Cardiac peptide red yeast rice tablet as well as preparation method and application thereof

Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly provides a cardiac peptide red yeast rice tablet as well as a preparation method and application thereof. The cardiac peptide red yeast rice tablet comprises the following components: cardiac peptide powder, soybean peptide powder, functional red yeast rice, D-mannitol, bovine heart peptide powder, microcrystalline cellulose, a compound nutrition enhancer and magnesium stearate. According to the cardiac peptide red yeast rice tablet disclosed by the invention, the components are used according to a specific ratio, so that the cardiac peptide red yeast rice tablet has the functions of preventing myocardial dysfunction caused by lipid metabolism disorder, improving myocardial contractility and increasing the survival rate of myocardial cells, and a product suitable for improving cardiac functions can be provided.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and particularly relates to a cardiac peptide red yeast rice tablet, its preparation method and application. Background Art

[0002] Cardiovascular and cerebrovascular diseases are collectively referred to as diseases of the heart blood vessels and cerebrovascular vessels, generally referring to ischemic or hemorrhagic diseases that occur in the heart, brain and whole body tissues caused by hyperlipidemia, blood viscosity, atherosclerosis, hypertension, etc. Cardiovascular and cerebrovascular diseases are common diseases that seriously threaten humans, especially the health of middle-aged and elderly people over 50 years old, and are characterized by high prevalence, high disability rate and high mortality rate. Even with the application of the most advanced and perfect treatment means, more than 50% of the survivors of cerebrovascular accidents still cannot take care of themselves completely. The number of people who die from cardiovascular and cerebrovascular diseases worldwide each year is as high as 15 million, ranking first among various causes of death.

[0003] In recent years, with the rapid pace of life, the pressure of family and career is increasing, and people's emotions are becoming more and more unstable. At the same time, excessive drinking, too much dietary fat intake, lack of necessary exercise, combined with environmental pollution, the content of negative ions in the air has dropped sharply, and the intake of negative ions in the body is insufficient. These factors directly lead to a slowdown in the body's metabolism, a slowdown in blood flow rate, a rapid increase in blood viscosity, resulting in insufficient blood supply to the heart and brain. If not prevented and conditioned in time, it will cause cardiovascular and cerebrovascular diseases such as coronary heart disease, hypertension, and cerebral thrombosis. Therefore, people pay more and more attention to cardiovascular and cerebrovascular management, and the market demand for developing new products to improve heart function has also increased accordingly. Summary of the Invention

[0004] In view of this, the present invention aims to provide a cardiac peptide red yeast rice tablet, so as to provide a product suitable for improving heart function.

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

[0006] A cardiac peptide red yeast rice tablet, the components of the cardiac peptide red yeast rice tablet include myocardial peptide powder, soy peptide powder, functional red yeast rice, D-mannitol, bovine cardiac peptide powder, microcrystalline cellulose, compound nutritional fortifier and magnesium stearate.

[0007] Further, the weight percentages of each component in the cardiac peptide red yeast rice tablet are respectively 13% - 18% of myocardial peptide powder, 5% - 30% of soy peptide powder, 5% - 20% of functional red yeast rice, 5% - 30% of D-mannitol, 5% - 20% of bovine cardiac peptide powder, 5% - 20% of microcrystalline cellulose, 5% - 10% of compound nutritional fortifier, and 1% - 5% of magnesium stearate.

[0008] Further, the components of the compound nutritional fortifier include maltodextrin, vitamin B1, vitamin B2, and vitamin B6.

[0009] Compared with the prior art, the present invention has the following advantages:

[0010] The cardiac peptide red yeast rice tablets of the present invention, through its component composition, the functional red yeast rice in the components contains monacolin K, which can reduce the synthesis of liver cholesterol by inhibiting HMG-CoA reductase and reduce the deposition of lipids on the blood vessel wall. At the same time, the cardiac peptide powder activates the AMPK signaling pathway, promotes the fatty acid β-oxidation of cardiomyocytes, and prevents lipotoxic myocardial injury. Based on the above introduction, the functional red yeast rice can reduce the circulating blood lipid level, and the cardiac peptide can enhance the myocardial lipid utilization efficiency. The two work synergistically to jointly prevent myocardial dysfunction caused by lipid metabolism disorders.

