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Method for detection and evaluation of biological functions of molecule and medicine and use thereof

A molecular and drug technology, applied in the direction of medical preparations containing active ingredients, drug combinations, and pharmaceutical formulas, can solve the problems of lagging application of HBV transgenic mice, and achieve the effect of simple operation and good repeatability of results

Inactive Publication Date: 2014-08-13
FUDAN UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is worth mentioning that due to differences in gene integration sites and expression in transgenic mice, the application of HBV transgenic mice in molecular evaluation and drug development lags behind

Method used

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  • Method for detection and evaluation of biological functions of molecule and medicine and use thereof
  • Method for detection and evaluation of biological functions of molecule and medicine and use thereof
  • Method for detection and evaluation of biological functions of molecule and medicine and use thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0044] Example 1: Ability of anti-HBV monoclonal antibody and HBIG to neutralize HbSAg in animals

[0045] Using the detection method established in the present invention, respectively detect the ability of anti-HBV monoclonal antibody and HBIG to neutralize HbSAg in animal body. HBIG is a human anti-hepatitis B virus globulin produced by Zhongsheng Group. The humanized anti-HBV monoclonal antibody was provided by the Institute of Viral Disease Prevention and Control, Chinese Center for Disease Control and Prevention.

[0046] The specific detection steps are:

[0047] (1) 7-8 week-old female C57BL / 6J-Tg(AlblHBV)44Bri / Jf4J mice stably expressing HbSAg were selected for the experiment.

[0048] (2) After grouping, 0.5 ml of experimental samples were injected intraperitoneally.

[0049] (3) Blood was collected from the venous plexus of the mouse frame at a specific time point. After the blood sample was allowed to stand at room temperature for 1 hour, it was centrifuged at a ...

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Abstract

The present invention relates to antibody engineering and anti-infection drug field, provides a method for detection and evaluation of biological functions of a molecule and a medicine and use thereof, and particularly relates to a method for detection of biological functions of (human) anti-human hepatitis B virus antibody. The method can effectively detect the level of the biological functions of the molecule, the medicine and the (human) anti-human hepatitis B virus antibody. According to the method, biological activity of a forerunner molecule and drug can be defined by detection of the ability of the to-be-detected forerunner molecule and drug to neutralize pathogene key molecules in animal body and the ability of the to-be-detected forerunner molecule and drug to break immune tolerance and reconstruct immune protection in the animal body. The method can be used for rapid detection of virus clearing ability and virus infection and pathogenesis control ability of antibodies and other anti-infection drugs. The method has the advantages of simple operation process and good the repeatability, and is a supplement to methods in the prior art for detection and evaluation of functionality of antiviral drugs, the method is established for providing a new choice for research and development of drugs of cell and animal infection model virus.

Description

technical field [0001] The invention relates to the fields of antibody engineering and anti-infection medicine, and relates to a method for detecting and evaluating molecular and drug biological functions and its application. It specifically relates to an effective method for detecting and evaluating the anti-infection ability of molecules and drugs in animals, and a group of molecules that can achieve one or more of the following functions in vivo: 1) neutralize key molecules of pathogens; 2) create key Molecular low-level window period; 3) Break immune tolerance and rebuild immune regulation. Background technique [0002] Human hepatitis B virus (human hepatitis B virus, HBV) infection is a global public health problem. According to the statistics of the World Health Organization (World Health Organization, WHO), more than 2 billion people have been infected with HBV worldwide. Among them, 350 million are suffering from chronic HBV infection (WHO, 2000). my country is a hi...

Claims

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Application Information

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IPC IPC(8): A61K49/00A61K45/00A61K39/42A61P31/00
Inventor 陈力闻玉梅李蒙
Owner FUDAN UNIV
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