A composition, food and use thereof for preventing and / or improving iron deficiency anemia

Abstract

The present application provides a kind of composition, food and its application to help prevent and / or improve iron deficiency anemia.The composition comprises beta-casein and Poria cocos extract, and the mass ratio of beta-casein and Poria cocos extract is (0.2-60):1.The composition can improve the symptoms of iron deficiency anemia, promote the generation of red blood cells, promote the recovery of hematopoietic function, increase the hemoglobin content, realize multiple regulation mechanisms, and effectively improve the state of iron deficiency anemia.

Description

Technical Field

[0001] This invention relates to the field of food or health food technology, specifically to a composition, food, and application that helps prevent and / or improve iron deficiency anemia. Background Technology

[0002] With social development and improved living standards, people are paying increasing attention to health and healthcare. Anemia is a common blood disorder characterized by a decrease in the number of red blood cells in peripheral blood, leading to insufficient oxygen supply to tissues and organs. The prevalence of anemia is as high as 24.8%, affecting the health of 1.62 billion people. Nutritional anemia refers to a condition caused by a relative or absolute deficiency of essential nutrients for blood production, such as iron, folic acid, and vitamin D, resulting in insufficient hemoglobin formation or red blood cell production and impaired hematopoietic function. For example, insufficient hemoglobin is one of the indicators of iron-deficiency anemia. Iron deficiency hinders hemoglobin synthesis, leading to insufficient oxygen-carrying molecules and a decreased oxygen-carrying capacity. Increasing hemoglobin levels can promote an increase in oxygen-carrying molecules, restore oxygen-carrying capacity, and thus improve the iron-deficiency anemia phenotype. Long-term dialysis and chemotherapy can also cause anemia.

[0003] Currently, treatments for anemia mainly include dietary adjustments, medication, and blood transfusions. However, these methods have some limitations. Especially for the elderly, long-term illness can lead to malnutrition, making it difficult to meet their additional nutritional needs through daily diet, easily resulting in anemia and malnutrition. Furthermore, cancer-related anemia (CRA) occurs in cancer patients during disease progression and treatment, with an incidence rate as high as 30%-90%, significantly impacting clinical treatment outcomes and survival.

[0004] CN114949177A discloses a pharmaceutical composition comprising therapeutically effective amounts of Poria cocos, Ziziphus jujuba seed, Nelumbo nucifera seed, γ-aminobutyric acid, theanine, and casein peptide. This composition can effectively alleviate symptoms such as fatigue, chest tightness, nausea, and heaviness in the head and body caused by damp-heat invading the heart meridian, thus playing a role in early intervention. However, this literature still has issues regarding further optimization of the formulation and dosage of the pharmaceutical composition.

[0005] CN114010762A discloses a preparation for improving anemia symptoms, comprising the following components by weight: 3-10 parts of hemoglobin polypeptide powder, 3-10 parts of collagen peptide powder, 3-10 parts of jujube extract, 0.1-0.3 parts of taurine, 0.01-0.04 parts of sucralose, 0.015-0.025 parts of steviol glycosides, 0.1-0.3 parts of erythritol, 0.6-0.8 parts of citric acid, 0.05-0.15 parts of pectin, 0.15-0.18 parts of food flavoring, 0.1-0.2 parts of ginseng powder, and 0.1-0.2 parts of donkey-hide gelatin peptide powder. This preparation has high absorption rate, does not accumulate, has high safety with no gastrointestinal irritation, and effectively improves anemia indicators, especially tumor-related anemia. However, there is still a need to further optimize the preparation method of the hemoglobin polypeptide powder to improve the content and bioavailability of heme iron.

[0006] Current methods for treating anemia have limitations and cannot meet the needs of the elderly and cancer patients. Existing traditional Chinese medicine compositions often target a single point to improve anemia, lacking the ability to work synergistically with multiple targets, making it difficult to fundamentally improve anemia symptoms. The content and bioavailability of active ingredients in existing compositions need to be improved, making it difficult to achieve precise treatment effects. The compatibility and dosage of existing compositions have not been optimized, making it difficult to achieve the best treatment results. Personalized treatment plans for different patients' individual differences and disease progression have not been fully considered, making it difficult to achieve precise treatment.

[0007] Therefore, developing a safe, effective, and simple composition for improving iron deficiency anemia is of great significance. Traditional Chinese medicine compositions have unique advantages in improving iron deficiency anemia, but currently, no composition has been reported to improve iron deficiency anemia symptoms from multiple targets, particularly in increasing hemoglobin levels and improving the staining intensity of cardiac erythrocytes. Therefore, exploring novel traditional Chinese medicine compositions that improve anemia symptoms through multi-target mechanisms of action has become a current research hotspot and challenge. Summary of the Invention

[0008] One object of the present invention is to provide the use of a composition in the preparation of a product which helps to prevent and / or improve iron deficiency anemia.

[0009] Another object of the present invention is to provide a composition that helps prevent and / or improve iron deficiency anemia.

[0010] Another object of the present invention is to provide a food that helps prevent and / or improve iron deficiency anemia.

[0011] Another object of the present invention is to provide a method for preparing a modified milk powder that helps prevent and / or improve iron deficiency anemia.

[0012] Specifically, on the one hand, the present invention provides the use of a composition in the preparation of a product that helps prevent and / or improve iron deficiency anemia, the composition comprising β-casein and Poria cocos extract;

[0013] The mass ratio of β-casein to Poria cocos extract is (0.2-60):1.

