Special dietary food for remodeling immunity and preparation scheme thereof

Abstract

The invention relates to the field of food science and technology, and discloses a special dietary food for remodeling immunity and a preparation scheme thereof.The special dietary food comprises a compound of immune globulin and Chinese herbal medicine extract, the immune globulin is extracted from bovine colostrum, and the Chinese herbal medicine extract comprises phellinus igniarius extract, ginseng extract and lucid ganoderma extract. The mass ratio of the immune globulin to the Chinese herbal medicine extract is 1: 1-1: 2; the immunoglobulin is extracted by the following steps: step 1, selecting bovine coloctrum collected within 24 hours as a raw material; 2, extracting the immune globulin at-40 DEG C by adopting a low-temperature extraction method; by combining the immune globulin and various Chinese herbal medicine extracts, a compound with a synergistic effect is provided. The immune globulin can activate the immune system of the body, and especially, the activity of immune cells is enhanced by enhancing the levels of IgG, IgA and IgM immune globulins, so that the immune function of the body is effectively improved.

Description

Technical Field

[0001] The present invention relates to the technical field of food science and technology, and specifically to a special dietary food for reshaping immunity and a preparation plan thereof. Background Art

[0002] With the rapid development of modern society and the change of lifestyle, the health of the immune system has gradually become the focus of people's attention. The immune system is an important line of defense for the human body to resist external pathogens, viruses, bacteria and other harmful substances. However, due to various factors such as environmental pollution, bad eating habits, and increased mental stress, the immune function gradually declines, making people more susceptible to infection and disease. Therefore, how to improve immunity in a natural and safe way has become a research hotspot in the field of medicine and health care. In this context, the regulation and enhancement of the immune system has become an important direction of research and development. In recent years, immunoglobulins (IgG, IgA, IgM, etc.) have been widely used in the research and development of immune enhancement products due to their important role in immune defense. Immunoglobulins can activate the body's immune response by increasing antibody levels. However, the use of a single immunoglobulin often cannot fully enhance immune function. Therefore, combining immunoglobulins with other natural ingredients to exert synergistic effects has become a new research idea.

[0003] There are many immune-enhancing products on the market, including health products with immunoglobulin as the main ingredient. In addition to immunoglobulin, some health products also add Chinese herbal extracts, such as ginseng, ganoderma lucidum, mulberry and so on, to enhance immunity. Chinese herbal medicine has certain advantages in enhancing immunity. Its natural ingredients can regulate the body's immune system, enhance the activity of immune cells, and improve the immune environment in the body. Some studies have shown that the complex of immunoglobulin and Chinese herbal ingredients can play a synergistic role and effectively enhance the body's immune defense capabilities. Common technical means include low-temperature extraction, supercritical extraction, spray drying, etc. These technologies can maintain the active ingredients of the raw materials while reducing the losses that may be suffered during the processing.

[0004] Although there are immune enhancement products of immunoglobulin and Chinese herbal medicine complexes in the prior art, there are still some shortcomings. First, the formulas of existing products are mostly simple mixtures of immunoglobulin and herbal extracts, lacking precise ratio and concentration control, resulting in unstable or difficult to quantify immune enhancement effects of the products. Second, the existing technology may lose active ingredients during extraction and processing, resulting in the final product being less effective than expected. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides a special dietary food for reshaping immunity and a preparation plan thereof, which solves the problem that the formulas of existing products are mostly simple mixtures of immunoglobulins and herbal extracts, lack precise proportion and concentration control, resulting in unstable or difficult to quantify immune-enhancing effects of the products.

[0006] To achieve the above objectives, the present invention is implemented through the following technical scheme: a special dietary food for reshaping immunity, the special dietary food comprising a complex of immunoglobulin and Chinese herbal extract, wherein the immunoglobulin is immunoglobulin extracted from bovine colostrum, the Chinese herbal extract comprises extracts of mulberry linterus, ginseng and ganoderma lucidum, and the mass ratio of immunoglobulin to herbal extract is 1:1 to 1:2.

[0007] Preferably, the immunoglobulin is extracted by the following steps: Step 1: Select bovine colostrum collected within 24 hours as raw material; Step 2, extracting immunoglobulin at -40°C using a low temperature extraction method; Step 3: Use high-speed centrifugation to remove impurities such as milk fat and lactose; Step 4: Use membrane filtration technology to concentrate the immunoglobulin solution to a concentration of 25%.

[0008] Preferably, the Chinese herbal medicine extract is subjected to supercritical The extracts are extracted by the extraction method and converted into powdery substances by spray drying technology.

[0009] Preferably, the herbal extracts include Phellinus linteus extract, Panax ginseng extract and Ganoderma lucidum extract, and the concentration of the extracts is 1% to 10% of the active ingredient content.

[0010] Preferably, the special dietary food is in capsule form, tablet form, liquid drink form or powder form.

[0011] The present invention also provides a method for preparing a special dietary food for remodeling immunity, comprising the following steps: Step 1: Select bovine colostrum collected within 24 hours as raw material and extract immunoglobulin by low-temperature extraction; Step 2: using high-speed centrifugal separation equipment to remove milk fat and lactose impurities, and concentrating immunoglobulins to a concentration of 25% by membrane filtration technology; Step 3: Select Chinese herbal medicines such as Phellinus linteus, Ginseng and Ganoderma lucidum, and use supercritical fluid to The active ingredients were extracted by extraction method and the herbal extracts were obtained by spray drying; Step 4, mixing the immunoglobulin and the herbal extract in a mass ratio of 1:1 to 1:2, and stirring at low temperature until uniform; Step 5, freeze-drying the complex to obtain a powdered complex; Step 6: Fill the complex into capsules, compress into tablets or convert into powder dosage form or liquid beverage dosage form to obtain the final product.

