Active superantigen immune reconstitution compound biological injection preparation A and its preparation method

Abstract

The present invention relates to the field of biopharmaceutical technology, and discloses an active superantigen immune reconstruction compound biological injection preparation A and a preparation method. The present invention adopts a variety of superantigens with immunomodulatory activity. These superantigens have high immunostimulatory activity, can fully and deeply activate the body's immune system, and significantly improve the effect of immunomodulation; at the same time, a variety of amino acid mixtures in specific proportions are added to the preparation, and these amino acids play an important role in immunomodulation, can synergistically enhance the function of the immune system, and also provide the energy and signal molecules required by immune cells, further improving the comprehensiveness and depth of immunomodulation; the active superantigen is connected to the amino acid mixture by chemical bonding technology, and the bioactive peptide is connected to the superantigen-amino acid complex, which not only ensures the stability and bioavailability of each component in the preparation, but also improves the overall stability and safety of the preparation.

Description

Technical Field

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

[0002] In the field of biomedicine, the functional recovery and regulation of the immune system has always been a hot topic of research; with the continuous development of biotechnology, people have gradually realized the important role of active antigen components in immune reconstruction and regulation. These active antigen components are usually derived from natural microorganisms or their genetically engineered variants. They can activate the body's immune system, promote the proliferation and differentiation of immune cells, and thus enhance the body's overall immune function.

[0003] However, although existing immunomodulators, such as immunosuppressants and immunoenhancers, can regulate the body's immune function to a certain extent, their effects are often limited and there are significant individual differences; some patients may not respond well to these drugs, and may even experience serious side effects, such as increased risk of infection and liver damage. In addition, the mechanism of action of existing immunomodulators is relatively single, and they can often only regulate a certain link of the immune system, making it difficult to comprehensively and deeply improve the body's immune status. For this reason, an active superantigen immune reconstruction compound biological injection preparation A 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 reconstitution compound biological injection preparation A 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 solution: Active superantigen immune reconstruction compound biological injection preparation A, the preparation comprises the following components and their ratio parameters:

[0006] A variety of active superantigens with immunomodulatory properties, accounting for 10%-40% of the total preparation weight;

[0007] A mixture of multiple amino acids in specific proportions, including lysine, arginine, glutamine, cysteine ​​and aspartic acid, wherein the proportions of each amino acid in the mixture are 15%-25% of lysine, 10%-20% of arginine, 20%-30% of glutamine, 5%-15% of cysteine, and 5%-15% of aspartic acid, and the amino acid mixture accounts for 30%-60% of the total preparation weight;

[0008] One or more bioactive peptides, accounting for 10%-30% of the total preparation mass.

[0009] Preferably, the active superantigen is derived from natural microorganisms or genetically engineered microorganisms and has a high immunostimulatory activity.

[0010] Preferably, the bioactive peptide is obtained by hydrolysis of natural protein or synthesized by genetic engineering method and has specific biological activity.

[0011] Preferably, the specific functional groups of the active superantigen are connected to the corresponding functional groups in the amino acid mixture through amide bonds or ester bonds to form a stable superantigen-amino acid complex;

[0012] The bioactive peptide is connected to the remaining functional groups in the superantigen-amino acid complex through its terminal functional groups or through other connection technologies to ensure the stability and bioavailability of the bioactive peptide in the preparation.

[0013] In the second aspect, a method for preparing an active superantigen immune reconstitution compound biological injection preparation A, the preparation method prepares the active superantigen immune reconstitution compound biological injection preparation A described in the second aspect, comprising the following preparation steps:

[0014] Superantigens with immunomodulatory activity are screened from natural microorganisms or genetically engineered microorganisms, and high-purity and high-activity superantigens are obtained through fermentation, extraction and purification steps.

[0015] According to the amino acid ratio described in claim 1, the amino acid raw materials of lysine, arginine, glutamine, cysteine ​​and aspartic acid are weighed and prepared into a uniform amino acid mixture through the steps of dissolving, mixing and adjusting the pH value.

