进口盐酸托烷司琼胶囊在中国人体的药代动力学

目的　研究进口盐酸托烷司琼胶囊的人体药代动力学。方法　采用HPLC 二极管阵列紫外法测定 18名健康志愿者口服剂量为 10mg的盐酸托烷司琼胶囊后受试者血浆中的盐酸托烷司琼的浓度。并应用 3P97软件对盐酸托烷司琼的血药浓度 -时间数据进行了拟合 ,求算其药代动力学参数。结果　进口盐酸托烷司琼胶囊的药代动力学参数为 :达峰时间 (Tmax)为 (2 5 3± 0 5 2 )h ,峰值浓度 (Cmax)为 (10 16± 2 89) μg·L-1,曲线下面积AUC0～ 2 4h分别为 (113 6 1±4 0 34)h·μg-1·L-1。结论　进口盐酸托烷司琼胶囊在志愿者体内分布及消除都很快 ,10mg单次给药安全

Pharmacokinetic study of imported tropisetron chlorate capsule in human

Aim To study the pharmacokinetics of imported tropisetron chlorate capsule in human. Methods After oral administration of 10 mg imported tropisetron chlorate capsule, the blood concentration of tropisetron chlorate in eighteen male volunteers was determinated by HPLC-UV. And Concentration-time profile was simulated and pharmacokinetic parameters were calculated with 3P97 software. Results Pharmacokinetic parameters of tropisetron chlorate capsule were obtained as follows: T max was (2.53±0.52) h, C max was (10.16±2.89) μg·L -1, AUC 0～24 h was (113.61±40.34) h·μg -1·L -1. Conclusion Imported tropisetron chlorate distributes and eliminates rapidly in volunteers, it is safe after a single dose of 10mg administration.