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Stable aqueous solution of pegylation interferon

A technology of PEGylation and mercaptopolyethylene glycol, which is applied in the field of stable aqueous solution of PEGylated interferon, and can solve problems such as difficult preparation, storage and transportation

Active Publication Date: 2013-02-13
BEIJING TRI PRIME GENE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The purpose of the present invention is to provide a stable aqueous solution of pegylated interferon, which contains Tween-80 less than the conventional dosage and does not contain albumin, so as to solve the problem of protein drug aqueous solution existing in the aqueous solution state. The dosage form is not easy to prepare, store and transport, and it is necessary to add high-concentration Tween and other surfactants and albumin during preparation.

Method used

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  • Stable aqueous solution of pegylation interferon
  • Stable aqueous solution of pegylation interferon
  • Stable aqueous solution of pegylation interferon

Examples

Experimental program
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Effect test

Embodiment 1

[0018] Embodiment 1: the preparation of different formula pegylated interferon aqueous solution

[0019] Prepare different formulations of pegylated interferon aqueous solutions according to the preparation method in Table 1 below, wherein "pegylated interferon 1" consists of a single-chain mercapto polyethylene glycol modifier mPEG-MAL with a molecular weight of 20KDa and SEQ ID No. The interferon connection of the amino acid sequence shown in 1 is obtained, and its preparation method and other information are disclosed in Chinese patent application 200780034504.3 (corresponding to PCT application PCT / CN2007 / 003711) (corresponding to mPEG(20KD)-MIFN in this patent application Cys86 ); "PEGylated interferon 2" is obtained by linking the double-chain thiol polyethylene glycol modifier mPEG2-MAL with a molecular weight of 40KDa and the interferon of the amino acid sequence shown in SEQ ID No.1, also in Chinese patent application 200780034504.3 Information such as its preparation...

Embodiment 2

[0025] Embodiment 2: the accelerated stability test of different formula pegylated interferon aqueous solution

[0026] The pegylated interferon aqueous solution of different formulations prepared by the method of Example 1 was placed in 37 ℃ of water solution for 3 months. The activity of pegylated interferon was measured by "assay for pegylated interferon activity", and the results are shown in Table 2 below.

[0027] The accelerated stability test activity detection result of different formula pegylated interferon aqueous solution of table 2

[0028]

[0029]

[0030]

[0031]

[0032]

[0033]

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Abstract

The invention belongs to the field of preparations of protein medicaments, and relates to a stable aqueous solution of a pegylation interferon. The aqueous solution is characterized by not containing any albumin but containing: (1) an effective treatment amount of a pegylation interferon, (2) 2-200 mmol / L of an acetic acid-sodium acetate buffer solution of which the pH is 5.5-6.0, (3) Tween 80 of which the concentration (v / v) is one ten thousandth to five ten thousands, and (4) 0.4-0.8 percent (m / v) of NaCl. The pegylation interferon stable aqueous solution contains surfactant substances such as low-concentration Tween and the like, does not contain any albumin, but basically has the same stability as those of surfactant substances such as high-concentration Tween and the like as well as aqueous solutions of high-concentration albumins.

Description

technical field [0001] The present invention generally relates to a stable aqueous solution of pegylated interferon, in particular to a stable aqueous solution of pegylated interferon obtained after modifying the interferon with a mercapto polyethylene glycol modifier. Background technique [0002] Aqueous solution dosage forms are the most common dosage forms of protein drugs, such as injections, eye drops, sprays, etc. However, since the protein is very unstable in aqueous solution, it is easy to be chemically or biologically degraded or change the configuration and conformation, thereby reducing or losing the biological activity. When used, it is dissolved in physiological saline to form an aqueous solution. However, redissolving the lyophilized protein aqueous solution during use will prolong the patient’s medication time on the one hand, and on the other hand will cause drug administration due to incomplete dissolution, inaccurate dosage of solvent saline, inaccurate a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/48A61K38/21A61K9/08
Inventor 周敏毅刘金毅程永庆
Owner BEIJING TRI PRIME GENE PHARMA CO LTD