A composition for conditioning the spleen and liver and its use

Abstract

The application belongs to the technical field of traditional Chinese medicine composition preparation, and particularly relates to a composition for regulating spleen and liver and application thereof. The application takes 'dispersing liver and invigorating spleen' as the core of traditional Chinese medicine theory, combines modern 'gut flora-liver axis' and 'nutrition antioxidant theory', and carries out systematic regulation through food medicine homologous food, probiotics and fermented food (enzyme) in multiple ways and multiple targets. In the composition, Morinda officinalis (Noni), mulberry and black medlar are monarch drugs, which play the functions of tonifying liver and kidney and nourishing blood and softening liver; Poria cocos, yiyi, yam, lotus seed, amomum villosum, dried tangerine or orange peel, dried ginger and black pepper are minister drugs, which invigorate spleen and replenish qi, remove dampness and harmonize the center; hawthorn, malt, radix puerariae, dandelion, honeysuckle and chrysanthemum are auxiliary drugs, which can digest and remove stagnation and clear heat; through'monarch-minister-auxiliary' combination, synergistic effect is achieved, liver and spleen are regulated, and the theory of 'Huangdi Neijing' and 'Huangdi Mi Jing' is met.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition preparation technology, specifically relating to a composition for regulating the spleen and liver and its application. Background Technology

[0002] In modern life, due to factors such as staying up late, irregular eating habits, excessive stress, and environmental pollution, liver and spleen imbalances (such as fatty liver, indigestion, and weakened immunity) are becoming increasingly common. Traditional Chinese medicine emphasizes the principle of "harmonizing the liver and spleen." For example, the *Suwen* (Plain Questions) chapter "On the Taiyin and Yangming" states that "the spleen and stomach are connected by a membrane, and the spleen can regulate the body fluids," indicating that they are closely linked in structure and function, meaning the spleen and stomach are internally and externally related: the spleen and stomach reside in the middle jiao (middle burner) and are interconnected through meridians, forming an internal-external relationship, physiologically connected and pathologically influencing each other. The *Suwen* chapter "On Preserving Life and Completing the Form" mentions that "wood is felled by metal, fire is extinguished by water, and earth is nourished by wood," with "earth being nourished by wood" reflecting the liver's role in regulating the spleen's function. The liver governs the free flow of Qi and regulates its circulation, aiding in the digestive function of the spleen and stomach. A healthy spleen, with sufficient Qi and blood, nourishes the liver. Most importantly, a strong spleen is a key to anti-aging. The *Suwen* (Plain Questions) states, "The kidney is the gate of the stomach; if the gate is not functioning properly, water will accumulate and follow its kind," indicating that the kidney governs water. Sufficient kidney Qi effectively controls the metabolism of fluids in the spleen and stomach. This means the kidney is the foundation of innate constitution, while the spleen is the foundation of acquired constitution. The spleen's digestive function depends on the warming effect of kidney Yang, and the essence of the kidney relies on the continuous replenishment of the essence of food and water transformed by the spleen. Therefore, the harmonious regulation of the liver and spleen is crucial.

[0003] However, existing technologies mostly provide single-target products for liver protection or spleen strengthening. For example, Chinese patent CN 103549081A uses a combination of acacia leaves, dog's tooth flower, monk fruit, verbena, wild chrysanthemum, and ganoderma, which has the effects of promoting blood circulation, clearing heat, and protecting the liver. Another example is Chinese patent CN 103157065A, which uses a mixture of codonopsis, astragalus, costus root, trogopterus dung, luffa fruit, hedgehog skin, citronella, bupleurum, gardenia, cuttlebone, turmeric, fritillaria, galangal, and atractylodes macrocephala to strengthen the spleen and nourish the stomach. Therefore, if a composition for regulating the spleen and liver could be provided, it would be beneficial to provide multi-target products in this field and reduce the suffering of patients who have to take multiple medications. Summary of the Invention

[0004] The purpose of this invention is to provide a composition for regulating the spleen and liver and its application. The composition is easy to prepare and can protect the liver and strengthen the spleen simultaneously.

[0005] This invention provides a composition for regulating the spleen and liver, the composition comprising: core traditional Chinese medicine, prebiotics, polypeptide complex and flavoring complex; The mass ratio of the core Chinese herbal medicine, prebiotics, polypeptide complex, and flavoring complex is 100:0.5-1:0.5-1:2-7; The core Chinese medicinal herbs include: Morinda officinalis, mulberry, black goji berry, Poria cocos, coix seed, yam, lotus seed, hawthorn, malt, tangerine peel, dandelion, honeysuckle, chrysanthemum, kudzu root, dried ginger, black pepper, and amomum villosum; The prebiotics include: inulin; The polypeptide complex includes: corn peptide, pea peptide, and hemp seed peptide; The flavoring compound includes: blueberry, prickly pear, grape and acerola cherry.

