Novel use of medicinal and edible composition

Abstract

The novel use of a medicinal and edible composition based on a qi regulating, blood circulating and toxin removing method in terms of amelioration of alcoholic fatty liver disease and chemical liver injury, uric acid reduction, etc. The medicinal and edible composition is prepared from the following raw material medicines by parts by weight: 3-13 parts of ginseng, 5-15 parts of fructus phyllanthi, 5-15 parts of raw coix seed, 1-12 parts of fructus citri, 1-12 parts of exocarpium citri grandis and 10-25 parts of dandelion.

Description

A new use of a food-medicine homology composition

[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 relates to a novel use of a food-medicine homologous composition based on the principle of regulating qi, promoting blood circulation, and detoxifying, belonging to the field of traditional Chinese medicine technology. Background Technology

[0004] Ginseng is the dried root and rhizome of Panax ginseng CAMey., a plant belonging to the Araliaceae family. It has a sweet and slightly bitter taste, and is neutral in nature; it enters the spleen, lung, and heart meridians; it has the effects of greatly replenishing vital energy, restoring the pulse and consolidating the body, tonifying the spleen and lungs, promoting body fluid production, and calming the mind; it is mainly used to treat weakness and collapse, cold limbs and weak pulse, spleen deficiency with poor appetite, lung deficiency with cough and asthma, thirst due to fluid depletion, internal heat and thirst, chronic illness and emaciation, palpitations and insomnia, cold extremities; heart failure, and cardiogenic shock.

[0005] Phyllanthus emblica L., a Tibetan medicine, is the dried, ripe fruit of the plant Phyllanthus emblica L., belonging to the Euphorbiaceae family. It is sweet, sour, astringent, and cool in nature; it enters the lung and stomach meridians; it has the effects of clearing heat and cooling blood, promoting digestion and strengthening the stomach, and generating fluids and relieving cough; it is mainly used to treat blood heat and blood stasis, indigestion, abdominal distension, cough, sore throat, and dry mouth.

[0006] Job's tears (Coix lacryma-jobi) is the dried, mature seed of the grass *Coix lacryma-jobi* L. var. *ma-yuen* (ROman.) Stapf. It has a sweet and bland taste, and is cool in nature; it enters the spleen, stomach, and lung meridians. It functions to strengthen the spleen and eliminate dampness, relieve numbness and stop diarrhea, clear heat and drain pus. It is used to treat edema, beriberi, dysuria, damp-heat arthralgia with contractures, spleen deficiency diarrhea, lung pain, intestinal abscess, and flat warts.

[0007] Citron is the dried, ripe fruit of *Citrus medica* L. or *Citrus wilsonii* Tanaka, both belonging to the Rutaceae family. It is pungent, bitter, sour, and warm in nature; it enters the liver, spleen, and lung meridians; it has the effects of soothing the liver and regulating qi, relieving chest congestion, and resolving phlegm; it is mainly used to treat liver and stomach qi stagnation, chest and rib pain, abdominal distension, vomiting, belching, and cough with excessive phlegm.

[0008] Huazhou tangerine peel is the dried outer peel of the immature or nearly mature fruit of the Rutaceae plant, Pomelo or Pomelo huazhouensis. It has a pungent, bitter, and warm flavor; it enters the lung and spleen meridians; and it has the effects of regulating qi, relieving chest congestion, drying dampness and resolving phlegm, and promoting digestion.

[0009] Dandelion is the dried whole herb of *Taraxacum mongolicum* Hand-Mazz., *Taraxacum sinicum* Kitag., or several other species in the same genus, belonging to the Asteraceae family. It is bitter, sweet, and cold in nature; it enters the liver and stomach meridians; it has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting urination; it is mainly used to treat boils and carbuncles, mastitis, scrofula, red eyes, sore throat, lung abscess, intestinal pain, damp-heat jaundice, and painful urination due to heat.

[0010] All of the above-mentioned drugs are of the same origin as food and medicine. When used in combination, they have the effects of regulating qi (tonifying qi), promoting blood circulation and removing blood stasis, clearing heat and detoxifying. They can be used as an adjunct treatment for chronic atrophic gastritis, intestinal metaplasia and low-grade intraepithelial neoplasia, prevent precancerous lesions of the stomach, and help improve gastric mucosal damage. Currently, no other uses of this composition have been reported. Summary of the Invention

[0011] To address the problems existing in the prior art, this disclosure provides a new use for a medicinal and edible homology composition in the following aspects:

[0012] As a first aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a medicament for treating alcoholic fatty liver.

[0013] As a second aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a medicament for treating chemically induced liver injury.

[0014] As a third aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a drug with uric acid-lowering effects.

[0015] As a fourth aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of medicaments for antiviral pneumonia and / or antibacterial pneumonia.

[0016] As a fifth aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a medicament for enhancing immunity.

[0017] As a sixth aspect of this disclosure, this disclosure provides the use of a food-medicine composition in the preparation of a medicament for improving sleep.

[0018] As a seventh aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a lipid-lowering drug.

[0019] As the eighth aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a hypoglycemic drug.

[0020] As a ninth aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a medicament with renal protective effects.

[0021] As the tenth aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a medicament for regulating intestinal flora.

[0022] As the eleventh aspect of this disclosure, this disclosure provides the use of a food-medicine homology composition in the preparation of a medicament for improving Helicobacter pylori infection-related diseases.

[0023] In some embodiments, the application is the use of the above-mentioned food-medicine homology composition in the preparation of a medicament for improving precancerous lesions of the stomach.

[0024] Preferably, the precancerous lesions of the stomach include at least one of chronic atrophic gastritis, intestinal metaplasia, and low-grade intraepithelial neoplasia.

[0025] In some embodiments, the application is the use of the above-mentioned food-medicine homology composition in the preparation of a medicament for improving gastric mucosal damage.

[0026] The medicinal and edible composition disclosed herein is made from the following raw materials in parts by weight: 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.

[0027] 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.

[0028] 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.

[0029] In some embodiments, the weight ratio of ginseng, amla, and raw coix seed is 7-11:7-11:8-12; preferably 9:9:10.

[0030] The method for preparing the food-medicine homology composition disclosed herein includes the following steps:

[0031] 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.

[0032] 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.

[0033] More preferably, the water extraction temperature is 70-90℃ and the time is 60-90 minutes.

[0034] Preferably, the solid-liquid separation includes centrifugation and filtration.

[0035] Preferably, the concentration is vacuum concentration, with a concentration temperature of 70-80℃ and a vacuum degree of 0.07-0.01 MPa.

[0036] More preferably, the concentration is to 15-35% of the original concentrated liquid volume, even more preferably 18-30%; and more preferably 20-30%.

[0037] Preferably, the drying is freeze drying and / or spray drying, more preferably spray drying.

[0038] Specifically, the inlet air temperature of the spray dryer is 150-160℃, and the outlet air temperature is 95-105℃.

[0039] Compared with the prior art, this disclosure has the following beneficial effects:

[0040] Animal experiments have shown that the composition disclosed herein has a wide range of applications: it exhibits significant effects in improving alcoholic fatty liver, chemical liver damage, lowering uric acid, antiviral pneumonia, antibacterial pneumonia, enhancing immunity, improving sleep, lowering blood sugar, lowering blood lipids, regulating intestinal flora, fighting Helicobacter pylori, improving gastric mucosal damage, and protecting the kidneys. Attached Figure Description

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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

[0045] 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.

[0046] 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.

[0047] 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.

[0048] Example 1: A Composition of Food and Medicine

[0049] The components of the food-medicine homology composition in Example 1 are shown in Table 1.

[0050] Table 1. Composition of Food-Medicine Homologous Compositions

[0051] Based on the formulation in Table 1, prepare the food-medicine homology composition according to the following steps.

[0052] 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%.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] Example 2: Food and Medicine Homologous Composition

[0057] The components of the food-medicine homology composition in Example 2 are shown in Table 2.

[0058] Table 2. Composition of Food-Medicine Homologous Compositions

[0059] Based on the formulation in Table 2, prepare the food-medicine homology composition according to the following steps.