[0011] In addition, the cardiac peptide powder can protect the electron transfer functions of mitochondrial complex I and mitochondrial complex III by providing anserine, thereby reducing ROS leakage. The functional red yeast rice promotes mitochondrial biogenesis and increases ATP generation efficiency by upregulating the SIRT1 / PGC-1α pathway. The combined application of the two can increase the ATP content of cardiomyocytes and improve myocardial contractility.

[0012] Meanwhile, the coenzyme Q10 precursor and cytochrome C fragment contained in the bovine cardiac peptide powder in the components can participate in the electron transport chain to improve ATP generation efficiency, and the specific myocardial nutrient factor contained in the bovine cardiac peptide powder can increase the survival rate of cardiomyocytes by activating the PI3K / Akt signaling pathway.

[0013] Therefore, through the specific ratio of the above components, the cardiac peptide red yeast rice tablets of the present invention have the functions of preventing myocardial dysfunction caused by lipid metabolism disorders, improving myocardial contractility, and increasing the survival rate of cardiomyocytes, thereby improving the problems of human cardiovascular and cerebrovascular aspects.

[0014] At the same time, the present invention also provides a preparation method of the above cardiac peptide red yeast rice tablets, which includes:

[0015] Premix the cardiac peptide powder, the soybean peptide powder, the functional red yeast rice, the D-mannitol, the bovine cardiac peptide powder and the microcrystalline cellulose to obtain a premixed powder;

[0016] Mix the premixed powder with a binder to obtain wet granules;

[0017] Dry the wet granules to obtain dry granules;

[0018] Mix the dry granules, the compound nutritional fortifier and the magnesium stearate to obtain a total mixed powder;

[0019] Press the total mixed powder into tablets to obtain the cardiac peptide red yeast rice tablets.

[0020] Further, the adhesive is ethanol with a volume fraction of 95%.

[0021] Further, the drying temperature of the wet granules is between 40°C and 60°C.

[0022] Further, the moisture content of the dried granules is ≤ 7.5%.

[0023] The preparation method of the Xin Tai Hong Qu tablets in this embodiment adopts wet granulation, with a simple process and easy operation, which is conducive to industrial production.

[0024] Another object of the present invention is to propose an application of the above-mentioned Xin Tai Hong Qu tablets, and the Xin Tai Hong Qu tablets are used for preparing functional foods, health products or drugs.

[0025] Further, the functional food is used to improve immunity or cardiac function; and / or,

[0026] The health product is used to improve immunity or cardiac function; and / or,

[0027] The drug is used to improve immunity or cardiac function.

[0028] Further, the cardiac function includes promoting myocardial cell metabolism and protecting myocardial cells from free radical damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] 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 of the present invention. In the drawings:

[0030] Figure 1 is a flow chart of the preparation method of the Xin Tai Hong Qu tablets of the present invention;

[0031] Figure 2 is a graph showing the effects of Example 1, Comparative Example 1 and Comparative Example 2 of the present invention on the survival rate of myocardial cells. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0032] It should be noted that, without conflict, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0033] 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 the reagents or instruments whose manufacturers are not specified, they can all be obtained by purchasing commercially available conventional products. For the technical means or process methods involved, if the specific conditions are not written, they can be carried out according to the existing methods in the field.

[0034] Here, it should also be noted that in order to avoid obscuring the present invention due to unnecessary details, only the results closely related to the solution of the present invention are shown in the drawings, while other details less related to the present invention are omitted. The present invention will be described in detail below with reference to the drawings and in conjunction with embodiments.

[0035] This embodiment relates to a Xinpeihongqu tablet, which can provide new development for products that improve heart function.

[0036] In terms of the overall design, the components of the Xinpeihongqu tablet in this embodiment include myocardial peptide powder, soy peptide powder, functional red yeast rice, D-mannitol, bovine cardiac peptide powder, microcrystalline cellulose, compound nutritional fortifier, and magnesium stearate.

[0037] Specifically, the myocardial peptide powder in the above components is a protein polypeptide preparation with antioxidant properties, which can scavenge free radicals and protect the mitochondrial function of myocardial cells. Myocardial peptide powder can inhibit the apoptosis pathway of myocardial cells (such as the Bcl-2 / Bax pathway) by regulating calcium ion channels and improve myocardial metabolism.

[0038] In addition, myocardial peptide powder can also promote the fatty acid β-oxidation of myocardial cells by activating the AMPK signaling pathway and prevent lipotoxic myocardial injury. In addition, it can also protect the electron transfer function of mitochondrial complex Ⅰ and Ⅲ by providing carnosine and reduce ROS leakage.

