风疹减毒活疫苗病毒滴定国家参考品的制备及标定

Preparation and Calibration of National Reference for Titration of Live Attenuated Rubella Vaccine Virus

目的制备风疹减毒活疫苗病毒滴定国家参考品,并进行标定。方法选择国内风疹减毒活疫苗生产毒株BRDⅡ制备风疹减毒活疫苗参考品,并对其进行鉴别试验、水分含量、病毒滴度及无菌检查等检定;检定合格后,组织4个实验室对候选参考品和国际参考品的病毒滴度协作标定,计算实验室内和实验室间变异系数;对候选国家参考品进行稳定性分析。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1.7%,病毒滴度为4.6lgCCID50/ml。经协作标定,风疹减毒活疫苗病毒滴定候选国家参考品的病毒滴度为(4.56±0.52)lgCCID50/ml,实验室内变异系数在1.25%～2.94%之间,实验室间变异系数为5.72%;国际参考品的病毒滴度为(3.96±0.08)lgCCID50/ml,实验室内变异系数在1.19%～3.21%之间,实验室间变异系数为2.04%。经考察,该参考品具有较好的稳定性。结论制备的参考品符合作为风疹减毒活疫苗病毒滴定国家参考品的要求。

Objective To prepare and calibrate the national reference for titration of live attenuated rubella vaccine virus. Methods Live attenuated rubella vaccine reference was prepared with BRDⅡ 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 qualified in control tests as well as international reference 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. 7% and the virus titer was 4. 6 lgCCID50 / ml. The result of collaborative calibration showed that the virus titer of the prepared reference was （4. 56 ± 0. 52） lgCCID50 / ml, with intra-and inter-CVs of 1. 25% ～ 2. 94% and 5. 72% respectively; however, the virus titer of international refer-ence was （3. 96 ± 0. 08）lgCCID50 / ml, with intra-and inter-CVs of 1. 19% ～ 3. 21% and 2. 04% respectively. The prepared reference showed high stability. Conclusion The prepared reference met the requirements for national reference for titration of live atten-uated rubella vaccine.