Probiotic fermented medicinal and edible traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a probiotic-fermented medicinal and edible traditional Chinese medicine composition as well as a preparation method and application thereof. Specifically, the medicinal and edible traditional Chinese medicine composition comprises the following components: Chinese yam, lotus seed, white hyacinth bean, fingered citron, dandelion, coix seed, Chinese date, malt and liquorice. According to the invention, the medicinal and edible traditional Chinese medicine raw materials are crushed, and the probiotics are added for fermentation treatment, so that the medicinal and edible traditional Chinese medicine composition based on probiotic fermentation is obtained, and the composition has a good curative effect on chronic diseases such as gastrointestinal diseases and the like, thereby having a good practical application value.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a probiotic fermented traditional Chinese medicine composition that is both food and medicine, its preparation method, and its application. Background Technology

[0002] The treatment of chronic diseases is a long and complex process, encompassing strategies such as healthy lifestyles, regular checkups, rational drug use, and community and family support. Only through comprehensive treatment strategies can the incidence of chronic diseases be effectively controlled and patients' quality of life improved. Furthermore, fermented products of traditional Chinese medicine, due to their unique efficacy and easy absorption, are gradually becoming an important component of rational drug use and treatment.

[0003] The advantages of fermented traditional Chinese medicine (TCM) lie in its ability to effectively extract the active ingredients from medicinal materials, thereby improving their utilization rate. Under the action of microorganisms, the active ingredients of TCM can be fully released, while various biological enzymes are produced, promoting the decomposition and transformation of complex components in the medicinal materials. The small-molecule aglycones and saponins produced during fermentation are more easily absorbed and utilized by the human body, thus improving the absorption and utilization rates of the drugs. Simultaneously, the decomposition of toxic components and the generation of metabolites during fermentation reduce the toxicity of the drugs and improve their taste. More importantly, the new components generated during the structural transformation of fermented TCM often possess stronger pharmacological activity, bringing new breakthroughs to the treatment of chronic diseases. Furthermore, fermented TCM also shows great potential in saving medicinal resources and reducing costs, alleviating the economic burden on patients with chronic diseases who require long-term drug treatment.

[0004] Traditional Chinese medicine (TCM) has garnered significant attention from scholars both domestically and internationally due to its unique advantages of being green and natural, having few side effects, and exhibiting low drug resistance. To accelerate the industrialization of TCM and enhance the value and quality of TCM products, scholars have conducted a series of innovative studies on TCM manufacturing processes, such as "ultra-micro pulverization of TCM," "TCM granule preparations," and "vacuum drying of TCM." With the advancement of science and technology, the comprehensive and synergistic research on TCM materials and microorganisms—two major sources of natural active substances—has attracted widespread interest, with research on the fermentation of TCM materials through microorganisms receiving considerable attention. Summary of the Invention

[0005] Based on the aforementioned prior art, this invention provides a probiotic-fermented medicinal and edible herbal composition, its preparation method, and its application. Specifically, this invention involves pulverizing medicinal and edible herbal raw materials and simultaneously adding probiotics for fermentation, thereby obtaining a probiotic-fermented medicinal and edible herbal composition. This composition has good therapeutic effects on chronic diseases such as gastrointestinal disorders. This invention is completed based on the above research results.

[0006] In a first aspect, the present invention provides a medicinal and edible herbal composition fermented with probiotics, the medicinal and edible herbal composition comprising the following components: Yam, lotus seeds, white hyacinth bean, Buddha's hand, dandelion, Job's tears, jujube, malt, and licorice.

[0007] Among them, yam is sweet in taste and neutral in nature. It enters the spleen, lung and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting body fluid and benefiting the lungs, and tonifying the kidneys and astringing essence. It mainly contains starch, mucilage (containing mannan and phytic acid), yam polysaccharide, diosgenin, amino acids such as glutamic acid, as well as vitamin C, potassium, etc. It is mainly used to treat poor appetite, chronic diarrhea and abdominal distension caused by spleen and stomach weakness, dry cough with little phlegm, dry throat and thirst caused by lung yin deficiency, and soreness of the waist and knees, frequent urination and seminal emission caused by kidney yin deficiency. It can also be used for weakness and emaciation, diabetes and other diseases.

