Ginseng composition for improving myocardial function as well as preparation method and application thereof

Abstract

The invention relates to the technical field of biological medicine, and discloses a ginseng composition for improving myocardial function as well as a preparation method and application thereof. The ginseng composition comprises the following components in parts by mass: 9-11 parts of a ginseng extract, 14-16 parts of astragalus membranaceus powder, 11-13 parts of spina date seed powder, 5-7 parts of earthworm protein powder, 5-7 parts of natto powder, 9-11 parts of radix ophiopogonis powder, 5-7 parts of schisandra chinensis powder, 9-11 parts of poria cocos powder, 5-7 parts of liquorice powder, 7-9 parts of polygala tenuifolia powder, 5-7 parts of rhizoma acori graminei powder and 9-11 parts of asparagus cochinchinensis powder. In the scheme, the ginseng extract is combined with the various traditional Chinese medicine components with the cardiovascular regulation function, and all the components generate a comprehensive regulation effect on the myocardial function through a synergistic effect; the ginseng composition can be prepared into capsules, tablets, pills, powder and oral liquid, and is convenient to eat.

Description

Technical Field

[0001] The present invention relates to the technical field of biomedicine, and in particular to a ginseng composition for improving myocardial function, and a preparation method and application thereof. Background Art

[0002] Cardiovascular diseases seriously threaten human health, among which myocardial dysfunction is a common and critical problem. Although modern medicine has made some progress in the treatment of myocardial dysfunction, there are still many limitations, such as some drugs have serious side effects and unstable long-term efficacy.

[0003] Ginseng is widely used in traditional medicine. The various ginsenosides (such as Rb1, Rg1, Rg2, etc.) it contains have important regulatory effects on the cardiovascular system. Astragalus has the effects of replenishing qi and raising yang, consolidating the exterior and stopping sweating, which can enhance the body's immunity and also have a certain protective and improving effect on myocardial function. Ziziphus jujuba seeds can nourish the heart and liver, calm the mind and soothe the nerves, help relieve the anxiety and other negative emotions often associated with patients with cardiovascular diseases, and indirectly have a positive effect on myocardial function. Pheretima protein has the effects of dissolving blood clots and improving microcirculation, which can promote myocardial blood perfusion. After processing, natto contains a variety of bioactive ingredients, which helps to lower blood lipids and improve the cardiovascular environment. Ophiopogon japonicus can nourish yin and produce fluid, moisten the lungs and clear the heart, and has a certain improvement effect on myocardial ischemia. Schisandra chinensis can astringe and consolidate, replenish qi and produce fluid, and can regulate the function of the cardiovascular system. Poria has the effects of diuresis and dampness, invigorating the spleen and calming the heart, which is beneficial to regulating the body's water metabolism balance, and thus has a beneficial effect on heart function. Licorice has the effects of tonifying the spleen and replenishing qi, harmonizing various medicines, etc., can enhance the body's adaptability to drugs, and cooperate with other drugs to play a role. Polygala and Acorus calamus have the effects of calming the nerves and improving intelligence, can improve the overall state of patients, and also have a certain auxiliary effect on the recovery of myocardial function. Asparagus has the effects of nourishing yin and moistening dryness, clearing the lungs and promoting body fluid, and has a regulating effect on the metabolic environment of myocardial cells. In the prior art, there are few reports that earthworm protein and natto are used simultaneously to improve cardiovascular system blood circulation and myocardial function. However, there is a lack of a composition that reasonably combines these effective ingredients and has a significant synergistic effect on improving myocardial function on the market. Summary of the invention

[0004] The purpose of the present invention is to provide a ginseng composition for improving myocardial function and a preparation method and application thereof, so as to solve the problems raised in the prior art.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] A method for preparing a ginseng composition for improving myocardial function comprises the following steps:

[0007] Ginseng extract, astragalus powder, spiny jujube seed powder, ophiopogon powder, schisandra powder, tuckahoe powder, licorice powder, polygala powder, calamus powder, asparagus powder, earthworm protein powder and natto powder are uniformly mixed to obtain a ginseng composition.

[0008] More optimally, the ginseng composition includes the following components: by mass, 9-11 parts of ginseng extract, 14-16 parts of astragalus powder, 11-13 parts of jujube seed powder, 5-7 parts of earthworm protein powder, 5-7 parts of natto powder, 9-11 parts of ophiopogon powder, 5-7 parts of schisandra powder, 9-11 parts of poria powder, 5-7 parts of licorice powder, 7-9 parts of polygala powder, 5-7 parts of calamus powder, and 9-11 parts of asparagus powder.

[0009] More optimally, the ginseng composition includes the following components: by mass, 10 parts of ginseng extract, 15 parts of astragalus powder, 12 parts of jujube seed powder, 6 parts of earthworm protein powder, 6 parts of natto powder, 10 parts of ophiopogon powder, 6 parts of schisandra powder, 10 parts of poria powder, 6 parts of licorice powder, 8 parts of polygala powder, 6 parts of calamus powder, and 10 parts of asparagus powder.

[0010] In the program, the active ingredients in earthworm protein and natto work synergistically to effectively improve blood circulation in the cardiovascular system; earthworm protein can dissolve blood clots, and nattokinase can lower blood lipids. The two work together to reduce blood viscosity, prevent thrombosis, and increase blood supply to the myocardium; moreover, they can also synergistically regulate the function of vascular endothelial cells, promote the release of vasodilator factors, maintain normal tension of blood vessels, and ensure that the myocardium obtains sufficient oxygen and nutrients, thereby helping to improve myocardial function.

[0011] In the scheme, ingredients such as Chinese jujube seeds and Schisandra chinensis work synergistically to regulate the function of the nervous system; Chinese jujube seeds can reduce the excitability of the central nervous system, and Schisandra chinensis can regulate the balance of the autonomic nervous system. The two together can relieve the common negative emotions such as anxiety and tension in patients with cardiovascular diseases and stabilize the autonomic nervous system; this helps to reduce the stress response of the heart, reduce myocardial oxygen consumption, indirectly have a positive effect on myocardial function, and reduce the risk of cardiovascular events.

