24-valence pneumococcus polysaccharide vaccine and identification method thereof

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...

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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 produced, and if the molecular weight of the sample is too large, it will not be conducive to diffusion and affect the test effect. Especially for samples whose antigenicity is reduced due to a series of reactions during the preparation process, it is even more difficult to meet the requirements of the immunological double diffusion method. Antigen concentration, which makes it difficult to perform differential tests

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