[0016] Bioactive peptides are obtained from natural proteins by enzymatic or acid-base hydrolysis, or by genetic engineering to synthesize peptide compounds with specific biological activity.

[0017] The extracted and purified superantigen is chemically bonded to the prepared amino acid mixture to form a stable superantigen-amino acid complex.

[0018] The bioactive peptide is connected to the superantigen-amino acid complex to form the final active superantigen immune reconstitution compound biological injection preparation A.

[0019] The prepared preparation A is sterilized and then subjected to quality testing, including purity, activity, sterility testing, and stability testing indicators. If it meets the standards, it is packaged and put into storage.

[0020] Preferably, the active superantigen is screened out by high-throughput screening or genetic engineering technology.

[0021] Preferably, in the fermentation step, an optimized fermentation medium is used, which contains a carbon source, a nitrogen source, an inorganic salt and a growth factor that are beneficial to the production and accumulation of superantigens, so as to further improve the yield and purity of superantigens.

[0022] Preferably, in the sterilization step, a mild sterilization method of low-temperature, long-term sterilization or irradiation sterilization is adopted to ensure the sterility of the preparation while retaining the biologically active ingredients and stability in the preparation to the greatest extent.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] The present invention adopts a variety of superantigens with immunomodulatory activity. These superantigens have high immunostimulatory activity, can fully and deeply activate the body's immune system, and significantly improve the effect of immunomodulation. At the same time, a variety of amino acid mixtures in specific proportions are added to the preparation. These amino acids play an important role in immunomodulation, can synergistically enhance the function of the immune system, and also provide the energy and signal molecules required by immune cells, further improving the comprehensiveness and depth of immunomodulation. Active superantigens are connected to the amino acid mixture, and bioactive peptides are connected to the superantigen-amino acid complex through chemical bonding technology, which not only ensures the stability and bioavailability of each component in the preparation, but also improves the overall stability and safety of the preparation.

[0025] 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

[0026] Figure 1 This is a flowchart of the preparation method of the active superantigen immune reconstitution compound biological injection preparation A of the present invention;

[0027] Figure 2 This is a diagram showing the composition of the active superantigen immune reconstitution compound biological injection preparation A of the present invention. DETAILED DESCRIPTION

[0028] 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.

[0029] See also Figure 1 ,2 The present invention provides an active superantigen immune reconstruction compound biological injection preparation A, which comprises the following components and their ratio parameters:

[0030] Active superantigens derived from natural microorganisms or genetically engineered microorganisms have high immunostimulatory activity and account for 10%-40% of the total preparation weight;

[0031] A mixture of multiple amino acids accounting for 30%-60% of the total preparation weight, wherein the proportions of the amino acids in the mixture are 15%-25% lysine, 10%-20% arginine, 20%-30% glutamine, 5%-15% cysteine, and 5%-15% aspartic acid;

[0032] One or more bioactive peptides account for 10%-30% of the total preparation mass. The bioactive peptides are obtained by hydrolysis of natural proteins or synthesized by genetic engineering methods. They have specific biological activities, such as promoting cell proliferation and inhibiting inflammatory responses.

[0033] Embodiment 1:

[0034] This example provides an active superantigen immune reconstitution compound biological injection preparation A, which comprises the following components and their ratio parameters:

[0035] Active superantigens derived from natural microorganisms or genetically engineered microorganisms, accounting for 10% of the total preparation weight;

[0036] A mixture of various amino acids accounting for 60% of the total preparation weight, wherein the proportions of the various amino acids in the mixture are 15%-25% lysine, 10%-20% arginine, 20%-30% glutamine, 5%-15% cysteine, and 5%-15% aspartic acid;

[0037] One or more biologically active peptides accounting for 30% of the total formulation mass.

