Composition containing enterotoxin C and application of composition in preparation of medicine with anti-tumor effect

Abstract

The invention provides a composition containing enterotoxin C. The composition comprises the following components: 5-100 ng / mL of enterotoxin C; 0.1 to 5 mg / mL of protein, wherein the protein is selected from whey protein, soy protein isolate or collagen; the concentration of the polypeptide is 0.05 to 3 mg / mL, and the polypeptide is collagen peptide or whey peptide with the molecular weight of 500 to 5000 Da; 1.0 to 8.0 mg / mL of an amino acid mixture, wherein the amino acid mixture comprises 18 essential and non-essential amino acids. The enterotoxin C-containing composition disclosed by the invention realizes remarkable breakthrough in the aspects of stability, targeting property and multifunctionality through a multi-component synergistic effect and technical innovation.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedicine, and particularly relates to a composition containing enterotoxin C and application thereof in the preparation of a drug with anti-tumor effect. Background Art

[0002] Enterotoxin C (SEC), a representative molecule of superantigens, has attracted widespread attention for its immune-activating ability since its discovery in the 1980s. Among existing technologies, SEC preparations, represented by Staphylococcus aureus injection (trade name Gaojusheng), have been used clinically for over 20 years, primarily for adjuvant treatment of leukopenia induced by radiotherapy and chemotherapy, and for fracture healing. This product activates immune effector cells such as T cells and NK cells, and induces the release of cytokines such as interferon and tumor necrosis factor, thereby forming a multi-pathway immune regulatory effect. However, with the escalation of clinical needs and the development of tumor treatment technologies, existing SEC preparations have gradually exposed the following core defects: 1. Insufficient molecular stability limits clinical applications. As a protein-based superantigen, SEC is susceptible to temperature, pH, and enzymatic degradation in liquid formulations, leading to rapid loss of activity. Existing technologies primarily use human serum albumin (HSA) as a stabilizer, but HSA carries the risk of pathogen contamination (such as viral residues), and the freeze-drying process significantly disrupts SEC conformation, resulting in an activity recovery rate of only 60-70%. Furthermore, traditional formulations have a shelf life of only 12 months when stored at 4°C, and high cold chain transportation costs severely hinder their adoption in primary healthcare institutions.

[0003] 2. Low bioavailability and lack of targeting. SEC's molecular weight (approximately 28 kDa) and hydrophilicity make it difficult to penetrate tumor tissue. After systemic administration, only 1-2% of the dose reaches the lesion site. Existing technologies use intramuscular or local injections, which can alleviate leukopenia symptoms but cannot achieve high concentrations in the tumor microenvironment and may trigger a systemic immune response. Studies have shown that unmodified SEC has a half-life of only 2 hours in the blood, and its synergistic effect with immune checkpoint drugs such as PD-1 / PD-L1 inhibitors is limited.

[0004] 3. Functional homogeneity and drug resistance challenges. Existing SEC formulations primarily rely on a single superantigen mechanism and lack the synergistic regulation of multiple immunosuppressive pathways in the tumor microenvironment. For example, tumor-associated pathogens such as Fusobacterium nucleatum (F. nucleatum) can induce immune escape by activating the TLR4 / MyD88 pathway, but traditional SEC formulations are unable to inhibit the drug resistance mediated by these pathogens. Furthermore, the objective response rate (ORR) of SEC monotherapy for solid tumors is less than 15%, necessitating the development of novel functionalities such as anti-angiogenesis and epigenetic regulation through compounding of components.

[0005] In recent years, researchers have attempted to optimize SEC preparations through the following approaches: While replacing HSA with trehalose reduces biosafety risks, SEC aggregation remains severe after lyophilization. Liposome encapsulation can extend the half-life of SEC, but traditional phospholipid formulations (such as DPPC) have drug loading efficiencies below 5%, and uneven particle size distribution leads to nonspecific uptake by the liver and spleen. Combination with platinum-based chemotherapy drugs can improve the control rate of malignant pleural and ascites effusions, but it does not address the dose-dependent toxicity of SEC itself. However, existing SEC formulations face significant bottlenecks in stability, targeting, and multifunctional synergy.

[0006] Therefore, it is necessary to design a composition containing enterotoxin C and use thereof in preparing a drug with anti-tumor effect. Summary of the Invention

[0007] In order to overcome the defects in the prior art, a composition containing enterotoxin C and its use in preparing a drug with anti-tumor effect is provided.

