HPLC法测定中国健康人血浆中依帕司他浓度及药动学研究  

HPLC Determination of Plasma Epalrestat and Its Pharmacokineticsin Chinese Healthy Subjects

作　　者：谢一凡[1] 陈聪颖[1] 荣征星[1] 赵咏桔[2] 吴兰风[1] 陈泽乃[1] 陆阳[1] 陈红专[1] 

机构地区：[1]上海第二医科大学药物研究所,上海200025 [2]瑞金医院内分泌科

出　　处：《上海第二医科大学学报》2003年第6期502-504,共3页Acta Universitatis Medicinalis Secondae Shanghai

摘　　要：目的建立血浆中依帕司他的HPLC测定方法,研究依帕司他胶囊在中国健康男性的药动学特性。方法HPLC测定以地西泮作内标,测定20名健康志愿受试者口服50 mg依帕司他胶囊后血药浓度-时间过程。用非房室模型参数估算法计算药动学参数。 结果方法回收率大于90％,日内、日间变异系数均低于5％,线性范围20.2～8080 ng/ml(r=0.9996,n=5),最低检测浓度2ng/ml,符合生物样品的分析要求。 结论本研究建立的HPLC测定方法专属性较好,血浆中杂质不干扰样品的测定,适合于依帕司他的临床药动学研究。Objective A high performance liquid chromogragpy ( HPLC ) method was established to study the pharmacokinetics of epalrestat in Chinese healthy subjects. Methods Diazepam was used as the internal standard. The pharmacokinetics of epalrestat in 20 Chinese healthy subjects was studied after oral administration of 50 mg. The pharmacokinetic parameters were calculated according to non - compartment model. Results Recoveriy of epalrestat from plasma was more than 90% , and the relative standard deviation ( RSD) of intraday and interday was all less than 5% . The calibration curves were linear over 20. 2 - 8080 ng/ml ( r = 0. 9996 , n = 5 ) and the minimum detection concentration was 2ng/ml. Conclusion The established HPLC assay was accurate and convenient for clinical pharmacokinetic study of epalrestat.

关 键 词：HPLC法 测定 中国健康人 血浆 依帕司他 浓度 药动学 

分 类 号：R969[医药卫生—药理学]