Composition as well as preparation method and application thereof

Abstract

The invention relates to the technical field of medicine preparation, and particularly provides a composition as well as a preparation method and application thereof. The composition disclosed by the invention comprises the following components: sorbitol, lucid ganoderma, sea-buckthorn powder, astragalus membranaceus, Chinese wolfberry fruit powder, red yeast rice, D-mannitol, folium cortex eucommiae, fructus gardeniae, rhizoma gastrodiae and magnesium stearate. The synergistic effect of all the components of the composition can achieve the effects of protecting myocardial cells, relieving inflammation symptoms and protecting the cardiovascular system, and a product suitable for myocardial protection can be provided.

Description

Technical Field

[0001] The present invention relates to the technical field of drug preparation, and particularly relates to a composition, a preparation method and a use thereof. Background Art

[0002] Among the numerous cardiovascular diseases that pose a serious threat to human health, the situation of coronary heart disease is particularly severe. The number of its patients continues to rise and the treatment situation remains not optimistic. The current main treatment methods for coronary heart disease, such as intracoronary thrombolysis and coronary artery bypass grafting, although relieve the condition to a certain extent, the problem of serious damage to the myocardial structure caused by myocardial ischemia and reperfusion has not been effectively solved. The continuous expansion of the necrosis range always looms over the prognosis and recovery of coronary heart disease patients like a cloud, greatly affecting their quality of life and life health.

[0003] Although there are various chemical drugs on the current market for the treatment of coronary heart disease, these drugs often inevitably have many adverse reactions. For example, some drugs may cause varying degrees of damage to important organs such as the liver and kidneys, resulting in abnormal liver and kidney function indicators; some drugs may cause gastrointestinal discomfort, such as nausea, vomiting, diarrhea and other symptoms, which not only bring additional physical pain to patients, but also reduce the medication compliance of patients to a certain extent, making the urgent need for better treatment drugs among the majority of patients more and more urgent. In this context, actively developing a new product suitable for myocardial protection has become an urgent task. Summary of the Invention

[0004] In view of this, the present invention aims to provide a composition to provide a product suitable for myocardial protection.

[0005] To achieve the above object, the technical solution of the present invention is realized as follows:

[0006] A composition, the components of the composition include sorbitol, Ganoderma lucidum, seabuckthorn powder, Astragalus membranaceus, wolfberry powder, red yeast rice, D-mannitol, Eucommia ulmoides leaves, Gardenia jasminoides Ellis, Gastrodia elata Blume, magnesium stearate.

[0007] Further, each component of the composition includes, by weight, 10 parts to 20 parts of sorbitol, 10 parts to 18 parts of Ganoderma lucidum, 10 parts to 15 parts of seabuckthorn powder, 10 parts to 15 parts of Astragalus membranaceus, 7 parts to 15 parts of wolfberry powder, 7 parts to 15 parts of red yeast rice, 2 parts to 8 parts of D-mannitol, 2 parts to 8 parts of Eucommia ulmoides leaves, 3 parts to 9 parts of Gardenia jasminoides Ellis, 1 part to 5 parts of Gastrodia elata Blume, 0.1 part to 2 parts of magnesium stearate.

[0008] Compared with the prior art, the present invention has the following advantages:

[0009] The composition of the present invention, through its component composition, its main components Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, Gardenia jasminoides, sea buckthorn powder, wolfberry powder, and red yeast rice all have anti-inflammatory and antioxidant effects.

[0010] Among them, the triterpenoid compounds and polysaccharides in Ganoderma lucidum can scavenge excessive free radicals in the body, reduce oxidative damage, and can reduce the damage of inflammatory response to blood vessel walls and myocardial tissues by inhibiting the activation of inflammatory cells and the release of inflammatory mediators. At the same time, astragaloside, total saponins, and total flavonoids contained in Astragalus membranaceus powder can reduce the activity of Na + -K + -ATPase in myocardial ischemia-reperfusion myocardial tissues, and have a protective effect on the ultrastructural changes of myocardial cells and mitochondria caused by hypoxia.

[0011] In addition, Gastrodia elata polysaccharide in Gastrodia elata has the effects of enhancing the body's non-specific immunity, cellular immunity and anti-inflammatory effects, as well as inhibiting platelet aggregation and protecting myocardial cells.

