A traditional Chinese medicine composition for treating insulin resistance of diabetes and a preparation method thereof

Abstract

The application belongs to the technical field of diabetes drugs, and particularly relates to a traditional Chinese medicine composition for treating insulin resistance of diabetes and a preparation method thereof. Main components of the composition are as follows in terms of weight parts: 20-40 parts of Huangqi, 15-25 parts of Gegen, 12-18 parts of fried Baizhu, 20-40 parts of Sangzhi, 9-15 parts of Danshen, 15-25 parts of Tianhuafen, 20-40 parts of Shanyao, 12-18 parts of Baichandou, 9-15 parts of Sharen, 9-15 parts of Qianshi and 9-15 parts of Cansha. The traditional Chinese medicine composition is prepared by matching spleen-invigorating and qi-tonifying drugs with heat-clearing and dampness-removing drugs, and by matching yin tonifying with yang raising, so that yin and yang of the spleen are generated, dampness and heat evil are removed, and the functions of invigorating the spleen, clearing heat and removing dampness are achieved. The traditional Chinese medicine composition has remarkable curative effects on improving symptoms and signs of insulin resistance of diabetes and improving the life quality of patients.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of diabetes drugs, and particularly relates to a traditional Chinese medicine composition for treating insulin resistance of diabetes and a preparation method thereof. BACKGROUND

[0002] Diabetes is a progressive metabolic disease mainly characterized by persistent hyperglycemia. The pathogenesis of diabetes mainly includes insulin secretion deficiency, insulin resistance, increased secretion of glucagon, insufficient glucose uptake in muscle, decreased glycogenolysis and synthesis in liver, weakened action of incretin, increased glucose reabsorption in renal tubules, and weakened control of feeding center. Among them, insulin secretion deficiency refers to that the secretion amount of insulin in the body cannot meet the needs of sugar metabolism, which may be caused by various reasons, including decreased function of islet beta cells, damage of islet cells, autoimmunity, endocrine disorder, relative insulin deficiency, etc., and is the main pathogenesis of type 1 diabetes. Insulin resistance refers to that the metabolic response of insulin to insulin target organs and target tissues is reduced, or the response of blood glucose level to insulin is reduced or impaired, insulin regulates the uptake of glucose, and the disorder of insulin signal transduction will cause cells to be unable to uptake glucose, thereby causing hyperglycemia, which is the main pathogenesis of type 2 diabetes (T2DM), occurs in the early stage of T2DM, causes metabolic abnormalities in T2DM patients, and drives the occurrence and development of T2DM throughout the whole course 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 rate of 12.8%.

[0003] At present, the main drugs for treating insulin resistance of diabetes include biguanides, thiazolidinediones, alpha-glucosidase inhibitors, etc., which can reduce IR and improve the function of islet beta cells by increasing the sensitivity of tissues to insulin, increasing the number of insulin receptors, and regulating intestinal flora. However, with the progression of the disease and the gradual increase of dependence on exogenous substances, complications such as renal insufficiency are prone to occur, and the adverse reactions are obvious.

[0004] In today's flourishing of traditional Chinese medicine, 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 IR patients cannot have normal synergistic hypoglycemic response in target organs under normal serum insulin levels, including glucose uptake, synthesis of liver glycogen and muscle glycogen, inhibition of fat decomposition and inhibition of endogenous glucose production. And traditional Chinese medicine can reduce the activity of liver mitochondrial acetyl coenzyme A and phosphatidylcholine, inhibit gluconeogenesis and glycogenolysis, promote glycolysis to improve IR; By up-regulating the expression level of insulin signaling pathway related proteins, enhancing insulin receptor sensitivity, improving glucose uptake efficiency, improving IR, and reducing blood glucose level. Traditional Chinese medicine treatment not only can reduce the adverse reactions of western medicine, and can reduce the occurrence or delay the development of diabetic complications.

[0005] Therefore, exploring effective traditional Chinese medicine composition for preventing and treating insulin resistance in diabetes has become a difficult problem for Chinese medicine workers and the direction of research. SUMMARY

[0006] In view of the current situation that there is still lack of unified and effective treatment scheme for traditional Chinese medicine for preventing and treating insulin resistance in diabetes, the present application provides a traditional Chinese medicine composition for treating insulin resistance in diabetes and a preparation method thereof. The composition is composed of Huangqi, Gegen, Fried Baizhu, Sangzhi, Danshen, Tianhuafen, Shanyao, Baodianou, Sharen, Qianshi and Cansha, etc. The spleen qi and yin tonics are matched with heat-clearing and dampness-removing drugs, yin and yang are used together, dampness and heat are removed, and the functions of invigorating the spleen, clearing heat and removing dampness are achieved. The composition has remarkable curative effect on improving the symptoms and signs of insulin resistance in diabetes, improving the quality of life of patients, etc.

[0007] There is no record of insulin resistance in diabetes in ancient Chinese medical books. Modern physicians classify it as "consumption" "consumption" "spleen consumption". It is believed that the occurrence of the disease is related to improper diet, improper rest, etc. "Ancient and Modern Medical Encyclopedia·Consumption" says: "Although there are many different types of consumption, the root cause of the disease is the change of rich and delicious food, the damage of alcohol and sex, and the disease of the rich and the poor. The poor are rare. "If the five flavors are in harmony, the diet is appropriate, and the living is regular, the body's yin and yang will be in balance. If you prefer to eat, you can't rest, the viscera will be out of balance, and it will be easy to change into a disease. "Saints Record·Consumption" mentions: "…… Consumption is a disease of rich and delicious food. The accumulation of rich and delicious food causes spleen consumption. Once the consumption is established, it is a single yang without yin, and the evil heat is dominant. …… "The rich and delicious food is heavy and thick, and the wine is hot and wet. Overeating and overdrinking can easily damage the spleen and stomach, block the body's clear yang, and brew wet heat in the body. Over time, it will be hot and dry, and it will eventually become a diabetic.

