Combined traditional Chinese medicine fermented food-nourishing composition and preparation method thereof

Abstract

The invention belongs to the field of traditional Chinese medicine food-nourishing and microbial fermentation, and particularly relates to a combined traditional Chinese medicine fermented food-nourishing composition and a preparation method thereof.The combined traditional Chinese medicine fermented food-nourishing composition comprises traditional Chinese medicine enzymolysis powder, nitric oxide regulation and control premix powder and medicinal and edible auxiliary materials; wherein the mass ratio of the traditional Chinese medicine enzymolysis powder to the nitric oxide regulation and control premix powder to the medicinal and edible auxiliary materials is 3: 1: 6. The composition shows remarkable efficacy synergy, and compared with a single traditional Chinese medicine component, through the multi-target effect of traditional Chinese medicine-strain-NO, the concentration of nitric oxide (NO) in serum is remarkably improved by 35%-45%, and the cGMP level is improved by 25%-30%. In an animal model, coronary blood flow of myocardial ischemia model rats can be effectively increased by 20%-25%, myocardial oxygen consumption can be effectively reduced by 15%-20%, systolic pressure of hypertension model mice can be reduced by 10-15 mmHg, vascular compliance can be improved by 18%-22%, and heart and vascular functions can be synergistically protected from multiple dimensions.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine dietary therapy and microbial fermentation technology, specifically to a combination of fermented traditional Chinese medicine dietary therapy compositions and their preparation methods. Background Technology

[0002] Cardiovascular health depends on the synergistic maintenance of "myocardial function-vasodilation-metabolic balance". In 1998, Ferid Murad won the Nobel Prize for discovering "the core role of nitric oxide (NO) as a vascular endothelial relaxing factor", which proved that NO promotes the production of cyclic guanosine monophosphate (cGMP) by activating guanylate cyclase (sGC), and is a key signaling molecule that regulates vasodilation and improves myocardial perfusion.

[0003] Currently, traditional Chinese medicines such as Astragalus membranaceus and Ligusticum chuanxiong have cardiotonic and vasodilatory effects, but the dissolution rate of their active ingredients is low. Certain probiotics can reduce vascular inflammation by regulating the intestinal flora, but the effect of a single strain is limited. NO synthesis depends on L-arginine precursors, but faces problems such as low absorption efficiency and easy oxidation and inactivation. Existing technologies lack a systematic integration of "traditional Chinese medicine-microorganisms-signaling molecules," making it difficult to achieve multi-target synergistic protection. Therefore, we propose a combined fermented dietary therapy composition of traditional Chinese medicine and its preparation method. Summary of the Invention

[0004] The main objective of this invention is to provide a combined fermented Chinese herbal medicine nutritional composition and its preparation method, which can solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention proposes a combined fermented Chinese medicine dietary composition, comprising Chinese medicine enzymatic hydrolysis powder, nitric oxide-regulated premixed powder, and medicinal and edible excipients; wherein the mass ratio of the Chinese medicine enzymatic hydrolysis powder, nitric oxide-regulated premixed powder, and medicinal and edible excipients is 3:1:6.

[0006] Preferably, the herbal enzymatic hydrolysate powder is prepared by the following method: herbal raw materials including Astragalus membranaceus, Cinnamomum cassia twig tip, Polygala tenuifolia (honey-processed), Ligusticum chuanxiong (wine-fried), Aconitum carmichaelii (processed), Glycyrrhiza uralensis, Polygonatum sibiricum, Ligustrum lucidum (salt-fried), Atractylodes macrocephala, Tribulus terrestris, and Cornus officinalis are fermented with a compound fermentation liquid, and then subjected to compound enzymatic hydrolysis and drying.

[0007] Preferably, the Chinese medicinal materials are composed of the following parts by weight: Astragalus membranaceus 15g, Cinnamomum cassia twig tip 12g, Polygala tenuifolia (honey-processed) 15g, Ligusticum chuanxiong (wine-fried) 15g, Aconitum carmichaelii (processed) 10g, Glycyrrhiza uralensis 10g, Polygonatum sibiricum 15g, Ligustrum lucidum (salt-fried) 15g, Atractylodes macrocephala 12g, Tribulus terrestris 10g, Cornus officinalis 15g, and the Chinese medicinal materials conform to the standards of the 2025 edition of the Chinese Pharmacopoeia.

