文章摘要
王〓楠,张〓梦,杭太俊,张正行,张银娣,张劲松.罗红霉素氨溴索分散片在健康人体的药代动力学[J].南京医科大学学报,2009,29(10):1435~1439
罗红霉素氨溴索分散片在健康人体的药代动力学
Evaluation of pharmacokinetics of the dispersible tablet of roxithromycin and ambroxol hydrochloride in healthy volunteers
投稿时间:2009-01-21  
DOI:10.7655
中文关键词: 罗红霉素  盐酸氨溴索  药代动力学  LC-MS/MS
英文关键词: roxithromycin  ambroxol hydrochloride  pharmacokinetics  LC-MS/MS
基金项目:
作者单位
王〓楠 南京军区南京总医院药品科,江苏 南京〓210002 
张〓梦 上海市食品药品检验所,上海〓201203 
杭太俊 中国药科大学药物分析室,江苏 南京〓210009 
张正行 中国药科大学药物分析室,江苏 南京〓210009 
张银娣 南京医科大学临床药理研究所,江苏 南京〓210029 
张劲松 南京医科大学临床药理研究所,江苏 南京〓210029 
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中文摘要:
      目的:建立同时测定人血浆中罗红霉素和盐酸氨溴索的液相色谱-串联质谱联用法(LC-MS/MS),研究健康受试者口服罗红霉素盐酸氨溴索分散片(每片含罗红霉素150 mg?盐酸氨溴索30 mg)后的人体药代动力学?方法:12名健康受试者单剂量口服罗红霉素盐酸氨溴索分散片后72 h内间隔取血,用LC-MS/MS测定血浆样品药时过程,用DAS数据处理软件计算主要药代动力学参数?结果:罗红霉素的主要药动学参数Cmax,Tmax,t1/2z,MRT,AUC0-τ,CLz/F和Vz/F分别为(6.99±1.55)μg/ml,(2.04±0.94)h,(13.30±2.56)h,(14.31±2.51)h,(84.56±26.20)h·μg/ml,(1.88± 0.51)L/h和(35.06±8.68)L;盐酸氨溴索的分别为(53.91±22.41)ng/ml,(1.96±0.66)h,(8.24±2.01)h,(7.96±0.47)h,(447.98.±138.95)h·ng/ml,(61.85±14.79)L/h和(724.42±214.86)L?结论:血浆样品中罗红霉素和盐酸氨溴索同时测定LC-MS/MS法专属性强,灵敏度适宜?适用于罗红霉素盐酸氨溴索分散片药代动力学研究?
英文摘要:
      Objective:To establish a LC-MS/MS method for assessment of pharmacokinetics of dispersible tablet of roxithromycin and ambroxol hydrochloride (each containing roxithromycin 150 mg,ambroxol hydrochloride 30 mg). Methods:Each of 12 healthy Chinese volunteers was given a single oral dose of one tablet. Plasma samples were collected at 72 h post-administration and the concentrations were determined by LC-MS/MS. The pharmacokinetic parameters were calculated by DAS software. Results:The main pharmacokinetic parameters of Cmax,Tmax,t1/2z,MRT,AUC0-τ,CLz/F and Vz/F for roxithromycin were (6.99±1.55) μg/ml,(2.04±0.94) h,(13.30±2.56) h,(14.31±2.51) h,(84.56±26.20) h·μg/ml,(1.88± 0.51)L/h and (35.06±8.68)L,respectively;and those for ambroxol hydrochloride were (53.91±22.41) ng/ml,(1.96±0.66) h,(8.24±2.01) h,(7.96±0.47) h,(447.98.±138.95) h·ng/ml,(61.85±14.79)L/h and(724.42±214.86)L,respectively. Conclusion:The established LC-MS/MS method is selective,sensitive and reliable for the pharmacokinetic study of the dispersible tablet of roxithromycin and ambroxol hydrochloride.
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