Medicine-food homologous composition based on principles of promoting qi, activating blood circulation, and detoxifying, and preparation method therefor and use thereof

Abstract

The present disclosure relates to the technical field of compositions. Disclosed are a medicine-food homologous composition based on the principles of promoting Qi, activating blood circulation, and detoxifying, and a preparation method therefor and a use thereof. The present disclosure specifically relates to the medicine-food homologous composition, prepared from the following active ingredients in parts by weight: 3-13 parts of ginseng, 5-15 parts of phyllanthus emblica, 5-15 parts of raw coix seeds, 1-12 parts of citron, 1-12 parts of Hua Ju Hong, and 10-25 parts of dandelion. In the present disclosure, on the basis of "the principles of promoting Qi, activating blood circulation, and detoxifying", medicine-food homologous plants are used as raw materials to prepare the medicine-food homologous composition. The medicine-food homologous composition is capable of regulating Qi (promoting Qi and tonifying Qi), activating blood circulation and resolving stasis, and clearing heat and detoxifying, which essentially covers key pathomechanisms and associated syndrome‑element targets of chronic atrophic gastritis (CAG), and thus the medicine-food homologous composition can assist in treating CAG, intestinal metaplasia, and low‑grade intraepithelial neoplasia, preventing precancerous gastric lesions, and relieving gastric mucosal injury. Compared with the prior art, the present disclosure has minimal toxic side effects, high acceptability, and suitability for long-term administration.

Description

A medicinal and edible homologous composition based on the method of regulating qi, promoting blood circulation, and detoxifying, and its preparation method and application.

[0001] Relevant publicly available cross-references

[0002] This disclosure claims priority to Chinese Patent Application No. 202411819190.X, filed on December 11, 2024, entitled "A medicinal and edible composition based on the method of regulating qi, activating blood circulation, and detoxifying, and its preparation method and application", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure belongs to the field of composition technology, specifically relating to a medicinal and edible composition based on the method of regulating qi, promoting blood circulation, and detoxifying, as well as its preparation method and application. Background Technology

[0004] Precancerous lesions of gastric cancer (PLGC) refer to intestinal metaplasia and / or intraepithelial neoplasia occurring on the basis of chronic atrophic gastritis. It is a common and frequently occurring disease in clinical gastroenterology. PLGC is an important precursor lesion to gastric cancer, and timely intervention and treatment can significantly reduce the incidence of gastric cancer.

[0005] Domestic and international guidelines generally recommend a regular diet for patients with precancerous lesions of the stomach, including plenty of fresh vegetables and fruits, high-quality protein, a light and low-salt diet, and avoiding or minimizing pickled, smoked, and fried foods. Supplementation with folic acid, vitamin C, beta-carotene, and nonsteroidal anti-inflammatory drugs (NSAIDs) may be considered as methods to prevent stomach cancer in patients with chronic atrophic gastritis (CAG), but this remains controversial.

[0006] Currently, there are no Chinese or Western medicines on the market with relatively clear targets for *H. pylori*-related chronic atrophic gastritis (CAG) and precancerous lesions of the stomach, nor are there any products targeting *H. pylori*-related chronic atrophic gastritis precancerous lesions. Therefore, developing new prevention and treatment strategies to slow the progression of stomach cancer, block the transformation from gastric inflammation to cancer, and shift from treating stomach cancer to preventing its occurrence—a shift from "treatment" to "prevention"—has significant public health implications.

[0007] Numerous studies have been conducted on the treatment of precancerous lesions of the stomach using traditional Chinese medicine, such as CN117045762A, CN117281880A, CN112107668A, and CN110193073A. However, patients with precancerous lesions generally require long-term oral medication, which has low patient acceptance and poses certain safety risks. Therefore, it is highly necessary to develop a medicinal and edible homologous composition with fewer side effects, higher acceptance, and therapeutic benefits. Summary of the Invention

[0008] To address the problems existing in the prior art, this disclosure provides a medicinal and edible homologous composition based on the method of regulating qi, activating blood circulation, and detoxifying, as well as its preparation method and application.

