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目的研究乳酸卡德沙星氯化钠注射液在健康人体内连续给药的药代动力学特征。方法 12名受试者同时予以乳酸卡德沙星氯化钠注射液进行连续静滴(每次400 mg,恒速静滴2 h,每天1次,给药7 d),观察给药前后临床症状、体征、实验室指标,重点观测QT间期及糖耐量。用高效液相色谱法测定给药后不同时间的血浓度,求主要药代动力学参数。结果给药后,尿常规、血生化、心电图、糖耐量试验等亦未见有临床意义的异常的改变。出现1例与药物可能有关的轻度不良反应,停药后2日恢复正常。未见严重的药物不良反应。血药浓度约在第3天达稳态,Cmax为(7.01±1.19)mg.L-1,Cav为(2.15±0.34)mg.L-1,AUCss为(55.99±9.84)mg.L-1.h,Accumulation_Index为(1.08±0.05),DF为(310.97±9.854)。结论连续静滴乳酸卡德沙星在体内无蓄积,受试者耐受性良好。
Objective To study the pharmacokinetics of cardafloxacin sodium chloride injection in healthy volunteers. Methods Twelve subjects were given continuous intravenous drip (400 mg each time, intravenous drip for 2 hours at a constant rate for 7 days) with Ca (superscript 2) Symptoms, signs, laboratory indicators, focusing on observation of QT interval and glucose tolerance. The blood concentration of different time after administration was determined by high performance liquid chromatography, and the main pharmacokinetic parameters were obtained. Results After administration, urinary routine, blood biochemistry, electrocardiogram, glucose tolerance test, etc. also did not see the clinical significance of abnormal changes. A case of mild adverse reactions may occur with the drug, returned to normal after 2 days of withdrawal. No serious adverse drug reactions. The plasma concentration reached the steady state on the third day with the Cmax of (7.01 ± 1.19) mg.L-1, Cav of (2.15 ± 0.34) mg.L-1 and AUCss of (55.99 ± 9.84) mg.L-1 .h, Accumulation_Index was (1.08 ± 0.05) and DF was (310.97 ± 9.854). Conclusion Continuous intravenous infusion of doxycycline lactate in the body without accumulation, subjects were well tolerated.