克拉霉素掩味颗粒的制备及评价

Preparation and Evaluation of Clarithromycin Taste Masked Granules

制备克拉霉素掩味颗粒并对其进行评价。通过流化床包衣和造粒工艺制备克拉霉素掩味颗粒。对样品在不同pH溶出介质的溶出度进行分析,通过傅里叶红外光谱、热分析、扫描电镜及X-射线粉末衍射对样品和物理混合物(克拉霉素+卡波姆+邻苯二甲酸羟丙甲基纤维素酯)进行分析,比较两者差异,通过志愿者对掩味效果进行评价。通过该工艺制备的克拉霉素颗粒体外释放度良好,掩味效果优异。制备的克拉霉素掩味颗粒的耐酸性较好,与美国市售制剂相比溶出度相似性较高,并且该工艺能应用于工业化生产。

Clarithromycin taste masked granules were prepared and evaluated.Clarithromycin taste masked granules were prepared by combination of fluid-bed coating procedure with palletization.The final products were evaluated by dissolution in different solution,FT-IR(KBr),DSC,SEM,X-Ray diffraction,and taste evaluation.The Clarithromycin granules prepared by this process has good dissolution and excellent masking effect.Clarithromycin masked granules have good resistance and high similarity for the in vitro dissolution compared with the commercial preparations in United States,and the process can be applied to industrial production.