甲钴胺片人体药代动力学和生物等效性
微粒子捕捉酶免法,,甲钴胺;,微粒子捕捉酶免法;,药代动力学;,生物等效性,0引言,1材料和方法,2结果,3讨论,【参考文献】
Pharmacokinetics and relative bioequivalence of mecobalamin tablets in healthy volunteersLIN Lin, WEN AiDong, ZHAO Lei, WANG Meng, WU Yin, ZHANG SanQi
Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi’an 710033, China
【Abstract】 AIM: To ensure the quality of the medicine by comparing the pharmacokinetic parameters and the relative bioavailability of Chinamade and imported mecobalamin tablets. METHODS: An open, randomized, twoperiod crossover study with a twoweek washout interval was conducted in 24 healthy volunteers. Concentrations of mecobalamin in serum were assayed by MEIA method and the main pharmacokinetics parameters (AUC, Cmax and Tmax) were analyzed by two onesided t test. RESULTS: The AUC (0-72 h), Cmax and Tmax of tramadol were (5306±1801) ng/(h·L) and (5408±1828) ng/(h·L),(286±101) ng/L and (270±98) ng/L,(3.0±0.9)h and(3.1±0.9)h, respectively. CONCLUSION: As the relative bioavailability of Chinamade and imported mecobalamin tablets are 99.2%, Chinamade and imported mecobalamin tablets are bioequivalent.
【Keywords】 mecobalamin; microparticle enzyme immunoassay MEIA; pharmacokinetics; bioequivalence ......
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