摘要
目的研究在进食和空腹状态下中国健康受试者口服替米沙坦片的药动学差异。方法采用随机交叉给药方案,10名健康受试者进食或空腹单剂量口服替米沙坦片80mg,用高效液相色谱-荧光检测法测定血浆中替米沙坦的浓度,用DAS2.0软件计算其主要药动学参数。结果10名健康受试者在进食和空腹状态下单次口服替米沙坦片80mg的主要药动学参数ρmax分别为(455±s192)和(1186±1007)μg·L-1;tmax分别为(2.6±1.1)和(1.5±1.1)h;t1/2分别为(20±6)和(17±6)h;AUC0～t分别为(3503±1660)和(4895±2444)μg·h·L-1。进食状态下的ρmax和AUC0～t分别为空腹状态的(53±31)%和(73±20)%,tmax也明显延后。结论进食影响替米沙坦片的吸收速度和程度。
AIM To study the differences of pharmacokinetics of telmisartan tablet between administered with food and in fasted state in healthy Chinese volunteers. METHODS Ten healthy volunteers were given telmisartan tablet 80 mg administered with food or in fasted state by a random crossover study design, the concentration of telmisartan in human plasma was determined by HPLC with fluorescent detection （HPLC-FLD）. The main pharmacokinetic parameters were calculated with DAS 2.0 software. RESULTS The main pharmacokinetic parameters of telmisartan when healthy volunteers administered with food or in fasted state were as follows： pmax were （455 ±s 192） and （1 186±1 007） μg·L^-1, tmax were （2.6±1.1） and （1.5 ±1.1） h, t1/2 were （20 ±6） and （17 ±6） h, AUC0-t were （3 503 ±1 660） and （4 895 ±2 444） μg·L^-1, respectively. pmax and AUCo, of telmisartan administered with food were （53 ± 31）% and （73 ±20）% of that in fasted state, respectively, and tmax was prolonged too. CONCLUSION Food affect the absorption rate and exposure of telmisartan.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2009年第6期439-441,共3页
Chinese Journal of New Drugs and Clinical Remedies
关键词
替米沙坦
药动学
食品药物相互作用
色谱法
高压液相
光谱法
荧光
telmisartan
pharmacokinetics
food-drug interactions
chromatography, high pressure liquid
spectrometry, fluorescence