[0038] Embodiment 2:

[0039] This example provides an active superantigen immune reconstitution compound biological injection preparation A, which comprises the following components and their ratio parameters:

[0040] Active superantigens derived from natural microorganisms or genetically engineered microorganisms, accounting for 40% of the total preparation weight;

[0041] A mixture of various amino acids accounting for 40% of the total preparation weight, wherein the proportions of the various amino acids in the mixture are 15%-25% lysine, 10%-20% arginine, 20%-30% glutamine, 5%-15% cysteine, and 5%-15% aspartic acid;

[0042] One or more biologically active peptides accounting for 20% of the total formulation mass.

[0043] Embodiment three:

[0044] This example provides an active superantigen immune reconstitution compound biological injection preparation A, which comprises the following components and their ratio parameters:

[0045] Active superantigens derived from natural microorganisms or genetically engineered microorganisms, accounting for 20% of the total preparation weight;

[0046] A mixture of various amino acids accounting for 60% of the total preparation weight, wherein the proportions of the various amino acids in the mixture are 15%-25% lysine, 10%-20% arginine, 20%-30% glutamine, 5%-15% cysteine, and 5%-15% aspartic acid;

[0047] One or more biologically active peptides accounting for 20% of the total formulation mass.

[0048] Embodiment 4:

[0049] This embodiment provides a method for preparing an active superantigen immune reconstitution compound biological injection preparation A. The preparation method prepares the active superantigen immune reconstitution compound biological injection preparation A of Example 1, comprising the following preparation steps:

[0050] Superantigens with immunomodulatory activity are screened out from natural microorganisms or genetically engineered microorganisms using high-throughput screening or genetic engineering technology, and high-purity and high-activity superantigens are obtained through fermentation (using an optimized fermentation medium, which contains a carbon source, nitrogen source, inorganic salts and growth factors that are conducive to the production and accumulation of superantigens to further improve the yield and purity of superantigens), extraction and purification steps.

[0051] According to the amino acid ratio of Example 1, the amino acid raw materials of lysine, arginine, glutamine, cysteine ​​and aspartic acid were weighed, and a uniform amino acid mixture was prepared through the steps of dissolving, mixing and adjusting the pH value.

[0052] Bioactive peptides are obtained from natural proteins by enzymatic or acid-base hydrolysis, or by genetic engineering to synthesize peptide compounds with specific biological activity.

[0053] The extracted and purified superantigen is chemically bonded to the prepared amino acid mixture to form a stable superantigen-amino acid complex.

[0054] The bioactive peptide is connected to the superantigen-amino acid complex to form the final active superantigen immune reconstitution compound biological injection preparation A.

[0055] The prepared preparation A is sterilized by a mild sterilization method such as low-temperature long-term sterilization or irradiation sterilization, and then subjected to quality testing, including purity, activity, sterility testing, and stability testing indicators. If it meets the standards, it will be packaged and put into storage.

[0056] Specifically, the proportion of the first embodiment has the following effects:

[0057] Low concentration of active superantigen: 10% of the total preparation mass. This concentration is suitable for patients who need mild immune stimulation or in the early stages of immune reconstruction to avoid discomfort or side effects that may be caused by excessive immune response.

[0058] High-Proportion Amino Acid Blend: 60% of the total formulation weight provides a rich source of amino acids to help support normal cell function and repair, especially important for those who have experienced immune damage or require nutritional support.

[0059] Moderate proportion of bioactive peptides: accounting for 30% of the total preparation weight. Bioactive peptides play an important role in regulating immune responses and promoting cell growth and differentiation. This ratio helps maintain a balanced immune environment.

[0060] Embodiment five:

[0061] This embodiment provides a method for preparing an active superantigen immune reconstitution compound biological injection preparation A. The preparation method prepares the active superantigen immune reconstitution compound biological injection preparation A of Example 2, comprising the following preparation steps:

[0062] Superantigens with immunomodulatory activity are screened out from natural microorganisms or genetically engineered microorganisms using high-throughput screening or genetic engineering technology, and high-purity and high-activity superantigens are obtained through fermentation (using an optimized fermentation medium, which contains a carbon source, nitrogen source, inorganic salts and growth factors that are conducive to the production and accumulation of superantigens to further improve the yield and purity of superantigens), extraction and purification steps.

