A medicinal and edible herbal compound based on Shanxi aged vinegar that helps regulate intestinal flora, its preparation method and application.

Abstract

This invention belongs to the fields of biochemistry and medicinal chemistry. It discloses a medicinal and edible herbal compound based on Shanxi aged vinegar that helps regulate intestinal flora, its preparation method, and its application. The active ingredients are prepared from the following raw materials in parts by weight: 20-40 parts Shanxi aged vinegar, 10-15 parts Astragalus membranaceus, 6-10 parts Hawthorn berries, and 5-10 parts Poria cocos. This invention uses Shanxi aged vinegar as its core, combined with the herbal compound of Astragalus membranaceus, Poria cocos, and Hawthorn berries. For the first time, this invention scientifically combines Shanxi aged vinegar, a traditional fermented food, with classic spleen-strengthening and blood-activating herbs (Astragalus membranaceus, Hawthorn berries, and Poria cocos), embodying the wisdom of traditional Chinese medicine regarding "medicine and food sharing the same origin" and "strengthening the foundation and clearing the source." This produces a synergistic effect, breaking through the traditional production model and product form of Shanxi aged vinegar.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine and food technology, and in particular to a medicinal and edible herbal compound based on Shanxi aged vinegar that helps regulate intestinal flora, its preparation method and application. Background Technology

[0002] Shanxi aged vinegar, one of China's four famous vinegars, holds a very important position in the Chinese vinegar industry due to its unique brewing process and its superior qualities of mellowness, acidity, aroma, and smoothness. It not only possesses a unique flavor and rich active ingredients but also offers various important health benefits, such as anti-oxidation, regulating blood pressure, blood sugar, and blood lipids, and liver protection. Astragalus is a traditional tonic herb with the effects of tonifying the spleen and lungs, strengthening the exterior and stopping sweating, promoting diuresis and reducing swelling, and promoting tissue regeneration. Its core active ingredients, astragalus polysaccharides and astragaloside A, can enhance immunity, combat fatigue, protect the cardiovascular system, and regulate blood sugar. Hawthorn is a fruit used for both food and medicine, promoting digestion and blood circulation. Its core effects are strengthening the stomach and aiding digestion (especially meat-based foods) and assisting in lowering blood lipids. Poria is a fungus used for promoting diuresis, strengthening the spleen, and calming the mind. Its main effects are diuresis, reducing swelling, strengthening the spleen, and calming the nerves. However, current research on Shanxi aged vinegar as a functional food is relatively limited; it is primarily used as a condiment in daily life.

[0003] This invention aims to combine Astragalus membranaceus, hawthorn, and Poria cocos with Shanxi aged vinegar. All three are traditional Chinese medicinal materials that are both food and medicine. It is hoped that a liquid preparation that can help improve the intestinal flora can be developed and effectively applied in the field of functional foods.

[0004] Traditional Chinese medicine (TCM) compound formulas have the advantages of multiple components, multiple targets, and synergistic effects. Organic acids and polyphenols in Shanxi aged vinegar can acidify the intestinal environment. Traditional TCM formulations mostly rely on clinical experience and lack precise target screening criteria, making it difficult to guarantee the scientific validity and effectiveness of the formulations. This invention, based on network pharmacology, constructs a "component-target-pathway" association network, enabling systematic screening of synergistic combinations of medicinal materials, providing theoretical support for the precise formulation of TCM compound formulas.

[0005] Within the existing technological system, several core shortcomings remain in this field: First, Shanxi aged vinegar, one of China's four famous vinegars, possesses abundant active ingredients such as organic acids and polyphenols, and clearly defined health benefits including antioxidant, anti-inflammatory, and metabolic regulation functions. However, it has long been used only as a traditional condiment, and research on its application in functional foods has been insufficient, leading to an underestimation of its functional value. Second, traditional Chinese medicine formulas largely rely on clinical experience for formulation, lacking precise target screening criteria and systematic mechanism research. This makes it difficult to establish a clear "component-target-pathway" relationship, hindering the verification of the formula's scientific validity and effectiveness. Finally, there is limited research on the synergistic development of Shanxi aged vinegar with medicinal and edible resources such as astragalus, hawthorn, and poria. The functional components of each ingredient cannot exert synergistic effects, making it difficult to develop innovative functional foods that possess both unique flavor and clear health benefits.

[0006] To address these issues, this invention proposes the following solutions: First, this invention upgrades Shanxi aged vinegar from a traditional condiment into a core ingredient for functional foods, combining it with astragalus, hawthorn, and poria to develop a liquid formulation, successfully applying it to the functional food field and significantly expanding the product's application scenarios and market value. Second, this invention constructs a "component-target-pathway" association network based on network pharmacology technology, systematically screening for synergistic combinations of medicinal materials, providing solid theoretical support for the precise formulation of traditional Chinese medicine compound prescriptions, overcoming the shortcomings of traditional experience-based formulations, and improving the scientific validity and effectiveness of the formulas. Third, this invention innovatively combines astragalus, hawthorn, and poria with Shanxi aged vinegar, allowing the functional components of each ingredient to work synergistically. Shanxi aged vinegar can acidify the intestinal environment, astragalus can enhance immunity, hawthorn can aid digestion and lower lipids, and poria can strengthen the spleen and calm the mind, ultimately developing a liquid formulation that helps improve the intestinal flora, filling a market gap in this type of functional food and meeting consumers' dual needs for health and flavor. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings of the prior art and provide a medicinal and edible herbal compound based on Shanxi aged vinegar that helps regulate intestinal flora, its preparation method, and its application.

[0008] The technical solution adopted by this invention to solve its technical problem is: A medicinal and edible herbal compound based on Shanxi aged vinegar, which helps regulate intestinal flora, is prepared from the following raw materials in parts by weight: 20-40 parts Shanxi aged vinegar, 10-15 parts Astragalus membranaceus, 6-10 parts hawthorn, and 5-10 parts Poria cocos.

[0009] Furthermore, the medicinal and edible herbal compound is made from the following raw materials in parts by weight: 30 parts Shanxi aged vinegar, 12 parts astragalus, 7 parts hawthorn, and 8 parts poria cocos.

[0010] Furthermore, the main components of the Shanxi aged vinegar are: total acid content of 7.20±0.56 g / 100mL, non-volatile acid content of 3.45±0.64 g / 100mL, total flavonoid content of 128.22±9.46 g / 100mL, and total polyphenol content of 136.70±10.45 g / 100mL.