[0012] Preferably, the extraction concentration of the herbal extract is 1% to 10%.

[0013] Preferably, the mass ratio of the immunoglobulin to the herbal extract is 1:1 to 1:2, and the freeze-drying temperature of the complex is -40°C to -60°C.

[0014] Preferably, the freeze-drying process includes freezing the complex to -40°C, and then removing moisture through a process of reducing pressure and raising temperature, to finally obtain a stable powdered complex.

[0015] The present invention also provides a special dietary food for remodeling immunity prepared by the method, which is used for regulating the function of the immune system and enhancing immunity, and is particularly suitable for people with low immunity.

[0016] The present invention provides a special dietary food for remodeling immunity and a preparation method thereof. It has the following beneficial effects: 1. The present invention provides a synergistic complex by combining immunoglobulin with a variety of Chinese herbal extracts. Immunoglobulin can activate the body's immune system, especially by enhancing the levels of immunoglobulins such as IgG, IgA, and IgM to promote immune response; Chinese herbal extracts regulate the balance of the immune system through their natural active ingredients and enhance the activity of immune cells. The two work synergistically to effectively enhance the body's immune function.

[0017] 2. The immunoglobulin and Chinese herbal medicine complex of the present invention can enhance the body's immune defense ability and improve resistance to pathogens such as viruses and bacteria by regulating different stages of immune response. In addition, Chinese herbal medicine ingredients can regulate the immune system, achieve immune balance, avoid excessive immune response, and thus reduce the occurrence of immune system allergies, inflammation and other problems.

[0018] 3. The present invention adopts low temperature extraction and supercritical Modern technologies such as extraction and freeze-drying can effectively preserve the active ingredients in immunoglobulins and herbal extracts and reduce their loss during extraction and processing. The application of freeze-drying technology not only ensures the high stability of the final product, but also significantly extends the shelf life of the product. At the same time, the mass ratio and concentration of immunoglobulins and herbal extracts are limited, making the formula of this special dietary food more precise, ensuring the immune enhancement effect of each dosage form. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 The figure is a flow chart of the method of the present invention. DETAILED DESCRIPTION

[0020] The following will be combined with the drawings in the specification of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] Embodiment 1: Please see attached Figure 1 An embodiment of the present invention provides a special dietary food for reshaping immunity, the special dietary food comprising a complex of immunoglobulin and a Chinese herbal extract, wherein the immunoglobulin is immunoglobulin extracted from bovine colostrum, the Chinese herbal extract comprises extracts of mulberry linterus, ginseng and ganoderma lucidum, and the mass ratio of the immunoglobulin to the Chinese herbal extract is 1:1 to 1:2.

[0022] Immunoglobulins are extracted by the following steps: Step 1: Select bovine colostrum collected within 24 hours as raw material; Step 2, extracting immunoglobulin at -40°C using a low temperature extraction method; Step 3: Use high-speed centrifugation to remove impurities such as milk fat and lactose; Step 4: Use membrane filtration technology to concentrate the immunoglobulin solution to a concentration of 25%.

[0023] Chinese herbal medicine extracts are processed by supercritical The extracts are extracted by the extraction method and converted into powdery substances by spray drying technology.

[0024] The herbal extracts include Phellinus linteus extract, Ginseng extract and Ganoderma lucidum extract, and the concentration of the extracts is 1% to 10% of the active ingredient.

[0025] Special dietary foods are in the form of capsules, tablets, liquid drinks or powders.

[0026] Based on a special dietary food for reshaping immunity, this embodiment also provides a preparation method for a special dietary food for reshaping immunity, including the following steps: Step 1: Select bovine colostrum collected within 24 hours as raw material and extract immunoglobulin by low-temperature extraction; Step 2: using high-speed centrifugal separation equipment to remove milk fat and lactose impurities, and concentrating immunoglobulins to a concentration of 25% by membrane filtration technology; Step 3: Select Chinese herbal medicines such as Phellinus linteus, Ginseng and Ganoderma lucidum, and use supercritical fluid to The active ingredients were extracted by extraction method and the herbal extracts were obtained by spray drying; Step 4, mixing the immunoglobulin and the herbal extract in a mass ratio of 1:1 to 1:2, and stirring at low temperature until uniform; Step 5, freeze-drying the complex to obtain a powdered complex; Step 6: Fill the complex into capsules, compress into tablets or convert into powder dosage form or liquid beverage dosage form to obtain the final product.

[0027] Herbal extracts are extracted at concentrations ranging from 1% to 10%.

[0028] The mass ratio of the immunoglobulin to the herbal extract is 1:1 to 1:2, and the freeze-drying temperature of the complex is -40°C to -60°C.

[0029] The freeze-drying process involves freezing the complex to -40°C and then removing moisture through a process of reducing pressure and raising temperature to ultimately obtain a stable powdered complex.

[0030] A special dietary food for reshaping immunity is used to regulate the function of the immune system and enhance immunity, and is particularly suitable for people with low immunity.

[0031] In this embodiment, the purpose of step 1 is to extract immunoglobulins from bovine colostrum to provide important immune components for subsequent immune enhancement. Bovine colostrum is a natural immune source, and its rich immunoglobulins, especially IgG, can effectively enhance the body's immune response and have significant antiviral and antibacterial immune functions. This step efficiently extracts immunoglobulins from fresh bovine colostrum by low-temperature extraction, retaining its immune activity to the greatest extent.

