目的 建立乾坤丹（Ⅰ）中毛蕊異黃酮葡萄糖苷和芒果苷的HPLC測(cè)定方法。方法 采用HPLC法，Phenomenex C₁₈色譜柱（250 mm×4.6 mm，5 μm）；流動(dòng)相為乙腈-0.5%甲酸，梯度洗脫；檢測(cè)波長(zhǎng)260 nm；體積流量1.0 mL/min；柱溫30℃。結(jié)果 毛蕊異黃酮葡萄糖苷、芒果苷線性范圍分別為0.374~5.984 μg、0.526~8.402 μg。毛蕊異黃酮葡萄糖苷、芒果苷的平均加樣回收率分別為99.72%、100.15%，RSD值分別為1.37%、1.08%。結(jié)論 建立的方法簡(jiǎn)便、準(zhǔn)確、靈敏度高、重復(fù)性好，為建立可靠的乾坤丹（Ⅰ）質(zhì)量標(biāo)準(zhǔn)、更好地控制制劑質(zhì)量提供有效借鑒。

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

天津市北辰區(qū)科技發(fā)展計(jì)劃項(xiàng)目（2018-SHGY-28）