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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。
Objective To study the pharmacokinetics of oral telmisartan tablets in Chinese healthy subjects under fasting and fasting conditions. Methods A randomized crossover study was conducted in which 10 healthy volunteers were given oral or single oral dose of telmisartan 80 mg, and plasma concentrations of telmisartan were determined by high performance liquid chromatography-fluorescence detection with DAS 2.0 The software calculates its main pharmacokinetic parameters. Results The main pharmacokinetic parameters ρmax were (455 ± s192) and (1186 ± 1007) μg · L-1, respectively, for 10 mg of telmisartan tablets in fed and fasting state of 10 healthy subjects; tmax Were (2.6 ± 1.1) and (1.5 ± 1.1) h; t1 / 2 were (20 ± 6) and (17 ± 6) h, respectively; AUC0 ~ t were (3503 ± 1660) and (4895 ± 2444) μg · h · L-1. The ρmax and AUC0 ~ t of fed state were (53 ± 31)% and (73 ± 20)% of fasting state respectively, and tmax was also significantly delayed. Conclusion The feeding affects the speed and extent of telmisartan absorption.