A medicine-food homologous composition capable of improving immune function and its preparation method and application

Abstract

The present invention discloses a medicine-food combination for improving immune function, and a preparation method and application thereof. The formula of the medicine-food combination for improving immunity comprises medicine-food raw materials such as gastrodia elata extract, ginseng extract, American ginseng extract, codonopsis pilosula extract, astragalus extract, ophiopogon extract, etc. The formula is designed in accordance with the theory of Chinese medicine compatibility, so that the combination can play a synergistic role and significantly improve the immune ability. In addition, the composition components of the present invention are all derived from medicine-food raw materials, the components are natural, the use is safe and effective, and the market application prospects are broad.

Description

Technical Field

[0001] The invention relates to a medicine-food homologous composition capable of improving immune function, a preparation method and application thereof, and belongs to the field of medicines, foods or health foods. Background Art

[0002] Modern medical research has found that more than 90% of human diseases are related to immune system disorders. When the immune system is normal, it can recognize all exogenous antigens and respond, and produce immune tolerance to its own cells and molecules. The immune system assumes the body's immune function. If a part of the immune system is defective, it may lead to a decrease in the individual's ability to resist the invasion of pathogens. Improving immunity is very important for our health. The immune system is our body's defense system that helps us fight diseases and infections. A strong immune system can help us fight viruses, bacteria and other pathogens more easily, thereby reducing the chance of getting sick. In addition, immunity can also help us recover faster and reduce the impact of diseases on us. Improving immunity can also help us better cope with stress and environmental changes, and keep us healthy and energetic.

[0003] With the progress of society and fierce competition, the number of people with low immunity is increasing day by day, so people's demand for products that improve immunity is increasing day by day. Products that enhance immunity are no longer satisfied with biochemical products, but more favor natural plants and Chinese medicine extracts.

[0004] Traditional Chinese medicine, especially herbal medicine, is gaining more and more attention from countries around the world because of its safety and effectiveness. It is a valuable resource for the development of products with medicinal and edible effects. At present, there are more than 12,000 varieties of traditional Chinese medicine on the market, including more than 11,000 herbal medicines, more than 1,500 animal medicines, and more than 80 mineral medicines. Based on the rich resources of traditional Chinese medicine left over from the history of more than 2,000 years of Chinese medicine, by analyzing and extracting the effective ingredients, and then optimizing and improving them through compatibility, safer and more effective drugs, foods and health products are developed. At the same time, based on a large amount of existing clinical data of traditional Chinese medicine, through analysis and mining, the clinical treatment clues are found, so as to develop new drugs, health products or therapies.

[0005] The material basis for the efficacy of Chinese medicine is various chemical components, and various chemical components produce complex physical and chemical reactions under the combination of prescriptions, thus affecting the final efficacy. Mastering the compatibility of Chinese medicine is of great significance for accurately guiding Chinese medicine to exert its expected efficacy and improving clinical efficacy. Chinese medicine compatibility is guided by the basic theory of traditional Chinese medicine, based on the theory of Chinese medicine properties and the theory of Chinese medicine differentiation and treatment, and selectively applies Chinese medicine that matches its nature, taste and function for diseases, syndromes or symptoms, in order to achieve the purpose of enhancing efficacy, improving efficacy and reducing toxic side effects through combination.

[0006] At present, there are many products related to improving immune function, but the existing products have more or less problems such as the raw materials are produced in many places, the types are complicated, the quality is uneven, and it is difficult for ordinary consumers to choose and identify; the processing has a great impact on the medicinal properties of the products, the overall absorption effect is poor, and it is not convenient to eat and affects absorption. The existing processing technology is rough and cannot effectively release a variety of nutrients, let alone the ability to complement and strengthen nutrition. Moreover, some nutritional products are only suitable for specific groups of people; the formula products do not consider the compatibility relationship between drugs, which is not conducive to the treatment of diseases. In addition, these products that enhance immune function have different tastes, and the proportioning method lacks the guidance of traditional Chinese medicine theory, and they cannot play the role of food therapy.

[0007] In view of this, developing an immune-enhancing product based on the wisdom of Chinese medicine, which is safe, non-toxic, pleasant in taste, and suitable for long-term use, is not only an exploration of the integration of traditional medicine and modern technology, but also a major contribution to improving public health and promoting social welfare. Its economic value and social significance are self-evident. Summary of the invention

[0008] The present invention provides a medicine-food combination for enhancing immune function and a preparation method and application thereof, wherein the combination comprises ingredients such as gastrodia elata extract, ginseng extract, American ginseng extract, codonopsis pilosula extract, astragalus extract, ophiopogon japonicus extract, and the function of the medicine-food combination for enhancing immunity is evaluated by animal experiments. The purpose of the invention is to solve the problems of low absorption efficiency, poor medicinal properties, poor safety, and difficult quality control of current products for improving immunity, and to provide a medicine-food combination product that can effectively improve immune function and is safe for human body.

[0009] In order to achieve the above-mentioned purpose, the present invention adopts the following technical solutions:

[0010] The invention provides a medicine-food composition with the function of improving immunity, which comprises gastrodia elata extract, ginseng extract, American ginseng extract, codonopsis pilosula extract, astragalus extract and ophiopogon extract.

[0011] Preferably, in the edible-medicinal composition, by mass percentage, the content of Gastrodia elata extract is not higher than 30%, the content of Panax ginseng extract is not higher than 25%, the content of American ginseng extract is not higher than 25%, the content of Codonopsis pilosula extract is not higher than 25%, the content of Astragalus membranaceus extract is not higher than 25%, and the content of Ophiopogon japonicus extract is not higher than 25%.

[0012] Preferably, the edible-medicine composition comprises, by mass percentage, 5%-30% of Gastrodia elata extract, 5%-25% of Ginseng extract, 5%-25% of American ginseng extract, 5%-25% of Codonopsis pilosula extract, 5%-25% of Astragalus extract, and 5%-25% of Ophiopogon japonicus extract. The edible-medicine composition is designed in accordance with the theory of Chinese medicine compatibility, has a reasonable formula, and can significantly improve immune function by exerting a synergistic effect.

