摘要
目的:评价曲美他嗪胶囊与参比制剂(曲美他嗪片)是否生物等效。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HPLC-ESI-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_(max)分别为(2.1±s0.6)和(2.1±0.6)h, c_(max)分别为(49±9)和(48±9)μg·L^(-1),t_(1/2)分别为(6.2±1.4)和(6.1±1.3)h,Ke分别为(0.117±0.022)和(0.118±0.023)h^(-1),用梯形法计算VUC_(0~24)分别为(424±86)和(430±102)μg·h·L^(-1)。2种制剂的主要药动学参数c_(max),AUC_(0~24)经对数转换后进行方差分析及双单侧t检验,并计算90%置信区间,表明2种制剂生物等效,相对生物利用度为(101±17)%。结论:曲美他嗪胶囊与片剂生物等效。
AIM: To evaluate the bioequivalence of trimetazidine capsule and tablet. METHODS: A
20 mg dose of the reference or test drug was given to each of the 18 healthy male volunteers in a randomized two-way crossover design and the plasma concentration of the drug was assayed by HPLC-MS. The main pharmacokinetic parameters and bioequivalence of the two formulations were evaluated.RESULTS : The tmax,cmax, tl/2, Ke and AUC0-24 of the test and reference drugs were (2.1± s 0.6) and (2.1±0.6) h, (49±9) and (48±9)μg·L^-1, (6.2±1.4) and (6.1±1.3)h,
(0.177±0.022) and (0.118±0.023) h^-1,(424±86) and (430±102)μg·h·L^-1,respectively. The relative bioavailability of the test product to the reference was (101±17)%. 1CONCLUSION: The trimetazidine capsule and tablet are bioequivalent.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2007年第6期419-422,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
曲美他嗪
色谱法
高压液相
光谱法
质量
电喷雾电离
生物等效性
trimetazidine
chromatography, high pressure liquid
spectrometry, mass, electrosprayionization
bioequivalence