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，5 μm）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1.02～6.12 μg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 standard for Gutongning Capsules. Methods Angelicae Sinensis Radix, Chuanxiong Rhizoma, and Paeoniae Alba Radix in Gutongning Capsules were identified by TLC. The content of astragaloside IV was determined by HPLC-ELSD. Using Diamonsil C₁₈ column (250 mm × 4.6 mm, 5 μm), the mobile phase was acetonitrile-water (34:66), The flow rate was 1.0 mL/min. Column temperature was 30℃; ELSD conditions: drift tube temperature of 105℃, high purity nitrogen flow rate of 2.5 L/min. Results The TLC spots were clear and well separated without negative interference. The measured value of astragaloside Ⅳ showed a good linear correlation between 1.02-6.12 μg (r=0.999 1). The average recovery was 99.61% and RSD was 2.80%. Conclusion The method is simple, accurate, reproductive, and highly specific. It can be used to control the quality of Gutongning Capsule.

中国中医科学院自主选题项目（No.2011xycz-11）