丹皮酚-SPE_7-β-CD包合物片剂的处方研究  

Optimization of the Formulation of Paeonol-SPE_7-β-CD Inclusion Complex Tablets

作　　者：邓步华[1] 张荣发[1] 杨宗发[1] 

机构地区：[1]重庆医药高等专科学校,重庆市400030

出　　处：《中国药房》2009年第28期2211-2212,共2页China Pharmacy

摘　　要：目的:优化丹皮酚-SPE7-β-环糊精(CD)包合物片剂的处方。方法:以溶出度为指标,黏合剂10%淀粉浆、崩解剂干淀粉和润滑剂硬脂酸镁的用量为主要考察因素,采用正交试验筛选最佳处方,并进行验证试验。结果:最佳处方为丹皮酚-SPE7-β-CD106.2g、乳糖48.7g、10%淀粉浆3.0g、干淀粉6.0g、硬脂酸镁0.1g,所制3批样品溶出度均值为95.56%。结论:该优化处方较为理想,可行性较强。OBJECTIVE ： To optimize the formulation of paeonol -SPE7-β-CD inclusion complex tablets. METHODS ： The formulation was optimized by orthogonal test with dissolution rate serves as index and the amount of adhesive （10% starch paste）, disintegrant （dry starch） and lubricant （magnesium stearate） served as major factors, meanwhile a verification test was conducted. RESULTS： The optimum formulation of paeonol -SPE7-β-CD inclusion complex tablets was as follows： paeonol-SPE7-β-CD 106.2 g, lactose 48.7 g, 10% starch paste 3.0 g, dry starch 6,0 g, and magnesium stearate 0. lg. The mean dissolution rate was 95.56% for three batches of samples prepared under the above condition. CONCLUSION： The op- timized formulation is ideal and feasible.

关 键 词：丹皮酚-SPE7-β-CD包合物片剂 处方设计 正交试验 溶出度 

分 类 号：R943[医药卫生—药剂学]