HPLC-MS-MS测定盐酸西替利嗪血药浓度及药动学研究  

Determination of Serum Concentration of Cetirizine Hydrochloride Tablets by HPLC-MS-MS and Its Pharmacokinetics

作　　者：廖日房[1] 叶琳[1] 温预关[2] 

机构地区：[1]中山大学附属第二医院临床药学部,广州市510120 [2]广州市脑科医院临床药理研究基地,广州市510370

出　　处：《中国医院用药评价与分析》2008年第10期756-759,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：广东省医院药学研究基金(2008B001);广州市医药卫生科技计划(2007-YB-106)

摘　　要：目的:研究国产盐酸西替利嗪咀嚼片的人体药动学。方法:选择20名男性健康志愿者,采用HPLC-MS-MS测定单剂量(20mg)口服国产盐酸西替利嗪咀嚼片后,西替利嗪在人体内的浓度。结果:盐酸西替利嗪的体内动态过程呈一级吸收的二房室开放模型,Cmax,、Tmax、T1/2、AUC0-36、AUC0-∞分别为209.97±28.26μg·h·L-1,1.6±0.3h,9.18±3.44h,1545.5±441.5μg·h·L-1,1633.4±479.0μg·h·L-1。结论:国产盐酸西替利嗪片与进口片具有生物等效性。OBJECTIVE： To study the pharmacokinetics of Cetirizine Hydrochtoride Tablets in healthy volunteers. METHODS ： HPLC - MS - MS was applied for the determination of serum concentration of Cetirizine in 20 healthy volunteers after a single oral dose of 20 mg domestic Cetirizine Hydroehloride Tablets. RESULTS： The dynamic process of Cetirizine conformed to a two- compartment open model （first order absorption）. The main pharmacokinetie parameters of domestic Cetirizine Hydrochloride were as follows： C T T1/2 , AUC0-36, AUC0- 330 and Cmax were 209.97±28.26μg·L^-1,1.6±0.3h,9.18±3.44h,1545.5±441.5μg·h·L^-1,1633.4±479.0μg·h·L^-1, respectively. CONCLUSION ： The domestic Cetirizine Hydrochloride and imported Cetirizine Hydrochloride Tablets are bioequivalent.

关 键 词：盐酸西替利嗪 药动学 高效液相色谱法 生物利用度 

分 类 号：R986[医药卫生—药品]