A nourishing powder and a preparation method thereof

Abstract

This invention discloses a nourishing powder and its preparation method, belonging to the field of food and health product technology. The nourishing powder is made from the following raw materials in weight percentages: Codonopsis pilosula 3%–5%, Poria cocos 10%–15%, lotus seeds (without the heart) 10%–15%, Dioscorea opposita 10%–15%, Euryale ferox 10%–15%, Coix lacryma-jobi 25%–30%, japonica rice 10%–15%, fresh malt 15%–30%, and edible gypsum powder 2%–3%. The preparation method includes: processing the Codonopsis pilosula and other medicinal materials into coarse powder; cooking japonica rice and diluting it into porridge; processing malt and edible gypsum powder into a paste and mixing it with the porridge; adding the coarse powdered medicinal materials and soaking until the liquid is absorbed; steaming, drying, and pulverizing to obtain the final product. The formulation of this invention focuses on invigorating qi, strengthening the spleen, and removing dampness. It has a mild medicinal property, a pleasant taste, and functions to improve immunity, promote appetite, remove dampness and relieve constipation, and regulate gastrointestinal function. Furthermore, the unique preparation method effectively preserves the active ingredients of the raw materials.

Description

Technical Field

[0001] This invention belongs to the field of food and health product technology, and in particular relates to a nourishing powder and its preparation method. Background Technology

[0002] Yangyuan powder, a traditional health food, focuses on nourishing the spleen and stomach and has a long history of use in my country. The spleen and stomach are the foundation of acquired health and the source of qi and blood; dysfunction of the spleen and stomach can lead to various illnesses. Due to factors such as irregular diet and lifestyle, many people in modern society suffer from weak spleen and stomach and internal dampness. Therefore, developing safe, effective, and long-term suitable spleen-strengthening and qi-nourishing foods is of significant practical importance.

[0003] Currently, there are several food or health products on the market that claim to invigorate the spleen, dispel dampness, nourish vital energy, and replenish qi. For example, a spleen-invigorating "Eight Treasures Cake" contains ingredients such as Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, Dioscorea opposita, Euryale ferox, lotus seeds, and rice, and is made through processes including extraction, grinding, chopping, molding, and drying. Another health-promoting combination for nourishing the spleen and stomach contains ingredients such as chicken gizzard lining, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi, lotus seeds, Euryale ferox, and Dioscorea opposita, and uses low-temperature ultra-micro cell wall breaking technology to process the raw materials. In addition, there are also traditional Chinese medicine combinations for invigorating the spleen and dispelling dampness, made into oral preparations using ingredients such as Coix lacryma-jobi, red adzuki beans, Euryale ferox, Dioscorea opposita, and bitter almonds.

[0004] However, the aforementioned existing technologies still have the following shortcomings: Firstly, existing product formulations are either too simplistic or involve complex medications, lacking specificity and failing to accurately reflect the core TCM concept of "emphasizing postnatal spleen and stomach conditioning." While some products also possess spleen-strengthening and dampness-removing effects, their formulation design lacks systematicity, making it difficult to achieve a synergistic effect of invigorating qi, strengthening the spleen, and removing dampness.

[0005] Secondly, the existing processing methods for these products are relatively simple, often involving direct crushing, mixing, or conventional extraction. They do not pay enough attention to the pretreatment and fermentation of raw materials, making it difficult to fully stimulate the medicinal and edible activities of the raw materials and affecting the efficacy and taste of the final product.

[0006] Third, although some products contain medicinal and edible herbs in their formulations, they do not fully consider the mildness of the medicinal properties and the suitability of the taste, resulting in poor long-term compliance and limiting their promotion as daily health foods.

[0007] To address the shortcomings of the existing technologies, this invention provides a nourishing powder and its preparation method. This nourishing powder formula integrates the essence of traditional Chinese medicine, with tonifying qi, strengthening the spleen, and dispelling dampness as its core. It selects medicinal and edible herbs, resulting in a mild medicinal effect and pleasant taste. Furthermore, this invention employs a unique "porridge-malt paste fermentation" process, using temperature-controlled fermentation to ensure full interaction of the raw materials, effectively enhancing the product's efficacy and taste. This invention aims to provide the market with a well-formulated, meticulously prepared, widely applicable, and effective spleen-strengthening and nourishing food product. Summary of the Invention

[0008] The purpose of this invention is to provide a nutrient powder and its preparation method, which can completely solve the shortcomings of the prior art.

[0009] The objective of this invention is achieved through the following technical solution: A method for preparing a nourishing powder includes the following steps: (1) Weigh the following raw materials by weight percentage: Codonopsis pilosula 3%–5%, Poria cocos 10%–15%, lotus seeds (without heart) 10%–15%, Dioscorea opposita 10%–15%, Euryale ferox 10%–15%, Coix lacryma-jobi 25%–30%, japonica rice 10%–15%, fresh malt 15%–30%, and edible gypsum powder 2%–3%; (2) Process Codonopsis pilosula, Poria cocos, lotus seeds (without the core), Dioscorea opposita, Euryale ferox, and Coix lacryma-jobi into coarse powder for later use; (3) Cook the japonica rice into rice, and mix the fresh malt with edible gypsum powder to make a paste, thus obtaining malt paste; (4) Dilute the rice described in step (3) with water to make porridge, and control the temperature of the porridge to be 45℃~60℃; (5) Mix the malt paste from step (3) with the porridge from step (4) and let it soak at room temperature for 2 to 4 hours until the rice becomes a paste to obtain the first soaking mixture; (6) Add the coarse powder from step (2) to the first foaming compound from step (5) and soak for 2-3 hours until the broth is absorbed to obtain the second foaming compound; (7) Steam the second foamed compound from step (6) until it is cooked, dry it until the moisture content is qualified, and then pulverize it into fine powder to obtain Yangyuan powder.

