通便灵胶囊质量标准的研究

Study on Quality Standard of Tongbianling Capsules

目的:建立通便灵胶囊的质量标准。方法:以番泻叶、当归为对照药材进行薄层鉴别,采用高效液相色谱法进行含量测定。结果:大黄酸的平均加样回收率为97.16%,RSD=2.23%(n=6)。薄层色谱斑点清晰,阴性对照无干扰,专属性强。结论:该方法结果准确,重复性好,可作为该制剂的质量控制指标。

Objective ：To establish the quality standard of Tonghianling Capsules. Methods：Tongbianling Capsules were identified by thin layer chromatography using Senna Leaf and Chinese Angelica as reference substances. The contents were determined by high performance liquid chromatography. Results：The average recovery of Rhein was 97.16% ,and RSD was 2.23% （n = 6）. Thin layer chromatograph spots were clear. The negative sample had no interference. The Specificity was good. Conclusion： This method is accurate, and it has good repeatability and could be used for the quality control of this preparation.