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目的:研制马来酸曲美布汀胃漂浮缓释片并测定其体外释放度及漂浮性能。方法:以羟丙基甲基纤维素(HPMC)K15M、山榆酸甘油酯为主要辅料直接压片制备马来酸曲美布汀胃漂浮缓释片。应用转篮法和改良法分别测定并比较其体外释放度及漂浮性能。结果:改良法蠕动泵的流速为2.2mL·min-1,转速为50r.min-1时,测定本品的释药曲线与转篮法较相似。2种方法测定本品的起漂时间在5s内,持续漂浮时间均大于12h。结论:改良法与转篮法均可用于本品体外释放度及漂浮性能的测定,但改良法更能模拟体内条件且对漂浮时间的观察无影响。
Objective: To develop trimebutine maleate floating sustained-release tablets and determine its in vitro release and floating performance. Methods: Trimebutine maleate sustained-release tablets were prepared by direct compression with HPMC K15M and glycerol behenate as the main excipients. The basket release method and the modified method were used to determine and compare the in vitro release and the floating performance. Results: The modified method of peristaltic pump flow rate of 2.2mL · min-1, the speed of 50r.min-1, measured the release curve of this product is similar to the basket method. 2 methods to determine the starting time of this product within 5s, sustained floating time are greater than 12h. Conclusion: Both the modified method and the spin-off method can be used to determine the in vitro release and floating performance. However, the modified method can better simulate the in vivo conditions and has no effect on the observation of floating time.