Medicinal and edible health-care composition for enhancing immunity and preparation method of medicinal and edible health-care composition

Abstract

The invention belongs to the technical field of medicinal and edible health-care food, and particularly relates to a medicinal and edible health-care composition capable of enhancing immunity and a preparation method of the medicinal and edible health-care composition. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 35-45 parts of ginseng, 30-40 parts of lucid ganoderma, 30-45 parts of cistanche, 65-75 parts of rhizoma polygonati, 40-50 parts of radix polygonati officinalis, 50-60 parts of poria cocos, 80-100 parts of Chinese yam, 50-60 parts of gordon euryale seed, 50-60 parts of lotus seed, 180-220 parts of soybean peptide, 12-18 parts of galangal, 6-12 parts of clove and 6-12 parts of nutmeg. According to the health-care composition taking the medicinal and edible raw materials and the soybean peptide as the core, the mixing problem is solved by virtue of a specific ratio and process synergy and by taking the soybean peptide as a structured carrier, the activity is kept after the tail section of volatile oil, warm tonifying and yin nourishing balance is realized, the immunity is stably improved, and the product stability and industrialization consistency are both considered.

Description

Technical Field

[0001] This invention belongs to the field of food and medicine homology health food technology, specifically relating to a food and medicine homology health food composition for enhancing immunity and its preparation method. Background Technology

[0002] As society's population ages, the decline in immune function related to aging is becoming increasingly prominent. Among these factors, the gradual decline in immune function due to natural aging in middle-aged and elderly individuals has become a core factor affecting their health. From a physiological and pathological perspective, this process is called "immunoaging," characterized by weakened immune cell function, slowed and easily disordered immune responses, leading to a decrease in the body's ability to defend against pathogens, a weakened response to vaccines, and an increase in chronic low-grade inflammation, becoming a common contributing factor to the development of various age-related diseases (such as respiratory infections, metabolic diseases, and tumors). In the traditional Chinese medicine (TCM) system, this phenomenon corresponds to the pathogenesis of spleen and kidney deficiency. The *Huangdi Neijing* states, "At forty, the yin energy is halved, and daily life declines." This clearly indicates that after middle age, the kidney essence, the foundation of innate constitution, gradually depletes, while the spleen and stomach's digestive function, the foundation of acquired constitution, weakens accordingly. This results in insufficient production of qi and blood, leading to a decline in the body's defense function and symptoms such as fatigue, loss of appetite, aversion to cold, susceptibility to colds, and prolonged illness.

[0003] In response to the need for conditioning the declining immune function of middle-aged and elderly people, relevant conditioning programs based on food-medicine homology have been extensively studied. However, existing technical solutions still have several structural limitations. First, in terms of program design philosophy, most programs fail to fully align with the complex physical characteristics of middle-aged and elderly people, who often exhibit a mixture of deficiency and excess, and multiple organ decline. One type of program adheres rigidly to traditional tonifying approaches, excessively focusing on the warming and tonifying effects of single precious medicinal materials such as ginseng, deer antler, and Ganoderma lucidum. These materials are often potent and have a single formula, neglecting the physiological characteristics of the spleen and stomach's inability to digest and transform nutrients in middle-aged and elderly individuals. This can easily lead to the phenomenon of "inability to tolerate tonics," manifesting as adverse reactions such as fever, abdominal distension, and loss of appetite, affecting the sustainability of the conditioning. Another type of program adopts a single supplementation model from modern nutrition, such as simply supplementing with protein (soy protein powder), multivitamins, or trace elements. While this can provide basic nutritional support, it deviates from the core ideas of "differentiated treatment based on syndrome differentiation" and "holistic regulation" in traditional Chinese medicine. It cannot systematically balance the core pathogenesis of spleen and kidney deficiency, making it difficult to rebuild the immune system's balanced regulatory network. Summary of the Invention

[0004] In view of the shortcomings of the prior art, the purpose of this invention is to provide a medicinal and edible health care composition that enhances immunity and its preparation method.

