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目的：建立茶碱控释、缓释制剂的体外释放度评价方法。方法：模拟胃肠道的动态ｐＨ 条件，对茶碱控释胶囊、茶碱缓释片进行了体外释放度测定。结果：药物的累积释放百分率均与中国药典１９９５ 年版二部茶碱缓释片标准相近。结论：茶碱控释胶囊、缓释片释放度均不受ｐＨ 值的影响，动态ｐＨ条件可对茶碱控释、缓释制剂的体外释放度作出正确的评价。
Objective: To establish a method for evaluating in vitro release of theophylline controlled release and sustained release preparations. Methods: The dynamic pH of gastrointestinal tract was simulated and the release of theophylline controlled release capsules and theophylline sustained release tablets was measured in vitro. Results: The cumulative release percentages of drugs were similar to those of the second edition of the Chinese Pharmacopoeia 1995 edition of theophylline sustained-release tablets. CONCLUSION: The theophylline controlled release capsules and sustained release tablets release rate are not affected by the pH value. The dynamic pH conditions can make the correct evaluation of the controlled release of theophylline and the release rate of the sustained release preparations in vitro.