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Immunogenic polysaccharide vaccine and identification method thereof

An immunogenic, polysaccharide technology, applied in the medical field, can solve the problems of excessive sample molecular weight, difficult to form a precipitation line, affecting the test effect, etc., and achieve the effect of high sensitivity and good specificity.

Inactive Publication Date: 2018-12-18
复星安特金(成都)生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this method, the concentration of antigen and antibody should not be too small. The dilution of the free diffusion process will cause the concentration to be too small to produce a precipitation line, and the sample molecular weight is too large to be conducive to diffusion and affect the test effect.
[0005] In the specific operation, the immunological double diffusion method needs to prepare the gel plate in advance, dilute the antigen and antibody to the appropriate concentration, add them to the corresponding wells respectively, diffuse horizontally at 37°C for 24 hours, soak for 30 minutes, stain for 30 minutes, and then decolorize to the background. Color, observation, the whole process takes about 2 days or even longer, and the way of free diffusion is used to contact the antigen and antibody. The molecular weight of the sample should not be too large, and the concentration should not be too low, otherwise it will be difficult to form a clear precipitation line, especially for For samples whose antigenicity is reduced due to a series of reactions in the preparation process, it is more difficult to achieve the appropriate antigen concentration required in the immunodiffusion method, which makes it difficult to implement the identification test

Method used

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  • Immunogenic polysaccharide vaccine and identification method thereof
  • Immunogenic polysaccharide vaccine and identification method thereof
  • Immunogenic polysaccharide vaccine and identification method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] The invention provides an immunogenic polysaccharide, the polysaccharide is identified through the turbidimetry of the immunization rate, and the turbidimetry of the immunization rate at least includes contacting the polysaccharide solution with the corresponding antibody to form an antigen-antibody complex, The value of the reaction rate of antigen-antibody complex was determined by nephelometric scattering.

[0065] In the further optimized technical scheme of the present invention, the immunogenic polysaccharides include capsular polysaccharides of any serogroup of Neisseria meningitidis, capsular polysaccharides of any serotype of Haemophilus influenzae, Vi polysaccharides of Salmonella typhi, Staphylococcus aureus Capsular polysaccharide of any serotype, capsular polysaccharide of any serotype of Cryptococcus, capsular polysaccharide of any serogroup of Streptococcus, capsular polysaccharide of any serogroup of Clostridium difficile, capsular polysaccharide of any ser...

Embodiment 2

[0080] The present invention provides a polysaccharide vaccine prepared from immunogenic polysaccharides. The polysaccharide vaccine is identified through the turbidimetry of the immune rate, and the immune rate turbidimetry at least includes contacting the polysaccharide vaccine with the corresponding antibody to form an antigen-antibody complex , and then the reaction rate value of the antigen-antibody complex was determined by immune rate scattering turbidimetry. In other words, polysaccharide vaccines are identified by using the rate unit value measured by the specific combination of antigen and antibody to form an antigen-antibody complex.

[0081] In the further optimized technical scheme of the present invention, the polysaccharide in the polysaccharide vaccine includes any serogroup capsular polysaccharide of Neisseria meningitidis, any serotype capsular polysaccharide of Haemophilus influenzae, Salmonella typhi Vi polysaccharide, Staphylococcus aureus Capsular polysac...

Embodiment 3

[0096] (1) Sample source Meningococcal serogroups A, C, Y, W135 capsular polysaccharides, Haemophilus influenzae serotype b capsular polysaccharides, and reference tetanus toxoid were purchased from NIBSC (National Institute for the Control of Biological Products, UK) , Meningococcal serogroups A, C, Y, W135 antiserum were purchased from BD Biological Company, and typhoid Vi polysaccharide antiserum was purchased from China National Institutes for Food and Drug Control.

[0097] (2) Prepare meningococcal serogroups A, C, Y, W135 capsular polysaccharides, group A meningococcal polysaccharide vaccines, group C meningococcal polysaccharide vaccines, group A Group C meningococcal polysaccharide vaccine, ACYW135 group meningococcal polysaccharide vaccine, typhoid Vi polysaccharide and its vaccine are prepared according to the method published in Chinese patent CN201110171746.5.

[0098] (3) According to the items and methods specified in the Pharmacopoeia of the People's Republic o...

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Abstract

The invention relates to an immunogenic polysaccharide, an identification method, a polysaccharide vaccine prepared by using the immunogenic polysaccharide, and an identification method of the vaccine. Every identification method at least comprises the following steps: a polysaccharide antigen is in contact with a corresponding antibody to form an antigen-antibody complex, and the reaction rate ofthe generation of the antigen-antibody complex is detected by the rate scattering immunoturbidimetric assay technology. The rate scattering immunoturbidimetric assay technology is a technical way established based on an immunochemical technology, can be used to measure the intensity change of scattered lights caused by particles suspended in a small cup, and allows the reaction rate value to beobtained in several tens of seconds. The reaction of the antigen and the antibody is carried out to form antigen-antibody complex aggregate particles, and the particle formation rate differs dependingon the concentration of the antigen or the antibody. The methods have the advantages of high specificity, high sensitivity, saving of the detection time, and facilitation of the detection of a low-concentration sample by direct contact of the antigen and the antibody, and can be used for identifying a stock solution and / or a semi-finished product and / or a finished product in the vaccine production process.

Description

technical field [0001] The invention relates to the medical field, in particular to vaccines and vaccine identification, in particular to an immunogenic polysaccharide and its identification method, and an immunogenic polysaccharide vaccine and its identification method. Background technique [0002] The polysaccharide substances present in bacteria play an important role in bacterial recognition, signal transmission, adhesion, infection and defense. By extracting and purifying polysaccharide antigens that cause specific protective effects in bacteria, specific polysaccharide vaccines can be produced. Inoculation of polysaccharide vaccines can prevent infection of various diseases. It is especially important to control the quality of polysaccharide vaccines. Only after the vaccines are identified correctly and the components are correct, it is necessary to carry out analysis work such as inspection and content determination. Especially when there are multiple antigens in the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/095A61K39/102A61K39/02A61K39/085A61K39/00A61K39/09A61K39/106A61K39/08A61P31/04A61P31/10G01N33/557G01N33/558G01N21/82
CPCA61K39/0002A61K39/0266A61K39/0275A61K39/08A61K39/085A61K39/092A61K39/095A61K39/102A61K39/107A61P31/04A61P31/10G01N21/82G01N33/557G01N33/558Y02A50/30
Inventor 王倩罗丽娜苏玉婷钟正丹王超李银波敬小兵刘思利张建军凌燕杨冬妮黄放王岩薛平
Owner 复星安特金(成都)生物制药有限公司
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