Research on the Improvement of Quality Standard for ShutonganⅠGranule / 中国药房

ABSTRACT

OBJECTIVE:To establish the quality standard for ShutonganⅠgranule.METHODS:TLC was conducted for the qual-itative identification of Citrus aurantium and Forsythia suspensa. HPLC was conducted for the content determination of naringin in the preparation;the column was Agilent C18 with mobile phase of acetonitrile-water(2080,V/V)at a flow rate of 1.0 ml/min,the detection wavelength was 283 nm,the column temperature was 30 ℃,and the injection volume was 10 μl. HPLC was also used for the content determination of phillyrin;the column was Agilent TC-C18 with mobile phase of acetonitrile- water(2377,V/V)at a flow rate of 1.0 ml/min,the detection wavelength was 277 nm,the column temperature was 30 ℃,and the injection volume was 10 μl. RESULTS:The C. aurantium and F. suspensa of TLC showed clear spots and good separation. The linear range was 57.843-289.214 μg/ml for naringin(r=0.999 9)and 37.434-187.169 μg/ml for phillyrin(r=0.999 6);RSDs of precision,stability and reproducibility tests were less than 2%;recoveries were 97.20%-102.04%(RSD=1.7%,n=9)and 97.14%-102.27%(RSD=2.0%,n=9),respectively. CONCLUSIONS:The standard can be used for the quality control of ShutonganⅠgranule.