Study on Quality Standard of Chushi Pill / 中国药房

ABSTRACT

OBJECTIVE:To establish the quality standard of Chushi pill. METHODS:Microscopic identification and TLC were adopted for the qualitative identification of Cortex moutan,C. dictamni,Angelica sinensis,Rubia cordifolia and Gardeniae fructus in Chushi pill;HPLC was performed to determine the contents of paeonol and baicalin. It was performed on column of Kro-masil 100-5 C18 with mobile phase of methanol-water-phosphoric acid(47∶53∶0.2,V/V/V)at the flow rate of 1.0 ml/min,the detec-tion wavelength was 280 nm,the temperature was 25 ℃ and the volume was 10 μl. RESULTS:The microscopic identification showed microscopic characteristics of C. moutan and C. dictamni,and characteristics of A. sinensis,R. cordifolia and G. fructus were identified by TLC;the linear range of paeonol was 0.106 24-2.124 8 μg(r=0.999 9)and baicalin was 0.059 04-1.180 8 μg (r=0.999 9);RSDs of precision,stability and reproducibility tests were no more than 2.06%;average recoveries were respective-ly 101.56%(RSD=1.68%,n=9)and 100.16%(RSD=1.13%,n=9). CONCLUSIONS:The method is simple,accurate and re-producible,and can be used for the quantity control of Chushi pill.