A composition containing panax ginseng, galangal and astragalus, and a preparation method and application thereof

Abstract

This invention provides a composition containing American ginseng, galangal, and astragalus, along with its preparation method and application, belonging to the field of functional food technology. This invention uses three medicinal and edible extracts—American ginseng extract, astragalus extract, and galangal extract—as its core. Astragalus and American ginseng synergistically enhance immunity and replenish qi to combat fatigue, while galangal warms the stomach, dispels cold, and harmonizes the spleen and stomach. The three extracts achieve a balance of cold and heat, providing dual protection for immunity and the spleen and stomach. This effectively improves problems such as low immunity, stomach discomfort due to cold, and spleen and stomach weakness. Compared to single-ingredient formulas, this invention offers more comprehensive and targeted efficacy, is gentle and safe, and is suitable for long-term consumption.

Description

Technical Field

[0001] This invention belongs to the field of functional food technology, and in particular relates to a composition containing American ginseng, galangal and astragalus, its preparation method and application. Background Technology

[0002] With the development of modern lifestyles, people's dietary structure, work and rest patterns, and mental state have undergone certain changes. Regulating spleen and stomach function and enhancing immunity have become key health concerns. Spleen and stomach function is closely related to the body's immunity. Dysfunction of the spleen and stomach may affect nutrient absorption, thereby impacting immunity; conversely, insufficient immunity may indirectly affect the normal functioning of the spleen and stomach. The two are interconnected and mutually influential.

[0003] Currently, most functional products on the market targeting immune regulation or spleen and stomach conditioning are characterized by strong specificity but insufficient synergistic effects. Products focusing on immune regulation often rely on single herbal or Western medicine ingredients, lacking synergistic harmonization of spleen and stomach function, and long-term use may lead to discomfort. Products focusing on spleen and stomach conditioning (warming the stomach and dispelling cold) do not adequately address the enhancement of immunity, making it difficult to achieve synergistic improvement. Furthermore, some products have unscientific ingredient ratios and insufficient gentleness, making them suitable for long-term use. Therefore, developing a scientifically formulated, effective, gentle, and safe herbal composition suitable for long-term use can better meet the market's demand for synergistic improvement of spleen and stomach conditioning and immune regulation, and compensate for the shortcomings of existing technologies. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a composition containing American ginseng, galangal and astragalus, a preparation method and application thereof.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a composition containing American ginseng, galangal, and astragalus, comprising the following components in parts by weight: American ginseng extract 100-200 parts, astragalus extract 50-150 parts, galangal extract 200-300 parts.

[0006] Preferably, the components include the following parts by mass: American ginseng extract 120-180 parts, astragalus extract 80-120 parts, galangal extract 220-280 parts.

[0007] Preferably, the components include the following parts by mass: 150 parts of American ginseng extract, 100 parts of astragalus extract, and 250 parts of galangal extract.

[0008] Preferably, the total saponins in the American ginseng extract are ≥5.0%; The astragaloside A content of the astragalus extract is ≥0.1%.

[0009] The present invention provides the use of the composition in the preparation of foods that enhance immunity.

[0010] The present invention provides the use of the composition in the preparation of a medicine for warming the stomach and dispelling cold and / or enhancing immunity.

[0011] Preferably, the dosage form of the drug includes granules, oral liquid, or tablets.

[0012] Preferably, the method for preparing the granules includes the following steps: Mix the composition for 10-30 minutes, granulate, and sizing to obtain granules.

[0013] Preferably, the method for preparing the oral liquid includes the following steps: Mix the composition with water for 10-20 minutes, filter, fill, and sterilize to obtain the oral liquid.

[0014] Preferably, the method for preparing the tablet includes the following steps: Mix the composition with excipients for 10-30 minutes, then granulate, sizing, and compress to obtain tablets.

