血浆中西沙必利胶囊的HPLC法分析及生物等效性研究  

Determination and Bioequivalent Study of Cisapride in Human Plasma by HPLC

作　　者：傅军[1] 熊玉卿[1] 

机构地区：[1]江西医学院临床药理研究所,南昌330006

出　　处：《药物分析杂志》2001年第4期258-260,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的 :建立人血浆西沙必利的反相高效液相色谱荧光检测分析方法 ,并对其在人体内的生物等效性进行研究。方法 :血浆样品在碱性条件下经三氯甲烷 -异丙醇 (9∶1)提取 ,用KromasilC18柱 ,乙腈 - 0 0 5mol·L-1磷酸盐缓冲液 -三乙胺 (39∶6 0∶1)为流动相 ,流速 1 0mL·min-1,荧光检测激发波长 2 72nm ,发射波长 35 0mm等条件下 ,分析测定。结果 :西沙必利在 2 5～ 12 0 μg·L-1浓度范围内呈良好线性关系 (r =0 9992 )。血浆最低检出浓度为 1ng·mL-1。结论 :本法准确灵敏 ,重现性好 ,可用于西沙必利的药代动力学研究。Objective:To establish HPLC method for determination and bioequivalent study of cisapride in human plasma.Methods:The blood samples were extracted with chloroform-isopropanol(9∶1).The Kromasil C 18 column was used as analytical column.The mobile phase consisted of acetonitrile -0 05 mol·L -1 phosphate buffer -triethylamine (39∶60∶1).The flow rate was 1 0 mL·min -1 with fluorescence monitoring at 272 nm(excitation)and 350 nm(emission).Results:The linear range of cisapride was 2 5～120 μg·L -1 ( r= 0 999 2)and determination limit was 1 ng·mL -1 .Conclusion:The method had a good sensitivity and reproducibility and can be used for pharmacokinetic studies of cisapride in human plasma.

关 键 词：西沙必利 高效液相色谱法 药代动力学 生物等效性 胃肠道动力剂 

分 类 号：R975[医药卫生—药品] R969.1[医药卫生—药学]