盐酸托烷司琼胶囊的人体药代动力学研究

Pharmacokinetic study of tropisetron chlorate capsule in healthy volunteers

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 10mg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 .4 3h ,峰值浓度 (Cmax) 10 .4 8±2 .70 μg·L-1,曲线下面积 (AUC0 -2 4h) 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 ,10mg单次给药安全。

AIM: To study the pharmacokinetics of tropisetron chlorate capsule in healthy volunteers. METHODS: After the oral administration of 10 mg 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.