[0009] Precancerous lesions of the stomach fall under the category of "gastric fullness and distension." The inventors' team extended gastroscopy as an extension of traditional Chinese medicine's diagnostic method of observation, proposing to use the appearance of gastric images as an indicator for monitoring the evolution of precancerous lesions of the stomach in chronic atrophic gastritis-intestinal metaplasia-intraepithelial neoplasia. In the early stages of the disease, external pathogens such as Helicobacter pylori (Hp) invade the body, and pathological products such as food stagnation, damp-heat, and phlegm accumulate in the middle jiao (spleen and stomach), causing stagnation of qi and blood, leading to the formation of disease. This results in redness and edema of the gastric mucosa, with a large amount of stagnant white, turbid mucus. At this stage, the pathogenic factors are at their peak, representing a stage of fullness and distension. After eradicating Hp, the cause is eliminated, and the pathogenic heat gradually subsides. However, the heat depletes qi and damages yin, consuming body fluids and blood, and the toxic pathogens become entangled and difficult to resolve. The gastric image shows map-like redness, and the gastric fundic gland mucosa becomes white and visible. Based on the different endoscopic manifestations during the "inflammation-cancer" transformation process and extensive clinical and basic research, they proposed the pathogenesis of Hp-related chronic atrophic gastritis precancerous lesions as "heat generating toxins." Our team's previous clinical symptom investigation revealed that the pathogenesis of chronic atrophic gastritis (CAG) with intestinal metaplasia (IM) is mainly characterized by deficiency of the root and excess of the branch. The root deficiency is primarily due to spleen and stomach weakness, while the branch excess manifests as qi stagnation, dampness obstruction, heat stagnation, food accumulation, and blood stasis. Therefore, regulating qi (tonifying qi), promoting blood circulation and removing blood stasis, and clearing heat and detoxifying can basically cover the key pathogenesis and related syndrome elements of CAG. Based on this, the inventors' team proposed the "qi-regulating, blood-activating, and detoxifying method" for treating precancerous lesions of Hp-related chronic atrophic gastritis. Through screening and compounding of medicinal and edible homologous raw materials, we obtained the medicinal and edible homologous composition disclosed in this publication, which has the advantages of regulating qi, activating blood circulation, and detoxifying. Products prepared using the above-mentioned medicinal and edible homologous composition have advantages such as fewer side effects, higher acceptability, and therapeutic effects, meeting clinical needs.

[0010] To achieve the above objectives, the technical solution adopted in this disclosure is as follows:

[0011] In a first aspect, this disclosure provides a medicinal and edible composition, which, by weight, is made from the following raw materials: 3-13 parts ginseng, 5-15 parts amla, 5-15 parts raw coix seed, 1-12 parts citron, 1-12 parts tangerine peel and 10-25 parts dandelion.

[0012] Preferably, the medicinal and edible composition is made from the following raw materials in parts by weight: 7-11 parts ginseng, 7-11 parts amla, 8-12 parts raw coix seed, 3-9 parts citron, 3-9 parts tangerine peel, and 10-20 parts dandelion.

[0013] More preferably, the medicinal and edible composition is made from the following raw materials in parts by weight: 9 parts ginseng, 9 parts amla, 10 parts raw coix seed, 6 parts citron, 6 parts tangerine peel, and 15 parts dandelion.

[0014] In some embodiments, the weight ratio of ginseng, amla, and raw coix seed is 7-11:7-11:8-12; preferably 9:9:10.

[0015] Secondly, this disclosure provides a method for preparing the aforementioned food-medicine homology composition, comprising the following steps:

[0016] Ginseng, Phyllanthus emblica, raw Coix seed, Citrus medica, Citrus reticulata peel, and Taraxacum mongolicum were extracted with water, and then subjected to solid-liquid separation, concentration, and drying to obtain the aforementioned food-medicine homologous composition.

[0017] Preferably, the amount of water added in the water extract is 5-10 times the total amount of ginseng, amla, raw coix seed, citron, tangerine peel and dandelion.

[0018] More preferably, the water extraction temperature is 70-90℃ and the time is 60-90 minutes.

[0019] Preferably, the solid-liquid separation includes centrifugation and filtration.

[0020] Preferably, the concentration is vacuum concentration, with a concentration temperature of 70-80℃ and a vacuum degree of 0.07-0.01 MPa.

[0021] More preferably, the concentration is to 15-35% of the original concentrated liquid volume, even more preferably 18-30%; and more preferably 20-30%.

[0022] Preferably, the drying is freeze drying and / or spray drying, more preferably spray drying.

[0023] Specifically, the inlet air temperature of the spray dryer is 150-160℃, and the outlet air temperature is 95-105℃.

[0024] Thirdly, this disclosure provides the application of the above-mentioned food and medicine homology composition in the preparation of products that improve Helicobacter pylori infection-related diseases.

[0025] In some embodiments, the application is the use of the above-mentioned food-medicine homology composition in the preparation of drugs to improve precancerous lesions of the stomach.

[0026] Preferably, the precancerous lesions of the stomach include at least one of chronic atrophic gastritis, intestinal metaplasia, and low-grade intraepithelial neoplasia.

[0027] In some embodiments, the application is the use of the above-mentioned food-medicine homology composition in the preparation of food that improves gastric mucosal damage.

[0028] Fourthly, this disclosure provides a food-medicine homology product, comprising the above-mentioned food-medicine homology composition and acceptable excipients.

[0029] The acceptable excipients described in this disclosure are food-acceptable excipients or pharmaceutically acceptable excipients.

[0030] Preferably, the acceptable excipients include at least one of fillers, sweeteners, acidulants, and anti-caking agents.

