第3次低分子肝素国际标准品协作标定  

International collaborative calibration to establish the 3rd international standard for low molecular weight heparin

作　　者：李京[1] 王悦[1] 范慧红[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2014年第1期71-74,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立第3次低分子肝素国际标准品。方法:中国食品药品检定研究院以第2次低分子肝素国际标准品(01/608)为标准品,采用微量生色底物法测定待标品A(11/174)和待标品B(11/176)的抗FⅩa效价和抗FⅡa效价。结果:实验数据全部被采纳,用于第3次低分子肝素国际标准品的效价计算。结论:英国国家生物制品检定所对全球13个国家的22个实验室提交的数据进行统计分析,待标品B(11/176)的实验室间误差较小,各种方法的结果一致性较好,因此被推荐作为第3次低分子肝素国际标准品使用,抗FⅩa效价为1068 IU·安瓿-1,抗FⅡa效价为342 IU·安瓿-1。Objective： To establish the 3^rd international standard for low molecular weight heparin. Methods： Two candidate samples,coded A（11/174）and B（11/176）,were assayed against the 2^nd international standard（01/608）.The National Institutes for Food and Drug Control determined the potency of anti-FⅩa and anti-F Ⅱ a by micro-chromogenic substrate methods. Results： The whole data from our institute were adopted to calculate the potency of the 3rd international standard for low molecular weight heparin. Conclusion： British National Institute for Biological Standards and Control analyzed the data from 22 laboratories in 13 countries.Candidate B（11/176）had the lowest range of inter-laboratory variation,and overall,it had better inter-laboratory agreement for both anti-FⅩa and anti-F Ⅱ a activity and was in good agreement with the mean estimates by both the EP and USP monograph methods.It was therefore recommended to be the 3rd international standard for low molecular weight heparin with an assigned anti-FⅩa potency of 1068 IU per ampoule and anti-FⅡa potency of 342 IU per ampoule.

关 键 词：低分子肝素 国际标准品 协作标定 抗FⅩa效价 抗FⅡ a效价 微量生色底物法 

分 类 号：R917[医药卫生—药物分析学]