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目的:建立测定阿立哌唑血浆药物浓度的HPLC-UV检测法,研究国产阿立哌唑片在人体的药代动力学。方法:14名健康志愿受试者多剂量口服国产阿立哌唑片20mg,采用HPLC法测定给药后不同时间点血浆中阿立哌唑浓度,用DAS1.0处理经时血药浓度数据,计算主要药代动力学参数。结果:多次口服阿立哌唑片共14 d达稳态,稳态血药浓度期间给药后(4.0±0.9)h达到峰浓度(480.3±126.2)μg.L-1,AUC0-360 h为(38166.6±13241.2)μg.h.L-1,t1/2β为(91.0±21.1)h,CL/F和V/F分别为(0.62±0.36)L.h-1和(60.9±43.7)L。结论:国产阿立哌唑的血药浓度一时间曲线符合二室开放模型,为今后的合理用药打下基础。
OBJECTIVE: To establish a HPLC-UV method for the determination of plasma drug concentration of aripiprazole and to study the pharmacokinetics of domestic aripiprazole tablet in human. Methods: A total of 14 healthy volunteers were orally given 20 mg domestic aripiprazole. The plasma concentrations of aripiprazole at different time points were determined by HPLC. Calculate the main pharmacokinetic parameters. Results: The aripiprazole tablets were orally administrated for 14 days to a steady state. Peak plasma concentrations (480.3 ± 126.2) μg.L-1 and AUC0-360 h (91.0 ± 21.1) h and (0.62 ± 0.36) Lh-1 and (60.9 ± 43.7) L for (38166.6 ± 13241.2) μg.hL-1, respectively. Conclusion: The time curve of plasma concentration of domestic aripiprazole conforms to the two-compartment open model, laying a foundation for rational drug use in the future.