尼美舒利双层缓释片体外释放和体内外相关性研究  

Correlation between in vitro dissolution and in vivo absorption of nimesulide double-layer sustained release tablets

作　　者：白雪茜 杨美燕[1] 孟繁华[1] 范云周[1] 郭继芬[1] 高春生[1] 

机构地区：[1]军事医学科学院毒物药物研究所,北京100850 [2]延边大学药学院,吉林延吉133000

出　　处：《军事医学》2011年第10期776-779,共4页Military Medical Sciences

基　　金：国家科技重大专项资助项目(2009ZX09301-002);国家科技重大专项重大新药创制资助项目(2008ZXJ09010-001)

摘　　要：目的建立尼美舒利体外释放评价方法,并考察体内外相关性。方法采用转篮法,以pH 9.0的三羟甲基氨基甲烷缓冲液为释放介质,测定尼美舒利体外释放度;LC-MS/MS法测定犬体内血药浓度,应用Wagner-Nelson法评价尼美舒利双层缓释片体内外相关性。结果与结论测得的体外累计释放度(Y)与吸收分数(X)回归方程为:Y=2.683X-40.21(r=0.9618),表明尼美舒利双层缓释片体内外相关性良好。ObjectiveTo study the correlation between the in vitro dissolution and the in vivo absorption of nimesulide double-layer sustained release tablets.MethodsThe rotating basket method was used to determine in vitro release with pH 9.0 Tris-hydroxylmethyl aminomethane buffer as the release medium.The LC-MS/MS method was used to determine the plasma concentration of nimesulide in beagle dogs.The in vivo absorption percentage was calculated by Wagner-Nelson method.Results and ConclusionThe regressive equation was obtained by plotting the release rate to the input function： Y=2.683X-40.21（r=0.9618）,showing a fine correlation between in vitro dissolution and in vivo absorption of nimesulide double-layer sustained release tablets.

关 键 词：尼美舒利 双层缓释片 释放度 体内外相关性 

分 类 号：R96[医药卫生—药理学]