[0006] Preferably, the core traditional Chinese medicine comprises, by weight parts: 40-50 parts of Morinda officinalis, 10-15 parts of mulberry, 4-8 parts of black goji berries, 8-12 parts of Poria cocos, 15-20 parts of coix seed, 20-25 parts of yam, 5-10 parts of lotus seed, 10-20 parts of hawthorn, 10-15 parts of malt, 4-10 parts of dried tangerine peel, 5-10 parts of dandelion, 10-15 parts of honeysuckle, 4-8 parts of chrysanthemum, 10-20 parts of kudzu root, 5-10 parts of dried ginger, 0.5-2 parts of black pepper, and 1-5 parts of amomum villosum. In the polypeptide complex, the mass ratio of corn peptide, pea peptide and hemp seed peptide is 1:1-2:1-2; In the flavoring compound, the mass ratio of blueberry, prickly pear, grape and acerola cherry is 2-3:2-3:1:1.

[0007] The present invention provides a method for preparing the composition described in the above technical solution, comprising the following steps: S1. Freeze, dry at low temperature and pulverize fresh sea morinda fruit to obtain sea morinda powder; mix sea morinda powder, compound enzyme and water for enzymatic hydrolysis to obtain sea morinda hydrolysate; anaerobic ferment the sea morinda hydrolysate to obtain sea morinda fermentation stock solution; the compound enzyme includes: cellulase and pectinase; S2. Mix mulberry, black goji berry, poria cocos, coix seed, yam, lotus seed, hawthorn, malt, dried tangerine peel, dandelion, honeysuckle, chrysanthemum, kudzu root, dried ginger, black pepper, and cardamom, then grind them into powder to obtain Chinese herbal medicine powder; mix the Chinese herbal medicine powder, Bacillus subtilis, brown sugar, and water for aerobic fermentation to obtain aerobic fermentation liquid; S3. Combine the Morinda officinalis fermentation broth and the aerobic fermentation broth to obtain a mixed broth; mix the mixed broth, prebiotics and compound probiotics and carry out anaerobic chelation fermentation to obtain a chelated fermentation broth; S4. The chelated fermentation broth, polypeptide complex and flavoring complex are mixed and then subjected to low-temperature alcoholization and filtration to obtain the composition.

[0008] Preferably, in step S1, the freezing temperature is 0-4℃ and the freezing time is 20-24h; Low-temperature drying at 45-55℃ yields Morinda officinalis with a moisture content of ≤8%.

[0009] Preferably, in step S1, during enzymatic hydrolysis, the mass ratio of Morinda officinalis powder, compound enzyme, and water is 15-20:0.5-1:80-85. The enzymatic hydrolysis is performed at a temperature of 45-60℃ for 10-15 hours. In the complex enzyme, the mass ratio of cellulase to pectinase is 1:0.03-0.1.

[0010] Preferably, in step S1, anaerobic fermentation is carried out in a closed environment at a temperature of 25-35°C for a duration of 6-18 months.

[0011] Preferably, in step S2, during aerobic fermentation, the mass ratio of the Chinese herbal medicine powder, Bacillus subtilis, brown sugar, and water is 10-15:0.2-0.5:1-3:85-90. The aerobic fermentation is carried out at a temperature of 38-42℃ for 24-36 hours. The effective viable count of Bacillus subtilis is ≥1×10⁻⁶. 7 cfu / g.

[0012] Preferably, in step S3, when using Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, and Bifidobacterium lactis as a compound probiotic for anaerobic chelation fermentation, the mass ratio of the mixture to the compound probiotic is 100:0.3-0.5. In the compound probiotics, the mass ratio of Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, and Bifidobacterium lactis is 1:1.5-2:1:1; The effective viable counts of *Lactobacillus plantarum*, *Lactobacillus rhamnosus*, *Lactobacillus casei*, and *Bifidobacterium lactis* were ≥1×10⁻⁶. 7 cfu / g; The anaerobic chelation fermentation was carried out at a temperature of 38-42℃ for 36-144 hours.

[0013] Preferably, in step S3, when using Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium lactis, Saccharomyces cerevisiae, and Rhizopus oryzae as compound probiotics for anaerobic chelation fermentation, the mass ratio of the mixture to the compound probiotics is 100:0.3-0.5. The mass ratio of Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium lactis, Saccharomyces cerevisiae, and Rhizopus oryzae in the compound probiotics is 1:1.5-2:1:1:1:0.5-1. The effective viable counts of *Lactobacillus plantarum*, *Lactobacillus rhamnosus*, *Lactobacillus casei*, *Bifidobacterium lactis*, *Saccharomyces cerevisiae*, and *Rhizopus oryzae* were ≥1×10⁻⁶. 7 cfu / g; The anaerobic chelation fermentation was carried out at a temperature of 32-37℃ for 72 hours.

[0014] This invention provides the application of the composition described above in the preparation of products for regulating the spleen and liver.

