麻疹-流行性腮腺炎-流行性乙型脑炎联合减毒活疫苗的研究

Preparation and testing of a Measles,Mumps and Japanese Encephalitis Combined,Attenuated,Live Vaccine

目的研制麻疹-流行性腮腺炎(流腮)-流行性乙型脑炎(乙脑)联合减毒活疫苗(Measles,Mumps and Japanese Encephalitis Combined Attenuated Live Vaccine;M-M-JEV)。方法选用麻疹病毒沪191疫苗株、流腮病毒Wm84疫苗株和乙脑病毒SA14-14-2疫苗株,制备单价麻疹减毒活疫苗(Measles Attenuated Live Vaccine,MV)、流腮减毒活疫苗(Mumps Attenuated Live Vaccine,MuV)和乙脑减毒活疫苗(Japanese Encephalitis Attenuated Live Vaccine,JEV)原液,进行干扰试验、配比试验、保护剂筛选试验、冻干曲线的选择。结果确定了M-M-JEV的制备工艺,进行了M-MJEV的中试。中试的M-M-JEV经全面检定,各项指标均符合2010年版《中华人民共和国药典》(《中国药典》)三部单价MV、MuV和JEV的质量标准。动物试验未见病毒间交叉干扰,未见加重反应,未影响小鼠的免疫应答,表现出了良好的安全性和免疫原性。结论成功制备了M-M-JEV。

Objective To prepare and test a measles,mumps,and Japanese encephalitis（ JE） combined attenuated live vaccine（ M-M-JEV）.Methods The independently-developed,China ＇s Shanghai 191 measles vaccine strain,Wm 84 mumps vaccine strain,and Japanese encephalitis SA14-14-2 vaccine strain were selected to prepare three monovalent vaccines.With these,we conducted interference,ratio,and screening tests of the antigens,and selected freeze-dry curve test.Results The preparation processes for M-M-JEV were developed.Batches of the product met quality requirements for the three monovalent vaccines in accordance with the Pharmacopeia of the People＇s Republic of China（ edition 2010,volume 3）.Cross-interference and increased reactogenicity were not found in animal testing,and the immune response in mice was not affected,indicating that the combined vaccine had good safety and immunogenicity.Conclusion M-M-JEV was successfully prepared.