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目的建立清咽片的质量控制方法。方法采用薄层色谱法对冰片进行定性鉴别;采用高效液相色谱法对没食子酸进行定量测定。色谱柱为翡纳米公司Kromasil C18柱(250mm×4.6mm,5μm),以乙腈-含0.1%三乙胺的0.1%磷酸水溶液(1∶99)为流动相,体积流量为1mL/min,检测波长为273nm。结果薄层色谱鉴别斑点清晰,阴性样品无干扰;定量测定中没食子酸进样量在0.007μg～0.035μg与峰面积线性关系良好(r=0.9999);平均回收率为98.83%,RSD为1.34%(n=6)。结论建立的方法操作简单、准确、专属性和重复性好,可用于该制剂的质量控制。
Objective To establish a quality control method for Qingyan Tablet. Methods Thin layer chromatography was used for the qualitative identification of borneol. The content of gallic acid was determined by high performance liquid chromatography. The column was a Kromasil C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-0.1% phosphoric acid solution (1:99) containing 0.1% triethylamine at a volume flow rate of 1 mL / min. The detection wavelength 273 nm. Results The results showed that the spots were clear and the negative samples were identified by TLC. There was a good linear relationship between the concentration of gallic acid and 0.007μg ~ 0.035μg (r = 0.9999), the average recovery was 98.83% and the RSD was 1.34% (n = 6). Conclusion The established method is simple, accurate, specific and reproducible and can be used for the quality control of the preparation.