目的 建立HPLC法同時測定消風(fēng)止癢顆粒中毛蕊花糖苷、焦地黃苯乙醇苷B1、升麻素苷、升麻素、5-O-甲基維斯阿米醇苷、亥茅酚苷、蒼術(shù)素醇、白術(shù)內(nèi)酯Ⅱ和蒼術(shù)素，并采用化學(xué)計量學(xué)方法對檢測結(jié)果進(jìn)行綜合評價。方法 采用Agilent Zorbax SB-C₁₈色譜柱（250 mm×4.6 mm，5μm）；以乙腈-0.2%磷酸溶液為流動相，梯度洗脫；檢測波長：330 nm（0~14 min檢測毛蕊花糖苷和焦地黃苯乙醇苷B1）、254 nm（14~31 min檢測升麻素苷、升麻素、5-O-甲基維斯阿米醇苷和亥茅酚苷）、270 nm（31~55 min檢測蒼術(shù)素醇、白術(shù)內(nèi)酯Ⅱ和蒼術(shù)素）；體積流量0.9 mL/min；柱溫25℃；進(jìn)樣量10 μL。采用SPSS 26.0統(tǒng)計軟件對消風(fēng)止癢顆粒中9種成分進(jìn)行聚類分析和主成分分析。結(jié)果 毛蕊花糖苷、焦地黃苯乙醇苷B1、升麻素苷、升麻素、5-O-甲基維斯阿米醇苷、亥茅酚苷、蒼術(shù)素醇、白術(shù)內(nèi)酯Ⅱ和蒼術(shù)素分別在2.53~63.25、1.09~27.25、8.17~204.25、2.38~59.50、4.07~101.75、1.74~43.50、0.66~16.50、1.47~36.75、2.86~71.50μg/mL線性關(guān)系良好；平均回收率分別為99.01%、98.17%、100.13%、97.63%、98.72%、97.22%、96.93%、99.24%、100.01%，RSD值分別為1.42%、1.26%、0.72%、1.55%、0.84%、1.06%、1.18%、0.67%、0.95%；11批樣品聚類分析為3類，主成分1~3是影響消風(fēng)止癢顆粒質(zhì)量評價的主要因子。結(jié)論 該方法操作簡便、重復(fù)性好，可作為消風(fēng)止癢顆粒中多指標(biāo)成分質(zhì)量評價模式。

Objective To establish an HPLC method for determination of verbascoside, jionoside B1, prim-O-glucosylcimifugin, cimifugin, 5-O-methylvisammioside, sec-O-glucosylhamaudol, atractylodinol, atracylenolide II, and atractylodin in Xiaofeng Zhiyang Granules, and combine chemometrics analysis to comprehensive evaluation of Xiaofeng Zhiyang Granules. Methods The Agilent Zorbax SB-C₁₈ column (250 mm×4.6 mm, 5 μm) was used with acetonitrile-0.2% phosphoric acid solution as the mobile phase with gradient elution. The detection wavelength were set at 330 nm for verbascoside and jionoside B1, 254 nm for prim-O-glucosylcimifugin, cimifugin, 5-O-methylvisammioside, and sec-O-glucosylhamaudol, and 270 nm for atractylodinol, atracylenolide II, and atractylodin. The flow rate was set at 0.9 mL/min, column temperature was set at 25℃, and the injection volume was 10 μL. The cluster analysis and principal component analysis were conducted for the content results of nine constituents in Xiaofeng Zhiyang Granule by SPSS 26.0 statistical software. Results Verbascoside, jionoside B1, prim-O-glucosylcimifugin, cimifugin, 5-O-methylvisammioside, sec-O-glucosylhamaudol, atractylodinol, atracylenolide II, and atractylodin showed good linear relationships within the ranges of 2.53-63.25, 1.09-27.25, 8.17-204.25, 2.38-59.50, 4.07-101.75, 1.74-43.50, 0.66-16.50, 1.47-36.75, and 2.86-71.50 μg/mL, whose average recoveries were 99.01%, 98.17%, 100.13%, 97.63%, 98.72%, 97.22%, 96.93%, 99.24%, and 100.01% with the RSD values of 1.42%, 1.26%, 0.72%, 1.55%, 0.84%,1.06%, 1.18%, 0.67%, and 0.95%, respectively. The samples of 11 batches of Xiaofeng Zhiyang Granules were divided in to 3 categories. The principal component 1-3 was the main factor affecting the quality evaluation of Xiaofeng Zhiyang Granules. Conclusion The method is simple and repeatable, and can be used as an multi-index quality evaluation model for Xiaofeng Zhiyang Granules.

R286.02

河南省重大科技專項（創(chuàng)新示范專項）項目（191110311100）