[0031] More preferably, the filler is maltodextrin and / or starch; the sweetener is at least one of xylitol, sucralose, and erythritol; the acidulant is citric acid and / or malic acid; and the anti-caking agent is silicon dioxide and / or microcrystalline cellulose.

[0032] Fifthly, this disclosure provides a solid beverage that is both food and medicine, comprising the above-mentioned food and medicine composition, filler, sweetener, fruit powder, and anti-caking agent.

[0033] Preferably, the medicinal and edible solid beverage is made from the following raw materials in parts by weight: 3-13 parts ginseng, 5-15 parts amla, 5-15 parts raw coix seed, 1-12 parts citron, 1-12 parts tangerine peel, 10-25 parts dandelion, 10-14 parts filler, 6-8 parts sweetener, 1-5 parts fruit powder, and 3-7 parts anti-caking agent.

[0034] More preferably, the medicinal and edible solid beverage is made from the following raw materials in parts by weight: 3-13 parts ginseng, 5-15 parts amla, 5-15 parts raw coix seed, 1-12 parts citron, 1-12 parts tangerine peel, 10-25 parts dandelion, 10-14 parts maltodextrin, 6-8 parts xylitol, and 3-7 parts silicon dioxide.

[0035] More preferably, the medicinal and edible solid beverage is made from the following raw materials by weight: 9 parts ginseng, 9 parts amla, 10 parts raw coix seed, 6 parts citron, 6 parts tangerine peel, 15 parts dandelion, 10-14 parts maltodextrin, 6-8 parts xylitol and 3-7 parts silicon dioxide.

[0036] In some embodiments, the preparation method of the medicinal and edible solid beverage is as follows: the medicinal and edible composition and excipients are mixed, and then packaged.

[0037] Compared with the prior art, this disclosure has the following beneficial effects:

[0038] (1) Based on the “Qi-regulating, blood-activating and detoxifying method”, the inventors prepared the food-medicine homology composition disclosed herein using food-medicine homology plants as raw materials. The food-medicine homology composition basically covers the pathogenesis points and related syndrome elements of CAG by regulating Qi (regulating Qi, tonifying Qi), activating blood and removing blood stasis, clearing heat and detoxifying. It can assist in the treatment of chronic atrophic gastritis, intestinal metaplasia and low-grade intraepithelial neoplasia, prevent precancerous lesions of gastric cancer, and assist in improving gastric mucosal damage.

[0039] (2) Compared with the prior art, the raw materials disclosed herein are all medicinal and edible plants, with less toxic side effects, better safety, and suitable for long-term use.

[0040] (3) Compared with traditional Chinese medicine, the food-medicine homology products prepared using this disclosure have a better taste and are more acceptable to patients.

[0041] (4) This disclosure not only preserves the nutritional and pharmacological effects of traditional medicinal materials, but also optimizes them in modern food processing, making them convenient for consumers to drink daily. They have the effects of enhancing immunity, anti-fatigue, anti-oxidation, and promoting digestion.

[0042] (5) The preparation method disclosed herein is simple and the prepared product has good stability. Attached Figure Description

[0043] Figure 1 shows the comparison of gastric tissue morphology under microscope (HE staining) of rats in each group. a1, b1, c1, d1, e1, and f1 are HE stained, ×200; a2, b2, c2, d2, e2, and f2 are HE stained, ×400.

[0044] Figure 2 shows the statistical chart of gastric atrophy scores of rats in each group. Among the groups, *p<0.05, **p<0.01, ***p<0.001, ****p<0.0001, and nsp>0.05.

[0045] Figure 3 shows the statistical chart of intestinal metaplasia scores of rats in each group. Among the groups, *p<0.05, **p<0.01, ***p<0.001, ****p<0.0001, and nsp>0.05.

[0046] Figure 4 shows the statistical chart of low-grade intraepithelial neoplasia scores in each group of rats. Among the groups, *p<0.05, **p<0.01, ***p<0.001, ****p<0.0001, and nsp>0.05. Detailed Implementation

[0047] The present disclosure will be described below through specific embodiments to make the technical solutions of the present disclosure easier to understand and master. However, the present disclosure is not limited thereto. The described embodiments are only some embodiments of the present disclosure, and not all embodiments.

[0048] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, which should be understood to include values ​​close to them. For numerical ranges, one or more new numerical ranges can be obtained by combining the endpoint values ​​of the ranges, the endpoint values ​​of the ranges with individual point values, and individual point values ​​with each other, and these numerical ranges should be considered as specifically disclosed herein. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein include both singular and plural indicators. Numerical ranges expressed by endpoints include all numerical values ​​and fractions within the corresponding range, as well as the expressed endpoints.

[0049] Based on the embodiments in this disclosure, all other embodiments obtained by those skilled in the art without inventive effort should fall within the scope of protection of this disclosure. Unless otherwise specified, the experimental methods described in the following embodiments are conventional methods. Unless otherwise specified, the reagents and materials are commercially available; the following reagent source information is illustrative and should not be construed as limiting this disclosure.

