第六次肝素国际标准品协作标定

International Collaborative Study on Developing the 6th International Standard for Unfractionated Heparin

目的建立第六次肝素国际标准品。方法中国药品生物制品检定所以第五次肝素国际标准品(97/578)为标准品,对6个待标品(编号为:T、W、V、X、Y、Z)进行测定,共使用了5种实验方法估计待标品的效价,它们分别是:生色底物法测定抗FXa效价、生色底物法测定抗FIIa效价、《中国药典》2010年版兔全血法测定抗凝效价、《欧洲药典》6.0版羊血浆活化部分凝血酶时间法(activated partial thromboplastin time,APTT)测定抗凝效价、《美国药典》XXX II版羊血浆法测定抗凝效价。结果我所的实验数据全部被采纳,用于第六次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36个实验室提交的数据进行综合分析,待标品W(07/328)的实验室内及实验室间的误差都是最小的,因此被推荐作为第六次肝素国际标准品使用,效价为2145 IU.安瓿-1。

OBJECTIVE To establish the 6th international standard for unfractionated heparin and to develop an international col- laborative study. METHODS Six candidate unfractionated heparin samples（ code： T, W, V, X, Y, Z ） were assayed against the 5th International Standard （97/578）. National institute for the control of pharmaceutical ＆ biological products used five different methods in this study： anti-Xa chromogenic assay, anti-Ila chromogenic assay, whole rabbit blood of Chinese Pharmacopoeia（ CHP）, clot-based sheep plasma assay of European Pharmacopoeia （EP） and clot-based sheep plasma of US Pharmacopoeia（USP）. RESULTS The data from our lab were adopted all to calculate the potency of the 6th international standard for unfraetionatcd heparin. CONCLUSION National institute for biological standards and control analyzed the date fi＇om 36 laboratories. Candidate W （07/328） gave the lowest range of intra- and inter-laboratory variation. It is therefore recommended to be the 6th international standard for unfractionated heparin with an assigned value of 2 145 IU · ampoule ^-1 obtained from all assay methods.