Chang Xin-Yu, Guo Tao, Xia Dong-Ya
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, China.
J Pharm Pharm Sci. 2009;12(2):175-80. doi: 10.18433/j3kk50.
This study investigated the pharmacokinetics of tinidazole in subjects of five different Chinese nationalities (Han, Mongolian, Korean, Hui, and Uighur).
Fifty healthy subjects (five male and five female of each nationality) were recruited for the study, and each received 1 g tinidazole. A total of 14 blood samples were collected over a 72-hour period after administration.
Pharmacokinetic profiles, including area under the curve from time zero to infinity (AUC0-inf), peak plasma concentration (Cmax), time to reach Cmax (tmax), oral clearance (CL/F), elimination rate constant (Ke), and elimination half-life (t1/2), were determined following a single oral dose of tinidazole. The respective pharmacokinetic properties of Han, Mongolian, Korean, Hui, and Uighur nationalities were: half-life (h): 16.94+/-2.40, 16.40+/-1.79, 16.63+/-1.82, 16.81+/-1.56, 14.34+/-1.92; Cmax (microg/mL): 19.04+/-2.42, 19.22+/-4.93, 20.83+/-3.33, 20.25+/-4.05, 18.81+/-3.10; AUC0-inf (h*microg/mL): 483.13+/-65.65, 479.70+/-99.74, 511.07+/-53.47, 514.25+/-130.78, 388.58+/-37.37. The t1/2 and AUC0-inf of Uighur subjects were significantly lower (p =0.023, 0.011) and the CL/F and Ke were significantly higher (p = 0.003, 0.013) than those of other nationalities. After normalization by weight, the differences in AUC0-inf and CL/F between Uigur subjects and those of other races were still significant.
The results indicate that ethnicity had significant impact on the pharmacokinetics of tinidazole after a single oral dose in healthy volunteers of different nationalities in China.
本研究调查了替硝唑在五个不同中国民族(汉族、蒙古族、朝鲜族、回族和维吾尔族)受试者中的药代动力学。
招募50名健康受试者(每个民族5名男性和5名女性)参与研究,每人服用1克替硝唑。给药后72小时内共采集14份血样。
单次口服替硝唑后,测定了药代动力学参数,包括从零到无穷大的曲线下面积(AUC0-inf)、血浆峰浓度(Cmax)、达到Cmax的时间(tmax)、口服清除率(CL/F)、消除速率常数(Ke)和消除半衰期(t1/2)。汉族、蒙古族、朝鲜族、回族和维吾尔族各自的药代动力学特性如下:半衰期(小时):16.94±2.40、16.40±1.79、16.63±1.82、16.81±1.56、14.34±1.92;Cmax(微克/毫升):19.04±2.42、19.22±4.93、20.83±3.33、20.25±4.05、18.81±3.10;AUC0-inf(小时·微克/毫升):483.13±65.65、479.70±99.74、511.07±53.47、514.25±130.78、388.58±37.37。维吾尔族受试者的t1/2和AUC0-inf显著低于其他民族(p = 0.023,0.011),CL/F和Ke显著高于其他民族(p = 0.003,0.013)。按体重归一化后,维吾尔族受试者与其他种族受试者之间的AUC0-inf和CL/F差异仍然显著。
结果表明,在中国不同民族的健康志愿者中,种族对单次口服替硝唑后的药代动力学有显著影响。