A medicinal and edible traditional Chinese medicine composition containing exovesicle extract for enhancing immunity of a body

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a medicine-food homologous traditional Chinese medicine composition for enhancing immunity of a body, a preparation method and application. Specifically, the medicine-food homologous traditional Chinese medicine composition is made of Chinese wolfberry, raspberry, Chinese yam, gardenia, agastache and Rhabdophis nigrscens. The traditional Chinese medicine composition contains a large number of vesicles, and the particle size of the vesicles is within 1 μm, which is beneficial to rapid uptake of cells. The traditional Chinese medicine composition can significantly increase the number of immune cells of the body, inhibit expression of inflammatory factors of the body, improve the level of interferon IFN-β and IFN-γ of the body, and enhance the innate immunity of the body. In particular, the traditional Chinese medicine composition has a significant improvement effect on low immunity of the body induced by pathogen load, fatigue, emotional stress or emotional obstruction and complications thereof.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a medicinal and edible herbal composition that enhances the body's immunity, its preparation method, and its uses. Background Technology

[0002] The innate immune system is the body's first line of defense against external pathogens. It is activated upon infection, subsequently recognizing and eliminating the pathogens. During this activation process, type I interferon (IFN), particularly IFN-β and IFN-γ signaling, plays a crucial role in the body's anti-infection mechanism. Furthermore, immune cells play a vital role in clearing invading pathogens and correcting immune dysfunction. Therefore, increasing IFN levels and the number of immune cells to enhance immunity is an important strategy for combating pathogen infection.

[0003] Furthermore, the fast pace of modern life and the high levels of work and life pressure lead to a chronic state of tension and anxiety. Emotional stress or emotional distress can easily cause immune system dysfunction. At the same time, most modern people are in a state of chronic fatigue or sub-fatigue. Fatigue also weakens the immune system, reducing the body's ability to resist external pathogens. Summary of the Invention

[0004] Therefore, this invention selects medicinal and edible herbs for scientific formulation to research novel, effective, low-toxicity, simple, and low-cost traditional Chinese medicine compound formulas that enhance immunity. Simultaneously, it provides preparation methods and applications, thereby developing a medicinal and edible herbal composition for enhancing the body's immunity, along with its preparation method and applications.

[0005] Specifically, this invention provides a compound of Chinese medicinal and edible herbs composed of wolfberry, raspberry, alpinia oxyphylla, gardenia, black sedge, and patchouli, which aims to improve the body's immunity, especially against immune dysfunction caused by pathogens, and for the use of herbs that reduce immune function due to emotional stress or fatigue.

[0006] In particular, experimental studies have shown that traditional Chinese medicine formulas containing *Zaocys dhumnades* and *Pogostemon cablin* are more effective in enhancing the body's immune function than those containing only *Lycium barbarum*, *Raspberry*, *Alpinia oxyphylla*, and *Gardenia jasminoides*, or those containing only *Zaocys dhumnades* and *Pogostemon cablin*. That is, *Lycium barbarum*, *Raspberry*, *Alpinia oxyphylla*, and *Gardenia jasminoides*, combined with *Zaocys dhumnades* and *Pogostemon cablin*, have a synergistic effect in enhancing the body's immune function.

[0007] To solve the above technical problems, the present invention is achieved through the following technical solution:

[0008] A first aspect of the present invention provides a traditional Chinese medicine composition that is both food and medicine and has the function of enhancing immunity.

[0009] Specifically, the raw materials for preparing the traditional Chinese medicine composition, by weight, include: 1-50 parts of wolfberry; 1-50 parts of raspberry; 1-50 parts of alpinia oxyphylla; 3-27 parts of gardenia; 5-40 parts of black sedge; and 5-35 parts of patchouli.

[0010] Further, the raw materials for preparing the traditional Chinese medicine composition are preferably: 10-30 parts of wolfberry; 10-30 parts of raspberry; 10-30 parts of alpinia oxyphylla; 3-12 parts of gardenia; 5-20 parts of black sedge; and 5-20 parts of patchouli.

