盐酸托烷司琼胶囊的人体药代动力学研究

目的: 研究盐酸托烷司琼胶囊的人体药代动力学。方法: 采用高效液相色谱(HPLC)-二极管阵列紫外法测定18 名健康志愿者口服剂量10 mg 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-时间数据进行拟合, 求其药代动力学参数。结果: 盐酸托烷司琼胶囊的药代动力学参数为:达峰时间(Tmax ) 2. 33±0. 43 h, 峰值浓度(Cmax ) 10. 48±2. 70 μg·L^-1, 曲线下面积(AUC0-24 h ) 111. 89±39. 86 μg·h^-1·L^-1 。结论: 盐酸托烷司琼胶囊在志愿者体内分布及消除都很快, 10 mg 单次给药安全。

Pharmacokinetic study of tropisetron chlorate capsule in healthy volunteers

AIM: To study the pharmacokinetics of tropisetron chlorate capsule in healthy volunteers.METHODS: After the oral administration of 10mg tropisetron chlorate capsule, the blood concentrations of tropisetron chlorate in eighteen male volunteers were measured by HPLC-UV. Concentrations-time profiles were simulated and pharmacokinetic parameters were calculated with 3P97 software.RESULTS: Pharmacokinetic parameters of tropisetron chlorate capsule were obtained as follows: T_max was 2. 33±0. 43 h, C_max was 10. 48±2. 70 μg·L^-1, and AUC_{0-24 h} was 111. 89±39. 86 h·μg·L^-1.CONCLUSION: A single dose administration of 10 mg tropisetron chlorate can distribute and eliminate quickly, which is safety in volunteers.