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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系
Objective: To evaluate the correlation between in vitro release of theophylline sustained-release tablets and absorption in vivo, and to provide an experimental basis for its quality control. Methods: The theophylline concentration in plasma was determined by RP-HPLC, and the in vivo absorption rate of two kinds of theophylline sustained-release tablets was calculated according to Wagner-Nelson formula. In vitro release tests were carried out in 3 different pH media to calculate the cumulative release percentage over the corresponding time. Results: The pH of the medium had no significant effect on the in vitro release of theophylline sustained-release tablets. CONCLUSIONS: There is a good correlation between the in vivo absorption of theophylline sustained-release tablets and the percentage of in vitro release