[0011] Furthermore, the raw materials for preparing the traditional Chinese medicine composition are preferably: 30 parts of wolfberry; 10 parts of raspberry; 10 parts of alpinia oxyphylla; 3 parts of gardenia; 5 parts of black sedge; and 5 parts of patchouli, by weight.

[0012] Furthermore, the raw materials for preparing the traditional Chinese medicine composition are preferably: 10 parts of wolfberry; 10 parts of raspberry; 10 parts of alpinia oxyphylla; 3 parts of gardenia; 5 parts of black sedge; and 6 parts of patchouli, by weight.

[0013] A second aspect of the present invention provides a method for preparing a medicinal and edible herbal composition that enhances immunity.

[0014] Specifically, the preparation method of the traditional Chinese medicine composition includes the following steps: weighing wolfberry, raspberry, alpinia oxyphylla, gardenia, zaocys dhumnades and agastache according to the selected weight proportions, mixing them, and soaking the medicinal materials in distilled water for 30-60 minutes at a material-to-liquid ratio of 1:10 to 1:50. Then, transferring the medicinal materials and their soaking liquid to a traditional Chinese medicine clay pot for decoction, combining the decoctions, centrifuging at 2,000×g at 4 ℃ for 30-60 minutes, and transferring the supernatant to a new centrifuge tube for centrifugation at 12,000×g at 4 ℃ for 30-60 minutes. Extracting the outer vesicles from the supernatant using conventional extraction methods.

[0015] Furthermore, the preferred method for preparing the traditional Chinese medicine composition is as follows: weigh wolfberry, raspberry, alpinia oxyphylla, gardenia, patchouli, and zaocys dhumnades according to the selected weight proportions, mix them, and soak the medicinal materials in distilled water for 30 minutes at a material-to-liquid ratio of 1:10. Then, transfer the medicinal materials and their soaking liquid to a traditional Chinese medicine clay pot for decoction, combine the decoctions, centrifuge at 2,000×g at 4 ℃ for 30 minutes, transfer the supernatant to a new centrifuge tube, centrifuge at 12,000×g at 4 ℃ for 60 minutes, and extract the outer vesicles from the supernatant using conventional extraction methods.

[0016] Furthermore, the method for extracting exovesicles is selected from one or more of the following: ultracentrifugation, ultrafiltration, affinity chromatography, or precipitation.

[0017] Furthermore, the preferred method for extracting the outer vesicles is ultracentrifugation, with the preferred ultracentrifugation conditions being a rotation speed of 110,000×g-150,000×g, a centrifugation temperature of 4 ℃, and a centrifugation time of 2-6 hours.

[0018] Furthermore, the preferred ultracentrifugation conditions for extracting the outer vesicles are: rotation speed 110,000 × g, centrifugation temperature 4 ℃, and centrifugation time 4 hours.

[0019] The vesicle particle size of the traditional Chinese medicine compound decoction obtained by this invention is 1-1000 nm.

[0020] Furthermore, the vesicle particle size of the decoction of traditional Chinese medicine is preferably 30-200 nm.

[0021] A third aspect of the present invention provides the use of a traditional Chinese medicine composition that is both food and medicine in the preparation of a medicament to enhance the body's immunity.

[0022] Specifically, enhancing immunity refers to regulating the number of immune cells in the body and increasing the level of innate immune factors;

[0023] Furthermore, the regulation of the number of immune cells in the body refers to the regulation of one or more of the following: white blood cells, lymphocytes, monocytes, neutrophils, eosinophils, and basophils.

[0024] Furthermore, the increase in the body's innate immune factor levels refers to increasing one or more of IFNα, IFNβ, and IFNγ.

[0025] The immune enhancement described in this invention refers to enhancing the body's immunity when the body's immunity is insufficient;

[0026] Specifically, it refers to one or more of the following: when the body is infected with pathogens, resulting in insufficient immunity, or when the body's immunity is low due to fatigue, emotional stress, or emotional distress.

