疫苗0~2℃储存挑战性实验  

Challenging experiment on vaccine storage environment at 0-2℃

作　　者：罗静[1] 南方[1] 赵田[2] 周扬[3] 彭维[4] 吕雪艳[4] Luo Jing;Nan Fang;Zhao Tian;Zhou Yang;Peng Wei;Lyu Xueyan(Quality Assurance Department,Chengdu Institute of Biological Products Co.,Ltd.,Sichuan Vaccine Engineering Technology Research Center,Chengdu 610023,China;Quality Compliance Management Department,Chengdu Institute of Biological Products Co.,Ltd.,Sichuan Vaccine Engineering Technology Research Center,Chengdu 610023,China;Chengdu Institute of Biological Products Co.,Ltd.,Sichuan Vaccine Engineering Technology Research Center,Chengdu 610023,China;Quality Control Department,Chengdu Institute of Biological Products Co.,Ltd.,Sichuan Vaccine Engineering Technology Research Center,Chengdu610023,China)

机构地区：[1]成都生物制品研究所有限责任公司质量保证部、四川省疫苗工程技术研究中心,成都610023 [2]成都生物制品研究所有限责任公司质量运营部、四川省疫苗工程技术研究中心,成都610023 [3]成都生物制品研究所有限责任公司、四川省疫苗工程技术研究中心,成都610023 [4]成都生物制品研究所有限责任公司质量检定室、四川省疫苗工程技术研究中心,成都610023

出　　处：《国际生物制品学杂志》2022年第5期247-250,共4页International Journal of Biologicals

基　　金：国家科技重大专项“重大新药创制”(2016ZX09101091)。

摘　　要：目的探讨冻干制剂乙型脑炎减毒活疫苗和液体制剂23价肺炎球菌多糖疫苗0~2℃条件下存放对其效价的影响。方法将冻干制剂乙型脑炎减毒活疫苗和液体制剂23价肺炎球菌多糖疫苗存放于0~2℃条件下一定时间后,与存放于2~8℃规定条件的制品进行疫苗效价的比较。结果1人份和5人份乙型脑炎减毒活疫苗在0~2℃条件下分别存放17 h 20 min和18 h 55 min,病毒滴度均符合5.7~7.1 lgPFU/ml的质量标准,且与存放于2~8℃规定条件的同批次疫苗比较,t值分别为0.26和0.28,P值均大于0.05,差异无统计学意义;23价肺炎球菌多糖疫苗在0~2℃条件下存放21 h 50 min,23个型别的多糖含量均符合35~65μg/ml的质量标准,且与存放于2~8℃规定条件的同批次疫苗比较,t值为0.01~2.25,P值均大于0.05,差异无统计学意义。结论冻干制剂乙型脑炎减毒活疫苗和液体制剂23价肺炎球菌多糖疫苗存放在0~2℃条件下的一定时间内,疫苗效价仍符合质量标准。Objective To investigate the effect on their potencies of lyophilized live attenuated Japanese encephalitis vaccine and liquid 23-valent pneumococcal polysaccharide vaccine when stored at 0-2℃.Methods The potencies of lyophilized live attenuated Japanese encephalitis vaccine and liquid 23-valent pneumococcal polysaccharide vaccine stored at 0-2℃after certain time were compared with same batch vaccines stored at 2-8℃.Results Lyophilized live attenuated Japanese encephalitis vaccines of 1-dose and 5-dose were stored at 0-2℃for 17 h 20 min and 18 h 55 min,respectively.The viral titers of 1-dose and 5-dose vaccines both met the quality standard of 5.7-7.1 lgPFU/ml,and the t values between titers of the same batch vaccines stored at 0-2℃and 2-8℃were 0.26 and 0.28,respectively,with P values>0.05,and there was no statistically significant difference.The 23-valent pneumococcal polysaccharide vaccine was stored at 0-2℃for 21 h 50 min.The polysaccharide contents of all 23 types met the quality standard of 35-65μg/ml,and the t values between polysaccharide contents of the same batch vaccines stored at 0-2℃and 2-8℃were 0.01-2.25 with P value>0.05,and there was no statistically significant difference.Conclusion The potencies of lyophilized live attenuated Japanese encephalitis vaccine and liquid 23-valent pneumococcal polysaccharide vaccine still meet the quality standard after store at 0-2℃for a certain time.

关 键 词：疫苗稳定性评价 日本脑炎疫苗 肺炎球菌多糖疫苗 挑战性实验 

分 类 号：R392-3[医药卫生—免疫学]