Polypeptide antigen nanoparticle system based on mesoporous silica as well as preparation method and application of polypeptide antigen nanoparticle system

Abstract

The invention relates to the field of nano-drugs, in particular to a polypeptide antigen nanoparticle system based on mesoporous silica as well as a preparation method and application of the polypeptide antigen nanoparticle system. The nano system comprises polypeptide, mesoporous silica and a lipid material, a compound formed by the polypeptide and the mesoporous silica is loaded in nanoparticles formed by the lipid material, the dosage mass ratio of the polypeptide to the mesoporous silica in the nano system is 1: 5, and the mass concentration of the polypeptide is 1 mg / mL. The preparation method of the polypeptide-loaded mesoporous silica nano system provided by the invention is simple, convenient and rapid. Compared with other nano systems, the polypeptide-loaded mesoporous silica nano system prepared by the preparation method disclosed by the invention has good biocompatibility and relatively high encapsulation efficiency.

Description

Technical Field

[0001] The present invention relates to the field of nanomedicine, and in particular to a polypeptide antigen nanoparticle system based on mesoporous silica and a preparation method and application thereof. Background Art

[0002] Protein drugs can be divided into peptides and genetically engineered drugs, monoclonal antibodies and genetically engineered antibodies, recombinant vaccines, etc. Compared with traditional small molecule drugs, as active substances of various cell functions in organisms, proteins and peptides involve various fields such as hormones, nerves, cell growth and proliferation. Compared with traditional small molecule chemical drugs, protein drugs have good biological activity, strong specificity, low toxicity, clear biological functions, and are conducive to clinical application. They are often effective, have few adverse reactions, are highly safe, and rarely cause serious immune reactions. Therefore, protein peptide drugs have become the first-line drugs for the treatment of various diseases such as endocrine, infectious and metabolic diseases. However, protein peptide drugs have poor stability, are easy to be enzymatically hydrolyzed, have a short biological half-life, and are difficult to pass through biological barriers and lipid membranes, resulting in low bioavailability of such drugs. Therefore, in recent years, some researchers have tried to embed them in carrier models such as microspheres and gels for intramuscular or subcutaneous injection, which can not only prevent the rapid degradation of drugs in the body, but also achieve the purpose of sustained release and long-term effect. Therefore, in view of the shortcomings of protein peptide drugs in drug administration, many technologies have been used to modify peptide drugs or incorporate them into new drug delivery carrier systems to enhance the efficacy of protein peptide drugs.

[0003] The structure of the peptide TRPM8-2 (T2 for short) is shown below. It is the antigenic epitope of the TRPM8 (transient receptor potential cation channel subfamily M member) protein. Its amino acid sequence is CSEEM RHRFR QLDTK LNDLKG, and its molecular weight is 2.58kDa. TRPM8-2 can participate in the regulation of inflammation and cancer. However, as a peptide drug, T2 peptide also faces the same difficulties faced by the above-mentioned peptide drugs in formulation development.

[0004]

[0005] Nanoparticles (NPs) have good modifiability and the ability to load functional drugs, as well as advantages such as large biocompatibility, small size, high bioavailability, and easy functionalization with ligands. They are very conducive to building an integrated nano-diagnosis and treatment platform and have good application value in the field of precision medicine. Therefore, they have been established as a new drug delivery carrier in the field of diagnosis and drug application. According to the different components, nanoparticles are mainly divided into organic and inorganic nanomaterials. Since organic materials have poor stability under various conditions (temperature range, pH value and ion conditions, solubility), with the development of nanotechnology, more and more inorganic materials are applied to nano drug delivery systems. These inorganic materials have high drug loading capacity, good biocompatibility, and are not easy to accumulate in the body, with few side effects, etc., and have high value in new drug delivery systems.