[0013] Preferably, the edible and medicinal composition comprises, by mass percentage, 10%-25% of Gastrodia elata extract, 10%-20% of Ginseng extract, 10%-20% of American ginseng extract, 10%-20% of Codonopsis pilosula extract, 10%-20% of Astragalus extract, and 10%-20% of Ophiopogon japonicus extract.

[0014] More preferably, the edible and medicinal composition comprises, by mass percentage, 20% of Gastrodia elata extract, 13% of Ginseng extract, 12% of American ginseng extract, 14% of Codonopsis pilosula extract, 16% of Astragalus membranaceus extract, and 15% of Ophiopogon japonicus extract; or 15% of Gastrodia elata extract, 15% of Ginseng extract, 10% of American ginseng extract, 19% of Codonopsis pilosula extract, 16% of Astragalus membranaceus extract, and 14% of Ophiopogon japonicus extract; or 10% of Gastrodia elata extract, 19% of Ginseng extract, 14% of American ginseng extract, 11% of Codonopsis pilosula extract, 17% of Astragalus membranaceus extract, and 13% of Ophiopogon japonicus extract.

[0015] In some embodiments of the present invention, the extract is a solid powder obtained by taking the pharmacopoeial part of each medicinal material, crushing it, extracting it, separating it, and purifying it.

[0016] Preferably, the pharmacopoeial part of each medicinal material is extracted by water extraction, which avoids the loss of its active ingredients by other extraction methods such as solvent extraction, avoids the introduction of exogenous impurities, and can also concentrate the active ingredients.

[0017] The properties, flavors, meridians and effects of the drugs in the composition of the present invention are as follows:

[0018] Gastrodia elata: sweet, neutral, belongs to the liver meridian. It is good at calming wind and stopping spasms, calming liver yang, and treating liver yang and liver wind symptoms, regardless of cold, heat, deficiency or excess. It can dispel wind and dredge meridians, and treat arthralgia, limb numbness, and limb paralysis. Chemical composition studies have shown that Gastrodia elata contains phenols and their glycosides including gastrodin, p-hydroxybenzyl alcohol, vanillin, benzyl alcohol, etc.; polysaccharide organic acids and their esters, steroids and their glycosides, etc. Its main characteristic component is gastrodin. Modern pharmacological studies have shown that Gastrodia elata gastrodin and its metabolites can quickly pass through the blood-brain barrier, and have significant effects of helping sleep, anti-depression, anti-anxiety and improving learning ability. Gastrodia elata polysaccharides have the effect of enhancing the body's nonspecific immunity and cellular immunity.

[0019] Ginseng: sweet, slightly bitter, slightly warm, and enters the spleen, lung, heart, and kidney meridians. It is good at replenishing vital energy and treating qi deficiency and collapse; it is also good at replenishing the qi of the spleen and lungs to treat various symptoms of spleen and lung qi deficiency; it can also replenish qi and produce body fluid, calm the mind, and improve intelligence, and treat thirst, thirst, restlessness, palpitations, and forgetfulness caused by body fluid loss. Ginseng rhizomes contain a variety of saponins and polysaccharides, the main characteristic components of which are ginsenoside Re, ginsenoside Rg1, and ginsenoside Rb1. In addition, it also contains amino acids, volatile oils, vitamins, and trace elements. Among them, ginsenosides, polysaccharides, oligopeptides and other effective ingredients have a significant improvement effect on sports fatigue, postoperative fatigue, and chronic fatigue syndrome. Ginsenosides and ginseng polysaccharides can exert anti-tumor, anti-inflammatory, and anti-aging effects by regulating immune cells and cytokines in immune organs.

[0020] American ginseng: sweet, slightly bitter, cool, and enters the heart, lung, and kidney meridians. It is good at replenishing qi and nourishing yin, and is good at clearing heat and promoting body fluid. It is mainly used to treat qi and yin deficiency or yin deficiency and body fluid damage, especially for those with heat. The "Chinese Pharmacopoeia" stipulates that the total amount of ginsenoside Rg1, ginsenoside Re, and ginsenoside Rb1 in American ginseng must not be less than 2.0%. In addition, it also contains polyacetylenes, flavonoids, lignans, organic acids, polysaccharides, sterols, volatile oils, peptides, amino acids, and proteins. American ginseng promotes serum protein synthesis and improves the body's immunity. As a traditional Chinese medicine for replenishing qi, American ginseng can replenish the body's material losses, enhance human functions, and thus improve disease resistance.

[0021] Codonopsis: sweet, neutral. Enters the spleen and lung meridians. It is mostly used for mild symptoms of spleen and lung qi deficiency. It also produces body fluid and nourishes blood, and can treat body fluid deficiency and blood deficiency. The root of Codonopsis contains sterols, alkaloids, triterpenes and volatile components. In addition, it also contains a variety of trace elements, amino acids, volatile oils, etc. Modern pharmacological studies have shown that Codonopsis also has a variety of pharmacological effects such as enhancing the body's immunity, protecting the gastrointestinal mucosa and resisting ulcers, promoting hematopoiesis, regulating blood sugar, and delaying aging; at the same time, Codonopsis is also a health product and can be included in the diet.

[0022] Astragalus: sweet, slightly warm, enters the spleen and lung meridians. It is good at replenishing the middle qi, raising the clear yang, replenishing the lung qi, benefiting the stomach and strengthening the exterior, treating spleen and lung qi deficiency, sinking of the middle qi, qi failure to absorb blood, spontaneous sweating and night sweats, etc. It can also support sores, promote diuresis and reduce swelling, treat sores caused by insufficient qi and blood that are not clear or long-term clearing, as well as qi deficiency edema and urination difficulties. The chemical composition is complex, containing polysaccharides, various saponins, flavonoids, amino acids, linoleic acid, alkaloids, etc. Astragalus extract is a product extracted from the dried roots of Astragalus, and its main characteristic component is astragalus polysaccharides (APs).

