Study on Quality Standard for Fushiming Capsule / 中国药房

ABSTRACT

OBJECTIVE:To establish quality standard of Fushiming capsule. METHODS:TLC was used to qualitatively identify the ligustilide,aurantio obtusin,chrysophanol,fruit of Chinese wolfberry and Whitmania pigra,respectively. HPLC method was used to determine the contents of puerarin and ginsenosides Rb1. The determination was performed on Intersil C18 column with mobile phase consisted of acetonitrile-0.3% phosphoric acid(gradient elution)at flow rate of 1.0 mL/min;the detection wavlength was set at 203 nm,and column temperature was 25 ℃;the sample size was 10 μL. RESULTS:TLC spots of ligustilide,aurantio obtusin,chrysophanol,the fruit of C. wolfberry and W. pigra were clear and well separated without negative interference. The linear range of puerarin and ginsenoside Rb1were 10.56-337.92 μg/mL(r=0.999 7)and 17.80-569.70 μg/mL(r=0.999 6). The limits of quantitation were 2.20,1.86 μg/mL,and the limits of detection were 0.12,0.13 μg/mL,respectively. RSDs of precision,stability and reproducibility tests were lower than 2.0%. The recoveries were 95.65%-99.66%(RSD=1.45%,n=6) and 96.95%-98.52%(RSD=0.77%,n=6),respectively. CONCLUSIONS:Established quality standard can be used for the quality control of Fushiming capsule.