[0050] [Qi-regulating, blood-activating, and detoxifying method - a combination of medicinal and edible ingredients]

[0051] Example 1: A Composition of Food and Medicine

[0052] The components of the food-medicine homology composition in Example 1 are shown in Table 1.

[0053] Table 1. Composition of Food-Medicine Homologous Compositions

[0054] Based on the formulation in Table 1, prepare the food-medicine homology composition according to the following steps.

[0055] Step 1: Clean, remove impurities, and cut the plant materials such as ginseng, amla, raw coix seed, citron, tangerine peel, and dandelion (0.5mm) into pieces, and dry them at 55℃ until the moisture content does not exceed 5%.

[0056] Step 2: Weigh the plant materials according to the formula, add 8 times the amount of water, extract at 80℃ for 80 minutes, filter, and obtain a clear liquid.

[0057] Step 3: Concentrate the clear liquid at 80℃ and 0.08MPa vacuum for 30 minutes, until it reaches 25-30% of the original clear liquid volume, to obtain the concentrated liquid.

[0058] Step 4: Spray dry the concentrate, set the inlet air temperature to 160℃ and the outlet air temperature to 95℃ to obtain a food-medicine homology composition.

[0059] Example 2: Food and Medicine Homologous Composition

[0060] The components of the food-medicine homology composition in Example 2 are shown in Table 2.

[0061] Table 2. Composition of Food-Medicine Homologous Compositions

[0062] Based on the formulation in Table 2, prepare the food-medicine homology composition according to the following steps.

[0063] Step 1: Clean, remove impurities, and cut the plant materials such as ginseng, amla, raw coix seed, citron, tangerine peel, and dandelion (0.5mm) into pieces, and dry them at 55℃ until the moisture content does not exceed 5%.

[0064] Step 2: Weigh the plant materials according to the formula, add 5 times the amount of water, extract at 70℃ for 90 minutes, filter, and obtain a clear liquid.

[0065] Step 3: Concentrate the clear liquid at 80℃ and 0.08MPa vacuum for 30 minutes, until it reaches 25-30% of the original clear liquid volume, to obtain the concentrated liquid.

[0066] Step 4: Spray dry the concentrate, set the inlet air temperature to 160℃ and the outlet air temperature to 95℃ to obtain a food-medicine homology composition.

[0067] Example 3: Food and Medicine Homologous Composition

[0068] The components of the food-medicine homology composition in Example 3 are shown in Table 3.

[0069] Table 3. Composition of Food-Medicine Homologous Compositions

[0070] Based on the formulation in Table 3, prepare the food-medicine homology composition according to the following steps.

[0071] Step 1: Clean, remove impurities, and cut the plant materials such as ginseng, amla, raw coix seed, citron, tangerine peel, and dandelion (0.5mm) into pieces, and dry them at 55℃ until the moisture content does not exceed 5%.

[0072] Step 2: Weigh the plant materials according to the formula, add 10 times the amount of water, extract at 90℃ for 60 minutes, filter, and obtain a clear liquid.

[0073] Step 3: Concentrate the clear liquid at 80℃ and 0.08MPa vacuum for 30 minutes, until it reaches 25-30% of the original clear liquid volume, to obtain the concentrated liquid.

[0074] Step 4: Spray dry the concentrate, set the inlet air temperature to 160℃ and the outlet air temperature to 95℃ to obtain a food-medicine homology composition.

[0075] Comparative Example 1: Food and Medicine Homologous Composition

[0076] The composition of the food-medicine homology composition in Comparative Example 1 is shown in Table 4. The only difference between Comparative Example 1 and Example 1 is the weight ratio of ginseng, amla, and raw coix seed.

[0077] Table 4. Composition of Food-Medicine Homologous Compositions

[0078] The preparation method is the same as in Example 1.

[0079] Comparative Example 2: Food and Medicine Homologous Composition

[0080] The composition of the food-medicine homology composition in Comparative Example 2 is shown in Table 5. The only difference from Example 1 is that citron and tangerine peel are replaced with houttuynia cordata and poria cocos, respectively.

[0081] Table 5. Composition of Food-Medicine Homologous Compositions

[0082] The preparation method is basically the same as in Example 1.

[0083] Comparative Example 3: Food and Medicine Homologous Composition

[0084] The composition of the food-medicine homology composition in Comparative Example 3 is shown in Table 6. The difference between Comparative Example 3 and Example 1 is the difference in the amount of citron, tangerine peel and dandelion raw materials.

[0085] Table 6. Composition of Food-Medicine Homologous Compositions

[0086] The preparation method is the same as in Example 1.

