目的 建立HPLC法测定乳疾灵颗粒中柴胡皂苷a、柴胡皂苷d、淫羊藿苷、淫羊藿次苷I、宝藿苷I、香附烯酮和α-香附酮，并采用化学计量学方法对测定结果进行综合评价。方法 采用Agilent Zorbax SB-C₁₈色谱柱（250 mm×4.6 mm，5 μm），以乙腈-0.1%磷酸水溶液为流动相，梯度洗脱；检测波长：210 nm（检测柴胡皂苷a和柴胡皂苷d）、270 nm（检测淫羊藿苷、淫羊藿次苷I和宝藿苷I）和242 nm（检测香附烯酮和α-香附酮）；体积流量0.8 mL/min；柱温25 ℃；进样量10 μL。采用SPSS 26.0统计软件对乳疾灵颗粒7种成分结果进行聚类分析和主成分分析。结果 柴胡皂苷a、柴胡皂苷d、淫羊藿苷、淫羊藿次苷I、宝藿苷I、香附烯酮和α-香附酮分别在0.86～21.50、0.68～17.00、2.57～64.25、1.19～29.75、1.48～37.00、1.71～42.75、0.59～14.75 μg/mL线性关系良好；平均回收率分别为98.42%、96.97%、99.97%、99.46%、97.87%、100.27%、98.43%；10批样品聚类分析为2类，主成分1～3是影响乳疾灵颗粒质量评价的主要因子。结论 该方法操作便捷、重复性好，为乳疾灵颗粒多指标质量评价和临床应用提供参考依据。

Objective To establish an HPLC method for determination of saikosaponin a, saikosaponin d, icariin, icarisid I, baohuoside Ⅰ, cyperotundone, and α-cyperone in Rujiling Granules, and combine chemometrics to comprehensively evaluate the quality of Rujiling Granules. Methods The chromatographic column was Agilent Zorbax SB-C₁₈ column (250 mm×4.6 mm,5 μm). The mobile phase was composed of acetonitrile-0.1% phosphoric acid aqueous solution with gradient elution at a flow rate of 0.8 mL/min. The column temperature was 25℃. The detection wavelength were set at 210 nm for saikosaponin a and saikosaponin d, 270 nm for icariin, icarisid I, baohuoside Ⅰ, and 242 nm for cyperotundone and α-cyperone. The cluster analysis and principal component analysis were conducted for the content results of seven constituents in Rujiling Granules by SPSS 26.0 Statistical Software. Results Saikosaponin a, saikosaponin d, icariin, icarisid I, baohuoside Ⅰ, cyperotundone, and α-cyperone showed good linear relationships within the ranges of 0.86-21.50, 0.68-17.00, 2.57-64.25, 1.19-29.75, 1.48-37.00, 1.71-42.75, and 0.59-14.75 μg/mL, whose average recoveries were 98.42%, 96.97%, 99.97%, 99.46%, 97.87%, 100.27%, and 98.43%, respectively. The samples of 10 batches of Rujiling granules could be divided in to 2 categories. The principal component 1-3 were the main factor affecting the quality evaluation of Rujiling Granules. Conclusion The method is easy to operate and repeatable, which can provide reference for the quality evaluation and clinical application of Rujiling Granules.

R284.1

广西重点实验室建设项目（17-259-34）