[0015] Compared with the prior art, the present invention has the following beneficial effects: This invention uses three medicinal and edible extracts—American ginseng extract, astragalus extract, and galangal extract—as its core. Astragalus and American ginseng synergistically enhance immunity and replenish qi to combat fatigue, while galangal warms the stomach, dispels cold, and harmonizes the spleen and stomach. The three extracts achieve a balance of warming and cooling properties, providing dual protection for both the immune system and the spleen and stomach. This effectively improves problems such as low immunity, stomach discomfort due to cold, and spleen and stomach weakness. Compared to single-ingredient formulas, this invention offers more comprehensive and targeted efficacy, is gentle and safe, and suitable for long-term consumption. The preparation process of this invention involves temperature control throughout to prevent the loss of effective ingredients. The steps are simple and easy to operate, and it can be prepared into various dosage forms such as granules, oral liquids, and tablets to suit different consumption scenarios. It is suitable for large-scale industrial production, reducing production costs. Detailed Implementation

[0016] This invention provides a composition containing American ginseng, galangal, and astragalus, comprising the following components in parts by weight: The extract contains 100-200 parts of American ginseng extract, preferably 120-180 parts, and more preferably 150 parts; the total saponins in the American ginseng extract are preferably ≥5.0%. The American ginseng extract replenishes qi and nourishes yin, strengthens the body's resistance, helps enhance the body's immunity, harmonizes the warming properties of astragalus, prevents internal heat, and at the same time replenishes the body with nutrients and relieves fatigue. The astragalus extract contains 50-150 parts, preferably 80-120 parts, and more preferably 100 parts. The astragaloside A content in the astragalus extract is preferably ≥0.1%. The astragalus extract replenishes qi and strengthens the exterior, enhances immunity, invigorates the spleen and benefits qi, provides energy to the body, improves the state of physical weakness and fatigue, and at the same time helps to regulate the spleen and stomach function and promote nutrient absorption. The extract contains 200-300 parts of galangal extract, preferably 220-280 parts, and even more preferably 250 parts. Galangal extract warms the stomach and dispels cold, harmonizes the spleen and stomach, and relieves discomfort such as stomach bloating, stomach pain, and loss of appetite caused by stomach cold. It also balances the cooling properties of American ginseng, achieving a balance between hot and cold, ensuring that the composition is mild and non-irritating, and suitable for long-term consumption.

[0017] The present invention provides the use of the composition in the preparation of foods that enhance immunity.

[0018] The present invention provides the use of the composition in the preparation of a medicine for warming the stomach and dispelling cold and / or enhancing immunity, wherein harmonizing the spleen and stomach includes warming the stomach and dispelling cold and enhancing immunity.

[0019] In this invention, the dosage form of the drug includes granules, oral liquids, or tablets.

[0020] In this invention, the method for preparing the granules preferably includes the following steps: mixing the composition, granulating, and sizing to obtain the granules; the mixing time is preferably 10-30 min, more preferably 15-25 min, and even more preferably 20 min; the mixing speed is preferably 10-30 rpm, more preferably 15-25 rpm, and even more preferably 20 rpm; the granulation method preferably includes dry roller pressing or wet granulation, wherein the temperature of wet granulation is preferably ≤45℃, the drying temperature is preferably ≤50℃, and the moisture content is preferably ≤5%; the particle size of the granulated particles is preferably 18-24 mesh, more preferably 19-22 mesh, and even more preferably 20 mesh.

[0021] In this invention, the preparation method of the oral liquid includes the following steps: mixing the composition with water, filtering, filling, and sterilizing to obtain the oral liquid. The mixing time is preferably 10-20 min, more preferably 12-18 min, and even more preferably 15 min; the mixing speed is preferably 10-30 rpm, more preferably 15-25 rpm, and even more preferably 20 rpm; the mixing temperature is preferably 20-40℃, more preferably 30-38℃, and even more preferably 35℃; the filter membrane is preferably 0.2-0.3 μm, more preferably 0.21-0.25 μm, and even more preferably 0.22 μm; the sterilization is preferably low-temperature sterilization, with a sterilization temperature preferably 40-50℃, more preferably 42-48℃, and even more preferably 45℃; the sterilization time is preferably 20-40 min, more preferably 25-35 min, and even more preferably 30 min; the filter membrane is preferably 0.2-0.3 μm, more preferably 0.21-0.25 μm, and even more preferably 0.22 μm.

