论文部分内容阅读
目的建立测定甲磺酸帕珠沙星血浆药物浓度的HPLC-UV检测法,研究国产甲磺酸帕珠沙星氯化钠注射液在人体内的药物动力学。方法12名健康志愿受试者单次静滴甲磺酸帕珠沙星氯化钠注射液500 mg,以盐酸芦氟沙星为内标,测定血浆中帕珠沙星的浓度,用DAS 1.0软件处理经时血药浓度数据,计算主要药物动力学参数。结果单次静滴甲磺酸帕珠沙星氯化钠注射液500 mg后,于给药后0.50 h达到峰浓度9.83±2.52 mg.L-1,AUC0-t为18.99±4.15 mg.h.L-1,T1/2β为2.67±0.31 h,Cl/F和V/F分别为23.73±3.81 L.h-1和1.16±0.31 L.kg-1。结论单次静滴甲磺酸帕珠沙星氯化钠注射液的体内过程符合二室开放模型;除AUC外,男、女受试者的其余药动学参数比较,差异无统计学意义。
Objective To establish a HPLC-UV method for the determination of pazufloxacin mesylate in human plasma and study the pharmacokinetics of pazufloxacin mesylate sodium chloride injection in human. Methods Twelve healthy volunteers were infused intravenously with pazufloxacin mesylate sodium chloride 500 mg once daily to determine the concentration of pazufloxacin in the plasma with rufloxacin hydrochloride as the internal standard. The software processes the blood concentration data over time and calculates the main pharmacokinetic parameters. Results After a single intravenous infusion of pazufloxacin mesylate sodium chloride 500 mg, the peak concentration was 9.83 ± 2.52 mg.L-1 at 0.50 h and the AUC0-t was 18.99 ± 4.15 mg.hL- 1, T1 / 2β was 2.67 ± 0.31 h, Cl / F and V / F were 23.73 ± 3.81 Lh-1 and 1.16 ± 0.31 L.kg-1, respectively. Conclusion The single intravenous infusion of pazufloxacin mesylate sodium chloride injection in vivo is in accordance with the two-compartment open model. There is no significant difference in the remaining pharmacokinetic parameters between male and female subjects except AUC.