Traditional Chinese medicine composition for regulating intestinal and liver skin axes and relieving senescence and preparation method of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for regulating intestinal and liver skin axes and relieving aging and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises the following components in percentage by weight: 15-25% of pears, 10-15% of fish gelatin, 8-12% of wheat leaves, 8-12% of Chinese wolfberry fruits, 6-10% of rhizoma polygonati, 5-10% of radix salviae miltiorrhizae, 5-8% of poria cocos, 4-8% of Chinese yams and 2-5% of roses. According to the traditional Chinese medicine composition for regulating intestinal and liver skin axes and relieving senescence and the preparation method thereof provided by the invention, endotoxin accumulation is improved by regulating intestinal microecology; oxidation resistance (SOD and GSH levels are improved, and ROS is eliminated); the immune state of the skin is regulated, and inflammatory factors (TNF-alpha and IL-6) are reduced; collagen is supplemented, and skin repair and regeneration are promoted; the microcirculation is improved, and the nutrition supply and metabolic function of the skin are enhanced.

Description

Technical Field

[0001] The present invention relates to the intersection of traditional Chinese medicine and functional food, and in particular to a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging, and a preparation method thereof. Background Art

[0002] Studies in recent years have shown that skin health is not only affected by the external environment, such as ultraviolet rays and pollution, but is also closely related to the body's metabolism and immune regulatory systems. Among them, the composition of the intestinal flora, the metabolism and detoxification function of the liver, and the skin barrier repair ability are interconnected to form the "gut-liver-skin axis." Studies have found that an imbalance in the intestinal flora can damage the intestinal barrier through the reduction of short-chain fatty acids and the accumulation of harmful metabolites, thereby stimulating systemic inflammation. At the same time, as a detoxification center, if the liver is dysfunctional, it will lead to the inability to metabolize oxidative products and endogenous toxins in a timely manner, causing skin inflammation, pigmentation, accelerated collagen loss, and other phenomena, thereby accelerating skin aging. Traditional anti-aging products only focus on a single organ (such as the skin or intestines), ignore the interaction of the gut-liver-skin axis, and cannot block the transmission of aging signals across organs.

[0003] Traditional Chinese Medicine emphasizes that "the lungs govern the skin, the spleen governs transportation and transformation, and the liver governs dispersing and discharging." Harmony among the five internal organs is fundamental for a full Qi and blood, and a radiant complexion. The lungs are closely linked to the skin, dispersing Qi and distributing essence to the skin and regulating the waterways. Lung Yin deficiency can lead to dry skin. The stomach and intestines are the "foundation of acquired constitution." Healthy functioning is the source of Qi and blood production. A dysfunctional spleen prevents the essence of food and water from reaching the skin, resulting in sallowness and sagging. The liver stores blood and regulates dispersing and discharging, regulating emotions and promoting smooth metabolism. Liver blood deficiency leads to a dull complexion, while liver stagnation and the transformation of fire into acne. Therefore, addressing multiple aspects of the body, including regulating the stomach and intestines, nourishing the liver and blood, and moistening the lungs and nourishing Yin, has the potential to improve the skin's metabolic environment through internal regulation and achieve anti-aging and cosmetic benefits. However, currently available Traditional Chinese Medicine formulas lack precise combinations tailored to the complex etiology of oxidative stress and metabolic disorders in the modern population, failing to meet anti-aging needs.

[0004] Therefore, it is necessary to provide a Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging and a preparation method thereof to solve the above technical problems. Summary of the Invention

[0005] The present invention provides a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging, and a preparation method thereof, which solves the problems that traditional anti-aging products only focus on a single organ, ignore the interaction of the gut-liver-skin axis, and cannot block the cross-organ transmission of aging signals; and that currently available traditional Chinese medicine prescriptions lack precise compatibility for the complex causes of oxidative stress and metabolic disorders in modern people, and cannot meet anti-aging needs.

[0006] To solve the above technical problems, the present invention provides a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging, which comprises the following ingredients by weight:

[0007] Pear 15%-25%, fish glue 10%-15%, wheat grass 8%-12%, wolfberry 8%-12%, polygonatum 6%-10%, salvia miltiorrhiza 5%-10%, poria 5%-8%, yam 4%-8%, rose 2%-5%.

[0008] Preferably, the dosage form of the composition includes granules, capsules, freeze-dried powder, functional beauty drinks or tablets.

[0009] To solve the above problems, the present invention also provides a method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging, comprising the following steps:

[0010] S1. Raw material pretreatment: beating pears, soaking and chopping fish glue, and coarse powdering of other medicinal materials;

[0011] S2, decoction extraction: decoct the medicinal materials except fish glue with water;

[0012] S3, dissolve the fish glue and mix;

[0013] S4, concentration and drying: vacuum concentration, spray drying;

[0014] S5. Preparation molding: Different dosage forms can be made according to needs.

