CN111466565A

CN111466565A - Sea cucumber peptide formula food with special medical application and preparation method thereof

Info

Publication number: CN111466565A
Application number: CN202010285997.5A
Authority: CN
Inventors: 曾庆桂; 马龙
Original assignee: Guangzhou Cishan Biotechnology Co ltd
Current assignee: Guangzhou Cishan Biotechnology Co ltd
Priority date: 2020-04-13
Filing date: 2020-04-13
Publication date: 2020-07-31

Abstract

The invention discloses a sea cucumber peptide formula food with special medical application, in particular to a food composition with the function of controlling the blood sugar of type II diabetes. The formula food for special medical application comprises the following components: a) a mitochondrial nutrient; b) sea cucumber peptides; c) medicinal and edible nutritional components; d) a natural sweetener. The mitochondrial nutrient is a nutrient which can protect the structural integrity of mitochondria or promote the exertion of mitochondrial function, and at least comprises the combination of coenzyme Q10 and lipoic acid. The components of the invention cooperate with each other to promote the regeneration of mitochondria, promote the repair of islet cells and restore the immune function and the cell metabolism function. In addition, the invention has the effect of burning fat, can eliminate toxin wrapped by the fat in vivo and can eliminate free radicals in cells. The invention also has the effects of restoring blood sugar control, balancing and stabilizing blood sugar, eliminating the side effect of hypoglycemic drugs and avoiding the occurrence of diabetic complications.

Description

Sea cucumber peptide formula food with special medical application and preparation method thereof

Technical Field

The invention relates to a sea cucumber peptide formula food with special medical application and a preparation method thereof, in particular to a food composition with the special medical application formula and a preparation method thereof, wherein the food composition has the function of controlling the blood sugar of type II diabetes.

Background

The number of diabetes patients is continuously increasing in the global scope, and according to statistics, the incidence rate accounts for less than 1% in the last 80 th century, 4% in the 90 th century, 7% in the 2000 th century and 11% in the 2010 th. The number of the affected people in the world in 2017 is about 4.25 hundred million, and is predicted to reach 6.29 hundred million by 2045 years. China is the country with the most diabetes in the world, and the incidence rate is 0.67% in the 80 s and 11.6% in the 2013 s from the aspect of incidence rate. From the diabetes population, 1.14 billion in 2017, about 1.5 billion in 2045 is expected. The short term is more than 30 years, and the Chinese incidence rate is increased by 17.3 times. The clinical medicines are more and more, and the incidence rate is higher and higher.

At present, Western medicine clinical treatment of type II diabetes (hereinafter referred to as T2DM) depends on 8 types, which are divided into 1-4 lines of medicines, including oral hypoglycemic drugs and exogenous insulin injection for treatment. Each of the above drugs can control only 0.5-1.5% of glycosylated hemoglobin. A problem often faced during treatment is that of first-line drugs, such as: after the metformin is used for about one year, an organism gradually shows drug resistance, the blood sugar control does not reach the standard (the glycosylated hemoglobin is taken as an index and cannot be controlled below 6.5 percent), a second-line medicament is used, and by analogy, 1-4-line oral hypoglycemic medicaments cannot be used for controlling the blood sugar generally in 3-5 years, and only insulin can be injected. Insulin starts at a low dose and increases as blood glucose slowly rises. Around 10 years, insulin injections also lose their effectiveness, a stage that is essentially complicated by various "diabetic complications" such as diabetic foot, nerve damage, angiosclerosis, visual deterioration (cataracts), renal failure, etc. Complications caused by diabetes mellitus are inevitable and increasingly serious.

Oral hypoglycemic agents are often associated with side effects. The side effects are usually initially manifested as decreased appetite, cold and soft hands and feet, dizziness and headache, abdominal distension, diarrhea, constipation. Then, uneasiness of sleeping at night, skin itching, obvious rise of blood fat and blood pressure, palpitation, chest distress, tinnitus, blurred thinking, memory decline and hypodynamia slowly occur; then, the patient feels light and desire, edema, impaired liver and kidney functions, unconsciousness of the skin, dizziness, headache, vomiting, abdominal pain and blurred vision. Finally, the diabetic complications such as heart failure, myocardial infarction, cerebral infarction, apoplexy, cataract, foot rot, and non-healing of wounds of the whole body can be achieved.

Since its discovery in 1921, insulin was considered a first line drug for the treatment of diabetes. However, in the last 70-80 years of the century, insulin was found to be effective only in type I diabetes, and very limited in type II diabetes. In order to more effectively control the blood sugar of type II diabetes, sulfonylureas are subsequently clinically used as first-line drugs for type II diabetes, since they promote insulin secretion. However, sulfonylureas were subsequently found to have too strong side effects and no control effect for more than 5 years of diabetes. In the 80 s, metformin substituted sulfonylureas is a new "first-line oral hypoglycemic agent". The existing metformin is artificially modified and synthesized, so that the toxicity is reduced but not eliminated. The maximum amplitude of the metformin for controlling the glycosylated hemoglobin can only reach 1.5 percent. The overall control standard-reaching rate of T2DM is only 30-40% by using oral hypoglycemic drugs and injected insulin in western medicine clinic.

Therefore, in nearly a century, oral hypoglycemic agents and insulin have not really cured T2 DM.

The prior art also exists for treating type two diabetes using methods that are homologous in both medicine and food, such as:

in patent document CN108112996A, the decomposition and absorption of starch ingested by three meals in the gastrointestinal tract are reduced by using white kidney bean extract as a non- α amylase blocking agent, but the method has the following problems that 1, the starch blocking agent must be taken while a staple food or snack is ingested every time, 2, the starch blocking agent has no help on the restoration of islet β cells and the function recovery of insulin secretion, and 3, the postprandial blood sugar level is only one of diabetes indexes and can only be used as a control index and cannot represent the diabetes recovery index.

The research subject of south China sea ocean research institute is that the sea cucumber peptide is used for feeding mice, and the result shows that the sea cucumber peptide has a morphological effect of restoring islets of Langerhans β cells of the mice, which is direct evidence of restoring and repairing cells of the sea cucumber peptide on type II diabetes and is a successful technology for the application of the sea cucumber peptide on the type II diabetes.

Disclosure of Invention

In order to effectively control the blood sugar of a diabetic patient and reduce the incidence rate of diabetic complications, the invention carries out pioneering exploration on the pathogenesis of diabetes, and discloses a formula food with special medical application from the perspective of food therapy based on the theory of homology of medicine and food.

First, in the pathogenesis and mechanism of diabetes, the invention discovers that the etiology of type II diabetes is related to the intake of specific substances by human bodies. The specific substances include: 1. a food additive; 2. antibiotic residues in the meat of the livestock and poultry are cultured industrially; 3. pesticide residues in the out-of-season fruits and vegetables in the greenhouse; 4. western medicines; 5 environmental pollution, in particular heavy metals, detergents, chemical compounds in soils, water sources and air. The specific substances are hidden in food and environment and are unconsciously taken into the body by all nationalities from the middle and late stages of the last 80 years. The long-term intake of the above specific substances causes oxidative stress of cells, inflammation, an increase in the proportion of fat, a defect in insulin action (insulin resistance), and impaired liver function, thereby leading to a metabolic chronic disease characterized by an increase in blood sugar.