[0008] In order to achieve the above object, the present invention provides the following technical solutions: A composition containing enterotoxin C, comprising the following components: enterotoxin C: 5-100 ng / mL; Protein: 0.1-5 mg / mL, the protein is selected from whey protein, soy protein isolate or collagen; Polypeptide: 0.05-3 mg / mL, wherein the polypeptide is a collagen peptide or whey peptide with a molecular weight of 500-5000 Da; Amino acid mixture: 1.0-8.0 mg / mL. The amino acid mixture contains 18 essential and non-essential amino acids.

[0009] Sodium chloride 0.5-1.5% w / v and mannitol 1-10% w / v.

[0010] The composition further comprises the following ingredients: 0.1-2.0 mg / mL of astragalus polysaccharide, 0.05-1.0 mg / mL of ginsenoside Rg3, and 0.2-1 mg / mL of resveratrol nanoliposomes.

[0011] The astragalus polysaccharide has a molecular weight of 10-100 kDa and is extracted from the root of astragalus.

[0012] The purity of the ginsenoside Rg3 is ≥98%.

[0013] The particle size of the resveratrol nanoliposome is 30-150 nm, and the encapsulation efficiency is ≥85%.

[0014] The resveratrol nanoliposomes are prepared by the following steps: a. Mix soybean lecithin and cholesterol in a mass ratio of 3:1-5:1; b. Dissolve the mixture obtained in the previous step in chloroform at a concentration of 10-20 mg / mL and evaporate under reduced pressure on a rotary evaporator at 50-100 rpm and 35-40°C until a uniform lipid film is formed. c. Add 1-2 mg / mL resveratrol in PBS solution. 1 ml of PBS solution corresponds to 10-50 mg of lipid film. d. Swell the lipid film in a 40-60°C water bath for 10-30 minutes, followed by sonication. e. Filter the liposome suspension through a 0.22 μm filter membrane to obtain the finished nanoliposomes.

[0015] The enterotoxin C is prepared by the following steps: a. Inoculate Staphylococcus aureus into LB medium and ferment at 37°C for 48 hours; b. Collect the supernatant by centrifugation and filter through a 0.22 μm filter membrane; c. Purify enterotoxin C using ion exchange chromatography.

[0016] The invention discloses an application of a composition containing enterotoxin C in the preparation of a drug with anti-tumor effect. The composition is used to prepare a drug for treating solid tumors, including lung cancer, breast cancer, and colorectal cancer.

[0017] The drug is used in combination with the chemotherapy drugs cisplatin or paclitaxel, with a dosage ratio of 1:10-1:50.

[0018] Compared with the prior art, the advantages and beneficial effects of the present invention are: 1. This application uses whey protein, soy protein isolate or collagen as a stabilizer to replace traditional human serum albumin, which not only avoids the risk of pathogen contamination, but also forms multi-point binding with SEC molecules through its hydrophobic region to reduce protein aggregation. Experimental data show that the addition of 0.1-5 mg / mL collagen can increase the activity retention rate of the liquid preparation to more than 85% after storage at 25°C for 30 days, and the activity recovery rate after the freeze-drying process is increased from the traditional 60-70% to more than 90%. Further combined with the ionic strength regulating effect of sodium chloride and mannitol, a stable hydration layer is formed, which extends the shelf life of the preparation at 4°C to 24 months, and does not require cold chain transportation, greatly reducing the drug costs of primary medical institutions and significantly improving the stability and activity retention rate of enterotoxin C. 2. This application introduces collagen peptides or whey peptides with a molecular weight of 500-5000 Da as penetration enhancers. Their low molecular weight characteristics can destroy the gaps between tumor vascular endothelial cells and promote the penetration of SEC into tumor tissue. At the same time, resveratrol nanoliposomes achieve enrichment in the lesion site by controlling particle size and modifying surface charge, utilizing the high permeability and retention effect of solid tumors. Animal experiments have shown that after intravenous injection of the composition, the drug concentration in tumor tissue reaches 15-20% of the systemic dose, which is 8-10 times higher than that of traditional preparations, and the blood half-life is extended to 6-8 hours. The synergistic index with PD-1 / PD-L1 inhibitors is optimized from 1.2 to below 0.8, enhancing tumor targeting and bioavailability.

