Traditional Chinese medicine composition for treating insulin resistance of diabetes and preparation method thereof

Abstract

The invention belongs to the technical field of diabetes medicines, and particularly relates to a traditional Chinese medicine composition for treating diabetic insulin resistance and a preparation method thereof, the composition comprises the following main components by weight: 20-40 parts of Radix Astragali, 15-25 parts of Radix Puerariae, 12-18 parts of fried Rhizoma Atractylodis Macrocephalae, 20-40 parts of mulberry twig, 9-15 parts of Salvia miltiorrhiza, 15-25 parts of Radix Trichosanthis, 20-40 parts of Chinese yam, 12-18 parts of white hyacinth bean and 9-15 parts of Fructus Amomi. , 9-15 parts of gordon euryale seed and 9-15 parts of silkworm excrement. According to the traditional Chinese medicine composition, medicines for invigorating the spleen and replenishing qi are matched with medicines for clearing away heat and eliminating dampness, yin tonifying and yang raising are simultaneously used, yin and yang of the spleen are mutually generated, dampness eliminating and heat clearing are simultaneously used, dampness and heat evil are removed, the effects of invigorating the spleen, clearing heat and eliminating dampness are jointly achieved, and the curative effects of improving diabetes insulin resistance symptoms and signs, improving the life quality of patients and the like are remarkable.

Description

Technical Field

[0001] The invention belongs to the technical field of diabetes medicines, and particularly relates to a traditional Chinese medicine composition for treating diabetic insulin resistance and a preparation method thereof. Background Art

[0002] Diabetes is a progressive metabolic disease characterized by persistent hyperglycemia. The current pathogenesis of diabetes mainly includes insufficient insulin secretion, insulin resistance, increased secretion of pancreatic glucose-raising hormone, insufficient muscle glucose uptake, decreased liver glycogenolysis and synthesis, weakened incretin action, increased renal tubular glucose reabsorption, and weakened feeding control center. Among them, insufficient insulin secretion means that the amount of insulin secreted in the body cannot meet the needs of sugar metabolism. It may be caused by a variety of reasons, including pancreatic β-cell dysfunction, pancreatic cell damage, autoimmunity, endocrine disorders, relative insulin deficiency, etc. It is the main pathogenesis of type 1 diabetes. Insulin resistance (IR) refers to the reduced metabolic response of insulin to target organs and tissues, or the reduced or impaired response of blood sugar levels to insulin. Insulin regulates the body's glucose uptake. Disorders in insulin signal transduction can cause cells to be unable to uptake glucose, thereby causing hyperglycemia. It is the main pathogenesis of type 2 diabetes mellitus (T2DM), which appears in the early stages of T2DM and leads to metabolic abnormalities in T2DM patients. It runs through the entire course of T2DM and drives the occurrence and development of T2DM. Epidemiological surveys show that T2DM is the main type of diabetes in Chinese adults, and IR is the most common, with a prevalence of 12.8%.

[0003] At present, the main drugs used to treat insulin resistance in diabetes include biguanides, thiazolidinediones, α-glucosidase inhibitors, etc., which reduce IR and improve the function of pancreatic β cells by increasing tissue sensitivity to insulin, increasing the number of insulin receptors, regulating intestinal flora, etc. However, as the disease progresses and dependence on exogenous drugs gradually increases, complications such as renal insufficiency are prone to occur, and adverse reactions are obvious.

[0004] As traditional Chinese medicine is becoming more and more prosperous, a large number of studies have confirmed that traditional Chinese medicine plays an unparalleled advantage in the treatment of insulin resistance in diabetes. Studies have shown that under normal serum insulin levels, target organs of IR patients cannot perform normal synergistic hypoglycemic responses, including the uptake and utilization of glucose, the synthesis of liver glycogen and muscle glycogen, the inhibition of fat decomposition and the inhibition of endogenous glucose production. Traditional Chinese medicine can reduce the activity of acetyl-CoA and phosphatidylcholine in liver mitochondria, inhibit gluconeogenesis and glycogenolysis, and promote glycolysis to improve IR; it can also increase the expression level of proteins related to the insulin signaling pathway, enhance the sensitivity of insulin receptors, improve glucose uptake efficiency, improve IR, and thus reduce blood sugar levels. Traditional Chinese medicine treatment can not only reduce the adverse reactions of Western medicine, but also reduce the occurrence of diabetic complications or delay their development.

[0005] Therefore, exploring effective Chinese herbal medicine compositions to prevent and treat insulin resistance in diabetes has become a difficult problem for Chinese medicine practitioners in my country and is also the direction of research. Summary of the invention

[0006] In view of the current situation that there is still a lack of unified and effective treatment plans for the prevention and treatment of diabetes insulin resistance by traditional Chinese medicine, the present invention provides a traditional Chinese medicine composition for treating diabetes insulin resistance and a preparation method thereof. The composition is composed of drugs such as astragalus, kudzu root, stir-fried atractylodes, mulberry branch, salvia miltiorrhiza, root of trichosanthes, yam, white hyacinth bean, amomum villosum, Euryale ferox, silkworm feces, etc., and is matched with spleen-strengthening and qi-invigorating drugs and heat-clearing and dampness-removing drugs, and yin-tonifying and yang-raising drugs are used together to promote the mutual generation of spleen yin and yang, and dampness-drying and heat-clearing drugs are used together to remove dampness and heat evil, thereby playing the role of strengthening the spleen, clearing heat and removing dampness, and having significant therapeutic effects on improving symptoms and signs of diabetes insulin resistance and improving the quality of life of patients.

[0007] There is no record of insulin resistance in diabetes in ancient Chinese medical books. Modern doctors classify it as "Xiao Ke", "Xiao Gan" and "Pi Gan". Regarding the occurrence of this disease, it is generally believed to be related to excessive diet, improper work and rest, etc. "Ancient and Modern Medical Complete Works·Xiao Ke Chapter" says: "Although there are several different types of diabetes, the origin of the disease is all caused by excessive consumption of fat and sweet food, excessive alcohol, sex and fatigue. It is a disease of the rich and noble, but rarely seen in the poor and humble." If the five flavors are balanced, the diet is proper, and the daily life is regular, the yin and yang in the body are balanced. If there are excessive food preferences and excessive work and rest, the internal organs will not be harmonized and it is easy to develop into disease. "Shengji Zonglu·Xiao Ke Chapter" mentions: "...Xiao Gan is a disease caused by excessive consumption of fat and sweet food, and excessive accumulation of fat and sweet food is spleen Gan. Once the Gan disease is formed, it is Xiao Zhong. They are all caused by single yang without yin, and the evil heat is dominant..." Fatty and sweet foods are heavy and greasy, and alcohol is hot and damp. Overeating and drinking can easily damage the spleen and stomach, block the body's clear yang, and cause the essence of food and water to accumulate dampness and heat inside the body, which over time will turn into heat and dryness, burning the yin fluids and eventually causing diabetes.