[0006] Due to the poor stability and low encapsulation rate of peptide drugs, how to load and protect peptides and efficiently deliver them to the target site is a difficult problem that needs to be solved urgently in the design and development of peptide drug delivery systems. Summary of the invention

[0007] Purpose of the Invention

[0008] The present invention aims at the instability and enzyme degradation of polypeptide drugs and constructs a mesoporous silica nanocarrier system for efficiently loading polypeptides.

[0009] The present invention constructs a nanocarrier loaded with model polypeptide T2 based on mesoporous silica nanoparticles (MSNs), and encapsulates the nanocarrier with lipids to achieve multiple functions such as loading, protection, and delivery. That is, a polypeptide mesoporous silica nanocarrier system loaded with T2 polypeptide is prepared, and the nanoparticle system can improve the ability of T2 polypeptide to complete transmembrane entry into cells and improve the stability of the polypeptide in vivo.

[0010] Another object of the present invention is to provide a preparation method and application of the above polypeptide-loaded mesoporous silica system.

[0011] Technical Solution

[0012] A mesoporous silica-based T2 polypeptide antigen nanoparticle system, characterized in that it comprises: T2 polypeptide, mesoporous silica, phospholipids, and cholesterol. The T2 polypeptide is physically adsorbed into drug-loaded mesoporous silica nanoparticles, and then coated with lipid materials to prepare polypeptide-loaded lipid mesoporous silica nanoparticles.

[0013] The lipid material is prepared from lipid and cholesterol.

[0014] The mesoporous silica nanoparticles are prepared by the following steps: CTAB, TEOS and ammonia water are dissolved in a deionized water solvent, and mesoporous silica is prepared by a soft template method.

[0015] The required TEOS is 2-8 mL, the amount of ammonia water is 3-12 mL, and the amount of CTAB is 0.25-1 g.

[0016] The magnetic stirring speed in the soft template method is 700-1000rpm and the calcination time is 4-7h.

[0017] The ratio of the T2 peptide to the mesoporous silica is 1:1-5, the mass concentration of the T2 polypeptide is 0.2-1.0 mg / mL, and the amino acid sequence of the polypeptide is: CSEEM RHRFR QLDTK LNDLK G.

[0018] The ratio of cholesterol to phospholipid in the lipid material is 1:3-6, the ultrasonic time is 1-4 minutes, and the ultrasonic power is 100-300W.

[0019] Results: The optimal ratio was: 4 mL of TEOS, 0.5 g of CTAB, 6 mL of ammonia water, 700 rpm of stirring speed, 6 h of calcination time, 5:1 of MSN:T2, 1.0 mg / mL of T2 polypeptide mass concentration, 4:1 of phospholipid to cholesterol mass ratio, 1 min of ultrasonic time, and 200 W of ultrasonic power.

[0020] More specifically:

[0021] The present invention provides a method for preparing a T2 polypeptide antigen nanoparticle system based on mesoporous silica, comprising the following steps:

[0022] Step 1: Take CTAB, TEOS and ammonia water and dissolve them in deionized water solvent, and prepare mesoporous silica by soft template method.

[0023] Step 2: Take T2 polypeptide and mesoporous silica and dissolve them in deionized water solvent, and prepare mesoporous silica nanoparticles loaded with T2 polypeptide by physical adsorption method.

[0024] Step 3: The T2 polypeptide-loaded mesoporous silica nanoparticles obtained in step 1 are mixed with lipid materials through a thin film hydration method to prepare T2 polypeptide-loaded lipid-mesoporous silica nanoparticles.

[0025] As a preferred embodiment, in the above step 1, the amount of CTAB is 0.25-1g; preferably, the amount of CTAB is 0.25-0.75g. The amount of TEOS is 2-8mL; the amount of ammonia water is 3-12mL, preferably, the amount of TEOS is 2-6mL, and the amount of ammonia water is 3-9mL. The speed of magnetic stirring is 700-1000rpm / min, and the calcination time is 4-7h. Preferably, the speed of magnetic stirring is 700-900rpm / min, and the calcination time is 5-7h.

