The bioequivalence of 3 kinds of cefdinir preparations in healthy volunteers
10.13699/j.cnki.1001-6821.2015.15.015
- VernacularTitle:3种头孢地尼在健康人体内的生物等效性研究
- Author:
Yi-Meng WANG
1
;
Ning-Min ZHAO
;
Hong-Fei DUAN
;
Hong-Wei ZHAO
;
Wei ZHANG
;
Yu-Hua QIN
Author Information
1. 郑州大学 人民医院 药学部
- Keywords:
cefdinir;
UPLC-MS/MS;
blood drug concentration;
pharmacokinetic;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2015;(15):1516-1518,1535
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a high performance liquid chroma-tography-tandem mass spectrometry ( UPLC-MS/MS) method to deter-mination the plasma concentration of cefdinir and to study the pharmaco-kinctics and bioequivalence of three kinds of cefdinir formulations in healthy volunteers.Methods In a randomized, 3 way-crossover and self-control study, 24 healthy male volunteers were orally administrated with three kinds of cefdinir formulations ( test sample and reference sam-ple) 100 mg.The concentrations of cefdinir in plasma were determined by LC-MS/MS.The main pharmacokinetic parameters were calculated.Results The method was validated by investigating the accuracy and precision for intra and inter -day runs in a linear concentration from 11.50-2300.00 ng· mL-1.The main pharmacokinetic parameters of test (cefdinir tables A drug, cefdinir dispersible tables B drug ) and reference (cefdinir capsules, C drug ) formulations in plasma were shown as follows:tmax were (3.00 ±0.80),(3.20 ±0.90) and (3.50 ±0.70) h ; Cmax were (548.96 ±184.58 ), ( 607.09 ±236.38 ) and ( 570.18 ±172.37 ) ng· mL-1;t1/2 were ( 2.00 ±0.30),(1.90 ±0.40)and (1.90 ±0.30) h; AUC0-t were ( 2755.35 ±956.10 ) , ( 3037.49 ±1014.42 ) and (2756.43 ±804.06 ) ng · mL-1 · h, respectively.The relative bioavailability F were ( 104.20 ±37.50 )% and (111.50 ±29.70)%.Conclusion The method was proved to be accurate, rapid and sensitive.The three kinds of cefdinir formulations are bioequivalent in healthy volunteers.
