目的 建立复方地锦胶囊中槲皮素、山柰酚、木犀草素、芹菜素、大车前苷、毛蕊花糖苷、异毛蕊花糖苷和木通苯乙醇苷B的高效液相色谱测定方法，并结合化学计量学综合评价对其进行综合质量评价。方法 采用Acclaim 120 C₁₈色谱柱（250 mm×4.6 mm，5 μm）；乙腈–0.1%甲酸为流动相，梯度洗脱；体积流量1.0 mL/min；检测波长分别为360 nm（0~24 min检测槲皮素、山柰酚、木犀草素和芹菜素）、330 nm（24~60 min检测大车前苷、毛蕊花糖苷、异毛蕊花糖苷和木通苯乙醇苷B）；柱温30 ℃；进样量10 μL。采用SPSS 26.0统计软件对12批复方地锦胶囊中8种成分测定结果进行聚类分析和主成分分析。结果 8种成分线性范围良好（0.999 3≤r≤0.999 9）；平均加样回收率97.24%~100.08%；聚类分析和主成分分析结果一致，12批复方地锦胶囊聚为3类，主成分1~4是影响复方地锦胶囊质量评价的主要因子。结论 所建立的HPLC定量控制方法可用于复方地锦胶囊中多指标成分的综合质量评价。

Objective To establish an HPLC method for determination of quercetin, kaempferol, luteolin, apigenin, plantamajoside, verbascoside, isoacteoside, and calceolarioside B in Compound Dijin Capsules, and the content determination results were comprehensive quality evaluated by chemometrics analysis.Methods The separation was carried out on Acclaim 120 C₁₈ column (250 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile - 0.1% formic acid with gradient elution. The detection wavelength was set at 360 nm for quercetin, kaempferol, luteolin and apigenin, and 330 nm for plantamajoside, verbascoside, isoacteoside and calceolarioside B. The cluster analysis and principal component analysis were performed on the quantitative determination results of 8 components in 12 batches of Compound Dijin Capsules by SPSS 26.0 statistical software.Results The results showed that the eight components had good linear relationship (0.999 3≤ r ≤0.999 9), whose average recoveries were 97.24% — 100.08%. The results of cluster analysis and principal component analysis were consistent. 12 Batches of Compound Dijin Capsules samples were clustered into 3 categories, and the principal component 1 — 4 was the main factor affecting the quality evaluation of Compound Dijin Capsules.Conclusion The established HPLC method can be used for multi-index comprehensive quality evaluations of components in Compound Dijin Capsules.

R286.02

国家自然科学基金青年科学基金项目（81703357）