PEG-IFN omega conjugate and preparation technique thereof

A technology of recombinant human interferon and polyethylene glycol, applied in the direction of drug combination, digestive system, medical preparations of non-active ingredients, etc., can solve the problems of short half-life, poor stability, etc., and achieve improved uniformity, easy acceptance, The effect of easy purification

Inactive Publication Date: 2009-07-29
BEIJING KAIZHENG BIOTECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the biggest problem with protein drugs is that they have limitations such as poor stability, short half-life, and possible immunogenicity.

Method used

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  • PEG-IFN omega conjugate and preparation technique thereof
  • PEG-IFN omega conjugate and preparation technique thereof
  • PEG-IFN omega conjugate and preparation technique thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The purity of the recombinant human interferon ω used in this example is greater than 98% and maintains high biological activity; the recombinant human interferon is dissolved in 100 mM acetic acid-sodium acetate buffer (pH 4.0), and press Add monomethoxy polyethylene glycol propionaldehyde (mPEG-propionaldehyde, mPEG-ALD) in the molar ratio of recombinant human interferon ω to polyethylene glycol propionaldehyde 1:1, stir to dissolve, then add NaCNBH3, and react at room temperature 48 hours.

Embodiment 2

[0060] The purity of the recombinant human interferon ω used in this example is greater than 98% and maintains high biological activity; the recombinant human interferon is dissolved in 100 mM acetic acid-sodium acetate buffer (pH 4.0), and press Add monomethoxy polyethylene glycol propionaldehyde (mPEG-propionaldehyde, mPEG-ALD) in the ratio of 1:3 molar ratio of recombinant human interferon ω to polyethylene glycol propionaldehyde, stir to dissolve, then add NaCNBH3, and react at room temperature 24 hours.

Embodiment 3

[0062] The purity of the recombinant human interferon ω used in this example is greater than 98% and maintains high biological activity; the recombinant human interferon is dissolved in 100 mM acetic acid-sodium acetate buffer (pH 4.0), and press Add monomethoxy polyethylene glycol propionaldehyde (mPEG-propionaldehyde, mPEG-ALD) in the molar ratio of recombinant human interferon ω to polyethylene glycol propionaldehyde 1:5, stir to dissolve, then add NaCNBH3, and react at room temperature 12 hours.

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Abstract

The invention discloses a pegylation recombinant interferon omega conjugate and a preparation process thereof. Compared with an unmodified interferon omega, the pegylation recombinant interferon omega conjugate has longer half-life in a human body, can obviously reduce the number of medication, reduce toxic and side effect, is particularly suitable for treating chronic viral infection sensitive to the interferon omega, and has wide application prospect clinically.

Description

Technical field [0001] It relates to a pharmaceutical preparation for treating viral infections sensitive to interferon ω, in particular to a pegylated recombinant human interferon conjugate which can significantly reduce the number of medications and has a long-acting effect and its preparation process. Background technique [0002] Interferon is a group of active proteins (mainly glycoproteins) with multiple functions, and is a cytokine produced by monocytes and lymphocytes. They have broad-spectrum antiviral activity on the same cells, affecting cell growth and differentiation, and regulating immune function. According to the amino acid structure, antigenicity and cell source of interferon protein, it can be divided into: IFN-α, IFN-β, IFN-γ. IFN-ω belongs to the IFN-α family, and its structure and size are slightly different from other IFN-α, but the antigenicity is quite different. Since the 1980s, many studies have shown that in addition to anti-virus and immune regulation ...

Claims

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Application Information

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IPC IPC(8): A61K47/48A61P1/16A61K38/21A61K47/60
Inventor 王玉民严玖凤李晋峰陈婷刘佳申晓阳邢娜
Owner BEIJING KAIZHENG BIOTECH DEV
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