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A method for detecting bacterial endotoxin content in recombinant porcine interferon α1 freeze-dried powder injection

A technology of bacterial endotoxin and freeze-dried powder injection, which is applied in the field of microorganisms to achieve the effects of low detection cost, easy operation, and accurate and reliable detection results

Active Publication Date: 2016-01-20
王明丽 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current bacterial endotoxin test method for veterinary biological products is still the traditional rabbit pyrogen test, so it is of great significance to establish a new detection method for bacterial endotoxin content in veterinary biological products

Method used

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  • A method for detecting bacterial endotoxin content in recombinant porcine interferon α1 freeze-dried powder injection
  • A method for detecting bacterial endotoxin content in recombinant porcine interferon α1 freeze-dried powder injection
  • A method for detecting bacterial endotoxin content in recombinant porcine interferon α1 freeze-dried powder injection

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Experimental program
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Effect test

Embodiment 1

[0013] 1. Reagents

[0014] Test product: Recombinant porcine interferon α1 freeze-dried powder injection (batch number 20121116, potency 1.0×10 6 IU, endotoxin content is 25EU)

[0015] Bacterial endotoxin test water: sterile water for injection with endotoxin content less than 0.015EU / ml and no interference to endotoxin test

[0016] National Standard Bacterial Endotoxin: Purchased from China National Institutes for Food and Drug Control, 10,000 EU each.

[0017] Limulus reagent: purchased from Xiamen Limulus Reagent Factory, 0.1ml / tube (λ=0.25EU / ml)

[0018] 2. Instruments and equipment

[0019] Vortex mixer, parafilm, test tube (10×75mm), pipette, tweezers (metal), metal box.

[0020] All glassware used in the experiment is generally soaked in lotion, then taken out and rinsed with tap water and purified water in sequence (purified water can be used for soaking).

[0021] The utensils used in the test need to be dry-baked at 250°C for more than 30 minutes before use t...

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Abstract

The invention discloses a method for detection of the content of bacterial endotoxin in a recombinant porcine interferon alpha 1 freeze-dried powder injection. A modified limulus amebocyte lysate test method is used, 2ml of water used for bacterial endotoxin inspection is used for dissolving the recombinant porcine interferon alpha 1 freeze-dried powder injection, and limulus lysate test interfering factors are removed by 10min of boiling at 100 DEG C; in the case of no exceeding of the maximum effective multiples, the water used for the bacterial endotoxin inspection is used for stepwise dilution of recombinant porcine interferon alpha 1 protein processed by boiling; first, the contents of the bacterial endotoxin with various dilution concentrations are detected, then an interference test is started from lowest dilutability with a negative reaction result, and a lowest concentration for forming a gel with the limulus test in the circumstance of no interference is found, so that the specific content of the bacterial endotoxin in the recombinant porcine interferon alpha 1 freeze-dried powder injection can be determined. The method provides a bacterial endotoxin detection method for the production and application of the recombinant porcine interferon alpha 1 freeze-dried powder injection.

Description

technical field [0001] The invention belongs to the field of microorganisms, and relates to a method for detecting bacterial endotoxin content of biological products, in particular to a method for detecting bacterial endotoxin content in recombinant porcine interferon α1 freeze-dried powder injection. Background technique [0002] Interferon is currently recognized as an effective antiviral drug with good safety performance and good antiviral and immune regulation functions. It is one of the most widely used biological agents today. The earliest animal interferon used in veterinary clinics was porcine leukocyte interferon, but the expression level of this kind of interferon is low, and it needs to be obtained by biochemical separation, which is expensive and is not conducive to large-scale production. Our laboratory has obtained a recombinant porcine interferon α (preparation method of recombinant porcine α interferon, patent number 2008100201804) by using genetic engineerin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/68
CPCG01N33/56911G01N33/579G01N33/6866G01N2333/56
Inventor 王明丽赵俊叶靓周炜
Owner 王明丽
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