CN112569292A

CN112569292A - Composition for regulating blood sugar and preparation method thereof

Info

Publication number: CN112569292A
Application number: CN202011601140.6A
Authority: CN
Inventors: 朱志铭; 金建文; 赵大鹏; 张赞; 李积珍
Original assignee: Hebei Yuzhilin Biotechnology Co ltd
Current assignee: Hebei Yuzhilin Biotechnology Co ltd
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2021-03-30

Abstract

The invention provides a composition for regulating blood sugar and a preparation method thereof, belonging to the technical field of blood sugar regulation. The composite material comprises the following raw materials in parts by weight: 400-600 parts of lycium barbarum bud, 320-480 parts of cyclocarya paliurus and 80-120 parts of moringa leaves. The composition provided by the invention can regulate blood sugar.

Description

Composition for regulating blood sugar and preparation method thereof

Technical Field

The invention belongs to the technical field of blood sugar regulation, and particularly relates to a composition for regulating blood sugar and a preparation method thereof.

Background

Firstly, blood sugar: glucose in the blood is called blood glucose (Glu), which is an important constituent of the human body and also an important source of energy. The normal human body needs a lot of sugar every day to provide energy, and provides power for the normal operation of various tissues and organs. Blood glucose must be maintained at a certain level to maintain the needs of the organs and tissues in the body. The production and utilization of normal human blood sugar are in dynamic equilibrium state, and are maintained at a relatively stable level.

Hyperglycemia, when the blood glucose level is higher than the normal range, is also one of the three generally known types of hyperglycemia, and the other two types of hyperglycemia are hypertension and hyperlipidemia, respectively. A normal fasting blood glucose level is 6.1mmol/L or less, a normal postprandial blood glucose level of two hours is 7.8mmol/L or less, and a level higher than this range is called hyperglycemia.

Under normal conditions, a human body can ensure the balance of the source and the route of blood sugar through two major regulating systems of hormone regulation and nerve regulation, so that the blood sugar is maintained at a certain level. However, under the combined action of genetic factors (such as family history of diabetes) and environmental factors (such as unreasonable diet, obesity and the like), the two major regulatory functions are disordered, and the blood sugar level is increased.

Second, the cause of hyperglycemia

1. Occasional hyperglycemia. If a large amount of sweet is eaten before blood sugar examination, a result of high blood sugar will certainly appear. Therefore, the blood glucose level is detected without worrying about it too much. After a certain time interval, the blood sugar result is checked again.

2. Bad living habits and environment. Most of the young people at present like Kendeji fast food, do not like vegetables and fruits, and the long eating habit may cause high blood sugar. The negative ions in the air are natural factors existing in the air and can effectively reduce hyperglycemia, but the content of negative oxygen ions in the air is greatly reduced due to environmental pollution, and the negative oxygen ions taken by a human body are insufficient, so that the negative ions are also an important reason for causing hyperglycemia.

3. Hyperglycemia due to other diseases. Coronary heart disease and the like are closely related to hyperglycemia. Therefore, once hyperglycemia is diagnosed, it should be clear as much as possible what cause is hyperglycemia, so that symptomatic treatment can be performed, and work for preventing and treating hyperglycemia can be well done.

4. After the above causes of hyperglycemia are excluded, then hyperglycemia is highly likely to be an early symptom of diabetes. The diabetic patient group is younger and younger at present, and even children diabetes mellitus appears. Therefore, it is necessary for diabetics to know that hyperglycemia is to be treated early.

5. Genetic factors may also cause hyperglycemia.

Diabetes mellitus

Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia due to multiple causes, and is caused by defects in insulin secretion and/or utilization. The long-term carbohydrate, fat and protein metabolism disorder can cause multi-system damage, and lead to chronic progressive lesion, hypofunction and failure of tissues and organs such as eyes, kidneys, nerves, hearts, blood vessels and the like. Acute severe metabolic disorders, such as diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome, can occur when the condition is severe or under stress.

Diagnostic criteria: according to the universal standard of the world, the fasting blood sugar is equal to or higher than 7.0mmol/L, or the blood sugar after two hours is equal to or higher than 11.1mmol/L, namely the diabetes diagnosis standard is achieved. An oral glucose tolerance test is carried out, and the blood sugar is equal to or higher than 11.1mmol/L two hours after the oral glucose tolerance test also reaches the diabetes diagnosis standard.

Disease classification: china currently adopts a WHO1999 etiology typing system to classify diabetes into the following four major categories:

1. type 1 diabetes mellitus

Most of the diseases are autoimmune diseases, and genetic factors and environmental factors are jointly involved in the pathogenesis of the diseases.

Genetic factors

The concordance rate of type 1 diabetes in the homozygote gemini reaches 30% -40%, and the genetic factor plays an important role in the onset of type 1 diabetes.

Environmental factors-

Viruses known to be involved in the onset of type 1 diabetes include rubella virus, mumps virus, coxsackie virus, encephalomyocarditis virus, cytomegalovirus, and enteroviruses have recently attracted attention.

