HPLC法测定人血浆中顺铂的浓度及其药动学研究  

Determination of Cisplatin Concentration in Human Plasma by HPLC and Pharmacokinetic Study

作　　者：薛晖[1] 陈荣[1] 李洁[1] 

机构地区：[1]常州市第一人民医院,江苏常州213003

出　　处：《中国药房》2012年第38期3593-3595,共3页China Pharmacy

摘　　要：目的:建立测定非小细胞肺癌患者静脉滴注小剂量顺铂后血浆中药物浓度的方法,并分析其药动学特点。方法:15名非小细胞肺癌化疗患者静脉滴注小剂量顺铂,动态采集患者给药前及末次给药后96h内的血浆样本,以高效液相色谱(HPLC)法测定顺铂的血药浓度,DAS软件计算药动学参数。结果:顺铂血药浓度在0.16～4mg.L-1范围内线性关系良好,相对回收率为96.60%～113.95%,日内、日间RSD均在10%以内。顺铂的药动学模型为开放二室模型,药动学参数分别为:消除半衰期(t1/2β)(62.89±10.84)h,表观分布容积(V)(13.39±4.86)L,清除率(CL)(1.42±0.57)L.h-1,药-时曲线下面积(AUC)(74.24±43.83)mg.h.L-1。结论:HPLC法测定顺铂血药浓度,操作简单易行,重现性好,符合血药浓度监测及人体内药动学研究要求。OBJECTIVE： To determine the plasma concentration of cisplatin in patients with non-small-cell lung carcinoma （NSCLC） after small-dose intravenous injection of cisplatin, and to analyze pharmacokinetic characteristics of it. METHODS： 15 NSCLC patients were given small-dose of cisplatin by intravenous drip infusion. The plasma samples of patients were collected dy- namically before administration and in 96 h after last administration. HPLC method was used to determine plasma concentration of cisplatin, and DAS software was used to calculate pharmacokinetic parameters. RESULTS： The linear range of cisplatin was 0.16~ 4 mg·L^-1 with relative recovery of 96.60% ~ 113.95%. The RSDs of intra-day and inter-day were less than 10%. The pharmacoki- netic profile of cisplatin was best described by an open two-compartment model. Pharmacokinetic parameters were as follows： t1/2p （62.89 ± 10.84）h; V（13.39 ± 4.86）L; CL（1.42 ± 0.57）L-h^-1; AUC（74.24 ± 43.83）mg. h. L^-1. CONCLUSIONS： HPLC developed for the determination of plasma concentration is simple, easy and reproducible, and it is suitable for plasma drug concentration monitoring and human pharmacokinetic study.

关 键 词：顺铂 非小细胞肺癌 药动学 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学] R979.1[医药卫生—药学]