【摘要】：目的:評價注射用鹽酸苯達莫司汀在腫瘤患者體內(nèi)的藥動學特征。方法:10例受試者接受120 mg·m-2鹽酸苯達莫司汀慢速靜脈滴注,以苯達莫司汀中間體為內(nèi)標,采用高效液相法(HPLC)測定給藥后血漿藥物濃度,以DAS 2.1軟件進行藥動學參數(shù)的計算分析。結(jié)果:血藥濃度在5~10 000 ng·m L-1劑量范圍內(nèi)線性關系良好。靜脈滴注120 mg·m-2鹽酸苯達莫司汀(4 h),平均消除半衰期(t1/2)、達峰濃度(Cmax)、達峰時間(Tmax)及血藥濃度-時間曲線下面積(AUC0~t)分別為(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。受試者在研究期間未發(fā)生III度及以上不良反應。結(jié)論:本研究建立的檢測方法簡單快速,試劑消耗少,準確度及精密度良好,適合鹽酸苯達莫司汀人體藥動學研究。單次靜脈注射鹽酸苯達莫司汀,受試者耐受良好。
[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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