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氨麻苯美片在健康人体内药动学和生物等效性
Pharmacokinetics and Bioequivalence of Paracetamol,Pseudoephedrine Hydrochloride,Diphenhydramine Hydrochloride and Dextromethorphan Hydrobromide Tablets in Healthy Volunteers
【摘要】 20名健康志愿者按两个制剂双周期交叉试验设计口服2种氨麻苯美片,采用HPLC-MS/MS法测定血浆中的伪麻黄碱、苯海拉明和O-去甲右美沙芬,采用HPLC-UV法测定血浆中的对乙酰氨基酚,结果表明:受试制剂中对乙酰氨基酚、伪麻黄碱、苯海拉明和O-去甲右美沙芬的相对生物利用度分别为(104.2±10.4)%、(107.4±17.9)%、(106.0±23.1)%和(106.5±17.4)%,表明两种氨麻苯美片具有生物等效性。
【Abstract】 A randomized single-dose cross-over design was used for the evaluation of two brands of paracetamol,pseudoephedrine hydrochloride,diphenhydramine hydrochloride and dextromethorphan hydrobromide tablets in 20 healthy volunteers.Pseudoephedrine,diphenhydramine and dextrorphan were determined by LC-MS/MS while paracetamol was determined by HPLC-UV.The relative bioavailability of paracetamol,pseudoephedrine,diphenhydramine and dextrorphan were(104.2±10.4)%,(107.4±17.9)%,(106.0±23.1)% and(106.5±17.4)%,respectively.The results demonstrated that the two preparations were bioequivalent.
【Key words】 paracetamol; pseudoephedrine; diphenhydramine; dextrorphan; pharmacokinetics; bioequivalence; LC-MS/MS; HPLC;
- 【文献出处】 中国医药工业杂志 ,Chinese Journal of Pharmaceuticals , 编辑部邮箱 ,2011年03期
- 【分类号】R969
- 【下载频次】121