[0008] Lotus seeds are sweet and astringent in taste, neutral in nature, and enter the spleen, kidney, and heart meridians. They have the effects of tonifying the spleen and stopping diarrhea, benefiting the kidneys and astringing, and nourishing the heart and calming the mind. They mainly contain starch, protein, lotus seed polysaccharides, lotus seed alkaloids, flavonoids such as rutin, and minerals such as phosphorus and potassium. They are mainly used to treat chronic diarrhea, loss of appetite, and abdominal distension caused by spleen and stomach weakness; seminal emission, spermatorrhea, frequent urination, and excessive vaginal discharge caused by kidney deficiency; palpitations, insomnia, and dreaminess caused by restlessness; and can also be used for symptoms such as vexation and thirst.

[0009] White hyacinth bean is sweet in taste and slightly warm in nature. It enters the spleen and stomach meridians and has the effects of strengthening the spleen and removing dampness, harmonizing the middle and relieving summer heat, and detoxifying. It mainly contains protein, starch, white hyacinth bean polysaccharide, hyacinth bean saponin, flavonoids such as rutin, as well as calcium and phosphorus. It is mainly used to treat poor appetite, loose stools, abdominal distension, and heaviness of limbs caused by spleen and stomach weakness and dampness, as well as summer dampness-induced vomiting and diarrhea, chest tightness, and thirst. It can also be used for vomiting and diarrhea caused by fish and crab poisoning.

[0010] Buddha's hand fruit has a pungent, bitter, and sour taste, and is warm in nature. It enters the liver, spleen, stomach, and lung meridians. It has the effects of soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm. It mainly contains volatile oils such as limonene, coumarins such as bergamot lactone, flavonoids such as hesperidin, and organic acids such as citric acid. It is mainly used to treat chest and rib pain, depression, and belching caused by liver qi stagnation; stomach pain, poor appetite, vomiting, and hiccups caused by spleen and stomach qi stagnation; cough with excessive phlegm and chest tightness caused by lung dryness and dampness; and it can also be used for globus hystericus.

[0011] Job's tears are sweet and bland in taste, cool in nature, and enter the spleen, stomach, and lung meridians. They have the effects of strengthening the spleen and removing dampness, relieving numbness and stopping diarrhea, and clearing heat and draining pus. They mainly contain starch, protein, coix seed ester, coix seed polysaccharide, β-sitosterol, etc. They are mainly used to treat poor appetite, loose stools, abdominal distension, and edema caused by spleen deficiency and dampness, joint redness, swelling, pain, and difficulty in flexion and extension caused by damp-heat arthralgia, chest pain, abdominal pain, and fever caused by lung abscess and intestinal abscess, and can also be used for skin dampness syndromes such as eczema and damp sores.

[0012] Jujubes are sweet and warm in nature, and enter the spleen, stomach, and heart meridians. They have the effects of tonifying the middle energizer and replenishing qi, nourishing blood and calming the mind, and moderating the properties of other medicines. They mainly contain sugars such as glucose, jujube polysaccharides, flavonoids such as rutin, organic acids such as malic acid, as well as vitamin C and potassium. They are mainly used to treat symptoms such as poor appetite, fatigue, loose stools, and dull abdominal pain caused by spleen and stomach weakness; sallow complexion, dizziness, and palpitations caused by blood deficiency; and insomnia and dreaminess caused by restlessness. They can also be used to harmonize the properties of strong medicines and reduce irritation to the gastrointestinal tract.

