氟吡汀在蒙古族和汉族健康人体内的药代动力学

Pharmacokinetics of flupirtine maleate in Chinese Mongolian and Han healthy volunteers

目的研究中国蒙古族和汉族健康受试者口服马来酸氟吡汀(镇痛药)的药代动力学。方法 20名健康受试者(蒙古族和汉族各10名)男、女各半,单剂量口服马来酸氟吡汀胶囊100mg。用高效液相色谱法测定血浆中马来酸氟吡汀的浓度。结果口服马来酸氟吡汀后,蒙古族和汉族受试者的主要药代动力学参数:tmax分别为(1.40±0.46),(1.70±0.79)h;t1/2分别为(8.10±1.85),(8.85±2.15)h;Cmax分别为(1.24±0.31),(1.08±0.30)mg·L-1;AUC0-36分别为(9.57±2.23),(8.41±1.62)mg.h.L-1;AUC0-∞分别为(10.03±2.49),(8.97±2.00)mg.h.L-1。结论蒙古族和汉族健康受试者单剂量口服马来酸氟吡汀后,药代动力学参数的差异无统计学意义。

Objective To study the pharmacokinetics of flupirtine maleate capsule after a single oral dose in Chinese Mongolian and Han healthy volunteers. Methods Ten Chinese Mongolian and Ten Han healthy volunteers were given a single oral dose of 100 mg flupirtine maleate capsule. The plasma concentratin of flupirtine maleate was determined by HPLC. Results The main pharmacokinetic parameters Chinese Mongolian and Han healthy volunteers were as follows： tmax were （1 h, （9 （8 400.46）, （1.700.79） h, t1/2 were （8.10 1.85）, （8.85 2. 15） Cmax were （1.24 0.31）, （1.08 0.30） mg · L^-1, AUC0-36 were （9.57 2.23）, （8.41 1.62） mg h L^-1, AUC0-∞were （10. 03 ±2. 49）, 97 ± 2. 00） mg · h ·L^-1, respectively. Conclusion There were no significant difference in the pharmaeokinetic parameters between Mongolian and Han healthy volunteers.