RP-HPLC测定人血浆中非那甾胺的含量及其药代动力学研究  

Determination of Finasteride and Its Pharmacokinetics in Human Plasma by HPLC

作　　者：夏春华[1] 熊玉卿[1] 李艳艳[1] 

机构地区：[1]江西医学院临床药理学研究所,南昌330006

出　　处：《中国药科大学学报》2004年第2期187-189,共3页Journal of China Pharmaceutical University

摘　　要：目的 :建立反相高效液相色谱法测定人体血浆中非那甾胺的药物浓度 ,并对供试制剂与参比制剂的生物等效性进行评价。方法 :本试验血样处理采用固相萃取法 ,流动相为 15mmol/LKH2 PO4 乙腈 (用浓磷酸调pH为 2 85 ) ( 5 7∶4 3) ,色谱柱为ODSC18柱 ,检测波长为 2 15nm。人体药代动力学实验采用双周期交叉设计方案 ,将 2 0名志愿受试者随机分为 2组 ,分别口服非那甾胺供试片和对照片 10mg。结果 :线性范围为 2～ 12 8ng/mL ,最低检测限为 2ng/ml,方法回收率为 10 1 4± 2 7% ,RSD <5 % ,两制剂主要药代动力学参数经统计学分析无显著性差异。结论 :方法可用于非那甾胺的含量测定。AIM:A HPLC method was established for the study of pharmacokinetics and bioavailability of finasteride in human METHOD:A solid phase extraction procedure was used to isolate finasteride from the human plasma which was analyzed on diamonsil ODS C 18 column and detected at 215 nm The mobile phase was 15 mmol/L KH 2 PO 4 (pH 2 85,adjusted with H 3 PO 4 ) acetonitrile(43∶57) A single oral dose of 10 mg of two preparations was given to each 20 volunteers in an open randomized two way crossover design RESULT:The linear range was 2～128 ng/ml and limit determination was 2 ng/ml The method recovery was (101 4±2 7)% and RSD was less than 5% The main pharmacokinetic parameters obtained showed no statistically significant difference between two preparations CONCLUSION:HPLC method was specific,sensitive,reproducible for the determination of finasteride in human plasma Two products were bioequivalent

关 键 词：非那甾胺 高效液相色谱法 药代动力学 含量测定 

分 类 号：R96[医药卫生—药理学]