[0015] Beneficial effects: This invention provides a composition for regulating the spleen and liver, the composition comprising: core traditional Chinese medicine, prebiotics, polypeptide complex, and flavoring complex; the mass ratio of the core traditional Chinese medicine, prebiotics, polypeptide complex, and flavoring complex is 100:0.5-1:0.5-1:2-7; the core traditional Chinese medicine includes: Morinda officinalis, mulberry, black goji berry, Poria cocos, coix seed, yam, lotus seed, hawthorn, malt, tangerine peel, dandelion, honeysuckle, chrysanthemum, kudzu root, dried ginger, black pepper, and amomum villosum; the prebiotics include: inulin; the polypeptide complex includes: corn peptide, pea peptide, and hemp seed peptide; the flavoring complex includes: blueberry, prickly pear, grape, and acerola cherry.

[0016] This invention takes "soothing the liver and strengthening the spleen" as the core of traditional Chinese medicine theory, combined with modern "gut flora-liver axis" and "nutritional antioxidant theory," to systematically regulate the body through multiple pathways and targets using food-medicine homologous foods, probiotics, and fermented foods (enzymes). Among them, Morinda officinalis (Noni), mulberry, and black goji berries are the principal herbs, exerting the effects of tonifying the liver and kidneys, nourishing blood, and softening the liver; Poria cocos, coix seed, yam, lotus seed, amomum villosum, tangerine peel, dried ginger, and black pepper are the assistant herbs, strengthening the spleen and replenishing qi, dispelling dampness and harmonizing the middle jiao; hawthorn, malt, kudzu root, dandelion, honeysuckle, and chrysanthemum are the adjuvant herbs, able to promote digestion, relieve stagnation, and clear heat; through the "principal-assistant-adjuvant-adjuvant" combination, synergistic effects are achieved, realizing the simultaneous regulation of the liver and spleen, in accordance with the theories of the *Huangdi Neijing* and *Nanjing*.

[0017] Furthermore, the fermentation method of this invention helps to degrade macromolecular substances in raw materials, remove toxins from food, and improve the absorption rate of active ingredients (such as puerarin and anthocyanins), resulting in high bioavailability. At the same time, this invention relies on the antibacterial and preservative properties of Noni fermented food itself, as well as the antibacterial effects of honeysuckle, dandelion, and black pepper. Relying on the inherent characteristics of the plants themselves, there is no need to add chemical preservatives, resulting in high safety and strong stability. Detailed Implementation

[0018] In this invention, unless otherwise specified, the raw materials, equipment and methods used are all conventional selections.

[0019] The raw materials used in this invention are described below: Morinda officinalis, scientific name: Morinda citrifolia L. (Rubiaceae family, Morinda genus), mature fruit; Mulberry, scientific name: White mulberry L. (Moraceae family, Morus genus), refers to dried fruit spikes; Black goji berry, scientific name: Lycium ruthenium Murr. (Solanaceae family, Lycium genus), the ripe fruit; Poria cocos, scientific name: Poria cocos (Schw.) Wolf (a fungus of the Polyporaceae family), the dried sclerotium; Job's tears, scientific name: Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf (Poaceae family, Coix genus), dried mature seeds.

[0020] Yam, scientific name: Dioscorea opposita Thunb. (Dioscoreaceae family, Dioscorea genus), dried rhizome (tuber); Lotus seed, scientific name: Water lily Gaertn. (Nelumbo nucifera, family Nymphaeaceae), refers to the dried, mature seeds; hawthorn, scientific name: Hawthorn pinnatifida Bge. (Rosaceae family, Crataegus genus), dried, ripe fruit; Malt, scientific name: Barley L. (Poaceae) Germinated caryopsis of barley; Dried tangerine peel, scientific name: Citrus reticulata The dried, mature peel of Blanco mandarin (Citrus genus, Rutaceae family); Dandelion, scientific name: Mongolian dandelion Hand.-Mazz. (Taraxacum genus, Asteraceae family), the whole plant is usable; Honeysuckle, scientific name: Japanese honeysuckle Thunb. (Caprifoliaceae family, Lonicera genus), refers to dried flower buds or newly opened flowers; Chrysanthemum, scientific name: Chrysanthemum morifolium Ramat. (Asteraceae family, Chrysanthemum genus), capitula (dried flowers); Kudzu root, scientific name: Lobed Pueraria (Willd.) Ohwi (Fabaceae family, Pueraria genus) dried root of wild kudzu; Dried ginger, scientific name: Ginger officinalis Rosc. (Zingiberaceae family, Zingiber genus), dried rhizome; Black pepper, scientific name: Black pepper L. (Piperaceae family, Piper genus), refers to the dried, nearly mature fruit; Amomum villosum, scientific name: Woolly amaranth Lour. Dried, ripe fruit of Amomum villosum; Blueberry, scientific name: Blueberry L. In a specific embodiment, fresh fruit is selected; prickly pear, scientific name: Rose of Roxburgh Tratt. In a specific embodiment, fresh fruit is selected; Grape, scientific name: Wine grapevine L. In a specific embodiment, fresh fruit is selected; Acerola cherry, scientific name: Malpighia emarginata DC. In a specific embodiment, fresh fruit is selected.

[0021] Corn peptides, pea peptides, and hemp seed peptides are purchased regularly.