[0063] According to the amino acid ratio of Example 2, the amino acid raw materials of lysine, arginine, glutamine, cysteine ​​and aspartic acid were weighed, and a uniform amino acid mixture was prepared through the steps of dissolving, mixing and adjusting the pH value.

[0064] Bioactive peptides are obtained from natural proteins by enzymatic or acid-base hydrolysis, or by genetic engineering to synthesize peptide compounds with specific biological activity.

[0065] The extracted and purified superantigen is chemically bonded to the prepared amino acid mixture to form a stable superantigen-amino acid complex.

[0066] The bioactive peptide is connected to the superantigen-amino acid complex to form the final active superantigen immune reconstitution compound biological injection preparation A.

[0067] The prepared preparation A is sterilized by a mild sterilization method such as low-temperature long-term sterilization or irradiation sterilization, and then subjected to quality testing, including purity, activity, sterility testing, and stability testing indicators. If it meets the standards, it will be packaged and put into storage.

[0068] Specifically, the proportion of the second embodiment has the following effects:

[0069] Higher concentration of active superantigen: 40% of the total preparation mass. This concentration is suitable for patients who need strong immune stimulation or in the later stages of immune reconstitution to accelerate the recovery of immune function.

[0070] Balanced ratio of amino acids and bioactive peptides: The amino acid mixture and bioactive peptides account for 40% and 20% of the total preparation weight respectively. This ratio helps to provide adequate nutritional support while maintaining a certain immune regulatory ability.

[0071] Synergistic Effect: Due to the increased proportion of active superantigens, it produces a stronger synergistic effect with the amino acid mixture and bioactive peptides, thereby promoting immune reconstitution more effectively.

[0072] Embodiment six:

[0073] This embodiment provides a method for preparing an active superantigen immune reconstitution compound biological injection preparation A. The preparation method prepares the active superantigen immune reconstitution compound biological injection preparation A of Example 3, comprising the following preparation steps:

[0074] Superantigens with immunomodulatory activity are screened out from natural microorganisms or genetically engineered microorganisms using high-throughput screening or genetic engineering technology, and high-purity and high-activity superantigens are obtained through fermentation (using an optimized fermentation medium, which contains a carbon source, nitrogen source, inorganic salts and growth factors that are conducive to the production and accumulation of superantigens to further improve the yield and purity of superantigens), extraction and purification steps.

[0075] According to the amino acid ratio of Example 3, the amino acid raw materials of lysine, arginine, glutamine, cysteine ​​and aspartic acid were weighed, and a uniform amino acid mixture was prepared through the steps of dissolving, mixing and adjusting the pH value.

[0076] Bioactive peptides are obtained from natural proteins by enzymatic or acid-base hydrolysis, or by genetic engineering to synthesize peptide compounds with specific biological activity.

[0077] The extracted and purified superantigen is chemically bonded to the prepared amino acid mixture to form a stable superantigen-amino acid complex.

[0078] The bioactive peptide is connected to the superantigen-amino acid complex to form the final active superantigen immune reconstitution compound biological injection preparation A.

[0079] The prepared preparation A is sterilized by a mild sterilization method such as low-temperature long-term sterilization or irradiation sterilization, and then subjected to quality testing, including purity, activity, sterility testing, and stability testing indicators. If it meets the standards, it will be packaged and put into storage.

[0080] Specifically, the proportion of the third embodiment has the following effects:

[0081] Moderate proportion of active superantigens: 20% of the total preparation mass. This concentration is neither too mild nor too strong, and is suitable for most patients who need immune reconstruction.

[0082] High-ratio amino acid mixture: same as in Example 1, accounting for 60% of the total preparation mass, providing a sufficient source of amino acids, which helps to support the normal function and repair of cells.

