Study on pharmacokinetics of cefotetan disodium in Chinese healthy volunteers
- VernacularTitle:头孢替坦二钠在中国健康人体的药代动力学研究
- Author:
Su-Xia XIA
1
;
Si TANG
;
Shi-Liang ZHANG
;
Xiao-Qian DONG
;
Rui YANG
;
Yue-Min WANG
Author Information
1. 辽宁省中医药研究院临床药理室
- Keywords:
cefotetan;
pharmacokinetic;
LC-MS/MS
- From:
The Chinese Journal of Clinical Pharmacology
2014;(4):320-323
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the pharmacokinetics of cefotetan diso-dium injection in Chinese healthy volunteers.Methods The study was designed as an open , randomized , parallel and single-dose single cycle study.Thirty healthy volunteers were divided into three groups.Each group included five volunteers male and five female volunteers.The vol-unteers in different groups were administered with single dose of 0.5 , 1.0 or 2.0 g cefotetan disodium , respectively.Plasma concentrations of cefotetan disodium were determined by LC -MS/MS method.The phar-macokinetic parameters of cefotetan disodium were calculated by DAS version 2.1 software.Results The main pharmacokinetic parameters of three doses (0.5, 1.0, 2.0 g)of cefotetan disodium were as follows:cmax were(65.25 ±19.84), (118.06 ±20.54), (231.24 ±66.75)mg· L-1;tmax were(0.99 ±0.09), (0.98 ±0.08), (0.97 ±0.12)h; t1/2 were(4.44 ±0.72 ), (3.93 ±0.46 ), (4.18 ±0.73 ) h; AUC0-t were ( 263.58 ± 63.81 ) , ( 421.93 ± 48.87 ) , ( 896.99 ± 249.78 ) mg· L-1 · h -1 , respectively.Urinary recovery rate within 24 h was (65.62 ±10.23 )%.Conclusion The plasma concentration - time curve fits two compartment model.The safe dose was 0.5-2.0 g.
