依折麦布包合物口腔崩解片的制备及体外溶出

Preparation and In Vitro dissolving Study of Orally Disintegrating Tablets of Ezetimibe Inclusion Complexes

目的:制备依折麦布包合物口腔崩解片,对其质量进行评价。方法:依折麦布与HP-β-CD用旋转蒸发法制成包合物,正交法选择崩解剂后制成口腔崩解片,考察包合物崩解片的体外溶出度。结果:依折麦布包合物包封率和载药量分别为71.12%、18.52%,以MCC、PVPP、L-HPC为崩解剂制成的崩解片累积溶出度101.49%。结论:选定的方法和辅料可用于制备依折麦布HP-β-CD包合物口腔崩解片,体外溶出符合要求。

Objective:To prepare the orally disintegrating tablets of ezetimibe inclusion complex and quality evaluation of it.Methods:The ezetimibe was prepared HP-β-CD inclusion complex with rotary evatoration,the disintegrating agent was determined by orthogonal design method,In Vitro dissolving were examined of orally disintegrating tablets of ezetimibe inclusion complexes.Results:The encapsulation efficiency and drug loading capacity of ezetimibe inclusion complex was 71.12%、18.52%,the cumulative dissolution with MCC、PVPP、L-HPC as material preparation of orally disintegrating tablets is 101.49%.Conclusion:The selected accessory can be used for the preparation of orally disintegrating of ezetimibe inclusion complex and up to the standard of In Vitro dissolving.