胰激肽原酶国家标准品的协作标定  

Collaborative Calibration of National Standard Pancreatic Kininogenase

作　　者：郝苏丽[1] 肖丽华[1] 刘建文[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：《中国药事》2012年第5期483-486,共4页Chinese Pharmaceutical Affairs

摘　　要：目的对第六批胰激肽原酶国家标准品的酶活力单位进行定值。方法以第五批胰激肽原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。结果本批胰激肽原酶国家标准品酶活性单位为46IU.支-1(加权均值标准差为0.0886,加权均值可信限范围为46.19～46.75)。结论第六批胰激肽原酶国家标准品通过了审核,可以取代第五批胰激肽原酶国家标准品。Objective To determine the enzyme activity unit of the sixth batch of national standard pancreatic kininogenase. Methods With the fifth batch of national standard pancreatic kininogenase for reference, multiple laboratories were organized for collaborative calibration using fibrin coagulation and standard curve and the data were statistically analyzed. Results The enzyme activity unit of this batch of national standard pancreatic kininogenase was 46 IU/bottle （weighted average standard deviation： 0. 0886; weighted average confidence interval range： 46.19-46.75）. Conclusion This batch of national standard pancreatic kininogenase has passed the audit and can replace the fifth batch of national standard pancreatic kininogenase.

关 键 词：胰激肽原酶 协作标定 标准品 

分 类 号：R927.1[医药卫生—药学]