[0011] The preparation method of the medicinal and edible homology compound as described above includes the following steps: Astragalus, hawthorn and poria were soaked in Shanxi aged vinegar and then extracted with water to obtain an extract, which yielded a compound of medicinal and edible herbs.

[0012] Furthermore, the specific steps are as follows: (1) Weigh out Astragalus membranaceus, hawthorn and Poria cocos by weight, mix them and add Shanxi aged vinegar at a solid-liquid ratio of 1:10-15 as soaking solution. Seal and soak at 15℃-35℃ for 2-4 days, stirring once every 6-8 hours for 5-10 minutes each time. Filter to obtain vinegar-soaked material. (2) Add purified water to the above vinegar-soaked material at a solid-liquid ratio of 1:8, soak for 30 minutes, decoct twice for 1 hour each time, combine the two decoctions, filter to obtain filtrate I, and then concentrate under reduced pressure to obtain concentrate II. (3) The concentrated solution II was filtered through a microporous membrane, the filtrate was collected, purified water was added to the filtrate to make up the volume, the mixture was stirred evenly, and then filtered to obtain the Chinese herbal extract. (4) The extract of traditional Chinese medicine is compounded with excipients, flavored, mixed and filtered, pasteurized and packaged to obtain a liquid preparation of traditional Chinese medicine complex.

[0013] Furthermore, the conditions for vacuum concentration in step (2) are: the vacuum degree is maintained at -0.06 to -1.0 MPa, and the heating temperature is maintained at 55-85℃; Alternatively, the pasteurization and packaging in step (4) specifically involves placing the solution in a pasteurization device and sterilizing it at 65-70°C for 30 minutes. The cleanliness of the filling environment should reach Class 10,000 to ensure that it meets the national safety requirements. Alternatively, in step (4), the excipients are honey and xanthan gum, with the amounts of honey and xanthan gum being 5%-10% and 0.05%-0.10% of the total weight of the herbal extract, respectively. Add some honey under gentle stirring until completely dissolved. Then, premix xanthan gum with the remaining honey and slowly add it to the system, stirring continuously for 30-40 minutes until the system is uniform and stable. The mixed liquid is then filtered through a 0.45μm microporous membrane.

[0014] Furthermore, in step (2), the concentration needs to be carried out under reduced pressure at 60°C, the relative density of concentrate II is 1.10-1.15, and it is concentrated to 0.4-0.5 times the original volume of filtrate I; Alternatively, the conditions for decocting in step (2) are: each decoction is 1 hour, the mixed medicinal materials need to be soaked for 30 minutes, the entire process is heated with boiling water at normal pressure, and the temperature is controlled at 95℃; the two decoctions are combined and filtered to avoid loss of active ingredients; Alternatively, the conditions for membrane filtration in step (3) are: 0.22 μm; and the mass ratio of purified water added to concentrate II in step (3) is 1:1 to 2:1.

[0015] Furthermore, concentration needs to be carried out under reduced pressure at 60°C, and the final concentration has a relative density of 1.10-1.15.

[0016] The use of the above-mentioned medicinal and edible herbal compound in the preparation of products for regulating intestinal flora.

[0017] Furthermore, the recommended dosage of the medicinal and edible herbal compound is 5-10 mL per day, taken twice daily, in the morning and evening.

[0018] The advantages and positive effects of this invention are as follows: 1. This invention uses Shanxi aged vinegar as its core ingredient, combined with a compound of traditional Chinese medicine ingredients including astragalus, poria cocos, and hawthorn. For the first time, this traditional fermented food is scientifically combined with classic spleen-strengthening and blood-activating Chinese herbs (astragalus, hawthorn, and poria cocos), embodying the wisdom of traditional Chinese medicine regarding "medicine and food sharing the same origin" and "strengthening the foundation and clearing the source." This produces a synergistic effect, breaking through the traditional production model and product form of Shanxi aged vinegar.

[0019] 2. This invention is based on Shanxi aged vinegar, combined with astragalus, hawthorn and poria. The optimal ratio was obtained through screening and verification by network pharmacology, which breaks through the limitations of traditional Chinese medicine experience in combination. The three ingredients, in accordance with the prescription scope and preparation process disclosed in this patent, achieve synergistic effects of multiple components and multiple targets, and have significant synergistic effects.

[0020] 3. This invention specifies a concentration range for the process of combining traditional Chinese medicine complexes with Shanxi aged vinegar, strictly controlling the relative density and volume concentration ratio to balance the preservation of active ingredients and the stability of the formulation. Concentrating the traditional Chinese medicine extract to the relative density range of this invention can fully enrich water-soluble active ingredients; the reduced pressure and low temperature environment can reduce the loss of volatile components, while also achieving a suitable consistency for better mixing with Shanxi aged vinegar. Similarly, the parameters of Shanxi aged vinegar in this invention not only increase the concentration of organic acids and inhibit the action of harmful bacteria, but also remove excess acetic acid from the vinegar, preventing excessive acidity from harming the human body.

[0021] 4. The raw materials used in this invention, such as Poria cocos, hawthorn and Astragalus membranaceus, are all medicinal and edible materials. Shanxi aged vinegar is a traditional fermented condiment with no chemically synthesized additives. It is healthy, safe and suitable for a wide range of people.

[0022] 5. This invention is carried out according to the following steps: weighing raw materials, soaking in Shanxi aged vinegar, extracting traditional Chinese medicine, mixing and blending, and sterilizing and bottling. The raw material of the traditional Chinese medicine compound is based on Shanxi aged vinegar, with a reasonable combination of astragalus, hawthorn, and poria cocos, which work together to exert a health-preserving effect that helps regulate the intestinal flora. It can be developed into a traditional Chinese medicine compound preparation with clear therapeutic effects, or it can be used as a functional health food, with broad market prospects and flexible product forms.

[0023] 6. This invention utilizes an innovative "vinegar soaking followed by water extraction" process, taking advantage of the acidic environment and organic components of Shanxi aged vinegar to pretreat astragalus, hawthorn, and poria cocos, significantly increasing the content of total polyphenols and individual polyphenols and other functional components in the complex. This process significantly enhances efficacy, resulting in a final product that performs exceptionally well in regulating intestinal flora, more effectively promoting the proliferation of core probiotics, and demonstrating efficacy clearly superior to traditional water extraction processes.

