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Stable recombination human alpha interferon liquid preparation and productive process thereof

A liquid preparation, alpha interferon technology, applied in the field of recombinant human alpha interferon liquid preparation, can solve the problems of unsatisfactory protective agent and thickener, affecting drug use, unfavorable preservation, etc., achieving high clinical application value and reliable curative effect , the effect of prolonging the adhesion time

Inactive Publication Date: 2003-10-22
CHANGCHUN CHANGSHENG GENE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although liquid preparations such as α-interferon nasal drops and eye drops have been put on the market, their protective agents and thickeners are not ideal, and

Method used

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  • Stable recombination human alpha interferon liquid preparation and productive process thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0023] Example 1

[0024] formula:

[0025] Recombinant human α2a interferon 3 million IU / ml.

[0026] Sodium chloride 0.85g

[0027] Methylparaben 0.03g

[0028] Propylparaben 0.02g

[0029] Gelatin 0.5g

[0030] Sodium Hyaluronate 0.02g

[0031] EDTA-Na 0.005g

[0032] Tween-80 1ml

[0033] Human Albumin 20% 5ml

[0034] Add water for injection to 100ml

[0035] Preparation Process:

[0036] 1. Preparation:

[0037] Solution A: Take sodium chloride, methylparaben, propylparaben, EDTA-Na, and Tween-80 according to the formula, put them in a container, add 70ml of water for injection, autoclave at 121°C for 30 minutes, and set aside.

[0038] Solution B: Slowly add the prescribed amount of sodium hyaluronate into 10ml of cooled water for injection, shake the container while adding, and let it stand overnight to fully dissolve.

[0039] Solution C: Add the gelatin in the prescribed amount into a container with accurate scale, add 15ml of water for injection to fully...

Example Embodiment

[0042] Example 2

[0043] formula:

[0044] Recombinant human α2a interferon 300IU / ml.

[0045] Sodium chloride 0.85g

[0046] Methylparaben 0.03g

[0047] Propylparaben 0.02g

[0048] Gelatin 0.5g

[0049] EDTA-Na 0.005g

[0050] Human Albumin 20% 5ml

[0051] Add water for injection 100ml

[0052] Preparation Process:

[0053] 1. Preparation:

[0054] Liquid A: Take sodium chloride, methylparaben, propylparaben, and EDTA-Na according to the formula, put them in a container, add 70ml of water for injection, autoclave at 121°C for 30 minutes, and set aside.

[0055] Liquid B: Add the gelatin in the prescribed amount into a container with accurate scale, add 15ml of water for injection to fully swell, autoclave at 121°C for 30 minutes, and set aside.

[0056] 2. Preparation of alpha interferon liquid preparation:

[0057] Mix the alpha interferon stock solution, human serum albumin, and the above-prepared liquid A, then sterilize and filter it into liquid B with a 0....

Example Embodiment

[0058] Example 3

[0059] formula:

[0060] Recombinant human α2a interferon 100IU / ml.

[0061] Sodium chloride 0.85g

[0062] Methylparaben 0.03g

[0063] Propylparaben 0.02g

[0064] Gelatin 0.5g

[0065] Sodium Hyaluronate 0.02g

[0066] Human Albumin 20% 5ml

[0067] Add water for injection to 100ml

[0068] 1. Preparation:

[0069] Liquid A: Take sodium chloride, methylparaben, and propylparaben according to the formula, put it in a container, add 70ml of water for injection, autoclave at 121°C for 30 minutes, and set aside.

[0070] Solution B: Slowly add the prescribed amount of sodium hyaluronate into 10ml of cooled water for injection, shake the container while adding, and let it stand overnight to fully dissolve.

[0071] Solution C: Add the gelatin in the prescribed amount into a container with accurate scale, add 15ml of water for injection to fully swell, and then autoclave at 121°C for 30 minutes, and set aside.

[0072] 2. Preparation of alpha interferon...

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Abstract

The present invention provides a stable recombinant human alpha interferon liquid preparation and its production process. It is made from interferon, human serum albumin, moisture-holding lubricant, thicking agent, isotonic regulating agent sodium chloride, EDTA-Na 0-0.05% and Tween-80 0.1-1% according to a certain proportion, it can prolong effective time of liquid interferon to above two years. It can be made into eye drops, nose drops and spray, said invention has good biological compatibility and stability, and has good moistening and humidity-holding action, and its preparation process is simple, its therapeutic effect is reliable and it has high clinical application value.

Description

Technical field: [0001] The invention provides a stable recombinant human alpha interferon liquid preparation and a production process. The stable liquid preparation also contains moisturizing lubricants, protective agents, thickeners, preservatives and stabilizers in addition to recombinant human alpha interferon , belongs to the technical field of interferon dosage form production. Background technique: [0002] Alpha interferon liquid preparation has preventive effect on SARS virus, influenza virus and rhinovirus, and can be used for nasal mucosa, eye mucosa, oral mucosa and sublingual spray or drop administration. Although liquid preparations such as α-interferon nasal drops and eye drops have been put on the market, their protective agents and thickeners are not ideal, and they all have the problem of short validity period. The storage period is only about one year, which is not conducive to preservation and affects use of the drug. Invention content: [0003] The i...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61K9/72A61K38/21A61K38/38A61P11/02A61P27/02A61P31/12A61P31/14
Inventor 章春宇李英黄宇董义兰
Owner CHANGCHUN CHANGSHENG GENE PHARM CO LTD
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