[0032] As an option, colostrum should be collected within 24 hours. Since the concentration of immunoglobulins in colostrum is highest within 24 hours after parturition, choosing colostrum collected within this time window as the raw material can ensure the maximum immune components.

[0033] Specifically, the present invention extracts immunoglobulins by low-temperature extraction, and the low-temperature environment helps to effectively avoid the destruction of the active components of immunoglobulins by high temperature. Low-temperature extraction technology uses solvents or buffers in a temperature range of -40°C to -10°C, which can ensure the extraction rate and biological activity of immunoglobulins while avoiding protein denaturation or degradation caused by high-temperature treatment.

[0034] In one possible implementation, the specific operation of low-temperature extraction includes the following steps: First, the fresh colostrum is cooled to a predetermined temperature range through a cooling system, and then an appropriate solvent or buffer solution is added to allow it to react with the immunoglobulin in the colostrum. This process lasts for several hours to ensure that the immunoglobulin can be effectively dissolved in the solution.

[0035] For example, the buffer used may be phosphate buffered saline (PBS), which has a pH value between 7.2 and 7.4, is suitable for the extraction of immunoglobulins, and can effectively protect the natural conformation of immunoglobulins.

[0036] It should be noted that the source and quality of bovine colostrum have an important influence on the final extraction effect of immunoglobulins. Therefore, the present invention recommends using bovine colostrum with strictly controlled quality and meeting food or pharmaceutical grade standards as raw materials. The quality control of bovine colostrum includes the hygienic safety of its source, whether there is contamination, and the standardization of the immunoglobulin content in dairy products.

[0037] It is understood that the selection of solvent and its concentration, extraction time and other factors in the low temperature extraction process are crucial to the extraction efficiency of immunoglobulin and the quality of the final product. Therefore, the extraction conditions in the examples will be optimized and adjusted according to actual needs to ensure that the extraction rate of immunoglobulin reaches the maximum value.

[0038] In some embodiments, the present invention can also be combined with other auxiliary extraction techniques, such as ultrasound-assisted extraction or enzymatic-assisted extraction, to further improve the extraction efficiency of immunoglobulins. These auxiliary extraction techniques can increase the solubility of immunoglobulins by physical or chemical means under the premise of ensuring a low temperature environment, thereby improving the absorption rate of immunoglobulins.

[0039] It is understandable that the implementation of the low-temperature extraction method is not limited to the use of the above-mentioned buffer solution. Other suitable solvents or water-soluble liquids can also be used to extract immunoglobulins. The choice and ratio of solvents will also vary depending on the different types of herbs and immunoglobulins to ensure that immunoglobulins can be efficiently extracted from bovine colostrum.

[0040] It should be further explained that during the low-temperature extraction process, long-term high pressure or strong oscillation operations should be avoided, which may cause changes in the structure of immunoglobulins or loss of activity. Therefore, during the operation, the temperature, time and pressure of the extraction should be strictly controlled to ensure the optimal activity and quality of the immunoglobulins.

[0041] Finally, the immunoglobulin solution obtained by the low-temperature extraction method will become one of the basic raw materials for the special dietary food of the present invention, and provide necessary immune component support for the subsequent immune enhancement effect.

[0042] In this embodiment, the main purpose of step 2 is to remove impurities such as milk fat and lactose in bovine colostrum by physical and membrane filtration technology, and at the same time concentrate immunoglobulins to the required concentration, so as to provide high-purity immune components for the subsequent mixing of herbal extract complexes. This step uses a combination of high-speed centrifugation and membrane filtration, which can efficiently separate milk fat and lactose impurities and retain the activity and quality of immunoglobulins to the greatest extent.

[0043] As an option, the operation of step 2 can be divided into two stages: first, high-speed centrifugation is used to remove most of the milk fat and other solid impurities in the colostrum; then membrane filtration technology is used to further concentrate the immunoglobulins and remove lactose impurities. This combination can increase the concentration of immunoglobulins while maintaining the activity of immunoglobulins.

[0044] Specifically, the high-speed centrifugation technology used in this embodiment is based on the action of centrifugal force, and the centrifugal force generated by rotation separates different components in the solution. In this process, milk fat and larger particles of impurities will settle to the bottom of the container, while immunoglobulins will be concentrated in the upper liquid. The implementation of this step ensures that milk fat and other unnecessary components are effectively removed, thereby improving the purity of immunoglobulins.

[0045] In a possible implementation, the specific conditions of the centrifugal operation can be set as: a centrifugal speed of 5000 to 8000 rpm and a centrifugal time of 10 to 20 minutes to ensure a sufficient separation effect and avoid damage to the immunoglobulin due to excessive centrifugal force.

[0046] Exemplarily, the centrifuge used can be selected as a high-speed large-capacity centrifuge, which can complete the centrifugation of large batches of samples in a shorter time. In addition, the rotor type of the centrifuge should be selected according to the sample volume to ensure the best separation effect.

[0047] It should be noted that the effect of the centrifugation operation is closely related to the purity of the immunoglobulin. Therefore, the centrifugation speed and time during the operation need to be optimized according to the actual situation to avoid damage to the immunoglobulin and incomplete separation.

[0048] Next, the immunoglobulin solution is further refined through membrane filtration technology. Membrane filtration technology uses the principle of selective permeability to separate small molecules such as lactose and salts in the solution from immunoglobulins using membrane materials with a certain pore size. The selection of membrane pores is of great significance for the concentration of immunoglobulins. Specifically, the pore size of the membrane should be selected to be 0.1 to 0.5 microns, which can effectively filter out impurities such as lactose while retaining immunoglobulin molecules.

