Traditional Chinese medicine composition for treating type 2 diabetes mellitus as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition for treating type 2 diabetes and a preparation method and application thereof. The traditional Chinese medicine composition for treating the type 2 diabetes mellitus comprises radix astragali preparata, rhizoma coptidis, cortex phellodendri, rhizoma atractylodis, radix achyranthis bidentatae, fried semen coicis and semen plantaginis, qi-tonifying and spleen-tonifying medicines and heat-clearing and diuresis-promoting medicines are matched in the traditional Chinese medicine composition, so that the traditional Chinese medicine composition has the functions of tonifying qi, clearing heat and eliminating dampness and has the effects of tonifying qi, clearing heat and eliminating dampness; the traditional Chinese medicine composition has obvious curative effects on improving type 2 diabetes symptoms, improving life quality of patients, improving long-term prognosis and the like.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for treating type 2 diabetes, and a preparation method and application thereof. Background Art

[0002] Type 2 diabetes mellitus (T2DM) is a common and frequently occurring clinical disease. Its pathogenesis is closely linked to multiple factors, including genetic susceptibility, environmental exposures, and autoimmunity, ultimately leading to impaired insulin secretion and utilization, and consequently, glucose metabolism disorders. According to the International Diabetes Federation (IDF), the number of adults aged 20-79 years worldwide with diabetes has reached 537 million (prevalence rate 10.5%), and is projected to increase to 643 million (11.3%) and 783 million (12.2%) by 2030 and 2045, respectively. T2DM not only causes severe glucose metabolism disorders but also significantly increases the risk of complications such as cardiovascular disease, chronic kidney disease, and retinopathy, posing multiple challenges to global public health systems.

[0003] The pathophysiological mechanisms of type 2 diabetes (T2DM) remain incompletely understood. Genetic susceptibility, gut microbiome disturbances, autoimmunity, and insulin resistance (IR) and β-cell failure are key components of the disease. IR is a key mechanism in the development of T2DM, and its formation is closely linked to genetic factors. Modern lifestyle changes (such as a high-calorie diet and lack of exercise) can lead to obesity, which in turn induces IR in peripheral tissues. Pancreatic β-cell dysfunction is also a key pathogenesis of T2DM. Under the long-term effects of obesity and IR, pancreatic β-cells undergo compensatory proliferation and hypertrophy, ultimately leading to apoptosis and a progressive decline in pancreatic secretory function. Furthermore, chronic low-grade inflammation plays a key role in the development of T2DM. Adipose tissue in obese patients secretes a variety of inflammatory cytokines (such as TNF-α and IL-6), which interfere with insulin signaling. Furthermore, T2DM exhibits a strong familial clustering pattern, and studies have shown that multiple genetic loci are associated with the risk of developing T2DM.

[0004] Currently, Western medications used to treat T2DM primarily include oral hypoglycemic drugs and insulin preparations. Oral hypoglycemic drugs primarily work by improving insulin resistance (such as metformin and thiazolidinediones) and promoting insulin secretion (such as sulfonylureas and glinides). While they can effectively control blood sugar, they are often associated with adverse reactions such as gastrointestinal reactions and the risk of hypoglycemia, which limits treatment compliance in some patients.

[0005] In Traditional Chinese Medicine (TCM), T2DM is classified as a disease of "xiaoke" (disease with thirst) or "pixian" (spleen deficiency) based on its typical symptoms and characteristics. TCM has a long history of treating diabetes, and its intervention for T2DM focuses on a holistic approach, leveraging multi-target, multi-level, and comprehensive therapeutic approaches through regulating visceral function, harmonizing qi, blood, yin, and yang, and dredging meridians. The core pathogenesis of T2DM revolves around the evolution of "yin deficiency and dryness-qi and yin deficiency-yin and yang deficiency," and treatment focuses on clearing heat and moistening dryness, invigorating qi and nourishing yin, and warming yang and transforming dampness. Numerous studies have confirmed the remarkable effectiveness of TCM in lowering blood sugar, increasing insulin sensitivity, and improving pancreatic beta-cell function. It also boasts minimal side effects, proven efficacy, and ease of adoption, all of which can reduce the financial burden on patients.