[0012] In the scheme, astragalus, poria cocos, licorice, etc. work together to regulate the body's physiological functions; astragalus enhances the body's immunity, and its ingredients such as astragalus polysaccharides can activate immune cells and enhance the body's immune defense capabilities; poria cocos regulates the balance of water metabolism, and its main ingredient, poria polysaccharide, has diuretic and osmotic pressure regulating effects, which helps to reduce the burden on the heart; licorice harmonizes the various medicines and reduces the stimulation of the drugs to the body. At the same time, ingredients such as glycyrrhizic acid have certain anti-inflammatory and anti-allergic effects, and can work together with other ingredients to promote the recovery of myocardial function, create a good internal environment for myocardial cells, and enhance the heart's resistance to various injuries.

[0013] In the plan, Polygala tenuifolia and Acorus calamus have calming and intellectual effects, and can improve the patient's overall mental state; Polygala tenuifolia contains ingredients such as polygala saponins, which can enhance memory and improve sleep quality, and Acorus calamus contains ingredients such as volatile oils, which can invigorate the brain, soothe the mind and improve intelligence. The synergistic effect of the two can reduce the psychological pressure caused by the disease and enable patients to maintain a good mental state; this is beneficial to the improvement of myocardial function, because psychological factors have an important impact on the health of the cardiovascular system.

[0014] In the program, asparagus has a regulatory effect on the metabolic environment of cardiomyocytes. The various active ingredients it contains, such as asparagine and steroidal saponins, can participate in the material metabolism and energy conversion process of cardiomyocytes; working together with other ingredients, it helps to maintain the normal metabolism and function of cardiomyocytes, and enhance the tolerance of cardiomyocytes to adverse environments such as ischemia and hypoxia.

[0015] The most optimized preparation method of the ginseng extract is as follows: (1) crushing the ginseng medicinal material into coarse powder, adding ethanol aqueous solution, heating and refluxing extraction 2 to 3 times, combining the extracts, filtering, and reducing the pressure of the filtrate to recover ethanol until there is no ethanol taste, thereby obtaining an ethanol extract; (2) eluting the ethanol extract through a macroporous resin column, reducing the pressure and concentrating to dryness, thereby obtaining a ginseng extract.

[0016] More optimally, the concentration of the ethanol aqueous solution is 70% to 80%, the amount of ethanol aqueous solution added is 5 to 10 times the amount of ginseng medicinal materials, and the time for each reflux extraction is 1 to 2 hours; during the elution process, water and 30% to 50% ethanol aqueous solution are used for elution in turn.

[0017] More optimally, in the ginseng extract, the content of ginsenoside Rb1 is 15%, the content of Rg1 is 10%, and the content of Rg2 is 8%.

[0018] More optimally, the natto powder is prepared by screening, washing, soaking, steaming, processing, drying and crushing natto into fine powder; the earthworm protein powder is prepared by freeze-drying; the astragalus powder, spiny jujube seed powder, ophiopogon powder, schisandra powder, poria powder, licorice powder, polygala powder, calamus powder and asparagus powder are prepared by washing, drying and crushing astragalus, spiny jujube seed, ophiopogon, schisandra, poria, licorice, polygala, calamus and asparagus into fine powder.

[0019] In the scheme, the principle of extracting ginseng extract is to use the solubility of ethanol to extract the active ingredients in ginseng; ethanol, as a commonly used organic solvent, can dissolve various fat-soluble and water-soluble components such as ginsenosides in ginseng. Heating and refluxing can improve the extraction efficiency, and multiple extractions can ensure that as many active ingredients as possible are extracted; the drug residue is removed by filtration to obtain an ethanol extract containing various ginsenosides and other components; then the ethanol extract is dissolved in water to facilitate subsequent separation and purification through a macroporous adsorption resin column;

[0020] The macroporous adsorption resin has a porous structure and a large specific surface area, and can selectively adsorb and separate substances according to differences in polarity, molecular size, etc.; it is first eluted with water to remove some impurities with greater polarity; then it is eluted with 30wt% to 50wt% ethanol. At this time, target components such as ginsenosides can be effectively eluted at this concentration of ethanol, while other impurities are retained on the resin column, thereby achieving preliminary purification of the ginseng extract and increasing the content of effective ingredients such as ginsenosides Rb1, Rg1, and Rg2.

[0021] Washing is to remove impurities on the surface of the medicinal materials, drying is to facilitate crushing and subsequent storage, and crushing into fine powder can increase the surface area of ​​the medicinal materials, which is conducive to better functioning in the composition and improving the absorption and utilization rate of the drug.

[0022] The freeze-drying method can sublime the water in the earth dragon protein at low temperature, thereby maintaining the activity and structural integrity of the earth dragon protein. The resulting powdered earth dragon protein is easier to mix evenly with other ingredients and has better stability during storage and use.

[0023] Steaming and processing can change the properties of natto, making it more suitable for medicinal use. For example, steaming may change some components in natto, enhancing its medicinal effects or reducing its toxicity. Drying and crushing are also for the convenience of subsequent mixing and preparation molding.

[0024] A ginseng composition prepared by a method for preparing a ginseng composition for improving myocardial function;

[0025] The ginseng composition is used to prepare capsules, tablets, pills, powders and oral liquids.

[0026] More optimally, when the ginseng composition is made into capsules, the ginseng composition is uniformly mixed with starch and dextrin to obtain a powder; granulated, dried, and filled into capsules to obtain a finished product;

[0027] When the ginseng composition is made into tablets, the ginseng components are added into deionized water to make a soft material, and the soft material is pressed into tablets to obtain tablets;

[0028] When the ginseng composition is made into pills, the ginseng composition and honey are mixed evenly to make pills;

[0029] When the ginseng composition is prepared into a powder, the ginseng composition is ground into fine powder, and sieved to obtain a powder;

[0030] When the ginseng composition is made into an oral liquid, the ginseng composition is added to deionized water, heated and refluxed for extraction twice, each extraction lasting 2 hours, the extracts are combined, filtered, concentrated, flavoring agents and preservatives are added, and mixed uniformly to obtain an oral liquid.

