Alcohol-soluble functional system based on dynamic supramolecular assembly as well as preparation method and application of alcohol-soluble functional system

Abstract

The invention provides an alcohol-soluble functional system based on dynamic supramolecular assembly as well as a preparation method and application of the alcohol-soluble functional system. The system is treated in an alcohol-soluble medium with the alcoholic strength of 35% vol to 65% vol through a pressure difference suspension vibration type intelligent regulation and control reactor, so that functional active ingredients, polysaccharide, metal ions and polyphenol are subjected to synergistic coordination and self-assembly. The system simultaneously meets the core characteristics: (1) chemical fingerprints: the molar ratio of Cu < 2 + > to Sr < 2 + > is 6.0: 1-15.0: 1; (2) physical property fingerprints: macroscopic long-term stability is realized, and the polydispersity index (PDI) is obviously higher than that of an untreated control system due to a multistage ordered assembly structure; (3) functional fingerprints: the apparent solubility of functional active ingredients is improved by more than or equal to 50%, and the 2-hour dissolution rate in simulated intestinal juice is more than or equal to 90%. The system solves the technical problem that the stability and bioavailability of an alcohol-soluble product cannot be achieved at the same time, and can be used for preparing functional products for resisting fatigue and enhancing immunity.

Description

Technical Field

[0001] This invention relates to the field of health food and traditional Chinese medicine preparation technology, specifically to a dynamic assembly of nanoparticles constructed by physical field programming in an alcohol-soluble medium, its green preparation method, and its application in the preparation of functional products with high bioavailability and high stability. Background Technology

[0002] High-end medicinal and edible raw materials, such as Cordyceps sinensis, prickly pear, and deer antler from Guangdong, are ideal resources for developing health supplements. Currently, the mainstream process for preparing alcohol-soluble products (such as health wines) from these raw materials is still the traditional static soaking method. This method suffers from two fundamental technical bottlenecks: First, poor physical stability. Large molecules such as proteins, polysaccharides, and polyphenols in the raw materials have poor compatibility in alcohol solutions, easily agglomerating and precipitating, leading to turbidity, precipitation, or even stratification during storage, severely affecting shelf life, appearance, and consumer acceptance. Second, low bioavailability. Static soaking makes it difficult to fully break down cell walls and release intracellular active ingredients (such as cordycepin), and the released functional components exist mostly in a free or simple physical mixture state in the alcohol solution, lacking protection. In the gastrointestinal environment after oral administration, they are easily inactivated or degraded by pH and enzymatic hydrolysis, resulting in limited absorption and insufficient efficacy.

[0003] To address these issues, existing technologies often employ conventional physical pretreatment methods such as high-pressure homogenization and ultrasonic disruption. While these methods can improve the initial homogeneity of the system and the solubility of some components, their energy input patterns are coarse and cannot guide the functional components and matrix components to undergo directional and stable intermolecular interactions in the unique environment of an alcohol-soluble medium. Therefore, they cannot fundamentally construct a microstructure that can maintain long-term stability and intelligently respond to the intestinal environment to achieve efficient release.

[0004] A deeper industry-wide technological bias lies in two aspects: First, there is a widespread belief that high-concentration alcohol environments disrupt the hydration layer and higher-order structures of biomolecules, weakening interactions such as hydrogen bonds, thus hindering the self-assembly and long-term stability of complex, ordered supramolecular structures. This has led to research and development approaches being limited to "fragmentation" and "dispersion" rather than "assembly" and "construction." Second, in the intensive processing of plants such as prickly pear, the resulting pomace is often regarded as a low-value byproduct or waste, while its enormous potential value as a unique repository of metal ions (especially strontium and copper) and polyphenols is severely overlooked.

[0005] Therefore, transforming prickly pear pomace, a traditional low-value byproduct, into a key active ingredient necessary for constructing a highly stable and bioavailable alcohol-soluble functional system is itself a previously unrecognized technological breakthrough with significant creative and economic value. Developing an innovative system and preparation method that can simultaneously and thoroughly solve the two core challenges of "long-term macroscopic stability" and "highly efficient bioavailability of functional components" in alcohol-soluble health products is a long-standing and unresolved technological need in this field.

