目的 建立HPLC同時測定康復春口服液中毛蕊異黃酮葡萄糖苷、芒柄花苷、毛蕊異黃酮、芒柄花素、黃芪甲苷和人參皂苷Rb₁的方法。方法 采用Diamonsil C₁₈色譜柱（250 mm×4.6 mm，5 μm）；流動相：乙腈–0.2%甲酸溶液，梯度洗脫；檢測波長254 nm（0～30 min，檢測毛蕊異黃酮葡萄糖苷、芒柄花苷、毛蕊異黃酮和芒柄花素）、210 nm（30～36 min，檢測黃芪甲苷）和203 nm（36～50 min，檢測人參皂苷Rb₁）；體積流量：0.8 mL/min；柱溫：30℃；進樣量為20 μL。結(jié)果 毛蕊異黃酮葡萄糖苷、芒柄花苷、毛蕊異黃酮、芒柄花素、黃芪甲苷、人參皂苷Rb₁分別在3.29～82.25μg/mL（r＝0.999 1）、4.77～119.25μg/mL（r＝0.999 8）、4.16～104.00μg/mL（r＝0.999 2）、11.33～283.25μg/mL（r＝0.999 7）、7.39～184.75μg/mL（r＝0.999 9）、2.05～51.25μg/mL（r＝0.999 5）線性關(guān)系良好；平均加樣回收率分別為97.98%、98.45%、97.38%、99.72%、98.67%、96.99%，RSD值分別0.91%、1.41%、0.78%、1.09%、1.22%、0.85%。結(jié)論 方法專屬性強，結(jié)果準確，重復性好，為更好地評價康復春口服液的質(zhì)量提供參考。

Objective To develop an HPLC method for simultaneous determination of calycosin7-O-β-D-glucopyranoside, ononin, calycosin, formononetin, astragaloside IV, and ginsenoside Rb₁ in Kangfuchun Oral Liquid. Methods The determination was carried out on Diamonsil C₁₈ chromatographic column (250 mm×4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-0.2% formic acid solution with gradient elution. The detection wavelengths were set at 254 nm in 0-30 min to determine calycosin7-O-β-D-glucopyranoside, ononin, calycosin, and formononetin, 210 nm in 30-36 min to determine astragaloside IV, and 203 nm in 36-50 min to determine ginsenoside Rb₁. The flow rate was 0.8 mL/min, temperature of column was set at 30℃, and volume of injection was 20 μL. Results The linear range of calycosin7-O-β-D-glucopyranoside, ononin, calycosin, formononetin, astragaloside IV, and ginsenoside Rb₁ were 3.29-82.25 μg/mL(r=0.999 1), 4.77-119.25 μg/mL (r=0.999 8), 4.16-104.00 μg/mL(r=0.999 2), 11.33-283.25 μg/mL (r=0.999 7), 7.39 -184.75 μg/mL (r=0.999 9), 2.05 -51.25 μg/mL (r=0.999 5), respectively. The average recoveries were 97.98%), 98.45% 97.38%, 99.72%, 98.67%, and 96.99%, respectively. The corresponding RSD values were 0.91%, 1.41%, 0.78%, 1.09%, 1.22%, and 0.85%, respectively. Conclusion The method has strong specificity, accurate results, and good reproducibility which can provide a reference for quality of Kangfuchun Oral Liquid.

河南省醫(yī)學科技攻關(guān)計劃項目（201403190）