人甲型H7N9流感病毒全病毒灭活疫苗的稳定性  

Stability of inactivated whole virion H7N9 influenza A vaccine

作　　者：段鹏 石玮 周欣 许文婷 柳伟君 杨月莲 王石磊 DUAN Peng;SHI Wei;ZHOU Xin;XU Wen-ting;LIU Wei-jun;YANG Yue-lian;WANG Shi-lei(Shanghai Institute of Biological Products Co.,Ltd.,Shanghai 200051,China)

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》2021年第6期647-651,共5页Chinese Journal of Biologicals

基　　金：上海市科技型中小企业技术创新基金(1743901300)。

摘　　要：目的评价甲型H7N9流感病毒全病毒灭活疫苗的稳定性。方法将甲型H7N9流感病毒全病毒灭活疫苗分别置(37±2)℃保存0、7、14、21、28、35 d,(25±2)℃保存0、1、2、3、4个月,2~8℃保存0、3、6、9、12、15、18、21、24个月,于各时间点采用单向免疫扩散法检测样品的血凝素(hemagglutinin,HA)含量,并进行鉴别试验、外观、装量、pH、铝含量、无菌、异常毒性及细菌内毒素含量检测。结果甲型H7N9流感病毒全病毒灭活疫苗于(37±2)℃存放35 d后,HA含量下降幅度为10%~19%,(25±2)℃存放4个月后,HA含量下降幅度为2%~10%,2~8℃存放24个月后,HA含量下降幅度为5%~15%,其他各项指标均符合相关质量标准。结论甲型H7N9流感病毒全病毒灭活疫苗具有良好的稳定性。Objective To evaluate the stability of inactivated whole virion H7N9 influenza A vaccine.Methods The final product of inactivated whole virion H7N9 influenza vaccine were stored at(37±2)℃for 0,7,14,21,28 and 35 d,at(25±2)℃for 0,1,2,3 and 4 months,and at 2~8℃for 0,3,6,9,12,15,18,21 and 24 months,from which samples were taken at each time point and determined for hemagglutinin(HA)content,and subjected to identity test,inspection of containers,determination of filling quantity,pH value and aluminum content,as well as sterility test,abnormal toxicity test and determination of bacterial endotoxin content.Results The HA content in the vaccine decreased by 10%~19%after storage at(37±2)℃for 35 d,by 2%~10%at(25±2)℃for 4 months,and by 5%~15%at 2~8℃for 24 months,while the other indexes met the relevant quality standard.Conclusion Inactivated whole virion H7N9 influenza A vaccine showed good stability.

关 键 词：甲型H7N9流感病毒 灭活疫苗 稳定性 

分 类 号：R373.1[医药卫生—病原生物学] R392-33[医药卫生—基础医学]