文章摘要
刘灵晔,李娟,曹蓓,杨元勋,钱薇.盐酸左氧氟沙星片在健康人体内的药代动力学和 生物等效性研究[J].药学与临床研究,2020,28(2):89~92
盐酸左氧氟沙星片在健康人体内的药代动力学和 生物等效性研究
Pharmacokinetics and Bioequivalence Assessment of Levofloxacin Hydrochloride Tablets in Chinese Healthy Volunteers
投稿时间:2019-10-25  修订日期:2020-04-23
DOI:
中文关键词: 盐酸左氧氟沙星  药代动力学  生物等效性
英文关键词: Levofloxacin hydrochloride tablets  Pharmacokinetics  Bioequivalence
基金项目:
作者单位E-mail
刘灵晔 南京大学医学院附属鼓楼医院 liulingye66@163.com 
李娟 南京大学医学院附属鼓楼医院 juanli2003@163.com 
曹蓓 南京大学医学院附属鼓楼医院  
杨元勋 南京大学医学院附属鼓楼医院  
钱薇 南京大学医学院附属鼓楼医院  
摘要点击次数: 1003
全文下载次数: 989
中文摘要:
      目的:研究已上市盐酸左氧氟沙星片在健康中国人体内的生物等效性。方法:48例健康志愿者随机分组,分别在空腹及进食高脂餐后,两周期双交叉单剂量口服盐酸左氧氟沙星片及其参比制剂左氧氟沙星片各500 mg,采用高效液相色谱-串联质谱法测定给药前与给药后48 h内不同时间点的血药浓度,计算主要药代动力学参数,评价生物等效性。结果:在空腹试验中,盐酸左氧氟沙星片及其参比制剂的AUC0~48 h分别为(50.0±8.4)、(48.8±8.6) μg·h·mL-1,Cmax分别为(6.15±1.42)、(5.98±1.55) μg·mL-1,tmax分别为(1.19±0.62)、(1.30±0.73) h,t1/2分别为(6.56±1.13)、(6.51±1.14) h-1,相对生物利用度为(103.0±8.7)%;在餐后试验中,盐酸左氧氟沙星片及其参比制剂的AUC0~48 h分别为(45.4±8.4)、(44.5±8.2) μg·h·mL-1,Cmax分别为(5.85±1.08)、(6.58±1.89) μg·mL-1,tmax分别为(1.93±0.72)、(1.82±0.81) h,t1/2分别为(6.69±0.81)、(6.63±0.76) h-1,相对生物利用度为(102.3±5.3)%。结论:盐酸左氧氟沙星片与其参比制剂具有生物等效性。
英文摘要:
      Objective: To reevaluate the bioequivalence of post-marketing levofloxacin hydrochloride tablets. Methods: In a randomized, two cross-over, single-dose administration, 48 healthy volunteers were given 500 mg dose of levofloxacin hydrochloride tablets or reference preparations after fasting or high fat meals. Plasma concentrations at different time points before and after the administration were determined by high performance liquid chromatography-tandem mass spectrometry, to calculate the main pharmacokinetic parameters and evaluate the bioequivalence. Results: In the fasting test, the main pharmacokinetic parameters of the test and the reference tablets were as follows: AUC0-48 h (50.0±8.4) and (48.8±8.6) μg·h·mL-1, Cmax (6.15±1.42) and (5.98±1.55) μg·mL-1, tmax (1.19±0.62) and (1.30±0.73) h, t1/2 (6.56±1.13) and (6.51±1.14) h-1, respectively. The relative bioavailability was (103.0±8.7)%. In the high fat test, the main pharmacokinetic parameters of the test and the reference tablets were as follows: AUC0-48 h (45.4±8.4) and (44.5±8.2) μg·h·mL-1, Cmax (5.85±1.08) and (6.58±1.89) μg·mL-1, tmax (1.93±0.72) and(1.82±0.81) h, t1/2 (6.69±0.81) and (6.63±0.76) h-1, respectively. The relative bioavailability was (102.3±5.3)%. Conclusion: Levofloxacin hydrochloride tablets are bioequivalent to the reference preparations.
查看全文   查看/发表评论  下载PDF阅读器
关闭