Active superantigen immune activation compound biological injection preparation S and its preparation method

Abstract

The present invention relates to the field of biopharmaceutical technology, and discloses an active superantigen immune activation compound biological injection preparation S and a preparation method thereof. The active antigen components carefully extracted from lactic acid bacteria or yeast retain the natural immune activation characteristics of microorganisms, and further enhance the immunomodulatory function thereof by matching a variety of amino acids, such as lysine, arginine, glutamine and cysteine. The preparation S can penetrate into the cell level of the body, activate and enhance the activity of TC cells, thereby effectively improving the overall immune function. The preparation S can also accurately repair necrotic, degenerated, atrophic and fibrotic allergic tissue cells, and restore the normal structure and function of tissues by promoting cell regeneration and remodeling. At the same time, the preparation S can also promote the regeneration and repopulation of capillaries, and provide sufficient nutrition and oxygen support for tissue repair. The preparation S can significantly improve skin quality, reduce wrinkles and spots, and make the skin firmer and smoother.

Description

Technical Field

[0001] The present invention relates to the technical field of biopharmaceuticals, and in particular to an active superantigen immune-activating compound biological injection preparation S and a preparation method thereof. Background Art

[0002] In the vast field of immunology and cell biology, exploring new biological agents that can effectively activate the immune system and promote cell repair and regeneration has always been the direction of unremitting efforts of scientific researchers. The in-depth study of this field is not only related to the improvement of human health, but also the innovation and breakthrough of disease treatment methods.

[0003] Traditional biological preparations, such as certain vaccines, immunomodulators and cell growth factors, can improve the body's immune function and cell status to a certain extent, but their effects are often limited and may be accompanied by significant side effects. In addition, the preparation process of these biological preparations is usually complicated and costly, which limits their widespread clinical application. Therefore, the development of a new type of biological preparation that is efficient, safe, easy to prepare and cost-controlled has become an urgent need for current research. For this purpose, an active superantigen immune activation compound biological injection preparation S and a preparation method are proposed. Summary of the invention

[0004] In view of the deficiencies of the prior art, the present invention provides an active superantigen immune-activating compound biological injection preparation S and a preparation method to solve the background technical problems.

[0005] In the first aspect, to achieve the above-mentioned purpose, the present invention provides the following technical scheme: an active superantigen immune activation compound biological injection preparation S, which comprises an active antigen component extracted from a specific microorganism, and a plurality of amino acids matched in a specific ratio, wherein the active antigen component is derived from screened and treated lactic acid bacteria or yeast, and the preparation contains 1 μg to 1g of lysine, 0.1 μg to 500mg of arginine, 5 μg to 200mg of glutamine and 0.5 μg to 100mg of cysteine ​​for every 1 μg of active antigen component.

[0006] Preferably, the active antigen component is extracted from lactic acid bacteria, and each 1 μg of the active antigen component contains 50 μg to 500 mg of lysine, 1 μg to 200 mg of arginine, 10 μg to 100 mg of glutamine and 1 μg to 50 mg of cysteine.

[0007] Preferably, the active antigen component is extracted from yeast, and each 1 μg of the active antigen component contains 1 μg to 100 mg of lysine, 0.1 μg to 100 mg of arginine, 5 μg to 150 mg of glutamine and 0.5 μg to 80 mg of cysteine.

[0008] In the second aspect, a method for preparing an active superantigen immune-activating compound biological injection preparation S, the preparation method prepares the active superantigen immune-activating compound biological injection preparation S described in the first aspect, comprising the following steps:

[0009] Raw material preparation: select lactic acid bacteria or yeast strains with immune activity for fermentation culture; during the fermentation culture process, control the appropriate temperature, humidity, pH value and nutrient ratio to obtain high-quality fermentation products.

