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Recombinant human fibroblast growth factor-9 protein drug freeze-dried preparation and application thereof

A technology of human fibroblasts and fibroblasts, applied in freeze-drying delivery, drug combination, drug delivery and other directions, can solve the problems of difficult to use biological agents, easy to break, unstable peptide bonds, etc., to protect the antioxidant capacity , reducing inflammation and protecting protein stability

Pending Publication Date: 2022-03-25
温州医科大学慈溪生物医药研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the amino acid sequence of FGF-9 contains a large number of basic amino acids (lysine, arginine, etc.), and a large number of negatively charged amino acids gather and repel each other, resulting in unstable and easy to break peptide bonds.
Therefore, it is difficult to prepare it for use as a biopharmaceutical

Method used

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  • Recombinant human fibroblast growth factor-9 protein drug freeze-dried preparation and application thereof
  • Recombinant human fibroblast growth factor-9 protein drug freeze-dried preparation and application thereof
  • Recombinant human fibroblast growth factor-9 protein drug freeze-dried preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1 Preparation method of recombinant human fibroblast growth factor-9 protein drug freeze-dried preparation Solution preparation and filling method of freeze-dried preparation solution with different proportions:

[0023] 1) Preparation of protein solution: the purified FGF9 protein was dialyzed in 25mM citrate buffer (pH 6.0) and concentrated by ultrafiltration to a protein concentration of 6.5mg / ml, sterilized with a sterile 0.22μm microporous membrane Use after filtering. The above operations are all carried out at 2-8 °C;

[0024] 2) Preparation of auxiliary material solution: accurately weigh each component according to the formulas designed in Table 1 below, and fully dissolve it with 25mM citrate buffer (pH6.0), adjust the pH to 6.0, and use sterile 0.22μm After sterilization and filtration by microporous membrane, place it at 2-8℃ to pre-cool for use;

[0025] 3) Mixing the protein solution and the auxiliary material solution 1:1 (v / v) to make the pr...

Embodiment 2

[0034] Example 2: Detection of the stability of recombinant human fibroblast growth factor-9 protein drug freeze-dried preparations of each prescription by non-reducing SDS-PAGE gel electrophoresis

[0035] The protein purity of different formulations at 0, 3, 6, 9, and 12 months was detected by non-reducing SDS-PAGE gel electrophoresis under the storage conditions of 5±3°C and RH 65%. The specific operations are as follows:

[0036] 1) Electrophoresis protein sample preparation: The preserved FGF9 protein lyophilized preparation was dissolved with water for injection at each time point and diluted to 1 mg / ml. Precisely pipette 60 μl, add 20 μl 4× non-reducing sample treatment solution, mix well, boil at 100°C for 10 min, and centrifuge at 13000 rpm for 10 min.

[0037] 2) Electrophoresis gel preparation: 12% separating gel was prepared according to the SDS-polyacrylamide gel electrophoresis method in the general rule of the Pharmacopoeia, capped with water, and polymerized at ...

Embodiment 3

[0044] Example 3: Detection of the stability of recombinant human fibroblast growth factor-9 protein drug freeze-dried preparations of each prescription by cell proliferation method / MTT colorimetric method

[0045] Using NIH / 3T3 cells as the detection cell line, the biological activity of different formulations at 0, 3, 6, 9, and 12 months was determined by cell proliferation method / MTT colorimetric method under the storage conditions of 5±3℃ and RH 65%. academic activity. The specific operations are as follows:

[0046] 1) Preparation of standard solution: Take one fibroblast growth factor standard product purchased by the China Inspection and Quarantine, dissolve it with 1ml of maintenance culture medium and dispense it to 40IU / ml. In a 96-well cell culture plate, make 4-fold serial dilutions with 2 wells per dilution. The above operations were carried out under sterile conditions.

[0047] 2) Preparation of test solution: Dilute FGF9 protein with maintenance medium to ab...

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Abstract

The invention discloses a recombinant human fibroblast growth factor-9 protein drug freeze-dried preparation and application thereof. The invention provides a freeze-dried recombinant human FGF-9 protein pharmaceutical preparation which can effectively protect the stability of protein and treat liver injury, and particularly can repair and protect acute liver injury. Wide application prospects are realized.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and more particularly, the invention relates to a pharmaceutical freeze-dried preparation of recombinant human fibroblast growth factor-9 protein and its application. Background technique [0002] Acute liver injury is mainly a short-term sudden abnormal liver function caused by a variety of reasons, including viral infection, drug abuse, food poisoning, excessive alcohol intake, and radiation damage. The clinical incidence is increasing year by year. However, there is currently a lack of clinical therapeutic methods and drugs that can effectively stimulate liver function, protect and repair damaged liver cells, making liver disease the disease with the highest mortality rate in the world. [0003] Fibroblast growth factor (FGF) signaling plays an important role in regulating a variety of cellular functions including cell proliferation, survival, differentiation and migration. As a me...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61K9/19A61K47/10A61K47/18A61K47/22A61K47/26A61P1/16
CPCA61K38/1825A61K9/19A61K9/0019A61K47/26A61K47/10A61K47/18A61K47/22A61P1/16
Inventor 田海山张宏宇李傲黄麦李校堃
Owner 温州医科大学慈溪生物医药研究院
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