右兰索拉唑缓释胶囊在比格犬体内的药动学

目的：研究右兰索拉唑缓释胶囊在比格犬体内的药动学特征。方法：将6只比格犬随机分为2组，采用双周期双交叉给药方法，单次灌胃60 mg右兰索拉唑缓释胶囊受试制剂或参比制剂，LC-MS/MS法测定比格犬体内右兰索拉唑血药浓度，计算药动学参数并进行生物等效性评价。结果：单次灌胃受试制剂和参比制剂后，比格犬血浆中右兰索拉唑的t_1/2分别为（1.34±0.73）和（1.42±0.63） h，T_max分别为（5.7±0.52）和（5.8±1.17） h，C_max分别为（385.5±37.14）和（380.5±53.3） ng·mL^-1，AUC_0-t分别为（1 463.9±213.2）和（1 502.3±147.8） ng·h·mL^-1，AUC_0-∞分别为（1 476.4±215.7）和（1 514.3±149.5） ng·h·mL^-1。结论：右兰索拉唑缓释胶囊受试制剂与参比制剂在比格犬体内生物等效。

Pharmacokinetics of dexlansoprazole sustained release capsules in beagle dogs

OBJECTIVE To investigate the pharmacokinetics of dexlansoprazole sustained release capsules in beagle dogs.METHODS Six beagle dogs were randomly divided into two groups to receive test dexlansoprazole sustained release capsules or reference capsules at 60 mg, then a crossover trial was conducted one week later. Plasma samples were collected at different time points. Plasma concentrations of dexlansoprazole were determined by LC-MS/MS and the pharmacokinetic parameters were calculated.RESULTS The pharmacokinetic parameters of test and reference capsules were as follows:t_1/2 (1.34±0.73) and (1.42±0.63) h, T_max (5.7±0.52) and (5.8±1.17) h, C_max (385.5±37.14) and (380.5±53.3) ng·mL^-1, AUC_0-t (1 463.9±213.2) and (1 502.3±147.8) ng·h·mL^-1, AUC_0-∞ (1 476.4±215.7) and (1 514.3±149.5) ng·h·mL^-1.CONCLUSION The dexlansoprazole sustained release capsules are bioequivalent to the reference capsules.