Study On The Preparation Technology And The Quality Control Of Shenbai Capsule

The Shenbai capsule is made from the extract of Radix Sophorae flavescentis and Cortex Phellodendri amurense. The processing method,chemical constituents,effect of pharmacology and clinical application of the two Chinese traditional medicines were summarized.The extraction technology of the effective components of the raw materials was studied by an orthogonal design using content of the major effective component berberine,oxymatrine and the weight of extract as markers, reviewing the ethanol concentration, the ethanol quantity, the extaction time and the extaction times.The optimal dosage proportion of Radix Sophora flavescentis and Cortex Phellodendri Amurense in Shenbai capsule was established through vitro antibacterial experiments.The preparation technology of Shenbai capsule was established.Reverse-phase HPLC methods have been developed for the determination of berberine, oxymatrine and matrine in raw materials, intermediates and Shenbai capsule. Based on the results, contents of berberine,oxymatrine and matrine were chosen as the quality control indices to the quality assessment of the raw materials, intermediate and Shenbai capsule.The stability test on Shenbai capsule was developed and the quality criterion of Shenbai capsule was established.