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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。
OBJECTIVE: To establish a HPLC-MS method for the determination of levofloxacin lactate in human plasma. To study the pharmacokinetics of levofloxacin lactate in normal human and to evaluate the bioequivalence of levofloxacin lactate tablets and its listed product. Methods: Two-crossover design was used in human experiment. Levofloxacin lactate tablets were produced from two manufacturers at the crossing of 22 healthy subjects. Blood samples were collected at intervals of 0.33 h to 24 h after drug administration. The concentration of levofloxacin in plasma was calculated by HPLC-MS The main pharmacokinetic parameters to the listed samples for the reference preparation, the company estimated the relative bioavailability of the sample, to determine the bioequivalence. Results: The relative bioavailability of levofloxacin lactate tablets developed by our company ranged from 108.1% to 123.3%. Conclusion: The analytical method established in this experiment is sensitive, accurate and simple, and the statistical results show that the two preparations are bioequivalent.