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目的:研究N-三甲基壳聚糖(TMC60)对硝苯地平片药物动力学的影响。方法:以Beagle犬为实验动物,分别口服硝苯地平片Ⅰ(含TMC60)及硝苯地平片Ⅱ(不含TMC60),采用单剂量交叉实验,在预定的时间点取血样,测定硝苯地平的浓度,并用3P97软件包拟合两种片剂的药代动力学参数。结果:硝苯地平片Ⅰ、Ⅱ在犬体内均符合口服吸收二室模型。两种片剂的主要参数T_(max)、C_(max)、Ka、AUC等均有显著性差异(P<0.05)。结论:TMC60可显著改善硝苯地平在犬体内的吸收,提高其生物利用度,是一种较好的促进吸收的辅料。
Objective: To study the effect of N-trimethyl chitosan (TMC60) on the pharmacokinetics of nifedipine tablets. Methods: The Beagle dogs were used as experimental animals. Oral nifedipine tablets Ⅰ (including TMC60) and nifedipine tablets Ⅱ (excluding TMC60) were orally administered. Single-dose crossover test was used to take blood samples at predetermined time points. Nifedipine The pharmacokinetic parameters of the two tablets were fitted using the 3P97 software package. Results: Nifedipine tablets Ⅰ and Ⅱ all fit the two-compartment model of oral absorption in dogs. The main parameters T_ (max), C_ (max), Ka, AUC of the two tablets were significantly different (P <0.05). Conclusion: TMC60 can significantly improve the absorption of nifedipine in dogs and improve its bioavailability, which is a good adjuvant to promote absorption.