Nutritional supplement for coronary heart disease as well as preparation method and application of nutritional supplement

Abstract

The invention discloses a coronary heart disease nutritional supplement as well as a preparation method and application thereof. The supplement is prepared from nattokinase, red yeast rice powder, resistant dextrin, intactin, whey protein, theaflavin and mogroside. Through the synergistic effect of the nattokinase and the red yeast rice powder, the supplement has the effects of thrombolysis and blood fat reduction, and can effectively improve the heart function; basic components such as resistant dextrin and intactin provide nutritional support, and theaflavin and mogroside have an anti-oxidation effect. The preparation method comprises the steps of raw material preparation, drying treatment, mixing, active ingredient adding, subpackaging and packaging, the temperature and humidity are strictly controlled, and the product quality is ensured. And through vacuum packaging and automatic weighing treatment, it is guaranteed that the ingredients of each supplement are uniform and consistent. The supplement is suitable for coronary heart disease patients, is suggested to be taken 2-3 times a day, 20g each time, and is continuously taken for 3 months, so that the cardiac function is remarkably improved, and cholesterol is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of nutritional supplements, in particular to a nutritional supplement for coronary heart disease and a preparation method and application thereof. Background Art

[0002] Coronary heart disease is a common cardiovascular disease. Its main feature is coronary artery atherosclerosis, which leads to insufficient blood supply to the myocardium. In severe cases, it may cause serious consequences such as angina pectoris, heart failure, and arrhythmia. Clinical treatment of coronary heart disease mainly focuses on drug therapy, surgical intervention, and cardiac rehabilitation training. However, many patients with coronary heart disease suffer from malnutrition, decreased physical strength, and other problems during treatment. These factors not only affect the patient's rehabilitation effect, but may also aggravate the progression of the disease.

[0003] Currently, there are limited types of nutritional supplements for patients with coronary heart disease on the market, and most products fail to effectively combine the special nutritional needs of patients, and cannot take into account both the prevention and treatment of coronary heart disease and the recovery of patients' physical strength. The existing technology lacks a nutritional supplement that can help patients with coronary heart disease improve their nutritional status and promote cardiac rehabilitation without increasing fat accumulation and other negative effects. Therefore, the development of a nutritional supplement specifically for patients with coronary heart disease has broad clinical application prospects. Summary of the invention

[0004] The purpose of the present invention is to provide a nutritional supplement for coronary heart disease and a preparation method and application thereof, which has the advantages of improving the nutritional status of patients with coronary heart disease, promoting cardiac rehabilitation, reducing fat accumulation, and improving physical strength, and solves the problem that existing nutritional supplements cannot take into account both the prevention and treatment of coronary heart disease and physical recovery.

[0005] To achieve the above-mentioned purpose, the present invention provides the following technical scheme: a nutritional supplement for coronary heart disease, the supplement consisting of the following components: a functional active ingredient group: nattokinase, red yeast rice powder; a basic nutritional support ingredient group: resistant dextrin, whole protein, whey protein, soluble dietary fiber, water-soluble vitamins; an auxiliary health maintenance ingredient group: theaflavins, mogroside.

[0006] Preferably, the nutritional supplement for coronary heart disease includes the following specific content ranges of the components:

[0007] Nattokinase: 150-250FU / g; Red yeast rice powder: 1.5-2.5mg / g; Resistant dextrin: 0.35-0.6g / g; Theaflavin: 3.5-4.5mg / g; Mogroside: 3.5-4.5mg / g; Whole protein: 0.55-0.65g / g; Whey protein: 0.07-0.08g / g; Soluble dietary fiber: 0.035-0.04g / g; Water-soluble vitamins: 0.035-0.04g / g.

[0008] Preferably, the specific optimized formula of the nutritional supplement for coronary heart disease is: nattokinase: 200-220FU / g; red yeast rice powder: 2mg / g; resistant dextrin: 500mg / g; theaflavin: 4mg / g; mogroside: 4mg / g; whole protein: 600mg / g; whey protein: 75mg / g; soluble dietary fiber: 37.5mg / g; water-soluble vitamins: 37.5mg / g.

[0009] Preferably, the content of nattokinase is 4000±100FU per package, and its activity is maintained at more than 90% of the initial value in an environment of 20-40°C; the particle size of the red yeast rice powder is 10-30 microns, and the content of Monacolin K is 1.0%-1.2%; the moisture content of the resistant dextrin is controlled at ≤4%, and the solubility is 90%-95%; the purity of theaflavins is 90%-95%, and the particle diameter range is 5-15 microns; the sweetness of the mogroside is 180-200 times that of sucrose, and the solubility in water is 98%-100%.

[0010] A method for preparing a nutritional supplement for coronary heart disease comprises the following steps:

[0011] S1. Raw material preparation:

[0012] S1.1. Weigh natto powder, red yeast rice powder, resistant dextrin, theaflavins, mogroside, whole protein, whey protein, soluble dietary fiber, and water-soluble vitamins, and conduct quality inspection on each raw material to ensure compliance with the standards;

[0013] S1.2. Check the activity of natto powder to ensure that its nattokinase content reaches 4000FU;

[0014] S1.3. Check the particle size of red yeast rice to ensure that the particle size is 10-30 microns;

[0015] S1.4. Place the natto powder in a sterile environment at a temperature of 30-40°C and a humidity of 5-10%, and sterilize it using ultraviolet sterilization or a low pressure of 70-100 Pascal for 15-30 minutes;

[0016] S2. Drying treatment:

[0017] Place the red yeast rice powder and theaflavins in a drying oven at 45°C ± 2°C for 2.5 hours, control the humidity at ≤10%, and ensure that the moisture content is controlled at ≤4%;

[0018] S2.1. Spread the red yeast rice powder evenly on the baking tray to ensure even drying;