[0023] Ophiopogon japonicus: sweet, slightly bitter, slightly cold. It enters the heart, lung, and stomach meridians. It nourishes yin and produces body fluids, moistens the lungs and benefits the stomach, clears the mind and relieves restlessness and calms the nerves, and moistens the intestines and relieves constipation. It treats lung and stomach yin deficiency, restlessness and insomnia, and constipation caused by dry intestines. The Chinese Pharmacopoeia stipulates that this product, calculated on a dry basis, contains Ophiopogon japonicus total saponins in the form of ruscosaponin (C 27 H 42 O4), not less than 0.12%. In addition, it also contains steroidal saponins, high isoflavones, polysaccharides, volatile oils and trace elements. The two major substances of polysaccharides and flavonoids in the biologically active components of Ophiopogon japonicus have shown a very good effect in promoting cellular immune function in both clinical and laboratory studies, which can enhance the activity of phagocytes and further resist the invasion of foreign viruses.

[0024] Wherein, the preparation method of the Gastrodia elata extract is:

[0025] Preparation of Gastrodia elata extract: Gastrodia elata tubers are taken, crushed, extracted with water, filtered, the residue is squeezed, the filtrate is combined, concentrated, dried, crushed and sieved to obtain Gastrodia elata extract.

[0026] Wherein, the preparation method of the ginseng extract is:

[0027] Preparation of ginseng extract: Take the root or rhizome of ginseng, crush it, add water to extract, filter it, squeeze the residue, combine the filtrate, concentrate it, dry it, crush it and sieve it to obtain the ginseng extract.

[0028] The preparation method of the American ginseng extract is as follows: Preparation of the American ginseng extract: taking the root of American ginseng, crushing it, adding water to extract, filtering, squeezing the residue, combining the filtrate, concentrating, drying, crushing and sieving to obtain the American ginseng extract.

[0029] Wherein, the preparation method of the Codonopsis pilosula extract is:

[0030] Preparation of Codonopsis pilosula extract: Take the root of Codonopsis pilosula, crush it, add water to extract, filter it, squeeze the residue, combine the filtrate, concentrate it, dry it, crush it and sieve it to obtain the Codonopsis pilosula extract.

[0031] Wherein, the preparation method of the astragalus extract is:

[0032] Preparation of Astragalus extract: Take the root of Astragalus, crush it, add water to extract, filter, squeeze the residue, combine the filtrate, concentrate, dry, crush and sieve to obtain the Astragalus extract.

[0033] Wherein, the preparation method of the Ophiopogon japonicus extract is:

[0034] Preparation of Ophiopogon japonicus extract: Take the tuberous root of Ophiopogon japonicus, crush it, add water to extract, filter it, squeeze the residue, combine the filtrate, concentrate it, dry it, crush it and sieve it to obtain the Ophiopogon japonicus extract.

[0035] In some embodiments of the present invention, the medicine-food composition further comprises a sweetener.

[0036] In some preferred embodiments of the present invention, the mass percentage of the sweetener is 1-20%, more preferably 1-10%.

[0037] In some preferred embodiments of the present invention, the sweetener includes but is not limited to honey, sorbitol, maltitol, isomalt (also known as isomalt, palatinol), xylitol, lactitol, mannitol, erythritol, isomalt-oligosaccharide, stevioside, licorice, disodium glycyrrhizinate, tripotassium glycyrrhizinate, and trisodium glycyrrhizinate.

[0038] In some embodiments of the present invention, the medicine-food composition further includes a pharmaceutically acceptable excipient.

[0039] Preferably, the auxiliary materials include at least one of fillers, lubricants, dispersants, wetting agents, binders, disintegrants, antioxidants and preservatives.

[0040] The fillers include, but are not limited to, maltodextrin, fructooligosaccharides, galacto-oligosaccharides, resistant dextrin, inulin, mannitol, and cellulose.

[0041] The lubricant includes but is not limited to micro powder silica gel, silicon dioxide, magnesium stearate, and sodium stearyl fumarate.

[0042] The wetting agent generally includes purified water or ethanol solutions in different proportions.

[0043] The disintegrant generally includes sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone and the like.

[0044] In some embodiments of the present invention, the medicine-food composition can be prepared into any one of decoction, tablet, powder, powder, pill, granule, oral liquid, capsule or paste dosage form. The above dosage forms can be prepared by conventional processes in the art and will not be described in detail here.

[0045] The invention provides use of the composition in preparing products for improving immunity.

[0046] The products described in the present invention include medicines, foods and health products.

[0047] Beneficial effects:

[0048] The medicine-food combination provided by the present invention combines the immune concept of traditional Chinese medicine, is based on the holistic concept of traditional Chinese medicine, and combines the functional ingredients in modern medicine that can enhance immune molecules and cytokines, thereby achieving significant improvement in immunity and effectively enhancing immune function.

[0049] The medicinal and edible composition according to the embodiment of the present invention has at least the following beneficial effects: the medicinal and edible composition provided by the present invention, the formula contains medicinal and edible raw materials such as Gastrodia elata extract, ginseng extract, American ginseng extract, Codonopsis pilosula extract, Astragalus extract, Ophiopogon japonicus extract, etc., and the formula naturally carries the known functions of the above-mentioned Chinese medicines themselves, and the effect can be expected. The present invention follows the theory of Chinese medicine compatibility to design the formula, and the compatibility is reasonable, so that the composition has the effects of replenishing qi and raising yang, benefiting the defense and strengthening the exterior, restoring the pulse and solidifying the body, strengthening the spleen and lungs, and strengthening the body and eliminating evil, and has a significant therapeutic effect. The composition has no adverse effects on the weight gain of mice, and modern pharmacological models have confirmed that it can significantly improve the immunity of mice with high immunosuppression model, which is more significant than the effect of single medicinal materials, meets the evaluation standards for health foods that enhance immunity, and has the function of synergistically enhancing immunity. Moreover, the composition of the present invention is prepared from natural Chinese herbal medicine extracts that are both medicinal and edible, is safe, has no toxic side effects, is harmless to the body, and can nourish the body; the quality is stable and controllable; there is no special odor, the taste is good, and it can be taken directly; it is applicable to a wide range of people, suitable for consumption by middle-aged and elderly people, and can be taken for a long time without adverse reactions, and has high practical application value. DETAILED DESCRIPTION

[0050] The technical solution of the present invention is further described below by specific implementation methods. It should be understood by those skilled in the art that the embodiments are only to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0051] The process, conditions, reagents, test methods, etc. for implementing the present invention, except for the contents specifically mentioned below, are all common knowledge and common common sense in the art, and the present invention has no particular restrictions. The test methods without specifying specific conditions in the embodiments are usually carried out under conventional conditions or under conditions recommended by the manufacturer.