[0027] Furthermore, the pathogens that infect the body refer to one or more of the following: influenza virus, common coronavirus, novel coronavirus (COVID-19), SARS virus, MERS virus, hepatitis C virus, Japanese encephalitis virus, rhinovirus, poliovirus, Coxsackie virus, dengue virus, rotavirus, Ebola virus, HIV or Marburg virus, Mycobacterium tuberculosis, Legionella pneumophila, pathogenic Escherichia coli, Salmonella typhimurium, Streptococcus flexneri, Group B streptococci, Staphylococcus aureus, Streptococcus pneumoniae, Candida albicans, Aspergillus fumigatus, Chlamydia trachomatis, and Chlamydia pneumoniae.

[0028] Alternatively, in the above-mentioned products, the drug is made with conventional excipients and according to conventional processes, and the dosage form of the drug is selected from one of liquid dosage form, solid dosage form, or semi-solid dosage form.

[0029] Preferably, the dosage form of the drug is a gel, cream, tablet, capsule, powder, mixture, pill, granule, oral liquid, syrup, decoction, suppository, aerosol, plaster, ointment, injection, spray, liniment, tincture, wet compress, paste or lotion.

[0030] In a specific embodiment of the present invention, by administering a combination of medicinal and edible herbs, pathogen infection can be effectively inhibited, the levels of interferon IFN-β and IFNγ can be increased, lung damage caused by pathogens can be reversed, and the imbalance of immune cell numbers caused by pathogen infection, fatigue, emotional stress or emotional distress can be restored.

[0031] Compared with the prior art, the present invention has the following advantages:

[0032] (1) This invention uses Chinese medicinal herbs such as wolfberry, raspberry, alpinia oxyphylla, and gardenia, combined with agastache and zaocys dhumnades to form a Chinese medicine compound, and develops a drug composition with synergistic effect, good efficacy, small dosage, few toxic side effects, low cost, and also has the effects of enhancing immunity, resisting pathogen infection, and inhibiting inflammation.

[0033] (2) This invention is the first to propose vesicles in the decoction of traditional Chinese medicine that is both food and medicine. Pharmacological experiments have shown that the vesicles in the compound of this invention have significant effects in enhancing immunity, resisting pathogen infection, and inhibiting inflammation, and have no toxic side effects, and have good clinical application prospects.

[0034] (3) The vesicles prepared from the traditional Chinese medicine compound of the present invention can all be produced by mature methods, making the traditional Chinese medicine compound vesicles of the present invention easy to produce on a large industrial scale. In addition, by adding a pharmaceutically acceptable carrier, the traditional Chinese medicine composition of the present invention can be made into a conventional preparation, which makes the drug efficacy stable and convenient to use. Attached Figure Description

[0035] Figure 1 Results of determination of vesicle size and quantity in traditional Chinese medicine compositions that are both food and medicine.

[0036] Figure 2 Lung index of each group of experimental animals.

[0037] Figure 3 IL-1β levels in each group of experimental animals. Compared to the Mock group, p <0.001; # , ## These respectively indicate that, compared to the H1N1 group, p <0.05 and p <0.01.

[0038] Figure 4IFN-β levels in each group of experimental animals. *** Compared to the Mock group, p <0.001; ### This indicates that compared to the H1N1 group, p <0.001.

[0039] Figure 5 The number of lymphocytes, monocytes, and neutrophils in each group of experimental animals. Compared to the Control group, p <0.001; # , ## and ### These represent the differences compared to the H1N1 group. p <0.05, p <0.01 and p <0.001. Detailed Implementation

[0040] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0041] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0042] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the experimental materials used in the following embodiments are commercially available products.

