仙灵骨葆胶囊中丹参酮Ⅱ_A溶出度测定方法研究  

Dissolution of tanshinone Ⅱ_A from Xianling Gubao capsule

作　　者：杜守颖[1] 陈雯[1,2] 吴清[1] 武慧超[1] 陈晓兰[1] 

机构地区：[1]北京中医药大学中药学院,北京100102 [2]中国中医科学院广安门医院,北京100053

出　　处：《中国中药杂志》2010年第13期1706-1709,共4页China Journal of Chinese Materia Medica

基　　金：国家"十一五"科技支撑计划项目(2006BA106A17);国家"重大新药创制"科技重大专项(2009ZX09502-008);国家"重大新药创制"科技重大专项(2009ZX09308-003)

摘　　要：目的:建立仙灵骨葆胶囊中丹参酮ⅡA的体外溶出测定方法,对新型仙灵骨葆胶囊与仙灵骨葆胶囊中丹参酮ⅡA的溶出情况进行比较。方法:采用小杯法,转速100 r.m in-1,以6种不同溶液为溶出介质,HPLC法测定仙灵骨葆胶囊中丹参酮ⅡA在不同溶出介质中的体外溶出度,计算累积溶出百分率,采用相似因子(f2)进行释放曲线的相似性比较,对溶出曲线进行多种数学模型拟合,计算溶出参数。结果:以pH 7.6的磷酸盐缓冲液+4.0%胆酸作为仙灵骨葆胶囊中丹参酮ⅡA的溶出介质时,累积溶出百分率最高;新型仙灵骨葆胶囊与仙灵骨葆胶囊中丹参酮ⅡA的溶出曲线相似因子f2小于50。结论:不同工艺制备的仙灵骨葆胶囊丹参酮ⅡA的溶出度差异较大。新型仙灵骨葆胶囊丹参酮ⅡA的溶出速度快,累积溶出百分率高。Objective：To establish a method to determine the dissolution of Tanshinone IIA in Xianling Gubao capsules,and compare the dissolution of Xianling Gubao capsules prepared by different processes.Method：The small cup method was used at a rotary speed of 100 r·min-1,the dissolubility was inspected in the following 6 mediums：①water;②0.1 mol·L-1 hydrochloric acid solution;③pH 6.8 phosphate buffer;④pH 6.8 phosphate buffer solution ＋ 0.5% cholic acid;⑤pH 6.8 phosphate buffer solution ＋ 1.0% cholic acid;⑥pH 7.6 phosphate buffer solution ＋ 4.0% cholic acid.A HPLC method was used to determine the dissolution samples of tanshione ⅡA in different dissolution mediums.The accumulative dissolution percentages were calculated,and the resemblance of release curves were compared by similarity factors（f2）.Result：The accumulative dissolution percentage was the highest while pH 7.6 phosphate buffer solution ＋ 4.0% cholic acid was used as medium.The similarity factor values（f2）of tanshinone ⅡA dissolution curves of different preparation processes of Xianling Gubao capsules were all less than 50.Conclusion： There is significant difference in tanshinone ⅡA dissolution between Xianling Gubao capsules of different preparation processes.The accumulative dissolution percentages of the tanshinone ⅡA in new Xianling Gubao capsules is higher than that in the capsules prepared by other preparation processes.

关 键 词：仙灵骨葆胶囊 丹参 溶出度 相似因子 

分 类 号：R286.0[医药卫生—中药学]