[0008] The spleen and stomach are the acquired foundation of the body. If the root is damaged, various diseases will occur. The Canon of the Eight Principles states that the spleen is fragile and prone to disease and diabetes. It is believed that spleen deficiency is the main pathogenesis of diabetes. Patients usually like to eat spicy and delicious food, prefer to drink, and are overindulgent and lack of exercise, which causes the spleen to lose its transportation function, leading to the internal production of phlegm and dampness, and the transformation of heat over time. Therefore, the main site of insulin resistance in diabetes is the spleen, and the main pathogenesis is spleen deficiency and dampness. Insulin resistance in diabetes is mainly manifested as metabolic disorders of sugar, fat, and protein. The spleen is responsible for the transformation of water and food essence. If the spleen fails to transform, the clear qi will not rise, and the essence will descend, leading to diabetes. Wetness is a yin evil that easily damages yang qi. It is heavy and turbid, and stays between the viscera and meridians, causing the qi movement to be blocked and easily accumulating heat. Heat is a yang evil that easily dries and damages yin. If the dampness and heat are blocked, the spleen and stomach will lose their transportation function, the essence will not be transformed to nourish the viscera, and symptoms such as abdominal distension, polydipsia, or not much drinking, or drinking without relief, excessive eating or eating less, loose stools, and heavy limbs will occur. Over time, it will affect the movement of blood and qi in the body, and the dampness and heat will block the collaterals, leading to blood stasis and internal production of blood stasis, which will easily cause other diseases.

[0009] Based on the theory of traditional Chinese medicine and clinical practice, the inventors found that for patients with diabetes insulin resistance who meet the characteristics of spleen deficiency and dampness, using spleen and qi, and clearing heat and dampness, the curative effect is remarkable. The present application provides a traditional Chinese medicine composition for treating diabetes insulin resistance, which is composed of spleen and qi and clearing heat and dampness, and yin and yang, which can make the spleen yin and yang, and dryness and heat, which can make the wet and hot evil go away, and play the role of spleen and heat and dampness, which can improve the symptoms and signs of diabetes insulin resistance, and improve the quality of life of patients.

[0010] Based on the above, the inventors of the present application adhere to the view of treating from the spleen, and believe that spleen and qi, clearing heat and dampness are the key, and yin is also considered, and the function of ascending clear and descending turbid is restored, and the evil is removed without damaging the normal, so as to improve the effect of diabetes insulin resistance in patients. The above is the treatment mechanism proposed by the inventors, and it is applied to the specific treatment process.

[0011] Based on the above treatment mechanism, combined with the mechanism of related drugs, the specific technical scheme provided by the inventors is as follows.

[0012] A traditional Chinese medicine composition for treating diabetes insulin resistance, the main components are as follows in weight parts:

[0013] Radix Astragali 20-40 parts, Radix Puerariae 15-25 parts, Fried Atractylodes 12-18 parts, Ramulus Mori 20-40 parts, Salvia Miltiorrhiza 9-15 parts, Radix Trichosanthis 15-25 parts, Dioscorea 20-40 parts, White Lentil 12-18 parts, Amomum 9-15 parts, Gorgon Nut 9-15 parts, Silkworm Dung 9-15 parts.

[0014] The best therapeutic effect can be obtained in the above-mentioned dosage range, and too large or too small dosage of the medicine will cause the change of the pathogenesis around the prescription.

[0015] Preferably, the main components of the traditional Chinese medicine composition for treating insulin resistance of diabetes are as follows in terms of weight parts:

[0016] Huangqi 21-39 parts, Gegen 16-24 parts, Chuaobai 13-17 parts, Sangzhi 21-39 parts, Danshen 10-14 parts, Tianhuafen 16-24 parts, Shanyao 21-39 parts, Baodou 13-17 parts, Sharen 10-14 parts, Qianshi 10-14 parts, Cansha 10-14 parts.

[0017] In the prescription, Huangqi is the monarch, Huangqi is sweet and slightly warm, and has the functions of tonifying the lung and spleen qi, tonifying qi and consolidating the exterior, tonifying blood and activating blood, and lifting yang and relieving depression, and tonifying the original qi of the spleen and stomach.

[0018] Gegen, Shanyao, Chuaobai, Sangzhi, Danshen and Tianhuafen are the ministers, Gegen is sweet and pungent and has the functions of relieving the exterior, reducing fever, producing saliva and quenching thirst, lifting yang and relieving diarrhea, and activating the meridians; Shanyao is sweet and flat and has the functions of tonifying the spleen and invigorating deficiency, nourishing the kidney and essence, and tonifying the stomach yin; Shanyao is good at tonifying the spleen and yin, and is combined with Gegen to mutually root and generate yin and yang of the spleen, and greatly assist the spleen transportation, and tonifying without stagnation. Chuaobai is bitter and sweet and warm, and has the functions of invigorating the spleen and tonifying qi, drying dampness and promoting water. Sangzhi is slightly bitter and flat, and has the functions of expelling wind and dampness and benefiting the joints. Danshen is bitter and cold, and has the functions of clearing heat and activating blood. Tianhuafen is sweet, slightly bitter and cold, and has the functions of clearing heat and purging fire, producing saliva and quenching thirst. The combination of the above medicines is the minister medicine, and has the functions of tonifying the spleen and qi, clearing heat and dampness, and tonifying yin and activating blood, and removing evil without damaging the normal, and clearing dampness without damaging yin.

[0019] Baodou, Qianshi and Cansha are the adjuvants, Baodou is sweet and slightly warm, and has the functions of assisting the monarch and minister in invigorating the spleen and harmonizing the center and clearing dampness; Qianshi is sweet and astringent and flat, and has the functions of tonifying the spleen and expelling dampness, and tonifying the kidney and consolidating essence; Cansha is pungent and sweet and warm, and has the functions of expelling wind and dampness, harmonizing the stomach and turbid, activating blood and unblocking the meridians. Sharen is pungent and warm, and has the functions of opening the stomach and spleen, expelling dampness and stopping diarrhea, and making the other medicines not stagnate. The combination of the above medicines has the functions of invigorating the spleen and tonifying qi, clearing heat and dampness.

