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目的比较两种注射用盐酸尼非卡兰在Beagle犬体内的药动学特征。方法采用随机、交叉、自身对照的试验设计,将18只Beagle犬分别先后单次静脉注射两种盐酸尼非卡兰3.125 mg·kg~(-1),用HPLC法测定其血药浓度,用Win Non Lin 6.3软件计算药动学参数并进行比较。结果分别先后单次静脉注射相同剂量的盐酸尼非卡兰供试和参比制剂3.125 mg·kg~(-1)后,犬血浆中尼非卡兰的AUC_(0→t)分别为118.01±15.74、116.39±47.66μg·m L~(-1)·min,AUC_(0→∞)分别为119.84±15.40、118.50±46.80μg·m L~(-1)·min,C_(max)分别为5.31±2.28、4.45±2.27μg·m L~(-1),T_(max)分别为1.67±1.63、1.00 min,t1/2分别为34.90±4.53、34.76±9.77 min。结论两种注射用盐酸尼非卡兰在Beagle犬体内的药动学过程无显著差异。
Objective To compare the pharmacokinetics of two kinds of nifedipine hydrochloride for injection in Beagle dogs. Methods A randomized, crossover and self-controlled trial design was used. 18 Beagle dogs were treated with intravenous injection of two nifedipine hydrochloride (3.125 mg · kg -1) by single intravenous injection respectively. The plasma concentrations of Win Non Lin 6.3 software calculates and compares pharmacokinetic parameters. Results The AUC_ (0 → t) of nifeducan in the plasma of dogs were respectively 118.01 ± (-1) after a single intravenous injection of the same dose of nifeducin hydrochloride test and reference formulation of 3.125 mg · kg -1 15.74,116.39 ± 47.66μg · m L -1 min and AUC 0-0∞ were 119.84 ± 15.40 and 118.50 ± 46.80μg · m L -1 · min respectively, C max were 5.31 ± 2.28,4.45 ± 2.27μg · m L -1, T max was 1.67 ± 1.63 and 1.00 min, respectively, t1 / 2 was 34.90 ± 4.53 and 34.76 ± 9.77 min, respectively. Conclusion There was no significant difference in the pharmacokinetics of nifedipine hydrochloride for injection in Beagle dogs.