③ autoimmunity

Humoral immunity: it has been found that 90% of newly diagnosed type 1 diabetes patients have a monoclonal antibody against beta cells in their serum, and more important antibodies include a polyclonal islet cell antibody, an insulin antibody, a glutamate decarboxylase antibody, a protein tyrosine phosphatase-like protein antibody, and the like. Two autoantibodies are positive, and the possibility of the occurrence of type 1 diabetes mellitus reaches 70 percent in the future, so the detection of the autoantibodies of the islet cells can predict the occurrence of type 1 diabetes mellitus, determine high risk groups, and assist in diabetes typing and guiding treatment.

Cellular immunity: cellular immune abnormalities play a more important role in the onset of type 1 diabetes. Cellular immune disorders are characterized by an imbalance in the proportion of pathogenic and protective T lymphocytes, and a disturbance in the interaction of their secreted cytokines or other mediators.

2. Type 2 diabetes mellitus

Type 2 diabetes is a polygenic hereditary complex disease caused by the combined action of genetic factors and environmental factors, and is a group of heterogeneous diseases.

Genetic and environmental factors

The concordance rate of type 2 diabetes in the same ovum twin is close to 100%, but the onset and progress of the disease are greatly changed under the influence of environmental factors. Environmental factors include age, modern lifestyle, excess nutrition, lack of physical activity, intrauterine environment and stress, chemical poisons, and the like. Obesity, particularly central obesity, caused by the combined action of genetic factors and the above environmental factors is closely related to the occurrence of insulin resistance and type 2 diabetes.

Insulin resistance and beta cell function deficiency

Defects in beta cell function, leading to varying degrees of insulin deficiency and insulin resistance in tissues, particularly skeletal muscle and liver, are two major components of the onset of type 2 diabetes.

Functional disorder of islet alpha cells and defective secretion of secretin

The number of islet beta cells of a type 2 diabetic patient is obviously reduced, and the proportion of alpha/beta cells is obviously increased. At the same time, the sensitivity of alpha cells to glucose is reduced, leading to increased glucagon secretion and increased hepatic glucose output.

Intestinal tract factor

The intestinal flora structure and function of a type 2 diabetes patient are different from those of a healthy person, and the intestinal flora can participate in the generation and development of type 2 diabetes through intervening the mechanisms of absorption and utilization of host nutrition and energy, influencing bile acid metabolism, promoting fat synthesis and storage, influencing chronic low-grade inflammatory reaction and the like.

3. Other specific types of diabetes

The etiology is relatively clear, such as some hyperglycemic states caused by pancreatitis, cushing's syndrome, glucocorticoid, cytomegalovirus infection, and the like.

4. Gestational diabetes mellitus

Diabetes or impaired glucose tolerance, which first occurs or is found during pregnancy, does not include patients who have been diagnosed with diabetes prior to pregnancy.

Fourth, diabetes treatment

1. And (3) drug treatment:

oral hypoglycemic agent

The following drugs can be used singly or in combination (two or three types), and can be used together with insulin, and the dosage of each preparation should be reduced when the drugs are combined. The appropriate choice of medication for each patient depends on the condition (hyperglycemia, fasting or postprandial hyperglycemia, islet function, liver and kidney function, complications, obesity and wasting), the characteristics of the medication, the patient's response to the medication, age, price, etc.

(II) metformin

The biguanide medicine can be used singly or combined with other medicines, currently, metformin hydrochloride is mainly used clinically, adverse reactions are usually mainly gastrointestinal reactions, such as appetite reduction, nausea, vomiting, diarrhea and the like, and the adverse reactions can be relieved by taking the biguanide medicine in a meal or after a meal or starting from a small dose. Alone causes little hypoglycemia and when used in combination with insulin or insulin secretagogues increases the risk of hypoglycemia. A rare serious adverse reaction is the induction of lactic acidosis.

③ sulfonylureas

Sulfonylureas (SUs) belong to the class of insulinotropic drugs, and the main pharmacological actions are to stimulate the pancreatic B cells to secrete insulin, increasing the insulin levels in the body. Sulfonylureas are suitable for type 2 diabetes in which a certain number of islet B cells (more than 30%) are still present, but are not suitable for type 1 diabetes, type 2 diabetes with acute or severe complications, pregnant women, lactating women, perioperative period of major surgery, childhood diabetes, postpancreatectomy, and allergy to sulfonylureas or severe adverse reactions. Sulfourea drugs, if improperly used, can cause hypoglycemia, particularly in elderly patients with liver and renal insufficiency, and can cause repeated hypoglycemia after drug withdrawal. Such agents include glyburide, gliclazide, and the like.

