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Stabilizer for recombinant alpha-interferon liquid

A liquid stabilizer, interferon technology, applied in the direction of interferon, cytokine/lymphokine/interferon, specific peptide, etc., can solve the problem of the high price of human albumin, the increase of the cost of interferon products, the carrying of human albumin virus and other problems, to achieve the effect of obvious protection effect, lightening economic burden and low production cost

Inactive Publication Date: 2005-05-18
CHANGCHUN CHANGSHENG GENE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, human serum albumin is often used as a stabilizer for interferon. Due to the high price of human serum albumin, the cost of interferon products is increased, which brings a great economic burden to patients; in addition, human serum albumin has the potential risk of carrying viruses. susceptible to viral infections in patients
The applicant disclosed in Chinese patent 00110069.6 a protective agent using dextran as a freeze-dried dosage form of recombinant α-interferon, but as a stabilizer for a liquid dosage form, its validity period is too short (maintained at 4°C for 1 year), so the protective agent Not suitable as a protective agent for recombinant interferon-alpha in liquid dosage form

Method used

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  • Stabilizer for recombinant alpha-interferon liquid
  • Stabilizer for recombinant alpha-interferon liquid
  • Stabilizer for recombinant alpha-interferon liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Take gelatin, sucrose, polyethylene glycol, and glycine, and prepare them with 0.85% normal saline, wherein the gelatin, sucrose, polyethylene glycol, and normal saline solutions are sterilized by autoclaving, and the glycine solution is sterilized by filtration to prepare 2- No. 5 stabilizer, each concentration is as follows, No. 1 stabilizer is human serum albumin, as a control group, each sample contains recombinant α-type interferon 1-10 million IU / ml, fully mixed, sterilized and filtered, and packaged The amount is 1ml / branch.

[0011] The following is the stability of the interferon injection with the above-mentioned stabilizer and human albumin as a stabilizer under different conditions: (wherein the interferon titer is within 80-150% of the labeled amount, which means that the interferon activity has not decreased. )

[0012] No. 1 stabilizer: 1% human serum albumin, control group.

[0013] No. 2 stabilizer: 0.4% gelatin + 3% sucrose

[0014] No. 3 stabilizer...

Embodiment 2

[0025] Experimental results on gelatin and different disaccharide compositions.

[0026] No. 2-1: 0.5% gelatin + 2% sucrose

[0027] Size 2-2: 0.5% gelatin + 2% lactose

[0028] No. 2-3: 0.5% gelatin + 2% trehalose

[0029] Repeat above-mentioned process step, result is as follows:

[0030] Table 4: Stability of accelerated test interferon at 40°C (containing interferon 5 million IU / ml)

[0031]

Embodiment 3

[0033] Experimental results of gelatin and disaccharide compositions with different amino acids.

[0034] No. 4-1: 0.4% gelatin + 2% lactose + 0.5% glycine

[0035] No. 4-2: 0.4% gelatin + 2% lactose + 0.5% arginine

[0036] No. 4-3: 0.4% gelatin + 2% lactose + 0.5% lysine

[0037] Table 5: Stability of accelerated test interferon at 40°C (containing interferon 3 million IU / ml)

[0038]

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PUM

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Abstract

The present invention discloses a recombinant alpha interferon liquid stabilizing agent which is made by using geltin and diose as stabilizing agent of recombinant alpha interferon liquid drug-form, adding geltin and diose solution to interferon stoste, mixing evently, after degerming and filtering, packing and storing. Wherein, interferon titer is 100-1000 ten thousand IU / ml, gelatin concentration is 0.05-2.5%. The invented stabilizing agent is a non human blood product, non-toxic, harmless, low at production cost, remarkable protection effect, long effective period, avoiding potential risk for carrying virus using human serum albumin, and saving freezing process of the product. It can be used for preparing good-quality and low-price pollution-free "green" interferon injecta, reducing patient' financial burden.

Description

Technical field: [0001] The invention discloses a recombinant α-type interferon liquid stabilizer, which belongs to the protection of biological products [0002] technology field. Background technique: [0003] Interferon is a group of proteins with a wide range of biological activities that exist in the body, and has various functions such as anti-virus, anti-tumor, and regulation of the body's immune function. At present, it mainly treats chronic viral hepatitis, tumor and other viral infectious diseases. Interferon needs a stabilizer to protect its activity, otherwise it will be inactivated soon. At present, human serum albumin is often used as a stabilizer for interferon. Due to the high price of human serum albumin, the cost of interferon products is increased, which brings a great economic burden to patients; in addition, human serum albumin has the potential risk of carrying viruses. It is easy to cause viral infection to patients. The applicant disclosed in Chin...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/21A61K47/26A61K47/30A61K47/42C07K14/56
Inventor 张淑子董义兰杨美华田清影魏丽娟
Owner CHANGCHUN CHANGSHENG GENE PHARM CO LTD
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