Specifically, food additives are exemplified. Before 1980, only more than 200 food additives produced by taking natural animals and plants as main raw materials, such as grain fermented coloring agents of red yeast rice and the like, and sweetening agents taking cane sugar as main raw materials are available worldwide. By the date of this application, there have been about 2.5 tens of thousands of chemical synthetic flavors, colorants, preservatives, anti-freezing agents, moisture-proofing agents, mold-releasing agents, antifoaming agents, wetting agents, fragrances, artificial sweeteners, and the like. 1000 new products are taken as raw materials every year, and can be found in 10 thousands of different foods and medicines. According to import and export customs statistical data and data in fine chemical journal articles, the diffusion quantity usage amount of the food additive for over 30 years is the same as the development trend of diabetes.

In order to verify the positive correlation between the food additive and diabetes, the inventor of the present invention conducted a survey based on different income groups of Houston in the United states and concluded that the incidence of obese diabetes is directly proportional to the amount of non-food ingredients in the ingested food. Specifically, low-income groups ingest food additives up to 75 pounds per year; average annual food additive intake in houston was 25 pounds; high income populations consume 1-3 pounds of food additives per year. The ratio of the intake of the food additive for different people is consistent with the incidence of obesity-diabetes in the people. The incidence rate of obesity and diabetes mellitus of low-income people is more than 75 percent; the high income crowd is within 3 percent.

Secondly, industrialized breeding and planting are popularized worldwide in the late 80 s, from 1% to 70% of the present. At present, fruits, vegetables and meat are all produced by an industrial method, and the food produced in a full natural state is less than 30 percent. The industrial production causes the application of fertilizers, hormones and antibiotics to become a common phenomenon. The fertilizer, the technology and the antibiotics not only enter the human body, but also are diffused in soil, surface vegetation and even air. For example, the herbicide glyphosate and the sweetener aspartame are taken as examples, the two substances are artificially synthesized in 60 years, and are applied for marketing approval in 70 years and are marketed in the middle and later period of 80 years. The annual output of the two substances has increased to 3 ten thousand tons per year since the approval of the marketing, the output value reaches hundreds of billions of yuan, and the diffusion trend of the two substances is consistent with the development of diabetes.

Namely, the incidence rate of the type II diabetes shows obvious positive correlation with the use of food additives and antibiotics, the use of pesticide residues, the use of western medicines and the residues of heavy metals and chemical compositions in the environment, particularly in soil, water sources and air.

The application also finds that 1, the specific substances are acidic and fat-soluble, are very difficult to emulsify and are soluble in water; can not be completely digested, decomposed and eliminated in the body, and slowly accumulates in blood, visceral fat, subcutaneous adipose tissue and fascia tissue (the support and storage system of the human body); 2. the specific substances can generate toxic action on the inner wall (epithelial cells) of blood vessels, functional cells of internal organs and the like; 3. in order to eliminate or reduce the toxicity of the specific substances, the human body can weaken the efficacy of a mitochondrial respiratory chain, reduce the consumption of glucose and increase the synthesis of fatty acid under the condition of inflammation; 4. the fatty acids can further form long-chain fat, and the specific substances are wrapped, so that the toxicity to functional cells is reduced; 5. without blocking these specific substances (including oral hypoglycemic agents), insulin resistance could not be completely improved, islet cells could not be truly repaired, and T2DM could not be truly reversed.

Further, the inventor of the present invention has found that the use of the above food additives, antibiotics, pesticide residues, western medicines, and residues of heavy metals and chemical compounds in the environment, especially in soil, water source and air, are related to the oxidative stress of the body.

Similarly, more than 90% of the food ingested by humans and 95% of the oxygen breathed are converted or consumed by the mitochondrial tricarboxylic acid cycle and respiratory chain, and the specific substances in food are also present in mitochondria, which bring more free radicals to mitochondria, which in turn destroy the mitochondrial membrane receptor population including β -adrenergic receptor, TGF- β receptor, dopamine receptor, acetylcholine receptor, etc., and the redox reaction enzyme population of the mitochondrial respiratory chain including NADH dehydrogenase/oxidase, succinate dehydrogenase/oxidase, ATP synthase, etc., and cause the affinity of the substrate to decrease, the reaction Km value to increase, further increase the production of free radicals, thus continuing the vicious cycle, insufficient cellular energy, slowing of repair, and impaired function.

The life span of mitochondria is about 10 days, and the deceased or damaged mitochondria can be supplemented by intact direct mitochondrial division, which is shown by compensatory increase of mitochondria in islet β cells during inflammation of the pancreas, leading to increased insulin secretion (which is why insulin is increased more at the early stage of diabetes than at normal), increased mitochondria are common in chronic injury, and irreversible decrease of mitochondria is seen when the injury continues to increase, which is shown by severe damage of islet β cells and irreversible decrease of insulin secretion at the later stage of diabetes.

The specific substances enter human body, and cause damages to the metabolic system, endocrine system, immune system and fascia (of human body) supporting and storing system of human body, and chronic metabolic and immune diseases appear after the damages reach certain irreversible degree over time.

Based on the reasons and pathogenesis of the type II diabetes, the application creatively discovers that the combination of the sea cucumber peptide, the medicinal and edible nutrient components and the mitochondrial nutrient can effectively promote the regeneration of mitochondria and promote the repair of insulin. Specifically, the invention discloses a sea cucumber peptide-containing medicinal and edible special medical application formula food for rehabilitation of type II diabetes. The formula food for special medical application comprises the following components:

a) a mitochondrial nutrient;

b) sea cucumber peptides;

c) medicinal and edible nutritional components;

d) a natural sweetener;

the medicinal and edible nutritional component comprises: white kidney bean protein, plantain seed shell powder, inulin, mulberry leaf, konjac glucomannan, green coffee and quinoa powder.

Wherein the component a) mitochondrial nutrient is nutrient which has the function of protecting the integrity of mitochondrial structure or promoting the exertion of mitochondrial function and at least comprises the combination of coenzyme Q10 and lipoic acid. In a preferred embodiment, the mitochondrial nutrient comprises coenzyme Q10, lipoic acid, acetylcysteine, acetyl carnitine, creatine, vitamin B group, other vitamin groups, chromium nicotinate, magnesium glycinate, zinc sulfate, hydroxytyrosol.

The other vitamin group comprises: vitamin C; a vitamin E; a vitamin A; vitamin D3. The total weight of the food based on the formula for special medical application is 100 parts by weight, wherein the component a) is 1-10 parts by weight of mitochondrial nutrients, the sea cucumber peptide is 5-20 parts by weight, the medicinal and edible components are 66-90 parts by weight, and the natural sweetener is 1-10 parts by weight.

In a preferred embodiment of the present invention, the mitochondrial nutrient and the sea cucumber peptide are added in a ratio of, based on 100 parts by weight of the sum of the total weight of the mitochondrial nutrient and the sea cucumber peptide: 1: 99-30: 70; in a more preferred embodiment, the ratio of mitochondrial nutrients to sea cucumber peptides is 1: 99-10: 90, respectively; in a more preferred embodiment, the ratio of mitochondrial nutrients to sea cucumber peptides is: 3: 97-5: 95; in a most preferred embodiment, the ratio of mitochondrial nutrients to sea cucumber peptides is 5: 95.

