[關(guān)鍵詞]
[摘要]
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(xué)行為,并與鹽酸吡硫醇注射液進(jìn)行比較,評價鹽酸吡硫醇脂質(zhì)體藥動學(xué)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(yùn)用MasslynxTM NT4.1軟件進(jìn)行數(shù)據(jù)采集;運(yùn)用QuanLynxTM program進(jìn)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(xué)行為相似。結(jié)論 運(yùn)用DAS2.0進(jìn)行生物等效性評價,脂質(zhì)體組與溶液劑組藥動學(xué)參數(shù)均在等效置信區(qū)間內(nèi),兩制劑生物等效。
[Key word]
[Abstract]
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.
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