[0006] Therefore, there is an urgent need in this field for an innovative system and preparation method that can simultaneously improve the macroscopic stability of alcohol-soluble products and the bioavailability of functional components. Summary of the Invention

[0007] This invention aims to overcome the shortcomings of existing technologies and provide a novel dynamic supramolecular assembly alcohol-soluble functional system and its preparation method. This system aims to simultaneously and significantly improve the long-term physical stability of alcohol-soluble products and the oral bioavailability of functional active ingredients, creating a technological barrier that is difficult to replicate.

[0008] The technical solution provided by this invention is defined by the following interrelated 'triple fingerprints': In a first aspect, the present invention provides a dynamic supramolecular assembly alcohol-soluble functional system. This system is a dynamic assembly of nanoparticles formed by the synergistic coordination and self-assembly of functional active ingredients, polysaccharides, metal ions, and plant polyphenols in an alcohol-soluble medium with an alcohol content of 35% vol to 65% vol through specific physical field programming treatment. The system is strictly defined by the following three measurable fingerprints and simultaneously satisfies the following conditions: (a) Characteristic chemical fingerprint: Key metal ions in the system (e.g., Cu) 2+ With Sr 2+ It exhibits a specific molar ratio range (6.0:1 to 15.0:1). This ratio is a macroscopic manifestation and chemical scale of the dynamic coordination equilibrium achieved by multi-component components under specific physical field programming.

[0009] (b) Dynamic physical property fingerprint: The system remained macroscopically uniform and stable after being sealed and stood at 15-25℃ for 30 days. Due to its multi-level ordered assembly structure, the intensity-weighted polydispersity index (PDI) measured by dynamic light scattering (DLS) was significantly higher than that of the control system with the same composition but without the physical field programming treatment, and its PDI value was not less than 35%.

[0010] The system's ability to maintain macroscopic uniformity and stability after being sealed and left to stand at 15-25℃ for 30 days stems from its multi-level mesoscopic structure, which is formed by the self-assembly of nanoparticles and has a "dust-like" surface topology and an internal "sponge-like" three-dimensional network.

[0011] (c) Functional transition fingerprint: The performance of the core functional active ingredient (such as cordycepin) undergoes a qualitative change. Compared with the control system without the physical field programming treatment, its apparent solubility in alcohol-soluble media is significantly improved (≥50%), and its release in a simulated intestinal environment (pH 6.8) is rapid and complete (dissolution rate ≥90% in 2 hours), marking its transformation from a physically dispersed state that is easy to aggregate and difficult to dissolve to a supramolecular complex state that is easy to deliver and absorb.

[0012] Furthermore, after the system is processed by physical field programming, its Zeta potential undergoes regular dynamic evolution. During the subsequent static incubation process at 15-25℃, the change in its Zeta potential value is not less than 30% of the initial absolute value. If the initial value is negative, the absolute value is taken.

[0013] Furthermore, the functional active ingredient is cordycepin, and the plant polyphenols include protocatechuic acid and / or ellagic acid derived from prickly pear pomace.

[0014] Furthermore, by ultraviolet-visible spectroscopy, the characteristic absorption peak of cordycepin in the system was found to be shifted by at least 5 nm compared to the cordycepin standard.

[0015] Furthermore, the dynamic rheological frequency spectrum of the system, measured by a rotational rheometer at 25°C, showed that its loss modulus (G'') was always greater than its storage modulus (G'), and its zero-shear viscosity was at least an order of magnitude higher than that of the control system with the same composition but without physical field programming treatment.

[0016] Furthermore, the multi-level ordered assembly structure exhibits at least one of the following characteristics in its microstructure: (i) It has a "dune-like" surface topology; (ii) Its interior contains a “sponge-like” three-dimensional network structure formed by the self-assembly of nanoparticles.

