Study on Quality Standard of Prostatitis Capsules / 中国药房

ABSTRACT

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 segeta-lis 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 phos-phate(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. tatari-nowii,S. cuneate,R. cordifolia,and V. segetalis were clear and well-separated without interference from negative control. The lin-ear range of leonurine were 4.05-81.00 μg/mL(r=0.9999). 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 quali-ty control of Prostatitis capsules.