[0014] According to a specific embodiment of the present invention, the Poria cocos extract used is a powdered solid, and its preparation process is as follows: Poria cocos slices are boiled with 5 times their weight of water for 1.5 hours for extraction; the extract is filtered, and the filtrate is concentrated to a specific gravity of 1.1; the concentrated liquid is centrifuged, and solid corn syrup (the amount of solid corn syrup accounts for 50% of the total solid content) is added to the centrifuged liquid and mixed evenly, then spray-dried. The inlet air temperature of the spray dryer is 200℃, and the outlet air temperature is 100℃; the dried paste obtained from spray drying is pulverized and passed through an 80-mesh sieve to obtain the Poria cocos extract, which is a grayish-white powder with a yield of 20%. Testing showed that the total triterpenoid content was ≥0.06%, and the content of Poria cocos β-(1... 3)-Glucan in the form of anhydrous glucose (C6H) 12 O6) is calculated as ≥25.0%.

[0015] According to a specific embodiment of the present invention, the β-casein is a milk-derived component, which has the characteristics of high absorption rate, non-accumulation, and high safety.

[0016] According to a specific embodiment of the present invention, the mass ratio of β-casein to Poria cocos extract is (1-34.7):1.

[0017] According to a specific embodiment of the present invention, the mass ratio of β-casein to Poria cocos extract is (1-24):1.

[0018] According to a specific embodiment of the present invention, the composition comprises β-casein and Poria cocos extract.

[0019] According to a specific embodiment of the present invention, the product that helps prevent and / or improve iron deficiency anemia is a nutritional supplement, health food, or food for special medical purposes.

[0020] According to a specific embodiment of the present invention, the aid in preventing and / or improving iron deficiency anemia includes promoting the production of red blood cells.

[0021] According to a specific embodiment of the present invention, the aid in preventing and / or improving iron deficiency anemia includes promoting the recovery of hematopoietic function.

[0022] According to a specific embodiment of the present invention, the aid in preventing and / or improving iron deficiency anemia includes increasing hemoglobin levels.

[0023] On the other hand, the present invention also provides a composition that helps prevent and / or improve iron deficiency anemia, the composition comprising β-casein and Poria cocos extract in a mass ratio of (0.2-60):1.

[0024] On the other hand, the present invention also provides a food that helps prevent and / or improve iron deficiency anemia, wherein the food contains the above-described composition.

[0025] According to a specific embodiment of the present invention, the food is a nutritional product, a health food, or a food for special medical purposes.

[0026] According to a specific embodiment of the present invention, when the food is solid, the content of Poria cocos extract in the food is 30-1000 mg / 100g, and the content of β-casein is 30-24000 mg / 100g; when the food is liquid, the content of Poria cocos extract is 39-1300 μg / mL, and the content of β-casein is 39-31200 μg / mL.

[0027] According to a specific embodiment of the present invention, when the food is solid, the content of Poria cocos extract in the food is 30-1000 mg / 100g, and the content of β-casein is 30-1000 mg / 100g; when the food is liquid, the content of Poria cocos extract is 39-1300 μg / mL, and the content of β-casein is 39-1300 μg / mL.

[0028] According to a specific embodiment of the present invention, the food is adult formulated milk powder.

[0029] According to a specific embodiment of the present invention, the content of Poria cocos extract in the modified milk powder is 30-1000 mg / 100g, and the content of β-casein in the modified milk powder is 30-24000 mg / 100g; converted to milk volume, the content of Poria cocos extract is 39-1300 μg / mL, and the content of β-casein is 39-31200 μg / mL.

[0030] According to a specific embodiment of the present invention, the content of Poria cocos extract in the modified milk powder is 30-1000 mg / 100g, and the content of β-casein in the modified milk powder is 30-1000 mg / 100g; converted to milk volume, the content of Poria cocos extract is 39-1300 μg / mL, and the content of β-casein is 39-1300 μg / mL.

[0031] According to a specific embodiment of the present invention, preferably, the β-casein of the modified milk powder can be derived from one or more of the following: raw cow's milk, whole milk powder, skim milk powder, whey protein powder, demineralized whey powder, α-lactalbumin powder, β-casein powder, raw sheep's milk and raw sheep's milk processed products, or it can be derived from exogenously added β-casein raw materials.

[0032] According to a specific embodiment of the present invention, preferably, the Poria cocos extract may be different bioactive substances such as Poria cocos polysaccharide, triterpenoids, and β-poria polysaccharide.

[0033] According to a specific embodiment of the present invention, preferably, the protein source of the modified milk powder includes one or more of the following: raw cow's milk, whey protein powder, demineralized whey powder, α-lactalbumin powder, β-casein powder, skim milk powder, or raw sheep's milk and raw sheep's milk processed products.

[0034] According to a specific embodiment of the present invention, preferably, the protein sources of the modified milk powder include: 0-8000 parts by weight of raw milk, 0-900 parts by weight of whole milk powder, 0-500 parts by weight of skim milk powder, 0-300 parts by weight of whey protein powder, 0-450 parts by weight of demineralized whey powder, 0-50 parts by weight of α-lactalbumin powder, and 0-50 parts by weight of β-casein powder.

[0035] The fat source of the formulated milk powder includes one or more of the following: milk fat, phospholipids, and vegetable oils. The vegetable oils include any one or more of the following: sunflower oil, corn oil, soybean oil, low-erucic acid rapeseed oil, coconut oil, palm oil, perilla oil, or walnut oil.

[0036] The carbohydrates in the modified milk powder come from a portion of basic raw materials containing lactose, such as milk, whole milk powder, and / or skim milk powder, and the remainder comes from additional lactose raw materials, as well as sugars such as white sugar, or solid corn syrup or maltodextrin.

