Human fgf21 lyophilized preparation

A technology of FGF21 and freeze-dried preparations, which is applied in freeze-dried delivery, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. Excellent Tg index, large protective effect and strong stability

Active Publication Date: 2020-06-26
WENZHOU MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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)

Method used

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  • Human fgf21 lyophilized preparation
  • Human fgf21 lyophilized preparation
  • Human fgf21 lyophilized preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0019] 1. Experimental Instruments and Materials

[0020] 1.1 Experimental Instruments

[0021] pH meter: Shanghai Precision Scientific Instrument Co., Ltd. SNB-4 acidity meter

[0022] CO 2 Incubator: Shanghai Xinmiao Medical Device Manufacturing Co., Ltd. BB15

[0023] Electronic analytical balance: Shanghai Fangrui Instrument Co., Ltd. FA2204

[0024] Freeze dryer: Shanghai Tofflon 20

[0025] Multifunctional microplate reader: American MD SpectraMax M3

[0026] Osmometer: American Advanced Fiske 110

[0027] Moisture Analyzer: Mettler DL37

[0028] Electric constant temperature incubator: Shanghai Senxin Experimental Instrument Co., Ltd. DRP-9052

[0029] Infrared spectrometer: American Nicolet Magna 560ESP

[0030] Differential scanning calorimeter: American TA DSC Q-600

[0031] Electrophoresis instrument, gel imager: Bio-Rad

[0032] HPLC: Agilent 1200

[0033] Vertical pressure steam sterilizer: Shanghai Boxun Industrial Co., Ltd. Medical Equipment Factory Y...

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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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/18A61K9/19A61K47/26A61K47/18A61K47/10A61K47/02A61P3/10
CPCA61K9/19A61K38/1825A61K47/02A61K47/10A61K47/183A61K47/26
Inventor 王晓杰李校堃惠琦余丙洁
Owner WENZHOU MEDICAL UNIV
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