Improved lyophilized live attenuated hepatitis a vaccine stabilizer, vaccine finished product, vaccine semi-finished product and preparation method of vaccine finished product and vaccine semi-finished product

A technology for attenuated live vaccines and hepatitis A, applied in biochemical equipment and methods, antiviral agents, freeze-dried transportation, etc., can solve the problems of slow product dissolution, increased production costs, and increased dosage of excipients, and achieve prevention Effects of spillover of live virus, reduction of production costs, and increase in drug use

Active Publication Date: 2019-12-20
长春生物制品研究所有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 1. Vitamin C, dextran 40, and sorbitol are added to the vaccine as one of the stabilizer components. There are too many types of excipients used in the current stabilizer, and when the concentration of these three excipients in the vaccine is too high, the product dissolves slowly , may also cause potential allergic reactions in the body, and excessive use of excipients will also increase production costs;
[0006] 2. In the preparation stage of semi-finished products,

Method used

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  • Improved lyophilized live attenuated hepatitis a vaccine stabilizer, vaccine finished product, vaccine semi-finished product and preparation method of vaccine finished product and vaccine semi-finished product

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preparation example Construction

[0052]The preparation method of the finished product of the improved freeze-dried hepatitis A attenuated vaccine provided by the invention mainly comprises the following steps:

[0053] Step 1. After the hepatitis A virus harvest liquid is prepared by the attenuated strain of hepatitis A virus seed L-A-1 with the preservation number of CCTCC No.V92004, the virus harvest is subjected to cell disruption and purification after extraction to obtain a vaccine stock solution.

[0054] Step 2, prepare the vaccine stabilizer, formula and concentration (final concentration is the mass volume fraction, g / mL) are as follows (the concentration of its components is 2 times of the corresponding improved stabilizer component concentration): Trehalose: 4% -12%, Monosodium Glutamate: 0.2%-2.0%, Arginine: 0.1%-0.6%, Urea: 0.2%-1.6%, Vitamin C: 0%-1.0%, Dextran 40: 0%-4.0% , sorbitol: 0%-1.0%, mannitol: 0.1%-1.0%; weigh the drug according to the above formula, dissolve it in water for injection...

Embodiment 1～12

[0071] According to the prior art, 3 batches of vaccine stocks with the same conditions were prepared as experimental groups for parallel experiments, namely: the 1st batch, the 2nd batch, and the 3rd batch; Store after preparation.

[0072] Prepare 4 batches of stabilizers as the experimental group of parallel experiments, the first batch of vaccine stabilizer: dextran 40 concentration 7.0%, vitamin C concentration 1.0%, sorbitol concentration 1.0%; the second batch of vaccine stabilizer: dextran 40 concentration 4.0%, vitamin C concentration 0.5%, sorbitol concentration 0.5%; the 2nd batch vaccine stabilizer: dextran 40 concentration 2.0%, vitamin C concentration 0.1%, sorbitol concentration 0.1%); the 4th batch vaccine stabilizer: The concentration of dextran 40 is 0.0%, the concentration of vitamin C is 0.0%, and the concentration of sorbitol is 0.0%); it is prepared by the vaccine second room of Changchun Institute of Biological Products Co., Ltd.

[0073] Preparation of...

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Abstract

The invention discloses an improved lyophilized live attenuated hepatitis a vaccine stabilizer. The stabilizer comprises the following components: in percent, 2-6% of trehalose, 0.1-1.0% of sodium glutamate, 0.05-0.3% of Arginine, 0.1-0.8% of urea, 0-0.5% of vitamin C, 40:0-2.0% of dextran, 0-0.5% of sorbitol, 0.05-0.5% of mannitol and the balance water for injection. According to the stabilizer for the improved lyophilized live attenuated hepatitis a vaccine, the chemicals in the stabilizer are reduced, so that the dissolution rate of the stabilizer is increased, and the potential allergic reactions of the body are reduced. The invention also provides a preparation method of an improved lyophilized live attenuated hepatitis a vaccine finished product. The improved stabilizer is applied topreparation of the finished product from a semi-finished product, the operation steps be simplified, the cost of the materials is reduced, the risk of bacteria infection is reduced, and the product quality is improved.

Description

technical field [0001] The invention relates to a freeze-dried live attenuated hepatitis A vaccine, in particular to an improved freeze-dried live attenuated hepatitis A vaccine stabilizer and a preparation method for the finished product. Background technique [0002] All freeze-dried live attenuated hepatitis A vaccines contain a certain amount of stabilizers, whose function is to keep the activity of the target protein in the freeze-dried product, and to ensure that the freeze-dried product is uniform, smooth and stable, of which vitamin C and dextran 40 1. Sorbitol, as one of the stabilizer components, is added to the vaccine to play the role of excipient and scaffold. [0003] At present, the vaccine stabilizers used in the freeze-dried live attenuated hepatitis A vaccine used by our company are: the final concentration of trehalose is 2%-6%, the final concentration of sodium glutamate is 0.1%-1.0%, arginine The final concentration of acid is 0.05%-0.3%, the final conc...

Claims

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Application Information

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IPC IPC(8): A61K47/36A61K47/18A61K47/22A61K47/26A61K9/19A61K39/29A61P1/16A61P31/14
CPCA61K47/36A61K47/183A61K47/18A61K47/22A61K47/26A61K9/19A61K39/12A61P1/16A61P31/14A61K2039/5254A61K2039/54C12N2770/32434Y02A50/30
Inventor 徐艳玲刘令九侯丽娟王艺博顾建阳周延彬杨利民李育红鞠闯
Owner 长春生物制品研究所有限责任公司
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