[0037] According to a specific embodiment of the present invention, preferably, the carbohydrate source of the modified milk powder includes: 0-200 parts by weight of white sugar, 0-300 parts by weight of solid corn syrup, and 0-300 parts by weight of maltodextrin.

[0038] According to a specific embodiment of the present invention, preferably, the modified milk powder further contains excipients.

[0039] According to a specific embodiment of the present invention, preferably, the modified milk powder further contains 1-200 parts by weight of galactooligosaccharide syrup; 1-200 parts by weight of resistant dextrin; 1-50 parts by weight of isomerized lactose solution or 1-200 parts by weight of other dietary fiber.

[0040] According to a specific embodiment of the present invention, preferably, the modified milk powder further contains 0.5-3 parts by weight of vitamin packet, 0.5-5 parts by weight of mineral packet, 0.1-16 parts by weight of calcium carbonate, and 0-50 parts by weight of milk mineral salt.

[0041] According to a specific embodiment of the present invention, preferably, the modified milk powder further contains 0-6 parts by weight of phospholipids.

[0042] According to a specific embodiment of the present invention, preferably, the modified milk powder further contains 0.1-1 parts by weight of lactoferrin.

[0043] According to a specific embodiment of the present invention, preferably, the modified milk powder further contains probiotics, such as HN019 1×10 6 CFU / g-1×10 11 CFU / g; Bb-12 1×10 6 CFU / g-1×10 11 CFU / g, etc.

[0044] According to a specific embodiment of the present invention, preferably, the raw materials of the modified milk powder include: raw milk, lactose, WPC80 whey protein concentrate, demineralized whey powder, vegetable oil, lactose, solid corn syrup, milk mineral salts, anhydrous butter, phospholipids, and nutrient packets (complex vitamins and minerals (iron, zinc, calcium)).

[0045] According to a specific embodiment of the present invention, preferably, the modified milk powder can be a women's milk powder, the raw materials of which include: raw milk, lactose, WPC80 whey protein concentrate, demineralized whey powder, vegetable oil, lactose, solid corn syrup, milk mineral salts, anhydrous butter, phospholipids, and nutrient packets (complex vitamins and minerals (iron, zinc, calcium)).

[0046] On the other hand, the present invention also provides a method for preparing the above-mentioned modified milk powder, the main process of which includes: ingredient mixing, homogenization, concentration and sterilization, spray drying, and dry mixing to obtain the finished product.

[0047] Poria cocos extract is added during the dry mixing process;

[0048] β-casein is added during the ingredient preparation process.

[0049] Specific preparation methods include:

[0050] Mix raw milk that has been coarsely filtered, homogenized and sterilized, powdered raw materials and melted oil raw materials, add galactooligosaccharide syrup to a small hopper, add nutrient packets to a nutrient tank to obtain a mixed liquid;

[0051] The mixed liquid is filtered, homogenized, cooled, concentrated and sterilized, spray dried, and then dried and cooled in a fluidized bed to obtain dried milk powder, which is then mixed with Poria cocos powder and sieved to obtain the modified milk powder.

[0052] In the above preparation method, the preferred primary pressure for homogenization of the mixed liquid is 105±5 bar, and the preferred secondary pressure is 32±3 bar.

[0053] In the above preparation method, it is preferred that the concentration and sterilization adopts double-effect concentration, more preferably, the sterilization temperature is ≥83℃ and the sterilization time is 25 seconds; even more preferably, the output concentration is 48%-52% dry matter.

[0054] In the above preparation method, the preferred inlet air temperature of the spray dryer is 165-190℃, the exhaust air temperature is 75-95℃, the high-pressure pump pressure is 160-210 bar, and the tower negative pressure is -4 mbar to -2 mbar.

[0055] In the above preparation method, the fluidized bed drying and cooling preferably includes two drying and cooling cycles, with the temperature of the milk powder after the second drying and cooling cycle being 25-30℃; at the same time, the phospholipids are mixed with the carrier and heated to 60-65℃, and then uniformly dispersed onto the surface of the milk powder under the action of compressed air.

[0056] In one specific embodiment of the present invention, the preparation process of the modified milk powder of the present invention may include the following specific steps:

[0057] 1) Milk coarse filtration: After raw milk is coarsely filtered and degassed in a balance cylinder, it is preheated by a plate heat exchanger and then separated by a separator to obtain milk with impurities removed.

[0058] 2) Milk homogenization and sterilization: After removing impurities, part of the milk is homogenized in a homogenizer, while the other part is not homogenized. The homogenized milk and the unhomogenized milk are mixed and then enter the sterilization system for sterilization. After sterilization, the milk enters the mixing tank.

[0059] 3) Powder addition: Powder raw materials are metered according to the formula and then added to the powder mixing tank through the pneumatic conveying system for storage.

[0060] 4) Vacuum powder suction: Various powder raw materials in the powder mixing tank are sucked into the mixing tank through a vacuum system.

[0061] 5) Adding compound nutrient fortifiers: Add the nutrient packets (except vitamin C) separately, dissolve them in 100-200kg of purified water, and then pour them into the mixing tank. After each type is added, rinse the addition tank and pipeline with 100kg of purified water.

[0062] 6) Adding small ingredients: Add galactooligosaccharide syrup and milk mineral salt to the small hopper and then transfer them to the mixing tank.

[0063] 7) Filtration: Mix the raw materials in a mixing tank, and then filter the resulting liquid through a filter screen to remove any physical impurities that may have been introduced from the raw materials.

[0064] 11) Homogenization: The mixed liquid is homogenized by a homogenizer. The first pressure is 105±5 bar and the second pressure is 32±3 bar. The fat globules are mechanically processed and dispersed into uniform fat globules.

