盐酸左氧氟沙星胶囊的人体生物等效性研究

Study on the Bioequivalence of Levofloxacin Hydrochloride Capsules in Healthy Volunteers

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18名健康男性受试者随机交叉单剂量口服盐酸左氧氟沙星胶囊受试制剂或参比试剂,采用反相高效液相色谱法测定血药浓度,计算其药动学参数和相对生物利用度,评价其生物等效性。结果受试制剂和参比制剂的tm ax分别为(1.0±0.1)h和(1.0±0.1)h,Cm ax分别为(3.1±0.7)μg.mL-1和(3.3±0.9)μg.mL-1,t1/2分别为(6.8±1.4)h和(6.9±1.7)h,AUC0-t分别为(20.7±6.1)μg.h.mL-1和(20.1±5.4)μg.h.mL-1,AUC0-∞分别为(22.1±6.1)μg.h.mL-1和(21.6±5.5)μg.h.mL-1,受试制剂的相对生物利用度为(103.0±8.2)%。结论盐酸左氧氟沙星2种制剂具有生物等效性。

OBJECTIVE To study the bioequivalence of 2 kinds of levofloxacin hydrochloride capsules. METHODS 18 healthy male volunteers were administered orally with single dose of either the tested or the referenced formulations by randomized crossover way. The blood concentrations of Levofloxacin hydrochloride were determined by RP-HPLC, and the pharmacokinetics parameters and the relative bioavailability were calculated. RESULTS The tmax of the tested and referenced formulations were （ 1.0 ± 0.1 ） h and （ 1.0 ± 0.1 ） h, respectively Cmax were （ 3.1 ± 0.7 ） μg·mL^-1 and （ 3.3 ± 0.9 ） μg·mL^-1, t1/2 were （ 6.8 ± 1.4） h and （ 6.9 ± 1.7 ） h, AUC0-t were （20.7 ±6.1） μg·h·mL^-1 and （20.1 ±5.4） μg·h·mL^-1, AUC0-t were （22.1 ±6.1） μg·h·mL^-1 and （21.6 ± 5.5 ） μg·h·mL^-1, the relative bioavailability of tested to referenced capsules was （ 103.0 ± 8.2 ） %. CONCLUSION The 2 kinds of levofloxacin hydrochloride capsules are bioequivalent.