Study on Quality Standard of Prostatitis Capsules
10.6039/j.issn.1001-0408.2017.15.25
- VernacularTitle:普乐士泰胶囊的质量标准研究
- Author:
Lüping YE
;
Bin BIN
;
Minyang GONG
;
Chunli TANG
;
Ruqing MA
- Keywords:
Prostatitis capsules;
Quality standard;
TLC;
Leonurine;
HPLC
- From:
China Pharmacy
2017;28(15):2104-2107
- CountryChina
- Language:Chinese
-
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.