WO2012034498A1 - Product of functional health food that enhances organ immunity - Google Patents

Abstract

A functional health food product that enhances organ immunity and controls diabetes comprises active ingredients and auxiliary material. The active ingredients consist of the following: 5 to 10 parts of cordyceps militaris extracts, 35 to 50 parts of grifola frondosa extracts, 20 to 30 parts of lentinan, 5 to 10 parts of pueraria isoflavone, 7 to 15 parts of fructus lycii extracts, and 8 to 20 parts of coprinus comatus. For people in conditions of sub-health, with low immunity or having diabetes, the present product promotes meridian energy flow, lowers blood sugar, controls the onset of diabetic complications, and enhances organ immunity.

Description

 Instruction manual

A product that enhances immunity and can control diabetes

 The invention relates to the field of functional health foods, in particular to a product which enhances immunity of the body and can control diabetes. BACKGROUND OF THE INVENTION Diabetes is a common chronic disease. With the improvement of people's living standards, the aging of the population and the increase in the incidence of obesity, the incidence of diabetes is increasing year by year. According to the report of Jia Chunbao Diabetes Research Institute: At present, the incidence of diabetes in China has reached more than 3%, and the number of diagnosed diabetes patients has reached 45 million, and the rate has increased by about 1.5 million per year. Diabetes is a lifelong disease whose severity is due to a high incidence of complications. People began to pay less attention to diabetes, and complications occurred, and the consequences were quite serious. Podiatry, kidney disease, eye disease, encephalopathy, heart disease, skin disease, and sexually transmitted diseases are the most common complications of diabetes. Studies in the United States have shown that 95% of patients with diabetes for more than 20 years have retinopathy, and those with diabetes die from cardiovascular disease. In addition, people with diabetes may also have kidney disease, neuropathy, digestive tract disease, oral disease, impotence, skin and joint diseases, and lower extremity arteriosclerosis obliterans. Because diabetes can affect all systems of the body, it can cause great mental and physical pain to diabetic patients. The best way to avoid and control diabetes complications is to control blood sugar levels.

 At present, oral hypoglycemic drugs commonly used in clinical practice have side effects, which can cause adverse reactions in the digestive system, and some cause measles, anemia, leukopenia and thrombocytopenia, dizziness and fatigue. Therefore, the search for the development of health foods that enhance the immunity of the body to assist in drug treatment has been attracting attention while effectively controlling blood sugar and diabetic complications while reducing side effects.

Diabetes people are hoping to get rid of this dilemma as soon as possible. At present, reasonable diet and nutrition are still important means to prevent and control diabetes and its complications. Although diabetes may cause various complications, experts pointed out that as long as timely intervention, it can completely prevent and delay the effects of complications, especially to change the lifestyle of modern people who "go out and hit the door to find the elevator". Experts stressed that regardless of diabetes, or cardiovascular complications, genetic inheritance only accounts for 10%, 90% is caused by unhealthy lifestyles such as smoking, exercise, irrational diet, and nervousness. The presence or absence of diabetes complications or its severity plays a decisive role in the life and prognosis of diabetic patients. Therefore, for each diabetic patient to have longevity, effective measures should be taken to prevent the occurrence of comorbidities. Chinese traditional Chinese medicine technology has a long history. The common people also pay great attention to food culture. At the same time of drug treatment, food supplementing and strengthening curative effect are common methods used by the people. However, there is no such healthy food for lowering blood sugar curative effect.

Summary of the invention

 In view of the defects in the above-mentioned fields, the present invention provides a product for enhancing immunity and controlling diabetes, and the raw material completely conforms to the homologous standard of medicine and food, and is capable of enhancing immunity of the body and assisting in controlling diabetes complications. Functional health food.

 A product for enhancing immunity and controlling diabetes, comprising an active ingredient and an auxiliary material, the active ingredient being composed of the following components: 5-10 parts of Cordyceps militaris extract, 35-50 parts of Thousand Buddha extract, shiitake mushroom 20-30 parts of polysaccharide, 5-10 parts of puerarin isoflavone, 7-15 parts of medlar extract, and 8-20 parts of hamweed mushroom extract.

 The active ingredient is composed of the following components: 5-8 parts of Cordyceps militaris extract, 40-45 parts of Thousand Buddha extract, 25-30 parts of lentinan, 6-8 parts of puerarin isoflavone, and 10-15 of medlar extract 10-18 parts of Coprinus comatus extract.

 The active ingredient is composed of the following components: 6 parts of Cordyceps militaris extract, 40 parts of Thousand Buddha extract, 25 parts of lentinan, 7 parts of puerarin isoflavone, 10 parts of medlar extract, and 12 parts of Coprinus comatus extract.

 The adjuvant contains a sweetener.

 The sweetener is stevioside and is 0.2-0.5 parts by weight.

 There are excipients in the excipients.

 The dosage forms are in the form of tablets, capsules, granules, oral liquids, or beverages, tea bags.

 According to the analysis of the background art, most of the diabetes is caused by improper diet. The present invention adopts the principle of homologous medicine and medicine, and preferably selects the above-mentioned raw materials, and makes it into a functional health food, which is beneficial to enhance the immunity of the body, and at the same time The above products have a good preventive and therapeutic effect on complications of diabetic patients.

1, Cordyceps

 Cordyceps militaris is the abbreviation of Cordyceps militaris, also known as Cordyceps militaris or valerian, common name is not old grass, is a medicinal fungus that combines insects and bacteria, modern rare Chinese herbal medicine, Cordyceps militaris belongs to fungi, Ascomycetes, and meat genus. Ergotaceae, Cordyceps. Cordyceps militaris is rich in protein, 18 kinds of amino acids, 17 kinds of trace elements, 12 kinds of vitamins: A, Bl, B2, B6, B12, C, D, E, etc. are higher than mushrooms, and the content of cordycepin in Cordyceps militaris is 0.536 g, and the content of cordycepin in wild Cordyceps is 0.006 g; cordycepin can be used as an anticancer agent, an antiviral agent, an antioxidant, a ribonucleic acid inhibitor, a biologically active substance, an antifungal agent.

The mechanism of action of cordycepin is a strong inhibitory effect on the proliferation of mouse tumor cell lines. Cordycepin can infiltrate into RA and phosphorylate into 3-ATP in cells, which inevitably leads to mRNA absorption and maturation barriers. , affecting the synthesis of proteins, Thereby achieving the effect of inhibiting tumors.

 The efficacy of Cordyceps sinensis: 1, can significantly reduce the ability of mice to resist hypoxia, increase myocardial nutritional blood flow; maintain arrhythmia in rats; have a protective effect on myocardial infarction caused by stress. 2, lowering blood fat and preventing arteriosclerosis, has a comprehensive promotion of hematopoietic function. 3. Promote cellular immunity and inhibit humoral immunity. A novel immunosuppressive agent considered to be an effective element. 4. It has a certain inhibitory effect on mouse gastric cancer and lung cancer. The inhibition rate is 30% to 50%. Intraperitoneal injection has an inhibitory effect on Ehrlich ascites carcinoma and can inhibit carcinogenesis-induced anterior gastric epithelial hyperplasia. 5, there are male hormone-like effects. In addition to its role in gonadal endocrine, it may also work through the nervous system or other aspects. 6. Cardiovascular effects inhibit platelet aggregation. 7. Promote the proliferation of bone marrow hematopoietic stem cells (CFU-3), red progenitor cells (CFU-E BFU-E) and bone marrow fibroblast progenitor cells (CFU-E). 8, silkworm Cordyceps has anti-fatigue, improve the body's immunity, kill cancer cells and so on.

