齐拉西酮片在健康人体内的药动学研究  

Pharmacokinetics Study of Ziprasidone Tablets in Chinese Healthy Volunteers

作　　者：朱永坚[1] 陈清霞[2] 刘伟忠[1] 邱梅[1] 王广发[3] 吴曙光[3] 

机构地区：[1]广州市脑科医院国家药品临床研究基地,广州510370 [2]中山大学附属第二医院药学部,广州510120 [3]南方医科大学药学院,广州510515

出　　处：《中国药房》2013年第46期4364-4366,共3页China Pharmacy

摘　　要：目的:研究齐拉西酮片在健康人体内的药动学。方法:20名健康志愿者单剂量口服齐拉西酮片40 mg,分别于服药前及服药后0、0.5、1、2、3、4、5、6、8、12、16、24、36、48 h时采集肘静脉血,用高效液相色谱法测定受试者血浆中齐拉西酮浓度,药动学参数用DAS 2.0软件统计处理。结果:齐拉西酮片药-时曲线经拟合呈一房室模型;主要药动学参数cmax为(167.74±58.43)ng/ml,tmax为(3.72±1.86)h,t1/2为(5.57±1.63)h,AUC0-48 h为(1 285±252.59)ng·h/ml,AUC0-∞为(1 396±276.54)ng·h/ml。结论:齐拉西酮片在健康人体内的药动学呈一房室模型,本试验可为临床用药提供药动学参数。OBJECTIVE： To study the pharmacokinetics of Ziprasidone tablets in healthy volunteers. METHODS： 20 healthy subjects received a single oral dose of ziprasidone tablets 40 mg. Blood samples of ulnar vein were taken before medication and 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 h after medication. The plasma concentrations of ziprasidone were determined by HPLC. Pharmacokinetic parameters were analyzed by DAS 2.0 software. RESULTS： Plasma concentration-time curves of ziprasidone conformed to one-compartment model. Main pharmacokinetics parameters of ziprasidone were as follow： Cmax was（167.74 ± 58.43）ng/mL, tmax was（3.72 ± 1.86）h, t1/2 was（5.57 ± 1.63）h, AUC0-48 h was（1 285 ± 252.59）ng.h/ml, AUC0-∞ was（1 396.75 ± 276.54）ng. h/ml, respectively. CONCLUSIONS： The pharmacokinetics of ziprasidone in human volunteers conforms to one-compartment model. The study can provide reference for the clinical application of ziprasidone.

关 键 词：齐拉西酮 药动学 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学] R974.1[医药卫生—药学]