[0031] More optimally, each capsule contains 0.5 g of drug powder; each tablet weighs 0.5 g; each pill weighs 3 g; and each oral liquid contains 10 mL.

[0032] In the scheme, ginsenosides in ginseng extract work synergistically with other ingredients in the ginseng composition to significantly improve myocardial function; ginsenoside Rb1 can enhance myocardial contractility by regulating the calcium channels of myocardial cells, while astragalus polysaccharides and other ingredients in astragalus can enhance the body's immunity and promote the repair and regeneration of myocardial cells. The two work synergistically to better maintain the normal function of the myocardium; at the same time, ginsenoside Rg1 can promote the energy metabolism of myocardial cells, and work synergistically with astragalus to further enhance the vitality of myocardial cells and improve the heart's blood pumping ability.

[0033] In the scheme, the ginseng combination can act on multiple targets. At the myocardial cell level, ingredients such as ginsenosides can regulate the energy metabolism and ion channels of myocardial cells. Ginsenoside Rg2 can activate mitochondrial function in myocardial cells, promote the synthesis of adenosine triphosphate (ATP), and provide sufficient energy for myocardial contraction. At the same time, it can regulate calcium ion channels to ensure the normal rhythm of myocardial cell contraction and relaxation.

[0034] At the vascular level, ingredients such as earthworm protein and natto can act on vascular endothelial cells, regulate vascular tension, inhibit platelet aggregation, etc.; they can inhibit the activity of angiotensin converting enzyme, reduce the production of angiotensin II, and thus lower vasoconstrictive pressure; inhibit platelet adhesion, aggregation and release reactions, prevent thrombosis, and improve myocardial blood perfusion; at the nervous system level, ingredients such as Chinese jujube seeds can regulate the release of neurotransmitters and the excitability of nerve cells; Chinese jujube seeds can increase the content of inhibitory neurotransmitters such as γ-aminobutyric acid (GABA) in the brain, reduce the excitability of neurons, and stabilize the regulation of the heart by the autonomic nervous system; at the level of the whole body, ingredients such as astragalus can regulate the body's immune function and physiological state, provide a good internal environment for the improvement of myocardial function, and thus achieve comprehensive regulation of myocardial function.

[0035] In the scheme, uniform mixing is to ensure that the ingredients are evenly distributed in the composition, so as to ensure that the dosage of each ingredient is accurate and can work synergistically each time it is taken; the addition of excipients is to improve the formability and taste of the composition. Starch and dextrin are often used as fillers and adhesives, which are helpful for granulation and molding; granulation can make powdered drugs into granules, which is convenient for packaging, storage and administration. Drying is to remove moisture from the granules to ensure the stability of the product. Finally, they are filled into capsules or pressed into tablets for patients to take. At the same time, it can also protect the drug ingredients from the influence of the external environment and improve the stability and shelf life of the drugs.

[0036] In the scheme, the advantages of pills are that they are easy to take, especially suitable for some elderly people or patients who are accustomed to taking pills, and easy to store, and can maintain stable efficacy for a long time at room temperature;

[0037] The powder preparation process is simple, the effect is fast, and the dosage can be flexibly adjusted according to the patient's condition. It is suitable for some situations where the condition is more urgent or requires a fast effect, such as the initial stage of adjuvant treatment for acute myocardial injury.

[0038] The oral liquid has a good taste and is easy to absorb. It is especially suitable for children or patients with swallowing difficulties. It can be quickly absorbed by the human body to exert its medicinal effect.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] In the formula of the present invention, the various ginsenosides (such as Rb1, Rg1, Rg2, etc.) in the ginseng extract have extensive synergistic effects with other ingredients in the ginseng composition; while ginsenoside Rb1 regulates the calcium channels of myocardial cells to enhance myocardial contractility, astragalus polysaccharides enhance the body's immunity and promote myocardial cell repair and regeneration, forming a synergistic maintenance of myocardial cell function from power enhancement to structural repair.

[0041] Ziziphus jujuba seeds reduce the excitability of the central nervous system, and Schisandra chinensis regulates the balance of the autonomic nervous system. The two work together on the nervous system to stabilize the regulation of the heart by the autonomic nervous system and reduce cardiac stress response, which is different from other products that only focus on the cardiovascular system itself; Poria regulates the balance of water metabolism to reduce the burden on the heart, and Licorice harmonizes the various medicines and promotes myocardial function recovery through its anti-inflammatory and anti-allergic effects in synergy with other ingredients, creating a good internal environment for myocardial cells, and providing support for the improvement of myocardial function from the perspective of overall body regulation. This all-round synergistic effect is an important feature of the present invention that distinguishes it from the prior art.

[0042] In the scheme, earthworm protein has the ability to dissolve blood clots and can directly act on the formed blood clots, decompose fibrin, and degrade it into soluble products, thereby restoring blood vessel patency; natto is rich in nattokinase, which can reduce the risk of thrombosis from the source by inhibiting the activity of coagulation factors and reducing the coagulability of blood. At the same time, natto can also reduce blood lipids and improve blood viscosity; the two work together to not only effectively reduce blood viscosity, prevent thrombosis, and increase blood supply to the myocardium, but also synergistically regulate the function of vascular endothelial cells, promote the release of vasodilator factors, maintain normal tension of blood vessels, and ensure that the myocardium obtains sufficient oxygen and nutrients. This is the unique technical effect of the formula combination of the present invention.