[0006] However, Traditional Chinese Medicine (TCM) still lacks a unified and mature treatment plan for the prevention and treatment of T2DM, and treatment effectiveness needs to be improved. Currently, some TCM compound formulas have been used clinically, and while they have a certain auxiliary effect on blood sugar control, they are still not ideal in correcting insulin secretion disorders and improving glucose and lipid metabolism. Summary of the Invention

[0007] The purpose of this application is to provide a traditional Chinese medicine composition for treating type 2 diabetes, and its preparation method and application, so as to solve the problem that existing traditional Chinese medicine has poor efficacy in the prevention and treatment of T2DM.

[0008] In order to achieve the above-mentioned invention objectives, the technical solutions adopted in this application are:

[0009] In a first aspect, the present application provides a traditional Chinese medicine composition for treating type 2 diabetes, comprising the following components:

[0010] Roasted Astragalus, Coptis chinensis, Phellodendron amurense, Atractylodes lancea, Achyranthes bidentata, stir-fried Coix seed, Plantago seed.

[0011] In an optional embodiment, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0012] 20-40 parts of roasted Astragalus, 4-10 parts of Coptis chinensis, 4-20 parts of Phellodendron amurense, 5-20 parts of Atractylodes lancea, 20-40 parts of Polygonum multiflorum, 10-30 parts of stir-fried Coix seeds, and 20-40 parts of Plantago seeds.

[0013] In an optional embodiment, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0014] 26-34 parts of roasted Astragalus, 4-9 parts of Coptis chinensis, 4-14 parts of Phellodendron amurense, 6-14 parts of Atractylodes lancea, 25-35 parts of Polygonum multiflorum, 15-25 parts of stir-fried Coix seeds, and 25-35 parts of Plantago seeds.

[0015] In an optional embodiment, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0016] 30 parts of roasted Astragalus, 5 parts of Coptis chinensis, 10 parts of Phellodendron amurense, 9 parts of Atractylodes macrocephala, 30 parts of Rhizoma Cyathulae, 20 parts of stir-fried Coix seeds, and 30 parts of Plantago seeds.

[0017] In a second aspect, the present application provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0018] Weigh the prescribed amount of each Chinese medicine, decoct them, and take the medicinal juice.

[0019] In an optional embodiment, the preparation method comprises the following steps:

[0020] Weigh the prescribed amount of each Chinese medicine, mix them, add water to cover the medicine surface by 3 to 5 cm, soak for 1.5 to 2 hours, boil over high heat, then simmer over low heat for 40 to 50 minutes, separate the solid and liquid, and obtain a first medicinal juice and a first medicinal residue;

[0021] Add water to the first medicinal residue again, covering the surface of the medicinal residue by 1 to 2 cm, boil over high heat, and then simmer over low heat for 20 to 30 minutes to separate the solid and liquid to obtain the second medicinal juice;

[0022] The first and second concoctions are combined.

[0023] In a third aspect, the present application provides a drug for treating type 2 diabetes, wherein the raw materials of the drug include the above-mentioned traditional Chinese medicine composition.

[0024] In an optional embodiment, the drug further comprises a pharmaceutically acceptable excipient.

[0025] In an optional embodiment, the dosage form of the drug includes an oral preparation or an injection preparation;

[0026] The oral preparations include tablets, capsules, granules, pills, syrups, oral solutions, oral suspensions or oral emulsions;

[0027] The injection preparation includes injection solution or powder injection.

[0028] In a fourth aspect, the present application provides the use of the above-mentioned Chinese medicine composition or medicine in the preparation of a product for treating type 2 diabetes.