[0039] The soy peptide powder in the components is a mixed peptide product composed of 2-6 amino acids with a molecular weight of 200-800 Dalton. The peptides contained in it are small molecule peptides, which can be rapidly absorbed through the intestinal oligopeptide transport system (PEPT1), and the bioavailability is higher than that of intact proteins. In addition, the amino acids contained in soy peptide powder can provide essential amino acids (such as branched-chain amino acids) for the human body and support muscle anabolism. Therefore, soy peptide powder has the functions of protein supplementation and metabolic regulation.

[0040] The functional red yeast rice in the components is a red or purple rice koji obtained by inoculating liquid Monascus strains on a rice matrix and undergoing solid-state fermentation. During the fermentation process of red yeast rice, various metabolites beneficial to the human body are produced, such as ergosterol, lovastatin, and enzymes and other active substances that can block cholesterol biosynthesis and play a lipid-lowering role.

[0041] At the same time, functional red yeast rice can also promote mitochondrial biosynthesis and increase the ATP generation efficiency by upregulating the SIRT1 / PGC-1α pathway. In addition, the red yeast pigment in functional red yeast rice can regulate lipid metabolism through the PPARγ pathway and reduce the oxidative susceptibility of LDL.

[0042] D-mannitol in the components is a multifunctional excipient, a low-calorie sweetener (0.6 times the sweetness of sucrose), and is suitable for diabetic groups. D-mannitol can act as a pore-forming agent in tablets through its high osmotic pressure characteristics, improving the disintegration of tablets.

[0043] The bovine heart peptide powder in the components contains coenzyme Q10 precursors and cytochrome C fragments, which can participate in the electron transport chain to improve the efficiency of ATP generation. And the bovine heart peptide powder also contains specific myocardial nutritional factors, which can improve the survival rate of cardiomyocytes by activating the PI3K / Akt signaling pathway. Therefore, the bovine heart peptide powder has the effect of protecting the cardiovascular system.

[0044] The main component of microcrystalline cellulose in the components is a linear polysaccharide substance bound by β-1,4-glucoside bonds, which can form a three-dimensional porous structure through a hydrogen bond network, improving the tensile strength of tablets. In the wet granulation of the present invention, microcrystalline cellulose can be used as a dry binder to improve the fluidity of granules.

[0045] The compound nutritional fortifier in the components refers to one or more nutrients added to the product according to nutritional needs, which can improve the nutritional value of the product. In this embodiment, it is used as a precise nutritional supplement.

[0046] Magnesium stearate in the components is an organic compound with a slippery feeling when in contact with the skin. It is a classic lubricant that can reduce the friction between particles through a hydrophobic film. Therefore, the granules made with it have good fluidity and compressibility. In this embodiment, it is used as a lubricant.

[0047] Therefore, through the combined use of the above components in this embodiment, the Xin Tai Hong Qu tablets have the functions of preventing myocardial dysfunction caused by lipid metabolism disorders, improving myocardial contractility, and increasing the survival rate of cardiomyocytes, thereby improving problems in the human cardiovascular and cerebrovascular aspects.

[0048] It should be noted that based on the above overall component composition, further, in specific implementation, the weight percentages of the components in the Xin Tai Hong Qu tablets of this embodiment can be, for example, 13% - 18% for myocardial peptide powder, 5% - 30% for soybean peptide powder, 5% - 20% for functional red yeast rice, 5% - 30% for D-mannitol, 5% - 20% for bovine heart peptide powder, 5% - 20% for microcrystalline cellulose, 5% - 10% for compound nutritional fortifier, and 1% - 5% for magnesium stearate.

[0049] It is worth noting that as a preferred implementation form, the components of the above compound nutritional fortifier can include, for example, maltodextrin, vitamin B1, vitamin B2, and vitamin B6.

[0050] Among them, maltodextrin is a polysaccharide food raw material, a low-conversion product between starch and starch sugar, which is extremely easy to be absorbed by the human body and is especially suitable as the basic raw material for patient and infant foods. In addition, maltodextrin also contains trace elements and minerals beneficial to the human body such as calcium and iron, which can promote the normal material metabolism of the human body. It is a component of the compound nutritional fortifier in this embodiment.