[0024] 7. The herbal compound of this invention is made from Shanxi aged vinegar, astragalus, hawthorn, and poria cocos through steps such as weighing the raw materials, soaking in Shanxi aged vinegar, vacuum concentration, extraction of the herbal ingredients, mixing and blending, and sterilization and bottling. The herbal components, combined with aged vinegar and natural excipients, work synergistically to regulate the intestinal flora while supplementing the body with essential nutrients such as polysaccharides, flavonoids, and organic acids, thus achieving the dual benefits of intestinal health regulation and nutritional supplementation.

[0025] 8. This invention is based on the concept of "medicine and food from the same source" and network pharmacology to screen traditional Chinese medicines such as Astragalus membranaceus, hawthorn and Poria cocos. By constructing a network of "component-target-disease regulation pathways", it can accurately screen the optimal ratio of medicinal materials and aged vinegar, breaking through the blindness of traditional Chinese medicine experience compatibility and providing a scientific basis.

[0026] 9. The present invention addresses the deficiencies of the existing technology. Its main objective is to provide a traditional Chinese medicine complex based on Shanxi aged vinegar, combined with Astragalus membranaceus, Poria cocos and hawthorn, and its preparation method and application.

[0027] 10. This invention designs a traditional Chinese medicine complex with Shanxi aged vinegar as the core, combined with Astragalus membranaceus, Poria cocos, and hawthorn, as well as its preparation method and application. Based on network pharmacology, the invention screens this traditional Chinese medicine complex and its application in regulating intestinal flora imbalance-related diseases. On one hand, this invention employs a "vinegar-soaking followed by water extraction" process, that is, first soaking the medicinal mixture in Shanxi aged vinegar, then adding water for decoction extraction. This significantly increases the content of total polyphenols and individual polyphenols (such as gallic acid and quercetin) in the final product. On the other hand, network pharmacology and experiments confirm that the product prepared by this formulation has excellent and unique intestinal flora regulation functions. This invention elevates vinegar from an excipient to a key extraction solvent, and uses network pharmacology as a basis, providing an innovative solution for developing health foods or drugs that regulate intestinal microecology. Attached Figure Description

[0028] Figure 1 This is a network diagram of the active ingredients and targets of the traditional Chinese medicine complex in this invention; Figure 2 This is a Veen diagram of the target-disease target of the traditional Chinese medicine complex in this invention; Figure 3 This is a schematic diagram of the PPI network of the traditional Chinese medicine complex-key disease target in this invention; Figure 4 This is a horizontal abundance histogram in this invention; Figure 5 This is a bar chart showing the abundance of species at different levels in this invention. Detailed Implementation

[0029] The present invention will be further described below with reference to the embodiments. The following embodiments are descriptive and not limiting, and should not be used to limit the scope of protection of the present invention.

[0030] The various experimental operations involved in the specific embodiments are all conventional techniques in the field. For parts not specifically annotated in this document, those skilled in the art can refer to various commonly used reference books, scientific and technological documents or related instructions and manuals prior to the filing date of this invention to carry out the operations.

[0031] A medicinal and edible herbal compound based on Shanxi aged vinegar, which helps regulate intestinal flora, is prepared from the following raw materials in parts by weight: 20-40 parts Shanxi aged vinegar, 10-15 parts Astragalus membranaceus, 6-10 parts hawthorn, and 5-10 parts Poria cocos.

[0032] Furthermore, the medicinal and edible herbal compound is made from the following raw materials in parts by weight: 30 parts Shanxi aged vinegar, 12 parts astragalus, 7 parts hawthorn, and 8 parts poria cocos.

[0033] Furthermore, the main components of the Shanxi aged vinegar are: total acid content of 7.20±0.56 g / 100mL, non-volatile acid content of 3.45±0.64 g / 100mL, total flavonoid content of 128.22±9.46 g / 100mL, and total polyphenol content of 136.70±10.45 g / 100mL.

[0034] The preparation method of the medicinal and edible homology compound as described above includes the following steps: Astragalus, hawthorn and poria were soaked in Shanxi aged vinegar and then extracted with water to obtain an extract, which yielded a compound of medicinal and edible herbs.

[0035] Furthermore, the specific steps are as follows: (1) Weigh out Astragalus membranaceus, hawthorn and Poria cocos by weight, mix them and add Shanxi aged vinegar at a solid-liquid ratio of 1:10-15 as soaking solution. Seal and soak at 15℃-35℃ for 2-4 days, stirring once every 6-8 hours for 5-10 minutes each time. Filter to obtain vinegar-soaked material. (2) Add purified water to the above vinegar-soaked material at a solid-liquid ratio of 1:8, soak for 30 minutes, decoct twice for 1 hour each time, combine the two decoctions, filter to obtain filtrate I, and then concentrate under reduced pressure to obtain concentrate II. (3) The concentrated solution II was filtered through a microporous membrane, the filtrate was collected, purified water was added to the filtrate to make up the volume, the mixture was stirred evenly, and then filtered to obtain the Chinese herbal extract. (4) The extract of traditional Chinese medicine is compounded with excipients, flavored, mixed and filtered, pasteurized and packaged to obtain a liquid preparation of traditional Chinese medicine complex.

[0036] Furthermore, the conditions for vacuum concentration in step (2) are: the vacuum degree is maintained at -0.06 to -1.0 MPa, and the heating temperature is maintained at 55-85℃; Alternatively, the pasteurization and packaging in step (4) specifically involves placing the solution in a pasteurization device and sterilizing it at 65-70°C for 30 minutes. The cleanliness of the filling environment should reach Class 10,000 to ensure that it meets the national safety requirements. Alternatively, in step (4), the excipients are honey and xanthan gum, with the amounts of honey and xanthan gum being 5%-10% and 0.05%-0.10% of the total weight of the herbal extract, respectively. Add some honey under gentle stirring until completely dissolved. Then, premix xanthan gum with the remaining honey and slowly add it to the system, stirring continuously for 30-40 minutes until the system is uniform and stable. The mixed liquid is then filtered through a 0.45μm microporous membrane.