[0029] Based on the above technical solution, this application has at least the following beneficial effects:

[0030] The traditional Chinese medicine composition provided in the present application for treating type 2 diabetes comprises roasted astragalus root, coptis root, phellodendron amurense, atractylodes lancea, radix polygoni multiflori, stir-fried coix seed, and plantago seed. The traditional Chinese medicine composition uses qi-invigorating and spleen-strengthening drugs in combination with heat-clearing and dampness-eliminating drugs, which nourishes without being greasy, clears heat without damaging the body, and removes both dampness and heat, achieving the functions of invigorating qi, clearing heat and removing dampness, and having a significant therapeutic effect on improving the symptoms of type 2 diabetes, enhancing the quality of life of patients, and improving the long-term prognosis. DETAILED DESCRIPTION

[0031] To further illustrate the technical means and results employed by this application to achieve the intended invention objectives, the following describes in detail the specific implementation methods, technical solutions, and features of this application using preferred embodiments. The specific features, structures, or characteristics of the various embodiments described below may be combined in any suitable manner.

[0032] If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in this field can be used. If the manufacturer of the reagents or instruments is not specified, they are all commercially available conventional reagents.

[0033] Currently, there is a lack of effective treatment options for T2DM in the field of traditional Chinese medicine, and traditional Chinese medicine compound prescriptions are still unable to effectively correct insulin secretion disorders and comprehensively improve the clinical symptoms of T2DM. In response to this situation, this application innovatively proposes a traditional Chinese medicine composition for treating T2DM and its preparation method. The traditional Chinese medicine composition is composed of herbs such as Astragalus, Coptis chinensis, Phellodendron amurense, Atractylodes macrocephala, Achyranthes bidentata, Coix seed, and Plantago seed. It combines spleen-tonifying and qi-invigorating herbs with heat-clearing and dampness-removing herbs to achieve a tonifying effect without being greasy, and heat-clearing without damaging the body. The combined effects of strengthening the spleen and qi, clearing heat and removing dampness, and the composition are significantly effective in improving the symptoms and signs of T2DM patients and enhancing their quality of life.

[0034] Traditional Chinese Medicine (TCM) believes that diabetes mellitus may be caused by emotional distress or long-term dietary imbalances, leading to dysfunctional spleen function and disrupted qi, blood, and body fluid transport. This leads to accumulation in the internal organs and meridians, which in turn transforms into heat, causing damp-heat to accumulate within the spleen and stomach, blocking the middle burner. Dampness depletes qi, while heat damages yin. Therefore, over time, diabetes mellitus depletes qi and yin, often manifesting as both qi and yin deficiency. Numerous clinical studies have also demonstrated that qi and yin deficiency and damp-heat in the spleen and stomach are the predominant TCM syndromes in the early, middle, and late stages of diabetes mellitus. In addition to poor blood sugar control, these patients often experience abdominal distension, poor appetite, dry and bitter mouth, heaviness and fatigue, restlessness, thirst, nausea and vomiting, yellow and foul-smelling stools, short, dark urine, a red tongue with a yellow, greasy coating, and a slippery and rapid pulse, reflecting the underlying pathogenesis of qi deficiency and the secondary damp-heat.

