空腹和餐后口服盐酸莫西沙星片的人体生物等效性

发布时间：2018-05-05 16:44

本文选题：盐酸莫西沙星 + 空腹　；参考：《中国医院药学杂志》2017年11期

【摘要】：目的:在空腹和餐后条件下研究单次口服国产与进口盐酸莫西沙星片的生物等效性。方法:采用2制剂、2周期、2序列、随机交叉的试验设计,各24名健康男性志愿者分别在空腹和餐后服用受试制剂或参比制剂400 mg后,采用高效液相色谱-荧光检测法(HPLC-FLD)测定莫西沙星的血药浓度。采用WinNonlin6.4软件,非房室模型法计算主要药动学参数,药动学参数AUC_(0-t)和C_(max)对数转化后,以(1-2α)置信区间进行生物等效性评价。结果:在空腹和餐后条件下健康男性受试者口服国产和进口盐酸莫西沙星片后莫西沙星的AUC_(0-t)、AUC_(0-∞)和C_(max)几何均数比值(GMR)的90%置信区间均在80.00%~125.00%的范围内。餐后给药与空腹给药相比,t_(max)延长,C_(max)降低,而AUC和t_(1/2)基本一致。结论:在空腹和餐后条件下国产和进口盐酸莫西沙星片具有生物等效性。
[Abstract]:Aim: to study the bioequivalence of domestic and imported moxifloxacin hydrochloride tablets in fasting and postprandial conditions. Methods: a randomized crossover trial was conducted with 2 preparations and 2 cycles of 2 cycles. 24 healthy male volunteers were treated with 400 mg trial or reference preparation on an empty stomach and after a meal, respectively. The plasma concentration of moxifloxacin was determined by HPLC-FLD. The main pharmacokinetic parameters were calculated by using WinNonlin6.4 software and non-atrioventricular model method. After logarithmic transformation of the main pharmacokinetic parameters AUC _ S _ (0-t) and C _ (max), the bioequivalence was evaluated with the confidence interval of 1-2 伪). Results: the 90% confidence intervals of domestic and imported moxifloxacin tablets in healthy male subjects on fasting and postprandial conditions were in the range of 80.000% and 125.00% respectively. Compared with fasting drug administration, postprandial administration of the drug was significantly lower than that of postprandial administration, while AUC was almost the same as that of T _ S _ 2 (2 / 2). Conclusion: domestic and imported moxifloxacin hydrochloride tablets are bioequivalent under fasting and postprandial conditions.
【作者单位】：锦州医科大学航天中心医院研究生培养基地;航天中心医院临床药理室;
【分类号】：R969

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