A scientific and perfect quality evaluation system for Moutan Cortex Formula Granules was established,including content determination method,characteristic chromatogram method and mass spectrometry method. The content of paeoniflorin and paeonol in Moutan Cortex Formula Granules was determined by high performance liquid chromatography( HPLC),and the average content was 1. 72% and 1. 42%,respectively. The characteristic chromatogram was used to characterize Moutan Cortex Formula Granules,which contained 7 characteristic peaks,namely gallic acid,p-hydroxybenzoic acid,oxypaeoniflorin,paeoniflorin,tetragalloyl glucose,1,2,3,4,6-penta-O-galloyl-β-D-glucose and paeonol. A total of 40 compounds in Moutan Cortex Formula Granules,including gallic acids,paeoniflorins,paeonols,flavonoids and benzoic acids,were identified by mass spectrometry. In this study,a variety of analytical methods were used to evaluate the quality system of Moutan Cortex Formula Granules,which could play a positive role in improving the level of quality evaluation and process quality control.
Keywords: Formula Granules; Moutan Cortex; characteristic chromatogram; content determination; mass spectrometry; paeoniflorin; paeonol.