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Meningitis vaccine and preparation method thereof

A technology for vaccines and meningitis, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, bacterial antigen components, etc., and can solve problems such as fever reactions

Active Publication Date: 2014-04-16
华兰生物疫苗股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the existing bacterial endotoxin pharmacopoeia standards for meningitis polysaccharide vaccines, most people will only have a very mild fever reaction after being vaccinated, but a few people will have a severe fever reaction as a result.

Method used

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  • Meningitis vaccine and preparation method thereof
  • Meningitis vaccine and preparation method thereof
  • Meningitis vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Embodiment 1, prepare meningitis vaccine I

[0063] 1. Separately ferment Neisseria meningitidis group A, Neisseria meningitidis group C, Neisseria meningitidis group Y and Neisseria meningitidis group W135

[0064] (1) Production strain preparation

[0065] The first generation: open the batch of working seed strains, inoculate on 10% sheep blood ordinary agar medium, and culture at 37°C and 8% carbon dioxide environment for 18 hours.

[0066] Second-generation and third-generation culture: Inoculate the first-generation strains into semi-comprehensive meningitis medium and incubate at 37°C for 12 hours; inoculate the second-generation strains into semi-comprehensive meningitis medium and culture at 37°C for 12 hours .

[0067] (2) The fourth generation (strain tank) culture

[0068] The third-generation strains were divided into 5×10 8 The concentration of / ml was inoculated in the strain jar that the ECM semi-comprehensive liquid medium was housed, and cultivated...

Embodiment 2

[0105] Embodiment 2, preparation meningitis vaccine II

[0106] 1. Separately ferment Neisseria meningitidis group A, Neisseria meningitidis group C, Neisseria meningitidis group Y and Neisseria meningitidis group W135

[0107] (1) Production strain preparation

[0108] The first generation: open the batch of working seed strains, inoculate on 10% sheep blood ordinary agar medium, and culture at 37°C and 8% carbon dioxide environment for 18 hours.

[0109] Second-generation and third-generation culture: Inoculate the first-generation strains into semi-comprehensive meningitis medium and incubate at 37°C for 12 hours; inoculate the second-generation strains into semi-comprehensive meningitis medium and culture at 37°C for 12 hours .

[0110] (2) The fourth generation (strain tank) culture

[0111] The third-generation strains were divided into 5×10 8 The concentration of / ml was inoculated in a strain tank equipped with ECM semi-comprehensive liquid medium, and cultivated f...

Embodiment 3

[0148] Embodiment 3, preparation meningitis vaccine III

[0149] 1. Separately ferment Neisseria meningitidis group A, Neisseria meningitidis group C, Neisseria meningitidis group Y and Neisseria meningitidis group W135

[0150] (1) Production strain preparation

[0151] The first generation: open the batch of working seed strains, inoculate on 10% sheep blood ordinary agar medium, and culture at 37°C and 8% carbon dioxide environment for 18 hours.

[0152] Second-generation and third-generation culture: Inoculate the first-generation strains into semi-comprehensive meningitis medium and incubate at 37°C for 12 hours; inoculate the second-generation strains into semi-comprehensive meningitis medium and culture at 37°C for 12 hours .

[0153] (2) The fourth generation (strain tank) culture

[0154] The third-generation strains were divided into 5×10 8 The concentration of / ml was inoculated in the strain jar that the ECM semi-comprehensive liquid culture medium was housed, ...

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Abstract

The invention discloses a meningitis vaccine and a preparation method thereof. The meningitis vaccine consists of polysaccharide obtained by fermenting A Neisseria meningitidis, polysaccharide obtained by fermenting C Neisseria meningitidis, polysaccharide obtained by fermenting Y Neisseria meningitidis, polysaccharide obtained by fermenting W135 Neisseria meningitidis, lactose and water. Experiments prove that the endotoxin content of the polysaccharide prepared by the method disclosed by the invention is very low and is 1 EU / mu g; the endotoxin content of the vaccine prepared by the polysaccharide is very low and is 1 EU / mu g. The vaccine disclosed by the invention is safe and effective; adverse reactions are smaller after the vaccine is inoculated; the vaccine can be accepted by receivers easily and is favorable to the popularization of national immunization policies.

Description

technical field [0001] The invention relates to a tetravalent meningococcal polysaccharide vaccine and its preparation method and process. Background technique [0002] Meningococcal meningitis is a respiratory infectious disease caused by meninges or meninges infected by Neisseria meningitidis. The main clinical manifestations are high fever, headache, projectile vomiting, and stiff neck. It can also cause sepsis, purple congestion and ecchymosis on the skin, and meningitis can cause brain damage and leave sequelae such as hearing loss, deafness, and mental retardation. The fatality rate is between 5% and 10%. The incidence of meningococcal meningitis is high in winter and spring. Generally, the number of cases begins to increase from November to December, and the peak period is from February to May of the next year. The disease has a high incidence rate and a high risk, and is an infectious disease that seriously endangers the health of children. Meningococcal meningiti...

Claims

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Application Information

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IPC IPC(8): A61K39/116A61P31/04A61K39/095
Inventor 崔晓峰马小伟许项可潘若文安文琪范蓓
Owner 华兰生物疫苗股份有限公司
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