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

[0021] Radix Astragali: It was first recorded in the Fifty-two Prescriptions for Diseases, with mild-warm nature, sweet flavor, and lung and spleen meridians, and has the effects of tonifying qi, ascending yang, consolidating the exterior to stop sweating, promoting water metabolism, and so on. Radix Astragali contains polysaccharides, saponins, flavonoids, amino acids, and other chemical components. Radix Astragali has a strong ability to tonify qi. The True Herbal Medicine records that "Radix Astragali has a sweet flavor and warm nature, light quality, yellow skin, and white flesh, so it can enter the lung to tonify qi, the exterior to consolidate, and is the best among the tonifying qi herbs, hence the name of "Yi Qi" (having vigor). " The polysaccharides of Radix Astragali can achieve 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. Radix Astragali polysaccharides can regulate part of the insulin signal in IR skeletal muscle and may become a potential insulin sensitizer for the treatment of T2DM.

[0022] Radix Puerariae: It has a sweet and pungent flavor, cool nature, and can clear heat and toxic material. It enters the spleen, stomach, and lung meridians, and has the effects of relieving the exterior, reducing fever, promoting diuresis, and activating the meridians. The Classic of Materia Medica has the following record: "Diabetes, body heat, vomiting, arthralgia, genital swelling, and detoxification." A large number of pharmacological studies have shown that puerarin and other isoflavones in Radix Puerariae can play a role in reducing blood sugar by increasing glucose uptake and glucose tolerance, improving IR, and protecting pancreatic beta cells. Daidzein can increase the phosphorylation of adenosine-activated protein kinase (AMPK) and the expression of glucose transporter 4 (GLUT4), and promote glucose uptake to improve insulin sensitivity. Another study has shown that 3'-hydroxy puerarin can improve IR in adipocytes by promoting glucose utilization and inhibiting the production of free fatty acids, which may be related to the upregulation of PPARγ gene expression.

[0023] Fried Atractylodes Rhizome: It has a bitter and sweet flavor, warm nature, and can invigorate the spleen and benefit qi, dry dampness, benefit water, and consolidate the exterior to stop sweating. Atractylodes Rhizome polysaccharide compound AMP-B isolated from Atractylodes Rhizome crude polysaccharide has obvious hypoglycemic activity, and its mechanism may be to weaken the damage of alloxan to pancreatic beta cells or improve the function of damaged beta cells. After 6 weeks of intragastric administration of Atractylodes Rhizome volatile oil, the serum of metabolic syndrome rats showed significant improvement in hyperglycemia, hyperinsulinemia, and insulin sensitivity indicators, indicating that Atractylodes Rhizome volatile oil can reduce IR, improve insulin sensitivity, and thus reduce fasting blood glucose (FBG) in rats and effectively improve glucose and lipid metabolism. Some experiments have shown that after continuous administration of Atractylodes Rhizome ethanol extract (AMK), the FBG level of spontaneous type 2 diabetic db / db mice was significantly reduced, the fasting serum insulin level was significantly increased, and the IR was improved, suggesting that AMK may play a role in reducing blood sugar by increasing insulin secretion and promoting the proliferation of pancreatic beta cells.

[0024] Ramulus mori: slightly bitter, neutral, liver meridian, dispel wind and dampness, benefit joints. "Herbal Ready" called Ramulus mori: benefit joints, nourish fluid, water to go to the wind. A large number of studies suggest that the main active ingredient of 1-DNJ in mulberry polyhydroxy alkaloids is the main active ingredient of its hypoglycemic effect, in addition, the alcohol extract of Ramulus mori can promote insulin secretion and sensitivity, and the flavonoids in Ramulus mori morusin, quercetin, sanggenon C, kuwanon G also have certain inhibitory activity of α-glucosidase, indicating that other non-polyhydroxy alkaloids in Ramulus mori also have hypoglycemic effect.

[0025] Salvia miltiorrhiza: first recorded in "Shennong's Herbal Classic", listed as the top product, bitter, slightly cold, heart and liver meridian, bitter can disperse, slightly cold can clear, both activating blood and removing blood stasis and unblocking and pain, and clearing heart and blood and removing heat and reducing abscess. Experiments have shown that salvia miltiorrhiza extract can improve glucose metabolism disorder by reducing the level of FBG in mice; Danshensu B can improve endothelial cell and mitochondrial dysfunction induced by diabetes, and improve insulin resistance in ob / ob mice by inhibiting endoplasmic reticulum stress in liver; Danshensu I can improve IR of T2DM db / db mice by reducing the levels of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-α) in insulin receptor substrate-1 (IRS-1), reducing the nuclear translocation of NF-κB and the phosphorylation of serine 307 (Ser307), and regulating the AMPK signaling pathway. The above studies show that reducing insulin levels and increasing insulin sensitivity may be an important common mechanism for salvia miltiorrhiza to play a protective role in diseases induced by glucose metabolism disorder.

[0026] Radix Trichosanthis: sweet, bitter, cold, lung and stomach meridian, can clear heat and drain fire, generate fluid and relieve thirst, reduce swelling and discharge pus. "Compendium of Materia Medica" said: "Radix Trichosanthis, sweet and bitter, acid can generate fluid, so it can relieve thirst and moisten dryness, bitter can reduce fire, sweet does not harm the stomach, the ancients only said its bitter cold, may not have been deeply investigated." Modern pharmacological studies have shown that the main components of Radix Trichosanthis TKL, polysaccharide, total saponins, citrulline, etc. have significant hypoglycemic effect. Using Radix Trichosanthis to give diabetic rats intragastrically can reduce the FBG of rats, showing a dose and time dependent relationship, and no adverse reactions such as abdominal distension, diarrhea and anorexia.

[0027] Radix Dioscoreae: from Tang Dynasty · Hou Ningji "Pharmaceutical Spectrum", sweet, flat, spleen and kidney, nourishing and invigorating, nourishing and invigorating, nourishing and invigorating. Dioscorea polysaccharide can significantly reduce blood glucose, its mechanism may be related to restoring insulin secretion function, improving impaired islet beta cell function and removing excess free radicals, etc., and can also increase insulin sensitivity and improve insulin signal transduction pathway.