[0013] Malt has a sweet taste and neutral properties, and enters the spleen, stomach, and liver meridians. It has the effects of promoting digestion and stomach health, soothing the liver and relieving depression, and reducing lactation and bloating. It mainly contains amylases such as α-amylase, maltose, malt polysaccharides, flavonoids such as quercetin, and B vitamins. It is mainly used to treat abdominal distension, belching, loss of appetite, and foul-smelling stools caused by food stagnation (especially good for treating food stagnation caused by rice and flour), chest and rib pain and belching caused by liver qi stagnation, and can also be used for breast bloating caused by milk stasis after weaning in women.

[0014] Licorice has a sweet taste and neutral properties. It enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing various medicines. It mainly contains triterpenoid saponins such as glycyrrhizic acid, flavonoids such as glycyrrhizin, glycyrrhizin polysaccharides, and B vitamins. It is mainly used to treat poor appetite, fatigue, and loose stools caused by spleen and stomach weakness; palpitations and irregular pulse caused by insufficient heart qi; cough with excessive phlegm caused by lung deficiency; carbuncles, boils, sore throat, abdominal cramps and pain in the limbs. It can also be used to harmonize the properties of various medicines in a prescription and reduce toxic side effects.

[0015] In another specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: 18-23 parts yam, 12-17 parts lotus seeds, 12-17 parts white hyacinth bean, 7-12 parts Buddha's hand, 7-12 parts dandelion, 12-17 parts coix seed, 5-10 parts jujube, 10-15 parts malt, and 3-8 parts licorice.

[0016] In another specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: 20-22 parts yam, 14-16 parts lotus seeds, 14-16 parts white hyacinth bean, 8-11 parts Buddha's hand, 8-11 parts dandelion, 13-16 parts coix seed, 6-9 parts jujube, 11-14 parts malt, and 5-6 parts licorice.

[0017] In another specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: 20 parts yam, 15 parts lotus seeds, 15 parts white hyacinth bean, 10 parts Buddha's hand, 10 parts dandelion, 15 parts coix seed, 8 parts jujube, 12 parts malt and 6 parts licorice.

[0018] The above-mentioned traditional Chinese medicine composition is fermented with probiotics, including but not limited to lactobacilli or streptococci. The lactobacilli include *Lactobacillus acidophilus*, *Lactobacillus gasseri*, *Lactobacillus plantarum*, *Lactobacillus helveticus*, *Lactobacillus salivarius*, *Lactobacillus fermentum*, and *Lactobacillus deuterans* subsp. bulgaricus. The streptococci include *Streptococcus salivarius* subsp. thermophilus. Further, the probiotics are a combination of *Lactobacillus plantarum* CICC 20317 and *Lactobacillus helveticus* CICC 6102. These strains are derived from the China Industrial Microbial Culture Collection Center (CICC).

[0019] A second aspect of the present invention provides a method for preparing the above-mentioned medicinal and edible herbal composition, the method comprising: S1. Select raw materials from the compound of medicinal and edible Chinese herbs, mix them, pulverize them, sieve them, and mix them again to obtain a fine powder of raw material mixture. S2. Add probiotics to the raw material mixture and carry out fermentation to obtain fermented raw material drug; S3. The fermented raw material is decocted to obtain a medicinal liquid, which is then concentrated and freeze-dried to obtain freeze-dried powder.

[0020] In this invention, In step S1, the sieve mesh size is 50-80 mesh.

[0021] In step S2, the probiotics are preferably a combination of *Lactobacillus plantarum* CICC 20317 and *Lactobacillus helveticus* CICC 6102, with a CFU ratio of 0.5-5:1, preferably 1:1. The viable count of each probiotic before being added to the raw material powder mixture is controlled at 1.5-2 billion CFU / g.

[0022] The fermentation temperature should be controlled at 30-38℃, and the fermentation humidity should be controlled at 70-80%. The fermentation time should be controlled at 24-48 hours.

[0023] The amount of probiotics added to the raw material mixture powder is controlled at 8-15% (w / w), preferably 10%.

[0024] In step S3, the fermented raw material is boiled with water for 20-40 minutes; the material-to-liquid ratio is 1:8-10 (w / w); and the liquid is filtered through gauze.