[0010] Extraction and purification of active antigen components: The fermented lactic acid bacteria or yeast are crushed to release the active antigen components in the cells; then, the active antigen components are extracted and purified by centrifugation, filtration and chromatography to obtain active antigen components with higher purity;

[0011] Amino acid ratio and mixing: According to the ratio described in the first aspect, lysine, arginine, glutamine and cysteine ​​are put into sterile water and mixed; after the mixing is completed, the active antigen component is connected with the amino acid using biocoupling technology to form preparation S.

[0012] Processing and testing: The prepared preparation S is further processed, including sterilization and filling, to prepare a biological injection preparation that meets the requirements.

[0013] Preferably, during the fermentation culture process, one or more growth factors that promote the growth of lactic acid bacteria or yeast and the production of active antigen components are added to the culture medium. These growth factors include but are not limited to vitamins, minerals and nucleotides to further improve the quality of the fermentation product and the yield of active antigen components.

[0014] Preferably, in the extraction and purification steps of the active antigen components, ultrafiltration, nanofiltration or reverse osmosis membrane separation technology is used to more effectively remove impurities and improve the purity of the active antigen components.

[0015] Preferably, during the amino acid proportioning and mixing step, one or more stabilizers are added to the amino acid solution. These stabilizers include but are not limited to sugars, polyols, and amino acid analogs to improve the stability of the preparation and extend its shelf life.

[0016] Preferably, in the amino acid matching and mixing step, after the active antigen component is fully connected with the amino acid, at least one filtration purification is performed.

[0017] Preferably, in the processing and testing step, high temperature steam sterilization or ethylene oxide sterilization is used to sterilize the preparation to ensure its sterility.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] The present invention retains the natural immune activation characteristics of microorganisms by carefully extracting active antigen components from lactic acid bacteria or yeast, and further enhances its immunoregulatory function by matching a variety of amino acids, such as lysine, arginine, glutamine and cysteine; this preparation S can penetrate into the body's cellular level, activate and enhance the activity of TC cells, thereby effectively improving the overall immune function; preparation S can also accurately repair necrotic, degenerated, atrophic and fibrotic allergic tissue cells, and restore the normal structure and function of tissues by promoting cell regeneration and remodeling; at the same time, the preparation S can also promote the regeneration and repopulation of capillaries, providing sufficient nutrition and oxygen support for tissue repair; the preparation S can significantly improve skin quality, reduce wrinkles and spots, and make the skin firmer and smoother.

[0020] In summary, this preparation not only has significant immune activation and cell repair functions, but also has excellent skin beauty effects.

[0021] Other features and advantages of the present invention will be described in the following description, and partly become apparent from the description, or understood by practicing the present invention. The purpose and other advantages of the present invention can be realized and obtained by the structures pointed out in the description, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 The present invention is a flow chart of the preparation method of the active superantigen immune activation compound biological injection preparation S.

[0023] Figure 2 This is a diagram showing the composition of the active superantigen immune-activating compound biological injection preparation S of the present invention. DETAILED DESCRIPTION

[0024] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this technical field without creative work are within the scope of protection of the present invention.

[0025] See also Figure 1 and Figure 2The present invention provides an active superantigen immune activation compound biological injection preparation S, which comprises an active antigen component extracted from a specific microorganism and a plurality of amino acids in a specific ratio, wherein the active antigen component is derived from screened and treated lactic acid bacteria or yeast, and the preparation contains 1 μg to 1g of lysine, 0.1 μg to 500mg of arginine, 5 μg to 200mg of glutamine and 0.5 μg to 100mg of cysteine ​​per 1 μg of active antigen component.

[0026] Embodiment 1:

[0027] The active antigen component is extracted from lactic acid bacteria, and each 1 μg of the active antigen component contains 50 μg to 500 mg of lysine, 1 μg to 200 mg of arginine, 10 μg to 100 mg of glutamine and 1 μg to 50 mg of cysteine.

[0028] Embodiment 2:

[0029] The active antigen component is extracted from yeast, and each 1 μg of the active antigen component contains 1 μg to 100 mg of lysine, 0.1 μg to 100 mg of arginine, 5 μg to 150 mg of glutamine and 0.5 μg to 80 mg of cysteine.