[0005] The technical effects described in this invention are achieved through the following technical solution: a medicinal and edible health-preserving composition for enhancing immunity, comprising the following raw materials in parts by weight: 35-45 parts ginseng, 30-40 parts Ganoderma lucidum, 30-45 parts Cistanche deserticola, 65-75 parts Polygonatum sibiricum, 40-50 parts Polygonatum odoratum, 50-60 parts Poria cocos, 80-100 parts Dioscorea opposita, 50-60 parts Euryale ferox, 50-60 parts Nelumbo nucifera, 180-220 parts soybean peptides, 12-18 parts Alpinia galanga, 6-12 parts cloves, and 6-12 parts nutmeg; Preferably, the immune-enhancing food-medicine health-preserving composition comprises the following ingredients in parts by weight: 45 parts ginseng, 40 parts Ganoderma lucidum, 45 parts Cistanche deserticola, 75 parts Polygonatum sibiricum, 50 parts Polygonatum odoratum, 50 parts Poria cocos, 80 parts Dioscorea opposita, 50 parts Euryale ferox, 50 parts Nelumbo nucifera, 220 parts soybean peptides, 12 parts Alpinia galanga, 6 parts cloves, and 6 parts nutmeg. Preferably, the immune-enhancing food-medicine health-preserving composition comprises the following ingredients in parts by weight: 40 parts ginseng, 35 parts Ganoderma lucidum, 35 parts Cistanche deserticola, 70 parts Polygonatum sibiricum, 45 parts Polygonatum odoratum, 55 parts Poria cocos, 90 parts Dioscorea opposita, 55 parts Euryale ferox, 55 parts Nelumbo nucifera, 200 parts soybean peptides, 15 parts Alpinia galanga, 8 parts cloves, and 8 parts nutmeg. Preferably, the above-mentioned immune-enhancing food-derived health-preserving composition further comprises excipients acceptable in the food industry; the excipients are selected from one or more of fillers, flow aids, and shaping agents; Preferably, another aspect of the present invention provides a method for preparing a medicinal and edible health-promoting composition that enhances immunity, specifically comprising the following steps: S101: Ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia officinarum are selected, washed, coarsely crushed to 5mm, dried with hot air at 60℃ until the moisture content is ≤8%, and set aside; cloves and nutmeg are selected, pulverized at low temperature at 20℃, and passed through a 60-mesh sieve, and set aside. S102: Mix the ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia galanga processed in step S101, add 8 to 10 times the amount of purified water, soak for 30 minutes, perform two extractions, combine the extracts, pass through a 200-mesh sieve to obtain an aqueous extract. S103: Concentrate the aqueous extract from step S102 under reduced pressure to a relative density of 1.05–1.1; add anhydrous ethanol to bring the final ethanol concentration of the system to 60–80%; let stand at 4–10°C for 8–16 hours; centrifuge to collect the precipitate; redissolve the precipitate in twice the mass of purified water. S104: The reconstituted solution from step S103 is concentrated under vacuum at 55-65℃ to a relative density of 1.1-1.15, cooled to 45℃, and 30-60% of the total soybean peptides are added under paddle stirring at 60-120 rpm. The mixture is stirred for 15-30 minutes until the system is homogeneous and free of obvious agglomeration, thus obtaining the peptide-extract composite soft material. S105: Add the remaining soybean peptides to the peptide-extract composite soft material from step S104, then add filler excipients, extrude and granulate, with a sieve aperture of 0.8-1.5 mm, boil dry, with an inlet air temperature of 60-70℃, until the moisture content is ≤5%; after drying, cool to 30℃, granulate and pass through a 30-mesh sieve. S106: Add the dried granules from step S105 into a mixer and premix for 15-30 minutes. After the material temperature is ≤35℃, add the clove powder and nutmeg powder pretreated in step S101, as well as anti-caking excipients, and continue mixing for 10-15 minutes. During the mixing process, the material temperature is controlled to be ≤35℃. Then, irradiate to sterilize and obtain a medicinal and edible health care composition. Preferably, in step S102, the specific parameters for the two extractions are: the first extraction at 85–95°C for 1.5–2 hours; and the second extraction at 90–100°C for 1–1.5 hours. Preferably, in step S103, the centrifugation parameters are: 4000-8000 rpm, 10-20 min; It should be noted that in steps S103 and S104, the relative density is measured at a temperature of 60°C. Preferably, in step S105, the filler is one or more of maltodextrin, pregelatinized starch, microcrystalline cellulose, resistant dextrin, polydextrose, and inulin; more preferably, it is a mixture of maltodextrin and pregelatinized starch in a mass ratio of 2:1. Preferably, in step S105, the total amount of the filler added is 8-15 wt%; Preferably, in step S106, the anti-caking additive is either silica or tricalcium phosphate; more preferably, silica. Preferably, in step S106, the total amount of the anti-caking excipient is 0.5–2 wt%. Preferably, the amount of excipients added in steps S105 and S106 is based on the total dry matter mass of the raw materials. Preferably, in step S106, the parameters for irradiation sterilization are: Co60, dose 6-8 kGy.

[0006] The beneficial effects of this invention are as follows: Compared with existing technologies, this invention provides an immune-enhancing health care composition with a variety of medicinal and edible plant raw materials and soybean peptides as the core. It constructs a synergistic system with specific ratios and specific processes locked together to meet the coupled needs of four objectives: "enrichment and stabilization of immune-active components, nutritional support and easy absorption, preservation of volatile oil flavor and activity, and microbial safety and heat sensitivity protection". This results in a comprehensive improvement in terms of taste, dispersion uniformity, activity retention and product stability, and has good industrial consistency and repeatability. In terms of component synergy, this invention uses medicinal and edible raw materials with polysaccharide / polysaccharide conjugate active ingredients, such as Ganoderma lucidum, Cistanche deserticola, and Polygonatum sibiricum, as key supporting units for immune regulation. It uses medicinal and edible substances that invigorate the spleen and replenish qi without causing stagnation, such as Dioscorea opposita, Poria cocos, Euryale ferox, and Nelumbo nucifera, as supporting units for the body's constitution and digestion and absorption. Furthermore, it uses warming and qi-regulating raw materials such as ginseng and Alpinia galanga to balance the overall qi mechanism and metabolic state. Polygonatum odoratum and Polygonatum sibiricum provide nourishing and moisturizing characteristics, thus forming a combined logic of "strengthening the body's resistance, invigorating the spleen and replenishing qi, and warming and moisturizing in harmony." Compared to simply emphasizing warming or nourishing, this invention reduces the irritation and tolerance problems caused by excessive bias through the balanced combination of warming and nourishing yin, and replenishing and invigorating the spleen and regulating qi. This allows immune support to shift from "short-term stimulation" to "a more stable overall improvement," demonstrating the overall synergistic advantage within the optimal ratio window.

