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复方曲尼司特片人体药动学及生物等效性研究
Pharmacokinetics and Bioequivalence of Compound Tranilast Tablets
【摘要】 考察了22名男性健康受试者采用随机交叉单剂量口服复方曲尼司特片(受试制剂)和胶囊(参比制剂)后的药动学和生物等效性。采用LC-MS/MS法测定人血浆中曲尼司特和沙丁胺醇的浓度。曲尼司特和沙丁胺醇的相对生物利用度分别为(107.4±16.8)%和(105.9±18.6)%,结果表明两制剂生物等效。
【Abstract】 According to a randomized crossover design, the pharmacokinetics and bioequivalence after oral administration of a single dose of compound tranilast tablets (test preparation) and capsules (reference preparation) in 22 healthy male volunteers were investigated. The concentrations of tranilast and salbutamol were determined by LC- MS/MS. The relative bioavailability of tranilast and salbutamol were (107.4 ± 16.8) % and (105.9 ± 18.6) %. The results showed that the two preparations were bioequivalent.
【关键词】 曲尼司特；
沙丁胺醇；
药动学；
生物等效性；
液相色谱-串联质谱；
【Key words】 tranilast； salbutamol； pharmacokinetics； bioequivalence； LC-MS/MS；
【Key words】 tranilast； salbutamol； pharmacokinetics； bioequivalence； LC-MS/MS；
- 【文献出处】 中国医药工业杂志 ,Chinese Journal of Pharmaceuticals , 编辑部邮箱 ,2009年06期
- 【分类号】R969
- 【下载频次】133