乙脑减毒活疫苗溶解稀释后稳定性观察

Stability of JEV SA_(14-14-2) (5 doses)After Dilution

目的观察乙脑减毒活疫苗（SA14-14-2）（5人份/瓶）溶解稀释后病毒的稳定性。方法将该乙脑减毒活疫苗加入稀释液PBS（2.5ml/瓶）,溶解稀释后分别置于2℃～8℃、20℃～25℃、37℃存放,在设置的不同时间点,分别测定病毒滴度,观察其病毒滴度变化趋势。结果该乙脑减毒活疫苗溶解稀释后在2℃～8℃、20℃～25℃存放至24h,在37℃存放至14h,病毒滴度下降,但符合《中国药典》2005年版的要求（≥5.7LgPFU/ml）;在37℃存放大于14h后,病毒滴度下降明显,不符合《中国药典》2005年版的要求（≥5.7LgPFU/ml）。结论乙脑减毒活疫苗溶解稀释后在2℃～8℃、20℃～25℃可存放24h,在37℃可存放14h,其病毒滴度符合《中国药典》2005年版的要求（≥5.7LgPFU/ml）。

Objective To observe the stability of the JEV SA14-14-2 （5 doses）after dilution. Method We dissolved and diluted the JEV SA14-14-2 （5 doses）with PBS, then separated the samples and stored them in 3 different temperatures which were 2 ℃-8 ℃,20 ℃-25 ℃,37 ℃. After that, measured the PFU at the end of every point-time, and researched the change tendency.Results After dilution, the PFU of the JEV SA14-14-2 （5 doses）decreased, but the PFU was still according with the pharmacopoeia of PRC（≥5.7 LgPFU/ml）, which was stored for 24 hours in 2 ℃-8 ℃,20 ℃-25 ℃,and stored for 14 hours in 37 ℃. After 14 hours, the PFU of sample which stored in 37 ℃decreased evidently, and it fell below the requirements of the pharmacopoeia of PRC（≥5.7 LgPFU/ml）. Conclusion After dissolving and diluting, the PFU of the JEV SA14-14-2 （5 doses）accord with the pharmacopoeia of PRC（≥5.7 LgPFU/ml）in 2 ℃-8 ℃,20 ℃-25 ℃ for 24 hours and 37 ℃ for 14 hours.