[0052] Unless otherwise specified, the meanings of all professional terms and scientific terms used in this specification are the same as those generally understood by technicians in the technical field to which the invention belongs. However, in case of conflict, the present specification including the definitions shall prevail.

[0053] Example 1 Preparation of food-drug extract for improving immunity

[0054] (1) Preparation method of Gastrodia elata extract:

[0055] The raw materials of Gastrodia elata were crushed and passed through a 20-mesh sieve to remove fine powder and impurities to obtain crude powder of the medicinal materials; the crude powder of the medicinal materials was poured into an extraction tank, and water 10 to 12 times the weight of the medicinal materials was added, and the medicinal materials were soaked for 50 minutes; the soaked medicinal materials were heated and boiled for 2 hours, filtered, and the supernatant was taken for standby use; the residues after extraction and filtration were added with 8 to 10 times the weight of water again, heated and boiled for 2 hours, filtered, and the supernatant was taken; the supernatants of the two filtrations were combined, transferred to an evaporation tank, and heated and concentrated to a specific gravity of 1.08 to 1.15 g / cm 3 Filter and remove impurities, collect the filtrate; the filtrate is then concentrated to a specific gravity of 1.20~1.30g / cm 3 extract; the extract is transferred to a tray, evenly spread, and placed in a freezer for quick freezing; the frozen extract is transferred to a freezing chamber for programmed freeze drying, freeze drying until the moisture content is less than 5.0%, obtaining a dry product, crushing and sieving, and obtaining the Gastrodia elata extract.

[0056] (2) The preparation method and process of ginseng extract, American ginseng extract, Codonopsis pilosula extract, Astragalus extract and Ophiopogon japonicus extract are as follows: (1) Preparation method of Gastrodia elata extract

[0057] Example 2 Preparation of edible and medicinal composite granules for improving immunity

[0058] In this embodiment, the components are composed of the following mass percentage components: 20% of Gastrodia elata extract, 13% of ginseng extract, 12% of American ginseng extract, 14% of Codonopsis pilosula extract, 16% of Astragalus extract, 15% of Ophiopogon japonicus extract solid powder, and 10% of stevioside.

[0059] Preparation method:

[0060] Each of the extract powders and stevia is crushed and passed through a 60-mesh sieve to remove coarse particles, and mixed evenly;

[0061] The extract mixture was granulated with 75% by weight of food grade ethanol and sieved through 20 mesh;

[0062] Dry at 50-55°C, determine the moisture content according to the method of the Pharmacopoeia of the People's Republic of China, Part II, 2020 edition, and control the moisture content to 5%;

[0063] The dried granules are sieved through a 20-mesh sieve, and then 0.5% (by weight of granules) of micro-powdered silica gel is added as an auxiliary material. After mixing evenly, the mixture is bagged to obtain granules.

[0064] Example 3 Preparation of capsules of medicine-food combination for improving immunity

[0065] In this embodiment, the components are composed of the following mass percentage components: 15% of Gastrodia elata extract, 15% of ginseng extract, 10% of American ginseng extract, 19% of Codonopsis pilosula extract, 16% of Astragalus extract, 14% of Ophiopogon japonicus extract solid powder, and 11% of maltodextrin.

[0066] Preparation method:

[0067] Each of the above extract powders and maltodextrin is crushed and passed through a 60-mesh sieve to remove coarse particles, and mixed evenly;

[0068] The extract mixture is mixed with 80% by weight of food-grade ethanol, granulated, and sieved through 20 mesh;

[0069] Put it in a cold oven, turn on the air, and when the surface of the particles turns white, turn them over with a shovel, then heat to 30-35℃, turn them over again after 20-60 minutes, and continue drying;

[0070] When the particles are loosely dispersed, heat them to 50-55°C and dry them. Determine their moisture content according to the method of the Pharmacopoeia of the People's Republic of China, Part II, 2020 edition, and control their moisture content to 5% by weight;

[0071] After the dried particles are cooled, 0.5% (by particle weight) of silicon dioxide is added and mixed, and then filled into 0# capsules to obtain capsules.

[0072] Example 4 Preparation of medicine-food combination tablets for improving immunity

[0073] In this embodiment, the components are composed of the following mass percentage components: 10% of Gastrodia elata extract, 19% of Ginseng extract, 14% of American ginseng extract, 11% of Codonopsis pilosula extract, 17% of Astragalus extract, 13% of Ophiopogon japonicus extract\solid powder, 10% maltodextrin, and 6% sodium carboxymethyl starch.

[0074] Preparation method:

[0075] Each of the extract powders and maltodextrin is crushed and passed through a 60-mesh sieve to remove coarse particles, mixed evenly, and then sodium carboxymethyl starch is added and mixed evenly;

[0076] The extract mixture was mixed with 85% by weight of food grade ethanol, granulated, and sieved through 20 mesh;

[0077] The granules were dried at 50-55°C, and their moisture content was determined according to the method of the Pharmacopoeia of the People's Republic of China, Part II, 2020 edition, and their moisture content was controlled to be 6% by weight;

[0078] The dried granules are sieved through a 20-mesh sieve, 0.5% (by weight of granules) of micro powdered silica gel and 0.5% (by weight of granules) of magnesium stearate are added and mixed evenly, and then compressed to obtain tablets.

[0079] Example 5 Evaluation test of the immunomodulatory function of the composition on immunosuppressed mouse model

[0080] In this example, the immunomodulatory effects of the composition of the present invention and a single-component drug as a comparative example on immunocompromised mice were tested.

[0081] 1. Experimental methods:

[0082] 1.1 Animal grouping

[0083] 120 male mice were adaptively fed for 1 week before the experiment to adapt to the environment. The mice were randomly divided into 10 groups, namely normal control group, model control group, Gastrodia elata group, Ginseng group, American ginseng group, Codonopsis pilosula group, Astragalus group, Ophiopogon japonicus group, Example 2 composition group, Example 3 composition group, Example 4 composition group, and positive control group (RiDaXin).

