Lyophilized preparation of metabolic modulatory fusion protein

A technology of freeze-dried preparations and fusion proteins, which is applied in the field of freeze-dried preparations for metabolically regulated fusion proteins, which can solve the problems of easy aggregation and instability of proteins, and achieve the effects of rapid reconstitution, good drying effect, and uniform texture

Active Publication Date: 2021-02-23
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, in view of the technical problem that the recombinant human FGF21-Fc fusion protein is easy to aggregate and be unstable, it is necessary to develop a stable FGF21-Fc fusion protein preparation to meet the needs of clinical medication.

Method used

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  • Lyophilized preparation of metabolic modulatory fusion protein
  • Lyophilized preparation of metabolic modulatory fusion protein
  • Lyophilized preparation of metabolic modulatory fusion protein

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] (1) Prescription

[0037]

[0038] (2) Preparation method

[0039] Weigh the prescribed amount of Tris, dissolve it with an appropriate amount of water for injection, adjust the pH with hydrochloric acid, take a sample to test the pH and endotoxin, and then accurately weigh the prescribed amount of maltose, hydroxyethyl starch, sodium glutamate, Tween 80 and recombinant Add the FGF21-Fc fusion protein stock solution into Tris / HCl buffer solution, mix evenly to get the semi-finished solution, filter the semi-finished solution with a 0.22μm filter membrane, and fill it into a vial after passing the endotoxin test. 7ml vial, the filling volume is 1ml.

[0040] (3) Freeze-drying process

[0041] 1) Pre-freezing: first place the vial containing the recombinant FGF21-Fc fusion protein solution on the partition plate of the freeze dryer, set the temperature for pre-freezing at 2°C, set the time for 10 minutes to reach the preset temperature, maintain it for 30 minutes, and ...

Embodiment 2

[0045] (1) Prescription

[0046]

[0047]

[0048] The preparation method and freeze-drying process are the same as in Example 1.

Embodiment 3

[0050] (1) Prescription

[0051]

[0052] (2) Preparation method

[0053] Weigh the prescribed amount of Tris, dissolve it with an appropriate amount of water for injection, adjust the pH with hydrochloric acid, take a sample to test the pH and endotoxin, and then accurately weigh the prescribed amount of maltose, hydroxyethyl starch, sodium glutamate, Tween 80 and recombinant Add the FGF21-Fc fusion protein stock solution into Tris / HCl buffer solution, mix evenly to get the semi-finished solution, filter the semi-finished solution with a 0.22μm filter membrane, and fill it into a vial after passing the endotoxin test. 7ml vial, the filling volume is 1ml.

[0054] (3) Freeze-drying process

[0055] 1) Pre-freezing: first place the vial containing the recombinant FGF21-Fc fusion protein solution on the partition plate of the freeze dryer, set the temperature for pre-freezing at 2°C, set the time for 10 minutes to reach the preset temperature, maintain it for 30 minutes, an...

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a lyophilized preparation of metabolic modulatory fusion protein. The lyophilized preparation is a freeze-dried FGF21 Fc fusion protein preparation which takes a composition of hydroxyethyl starch and sodium glutamate as a protective agent, and is good in stability, full in appearance and uniform in texture. In addition, a preparation method of the lyophilized preparation is simple in process, suitable for amplification, controllable in quality, and good in drying effect; and the lyophilized preparation prepared by the preparation method is low in water content, as well as convenient to store and transport.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation of a metabolic regulation 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 known as the FGF family. The three members of the FGF family, including FGF19, FGF21 and FGF23, constitute a subfamily that function as endocrine factors involved in metabolic regulation. [0003] FGF21 is a regulator of cellular metabolism that functions as an important metabolic regulator of glucose and lipid homeostasis. By upregulating GLUT1 expression, FGF21 promotes glucose uptake in adipocytes through a different mechanism than insulin. In diabetic rodents and monkeys, human FGF21 reduces fasting serum concentrations of glucose and reduces fasting serum concentrations of triglycerides, insuli...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/36A61K47/18A61K47/26A61K38/18A61K47/68
CPCA61K9/19A61K47/36A61K47/183A61K47/26A61K38/1825A61K47/6811
Inventor 张贵民赵丽丽赵青松
Owner LUNAN PHARMA GROUP CORPORATION
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