[0012] As can be seen from the above introduction, Ganoderma lucidum, Astragalus membranaceus powder, and Gastrodia elata can protect myocardial cells. In addition, the components sea buckthorn, wolfberry powder, red yeast rice, and Eucommia ulmoides leaves in the composition of the present invention have the effects of regulating immunity and reducing blood lipids, and have a protective effect on the cardiovascular system. The synergistic effect of each component of the present invention can play a role in protecting myocardial cells, reducing inflammatory symptoms, and protecting the cardiovascular system.

[0013] At the same time, the present invention also proposes a preparation method of the above composition, and the preparation method includes:

[0014] Crush and screen the sorbitol, Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides respectively;

[0015] Mix the sieved sorbitol, Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, Gardenia jasminoides with the sea buckthorn powder, wolfberry powder, red yeast rice, D-mannitol and binder to make a wet soft material;

[0016] Make the wet soft material into wet granules, and dry the wet granules to make dry granules;

[0017] Mix the dry granules and magnesium stearate to obtain a mixed material, and press the mixed material into tablets to obtain the composition.

[0018] Furthermore, the sorbitol is sieved through a 60-mesh sieve; and / or,

[0019] The Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides are all sieved through an 80-mesh sieve.

[0020] Further, the adhesive comprises ethanol with a volume fraction of 90%.

[0021] Further, the wet soft material is sieved through a 20-mesh sieve to form the wet granules.

[0022] Further, the moisture content of the dry granules is ≤ 5.0%.

[0023] In addition, the present invention also provides a use of the above composition, and the composition is used for preparing functional foods, health products or pharmaceuticals.

[0024] Further, the functional food is used for myocardial cell protection and prevention of cardiovascular diseases; and / or,

[0025] the health product is used for myocardial cell protection and prevention of cardiovascular diseases; and / or,

[0026] the pharmaceutical is used for myocardial cell protection and prevention of cardiovascular diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The drawings constituting a part of the present invention are used to provide a further understanding of the present invention. The schematic embodiments and descriptions thereof of the present invention are used to explain the present invention and do not constitute an improper limitation to the present invention. In the drawings:

[0028] Figure 1 is a flowchart of the preparation method of the composition of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0029] It should be noted that, without conflict, the embodiments in the present invention and the features in the embodiments can be combined with each other.

[0030] For those conditions not specified in the present invention, they can be carried out according to conventional conditions or the conditions recommended by the manufacturer of the equipment used. For those reagents or instruments without indicating the manufacturer, they can be all conventional products obtained by purchasing through the market. For the technical means or process methods involved, if not specifying the specific conditions, they can be carried out according to the existing methods in the field.

[0031] This embodiment relates to a composition, in order to provide a product suitable for myocardial protection.

[0032] In the overall design, the components of the composition in this embodiment include Ganoderma lucidum, seabuckthorn powder, Astragalus membranaceus, wolfberry powder, red yeast rice, Eucommia ulmoides leaves, Gardenia jasminoides Ellis, Gastrodia elata Blume, sorbitol, D-mannitol, magnesium stearate.

[0033] Specifically, the effective components of Ganoderma lucidum in the above components are Ganoderma triterpenoids and polysaccharides, which have the effects of regulating blood lipid, antioxidation, improving hemorheology, protecting myocardial cells, anti-inflammation, etc. At the same time, the triterpenoids and polysaccharides in Ganoderma lucidum can scavenge excessive free radicals in the body, reduce oxidative damage, and can reduce the damage of inflammatory response to blood vessel walls and myocardial tissues by inhibiting the activation of inflammatory cells and the release of inflammatory mediators.

[0034] The seabuckthorn powder in the components is rich in various vitamins, minerals and bioactive substances. The active substances such as flavonoids, other polyphenolic compounds, β-sitosterol, unsaturated fatty acids and betaine contained therein can reduce cholesterol and triglycerides in the blood. At the same time, the above active substances can also reduce low-density lipoprotein and blood viscosity, inhibit platelet aggregation and prevent atherosclerosis. In addition, the above active substances can also prevent the increase in blood lipid caused by high-fat diet, increase coronary blood flow, reduce myocardial oxygen consumption, enhance heart function, etc.

