2种盐酸左氧氟沙星胶囊的人体生物等效性研究

目的:研究2种盐酸左氧氟沙星胶囊的人体生物等效性。方法:22名健康男性志愿者,采用单剂量、随机、自身交叉对照试验设计,分别空腹口服盐酸左氧氟沙星胶囊受试制剂和参比制剂各200mg后,用反相高效液相色谱-荧光检测法检测血清中左氧氟沙星经-时过程的血药浓度,计算其药动学参数和相对生物利用度。结果:受试制剂与参比制剂的Cm ax分别为(2 840.7±371.6)、(2 810.5±440.0)ng.mL-1,t1/2β分别为(7.26±1.21)、(7.28±1.58)h,tm ax分别为(1.13±0.44)、(1.09±0.34)h,AUC0~24分别为(20 908.9±3 178.2)、(20 398.0±2 576.4)ng.h.mL-1,AUC0~∞分别为(23 173.6±3 600.4)、(22 492.4±2 649.0)ng.h.mL-1。受试制剂的相对生物利用度为(103.1±14.1)%。结论:2种盐酸左氧氟沙星胶囊具有生物等效性。

Studies on the Bioequivalence of 2 Kinds of Levofioxacin Hydrochloride Capsules in Healthy Male Volunteers

OBJECTIVE: To study the bioequivalence of 2 kinds of levofloxacin hydrochloride capsules in healthy male volunteers were studied.METHODS: In a randomized two-period cross-over study,a single oral dose of 200mg levofloxacin capsule(test and reference preparation) were given to 22 healthy male volunteers.The serum concentrations of levofloxacin were determined by RP-HPLC-fluorescence method.The pharmacokinetic parameters of the two preparations and the relative bioavailability of levofloxacin were calculated with statistical analysis.RESULTS: The pharmacokinetic parameters of the test and control preparation were as follows: Cmax were(2 480.7± 371.6) and(2 810.5± 440.0) ng· mL-1,t1/2β were(7.26± 1.21) and(7.28± 1.58) h,tmax were(1.13± 0.44) and(1.09± 0.34) h,AUC0～ 24 were(20 908.9± 3 178.2) and(20 398.0± 2 576.4) ng· h· mL-1,AUC0～ ∞ were(23 173.6± 3 600.4) and(22 492.4± 2 649.0) ng· h· mL-1.The relative bioavailability of levofloxacin in test were(103.1± 14.1) %.CONCLUSION: The two preparations were bioequivalent.