血凝仪法测定注射用降纤酶效价方法研究  

Pontency Determination of Defibrase by Blood Coagulation Analyzer

作　　者：滕艳坤[1] 阚微娜[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药师》2012年第6期843-845,共3页China Pharmacist

基　　金：国家科技支撑计划课题(编号:2008BA2551304-3-2)

摘　　要：目的:建立血凝仪测定降纤酶效价的方法。方法:以纤维蛋白原为底物,采用血凝仪测定降纤酶对底物的凝固时间,根据对照品的凝固时间及效价,来计算降纤酶的效价。结果:降纤酶浓度在2.5～20 U.ml-1的范围内线性关系良好,回归方程:lgY=2.094 3lgX-0.785 0,r=-0.999 0。平均回收率为97.6%,RSD为1.16%(n=9)。结论:本方法简便、灵敏、准确。Objective： To establish the potency determination method of defibrase by blood coagulation analyzer. Method： The blood coagulation time was determined by blood coagulation analyzer, and the potency was calculated. Result： The calibration curve was linear within the range of 2.5-20 U ·ml-1. The average recovery was 97.6% with RSD of 1.16% （n = 9）, Conclusion： The method was simple, reliable and accurate, and can be applied in the quality control of the preparation.

关 键 词：降纤酶 血凝仪 凝血时间 

分 类 号：R917[医药卫生—药物分析学]