[0025] A third aspect of the present invention provides the application of the above-mentioned food-medicine homology composition in the preparation of products for chronic diseases.

[0026] The products include, but are not limited to, food and pharmaceuticals.

[0027] The term "food" can be understood as any edible form. For example, the food in this invention includes ordinary food and special food. The special food in this invention includes health food and food for special medical purposes. Ordinary food, in contrast to special food, is food suitable for everyone.

[0028] The drug can be administered in unit doses, and the dosage form can be liquid or solid. Liquid dosage forms can be true solutions, colloids, microparticles, emulsions, or suspensions. Other dosage forms include tablets, capsules, pellets, aerosols, pills, powders, solutions, emulsions, granules, suppositories, lyophilized powders for injection, inclusion complexes, and implants. The drug can be used by humans and non-human animals.

[0029] Furthermore, the product may be a solid beverage.

[0030] In this invention, the chronic diseases include, but are not limited to, gastrointestinal diseases, cardiovascular diseases, and diabetes, with gastrointestinal diseases being preferred, especially gastric and duodenal ulcers of the spleen and stomach deficiency combined with qi stagnation and dampness obstruction type.

[0031] Specifically, the traditional Chinese medicine composition of this invention, which is both food and medicine, follows the treatment principle of "strengthening the spleen and stomach, regulating qi and eliminating dampness, and combining clearing and nourishing." In this formula, yam is the principal ingredient, neutral in nature and sweet in taste, entering the spleen, lung, and kidney meridians. It can directly replenish the qi of the spleen and stomach and nourish the stomach yin. Its medicinal properties are mild, neither greasy nor drying, making it suitable for long-term treatment of spleen and stomach weakness-type ulcers, and it is the core of the formula. Jujube and white hyacinth bean are the assistant ingredients. Jujube assists yam in replenishing qi and also soothes stomach discomfort and reduces irritation to the ulcer site; white hyacinth bean strengthens the spleen and eliminates dampness, targeting the internal retention of dampness that may accompany spleen and stomach weakness (such as abdominal distension and loose stools), enhancing the spleen-strengthening effect of the principal ingredient. Buddha's hand citron, dandelion, lotus seed, and coix seed are used as adjuvant herbs. Buddha's hand citron soothes the liver and regulates qi, relieving "liver qi invading the stomach" caused by emotional fluctuations (such as anxiety and stress), thus reducing stomach pain and bloating. Dandelion clears stomach heat: targeting "stomach heat" (such as dry mouth, acid reflux, and bitter taste) that may accompany ulcers, and its cooling properties are not harsh, avoiding damage to the spleen and stomach. Lotus seed tonifies the spleen, stops diarrhea, and astringes: enhancing the spleen-strengthening effect, while also relieving loose stools that may accompany ulcers and protecting the gastrointestinal mucosa. Coix seed strengthens the spleen and eliminates dampness: assisting white hyacinth bean in removing dampness, improving the spleen and stomach's digestive function, and reducing the impact of dampness on ulcers. Licorice is used as the guiding herb; it is sweet and neutral in nature, entering the heart, lung, spleen, and stomach meridians. It tonifies the spleen and stomach qi and harmonizes the other herbs in the formula (such as mitigating the cooling nature of dandelion). Modern research also shows that its glycyrrhizic acid content has a certain protective effect on the gastric mucosa.

[0032] Meanwhile, this invention employs probiotic fermentation, which allows for the full release of the effective components of traditional Chinese medicine. It also generates various bioenzymes, promoting the decomposition and transformation of complex components in the medicinal materials, making them easier for the human body to absorb and utilize, thereby improving the absorption and utilization rate of the drug and enhancing its efficacy. Simultaneously, the decomposition of toxic components and the generation of metabolites during fermentation reduce the toxicity of the drug and improve its taste. Furthermore, this invention unexpectedly discovered that the resulting food-grade traditional Chinese medicine composition exhibits excellent stability. Attached Figure Description