[0084] 1.2 Immunosuppressed mouse modeling and drug administration in each group

[0085] Normal control group: The mice were raised in groups and isolated from other groups, and were given normal feed and drinking water as needed.

[0086] Model control group: Cyclophosphamide was intraperitoneally injected at a dose of 80 mg / kg on the 7th, 8th and 9th days after the start of the experiment.

[0087] Intervention group: The feeding environment and modeling method were the same as those of the model group. During the 14 days of the experiment, the rats were gavaged daily at the same dose of Gastrodia elata extract, ginseng extract, American ginseng extract, Codonopsis pilosula extract, Astragalus extract, Ophiopogon japonicus extract, Example 2 combination group, Example 3 combination group, and Example 4 combination group.

[0088] The zidaxin group: The feeding environment and modeling method were the same as the model group, and the drug was subcutaneously injected at a dose of 0.2 mg / kg during the 14 days of the experiment.

[0089] 1.3 Detection indicators

[0090] 1.3.1 Organ Index

[0091] The thymus and spleen are the main immune organs of the body. The changes in their mass can reflect the stimulating effect of the test drug on the immune system. Therefore, the thymus and spleen indexes are considered to be important indicators reflecting immune function. After the experiment, the mice were killed, the thymus and spleen were removed, the surface blood was blotted with filter paper and weighed, and the thymus index and spleen index were calculated. Spleen index = spleen weight (mg) / body weight (g); thymus index = thymus weight (mg) / body weight (g).

[0092] 1.3.2 Routine determination of mouse peripheral blood

[0093] Routine blood test data can directly reflect the effect of the composition on cells in the peripheral blood of immunocompromised mice. Leukocytes are one of the main executors of the human immune function, and the level of leukocytes in the blood reflects the strength of the immune function to a certain extent. After cyclophosphamide modeling, there is a significant effect on the parameters of leukocyte indicators in the blood of mice. Whole blood was collected from the eyeballs of mice and collected in anticoagulant tubes. The number of white blood cells (WBC), neutrophils (NEUT), lymphocytes (LYMPH), monocytes (MONO) and other indicators in the blood of mice were detected using a fully automatic cell analyzer.

[0094] 2. Experimental results

[0095] 2.1 Effects on organ indexes of experimental animals

[0096] After 14 days of administration, compared with the blank group, the thymus index and spleen index of the mice in the model group were significantly decreased, indicating that cyclophosphamide can induce immunosuppression in mice. Compared with the model group, the thymus index and spleen index of the mice in the Gastrodia elata group, ginseng group, American ginseng group, Codonopsis pilosula group, Astragalus group, Ophiopogon japonicus group, combination group and Ridaxin group were significantly increased, indicating that each single component group, combination group and Ridaxin had a significant improvement effect on the spleen and thymus damage of mice caused by cyclophosphamide. In addition, compared with the Gastrodia elata group, ginseng group, American ginseng group, Codonopsis pilosula group, Astragalus group and Ophiopogon japonicus group, the thymus index and spleen index of the mice in the combination group were statistically different, indicating that the combination group has a synergistic or synergistic effect. The results are shown in Table 1.

[0097] Table 1

[0098] Group Thymus index (mg / g) Spleen index (mg / g) Blank control group 1.88±0.21 6.37±0.69 Model control group 0.65±0.12# 2.38±0.58# Gastrodia Group 0.81±0.22*^ 3.49±0.52*^ Ginseng Group 1.14±0.34*^ 4.17±0.41*^ American ginseng group 1.18±0.26*^ 4.41±0.54*^ Codonopsis pilosula group 0.91±0.32*^ 3.67±0.32*^ Astragalus group 0.89±0.32*^ 3.47±0.31*^ Ophiopogon japonicus group 0.91±0.22*^ 3.98±0.44*^ Example 2 Composition Group 1.94±0.29* 6.19±0.55* Example 3 Composition Group 1.73±0.32* 5.67±0.46* Example 4 Composition Group 1.86±0.18* 5.87±0.39* Positive control group 1.67±0.35* 5.68±0.43*

[0099] Note: Compared with the blank control group, #P< 0.05; compared with the model control group, *P< 0.05; compared with the combination group, ^P< 0.05.

[0100] 2.2 Effects on peripheral blood routine of experimental animals

[0101] Compared with the blank control group, the content of white blood cells (WBC), lymphocytes (LYMPH), neutrophils (NEUT), and monocytes (MONO) in the peripheral blood of mice in the model group was significantly reduced. Compared with the model group, the Gastrodia elata group, the Ginseng group, the American Ginseng group, the Codonopsis pilosula group, the Astragalus group, the Radix Ophiopogonis group, the combination group, and the Ridaxan group were able to significantly increase the content of white blood cells (WBC), lymphocytes (LYMPH), neutrophils (NEUT), and monocytes (MONO) in the blood routine of immunocompromised mice. In addition, compared with the Gastrodia elata group, the Ginseng group, the American Ginseng group, the Codonopsis pilosula group, the Astragalus group, and the Radix Ophiopogonis group, the white blood cells (WBC), lymphocytes (LYMPH), neutrophils (NEUT), and monocytes (MONO) in the combination group were statistically different, indicating that the combination group had a synergistic or synergistic effect. The results are shown in Table 2.

[0102] Table 2

[0103]

[0104] Note: Compared with the blank control group, #P< 0.05; compared with the model control group, *P< 0.05; compared with the combination group, ^P< 0.05.

[0105] 3. Experimental conclusions and discussion

[0106] After 14 days of administration, the composition can significantly increase the spleen index and thymus index of immunocompromised mice, and significantly increase the number of white blood cells, lymphocytes, neutrophils and monocytes in the peripheral blood routine of immunocompromised mice, indicating that the composition can improve the spleen and thymus damage of immunocompromised mice induced by cyclophosphamide. In addition, the effect of the combination is significantly stronger than that of each single group, indicating that the combination group has a synergistic or synergistic effect.

[0107] Example 6 Evaluation test of the effect of the composition on the immune function of mice

[0108] In this example, the effects of the composition of the present invention and the single-component drug as a comparative example on the immune function of mice were tested from four aspects: cellular immune function, humoral immune function, monocyte-macrophage function, and natural killer cell (NK) activity.