[0010] Preferably, the temperature of the porridge in step (4) is controlled at 45℃~55℃ in spring and summer, and at 55℃~60℃ in autumn and winter.

[0011] Preferably, the soaking time in step (5) is controlled as follows: 2-3 hours in spring and autumn, and 3-4 hours in summer and winter.

[0012] Preferably, the drying in step (7) is constant temperature drying.

[0013] Preferably, the raw materials are in the following weight percentages: Codonopsis pilosula 4%, Poria cocos 12%, lotus seeds (without the core) 12%, Dioscorea opposita 12%, Euryale ferox 12%, Coix lacryma-jobi 28%, japonica rice 12%, fresh malt 20%, and edible gypsum powder 2%.

[0014] The Yangyuan powder prepared by any of the above preparation methods.

[0015] The application of the aforementioned Yangyuan powder in the preparation of food or health products with the effects of invigorating qi, strengthening the spleen, and removing dampness.

[0016] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The formula is precise and the efficacy is clear. This invention is formulated based on the traditional Chinese medicine concept of "emphasizing postnatal spleen and stomach conditioning," with the core principle of invigorating qi, strengthening the spleen, and eliminating dampness. It utilizes carefully selected medicinal and edible herbs such as Codonopsis pilosula, Poria cocos, lotus seeds (without the heart), Dioscorea opposita, Euryale ferox, Coix lacryma-jobi, japonica rice, and malt. In this formula, Codonopsis pilosula, Dioscorea opposita, and japonica rice nourish the qi and yin of the spleen and stomach; Poria cocos, lotus seeds, Euryale ferox, and Coix lacryma-jobi eliminate dampness and strengthen the spleen; and malt promotes qi circulation, aids digestion, and strengthens the spleen and stomach. The entire formula works synergistically to invigorate qi, strengthen the spleen, and eliminate dampness, showing significant effects in improving symptoms such as loss of appetite, fatigue, and loose or sticky stools caused by spleen and stomach weakness and internal dampness retention.

[0017] 2. The preparation method is unique, and the active ingredients are fully preserved.

[0018] This invention employs a unique "porridge-malt paste fermentation" process. Utilizing the abundant amylase and other active ingredients in fresh malt, it is fermented with porridge under controlled temperature conditions, allowing the rice starch to fully saccharify and transform, producing small-molecule sugars and flavor compounds. This not only improves the product's taste and digestibility but also lowers the glycemic index. Subsequently, coarsely ground medicinal herbs are added for a second fermentation, allowing the herbs to fully absorb the nutrients in the broth and achieving deep integration of the ingredients. Finally, the mixture is steamed, dried, and pulverized into a powder, effectively preserving the active components of each ingredient.

[0019] 3. It has mild medicinal properties, a pleasant taste, and is suitable for a wide range of people.

[0020] The raw materials selected for this invention are all medicinal and edible products, ensuring high safety, mild medicinal properties, pleasant taste, and no unpleasant odor, making them suitable for long-term use. Unlike some existing products that use complex or unbalanced medicinal ingredients, this invention's formula fully conforms to the category of medicinal and edible products, making it suitable for a wide range of people and meeting the daily health maintenance needs of people of different ages.

[0021] 4. Strict processing and preparation methods ensure stable quality.

[0022] This invention imposes strict requirements on the processing of raw materials. From raw material pretreatment, temperature control during soaking, steaming to drying and pulverizing, each step has clearly defined process parameters to ensure product quality stability and batch-to-batch consistency. The constant-temperature drying method avoids the damage of high temperatures to active ingredients, further guaranteeing product efficacy. Detailed Implementation

[0023] Exemplary embodiments of the present disclosure will now be described in more detail. These embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0024] A method for preparing a nourishing powder includes the following steps: (1) Weigh the following raw materials by weight percentage: Codonopsis pilosula 3%–5%, Poria cocos 10%–15%, lotus seeds (without heart) 10%–15%, Dioscorea opposita 10%–15%, Euryale ferox 10%–15%, Coix lacryma-jobi 25%–30%, japonica rice 10%–15%, fresh malt 15%–30%, and edible gypsum powder 2%–3%; (2) Process Codonopsis pilosula, Poria cocos, lotus seeds (without the core), Dioscorea opposita, Euryale ferox, and Coix lacryma-jobi into coarse powder for later use; (3) Cook the japonica rice into rice, and mix the fresh malt with edible gypsum powder to make a paste, thus obtaining malt paste; (4) Dilute the rice described in step (3) with water to make porridge, and control the temperature of the porridge to be 45℃~60℃; (5) Mix the malt paste from step (3) with the porridge from step (4) and let it soak at room temperature for 2 to 4 hours until the rice becomes a paste to obtain the first soaking mixture; (6) Add the coarse powder from step (2) to the first foaming compound from step (5) and soak for 2-3 hours until the broth is absorbed to obtain the second foaming compound; (7) Steam the second foamed compound from step (6) until it is cooked, dry it until the moisture content is qualified, and then pulverize it into fine powder to obtain Yangyuan powder.

[0025] The temperature control of the porridge in step (4) is as follows: 45℃~55℃ in spring and summer, and 55℃~60℃ in autumn and winter.

[0026] The soaking time in step (5) is controlled as follows: 2-3 hours in spring and autumn, and 3-4 hours in summer and winter.

[0027] The drying process described in step (7) is constant temperature drying.

[0028] The weight percentages of the raw materials are as follows: Codonopsis pilosula 4%, Poria cocos 12%, lotus seeds (without the core) 12%, Dioscorea opposita 12%, Euryale ferox 12%, Coix lacryma-jobi 28%, japonica rice 12%, fresh malt 20%, and edible gypsum powder 2%.

[0029] The Yangyuan powder prepared by any of the above preparation methods.

[0030] The application of the aforementioned Yangyuan powder in the preparation of food or health products with the effects of invigorating qi, strengthening the spleen, and removing dampness.