[0060] 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%.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] Example 3: Food and Medicine Homologous Composition

[0065] The components of the food-medicine homology composition in Example 3 are shown in Table 3.

[0066] Table 3. Composition of Food-Medicine Homologous Compositions

[0067] Based on the formulation in Table 3, prepare the food-medicine homology composition according to the following steps.

[0068] 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%.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] Comparative Example 1: Food and Medicine Homologous Composition

[0073] 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.

[0074] Table 4. Composition of Food-Medicine Homologous Compositions

[0075] The preparation method is the same as in Example 1.

[0076] Comparative Example 2: Food and Medicine Homologous Composition

[0077] 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.

[0078] Table 5. Composition of Food-Medicine Homologous Compositions

[0079] The preparation method is basically the same as in Example 1.

[0080] Comparative Example 3: Food and Medicine Homologous Composition

[0081] 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.

[0082] Table 6. Composition of Food-Medicine Homologous Compositions

[0083] The preparation method is the same as in Example 1.

[0084] I. Animal Experiment Verification

[0085] 1. Materials

[0086] 1.1 Main drugs

[0087] 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;

[0088] Test substances: The homologous medicated diet composition prepared by the method of regulating qi, activating blood circulation and detoxifying in Example 1, and the homologous medicated diet compositions prepared in Comparative Examples 1-3 were uniformly dispensed by the Granule Pharmacy of Dongzhimen Hospital, Beijing University of Chinese Medicine.

[0089] 1.2 Main instruments

[0090] JB-P5 embedding machine: Wuhan Junjie Electronics Co., Ltd.; RM2016 pathological slicer: Shanghai Leica Instruments Co., Ltd.; KD-P tissue spreading machine: Jinhua Cody Instrument Equipment Co., Ltd., Zhejiang; DHG-9140A oven: Shanghai Huita Instrument Manufacturing Co., Ltd.; NIKON ECLIPSE CI upright fluorescence microscope: Nikon, Japan; Pannoramic MIDI scanner: 3DHISTECH Co.

[0091] 1.3 Animals

[0092] 60 male Wistar rats of SPF grade at 3 weeks of age were purchased from Beijing Speifo (Beijing) Biotechnology Co., Ltd., and the experimental animal production license number was SCXK (Beijing) 2019-0010. They were housed in the SPF scientific research experimental center of Beijing University of Chinese Medicine, with the temperature at (23±3)°C and the relative humidity at 40% - 60%. The light and dark cycle was 12h. During the feeding period, they were allowed to eat and drink freely. After 1 week of adaptive feeding, the experiment was carried out.

[0093] 1.4 Ethical review

[0094] This experiment was approved by the Experimental Animal Ethics Sub-committee of the Academic Committee of Beijing University of Chinese Medicine, and the ethical number was: BUCM-2023022303-1151.

[0095] 2. Methods

[0096] 2.1 Replication of animal model

[0097] The PLGC rat model was established using the MNNG multifactorial method for 24 weeks, with the rats allowed free access to 120 μg / mL of water daily. MNNG + 0.9% saline solution (MNNG stock solution concentration 1g / L, stored at 4℃ protected from light, prepared fresh each time to ensure sodium chloride dissolution, no other drinking water during the period, changed every 24-48 hours), and fed freely daily with SPF grade pelleted feed containing 0.05% ranitidine (no other food during the period); at the same time, irregular hunger and satiety were implemented, that is, fasting on Tuesdays and Fridays (and after fasting on the same day, 2% sodium salicylate solution was administered by gavage at a dose of 5mL / kg), and satiated on Mondays, Wednesdays, Thursdays, Saturdays and Sundays; the criteria for successful model replication were the observation of atrophy, intestinal metaplasia or low-grade intraepithelial neoplasia of the gastric mucosa in rats by histopathological examination, among which atrophy, intestinal metaplasia and low-grade intraepithelial neoplasia were quantitatively scored according to the "Consensus Opinion on the Diagnosis and Treatment of Chronic Atrophic Gastritis by Integrated Traditional Chinese and Western Medicine (2017)" and the "Expert Consensus on the Treatment Strategy of Precancerous State and Precancerous Lesions of Gastric Mucosa in China (2020)".

[0098] 2.2 Animal grouping and administration

[0099] 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.

[0100] 2.3 HE staining method

[0101] 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.

[0102] 2.4 Statistical Methods

[0103] All data were statistically analyzed 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. p < 0.05 was considered statistically significant.

[0104] 3. Results

[0105] 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.

[0106] II. Clinical efficacy observation

[0107] 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.

[0108] 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.

[0109] Experimental completion status and baseline characteristics:

[0110] 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.

[0111] Table 7. Traditional Chinese Medicine Syndrome Scoring Table

[0112] Example 4: Food and Medicine Homologous Composition

[0113] Formula: Ginseng 8g, Phyllanthus emblica 10g, raw Coix seed 9g, Citron 9g, Citrus reticulata peel 3g, and Taraxacum mongolicum 18g;

[0114] The preparation method is the same as in Example 1.

[0115] Example 5: Food and Medicine Homologous Composition

[0116] Formula: Ginseng 10g, Phyllanthus emblica 8g, raw Coix seed 11g, Citron 4g, Citrus reticulata peel 8g, and Taraxacum mongolicum 12g;

[0117] The preparation method is the same as in Example 2.

[0118] Example 6: Food and Medicine Homologous Composition

[0119] Formulation: 5g of ginseng, 14g of phyllanthus emblica, 6g of coix seed, 10g of citron, 2g of tangerine peel, and 22g of dandelion;

[0120] The preparation method is the same as that in Example 3.

[0121] Example 7 Food-Drug Homologous Composition

[0122] Formulation: 12g of ginseng, 6g of phyllanthus emblica, 13g of coix seed, 2g of citron, 11g of tangerine peel, and 11g of dandelion;

[0123] The preparation method is the same as that in Example 1.

[0124] Example 8 Food-Drug Homologous Composition

[0125] Formulation: 9g of ginseng, 9g of phyllanthus emblica, 10g of coix seed, 6g of citron, 6g of tangerine peel, and 15g of dandelion;

[0126] The preparation method is the same as that in Example 1.

[0127] Effect Example 1 Effect of Improving Alcoholic Fatty Liver

[0128] 1. Experimental Materials

[0129] 1.1. Sample Preparation Information

[0130] The composition of the present disclosure (prepared according to Example 1), with the solvent being standard dilution water.

[0131] Positive control: RU21, white tablets, batch number 25802, Spirit Sciences USA, with the solvent being ultrapure water.

[0132] 1.2. Experimental Animals

[0133] The zebrafish are all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt is added to every 1 L of reverse osmosis water, the conductivity is 450 - 550 μS / cm; the pH is 6.5 - 8.5; the hardness is 50 - 100 mg / LCaCO3), provided by the fish-raising center of our company. The license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0134] 1.3. Instruments, Consumables and Reagents

[0135] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, America); Digital display horizontal decolorizing shaker (2D-9556-A, Taicang Hualida Experimental Equipment Co., Ltd., China); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China).

[0136] Anhydrous ethanol (batch number 20240414, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Methylcellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Oil Red O (batch number SHBN4926, Sigma, USA); 4% tissue cell fixative (batch number 20230401, Beijing Solarbio Science & Technology Co., Ltd., China); 1,2-propanediol (batch number 20211117, Sinopharm Chemical Reagent Co., Ltd., China); PBS phosphate buffer (dry powder) (batch number 24002553, Biosharp, China).

[0137] 2. Experimental Methods

[0138] Zebrafish of the Albino strain (5dpf melanin allele mutant) were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Samples (concentrations shown in Table 8) and a positive control (RU21 at 100 μg / mL) were administered in water. A normal control and a model control were also included, with a volume of 3 mL per well. Except for the normal control, all other experimental groups were treated with anhydrous ethanol to establish a zebrafish alcoholic fatty liver model. After treatment at 28℃ for one day, Oil Red O staining was performed. Ten zebrafish from each experimental group were randomly selected and photographed under a dissecting microscope. Data were analyzed and collected using NIS-Elements D 3.20 advanced image processing software. The intensity of liver fat staining was analyzed, and the statistical analysis results of this index were used to evaluate the efficacy of the samples in improving alcoholic fatty liver. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software, with p < 0.05 indicating statistical significance.