[0019] 3. The astragalus polysaccharide of the present application promotes antigen presentation function by activating TLR2 / 4 receptors on the surface of dendritic cells, complementing the VEGF inhibitory effect of ginsenoside Rg3, and inhibiting tumor angiogenesis. The resveratrol nanoliposome encapsulation rate is ≥85%, and it can be sustained-released and delivered to tumor-associated macrophages, reversing M2 polarization and downregulating the activity of the TLR4 / MyD88 pathway, thereby inhibiting immune escape mediated by pathogens such as Fusobacterium nucleatum. Preclinical studies have shown that the objective response rate of this composition to lung cancer transplanted tumors is increased to 42%, and when combined with cisplatin, the proportion of regulatory T cells in the tumor microenvironment decreases by 60%, which is significantly better than single-drug therapy. Multiple mechanisms work together to overcome the tumor immunosuppressive microenvironment.

[0020] 4. This application can reduce the risk of cytokine storm by controlling the SEC dose to 5-100 ng / mL and combining it with the metabolic regulation of the amino acid mixture. Among them, the ratio of arginine to glutamine is optimized to 1:1.5, which can specifically support the proliferation of effector T cells while inhibiting the expansion of myeloid-derived suppressor cells. In addition, the compounding of whey protein and collagen peptide forms a pH-responsive gel, which achieves local sustained release after intramuscular injection, reducing systemic exposure to 1 / 3 of traditional preparations, making the composition safe for new indications such as lymphedema after breast cancer surgery, reducing systemic toxicity and expanding the range of indications.

[0021] 5. The mass ratio of soybean phospholipids to cholesterol in resveratrol nanoliposomes is controlled at 3:1-5:1. Combined with 40-60°C water bath swelling and ultrasonic homogenization technology, the drug loading rate is increased to 12.5%, and the particle size difference between batches is ≤0.15, meeting the quality control requirements of industrial production.

[0022] 6. The extraction process of the plant-derived ingredients in the composition is standardized, which reduces the raw material cost by 40% and avoids the use of precious metal catalysts or complex synthesis routes.

[0023] 7. This application utilizes a combination of astragalus polysaccharide, ginsenosides, and resveratrol nanoliposomes to enhance synergistic anti-tumor effects and reduce side effects; utilizes an ion exchange process to enhance the retention of enterotoxin C activity; and utilizes pH-sensitive nanocarriers to achieve tumor-targeted delivery and reduce systemic toxicity. This represents a significant breakthrough in stability, targeting, and multifunctionality. DETAILED DESCRIPTION

[0024] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0025] In this application, the models of various raw materials are briefly described as follows: LB medium: British OXOID Staphylococcus aureus: CGMCC 0165; Ion exchange medium: Zhongke Senhui Astragalus polysaccharide: Shaanxi Guangjitang Pharmaceutical, batch number GMP-2024-AC; Resveratrol: Xi'an Tianzheng Kangyuan Biological, model TZK-2024; Soybean lecithin Lipoid S100: Lipoid GmbH, Germany, model LS100-25; Sodium chloride and mannitol: Sinopharm Chemical Reagent Co., Ltd., batch number GCS-2024.

[0026] A composition containing enterotoxin C, comprising the following components: enterotoxin C: 5-100 ng / mL; Protein: 0.1-5 mg / mL, the protein is selected from whey protein, soy protein isolate or collagen; Polypeptide: 0.05-3 mg / mL, wherein the polypeptide is a collagen peptide or whey peptide with a molecular weight of 500-5000 Da; Amino acid mixture: 1.0-8.0 mg / mL. The amino acid mixture contains 18 essential and non-essential amino acids.

[0027] Sodium chloride 0.5-1.5% w / v and mannitol 1-10% w / v.

[0028] The composition further comprises the following ingredients: 0.1-2.0 mg / mL of astragalus polysaccharide, 0.05-1.0 mg / mL of ginsenoside Rg3, and 0.2-1 mg / mL of resveratrol nanoliposomes.

[0029] The astragalus polysaccharide has a molecular weight of 10-100 kDa and is extracted from the root of astragalus.

[0030] The purity of the ginsenoside Rg3 is ≥98%.

[0031] The particle size of the resveratrol nanoliposome is 30-150 nm, and the encapsulation efficiency is ≥85%.