[0109] 1. Experimental methods:

[0110] 1.1 Animal grouping

[0111] A total of 330 healthy male mice of the Kunming strain of SPF (specific pathogen free) were selected and randomly divided into three groups according to their body weight, with 110 mice in each group. The three groups were immune group 1, immune group 2, and immune group 3, respectively.

[0112] 1.2 Experimental samples

[0113] Sheep red blood cells (SRBC), Hank's solution (balanced salt solution) (pH 7.2~7.4), RPMI1640 culture medium, calf serum, penicillin-streptomycin, concanavalin A (ConA), MTT (methylthiazolium tetrazolium), complement (guinea pig serum), SA buffer, India ink, Dulbecco's reagent, YAC-1 cells, etc.

[0114] 1.3 Modeling method

[0115] The mice were divided into three groups: delayed-type hypersensitivity (DTH) and the number of antibody-producing cells were measured in group 1; ConA-induced mouse lymphocyte transformation and NK cell activity were measured in group 2; and carbon clearance was performed in group 3. Adaptive feeding was performed for 3 days.

[0116] 110 mice in each group were randomly divided into 11 groups, namely blank control group, model control group, Gastrodia elata group, Ginseng group, American ginseng group, Codonopsis pilosula group, Astragalus membranaceus group, Ophiopogon japonicus group, Composition group of Example 2, Composition group of Example 3, Composition group of Example 4. The blank control group and the model control group were given 1mL / 10g distilled water; the intervention group was given the same volume of Gastrodia elata, Ginseng, American ginseng, Codonopsis pilosula, Astragalus membranaceus, Ophiopogon japonicus, and the combination. The mice were gavaged continuously for 15 days. 10 days before the end of the experiment, mice in the intervention group and the model group were intraperitoneally injected with 80 mg / kg of cyclophosphamide injection for 3 consecutive days to cause immunosuppressed mice. The blank group was intraperitoneally injected with an equal volume of normal saline (0.1mL / 10g).

[0117] 1.4 Detection indicators

[0118] 1.4.1 Cellular immune function

[0119] Delayed-type hypersensitivity (DTH) (plantar thickening method): 4 days after sensitization of mice by intraperitoneal injection of 2% packed SRBC (0.2 ml / mouse), the thickness of the left hind paw was measured. Then 20% (v / v) SRBC (20 μL / mouse) was subcutaneously injected at the measurement site. The thickness of the left hind paw was measured 24 h after injection. The same site was measured three times and the average value was taken. The difference in thickness between the anterior and hind paw (plantar swelling) was used to express the degree of DTH.

[0120] ConA-induced mouse lymphocyte transformation test (MTT method): Aseptically take the spleen, grind it with forceps in a plate containing sterile Hank's solution to make a cell suspension, filter it through a 200-mesh sieve, wash it twice with Hank's solution, centrifuge it for 10 minutes each time (1000r / min), then take the precipitate and suspend it in 1mL of complete culture medium, stain it with trypan blue and count it (should be above 95%). Adjust the cell concentration to 3×10 6 / mL, then the cell suspension was added to two wells of a 24-well culture plate, 1 mL per well, 75μL ConA solution was added to one well, and the other well was used as a control, and then placed in a 5% CO2 incubator at 37℃ for 72h. 4h before the end of the culture, 0.7mL of supernatant was gently aspirated from each well, 0.7mL of RPMI1640 culture solution without calf serum was added, and 50μL / well of MTT (5mg / mL) was added and continued to be cultured for 4h. After the end of the culture, 1mL of acidic isopropanol was added to each well to completely dissolve the purple product, and then it was dispensed into a 96-well culture plate, 3 parallel wells were made in each well, and the optical density value was measured at a wavelength of 570nm using an enzyme reader. The proliferation capacity of lymphocytes is expressed by the A value of the well with ConA added minus the A value of the well without ConA added.

[0121] 1.4.2 Humoral immune function

[0122] Antibody-producing cell detection (Jerne modified slide method): 0.2 mL of 2% packed SRBC was injected intraperitoneally into each mouse. The mice were killed by cervical dislocation 5 days after immunization. The spleen was removed and placed in a plate containing Hank's solution. The spleen was ground to make a cell suspension, filtered through a 200-mesh sieve, centrifuged (1000 r / min) for 10 min, washed twice with Hank's solution, and finally suspended in 5 mL of RPMI1640 culture medium. The cells were counted by trypan blue staining (should be above 95%), and the cell concentration was adjusted to 5×10 6 / mL, and make a spleen cell suspension. Prepare agarose into a 1% aqueous solution, boil it in a water bath for 30 minutes, mix it with an equal amount of double-concentration Hanks solution, and dispense it into small test tubes, 0.5mL per tube, and then add 10% (prepared with SA buffer) SRBC 50μL to the tube, and make two parallel samples of spleen cell suspension 20μL, quickly mix it, and pour it on the agarose thin layer glass slide. After the agar solidifies, put the glass slide horizontally on the slide rack, put it in a carbon dioxide incubator and incubate it for 1.5h, then add complement to the groove of the slide rack, continue to incubate for 1.5h, and count the number of hemolytic plaques. The preparation of complement is to collect guinea pig blood, separate serum (mixed serum of at least 5 guinea pigs), add 1mL of SRBC to 5mL of guinea pig serum, place it in a refrigerator at 4℃ for 30min, shake it frequently, centrifuge it to take the supernatant, dispense it, and store it at -70℃. When used, dilute it with SA buffer at 1:15.

[0123] 1.4.3 Monocyte-macrophage phagocytosis

[0124] Mouse carbon clearance test was used to detect the phagocytic function of mouse monocytes. 25% India ink was injected into the mouse tail vein at a dose of 0.1 mL / 10 g. 25 μL of blood was collected from the mouse orbital venous plexus at 5 min and 20 min after injection, dissolved in 2 mL of 0.1% Na2CO3 solution and shaken well. 0.1% Na2CO3 was used as a blank control, and the absorbance was measured at 600 nm by a spectrophotometer. The mouse was dissected and the liver and spleen were weighed, and the clearance index K and the corrected clearance index α were calculated. Where K=(1gA1-lgA2) / (t2-t1); α=K1 / 3 body weight / (liver weight + spleen weight). Where A1 and A2 represent the absorbance measured twice, and t2-t1 represents the time interval between the two blood draws.