2, thousand bacteria

 Thousand Buddhas, also known as ash tree, chestnut mushroom, porphyra, maitake (Griflola frondosaX yunnan, lotus, etc., belonging to Basidiomycotina, Phytophthora, non-Pleurotus, Polyporaceae, tree flower The genus is a rare food and medicine dual-use bacteria. The maiden is rich in nutrients, and its nutrient content is tested by the Institute of Nutrition and Food Hygiene of the Chinese Academy of Preventive Medicine and the Quality Inspection Center of the Ministry of Agriculture. Contains 25.2 grams of protein (which contains 18.68 grams of 18 amino acids required by the human body, 45.5% of which are essential acids), 3.2 grams of fat, 33.7 grams of dietary fiber, 21.4 grams of carbohydrates, 5.1 grams of ash, and is rich in potassium, phosphorus, and iron. , zinc, calcium, copper, selenium, chromium and other beneficial minerals, rich in vitamins, VE109.7 mg, VB11.47 mg, VB20.72 mg, VC17.0 mg, carotene 4.5 mg, various nutrients It is the first of all kinds of edible fungi, in which the content of VB1 and VE is about 10~20 times higher, the VC content is 3~5 times of its kind, and the protein and amino acid are twice as much as the mushroom, which can promote the healthy growth and wisdom of children. The development of the force, the content of arginine and lysine is higher than the content of lysine (1.024%) and arginine (1.231%) in Flammulina velutipes, and the content of aspartic acid and glutamic acid related to umami. High, so it is known as "North China Ginseng" or even "King of Fungi".

Maitake mushroom (Gray Tree Flower) is not only nutritious, but also has a good health care effect on the human body and anti-cancer, anti-cancer and anti-AIDS effects. In Japan, Maitake is used as a wild herb for the treatment of stomach, esophageal cancer, and breast cancer. According to research by Mr. Sen Kuanyi and others, the oral ash tree flower has a suppression rate of more than 74%. Professor Huang Xingyu from Zhejiang Medical University studied that the anti-cancer effect of Grifola frondosa is mainly B-glucan, accounting for more than 8% of Grifola frondosa. The research report of Prof. Hongbo, Professor of the Kobe Women's Pharmaceutical University in Japan confirmed the resistance of Grifola frondosa to HIV (AIDS). Infected people in the United States daily oral administration of dextran or ash pollen 3 kg, the results showed that 50% of patients with adjuvant T lymphocytes increased for 60 days, 50% of patients help T lymphocytes stop falling, so can It is predicted that Grifola frondosa can suppress or improve the symptoms associated with AIDS. In addition, the ash tree flower is rich in organic selenium, which can be used as a selenium-enriched food. If it is eaten for a long time, it can prevent almost all cancers. Grifola frondosa also inhibits hypertension and obesity and prevents arteriosclerosis. Grifola frondosa contains a large amount of active substances, which can promote liver function, improve fat metabolism, thereby avoiding arteriosclerosis and inhibiting obesity. Symptoms, stabilize blood pressure. Grifola frondosa can promote healthy growth and mental development of children, and can prevent anemia, scurvy, bad blood, rickets and rickets. Grifola frondosa is rich in iron, zinc, calcium, phosphorus and various trace elements. Regular food can avoid a variety of nutritional deficiencies. The lysine content of ash tree flowers can promote children's healthy growth and mental development (accounting for 1.16). %) and arginine (1.25%) are particularly effective for pregnant and lactating women and children, which can make the fetus mentally develop and make the baby smart and strong, so it is called "Zizi Mushroom". In the prevention and treatment of diabetes, organic chromium in Grifola frondosa can help insulin maintain normal glucose tolerance, and has effects on cirrhosis and diabetes. In addition, Grifola frondosa has a good effect on enhancing immunity, promoting growth, delaying aging, increasing memory and sensitivity, and keeping skin smooth.

3, Pueraria Isoflavone

 Pueraria isoflavones are the main functional ingredients in Pueraria lobata extract. Pueraria lobata contains various flavonoids: soy, soy, and soy, 4, 7-diglucoside, puerarin, puerarin-7-wood Glycosides, puerarin, puerarin and isoflavones, etc., the main role is to supplement female estrogen, suitable for adolescence, childbearing and postpartum women, menopausal women. Pueraria isoflavones can shrink smooth muscle, increase coronary blood flow, inhibit platelet aggregation, and lower blood sugar.

Efficacy of Pueraria Isoflavones: 1 Effect on Smooth Muscle Soybean aglycone in Pueraria has an anti-acetylcholine effect and can significantly contract smooth muscle, which is considered to be the main component of Pueraria lobata. 2 Effect on coronary circulation Pueraria decoction, alcohol extract, total flavonoids and puerarin have obvious effects of dilating coronary vessels, which can increase coronary blood flow and reduce vascular resistance. 3 Effects on myocardial infarction and arrhythmia Pueraria extract, soybean aglycone and puerarin have obvious arrhythmia effects induced by aconitine and barium chloride, and puerarin can also significantly shorten chloroform and adrenaline induction. During the arrhythmia of rabbits, puerarin can significantly reduce the extent of myocardial infarction and is considered to be a beta-adrenergic receptor blocker. 4 Effects on cardiac function and myocardial metabolism Pueraria total flavonoids and puerarin can slow heart rate, reduce total peripheral resistance of the heart, reduce myocardial oxygen consumption, and improve myocardial efficiency. Puerarin can also significantly reduce myocardial lactic acid caused by ischemia. Produce and improve the metabolism of infarcted myocardium. 5 Effects on blood pressure and peripheral blood vessels Pueraria radix ketone and puerarin can significantly reduce plasma renin activity and angiotensin, and blood pressure decreases. Puerarin has a significant improvement effect on microcirculatory disorders, mainly manifested by increased microvascular movement. Amplitude and increase local micro-blood flow; total flavonoids from Pueraria lobata have a significant effect on dilating cerebral blood vessels, improving brain microcirculation and peripheral circulation. It has been reported that puerarin can also improve the blockade of retinal vascular end units, thereby improving visual function. 6 inhibition of platelet aggregation puerarin can inhibit adenosine diphosphate (ADP) induction and 5-ΗΤ (5-hydroxytryptamine) combined with ADP induced platelet aggregation in humans and animals; in addition, puerarin can also significantly inhibit the induction of thrombin The release of 5-quinone in platelets has an antithrombotic effect. 7 The role of hypoglycemia Puerarin can counteract the agglutination of epinephrine and has a certain ability to lower blood sugar. 8 Effect on body temperature The total flavonoids of Radix Puerariae have a long-lasting and obvious cooling effect on the increase of body temperature caused by endotoxin. It is often used in external fever and fever. 9 Effects on memory Total flavonoids and alcohol extracts can increase acetylcholine content in rat cerebral cortex and hippocampus, and decrease hippocampal acetylcholine transferase activity against scopolamine-induced memory-acquired disorder in rats. Has a certain ability to improve learning and memory.

