采用研磨法混合主辅料,经湿法制粒压片,自制格列美脲片(GMT)和羟丙基-β-环糊精格列美脲片(HP-β-CDGMT)并对其进行质量评价.制备的片剂中崩解剂为质量分数5％低取代羟丙基纤维素,稀释剂为预胶化淀粉与微晶纤维(质量比5∶1),黏合剂为质量分数10％淀粉浆.2种自制片的片重差异、脆碎度、含量和含量均匀度,均符合2010版中国药典规定.HP-β-CDGMT溶出与GMT相比,明显得到改善.添加HP--CD辅料的优化片剂处方,工艺简单易行且自制HP-β-CDGMT主药溶出符合美国药典(USP 35)要求.
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