Guo Tao, Mao Guifu, Zhao Longshan, Xia Dongya, Yang Lu
Department of Pharmacy, Shenyang Northern Hospital, Shenyang 110840, China.
Department of Pharmacy, Women and Children Health Hospital of Liuzhou, Liuzhou 545001, China.
Acta Pharm Sin B. 2014 Apr;4(2):146-50. doi: 10.1016/j.apsb.2014.02.001. Epub 2014 Mar 15.
The objective of this study was to evaluate the difference in the pharmacokinetics of zolpidem tatrate in subjects from five Chinese ethnicities (Han, Mongolian, Uigur, Korean and Hui). Healthy subjects (10 Hans, 10 Mongolians, 10 Uigurs, 10 Koreans and 9 Huis) were recruited and each received a 10 mg tablet-dose of zolpidem tatrate. A total of 12 plasma samples were collected over a 12 h period after administration. The concentrations of zolpidem in plasma were determined by an HPLC-FLU method, after which the pharmacokinetic parameters were determined using DAS 2.0 software and analyzed by SPSS 16.0 software. After normalization by weight, no differences were noted in the pharmacokinetic parameters of zolpidem tatrate among the five ethnic groups (P>0.05). However, there were statistically significant differences between males and females for the pharmacokinetic parameters (P<0.05). The metabolism of zolpidem tatrate in males was faster than in females. Results indicate that ethnicity has no significant impact on the pharmacokinetics of zolpidem tatrate after a single oral dose in healthy Chinese subjects. However, an effect of gender on the pharmacokinetics of zolpidem tatrate can be noted.
本研究的目的是评估酒石酸唑吡坦在五个中国民族(汉族、蒙古族、维吾尔族、朝鲜族和回族)受试者中的药代动力学差异。招募了健康受试者(10名汉族、10名蒙古族、10名维吾尔族、10名朝鲜族和9名回族),每人服用10毫克酒石酸唑吡坦片剂剂量。给药后12小时内共采集12份血浆样本。采用高效液相色谱-荧光法测定血浆中唑吡坦的浓度,然后使用DAS 2.0软件测定药代动力学参数,并通过SPSS 16.0软件进行分析。按体重归一化后,五个民族之间酒石酸唑吡坦的药代动力学参数无差异(P>0.05)。然而,药代动力学参数在男性和女性之间存在统计学显著差异(P<0.05)。男性中酒石酸唑吡坦的代谢比女性快。结果表明,在健康中国受试者中,单次口服给药后,民族对酒石酸唑吡坦的药代动力学没有显著影响。然而,可以注意到性别对酒石酸唑吡坦药代动力学的影响。