茶碱缓释片体内外试验的相关性

目的：评价茶碱缓释片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茶碱浓度，按Ｗａｇｎｅｒ－Ｎｅｌｓｏｎ公式计算一定时间内２种茶碱缓释片的体内吸收百分率。在３种不同ｐＨ的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：介质的ｐＨ变化对茶碱缓释片的体外释放度无明显影响。结论；茶碱缓释片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

Evaluation of the correlation between in vitro release and in vivo absorption characteristics of theophylline sustained release tablets

OBJECTIVE:To evaluate the correlativity between in vitro release and in vivo absorption of theophylline sustained release tablets.METHOD:The theophylline concentration in human plasma was determined by a high performance liquid chromatography method.According to the Wagner-Nelson formula,the percentages of in vivo absorption of two theophylline sustained release tablets were calculated.In vitro release of theophylline 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 theophylline.CONCLUSION:A good correlativity was showed between in vivo absorption and in vitro release of theophylline sustained release tablets.