冻干甲型肝炎减毒活疫苗除菌过滤前后产品质量分析  

Quality of freeze-dried live attenuated hepatitis A vaccine before and after aseptic filtration

作　　者：周振歆 易力 常亚军 杨家方 汪启兵 马忠飞 董少忠 ZHOU Zhen-xin;YI Li;CHANG Ya-jun;YANG Jia-fang;WANG Qi-bing;MA Zhong-fei;DONG Shao-zhong(Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650031,Yunnan Province,China)

机构地区：[1]中国医学科学院医学生物学研究所,云南昆明650031

出　　处：《中国生物制品学杂志》2021年第12期1412-1417,共6页Chinese Journal of Biologicals

基　　金：国家科技攻关计划(2018ZX09737-011-002)。

摘　　要：目的研究冻干甲型肝炎减毒活疫苗增加除菌过滤工艺对疫苗产品质量的影响。方法选取2020年已完成生产的32批未经除菌过滤的冻干甲型肝炎减毒活疫苗和18批经除菌过滤的冻干甲型肝炎减毒活疫苗,按照企业注册标准的要求进行全项检测,并对除菌过滤前后冻干甲型肝炎减毒活疫苗的有效物质(病毒感染性滴度和热稳定性)及残留物质(牛血清白蛋白残留量、抗生素残留量和三氯甲烷残留量)进行独立样本t检验。结果增加除菌过滤工艺前后,所有批次的产品质量均符合企业注册标准的要求;经过独立样本t检验,冻干甲型肝炎减毒活疫苗的病毒感染性滴度、热稳定性、牛血清白蛋白残留量、抗生素残留量和三氯甲烷残留量在除菌过滤前后差异均无统计学意义(P均>0.05)。结论除菌过滤工艺对冻干甲型肝炎减毒活疫苗产品质量无影响。Objective To investigate the effect of aseptic filtration process on quality of freeze-dried live attenuated hepatitis A(HA)vaccine.Methods Thirty-two batches of freeze-dried live attenuated HA vaccine produced in 2020 without aseptic filtration and 18 batches with aseptic filtration were subjected to overall control tests according to the requirements of enterprise registration standards.The active substances(viral infectious titer and thermal stability)and residual substances(bovine serum albumin,antibiotics and chloroform)of freeze-dried live attenuated HA vaccine before and after aseptic filtration were determined and analyzed statistically by an independent sample t test.Results Before and after introduction of the aseptic filtration process,the quality of all batches of vaccines met the requirements of enterprise registration standards.Independent sample t test showed no significant differences in the viral infectious titer,thermal stability as well as residual bovine serum albumin,antibiotic and chloroform contents before and after aseptic filtration(each P>0.05).Conclusion Aseptic filtration process showed no effect on the quality of freeze-dried live attenuated HA vaccine.

关 键 词：冻干甲型肝炎减毒活疫苗 除菌过滤 产品质量 

分 类 号：R186[医药卫生—流行病学]