In a preferred embodiment of the invention, the mitochondrial nutrient and the sea cucumber peptide are mixed in a weight ratio of 5:95, uniformly mixing to prepare the mixed nutrient of the mitochondrial nutrient and the sea cucumber peptide. And further mixing the mixed nutrient with medicinal and edible components. The addition ratio of the mixed nutrient to the medicinal and edible component is preferably 10:90-50:50, and more preferably 20:80-30: 70.

Based on the total weight of the formula food for special medical use being 100 parts by weight, the addition amount of the medicinal and edible components is as follows: 4-10 parts of white kidney bean protein, 20-30 parts of plantain seed shell powder, 5-10 parts of inulin, 2-5 parts of mulberry leaves, 15-30 parts of konjac glucomannan, 2-5 parts of green coffee and 10-25 parts of quinoa wheat powder.

In a preferred embodiment, the component c) is a refined raw material obtained by crushing the medicinal and edible nutritional component according to the addition amount of the medicinal and edible nutritional component, extracting, and further filtering and drying the extract.

In a preferred embodiment, the natural sweetener is arabinose.

In the food formulation for special medical use according to the invention, coenzyme Q10 is present in an amount of 5 to 8%, lipoic acid is present in an amount of 15 to 20%, acetylcysteine is present in an amount of 2 to 4%, acetyl carnitine is present in an amount of 2 to 4%, creatine is present in an amount of 25 to 30%, vitamin B group is present in an amount of 1.3 to 1.6%, other vitamin groups are present in an amount of 3 to 4%, chromium nicotinate is present in an amount of 0.03 to 0.04%, magnesium glycinate is present in an amount of 8 to 10%, zinc sulfate is present in an amount of 25 to 30%, and hydroxytyrosol is present in an amount of 2 to 3%, based on the.

In the formula food for special medical use of the invention, based on the total weight of the vitamin B group, the vitamin B group contains 20-22% of B1, 3-4% of B2, 41-43% of B3, 20-22% of B5, 10-11% of B6, 0.5-0.7% of B7, 0.1-0.2% of B12 and 0.7-0.9% of folic acid.

The other vitamins comprise 85-86% of vitamin C and 11-13% of vitamin E; vitamin A accounts for 1.5-1.7%; vitamin D3 accounts for 0.03-0.04%.

The sea cucumber PEPTIDE is a part of active ingredients of holothurin, the international raw material registration is INCI: HO L OTHURIN-PEPTIDE, and international chemical inquiry CAS # 868844-74-0.

The sea cucumber peptides described herein can be obtained by techniques known to those skilled in the art prior to the filing date of the present application.

In a preferred embodiment, the sea cucumber peptide is extracted from internal organs of live sea cucumber and is a polypeptide complex consisting of 40-60 amino acids and 190-200 amino acids.

The biological action mechanism of the sea cucumber peptide is that the sorbitol bypass metabolism is improved or eliminated through the repair action on cell membranes of liver cells, pancreatic cells and muscles, and an insulin receptor on the surface of the cell membrane recovers the recognition capability on insulin, so that the abnormal glucose tolerance phenomenon is improved, the cells obtain blood sugar and increase basal metabolism, and the goal of stabilizing blood sugar is reached.

The invention discloses a sea cucumber peptide formula food with special medical application, which is a composite food composition. The food composition is not simply a nutritional function overlay and blend. In addition, the food composition has the functions of burning fat and eliminating toxins wrapped by the fat in vivo, including the functions of eliminating free radicals in cells, reducing blood sugar and food additive residues. The sea cucumber peptide special medical application formula food also has the effects of restoring blood sugar control, balancing and stabilizing blood sugar, and eliminating the side effect of hypoglycemic drugs and diabetic complications.

Compared with the pure use of the sea cucumber peptide, the food composition with the special medical application formula disclosed by the invention has quick response to the repair of cell membranes, the improvement of insulin resistance can be detected within 3-7 days, and the fasting blood sugar and the 2-hour postprandial blood sugar level are correspondingly reduced. But the recovery time of the islet cells is 15-25 days, so that the health care is obviously improved. The whole diet therapy time is 45-90 days, and the effect can be confirmed by a third party physical examination, specifically according to indexes such as fasting blood sugar, postprandial blood sugar or glycosylated hemoglobin, the constitution of a patient and the like. In a preferred embodiment, the sea cucumber peptide special medical use formula food further comprises sea cucumber saponin, sea cucumber phospholipid, odd-numbered fatty acid and branched-chain fatty acid. The sea cucumber saponin is derived from saponins in animal kingdom and is one of the root causes of 'yin and yang tonifying' of sea cucumber; the sea cucumber phospholipid 90% is functional lipid and almost contains no cholesterol (less than 1%). Further, odd-numbered fatty acids and branched fatty acids are preferably contained.

The biomedical effects of the holothurin (holothurin) and the holothurin peptide and holothurin phospholipid comprise: improving immunity, and has cytotoxic effect on tumor cells; has broad-spectrum inhibition of pathogenic bacteria, mould and antiprotozoal activity; resisting tissue cell oxidation, resisting stress reaction, and stimulating bone marrow erythrocyte growth; has female hormone-like activity; resisting fatigue, supplementing fascia fat component, and increasing stem cell reserve and differentiation capacity of fascia system.

The medicinal and edible nutritional components comprise white kidney bean protein, plantain seed shell powder, inulin, L-arabinose, mulberry leaves, konjac glucomannan, green coffee and quinoa powder.

The white kidney bean protein is a natural α amylase inhibitor, which can inhibit the activity of starch before converting the starch into glucose in human body, thus effectively controlling the speed and ratio of starch to sugar, and having the physiological effect of regulating blood sugar, strengthening spleen and kidney, and promoting the mitosis of leukemia and hemagglutination.

The inulin is dietary fiber, effectively promotes gastrointestinal tract peristalsis, reduces the retention time of food in the gastrointestinal tract, relatively reduces digestion and absorption of starch, slows down blood sugar fluctuation of sugar friends and increases defecation efficiency under the condition of not imaging physiological functions of the gastrointestinal tract.

L-arabinose is levorotatory monosaccharide which is separated and extracted from colloid secreted by Arabic tree, L-arabinose utilizes the affinity of arabinose and sucrase to be larger than that of cane sugar and sucrase, so that the increase of blood sugar caused by the intake of cane sugar (decomposed into glucose and fructose under the action of sucrase in small intestine is inhibited), the mechanism is called sugar reduction for inhibiting the hydrolysis of disaccharide, L-arabinose inhibits the hydrolysis of disaccharide, so that cane sugar which is not decomposed in small intestine is decomposed by microorganisms in large intestine to generate a large amount of organic acid, and the organic acid has an inhibition effect on the synthesis of fat by liver, and L-arabinose inhibits the absorption of cane sugar in small intestine, thereby reducing the generation of new fat in vivo.

The mulberry leaves are medicinal and edible plants, contain 1-Deoxynojirimycin (DNJ) alkaloid which is an alkaloid only existing in the mulberry leaves, is a natural α -glycosidase inhibitor, also has the activity of inhibiting sucrase, maltase and alpha-amylase, can stimulate insulin secretion and reduce the decomposition speed of insulin, and the mulberry leaves collected after frost contain DNJ, rich gamma aminobutyric acid and phytolac, the content of the gamma aminobutyric acid and phytolac is 3-4 times of that of green tea, and the mulberry leaves have obvious effects of improving blood viscosity, reducing blood fat (especially lipofuscin), resisting atherosclerosis, resisting aging and improving the activity of superoxide dismutase.