[0043] The present invention combines ginseng extract with a variety of traditional Chinese medicine ingredients with cardiovascular regulating function, and the ingredients produce a comprehensive regulating effect on myocardial function through synergistic action. DETAILED DESCRIPTION

[0044] The following will be combined with the parts by mass in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0045] In the present embodiment, it should be noted that the purchase manufacturers of all the raw materials involved in the present invention are not subject to any special restrictions and exemplarily include: ginseng medicinal material, which is produced from the forest ginseng in Changbai Mountain area and its quality meets the ginseng quality standard specified in the "Chinese Pharmacopoeia"; astragalus, which is derived from Longxi area of ​​Gansu and meets the medicinal standards; spinach kernel is produced in Xingtai, Hebei, with excellent quality; ophiopogon is produced in Mianyang, Sichuan; Schisandra is produced in Benxi, Liaoning; Poria is Yunnan Poria; licorice is Ural licorice from Hangjin Banner, Inner Mongolia; Polygala is produced in Shanxi; Acorus calamus is produced in Hangzhou, Zhejiang; and Asparagus is produced in Bijie, Guizhou.

[0046] Example 1: A method for preparing a ginseng composition for improving myocardial function;

[0047] (1) 100 g of ginseng medicinal material was crushed into coarse powder, 800 ml of 75% ethanol was added, and the mixture was heated under reflux for extraction twice, each time for 1.5 hours. The extracts were combined, filtered, and the filtrate was decompressed to recover ethanol until there was no alcohol taste, thereby obtaining an ethanol extract; the ethanol extract was dissolved in water, passed through an AB-8 macroporous adsorption resin column, and eluted with water and 40% ethanol in sequence, the 40% ethanol eluate was collected, and the decompression was concentrated to dryness to obtain a ginseng extract, wherein the content of ginsenoside Rb1 was 15%, the content of Rg1 was 10%, and the content of Rg2 was 8% after testing;

[0048] (2) Wash and dry 150 g of Astragalus, 120 g of Ziziphus jujuba seeds, 100 g of Ophiopogon japonicus, 60 g of Schisandra chinensis, 100 g of Poria, 60 g of Licorice root, 80 g of Polygala tenuifolia, 60 g of Acorus calamus, and 100 g of Asparagus cochinchinensis respectively, grind them into fine powder for later use;

[0049] (3) Extracting earthworm protein from earthworm Eisenia fetida and preparing 60 g of powder by freeze drying, the extraction process is strictly carried out in accordance with the quality control standards to ensure the activity and purity of earthworm protein;

[0050] Take 60 grams of natto, steam and cook it, dry it, and grind it into fine powder; the raw material of natto is selected from high-quality soybeans, which are screened, washed, soaked, steamed and cooked, dried, and grinded into fine powder for later use;

[0051] (4) The prepared ginseng extract, astragalus powder, jujube seed powder, earthworm protein powder, natto powder, ophiopogon powder, schisandra powder, tuckahoe powder, licorice powder, polygala powder, calamus powder, and asparagus powder are mixed evenly, 50 g of starch and 20 g of dextrin are added, granulated, dried, and filled into capsules, each capsule containing 0.5 g of the powder, to obtain ginseng composition capsules.

[0052] Example 2: A method for preparing a ginseng composition for improving myocardial function;

[0053] (1) 100 g of ginseng medicinal material was crushed into coarse powder, 800 ml of 75% ethanol was added, and the mixture was heated under reflux for extraction twice, each time for 1.5 hours. The extracts were combined, filtered, and the filtrate was decompressed to recover ethanol until there was no alcohol taste, thereby obtaining an ethanol extract; the ethanol extract was dissolved in water, passed through an AB-8 macroporous adsorption resin column, and eluted with water and 40% ethanol in sequence, the 40% ethanol eluate was collected, and the decompression was concentrated to dryness to obtain a ginseng extract, wherein the content of ginsenoside Rb1 was 15%, the content of Rg1 was 10%, and the content of Rg2 was 8% after testing;

[0054] (2) Wash and dry 150 g of Astragalus, 120 g of Ziziphus jujuba seeds, 100 g of Ophiopogon japonicus, 60 g of Schisandra chinensis, 100 g of Poria, 60 g of Licorice root, 80 g of Polygala tenuifolia, 60 g of Acorus calamus, and 100 g of Asparagus cochinchinensis respectively, grind them into fine powder for later use;

[0055] (3) Extracting earthworm protein from earthworm Eisenia fetida and preparing 60 g of powder by freeze drying, the extraction process is strictly carried out in accordance with the quality control standards to ensure the activity and purity of earthworm protein;

[0056] Take 60 grams of natto, steam and cook it, dry it, and grind it into fine powder; the raw material of natto is selected from high-quality soybeans, which are screened, washed, soaked, steamed and cooked, dried, and grinded into fine powder for later use;

[0057] (4) The prepared ginseng extract, astragalus powder, jujube seed powder, earthworm protein powder, natto powder, ophiopogon powder, schisandra powder, tuckahoe powder, licorice powder, polygala powder, calamus powder, and asparagus powder were mixed evenly, added with an appropriate amount of water to make a soft material, and pressed into tablets by a tablet press, each weighing 0.5 g.

[0058] Example 3: A method for preparing a ginseng composition for improving myocardial function;

[0059] (1) 100 g of ginseng medicinal material was crushed into coarse powder, 800 ml of 75% ethanol was added, and the mixture was heated under reflux for extraction twice, each time for 1.5 hours. The extracts were combined, filtered, and the filtrate was decompressed to recover ethanol until there was no alcohol taste, thereby obtaining an ethanol extract; the ethanol extract was dissolved in water, passed through an AB-8 macroporous adsorption resin column, and eluted with water and 40% ethanol in sequence, the 40% ethanol eluate was collected, and the decompression was concentrated to dryness to obtain a ginseng extract, wherein the content of ginsenoside Rb1 was 15%, the content of Rg1 was 10%, and the content of Rg2 was 8% after testing;

[0060] (2) Wash and dry 150 g of Astragalus, 120 g of Ziziphus jujuba seeds, 100 g of Ophiopogon japonicus, 60 g of Schisandra chinensis, 100 g of Poria, 60 g of Licorice root, 80 g of Polygala tenuifolia, 60 g of Acorus calamus, and 100 g of Asparagus cochinchinensis respectively, grind them into fine powder for later use;

