Dissolution of Baicalin and Berberine Hydrochloride in Sanhuang Tablets from Different Pharmaceutical Factories

Objective To establish a method for determining the dissolution of baicalin and berberine hydrochloride in Sanhuang Tablets from different pharmaceutical factories,and research their dissolution behavior.Methods The contents of baicalin and berberine hydrochloride were determined by high performance liquid chromatography.The Grace-C18(4.5 mm×250 mm,5 μm)column was used,the mobile phase was methanol-acetonitrile-0.025 mol/L phosphoric acid(with triethylamine to adjust pH=3.0±0.1)=(25∶20∶55),the column temperature was set at 30 ℃,the detection wavelength was 265 nm,and flow velocity was 0.8 ml/min.The determination conditions of dissolution were selected;accumulation dissolution curves were calculated,drawn and compared by similarity factor values(f2),and the model simulation was done.Results The determination conditions of dissolution included paddle method with the rotating speed of 100 r/min and 0.1 mol/L hydrochloric acid plus 0.5% sodium dodecyl sulfate as dissolution medium.The results of determination showed that most of f2 values of baicalin and berberine hydrochloride dissolution curves of Sanhuang Tablets from different pharmaceutical factories were less than 50.The dissolution model simulations of this two components were not uniform.Conclusion There is significant difference in baicalin and berberine hydrochloride dissolution among Sanhuang Tablets from different pharmaceutical factories.It may result from different process of different factories.The dissolution of the main components should be added to the quality control systems of Chinese patent medicines,and an appropriate dissolution mechanism model should be sought to describe the dissolution behavior of traditional Chinese medicine.