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萘普生钠片溶出度测定及体内外相关性评价
引用本文:乐健,刘茜,石劲敏,陈桂良.萘普生钠片溶出度测定及体内外相关性评价[J].药学实践杂志,2008,26(3):211-213.
作者姓名:乐健  刘茜  石劲敏  陈桂良
作者单位:上海市食品药品检验所,上海,201203
摘    要:目的:进行萘普生钠片体外溶出度的测定及体内外相关性评价.方法:按USP29版萘普生钠片溶出度测定法测定萘普生钠片体外溶出度,用HPLC法测定萘普生钠片在人体内的血药浓度,并用BAPP2.0程序进行拟合.结果:以体内吸收分数(F)对体外累积溶出率(X)进行线性回归,得方程F=0.330 3X 0.699 8(r=0.991 5),体内吸收分数与体外累积溶出率具有良好的相关性.结论:USP29版萘普生钠片的溶出度方法合理,可以较好反映体内吸收情况.

关 键 词:萘普生钠片  体外溶出度  体内外相关性  萘普生钠  溶出度测定法  体内外  相关性评价  drug  evaluation  tablets  sodium  naproxen  情况  体内吸收  度方法  方程  线性回归  溶出率  吸收分数  结果  拟合  程序  血药浓度
文章编号:1006-0111(2008)03-0211-03
收稿时间:2007/7/24 0:00:00
修稿时间:2007年7月24日

Dissolution of naproxen sodium tablets and evaluation of in vitro-in vivo correlation about this drug
LE Jian,LIU Qian,SHI Jin-min and CHEN Gui-liang.Dissolution of naproxen sodium tablets and evaluation of in vitro-in vivo correlation about this drug[J].The Journal of Pharmaceutical Practice,2008,26(3):211-213.
Authors:LE Jian  LIU Qian  SHI Jin-min and CHEN Gui-liang
Institution:Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China
Abstract:Objective: To study the dissolution of naproxen sodium tablets and evaluate in vitro / in vivo correlation.Methods: Dissolution test method in naproxen sodium tablets adopted by USP was used for determination of dissolution in vitro.The concentrations of naproxen sodium tablets in human plasma were determined by HPLC.Results:The linear equation based on the dissolution rate(X) and absorption percentage(F) was F=0.330 3X+0.699 8 and the correlation coefficient was 0.991 5.Conclusion:To a certain extent,the in vitro dissolution test in USP could reflect the in vivo absorption.
Keywords:naproxen sodium tablets  dissolution  in vitro and in vivo correlation
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