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.
出处
《中国药事》
CAS
2012年第5期483-486,共4页
Chinese Pharmaceutical Affairs
关键词
胰激肽原酶
协作标定
标准品
pancreatic kininogenase
collaborative calibration
standard
