Study on quality standard of Sishen Pill / 中成药

ABSTRACT

AIM: To establish HPLC fingerprint of Sishen Pill and a determination of main component of Sishen Pills(Fructus Evodiae, Semen Myristicae, Fructus Psoraleae, etc.) by HPLC. METHODS: The samples were extracted with the solvent methanol. The separation was performed on YWG-C 18(4.6mm?250mm, 10?m) column with water- methanol-acetonitrile as a mobile phase gradient elution. The flow rate was 1.0mL?min -1, the column temperature was at 30℃ and the wavelength of UV detector was at 225nm. RESULTS: There are 21 higher peaks and 12 marker peaks in the fingerprint of eight batches of samples. For evodiamine, the regression equation was Y=147.37X+1186.32, r=0.9999, the liner range was from 5 to 1000?g?mL -1 and the recovery was 99.83%. For rutaecarpin, the regression equation was Y=101.19X+279.81, r= 0.9999, the liner range was from 4.5 to 900?g?mL -1. The recovery was 98.72%. CONCLUSION: The quality standard of Sishen Pill was established firstly. It can be used for quality cantrol of Sishen Pill.