多剂量甲磺酸帕珠沙星氯化钠注射液在健康人体的药代动力学  

Pharmacokinetics of multiple-dose pazufloxacin mesilate sodium chloride injection in Chinese healthy volunteers

作　　者：王进[1] 肖永红[1] 张薇[1] 吕媛[1] 康子胜[1] 张明[1] 刘燕[1] 夏亚红[1] 李天云[1] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034

出　　处：《中国临床药理学杂志》2007年第1期24-27,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究甲磺酸帕珠沙星氯化钠注射液(氟喹诺酮类抗生素)在健康人体内连续给药的药代动力学特征。方法12名受试者同时予以静滴甲磺酸帕珠沙星氯化钠注射液500mg,间隔12h,每日2次,连续7天,用高效液相色谱法测定给药后不同时间的血、尿浓度,求得主要药代动力学参数。结果其血药浓度约在第4天达稳态,Cmax为(13.46±1.87)mg·L-1,Cav为(2.72±0.36)mg·L-1,AUCss为(32.70±4.28)mg·L-1·h,DF为490.43%,FI为98.15%,尿中的药物累积排泄率>90%,与单次给药无明显差异。结论每日2次,静滴帕珠沙星500mg,连续7天,药物在体内无蓄积,受试者耐受性良好。Objective To evaluate the pharmacokinetics of multiple - dose pazufloxaein mesilate sodium chloride injection in Chinese health volunteers. Methods The serum and urine samples of 12 healthy volunteer were collected after injecting 500mg pazufloxacin mesilate sodium chloride injection for 7 days and were determined by HPLC method. Resuits The following pharmacokinetie parameters were calculated by DAS software, Cmax was （13.46 ±1.87） mg · L^-1,Cav was （2.72 ±0.36） mg ·L^-1,AUCss was（32.70 ±4.28） mg · h^-1· L^-1,DF was 490.43% , FI was 98.15%. The 12 hour cumulative urinary exeretionrates were 〉 90%. Conclusion There were no body cumulation after injecting 500 mg pazufloxaein mesilate sodium chloride twice per day for 7 days, the volunteers were safe.

关 键 词：甲磺酸帕珠沙星氯化钠注射液 高效液相色谱方法 连续给药 药代 动力学 

分 类 号：R969.1[医药卫生—药理学] R978.17[医药卫生—药学]