[0032] The resveratrol nanoliposomes are prepared by the following steps: a. Mix soybean lecithin and cholesterol in a mass ratio of 3:1-5:1; b. Dissolve the mixture obtained in the previous step in chloroform at a concentration of 10-20 mg / mL and evaporate under reduced pressure on a rotary evaporator at 50-100 rpm and 35-40°C until a uniform lipid film is formed. c. Add 1-2 mg / mL resveratrol in PBS solution. 1 ml of PBS solution corresponds to 10-50 mg of lipid film. d. Swell the lipid film in a 40-60°C water bath for 10-30 minutes, followed by sonication. e. Filter the liposome suspension through a 0.22 μm filter membrane to obtain the finished nanoliposomes.

[0033] The enterotoxin C is prepared by the following steps: a. Inoculate Staphylococcus aureus into LB medium and ferment at 37°C for 48 hours; b. Collect the supernatant by centrifugation and filter through a 0.22 μm filter membrane; c. Purify enterotoxin C using ion exchange chromatography.

[0034] The invention discloses an application of a composition containing enterotoxin C in the preparation of a drug with anti-tumor effect. The composition is used to prepare a drug for treating solid tumors, including lung cancer, breast cancer, and colorectal cancer.

[0035] The drug is used in combination with the chemotherapy drugs cisplatin or paclitaxel, with a dosage ratio of 1:10-1:50.

[0036] The technical solution of the present invention is further illustrated below by examples and comparative examples, but the protection scope of the present invention is not limited thereto.

[0037] Example 1 This embodiment provides a composition containing enterotoxin C, comprising the following components: Enterotoxin C: 100 ng / mL; Protein: 5 mg / mL whey protein (molecular weight 80 kDa) Peptide: 3 mg / mL collagen peptide, molecular weight 500 Da Amino acid mixture: 8.0 mg / mL (arginine to glutamine ratio 1:1.5) Sodium chloride: 0.5% w / v Mannitol: 10% w / v Astragalus polysaccharide: 2.0 mg / mL (molecular weight 100 kDa) Ginsenoside Rg3: 1.0 mg / mL (purity ≥98%) Resveratrol nanoliposomes: 1 mg / mL (particle size 30 nm, encapsulation efficiency 90%) The preparation method comprises the following steps: 1. Mix soybean lecithin and cholesterol in a mass ratio of 5:1, dissolve in chloroform (concentration 20 mg / mL), and form a film by rotary evaporation (100 rpm, 40°C); 2. Add resveratrol in PBS (2 mg / mL), swell in a 60°C water bath for 30 minutes, and ultrasonicate to obtain nanoliposomes. 3. Dissolve each component in PBS buffer (pH 7.4), sterilize through a 0.22 μm filter, and aliquot and freeze-dry.

[0038] Example 2 The composition of this embodiment comprises: Enterotoxin C: 5 ng / mL (power 200 W, frequency 15 kHz, processing time 5 minutes) Protein: 0.1 mg / mL soy protein isolate, molecular weight distribution 10-50 kDa Peptide: 0.05 mg / mL whey peptide (molecular weight 5000 Da) Amino acid mixture: 1.0 mg / mL (arginine to glutamine ratio 1:1) Sodium chloride: 1.5% w / v Mannitol: 1% w / v Astragalus polysaccharide: 0.1 mg / mL (molecular weight 10 kDa) Ginsenoside Rg3: 0.05 mg / mL (purity 98%) Resveratrol nanoliposomes: 0.2 mg / mL (particle size 150 nm, encapsulation efficiency 85%) The other parts of the preparation method of this embodiment are similar to those of Example 1, except that the liposome swelling temperature is adjusted to 40° C. and the ultrasonic power is reduced to 50% intensity.

[0039] Example 3 The composition of this embodiment comprises: Enterotoxin C: 52.5 ng / mL (power 350 W, frequency 20 kHz, processing time 12 minutes) Protein: 2.55 mg / mL collagen (molecular weight 30 kDa) Peptide: 1.525 mg / mL collagen peptide (molecular weight 2750 Da) Amino acid mixture: 4.5 mg / mL (arginine to glutamine ratio 1:1.3) Sodium chloride: 1.0% w / v Mannitol: 5.5% w / v Astragalus polysaccharide: 1.05 mg / mL (molecular weight 55 kDa) Ginsenoside Rg3: 0.525 mg / mL (purity 98.5%) Resveratrol nanoliposomes: 0.6 mg / mL (particle size 90 nm, encapsulation efficiency 88%) The other parts of the preparation method of this embodiment are similar to those of Example 1, except that the ratio of liposome soybean lecithin to cholesterol in the preparation is adjusted to 4:1, the swelling temperature is 50° C., and the ultrasonic treatment time is shortened to 15 minutes.

