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目的建立清咽利喉胶囊(丁香、甘草、诃子等)的质量标准。方法采用薄层色谱法对处方中丁香、冰片、甘草、诃子予以鉴别;丁香酚、甘草酸的定量测定采用高效液相色谱法。应用Diamonsil C18(4.6 mm×250 mm,5μm)色谱柱,丁香酚以甲醇-0.14%磷酸溶液(65∶35)为流动相,体积流量为1 mL/min,检测波长为280 nm,柱温为30℃;甘草酸以甲醇-0.2 mol/L醋酸铵溶液-冰醋酸(67∶33∶1)为流动相,体积流量为1 mL/min,检测波长为250 nm,柱温为30℃。结果薄层色谱检出了丁香、冰片、甘草、诃子,特征斑点分离清晰,阴性对照无干扰。丁香酚在0.248～1.490μg范围内,与峰面积具有良好的线性关系,相关系数为0.999 9;平均回收率为98.27%,RSD为1.06%(n=9)。甘草酸在0.098 5～0.344 6μg范围内,与峰面积具有良好的线性关系,相关系数为0.999 8;平均回收率为98.53%,RSD为1.09%(n=9)。结论该方法灵敏准确、专属性强、重复性好,可用于清咽利喉胶囊的质量控制。
Objective To establish the quality standard of Qingyan Liyao capsule (clove, licorice, myrobalan, etc.). Methods TLC, TLC, glycyrrhiza and Myrobalan were identified. The eugenol and glycyrrhizic acid were determined by HPLC. Diamonsil C18 column (4.6 mm × 250 mm, 5 μm) was used. The eugenol was eluted with methanol-0.14% phosphoric acid solution (65:35) at a flow rate of 1 mL / min and the detection wavelength was 280 nm. 30 ℃. Glycyrrhizic acid was eluted with methanol-0.2 mol / L ammonium acetate solution-acetic acid (67:33:1) at a flow rate of 1 mL / min. The detection wavelength was 250 nm and the column temperature was 30 ℃. Results TLC was detected cloves, borneol, licorice, Myrobalan, characteristic spots clear separation, negative control without interference. The eugenol had a good linear relationship with the peak area in the range of 0.248-1.490μg, the correlation coefficient was 0.999 9, the average recovery was 98.27% and the RSD was 1.06% (n = 9). Glycyrrhizic acid has a good linear relationship with the peak area in the range of 0.098 5-0.384 4 μg with a correlation coefficient of 0.999 8 and an average recovery of 98.53% with a RSD of 1.09% (n = 9). Conclusion The method is sensitive, accurate, specific and reproducible. It can be used for quality control of Qingyan Liyao capsule.