[0035] The astragaloside, total saponins and total flavonoids contained in the astragalus powder in the components can reduce the activity of Na + -K + -ATPase in myocardial ischemia-reperfusion myocardial tissue, and have a protective effect on the ultrastructural changes of myocardial cells and mitochondria caused by hypoxia. At the same time, it can also increase the content of lactate dehydrogenase and succinate dehydrogenase in human myocardial cells to varying degrees, and reduce the consumption of ATP during reperfusion, ensuring the functions of cell membrane calcium pump and sarcoplasmic reticulum calcium pump, and reducing intracellular Ca + thereby reducing calcium overload. Therefore, astragalus has the functions of improving myocardial contractility, protecting myocardial cells and regulating immunity.

[0036] The wolfberry powder in the components contains rich nutritional components such as wolfberry polysaccharides, wolfberry flavonoids, carotenoids, etc. Among them, wolfberry polysaccharides have a low sweetness, can lower blood sugar, and at the same time have the effects of enhancing immunity, antioxidation, etc. The wolfberry flavonoids contained in wolfberry powder contain PAF anticoagulant factors that can inhibit and improve cardiovascular and cerebrovascular diseases. At the same time, the betaine contained in wolfberry can participate in the methionine cycle and lecithin synthesis, and has the effects of antioxidation and enhancing immunity, which helps to reduce oxidative stress damage and has a certain protective effect on the cardiovascular system.

[0037] The red yeast rice in the components contains ingredients such as Monacolin K, which can inhibit the key enzymes in the cholesterol synthesis process, reduce the levels of total cholesterol and low-density lipoprotein cholesterol in the blood, increase the level of high-density lipoprotein cholesterol, help regulate blood lipid, reduce the formation of atherosclerotic plaques, and thus play a positive role in the prevention and treatment of coronary heart disease. In addition, the pigments and other active components in red yeast rice also have the effects of antioxidation, antibacterial and anti-inflammatory, etc., which helps to reduce vascular inflammatory response and protect the cardiovascular system.

[0038] The Eucommia leaves in the ingredients contain lignan compounds, the main component of which is pinoresinol diglucoside, which has the effect of lowering blood pressure. At the same time, the Eucommia leaves also contain flavonoids, the main ones being quercetin, quercetin glycoside, astragalus glycoside, kaempferol, isoquercetin, rutin, and terrestrin, which have the effects of antioxidant and prevention of cardiovascular diseases.

[0039] The main active ingredients of Gardenia in the components include iridoids, organic acids and gardenia yellow. Among them, iridoid compounds have antifungal effects, while caffeoylquinic acid and dicaffeoylquinic acid in organic acid compounds have the effect of scavenging free radicals. In addition, gardenia yellow can reduce the bilirubin and cholesterol levels in the blood. Therefore, Gardenia has the effects of purging fire and relieving restlessness, clearing heat and removing dampness, cooling blood and detoxifying. In this embodiment, Gardenia is used as an anti-inflammatory component to improve vascular inflammation.

[0040] The gastrodia phenols contained in the components of Gastrodia elata can protect myocardial cells after ischemia. Gastrodia phenols protect ischemic myocardial damage by enhancing the clearance of myocardial infarction cells, downregulating inflammatory factors, promoting cardiovascular generation and anti-apoptosis. At the same time, gastrodia phenols also have anti-coagulant effects and can inhibit the formation of blood clots by interfering with the point-like interactions between fibrin molecules.

[0041] The sorbitol and D-mannitol in the ingredients are used as fillers and sweeteners to adjust the taste and texture of the composition of this example.

[0042] The magnesium stearate in the component is a pharmaceutical excipient and is used as a lubricant in the composition of this embodiment to make the composition easier to shape and process during the preparation process.

[0043] Based on the above introduction to each component, the main components of the composition of this embodiment, ganoderma lucidum, seabuckthorn powder, astragalus, wolfberry powder, red yeast rice, eucommia leaf, gardenia, and gastrodia all have anti-inflammatory and antioxidant effects, among which ganoderma lucidum, astragalus powder and gastrodia can protect myocardial cells, seabuckthorn, wolfberry powder, red yeast rice and eucommia leaf can regulate immunity, reduce blood lipids, and have a protective effect on cardiovascular. Therefore, the synergistic effect of the components of the composition of this embodiment can protect myocardial cells, alleviate inflammatory symptoms, and protect the cardiovascular system.

