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目的建立止泻胶囊的质量标准。方法采用TLC鉴别止泻胶囊中黄连和白芍;HPLC法测定止泻胶囊中黄连主要成分小檗碱的含量。结果 TLC中,供试品在与对照药材或对照品相应位置上出现相同颜色的斑点,阴性对照无干扰;HPLC中盐酸小檗碱浓度在2~100μg·ml-1范围内线性关系良好(r=0.9997),平均回收率为103.21%,RSD为1.22%(n=6)。结论本方法准确、可靠、重复性好,可作为该制剂的质量控制方法。
Objective To establish the quality standard of Zhixie capsule. Methods TLC and DGP were used to identify Zhixie capsule. HPLC was used to determine berberine content in Zhixie capsule. Results In TLC, the spots of the same color appeared on the corresponding position of the reference drug or reference substance, and the negative control had no interference. The concentration of berberine hydrochloride in HPLC ranged from 2 to 100 μg · ml-1 (r = 0.9997) with an average recovery of 103.21% and a RSD of 1.22% (n = 6). Conclusion The method is accurate, reliable and reproducible. It can be used as a quality control method for this preparation.