[0022] To further illustrate the present invention, the solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0023] Example 1 The steps for preparing a composition for regulating the spleen and liver are as follows: (1) The composition used to regulate the spleen and liver includes: core Chinese medicine, prebiotics (microbial powder), polypeptide complex and flavoring complex; By weight, the core Chinese medicinal herbs include the following ingredients: 50 parts of Morinda officinalis, 10 parts of mulberry, 6 parts of black goji berries, 12 parts of Poria cocos, 20 parts of coix seed, 20 parts of yam, 10 parts of lotus seed, 10 parts of hawthorn, 10 parts of malt, 6 parts of dried tangerine peel, 10 parts of dandelion, 10 parts of honeysuckle, 6 parts of chrysanthemum, 10 parts of kudzu root, 5 parts of dried ginger, 2 parts of black pepper, and 5 parts of amomum villosum. Corn peptides, pea peptides, and hemp seed peptides were mixed in a mass ratio of 1:2:2 to obtain a polypeptide complex. Blueberries, prickly pears, grapes, and acerola cherries were mixed in a mass ratio of 2:2:1:1 to obtain a flavoring compound. The mass ratio of the core Chinese herbal medicine, prebiotics, polypeptide complex and flavoring complex is 100:1:1:7; (2) Preparation of Morinda officinalis fermentation broth Clean and dry the above-mentioned raw materials separately before use; The fruits of *Morinda officinalis* were frozen at 4℃ for 24 hours, and then dried at 45℃ until the moisture content of the *Morinda officinalis* was 8%. The dried *Morinda officinalis* was then pulverized to obtain pulverized material (particle size ≤ 0.1 cm). The pulverized material, a compound enzyme (composed of cellulase and pectinase in a mass ratio of 1:0.1), and water were mixed evenly at a mass ratio of 15:1:85 and enzymatically hydrolyzed at 51℃ for 10 hours. After enzyme inactivation, the enzymatic hydrolysate was obtained. The enzymatic hydrolysate was then placed in a sealed environment and anaerobically fermented at 25℃ for 12 months to obtain the *Morinda officinalis* fermentation stock solution. (3) Preparation of mixed fermentation broth Mulberry, black goji berries, poria cocos, coix seed, yam, lotus seed, hawthorn, malt, dried tangerine peel, dandelion, honeysuckle, chrysanthemum, kudzu root, dried ginger, black pepper, and cardamom are mixed and pulverized to obtain a mixture (particle size ≤ 0.1 cm); the mixture, Bacillus subtilis ( Bacillus subtilis The effective viable bacteria count is 1×10⁻⁶. 8After mixing CFU / g, brown sugar and water in a mass ratio of 10:0.5:3:90, the mixture was fermented aerobically at 42℃ for 24 hours to obtain an aerobic fermentation liquid. (4) Preparation of the composition After combining the above-mentioned Morinda officinalis fermentation broth and aerobic fermentation broth, a mixed liquid is obtained; this mixed liquid is then mixed with a compound lactic acid bacteria (composed of Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, and Bifidobacterium lactis in a mass ratio of 1:1.5:1:1; Lactobacillus casei...) Lactobacillus casei Lactobacillus rhamnosus Lactobacillus rhamnosus, Bifidobacterium lactis Bifidobacterium lactis Lactobacillus plantarum Lactobacillus plantarum The effective viable bacteria count was 1×10 8 The mixtures (cfu / g) were mixed at a mass ratio of 100:0.5 and anaerobic chelation fermented at 42℃ for 144 h to obtain the chelated fermentation broth. The chelated fermentation broth, polypeptide complex, and flavoring complex were mixed and aged for 7 days in a cool, dark, and slightly anaerobic environment at 25°C. After filtration, the composition was obtained.

[0024] Example 2 The steps for preparing a composition for regulating the spleen and liver are as follows: The only difference from Example 1 is that step (4) in Example 2 is as follows: After combining the above-mentioned Morinda officinalis fermentation broth and aerobic fermentation broth, a mixed liquid is obtained; this mixed liquid is then mixed with a compound lactic acid bacteria (composed of Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium lactis, Saccharomyces cerevisiae, and Rhizopus oryzae in a mass ratio of 1:1.5:1:1:1:0.5; Lactobacillus casei...). Lactobacillus casei Lactobacillus rhamnosus Lacticoseibacillus rhamnosus Bifidobacterium lactis Bifidobacterium lactis Lactobacillus plantarum Lactobacillus plantarum, brewing yeast Saccharomyces cerevisiae, and Rhizopus Rhizopus rice The effective viable bacteria count was 1×10 8 The mixtures (cfu / g) were mixed at a mass ratio of 100:0.5 and anaerobic chelation fermented at 35℃ for 72 h to obtain the chelated fermentation broth. The chelated fermentation broth, polypeptide complex, and flavoring complex were mixed and aged for 15 days in a cool, dark, and slightly anaerobic environment at 25°C. After filtration, the composition was obtained.