[0044] It should be noted that, based on the above overall component composition, further, in the specific implementation, the components of the composition of this embodiment are measured by weight, for example, they can be 10 to 20 parts of sorbitol, 10 to 18 parts of Ganoderma lucidum, 10 to 15 parts of sea buckthorn powder, 10 to 15 parts of Astragalus, 7 to 15 parts of wolfberry powder, 7 to 15 parts of red yeast rice, 2 to 8 parts of D-mannitol, 2 to 8 parts of Eucommia ulmoides leaves, 3 to 9 parts of Gardenia jasminoides, 1 to 5 parts of Gastrodia elata, and 0.1 to 2 parts of magnesium stearate.

[0045] In this embodiment, based on the above introduction of the composition of the composition, in specific implementation, an exemplary preparation method of the above composition is combined with Figure 1 As shown, it specifically includes the following steps:

[0046] Step S1: Crush and sieve sorbitol, Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides respectively.

[0047] In step S1 above, when sieving sorbitol, as a preferred implementation form, for example, sorbitol can be sieved through a 60-mesh sieve.

[0048] Meanwhile, in step S1 above, when sieving Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides, as a preferred implementation form, for example, Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides can be sieved through an 80-mesh sieve.

[0049] Step S2: Mix the sieved sorbitol, Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, Gardenia jasminoides with sea buckthorn powder, wolfberry powder, red yeast rice, D-mannitol and a binder to make a wet soft material.

[0050] The binder used in step S2 above is ethanol with a volume fraction of 90%.

[0051] Step S3: Make the wet soft material into wet granules and dry the wet granules to make dry granules.

[0052] In step S3 above, when making the wet soft material into wet granules, as a preferred implementation form, for example, the wet soft material can be sieved through a 20-mesh sieve to make wet granules.

[0053] Among them, when the wet soft material forms granules through the sieve, it should be noted that when the granules fall from the sieve holes in a long strip shape, it indicates that the wet soft material is too wet. On the contrary, if the wet soft material is in a powdery state after passing through the sieve holes, it indicates that the wet soft material is too dry. Therefore, the addition amount of the binder should be adjusted appropriately. For the amount of the binder added in step S2 above, preferably, for example, it can be 30% of the total mass of other materials except the binder in step S2.

[0054] At the same time, the dry granules in step S3 above preferably have a moisture content of ≤5.0% for example.

[0055] Step S4: Mix the dry granules and magnesium stearate to obtain a mixed material, and press the mixed material into tablets to obtain the composition.

[0056] The tablet weight of the composition obtained by tableting in step S4 above preferably is 0.6 g / tablet for example, and the weight difference limit requirement is ±5%.

[0057] According to the above introduction, the preparation method of the composition in this embodiment adopts wet granulation, with a simple process and convenient operation, which is conducive to industrial production.

[0058] In addition, this embodiment also relates to the use of the above composition. Specifically, the composition of this embodiment is used to prepare functional foods, health products or drugs.

[0059] Among them, the above-mentioned functional foods can be used for myocardial cell protection and prevention of cardiovascular diseases, for example.

[0060] The above-mentioned health products can be used for myocardial cell protection and prevention of cardiovascular diseases, for example.

[0061] The above-mentioned drugs can be used for myocardial cell protection and prevention of cardiovascular diseases, for example.

[0062] Therefore, the composition prepared in this embodiment can provide a product suitable for myocardial protection.

[0063] Based on the above introduction, for the composition, its preparation method and use of the present invention, further, in specific implementation, the following preparation examples can be referred to.

[0064] Example 1

[0065] This Example 1 is for preparing the above composition. According to the component composition of the above composition, the composition prepared in this example can be called Hong Ganlu for example, and its specific preparation steps are as follows:

[0066] S1. Crush sorbitol and sieve it through a 60-mesh sieve for standby; crush Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides and sieve them through an 80-mesh sieve for standby.