[0028] Radix Lablab Albumus: sweet, slightly warm, sweet detoxification, slightly warm and wet, into the spleen and stomach, can not only invigorate the spleen and remove dampness, but also remove dampness and harmonize the center, relieve summer heat and stop diarrhea, and also resolve alcohol toxicity. Research has found that 16 saponin components have been identified from Radix Lablab Albumus, which can mediate disease inflammation, 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 disease development, thereby playing a role in treating diabetes through multi-component and multi-target synergy. The results of the study show that Radix Lablab Albumus polysaccharide can improve the IR level of T2DM rats by regulating blood lipid metabolism and inhibiting hypothalamic-pituitary-adrenal (HPA) axis hyperactivity, thereby playing a hypoglycemic role.

[0029] Fructus Amomi: pungent, warm, spleen, stomach, kidney, can remove dampness, warm the spleen and stop diarrhea, and regulate qi and prevent miscarriage. Studies have found that water extract of Fructus Amomi can reduce blood glucose levels in rats and has a good protective effect on islet beta cells in rats, and can improve the ultrastructure of insulin beta cells to some extent; ethanol extract of Fructus Amomi has glucagon-like peptide-1 (GLP-1) secretion and glycogen phosphorylase a (GPa) inhibition activity; literature reports that semi-oleanane and norsemi-oleanane diterpenes isolated from the roots of Fructus Amomi have α-glucosidase inhibitory activity; eight terpenoids isolated and identified from Fructus Amomi can promote GLP-1 secretion in the mouse small intestine (STC-1) model, have strong inhibitory activity on GPa, and have moderate inhibitory activity on PTP1B.

[0030] Euryale Ferox: sweet and astringent, neutral, spleen and kidney, sweet and astringent, neutral and not biased, mild. It can invigorate the spleen and remove dampness, and also tonify the kidney and astringe the essence, with the advantages of tonifying without greasiness and astringing without dampness, and is used to treat spleen deficiency and chronic diarrhea and kidney deficiency and unstable lower energy. Modern pharmacological studies have confirmed that Euryale Ferox polysaccharide can increase glucose consumption by activating the activity of the phosphatidylinositide 3-kinase (PI3K) / protein kinase B (Akt) signaling pathway in the insulin resistance model of human hepatocellular carcinoma HepG2 cells, and up-regulating the expression of glucose transporter 4 to improve IR. 2β-hydroxy betulinic acid 3β-oleate isolated from Euryale Ferox can significantly reduce the blood glucose and lipid levels of streptozotocin-induced T2DM model rats.

[0031] Silkworm excrement: bitter, can be scattered and moist, warm, return to stomach, spleen, liver, can dispel wind and dampness, and stomach and turbidity, blood circulation. "Name of medical records" clearly proposed its treatment "diabetes", "Ben Cao Qunzhen" records "because of silkworm food and not drink, its food out and gas dry...... dry and see diabetes, get this Xing to moisten it". The main active ingredient of silkworm excrement extract is 1-deoxynojirimycin, which belongs to the alpha-glucosidase inhibitor, mainly inhibits the decomposition of oligosaccharides into glucose, prevents the absorption of starch and other substances in the small intestine, so as to achieve the purpose of reducing blood sugar. Through animal experiment research, it is found that silkworm excrement extract can significantly reduce the blood glucose peak value and the area under the blood glucose curve of normal mice and high sugar mice after loading with sucrose or starch, and make the blood glucose peak value move back.

[0032] Further, the inventors reasonably optimize the components of the above-mentioned traditional Chinese medicine composition, and finally obtain the following technical scheme: the main components of the traditional Chinese medicine composition are as follows in terms of weight parts:

[0033] Radix astragali 30 parts, radix puerariae 20 parts, fried atractylodes 15 parts, mulberry branch 30 parts, salvia miltiorrhiza 12 parts, radix trichosanthis 20 parts, radix dioscoreae 30 parts, white kidney bean 15 parts, amomum villosum 12 parts, gordon euryale seed 12 parts, silkworm excrement 12 parts.

[0034] On the basis of the above-mentioned drug composition, the inventors further provide a preparation method of the above-mentioned traditional Chinese medicine composition, and a use method of the obtained traditional Chinese medicine decoction.

[0035] First, according to the proportion of raw materials, each kind of traditional Chinese medicine is weighed out, then water is added to 3-5 centimeters above the drug surface, soaked for 1.5 hours, boiled with large fire, then simmered with small fire for 40-50 minutes, the drug juice is filtered out for standby, water is added to the drug residue again, to 2-3 centimeters above the drug residue surface, boiled with large fire, then simmered with small fire for 20-30 minutes, the drug juice is filtered out and combined with the previous drug juice to obtain the traditional Chinese medicine decoction.

[0036] Method of taking: 1 dose per day, divided into two times in the morning and evening, 1-2 hours after meal.

[0037] The medicine obtained by the composition and preparation method of the application has very significant effect in clinical application. The inventors have proved through a large number of tests that compared with the commonly used insulin resistance drug metformin for treating diabetes in clinic, the medicine composition of the application has significant effect in reducing blood sugar, improving insulin resistance, relieving clinical symptoms and improving the quality of life of patients. Therefore, the technical scheme of the application has obvious advantages in theory and clinical effect. In actual conditions, the composition of the application can be used together with western medicine (such as metformin).

[0038] In summary, the present application is based on the traditional Chinese medicine theory, combined with the clinical practice process, obtained for the treatment of insulin resistance in diabetes mellitus of traditional Chinese medicine composition, to invigorate the spleen and replenish qi, clear heat and remove dampness, supplement yin and promote yang, make the yin and yang of the spleen, dry and clear heat, make the wet and hot evil, together with the effect of invigorating the spleen and clearing heat and removing dampness, significantly improve the symptoms and signs of insulin resistance in diabetes mellitus, improve the quality of life of patients and other aspects. DETAILED DESCRIPTION

[0039] The present application is not limited by the following examples, the following examples and descriptions described in the specification are only to illustrate the principles of the present application, without departing from the spirit and scope of the present application, the present application will have various changes and improvements, these changes and improvements all fall within the scope of the claimed present application.

