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Quadrivalent influenza virus subunit vaccine and preparation method thereof

A subunit vaccine and influenza virus technology, applied in the field of quadrivalent influenza virus subunit vaccine and preparation thereof, can solve problems such as intractable induration itching, and achieve the effects of easy process, reduced redness and high production efficiency

Inactive Publication Date: 2018-01-05
ZHONGYI ANKE BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is also reported that the use of DPT vaccine adsorbed on aluminum hydroxide produced by the Statens Serum Institute in Denmark resulted in 546 serious adverse reactions of intractable itching at the injection site.

Method used

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  • Quadrivalent influenza virus subunit vaccine and preparation method thereof

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Embodiment 1

[0030] A 1 (H1N1) type influenza virus subunit vaccine monovalent stock solution production method, including the following steps in sequence:

[0031] (1). Virus inoculation: inoculate the working seeds of A1 (H1N1) influenza virus in the allantoic cavity of 10-day-old healthy chicken embryos;

[0032] (2). Virus propagation culture: transfer the inoculated chicken embryos to a 34°C incubator for 48 hours to propagate influenza virus;

[0033] (3). Harvesting of allantoic fluid: screen live chicken embryos, place the embryos at 2-8°C for 16 hours, and then harvest the allantoic fluid;

[0034] (4). Clarification: remove most impurities such as chicken embryo red blood cells by centrifugation.

[0035] (5). Inactivation: add formaldehyde with a final concentration not higher than 200mg / ml to the monovalent virus harvest solution, and inactivate at 2-8°C for 80 hours;

[0036] (6). Ultrafiltration concentration: the influenza virus allantoic harvest liquid after fully inactiv...

Embodiment 2

[0040] A 3 (H3N2) type influenza virus subunit vaccine monovalent stock solution production method, including the following steps in sequence:

[0041] (1). Virus inoculation: Inoculate the working seeds of A3 (H3N2) influenza virus into the allantoic cavity of 10-day-old healthy chicken embryos;

[0042] (2). Virus propagation culture: transfer the inoculated chicken embryos to a 34°C incubator for 48 hours to propagate influenza virus;

[0043] (3). Harvesting of allantoic fluid: screen live chicken embryos, place the embryos at 2-8°C for 16 hours, and then harvest the allantoic fluid;

[0044] (4). Clarification: remove most impurities such as chicken embryo red blood cells by centrifugation.

[0045] (5). Inactivation: add formaldehyde with a final concentration not higher than 200mg / ml to the monovalent virus harvest solution, and inactivate at 2~8°C for 100 hours;

[0046] (6).Ultrafiltration and concentration: the fully inactivated influenza virus allantoic harvest liqu...

Embodiment 3

[0050] The method for producing monovalent stock solution of type B (B) influenza virus subunit vaccine comprises the following steps in sequence:

[0051] (1). Virus inoculation: inoculate the working seeds of type B (B) influenza virus in the allantoic cavity of 10-day-old healthy chicken embryos;

[0052] (2). Virus propagation culture: transfer the inoculated chicken embryos to a 34°C incubator for 72 hours to propagate influenza virus;

[0053] (3). Harvesting of allantoic fluid: screen live chicken embryos, place the embryos at 2-8°C for 16 hours, and then harvest the allantoic fluid;

[0054] (4). Clarification: remove most impurities such as chicken embryo red blood cells by centrifugation.

[0055] (5). Inactivation: add formaldehyde with a final concentration of not higher than 200 mg / ml to the monovalent virus harvest liquid or ultrafiltration concentrated liquid, and inactivate at 2-8°C for 120 hours;

[0056] (6). Ultrafiltration concentration: the influenza vir...

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Abstract

The invention discloses a quadrivalent influenza virus subunit vaccine and a preparation method thereof, wherein virus protein after lysis is further purified by using a lysis agent and a new purification method to prepare the tetravalent influenza virus subunit vaccine, the content of four influenza hemagglutinins such as influenza A virus H1N1, influenza A virus H3N2 and two kinds of influenza Bviruses in each dose of the vaccine is more than 80%, and the quadrivalent influenza virus subunit vaccine does not contain adjuvant and does not contain thimerosal and other preservatives. The invention further provides a preparation method of the quadrivalent influenza virus subunit vaccine, wherein the preparation method comprises: virus inoculation, virus proliferation culture, allantoic fluid harvesting, clarification, ultra-filtration concentration, inactivation, lysis and ultracentrifugation purification, gel filtration chromatography purification (ultra-filtration), blending, filtration sterilization, sub-packaging, packaging and other steps. According to the present invention, the quadrivalent influenza virus subunit vaccine can improve the safety of the influenza vaccine, can eliminate the adverse reaction caused by the adjuvant, and can eliminate the toxic-side effects caused by thimerosal.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a quadrivalent influenza virus subunit vaccine and a preparation method thereof. Background technique [0002] Influenza is caused by influenza virus, which can cause large-scale epidemics of acute respiratory diseases transmitted by humans and animals. Influenza viruses are divided into three types: A, B, and C. Among them, type A has the strongest pathogenicity and can infect animals and humans and cause epidemics and even worldwide pandemics; type B is less pathogenic and can cause local epidemics. Influenza viruses often undergo antigenic drift and antigenic shift, evading the defenses of the body's immune system, which is also the cause of the pandemic. Influenza viruses are highly contagious and spread through the air through droplets. After a short incubation period, high fever and chills develop rapidly, and the body temperature can reach as high as 40°C within...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/295A61K39/145A61K47/10A61P31/16C12N7/00
Inventor 高辉
Owner ZHONGYI ANKE BIOTECH CO LTD
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