摘要
目的研制凝胶骨架型尼群地平缓释片,考察处方、工艺等因素对体外释药行为的影响。方法以HPMC为凝胶骨架材料制备缓释片,对释放介质pH值,药物粒径、骨架材料和致孔剂用量,压片压力等对体外释药行为的影响进行了考察。结果药物从骨架片中的释放符合Highchi动力学过程,释药速率受原料药粒径和骨架材料用量的影响,释放介质pH值、致孔剂用量和压片压力对释药速率影响较小。结论本文研制的尼群地平缓释片处方合理,有较好的可控性,调整处方,控制药物粒径,可得到符合设计要求的释药速率。
AIM:Nitrendipine sustained-release tablets were developed as a gel matrix for using once daily and the effect of formulation and process on its in vitro release characteristics was evaluated.METHOD:Nitrendipine sustained-release tablets were prepared using hydroxypropylmethyl cellulose(HPMC)as the gel matrix material.The effects of pH of the release medium,particle size,the amount of HPMC,Ethyl cellulose and Lactose and the hardness of the tablets on the release profile of nitrendipine were investigated.RESULT:The release profile of nitrendipine was properly described by Higuchi equation.The release rate was controlled or modified by nitrendipine particle size and the amount of matrix material,while slightly affected by pH value of the release medium,amount of lactose and hardness of the tablets.CONSLUSION:The selected formulation of nitrendipine sustained-release tablets is controllable.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2004年第6期503-507,共5页
Journal of China Pharmaceutical University
关键词
尼群地平
缓释片
释药速率
HPMC
Nitrendipine
Sustained-release tablets
Release rate
HPMC
