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Recombination human interferon injection

A technology of recombinant human interferon and injection, applied in the field of interferon, to solve the problem of visible foreign matter, good stability and avoid potential danger

Active Publication Date: 2010-03-24
BEIJING KAWIN TECH SHARE HLDG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Yet, the method that uses succinylated gelatin as interferon injection stabilizer has not been reported yet

Method used

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  • Recombination human interferon injection
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Experimental program
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Effect test

Embodiment 1

[0020] Embodiment 1 Recombinant human interferon injection prescription and preparation method thereof of the present invention

[0021] 1. Prescription 1:

[0022] Recombinant human interferon α2b 1.5×10 9 (IU), 4% succinylated gelatin 40ml, Tween 800.0090mg, sodium chloride 3.0g, water for injection to the volume of 150ml.

[0023] 2. Preparation method:

[0024] (1) prepare 0.9% sodium chloride sterilized aqueous solution;

[0025] (2) Tween 80 is weighed according to the aforementioned prescription quantity, and added to 0.9% sodium chloride sterilized aqueous solution of 50% of the full volume;

[0026] (3) Measure the succinylated gelatin sodium chloride injection of prescription quantity, add in step (2) gained solution and mix;

[0027] (4) Add the recombinant human interferon α2b of the prescription amount into the solution obtained in step (3), and mix well;

[0028] (5) adjust the pH value to 5.0-7.0 with 0.1mol / L hydrochloric acid solution;

[0029] (6) Dilut...

Embodiment 2

[0030] Embodiment 2 Recombinant human interferon injection prescription and preparation method thereof of the present invention

[0031] 1. Prescription 2:

[0032] Recombinant human interferon α1b 1.5×10 9 (IU), 60ml of 4% succinylated gelatin, 800.0090mg of Tween, 3.0g of sodium chloride, and dilute to 150ml with water for injection.

[0033] 2. Preparation method:

[0034] (1) prepare 0.9% sodium chloride sterilized aqueous solution;

[0035] (2) Tween 80 is weighed according to the aforementioned prescription quantity, and added to 0.9% sodium chloride sterilized aqueous solution of 50% of the full volume;

[0036] (3) Measure the succinylated gelatin sodium chloride injection of prescription quantity, add in step (2) gained solution and mix;

[0037] (4) Measure the prescription amount of recombinant human interferon α1b and add it to the solution obtained in step (3), and mix well;

[0038] (5) adjust the pH value to 5.0-7.0 with 0.1mol / L hydrochloric acid solution;...

Embodiment 3

[0040] Embodiment 3 Recombinant human interferon injection prescription of the present invention and preparation method thereof

[0041] 1. Prescription 3:

[0042] Recombinant human interferon α2a 1.5×10 9 (IU), 80ml of 4% succinylated gelatin, 800.0090mg of Tween, 3.0g of sodium chloride, and dilute to 150ml with water for injection.

[0043] 2. Preparation method:

[0044] (1) prepare 0.9% sodium chloride sterilized aqueous solution;

[0045] (2) Tween 80 is weighed according to the aforementioned prescription quantity, and added to 0.9% sodium chloride sterilized aqueous solution of 50% of the full volume;

[0046] (3) Measure the succinylated gelatin sodium chloride injection of prescription quantity, add in step (2) gained solution and mix;

[0047] (4) Add the recombinant human interferon α2a of the prescription amount into the solution obtained in step (3), and mix well;

[0048] (5) adjust the pH value to 5.0-7.0 with 0.1mol / L hydrochloric acid solution;

[0049...

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Abstract

The present invention provides a recombined human interferon injection. Succinylated gelatin and tween 80 replace human serum albumin to be used as stabilizing agent, which not only effectively avoidsthe potential danger caused by using blood product but also can achieve the same or better stability effect and at the same time does not influence the activity of interferon. Besides, the technologyof the present invention is adopted to radically solve the problem of visual foreign body caused by the human serum albumin and is fit for the industrialization mass production.

Description

technical field [0001] The invention relates to the field of interferon, in particular to a recombinant human interferon injection and a preparation method thereof. Background technique [0002] Recombinant human interferon has broad-spectrum anti-virus, anti-tumor, inhibition of cell proliferation and improvement of immune function, and is the first choice for the treatment of acute and chronic viral hepatitis. At present, the most widely used dosage forms of recombinant human interferon are freeze-dried powder injections and small-volume injections. Among them, injections are more convenient to use, but their prescriptions are required to protect the long-term stability of interferon molecules in aqueous solution. Human blood white is usually used. Protein acts as a stabilizer for interferon. However, human albumin has its own defects. As a blood product, patients are at risk of contracting blood diseases when used, and the export threshold is high. Therefore, it is neces...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K38/21A61K47/36A61P31/12A61P35/00A61P37/00
Inventor 张春丽周德胜吉春
Owner BEIJING KAWIN TECH SHARE HLDG
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