The main active ingredient of the green coffee is chlorogenic acid (chlorogenic acid), which can irreversibly inhibit the hydrolytic activity of glucose-6-phosphatase, reduce the decomposition of hepatic glycogen and the absorption of exogenous glucose, and promote human body to decompose fat in vivo to supplement energy.

The quinoa (Chenopodium quinoa willd) is called as the "mother of food" because of its unique abundant and comprehensive nutritive value. The food agriculture organization of the united nations considers the quinoa to be the only single plant which can basically meet the basic nutritional requirements of the human body, and the quinoa is formally recommended to be the perfect full-nutritional food which is most suitable for the human.

Chenopodium quinoa belongs to Chenopodium plants in family of Chenopodiaceae, belongs to low glycemic food, does not produce the phenomenon of 'starch addiction', is tolerant to barren, drought, salt and alkali, cold and very strong in seed vitality, is full-grain full-nutrition complete protein alkaline food, embryo accounts for 32% of seeds, endosperm accounts for 68%, has no ectoderm and gluten, does not produce gluten allergy to human bodies, has nutritional activity and biological activity, has protein content and quality equivalent to meat, has proper amino acid proportion and is easy to absorb, is particularly rich in lysine, calcium, magnesium, phosphorus, potassium, iron, zinc, selenium, manganese, copper and other mineral substances which are deficient in plants, has high nutritional content, is rich in unsaturated fatty acid, flavonoid, B vitamins and vitamin E, choline, betaine, folic acid, α -linolenic acid, β -glucan, L unasin and other beneficial compounds, has high dietary cellulose content of up to 13.4%, has zero cholesterol, low fat, low calorie (305kcal/100g), has low glycemic value (5000-g value), is reduced in metabolic activity of embryo and has a plurality of wheat germ degrading peptide (EBASD 54) and improving metabolic activity of fat degrading gene (36800) and improving metabolism.

The mitochondrial nutrient provided by the invention is a nutrient which can protect the structural integrity of mitochondria or promote the exertion of mitochondrial function, and comprises the combination of lipoic acid and coenzyme Q10.

α -lipoic Acid, called super antioxidant, is the antioxidant with the highest function and activity among all antioxidants, and also induces vascular smooth muscle cells to produce PGC-1 α (peroxidase proliferation activation receptor gamma-cofactor 1 α), stimulates mitochondrial regeneration, regulates ATP yield, and regulates nuclear DNA telomerase PGC-1 α helps patients reduce dependence on insulin and hypoglycemic drugs, balances blood glucose, promotes glucose absorption, improves glycemic control of diabetic patients, reduces insulin or hypoglycemic drugs, protects diabetic nervous tissues, helps treat neuropathy, and helps treat inflammation caused by protein deposition in nerve cells.

As for the mechanism, PGC1 α has multiple hormone receptors on the cytoplasmic nuclear membrane, including PPARs (peroxisome proliferator hormone receptors), NRF-1/2 (nuclear respiratory factor 1-2), GR (glucocorticoid receptor), ER (estrogen receptor), HNF4 α (hepatocyte nuclear factor receptor), RXR (retinoic acid X receptor), TR (thyroid hormone receptor) and MEF2 (myocyte specific enhancer), and the like, which are signals and mediators of mitochondrial activity and the coordination between mitochondria and the nucleus.

Coenzyme Q10 is a cofactor for mitochondrial complex I/II/III, a mitochondrial antioxidant; meanwhile, the composition can provide power for the heart, and also has excellent functions of myocardial oxidation resistance, fatigue resistance, free radical removal, vessel wall lipid peroxidation prevention, atherosclerosis prevention and the like.

In a preferred embodiment of the present application, the above mitochondrial nutrient comprises coenzyme Q10 or a physiologically acceptable salt thereof. The mitochondrial nutrient further comprises lipoic acid or a physiologically acceptable salt thereof.

In a more preferred embodiment, the mitochondrial nutrient comprises: coenzyme Q10, lipoic acid, acetylcysteine, acetyl carnitine, creatine, vitamin B group, other vitamin groups, chromium nicotinate, magnesium glycinate, zinc sulfate and hydroxytyrosol.

Wherein acetylcysteine is a precursor of mitochondrial antioxidant, glutathione GSH; improve the respiratory function and increase the gas exchange area. Enhancing the immune function of the body: lipoic acid can inhibit the replication of viruses, stimulate the replication response of T-lymphocytes, increase the number and activity of T-lymphocyte subgroups, increase the adhesion and phagocytosis of macrophages, protect cells from relevant damage caused by viral infection, and has three antioxidation effects: directly acts on free radicals (no enzyme participates in reaction); the provided H + can restore the reduction state of GSH, and has the functions of indirect antioxidation and free radical removal; supports the biosynthesis of hepatocyte GSH, thereby exerting an antioxidation effect.

The acetyl carnitine (acetyl L-carnitine) is a substance naturally existing in a human body, and is abundant in muscles and brains; participate in a series of metabolic processes, take acetyl from cells, and simultaneously transfer long-chain fatty acid to pass through a mitochondrial membrane and assist energy transfer; also increases cardiolipin levels, enhances respiration, and has secondary antioxidant function; it also helps male reproduction and sperm motility.

The Creatine is a substance synthesized by three amino acids of arginine (arginine), glycine (glycine) and methionine (methionine), is an amino acid derivative naturally generated in a human body, and can quickly increase muscle strength, accelerate fatigue recovery and improve explosive force. The more creatine is stored in the human body, the stronger the strength and the exercise ability are. It not only can provide energy quickly but also can increase strength, increase muscle and accelerate fatigue recovery. The more creatine is stored in human body, the more sufficient energy is supplied, the faster the fatigue is recovered, and the stronger the exercise energy is. But the creatine requirement cannot be completely met in daily diet.

Among them, the B vitamins are essential for maintaining mitochondrial activity, and under normal conditions, the B vitamins are obtained in sufficient amounts and types from fresh vegetables and fruits, and it is almost impossible to meet the demand only from vegetables and fruits.

B1 (thiamine) among the above vitamins is a substance required for a key reaction catalyzed by α -keto acid dehydrogenase, pyruvate dehydrogenase, α -ketoglutarate dehydrogenase in mitochondria;

b2 (riboflavin) is a precursor of flavin adenine mononucleotide and flavin adenine dinucleotide, both of which participate in various redox reactions and are essential for mitochondrial energy production.

B3 (nicotinic acid) is a precursor of nicotine adenine dinucleotide and nicotine adenine dinucleotide salt, a substrate and cofactor of mitochondrial respiratory chain complex I, and is involved in reactions of multiple tricarboxylic acid cycles, DNA synthesis, and fat metabolism.

B5 (hydroxy acyl pantothenate) is involved in fat and protein metabolism and is an essential component for the synthesis of fat and cholesterol in the tricarboxylic acid cycle.

B6 (pyridoxine) is a coenzyme of two essential enzymes of protein metabolism, and can relieve insulin-induced diabetic vascular disease complications, especially arteriosclerosis; can also maintain the normal functions of blood, muscle, nerve and skin of human body, synthesize antibody and gastric acid; need to maintain Na/K balance, appetite, etc.