[0026] As a preferred mode, in the above step 2, the time used for magnetic stirring is 40-100 min; preferably, the magnetic stirring speed is 40-80 min. The dosage ratio of the T2 peptide to the mesoporous silica is 1:1-5, and the mass concentration of the T2 polypeptide is 0.2-1.0 mg / mL; preferably, the dosage ratio of the T2 peptide to the mesoporous silica is 1:2-4, and the mass concentration of the T2 polypeptide is 0.6-1.0 mg / mL. Drug-loaded nanoparticles are obtained by magnetic stirring.

[0027] As a preferred method, in the above step three, phospholipids and cholesterol are weighed and dissolved in chloroform, a lipid film is prepared by a thin film hydration method, and a mixed aqueous solution of mesoporous silica and T2 polypeptide is added to the lipid film. The mass ratio of cholesterol to phospholipid is 1:3-6, the ultrasonic time is 1-4min, and the ultrasonic power is 100-300W. The mass ratio of cholesterol to phospholipid is 1:3-6; preferably, the mass ratio of cholesterol to phospholipid is 1:3-5. And / or the mass concentration of mesoporous silica is 1-5mg / mL; preferably, the mass concentration of mesoporous silica is 3-5mg / mL. And / or the mass concentration of T2 polypeptide is 0.2-1.0mg / mL, and lipid-mesoporous silica nanoparticles loaded with T2 polypeptide antigen are obtained.

[0028] As the best process, the method described is characterized in that:

[0029] In step 1, 6 mL of ammonia water, 4 mL of TEOS, 0.5 g of CTAB were added, the stirring speed was 700 rpm, and the calcination time was 6 h;

[0030] In step 2, the magnetic stirring time is 43 min; the ratio of mesoporous silica to T2 polypeptide is 5:1, and the mass concentration of T2 polypeptide is 1 mg / mL;

[0031] In step 3, the mass ratio of phospholipid to cholesterol is 4:1, the ultrasonic time is 1 min, and the ultrasonic power is 200 W.

[0032] The lipid-mesoporous silica nanoparticles loaded with T2 polypeptide antigens with uniform particle size and good PDI can be prepared by the method of the present invention. The system has low toxicity to biological systems, is stable, and has good biocompatibility. It is an ideal drug delivery system.

[0033] The present invention also provides the use of the above-mentioned mesoporous silica-based T2 polypeptide antigen nanoparticle system in pharmaceutical manufacturing. The drug-loaded nanogel system has the potential to treat prostate cancer and / or chronic prostatitis (CP / CPPS) through different administration routes.

[0034] The present invention also provides the above-mentioned T2 polypeptide antigen nanoparticle system based on mesoporous silica, which is suitable for multiple administration routes such as subcutaneous injection, intravenous injection, oral administration, inhalation, etc., and can be further designed into a preparation application with a targeted drug delivery system.

[0035] Beneficial Effects

[0036] The innovation of the present invention lies in: first, the present invention designs and constructs lipid-mesoporous silica nanoparticles loaded with polypeptides, mainly targeting the therapeutic potential of the model polypeptide drug T2 polypeptide and its shortcomings in administration. Through nanocarrier encapsulation and lipid surface modification, the encapsulation rate and drug loading of the polypeptide can be effectively improved; at the same time, the constructed nanocarrier can slowly release the polypeptide, enhance the action time of the polypeptide in the body, and enhance the uptake of the polypeptide by dendritic cells, thereby activating the body's immune response. In addition, the inorganic mesoporous silica used in the present invention has the characteristics of an immune adjuvant, which can protect the polypeptide antigen and then enhance its antigen presenting cells, thereby enhancing the body's immune response; furthermore, the polypeptide-loaded nanocarrier constructed by the present invention, after administration by subcutaneous injection, presents the T2 antigen peptide encapsulated by the nanocarrier to the dendritic cells, thereby completing the immune response. Therefore, the present invention constructs a very promising nanocarrier that can be used in immunotherapy. The details are as follows:

[0037] (1) The preparation method of the polypeptide nanoparticle system provided by the present invention is simple and rapid, and the prepared polypeptide nanoparticle system has a higher encapsulation rate and drug loading than the nano-delivery system in the prior art. The encapsulation rate of the mesoporous silica nanoparticles loaded with T2 polypeptide of the present invention is 87%, and after adding lipid material, the encapsulation rate of the lipid-mesoporous silica nanoparticles loaded with T2 polypeptide can reach 93%.

