Polysaccharide protein conjugate vaccine and identification method thereof

Abstract

The invention relates to a polysaccharide protein conjugate and an identification method thereof, in particular to a polysaccharide protein conjugate vaccine made from the polysaccharide protein conjugate, and an identification method thereof. A rate scattering turbidimetry is a technical means established based on an immunochemical method, and can measure scattered-light intensity changes causedby antigen-antibody complex aggregate particles suspended in a small cup, and a reaction rate value is acquired within tens seconds; complex aggregate particles are formed through the antigen-antibodyreaction, and have different rates according to different concentrations of antigens and / or antibodies. The identification method has strong specificity and sensitivity, and the detection time is shortened; the antigens directly contact with the antibodies, and accordingly, low-concentration sample detection is benefited; the identification method can be applied to identification of stock solutions and / or semi-finished products and / or finished products in the process of vaccine production.

Description

Technical field [0001] The present invention relates to the medical field, in particular to the identification of vaccines and vaccines, in particular to an immunogenic polysaccharide protein conjugate and its identification method and a polysaccharide protein conjugate vaccine and its identification method. Specifically, it relates to a polysaccharide protein binding vaccine and its identification method. Background technique [0002] Vaccination is an effective measure to prevent infection, and vaccine quality control is particularly important. The identification test uses the special chemical behavior (such as chemical reaction, determination of the physical and chemical constants of the drug, etc.) or the characteristics of spectrum, chromatography, biology and other characteristics of the molecular structure of the drug to judge the authenticity of the drug. The identification of drugs is the first task in drug quality inspection. Only after the drug has been identified co...

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.

In addition, 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, especially for the preparation process. For samples whose antigenicity is reduced due to a series of reactions, it is more difficult to achieve the appropriate antigen concentration required in the immunodiffusion method, which makes it difficult to implement the identification test

Images