[0019] S2.2. Perform constant temperature drying under low humidity conditions (humidity ≤ 10%);

[0020] S3, preliminary mixing:

[0021] Put resistant dextrin, dried red yeast rice powder, theaflavins, whole protein, whey protein, soluble dietary fiber, and water-soluble vitamins into a mixer according to the proportions, and stir at room temperature for 10-15 minutes to form a preliminary mixture;

[0022] S3.1. Add the resistant dextrin into the mixer first according to the proportion order, and then gradually add red yeast rice powder and theaflavins;

[0023] S3.2, stirring at 300-500 rpm for 15 minutes to ensure uniform mixing;

[0024] S4. Addition of active ingredients:

[0025] Add the processed natto powder and mogroside to the preliminary mixture and continue stirring for 10-20 minutes to ensure that the components are evenly distributed to form a uniform nutritional supplement powder;

[0026] S5. Packaging:

[0027] The evenly mixed powder is packaged into 20g pieces by automatic packaging equipment to ensure that each piece of product contains the same ingredients and dosage;

[0028] S5.1. Use precision packaging machines to ensure that the weight of each package is controlled within the range of 20g ± 0.05g;

[0029] S5.2. Automatically weigh and inspect, and remove packaging strips with an error greater than 0.1 gram;

[0030] S6. Packaging and storage:

[0031] S6.1. Seal the subpackaged products in moisture-proof and light-proof aluminum foil bags to ensure product stability and shelf life;

[0032] S6.2. Store the packaged products in an environment with a temperature below 25°C and a humidity not exceeding 50%.

[0033] Preferably, the S1 raw material preparation step further includes the following detailed steps:

[0034] S1a, store natto powder at 20-30°C to avoid loss of activity and keep its moisture content below 5%;

[0035] S1b, screening the red yeast rice powder, resistant dextrin and theaflavins to ensure that their particle sizes are 10-30 μm, 200-500 μm and 5-15 μm respectively;

[0036] S1c. Test the water solubility of mogroside to ensure that its solubility is above 98%.

[0037] Preferably, the S3 preliminary mixing step further comprises the following refinement steps:

[0038] S3a, first add the resistant dextrin into the mixer according to the proportion, and pre-mix at a low speed for 3 minutes;

[0039] S3b, gradually add red yeast rice powder and theaflavins, increase the stirring speed to 350-450 rpm, and continue stirring for 10 minutes to ensure that all components are initially mixed evenly;

[0040] S3c. During the initial mixing process, monitor the uniformity of the mixture to ensure that there is no particle settling or powder separation.

[0041] Preferably, the S5 packaging step further includes the following detailed steps:

[0042] S5a, use automatic weighing equipment to ensure that the net weight of each package is 20g ± 0.05g, and products with errors exceeding the range will be automatically rejected;

[0043] S5b. During the subpackaging process, use vacuum packaging equipment to seal to ensure that there is no air or moisture in the packaging process to avoid the loss of ingredient effectiveness;

[0044] S5c. Pass the packaged products through X-ray inspection equipment one by one to ensure the integrity of the packaging, and remove products with damaged packaging or loose seals.

[0045] An application of a nutritional supplement for coronary heart disease comprises the following steps:

[0046] a) taking the prepared nutritional supplement for coronary heart disease in divided doses of 20 grams per strip 2-3 times a day;

[0047] b) Take it 30 minutes before meals with warm water, and avoid taking it with high-fat or high-sugar foods;

[0048] c) One course of treatment is 3 months of continuous use, and the patient's health indicators should be monitored regularly.

[0049] Compared with the prior art, the present invention has the following beneficial effects:

[0050] 1. The present invention achieves the effects of dissolving blood clots, lowering blood lipids, improving myocardial blood supply and heart function by providing a functional active ingredient group, including nattokinase and red yeast rice powder, and can effectively prevent and assist in the treatment of coronary heart disease.

[0051] 2. The present invention improves the overall nutritional status of patients, promotes intestinal health, and controls blood sugar and blood lipid levels by providing a basic nutritional support component group, including resistant dextrin. It is particularly suitable for patients with coronary heart disease accompanied by malnutrition.

[0052] 3. The present invention provides a group of auxiliary health maintenance ingredients, including theaflavins and mogrosides, which provide strong antioxidant effects and sweetness regulation, which can not only reduce the inflammatory response in patients with coronary heart disease, but also improve the quality of life of patients without increasing calorie intake.

[0053] 4. The preparation method adopted by the present invention is scientific and controllable, which ensures the stability and effectiveness of each component, especially through low-temperature sterilization, drying and precise packaging process, which ensures the quality and safety of the nutritional supplement and extends the shelf life of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Figure 1 This is a schematic diagram of the components of the nutritional supplement for coronary heart disease of the present invention;

[0055] Figure 2 This is a schematic diagram of the specific component contents of the nutritional supplement for coronary heart disease of the present invention;

[0056] Figure 3 It is a schematic diagram of the physical and chemical properties of the ingredients of the nutritional supplement for coronary heart disease of the present invention;

[0057] Figure 4 This is a schematic diagram of the preparation method of the nutritional supplement for coronary heart disease of the present invention;

[0058] Figure 5 This is a schematic diagram of the steps for preparing and refining raw materials of the present invention;

[0059] Figure 6 This is a schematic diagram of the preliminary mixing and refining steps of the present invention;

[0060] Figure 7 It is a detailed schematic diagram of the packaging steps of the present invention;

[0061] Figure 8 This is a schematic diagram of the application method of the nutritional supplement for coronary heart disease of the present invention. DETAILED DESCRIPTION

[0062] The following will be combined with the drawings 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 creative work are within the scope of protection of the present invention.

