目的：建立通便清火丸薄层鉴别和药效成分含量测定方法，提升质量标准。方法：采用薄层色谱法，以黄芩苷、欧前胡素和绿原酸作为对照品进行薄层鉴别试验。采用高效液相色谱法，以黄芩苷、欧前胡素和绿原酸作为指标成分进行定量分析。结果：薄层色谱法斑点清晰且分离度和专属性好。黄芩苷、欧前胡素和绿原酸的专属性好，分别在0.075~0.375 mg·mL-1、0.5625 ~ 3.188 μg·mL-1、0.49~3.43 μg·mL-1范围内呈现良好的线性关系，重复性的RSD（相对标准偏差）分别为0.51%、1.22%、1.60%，平均加样回收率和RSD分别为101.1%、112.4%、99.74%，并且各供试品溶液在配置后的6 h内呈现良好的稳定性。结论：本研究建立的方法快速简便、准确性高、重复性好，可为通便清火丸质量标准提升提供一定的科学依据。

Objective: To establish a method for the thin-layer identification and determination of the content of medicinal ingredients in Laxative and Fire-clearing Pills, and to improve the quality standard. Methods: Thin-layer chromatography (TLC) was used to identify baicalin, imperatorin and chlorogenic acid as the control products. High performance liquid chromatography (HPLC) was used for quantitative analysis of baicalin, imperatorin and chlorogenic acid as index components. Results: The thin-layer chromatographic method showed clear spots with good separation and specificity. Baicalin, imperatorin and chlorogenic acid showed good specificity with good linearity in the ranges of 0.075-0.375 mg·mL-1, 0.5625 ~ 3.188 μg·mL-1, and 0.49-3.43 μg·mL-1, respectively, and the precision (RSD) was 0.51%, 1.22%, and 1.60%, respectively, and the average dosing recovery rate is 101.1%, 112.4% and 99.74%, respectively, and the stability of each test solution was good within 6 h after preparation. Conclusion: The method established in this study is rapid, simple, highly accurate and reproducible, which can provide a scientific basis for improving the quality standard of Laxative and Fire-clearing Pills.

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] 内蒙古自治区自然科学基金面上项目(2019MS02013)*；内蒙古自治区留学人员创新创业启动支持计划(DC1900003107)