 4, lentinan

 Lentinus edodes polysaccharide is an effective ingredient in mushroom extract. Mushrooms are also known as citron, vertebral ear, sweet letter, winter glutinous rice, thick mushroom, flower mushroom, English Name: Lentinat Mushroom is rich in nutrients and delicious, and is regarded as the "king of mushrooms". It contains lentinan (structured as follows). There are more than ten kinds of amino acids, including 7 kinds of essential amino acids such as isoleucine, lysine, phenylalanine, methionine, threonine and proline. Bl, B2, PP and mineral salts.

 Lentinus edodes polysaccharide is an effective active ingredient extracted from high-quality mushroom fruit body. The main components of shiitake mushroom are polysaccharides and unsaturated fatty acids, and also contain a large amount of ergosterol and mycohol which can be converted into vitamin D. It can regulate the immune function of T cells in the human body, which can reduce the ability of methylcholine to induce tumors. Mushrooms have a strong inhibitory effect on cancer cells, with an inhibition rate of 97.5% for mouse sarcoma 180 and 80% for Ehrlich cancer.

 5, scorpion

 Since ancient times, Scorpion has been the top grade for nourishing and supporting people. It has the effect of prolonging the decline and resisting the old, so it is also known as "the old man." It has the functions of nourishing liver and kidney, nourishing liver and clearing the eye. It is often used together with rehmannia, chrysanthemum, yam, hawthorn and other medicines. Scorpion is also a good solution for strengthening the body, replenishing the marrow, nourishing yin and tonifying the kidney, replenishing qi and calming the nerves, strengthening the body, and delaying aging. It has a remarkable effect on chronic hepatitis, central retinitis, optic atrophy, etc.; for diabetes, tuberculosis, etc. It also has a good effect; it has a strong improvement effect on aging diseases such as anti-tumor, liver protection, blood pressure reduction, blood sugar lowering and organ decay in the elderly. As a nourishing and strong agent for the treatment of kidney deficiency and liver and kidney disease, it has a very good effect, which can significantly improve the plasma testosterone content in the human body and achieve the effect of strengthening the body. Modern medical research has shown that strontium has a significant inhibitory effect on extracellular cancer cells and can be used to prevent the spread of cancer cells and enhance the body's immune function. Modern analysis shows that the scorpion contains a very rich camp, containing 4.49 grams of crude protein per 100 grams of fruit, 2.33 grams of crude fat, 9.12 grams of carbohydrates, 96 mg of carotenoids, 0.053 mg of thiamine, nuclear yellow. 0.137 mg, ascorbic acid 19.8 mg, betaine 0.26 mg, rich in potassium, sodium, calcium, magnesium, iron, copper, manganese, zinc and other elements, as well as 22 amino acids and multivitamins. Among them, the 枸杞 polysaccharide functional factor has a very important and multi-faceted health function:

 (1) Immunomodulation 枸杞 Polysaccharide has a very significant immunomodulatory effect on non-specific immunity and specific immunity in mice, which can significantly enhance mouse spleen lymphocyte proliferation, delayed type hypersensitivity, and increase serum hemolysin content in mice. , mouse peritoneal macrophage chicken red blood cell function, mouse carbon clearance ability, and ability to significantly enhance antibody production.

 (2) Hypoglycemic effect Lycium barbarum polysaccharide has obvious hypoglycemic effect on experimental diabetes, the effective rate is up to 100%; and it has no effect on blood sugar in normal mice.

(3) hypolipidemic effect 枸杞 polysaccharide has a significant effect on the blood lipids of experimental hyperlipidemic rats, can significantly reduce serum cholesterol, triglyceride content, and has a higher effect on high-density lipoprotein. The experimental results show that the polysaccharide has obvious regulation of blood lipids. (4) Anti-aging effect Drosophila survival test showed that alfalfa polysaccharide can significantly prolong the average life expectancy and maximum life span of female and male fruit flies. It also significantly increased the role of SOD in mouse red blood cells and significantly reduced MDA. In addition, animal and clinical trial results show that lycium barbarum polysaccharide can significantly enhance the cellular immune function of dethymus mice, and also has a certain recovery effect on mouse sexual function.

 (5) Anti-fatigue effect The polysaccharide can increase the muscle glycogen and liver glycogen reserve of experimental mice. Increasing the total activity of lactose deamination, accelerating the clearance of blood urea and lowering the blood lactate level after exercise can significantly prolong the swimming time of mice. Therefore, the polysaccharide can enhance the body's physical strength and quickly eliminate fatigue after exercise.

 (6) Other effects Tests on gastrodia elata, ginseng, ginkgo biloba, and alfalfa extracts showed that: alfalfa extract can significantly prolong the survival time of animals under hypoxic conditions and under irradiation conditions.

 6, chicken legs

 Coprinus comatus is a common name for chicken leg mushrooms. It is named after chicken legs and meaty meat like chicken. It is a rare and rare product with commercial potential developed in recent years. It is known as "a rookie in bacteria". Scientific name: Maotou ghost umbrella. Alias: Coprinus comatus, thorn mushroom Latin name: Copyinds comatus (MUII. Fr) Gray, classification status: belonging to Basidiomycetes, Agaric, Coprinus, Coprinus.

 The chicken leg mushroom is flat, sweet and smooth, with clearing spirit, benefiting the spleen and stomach, helping digestion, increasing appetite and other effects. Coprinus comatus also contains anti-cancer active substances and active ingredients for the treatment of diabetes. Long-term consumption has a good effect on lowering blood sugar concentration and treating diabetes, especially for treating acne.

 Because of the nutrition, health care and therapeutic treatment, the chicken leg mushroom has the excellent characteristics of high protein and low fat. And color, fragrance, taste shape is good. According to the "Chinese Medicinal Fungi Picture Book" and other books, the hot water extract of Coprinus comatus has a inhibition rate of 100% and 90% for the sarcoma 180 and Ehrlich cancer. The specific nutrients of dried koji mushroom are: total sugar content is 57.65%, reducing sugar is 53.54%, protein is 24.45%, crude fat is 2.82%, crude fiber is 2.78%, ash is 10.8%, and moisture is 0.2%. Because of its certain nutritional value and delicious taste, Coprinus comatus is favored by consumers, so the fresh product is 2-3 times higher than the price of oyster mushrooms. It is a rare edible fungus.

 7, stevioside

The main ingredient in stevioside is stevioside, which is widely used in various foods, beverages, medicines, and the chemical industry as a new type of sweetener. It can be said that almost all sugar products can be replaced with stevia to replace some sucrose or all of the chemical sweeteners such as saccharin. The stevioside having a purity of 80% or more of stevioside is white crystal or powder, and has little hygroscopicity. Soluble in water, ethanol, and mixed with sucrose, fructose, glucose, maltose, etc., not only the stevia flavor is more pure, but the sweetness can be multiplied. The sugar has poor heat resistance, is not easy to be lighted, and is very stable in the pH range of 3 to 10, and is easy to store. The stability of the solution is good, and the heat treatment is still stable in the pH range of the general beverage food. Stevioside has little change in semi-annual storage in sucrose-containing organic acid solution; it does not decompose in acid-base medium to prevent fermentation, discoloration and precipitation; it can reduce viscosity, inhibit bacterial growth and prolong product shelf life. When it is used with citric acid, malic acid, tartaric acid, lactic acid, and acid, amino acid, it has a killing effect on the aftertaste of stevioside. Therefore, in combination with the above substances, it can play a flavoring effect and improve the sweetness quality of stevia.

