Human fgf21 lyophilized preparation

Abstract

The invention provides a freeze-dried (lyophilized) preparation of human FGF21. The preparation includes human FGF21 and accessories, wherein the accessories include trehalose, mannitol, sorbitol, arginine, glycine and / or poloxamer.

Description

technical field [0001] The invention belongs to the technical field of protein or polypeptide medicine, in particular, the invention relates to a freeze-dried (lyophilized) preparation of human FGF21. [0002] technical background [0003] Fibroblast growth factor-21 (FGF21) is a member of the fibroblast growth factor family, which belongs to the same subfamily as FGF19 and FGF23. homology. FGF21 is a regulator of cellular metabolism that exhibits multiple beneficial effects in vivo and in vitro, such as inhibition of hepatic glucose production, stimulation of glucose uptake in adipose tissue, increased brown adipose tissue thermogenesis, preservation of islet mass and insulin levels without mitogenicity effects or other side effects. FGF21 can be used as a substitute for insulin and GLP1 analogs, and is a very promising drug for the treatment of type II diabetes. [0004] However, long-term research and clinical practice have shown that FGF21, like other protein drugs, ha...

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Problems solved by technology

[0004] However, long-term research and clinical practice have shown that FGF21, like other protein drugs, has disadvantages such as poor stability and short storage period, which affect its therapeutic effect (Wen-Bing Y, Gui-Ping R, Yang H, et al. Expression and pharmacological evaluation of fusion protein FGF21-L-Fc[J].Acta Pharmaceutical Sinica,2011,46(7):787-792)

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