关键词: 双环醇, 药代动力学, 高效液相色谱

Abstract: Aim To observe the pharmacokinetic profiles of oral administration of bicyclol in 30 healthy volunteers. Methods Thirty healthy volunteers were randomized into 25 mg, 50 mg and 100 mg groups.They were given bicyclol in a single dosage or multiple dosages before and after meal respectively.The plasma concentration of bicyclol was assayed by the high performance liquid chromatograply (HPLC).The pharmacokinetic parameters were analysed by 3p97 softwere. Results The feature of pharmacokinetics conformed to one compartment model and a first order elimination. For the three dose groups of 25, 50 and 100 mg, the values of t_(1/2)ka were (0.84±0.68)、 (0.33±0.09)and (1.19±10.9)h, respectively; the values of t_(1/2)ke were (6.26±6.24), (6.17±2.01) and (4.66±1.21)h, respectively;V_d/F (455.02±135.35), (622.94±325.37) and (688.83±308.14)L;CL/F (93.45±67.66)、 (83.31±71.97)、(104.30±45.76)h.Between single dose and mult iple dosages, the pharmacokinetic parameters had no significant difference, showing there was no accumulation in the body.Before and after meal, the values of c_max were (151.26±39.00) and (222.64±43.22)μg·L^-1, respectively (P<0.01), but the AUC_0～∞ had no significant difference,which was probabily related to the lipo troph of bicyclol.Conclusion Bicyclol has alinear pharmacokinetic feature.The absorption of bicyclol is influenced by food.

Key words: bicyclol, pharmacokinetic, high performance liquid chromatog raphy