关键词: 坎地沙坦, 药动学, 色谱法, 高效液相, 坎地沙坦酯

Abstract: AIM: To establish a HPLC method for determination of concentration of candesartan in human plasma and study the pharmacokinetics of the tested tablet in Chinese healthy volunteers. METHODS: 20 healthy volunteers received tested tablet (a single oral dose of candesartan cilexetic 16 and 32mg and multidose 16 mg, qd × 6 d).Candesartan concentrations in plasma were determined by HPLC. RESULTS: The main pharmacokinetic parameters of candesartan were as follows:t 1 2β were 6.6± 0.5 h, 6.8± 0.4 h and 6.6± 0.5 h;t_max were 4.1± 0.6 h, 4.5± 0.5 h, 4.4± 0.4 h;C_max were 152± 23 μg/L, 226± 39 μg/L and 166± 25 μg/L;AUC_0-36 were 1145± 478, 2416± 398 and 1282± 423 μg·h·L ^-1;MRT0-36 were 10.3± 0.5 h, 10.8± 0.7 h, 10.7± 0.3 h. CONCLUSION: The method is accurate, sensitive and reliable, and a two-compartment open pharmacokinetic model is adapted in candesartan plasma concentration-time data analysis;The main pharmacokinetic parameters of the domestic candesartan are similar to those reported abroad, so it can be extensively used in clinic.

Key words: candesartan, pharmacokinetics, chromatography, HPLC, candesartan cilexetic