[0015] Preferably, a boiling device is required in the S2 step, and the boiling device includes a tank body, a feed port is fixedly installed on the top of the tank body, a top cover is threadedly connected to the top of the outer side of the feed port, a cloth bag is fixedly installed on the top of the inner side of the tank body, a lifting motor is fixedly installed on the back of the tank body, a threaded rod is fixedly installed on the output end of the lifting motor, a threaded sleeve is threadedly connected to the outer side of the threaded rod, a connecting plate is fixedly installed on the top of the threaded sleeve, sliding rods are fixedly installed at both ends of the bottom of the connecting plate, extrusion plates are fixedly installed on the bottoms of the two sliding rods, and a heating component is fixedly installed inside the tank body.

[0016] Preferably, the cloth bag is arranged at the bottom of the feed port, and the bottom of the cloth bag is arranged at the top of the extrusion plate.

[0017] Preferably, the two sliding rods are both slidably connected to the inside of the top of the tank body.

[0018] Preferably, a stirring motor is fixedly mounted on the bottom of the tank body, a rotating shaft is fixedly mounted on the output end of the stirring motor, and a plurality of stirring blades are fixedly mounted on the outer side surface of the rotating shaft.

[0019] Preferably, the plurality of stirring blades are all arranged on the inner side of the tank body and located at the bottom of the extrusion plate.

[0020] Preferably, a water outlet valve is fixedly installed on the bottom of the front side of the tank body.

[0021] Preferably, support frames are fixedly installed around the bottom of the tank body.

[0022] Compared with related technologies, the Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging and the preparation method thereof provided by the present invention have the following beneficial effects:

[0023] The present invention provides a traditional Chinese medicine composition for regulating the intestinal-liver-skin axis and alleviating aging, and a preparation method thereof. The composition improves endotoxin accumulation by regulating intestinal microecology; provides anti-oxidation (increasing SOD and GSH levels and clearing ROS); regulates skin immunity and reduces inflammatory factors (TNF-α and IL-6); supplements collagen and promotes skin repair and regeneration; improves microcirculation and enhances skin nutrition supply and metabolic function;

[0024] This combination is derived from Traditional Chinese Medicine theory and is unique in that it integrates for the first time the triple synergistic mechanism of "pear nourishing the lungs + fish glue replenishing essence + wheat grass leaves clearing the liver." The ratio of pear (15%-25%) to fish glue (10%-15%) fills a gap in existing patents. It also clearly defines the regulation of the "intestine-liver-skin axis" by the traditional Chinese medicine compound, breaking through the traditional single-organ anti-aging model.

[0025] The compound Chinese medicine composition of the present invention is safe and non-toxic, has natural ingredients, is rich in collagen, antioxidant ingredients and prebiotics, and highlights the overall anti-aging strategy of "starting from the intestines and liver and nourishing the skin from the outside". It can not only delay skin aging, but also regulate intestinal health, resist fatigue, and improve qi and blood. It has broad market promotion and clinical transformation value. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A schematic structural diagram of a preferred embodiment of a decoction device for use in the preparation of a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging provided by the present invention;

[0027] Figure 2 for Figure 1 Another perspective structural diagram shown;

[0028] Figure 3 for Figure 1 The cross-sectional structural diagram shown;

[0029] Figure 4 for Figure 3 Schematic diagram of the extruded plate structure from top view.

[0030] Numbers in the figure: 1. Tank body, 11. Support frame, 12. Water outlet valve, 13. Feed port, 14. Top cover, 2. Stirring motor, 21. Rotating shaft, 22. Stirring blade, 3. Lifting motor, 31. Threaded rod, 32. Threaded sleeve, 33. Connecting plate, 34. Sliding rod, 35. Extrusion plate, 4. Cloth bag, 5. Heating component. DETAILED DESCRIPTION

[0031] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0032] Example 1

[0033] Please refer to Figure 1 、 Figure 2 、 Figure 3 、 Figure 4 ,in, Figure 1 A schematic structural diagram of a preferred embodiment of a decoction device for use in the preparation of a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging provided by the present invention; Figure 2 for Figure 1 Another perspective structural diagram shown; Figure 3 for Figure 1 The cross-sectional structural diagram shown; Figure 4 for Figure 3 Schematic diagram of the extruded plate structure from top view.

[0034] A traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging and a preparation method thereof, comprising the following ingredients by weight:

[0035] Pear 15%-25%, fish glue 10%-15%, wheat grass 8%-12%, wolfberry 8%-12%, polygonatum 6%-10%, salvia miltiorrhiza 5%-10%, poria 5%-8%, yam 4%-8%, rose 2%-5%.

[0036] The dosage form of the composition includes granules, capsules, freeze-dried powder, functional beauty drinks or tablets.

[0037] To solve the above problems, the present invention also provides a method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging, comprising the following steps:

[0038] S1. Raw material pretreatment: beating pears, soaking and chopping fish glue, and coarse powdering of other medicinal materials;

[0039] S2, decoction extraction: decoct the medicinal materials except fish glue with water;

[0040] S3, dissolve the fish glue and mix;

[0041] S4, concentration and drying: vacuum concentration, spray drying;

[0042] S5. Preparation molding: Different dosage forms can be made according to needs.

