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A kind of pegylated interferon injection and preparation method thereof

A technology of polyethylene glycol and interferon, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of infectious blood diseases, protein molecular changes, and easy oxidation, etc. Achieve the effect of improving safety and stability, reducing manufacturing cost and simple process

Active Publication Date: 2015-09-09
长春海伯尔生物技术有限责任公司
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  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are two forms of pegylated interferon preparations on the market, namely freeze-dried preparations and liquid preparations. Liquid preparations are more and more recognized by people because of their convenience and low cost. Dry preparations have higher requirements. The requirement is to protect the protein in an aqueous solution and maintain long-term stability. Human serum albumin is usually used as a stabilizer, but human serum albumin is expensive and has the potential risk of infection of blood diseases
Protein-free stabilizers are more and more widely used. In the prior art, benzyl alcohol Tween 80 system is used as a stabilizer component, but benzyl alcohol is easily oxidized under high temperature or light, and it is easy to cause changes in protein molecules and affect drug stability. sex
Moreover, according to clinical reports, benzyl alcohol has the risk of causing muscular gluteus contracture in children, increasing the risk of drug administration to patients

Method used

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  • A kind of pegylated interferon injection and preparation method thereof
  • A kind of pegylated interferon injection and preparation method thereof
  • A kind of pegylated interferon injection and preparation method thereof

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preparation example Construction

[0025] The present invention also provides a preparation method of pegylated interferon injection, such as figure 1 As shown, it includes the following steps:

[0026] Step 101: Prepare a dilution solution, perform moist heat sterilization at 121°C for 30 minutes, and cool to 2°C-8°C;

[0027] Step 102: adding the stock solution of pegylated interferon, Tween 80 and disodium edetate to the diluent and mixing to obtain a mixed solution;

[0028] Step 103: Filter the mixed solution through a 0.2 μm microporous membrane, and pack into different specifications of 0.25-1.0 ml / bottle to obtain the pegylated interferon injection.

[0029] In another preferred embodiment of the present invention, the content of the pegylated interferon is 180 μg / ml, and the content of the Tween 80 is 0.1-0.3 mg / ml. The content of disodium edetate is 1-2 mg / ml; the pegylated interferon injection also includes phosphate buffer, and the content of the phosphate buffer is 0.1M-0.3M.

[0030] Further, w...

Embodiment 1

[0033] The components of pegylated interferon α2b injection are: pegylated interferon α2b 180mg, Tween 80 100mg, disodium edetate 1g, disodium hydrogen phosphate 12.68g, sodium dihydrogen phosphate 3.43g , 4.89 g of sodium chloride, an appropriate amount of water for injection, and the total volume of the above components is 1000 ml.

[0034] The preparation method of pegylated interferon injection comprises the following steps:

[0035] Weigh 12.68 g of disodium hydrogen phosphate, 3.43 g of sodium dihydrogen phosphate, and 4.89 g of sodium chloride; Perform moist heat sterilization at 121°C for 30 minutes, and cool to 2°C-8°C to obtain a dilution;

[0036] Prepare a 1% Tween 80 solution: weigh 100 mg of Tween 80, add an appropriate amount of water for injection, and stir until the solution is evenly mixed;

[0037] Take the solution of pegylated interferon α2b, edetate disodium and the above 1% Tween 80 in the above prescription and add it to the diluent, then set the volu...

Embodiment 2

[0040]The components of peginterferon α2b injection are: peginterferon α2b 180mg, Tween 80 200mg, disodium edetate 1g, disodium hydrogen phosphate 12.68g, sodium dihydrogen phosphate 3.43g , 4.89 g of sodium chloride, an appropriate amount of water for injection, and the total volume of the above components is 1000 ml.

[0041] The preparation method of pegylated interferon injection comprises the following steps:

[0042] Weigh 12.68 g of disodium hydrogen phosphate, 3.43 g of sodium dihydrogen phosphate, and 4.89 g of sodium chloride, dissolve them with an appropriate amount of water for injection, add them to the above solution, and set the volume to the specified volume. The pH value is between 6.5-7.5. Then perform moist heat sterilization at 121°C for 30 minutes, and cool to 2°C-8°C to obtain a dilution;

[0043] Prepare a 1% Tween 80 solution: weigh 200 mg of Tween 80, add an appropriate amount of water for injection, and stir until the solution is evenly mixed;

[00...

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Abstract

The invention discloses a pegylated interferon injection and a preparation method thereof. The pegylated interferon injection comprises pegylated interferon and auxiliary materials and is characterized in that a stabilizer in the auxiliary materials is a combination of Tween-80 and sodium ethylenediamine tetracetic acid; the pegylated interferon is any one of pegylated interferon alpha 1b, pegylated interferon alpha 2a and pegylated interferon alpha 2b, and the stock solution purity of the pegylated interferon is more than or equal to 95 percent. The specific combination of the Tween-80 and the sodium ethylenediamine tetracetic acid is used as a protein stabilizer, the risk caused when human blood albumin is used as a stabilizer is effectively avoided, and the identical stable effect can be achieved; relative to a Tween-80 and benzyl alcohol stabilizer system, the specific combination of the Tween-80 and the sodium ethylenediamine tetracetic acid is safer and more stable, so that the safety and the stability of the injection are improved, the finished injection product can be subjected to detection and control in terms of protein purity and content, and the product quality is truly guaranteed. The preparation method is simple, raw materials and the auxiliary materials are well sourced, and the manufacturing cost of the pegylated interferon injection is reduced.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a pegylated interferon injection and a preparation method thereof. Background technique [0002] Interferon is currently a widely used therapeutic drug with significant clinical effects. It has broad-spectrum anti-virus, anti-tumor and immune regulation functions. It is an irreplaceable drug in the treatment of viral diseases, but ordinary interferon therapy has its own insurmountable Disadvantages, short half-life, its serum concentration is already very low 24 hours after injection. The dosing regimen is injected 3 times a week, which leads to large fluctuations in blood concentration. In recent years, PEGylation technology has effectively solved such defects of protein drugs. Pegylated interferon is a covalent combination of interferon and polyethylene glycol to improve the biological activity of interferon. The molecular weight of pegylated interferon is greatly increased...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/21A61K9/08A61K47/34A61K47/18A61P1/16A61P31/14A61P31/20A61P35/00A61P37/02
Inventor 刘芃实贺永山卡特琳娜·阿尔瓦斯杨春雨徐福平
Owner 长春海伯尔生物技术有限责任公司
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