[0033] The illustrative embodiments and descriptions of the present invention are used to explain the present invention and do not constitute an improper limitation of the present invention. Detailed Implementation

[0034] It should be noted that the following detailed descriptions are exemplary and intended to provide further illustration of the invention. Unless otherwise specified, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0035] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to the present invention. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0036] The following examples further illustrate the present invention, but do not constitute a limitation thereof. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0037] Example 1 A method for preparing a traditional Chinese medicine composition that is both food and medicine, wherein the active ingredients are as follows: 20 parts yam, 15 parts lotus seeds, 15 parts white hyacinth bean, 10 parts Buddha's hand, 10 parts dandelion, 15 parts coix seed, 8 parts jujube, 12 parts malt and 6 parts licorice.

[0038] The preparation method includes: S1. Select raw materials from the compound of medicinal and edible Chinese medicines, mix them, pulverize them, pass them through a 60-mesh sieve, and mix them again to obtain a fine powder of raw material mixture. S2. Add a 10% inoculum of compound probiotic powder consisting of *Lactobacillus plantarum* CICC 20317 and *Lactobacillus helveticus* CICC 6102 to the mixed fine powder of raw materials for fermentation to obtain fermented raw material; the compound probiotic powder is a combination of *Lactobacillus plantarum* CICC 20317 and *Lactobacillus helveticus* CICC 6102; before inoculation, the viable count of each probiotic in the compound probiotic powder is controlled at 2 billion CFU / g. The fermentation temperature is controlled at 30℃, and the fermentation humidity is controlled at 70%.

[0039] S3. Add water to the fermented raw material and decoct it, controlling the boiling time to 40 min; the material-to-liquid ratio is 1:10 (w / w), filter the liquid with gauze, concentrate and freeze dry to obtain freeze-dried powder.

[0040] Example 2 A method for preparing a traditional Chinese medicine composition that is both food and medicine, wherein the active ingredients are as follows: 22 parts yam, 14 parts lotus seeds, 12 parts white hyacinth bean, 8 parts Buddha's hand, 8 parts dandelion, 12 parts coix seed, 10 parts jujube, 10 parts malt and 5 parts licorice.

[0041] The preparation method is the same as in Example 1.

[0042] Example 3 A method for preparing a traditional Chinese medicine composition that is both food and medicine, wherein the active ingredients are as follows: 18 parts yam, 16 parts lotus seeds, 17 parts white hyacinth bean, 11 parts Buddha's hand, 11 parts dandelion, 16 parts coix seed, 6 parts jujube, 12 parts malt and 7 parts licorice.

[0043] The preparation method is the same as in Example 1.

[0044] Comparative Example 1 A method for preparing a traditional Chinese medicine composition that is both food and medicine, wherein the active ingredients are as follows: 20 parts yam, 15 parts lotus seeds, 15 parts white hyacinth bean, 10 parts Buddha's hand, 10 parts dandelion, 15 parts coix seed, 8 parts jujube, 12 parts malt and 6 parts licorice.

[0045] The preparation method includes: S1. Select raw materials from the compound of medicinal and edible Chinese medicines, mix them, pulverize them, pass them through a 60-mesh sieve, and mix them again to obtain a fine powder of raw material mixture. S2. Add water to the fine powder of the raw materials and decoct for 40 minutes. The ratio of raw material to liquid is 1:10 (w / w). Filter the liquid through gauze, concentrate and freeze dry to obtain freeze-dried powder.

[0046] Comparative Example 2 A method for preparing a traditional Chinese medicine composition that is both food and medicine, wherein the active ingredients are as follows: 25 parts yam, 10 parts lotus seeds, 10 parts white hyacinth bean, 10 parts Buddha's hand, 10 parts dandelion, 15 parts coix seed, 8 parts jujube, 12 parts malt and 6 parts licorice.

[0047] The preparation method is the same as in Example 1.