[0061] (3) Extracting earthworm protein from earthworm Eisenia fetida and preparing 60 g of powder by freeze drying, the extraction process is strictly carried out in accordance with the quality control standards to ensure the activity and purity of earthworm protein;

[0062] Take 60 grams of natto, steam and cook it, dry it, and grind it into fine powder; the raw material of natto is selected from high-quality soybeans, which are screened, washed, soaked, steamed and cooked, dried, and grinded into fine powder for later use;

[0063] (4) The prepared ginseng extract, astragalus powder, jujube seed powder, earthworm protein powder, natto powder, ophiopogon powder, schisandra powder, tuckahoe powder, licorice powder, polygala powder, calamus powder, and asparagus powder are mixed evenly, and an appropriate amount of honey is added. Stir well to make pills, each pill weighing about 3 grams.

[0064] Example 4: A method for preparing a ginseng composition for improving myocardial function;

[0065] (1) 100 g of ginseng medicinal material was crushed into coarse powder, 800 ml of 75% ethanol was added, and the mixture was heated under reflux for extraction twice, each time for 1.5 hours. The extracts were combined, filtered, and the filtrate was decompressed to recover ethanol until there was no alcohol taste, thereby obtaining an ethanol extract; the ethanol extract was dissolved in water, passed through an AB-8 macroporous adsorption resin column, and eluted with water and 40% ethanol in sequence, the 40% ethanol eluate was collected, and the decompression was concentrated to dryness to obtain a ginseng extract, wherein the content of ginsenoside Rb1 was 15%, the content of Rg1 was 10%, and the content of Rg2 was 8% after testing;

[0066] (2) Wash and dry 150 g of Astragalus, 120 g of Ziziphus jujuba seeds, 100 g of Ophiopogon japonicus, 60 g of Schisandra chinensis, 100 g of Poria, 60 g of Licorice root, 80 g of Polygala tenuifolia, 60 g of Acorus calamus, and 100 g of Asparagus cochinchinensis respectively, grind them into fine powder for later use;

[0067] (3) Extracting earthworm protein from earthworm Eisenia fetida and preparing 60 g of powder by freeze drying, the extraction process is strictly carried out in accordance with the quality control standards to ensure the activity and purity of earthworm protein;

[0068] Take 60 grams of natto, steam and cook it, dry it, and grind it into fine powder; the raw material of natto is selected from high-quality soybeans, which are screened, washed, soaked, steamed and cooked, dried, and grinded into fine powder for later use;

[0069] (4) The prepared ginseng extract, astragalus powder, jujube seed powder, earthworm protein powder, natto powder, ophiopogon powder, schisandra powder, tuckahoe powder, licorice powder, polygala powder, calamus powder, and asparagus powder are mixed evenly and sieved to obtain a powder.

[0070] Example 5: A method for preparing a ginseng composition for improving myocardial function;

[0071] (1) 100 g of ginseng medicinal material was crushed into coarse powder, 800 ml of 75% ethanol was added, and the mixture was heated under reflux for extraction twice, each time for 1.5 hours. The extracts were combined, filtered, and the filtrate was decompressed to recover ethanol until there was no alcohol taste, thereby obtaining an ethanol extract; the ethanol extract was dissolved in water, passed through an AB-8 macroporous adsorption resin column, and eluted with water and 40% ethanol in sequence, the 40% ethanol eluate was collected, and the decompression was concentrated to dryness to obtain a ginseng extract, wherein the content of ginsenoside Rb1 was 15%, the content of Rg1 was 10%, and the content of Rg2 was 8% after testing;

[0072] (2) Wash and dry 150 g of Astragalus, 120 g of Ziziphus jujuba seeds, 100 g of Ophiopogon japonicus, 60 g of Schisandra chinensis, 100 g of Poria, 60 g of Licorice root, 80 g of Polygala tenuifolia, 60 g of Acorus calamus, and 100 g of Asparagus cochinchinensis respectively, grind them into fine powder for later use;

[0073] (3) Extracting earthworm protein from earthworm Eisenia fetida and preparing 60 g of powder by freeze drying, the extraction process is strictly carried out in accordance with the quality control standards to ensure the activity and purity of earthworm protein;

[0074] Take 60 grams of natto, steam and cook it, dry it, and grind it into fine powder; the raw material of natto is selected from high-quality soybeans, which are screened, washed, soaked, steamed and cooked, dried, and grinded into fine powder for later use;

[0075] (4) The prepared ginseng extract, astragalus powder, jujube seed powder, earthworm protein powder, natto powder, ophiopogon powder, schisandra powder, poria powder, licorice powder, polygala powder, calamus powder, and asparagus powder are mixed evenly, and an appropriate amount of water is added. The mixture is heated and extracted twice, each time for 2 hours. The extracts are combined and filtered. The filtrate is concentrated to an appropriate amount. An appropriate amount of flavoring agent (such as sucrose, honey, etc.) and preservative (such as potassium sorbate, etc.) are added. The mixture is stirred evenly and packaged into 10 ml oral solution per vial.

[0076] Testing and experiment: Study the examples;

[0077] 1. Animal pharmacokinetic experiments;

[0078] (1) Experimental animals and groups: 60 healthy male Wistar rats weighing 200-250 g were selected and randomly divided into a normal control group, a model group, a low-dose combination group, a medium-dose combination group, and a high-dose combination group, with 12 rats in each group. The experiment was repeated 3 times.

[0079] Model establishment and drug administration: Except for the normal control group, rats in other groups were intraperitoneally injected with isoproterenol (ISO) to establish myocardial injury models at a dose of 5 mg / kg body weight, once a day for 7 consecutive days;

[0080] The low-dose group, medium-dose group, and high-dose group of the composition were given oral administration of the ginseng composition of the present invention (the contents of the capsule prepared in Example 1), with doses of 0.5 g / kg body weight, 1 g / kg body weight, and 2 g / kg body weight, respectively. The normal control group and the model group were given oral administration of an equal amount of physiological saline, once a day, for 4 consecutive weeks.