[0087] I. Animal Experiment Verification

[0088] 1. Materials

[0089] 1.1 Main drugs

[0090] Main drugs: N-methyl-N-nitro-nitrosoguanidine (MNNG) (batch number M0527): Tokyo Chemical Industry Co., Ltd.; Sodium salicylate (batch number 30169317): Sinopharm Chemical Reagent Co., Ltd.; Ranitidine hydrochloride capsules (national drug approval number H32025308): Hongsen Pharmaceutical Co., Ltd.; Sodium pentobarbital (batch number P11011): Merck AG, Germany;

[0091] Test substances: the food-medicine homologous composition prepared by the method of regulating qi, activating blood circulation and detoxifying in Example 1, and the food-medicine homologous compositions prepared by Comparative Examples 1-3, were uniformly dispensed by the Granule Pharmacy of Dongzhimen Hospital of Beijing University of Chinese Medicine.

[0092] 1.2 Main Instruments

[0093] JB-P5 Embedding Machine: Wuhan Junjie Electronics Co., Ltd.; RM2016 Pathological Microtome: Shanghai Leica Instruments Co., Ltd.; KD-P Tissue Spreader: Zhejiang Jinhua Cody Instrument and Equipment Co., Ltd.; DHG-9140A Oven: Shanghai Huita Instrument Manufacturing Co., Ltd.; NIKON ECLIPSE CI Inverted Fluorescence Microscope: Nikon, Japan; Pannoramic MIDI Scanner: 3DHISTECH.

[0094] 1.3 Animals

[0095] 60 SPF-grade male Wistar rats at 3 weeks of age were purchased from Beijing Speifo (Beijing) Biotechnology Co., Ltd., with the experimental animal production license number SCXK (Beijing) 2019-0010. They were housed in the SPF-grade scientific research experimental center of Beijing University of Chinese Medicine, at a temperature of (23±3) °C and a relative humidity of 40% - 60%, with a 12-hour light-dark cycle. During the feeding period, they had free access to food and water. After 1 week of adaptive feeding, the experiment was conducted.

[0096] 1.4 Ethical Review

[0097] This experiment was approved by the Experimental Animal Ethics Sub-committee of the Academic Committee of Beijing University of Chinese Medicine, with the ethical number: BUCM-2023022303-1151.

[0098] 2. Methods

[0099] 2.1 Establishment of Animal Model

[0100] The PLGC rat model was established using the MNNG multi-factor method for 24 weeks: Rats were allowed to freely drink a 120 μg / mL MNNG + 0.9% normal saline solution (the concentration of the MNNG stock solution was 1 g / L, stored in the dark at 4 °C, freshly prepared before use to ensure the dissolution of sodium chloride, and there was no other drinking water during the period, replaced every 24 - 48 hours), and were allowed to freely eat SPF-grade pellet feed containing 0.05% ranitidine (no other food during the period); at the same time, the rats were subjected to irregular feeding, that is, fasting on Tuesdays and Fridays (and after fasting on the same day, intragastrically administered a 2% sodium salicylate solution at a dose of 5 mL / kg), and fed normally on Mondays, Wednesdays, Thursdays, Saturdays, and Sundays; the criteria for successful establishment of the model were that pathological histological examination showed atrophy, intestinal metaplasia, or low-grade intraepithelial neoplasia in the gastric mucosa of the rats. The quantification scores of atrophy, intestinal metaplasia, and low-grade intraepithelial neoplasia were referred to the "Consensus on the Integrated Chinese and Western Medicine Diagnosis and Treatment of Chronic Atrophic Gastritis (2017)" and the "Expert Consensus on the Management Strategies for Premalignant States and Premalignant Lesions of Gastric Mucosa in China (2020)".

[0101] 2.2 Animal Grouping and Drug Administration

[0102] Sixty rats were divided into four groups: normal group, model group, example group, comparative example 1 group, comparative example 2 group, and comparative example 3 group, with 10 rats in each group. After successful rat model replication, the rats were administered the test substance. The group receiving the Qi-regulating, blood-activating, and detoxifying herbal formula (Example 1) was administered the herbal formula solution daily via gavage at a dose of 2.4 g / kg body weight (prepared to a 200 μL gavage volume with sterile water). The groups receiving comparative examples 1-3 were administered the corresponding herbal formula solution daily via gavage at a dose of 2.4 g / kg body weight (prepared to a 200 μL gavage volume with sterile water). The intervention lasted for 9 weeks. During the administration period, rats in the model group and all administered groups continued to have free access to MNNG solution and continued to consume ranitidine-containing feed, while rats in the normal group had a normal diet.

[0103] 2.3 HE staining method

[0104] To observe the morphology of the gastric mucosa tissue of rats, rats were anesthetized and sacrificed by intramuscular injection of 2% sodium pentobarbital at 40 mg / kg the day after the end of treatment. Their gastric tissue was dissected and the gastric mucosa of each group of rats was observed by HE staining.

