清肺膏的质量标准研究

Study on the quality standards of Qingfei paste

目的建立清肺膏的质量标准。方法采用薄层色谱法对清肺膏处方中大黄、黄柏、瓜蒌皮进行定性鉴别,采用高效液相色谱法检测制剂中苦杏仁苷的含量。结果本品薄层色谱法定性鉴别薄层色谱斑点清晰,专属性强,重复性好。苦杏仁苷检测质量浓度线性范围为13.06-391.80μg/ml(r=0.999 9);检测限为0.13μg/ml、定量限为2.61μg/ml;平均加样回收率为97.55%(RSD=1.09%)。结论该法简单、专属性强、灵敏度高、定量准确,适用于清肺膏的质量控制。

Objective To develop a method for quality control of Qingfei paste. Methods The contents of Rhei Radix Et Rhizoma, Phellodendri Chinensis Cortex and Trichosanthis Pericarpium in Qingfei paste were identified by thin layer chromatography （TLC）, and the content of amygdalin was detected by HPLC. Results TLC spots were clear and specific, with high specificity and good repeatability. The calibration curve of amygdalin was linear in the range of 13.06 -391.80 μg/ml（ r = 0. 999 9）. The limit of detection（LOD） was 0. 13 μg/ml, and the limit of quantitation was 2. 61μg/ml. The average extraction recovery of amygdalin was 97. 55% with RSD of 1.09%. Conclusion The method is simple with high specificity, sensitivity and accuracy, and it is suitable for the quality control of Qingfei paste.