To establish the quality control standards of Qingshi Zhiyang Ointment.Methods:The quality standard was tested on the raw and supplementary material of Qingshi Zhiyang Ointment,including the amount of drug loading,particle size and microbial limit.Indigo Naturalis,Radix Sophorae Flavescentis and Cortex Phellodendri in Qingshi Zhiyang Ointment were detected by thin layer chromatography.The mobile phase was methanol-water (65:35),the detection wavelength was 285 nm,and the flow rate was 1.0 mL/min.The mobile phase consisted of Waters Symmetry Shiled-RP18 column (150 mm×4.6 mm,5 μm),and the column temperature was maintained at 25 ℃.Results:The raw materials of Qingshi Zhiyang Ointment,the batches of three batches of calcite,the particle size and the microbial limit were consistent with the relevant provisions of the 2010 edition of the Chinese Pharmacopoeia.The thin-layer chromatograms of Indigo Naturalis,Radix Sophorae Flavescentis and Cortex Phellodendri in Qingshi Zhizhi ointment were obvious,and the negative control had no interference.There was a good linear relationship between the concentration of indigo and indirubin,and the peak area of them were in the range of 2.35-4.7 μg (r=0.9998) and 0.00832-0.2912 μg (r=0.9996).Conclusion:The method of this experiment is simple,accurate and reliable,which can be used as a quality control method of the preparation.