氟康唑片在中国汉族和回族健康志愿者体内的药动学研究

Study of pharmacokinetics of fluconazole tablets in Chinese healthy ethnic Han and Hui volunteers

目的：研究汉族和回族健康志愿者单剂量口服氟康唑片的药动学。方法：健康汉族和回族受试者各10名，男女各半，口服氟康唑片200mg，定时采血，用RP-HPLC法测定血药浓度，以DAS软件程序计算药动学参数。结果：汉族和回族受试者的主要药动学参数分别为Cmax（4．91±0．67）和（5．22±1．04）mg／L；tmax（1．90±0．90）和（2．20±1．30）h；t1/2（33．07±5．90）和（34．08±7．01）h；AUC0～96（189．61±32.91）和（197．21±49．35）mg·h·L^-1，AUC0-∞，（219．21±40．46）和（231．97±70．11）mg·h·L^-1。统计结果显示两民族受试者主要药动学参数无显著性差异。结论：汉族和回族受试者的氟康唑药动学无显著性差异。

Objective：To investigate the pharmacokinetics of fluconazole tablets after oral administration in Chinese healthy ethnic Han and Hui volunteers. Methods：Ten healthy volunteers each of Chinese ethnic Han and Hui （5 males and 5 females in each group） were orally given 200 mg fluconazole tablets. Blood samples were taken at predetermined time. The concentrations of fluconazole in plasma were determined by RP-HPLC method and pharmacokinetic parameters were calculated by DAS software. Results：The pharmacokinetic parameters of Han and H ui volunteers were as follows：Cmax （4. 91 ±0. 67） and （5. 22 ± 1.04） mg/L,tmax（1.90±0.90） and （2. 20±1.30） h,t1/2（33.07±5.90） and （34.08±7.01） h, AUC0-96 （189.61±32.91） and （197.21±49.35） mg·h·L^-1, AUC0-∞（219.21±40.46） and （231. 97±70.11） mg·h·L^-1,respectively.Statisticalanalysis showed no significant difference in main pharmacokinetic parameters of fluconazole between two ethnics. Conclusion：There is no significant difference in pharmacokinetics of fluconazole tablets between Chinese Han and Hui volunteers.