[0051] At the same time, the above-mentioned vitamin B1, also known as thiamine or antineuritic vitamin, is synthesized by fungi, microorganisms and plants, and animals and humans can only obtain it from food, and it has the function of maintaining normal carbohydrate metabolism. It is a component of the compound nutritional fortifier in this embodiment.

[0052] Vitamin B2, also known as riboflavin, is a component of the prosthetic group of flavin enzymes in the body, can participate in the growth metabolism of cells, is an essential nutrient for the metabolism and repair of body tissues, can also participate in the metabolism of vitamin B6 and niacin, and is a model of the coordinated action of B vitamins. It is a component of the compound nutritional fortifier in this embodiment.

[0053] Vitamin B6, also known as pyridoxine or pyridoxol, participates in a variety of biochemical reactions in cells as a coenzyme factor, such as the synthesis, interconversion and degradation of amino acids, and can affect the normal metabolism of proteins and amino acids. From the above introduction, it can be seen that vitamin B6 can participate in homocysteine metabolism, and homocysteine is a sulfur-containing amino acid formed in the methionine metabolic pathway, is an important intermediate product of energy metabolism and many methylation reactions, and is also an independent or related risk factor for atherosclerosis, acute myocardial infarction, stroke, coronary artery disease and peripheral vascular disease, etc., while vitamin B6 can reduce the content of homocysteine in plasma and reduce the risk of cardiovascular diseases. It is a component of the compound nutritional fortifier in this embodiment and can reduce the risk of cardiovascular diseases.

[0054] In this embodiment, based on the above introduction of the composition of the Xinpei Hongqu tablets, in specific implementation, an exemplary preparation method of the above-mentioned Xinpei Hongqu tablets, combined with Figure 1 as shown, specifically includes the following steps:

[0055] Step S1: Premix myocardial peptide powder, soybean peptide powder, functional red yeast rice, D-mannitol, bovine cardiac peptide powder and microcrystalline cellulose to obtain a premixed powder.

[0056] In the above step S1, the premixing of myocardial peptide powder, soybean peptide powder, functional red yeast rice, D-mannitol, bovine cardiac peptide powder and microcrystalline cellulose, as a preferred implementation form, for example, can be dry mixing the above components for a preset time.

[0057] Step S2: Mix the premixed powder with a binder to obtain wet granules.

[0058] In the above step S2, the binder used is preferably ethanol with a volume fraction of 95%. In this step, 95% ethanol used as a binder is beneficial to wet the drug and facilitate granulation, and can also facilitate the dissolution of the drug by improving its wettability, making it a good binder for one-step granulation.

[0059] For the above step 2, the premixed powder is mixed with the binder to obtain wet granules. Specifically, in an exemplary implementation form, for example, the premixed powder can be mixed and stirred evenly with 95% ethanol, and then granulated through a 20-mesh sieve to obtain wet granules.

[0060] Among them, the mass of the added 95% ethanol is preferably, for example, 25% of the total amount of the premixed powder.

[0061] Step S3: Dry the wet granules to obtain dry granules.

[0062] The drying temperature of the above wet granules is preferably, for example, between 40°C and 60°C.

[0063] The moisture content of the above dry granules is preferably, for example, controlled within the range of ≤7.5%.

[0064] Step S4: Mix the dry granules, compound nutritional fortifier and magnesium stearate to obtain a total mixed powder.

[0065] Step S5: Press the total mixed powder to obtain Xin Tai Hong Qu tablets.

[0066] The tablet weight of the Xin Tai Hong Qu tablets in the above step S5 is preferably, for example, 0.5 g / tablet, and the weight difference limit requirement is ±5%.

[0067] According to the above introduction, the preparation method of Xin Tai Hong Qu tablets in this embodiment adopts wet granulation, with a simple process and convenient operation, which is conducive to industrial production.

[0068] In addition, this embodiment also relates to the application of the above Xin Tai Hong Qu tablets. Specifically, the Xin Tai Hong Qu tablets in this embodiment are used to prepare functional foods, health products or drugs.

[0069] Among them, the above functional foods can be used, for example, to improve immunity or heart function.

[0070] The above health products can be used, for example, to improve immunity or heart function.

[0071] The above drugs can be used, for example, to improve immunity or heart function.

[0072] Specifically, the above heart function can include, for example, promoting myocardial cell metabolism and protecting myocardial cells from free radical damage.

[0073] Based on the above introduction, for the Cardiotide Hongqu Tablets of the present invention and its preparation method and uses, further, in specific implementation, the following preparation examples can be referred to.

