普卢利沙星胶囊的人体生物等效性研究  

Study on Bioequiavailability of Prulifloxacin Capsules in Human Bodies

作　　者：邓英贤[1] 文爱东[2] 王志睿[2] 陈苏宁[2] 吴寅[2] 周敏[2] 李薇[2] 

机构地区：[1]空军总医院药剂科,北京100036 [2]解放军第四军医大学西京医院药剂科,陕西西安710032

出　　处：《解放军药学学报》2007年第1期29-32,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的评价口服普卢利沙星胶囊的人体生物等效性。方法采用随机、交叉试验设计,20名男性健康志愿者交叉空腹口服两种普卢利沙星制剂264.2mg(相当于活性成份200mg)。用HPLC法测定普卢利沙星代谢产物NM394体内的血药浓度。结果受试制剂和参比制剂其主要药动学参数T1/2分别为(8.88±2.85)、(9.08±3.07)h;Cmax分别为(1.04±0.39)、(0.94±0.30)mg·L-1,Tmax分别为(0.66±0.15)、(0.64±0.15)h,AUC0-t分别为(6.89±2.18)、(6.66±1.93)mg·L-·1h,AUC0-∞分别为(7.73±2.56)、(7.57±2.19)mg·L-·1h,MRT分别为(9.82±1.51)、(9.65±1.90)h,经方差分析和双单侧t检验,主要药动学参数无显著性差异;受试制剂的相对生物利用度为(105.7±24.2)%。结论两种普卢利沙星制剂在健康人体内具有生物等效性。Aim To investgate the bioequivalence of tested and reference prulifloxacin preparation in 20 male and healthy volunteers. Methods A single oral dose of 264.2 mg（ equivalent to 200 mg of NM394） tested and reference prulifloxacin was given to 20 volunteers in a randomized cross-over on an empty stomach. The plasma concentration of NM394 （ an active metabolite of prulifloxacin） was determined by HPLC. Results The main pharmaco- kinetic parameters of the tested and reference agents were as follows ： T 1/2 was （8.88 ± 2.85 ） h and （9.08 ± 3.07 ） h, respectively; C max was（ 1.04 ±0.39） mg·L^-1 and（0.94 ±0, 30） mg·L^-1 , respectively; Tmax（0.66 ±0.15 ） h and （0.64 ± 0.15 ） h, respectively ; AUC0.1 was （ 6.89 ± 2.18 ） mg·L^-1. h and （ 6.66 ± 1.93 ） mg. L^ - 1. h, respectively; AUC0.1 was （7.73 ± 2.56 ） mg·L^-1.h and （ 7.57 ± 2.19） mg. L^-.h, respectively; MRT was （9.82 ± 1.51 ） h and （9.65 ± 1.90）h, respectively. There was no significant difference in main pharmacokinetic parameters between two preparations from ANOVA and two-one side t-tests. The relative bioavailability of the tested prulifloxacin capsules was（ 105.7 ± 24.2）%. Conclusion The results of statistic analysis demonstrated that the two prulifloxacin preparations were bioequiavalent in healthy human bodies.

关 键 词：普卢利沙星 NM394 生物等效性 HPLC 

分 类 号：R969[医药卫生—药理学]