[0008] Preferably, the compound fermentation broth contains *Lactobacillus plantarum*, *Lactobacillus reuteri*, and *Bacillus coagulans*, with a viable count ratio of 2:1:1. The strains comply with the GB4789.34-2024 food safety standard (deposited at the China General Microbiological Culture Collection Center, accession numbers: *Lactobacillus plantarum* CGMCC1.2138, *Lactobacillus reuteri* CGMCC1.3724, and *Bacillus coagulans* CGMCC1.5074).

[0009] Preferably, the nitric oxide regulating premix powder is composed of L-arginine, citrulline and grape skin polyphenols, and the mass ratio of the three is 4:2:1. The nitric oxide regulating components meet the GB14880-2022 standard for the use of food fortifiers.

[0010] Preferably, the medicinal and edible excipients are composed of yam powder, poria powder and oat powder, and the mass ratio of the three is 2:2:1.

[0011] A method for preparing a combined fermented Chinese herbal medicine dietary supplement composition includes the following steps: S1. Preparation of compound fermentation culture: Activate and expand Lactobacillus plantarum, Lactobacillus reuteri and Bacillus coagulans respectively, mix them in proportion to obtain compound fermentation culture; S2. Preparation of traditional Chinese medicine fermentation liquid: After crushing the traditional Chinese medicine raw materials, mixing them with water, sterilizing them, and then inoculating them with the compound fermentation liquid for fermentation, the supernatant is taken after fermentation to obtain the traditional Chinese medicine fermentation liquid; S3. Preparation of enzymatic hydrolysate of traditional Chinese medicine: Add a compound enzyme to the fermentation broth of traditional Chinese medicine to carry out enzymatic hydrolysis reaction, inactivate the enzyme and dry to obtain enzymatic hydrolysate of traditional Chinese medicine; S4. Preparation of nitric oxide-regulated premixed powder: L-arginine, citrulline and grape skin polyphenols are mixed to obtain NO-regulated premixed powder; S5. Mixing: Mix the enzymatic hydrolysis powder of traditional Chinese medicine, the NO-regulating premixed powder and the medicinal and edible excipients in proportion to obtain a combined fermented food composition of traditional Chinese medicine.

[0012] Preferably, in step S2, the fermentation is a two-stage fermentation, first anaerobic fermentation and then aerobic fermentation; the conditions for anaerobic fermentation are: fermentation at 36°C for 36 hours; the conditions for aerobic fermentation are: fermentation at 36°C for 24 hours.

[0013] Preferably, in step S3, the complex enzyme is composed of cellulase, pectinase and protease in a mass ratio of 3:2:1; the conditions for the enzymatic hydrolysis reaction are: 52°C, pH 5.0 for 2.5 h.

[0014] Preferably, in step S5, the mixed materials are further processed into a dosage form; the dosage form is a medicinal paste, medicinal granules, or oral liquid; When processing the ingredients into a medicinal paste, honey and purified water are added to the mixture and boiled, then cooled and packaged. When processing into medicinal food granules, add 50% ethanol to the mixture to make a soft material, granulate through a 16-mesh sieve, dry at 60℃, and then package the whole granules. When processing into an oral liquid, the mixture is dissolved in purified water at a solid-liquid ratio of 1:10, and 0.1% vitamin C is added to promote NO synthase activity. After filling, it is sterilized at 80°C for 30 minutes.

[0015] This invention provides a combined fermented Chinese herbal medicine nutritional composition and its preparation method. It possesses the following beneficial effects: (1) The composition of the present invention exhibits significant synergistic efficacy. Compared with single Chinese medicine components, the present invention significantly increases serum nitric oxide (NO) concentration by 35% to 45% and increases cyclic guanosine monophosphate (cGMP) level by 25% to 30% through the multi-target action of "Chinese medicine-strain-NO". In animal models, it can effectively increase coronary blood flow in rats with myocardial ischemia by 20% to 25%, reduce myocardial oxygen consumption by 15% to 20%, and reduce systolic blood pressure in hypertensive mice by 10-15 mmHg, and improve vascular compliance by 18% to 22%, thus synergistically protecting cardiac and vascular function from multiple dimensions.

