摘要
目的:建立LC-MS方法测定盐酸曲美他嗪在健康人血浆中的浓度,并进行药物动力学研究和生物等效性评价。方法:18名男性健康受试者,随机分成2组,交叉口服受试制剂和参比制剂各20 mg,采用LC-MS法测定人血浆中曲美他嗪的浓度。结果:受试制剂与参比制剂的各主要药动学参数:t_(1/2)分别为(7.31±2.36)和(6.74±2.17)h,t_(max)分别为(2.1±0.9)和(1.8±0.6)h,C_(max)分别为(92.05±19.64)和(96.71±22.31)ng·ml^(-1),AUC_(0-24)分别为(691.24±171.82)和(706.31±189.60) ng·h·ml^(-1)。对两种制剂的参数C_(max)、AUC_(0-24)对数转换后先进行方差分析,再进行双单侧t检验。双单侧t检验结果表明上述两个参数生物等效,t_(max)经非参数法检验差异没有显著性意义(P>0.05),这表明两种制剂生物等效,相对生物利用度(101.5±26.7)%。结论:两种制剂具有生物等效。
Objective:To develop a method for the determination of trimetazidine in human plasma by liquid chromatography-electrospray ionisation-mass spectrometry(LC-ESI-MS),and evaluation the pharmacokinetics and bioequivalence of trimetazidine dihydrochloride tablet.Method:Randomized two-way crossover study was used,each of the 18 healthy male volunteers was given a single oral dose of 20 mg trimetazidine dihydrochloride tablet.The concentration of trimetazidine in plasma was determined by LC-ESI-MS.The main pharmac...
出处
《中国药师》
CAS
2009年第2期156-159,共4页
China Pharmacist