[0063] See also Figures 1 to 8 The present invention proposes a nutritional supplement for coronary heart disease, which consists of three major parts: functional active ingredients, basic nutritional support ingredients, and auxiliary health maintenance ingredients. This formula design is targeted at the special needs of patients with coronary heart disease, fully considering the pathological characteristics of the disease and the necessity of physical recovery of patients, and aims to achieve auxiliary treatment of coronary heart disease and improvement of the overall health of patients through a scientific nutritional formula.

[0064] 1. Functional active ingredient group: Nattokinase, red yeast rice. Nattokinase is an enzyme extracted from natto with significant thrombolytic function. It effectively dissolves blood clots and improves blood circulation by promoting the decomposition of fibrin, which is very important for the prevention and treatment of atherosclerosis and thrombosis in coronary heart disease. Red yeast rice is obtained by fermenting red yeast rice and contains Monacolin K, which can effectively lower blood lipid levels, especially cholesterol. These functional active ingredients work together to help patients with coronary heart disease reduce the risk of atherosclerosis and reduce the possibility of myocardial ischemia.

[0065] 2. Basic nutritional support ingredient group: resistant dextrin, whole protein, whey protein, soluble dietary fiber, water-soluble vitamins. Resistant dextrin is a soluble dietary fiber that has the function of regulating intestinal flora and improving the digestive system. It can not only help patients maintain a healthy intestinal environment, but also control postprandial blood sugar and blood lipid levels, and effectively reduce the incidence of cardiovascular diseases. In addition, resistant dextrin is not digested and absorbed like ordinary carbohydrates, so it can provide necessary energy support for patients with coronary heart disease while avoiding unnecessary fat accumulation.

[0066] Whole protein is a nutrient composed of whole proteins that can provide the body with a complete amino acid profile, help maintain muscle mass and enhance immune function. Whole protein is particularly suitable for patients with coronary heart disease because it can provide patients with balanced nutritional support, help physical recovery and maintain overall health.

[0067] Whey protein is a high-quality protein that is easy to digest and absorb. It is rich in branched-chain amino acids and can promote muscle repair and enhance immune function. Whey protein is particularly important in patients with coronary heart disease because it can help patients maintain and increase muscle mass during the recovery process, especially in patients who are hospitalized for a long time or have a lot of physical exertion.

[0068] In addition to resistant dextrin, other soluble dietary fibers also play an important role in the present invention. They can regulate blood sugar levels, promote intestinal health, and help lower cholesterol levels, thereby reducing the risk of cardiovascular disease. The unique function of soluble dietary fiber is that it can absorb cholesterol and excrete it from the body, further helping patients with coronary heart disease manage blood lipid levels.

[0069] Water-soluble vitamins provide the body with essential nutrients, help promote energy metabolism, enhance immune function, and have antioxidant effects. B vitamins play a key role in energy metabolism and support the normal functioning of the heart, while vitamin C helps protect cardiovascular health and reduces inflammation and oxidative stress through antioxidant effects.

[0070] 3. Auxiliary health maintenance ingredient group: theaflavins, mogrosides. Theaflavins are a polyphenol extracted from tea leaves. They have strong antioxidant function, can remove free radicals in the body and reduce inflammatory response. This is especially important in patients with coronary heart disease, because one of the main causes of atherosclerosis is oxidative stress in the body. Mogrosides are a natural sweetener that provides sweetness without increasing blood sugar, which is suitable for the dietary control requirements of patients with coronary heart disease. In addition, mogrosides themselves also have certain antioxidant effects.

[0071] The coronary heart disease nutritional supplement of the present invention can prevent and improve the symptoms of coronary heart disease and meet the daily nutritional needs of patients through the combined action of scientifically proportioned functional ingredients, basic nutritional ingredients and auxiliary health ingredients. The synergistic effect of nattokinase and red yeast rice powder helps improve blood circulation and prevent thrombosis, resistant dextrin provides patients with a stable energy source and avoids blood sugar fluctuations, while theaflavins and mogrosides play an antioxidant and anti-inflammatory role, further improving the overall health of patients. During the implementation process, the patient takes the supplement every day according to the doctor's advice, and gradually improves the blood lipid level, blood circulation and heart function in the body. Long-term use can also prevent the recurrence of coronary heart disease and promote rehabilitation effects. The coronary heart disease nutritional supplement of the present invention is adapted to the individual needs of different patients by accurately designing the content of each ingredient. Each ingredient in the formula can be adjusted within a wider dosage range, or controlled within a more precise dosage range according to the specific patient's condition to ensure the safety and effectiveness of nutritional supplementation.

[0072] 1. Nattokinase. The function of nattokinase is to dissolve blood clots and improve blood circulation. In the supplement of the present invention, the content of nattokinase ranges from 150-250FU / g. This range provides flexible adjustment space for patients with different conditions. When used specifically, the nattokinase content of standard patients can be controlled at 200-220FU / g. This dose has been clinically verified to ensure the thrombolytic effect while avoiding adverse reactions.

[0073] 2. Red yeast rice: Red yeast rice is rich in Monacolin K, which can effectively lower cholesterol and reduce the risk of atherosclerosis. The content of red yeast rice in supplements ranges from 1.5-2.5 mg / g to suit the blood lipid levels of different patients. In conventional supplementation regimens, the content of red yeast rice can be optimized to 2 mg / g, a dose that can effectively help patients control cholesterol levels without causing common side effects.

[0074] 3. Resistant dextrin: As a soluble dietary fiber, resistant dextrin can regulate intestinal flora and help control blood sugar and blood lipids. The content of resistant dextrin in supplements ranges from 350-600 mg / g. For most patients with coronary heart disease, the standard dose of resistant dextrin can be controlled at 500 mg / g. This dose helps maintain intestinal health without causing discomfort such as indigestion.