[0016] (2) This invention significantly improves the bioavailability of key components. The unique fermentation combined with enzymatic hydrolysis process increases the dissolution rate of active ingredients such as astragaloside and ligustrazine by more than 40%, and improves the human body absorption rate by 30% to 50%. At the same time, by scientifically premixing the nitric oxide regulating components, the degradation of L-arginine in the intestine is effectively avoided, thus increasing its bioavailability by 25%. Combined with the precise dosage control of the fine powder form and the post-meal administration method, this invention improves the overall absorption rate of active ingredients by more than 50% compared with the traditional powdering process, achieving a technological breakthrough in the new use of ancient formulas.

[0017] (3) The product of this invention has higher safety and better palatability. The strains used are all food-grade safe strains, and the content of aconitine (such as in processed aconite) in the Chinese herbal raw materials is reduced by more than 50% after fermentation, ensuring the safety of long-term use. The fermentation process also effectively improves the inherent bitterness of Chinese herbal medicines, and its sensory score is significantly improved compared with traditional decoctions, making it easier for users to accept and persist in taking it.

[0018] (4) The technological innovation of this invention lies in the deep integration of multidisciplinary technologies. For the first time, it systematically integrates the nitric oxide signal regulation mechanism based on Murad's Nobel Prize-winning findings, a specific combination of cardioprotective strains, and traditional Chinese medicine compatibility, forming a synergistic system of "multi-target-multi-pathway". Its preparation process fully considers the activity of the strains, the conversion efficiency of Chinese medicine components, and the stability of nitric oxide-regulated components, providing a reliable guarantee for industrial application. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of the preparation method steps of the present invention; Figure 2 Experimental data table for this invention Figure 1 ; Figure 3 Experimental data table for this invention Figure 2 .

[0021] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] Please see Figure 1 - Figure 3 This invention proposes a combined fermented Chinese medicine dietary composition, comprising Chinese medicine enzymatic hydrolysis powder, nitric oxide-regulated premixed powder, and medicinal and edible excipients; wherein the mass ratio of Chinese medicine enzymatic hydrolysis powder, nitric oxide-regulated premixed powder, and medicinal and edible excipients is 3:1:6.

[0024] In an embodiment of the present invention, the enzymatic hydrolysis powder of traditional Chinese medicine is prepared by the following method: Traditional Chinese medicine raw materials including Astragalus membranaceus, Cinnamomum cassia twig, Polygala tenuifolia (honey-processed), Ligusticum chuanxiong (wine-fried), Aconitum carmichaelii (processed), Glycyrrhiza uralensis, Polygonatum sibiricum, Ligustrum lucidum (salt-fried), Atractylodes macrocephala, Tribulus terrestris, and Cornus officinalis are fermented with a compound fermentation broth, followed by compound enzymatic hydrolysis and drying. Specifically, Astragalus membranaceus (astragaloside) + Cinnamomum cassia twig (cinnamaldehyde) enhances myocardial contractility, activates endothelial NO synthase (eNOS), and promotes NO synthesis; Ligusticum chuanxiong (wine-fried) (ligustrazine) + Cornus officinalis (monoside) improves myocardial microcirculation, inhibits platelet aggregation, and synergistically inhibits thrombosis with NO; Polygonatum sibiricum (Polygonatum polysaccharide) + Atractylodes macrocephala (Atractylodes macrocephala lactone) regulates glucose and lipid metabolism, reduces cardiac load, and provides a stable internal environment for NO synthesis.

[0025] The proportions of the Chinese medicinal materials strictly follow the core dosages recorded in the "Wang Family Medical Records," such as "Astragalus membranaceus 15g, Cinnamomum cassia twig tip 12g," preserving the essence of the ancestral formula: "warming yang without harming yin, and invigorating blood without depleting qi." The processing methods for honey-processed Polygala tenuifolia and salt-fried Ligustrum lucidum continue the family's traditional techniques of "honey-processing to increase moisture and salt-frying to nourish the kidneys." The Chinese medicinal materials consist of the following parts by weight: Astragalus membranaceus 15g, Cinnamomum cassia twig tip 12g, honey-processed Polygala tenuifolia 15g, wine-fried Ligusticum chuanxiong 15g, processed Aconitum carmichaelii 10g, Glycyrrhiza uralensis 10g, Polygonatum sibiricum 15g, salt-fried Ligustrum lucidum 15g, Atractylodes macrocephala 12g, Tribulus terrestris 10g, Cornus officinalis 15g. The Chinese medicinal materials meet the standards of the 2025 edition of the Chinese Pharmacopoeia.