 Efficacy characteristics 1, high security. Residents of stevioside origin (South America, Paraguay, Masi, etc.) have been eating for hundreds of years and have not found any poison. 2. Low calorific value. It is used to make low-calorie foods and beverages, and is very suitable for patients with diabetes, obesity, and arteriosclerosis.

 The traditional Chinese medicine meridians said that with the rise of modern living standards, the pace of life is accelerating, smoking, heavy drinking, high-calorie diets and other unhealthy lifestyles, as well as social and psychological factors such as depression, tension, anxiety, etc., can cause metabolic imbalance and body Neuro-endocrine-immune network disorders lead to diseases such as hypertension, hyperlipidemia, and diabetes. Diabetic peripheral neuropathy is a typical pathological process of gastro-intestinal disease caused by choroidal lesions. The qi and blood block in the collaterals is the key to the onset, and it runs through. Diabetes complicates the pathogenesis of blood stasis, and the enthusiasm and enthusiasm cement each other. Therefore, the product of the invention adopts the effects of Cordyceps militaris, Thousand Buddha, Puerarin isoflavones, medlar to lower blood fat and lower blood sugar, and has the functions of preventing arteriosclerosis, improving fat metabolism, smoothing blood circulation, cleaning and preventing stasis, To prevent and control the role of diabetes, and to prevent the occurrence of cardiovascular complications; the use of Cordyceps militaris, Thousand Buddha, lentinan to improve the immune system, so that people with diabetes improve their immunity, reduce the occurrence of complications; The medlar is a nourishing top grade. Combining Cordyceps militaris can enhance the physical disability caused by kidney deficiency in diabetic patients, improve the anti-fatigue ability, improve the patient's exercise capacity, make the qi and tongs, the scorpion also protects the liver, and the eye disease is remarkable. Efficacy, prevention of eye disease complications; combined with high protein, low calorie mushrooms, Coprinus comatus as a nutrient, to enhance exercise, while getting a reasonable nutritional supplement, Coprinus comatus can also adjust the spleen and stomach, help digestion, reduce food accumulation . Therefore, the present invention selects the food combinations of the above-mentioned several medicines and foods to make the gas and blood vessels smooth, not only can enhance the body immunity, lower blood sugar, and at the same time, diabetic nephropathy, neuropathy, digestive tract diseases, oral diseases. Complications such as impotence, skin and joint diseases, and lower extremity arteriosclerosis obliterans have a good effect. Early and mild patients can better control the occurrence of diabetic complications.

 In order to improve the mouthfeel of the above composition, the present invention is added with stevioside, and as a sweetener, it does not improve the blood sugar of the patient, and at the same time, when used in combination with other extracts, it has a flavoring effect and can appropriately extend the product. Shelf life.

The present invention is mainly used for oral administration, and can be formulated into conventional solid preparations including tablets, capsules, granules, pills, oral solutions, and the like. Tablet refers to a solid preparation of tablets or shaped tablets which are mixed with a suitable excipient and a suitable excipient; the tablets are mainly oral tablets, and include tablets, sublingual tablets, oral patches, and chewable tablets. , dispersible tablets, soluble tablets, effervescent tablets, sustained release tablets, controlled release tablets and enteric coated tablets. Capsule refers to a solid preparation filled with a drug or an auxiliary material filled in a hollow capsule or sealed in a soft capsule; the capsule can be classified into a hard capsule (commonly known as a capsule) and a soft capsule (a capsule according to its dissolution and release characteristics). ), sustained release capsules, controlled release capsules and enteric capsules. Granules refer to pharmaceuticals and suitable excipients to form dry granular preparations having a certain particle size; granules can be divided into soluble particles (commonly known as granules), suspended granules, effervescent granules, enteric granules, sustained release granules and Controlled release granules, etc. Pill means a spherical or spheroidal solid preparation which is uniformly mixed with a suitable excipient and is prepared by a suitable method; the pill includes a dropping pill, a sugar pill, a pellet, and the like. mouth By solution is meant a clear liquid preparation in which the drug is dissolved in a suitable solvent for oral administration.

 The preparation of the present invention can be produced by a conventional method in the field of the prior art, and various pharmaceutically acceptable carriers can be added as needed. The carrier includes a conventional osmotic pressure adjusting agent, a pH adjusting agent, a solubilizing agent, an antioxidant, a bacteriostatic agent, an emulsifier, a suspending agent, a filler, a binder, a disintegrating agent, and a lubricant in the pharmaceutical field. Etc., is part of the excipients of the present invention. In the preparation of the oral preparation of the present invention, a suitable filler, a binder, a disintegrant, a lubricant and the like may be added. Fillers include starch, powdered sugar, calcium phosphate, calcium sulfate dihydrate, dextrin, microcrystalline cellulose, lactose, pregelatinized starch, mannitol, etc.; binders include sodium carboxymethylcellulose, PVP-K30 , hydroxypropyl cellulose, starch syrup, methyl cellulose, ethyl cellulose, hypromellose, gelatinized starch, etc.; disintegrants include dry starch, crospovidone, crosslinked carboxymethyl fiber Sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, etc.; lubricants include magnesium stearate, talc, sodium lauryl sulfate, micronized silica gel, and the like.

 The operation of the aqueous extract of the active ingredient of the traditional Chinese medicine carried out in the examples and the specific content of the added excipients are all conventional techniques in the art, and are easily realized by those skilled in the art, and there is no problem of insufficient disclosure. The purpose of the examples is to demonstrate that the compositions of the present invention can be formulated into conventional dosage forms, and are not intended to limit the scope of their protection or to affect their disclosure.

 The product of the invention adopts Cordyceps militaris extract, Thousand Buddha extract, Lentinus edodes polysaccharide, Pueraria lobata extract, Lycium barbarum extract and Coprinus comatus extract as active ingredients thereof, so that sub-healthy people, immunocompromised people and diabetic patients It is a functional health food that can control the occurrence of diabetic complications and enhance the body's immunity while achieving blood sugar lowering. detailed description

Raw materials:

 Cordyceps militaris extract, Thousand Buddha extract, medlar extract and Coprinus comatus extract are extracted with water as a solvent, and extracted by conventional water extraction method of traditional Chinese medicine.

 Lentinus edodes polysaccharide, puerarin isoflavone, stevioside is a commercially available product.

Example 1

 Cordyceps militaris extract 60g, Thousand Buddha extract 400g, lentinan 250g, Pueraria isoflavone 70g, medlar extract 100g, Coprinus comatus extract 120g, capsules were prepared according to conventional methods.

Example 2

 Cordyceps militaris extract 50g, Thousand Buddha extract 500g, Lentinus edodes polysaccharide 200g, Pueraria lobata 100g, Lycium barbarum extract 70g, Coprinus comatus extract 150g, add appropriate amount of stevioside, mix and mix, and prepare granules according to the conventional method.

Example 3

Cordyceps sinensis extract 100g, Thousand Buddha extract 350g, lentinan 300g, Pueraria isoflavone 50g, medlar extract 150g, Coprinus comatus extract 80g, mixed in lOOKg water, add appropriate amount of stabilizer, stevioside can be seasoned . Example 4

 Cordyceps sinensis extract 80g, Thousand Buddha extract 450g, Lentinus edodes 200g, Puerariae isoflavone 80g, Lycium barbarum extract 80g, Coprinus comatus extract 200g, mixed in lOOKg water, add appropriate amount of stabilizer, stevioside can be seasoned .