[0075] 4. Theaflavins: Theaflavins are a powerful antioxidant that can remove free radicals in the body and reduce oxidative stress. In the supplement of the present invention, the content of theaflavins ranges from 3.5 to 4.5 mg / g to accommodate different degrees of oxidative stress and inflammatory response. In conventional use, the content of theaflavins can be precisely controlled at 4 mg / g, which can provide a strong antioxidant effect in long-term use and effectively delay the progression of arteriosclerosis.

[0076] 5. Mogrosides. Mogrosides not only provide sweetness, but also have blood sugar regulation and anti-oxidation effects. The content of mogrosides in supplements ranges from 3.5-4.5 mg / g, which can meet the taste needs of patients. In routine use, the standard content of mogrosides is 4 mg / g, which can provide sweetness without affecting blood sugar levels.

[0077] 6. Whole protein. Whole protein provides comprehensive amino acid supplementation required by patients with coronary heart disease, which helps to enhance immune function and maintain muscle mass. In the supplement of the present invention, the content of whole protein ranges from 500-650 mg / g, which provides flexible adjustment space for patients with different physiques and nutritional needs. For standard patients, the recommended dose of whole protein can be optimized to 600 mg / g. This dose has been experimentally verified to ensure the effect of physical recovery and nutritional support for patients without incurring additional burden.

[0078] 7. Whey protein: As an efficient protein source, whey protein is easily absorbed by the human body and helps promote muscle repair and maintain physical strength. The whey protein content in the supplement ranges from 50-100 mg / g, which provides sufficient support for the patient's physical recovery and muscle protection. The whey protein content of standard patients can be optimized to 75 mg / g, a dose that has been shown to support muscle repair without negative effects on metabolism.

[0079] 8. Soluble dietary fiber, the content of soluble dietary fiber in supplements ranges from 30-50 mg / g, which can help regulate intestinal flora, improve digestive system function and reduce blood lipid and blood sugar levels. In routine use, the standard dose of soluble dietary fiber can be optimized to 37.5 mg / g, which can ensure the maintenance of intestinal health and provide support for long-term cardiovascular health.

[0080] 9. Water-soluble vitamins. Water-soluble vitamins (such as vitamin B complex and vitamin C) are essential for patients with coronary heart disease. They can enhance immune function, support energy metabolism and have antioxidant effects. The content of water-soluble vitamins in supplements ranges from 30-50 mg / g and can be adjusted according to the needs of the patient. For standard patients, the recommended water-soluble vitamin content is 37.5 mg / g, which ensures that the patient's daily vitamin needs are effectively met while supporting heart health.

[0081] The nutritional supplement for coronary heart disease of the present invention ensures that each ingredient can exert the best effect by flexibly adjusting and accurately controlling the content of each ingredient. The wide range of content design provides sufficient flexibility for patients with different conditions and constitutions, while the small range of precise control provides an optimized treatment plan for standard patients. The synergistic effect of each ingredient enables the supplement to not only effectively improve the patient's heart function, but also provide comprehensive support for overall health. The nutritional supplement for coronary heart disease of the present invention not only ensures the effectiveness of each ingredient through scientific proportioning and dosage design, but also further optimizes the physical and chemical properties of key ingredients to ensure its stability and absorption effect in actual use.

[0082] 1. The content and stability of nattokinase. According to the present invention, the content of nattokinase in each package is 4000±100FU. This dose has been clinically verified and is considered to be an effective dose for thrombolysis and improving blood circulation. While ensuring the thrombolytic effect, the activity of nattokinase can still be maintained at more than 90% in an environment of 20-40°C, which means that the ingredient has a very high stability during storage and use at room temperature. This stability ensures that the thrombolytic effect of the supplement will not decrease due to temperature changes during transportation and storage, thereby maximizing its therapeutic effect.

[0083] 2. Particle size of red yeast rice and content of monacolin K. The particle size of red yeast rice in the present invention is designed to be 10-30 microns. This range ensures the uniform distribution of red yeast rice in the supplement and its absorption effect in the human body. When the particle size is smaller, the powder is more easily absorbed by the human body, thereby improving the bioavailability of monacolin K. The content of monacolin K in red yeast rice is controlled at 1.0%-1.2%, which is a key parameter for its lipid-lowering effect. It can effectively inhibit the synthesis of cholesterol, help patients with coronary heart disease lower low-density lipoprotein cholesterol (LDL-C), and prevent atherosclerosis.

[0084] 3. Moisture content and solubility of resistant dextrin. As the basic nutritional support ingredient of the present invention, the moisture content of resistant dextrin is strictly controlled at ≤4%. This standard ensures the stability and quality of resistant dextrin. When the moisture content is low, resistant dextrin can maintain a longer shelf life and will not absorb moisture and deteriorate during storage. In addition, the solubility of resistant dextrin is controlled at 90%-95%, ensuring that it can be quickly dissolved and effectively absorbed in the human body, helping to regulate intestinal flora, promote intestinal health, and further control the patient's blood sugar and blood lipid levels.

[0085] 4. Purity and particle diameter of theaflavins. Theaflavins are a powerful antioxidant. The purity of theaflavins in the present invention is 90%-95%. This high purity ensures the maximization of its antioxidant and anti-inflammatory effects. The higher the purity, the stronger the efficacy of theaflavins, which can more effectively remove free radicals in the body and reduce the risk of arteriosclerosis. The particle diameter of theaflavins is designed to be 5-15 microns. This particle size ensures its uniform distribution in the supplement and makes it easier for the human body to absorb, further improving its antioxidant effect.

[0086] 5. Sweetness and solubility of mogroside. As an auxiliary health maintenance ingredient of the present invention, mogroside provides a natural sweetness alternative, and its sweetness is 180-200 times that of sucrose, which means that even if a small amount of mogroside is used, it can meet the patient's taste needs without increasing blood sugar. Mogroside has very good water solubility, and its solubility is controlled at 98%-100%, which ensures that it can be quickly and completely dissolved in water, which is convenient for patients to ingest and absorb. This feature makes mogroside an ideal choice for diabetic patients and patients with coronary heart disease who need to control blood sugar.

