硝酸异山梨酯固体分散体的制备及其体外溶出特性研究  

Studies on preparation and in vitro evaluation of isosorbide dinitrate solid dispersion

作　　者：段雪艳[1] 刘清飞[2] 苏强[1] 毕开顺[1] 王义明[2] 罗国安[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]清华大学生命科学与医学研究院,北京100084

出　　处：《中国新药杂志》2008年第8期682-684,696,共4页Chinese Journal of New Drugs

基　　金：国家自然科学基金资助项目(30500666);国家十一五科技支撑计划资助项目(2006BAI08B04-01)

摘　　要：目的:采用固体分散技术,提高硝酸异山梨酯在水中的溶解度和体外溶出速率。方法:以聚乙二醇6000(PEG6000)为载体,熔融法制备硝酸异山梨酯的固体分散体。考察其体外特性,并采用X-射线粉末衍射、差示扫描量热法(DSC)和红外光谱法鉴别药物在固体分散体中的存在状态。结果:固体分散体能加快药物的溶出速率,最佳比例为1∶7。硝酸异山梨酯在PEG6000的固体分散体中以微细结晶存在。结论:硝酸异山梨酯-PEG6000(1∶7)固体分散体增加硝酸异山梨酯溶出度的效果显著。Objective：To improve the solubility and in vitro dissolution of isosorbide dinitrate（ISDN） solid dispersion. Methods：The solid dispersion was prepared by the melting method with PEG6000 as carrier,and the in vitro dissolution characteristics of ISDN-PEG6000 solid dispersion was determined by IR spectra, DSC and X-ray powder diffractography. Results：The in vitro dissolution rates of ISDN solid dispersion were faster than ISDN. In brief,the best proportion was 1 ： 7. ISDN existed as fine crystalline in ISDN-PEG6000 solid dispersion. Conclusion：ISDN-PEG6000 solid dispersion could improve the dissolution of ISDN significantly.

关 键 词：硝酸异山梨酯 固体分散体 溶解度 溶出速率 

分 类 号：R972.3[医药卫生—药品]