Experimental example: Experimental results of hypoglycemic functional animals in the health food: ("Technical Specifications for Health Food Inspection and Evaluation", Ministry of Health, Chinese People's Republic of China, 2003 Edition) 1. 1 Materials

 1. 1. 1 test substance: The health food prepared in the first embodiment has an active ingredient weight of 720 mg/d per day, which is 12 mg/kg body weight, based on 60 kg body weight of an adult.

 1. 1. 2 Test animals: Adult rats weighing 180g ± 200g, male, 100 were purchased from Hubei Experimental Animal Research Center, and the certificate number is No. 2009-0810.

 1. 1. 3 dose selection: The experiment consists of three dose groups: 10 times human intake low dose group, 20 times human intake medium dose group, 30 times human intake high dose group and high blood glucose model control group . The oral volume of the mice was 0.2 ml/10 g body weight. Test subject time

1. 1. 4 main instruments and reagents: blood glucose meter, automatic biochemical analyzer, 721-B spectrophotometer; alloxan, fresh preparation before use.

1.2 Experimental methods

1.2.1 Glucose tolerance test

 (1) Hyperglycemic model animals

 1 Principle Alloxan is an islet cell cytotoxic agent that selectively damages islet cells of various animals, resulting in low insulin secretion and causing experimental diabetes.

 2 After the model animals were fasted for 24 hours, the alloxan was given. The administration method is as follows: the mice are intravenously injected with alloxan 35 to 50 mg/kg body weight, and the rats are intravenously injected with alloxan 50 to 80 mg/kg body weight. After 5~7d, fasting for 3~5h, measuring blood sugar, blood glucose value reached 10~25mmol/L, which is successful modeling.

(2) Determination of glucose tolerance test The hyperglycemic model animals were fasted for 3 to 5 hours. The dose group was given different concentrations of the test substance, and the model control group was given the same volume of solvent. After 15 to 20 minutes, glucose was 2.0 g/kg orally, and blood glucose levels of 0, 0.5 h, and 2 h after glucose administration were measured, and the area under the blood glucose curve at each time point was observed after the model control group and the test group were given glucose. The change. Area under the blood glucose curve = 丄(Α ₀ +Α ₀ · ₅ ) X 0. 5+ (A2+A0 X I. 5 = 0. 25 (A.+4A.. ₅ + 3A ₂ )

 2 Note: In order to make the test animal's function of glucose metabolism as consistent as possible, and in order to accurately calculate the dosage of the test substance by weight, the animals should be strictly fasted before the test (cannot be prohibited), the fasting conditions should be consistent before and after the test, the rats Classes should be replaced with padding while fasting. 1.3 blood glucose determination method (glucose oxidase method)

1.3.1 Principle Glucose oxidase is an aerobic dehydrogenase that catalyzes the production of glucose by gluconic acid and hydrogen peroxide. The latter releases oxygen under the action of peroxidase, which in turn oxidatively condenses 4-aminoantipyrine with a phenol to form a red terpenoid which can be measured by colorimetric at a wavelength of 505 nm.

1.3.2 reagent preparation

1 0.2 mol/L phosphate buffer (pH 7.0): 0.2 mol/L Na ₂ HP0 ₄ 61 mL may be mixed with 0.2 mol/L KH ₂ P0 ₄ 39 mL.

 2 Enzymes: glucose oxidase 400U, peroxidase 0.6mg, 4-aminoantipyrine 10mg, sodium azide lOOmg, phosphate buffer to lOOmL, pH adjusted to 7. The refrigerator can be stored for at least 2 months.

 3 Phenol reagent: Dissolve 100 mg of phenol in 100 mL of distilled water.

 4 Enzyme mixing reagent: Mix the same amount of enzyme reagent and phenol reagent. It can be stored in the refrigerator for 1 month.

 5 Glucose standard stock solution: Anhydrous D-glucose (AR) is baked in an oven at 80 ° C for 4 h, cooled and stored in a desiccator to constant weight. Accurately weigh 2g, dissolve it in 0.25% benzoic acid solution, transfer it to a lOOmL volumetric flask, and dilute to 100mL with benzoic acid solution.

6 Use liquid: Accurately add 5mL of stock solution in lOOmL volumetric flask, dilute to lOOmL with 0.25% benzoic acid solution, that is, use lmg/mL.

7 Protein precipitant: Dissolve 10 g of disodium hydrogen phosphate, 10 g of sodium tungstate, 9 g of sodium chloride in 800 mL of distilled water, add 125 mL of 1 mol/L hydrochloric acid, and dilute to 1000 mL with distilled water. 1.3.3 Operation steps

 Take 1 mL of protein precipitant, add 50 μL of plasma (serum), and mix. After standing at room temperature for 7 min, centrifuge and take the supernatant (no blood filtrate) for determination. The same treatment was also carried out for the glucose standard use solution. Follow the procedure in Table 1. Table 1 Operation steps of glucose oxidase method for measuring blood glucose I mL

 After mixing, heat in a 37 ° C water bath for 15 min, adjust the zero point with a blank tube, and calculate the colorimetric value at the wavelength of 505 nm.

In the formula 18, AA ₂ represents the absorbance values of the measuring tube and the standard tube, respectively. The experimental results of the hypoglycemic functional animals of the health food are shown in Table 2:

 Table 2 Effect of the health food on glucose tolerance in hyperglycemic model mice (¥士 SD) Group Animals only Glucose levels after glucose (mmol/L) Glucose curve

 Oh 0.5h 2h area

Hyperglycemia model 24.4 ±5.6 41.4 ±5.8 28.2 ±7.0 68± 10

 Low dose group 20.7±7.1 34.4 ±6.2 23.1 ±8.2 60士 12

 Medium dose group 18.8 ±7.3 32.8 ±6.3* 21.7±7.3 53 ± 12

 High dose group 19.0±5.1 32.0 ±5.0* 20.2 ±6.4 52士 10

* Compared with the blank control group, there was a significant difference (P<0.01). The oral administration of different doses of the health food for 31 days was compared with the hyperglycemic model control group, and the middle dose group was able to reduce the blood glucose level after glucose administration ( P<0.01), reduce the area under the blood glucose curve of 0~2h after glucose administration (P<0.05); high dose group can reduce After glucose administration, the blood glucose level was 0.5 h (P < 0.05), and the area under the blood glucose curve after 0 to 2 h was decreased (P <0.05); and the test article had no effect on the body weight of mice and fasting blood glucose in normal mice. Bad effects. According to the "Technical Specification for Health Food Inspection and Evaluation" (2003 edition), the criteria for determining the blood sugar lowering function health food can be judged as positive for the blood sugar lowering function of the health food.

Experimental Example 2: The blood sugar lowering function of the health food product results in human experiment:

Case selection and clinical observation The human body experiment of hypoglycemic function of the health food of the present invention was carried out in 30 cases systematically, and 7 cases of diabetes patients with the same medical history, condition, age, sex and original treatment method were selected as the control group. The selected cases from the inpatient and endocrinology clinics were confirmed to be adult diabetic patients according to the diagnostic criteria for diabetes established by the Ministry of Health in 1980. On the basis of oral hypoglycemic agents and insulin therapy, fasting blood glucose was 7. 2mm ₀ l/L. Observed subjects, including 15 males and 15 females, aged 40 to 55 years old. The course of disease is half a year ~ 15 years.

 Test group: On the basis of the original treatment, the hypoglycemic agent was deactivated, and the health food prepared in Example 4 of the present invention was used. The recommended amount of the active ingredient per adult was 720 mg/d o per day, which is 12 mg/kg body weight.