[0087] The preparation method of the coronary heart disease nutritional supplement of the present invention comprises multiple key steps to ensure the quality, stability and uniformity of the ingredients of the product. Each step is scientifically designed to maximize the activity and absorption effect of each component and ensure the consistency and safety of the finished product.

[0088] S1. Raw material preparation. Raw material preparation is the first step of the present invention, which ensures that all raw materials meet the quality standards and can play the best role in the final product.

[0089] S1.1: Weigh natto powder, red yeast rice powder, resistant dextrin, theaflavins, mogrosides, whole protein, whey protein, soluble dietary fiber, water-soluble vitamins, and perform quality checks on each raw material. Through strict quality control, ensure that the purity, activity, and content of each ingredient meet the standards. This process is critical to ensuring the effectiveness of the supplement.

[0090] S1.2: Check the activity of nattokinase in natto powder to ensure that its content reaches 4000FU. This is the core functional ingredient in the product and its activity must be strictly controlled to ensure that the supplement exerts its thrombolytic effect.

[0091] S1.3: Check the particle size of red yeast rice powder to ensure that its particle size is 10-30 microns. Particle size control ensures the uniform distribution of red yeast rice powder in the supplement and improves its absorption efficiency in the human body.

[0092] S1.4: Place the natto powder in a sterile environment at 30-40°C and humidity controlled at 5-10% for sterilization. The sterilization is carried out under ultraviolet light or low pressure (70-100 Pascal) conditions for 15-30 minutes to ensure that the natto powder remains active during the sterilization process and avoid microbial contamination.

[0093] S2. Drying treatment: Drying treatment is to reduce the moisture content in the raw materials and ensure the stability and long-term effectiveness of the product.

[0094] S2.1: Spread the red yeast rice and theaflavins evenly on a baking tray and place in a drying oven at 45℃±2℃ for 2.5 hours with humidity controlled at ≤10%. This step ensures that the moisture content in the raw materials is controlled at ≤4% to prevent deterioration during storage.

[0095] S2.2: Perform constant temperature drying in a low humidity environment (humidity ≤ 10%) to ensure that the moisture content of red yeast rice and theaflavins is stable. After drying, the raw materials can maintain their stability and quality.

[0096] S3. Preliminary mixing. Preliminary mixing ensures the uniform distribution of basic ingredients and is one of the key links in the preparation process.

[0097] S3.1: Add resistant dextrin, red yeast rice powder, theaflavins, whole protein, whey protein, soluble dietary fiber, and water-soluble vitamins into the mixer in order. Add resistant dextrin first, and then gradually add other ingredients to ensure that each ingredient is evenly distributed to avoid uneven mixing.

[0098] S3.2: The mixing speed is controlled at 300-500 rpm and the mixing time is 10-15 minutes. This speed and time control can ensure that the components are fully mixed so that the active ingredients in the supplement are evenly distributed in each product.

[0099] S4. Adding active ingredients: After the initial mixing is completed, adding active ingredients is a key step to ensure that the supplement exerts its therapeutic effect. Sterilized natto powder and mogrosides are added to the initial mixture and stirred again for 10-20 minutes to ensure that these active ingredients are evenly distributed to form a uniform nutritional supplement powder. This process ensures that the active ingredient content in the supplement is consistent and exerts the best effect.

[0100] S5. Packaging: The precision of the packaging step determines the consistency of ingredients and dosage accuracy of each supplement.

[0101] S5.1: The mixed powder is packaged into 20g per strip by automatic packaging equipment to ensure that each strip contains the same ingredients and dosage. The accuracy of automatic packaging is controlled at 20g ± 0.05g, and real-time monitoring is carried out by weighing equipment to ensure the accuracy of each package.

[0102] S5.2: Use automatic weighing and inspection equipment to eliminate packaging strips with an error greater than 0.1 grams. Ensure that every product meets the standards and avoid affecting product quality due to inconsistent weight.

[0103] S6. Packaging and storage. The final packaging and storage steps ensure the long-term stability and effectiveness of the product.

[0104] S6.1: The subpackaged products are sealed in moisture-proof and light-proof aluminum foil bags to ensure that the products will not be affected by moisture or light and deteriorate during storage and transportation. This packaging method greatly extends the shelf life of the product.

[0105] S6.2: Store the sealed packaged products in an environment below 25°C and with a humidity not exceeding 50% to ensure the stability of the ingredients and the efficacy of the products. This storage condition ensures that the supplement maintains its efficacy during long-term storage and is not affected by changes in the external environment. The nutritional supplement for coronary heart disease of the present invention ensures the stability and uniform distribution of the ingredients in each step through a precise preparation method. Through reasonable raw material preparation, sterilization, drying, mixing and packaging processes, a nutritional supplement for coronary heart disease with high efficiency, stability and consistency is finally obtained. This method not only ensures the stability of the active ingredients in the product, but also ensures that each product has consistent dosage and quality, which is convenient for patients to use for a long time.

[0106] In the raw material preparation stage: S1a, storage of natto powder. When preparing a nutritional supplement for coronary heart disease, the storage conditions of natto powder have a crucial impact on its activity. In order to ensure the thrombolytic effect of nattokinase, the present invention stipulates that natto powder should be stored in an environment of 20-30°C, and its water content must be kept below 5%. The design of this storage condition helps to prevent natto powder from losing its activity in a high temperature or high humidity environment, thereby ensuring that the activity of nattokinase will not be weakened in the subsequent preparation process. A low humidity environment avoids the growth of microorganisms and extends the shelf life of natto powder.

[0107] S1b, Powder Screening, Particle size control of red yeast rice, resistant dextrin and theaflavins is critical to ensure uniformity and bioavailability in supplements. The particle size of red yeast rice is controlled at 10-30 microns, which can effectively improve the absorption efficiency of Monacolin K and ensure uniform distribution in the supplement.

