OBJECTIVE: To establish the quality standard for Prostatitis capsules. METHODS: TLC method was performed to qualitatively identify Pseudostellaria heterophylla, Acortw tatarinowii,Sargentodoxa cuneata, Rubia cordifolia and Vaccaria segetalis in the preparation. HPLC method was adopted to determine the content of leonurine in the preparation. The determination was performed on Agilent Eclipse XDB-C18 column with mobile phase consisted of methanol-0.025 mol/L potassium dihydrogen phosphate (pH adjusted to 2.5)(24 ∶ 76,V/V) with phosphoric acidat the flow rate of 1.0 mL/min. The detection wavelength was set at 277 nm, and column temperature was 30 ℃. The sample size was 10 μL. RESULTS: The TLC spots of P. heterophylla, A. tatarinowii, S. cuneate, R. cordifolia, and V. segetalis were clear and well-separated without interference from negative control. The linear range of leonurine were 4.05-81.00 μg/mL(r=0.999 9). RSDs of precision, stability and reproducibility tests were all lower than 2.0%. The recovery was 98.47%-103.83%(RSD=2.04%,n=9). CONCLUSIONS: Established standard can be used for quality control of Prostatitis capsules.