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目的观察乙型脑炎(乙脑)减毒活疫苗(SA14-14-2)病毒原液及成品疫苗的稳定性。方法取3批乙脑减毒活疫苗病毒原液,分别于20～25、2～8、-18～-22及-38～-42℃储存,间隔一定时间取样,检测病毒滴度;将2～8、-18～-22及-38～-42℃储存的在观察末期符合规定的病毒原液制备成品疫苗,观察其于2～8℃储存的稳定性。结果3批疫苗病毒原液在20～25℃储存16h、2～8℃储存12d、-18～22℃冻存3个月及-38～-42℃冻存6个月,病毒滴度均符合《中国药典》三部(2005版)的要求;由2～8℃储存12d、-18～-22℃冻存3个月、-38～-42℃冻存6个月的病毒原液所制备的成品疫苗2～8℃储存24个月,病毒滴度下降缓慢,且热稳定性良好,符合《中国药典》三部(2005版)的要求。结论乙脑减毒活疫苗病毒原液的稳定性随温度的变化而变化,温度越低,稳定性越好;所制备的相应成品疫苗,在观察期内稳定性良好。
Objective To observe the stability of the virus stock solution of the Japanese encephalitis (JE) live attenuated vaccine (SA14-14-2) and the finished vaccine. Methods Three batches of encephalitis attenuated live virus vaccine were collected and stored at intervals of 20-25, 2-8, -18-22 and -38- -42 ℃, respectively. The virus titer was measured at intervals of 2 ~ 8, -18 ~ -22 and -38 ~ -42 ℃ stored at the end of observation in line with the provisions of the virus stock solution prepared vaccine, observed at 2 ~ 8 ℃ storage stability. Results The three batches of vaccine virus stock solution were stored at 20-25 ° C for 16 h, stored at 2-8 ° C for 12 days, frozen at -18-22 ° C for 3 months and frozen at -38-42 ° C for 6 months, China Pharmacopoeia "(2005 Edition) requirements; from 2 ~ 8 ℃ stored 12d, -18 ~ -22 ℃ frozen for 3 months, -38 ~ -42 ℃ frozen for 6 months, the virus stock solution prepared by the finished product The vaccine was stored at 2-8 ℃ for 24 months. The virus titer decreased slowly and its thermal stability was good. It conformed to the requirement of the three parts of Chinese Pharmacopoeia (2005 edition). Conclusion The stability of the virus solution of live attenuated JE vaccine varies with temperature. The lower the temperature, the better the stability. The prepared vaccine has good stability during the observation period.