[0043] Among them, pear and fish glue constitute the main medicine: pear moistens the lungs and produces fluid, fish glue nourishes yin and replenishes essence, and together they achieve the effect of "gold and water coexisting" (tonifying both the lungs and kidneys); wolfberry and polygonatum constitute the ministerial medicine: wolfberry nourishes the liver and improves eyesight, polygonatum nourishes the spleen and benefits the kidneys, and strengthens the source of essence and blood biochemistry; wheat vine leaves plus salvia miltiorrhiza and poria constitute the adjuvant medicine: wheat vine leaves clear the liver and detoxify, salvia miltiorrhiza activates blood circulation and dredges the meridians, and poria strengthens the spleen and removes dampness, forming a "clear-activate-benefit" synergy; yam and rose constitute the guiding medicine: yam harmonizes the spleen and stomach, rose soothes the liver and regulates qi, guides the medicine to the meridians and harmonizes the whole prescription; it is aimed at the "liver and kidney yin deficiency, lung dryness and blood stasis" type of constitution, and is suitable for people with dry skin, fatigue, premature aging, and metabolic disorders (such as hyperglycemia and chronic inflammation).

[0044] A boiling device is required in the S2 step, and the boiling device includes a tank body 1, a feed port 13 is fixedly installed on the top of the tank body 1, a top cover 14 is threadedly connected to the top of the outer side of the feed port 13, a cloth bag 4 is fixedly installed on the top of the inner side of the tank body 1, a lifting motor 3 is fixedly installed on the back of the tank body 1, a threaded rod 31 is fixedly installed on the output end of the lifting motor 3, a threaded sleeve 32 is threadedly connected to the outer side of the threaded rod 31, a connecting plate 33 is fixedly installed on the top of the threaded sleeve 32, sliding rods 34 are fixedly installed at both ends of the bottom of the connecting plate 33, and extrusion plates 35 are fixedly installed at the bottom of the two sliding rods 34, and a heating component 5 is fixedly installed inside the tank body 1.

[0045] The cloth bag 4 is disposed at the bottom of the feed port 13 , and the bottom of the cloth bag 4 is disposed on the top of the extrusion plate 35 .

[0046] The two sliding rods 34 are both slidably connected to the inside of the top of the tank body 1.

[0047] A stirring motor 2 is fixedly mounted on the bottom of the tank body 1 , a rotating shaft 21 is fixedly mounted on the output end of the stirring motor 2 , and a plurality of stirring blades 22 are fixedly mounted on the outer side of the rotating shaft 21 .

[0048] The plurality of stirring blades 22 are all disposed on the inner side of the tank body 1 and located at the bottom of the squeezing plate 35 .

[0049] A water outlet valve 12 is fixedly installed at the bottom of the front side of the tank body 1 .

[0050] Support frames 11 are fixedly installed around the bottom of the tank body 1.

[0051] When it is necessary to add water to decoct and extract medicinal materials other than fish glue, first open the top cover 14, put the medicinal materials into the inner side of the tank body 1 through the feeding port 13, and make the medicinal materials be on the inner side of the cloth bag 4, then add water to the interior of the tank body 1, and then start the heating component 5, so that the heating component 5 heats the interior of the tank body 1, thereby achieving the effect of decocting the medicinal materials, and while decocting, the stirring motor 2 can be started, so that the stirring motor 2 drives the rotating shaft 21 and the stirring blade 22 to rotate, so that the stirring blade 22 stirs and mixes the medicinal liquid inside the tank body 1, thereby enhancing the decoction effect;

[0052] After the decoction is finished, the user first starts the lifting motor 3, so that the lifting motor 3 drives the threaded rod 31 to be threadedly connected inside the threaded sleeve 32, so that the top of the threaded sleeve 32 drives the connecting plate 33 to move upward, so that the connecting plate 33 drives the sliding rod 34 to move upward. When the sliding rod 34 moves upward, it can simultaneously drive the squeezing plate 35 to move upward, so that the top of the squeezing plate 35 abuts against the bottom of the cloth bag 4, thereby squeezing the cloth bag 4, so that the medicinal liquid in the medicinal material inside the cloth bag 4 is squeezed out, thereby avoiding waste of the medicinal liquid. After that, the staff opens the water outlet valve 12 to discharge the medicinal liquid;

[0053] When the medicinal material bundle needs to be cleaned later, the staff can open the top cover 14 and then take out the medicinal materials on the inner side of the cloth bag 4.

[0054] By cooperating with each other, the lifting motor 3, the threaded rod 31, the threaded sleeve 32, the connecting plate 33, the sliding rod 34, the squeezing plate 35 and the cloth bag 4, when in use, the squeezing plate 35 squeezes the medicinal materials inside the cloth bag 4, and can squeeze out the medicinal liquid adsorbed in the medicinal materials, thereby avoiding waste of the medicinal liquid.