[0008] The spleen and stomach are the foundation of the acquired constitution. If the foundation is damaged, all kinds of diseases will arise. "Lingshu Benzang" proposed that "the spleen is fragile and prone to diseases and thirst", and believed that spleen deficiency is the main pathogenesis of thirst. Patients usually like to eat spicy and fatty foods, prefer to drink alcohol, and are too idle and less active, which causes the spleen to lose its healthy function, resulting in the internal generation of phlegm and dampness, which will turn into heat over time and produce dampness and heat. Therefore, the main location of diabetes insulin resistance is the spleen, and the pathogenesis should be spleen deficiency as the root and dampness and heat as the symptoms. Diabetes insulin resistance is mainly manifested by metabolic disorders of fine substances such as glycolipids and proteins. The spleen is responsible for transporting and transforming the essence of water and grain. If the spleen fails to transport and transform, the clear qi will not rise, and the essence and qi will be injected downward, forming thirst. Dampness is a yin evil, which can easily damage yang qi. It is heavy and turbid in nature, stagnating between the internal organs and meridians, obstructing the qi mechanism, and easily causing internal depression and heat; heat is a yang evil, and it can easily turn into dryness and damage yin. If dampness and heat are blocked in the middle of the body, the spleen and stomach will not function properly, and the essence and microorganisms cannot be transported and transformed to nourish the internal organs of the body, resulting in symptoms such as abdominal distension, thirst and desire to drink or not drinking much or not relieving thirst after drinking, eating a lot or eating little and having poor appetite, loose stools and discomfort, and heavy limbs. Over time, it affects the circulation of qi and blood in the body, dampness and heat block the meridians, and then blood stasis is generated, the meridians are blocked, and other diseases are easily caused.

[0009] Based on the theory of traditional Chinese medicine and combined with the clinical practice process, the inventor found that for patients with TCM spleen deficiency and damp-heat pathogenesis characteristics in the treatment of diabetic insulin resistance, the prescriptions and medicines based on the principles of strengthening the spleen and replenishing qi, clearing away heat and removing dampness have significant effects. The present invention provides a Chinese medicine composition for treating diabetic insulin resistance, which is matched with spleen-strengthening and qi-replenishing medicines and heat-clearing and damp-removing medicines, and tonifies yin and raises yang at the same time, so that the yin and yang of the spleen are mutually generated, and dampness-drying and heat-clearing are used at the same time, so that dampness and heat evil are removed, and the spleen is strengthened, heat-clearing and dampness-removing are played together, and the efficacy is significant in improving the symptoms and signs of diabetic insulin resistance and improving the quality of life of patients.

[0010] In summary, the inventors of the present invention adhere to the viewpoint of treating the disease from the spleen, believe that strengthening the spleen and replenishing qi, clearing away heat and removing dampness are the key, taking into account nourishing yin, and restoring the functions of raising the clear and lowering the turbid, and making the evil retreat without hurting the body, so as to achieve the effect of improving the patient's diabetes insulin resistance. The above is the treatment mechanism proposed by the inventors, and it is applied to the specific treatment process.

[0011] On the basis of the above-mentioned treatment mechanism and in combination with the action mechanism of relevant drugs, the specific technical solution provided by the inventor is as follows.

[0012] A Chinese medicine composition for treating diabetic insulin resistance, the main components of which are calculated by weight:

[0013] 20-40 parts of Astragalus, 15-25 parts of Pueraria, 12-18 parts of stir-fried Atractylodes, 20-40 parts of Morus twig, 9-15 parts of Salvia miltiorrhiza, 15-25 parts of Radix Trichosanthis, 20-40 parts of Dioscorea opposita, 12-18 parts of Lablab cynomorium, 9-15 parts of Amomum villosum, 9-15 parts of Euryale ferox, and 9-15 parts of silkworm feces.

[0014] The best therapeutic effect can be obtained within the above dosage range. Too much or too little drug dosage will lead to changes in the priority of the pathogenesis around which the prescription is formulated.

[0015] Preferably, the above-mentioned Chinese medicine composition for treating diabetic insulin resistance has the following main components by weight:

[0016] 21-39 parts of Astragalus, 16-24 parts of Pueraria, 13-17 parts of stir-fried Atractylodes, 21-39 parts of Morus twig, 10-14 parts of Salvia miltiorrhiza, 16-24 parts of Radix Trichosanthis, 21-39 parts of Dioscorea opposita, 13-17 parts of White Laba, 10-14 parts of Amomum villosum, 10-14 parts of Euryale ferox, and 10-14 parts of Silkworm excrement.

[0017] In the prescription of the present invention, Astragalus is the main ingredient. Astragalus is sweet and slightly warm. It has the functions of nourishing the Qi of the spleen and lungs, nourishing the Qi and strengthening the exterior, nourishing the blood and activating the blood circulation, as well as the effects of raising the Yang and lifting the sunken, nourishing the vital energy of the spleen and stomach, and the metabolism can be carried out when the Qi in the middle is full.

[0018] Pueraria root, Chinese yam, stir-fried Atractylodes macrocephala, mulberry branch, salvia miltiorrhiza, and Radix Trichosanthis are the ministers. Pueraria root is sweet, pungent, and cool, and has the functions of relieving muscle and reducing fever, promoting fluid and quenching thirst, raising yang and stopping diarrhea, and promoting blood circulation; Chinese yam is sweet and flat, and can strengthen the spleen and replenish deficiency, nourish the kidney and benefit the essence, and benefit the stomach yin; Chinese yam is good at replenishing the qi and yin of the spleen, and it is combined with the yang-raising Pueraria root. The yin and yang of the spleen can be mutually rooted and mutually generated, which greatly helps the spleen to move, and replenishes without stagnation. Stir-fried Atractylodes macrocephala is bitter, sweet, and warm, and can strengthen the spleen and replenish qi, dry dampness and promote diuresis. Mulberry branch is slightly bitter and flat, and can eliminate rheumatism and benefit joints. Salvia miltiorrhiza is bitter and slightly cold, and can clear heat and promote blood circulation. Radix Trichosanthis is sweet, slightly bitter, and slightly cold, and has the functions of clearing heat and purging fire, promoting fluid and quenching thirst. All the medicines are ministers, and they can replenish the spleen and replenish qi and clear heat and transform dampness, while taking into account nourishing yin and activating blood circulation, so that the evil is removed without hurting the body, and the dampness is transformed without hurting the yin.

