盐酸左氧氟沙星软胶囊、硬胶囊和片剂的人体药动学研究  

Pharmacokinetics of levofloxacin hydrochloride soft capsules, hard capsules and tablets in Chinese healthy volunteers

作　　者：储继红[1] 居文政[1] 许美娟[1] 吴婷[1] 魏熹[2] 谈恒山[3] 蒋萌[1] 熊宁宁[1] 

机构地区：[1]南京中医药大学附属医院临床药理科 [2]中国药科大学 [3]南京军区南京总医院临床药理科

出　　处：《中国临床药理学与治疗学》2007年第6期710-713,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的:使用HPLC法测定人血浆中左氧氟沙星的浓度,并研究盐酸左氧氟沙星软胶囊、硬胶囊和片剂在健康人体内的药代动力学。方法:20名健康男性志愿者单剂量口服200mg盐酸左氧氟沙星后,采集不同时间点血样测定血药浓度。结果:左氧氟沙星线性范围为0.041～5.180mg/L,日内和日间精密度(RSD)均小于5.0%。盐酸左氧氟沙星软胶囊主要药动学参数:tmax:(0.8±0.3)h;Cmax:(2.8±0.9)mg/L;AUC0-30:(14.7±1.8)mg·L-1.h;AUC0-∞:(15.4±1.9)mg·L-1.h;t1/2:(6.9±0.4)h。结论:盐酸左氧氟沙星软胶囊的药动学参数与硬胶囊和片剂的差异无统计学意义。To establish a HPLC method for the determination of levofloxacin in plasma and to investigate the pharmacokinetics of levofloxacin hydrochloride soft capsules, hard capsules and tablets in Chinese healthy volunteers. METHODS： 20 male healthy subjects were received a single oral dose of 200 mg levofloxacin. The concentrations of levofloxacin in plasma were determined by HPLC. RESULTS： The linear range of levofloxacin was between 0.041 mg/L and 5.18 mg/L. The inter-day and intra-day RSD were less than 5 %. The main pharmacokinetic parameters of levofloxacin soft capsulewere as follows： tmax：（0.8±0.3）h;Cmax：（2.8±0.9）mg/L;AUC0-30：（14.7±1.8）mg·L^-1.h;AUC0-∞：（15.4±1.9）mg·L^-1.h;t1/2：（6.9±0.4）h. There were no statistically significant differences among the main pharmacokinetic parameters of levofloxacin hydroehloide soft capsule hard capsule and tablet.CONCLUSION： The main pharmacokinetic parameters of levofloxacin hydrochloride soft capsules were similar to fllose of hard capsule and tablet.

关 键 词：盐酸左氧氟沙星 软胶囊 HPLC法 药动学 

分 类 号：R969.1[医药卫生—药理学]