麻疹减毒活疫苗国家参考品长期稳定性评价

Long-term stability evaluation of national reference products for live attenuated measles vaccine

目的评价麻疹减毒活疫苗国家参考品的长期稳定性。方法对保存于-20℃的冻干麻疹减毒活疫苗国家参考品进行外观、水分含量、病毒滴度检测,并对2011—2021年的麻疹参考品滴度进行趋势分析。对2家企业的使用结果进行分析,与参考品的协作标定结果进行对比。结果经检测,参考品的外观检查符合规定,参考品中水分含量为1.48%;使用10余年的滴定结果显示,麻疹疫苗国家参考品的滴度在4.70~5.20 lgCCID_(50)/mL之间,均在质控范围内。年度均值在4.95~5.10 lgCCID_(50)/mL之间,年度检测的标准差在0.09~0.15 lgCCID_(50)/mL。趋势分析显示,参考品滴度稳定,以标示值为中心上、下波动,未出现明显下降趋势。2家疫苗企业的检测结果显示出相同趋势。结论麻疹减毒活疫苗国家参考品具有良好的长期稳定性,能够为国内相应疫苗的质控、签发提供保障。

Objective To evaluate the long-term stability of national reference product of live attenuated measles vaccine.Methods The appearance,moisture content,and virus titer of the lyophilized national reference products of live attenuated measles vaccine stored at-20℃were examined.The titers of the national reference products of live attenuated measles vaccine during 2011 to 2021 were analyzed for trends.The results of the 2 companies were analyzed and compared with the collaborative calibration results of the reference product.Results The appearance of the reference product was tested to be in compliance with the regulations,with a moisture content of 1.48%;the titration results for more than 10 years showed that the titers of the national reference product for measles vaccine ranged from 4.70 to 5.20 lgCCID_(50)/mL,all within the quality control range.The annual mean values ranged from 4.95 to 5.10 lgCCID_(50)/mL,and the standard deviations of the annual assays ranged from 0.09 to 0.15 lgCCID_(50)/mL.In the trend analysis,titers of the national reference for measles vaccine were stable and showed no sign of descending.Trend analysis showed that the titers of the reference product were stable,fluctuating up and down with the labeled values as the center,with no significant downward trend.The assay results of the two vaccine companies showed the same trend.Conclusion The national reference of live attenuated measles vaccine showed good long-term stability and can provide guarantee for the quality control and issuance of the corresponding vaccine in China.