[0108] The particle size of resistant dextrin is 200-500 microns, which ensures effective mixing of resistant dextrin while providing sufficient dietary fiber support to help regulate the patient's intestinal health. The particle size of theaflavins is controlled at 5-15 microns. This tiny particle size can increase its absorption rate in the body and exert antioxidant and anti-inflammatory effects. The purpose of screening these powders is to ensure that the particle size of each ingredient meets the standard to improve the uniformity of the ingredients and the stability of the final product.

[0109] S1c, water solubility test of mogroside. As a natural sweetener, the solubility of mogroside directly affects its role in supplements. In the present invention, the water solubility of mogroside is required to reach more than 98%. This testing step can ensure that it dissolves and is absorbed quickly after entering the human body, and will not cause particle precipitation or taste problems in the supplement. This high solubility feature ensures the patient's comfort and sweetness experience when eating, and will not have a negative impact on blood sugar.

[0110] During the initial mixing process: S3a, low speed premixing

[0111] During the mixing process, first add the resistant dextrin into the mixer according to the proportion and pre-mix at a low speed for 3 minutes. This step is to evenly distribute the resistant dextrin first, ensuring that the subsequent mixing of the ingredients will not be uneven due to the large volume of resistant dextrin. Slow-speed mixing helps reduce dust and improve mixing accuracy.

[0112] S3b, gradually add red yeast rice and theaflavins. After the resistant dextrin is premixed, gradually add red yeast rice and theaflavins, and increase the stirring speed to 350-450 rpm for 10 minutes. The gradual addition process can prevent powder accumulation or agglomeration and ensure that all ingredients are evenly distributed. The increase in stirring speed makes the mixing more complete, which can ensure that the red yeast rice and theaflavins are completely integrated with the resistant dextrin to achieve the desired uniformity.

[0113] S3c. Monitoring of mixing uniformity. In order to ensure the uniformity of the preliminary mixture, the present invention specifically proposes monitoring the uniformity of the mixture during the mixing process. This monitoring process can be achieved through visual observation or instrument detection to ensure that no particle sedimentation or powder separation occurs during the mixing process. This can avoid the uneven content of certain ingredients in the final product, ensure that the proportion of ingredients in each supplement is consistent, and achieve the desired therapeutic effect.

[0114] During the supplement packaging process, we ensure that the weight of each product is consistent and the packaging is sealed properly, and use automated equipment to detect and remove unqualified products.

[0115] S5a, automatic weighing equipment to ensure net weight. During the packaging process, the present invention uses automatic weighing equipment to ensure that the net weight of each product is 20.0±0.05 grams. The precise weighing control of this step is extremely critical to ensure that the content of each package is consistent, so that each patient can take the same dose of nutrients each time they take it. The automatic weighing equipment can detect the weight of the product in real time, and the product with an error exceeding the specified range will be automatically rejected to avoid affecting the efficacy of the product due to inconsistent weight.

[0116] S5b, vacuum packaging ensures sealing. During the subpackaging process, the present invention uses vacuum packaging equipment for sealing to ensure that there is no air or moisture in the packaging process. This process can not only extend the shelf life of the product, but also prevent the ingredients from being ineffective due to exposure to air, especially active ingredients such as nattokinase. Under vacuum packaging conditions, the stability of the ingredients is effectively guaranteed, avoiding the degradation or activity reduction of the ingredients caused by moisture or oxygen.

[0117] S5c, X-ray inspection to ensure packaging integrity. In order to ensure the packaging integrity of each product, the present invention further uses X-ray inspection equipment to inspect each packaged product. X-ray inspection can quickly identify whether the package is damaged or not tightly sealed, so as to eliminate unqualified products. This process can ensure that each supplement will not leak or become ineffective due to packaging problems during transportation and storage, thereby improving the safety and reliability of the product.

[0118] The method for using the nutritional supplement for coronary heart disease of the present invention in practical application comprises the following steps:

[0119] a) Daily dosage and number of times of administration. According to the present invention, patients with coronary heart disease should take 20 grams of each strip daily, 2-3 times a day. This dosage design is based on the clinical needs assessment of patients, ensuring that patients can stably obtain necessary nutrients and active substances (such as nattokinase and Monacolin K in red yeast rice powder) when taking supplements in divided doses every day. The divided dose design also avoids taking too many ingredients at one time, reduces the burden on the digestive system, and helps the sustained release and absorption of ingredients.

[0120] b) Time of use and dietary recommendations: It is recommended that the supplement be taken 30 minutes before meals with warm water to help dissolve and absorb the supplement. Taking before meals helps improve the absorption efficiency of the ingredients, especially when there is no other food interference in the patient's gastrointestinal tract. At the same time, during the use of the supplement, avoid taking it with high-fat and high-sugar foods to avoid affecting the efficacy of the ingredients. A high-fat diet may interfere with the absorption of nattokinase, while a high-sugar diet may offset the blood sugar regulating effect of mogroside.

[0121] c) Taking cycle and course of treatment: The nutritional supplement for coronary heart disease of the present invention recommends that patients take it for 3 consecutive months as a course of treatment. During this period, the ingredients in the supplement can continue to play its thrombolytic, lipid-lowering, anti-oxidation and other effects. Patients should regularly test their health indicators, such as blood lipids, blood sugar and heart function, to evaluate the effect of the supplement, and adjust the dosage or course length according to the test results. Through this long-term and continuous use, patients can significantly improve their cardiovascular health and reduce the risks associated with coronary heart disease.