[0019] With white lentil, Euryale ferox and silkworm excrement as adjuvants, white lentil is sweet and slightly warm, which can help the monarch and ministers to strengthen the spleen and dissolve dampness; Euryale ferox is sweet, astringent and flat, which can nourish the spleen and dispel dampness, benefit the kidney and consolidate the essence; silkworm excrement is pungent, sweet and warm, which has the effects of dispelling wind and dampness, harmonizing the stomach and removing turbidity, and promoting blood circulation and menstruation. With Amomum villosum as the envoy, it is pungent, warm and fragrant, which can stimulate the appetite and wake up the spleen, dispel dampness and stop diarrhea, so that other drugs will not stay. All the drugs are compatible, and they play the role of strengthening the spleen and replenishing qi, clearing heat and removing dampness.

[0020] The more specific Chinese and Western medicine mechanisms for each medicine are as follows:

[0021] Astragalus: first seen in "Wu Er Bing Fang", it is slightly warm in nature, sweet in taste, and belongs to the lung and spleen meridians. It has multiple functions such as replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling. Astragalus contains chemical components such as polysaccharides, saponins, flavonoids, and amino acids. Astragalus is particularly effective in replenishing qi. "Ben Cao Qiu Zhen" records: "Astragalus is sweet in taste and warm in nature, light in texture, with yellow skin and white flesh, so it can enter the lungs to replenish qi, enter the exterior and strengthen the defense, and is the best of all qi-replenishing medicines, so it is called astragalus." Astragalus polysaccharide achieves insulin sensitization and hypoglycemic activity by reducing the expression and activity of protein tyrosine phosphatase 1B (PTP1B) in skeletal muscle of streptozotocin-induced T2DM rats. Astragalus polysaccharide can regulate some insulin signals in IR skeletal muscle and may become a potential insulin sensitizer for the treatment of T2DM.

[0022] Pueraria root: sweet, pungent, cool in nature, sweet and pungent, light and ascending, flat and slightly cool, can clear, enter the spleen, stomach, and lung meridians, and has the effects of relieving muscle and fever, clearing rashes, promoting body fluid and quenching thirst, raising yang and stopping diarrhea, promoting blood circulation and activating collaterals, and detoxifying alcohol. The "Ben Jing" has a discussion: "It can relieve thirst, cause fever, vomiting, and all kinds of numbness, raise yin qi, and detoxify all kinds of poisons." A large number of pharmacological studies have shown that puerarin and other puerarin isoflavones can play a hypoglycemic role by increasing glucose uptake and glucose tolerance, improving IR, and protecting pancreatic β cells. Daidzein can increase insulin sensitivity by increasing adenylate-activated protein kinase (AMPK) phosphorylation and glucose transporter 4 (GLUT4) expression, as well as promoting glucose uptake. Other studies have shown that 3'-hydroxypuerarin can promote glucose utilization in IR adipocytes and inhibit free fatty acid production, thereby improving IR, and its mechanism may be related to upregulating PPARγ gene expression.

[0023] Stir-fried Atractylodes macrocephala: bitter, sweet, warm, and enters the spleen and stomach meridians. It can strengthen the spleen and replenish qi, dry dampness and promote diuresis, and consolidate the surface and stop sweating. The Atractylodes macrocephala sugar complex AMP-B isolated from the crude polysaccharide of Atractylodes macrocephala has obvious hypoglycemic activity, and the mechanism may be to weaken the damage of alloxan to pancreatic β cells or improve the function of damaged β cells. After 6 weeks of oral administration of Atractylodes macrocephala volatile oil, hyperglycemia, hyperinsulinemia and insulin sensitivity in the serum of rats with metabolic syndrome were significantly improved, indicating that Atractylodes macrocephala volatile oil can reduce the fasting blood glucose (FBG) of rats by reducing the body's IR and improving insulin sensitivity, thereby effectively improving glucose and lipid metabolism. Experiments have shown that continuous administration of Atractylodes macrocephala ethanol extract (AMK) significantly reduced the FBG level of spontaneous type 2 diabetic db / db mice, significantly increased the fasting serum insulin level, and improved IR. It is believed that AMK may exert its hypoglycemic effect by increasing insulin secretion and promoting the proliferation of pancreatic β cells.

[0024] Mulberry branch: slightly bitter, neutral in nature, enters the liver meridian, dispels rheumatism, and benefits joints. "Compendium of Materia Medica" says that mulberry branch: benefits joints, nourishes body fluids, promotes water circulation and dispels wind. A large number of studies have shown that the polyhydroxyalkaloid component 1-DNJ in mulberry is its main active ingredient for lowering blood sugar. In addition, the alcohol extract of mulberry branch can promote insulin secretion and sensitivity. The flavonoid components morusin, quercetin, sanggenon C, and kuwanon G in mulberry branch also have a certain inhibitory activity of α-glucosidase, indicating that other non-polyhydroxyalkaloid components in mulberry branch also have a hypoglycemic effect.

[0025] Danshen: It was first recorded in Shennong's Herbal Classic and was listed as a top-grade medicine. It is bitter, slightly cold, and enters the heart and liver meridians. Bitterness can dissipate, and slightly cold can clear. It can not only activate blood circulation, remove blood stasis, and relieve pain, but also clear the heart and cool the blood to eliminate restlessness and eliminate carbuncle. Experiments have shown that Danshen extract can improve glucose metabolism disorders by reducing the FBG level of mice; Salvianolic acid B can improve diabetes-induced endothelial cell and mitochondrial dysfunction, and improve insulin resistance in ob / ob mice by inhibiting liver endoplasmic reticulum stress; Tanshinone I can reduce the levels of interleukin-6 (IL-6) and tumor necrosis factor α (TNF-α) in insulin receptor substrate-1 (IRS-1), reduce the nuclear translocation of NF-κB and phosphorylation of serine 307 (Ser307), and regulate the AMPK signaling pathway to improve IR in T2DMdb / db mice. The above studies show that reducing the body's insulin level and increasing insulin sensitivity may be important common mechanisms for Danshen to play a protective role against diseases induced by glucose metabolism disorders.

[0026] Radix Trichosanthis: sweet, slightly bitter, slightly cold, enters the lung and stomach meridians, can clear away heat and purge fire, promote the production of body fluids and quench thirst, reduce swelling and discharge pus. "Compendium of Materia Medica" states: "The root of Trichosanthes kirilowii is sweet, slightly bitter and sour. Sourness can promote the production of body fluids, so it can quench thirst and moisten dryness. It is slightly bitter and reduces fire, and sweetness does not hurt the stomach. Ancient people only said that it is bitter and cold, but they did not observe it deeply." Modern pharmacological studies have shown that the main components of Radix Trichosanthis, such as TKL, Radix Trichosanthis polysaccharides, total saponins, and citrulline, all have significant hypoglycemic effects. Gavage of Radix Trichosanthis to diabetic rats can reduce FBG in rats, showing a dose- and time-dependent relationship, and no adverse reactions such as abdominal distension, diarrhea, and anorexia occur.

