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目的研究盐酸度洛西汀肠溶胶囊的药动学,为该药的临床应用提供依据。方法分单剂量组和多剂量组进行试验。单剂量组分周期交叉口服高、中、低剂量受试药物,多剂量组按临床常规剂量连续给药7d。采用HPLC-MS测定血浆中度洛西汀的浓度,用DAS2.0对血药浓度-时间数据进行药动学模型拟合和参数计算。结果体内药动学符合一室模型特征。主要药动学参数ρmax,AUC0-72,AUC0-∞与剂量相关,tmax,t1/2则与剂量无关。连续口服盐酸度洛西汀肠溶胶囊,4d后血药浓度达到稳态。除单剂量组口服44.8mg时的Ka值外,主要药动学参数性别间均没有差异。结论盐酸度洛西汀在健康人体内符合线性药动学特征,主要药动学参数没有性别差异。
Objective To study the pharmacokinetics of duloxetine hydrochloride enteric-coated capsules and provide the basis for its clinical application. Methods Divided single dose group and multiple dose group. Single-dose components of the cycle of oral administration of high, medium and low doses of the test drug, multi-dose group according to conventional clinical dose of continuous administration of 7d. The concentration of duloxetine in plasma was determined by HPLC-MS, and the pharmacokinetic model fitting and parameter calculation of plasma concentration-time data were performed by DAS2.0. Results In vivo pharmacokinetics fit the one-compartment model features. The main pharmacokinetic parameters ρmax, AUC0-72, AUC0-∞ and dose-related, tmax, t1 / 2 dose-related. Continuous oral duloxetine hydrochloride enteric-coated capsules, 4d plasma concentration reached steady state. Except for the Ka value of 44.8 mg given in single-dose group, there was no difference in the main pharmacokinetic parameters between sexes. Conclusion Duloxetine hydrochloride has a linear pharmacokinetic profile in healthy volunteers. There are no gender differences in the main pharmacokinetic parameters.