[0025] Comparative Example 1 The steps for preparing a composition for regulating the spleen and liver are as follows: The only difference from Example 1 is that step (1) in Comparative Example 1 is as follows: By weight, the core Chinese medicinal herbs include the following ingredients: 70 parts Morinda officinalis, 2 parts mulberry, 6 parts black goji berries, 12 parts Poria cocos, 20 parts coix seed, 20 parts yam, 10 parts lotus seed, 10 parts hawthorn, 10 parts malt, 6 parts dried tangerine peel, 10 parts dandelion, 10 parts honeysuckle, 6 parts chrysanthemum, 10 parts kudzu root, 30 parts dried ginger, 0.1 parts black pepper, and 5 parts Amomum villosum.

[0026] Comparative Example 2 The steps for preparing a composition for regulating the spleen and liver are as follows: (1) The composition used to regulate the spleen and liver includes: core Chinese medicine, prebiotics (microbial powder), polypeptide complex and flavoring complex; By weight, the core Chinese medicinal herbs include the following ingredients: 50 parts of Morinda officinalis, 10 parts of mulberry, 6 parts of black goji berries, 12 parts of Poria cocos, 20 parts of coix seed, 20 parts of yam, 10 parts of lotus seed, 10 parts of hawthorn, 10 parts of malt, 6 parts of dried tangerine peel, 10 parts of dandelion, 10 parts of honeysuckle, 6 parts of chrysanthemum, 10 parts of kudzu root, 5 parts of dried ginger, 2 parts of black pepper, and 5 parts of amomum villosum. Corn peptides, pea peptides, and hemp seed peptides were mixed in a mass ratio of 1:2:2 to obtain a polypeptide complex. Blueberries, prickly pears, grapes, and acerola cherries were mixed in a mass ratio of 2:2:1:1 to obtain a flavoring compound. The mass ratio of the core Chinese herbal medicine, prebiotics, polypeptide complex and flavoring complex is 100:1:1:7; (2) Preparation of the composition The following ingredients were mixed and pulverized: Morinda officinalis, mulberry, black goji berry, Poria cocos, coix seed, yam, lotus seed, hawthorn, malt, dried tangerine peel, dandelion, honeysuckle, chrysanthemum, kudzu root, dried ginger, black pepper, and cardamom, to obtain a mixture (particle size ≤ 0.1 cm); Bacillus subtilis (…) Bacillus subtilis The effective viable bacteria count is 1×10⁻⁶. 8 The mixture of CFU / g, brown sugar, and water in a mass ratio of 10:0.5:3:90 was fermented aerobically at 42℃ for 24 hours to obtain a mixed fermentation liquid. The mixed fermentation liquid, inulin, polypeptide complex, and flavoring complex were then mixed and aged in a cool, dark, and slightly anaerobic environment at 25℃ for 15 days. After filtration, the final product was obtained.

[0027] Comparative Example 3 The steps for preparing a composition for regulating the spleen and liver are as follows: The only difference from Example 1 is that steps (2)-(4) in Comparative Example 3 are as follows: (2) Preparation of enzyme hydrolysate The fruits of *Morinda officinalis* were frozen at 4℃ for 24 hours, and then dried at 45℃ until the moisture content of *Morinda officinalis* was 8%. The dried *Morinda officinalis* was then pulverized to obtain pulverized material (particle size ≤ 0.1 cm). The pulverized material, a compound enzyme (composed of cellulase and pectinase in a mass ratio of 1:0.1), and water were mixed evenly in a mass ratio of 15:1:85 and enzymatically hydrolyzed at 51℃ for 10 hours. After enzyme inactivation, the enzymatic hydrolysate was obtained. (3) Preparation of mixed fermentation broth Mulberry, black goji berries, poria cocos, coix seed, yam, lotus seed, hawthorn, malt, dried tangerine peel, dandelion, honeysuckle, chrysanthemum, kudzu root, dried ginger, black pepper, and cardamom are mixed and pulverized to obtain a mixture (particle size ≤ 0.1 cm); the mixture, Bacillus subtilis ( Bacillus subtilis The effective viable bacteria count is 1×10⁻⁶. 8 After mixing CFU / g, brown sugar and water in a mass ratio of 10:0.5:3:90, the mixture was fermented aerobically at 42℃ for 24 hours to obtain an aerobic fermentation liquid. (4) Preparation of the composition After combining the above enzymatic hydrolysate and aerobic fermentation broth, a mixed liquid is obtained; this mixed liquid is then mixed with a compound lactic acid bacteria (composed of *Lactobacillus plantarum*, *Lactobacillus rhamnosus*, *Lactobacillus casei*, and *Bifidobacterium lactis* in a mass ratio of 1:1.5:1:1; *Lactobacillus casei*...). Lactobacillus casei Lactobacillus rhamnosus Lacticoseibacillus rhamnosus Bifidobacterium lactis Bifidobacterium lactis Lactobacillus plantarum Lactobacillus plantarum The effective viable bacteria count was 1×10 8 The mixtures (cfu / g) were mixed at a mass ratio of 100:0.5 and anaerobic chelation fermented at 42℃ for 144 h to obtain the chelated fermentation broth. The chelated fermentation broth, polypeptide complex, and flavoring complex were mixed and aged for 7 days in a cool, dark, and slightly anaerobic environment at 25°C. After filtration, the composition was obtained.

