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目的:比较2种司帕沙星胶囊的人体药动学参数、生物利用度,评价二者的生物等效性。方法:22名男性健康志愿者随机交叉单剂量口服200mg受试制剂或参比制剂后,应用高效液相色谱法测定血浆中司帕沙星浓度,并利用3p97程序计算药动学参数及评价二者生物等效性。结果:受试制剂与参比制剂体内药-时曲线符合二室模型,Cm ax分别为(0.85±0.23)、(0.90±0.27)μg.mL-1,tm ax分别为(5.59±2.28)、(4.95±1.17)h,AUC0~120分别为(27.92±6.09)、(29.65±8.49)μg.h.mL-1,AUC0~∞分别为(29.95±6.51)、(31.74±9.38)μg.h.mL-1。受试制剂相对生物利用度为(97.47±18.32)%。结论:受试制剂与参比制剂具有生物等效性。
OBJECTIVE: To compare the pharmacokinetic parameters and bioavailability of two sparfloxacin capsules and evaluate their bioequivalence. Methods: Twenty-two male healthy volunteers were randomized to receive oral single oral dose of 200 mg of test formulation or reference formulation, plasma concentration of sparfloxacin was determined by HPLC, and pharmacokinetic parameters were calculated using 3p97 program Bioequivalence. Results: The drug-time curve of the test preparation and the reference preparation conformed to the two-compartment model with Cm ax of (0.85 ± 0.23), (0.90 ± 0.27) μg.mL-1 and (tm ax) of 5.59 ± 2.28 (4.95 ± 1.17) h, AUC0 ~ 120 were (27.92 ± 6.09) and (29.65 ± 8.49) μg.h.mL-1 respectively, and the AUC0 ~ ∞ were (29.95 ± 6.51) and (31.74 ± 9.38) μg.h .mL-1. The relative bioavailability of the test preparation was (97.47 ± 18.32)%. Conclusion: The test preparation and the reference preparation are bioequivalent.