Alpha-glucosidase inhibitor

The action mechanism is to reversibly inhibit the small intestine alpha glycosidase, further prevent the saccharide from being decomposed into monosaccharide (mainly glucose), delay the absorption of the glucose and reduce the postprandial hyperglycemia. The traditional Chinese medicine composition is one of important oral medicines for treating diabetes at present, can be used alone or together with other hypoglycemic medicines, is mainly used for controlling postprandial hyperglycemia, and is used as an intervention medicine for abnormal glucose tolerance. The food should be taken after the first bite of food, and the dietary components should contain a certain amount of sugar. The herbs should be used with cautions for patients with liver and renal insufficiency because they are absorbed very slightly in the intestine, so they have no toxic adverse reaction. It is not suitable for patients with diabetic ketoacidosis, peptic ulcer or partial small intestinal obstruction and tendency of small intestinal obstruction, nor suitable for pregnant women, lactating women and children. The common drug is acarbose.

Penta thiazolidinedione drugs

Also known as glitazones, are diabetes mellitus. The medicine can be used alone or in combination with other hypoglycemic drugs for treating type 2 diabetes, especially patients with significant insulin resistance. The common adverse effects of thiazolidinediones are weight gain and edema, which do not cause hypoglycemia when used alone, but which increase the risk of hypoglycemia when used in combination with insulin or insulinotropic agents. Including rosiglitazone, pioglitazone, troglitazone, and the like.

Insulin and insulin analogs

The hypoglycemic health-care food comprises animals, human insulin and insulin analogues, and is suitable for people who are not controlled well by oral hypoglycemic drugs, people who have contraindications to oral hypoglycemic drugs, people who have poor islet function of type 1 diabetes and type 2 diabetes, people who have severe stress to type 2 diabetes (such as major operation, severe infection, myocardial infarction, cerebrovascular accident and the like), and people who have complications (vascular diseases or ketoacidosis, hypertonic syndrome, gestational diabetes and the like).

2. Surgical treatment

Metabolic surgery

Weight management is an important part of the overall management of diabetes, and weight loss in overweight or obese patients contributes to blood glucose control and reduces the need for hypoglycemic drugs. Lifestyle intervention is preferred, and weight-reducing drugs may be added if necessary. When selecting the hypoglycemic agent, the influence of the agent on body weight should be considered. If lifestyle intervention is combined or not combined with drug therapy, and the patient fails to effectively lose weight and has poor blood sugar control, metabolic surgery can be considered, and the metabolic surgery can obviously improve the weight, hyperglycemia and dyslipidemia of the obese type 2 diabetic patient.

3. Nutritional treatment

Firstly, nutrition treatment

Nutritional therapy is the basis of all diabetes treatments, is an essential measure for preventing and controlling diabetes at any stage in the natural course of diabetes, and is also the main treatment measure for elderly, obese and light patients with few symptoms. The general principle is to determine a reasonable total energy intake, distribute various nutrients reasonably and evenly, and recover and maintain an ideal body weight.

② reasonably controlling total heat quantity

The weight of the patient is lower than the ideal weight, children, pregnant women, lactating women and patients with consumptive diseases, the energy intake can be properly increased by 10-20%, and the obese patient can be reduced, so that the weight is gradually recovered to about +/-5% of the ideal weight. The total energy of the patient per day is determined by age, height, weight and labor intensity. The ideal body weight is estimated by the formula of ideal body weight (kg) to height (cm) -105.

Distribution of nutrients

The supply amount of the carbohydrate in the diet is 50-60% of the total calorie, the daily staple food intake of an adult patient is 250-400 g, and the obesity patient can be controlled within 200-250 g according to the condition.

The protein intake accounts for 15-20% of the total heat, and the ideal weight of an adult patient per kilogram per day is 0.8-1.2 g; pregnant women, women returning to lactation, malnutrition or patients with consumptive diseases increase to 1.5-2.0 g; the amount of the medicine is limited to 0.8g for patients with diabetic nephropathy and normal renal function; for the decrease of glomerular filtration rate, it should be decreased to 06-0.7 g.

The daily fat intake accounts for 25-30% of the total calorie, wherein the saturated fatty acid intake is less than 10% of the total energy, and the cholesterol intake is less than 300 mg/d.

The intake of the adult dietary fiber is 25-30 g/d. The daily intake of salt should be limited to 6g or less.

Limit for smoking cessation.

Fourthly, reasonable meal distribution

After the total heat of diet and the composition proportion of carbohydrate, protein and fat are determined every day, a diet is prepared according to the heat production of 4kcal per gram of carbohydrate and protein and 9kcal per gram of fat after the heat is converted into food, and the diet is arranged according to the living habits, the illness conditions and the treatment needs of matched medicines of individuals.

4. Other treatments

Exercise therapy

The body should be exercised every 30 minutes for a long time, and it is recommended to keep exercising with moderate intensity for 150 minutes every week, and to monitor blood sugar before and after exercising. In order to avoid excessive blood sugar fluctuation, type 2 diabetics should be exercised after meals. The blood sugar is more than 1-16 mmol/L, the recent frequent hypoglycemia or large blood sugar fluctuation, and people with acute complications of diabetes and chronic complications such as severe center of gravity, brain, eyes, kidney and the like are temporarily not suitable for exercise.