[0040] Example 1

[0041] A kind of traditional Chinese medicine composition for treating insulin resistance in diabetes mellitus, which is prepared from the following drugs:

[0042] Radix Astragali 30g, Pueraria 20g, Fried Atractylodes 15g, Mulberry Twig 30g, Salvia 12g, Radix Trichosanthis 20g, Chinese Yam 30g, White Lentil 15g, Amomum 12g, Gorgon 12g, Silkworm Dung 12g.

[0043] Its preparation method is as follows:

[0044] (1) first, according to the proportion of raw materials, each kind of traditional Chinese medicine is weighed and mixed uniformly, and cold water is added to 3-5 centimeters above the drug surface, and soaked for 1.5 hours;

[0045] (2) the mixed raw materials are boiled with a large fire, and the filtrate and residue are obtained by filtering with gauze after being decocted for 45 minutes;

[0046] (3) the residue obtained in step (2) is added with hot water to 2-3 centimeters above the drug surface, and then mixed and decocted, the hot water is pure water with a temperature of 80℃, boiled with a large fire, and then filtered with gauze after being decocted for 25 minutes to obtain the filtrate and residue;

[0047] (4) the filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed, and the traditional Chinese medicine decoction for treating insulin resistance in diabetes mellitus is obtained.

[0048] Example 2

[0049] A kind of traditional Chinese medicine composition for treating insulin resistance in diabetes mellitus, which is prepared from the following drugs:

[0050] Radix Astragali 20g, Pueraria 15g, Fried Atractylodes 12g, Mulberry Twig 20g, Salvia 9g, Radix Trichosanthis 15g, Chinese Yam 20g, White Lentil 12g, Amomum 9g, Gorgon 9g, Silkworm Dung 9g.

[0051] The preparation method is as follows:

[0052] (1) First, weigh each taste of traditional Chinese medicine according to the proportion of raw materials, mix evenly, add cold water to 3-5 centimeters above the drug surface, soak for 1.5 hours;

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

[0054] (3) Add hot water to the dregs obtained in step (2) to 2-3 centimeters above the drug surface, mix and decoct, the hot water is pure water with a temperature of 80℃, boil with high heat, simmer for 20 minutes with low heat, filter again with gauze to obtain filtrate and dregs;

[0055] (4) Mix the filtrate obtained in step (2) and the filtrate obtained in step (3), and the traditional Chinese medicine decoction for treating insulin resistance of diabetes is obtained.

[0056] Example 3

[0057] A traditional Chinese medicine composition for treating insulin resistance of diabetes is prepared from the following drugs:

[0058] Radix astragali 40g, radix puerariae 25g, fried atractylodes 18g, ramulus mori 40g, salvia miltiorrhiza 15g, radix bupleuri 25g, radix dioscoreae 40g, radix lablab 18g, fructus amomi 15g, semen euryales 15g, silkworm excrement 15g.

[0059] The preparation method is as follows:

[0060] (1) First, weigh each taste of traditional Chinese medicine according to the proportion of raw materials, mix evenly, add cold water to 3-5 centimeters above the drug surface, soak for 1.5 hours;

[0061] (2) Boil the mixed raw materials with high heat, simmer for 40 minutes with low heat, filter with gauze to obtain filtrate and dregs;

[0062] (3) Add hot water to the dregs obtained in step (2) to 2-3 centimeters above the drug surface, mix and decoct, the hot water is pure water with a temperature of 80℃, boil with high heat, simmer for 20 minutes with low heat, filter again with gauze to obtain filtrate and dregs;

[0063] (4) Mix the filtrate obtained in step (2) and the filtrate obtained in step (3), and the traditional Chinese medicine decoction for treating insulin resistance of diabetes is obtained.

[0064] Experimental example

[0065] 1. Clinical data

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

[0067] Study selection: 60 patients with insulin resistance and TCM syndrome diagnosis were selected. The case data came from the outpatients and inpatients 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 Diabetes diagnostic criteria:

[0071] According to the diagnostic criteria for diabetes in the China Type 2 Diabetes Prevention Guidelines (2020 Edition), patients with typical symptoms of diabetes (polydipsia, polyphagia, polyuria, and 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 ≥11.1 mmol / L;

[0075] (4) Or glycosylated hemoglobin HbA1c ≥6.5%.

[0076] Note: Random blood sugar refers to blood sugar at any time of the day without considering the last meal time, which cannot be used to diagnose impaired fasting glucose or impaired glucose tolerance; fasting state refers to at least 8 hours without eating calories; if there are no typical symptoms of diabetes, the test should be repeated on another day for confirmation.

[0077] 1.2.1.2 Insulin resistance diagnostic criteria

[0078] According to the Expert Guidelines for Assessment Methods and Applications of Insulin Resistance published by the Chinese Medical Association Diabetes Branch and Insulin Resistance Assessment and Its Clinical Applications, the insulin resistance index (HOMA-IR) = FPG (mmol / L) x FINS (μU / mL) / 22.5 ≥2.69 is used as the inclusion criterion.

[0079] 1.2.2 TCM syndrome diagnostic criteria

[0080] Reference: TCM Clinical Diagnosis and Treatment Terms Syndrome Part published by the State Technology Supervision Bureau of the People's Republic of China in 1997 and the 2016 edition of the Clinical Evidence-based Practice Guidelines for Diabetes in Traditional Chinese Medicine:

[0081] Main symptoms: ①Food is less; ②Chest and abdominal distension; ③Head and body are heavy.

[0082] Sub-symptoms: ④ fatigue; ⑤ loose or sticky stool.

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

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

[0085] 1.3 Case selection criteria

[0086] 1.3.1 Inclusion criteria

[0087] ① Meet the Western medicine diagnostic criteria for diabetes;

[0088] ② Meet the Chinese medicine diagnosis and syndrome differentiation type of spleen deficiency and dampness-heat type;

[0089] ③ Age between 18-70 years old, gender unrestricted;

[0090] ④ Voluntarily join this trial, can cooperate with treatment and examination, and sign the informed consent form.

