乙型脑炎减毒活疫苗病毒滴度参考品(200010)的建立和标定

Establishment and Standardization of Japanese Encephalitis (JE) Attenuated Live Reference Vaccine for Virus Titration

乙型脑炎减毒活疫苗病毒滴度的检测是疫苗活性和效力的直接数据佐证 ,是一项关键的指标。为了控制病毒检测系统的误差 ,建立了乙型脑炎病毒滴度参考品 (批号 2 0 0 0 10 )。该批参考品的制备工艺同乙脑活疫苗的生产工艺。参考品病毒滴定采用金黄色地鼠传代细胞 (BHK— 2 1)蚀斑滴定法。该批乙脑减毒活疫苗病毒滴度参考品病毒滴度平均值 7 0lgPFU·ml-1,试验检测范围 (± 2S) :6 7～ 7 3lgPFU·ml-1。

In general the potency of a live vaccine depends on the virus content of the vaccine. Therefore titration of virus titer is an important item for the vaccine quality control. For the control of titration system error, reference vaccine was established. The vaccine was made from Chengdu Institute and made standardization by a collaborative assay including four institutes. The method of titration was plaque assay in BHK-21 cells. The average titer of JE reference vaccine was 7 0 LgPFU/ml. Testing limit was 6 7～7 3LgPFU/ml.