[0038] (2) The polypeptide nanoparticle system provided by the present invention encapsulates the T2 polypeptide in the pores of the nanoparticles, thereby protecting the T2 polypeptide, improving the stability of the T2 polypeptide, and improving the research and development of various dosage forms of the T2 polypeptide.

[0039] (3) The polypeptide nanoparticle system provided by the present invention has wide applicability and the ability to be further modified. It is suitable for multiple routes of administration such as subcutaneous injection, intravenous injection, oral administration, inhalation, etc., as well as the development of targeted modified drug delivery systems and preparations.

[0040] (4) The polypeptide nanosystem provided by the present invention can significantly activate the body's immune response and is an ideal drug delivery system for treating chronic prostatitis (CP / CPPS) and / or prostate cancer. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The accompanying drawings are used to provide further understanding of the present invention and constitute a part of the specification. They are used to explain the present invention together with the embodiments of the present invention, but do not constitute a limitation of the present invention.

[0042] Figure 1 The single factor formulation optimization results of the blank mesoporous silica nanoparticle system (MSNs), A is the effect of ammonia dosage, B is the effect of TEOS addition, C is the effect of CTAB addition, D is the effect of stirring speed, and E is the effect of calcination time.

[0043] Figure 2 This is the single factor formulation optimization result of T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs), A is T2 concentration screening, B is MSN and T2 ratio screening, C is stirring speed screening, and D is stirring time screening.

[0044] Figure 3 Figure 2 is the response surface diagram and contour diagram of T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs), wherein A is the response surface diagram of MSN:T2 and the mass concentration of T2; B is the contour diagram of MSN:T2 and the mass concentration of T2; C is the response surface diagram of MSN:T2 and stirring time; D is the contour diagram of MSN:T2 and stirring time; E is the response surface diagram of the mass concentration of T2 and stirring time; and F is the contour diagram of the mass concentration of T2 and stirring time.

[0045] Figure 4 This is the single factor formulation optimization result of T2 polypeptide lipid-mesoporous silica nanoparticle system (T2 / LMSNs), where A is the mass ratio of phospholipid to cholesterol, B is the ultrasound time, and C is the ultrasound power.

[0046] Figure 5 Transmission electron microscopy (TEM) images of T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs) (A) and lipid-mesoporous silica nanoparticle system (T2 / LMSNs) (B).

[0047] Figure 6These are stability diagrams of T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs) and lipid-mesoporous silica nanoparticle system (T2 / LMSNs); wherein A is the stability of T2 / MSNs at 4°C, B is the stability of T2 / LMSNs at 4°C, C is the stability of T2 / MSNs at room temperature, and D is the stability of T2 / LMSNs at room temperature.

[0048] Figure 7 In vitro release graphs of T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs) (A) and lipid-mesoporous silica nanoparticle system (T2 / LMSNs) (B) at different pH values ​​(pH 5.0, 6.8, 7.4).

[0049] Figure 8 Specific surface area analysis and pore size analysis of T2 polypeptide and T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs), A is the specific surface area diagram of MSN; B is the pore size distribution diagram of MSN; C is the specific surface area diagram of T2 / LMSNs; D is the pore size distribution diagram of T2 / LMSNs.

[0050] Fig. 9 Results of cytotoxicity experiments.

[0051] Fig.10 Figure 2 shows the cellular uptake ability of primary myeloid-derived dendritic cells (BMDCs) for T2 polypeptide (A) T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs); (B) and lipid-mesoporous silica nanoparticle system (T2 / LMSNs); (C). DETAILED DESCRIPTION

[0052] The present invention will be described in detail below through specific embodiments in conjunction with the accompanying drawings, but the present invention is not limited in any way.