[0017] Secondly, a method for preparing the aforementioned dynamic supramolecular assembly alcohol-soluble functional system is provided. The key lies in inducing initial assembly through physical field programming with specific parameters (P1, ΔP), and a sufficient settling period (≥15 days) is required to achieve dynamic equilibrium and stabilization of the system. This method includes the following steps: (a) Provide raw materials: Provide natural raw material alcohol extracts containing metal ions and plant polyphenols, as well as raw materials containing functional active ingredients; (b) Forming a liquid: The raw materials from step (a) are dispersed or dissolved in an alcohol solution with an alcohol content of 35% vol to 65% vol to form a composite liquid; (c) Induced dynamic coordination assembly: The composite liquid is subjected to physical field programming treatment using a differential pressure suspension vibration intelligent control reactor. The reactor is configured to establish and maintain a net driving pressure difference (ΔP) by synergistically controlling the feed pressure (P1) and back pressure (P2); the feed pressure P1 is controlled within the range of 50 MPa to 200 MPa, and the treatment is performed 1 to 3 times. (d) Stabilization: The liquid treated in step (c) is sealed and allowed to stand at 15-25°C for at least 15 days. This step is crucial to ensuring that the system reaches final dynamic equilibrium and obtains the "triple fingerprint" characteristics.

[0018] Furthermore, in step (c), the net driving pressure difference ΔP is controlled within the range of 8-25 MPa; and / or, the natural raw material alcohol extract in step (a) is prickly pear pomace alcohol extract, and the raw material containing functional active ingredients is Cordyceps sinensis.

[0019] Thirdly, providing alcohol-soluble health products that include the above-mentioned dynamic supramolecular assembly alcohol-soluble functional system or the dynamic supramolecular assembly alcohol-soluble functional system prepared by the above-mentioned method, such as health wine with a specific alcohol content.

[0020] Furthermore, the product is a health tonic with an alcohol content of 35% vol to 65% vol.

[0021] Fourthly, the use of the above-mentioned dynamic supramolecular assembly alcohol-soluble functional system or alcohol-soluble health products in the preparation of anti-fatigue and / or immune-enhancing preparations is provided.

[0022] Beneficial effects Compared with the prior art, the technical solution provided by the present invention has the following significant advantages: 1. A breakthrough was achieved in constructing ordered assembly structures in alcohol-soluble media: For the first time, a dynamic assembly of nanoparticles with a "dust-like" mesoscopic topological structure was successfully induced and constructed in an alcohol-soluble medium using physical field programming. This breakthrough overcame the traditional technical view that "alcohol environment inhibits ordered interactions" and established a new material state that combines macroscopic homogeneity with microscopic extreme polydispersion.

[0023] 2. Simultaneously improved product stability and bioavailability: Solved the technical challenge of achieving both "long-term stability" and "efficient release" in alcohol-soluble products. The product's shelf life was significantly extended, while the bioavailability of functional components was significantly improved.

[0024] 3. Structural innovation: The system of this invention exhibits a unique four-level assembly structure of "nanoparticles → jujube-shaped units → sponge-like network → dune-like surface". This multi-level ordered assembly not only ensures macroscopic stability, but also creates rich interface and pore structures, providing an ideal carrier platform for the efficient delivery of functional components.

[0025] 4. Theoretical Depth and Evidence Loop: Through the strong correlation and mutual corroboration among the "characteristic chemical fingerprint (specific Cu / Sr ratio)," "dynamic property fingerprint (especially the significantly higher PDI characteristic derived from multi-level structures than the control)," and "functional fingerprint (significantly improved solubility and dissolution rate)," a multi-dimensional and solid chain of evidence is provided for the supramolecular assembly nature of the system, forming a rigorous scientific logical loop. The high and stable polydispersity index (PDI) exhibited by the system is a natural reflection of its internal multi-scale, multi-level ordered assembly structure. This characteristic indicates that macroscopic homogeneity and stability and microscopic polydispersity are unified in the system of this invention, providing a new perspective and valuable examples for resolving the contradiction between the stability and functional delivery of alcohol-soluble systems in traditional understanding.

[0026] 5. High Technical Barriers: Successful preparation of this system highly depends on specific parameter windows for "physical field programming" and the necessary "static ripening" process. The process is complex and difficult to reverse engineer, thus constructing a solid technical barrier. In particular, the composite physical field frequency generated by the differential pressure suspension vibration intelligent control reactor of this invention is much higher than that of traditional high-pressure homogenizers (usually less than 1 Hz), resulting in an order-of-magnitude increase in energy input efficiency. This allows for sufficient self-assembly to be achieved in only 1-3 processing cycles under the same pressure conditions, significantly reducing energy consumption and time costs in industrial production.

