空腹和餐后口服盐酸莫西沙星片的人体生物等效性  

Bioequivalence of moxifloxacin hydrochloride tablets in healthy volunteers under fasting and fed conditions

作　　者：武丽原 王晓琳[2] 邓鸣[2] 刘曼[2] 刘会臣[2] 

机构地区：[1]锦州医科大学航天中心医院研究生培养基地,北京100049 [2]航天中心医院临床药理室,北京100049

出　　处：《中国医院药学杂志》2017年第11期1038-1042,共5页Chinese Journal of Hospital Pharmacy

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。OBJECTIVE To study the bioequivalence of domestic and imported moxifloxacin hydrochloride tablets under fasting and fed conditions.METHODS Two formulations, randomized, two-period crossover clinical trials were performed. Twenty four healthy male volunteers were given a single oral dose of 400 mg of domestic or imported moxifloxacin hydrochloride tablets under fasting and fed conditions, respectively. Moxifloxacin in plasma were determined by a HPLC-FLD method. By means of WinNonlin Ver 6.4 software, pharmacokinetic parameters were calculated using a non-compartmental mode. The 90% confidence intervals （90% CIs） of the test-to-reference geometric mean ratio （GMR） of AUC and Cmaxwere calculated to assess the bioequivalence.RESULTS The 90% CIs of the GMR of AUC0-t, AUC0-∞and Cmax between the test and reference drug fell within the limit ranges of 80.00%-125.00% under fasting and fed conditions, respectively. Cmax decreased and tmaxdelayed, AUC and t1/2 of moxifloxacin were basically the same under fed condition compared to the fasting conditions.CONCLUSION The domestic moxifloxacin tablets are proved to be bioequivalent to imported moxifloxacin hydrochloride tablets both under fasting and fed conditions

关 键 词：盐酸莫西沙星 空腹 餐后 液相色谱-荧光检测法 生物等效性 

分 类 号：R969[医药卫生—药理学]