[0074] Example 1

[0075] This Example 1 is for preparing the above-mentioned Cardiotide Hongqu Tablets, and the specific preparation steps are as follows:

[0076] Step S1: Dry-mix 18 g of myocardial peptide powder, 18 g of soy peptide powder, 16 g of functional red yeast rice, 16 g of D-mannitol, 13 g of bovine heart peptide powder, and 13 g of microcrystalline cellulose for 3 minutes to obtain a premixed powder.

[0077] Step S2: Add 95% ethanol (the amount of 95% ethanol accounts for 25% of the total amount of granulating materials) to the premixed powder, start the machine to stir evenly, and then granulate through a 20-mesh sieve to obtain wet granules.

[0078] Step S3: Put the wet granules into an oven and dry at 40°C, then screen them to control the moisture content at ≤7.5% to obtain dry granules.

[0079] Step S4: Mix the dry granules with 5 g of compound nutritional fortifier (maltodextrin, vitamin B1, vitamin B2, vitamin B6) and 1 g of magnesium stearate to obtain a total mixed powder.

[0080] Step S5: Load the total mixed material into a tableting machine for tableting, with a tablet weight of 0.5 g / tablet, and regularly check the difference in filling amount (the weight difference limit requirement is ±5%) to obtain Cardiotide Hongqu Tablets.

[0081] Example 2

[0082] This Example 2 is for preparing the above-mentioned Cardiotide Hongqu Tablets, and the specific preparation steps are as follows:

[0083] Step S1: Dry-mix 8 g of myocardial peptide powder, 28 g of soy peptide powder, 16 g of functional red yeast rice, 16 g of D-mannitol, 13 g of bovine heart peptide powder, and 13 g of microcrystalline cellulose for 3 minutes to obtain a premixed powder.

[0084] Step S2: Add 95% ethanol (the amount of 95% ethanol accounts for 25% of the total amount of granulating materials) to the premixed powder, start the machine to stir evenly, and then granulate through a 20-mesh sieve to obtain wet granules.

[0085] Step S3: Put the wet granules into an oven and dry at 40°C, then screen them to control the moisture content at ≤7.5% to obtain dry granules.

[0086] Step S4: Mix the dry granules with 5 g of compound nutritional fortifier (maltodextrin, vitamin B1, vitamin B2, vitamin B6) and 1 g of magnesium stearate to obtain a total mixed powder.

[0087] Step S5: Load the total mixed material into a tabletting machine for tabletting. The tablet weight is 0.5 g / tablet. Regularly check the difference in filled quantity (the weight difference limit requirement is ±5%), and obtain the Xin Tai Hong Qu tablets.

[0088] Example 3

[0089] This Example 3 is for preparing the above-mentioned Xin Tai Hong Qu tablets. The specific preparation steps are as follows:

[0090] Step S1: Dry mix 18 g of myocardial peptide powder, 28 g of soy peptide powder, 6 g of functional red yeast rice, 16 g of D-mannitol, 13 g of bovine heart peptide powder, and 13 g of microcrystalline cellulose for 3 minutes to obtain a premixed powder.

[0091] Step S2: Add 95% ethanol (the amount of 95% ethanol accounts for 25% of the total amount of granulating materials) to the premixed powder. After starting the machine and stirring evenly, granulate through a 20-mesh sieve to obtain wet granules.

[0092] Step S3: Put the wet granules into an oven and dry at 40°C, then screen them to control the moisture content at ≤7.5% to obtain dry granules.

[0093] Step S4: Mix the dry granules with 5 g of compound nutritional fortifier (maltodextrin, vitamin B1, vitamin B2, vitamin B6) and 1 g of magnesium stearate to obtain a total mixed powder.

[0094] Step S5: Load the total mixed material into a tabletting machine for tabletting. The tablet weight is 0.5 g / tablet. Regularly check the difference in filled quantity (the weight difference limit requirement is ±5%), and obtain the Xin Tai Hong Qu tablets.

[0095] Example 4

[0096] This Example 4 is for preparing the above-mentioned Xin Tai Hong Qu tablets. The specific preparation steps are as follows:

[0097] Step S1: Dry mix 8 g of myocardial peptide powder, 18 g of soy peptide powder, 16 g of functional red yeast rice, 26 g of D-mannitol, 13 g of bovine heart peptide powder, and 13 g of microcrystalline cellulose for 3 minutes to obtain a premixed powder.

