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齐拉西酮片在健康人体内的药动学研究
引用本文:朱永坚,陈清霞,刘伟忠,邱梅,王广发,吴曙光. 齐拉西酮片在健康人体内的药动学研究[J]. 中国药房, 2013, 0(46): 4364-4366
作者姓名:朱永坚  陈清霞  刘伟忠  邱梅  王广发  吴曙光
作者单位:[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
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40mg,分别于服药前及服药后0、0.5、1、2、3、4、5、6、8、12、16、24、36、48h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DAS2.0软件统计处理。结果:齐拉西酮片药-时曲线经拟合呈-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,AUC0-48h为(1285±252.59)ng·h/ml,AUC0-∞为(1396±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。

关 键 词:齐拉西酮  药动学  高效液相色谱法

Pharmacokinetics Study of Ziprasidone Tablets in Chinese Healthy Volunteers
ZHU You-jian,CHEN Qing-xia,LIU Wei-zhong,QIU Mei,WANG Guang-fa,WU Shu-guang. Pharmacokinetics Study of Ziprasidone Tablets in Chinese Healthy Volunteers[J]. China Pharmacy, 2013, 0(46): 4364-4366
Authors:ZHU You-jian  CHEN Qing-xia  LIU Wei-zhong  QIU Mei  WANG Guang-fa  WU Shu-guang
Affiliation:1. State Base of Drug Clinical Study, Guangzhou Brain Hospital, Guangzhou 510370, China; 2. Dept. of Pharmacy, The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou 510120, China; 3. School of Pharmaceutical Sciences, Southern Medical University, Guangzhou 510515, China)
Abstract: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.
Keywords:Ziprasidone  Pharmacokinetics  HPLC
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