumin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Take a single harvest liquid of live attenuated varicella vaccine, add a freeze-drying protective agent to remove cell fragments, and obtain a stock solution of live attenuated varicella vaccine. The matrix solution of the protective agent is PBS buffer solution, and the final concentration of the protective agent in the stock solution of the live attenuated varicella vaccine is 1.5% sucrose, 3.5% dextran 70, 2% sorbitol, 0.8% sodium glutamate, 1% L-arginine acid.

[0032] (2) Add appropriate amount of diluent (containing 1.5% sucrose, 3.5% dextran 70, 2% sorbitol, 0.8% sodium glutamate, 1% L-arginine) formulated into vaccine semi-finished products. The vaccine semi-finished product contains the following final concentration components: 1.5% sucrose, 3.5% dextran 70, 2% sorbitol, 0.8% sodium glutamate, and 1% L-arginine.

[0033] (3) The semi-finished product of the vaccine is divided into vials and freeze-dried to obtain the finished product of live attenuated va...

Embodiment 2

[0035] A single harvest liquid of live attenuated varicella vaccine is taken, and a protective agent is added to remove cell fragments to obtain stock solution of live attenuated varicella vaccine. The matrix solution of the protective agent is water for injection, and the final concentration of the protective agent in the stock solution of the live attenuated varicella vaccine is 5% sucrose, 3% dextran 70, 1% sorbitol, 1% sodium glutamate, 0.2% L-arginine acid.

[0036] Add appropriate amount of diluent (containing 5% sucrose, 3% dextran 70, 1% sorbitol, 1% sodium glutamate, 0.2% L-arginine) to the stock solution of varicella live attenuated vaccine according to the virus titer of 4.8lg PFU / ml ) formulated into vaccine semi-finished products. The vaccine semi-finished product contains the following final concentration components: 5% sucrose, 3% dextran 70, 1% sorbitol, 1% sodium glutamate, 0.2% L-arginine.

[0037] The semi-finished product of the vaccine is divided into vi...

Embodiment 3

[0039] (1) Take a single harvest liquid of live attenuated varicella vaccine, add a protective agent to remove cell fragments, and obtain the stock solution of live attenuated varicella vaccine. The matrix solution of the protective agent is 199 culture solution, and the final concentration of the protective agent in the stock solution of the live attenuated varicella vaccine is 10% sucrose, 1.5% dextran 70, 2% sorbitol, 1.2% sodium glutamate, 0.5% L-alcohol acid. The manufacturer of 199 culture medium is GIBCO.

[0040] (2) Add appropriate amount of diluent (containing 10% sucrose, 1.5% dextran 70, 2% sorbitol, 1.2% sodium glutamate, 0.5% L- arginine) formulated into vaccine semi-finished products. The vaccine semi-finished product contains the following final concentration components: 10% sucrose, 1.5% dextran 70, 2% sorbitol, 1.2% sodium glutamate, 0.5% L-arginine.

[0041] (3) The semi-finished product of the vaccine is divided into vials, and freeze-dried with referenc...

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Abstract

The present invention relates to the field of biological products, and in particular relates to a vaccine freeze-drying protective agent containing no gelatin and human albumin. The vaccine freeze-drying protective agent comprises 1.5%-10% of sucrose, 1.5%-3.5% of dextran, 1%-2% of sorbitol, 0.8%-1.2% of sodium glutamate and 0.2% to 1% of L-arginine in a vaccine semi-finished product, a matrix liquid for preparation of the vaccine freeze-drying protective agent is 199 culture medium or PBS buffer solution or water for injection, the vaccine freeze-drying protective agent contains no gelatin and human albumin, and the vaccine semi-finished product is a liquid vaccine before freeze-drying. The present invention also provides the use of the vaccine freeze-drying protective agent. When the vaccine freeze-drying protective agent is used for the preparation of a freeze-dried vaccine, the vaccine freeze-drying protective agent can improve the vaccine stability during freeze-drying and storage processes, greatly improves the freeze-dried vaccine safety for human, and reduces adverse effects of the vaccine.

Description

technical field [0001] The invention relates to the field of biological products, in particular to a formulation and application method of a vaccine protective agent free of gelatin and human serum albumin. Background technique [0002] Vaccination is an effective means of preventing epidemic viruses and can reduce the morbidity and mortality of infectious diseases. With the wide application of vaccines and the rapid development of molecular biology and cell biology, studies have found that many adverse reactions after vaccination are directly related to the protective agents of vaccine products, especially the freeze-dried vaccine products. Protective agent, wherein gelatin or gelatin derivatives can directly cause allergic reactions such as allergy to the inoculated person. In order to reduce or avoid adverse reactions caused by gelatin during vaccine use, experts suggest using gelatin substitutes or directly producing vaccine products without gelatin (Chen Tian, ​​Gelati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/26A61K47/18A61K47/22A61K39/25A61K9/19A61P31/22
Inventor 孟凡红栾春芳何玉君张嵬杨利伟杨玉国
Owner SINOVAC DALIAN VACCINE TECH
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