[0022] In this invention, the tablet preparation method includes the following steps: mixing the composition with excipients, granulating, sizing, and compressing to obtain tablets. The mixing time is preferably 10-30 min, more preferably 15-25 min, and even more preferably 20 min; the mixing speed is preferably 10-30 rpm, more preferably 15-25 rpm, and even more preferably 20 rpm; the granulation method preferably includes wet granulation; wherein the wet granulation temperature is preferably ≤45℃, the drying temperature is preferably ≤50℃, and the moisture content is preferably dried to ≤5%; the particle size of the granulated particles is preferably 20-40 mesh, more preferably 25-35 mesh, and even more preferably 30 mesh.

[0023] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0024] Source of materials

[0025] Alpinia galanga extract (10:1), American ginseng extract (10:1, total saponins 5.5%) and Astragalus membranaceus extract (10:1, astragaloside A ≥0.1%) were purchased from Fufeng Sinote Biotechnology Co., Ltd. Clean-grade SD rats were purchased from Jinan Pengyue Experimental Animal Breeding Co., Ltd. The ELISA kit was purchased from Wuhan Merck Biotechnology Co., Ltd.

[0026] Example 1

[0027] Preparation of granules

[0028] Raw material preparation: 15kg American ginseng extract, 10kg Astragalus extract, 25kg Alpinia galanga extract, 240kg fructooligosaccharides, 50kg resistant dextrin, 6kg citric acid, and 4kg steviol glycosides; all raw materials meet food-grade standards and have passed third-party testing.

[0029] Pretreatment: Pass all raw materials through a 100-mesh sieve to remove impurities and ensure that the raw materials are fine and uniform; store the three extracts in a cool, dry environment away from light at 22℃ and 50%RH.

[0030] Mixing: Take American ginseng extract, astragalus extract, and galangal extract, and mix them at 20 rpm for 12 min using the equal-increment method. Then add fructooligosaccharides, resistant dextrin, citric acid, and steviol glycosides, and mix for a total of 20 min to ensure a mixing uniformity of ≥98%.

[0031] Granulation: Dry roller pressing granulation process is used to produce 20 mesh granules, which are dried to a moisture content of ≤5%, and lumps and fine powder are removed after granulation.

[0032] Packaging: The product is packaged in aluminum foil bags at 10g / bag specifications and sealed to obtain the finished granules. The finished product should be stored in a cool and dry environment and has a shelf life of 18 months.

[0033] Example 2

[0034] Raw material preparation: 20kg American ginseng extract, 15kg Astragalus extract, 30kg Alpinia galanga extract, 240kg fructooligosaccharides, 50kg resistant dextrin, 6kg citric acid, 4kg steviol glycosides, and 2700kg purified water; all raw materials meet food-grade standards and have passed third-party testing.

[0035] Pretreatment: Crush all excipients to a fineness of 100 mesh or higher, pass the three extracts through a 100-mesh sieve, and store in a cool, dry environment away from light.

[0036] Dissolution: Take purified water, control the temperature at 35℃, add fructooligosaccharides, resistant dextrin, citric acid, and steviol glycosides, stir at 20 rpm for 15 minutes until completely dissolved, and obtain the excipient solution.

[0037] Mixing: Add American ginseng extract, astragalus extract and galangal extract to the excipient solution, stir at 20 rpm for 18 minutes to ensure complete dissolution, and obtain the herbal solution.

[0038] Filtration: The mixed solution was filtered through a 0.22 μm filter membrane to obtain a clear solution.

[0039] Filling and sterilization: Fill in 30ml / vial and sterilize at 45℃ for 30 minutes to avoid loss of active ingredients.

[0040] Packaging: After filling, seal, label, and box to obtain the finished oral liquid product; store the finished product in a low-temperature, light-proof environment at 2~8℃, with a shelf life of 18 months.