[0031] I. Raw Material Composition of Yangyuan Powder

[0032] The nourishing powder of this invention is made from the following raw materials in weight percentages: Table 1. Raw material composition of Yangyuan powder (by weight percentage)

[0033] All of the above-mentioned raw materials are medicinal and edible materials, which meet the relevant standards of the Pharmacopoeia of the People's Republic of China, are safe and reliable, and are suitable for long-term use.

[0034] II. Preparation method of Yangyuan powder

[0035] The preparation method of the Yangyuan powder of the present invention includes the following steps: (a) Raw material pretreatment Weigh each ingredient according to the above weight percentages. Remove impurities from Codonopsis pilosula, Poria cocos, lotus seeds (without the core), Dioscorea opposita, Euryale ferox, and Coix lacryma-jobi, then process them into coarse powder (particle size of about 2-5 mm), mix them evenly, and set aside.

[0036] Wash the rice thoroughly and set aside. Take fresh malt, remove any impurities, and set aside.

[0037] (II) Rice preparation and dilution

[0038] Cook the thoroughly rinsed rice using the usual method. Add an appropriate amount of water to the cooked rice to dilute it into a porridge consistency. Control the temperature of the porridge, adjusting it according to the season: maintain 45℃~55℃ in spring and summer, and 55℃~60℃ in autumn and winter.

[0039] (III) Preparation of maltodextrin

[0040] Fresh malt is mixed with edible gypsum powder and processed into a paste to obtain malt paste.

[0041] (iv) First mixing (porridge-malt paste mixing)

[0042] Mix the maltodextrin with the temperature-controlled porridge and stir thoroughly. Allow it to soak at room temperature, adjusting the soaking time according to the season: 3-4 hours in summer, 2-3 hours in spring and autumn, and 3-4 hours in winter. The soaking should continue until the rice is fully gelatinized, yielding the first soaked mixture.

[0043] (v) Second soaking (adding the medicine powder for soaking)

[0044] Add the coarse powder of medicinal materials obtained in step (1) to the first soaking mixture, stir thoroughly, and continue soaking for 2-3 hours. The mixture should be soaked until the liquid is fully absorbed by the coarse powder of medicinal materials to obtain the second soaking mixture.

[0045] (vi) Steaming and drying

[0046] The second foamed compound is placed in a steaming device and steamed until cooked. The cooked material is then dried, preferably using a constant temperature drying method, until the moisture content meets the requirements (usually ≤8%). The dried material is then pulverized into fine powder (particle size ≤150μm) to obtain the Yangyuan powder product.

[0047] III. Optimization of Key Process Parameters in the Preparation Method

[0048] 1. Temperature control of porridge

[0049] The temperature of the porridge is one of the key parameters in the preparation method of this invention. Excessive temperature will deactivate the active ingredients in the malt (such as amylase), affecting the saccharification and conversion of starch during the fermentation process; excessively low temperature will reduce the fermentation reaction rate, making it difficult to complete gelatinization within a reasonable time. This invention sets different temperature ranges according to seasonal temperature differences: 45℃~55℃ in spring and summer (higher temperatures), and 55℃~60℃ in autumn and winter (lower temperatures), ensuring both enzyme activity and efficient fermentation.

[0050] 2. Control of soaking time

[0051] Soaking time is also a key parameter. The first soaking time (mixing malt paste with porridge) is 2-4 hours, allowing the amylase in the malt to fully act on the starch in the porridge, converting it into small-molecule sugars and producing unique flavor compounds. The second soaking time (adding coarsely ground medicinal herbs) is 2-3 hours, allowing the herbs to fully absorb the nutrients in the broth and achieve deep integration between the ingredients.

[0052] 3. Uses of edible gypsum powder

[0053] In this invention, edible gypsum powder is used as a processing aid, which is processed together with fresh malt into a paste. This helps to adjust the texture and pH value of the malt paste, creating a suitable microenvironment for the subsequent blistering reaction.

[0054] IV. Efficacy and Mechanism of Yangyuan Powder

[0055] The nourishing powder of this invention has the effects of invigorating qi, strengthening the spleen, and removing dampness, specifically manifested in improving immunity, promoting appetite, removing dampness and relieving constipation, and regulating gastrointestinal function.

[0056] Its working principle is as follows: Codonopsis pilosula: It has a sweet taste and neutral properties, and enters the spleen and lung meridians. It has the effects of tonifying the middle energizer and replenishing qi, strengthening the spleen and benefiting the lungs. Modern research shows that Codonopsis pilosula is rich in polysaccharides, saponins and other components, which can enhance immunity and regulate gastrointestinal motility.

[0057] Chinese yam (Dioscorea opposita): It has a sweet taste and neutral properties, and enters the spleen, lung, and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence. It is rich in mucoprotein, amylase, etc., which helps with digestion and absorption.

[0058] Japonica rice: It is sweet and neutral in nature, and enters the spleen and stomach meridians. It has the effects of replenishing qi and strengthening the spleen and stomach, and is a good product for nourishing the stomach.

[0059] The three ingredients mentioned above, which are both food and medicine, work together to nourish the spleen and stomach, replenishing their qi and yin.

[0060] Poria cocos: It has a sweet and bland taste and a neutral nature. It enters the heart, lung, spleen and kidney meridians and has the effects of promoting diuresis and removing dampness, strengthening the spleen and calming the mind.

[0061] Lotus seeds with the core removed: They are sweet and astringent in taste and neutral in nature. They enter the spleen, kidney, and heart meridians and have the effects of tonifying the spleen and stopping diarrhea, benefiting the kidneys and astringing essence, and nourishing the heart and calming the mind.

[0062] Euryale ferox: It has a sweet and astringent taste and a neutral nature. It enters the spleen and kidney meridians and has the effects of tonifying the kidney and consolidating essence, strengthening the spleen and stopping diarrhea, and eliminating dampness and stopping leukorrhea.