[0027] 6. High-value utilization of resources: Traditional by-products such as prickly pear pomace are identified and transformed into key raw materials rich in specific metals and polyphenols that are indispensable for the construction of this system, thus realizing the high-value utilization of resources. Attached Figure Description

[0028] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0029] Figure 1 A schematic diagram comparing the dynamic supramolecular assembly alcohol-soluble functional system provided by this invention with the traditional soaking-dispersion technical solution of reference standards. Figure 2Verification diagram of the characteristic chemical fingerprint (Cu / Sr molar ratio) of the dynamic supramolecular assembly alcohol-soluble functional system provided by the present invention; Figure 3 A stability comparison diagram of the dynamic supramolecular assembly alcohol-soluble functional system provided by this invention and a reference standard; Figure 4 SEM images of the dynamic supramolecular assembly alcohol-soluble functional system and reference standard provided by this invention, where a is the "dust-like" surface morphology of the S-10 sample (SEM, 30x), b is the "sponge-like" network structure inside the S-10 sample; and c is an enlarged view of the "sponge-like" network structure. Figure 5 A comparison chart of the polydispersity index (PDI) of the dynamic supramolecular assembly alcohol-soluble functional system provided by this invention and the reference standard; Figure 6 Zeta potential evolution curves of the dynamic supramolecular assembly alcohol-soluble functional system provided by this invention; Figure 7 UV-Vis spectrum of the dynamic supramolecular assembly alcohol-soluble functional system provided by the present invention; Figure 8 The cumulative dissolution curve of cordycepin in in vitro simulated intestinal fluid for the dynamic supramolecular assembly alcohol-soluble functional system provided by the present invention; Figure 9 Dynamic rheological frequency scanning spectrum of the dynamic supramolecular assembly alcohol-soluble functional system provided by the present invention; Figure 10 The results of the verification of the anti-fatigue efficacy of the dynamic supramolecular assembly alcohol-soluble functional system provided by the present invention; Figure 11 The results of the verification of the immune-enhancing efficacy of the dynamic supramolecular assembly alcohol-soluble functional system provided by the present invention; Figure 12 The flowchart illustrates the preparation process of the dynamic supramolecular assembly alcohol-soluble functional group provided by this invention. Detailed Implementation

[0030] Unless otherwise defined herein, the scientific and technical terms used in conjunction with this invention shall have the meanings commonly understood by one of ordinary skill in the art. The meaning and scope of terms shall be clear; however, in any case of potential ambiguity, the definitions provided herein shall prevail over any dictionary or foreign definitions. In this application, unless otherwise stated, the use of "or" means "and / or". Furthermore, the use of the term "comprising" and other forms is non-limiting.

[0031] Unless otherwise stated, the methods and techniques of the present invention are generally carried out according to conventional methods well known in the art and as described in various general and more specific references, which are cited and discussed throughout this specification.

[0032] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0033] This invention employs a "physical field programming" strategy. This strategy utilizes a specific "differential pressure suspension vibration-type intelligent control reactor" (also known as a differential pressure suspension vibration-type physical field programming reactor, whose working principle is as follows) Figure 1 As shown, under the synergistic control of a specific feed pressure (P1) and net driving pressure difference (ΔP), a programmable composite physical field (such as synergistic cavitation, shearing, and oscillation effects) can be applied to complex systems. In this invention, we creatively apply this strategy to alcohol-soluble media (35-65% vol) with vastly different physicochemical properties, aiming to guide the directional synergistic coordination and self-assembly of functional active ingredients, polysaccharides, metal ions, and polyphenols, thereby solving the core technical challenge of the incompatibility between long-term stability and bioavailability of alcohol-soluble products.

[0034] Through systematic multi-scale characterization, it was discovered that using specific physical field programming techniques to process alcohol-soluble composite systems can guide structural phase transitions. Scanning electron microscopy (SEM) macroscopic observations confirmed that this invention successfully created a novel mesoscopic structure with a uniform "dune-like" topological morphology, formed by the self-assembly of nanoparticles. This structure fundamentally alters the physical properties of the system, endowing it with both macroscopic long-term stability and microscopic extreme complexity, providing a novel material basis for simultaneously solving the challenges of stability and delivery.