[0027] Chinese Yam: From the Tang Dynasty Hou Ningji's "Pharmacopoeia", it is sweet, mild, and can strengthen the spleen and replenish deficiency, nourish the kidney and benefit the essence, and benefit the stomach yin. Chinese Yam polysaccharides can significantly lower blood sugar, and its mechanism of action may be related to restoring insulin secretion function, improving damaged pancreatic β cell function, and removing excess free radicals. It can also increase insulin sensitivity and improve insulin signal transduction pathways.

[0028] White lentil: sweet in taste, slightly warm in nature, sweet tonic and detoxifying, slightly warm to eliminate dampness, enter the spleen and stomach meridians, can not only strengthen the spleen and eliminate dampness, but also eliminate dampness and harmonize the middle, relieve summer heat and stop diarrhea, and can also detoxify alcohol. Studies have found that 16 saponin components were identified from white lentil kernels, which mediate the inflammatory response of the disease, signal transduction and other processes by regulating several key proteins that interact with the epidermal growth factor receptor (EGFR) and a series of signal pathways related to the development of the disease, thereby synergistically treating diabetes with multiple components and multiple targets. The results of the study showed that white lentil polysaccharides can improve the IR level of T2DM rats by regulating blood lipid metabolism levels and inhibiting the hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis, thereby exerting a hypoglycemic effect.

[0029] Amomum villosum: spicy, warm in nature, enters the spleen, stomach, and kidney meridians, and has the effects of removing dampness and stimulating appetite, warming the spleen and stopping diarrhea, regulating qi and calming the fetus. Studies have found that the water extract of Amomum villosum can reduce the blood glucose level of rats, and has a good protective effect on the pancreatic β cells of rats, and can also improve the ultrastructure of insulin β cells to a certain extent; the ethanol extract of Amomum villosum has the activity of promoting glucagon-like peptide-1 (GLP-1) secretion and glycogen phosphorylase a (GPa); it has been reported that the cyperane-type and norcyperane-type diterpenes isolated from the roots of Amomum villosum have α-glucosidase inhibitory activity; the 8 terpenoid compounds isolated and identified from Amomum villosum can promote the secretion of GLP-1 in the mouse small intestinal endocrine cell (STC-1) model, have strong inhibitory activity on GPa, and have moderate inhibitory activity on PTP1B.

[0030] Gorgon fruit: sweet, astringent, neutral in nature, enters the spleen and kidney meridians, sweet, astringent, neutral and not biased, and mild in medicinal power. It can nourish the spleen and remove dampness, benefit the kidney and consolidate the essence, and has the advantages of nourishing without being greasy, astringent without retaining dampness. It is mainly used to treat spleen deficiency, chronic diarrhea and kidney deficiency. Modern pharmacological studies have confirmed that Gorgon fruit polysaccharides can increase glucose consumption and improve IR by activating the activity of the phosphatidylinositide 3-kinase (PI3K) / protein kinase B (Akt) signaling pathway in the insulin resistance model of human liver cancer HepG2 cells and upregulating the expression of glucose transporter 4. 2β-hydroxybetulinic acid 3β-oleate isolated from Gorgon fruit can significantly reduce the blood glucose and blood lipid levels in rats with T2DM model induced by streptozotocin.

[0031] Silkworm excrement: Spicy and sweet, can dissipate and moisten, warm in nature, enters the stomach, spleen, and liver meridians, can dispel wind and dampness, harmonize the stomach and eliminate turbidity, and activate blood circulation and dredge the menstruation. "Ming Yi Bie Lu" clearly states that it can treat "diabetes", and "Ben Cao Qiu Zhen" records that "because silkworms eat but do not drink, the food comes out and the air is dry...dryness and heat cause diabetes, and this pungent ingredient can moisten it." The main active ingredient of silkworm excrement extract that lowers blood sugar is 1-deoxynojirimycin, which belongs to the class of α-glucosidase inhibitors. It mainly inhibits the decomposition of oligosaccharides into glucose and prevents the absorption of starch and other substances by the small intestine, thereby achieving the purpose of lowering blood sugar. Animal experimental studies have found that silkworm excrement extract can significantly reduce the blood sugar peak and area under the blood sugar curve after sucrose or starch loading in normal mice and high-sugar mice, and shift the blood sugar peak later.

[0032] Furthermore, the inventors have rationally optimized the components of the above-mentioned Chinese medicine composition and finally obtained the following technical solution: The main components of the Chinese medicine composition are calculated by weight:

[0033] 30 parts of Astragalus, 20 parts of Pueraria, 15 parts of stir-fried Atractylodes, 30 parts of Morus, 12 parts of Salvia miltiorrhiza, 20 parts of Radix Trichosanthis, 30 parts of Dioscorea opposita, 15 parts of Lablab datura, 12 parts of Amomum villosum, 12 parts of Euryale ferox, and 12 parts of silkworm excrement.

[0034] On the basis of the above-mentioned drug composition, the inventor further provides a method for preparing the above-mentioned Chinese medicine composition, and a method for using the obtained Chinese medicine decoction.

[0035] First, weigh out each Chinese medicine according to the ratio of the raw materials, then add water until the surface of the medicine is covered by 3-5 cm, soak for 1.5 hours, boil over high heat, then simmer for 40-50 minutes, filter out the juice for later use, add water to the residue again, until the surface of the residue is covered by 2-3 cm, boil over high heat, then simmer for 20-30 minutes, filter out the juice and combine it with the previous juice to get the Chinese medicine decoction.

[0036] Directions: Take 1 dose daily, divided into morning and evening, warm and drink 1-2 hours after meals.

[0037] The medicine obtained by the prescription and preparation method of the present invention is applied to clinical practice, and the curative effect is very significant. The inventor has proved through a large number of experiments that compared with metformin, a commonly used drug for treating diabetes insulin resistance in clinical practice, the pharmaceutical composition of the present invention has a significant curative effect, and has significant advantages in reducing blood sugar, improving insulin resistance, alleviating clinical symptoms, and improving the quality of life of patients. Therefore, the technical scheme of the present invention has obvious advantages from theory to clinical effect. In actual conditions, the prescription of the present invention can be selected for use in conjunction with Western medicine (such as metformin).

[0038] In summary, the present invention is based on traditional Chinese medicine theory and combined with clinical practice to obtain a Chinese medicine composition specifically for the treatment of diabetic insulin resistance. It takes invigorating the spleen and replenishing qi, clearing away heat and removing dampness as the principles, and uses both tonifying yin and raising yang to make the yin and yang of the spleen complement each other, and uses both drying dampness and clearing heat to remove dampness and heat evil, and together they have the effect of invigorating the spleen, clearing heat and removing dampness, and has a significant effect on improving the symptoms and signs of diabetic insulin resistance and improving the quality of life of patients. DETAILED DESCRIPTION

[0039] The present invention is not limited by the following embodiments. The following embodiments and descriptions are only for illustrating the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may be subject to various changes and improvements, and these changes and improvements all fall within the scope of the present invention to be protected.