[0035] The formula of this application is derived from the Four Wonders Powder (Atractylodes macrocephala, Phellodendron chinense, Achyranthes bidentata, Coix seed) in Cheng Fang Du, a book written by Zhang Bingcheng, a physician in the Qing Dynasty. Based on the core pathogenesis of T2DM and his own rich clinical experience in medication, the inventor cleverly modified the traditional Four Wonders Pills and innovatively added three herbs: Astragalus membranaceus, Coptis chinensis, and Plantago seed to create the Astragalus Four Wonders Decoction for the treatment of invigorating qi, clearing heat, removing dampness, and detoxifying: Astragalus membranaceus is the main herb, which greatly replenishes the qi of the spleen and lungs and supports the source of qi and blood biochemical metabolism; Coptis chinensis is used to clear damp-heat in the middle burner, Phellodendron chinense purges hidden fire in the lower burner, and Atractylodes macrocephala dries dampness in the spleen and promotes metabolism. The combination of these three herbs not only helps Astragalus membranaceus to invigorate qi and strengthen the spleen to cut off the source of dampness, but also directly clears the damp-heat that has already formed; Coix seed and Plantago seed are used as adjuvants to remove dampness and heat, benefit the tendons and meridians, and enhance the effect of clearing heat and removing dampness; Achyranthes bidentata is used to guide the herbs downward to replenish the liver and kidneys and strengthen the tendons and bones. The combined effects of these herbs strengthen the spleen and replenish qi, clear away heat and dampness, and detoxify and dredge the meridians, addressing the core pathological link of qi deficiency and dampness-heat in T2DM. Years of clinical application and observation have shown that this prescription effectively lowers blood sugar levels, improves IR, and delays the development of T2DM complications, with a proven safety profile.

[0036] In summary, this application focuses on strengthening the spleen and stomach. By synergizing spleen and qi with heat-clearing and dampness-removing, it restores the middle jiao's function of raising clearness and lowering turbidity, thereby replenishing qi and blood, regulating qi flow, and eliminating pathological products such as dampness, heat toxins, and blood stasis. This effectively improves patients' blood sugar levels and blocks the development of diabetes and its complications. This innovative therapeutic mechanism has been verified by the inventors and has been successfully applied to specific treatment processes. It has been incorporated into the routine diagnosis and treatment protocols of the inventors' medical institutions, opening up a new path for the Traditional Chinese Medicine treatment of T2DM.

[0037] On the basis of the above-mentioned treatment mechanism and in combination with the action mechanism of relevant drugs, the specific technical solutions provided by this application are as follows:

[0038] A Chinese medicine composition for treating type 2 diabetes, wherein the main components thereof are as follows in dosage:

[0039] 20-40 parts of roasted Astragalus, 4-10 parts of Coptis chinensis, 4-20 parts of Phellodendron amurense, 5-20 parts of Atractylodes macrocephala, 20-40 parts of Achyranthes bidentata, 10-30 parts of stir-fried Coix seeds, and 20-40 parts of Plantago seeds. The above dosage ranges can achieve the best therapeutic effect. Excessive or insufficient dosages will cause the primary and secondary pathogenesis of the prescription to change.

[0040] In the formula, Astragalus is the main medicine, which can replenish the Qi of the spleen and lungs to benefit the source of Qi and blood; Coptis chinensis, Phellodendron amurense, and Atractylodes lancea are the auxiliary medicines. Atractylodes lancea can help Astragalus huangzhi to strengthen the spleen and eliminate the source of dampness, and can also dry up the existing dampness so that the spleen can transport and transform it. Coptis chinensis is good at clearing dampness and heat in the middle burner, and Phellodendron amurense is good at clearing dampness and heat in the lower burner. When combined with Astragalus huangzhi and Atractylodes lancea, the two are cold and the two are warm, and the main and the auxiliary medicines complement each other; Coix seed and Plantago seed are used to eliminate dampness and heat and benefit the tendons and meridians, which can help the main and auxiliary medicines clear heat and eliminate dampness; Achyranthes bidentata is used to nourish the liver and kidneys and lead the power of all the medicines to directly enter the lower burner; all the medicines work together to achieve the effects of invigorating Qi, detoxifying, clearing heat and removing dampness.

