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
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[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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