[0049] In some embodiments, the membrane filtration process may use an ultrafiltration membrane, the pore size of which can ensure that small molecules such as lactose are effectively removed, and the immunoglobulin can be concentrated to a desired concentration without destroying its activity.

[0050] It is understandable that membrane filtration technology can not only efficiently remove lactose and small molecule impurities, but also control the concentration of immunoglobulin as needed. In this embodiment, the concentration of the immunoglobulin solution after membrane filtration will be regulated to 25% to achieve the best biological activity and immune effect.

[0051] It should be further noted that the operating conditions during the membrane filtration process, including pressure, flow rate, etc., will also affect the concentration effect of immunoglobulins. These parameters should be reasonably adjusted and optimized according to different membrane types and target concentrations. Exemplarily, the operating pressure of membrane filtration can be set between 1 and 2 bar to ensure that the solution can be effectively filtered through the membrane material.

[0052] Through the combination of the above-mentioned high-speed centrifugation and membrane filtration technology, it is possible to remove impurities such as milk fat and lactose while ensuring the increase of immunoglobulin concentration, ultimately obtaining a high-purity, high-concentration immunoglobulin solution, providing high-quality raw materials for subsequent mixing and compounding with herbal extracts.

[0053] In this embodiment, the main purpose of step three is to extract the active ingredients from Chinese herbal medicines such as Phellinus linteus, ginseng, and Ganoderma lucidum by supercritical extraction to enhance the immunomodulatory function of special dietary foods. Supercritical extraction technology has high selectivity and efficiency, and can effectively extract active substances from herbs, especially for components with high lipophilicity or high molecular weight, and can be extracted under mild conditions to retain the biological activity of herbal components to the greatest extent.

[0054] Alternatively, this step can be performed by using carbon dioxide as a supercritical fluid in a supercritical state (critical temperature 31.1 , critical pressure 7.38MPa) to extract herbs such as Phellinus, Ginseng, and Ganoderma. This is because supercritical carbon dioxide ( ) has good solubility and selectivity, and is particularly suitable for extracting fat-soluble components in herbs, such as steroid compounds, plant glycosides, etc.

[0055] Specifically, the supercritical extraction process in this embodiment includes the following steps: First, the herbs such as Phellinus linteus, ginseng and Ganoderma lucidum are washed and dried, and then cut into small pieces of appropriate size to increase the surface area and ensure efficient dissolution of the effective ingredients during supercritical extraction. Then, the herbal sample is placed in the extraction chamber of the supercritical extraction equipment, and the flow rate and pressure of carbon dioxide are adjusted to ensure that the solvent plays the best extraction role under the supercritical state.

[0056] In one possible implementation, the extraction pressure of supercritical carbon dioxide can be set between 7.5 and 15 MPa, and the temperature can be maintained at 35 to 50 This operating condition ensures efficient extraction of active ingredients while avoiding damage to the active ingredients of the herbal medicine by excessively high temperatures. Different herbs may require different operating conditions, so in actual operation, they should be adjusted according to the chemical composition and properties of the specific herbs.

[0057] For example, the extraction time is usually between 2 and 6 hours. By controlling the time and temperature, the extraction rate of the active ingredients in the herbal medicine can be effectively improved, and its natural activity can be retained to the greatest extent. For example, in the extraction process of Ganoderma lucidum, a higher pressure and a lower temperature are selected to improve the extraction effect of its polysaccharides.

[0058] It should be noted that supercritical extraction does not use solvents during the extraction process, avoiding the risk of solvent residues and making the final extract safer and purer. Therefore, supercritical extraction technology is particularly suitable for the production of high-quality special dietary foods.

[0059] It is understandable that in actual operation, in order to improve extraction efficiency and economy, it is often necessary to perform step-by-step extraction, that is, first extract different types of active ingredients separately, and then perform subsequent concentration and purification. For example, in the extraction process, different pressure and temperature conditions can be selected to extract polysaccharides in Ganoderma lucidum, saponins in ginseng, polyphenol compounds in Phellinus igniarius, etc.

[0060] In some embodiments, in order to further improve the quality of the herbal extract, the supercritical extract can be further separated and purified by combining chromatographic separation technology. This can separate high-purity herbal active ingredients through column chromatography, thin layer chromatography, etc., further enhancing the immunomodulatory effect of the food.

[0061] It should be further explained that the quality and purity of herbal extracts have an important impact on the efficacy of subsequent special dietary foods. Therefore, during the operation, the parameters such as solvent flow, temperature, pressure, extraction time, etc. of supercritical extraction need to be precisely controlled to ensure the stability and activity of the extract.

[0062] The herbal extracts obtained by supercritical extraction can effectively retain the active ingredients in the herbs, including but not limited to polysaccharides, saponins, steroid compounds, plant glycosides, etc. These ingredients work together to enhance the immunomodulatory effect of special dietary foods and provide an important basis for the efficacy of the final product.

[0063] In this embodiment, the core goal of step 4 is to mix immunoglobulins and herbal extracts in a certain proportion to form a complex with remodeling immune function. This step is a key link to ensure the synergistic effect of immunoglobulins and herbal active ingredients and maximize their immunomodulatory effects. In order to ensure the uniform distribution and good interaction of herbal extracts and immunoglobulins in the final product, this step adopts low-temperature stirring, which can avoid thermal damage to immunoglobulins in a high-temperature environment and promote uniform fusion between the ingredients.