[0028] Comparative Example 4 The steps for preparing a composition for regulating the spleen and liver are as follows: The only difference from Example 1 is that step (1) in Comparative Example 4 is as follows: (1) The composition used to regulate the spleen and liver includes: core Chinese medicine, prebiotics (microbial powder), polypeptide complex and flavoring complex; By weight, the core Chinese medicinal herbs include the following ingredients: 100 parts of Morinda officinalis, 10 parts of mulberry, 6 parts of black goji berries, 12 parts of Poria cocos, 20 parts of coix seed, 20 parts of yam, 10 parts of lotus seed, 10 parts of hawthorn, 10 parts of malt, 6 parts of dried tangerine peel, 10 parts of dandelion, 10 parts of honeysuckle, 6 parts of chrysanthemum, 10 parts of kudzu root, 5 parts of dried ginger, 2 parts of black pepper, and 5 parts of amomum villosum. Corn peptides, pea peptides, and hemp seed peptides were mixed in a mass ratio of 10:2:2 to obtain a polypeptide complex. Blueberries, prickly pears, grapes, and acerola cherries were mixed in a mass ratio of 2:2:1:10 to obtain a flavoring compound. The mass ratio of the core Chinese medicine, prebiotics, polypeptide complex and flavoring complex is 100:1:1:7.

[0029] Comparative Example 5 The steps for preparing a composition for regulating the spleen and liver are as follows: The only difference from Example 1 is that step (2) in Comparative Example 5 is as follows: (2) Preparation of Morinda officinalis fermentation broth Wash the fruit of Morinda officinalis thoroughly, dry it, and set it aside for later use. The dried sea morinda was crushed to obtain a powder (particle size ≤ 0.1 cm); the powder and plant lactic acid bacteria were mixed evenly at a mass ratio of 100:0.1, and then anaerobic fermented in a sealed environment at 25°C for 12 months to obtain the sea morinda fermentation liquid.

[0030] Verification Example 1 Healthy white rats weighing 190-200g were used as experimental animals, with half male and half female rats in each group. The rats were randomly divided into a normal control group, a model control group, a validation group (including Example 1, Example 2, Comparative Examples 1-5), and a calming and soothing control group, with 10 rats in each group.

[0031] All treatment groups were housed in the same environment. During the experiment (6 days), the normal control group and the model group were given an equal volume of physiological saline, while the remaining groups were administered different drugs by gavage to each mouse, as detailed below: Example 1: Gavage administration of the composition prepared in Example 1, with a daily gavage dose of 9 g / kg; Example 2: Gavage administration of the composition prepared in Example 2, with a daily gavage dose of 9 g / kg; Comparative Example 1: The composition prepared in Comparative Example 1 was administered by gavage at a daily dose of 9 g / kg; Comparative Example 2: The composition prepared in Comparative Example 2 was administered by gavage at a daily dose of 9 g / kg; Comparative Example 3: The composition prepared in Comparative Example 3 was administered by gavage at a daily dose of 9 g / kg; Comparative Example 4: The composition prepared in Comparative Example 4 was administered by gavage at a daily dose of 9 g / kg; Comparative Example 5: The composition prepared in Comparative Example 5 was administered by gavage at a daily dose of 9 g / kg; Control group for relieving depression and calming the mind: 9g / kg of relieving depression and calming the mind granules were routinely purchased and administered via gavage. On days 1 and 4 of the experiment, 0.4 mL / 100 g CCl4 was injected into the backs of rats in the model control group, validation group, and anti-depression and calming control group, respectively, to induce liver damage. After day 7 of the experiment, blood was collected from the eyeballs of rats in each group, serum was separated, and ALT content was measured. The results are shown in Table 1.

[0032] Table 1. Effects of different treatments on ALT activity in rats with CCl4-induced liver injury.

[0033] As shown in Table 1, both the example and the sedative-temper group significantly reduced ALT activity in rats with CCl4-induced liver injury. Therefore, the composition prepared in the example has a protective effect against CCl4-induced liver injury.

[0034] Verification Example 2 Several healthy mice weighing 25-30g were selected, both male and female. The mice were randomly divided into a model control group, a validation group (including Example 1, Example 2, Comparative Examples 1-5), and a calming and soothing control group, with 10 rats in each group.

[0035] Mice designated as the model control group were subcutaneously injected with reserpine 0.12 mg / kg (0.15 mL / mouse) daily for 10 consecutive days. Starting from day 4 of the experiment, each mouse was administered physiological saline by gavage (0.5 mL / mouse / day) for 7 days. The results showed that this group of mice exhibited symptoms of spleen deficiency, including decreased appetite, loose stools, sparse abdominal and body fur, lethargy, arched back with reduced movement, cold body, and weight loss. This demonstrates that the reserpine method described above can be used to construct a mouse model of spleen deficiency symptoms.

