人体血浆中卡维地洛固相萃取-HPLC-荧光测定法及其生物等效性研究  

Determination of Carvedilol and Its Bioequivalence in Human Plasma by HPLC Using Solid-Phase Extraction

作　　者：夏春华[1] 熊玉卿[1] 章新晶[1] 胡晓[1] 李艳艳[1] 

机构地区：[1]江西医学院临床药理研究所,南昌330006

出　　处：《中国药学杂志》2006年第9期692-694,共3页Chinese Pharmaceutical Journal

摘　　要：目的建立一种固相萃取-HPLC-荧光检测法,以测定人体血浆中卡维地洛的药物浓度,并对两制剂生物等效性进行评价。方法18名健康受试者单剂量交叉po 25 mg卡维地洛供试片或参比片后不同时间点采血,其血样经固相萃取后,采用高效液相色谱-荧光检测法测定其浓度,计算其药动学参数和相对生物利用度,评价两制剂的生物等效性。结果卡维地洛供试片与参比片AUC_(0～24)分别为(201.20±90.60)和(183.80±68.55)μg·h·L^(-1),ρ_(max)分别为(48.86±15.58)和(44.06±15.82)μg·L^(-1),t_(max)分别为(0.9±0.3)和(1.0±0.5)h,t_(1/2ke)分别为(6.92±1.00)和(6.91±1.47)h。两制剂主要药动学参数经统计学分析无显著性差异。结论该方法简便灵敏,两制剂具有生物等效性。OBJECTIVE To establish a HPLC method for the pharmacokinetics and bioequivalence of carvedilol in human. METHODS The carvedilol in plasma extracted with solid phase column was determined by a HPLC-fluorescence method following a single oral dose of 25 mg of carvedilol test tablet and reference tablet given respectively to 18 healthy male volunteers in an open randomized crossover design. The pharrnacokinetic parameters and relative bioavailability were calculated to evaluate the bioequivalence of 2 preparations. RESULTS The AUC0-24 of carvedilol test tablet and reference were（201.20 ± 90.60） and（ 183.80 ± 68.55）μg·h·L^-1,ρmax were（48.86±15.58） and （44.06 ± 15.82）μg·L^- 1, tmax were （0.9 ± 0.3） and（ 1.0 ± 0.5） h, t1/2ke were（6.92 ± 1.00） and（6.91 ± 1.47） h, respectively. These main pharmacokinetic parameters obtained showed no statistically significant difference between 2 products. CONCLUSION The method is simple and sensitive. Both preparations are bioequivalent.

关 键 词：卡维地洛 高效液相色谱法 药动学 生物等效性 

分 类 号：R969[医药卫生—药理学]