| 双氯芬酸钠缓释片在健康人体的药代动力学和生物等效性 |
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| 引用本文： | 彭向东,周淦,谭志荣,陈姚,王医成,郭栋,曹杉,张伟,欧阳冬生,周宏灏.双氯芬酸钠缓释片在健康人体的药代动力学和生物等效性[J].中国新药杂志,2011(20). |
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| 作者姓名： | 彭向东 周淦 谭志荣 陈姚 王医成 郭栋 曹杉 张伟 欧阳冬生 周宏灏 |
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| 作者单位： | 中南大学临床药理研究所;中南大学湘雅三医院; |
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| 基金项目： | 中南大学基础研究基金(2010QZZD010) |
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| 摘 要： | 目的:评价双氯芬酸钠缓释片受试制剂和参比制剂在健康人体的药代动力学和生物等效性。方法:24例健康男性志愿者分别行单剂量和多剂量交叉口服双氯芬酸钠缓释片受试与参比制剂,用高效液相色谱-串联质谱法测定血浆中双氯芬酸钠的血药浓度,计算药代动力学参数及相对生物利用度。结果:单剂量口服受试制剂和参比制剂的主要药动学参数如下:Cmax分别为(568.38±271.26)和(458.64±173.96)ng.mL-1,Tmax分别为5(0.5,12)和1.5(0.5,7)h,AUC0～24 h分别为(2 557.72±659.43)和(2 364.14±698.08)ng.h.mL-1,AUC0～∞分别为(2 655.25±635.48)和(2 843.62±808.61)ng.h.mL-1,MRT分别为(6.3±1.8)和(7.0±1.7)h;多剂量口服受试制剂和参比制剂的主要药代动力学参数为:T(ss,max)分别为5(1,7)和4(0.5,8)h,C(ss,max)分别为(520.58±245.89)和(522.98±234.36)ng.mL-1,C(ss,min)分别为(24.96±20.79)和(22.68±17...
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| 关 键 词： | 高效液相色串联质谱法 药代动力学 生物等效性 双氯芬酸钠 缓释片 |
Pharmacokinetics and bioequivalence of diclofenac sodium sustained release tablets in healthy volunteers |
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| PENG Xiang-dong,ZHOU Gan,TAN Zhi-rong,CHEN Yao,WANG Yi-cheng,GUO Dong,CAO Shan,ZHANG Wei,OUYANG Dong-sheng,ZHOU Hong-hao.Pharmacokinetics and bioequivalence of diclofenac sodium sustained release tablets in healthy volunteers[J].Chinese Journal of New Drugs,2011(20). |
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| Authors: | PENG Xiang-dong ZHOU Gan TAN Zhi-rong CHEN Yao WANG Yi-cheng GUO Dong CAO Shan ZHANG Wei OUYANG Dong-sheng ZHOU Hong-hao |
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| Institution: | PENG Xiang-dong1,2,ZHOU Gan1,TAN Zhi-rong1,CHEN Yao1,WANG Yi-cheng1,GUO Dong1,CAO Shan1,ZHANG Wei1,OUYANG Dong-sheng1,ZHOU Hong-hao1(1 Institute of Clinical Pharmacology,Central South University,Changsha 410078,China,2 The Third Xiang-Ya Hospital of Central South University,Changsha 410013,China) |
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| Abstract: | Objective: To establish a HPLC-MS/MS method for simultaneous determination of diclofenac sodium in human plasma,and to evaluate the bioequivalence of diclofenac sodium sustained release tablets in 24 healthy volunteers.Methods: Healthy volunteers(n=24) were administrated with diclofenac sodium sustained release tablets in a randomized and two-way crossover design with single or multiple dosage.The plasma concentrations were determined by HPLC-MS/MS method.The pharmacokinetic parameters and bioequivalence we... |
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| Keywords: | HPLC-MS/MS pharmacokinetics bioequivalence diclofenac sodium sustained release tablets |
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