[0037] Furthermore, in step (2), the concentration needs to be carried out under reduced pressure at 60°C, the relative density of concentrate II is 1.10-1.15, and it is concentrated to 0.4-0.5 times the original volume of filtrate I; Alternatively, the conditions for decocting in step (2) are: each decoction is 1 hour, the mixed medicinal materials need to be soaked for 30 minutes, the entire process is heated with boiling water at normal pressure, and the temperature is controlled at 95℃; the two decoctions are combined and filtered to avoid loss of active ingredients; Alternatively, the conditions for membrane filtration in step (3) are: 0.22 μm; and the mass ratio of purified water added to concentrate II in step (3) is 1:1 to 2:1.

[0038] Furthermore, concentration needs to be carried out under reduced pressure at 60°C, and the final concentration has a relative density of 1.10-1.15.

[0039] The use of the above-mentioned medicinal and edible herbal compound in the preparation of products for regulating intestinal flora.

[0040] Furthermore, the recommended dosage of the medicinal and edible herbal compound is 5-10 mL per day, taken twice daily, in the morning and evening.

[0041] This invention uses network pharmacology technology to verify the scientific validity and accuracy of the medicinal and edible herbal compound based on Shanxi aged vinegar, which helps regulate intestinal flora. The specific steps are as follows: (1) Screening of active ingredients and potential targets: The Traditional Chinese Medicine Systems Pharmacology Database (TCMSP) was used to collect the active ingredients of Astragalus membranaceus, Crataegus pinnatifida and Poria cocos, including astragaloside A, Poria cocos polysaccharide, and total flavonoids of Crataegus pinnatifida. The characteristic components of Shanxi aged vinegar, including acetic acid and lactic acid, were also explored by combining literature and the Food Science Database (FooDB).

[0042] Constructing an "active ingredient-target" interaction network (see...) Figure 1 As shown in the figure, the multiple active ingredients in the composition of Astragalus membranaceus, hawthorn, Poria cocos and Shanxi aged vinegar in this invention can work together on multiple overlapping targets to form a dense "multi-component-multi-target" network.

[0043] (2) Target prediction: The SwissTargetPrediction database is used to predict the potential targets of all the above active ingredients, and finally the potential target set of the composition is obtained.

[0044] (3) Disease target mining: Search for disease targets related to metabolic syndrome from the DisGeNET and GeneCards databases and construct a disease target set.

[0045] (4) Core target screening and network construction: Take the intersection of the component target set and the disease target set (see Figure 2 The results showed that there were 93 significant overlapping target points between the two.

[0046] A "component-target-disease" association network was constructed using Cytoscape software; network topology parameters (degree, betweenness centrality) were calculated, and core targets, including PPARG, AMPK, etc., were screened out (see...). Figure 3 Based on the matching degree between the core target and the components of each medicinal material, the optimal weight range of Astragalus membranaceus, Poria cocos, and stir-fried hawthorn, as well as the volume range of Shanxi aged vinegar, were determined.

[0047] Through the Figure 1 , Figure 2 and Figure 3 Based on the systematic analysis, the technical solution of this invention demonstrates the following outstanding advantages in both elucidating the scientific nature of the mechanism of action and verifying the synergistic effect: Figure 1 This invention visually presents the component-target interaction network of the herbal complex, including more than 15 classes of active ingredients such as astragaloside A, total flavonoids from hawthorn, polysaccharides from Poria cocos, and acetic acid from Shanxi aged vinegar, as well as 76 key targets such as AKT1, MAPK8, INSR, VEGFA, and PPARG. On average, each target in the network is connected to 3-5 active ingredients; for example, AKT1 is simultaneously regulated by components from astragalus, hawthorn, and aged vinegar. This dense interaction is not random but corresponds to functional modules such as intestinal barrier repair (VEGFA, AKT1), regulation of glucose and lipid metabolism (INSR, PPARG), and regulation of inflammatory responses (MAPK8, PTGS2). Data shows that over 60% of the predicted targets are directly associated with pathways related to intestinal health or metabolic syndrome, clearly demonstrating at the system level that this invention is not a simple superposition of the efficacy of medicinal materials, but rather provides direct network topology evidence for the functional synergy of the compound through the synergistic regulation of overlapping target groups by component groups.

[0048] Figure 2 This indicates that the herbal compound used in this invention identified 413 potential targets and 4698 targets related to metabolic syndrome, with 93 common targets. This result directly proves that the herbal compound of this invention has a significant overlap in biological targets with metabolic syndrome. This compound can directly act on the pathophysiological processes of metabolic syndrome by regulating these 93 core common targets, providing a clear biological basis for subsequent precise formulation.

[0049] Figure 3Further protein-protein interaction (PPI) network analysis of the core targets identified the top 20 key targets by degree, including AKT1, TP53, MAPK8, INSR, VEGFA, IL-6, and STAT3. These targets act as hub targets, with each directly interacting with more than 15 other targets within the network on average. For example, AKT1 and TP53, as the network core, directly connect multiple functional modules such as cell proliferation, metabolism, and inflammatory responses. This highly interconnected network structure is very stable and exhibits strong integrative function. This means that the active ingredient combination of this invention only needs to pass through a few key hubs (such as AKT1) to generate a wide range of cascade effects, thereby efficiently regulating multiple interrelated biological processes, and also explaining the molecular basis for potentially significant overall efficacy.

[0050] In summary, this study not only provides an innovative formula for developing a novel functional food that improves gut microbiota, but also endows it with solid scientific connotation and mechanism explanation through modern network pharmacology methods, greatly enhancing the innovation, predictability and industrial application value of this invention.

[0051] As described above, a traditional Chinese medicine compound with Shanxi aged vinegar as its core and combined with astragalus, poria cocos, and hawthorn is used in the preparation of functional foods that help regulate intestinal flora.

[0052] Specifically, the relevant preparation and testing methods are as follows: A medicinal and edible herbal compound based on Shanxi aged vinegar, combined with astragalus, poria cocos, and hawthorn, which helps regulate intestinal flora. The herbal compound is made from the following raw materials in parts by weight: 300mL Shanxi aged vinegar, 120g astragalus, 70g hawthorn, 80g poria cocos.

[0053] The preparation method of the above-mentioned traditional Chinese medicine complex includes the following steps: (1) Weigh out Astragalus membranaceus, hawthorn and Poria cocos by weight, mix them and add 300mL of Shanxi aged vinegar as soaking solution. Soak in Shanxi aged vinegar at 15℃-35℃ for 3 days, stirring once every 8 hours for 10 minutes each time.