Fifthly, diabetes: hyperglycemia, which is considered by traditional Chinese medicine, is diabetes, which is a comprehensive symptom mainly characterized by polydipsia, diuresis, polyphagia, emaciation, fatigue and urine sweetness. If the test is performed, the main characteristics are hyperglycemia and urine glucose. In the medical history of the world, TCM has the earliest knowledge and is discussed in detail. Diabetes in traditional Chinese medicine is known as diabetes in Huangdi's classic on internal medicine strange diseases. Diabetes, lung heat damaging fluid and thirst with polydipsia as the upper part of the traditional Chinese medicine; the stomach-fire is stir-baked to exuberance, and the food is fully allayed by hunger; kidneys do not control water and frequent urination is descending and dispersing. The syndrome of diabetes can not be caused by lung dryness, stomach heat and kidney deficiency complicated with or with side weight. The "Nei Jing" also has the records of the names of diabetes, diaphragmatic consumption, pulmonic consumption and diabetes, and the "Nei Jing" considers that the weakness of five zang organs, overeating fatness and sweetness and emotional disorder are the causes of diabetes, and internal heat is the main pathogenesis of the disease. For the first time, the therapeutic prescription was proposed as discussed in the book of the golden Kui Yao L ü e. The "theory of etiology of various diseases and diabetes" discusses the complications: its pathological changes are often carbuncle and deep rooted carbuncle. Diabetes mainly occurs in lung, stomach and kidney, and its basic pathogenesis is yin and body fluid consumption and predominant dry heat. After long-term thirst, the disease is out of control, yin deficiency involving yang, heat scorching fluid and blood stasis, which lead to qi and yin deficiency, yin-yang deficiency, collateral channel stasis, channel malnutrition, qi and blood disorder, viscera organ damage, and furuncle, carbuncle, vertigo, thoracic obstruction, deafness, blindness, limb numbness and pain, lower limb gangrene, renal failure, edema, apoplexy, coma and other complications.

Classification and treatment of diabetes

1. The diabetes can be divided into three types of diabetes, namely upper, middle and lower diabetes, and the specific type and treatment mode are as follows:

(1) upper-jiao (lung-heat-dispersing): thirst and polydipsia are the main symptoms. It is used to clear heat, moisten lung, promote the production of body fluid and quench thirst. The method comprises the following steps: diabetes prescription, Erdong decoction, Yuquan powder, etc.

(2) Middle warmer (stomach-qi-dispersing): the symptoms of polyphagia and bulimia are mainly caused. The method of clearing stomach-fire, nourishing yin and increasing fluid is used. The method comprises the following steps: baihu Tang, Yunv Jian, Shengmai san.

(3) Xiao (shenxiao): it is mainly manifested as polydipsia, diuresis, and drinking with urine. For kidney yin deficiency, Liuwei Dihuang Wan is often used; for kidney yang deficiency, jin Kui Shen Qi Wan is often used.

2. The treatment is carried out according to the types of the abundance or the decline of yin and yang:

(1) yin deficiency type: liuwei Dihuang Wan, Shengmai san Beiyuan Zengye Tang, Buyuan Jian.

(2) Type of yin deficiency with yang hyperactivity: diabetes prescription, Yunv Jian, Zhibai Dihuang Wan.

(3) Yang deficiency (qi deficiency) type: jin Kui Shen Qi Wan, Yougui Yin, Yougui Wan.

(4) Type of deficiency of both yin and yang (deficiency of both qi and yin): jin Kui Shen Qi Wan (pill of replenishing Kidney Qi).

3. According to the yin-yang classification of viscera and the treatment

(1) Stomach heat injury type: clearing stomach fire, nourishing stomach yin, and giving consideration to kidney yin method: baihu Tang, Yunv Jian or Baihu plus Huanglian Zuo Dihuang preparation.

(2) Stomach and lung heat damaging the female type: purging stomach fire, clearing lung heat, nourishing kidney yin, tonifying spleen and earth: the white tiger is added with a coptis root, a zoysia preparation, and is added with codonopsis pilosula and astragalus.

(3) Stomach-lung heat damaging yin and kidney deficiency: nourishing yin, clearing heat, invigorating qi and tonifying kidney.

(4) Kidney yin deficiency type: pill of six ingredients with rehmannia.

(5) Type of yin deficiency of lung and kidney: yin-nourishing and heat-clearing method: modified Yuquan san combined Shengmai san.

(6) Kidney yang deficiency type: modified jin Kui Shen Qi Wan or Lu Rong Wan.

Although the prior art also has medicines for regulating blood sugar, the prior art either adopts chemical medicines to quickly reduce blood sugar, and has a plurality of side effects, or adopts traditional Chinese medicines to control blood sugar for a long time, and has no formula for controlling blood sugar change for 2 months and controlling blood sugar index change after meal to be too quick, and particularly has no report about no combination of fruit wolfberry buds, cyclocarya paliurus and moringa leaves to simultaneously regulate long-term and short-term blood sugar indexes.

Disclosure of Invention

In view of the above, the present invention provides a composition for regulating blood sugar and a preparation method thereof, and the composition provided by the present invention can regulate blood sugar.