[0048] Comparative Example 3 A method for preparing a traditional Chinese medicine composition that is both food and medicine, wherein the active ingredients are as follows: 20 parts yam, 15 parts lotus seeds, 15 parts white hyacinth bean, 10 parts Buddha's hand, 10 parts dandelion, 15 parts coix seed, 8 parts jujube, 12 parts malt and 6 parts licorice.

[0049] The preparation method includes: S1. Select raw materials from the compound of medicinal and edible Chinese medicines, mix them, pulverize them, pass them through a 60-mesh sieve, and mix them again to obtain a fine powder of raw material mixture. S2. Add probiotic powder composed of *Lactobacillus plantarum* CICC 20317 (inoculation amount of 10%) to the raw material mixture and ferment to obtain fermented raw material; before inoculation, the viable count of *Lactobacillus plantarum* CICC 20317 is controlled at 2 billion CFU / g. The fermentation temperature is controlled at 30℃ and the fermentation humidity is controlled at 70%.

[0050] S3. Add water to the fermented raw material and decoct it, controlling the boiling time to 40 min; the material-to-liquid ratio is 1:10 (w / w), filter the liquid with gauze, concentrate and freeze dry to obtain freeze-dried powder.

[0051] Comparative Example 4 A method for preparing a traditional Chinese medicine composition that is both food and medicine, wherein the active ingredients are as follows: 20 parts yam, 15 parts lotus seeds, 15 parts white hyacinth bean, 10 parts Buddha's hand, 10 parts dandelion, 15 parts coix seed, 8 parts jujube, 12 parts malt and 6 parts licorice.

[0052] The preparation method includes: S1. Select raw materials from the compound of medicinal and edible Chinese medicines, mix them, pulverize them, pass them through a 60-mesh sieve, and mix them again to obtain a fine powder of raw material mixture. S2. Add probiotic powder composed of Lactobacillus helveticus CICC 6102 (inoculation amount of 10%) to the raw material mixture and ferment to obtain fermented raw material; before inoculation, the viable count of Lactobacillus helveticus CICC 6102 is controlled at 2 billion CFU / g. The fermentation temperature is controlled at 30℃ and the fermentation humidity is controlled at 70%.

[0053] S3. Add water to the fermented raw material and decoct it, controlling the boiling time to 40 min; the material-to-liquid ratio is 1:10 (w / w), filter the liquid with gauze, concentrate and freeze dry to obtain freeze-dried powder.

[0054] Effect verification: I. Pharmacodynamic Study of Probiotic Fermented and Unfermented Compositions on Cysteine ​​Hydrochloride-Induced Duodenal Ulcers Experimental samples: Samples 1-3 are freeze-dried powders prepared in Examples 1-3 respectively; Samples 4-7 are freeze-dried powders prepared in Comparative Examples 1-4 respectively.

[0055] Animals: All experimental animals were SPF-grade Sprague-Dawley rats, which were used to begin the experiment at 6-8 weeks of age. The rats were subjected to a 12-hour light-dark cycle.

[0056] Equipment: Electronic balances: ACS-JJ type, TIGE-1220 type, AUY220 type; Vernier calipers: 0-150mm; Shanghai Shenhan Measuring Tools Co., Ltd.

[0057] Reagents: Cysteine ​​hydrochloride: purchased from Solarbio, product number Lot. No. 20170218, stored at room temperature. 0.9% NaCl solution: Chenxin Pharmaceutical Co., Ltd., stored at room temperature.

[0058] Model establishment and grouping: Healthy SD rats and rats that have passed quarantine were selected. Except for the blank control group, the remaining animals were administered cysteine ​​hydrochloride solution by gavage to establish the model. After modeling, some rats were dissected to observe whether the model was successful. Rats with successful modeling were selected and grouped into groups of 8.

[0059] Drug preparation: Test sample 1: powder, stored at room temperature. The dosage for rats was 42.3 g / kg twice daily. The powder was dissolved in pure water to form a suspension, with a dosage volume of 15 ml / kg.

[0060] Administration method: On the second day of modeling, the corresponding drugs were administered to each group of animals via oral gavage. The model control group and the blank control group were given an equal volume of pure water. The drugs were administered continuously for 16 days, and the animals were dissected on the 17th day.