[0063] Job's tears: It has a sweet and bland taste and a cool nature. It enters the spleen, stomach and lung meridians and has the effects of promoting diuresis and removing dampness, strengthening the spleen and stopping diarrhea, and relieving numbness and draining pus.

[0064] The above four medicinal herbs work together to dispel dampness and strengthen the spleen, and their medicinal properties are mild, complementing each other.

[0065] Malt: It has a sweet taste and neutral properties, and enters the spleen and stomach meridians. It has the effects of promoting qi circulation, aiding digestion, and strengthening the spleen and stomach. Fresh malt is rich in active ingredients such as amylase and B vitamins, which serve as both active ingredients and fermentation medium to promote the transformation of raw materials in this invention.

[0066] Edible gypsum powder: In this invention, it is used as a processing aid to assist in the preparation and foaming process of maltodextrin.

[0067] The entire formula focuses on "tonifying qi, strengthening the spleen, and eliminating dampness," while also nourishing the qi and yin of the spleen and stomach. The formula is concise yet its efficacy is clear. All ingredients are food and medicine homologous, ensuring high safety and suitability for long-term use.

[0068] V. Methods and dosage of taking Yangyuan powder

[0069] This invention's nourishing powder is in powder form and can be mixed with warm water to form a paste before consumption. The recommended dosage is 10-15 grams (based on dry powder) twice a day, morning and evening.

[0070] VI. Representative Examples of the Preparation Method of the Invention

[0071] Example 1

[0072] Weigh the following ingredients by weight percentage: Codonopsis pilosula 4%, Poria cocos 12%, lotus seeds (without the heart) 12%, Dioscorea opposita 12%, Euryale ferox 12%, Coix lacryma-jobi 28%, japonica rice 12%, fresh malt 20%, and edible gypsum powder 2%.

[0073] Codonopsis pilosula, Poria cocos, lotus seeds (without the core), Dioscorea opposita, Euryale ferox, and Coix lacryma-jobi are coarsely ground. Rice is cooked and diluted with water to make a thin porridge, maintaining a temperature of 50℃ (in spring). Fresh malt and gypsum powder are processed into a paste and mixed with the porridge, then left to soak at room temperature for 2.5 hours until the rice becomes a paste. The coarsely ground medicinal herbs are added, and the mixture is left to soak for another 2.5 hours until the liquid is absorbed. After steaming, the mixture is dried at a constant temperature and then ground into a fine powder to obtain the nourishing powder.

[0074] Example 2

[0075] Weigh the following ingredients by weight percentage: Codonopsis pilosula 3%, Poria cocos 15%, lotus seeds (without the heart) 10%, Dioscorea opposita 10%, Euryale ferox 10%, Coix lacryma-jobi 25%, japonica rice 10%, fresh malt 15%, and edible gypsum powder 2%.

[0076] Codonopsis pilosula, Poria cocos, lotus seeds (without the core), Dioscorea opposita, Euryale ferox, and Coix lacryma-jobi are coarsely ground. Rice is cooked and diluted with water to make a thin porridge, maintaining a temperature of 58℃ (in winter). Fresh malt and gypsum powder are processed into a paste and mixed with the porridge, then left to soak at room temperature for 3.5 hours until the rice becomes a paste. The coarsely ground medicinal herbs are added, and the mixture is left to soak for another 2 hours until the liquid is absorbed. After steaming, the mixture is dried at a constant temperature and then ground into a fine powder to obtain the nourishing powder.

[0077] Example 3

[0078] Weigh the following ingredients by weight percentage: Codonopsis pilosula 5%, Poria cocos 10%, lotus seeds (without the heart) 15%, Dioscorea opposita 10%, Euryale ferox 15%, Coix lacryma-jobi 30%, japonica rice 12%, fresh malt 28%, and edible gypsum powder 3%.

[0079] Codonopsis pilosula, Poria cocos, lotus seeds (without the core), Dioscorea opposita, Euryale ferox, and Coix lacryma-jobi are coarsely ground. Rice is cooked and diluted with water to make a thin porridge, maintaining a temperature of 48℃ (in summer). Fresh malt and gypsum powder are processed into a paste and mixed with the porridge, then left to soak at room temperature for 3.5 hours until the rice becomes a paste. The coarsely ground medicinal herbs are added, and the mixture is left to soak for another 3 hours until the liquid is absorbed. After steaming, the mixture is dried at a constant temperature and then ground into a fine powder to obtain the nourishing powder.

[0080] VII. Pharmacodynamic Experiments

[0081] To verify the efficacy of the Yangyuan powder of this invention, the inventors conducted systematic pharmacodynamic experiments, including in vitro experiments, animal experiments, and clinical observations.

[0082] (I) In vitro experiment: Effect of Yangyuan powder on pepsin activity

[0083] 1. Experimental Objective

[0084] The effect of Yangyuan powder on pepsin activity in an in vitro simulated gastric juice environment was observed to evaluate its direct promoting effect on protein digestion.

[0085] 2. Experimental Materials

[0086] Test drug: Yangyuan powder prepared according to Example 1 of this invention was dissolved in distilled water to form suspensions of different concentrations (mass concentrations of 0.5%, 1.0%, 2.0%, and 4.0%, respectively). The suspensions were sonicated for 15 minutes, centrifuged at 12000 r / min for 15 minutes at 4°C, and the supernatant was collected and filtered through a 0.22 μm microporous membrane for sterilization. Simultaneously, blank control solutions of corresponding concentrations were prepared (i.e., without the addition of pepsin, with the other procedures the same) to subtract the background colorimetric properties of the drug itself.

[0087] Positive control drug: Multienzyme tablets (commercially available), crushed and prepared into a 2.0% suspension with distilled water, and the supernatant was obtained by the same method.

[0088] Blank control group: an equal volume of distilled water.