[0041] The more specific Chinese and Western medicinal mechanisms for each herb are as follows:

[0042] Astragalus: First mentioned in the "Wu Er Bing Fang" (Five-Two Prescriptions for Treating Diseases), it is slightly warm in nature, sweet in flavor, and enters the lung and spleen meridians. It has multiple benefits, including tonifying qi and raising yang, strengthening the exterior and arresting perspiration, and promoting diuresis and reducing swelling. Astragalus contains polysaccharides, saponins, flavonoids, and amino acids. Its qi-tonifying properties are particularly pronounced. The "Compendium of Materia Medica" states: "Astragalus, with its sweet flavor and warm nature, is light in texture, with yellow skin and white flesh. Therefore, it can enter the lungs to tonify qi and strengthen the exterior and defense, making it the most effective of all qi-tonifying herbs, hence the name 'qi'." Astragalus polysaccharides have been shown to enhance insulin sensitization and lower blood glucose levels by reducing the expression and activity of PTP1B in skeletal muscle of streptozotocin-induced T2DM rats. Astragalus polysaccharides can modulate some insulin signaling in insulin-resistant skeletal muscle and may serve as a potential insulin sensitizer for the treatment of type 2 diabetes.

[0043] Coptis chinensis: Bitter and cold, it enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians, clearing heat and dampness, purging fire and detoxifying. Studies have shown that its components, such as quercetin, palmatine, and berberine, can regulate glucose and lipid metabolism, reduce pro-inflammatory factors, provide antioxidant benefits, upregulate the expression of glucose transporter 4, and elevate insulin levels, thereby promoting cellular glucose uptake and lowering blood sugar.

[0044] Phellodendron chinense: Bitter and cold, it enters the kidney, bladder, and large intestine meridians, and is also effective in clearing heat and dampness, purging fire and detoxifying. The "Compendium of Materia Medica" states that it "mainly treats qi-heat accumulation in the five internal organs and intestines," making it particularly suitable for patients with T2DM characterized by damp-heat in the spleen and stomach. Research has shown that the phellodendron chinense in Phellodendron chinense can protect pancreatic beta cells by combating oxidative stress and scavenging excess free radicals. Furthermore, the phellodendron chinense lactone (Phellodendron chinense) can improve insulin resistance and regulate glucose and lipid metabolism by inhibiting inflammation.

[0045] Atractylodes lancea: Pungent, bitter, and warm, it enters the spleen and stomach meridians, clearing dampness and strengthening the spleen, dispelling wind, and improving eyesight. The Complete Collection of Ancient and Modern Medical Records states that "for diabetes, drinking a decoction of Atractylodes lancea alone can quench thirst." Modern research indicates that atractylodes glycosides can lower blood sugar levels, inhibit glycogenesis, and reduce muscle and liver glycogen storage and oxygen consumption.

[0046] Coix seed: Sweet, light, and slightly cold, it enters the spleen, stomach, and lung meridians. It promotes diuresis, dissipates dampness, strengthens the spleen, eliminates numbness, and clears heat and pus. The "Compendium of Materia Medica" states that it "treats thirst and thirst by promoting the production of body fluids, clearing away dampness and heat. Modern research confirms that coix seed acidic polysaccharides have anti-complementary activity, and that coix seed oil and coixol have a mild hypoglycemic effect in rabbits."

[0047] Plantago seed: Sweet and cold, it enters the kidney, liver, and lung meridians. It can follow the liver's nature to clear dampness and heat in the triple burner. The "Compendium of Materia Medica" states that it "clears pathogenic fire downward, reaching the heart and dispelling dampness and heat." Modern research indicates that the oxalate in plantago seed is a potent insulin sensitizer, increasing insulin receptor expression and insulin sensitivity. Furthermore, plantago seed polysaccharides can lower blood sugar by regulating intestinal microbial abundance and short-chain fatty acid levels.