[0053] Example 1: Single factor formulation screening of blank mesoporous silica nanoparticle system (MSNs)

[0054] In this embodiment, a template method was used to prepare blank mesoporous silica nanoparticle system (MSNs). The single factor method was used to evaluate the particle size and polymer dispersity index (PDI). The amount of ammonia water, the amount of TEOS added, the amount of CTAB added, the stirring speed, and the calcination time were studied in turn. The formulation optimization results of MSNs are shown in FIG. Figure 1 The optimal process conditions for MSNs were determined as follows: 6 mL of ammonia, 4 mL of TEOS, 0.5 g of CTAB, 700 rpm of stirring speed, and 6 h of calcination time.

[0055] Example 2: Formulation screening of T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs)

[0056] According to the formulation and process conditions of Example 1, T2 polypeptide was added to prepare a mesoporous silica nanoparticle system loaded with T2 polypeptide (T2 / MSNs). Using the single factor method, with encapsulation efficiency (EE) as the evaluation index, the mass ratio of mesoporous silica to T2 polypeptide, the mass concentration of T2 polypeptide, stirring time and stirring speed were studied in turn, and the single factor formulation optimization results of T2 / MSNs were obtained. Figure 2 .

[0057] The response surface optimization method was used to carry out a three-factor three-level experimental design with the mass ratio of mesoporous silica to T2 polypeptide, the mass concentration of T2 polypeptide and stirring time. The encapsulation efficiency and particle size were used as evaluation indicators to compare different formulations. The experimental parameters and evaluation results are shown in Table 1.

[0058] Table 1 Orthogonal experimental design of prescription combination and encapsulation efficiency determination results

[0059]

[0060] All the prescriptions in this example can obtain nanoparticles with uniform particle size, the particle size of the nanoparticles is controlled within 200 nm, and the PDI is less than 0.3.

[0061] Combined response surface curve Figure 3 As shown, the response surface diagram and contour diagram of the T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs) formulation optimization are shown in Figure 3 . Combined with Design-Expert 13 software, under the condition of setting the maximum encapsulation rate, the optimal prescription was calculated as follows: the ratio of mesoporous silica to T2 polypeptide was 5:1, the mass concentration of T2 polypeptide was 1 mg / mL, and the stirring time was 43 min.

[0062] The optimal formulation was verified by repeated experiments, that is, T2 polypeptide mesoporous silica nanoparticle system (T2 / MSNs) was prepared according to the same experimental conditions as in this example, and its encapsulation efficiency was measured to be 87.25%±0.53%.

[0063] Example 3: Single factor formulation screening of T2 polypeptide lipid-mesoporous silica nanoparticle system (T2 / LMSNs)

[0064] According to the formulation and process conditions of Example 2, lipid materials were added to prepare T2 polypeptide-loaded mesoporous silica nanoparticle system (T2 / LMSNs). The single factor method was used, and the encapsulation efficiency (EE) was used as the evaluation index. The mass ratio of phospholipid to cholesterol, ultrasound time and ultrasound power were studied in turn. The single factor formulation optimization results of (T2 / LMSNs) were obtained as shown in Figure 4 .

[0065] Results: The optimal process was as follows: the mass ratio of phospholipid to cholesterol was 4:1, the ultrasonic time was 1 min, and the ultrasonic power was 200 W.

[0066] Example 4: Characterization of T2 polypeptide-loaded mesoporous silica nanoparticle system (T2 / MSNs) and T2 polypeptide lipid-mesoporous silica nanoparticle system (T2 / LMSNs)

[0067] 1. Transmission electron microscopy (TEM) observation

[0068] Take 10 μL of freshly prepared T2 / MSNs and T2 / LMSNs suspension, vertically drip it onto the copper grid, let it stand for 5-10 minutes, and absorb the excess liquid. Take 2% phosphotungstic acid and drip it onto the copper grid, let it stand for 3-5 minutes, and absorb the excess liquid; add phosphotungstic acid a second time, let it stand for 3-5 minutes, and absorb the excess liquid. When the copper grid is dry, it can be photographed on the machine. The transmission electron microscopy results are shown in Figure 5 TEM shows that the nanoparticles are spherical particles with good dispersion and no aggregation.

