第2代WHO百日咳毒素国际标准品的协作标定  

Collaborative calibration for the 2^(nd) generation WHO international reference standard of pertussis toxin

作　　者：卫辰[1] 晁哲[1] 吴燕[1] 王丽婵 骆鹏[1] 马霄[1] WEI Chen;CHAO Zhe;WU Yan;WANG Li-chan;LUO Peng;MA Xiao(National Institutes for Food and Drug Control,Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,Beijing 102629)

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定方法及其标准化重点实验室,北京102629

出　　处：《中国新药杂志》2018年第16期1855-1860,共6页Chinese Journal of New Drugs

摘　　要：目的:建立第2代WHO百日咳毒素国际标准品。方法:以第1代WHO百日咳毒素国际标准品为协作标定的标准品,对英国国家生物制品检定所提供的待标品和中国食品药品检定研究院内部参考品进行国际单位值测定和稳定性测定。测定方法为组胺致敏试验、CHO细胞簇集试验以及3项生化试验方法。结果:中国食品药品检定研究院完成了组胺致敏、CHO细胞簇集2项试验以及1项生化试验。结论:NIBSC经过对来自12个国家的14个实验室的结果进行统计学处理后,赋值第2代WHO百日咳毒素国际标准品组胺致敏活性为每支1 813 IU、CHO细胞簇集活性为每支680 IU,储存和运输稳定性符合要求。Objective： To establish the 2^ndgeneration WHO international reference standard of pertussis toxin. Methods： The candidate reagent provided by the NIBSC and NIFDC were assayed against the 1 stgeneration WHO pertussis toxin standard. The histamine sensitisation test,CHO cell clustering test and three biochemical test methods were used to calculate the IU and investigate the sability. Results： Two tests of histamine sensitization,CHO cell clustering test and a biochemical test were performed in NIFDC. Conclusion： After statistical analysis of the results from 14 laboratories in 12 countries,NIBSC assigned the histamine sensitization activity of the 2^nd generaion WHO pertussis toxin international reference standard to 1 813 IU·ampoule-1,CHO cell cluster activity to680 IU/ampoule. The storage and transport stabilities meet the requirements.

关 键 词：国际标准品 百日咳毒素 组胺致敏 CHO细胞簇集 

分 类 号：R927[医药卫生—药学] R392