[0054] (2) Add 2000 mL of purified water to the above vinegar-soaked material at a solid-liquid ratio of about 1:8, soak for 30 min, decoct twice for 1 h each time, combine the two decoctions, filter to obtain filtrate I, and then concentrate under reduced pressure to obtain concentrate II.

[0055] (3) Filter concentrated solution II through a 0.22 μm microporous membrane, collect the filtrate, add 1000 mL of purified water to the filtrate and stir well. Filter through the same membrane to obtain the herbal extract.

[0056] (4) Honey and xanthan gum were added to the traditional Chinese medicine extract as excipients, at amounts of 5%-10% and 0.05%-0.10% of the total weight of the extract, respectively. When adjusting the flavor, a portion of honey was added under gentle stirring until completely dissolved; then, xanthan gum was premixed with the remaining honey and slowly added to the system, stirring continuously for 30-40 minutes until the system was homogeneous and stable. The mixed solution was filtered through a 0.45μm microporous membrane. It was then pasteurized and packaged to obtain a liquid preparation of the traditional Chinese medicine complex.

[0057] The conditions for vacuum concentration in step (2) are: vacuum degree maintained at -0.07MPa and heating temperature maintained at 75℃.

[0058] In step (2), the relative density of concentrate II is 1.13, and it is concentrated to 0.5 times the original volume of filtrate I.

[0059] The decoction extraction conditions for Astragalus membranaceus, hawthorn, and Poria cocos in step (1) are as follows: Weigh Astragalus membranaceus, hawthorn, and Poria cocos, use water extraction, mix them, add 2000 mL of purified water, decoct twice, each time for 1 hour, and soak the mixed herbs for 30 minutes. Use normal pressure boiling water for heating throughout the process, and control the temperature at 95℃. Combine the two decoctions and filter to avoid loss of active ingredients.

[0060] In step (3), the mixed solution is sterilized and packaged using pasteurization. The solution is placed in pasteurization equipment and sterilized at 70°C for 30 minutes. The cleanliness of the filling environment should reach Class 10,000 to ensure that it meets the national safety requirements.

[0061] The final product yields 1000 mL of oral liquid, which can be bottled in 10 mL vials. For regulating intestinal flora, the recommended oral dose is 10 mL twice daily, morning and evening.

[0062] Example 1: The method for preparing traditional Chinese medicine complexes using the preparation method described above includes the following steps: Ingredients and dosage: 300mL Shanxi aged vinegar, 120g astragalus, 70g hawthorn, 80g poria.

[0063] Operating steps: Vinegar soaking: Soak in a sealed container at 15℃-35℃ for 3 days, stirring for 10 minutes every 8 hours; Water extraction: Add 2000mL of purified water, soak for 30 minutes, then decoct twice at 95℃ (1 hour each time); Concentration: Concentrate under reduced pressure (-0.07MPa, 75℃) to 0.5 times the volume of filtrate I, with a relative density of 1.13; Volume adjustment: Add 1000mL of purified water to make up the volume, and pasteurize at 70℃ for 30 minutes.

[0064] The recommended oral dose is 10 mL, twice daily.

[0065] Example 2: Example 2 changed the proportions of each raw material, while keeping other conditions the same as in Example 1. That is: Ingredients and dosage: 200mL Shanxi aged vinegar, 90g Astragalus membranaceus, 50g hawthorn, 70g Poria cocos.

[0066] Operating steps: Vinegar soaking: Soak in a sealed container at 15℃-35℃ for 3 days, stirring for 10 minutes every 8 hours; Water extraction: Add 2000mL of purified water, soak for 30 minutes, then decoct twice at 95℃ (1 hour each time); Concentration: Concentrate under reduced pressure (-0.07MPa, 75℃) to 0.5 times the volume of filtrate I, with a relative density of 1.13; Volume adjustment: Add 1000mL of purified water to make up the volume, and pasteurize at 70℃ for 30 minutes.

[0067] The recommended oral dose is 10 mL, twice daily.

[0068] Example 3: Example 3 changed the reduced pressure concentration conditions, while keeping other conditions the same as in Example 1. That is: Ingredients and dosage: 300mL Shanxi aged vinegar, 120g astragalus, 70g hawthorn, 80g poria.

[0069] Operating steps: Vinegar soaking: Soak in a sealed container at 15℃-35℃ for 3 days, stirring for 10 minutes every 8 hours; Water extraction: Add 2000mL of purified water, soak for 30 minutes, then decoct twice at 95℃ (1 hour each time); Concentration: Concentrate under reduced pressure (-0.08MPa, 85℃) to 0.5 times the volume of filtrate I, with a relative density of 1.13; Volume adjustment: Add 1000mL of purified water to make up the volume, and pasteurize at 70℃ for 30 minutes.

[0070] The recommended oral dose is 10 mL, twice daily.

[0071] Example 4: Example 4 reduces one ingredient, Astragalus membranaceus, while keeping all other conditions the same as in Example 1. That is: Ingredients and dosage: 300mL Shanxi aged vinegar, 70g hawthorn, 80g Poria cocos.

[0072] Operating steps: Vinegar soaking: Soak in a sealed container at 15℃-35℃ for 3 days, stirring for 10 minutes every 8 hours; Water extraction: Add 2000mL of purified water, soak for 30 minutes, then decoct twice at 95℃ (1 hour each time); Concentration: Concentrate under reduced pressure (-0.07MPa, 75℃) to 0.5 times the volume of filtrate I, with a relative density of 1.13; Volume adjustment: Add 1000mL of purified water to make up the volume, and pasteurize at 70℃ for 30 minutes.

[0073] The recommended oral dose is 10 mL, twice daily.

[0074] Example 5: Example 5 reduces one ingredient, Poria cocos, while maintaining the same conditions as Example 1. That is: Ingredients and dosage: 300mL Shanxi aged vinegar, 120g astragalus, 70g hawthorn.

[0075] Operating steps: Vinegar soaking: Soak in a sealed container at 15℃-35℃ for 3 days, stirring for 10 minutes every 8 hours; Water extraction: Add 2000mL of purified water, soak for 30 minutes, then decoct twice at 95℃ (1 hour each time); Concentration: Concentrate under reduced pressure (-0.07MPa, 75℃) to 0.5 times the volume of filtrate I, with a relative density of 1.13; Volume adjustment: Add 1000mL of purified water to make up the volume, and pasteurize at 70℃ for 30 minutes.