[0098] Step S2: Add 95% ethanol (the amount of 95% ethanol accounts for 25% of the total amount of granulating materials) to the premixed powder. After starting the machine and stirring evenly, granulate through a 20-mesh sieve to obtain wet granules.

[0099] Step S3: Put the wet granules into an oven and dry at 40°C, then screen them to control the moisture content at ≤7.5% to obtain dry granules.

[0100] Step S4: Mix the dry granules with 5 g of compound nutritional fortifier (maltodextrin, vitamin B1, vitamin B2, vitamin B6) and 1 g of magnesium stearate to obtain a total mixed powder.

[0101] Step S5: Load the total mixed material into a tableting machine for tableting, with a tablet weight of 0.5 g / tablet. Regularly check the difference in filling amount (the weight difference limit requirement is ±5%), and obtain the Xin Tai Hong Qu tablets.

[0102] Example 5

[0103] This Example 5 is for preparing the above-mentioned Xin Tai Hong Qu tablets, and the specific preparation steps are as follows:

[0104] Step S1: Dry mix 18 g of myocardial peptide powder, 18 g of soy peptide powder, 6 g of functional red yeast rice, 26 g of D-mannitol, 13 g of bovine heart peptide powder, and 13 g of microcrystalline cellulose for 3 minutes to obtain a premixed powder.

[0105] Step S2: Add 95% ethanol (the amount of 95% ethanol accounts for 25% of the total amount of granulating materials) to the premixed powder. After starting the machine and stirring evenly, granulate through a 20-mesh sieve to obtain wet granules.

[0106] Step S3: Put the wet granules into an oven and dry at 40°C, then screen the granules, and control the moisture content to ≤7.5% to obtain dry granules.

[0107] Step S4: Mix the dry granules with 5 g of compound nutritional fortifier (maltodextrin, vitamin B1, vitamin B2, vitamin B6) and 1 g of magnesium stearate to obtain a total mixed powder.

[0108] Step S5: Load the total mixed material into a tableting machine for tableting, with a tablet weight of 0.5 g / tablet. Regularly check the difference in filling amount (the weight difference limit requirement is ±5%), and obtain the Xin Tai Hong Qu tablets.

[0109] Example 6

[0110] This Example 6 is for preparing the above-mentioned Xin Tai Hong Qu tablets, and the specific preparation steps are as follows:

[0111] Step S1: Dry mix 18 g of myocardial peptide powder, 18 g of soy peptide powder, 16 g of functional red yeast rice, 19 g of D-mannitol, 13 g of bovine heart peptide powder, and 13 g of microcrystalline cellulose for 3 minutes to obtain a premixed powder.

[0112] Step S2: Add 95% ethanol (the amount of 95% ethanol accounts for 25% of the total amount of granulating materials) to the premixed powder. After starting the machine and stirring evenly, granulate through a 20-mesh sieve to obtain wet granules.

[0113] Step S3: Put the wet granules into an oven and dry at 40°C, then screen the granules, and control the moisture content to ≤7.5% to obtain dry granules.

[0114] Step S4: Mix the dry granules with 3 g of compound nutritional fortifier (maltodextrin, vitamin B1, vitamin B2, vitamin B6) and 1 g of magnesium stearate to obtain a total mixed powder.

[0115] Step S5: Load the total mixed material into a tabletting machine for tabletting. The tablet weight is 0.5 g / tablet. Regularly check the difference in filled quantity (the weight difference limit requirement is ±5%), and obtain the Xin Tai Hong Qu tablets.

[0116] Comparative Example 1

[0117] This Comparative Example 1 is for preparing myocardial peptide powder tablets without functional red yeast rice. The specific preparation steps are as follows:

[0118] Step S1: Mix 34 g of myocardial peptide powder, 18 g of soy peptide powder, 16 g of D-mannitol, 13 g of bovine heart peptide powder, and 13 g of microcrystalline cellulose for 3 minutes to obtain a premixed powder.

[0119] Step S2: Add 95% ethanol (the amount of 95% ethanol accounts for 25% of the total amount of granulating materials) to the premixed powder. After starting the machine and stirring evenly, granulate through a 20-mesh sieve to obtain wet granules.

[0120] Step S3: Put the wet granules into an oven and dry at 40°C, then screen the granules. Control the moisture content at ≤7.5% to obtain dry granules.