[0035] It should be noted that the functional active ingredients described in this invention are not limited to cordycepin, but can also be other ginsenosides (such as Rg3), curcumin, and other active substances with a certain degree of solubility in an alcohol-soluble medium; the plant polyphenols are not limited to the prickly pear pomace, but can also be alcohol extracts of plant raw materials rich in polyphenols and specific metal ions, such as grape seed extract and tea extract. This embodiment uses cordycepin and prickly pear pomace as examples to demonstrate the feasibility of the present invention.

[0036] Example 1: Preparation of dynamic supramolecular assembly alcohol-soluble functional system and verification of "triple fingerprint" system This embodiment aims to demonstrate how to create the system using the method of the present invention and to systematically verify the "triple fingerprint" that it must possess simultaneously.

[0037] 1. Raw materials and preparation raw material: Guangdong Cordyceps Micronized Powder: Its core active ingredient is cordycepin. According to the test report (No. NACCBS23014668) from the Guangdong Academy of Sciences Testing and Analysis Institute (Zhongguangce), the cordycepin content in this raw material is 31.06 g / kg.

[0038] Prickly pear pomace freeze-dried powder: as a building block for the system 2+ Cu 2+ It is a core raw material for polyphenols. According to the CTI (China Testing and Research Institute) report, this raw material is rich in characteristic components: strontium (Sr) content is 9.34 mg / kg; tannin content is as high as 59.7 g / kg; and total flavonoid content is 5.28 g / 100g, confirming that it is a rich source of polyphenols.

[0039] Alcohol-soluble medium: 53% vol Maotai-flavor liquor.

[0040] Preparation instructions: The above-mentioned freeze-dried prickly pear pomace powder was extracted with 50-65% vol edible ethanol to prepare prickly pear pomace ethanol extract, which was used for the preparation of subsequent compound liquid.

[0041] Preparation process: (a) Mixing: Add cordyceps powder and prickly pear pomace alcohol extract to the liquor in proportion and stir to pre-disperse.

[0042] (b) Physical field programming-induced assembly: The composite feed solution is treated using a differential pressure suspension vibration intelligent control reactor. Key process parameters are set and stabilized: feed pressure P1 = 150 MPa (±5 MPa), net driving pressure difference ΔP = 15 MPa (±2 MPa), and the process is repeated twice (N=2). Within the preferred parameter range of this invention, sufficient self-assembly is typically achieved in only 1 to 3 processing cycles, thanks to the extremely high energy efficiency brought by its high-frequency physical field. The feed solution temperature is controlled throughout the process.

[0043] (c) Stabilization: The treated solution was transferred to a clean container and sealed and allowed to stand in the dark at (18±2)°C for 35 days to obtain the final product, denoted as S-10. Stabilization (≥15 days) after treatment is an indispensable key step for the system to reach final dynamic equilibrium, obtain excellent long-term stability, and achieve a complete triple fingerprint. Experiments show that a standing time of at least 15 days is required for the system to reach the stable state of the aforementioned triple fingerprint.

[0044] Preparation of reference standard: Using the same raw materials and proportions as S-10, but without the physical field programming treatment in step (b), the sample was statically soaked at room temperature for 30 days under the same conditions. The resulting sample was recorded as S-09.

[0045] Comparison of the traditional reference standard method with the physical field programming-dynamic assembly technical solution of this invention, for example Figure 1 As shown, Figure 1 The left side shows the traditional passive "soak-dispersion" mode: the raw materials are simply leached and dispersed in alcohol, eventually forming an unstable mixture that is prone to precipitation. Figure 1 The right side illustrates the active mode of this invention's "physical field programming-dynamic assembly": Under the drive of a specific physical field (labeled with parameters P1 and ΔP), the raw materials undergo coordination, cross-linking, and self-assembly, ultimately forming a macroscopically uniform dynamic assembly of nanoparticles with a "dust-like" mesoscopic structure. The preparation process is as follows: Figure 12 As shown.