[0139] 3. Experimental Results

[0140] Under the experimental conditions described herein, the composition exhibits efficacy in improving alcoholic fatty liver disease, specifically by reducing the intensity of liver fat staining. See Table 8 for details.

[0141] Table 8. Experimental results evaluating the efficacy of the samples in improving alcoholic fatty liver (n=10)

[0142] Compared with the model control group, **p < 0.01,***p < 0.001.

[0143] Effect Example 2 Assisting Protection Effect on Chemical Liver Injury

[0144] 1. Experimental Materials

[0145] 1.1. Sample Preparation Information

[0146] The composition of the present disclosure (prepared according to Example 1), and the solvent is standard dilution water.

[0147] Positive control: N-acetyl-L-cysteine (hereinafter referred to as NAC), white powder, batch number I2016139, Shanghai Aladdin Biochemical Technology Co., Ltd., and the solvent is standard dilution water.

[0148] 1.2. Experimental Animals

[0149] Zebrafish are all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt is added to every 1 L of reverse osmosis water, the conductivity is 450 - 550 μS / cm; pH is 6.5 - 8.5; hardness is 50 - 100 mg / LCaCO3), provided by the fish-raising center of our company, and the license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0150] 1.3. Instruments, Consumables and Reagents

[0151] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Beilamber Biotechnology Co., Ltd., China).

[0152] Dimethyl sulfoxide (DMSO, batch number BCCD8942, Sigma, Switzerland); Paracetamol (batch number E2113205, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Methyl cellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China).

[0153] 2. Experimental Methods

[0154] Wild-type AB strain zebrafish (3dpf) were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Water-soluble samples (concentrations shown in Table 9) were administered, with a positive control of NAC at a concentration of 1.60 μg / mL. A normal control group and a model control group were also included, with a volume of 3 mL per well. Except for the normal control group, all experimental groups were treated with water-soluble acetaminophen to establish a chemical liver injury model. After treatment at 28℃ for 2 days, 10 zebrafish from each experimental group were randomly selected and photographed under a dissecting microscope. Data were analyzed and collected using NIS-Elements D 3.20 advanced image processing software. The liver area, average liver brightness, and yolk sac area were analyzed. Statistical analysis of these indicators was used to evaluate the auxiliary protective efficacy against chemical liver injury. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0155] 3. Experimental Results

[0156] Under the experimental conditions described herein, the composition exhibits adjuvant protective efficacy against chemically induced liver injury, specifically by improving liver degeneration, liver atrophy, and delayed yolk sac absorption. See Table 9 for details.

[0157] Table 9. Experimental results evaluating the auxiliary protective efficacy against chemical liver injury in samples (n=10)

[0158] Compared with the model control group, *p<0.05, **p<0.01, ***p<0.001.

[0159] Example 3: Evaluation of the uric acid-lowering efficacy

[0160] 1. Experimental Materials

[0161] 1.1. Sample Preparation Information

[0162] The composition disclosed herein (prepared according to Example 1) uses standard dilution water as the solvent.

[0163] Positive control: Allopurinol, white powder, batch number: MKCM0752, Sigma, solvent: DMSO.

[0164] 1.2. Laboratory Animals

[0165] Zebrafish were all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, the conductivity was 450 - 550 μS / cm; pH was 6.5 - 8.5; hardness was 50 - 100 mg / LCaCO3). They were provided by the fish-raising center of our company. The license number for the use of experimental animals was: SYXK(Zhe)2022 - 0004. The feeding management met the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number was: IACUC - 2025 - 202509030009 - 01.

[0166] 1.3. Instruments, Consumables and Reagents

[0167] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); Multifunctional microplate reader (SPARK, TECAN, Austria); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China); Black-bottom 96-well microplate (Costar, China).

[0168] Potassium oxonate (batch number B2226348, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Sodium xanthine (batch number P2307210074, Sigma, USA); Dimethyl sulfoxide (DMSO, batch number BCCD8942, Sigma, Switzerland); AmplexTM Red Uric Acid / Uricase Assay Kit (batch number 2077764, Thermo Fisher Scientific, USA).

[0169] 2. Experimental Methods

[0170] Wild-type AB strain zebrafish at 4 days post-fertilization (4 dpf) were randomly selected and placed in 6-well plates, with 30 zebrafish in each well (experimental group). The samples were administered in water solution (concentrations are shown in Table 10), and the positive control was allopurinol at 136 μg / mL. At the same time, a normal control group and a model control group were set up, and the volume of each well was 3 mL. Except for the normal control group, the other experimental groups were all administered potassium oxonate and sodium xanthine in water solution to establish a hyperuricemia model in zebrafish. After treatment at 28°C for 2 days, the Amplex TM Red Uric Acid kit was used, and the multifunctional microplate reader software was used to collect data and analyze the fluorescence value of uric acid in zebrafish. The anti-hyperuricemic efficacy of the samples was evaluated based on the statistical analysis results of this index. The statistical processing results were expressed as mean ± SE. SPSS software was used for statistical analysis, and p < 0.05 indicated that the difference was statistically significant.

[0171] 3. Experimental Results

[0172] Under the conditions of this experiment, the disclosed composition has the effect of reducing uric acid, specifically manifested as reducing the fluorescence value of uric acid. See Table 10 for details.

[0173] Table 10 Experimental Results of the Evaluation of the Effect of the Sample on Reducing Uric Acid (n = 3)

[0174] Compared with the model control group, **p < 0.01, ***p < 0.001.

[0175] Effect Example 4 Anti-viral Pneumonia Effect

[0176] 1. Experimental Materials

[0177] 1.1 Sample Preparation Information

[0178] The disclosed composition (prepared according to Example 1), and the solvent is standard dilution water.

[0179] Positive control: Dexamethasone acetate, batch number B1828095, Shanghai Aladdin Biochemical Technology Co., Ltd., and the solvent is DMSO.

[0180] 1.2 Experimental Animals

[0181] Zebrafish are all raised in fish culture water at 28°C (water quality: 200 mg of instant sea salt is added to every 1 L of reverse osmosis water, the conductivity is 450 - 550 μS / cm; pH is 6.5 - 8.5; hardness is 50 - 100 mg / LCaCO3), provided by the fish culture center of this company, and the license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0182] 1.3 Instruments, Consumables and Reagents

[0183] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, America); Electric focusing continuous zoom fluorescence microscope (AZ100, Nikon, Japan); Microinjection instrument (IM300, Narishige, Japan); Pulling needle instrument (PC - 10, Narishige, Japan); 6 - well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China).

[0184] Polyinosinic-polycytidylic acid (poly(I:C)) (hereinafter referred to as poly(I:C), batch number 1-KMS-178-2, TRC, Canada); methylcellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); 0.9% sodium chloride injection (batch number S21091609, Hunan Kelun Pharmaceutical Co., Ltd., China); dimethyl sulfoxide (DMSO, batch number 20250214, Sinopharm Chemical Reagent Co., Ltd., China).

[0185] 2. Experimental Methods

[0186] Five-day-old (5 dpf) transgenic zebrafish with green fluorescent neutrophil MPX strain were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Samples were administered in water (concentrations shown in Table 11), and a normal control group and a model control group were also included, with a volume of 3 mL per well. Except for the normal control group, all other experimental groups received poly(I:C) injection into the swim bladder to establish a zebrafish viral pneumonia model. After treatment at 28℃ for 3 h, 10 zebrafish from each experimental group were randomly selected and photographed under a fluorescence microscope. Data were analyzed and collected using NIS-Elements D 3.20 advanced image processing software to analyze the number of neutrophils in the swim bladder. The statistical analysis results were used to evaluate the antiviral pneumonia efficacy of the samples. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software, and p < 0.05 indicated statistical significance.

