李想　马宏达　吴琼

[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%， n=9）. The ratio of potency was during 0.9-1.1 for 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.

[Key words] Micro-chromogenic substrate method； Heparin sodium and inositol nicotinate cream； Anti-FXa； Potency

凍伤是指机体长时间暴露于寒冷环境，导致全身或局部体温下降而产生的损伤[1-2]。轻度冻伤，主要损伤皮肤、肌肉[3]，重度冻伤损伤肌肉和骨，甚至导致残废、危及生命[4-5]。沈阳军区总医院研制的肝素钠肌醇烟酸酯乳膏，防治冻伤效果显著。该制剂由肝素钠和肌醇烟酸酯组成[6]，通过扩张血管、改善微循环，使局部血流通畅，以消除冻伤部位红肿、疼痛等症状。肝素钠为硫酸氨基葡聚糖的钠盐，属于多糖类物质[7-8]，肝素钠与抗凝血酶Ⅲ结合，对凝血因子Ⅱa和Xa等具有抑制作用[9]，是临床应用最广泛的抗凝药物之一[10-11]。准确测定肝素钠抗Xa因子效价、测定抗Xa因子和抗Ⅱa因子的效价比，既保证了有效性，又提高了安全性。在此前的研究中，课题组建立了乳膏中抗Ⅱa因子的效价测定方法[12]。……