论文部分内容阅读
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 study the bioequivalence of two levofloxacin lactate tablets in healthy volunteers. Methods A randomized, double-crossover self-controlled trial was designed. Twenty-four healthy volunteers were randomized to receive a single oral dose of 200 mg of the test formulation and reference formulation. The concentration of levofloxacin in the plasma was determined by HPLC-UV method. The pharmacokinetic parameters were calculated and the bioequivalence of the two preparations was evaluated. Results The main pharmacokinetic parameters of levofloxacin lactate tablets and reference preparations were as follows: Tmax were (0.97 ± 0.47), (1.11 ± 0.47) h, Cmax were (2587.09 ± 703.87), (2215.54 ± 427.96) ng / mL; t1 / 2 were (7.93 ± 1.16) and (7.89 ± 1.23) h, AUC0-t were (19481.36 ± 2675.32) and (18793.04 ± 2595.71) h.ng/mL respectively; AUC0- ± 2798.09), (19602.06 ± 2774.75) h / (ng / mL). The calculated relative bioavailability of levofloxacin lactate tablets with AUC0-t was (104.7 ± 15.3)%. Conclusion Both formulations are bioequivalent in healthy volunteers.