[0187] 3 Experimental Results

[0188] Under the experimental conditions described herein, the disclosed composition exhibits antiviral pneumonia efficacy. See Table 11 for details.

[0189] Table 11. Experimental results of the antiviral pneumonia efficacy of the samples (n=10)

[0190] Compared with the model control group, **p<0.01, ***p<0.001.

[0191] Example 5: Antibacterial pneumonia efficacy

[0192] 1. Experimental Materials

[0193] 1.1 Sample Preparation Information

[0194] The composition disclosed herein (prepared according to Example 1) uses standard dilution water as the solvent.

[0195] Positive control: Dexamethasone acetate, batch number B1828095, Shanghai Aladdin Biochemical Technology Co., Ltd., solvent: DMSO.

[0196] 1.2 Experimental animals

[0197] Zebrafish were all raised in fish culture water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, with a conductivity of 450 - 550 μS / cm; pH of 6.5 - 8.5; hardness of 50 - 100 mg / LCaCO3). They were provided by the fish culture center of our company, and the experimental animal use license number is: SYXK(Zhe)2022 - 0004. The feeding management complied with the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0198] 1.3 Instruments, consumables and reagents

[0199] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, America); Electric focusing continuously variable fluorescence microscope (AZ100, Nikon, Japan); Microinjector (IM300, Narishige, Japan); Pulling needle instrument (PC - 10, Narishige, Japan); 6 - well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China).

[0200] LPS lipopolysaccharide (batch number 1001164401, SIGMA, USA); Methyl cellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Sodium chloride injection (batch number S21091609, Hunan Kelun Pharmaceutical Co., Ltd., China); Dimethyl sulfoxide (DMSO, batch number 20250214, Sinopharm Chemical Reagent Co., Ltd., China).

[0201] 2 Experimental methods

[0202] Transgenic zebrafish of the MPX strain, 5 days post-fertilization (5 dpf), with green fluorescent neutrophil counts, were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Samples were administered via water-soluble injection (concentrations shown in Table 12), and a normal control group and a model control group were also included, with a volume of 3 mL per well. Except for the normal control group, all other experimental groups received LPS injection into the swim bladder to establish a zebrafish bacterial pneumonia model. After treatment at 28℃ for 3 h, 10 zebrafish from each experimental group were randomly selected and photographed under a fluorescence microscope. Data were analyzed and collected using NIS-Elements D 3.20 advanced image processing software. The number of neutrophils in the swim bladder was analyzed, and the statistical analysis results were used to evaluate the antibacterial pneumonia efficacy of the samples. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software, and p < 0.05 indicated statistical significance.

[0203] 3 Experimental Results

[0204] Under the experimental conditions described herein, the disclosed composition exhibits antibacterial pneumonia efficacy. See Table 12 for details.

[0205] Table 12 Results of the experimental results on the antibacterial pneumonia efficacy of the samples (n=10)

[0206] Compared with the model control group, *p<0.05, **p<0.01, ***p<0.001.

[0207] Example 6: Enhanced Immunity

[0208] 1. Experimental Materials

[0209] 1.1 Sample Preparation Information

[0210] The composition disclosed herein (prepared according to Example 1) uses standard dilution water as the solvent.

[0211] Positive control: Bailin Capsules (hereinafter referred to as Bailin Capsules), batch number 2411018D, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., solvent is standard dilution water.

[0212] 1.2 Laboratory Animals

[0213] Zebrafish were all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, with a conductivity of 450-550 μS / cm; pH of 6.5-8.5; hardness of 50-100 mg / LCaCO3). They were provided by the fish-raising center of our company. The experimental animal use license number was: SYXK(Zhe)2022-0004. The feeding management met the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number was: IACUC-2025-202509030009-01.

[0214] 1.3 Instruments, Consumables and Reagents

[0215] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Electrically focused continuous zoom fluorescence microscope (AZ100, Nikon, Japan); Precision electronic balance (CP214, OHAUS, USA); Microinjector (IM-300, Narishige, Japan); Pulling needle instrument (PC-10, Narishige, Japan); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China).

[0216] Vinorelbine tartrate injection (batch number 600211003, Jiangsu Hansoh Pharmaceutical Co., Ltd., China); 0.9% sodium chloride injection (batch number S21091609, Hunan Kelun Pharmaceutical Co., Ltd., China); Methyl cellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China).

[0217] 2 Experimental Methods

[0218] Randomly select transgenic macrophage green fluorescent zebrafish at 3 days post-fertilization (3dpf) into 6-well plates, with 30 zebrafish treated in each well (experimental group). Administer the sample by water solution (concentration shown in Table 13), with the positive control of Bailing Capsule at a concentration of 15.0 μg / mL. At the same time, set up a normal control group and a model control group, with a volume of 3 mL per well. Except for the normal control group, the other experimental groups were intravenously injected with vinorelbine tartrate injection to establish a zebrafish immune deficiency model. After treatment at 28°C for 48 hours, randomly select 10 zebrafish from each experimental group and place them under a fluorescence microscope for photography. Use NIS-Elements D 3.20 advanced image processing software to collect data and analyze the fluorescence intensity of zebrafish macrophages. Evaluate the efficacy of the sample in enhancing immunity based on the statistical analysis results of this index. The statistical processing results are expressed as mean ± SE. Use SPSS software for statistical analysis, and p<0.05 indicates that the difference is statistically significant.

[0219] 3 Experimental Results

[0220] Under the conditions of this experiment, the composition of the present disclosure has the effect of enhancing immunity. See Table 13 for details.

[0221] Table 13 Experimental Results of the Immunity Enhancement Effect of Samples (n = 10)

[0222] Compared with the model control group, **p < 0.01, ***p < 0.001.

[0223] Effect Example 7 Sleep Improvement Effect

[0224] 1. Experimental Materials

[0225] 1.1 Sample Preparation Information

[0226] The composition of the present disclosure (prepared according to Example 1), with the solvent being standard dilution water.

[0227] Positive control: Melatonin, white powder, batch number F1804064, Shanghai Aladdin Biochemical Technology Co., Ltd., with the solvent being DMSO.

[0228] 1.2 Experimental Animals

[0229] Zebrafish were all raised in fish culture water at 28 °C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, with a conductivity of 450 - 550 μS / cm; pH of 6.5 - 8.5; hardness of 50 - 100 mg / LCaCO3), provided by the fish culture center of this company. The license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0230] 1.3 Instruments, Consumables and Reagents

[0231] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 6 - well plate (batch number BB1000324, Zhejiang Beranbo Biotechnology Co., Ltd., China); 96 - well plate (Nest Biotech, China); Zebrafish behavior analysis system (Zebra Lab 3.22.3.31, Viewpoint, France).

[0232] Pentylenetetrazole (PTZ, batch number A27O8L46880, Shanghai Yuanye Biotechnology Co., Ltd., China); Dimethyl sulfoxide (DMSO, batch number 20250214, Sinopharm Chemical Reagent Co., Ltd., China).

[0233] 2 Experimental Methods

[0234] Wild-type AB strain zebrafish, 5 days post-fertilization (5 dpf), were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Water-soluble samples (concentrations shown in Table 14) were administered, along with a positive control of melatonin at a concentration of 125 μg / mL. A normal control group and a model control group were also included, with a volume of 3 mL per well. After treatment at 28℃ for 1 day, except for the normal control group, all other experimental groups were given water-soluble PTZ to establish a zebrafish insomnia model. The zebrafish were immediately placed in a behavioral analyzer, and their arousal activity and total arousal time were measured within 1 hour. Statistical analysis of these indicators was used to evaluate the sleep-improving efficacy of the samples. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0235] 3 Experimental Results

[0236] Under the experimental conditions described herein, the disclosed composition has the effect of improving sleep. See Table 14 for details.

[0237] Table 14. Experimental results of the sleep-improving effects of the samples (n=10)

[0238] Compared with the model control group, **p<0.01, ***p<0.001.

