清咽片质量控制研究

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。

Quality control of Qingyan Tablets

Objective To establish the quality standard for Qingyan Tablets. Methods Broneolum Syntheticum was identified by thin-laver chromatography （TLC）; Gallic acid was determined by HPLC. The chromatographic separation was achieved on Kromasil C18 column （250 mm×4.6 mm, 5 μm） with acetonitrile-0.1% phosphoric acid （1：99） water solution containing 0.1% triethylamine as mobile phase, the flow rate was 1 mL/min, and the detection wavelength was set at 273 nm. Results TLC spots developed were fairly clear and the blank test showed no interference; The calibration curve was linear within the range of 0.007—0.035 μg （r = 0.999 9）; The average recovery rate was 98.83%, and the RSD value was 1.34% （n = 6）. Conclusion The established method is accurate and has the advantages of simple operation with strong specificity and reproducibility, and could be used for the quality control of Qingyan Tablets.