[0069] 2. Observation of room temperature stability

[0070] T2 / MSNs and T2 / LMSNs suspensions were prepared according to the prescription, placed at room temperature (25°C) and 4°C, and their particle size and PDI changes were measured for 14 consecutive days. The stability results are shown in Figure 6 As shown in the results, it can be seen that the particle size and PDI did not change significantly, proving that the preparation is stable.

[0071] 3. In vitro drug release performance study

[0072] Take 2 mL of suspension containing fluorescent peptide FITC-T2, FITC-T2 / MSNs and FITC-T2 / LMSNs, place it in a dialysis bag, put it in 20 mL of release medium (pH 5.0, 6.8, 7.4), shake it in a water bath constant temperature shaker (37°C, 100 rpm), take 1 ml of sample at 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, and add 1 ml of the same blank release medium. Use an enzyme marker to measure the content of released peptide FITC-T2, and the release results are shown in Figure 7 ,As the pH decreases, the chemical bonds between particles are destroyed, resulting in increased drug release, and the drug release rate of T2 / LMSNs is slower than that of T2 / MSNs.

[0073] 4. Nitrogen adsorption-desorption (BET) analysis

[0074] Samples T2 and T2 / MSNs were taken and their adsorption / desorption isotherms were determined using a specific surface area analyzer and a pore size comprehensive analyzer. Before the test, all samples were vacuum degassed at 200°C for 12 h, and then nitrogen adsorption / desorption experiments were performed at 77K liquid nitrogen temperature. The BET results are shown in Figure 8 The adsorption / desorption curves of MSN and T2 / LMSNs showed type IV isotherm loops, proving their mesoporous structures.

[0075] Example 5: In vitro evaluation of the effects of T2 polypeptide and T2 polypeptide-loaded mesoporous silica nanoparticle system (T2 / MSNs) and T2 polypeptide lipid-mesoporous silica nanoparticle system (T2 / LMSNs)

[0076] 1. Cytotoxicity Assay

[0077] The CCK-8 method was used to investigate the biocompatibility of T2, T2 / MSNs and T2 / LMSNs on dendritic cells.

[0078] BMDCs were cultured until day 6, and the cells were collected and added to a 96-well culture plate at a cell density of 8 × 10 5 T2 peptides and drug-loaded nanoparticles at different concentrations (10, 50, 100 μg / mL) were added to the well plate, and blank and negative controls were set. Each sample well was set with n=3 and placed in a 37°C, 5% CO2 cell culture incubator for overnight incubation. After the incubation, 15ul of CCK-8 reagent was added to each well and incubated for 1.5-4h. The absorbance was measured at 450nm using an enzyme reader.

[0079] Cell survival rate = (OD experimental group - OD blank group) / (OD negative group - OD blank group) × 100%

[0080] Results: See Fig. 9 Among them, T2 / MSNs and T2 / LMSNs had better activities, and T2 / LMSNs had the best effect.

[0081] 2. Study on uptake of BMDCs

[0082] BMDCs were cultured until day 6, and the cells were collected. Cells were added to a 24-well plate at a density of 1×10 6T2 polypeptide and drug-loaded nanoparticles (20 μg / mL) were added to the well plate and incubated in a 37°C, 5% CO2 cell culture incubator for 2, 4, 6, and 8 h.

[0083] Collect the cells in a 1.5 mL EP tube, centrifuge at 600 g for 10 min, and discard the supernatant.

[0084] The cells were washed twice with PBS, centrifuged at 600 g for 10 min, and the supernatant was discarded.