[0067] S2. Weigh 16 g of crushed and sieved sorbitol, 14 g of Ganoderma lucidum, 12 g of Astragalus membranaceus, 6 g of Eucommia ulmoides leaves, 7 g of Gardenia jasminoides, 1 g of Gastrodia elata, 12 g of sea buckthorn powder, 13 g of wolfberry powder, 12 g of red yeast rice, 6 g of D-mannitol and 29 g of 90% ethanol, mix them evenly to form a wet soft material.

[0068] S3. Pass the wet soft material through a 20-mesh sieve to obtain wet granules, put the obtained wet granules into a hot air circulation oven for drying to obtain dry granules, and control the moisture of the dry granules to be ≤5.0%.

[0069] S4. Weigh 1 g of magnesium stearate, mix the dry granules and magnesium stearate to obtain a total mixed material, and press the total mixed material with a tableting machine. The tablet weight is 0.6 g / tablet. During the tableting process, check the difference in filling amount regularly, and the weight difference limit requirement is ±5%. The Hong Ganlu is obtained.

[0070] Example 2

[0071] In Example 2, to prepare the above composition, according to the component composition of the above composition, the composition prepared in this example can be called Hongganlu for example, and its specific preparation steps are as follows:

[0072] S1. Crush sorbitol and sieve it through a 60-mesh sieve for standby; crush Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides and sieve them through an 80-mesh sieve for standby.

[0073] S2. Weigh 16 g of crushed and sieved sorbitol, 15 g of Ganoderma lucidum, 14 g of Astragalus membranaceus, 6 g of Eucommia ulmoides leaves, 6 g of Gardenia jasminoides, 2 g of Gastrodia elata, 15 g of seabuckthorn powder, 10 g of wolfberry powder, 10 g of red yeast rice, 5 g of D-mannitol, and 30 g of 90% ethanol, mix them evenly to form a wet soft material.

[0074] S3. Pass the wet soft material through a 20-mesh sieve to obtain wet granules, put the obtained wet granules into a hot air circulation oven for drying to obtain dry granules, and control the moisture content of the dry granules to be ≤5.0%.

[0075] S4. Weigh 1 g of magnesium stearate, mix the dry granules and magnesium stearate to obtain a total mixed material, press the total mixed material with a tablet press, the tablet weight is 0.6 g / tablet, during the tablet pressing process, regularly check the filling difference, and the weight difference limit requirement is ±5%, to obtain the above-mentioned Hongganlu.

[0076] Example 3

[0077] In Example 3, to prepare the above composition, according to the component composition of the above composition, the composition prepared in this example can be called Hongganlu for example, and its specific preparation steps are as follows:

[0078] S1. Crush sorbitol and sieve it through a 60-mesh sieve for standby; crush Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides and sieve them through an 80-mesh sieve for standby.

[0079] S2. Weigh 18 g of crushed and sieved sorbitol, 15 g of Ganoderma lucidum, 13 g of Astragalus membranaceus, 6 g of Eucommia ulmoides leaves, 6 g of Gardenia jasminoides, 2 g of Gastrodia elata, 15 g of seabuckthorn powder, 9 g of wolfberry powder, 9 g of red yeast rice, 6 g of D-mannitol, and 28 g of 90% ethanol, and make a wet soft material.

[0080] S3. Pass the wet soft material through a 20-mesh sieve to obtain wet granules, put the obtained wet granules into a hot air circulation oven for drying to obtain dry granules, and control the moisture content of the dry granules to be ≤5.0%.

[0081] S4. Weigh 1 g of magnesium stearate, mix the dry granules and magnesium stearate to obtain a total mixed material, press the total mixed material with a tablet press, the tablet weight is 0.6 g / tablet, during the tablet pressing process, regularly check the filling difference, and the weight difference limit requirement is ±5%, to obtain the above-mentioned Hongganlu.

[0082] Example 4

[0083] Example 4 is to prepare the above composition. According to the component composition of the above composition, the composition prepared in this example can be called Hong Ganlu for example. The specific preparation steps are as follows:

[0084] S1. Crush sorbitol and sieve it through a 60-mesh sieve for standby; crush ganoderma lucidum, astragalus membranaceus, eucommia ulmoides leaves, gastrodia elata, and gardenia jasminoides and sieve them through an 80-mesh sieve for standby.

