国产水痘减毒活疫苗的稳定性观察  

Stability of domestic live attenuated varicella vaccine

作　　者：马相虎[1] 沈坚[1] 陈哲文[1] 王亮[1] 沈谊清[1] 晏子厚[1] 

机构地区：[1]上海生物制品研究所有限责任公司,上海200051

出　　处：《中国生物制品学杂志》2014年第11期1375-1377,1383,共4页Chinese Journal of Biologicals

摘　　要：目的观察国产水痘减毒活疫苗的稳定性。方法取40批上海生物制品研究所有限责任公司（以下简称上海公司）2007~2013年生产的水痘减毒活疫苗,按照国家食品药品监督管理局批准的水痘减毒活疫苗注册标准和《中国药典》的要求进行各项检定：在0月进行热稳定性试验;在0和18月进行鉴别试验、物理检查、水分检测、无菌检查、异常毒性检查、牛血清白蛋白残留量检测、抗生素残留量检测（2010年10月以后生产的疫苗）;在0、6、12、18月进行病毒滴定。结果上海公司2007~2013年生产的水痘减毒活疫苗在有效期内各项指标检定结果均符合水痘减毒活疫苗注册标准和《中国药典》的相关要求。结论上海公司生产的水痘减毒活疫苗质量稳定,安全有效。Objective To evaluate the stability of domestic live attenuated varicella vaccine. Methods Forty batches of live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co.,Ltd.（SIBP） in 2007 ~2013 were subjected to overall control tests according to the standard for license of live attenuated varicella vaccine approved by the SFDA and the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition）. Heat stability test was performed at month 0,while identity test,physical examination,as well as tests for moisture,sterility,abnormal toxicity,residual bovine serum albumin and residual antibiotic（manufactured after October 2010） at months 0 and 18,and virus titration at months 0,6,12 and 18. Results All the quality indexes of live attenuated varicella vaccine manufactured by SIBP met the standard for license of live attenuated varicella vaccine and the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition）. Conclusion The live attenuated varicella vaccine manufactured by SIBP was stable,safe and effective.

关 键 词：水痘减毒活疫苗 稳定性 病毒滴定 

分 类 号：R373.12[医药卫生—病原生物学] R392-33[医药卫生—基础医学]