Cortex albiziae saponin adjuvant and preparation method thereof, as well as vaccine preparation containing adjuvant and application thereof

Abstract

The invention relates to a cortex albiziae saponin adjuvant with the effect of an immunologic adjuvant and a preparation method thereof, as well as a vaccine preparation containing the saponin adjuvant, and the application of the adjuvant and the vaccine preparation in preparing vaccine preparations. The saponin comprises cortex albiziae total saponins extracted and separated from the traditional Chinese medicine cortex albiziae, a cortex albiziae saponin adjuvant active effective part A and a cortex albiziae saponin adjuvant active effective part B, can induce local tissues to generate cytokine and chemokine, can recruit immune cells to an injection part, can induce a body to simultaneously generate Th1 and Th2 type immune responses, is capable of inducing a body to generate stronger cell immune and body fluid immune responses on the vaccine than an existing alumina gel in the prior art, can be used as an immune adjuvant of a plurality of vaccines to play a perfect immune effect. The vaccine by using the saponin as an adjuvant is simple in preparation process and method, easy in quality control and convenient to use, can be can be frozen for storage.

Description

technical field [0001] The present invention relates to the total saponins of Albizia Julibrissin with the function of immune adjuvant extracted and separated from the traditional Chinese medicine Albizia Julibrissin, the active effective part A of the adjuvant of Albizia Julibis saponin and the active effective part B of the adjuvant of Albizia Julibis saponin, and its preparation method and containing the saponin Adjuvanted vaccine formulations, and their use in the preparation of vaccine formulations. Background technique [0002] Vaccination is the most economical and effective means to prevent and control infectious diseases. New vaccines such as DNA vaccines, recombinant vaccines, and synthetic peptide vaccines are a type of biological preparations that have developed rapidly in recent years. Compared with conventional vaccines, they have the advantages of high antigen purity, strong specificity, and good safety. However, these novel vaccines have weak immunogenicity ...

AI Technical Summary

Problems solved by technology

However, there are some problems with aluminum colloid adjuvant: ① It mainly plays a protective role by inducing Th2 type immune response to produce antibodies, and cannot induce Th1 type immune response and cell-mediated immune response, so it is only suitable for those whose main protective immunity is antibody. Vaccines (Exley C, Siesjo P, Eriksson H. The immunobiology of aluminum adjuvants: how do they really work? Trends Immunol 2010; 31: 103-109); ② against human immunodeficiency virus, hepatitis C virus, herpes simplex virus, Influenza virus and various antigens such as schistosomiasis, pertussis and typhoid have no adjuvant effect[O'Hagan DT, De Gregorio E. The path to a successful vaccine adjuvant - 'the long and winding road' . Drug Discov Today 2009; 14: 541–551]; ③ can promote the production of IgE antibodies, and can easily induce allergic reactions in the body; ④ local reactions can form granulomas, and very few local aseptic abscesses can occur; Afraid of freezing, aluminum glue is easy to denature after freezing; ⑥ It may affect the nervous system of humans and animals

However, Quil A has serious defects: ① strong hemolysis, severe side effects, can cause local tissue necrosis, and even systemic adverse reactions and poisoning [Waite DC, Jacobson EW, Ennis FA, Edelman R, White B, Kammer R, et al . Three double-blind, randomized trials evaluating the safety and tolerance of different formulations of the saponin adjuvant QS-21. Vaccine 2001; 19: 3957-7.]

② Its main active ingredients such as QS-21, QS-17, QS-18 and QS-7 have acyl groups in their molecular structures, which are easy to hydrolyze, and their deacylated hydrolyzate loses the ability to induce Th1 type immune response and produce specific CTL Ability, can only trigger Th2 type immune response [Kensil CR. Immunomodulatory adjuvants from Quillaja saponaria . Immunopotentiators in Modern Vaccines 2007; 109-22.]; ③ South American soap tree resources are scarce, and the total saponin content is low. At the same time, the molecular weight of the monomer compound in Quil A is large, the chemical structure is very complex, and it is difficult to separate and prepare

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