阿比朵尔胶囊在中国汉族和藏族健康人体的药动学研究

Study on Pharmacokinetics of Arbidol Capsules in Chinese Han and Tibetan Healthy Volunteers

目的研究汉族和藏族健康志愿者单剂量口服阿比朵尔胶囊的药动学。方法健康志愿者20名(其中汉族、藏族各10名,男女各半),单剂量口服阿比朵尔胶囊200 mg,采用HPLC法测定血浆中阿比朵尔的含量。采用DAS2.1软件程序进行数据处理,并用SPSS统计学软件进行分析。结果受试者单剂量口服阿比朵尔胶囊200 mg后,汉族健康志愿者主要药动学参数为:Cmax为(783.83±164.29)ng/ml,tmax为(1.31±0.62)h,t1/2为(10.39±2.84)h,AUC0-48为(6372.2±1139.4)ng.h/ml;AUC0-∞为(6831.3±1341.2)ng.h/ml。藏族健康志愿者主要药动学参数为:Cmax为(752.2±137.5)ng/ml,tmax为(1.66±0.64)h,t1/2为(10.71±4.35)h,AUC0-48为(6488.5±1293.7)ng.h/ml;AUC0-∞为(7018.4±1621.8)ng.h/ml。结论健康志愿者单剂量口服阿比朵尔胶囊的体内药动学过程符合一室模型。经统计学分析,汉族和藏族健康志愿者药动学过程不存在种族、性别差异。

Objective To study the pharmaeokinetics of arbidol capsules after a single oral dose in Han and Tibetan healthy volunteers. Methods Ten Han healthy volunteers and ten Tibetan healthy volunteers were involved in the study. Each subject received a single dose of 200 mg arbidol capsules. The plasma concentration was deter- mined by HPLC. The pharmacokinetic parameters were calculated by DAS software and were statistically analyzed by SPSS software. Results The main pharmacokinetic parameters of Han nationality subjects were as follows： C max was （783.83 _± 164.29）ng/ml, t max WaS （1.31 ±0.62） h, t 1/2 was （10.39 ±2.84） h, AUC0-48 was （6372.2 ± 1139.4） ng .h/ml ; AUC0-∞ was （6831.3 ± 1341.2） ng .h/ml. Those of Tibetan subjects were as follows ： C ma, was （752.2 ± 137.53 ） ng/ml, tmax was （ 1.66 ± 0.64） h, t 1/2 was （ 10.71 ± 4.35 ） h, AUC0-48 was （6488.5 ± 1293.7 ） ng .h/ml;AUC0-∞ was （7018.4 ± 1621.8 ）ng-h/ml. Conclusion The plasma concentration-time curve of arbidol fits with an one-compartment model and the main pharmaeokinetie parameters of arbidol are not significantly differ- ent between Han and Tibetan volunteers of both genders.