[0125] 1.4.4 NK cell activity assay

[0126] The lactate dehydrogenase (LDH) assay was used to detect NK cell activity. YAC-1 cells were subcultured 24 h before the experiment and the cell concentration was adjusted to 4×10 5 After the animal was given the drug, the spleen was removed aseptically and placed in a small dish containing an appropriate amount of sterile Hank's solution. The spleen was gently ground with tweezers to make a single cell suspension. Filtered through a 200-mesh sieve, 0.5 mL of sterile water was added for 20 seconds to lyse the red blood cells, and the cell concentration was adjusted to 2×10 with RPMI1640 complete culture medium. 7 / mL. Take 100μL of YAC-1 cells and spleen cells, add them to a 96-well culture plate; add 100μL of target cells and culture medium to the target cell natural release well, and add 100μL of target cells and 2.5% Triton to the target cell maximum release well; set up 3 duplicate wells for each of the above items, culture in a 37℃, 5% CO2 incubator for 4h, then centrifuge the 96-well culture plate at (1500r / min) for 5min, aspirate 100μL of supernatant from each well and place it in a flat-bottomed 96-well culture plate, add 100μL of LDH matrix solution at the same time, react for 3min, add 30μL of 1mol / L hydrochloric acid solution to each well, and measure the A value at 490nm on an ELISA reader.

[0127] NK cell activity (%) = (reaction A value - natural release hole A value) / (maximum release hole A value - natural release hole A value) × 100%.

[0128] 2. Experimental results

[0129] Excel and SPSS19.0 software were used for data transformation and statistical analysis. After the variance homogeneity test was passed, single-factor multiple comparison statistical analysis was used.

[0130] 2.1 Cellular immune function

[0131] In the delayed-type hypersensitivity experiment of mice, compared with the blank control group, the delayed-type hypersensitivity of the model group was significantly reduced (P<0.01). Compared with the model group, the intervention group significantly increased the intensity of delayed-type hypersensitivity of mice (P<0.01), indicating that the composition of the present invention can increase the delayed-type hypersensitivity of mice. In addition, the effect of the composition is significantly stronger than that of each single group, indicating that the combination group has a synergistic or synergistic effect. The results are shown in Table 3.

[0132] In the experiment of mouse spleen lymphocyte transformation induced by concanavalin A (ConA), the difference of A value in the intervention group was higher than that in the model control group, and the difference was significant, indicating that the intervention group could improve the ability of mouse spleen lymphocyte transformation. In addition, the effect of the combination was significantly stronger than that of each single group, indicating that the combination group had a synergistic or synergistic effect. The results are shown in Table 3.

[0133] Table 3

[0134] Group Toe thickness difference (mm) A value difference Blank control group 0.78±0.31 0.468±0.083 Model control group 0.25±0.22# 0.228±0.059# Gastrodia Group 0.43±0.13*^ 0.339±0.032*^ Ginseng Group 0.54±0.32*^ 0.407±0.051*^ American ginseng group 0.58±0.24*^ 0.409±0.064*^ Codonopsis pilosula group 0.45±0.16*^ 0.352±0.024*^ Astragalus group 0.59±0.24*^ 0.418±0.032*^ Ophiopogon japonicus group 0.42±0.15*^ 0.361±0.026*^ Example 2 Composition Group 0.78±0.26* 0.481±0.019* Example 3 Composition Group 0.69±0.19* 0.446±0.012* Example 4 Composition Group 0.72±0.21* 0.469±0.011*

[0135] Note: Compared with the blank control group, #P< 0.05; compared with the model control group, *P< 0.05; compared with the combination group, ^P< 0.05.

[0136] 2.2 Humoral immune function

[0137] In the mouse antibody-producing cell experiment, the number of hemolytic plaques in the intervention group and the model control group was significantly different (P<0.05), indicating that the number of antibody-producing cells in mice can be increased and the humoral immunity of mice can be enhanced. In addition, the effect of the combination is significantly stronger than that of each single group, indicating that the combination group has a synergistic or synergistic effect. The results are shown in Table 4.

[0138] Table 4

[0139] Group <![CDATA[Number of hemolytic plaques (10 3 splenocytes)]]> Blank control group 23.86±6.79 Model control group 10.37±5.47# Gastrodia Group 15.43±7.16*^ Ginseng Group 18.35±6.28*^ American ginseng group 19.35±6.47*^ Codonopsis pilosula group 16.57±5.23*^ Astragalus group 19.79±4.59*^ Ophiopogon japonicus group 15.78±4.16*^ Example 2 Composition Group 24.38±5.98* Example 3 Composition Group 21.46±4.79* Example 4 Composition Group 22.67±3.99*

[0140] Note: Compared with the blank control group, #P< 0.05; compared with the model control group, *P< 0.05; compared with the combination group, ^P< 0.05.

[0141] 2.3 Monocyte-macrophage phagocytosis

[0142] In the mouse carbon clearance experiment, compared with the blank control group, the carbon clearance function of immunocompromised mice in the model control group was significantly reduced (P<0.01). Compared with the model control group, the carbon clearance function of mice in the intervention group was significantly improved (P<0.05). This shows that it has the effect of enhancing the phagocytic function of mouse monocytes and giant cells. In addition, the effect of the combination is significantly stronger than that of each single group, indicating that the combination group has a synergistic or synergistic effect. The results are shown in Table 5.

[0143] Table 5

[0144] Group Phagocytic index (α) Blank control group 4.46±0.58 Model control group 2.28±0.49# Gastrodia Group 3.25±0.45*^ Ginseng Group 3.66±0.56*^ American ginseng group 3.77±0.52*^ Codonopsis pilosula group 3.16±0.56*^ Astragalus group 3.84±0.51*^ Ophiopogon japonicus group 3.19±0.47*^ Example 2 Composition Group 4.59±0.47* Example 3 Composition Group 4.23±0.35* Example 4 Composition Group 4.38±0.37*

[0145] Note: Compared with the blank control group, #P< 0.05; compared with the model control group, *P< 0.05; compared with the combination group, ^P< 0.05.

