摘要
目的研制中量规模麻疹腮腺炎风疹(measles,mumps and rubella,MMR)联合减毒活疫苗。方法应用本所自主开发的麻疹病毒纯化沪-191株以及腮腺炎病毒 S_(79)株和风疹病毒 BRDⅡ株制备3种疫苗原液,检测3种疫苗原液按不同比例稀释后病毒的滴度变化和相互之间的干扰现象,确定MMR 疫苗中3种疫苗原液的配制比例和半成品配方。产品送国家检定部门进行全面质量检定。观察管制抗生素玻璃瓶包装疫苗的稳定性。结果 3种疫苗原液的病毒滴度在稀释体积增加1倍时下降幅度约为0.35～0.50 lg CCID_(50)/ml,3种病毒之间无明显干扰现象。麻疹、腮腺炎、风疹、稳定剂的配制比例为1:2:1:1。16批中试产品自检、7批产品经国家检定部门检定全部合格,保存21个月稳定性良好。结论产品全面达到临床前研究的标准。
Objective To prepare a live measles-mumps-rubella （MMR）combined vaccine on a semi-production scale. Methods Three monovalent virus pools were produced using the purified measles S191 strain developed by Shanghai Institute of Biological Products, mumps S79 strain and rubella BRD Ⅱ strain, respectively. Titer of each pool at different dilution and interference among the three viruses were evaluated. The proportion of each virus pool and the formulation of the final bulk were studied. The final products were sent to National Institute for the Control of Pharmaceutical and Biological Products （NICPBP）fot further determination,and the stability of the lyophilized combined vaccine in vial was ob- served. Results The virus titers of the three virus pools dropped 0.35-0. 50 lg CCIDs0/ml when the pools were diluted to double volume. No apparent interference was found among the three viruses. The formulation of the final bulk was established to be 1 ： 2 ： 1 ： 1（measles ： mumps ： rubella ： stabilizer）. All 16 batches of the products met the current quality requirements for the relevant monovalent vaccine and 7 batches of them were confirmed by NICPBP. The vaccine showed good stability after stored at 4- 8℃ for 21 months. Conclusion The combined vaccine meets requirements for preclinical research.
出处
《国际生物制品学杂志》
CAS
2007年第6期251-254,共4页
International Journal of Biologicals
作者简介
通讯作者：徐闻青，Email：xu-wq@sh163．net
