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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。
Objective To investigate the feasibility of preparing pulsed drug delivery system by taking piperazine ferulate as a model drug. Methods A tablet core containing piperazine ferulate was prepared, and the outer layer was coated with ethylcellulose material to prepare pulsatile release tablets. Through in vitro release test, examine the core and the coating prescription on drug release delay. Results The type and amount of disintegrant, the thickness of coating layer and the amount of porogen in coating layer all influenced the release behavior of piperazine ferulic acid pulse tablets. Conclusion The in vitro release of ferulic acid piperazine pulsatile release tablets showed good pulse release behavior and its release rate could be adjusted by adjusting the amount of disintegrant, the thickness of the coating and the amount of porogen in the coating Time lag.