 Control group: According to the conventional hypoglycemic treatment, the dosages of the hypoglycemic drugs and the varieties were matched with the test.

 The fasting blood glucose was regularly checked by the same method, and the observation period was three months, and one month was a course of treatment. A total of three courses.

The experimental results are shown in Table 3.

 Table 3 Changes in blood glucose before and after taking the health food of the present invention

 It can be seen from Table 3 that the fasting blood glucose concentration and the amount of hypoglycemic drugs before the two groups were basically similar, P>0.05, the blood glucose of the experimental group was decreased after taking the health food of the present invention, and the amount of hypoglycemic medicine was reduced by 1/ 3 to 1/2.

 According to the "Technical Specification for Health Food Inspection and Evaluation" (2003 edition), the criteria for determining the blood sugar lowering function health food can be judged that the human body experiment results of the health food product indicate that the blood sugar lowering function is obvious.

Experimental Example 3: We also measured the immune function of the test diabetic patients before and after taking the health food prepared in Example 4 of the present invention. Relevant data, and compared with normal people, the results are shown in Table 4.

Table 4 T cell subset determination results

The method for detecting the tau cell subset is to use a conventional alkaline phosphatase anti-alkaline phosphatase method. The measurement data showed that the okT ₃ was significantly higher than that of the normal person before taking the drug of the present invention, and the okT ₄ /okT ₃ ratio was significantly decreased. After taking the health food of the present invention, both of them substantially returned to normal, indicating that the health food of the present invention has Enhance the body's immune function.

Experimental example 4

 The functional test standards for enhanced immunity of this health care product are based on the "Technical Specifications for Health Food Inspection and Evaluation" (2003) of the Ministry of Health. The test results are as follows:

1. Materials and methods

 1.1 Test material: The product of the invention obtained in Example 3 of the present invention; the recommended amount for adults is 2 g/d per day. According to the adult 60kg body weight, that is, 33mg / (kg * body weight).

 1.2 Test animals: Clean grade BALB / c mice, male, 200, 18~22g, purchased from Hubei Experimental Animal Research Center, and the syndrome number is No. 2006-0812.

 1.3 Dose selection: The experiment consists of three dose groups: 10 times human intake [0.33g / (kg * weight)] group, 20 times human intake

 [0.67g / (kg * body weight)] group, 30 times human intake [l.OOg / (kg * body weight)] group and control group. The volume of the mice was 0.2 ml / 10 g · body weight.

1.4 Main instruments and reagents: 5mm diameter puncher, microscope, micro blood coagulation test plate, centrifuge, microplate reader, 96-well culture plate, 5% CO ₂ incubator, 200 mesh sieve, ink for injection, bean Protein A (ConA), MTT, DNFB, Acetone, Sesame Oil, Depilatory Agent, SPBS, Saline, Chicken Red Blood Cell, Methanol, Giemsa Dyeing Solution, YAC-1 Cell, Hanks Liquid (pH 7.2~7.4), RPMI 1640 Complete Culture Liquid, lithium lactate, iodine nitrotetrazolium chloride (INT), phenazine dimethyl sulfate (PMS), NAD, Tris-HCI buffer (pH 8.2) 1 NP40 trypan blue, 1 mol/L Hydrochloric acid, etc.

1.5 experimental methods

1.5.1 Carbon clearance test and organ/body weight ratio determination: At the end of the experiment, after the mouse is stabilized, the diluted body is injected from the tail vein of the mouse according to the body weight. Indian ink (100 mL/kg), 2, lOmin after injecting the ink, took 20 uL of blood from the internal iliac venous plexus, and immediately added it to 2 mL of 0.1% NaCO ₃ solution. The optical density value (0D) was measured at 600 nm using a 721 spectrophotometer, and the NaCO ₃ solution was used as a blank control. The mice were sacrificed, the animals were dissected, the liver, spleen and thymus were removed, and the blood stains were dried with filter paper and then stabilized.

 1.5.2 delayed type hypersensitivity (DTH): After the test material was continuously administered to the mice for 30 days, the skin of each mouse was depilated with a depilatory agent, the range was about 3 cm×3 cm, and then sensitized evenly with 50 uL of DNFB solution; After 5 days, the DNFB solution was evenly applied to both sides of the right ear of the mouse to attack. After 24 hours, the mice were sacrificed by cervical dislocation, and the left and right ears were cut out, and the ear piece with a diameter of 5 mm was removed by a puncher.

1.5.3 Determination of half-hemolytic value (HC _5Q ) and antibody-producing cell assay (Jeme modified slide method): After the test material was administered to mice for 30 days, each intraperitoneal injection of 2% (volume fraction) of SRBC cells 0.2 mL of the suspension was used for immunization. After 5 days, half of the hemolysis value (HC _5Q ) and antibody-producing cells were detected in the blood and spleen of the mice.

1.5.3.1 Determination of half hemolysis value (HC _5Q ): The mice were removed from the eyeball and blood was taken from the centrifuge tube, placed for about 1 h, the serum was precipitated, centrifuged at 2000 r / min for 10 min, and serum was collected. The serum was diluted with physiological saline (300 times), and the diluted serum 1 mL was placed in a test tube, and 10% (volume fraction) SRBC 0.5 mL, 1 mL of complement (diluted 1:10 with physiological saline) was added in sequence, and no serum was added. The control tube (replaced with physiological saline) was incubated in a constant temperature water bath at 37 ° C for 15 to 30 minutes, and then the reaction was terminated by an ice bath. Centrifuge at 2000r / min for 10 min, take 1 mL of the supernatant, add 3 mL of Dud reagent to the test tube, and take 10% (volume fraction) SRBC 0.25 ml Addition of Dud reagent to 4 mL. Mix in another tube and mix thoroughly. After lOmin was placed, the control tube was blanked at 540 nm, and the optical density values of the respective tubes were measured.

1.5.3.2 Antibody-producing cell assay (Jeme modified slide method): Take the spleen of mice after 5 days of SRBC immunization, place in a small dish containing Hanks liquid, gently grind the spleen, and filter through a 200 mesh screen. Into a single cell suspension. After centrifugation for 10 min (1000 r/min), the cells were washed twice with Hanks, and the cells were suspended in 5 mL of RPMI 1640 medium, the cells were counted, and the cell concentration was adjusted to 5×10 ⁶ /mL. After heating and dissolving the surface medium, mix it with an equal amount of pH 7.2~7.4, 2 times concentration of Hanks solution, dispense small tubes, 0.5 mL per tube, and then add 50 uL of 10% SRBC, 20UL spleen cell solution to the tube, quickly Mix well, pour on the slide of the thin layer of agarose, make a parallel piece. After the agar solidifies, place the slide on the rack, incubate in the C0 ₂ incubator for l~1.5h, count the hemolysis Number of plaques.

1.5.4 Mouse peritoneal macrophage phagocytosis chicken red blood cell experiment (half-in vivo method): After the test material was continuously administered to mice for 30 days, each mouse was intraperitoneally injected with 2% chicken red blood cell suspension lmL. After 30 minutes, the animal was sacrificed by cervical dislocation. The animal was fixed on the wax plate in the supine position. The skin of the abdominal wall was cut in the middle. 2 mL of normal saline was injected into the abdominal cavity, and the mouse plate was rotated for 1 min. Then, 1 mL of the peritoneal washing solution was aspirated, and the average was divided into 2 slides. Place in an enamel box with wet gauze and incubate at 37 °C for 30 min. Incubate, rinse in physiological saline, remove unpatched cells, dry, and fix with 1:1 acetone solution for 20 min. 4% (volume fraction) stained with Giemsa-phosphate buffer for 3 min, then steamed The distilled water is rinsed and dried, and the macrophages are counted under a microscope.