[0007] More importantly, this invention elevates soybean peptides from a conventional nutritional supplement ingredient to a structured synergistic carrier for the system. During preparation, concentrated extract is first compounded with a portion of soybean peptides at a suitable temperature, allowing polysaccharides, saponins, and other water-soluble / amphiphilic components to be uniformly adsorbed and dispersed on the peptide matrix, forming a stable composite material. This compounding process, on the one hand, suppresses phenomena such as localized over-wetting, clumping, wall adhesion, and uneven loading that easily occur when the extract directly contacts the powder; on the other hand, it leverages the film-forming and dispersing properties of peptides to improve particle structure stability and reconstitution consistency, thereby making it easier for the active ingredients to maintain a uniform distribution across different batches and different particle sizes. Thus, this invention achieves a synergistic closed loop of active ingredient enrichment, nutritional matrix support, and controllable process shaping, avoiding the contradictory chain in traditional formulations where concentrated extracts are more difficult to mix, longer mixing time leads to clumping, and larger particles are more difficult to dissolve. To address the issues of easy loss of volatile oil components in spices, easy cross-contamination of flavors, and natural conflicts with the heating process, this invention employs a processing strategy of low-temperature pulverization, airtight and light-proof storage, and final addition. During the final mixing stage, by controlling the temperature rise and mixing window of the materials, the volatile active components of cloves and nutmeg are prevented from undergoing prolonged water decoction and high-temperature drying, thus reducing the risk of volatilization loss and thermal degradation from the source. Simultaneously, this final addition strategy is coupled with the aforementioned "peptide-extract composite carrier": since the extract has been uniformly carried by the peptide matrix and its particle structure has been completed, the spice powder is more easily uniformly dispersed and its flavor stabilized during the lower-temperature final mixing stage, reducing the irritation and taste fluctuations caused by localized concentrations, thereby achieving a comprehensive effect that balances flavor and activity. Attached Figure Description

[0008] Figure 1 These are graphs showing the results of accelerated stability testing of the health care compositions of Examples 1-3 and Comparative Examples 1-5 of the present invention under the influence of moisture changes. Detailed Implementation

[0009] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Unless otherwise specified, the raw materials involved in the present invention are all purchased through conventional commercial channels. Experimental methods without specific conditions are conventional methods and conditions well known in the art, or according to the conditions recommended by the instrument manufacturer.

[0010] Example 1: A medicinal and edible health-preserving composition for enhancing immunity, comprising the following ingredients by weight: 40 parts ginseng, 35 parts Ganoderma lucidum, 35 parts Cistanche deserticola, 70 parts Polygonatum sibiricum, 45 parts Polygonatum odoratum, 55 parts Poria cocos, 90 parts Dioscorea opposita, 55 parts Euryale ferox, 55 parts Nelumbo nucifera, 200 parts soybean peptides, 15 parts Alpinia galanga, 8 parts cloves, and 8 parts nutmeg; The preparation method of the immune-enhancing food-derived health-preserving composition specifically includes the following steps: S101: Ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia officinarum are selected, washed, coarsely crushed to 5mm, dried with hot air at 60℃ until the moisture content is ≤8%, and set aside; cloves and nutmeg are selected, pulverized at low temperature at 20℃, and passed through a 60-mesh sieve, and set aside. S102: Mix the ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia galanga processed in step S101, add 9 times the amount of purified water, soak for 30 minutes, and perform two extractions: the first at 90℃ for 1.8 hours; the second at 95℃ for 1.2 hours; combine the extracts, pass through a 200-mesh sieve to obtain the aqueous extract; S103: Concentrate the aqueous extract from step S102 under reduced pressure to a relative density of 1.1; add anhydrous ethanol to bring the final ethanol concentration of the system to 70%, let it stand at 6°C for 12 hours, centrifuge at 6000 rpm for 15 minutes to collect the precipitate; reconstitute the precipitate with twice the mass of purified water. S104: The reconstituted solution from step S103 is concentrated under vacuum at 60°C to a relative density of 1.15, cooled to 45°C, and 40% of the total amount of soybean peptides is added under paddle stirring at 100 rpm. The mixture is stirred for 25 minutes until the system is homogeneous and free of obvious agglomeration, thus obtaining the peptide-extract composite soft material. S105: Add the remaining soybean peptides to the peptide-extract composite soft material from step S104, then add a mixture of 12wt% maltodextrin and pregelatinized starch at a mass ratio of 2:1; extrude and granulate with a sieve aperture of 1.2mm, boil dry at an inlet air temperature of 65℃ until the moisture content is ≤5%; after drying, cool to 30℃ and granulate through a 30-mesh sieve. S106: Add the dried granules from step S105 into a mixer and premix for 25 minutes. After the material temperature is ≤35℃, add the clove powder and nutmeg powder pretreated in step S101, and 1wt% silica. Continue mixing for 12 minutes. During the mixing process, control the material temperature to ≤35℃. Sterilize by irradiation with Co60 at a dose of 7kGy to obtain a medicinal and edible health care composition.

