摘要
利用 2 3 析因设计对盐酸尼卡地平缓释片处方进行优化 ,利用 8种数学模型对其药物释放行为进行了拟合并利用 HPL C法对 9名志愿者人体药动学进行了研究。结果表明 ,EC、HPC和泊洛沙姆等因素对药物释放有显著影响 ,这 3种因素间不存在相互作用。扩散 -溶蚀模型是描述盐酸尼卡地平缓释片中药物释放的最佳模型。药动学试验结果表明 ,缓释片缓释作用显著 ,与进口缓释胶囊相比 ,其相对生物利用度为 10 9.1± 11.1%
A 2 3 factorial design was adopted to optimize the formulation of nicardipine sustained release (SR) tablets. Factors such as EC, HPC and poloxamer were found to have significant effects on drug release from the SR tablets and no interactions were observed between these three factors. Eight mathematical models were applied to simulate the drug release profiles, and diffusion erosion model was found to be the most suitable one. The human pharmacokinetics was investiga ted in nine male healthy volunteers. The relative bioavailability of nicardipine SR tablets was 109.1 ±11.1% as compared with Perdipine LA 40 capsules.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2000年第6期260-262,共3页
Chinese Journal of Pharmaceuticals
关键词
盐酸尼卡地平
缓释片
放机理
人体药动学
nicardipine hydrochloride
sustained release tablets
formulation optimization
release mechanism
human pharmacokinetics