[0091] 1.3.2 Exclusion criteria

[0092] ① 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, digestive system diseases;

[0096] ⑤ Pregnant or lactating women;

[0097] ⑥ Allergic constitution and drug allergy;

[0098] ⑦ Do not cooperate and have mental or psychological diseases;

[0099] ⑧ Patients who have experienced severe gastrointestinal reactions after taking metformin in the past.

[0100] 1.3.3 Drop-out criteria

[0101] Patients who meet the inclusion criteria after informed consent, due to adverse reactions, ineffective treatment, loss of follow-up, voluntary withdrawal, poor compliance, etc. do not complete the treatment course and observation period of this program, are drop-out cases.

[0102] 1.3.4 Exclusion criteria

[0103] Patients who affect the clinical efficacy and safety evaluation due to not taking medicine as prescribed, using other drugs privately, and patients who develop severe acute complications such as ketosis and acidosis after treatment are all excluded cases.

[0104] 2. Research method

[0105] 2.1 Study design

[0106] 60 patients who met the diagnostic criteria for insulin resistance in patients with diabetes and were diagnosed as having spleen deficiency and dampness-heat were selected, and they were randomly divided into the test group and the control group by using the random number table method, with 30 patients in each group. The clinical efficacy was observed by comparing the implementation of Example 1 drug composition treatment (applying the process and dosage of Example 1 to decoct 200 ml of traditional Chinese medicine decoction, taking 100 ml twice a day) and metformin. The treatment course was 8 weeks, and the changes in the quantitative scores of TCM syndromes and experimental value indexes of the patients in the two groups before and after treatment were observed. After the treatment course, all the data were statistically analyzed and processed by using statistical software SPSS 27.0, 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 method

[0108] 2.2.1 Basic treatment

[0109] ①Diabetes self-management education;

[0110] ②Diet control: according to the China Type 2 Diabetes Prevention Guidelines (2020 Edition), the energy intake is calculated according to 105-126 KJ (25-30 kcal)·kg -1 (standard body weight)·d -1 For overweight or obese diabetic patients, the total energy intake should be controlled, and the eating habits should be adjusted to lose at least 5% of the body weight.

[0111] ③Moderate exercise: at least 150 minutes of moderate-intensity aerobic exercise per week. Such as Taijiquan, cycling, walking, swimming, ball games, bodybuilding, resistance exercise, etc., develop an exercise plan according to their own situation and bearing capacity.

[0112] 2.2.2 Group treatment

[0113] ①Test group: taking the drug composition of Example 1 for treatment (applying the process and dosage of Example 1 to decoct 200 ml of liquid medicine, taking 100 ml twice a day).

[0114] ②Control group: taking metformin hydrochloride tablets (Gewuzhi, specification: 0.5 g / tablet, GMP H20023370, produced by Shanghai Schering-Plough Pharmaceuticals Co., Ltd.), 0.5 g each time, 3 times a day, taken orally before meals.

[0115] The observation time of the test group and the control group is 8 weeks, and then regular follow-up is conducted to understand the improvement of subjective symptoms, laboratory examination and record the adverse reactions before and after treatment.

[0116] 2.3 Observation index

[0117] 2.3.1 Safety index

[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, each examination once before and after treatment;

[0120] ③ Close observation of patients for adverse reactions.

[0121] 2.3.2 Efficacy index

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

[0123] ② Fasting insulin (FINS), glycosylated hemoglobin (HbA1c), total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) were examined and recorded once before and after treatment; insulin resistance index (HOMA-IR), pancreatic beta cell function index (HOMA-β) were calculated once before and after treatment;

[0124] Note: IR is evaluated by insulin resistance index (HOMA-IR) and pancreatic beta cell function index (HOMA-β). The calculation formula is: HOMA-IR = FPG × FINS / 22.5; HOMA-β = 20 × FINS / (FPG-3.5)

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

[0126] 2.4 Efficacy evaluation criteria

[0127] 2.4.1 TCM syndrome efficacy evaluation criteria

[0128] According to the changes of clinical symptoms and signs, the standard is formulated as follows according to the Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine:

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

[0130] (1) Marked effect: TCM clinical symptoms and signs improved significantly, syndrome score decreased ≥70%;

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

[0132] (3) Ineffective: There is no significant improvement in the clinical symptoms and signs of TCM, or even aggravation, and the syndrome score decreases by <30%.

[0133] 2.4.2 Criteria for Judging Blood Glucose Efficacy

[0134] Significant effect: FPG and 2hPG decreased to the normal range, or decreased by more than 40% of the pre-treatment level; HbA1c level decreased to the normal range, or decreased by more than 30% of the pre-treatment level;

[0135] Effective: FPG and 2hPG decreased by more than 20% from the pre-treatment level, but did not meet the criteria for marked efficacy; HbA1c decreased by more than 10% from the pre-treatment level, but did not meet the criteria for marked efficacy.

[0136] Invalid: FPG and 2hPG did not decrease, or the decrease did not meet the valid criteria; HbA1c did not decrease, or the decrease did not meet the valid criteria.

[0137] 2.5 Statistical Methods

[0138] Statistical analysis was conducted using an Excel database and SPSS 27.0 statistical software. Data were assumed to follow a normal distribution, and measurement data were expressed as mean ± standard deviation. For descriptions, if homogeneity of variance is met, a t-test is used; if homogeneity of variance is not met, an approximate t-test is used. Count data are described as rates (%) and expressed using chi-square (χ²). 2 For ordinal data and data that do not conform to a normal distribution, the median and interquartile range are used for description, and the nonparametric rank-sum test is used. All statistical methods are two-tailed tests, and a p-value < 0.05 is considered statistically significant.

[0139] 3. Results and Analysis

[0140] 3.1 General Information

[0141] All patients were admitted to the Department of Endocrinology at the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from September 2021 to December 2023, totaling 60 cases (n). There were 30 patients in the experimental group and 30 in the control group. No cases dropped out during the treatment process in either group. In the experimental group, there were 17 males and 13 females, with a mean age of (48.32±11.55) years; in the control group, there were 14 males and 16 females, with a mean age of (51.49±9.00) years. There were no statistically significant differences between the two groups before treatment in terms of gender (P=0.438), age (P=0.779), and disease duration (P=0.476) (P>0.05), making them comparable (see Tables 1, 2, and 3).

