目的 建立昆仙胶囊HPLC特征指纹图谱结合多成分含量测定的方法，为其质量控制提供参考。方法 采用Agilent Zorbax SB-C₁₈（250 mm×4.6 mm，5 μm）色谱柱，以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱，体积流量为0.8 mL/min，柱温33℃，检测波长270 nm。以朝藿定A为参照峰，建立15批昆仙胶囊特征指纹图谱，采用中药色谱指纹图谱相似度评价系统软件（2012A版）、聚类分析及偏最小二乘法-判别分析方法进行评价，同时测定金丝桃苷、朝藿定A、朝藿定B、朝藿定C、淫羊藿苷以及宝藿苷I的含量。结果 建立了昆仙胶囊特征指纹图谱，共标定了21个共有峰，并通过对照品指认了其中的15个成分，各批次样品的相似度均大于0.9。金丝桃苷、朝藿定A、朝藿定B、朝藿定C、淫羊藿苷及宝藿苷I在各自范围内线性关系良好（r>0.999），15批昆仙胶囊样品中上述6个成分的质量分数分别为2.817～7.527、7.287～9.103、8.730～18.675、33.377～70.371、35.297～50.291、4.059～9.079 mg/g。结论 建立了昆仙胶囊特征指纹图谱结合多成分同时测定的方法，简便、准确、重现性好，可用于昆仙胶囊的质量控制。

Objective In order to provide a scientific basis for the quality control of Kunxian Capsules (KC), HPLC characteristics chromatogram combined with multi-components determination was established. Methods The analysis was performed on Agilent Zorbax SB-C₁₈ column (250 mm×4.6 mm, 5 μm), using acetonitrile and 0.1% phosphoric acid solution as the mobile phase at a flow rate of 0.8 mL/min for gradient elution, the column temperature was 33℃, and the detection wavelength was 270 nm. The fingerprints of 15 batches of KC were established and evaluated by the similarity evaluation system of TCM (2012A version), hierarchical cluster analysis and discriminant analysis of partial least squares. Furthermore, the content of hyperoside, epimedin A, epimedin B, epimedin C, icariin and baohuoside Ⅰ were determined. Results The HPLC fingerprint with 21 common peaks of KC was established, and the similarities of samples were over 0.9. The linearity relationships separated with hyperoside, epimedin A, epimedin B, epimedin C, icariin and baohuoside Ⅰ were good, and the contents of the above-mentioned components in 15 batches of preparations were 2.817-7.527, 7.287-9.103, 8.730-18.675, 33.377-70.371, 35.297-50.291 and 4.059-9.079 mg/g, respectively. Conclusion The combination methods of HPLC characteristic chromatograms and simultaneous determinations of multiple components are rapid, simple and reproducible, which can provide methodological reference for the quality control of KC.

R286.02

国家重点研发项目（2018YFC1707300）