[0076] The recommended oral dose is 10 mL, twice daily.

[0077] Example 6: Example 6 was performed without concentration and with a different relative density, while all other conditions remained the same as in Example 1. That is: Ingredients and dosage: 300mL Shanxi aged vinegar, 120g astragalus, 70g hawthorn, 80g poria.

[0078] Operating steps: Vinegar soaking: Soak in a sealed container at 15℃-35℃ for 3 days, stirring for 10 minutes every 8 hours; Water extraction: Add 2000mL of purified water, soak for 30 minutes, then decoct twice at 95℃ (1 hour each time); Relative density 1.10; Volume adjustment: Add 1000mL of purified water to make up the volume, and pasteurize at 70℃ for 30 minutes.

[0079] The recommended oral dose is 10 mL, twice daily.

[0080] Example 7: Example 7: The dosage was changed, while other conditions remained the same as in Example 1. That is: Ingredients and dosage: 300mL Shanxi aged vinegar, 120g astragalus, 70g hawthorn, 80g poria.

[0081] Operating steps: Vinegar soaking: Soak in a sealed container at 15℃-35℃ for 3 days, stirring for 10 minutes every 8 hours; Water extraction: Add 2000mL of purified water, soak for 30 minutes, then decoct twice at 95℃ (1 hour each time); Concentration: Concentrate under reduced pressure (-0.07MPa, 75℃) to 0.5 times the volume of filtrate I, with a relative density of 1.13; Volume adjustment: Add 1000mL of purified water to make up the volume, and pasteurize at 70℃ for 30 minutes.

[0082] The recommended oral dose is 20 mL, once daily.

[0083] Test Example 1: This invention provides a traditional Chinese medicine complex with Shanxi aged vinegar as the core, combined with Astragalus membranaceus, Poria cocos, and hawthorn, as well as its preparation method and application. To demonstrate its functional effects, in vivo evaluation of the intestinal flora improvement of samples provided in all the above embodiments was conducted, and the results are as follows: Eighty normal male SPF-grade mice, aged 8 weeks and weighing 22-30 g, were selected for the experiment and fed standard mouse feed. The mice were randomly divided into two groups: a normal group and experimental groups 1-7, with 10 mice in each group. Experimental groups 1-7 were administered the samples prepared in Examples 1-7, calculated based on a daily oral intake of 21 mL for a 70 kg adult (equivalent to 10), 21 × 10 / 70 = 3 mL / kg / day. Subsequent doses were administered at 3 mL / kg / day, except for experimental group 7 which received the medication once daily; the other groups received the medication twice daily (morning and evening). The normal group received an equal volume of 0.9% saline via gavage for 4 weeks. At the end of the experiment, fresh feces were collected from each group, and the contents of acetic acid and butyric acid were determined by gas chromatography. Among the many short-chain fatty acids produced by intestinal flora metabolism, butyric acid is recognized as the most crucial biomarker for assessing the beneficial functions of intestinal flora due to its core role in host energy metabolism, intestinal barrier function, and immune regulation. Therefore, increasing the content of short-chain fatty acids is a key target for improving gut microbiota and thus intervening in related diseases.

[0084] Table 1. Changes in butyrate concentration in mice (X±S)

[0085] Note: Compared with the normal group, the experimental group... The experimental group was significantly different from the normal group (P < 0.001). Table 2. Changes in acetic acid concentration in mice (X±S)

[0086] Note: Compared with the normal group, the experimental group... The experimental group was significantly different from the normal group (P < 0.001). Table 3. Changes in propionic acid concentration in mice (X±S)

[0087] Note: Compared with the normal group, the experimental group... The experimental group was significantly different from the normal group (P < 0.001). Table 4. Changes in isobutyric acid concentration in mice (X±S)

[0088] As shown in Table 1, the concentrations of short-chain fatty acids in the normal group mice were significantly higher than those in the other experimental groups before and after 4 weeks of administration. Before administration, there were no significant differences in acetic acid and butyric acid concentrations between the normal group and the experimental groups. After 4 weeks of administration, compared with the normal group, there were no significant differences in acetic acid and butyric acid concentrations in experimental groups 4-6, indicating that the absence of a certain traditional Chinese medicine and changes in relative density greatly affected the efficacy in improving intestinal flora. The concentrations of short-chain fatty acids in experimental groups 1-3 and 7 were significantly increased, with experimental group 1 showing the best effect. Experimental groups 2, 3, and 7 showed less effective results compared to experimental group 1, but still showed significant differences (P<0.05), indicating that changes in prescription dosage, preparation method, and administration method were all ineffective in improving intestinal flora. From the above, it can be concluded that Example 1 had the best effect in improving intestinal flora. As a marker of protein fermentation, isobutyric acid remained stable in all experimental groups without significant increase (P>0.05). Isobutyric acid, used as a control, provides a stark contrast: this invention significantly enhances the selectivity of acetic acid, propionic acid, and butyric acid from carbohydrate fermentation without disrupting isobutyric acid produced by protein fermentation. This invention does not blindly stimulate all microbial communities but precisely improves their function, demonstrating its safety and precision—core characteristics of a high-quality microecological regulator.

[0089] Meanwhile, by comparing Examples 1, 4, and 5 with Experimental Groups 1, 4, and 5, it can be seen that the absence of any one of the Chinese medicinal herbs in this invention will affect its efficacy, indicating that Shanxi aged vinegar and these three Chinese medicinal herbs have a good synergistic effect and can synergistically improve the relevant characteristics of this Chinese medicine complex in improving intestinal flora.

[0090] Meanwhile, by comparing Examples 1, 4, and 5, it can be seen that Astragalus and Poria cocos in the components of the medicinal and edible herbal compound of the present invention have a synergistic effect, which can synergistically improve the relevant properties of the prepared medicinal and edible herbal compound. In particular, Astragalus and Poria cocos in the component of the medicinal and edible herbal compound of the present invention with a mass ratio of 120:80 have a significant synergistic effect, which can significantly synergistically improve the relevant properties of the prepared medicinal and edible herbal compound.

[0091] Test Example 2: Based on the experimental method of Test Example 1, in order to explore the direct effect of traditional Chinese medicine complex on the structure of intestinal flora, while collecting fecal samples for short-chain fatty acid detection, another parallel fecal sample was aseptically collected from each mouse, which was used for subsequent 16S rRNA gene high-throughput sequencing analysis to reveal changes in flora composition.

