目的:建立金芍胶囊的质量标准。方法:采用TLC法鉴别方中赤芍、延胡索、黄柏、莪术、苍术、当归、香附;采用HPLC法测定盐酸小檗碱、芍药苷的含量。结果:在TLC色谱中可检出赤芍、延胡索、黄柏、莪术、苍术、当归、香附的特征斑点,清晰,易于观察;盐酸小檗碱在0.084～2.122μg范围内线性关系良好(r=0.999 9),平均回收率为99.06%,RSD=1.33%(n=6);芍药苷在0.079～1.983μg范围内线性关系良好(r=0.999 8),平均回收率为98.94%,RSD=1.88%(n=6)。结论:方法简便、准确、稳定且无干扰,可作为该制剂的质量控制方法。 Objective: To establish the quality standard of Jinshao Capsule. Methods: The prescriptions of Radix Paeoniae, Rhizoma Corydalis, Cortex Phellodendri, Rhizoma Curcuma, Cangzhu, Angelica and Cyperus rotundus were identified by TLC. The content of berberine hydrochloride and paeoniflorin were determined by HPLC. Results: The characteristic spots of Radix Paeoniae, Rhizoma Corydalis, Cortex Phellodendri, Rhizoma Curcumae, Rhizoma Corydalis, Radix Angelicae Sinensis and Rhizoma Corydalis were detected by TLC, which were clear and easy to observe. Berberine hydrochloride had a good linear relationship in the range of 0.084-2.122μg (r = 0.999 9). The average recovery was 99.06% and the RSD was 1.33% (n = 6). The linear range of paeoniflorin was 0.079-1.983 μg (r = 0.999 8). The average recovery was 98.94% % (n = 6). Conclusion: The method is simple, accurate, stable and non-interfering and can be used as a quality control method for this preparation.