[0011] Example 2: A medicinal and edible health-preserving composition for enhancing immunity, comprising the following ingredients by weight: 45 parts ginseng, 40 parts Ganoderma lucidum, 45 parts Cistanche deserticola, 75 parts Polygonatum sibiricum, 50 parts Polygonatum odoratum, 50 parts Poria cocos, 80 parts Dioscorea opposita, 50 parts Euryale ferox, 50 parts Nelumbo nucifera, 220 parts soybean peptides, 12 parts Alpinia galanga, 6 parts cloves, and 6 parts nutmeg; The preparation method of the immune-enhancing food-derived health-preserving composition specifically includes the following steps: S101: Ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia officinarum are selected, washed, coarsely crushed to 5mm, dried with hot air at 60℃ until the moisture content is ≤8%, and set aside; cloves and nutmeg are selected, pulverized at low temperature at 20℃, and passed through a 60-mesh sieve, and set aside. S102: Mix the ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia galanga processed in step S101, add 10 times the amount of purified water, soak for 30 minutes, and perform two extractions: the first at 95℃ for 1.5 hours and the second at 100℃ for 1 hour; combine the extracts, pass through a 200-mesh sieve to obtain the aqueous extract; S103: Concentrate the aqueous extract from step S102 under reduced pressure to a relative density of 1.1; add anhydrous ethanol to bring the final ethanol concentration of the system to 60%; let stand at 4°C for 8 hours; centrifuge at 8000 rpm for 10 minutes to collect the precipitate; redissolve the precipitate with twice the mass of purified water. S104: The reconstituted solution from step S103 is concentrated under vacuum at 65°C to a relative density of 1.15, cooled to 45°C, and 60% of the total soybean peptides are added under paddle stirring at 120 rpm. The mixture is stirred for 30 minutes until the system is homogeneous and free of obvious agglomeration, thus obtaining the peptide-extract composite soft material. S105: Add the remaining soybean peptides to the peptide-extract composite soft material from step S104, and then add 15wt% maltodextrin; extrude and granulate with a sieve aperture of 0.8mm, boil dry with an inlet air temperature of 70℃ until the moisture content is ≤5%; after drying, cool to 30℃ and granulate through a 30-mesh sieve. S106: Add the dried granules from step S105 into a mixer and premix for 30 minutes. After the material temperature is ≤35℃, add the clove powder and nutmeg powder pretreated in step S101, as well as 2wt% silica. Continue mixing for 15 minutes, keeping the material temperature ≤35℃ throughout the mixing process. Sterilize by irradiation with Co60 at a dose of 8kGy to obtain a medicinal and edible health care composition.

[0012] Example 3: A medicinal and edible health-preserving composition for enhancing immunity, comprising the following ingredients by weight: 35 parts ginseng, 30 parts Ganoderma lucidum, 30 parts Cistanche deserticola, 65 parts Polygonatum sibiricum, 40 parts Polygonatum odoratum, 60 parts Poria cocos, 100 parts Dioscorea opposita, 60 parts Euryale ferox, 60 parts Nelumbo nucifera, 180 parts soybean peptides, 18 parts Alpinia officinarum, 12 parts cloves, and 12 parts nutmeg; The preparation method of the immune-enhancing food-derived health-preserving composition specifically includes the following steps: S101: Ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia officinarum are selected, washed, coarsely crushed to 5mm, dried with hot air at 60℃ until the moisture content is ≤8%, and set aside; cloves and nutmeg are selected, pulverized at low temperature at 20℃, and passed through a 60-mesh sieve, and set aside. S102: Mix the ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia galanga processed in step S101, add 8 times the amount of purified water, soak for 30 minutes, and perform two extractions: the first at 85℃ for 2 hours; the second at 90℃ for 1.5 hours; combine the extracts, pass through a 200-mesh sieve to obtain the aqueous extract; S103: Concentrate the aqueous extract from step S102 under reduced pressure to a relative density of 1.05; add anhydrous ethanol to bring the final ethanol concentration of the system to 80%; let stand at 10°C for 16 hours; centrifuge at 4000 rpm for 20 minutes to collect the precipitate; redissolve the precipitate with twice the mass of purified water. S104: The reconstituted solution from step S103 is concentrated under vacuum at 55°C to a relative density of 1.1, cooled to 45°C, and 30% of the total soybean peptides are added under paddle stirring at 60 rpm. The mixture is stirred for 15 minutes until the system is homogeneous and free of obvious agglomeration, thus obtaining the peptide-extract composite soft material. S105: Add the remaining soybean peptides to the peptide-extract composite soft material from step S104, then add 8wt% of a mixture of resistant dextrin and inulin at a mass ratio of 2:1; extrude granulation with a sieve aperture of 1.5mm, boil dry with an inlet air temperature of 60℃ until the moisture content is ≤5%; after drying, cool to 30℃ and granulate through a 30-mesh sieve. S106: Add the dried granules from step S105 into a mixer and premix for 15 minutes. After the material temperature is ≤35℃, add the clove powder and nutmeg powder pretreated in step S101, and 0.5wt% tricalcium phosphate. Continue mixing for 10 minutes. During the mixing process, control the material temperature to ≤35℃ throughout. Sterilize by irradiation with Co60 at a dose of 6kGy to obtain a medicinal and edible health care composition.

