1/2為(2.62±2.14)、(1.99±1.37)h;平均Cmax為(108.30±26.90)、(104.60±18.45)μU/mL;平均tmax為(0.94±0.43)、(0.90±0.39)h;平均AUC(0-t)為(362.3±73.6)、(351.7±53.9)μU/(mL·h)。血漿最低葡萄糖濃度(Cmin)分別為(1.74±0.25)、(1.80±0.33)mmol/L,達(dá)到最低濃度所需時間(tmin)分別為(1.58±0.97)、(2.02±0.96) h。結(jié)論 精蛋白重組人胰島素注射液(預(yù)混50/50)與50/50混合重組人胰島素注射液在Beagle犬體內(nèi)具有生物等效性。;Objective To investigate the pharmacokinetic and bioequivalence of Isophane Protamine Recombinant Human Insulin Injection (pre-mixed 50/50) and 50/50 Mixture Recombinant Human Insulin Injection after sc administration in Beagle dogs. Methods Twelve healthy Beagle dogs dogs were divided into two groups, and the dogs in two groups were separately singlely sc injected with Isophane Protamine Recombinant Human Insulin Injection (pre-mixed 50/50) and 50/50 Mixture Recombinant Human Insulin Injection in the same dose according to a randomized two-phase crossover. The plasma was sampled at different time points after sc administration, and the blood glucose levels were determined by Roche Glucose meter synchronously. The radioimmunoassay (RIA) method was used to determine the concentration of blood insulin at the different sample points. The pharmacokinetic parameters were calculated by DAS 2.0 Software. Results Beagle's dogs were treated with test preparation and reference preparation following single sc administration at the dose of 5 U/animal. The main pharmacokinetic parameters of test preparation and reference preparation were as following: The elimination half-life (t1/2) was (2.62 ± 2.14) and (1.99 ± 1.37) h, the peak concentration (Cmax) was (108.30 ± 26.90) and (104.60 ± 18.45) μU/mL, the peak time (tmax) was (0.94 ± 0.43) and (0.90 ± 0.39) h, and the area under the concentration-time curve (AUC(0-t)) was (362.3 ± 73.6) and (351.7 ± 53.9) μU/(mL·h), respectively. What's more, the minimum blood glucose levels (Cmin) of the tested and referenced samples were (1.74 ± 0.25) and (1.80 ± 0.33) mmol/L, respectively, and the tmin (time to reach minimum blood glucose level) was (1.58 ± 0.97) and (2.02 ± 0.96) h, respectively. Conclusion Isophane Protamine Recombinant Human Insulin Injection (pre-mixed 50/50) and 50/50 Mixture Recombinant Human Insulin Injection are bioequivalent in the therapy effect."/>

醉酒后少妇被疯狂内射视频,一本色道久久综合一,在线天堂新版资源www在线下载,中文字幕乱人伦高清视频,中字幕视频在线永久在线观看免费

首頁 > 過刊瀏覽>2015年第30卷第9期 >2015,30(9):1057-1062. DOI:10.7501/j.issn.1674-5515.2015.09.002
上一篇 | 下一篇

精蛋白重組人胰島素注射液(預(yù)混50/50)與50/50混合重組人胰島素注射液在Beagle犬體內(nèi)的生物等效性研究

Bioequivalence of Isophane Protamine Recombinant Human Insulin Injection (pre-mixed 50/50) and 50/50 Mixture Recombinant Human Insulin Injection after sc administration in Beagle dogs

發(fā)布日期：2015-09-24
  • 摘要
  • 圖/表
  • 訪問統(tǒng)計
  • PDF預(yù)覽
  • 參考文獻(xiàn)
  • 相似文獻(xiàn)
  • 引證文獻(xiàn)
  • 附件
    [關(guān)鍵詞]
    [摘要]
    目的 研究精蛋白重組人胰島素注射液(預(yù)混50/50)與已上市的50/50混合重組人胰島素注射液在Beagle犬體內(nèi)的藥動學(xué)和生物等效性。方法 采用單劑量試驗制劑和參比制劑自身雙交叉給藥方案,12只健康Beagle犬分別皮下注射同劑量精蛋白重組人胰島素注射液(預(yù)混50/50)和50/50混合重組人胰島素注射液,給藥后不同時間經(jīng)靜脈采集血漿標(biāo)本,同時采用羅氏血糖儀同步測定動物血糖水平;放射免疫分析(RIA)法檢測血藥濃度;血藥濃度數(shù)據(jù)用DAS 2.0藥動學(xué)軟件擬合計算參數(shù),并進(jìn)行生物等效性分析。結(jié)果 Beagle犬交叉sc 5 U/只試驗制劑與參比制劑后,主要藥動學(xué)參數(shù)分別為:平均t1/2為(2.62±2.14)、(1.99±1.37)h;平均Cmax為(108.30±26.90)、(104.60±18.45)μU/mL;平均tmax為(0.94±0.43)、(0.90±0.39)h;平均AUC(0-t)為(362.3±73.6)、(351.7±53.9)μU/(mL·h)。血漿最低葡萄糖濃度(Cmin)分別為(1.74±0.25)、(1.80±0.33)mmol/L,達(dá)到最低濃度所需時間(tmin)分別為(1.58±0.97)、(2.02±0.96) h。結(jié)論 精蛋白重組人胰島素注射液(預(yù)混50/50)與50/50混合重組人胰島素注射液在Beagle犬體內(nèi)具有生物等效性。
    [Key word]
    [Abstract]
    Objective To investigate the pharmacokinetic and bioequivalence of Isophane Protamine Recombinant Human Insulin Injection (pre-mixed 50/50) and 50/50 Mixture Recombinant Human Insulin Injection after sc administration in Beagle dogs. Methods Twelve healthy Beagle dogs dogs were divided into two groups, and the dogs in two groups were separately singlely sc injected with Isophane Protamine Recombinant Human Insulin Injection (pre-mixed 50/50) and 50/50 Mixture Recombinant Human Insulin Injection in the same dose according to a randomized two-phase crossover. The plasma was sampled at different time points after sc administration, and the blood glucose levels were determined by Roche Glucose meter synchronously. The radioimmunoassay (RIA) method was used to determine the concentration of blood insulin at the different sample points. The pharmacokinetic parameters were calculated by DAS 2.0 Software. Results Beagle's dogs were treated with test preparation and reference preparation following single sc administration at the dose of 5 U/animal. The main pharmacokinetic parameters of test preparation and reference preparation were as following: The elimination half-life (t1/2) was (2.62 ± 2.14) and (1.99 ± 1.37) h, the peak concentration (Cmax) was (108.30 ± 26.90) and (104.60 ± 18.45) μU/mL, the peak time (tmax) was (0.94 ± 0.43) and (0.90 ± 0.39) h, and the area under the concentration-time curve (AUC(0-t)) was (362.3 ± 73.6) and (351.7 ± 53.9) μU/(mL·h), respectively. What's more, the minimum blood glucose levels (Cmin) of the tested and referenced samples were (1.74 ± 0.25) and (1.80 ± 0.33) mmol/L, respectively, and the tmin (time to reach minimum blood glucose level) was (1.58 ± 0.97) and (2.02 ± 0.96) h, respectively. Conclusion Isophane Protamine Recombinant Human Insulin Injection (pre-mixed 50/50) and 50/50 Mixture Recombinant Human Insulin Injection are bioequivalent in the therapy effect.
    [中圖分類號]
    [基金項目]
    國家重大新藥創(chuàng)制科技重大專項(2012ZX09304002)