[0055] Compared with related technologies, the Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging and the preparation method thereof provided by the present invention have the following beneficial effects:

[0056] By regulating intestinal microecology, improving endotoxin accumulation; anti-oxidation (increasing SOD and GSH levels, clearing ROS); regulating skin immunity, reducing inflammatory factors (TNF-α, IL-6); supplementing collagen, promoting skin repair and regeneration; improving microcirculation, enhancing skin nutrition supply and metabolic function;

[0057] This combination is derived from Traditional Chinese Medicine theory and is unique in that it integrates for the first time the triple synergistic mechanism of "pear nourishing the lungs + fish glue replenishing essence + wheat grass leaves clearing the liver." The ratio of pear (15%-25%) to fish glue (10%-15%) fills a gap in existing patents. It also clearly defines the regulation of the "intestine-liver-skin axis" by the traditional Chinese medicine compound, breaking through the traditional single-organ anti-aging model.

[0058] The compound Chinese medicine composition of the present invention is safe and non-toxic, has natural ingredients, is rich in collagen, antioxidant ingredients and prebiotics, and highlights the overall anti-aging strategy of "starting from the intestines and liver and nourishing the skin from the outside". It can not only delay skin aging, but also regulate intestinal health, resist fatigue, and improve qi and blood. It has broad market promotion and clinical transformation value.

[0059] Example 2 (Preparation of Chinese medicine composition dry paste):

[0060] Take 200g pear, 80g fish glue, 60g wheat leaf, 80g wolfberry, 60g polygonatum, 50g salvia miltiorrhiza, 40g poria, 40g yam, 20g rose.

[0061] (1) Raw material pretreatment: Raw material pretreatment

[0062] Pears: Peel and core the pears, crush and pulp them, add cellulase (0.2% w / w) and hydrolyze them at 45°C for 45 minutes. After inactivation, centrifuge and collect the supernatant.

[0063] Fish gelatin: Hydrolyze with a combined enzyme (pepsin: pancreatin = 1:2, pH 2.5, 37°C for 4 hours), inactivate, and collect peptides (molecular weight 1-5 kDa) by ultrafiltration.

[0064] Medicinal material group (Poria, Salvia miltiorrhiza, Poria, Chinese yam, and rose): crushed to 40 mesh, extracted with 60% ethanol (solid-liquid ratio 1:10) with ultrasound assistance (40 kHz) for 30 min, and the filtrate was decompressed to recover ethanol;

[0065] Wheat leaf: Quickly frozen in liquid nitrogen, then ultrafinely ground, and subjected to dynamic circulating water extraction together with wolfberry.

[0066] (2) Dynamic cycle extraction: First decoction: extraction with pure water at 50°C (solid-liquid ratio 1:8), time 1.5 hours, rotation speed 80 rpm; second decoction: extraction with pure water at 45°C (solid-liquid ratio 1:6), time 1 hour, rotation speed 60 rpm; the combined filtrates were coarsely filtered through a 200-mesh filter cloth and then finely filtered through a 0.45 μm membrane.

[0067] (4) Concentration and drying: The filtrate is concentrated to a relative density of 1.20 under reduced pressure and spray-dried (inlet air temperature 150°C, outlet air temperature 80°C) to obtain a Chinese medicine dry paste powder.

[0068] Example 3 (functional beverage):

[0069] The dry powder obtained in Example 2 was added with the prebiotic complex, blueberry concentrate and oligofructose to prepare a functional beverage.

[0070] Embodiment 4 (capsule):

[0071] Mix the dry paste powder and mannitol in proportion, use a wet granulator to make granules, pass through a 16-mesh screen to form granules, place them in a hot air circulation drying oven, and dry them at 50°C to a moisture content of ≤3%. After the granules are granulated, seal them in aluminum-plastic composite film bags.

[0072] Example 5 (tablet):

[0073] Add the dry paste powder and pregelatinized starch to a trough mixer and mix at low speed for 20 minutes. Add talc and continue mixing for 5 minutes. Use a rotary tablet press to compress the tablets to a weight of 0.6 g / tablet.

[0074] Example 6: Animal experiments verify the anti-aging effect of the composition of the present invention

[0075] 1. Experimental purpose:

[0076] Verify whether this Chinese medicine composition has the effects of anti-aging, beauty and skin care, regulating intestinal microecology and improving skin condition by regulating the intestine-liver-skin axis.

[0077] 2. Experimental methods:

[0078] a. Experimental model and grouping:

[0079] Sixty 8-week-old SPF female C57BL / 6 mice were selected and randomly divided into 4 groups, with 15 mice in each group: normal control group (blank), model control group (D-galactose skin aging model), positive control group (vitamin C + collagen), low-dose group of Chinese medicine composition (0.5 g / kg / d), medium-dose group of Chinese medicine composition (1.0 g / kg / d), and high-dose group of Chinese medicine composition (2.0 g / kg / d).

[0080] b. Modeling method:

[0081] Groups 2 to 4 of mice were subcutaneously injected with D-galactose (100 mg / kg / d) for 6 consecutive weeks to induce skin aging models. The control group was injected with an equal volume of normal saline.

