口服Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗的稳定性  

Stability of typesⅠand Ⅲ oral live attenuated poliomyelitis vaccine

作　　者：刘悦越[1] 赵岩[1] 杜加亮[1] 张韵祺 范行良[1] 刘艳[1] 于晴川[1] 高加梅 国泰[1] LIU Yue-yue;ZHAO Yan;DU Jia-liang;ZHANG Yun-qi;FAN Xing-liang;LIU Yan;YU Qing-chuan;GAO Jia-mei;GUO Tai(The Department of Enteric Virus Vaccine,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院肠道病毒疫苗室,北京102629 [2]云南大学数学与统计学院,云南昆明650091

出　　处：《中国生物制品学杂志》2019年第11期1195-1200,1205,共7页Chinese Journal of Biologicals

基　　金：《中国药典》药品标准提高课题（358）;国家科技重大专项“重大新药创制”(2018ZX09739002-002)

摘　　要：目的考察口服Ⅰ型Ⅲ型脊髓灰质炎减毒活疫苗在不同温度和pH环境下的稳定性。方法将6批疫苗分别于2~8℃放置6个月、22~25℃放置7 d、37℃放置7 d、-20℃放置27、30、33个月,或反复冻融5次;将疫苗pH调至3.0~10.0。采用细胞培养半数感染量(cell culture infective dose 50%,CCID50)法检测病毒总滴度及分型滴度。结果口服二价脊髓灰质炎减毒活疫苗在2~8℃保存6个月,22~25℃保存5 d,37℃保存2 d,反复冻融5次,-20℃保存27个月,pH 3.0~10.0环境下,疫苗效力均符合质量标准。结论疫苗的保存温度及时间对其稳定性均有影响。Objective To evaluate the stability of oral live attenuated poliomyelitis vaccine at various temperatures and pH values.Methods Six batches of vaccines were stored at 2~8℃ for 6 months,22~25℃ for 7 d,37℃ for 7 d,and at-20℃ for 27,30 and 33 months,respectively,or were repeatedly frozen and thawed for 5 times.The pH values of vaccines were adjusted to 3.0~10.0.The total virus titer and the virus titers of various types of the vaccines were determined by median cell culture infective dose(CCID50)methods.Results The potency of the vaccine met the quality standard after storage at 2~8℃ for 6 months,at 22~25℃ for 5 d,at 37℃ for 2 d,after repeat freezing and thawing for 5 times,after storage at-20℃ for 27 months,or after adjustment of pH value to 3.0~10.0.Conclusion Both the temperature and time for storage showed influence on the stability of vaccine.

关 键 词：脊髓灰质炎 二价疫苗 稳定性 

分 类 号：R373.22[医药卫生—病原生物学] R392-33[医药卫生—基础医学]