[0064] As an option, the mixing ratio of immunoglobulin to herbal extract is set to 1:1 to 1:2 to ensure that the active ingredients of both in the final product fully exert their immune enhancement effects. In some embodiments, the concentration of immunoglobulin is maintained at 25%, and the concentration of herbal extract is adjusted according to the actual extraction rate and the required dosage. According to this ratio relationship, the best synergistic effect between immunoglobulin and herbal extract can be achieved.

[0065] Specifically, the mixing steps used in this embodiment include the following key links: First, the concentrated immunoglobulin solution and the herbal extract solution are prepared separately. In order to ensure the uniformity after mixing, the immunoglobulin solution is usually in liquid form, and the herbal extract is concentrated after supercritical extraction. At this time, the immunoglobulin and the herbal extract are both in an appropriate concentration range, which can effectively avoid the failure of the components caused by too high or too low solution concentration.

[0066] In one possible implementation, the immunoglobulin solution and the herbal extract solution are mixed at a mass ratio of 1:1 to 1:2. In order to obtain more precise ratio control, the two liquids can be delivered by weighing and quantitative pumps, and the mixing ratio can be monitored in real time. During the mixing process, the immunoglobulin and herbal extract solutions can be stirred by a low-temperature stirrer, and the stirring temperature is usually set at 4 to 8 to ensure uniform mixing and avoid denaturation of immunoglobulins at high temperatures.

[0067] Exemplarily, the low-temperature stirring operation can be completed by a stainless steel stirrer, with a stirring speed of 200 to 500 rpm to ensure that the solution is fully mixed. It should be noted that low-temperature stirring can not only improve the mixing efficiency, but also effectively avoid the denaturation of immunoglobulins caused by high-temperature stirring, thereby ensuring its biological activity. For herbal extracts, the setting of stirring speed and time can ensure the effective fusion of herbal ingredients and immunoglobulins without destroying certain sensitive ingredients in the herbs due to mechanical forces.

[0068] It is understood that in the process of mixing immunoglobulin and herbal extract, in addition to stirring, time control is also an important factor to ensure uniform mixing. The stirring time is usually 30 minutes to 1 hour to ensure that all ingredients are evenly distributed. During this time period, the active ingredients of immunoglobulin and herbal extract can form a stable complex, thus laying the foundation for the subsequent freeze-drying process.

[0069] It should be further explained that in order to avoid precipitation or stratification of immunoglobulin and herbal extract, a surfactant or stabilizer is used in this embodiment to improve the stability of the complex. Exemplary stabilizers can be glycerol or propylene glycol, which can not only improve the stability of the solution, but also enhance the compatibility of immunoglobulin and herbal ingredients. During the mixing process, the addition ratio of these stabilizers is generally 0.1% to 1%.

[0070] Through the above technical means, immunoglobulin and herbal extracts can be evenly mixed and their biological activity and immune enhancement effects can be maintained. The successful implementation of this step provides a strong guarantee for the subsequent freeze-drying process and the dosage form conversion of the final product, ensuring the stability and effectiveness of the complex.

[0071] In this embodiment, the core goal of step five is to freeze-dry the mixed immunoglobulin and herbal extract complex to obtain a powdered final product. Freeze-drying can not only maintain the biological activity of immunoglobulin and the pharmacological effects of herbal ingredients, but also significantly extend the shelf life of the product. The freeze-drying process removes moisture in a low-temperature vacuum environment, which minimizes the damage to the components by heat treatment and ensures the effectiveness and stability of the complex.

[0072] As an option, the freeze-drying process is generally divided into three main steps: freezing, heating dehydration and drying. In the specific implementation process, the compound needs to be pre-cooled first to ensure that it reaches a suitable freezing temperature. Usually, the freezing temperature can be set at -40 To -50 , and the composite needs to be frozen quickly to prevent moisture from damaging the composite structure in the ice crystal state.

[0073] Specifically, in this embodiment, the complex goes through the following stages during the freeze-drying process: Freezing stage: During this stage, the compound is cooled to -40 To -50 , and keep it frozen for a certain time. The freezing speed needs to be fast enough to avoid particle destruction caused by water crystallization, which is crucial to maintaining the effectiveness of immunoglobulins and herbal extracts. During the freezing process, it can be carried out through low-temperature cooling equipment to ensure that the complex reaches the desired low temperature range.

[0074] Temperature dehydration stage: After freezing, the compound enters the temperature dehydration stage. In this stage, the compound is kept at low temperature for a period of time to stabilize the morphology and properties before and after freeze-drying. The temperature of temperature dehydration is controlled between -30°C and -15°C to prevent thermal degradation of the components due to high temperature.

[0075] Drying stage: In this stage, the compound is dried under vacuum. The water in the compound is removed by vacuum, and the compound is finally transformed into a powder product. Temperature control during the drying process is critical. Too high a temperature will cause the denaturation of immunoglobulins, while too low a temperature may result in incomplete drying. Generally speaking, the drying temperature can be controlled between -10°C and 0°C, and the entire drying process may last 12 to 24 hours, depending on the initial moisture content of the compound and the required degree of drying.

[0076] In one possible implementation, the freeze-drying equipment may be a vacuum freeze dryer, which can accurately control the temperature of each stage through a temperature control system to ensure that the removal of water does not affect the biological activity of the complex. During the freeze-drying process, the vacuum degree is usually set to 0.1 to 0.5 Pa to ensure effective removal of water under low temperature conditions. It should be noted that the regulation of the vacuum degree is crucial to the dehydration efficiency. A lower vacuum degree helps to accelerate the removal of water while avoiding overheating during the drying process.

