水飞蓟素(益肝灵)片剂溶出速度的研究——水飞蓟素及其固体分散物片剂溶出考察  

Study on Dissolution Rate of Silymarin(Yiganling) Tablets Ⅰ.Dissolution Investigation of Silymarin and Its Solid Dispersion Tablets

作　　者：陈大为[1] 陈星灿[1] 范晓文[1] 刘军 

机构地区：[1]沈阳药学院,110015 [2]广州兴华制药厂

出　　处：《中成药》1992年第8期3-5,共3页Chinese Traditional Patent Medicine

摘　　要：实验考察了国产6个厂家益肝灵片剂及德国MADAUS药厂利肝隆片剂的溶出速度,结果表明30min益肝灵溶出均低于30％,利肝隆为50％;120min最大溶出益肝灵不超过43％,利肝隆约55％。表明水飞蓟素片溶出缓慢及生物利用度较差。分别制备水飞蓟素PEG熔融物,PVP共沉淀物及β-CD包合物,溶解度分别提高37、60及27倍,其相应片剂溶出速度T_(50)为14、11及20min,120min最大溶出达80～103％左右。通过uv、IR及TLC鉴定固体分散物中水飞蓟素结构未发生改变,偏光显微照相表明水飞蓟素结晶度下降,分散度增加。The dissolution rates of Yiganling Tablets produced by 6 pharmaceutical factories of China and Liganlong Tablets by MAOAUS Factory in German were investigated. As a result, after 30min, the dissolution of all Yiganling is below 30％ and that of Liganlong is 50%. After 120min, the largest dissolution of the former isn't over 43%, and that of the later is about 55％, which indicates that silymarin tablets dissolve more slowly and their bioavailability is lower. The dissolubility can be raised 37, 60 and 27 times, respectively if the silymarin was made into PEG fusion) PVP coprecipitation or β-CD inclusion compound. The disolution rate (T_(50)) of correspording tablets are 14, 11 and 20min. The largest dissolution after 120min reaches about 80%-103％. There isn't any change observed in the structure of silymarin in solid dispersion when it was identified with UV, IR and TLC. The micropolariscope photograph shows the crystal degree decreased and the dispersity increased.

关 键 词：水飞蓟素 片剂 溶出度 

分 类 号：R286.0[医药卫生—中药学]