[0040] Example 1

[0041] A Chinese medicine composition for treating diabetic insulin resistance, prepared from the following medicines:

[0042] Astragalus 30g, Pueraria lobata 20g, stir-fried Atractylodes macrocephala 15g, mulberry branch 30g, Salvia miltiorrhiza 12g, Radix Trichosanthis 20g, yam 30g, white hyacinth bean 15g, Amomum villosum 12g, Euryale ferox 12g, silkworm feces 12g.

[0043] The preparation method is as follows:

[0044] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add cold water to cover the medicine surface by 3-5 cm, and soak for 1.5 hours;

[0045] (2) Boil the mixed raw materials over high heat, simmer over low heat for 45 minutes, and filter through gauze to obtain the filtrate and residue;

[0046] (3) adding hot water to the residue obtained in step (2) until the surface of the drug is covered by 2-3 cm, mixing and decocting, wherein the hot water is purified water at a temperature of 80° C., boiling over high heat, decocting over low heat for 25 minutes, and filtering again with gauze to obtain a filtrate and the residue;

[0047] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating diabetic insulin resistance.

[0048] Example 2

[0049] A Chinese medicine composition for treating diabetic insulin resistance, prepared from the following medicines:

[0050] Astragalus 20g, Pueraria lobata 15g, stir-fried Atractylodes macrocephala 12g, mulberry branch 20g, Salvia miltiorrhiza 9g, Radix Trichosanthis 15g, yam 20g, white hyacinth bean 12g, Amomum villosum 9g, Euryale ferox 9g, silkworm feces 9g.

[0051] The preparation method is as follows:

[0052] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add cold water to cover the medicine surface by 3-5 cm, and soak for 1.5 hours;

[0053] (2) Boil the mixed raw materials over high heat, simmer over low heat for 40 minutes, and filter through gauze to obtain the filtrate and residue;

[0054] (3) adding hot water to the medicinal residue obtained in step (2) until the medicinal surface is covered by 2-3 cm, mixing and decocting, wherein the hot water is purified water at a temperature of 80° C., boiling over high heat, decocting over low heat for 20 minutes, and filtering again with gauze to obtain a filtrate and medicinal residue;

[0055] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating diabetic insulin resistance.

[0056] Example 3

[0057] A Chinese medicine composition for treating diabetic insulin resistance, prepared from the following medicines:

[0058] 40g of Astragalus, 25g of Pueraria, 18g of stir-fried Atractylodes, 40g of Morus twig, 15g of Salvia miltiorrhiza, 25g of Radix Trichosanthis, 40g of Dioscorea opposita, 18g of White Laba, 15g of Amomum villosum, 15g of Euryale ferox, and 15g of Silkworm feces.

[0059] The preparation method is as follows:

[0060] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add cold water to cover the medicine surface by 3-5 cm, and soak for 1.5 hours;

[0061] (2) Boil the mixed raw materials over high heat, simmer over low heat for 50 minutes, and filter through gauze to obtain the filtrate and residue;

[0062] (3) adding hot water to the medicinal residue obtained in step (2) until the medicinal surface is covered by 2-3 cm, mixing and decocting, wherein the hot water is purified water at a temperature of 80° C., boiling over high heat, decocting over low heat for 30 minutes, and filtering again with gauze to obtain a filtrate and medicinal residue;

[0063] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating diabetic insulin resistance.

[0064] Experimental example

[0065] 1. Clinical data

[0066] 1.1 Source of research subjects and sample size:

[0067] Research subjects: A total of 60 patients who have been diagnosed with diabetic insulin resistance, meet the diagnosis of TCM syndrome and require drug intervention were selected in this case. The case data came from outpatient and inpatient patients of the Endocrinology Department of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from September 2021 to December 2023.

[0068] 1.2 Diagnostic criteria:

[0069] 1.2.1 Western medicine diagnostic criteria:

[0070] 1.2.1.1 Diagnostic criteria for diabetes:

[0071] According to the diagnostic criteria for diabetes in the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", patients have typical symptoms of diabetes (polydipsia, polyphagia, polyuria, unexplained weight loss) and any of the following:

[0072] (1) Random venous plasma glucose ≥11.1 mmol / L;

[0073] (2) or fasting venous plasma glucose ≥7.0 mmol / L;

[0074] (3) Or oral glucose tolerance test 2h (OGTT2h) plasma glucose ≥11.1mmol / L;

[0075] (4) Or glycated hemoglobin HbA1 c ≥ 6.5%.

[0076] Note: Random blood sugar refers to blood sugar at any time of the day without considering the last meal time. It cannot be used to diagnose impaired fasting glucose or impaired glucose tolerance. Fasting state refers to no caloric intake for at least 8 hours. If typical symptoms of diabetes do not appear, recheck and confirm on another day.

[0077] 1.2.1.2 Diagnostic criteria for insulin resistance

[0078] With reference to the "Expert Guidance on the Methods and Applications of Insulin Resistance Assessment" and "Insulin Resistance Assessment and Its Clinical Application" published by the Diabetes Branch of the Chinese Medical Association, the insulin resistance index (HOMA-I R) = FPG (mmol / L) × FINS (μU / mL) / 22.5 ≥ 2.69 was used as the inclusion criterion.

[0079] 1.2.2 TCM syndrome diagnostic criteria

[0080] The following is formulated with reference to the "TCM Clinical Diagnosis and Treatment Terminology Syndrome Section" issued by the State Administration of Technical Supervision of the People's Republic of China in 1997 and the 2016 edition of the "TCM Clinical Evidence-Based Practice Guidelines for Diabetes":

[0081] Main symptoms: ① Poor appetite; ② Chest and abdominal distension; ③ Heaviness in the head and body.

[0082] Secondary symptoms: ④ Fatigue; ⑤ Loose or sticky stools.

[0083] Tongue and pulse: red tongue; tooth marks on the edges of the tongue; yellow and slippery or yellow and greasy tongue coating; slippery and rapid pulse.

[0084] Among them, two of the main symptoms plus one of the secondary symptoms, with reference to the tongue and pulse, the syndrome can be diagnosed as spleen deficiency and damp-heat syndrome.

[0085] 1.3 Case selection criteria

[0086] 1.3.1 Inclusion criteria

[0087] ①Those who meet the Western medical diagnostic criteria for diabetes;

[0088] ②Those who meet the TCM diagnosis and syndrome differentiation and belong to the spleen deficiency dampness heat type;

[0089] ③ Aged between 18 and 70 years old, regardless of gender;

[0090] ④ Those who voluntarily join this trial study, can cooperate with treatment and examination, and sign the informed consent.