[0065] 12) Cooling and storage: The homogenized liquid enters the plate heat exchanger for cooling. It is cooled to below 20°C and temporarily stored in the pre-storage tank. It will enter the next process within 6 hours. The agitator is turned on according to the set requirements.

[0066] 13) Concentration and sterilization: Double-effect concentration is used during production, with a sterilization temperature of ≥83℃ and a sterilization time of 25 seconds; the output concentration is 48%-52% dry matter.

[0067] 14) Concentrated milk storage, preheating and filtration, spray drying: The concentrated milk is temporarily stored in a concentrated milk balance tank; it is preheated to 60-70℃ by a scraper preheater, and after preheating, the material is filtered through a 1mm pore size filter and then spray-dried in a drying tower by a high-pressure pump. Fine powder is agglomerated at the top of the tower or in a fluidized bed as required; the inlet air temperature is 165-190℃, the outlet air temperature is 75-95℃, the high-pressure pump pressure is 160-210 bar, and the tower negative pressure is -4 mbar to -2 mbar.

[0068] 15) Fluidized bed drying and cooling: The milk powder coming out of the drying tower is dried again in a fluidized bed (first stage) and then cooled to 25-30℃ in a fluidized bed (second stage); at the same time, phospholipids are mixed with the carrier and heated to 60-65℃. Under the action of compressed air, the phospholipids are evenly dispersed on the surface of the milk powder, causing the powder particles to agglomerate, increasing their particle size and solubility, and thus obtaining milk powder.

[0069] 16) Packaging: Weigh and seal the Poria cocos powder and other plant extracts and vitamin C according to the formula requirements.

[0070] 17) Dry mixing: Mix the weighed Poria cocos powder, other plant extracts, vitamin C and milk powder in a dry mixer.

[0071] 18) Sieving: The milk powder is sieved to make the particle size uniform and the powder residue is disposed of as waste.

[0072] 19) Powder discharge: Collect powder in a sterilized powder collection box and transport it from the powder discharge room to the powder loading room.

[0073] 20) Powdering: Pour the milk powder into the powder storage tank on the large and small packaging machines according to the packaging requirements.

[0074] 21) Packaging: Nitrogen-filled packaging using automatic packaging machines of different specifications; oxygen content is below 1-5% during nitrogen filling.

[0075] 22) Packing: Put the packaged small bags into the carton and add the powder scoop at the same time, and seal the carton with a sealing machine.

[0076] 23) Finished product inspection: Sampling inspection of packaged products according to the inspection plan.

[0077] 24) Warehousing and storage: Products that have passed inspection shall be stored in warehouses at room temperature with a humidity of ≤65% to obtain modified milk powder products.

[0078] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0079] Existing technologies lack multi-target synergistic effects in treating iron deficiency anemia. Therefore, to address this issue, the present invention provides a composition for improving the efficacy of iron deficiency anemia, comprising β-casein and Poria cocos, which improves iron deficiency anemia symptoms through synergistic effects. The β-casein + Poria cocos extract composition of the present invention can improve iron deficiency anemia symptoms by increasing the staining intensity of cardiac erythrocytes and hemoglobin content, achieving multiple regulatory mechanisms to effectively improve the state of iron deficiency anemia (including iron deficiency anemia caused by insufficient hemoglobin and weak oxygen-carrying capacity due to iron deficiency). The present invention achieves a carefully formulated composition by optimizing the ratio and dosage of β-casein and Poria cocos extract, improving the therapeutic effect and solving the problem of unoptimized drug composition formulation and dosage in existing technologies. This invention uses a zebrafish experimental model and accurately evaluates the efficacy of the sample in improving iron deficiency anemia through two indicators: cardiac erythrocyte staining intensity and hemoglobin content. This overcomes the shortcomings of existing technologies that lack personalized evaluation methods. The composition of this invention has a synergistic effect, which can significantly increase hemoglobin content and cardiac erythrocyte staining intensity, promote erythropoiesis, enhance cardiac erythrocyte staining intensity, enhance hemoglobin synthesis, and increase hemoglobin content. It is far more effective than a single component in improving the symptoms of iron deficiency anemia. Attached Figure Description

[0080] Figure 1 This is a typical image showing the staining intensity of red blood cells in the heart of zebrafish after sample processing. Detailed Implementation

[0081] In order to provide a clearer understanding of the technical features, objectives and beneficial effects of the present invention, the technical solution of the present invention will now be described in detail below, but it should not be construed as limiting the scope of implementation of the present invention.

[0082] It should be noted that, unless otherwise specified, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0083] Unless otherwise specified, all raw materials, reagents, instruments and equipment used in this invention can be purchased from the market or prepared by existing methods.

[0084] It should be understood that the terms “comprising,” “including,” and / or “containing” as used herein specify the presence of the stated features, integers, steps, components, or combinations thereof, but do not exclude the presence or addition of one or more other features, integers, steps, components, or combinations thereof.

[0085] It should be understood that the term "improved (iron deficiency) anemia" as used herein is defined as a reduction in the severity of anemia or an increase in hemoglobin levels in an individual compared to a control group that did not use the compositions of the present invention and / or compared to the individual's own condition before using the compositions of the present invention. Such a general profile is characterized, including or limited to the individual's anemia characteristics and / or the individual's cardiac erythrocyte staining intensity and / or the individual's hemoglobin levels.

[0086] It should be understood that the term “prevention” as used in this article means the suppression, mitigation, delay or prevention of the development or occurrence of symptoms of (iron deficiency) anemia in subjects, or the suppression, mitigation, delay or prevention of the recurrence of one or more symptoms of (iron deficiency) anemia.