In order to achieve the above purpose, the invention provides the following technical scheme:

the invention provides a composition for regulating blood sugar, which comprises the following raw materials in parts by weight:

400-600 parts of lycium barbarum bud, 320-480 parts of cyclocarya paliurus and 80-120 parts of moringa leaves.

Preferably, the feed comprises the following raw materials in parts by weight:

500 parts of medlar buds, 400 parts of cyclocarya paliurus and 100 parts of moringa leaves.

Preferably, the particle size of the composition is 10-14 meshes.

The invention also provides a preparation method of the composition in the technical scheme, which comprises the following steps: mixing the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves with water to obtain a mixture, extracting the mixture at 90-100 ℃ for 3 times, combining the extracting solutions, and preparing into particles to obtain the traditional Chinese medicine composition.

Preferably, in the first extraction, the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water is 0.5-1.5 g: 10-14 mL.

Preferably, in the second extraction, the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water is 0.5-1.5 g: 8-12 mL.

Preferably, in the third extraction, the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water is 0.5-1.5 g: 6-10 mL.

The invention also provides a preparation method of the composition in the technical scheme, which comprises the following steps: mixing the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves with an ethanol solution, performing ethanol extraction for 3 times at 70-85 ℃, combining the ethanol extraction solutions, and preparing into granules to obtain the composition.

Preferably, the time of the first alcohol extraction is 1.5-2.5 h, the time of the second alcohol extraction is 1-2 h, and the time of the third alcohol extraction is 1-2 h.

Preferably, the ethanol solution is 45-55% by volume.

The invention provides a composition for regulating blood sugar, which comprises the following raw materials in parts by weight: 400-600 parts of lycium barbarum bud, 320-480 parts of cyclocarya paliurus and 80-120 parts of moringa leaves.

The formula has the advantages that:

li Shizhen (compendium of materia Medica) calls that the bud of Chinese wolfberry is Tianjing grass, bitter, sweet and cool in nature and enters the four meridians of heart, lung, spleen and kidney; it is considered as tough and tough, resistant to aging, capable of dispelling wind, tonifying bones and muscles, and benefiting people to relieve fatigue from the dietetic herbal medicine. The medlar-free bud is a new tree species cultivated by grafting a wild medlar branch and a Ningxia medlar branch, the medlar-free bud does not bloom and bear fruits, most of nutrient components are accumulated in tender buds, the tea and medlar are integrated, catechin is polyphenol which accounts for the highest proportion in the medlar-free bud, catechin red EGCG and ECG have obvious inhibition effect on angiotensin I converting enzyme, and the components can adjust the percentage of glycosylated hemoglobin, reduce LDL cholesterol and stabilize blood pressure.

The cyclocarya paliurus tea has the effects of clearing heat, quenching thirst and detoxifying, is rich in organic nutritional ingredients such as saponin, flavone and polysaccharide, and can effectively balance glycometabolism of a human body, so that the health-care effects of reducing blood sugar and reversing complications are achieved; the cyclocarya paliurus also contains a large amount of inorganic nutritional ingredients such as iron, zinc, selenium, chromium, germanium, magnesium, calcium and the like, contains trace elements such as manganese, iron, copper, chromium, zinc, selenium, vanadium, germanium and the like, has high content of elements such as Ni, Cr, V and Se closely related to glycometabolism and insulin action, can assist insulin to play a role in reducing blood sugar and can improve sugar tolerance.

The moringa leaves are pure natural green food, and the moringa leaves and the fruit pods are rich in various minerals, vitamins, 20 amino acids, 46 antioxidants and 36 natural anti-inflammatory substances and minerals. Every 100g of moringa oleifera contains 7 times of vitamin C, 3 times of iron, 4 times of carrot, 4 times of calcium, 3 times of potassium and 2 times of protein. It can replace compound vitamin, calcium tablet, cod liver oil, etc. Especially has good effects on hypertension, hyperlipemia, diabetes, gout and the like.

In conclusion, the composition provided by the invention takes the medlar buds as the monarch drug to control the blood sugar for a long time. Cyclocarya paliurus is used as a ministerial drug, promotes the insulin to take effect quickly, and solves the problem of short-term blood sugar. The moringa leaves are used as a messenger drug, and the metabolism of human body protein, fat and carbohydrate is regulated, so that the long-term effect of the medlar bud-free tea and the short-term effect of cyclocarya paliurus play a synergistic role, and the effect of 1+1+1 > 3 is achieved.

Detailed Description

The composition provided by the invention comprises 400-600 parts by weight of medlar buds without fruits, and preferably 500 parts by weight of medlar buds without fruits. In the present invention, the lycium barbarum-free sprouts contain a large amount of specific polyphenol components, and regulate glycated hemoglobin, which is an index of long-term change in blood glucose, to control long-term change in blood glucose.

The composition provided by the invention comprises 320-480 parts by weight of cyclocarya paliurus, and preferably 400 parts by weight of cyclocarya paliurus. In the invention, the cyclocarya paliurus contains trace elements of Ni, Cr, V and Se, can rapidly promote the effect of insulin, and solves the change of short-term blood sugar.

