蛇床子素β-环糊精分散片处方优化及其体外释药特性  

Optimized Formulation of Osthol-beta-cyclodextrin Dispersible Tablets and Their Release in Vitro

作　　者：唐建中[1] 贝永燕[2] 王周丽[2] 陈维良[2] 朱爱军[2] 施林森[2] 张学农[2] 

机构地区：[1]苏州医药科技学校,江苏苏州215009 [2]苏州大学药学院

出　　处：《抗感染药学》2013年第3期194-199,共6页Anti-infection Pharmacy

基　　金：国家自然基金资助项目(编号:81273463);江苏省科技支撑计划(编号:BE2011670);国家大学生创新性试验计划课题资助(编号111028533;微机编号:5731503311)

摘　　要：目的:研究蛇床子素β-环糊精包合物分散片的制备工艺并考察其体外释药特性。方法:以崩解时间、硬度和片质量为指标,运用正交设计方法对处方工艺进行筛选和优化,用转篮法考察分散片的体外溶出度。结果:分散片的优化处方是12%PVPP-XL-10和6%L-HPC作为联合崩解剂,10%MCC为填充剂,2%微粉硅胶和2%硬脂酸镁为润滑剂,0.5%CMC-Na为助悬剂,所制得的分散片在30 min时,其释放量达85%。结论:该分散片符合《中国药典》2010版的规定,溶出速度明显快于物理混合物片和普通片。Objective: To develop the formulation of the dispersible tablets of osthol-β-cyclodextrin(Ost-β-CD) inclusion complexes and to study the in vitro release characteristics of them.Methods:The formulation of the dispersible tablets was screened by orthogonal design using hardness,weight,dispersible time,and dissolution of tablets as markers.Dissolution of the dispersible tablets was measured using the basket method.Results:The optimal formulation includes: 12% PVPP-XL10,6% L-HPC as combined disintegrating agents,10% MCC as filling agents,2% Tiny powder silica gel and 1% magnesium stearate as lubricants and 0.5% CMC-Na as suspending agents,The released rate parameters of the dispersible tablets were t50 =3.5 min and td=7.9 min,which were remarkly less than those of the control group.Conclusion:The dispersible tablets meet the requirement of the Chinese Pharmacopoeia(2010),which had the characteristics of rapidly and homogeneously dispersing,and quick releasing of active constituents.

关 键 词：蛇床子素 包合物 分散片 溶出度 

分 类 号：R944.9[医药卫生—药剂学]