Pharmacokinetic study of cefazedone sodium given by intravenous drip infusion in healthy volunteers
- Author:
Ping REN
1
Author Information
1. Institute of Clinical Pharmacology
- Publication Type:Journal Article
- Keywords:
Cefazedone;
LC-MS/MS;
Pharmacokinetics
- From:
Chinese Pharmaceutical Journal
2012;47(4):291-295
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To investigate the pharmacokinetics of cefazedone sodium in Chinese healthy volunteers after a single or multiple dose of intravenous drip infusion. METHODS: Thirty healthy volunteers, half male and half female, were randomly assigned to three groups of single dose and one group of multiple dose. The plasma drug concentrations after intravenous drip of single dose of 0.5, 1.0, 2.0 g and multiple dose of 1.0 g cefazedone sodium were determined by HPLC-MS/MS. RESULTS: The pharmacokinetic parameters of cefazedone sodium after single dose of 0.5, 1.0, 2.0 g were obtained as follows: t1/2z were (1.85 ± 0.53), (1.81 ± 0.29), (2.07 ± 0.32) h, respectively; AUC0-t were (145.30 ± 68.67), (244.26 ± 38.284), (513.10 ± 127.27) mg · h · L-1; AUC0-∞ were (147.89 ± 70.45), (246.60 ± 40.61), (521.02 ± 134.33) mg · h · L-1; tmax were (0.30 ± 0.06), (0.33 ± 0.00), (0.35 ± 0.05) h; ρmax were(87.18 ± 36.37), (151.13 ± 19.02), (271.94 ± 38.86) mg · L-1; Vz were (9.97 ± 2.91), (10.67 ± 1.27), (11.75 ± 1.78) L, CLz were (3.88 ± 1.239), (4.14 ± 0.57), (4.03 ± 0.86) L · h-1, respectively. The multi-dose pharmacokinetic parameters of cefazedone sodium were obtained as follows: AUCss was (208.93 ± 37.37) mg · h · L-1; AUC0-t was (208.93 ± 37.37) mg · h · L-1; AUC0-∞ was (210.64 ± 38.55) mg · h · L-1; tmax was (0.33 ± 0.00) h; ρmax was(130.20 ± 22. 83)mg · L-1; ρss was (17.41 ± 3.11) mg · L-1; ρmin was (0.89 ± 0.60) mg · L-1; DF was (7.45 ± 0.70); t1/2z was(1.77 ± 0.25) h; Vz was (12.40 ± 2.57) L; CLz was (4.90 ± 0.95) L · h-1. CONCLUSION: Cefazedone sodium displays linear pharmacokinetics in the dose range of 0.5 to 2 g after single intravenous drip injection. No significant differences between genders are observed. The differences of the main pharmacokinetic parameters of tmax, t1/2z, Vz and CLz between each group are not significant (P > 0.05). There is no significant accumulation of cefazedone sodium in healthy volunteers after multiple intravenous drip injection. Copyright 2012 by the Chinese Pharmaceutical Association.