[0089] Substrate: Bovine hemoglobin (Sigma-Aldrich, USA), prepared as a 2.0% protein solution with 0.1 mol / L hydrochloric acid solution and adjusted to pH 2.0.

[0090] Pepsin: Pepsin standard (Sigma-Aldrich, USA, enzyme activity 1:3000) was prepared into a 0.1% enzyme solution with 0.1 mol / L hydrochloric acid solution.

[0091] 3. Experimental Methods

[0092] Pepsin activity was determined using a modified Anson's hemoglobin digestion method. The total reaction volume was 5 mL, comprising: 2 mL substrate solution, 0.5 mL pepsin solution, 1 mL of test drug solution or control solution of different concentrations, and 0.1 mol / L hydrochloric acid buffer (pH 2.0) to a final volume of 5 mL. After mixing, the mixture was incubated in a 37°C water bath for 30 minutes. Immediately after incubation, 2.5 mL of 10% trichloroacetic acid solution was added to terminate the reaction. The mixture was thoroughly mixed, allowed to stand for 10 minutes, and then centrifuged at 3000 rpm for 15 minutes at 4°C. The supernatant was collected.

[0093] The free tyrosine content in the supernatant was determined using the ninhydrin colorimetric method: 1 mL of supernatant was added to 2 mL of ninhydrin colorimetric solution (0.2% ninhydrin-ethanol solution mixed with an equal volume of acetate buffer), heated in a boiling water bath for 15 minutes, and the absorbance (OD) was measured at 570 nm after cooling. A corresponding drug blank control (without pepsin) was set up in each well. The final enzyme activity value was calculated as: OD value of the enzyme-containing tube - OD value of the corresponding drug blank tube, to eliminate interference from the drug's own colorimetric reaction. Each group had 5 replicates, independently repeated 3 times.

[0094] Enzyme activity unit definition: Under the above conditions, the amount of enzyme that catalyzes the production of 1 μg of tyrosine per minute is defined as 1 activity unit (U).

[0095] 4. Experimental Results

[0096] Note: All data have had their background levels adjusted for the corresponding drug concentrations; compared with the blank control group, P<0.05. P<0.01; data are expressed as Mean±SD.

[0097] 5. Experimental Conclusions

[0098] After adjusting for the background color of the drug itself, Yangyuan powder significantly enhanced the digestive activity of pepsin on hemoglobin within the concentration range of 0.5% to 4.0%, showing a clear dose-response relationship. The promotion rate in the 2.0% concentration group was 43.0%, higher than that of the positive control drug multi-enzyme tablets at the same concentration (39.2%), indicating that Yangyuan powder has a good in vitro digestive aid effect.

[0099] (ii) Animal experiments

[0100] Experiment 1: Effects of Yangyuan Powder on Gastrointestinal Motility in Spleen-Deficient Mice

[0101] 1. Experimental Objective

[0102] Using a reserpine-induced spleen deficiency mouse model, the effects of Yangyuan powder on gastric emptying rate and intestinal propulsion rate in mice were observed to evaluate its efficacy in strengthening the spleen and promoting digestion.

[0103] 2. Experimental Materials

[0104] Experimental animals: 80 SPF-grade Kunming mice (60 mice were actually enrolled, with 20 reserved for replacements in case of model failure or death), half male and half female, weighing 18-22g. They were acclimatized for 1 week, with free access to water and food, room temperature (22±2)℃, relative humidity (55±5)%, and 12h light-dark cycle.

[0105] Test drug: Yangyuan powder prepared according to Example 1 of the present invention, which is prepared into a suspension of the corresponding concentration with distilled water for gavage.

[0106] Positive control drug: Shenling Baizhu Powder (commercially available), prepared as a suspension with distilled water.

[0107] Modeling agent: Reserpine injection (1 mg / mL).

[0108] Reagents: Activated charcoal, gum arabic, physiological saline.

[0109] 3. Animal grouping and dosing regimen

[0110] Sixty mice were randomly divided into six groups of ten each, with half males and half females:

[0111] 4. Experimental Methods

[0112] (1) Establishment of a spleen deficiency model

[0113] Except for the normal control group, mice in the other groups were subcutaneously injected with reserpine 0.3 mg / kg every morning for 14 consecutive days to establish a spleen deficiency syndrome model. During the modeling period, the general condition of the mice (mental state, activity level, coat color, fecal characteristics, weight changes, etc.) was observed daily. During the modeling process, 4 mice (approximately 6.7%) in the model group and the drug treatment group died due to extreme weakness. A few other mice exhibited atypical modeling symptoms and were randomly replaced from reserve mice to ensure that each group ultimately maintained 10 effective samples. After the modeling was completed, all surviving mice in each group showed varying degrees of lethargy, arched backs, sallow coat, and loose stools, indicating that the spleen deficiency model was successfully established.

[0114] (2) Drug intervention

[0115] After the modeling was completed, each drug administration group was given the corresponding drug by gavage according to the above protocol, while the normal control group and the model control group were given an equal volume of physiological saline once a day for 14 consecutive days.

[0116] (3) Measurement of gastric emptying rate and intestinal propulsion rate

[0117] Two hours after the last administration, mice in each group were administered 0.5 mL of a semi-solid paste (2% activated charcoal + 10% gum arabic + distilled water) by gavage. Twenty minutes later, the mice were sacrificed, and the intact gastrointestinal tract was removed via laparotomy. The total distance from the pylorus to the ileocecal junction and the distance advanced by the front edge of the activated charcoal paste were measured, and the intestinal propulsion rate was calculated. Intestinal propulsion rate (%) = (distance propelled by the leading edge of the charcoal powder / total length of the small intestine) × 100% After weighing the stomach, it is cut open along the greater curvature, the contents are flushed out with saline, and after drying, the net weight of the stomach is weighed. The gastric emptying rate is then calculated. Gastric emptying rate (%) = [1 - (total stomach weight - net stomach weight) / weight of semi-solid paste administered via gavage] × 100% 5. Experimental Results

[0118] Note: Compared with the normal control group, P<0.01; compared with the model control group, #P<0.05, ##P<0.01; data are expressed as Mean±SD.