[0036] Mice in the validation group (including Examples 1, 2, Comparative Examples 1-5) and the antidepressant and calming control group were subcutaneously injected with reserpine 0.12 mg / kg (volume 0.15 mL / mouse) daily for 10 consecutive days. Starting from day 4 of the experiment, each mouse in the antidepressant and calming control group was administered antidepressant and calming granules by gavage at a dose of 9 g / kg daily for 7 consecutive days. Starting from day 4 of the experiment, each mouse in the validation group was administered different treatment combinations by gavage at a dose of 9 g / kg daily for 7 consecutive days.

[0037] Normal control group: Ten healthy mice weighing 25-30g each (both male and female) were used. Each mouse was subcutaneously injected with 0.15mL of sterile water for injection once daily for 10 consecutive days. Starting on day 4, each mouse was administered physiological saline by gavage (0.5mL / day) for 7 days. Results showed that the mice exhibited normal behavior, fur appearance, diet, and feces.

[0038] One hour after the last administration of each group, the body weight of each mouse was measured, and the spleen was weighed separately. The spleen immune organ index (mg / g) was calculated using the formula: spleen weight (mg) ÷ body weight (g). The results are shown in Table 2.

[0039] Table 2. Spleen index of mice under different treatments

[0040] The results in Table 2 show that the composition prepared in the examples and the antidepressant and calming granules are both beneficial to improving the spleen organ index of spleen-deficient mice. It can be seen that the composition prepared in this invention has a good spleen-strengthening effect.

[0041] Verification Example 3 The compositions prepared in Examples 1, 2, 1, and 3 were used as test drugs; Sixty mice weighing 19-21g were used, divided into groups of 10. After fasting for 12 hours with unlimited access to water, the mice in Examples 1, 2, Comparative Examples 1 and 3 were administered the prepared compositions by gavage at a dose of 9g / kg. The antidepressant and sedative control group was administered the same dose of antidepressant and sedative granules by gavage, and the blank group was administered the same dose of physiological saline by gavage. Starting 30 minutes after administration, the activity time of the mice was continuously observed and recorded for 10 minutes. Raising their forelegs and walking were considered active, while crawling motionless was considered quiet. The results are shown in Table 3.

[0042] Table 3 Effects of different treatments on spontaneous activity in mice

[0043] As shown in Table 3, compared with the comparative and blank groups, the composition prepared in this invention is beneficial in inhibiting spontaneous activity in mice. That is, the composition prepared in this invention is beneficial for the recovery of spleen and stomach function, the smooth flow of Qi, and the calming of the mind, thus leading to homeostasis in the mice.

[0044] In summary, this invention takes "soothing the liver and strengthening the spleen" as the core of traditional Chinese medicine theory, combined with modern "gut flora-liver axis" and "nutritional antioxidant theory," to systematically regulate the body through multiple pathways and targets using food-medicine homologous foods, probiotics, and fermented foods (enzymes). Among them, Morinda officinalis (Noni), mulberry, and black goji berries are the principal herbs, exerting the effects of tonifying the liver and kidneys, nourishing blood, and softening the liver; Poria cocos, Coix seed, yam, lotus seed, Amomum villosum, tangerine peel, dried ginger, and black pepper are the assistant herbs, strengthening the spleen and replenishing qi, dispelling dampness and harmonizing the middle jiao; hawthorn, malt, kudzu root, dandelion, honeysuckle, and chrysanthemum are the adjuvant herbs, able to promote digestion, relieve stagnation, and clear heat; through the "principal-assistant-adjuvant-adjuvant" combination, synergistic effects are achieved, realizing the simultaneous regulation of the liver and spleen, which conforms to the theories of the *Huangdi Neijing* and *Nanjing*.

[0045] Furthermore, the fermentation method of this invention helps to degrade macromolecular substances in raw materials, remove toxins from food, and improve the absorption rate of active ingredients (such as puerarin and anthocyanins), resulting in high bioavailability. At the same time, this invention relies on the antibacterial and preservative properties of Noni fermented food itself, as well as the antibacterial effects of honeysuckle, dandelion, and black pepper. Relying on the inherent characteristics of the plants themselves, there is no need to add chemical preservatives, resulting in high safety and strong stability.

[0046] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, and not all embodiments. People can obtain other embodiments based on these embodiments without creative effort, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A composition for regulating the spleen and liver, characterized in that, The composition includes: core traditional Chinese medicine, prebiotics, polypeptide complex and flavoring complex; The mass ratio of the core Chinese herbal medicine, prebiotics, polypeptide complex, and flavoring complex is 100:0.5-1:0.5-1:2-7; The core Chinese medicinal herbs include: Morinda officinalis, mulberry, black goji berry, Poria cocos, coix seed, yam, lotus seed, hawthorn, malt, tangerine peel, dandelion, honeysuckle, chrysanthemum, kudzu root, dried ginger, black pepper, and amomum villosum; The prebiotics include: inulin; The polypeptide complex includes: corn peptide, pea peptide, and hemp seed peptide; The flavoring compound includes: blueberry, prickly pear, grape and acerola cherry.

