OBJECTIVE: To establish the quality standard for Tongkuaixiao oral liquid. METHODS: TLC was used for the qualitative identification of Prunella vulgaris and Polygonum bistorta in the preparation; HPLC was used for the content determination of morphine: the column was Kromsail C18 with mobile phase of acetonitrile-0.1% phosphoric acid (15 ∶ 85,V/V) (each 100 mL added sodium heptanesulfonate 0.1 g) at a flow rate of 1.0 mL/min, detection wavelength was 220 nm, column temperature was 25 ℃, and injection volume was 10 μL. RESULTS: The TLC spots of P. vulgaris and P. bistorta were clear and well-separated, negative control without interference. The linear range of morphine was 15.13-242.08 μg/mL(r=0.999 9); RSDs of precision, stability and reproducibility tests were lower than 2.0%; recovery was 97.80%-102.10% (RSD=1.57%,n=6). CONCLUSIONS: The establish standard can be used for the quality control of Tongkuaixiao oral liquid.