琥珀酸美托洛尔缓释片的制备及释放度研究

摘要

目的：研究琥珀酸美托洛尔缓释片的制备方法与释放度。方法通过直接压片法制备琥珀酸美托洛尔缓释片，采用正交试验对其处方工艺加以优化，高效液相色谱法测定体外释放度，对处方工艺的重复性进行考察，比较其F2相似因子与市售片的差异。结果各批次取样点释放度的SD值都在2%以下，F2值分别是87.2、91.5、92.6。结论制备的琥珀酸美托洛尔缓释片和市售片具有相似的释放行为，且处方工艺稳定。%Objective To study the preparation method of Metoprolol Succinate Sustained-release Tablets and release.Methods By direct compression method by metoprolol succinate sustained-release tablets, and by orthogonal test on the prescription process to be optimized, the in vitro release degree was measured by high performance liquid chromatography(HPLC) method, the formulation and process repeatability were investigated, the F2 similar factor and a commercially available tablet differences.Results:The SD values of the release degree of each batch sample were below 2%, the F2 value was 87.2, 91.5, 92.6. Conclusion The preparation of Metoprolol Succinate Sustained-release Tablets and tablet with the release of similar behavior, and the formulation of stability.