奈福泮缓释胶囊体内外试验的相关性研究
Evaluation of the correlation between in vitro release and in vitro absorption characteristics of nefopam sustained release capsules
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摘要: 目的 评价奈福泮缓释胶囊的体外释放与体内吸收的相关性,为其质量控制提供实验依据。方法 用反相高效液相色谱法测定血浆中的奈福泮浓度,按Wagner-Nelson公式计算一定时间内奈福泮缓释胶囊的体内吸收百分率。在释放介质中进行体外释放度试验,计算相应时间内的累积释放百分率。结果 奈福泮缓释胶囊在体外缓慢释放,体内血药浓度维持时间长。结论 奈福泮缓释胶囊的体内吸收百分率与体外释放百分率间存在良好的相关关系。Abstract: OBJECTIVE To evaluate the correlativity between in vitro release and in vivo absorption of nefopam sustained release capsules.METHODS The nefopam concentration in human plasma was determined by a high performance liquid chromatography method.According to the Wagner-Nelson formula,the percentage of in vivo absorption of two nefopam sustained release capsules were calculated.In vitro release of nefopam in 3 mediums of different pH was tested and the accumulated release percentage was calculated.RESULTS The variation of pH of mediums were no significant affect on in vitro release rate of nefopam.CONCLUSION A good correlativity was showed between in vivo absorption and in vitro release of nefopam sustained release capsules.
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