[0013] Comparative Example 1: The main difference between Comparative Example 1 and Example 1 is that the soybean peptides in Comparative Example 1 are added all at once in the total mixing stage of step S106; the remaining steps and parameters are the same as in Example 1.

[0014] Comparative Example 2: The main difference between Comparative Example 2 and Example 1 is that in Comparative Example 2, the amount of soybean peptides used in step S104 is reduced to 20% of the total amount; the remaining steps and parameters are the same as in Example 1.

[0015] Comparative Example 3: The main difference between Comparative Example 3 and Example 1 is that the number of ginseng parts is increased to 55 parts, the number of galangal parts is increased to 25 parts, and the number of yam parts is decreased to 65 parts; the remaining steps and parameters are the same as in Example 1.

[0016] Comparative Example 4: The main difference between Comparative Example 4 and Example 1 is that the strategy of adding cloves and nutmeg at the end of the process is omitted in Comparative Example 4. Instead, cloves and nutmeg are added together with the other medicinal and edible raw materials in the water extraction step for extraction. The remaining steps and parameters are consistent with those in Example 1.

[0017] Comparative Example 5: The main difference between Comparative Example 5 and Example 1 is that the number of Ganoderma lucidum parts in Comparative Example 5 is reduced to 15 parts and the number of yam parts is increased to 115 parts; the remaining steps and parameters are the same as in Example 1.

[0018] Uniformity and consistency testing: After thoroughly mixing the finished products of Example 1 and Comparative Examples 1-5 into a clean container, a layered sampling method of top-bottom-middle-corner was used. Four points were sampled from the top, middle, and bottom layers of the same batch of products, for a total of 12 sampling points. The sample weight at each sampling point was 2.0g. Before testing, each sample was pretreated in the same way: 40mL of purified water was added, and the mixture was extracted by shaking in a 50℃ water bath for 30min (shaking frequency 150rpm), and then cooled to... After reaching room temperature, the volume was adjusted to 50 mL, and the supernatant was collected after centrifugation at 5000 rpm for 10 min. The total polysaccharide content was used as the uniformity evaluation index. The absorbance was measured at 490 nm using the phenol-sulfuric acid method with glucose as the standard. The measurements were performed twice in parallel for each sampling point, and the average value was used to calculate the content. Then, the relative standard deviation (RSD) of the contents of the 12 sampling points was calculated. The samples were resampled independently, and 5 samples were randomly selected from each group. 3.0 g of each sample was weighed and added to a 250 mL beaker. 150 mL of purified water at 60℃ was added, and the mixture was stirred at 400 rpm for 2 min using a magnetic stirrer. The turbidity (NTU) of the suspension at 2 cm below the liquid surface was measured using a turbidimeter at 0, 10, and 30 min. The suspension was then transferred to a 250 mL stoppered graduated cylinder, and the sediment volume (mL) was recorded after standing for 30 min. The sedimentation layer height (mm) was also recorded. The test results are shown in Table 1 below.

[0019] Table 1. Results of homogeneity and reconstitution consistency tests of the health care compositions in the examples and comparative examples.