[0048] Achyranthes bidentata: Bitter, sour, and neutral, it enters the Liver and Kidney meridians. Zhang Xichun stated that it "was originally a tonic, but it is also good at guiding Qi and blood downward. Therefore, when using a medicine to induce downward movement, it is often used as a guide." Therefore, while Astragalus membranaceus is used as the main ingredient to strengthen the spleen and raise the clearness to treat spleen deficiency, Achyranthes bidentata is used as a guiding agent to guide other heat-clearing and dampness-eliminating herbs downward, expelling dampness and heat through the urinary orifices. Achyranthes bidentata contains a variety of organic acids and polysaccharides, among which Achyranthes bidentata polysaccharides and their derivatives have hypoglycemic effects and have a certain preventive and therapeutic effect on diabetic nephropathy.

[0049] Based on the above-mentioned drug composition, the present application further provides the following preparation and administration methods:

[0050] First, weigh out each Chinese medicine according to the ratio of the raw materials, then add water until it covers the medicine surface by 3-5 cm, soak, boil over high heat, then simmer over low heat for 40-50 minutes, filter out the juice for later use, add water to the residue again, until it covers the residue surface by 1-2 cm, boil over high heat, then simmer over low heat for 20-30 minutes, filter out the juice and combine it with the previous juice to obtain the Chinese medicine decoction.

[0051] Dosage: Take 1 dose daily, divided into morning and evening, 1-2 hours after meals.

[0052] The drug obtained using the formulation and preparation method of this application has been clinically applied with remarkable efficacy. The inventors have demonstrated through extensive testing that the pharmaceutical composition of this application is effective in improving the symptoms and signs of type 2 diabetes and improving the quality of life of patients. Therefore, the technical solution of this application has significant advantages both in theory and in clinical effectiveness.

[0053] In summary, this application combines traditional Chinese medicine theory with the theory of disease-symptom combination to obtain a Chinese medicine composition specifically for the treatment of type 2 diabetes. It focuses on invigorating qi and detoxifying, clearing away heat and removing dampness, and combines spleen-tonifying and qi-invigorating drugs with heat-clearing and dampness-removing drugs. It nourishes without being greasy, removes dampness without damaging the body, and removes both dampness and heat, achieving the effect of invigorating the spleen, clearing heat and removing dampness. It has a significant effect on improving the symptoms and signs of type 2 diabetes and improving the quality of life of patients.

[0054] The present application is further described in detail below with reference to specific embodiments. These embodiments should not be construed as limiting the scope of protection claimed in this application.

[0055] Example 1

[0056] A Chinese medicine composition for treating type 2 diabetes, prepared from the following medicines:

[0057] Roasted Astragalus 30g, Coptis chinensis 5g, Phellodendron amurense 10g, Atractylodes lancea 9g, Achyranthes bidentata 30g, stir-fried Coix seed 20g, Plantago seed 30g.

[0058] The preparation method is as follows:

[0059] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add 1200mL of cold water, and soak for 1.5 hours;

[0060] (2) Boil the mixed raw materials over high heat, simmer for 45 minutes, and filter with gauze to obtain the filtrate and residue;

[0061] (3) The medicinal residue obtained in step (2) was mixed with 550 mL of hot water (purified water at 80°C) and decocted. The mixture was boiled over high heat, simmered over low heat for 25 minutes, and filtered again with gauze to obtain the filtrate and medicinal residue.

[0062] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating type 2 diabetes.

[0063] Example 2

[0064] A Chinese medicine composition for treating type 2 diabetes, prepared from the following medicines:

[0065] Roasted Astragalus 22g, Coptis chinensis 4g, Phellodendron amurense 8g, Atractylodes lancea 7g, Achyranthes bidentata 22g, stir-fried Coix seed 15g, Plantago seed 22g.

[0066] The preparation method is as follows:

[0067] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add 900mL of cold water, and soak for 1.5 hours;

[0068] (2) Boil the mixed raw materials over high heat, simmer for 40 minutes, and filter with gauze to obtain the filtrate and residue;

[0069] (3) The medicinal residue obtained in step (2) was mixed with 400 mL of hot water (purified water at 80°C) and decocted. The mixture was boiled over high heat, simmered over low heat for 20 minutes, and filtered again with gauze to obtain the filtrate and medicinal residue.