[0061] Testing indicators: Animals were euthanized with carbon dioxide. The abdominal cavity was incised along the midline below the xiphoid process of the sternum, and the stomach and duodenum were removed. The stomach cavity was cut along the greater curvature of the stomach. The duodenum was longitudinally dissected from the opposite side of the ulcer. After rinsing with 0.9% NaCl solution, the duodenum was placed on a grid of white paper and flattened. The long and short diameters of the ulcer at the duodenum were measured with vernier calipers, and the ulcer index and ulcer inhibition rate were calculated.

[0062] Ulcer index (U): U = U1 + U2 + U3 · 10 -1 The criteria for U1 lesion count, U2 lesion severity, and U3 ulcer area are as follows: U2 lesion severity is defined as follows: 0 = no obvious lesion, 1 = mucosal surface redness and swelling, 2 = superficial ulcer, 3 = penetrating ulcer. U3 ulcer area is defined as follows: Ulcer area = major diameter × minor diameter (mm) 2 ).

[0063] x 100% result: 1. Statistics of rat ulcer index: As shown in Table 1, all rats in each group were compared with the model group. It was found that the ulcer index of test products 1-3 and test product 6 was significantly lower than that of the model group, while the ulcer index of test products 4-5 decreased less.

[0064] Table 1. Statistics of Ulcer Index in Rats

[0065] 2. Inhibition rate of different drugs on rat ulcers Table 2 shows the ulcer inhibition rate of each treatment group compared to the model group. Test sample 1 showed the most significant inhibition rate at 61.88%, while test samples 4-5 exhibited poorer ulcer inhibition rates.

[0066] Table 2. Statistics on Ulcer Inhibition Rate

[0067] II. Product Storage Stability Test The freeze-dried powders obtained in Examples 1-3 and Comparative Examples 1-4 of this invention were individually packaged in aluminum foil bags and stored under accelerated conditions (temperature: 45°C; relative humidity: 75%). After 30 days of storage, the samples were taken out and the product properties were observed to evaluate the storage stability of the products. The results are shown in Table 3.

[0068] Table 3. Storage stability test results

[0069] As shown in Table 3, the combination of each component in this invention with probiotics can effectively alleviate the sticking and clumping of freeze-dried powder and improve the storage stability of the product.

[0070] Typical cases Case 1 Ms. Yu, a 30-year-old office worker, experienced recurrent burning pain in her upper abdomen on an empty stomach, accompanied by acid reflux and fatigue, due to long-term overtime work, irregular eating habits, and significant emotional stress over the past two months. She was diagnosed with a duodenal ulcer. After taking the lyophilized powder from Example 1 for 10 days, the frequency of her upper abdominal pain significantly decreased, and her acid reflux was relieved. After continuing to take it for 25 days, the pain basically disappeared, and her appetite returned. A follow-up gastroscopy one month later showed that the ulcer had completely healed.

[0071] Case 2 Mr. Zhang, male, 42 years old, a driver, suffered from duodenal ulcers for more than 5 years due to irregular eating habits and high stress caused by his job. The ulcers recurred repeatedly, manifesting as upper abdominal pain two hours after meals, nausea, and weight loss. After taking the lyophilized powder from Example 1 for 15 days, the intervals between abdominal pain attacks lengthened, and the nausea disappeared. After continuing to take it for 40 days, the abdominal pain did not recur, and his weight returned. A follow-up examination two months later showed that the ulcer had completely healed, and there was no recurrence during a one-year follow-up.

[0072] Case 3 Ms. Wang, a 28-year-old female teacher, experienced prolonged anxiety and high teaching pressure at work, resulting in nocturnal upper abdominal cramps, diarrhea, and a sallow complexion for the past three months. She was diagnosed with a duodenal ulcer. After taking the lyophilized powder from Example 1 for seven days, her nocturnal abdominal pain subsided and her diarrhea stopped. After continuing to take it for 20 days, all symptoms disappeared, and her complexion returned to a rosy state. A follow-up examination one month later showed that the ulcer had healed, and a six-month follow-up showed no abnormalities.

