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.
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)
关键词
蛇床子素
包合物
分散片
溶出度
osthol
inclusion complexes
dispersible tablets
dissolution rate
