000000c6罗红霉素与氨溴索体内相互作用研究.docVIP

罗红霉素与氨溴索体内相互作用研究 彭文兴＊ 李焕德 王峰 苏芬丽 （中南大学湘雅二医院临床药学教研室，湖南，长沙，410011） 摘要 目的：研究复方罗红霉素氨溴索片中二药在体内是否存在药动学上相互作用。方法：24名健康男性志愿者，采用4×4交叉试验设计，每组1人，交叉服用复方罗红霉素氨溴索片、罗红霉素片加氨溴索片、罗红霉素片、氨溴索片，服药后不同时间点取肘静脉血4～5mlLC－MS）90%的可信区间进行药物发生相互作用是否具临床意义的判定。结果：复方制剂、合用药物以及单用药物药动学参数均无显著性差异。无论是复方或是合用两种药物，均未在体内产生有临床意义的药物相互作用。结论：罗红霉素氨溴索片中二种成份在体内的吸收速度和程度与单一成份相比，不发生改变。二者在体内不产生统计学上和临床意义的相互作用。 关键词： 药动学， 药物相互作用， 罗红霉素， 氨溴索 作者简介：颜素华，主管药师，从事临床药学及合理用药工作。 *通讯作者：彭文兴，男，中南大学湘雅二医院临床药学研究室，副教授，研究方向：临床药代动力学和药物相互作用，Tel: (0731)5292097, Fax: (0731)4896038, E-mail: pwx.csu@163.com Study on pharmacokinetic interaction between roxithromycin and ambroxol in human Peng Wenxing Li Huande, Wang Feng, Clinical Pharmacy research institute, The Second Xiangya hospital, Central South University, Changsha, 410011, China Abstract Objective To evaluate whether it has pharmacokinetic interaction happened when volunteers oral administrated roxithromycin- ambroxol tablets (complex prescription). Methods?The study was conducted in a self-controlled, four-period cross-over experiment in 24 healthy volunteers. the volunteers received complex prescription roxithromycin-ambroxol tablets(roxithromycin 300mg, ambroxol 60mg), or co-administration roxithromycin tablets(300mg) and ambroxol tablets(60mg), or roxithromycin tablets (300mg) , or ambroxol tablets(60mg) for 7 consecutive?days, on the 7th day Serial blood samples were drawn at before and 0.5，1, 1.5, 2, 3, 4, 6, 8, 12, 24,36，48, 72h after drug administration. Concentrations of roxithromycin and ambroxol in plasma were measured by high-performance liquid chromatography- electrospray ionization tandem mass spectrometry (HPLC-ESI-MS). Non-compartmental analysis was used to characterize roxithromycin or ambroxol plasma concentration-time profiles, and comparisons of mean values were analyzed by the analysis of variance, Differences were considered to be significant at p??0.05. drug-drug interaction is test by 90% confidence interval. Results?The pharmacokinetic parameters of roxithromycin or