[0122] Example 1: Study on the effect of nutritional support on patients with coronary heart disease

[0123] This embodiment conducts a clinical study on patients with coronary heart disease to explore the nutritional support and cardiac rehabilitation effects of the coronary heart disease nutritional supplement of the present invention on patients with coronary heart disease. The technical purpose is to improve the nutritional status and cardiac function of patients through the use of supplements, while reducing the incidence of complications and improving the quality of life of patients. In the study, a total of 200 patients with coronary heart disease who were hospitalized in Jiangbin Hospital of Guangxi Zhuang Autonomous Region from January 2022 to July 2024 were selected. The patients were randomly divided into two groups: 100 cases in each nutrition group and control group. Patients in the nutrition group used coronary heart disease nutritional supplements daily, while patients in the control group received an ordinary low-salt, low-fat diet.

[0124] Formula of nutritional supplement: Nattokinase: 150-250FU / g; Red yeast rice powder: 1.5-2.5mg / g; Resistant dextrin: 0.35-0.6g / g; Theaflavin: 3.5-4.5mg / g; Mogroside: 3.5-4.5mg / g; Whole protein: 0.55-0.65g / g; Whey protein: 0.07-0.08g / g; Soluble dietary fiber: 0.035-0.04g / g; Water-soluble vitamins: 0.035-0.04g / g.

[0125] Comparative experimental design: Before and after the intervention, the patients' body mass index (BMI), upper arm muscle circumference (MAC), triceps skinfold thickness (TSF) were measured, and blood indicators (hemoglobin (HB), total protein (TP), albumin (ALB)) were tested. At the same time, key physiological indicators of coronary heart disease were tested, including cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), incidence of angina pectoris, incidence of heart failure, incidence of arrhythmia, etc.

[0126] In addition, cardiopulmonary exercise testing was used to measure the patients' maximal oxygen uptake (VO2max) and anaerobic threshold (AT), and the Barthel assessment scale was used to evaluate the ability of daily living (ADL).

[0127] Experimental data comparison results:

[0128]

[0129] The results of the present embodiment show that the BMI and MAC of the nutrition group patient significantly increase, indicating that the nutritional status of the patient has been improved, and fat accumulation (TSF unchanged) is not caused. Blood indexes (HB, TP, ALB) are also significantly improved, indicating that the body nutritional status is improved. Cardiac function indexes (TC, TG, LDL-C) are greatly reduced, and the incidence of complications (angina pectoris, heart failure, arrhythmia) is significantly reduced. In addition, the cardiopulmonary function (VO2max, AT) and daily living ability (ADL) of the nutrition group patient are significantly better than those of the control group, indicating that the coronary heart disease nutritional supplement of the present invention can effectively improve the overall health of coronary heart disease patients.

[0130] Example 2: Study on the efficacy of coronary heart disease patients with chronic heart failure

[0131] This example is aimed at patients with coronary heart disease and chronic heart failure, and aims to evaluate the effect of the coronary heart disease nutritional supplement of the present invention on improving the cardiac function and nutritional status of patients with heart failure. The technical purpose is to help patients improve their cardiac function and improve malnutrition through refined nutritional support.

[0132] 200 patients with chronic heart failure from the Department of Cardiovascular Medicine III of Jiangbin Hospital of Guangxi Zhuang Autonomous Region were selected and divided into a nutrition group and a control group, with 100 cases in each group. The nutrition group received the coronary heart disease nutritional supplement treatment of the present invention, and the formula was consistent with that of Example 1. The measurement indicators included left ventricular ejection fraction (LVEF), N-terminal pro-B-type natriuretic peptide (NT-proBNP), New York heart function class (NYHA), hemoglobin (HB), total protein (TP), albumin (ALB), etc.

[0133] Comparative experimental results

[0134] index Nutrition group (n=100) Control group (n=100) Difference (P value) Increased LVEF 5.0±1.0％ 2.0±0.5％ <0.01 NT-proBNP decrease 500±200pg / mL 200±100pg / mL <0.01 NYHA class improvement Level 1 Up 0.5 level up <0.01 HB increase 1.2±0.5g / L 0.3±0.2g / L <0.01 TP increase 1.8±0.6g / L 0.4±0.2g / L <0.01 ALB increase 2.5±0.7g / L 0.6±0.3g / L <0.01

[0135] The results of this example show that the LVEF of the patients in the nutrition group increased significantly, indicating that the heart function was improved; the NT-proBNP level was significantly reduced, indicating that heart failure was effectively alleviated. In addition, the NYHA heart function classification of the patients in the nutrition group was improved, and the patients' exercise tolerance and quality of life were improved.

[0136] In terms of nutrition, the HB, TP and ALB of the patients in the nutrition group were significantly improved, indicating that the supplement effectively improved the malnutrition problem of the patients. The nutritional supplement for coronary heart disease of the present invention can play a significant therapeutic effect in patients with coronary heart disease and chronic heart failure, and improve the heart function and overall nutritional status of the patients.

[0137] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A nutritional supplement for coronary heart disease, characterized in that: The supplement consists of the following components: Functional active ingredient group: Nattokinase, red yeast rice powder; Basic nutritional support ingredient group: resistant dextrin, whole protein, whey protein, soluble dietary fiber, water-soluble vitamins; Auxiliary health maintenance ingredient group: theaflavins and mogrosides.

2. A nutritional supplement for coronary heart disease according to claim 1, characterized in that: The coronary heart disease nutritional supplement includes the specific content ranges of the following components: Nattokinase: 150-250FU / g; Red yeast rice powder: 1.5-2.5mg / g; Resistant dextrin: 0.35-0.6g / g; Theaflavin: 3.5-4.5mg / g; Mogroside: 3.5-4.5mg / g; Whole protein: 0.55-0.65g / g; Whey protein: 0.07-0.08g / g; Soluble dietary fiber: 0.035-0.04g / g; Water-soluble vitamins: 0.035-0.04g / g.

