目的制备葛根素双层渗透泵控释片,考察影响其释药行为的因素。方法调整促渗剂的含量及包衣液的成分,研究单一因素对渗透泵体外释放的影响,并通过均匀设计实验,确定最优处方。结果葛根素双层渗透泵控释片的释药行为受促渗剂、衣膜厚度、致孔剂的影响显著。结论采用最优处方成功制备葛根素双层渗透泵控释片,释放行为符合零级释放特征。
OBJECTIVE To prepare two - layer controlled osmotic - pump tablets of puerarin and investigate the drug release in vitro. METHODS The single factor that aft)cted drug release in vitro were investigeted. Then, uniform design was used to optimize the formulation of controlled osmotic - pump tablets. RESULTS Drug release profiles in vitro were obviously affected by membrane thickness, penetrating agents and porogen. CONCLUSION Two - layer controlled osmotic - pump tablets of puerarin were prepared according to the optimal formulation with zero-order kinetics.