[0043] Example 1: Effects of a combination of medicinal and edible herbs on the body's immunity

[0044] 1. Preparation of extracts from traditional Chinese medicine compositions:

[0045] Weigh out 10 g of wolfberry, 10 g of raspberry, 10 g of alpinia oxyphylla, and 3 g of gardenia according to the selected weight proportions. Mix them and soak in 400 mL of distilled water for 30 minutes. Then, transfer the herbs and their soaking liquid to a traditional Chinese medicine clay pot for decoction. Boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the first decoction. Add 200 mL of pure water to the clay pot, boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the second decoction. Finally, add 100 mL of pure water to the clay pot, boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the third decoction. Combine the three decoctions, concentrate under low temperature and reduced pressure, and dry to obtain the traditional Chinese medicine composition extract 1.

[0046] Weigh out 6 g of agastache rugosa and 5 g of zaocys dhumnades according to the selected proportions. Mix them and soak in 100 mL of distilled water for 30 minutes. Then transfer the herbs and their soaking liquid to a traditional Chinese medicine clay pot for decoction. Boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the first decoction. Add 50 mL of pure water to the clay pot, boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the second decoction. Finally, add 50 mL of pure water to the clay pot, boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the third decoction. Combine the three decoctions, concentrate under low temperature and reduced pressure, and dry to obtain the traditional Chinese medicine composition extract 2.

[0047] Weigh out 10 g of wolfberry, 10 g of raspberry, 10 g of alpinia oxyphylla, 6 g of agastache rugosa, 3 g of gardenia, and 5 g of zaocys dhumnades according to the selected weight proportions. Mix them and soak in 500 mL of distilled water for 30 minutes. Then transfer the herbs and their soaking liquid to a traditional Chinese medicine clay pot for decoction. Boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the first decoction. Add 300 mL of pure water to the clay pot, boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the second decoction. Finally, add 100 mL of pure water to the clay pot, boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the third decoction. Combine the three decoctions, concentrate under low temperature and reduced pressure, and dry to obtain the traditional Chinese medicine composition extract 3.

[0048] 2. Traditional Chinese medicine compound enhances the immunity of virus-infected mice.

[0049] Male BALB / c mice aged 6-8 weeks were selected and divided into 5 groups: a normal control group, a model control group, and three groups of traditional Chinese medicine extracts (extract 1, extract 2, and extract 3, each at a dose of 30 mg / kg), with 6 mice in each group. Mice in the traditional Chinese medicine extract groups were administered the corresponding extracts via gavage, while mice in the other groups were administered an equal volume of distilled water via gavage. The administration was continued for 7 days. On the 3rd day of administration, except for the normal control group, all other groups were infected with the 2-fold LD50 via nasal drop. 50 Influenza virus strain PR8 (H1N1) with viral load. On day 5 after H1N1 infection via nasal drop, mice in each group were anesthetized with isoflurane, and mouse serum was collected for ELISA to detect IFN-β levels.

[0050] The synergy index is determined using the Jin Zhengjun q-value method, and the q-value is obtained by the following formula: q=E A+B / (E A +E B -E A ×E B In the formula, E A EB E A+B These represent the percentage increase in IFN-β levels relative to the model group in drug A, drug B, and the combination of the two drugs, respectively. q < 1 indicates an antagonistic effect after the two drugs are used together; q > 1 indicates a synergistic effect after the two drugs are used together; and q = 1 indicates an additive effect after the two drugs are used together.

[0051] Data were plotted using Graphpad Prism software (version 8) and expressed as mean ± SD. Statistical analysis was performed using SPSS software (version 25) through one-way ANOVA, and the statistical data conformed to the standard of a normal distribution with similar variances.

[0052] Table 1: Traditional Chinese medicine compound formulas that promote interferon secretion (based on both medicinal and edible ingredients)

[0053] Note: Compared to the Mock group p <0.001; #，## These represent the differences compared to the H1N1 group. p <0.05 and p <0.01.

