Study on Quality Standard of Compound Duzheng Tablets / 中国药房

ABSTRACT

OBJECTIVE:To establish the quality standard of Compound duzheng tablets. METHODS:TLC method was used for qualitative identification of Vitis davidii,Aralia chinensis,Acanthopanax senticosus and Panax notoginseng in the preparation. The contents of syringoside,oleanolic acid,ginsenoside Rg1,ginsenoside Rb1 and notoginsenoside R1 were determined by HPLC. The determination was performed on Inertsil ODS-SP C18 column with mobile phase consisted of acetonitrile-water(gradient elu-tion)at the flow rate of 1.0 mL/min. The detection wavelength was set at 215 nm,and the column temperature was 25 ℃. The sam-ple size was 10 μL. RESULTS:TLC spots of V. davidii,A. chinensis,A. senticosus and P. notoginseng were clear and well-separat-ed without interference from negative control. The linear ranges of syringoside,oleanolic acid,ginsenoside Rg1,ginsenoside Rb1 and notoginsenoside R1 were 0.056-0.337 μg(r=0.9998),0.022-0.130 μg(r=0.9999),0.030-0.182 μg(r=0.9995),0.010-0.061 μg(r=0.9998),0.038-0.226 μg(r=0.9999),respectively. RSDs of precision,stability and reproducibility tests were all lower than 3.0%. The recoveries were 100.55%-103.80%(RSD=2.0%,n=9),100.00%-104.56%(RSD=3.0%,n=9),97.06%-102.94%(RSD=2.1%,n=9)、97.06%-102.94%(RSD=2.0%,n=9),96.67%-100.00%(RSD=1.5%,n=9). CONCLUSIONS:Established standard can be used for the quality control of Compound duzheng tablets.