24-valence pneumococcus polysaccharide vaccine and identification method thereof

A technology of pneumococcal polysaccharide and pneumococcus, which is applied in the medical field, can solve the problems of difficult formation of precipitation lines, influence of test results, difficulty in implementation of identification tests, etc., achieve good results, and overcome the effect of poor sensitivity

Inactive Publication Date: 2018-09-18
成都安特金生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The whole process takes about 2 days or even longer, and the antigen and antibody are contacted by free diffusion. 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. The dilution of the free diffusion process will lead to If the concentration is too small, no precipitation line will be produc

Method used

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  • 24-valence pneumococcus polysaccharide vaccine and identification method thereof
  • 24-valence pneumococcus polysaccharide vaccine and identification method thereof
  • 24-valence pneumococcus polysaccharide vaccine and identification method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0071] The invention provides a pneumococcal polysaccharide, the polysaccharide is identified by immune rate turbidimetry, and the immune rate turbidimetry at least includes contacting the polysaccharide solution with the corresponding antibody to form an antigen-antibody complex, and then the immune rate scatter Nephelometric determination of the reaction rate value of the antigen-antibody complex. In other words, polysaccharides are identified by the rate unit value measured by the specific combination of antigen and antibody to form an antigen-antibody complex.

[0072] The further optimized technical solution of this embodiment is that the 24-valent pneumococcal polysaccharide includes capsular polysaccharides of any 24 serotypes of pneumococcus.

[0073] The further optimized technical solution of this embodiment is that the capsular polysaccharides of any 24 serotypes of pneumococcus include pneumococcal type 1 capsular polysaccharide, pneumococcal type 2 capsular polysa...

Embodiment 2

[0089] The present invention provides a 24-valent pneumococcal polysaccharide vaccine, the pneumococcal polysaccharide vaccine is identified through the turbidimetry of the immune rate, and the turbidimetry of the immune rate 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.

[0090] The further optimized technical solution of this embodiment is that the polysaccharide in the 24-valent pneumococcal polysaccharide vaccine contains capsular polysaccharides of any 24 serotypes of pneumococcus.

[0091] The further optimized technical solution of this embodiment is that the capsular polysaccharides of any 24 s...

Embodiment 3

[0108] (1) Sample source: pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 9N, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F capsular polysaccharide standard products were purchased from ATCC, pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 9N, 10A, 11A, 12F, 14 , 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F antisera were purchased from the Danish National Serum Institute.

[0109] (2) Prepare the following pneumococcal polysaccharide stock solution and polysaccharide vaccine according to the method published by another invention patent of our company CN201010129404.2: pneumococcal type 1 capsular polysaccharide, pneumococcal type 2 capsular polysaccharide, pneumococcal type 3 capsular polysaccharide, pneumonia Pneumococcus type 4 capsular polysaccharide, pneumococcal type 5 capsular polysaccharide, pneumococcal type 6A capsular polysaccharide, pneumococcal type 6B capsular polysaccharide, pneumococcal type 7F capsular polysaccharide, pneumococca...

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Abstract

The invention relates to a 24-valence pneumococcus polysaccharide vaccine and an identification method, namely an immune rate scatter turbidimetry thereof. The immune rate scatter turbidimetry at least comprises the steps of enabling a polysaccharide antigen to be in contact with corresponding antibodies so as to form an antigen-antibody compound, and measuring the reaction rate value of the antigen-antibody compound by virtue of the immune rate scatter turbidimetry. The rate scatter turbidimetry is a technical measure established based on an immunochemical method, and the intensity change ofscattered light of antigen-antibody compound particles suspended in a small cup can be measured by virtue of the rate scatter turbidimetry, the reaction rate is measured and is in a linear relation with the concentration of an antigen and/or an antibody in a certain range, and the light intensity is changed once the reaction is started, so that a reaction result can be obtained within dozens of seconds. The method is strong in specificity and high in sensitivity, the detection time is saved, and the antigen is in direct contact with the antibody, so that the detection of low-concentration samples is promoted, and the method can be applied to the identification of a stock solution and/or a semi-finished product and/or a finished product in the production process of the vaccine.

Description

technical field [0001] The invention relates to the medical field, in particular to vaccines and vaccine identification, in particular to a 24-valent pneumococcal polysaccharide vaccine and an identification method thereof. Background technique [0002] Streptococcus pneumoniae was first isolated in 1881. It can cause bronchitis, pneumonia, otitis media and other diseases in respiratory tract infections, and more serious diseases such as meningitis and sepsis when invading the blood. It is the first pathogen causing serious diseases such as meningitis, bacteremia and pneumonia in children. Effective and safe vaccination is an effective measure to prevent Streptococcus pneumoniae infection, and the quality control of pneumonia vaccine is particularly important. The identification test is to judge the authenticity of the drug by using the special chemical behavior (such as chemical reaction, determination of the physical and chemical constants of the drug, etc.) or the charac...

Claims

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Application Information

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IPC IPC(8): A61K39/116A61K39/09A61P31/04C08B37/00G01N15/00
CPCA61K39/092A61K2039/70A61P31/04C08B37/00G01N15/00
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 成都安特金生物技术有限公司
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