高效液相色谱法测定人血浆中氨溴素及药物动力学研究  

Determination of Ambroxol in Human Plasma by HPLC and Its Pharmacokinetics Study

作　　者：张昕[1] 谭力[1] 袁倚盛[1] 

机构地区：[1]南京军区南京总医院中心仪器分析室

出　　处：《中国药科大学学报》1998年第4期305-307,共3页Journal of China Pharmaceutical University

摘　　要：建立了高效液相色谱法测定正常人口服盐酸氨溴素缓释胶囊后的血药浓度。血样经碱化后乙醚提取，盐酸反提后进样，以甲醇－０．０１ｍｏｌ／Ｌ磷酸盐缓冲液（ｐＨ７．３）－四氢呋喃（７０∶２７．５∶２．５，ｖ／ｖ）为流动相，利多卡因作为内标，在２４８ｎｍ处定量检测。本法线性范围宽（１０．０～２００．０ｎｇ／ｍｌ，ｒ＝０．９９９４），回收率稳定（８７．２％±２．８％），精确度高（日内ＲＳＤ＜４．１％，日间ＲＳＤ＜８．１％）。测定了健康受试者口服盐酸氨溴素缓释胶囊的血药浓度。An accurate and sensitive assay for ambroxol in human plasma has been developed using reverse phase high performance liquid chromatography Plasma samples were prepared for analysis by addition of internal standard lidocaine, alkalization with carbonate buffer(pH 10), extraction of diethyl ether and then followed by extraction with hydrochloric acid An ALLTECH C 18 column, a methanol 0 01 mol/L phosphate buffer(pH 7 3) tetrahydrofuran mixture(70∶27 5∶2 5) as the mobile phase and the UV detector(set at 248 nm) were used The calibration curve was linear in the range from 10 ng/ml to 200 ng/ml with r =0 9994 The averaged recovery of ambroxol was 87 2%±2 8% The relative standard deviations for within day and between day were ≤4 1% and ≤8 1%, respectively Following oral administration of 75 mg ambroxol hydrochloride in ten volunteers, the peak levels of ambroxol in plasma averaged 163 1±16 6 ng/ml at 3 9±0 3 h

关 键 词：氨溴素 高效液相色谱 药物动力学 祛痰药 

分 类 号：R974.1[医药卫生—药品]