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目的研究中国蒙古族、维吾尔族和回族健康志愿者单剂量口服莫达非尼片的药动学。方法 30名蒙古族、维吾尔族和回族健康受试者(每族10名,男女各半)单剂量口服莫达非尼片200 mg,采用HPLC-UV法测定血药浓度,用DAS 2.0软件计算各民族和不同性别中莫达非尼及其代谢物莫达非尼酸的药动学参数。结果蒙古族、维吾尔族和回族健康受试者莫达非尼的主要药动学参数:t1/2分别为(13±s 3)、(15±4)和(14±2)h,tmax分别为(2.2±0.8)、(1.8±0.5)和(1.9±0.9)h,ρmax分别为(4.9±0.7)、(4.8±0.7)和(4.7±1.0)mg.L-1,AUC0~∞分别为(69±12)、(71±16)和(71±20)mg.h.L-1;3个民族莫达非尼酸的主要药动学参数:t1/2分别为(5.2±1.2)、(7.2±0.7)和(7.1±1.8)h,tmax分别为(2.9±0.9)、(3.1±1.3)和(2.9±1.1)h,ρmax分别为(3.5±0.8)、(2.8±0.4)和(2.8±0.5)mg.L-1,AUC0~∞分别为(34±8),(34±6)和(34±4)mg.h.L-1,药动学参数没有民族间差异(P>0.05)。莫达非尼的ρmax[男性(4.3±0.5)vs.女性(5.3±0.7)mg.L-1,P<0.01]和Vd[男性(65±10)vs.女性(51±8)L,P<0.01],莫达非尼酸的tmax[男性(2.5±0.9)vs.女性(3.4±1.1)h,P<0.05]和ρmax[男性(2.8±0.5)vs.女性(3.3±0.7)mg.L-1,P<0.05]在男、女间有显著差异。结论口服莫达非尼片后蒙古族、维吾尔族和回族健康受试者间的药动学参数没有差异,而存在性别差异,提示不同性别用药时可能需要调整剂量。
Objective To study the pharmacokinetics of single dose oral modafinil tablets in Mongolian, Uygur and Hui healthy volunteers in China. Methods 30 Mongolian, Uygur and Hui healthy subjects (10 in each clan, half male and half female) were given 200 mg modafinil tablets orally. The blood concentration was measured by HPLC-UV and calculated by DAS 2.0 software Pharmacokinetic parameters of modafinil and its metabolites modafinil in different ethnic groups and genders. Results The main pharmacokinetic parameters of modafinil in Mongolian, Uygur and Hui healthy subjects were (13 ± s 3), (15 ± 4) and (14 ± 2) h, tmax respectively (4.9 ± 0.7), (4.8 ± 0.7) and (4.7 ± 1.0) mg.L-1 and (AUC0 ~ ∞) were (2.2 ± 0.8), (1.8 ± 0.5) and Were (69 ± 12), (71 ± 16) and (71 ± 20) mg.hL-1, respectively. The main pharmacokinetic parameters of modafinil in three ethnic groups were: t1 / 2 = 5.2 ± 1.2, (2.9 ± 0.9), (3.1 ± 1.3) and (2.9 ± 1.1) h, respectively. The values of ρmax were (3.5 ± 0.8), (2.8 ± 0.4) and (28 ± 6) and (34 ± 4) mg.hL-1, respectively, but there was no inter-ethnic difference between the two groups (P> 0.05). The mean ρmax for modafinil was 4.3 ± 0.5 vs 4.3 ± 0.7 mg.L-1 for women and 65 ± 10 for women and 51 ± 8 for women, P <0.01], tmax in menadine (2.5 ± 0.9) vs. Women (3.4 ± 1.1) h, P <0.05] and ρmax [male ± 2.8 ± 0.5 vs. mg.L-1, P <0.05] in men and women were significantly different. Conclusion There is no difference in pharmacokinetic parameters between Mongolian, Uygur and Hui healthy subjects after oral administration of modafinil tablets, but there is a gender difference, suggesting that dosage adjustment may be needed for different genders.