[0146] 2.4 NK cell activity assay

[0147] In the experiment of detecting NK cell activity by lactate dehydrogenase (LDH) assay, the NK cell activity of the model control group was significantly reduced compared with the blank control group (P<0.01). Compared with the model control group, the NK cell activity of the intervention group mice was significantly increased (P<0.05). This indicates that it has the effect of enhancing the NK cell activity of mice. In addition, the effect of the combination is significantly stronger than that of each single group, suggesting that the combination group has a synergistic or synergistic effect. The results are shown in Table 6.

[0148] Table 6

[0149] Group NK cell activity (%) Blank control group 27.76±4.91 Model control group 9.68±2.32# Gastrodia Group 15.57±4.37*^ Ginseng Group 22.59±3.19*^ American ginseng group 23.49±3.03*^ Codonopsis pilosula group 15.57±4.26*^ Astragalus group 22.59±3.19*^ Ophiopogon japonicus group 14.38±4.15*^ Example 2 Composition Group 28.89±2.87* Example 3 Composition Group 25.96±3.15* Example 4 Composition Group 26.99±2.98*

[0150] Note: Compared with the blank control group, #P< 0.05; compared with the model control group, *P< 0.05; compared with the combination group, ^P< 0.05.

[0151] The composition of the present invention can significantly improve the intensity of delayed-type hypersensitivity in mice; can enhance the transformation and proliferation ability of mouse spleen lymphocytes induced by concanavalin A (ConA), and has the effect of enhancing cellular immune function; can increase the number of antibody-producing cells in mice, and has the effect of enhancing humoral immune function; and has the effect of enhancing the phagocytic function of mouse monocytes and macrophages and enhancing the activity of mouse NK cells. In addition, the effect of the composition is significantly stronger than that of each single group, indicating that the combination group has a synergistic or synergistic effect. It shows that the composition of the present invention has a certain effect of enhancing the immunity function.

[0152] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

[0153] The applicant declares that the present invention illustrates a medicine-food composition and its preparation method and application through the above-mentioned embodiments, but the present invention is not limited to the above-mentioned embodiments, that is, it does not mean that the present invention must rely on the above-mentioned embodiments to be implemented. Those skilled in the art should understand that any improvement of the present invention, equivalent replacement of the raw materials of the product of the present invention, addition of auxiliary ingredients, selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

[0154] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, a variety of simple modifications can be made to the technical solution of the present invention, and these simple modifications all belong to the protection scope of the present invention.

[0155] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

Claims

1. A medicine-food composition having the function of improving immunity, characterized in that: The medicine-food composition, measured by mass percentage, consists of 5%-30% of Gastrodia elata extract, 5%-25% of Ginseng extract, 5%-25% of American ginseng extract, 5%-25% of Codonopsis pilosula extract, 5%-25% of Astragalus membranaceus extract and 5%-25% of Ophiopogon japonicus extract, or consists of 5%-30% of Gastrodia elata extract, 5%-25% of Ginseng extract, 5%-25% of American ginseng extract, 5%-25% of Codonopsis pilosula extract, 5%-25% of Astragalus membranaceus extract and 5%-25% of Ophiopogon japonicus extract and pharmaceutically acceptable excipients.

2. The medicine-food composition for improving immunity according to claim 1, characterized in that: The medicine-food composition comprises, by mass percentage, 10%-25% of Gastrodia elata extract, 10%-20% of Ginseng extract, 10%-20% of American ginseng extract, 10%-20% of Codonopsis pilosula extract, 10%-20% of Astragalus extract, and 10%-20% of Ophiopogon japonicus extract.

3. The medicine-food composition for improving immunity according to claim 1, characterized in that: The medicine-food composition comprises, by mass percentage, 20% of Gastrodia elata extract, 13% of Ginseng extract, 12% of American ginseng extract, 14% of Codonopsis pilosula extract, 16% of Astragalus membranaceus extract, and 15% of Ophiopogon japonicus extract; or 15% of Gastrodia elata extract, 15% of Ginseng extract, 10% of American ginseng extract, 19% of Codonopsis pilosula extract, 16% of Astragalus membranaceus extract, and 14% of Ophiopogon japonicus extract; or 10% of Gastrodia elata extract, 19% of Ginseng extract, 14% of American ginseng extract, 11% of Codonopsis pilosula extract, 17% of Astragalus membranaceus extract, and 13% of Ophiopogon japonicus extract.

4. The edible-medicinal composition according to any one of claims 1 to 3, characterized in that: Each of the extracts is prepared from the pharmacopoeial part of the medicinal material, which is crushed, extracted, separated and purified to obtain a solid powder; the extraction methods are all water extraction methods.

5. The medicine-food composition according to any one of claims 1 to 3, characterized in that: The medicine-food composition also includes a sweetener; The mass percentage of the sweetener is 1-20%; The sweetener is selected from one or more of sorbitol, maltitol, isomalt, xylitol, lactitol, mannitol, erythritol, isomalt-oligosaccharide, stevioside, licorice, disodium glycyrrhizinate, tripotassium glycyrrhizinate and trisodium glycyrrhizinate.

6. A method for preparing the medicine-food composition according to any one of claims 1 to 3, characterized in that: Gastrodia elata extract, ginseng extract, American ginseng extract, Codonopsis pilosula extract, Astragalus membranaceus extract and Ophiopogon japonicus extract are weighed according to weight ratio, sieved, added with conventional auxiliary materials and mixed evenly to obtain a compatible composition.

7. Use of the medicine-food composition as claimed in any one of claims 1 to 3 in the preparation of medicines or foods for improving immunity.

8. A Chinese medicine preparation for improving immunity, characterized in that: The traditional Chinese medicine preparation comprises the medicine-food composition as described in any one of claims 1 to 3.

9. The Chinese medicine preparation according to claim 8, characterized in that: The dosage form of the Chinese medicine preparation is selected from decoction, tablet, powder, powder, pill, granule, oral liquid, capsule or paste dosage form.

10. A health product that helps improve immunity, characterized in that: The health product comprises the medicine-food composition as described in any one of claims 1 to 3.

Images