Zhong Meng,Sun Quan,Feng Yue,Wan Shengli,Zhang Jingqing.Bioequivalence of positive ion azithromycin niosomes in different particle sizes[J].J Amry Med Univ (J Third Mil Med Univ),2014,36(12):1295-1298.
Zhong Meng,Sun Quan,Feng Yue,Wan Shengli,Zhang Jingqing.Bioequivalence of positive ion azithromycin niosomes in different particle sizes[J].J Amry Med Univ (J Third Mil Med Univ),2014,36(12):1295-1298.DOI:
Bioequivalence of positive ion azithromycin niosomes in different particle sizes
Objective To compare the pharmacokinetic parameters and bioavailability of positive ion azithromycin niosomes and azithromycin solution in rats. Methods Drug concentrations in the plasma at different time points were determined by HPLC after single oral dose of small-particle-size azithromycin niosome (AMNSS)
large-particle-size azithromycin niosome (AMNSL) and azithromycin sol
ution (AM) in rats. The pharmacokinetic parameters were calculated by DAS 2.1.1. Statistical moment parameters were adopted to calculate the pharmacokinetic parameters including C
max
AUC
0-t
and t
max
. Analysis of nonparametric tests and two one-sided t-tests were used to evaluate the bioequivalence of the 3 formulations. Results The pharmacokinetic parameters of AMNSS
AMNSL and AM in plasma were: C
max
18.73
9.2 and 10.31 mg/L
respectively; t
max
6
4 and 2 h
respectively; AUC
0-t
371.79
160.41 and 136.09 mg·h/L
respectively; and AUC
0-∞
454.92
263.16 and 158.50 mg·h/L
respectively. AMNSS and AMNSL relative bioavailability F
0-t
was 273.19% and 117.87%
respectively. The main pharmacokinetic parameters analyzed by variance
two side t-test and Wilcoxon rank sum test showed significant differences between AMNSS and AM
as well as AMNSS and AMNSL in vivo (
P
0.05)
but no significant difference between AMNSL and AM (