[0082] c. Intervention methods:

[0083] Simultaneously with modeling, Group 4 was gavaged daily with an aqueous solution of the composition of the present invention (converted to an average human dose), the positive control group was given vitamin C (100 mg / kg) plus fish gelatin hydrolysate (200 mg / kg), and the control and model groups were given an equal amount of normal saline. Intervention continued for 8 weeks.

[0084] d. Detection indicators: Appearance observation: hair gloss and skin wrinkle degree score; skin histology: HE staining, dermal thickness, collagen fiber structure; serum biochemical indicators: SOD, MDA, and GSH-Px levels; inflammatory factor detection: IL-6 and TNF-α levels; 16S rRNA sequencing analysis of intestinal flora; liver tissue pathology observation and CYP450 expression analysis.

[0085] 3. Experimental results:

[0086] 3.1 The Chinese herbal composition significantly improved skin appearance

[0087] Observation of the skin conditions of the experimental rats in each group revealed that the model group exhibited significant signs of skin aging compared to the blank control group, including sagging, deeper wrinkles, decreased elasticity, and slowed hair regeneration. In contrast, the skin conditions of the three groups of rats treated with the traditional Chinese medicine composition improved compared to the model group, with reduced wrinkles, smoother and firmer skin, reduced sagging, and accelerated hair regeneration. The improvement was most significant in the high-dose group, suggesting that the traditional Chinese medicine composition of the present invention exhibits a dose-dependent anti-skin aging effect.

[0088] 3.2 Chinese herbal medicine combination significantly improves skin aging

[0089] Skin elasticity, an important indicator of skin mechanical properties, is significantly negatively correlated with the number of wrinkles, indirectly reflecting the degree of skin aging. Elasticity analysis was performed using an FC1502 skin analyzer, and wrinkle depth was analyzed using a three-dimensional skin profilometer. The experimental results (Table 1) showed that the skin elasticity of the model rats was significantly decreased compared to the blank control group, indicating severe skin aging. However, after intervention with the Chinese herbal composition, skin elasticity was improved to varying degrees in all groups, and wrinkle depth was significantly reduced. The effects were particularly pronounced at medium and high doses, with the high-dose group showing superior effects compared to the positive drug group, with statistically significant differences (P < 0.05). This suggests that the Chinese herbal composition can significantly improve the decline in skin elasticity caused by aging and reduce skin wrinkles.

[0090] Table 1. Skin elasticity and wrinkle depth measurements (n=10, **P<0.01 vs. model group)

[0091]

[0092]

[0093] 3.3 The Chinese herbal medicine composition significantly improved skin tissue morphology

[0094] As shown in Table 2, HE staining showed that the dermis of the skin of rats in the normal control group was intact, with uniform thickness, densely arranged collagen fibers, a large number of fibroblasts and skin appendages, and a good overall structure. In contrast, the skin tissue of the aging model group was significantly damaged, with a significantly thinner dermis, loose structure, a reduced number of appendages, sparse and disordered collagen fibers, and obvious characteristics of skin aging. In the intervention group of the Chinese medicine composition, the skin histological structure gradually improved with increasing doses. The medium-dose and high-dose groups were close to normal levels in terms of dermal thickness, collagen fiber density, and elastic fiber content. In particular, the dermal thickness of the high-dose group recovered to 278.6±8.2μm, and the collagen fiber and elastic fiber areas reached 41.1% and 36.4%, respectively, which were significantly better than those of the model group and the positive control group (P<0.05). Masson staining results further confirmed the recovery of collagen structure, which was better than that of the positive control group. The results showed that the Chinese medicine composition can effectively improve the skin structure of the aging model, significantly increase the content of collagen and elastic fibers, and enhance the density and integrity of skin tissue. Its anti-aging effect has good dose dependence.

[0095] Table 2. The Chinese herbal medicine composition significantly improved skin tissue morphology (n=10, **P<0.01 vs. model group)

[0096]

[0097]

[0098] 3.4 Chinese herbal medicine composition significantly improves skin composition

[0099] Compared with the normal control group, the water content, hydroxyproline (HYP), hyaluronic acid (HA), and collagen content of the skin tissue of the rats in the model group were significantly decreased (P < 0.01), indicating that the aging model was successfully established and the skin structure was damaged. After intervention with the Chinese herbal composition, all skin function indicators were improved, and the improvement trend was dose-dependent. The high-dose group performed best, with all five indicators significantly higher than the model group (P < 0.01) and close to normal levels. The effect was better than the positive control group, indicating that the Chinese herbal composition has good anti-aging and skin repair effects.

[0100] Table 3. The Chinese herbal medicine composition significantly improved skin composition (n=10, **P<0.01 vs. model group)

[0101]

[0102]

[0103] 3.5 Chinese herbal medicine composition significantly reduces oxidative stress and inflammatory response

[0104] Oxidative stress and inflammatory response are the main causes of accelerated skin aging. As shown in Table 4, compared with the normal control group, the SOD activity in the skin tissue of rats in the aging model group was significantly decreased (P < 0.05), and the MDA content and the levels of inflammatory factors IL-6 and TNF-α were significantly increased (P < 0.05). After intervention with the Chinese medicine composition, each dose group was able to effectively increase SOD activity, reduce MDA content, and improve the antioxidant capacity of skin tissue. The levels of inflammatory factors IL-6 and TNF-α were significantly lower than those in the model group, indicating that the Chinese medicine composition can alleviate the inflammatory state of skin tissue. With the increase of dose, the degree of improvement of each indicator increased, among which the high-dose group had the most significant effect, close to the normal level, and significantly better than the positive control group.

