目的 建立RP-HPLC 法测定保肝丸中五味子甲、乙、丙素及熊果酸的量,对保肝丸的制剂质量提供保障。方法 采用ZORBAX SB-C18（150 mm×4.6 mm,5 μm）色谱柱；流动相为乙腈-0.1%磷酸水溶液（67:33）,体积流量1.0 mL/min；紫外检测波长为 210 nm；柱温 30 ℃；进样量10 μL。结果 五味子甲、乙、丙素及熊果酸的最低检测质量浓度分别为0.016、0.019、0.020、0.025 mg/L,线性范围分别为3.906～250.000、5.323～340.000、3.225～205.000、5.323～340.000 mg/L。供试样品中五味子甲素、五味子乙素、五味子丙素及熊果酸的平均回收率分别为100.79%、101.09%、101.26%、101.16%；精密度RSD 分别为1.76%、1.69%、1.80%、1.86%；重复性试验RSD 分别为1.77%、1.66%、1.49%、1.56%；稳定性试验分别为1.61%、1.39%、1.60%、1.56%。保肝丸（0.560 mg）含五味子甲、乙、丙素及熊果酸平均量分别为0.444、1.066、0.3125、1.068 μg/丸。结论 该方法简便、灵敏度高、重复性好、回收率高,是检测五味子甲、乙、丙素及熊果酸质量浓度的可信方法。

Objective To establish an RP-HPLC method for determining the contents of deoxyschizandrin, schisandrin b, schisandrin c, and ursolic acid in Baogan Pill, and to provide the quality guarantee for Baogan Pill. Methods Agilent Zorbax SB-C18 (150 mm × 46 mm, 5 μm) column was used. Acetonitrile and 0.1% phosphoric acid water solution was used as mobile phase, the volume flow was at 1.0 mL/min; Ultraviolent wavelength was 210 nm; Column temperature was at 30 ℃, and injection volume was 10 μL. Results The lowest detection limits in deoxyschizandrin, schisandrin b, schisandrin c, and ursolic acid respectively were 0.016, 0.019, 0.020, and 0.025 mg/L, the linear ranges respectively were 3.906—250.000, 5.323—340.000, 3.225—205.000, and 5.323—340.000 mg/L. The average recoveries of deoxyschizandrin, schisandrin b, schisandrin c, and ursolic acid in Baogan Pill respectively were 100.79%, 101.09%, 101.26%, and 101.16%; The precision RSD values were 1.76%, 1.69%, 1.80%, and 1.86%, respectively; The repeatability RSD values were 1.77%, 1.66% 1.49% and 1.56%, respectively; The stability RSD values were 1.61%, 1.39%, 1.60%, and 1.56%, respectively. The average amounts of deoxyschizandrin, schisandrin b, schisandrin c, and ursolic acid in the selected samples per pill were 0.444, 1.066, 0.3125, 1.068μg, respectively. Conclusion The method is believable for determining the contents of deoxyschizandrin, schisandrin b, schisandrin c, and ursolic acid with good simplicity, sensibility, repeatability, and recovery rate.

天津市应用基础与前沿技术研究计划（14JCYBJC24800）