目的 建立山菊降压胶囊中多指标成分高效液相色谱测定方法，并联合化学计量学方法对其进行综合质量评价。方法 以Eclipse Plus C₁₈柱（250 mm×4.6 mm，5 μm）为色谱柱，乙腈–0.1%磷酸为流动相进行梯度洗脱；检测波长分别为340 nm（0～22 min检测牡荆素葡萄糖苷、牡荆素鼠李糖苷和牡荆素）、284 nm（22～41 min检测橙黄决明素、黄决明素和美决明子素）和208 nm（41～75 min检测泽泻醇A、24-乙酰泽泻醇A和23-乙酰泽泻醇B）；柱温30℃；体积流量0.9 mL/min；进样量10 μL。采用SPSS 26.0统计软件对10批山菊降压胶囊含量测定结果进行主成分分析和聚类分析。结果 9种成分牡荆素葡萄糖苷、牡荆素鼠李糖苷、牡荆素、橙黄决明素、黄决明素、美决明子素、泽泻醇A、24-乙酰泽泻醇A和23-乙酰泽泻醇B线性范围良好，平均加样回收率96.90%～100.02%，RSD值均小于2.0%；聚类分析和主成分分析结果一致，10批山菊降压胶囊聚为2类，主成分1～3是影响山菊降压胶囊质量评价的主要因子。结论 所建立的HPLC法可用于山菊降压胶囊中9种指标成分牡荆素葡萄糖苷、牡荆素鼠李糖苷、牡荆素、橙黄决明素、黄决明素、美决明子素、泽泻醇A、24-乙酰泽泻醇A和23-乙酰泽泻醇B的定量控制和综合质量评价。

Objective To establish an HPLC method for determination of multi-index components in Shanju Jiangya Capsules, and the content determination results were comprehensive quality evaluated by chemometrics analysis. Methods The Eclipse Plus C₁₈ (250 mm×4.6 mm,5 μm) was used as the column with acetonitrile-0.1% phosphoric acid as the mobile phase. The detection wavelength were set at 340 nm for vitexin-4''-O-glucoside, rhamnosylvitexin, and vitexin, 284 nm for aurantio-obtusin, chrysoobtusin, and obtusifolin, and 208 nm for alisol A, alisol A, 24-acetate, and 23-acetate alisol B. The principal component analysis and cluster analysis of 10 batches of Shanju Jiangya Capsules by SPSS 26.0 statistical software. Results The nine components including vitexin-4''-O-glucoside, rhamnosylvitexin, vitexin, aurantio-obtusin, chryso-obtusin, obtusifolin, alisol A, alisol A 24- acetate, and alisol B 23-acetate had good linear relationships, whose average recoveries were 96.90%-100.02% (RSD < 2.0%). The results of principal component analysis and cluster analysis were consistent 10 batches of samples were clustered into 2 categories, and the principal component 1-3 was the main factor affecting the quality evaluation of Shanju Jiangya Capsules. Conclusion The established HPLC method can be used for the quantitative control and comprehensive quality evaluation of nine index components in Shanju Jiangya Capsules, including vitexin-4''-O-glucoside, rhamnosylvitexin, vitexin, aurantio-obtusin, chryso-obtusin, obtusifolin, alisol A, alisol A 24-acetate, and alisol B 23-acetate.

R286.02

河南省高等学校重点科研项目（20A360016）