[0077] For example, the powder compound obtained after freeze-drying has excellent fluidity and solubility, and can be further processed according to the subsequent product form requirements. For products that need further processing, the powder can be tableted or converted into a liquid dosage form. In this process, the freeze-dried powder material provides an efficient and stable raw material for subsequent dosage form conversion.

[0078] It is understandable that the key to freeze-drying is to control the temperature and time at each stage to avoid thermal damage and incomplete removal of moisture. Therefore, in actual operation, the freeze-drying equipment needs to have precise temperature and vacuum control functions to ensure the controllability of the process and the final quality of the compound.

[0079] It should be noted that, in certain embodiments, in order to further improve the stability and solubility of the freeze-dried product, a small amount of protective agent may be added. Common protective agents include sucrose, glycerol, etc., which can provide additional protection for the complex during the freeze-drying process to prevent the degradation of immunoglobulins and herbal ingredients. In certain embodiments, the amount of these protective agents added may be 0.5% to 3% to ensure the stability of the complex and the efficacy under long-term storage conditions.

[0080] In this embodiment, the core of step six is ​​to convert the lyophilized immunoglobulin and herbal extract complex into a suitable final product form according to different dosage form requirements, including but not limited to capsules, tablets, powder dosage forms or liquid beverage dosage forms. The purpose of this step is to ensure the availability of the complex, facilitate patient administration and meet market demand. According to different consumer needs, a suitable dosage form can be selected for preparation to achieve an optimized user experience.

[0081] As an option, the final product form of the composite can be selected from the following forms: capsule dosage form, compressed tablet dosage form, powder dosage form and liquid beverage dosage form. Different dosage forms have different advantages and are suitable for different usage scenarios and consumer preferences. In this embodiment, the conversion process of the above-mentioned dosage forms is mainly considered. During the specific implementation, the appropriate dosage form is selected for production according to the market positioning and demand of the product.

[0082] Specifically, in this embodiment, the freeze-dried composite must first undergo necessary processing to ensure that its quality meets the requirements of the final product. For example, the composite can be ground, sieved, etc. to obtain a suitable particle size for subsequent dosage form conversion. For capsule dosage forms, the composite powder needs to meet the requirements of capsule filling, and the particle size is usually controlled at 30 to 100 microns to ensure good fluidity and filling properties. For tablet dosage forms, the particle size of the composite is usually controlled at 50 to 150 microns to ensure smooth operation and stability during tableting.

[0083] In one possible implementation, during the preparation of the complex, a certain proportion of excipients may need to be added according to the specific requirements of capsules, tablets, and powder dosage forms. For example, excipients commonly used in tablets, such as lactose and starch, can improve tableting performance and enhance dosage form stability. For powder dosage forms, a small amount of vulcanizing agent, such as silicon dioxide, can be added to improve its fluidity. For liquid beverage dosage forms, an appropriate amount of solvents and sweeteners, such as glycerin, honey, etc., can be added to ensure the acceptability of the taste and the effective dissolution of the complex.

[0084] Exemplarily, when the compound is filled into a capsule dosage form, an automatic capsule filling device is used. During this process, the compound powder is accurately filled into each capsule to ensure that the content of the active ingredient in each capsule meets the predetermined standard. The material of the capsule can be a transparent or opaque capsule shell, and common materials include gelatin or plant capsule shells to meet the needs of different consumers.

[0085] It should be noted that the preparation process of tablets may require the following steps: first, the freeze-dried compound is crushed or ground to obtain a fine powder, which is then mixed evenly with other excipients and compressed using a tablet pressing device to form a stable tablet. During this process, the compression force is adjusted to ensure that the hardness and disintegration time of the tablets meet the desired effect. The disintegration time of the tablet is usually controlled between 5 and 15 minutes to ensure that the active ingredients of the compound can be quickly released and absorbed by the human body.

[0086] In another embodiment, the preparation of the liquid beverage dosage form requires mixing the freeze-dried compound with an appropriate solvent (such as water or liquid additives) through liquid mixing technology, adjusting the pH value and stability, and ensuring the taste and effect of the liquid beverage. The liquid beverage formula can also add auxiliary materials such as sweeteners and flavorings as needed to improve the taste and enhance consumer acceptance.

[0087] It is understandable that when selecting the final product form, the physical properties of the complex (such as particle size, solubility, etc.) and consumer usage needs will be important factors affecting the selection. Each dosage form needs to be optimized according to its application scenario, target market and consumer habits to ensure that the final product can maximize its immune-enhancing effect while providing a good user experience.

[0088] It should be noted that in order to improve the stability of the complex in different dosage forms, the packaging may need to be optimized. For capsule and tablet products, aluminum-plastic packaging or bottle packaging can be used to prevent moisture, seal and ensure long-term stability. For liquid drinks, bottles, bags or tea bags can be used for packaging to ensure the convenience of the product and the convenience of consumers to carry.

[0089] For example, during the production process of the liquid beverage dosage form, high shear mixing technology can be used to achieve uniform mixing of the complex and the liquid solvent to ensure that the ingredients of the immunoglobulin and herbal extract in each bottle of beverage are evenly distributed, providing stable efficacy.

[0090] In this embodiment, step seven mainly involves the quality control and testing process of the final product of the composite. Through strict quality control measures, it is ensured that each batch of the final product can meet the quality standards and have stable immune function and good consumer experience. This step is crucial because only by ensuring that the quality of the final product meets the expected requirements can it remain competitive in the market and win the trust of consumers.

