注射用盐酸苯达莫司汀在肿瘤患者体内的药动学研究

发布时间：2019-07-10 15:16

【摘要】：目的:评价注射用盐酸苯达莫司汀在肿瘤患者体内的药动学特征。方法:10例受试者接受120 mg·m-2盐酸苯达莫司汀慢速静脉滴注,以苯达莫司汀中间体为内标,采用高效液相法(HPLC)测定给药后血浆药物浓度,以DAS 2.1软件进行药动学参数的计算分析。结果:血药浓度在5~10 000 ng·m L-1剂量范围内线性关系良好。静脉滴注120 mg·m-2盐酸苯达莫司汀(4 h),平均消除半衰期(t1/2)、达峰浓度(Cmax)、达峰时间(Tmax)及血药浓度-时间曲线下面积(AUC0~t)分别为(0.389±0.052)h、(2.2±0.8)μg·m L-1、(2.9±1.2)h、(6.7±1.8)μg·m L-1·h。受试者在研究期间未发生III度及以上不良反应。结论:本研究建立的检测方法简单快速,试剂消耗少,准确度及精密度良好,适合盐酸苯达莫司汀人体药动学研究。单次静脉注射盐酸苯达莫司汀,受试者耐受良好。
[Abstract]:Objective: to evaluate the pharmacokinetics of phenomolastine hydrochloric acid for injection in patients with tumor. Methods: the plasma drug concentration was determined by high performance liquid chromatography (HPLC) (HPLC) and the pharmacokinetics parameters were calculated and analyzed by DAS 2.1 software, and the plasma drug concentration was determined by high performance liquid chromatography (HPLC). The plasma drug concentration was determined by high performance liquid chromatography (HPLC). The plasma drug concentration was determined by high performance liquid chromatography (HPLC). The pharmacokinetics parameters were calculated and analyzed by DAS 2.1 software. Results: the linear range of blood concentration was 5 鈮，

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