[0041] Example 3

[0042] Raw material preparation: 10kg American ginseng extract, 5kg Astragalus extract, 20kg Alpinia galanga extract, 10kg starch, 0.5kg magnesium stearate; all raw materials meet food-grade standards and have passed third-party testing.

[0043] Pre-treatment: Pass all raw materials through a 100-mesh sieve to remove impurities and ensure that the raw materials are fine and uniform.

[0044] Mixing: Take American ginseng extract, astragalus extract, galangal extract and starch, mix at 20 rpm for 18 min using the equal-increment method, add magnesium stearate and continue mixing for 5 min to ensure the mixing uniformity is ≥98%.

[0045] Granulation: Add an appropriate amount of purified water as a binder and granulate by wet granulation (temperature 40℃) to obtain 30-mesh granules, and dry to a moisture content of ≤5%.

[0046] Granulation and tableting: After granulation, tablets are compressed using a tableting machine, with the tablet weight controlled at 0.8g / tablet and the tablet weight difference ≤±5%.

[0047] Packaging: Packaged in aluminum foil blister packs, 12 pieces per blister pack, sealed, and stored in a cool, dry environment. Shelf life is 18 months.

[0048] Comparative Example 1

[0049] Compared to Example 1, this example lacks Alpinia galanga extract, but is otherwise identical to Example 1.

[0050] Comparative Example 2

[0051] Compared to Example 1, this example lacks American ginseng extract, but is otherwise identical to Example 1.

[0052] Experimental Example 1

[0053] Eighty-four clean-grade SD rats, 7-8 weeks old, weighing 180-200g, with half males and half females, were selected and housed in an indoor environment maintained at 23-25℃ and 50-60% relative humidity, exposed to daylight lamps with alternating light and dark periods of 12 hours each. They had free access to food and water and underwent one week of acclimatization. The 84 rats were then randomly divided into 7 groups of 12 rats each: control group, model group, control group 1, control group 2, low-dose group, medium-dose group, and high-dose group. Except for the control group, the other 6 groups were used to establish a rat model of chronic gastritis.

[0054] Methods for establishing a rat model of chronic gastritis: 55-degree baijiu (Chinese liquor) was used as drinking water for rats to establish the model. After three consecutive weeks of modeling, one male and one female rat were randomly selected for necropsy and observation of the gastric mucosa compared with that of normal animals. The presence of congestion, edema, defects, and bleeding points in the model animals was observed to determine whether the model had been established.

[0055] The rats exhibited decreased appetite, emaciation, dull fur, and grayish-white, dull gastric mucosa with poor extensibility, little surface mucus, and scattered petechiae. In contrast, the gastric mucosa of normal animals was smooth, pink, covered with a thick layer of mucus, and showed good elasticity. This indicated that the rat model of chronic gastritis had been established, and the appropriate treatment was initiated.

[0056] Control group: 4.0 ml / kg of purified water was administered by gavage once a day; Model group: 4.0 ml / kg of purified water was administered by gavage once a day; Control group 1: The granules of Comparative Example 1 were prepared into a solution with a concentration of 0.5 g / ml, and the gavage volume was 4.0 ml / kg, once a day; Control group 2: The granules of control group 2 were prepared into a solution with a concentration of 0.5 g / ml, and the gavage volume was 4.0 ml / kg, once a day; Low-dose group: The granules of Example 1 were prepared into a solution with a concentration of 0.25 g / ml, and the gavage volume was 4.0 ml / kg, once a day; Medium-dose group: The granules of Example 1 were prepared into a solution with a concentration of 0.5 g / ml, and the gavage volume was 4.0 ml / kg, once a day; High-dose group: The granules of Example 1 were prepared into a solution with a concentration of 1.0 g / ml, and the gavage volume was 4.0 ml / kg, once a day; Testing indicators: General observation: Daily records were made of the rats' mental state, hair, and fecal characteristics. The results showed that the control group rats were active, had smooth hair, normal appetite, and formed stools; the model group rats were lethargic, had dry and fluffy hair, reduced food intake, and loose stools; the control group 1 / 2 showed slight improvement in mental state and appetite, but still had loose stools and dry hair; the low / medium / high dose groups of this invention showed improved mental state, gradually smoother hair, and formed stools, and were better than the control group 1 / 2.

