降纤酶国家标准品的协作标定  

Defibrase national standard for collaborative calibration

作　　者：郝苏丽[1] 杨化新[1] 范慧红[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2010年第6期1022-1025,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对第2批降纤酶国家标准品的酶活力单位定值。方法:以首批降纤酶国家标准品为基准,采用纤维蛋白凝结法,以标准曲线计算,组织多个实验室协作标定,并对数据进行统计处理。结果:本批降纤酶国家标准品酶活性单位为160U.支-1(加权均值标准差为1.29,加权均值可信限范围为156.8～164.0U.支-1)。结论:该批降纤酶国家标准品通过了审核,可以取代首批降纤酶国家标准品。Objective：To value activity units of the second batch of defibrase national standards.Methods：Using the first batch national standard defibrase as the standard,fibrin coagulation method,standard curve to calculate.Data processing several cooperative units results by statistics.Results：The approved national standard of defibrase units of activity of 160 units per bottle（the weighted average standard deviation of 1.29,Weighted mean confidence range of 156.8-164.0）.Conclusion：The defibrase countries standard adopted the audit,can be used as the second batch of defibrase national standards.

关 键 词：降纤酶 协作标定 标准品 

分 类 号：R917[医药卫生—药物分析学]