矛头蝮蛇血凝酶工作标准品的协作标定  

Collaborative Calibration of Control Standards of Hemocoagulase Bothrops Atrox

作　　者：李秀琳 孙东 丁忠福 宁静 于翀 崔亮亮 薛雁 

机构地区：[1]辽宁远大诺康生物制药有限公司,沈阳110171

出　　处：《中国药品标准》2016年第2期123-127,共5页Drug Standards of China

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.

关 键 词：矛头蝮蛇血凝酶 工作标准品 协作标定 

分 类 号：R921.2[医药卫生—药学]