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Freeze-dried powder preparation of metabolic regulation fusion protein

A fusion protein and metabolic regulation technology, which can be used in metabolic diseases, freeze-dried delivery, peptide/protein components, etc., and can solve problems such as easy aggregation

Active Publication Date: 2020-05-26
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the recombinant human FGF21-Fc fusion protein has a tendency to easily aggregate
There are few reports on the preparation of recombinant human FGF21-Fc fusion protein. Therefore, it is necessary to develop a preparation of FGF21-Fc fusion protein to meet the needs of clinical medication.

Method used

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  • Freeze-dried powder preparation of metabolic regulation fusion protein
  • Freeze-dried powder preparation of metabolic regulation fusion protein
  • Freeze-dried powder preparation of metabolic regulation fusion protein

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] formula:

[0087] FGF21-Fc fusion protein 50mg / ml sucrose 250mM Polysorbate 80 0.02% (W / V) Tris / histidine hydrochloride 20mM pH 8.0

[0088] Preparation process: Weigh the prescription amount of Tris and dissolve it with an appropriate amount of water for injection, adjust the pH to 8.0 with histidine hydrochloride, take a sample to test the pH and endotoxin, and then accurately measure the prescription amount of polysorbate 80, sucrose and recombinant human Add the original solution of FGF21-Fc fusion protein to Tris / histidine hydrochloride buffer solution, mix evenly to obtain the semi-finished solution; filter the semi-finished solution with a 0.22μm filter membrane, and fill it after passing the endotoxin test, as described in the table below Lyophilize with the lyophilization program of Table 9.

[0089] Table 9 Example 1 freeze-drying program

[0090]

[0091]

Embodiment 2

[0093] formula:

[0094] FGF21-Fc fusion protein 30mg / ml Trehalose 50mM Polysorbate 80 0.04% (W / V) Tris / hydrochloric acid 10mM pH 8.5

[0095] Preparation process: Weigh the prescription amount of Tris, dissolve it with an appropriate amount of water for injection, adjust the pH to 8.5 with hydrochloric acid, take a sample to test the pH and endotoxin, and then accurately measure the prescription amount of polysorbate 80, trehalose and recombinant human FGF21- The Fc fusion protein stock solution was added to Tris-hydrochloric acid buffer solution, mixed evenly to obtain a semi-finished product solution; the semi-finished product solution was sterile filtered with a 0.22 μm filter membrane, and the endotoxin was tested to be qualified, then filled, and lyophilized according to the freeze-drying procedure in Table 10.

[0096] Table 10 Example 2 freeze-drying program

[0097]

Embodiment 3

[0099] formula:

[0100]

[0101]

[0102] Preparation process: Weigh the prescription amount of Tris and dissolve it with an appropriate amount of water for injection, adjust the pH to 7.5 with histidine hydrochloride, take a sample to test the pH and endotoxin, and then accurately measure the prescription amount of polysorbate 80, mannitol and recombinant human Add the FGF21-Fc fusion protein stock solution into Tris-hydrochloric acid buffer solution, mix evenly to obtain a semi-finished product solution; filter the semi-finished product solution with a 0.22 μm filter membrane, fill it after passing the endotoxin test, and follow the freeze-drying procedure described in Table 11 lyophilized.

[0103] Table 11 Example 3 freeze-drying program

[0104]

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PUM

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Abstract

The invention belongs to the technical field of protein and polypeptide drugs, and particularly relates to a freeze-dried powder preparation of metabolic regulation fusion protein, which comprises FGF21-Fc fusion protein, a protective agent, a buffer agent and a solubilizer, the preparation method of the preparation, particularly a freeze-drying process, is optimized to obtain the stable FGF21-Fcfusion protein freeze-dried preparation. The freeze-dried preparation prepared by the invention has few auxiliary materials, the potential safety hazard of clinical medication is further reduced, andthe obtained preparation is full in appearance, uniform in texture, rapid in redissolution, good in stability and convenient to store and transport, and the moisture content is lower than 1%.

Description

technical field [0001] The invention belongs to the technical field of protein and polypeptide drugs, and in particular relates to a freeze-dried powder preparation of metabolism regulating fusion protein. Background technique [0002] Fibroblast growth factors are polypeptides expressed in developing and adult tissues. There is a whole family of more than 20 fibroblast growth factors (FGF family). Three members of the FGF family (including FGF19, FGF21, and FGF23) constitute a subfamily that function as endocrine factors involved in metabolic regulation. Fibroblast growth factor 21 or FGF-21 has a molecular weight of 19.5KDa, consists of 181 amino acids, and has 75% homology with mouse FGF21. 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 insulin mass an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61K9/19A61K47/26A61P3/10A61P3/06A61P3/04A61P9/00A61P3/00
CPCA61K38/1825A61K9/19A61K9/0019A61K47/26A61P3/10A61P3/06A61P3/04A61P9/00A61P3/00
Inventor 赵丽丽刘忠
Owner LUNAN PHARMA GROUP CORPORATION
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