目的 研究鹽酸吡硫醇脂質(zhì)體注射液在大鼠體內(nèi)的藥動學行為，并與鹽酸吡硫醇注射液進行比較，評價鹽酸吡硫醇脂質(zhì)體藥動學特征。方法 采用大鼠股靜脈給藥，眼眶取血，UPLC/MS/MS法測定大鼠血漿中鹽酸吡硫醇的濃度，運用MasslynxTM NT4.1軟件進行數(shù)據(jù)采集；運用QuanLynxTM program進行數(shù)據(jù)分析。結(jié)果 脂質(zhì)體及溶液劑的AUC0-t分別為（1817.093±197.832）、（2592.349±303.194）μg/(L?h)；Cmax分別為（6080.502±549.12）、（9525.987±531.813）μg/L；t1/2分別（1.512±0.387）、（0.732±0.388）h。兩制劑的藥時過程均符合三隔室模型，兩者藥動學行為相似。結(jié)論 運用DAS2.0進行生物等效性評價，脂質(zhì)體組與溶液劑組藥動學參數(shù)均在等效置信區(qū)間內(nèi)，兩制劑生物等效。

Objective To study on the pharmacokinetic behavior in vivo of pyritinol hydrochloride（Py-Hy）liposomes injection in rats and compare with the Py-Hy solution to evaluate pharmacokinetic characteristics of the Py-Hy liposomes. Methods Using femoral vein of rats, taking eyes blood, using UPLC/MS/MS to determinate plasma concentration of pyritinol hydrochloride in rat, using Masslynx TM NT4.1 software for data collection. Using Quan LynxTM program for data analysis. Results AUC0-t of liposomes and solution agent are (1817.093 ± 197.832) and (2592.349 ± 303.194) μg/(L?h), Cmax were (6 080.502 ± 549.12) and (9 525.987 ± 531.813) μg/L, t1/2 were (1.512 ± 0.387) and (0.732 ± 0.388) h, respectively. The medicine processes of the two preparations was in line with the three compartment model, and the pharmacokinetic behavior of the two preparations was similar. Conclusion The bioequivalence is evaluated by DAS2.0, the pharmacokinetic parameters of liposomes and solution agent group is in equivalent within the confidence interval, and the two preparations is biological equivalent.