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Diploid-cell rabies vaccine and purified rabies vaccine, freeze-drying preparation and water injection thereof

A technology of diploid cell and rabies vaccine, applied in the field of rabies purified vaccine, can solve the problem that exogenous factors cannot guarantee, cannot guarantee tumorigenicity of cell matrix and cell DNA, cannot guarantee that cells do not carry, etc., and achieve good antibody level , the effect of improving stability and increasing durability

Inactive Publication Date: 2005-12-28
崔栋
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0002] At present, there are four kinds of rabies vaccines mass-produced in the world: the first kind is diploid cells represented by the United States, which is prepared by concentration and ultracentrifugation; Dry inactivated vaccine, but does not guarantee tumorigenicity of the cell matrix and cellular DNA
The third and fourth types of vaccines are hamster kidneys represented by China and chicken embryos and duck embryos from Japan. The cells of these types of vaccines are derived from common animals. It cannot be guaranteed that the cells do not carry foreign factors and the tumorigenicity and tumorigenicity of the cell matrix cannot be guaranteed. cell DNA
However, vaccines prepared with Vero cells must be used at low cell generations to ensure no tumorigenicity, and the amount of residual cell DNA must be less than 100pg / dose

Method used

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  • Diploid-cell rabies vaccine and purified rabies vaccine, freeze-drying preparation and water injection thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Diploid cells come from the Chinese Center for Disease Control and Prevention, and the cell nutrient solution is 199 medium containing 2-10% bovine serum, 25IU / ml gentamycin and 25IU / ml kanamycin, and adjust the pH to 7.2 with The 3L spinner bottle was cultured at 37°C to form a dense monolayer and then amplified according to the seeding ratio of 1:2. When it was expanded to the production batch, after about 4 days, when the cells grew into a dense monolayer, the cell nutrient solution was discarded, and the pH7. Wash the cell surface with 2 Earl's solution, inoculate the diploid cell rabies virus, use the second generation working virus of the rabies virus SNK-CTN strain passed on the diploid cells, the concentration of the virus is MOI0.05, and the cell maintenance solution is 199 culture medium containing 0.4-0.5% (W / W) human serum albumin, pH 7.6, cultivate at 35°C, replace with fresh cell maintenance medium after 24 hours and continue to culture for 2 days, start to...

Embodiment 2

[0059] Diploid cells come from the Chinese Center for Disease Control and Prevention, and the cell nutrient solution is 199 medium containing 2-10% bovine serum, 25IU / ml gentamycin and 25IU / ml kanamycin, and adjust the pH to 7.2 with After cultured in a 3L spinner bottle at 37°C to form a dense monolayer, amplify according to the seeding ratio of 1:2. When the expansion reaches the production batch, after about 4 days, when the cells grow into a dense monolayer, the cell nutrient solution is discarded, and the pH7. Wash the cell surface with 2 Earl's solution, inoculate the diploid cell rabies virus, use the second generation working virus of the rabies virus SNK-CTN strain passed on the diploid cells, the concentration of the virus is MOI0.05, and the cell maintenance solution is 199 culture medium containing 0.4-0.5% (W / W) human albumin, pH 7.6, cultivate at 35°C, replace with fresh cell maintenance medium after 24 hours and continue to culture for 2 days, start to harvest vi...

Embodiment 3

[0063] With the inactivated rabies vaccine prepared by the method of claim 1, after 14 days of inoculating the purified rabies vaccine to those who have not been vaccinated against rabies, the positive conversion rate of neutralizing antibodies is higher than 95.0%, and no side effects occur.

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Abstract

A purified diplontic cell vaccine in the form of freeze-dried powder injection or liquid injection for rabies is prepared through inoculating rabies virus into human diploied cells.

Description

Technical field: [0001] The invention relates to a purified rabies vaccine, in particular to a purified rabies vaccine obtained by inoculating human diploid cells with rabies virus seeds. Background technique: [0002] At present, there are four kinds of rabies vaccines mass-produced in the world: the first kind is diploid cells represented by the United States, which is prepared by concentration and ultracentrifugation; Dry inactivated vaccines, but can not guarantee the tumorigenicity of the cell matrix and the DNA of the cells. The third and fourth types of vaccines are hamster kidneys represented by China and chicken embryos and duck embryos from Japan. The cells of these types of vaccines are derived from ordinary animals. It cannot be guaranteed that the cells do not carry exogenous factors, nor can the tumorigenicity and tumorigenicity of the cell matrix. the DNA of the cell. [0003] Human Diploid Cellular Vaccine (HDCV): [0004] In 1964, Wiktor described HDCV fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/205
Inventor 崔栋
Owner 崔栋
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