[0070] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating type 2 diabetes.

[0071] Example 3

[0072] A Chinese medicine composition for treating type 2 diabetes, prepared from the following medicines:

[0073] Roasted Astragalus 38g, Coptis chinensis 6g, Phellodendron amurense 13g, Atractylodes lancea 12g, Achyranthes bidentata 38g, stir-fried Coix seed 25g, Plantago seed 38g.

[0074] The preparation method is as follows:

[0075] (1) First, weigh out each Chinese medicine according to the ratio of raw materials, mix evenly, add 1500mL of cold water, and soak for 1.5 hours;

[0076] (2) Boil the mixed raw materials over high heat, simmer for 50 minutes, and filter with gauze to obtain the filtrate and residue;

[0077] (3) The medicinal residue obtained in step (2) was mixed with 600 mL of hot water (purified water at 80°C) and decocted. The mixture was boiled over high heat, simmered over low heat for 30 minutes, and filtered again with gauze to obtain the filtrate and medicinal residue.

[0078] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating type 2 diabetes.

[0079] Experimental example

[0080] 1. Clinical data

[0081] 1.1 Source of research subjects and sample size

[0082] Patients who have been diagnosed with type 2 diabetes, meet the TCM syndrome diagnosis, and require drug intervention were selected. The case data were collected from outpatients and inpatients of the Endocrinology Department of Tsinghua University Yuquan Hospital from September 2023 to December 2023.

[0083] 1.2 Diagnostic criteria

[0084] 1.2.1 Western medicine diagnostic criteria

[0085] The diagnostic criteria of the 2020 Guidelines for the Prevention and Treatment of Type 2 Diabetes in China issued by the Diabetes Branch of the Chinese Medical Association are adopted:

[0086] Patients with typical symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss), and random venous plasma glucose ≥11.1mmol / L, or fasting venous plasma glucose ≥7.0mmol / L, or venous plasma glucose ≥11.1mmol / L 2 hours after an oral glucose tolerance test, or HbA1c ≥6.5%. Patients without typical symptoms of diabetes need to be rechecked on another day.

[0087] 1.2.2 TCM syndrome diagnostic criteria

[0088] Based on the "Standards and Research on TCM Syndrome Differentiation and Efficacy Evaluation of Diabetes", "Guiding Principles for Clinical Research of New Chinese Medicine Drugs: Trial Implementation", and "Tsinghua University Yuquan Hospital Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Program for Type 2 Diabetes (2023 Edition)", the syndrome differentiation and classification standards for "Spleen and Stomach Damp-Heat Syndrome" in type 2 diabetes were formulated:

[0089] Main symptoms: abdominal distension, fatigue, poor appetite, thirst, nausea and vomiting;

[0090] Secondary symptoms: chest discomfort, low fever, dark yellow urine, and uncomfortable bowel movements;

[0091] Tongue and pulse: red tongue, yellow and greasy tongue coating, slippery and rapid pulse / soft and rapid pulse.

[0092] The diagnosis can be made if the above 3 main symptoms or 2 main symptoms + 1 secondary symptom / tongue and pulse are consistent.

[0093] T2DM patients who do not meet the above-mentioned TCM syndrome differentiation criteria are diagnosed as T2DM non-spleen and stomach damp-heat syndrome.

[0094] 1.3 Case selection criteria

[0095] 1.3.1 Inclusion criteria

[0096] ① Clear diagnosis of type 2 diabetes;

[0097] ② According to TCM diagnosis, it is spleen and stomach damp-heat syndrome;

[0098] ③Age 18-80 years old (inclusive), gender not limited;

[0099] ④Can provide detailed contact information, be willing to cooperate with follow-up and sign the informed consent form.

