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目的:建立清热养阴除湿丸的质量标准。方法:采用薄层色谱法对制剂中虎杖、桂枝和连翘进行定性鉴别;采用高效液相色谱法对制剂中当归的有效成分阿魏酸进行含量测定:色谱条件:Agilent Eclipse XDB-C_(18)色谱柱;乙腈-0.1%磷酸溶液(19∶81)为流动相,流速:1.0m L/min;柱温:室温;检测波长:320nm。结果:桂枝、虎杖和连翘的薄层色谱图斑点清晰、阴性无干扰。阿魏酸在0.031872-1.91232μg范围内线性关系良好,平均加样回收率98.97%,RSD为1.25%(n=6)。结论:该方法准确易行,重现性好,可用于清热养阴除湿丸的质量标准控制。
Objective: To establish the quality standard of Qingre Yangyin Dehuan Pill. Methods: TLC and HPLC were used to identify Polygonum cuspidatum, Cassia twig and Forsythia suspense. High performance liquid chromatography (HPLC) was used to determine the content of ferulic acid in Angelica sinensis. Chromatographic conditions: Agilent Eclipse XDB-C_ 18) column; acetonitrile-0.1% phosphoric acid solution (19:81) as mobile phase, flow rate: 1.0 m L / min; column temperature: room temperature; detection wavelength: 320 nm. Results: Guizhi, Polygonum cuspidatum and forsythia thin layer chromatography spots clear, negative non-interference. Ferulic acid showed good linearity in the range of 0.031872-1.91232μg with an average recovery of 98.97% and a RSD of 1.25% (n = 6). Conclusion: The method is accurate and reproducible, and can be used for the quality control of Qingre Yangyin Dehuan Pill.