口服轮状病毒活疫苗稳定性评价  

Stability studies of oral rotavirus active vaccine

作　　者：石岩 张丽君 姜宝芹 刘晓凡 Shi Yan;Zhang Lijun;Jiang Baoqin;Liu Xiaofan(Quality Assurance Department,Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou 730046,China;Quality Control Department,Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou 730046,China)

机构地区：[1]兰州生物制品研究所有限责任公司质量保证部,730046 [2]兰州生物制品研究所有限责任公司质量检定室,730046

出　　处：《国际生物制品学杂志》2021年第4期198-201,共4页International Journal of Biologicals

摘　　要：目的评价兰州生物制品研究所有限责任公司(兰州公司)口服轮状病毒活疫苗的稳定性。方法选取兰州公司2014年生产的3批口服轮状病毒活疫苗,置于37℃条件下进行热稳定性试验,在0和7 d取样进行病毒滴度检查;置于25℃条件下进行加速稳定性试验,在0、1、2、3个月进行全部检定项目检查;置于2~8℃条件下进行长期稳定性试验,在0、3、6、9、12、15、18个月进行全部检定项目检查。结果口服轮状病毒活疫苗于37℃条件保存7 d,热稳定性试验符合质量标准(病毒滴度≥每毫升5.5 lg半数细胞培养物感染量,病毒滴度下降≤1.0 lg)。在25℃条件下保存3个月,全部检定项目均符合质量标准。在2~8℃条件下保存18个月,全部检定项目均符合质量标准。结论兰州公司生产的口服轮状病毒活疫苗质量稳定。Objective To evaluate the stability of oral rotavirus active vaccine.Methods Three consecutive batches of oral rotavirus vaccine produced by Lanzhou Institute of Biological Products Co.,Ltd.(Lanzhou Company)were selected.The virus titer was tested at 0 d and 7 d after stored in 37℃for thermal stability,all items were tested at 0,1,2,3 month after stored in 25℃for accelerated test,and all items were tested at 0,3,6,9,12,15,18 month after stored in 2-8℃for long-term stability test.Results Oral rotavirus vaccine was stored in 37℃for 7 d,and the thermal stability met the standard(virus titer≥5.5 lg 50%cell culture infectious dose per ml and decrease of virus titer≤1.0 lg).The samples were stored in 25℃for 3 months,and all test results met the standard.The samples were stored in 2-8℃for 18 months,and all test results met the standard.Conclusion The quality of oral rotavirus active vaccine produced by Lanzhou Company is stable.

关 键 词：轮状病毒疫苗 药物稳定性 质量控制 

分 类 号：R392-3[医药卫生—免疫学]