B7 (biotin), also known as vitamin H and coenzyme R, is an essential substance for the synthesis of vitamin C, and is an indispensable substance for the normal metabolism of fat and protein. Is a nutrient necessary for maintaining the natural growth, development and normal function of human body, and is also a coenzyme of various carboxylases, and plays a role of a CO2 carrier in carboxylase reaction.

B12 (Cobalamin) is involved in the generation of erythrocytes and epithelial tissues, is a coenzyme of methylmalonyl coenzyme A mutase in mitochondria, and B12 coenzyme is also involved in methyl and other one-carbon unit transfer reactions, so that a human body is not easy to lack B12 under normal conditions, but B12 shows complementary significance under the conditions of anemia, liver function damage, hyperglycemia poison, fat and protein metabolism disorder, folic acid deficiency and the like.

Folic acid (B9) is a hematopoietic vitamin, is necessary for DNA synthesis, particularly mitochondrial DNA synthesis (participates in purine and thymine synthesis and has influence on mitochondrial regeneration and cell division), is a coenzyme of a one-carbon unit transferase system, is not easy to lack under normal conditions, but is insufficient under the conditions of a great amount of out-of-season vegetables and fruits and greenhouse cultivation at present.

Other groups of the above vitamins include: vitamin C, vitamin E, vitamin A and vitamin D3. Wherein vitamin C is a first-line antioxidant of cytoplasm and mitochondria, participates in a plurality of reduction and hydroxylation reactions, and promotes the synthesis and maintenance of ossein, neurotransmitter, immune antibody, fascial mother cell and the like; and the synergistic effect of tocopherol, nicotinic acid and the like on eliminating free radicals and dead cell fragments, and the essential substances for protecting the liver, the fascia system and the immune system are maintained.

Wherein vitamin E (α -tocopherol) is the most important fat-soluble antioxidant, is gathered in flowing lipoprotein, cell membrane and adipose tissue, is abundantly present on the inner membrane of mitochondria, plays an important role in protecting mitochondria, has a synergistic effect with vitamin C, vitamin A, selenium and bioflavonoid antioxidant substances, and plays a very key role in mitosis, oxygen utilization, aging and immunity of mitochondria and cells.

Wherein vitamin A (retinol/carotenoid) is lipid soluble antioxidant, and can protect nuclear mitochondrial DNA and cytochrome b in cell membrane from light damage; maintenance of vitamin E, C levels, maintenance of vision, levels of cellular, immunoglobulin and bone growth essential substances.

Wherein vitamin D3 (cholecalciferol) vitamin D is a fat-soluble vitamin which is a hormone precursor for calcium and phosphorus metabolism, and vitamin D3 has effects of improving absorption of calcium and phosphorus by organism, promoting growth and skeleton calcification, and promoting teeth health; preventing amino acid loss through kidney, and preventing autoimmune diseases, hypertension, osteoporosis and diabetic complications.

Chromium nicotinate in the above mitochondrial nutrient formulation provides a trace element necessary for the human body, and has three functions in the human body, namely, first, it coordinates the action of insulin to promote normal operation of carbohydrate and fat metabolism in the body, second, it is a stabilizer for ribonucleic acid and deoxyribonucleic acid, and third, it is an activator for certain enzymes, and chromium deficiency of the human body is characterized by impaired glucose and lipid metabolism, and the chromium content in diabetic patients is lower than that in healthy people, and is found to be associated with the course of the disease.

Magnesium glycinate in the mitochondrial nutrient formula provides divalent magnesium which is a main cation in human cells and is accumulated in mitochondria, and is second to potassium and phosphorus; next to sodium and calcium, in extracellular fluid, magnesium is an essential substance for basic biochemical reactions of various cells in vivo, and magnesium is used as an activator of various enzymes to participate in more than 300 enzymatic reactions; in metabolism of calcium, vitamin c, phosphorus, sodium, potassium and the like, magnesium is an essential element and plays an important role in neuromuscular operation and blood sugar conversion. Magnesium glycinate as magnesium supplement is more suitable for human body absorption and allergy reduction than magnesium gluconate, and is more effective in treating anorexia, nausea, emesis, fatigue and weakness, numbness, tingling, muscle spasm, personality change, abnormal heart rate, etc. induced by hypoglycemic agent.

The zinc sulfate in the mitochondrial nutrient composition is more suitable for supplementing zinc element than zinc gluconate, the zinc is an essential component of more than 80 enzymes in a human body, the zinc-metallopeptidase is an insulin degrading enzyme and is used for regulating the content of β -amyloid protein and plasma membrane insulin of mitochondria in cells, the zinc-related enzyme inhibits apoptosis caused by ATP failure, and the zinc deficiency can induce accumulation of mitochondrial peroxide, so that osteoporosis, bone hypoplasia, nerve spasm, growth and development, anorexia and the like are caused.

The hydroxytyrosol in the prescription of the mitochondrial nutrient is a natural antioxidant contained in olive oil, has the pharmacological effects of resisting stress reaction induced by hyperglycemia, promoting mitochondrial regeneration, resisting cancer, resisting thrombus, regulating blood fat, resisting arteriosclerosis, resisting pathogenic microorganisms, preventing and treating macular degeneration of retina, protecting cartilage, resisting osteoporosis and the like.

The invention also discloses a preparation method of the nutritional combined formula food for type II diabetes, which comprises the following steps:

checking that the water content of all the materials does not exceed the standard, the fineness reaches 80-100 meshes, and no abnormal taste and impurities exist;

(1) weighing the component b) sea cucumber peptide for later use;

(2) weighing the component c) medicinal and edible nutritional components, and mixing the components in the component c);

(3) mixing the sea cucumber peptide component obtained in the step (1) with the medicinal and edible component obtained in the step (2);

(4) weighing a component a) mitochondrial nutrient, and further mixing the component a) with the mixture obtained in the step (3);

(5) drying the product obtained in the step (4);

(6) packaging the product of the step (5);

wherein the mesh number of the sieved components in the steps (1) to (3) is 80 to 100 meshes.

The component b) is prepared by homogenizing fresh sea cucumber, carrying out enzymolysis to obtain sea cucumber polypeptide liquid, and further carrying out freeze drying on the polypeptide liquid to obtain sea cucumber polypeptide powder.

In a further embodiment of the invention, component b) may also be a sea cucumber peptide, which is commercially available.

The sea cucumber peptide

And (5) further performing irradiation sterilization after drying to obtain a product.

Wherein, after the component c) is weighed in the step (2), the effective components of the component c) are extracted by extraction, and the extract is further filtered and dried to obtain the refined component.

Wherein the mixing time in the step (2) and the step (3) and the step (4) is 20-30 minutes, and the relative humidity of the mixing environment is 50%.

Wherein the drying temperature in the step (5): 60-70 ℃.

In a preferred embodiment, the sea cucumber polypeptide is prepared by homogenizing and carrying out enzymolysis on fresh sea cucumbers to obtain sea cucumber polypeptide liquid, and further freeze-drying the polypeptide liquid to obtain sea cucumber polypeptide powder.

In a preferred embodiment, the product obtained by drying in step (4) is further subjected to radiation sterilization.

In a preferred embodiment, wherein the component c) is weighed in step (2), the active ingredient of the component c) is extracted by extraction, and the extract is further filtered and dried to obtain a refined component.