[0105] 2.4 Statistical Methods

[0106] All data were analyzed statistically using software. One-way ANOVA was used for comparisons of means across multiple groups. For comparisons between groups, an independent samples t-test was used between groups that were normally distributed and had homogeneous variances; for groups that were not normally distributed or had unequal variances, the nonparametric rank-sum test was used. A p-value < 0.05 was considered statistically significant.

[0107] 3. Results

[0108] As shown in Figure 1, the morphology of gastric tissue in each group of rats was compared as follows: In the normal group, the gastric mucosal glands of rats were tightly and neatly arranged, with regular gland arrangement and no pathological changes such as gastric mucosal atrophy or intestinal metaplasia were observed; in the model group, the gastric mucosal epithelial glands of rats were disordered, with epithelial cells of varying sizes and shapes, large and deeply stained nuclei, and a large number of goblet cells, showing obvious cellular atypia; in the example group, the gastric mucosal glands of rats were disordered, with no mucosal atrophy, intestinal metaplasia, or obvious cellular atypia observed; in the comparative example 1 group, the glands were disordered, with cells of varying sizes and shapes, large and deeply stained nuclei, and some goblet cells, showing relatively obvious atypia; in the comparative example 2 group, the gastric mucosal glands of rats were relatively disordered, with significant gland atrophy and loss, and goblet cells were visible, with atypical cells visible in the gastric mucosal epithelium; in the comparative example 3 group, the gastric mucosal glands of rats were disordered, with gastric mucosal epithelial cells of varying sizes and shapes, significant gland atrophy, and a large number of goblet cells and atypical cells. According to the standards in the guidelines, gastric mucosal atrophy, intestinal metaplasia, and low-grade intraepithelial neoplasia were visually scored and plotted as bar charts, as shown in Figures 2-4. Compared with the model group, the atrophy score, intestinal metaplasia score, and low-grade intraepithelial neoplasia score of the example group were significantly reduced (p < 0.0001). This indicates that the food-medicine homologous composition of the Qi-regulating, blood-activating, and detoxifying method provided in this disclosure has the efficacy of treating chronic atrophic gastritis, intestinal metaplasia, and low-grade intraepithelial neoplasia, and can prevent precancerous lesions of the stomach and help improve gastric mucosal damage. Compared with the model group, there were no significant changes in the atrophy score, intestinal metaplasia score, and low-grade intraepithelial neoplasia score of Comparative Examples 1-3 (p > 0.05). This indicates that the food-medicine homologous composition provided in the comparative examples of this disclosure does not have the efficacy of treating chronic atrophic gastritis, intestinal metaplasia, and low-grade intraepithelial neoplasia.

[0109] II. Clinical efficacy observation

[0110] The clinical efficacy of the food-medicine homology composition provided in Example 1 was observed through a self-controlled pre- and post-controlled trial. Forty patients who visited the Department of Gastroenterology at Dongzhimen Hospital of Beijing University of Chinese Medicine between November 15, 2024 and December 1, 2024, and were diagnosed by gastroscopy and pathology with CAG or CAG with intestinal metaplasia or low-grade intraepithelial neoplasia and met the inclusion criteria, were selected as the study subjects.

[0111] Before intervention, basic patient information was collected, including age, gender, occupation, disease course, past medical history, family history, and information from the four diagnostic methods of Traditional Chinese Medicine (inspection, auscultation and olfaction, inquiry, and palpation). A Traditional Chinese Medicine symptom scale was used to assess the severity and frequency of clinical symptoms, including stomach pain, bloating, acid reflux, belching, poor appetite, and fatigue. Intervention was initiated with a Qi-regulating, blood-activating, and detoxifying herbal food-based product for two weeks. After two weeks of intervention, the Traditional Chinese Medicine symptom scale was completed again to evaluate the clinical efficacy of the Qi-regulating, blood-activating, and detoxifying herbal food-based formula in treating the disease. Simultaneously, a market research questionnaire was completed to understand patient acceptance, satisfaction, and adverse reactions. Basic patient information, information from the four diagnostic methods of Traditional Chinese Medicine, Traditional Chinese Medicine symptom scale scores, and market research questionnaire results were collected in paper form. Count data were statistically analyzed using frequency distributions, or chi-square tests or Fisher's exact tests were used. For continuous data that are normally distributed and have homogeneous variances, an independent samples t-test is used between two groups. For data that are not normally distributed or have unequal variances, a nonparametric rank-sum test is used. A p-value < 0.05 is considered statistically significant.

[0112] Experimental completion status and baseline characteristics:

[0113] Of the initial 40 patients enrolled, 2 dropped out during the study: one was lost to follow-up after initial diagnosis, and the other withdrew due to irregular medication use caused by work commitments. Therefore, this study included 38 patients. There were 12 males and 26 females, with a mean age of 43 years. 34 patients had a history of *H. pylori* infection. The mean score for major symptoms before treatment was 3±2.536, and the mean score after treatment was 1.82±1.799; the mean score for minor symptoms before treatment was 8.63±5.299, and the mean score after treatment was 6.26±4.446.