[0119] 6. Experimental Conclusions

[0120] The gastric emptying rate and intestinal propulsion rate of the model control group mice were significantly lower than those of the normal control group (P<0.01), indicating that the spleen deficiency model was successfully established. After intervention with Yangyuan powder, the gastric emptying rate and intestinal propulsion rate of mice in each dosage group were improved to varying degrees. Among them, the medium and high dosage groups showed statistically significant differences compared with the model control group (P<0.01), and the high dosage group was more effective than the positive control group. The results indicate that Yangyuan powder can significantly improve the gastrointestinal motility function of spleen-deficient mice and has the effect of strengthening the spleen and promoting digestion.

[0121] Experiment 2: Effects of Yangyuan Powder on Non-specific Immune Function in Immunosuppressed Mice

[0122] 1. Experimental Objective

[0123] Using a cyclophosphamide-induced immunosuppressed mouse model, the effect of Yangyuan powder on the carbon particle clearance ability of mice was observed, and its immune-enhancing effect was evaluated.

[0124] 2. Experimental Materials

[0125] Experimental animals: 70 SPF-grade Kunming mice (50 mice were actually enrolled, and 20 were reserved for backup), half male and half female, weighing 20-24g.

[0126] Test drug: Same as Experiment 1.

[0127] Positive control drug: Astragalus extract oral liquid (commercially available).

[0128] Modeling agent: Cyclophosphamide injection.

[0129] Reagents: Indian ink (diluted 4 times with physiological saline), sodium heparin, etc.

[0130] 3. Animal grouping and dosing regimen

[0131] Fifty mice were randomly divided into 5 groups of 10 each, with half males and half females:

[0132] 4. Experimental Methods

[0133] (1) Establishment of an immunosuppression model

[0134] Except for the normal control group, mice in the other groups were injected intraperitoneally with cyclophosphamide 80 mg / kg on days 1, 3 and 5 of the experiment to establish an immunosuppression model.

[0135] (2) Drug intervention

[0136] The day after the modeling was completed, each drug administration group was given the corresponding drug by gavage according to the above protocol, once a day for 10 consecutive days.

[0137] (3) Carbon particle clearance experiment

[0138] One hour after the last administration, mice in each group were injected via tail vein with a 4-fold diluted Indian ink solution at a concentration of 0.1 mL / 10 g body weight. At 2 minutes (T1) and 10 minutes (T2) after injection, 20 μL of blood was collected from the posterior orbital venous plexus and immediately added to 2 mL of 0.1% Na₂CO₃ solution, then mixed thoroughly. The absorbance (OD1 and OD2) was measured at 675 nm using 0.1% Na₂CO₃ solution as the zeroing point. Mice were sacrificed, and the liver and spleen were weighed. The clearance index K and phagocytic index α were calculated. K=(lgOD1-lgOD2) / (T2-T1); α = body weight / (liver weight + spleen weight) × K¹ / ³; 5. Experimental Results

[0139] Note: Compared with the normal control group, P<0.01; compared with the model control group, #P<0.05, ##P<0.01; data are expressed as Mean±SD.

[0140] 6. Experimental Conclusions

[0141] The clearance index K and phagocytic index α of the model control mice were significantly lower than those of the normal control group (P<0.01), indicating that the immunosuppression model was successfully established. After intervention with Yangyuan powder, the carbon particle clearance ability of mice in each dose group was improved to varying degrees, with the high-dose group (6.0 g / kg) showing a significant effect (P<0.01), and its effect was comparable to that of the positive control drug, Astragalus extract oral liquid. The results indicate that Yangyuan powder can significantly enhance the non-specific immune function of immunosuppressed mice.

[0142] (III) Clinical observation

[0143] Clinical observation of the efficacy of Yangyuan powder in patients with functional dyspepsia due to spleen and stomach deficiency.

[0144] 1. Clinical Data

[0145] (1) Source of cases

[0146] One hundred and twenty patients with functional dyspepsia who visited a traditional Chinese medicine clinic between March and December 2024 were selected and randomly divided into a treatment group and a control group, with 60 patients in each group. In the treatment group, there were 26 males and 34 females, aged 18–65 years, with a mean age of (42.5±10.8) years and a disease duration of 3 months–5 years, with a mean duration of (18.6±11.2) months. In the control group, there were 24 males and 36 females, aged 20–63 years, with a mean age of (41.8±11.3) years and a disease duration of 3 months–4.5 years, with a mean duration of (17.9±10.6) months. There were no statistically significant differences in gender, age, disease duration, or other general characteristics between the two groups (P>0.05), making them comparable.

[0147] (2) Diagnostic criteria

[0148] Western medicine diagnosis refers to the diagnostic criteria for functional dyspepsia in Rome IV: Functional Gastrointestinal Disorders; Traditional Chinese medicine diagnosis refers to the diagnostic criteria for spleen and stomach deficiency syndrome in the Consensus Opinion on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Functional Dyspepsia (2023). Main symptoms: ① fullness or dull pain in the stomach; ② loss of appetite; ③ abdominal distension or discomfort in the stomach after meals.

[0149] Secondary symptoms: ① fatigue and weakness; ② loose stools or difficulty in defecation; ③ lethargy and reluctance to speak; ④ sallow complexion.

[0150] Tongue and pulse: The tongue is pale or pale and swollen, with teeth marks on the sides, a thin white or white and greasy coating, and a thin and weak or deep and thready pulse.

[0151] A diagnosis can be made based on two primary symptoms and one secondary symptom, combined with tongue and pulse examination.

