复方呋塞米螺内酯胶囊的处方筛选  

Optimizing prescription of the compound furosemide and spironolactone capsules

作　　者：李美珍[1] 上官可可 杨金荣[2] 房志仲[2] 

机构地区：[1]天津医科大学第二医院药剂科,天津300211 [2]天津医科大学药学院药剂学教研室,天津市临床药物关键技术重点实验室,天津300070

出　　处：《天津医科大学学报》2016年第2期171-175,共5页Journal of Tianjin Medical University

摘　　要：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f_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≤f_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。Objective： To Use uniform design method and correlation analysis to optimize the prescription of compound capsules.Methods： Many different formulations were designed by the uniform experimental of statistics, the blank capsules of all formulations were made, and the disintegration time, the packing amount divergent, and dissolution experiments of capsule as inspection indexes were added to set up the best formulations. Determination of the dissolution of self-made and marketed preparations in different dissolution media, and calculation of the f_2 factor were carried out. Results： The kind and dosage of accessories in the best formulations were determined, CMSNa was disintegrant, water was binding agent, MCC and lactose were used as fillers, and magnesium stearate and French chalk were used as lubricants. There was no significant difference in the dissolution behaviors of the self-made and marketed preparations in different dissolution media. Conclusion： The selected optimal preparation and the formulation of compound capsules have good process conditions,and the uniform particles, hardness is appropriate, the capsule appearance neat, sputtering quickly.

关 键 词：复方胶囊 呋塞米 螺内酯 处方筛选 f_2因子 

分 类 号：R9[医药卫生—药学]