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人胰岛素(重组DNA)的临床药理学研究。

Clinical pharmacologic studies with human insulin (recombinant DNA).

作者信息

Galloway J A, Root M A, Bergstrom R, Spradlin C T, Howey D C, Fineberg S E, Jackson R L

出版信息

Diabetes Care. 1982 Nov-Dec;5 Suppl 2:13-22. doi: 10.2337/diacare.5.2.s13.

Abstract

Normal fasting subjects were used to study the pharmacokinetics of human insulin (recombinant DNA). Purified pork insulin (PPI) was used as a control agent. There was no difference in serum concentrations between neutral regular human insulin and PPI after intravenous administration. When given subcutaneously, peak concentrations are occasionally higher for human insulin than for PPI. The bioavailability indices for the two insulins are essentially the same. NPH human insulin produced a slightly higher serum concentration after 4 h than did NPH PPI. Studies with 70/30 NPH-regular mixtures suggest that the affinity of protamine for human insulin is less than that for PPI. The serum insulin concentrations after lente human insulin and PPI were not different. These studies, and a review of the published clinical pharmacologic literature, indicate that when present the differences between human insulin and PPI are minimal.

摘要

正常空腹受试者被用于研究人胰岛素(重组DNA)的药代动力学。纯化猪胰岛素(PPI)用作对照药物。静脉给药后,中性正规人胰岛素和PPI的血清浓度无差异。皮下给药时,人胰岛素的峰值浓度偶尔高于PPI。两种胰岛素的生物利用度指标基本相同。NPH人胰岛素在4小时后的血清浓度略高于NPH PPI。对70/30 NPH-正规混合物的研究表明,鱼精蛋白对人胰岛素的亲和力低于对PPI的亲和力。长效人胰岛素和PPI后的血清胰岛素浓度无差异。这些研究以及对已发表临床药理学文献的综述表明,人胰岛素和PPI之间即使存在差异也是极小的。

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