[0152] (3) Inclusion criteria

[0153] ① Meets the above-mentioned Western and Traditional Chinese Medicine diagnostic criteria; ② Age 18–65 years; ③ Has not taken other prokinetic drugs or spleen-strengthening Chinese medicines within 2 weeks prior to treatment; ④ Has obtained informed consent and signed an informed consent form.

[0154] (4) Exclusion criteria

[0155] ① Individuals who have been ruled out for organic diseases such as peptic ulcers and gastrointestinal tumors by gastroscopy; ② Individuals with serious primary diseases of the heart, liver, or kidneys; ③ Pregnant or lactating women; ④ Individuals allergic to any of the components of the drug being studied; ⑤ Individuals with mental illness or who are unable to cooperate.

[0156] 2. Treatment methods

[0157] Treatment group: The patients took 15g of the nourishing powder prepared in Example 1 of this invention, mixed with warm water, once before breakfast and once before dinner. One course of treatment lasted 4 weeks and a total of 1 course of treatment was observed.

[0158] Control group: Take Shenling Baizhu Granules (commercially available, 6g per bag), 1 bag (6g) each time, once before breakfast and once before dinner, for 4 weeks as one course of treatment, and observe for a total of 1 course of treatment.

[0159] During treatment, discontinue other medications that affect gastrointestinal function and instruct the patient to maintain a regular diet and sleep schedule.

[0160] 3. Efficacy observation indicators

[0161] (1) Clinical symptom scoring

[0162] The primary symptoms (abdominal fullness / dull pain, loss of appetite, postprandial abdominal distension) and secondary symptoms (fatigue, loose stools) are classified into four levels according to severity, with scores of 0, 2, 4, and 6 (primary symptoms) and 0, 1, 2, and 3 (secondary symptoms), respectively. The specific grading criteria are as follows:

[0163] (2) Overall efficacy evaluation criteria

[0164] Formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs": Clinical cure: clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%.

[0165] Significant effect: Clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%.

[0166] Effective: Clinical symptoms and signs improved, and the syndrome score decreased by ≥30%.

[0167] Ineffective: No significant improvement in clinical symptoms and signs, and a decrease in syndrome score of <30%.

[0168] Calculation formula (nimodipine method): Symptom score reduction rate (%) = [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%; Overall effective rate (%) = (clinically cured + significantly effective + effective) / total number of cases × 100%; (3) Serological marker detection Five mL of venous blood was collected in the morning before and after treatment on an empty stomach. Serum was separated and the levels of gastrin (GAS) and motilin (MTL) were measured (using ELISA method, kit purchased from XX Biotechnology Co., Ltd.).

[0169] 4. Safety Evaluation

[0170] Complete blood count, urinalysis, liver function (ALT, AST), kidney function (Cr, BUN), and electrocardiogram were performed before and after treatment, and adverse events during treatment were recorded.

[0171] 5. Statistical Methods

[0172] SPSS 26.0 software was used for statistical analysis. Quantitative data were expressed as Mean ± SD. Paired t-tests were used for within-group comparisons, and independent samples t-tests were used for between-group comparisons. Chi-square tests were used for categorical data. P < 0.05 was considered statistically significant.

[0173] 6. Experimental Results

[0174] (1) Comparison of clinical symptom scores before and after treatment in the two groups of patients

[0175] Before treatment, there was no statistically significant difference in the total scores between the two groups (P>0.05), indicating they were comparable. After treatment, the total scores of both groups decreased significantly compared to before treatment (P<0.01), and the decrease in the treatment group was greater than that in the control group (P<0.01).

[0176] (2) Comparison of overall efficacy between the two groups of patients

[0177] The total effective rate in the treatment group was 93.3%, while the total effective rate in the control group was 83.3%. The difference between the two groups was statistically significant (χ²=4.615, P<0.05).

[0178] (3) Comparison of serum GAS and MTL levels before and after treatment in the two groups of patients

[0179] Note: Compared with the pre-treatment level in this group, P<0.05. P<0.01; compared with the control group after treatment, △P<0.05.

[0180] Before treatment, there was no statistically significant difference in serum GAS and MTL levels between the two groups (P>0.05). After treatment, both groups showed significantly higher levels of GAS and MTL compared to before treatment (P<0.05 or P<0.01), with the increase in the treatment group being greater than that in the control group (P<0.05).

[0181] 7. Typical Cases

[0182] Case 1: Mr. Zhang, male, 42 years old, company employee. Chief complaint: Recurrent epigastric fullness and poor appetite for more than 2 years, worsening in the past month. Current symptoms: epigastric fullness, especially after meals, poor appetite (less than 200g of staple food per day), fatigue, loose stools (2-3 times a day), sallow complexion, pale and swollen tongue with teeth marks on the edges and a white and greasy coating, and a weak pulse. Western medicine diagnosis: functional dyspepsia; Traditional Chinese medicine diagnosis: spleen and stomach deficiency with dampness. Treatment with Nourishing Yuan Powder (Example 1 of this invention), 15g each time, twice a day, morning and evening, mixed with warm water. After 1 week of medication, appetite significantly improved and epigastric fullness lessened; after 2 weeks, stools became formed and fatigue improved; after 4 weeks of treatment, all symptoms basically disappeared, food intake returned to normal, weight stabilized, physical strength significantly recovered, and daily work endurance increased. The syndrome score decreased from 21 points before treatment to 2 points, with a total score reduction rate of 90.5%, and the therapeutic effect was rated as significant. No recurrence was observed during a one-month follow-up.