[0020] Based on the results in Table 1, Example 1 showed the most stable performance in terms of intra-batch uniformity of total polysaccharide content and consistency of reconstitution dispersion: it had the lowest RSD of total polysaccharides, and the turbidity decreased more slowly over time after reconstitution. The sedimentation volume and sedimentation layer height at 30 min were also at a low level, indicating that the active ingredient was more uniformly loaded in the particles and the suspension system was more stable after reconstitution. In contrast, Comparative Example 1 added all the soybean peptides at once during the total mixing stage, missing the key step of pre-dispersion and carrying on the peptide matrix of the extract, which led to a significant increase in the risk of uneven loading and microagglomeration, manifested as a significant increase in RSD, a rapid decrease in turbidity, and increased sedimentation. Although Comparative Example 2 retained the compounding step, the proportion of peptides involved in the compounding stage was relatively low, resulting in insufficient carrying and dispersing capacity. Therefore, its indicators were between those of Example 1 and Comparative Example 1, further confirming that there is a reasonable dosage window for soybean peptides in the compounding stage. Although Comparative Examples 3, 4, and 5 differed in their formulation or spice treatment, their structured granulation main chain remained intact, resulting in only slight fluctuations in uniformity. In Comparative Example 4, the removal of the final stage made it easier to introduce co-extracts, leading to slight flocculation and thus slightly affecting sedimentation and turbidity stability. Comparative Example 5, due to the increased proportion of yam, provided a certain level of basic bearing capacity and suspension stability, and therefore its reconstitution stability was close to that of Example 1.

[0021] Stability test of volatile oil: After thoroughly mixing the finished samples of Example 1 and Comparative Examples 1-5 in a clean container, a layered sampling method of top-bottom-middle-corner was used, taking 3 samples from each of the upper, middle, and lower layers, for a total of 9 sampling points; the sample weight at each sampling point was 2.0 g. Before determining the volatile oil content, each sample was pretreated in the same way: 2.0 g of sample was weighed and placed in a 250 mL Erlenmeyer flask, 50 mL of saturated sodium chloride solution was added, and then 10 mL of n-hexane was added as the extraction solvent. After sealing, the sample was extracted by shaking in a water bath at 25 °C for 30 min (shaking frequency 150 rpm). After standing and separating the layers, the organic phase was taken. If necessary, it was dehydrated with anhydrous sodium sulfate and filtered through a 0.22 μL filter. The sample was filtered through an organic filter membrane and used as the test solution. Gas chromatography-mass spectrometry (GC-MS) was used to determine the content of characteristic components of the volatile oil, with eugenol as the indicator component of clove volatile oil and myristole as the representative ether component in nutmeg volatile oil (GC-MS results are expressed as relative content (Example 1=100)). Each sampling point was injected twice in parallel, and the average value was used to calculate the relative content. The RSD (%) of the nine sampling points could be further calculated to characterize the uniformity of the volatile oil distribution in the finished product. Flavor stability was evaluated using a blinded sensory evaluation: five samples were randomly selected from each group, and 3.0 g of each sample was weighed and added to a 250 mL beaker, followed by the addition of 150 mL of... Purified water at 60℃ was stirred at 400 rpm for 2 minutes using a magnetic stirrer. After standing for 3 minutes, 20 subjects smelled and tasted the mixture, and rated the lasting fragrance and off-odor / deterioration (0 points was the worst and 5 points was the best). At the same time, the mixture was placed in an environment of 25℃ and stood for 30 minutes to evaluate the changes in lasting fragrance and off-odor again to characterize the flavor stability after mixing. The test results are shown in Table 2.

[0022] Table 2. Stability test results of volatile oils in the health care compositions of the examples and comparative examples.

[0023] Based on the results in Table 2, the relative contents of eugenol and myristole in Example 1 remained relatively high, and the lowest RSD was observed at 9 sampling points, indicating that the volatile oils were not only fully retained but also more uniformly distributed in the finished product. In the corresponding sensory evaluation, Example 1 exhibited higher aroma intensity and longer-lasting fragrance after 3 minutes of mixing, and maintained good fragrance retention and lower off-odor fluctuations even after standing for 30 minutes, demonstrating excellent flavor stability. In Comparative Example 4, after eliminating the final addition and treating cloves and nutmeg with water extraction, the relative contents of its volatile oil markers decreased significantly, the distribution RSD increased, and the fragrance faded faster and off-odor fluctuations were more pronounced after mixing. This indicates that high-temperature water extraction and subsequent concentration processes are more likely to cause volatile oil loss and flavor deterioration, further demonstrating the necessity of the final addition strategy for volatile oil retention and flavor stability. Comparative Examples 1 and 2 showed little decrease in the relative content of volatile oils, but their RSDs increased significantly, and the 30-minute fragrance retention decreased more noticeably. This indicates that when the peptide-extract composite is insufficient or absent, the poor particle microstructure and dispersion consistency indirectly amplify the uneven distribution of volatile oils and sensory fluctuations after mixing. This is consistent with the trend of faster turbidity decay and greater sedimentation shown in Table 1. Although the volatile oil content of Comparative Example 3 was close to that of Example 1, the shift in the intensity of warming and regulating the aroma resulted in a sharper and more irritating odor, manifested as a decrease in the off-odor / discomfort score and a decrease in fragrance retention stability. This indicates that the formulation window also has a balancing effect on the overall experience. Comparative Example 5, due to its better matrix carrying and dispersibility characteristics and a softer overall aroma, maintained a volatile oil distribution and fragrance retention close to that of Example 1.