[0105] Table 4. Effects of Chinese herbal medicine combination on oxidative stress and inflammatory response in skin tissue (n=10, **P<0.01 vs. model group)

[0106]

[0107]

[0108] 3.5 Chinese herbal medicine combination significantly reduces liver damage in aging models

[0109] Impaired liver function is an important cause of aging. As shown in Table 5, the ALT and AST levels in the livers of aging model rats were significantly increased (P < 0.05), indicating liver cell damage; at the same time, the MDA level increased and the GSH-Px activity decreased, indicating impaired antioxidant capacity; the inflammatory factor IL-6 level was significantly increased, reflecting an enhanced inflammatory state. After intervention with the Chinese medicine composition, the ALT and AST levels of rats in each dose group decreased significantly, and liver function improved; GSH-Px activity increased and MDA decreased, indicating enhanced antioxidant system function; IL-6 levels decreased, indicating that the inflammatory level was alleviated. The higher the dose, the more obvious the improvement effect, with the high-dose group closest to the normal level and significantly better than the positive control group.

[0110] Table 5. Effects of Chinese herbal medicine combination on oxidative stress and inflammatory response in liver tissue (n=10, **P<0.01 vs model group)

[0111]

[0112] 3.6 Effect score of Chinese herbal medicine combination on intestinal tissue repair indicators

[0113] As the largest immune organ in the body, the intestine can protect the integrity of the intestinal barrier, affect the body's immunity, and play an anti-aging role. The cell structure of rat intestinal tissue was observed by transmission electron microscopy, and the results showed (Table 6) that the intestinal epithelial structure was significantly damaged in aging model rats. The large intestinal tissue showed sparse and disordered microvilli, incomplete cell connection structure, autophagy and cytoplasmic organ damage in some cells; the microvilli in the small intestinal tissue were collapsed or missing, the intercellular connections were disordered, the mitochondria were slightly swollen, and the endoplasmic reticulum expanded. After intervention with the Chinese medicine composition, the structure of the large and small intestine tissues was significantly improved, especially in the medium and high dose groups, which showed a better repair effect. The mucosal epithelial cells were arranged regularly, the cell connection structure was restored, the cytoplasmic organ structure was intact, the microvilli were abundant and arranged neatly, and the intestinal barrier structure was close to normal levels. However, the positive drug was not observed to have a significant protective effect on the ultrastructure of intestinal tissue.

[0114] Table 6. Effects of Chinese herbal medicine combination on intestinal tissue ultrastructure (n=10, **P<0.01 vs model group)

[0115]

[0116] Note: The maximum score for each score is 5 points, and the higher the score, the closer the structure is to normal; Scoring criteria: 1. Microvilli integrity score: a comprehensive evaluation based on microvilli density, length, and arrangement; 2. Cell connection score: a score based on the integrity of tight junctions, desmosomes, and adnexa; 3. Small intestinal microvilli arrangement score: mainly based on the direction and consistency of microvilli arrangement; 4. Cytoplasmic organ structure score: a comprehensive score based on mitochondrial swelling, vacuoles, and endoplasmic reticulum expansion.

[0117] 3.7 Regulatory effects of Chinese herbal medicine compositions on intestinal flora

[0118] 16S rRNA gene sequencing revealed (Table 7) that, at the phylum level, the abundance of Bacteroidota increased significantly, while that of Firmicutes decreased significantly in the aging model group, and the F / B ratio (Firmicutes / Bacteroidota) decreased from 1.48 to 0.48 (P<0.05). After intervention with the Chinese herbal medicine composition, the abundance of Bacteroidota decreased to 42.3%, while that of Firmicutes recovered to 46.8%, and the F / B ratio rebounded to 1.11 (P<0.05). At the genus level, the proinflammatory genera Muribaculaceae and Alloprevotella increased by 98% and 157%, respectively, after aging, but decreased by 34% and 43%, respectively, after intervention with the TCM composition (P < 0.05). The beneficial bacterial genus Lachnospiraceae_NK4A136_group (producing short-chain fatty acids) decreased by 67% after aging, but recovered to 14.5% after intervention with the TCM composition (P < 0.05). This suggests that the TCM composition can reshape the microbial community structure, significantly reversing the imbalance in the F / B ratio caused by aging, inhibiting the proinflammatory genera (Muribaculaceae and Alloprevotella), promoting the proliferation of butyrate-producing bacteria (Lachnospiraceae), and restoring the ecological balance of the microbial community.