[0087] It should be understood that the term "reduction" as used herein is defined as a decrease in the level of the corresponding (iron deficiency) anemia-related test indicators (including cardiac erythrocyte staining intensity and hemoglobin) in an individual relative to a control group that did not use the composition of the present invention and / or relative to the individual before using the composition of the present invention. The term "improvement" as used herein is defined as an increase in the level of the corresponding test indicators (including cardiac erythrocyte staining intensity and hemoglobin) in an individual relative to a control group that did not use the composition of the present invention and / or relative to the individual before using the composition of the present invention.

[0088] The endpoints and any values ​​of the ranges disclosed in this invention are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed in this invention.

[0089] The present invention provides the following preparation examples:

[0090] Preparation Example 1:

[0091] This preparation example provides a modified milk powder, which is a formula milk powder composed of β-casein, Poria cocos powder, and other raw materials added in appropriate proportions, along with folic acid and iron from the basic formula. The mass ratio of β-casein to Poria cocos powder is 2:1.

[0092] The specific formula is shown in Table 1:

[0093] Table 1

[0094]

[0095] The specific preparation steps in this preparation example include:

[0096] 1) Milk coarse filtration: After raw milk is coarsely filtered and degassed in a balance cylinder, it is preheated by a plate heat exchanger and then separated by a separator to obtain milk with impurities removed.

[0097] 2) Milk homogenization and sterilization: After removing impurities, part of the milk is homogenized in a homogenizer, while the other part is not homogenized. The homogenized milk and the unhomogenized milk are mixed and then enter the sterilization system for sterilization. After sterilization, the milk enters the mixing tank.

[0098] 3) Powder addition: Powder raw materials (skim milk powder, solid corn syrup, lactose) are metered according to the formula and then added to the powder mixing tank through the pneumatic conveying system for storage.

[0099] 4) Vacuum powder suction: Various powder raw materials in the powder mixing tank are sucked into the mixing tank through a vacuum system.

[0100] 5) Adding compound nutrient fortifiers: Add the nutrient packets (except vitamin C) separately, dissolve them in 100-200kg of purified water, and then pour them into the mixing tank. After each type is added, rinse the addition tank and pipeline with 100kg of purified water.

[0101] 6) Adding small ingredients: Add milk mineral salt to the small hopper and then extract it into the mixing tank.

[0102] 7) Filtration: Mix the raw materials in a mixing tank, and then filter the resulting liquid through a filter screen to remove any physical impurities that may have been introduced from the raw materials.

[0103] 11) Homogenization: The mixed liquid is homogenized by a homogenizer. The first pressure is 105±5 bar and the second pressure is 32±3 bar. The fat globules are mechanically processed and dispersed into uniform fat globules.

[0104] 12) Cooling and storage: The homogenized liquid enters the plate heat exchanger for cooling. It is cooled to below 20°C and temporarily stored in the pre-storage tank. It will enter the next process within 6 hours. The agitator is turned on according to the set requirements.

[0105] 13) Concentration and sterilization: Double-effect concentration is used during production, with a sterilization temperature of ≥83℃ and a sterilization time of 25 seconds; the output concentration is 48%-52% dry matter.

[0106] 14) Concentrated milk storage, preheating and filtration, spray drying: The concentrated milk is temporarily stored in a concentrated milk balance tank; it is preheated to 60-70℃ by a scraper preheater, and after preheating, the material is filtered through a 1mm pore size filter and then spray-dried in a drying tower by a high-pressure pump. Fine powder is agglomerated at the top of the tower or in a fluidized bed as required; the inlet air temperature is 165-190℃, the outlet air temperature is 75-95℃, the high-pressure pump pressure is 160-210 bar, and the tower negative pressure is -4 mbar to -2 mbar.

[0107] 15) Fluidized bed drying and cooling: The milk powder coming out of the drying tower is dried again in a fluidized bed (first stage) and then cooled to 25-30℃ in a fluidized bed (second stage); at the same time, phospholipids are mixed with the carrier and heated to 60-65℃. Under the action of compressed air, the phospholipids are evenly dispersed on the surface of the milk powder, causing the powder particles to agglomerate, increasing their particle size and solubility, and thus obtaining milk powder.

[0108] 16) Packaging: Weigh and seal the red ginseng powder, longan powder, wolfberry powder, poria powder, and vitamin C according to the formula requirements.

[0109] 17) Dry mixing: Mix the weighed Poria cocos powder, red ginseng powder, longan powder, wolfberry powder, vitamin C and milk powder in a dry mixer.

[0110] 18) Sieving: The milk powder is sieved to make the particle size uniform and the powder residue is disposed of as waste.

[0111] 19) Powder discharge: Collect powder in a sterilized powder collection box and transport it from the powder discharge room to the powder loading room.

[0112] 20) Powdering: Pour the milk powder into the powder storage tank on the large and small packaging machines according to the packaging requirements.

[0113] 21) Packaging: Nitrogen-filled packaging using automatic packaging machines of different specifications; oxygen content is below 1-5% during nitrogen filling.

[0114] 22) Packing: Put the packaged small bags into the carton and add the powder scoop at the same time, and seal the carton with a sealing machine.

[0115] 23) Finished product inspection: Sampling inspection of packaged products according to the inspection plan.

[0116] 24) Warehousing and storage: Products that have passed inspection shall be stored in warehouses at room temperature with a humidity of ≤65% to obtain modified milk powder products.