[0239] Example 8: Lipid-lowering effect (I)

[0240] 1. Experimental Materials

[0241] 1.1 Sample Preparation Information

[0242] The composition disclosed herein (prepared according to Example 1) uses standard dilution water as the solvent.

[0243] Positive control: Atorvastatin calcium, white tablets, batch number 8177245, Pfizer Pharmaceuticals Ltd., solvent: DMSO.

[0244] 1.2 Laboratory Animals

[0245] Zebrafish were all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, with a conductivity of 450 - 550 μS / cm; pH of 6.5 - 8.5; hardness of 50 - 100 mg / LCaCO3). They were provided by the fish-raising center of our company. The license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0246] 1.3 Instruments, Consumables and Reagents

[0247] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, America); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China); Shaking脱色 shaker (2D - 9556 - A, Taicang Huilida Experimental Equipment Co., Ltd., China); Ultrasonic cleaner (JP - 010T, Shenzhen Jiemeng Cleaning Equipment Co., Ltd., China).

[0248] Methyl cellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Dimethyl sulfoxide (DMSO, batch number I2229063, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Oil Red O (batch number SHBN4926, Sigma, USA); 1,2 - propanediol (batch number 20230614, Sinopharm Chemical Reagent Co., Ltd., China); 4% tissue cell fixative (batch number 20230401, Beijing Solarbio Science & Technology Co., Ltd., China); PBS phosphate buffer (dry powder) (batch number 23045283, Biosharp, China); Formamide (batch number L1905088, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Sodium chloride (batch number 20220216, Sinopharm Chemical Reagent Co., Ltd., China); Hydrogen peroxide solution (batch number G2023089, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Egg yolk powder (batch number 20230203, Zhejiang Aige Biotechnology Co., Ltd., China).

[0249] 2 Experimental Methods

[0250] It should be noted that the "脱色" in "Shaking脱色 shaker" seems to be an incorrect or incomplete expression in Chinese. It might need to be corrected according to the actual situation. Here it is translated as it is for the purpose of following the translation rules.Wild-type AB strain zebrafish, 5 days post-fertilization (5 dpf), were randomly selected and placed in beakers, with 30 zebrafish treated in each beaker (experimental group). Water-soluble samples (concentrations shown in Table 15) were administered, with atorvastatin calcium at a concentration of 11.6 μg / mL as a positive control. A normal control group and a model control group were also established, with each beaker containing 25 mL. Except for the normal control group, all other concentration groups were fed a high-sugar, high-fat diet to establish a zebrafish hyperlipidemia model. After treatment at 28℃ for 2 days, 10 zebrafish from each experimental group were randomly selected and photographed under a dissecting microscope. Data were collected using NIS-Elements D 3.20 advanced image processing software, and the intensity of fat staining in the tail vessels was analyzed. The lipid-lowering efficacy of the samples was evaluated based on the statistical analysis results of this index. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0251] 3 Experimental Results

[0252] Under the experimental conditions described herein, the composition exhibits lipid-lowering effects, specifically by reducing triglyceride levels in the tail vessels. See Table 15 for details.

[0253] Table 15. Experimental results of lipid-lowering efficacy of samples (n=10)

[0254] Compared with the model control group, **p<0.01, ***p<0.001.

[0255] Example 9: Lipid-lowering effect (II)

[0256] 1. Testing materials

[0257] 1.1 Sample Preparation Information

[0258] The composition disclosed herein (prepared according to Example 1) uses standard dilution water as the solvent.

[0259] Positive control: Atorvastatin calcium, white tablets, batch number 8177245, Pfizer Pharmaceuticals Ltd., solvent: DMSO.

[0260] 1.2 Laboratory Animals

[0261] Zebrafish were all raised in fish culture water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, with a conductivity of 450 - 550 μS / cm; pH of 6.5 - 8.5; hardness of 50 - 100 mg / LCaCO3). They were provided by the fish breeding center of our company. The experimental animal use license number is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0262] 1.3 Instruments, Consumables and Reagents

[0263] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Visual Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, America); 6 - well plate (Zhejiang Beranbo Biotechnology Co., Ltd., China); Shaking decolorizing shaker (2D - 9556 - A, Taicang Hualida Experimental Equipment Co., Ltd., China); Ultrasonic cleaner (JP - 010T, Shenzhen Jiemeng Cleaning Equipment Co., Ltd., China).

[0264] Methyl cellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Dimethyl sulfoxide (DMSO, batch number I2229063, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Oil Red O (batch number SHBN4926, Sigma, USA); 1,2 - propanediol (batch number 20230614, Sinopharm Chemical Reagent Co., Ltd., China); 4% tissue cell fixative (batch number 20230401, Beijing Solarbio Science & Technology Co., Ltd., China); PBS phosphate buffer (dry powder) (batch number 23045283, Biosharp, China); Formamide (batch number L1905088, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Sodium chloride (batch number 20220216, Sinopharm Chemical Reagent Co., Ltd., China); Hydrogen peroxide solution (batch number G2023089, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Egg yolk powder (batch number 20230203, Zhejiang Aige Biotechnology Co., Ltd., China).

[0265] 2 Experimental Methods

[0266] Wild-type AB strain zebrafish, 5 days post-fertilization (5 dpf), were randomly selected and placed in beakers, with 30 zebrafish treated in each beaker (experimental group). Water-soluble samples (concentrations shown in Table 16) were administered, with atorvastatin calcium at a concentration of 11.6 μg / mL as a positive control. A normal control group and a model control group were also established, with each beaker containing 25 mL. Except for the normal control group, all other concentration groups were fed a high-sugar, high-fat diet to establish a zebrafish hyperlipidemia model. After treatment at 28℃ for 2 days, 10 zebrafish from each experimental group were randomly selected and photographed under a dissecting microscope. Data were collected using NIS-Elements D 3.20 advanced image processing software, and the intensity of fat staining in the tail vessels was analyzed. The lipid-lowering efficacy of the samples was evaluated based on the statistical analysis results of this index. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0267] 3 Experimental Results

[0268] Under the experimental conditions described herein, the composition exhibits lipid-lowering effects, specifically by reducing cholesterol fluorescence intensity. See Table 16 for details.

[0269] Table 16. Experimental results of lipid-lowering efficacy of samples (n=10)

[0270] Compared with the model control group, *p<0.05, ***p<0.001.

[0271] Example 10: Blood sugar lowering effect

[0272] 1. Experimental Materials

[0273] 1.1 Sample Preparation Information

[0274] The composition disclosed herein (prepared according to Example 1) uses standard dilution water as the solvent.

[0275] Positive control: Metformin hydrochloride tablets (hereinafter referred to as metformin), white tablets, batch number ACR8818, Sino-American Shanghai Squibb Co., Ltd., solvent is ultrapure water.

[0276] 1.2 Laboratory Animals

[0277] Zebrafish were all raised in fish-raising water at 28°C (Water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, with a conductivity of 450 - 550 μS / cm; pH of 6.5 - 8.5; hardness of 50 - 100 mg / LCaCO3). They were provided by the fish-raising center of our company. The experimental animal use license number is: SYXK(Zhe)2022 - 0004. The feeding management complies with the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0278] 1.3 Instruments, Consumables and Reagents

[0279] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China); Blood glucose meter (ACCU-CHEK Performa, Roche Diagnostic Products (Shanghai) Co., Ltd., China); Blood glucose meter test strips (batch number 478829, Roche Diagnostic Products (Shanghai) Co., Ltd., China); Ultrasonic cleaner (JP-010T, Shenzhen Jiemeng Cleaning Equipment Co., Ltd., China); Automatic sample rapid grinder (JXFSTPRP-24L, Shanghai Jingxin Experimental Equipment Science and Technology Department, China); High-speed refrigerated centrifuge (Heraeus Fresco17, ThermoFisher, Germany).

[0280] Absolute ethanol (batch number 20240123, Sinopharm Chemical Reagent Co., Ltd., China); Methyl cellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); D-(+)-glucose (batch number D2518345, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Egg yolk powder (batch number 20230203, Zhejiang Aige Biotechnology Co., Ltd., China).