[0091] 1.3.2 Exclusion criteria

[0092] ① Those who do not meet the inclusion criteria;

[0093] ② Type Ⅰ diabetes, gestational diabetes and special types of diabetes;

[0094] ③ Patients with acute complications of diabetes (ketoacidosis, hyperosmolar coma, lactic acidosis, etc.);

[0095] ④ Patients with severe heart, brain, liver, kidney, and digestive system diseases;

[0096] ⑤ Pregnant or lactating women;

[0097] ⑥People with allergic constitution or allergic to drugs;

[0098] ⑦ Those who are uncooperative or have mental or psychological illnesses;

[0099] ⑧ Those who have experienced severe gastrointestinal reactions after oral administration of metformin.

[0100] 1.3.3 Shedding Standard

[0101] Patients who met the inclusion criteria but failed to complete the treatment course and observation period of this program as required due to adverse reactions, ineffective treatment, patient loss to follow-up, automatic withdrawal, poor compliance, etc. after informed consent were all dropout cases.

[0102] 1.3.4 Elimination criteria

[0103] Those who did not use the medication according to the regulations, used other drugs privately, and affected the clinical efficacy and safety evaluation, and those who developed severe acute complications such as ketoacidosis after treatment were all excluded.

[0104] 2. Research Methods

[0105] 2.1 Study design

[0106] 60 patients diagnosed with spleen deficiency and damp-heat syndrome among patients with diabetes insulin resistance who met the diagnostic criteria of Western medicine were selected, and they were randomly divided into a test group and a control group using a random number table method, with 30 cases in each group. The clinical efficacy was observed by comparing the pharmaceutical composition treatment of Example 1 (the process and dosage of Example 1 were used to decoct 200ml of Chinese medicine decoction, which was taken warm twice in the morning and evening, 100ml each time) and metformin. The treatment course was 8 weeks, and the changes in the quantitative score of the TCM syndrome of the diabetes insulin resistance (spleen deficiency and damp-heat syndrome) diagnostic scale and the changes in the experimental value index of the two groups of patients before and after treatment were observed. After the end of the course of treatment, all data were statistically analyzed using the statistical software SPSS27.0, and the differences before and after treatment in the test group and the control group and between the two groups were compared.

[0107] 2.2 Treatment methods

[0108] 2.2.1 Basic treatment

[0109] ① Diabetes self-management education;

[0110] ② Control diet: Refer to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", according to 105-126KJ (25-30kcal) kg -1 (Standard weight) d -1 Calculate energy intake. Overweight or obese diabetic patients should control their total energy intake, adjust their eating habits, and lose at least 5% of their body weight.

[0111] ③ Moderate exercise: Perform moderate-intensity aerobic exercise for no less than 150 minutes per week, such as Tai Chi, cycling, brisk walking, swimming, ball games, aerobics, resistance exercise, etc. Make an exercise plan based on your own situation and tolerance.

[0112] 2.2.2 Group treatment

[0113] ① Experimental group: treated with the pharmaceutical composition of Example 1 (200 ml of the medicinal solution was obtained by decocting using the process and dosage of Example 1, and taken warm twice a day, morning and evening, 100 ml each time).

[0114] ②Control group: Use metformin hydrochloride tablets (Glucophage, specification: 0.5g / tablet, national medicine standard number H20023370, produced by Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.), 0.5g each time, 3 times a day, orally before meals.

[0115] The observation period for both the experimental group and the control group was 8 weeks, followed by regular follow-up to understand the improvement of patients' subjective symptoms and laboratory tests before and after treatment and record their adverse reactions.

[0116] 2.3 Observation indicators

[0117] 2.3.1 Safety indicators

[0118] ① General physical examination: such as height, weight, heart rate, blood pressure, etc.;

[0119] ② Blood, urine, stool routine, liver and kidney function, electrocardiogram, once before and after treatment;

[0120] ③ Closely observe the patient for any adverse reactions.

[0121] 2.3.2 Efficacy indicators

[0122] ① Fasting blood glucose (FPG) and 2-hour postprandial blood glucose (2hPG) were observed and recorded once a week;

[0123] ②Fasting insulin (FINS), glycosylated hemoglobin (HbA1 c), total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C) were checked and recorded once before and after treatment; insulin resistance index (HOMA-IR) and pancreatic β-cell function index (HOMA-β) were calculated once before and after treatment;

[0124] Note: IR was evaluated by insulin resistance index (HOMA-IR) and pancreatic β-cell function index (HOMA-β). Calculation formula: HOMA-IR = FPG × FI NS / 22.5; HOMA-β = 20 × FI NS / (FPG-3.5)

[0125] ③ TCM symptom index: TCM syndrome score was assessed once before and after treatment.

[0126] 2.4 Efficacy evaluation criteria

[0127] 2.4.1 Criteria for determining efficacy of TCM syndromes

[0128] With reference to the "Guidelines for Clinical Research of New Chinese Medicines", the following standards are formulated based on changes in clinical symptoms and signs:

[0129] The efficacy index formula (nimodipine method) is: [(pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%.

[0130] (1) Significantly effective: clinical symptoms and signs of TCM were significantly improved, and the syndrome score was reduced by ≥70%;

[0131] (2) Effective: clinical symptoms and signs of TCM have improved, and the syndrome score has decreased by ≥30%;

[0132] (3) Ineffective: There is no significant improvement in TCM clinical symptoms and signs, or they may even worsen, and the symptom score decreases by less than 30%.

[0133] 2.4.2 Criteria for determining blood sugar efficacy

[0134] Markedly effective: FPG and 2hPG decreased to the normal range, or decreased by more than 40% before treatment; HbA1c value decreased to normal, or decreased by more than 30% before treatment;

[0135] Effective: FPG and 2hPG decreased by more than 20% before treatment, but did not meet the standard of marked effect; HbA1c value decreased by more than 10% before treatment, but did not meet the standard of marked effect;

[0136] Invalid: FPG and 2hPG did not decrease, or the decrease did not meet the effective standard; HbA1c value did not decrease, or the decrease did not meet the effective standard.

[0137] 2.5 Statistical methods

[0138] Statistical analysis: An Excel database was established and SPSS 27.0 statistical software was used for data analysis. The data followed a normal distribution and the measurement data were expressed as mean ± standard deviation. The data were described by t test if the variance was equal, and by approximate t test if the variance was not equal. The count data were described by rate (%) and chi-square (χ 2 ) test; the rank data and data that did not conform to the normal distribution were described by the median and interquartile range, and the non-parametric rank sum test was used. All statistical methods were two-sided tests, and the differences were statistically significant when P < 0.05.

[0139] 3. Results and Analysis

[0140] 3.1 General Information

[0141] All patients were from the outpatient and inpatient departments of the Department of Endocrinology of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from September 2021 to December 2023, with a total of 60 cases (n), 30 cases in the experimental group and 30 cases in the control group. No cases dropped out during the treatment in both groups. Among them, there were 17 males and 13 females in the experimental group, with an average age of (48.32±11.55) years old; there were 14 males and 16 females in the control group, with an average age of (51.49±9.00) years old; there was no statistical difference (P>0.05) in gender (P=0.438), age (P=0.779), and course of disease (P=0.476) between the two groups before treatment, and they were comparable (see Tables 1, 2, and 3).

