目的 采用高效液相色谱-蒸发光散射检测器法（HPLC-ELSD）建立复方石韦片中3种皂苷类成分黄芪皂苷I、Ⅱ和黄芪甲苷的含量测定方法，并考察这3种皂苷类成分在复方石韦片制剂工艺过程中的转移率，完善与提升复方石韦片的质量控制方法。方法 采用HPLC-ELSD法，使用Agilent 5-HC C₁₈（2）色谱柱（250 mm×4.6 mm，5μm），以乙腈-水为流动相进行梯度洗脱，体积流量1.0 mL/min，柱温30℃，进样量20 μL。ELSD参数：载气体积流量1.5 L/min，漂移管温度90℃，同时测定黄芪药材及复方石韦片成品、颗粒、浸膏样品中黄芪皂苷I、Ⅱ及黄芪甲苷的含量，并计算3种皂苷类成分在复方石韦片制剂过程中的转移率。结果 建立了复方石韦片及其制剂过程中黄芪皂苷I、Ⅱ和黄芪甲苷的含量测定方法，该条件下3个成分均达到基线分离，线性关系良好，平均加样回收率分别为99.58%、99.31%、99.51%，RSD值分别为3.0%、2.5%、2.5%。黄芪皂苷I在制剂过程中转移率较低，黄芪甲苷在制剂过程中转移率较高，且均大于100%。结论 本研究建立同时测定复方石韦片中黄芪皂苷I、Ⅱ和黄芪甲苷3种皂苷类成分的方法重现性好，专属性强，简便易行，同时可用于考察复方石韦片制剂工艺过程中3种皂苷类成分的转移率，完善了复方石韦片中皂苷类成分的质量控制标准，并为其他含黄芪中药制剂的质量控制提供参考。

Objective High performance liquid chromatography-evaporative light scattering detector (HPLC-ELSD) method was used to establish the determination method for the three kinds of saponins (astragaloside I, Ⅱ, and IV) in Compound Shiwei Tablets (CST), and investigate the three saponins components's transfer rate in the preparation process of CST in order to improve the quality control method of CST. Methods A HPLC-ELSD method was operated on the column of Agilent 5-HC C₁₈ (2) (250 mm×4.6 mm, 5 μm), with acetonitrile-water as the mobile phase for gradient elution, at a flow rate of 1.0 mL/min, with column temperature of 30℃ and injection volume of 20 μL. The ELSD parameters were as follow:the carrier gas flow rate was 1.5 L/min, the drift tube temperature was 90℃. Determinate the content of astragaloside I, Ⅱ, and IV in products, granules and extracts of CST, and calculate the transfer rate of three saponins in the preparation process of CST. Results A method for the determination of astragaloside I, Ⅱ, and IV in CST was established. Under this condition, all three components reached baseline separation with good linear relationship. The average recovery rates were 99.58%, 99.31% and 99.51%, and RSD values were 3.0%, 2.5% and 2.5%, respectively. Astragaloside I had lower transfer rate during the preparation process, and the transfer rate of astragaloside IV was the higher in the preparation process, both of which were greater than 100%. Conclusion This study established a method for simultaneous determination of three kinds of saponins of astragaloside I, Ⅱ, and IV in CST. The method has good reproducibility and strong specificity, which is simple and easy, and can be used to inspect the transfer rates of three kinds of saponins in the preparation process and improve the quality control standard of saponins in CST, and provide reference for the quality control of other traditional Chinese medicine preparations containing astragalus.