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

山东大学学报(医学版) ›› 2011, Vol. 49 ›› Issue (5): 156-.

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

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

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

收稿日期:2010-12-23 出版日期:2011-05-10 发布日期:2011-05-10
通讯作者: 郭瑞臣，男，教授，博士研究生导师，研究方向为临床药理学和药代动力学。 E-mail:grc7636@126.com
作者简介:曹明亮（1981- ），男，讲师, 主要从事药物分析研究。

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

CAO Ming-liang1,2, CHEN Ke-guang1, LIU Xiao-yan3, WANG Ben-jie3, WEI Chun-min3, YUAN Gui-yan3, GUO Rui-chen3

1. Faculty of Pharmacy, Shandong University, Jinan 250012, China;
2. Faculty of Pharmacy, Taishan Medical University, Taian 271000, Shandong China;
3. Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China

Received:2010-12-23 Online:2011-05-10 Published:2011-05-10

摘要/Abstract

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600mg，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=0.9928），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。

关键词: 色谱法，高压液相；尿嘧啶核苷；胞磷胆碱；生物等效性

Abstract:

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=0.9928) within a range of 0.05-2μg/mL.The lowest detection limit for uridine was 0.05μg/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 3.0μg/mL after 3.5 hours, and then slowly decreased to the base level after 8 hours. 90% confidential intervals of AUC_0-t, AUC_0-∞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.

Key words: Chromatography, high performance liquid; Uridine; CDP-choline; Bioequivalence

中图分类号:

R969.1

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. 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[J]. 山东大学学报(医学版), 2011, 49(5): 156-.

CAO Ming-liang1,2, CHEN Ke-guang1, LIU Xiao-yan3, WANG Ben-jie3, WEI Chun-min3, YUAN Gui-yan3, GUO Rui-chen3. Determination of uridine in human plasma and bioequivalence evaluation of CDP-choline capsules and tablets[J]. JOURNAL OF SHANDONG UNIVERSITY (HEALTH SCIENCES), 2011, 49(5): 156-.

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