[0085] S2. Weigh 16 g of crushed and sieved sorbitol, 16 g of ganoderma lucidum, 12 g of astragalus membranaceus, 7 g of eucommia ulmoides leaves, 8 g of gardenia jasminoides, 2 g of gastrodia elata, 16 g of seabuckthorn powder, 8 g of wolfberry powder, 8 g of red yeast rice, 6 g of D-mannitol, and 30 g of 90% ethanol, mix them evenly to form a wet soft material.

[0086] S3. Pass the wet soft material through a 20-mesh sieve to obtain wet granules. Put the obtained wet granules into a hot air circulation oven for drying to obtain dry granules, and control the moisture content of the dry granules at ≤5.0%.

[0087] S4. Weigh 1 g of magnesium stearate, mix the dry granules and magnesium stearate to obtain a total mixing material, and press the total mixing material with a tablet press. The tablet weight is 0.6 g / tablet. During the tablet pressing process, regularly check the filling difference, and the weight difference limit requirement is ±5%, to obtain the above-mentioned Hong Ganlu.

[0088] Example 5

[0089] Example 5 is to prepare the above composition. According to the component composition of the above composition, the composition prepared in this example can be called Hong Ganlu for example. The specific preparation steps are as follows:

[0090] S1. Crush sorbitol and sieve it through a 60-mesh sieve for standby; crush ganoderma lucidum, astragalus membranaceus, eucommia ulmoides leaves, gastrodia elata, and gardenia jasminoides and sieve them through an 80-mesh sieve for standby.

[0091] S2. Weigh 15 g of crushed and sieved sorbitol, 15 g of ganoderma lucidum, 14 g of astragalus membranaceus, 5 g of eucommia ulmoides leaves, 5 g of gardenia jasminoides, 2 g of gastrodia elata, 15 g of seabuckthorn powder, 10 g of wolfberry powder, 10 g of red yeast rice, 8 g of D-mannitol, and 28 g of 90% ethanol, mix them evenly to form a wet soft material.

[0092] S3. Pass the wet soft material through a 20-mesh sieve to obtain wet granules. Put the obtained wet granules into a hot air circulation oven for drying to obtain dry granules, and control the moisture content of the dry granules at ≤5.0%.

[0093] S4. Weigh 1 g of magnesium stearate, mix the dry granules and magnesium stearate to obtain a total mixing material, and press the total mixing material with a tablet press. The tablet weight is 0.6 g / tablet. During the tablet pressing process, regularly check the filling difference, and the weight difference limit requirement is ±5%, to obtain the above-mentioned Hong Ganlu.

[0094] Example 6

[0095] In this Example 6, for the preparation of the above composition, according to the component composition of the above composition, the composition prepared in this example can be called Hongganlu for example, and the specific preparation steps are as follows:

[0096] S1. Crush sorbitol and sieve it through a 60-mesh sieve for standby; crush Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata, and Gardenia jasminoides and sieve them through an 80-mesh sieve for standby.

[0097] S2. Weigh 15 g of crushed and sieved sorbitol, 14 g of Ganoderma lucidum, 12 g of Astragalus membranaceus, 6 g of Eucommia ulmoides leaves, 8 g of Gardenia jasminoides, 2 g of Gastrodia elata, 14 g of seabuckthorn powder, 10 g of wolfberry powder, 12 g of red yeast rice, 6 g of D-mannitol, and 30 g of 90% ethanol, mix them evenly to form a wet soft material.

[0098] S3. Pass the wet soft material through a 20-mesh sieve to obtain wet granules, put the obtained wet granules into a hot air circulation oven for drying to obtain dry granules, and control the moisture content of the dry granules to be ≤5.0%.

[0099] S4. Weigh 1 g of magnesium stearate, mix the dry granules and magnesium stearate to obtain a total mixed material, press the total mixed material with a tableting machine, the tablet weight is 0.6 g / tablet, and during the tableting process, regularly check the difference in filling amount, and the weight difference limit requirement is ±5%, thus obtaining the above-mentioned Hongganlu.

[0100] Verification Example

[0101] This verification example is to verify the protective effect of Hongganlu on cardiomyocytes by testing the effect of the Hongganlu prepared in Examples 1 to 6 above on the survival rate of cardiomyocytes after H2O2 injury.

