Bioequivalence of Metoprolol Tartrate Tablets in healthy volunteers
- VernacularTitle:酒石酸美托洛尔片人体生物利用度和生物等效性研究
- Author:
Jing WANG
;
Liangqing FU
;
Yongbiao GUAN
;
Yi FANG
;
Zeyuan LIU
- Publication Type:Journal Article
- Keywords:
Metoprolol Tartrate Tablets;
HPLC-fluorescence detection;
bioequivalence
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2004;0(09):-
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To study the bioequivalence of domestic and imported Metoprolol Tartrate Tablets in Chinese healthy volunteers.METHODS: According to the rule published by SFDA,the serum concentration of 20 selected volunteers among 18 to 40 years old was determined by HPLC-fluorescence detection after giving domestic and imported Metoprolol Tartrate Tablets 0.1g,and the pharmacokinetic parameters were calculated by DAS software.RESULTS: The method of HPLC-fluorescence detection to study the pharmakokinetics of Metoprolol Tartrate was sensitive,reliable,accurate and reasonable.The main pharmakokinetics parameters of domestic and imported Metoprolol Tartrate Tablets were T_(max):(1.11)?(0.36 h) and(1.39)?(0.65 h) respectively;C_(max):(269.20)?(87.15)(?g?L~(-1)) and(262.03)?(75.52)(?g?L~(-1)) respectively;AUC_(0-12h):(1088.91)?(510.52)(?g?L~(-1)?h) and(1098.29)?5(55.14)(?g?L~(-1)?h) respectively.The relative bioavailability of domestic Metoprolol Tartrate Tablets was(100.09)%.CONCLUSION: The domestic and imported Metoprolol Tartrate Tablets was bioequivalents.
