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目的制定肃清丸质量控制标准。方法采用薄层色谱法对肃清丸中的金银花、玄参、当归、黄芪、地榆、甘草、连翘进行定性鉴别,采用高效液相色谱法测定肃清丸中绿原酸的量。色谱柱为LunaC18柱(250mm×4.6mm,5μm),流动相为乙腈-0.4%磷酸溶液(10:90),柱温30℃,体积流量为1.0mL/min,检测波长为328nm。结果金银花、玄参、当归、黄芪、地榆、甘草、连翘薄层色谱斑点清晰,重现性好,无干扰;绿原酸在5.4～54.0μg/mL线性关系良好,平均回收率为99.77%,RSD=1.59%(n=6)。结论所建立的定性和定量方法结果准确、可靠、重现性好,可用于肃清丸的质量控制。
Objective To establish the quality control standard of Suqing pill. Methods TLC was used to qualitatively identify the honeysuckle, Radix Scrophulariae, Radix Angelicae Sinensis, Radix Astragali, Burnet, licorice root and Forsythia suspense, and the content of chlorogenic acid in Radix Astragali was determined by HPLC. The column was a Luna C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-0.4% phosphoric acid solution (10:90). The column temperature was 30 ℃, the volume flow rate was 1.0 mL / min and the detection wavelength was 328 nm. Results The TLC spots of honeysuckle, Scrophulariaceae, Angelica, Astragalus, Burnet, licorice and forsythia had clear spots with good reproducibility and no interference. The linearity of chlorogenic acid was 5.4 ~ 54.0μg / mL, with an average recovery of 99.77 %, RSD = 1.59% (n = 6). Conclusion The established qualitative and quantitative methods are accurate, reliable and reproducible, and can be used to eliminate the quality control of pills.