摘要目的 对乙型脑炎减毒活疫苗(乙脑疫苗)的稳定性进行评价.方法 选取2种规格(1、5次人用剂量)的成品乙脑疫苗进行(25±2)、(37±2)℃条件下保存的加速稳定性试验,以及2～8℃条件下的长期稳定性考察,检定关键质量指标,并对长期稳定性数据进行回归分析.结果 4批1次人用剂量、2批5次人用剂量疫苗于(25±2)℃、相对湿度(60±5)％存放3个月,(37±2)℃、相对湿度(75±5)％存放14d,其外观、病毒滴度、水分、pH值均符合质量标准.9批1次人用剂量、7批5次人用剂量疫苗在2～8℃存放24个月的检定结果均符合质量标准.回归分析显示,在2～8℃存放时间每增加1个月,1、5次人用剂量疫苗的病毒滴度分别平均降低0.020和0.017 lg蚀斑形成单位/ml,水分分别平均增加0.055％和0.047％.根据回归方程因变量均值95％置信区间计算出的乙脑疫苗有效期远长于现行注册标准规定的18个月.结论 被检乙脑疫苗质量稳定性良好,产品安全可靠.

abstractsObjective To evaluate the stability of live attenuated Japanese encephalitis vaccine (JEV) product.Methods Two specifications (1-and 5-single human dose) of JEV were selected and stored at (25 ± 2) and (37 ± 2) ℃ in accelerated stability study,or at 2-8 ℃ in long-term stability study.Critical quality indicators were tested.Regression analysis was conducted using the long-term stability data.Results Four batches of 1-and 2 batches of 5-single human dose JEV were stored at (25 ± 2) ℃,relative humidity (RH) (60 ± 5) ％ for 3 months and (37 ± 2) ℃,RH (75 ± 5) ％ for 14 d,and their physical appearance,virus titer,moisture content and pH all met standards.All results from 9 batches of 1-and 7 batches of 5-single human dose vaccines stored at 2-8 ℃ for 24 months met standards.Regression analysis showed that,in average,for each prolonged storage month at 2-8 ℃,the virus titer of 1-and 5-single human dose vaccines decreased by 0.020 and 0.017 lg plaque-forming unit/ml,while the moisture content increased by 0.055％ and 0.047％,respectively.The validity period calculated by the 95 ％ confidence interval of dependent variable average in the regression equation was much longer than the validity period (18 months) specified in current registration standard.Conclusion The tested JEW product is stable,safe and reliable.