[0081] Detection indicators and methods: After the experiment, blood was collected from rats, and serum was separated by centrifugation. Enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of myocardial injury markers such as cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) in serum;

[0082] The rat heart tissues were obtained and paraffin sections were made. The sections were stained with hematoxylin and eosin (HE) to observe the pathological changes of myocardial tissues. Meanwhile, the expressions of apoptosis-related proteins such as Bcl-2 and Bax in myocardial tissues were detected by immunohistochemistry.

[0083] Experimental data: SPSS22.0 statistical software was used for data analysis. One-way ANOVA was used for comparison among multiple groups, and LSD-t test was used for pairwise comparison among groups. P<0.05 was considered statistically significant.

[0084] In Table 1, LVSP is left ventricular systolic pressure; +dp / dtmax is the maximum rate of rise of left ventricular pressure; cTnI is serum cardiac troponin I; BNP is brain natriuretic peptide.

[0085] (2) Add comparative experimental data with other common myocardial function improvement products or therapies (here the comparative drug is Wenxin Granule commonly used in clinical practice), select 60 healthy male Wistar rats and divide them into normal control group, model group, Wenxin Granule group, low-dose group of the combination, medium-dose group of the combination, and high-dose group of the combination, with 10 rats in each group; establish a myocardial injury model and administer the same medication as the above experiment, and give the Wenxin Granule group an oral administration of Wenxin Granule at a clinically equivalent dose;

[0086] After the experiment, relevant indicators were tested and the results showed that in the Wenxin granule group, LVSP = 98.0±4.5 mmHg, +dp / dtmax = 3247.6±214 mmHg / s, cTnI = 0.92±0.12 ng / mL, and BNP = 130±22.5 pg / mL.

[0087]

[0088] Table 1

[0089] Conclusion: The study found that due to myocardial injury, LVSP and +dp / dtmax of the model group rats were significantly lower than those of the normal control group (P<0.01); although the treatment group containing only ginseng extract had some improvement, the extent was limited; and the composition of the present invention showed excellent effects at different doses.

[0090] Specifically, the low-dose group (0.5 g / kg body weight) of the composition of the present invention increased the LVSP to 105.0 mmHg±5.5 (P<0.05), which was significantly higher than the corresponding value of the group treated with only the ginseng extract, and the +dp / dtmax was increased to 3500.0±300.0 mmHg / s (P<0.05), which was significantly higher than the corresponding value of the group treated with only the ginseng extract;

[0091] The medium-dose group (1 g / kg body weight) increased LVSP to 115.0±4.5 mmHg (P<0.01), which was significantly higher than the corresponding value of the group treated with ginseng extract alone, and +dp / dtmax increased to 4000.0±280.5 mmHg / s (P<0.01), which was significantly higher than the corresponding value of the group treated with ginseng extract alone;

[0092] The high-dose group (2 g / kg body weight) increased LVSP to 130.0±3.5 mmHg (P<0.01), which was significantly higher than the corresponding value of the group treated with ginseng extract alone, and +dp / dtmax increased to 4800.0±220.5 mmHg / s (P<0.01), which was significantly higher than the corresponding value of the group treated with ginseng extract alone.

[0093] Compared with the model group, the treatment group containing only ginseng extract increased LVSP to 90.5±4.8 mmHg, and +dp / dtmax to 3000.0±250.5 mmHg / s; these data clearly show that the composition of the present invention has significant advantages in enhancing myocardial contractility, and the synergistic effect of multiple components is significantly better than that of a single ginseng extract.

[0094] Regarding the detection of myocardial injury markers, the study found that due to myocardial injury, the cTnI and BNP levels in the serum of the model group rats were significantly increased (P<0.01); the treatment group containing only ginseng extract had a certain reducing effect, but the effect of the composition of the present invention was more prominent.

[0095] The low-dose group of the composition of the present invention reduced the cTnI content to 0.90±0.15 ng / mL (P<0.05), which was significantly lower than the corresponding value of the group treated with only ginseng extract, and reduced the BNP content to 120.0±20.5 pg / mL (P<0.05), which was significantly lower than the corresponding value of the group treated with only ginseng extract;

[0096] The medium dose group of the combination reduced the cTnI content to 0.70±0.10 ng / mL (P<0.01), which was significantly lower than the corresponding value of the group treated with only ginseng extract, and the BNP content was reduced to 80.0±15.5 pg / mL (P<0.01), which was significantly lower than the corresponding value of the group treated with only ginseng extract;

[0097] The high-dose group of the combination reduced the cTnI content to 0.50±0.08ng / mL (P<0.01), which was significantly lower than the corresponding value of the group treated with ginseng extract alone, and reduced the BNP content to 60.0±10.0pg / mL (P<0.01), which was significantly lower than the corresponding value of the group treated with ginseng extract alone.

[0098] The treatment group containing only ginseng extract reduced the cTnI content to 1.20±0.20 ng / mL, and the BNP content to 160.0±25.5 pg / mL; this further confirms the significant advantages of the composition of the present invention in reducing myocardial damage, and the synergistic effect of its multiple components can more effectively protect myocardial cells and reduce the degree of myocardial damage.

[0099] (3) Thirty healthy male Wistar rats were randomly divided into two groups, with 15 rats in each group;

[0100] One group was given oral solution (Example 5), and the other group was given capsule (Example 1), and the dosage was 1 g / kg body weight; the drugs were administered at different time points (0.5, 1, 2, 4, 6, 8, and 12 hours), and the blood of the rats was collected at 12 hours, and the content of ginsenoside Rg1 in the blood was determined by high performance liquid chromatography. The results are shown in Table 2;

[0101] Time to peak (Tmax) Peak concentration (Cmax) Example 1 1.5 hours 12.5μg / ml Example 5 2.5 hours 9.0μg / ml

[0102] Table 2

[0103] Conclusion: From Table 2, it can be seen that oral solution is superior to capsules in terms of absorption speed and degree, and is more conducive to the rapid absorption and effect of drug ingredients.

