Staphylococcal enterotoxin C3 preparation, formulation, dosage and application thereof

Abstract

The invention comprises staphylococcal enterotoxin C3 preparation, formulation, dosage and application thereof, belonging to the field of biological engineering. Staphylococcus aureus is cultivated, separated and purified to prepare the staphylococcal enterotoxin C3 (Staphylococcal Enterotoxin C3, SEC3); SEC3 is prepared into injection and oral formulations, such as oral liquid, capsules, tablets, pellets and the like, or SEC 3 is prepared into fusion protein and then is prepared into injection formulation; the effective dose range of clinic amount of generated formulation performing drug administration through muscle and blood is more than 3ng / day; the effective dose range of clinic amount of generated formulation performing oral administration is more than 800 ng / day. The SEC3 of the invention is suitable for treating diseases of tumor, virus and immunodeficiency.

Description

technical field [0001] The invention belongs to bioengineering, and relates to the preparation method, purification method, preparation, dosage and application of Staphylococcal Enterotoxin C3 (Staphylococcal Enterotoxin C3, SEC3) in the preparation of tumors, viruses and drugs for regulating body immunity. The preparation, dosage and application fields of SEC3 also include the range of SEC3 obtained by other methods not in the present invention. Background technique [0002] Superantigen (SAg) is a new immunological term first introduced by the Swedish scientist White in 1989. It is a protein molecule encoded by bacteria or viruses. It does not require antigen (APC) processing and is directly bound to the APC membrane in the form of a complete protein molecule. The combination of MHC-II molecules outside the antigen-binding groove leads to the activation and proliferation of T cells with specific Vβ fragments. The number of activated T cells is thousands of times or even te...

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Problems solved by technology

[0017] At present, some people have used genetic engineering to prepare Staphylococcus aureus enterotoxin superantigen. For example, Xu Mingkai et al. cloned the SEC2 gene into pET~28a for expression, but the expressed recombinant product had 36 more amino acids than the natural protein, so the antigenic determinant and product activity are more likely to change

[0018] In addition, in the current research on SEC, the main research is SEC1, SEC2, and there is no literature published on SEC3. There is only one CN 1283264C patent, which discloses the invention of SE oral preparations prepared by Staphylococcus aureus, and the preparation of SEC3 is the subject of this patent. A small part, but only defined as isolated from one of the strains of Staphylococcus aureus in CGMCC0341, CGMCC0342, CGMCC0485, CGMCC0165, CGMCC0381, CGMCC0780, CGMCC0662

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