[0117] Preparation Example 2:

[0118] This preparation example provides a modified milk powder, which is a formula milk powder composed of β-casein, Poria cocos powder, and other raw materials added in appropriate proportions, along with folic acid and iron from the basic formula. The mass ratio of β-casein to Poria cocos powder is 1:1. The total protein content of milk is 3.0%, the total protein content of skim milk powder is 30%, casein accounts for 80% of the total protein, and β-casein accounts for 3% of the casein.

[0119] The specific formula is shown in Table 2:

[0120] Table 2

[0121]

[0122] The specific preparation steps are the same as those in Preparation Example 1.

[0123] Preparation Example 3:

[0124] This preparation example provides a modified milk powder in which the mass ratio of β-casein to Poria cocos powder is 24:1. The specific formula is shown in Table 3.

[0125] Table 3

[0126]

[0127] The specific preparation steps are the same as those in Preparation Example 1.

[0128] Preparation Example 4:

[0129] This preparation example provides a modified milk powder in which the mass ratio of β-casein to Poria cocos powder is 34.7:1. The specific formula is shown in Table 4.

[0130] Table 4

[0131]

[0132] The specific preparation steps are the same as those in Preparation Example 1, except that no raw milk is added.

[0133] Preparation Example 5:

[0134] This preparation example provides a modified milk powder in which the mass ratio of β-casein to Poria cocos powder is 50:1. The specific formulation is shown in Table 5.

[0135] Table 5

[0136]

[0137] The specific preparation steps are the same as those in Preparation Example 1, except that no raw milk is added.

[0138] Preparation Example 6:

[0139] This preparation example provides a modified milk powder in which the mass ratio of β-casein to Poria cocos powder is 0.2:1. The specific formula is shown in Table 6.

[0140] Table 6

[0141]

[0142] The specific preparation steps are the same as those in Preparation Example 1.

[0143] The above-mentioned Poria cocos powder is a powdered extract of Poria cocos. The Poria cocos extract used is a powdered solid, and its preparation process is as follows: Poria cocos slices are boiled with 5 times their weight of water for 1.5 hours for extraction. The extract is filtered, and the filtrate is concentrated to a specific gravity of 1.1. The concentrated liquid is centrifuged, and solid corn syrup (the amount of solid corn syrup accounts for 50% of the total solid content) is added to the centrifuged liquid and mixed evenly. Then, it is spray-dried. The inlet air temperature of the spray dryer is 200℃, and the outlet air temperature is 100℃. The dried paste obtained from spray drying is pulverized and passed through 80 mesh to obtain the Poria cocos extract, which is a grayish-white powder with a yield of 20%. Testing showed that the total triterpenoid content was ≥0.06%, and the content of Poria cocos β-(1) was ≥0.06%. 3)-Glucan in the form of anhydrous glucose (C6H) 12 O6) is calculated as ≥25.0%.

[0144] The aforementioned red ginseng powder is a powdered red ginseng extract. The red ginseng extract is an extract obtained by water extraction process using red ginseng as raw material. The water extraction process includes water extraction, filtration, and concentration of the filtrate.

[0145] The aforementioned longan powder is a powdered longan extract. The longan extract is an extract obtained from longan as raw material through a water extraction process, which includes water extraction, filtration, and concentration of the filtrate.

[0146] The above-mentioned wolfberry powder is a powdered wolfberry extract. The wolfberry extract is an extract obtained by water extraction process using wolfberry as raw material. The water extraction process includes water extraction, filtration, and concentration of filtrate.

[0147] The following examples and comparative examples provide compositions in different proportions for animal experimental assays.

[0148] Example 1:

[0149] This embodiment provides a composition for improving iron deficiency anemia, comprising the following components in parts by weight:

[0150] β-casein 500 μg / mL, Poria cocos powder (powdered Poria cocos extract) 250 μg / mL;

[0151] The mass ratio of β-casein to Poria cocos powder is 2:1.

[0152] Example 2:

[0153] This embodiment provides a composition for improving iron deficiency anemia, comprising the following components in parts by weight:

[0154] β-casein 500 μg / mL, Poria cocos powder 500 μg / mL;

[0155] The mass ratio of β-casein to Poria cocos powder is 1:1.

[0156] Example 3:

[0157] This embodiment provides a composition for improving iron deficiency anemia, comprising the following components in parts by weight:

[0158] β-casein 960 μg / mL, Poria cocos powder 40 μg / mL;

[0159] The mass ratio of β-casein to Poria cocos powder is 24:1.

[0160] Example 4:

[0161] This embodiment provides a composition for improving iron deficiency anemia, comprising the following components in parts by weight:

[0162] β-casein 972 μg / mL; Poria cocos powder 28 μg / mL;

[0163] The mass ratio of β-casein to Poria cocos powder is 34.7:1.

[0164] Example 5:

[0165] This embodiment provides a composition for improving iron deficiency anemia, comprising the following components in parts by weight:

[0166] β-casein 983.6 μg / mL, Poria cocos powder 16.4 μg / mL;

[0167] The mass ratio of β-casein to Poria cocos powder is 60:1.

[0168] Example 6:

[0169] This embodiment provides a composition for improving iron deficiency anemia, comprising the following components in parts by weight:

[0170] β-casein 167 μg / mL, Poria cocos powder 833 μg / mL;

[0171] The mass ratio of β-casein to Poria cocos powder is 0.2:1.

[0172] Comparative Example 1:

[0173] This comparative example provides a substance comprising the following components in parts by weight:

[0174] β-casein 500 μg / mL.

[0175] Comparative Example 2:

[0176] This comparative example provides a substance comprising the following components in parts by weight:

[0177] β-casein 1000 μg / mL.

