目的 建立清咽片的質量控制方法。方法 采用薄層色譜法對冰片進行定性鑒別；采用高效液相色譜法對沒食子酸進行定量測定。色譜柱為翡納米公司Kromasil C₁₈柱（250 mm×4.6 mm，5 μm），以乙腈-含0.1%三乙胺的0.1%磷酸水溶液（1∶99）為流動相，體積流量為1 mL/min，檢測波長為273 nm。結果 薄層色譜鑒別斑點清晰，陰性樣品無干擾；定量測定中沒食子酸進樣量在0.007 μg～0.035 μg與峰面積線性關系良好（r＝0.999 9）；平均回收率為98.83%，RSD為1.34%（n＝6）。結論 建立的方法操作簡單、準確、專屬性和重復性好，可用于該制劑的質量控制。

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.