麻疹-流行性乙型脑炎联合减毒活疫苗的稳定性研究

目的考察麻疹-流行性乙型脑炎（乙脑）联合减毒活疫苗（Measles and Japanese Encephalitis Combined Attenuated Live Vaccine,M-JEV）的稳定性。方法将M-JEV,37℃放置7d,检测病毒滴度;2-8℃放置0-24个月,检测外观、水分、病毒滴度、安全试验、异常毒性,0月和18个月时进行全检;（-30±2）℃放置0-30个月,检测外观、水分、病毒滴度、安全试验、异常毒性,0月、18个月、30个月时进行全检。结果所有检测结果,均符合2010年版《中华人民共和国药典》三部麻疹减毒活疫苗和乙脑减毒活疫苗的质量标准。结论 M-JEV有较好的稳定性。

Stability of Measles and Japanese Encephalitis Combined,Attenuated,Live Vaccine

Objective To test stability of measles and Japanese encephalitis（ JE） combined,attenuated,live vaccine（ M-JEV） against the standards of the China Pharmacopeia.Methods M-JEV was stored in 3 conditions：（ 1） at 37℃ for 7 days to detect virus titer levels,（ 2） at 2 - 8℃ for 0 - 24 months,to assess appearance,detect water,determine virus titers,conduct a safety test,assess for abnormal toxicity,and conduct a comprehensive test at 0 and 18 months,and（ 3） at- 30 ± 2℃ for 0 - 30 months,to assess appearance,detect water,determine virus titers,conduct a safety test,assess for abnormal toxicity,and conduct a comprehensive test at 0,18 and 30 months.Results All test results met the quality standards of the Pharmacopeia of the People＇s Republic of China（ edition 2010,volume 3） for measles attenuated,live vaccine and Japanese encephalitis,attenuated live vaccine.Conclusion M-JEV stability was within the standards of the China Pharmacopeia.