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目的研究盐酸莫西沙星片在健康志愿者体内两种条件下的药动学。方法采用随机交叉自身对照试验设计,24名健康男性志愿者随机交叉单剂量空腹(或餐后)口服400 mg盐酸莫西沙星片。采用HPLC-UV法测定受试者血浆中莫西沙星的浓度,计算药动学参数,评价制剂在两种条件下的药动学行为。结果空腹条件下,盐酸莫西沙星片的主要药动学参数为:Tmax=1.55±0.96 h,Cmax=3.45±0.88μg·m L-1,AUC0-t=58.77±13.02μg·m L-1·h,AUC0-∞=60.50±13.71μg·m L-1·h;餐后条件下,盐酸莫西沙星片的主要药动学参数为:Tmax=2.66±1.48 h,Cmax=3.16±0.70μg·m L-1,AUC0-t=57.01±9.95μg·m L-1·h,AUC0-∞=59.00±10.60μg·m L-1·h。结论餐后与空腹条件相比,除了Tmax有所延迟外,其余药动学参数均无太大差别,表明食物可能会减缓盐酸莫西沙星的吸收。
Objective To study the pharmacokinetics of moxifloxacin hydrochloride tablets in two conditions in healthy volunteers. Methods A randomized crossover self-controlled trial was designed. Twenty-four healthy male volunteers were randomized to receive a single dose of 400 mg moxifloxacin hydrochloride fasting (or postprandial). The concentrations of moxifloxacin in the plasma of the subjects were determined by HPLC-UV method. The pharmacokinetic parameters were calculated and the pharmacokinetics of the preparations were evaluated under the two conditions. Results Under the fasting condition, the main pharmacokinetic parameters of moxifloxacin hydrochloride tablets were as follows: Tmax = 1.55 ± 0.96 h, Cmax = 3.45 ± 0.88μg · m L-1, AUC0-t = 58.77 ± 13.02μg · m L-1 · H, AUC0-∞ = 60.50 ± 13.71μg · m L-1 · h. The main pharmacokinetic parameters of moxifloxacin hydrochloride tablets under postprandial conditions were Tmax = 2.66 ± 1.48 h and Cmax = 3.16 ± 0.70μg · M L-1, AUC0-t = 57.01 ± 9.95 μg · m L-1 · h, AUC0-∞ = 59.00 ± 10.60 μg · m L-1 · h. Conclusions Compared with fasting condition, there is no significant difference in pharmacokinetic parameters except postprandial Tmax, which indicates that food may slow the absorption of moxifloxacin hydrochloride.