[0102] For the above evaluation method of cardiomyocyte protection ability, the specific operation steps are as follows:

[0103] Cardiomyocyte culture conditions: Select the rat embryonic cardiomyocyte cell line H9c2 for culture, use DMEM high-glucose medium and add 10% fetal bovine serum (FBS) to provide sufficient nutrients and growth factors for the cells to enable them to grow well. Place the cardiomyocytes in an incubator at 37°C and 5% to maintain the appropriate pH value of the culture medium, simulate the in vivo physiological environment, and ensure that the cardiomyocytes grow in a adherent state.

[0104] Cardiomyocyte seeding: Select H9c2 cells in the logarithmic growth phase and seed them into a 96-well plate, adding 200 μL of culture medium to each well. The above selection of cardiomyocytes in the logarithmic growth phase for seeding is because the cardiomyocytes at this time have high vitality, stable physiological characteristics, and are in an active proliferation state, and can give a more accurate and stable response to subsequent experimental treatments, which is more conducive to evaluating the cardiomyocyte protection effect of the composition Hongganlu.

[0105] Verification group setting and treatment:

[0106] Normal group: The cells in this group are not interfered by additional harmful factors during the whole verification process. During the culture process, they neither contact H2O2 that can cause myocardial cell damage nor add the red manna of the composition prepared in the examples. It can reflect the state of myocardial cells under normal growth conditions and serve as the basic reference for subsequent comparison.

[0107] Damage model (H2O2) group: Add H2O2 with a final concentration of 200 μM to these myocardial cells and act for 1 - 3 hours (the specific acting time can be adjusted according to the number of inoculated cells) to obtain damaged myocardial cells. The H2O2 used in the above treatment process is a common oxidative stress inducer, which can cause redox imbalance in myocardial cells. Therefore, it is used to simulate the pathological condition of in vivo myocardial cells suffering from oxidative damage, so as to construct a myocardial cell damage model and observe the vitality changes of myocardial cells in the damaged state.

[0108] Drug administration group (H2O2 + composition): A total of six drug administration groups corresponding to the above six examples are set up. First, add 60 μL of 1 mol / L red manna prepared in the corresponding example to each well of the cells in each group, and then add H2O2 to the myocardial cells in each of the above groups and continue to incubate in the incubator for 24 hours. The purpose of the drug administration group is to allow red manna to interact with the cells in advance and observe whether it can play a preventive or alleviating protective role against the myocardial cell damage caused by the subsequently added H2O2, so as to evaluate the protective ability of the composition red manna on myocardial cells.

[0109] MTT addition and incubation: After the above different treatments are completed, add MTT solution with a concentration of 5 mg / mL to each well of the 96 - well plate, and the addition amount per well is 20 μL. Then, put the 96 - well plate back into the incubator and continue to incubate for 4 hours. During the above - mentioned myocardial cell culture process, mitochondrial succinate dehydrogenase in living cells will play a role. MTT can be reduced by mitochondrial succinate dehydrogenase in living cells to water - insoluble Formazan crystals, and the amount of its generation is positively correlated with the number and vitality of living cells. The cell vitality can be indirectly reflected by the subsequent detection of these crystals.

[0110] Dissolution and detection: After incubation, discard the supernatant, add 150 μL of dimethyl sulfoxide (DMSO) to each well, shake for 15 minutes to fully dissolve the Formazan crystals in DMSO. Then, use an enzyme - linked immunosorbent assay (ELISA) reader to measure the absorbance value (OD) at a wavelength of 570 nm. The size of this OD value is directly related to the amount of Formazan crystals generated in the cells and can indirectly reflect the number of living cells and cell vitality.

[0111] Data collection and processing: The average value of 3 parallel holes was taken at each detection point, and the experiment was repeated 3 times to reduce experimental errors and make the obtained data more accurate and reliable. Finally, the cell survival rate was calculated according to the formula "Cell survival rate % = (OD of the drug-administered group - OD of the normal group) / (OD of the model group - OD of the normal group) × 100%". By comparing the myocardial cell survival rates of different groups and evaluating the protective effect of the composition on myocardial cells through the data shown in Table 1 below.