[0092] like Figure 4As shown, compared with the normal group, experimental groups 1-3 and 7 all significantly regulated the abundance of key gut microbiota, with experimental group 1 showing the best effect. Experimental groups 2, 3, and 7 showed less effective results compared to experimental group 1, indicating that changing the prescription dosage, preparation method, and administration method were all ineffective in improving the gut microbiota. Beneficial bacteria genera Akkermansia and Faecalibacterium The relative abundance of harmful bacteria increased from 3.5% and 3.0% to 8.9% and 7.2%, respectively (an increase of 154% and 140%, respectively, P<0.001); meanwhile, harmful bacteria... Desulfovibrio The relative abundance of [a substance] decreased significantly from 1.5% to 0.6% (a decrease of 60%, P<0.001). The regulatory effect of experimental groups 4-6 was significantly weakened. Akkermansia The percentage was only 4.8%, which was not significantly different from the normal group. This indicates that the absence of Shanxi aged vinegar, the absence of a certain Chinese herbal medicine in the prescription, and changes in relative density can all affect the efficacy of improving gut microbiota.

[0093] Based on the observations in the above-mentioned genus-level analysis Akkermansia , Faecalibacterium The significant increase in beneficial bacteria genera led to a deeper exploration of their functional significance, and further analysis was conducted on representative species within these genera that exhibit clear probiotic functions. For example... Figure 5 As shown, this invention can specifically and significantly promote the proliferation of the following key probiotic strains: Akkermansia muciniphila A core bacterial species responsible for degrading mucin and maintaining the integrity of the intestinal barrier, whose abundance increased from 2.1% to 6.5% (P<0.001). Faecalibacterium prausnitzii One of the most important butyrate-producing bacteria in the human gut, possessing strong anti-inflammatory properties, its abundance increased from 1.8% to 5.0% (P<0.001); Meanwhile, harmful bacteria... Desulfovibrio piger The abundance of hydrogen sulfide was significantly suppressed.

[0094] Notably, experimental groups 4-6 showed a significant reduction in the aforementioned precise regulatory effect at the species level. This result indicates that the present invention's regulation of the gut microbiota is not a broad-spectrum, non-specific change in quantity, but rather a precise targeting and enrichment of beneficial functional bacteria closely related to gut health with clearly defined functions. This reveals its potential mechanism of action from a more refined biological perspective.

[0095] Meanwhile, by comparing Examples 1, 4, and 5, it can be seen that Astragalus and Poria cocos in the components of the medicinal and edible herbal compound of the present invention have a synergistic effect, which can synergistically improve the relevant properties of the prepared medicinal and edible herbal compound. In particular, Astragalus and Poria cocos in the component of the medicinal and edible herbal compound of the present invention with a mass ratio of 120:80 have a significant synergistic effect, which can significantly synergistically improve the relevant properties of the prepared medicinal and edible herbal compound.

[0096] Test Example 3: To investigate the effect of preparation process on the efficacy components of the product, samples were prepared according to the prescription of Example 1 of this invention (300mL of Shanxi aged vinegar, 120g of astragalus, 70g of hawthorn, and 80g of poria cocos) using the following three processes: Group A (process of this invention): prepared according to the "vinegar soaking followed by water extraction" process of Example 1.

[0097] Group B (Control Process 1): Based on Example 1, the medicinal materials were decocted twice with 2000mL of water, concentrated, and then 300mL of Shanxi aged vinegar was added to make up to 1000mL (first water extraction and then vinegar soaking).

[0098] Group C (Control Process 2): Based on Example 1, the medicinal materials were decocted twice with only 2000mL of water, concentrated, and then brought to a final volume of 1000mL (water extraction only).

[0099] The total polyphenol and individual polyphenol contents were determined using the three processes described above.

[0100] Total polyphenol content determination: The Folin-phenol method was used.

[0101] Accurately weigh each extract and prepare a series of standard solutions with gallic acid standard. Accurately measure 0.2 mL of each solution into a 10 mL colorimetric tube, add 0.8 mL of Folin-phenol reagent, mix well and react for 20 min. Then add 1.5 mL of 7.5% sodium carbonate solution and dilute to 10 mL with deionized water. Incubate at room temperature in the dark for 1.5 h, and measure the absorbance at 765 nm. Construct a standard curve using gallic acid as the standard, and calculate the total polyphenol content in the samples. The results are expressed as gallic acid equivalents (mg GAE / g extract). Each sample was measured in triplicate.

[0102] Determination of individual polyphenol content: The content of individual polyphenols (such as gallic acid and quercetin) was determined by high performance liquid chromatography.

[0103] Chromatographic conditions: C18 column (4.6 mm × 250 mm, 5 μm); mobile phase: acetonitrile (A) - 0.1% phosphoric acid aqueous solution (B), gradient elution (0–20 min, 10%–25% A); flow rate: 1.0 mL / min; column temperature: 30℃; detection wavelength: gallic acid 273 nm, quercetin 254 nm. Quantification was performed using external standard method.

[0104] Table 5 Total polyphenols and content of each polyphenol (X±S) for the three processes

[0105] The results are shown in Table 5. The data indicates that the total polyphenol and two characteristic polyphenol contents in Group A ("vinegar soaking followed by water extraction") were significantly higher than those in Groups B and C (P<0.05). This means that this process significantly increases the content of total polyphenols and characteristic phenolic acids (gallic acid and quercetin) in the final product. This proves that the initial soaking of Shanxi aged vinegar increases the total polyphenol content and the content of individual active ingredients. Therefore, this invention, by changing the timing of vinegar intervention, achieves a global enhancement and selective enrichment of polyphenols, especially characteristic active ingredients such as gallic acid and quercetin, an effect that cannot be achieved by traditional "water extraction followed by vinegar" or "water extraction only" processes.

[0106] Meanwhile, by comparing Example 1 (Groups A, B, and C) in Example 3, it can be seen that step (1) of the preparation method of the medicinal and edible herbal compound of the present invention, namely “(1) Weigh Astragalus membranaceus, Crataegus pinnatifida, and Poria cocos according to the weight proportions, mix them, add 300 mL of Shanxi aged vinegar as soaking solution, and soak them in Shanxi aged vinegar at 15℃-35℃ for 3 days, stirring once every 8 hours for 10 minutes each time.” and step (2) of the above vinegar-soaked material, namely “(2) Add 2000 mL of purified water to the above vinegar-soaked material at a solid-liquid ratio of about 1:8, soak for 30 minutes, decoct twice for 1 hour each time, combine the two decoctions, filter to obtain filtrate I, and then concentrate under reduced pressure to obtain concentrate II.” have a synergistic effect and can synergistically improve the relevant properties of the prepared medicinal and edible herbal compound.

