生色底物法测定低分子肝素钠注射液效价  

Amidolitic Method with Chromogenic Substrate for Determining the Activity of Low Molecular Weight Heparin Sodium Injection

作　　者：谢继青[1] 梁爱君[2] 于燕莉 袁成 

机构地区：[1]中国人民解放军济南军区总医院药学部,山东济南250031 [2]中国人民解放军总后勤部卫生部药品仪器检验所,北京100071

出　　处：《解放军药学学报》2003年第3期221-223,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　测定低分子肝素钠注射液抗Ⅹa因子效价。方法　应用生色底物法。结果　测定 3批原料效价 ,结果与国家标准方法相比无显著性差异 ;测定 4批低分子肝素钠注射液抗Ⅹa因子效价分别为 4 4 75、4 933、4 84 1和 5 130IU ,分别占标示量的 89.5 %、98.6 %、96 .8%、10 2 .6 % ,符合国家标准规定。结论　本测定方法准确可行。Aim To determine the anti-FⅩa activity of low molecular weight heparin sodium injection.Methods Use the amidolitic method with chromogenic substrate.Results This method compared with the standard method had no evident difference.The activities of four group of low molecular weight heparin sodium injection determined by this method were 4 475,4 933,4 841 and 5 130 IU respectively,as 89.5%,98.6%,96.8% and 102.6% as the scalar quantity.Conclusion This measurement was exact and feasible.

关 键 词：生色底物法 低分子肝素钠注射液 测定 抗Xa因子活性 抗Ⅱα因子活性 

分 类 号：R973.2[医药卫生—药品]