Abstract: Objective： To discuss the quality standard of fu jie shu liniment.Methods：The effective ingredients of traditional Chinese medicine in the prescription were extracted for fu jie shu liniment by decoction extraction method and distillation concentration method，and fu jie shu liniment was prepared. The thin layer chromatography(TLC) method was used to identify phellodendron and sophora in the lintment.High performance liquid chromatography(HPLC) method was used for determination of berberine hydrochloride content as effective ingredient in the lintment. Diamonsil C18 ODS column (4.6 mm×200 mm， 5 μm) was used with a mobile phase of methanol-triethylamine-water (80∶20∶10) at a flow rate of 1.0 mL·min-1.The column temperature was 30 ℃.The detection wavelength was set at 346 nm， and the injection volume was 10 μL. Results：The linear relationship between berberine hydrochloride detection concentration in the range of 8.00~92.00 mg·mL-1（r=0.9998） was good.The relative standard deviation （RSD） of the nine replicates was 1.51%， the detection limit was 0.1 μg， and the average recovery was 99.97%.Fu jie shu liniment preparation process was stable， phellodendron and sophora had clear spots on the thin layer in the lintment，and negative control was without interference.The established HPLC method could be used for the quality control of fu jie shu liniment.Conclusion： Determination of berberine hydrochloride in liniment by HPLC is efficient， convenient and accurate. The formulation is reasonable，the preparation process is stable， and the quality control method is effective.