[0091] As an option, the quality control and testing process in this embodiment includes raw material testing, key parameter monitoring during the production process, and multiple quality tests of the final product. Specifically, quality control measures usually cover the following aspects: raw material testing, production process control, final product inspection, stability testing, etc.

[0092] In one possible implementation, first, all raw materials, including bovine colostrum, herbal extracts (such as mulberry, ginseng, and ganoderma), and excipients, need to be tested according to predetermined quality standards. For example, the content of immunoglobulins and the content of active ingredients in herbal extracts (such as ginsenosides, ganoderma polysaccharides, etc.) need to be analyzed in the laboratory to ensure that they meet the requirements for use. Common analytical methods include high performance liquid chromatography (HPLC), mass spectrometry (MS), ultraviolet visible spectrophotometry (UV-Vis), etc.

[0093] For example, for the detection of immunoglobulins in bovine colostrum, the concentration of immunoglobulins can be quantitatively detected by ELISA (enzyme-linked immunosorbent assay). By comparing with the standard curve, it can be determined whether the immunoglobulin content reaches 25% to ensure its activity and effectiveness. At the same time, the active ingredients in herbal extracts (such as polysaccharides of mulberry, saponins of ginseng, polysaccharides of ganoderma lucidum, etc.) also need to be quantitatively detected by the above analytical methods to ensure that each ingredient meets the pharmacopoeia or industry standards.

[0094] It should be noted that during the production process, key production links need to be monitored to ensure the controllability of the operation process and the uniformity of the product. For example, during the extraction of immunoglobulins, the temperature and centrifugal speed during low-temperature extraction and centrifugation need to be precisely controlled to prevent the denaturation or destruction of immunoglobulins. During the herbal extraction process, the temperature and pressure conditions of the supercritical extraction method also need to be strictly controlled to ensure the quality and effectiveness of the extract.

[0095] Specifically, the final product of the complex also needs to undergo multiple quality tests. First, the composition analysis of the complex is the basis, including the content determination of immunoglobulins and herbal extracts. Secondly, the physical and chemical properties of the final product (such as moisture content, solubility, particle size, etc.) also need to be tested. These tests can be completed using equipment such as particle size analyzers and moisture meters. By controlling the size and moisture content of the complex particles, the stability and convenience of the product can be improved.

[0096] For example, tablet products need to be tested for disintegration time and hardness. Generally, the disintegration time should be controlled within 5 to 15 minutes, and the hardness should meet the pharmacopoeia standards to ensure the ease of use and dissolution of the tablets. For products in the form of liquid drinks, it is necessary to test their pH value, solubility, taste and other indicators to ensure their palatability and consumer acceptance.

[0097] Furthermore, in the testing of the final product, a bioactivity test should also be conducted, that is, to verify the immune enhancement effect of the immunoglobulin and herbal extract complex through cell experiments or animal experiments. This can be evaluated by measuring the changes in immune factors in serum or through immune-related functional experiments (such as cytokine secretion, T cell activity detection, etc.).

[0098] It is understandable that quality control and final product testing are not only to ensure that the product meets the standards, but also to verify the product's immune remodeling effect through bioactivity testing, dissolution testing, etc., to ensure that it can achieve the expected health benefits in actual application.

[0099] It should be noted that during long-term storage or transportation, product stability testing is also an important part that cannot be ignored. At this time, the product should be subjected to accelerated aging tests, including stability tests under conditions of high temperature and high humidity, to ensure the long-term effectiveness of the product. For capsules or tablets, the temperature and humidity control of the storage environment is very important, so it is necessary to verify the stability of the final product in different environments through packaging sealing tests, stability tests, etc.

[0100] Comparative Example 1: The formula of the present invention comprises immunoglobulin (immunoglobulin extracted from bovine colostrum) and Chinese herbal extracts (such as Phellinus linteus, ginseng, and Ganoderma lucidum) mixed in a certain proportion to form a complex. In order to compare the effects of the formula of the present invention, the following two groups of replacement formulas were designed: Control group formula 1: The mass ratio of immunoglobulin to Chinese herbal extract was 1:3, that is, the amount of immunoglobulin was three times that of the herbal extract.

[0101] Control group formula 2: The mass ratio of immunoglobulin to Chinese herbal extract is 2:1, that is, the amount of immunoglobulin is twice that of the herbal extract.

[0102] Comparative Example 2: Step replacement experiment comparison In addition to replacing the formulation, the implementation process can choose different extraction methods or processes to evaluate the effects of these alternative methods. Consider the following two alternative steps: Control group step 1: immunoglobulin extraction adopts room temperature extraction method instead of low temperature extraction method in the present invention.

[0103] Control group Step 2: Herbal extraction was not done using supercritical extraction but using conventional solvent extraction.

[0104] Experimental design Through the combination of different formulas or steps, a series of experiments were conducted to compare the effects of different solutions. Each experimental group and control group were subjected to the following tests: Immune activity test: The immune remodeling effect is evaluated by measuring the effects of immunoglobulins and herbal extracts on the activity of immune cells (such as T cells, B cells, and macrophages).

[0105] Cytokine secretion level: The changes in cytokines (such as IL-2, TNF-α, IFN-γ, etc.) in serum are measured by ELISA to evaluate the intensity of the immune response.

[0106] Dissolution rate: The dissolution rate of the complex was tested to evaluate its bioavailability.

[0107] Stability test: Through accelerated aging test, the stability of the product under different storage conditions is tested.

[0108] Sensory evaluation: evaluates the consumer experience of the final product in terms of taste, color, smell, etc.

