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目的:研究国产甲磺酸帕珠沙星注射液多次连续给药在健康人体内的药动学特点。方法:12例健康志愿者静滴甲磺酸帕珠沙星注射液500 mg,bid,连续5 d,并采用反相高效液相色谱法测定血药浓度数据,用DAS软件计算主要药动学参数。结果:静滴甲磺酸帕珠沙星药动学特点符合开放二室模型,第1次单次给药和最后1次给药的主要药动学参数如下:平均峰浓度分别为(10.86±2.04)和(11.72±1.82)mg.L-1,平均稳态药-时曲线下面积AUC0~∞分别为(18.29±2.36)和(19.22±2.80)mg.h.L-1,t1/2β分别为(1.64±0.27)和(1.82±0.34)h。结论:连续给药帕珠沙星5 d,受试者耐受良好,药动学过程符合二室模型,多次给药体内无蓄积。
Objective: To study the pharmacokinetics of domestic pazufloxacin mesylate multiple continuous administration in healthy volunteers. Methods: Twelve healthy volunteers were infused with pazufloxacin mesylate 500 mg twice daily for 5 d. The plasma concentration data were determined by RP-HPLC. The main pharmacokinetic parameters were calculated by DAS software parameter. RESULTS: The pharmacokinetics of pazufloxacin mesylate was in accordance with the open two-compartment model. The main pharmacokinetic parameters of the first single dose and the last dose were as follows: The average peak concentrations were (10.86 ± 2.04) and (11.72 ± 1.82) mg.L-1, respectively. The average steady-state drug-time curve AUC0 ~ ∞ were (18.29 ± 2.36) and (19.22 ± 2.80) mg.hL- (1.64 ± 0.27) and (1.82 ± 0.34) h respectively. CONCLUSION: Pazufloxacin is administrated continuously for 5 days, and the subjects are well tolerated. The pharmacokinetic process conforms to the two-compartment model and has no accumulation in multiple administrations.