[0046] 2. Characterization results of "triple fingerprint" (a) Characteristic chemical fingerprint: The content of key metal ions in S-10 was determined by inductively coupled plasma mass spectrometry (ICP-MS). For example... Figure 2 As shown, Cu in S-01 2+ / Sr 2+ The molar ratio is 1.69:1, Cu in S-10 2+ / Sr 2+ The molar ratio is 8.60:1, a value that stably falls within the range of 6.0:1 to 15.0:1 protected by this invention. Figure 2 (Medium gray area). The formation of this specific ratio is the result of selective coordination and dynamic equilibrium between endogenous metal ions and polyphenols / polysaccharides driven by physical field programming.

[0047] (b) Dynamic physical property fingerprint: Multi-scale structural morphology: Multi-scale scanning electron microscopy observations were performed on the S-10 sample. Macroscopically, as shown... Figure 3 As shown, S-10 remained clear and transparent after 30 days of standing, with no visible sediment or stratification, while the reference standard S-09 showed a large amount of sediment. The microstructure is as follows: Figure 4 As shown, the S-10 surface forms a uniform "dust-like" substrate structure, beneath which lies a dense and ordered "sponge-like" three-dimensional network. This network is further assembled from "jujube-shaped" structural units, which are composed of self-assembled nanoparticles with a particle size distribution of 383-969 nm. This multi-level ordered assembly structure, from nanoparticles (basic building blocks) to "jujube-shaped" units, then to the "sponge-like" network, and finally to the "dust-like" surface, is the material basis for its long-term macroscopic stability and the structural source of its combination of macroscopic homogeneity and microscopic polydispersity.

[0048] like Figure 5 and Figure 6The figure shows the dynamic evolution of the solution behavior: the hydrodynamic properties of S-10 were tracked and monitored using a dynamic light scattering (DLS) instrument. Its intensity-weighted polydispersity index (PDI) remained at a high level after static stabilization, reaching over 35% (e.g., ...). Figure 5 As shown in the figure, the PDI value is significantly higher than that of conventionally simple dispersed colloidal systems, and also significantly higher than that of the reference standard S-09, which is a direct manifestation of the existence of a multi-scale, multi-level ordered assembly structure within it. The synchronously monitored Zeta potential evolved systematically from an initial +12.66 mV after resting (e.g., ...). Figure 6 The potential change confirms its nature as a "dynamic assembly".

[0049] (c) Functional transition fingerprint: Improved solubility: The apparent solubility of cordycepin in S-10 in alcohol-soluble medium was measured and found to be about 65% higher than that of the reference standard S-09, meeting the requirement of "improvement of not less than 50%".

[0050] Intelligent release behavior: In vitro dissolution experiments were conducted using simulated intestinal fluid (pH 6.8). Results are as follows: Figure 8 As shown, the cumulative dissolution rate of cordycepin in S-10 after 2 hours is as high as 92.5%, while that in S-09 is only 68.3%, with a highly significant difference (p<0.001), which fully meets the requirement of "dissolution rate not less than 90%" in (c) of this invention.

[0051] Evidence of spectral interactions: Ultraviolet-Vis (UV-Vis) spectral analysis shows (e.g.) Figure 7 As shown in the figure, the characteristic absorption peak of cordycepin in S-10 showed a significant red shift (shift > 5 nm) compared to the cordycepin standard and cordycepin in S-09, which directly confirmed that cordycepin had a coordination interaction with the metal ions / polyphenols in the system, which is the molecular basis for its functional transition.

[0052] (d) Rheological evidence: such as Figure 9 As shown, measurements were taken using a rotational rheometer at 25°C. The dynamic frequency sweep spectrum of S-10 exhibits viscous liquid behavior, with the loss modulus (G'') consistently greater than the storage modulus (G'), and its zero-shear viscosity is nearly two orders of magnitude higher than that of S-09. This strongly demonstrates the formation of a significant dynamic structural network within the system, maintained by supramolecular forces.

