乳酸左氧氟沙星片人体药物动力学及生物等效性研究  

Pharmacokinetics and bioequivalance of levofloxacin lactate in healthy volunteers

作　　者：况晓东[1] 夏春华[1] 章新晶[1] 熊玉卿[1] 傅军[1] 

机构地区：[1]江西医学院临床药理研究所,南昌330006

出　　处：《中南药学》2005年第4期226-228,共3页Central South Pharmacy

摘　　要：目的研究乳酸左氧氟沙星片在健康人体内的药物动力学,评价两种片剂的生物等效性。方法18名健康男性志愿者单次交叉口服乳酸左氧氟沙星供试制剂或参比制剂200mg,采用高效液相色谱荧光检测法测定血浆中左氧氟沙星的浓度,计算其药物动力学参数和相对生物利用度,评价两制剂的生物等效性。结果供试制剂和参比制剂实测AUC0～24分别为(17.83±1.80)、(18.35±2.00)μg·h·mL-1,cmax分别为(3.14±0.75)、(3.03±0.61)μg·mL-1,tmax分别为(0.9±0.4)h和(1.0±0.4)h,t1/2分别为(6.57±0.69)h和(6.43±0.54)h。供试制剂相对于参比制剂的生物利用度为(98.0%±12.3%)。结论两制剂具有生物等效性。OBJECTIVE To study the pharmacokinetics of two levofloxacin tablets, and to evaluate the bioequivalance of the two preparations. METHODS A single oral dose of 200 mg of test or reference preparation was given to 18 healthy male volunteers according to an open randomized crossover study. The plasma concentration of levofloxacin was determined by HPLC-fluorescence method. The parameters of pharmacokinetic and relative bioavailitivity were calculated, the bioequivalance of the two preparations were analysed. RESULTS The main pharmacokinetic parameters of the test and the reference preparations were as follows： Cmax was （3. 14±0. 75）μg·mL^-1 and （3.03±0.61）μg·mL^-1; tmas （0.9±0.4） hand （1.0±0.4） h; t1/2 was （6.57±0. 69） hand （6.43±0. 54） h；AUC0-24 was （17. 83±1.80）μg·mL^-1 and （18.35±2.00）μg·mL^-1. The relative bioavailability of test to reference preparation was （98. 0±12. 3%）. CONCLUSIONS The two preparations were bioequivalent.

关 键 词：乳酸左氧氟沙星 高效液相色谱法 药物动力学 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R978[医药卫生—药学]