[0107] As can be seen from the direct comparison with the closest prior art, the "water extraction followed by vinegar extraction" process, the total polyphenol content of the "vinegar soaking followed by water extraction" process used in this invention is 125.6±8.2 mgGAE / g, and the contents of the characteristic active ingredients gallic acid and quercetin reach 5.82±0.45 mg / g and 3.21±0.30 mg / g, respectively. The extraction efficiency of key active ingredients is significantly improved: the total polyphenol content increases by 27.8%, the gallic acid content increases by 40.9%, and the quercetin content increases by 26.9%. Compared with the more traditional "water extraction only" process, the improvement is further expanded to 31.2% for total polyphenols, 46.2% for gallic acid, and 31.0% for quercetin.

[0108] These data directly demonstrate that this invention achieves synergistic and efficient extraction of polyphenolic components by adjusting the process sequence. This effect is attributed to the use of Shanxi aged vinegar as a pretreatment agent before extraction. Its acidic environment and organic acid components effectively alter the cell structure and polyphenolic forms of the medicinal materials during the soaking stage, thus enabling efficient and selective enrichment of polyphenolic active substances during subsequent water extraction. This result provides strong material basis for the product's excellent function in regulating intestinal flora and also reflects the significant technical advantages of this invention.

[0109] Although embodiments of the invention have been disclosed for illustrative purposes, those skilled in the art will understand that various substitutions, variations, and modifications are possible without departing from the spirit and scope of the invention and the appended claims. Therefore, the scope of the invention is not limited to the contents disclosed in the embodiments.

Claims

1. A medicinal and edible herbal compound based on Shanxi aged vinegar, characterized in that: Its active ingredient is prepared from the following raw materials in parts by weight: 20-40 parts Shanxi aged vinegar, 10-15 parts Astragalus membranaceus, 6-10 parts hawthorn, and 5-10 parts Poria cocos.

2. The medicinal and edible herbal compound according to claim 1, characterized in that: The medicinal and edible herbal compound is made from the following raw materials in parts by weight: 30 parts Shanxi aged vinegar, 12 parts astragalus, 7 parts hawthorn, and 8 parts poria cocos.

3. The medicinal and edible herbal compound according to claim 1 or 2, characterized in that: The main components of the Shanxi aged vinegar are: total acid content of 7.20±0.56 g / 100mL, non-volatile acid content of 3.45±0.64 g / 100mL, total flavonoid content of 128.22±9.46 g / 100mL, and total polyphenol content of 136.70±10.45 g / 100mL.

4. The method for preparing the medicinal and edible homologous traditional Chinese medicine complex according to any one of claims 1 to 3, characterized in that: Includes the following steps: Astragalus, hawthorn and poria were soaked in Shanxi aged vinegar and then extracted with water to obtain an extract, which yielded a compound of medicinal and edible herbs.

5. The preparation method according to claim 4, characterized in that: The specific steps are as follows: (1) Weigh out Astragalus membranaceus, hawthorn and Poria cocos by weight, mix them and add Shanxi aged vinegar at a solid-liquid ratio of 1:10-15 as soaking solution. Seal and soak at 15℃-35℃ for 2-4 days, stirring once every 6-8 hours for 5-10 minutes each time. Filter to obtain vinegar-soaked material. (2) Add purified water to the above vinegar-soaked material at a solid-liquid ratio of 1:8, soak for 30 minutes, decoct twice for 1 hour each time, combine the two decoctions, filter to obtain filtrate I, and then concentrate under reduced pressure to obtain concentrate II. (3) The concentrated solution II was filtered through a microporous membrane, the filtrate was collected, purified water was added to the filtrate to make up the volume, the mixture was stirred evenly, and then filtered to obtain the Chinese herbal extract. (4) The extract of traditional Chinese medicine is compounded with excipients, flavored, mixed and filtered, pasteurized and packaged to obtain a liquid preparation of traditional Chinese medicine complex.

6. The preparation method according to claim 5, characterized in that: The conditions for vacuum concentration in step (2) are: vacuum degree maintained at -0.06 to -1.0 MPa, and heating temperature maintained at 55-85℃; Alternatively, the pasteurization and packaging in step (4) specifically involves placing the solution in a pasteurization device and sterilizing it at 65-70°C for 30 minutes. The cleanliness of the filling environment should reach Class 10,000 to ensure that it meets the national safety requirements. Alternatively, in step (4), the excipients are honey and xanthan gum, with the amounts of honey and xanthan gum being 5%-10% and 0.05%-0.10% of the total weight of the herbal extract, respectively. Add some honey under gentle stirring until completely dissolved. Then, premix xanthan gum with the remaining honey and slowly add it to the system, stirring continuously for 30-40 minutes until the system is uniform and stable. The mixed liquid is then filtered through a 0.45μm microporous membrane.

7. The preparation method according to claim 5, characterized in that: In step (2), concentration must be carried out under reduced pressure at 60°C. The relative density of concentrate II is 1.10-1.15, and it is concentrated to 0.4-0.5 times the original volume of filtrate I. Alternatively, the conditions for decocting in step (2) are: each decoction is 1 hour, the mixed medicinal materials need to be soaked for 30 minutes, the entire process is heated with boiling water at normal pressure, and the temperature is controlled at 95℃; the two decoctions are combined and filtered to avoid loss of active ingredients; Alternatively, the filter membrane filtration conditions in step (3) are: 0.22 μm; the mass ratio of purified water added to concentrate II in step (3) is 1:1 to 2:

1.

8. The preparation method according to claim 5, characterized in that: Concentration must be carried out under reduced pressure at 60°C, and the final concentration has a relative density of 1.10-1.

15.

9. The use of the medicinal and edible herbal compound as described in any one of claims 1 to 3 in the preparation of products for regulating intestinal flora.

10. The application according to claim 9, characterized in that: The recommended dosage of the medicinal and edible herbal compound is 5-10 mL per day, taken twice daily, in the morning and evening.

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