复方罗红霉素片多剂量给药在健康志愿者体内的药动学  

Pharmacokinetics of Complex Prescription of Roxithromycin Tablets by Multiple Dose of Administration in Healthy Volunteers

作　　者：任秀华[1] 申玲玲[1] 向道春[1] 刘宇[1] 陈倩[1] 张冬林[1] 方淑贤[1] 刘东[1] 杜光[1] 

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430030

出　　处：《医药导报》2011年第8期1003-1006,共4页Herald of Medicine

摘　　要：目的研究复方罗红霉素片多剂量给药在健康志愿者体内的药动学。方法 24例健康成年志愿者,男女各半,采用随机分组平行设计,分别多剂量口服复方罗红霉素片、罗红霉素片150 mg+盐酸氨溴索片30 mg,采用串联质谱法测定血浆中罗红霉素和氨溴索的浓度,采用DAS2.1程序分别计算各受试者的药动学参数,并用配对t检验对罗红霉素或氨溴索进行分析。结果复方罗红霉素片组与两单药合用组相比,罗红霉素和氨溴索的人体药动学参数均差异无统计学意义,复方罗红霉素片中罗红霉素和氨溴索的主要药动学参数Cmax分别为(6 261.67±2 111.12)和(51.42±19.83)ng.mL-1t,1/2分别为(14.70±8.91)和(10.19±1.94)h,AUC0→t分别为(96 055.25±38 428.39)和(679.86±183.90)μg.L-1.h,AUCss分别为(47 767.15±16 097.92)和(372.53±119.18)μg.L-1.h。结论多剂量给予复方罗红霉素片后,与两单药合用的对照药的药动学特征差异无统计学意义。Objective To study the pharmacokinetics of complex prescription of roxithromycin tablets （I） by multiple dose of administration in healthy volunteers. Methods The total of 24 healthy volunteers were randomly divided into two groups with twelve each, and given with multiple dose of I or roxithromycin tablets plus ambroxol hydrochloride tablets （II）, respectively. The concentration of roxithromycin or ambroxol in plasma was determined by LC-MS/MS separately. The pharmacokinetie parameters were calculated with DAS 2.1 practical program and evaluated by t-test. Results The Cmax,t1/2, AUC（0-t） and AUCs of roxithromycin and ambroxol of I were（ 6 261.67±2 111.12 ） and 51.42±19.83 ng·mL^-1, （ 14.70± 8.91） and （10.19±1.94） h, （96 055.25±38 428.39） and （679.86±183.90） ng · mL^-1·h^-1, （47 767.15±16 097.92） and （372.53± 119. 18 ） ng · mL^-1·h^-1, respectively. Conclusion Compared with II, the pharmaeokinetic parameters of roxithromycin and ambroxol of I showed no significant difference.

关 键 词：罗红霉素片 复方 罗红霉素 氨溴索 液相色谱串联 质谱法 

分 类 号：R969.1[医药卫生—药理学]