乳酸左氧氟沙星片在健康志愿者体内的生物等效性研究  

Bioequivalence of levofloxacin lactate tablets in healthy volunteers

作　　者：杜姗[1] 陈玺[1] 王凌王婷 蒋学华[1] 

机构地区：[1]四川大学华西药学院临床药学与药事管理学系,成都610041

出　　处：《中国抗生素杂志》2012年第2期123-126,共4页Chinese Journal of Antibiotics

摘　　要：目的研究两种乳酸左氧氟沙星片在健康志愿者体内的生物等效性。方法采用随机双交叉自身对照试验设计,24名健康志愿者随机交叉单剂量口服200mg受试制剂和参比制剂。采用HPLC-UV法测定受试者血浆中左氧氟沙星的浓度,计算药动学参数,评价两制剂的生物等效性。结果乳酸左氧氟沙星片受试制剂和参比制剂的主要药动学参数如下:Tmax分别为(0.97±0.47)、(1.11±0.47)h;Cmax分别为(2587.09±703.87)、(2215.54±427.96)ng/mL;t1/2分别为(7.93±1.16)、(7.89±1.23)h、AUC0-t分别为(19481.36±2675.32)、(18793.04±2595.71)h.ng/mL;AUC0-∞分别为(20323.35±2798.09)、(19602.06±2774.75)h/(ng/mL);以AUC0-t计算乳酸左氧氟沙星片受试制剂的相对生物利用度为(104.7±15.3)%。结论两种制剂在健康志愿者体内生物等效。Objective To investigate the bioequivalence of two different levofloxacin lactate tablets in healthy volunteers. Methods A single oral dose of 200mg of test and reference preparation was given respectively to 24 healthy male volunteers according to an open randomized crossover design. The plasma concentration of levofloxacin was determined by HPLC-UV method, the pharmacokinetic parameters were calculated and the bioequivalence of the two preparation was evaluated. Results The main pharmacokinetic parameters of 200mg of test and reference preparation were as followings： Tax were （0.97±0.47）h and （1.11±0.47）h; Cax were （2587.09±703.87）ng/mL and （2215.54±427.96）ng/mL; t1/2 were （7.93± 1.16）h and （7.89± 1.23）h; AUC0-1 were （19481.36±2675.32）h/（ng/mL） and （18793.04±2595.71）h.ng/mL; AUC0-∞ were （20323.35±2798.09）h/（ng/mL） and （19602.06±2774.75）h/（ng/mL）, respectively. The relative bioavailability oflevofloxacin lactate tablets was （104.7±15.3）%. Conclusion The results showed that the two preparation were bioequivalent.

关 键 词：左氧氟沙星 药动学 生物等效性 高效液相色谱-紫外检测法 

分 类 号：R978.11[医药卫生—药品]