[0026] Furthermore, the compound fermentation broth contains *Lactobacillus plantarum*, *Lactobacillus reuteri*, and *Bacillus scoagulans*, with a viable count ratio of 2:1:1. The strains comply with GB4789.34-2024 food safety standards (deposited at the China General Microbiological Culture Collection Center, accession number: *Lactobacillus plantarum* CGMCC1.2138, *Lactobacillus reuteri*). Lactobacillus reuteri CGMCC1.3724 and Bacillus coagulans CGMCC1.5074, through Lactobacillus plantarum: produce antioxidant peptides (such as glutathione) to reduce NO oxidation inactivation; through Lactobacillus reuteri: secrete reuterin to inhibit harmful intestinal bacteria (such as Escherichia coli) and reduce vascular inflammation caused by endotoxin (LPS); through Bacillus coagulans: produce short-chain fatty acids (SCFA) to enhance sGC activity and amplify the NO-cGMP signaling pathway; the three are combined in a 2:1:1 ratio to synergistically improve gut-heart axis function.

[0027] Furthermore, the nitric oxide regulating premix powder is composed of L-arginine, citrulline, and grape skin polyphenols, with a mass ratio of 4:2:1. The nitric oxide regulating component complies with the GB14880-2022 standard for the use of food fortifiers. (Note:) The nitric oxide regulating component is based on Murad's technology. L-arginine: a direct precursor for NO synthesis, providing substrates; citrulline: circulates to arginine, continuously replenishing precursors and solving the oral absorption bottleneck; grape skin polyphenols (containing resveratrol and anthocyanins): scavenge superoxide anions, protecting NO from being oxidized to inactive ONOO⁻. The three components synergistically construct a NO regulation chain of "precursor supply - activity protection": traditional Chinese medicine activates eNOS → strains optimize the metabolic environment (reducing inflammation and enhancing sGC activity) → the NO regulating component ensures substrate and activity → together improve myocardial perfusion and vasodilation function.

[0028] Furthermore, the medicinal and edible excipients consist of yam powder, poria powder, and oat powder, with a mass ratio of 2:2:1.

[0029] A method for preparing a combined fermented Chinese herbal medicine dietary supplement composition includes the following steps: S1. Preparation of compound fermentation culture: Activate and expand Lactobacillus plantarum, Lactobacillus reuteri and Bacillus coagulans respectively, mix them in proportion to obtain compound fermentation culture; S2. Preparation of Chinese herbal medicine fermentation liquid: After crushing the Chinese herbal raw materials, mixing them with water, sterilizing them, and then inoculating them with compound fermentation bacteria liquid for fermentation, the supernatant is taken after fermentation to obtain the Chinese herbal medicine fermentation liquid; S3. Preparation of enzymatic hydrolysate of traditional Chinese medicine: Add a compound enzyme to the fermentation broth of traditional Chinese medicine to carry out enzymatic hydrolysis reaction, inactivate the enzyme and dry to obtain enzymatic hydrolysate of traditional Chinese medicine; S4. Preparation of nitric oxide-regulated premixed powder: L-arginine, citrulline and grape skin polyphenols are mixed to obtain NO-regulated premixed powder; S5. Mixing: Mix the enzymatic hydrolysis powder of traditional Chinese medicine, the NO-regulating premixed powder and the medicinal and edible excipients in proportion to obtain a combined fermented food composition of traditional Chinese medicine.

[0030] Furthermore, in step S2, the fermentation is a two-stage fermentation process, first anaerobic fermentation and then aerobic fermentation; the anaerobic fermentation conditions are: fermentation at 36℃ for 36 hours; the aerobic fermentation conditions are: fermentation at 36℃ for 24 hours. In step S3, the compound enzyme is composed of cellulase, pectinase, and protease in a mass ratio of 3:2:1; the enzymatic hydrolysis conditions are: enzymatic hydrolysis at 52℃ and pH 5.0 for 2.5 hours. In step S5, the mixed material is further processed into a dosage form; the dosage form is a medicinal paste, medicinal granules, or oral liquid. When processing the ingredients into a medicinal paste, honey and purified water are added to the mixture and boiled, then cooled and packaged. When processing into medicinal food granules, add 50% ethanol to the mixture to make a soft material, granulate through a 16-mesh sieve, dry at 60℃, and then package the whole granules. When processing into an oral liquid, the mixture is dissolved in purified water at a solid-liquid ratio of 1:10, and 0.1% vitamin C is added to promote NO synthase activity. After filling, it is sterilized at 80°C for 30 minutes.

