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Combined vaccine for hepatitis A, B virus and its preparation method

A hepatitis B and combined vaccine technology, applied in the field of medical biology, can solve the problems of increasing cross-infection, increasing production costs, transportation, storage, use, and children's immunization burden

Inactive Publication Date: 2005-03-23
INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

One can imagine the heavy burden of children's immunization. Not only that, vaccination also increases the chance of cross-infection, and increases production costs and various expenses such as transportation, storage, and use in production. Especially in my country with a large population, medical staff The workload and the resulting economic loss are extremely rare

Method used

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  • Combined vaccine for hepatitis A, B virus and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0141] Prepare the combined vaccine of type A and hepatitis B according to the following process:

[0142] A, earlier human embryonic lung diploid cell line (KMB17) seed batch cell inoculation spinner bottle is cultivated, grows into monolayer to cell, then the P26 generation working seed batch virus seed of hepatitis A virus seed HAV LV-8 strain is passed through After freeze-thawing and ultrasonication, inoculate on human embryonic lung diploid cells (KMB17) at a volume ratio of 1:5, culture at 35°C for 16 days, and harvest the virus liquid. The antigen titer is 1:1024, and the infectious titer is 7.73CID 50 / ml;

[0143] B. Freezing and thawing the above virus liquid, ultrasonic crushing, nuclease digestion, chloroform extraction, PEG concentration, DEAE Sepharose FF chromatography, and inactivation with 1:4000 formaldehyde at 37°C for 12 days to obtain the purified hepatitis A antigen, which The titer is 1:512~1:1024;

[0144]C. Add 0.5mg / ml of Al(OH) to the above-mentio...

Embodiment 2

[0154] Prepare the combined vaccine of type A and hepatitis B according to the following process:

[0155] A. First inoculate the seed batch cells of the human embryonic lung diploid cell line (KMB17) into a spinner bottle for culture until the cells grow into a single layer, and then freeze-thaw the P26 generation virus seeds of the HAV Lv-8 strain Afterwards, inoculate on the human embryonic lung diploid cell (KMB17) according to the volume ratio of 1:10, cultivate at 35 ℃ for 16 days and harvest the virus liquid, its antigen titer is 1:1024, and the infectious titer is 7.73CID50 / ml;

[0156] B. Freezing and thawing the above virus liquid, ultrasonic crushing, nuclease digestion, chloroform extraction, PEG concentration, DEAE Sepharose FF chromatography, inactivation with 1:4000 aldehyde at 37°C for 12 days to obtain the purified hepatitis A antigen, which The titer is 1:512~1:1024;

[0157] C. Add 1.0mg / ml of Al(OH) to the above-mentioned hepatitis A purified antigen 3 Sh...

Embodiment 3

[0167] The preparation method is the same as in Example 1. After mixing according to the following proportions, shake at 20-40°C for 1 hour to obtain a combined vaccine with a hepatitis A antigen content of 640EU / ml and a hepatitis B antigen content of 10ug / ml:

[0168] HAV antigen of Lu 8 strain 640EU / ml

[0169] HBs antigen 10ug / ml

[0170] Aluminum hydroxide 1.0mg / ml

[0171] 2-Phenoxyethanol 5.0mg / ml

[0172] Tween-20 0.05mg / ml

[0173] Glycine 3.0mg / ml

[0174] Sodium Chloride 0.9mg / ml.

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Abstract

A vaccine for preventing both hepatitis A and hepatitis B and its preparing process are disclosed. It has high safety, immunogenicity and stability.

Description

technical field [0001] The invention relates to a combined vaccine of hepatitis A and hepatitis B, and belongs to the field of medical biotechnology. 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, which is prevalent all over the world. Most parts of my country belong to high-endemic areas of hepatitis A, with more than one million cases reported every year, most of which are preschool children. With the development of economy and the improvement of sanitation conditions in recent years, the prevalence of hepatitis A has been characterized by an upward shift in the age of onset, a serious condition, and an increase in fatality rate. Hepatitis B is a worldwide public health problem. my country is a high prevalence area of ​​hepatitis B, with a high carrier rate among the population. There are 120 million carriers of hepatitis B surface antigen, and there...

Claims

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Application Information

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IPC IPC(8): A61K39/29A61K39/295A61P1/16A61P31/12
CPCY02A50/30
Inventor 褚嘉祐张华远陈统球汪恩浩史荔毛群颖黄小琴
Owner INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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