[0121] Step S4: Mix the dry granules with 5 g of a compound nutritional fortifier (maltodextrin, vitamin B1, vitamin B2, vitamin B6) and 1 g of magnesium stearate to obtain a total mixed powder.

[0122] Step S5: Load the total mixed material into a tabletting machine for tabletting. The tablet weight is 0.5 g / tablet. Regularly check the difference in filled quantity (the weight difference limit requirement is ±5%), and obtain the myocardial peptide powder tablets.

[0123] Comparative Example 2

[0124] This Comparative Example 2 is for preparing functional red yeast rice tablets without myocardial peptide powder. The specific preparation steps are as follows:

[0125] Step S1: Mix 18 g of soy peptide powder, 34 g of functional red yeast rice, 16 g of D-mannitol, 13 g of bovine heart peptide powder, and 13 g of microcrystalline cellulose for 3 minutes to obtain a premixed powder.

[0126] Step S2: Add 95% ethanol (the amount of 95% ethanol accounts for 25% of the total amount of granulating materials) to the premixed powder. After starting the machine and stirring evenly, granulate through a 20-mesh sieve to obtain wet granules.

[0127] Step S3: Put the wet granules into an oven and dry at 40°C, then screen the granules. Control the moisture content at ≤7.5% to obtain dry granules.

[0128] Step S4: Mix the dried granules with 5 g of compound nutritional fortifier (maltodextrin, vitamin B1, vitamin B2, vitamin B6) and 1 g of magnesium stearate to obtain the total mixed powder.

[0129] Step S5: Load the total mixed material into a tabletting machine for tabletting. The tablet weight is 0.5 g / tablet. Regularly check the difference in filling amount (the limit requirement for weight difference is ±5%), and obtain the functional monascus rice tablets.

[0130] Verification example

[0131] In this verification example, by measuring the effects of the cardiac peptide monascus tablets prepared in Example 1, the myocardial peptide powder tablets prepared in Comparative Example 1, and the functional monascus rice tablets prepared in Comparative Example 2 on the survival rate of H9c2 cardiomyocytes after DOX injury, the protective effects of the two components of cardiac peptide and functional monascus rice on cardiomyocytes were verified.

[0132] For the above evaluation method of cardiomyocyte protection ability, the specific operation steps are as follows:

[0133] Take H9c2 cardiomyocytes in the logarithmic growth phase. After digestion with 0.25% trypsin, inoculate them into a 96-well plate at a cell concentration of 1×10 8 ·L -1 , 100 μL per well. After incubation for 24 h, group them, and set 6 replicate wells for each group.

[0134] Dissolve and dilute the myocardial peptide powder tablets, functional monascus rice tablets, and cardiac peptide monascus tablets with a methanol aqueous solution with a volume fraction of 70% to a sample concentration of 100 μg / mL to obtain a sample solution. Take 100 μL of the sample solution and add it to a 96-well enzyme-linked immunosorbent assay (ELISA) plate. After pretreatment for 6 h, 8 h, and 12 h, add DOX (final concentration of 1 μmol·L -1 ) simultaneously with the model group, and continue to culture for 24 h. Then, add 10 μL of 5 g·L -1 MTT solution to each well. After 4 h, aspirate the culture medium, add 150 μL of DMSO, and shake it gently on a shaker at a low speed for 10 min to fully dissolve the crystals. Then, measure the absorbance at 570 nm, calculate the cell survival rate, and use a methanol solution with a volume fraction of 70% instead of the sample as the blank (Ac). Calculate the cell survival rate according to the following formula: Cell survival rate = absorbance value of the experimental group / absorbance value of the normal control group × 100%.

[0135] In the above evaluation method of cardiomyocyte protection ability, the DOX used is doxorubicin, a cytotoxic drug with cardiotoxicity that can cause heart failure and is used to prepare a model of damaged H9c2 cardiomyocytes in this evaluation method.

[0136] In addition, the MTT solution used in the above evaluation method is thiazolyl blue solution. This evaluation method utilizes the succinate dehydrogenase in cell mitochondria to reduce exogenous MTT to water-insoluble blue-violet crystalline formazan, which deposits in cells, while dead cells do not have this function, thus distinguishing viable cardiomyocytes. At the same time, DMSO (dimethyl sulfoxide) is also used to dissolve the formazan in cells, and the dissolved formazan can be measured for its light absorption value at a wavelength of 570 nm with an enzyme-linked immunosorbent detector to indirectly reflect the number of viable cardiomyocytes.

