目的 建立山菊降壓膠囊中多指標(biāo)成分高效液相色譜測(cè)定方法，并聯(lián)合化學(xué)計(jì)量學(xué)方法對(duì)其進(jìn)行綜合質(zhì)量評(píng)價(jià)。方法 以Eclipse Plus C₁₈柱（250 mm×4.6 mm，5 μm）為色譜柱，乙腈–0.1%磷酸為流動(dòng)相進(jìn)行梯度洗脫；檢測(cè)波長(zhǎng)分別為340 nm（0～22 min檢測(cè)牡荊素葡萄糖苷、牡荊素鼠李糖苷和牡荊素）、284 nm（22～41 min檢測(cè)橙黃決明素、黃決明素和美決明子素）和208 nm（41～75 min檢測(cè)澤瀉醇A、24-乙酰澤瀉醇A和23-乙酰澤瀉醇B）；柱溫30℃；體積流量0.9 mL/min；進(jìn)樣量10 μL。采用SPSS 26.0統(tǒng)計(jì)軟件對(duì)10批山菊降壓膠囊含量測(cè)定結(jié)果進(jìn)行主成分分析和聚類分析。結(jié)果 9種成分牡荊素葡萄糖苷、牡荊素鼠李糖苷、牡荊素、橙黃決明素、黃決明素、美決明子素、澤瀉醇A、24-乙酰澤瀉醇A和23-乙酰澤瀉醇B線性范圍良好，平均加樣回收率96.90%～100.02%，RSD值均小于2.0%；聚類分析和主成分分析結(jié)果一致，10批山菊降壓膠囊聚為2類，主成分1～3是影響山菊降壓膠囊質(zhì)量評(píng)價(jià)的主要因子。結(jié)論 所建立的HPLC法可用于山菊降壓膠囊中9種指標(biāo)成分牡荊素葡萄糖苷、牡荊素鼠李糖苷、牡荊素、橙黃決明素、黃決明素、美決明子素、澤瀉醇A、24-乙酰澤瀉醇A和23-乙酰澤瀉醇B的定量控制和綜合質(zhì)量評(píng)價(jià)。

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

河南省高等學(xué)校重點(diǎn)科研項(xiàng)目（20A360016）