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

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...

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, the stock solution needs to be mixed with concentrated stabilizer ①, stabilizer ②, stabilizer ③ and vaccine solution in sequence. The operation steps are cumbersome and the risk of bacterial contamination is increased.

[0010] (3) There may be spillage of live virus during vaccine injection

[0011] (4) The vaccine injection dose is 1.0ml. Compared with the vaccine of 0.5ml specification, the consumption of auxiliary materials increases, thereby increasing the cost of production

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