[0183] Case 2: Ms. Li, female, 35 years old, teacher. Chief complaint: Postprandial abdominal distension accompanied by decreased appetite for over one year. Current symptoms: Postprandial abdominal distension lasting 2-3 hours before relief, poor appetite (approximately 100g of staple food per meal), fatigue, lethargy, sticky and incomplete bowel movements, pale red tongue with a white, greasy coating, and a weak pulse. Traditional Chinese medicine diagnosis: Spleen and stomach deficiency with internal dampness and turbidity. Treatment with Yangyuan Powder (Example 1 of this invention), 15g each time, twice a day (morning and evening). After 2 weeks of treatment, abdominal distension lessened and appetite improved; after 4 weeks of treatment, postprandial abdominal distension essentially disappeared, appetite returned to normal, and bowel movements became regular. The syndrome score decreased from 16 points before treatment to 3 points, with a total score reduction rate of 81.3%, and the efficacy was rated as significant.

[0184] 8. Safety Results

[0185] No abnormalities were observed in blood routine tests, urine routine tests, liver function tests (ALT, AST), kidney function tests (Cr, BUN), and electrocardiograms in either group before or after treatment. One patient in the treatment group experienced mild abdominal discomfort initially, which resolved spontaneously after three days of continued medication and did not affect treatment. No serious adverse events occurred in either group. This indicates that Yangyuan powder has good safety and is suitable for long-term use.

[0186] 9. Clinical observation conclusions

[0187] The results of this study indicate that Yangyuan powder significantly improved the clinical symptoms of patients with functional dyspepsia due to spleen and stomach deficiency, with a total effective rate of 93.3%, which was superior to the 83.3% in the control group (P<0.05). Yangyuan powder significantly increased serum gastrin (GAS) and motilin (MTL) levels in patients, promoting gastrointestinal motility and digestive juice secretion, which may be one of its mechanisms of action in improving functional dyspepsia. No significant adverse reactions occurred during the treatment, demonstrating good safety.

[0188] VIII. Comprehensive Experimental Conclusions

[0189] Based on in vitro pepsin activity experiments, gastrointestinal motility function experiments in spleen-deficient mice, carbon clearance experiments in immunosuppressed mice, and clinical observations in patients with functional dyspepsia due to spleen and stomach weakness, the following comprehensive conclusions were drawn: Promoting digestive function: In vitro, Yangyuan powder can significantly enhance pepsin activity (with a promotion rate of up to 49.4%). In vivo, it can significantly increase gastric emptying rate (70.5% in the high-dose group) and intestinal propulsion rate (53.1% in the high-dose group) in mice with spleen deficiency. It can also increase serum gastrin and motilin levels in patients with functional dyspepsia, indicating that it has good digestive aid and gastrointestinal motility promoting effects.

[0190] Enhancing immune function: Yangyuan powder can significantly increase the carbon clearance index K and phagocytic index α in immunosuppressed mice and enhance the phagocytic function of monocytes and macrophages, indicating that it has an immune-enhancing effect.

[0191] Improving clinical symptoms: Yangyuan powder has a total clinical efficacy rate of 93.3% for patients with functional dyspepsia due to spleen and stomach deficiency. It can effectively improve symptoms related to spleen and stomach deficiency, such as epigastric fullness, loss of appetite, abdominal distension after meals, fatigue, and loose stools.

[0192] Good safety profile: No obvious toxic side effects were observed during the experiment, and all safety indicators were normal, indicating that Yangyuan powder is highly safe and suitable for long-term use.

[0193] In summary, the Yangyuan powder of this invention has the effects of invigorating qi, strengthening the spleen, and removing dampness. It can improve the function of the spleen and stomach through multiple pathways, such as regulating the secretion of gastrointestinal hormones, promoting gastrointestinal motility, and enhancing immune function. Moreover, it has good safety and broad prospects for promotion and application.

[0194] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A method for preparing a nourishing powder, characterized in that, Includes the following steps: (1) Weigh the following raw materials by weight percentage: Codonopsis pilosula 3%–5%, Poria cocos 10%–15%, lotus seeds (without heart) 10%–15%, Dioscorea opposita 10%–15%, Euryale ferox 10%–15%, Coix lacryma-jobi 25%–30%, japonica rice 10%–15%, fresh malt 15%–30%, and edible gypsum powder 2%–3%; (2) Process Codonopsis pilosula, Poria cocos, lotus seeds (without the core), Dioscorea opposita, Euryale ferox, and Coix lacryma-jobi into coarse powder for later use; (3) Cook the japonica rice into rice, and mix the fresh malt with edible gypsum powder to make a paste, thus obtaining malt paste; (4) Dilute the rice described in step (3) with water to make porridge, and control the temperature of the porridge to be 45℃~60℃; (5) Mix the malt paste from step (3) with the porridge from step (4) and let it soak at room temperature for 2 to 4 hours until the rice becomes a paste to obtain the first soaking mixture; (6) Add the coarse powder from step (2) to the first foaming compound from step (5) and soak for 2-3 hours until the broth is absorbed to obtain the second foaming compound; (7) Steam the second foamed compound from step (6) until it is cooked, dry it until the moisture content is qualified, and then pulverize it into fine powder to obtain Yangyuan powder.

2. The preparation method according to claim 1, characterized in that, The temperature control of the porridge in step (4) is as follows: 45℃~55℃ in spring and summer, and 55℃~60℃ in autumn and winter.

3. The preparation method according to claim 1, characterized in that, The soaking time in step (5) is controlled as follows: 2-3 hours in spring and autumn, and 3-4 hours in summer and winter.

4. The preparation method according to claim 1, characterized in that, The drying process described in step (7) is constant temperature drying.

5. The preparation method according to claim 1, characterized in that, The weight percentages of the raw materials are as follows: Codonopsis pilosula 4%, Poria cocos 12%, lotus seeds (without the core) 12%, Dioscorea opposita 12%, Euryale ferox 12%, Coix lacryma-jobi 28%, japonica rice 12%, fresh malt 20%, and edible gypsum powder 2%.

6. The Yangyuan powder prepared by the preparation method according to any one of claims 1 to 5.

7. The application of the nourishing powder according to claim 6 in the preparation of food or health products with the effects of invigorating qi, strengthening the spleen, and removing dampness.

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