腮腺炎减毒活疫苗国家参考品的制备及标定

Preparation and calibration of the national reference for titration of live attenuated mumps vaccine virus

目的：制备腮腺炎减毒活疫苗国家参考品,并进行标定。方法：选用国内腮腺炎疫苗生产毒株S79制备腮腺炎疫苗参考品。在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、病毒滴度、水分含量、牛血清蛋白残留量及无菌检查等试验。检验合格后组织4个实验室对候选参考品病毒滴度进行协作标定,计算实验室内变异及实验室间变异系数;对候选国家参考品进行稳定分析。结果：制备的候选参考品鉴别试验、无菌检查结果均符合规定,水分含量为1.6%。经协作标定,腮腺炎减毒活疫苗病毒滴定候选国家参考品的病毒滴度为（4.96±0.38）lgCCID50·mL^-1,实验室内变异系数在2.0%-4.1%之间;稳定性考核数据显示制备的参考品具有较好的稳定性。结论：制备的参考品符合作为腮腺炎减毒活疫苗国家参考品的要求。

Objective： To prepare and calibrate the national reference for titration of live attenuated mumps vaccine virus. Methods： Live attenuated mumps vaccine reference was prepared with S79 strain which was used for vaccine production in China,and subjected to control tests such as identity test,determination of moisture,virus titration and sterility test. The candidate references were calibrated in collaboration by four laboratories,based on which the intra-and inter-coefficients of variation（ CVs） were calculated,and the stability of candidate reference was analyzed. Results： The prepared candidate reference was qualified in identity and sterility tests,of which the moisture content was 1. 6%. The result of collaborative calibration showed that the virus titer of the prepared reference was（ 4. 96 ± 0. 38） lgCCID50·mL^- 1,with intra-and inter-CVs of 2. 0% -4. 1%. The prepared reference showed high stability. Conclusion： The prepared reference meets the requirements for the national reference for titration of live attenuated mumps vaccine.