微量生色底物法测定肝素钠肌醇烟酸酯乳膏中抗Xa因子效价  

Determination of anti-FXa potency in heparin sodium and inositol nicoti-nate cream by micro-chromogenic substrate method

作　　者：李想[1] 马宏达[1] 吴琼[1] 侯明晓[1] LI Xiang MA Hongda WU Qiong HOU Mingxiao(Department of Pharmacy, General Hospital of Shenyang Military Command, Liaoning Province, Shenyang 110016, China)

机构地区：[1]沈阳军区总医院药学部,辽宁沈阳110016

出　　处：《中国医药导报》2017年第22期30-32,共3页China Medical Herald

基　　金：国家十二五重大新药创制项目(2013ZX09J13109-03B)

摘　　要：目的建立肝素钠肌醇烟酸酯乳膏中抗Xa因子效价的测定方法。方法对肝素钠肌醇烟酸酯乳膏进行破乳处理后,采用微量生色底物法、生物检定统计法,测定乳膏中抗Xa因子的效价。结果建立了肝素钠肌醇烟酸酯乳膏中肝素钠抗Xa因子的测定方法,抗Xa因子在0.0250~0.1020 IU/m L范围内与吸光度(A)值线性关系良好(r=0.996);低、中、高浓度的平均回收率为99.5%,RSD为1.92%(n=9)。抗Xa因子和抗Ⅱa因子的效价比值在0.9~1.1范围内。结论该方法结果准确,重复性好,可用于肝素钠肌醇烟酸酯乳膏中抗Xa因子效价的测定,有效控制该制剂的质量。Objective To establish a method for determination of anti-FXa potency in heparin sodium and inositol nicotinate cream. Methods The emulsion was broken. The anti-FXa potency was determined by micro-chromogenic substrate method and biological test statistics method. Results The determination method was established for anti-FXa potency in heparin sodium and inositol nicotinate cream. The linear range of anti-FXa was during 0.0250-0.1020 IU/m L（r=0.996）. The average recovery in three levels was 99.5%（RSD=1.92%, n=9）. The ratio of potency was during 0.9-1.1for anti-FXa and anti-FⅡa. Conclusion The method is accurate and reproduceable. It can be used for the determination of anti-FXa potency in order to control the quality of heparin sodium and inositol nicotinate cream.

关 键 词：微量生色底物法 肝素钠肌醇烟酸酯乳膏 抗XA因子 效价 

分 类 号：R961[医药卫生—药理学]