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目的:考察中国人口服艾普拉的群体药动学特征。方法:70例胃溃疡或反流患者口服艾普拉唑肠溶片后,静脉采血,以液-质联用(LC-MS/MS)法测定艾普拉唑血浆浓度,用非线性混合效应模型(NONMEM)程序分析中国人艾普拉唑群体药动学特征。结果:成功建立了威布尔函数模型并获得相应的群体药动学模型参数,表观清除率(CL/F)为2.74 L/h,表观分布容积(V/F)为12.6 L,吸收速率常数(Ka)为0.361,形状因子(Gama)为2.19,性别对CL/F的影响(GEN CL)为0.881。结论:本试验所建立的模型拟合度高。性别对CL/F的影响显著;体质量、身高、丙氨酸氨基转移酶、天冬氨酸氨基转移酶、血清肌酐及基础疾病(溃疡和反流)均不影响艾普拉唑在目标适应证受试者体内的药动学行为。
Objective: To investigate the population pharmacokinetic characteristics of Chinese population oral Epra. Methods: Seventy patients with gastric ulcer or reflux were treated with ioprazole enteric-coated tablets, and blood was collected by venous blood. The plasma concentration of ilaprazole was determined by liquid chromatography-mass spectrometry (LC-MS / MS) Model (NONMEM) program to analyze the pharmacokinetics of Ipsoprazole in Chinese population. Results: The Weibull function model was successfully established and the parameters of the population pharmacokinetic model were obtained. The apparent clearance (CL / F) was 2.74 L / h, the apparent volume of distribution (V / F) The constant (Ka) was 0.361, the shape factor (Gama) was 2.19, and the genotoxic effect on CL / F (GEN CL) was 0.881. Conclusion: The model established in this study has a high degree of fitness. Gender had a significant effect on CL / F; body weight, height, alanine aminotransferase, aspartate aminotransferase, serum creatinine and underlying disease (ulceration and reflux) did not affect ilaprazole in target adaptation Subject pharmacokinetic behavior in the test subjects.