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目的:建立通便灵胶囊的质量标准。方法:采用薄层色谱法对通便灵胶囊中的当归进行薄层色谱鉴别;采用高效液相色谱法对番泻叶中的大黄酸含量进行测定。结果:薄层定性鉴别色谱斑点清晰,分离度良好,阴性液无干扰;以高效液相色谱法测定本品中的大黄酸含量,大黄酸在0.1818~0.9090μg范围内呈现良好的线性关系。该方法的精密度、稳定性、重复性良好,加样回收率平均为99.15%,RSD为1.50%。结论:本试验所确立的质量分析方法稳定可靠,重复性好,可作为通便灵胶囊的质量标准。
Objective: To establish the quality standard of Tonglingling Capsules. Methods: Thin-layer chromatography was used to identify the Angelica sinensis in Tung-ling capsules. HPLC was used to determine the content of rhein in Senna leaves. RESULTS: The identification of chromatographic spots was clear and the chromatogram spots were clear. The negative liquid had no interference. The determination of rhein content in the product by high performance liquid chromatography showed that the rhein showed good linearity in the range of 0.1818-0.9090 μg. The precision, stability, and repeatability of the method are good. The average recovery of the sample is 99.15% and the RSD is 1.50%. Conclusion: The quality analysis method established in this experiment is stable, reliable, and reproducible, and it can be used as the quality standard for Tongfangling capsules.