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曲美他嗪胶囊的人体生物等效性评价 被引量:2

Study on bioequivalence of trimetazidine capsule and tablet in healthy volunteers
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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
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