[0030] Embodiment three:

[0031] This embodiment provides a method for preparing an active superantigen immune-activating compound biological injection preparation S. The preparation method prepares the active superantigen immune-activating compound biological injection preparation S of Example 2, comprising the following steps:

[0032] Raw material preparation: select lactic acid bacteria or yeast strains with immune activity for fermentation culture; during the fermentation culture process, control the appropriate temperature, humidity, pH value and nutrient ratio to obtain high-quality fermentation products, and add one or more growth factors that promote the growth of lactic acid bacteria or yeast and the production of active antigen components, such as vitamins, minerals and nucleotides, to the culture medium.

[0033] Extraction and purification of active antigen components: The fermented lactic acid bacteria or yeast are crushed to release the active antigen components in the cells; then, the active antigen components are extracted and purified by centrifugation, filtration (such as ultrafiltration, nanofiltration or reverse osmosis membrane separation technology) and chromatography steps to obtain active antigen components with higher purity;

[0034] Amino acid ratio and mixing: According to the ratio of Example 2, lysine, arginine, glutamine and cysteine ​​are mixed in sterile water, and one or more stabilizers, such as sugars, polyols, amino acid analogs, etc., are added to the amino acid solution; after mixing, the active antigen component is connected to the amino acid using biocoupling technology, and then filtered and purified at least once to form Preparation S.

[0035] Processing test: The prepared preparation S is further processed, including sterilization (such as high-temperature steam sterilization or ethylene oxide sterilization) and filling, to prepare a biological injection preparation that meets the requirements.

[0036] In this ratio, the active antigen components extracted from lactic acid bacteria are combined with higher concentrations of lysine, arginine, glutamine and cysteine; high concentrations of lysine help to enhance the body's immune response because it plays an important role in the proliferation and differentiation of immune cells. At the same time, arginine and glutamine, as important energy sources and signaling molecules, can support the activity and function of immune cells. In addition, an appropriate amount of cysteine ​​helps maintain the redox balance in cells and protects cells from oxidative stress damage; this ratio focuses more on enhancing the body's overall immune function, promoting the activation and proliferation of immune cells, and thus more effectively fighting pathogens and abnormal cells.

[0037] Embodiment 4:

[0038] This embodiment provides a method for preparing an active superantigen immune-activating compound biological injection preparation S. The preparation method prepares the active superantigen immune-activating compound biological injection preparation S of embodiment 3, comprising the following steps:

[0039] Raw material preparation: select lactic acid bacteria or yeast strains with immune activity for fermentation culture; during the fermentation culture process, control the appropriate temperature, humidity, pH value and nutrient ratio to obtain high-quality fermentation products, and add one or more growth factors that promote the growth of lactic acid bacteria or yeast and the production of active antigen components, such as vitamins, minerals and nucleotides, to the culture medium.

[0040] Extraction and purification of active antigen components: The fermented lactic acid bacteria or yeast are crushed to release the active antigen components in the cells; then, the active antigen components are extracted and purified by centrifugation, filtration (such as ultrafiltration, nanofiltration or reverse osmosis membrane separation technology) and chromatography steps to obtain active antigen components with higher purity;

[0041] Amino acid ratio and mixing: According to the ratio of Example 3, lysine, arginine, glutamine and cysteine ​​are mixed in sterile water, and one or more stabilizers, such as sugars, polyols, amino acid analogs, etc., are added to the amino acid solution; after mixing, the active antigen component is connected to the amino acid using biocoupling technology, and then filtered and purified at least once to form Preparation S.

[0042] Processing test: The prepared preparation S is further processed, including sterilization (such as high-temperature steam sterilization or ethylene oxide sterilization) and filling, to prepare a biological injection preparation that meets the requirements.

