目的 建立乾坤丹（Ⅰ）中毛蕊异黄酮葡萄糖苷和芒果苷的HPLC测定方法。方法 采用HPLC法，Phenomenex C₁₈色谱柱（250 mm×4.6 mm，5 μm）；流动相为乙腈-0.5%甲酸，梯度洗脱；检测波长260 nm；体积流量1.0 mL/min；柱温30℃。结果 毛蕊异黄酮葡萄糖苷、芒果苷线性范围分别为0.374~5.984 μg、0.526~8.402 μg。毛蕊异黄酮葡萄糖苷、芒果苷的平均加样回收率分别为99.72%、100.15%，RSD值分别为1.37%、1.08%。结论 建立的方法简便、准确、灵敏度高、重复性好，为建立可靠的乾坤丹（Ⅰ）质量标准、更好地控制制剂质量提供有效借鉴。

Objective To develop an HPLC method for analysis of calycosin-7-O-β-D-glucoside and mangiferin in Qiankun Pills (Ⅰ). Methods The HPLC method was performed on Phenomenex C₁₈ column (250 mm×4.6 mm, 5 μm). The mobile phase was acetonitrile-0.5% phosphate solution with gradient elution. The detection wavelengths were set at 260 nm, the flow rate was 1.0 mL/min, and temperature of column was set at 30℃. Results The linear ranges of calycosin-7-O-β-D-glucoside and mangiferin were 0.374 -5.984 μg and 0.526 -8.402 μg, respectively. The average recoveries were 99.72% and 100.15% with RSD of 1.37% and 1.08%, respectively. Conclusion The method is simple, accurate, sensitive, and reproducible, which can provide effective reference for establishing reliable quality standard and better controlling the quality of Qiankun Pills (Ⅰ).

R286.02

天津市北辰区科技发展计划项目（2018-SHGY-28）