摘要
目的:标定我公司生产矛头蝮蛇血凝酶工作标准品。方法:以蛇毒血凝酶质量标准WS-349( X-317)-2001中效价测定为基础,改进测定方法,组织多名实验人员协作标定,并对数据进行统计分析。结果:本批矛头蝮蛇血凝酶工作标准品酶活性单位为103 U/支,加权均值标准差为0.8068,95%加权均值可信限的范围为101.0-105.1 U/支。结论:我公司生产的矛头蝮蛇血凝酶工作标准品标化科学、赋值准确,可以用于本公司产品的效价检测。
Objective:To calibrate the control standards of Hemocoagulase Bothrops atrox of our company.Methods:The enzyme ac-tivity was assayed based on the titration of Hemocoagulase Atrox Quality Standard WS-349(X-317)-2001, the method was modified, more than a number of experimenters were organized to collaboratively calibrate and the data was statistically analyzed.Results: The activity of the control standards of Hemocoagulase Bothrops atrox was 103 units per bottle, the weighted average standard deviation was 0.806 8, and the 95%weighted mean confidence range was 101.0-105.1 units per bottle.Conclusion:The calibration of the control standards of Hemocoagulase Bothrops atrox is scientific and accurate, and can be used to detect the titers of our company′s products.
出处
《中国药品标准》
CAS
2016年第2期123-127,共5页
Drug Standards of China
关键词
矛头蝮蛇血凝酶
工作标准品
协作标定
Hemocoagulase Bothrops atrox
standard substance
collaborative calibration