[0031] Example 1: Preparation of a combined fermented Chinese herbal medicine dietary supplement (medicinal paste) 1. Raw material preparation: Chinese herbal ingredients: Weigh and mix the following ingredients in the following proportions: Astragalus membranaceus 15g, Cinnamomum cassia twig tip 12g, Polygala tenuifolia (honey-processed) 15g, Ligusticum chuanxiong (wine-fried) 15g, Aconitum carmichaelii (processed) 10g, Glycyrrhiza uralensis 10g, Polygonatum sibiricum 15g, Ligustrum lucidum (salt-fried) 15g, Atractylodes macrocephala 12g, Tribulus terrestris 10g, and Cornus officinalis 15g.

[0032] Strains: Lactobacillus plantarum CGMCC1.2138, Lactobacillus reuteri CGMCC1.3724, and Bacillus coagulans CGMCC1.5074 (with a live count ratio of 2:1:1).

[0033] NO-regulating components: L-arginine 20g, citrulline 10g, grape skin polyphenols 5g.

[0034] Additional ingredients: 200g yam powder, 200g poria powder, 100g oat flour, 300g honey.

[0035] 2. Preparation of compound fermentation broth (S1): Lactobacillus plantarum was inoculated into MRS medium and cultured anaerobically at 37°C for 20 h; Lactobacillus reuteri was inoculated into MRS medium and cultured anaerobically at 35°C for 24 h; Bacillus coagulans was inoculated into nutrient broth medium and cultured aerobically at 37°C for 18 h.

[0036] Mix the three bacterial solutions mentioned above at a live bacteria ratio of 2:1:1, and adjust the live bacteria concentration to 1×10⁻⁶. 9 CFU / mL was used to obtain a compound fermentation broth.

[0037] 3. Preparation of traditional Chinese medicine fermentation broth (S2): The mixed Chinese herbal raw materials are crushed and passed through a 100-mesh sieve to obtain mixed medicinal powder.

[0038] Mix the mixed powder with distilled water at a mass ratio of 1:9, add glucose (based on the mass of the powder) at 2% of the powder mass as a carbon source, adjust the pH to 6.8, and sterilize at 121℃ and 0.1MPa for 25 minutes.

[0039] After cooling, add a compound fermentation liquid equivalent to 7% of the total mass of the fermentation system, and ferment anaerobically for 36 hours at 36℃, followed by aerobic fermentation for 24 hours.

[0040] After fermentation, the mixture was allowed to stand at 4°C for 12 hours, then centrifuged at 3000 rpm for 15 minutes. The supernatant was then collected to obtain the fermented liquid of traditional Chinese medicine.

[0041] 4. Preparation of enzymatic hydrolysate of traditional Chinese medicine (S3): Add a compound enzyme (cellulase: pectinase: protease = 3:2:1) equivalent to 0.6% of the fermentation liquid mass to the fermentation liquid, and enzymatically hydrolyze for 2.5 h at 52℃ and pH 5.0.

[0042] After enzymatic hydrolysis, the enzyme was inactivated by heating at 95℃ for 12 minutes.

[0043] The traditional Chinese medicine enzymatic hydrolysate powder (50g) was obtained by spray drying (inlet air temperature 185℃, outlet air temperature 85℃).

[0044] 5. Preparation of NO-regulated premixed powder (S4): L-arginine and citrulline were passed through an 80-mesh sieve, and grape skin polyphenols were extracted by supercritical CO2 (purity ≥90%). The mixtures were then homogenized at a mass ratio of 4:2:1 to obtain NO-regulating premixed powder (35g).

[0045] 6. Mixing and Formulation (S5): The obtained Chinese herbal enzymatic hydrolysis powder, NO-regulating premixed powder, and food-medicine homologous excipients (yam powder: poria powder: oat powder = 2:2:1) were mixed evenly at a mass ratio of 3:1:6.

[0046] To process into a medicinal paste: add honey equivalent to 0.5 times its mass and an appropriate amount of purified water to the above mixture, heat and boil until the relative density is 1.25, cool and then package.

[0047] Example 2: Preparation of a combined fermented Chinese herbal medicine dietary therapy composition (medicinal food granules) Steps S1 to S4 are the same as in Example 1, yielding 50g of enzymatic hydrolysate of traditional Chinese medicine and 35g of NO premixed powder. The enzymatic hydrolysate is then ultra-finely pulverized (particle size ≤10μm) to form a fine powder.