[0109] Table 1 Experimental results analysis Immune activity: The immunoglobulin and herbal extract complex of the present invention has the strongest immune activity, with a T cell proliferation rate of 85%, significantly higher than the control group formula 1 (75%) and formula 2 (70%). This result shows that the reasonable ratio of immunoglobulin to herbal extract has a significant effect on the promotion of immune response.

[0110] Cytokine level: The IL-2 level in the present example is 200 ng / mL, which is much higher than that in other control groups. The secretion level of cytokines is closely related to immune activity, so this data further verifies the advantages of the present formula in activating the immune system.

[0111] Dissolution rate: The dissolution rate of the embodiment of the present invention is 85%, which is higher than 80% (Formula 1) and 78% (Formula 2) of the control group. The improvement of the dissolution rate means that the complex of the present invention has higher bioavailability in the body and can better play the role of immune remodeling.

[0112] Sensory evaluation: Although the taste score of the example of the present invention was high (8.5 points), the taste scores of the control group formula 1 and formula 2 were slightly lower. This may be related to the different proportions of herbal ingredients in the formula. The taste of herbal medicine is stronger, which may affect the taste of the final product.

[0113] Stability test: The stability test of the embodiment of the present invention performed best, and after 6 months of storage, the product did not change significantly. The control group products showed different degrees of changes in stability, especially the product of the control group using the traditional solvent extraction method in step 2, which had poor stability and underwent significant changes.

[0114] in conclusion Based on the above experimental results, the following conclusions can be drawn: Formula comparison: The immunoglobulin in the embodiment of the present invention and the herbal extract (Phellinus linteus, Ginseng, Ganoderma lucidum) mixed in a ratio of 1:1 to 1:2 have the best effect. Compared with other formulas (such as 1:3, 2:1 ratio), the embodiment of the present invention shows obvious advantages in immune activity, cytokine level, dissolution rate, etc.

[0115] Comparison of steps: Compared with traditional room temperature extraction and solvent extraction, low temperature extraction and supercritical extraction can better maintain the activity of immunoglobulins and the effective ingredients of herbal extracts, and have better stability.

[0116] Therefore, the embodiments of the present invention are superior to the control group in all aspects, proving the advantages of the formula and preparation method of the present invention in immune remodeling and final product quality control. This provides strong experimental support for the present invention and further verifies the innovation and practical application value of the present invention.

[0117] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A special dietary food for remodeling immunity, characterized in that: The special dietary food comprises a complex of immunoglobulin and Chinese herbal extract, wherein the immunoglobulin is extracted from bovine colostrum, the Chinese herbal extract comprises extracts of Phellinus linteus, ginseng and Ganoderma lucidum, and the mass ratio of immunoglobulin to the Chinese herbal extract is 1:1 to 1:

2.

2. The special dietary food for remodeling immunity according to claim 1, characterized in that: The immunoglobulin is extracted by the following steps: Step 1: Select bovine colostrum collected within 24 hours as raw material; Step 2, extracting immunoglobulin at -40°C using a low temperature extraction method; Step 3: Use high-speed centrifugation to remove impurities such as milk fat and lactose; Step 4: Use membrane filtration technology to concentrate the immunoglobulin solution to a concentration of 25%.

3. The special dietary food for remodeling immunity according to claim 1, characterized in that: The Chinese herbal medicine extract is passed through a supercritical The extracts are extracted by the extraction method and converted into powdery substances by spray drying technology.

4. The special dietary food for remodeling immunity according to claim 1, characterized in that: The herbal extracts include mulberry linterus extract, ginseng extract and ganoderma lucidum extract, and the concentration of the extracts is 1% to 10% of the active ingredient content.

5. The special dietary food for remodeling immunity according to claim 1, characterized in that: The special dietary food is in the form of capsules, tablets, liquid drinks or powders.

6. A method for preparing a special dietary food for reshaping immunity, according to the special dietary food for reshaping immunity according to any one of claims 1 to 5, characterized in that: The following steps are involved: Step 1: Select bovine colostrum collected within 24 hours as raw material and extract immunoglobulin by low-temperature extraction; Step 2: using high-speed centrifugal separation equipment to remove milk fat and lactose impurities, and concentrating immunoglobulins to a concentration of 25% by membrane filtration technology; Step 3: Select Chinese herbal medicines such as Phellinus linteus, Ginseng and Ganoderma lucidum, and use supercritical fluid to The active ingredients were extracted by extraction method and the herbal extracts were obtained by spray drying; Step 4, mixing the immunoglobulin and the herbal extract in a mass ratio of 1:1 to 1:2, and stirring at low temperature until uniform; Step 5, freeze-drying the complex to obtain a powdered complex; Step 6: Fill the complex into capsules, compress into tablets or convert into powder dosage form or liquid beverage dosage form to obtain the final product.

7. The method for preparing a special dietary food for remodeling immunity according to claim 6, characterized in that: The herbal extract has an extraction concentration of 1% to 10%.

8. The method for preparing a special dietary food for remodeling immunity according to claim 6, characterized in that: The mass ratio of the immunoglobulin to the herbal extract is 1:1 to 1:2, and the freeze-drying temperature of the complex is -40°C to -60°C.

9. The method for preparing a special dietary food for remodeling immunity according to claim 6, characterized in that: The freeze-drying process includes freezing the complex to -40°C, and then removing moisture through a process of reducing pressure and raising temperature, and finally obtaining a stable powdered complex.

10. A special dietary food for remodeling immunity prepared according to the method of any one of claims 1 to 9, characterized in that: It is used to regulate the function of the immune system and enhance immunity, and is especially suitable for people with low immunity.

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