[0073] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A probiotic fermented medicinal and edible traditional Chinese medicine composition, characterized in that, The medicinal and edible Chinese medicine composition comprises the following components: Shanyao, lotus seeds, white beans, bergamot, dandelion, yiyi- ren, jujube, malt and licorice. 2.The medicinal and edible traditional Chinese medicine composition of claim 1, characterized in that, The Chinese medicine composition comprises the following components in parts by weight: Shanyao 18-23 parts, lotus seeds 12-17 parts, white beans 12-17 parts, bergamot 7-12 parts, dandelion 7-12 parts, yiyi- ren 12-17 parts, jujube 5-10 parts, malt 10-15 parts and licorice 3-8 parts. 3.The medicinal and edible traditional Chinese medicine composition of claim 1, characterized in that, The Chinese medicine composition comprises the following components in parts by weight: Shanyao 20-22 parts, lotus seeds 14-16 parts, white beans 14-16 parts, bergamot 8-11 parts, dandelion 8-11 parts, yiyi- ren 13-16 parts, jujube 6-9 parts, malt 11-14 parts and licorice 5-6 parts. 4.The TCM composition of claim 1, wherein, The Chinese medicine composition comprises the following components in parts by weight: Shanyao 20 parts, lotus seeds 15 parts, white beans 15 parts, bergamot 10 parts, dandelion 10 parts, yiyi- ren 15 parts, jujube 8 parts, malt 12 parts and licorice 6 parts.

5. The medicinal and edible traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The Chinese medicine composition is fermented by probiotics, which include but are not limited to lactobacillus or streptococcus, the lactobacillus includes lactobacillus acidophilus, lactobacillus gasseri, lactobacillus plantarum, lactobacillus helveticus, lactobacillus salivarius, lactobacillus fermentum, lactobacillus delbrueckii subsp. bulgaricus; the streptococcus includes streptococcus salivarius subsp. thermophilus; further, the probiotics are a combination of lactobacillus plantarum CICC 20317 and lactobacillus helveticus CICC 6102.

6. The method for preparing the composition of the medicinal and edible traditional Chinese medicine according to any one of claims 1-5, characterized in that, The preparation method comprises: S1, selecting the raw materials of the medicinal and edible Chinese medicine compound, crushing, sieving and mixing again to obtain the fine powder of the raw materials; S2, adding probiotics to the fine powder of the raw materials for fermentation to obtain fermented raw materials; S3, decocting the fermented raw materials to obtain medicinal liquid, and then concentrating and freeze-drying to obtain freeze-dried powder.

7. The preparation method of claim 6, wherein In step S1, the mesh size is 50-80 mesh; In step S2, the probiotics are preferably a combination of lactobacillus plantarum CICC 20317 and lactobacillus helveticus CICC 6102, and the CFU ratio of lactobacillus plantarum CICC 20317 to lactobacillus helveticus CICC 6102 in the combination is 0.5-5:1; In step S3, the fermented raw materials are decocted with water, the boiling time is controlled for 20-40 min, the solid-liquid ratio is 1:8-10 (w / w), and the medicinal liquid is obtained by filtering through gauze.

8. The production method according to claim 6, wherein In step S2, the fermentation temperature is controlled at 30-38℃, the humidity is controlled at 70-80%, and the fermentation time is controlled at 24-48 h; The addition amount of probiotics in the fine powder of raw materials is controlled at 8-15%, preferably 10%.

9. Use of the medicinal and edible composition of any one of claims 1-5 in the preparation of a product for chronic diseases.

10. The use according to claim 9, wherein the compound is ###0002### The product includes but is not limited to food and medicine; The chronic diseases include gastrointestinal diseases, cardiovascular diseases and diabetes, and the gastrointestinal diseases are preferred; further, the diseases are gastric duodenal ulcer.

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