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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。
Objective To establish a method for the evaluation of in vitro release of nimesulide and investigate the correlation in vitro and in vivo. Methods The spinach method was used to determine the in vitro release of nimesulide in Tris-HCl buffer at pH 9.0. The plasma concentration of nimesulide in vitro was determined by LC-MS / MS and the Wagner-Nelson method Nimesulide sustained release tablets in vitro and in vivo relevance. RESULTS AND CONCLUSION: The regression equation of in vitro cumulative release (Y) and absorption fraction (X) was Y = 2.683X-40.21 (r = 0.9618), which showed that nimesulide sustained- .