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目的研究中国汉族和回族健康志愿者单剂量口服酒石酸唑吡坦片的药代动力学。方法招募汉族、回族健康志愿者各10名,男女各半;单剂量口服酒石酸唑吡坦片10 mg后,采用高效液相色谱法测定血浆中酒石酸唑吡坦的含量,测得数据采用DAS 2.0软件进行处理,并用SPSS统计学软件进行分析。结果回族、汉族健康受试者单剂量口服10 mg酒石酸唑吡坦片后的主要药动学参数为:t1/2分别为(2.84±0.80)、(2.21±0.77)h,tmax分别为(0.75±0.18)、(0.93±0.47)h,Cmax分别为(199.64±55.48)、(190.81±70.59)μg/L,AUC0-12分别为(742.11±234.34)、(624.48±192.15)μg.h/L,AUC0-∞分别为(803.94±272.08)、(649.58±210.17)μg.h/L。结论经统计学分析,酒石酸唑吡坦在回族和汉族健康志愿者体内的药代动力学过程不存在显著种族差异。
Objective To study the pharmacokinetics of a single oral dose of zolpidem tartrate tablets in Chinese Han and Hui healthy volunteers. Methods 10 Han and Hui healthy volunteers were enrolled in this study. Male and female were enrolled in this study. The content of zolpidem tartrate in plasma was determined by high performance liquid chromatography after a single oral dose of 10 mg zolpidem tartrate tablets was measured by DAS 2.0 Software was processed and analyzed using SPSS statistical software. Results The main pharmacokinetic parameters of 10 mg zolpidem tartrate tablets were (2.84 ± 0.80) and (2.21 ± 0.77) h respectively in healthy subjects of Hui and Han nationality, the tmax were (0.75 ± 0.18), (0.93 ± 0.47) h and Cmax were (199.64 ± 55.48) and (190.81 ± 70.59) μg / L respectively, and AUC0-12 were (742.11 ± 234.34) and (624.48 ± 192.15) μg.h / L , AUC0-∞ were (803.94 ± 272.08), (649.58 ± 210.17) μg.h / L, respectively. Conclusion According to statistical analysis, there is no significant ethnic difference in the pharmacokinetics of zolpidem tartrate in Hui and Han healthy volunteers.