[0281] 2 Experimental Methods

[0282] Wild-type AB strain zebrafish at 5 days post-fertilization (5 dpf) were randomly selected and placed in beakers, with 30 zebrafish in each beaker (experimental group). The samples were administered in aqueous solution (concentrations are shown in Table 17), and the positive control metformin was at a concentration of 400 μg / mL. At the same time, a normal control group and a model control group were set up, and the volume of each beaker was 25 mL. Except for the normal control group, high-sugar and high-fat diets were administered in aqueous solution to zebrafish in the other concentration groups to establish a hyperglycemic model in zebrafish. After 2 days of treatment at 28 °C, the zebrafish were washed 3 times with standard dilution water, and data were collected using a blood glucose meter. The glucose levels of zebrafish were analyzed and statistically analyzed, and the hypoglycemic efficacy of the samples was evaluated based on the statistical analysis results of this index. The statistical processing results were expressed as mean ± SE. Statistical analysis was performed using SPSS software, and p < 0.05 indicated that the difference was statistically significant.

[0283] 3 Experimental results

[0284] Under the conditions of this experiment, the disclosed composition has hypoglycemic efficacy. See Table 17 for details.

[0285] Table 17 Experimental results of the hypoglycemic efficacy of the samples (n = 10)

[0286] Compared with the model control group, ***p < 0.001.

[0287] Effect Example 11 Renoprotective effect

[0288] 1. Detection materials

[0289] 1.1 Sample preparation information

[0290] The disclosed composition (prepared according to Example 1), and the solvent is standard dilution water.

[0291] Positive control: Shenshuaining Capsules, capsules, batch number 20220704, Yunnan Leiyunshang Pharmaceutical Co., Ltd., and the solvent is standard dilution water.

[0292] 1.2 Experimental animals

[0293] Zebrafish were all raised in fish-raising water at 28 °C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, the conductivity was 450 - 550 μS / cm; pH was 6.5 - 8.5; hardness was 50 - 100 mg / LCaCO3), provided by the fish-raising center of our company. The experimental animal use license number is: SYXK(Zhe)2022 - 0004, and the feeding management meets the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0294] 1.3 Instruments, consumables and reagents

[0295] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, America); Ultrasonic cleaner (JP-010T, Shenzhen Jiemeng Cleaning Equipment Co., Ltd., China); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China).

[0296] Methylcellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Aristolochic acid (batch number E2015060, Shanghai Aladdin Biochemical Technology Co., Ltd., China);

[0297] 2 Experimental Methods

[0298] Wild-type AB strain zebrafish, 2 days post-fertilization (2 dpf), were randomly selected and placed in beakers, with 30 zebrafish treated in each well (experimental group). The samples were administered in water (dosage shown in Table 18), with a positive control of 33.3 μg / mL renal failure-relieving capsules. A normal control group and a model control group were also established, with a volume of 3 mL per well. Except for the normal control group, all other experimental groups were given aristolochic acid in water to establish a zebrafish renal function injury model. After treatment at 28℃ for 2 days, each experimental group was observed under a dissecting microscope. The number of zebrafish with renal edema was counted, and the incidence of renal edema (%) in each experimental group was calculated. The statistical analysis results of this index were used to evaluate the renal function protective efficacy of the samples (incidence of renal edema). Statistical analysis was performed using SPSS software; p < 0.05 indicated a statistically significant difference.

[0299] 3 Experimental Results

[0300] Under the experimental conditions described herein, the composition exhibits renal protective effects, specifically by reducing the incidence of renal edema. See Table 18 for details.

[0301] Table 18. Experimental results of the renal protective efficacy of the samples (n=10)

[0302] Compared with the model control group, ***p<0.001.

[0303] Example 12: Effects of regulating intestinal flora

[0304] 1. Experimental Materials

[0305] 1.1. Sample Preparation Information

[0306] The composition disclosed herein (prepared according to Example 1) uses standard dilution water as the solvent.

[0307] Positive control: Bifidobacterium bifidum and Bacillus subtilis granules (Medilac-Vita), batch number 23060039, Hanmi Pharmaceutical Co., Ltd., Beijing. The solvent is standard dilution water.

[0308] 1.2. Experimental animals and bacteria

[0309] Zebrafish were all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, the conductivity was 450 - 550 μS / cm; pH was 6.5 - 8.5; hardness was 50 - 100 mg / LCaCO3). They were provided by the fish-raising center of our company. The license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management conforms to the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0310] Bifidobacterium adolescentis, BBL liquid medium, cultured anaerobically at 37°C.

[0311] 1.3. Instruments, consumables and reagents

[0312] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China); Constant temperature water bath (HH - 1, Changzhou Guohua Electric Appliance Co., Ltd., China); Constant temperature oscillator (HZ - 9211K, Taicang Hualida Experimental Equipment Co., Ltd., China); Vertical laminar flow clean bench (CA - 1390 - 1, Shanghai Shangjing Purification Equipment Co., Ltd., China); Tabletop large-capacity low-speed centrifuge (TD5A, Changsha Yingtai Instrument Co., Ltd., China); Electric focusing continuously variable magnification fluorescence microscope (AZ100, Nikon, Japan); 150 mm culture dish (050522EK01, NEST, China); Electronic turbidimeter (DensiCHEKTMPlus, bioMérieux, USA).

[0313] Methyl cellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); BBL liquid medium (batch number 20220601, Qingdao Hi-Tech Industrial Park Haibo Biotechnology Co., Ltd., China); CM-DiI (batch number 2335589, Thermo Fisher Scientific (China) Co., Ltd., China).

[0314] 2. Experimental methods

[0315] Wild-type AB strain zebrafish were randomly selected 5 days post-fertilization (5 dpf) and placed in a 150 mm petri dish. 1×10⁻⁶ g of the zebrafish was added. 8 A zebrafish gut microbiota model was established using CFU / mL red fluorescently labeled *Bifidobacterium adolescentis*. After treatment at 28℃ for 18 h, the *Bifidobacterium adolescentis* was removed, and the model zebrafish were randomly assigned to 6-well plates, with 30 zebrafish treated in each well (experimental group). Water-soluble samples (concentrations shown in Table 19) and a positive control of 2000 μg / mL *Bacillus subtilis* dual-live bacteria granules (Mommy's Love) were administered, along with a model control group (3 mL per well). After further treatment at 28℃ for 6 h, 10 zebrafish from each experimental group were randomly selected and photographed under a fluorescence microscope. Images were saved, and data were acquired using NIS-Elements D 3.20 advanced image processing software. The fluorescence intensity of *Bifidobacterium adolescentis* in the zebrafish gut was analyzed, and the statistical analysis results were used to evaluate the efficacy of the samples in regulating gut microbiota. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software, and p < 0.05 was considered statistically significant.

[0316] 3. Experimental Results

[0317] Under the experimental conditions described herein, the composition exhibits the effect of regulating intestinal flora, specifically by increasing the fluorescence intensity of Bifidobacterium adolescentis. See Table 19 for details.

[0318] Table 19. Experimental results evaluating the efficacy of samples in regulating gut microbiota (n=10)

[0319] Compared with the model control group, ***p<0.001.

[0320] Example 13: Assisted protection against gastrointestinal mucosal damage

[0321] 1. Experimental Materials

[0322] 1.1. Sample Preparation Information

[0323] The composition disclosed herein (prepared according to Example 1) uses standard dilution water as the solvent.

[0324] Positive control: Prednisone, white powder, batch number C10016501, Shanghai Maclean Biochemical Technology Co., Ltd., solvent is DMSO.

