Recombinant human serum albumin-interferon alpha fusion protein water solution and preparation method thereof

A technology of human serum albumin and interferon alpha, which is applied in the field of aqueous solution of recombinant human serum albumin-interferon alpha fusion protein, and can solve the problem that the stability of the preparation needs to be improved.

Active Publication Date: 2013-12-11
QILU PHARMA CO LTD
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Problems solved by technology

But the stability of the preparation prepared according to the disclosed technical scheme of these two patent applications still needs to be improved

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  • Recombinant human serum albumin-interferon alpha fusion protein water solution and preparation method thereof
  • Recombinant human serum albumin-interferon alpha fusion protein water solution and preparation method thereof
  • Recombinant human serum albumin-interferon alpha fusion protein water solution and preparation method thereof

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Embodiment Construction

[0009] The technical scheme adopted in the present invention is:

[0010] A stable recombinant human serum albumin-interferon α fusion protein solution, which comprises recombinant human serum albumin-interferon α fusion protein and pharmaceutically acceptable stability auxiliary materials dissolved in a pharmaceutically acceptable buffer, It is characterized in that the pharmaceutically acceptable stable auxiliary material is arginine with a concentration of 5-30 g / L. Preferably, the concentration of the arginine is 10-25 g / L.

[0011] The concentration of the recombinant human serum albumin-interferon alpha fusion protein is 0.2-2 g / L.

[0012] The recombinant human serum albumin-interferon α fusion protein is selected from recombinant human serum albumin-interferon α2a fusion protein, recombinant human serum albumin-interferon α1b fusion protein, recombinant human serum albumin-interferon α2b fusion protein Protein or recombinant human serum albumin-interferon αcon fusion...

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Abstract

The invention relates to a stable recombinant human serum albumin-interferon alpha fusion protein water solution, belonging to the technical field of biological agents. The stable recombinant human serum albumin-interferon alpha fusion protein water solution is prepared by dissolving a recombinant human serum albumin-interferon alpha fusion protein and a pharmaceutically acceptable stability adjuvant in a pharmaceutically acceptable buffer solution. The invention is characterized in that the pharmaceutically acceptable stability adjuvant is arginine, and the concentration is 5-30 g / L. The recombinant human serum albumin-interferon alpha fusion protein water solution provided by the invention can sufficiently prevent the recombinant fusion protein from aggregation, degradation, oxidation, denaturization or the like, thereby keeping the biological activity of the recombinant fusion protein; and the recombinant human serum albumin-interferon alpha fusion protein water solution is suitable for clinical application.

Description

technical field [0001] The invention relates to a stable aqueous solution of recombinant human serum albumin-interferon alpha fusion protein, which belongs to the technical field of biological preparations. Background technique [0002] Interferons belong to the protein family of cytokines and are naturally present in the human body. Cytokines control cell growth, activation, migration and senescence. Interferon α is also a cytokine, but the exact mechanism of action of interferon α (IFNα) is not very clear. Studies have shown that IFNα has antiviral activity such as the treatment of hepatitis C, as well as immune regulation and direct effects on specific cancers. Antitumor effect. IFNα has become one of the most widely used drugs in clinical practice, and can treat human viral hepatitis (type B and type C), tumors and other related diseases such as viral infections. However, the molecular weight of IFNα is about 19KD. As a small molecular protein, IFNα can be cleared fro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61K47/48A61K47/18A61K47/34A61K9/08A61P1/16A61P31/14A61P31/20A61P35/00A61K47/26A61K47/64
Inventor 董婷张乐王克波孙丽霞秦素娟
Owner QILU PHARMA CO LTD
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