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目的:研究注射用盐酸帕洛诺司琼在健康受试者体内的药动学特征。方法:健康受试者静脉给与帕洛诺司琼,采集血样利用HPLC/MS测定药物浓度,进行数据分析计算药动学参数。结果:健康受试者静脉给与帕洛诺司琼0.25mg后,C0为(1.54±0.46)ng·mL-1,t1/2为(41.90±11.90)h,AUC0～t为(11.39±4.54)h.ng·mL-1,AUC0→∞为(14.44±5.45)h·ng·mL-1,Vd为(18.75±4.28)L·kg-1,CL为(5.68±2.56)mL·min·kg-1。结论:帕洛诺司琼体内分布广,清除较慢,体内半衰期长。健康受试者静脉注射帕洛诺司琼个体间存在着差异,性别间无差异。
Objective: To study the pharmacokinetics of palonosetron hydrochloride for injection in healthy volunteers. Methods: The healthy volunteers were given palonosetron intravenously. The blood samples were taken for determination of drug concentration by HPLC / MS. The pharmacokinetic parameters were calculated by data analysis. Results: After taking 0.25 mg palonosetron intravenously in healthy subjects, C0 was (1.54 ± 0.46) ng · mL-1, t1 / 2 was (41.90 ± 11.90) h, AUC0-t was (11.39 ± 4.54 ), the mean value of AUC0 → ∞ was (14.44 ± 5.45) h · ng · mL-1, the value of Vd was (18.75 ± 4.28) L · kg-1 and the value of CL was (5.68 ± 2.56) mL · min · h · ng · mL- kg-1. Conclusion: Palonosetron is widely distributed in vivo and has a slower clearance and longer half-life in vivo. There was a difference in the individual between Palonosetron and IV in healthy subjects, with no difference between the sexes.