血浆尿嘧啶核苷测定及胞磷胆碱钠片和胶囊人体生物等效性研究  

Determination of uridine in human plasma and bioequivalence evaluation of CDP-choline capsules and tablets

作　　者：曹明亮[1,2] 陈克广[1] 刘晓燕[3] 王本杰[3] 魏春敏[3] 袁桂艳[3] 郭瑞臣[3] 

机构地区：[1]山东大学药学院,济南250012 [2]泰山医学院药学院药物分析教研室,山东泰安271000 [3]山东大学齐鲁医院临床药理研究所,济南250012

出　　处：《山东大学学报（医学版）》2011年第5期156-159,162,共5页Journal of Shandong University:Health Sciences

摘　　要：目的建立人血浆尿嘧啶核苷高效液相色谱测定法,进行胞磷胆碱钠健康志愿者生物等效性研究。方法 24例健康志愿者口服胞磷胆碱片或胶囊600m g,以阿莫西林为内标,采用高效液相色谱法测定尿嘧啶核苷经时血浓度,DAS软件计算尿嘧啶核苷主要药代动力学参数,评价两制剂的生物等效性。结果尿嘧啶核苷回归方程为y=2.10x＋0.57（r=0.992 8）,方法最低检测限为0.05μg/mL,回收率95.57%～102.09%,日内、日间RSD均小于15%。血浆尿嘧啶核苷药后3.5h达峰值,约为3.0μg/mL,然后逐渐降低,约8h至基础值。AUC0-t、AUC0∞和Cmax90%置信区间分别为85.3%97.5%、85.3%～102.9%和89.5%～102.1%。结论所建立方法特异性强,灵敏度高,测定结果可靠,可用于人血浆嘧啶核苷测定。胞磷胆碱钠片和胶囊符合生物等效的假设,为生物等效制剂。Objective To establish a high performance liquid chromatography（HPLC） method for the determination of uridine in human plasma and to evaluate the bioequivalence of CDP-choline capsules and tablets.Methods Plasma concentrations of uridine were determined after a single oral dose of 600mg CDP-choline capsules and tablets by the established HPLC method with amoxicillin as the internal standard.Main pharmacokinetic parameters of uridine were calculated and bioequivalence of CDP-choline capsules and tablets were evaluated by DAS.Results The linear regression equation was y=2.10x＋0.57（r=0.992 8） within a range of 0.05-2 μg/mL.The lowest detection limit for uridine was 0.05 μg/mL,recoveries were 95.57%-102.09%,and inter-day and intra-day precisions were less than 15%.The concentration of plasma uridine reached a maximum of 3.0 μg/mL after 3.5 hours,and then slowly decreased to the base level after 8 hours.90% confidential intervals of AUC0-t,AUC0-∞ and Cmax were 85.3%-97.5%,85.3%-102.9% and 89.5%-102.1%,respectively.Conclusions The method is accurate,sensitive and suitable for the determination of uridine in human plasma.CDP-choline tablets and capsules are bioequivalent.

关 键 词：色谱法 高压液相 尿嘧啶核苷 胞磷胆碱 生物等效性 

分 类 号：R969.1[医药卫生—药理学]