[0119] Table 7. Effects of Chinese herbal medicine combination on intestinal flora (n=6, data are relative abundance, **P<0.01 vs model group)

[0120]

[0121] 3.8 Chinese herbal medicine compositions regulate aging-related indicators by remodeling intestinal flora

[0122] To further elucidate the relationship between changes in the intestinal microbiota and aging, Pearson correlation coefficients were calculated using statistical methods (Table 8). Lachnospiraceae showed a significant positive correlation with HYP content (r = 0.82, P < 0.001). This genus metabolizes butyrate, which activates the PPAR-γ pathway in skin fibroblasts and promotes collagen gene expression. It also showed a significant negative correlation with IL-6 (r = -0.76, P < 0.001). Butyrate inhibits macrophage NLRP3 inflammasome activation and reduces IL-6 secretion. Muribaculaceae was positively correlated with MDA (r = 0.65, P = 0.004). Enrichment of this genus leads to increased intestinal permeability, lipopolysaccharide (LPS) entry into the blood, activates NADPH oxidase, and induces skin lipid peroxidation. Lactobacillus was positively correlated with the activity of the antioxidant enzyme SOD (r = 0.73, P = 0.001). Lactobacillus metabolites (such as lactic acid) upregulated the skin Nrf2 pathway and enhanced antioxidant enzyme expression. The F / B ratio was negatively correlated with the R² value of skin elasticity (r = -0.81, P < 0.001). A Firmicutes-dominated microbiome may maintain intestinal tight junctions, reduce endotoxin translocation, and indirectly protect the dermal matrix. Results showed strong correlations between key microbial markers and aging indicators (|r| > 0.7, P < 0.001). The microbial regulatory effect (Lachnospiraceae abundance increased) in the TCM combination group was significantly positively correlated with skin HYP content (r = 0.82) and elasticity recovery (r = 0.79), supporting a "microbiome-liver-skin" axis regulatory mechanism.

[0123] Table 8. Correlation analysis between microbial flora and aging indicators (Pearson correlation coefficient)

[0124]

[0125] Example 7 (Clinical trial to evaluate the beauty and anti-aging effects of this Chinese medicine composition)

[0126] 1. Purpose of the test:

[0127] To evaluate the safety and effectiveness of this compound in improving skin quality, enhancing energy metabolism, and regulating mood in subhealthy women.

[0128] 2. Experimental methods:

[0129] Trial design: Randomized, double-blind, placebo-controlled, parallel-controlled clinical trial.

[0130] Participants: 90 female volunteers aged 25 to 55 years with any of the following characteristics: dry skin, dark spots, insufficient Qi and blood, constipation, and fatigue. They were randomly divided into a Chinese herbal combination group (1g daily of freeze-dried powder of the Chinese herbal combination); a placebo group (base powder with the same appearance and taste); and a positive control group (collagen peptide + vitamin C drink).

[0131] Trial period: 8 weeks of continuous use, 4 weeks of follow-up observation period.

[0132] 2. Evaluation indicators:

[0133] Skin elasticity and hydration (Corneometer, Cutometer); facial wrinkle and pigmentation scores (VISIA imaging analysis); serum antioxidant markers (SOD, MDA, GSH-Px); intestinal microecological analysis (fecal 16S rRNA sequencing); Traditional Chinese Medicine syndrome scores (Qi and blood deficiency, liver depression, spleen deficiency) and subjective questionnaire (SF-36 health questionnaire).

[0134] 3. Result analysis:

[0135] 3.1 Main Observation Indicators and Results

[0136] Table 9. The therapeutic effects of the Chinese medicine composition were evaluated from multiple perspectives, including skin elasticity, VISIA analysis, biochemical indices, intestinal flora, and hepato-renal toxicity. The results are as follows:

[0137] a. Skin improvement: The skin elasticity of the Chinese medicine combination group (R2=0.72) was significantly better than that of the positive control group (0.65, P<0.05) and the placebo group (0.58, P<0.01), and the area of ​​pigmentation was reduced by 42.5% (vs the placebo group).

[0138] b. VISIA analysis showed that wrinkle density in the Chinese medicine group decreased by 33.2% (vs baseline), an effect 1.56 times that of the positive control group (21.3%).

[0139] c. Antioxidation and metabolism: The serum SOD activity of the Chinese medicine group increased by 37.2%, and the MDA level decreased by 35.6%, which was significantly better than the positive control group (SOD increased by 16.8%, and MDA decreased by 20.3%).

[0140] d. The serum IL-6, TNF-α and CRP levels in the TCM group were significantly lower than those in the placebo group (P<0.001), and were better than those in the positive control group.

[0141] e. The Shannon index of intestinal flora increased by 26.8% (vs the placebo group), and the abundance of Akkermansia increased by 2.1 times (P < 0.01).

[0142] f. Improvement in Traditional Chinese Medicine (TCM) symptoms: Qi and blood deficiency scores decreased by 41.9% (P < 0.001), while liver depression and spleen deficiency scores decreased by 34.2% and 38.6%, respectively (P < 0.01). The SF-36 health questionnaire showed that the energy dimension score increased by 52.4% in the TCM group (vs 28.1% in the placebo group, P < 0.01).

