麻疹减毒活疫苗国家参考品的制备及标定

为了制备麻疹减毒活疫苗国家参考品,选用国内麻疹疫苗生产株沪191制备麻疹疫苗参考品。生产过程中严格控制精密性、水分含量,对候选参考品进行鉴别试验、水分含量、病毒滴度及无菌检查等检验。检验合格后组织进行候选参考品病毒滴度协作标定,共有5个实验室参加了协作标定。协作标定完成后,对实验室内变异、实验室间变异及国际参考品在不同实验室间的变异进行了分析。此外还对疫苗进行了热稳定性和实时稳定性分析。结果显示经5个实验室协作标定后,麻疹减毒活疫苗国家参考品的滴度为4.96±0.26 lgCC ID50/m l,实验室内部变异在1.09%～4.64%之间,实验室间变异为2.62%。国际参考品在不同实验室间的变异为4.19%。稳定性考核数据表明制备的参考品具有较好的稳定性,符合作为麻疹减毒活疫苗国家参考品的要求,滴度为4.96±0.26 lgCC ID50/m l。

Establishment and collaborative study of national reference for measles vaccine(live)

To establish the national reference for measles live vaccine,Hu191 strain was selected to prepare the national reference for measles vaccine.The precision of technical process,residual moisture content and virus titer were determined.The potency of measles vaccine was assessed by collaborative study.Five participating laboratories carried out this study.The stablity of reference was also evaluated and the coefficients of variation（CV） was analized.The results showed that the titer of the national reference for measles vaccine is 4.96±0.26 lg CCID50/ml.The coefficients of variation are between 1.09%-4.64% within laboratory.The CV between laboratories is 2.62%.The CV of international reference for measles vaccine is 4.19%.The stability data indicated that the reference have good stability.The results of collaborative study and stability study demonstrated that the national reference for measles vaccine is suitable for its intend use.