[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/mL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。

    [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

    [中图分类号] R961 [文献标识码] A [文章编号] 1673-7210(2017)08(a)-0030-03

    [Abstract] 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/mL (r=0.996). The average recovery in three levels was 99.5% (RSD=1.92% ......