[0143] g. Safety: There were no abnormal fluctuations in liver and kidney function indicators (ALT, Cr), and the incidence of adverse events (6.7%) was not statistically different from that in the placebo group (6.5%) and the active group (10.0%) (P>0.05).

[0144] Table 9. Effects of Chinese medicine on various indicators (data are mean ± standard deviation)

[0145]

[0146]

[0147] Note: Data are mean ± standard deviation, * and ** indicate P < 0.05, P < 0.01 compared with the placebo group; # indicates P < 0.05 compared with the positive control group;

[0148] 3.2 Correlation analysis results

[0149] The results, as shown in Table 10, showed a strong negative correlation between the inflammatory marker IL-6 and skin elasticity, a positive correlation between TNF-α and wrinkle density (r = 0.68), and a significant correlation between CRP and spot area (r = 0.65). Microbial diversity (Shannon index) was negatively correlated with both IL-6 (r = -0.69) and TNF-α (r = -0.64). SOD activity was strongly negatively correlated with MDA (r = -0.82). The Qi and Blood Deficiency score was negatively correlated with SOD activity (r = -0.66), suggesting that "tonifying Qi and nourishing Blood" can be achieved through enhancing antioxidant capacity. The microbial Shannon index was positively correlated with skin hydration (r = 0.70), validating the Traditional Chinese Medicine (TCM) theory that "the spleen governs transportation and transformation, and its manifestation is manifested in the four white parts of the lips." In summary, this confirms the pivotal role of the "gut-liver-skin axis" in aging. This compound, through the triple mechanisms of microbial remodeling, redox balance, and holistic TCM conditioning, achieves multidimensional anti-aging from the molecular to the systemic level, transcending the limitations of traditional single-ingredient preparations.

[0150] Table 10. Correlation analysis of main observation indicators (Pearson correlation coefficient)

[0151]

[0152]

[0153] In summary, the present Chinese medicine formula, by regulating the body's "microbiome-metabolism-immunity" tri-axis, repairs the "gut-liver-skin" axis caused by aging, corrects Qi and blood deficiency, liver depression, and spleen deficiency, and achieves both "skin" and "root" treatments. This multi-dimensional combination of "moistening the lungs, replenishing essence, clearing the liver, and activating blood circulation" demonstrates clear anti-aging and metabolic regulation potential, and no identical patent combination has been found.

[0154] The above descriptions are merely embodiments of the present invention and are not intended to limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made using the contents of the present invention description and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging, characterized in that: The following ingredients are included by weight percentage: Pear 15%-25%, fish glue 10%-15%, wheat grass 8%-12%, wolfberry 8%-12%, polygonatum 6%-10%, salvia miltiorrhiza 5%-10%, poria 5%-8%, yam 4%-8%, rose 2%-5%.

2. A Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to claim 1 and a preparation method thereof, characterized in that: The dosage form of the composition includes granules, capsules, freeze-dried powder, functional beauty drinks or tablets.

3. A method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to any one of claims 1 to 2, characterized in that: The following steps are involved: S1. Raw material pretreatment: beating pears, soaking and chopping fish glue, and coarse powdering of other medicinal materials; S2, decoction extraction: decoct the medicinal materials except fish glue with water; S3, dissolve the fish glue and mix; S4, concentration and drying: vacuum concentration, spray drying; S5. Preparation molding: Different dosage forms can be made according to needs.

4. The method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to claim 3, characterized in that: The S2 step requires the use of a boiling device, which includes a tank body, a feed port fixedly installed on the top of the tank body, a top cover threadedly connected to the top of the outer side of the feed port, a cloth bag fixedly installed on the top of the inner side of the tank body, a lifting motor fixedly installed on the back of the tank body, a threaded rod fixedly installed on the output end of the lifting motor, a threaded sleeve threadedly connected to the outer side of the threaded rod, a connecting plate fixedly installed on the top of the threaded sleeve, sliding rods fixedly installed at both ends of the bottom of the connecting plate, extrusion plates fixedly installed at the bottom of the two sliding rods, and a heating component fixedly installed inside the tank body.

5. The method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to claim 4, characterized in that: The cloth bag is arranged at the bottom of the feed port, and the bottom of the cloth bag is arranged at the top of the extrusion plate.

6. The method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to claim 5, characterized in that: The two sliding rods are both slidably connected to the inside of the top of the tank body.

7. The method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to claim 4, characterized in that: A stirring motor is fixedly mounted on the bottom of the tank body, a rotating shaft is fixedly mounted on the output end of the stirring motor, and a plurality of stirring blades are fixedly mounted on the outer side surface of the rotating shaft.

8. The method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to claim 7, characterized in that: The plurality of stirring blades are all arranged on the inner side of the tank body and located at the bottom of the extrusion plate.

9. The method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to claim 4, characterized in that: A water outlet valve is fixedly installed on the bottom of the front side of the tank body.

10. The method for preparing a traditional Chinese medicine composition for regulating the gut-liver-skin axis and alleviating aging according to claim 9, characterized in that: Support frames are fixedly installed around the bottom of the tank body.

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