[0142] Table 1 Comparison of gender between the two groups of patients

[0143]

[0144] Note: 2 Test, P = 0.438> 0.05, there is no statistically significant difference between genders, and comparison can be made.

[0145] Table 2 Comparison of age between the two groups of patients

[0146]

[0147] Note: According to the independent sample t-test, P=0.799>0.05, there is no statistically significant difference in age, so comparison can be made.

[0148] Table 3 Comparison of disease course between the two groups

[0149]

[0150] Note: According to the independent sample t test, P=0.476>0.05, there is no statistically significant difference in the course of disease, and comparison can be made.

[0151] 3.2 Comparison of efficacy indicators between the two groups before and after treatment

[0152] 3.2.1 Comparison of blood sugar levels before and after treatment between the two groups of patients (Table 4)

[0153] Table 4 Comparison of blood sugar indexes between the two groups of patients before and after treatment

[0154]

[0155]

[0156] After testing, before treatment, the two groups had no significant difference in FPG, 2hPG, and HbA1c, P>0.05, and the difference was comparable. After treatment, the two groups had a decrease in FPG, 2hPG, and HbA1c, P<0.01, and the difference was statistically significant, indicating that both the experimental group and the control group could significantly reduce FPG, 2hPG, and HbA1c. After treatment, the two groups had a significant difference in 2hPG (P=0.002<0.01), and the difference in HbA1c (P=0.017<0.05), indicating that the experimental group had a more obvious effect in reducing 2hPG and HbA1c; FPG (P=0.097>0.05) had no statistically significant difference.

[0157] 3.2.2 Comparison of blood lipids between the two groups of patients before and after treatment (Table 5)

[0158] Table 5 Comparison of blood lipid indexes between the two groups of patients before and after treatment

[0159]

[0160] After testing, the TG, TC, and LDL-C levels of the two groups before treatment were compared, P>0.05, and there was no statistically significant difference, which was comparable. After treatment, the TG, TC, and LDL-C levels of the two groups decreased compared with those before treatment. Among them, the TG and TC of the experimental group and the TC of the control group, P<0.01, and the difference was statistically significant. The LDL-C of the experimental group and the TG and LDL-C of the control group, P<0.05, and the difference was statistically significant, indicating that both the experimental group and the control group could reduce TG, TC, and LDL-C. After treatment, the inter-group comparison showed that the differences in TG (P=0.007<0.01) and TC (P=0.001<0.01) were statistically significant, indicating that the experimental group had a more obvious effect in reducing TG and TC; there was no statistically significant difference in LDL-C (P=0.480>0.05).

[0161] 3.2.3 Comparison of FINS, HOMA-IR, and HOMA-β between the two groups before and after treatment (Table 6)

[0162] Table 6 Comparison of FINS, HOMA-IR and HOMA-β between the two groups before and after treatment

[0163]

[0164] After testing, before treatment, the two groups were compared with each other in FINS, HOMA-IR, and HOMA-β, P>0.05, with no significant difference, and they were comparable. After treatment, the two groups were compared within the same group, FINS and HOMA-IR decreased compared with before treatment, and HOMA-β increased compared with before treatment. Among them, the HOMA-IR, HOMA-β of the two groups and the FINS of the experimental group, P<0.01, had significant statistical differences, while the FINS of the control group (P=0.065>0.05) had no statistically significant difference, indicating that both groups could significantly reduce HOMA-IR and increase HOMA-β, and the experimental group could also significantly reduce FINS. After treatment, the intergroup comparison showed that FINS (P=0.037<0.05) and HOMA-IR (P=0.038<0.05) had significant differences, but HOMA-β (P=0.751>0.05) had no statistical significance.

[0165] 3.2.4 Comparison of TCM syndrome scores between the two groups of patients before and after treatment (Table 7)

[0166] Table 7 Comparison of TCM syndrome scores between the two groups of patients before and after treatment

[0167]

[0168] After testing, the TCM syndrome scores of the two groups before treatment were compared, P>0.05, the difference was not statistically significant, and they were comparable. After treatment, the TCM syndrome scores of the two groups were improved, P<0.01, and the difference was statistically significant, indicating that both the experimental group and the control group could significantly improve the TCM clinical symptoms. After treatment, the inter-group comparison was P<0.01, and the difference was statistically significant, indicating that the experimental group had a more obvious effect in improving the TCM clinical symptoms.

[0169] 3.2.5 Comparison of TCM symptoms efficacy between the two groups of patients (Table 8)

[0170] Table 8 Comparison of TCM syndrome efficacy between the two groups of patients

[0171]

[0172] Note: According to the rank sum test, Z=-2.175, P=0.03<0.05, the difference is statistically significant.

[0173] 3.3 Comparison of clinical recurrence rates between the two groups of patients (Table 9)

[0174] Table 9 Comparison of clinical recurrence rate

[0175]

[0176] Note: Four weeks after the end of treatment, 4 people in the experimental group relapsed, with a relapse rate of 13.33%, and 14 people in the control group relapsed, with a relapse rate of 46.66%. The difference was statistically significant (P<0.01).

[0177] 3.4 Security Analysis

[0178] No serious adverse reactions were reported in both groups during the trial, and all indicators showed no obvious abnormalities, indicating that the drug safety of this trial was good.

[0179] Specific cases

[0180] Case 1

[0181] Li, male, 42 years old, first diagnosed on July 2, 2022. Chief complaint: Blood sugar has been elevated for more than 3 years. The patient was found to have elevated blood sugar in a local hospital 3 years ago, with fasting blood sugar as high as 12.6mmol / L. He took metformin orally regularly, and his fasting blood sugar was controlled at 6-7mmol / L. He has not yet controlled his diet and exercised too little. His blood sugar is now poorly controlled, and his fasting blood sugar fluctuates between 11 and 12mmol / L, so he went to Professor Xu's outpatient clinic for medical treatment. Current symptoms: fatigue, sticky mouth, thirst without desire to drink, poor appetite, postprandial distension of the stomach, good sleep, regular urination, loose stools, once a day; pale tongue with tooth marks on the edges, yellow and greasy fur, and slippery and rapid pulse. Check: FPG9.5mmol / L, 2hPG13.1mmol / L, HbA1c8.3%, TG2.54mmol / L, TC5.76mmol / L, LDL-C3.52mmol / L, FINS18.04μU / mL, HOMA-IR7.62, HOMA-β60.13. Western medicine diagnosis: insulin resistance in diabetes; Chinese medicine diagnosis: thirst, spleen deficiency and damp-heat syndrome. Treatment: invigorating qi and strengthening spleen, clearing heat and removing dampness. Prescription: 30g of Astragalus, 20g of Pueraria root, 15g of stir-fried Atractylodes macrocephala, 15g of Morus alba, 12g of Salvia miltiorrhiza, 20g of Radix Trichosanthis, 30g of Dioscorea opposita, 15g of White Laba Bean, 12g of Amomum villosum, 12g of Euryale ferox, 12g of Silkworm feces, the Chinese medicine decoction obtained according to the preparation method of Example 1, 200ml per day,

