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以SNAC吸收增强作用为基础的索玛鲁肽片剂研究进展

Progress of Semaglutide Tablets Based on SNAC Absorption Enhancement
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摘要 目的回顾索玛鲁肽片剂临床研究,总结其作用机制、安全性及有效性。方法追踪诺和诺德公司药品研究进展,综合分析相关临床研究结果。结果索玛鲁肽片剂主要包含胰高血糖素样肽-1(GLP-1)类似物索玛鲁肽与吸收促进剂N-(8-[2-羟苯甲酰氨基])辛酸钠(SNAC)。临床研究表明,人体对索玛鲁肽片剂吸收良好,疗效也显著优于安慰剂。诺和诺德公司正积极向FDA申请索玛鲁肽片剂上市许可。结论索玛鲁肽片剂在人体的吸收依赖于SNAC的吸收促进作用,而这一作用的发挥受肠道环境影响较大。为适应索玛鲁肽片剂的作用特点,研究人员总结出一套新的给药方法,取得了不错的疗效,但也发现其在胃肠道等方面的不良反应。 Objective To review the clinical studies of Semaglutide Tablets and summarize its mechanism,safety and efficacy.Methods The progress of drug research of Novo Nordisk was tracked and the relevant clinical research results were analyzed.Results Semaglutide Tablets contains glucagon-like peptide-1(GLP-1)analogue,seamglutide and absorption enhancer,sodium N-(8-[2-hydroxybenzoyl amino])caprylate(SNAC).Clinical studies showed good adsorption of Semaglutide Tablets in human body and much better curative effect than placebo.Novo Nordisk is now applying for FDA approval for Semaglutide Tablets.Conclusion The absorption of Semaglutide Tablets in human body depends on the absorption promoting effect of SNAC,which is greatly affected by the intestinal environment.In order to adapt to the characteristics of Semaglutide Tablets,a new set of drug delivery methods are proposed,which have gained good effects,but gastrointestinal side effects are also observed.
作者 李丹 刘颜 韩伟杰 LI Dan;LIU Yan;HAN Wei-jie(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;School of Pharmacy,Chongqing Medical University,Chongqing 400016,China)
出处 《食品与药品》 CAS 2019年第6期I0004-I0012,共9页 Food and Drug
关键词 索玛鲁肽片剂 SNAC 临床研究 2型糖尿病 Semaglutide Tablets SNAC clinical research type 2 diabetes
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