马来酸氟吡汀在汉族健康人体内的药动学研究

Pharmacokinetics of Flupirtine maleate in Chinese Han Nationality Healthy Volunteers

目的研究马来酸氟吡汀在中国汉族健康人体的药动学。方法选择10名汉族健康受试,口服马来酸氟吡汀胶囊100mg。用高效液相色谱法测定给药后不同时间点的马来酸氟吡汀的血浆浓度,用3P97程序估算药动学参数。结果口服马来酸氟吡汀胶囊100 mg后,氟吡汀的药-时曲线符合一级吸收二室模型,主要药动学参数为:tmax(1.70±0.79)h,ρmax(1 078.1±296.7)μg.L-1,t1/2α(1.46±0.51)h,t1/2β(9.37±2.57)h,AUC0-∞(8 971.7±1 996.5)μg.h.L-1。结论健康受试者单剂量口服马来酸氟吡汀胶囊的药动学参数与文献报道基本一致。

OBJECTIVE To investigate the pharmacokinetics of flupirtine maleate in Chinese Han nationality healthy volunteers. METHODS 10 Healthy volunteers were given with a single oral dose （ 100 mg） of flupirtine maleate capsule. Blood samples were collected from vein at certain sampling times. Flupirtine maleate in plasma were determined by HPLC fluorescence method, and the pharmacokinetic parameters were calculated by 3P97 software. RESULTS The plasma concentration-time curves of flupirtine were discribed by a two-compartment model with first order absorption. The main pharmacokinetic parameters were as follows ： tmax （ 1. 70 ± 0. 79） h, pmax （ 1 078. 1 ± 296. 7） ug . L-1, t1/2a （ 1.46 ± 0. 51 ） h, t1/2β （9. 37± 2.57 ） h and AUC0-∞ （ 8 971.7± 1 996. 5 ） ug. h. L - 1. CONCLUSION The pharmacokinetic parameters of flupirtine maleate in healthy volunteers after an oral single dose of flupirtine maleate capsule is concordant with that of the literature.