The mixing time in the step (2) and the step (3) and the step (4) is 20 minutes to 30 minutes, and the relative humidity of the mixing environment is 50 percent.

In a preferred embodiment, wherein the drying temperature in step (4): 60-70 ℃.

The components are not simply added and mixed in nutrition function and are mutually synergistic in the nutrition formula. The invention can promote the regeneration of mitochondria, promote the repair of islet cells and restore the immune function and the cell metabolism function. In addition, the present invention has the effect of burning fat, and can eliminate toxins, including intracellular free radicals, encapsulated by fat in the body. The invention also has the effects of restoring blood sugar control, balancing and stabilizing blood sugar, and eliminating the side effect of hypoglycemic drugs and diabetic complications.

The components of the invention are mutually matched to be used as the components of the nutrient, thereby ensuring the safety and the effect, having simple method, quick response and quantifiable effect, being repeated and verified by a third party, and having stricter and more comprehensive verification method compared with the clinical examination, the standard for standard of national diabetes treatment (CDS) and the American ADA and WHO standards. See in particular table 6 of the present application.

The invention provides nutrient elements through a nutrition therapy, and all the components of the invention are natural components, have no side effect on human cells, do not generate oxidative stress reaction and immune reaction, dissolve the long-term accumulated toxins of human bodies deeply buried in fat tissues and fascial tissues, discharge cells and tissues, normalize human organs and systems, recover functions, improve various discomforts induced by hypoglycemic drugs and blood sugar toxins, gradually repair cells, improve cell metabolism, stabilize blood sugar balance and finally recover the function of insulin secretion of pancreatic islet β -cells.

Compared with CN108112996A, the assessment indexes are only fasting blood glucose FBG, postprandial blood glucose 2 hPGG and glycosylated hemoglobin HbA1c, and the blood pressure and blood fat items required by Chinese diabetes treatment standard (CDS) are not provided, and the indexes such as body weight BMI, insulin, visceral fat, body fat rate, heart and lung function, complications and the like are not provided. The only indication of blood glucose in this document does not mean that the diabetic is otherwise healthy or well-felt.

The composition of the invention is practiced in nearly 30 years, and has nearly 35 million customers from the American Beller college of medicine to Shenzhen, Guangzhou, Ximen, Fuzhou, Nanjing, Xian and the like which are respectively completed by different enterprises, and has no invalid case, no case of complication caused by aggravation and no case of customer complaint.

The nutritional therapy combines the original ecological food materials and aerobic exercises, so that the economic cost of prevention and treatment is low, the time cost is lower, the effect is quick, the normal life and work of a patient are not influenced, families and enterprises are not provided, and the national burden is not brought. The preparation has the advantages of no need of injection, no need of medicine, no wound, no abdominal distension, no anorexia, endocrine balance, rapid fat reduction, weight loss, elimination of toxin accumulated in the body and wrapped by adipose tissue, blood sugar reduction, and visceral fat reduction. Compared with the situation that most weight loss can reduce the basal metabolic rate, the weight-reducing health-care food maintains the basal metabolic rate, improves the immunity, improves the endurance and the reproductive capacity, and eliminates the side effect caused by the blood-sugar-reducing and blood-fat-reducing medicines.

The invention combines the original ecological food recipe to completely block new toxins, such as food additives, pesticide residues, drug residues and environmental pollution, further thoroughly discharges the toxins accumulated in the human body out of the human body in a fat elimination mode, takes cells and mitochondria as targets, quickly improves the cell activity, recovers the cell functions, including the islet cell function, combines a proper amount of aerobic exercise, improves the blood oxygen concentration and the cardiopulmonary function, eliminates the oxidative stress reaction of the cells and tissues, and can achieve the purpose of reversing the primary (early stage of clinic) type II diabetes or the insulin resistance.

Detailed Description

Experimental raw materials and sources:

the mitochondrion nutrition reagent for experiments is provided by Anhui Feng original, the nutrition components are provided by 100 parts by weight based on mitochondrion nutrients, wherein 6 parts of coenzyme Q10, 20 parts of lipoic acid, 2 parts of acetylcysteine, 2 parts of acetylcarnitine, 25 parts of creatine, 1.5 parts of vitamin B group, 3.46 parts of other vitamin group, 0.04 part of chromium nicotinate, 8 parts of magnesium glycinate, 30 parts of zinc sulfate and 2 parts of hydroxytyrosol, the nutrition components are 100 parts by weight based on the total weight of the vitamin B group, wherein 20 parts of B1 thiamine, 3 parts of B2 riboflavin, 41 parts of B3 niacin, 20 parts of B5 pantothenic acid, 10 parts of B6 pyridoxine, 0.5 part of B7 biotin, 0.1 part of B12 cobalamin, 0.7 part of folic acid, 100 parts by weight based on the total weight of other vitamin group, the vitamin C accounts for 85 parts, 11 parts of vitamin E (α -tocopherol), 11 parts of vitamin A (retinol), 0.5 parts of vitamin A (vitamin A) and 0.5 parts of calcium D (3.03) are uniformly mixed according to the mitochondrion nutrition components and calcium content of the mitochondrion nutrients.

Sea cucumber peptides are provided by Baiyunshanbei Bydi biomedicine, Guangzhou.

Experimental animal models were provided by the Guangdong province medical laboratory animal center using transgenic J000642BKS. Cg-m +/+ L eprdb/J (type II diabetes model) mice.

The mice were derived from JAX, are homozygous mice spontaneously mutated for obesity (L epob). in addition to obesity and hyperglycemia (> ═ 10 mmol/L), the mutant mice also exhibited hyperphagia, diabetic-like hyperglycemia syndrome, impaired glucose tolerance, elevated plasma insulin, reduced fecundity, impaired wound healing, and elevated pituitary and adrenal hormone levels.they also exhibited hypometabolism and reduced body temperature.their obesity was characterized by increased numbers and volumes of adipocytes.in the C57B L KS background, ob homozygote (Stock No.000696) exhibited severe symptoms of diabetes, islet degeneration and early death.this animal model was more stable than the hyperglycemic animal model induced by alloxan or streptozotocin and conformed to the natural conditions of the non-drug intervention test for diabetes.

Mouse experimental groups 1-5, mouse experimental control groups 1-3:

80J 000642 mice with average body weight of 30-35 g and half of male and female are taken, 10 mice are divided into 8 groups randomly. 2g of mitochondrial nutrients and mixed nutrients of sea cucumber peptides were mixed into 8g of feed daily and fed freely. The observation was continued for 14 days. 2 grams of nutrients by weight correspond to 10 times the dosage for a human.

Grouping according to different proportions of mitochondrial nutrition and sea cucumber peptide nutrition, wherein the control group 1 is a blank control group; the dose ratio of the mitochondrial nutrition and the sea cucumber peptide nutrition of the control group 2 is 0.0:100, and the ratio of the mitochondrial nutrition and the sea cucumber peptide nutrition of the control group 3 is 100: 0.0; experiment 1 group the ratio was 3.0: 97.0; experiment 2 group is 4.0-96.0; experiment 3 group was 5.0: 95.0; experiment 4 set was 10.0:90.0 of the total weight of the alloy; experiment 5, group 15: 85.

every 2 hours in the daytime, the diet, behavior and defecation of the mice are observed and recorded through a secret observation window, and the presence or absence of abnormal behavior reaction and death conditions are observed. The sleep is automatically recorded and observed by infrared rays in the absence of disturbance every night, and only drinking water is given after 8:30 pm. Fasting glucose was measured by portable glucometer with weight recorded once per day at 8:30 (12 hours fasting) in the morning and (tail vein blood harvest). The feeding trial was ended by fourteen days of feeding, but the data continued to be observed by day 21, with the observation period returning to normal feed.

