乳酸左氧氟沙星片的生物等效性研究

目的：建立人血浆中乳酸左氧氟沙星的HPLC-MS测定方法,研究乳酸左氧氟沙星在正常人体内的药代动力学行为,评价我公司生产的乳酸左氧氟沙星片与上市产品来立信的生物等效性。方法：人体实验采用双交叉设计,22名健康受试者交叉口服两个厂家生产的乳酸左氧氟沙星片,服药后0.33h～24h内间隔取血,用HPLC-MS法测血浆中的左氧氟沙星浓度,计算主要药动学参数,以上市样品为参比制剂,估算我公司生产的样品的相对生物利用度,判断生物等效性。结果：我公司研制的乳酸左氧氟沙星片相对生物利用度为108.1%～123.3%。结论：本实验建立的分析方法灵敏、准确、简便,统计学结果表明两种制剂生物等效。

Bioequivalent of Levofloxacin Lactate tablets in human

Aim:To develop a HPLC-MS method for determination of Levofloxacin Lactate in human plasma and to investigate the pharmacokinetics and bioequivalence of Levofloxacin Lactate tablets . Methods: A randomized crossover desigh was performed in 22healthy volunteers. A single 200mg dose of Levofloxacin Lactate tablets produced by two pharmaceutical co. was administrated to each volunteer. Determin the concentration of Levofloxacin in plasma by HPLC-MS. The main pharmacokinetic parameters of Levofloxacin and the bioequivalence of its two preparations were calculated. Results:The relative bioavailability of the Levofloxacin Lactate tablets was 108.1~123.3%. Conclusion: The assay was shown to be sensitive,accurate and convenient.The two Levofloxacin Lactate tablets were bioequivalent.