The composition provided by the invention comprises 80-120 parts by weight of moringa leaves, and preferably 100 parts by weight of moringa leaves. In the invention, the moringa leaves contain abundant vitamins, calcium and protein, comprehensively supplement protein, vitamins and the like, and supplement and regulate the pathological state of metabolic disorder of substances such as protein, fat, carbohydrate and the like in a human body in metabolic syndrome.

In the present invention, the particle size of the composition is preferably 10 to 14 mesh.

In the present invention, the method of using the composition preferably comprises: the composition is brewed and drunk as tea, and 4-6 g of the composition is brewed each time. The composition is not particularly limited in the number of times of use per day, and can be drunk after being brewed with tea.

In the invention, when the first extraction is carried out, the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water is preferably 0.5-1.5 g: 10-14 mL, and more preferably 1g:12 mL; when the second extraction is carried out, the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water is preferably 0.5-1.5 g/8-12 mL, and more preferably 1 g/10 mL; when the extraction is carried out for the third time, the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water is preferably 0.5-1.5 g/6-10 mL, and more preferably 1 g/8 mL.

In the invention, the time for the first alcohol extraction is preferably 1.5-2.5 h, and more preferably 2 h; the time for the second alcohol extraction is preferably 1-2 h, and more preferably 1.5 h; the time for the third alcohol extraction is preferably 1-2 h, and more preferably 1.5 h. In the invention, the volume percentage content of the ethanol solution is preferably 45-55%.

The technical solutions provided by the present invention are described in detail below with reference to examples, but they should not be construed as limiting the scope of the present invention.

Example 1

The composition for regulating blood sugar is prepared from 500g of fruitless Chinese wolfberry bud, 400g of cyclocarya paliurus and 100g of moringa leaves.

The preparation method comprises the following steps: mixing fructus Lycii bud, cyclocarya paliurus, and Moringa oleifera leaf with water to obtain a mixture, extracting the mixture at 100 deg.C for 3 times, mixing extractive solutions, and granulating to obtain Chinese medicinal composition, wherein the first time is 12 times of the total weight of the raw materials, the second time is 10 times of the total weight of the raw materials, and the third time is 8 times of the total weight of the raw materials. The particle size of the traditional Chinese medicine composition is 10 meshes.

Example 2

The composition for regulating blood sugar is prepared from 400g of fruitless Chinese wolfberry bud, 320g of cyclocarya paliurus and 80g of moringa leaves.

The preparation method comprises the following steps: mixing fructus Lycii bud, cyclocarya paliurus, and Moringa oleifera leaf with water to obtain a mixture, extracting the mixture at 90 deg.C for 3 times, mixing extractive solutions, and granulating to obtain Chinese medicinal composition, wherein the first time is 12 times of the total weight of the additive materials, the second time is 10 times of the total weight of the additive materials, and the third time is 8 times of the total weight of the additive materials. The particle size of the traditional Chinese medicine composition is 10 meshes.

Example 3

The composition for regulating blood sugar is prepared from 600g of fruitless Chinese wolfberry buds, 480g of cyclocarya paliurus and 120g of moringa leaves.

Example 4

The preparation method comprises the following steps: mixing fructus Lycii bud, cyclocarya paliurus, and Moringa oleifera leaf with ethanol solution, extracting with ethanol at 80 deg.C for 3 times, mixing the extractive solutions, and granulating to obtain the composition. The time of the first alcohol extraction is 2 hours, the time of the second alcohol extraction is 1.5 hours, and the time of the third alcohol extraction is 1.5 hours. The particle size of the traditional Chinese medicine composition is 10 meshes.

Example 5

The preparation method comprises the following steps: mixing fructus Lycii bud, cyclocarya paliurus, and Moringa oleifera leaf with ethanol solution, extracting with ethanol at 75 deg.C for 3 times, mixing the extractive solutions, and granulating to obtain the composition. The time of the first alcohol extraction is 2.5h, the time of the second alcohol extraction is 2h, and the time of the third alcohol extraction is 2 h. The particle size of the traditional Chinese medicine composition is 12 meshes.

Example 6

The preparation method comprises the following steps: mixing fructus Lycii bud, cyclocarya paliurus, and Moringa oleifera leaf with ethanol solution, extracting with ethanol at 85 deg.C for 3 times, mixing the extractive solutions, and granulating to obtain the composition. The time of the first alcohol extraction is 2.5h, the time of the second alcohol extraction is 2h, and the time of the third alcohol extraction is 2 h. The particle size of the traditional Chinese medicine composition is 14 meshes.

Example 7

Formulation screening of compositions of the invention

Experiment raw materials: 200 parts, 400 parts and 600 parts of medlar-free buds respectively; 160 parts, 320 parts and 480 parts of cyclocarya paliurus; the moringa leaves are 40 parts, 80 parts and 120 parts respectively.

Subject: 50 patients with type 2 diabetes.