[0057] Gastric Mucosal Injury Index (GI): After sacrificing rats, the stomach was removed, cut open along the greater curvature, rinsed with physiological saline, and scored according to the degree of gastric mucosal congestion, erosion, and ulceration. The injury index was then calculated. Gastric mucosal damage index (GI): After administration, rats were fasted for 12 hours but allowed free access to water. They were then anesthetized and euthanized. The stomach was cut along the greater curvature, and the gastric contents were rinsed with physiological saline. The damage index was calculated based on the degree of gastric mucosal congestion, erosion, and ulceration. The scoring criteria are shown in Table 1. Table 1. Gastric Mucosal Injury Index (GI) Scoring Criteria

[0058] GI value = congestion score + edema score + bleeding point score + erosion score + ulcer / mucosal defect score.

[0059] Damage severity grading: 0 points (normal), 1-4 points (mild damage), 5-8 points (moderate damage), 9-15 points (severe damage).

[0060] The results are shown in Table 2: Table 2 Gastric Mucosal Injury Index

[0061] The results showed that the glycemic index (GI) of each treatment group was significantly lower than that of the model group (P<0.01); the GI of the medium and high dose groups in this invention was significantly lower than that of the control group 1 / 2 (P<0.05), indicating that the gastric mucosa protection effect of the three-ingredient combination was better than that of the single-component deficiency group.

[0062] Serum inflammatory factors: Blood was collected from the abdominal aorta, serum was separated, and the levels of TNF-α, IL-6, and IL-1β were detected by ELISA; the results are detailed in Table 3. Table 3. Levels of TNF-α, IL-6, and IL-1β in different groups of rats

[0063] Note: Compared with the model group, P<0.05, P<0.01; compared with control group 1 / 2, #P<0.05.

[0064] The results showed that the serum levels of TNF-α, IL-6, and IL-1β in the model group were significantly higher than those in the blank group (P<0.01), indicating that the gastric inflammatory response was severe after modeling. The levels of inflammatory factors in each treatment group decreased, and the reduction effect in the medium and high dose groups of this invention was extremely significant (P<0.01), and significantly better than half of the control group (#P<0.05), indicating that the composition can effectively inhibit the gastric inflammatory response.

[0065] Immune organ index: The thymus and spleen were separated and weighed, and the immune organ index was calculated as organ weight (mg) / body weight (g). The results are shown in Table 4. Table 4 Immune Organ Index

[0066] Note: Compared with the model group, P<0.05, P<0.01; compared with control group 1 / 2, #P<0.05.

[0067] The results showed that the thymus index and spleen index of the model group rats were significantly lower than those of the blank group (P<0.01), indicating that immune organs were atrophied and immune function was impaired. The immune organ index of each dose group of the present invention was significantly improved, and the medium and high dose groups were extremely effective (P<0.01), and significantly higher than the control group (#P<0.05), indicating that the composition can effectively improve immune organ atrophy and enhance the body's immune function.

[0068] Serum immunoglobulins: Serum IgG and IgA levels were detected by ELISA, and the results are shown in Table 5. Table 5 Serum Immunoglobulin Levels

[0069] Note: Compared with the model group, P<0.05, P<0.01; compared with Comparative Example 1 and Comparative Example 2, #P<0.05.

[0070] The results showed that the serum IgG and IgA levels in the model group rats were significantly lower than those in the blank group (P<0.01), indicating a decline in humoral immune function. The IgG and IgA levels in the medium and high dose groups of this invention were significantly increased (P<0.01), which was significantly better than that in the comparative group (#P<0.05), indicating that the composition can effectively enhance humoral immune function.

[0071] Experiment Example 2

[0072] Efficacy verification experiment

[0073] 120 sub-healthy volunteers, aged 25-55, 60 men and 60 women, were selected. All of them had problems such as low immunity (easy to catch colds and fatigue), stomach discomfort (stomach bloating and stomach pain after being exposed to cold), and weak spleen and stomach. Pregnant women, breastfeeding women, infants, people with allergies, and people with serious diseases were excluded.