Observation of body weight (gram)

Table 1: mouse experimental group 1-5, control group 1-3 weight monitoring table

2, behavioral Observation

Table 2: behavior monitoring table for experimental group 1-5 and control group 1-3 of mice

3, fasting blood glucose Change (mmol/L)

Table 3: fasting blood sugar monitoring table for mouse experimental group 1-5 and control group 1-3

6-8 groups of mouse experimental group, 4-6 groups of mouse control group:

mixing the mitochondrial nutrient and the sea cucumber peptide according to the weight ratio of 5:95, and uniformly mixing to prepare a mixed nutrient of the mitochondrial nutrient and the sea cucumber peptide for later use, which is called MT-sea cucumber peptide mixed nutrient for short.

The medicinal and edible component comprises, by weight, 5 parts of white kidney bean protein, 28 parts of plantain seed husk powder, 10 parts of inulin, 3 parts of L-arabinose, 5 parts of mulberry leaf, 25 parts of konjac glucomannan, 2 parts of green coffee and 22 parts of quinoa powder, and is crushed and uniformly mixed for later use.

60J 000642 mice with average body weight of 30-35 g and half of each sex were divided into 6 groups at random. 1.5g of nutrients were mixed into 8.5g of feed daily and fed freely. The observation was continued for 14 days. In the mouse experiment, the nutrient is a mixture of MT-sea cucumber peptide mixed nutrient and medicinal and edible components.

Grouping according to different dose ratios of the MT-sea cucumber peptide mixed nutrient and the medicinal and edible components, wherein a reference group 1 is a blank reference group; the dosage ratio of the MT-sea cucumber peptide mixed nutrient of the control group 2 to the medicinal and edible component is 0.0:100, and the dosage ratio of the MT-sea cucumber peptide mixed nutrient of the control group 3 to the medicinal and edible component is 100: 0.0; experiment 1 group the ratio was 10.0: 90.0; experiment 2 group is 20.0-80.0; experiment 3 group was 30.0: 70.0.

1. Body weight observation (gram)

Table 4: weight monitoring table for experimental group 6-8 and control group 4-6 of mice

2. And (4) observing behaviors:

table 5: behavior monitoring table for experimental group 6-8 and control group 4-6 of mice

3. Fasting blood glucose change (mmol/L)

Table 6: fasting blood sugar monitoring table for experimental group 6-8 and control group 4-6 of mouse

According to the mouse experiment, the mitochondrial nutrient and the sea cucumber peptide nutrient are fed to the J000642 experimental mouse, the continuous observation is carried out for 14 days, the stable observation is carried out for 21 days, the food intake, the eating desire, the drinking water, the defecation, the activity condition and the sleep quality of the experimental animal and the control group have no obvious abnormality; no animal quits the test in advance due to abnormality in the experimental period, and finally the whole condition of the experimental animal is tested, the behavior and fasting blood sugar of the mouse using the nutrient of the invention as the dietary supplement are closer to those of healthy mice without diabetes, the mouse is quieter, and the eating and drinking are normal.

The strengthening and synergistic effects between nutrients can be seen through the above mouse experiments. According to the effect data, the addition ratio of the mitochondrial nutrient to the sea cucumber peptide is as follows based on 100 parts by weight of the sum of the total weight of the mitochondrial nutrient and the sea cucumber peptide: 1: 99-10: 90, respectively; the blood sugar value of the experimental mouse is already obviously reduced. In a more preferred embodiment, the ratio of mitochondrial nutrients to sea cucumber peptides is: 3: 97-5: 95; and in the most preferred embodiment, 5% mitochondrial nutrient plus 95% sea cucumber peptide nutrient, the effect is particularly significant (p < 0.01).

After being mixed with the medicinal and edible components, the mouse experimental group which mixes the mitochondrial nutrient, the sea cucumber polypeptide mixed nutrient and the medicinal and edible components can be seen. When the mixed nutrient and the medicinal and edible homologous component are added in a ratio of 10:90-50:50, the behavior, the body weight and the blood sugar value of a mouse are obviously improved, and the more preferable addition ratio is 20:80-30:70, so that the improvement is most obvious.

According to the experimental results, the J000642 transgenic II type diabetes mouse model has the advantages that the mitochondria nutrition and the sea cucumber peptide nutrition are matched, and the good effects of reducing weight and lowering fasting blood glucose are achieved. In combination with the results of the previous acute toxicity test, the combination of the mitochondrial nutrients and the sea cucumber peptide nutrition as food, nutritional supplements or other formula foods with special medical application has good application value in weight management and diabetes prevention and treatment.

Example 9 preparation of a specific medical use formula according to the invention:

based on the weight parts, 10 parts of sea cucumber peptide, 4 parts of white kidney bean protein, 22 parts of plantain seed husk powder, 8 parts of inulin, 3 parts of L-arabinose, 5 parts of mulberry leaf, 25 parts of konjac glucomannan, 2 parts of green coffee, 20 parts of quinoa powder and 1 part of mitochondrial nutrient are weighed, and the total weight is 100 parts.

Wherein the weight is recorded as 100 parts based on the mitochondrial nutrient, wherein: 6 parts of coenzyme Q10, 20 parts of lipoic acid, 2 parts of acetylcysteine, 2 parts of acetyl carnitine, 25 parts of creatine, 1.5 parts of vitamin B group, 3.46 parts of other vitamin groups, 0.04 part of chromium nicotinate, 8 parts of magnesium glycinate, 30 parts of zinc sulfate and 2 parts of hydroxytyrosol.

Based on the total weight of the vitamin B group of 100 parts by weight, wherein: b1 thiamine 20 parts; b2 riboflavin 3 parts; 41 parts of B3 nicotinic acid; b5 pantothenic acid 20 portions; b6 pyridoxine 10 parts; 0.5 part of B7 biotin; 0.1 part of B12 cobalamin; 0.7 part of folic acid.

Based on 100 parts by weight of the total weight of other vitamin groups, the vitamin D vitamin complex comprises 85 parts of vitamin C, 11 parts of vitamin E (α -tocopherol), 1.5 parts of vitamin A (retinol/carotenoid) and 0.03 part of vitamin D3 (cholecalciferol).

The food component of the components is produced according to the following steps:

1) checking that the water content of all the materials does not exceed the standard, the fineness reaches 80-100 meshes, and no abnormal taste and impurities exist;

2) weighing raw materials in parts by weight, and uniformly mixing;

3) the mitochondrion nutrient components are mixed separately in certain proportion and then mixed with other components to ensure homogeneity and avoid moisture absorption.

4) All operations are carried out under the condition of meeting the cleanness, so that pollution is avoided; high temperature and irradiation are avoided;

5) according to the national standard GB/T29602 of solid beverage, the specification of the finished product is as follows: 20 g/bag x 10 bags/box, 3 boxes/big box.

The recommended daily dose and the administration method are as follows: before three meals (10-15 minutes), 200 ml of warm boiled water is used for taking with water or drinking instead of soup;

storage method and shelf life: sealing in a cool, dry and ventilated place (18-25 deg.C), and has a shelf life of 24 months.