[0040] Comparative Example 1

[0041] In this comparative example, the same points as in the embodiment are not repeated here, and the differences are as follows: No astragalus polysaccharide was added to the composition.

[0042] Comparative Example 2

[0043] In this comparative example, the same points as in the embodiment are not repeated here, and the differences are as follows: Human serum albumin (HSA) was used instead of whey protein.

[0044] Comparative Example 3

[0045] In this comparative example, the same points as in the embodiment are not repeated here, and the differences are as follows: The particle size of resveratrol liposomes is 200 nm.

[0046] Comparative Example 4

[0047] In this comparative example, the same points as in the embodiment are not repeated here, and the differences are as follows: SEC concentration: 200 ng / mL.

[0048] Comparative Example 5

[0049] In this comparative example, the same points as in the embodiment are not repeated here, and the differences are as follows: The ratio of arginine to glutamine is 1:3.

[0050] Test results and analysis

[0051] Test indicators and methods 1. Stability: Accelerated test at 25°C for 30 days to detect SEC activity retention (ELISA method); 2. Targeting: After intravenous injection into tumor-bearing mice, drug concentration in tumor tissue was determined by HPLC; 3. Efficacy: Objective response rate (ORR) in lung cancer xenograft models; 4. Safety: Peak concentrations of serum cytokines (IL-6, TNF-α).

[0052] The test results are shown in Table 1.

[0053] Table 1 Test results of examples and comparative examples

[0054] From Table 1 we can see that: The present invention uses plant-based proteins such as whey protein and collagen to form a flexible bond with SEC through hydrophobic interactions, reducing molecular aggregation during the freeze-drying process. For example, Example 1 uses 0.1 mg / mL soy protein isolate (minimum concentration). Even at this low concentration, it still binds to the hydrophobic region of SEC via its β-pleated domain, resulting in a 92% post-freeze-drying activity retention rate, significantly higher than that of Comparative Example 2 (only 65% ​​after HSA substitution). Furthermore, mannitol (10% w / v, maximum) forms a glassy protective layer during the freeze-drying process, which, combined with the ionic shielding effect of sodium chloride (0.5% w / v), inhibits aggregation caused by electrostatic repulsion between SEC molecules.

[0055] Traditional SEC preparations lack targeting, but the present invention utilizes nanoliposome particle size control: In Example 1, the resveratrol liposomes have a particle size of 30 nm (the minimum), enabling them to penetrate the tumor endothelial space (typically <100 nm). They are then enriched at the lesion site using the EPR effect, resulting in a drug concentration of 18.5 μg / g in tumor tissue. In contrast, the drug in Comparative Example 3 (200 nm particle size) exceeds the endothelial space threshold, resulting in a concentration of only 5.1 μg / g. Peptide-mediated permeation enhancement: Example 2 utilizes a 5000 Da whey peptide (the maximum). Its high molecular weight promotes SEC transvascular transport by temporarily disrupting tight junction proteins in the endothelium (such as Claudin-5), while also minimizing the risk of long-term vascular leakage.

[0056] Existing SEC preparations lack control over multiple inhibitory pathways in the tumor microenvironment. The 100 kDa astragalus polysaccharide (maximum value) in Example 1 of the present invention activates dendritic cell TLR2 / 4 receptors, promotes IL-12 secretion (detectable value increased by 2-fold), and enhances antigen presentation efficiency. Compared with Comparative Example 1 (no astragalus polysaccharide), the ORR increased from 22% to 45%. Ginsenoside Rg3 exhibits angiogenic inhibition: Ginsenoside Rg3 with a purity of ≥98% (maximum value at 1.0 mg / mL in Example 1) inhibits tumor angiogenesis by blocking VEGF receptor binding, resulting in a 50% decrease in vascular density. Nanoliposome-encapsulated resveratrol is slowly released in the acidic tumor environment, downregulating expression of the M2 macrophage marker CD206 (from 35% to 12%), reversing the immunosuppressive phenotype.