3. A nutritional supplement for coronary heart disease according to claim 2, characterized in that: The specific optimized formula of the coronary heart disease nutritional supplement is: Nattokinase: 200-220FU / g; Red yeast rice: 2mg / g; Resistant dextrin: 500mg / g; Theaflavins: 4mg / g; Mogroside: 4mg / g; Whole protein: 600mg / g; Whey protein: 75mg / g; Soluble dietary fiber: 37.5mg / g; Water-soluble vitamins: 37.5 mg / g.

4. A nutritional supplement for coronary heart disease according to claim 3, characterized in that: The content of the nattokinase is 4000±100FU per package, and its activity is maintained at more than 90% of the initial value in an environment of 20-40°C; the particle size of the red yeast rice powder is 10-30 microns, and the content of Monacolin K is 1.0%-1.2%; the moisture content of the resistant dextrin is controlled at ≤4%, and the solubility is 90%-95%; the purity of theaflavins is 90%-95%, and the particle diameter range is 5-15 microns; the sweetness of the mogroside is 180-200 times that of sucrose, and the solubility in water is 98%-100%.

5. A method for preparing a nutritional supplement for coronary heart disease, applied to the nutritional supplement for coronary heart disease according to any one of claims 1 to 4, characterized in that: The following steps are involved: S1. Raw material preparation: S1.

1. Weigh natto powder, red yeast rice powder, resistant dextrin, theaflavins, mogroside, whole protein, whey protein, soluble dietary fiber, and water-soluble vitamins, and conduct quality inspection on each raw material to ensure compliance with the standards; S1.

2. Check the activity of natto powder to ensure that its nattokinase content reaches 4000FU; S1.

3. Check the particle size of red yeast rice to ensure that the particle size is 10-30 microns; S1.

4. Place the natto powder in a sterile environment at a temperature of 30-40°C and a humidity of 5-10%, and sterilize it using ultraviolet sterilization or a low pressure of 70-100 Pascal for 15-30 minutes; S2. Drying treatment: Place the red yeast rice powder and theaflavins in a drying oven at 45°C ± 2°C for 2.5 hours, control the humidity at ≤10%, and ensure that the moisture content is controlled at ≤4%; S2.

1. Spread the red yeast rice powder evenly on the baking tray to ensure even drying; S2.

2. Perform constant temperature drying under low humidity conditions (humidity ≤ 10%); S3. Preliminary mixing: Put resistant dextrin, dried red yeast rice powder, theaflavins, whole protein, whey protein, soluble dietary fiber, and water-soluble vitamins into a mixer according to the proportions, and stir at room temperature for 10-15 minutes to form a preliminary mixture; S3.

1. Add the resistant dextrin into the mixer first according to the proportion order, and then gradually add red yeast rice powder and theaflavins; S3.2, stirring at 300-500 rpm for 15 minutes to ensure uniform mixing; S4. Addition of active ingredients: Add the processed natto powder and mogroside to the preliminary mixture and continue stirring for 10-20 minutes to ensure that the components are evenly distributed to form a uniform nutritional supplement powder; S5. Packaging: The evenly mixed powder is packaged into 20g pieces by automatic packaging equipment to ensure that each piece of product contains the same ingredients and dosage; S5.

1. Use precision packaging machines to ensure that the weight of each package is controlled within the range of 20g ± 0.05g; S5.

2. Automatically weigh and inspect, and remove packaging strips with an error greater than 0.1 gram; S6. Packaging and storage: S6.

1. Seal the subpackaged products in moisture-proof and light-proof aluminum foil bags to ensure product stability and shelf life; S6.

2. Store the packaged products in an environment with a temperature below 25°C and a humidity not exceeding 50%.

6. The method for preparing a nutritional supplement for coronary heart disease according to claim 5, characterized in that: The S1 raw material preparation step also includes the following detailed steps: S1a, store natto powder at 20-30°C to avoid loss of activity and keep its moisture content below 5%; S1b, screening the red yeast rice powder, resistant dextrin and theaflavins to ensure that their particle sizes are 10-30 μm, 200-500 μm and 5-15 μm respectively; S1c. Test the water solubility of mogroside to ensure that its solubility is above 98%.

7. The method for preparing a nutritional supplement for coronary heart disease according to claim 5, characterized in that: The S3 preliminary mixing step also includes the following refinement steps: S3a, first add the resistant dextrin into the mixer according to the proportion, and pre-mix at a low speed for 3 minutes; S3b, gradually add red yeast rice powder and theaflavins, increase the stirring speed to 350-450 rpm, and continue stirring for 10 minutes to ensure that all components are initially mixed evenly; S3c. During the initial mixing process, monitor the uniformity of the mixture to ensure that no particle sedimentation or powder separation occurs.

8. The method for preparing a nutritional supplement for coronary heart disease according to claim 5, characterized in that: The S5 packaging step also includes the following detailed steps: S5a, use automatic weighing equipment to ensure that the net weight of each package is 20g ± 0.05g, and products with errors exceeding the range will be automatically rejected; S5b. During the subpackaging process, use vacuum packaging equipment to seal to ensure that there is no air or moisture in the packaging process to avoid the loss of ingredient effectiveness; S5c. Pass the packaged products through X-ray inspection equipment one by one to ensure the integrity of the packaging, and remove products with damaged packaging or loose seals.

9. A use of a nutritional supplement for coronary heart disease according to any one of claims 1 to 4, characterized in that: The method of applying the coronary heart disease nutritional supplement obtained by the method for preparing the coronary heart disease nutritional supplement according to any one of claims 5 to 8 to daily nutritional support for patients with coronary heart disease comprises the following steps: a) taking the prepared nutritional supplement for coronary heart disease in divided doses of 20 grams per strip 2-3 times a day; b) Take it 30 minutes before meals with warm water, and avoid taking it with high-fat or high-sugar foods; c) One course of treatment is 3 months of continuous use, and the patient's health indicators should be monitored regularly.

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