(1.Department of Pharmacy,The Second Hospital, Tianjin Medical University,Tianjin 300211,China;2.Department of Pharmacy, College of Pharmacy, Tianjin Medical University, Tianjin Key Laboratory on Technologies Enabling Development of Clinical Therapeutics and Diagnostics (Theranostics),Tianjin 300070,China)
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复方胶囊' target="_blank" rel="external">">复方胶囊
; 呋塞米; 螺内酯; 处方筛选; ?2因子' target="_blank" rel="external">">
目的:利用均匀设计法及相关分析优选复方呋塞米螺内酯胶囊处方。方法:以不同处方配比的崩解剂、粘合剂、填充剂、润滑剂为载药辅料,以崩解时限、装量差异、体外溶出度等作为考察指标,采用均匀设计法及相关分析筛选最优处方。测定自制与市售制剂在不同溶出介质中的体外溶出度,并计算?2因子进行比较。结果:确定最佳处方中辅料的种类及其用量,羧甲基淀粉钠(CMS-Na)为崩解剂,水为粘合剂,微晶纤维素(MCC)、乳糖为填充剂,硬脂酸镁、滑石粉为润滑剂。自制与市售制剂在不同溶出介质中溶出度行为并无显著差异(50≤?2≤100)。结论:该试验筛选出的优化复方制备处方和工艺条件,所得颗粒均匀、硬度适宜,制得胶囊外观整洁、崩解迅速。
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