目的 建立HPLC法測定乳疾靈顆粒中柴胡皂苷a、柴胡皂苷d、淫羊藿苷、淫羊藿次苷I、寶藿苷I、香附烯酮和α-香附酮，并采用化學計量學方法對測定結(jié)果進行綜合評價。方法 采用Agilent Zorbax SB-C₁₈色譜柱（250 mm×4.6 mm，5 μm），以乙腈-0.1%磷酸水溶液為流動相，梯度洗脫；檢測波長：210 nm（檢測柴胡皂苷a和柴胡皂苷d）、270 nm（檢測淫羊藿苷、淫羊藿次苷I和寶藿苷I）和242 nm（檢測香附烯酮和α-香附酮）；體積流量0.8 mL/min；柱溫25 ℃；進樣量10 μL。采用SPSS 26.0統(tǒng)計軟件對乳疾靈顆粒7種成分結(jié)果進行聚類分析和主成分分析。結(jié)果 柴胡皂苷a、柴胡皂苷d、淫羊藿苷、淫羊藿次苷I、寶藿苷I、香附烯酮和α-香附酮分別在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線性關系良好；平均回收率分別為98.42%、96.97%、99.97%、99.46%、97.87%、100.27%、98.43%；10批樣品聚類分析為2類，主成分1～3是影響乳疾靈顆粒質(zhì)量評價的主要因子。結(jié)論 該方法操作便捷、重復性好，為乳疾靈顆粒多指標質(zhì)量評價和臨床應用提供參考依據(jù)。

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

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