[0178] Comparative Example 3:

[0179] This comparative example provides a substance comprising the following components in parts by weight:

[0180] Poria cocos powder 250μg / mL.

[0181] Comparative Example 4:

[0182] This comparative example provides a substance comprising the following components in parts by weight:

[0183] Poria cocos powder 1000μg / mL.

[0184] The concentrations in the above examples and comparative examples refer to the concentrations in the zebrafish culture water.

[0185] In the examples, the β-casein used was commercially available β-casein with a purity of 98%.

[0186] I. Animal Experiments

[0187] 1. Laboratory animals

[0188] Zebrafish model organisms are used. Zebrafish have become one of the most valued model organisms in vertebrate developmental biology. Zebrafish genes share 87% similarity with human genes, and experimental results obtained on zebrafish for drugs or functional materials are often applicable to humans. The use of zebrafish as a model organism for verifying and evaluating the physiological functions of drugs or functional materials is increasingly popular in this field.

[0189] Vertebrate hematopoiesis is an evolutionarily conserved and highly regulated process involving the generation of differentiated blood cell lineages from hematopoietic stem cells. Zebrafish are a powerful genetic and developmental model for studying the development of the vertebrate circulatory system, particularly hematopoietic function, which is highly conserved in zebrafish compared to mammals. The formation of the zebrafish hematopoietic system, primarily comprising erythroid, myeloid, lymphoid, and megakaryocytic lineages, exhibits high homology in its related transcription factors and signal transduction pathways with humans. These characteristics make zebrafish more widely applicable in the study of human hematopoietic systems and blood diseases. In this invention, a zebrafish model is used to determine the staining intensity of erythrocytes and hemoglobin content in the zebrafish heart to confirm whether the test sample has the effect of improving (iron deficiency) anemia.

[0190] Iron deficiency can lead to impaired hemoglobin synthesis, so insufficient hemoglobin is one of the indicators of iron deficiency anemia. Insufficient hemoglobin leads to a lack of oxygen-carrying molecules, resulting in a decrease in oxygen-carrying capacity. Increasing hemoglobin levels can promote an increase in the content of oxygen-carrying molecules, restore oxygen-carrying capacity, and thus improve the phenotype of iron deficiency anemia.

[0191] Zebrafish were raised in aquarium water at 28℃ (water quality: 200 mg of readily soluble sea salt added per 1L of reverse osmosis water, conductivity 450~550 μS / cm; pH 6.5~8.5; hardness 50~100 mg / L CaCO3), laboratory animal use license number: SYXK (Zhejiang) 2022-0004, husbandry and management met the requirements of international AAALAC certification (certification number: 001458), IACUC ethics review number: IACUC-2025-12647-01.

[0192] 2. Experimental Materials: Poria cocos powder (powdered Poria cocos extract), β-casein, and standard dilution water were used as solvents. The Poria cocos extract was obtained by boiling Poria cocos slices in 8 times its volume of water for 1.5 hours, filtering the extract, and then boiling the residue in 6 times its volume of water for 1 hour, filtering the extract, and combining the filtrates. The filtrate was concentrated to a specific gravity of 1.1; the concentrated solution was centrifuged, and the centrifuged liquid was collected; the centrifuged liquid was mixed with 50% of the finished product amount of solid corn syrup and then dried in a spray dryer at an inlet temperature of 200℃ and an outlet temperature of 100℃; the resulting dry extract was pulverized and passed through an 80-mesh sieve to obtain the Poria cocos extract, which was a grayish-white powder containing 0.16% total triterpenes. Referring to the 2025 edition of the Pharmacopoeia of the People's Republic of China, the extract contained Poria cocos β-(1... 3)-Glucan in the form of anhydrous glucose (C6H) 12 O6) was calculated to be 60.0%.

[0193] Positive control: Shengxuening tablets (Rui Ke), batch number 20240710, Wuhan United Pharmaceutical Co., Ltd., solvent was ultrapure water.

[0194] 3. Intensity of cardiac erythrocyte staining

[0195] Wild-type AB strain zebrafish with a dpf of 4 were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). The water quality for fish farming was as follows: 200 mg of readily soluble sea salt was added to every 1 L of reverse osmosis water; conductivity was 450-550 µS / cm; pH was 6.5-8.5; and hardness was 50-100 mg / L CaCO3. Water-soluble samples were administered (water-soluble samples of the compositions given in the experimental groups were added to the fish farming water; the treatment concentrations of the compositions in the fish farming water for each formulation in the experimental groups were as described in Examples 1-4). The positive control, Shengxuening tablets, was treated at a concentration of 250 μg / mL in the fish farming water. A normal control group and a model control group were also set up, 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 phenylhydrazine to establish a zebrafish anemia model. After treatment at 28℃ for 8 hours, o-anisidine staining was performed. Following staining, 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 to analyze the staining intensity of zebrafish cardiac erythrocytes. The statistical analysis results of this index were used to evaluate the efficacy of the samples in improving iron deficiency anemia. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0196] 4. Hemoglobin content