[0054] The experimental results are shown in Table 1. All three groups of herbal extracts significantly promoted IFN-β secretion in vivo. However, at the same dosage, the promoting effects of herbal extracts 1 and 2 on IFN-β secretion were lower than those of herbal extract 3. Furthermore, calculations based on the synergistic effect formula showed that herbal extract 3 exhibited a significant synergistic effect on promoting IFN-β secretion compared to herbal extracts 1 and 2. These results indirectly demonstrate that the effect of the herbal compound provided by this invention in enhancing the body's immunity is not due to the action of one or a few herbs, but rather the result of the synergistic and combined effects of all the herbs.

[0055] Example 2: Preparation of exovesicle extract from traditional Chinese medicine composition

[0056] Weigh out 10 g of wolfberry, 10 g of raspberry, 10 g of alpinia oxyphylla, 6 g of agastache rugosa, 3 g of gardenia, and 5 g of zaocys dhumnades according to the selected weight proportions. Mix them and add 500 mL of distilled water to soak for 30 minutes. Then, transfer the herbs and their soaking liquid to a traditional Chinese medicine clay pot for decoction. Boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the first decoction. Add 300 mL of pure water to the clay pot, boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the second decoction. Finally, add 100 mL of pure water to the clay pot, boil over high heat for 30 minutes, then simmer over low heat for 10 minutes, collecting the third decoction. Combine the three decoctions and centrifuge at 2,000 × g at 4 °C for 30 minutes. Transfer the supernatant to a new centrifuge tube and centrifuge at 12,000 × g at 4 °C for 60 minutes. The collected supernatant was centrifuged at 110,000 × g at 4 °C for 4 hours. The supernatant was then completely removed. The precipitate was resuspended in 1 mL of PBS, and the suspension was filtered through a 0.22 μm filter. The filtrate was collected in a new 1.5 mL centrifuge tube.

[0057] The particle size and number of extracted vesicles were determined using NanoSight technology (Merkel technologies LTD, Israel).

[0058] Experimental results are as follows Figure 1 As shown, the vesicle size of the medicinal and edible herbal composition of the present invention is concentrated in the range of 30-180 nm, with a median particle size of 120 nm. Furthermore, as can be seen from the figure, the medicinal and edible herbal composition is rich in vesicles.

[0059] Example 3: Protective effect of the herbal composition vesicles of the present invention on mice infected with influenza virus.

[0060] 1. The herbal composition vesicles of this invention reduce the lung index in mice infected with influenza virus.

[0061] Male BALB / c mice aged 6-8 weeks were selected and divided into four groups: a normal control group, a model control group, a traditional Chinese medicine (TCM) extract group (30 mg / kg, extract 3 prepared in Example 1), and a TCM vesicle group (50 μg, prepared in Example 2), with 6 mice in each group. Mice in the TCM extract group were administered the extract via conventional gavage, mice in the TCM vesicle group were administered 30 μL of TCM vesicles intranasally, and the other groups were administered an equal volume of distilled water via gavage. The administration was continued for 7 days. On the 3rd day of administration, except for the normal control group, all other groups were infected with a 2-fold LD50 via nasal drop. 50The viral load of influenza virus strain PR8 (H1N1) was measured. On day 5 after nasal infection with H1N1, mouse body weight was measured and recorded. Immediately afterwards, mice in each group were anesthetized with isoflurane, and lung tissue was harvested and weighed to calculate the lung index. The lung index was calculated as follows: Lung Index = Lung wet weight (g) / Body weight (g) × 100%.

[0062] Data were plotted using Graphpad Prism software (version 8) and expressed as mean ± SD. Statistical analysis was performed using SPSS software (version 25) through one-way ANOVA, and the statistical data conformed to the standard of a normal distribution with similar variances.

[0063] Experimental results are as follows Figure 2 As shown, the lung index of the model control group was significantly higher than that of the normal control group. After protection with the vesicles of the traditional Chinese medicine composition of this invention, the lung index of mice was significantly reduced, and was superior to that of the group treated with the extract of the traditional Chinese medicine composition.

[0064] 2. The composition of the present invention inhibits the secretion of inflammatory factors induced by influenza virus.

