复方单硝酸异山梨酯缓释胶囊的制备及释放度测定

制备复方单硝酸异山梨酯缓释胶囊，并考察其释放度。方法：采用流化床包衣技术制备微丸，通过单因素试验法对复方缓释胶囊中单硝酸异山梨酯缓释微丸影响较大的因素进行优选，并采用高效液相色谱法对其释放度进行测定；通过对阿司匹林包衣液处方的考察筛选最优处方。结果：由最佳处方制备的复方单硝酸异山梨酯缓释胶囊，单硝酸异山梨酯和阿司匹林均能达到良好的释放效果，其中单硝酸异山梨酯体外释放行为符合Higuchi方程，并且与进口制剂释放行为相似；阿司匹林在酸性和碱性介质中释放度均符合要求。结论：本品处方合理，制备工艺稳定，缓释效果良好。

Preparation and Release Determination of Compound Isosorbide Mononitrate Sustained release Capsules

To prepare compound isosorbide mononitrate sustained-release capsules and study the drug release. Meth- otis： lsosorbide mononitrate pellets were prepared by the fluidized bed coating technology. The influencing factors in the preparation process were examined and the major factors were optimized by single factor experiments. The drug release was determined by HPLC. The best formula was screened by optimizing aspirin coating solution. Results： The compound isosorbide mononitrate sustained-release capsules wereprepared by the best formula. Both the two drugs could achieve promising release, and in vitro release behavior of isosor- bide mononitrate was fitted Higuchi equation, which was similar to that of the imported preparations. The release of aspirin in acidic and alkaline media was in coincidence with the release requirements. Conclusion： The formula is reasonable and the preparation process is stable with promising sustained release property.