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

[0143]

[0144] Note: by χ 2 Test, P=0.438>0.05, no statistically significant difference in gender, can be compared.

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

[0146]

[0147] Note: by independent sample t test, P=0.799>0.05, no statistically significant difference in age, can be compared.

[0148] Table 3 Comparison of disease duration of two groups of patients

[0149]

[0150] Note: by independent sample t test, P=0.476>0.05, no statistically significant difference in disease duration, can be compared.

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

[0152] 3.2.1 Comparison of blood glucose of two groups of patients before and after treatment (Table 4)

[0153] Table 4 Comparison of blood glucose indicators of two groups of patients before and after treatment

[0154]

[0155]

[0156] Test, before treatment, FPG, 2hPG, HbA1c between groups, P>0.05, no statistically significant difference, with comparability. After treatment, FPG, 2hPG, HbA1c of two groups were lower than before treatment, P<0.01, the difference was statistically significant, indicating that the test group and the control group can significantly reduce FPG, 2hPG, HbA1c. After treatment, 2hPG(P=0.002<0.01) had significant difference, HbA1c(P=0.017<0.05) had significant difference, indicating that the test group reduced 2hPG, HbA1c effect more obvious; FPG(P=0.097>0.05) had no significant difference.

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

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

[0159]

[0160] After treatment, TG, TC and LDL-C of both groups were decreased compared with those before treatment. TG and TC of the test group and TC of the control group were significantly decreased (P<0.01), LDL-C of the test group and TG and LDL-C of the control group were decreased (P<0.05), which indicated that both groups could decrease TG, TC and LDL-C. TG (P=0.007<0.01) and TC (P=0.001<0.01) were significantly different between the two groups after treatment, which indicated that the test group was more effective in decreasing TG and TC.

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

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

[0163]

[0164] After treatment, FINS and HOMA-IR of both groups were decreased compared with those before treatment, and HOMA-β was increased. HOMA-IR and HOMA-β of both groups and FINS of the test group were significantly decreased (P<0.01), and FINS of the control group was not significantly different (P=0.065>0.05), which indicated that both groups could significantly decrease HOMA-IR and increase HOMA-β, and the test group could also significantly decrease FINS. FINS (P=0.037<0.05) and HOMA-IR (P=0.038<0.05) were significantly different between the two groups after treatment, and HOMA-β was not significantly different (P=0.751>0.05).

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

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

[0167]

[0168] The inspection, before treatment, two groups of TCM syndrome score between groups, P> 0.05, the difference was not statistically significant, with comparable. After treatment, the two groups of TCM syndrome score were improved, P<0.01, the difference was statistically significant, indicating that the test group and the control group can significantly improve the clinical symptoms of TCM. After treatment, the comparison between groups, P<0.01, the difference was statistically significant, indicating that the test group improved the clinical symptoms of TCM effect more obvious.

[0169] 3.2.5 Comparison of TCM syndrome 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: by rank sum test, Z=-2.175, P=0.03<0.05, the difference was statistically significant.

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

[0174] Table 9 Comparison of clinical recurrence rate

[0175]

[0176] Note: 4 weeks after the end of treatment, 4 people in the test group relapsed, the recurrence rate was 13.33%, 14 people in the control group relapsed, the recurrence rate was 46.66%, the difference was statistically significant (P<0.01).

[0177] 3.4 Safety analysis

[0178] No serious adverse reactions were reported in the two groups during the trial period, and no obvious abnormalities were found in the indicators, indicating that the drug used in this trial was safe.

[0179] Specific cases

[0180] Case 1

[0181] Li, male, 42 years old, diagnosed on July 2, 2022. Complaint: found elevated blood glucose for more than 3 years. The patient found elevated blood glucose in a local hospital 3 years ago, with a fasting blood glucose of up to 12.6 mmol / L. Regular oral metformin treatment controlled fasting blood glucose at 6-7 mmol / L. The patient has not controlled diet and exercised too little. Now the blood glucose is not well controlled, with fasting blood glucose fluctuating between 11-12 mmol / L. Therefore, the patient came to Professor Xu's clinic for treatment. Present symptoms: listless and weak, sticky mouth, thirsty but not willing to drink, poor appetite, postprandial epigastric distention, good sleep, regular urination, and loose stool once a day. Pale tongue with tooth marks on the edge and yellow and greasy fur, and slippery and rapid pulse. Test: FPG 9.5 mmol / L, 2hPG 13.1 mmol / L, HbA1c 8.3%, TG 2.54 mmol / L, TC 5.76 mmol / L, LDL-C 3.52 mmol / L, FINS 18.04 μU / mL, HOMA-IR 7.62, HOMA-β 60.13. Western medical diagnosis: diabetes and insulin resistance; TCM diagnosis: diabetes, spleen deficiency and dampness. Treatment: tonifying qi and spleen, clearing heat and dampness. Prescription: Huangqi 30g, Gegen 20g, Fried Baishu 15g, Sangzhi 15g, Danshen 12g, Tianhuafen 20g, Shanyao 30g, Baibiandou 15g, Sharen 12g, Qianshili 12g, and silkworm excrement 12g. The decoction was prepared according to the preparation method of Example 1, 200ml of which was taken twice a day, 100ml each time, for 14 days.

[0182] Divide into morning and evening, 100ml each time, for 14 days;

[0183] Re-examination on July 16, 2022: The patient felt less listless and weak, and the other symptoms had no obvious changes. Good sleep, regular urination, pale tongue with tooth marks on the edge, and white and greasy fur. Test: FPG 8.7 mmol / L. Continue taking the above prescription, for 28 days.

[0184] Re-examination on August 13, 2022: The patient reported that listless and weak was significantly reduced, and thirst was relieved. Good sleep, regular urination, pale red tongue, thin white fur, and slippery pulse. Test: FPG 7.4 mmol / L. Continue taking the above prescription, for 14 days.

