Mercury-free Japanese encephalitis inactivated vaccine composition and application thereof

A technology of inactivated vaccines and compositions, applied in the field of vaccine compositions and Japanese encephalitis vaccine compositions, to achieve the effect of ensuring good health

Inactive Publication Date: 2013-02-13
SHANGHAI RONGSHENG BIOLOGICAL PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But domestic and foreign JE inactivated vaccines such as domestic Japanese encephalitis inactivated vaccine (Chinese Pharmacopoeia three, Beijing: Chemical Industry Press, 2005 edition: 74-76), Japanese encephalitis inactivated vaccine produced in Japan (Instructions for Japanese Encephalitis Inactivated Vaccine produced by BIKEN Osaka University Guanyinji Research Institute) and Taiwan Guoguang Japanese Encephalitis Vaccine (http: / / www.adimmune.com.tw / product.asp?p_id=20051028929351YQ4XR) both contain thimerosal , so far there is no report about the inactivated JE vaccine not containing thimerosal

Method used

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  • Mercury-free Japanese encephalitis inactivated vaccine composition and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The preparation of embodiment 1 mercury-free vaccine

[0035] Take a certain volume of the vaccine stock solution, dilute it 5, 10, 15, and 20 times with the phenol red-free 199 culture medium with a diluent of 2.5% (v / v) 20% human serum albumin, and neutralize it with immunized mice. The titer is determined by antibody assay (the conformity assessment standard is: T≥(RA+RB) / 2—0.33, wherein: T=tested vaccine, RA / RB=reference vaccine). Determine that a certain dilution factor falls within the range of the target titer determination (take the highest dilution factor among all qualified data). The phenol red-free 199 culture solution and the virus protection agent (human serum albumin) were added to the vaccine stock solution according to the dilution factor to obtain the mercury-free JE inactivated vaccine.

[0036] Take the preparation of 10 liters of vaccine liquid as an example, if the dilution factor measured by the qualified experiment is 10 times, in 1 liter of vac...

Embodiment 2

[0042] Example 2 Bacterial inspection of mercury-free vaccines and mercury-containing vaccines

[0043] Prepare the vaccine solution according to the prescription of this preparation, and compare it with the vaccine solution supplemented with 0.01% (v / v) thimerosal and the inactivated Japanese encephalitis vaccine (produced by Beijing Tiantan Biological Company, containing 0.01% thimerosal) in the existing market respectively. Parallel sterility test verification.

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Abstract

The invention discloses a mercury-free Japanese encephalitis inactivated vaccine composition, which consists of inactivated Japanese encephalitis virus, phenol red free 199 culture solution and virus protective agent. Through comparison with fungus inspection of a mercury-containing preparation, the composition can achieve the quality standard required by Chinese Pharmacopoeia on sterile products. In the preparation of a Japanese encephalitis vaccine, thiomersalate is not used so as to avoid the adverse effect caused by mercury pollution on users, and ensures body health of the users.

Description

technical field [0001] The invention relates to a vaccine composition, in particular to a Japanese encephalitis vaccine composition, and more particularly to a mercury-free inactivated Japanese encephalitis vaccine composition. Background technique [0002] Since the Frenchman Pasteur invented vaccines, vaccines have played a pivotal role in the battle against infectious diseases and made important contributions to improving human health and social stability. [0003] The current vaccines are mainly divided into two categories: live attenuated vaccines and inactivated vaccines. Live attenuated vaccines mainly include varicella vaccine, measles and mumps vaccine, hepatitis A vaccine and BCG vaccine, etc. Inactivated vaccines mainly include influenza vaccine, Japanese encephalitis vaccine, rabies vaccine, DPT vaccine, Hib vaccine and meningococcal meningitis vaccine, etc. [0004] In the preparation of inactivated vaccines, the traditional method is to add buffers or excipien...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/12A61K47/42A61P31/12
CPCY02A50/30
Inventor 朱绍荣
Owner SHANGHAI RONGSHENG BIOLOGICAL PHARM CO LTD
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