[0048] In mixtures and formulations: Mix the enzymatic hydrolysate of traditional Chinese medicine, NO-regulating premixed powder, and food-medicine homologous excipients (Poria cocos powder: oat powder: red yeast rice powder = 4:2:1) evenly at a mass ratio of 3:1:6.

[0049] Processing into medicinal food granules: Add 50% (v / v) ethanol solution to the mixture to make soft material, granulate through a 16-mesh sieve, dry at 60℃ (this temperature is beneficial to protect the activity of L-arginine), granulate and package to obtain (8g per bag, specifications include 3g / bag and 5g / bag).

[0050] Example 3: Preparation of a combined fermented Chinese herbal medicine dietary therapy composition (oral liquid) Steps S1 to S4 are the same as in Example 1.

[0051] In step S5: Mix the enzymatic hydrolysis powder of traditional Chinese medicine, the NO-regulating premixed powder, and the food-medicine homologous excipients (yam powder: poria powder: oat powder = 2:2:1) evenly in a mass ratio of 3:1:6.

[0052] Processing into oral liquid: Dissolve the mixture in purified water (solid-liquid ratio of 1:10), add vitamin C equivalent to 0.1% of the total mass of the solution, stir evenly, fill into bottles, and sterilize at 80℃ for 30 minutes to obtain the oral liquid.

[0053] Case study (based on the method of administration of fine powder and fermentation + NO control technology) (I) Experimental Design Description Sixty individuals with sub-health conditions and mild symptoms who met the criteria of "insufficient heart yang and decreased vascular endothelial function" were selected from July 2023 to December 2023 and randomly divided into an experimental group (fermented + NO-regulated fine powder of this invention) and a control group (traditional unfermented fine powder), with 30 cases in each group. The intervention lasted for 4 weeks.

[0054] Experimental group: Fine powder made using the process of this invention (heart strain fermentation + enzymatic hydrolysis + NO regulating components), taken with warm water 10-15 minutes after meals, 3g each time, twice a day (5g each time for those with more severe symptoms).

[0055] Control group: Traditional herbal formula powder (unfermented, no NO-regulating components), taken in the same way and at the same dosage as the experimental group.

[0056] (II) Typical cases in the experimental group Case 1: Mr. Chen, male, 60 years old, chief complaint of "palpitation and chest tightness after activity for 3 months". Western medicine examination: serum NO concentration 32μmol / L, systolic blood pressure 140mmHg, vascular endothelial-dependent diastolic function (FMD) 5.0%.

[0057] Intervention plan: Take 3g of the fine powder of this invention twice a day, 12 minutes after meals.

[0058] Intervention results: One week later: The frequency of palpitations decreased from twice a day to once a day, and the patient felt "no stomach discomfort after taking the medication (because taking it after meals reduces stimulation)"; Two weeks later: serum NO concentration rose to 45 μmol / L, chest tightness was relieved, and he could walk slowly for 1000 meters without discomfort; Four weeks later: Palpitations disappeared, NO concentration was 58 μmol / L, systolic blood pressure was 128 mmHg, FMD rose to 6.7%, and follow-up liver and kidney function tests showed no abnormalities.

[0059] Case 2: Ms. Liu, 56 years old, chief complaint: "cold hands and feet, fatigue for half a year, accompanied by high blood lipids (TC 6.1 mmol / L)", pale tongue with white coating, deep pulse. Intervention plan: The fine powder of this invention (5g each time for more severe symptoms) is taken twice a day, 10 minutes after meals.

[0060] Intervention results: Two weeks later: The hands and feet returned to a warm temperature, and the fatigue lessened. The patient reported that "the fine powder is easy to take and does not have the roughness of traditional medicine powder (due to the ultra-fine grinding process)." Four weeks later: TC decreased to 5.0 mmol / L, serum NO concentration increased from 30 μmol / L to 52 μmol / L, tongue coating became moist, and pulse depth improved.

[0061] A corresponding table has been generated based on the above data and can be used for reference. Figure 2 As shown (III) Typical cases in the control group (traditional fine flour, without fermentation and NO regulation) Case 3: Mr. Zhang, male, 63 years old, with symptoms the same as Case 1 in the experimental group (palpitation, chest tightness, NO 33μmol / L).

[0062] Intervention plan: Traditional unfermented fine powder, 3g each time, twice a day, taken after meals.