[0024] Tolerance and overall experience testing: Forty healthy adult volunteers (male and female) were recruited, excluding pregnant and lactating women, those allergic to any ingredient in the formula, those who had experienced acute gastrointestinal discomfort within the past two weeks, or those currently taking medications affecting gastric acid secretion / gastrointestinal motility. Alcohol and spicy foods were avoided for 24 hours prior to the trial. A randomized, single-blind, crossover design was used: participants were randomly assigned to groups A and B. Group A took the sample from Example 1 on day 1 and the sample from Comparative Example 3 on day 2; Group B followed the reverse order. A washout period of at least 48 hours was allowed between the two trials to minimize residual effects. The administration method was standardized: participants took the sample 2 hours after breakfast, adding 3.0g of the sample to 150mL of purified water at 60℃, stirring with a disposable stirrer for 30 seconds, and drinking it within 5 minutes. No food was allowed for 30 minutes after drinking, except for a small amount of warm water. Participants completed a rating scale for stomach irritation / burning discomfort at 15, 30, and 60 minutes after drinking the product. The rating scale was 0-10 (0 indicating no discomfort, 10 indicating severe discomfort). They also recorded any accompanying symptoms such as acid reflux, belching, and nausea (these were only notes and not considered core indicators). To minimize subjective differences, staff explained the meaning and examples of the rating scale to participants before the trial, and participants were required to complete the scale independently while sitting quietly. If a participant experienced significant discomfort and requested termination, the trial was immediately stopped and recorded as a high-score event. The test results are shown in Table 3 below.

[0025] Table 3. Tolerance and Overall Experience Test Results of the Health Compositions in Examples and Comparative Examples

[0026] Based on the results in Table 3, Example 1 showed lower overall stomach irritation / burning discomfort scores at 15, 30, and 60 minutes after consumption, with a faster decrease over time and less individual fluctuation. In contrast, Comparative Example 3 showed higher discomfort scores at all three time points, exhibiting more significant individual differences and a higher tendency for peak discomfort, suggesting a wider range of tolerance and overall stomach irritation score fluctuations. Example 1, through the balanced combination of warming and tonifying qi-regulating and yin-nourishing and spleen-strengthening components, supplemented by spleen-strengthening ingredients such as yam, made its warming and tonifying effects more pronounced. The formula is relatively stable and less prone to short-term "dryness / irritation" sensations. However, in Comparative Example 3, the addition of ginseng and galangal while reducing the amount of yam resulted in a relatively higher intensity of warming and regulating qi, but a weaker buffering capacity, making it more likely to cause short-term discomfort such as heartburn and irritation after meals. Meanwhile, Comparative Example 3 still retains the structured process chain of "peptide-extract compound + granulation + temperature-controlled addition," and its discomfort score did not show extreme deterioration, indicating that some synergy still exists. However, when the ratio deviates from the optimal window, the overall tolerability and experience stability will still show a systematic decline.

[0027] Accelerated stability test: Samples from Examples 1-3 and Comparative Examples 1-5 were sealed in identical aluminum foil bags and placed at 40°C and 75% relative humidity for 14 days. The degree of agglomeration, odor generation, and color change were recorded visually and using a grading method. The degree of agglomeration was graded from 0 to 3 (0 for no agglomeration, 1 for slight clumping that can be easily dispersed by pressure, 2 for obvious hard lumps requiring crushing, and 3 for severe agglomeration that is difficult to disperse). 2.0g samples were taken, and the moisture content was determined using a rapid moisture analyzer (sampling times: 0 days, 7 days, and 14 days). The test results are shown in Table 4 and... Figure 1 As shown.

[0028] Table 4. Accelerated stability test results of the health care compositions in the examples and comparative examples

[0029] Based on Table 4 and Figure 1 As a result, Examples 1-3 showed a smaller increase in moisture content, lower caking grade, and better fluidity after 14 days of accelerated storage, with Example 1 being the most stable. Comparative Example 1, lacking the peptide-extract complex intervention point, had poor consistency between its internal particle structure and load, making it more prone to moisture absorption and irreversible caking under high temperature and humidity conditions. This manifested as a significant increase in moisture content, the highest caking grade, and a noticeable musty smell, which corroborates the unstable physical property trend of increased sedimentation and accelerated turbidity decay shown in Table 1. Comparative Example 2, while retaining the complexation step, had a lower proportion of peptides involved in the complexation stage, resulting in insufficient structural carrying capacity. Therefore, it exhibited moderate caking and decreased fluidity after moisture absorption, with stability between the Example group and Comparative Example 1. The main defects of Comparative Example 4 were in volatile oil retention and flavor stability (as shown in Table 2). Under accelerated conditions, this further manifested as aroma decay and a slight deterioration in odor. Simultaneously, due to the increased viscosity caused by the co-extract, its caking and fluidity also deteriorated to some extent. The shift in the warming and tonifying effect of Comparative Example 3 was primarily manifested in a decrease in odor stimulation and physical tolerance. Under accelerated conditions, it was characterized by fluctuations in the experience of "enhanced pungent and spicy sensation," accompanied by a certain tendency to clump. Comparative Example 5, due to the increased proportion of yam, exhibited a certain degree of matrix support and shaping stability. Its hygroscopicity and clumping degree were similar to those of the Example group, but its aroma was relatively weaker.

