中国汉族和朝鲜族健康志愿者单剂量口服氟康唑片的药物动力学考察

目的研究汉族和朝鲜族健康志愿者单剂量口服氟康唑片的药物动力学。方法健康汉族和朝鲜族受试者各10名,男女各半,口服氟康唑片200 mg,定时采血,用RP-HPLC法测定血药质量浓度,用drug and statistics(DAS 2.0.1)软件程序进行数据处理,用SPSS软件程序进行统计分析。结果汉族和朝鲜族受试者主要药物动力学参数ρmax为(4.91±0.67)、(4.70±0.86)mg.L-1;tmax为(1.90±0.90)、(2.55±1.07)h;t1/2为(33.07±5.90)、(31.02±6.02)h;AUC(0-96)为(189.61±32.91)、(183.75±31.83)mg.h.L-1,AUC(0-∞)为(219.21±40.46)、(209.93±46.37)mg.h.L-1。统计结果显示两民族受试者主要药物动力学参数差异无统计学意义。结论汉族、朝鲜族两民族的种族差异对氟康唑片的药物动力学无影响。

Pharmacokinetics of fluconazole tablets in Chinese healthy Han and Korean volunteers after a single dose oral administration

Abstract: Objective To investigate the pharmacokinetics of fluconazole tablets after oral administration in Chinese Han and Korean healthy volunteers. Methods Ten healthy volunteers of Chinese Han and Korean healthy volunteers (5 male and 5 female) were given 200 mg fluconazole tablets, and blood samples wereaken at predetermined times. The concentrations of fluconazole in plasmas were determined by RP-HPLC method and the pharmacokinetic parameters were calculated by drug and statistics software（DAS ver 2.0.1）. Results The pharmacokinetic parameters of 2 nations were as follows: ρmax were （4.91 ± 0.67），（4.70 ± 0.86）mg·L-1, tmax were (1.90±0.90), (2.55±1.07) h, t 1/2 were（33.07±5.90）, (31.02 ± 6.02)h, AUC(0-96) were（189.61±32.91）, (183.75±31.83)mg· h· L-1, AUC (0-∞) were (219.21 ± 40.46), (209.93 ± 46.37)mg ·h · L-1, respectively. The results of statistical analysis showed no significant difference in the main pharmacokinetics of fluconazole tablets between two races. Conclusion The ethnic difference between Chinese Han and Korean has no influence on the pharmacokinetics of fluconazole tablets.