盐酸左氧氟沙星片人体药动学及生物等效性研究

目的:研究2种盐酸左氧氟沙星片在人体内的药动学及生物等效性。方法:采用随机自身交叉对照试验设计,20名健康男性志愿者分别单剂量口服受试制剂与参比制剂后,采用高效液相色谱法测定血浆左氧氟沙星的浓度,并计算二者药动学参数及生物利用度。结果:受试制剂与参比制剂Cmax分别为(6.54±1.39)、(6.31±1.21)mg·L-1,tmax分别为(1.04±0.39)、(1.04±0.40)h,t1/2分别为(7.77±0.84)、(7.98±1.30)h,AUC0~24分别为(50.66±5.84)、(50.94±4.82)mg·h·L-1,AUC0~∞分别为(57.55±6.75)、(58.42±6.40)mg·h·L-1。以AUC0~24估算,受试制剂的相对生物利用度为(100.20±14.23)%。结论:二者生物等效。

Pharmacokinetics and Bioequiavailability of Levofioxacin Tablets in Healthy Volunteers

OBJECTIVE: To study the pharmacokinetics and bioequiavailability of 2 kinds of levofloxacin tablets in healthy volunteers.METHODS: A single dose of test and reference tablets of levofloxacin were given to 20 healthy male volunteers in a randomized cross-over study.Plasma level of levofloxacin were detected by HPLC and the pharmacokinetic parameters and bioequiavailability of 2 kinds of levofloxacin tablets were computed.RESULTS: The main pharmacokinetic parameters of the test and the reference preparations were as follows: Cmax were(6.54±1.39) mg·L-1 and(6.31±1.21) mg·L-1;tmax were(1.04±0.39)h and(1.04±0.40)h;t1/2 were(7.77±0.84)h and(7.98±1.30)h;AUC0～24 were(50.66±5.84) mg·h·L-1 and(50.94±4.82) mg·h·L-1;AUC0～∞ were(57.55±6.75) mg·h·L-1 and(58.42±6.40) mg·h·L-1,respectively.Estimated by AUC0～24,the relative bioavailability of the test preparation was(100.20±14.23)%.CONCLUSION: The result of statistical analysis showed that test and the reference tablets of levofloxacin were bioequivalent.