中国临床药理学与治疗学2017，Vol.22Issue(9)：1012-1016,5.
匹多莫德口服液及其不同剂型的固体制剂在Beagle犬体内药代动力学比较研究
Pharmacokinetics and bioavailability of pidotimod in Beagle dog after oral solution and different solid preparations
摘要
Abstract
AIM:To investigate the bioequiavailability of the two kinds of pidotimod oral solution (Fulu-Yin and Polimod),which produced by Jiangsu Wuzhong Pharmaceutical Group Co.,Ltd and Italy Duopa pharmaceutical company,respectively,and to explore the influence of dosage forms on bioavailability of pidotimod via comparing the pharmacokinetics and relative bioavailability of pidotimod tablet,granules,capsules and dispersible tablets in beagle dogs.METHODS:Beagle dogs were orally administrated 400 mg of pidotimod oral solution Fulu-Yin and Polimod and the four kinds pidotimod solid preparations,respectively.After quantitatively measuring the concentrations of pidotimod in plasma,the pharmacokinetic parameters and relative bioavailability of Polimod,pidotimod tablet,granules,capsules and dispersible tablets were calculated and compared with those of Fulu-Yin to investigate the bioequiavailability of different dosage forms of pidotimod.RESULTS:The pharmacokinetic parameters of the pidotimod after ig administration of 400 mg of Fulu-Yin were as follows:t1/2 was (3.88 ± 0.77) h,Cmax was (23 367 ± 5 298) ng/mL,TmaxWas (1.1 ±0.5) h,AUC0-τ was (93948 ± 28 016) ng · h · mL-1.The pharmacokinetic parameters of the pidotimod after ig administration of 400 mg of Polimod were as follows:t1/2 was (3.50 ± 0.36) h,Cmax was (21233 ± 5542) ng/mL,AUC0-τ was (83 032 ±20 539) ng · h · mL-1.Besides,the pharmacokinetic parameters the pidotimod have no significant difference after ig administration of 400 mg of pidotimod tablet,granules,capsulesand dispersible tablets.CONCLUSION:The pharmaceutical Fulu-Yin and Polimod were bioequivalent in Beagle dogs,and the pidotimod oral liquid had higher bioavailability than pidotimod tablet,granules,capsules and dispersible tablets.关键词
匹多莫德/生物等效性/芙露饮/普利莫/固体制剂Key words
pidotimod/bioequivalence/Fulu-Yin/Polimod/solid preparation分类
医药卫生引用本文复制引用
沈博宇,李昊丰,殷小茜,朱璋佩,李昔诺,王广基,梁艳..匹多莫德口服液及其不同剂型的固体制剂在Beagle犬体内药代动力学比较研究[J].中国临床药理学与治疗学,2017,22(9):1012-1016,5.基金项目
国家自然科学基金面上项目(81573559 （）
81273589) （）
