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血凝仪法测定注射用降纤酶效价方法研究 被引量:3

Pontency Determination of Defibrase by Blood Coagulation Analyzer
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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.
出处 《中国药师》 CAS 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)
关键词 降纤酶 血凝仪 凝血时间 Defibrase Blood coagulation analyzer Blood coagulation time
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