 1.5.5ConA-induced spleen lymphocyte transformation test and mouse NK cell activity assay (lactate dehydrogenase LDH assay): After the test material was given to the mice for 30 days, the cervical vertebrae were dislocated and the spleen was aseptically taken. Place in a small plate filled with appropriate amount of sterile Hanks solution, gently smash the spleen with tweezers, filter through a 200 mesh sieve, and make a single cell suspension. The cell suspension is divided into two parts and induced in ConA. Mouse spleen lymphocyte transformation assay and mouse NK cell activity assay.

1.5.5.1 ConA-induced mouse spleen lymphocyte transformation experiment: Wash the cell suspension with Hanks solution twice, each time centrifugation

After 10 min (1000 r/min), the cells were suspended in 1 mL of complete medium, and the number of viable cells (over 95%) was counted by trypan blue staining, and the cell concentration was adjusted to 3×10 ⁶ cells/mL. Each cell suspension was added to a 24-well culture plate in two wells, 1 mL per well, one well was added with 75 uL of ConA solution, and the other well was used as a control, and cultured in an incubator for 72 hours. 4 h before the end of the culture, 0.7 mL of the supernatant was aspirated per well, and 0.7 mL of serum-free RPMI 1640 medium was added thereto, and MTT 50 uL/well was added thereto, and the culture was continued for 4 hours. After the completion of the culture, 1 mL of acidic isopropanol was added to each well, and the mixture was blown and mixed to completely dissolve the purple crystals. Then, they were dispensed into a 96-well culture plate, and three parallel holes were made per well, and the optical density value was measured by a microplate reader at a wavelength of 570 nm.

1.5.5.2 Determination of mouse NK cell activity (Lactate dehydrogenase LDH assay): The target cells were subcultured 24 h before the test, washed three times with Hanks before application, and adjusted to a cell concentration of 4 X 10 with RPMI 1640 complete medium. ⁵ / mL. The spleen cell suspension was washed twice with Hanks solution and centrifuged for 10 min (1000 r/min) each time. After discarding the supernatant, add 0.5 mL of sterilized water for 20 s, lyse the red blood cells, then add 0.5 mL of 2 times Hanks' solution and 8 mL of Hanks' solution, centrifuge for 10 min (1000 r/min), resuspend with 1 mL of complete medium, and dilute with 1% glacial acetic acid. After counting, trypan blue staining counts the number of viable cells (should be above 95%) and adjusts the cell concentration to 2 X 10 ⁷ cells/mL. Take 100uL of target cells and effector cells (effective target ratio 50: 1), and add to 96-well culture plates; target cells naturally release wells plus target cells and 1% NP 40 each 100uL, each of which has three replicate wells. Incubate in a 37 ° C, 5% CO ₂ incubator for 4 h, then centrifuge the plate (1500 r / min) for 5 min, take the supernatant lOOuL per well into a 96-well culture plate, add LDH substrate solution 100uL, reaction for 3min 1 mol/L of HCI 30 uL was added to each well, and the optical density value was measured at 490 nm. Experimental data statistics: The experimental data were analyzed using SAS software.

2. Results

 2.1 The effect of the health care product of the present invention on the body weight of mice, the results are shown in Table 5 to Table 9. Table 5 Animal weight record before and after the organ clearance/body weight test (¥ ± S)

 Group and dose Number of animals 1 body weight / g weight gain / g / [g (kg · body weight)] before the test

 Control group 10 18.4 ± 1.3 22.3 + 1.2 3.9 ± 0.8

0.33 10 18.5 士 1.4 21.8 士 1.3 3.3 ± 0.6

0.67 10 18.6 ± 1.3 22.1 + 1.5 3.5 ± 0.8 1.00 10 18.3 ± 1.4 21.9 ± 1.4 3.6 ± 0.5

 Table 6 Animal weight records before and after D TH experiment (¥ ±S)

 Group and dose Number of animals 1 body weight / g weight gain / g

 /[g(kg ·weight)] before the test

 Control group 10 18.5 ± 1.4 22.3+ 1.5 3.8 士 1.0

 0.33 10 18.4士 1.2 21.8士 1.3 3.4±0.8

 0.67 10 18.5 士 1.3 22.1+ 1.6 3.6+ 1.0

 1.00 10 18.6 士 1.4 21.8 士 1.5 3.2 ±0.9

Table 7 Half-hemolytic value (HC ₅ ). Animal and body weight cell records before and after antibody-producing cell experiments (X S)

After analysis of variance, there was no significant difference between the three dose groups and the control group before and after each test, body weight and weight gain, P>0.05. 2.2 The effect of the product of the invention on the body weight ratio of the mouse organ I, the results are shown in Table 10. Table 10 Effect of the product of the present invention on the organ/body weight ratio of mice (X Shi S)

Note: * indicates that compared with the control group, P < 0.05

 The spleen/body weight ratio was analyzed by variance, F = 0.40, P > 0.05. The thymus/body weight ratio was analyzed by analysis of variance, F = 3.20, P < 0.05. Q test, the 30-fold dose group recommended by the human body was significantly different from the control group, P < 0.05.

2.3 The effect of the product of the present invention on mouse cellular immune function [mouse spleen lymphocyte transformation experiment and mouse delayed type hypersensitivity (DTH)] is shown in Table 11. Table 11 Effect of the product of the present invention on cellular immune function of mice (X Shi S)

Note: * indicates comparison with the control group P<0.05

 The 0D difference of the lymphocyte proliferation test was analyzed by analysis of variance, F = 2.86, P < 0.05. In the Q test, the three dose groups recommended by the human body were compared with the control group, P < 0.05, and there was a significant difference. The degree of ear swelling was analyzed by analysis of variance, F = 3.42, P < 0.05. According to the Q test, the 30-fold dose group of the human body recommended was compared with the control group, P < 0.05, and there was a significant difference.

2.4 The effect of the product of the present invention on humoral immune function (measurement of antibody-producing cells and determination of half-hemolytic value in mice) of mice is shown in Table 12. Table 12 Effect of the product of the present invention on humoral immune function of mice (¥ ± S) Group and dose antibody-producing cell assays (number of hemolytic plaques / half hemolysis value (HC ₅₀ )

/[g(kg·weight)] number of animals 1 only 10 ⁶ spleen cells)

 Control group 10 264 士 60 155.08 ±9.88

0.33 10 356 ±66* 159.02 ±7.83

0.67 10 343 ±78* 156.59 ±8.08

1.00 10 348 ±54* 169.56士 11.23** Note: * indicates P<0.05 compared with the control group, ** indicates that compared with the control group, P<0.01

The number of hemolytic plaques was analyzed by variance, F=4.33, P<0.05. Q test, the three dose groups compared with the control group, there was a significant difference, P <0.05; HC ₅ . After analysis of variance, F = 4.88, P < 0.01. Q test, 30 times the dose group compared with the control group, there was a significant difference, P <0.01.

