| HPLC-MS-MS法测定人血浆中苯磺酸氨氯地平的浓度及其药动学 |
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| 引用本文： | 张志锋,李婧,肖红涛,吴春蕾.HPLC-MS-MS法测定人血浆中苯磺酸氨氯地平的浓度及其药动学[J].西南民族学院学报(自然科学版),2009,35(4):776-780. |
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| 作者姓名： | 张志锋 李婧 肖红涛 吴春蕾 |
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| 作者单位： | 张志锋,李婧,吴春蕾,ZHANG Zhi-feng,LI Jing,WU Chun-lei(西南民族大学少数民族药物研究所,四川成都,610041);肖红涛,XIAO Hong-tao(四川省医学科学院·四川省人民医院药剂科,四川成都,610071) |
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| 摘 要： | 目的：建立人血浆中苯磺酸氨氯地平高效液相色谱-质谱联用测定法（HPLC-MS-MS），并研究苯磺酸氨氯地平在健康人体内的药动学行为，评价两片剂的生物等效性．方法：采用双交叉试验设计，血样用乙醚-二氯甲烷（2：1）混合液提取，HPLC-MS-MS分离测定，根据血药浓度．时间数据估算主要药动学参数和相对生物利用度，评价生物等效性．结果：苯磺酸氨氯地平的线性范围为0．1986～15．8880ng/mL．苯磺酸氨氯地平受试片和参比片的主要药动学参数分别是：Cmax为（5．9511±2．3623）和（5．5517±1．9781）ng/mL，Tmax分别为（5．89±2．25）和（5．83±1．54）h，AUC（04）分别为（195．6±79．4）和（212．7±72．1）ng/mL·h，AUC（0-∞）分别为（226．1±91．2）和（240．3±82．3）ng/mL·h．结论：本法简便、灵敏、准确，统计分析结果表明两片剂具有生物等效性．
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| 关 键 词： | 苯磺酸氨氯地平 高效液相色谱-质谱联用 药代动力学 |
Determination of amlodipine besylate in plasma and its pharmacokinetics by HPLC-MS-MS |
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| ZHANG Zhi-feng,LI Jing,XIAO Hong-tao,WU Chun-lei.Determination of amlodipine besylate in plasma and its pharmacokinetics by HPLC-MS-MS[J].Journal of Southwest Nationalities College(Natural Science Edition),2009,35(4):776-780. |
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| Authors: | ZHANG Zhi-feng LI Jing XIAO Hong-tao WU Chun-lei |
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| Institution: | ZHANG Zhi-feng, LI Jing, XIAO Hong-tao, WU Chun-lei(1.Ethnic Pharmaceutical Institute of Southwest University for Nationalities, Chengdu 610041, P.R.C.; 2. Department of Pharmacy, Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People＇s Hospital, Chengdu 610071, P.R.C.) |
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| Abstract: | Objective： To establish an HPLC-MS-MS method for determinating the concentration of amlodipine in human plasma, and to investigate the pharmacokineties and bioequivalence of two amlodipine besylate tablets in Chinese healthy volunteer. Method： Two-way crossover trial is performed. Plasma samples are extracted with ether-dichlormethane mixed liquor （2： 1） and determined by HPLC-MS-MS. The main pharmacokinetic parameters and relative bioavailability are estimated by plasma concentration-time data, and the bioequivalence is evaluated. Result： The parameters of amlodipine for test and reference formulations are as follows： Cmax, 5.9511 ± 2.3623 and 5.5517 ± 1.9781 ng/mL; Tmax, 5.89 ± 2.25 and 5.83 ± 1.54 h; AUC（0-t）, 195.6 ± 79.4 and 212.7 ± 72.1 ng/mL·h,AUC（0-∞）,226.1 ± 91.2 and 240.3 ± 82.3 ng/mL-h. Conclusion： HPLC-MS-MS method used in the study is sensitive, accurate and convenient. These 2 formulations ofamlodipine besylate are bioequivalent. |
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| Keywords: | amlodipine besylate HPLC-MS-MS bioequivalence |
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