[0325] 1.2. Laboratory Animals

[0326] Zebrafish were all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, with a conductivity of 450 - 550 μS / cm; pH of 6.5 - 8.5; hardness of 50 - 100 mg / L CaCO3). They were provided by the fish-raising center of our company. The license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management complies with the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0327] 1.3. Instruments, Consumables and Reagents

[0328] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Berambo Biotechnology Co., Ltd., China); Digital horizontal decolorizing shaker (ZD-9556A, Taicang Hualida Experimental Equipment Co., Ltd., China); Electronic constant temperature water bath (HHS-2S, Shanghai Kanglu Instrument Equipment Co., Ltd., China); Microtome (KD2258, Jinhua Cody Medical Device Co., Ltd., China); Intelligent electric hot plate (400X280, Tianjin Laiyuenage Laboratory Instrument Sales Co., Ltd., China); Biological microscope (CX31, OLYMPUS, Japan).

[0329] Methylcellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Dimethyl sulfoxide (DMSO, batch number I2229063, Shanghai Aladdin Biochemical Technology Co., Ltd., China); TNBS (batch number 0000296416, Sigma, USA); Alcian blue (batch number BCBV8028, Sigma, Switzerland); 4% tissue cell fixative (batch number 240011025, Beijing Solarbio Science & Technology Co., Ltd., China); Glacial acetic acid (batch number A2425033, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Anhydrous ethanol (batch number 20241216, Sinopharm Chemical Reagent Co., Ltd., China); Xylene (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Batch No. 20240704, Sinopharm Chemical Reagent Co., Ltd., China; Hematoxylin staining solution (batch No. F2404349, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Eosin staining solution (batch No. F2404441, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Ammonia water (batch No. 20231025, Sinopharm Chemical Reagent Co., Ltd., China); Neutral resin (batch No. 20240713, Beijing Solarbio Technology Co., Ltd., China); High-efficiency slicing paraffin (melting point 54-56℃, batch No. 20230322, Shanghai Huayong Paraffin Co., Ltd., China); High-efficiency slicing paraffin (melting point 62-64℃, batch No. 20221116, Shanghai Huayong Paraffin Co., Ltd., China).

[0330] 2. Experimental Methods

[0331] 2.1 Evaluation of the efficacy of the auxiliary protective mechanism against gastrointestinal mucosal injury (number of intestinal goblet cells)

[0332] Wild-type AB strain zebrafish, 3 days post-fertilization (3 dpf), were randomly selected and encapsulated in 6-well plates, with 30 zebrafish treated in each well (experimental group). Except for the normal control group, all experimental groups were treated with TNBS (total TNBS dissolved in water) to establish a zebrafish gastrointestinal mucosal injury model. After treatment at 28℃ for 2 days, the TNBS was removed, and samples (concentrations shown in Table 20) were dissolved in water and administered. A positive control of prednisone at a concentration of 15.0 μg / mL was used. Normal and model control groups were also established, with a volume of 3 mL per well. After further treatment at 28℃ for 2 days, zebrafish in each experimental group were fixed with 4% histocellular fixative and then stained with Alcian blue. After staining, 10 zebrafish from each experimental group were randomly selected and photographed under a dissecting microscope. Images were saved, and data were collected using NIS-Elements D 3.20 advanced image processing software. The number of goblet cells in the zebrafish intestine was analyzed, and the statistical analysis results of this index were used to evaluate the efficacy of the samples in assisting the protection against gastrointestinal mucosal injury. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software, and p < 0.05 indicated that the difference was statistically significant.

[0333] 2.2. Evaluation of the efficacy of auxiliary protection against gastrointestinal mucosal injury (intestinal histopathology)

[0334] Wild-type AB strain zebrafish (3dpf) were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Except for the normal control group, all experimental groups were treated with TNBS (total nitrate-based saline) to establish a zebrafish gastrointestinal mucosal injury model. After treatment at 28℃ for 2 days, the TNBS was removed, and samples (concentrations shown in Table 20) were administered in water. A positive control of prednisone at a concentration of 15.0 μg / mL was used. Normal and model control groups were also included, with a volume of 3 mL per well. After another 2 days of treatment at 28℃, the zebrafish from each group underwent fixation, dehydration, embedding, sectioning, and H&E staining for intestinal histopathological examination to evaluate the efficacy of the samples in assisting the protection against gastrointestinal mucosal injury.

[0335] 3. Experimental Results

[0336] 3.1. Assists in protecting against gastrointestinal mucosal damage (number of intestinal goblet cells)

[0337] Under the experimental conditions described herein, the composition exhibits an auxiliary protective effect against gastrointestinal mucosal damage, specifically by increasing the number of goblet cells in the intestine. See Table 20 for details.

[0338] Table 20. Experimental results evaluating the efficacy of the samples in assisting the protection against gastrointestinal mucosal damage (n=10)

[0339] Compared with the model control group, *p<0.05, **p<0.01.

[0340] 3.2. Auxiliary efficacy in protecting against gastrointestinal mucosal injury (intestinal histopathology)

[0341] Under the conditions of this experiment, there were no obvious abnormalities in the intestines of the normal control group. The intestinal folds were obvious, the number of intestinal villi was large and their height was normal, and the intestinal epithelial cells were closely connected to the cilia and mucosa.

[0342] In the model control group, the intestinal folds decreased, the number of intestinal villi decreased and their height decreased significantly, and the intestinal lumen was significantly dilated, indicating that the model was successfully established.

[0343] In the positive control group with prednisone at a concentration of 15.0 μg / mL, the intestines were similar to those of the normal control group. The dilation of the intestinal lumen was significantly improved, and the number of intestinal folds and the number of intestinal villi increased significantly, indicating that prednisone has an auxiliary efficacy in protecting against gastrointestinal mucosal injury.

[0344] In the group with the composition of the present disclosure at a concentration of 2000 μg / mL, the intestinal lumen was significantly smaller than that of the model control group. The number of intestinal folds increased, the number and height of intestinal villi were significantly improved, and no obvious abnormalities were observed in the intestinal mucosa tissue.

[0345] Therefore, the composition of the present disclosure has an auxiliary efficacy in protecting against gastrointestinal mucosal injury.

[0346] Effect Example 14 Anti-Helicobacter pylori efficacy

[0347] 1. Experimental materials

[0348] 1.1. Sample preparation information

[0349] The composition of the present disclosure (prepared according to Example 1), with the solvent being standard dilution water.

[0350] Positive control: Clarithromycin, white powder, batch number E1529013, Shanghai Aladdin Biochemical Technology Co., Ltd. The solvent is DMSO.

[0351] 1.2. Experimental animals and bacteria

[0352] Zebrafish were all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, the conductivity was 450 - 550 μS / cm; pH was 6.5 - 8.5; hardness was 50 - 100 mg / LCaCO3). They were provided by the fish-raising center of this company. The license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0353] Helicobacter pylori culture medium (7 mL goat serum and 1 vial of Helicobacter pylori additive per 100 mL), microaerophilic, 37°C, 150 rpm shaker culture.

[0354] 1.3. Instruments, Consumables and Reagents

[0355] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Belamber Biotechnology Co., Ltd., China); Motorized focusing continuous zoom fluorescence microscope (AZ100, Nikon, Japan); Electronic turbidimeter (DensiCHEK™ Plus, bioMérieux, USA); Thermostatic water bath (HH-1, Changzhou Guohua Electric Co., Ltd., China); Thermostatic shaker (HZ-9211K, Taicang Hualida Experimental Equipment Co., Ltd., China); Vertical laminar flow clean bench (CA-1390-1, Shanghai Shangjing Purification Equipment Co., Ltd., China); Benchtop large-capacity low-speed centrifuge (TD5A, Changsha Yingtai Instrument Co., Ltd., China).

[0356] Methylcellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Helicobacter pylori culture medium (liquid) (batch number 20230823, Qingdao High-tech Industrial Park Haibo Biotechnology Co., Ltd., China); goat serum (batch number A228250304, Beyotime, China); Helicobacter pylori additive (batch number 20241210, Qingdao High-tech Industrial Park Haibo Biotechnology Co., Ltd., China); CM-DiI (batch number 2335589, Thermo Fisher Scientific (China) Co., Ltd., China).

