乙型脑炎减毒活疫苗单一病毒收获液在2～8℃条件下储存的稳定性研究

摘要

目的 考察在现行工艺规定的2～8℃储存条件下,乙型脑炎减毒活疫苗(乙脑活疫苗)单一病毒收获液病毒滴度的稳定性.方法 取常规生产中收获的高、中、低滴度的单一病毒收获液各6批,按正常生产程序和工艺条件储存于2～8℃,自第5天起每隔1d无菌取样,进行病毒滴定,采用极差控制图、线性回归、单因素方差分析等方法对收获液的病毒滴度结果进行统计分析.结果 常规生产中高、中、低滴度段的单一病毒收获液在2～8℃储存21 d,各单一病毒收获液的病毒滴度均呈下降趋势,并且不同滴度段病毒收获液间的日均下降滴度差异无统计学意义(F=1.67,P=0.222),总体日均下降滴度为0.036 lg蚀斑形成单位/ml.结论 掌握了单一病毒收获液在工艺规定储存条件下的滴度下降趋势及日均下降水平,为乙脑活疫苗半成品的点配制及其病毒滴度的一致性控制提供了数据支持.%Objective To investigate the stability of live attenuated Japanese encephalitis vaccine (JEV) single harvests stored at 2-8 ℃ according to current production procedure.Methods Single harvests,6 lots each,of high,moderate,or low titer levels were stored at 2-8 ℃ for 21 d,and samples were taken every other day since day 5 for virus titration.Virus titers were analyzed by range control chart,linear regression,and one-way analysis of variance.Results After 21 d storage at 2-8 ℃,in single harvests at 3 different original viral levels from normal production,virus titers declined gradually.The average daily titer decline among them showed no statistically significant difference (F =1.67,P =0.222).Average daily titer decline was 0.036 lg plaque-forming unit/ml.Conclusion The titer decline trend and the average daily titer decline of JEV single harvests are found,which provides supporting data for better control of JEV final bulk formulation and titer consistency.