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

作　　者：张运好[1] 胡玉钦[1] 张伟东[2] 侯艳宁[1] 

机构地区：[1]白求恩国际和平医院,河北石家庄050082 [2]河北医科大学,河北石家庄050017

出　　处：《中国医药工业杂志》2011年第3期201-205,共5页Chinese Journal of Pharmaceuticals

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。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.

关 键 词：对乙酰氨基酚 伪麻黄碱 苯海拉明 O-去甲右美沙芬 药动学 生物等效性 液相色谱-串联质谱 高效液相色谱法 

分 类 号：R969[医药卫生—药理学]