One, one component exploration process

The composition formulation screening process the single component search process is shown in the following table:

table 1 composition formulation screening experiments single component search procedure

The experimental result shows that when the medlar buds are not available, the effect is more ideal after taking 400 parts and 600 parts of the medlar buds alone for 30 days, and the effect is not obvious after taking 200 parts of medlar buds; when the cyclocarya paliurus is taken alone, 320 parts and 480 parts of cyclocarya paliurus are taken, the effect is not obvious when 160 parts of cyclocarya paliurus are taken, the effect is obvious after 7 days of taking, the effect is quick, the effective rate is stable along with the increase of the taking time, and the effective rate is in a descending trend after 30 days of taking; when the moringa leaves are taken alone, the effect of reducing the blood sugar by each dosage is not ideal.

Two, two raw materials combined experimental results

Grouping experiments: firstly, no fruit and Chinese wolfberry bud is multiplied by cyclocarya paliurus

② no fructus lycii bud and moringa leaves

③ cyclocarya paliurus and moringa oleifera leaves

The specific experimental typing and experimental results are shown in the following table:

TABLE 2 two-component compatibility experiment schedule

Table 3 statistical table of results of two-component compatibility experiments (effective rate,%)

The experimental result shows that the effect of reducing blood sugar can be quickly exerted without compatibility of the medlar buds and the cyclocarya paliurus, the effect is durable, the application of the moringa leaves can play a role in stabilizing the effect to a certain extent, in conclusion, the effect of the compatibility of the two components is superior to that of single component application, the blood sugar can be regulated in two aspects of short term and long term, and the effect is durable.

Three, three raw material combination orthogonal test analysis

To further explore the optimal combination of the compositions, an orthogonal test of the 3-component compatibility was performed.

The experimental method comprises the following steps: orthogonal tests are carried out on 3 raw materials in proportion, related indexes are detected before the tests, the detection and the comparison are carried out again after the raw materials are taken for 1 month, the test results are analyzed after the detection is finished, and an experiment schedule and an intuitive analysis table are shown as follows:

TABLE 4 composition formulation screening Experimental schedules

TABLE 5 visual analysis chart for composition formula screening

The experimental results are as follows: the experimental result shows that the number of the medlar buds has obvious influence on the experimental result, and when the number of the medlar buds is 400 parts and 600 parts, the experimental result is obviously superior to 200 parts; when the amount of the cyclocarya paliurus is 320 parts and 480 parts, the result is obviously better than 160 parts; the experimental results of 80 parts and 120 parts of moringa leaves are not very different, but are better than the experimental results of 40 parts of moringa leaves.

Example 8

Summary of clinical trials for the regulation of blood glucose by the composition of the invention

Object and method

1. Subject: 50 patients with type 2 diabetes mellitus are between 45 and 65 years old, 23 men and 27 women have no diabetes-related complications or other serious diseases, and have no serious dysfunction of important organs.

2. The test substance: formulation of example 6

3. Control format: 50 diabetic patients were randomly and equally divided into control group and test group

4. Dosage and time of administration: the test group takes the composition 1 bag daily and 2 times daily, and the control group takes metformin tablet 2 tablets each time and 2 times daily.

Second, focus on observing the index

Fasting plasma glucose, glycated hemoglobin and postprandial 2h plasma glucose.

Third, observe the results

Patient blood glucose changes before and after intervention are as follows:

TABLE 6 blood glucose Change of patients before and after intervention

P is less than or equal to 0.05, the difference before and after the test feeding is obvious, and the experimental result has statistical significance.

Four, small knot

The human body trial experiment proves that the blood sugar regulating capsule has obvious difference before and after trial eating and has the function of regulating blood sugar.

Example 9

Pharmacological experiment of the composition for regulating blood sugar

Object and method

1. Experimental animals: 100 SPF-level healthy mice bred by Beijing Huafukang biotech GmbH (production license number: SCXK (Jing) 2009-.

2. Molding: feeding with adaptive common feed for one week, randomly taking 20 as blank control group, feeding with common feed, feeding 80 as model group, feeding with high-sugar and high-fat feed, and simultaneously performing small amount of multiple intraperitoneal injections of STZ to induce diabetes model. The rats successfully molded were divided into a model control group, a low dose administration group, a medium dose administration group, and a high dose administration group.

3. The test substance: formulation of example 6

4. Dose selection

The recommended amount of the sample for human body is 6.0g/60kg. bw, and the experiment is designed into three dose groups, namely: 0.51 g/kg.bw, 0.99g/kg.bw and 3.00g/kg.bw, and the dosages of the low, medium and high groups are respectively equal to 5 times, 10 times and 20 times of the recommended dosage of a human body.

5. Method of administration

The administration group is intragastrically administered for 2 times daily according to the set dose, and the blank control group and the model group are intragastrically administered with the same volume of normal saline.

