min)分別為(1.6±0.4)、(1.6±0.2)mmol/L;達到最低濃度所需時間(tmin)分別為(1.0±0.5)、(1.1±0.6)h.Insulin R和Humulin R的主要藥動學參數(shù)均值分別為：達峰時間(tmax)為(0.43±0.21)、(0.42±0.09)h;峰濃度(Cmax)為(203.2±63.3)、(193.5±63.1)μU/mL;藥時曲線下面積(AUC0-6 h)為(281.2±47.5)、(266.6±62.5)μU/(mL·h);受試藥Insulin R相對于對照藥Humulin R的相對生物利用度為(109.4±25.5)%.結論 兩種重組人胰島素注射劑在健康Beagle犬體內(nèi)具有生物等效性.;Objective To assess the pharmacokinetic and bioequivalence of two formulations of recombinant human insulin injection, using locally manufactured Insulin R as test and Humulin R (Eli Lilly and Company) as reference. Methods Twelve Beagle dogs were assigned into two groups in which the dogs were sc given Insulin R and Humulin R at the dose of 0.5 U/kg according to a randomized two-phase crossover. The plasma concentration of Insulin R and Humulin R at 6 h intervals was determined using radioimmunoassay (RIA) method with the time course of changes in blood glucose level monitored. The pharmacokinetic parameters were calculated by DAS 3.0 software. Results Beagle dogs were treated with Insulin R and Humulin R following single sc administration at the dose of 0.5 U/kg, and the minimum blood glucose levels (Cmin) were (1.6 ± 0.4) and (1.6 ± 0.2) mmol/L, while time to reach minimum blood glucose level (tmin) was (1.0 ± 0.5) and (1.1 ± 0.6) h, respectively. The main pharmacokinetics parameters of Insulin R and Humulin R were as follows: time to reach peak concentration (tmax) was (0.43 ± 0.21) and (0.42 ± 0.09) h; peak concentration (Cmax) was (203.2 ± 63.3) and (193.5 ± 63.1) μU/mL; area under the concentration - time curve (AUC) was (281.2 ± 47.5) and (266.6 ± 62.5) μU/(mL·h), respectively. The relative bioavailability for Insulin R was (109.4 ± 25.5)% compared to that for Humulin R following single sc administration. Conclusion Test and reference drugs meet the regulatory criteria for the pharmacokinetic equivalence, thus Insulin R and Humulin R are bioequivalent."/>

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首頁 > 過刊瀏覽>2014年第29卷第12期 >2014,29(12):1340-1345. DOI:10.7501/j.issn.1674-5515.2014.12.003
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國產(chǎn)與進口重組人胰島素注射液Beagle犬皮下注射的生物等效性研究

Bioequivalence of domestic and imported recombinant human insulin injections after sc administration in Beagle dogs

發(fā)布日期：2014-12-22
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    [關鍵詞]
    [摘要]
    目的 以美國禮來公司重組人胰島素注射液(優(yōu)泌林R,Humulin R)為對照品,評價國產(chǎn)重組人胰島素注射液(Insulin R)的相對生物利用度和生物等效性.方法 采用自身隨機交叉給藥方案,12只健康Beagle犬分別sc同劑量Insulin R和Humulin R,按設計采集6 h內(nèi)動態(tài)血標本.采用羅氏血糖儀與檢測血藥濃度同步測定動物血糖水平;放射免疫分析(RIA)法檢測血藥濃度;試驗數(shù)據(jù)采用DAS 3.0藥動學程序擬合計算參數(shù),并進行生物等效性分析.結果 Beagle犬自身交叉sc Insulin R和Humulin R 0.5 U/kg后的血漿最低葡萄糖濃度(Cmin)分別為(1.6±0.4)、(1.6±0.2)mmol/L;達到最低濃度所需時間(tmin)分別為(1.0±0.5)、(1.1±0.6)h.Insulin R和Humulin R的主要藥動學參數(shù)均值分別為：達峰時間(tmax)為(0.43±0.21)、(0.42±0.09)h;峰濃度(Cmax)為(203.2±63.3)、(193.5±63.1)μU/mL;藥時曲線下面積(AUC0-6 h)為(281.2±47.5)、(266.6±62.5)μU/(mL·h);受試藥Insulin R相對于對照藥Humulin R的相對生物利用度為(109.4±25.5)%.結論 兩種重組人胰島素注射劑在健康Beagle犬體內(nèi)具有生物等效性.
    [Key word]
    [Abstract]
    Objective To assess the pharmacokinetic and bioequivalence of two formulations of recombinant human insulin injection, using locally manufactured Insulin R as test and Humulin R (Eli Lilly and Company) as reference. Methods Twelve Beagle dogs were assigned into two groups in which the dogs were sc given Insulin R and Humulin R at the dose of 0.5 U/kg according to a randomized two-phase crossover. The plasma concentration of Insulin R and Humulin R at 6 h intervals was determined using radioimmunoassay (RIA) method with the time course of changes in blood glucose level monitored. The pharmacokinetic parameters were calculated by DAS 3.0 software. Results Beagle dogs were treated with Insulin R and Humulin R following single sc administration at the dose of 0.5 U/kg, and the minimum blood glucose levels (Cmin) were (1.6 ± 0.4) and (1.6 ± 0.2) mmol/L, while time to reach minimum blood glucose level (tmin) was (1.0 ± 0.5) and (1.1 ± 0.6) h, respectively. The main pharmacokinetics parameters of Insulin R and Humulin R were as follows: time to reach peak concentration (tmax) was (0.43 ± 0.21) and (0.42 ± 0.09) h; peak concentration (Cmax) was (203.2 ± 63.3) and (193.5 ± 63.1) μU/mL; area under the concentration - time curve (AUC) was (281.2 ± 47.5) and (266.6 ± 62.5) μU/(mL·h), respectively. The relative bioavailability for Insulin R was (109.4 ± 25.5)% compared to that for Humulin R following single sc administration. Conclusion Test and reference drugs meet the regulatory criteria for the pharmacokinetic equivalence, thus Insulin R and Humulin R are bioequivalent.
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