摘要
目的采用乙基纤维素包衣来制备难溶性药物硝苯地平单室双层渗透泵控释片。方法测定不同时间药物的释放度,以累积释放量和与国外市售片比较的相似因子(f2)为评价指标,采用单因素实验筛选硝苯地平渗透泵控释片的处方。结果片芯处方和包衣增重对硝苯地平渗透泵片的体外释药行为有显著影响,含药层中PEO N80与CMS-Na为5∶2,助推层中PEO Coagulant与CMS-Na为2∶1;包衣液中PEG400用量为乙基纤维素的68%,包衣增重10%。自制控释片与市售片的释放曲线相似,且批间差异小,重复性良好。结论自制硝苯地平双层渗透泵控释片的工艺稳定,体外释药特征符合控释制剂的要求,24 h内释药完全。
OBJECTIVE To prepare the push - pull osmotic pump tablets of Nifedipine with ethyl cellulose as the coating material. METHODS The optimal formulation was selected by single - factor experiment, using similarity factor （f2） of the release curves of homemade osmotic pump tablets and foreign commercial tablets as evaluation index. RESULTS The formulation of core and coating fihn had a significant effect on the in vitro release behavior of the push - pull osmotic pump tablets of Nifedipine. The optimum formula- tion was in the drug - layer, PEO N80 ： CMS - Na （ 5 ： 2 ）, and PEO Coagulant ： CMS - Na （ 2 ： 1 ） in the push - layer. PEG 400 accounted for 68% of ethyl cellulose, coating weight increased by 10% and showed good reproducibility. The release profile of home- made controlled tablets was similar to commercially available tablets. In addition, the repeatability of three batches was good. CONCLUSION The technology of preparing the push - pull osmotic pump tablets of Nifedipine is stable. In addition, the in vitro release of homemade controlled tablet meets requirements of controlled - release preparation, and release completely within 24 h.
出处
《华西药学杂志》
CAS
CSCD
2015年第1期18-21,共4页
West China Journal of Pharmaceutical Sciences
关键词
硝苯地平
渗透泵片
单因素实验
相似因子f2
释放度
控释制剂
Nifedipine
Osmotic pump tablet
Single - factor experiment
Similarity factor f2
Release
Controlled release doseage form