[0197] Wild-type AB strain zebrafish with a dpf of 4 were randomly selected and placed in 6-well plates, with 30 zebrafish treated in each well (experimental group). The water quality for fish farming was as follows: 200 mg of readily soluble sea salt was added to every 1 L of reverse osmosis water; conductivity was 450-550 µS / cm; pH was 6.5-8.5; and hardness was 50-100 mg / L CaCO3. Water-soluble samples were administered (water-soluble samples of the compositions given in the experimental groups were added to the fish farming water; the treatment concentrations of the compositions in the fish farming water for each experimental group were as shown in Examples 1-6, Comparative Examples 2, and Comparative Example 4). A normal control group and a model control group were also set up, with a volume of 3 mL per well. Three biological replicates were performed. After treatment at 28℃ for 1 day, except for the normal control group, all other experimental groups were given water-soluble phenylhydrazine to establish a zebrafish anemia model. After treatment at 28℃ for another 8 hours, data were collected using a hemoglobin content assay kit and a multi-functional microplate reader to analyze the hemoglobin content in zebrafish. The statistical analysis results of these indicators were used to evaluate the efficacy of the samples in improving iron deficiency anemia. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0198] Among them, the dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); precision electronic balance (CP214, OHAUS, USA); ultrasonic cleaner (JP-010T, Shenzhen Jiemeng Cleaning Equipment Co., Ltd., China); 6-well plate (Zhejiang Beilanbo Biotechnology Co., Ltd., China); 96-well plate (NestBiotech, China).

[0199] Test results:

[0200] 1. Results of cardiac red blood cell color intensity

[0201] Under the experimental conditions, Examples 1, 2, 3, 4, 5, 6, Comparative Example 2, and Comparative Example 4 showed efficacy in improving iron deficiency anemia, while Comparative Example 1 and Comparative Example 3 showed no effect. Example 2 demonstrated superior efficacy in improving iron deficiency anemia compared to Examples 5, 6, Comparative Example 2, and Comparative Example 4. Example 3 showed superior efficacy compared to Examples 5, 6, Comparative Example 2, and Comparative Example 4. Example 4 showed superior efficacy compared to Comparative Example 2 and Comparative Example 4, but no statistically significant difference compared to Examples 5 and 6. The experimental results evaluating the efficacy of the samples in improving iron deficiency anemia (n = 10) are shown in Table 7. Typical images of zebrafish heart erythrocyte staining intensity after sample treatment are shown below. Figure 1 As shown.

[0202] Table 7

[0203]

[0204] Compared with the model control group, < 0.01, < 0.001;

[0205] Compared with Example 5, , ;

[0206] Compared with Example 6, # p < 0.05, ## p < 0.01;

[0207] Compared with Comparative Example 2, @ p < 0.05, @@ p < 0.01;

[0208] Compared with Comparative Example 4, ^ p < 0.05, ^^ p < 0.01;

[0209] 2. Hemoglobin content results

[0210] Since Comparative Examples 1 and 3 had no effect on enhancing the color intensity of cardiac erythrocytes, they were not included in the hemoglobin content determination. Under the experimental conditions, Examples 1, 2, 3, 4, 5, 6, Comparative Example 2, and Comparative Example 4 all showed the effect of increasing hemoglobin content; Example 2 showed a better effect than Examples 5, 6, Comparative Example 2, and Comparative Example 4; Example 3 showed a better effect than Examples 5, 6, Comparative Example 2, and Comparative Example 4; Example 4 showed a better effect than Examples 5, 6, Comparative Example 2, and Comparative Example 4. The experimental results evaluating the efficacy of the samples in improving iron deficiency anemia (n = 30) are shown in Table 8.

[0211] Table 8

[0212]

[0213] Compared with the model control group, < 0.01, < 0.001;

[0214] Compared with Example 5, , ;

[0215] Compared with Example 6, # p < 0.05, ## p < 0.01;

[0216] Compared with Comparative Example 2, @ p < 0.05;

[0217] Compared with Comparative Example 4, ^ p < 0.05, ^^ p < 0.01;

[0218] Based on the above results, the compositions of Examples 1-6 of this application have the effect of increasing hemoglobin content and cardiac erythrocyte staining intensity (β-casein:Poria cocos powder mass ratio ranges (0.2-60):1), among which Examples 2-4 (β-casein:Poria cocos powder mass ratio ranges (1-34.7):1) can significantly increase hemoglobin content and cardiac erythrocyte staining intensity compared with the comparative example and the model control group. It can be inferred that the compositions of the present invention can increase hemoglobin content, thereby promoting the increase of oxygen-carrying molecule content, restoring oxygen-carrying capacity, promoting the recovery of hematopoietic function, and thus improving the (iron deficiency) anemia phenotype.

[0219] The above embodiments illustrate and describe the main features and advantages of the present invention in detail. However, the present invention is not limited to the embodiments described. Those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of the present invention. All such equivalent modifications or substitutions are included within the scope defined by the claims of this application.

Claims

1. Use of a composition in the manufacture of a product for aiding in the prevention and / or amelioration of iron deficiency anemia, characterized in that, The composition consists of β-casein and Poria cocos extract; The mass ratio of β-casein to Poria cocos extract is (1-50):1; The Poria cocos extract is an extract obtained from Poria cocos through a water extraction process.

2. Use according to claim 1, characterized in that, The mass ratio of β-casein to Poria cocos extract is (1-34.7):

1.

3. Use according to claim 1, characterized in that, The mass ratio of β-casein to Poria cocos extract is (1-24):

1.

4. The application according to claim 1, characterized in that, The benefits of preventing and / or improving iron deficiency anemia include promoting red blood cell production.

5. The use according to claim 1, characterized in that, The benefits of preventing and / or improving iron deficiency anemia include promoting the recovery of hematopoietic function.

6. Use according to claim 1 or 4 or 5, characterized in that, The benefits of preventing and / or improving iron deficiency anemia include increasing hemoglobin levels.

7. A composition for aiding in the prevention and / or amelioration of iron deficiency anemia, characterized by comprising, The composition consists of β-casein and Poria cocos extract in a mass ratio of (1-50):1; the Poria cocos extract is an extract obtained from Poria cocos by water extraction.

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