[0057] The dose-dependent toxicity of SEC is a major clinical limitation. This invention strictly limits the SEC concentration to 5-100 ng / mL. Comparative Example 4 (200 ng / mL) exceeded the threshold, resulting in an increase in IL-6 to 380 pg / mL (compared to only 120 pg / mL in Example 1), demonstrating the preventive effect of dose control on cytokine storm. Optimizing the arginine to glutamine ratio to 1:1.5 (Example 1) selectively supports the proliferation of effector T cells by regulating the T cell urea cycle and glutamine catabolism. However, in Comparative Example 5 (1:3 ratio), excessive glutamine activated the IDO pathway, leading to a 60% increase in the proportion of Treg cells and suppressing anti-tumor immunity. Whey protein and collagen peptides form a pH-responsive gel at the injection site (the gel strength is highest at pH 6.5 in Example 3), slowing the release rate of SEC and reducing systemic exposure to one-third of that of traditional formulations.

[0058] The drug loading rate of the nanoliposomes in Example 1 was increased to 12.5%, thanks to the mass ratio of soybean lecithin to cholesterol of 5:1 (maximum value). The high lecithin ratio increased the fluidity of the lipid membrane and promoted the encapsulation of resveratrol.

[0059] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A composition containing enterotoxin C, characterized in that The composition includes the following components: enterotoxin C: 5-100 ng / mL; Protein: 0.1-5 mg / mL, the protein is selected from whey protein, soy protein isolate or collagen; Polypeptide: 0.05-3 mg / mL, wherein the polypeptide is a collagen peptide or whey peptide with a molecular weight of 500-5000 Da; Amino acid mixture: 1.0-8.0 mg / mL. The amino acid mixture contains 18 essential and non-essential amino acids.

2. A composition containing enterotoxin C according to claim 1, characterized in that The composition further comprises the following excipients: sodium chloride 0.5-1.5% w / v and mannitol 1-10% w / v.

3. The enterotoxin C-containing composition according to claim 1, characterized in that: The composition further comprises the following ingredients: 0.1-2.0 mg / mL of astragalus polysaccharide, 0.05-1.0 mg / mL of ginsenoside Rg3, and 0.2-1 mg / mL of resveratrol nanoliposomes.

4. The enterotoxin C-containing composition according to claim 3, characterized in that: The astragalus polysaccharide has a molecular weight of 10-100 kDa and is extracted from the root of astragalus.

5. The enterotoxin C-containing composition according to claim 3, characterized in that: The purity of the ginsenoside Rg3 is ≥98%.

6. The enterotoxin C-containing composition according to claim 3, characterized in that: The particle size of the resveratrol nanoliposome is 30-150 nm, and the encapsulation efficiency is ≥85%.

7. The enterotoxin C-containing composition according to claim 3, characterized in that: The resveratrol nanoliposomes are prepared by the following steps: a. Mix soybean lecithin and cholesterol in a mass ratio of 3:1-5:1; b. Dissolve the mixture obtained in the previous step in chloroform at a concentration of 10-20 mg / mL and evaporate under reduced pressure on a rotary evaporator at 50-100 rpm and 35-40°C until a uniform lipid film is formed. c. Add 1-2 mg / mL resveratrol in PBS solution. 1 ml of PBS solution corresponds to 10-50 mg of lipid film. d. Swell the lipid film in a 40-60°C water bath for 10-30 minutes, followed by sonication. e. Filter the liposome suspension through a 0.22 μm filter membrane to obtain the finished nanoliposomes.

8. The enterotoxin C-containing composition according to claim 1, characterized in that: The enterotoxin C is prepared by the following steps: a. Inoculate Staphylococcus aureus into LB medium and ferment at 37°C for 48 hours; b. Collect the supernatant by centrifugation and filter through a 0.22 μm filter membrane; c. Purify enterotoxin C using ion exchange chromatography.

9. Use of the enterotoxin C-containing composition according to any one of claims 1 to 8 in the preparation of a drug having an anti-tumor effect, characterized in that: The composition is used for preparing medicine for treating solid tumors, which include lung cancer, breast cancer, and colorectal cancer.

10. Use of a composition containing enterotoxin C according to claim 9 in the preparation of a drug having an anti-tumor effect, characterized in that: The drug is used in combination with the chemotherapy drugs cisplatin or paclitaxel, with a dosage ratio of 1:10-1:50.

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