[0053] Conclusion: The sample S-10 successfully prepared in this embodiment exhibits characteristic chemical fingerprints (Cu / Sr ratio 8.60:1), dynamic physical property fingerprints (PDI significantly higher than the control with a typical value not less than 35%), and functional transition fingerprints (65% increase in solubility / 92.5% dissolution rate), all of which were rigorously verified by experimental data. Therefore, S-10 simultaneously satisfies all conditions (a), (b), and (c) specified in this invention, successfully constituting the dynamic supramolecular assembly alcohol-soluble functional system described in this invention.

[0054] Example 2: Verification of the necessity of the "static stabilization" step This embodiment aims to verify the indispensability of the "static stabilization" step in the preparation of dynamic supramolecular assembly alcohol-soluble functional systems for achieving the system's performance targets.

[0055] The "instant sample" taken immediately after the physical field programming process in Example 1 was compared with the final product S-10 after 35 days of settling for parallel testing.

[0056] result: Functional performance: The dissolution rate of cordycepin in simulated intestinal fluid of the immediate sample was 78.5% after 2 hours, which was significantly lower than the 92.5% of S-10 after standing.

[0057] Physical stability: Immediate samples showed flocculent suspension within one week of being stored at room temperature, while S-10 remained homogeneous and clear throughout the observation period.

[0058] Rheological properties: The zero-shear viscosity of the instantaneous sample is significantly lower than that of S-10.

[0059] Conclusion: This comparative experiment demonstrates that the static stabilization step (≥15 days) is an essential key process step to ensure that the final product meets the triple fingerprint standard, especially to achieve functional transition fingerprint (high dissolution rate) and dynamic physical property fingerprint (macroscopic stability).

[0060] Example 3: Product Efficacy Verification Based on S-10 (the product of this invention) and S-09 (the conventional control) prepared in Example 1, standardized animal experiments were conducted to verify their claimed functions.

[0061] Fatigue resistance experiment: A mouse weight-bearing swimming model was used. Results are as follows: Figure 10 As shown, mice given S-10 by gavage exhibited a significantly prolonged weight-bearing swimming time, which was significantly better than that of the S-09 group (p<0.001). This efficacy is directly related to the efficient delivery (high dissolution rate) of cordycepin.

[0062] Immunostimulation experiment: An immunosuppressed mouse model was used to measure indicators such as the macrophage phagocytic index. Results are as follows: Figure 11As shown, S-10 significantly increased the macrophage phagocytic index and improved the immune organ index in immunosuppressed mice, with better results than the S-09 group (p<0.01).

[0063] Conclusion: The system (S-10) of this invention shows clear and significant effects in both anti-fatigue and immune enhancement, verifying its application value as a functional raw material.

[0064] Comparative analysis and summary: Traditional static soaking products (S-09) fail to meet the requirements of this invention in all core dimensions: their chemical fingerprint (Cu / Sr ratio) has no specific pattern; their dynamic properties (rapid precipitation, no "dust-like" multi-level structure, low PDI, and irregular potential evolution) are not met; their functional performance (low solubility and dissolution rate) is insufficient; and their final animal efficacy is relatively weak.

[0065] In summary, only by combining the specific physical field programming method described in this invention (especially using a high-frequency composite physical field, requiring only 1-3 processing cycles) with a complete static curing process can a dynamic supramolecular assembly alcohol-soluble functional system possessing both "triple fingerprint" characteristics, a unique multi-level mesoscopic structure, and superior performance be obtained. The absence or deviation of any single condition will prevent the achievement of the technical effects of this invention.

[0066] This invention provides a new and solid scientific foundation and technical solution for the development of alcohol-soluble functional products, and has significant prospects for industrial application.