[0043] In this combination, the active antigen components extracted from yeast are combined with lower concentrations of amino acids; this combination may be milder and suitable for situations requiring mild immune regulation and cell repair; low concentrations of amino acids may help reduce potential immune overreactions while still supporting the normal functioning of the immune system; in addition, the active antigen components extracted from yeast have specific immunoregulatory properties and can fine-tune specific immune cells or signaling pathways; this combination is more suitable for adjuvant treatment of autoimmune diseases, allergic reactions or chronic diseases that require the promotion of tissue repair and regeneration.

[0044] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. Active superantigen immune activation compound biological injection preparation S, characterized in that: The preparation contains active antigen components extracted from specific microorganisms and multiple amino acids in specific proportions, wherein the active antigen components are derived from screened and processed lactic acid bacteria or yeasts, and every 1 μg of the active antigen components in the preparation contains 1 μg to 1g of lysine, 0.1 μg to 500mg of arginine, 5 μg to 200mg of glutamine and 0.5 μg to 100mg of cysteine.

2. The active superantigen immune-activating compound biological injection preparation S according to claim 1, characterized in that: The active antigen component is extracted from lactic acid bacteria, and each 1 μg of the active antigen component contains 50 μg to 500 mg of lysine, 1 μg to 200 mg of arginine, 10 μg to 100 mg of glutamine and 1 μg to 50 mg of cysteine.

3. The active superantigen immune-activating compound biological injection preparation S according to claim 2, characterized in that: The active antigen component is extracted from yeast, and each 1 μg of the active antigen component contains 1 μg to 100 mg of lysine, 0.1 μg to 100 mg of arginine, 5 μg to 150 mg of glutamine and 0.5 μg to 80 mg of cysteine.

4. A method for preparing an active superantigen immune-activating compound biological injection preparation S, characterized in that: The preparation method prepares the active superantigen immune activation compound biological injection preparation S according to any one of claims 1 to 3, comprising the following steps: Raw material preparation: select lactic acid bacteria or yeast strains with immune activity for fermentation culture; during the fermentation culture process, control the appropriate temperature, humidity, pH value and nutrient ratio to obtain high-quality fermentation products. Extraction and purification of active antigen components: The fermented lactic acid bacteria or yeast are crushed to release the active antigen components in the cells; then, the active antigen components are extracted and purified by centrifugation, filtration and chromatography to obtain active antigen components with higher purity; Amino acid ratio and mixing: according to the ratio according to any one of claims 1 to 3, lysine, arginine, glutamine and cysteine ​​are put into sterile water and mixed; after the mixing is completed, the active antigen component is connected with the amino acid by using biocoupling technology to form preparation S. Processing and testing: The prepared preparation S is further processed, including sterilization and filling, to prepare a biological injection preparation that meets the requirements.

5. The method for preparing the active superantigen immune-activating compound biological injection preparation S according to claim 4, characterized in that: During the fermentation process, one or more growth factors that promote the growth of lactic acid bacteria or yeast and the production of active antigen components are added to the culture medium. These growth factors include but are not limited to vitamins, minerals and nucleotides to further improve the quality of the fermentation product and the yield of active antigen components.

6. The method for preparing the active superantigen immune-activating compound biological injection preparation S according to claim 4, characterized in that: In the extraction and purification steps of active antigen components, ultrafiltration, nanofiltration or reverse osmosis membrane separation technology is used to more effectively remove impurities and improve the purity of active antigen components.

7. The method for preparing the active superantigen immune-activating compound biological injection preparation S according to claim 4, characterized in that: During the amino acid proportioning and mixing step, one or more stabilizers are added to the amino acid solution. These stabilizers include but are not limited to sugars, polyols, and amino acid analogs to improve the stability of the preparation and extend its shelf life.

8. The method for preparing the active superantigen immune-activating compound biological injection preparation S according to claim 4, characterized in that: In the amino acid matching and mixing step, after the active antigen component is fully connected with the amino acid, it is filtered and purified at least once.

9. The method for preparing the active superantigen immune-activating compound biological injection preparation S according to claim 4, characterized in that: During the processing and testing step, the preparation is sterilized by high temperature steam sterilization or ethylene oxide sterilization to ensure its sterility.

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