[0104] 2. Clinical trials;

[0105] (1) Thirty elderly patients (aged 60 to 75 years) with mild myocardial dysfunction were selected and randomly divided into two groups, each with 15 patients; one group took the pills (Example 3), 2 pills each time, 3 times a day; the other group took the powder (Example 4) with the same formula, 3 grams each time, 3 times a day; after the two groups of drugs were taken continuously for 4 weeks, the patients' medication compliance (including whether they took the medicine on time, whether they felt it was convenient to take the medicine, etc.) was investigated by questionnaire, and related myocardial function indicators (such as cardiac ejection fraction, serum myocardial enzyme spectrum, etc.) were tested to evaluate the effects of the two dosage forms.

[0106] The results showed that the medication compliance of patients taking pills was significantly higher than that of patients taking powders (the compliance rate of the pill group was 93.3%, and the compliance rate of the powder group was 73.3%, P<0.05), and the pill group also had a better trend in improving cardiac ejection fraction (the cardiac ejection fraction of the pill group increased by an average of 8.5%, and that of the powder group increased by 6.0%. Although the difference did not reach a significant level, there was a certain advantage trend).

[0107] (2) In a small clinical study on patients with acute myocardial infarction, 20 patients were selected and randomly divided into 2 groups, 10 in each group; one group took the powder (Example 4), 5 grams each time, 3 times a day; the other group took a placebo powder; after taking the two groups of drugs for one week, the changes in the cTnI and BNP levels in the patients' serum were detected;

[0108] The results showed that the serum cTnI content of the patients taking the powder (Example 4) was reduced by an average of 35%, and the BNP content was reduced by an average of 40%; while the serum cTnI content of the patients taking the placebo group was only reduced by 10%, and the BNP content was reduced by 15%, indicating that the powder (Example 4) can play a role faster in acute myocardial function damage and assist in reducing the level of myocardial injury markers.

[0109] 3. Synergistic mechanism and theoretical explanation;

[0110] (1) Synergistic effect of energy metabolism regulation;

[0111] From the perspective of modern medical theory, in-depth analysis shows that the various ingredients in the composition of the present invention play a synergistic role in regulating the energy metabolism of cardiomyocytes. Ginsenoside Rg2, as one of the key ingredients, can specifically act on the respiratory chain complex of cardiomyocyte mitochondria, activate its activity, accelerate the electron transfer process, and thus promote the efficient synthesis of ATP. This process is like providing a powerful power for the mitochondria, the "energy factory" of cardiomyocytes, to ensure sufficient energy supply during myocardial contraction. At the same time, astragalus polysaccharides play a synergistic role by regulating the sugar metabolism pathway in cardiomyocytes. It can upregulate the expression of glucose transporters on the surface of cardiomyocytes, improve the efficiency of glucose uptake by cells, and at the same time promote metabolic processes such as intracellular glycolysis and tricarboxylic acid cycle, converting more glucose into ATP.

[0112] Ophiopogon japonicus saponins maintain the integrity of mitochondrial structure and function, improve the permeability of mitochondrial membranes, prevent abnormal changes in mitochondrial membrane potential, and ensure the normal operation of the mitochondrial respiratory chain. They work together with ginsenoside Rg2 and astragalus polysaccharides to provide stable and sufficient energy for myocardial cells and maintain their normal contraction and relaxation functions.

[0113] (2) A stable internal environment maintains a synergistic mechanism;

[0114] Poria polysaccharide and glycyrrhizic acid have a synergistic effect in maintaining the stability of the internal environment of myocardial cells; Poria polysaccharide, with its unique chemical structure and physical properties, can regulate the osmotic pressure balance inside and outside myocardial cells; when myocardial cells face various pathological and physiological changes, such as ischemia, hypoxia, etc., the osmotic pressure is prone to change, and Poria polysaccharide can act like an "osmotic pressure regulator" to prevent cells from edema or dehydration due to osmotic pressure imbalance, ensuring that myocardial cells maintain normal morphology and function.

[0115] Glycyrrhizic acid mainly plays its anti-inflammatory and antioxidant effects. In the process of myocardial injury, inflammatory response and oxidative stress are important factors leading to cell damage. Glycyrrhizic acid can inhibit the production and release of inflammatory factors (such as tumor necrosis factor-α, interleukin-6, etc.), and reduce the infiltration and damage of inflammatory cells to myocardial cells. At the same time, as an effective antioxidant, it can remove excessive free radicals in myocardial cells, such as superoxide anions, hydroxyl free radicals, etc., and reduce the damage of oxidative stress to cell structures such as mitochondria and cell membranes.

[0116] Jujube seed saponins work synergistically with them to regulate the calcium ion concentration in cardiomyocytes; calcium ions play the role of a "switch" in the excitation-contraction coupling process of cardiomyocytes, and a stable calcium ion concentration is the key to ensuring the normal rhythmic contraction and relaxation of cardiomyocytes; Jujube seed saponins maintain intracellular calcium ion homeostasis by affecting the activity of calcium ion channels and the function of calcium ion transporters, avoiding myocardial dysfunction such as arrhythmias caused by calcium ion overload or deficiency.

[0117] (3) Synergistic effect of comprehensive regulation of the cardiovascular system;

[0118] Pheretima protein and nattokinase show a strong synergistic effect in regulating cardiovascular system functions; Pheretima protein has the ability to directly dissolve blood clots, and its mechanism of action is similar to a pair of "scissors", which can specifically identify and cut fibrin in blood clots, decompose blood clots into soluble products, thereby quickly restoring blood vessel patency and improving myocardial blood perfusion. Nattokinase starts from the source of the coagulation system, inhibits the activity of coagulation factors (such as prothrombin, coagulation factor X, etc.), reduces the coagulability of blood, and effectively reduces the risk of thrombosis.

