萘普生钠片溶出度测定及体内外相关性评价
投稿时间:2007-07-24    点此下载全文
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,(3):211~213
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作者单位
乐健 上海市食品药品检验所,上海201203 
刘茜 上海市食品药品检验所,上海201203 
石劲敏 上海市食品药品检验所,上海201203 
陈桂良 上海市食品药品检验所,上海201203 
中文摘要: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。
中文关键词:萘普生钠片  体外溶出度  体内外相关性
 
Dissolution of naproxen sodium tablets and evaluation of in vitro-in vivo correlation about this drug
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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