Second, focus on observing the index

Fasting blood sugar

Oral glucose tolerance

Serum insulin

Glycated hemoglobin

Serum Triglyceride (TG)

Cholesterol (TC)

Third, Experimental methods

1. Determination of oral glucose tolerance

All mice are subjected to fasting treatment without water prohibition for 12 hours, and fasting blood glucose value, namely blood glucose value of 0 hour, is measured after fasting is finished. The corresponding test sample is filled into the stomach of the experimental group mouse according to the body weight, the blank group mouse and the model group mouse are filled with the same volume of physiological saline for replacement, the stomach is filled with glucose (2.5g/kg) after 15-20min, then the blood sugar value of each rat is measured after 0, 0.5 and 2h of glucose administration, and the change of the area under the blood sugar curve at different time points after each group is filled with the glucose is observed.

Area under blood glucose curve is 0.25 × (fasting blood glucose +4 × 0.5h blood glucose +3 × 2h blood glucose)

2. Determination of serum insulin and glycated protein levels

Blood is collected at the end of the experiment, and the content of serum insulin and glycosylated hemoglobin is measured.

3. Determination of serum TG, TC content

Two days before the measurement of the serum TG and TC contents, the mice fed with the high-fat feed are stopped, after the mice are fed with the common feed for two days, the mice of each group are fasted without water supply for 12 hours, and the serum TG and TC contents of the mice are detected after the treatment is finished.

Fourth, experimental results

1. Measurement of oral glucose tolerance

TABLE 7 Effect of compositions on oral glucose tolerance in diabetic mice: (

mmol/L)

Group of	Before molding	After molding
			Blank control group	18.96±3.02	17.56±1.27
Model set	19.52±2.98	29.43±5.48
			Low dose group	19.24±3.11	23.23±3.25
Middle dose group	19.87±2.36	23.19±2.87
			High dose group	20.15±2.87	21.55±3.37

As shown in the table above, AUC of each group before modeling has no significant difference, and AUC values of the model group are significantly increased compared with those of the blank group after modeling, which indicates that the diabetes model is successfully modeled; compared with the model group, the AUC of the administration group is obviously reduced, which indicates that the composition has the condition of reducing the impaired oral glucose tolerance of diabetic mice.

2. Determination of serum insulin and glycated protein levels

TABLE 8 Effect of compositions on mouse serum insulin and glycated protein levels

Group of	Insulin (mU/L)	Glycated hemoglobin (%)
			Blank control group	42.86±3.12	4.93±0.53
Model set	21.38±2.54	9.68±0.47
			Low dose group	35.47±2.72	6.34±0.31
Middle dose group	36.52±2.14	5.78±0.41
			High dose group	37.15±3.07	5.65±0.32

Compared with a blank control group, the serum insulin level of the model group is obviously reduced (P is less than 0.01), and the content of the glycosylated hemoglobin is obviously increased (P is less than 0.01); compared with the model group, the serum insulin level of the administration group is obviously increased (P is less than 0.05), the content of the glycosylated hemoglobin is obviously reduced (P is less than 0.05)

3. Determination of serum TG, TC content

TABLE 9 change in serum TG and TC content in mice

Compared with a blank control group, the TG content level of the model group is obviously reduced (P is less than 0.01), and the TC content is obviously increased (P is less than 0.01); compared with the model group, the TG content level of each group is obviously increased (P is less than 0.05) and the TC content is obviously reduced (P is less than 0.05)

4. Small knot

The experimental result shows that the low, medium and high dosage of the composition can reduce the condition of impaired oral glucose tolerance of diabetic mice; increasing the level of serum insulin and reducing the content of glycosylated hemoglobin; increasing TG content, reducing TC content, improving diabetes related index, and reducing blood sugar level of diabetic mouse.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims

1. The composition for regulating blood sugar is characterized by comprising the following raw materials in parts by weight:

2. The composition according to claim 1, characterized by comprising the following raw materials in parts by weight:

3. The composition according to claim 1 or 2, wherein the particle size of the composition is 10 to 14 mesh.

4. A method of preparing a composition as claimed in any one of claims 1 to 3, comprising: mixing the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves with water to obtain a mixture, extracting the mixture at 90-100 ℃ for 3 times, combining the extracting solutions, and preparing into particles to obtain the traditional Chinese medicine composition.

5. The preparation method of claim 4, wherein the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water in the first extraction is 0.5-1.5 g: 10-14 mL.

6. The preparation method of claim 4, wherein the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water in the second extraction is 0.5-1.5 g: 8-12 mL.

7. The preparation method of claim 4, wherein the volume ratio of the total mass of the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves to water in the third extraction is 0.5-1.5 g: 6-10 mL.

8. A method of preparing a composition as claimed in any one of claims 1 to 3, comprising: mixing the lycium barbarum bud, the cyclocarya paliurus and the moringa oleifera leaves with an ethanol solution, performing ethanol extraction for 3 times at 70-85 ℃, combining the ethanol extraction solutions, and preparing into granules to obtain the composition.

9. The preparation method of claim 8, wherein the time for the first alcohol extraction is 1.5-2.5 h, the time for the second alcohol extraction is 1-2 h, and the time for the third alcohol extraction is 1-2 h.

10. The method according to claim 8, wherein the ethanol solution is 45 to 55% by volume.