[0030] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A medicinal and edible health-promoting composition for enhancing immunity, characterized in that, Its composition includes the following ingredients by weight: 35-45 parts ginseng, 30-40 parts Ganoderma lucidum, 30-45 parts Cistanche deserticola, 65-75 parts Polygonatum sibiricum, 40-50 parts Polygonatum odoratum, 50-60 parts Poria cocos, 80-100 parts Dioscorea opposita, 50-60 parts Euryale ferox, 50-60 parts Nelumbo nucifera, 180-220 parts soybean peptides, 12-18 parts Alpinia galanga, 6-12 parts cloves and 6-12 parts nutmeg.

2. The immune-enhancing food-derived health-preserving composition according to claim 1, characterized in that, Its composition includes the following ingredients by weight: 45 parts ginseng, 40 parts Ganoderma lucidum, 45 parts Cistanche deserticola, 75 parts Polygonatum sibiricum, 50 parts Polygonatum odoratum, 50 parts Poria cocos, 80 parts Dioscorea opposita, 50 parts Euryale ferox, 50 parts Nelumbo nucifera, 220 parts soybean peptides, 12 parts Alpinia galanga, 6 parts cloves and 6 parts nutmeg.

3. The immune-enhancing food-medicine homology health-preserving composition according to claim 1, characterized in that, Its composition includes the following ingredients by weight: 40 parts ginseng, 35 parts Ganoderma lucidum, 35 parts Cistanche deserticola, 70 parts Polygonatum sibiricum, 45 parts Polygonatum odoratum, 55 parts Poria cocos, 90 parts Dioscorea opposita, 55 parts Euryale ferox, 55 parts Nelumbo nucifera, 200 parts soybean peptides, 15 parts Alpinia galanga, 8 parts cloves and 8 parts nutmeg.

4. The immune-enhancing food-medicine homology health-preserving composition according to claim 1, characterized in that, Its composition also includes food-grade excipients; said excipients are selected from one or more of fillers, flow aids, and forming agents.

5. A method for preparing a medicinal and edible health-promoting composition for enhancing immunity according to any one of claims 1-4, characterized in that, Specifically, the following steps are included: S101: Ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia officinarum are selected, washed, coarsely crushed, dried with hot air and set aside; cloves and nutmeg are selected, pulverized at low temperature, sieved and set aside. S102: Mix the ginseng, Ganoderma lucidum, Cistanche deserticola, Polygonatum sibiricum, Polygonatum odoratum, Poria cocos, Dioscorea opposita, Euryale ferox, lotus seeds and Alpinia galanga processed in step S101, add purified water, soak, extract twice, combine the extracts, screen, and obtain the aqueous extract. S103: Concentrate the aqueous extract from step S102 under reduced pressure; add anhydrous ethanol, let stand, centrifuge to collect the precipitate; redissolve the precipitate with purified water. S104: Vacuum concentrate the complex solution from step S103, cool it down, stir it, add 30-60% of the total amount of soybean peptides, and stir until the system is uniform and there is no obvious clumping to obtain peptide-extract composite soft material. S105: Add the remaining soybean peptides to the peptide-extract composite soft material from step S104, then add filler excipients, extrude and granulate, and boil dry; after drying, cool and granulate and screen. S106: Add the dried granules from step S105 into a mixer for premixing, then add the clove powder and nutmeg powder pretreated in step S101, as well as anti-caking excipients, and continue mixing. During the mixing process, control the material temperature throughout, and sterilize by irradiation to obtain a medicinal and edible health-care composition.

6. A method for preparing a medicinal and edible health-promoting composition for enhancing immunity according to claim 5, characterized in that, In step S102, the specific parameters for the two extractions are: the first extraction at 85-95℃ for 1.5-2 hours; and the second extraction at 90-100℃ for 1-1.5 hours.

7. A method for preparing a medicinal and edible health-promoting composition for enhancing immunity according to claim 5, characterized in that, In step S103, the centrifugation parameters are: 4000-8000 rpm, 10-20 min.

8. A method for preparing a medicinal and edible health-promoting composition for enhancing immunity according to claim 5, characterized in that, In step S105, the filler is one or more of maltodextrin, pregelatinized starch, microcrystalline cellulose, resistant dextrin, polydextrose, and inulin; the total amount of the filler is 8-15 wt%.

9. A method for preparing a medicinal and edible health-promoting composition for enhancing immunity according to claim 5, characterized in that, In step S106, the anti-caking additive is either silica or tricalcium phosphate; the total amount of the anti-caking additive added is 0.5 to 2 wt%.

10. A method for preparing a medicinal and edible health-promoting composition for enhancing immunity according to claim 5, characterized in that, In step S106, the parameters for irradiation sterilization are: Co60, dose 6-8 kGy.

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