普罗布考片单次口服给药的人体药物代谢动力学研究_向瑾.pdfVIP

2012 27 West China Medical Journal Vol.27 No.7 Jul. 2012 975 - HPLC-MS/MS 2010 10 11 24 0.5 gHPLC-MS/MS DAS 2.0 11.50 ± 6.66h2 894.72 ± 1 320.53ng/mL- AUC0-t 238 876.96 ± 131 873.67ng/mL hAUC0-∞259 989.08 ± 146 112.88ng/mL h278.52 ± 164.72 h A Pharmacokinetics of Single-dose Probucol Tablet in Healthy VolunteersXIANG Jin, XU Nan, YU Qin, WANG Ying, LIANG Mao-zhi, MIAO Jia, NAN Feng, SHEN Qi, QIN Yong-ping. Institute of Drug Clinical Trial GCP Center, Department of Clinical Pharmacology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China Corresponding author: LIANG Mao-zhi, E-mail: tayler22@163.com Abstract Objective To study the pharmacokinetics of probucol tablet in healthy volunteers with high performance liquid chromatography–electrospray tandem mass spectrometry (HPLC-MS/MS). MethodsTwenty-four healthy male volunteers were enrolled in the study during October and November in 2010. The subjects were orally administered a single dose of 0.5 g probucol tablet. The concentrations of probucol were assessed with HPLC-MS/MS method and data were analyzed automatically with DAS 2.0 Pharmacokinetic Program. ResultsThe parameters of probucol tablet were as following: the time to peak plasma concentration was (11.50 ± 6.66) hours, the peak plasma concentration was (2 894.72 ± 1 320.53) ng/mL, the area under the plasma concentration- time curve (AUC)0-t was (238 876.96 ± 131 873.67) ng/mL h, AUC0-∞ was (259 989.08 ± 146 112.88) ng/mL h and the half- time was (278.52 ± 164.72) hours. ConclusionProbucol conforms to a two-compartment open model and a single dose possesses a good safety in healthy volunteers. Key wordsProbucol; High