国产重组人胰岛素生物等效性研究
发布时间：2018-09-09 17:46
【摘要】：目的 评价国产与国外已上市的重组人胰岛素注射液在Beagle犬体内的药代动力学及生物等效性。方法 用两制剂、双周期、自身对照随机交叉单剂量实验设计。12只健康Beagle犬分为实验组(试验药)和对照组(对照药),每组5只,皮下注射重组人胰岛素5 U,不同时间经静脉采集血浆,测定动物血糖水平;放射免疫分析(RIA)法检测血药浓度;用DAS 2.0软件拟合计算药代动力学参数,并进行生物等效性分析。结果 实验组和对照组胰岛素主要药代动力学参数:t1/2为(1.06±0.17),(1.06±0.35)h;Cmax为(97.10±45.20),(91.30±28.20)μU·m L-1;tmax为(0.49±0.19),(0.49±0.18)h;AUC0-t为(168.00±40.50),(168.00±41.90)μU·m L-1·h。血浆最低葡萄糖浓度(Cmin)分别为(1.36±0.28),(1.37±0.34)mmol·L-1,最低浓度所需时间(tmin)分别为(1.57±0.55),(1.74±0.65)h。Cmax和AUC0-t[1-2α]置信区间分别为85.5%~117.7%和97.0%~103.3%。结论 2种重组人胰岛素注射剂在健康Beagle犬体内具有生物等效性。
[Abstract]:Objective to evaluate the pharmacokinetics and bioequivalence of recombinant human insulin injection in Beagle dogs. Methods 12 healthy Beagle dogs were randomly divided into experimental group (experimental group) and control group (control group) with 5 in each group. After subcutaneous injection of recombinant human insulin for 5 U, plasma was collected through vein at different time, blood glucose level was measured by radioimmunoassay (RIA), pharmacokinetic parameters were calculated by DAS 2.0 software, and bioequivalence analysis was carried out. Results the main pharmacokinetic parameters of insulin in experimental group and control group were (1.06 卤0.17), (1.06 卤0.35), (, C max (97.10 卤45.20), (, 91.30 卤28.20) 渭 U mL -1 tmax, (0.49 卤0.19), (0.49 卤0.18) h AUC0-t, (168.00 卤40.50), (, 168.00 卤41.90) 渭 U mL -1 h, respectively. The minimum plasma glucose concentration (Cmin) was (1.36 卤0.28), (, 1.37 卤0.34) mmol L ~ (-1), the minimum concentration time (tmin) was (1.57 卤0.55), (1.74 卤0.65) h.Cmax and AUC0-t [1-2 伪] confidence intervals were 85.5% and 103.3%, respectively. Conclusion two recombinant human insulin injections are bioequivalent in healthy Beagle dogs.
【作者单位】： 天津医科大学药学院;天津药物研究院有限公司释药技术与药代动力学国家重点实验室;合肥天麦生物科技发展有限公司;
【分类号】：R969.1;;R977.15
[Abstract]:Objective to evaluate the pharmacokinetics and bioequivalence of recombinant human insulin injection in Beagle dogs. Methods 12 healthy Beagle dogs were randomly divided into experimental group (experimental group) and control group (control group) with 5 in each group. After subcutaneous injection of recombinant human insulin for 5 U, plasma was collected through vein at different time, blood glucose level was measured by radioimmunoassay (RIA), pharmacokinetic parameters were calculated by DAS 2.0 software, and bioequivalence analysis was carried out. Results the main pharmacokinetic parameters of insulin in experimental group and control group were (1.06 卤0.17), (1.06 卤0.35), (, C max (97.10 卤45.20), (, 91.30 卤28.20) 渭 U mL -1 tmax, (0.49 卤0.19), (0.49 卤0.18) h AUC0-t, (168.00 卤40.50), (, 168.00 卤41.90) 渭 U mL -1 h, respectively. The minimum plasma glucose concentration (Cmin) was (1.36 卤0.28), (, 1.37 卤0.34) mmol L ~ (-1), the minimum concentration time (tmin) was (1.57 卤0.55), (1.74 卤0.65) h.Cmax and AUC0-t [1-2 伪] confidence intervals were 85.5% and 103.3%, respectively. Conclusion two recombinant human insulin injections are bioequivalent in healthy Beagle dogs.
【作者单位】： 天津医科大学药学院;天津药物研究院有限公司释药技术与药代动力学国家重点实验室;合肥天麦生物科技发展有限公司;
【分类号】：R969.1;;R977.15
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