2. The composition according to claim 1, characterized in that, The core traditional Chinese medicine, by weight, includes: 40-50 parts of Morinda officinalis, 10-15 parts of mulberry, 4-8 parts of black goji berries, 8-12 parts of Poria cocos, 15-20 parts of coix seed, 20-25 parts of yam, 5-10 parts of lotus seed, 10-20 parts of hawthorn, 10-15 parts of malt, 4-10 parts of dried tangerine peel, 5-10 parts of dandelion, 10-15 parts of honeysuckle, 4-8 parts of chrysanthemum, 10-20 parts of kudzu root, 5-10 parts of dried ginger, 0.5-2 parts of black pepper, and 1-5 parts of amomum villosum. In the polypeptide complex, the mass ratio of corn peptide, pea peptide and hemp seed peptide is 1:1-2:1-2; In the flavoring compound, the mass ratio of blueberry, prickly pear, grape and acerola cherry is 2-3:2-3:1:

1.

3. A method for preparing the composition according to claim 1 or 2, characterized in that, Includes the following steps: S1. Freeze, dry at low temperature and pulverize fresh sea morinda fruit to obtain sea morinda powder; mix sea morinda powder, compound enzyme and water for enzymatic hydrolysis to obtain sea morinda hydrolysate; anaerobic ferment the sea morinda hydrolysate to obtain sea morinda fermentation stock solution; the compound enzyme includes: cellulase and pectinase; S2. Mix mulberry, black goji berry, poria cocos, coix seed, yam, lotus seed, hawthorn, malt, dried tangerine peel, dandelion, honeysuckle, chrysanthemum, kudzu root, dried ginger, black pepper, and cardamom, then grind them into powder to obtain Chinese herbal medicine powder; mix the Chinese herbal medicine powder, Bacillus subtilis, brown sugar, and water for aerobic fermentation to obtain aerobic fermentation liquid; S3. Combine the Morinda officinalis fermentation broth and the aerobic fermentation broth to obtain a mixed broth; mix the mixed broth, prebiotics and compound probiotics and carry out anaerobic chelation fermentation to obtain a chelated fermentation broth; S4. The chelated fermentation broth, polypeptide complex and flavoring complex are mixed and then subjected to low-temperature alcoholization and filtration to obtain the composition.

4. The preparation method according to claim 3, characterized in that, In step S1, the freezing temperature is 0-4℃ and the freezing time is 20-24h; Low-temperature drying at 45-55℃ yields Morinda officinalis with a moisture content of ≤8%.

5. The preparation method according to claim 3, characterized in that, In step S1, during enzymatic hydrolysis, the mass ratio of Morinda officinalis powder, compound enzyme, and water is 15-20:0.5-1:80-85. The enzymatic hydrolysis is performed at a temperature of 45-60℃ for 10-15 hours. In the complex enzyme, the mass ratio of cellulase to pectinase is 1:0.03-0.

1.

6. The preparation method according to claim 3, characterized in that, In step S1, anaerobic fermentation is carried out in a closed environment at a temperature of 25-35°C for 6-18 months.

7. The preparation method according to claim 3, characterized in that, In step S2, during aerobic fermentation, the mass ratio of the Chinese herbal medicine powder, Bacillus subtilis, brown sugar, and water is 10-15:0.2-0.5:1-3:85-90. The aerobic fermentation is carried out at a temperature of 38-42℃ for 24-36 hours. The effective viable count of Bacillus subtilis is ≥1×10⁻⁶. 7 cfu / g.

8. The preparation method according to claim 3, characterized in that, In step S3, when using Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, and Bifidobacterium lactis as a compound probiotic for anaerobic chelation fermentation, the mass ratio of the mixture to the compound probiotic is 100:0.3-0.

5. In the compound probiotics, the mass ratio of Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, and Bifidobacterium lactis is 1:1.5-2:1:1; The effective viable counts of *Lactobacillus plantarum*, *Lactobacillus rhamnosus*, *Lactobacillus casei*, and *Bifidobacterium lactis* were ≥1×10⁻⁶. 7 cfu / g; The anaerobic chelation fermentation was carried out at a temperature of 38-42℃ for 36-144 hours.

9. The preparation method according to claim 3, characterized in that, In step S3, when using Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium lactis, Saccharomyces cerevisiae, and Rhizopus oryzae as compound probiotics for anaerobic chelation fermentation, the mass ratio of the mixture to the compound probiotics is 100:0.3-0.

5. The mass ratio of Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium lactis, Saccharomyces cerevisiae, and Rhizopus oryzae in the compound probiotics is 1:1.5-2:1:1:1:0.5-1. The effective viable counts of *Lactobacillus plantarum*, *Lactobacillus rhamnosus*, *Lactobacillus casei*, *Bifidobacterium lactis*, *Saccharomyces cerevisiae*, and *Rhizopus oryzae* were ≥1×10⁻⁶. 7 cfu / g; The anaerobic chelation fermentation was carried out at a temperature of 32-37℃ for 72 hours.

10. The use of the composition of claim 1 or 2 in the preparation of a product for regulating the spleen and liver.

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