 2.5 The effect of the product of the invention on the ability of mouse peritoneal macrophages to phagocytose chicken red blood cells, see Table 13. Table 13 Effect of the product of the present invention on the ability of mouse peritoneal macrophages to phagocytose chicken red blood cells (X Shi S) Group and dose The ability of mouse peritoneal macrophages to engulf chicken red blood cells

 /[g(kg ·weight animal number 1

 Phagocytosis rate 1 % phagocytic index

 Control group 10 23.1 ±4.8 0.35 ±0.05

 0.33 10 28.6±6.1 0.40 ±0.05

 0.67 10 27.8 ±5.6 0.40 ±0.05

 1.00 10 26.4 ±5.6 0.44 ±0.06*

Note: * indicates that compared with the control group, P < 0.05

 The phagocytosis rate of mouse peritoneal macrophages phagocytized chicken red blood cells was analyzed by variance, F=1.94, P>0.05. The phagocytic index was analyzed by square differential analysis, F = 3.16, P < 0.05 o Q test, and the 30-fold dose group compared with the control group, Ρ < 0.05, there was a significant difference.

2.6 The effect of the product of the invention on the activity of mouse sputum cells is shown in Table 14. Table 14 Effect of the product of the present invention on the activity of mouse sputum cells (X S)

Note: * indicates that compared with the control group, P < 0.05

After analysis of variance, F = 4.14. P < 0.05. Q test, 30 times the dose group compared with the control group, P <0.05, there was a significant difference. 3. Conclusion (1) The three dose groups of the present invention did not have a significant effect on animal body weight and body weight growth.

 (2) The thymus/body weight ratio of the 30-fold dose group recommended by the human body of the present invention was significantly different from that of the control group.

(3) The mouse cell immune function test showed that in the realization of spleen lymphocyte transformation, the 0D difference of the three dose groups recommended by the human body of the present invention was significantly higher than that of the control group, and the positive result was obtained; the delayed type allergic reaction experiment showed that Compared with the control group, the degree of ear swelling was significantly different between the 30-fold dose group and a positive result.

(4) The humoral immune function test of mice showed that in the antibody-producing cell experiment, compared with the control group, the number of hemolytic plaques in the spleen cells of the three dose groups of the present invention was significantly increased, and the positive result was obtained; assay showed that, HC ₅ 30 times dose group. The value was significantly different from the control group and showed a positive result.

 (5) The results of mouse monocyte-macrophage function test showed that the phagocytic index of the 30-fold dose group of the present invention was significantly higher than that of the control group in the mouse carbon clearance test; the mouse macrophage phagocytosis Chicken red blood cell test showed that the phagocytic index of the 30-fold dose group was significantly higher than that of the control group, showing a positive result.

 (6) The NK cell activity assay showed that the activity of NK cells in the 30-fold dose group of the present invention was significantly higher than that of the control group, and a positive result was obtained.

 According to the judgment standard of the "Technical Specification for Health Food Inspection and Evaluation" (2003) of the Ministry of Health, it is judged from the above results that the product of the present invention has an obvious function of enhancing immunity. Experimental Example 5: Test statistics showed that: 20 patients with diabetes were treated with the health food example 2 of the present invention, 52% obtained remarkable effects, 43% was basically effective, 4% was ineffective, and total efficiency was 4%. Up to 96%, and both indicate that after taking the health food of the present invention, the mental state is very good, and the immunity is greatly improved.

 The basic cure criteria: more than three symptoms disappeared, the test fasting blood glucose is normal, urine sugar is negative.

 Significant effect: (with two of the following three items) (1) The symptoms of the three symptoms basically disappeared; (2) The fasting blood glucose is basically normal; (3) The 24-hour urine sugar is negative or <5 g, and the urine sugar is negative.

 Effective: (with two of the following three items) (1) Fasting blood glucose decreased by more than 20%; (2) Three symptoms were significantly improved; (3) Urine sugar was reduced by more than 50%.

Invalid: Clinical symptoms are not improved, blood glucose is not obvious. Typical case 1: 隋XX, male, 50 years old, suffering from diabetes for 6 years. Fasting blood sugar 18.6, often chest tightness, insomnia, numbness in both feet, dry lips but do not like to drink water, urinating is not frequent, playing insulin <long-term effect> 30 units at noon, 28 units at night, blood sugar is not up to normal Later, after a friend introduced the effect of the health food, I just started taking the psychological test for a month, pancreas The island was reduced to 10 units at noon, and insulin was stopped at night. The blood sugar level dropped to normal. After three courses of treatment, the above symptoms disappeared.

 Typical case 2: Ding XX, female, 48 years old, suffering from diabetes for 5 years, then check the fasting blood glucose 12. 8mmol / L, two hours after the meal, blood glucose 19. 5mmol / L urine sugar (+ + +), weight loss from 130 kg To 100 kilograms, feeling boring, polydipsia, polydipsia, polyuria, polyphagia, and blurred vision, after taking metformin, mebida, sugar and equal hypoglycemic agents, blood sugar control is basically normal, because of fear of Western medicine Liver and kidney are damaged, there is always a psychological burden, I hope to take Chinese medicine treatment. In November 2009, I went to Beijing to go to the door. After a friend introduced the effect of the health food, I started taking it. After two boxes, I felt that my eyes were no longer blurred. I measured blood sugar 5. 9mmol/L. When I took the second course of treatment, blood sugar. Always staying in the normal range, the spirit is relaxed, can participate in various activities and the same as normal people, very happy, the weight increased from 100 kg to 110 kg, the recent review of glycated hemoglobin from the original 10.56% to 6. 75%, The blood pressure gradually returned to normal, and the mental state of the person also improved greatly.

Claims

Claim

 1. A product for enhancing immunity and controlling diabetes, comprising an active ingredient and an auxiliary material, the active ingredient consisting of the following components: 5-10 parts of Cordyceps militaris extract, 35-50 parts of Thousand Buddha extract 20-30 parts of lentinan, 5-10 parts of puerarin isoflavone, 7-15 parts of medlar extract, 8-20 parts of Coprinus comatus extract; wherein, Cordyceps militaris extract, Thousand Buddha extract, alfalfa extract and The extract of Coprinus comatus is extracted with water as a solvent and extracted by a conventional water extraction method of traditional Chinese medicine.

 2. The product for enhancing immunity and controlling diabetes according to claim 1, wherein the active ingredient is composed of the following components: 5-8 parts of Cordyceps militaris extract, 40-45 parts of Thousand Buddha extract, shiitake mushroom 25-30 parts of polysaccharide, 6-8 parts of puerarin isoflavone, 10-15 parts of medlar extract, and 10-18 parts of hamweed mushroom extract.

 3. The product for enhancing immunity and controlling diabetes according to claim 2, wherein the active ingredient is composed of the following components: 6 parts of Cordyceps militaris extract, 40 parts of Thousand Buddha extract, 25 parts of lentinan, 7 parts of Pueraria lobata, 10 parts of Lycium barbarum extract, and 12 parts of Coprinus comatus extract.

 A product for enhancing immunity of a living body and for controlling diabetes according to claim 1, wherein said auxiliary material contains a sweetener.

 The product for enhancing immunity of a living body and for controlling diabetes according to claim 4, wherein the sweetener is stevioside in an amount of 0.2 to 0.5 parts by weight.

 6. A product for enhancing immunity and controlling diabetes according to claim 1, wherein the product is in the form of a tablet, a capsule, a granule, an oral solution, or a beverage or a teabag.