Preparation of tetravalent wheel shaped virus inactivated vaccine and application

A technology of rotavirus and inactivated vaccine, applied in the direction of antiviral agent, virus antigen component, etc., can solve the problem of preparation that has not been reported.

Active Publication Date: 2005-10-26
LANZHOU INST OF BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no report about the preparation of quadrivalent rotavirus inactivated vaccine

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment one: a kind of preparation method of quadrivalent rotavirus inactivated vaccine comprises the following process steps:

[0016] 1. Preparation of cells

[0017] The source of calf kidney cells (newborn calf kidney cells) is healthy newborn calves. Cattle should meet the requirements of the "Animal Epidemic Prevention Law of the People's Republic of China". Cell preparation and assay procedure ") Digest and disperse with trypsin, add D-MEM complete culture medium and culture at 37°C until the cells form a sheet, then wash the cells with serum-free D-MEM culture medium 3 times for rotavirus inoculation .

[0018] 2. Virus inoculation and cultivation: G1, G2, G3, and G4 rotavirus seeds (the virus was tested by rotavirus G serotype, rotavirus genome nucleic acid electrophoresis test, rotavirus VP7 gene nucleoside Acid sequence determination, virus titration, sterility inspection, virus exogenous factor inspection, immunogenicity inspection, all phase inspection...

Embodiment 2

[0028] Embodiment two, a kind of preparation method of quadrivalent rotavirus inactivated vaccine comprises the following process steps:

[0029] 1. Preparation of cells

[0030] Digest and disperse Vero cells with trypsin, add D-MEM complete culture medium and culture at 37°C until the cells form a sheet, then wash the cells 3 times with serum-free D-MEM culture medium for rotavirus inoculation.

[0031] All the other processing steps are identical with embodiment one.

[0032] Vaccine testing

[0033] 1. Raw solution test

[0034] Each monovalent vaccine stock solution of the present invention is qualified through the verification of sterility test, virus titration, inactivation test, bovine serum albumin residue and total protein content.

[0035] 2. Inspection of finished products

[0036] The finished product of the tetravalent rotavirus inactivated vaccine of the present invention is completely qualified through identification test, appearance, pH value, thimerosal c...

Embodiment 3

[0037] Example 3. Immunogenicity experiment: BALB / C mice, weighing 14-16 grams, blood was collected from the tail vein before immunization, and the serum was separated and frozen at -20°C. Mice were inoculated with quadrivalent rotavirus inactivated vaccine by intramuscular injection, blood was collected 4 weeks later, serum was separated, and the neutralizing antibody titer of mouse serum before and after immunization was determined by neutralization test. After immunization, the antibody positive conversion rate of mice is 96-100% (the antibody positive conversion is defined as an increase of more than 4 times after immunization.)

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PUM

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Abstract

A deactivated tetravalent rotavirus vaccine for preventing the infantile rotavirus infections diseases is prepared from the calf kidney cells digested and dispersed by pancreatin or cultured Vero cells through inoculating rotaviruses G1, G2, G3 and G4, culturing in non-serum culture liquid D-MEM, concentrating, purifying, deactivating, mixing and adding aluminium hydroxide.

Description

technical field [0001] The invention belongs to a biological product and relates to the preparation and application testing of a virus inactivated vaccine, in particular to the preparation and application of a quadrivalent rotavirus inactivated vaccine. Background technique [0002] Rotaviruses are double-stranded RNA viruses belonging to the family Enteroviridae, and their coat proteins are type-specific antigens. According to their antigenicity, rotaviruses are divided into two groups, A and B, among which group A mainly causes human diarrhea. Group A rotaviruses are divided into 14 serotypes according to the difference of coat protein VP7, that is, G1-G14 types, while G1, G2, G3, and G4 rotaviruses mainly cause diarrhea in infants and young children. At present, there is no report on the preparation of the quadrivalent rotavirus inactivated vaccine. Contents of the invention [0003] The purpose of the present invention is to provide a preparation of a quadrivalent rot...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/15
Inventor 周旭
Owner LANZHOU INST OF BIOLOGICAL PROD
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