阿魏酸哌嗪脉冲释药片的制备及其体外释药影响因素考察

Preparation and in Vitro Study of Piperazine Ferulate Pulsatile-release Tablets

摘要: 目的以阿魏酸哌嗪为模型药物，考察制备脉冲给药系统的可行性。方法制备含有阿魏酸哌嗪的片芯，在外层进行乙基纤维素材料的包衣，制备脉冲释药片。通过体外释放度实验，考察片芯及包衣层处方对药物释放时滞的影响。结果片芯中崩解剂种类及用量、包衣层厚度、包衣层中致孔剂用量均对阿魏酸哌嗪脉冲释药片的释药行为有所影响。结论阿魏酸哌嗪脉冲释药片体外释放度试验中呈现良好的脉冲释药行为，并可通过调整崩解剂用量、包衣层厚度、包衣层中致孔剂用量等因素调整其释药时滞。

Abstract: OBJECTIVE To investigate the preparation of pulsatile-release tablet of piperazine ferulate. METHODS The core tablet containing piperazine ferulate was first prepared and then coated with ethycellulose. Effect of core and coating layer was evaluated by dissolution test in vitro. RESULTS The kind of disintegrants, amount of disintegrant, amount of PEG6000, and coating weight of ethycellulose layer were demonstrated to influence the drug release of piperazine ferulate pulsatile-release tablet. CONCLUSION The pulsatile-release tablet of piperazine ferulate has been designed to release drug rapidly at the predetermined time. The release profile can be adjusted by the amount of disintegrant, amount of PEG6000 and the coating weight of ethycellulose layer.