中国临床药理学与治疗学2017，Vol.22Issue(9)：992-997,6.
国产甘精胰岛素注射剂在Beagle犬体内的毒代动力学研究
Toxicokinetic study of insulin glargine injection in Beagle dogs
摘要
Abstract
To investigate the toxicokinet-ic behaviors of domestic and imported insulin glargine injection in Beagle dogs.METHODS:Forty healthy Beagle dogs were randomly divided into four groups.The levels of insulin were subcutaneously given at domestic insulin glargine Low group A (0.5 U/kg),Middle group B (1.0 U/kg),High group C (1.5 U/kg) and group D Lantus(R)(1.5 U/kg),respectively for 30 days.Blood samples were collected at preset time points on day 1,day 15 and day 30;RIA method was used for determination of insulin levels in plasma concentration;calculation of toxicokinetic parameters was completed by using DAS 2.2 software;SPSS 17.0 was used for statistical analysis.RESULTS:The average AUC0-t of group A was (870.24 ± 194.30) and (723.01 ± 223.88) μU · mL-1 · h on day 1 and day 30 after subcutaneous administration;the mean Cmax was (98.55 ±41.24),(84.92 ±25.64) μU/mL.Average AUC0-t of group B was (1 298.92 ± 386.13)and (1375.53±376.68) μU· mL-1 · h on day 1 and day 30;the mean Cmax was (157.58 ±46.89),(212.90 ± 72.71) μU/mL,individually.And the average AUC0-t of the group C and group D on first day was (1777.91 ± 209.46),(1960.81 ± 171.56) μU mL-1 · h;the mean Cmax was (231.49 ±36.37) and (232.87 ±32.09) μU/mL;the average AUC0-t of 30th day individually was (1 734.59 ± 612.29),(1 639.90 ± 285.91) μU · mL-1 · h;the average Cmax was (289.30 ± 121.87),(247.64 ± 44.29) μU/mL.CONCLUSION:Domestic insulin glargine injection and reference agent (Lantus(R),Sanofi) in beagle dogs have no accumulation phenomenon after multiple administrations,which was consistent with the results in Beagle dogs.关键词
甘精胰岛素/毒代动力学/Beagle犬/皮下注射Key words
insulin glargine/toxicokinetic/beagle dogs/subcutaneous injection (sc)分类
医药卫生引用本文复制引用
张星艳,李俊,李亚卓,魏滋鸿,武卫党,李薇,路江杰,朱虹,张宗鹏,曾勇..国产甘精胰岛素注射剂在Beagle犬体内的毒代动力学研究[J].中国临床药理学与治疗学,2017,22(9):992-997,6.基金项目
国家“重大新药创制”科技重大专项(2012ZX09304002) （2012ZX09304002）
国家重点研发计划(2016YFE0121400) （2016YFE0121400）
