第3次肝素国家标准品协作标定
Collaborative calibration to establish the 3rd National Standard for Un-fractionated Heparin
孟长虹 1宗卫峰 1陆益红1
作者信息
- 1. 江苏省食品药品监督检验研究院,南京 210008
- 折叠
摘要
目的 应中国食品药品检定研究院要求,协作标定第3次肝素国家标准品.方法 分别以第6次肝素国际标准品(07/328)、肝素国家标准品(150509-200912)为标准品,使用《中国药典》2015年版生色底物法测定4个待标品(编号为安瓿1、2、3、4)的抗FIIa效价和抗FXa效价;采用《中国药典》2010年版兔全血法测定抗凝效价.结果 江苏省食品药品监督检验研究院实验数据全部被采纳,用于第3次肝素国家标准品的效价计算.中国食品药品检定研究院对全国13个实验室提供的数据进行统计学分析,待标品(140817-201501)效价为2011 IU/安瓿.实验室内及实验室间的几何变异系数均小于10％.结论 经国家药品标准物质委员会审定后批准,待标品(140817-201501)用作肝素效价测定用国家标准品.
Abstract
Objective To establish the 3rd national standard for un-fractionated heparin for National Institutes for Food and Drug Control(NIFDC).MethodsFour candidate heparin samples(code ampoule 1,2,3,4)were assayed against the International Standard(07/328)and National Standard(150509-200912).Jiangsu Institute for Food and Drug Control(JSIFDC)determined the potency of anti-FXa and anti-FIIa by chromogenic substrate methods and the potency of anticoagulation by whole rabbit blood of Chinese Pharmacopoeia(2015).Results All of the data from our institute were adopted to calculate the 3rd national standard for un-fractionated Heparin.NIFDC analyzed the data from 13 laboratories.The geometric coefficient of variation of inter-laboratory and intra-laboratory were both below 10％.Conclusion Approved by the national drug standards material Committee,the candidate(140817-201501)was recommended to be the 3rd national standard for un-fractionated Heparin with an assigned value of 2011IU per ampoule.
关键词
肝素/国家标准品/协作标定/效价Key words
heparin/national standard/collaborative study/potency引用本文复制引用
出版年
2017
NETL
NSTL
维普
万方数据