[0074] Experimental group: Take one sachet (10g) of the granules prepared in Example 1 of this invention daily, dissolved in warm water, for 30 consecutive days.

[0075] Control group 1: Take one sachet (10g) of the granules prepared in control group 1 daily for 30 consecutive days.

[0076] Control group 2: Take one sachet (10g) of the granules prepared in control group 2 daily for 30 consecutive days.

[0077] Control group: No functional products were used; normal diet was maintained for 30 consecutive days.

[0078] After the experiment, the improvement in immunity (less fatigue, less susceptibility to colds) and the relief of stomach discomfort (reduction in bloating and stomach pain) of each group of volunteers were statistically analyzed. The improvement rate was calculated as follows: Immunity improvement rate: effective was defined as less fatigue, reduced frequency of colds, and improved mental state; the percentage of effective participants was calculated. Stomach discomfort relief rate: effective was defined as reduced bloating / stomach pain, no discomfort after exposure to cold, and improved appetite; the percentage of effective participants was calculated. 6.3 Improvement rate (%) = (Number of effective participants / Total number of participants in the group) × 100%. The results are shown in Table 6.

[0079] Table 6. Improvement in immunity among volunteers in each group.

[0080] The experimental group showed significantly better results than control group 1, control group 2 and blank group in terms of improving immunity and relieving stomach cold discomfort. This proves that the American ginseng extract, astragalus extract and galangal extract in the formula of this invention have a significant synergistic effect. None of them can be omitted. They can effectively achieve the core effects of enhancing immunity and warming the stomach and dispelling cold. Moreover, the product is mild and non-irritating and suitable for long-term consumption.

[0081] Experimental Example 3

[0082] Stability test

[0083] The products prepared in Example 1 (granules), Example 2 (oral liquid), and Example 3 (tablets) were stored under corresponding storage conditions for 18 months. Key indicators of the products were tested at 0 months, 6 months, 12 months, and 18 months to verify product stability. The results are shown in Table 7. Table 7 Stability test results

[0084] Experiments have shown that the granules, oral liquids, and tablets prepared from the composition of this invention exhibit minimal changes in the content of total ginsenosides and astragaloside A within their respective shelf lives, with no changes in their state or taste. They demonstrate excellent stability in industrial production and can meet market circulation demands.

[0085] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A composition containing American ginseng, galangal, and astragalus, characterized in that, The components include the following parts by mass: American ginseng extract 100-200 parts, astragalus extract 50-150 parts, galangal extract 200-300 parts.

2. The composition according to claim 1, characterized in that, The components include the following parts by mass: American ginseng extract 120-180 parts, astragalus extract 80-120 parts, galangal extract 220-280 parts.

3. The composition according to claim 2, characterized in that, The components include the following parts by mass: 150 parts of American ginseng extract, 100 parts of astragalus extract, and 250 parts of galangal extract.

4. The composition according to any one of claims 1 to 3, characterized in that, The total saponins in the American ginseng extract are ≥5.0%; The astragaloside A content of the astragalus extract is ≥0.1%.

5. The use of the composition according to any one of claims 1 to 4 in the preparation of food with enhanced immunity.

6. The use of the composition according to any one of claims 1 to 4 in the preparation of a medicament for warming the stomach and dispelling cold and / or enhancing immunity.

7. The application according to claim 6, characterized in that, The dosage forms of the drug include granules, oral liquids, or tablets.

8. The application according to claim 7, characterized in that, The method for preparing the granules includes the following steps: Mix the composition for 10-30 minutes, granulate, and sizing to obtain granules.

9. The application according to claim 7, characterized in that, The preparation method of the oral liquid includes the following steps: Mix the composition with water for 10-20 minutes, filter, fill, and sterilize to obtain the oral liquid.

10. The application according to claim 7, characterized in that, The method for preparing the tablet includes the following steps: Mix the composition with excipients for 10-30 minutes, then granulate, sizing, and compress to obtain tablets.

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