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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 study the preparation process of Osthole β-cyclodextrin inclusion complex dispersible tablets and study its in vitro release characteristics. Methods: According to the disintegration time, hardness and the quality of the tablets, orthogonal design was used to screen and optimize the prescription process. The dissolution rate of dispersible tablets was investigated by spin basket method. RESULTS: The optimal formulation of dispersible tablets was 12% PVPP-XL-10 and 6% L-HPC as the joint disintegrator, 10% MCC as filler, 2% silica fume and 2% magnesium stearate as lubricant, % CMC-Na as a suspending agent, the release sheet prepared at 30 min, the release of 85%. Conclusion: The dispersible tablets meet the “Chinese Pharmacopoeia” 2010 version of the provisions of dissolution rate was significantly faster than the physical mixture tablets and ordinary tablets.