胰岛素和胰淀素联合制剂的新进展

Iskandar Idris
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引用次数: 1

摘要

胰淀素是一种由胰腺β细胞与胰岛素一起分泌的小肽激素。胰淀素起中枢作用,减缓胃排空,抑制餐后胰高血糖素分泌,减少食物摄入,从而补充胰岛素调节血糖水平的作用。在1型糖尿病患者中,胰淀素的产生是完全不存在的。多年来使用稳定的胰淀素普兰利肽的研究表明,在用餐时联合使用胰岛素和胰淀素类似物治疗糖尿病比单独使用胰岛素更有效。然而,由于胰岛素和胰淀素类似物作为两种单独的注射剂给药不切实际,其临床发展受到限制(因为这些蛋白质不能共同配制)。最近,斯坦福大学的研究人员开发了一种新的配方,可以将胰岛素(Humalog Lisipro;礼来)和Symlin(普兰利肽;阿斯利康)作为单次注射。研究人员开发的新配方包括一种由聚乙二醇制成的分子包装物,经过设计可以选择性地与胰淀素和胰岛素分子结合。这种保护元件保护这两种化合物,直到它们被注射到体内,这时它们从包装物上解开,正常发挥作用。该配方已在动物模型上进行了测试,并被证明能有效模拟人体内源性这两种重要激素的共同分泌。该制剂还被发现稳定超过100小时,这意味着它可以通过植入的胰岛素泵有效储存和给药。因此,需要进一步的临床研究来证明其对1型或2型糖尿病患者的疗效。这项关于胰岛素和胰淀素联合制剂的最新研究发表在《自然生物医学工程》杂志上。
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Novel development of a co-formulation of insulin and Amylin

Amylin is a small peptide hormone excreted alongside insulin by pancreatic beta cells. Amylin acts centrally to slow gastric emptying, suppress postprandial glucagon secretion, and decrease food intake, thus complementing the action of insulin to regulate blood glucose levels. In people with type 1 diabetes, amylin production is completely absent. Studies for many years using the stable Amylin, pramlitide have shown that treatment of diabetes with a combination of insulin and amylin analogues at meal times are more effective than insulin alone. However its clinical development is limited due to the impracticality of administering insulin and amylin analogues as two separate injections (since these proteins can't be co-formulated). More recently, investigators from Stanford University have developed a novel formulation which enabled insulin (Humalog Lisipro; Eli Lilly) and Symlin (pramlitide; AstraZeneca) to be given as a single injection. The novel formulation developed by the researchers involves a molecular wrapper made out of polyethylene glycol, engineered to selectively bind to amylin and insulin molecules. This protective element shields the two compounds until they are injected into a body, at which point they unbind from the wrapper and function as normal. The formulation has been tested on animal models and shown to be effective in mimicking the body's endogenous co-secretions of these two important hormones. The formulation has also been found to be stable for over 100 hours, meaning it could be effectively stored and administered by an implanted insulin pump. Further clinical studies are therefore required to show its efficacy in people with type 1 or type 2 diabetes. This recent study on the co-formulation of insulin and Amylin was published in the journal Nature Biomedical Engineering.

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