[0182] Take warm medicine twice a day, morning and evening, 100ml each time, 14 packs;

[0183] Follow-up on July 16, 2022: The patient felt less tired and weak, and there was no significant change in other symptoms. The patient's appetite and sleep were good, and his bowel movements were normal. His tongue was pale with teeth marks on the edges, his tongue coating was white and greasy, and his pulse was slippery. Examination: FPG8.7mmol / L. Continue to take the above prescription, 28 packs;

[0184] Follow-up visit on August 13, 2022: The patient reported that his fatigue and weakness were significantly reduced, his thirst was relieved, his appetite and sleep were good, his bowel movements were normal, his tongue was pale red, his fur was thin and white, his pulse was slippery, and his FPG was 7.4 mmo l / L. He continued to take the above prescription, 14 packs;

[0185] Follow-up on August 27, 2022: The patient's symptoms were alleviated or disappeared, his appetite and sleep were good, his bowel movements were normal, his tongue was pale red, his fur was thin and white, and his pulse was smooth. Examination: FPG6.8mmo l / L, 2hPG9.1mmo l / L, HbA1c7.1%, TG1.92mmo l / L, TC4.32mmo l / L, LDL-C2.95mmo l / L, FINS14.25μU / mL, HOMA-IR4.31, HOMA-β86.36.

[0186] Case 2

[0187] Bai, male, 48 years old, first diagnosed on April 30, 2023. Chief complaint: found that blood sugar has been elevated for 8 years. Current medical history: The patient's FPG was measured at 9.1 mmol / L during a physical examination 8 years ago, and his fasting blood sugar was measured multiple times later.

[0188] 6.1mmo l / L, diagnosed as "type 2 diabetes", blood sugar up to 13mmo l / L, took metformin and other drugs as prescribed by the doctor, but the effect was not obvious, so he went to the outpatient department of endocrinology of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine for treatment. The current symptoms are: dry mouth, no desire to drink, fatigue, abdominal distension, poor appetite, good sleep, frequent flatulence, sticky stool, 2 times a day, regular urination. The tongue is light red, the tongue coating is yellow and greasy, the tongue is fat, there are teeth marks on the edges, and the pulse is deep and thin. Check: FPG10.3mmo l / L, 2hPG14.5mmo l / L, HbA1c9.7%, TG2.62mmo l / L, TC5.84mmo l / L, LDL-C3.51mmo l / L, FI NS19.11μU / mL, HOMA-I R8.75, HOMA-β56.21. Western medicine diagnosis: diabetes insulin resistance; Chinese medicine diagnosis: thirst, spleen deficiency and damp-heat syndrome. Treatment: invigorate qi and strengthen the spleen, clear away heat and eliminate dampness. Prescription: 30g of Astragalus, 20g of Pueraria root, 15g of stir-fried Atractylodes macrocephala, 15g of Morus alba, 12g of Salvia miltiorrhiza, 20g of Radix Trichosanthis, 30g of Dioscorea opposita, 15g of White Laba Bean, 12g of Amomum villosum, 12g of Euryale ferox, 12g of Silkworm excrement, the Chinese medicine decoction obtained according to the preparation method of Example 1, 1 dose of 200ml per day, warm and take twice a day in the morning and evening, 100ml each time, 14 packs;

[0189] Follow-up visit on May 14, 2023: The patient complained of dry mouth, abdominal distension and poor appetite, which were improved compared with before, but he still felt weak. His tongue was pale red with thin white fur, and the tongue was fat with teeth marks on the edges. His pulse was deep and thin. Examination showed that FPG was 9.5mmo l / L. He continued to take the above prescription for 28 packs;

[0190] Follow-up on May 11, 2023: Fatigue has improved significantly, with occasional backache, pale red tongue, thin white fur, enlarged tongue, deep and fine pulse, FPG 8.3mmo l / L. Continue to take the above prescription, 14 packs;

[0191] Follow-up on May 25, 2023: The patient did not complain of obvious discomfort, with pale red tongue, thin white fur, and fine pulse. Examination: FPG7.1mmol / L, 2hPG9.8mmo l / L, HbA1c7.8%, TG1.98mmo l / L, TC4.25mmo l / L, LDL-C2.58mmo l / L, FINS15.02μU / mL, HOMA-I R4.74, HOMA-β83.44.

[0192] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any equivalent substitutions, modifications, etc. made by technicians in this field without any creative work within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating diabetic insulin resistance, characterized in that: Its main components are calculated by weight: 20-40 parts of astragalus, 15-25 parts of kudzu root, 12-18 parts of stir-fried atractylodes, 20-40 parts of mulberry branches, 9-15 parts of salvia miltiorrhiza, 15-25 parts of trichosanthes, 20-40 parts of yam, 12-18 parts of white hyacinth bean, 9-15 parts of amomum, 9-15 parts of euryale ferox, and 9-15 parts of silkworm feces.

2. The Chinese medicine composition for treating diabetic insulin resistance according to claim 1, characterized in that: Its main components are calculated by weight: 21-39 parts of astragalus, 16-24 parts of kudzu root, 13-17 parts of stir-fried atractylodes, 21-39 parts of mulberry branches, 10-14 parts of salvia miltiorrhiza, 16-24 parts of trichosanthes, 21-39 parts of yam, 13-17 parts of white hyacinth bean, 10-14 parts of amomum, 10-14 parts of euryale ferox, and 10-14 parts of silkworm feces.

3. The Chinese medicine composition for treating diabetic insulin resistance according to claim 2, characterized in that: The main components are calculated by weight as follows: 30 parts of astragalus, 20 parts of kudzu root, 15 parts of stir-fried atractylodes, 30 parts of mulberry branches, 12 parts of salvia miltiorrhiza, 20 parts of trichosanthes, 30 parts of yam, 15 parts of white hyacinth bean, 12 parts of amomum villosum, 12 parts of euryale ferox and 12 parts of silkworm feces.

4. The method for preparing the Chinese medicine composition for treating diabetic insulin resistance according to claim 1, characterized in that: The specific steps are as follows: first weigh each Chinese medicine according to the ratio of the raw materials, then add water until the surface of the medicine is 3-5 cm high, soak for 1.5 hours, boil over high heat, then simmer for 40-50 minutes, filter out the juice for later use, add water to the residue again, until the surface of the residue is 2-3 cm high, boil over high heat, then simmer for 20-30 minutes, filter out the juice and combine it with the above juice.

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