Studies On The Extraction Of Oxymatrine And The Preparations Of Its Film-coated Tablets

Oxymatrine has been main obtained from the Chinese drug Sophora alopecuroides,kuh seng,Sophora tonkinensis Gapnep,Radix Sophorae Subprostrata,In clinic,It is used in acute and chronic hepatitis and malignancy. Oxymatrine film-coated tablets has its strongpoint,so it is nessesary to study the progress of oxymatrine tablets preparations。In the study, we used roots of SoPhora aloPecuroides L.which was producted in Shaanxi and Gansu as raw material to study extraction efficiency of total alkaloid and oxymatrine,we determined the optimum extracting solvent and technological conditions. By studying the method of concertrating extraction liquids,we determined the method of alkaloid with water extracting(dippded in 0.5 times amount of 0.5% H₂SO₄ for 2h, then 4/3/2.5 times amount of water in 75±5℃,refluxing and extracting for 3 times,2h each time.),chloroform extraction (chloroform extracting for 6 times, then extracting oxymatrine from chloroform layer with 8% HCL , basifying the HCL layer to PH10-11 with NaOH ,in the end ,we can get the mixture containing oxymatrine),recrystallization of SoPhora aloPecuroides L and oxygenation of it (28% H₂O₂ dissolving SoPhora aloPecuroides L in 50℃a nd making it react in 60℃) . Using the method ,we can get high purification matrine and oxymatrine from. Sophora alopecuroides L. Purification exceeded 98%.In the study,Thin Layer Chromatography (TLC) and High Performance Liquid Chromatography (HPLC) were used to identify the quantitative analysis of crude pigment of Alkaloid Constituenis and oxymatrine crystals. The condition of HPLC is as follows:the solvent is methanol-- NaH₂PO₄ solution—NaCLO4(15ml:85ml:0.5g) , the chromatogram columniation is C₈(5um 4.6mm×150mm),the length of wave is 215nm ,the number of boad is below 6000 ,the volum of injection is between 0.021-10.36ug.This method is of more accuracy then tradtional method .In the studying, progress of oxymatrine tablets preparations and the quantity standard, We study on its film-coated tablets preparations,the quantity standard and stability. The results show that the selected formulation and technology are stable and practical to prepare.