[0083] Lower bioactive peptide ratio: 20% of the total preparation mass, although lower than that of Example 1 and Example 2, but still sufficient to maintain a certain immunomodulatory ability. This ratio is suitable for patients who are sensitive to bioactive peptides or need to reduce their dosage.

[0084] 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 reconstruction compound biological injection preparation A, characterized in that: The preparation contains the following components and their proportion parameters: A variety of active superantigens with immunomodulatory properties, accounting for 10%-40% of the total preparation weight; A mixture of multiple amino acids in specific proportions, including lysine, arginine, glutamine, cysteine ​​and aspartic acid, wherein the proportions of each amino acid in the mixture are 15%-25% of lysine, 10%-20% of arginine, 20%-30% of glutamine, 5%-15% of cysteine, and 5%-15% of aspartic acid, and the amino acid mixture accounts for 30%-60% of the total preparation weight; One or more bioactive peptides, accounting for 10%-30% of the total preparation mass.

2. The active superantigen immune reconstitution compound biological injection preparation A according to claim 1, characterized in that: The active superantigen is derived from natural microorganisms or genetically engineered microorganisms and has a high immunostimulatory activity.

3. The active superantigen immune reconstitution compound biological injection preparation A according to claim 1, characterized in that: The bioactive peptide is obtained by hydrolyzing natural protein or synthesized by genetic engineering method and has specific biological activity.

4. The active superantigen immune reconstitution compound biological injection preparation A according to claim 1, characterized in that: The specific functional groups of the active superantigen are connected to the corresponding functional groups in the amino acid mixture through amide bonds or ester bonds to form a stable superantigen-amino acid complex; The bioactive peptide is connected to the remaining functional groups in the superantigen-amino acid complex through its terminal functional groups or through other connection technologies to ensure the stability and bioavailability of the bioactive peptide in the preparation.

5. A method for preparing active superantigen immune reconstruction compound biological injection preparation A, characterized in that: The preparation method prepares the active superantigen immune reconstruction compound biological injection preparation A according to any one of claims 1 to 3, comprising the following preparation steps: Superantigens with immunomodulatory activity are screened from natural microorganisms or genetically engineered microorganisms, and high-purity and high-activity superantigens are obtained through fermentation, extraction and purification steps. According to the amino acid ratio described in claim 1, the amino acid raw materials of lysine, arginine, glutamine, cysteine ​​and aspartic acid are weighed and prepared into a uniform amino acid mixture through the steps of dissolving, mixing and adjusting the pH value. Bioactive peptides are obtained from natural proteins by enzymatic or acid-base hydrolysis, or by genetic engineering to synthesize peptide compounds with specific biological activity. The extracted and purified superantigen is chemically bonded to the prepared amino acid mixture to form a stable superantigen-amino acid complex. The bioactive peptide is connected to the superantigen-amino acid complex to form the final active superantigen immune reconstitution compound biological injection preparation A. The prepared preparation A is sterilized and then subjected to quality testing, including purity, activity, sterility testing, and stability testing indicators. If it meets the standards, it is packaged and put into storage.

6. The method for preparing the active superantigen immune reconstitution compound biological injection preparation A according to claim 5, characterized in that: The active superantigen is screened out by high-throughput screening or genetic engineering technology.

7. The method for preparing the active superantigen immune reconstruction compound biological injection preparation A according to claim 5, characterized in that: In the fermentation step, an optimized fermentation medium is used, which contains a carbon source, a nitrogen source, an inorganic salt and a growth factor that are beneficial to the production and accumulation of superantigens, so as to further improve the yield and purity of superantigens.

8. The method for preparing the active superantigen immune reconstitution compound biological injection preparation A according to claim 5, characterized in that: In the sterilization step, a mild sterilization method such as low-temperature and long-term sterilization or irradiation sterilization is used to ensure the sterility of the preparation while retaining the biologically active ingredients and stability in the preparation to the greatest extent.

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