[0065] Male BALB / c mice aged 6-8 weeks were selected and divided into four groups: a normal control group, a model control group, a traditional Chinese medicine (TCM) extract group (30 mg / kg, extract 3 prepared in Example 1), and a TCM vesicle group (50 μg, prepared in Example 2), with 6 mice in each group. Mice in the TCM extract group were administered the extract by gavage, mice in the TCM vesicle group were administered 30 μL of vesicles intranasally, and mice in the other groups were administered an equal volume of distilled water by gavage. The administration was continued for 7 days. On the 3rd day of administration, except for the normal control group, all other groups were infected with a 2-fold LD50 via nasal drop. 50 Influenza virus strain PR8 (H1N1) with viral load. On day 5 after H1N1 infection via nasal drop, mice in each group were anesthetized with isoflurane, and mouse serum was collected for ELISA detection of IL-1β levels.

[0066] Data were plotted using Graphpad Prism software (version 8) and expressed as mean ± SD. Statistical analysis was performed using SPSS software (version 25) through one-way ANOVA, and the statistical data conformed to the standard of a normal distribution with similar variances.

[0067] Experimental results are as follows Figure 3 As shown, the vesicles of the traditional Chinese medicine composition of the present invention can significantly inhibit the level of IL-β, and its inhibition of IL-β secretion is superior to that of the extract of the traditional Chinese medicine composition.

[0068] Example 4: The herbal composition vesicles of the present invention enhance the immunity of virus-infected mice.

[0069] Male BALB / c mice aged 6-8 weeks were selected and divided into four groups: a normal control group, a model control group, a traditional Chinese medicine (TCM) extract group (30 mg / kg, extract 3 prepared in Example 1), and a TCM vesicle group (50 μg, prepared in Example 2), with 6 mice in each group. Mice in the TCM extract group were administered the extract via gavage, mice in the TCM vesicle group were administered 30 μL of vesicles intranasally, and the other groups were administered an equal volume of distilled water via gavage. Treatment continued for 7 days. On the third day of treatment, except for the normal control group, all other groups were infected with a 2-fold LD50 via nasal drop. 50 Influenza virus strain PR8 (H1N1) with viral load. On day 5 after H1N1 infection via nasal drop, mice in each group were anesthetized with isoflurane, and mouse serum was collected for ELISA to detect IFN-β levels.

[0070] Data were plotted using Graphpad Prism software (version 8) and expressed as mean ± SD. Statistical analysis was performed using SPSS software (version 25) through one-way ANOVA, and the statistical data conformed to the standard of a normal distribution with similar variances.

[0071] Experimental results are as follows Figure 4 As shown, the vesicles of the traditional Chinese medicine composition of the present invention promote the secretion of IFN-β, and their effect is better than that of the extract of the traditional Chinese medicine composition.

[0072] Example 5: The traditional Chinese medicine composition of the present invention enhances emotional stress immunity.

[0073] Male C57 / BL6 mice aged 6-8 weeks were selected and divided into four groups: a normal control group, a model control group, a traditional Chinese medicine (TCM) extract group (30 mg / kg, extract 3 prepared in Example 1), and a TCM vesicle group (100 μg, prepared in Example 2), with 6 mice in each group. Mice in the TCM extract group were administered the extract by gavage, while mice in the other groups were administered an equal volume of distilled water by gavage. Both groups were administered the extracts for 21 consecutive days. Mice in the TCM vesicle group received 200 μL of vesicles via tail vein injection every other day for 21 days. One hour after each day's administration, the mice were restrained using 50 mL centrifuge tubes for 4 hours daily for 21 consecutive days. Four hours after the final restraint, mice in each group were anesthetized with isoflurane, and plasma was collected to detect the number of lymphocytes, neutrophils, and monocytes, thus characterizing the mice's immune level.

[0074] Data were plotted using Graphpad Prism software (version 8) and expressed as mean ± SD. Statistical analysis was performed using SPSS software (version 25) through one-way ANOVA, and the statistical data conformed to the standard of a normal distribution with similar variances.