[0085] Add 300 μL PBS and resuspend for flow cytometry detection.

[0086] Results: Fig.10 As shown, T2 / LMSNs had the best effect and produced a synergistic effect.

Claims

1. A T2 polypeptide antigen nanoparticle system based on mesoporous silica, characterized in that: The invention comprises T2 polypeptide, mesoporous silica, phospholipid and cholesterol; wherein the T2 polypeptide is physically adsorbed into drug-loaded mesoporous silica nanoparticles, and then the lipid material is wrapped to prepare polypeptide-loaded lipid mesoporous silica nanoparticles.

2. The nanoparticle system according to claim 1, characterized in that The mesoporous silica nanoparticles are prepared by the following steps: CTAB, TEOS and ammonia water are dissolved in a deionized water solvent, and mesoporous silica is prepared by a soft template method.

3. The nanoparticle system according to claim 2, characterized in that The required TEOS is 2-8 mL, the amount of ammonia water is 3-12 mL, and the amount of CTAB is 0.25-1 g; in the soft template method, the magnetic stirring speed is 700-1000 rpm, and the calcination time is 4-7 h.

4. The nanoparticle system according to claim 1, characterized in that The dosage ratio of the T2 peptide to the mesoporous silica is 1:1-5, the mass concentration of the T2 polypeptide is 0.2-1.0 mg / mL; the mass ratio of cholesterol to phospholipid in the lipid material is 1:3-6; the amino acid sequence of the polypeptide is T2 polypeptide: CSEEM RHRFR QLDTK LNDLK G.

5. The mesoporous silica-based T2 polypeptide antigen nanoparticle system according to claim 1, characterized in that: To do this, follow these steps: Step 1: dissolving CTAB, TEOS and ammonia in deionized water solvent, and preparing mesoporous silica by a soft template method; Step 2: dissolving T2 polypeptide and mesoporous silica in a deionized water solvent, and preparing mesoporous silica nanoparticles loaded with T2 polypeptide by physical adsorption; Step 3: The T2 polypeptide-loaded mesoporous silica nanoparticles obtained in step 1 are mixed with lipid materials through a thin film hydration method to prepare T2 polypeptide-loaded lipid-mesoporous silica nanoparticles.

6. The method according to claim 4, characterized in that In step 1, the amount of CTAB is 0.25-1 g; the amount of TEOS is 2-8 mL; the amount of ammonia water is 3-12 mL; the speed of magnetic stirring is 700-1000 rpm / min, and the calcination time is 4-7 h; In step 2, the magnetic stirring time is 40-100 min; the ratio of the T2 peptide to the mesoporous silica is 1:1-5, and the mass concentration of the T2 polypeptide is 0.2-1.0 mg / mL; In step three, phospholipids and cholesterol are weighed and dissolved in chloroform, a lipid film is prepared by a thin film hydration method, and a mixed aqueous solution of mesoporous silica and T2 polypeptide is added to the lipid film; the mass ratio of cholesterol to phospholipid is 1:3-6, the ultrasonic time is 1-4 min, and the ultrasonic power is 100-300 W; the mass concentration of mesoporous silica is 1-5 mg / mL; the mass concentration of T2 polypeptide is 0.2-1.0 mg / mL.

7. The method according to claim 4, characterized in that In step 1, 6 mL of ammonia water, 4 mL of TEOS, 0.5 g of CTAB were added, the stirring speed was 700 rpm, and the calcination time was 6 h; In step 2, the magnetic stirring time is 43 min; the ratio of mesoporous silica to T2 polypeptide is 5:1, and the mass concentration of T2 polypeptide is 1 mg / mL; In step 3, the mass ratio of phospholipid to cholesterol is 4:1, the ultrasonic time is 1 min, and the ultrasonic power is 200 W.

8. Use of the polypeptide lipid nanosystem according to any one of claims 1 to 3 in the preparation of a medicament for treating chronic prostatitis or prostate cancer.

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