马来酸曲美布汀缓释片研制

目的：研制一种马来酸曲美布汀缓释片，并对比自研马来酸曲美布汀缓释片与原研药的体外释放情况。方法测定自研药与原研药在pH 1．2、pH 4．0、pH 5．2、pH 6．8及水5种介质中的释放度，采用相似性f2因子法评价不同pH介质条件下两种制剂释放曲线的相似性。结果两制剂在pH 1．2、pH 4．0、pH 5．2、pH 6．8及水介质中的f2因子分别为88．3，60．2，84．9，65．7，70．0，均大于50。结论自研药与原研药体外释放行为一致。

Preparation of Trimebutine MaIeate Extended-reIease TabIets

OBJECTIVE To prepare a Trimebutine Maleate Extended-release tablet,and compare the in vitro Release Behavior of Self-prepared Trimebutine Maleate Extended-release Tablet and Original Prepara-tion.METHODS The release behavior of the self-prepared preparation and original preparation were inspected in pH 1.2,pH 4.0,pH 5.2,pH 6.8 buffer solution and water;the f2 factor method was used to evaluate the consistency of the in vitro release behavior between the two preparations .RESULTS The f2 factors of the two preparations in pH 1.2,pH 4.0,pH 5.2,pH 6.8 and water buffer solution were 88.3,60.2,84.9,65.7,70.0,respectively.All of the f2factor values were greater than 50.CONCLUSION The self-prepared preparation shows consistent in vitro release behavior with that of the original preparation .