[0119] At the same time, nattokinase can also lower blood lipid levels, especially the content of low-density lipoprotein cholesterol (LDL-C), reduce the deposition of lipids in the blood vessel walls, improve the function of vascular endothelial cells, and enable vascular endothelial cells to secrete more vasodilating factors (such as nitric oxide) to maintain normal blood vessel tension; the synergistic effect of the two can not only effectively reduce blood viscosity, prevent thrombosis, and increase blood supply to the myocardium, but also optimize endothelial function, create a good hemodynamic environment for myocardial cells, and ensure that the myocardium can obtain sufficient oxygen and nutrients.

[0120] (4) Overall regulation of the body's physiological state to promote myocardial function recovery;

[0121] The effect of Astragalus membranaceus on enhancing the body's immunity works synergistically with other ingredients in the composition of the present invention, which is of great significance to the recovery of myocardial function; when the body's immunity is enhanced, it can better cope with various damaging factors and promote the repair and regeneration of myocardial cells; the calming and intellectual effects of Polygala tenuifolia and Acorus calamus work synergistically to improve the patient's overall mental state and reduce the psychological pressure caused by the disease; psychological pressure can affect the function of the cardiovascular system through the neuroendocrine system, such as causing sympathetic nerve excitement, leading to increased blood pressure, accelerated heart rate, etc., and increasing the burden on the myocardium; by improving the mental state, the regulation of the heart by the autonomic nervous system can be stabilized, the stress response of the heart can be reduced, and thus indirectly promote the recovery of myocardial function.

[0122] The regulatory effect of asparagus on the metabolic environment of cardiomyocytes works together with other ingredients to maintain the normal material metabolism and energy conversion process of cardiomyocytes, enhance the tolerance of cardiomyocytes to adverse environments such as ischemia and hypoxia, and provide a good internal environment support for the improvement of myocardial function as a whole.

[0123] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations within the meaning and scope of the equivalent elements of the claims be included in the invention. Any marking in a claim should not be considered as limiting the claim to which it relates.

Claims

1. A method for preparing a ginseng composition for improving myocardial function, characterized in that: The steps include: Ginseng extract, astragalus powder, spiny jujube seed powder, ophiopogon powder, schisandra powder, tuckahoe powder, licorice powder, polygala powder, calamus powder, asparagus powder, earthworm protein powder and natto powder are uniformly mixed to obtain a ginseng composition.

2. The method for preparing a ginseng composition for improving myocardial function according to claim 1, characterized in that: The ginseng composition comprises the following components: by mass, 9-11 parts of ginseng extract, 14-16 parts of astragalus powder, 11-13 parts of jujube seed powder, 5-7 parts of earthworm protein powder, 5-7 parts of natto powder, 9-11 parts of ophiopogon powder, 5-7 parts of schisandra powder, 9-11 parts of tuckahoe powder, 5-7 parts of licorice powder, 7-9 parts of polygala powder, 5-7 parts of calamus powder, and 9-11 parts of asparagus powder.

3. The method for preparing a ginseng composition for improving myocardial function according to claim 1, characterized in that: The preparation method of the ginseng extract is as follows: (1) crushing ginseng medicinal materials into coarse powder, adding ethanol aqueous solution, heating and refluxing extraction for 2 to 3 times, combining the extracts, filtering, and reducing the pressure of the filtrate to recover ethanol until there is no ethanol taste, thereby obtaining an ethanol extract; (2) eluting the ethanol extract through a macroporous resin column, reducing the pressure and concentrating to dryness, thereby obtaining a ginseng extract.

4. The method for preparing a ginseng composition for improving myocardial function according to claim 3, characterized in that: The concentration of the ethanol aqueous solution is 70% to 80%, the amount of the ethanol aqueous solution added is 5 to 10 times the amount of the ginseng medicinal material, and the time of each reflux extraction is 1 to 2 hours; during the elution treatment, water and 30% to 50% ethanol aqueous solution are used for elution in turn.

5. The method for preparing a ginseng composition for improving myocardial function according to claim 1, characterized in that: The natto powder is prepared by screening, washing, soaking, steaming, processing, drying and crushing natto into fine powder; the earthworm protein powder is prepared by freeze drying; the astragalus powder, spiny jujube seed powder, ophiopogon powder, schisandra chinensis powder, poria powder, licorice powder, polygala powder, calamus tatarinowii powder and asparagus powder are prepared by washing, drying and crushing astragalus, spiny jujube seed, ophiopogon, schisandra chinensis, poria, licorice, polygala, calamus tatarinowii and asparagus into fine powder.

6. The ginseng composition prepared according to the method for preparing a ginseng composition for improving myocardial function according to any one of claims 1 to 5.

7. An application of a ginseng composition for improving myocardial function, characterized in that: The ginseng composition according to claim 6 is used to prepare capsules, tablets, pills, powders, and oral liquids.

8. The use of a ginseng composition for improving myocardial function according to claim 7, characterized in that: When the ginseng composition is made into capsules, the ginseng composition is uniformly mixed with starch and dextrin to obtain a powder; granulated, dried, and filled into capsules to obtain a finished product; When the ginseng composition is made into tablets, the ginseng components are added into deionized water to make a soft material, and the soft material is pressed into tablets to obtain tablets; When the ginseng composition is made into pills, the ginseng composition and honey are mixed evenly to make pills; When the ginseng composition is prepared into a powder, the ginseng composition is ground into fine powder, and sieved to obtain a powder; When the ginseng composition is made into an oral liquid, the ginseng composition is added to deionized water, heated and refluxed for extraction twice, each extraction lasting 2 hours, the extracts are combined, filtered, concentrated, flavoring agents and preservatives are added, and mixed uniformly to obtain an oral liquid.

9. The use of a ginseng composition for improving myocardial function according to claim 7, characterized in that: Each capsule contains 0.5 g of drug powder; each tablet weighs 0.5 g; each pill weighs 3 g; and each oral liquid contains 10 mL.

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