萘普生钠片溶出度测定及体内外相关性评价
Dissolution of naproxen sodium tablets and evaluation of in vitro-in vivo correlation about this drug
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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。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.
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Key words:
- naproxen sodium tablets /
- dissolution /
- in vitro and in vivo correlation
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