[0357] 2. Experimental Methods

[0358] Wild-type AB strain zebrafish, 3 days post-fertilization (3 dpf), were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). Samples were administered via water-soluble solution (concentrations shown in Table 21), with clarithromycin at a positive control concentration of 125 μg / mL. A model control group was also included. Each well contained 3 mL of solution. After treatment at 28℃ for 2 days, 5 × 10⁻⁶ zebrafish were added to all groups. 7Helicobacter pylori labeled with red fluorescence at CFU / mL was used to establish a zebrafish Helicobacter pylori infection model. After continuing the treatment at 28°C for 1 day, 10 zebrafish were randomly selected from each group, photographed under a fluorescence microscope, and the pictures were saved. The NIS-Elements D 3.20 advanced image processing software was used to collect data, and the fluorescence intensity of Helicobacter pylori in the zebrafish intestine was analyzed. The anti-Helicobacter pylori efficacy of the sample was evaluated based on the statistical results of this index. The statistical processing results were expressed as mean±SE. Statistical analysis was performed using SPSS software, and p<0.05 indicated that the difference was statistically significant.

[0359] 3. Experimental results

[0360] Under the conditions of this experiment, the disclosed composition has anti-Helicobacter pylori efficacy, specifically manifested as reducing the fluorescence intensity of Helicobacter pylori in the intestine. See Table 21 for details.

[0361] Table 21 Experimental results of the anti-Helicobacter pylori efficacy evaluation of the sample (n = 10)

[0362] Compared with the model control group, **p<0.01, ***p<0.001.

[0363] Evaluation of the efficacy of Example 15 in improving spleen-yang deficiency

[0364] 1. Experimental materials

[0365] 1.1 Sample preparation information

[0366] The disclosed composition (prepared according to Example 1), and the solvent is standard dilution water.

[0367] Positive control: Alpinia officinarum, yellowish-brown solid, and the solvent is standard dilution water.

[0368] 1.2 Experimental animals

[0369] Zebrafish were all raised in fish-raising water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, the conductivity was 450 - 550 μS / cm; pH was 6.5 - 8.5; hardness was 50 - 100 mg / LCaCO3). They were provided by the company's fish-raising center. The license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC certification (certification number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0370] 1.3 Instruments, consumables and reagents

[0371] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); motorized focusing continuous zoom fluorescence microscope (AZ100, Nikon, Japan); precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China); 150mm petri dish (050522EK01, NEST, China).

[0372] Methylcellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Senna leaf (batch number 2022110456, Anhui Shenghaitang, China).

[0373] 2 Experimental Methods

[0374] Four-day-old (4 dpf) transgenic MPX strain zebrafish were randomly selected and placed in culture dishes. A zebrafish model of spleen-yang deficiency was established by administering senna leaf solution. After treatment at 28℃ for 24 h, the senna leaf was removed, and the model zebrafish were transferred to new culture dishes. A normal control group was also included. After feeding at 28℃ for 3 h, the zebrafish were divided into 6-well plates, with 30 zebrafish per well (experimental group). The sample (concentration shown in Table 22) was administered in water. A normal control group and a model control group were also included. The positive control, galangal (25.0 μg / mL), was administered in 3 mL wells. After another 24 h of treatment at 28℃, 10 zebrafish from each experimental group were randomly selected and photographed under a fluorescence microscope. Data were collected using NIS-Elements D 3.20 advanced image processing software to analyze the number of neutrophils in the zebrafish intestinal lumen. The statistical analysis results of this index were used to evaluate the efficacy of the sample in improving spleen-yang deficiency. Statistical results are expressed as mean ± SE. Statistical analysis using SPSS software showed that p < 0.05 was statistically significant.

[0375] 3 Experimental Results

[0376] Under the experimental conditions described herein, the composition exhibits the effect of improving spleen-yang deficiency, specifically by reducing the number of neutrophils in the intestinal lumen. See Table 22 for details.

[0377] Table 22. Experimental results evaluating the efficacy of the samples in improving spleen-yang deficiency (n=10)

[0378] Compared with the model control group, ***p<0.001.

[0379] Example 16 Embryotoxicity Evaluation

[0380] 1. Experimental Materials

[0381] 1.1 Sample preparation information

[0382] The disclosed composition (prepared according to Example 1) has a solvent of standard dilution water.

[0383] Positive control: 3,4-dichloroaniline, CAS No. 95-76-1, Shanghai Aladdin Biochemical Technology Co., Ltd., with a solvent of DMSO.

[0384] 1.2 Experimental animals

[0385] Zebrafish are all raised in fish culture water at 28°C (water quality: 200 mg of instant sea salt is added to every 1 L of reverse osmosis water, with a conductivity of 450 - 550 μS / cm; pH of 6.5 - 8.5; hardness of 50 - 100 mg / LCaCO3). They are provided by the company's fish culture center. The license number for the use of experimental animals is: SYXK(Zhe)2022 - 0004. The feeding management meets the requirements of international AAALAC accreditation (accreditation number: 001458), and the IACUC ethical review number is: IACUC - 2025 - 202509030009 - 01.

[0386] 1.3 Instruments, consumables and reagents

[0387] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); Precision electronic balance (CP214, OHAUS, USA); 24-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China).

[0388] 2 Experimental methods

[0389] Randomly select wild-type AB strain zebrafish at 6 hours post-fertilization (6hpf) into 24-well plates, with 1 zebrafish per well and 10 wells per experimental group. The sample is administered in water solution (concentration shown in Table 23), and the positive control 3,4-dichloroaniline is at 3.70 mg / L. At the same time, a normal control group and an inter-plate control group are set up, with a volume of 1 mL per well. Treat at 28°C, observe the embryonic state every 24 hours and record. After 48 hours, count the mortality and toxic phenotypes of zebrafish in each group, and evaluate the embryonic toxicity of the sample based on the statistical analysis results of this index.

[0390] 3 Experimental results

[0391] Under the experimental conditions, all zebrafish died at a concentration of 4000 μg / mL of the disclosed composition, and no zebrafish died and no toxic phenotypes were observed at 2000 μg / mL. The maximum safe concentration of the disclosed composition is 2000 μg / mL. See Table 23 for details.

[0392] Table 23 Results of embryotoxicity evaluation experiments (interplate control n=4, others n=10)

[0393] 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. The application of a food-medicine homology composition in the preparation of a drug for treating alcoholic fatty liver, wherein the food-medicine homology composition is made from the following raw materials in parts by weight: 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 use of the food-medicine homology composition as described in claim 1 in the preparation of a medicament for treating chemically induced liver injury.

3. The use of the food-medicine homology composition as described in claim 1 in the preparation of a drug with uric acid-lowering effect.

4. The use of the food-medicine homology composition as described in claim 1 in the preparation of medicaments for antiviral pneumonia and / or antibacterial pneumonia.

5. The use of the food-medicine homology composition as described in claim 1 in the preparation of a drug for enhancing immunity.

6. The use of the food-medicine homology composition as described in claim 1 in the preparation of a medicament for improving sleep.

7. The use of the food-medicine homology composition as described in claim 1 in the preparation of lipid-lowering drugs.

8. The use of the food-medicine homology composition as described in claim 1 in the preparation of a hypoglycemic drug.

9. The use of the food-medicine homology composition as described in claim 1 in the preparation of a drug with renal protective effects.

10. The use of the food-medicine homology composition as described in claim 1 in the preparation of a drug for regulating intestinal flora.

11. The use of the food-medicine homology composition as described in claim 1 in the preparation of a medicament for improving Helicobacter pylori infection-related diseases.

12. The application as described in claim 11, characterized in that, The application is the use of food-medicine homology compositions in the preparation of drugs that improve precancerous lesions of the stomach.

13. The application as described in claim 12, characterized in that, The precancerous lesions of the stomach include at least one of chronic atrophic gastritis, intestinal metaplasia, and low-grade intraepithelial neoplasia.

14. The application as described in claim 11, characterized in that, The application is the use of the food-medicine homology composition in the preparation of drugs to improve gastric mucosal damage.

15. The application as described in any one of claims 1-14, 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.

16. The application as described in any one of claims 1-14, characterized in that, The preparation method of the medicinal and edible homology composition 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.

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