Abstract:
OBJECTIVE To establish the quality standard of Lixieling tablets.
METHODS Thin layer chromatography was used to identify Bistortae Rhizoma, Andrographis Herba and Sophorae Flavescentis Radix in Lixieling tablets. The components of andrographolium and matrine were determined by HPLC.
RESULTS The thin layer spots of Bistortae Rhizoma, Andrographis Herba and Sophorae Flavescentis Radix were clear, with good separation effect and repeatability. The linear relationship between andrographolide, neoandrographolide, 14-deoxygenated andrographolide, dehydrated andrographolide, sophorine, oxymatrine, sophorine and oxysophorine and their respective concentration ranges was good. The RSDs of instrument precision, repeatability, stability and recovery all met the requirements.
CONCLUSION The method is simple and reproducible, and can be used for the quality control of Lixieling tablets.