[0185] Re-examination on August 27, 2022: The patient reported that all symptoms were reduced or disappeared. Good sleep, regular urination, pale red tongue, thin white fur, and slippery pulse. Test: FPG 6.8 mmol / L, 2hPG 9.1 mmol / L, HbA1c 7.1%, TG 1.92 mmol / L, TC 4.32 mmol / L, LDL-C 2.95 mmol / L, FINS 14.25 μU / mL, HOMA-IR 4.31, and HOMA-β 86.36.

[0186] Case 2

[0187] Mr. Bai, male, 48 years old, first visit on April 30, 2023. Chief complaint: Elevated blood glucose for 8 years. Present illness: The patient's fasting plasma glucose (FPG) was measured at 9.1 mmol / L during a physical examination 8 years ago, and subsequent fasting blood glucose measurements have consistently been >

[0188] The patient's blood glucose level was 6.1 mmol / L, diagnosed as "type 2 diabetes." The highest recorded blood glucose level was 13 mmol / L. The patient had previously taken metformin and other medications as prescribed, but with little effect. Therefore, the patient sought treatment at the Department of Endocrinology, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. Current symptoms include: dry mouth without thirst, fatigue, abdominal distension, poor appetite, normal sleep, frequent flatulence, sticky stools (twice a day), and normal urination. The tongue is pale red with a yellow, greasy coating, enlarged body, and teeth marks on the edges. The pulse is deep and thready. Examination revealed: Fasting plasma glucose (FPG) 10.3 mmol / L, 2-hour postprandial glucose (2hPG) 14.5 mmol / L, HbA1c 9.7%, triglycerides (TG) 2.62 mmol / L, total cholesterol (TC) 5.84 mmol / L, LDL-C 3.51 mmol / L, fresh blood glucose (FINS) 19.11 μU / mL, HOMA-IR 8.75, and HOMA-β 56.21. Western medicine diagnosis: Diabetes mellitus with insulin resistance; Traditional Chinese medicine diagnosis: Diabetes mellitus with spleen deficiency and damp-heat syndrome. Treatment principle: Tonify Qi and strengthen the spleen, clear heat and resolve dampness. Prescription: Astragalus membranaceus 30g, Pueraria lobata 20g, stir-fried Atractylodes macrocephala 15g, Morus alba twig 15g, Salvia miltiorrhiza 12g, Trichosanthes kirilowii 20g, Dioscorea opposita 30g, Dolichos lablab 15g, Amomum villosum 12g, Euryale ferox 12g, Bombyx mori excrement 12g. The decoction of the Chinese herbs prepared according to the method in Example 1 is used. One dose of 200ml is taken daily, divided into two warm doses of 100ml each, morning and evening, for 14 doses.

[0189] Follow-up visit on May 14, 2023: The patient reported that dry mouth, abdominal distension, and poor appetite had improved compared to before, but still felt weak. The tongue was pale red with a thin white coating, enlarged, and had teeth marks on the edges. The pulse was deep and thready. Examination revealed an FPG level of 9.5 mmol / L. The above prescription was continued for 28 doses.

[0190] Follow-up visit on May 11, 2023: Fatigue significantly improved compared to before, occasional lower back pain, pale red tongue with thin white coating, enlarged tongue body, deep and thready pulse, examination: FPG 8.3 mmol / L. Continue taking the above prescription for 14 doses;

[0191] Follow-up visit on May 25, 2023: The patient reported no significant discomfort. Tongue was pale red with a thin white coating, and pulse was thready. Examination revealed: FPG 7.1 mmol / L, 2hPG 9.8 mmol / L, HbA1c 7.8%, TG 1.98 mmol / L, TC 4.25 mmol / L, LDL-C 2.58 mmol / L, FINS 15.02 μU / mL, HOMA-IR 4.74, HOMA-β 83.44.

[0192] The above merely describes the preferred embodiments of the present application and is not used to limit the present application, and any equivalent replacement, modification, etc. made by those skilled in the art within the spirit and principle of the present application without any creative labor should be included in the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating insulin resistance of diabetes, characterized in that: Its components are calculated by weight parts: 20-40 parts of Huangqi, 15-25 parts of Gegen, 12-18 parts of fried Baizhu, 20-40 parts of Sangzhi, 9-15 parts of Danshen, 15-25 parts of Tianfen, 20-40 parts of Shanyao, 12-18 parts of Bai Douchi, 9-15 parts of Sharen, 9-15 parts of Biejie, 9-15 parts of Cansha. ​ 2. The Chinese medicine composition for treating insulin resistance of diabetes according to claim 1, characterized in that: Its components are calculated by weight parts: 21-39 parts of Huangqi, 16-24 parts of Gegen, 13-17 parts of fried Baizhu, 21-39 parts of Sangzhi, 10-14 parts of Danshen, 16-24 parts of Tianfen, 21-39 parts of Shanyao, 13-17 parts of Bai Douchi, 10-14 parts of Sharen, 10-14 parts of Biejie, 10-14 parts of Cansha.

3. The Chinese medicine composition for treating insulin resistance of diabetes according to claim 2, characterized in that: Its components are calculated by weight parts: 30 parts of Huangqi, 20 parts of Gegen, 15 parts of fried Baizhu, 30 parts of Sangzhi, 12 parts of Danshen, 20 parts of Tianfen, 30 parts of Shanyao, 15 parts of Bai Douchi, 12 parts of Sharen, 12 parts of Biejie, 12 parts of Cansha.

4. The method for preparing the traditional Chinese medicine composition for treating insulin resistance of diabetes of claim 1, characterized in that, The specific steps are as follows: first, according to the proportion of raw materials, each flavor of traditional Chinese medicine is weighed, then water is added to cover the medicine surface by 3-5 centimeters, soaked for 1.5 hours, boiled with large fire, then simmered with small fire for 40-50 minutes, the filtrate is reserved, water is added to the residue, cover the medicine surface by 2-3 centimeters, boiled with large fire, then simmered with small fire for 20-30 minutes, the filtrate is combined with the above filtrate to obtain the filtrate.

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