[0137] The verification results of this verification example are as Figure 1 shown. According to Figure 1 it can be seen that myocardial peptide powder tablets, functional red yeast rice tablets, and heart peptide red yeast tablets can all improve the survival rate of cardiomyocytes and have the ability to protect cardiomyocytes.

[0138] In addition, through Figure 1 it can also be seen that for the cardiomyocytes pretreated with the sample solution of heart peptide red yeast tablets for 6 h, their survival rate after adding DOX damage is above 75%. As the pretreatment time of the sample solution of heart peptide red yeast tablets for cardiomyocytes increases, the survival rate of cardiomyocytes also increases. The survival rate of cardiomyocytes after pretreatment for 18 h can reach 90%. However, for the cardiomyocytes pretreated with the sample solutions of myocardial peptide powder tablets and functional red yeast rice tablets for 18 h, their survival rates after adding DOX damage do not exceed 75%.

[0139] Thus, it can be seen that the ability of heart peptide red yeast tablets to protect cardiomyocytes is superior to that of myocardial peptide powder tablets and functional red yeast rice tablets, proving that the combined use of myocardial peptide and functional red yeast has a better ability to protect cardiomyocytes than the use of a single component.

[0140] In summary, the heart peptide red yeast tablets in this example, through the specific ratio use of the above various components, have a better ability to protect cardiomyocytes compared to a single component, and can prevent myocardial dysfunction caused by lipid metabolism disorders and improve myocardial contractility, thereby improving problems in the human heart function and providing new development for products to improve heart function. In addition, from Figure 1 it can be seen that the preparation method of the heart peptide red yeast tablets in this embodiment is simple in process and convenient in operation, which is conducive to industrial production.

[0141] 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 heart peptide red yeast rice tablet, characterized in that: The components of the cardiopeptide red yeast rice tablets include cardiopeptide powder, soybean peptide powder, functional red yeast rice, D-mannitol, bovine cardiopeptide powder, microcrystalline cellulose, a compound nutritional enhancer and magnesium stearate.

2. The heart peptide red yeast rice tablet according to claim 1, characterized in that: The weight percentages of the components in the cardiopeptide red yeast rice tablets are respectively 13% to 18% of cardiopeptide powder, 5% to 30% of soybean peptide powder, 5% to 20% of functional red yeast rice, 5% to 30% of D-mannitol, 5% to 20% of bovine cardiopeptide powder, 5% to 20% of microcrystalline cellulose, 5% to 10% of compound nutritional enhancer, and 1% to 5% of magnesium stearate.

3. The heart peptide red yeast rice tablet according to claim 1 or 2, characterized in that: The components of the compound nutritional enhancer include maltodextrin, vitamin B1, vitamin B2 and vitamin B6.

4. The method for preparing the heart peptide red yeast rice tablets according to any one of claims 1 to 3, characterized in that: The preparation method comprises: Premixing the myocardial peptide powder, the soybean peptide powder, the functional red yeast rice, the D-mannitol, the oxcardial peptide powder and the microcrystalline cellulose to prepare a premixed powder; mixing the premixed powder with a binder to obtain wet granules; drying the wet granules to obtain dry granules; The dry particles, the compound nutritional enhancer and the magnesium stearate are mixed to prepare a total mixed powder; The total mixed powder is tableted to prepare the atrial peptide red yeast rice tablets.

5. The method for preparing the heart peptide red yeast rice tablet according to claim 4, characterized in that: The adhesive is 95% ethanol by volume.

6. The method for preparing the heart peptide red yeast rice tablets according to claim 4, characterized in that: The drying temperature of the wet granules is between 40°C and 60°C.

7. The method for preparing the heart peptide red yeast rice tablets according to claim 4, characterized in that: The moisture content of the dried particles is ≤7.5%.

8. The use of the Xinpihongqu tablets according to any one of claims 1 to 3, characterized in that: The heart peptide red yeast rice tablet is used for preparing functional food, health care product or medicine.

9. The use of the Xinpihongqu tablets according to claim 8, characterized in that: The functional food is used to enhance immunity or improve heart function; and / or, The health care product is used to enhance immunity or improve heart function; and / or, The medicine is used to enhance immunity or improve heart function.

10. The use of the Xinpihongqu tablets according to claim 9, characterized in that: The cardiac functions include promoting myocardial cell metabolism and protecting myocardial cells from free radical damage.

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