[0063] Intervention results: Four weeks later: the frequency of palpitations decreased from twice a day to three times a week, the NO concentration increased to 40 μmol / L, and the FMD was 5.5%, which was less than that of the experimental group.

[0064] A corresponding table has been generated based on the above data and can be used for reference. Figure 2 As shown (iv) Comparative trial data (4-week intervention results, ±s) Indicator: Experimental group (n=30) - Control group (n=30) - Difference between groups (P-value) Subjective symptom score (0-10 points, the lower the better) Heart palpitations Before intervention: 5.3±1.2, Before intervention: 5.2±1.1, >0.05; Post-intervention: 0.9±0.5; Post-intervention: 3.1±0.8; <0.01; Chest tightness Before intervention: 4.9±1.0, Before intervention: 4.8±1.0, >0.05; Post-intervention: 0.8±0.4; Post-intervention: 2.9±0.7; <0.01; Medication adherence (%): 96.7 (due to the good palatability of fine powder), 73.3 (traditional fine powder has a rough texture), <0.01; Objective biochemical indicators Serum NO concentration (μmol / L) Before intervention: 33.5±5.4; Before intervention: 33.2±5.3; >0.05; Post-intervention: 57.2±6.1; Post-intervention: 41.8±5.6; <0.01; Systolic blood pressure (mmHg) Before intervention: 141.5±8.3; Before intervention: 141.2±8.1; >0.05; Post-intervention: 127.8±6.2; Post-intervention: 136.5±7.0; <0.01; Total cholesterol (TC, mmol / L) Before intervention: 5.8±0.5, Before intervention: 5.7±0.5, >0.05; Post-intervention: 4.8±0.3; Post-intervention: 5.4±0.4; <0.01; Incidence of gastrointestinal discomfort (%) 0.00, 13.3, (4 cases); A corresponding table has been generated based on the above data and can be used for reference. Figure 3 As shown VI. Experimental Conclusions 1. The experimental group (fermented + NO-regulating fine powder of this invention, taken 10-15 minutes after meals, 3-5g / time) was significantly better than the control group (traditional unfermented fine powder) in improving symptoms such as palpitations and chest tightness, increasing serum NO concentration, and lowering blood pressure and blood lipids. Moreover, due to the ultra-fine pulverization process, the taste was better and the medication compliance reached 96.7%.

[0065] 2. The fine powder formulation, combined with the post-meal administration method, reduces gastrointestinal irritation (no cases of stomach discomfort occurred in the experimental group, while 4 cases occurred in the control group), demonstrating the advantages of "high efficiency + safety".

[0066] 3. Experiments have confirmed that the new technology system of "fermentation transformation + NO regulation + fine powder dosage form + precise administration" of this invention significantly improves the bioavailability and clinical efficacy of traditional formulas compared with traditional methods, and is a modern innovation of traditional prescriptions.

[0067] Note: Murad's technical findings are cited in "Nitric oxide: a physiologic messenger molecule", Science, 1992; and "The role of nitric oxide in cardiovascular function", Circulation Research, 2006. Appendix: Evidence of the inheritance of the ancestral recipe The core compatibility and dosage of the Chinese herbal raw materials in this invention are based on the handwritten copy of "Wang Family Medical Cases" (1948) provided by Dr. Wang Xinbao and proof of family inheritance. Its traditional application history can be traced back to before 1900. Relevant literature and physical evidence have been archived for future reference.

[0068] Appendix: Supporting materials from the experiment The fine powder formulation used in this experiment was tested by a third party (particle size distribution: D90=8.5μm) and met the "Technical Specifications for Food Micronized Powder Processing". The method of administration was verified by a traditional Chinese medicine expert on spleen and stomach. "Taking it 10-15 minutes after meals" can follow the rise of stomach qi and promote absorption. The original data is archived in Dr. Wang Xinbao's studio.

[0069] The above description is merely a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. A combination of fermented traditional Chinese medicine dietary supplements, characterized in that: It includes enzymatic hydrolysate of traditional Chinese medicine, nitric oxide-regulated premixed powder, and food-medicine homologous excipients; wherein the mass ratio of the enzymatic hydrolysate of traditional Chinese medicine, nitric oxide-regulated premixed powder, and food-medicine homologous excipients is 3:1:

6.

