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Combined hepatitis A and B vaccine and preparation method thereof

A hepatitis B and combined vaccine technology, applied in biochemical equipment and methods, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve problems such as complex immunization procedures and increased immunization costs, and achieve good safety and improve immunity. The success rate of inoculation and the effect of reducing the number of inoculations

Inactive Publication Date: 2013-03-27
SHENZHEN KANGTAI BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, as the country expands the immunization program, there are more and more types of vaccines, the number of immunizations is increasing, the immunization procedures are complicated, and the cost of immunization is also increasing, which also increases the chance of missed vaccinations

Method used

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  • Combined hepatitis A and B vaccine and preparation method thereof
  • Combined hepatitis A and B vaccine and preparation method thereof
  • Combined hepatitis A and B vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] This embodiment mainly includes hepatitis A virus antigen and hepatitis B virus surface antigen protein, wherein, the hepatitis A virus antigen is the hepatitis A virus harvested and purified by human embryo lung diploid cell culture Viral antigen, the content of which is 630-660EU / ml. The content of the hepatitis B virus surface antigen protein is the hepatitis B virus surface antigen protein expressed and purified by recombinant Saccharomyces cerevisiae, and the content is 15-30 μg / ml.

[0031] In addition, this embodiment may also include immune aluminum adjuvant, and the content of immune aluminum adjuvant is 0.35-0.62 mg / ml.

Embodiment 2

[0033] This embodiment mainly includes hepatitis A virus antigen and hepatitis B virus surface antigen protein, wherein, the hepatitis A virus antigen is the hepatitis A virus harvested and purified by human embryo lung diploid cell culture Viral antigen, its content is 640EU / ml, the content of the hepatitis B virus surface antigen protein is the recombinant Saccharomyces cerevisiae fermented and expressed and purified hepatitis B virus surface antigen protein, its content is 20μg / ml, the content of immune aluminum adjuvant 0.35 ~ 0.62mg / ml.

[0034] During specific implementation, the hepatitis A virus strain SH strain used in this embodiment is a strain newly isolated by our company with high toxin production, short culture period, and good adaptation to human embryonic lung diploid cells, which can effectively increase the Yield and safety are better; cell-virus mixed adsorption technology is used to greatly increase virus yield, shorten virus culture cycle, and cell factor...

Embodiment 3

[0038] This embodiment mainly includes the following steps:

[0039] The preparation step of the hepatitis A virus antigen is to harvest and purify the hepatitis A virus through human embryonic lung diploid cells to obtain the hepatitis A virus antigen;

[0040] The preparation step of hepatitis B virus surface antigen protein, fermenting and purifying recombinant Saccharomyces cerevisiae, hepatitis B virus surface antigen protein;

[0041] In the mixing step, the hepatitis A virus antigen and the hepatitis B virus surface antigen protein are mixed, and the pH value is adjusted to between 6.0 and 7.0 to prepare a combined hepatitis A and hepatitis B vaccine.

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Abstract

The invention discloses a combined hepatitis A and B vaccine comprising a hepatitis A viral antigen and a hepatitis B virus surface antigen protein, wherein the hepatitis A viral antigen is obtained by carrying out human embryo lung diploid cell culture on hepatitis A viruses, collecting and purifying, and the content of the hepatitis A viral antigen is 630-660EU / ml; and the hepatitis B virus surface antigen protein is obtained by fermenting recombinant liquor-making yeasts, expressing and purifying, and the content of the hepatitis B virus surface antigen protein is 15-30 microgram per milliliter. According to the invention, frequent inoculation times and the opportunity of the leakage of inoculation are reduced, the success rate of inoculation is improved and the cost of inoculation is reduced, and a more effective way is provided to control the infection and prevalence of hepatitis A and B. The combined hepatitis A and B vaccine is good in security, immunogenicity and stability.

Description

technical field [0001] The invention relates to the field of hepatitis vaccines, in particular to a combined hepatitis A and hepatitis B vaccine and a preparation method thereof. Background technique [0002] Viral hepatitis is a systemic acute or persistent infectious disease mainly caused by liver damage caused by a variety of hepatitis viruses, and it is prevalent all over the world. 30-50% of hepatitis patients belong to hepatitis A (referred to as hepatitis A). Hepatitis A is a self-limiting disease, but it can easily cause outbreaks and is closely related to the local social, economic and health conditions. About 1.4 million cases of hepatitis A are reported in the world every year. In fact, this value may be 3-10 times higher; and hepatitis B (hepatitis B for short) has infected more than 1 / 3 of the world's population. Hepatitis B is a disease caused by hepatitis B virus, which is prevalent in all countries in the world, and my country is a high-endemic area. WHO e...

Claims

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Application Information

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IPC IPC(8): A61K39/29A61P31/14A61P31/20C12N7/00
CPCY02A50/30
Inventor 黄秋香张现臣魏文进曾滢甘建辉李思勤刘雨王春雨钟汉斌孟红彦黎武军
Owner SHENZHEN KANGTAI BIOLOGICAL PROD
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