目的 建立HPLC法测定软脉灵口服液中毛蕊花糖苷、焦地黄苯乙醇苷B1、迷迭香酸、紫草酸、丹酚酸B、2，3，5，4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷和虎杖苷。方法 采用Venusil XBP C₁₈色谱柱（250 mm×4.6 mm，5μm）；以乙腈–0.1%甲酸水溶液为流动相，梯度洗脱；检测波长分别为330 nm（0～17 min检测毛蕊花糖苷和焦地黄苯乙醇苷B1）、280 nm（17～50 min检测迷迭香酸、紫草酸、丹酚酸B、2，3，5，4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷和虎杖苷）；体积流量1.0 mL/min；柱温30℃；进样量10μL。结果 毛蕊花糖苷、焦地黄苯乙醇苷B1、迷迭香酸、紫草酸、丹酚酸B、2，3，5，4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷和虎杖苷分别在1.23～30.75、0.59～14.75、0.71～17.75、1.47～36.75、9.78～244.50、6.57～164.25、1.19～29.75 μg/mL线性关系良好（r≥0.999 1）；平均回收率分别为99.14%、97.62%、96.84%、98.96%、100.11%、99.46%、98.92%，RSD值分别为1.15%、1.27%、1.02%、0.96%、0.65%、1.41%、0.87%。结论 该方法操作简便、重复性好，为软脉灵口服液中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 verbascoside, jionoside B1, rosmarinic acid, lithospermic acid, salvianolic acid B, 2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucoside, and polydatin in Ruanmailing Oral Liquid. Methods Venusil XBP C₁₈ column (250 mm×4.6 mm, 5 μm) was used with acetonitrile - 0.1% formic acid as mobile phase with gradient elution. The detection wavelength were set at 330 nm (for verbascoside and jionoside B1) and 280 nm (for rosmarinic acid, lithospermic acid, salvianolic acid B,2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucoside, and polydatin). The column temperature was 30 ℃, flow rate was set at 1.0 mL/min, and volume was 10 µL. Results Verbascoside, jionoside B1, rosmarinic acid, lithospermic acid, salvianolic acid B, 2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucoside, and polydatin showed good linear relationships within the ranges of 1.23 — 30.75, 0.59 — 14.75, 0.71 — 17.75, 1.47 — 36.75, 9.78 — 244.50, 6.57 — 164.25, and 1.19 — 29.75 μg/mL (r≥0.999 1). The average recoveries of those components were 99.14%, 97.62%, 96.84%, 98.96%, 100.11%, 99.46%, and 98.92% with the RSD values of 1.15%, 1.27%, 1.02%, 0.96%, 0.65%, 1.41%, and 0.87%, respectively. Conclusion The method is simple and repeatable, which provides reference for the quality evaluation and clinical application of Ruanmailing Oral Liquid.

R286.02

安徽省教育厅高校自然科学研究项目（KJ2017A770）