2. The combined fermented Chinese herbal medicine nutritional composition according to claim 1, characterized in that, The herbal enzymatic hydrolysate powder is prepared by the following method: Herbal raw materials including Astragalus membranaceus, Cinnamomum cassia twig tip, Polygala tenuifolia (honey-processed), Ligusticum chuanxiong (wine-fried), Aconitum carmichaelii (processed), Glycyrrhiza uralensis, Polygonatum sibiricum, Ligustrum lucidum (salt-fried), Atractylodes macrocephala, Tribulus terrestris, and Cornus officinalis are fermented with a compound fermentation liquid, and then subjected to compound enzymatic hydrolysis and drying.

3. The combined fermented Chinese herbal medicine nutritional composition according to claim 2, characterized in that, The Chinese medicinal materials consist of the following parts by weight: Astragalus membranaceus 15g, Cinnamomum cassia twig tip 12g, Polygala tenuifolia (honey-processed) 15g, Ligusticum chuanxiong (wine-fried) 15g, Aconitum carmichaelii (processed) 10g, Glycyrrhiza uralensis 10g, Polygonatum sibiricum 15g, Ligustrum lucidum (salt-fried) 15g, Atractylodes macrocephala 12g, Tribulus terrestris 10g, Cornus officinalis 15g.

4. The combined fermented Chinese herbal medicine nutritional composition according to claim 2, characterized in that, The compound fermentation broth contains Lactobacillus plantarum, Lactobacillus reuteri, and Bacillus coagulans, with a live bacteria ratio of 2:1:

1.

5. The combined fermented Chinese herbal medicine nutritional composition according to claim 1, characterized in that, The nitric oxide-regulated premixed powder is composed of L-arginine, citrulline, and grape skin polyphenols, with a mass ratio of 4:2:

1.

6. The combined fermented Chinese herbal medicine nutritional composition according to claim 1, characterized in that, The medicinal and edible excipients consist of yam powder, poria powder and oat powder, and the mass ratio of the three is 2:2:

1.

7. A method for preparing a combined fermented Chinese herbal medicine dietary composition as described in any one of claims 1-6, characterized in that, Includes the following steps: S1. Preparation of compound fermentation culture: Activate and expand Lactobacillus plantarum, Lactobacillus reuteri and Bacillus coagulans respectively, mix them in proportion to obtain compound fermentation culture; S2. Preparation of traditional Chinese medicine fermentation liquid: After crushing the traditional Chinese medicine raw materials, mixing them with water, sterilizing them, and then inoculating them with the compound fermentation liquid for fermentation, the supernatant is taken after fermentation to obtain the traditional Chinese medicine fermentation liquid; S3. Preparation of enzymatic hydrolysate of traditional Chinese medicine: Add a compound enzyme to the fermentation broth of traditional Chinese medicine to carry out enzymatic hydrolysis reaction, inactivate the enzyme and dry to obtain enzymatic hydrolysate of traditional Chinese medicine; S4. Preparation of nitric oxide-regulated premixed powder: L-arginine, citrulline and grape skin polyphenols are mixed to obtain NO-regulated premixed powder; S5. Mixing: Mix the enzymatic hydrolysis powder of traditional Chinese medicine, the NO-regulating premixed powder and the medicinal and edible excipients in proportion to obtain a combined fermented food composition of traditional Chinese medicine.

8. The preparation method according to claim 7, characterized in that, In step S2, the fermentation is a two-stage fermentation, first anaerobic fermentation and then aerobic fermentation; the conditions for anaerobic fermentation are: fermentation at 36℃ for 36 hours; the conditions for aerobic fermentation are: fermentation at 36℃ for 24 hours.

9. The preparation method according to claim 7, characterized in that, In step S3, the complex enzyme is composed of cellulase, pectinase and protease in a mass ratio of 3:2:1; the conditions for the enzymatic hydrolysis reaction are: 52℃, pH 5.0 for 2.5h.

10. The preparation method according to claim 7, characterized in that, In step S5, the mixed materials are further processed into a dosage form; the dosage form is a medicinal paste, medicinal granules, or oral liquid; When processing the ingredients into a medicinal paste, honey and purified water are added to the mixture and boiled, then cooled and packaged. When processing into medicinal food granules, add 50% ethanol to the mixture to make a soft material, granulate through a 16-mesh sieve, dry at 60℃, and then package the whole granules. When processing into an oral liquid, the mixture is dissolved in purified water, 0.1% vitamin C is added, and after filling, it is sterilized at 80°C for 30 minutes.

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