[0075] Experimental results are as follows Figure 5 As shown, the herbal composition of the present invention significantly increases the number of lymphocytes, monocytes and neutrophils.

[0076] Example 6: The herbal composition of the present invention enhances the immunity of fatigued mice.

[0077] Male ICR mice aged 6-8 weeks were selected and divided into four groups: a normal control group, a model control group, a traditional Chinese medicine (TCM) extract group (30 mg / kg, extract 3 prepared in Example 1), and a TCM vesicle group (100 μg, prepared in Example 2), with 6 mice in each group. Mice in the TCM extract group were administered the extract by gavage, while mice in the other groups were administered an equal volume of distilled water by gavage. This treatment was repeated for 21 consecutive days. Mice in the TCM vesicle group received 200 μL of vesicles via tail vein injection every other day for 21 days. Thirty minutes after the last administration, mice in the model group, TCM extract group, and TCM vesicle group underwent a 7% weight-bearing swimming exercise with their tails at a water temperature of (25±3)℃ and a water depth of 30 cm. If a mouse remained motionless, the surrounding water was immediately stirred to force it to continue swimming. Exhaustion was determined when a mouse could not resurface within 10 seconds of its head being completely submerged and its righting reflex disappeared. The time from the start of swimming to exhaustion was used as the standard for counting the weighted swimming time of mice. Mice in the normal control group swam for 30 minutes without weight, then were removed and dried. After a 10-minute rest, mice in each group were anesthetized with isoflurane, and their plasma was collected to detect the number of monocytes and neutrophils.

[0078] Data are expressed as mean ± SD. One-way ANOVA was performed using SPSS software (version 25), and the statistical data conformed to the standard of a normal distribution with similar variances.

[0079] Table 2: Traditional Chinese Medicine Composition Extracts and Vesicles Enhance Immunity in Fatigue-Stricken Mice

[0080] Note: , These represent the differences compared to the normal control group. p <0.05 and p <0.001; # , ## , ### These represent the differences compared to the model control group. p <0.05, p <0.01 and p <0.001.

[0081] The experimental results are shown in Table 2. The herbal composition vesicles of the present invention can significantly increase the number of monocytes and lymphocytes, enhance the immunity of fatigued mice, and increase the swimming time of mice under load.

[0082] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A medicinal and edible herbal composition for enhancing the body's immunity, characterized in that: The raw materials for preparing the traditional Chinese medicine composition are, by weight, 10 parts of wolfberry, 10 parts of raspberry, 10 parts of alpinia oxyphylla, 3 parts of gardenia, 5 parts of black sedge, and 6 parts of patchouli.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition comprises an external vesicle extract obtained by decocting the raw materials used to prepare the traditional Chinese medicine composition.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The vesicles have a particle size of 1-1000 nm.

4. The traditional Chinese medicine composition according to claim 3, characterized in that: The vesicles have a particle size of 30-200 nm.

5. The traditional Chinese medicine composition according to claim 1, characterized in that: Enhancing the body's immunity refers to increasing the number of immune cells and raising the levels of innate immune factors interferon IFN-β and IFN-γ.

6. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition targets immune dysfunction caused by pathogen load, fatigue, emotional stress, or emotional distress.

7. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 6, characterized in that: The preparation method includes the following steps: weigh wolfberry, raspberry, alpinia oxyphylla, gardenia, zaocys dhumnades and agastache rugosa according to the selected weight proportions, mix them, and soak the medicinal materials in distilled water for 30-60 minutes at a material-to-liquid ratio of 1:10 to 1:

50. Then transfer the medicinal materials and their soaking liquid to a traditional Chinese medicine clay pot for decoction. Combine the decoctions and centrifuge at 2,000×g at 4 ℃ for 30-60 minutes. Transfer the supernatant to a new centrifuge tube and centrifuge at 12,000×g at 4 ℃ for 30-60 minutes. Collect the supernatant and centrifuge at 110,000×g at 4 ℃ for 4 hours. Remove the supernatant.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicine that enhances the body's immunity.

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