Study on Quality Standard of Danzhi Qranules

OBJECTIVE To establish the quality standard of Danzhi granules. METHODS Gardeniae Fructus, Paeoniae Radix Alba and Scutellariae Radix were identified by TLC. The contents of paeoniflorin and salvianolic acid B were determined by HPLC. The chromatographic column was Agilent C₁₈(250 mm×4.6 mm, 5 μm)_.The mobile phase was acetonitrile(A)-0.1% phosphoric acid solution(B) and gradient elution was performed. The detection wavelength was 230 nm. The flow rate was 1.0 mL·min^-1. The column temperature was 25℃. The injection volume was 10 μL. RESULTS TLC spots of geniposide, paeoniflorin and baicalin were clear with good separation. There was a good linear relationship between the concentration and the chromatographic peak area. The liner ranges were 6.1-54.9 μg·mL^-1 for paeoniflorin(r=0.999 5). The liner ranges were 6.8-61.2 μg·mL^-1 for salvianolic acid B(r=0.999 9). The average recoveries of paeoniflorin was 99.08% and RSD was 1.53%. The average recoveries of salvianolic acid B was 99.39% and RSD was 0.89%. CONCLUSION The method is sensitive, specific and reproducible, which can be used for the quality control of Danzhi granules.