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目的建立骨痛宁胶囊的质量控制方法。方法用薄层色谱(TLC)法鉴别骨痛宁胶囊的主要成分当归、川芎和白芍,用高效液相色谱-蒸发光散射检测(HPLC-ELSD)法测定黄芪甲苷的量,以Diamonsil C18(250 mm×4.6 mm,5μm)柱为色谱柱,流动相为乙腈-水(34∶66),体积流量为1.0 mL/min,柱温30℃;ELSD条件:漂移管温度为105℃,高纯氮气体积流量为2.5 L/min。结果薄层色谱斑点清晰,分离度良好,阴性对照无干扰。黄芪甲苷在1.02~6.12μg线性关系良好(r=0.999 1),平均回收率为99.61%,RSD为2.80%。结论该方法操作简便,结果准确、可靠,重复性好、专属性强,可用于该制剂的质量控制。
Objective To establish the quality control method of Gutongning capsule. Methods TLC (TLC) was used to identify Angelica, Chuanxiong and Radix Paeoniae Alba, and the content of Astragaloside IV was determined by HPLC-ELSD with Diamonsil C18 (250 mm × 4.6 mm, 5 μm) column with acetonitrile-water (34:66) as the mobile phase at a volumetric flow rate of 1.0 mL / min and a column temperature of 30 ℃. ELSD conditions: drift tube temperature is 105 ℃, Pure nitrogen volume flow of 2.5 L / min. Results Thin layer chromatography spots clear, good resolution, negative control without interference. Astragaloside had a good linear relationship (r = 0.999 1) between 1.02 and 6.12 μg with an average recovery of 99.61% and a RSD of 2.80%. Conclusion The method is simple, accurate, reliable, reproducible and specific. It can be used for the quality control of the preparation.