目的 建立高效液相色谱法同时测定山药丸中甘草苷、甘草酸铵、川续断皂苷Ⅵ、士的宁和马钱子碱。方法 使用Agilent Zorbax SB-C₁₈色谱柱（250 mm×4.6 mm，5 μm）；流动相：乙腈–0.1%磷酸水溶液，梯度洗脱；检测波长297 nm；体积流量1.0 mL/min；柱温25 ℃；进样量10 μL。结果 甘草苷、甘草酸铵、川续断皂苷Ⅵ、士的宁和马钱子碱分别在5.08～101.60、25.27～505.40、5.12～102.50、9.26～185.30、10.12～202.50 μg/mL线性关系良好，其平均回收率分别为98.21%、96.90%、96.32%、97.43%、97.29%，RSD值分别为0.44%、0.58%、1.64%、0.86%、0.64%。结论 该方法专属性好，操作简单，可为山药丸的质量标准提升提供依据。

Objective To establish an HPLC method for liquiritin, ammonium glycyrrhizinate, asperosaponin Ⅵ, strychnine, and brucine in Shanyao Pills. Methods The Agilent Zorbax SB-C₁₈ chromatographic column (250 mm × 4.6 mm，5 μm) was used, and the mobile phase was acetonitrile - 0.1% phosphoric acid solution with gradient elution. The detection wavelength was 297 nm, the flow rate was 1.0 μL/min, the injection volume was 10 μL, and the column temperature was 25 ℃. Results The linear ranges of liquiritin, ammonium glycyrrhizinate, asperosaponin Ⅵ, strychnine, and brucine were 5.08 — 101.60, 25.27 — 505.40, 5.12 — 102.50, 9.26 — 185.30, and 10.12 — 202.50 μg/mL, respectively. Their average recoveries were 98.21%, 96.90%, 96.32%, 97.43%, and 97.29%, with RSD values of 0.44%, 0.58%, 1.64%, 0.86%, and 0.64%, respectively. Conclusion This method has good specificity, simple operation, and can provide a basis for improving the quality standards of Shanyao Pills.

R284

河北省药品监督管理局科技计划项目（2022ZC1005）