[0114] Table 7. Traditional Chinese Medicine Syndrome Scoring Table

[0115] [Solid beverages that are both food and medicine]

[0116] Example 4: Solid Beverage with Medicinal and Edible Properties

[0117] The medicinal and edible solid beverage is composed of the following ingredients:

[0118] 3 parts ginseng, 5 parts amla, 5 parts raw coix seed, 1 part citron, 1 part tangerine peel, 10 parts dandelion, 10 parts maltodextrin, 6 parts xylitol, and 3 parts silicon dioxide.

[0119] The preparation method is as follows:

[0120] Step 1: Clean, remove impurities, and cut the plant materials such as ginseng, amla, raw coix seed, citron, tangerine peel, and dandelion (0.5mm) into pieces, and dry them at 55℃ until the moisture content does not exceed 5%.

[0121] Step 2: Weigh the plant materials according to the formula, add 10 times the amount of water, extract at 90℃ for 60 minutes, filter, and obtain a clear liquid.

[0122] Step 3: Concentrate the clear liquid at 80℃ and 0.08MPa vacuum for 30 minutes, until it reaches 25-30% of the original clear liquid volume, to obtain the concentrated liquid.

[0123] Step 4: Spray dry the concentrate, set the inlet air temperature to 160℃ and the outlet air temperature to 95℃ to obtain a food-medicine homology composition.

[0124] Step 5: Add the prescribed amounts of maltodextrin and xylitol to the food-medicine homology composition, mix well, add silicon dioxide, mix well again, dispense, and package to obtain a solid beverage.

[0125] Example 5: Solid Beverage with Medicinal and Edible Properties

[0126] The medicinal and edible solid beverage is composed of the following ingredients:

[0127] Ginseng 13 parts, Phyllanthus emblica 15 parts, raw Coix seed 12 parts, Citron 12 parts, Citrus reticulata peel 12 parts, dandelion 25 parts, maltodextrin 14 parts, xylitol 8 parts, and silicon dioxide 7 parts.

[0128] The preparation method is the same as in Example 4.

[0129] Example 6: Solid Beverage with Medicinal and Edible Properties

[0130] The medicinal and edible solid beverage is composed of the following ingredients:

[0131] Ginseng 9 parts, Phyllanthus emblica 9 parts, raw Coix seed 10 parts, Citron 6 parts, Citrus reticulata peel 6 parts, dandelion 15 parts, maltodextrin 10 parts, xylitol 7 parts, and silicon dioxide 5 parts.

[0132] The preparation method is the same as in Example 5.

[0133] The solid beverage prepared according to this disclosure has a good taste, can prevent clumping and moisture, and can ensure the long-term stability of the food during the packaging process.

[0134] Example 7: Food and Medicine Homologous Composition

[0135] Formula: Ginseng 8g, Phyllanthus emblica 10g, raw Coix seed 9g, Citron 9g, Citrus reticulata peel 3g, and Taraxacum mongolicum 18g;

[0136] The preparation method is the same as in Example 1.

[0137] Example 8: Food and Medicine Homologous Composition

[0138] Formula: Ginseng 10g, Phyllanthus emblica 8g, raw Coix seed 11g, Citron 4g, Citrus reticulata peel 8g, and Taraxacum mongolicum 12g;

[0139] The preparation method is the same as in Example 2.

[0140] Example 9: Food and Medicine Homologous Composition

[0141] Formula: Ginseng 5g, Phyllanthus emblica 14g, raw Coix seed 6g, Citron 10g, Citrus reticulata peel 2g, and Taraxacum mongolicum 22g;

[0142] The preparation method is the same as in Example 3.

[0143] Example 10: Food and Medicine Homologous Composition

[0144] Formula: Ginseng 12g, Phyllanthus emblica 6g, raw Coix seed 13g, Citron 2g, Citrus reticulata peel 11g, and Taraxacum mongolicum 11g;

[0145] The preparation method is the same as in Example 1.

[0146] Example 11: Food and Medicine Homologous Composition

[0147] Formula: Ginseng 9g, Phyllanthus emblica 9g, raw Coix seed 10g, Citron 6g, Citrus reticulata peel 6g, and Taraxacum mongolicum 15g;

[0148] The preparation method is the same as in Example 1.

[0149] Example 12: Solid Beverage with Medicinal and Edible Properties

[0150] Formula: 8g ginseng, 10g amla, 9g raw coix seed, 9g citron, 3g tangerine peel, 18g dandelion, 10g maltodextrin, 6g xylitol, and 3g silicon dioxide.

[0151] The preparation method is the same as in Example 4.

[0152] Example 13: Solid Beverage with Medicinal and Edible Properties

[0153] Formula: 10g ginseng, 8g amla, 11g raw coix seed, 4g citron, 8g tangerine peel, 12g dandelion, 14g maltodextrin, 8g xylitol, and 7g silicon dioxide;

[0154] The preparation method is the same as in Example 5.

