乙型脑炎减毒活疫苗(SA_(14-14-2))病毒原液及成品疫苗的稳定性观察

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。

Stabilities of Bulk and Final Product of Live Attenuated Japanese Encephalitis Vaccine(SA_(14-14-2))

Objective To observe the stabilities of bulk and final product of live attenuated Japanese encephalitis(JE)vaccine (SA14-14-2). Methods Three batches of bulk of live attenuated JE vaccine (SA14-14-2)were stored at 20 ～ 25, 2 ～ 8, -18 ～ -22 and -38 ～ -42℃ separately and determined for virus titers periodically. The bulks stored at 2 ～ 8, -18 ～ -22 and -38 ～ -42℃, which met the relevant requirements at the end of observation periods, were prepared into final products and observed for stabilities at 2 ～ 8℃. Results The titers of 3 batches of bulks after storage at 20 ～ 25℃ for 16 h, 2 ～ 8℃ for 12 d, -18 ～ -22℃ in frozen for 3 months and -38 ～ -42℃ in frozen for 6 months met the requirements in Chinese Pharmacopoeia (2005 edition). The titers of final products prepared with bulks stored at 2 ～ 8℃ for 12 d, -18 ～ -22℃ in frozen for 3 months and -38 ～ -42℃ in frozen for 6 months decreased gradually after storage at 2 ～ 8℃ for 24 months, and the vaccine showed good thermal stability, which met the requirements in Chinese Pharmacopoeia(2005 edition). Conclusion The stability of bulk of live attenuated JE vaccine increased with the decreasing temperature, and the prepared vaccine showed good stability in observation period.