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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%
Pharmacokinetics of nicardipine hydrochloride sustained-release tablets was optimized by 23 factorial design. Eight kinds of mathematical models were used to fit the drug release behavior. The pharmacokinetics of nine volunteers were studied by HPL C method. The results showed that factors such as EC, HPC and poloxamer had significant effects on drug release, and there was no interaction between the three factors. The diffusion-dissolution model is the best model for describing drug release in nicardipine hydrochloride sustained-release tablets. Pharmacokinetic test results showed that sustained-release tablets have a significant sustained-release effect, compared with imported sustained-release capsules, the relative bioavailability was 10 9.1 ± 11.1%