Testing method of in vitro relative efficiency of inactivated hepatitis A vaccine

An inactivated vaccine, hepatitis A technology, applied in the biological field, can solve the problems of reducing the verification cost and labor intensity, prolonging the validity period of the vaccine, reducing the vaccine inventory, etc. and repetitive effects

Active Publication Date: 2013-03-13
INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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Problems solved by technology

[0004] The purpose of the present invention is to provide a method for testing the relative effectiveness of hepatitis A inactivated vaccine in vitro, to replace the traditional in vivo relative efficacy test in mice, and to solve the problems of many influencing factors, poor repeatability, and long testing period brought by the tested animals. Unfavorable factors of more than 30 days reduce vaccine inventory, prolong the validity period of vaccines, and reduce testing costs and labor intensity

Method used

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  • Testing method of in vitro relative efficiency of inactivated hepatitis A vaccine
  • Testing method of in vitro relative efficiency of inactivated hepatitis A vaccine
  • Testing method of in vitro relative efficiency of inactivated hepatitis A vaccine

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Experimental program
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Effect test

Embodiment 1

[0036] The reference substance S used in the efficacy test of hepatitis A inactivated vaccine is a qualified product produced by the applicant in strict accordance with national standards, and has reached the standard in chemical and biological tests, and its potency Ps is 640EU / ml; the hepatitis A inactivated vaccine to be tested Live vaccine sample T is also a product produced by the applicant in strict accordance with national standards, and its marked potency is A T It is 640EU / ml.

[0037] The solutions used are as follows:

[0038] 1. Phosphate buffer saline PBS: disodium hydrogen phosphate 58g, potassium dihydrogen phosphate 4g, sodium chloride 160g, add water for injection to 1000ml.

[0039] 2. PBS diluent: Dilute phosphate buffered saline PBS 20 times with water for injection.

[0040] 3. PBS washing solution: After diluting the phosphate buffer saline solution PBS 20 times with water for injection, add 0.05% Tween 20.

[0041] 4. Carbonate buffer solution: 1.6g o...

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Abstract

The invention provides a testing method of in vitro relative efficiency of inactivated hepatitis A vaccine. The traditional mouse in vivo relative efficiency testing method is thoroughly replaced, the negative factors of more influential factors, poor repeatability and 30 days of testing period which are caused by using animals are solved, the testing can be accomplished in only 3.5 hours, the vaccine storage is reduced, the effective period of the vaccine is indirectly prolonged, the labor intensity is reduced, 1,5 million to 2 million vaccines can be additionally produced when vaccine is insufficient particularly, and 45 million to 60 million production value can be output. In addition, the method adopts the double-parallel line biological assay principle, provides a testing method of in vitro relative efficiency of inactivated hepatitis A vaccine, and ensures that good linear regression is presented between HAV viral content and the logarithm corresponding to A value, and R is over 0.97; and the testing result demonstrates good stability and repeatability, therefore, the testing method is convenient, quick and reliable.

Description

technical field [0001] The invention relates to a method for testing the relative efficacy of an inactivated hepatitis A vaccine in vitro, belonging to the field of biotechnology. technical background [0002] At present, the effectiveness test of hepatitis A inactivated vaccine uses the mouse in vivo relative efficacy test method, and the basic process of the test is as follows: (1) After each batch of vaccines to be tested is mixed, it is serially diluted to 1:64 by 2 times, and the test is set up at the same time. The efficacy test reference product was used as a control; (2) 3 dilutions of 1:4, 1:16, and 1:64 were used to inoculate mice, and 10 mice were inoculated at each dilution, and each was injected intraperitoneally with 1.0ml for 4 weeks. After blood collection, separate the serum to be tested; (3) serum antibody determination: use the hepatitis A virus antibody detection kit to measure the anti-HAV antibody in the mouse serum; (4) result calculation: according to...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/576G01N33/543G01N33/531
Inventor 谢忠平龙润乡李华陈洪波宋霞黄铠洪超白惠珠杨蓉
Owner INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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