[0112] Table 1 Cell survival rates of each group

[0113]

[0114]

[0115] From the cell survival rate data of each group presented in Table 1, it can be seen that:

[0116] The cell survival rate of the normal group was 89.18 ± 4.46%. This data indicates that when myocardial cells are not affected by damaging factors, they maintain a relatively high vitality level under normal culture conditions. This data can provide a benchmark reference for subsequent judgment of cell damage in other groups and the protective effect of drugs.

[0117] The cell survival rate of the injury model group (H2O2) was 44.56 ± 6.28%. Compared with the normal group, the myocardial cell survival rate in this group was significantly reduced, indicating that the addition of H2O2 can cause significant damage to myocardial cells, and a myocardial cell injury model can be successfully constructed, which can simulate the decrease in vitality of myocardial cells under pathological conditions such as oxidative stress.

[0118] The cell survival rates of the drug-administered groups were all between 69% and 70%. Compared with the cell survival rate of 44.56 ± 6.28% in the injury model group (H2O2), the myocardial cell survival rates of the drug-administered groups increased. It can be seen from the data in Table 1 that the cell survival rates of drug-administered groups 1 to 6 were all above 69%, indicating that adding the composition Hongganlu prepared in this example can increase the survival rate of myocardial cells after oxidative stress injury.

[0119] In summary, the composition prepared in this example has a myocardial protective effect, can relieve inflammatory symptoms and protect the cardiovascular system, can be used to prevent or treat cardiovascular diseases, improve heart function, and provides a new development for myocardial protection products. In addition, Figure 1 It can be seen that the preparation method of the composition in this embodiment has a simple process and is easy to operate, which is conducive to industrial production.

[0120] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A composition, characterized in that: The components of the composition include sorbitol, Ganoderma lucidum, seabuckthorn powder, Astragalus membranaceus, wolfberry powder, red yeast rice, D-mannitol, Eucommia ulmoides leaves, Gardenia jasminoides Ellis, Gastrodia elata Blume, and magnesium stearate.

2. The composition according to claim 1, characterized in that: The components of the composition by weight include 10 parts to 20 parts of sorbitol, 10 parts to 18 parts of Ganoderma lucidum, 10 parts to 15 parts of seabuckthorn powder, 10 parts to 15 parts of Astragalus membranaceus, 7 parts to 15 parts of wolfberry powder, 7 parts to 15 parts of red yeast rice, 2 parts to 8 parts of D-mannitol, 2 parts to 8 parts of Eucommia ulmoides leaves, 3 parts to 9 parts of Gardenia jasminoides Ellis, 1 part to 5 parts of Gastrodia elata Blume, and 0.1 part to 2 parts of magnesium stearate.

3. The method for preparing the composition according to claim 1 or 2, characterized in that, The preparation method includes: Separately pulverizing and sieving the sorbitol, Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata Blume, and Gardenia jasminoides Ellis; Mixing the sieved sorbitol, Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata Blume, Gardenia jasminoides Ellis with the seabuckthorn powder, wolfberry powder, red yeast rice, D-mannitol, and binder to form a wet soft material; Making the wet soft material into wet granules and drying the wet granules to make dry granules; Mixing the dry granules and magnesium stearate to obtain a mixed material, and tableting the mixed material to obtain the composition.

4. The preparation method of the composition according to claim 3, characterized in that: The sorbitol is sieved through a 60-mesh sieve; and / or, The Ganoderma lucidum, Astragalus membranaceus, Eucommia ulmoides leaves, Gastrodia elata Blume, and Gardenia jasminoides Ellis are all sieved through an 80-mesh sieve.

5. The preparation method of the composition according to claim 3, wherein: The binder includes ethanol with a volume fraction of 90%.

6. The method for preparing the composition according to claim 3, characterized in that: The wet soft material is sieved through a 20-mesh sieve to make the wet granules.

7. The preparation method of the composition according to claim 3, characterized in that: The moisture content of the dry granules ≤ 5.0%.

8. The use of the composition according to claim 1 or 2, characterized in that: The composition is used for preparing functional foods, health products, or pharmaceuticals.

9. The use of the composition according to claim 8, characterized in that: The functional food is used for protecting cardiomyocytes and preventing cardiovascular diseases; and / or, the health product is used for protecting cardiomyocytes and preventing cardiovascular diseases; and / or, The pharmaceutical is used for protecting cardiomyocytes and preventing cardiovascular diseases.

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