摘要
目的模拟重组乙型肝炎(简称乙肝)疫苗在冷藏存储过程中发生的异常低温情况,探讨短期异常低温储存对乙肝疫苗效力相关因素的影响。方法选取3个不同表达系统(酿酒酵母、汉逊酵母、CHO细胞)来源的乙肝疫苗,分别于0、-7、-20℃储存1或7 d,检测疫苗的吸附完全性、上清中铝离子含量、效价和体外相对效力,比较乙肝疫苗经短期异常低温储存后与2~8℃正常储存条件下的差异。结果经短期异常低温储存后,疫苗的吸附完全性、疫苗上清中铝离子含量未发生变化;3种乙肝疫苗的ED50在0.16~0.68μg之间波动;汉逊酵母乙肝疫苗体外相对效力的变化幅度不超过10%,酿酒酵母乙肝疫苗在-20℃冻存7 d后相对效力较2~8℃储存下降21.8%。结论短期异常低温储存后,乙肝疫苗仍能保持较好的吸附完全性,非胶体状态铝含量未发生变化,疫苗效价和体外相对效力在部分异常储存条件下出现下降,但仍符合质量标准要求。
Objective To investigate the effect of short-term abnormal low temperature storage on the potency-related factors of recombinant hepatitis B vaccine through simulating the abnormal temperature during storage and transportation.Methods A total of six batches of hepatitis B vaccine derived from three different expression systems(Saccharomyces cerevisiae,Hansenula polymorpha and CHO cells)were selected and stored at 0,-7 and-20 ℃ for 1 or 7 d separately.The difference in hepatitis B vaccines stored at low temperature and 2 ~ 8 ℃ were evaluated by determining the degree of adsorption,content of free aluminum in supernatant,in vivo potency and relative potency in vitro. Results After storage at low temperature for a short time,the degree of adsorption and content of free aluminum in supernatant of vaccine showed no significant change. The ED50 of vaccines derived from three expression systems were 0. 16 ~ 0. 68 μg. The change range of relative potency in vitro of vaccine derived from H. polymorpha was less than 10%,while that from S. cerevisiae decreased by 21. 8% after storage at-20 ℃ for 7 d as compared with that at 2 ~ 8 ℃. Conclusion Abnormal low temperature storage exerted less effect on the degree of adsorption and content of free aluminum of hepatitis B vaccines. Though declines of in vivo potency and relative potency in vitro were observed in certain abnormal conditions,the vaccines still met the standards for quality.
作者
方鑫
邱少辉
童海青
屈旭成
曹崴
饶洪冲
朱征宇
何鹏
胡忠玉
FANG Xin;QIU Shao-hui;TONG Hai-qing;QU Xu-cheng;CAO Wei;RAO Hong-chong;ZHU Zheng-yu;HE Peng;HU Zhong-yu(National Institutes for Food and Drug Control,Key Laborulory of the Ministry of Health for Research on Quality and Standardization of Biotech Producets,Beijing 102629,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2020年第4期361-365,共5页
Chinese Journal of Biologicals
基金
国家新药创制科技重大专项“创新生物技术药评价及标准化关键技术研究”(2018ZX09101001)。
关键词
乙型肝炎疫苗
低温
吸附完全性
效价
相对效力
Hepatitis B vaccine
Low temperature
Degree of adsorption
Potency
Relative potency
作者简介
通讯作者:胡忠玉.E-mail:huzy67@163.com;通讯作者:何鹏,E-mail:hepeng9553@163.com;方鑫,共享第一作者;邱少辉,共享第一作者。
