Immune combined preparation and preparation method and application thereof

Abstract

The invention discloses an immune combined preparation and a preparation method and an application thereof, wherein the immune combined preparation comprises a streptococcus pneumoniae capsular polysaccharide-CRM197 protein conjugate and a haemophilus influenzae B capsular polysaccharide-CRM197 protein conjugate, wherein the mass ratio of a haemophilus influenzae B capsular polysaccharide to a CRM1197 protein is (0.3-1):1. The mass content of the haemophilus influenzae type B capsular polysaccharide is 10-15 [mu]g/dose. The combined vaccine can effectively induce a body to produce high-titer and specific antibodies against the selected serotype streptococcus pneumoniae polysaccharide and haemophilus influenzae type B capsular polysaccharide; and no interference exists between antigen components, and higher immune effect is achieved by screening the combination way; after the vaccine is prepared, the number of vaccinations can be reduced, the immune procedure is simplified, and human and animal diseases caused by the bacteria are effectively prevented.

Description

technical field [0001] The invention relates to an immune combination preparation and its preparation method and application, belonging to the field of biomedicine. Background technique [0002] 1. Streptococcus pneumoniae and its epidemiology [0003] Streptococcus pneumoniae (Streptococcus pneumoniae) is one of the main pathogens causing bacterial infectious diseases, which can cause pneumonia, meningitis, sepsis, otitis media and other diseases, 5% to 10% of healthy adults and 20% to 40% of children in the nasopharynx Such bacteria are carried in the respiratory tract. The bacterium is a Gram-positive diplococcus arranged in pairs or in short chains. The virulent strain forms capsular polysaccharide outside the bacterium, and the virulent strain is an important pathogenic bacterium that causes human diseases. Pneumococcus lives in the nasopharyngeal cavity of normal people and can cause bacterial lobar pneumonia, pneumonia, bronchitis, meningitis, sepsis, otitis media a...

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Problems solved by technology

There are no relevant products on the market at present, but there are some literature reports, such as CN103623401A discloses a polyvalent pneumococcal capsular polysaccharide-protein conjugate composition and its preparation method, and discloses an immune composition containing pneumococcal polysaccharide, but It is limited to the combination of pneumococcal vaccine and protein, and does not give specific examples of combined vaccines; as CN101112619A discloses a vaccine composition, which discloses comprising pneumococcal polysaccharide and HIB polysaccharide in the vaccine composition, and embodiment 4 discloses The preparation method of Hib-11 valent pneumococcal conjugated (Hib / Strep11V) vaccine, but the method that it adopts is conventional method, does not limit the composition ratio and process method of each vaccine, as reported in CN106109486A 13 valent multi pneumococcal polysaccharide conjugate vaccine and HIB conjugate vaccine, the combination vaccine reported in the patent is the clinical mixture of single vaccines, but the applicant found that when implementing the disclosed content, the patent provides The technical scheme has the following problems: one, the proportioning range is too large, and the immune effect of the single vaccine is poor when the extreme value is taken, and it is easy to cause adverse reactions; For membrane saccharide antigens, through the continuous advancement of the applicant’s research, we found that the degree of polymerization of capsular saccharides has a certain impact on the immune effect, and the correlation between the two can be determined. better immunity

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