Example 10 preparation of a specific medical use formula according to the invention:

weighing 9.5 parts of sea cucumber peptide, 10 parts of white kidney bean protein, 25 parts of plantain seed husk powder, 5 parts of inulin, 2 parts of mulberry leaf, 15 parts of konjac glucomannan, 2 parts of green coffee, 25 parts of quinoa powder and 0.5 part of mitochondrial nutrient, and supplementing the rest to 100 parts by weight with arabinose.

100 parts by weight of mitochondrial nutrient, wherein: 8 parts of coenzyme Q10, 20 parts of lipoic acid, 4 parts of acetylcysteine, 4 parts of acetyl carnitine, 30 parts of creatine, 1.6 parts of vitamin B group, 4 parts of other vitamin groups, 0.04 part of chromium nicotinate, 10 parts of magnesium glycinate, 30 parts of zinc sulfate and 3 parts of hydroxytyrosol.

Based on the total weight of the vitamin B group of 100 parts by weight, wherein: b1 thiamine 22 parts; b2 riboflavin (4 parts); 43 parts of B3 nicotinic acid; 22 parts of B5 pantothenic acid; b6 pyridoxine 11 parts; 0.7 part of B7 biotin; 0.2 part of B12 cobalamin; 0.9 part of folic acid.

Based on 100 parts by weight of the total weight of other vitamin groups, the vitamin D vitamin complex comprises 86 parts of vitamin C, 13 parts of vitamin E (α -tocopherol), 1.7 parts of vitamin A (retinol/carotenoid) and 0.04 part of vitamin D3 (cholecalciferol).

The components are produced according to the following steps:

2) weighing raw materials in parts by weight, and uniformly mixing;

3) the components of the mitochondrial nutrient are independently mixed according to a proportion and then mixed with other components, so that the uniformity is ensured and the moisture absorption is avoided.

5) according to the national standard GB/T29602 of solid beverage, the specification of the finished product is as follows: 3 grams/vial x 21 vial/cassette.

The recommended daily dose and the administration method are as follows: before three meals (10-15 minutes), the meal is taken with 100 ml of warm boiled water and 150 ml of water;

Table 7: example 9 Effect data

Injecting preparation: the evaluation scores and the result judgment are as per table 6; NT is not tested, no data.

Table 8: example 10 Effect data

Injecting preparation: the evaluation scores and the result judgment are as per table 6; NT is not tested (not detected, no data).

Example 9 and example 10, enumerating 10 cases, 10 were effective, with 5 (50%) of the significant effects; the obvious effect is 5 (50%). The effect is stable, the longest record is 9 months, and the shortest record is 50 days; the total effective rate is 100%.

Table 9: the rehabilitation index of type II diabetes mellitus of the application is as follows:

the above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and simplifications made in the spirit of the present invention are intended to be included in the scope of the present invention.

Claims

1. The sea cucumber peptide formula food with special medical application is characterized by comprising the following components:

a) a mitochondrial nutrient;

b) sea cucumber peptides;

c) medicinal and edible nutritional components;

d) a natural sweetener;

2. The sea cucumber peptide special medical use formula according to claim 1, wherein the component a) mitochondrial nutrients comprise coenzyme Q10, lipoic acid, acetylcysteine, acetylcarnitine, creatine, vitamin B group, other vitamin groups, chromium nicotinate, magnesium glycinate, zinc sulfate, hydroxytyrosol.

3. The sea cucumber peptide special medical use formula according to claim 2, wherein the other vitamin groups comprise: vitamin C; a vitamin E; a vitamin A; vitamin D3.

4. The sea cucumber peptide special medical use formula food as claimed in claim 1, wherein the amount of the added sea cucumber peptide is 1-10 parts by weight, the amount of the added sea cucumber peptide is 5-20 parts by weight, the amount of the added medicinal and edible component is 66-90 parts by weight, the amount of the added natural sweetener is 1-10 parts by weight, and the natural sweetener is arabinose, based on 100 parts by weight of the total weight of the special medical use formula food.

5. The sea cucumber peptide formulated food for special medical use according to claim 1, wherein the sea cucumber peptide formulated food for special medical use is added in an amount of 100 parts by weight based on the total weight of the formulated food for special medical use, wherein the amount of the medicinal and edible components added is: 4-10 parts of white kidney bean protein, 20-30 parts of plantain seed shell powder, 5-10 parts of inulin, 2-5 parts of mulberry leaves, 15-30 parts of konjac glucomannan, 2-5 parts of green coffee and 10-25 parts of quinoa wheat powder.

6. The sea cucumber peptide formulated food for special medical use according to claim 1, wherein the component c) is a refined raw material obtained by pulverizing the medicinal and edible nutritional component according to the added amount of the medicinal and edible nutritional component, extracting, and further filtering and drying the extract.

7. The sea cucumber peptide special medical use formula according to claim 1, wherein the total weight of the component a) mitochondrial nutrients is 5-8% of coenzyme Q10, 15-20% of lipoic acid, 2-4% of acetylcysteine, 2-4% of acetylcarnitine, 25-30% of creatine, 1.3-1.6% of vitamin B group, 3-4% of other vitamin groups, 0.03-0.04% of chromium nicotinate, 8-10% of magnesium glycinate, 25-30% of zinc sulfate and 2-3% of hydroxytyrosol.

8. The sea cucumber peptide special medical use formula food according to claim 7, wherein B1 is 20-22%, B2 is 3-4%, B3 is 41-43%, B5 is 20-22%, B6 is 10-11%, B7 is 0.5-0.7%, B12 is 0.1-0.2%, folic acid is 0.7-0.9% based on the total weight of the vitamin B group.

9. The sea cucumber peptide special medical use formula according to claim 7, wherein the vitamin C is 85-86% and the vitamin E is 11-13% based on the other vitamin groups; vitamin A accounts for 1.5-1.7%; vitamin D3 accounts for 0.03-0.04%.

10. A method for preparing a sea cucumber peptide formulated food for special medical use according to any one of claims 1 to 9, comprising the steps of:

(1) weighing the component b) sea cucumber peptide for later use;

(5) drying the product obtained in the step (4);

(6) packaging the product of the step (5);

11. The method for preparing a sea cucumber peptide formulated food for special medical uses as claimed in claim 10, wherein component b) is a sea cucumber polypeptide liquid prepared from fresh sea cucumber by homogenizing and enzymolysis, and further freeze-drying the polypeptide liquid to obtain sea cucumber polypeptide powder.

12. The method for preparing a sea cucumber peptide formulated food for special medical uses as claimed in claim 10, wherein the product obtained by drying in step (5) is further sterilized by irradiation.

13. The method for preparing a sea cucumber peptide formulated food for special medical uses as claimed in claim 10, wherein the component c) is weighed in step (2), and then the active ingredients of the component c) are extracted by extraction, and the extract is further filtered and dried to obtain a refined component.

14. The method for preparing a sea cucumber peptide formulated food for special medical use according to claim 10, wherein the mixing time in the step (2), the step (3), and the step (4) is 20 minutes to 30 minutes, and the relative humidity of the mixing environment is 50%.

15. The method for preparing a sea cucumber peptide formulated food for special medical uses as claimed in claim 10, wherein the drying temperature in step (5): 60-70 ℃.