[0155] Example 14: Solid Beverage with Medicinal and Edible Properties

[0156] Formula: 5g ginseng, 14g amla, 6g raw coix seed, 10g citron, 2g tangerine peel, 22g dandelion, 10g maltodextrin, 7g xylitol, and 5g silicon dioxide;

[0157] The preparation method is the same as in Example 6.

[0158] Example 15: Solid Beverage with Medicinal and Edible Properties

[0159] Formula: 12g ginseng, 6g amla, 13g raw coix seed, 2g citron, 11g tangerine peel and 11g dandelion, 10g maltodextrin, 6g xylitol and 3g silicon dioxide;

[0160] The preparation method is the same as in Example 4.

[0161] Finally, it should be noted that the above content is only used to illustrate the technical solution of this disclosure, and is not intended to limit the scope of protection of this disclosure. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of this disclosure do not depart from the substance and scope of the technical solution of this disclosure.

Claims

1. A medicinal and edible composition, characterized in that, By weight, it is made from the following raw materials: ginseng 3-13 parts, amla 5-15 parts, raw coix seed 5-15 parts, citron 1-12 parts, tangerine peel 1-12 parts and dandelion 10-25 parts.

2. The medicinal and edible composition according to claim 1, characterized in that, The medicinal and edible composition, by weight, is made from the following raw materials: 7-11 parts ginseng, 7-11 parts amla, 8-12 parts raw coix seed, 3-9 parts citron, 3-9 parts tangerine peel, and 10-20 parts dandelion; preferably, 9 parts ginseng, 9 parts amla, 10 parts raw coix seed, 6 parts citron, 6 parts tangerine peel, and 15 parts dandelion.

3. The medicinal and edible composition according to claim 1, characterized in that, It is made from the following raw materials: ginseng, amla and raw coix seed in a weight ratio of 7-11:7-11:8-12; preferably 9:9:

10.

4. The method for preparing the medicinal and edible homologous composition according to any one of claims 1-3, characterized in that, Includes the following steps: Ginseng, Phyllanthus emblica, raw Coix seed, Citrus medica, Citrus reticulata peel, and Taraxacum mongolicum were extracted with water, and then subjected to solid-liquid separation, concentration, and drying to obtain the aforementioned food-medicine homologous composition.

5. The preparation method according to claim 4, characterized in that, The amount of water added in the water extract is 5-10 times the total amount of ginseng, amla, raw coix seed, citron, tangerine peel and dandelion; And / or, the water extraction temperature is 70-90℃ and the time is 60-90min.

6. The use of the food-medicine composition according to any one of claims 1-3 or the food-medicine composition prepared by the preparation method according to any one of claims 4-5 in the preparation of products that improve Helicobacter pylori infection-related diseases.

7. The application according to claim 6, characterized in that, The Helicobacter pylori infection-related diseases include precancerous lesions of the stomach and / or damage to the gastric mucosa; preferably, the precancerous lesions of the stomach include at least one of chronic atrophic gastritis, intestinal metaplasia and low-grade intraepithelial neoplasia.

8. A product that is both food and medicine, characterized in that, The composition includes the food-medicine homology composition according to any one of claims 1-3 or the food-medicine homology composition prepared by the preparation method according to any one of claims 4-5 and acceptable excipients; preferably, the acceptable excipients are food-acceptable excipients or pharmaceutically acceptable excipients.

9. The food-medicine homology product according to claim 8, characterized in that, The acceptable excipients include at least one of fillers, sweeteners, acidulants, fruit powders, and anti-caking agents; Preferably, the filler is maltodextrin and / or starch; the sweetener is at least one of xylitol, sucralose, and erythritol; the acidulant is citric acid and / or malic acid; and the anti-caking agent is silicon dioxide and / or microcrystalline cellulose.

10. A solid beverage that is both food and medicine, characterized in that, The composition includes at least one of filler, sweetener, acidulant, fruit powder and anti-caking agent, and the food-medicine composition according to any one of claims 1-3 or the food-medicine composition prepared by the preparation method according to any one of claims 4-5; Preferably, the medicinal and edible solid beverage is made from the following raw materials in parts by weight: 3-13 parts ginseng, 5-15 parts amla, 5-15 parts raw coix seed, 1-12 parts citron, 1-12 parts tangerine peel, 10-25 parts dandelion, 10-14 parts filler, 6-8 parts sweetener, 1-5 parts fruit powder, and 3-7 parts anti-caking agent; More preferably, the medicinal and edible solid beverage is made from the following raw materials in parts by weight: 3-13 parts ginseng, 5-15 parts amla, 5-15 parts raw coix seed, 1-12 parts citron, 1-12 parts tangerine peel, 10-25 parts dandelion, 10-14 parts maltodextrin, 6-8 parts xylitol, and 3-7 parts silicon dioxide.

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