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目的:研究丙硫氧嘧啶缓释片在beagle犬体内的药动学过程,测定其药动学参数、相对于普通片的生物利用度和生物等效性。方法:采用双交叉试验设计法,取6条健康beagle犬随机分成2组,分别服用丙硫氧嘧啶缓释片和普通片,用高效液相色谱法测定丙硫氧嘧啶的血药浓度,利用3P97软件包计算主要的药动学参数以及相对生物利用度,并判断生物等效性。结果:犬口服丙硫氧嘧啶后符合二房室模型特征,缓释片和普通片的MRT分别为(5.3±s0.6)h和(3.0±0.6)h,tmax分别为(2.4±0.5)h和(1.1±0.3)h,cmax分别为(15.6±2.0)和(23.3±2.9)mg·L-1,缓释片的相对生物利用度为(114±4)%。结论:丙硫氧嘧啶缓释片和普通片具有生物等效,且缓释片具有12h缓释效果。
Objective: To study the pharmacokinetics of propylthiouracil sustained-release tablets in beagle dogs and determine its pharmacokinetic parameters, bioavailability and bioequivalence relative to common tablets. Methods: Double crossover design was adopted. Six healthy beagle dogs were randomly divided into two groups, each of which was treated with propylthiouracil sustained-release tablets and ordinary tablets. The plasma concentration of propylthiouracil was determined by HPLC. 3P97 software package to calculate the main pharmacokinetic parameters and relative bioavailability, and to determine the bioequivalence. Results: The oral administration of propylthiouracil was consistent with the characteristics of two-compartment model. The MRT of sustained release tablets and ordinary tablets were (5.3 ± s0.6) h and (3.0 ± 0.6) h, respectively, and the tmax were (2.4 ± 0.5) h And (1.1 ± 0.3) h, cmax were (15.6 ± 2.0) and (23.3 ± 2.9) mg · L-1, respectively. The relative bioavailability of sustained release tablets was (114 ± 4)%. Conclusion: Propylthiouracil sustained-release tablets and ordinary tablets are bioequivalent, and sustained-release tablets have a 12h sustained-release effect.