【摘要】：目的 評(píng)價(jià)國(guó)產(chǎn)與國(guó)外已上市的重組人胰島素注射液在Beagle犬體內(nèi)的藥代動(dòng)力學(xué)及生物等效性。方法 用兩制劑、雙周期、自身對(duì)照隨機(jī)交叉單劑量實(shí)驗(yàn)設(shè)計(jì)。12只健康Beagle犬分為實(shí)驗(yàn)組(試驗(yàn)藥)和對(duì)照組(對(duì)照藥),每組5只,皮下注射重組人胰島素5 U,不同時(shí)間經(jīng)靜脈采集血漿,測(cè)定動(dòng)物血糖水平;放射免疫分析(RIA)法檢測(cè)血藥濃度;用DAS 2.0軟件擬合計(jì)算藥代動(dòng)力學(xué)參數(shù),并進(jìn)行生物等效性分析。結(jié)果 實(shí)驗(yàn)組和對(duì)照組胰島素主要藥代動(dòng)力學(xué)參數(shù):t1/2為(1.06±0.17),(1.06±0.35)h;Cmax為(97.10±45.20),(91.30±28.20)μU·m L-1;tmax為(0.49±0.19),(0.49±0.18)h;AUC0-t為(168.00±40.50),(168.00±41.90)μU·m L-1·h。血漿最低葡萄糖濃度(Cmin)分別為(1.36±0.28),(1.37±0.34)mmol·L-1,最低濃度所需時(shí)間(tmin)分別為(1.57±0.55),(1.74±0.65)h。Cmax和AUC0-t[1-2α]置信區(qū)間分別為85.5%~117.7%和97.0%~103.3%。結(jié)論 2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。
[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 鹵0.17), (1.06 鹵0.35), (, C max (97.10 鹵45.20), (, 91.30 鹵28.20) 渭 U mL -1 tmax, (0.49 鹵0.19), (0.49 鹵0.18) h AUC0-t, (168.00 鹵40.50), (, 168.00 鹵41.90) 渭 U mL -1 h, respectively. The minimum plasma glucose concentration (Cmin) was (1.36 鹵0.28), (, 1.37 鹵0.34) mmol L ~ (-1), the minimum concentration time (tmin) was (1.57 鹵0.55), (1.74 鹵0.65) h.Cmax and AUC0-t [1-2 偽] confidence intervals were 85.5% and 103.3%, respectively. Conclusion two recombinant human insulin injections are bioequivalent in healthy Beagle dogs.
【作者單位】： 天津醫(yī)科大學(xué)藥學(xué)院;天津藥物研究院有限公司釋藥技術(shù)與藥代動(dòng)力學(xué)國(guó)家重點(diǎn)實(shí)驗(yàn)室;合肥天麥生物科技發(fā)展有限公司;
【分類號(hào)】：R969.1;;R977.15

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