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LC-MS法评价两种苯磺酸氨氯地平片的人体生物等效性
梁超[1]程晓华[2]张红[2]徐文炜[2]胡晓[2]
0
([1]江西省人民医院普通外科,南昌333000 [2]南昌大学医学院临床药理研究所,南昌330006)
摘要:
目的:建立LC-MS法测定人体血浆中苯磺酸氨氯地平的药物浓度,并进行两种制剂的生物等效性评价。方法:20例健康受试者单剂量交叉口服10 mg苯磺酸氨氯地平供试制剂或参比制剂后,采用LC-MS测定人体血浆中不同时间点苯磺酸氨氯地平的浓度,计算其药代动力学参数和相对生物利用度,评价两制剂的生物等效性。结果:苯磺酸氨氯地平供试制剂和参比制剂主要药代动力学参数如下:Cmax分别为(6.21±1.88)(、6.03±1.08)ng/ml,AUC0-120分别为(250.68±52.61)、(246.14±52.11)ng·h/ml,Tmax分别为(6.0±2.3)、(6.1±2.5)h,t1/2分别为(40.45±6.68)、(43.74±9.05)h。本方法在0.1-20.0 ng/ml浓度范围内线性关系良好。最低可定量浓度为0.1 ng/ml,两制剂主要药动学参数经统计学检验无显著性差异。结论:本方法简单、快速、准确,两种制剂具有生物等效性。[
关键词:  氨氯地平 苯磺酸盐类 色谱法,高压液相 光谱分析,质量 药代动力学 生物
DOI:10.3724/SP.J.1008.2007.00299
基金项目:
Liquid chromatography-mass spectrometry in evaluation of bioequivalence of two kinds of amlodipine besylate tablets
LIANG Chao , CHENG Xiao-hua , ZHANG Hong , XU Wen-wei , HU Xiao
(1. Department of General Surgery, The People's Hospital of Jiangxi Province, Nanchang 330006, China; 2. Institute of Clinical Pharmacology, Medical School, Nanchang University, Nanchang 330006)
Abstract:
Objective: To establish a liquid chromatography-mass spectrometry (LC-MS) method for determining the concentration of amlodipine besylate in human plasma and to evaluate the bioequivalence of 2 kinds of amlodipine besylate tablets. Methods: Twenty healthy male volunteers were enrolled into a single crossover study. A single dose of the suspension equivalent to 10 mg amlodipine besylate or a reference preparation was given in a crossover way. The plasma concentrations of amlodipine besylate were determined by LC-MS method in the volunteers at different time points; the pharmacokinetic parameters and relative bioavailability were calculated and the bioequivalence of the 2 preparations were evaluated. Results: The pharrnacokinetic parameters for experimental and the reference preparations were: Cmax (6. 21 ± 1. 88) vs( 6. 03 ± 1. 08) ng/ml; AUC0-120(250. 68±52. 61) vs (246.14±52.11) ng h/ml; Tmax(6.0±2.3) vs (6. 1± 2.5) h; t1/2(40.45±6.68) vs (43.74±9.05) h, respectively. The linear range of the present method was 0. 1-20. 0 ng/ml; the lowest detectable concentration of amlodipine besylate was 0.1 ng/ml. There was no significant difference in pharmacokinetic parameters between the 2 tablets. Conclusion: The present method is simple to use, fast, and accurate. The 2 preparations of amlodipine besylate are bioequivalent.[
Key words:  amlodipine  benzenesulfonates  chromatography, high pressure liquid  spectrum analysis, mass  pharmacokinetics  biological availability