Novel process for preparing influenza virus split vaccine

Abstract

The invention relates to a novel process for preparing influenza virus split vaccine, comprising the following steps of: (1) inoculating and culturing viruses: inoculating working seed lot viruses diluted to virus amount of 2.0-0.6LgEID50 / ml in chick embryo allantois, and culturing at 33-35 DEG C for 48-72h; (2), harvesting and inactivating viruses and concentrating a virus harvest liquid; (3) purifying and splitting viruses: adding TritonX-100 with volume ratio of final concentration of 0.3-0.5% and deoxysodium cholate in a purified virus liquid, mixing evenly and placing at 20-30 DEG C for 90-120min; (4) adding a PB split agent; and (5) sterilizing, filtering and then preparing a semi-finished product: diluting each stock solution to hemagglutinin content of 30micrograms / strain / ml by 0.01mol / L of PBS (Phosphate Buffered Saline) with a pH value of 7.2, and filtering by a filter membrane with aperture of 0.22micron to obtain a semi-finished product. The novel process for preparing influenza virus split vaccine has the beneficial effects that: due to the increase of a novel purification method, high yield can be achieved, effective antigen content can be improved and the contents of residual ovalbumin and split agent causing inoculation reaction can be greatly reduced.

Description

technical field

[0001] The invention belongs to the field of vaccine preparation, in particular to a new process for preparing influenza virus split vaccine. Background technique

[0002] Influenza is a highly contagious viral disease caused by influenza virus. Influenza viruses are divided into three types: A, B, and C. Among them, type A is the most common cause of disease. Influenza A viruses often mutate within 10 to 15 years, and new subtypes emerge, causing a pandemic. Since the human body has no cross-immunity to various types of influenza viruses, new subtypes of influenza in different ranges are prevalent every year.

[0003] There are three types of vaccines used for influenza prevention in my country: whole virus inactivated vaccine, split vaccine and subunit vaccine. Influenza vaccine contains three virus strains, 2 types A and 1 type B. The active ingredients of these three virus strains have been "killed" during the production process of the vaccine, so vacc...

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