Interferon composition as well as preparation method and application thereof

A composition and technology of interferon, applied in the field of biomedicine, can solve problems such as high difficulty in preservation, high cost of human serum albumin, strong immunogenicity, etc., to avoid intolerance, high difficulty in preservation, and high difficulty in preparation Effect

Pending Publication Date: 2021-12-17
SHENZHEN KEXING PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most interferons have short half-life and strong immunogenicity in application
[0003] Currently commercially available human interferon products mostly use human serum albumin as a protective agent to maintain product stability, but human serum albumin, as a blood product, has the risk of introducing viruses and other pathogens, and human serum albumin may also interact with protein Combination of drugs to form macromolecular substances, causing unnecessary antigen-antibody reactions, poor safety
In addition, the product contains human serum albumin, which will seriously affect the analysis of structural changes in the stability of human interferon during storage; moreover, human serum albumin is expensive and difficult to store, which is not conducive to industrial production

Method used

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  • Interferon composition as well as preparation method and application thereof
  • Interferon composition as well as preparation method and application thereof
  • Interferon composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Embodiment 1: the preparation of interferon composition

[0061] Prescription: as shown in Table 1.

[0062] Table 1: Prescriptions for Interferon Compositions

[0063] components Feeding amount human interferon alpha 1b 50mg hyaluronic acid 2.0g Disodium hydrogen phosphate dodecahydrate 0.3g Sodium dihydrogen phosphate monohydrate 0.1g Sodium chloride 7.0g Tween 80 0.1g Edetate Disodium 0.2g Water for Injection Add water for injection to make the composition volume 1000mL

[0064] Preparation process: Take hyaluronic acid, add water for injection, heat and stir until completely dissolved, cool to room temperature, add disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, Tween 80 and disodium edetate , stirred to dissolve, then added human interferon α1b, stirred evenly, sterilized and filtered to obtain an interferon composition.

Embodiment 2

[0065] Embodiment 2: the preparation of interferon composition

[0066] Prescription: as shown in Table 2.

[0067] Table 2: Prescriptions for Interferon Compositions

[0068]

[0069]

[0070] Preparation process: Take polyvinyl alcohol, add water for injection, heat and stir until completely dissolved, cool to room temperature, add disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, Tween 80 and disodium edetate , stirred to dissolve, then added human interferon α1b, stirred evenly, sterilized and filtered to obtain an interferon composition.

Embodiment 3

[0071] Embodiment 3: the preparation of interferon composition

[0072] Prescription: as shown in Table 3.

[0073] Table 3: Prescriptions for Interferon Compositions

[0074] components Feeding amount human interferon alpha 1b 50mg hyaluronic acid 2.0g Trehalose 10.0g Disodium hydrogen phosphate dodecahydrate 0.4g Sodium dihydrogen phosphate monohydrate 0.1g Sodium chloride 7.0g Tween 80 0.1g Edetate Disodium 0.2g Water for Injection Add water for injection to make the composition volume 1000mL

[0075] Preparation process: Take hyaluronic acid, add water for injection, heat and stir until completely dissolved, cool to room temperature, add trehalose, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, Tween 80 and editidine disodium acid, stirred and dissolved, then added human interferon α1b, stirred evenly, sterilized and filtered to obtain the interfero...

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PUM

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Abstract

The invention relates to an interferon composition as well as a preparation method and application thereof, and belongs to the field of biological medicines. The composition comprises interferon, a protective agent, buffer salt and water. The composition is safe, environment-friendly, low in cost and good in stability. The preparation method is simple to operate and beneficial to industrial production.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to an interferon composition and its preparation method and application. Background technique [0002] Human interferon (IFN) is a cytokine protein drug produced by activated fibroblasts and certain epithelial cells, and has antiviral infection, antitumor and strong immune regulation effects. Most of the interferons in the application have short half-lives and strong immunogenicity. [0003] Currently commercially available human interferon products mostly use human serum albumin as a protective agent to maintain product stability, but human serum albumin, as a blood product, has the risk of introducing viruses and other pathogens, and human serum albumin may also interact with protein Drugs are combined to form macromolecular substances, causing unnecessary antigen-antibody reactions, and the safety is poor. In addition, the product contains human albumin, which will seriously affect t...

Claims

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Application Information

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IPC IPC(8): A61K38/21A61K47/02A61K47/26A61K47/32A61K47/36A61P31/12A61P35/00A61P37/02A61P35/02A61P31/18A61P31/20A61P31/22A61P31/14
CPCA61K38/21A61K38/212A61K38/215A61K38/217A61K47/36A61K47/32A61K47/26A61K47/02A61P31/12A61P35/00A61P37/02A61P35/02A61P31/18A61P31/20A61P31/22A61P31/14A61K2300/00Y02A50/30
Inventor 曾荣贵杨经安黎鼎英鄢成伟秦锁富
Owner SHENZHEN KEXING PHARMA CO LTD
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