[0067] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A dynamic supramolecular assembly alcohol-soluble functional system, characterized in that, The system is a dynamic assembly of nanoparticles formed by the synergistic coordination and self-assembly of functional active ingredients, polysaccharides, metal ions, and plant polyphenols in an alcohol-soluble medium with an alcohol content of 35% vol to 65% vol through physical field programming. The system simultaneously satisfies the following conditions: (a) Possesses a characteristic chemical fingerprint: the system contains copper ions (Cu) 2+ ) and strontium ions (Sr) 2+ The molar ratio of () is 6.0:1 to 15.0:1; (b) Exhibits dynamic physical property fingerprints: The system remains macroscopically uniform and stable after being sealed and left to stand at 15-25℃ for 30 days. Due to its multi-level ordered assembly structure, the intensity-weighted polydispersity index (PDI) measured by dynamic light scattering (DLS) is significantly higher than that of the control system with the same composition but without the physical field programming treatment, and its PDI value is not less than 35%. (c) Having a functional transition fingerprint: Compared with the control system without the physical field programming treatment, the apparent solubility of the functional active ingredient in the alcohol-soluble medium is increased by not less than 50%, and its cumulative dissolution rate in the simulated intestinal fluid over 2 hours is not less than 90%, wherein the pH of the simulated intestinal fluid is 6.

8.

2. The dynamic supramolecular assembly alcohol-soluble functional system according to claim 1, characterized in that, After being processed by physical field programming, the system's Zeta potential undergoes a regular dynamic evolution. During the subsequent static incubation at 15-25℃, the change in its Zeta potential value is no less than 30% of the initial absolute value. If the initial value is negative, the absolute value is taken.

3. The dynamic supramolecular assembly alcohol-soluble functional system according to claim 1, characterized in that, The functional active ingredient is cordycepin, and the plant polyphenols include protocatechuic acid and / or ellagic acid derived from prickly pear pomace.

4. The dynamic supramolecular assembly alcohol-soluble functional system according to claim 3, characterized in that, According to UV-Vis spectroscopy, the characteristic absorption peak of cordycepin in the system shifts by at least 5 nm compared to the cordycepin standard.

5. The dynamic supramolecular assembly alcohol-soluble functional system according to claim 1, characterized in that, The dynamic rheological frequency spectrum of the system, measured by a rotational rheometer at 25°C, showed that its loss modulus (G'') was always greater than its storage modulus (G'), and its zero-shear viscosity was at least an order of magnitude higher than that of the control system with the same composition but without physical field programming.

6. The dynamic supramolecular assembly alcohol-soluble functional system according to any one of claims 1 to 5, characterized in that, The multi-level ordered assembly structure exhibits at least one of the following characteristics in its microstructure: (i) It has a "dust-like" surface topology; (ii) Its interior contains a "sponge-like" three-dimensional network structure formed by the self-assembly of nanoparticles.

7. A method for preparing a dynamic supramolecular assembled alcohol-soluble functional system according to any one of claims 1 to 6, characterized in that, Includes the following steps: (a) Provide raw materials: Provide natural raw material alcohol extracts containing metal ions and plant polyphenols, as well as raw materials containing functional active ingredients; (b) Forming a liquid: The raw materials from step (a) are dispersed or dissolved in an alcohol solution with an alcohol content of 35% vol to 65% vol to form a composite liquid; (c) Induced dynamic coordination assembly: The composite liquid is subjected to physical field programming treatment using a differential pressure suspension vibration intelligent control reactor. The reactor is configured to establish and maintain a net driving pressure difference (ΔP) by synergistically controlling the feed pressure (P1) and back pressure (P2); the feed pressure P1 is controlled within the range of 50 MPa to 200 MPa, and the treatment is performed 1 to 3 times. (d) Stabilization: The liquid treated in step (c) is sealed and allowed to stand at 15-25℃ for no less than 15 days.

8. The method according to claim 7, characterized in that, In step (c), the net driving pressure difference ΔP is controlled within the range of 8-25 MPa; and / or, the natural raw material alcohol extract in step (a) is prickly pear pomace alcohol extract, and the raw material containing functional active ingredients is Cordyceps sinensis.

9. An alcohol-soluble health product, characterized in that, The system comprises a dynamic supramolecular assembly alcohol-soluble functional system according to any one of claims 1 to 6 or a dynamic supramolecular assembly alcohol-soluble functional system prepared by the method according to claim 7 or 8.

10. The alcohol-soluble health product according to claim 9, characterized in that, The product is a health wine with an alcohol content of 35% vol to 65% vol.

11. Use of the dynamic supramolecular assembly alcohol-soluble functional system according to any one of claims 1 to 6 or the alcohol-soluble health product according to claim 9 or 10 in the preparation of formulations for anti-fatigue and / or immune enhancement.

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