Method for preparing seasonal influenza virus split vaccine
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A seasonal influenza and virus technology, applied in the field of H1N1: IVR-148, can solve the problems of limitation, low immunogenicity and protection rate, and achieve low cost, good concentration efficiency and recovery rate, and the effect of protecting antigens
Inactive Publication Date: 2012-04-11
CHENGDU KANGHUA BIOLOGICAL PROD
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Problems solved by technology
During the development of influenza vaccines in the past, many scientific researchers turned to genetically engineered vaccines such as recombinant vaccines, peptide vaccines, and nucleic acid vaccines. However, the low immunogenicity and protection rate of this vaccine limited its application.
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Embodiment 1
[0074] (1) Selection of strains: H1N1 type: IVR-148; H3N2 type: NYMC X-175C; B type: B / Florida / 412006 influenza virus strain, from the British National Institute of Biological Products.
[0075] (2) Identification of poisonous species:
[0076] a) Materials: ① Passage the bacteria in chicken embryos for the second generation (P2). ② Serum: Avian influenza virus H1N1 type: IVR-148; H3N2 type: NYMC X-175C; B type: B / Florida / 412006 influenza virus strain, from the British National Institute of Biological Products.
[0077] b) Method:
[0078] ① Hemagglutination inhibition test and one-way immunodiffusion test: according to the conventional method.
[0079] ②Determination of virus titer: According to the conventional chicken embryo infection method, 4 chicken embryos were inoculated for each dilution.
[0080] ③ Sterility test and exogenous factor inspection: determined according to the requirements of the current version of "Chinese Pharmacopoeia".
[0081] ④ Determination of...
Embodiment 2
[0112] (1) Selection of strains: H1N1 type: IVR-148; H3N2 type: NYMC X-175C; B type: B / Florida / 412006 influenza virus strain, from the British National Institute of Biological Products.
[0113] (2) Identification of poisonous species: a) Materials: ① will be passed to the second generation (P2) in chicken embryos. ② Serum: H1N1 type: IVR-148; H3N2 type: NYMC X-175C; B type: B / Florida / 412006 influenza virus strain, from the British National Institute of Biological Products.
[0114] b) method:
[0115] ① Hemagglutination inhibition test and one-way immunodiffusion test: according to the conventional method.
[0116] ②Determination of virus titer: According to the conventional chicken embryo infection method, 4 chicken embryos were inoculated for each dilution.
[0117] ③ Sterility test and exogenous factor inspection: determined according to the requirements of the current version of "Chinese Pharmacopoeia".
[0118] ④ Determination of the immunogenicity of the virus specie...
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Abstract
The invention provides a method for preparing a seasonal influenza virus split vaccine and a vaccine prepared by using the method, belonging to the technical field of vaccine preparation processes. The preparation method comprises the following steps of: preparing an original liquid from influenza A1, A3 and B virus strain verified as WHO (World Health Organization) recommended virus strain or similar strain through the procedures of working seed bank creation through subculture, chick embryo inoculation, virus liquid culture and harvesting, virus inactivation, ultrafilter concentration, gradient centrifugation, ultrafilter sugar removal, column chromatography, virus splitting, secondary purification and filtration sterilization; and carrying out semi-finished product configuration and finished product packaging to obtain the seasonal influenza virus split vaccine. Because gradient centrifugation purification and molecular sieve chromatography column purification are combined and secondary purification including gradient centrifugation purification after virus splitting is carried out, the method provided by the invention has the advantages of good concentration efficiency and recovery rate, low cost, high efficiency and easiness for operation. The finally prepared product has low impurity content and high HA content, and the standards of endotoxin and ovalbumin are far better than the requirements of Chinese Pharmacopoeia 2010 and European Pharmacopoeia. Moreover, the product provided by the invention does not contain thiomersal, inoculation is safer, and inoculated population is larger.
Description
Technical field: [0001] The invention belongs to the field of biological vaccine preparation, and relates to the preparation of H1N1 type: IVR-148; H3N2 type: NYMC X-175C; B type: B / Florida / 412006 influenza virus strain, which is proved to be a virus strain recommended by WHO or a similar strain through verification. A new process for an influenza virus split vaccine for the prevention of seasonal influenza. Background technique: [0002] Influenza (abbreviated as influenza) is an acute respiratory infectious disease caused by influenza virus. It is mainly transmitted to susceptible persons in the form of aerosols through virus-containing droplets from infected persons. It is highly contagious and likely to cause large-scale epidemics. [0003] Since the last century, four global influenza pandemics have occurred successively. Influenza pandemics have the characteristics of high morbidity and mortality, rapid spread and wide spread. The 1918 "Spanish" flu pandemic alone kil...
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