[0100] 1.3.2 Exclusion criteria

[0101] ① Patients with other types of diabetes;

[0102] ② Patients who have participated in other clinical drug trials in the past 3 months;

[0103] ③ Patients with concurrent acute infectious diseases, active and protracted chronic hepatitis B, decompensated cirrhosis, active tuberculosis, heart failure, cardiovascular accidents, trauma, recent surgery, etc.;

[0104] ④ Those who are known to be allergic to or severely allergic to this type of drug;

[0105] ⑤ Patients with severe primary diseases of the heart, brain, lung, liver, nervous system, hematopoietic system, etc.;

[0106] ⑥ Those with a history of diabetic ketoacidosis, diabetic hyperosmolar coma or other acute complications of diabetes within 6 months;

[0107] ⑦ Patients with intellectual disabilities or mental illnesses;

[0108] ⑧ Women who are pregnant or breastfeeding, or have pregnancy intentions, or have a positive pregnancy test (urine HCG or blood HCG);

[0109] ⑨ Those who are deemed unsuitable to participate in this clinical trial by the researchers.

[0110] 1.3.3 Shedding standards

[0111] All subjects who have completed the informed consent form and are screened as qualified to enter the trial, regardless of when or why they withdraw and do not complete the observation period specified in the protocol, are considered dropouts.

[0112] ① The occurrence of serious adverse reactions makes it impossible to continue the trial;

[0113] ② The patient's condition has changed significantly and is not suitable for continuing the trial;

[0114] ③The patient or his / her family members request to withdraw from the trial;

[0115] ④ The subjects' compliance is poor, which affects the judgment of efficacy and safety;

[0116] ⑤ Lost to follow-up.

[0117] After a subject drops out of the study, the researcher should contact the subject as much as possible, inquire about the reason, record the last time the medication was taken, complete all possible assessment items, and use the last test result as the final result for a full data set analysis of efficacy and adverse reactions. If a subject drops out due to allergic reactions, ineffective treatment, or other reasons, the researcher should implement appropriate treatment measures based on the subject's condition.

[0118] 1.3.4 Conditions for terminating the test

[0119] A trial suspension refers to the cessation of the entire clinical trial before it is completed as planned. The purpose of a trial suspension is to protect the rights and interests of the subjects, ensure trial quality, and avoid unnecessary financial losses.

[0120] ① Serious safety issues occur during the trial;

[0121] ② The drug is found to cause significant adverse reactions during the trial;

[0122] ③ Major errors in the protocol or significant deviations in protocol implementation are discovered during the trial, making it difficult to evaluate the drug effect;

[0123] ④ The applicant requests suspension (e.g. due to funding or management reasons);

[0124] ⑤ The administrative department cancels the test, etc.

[0125] 1.3.5 Criteria for exclusion of cases

[0126] ① Did not meet the inclusion criteria and was mistakenly included;

[0127] ② Although they meet the inclusion criteria, they have not taken any medication or have no follow-up records after inclusion;

[0128] ③ Changing medications on one's own or adding concomitant medications outside the prescribed range, especially drugs that have a significant impact on the study drugs, will affect the judgment of effectiveness and safety.

[0129] 1.3.6 Sample Size Estimation

[0130] Based on previous clinical observations, the mean TCM syndrome score after one month of conventional internal medicine hypoglycemic treatment was 18.47, and after one month of traditional Chinese medicine intervention, the mean TCM syndrome score was 16.02. The standard deviation of the TCM syndrome scores between the two groups was 3.2. The two-group ratio was 1:1, the α value was 0.05, and the β value was 0.1. Considering a 10% dropout rate, the total sample size was 80 patients, including 40 in the experimental group and 40 in the control group.

[0131] 2. Research Methods

[0132] 2.1 Randomization and allocation concealment

[0133] The study subjects were divided into a control group and an experimental group using a block randomization method. SPSS software generated a block randomization sequence with a block length of 4. Each study subject group was generated using the generated randomization sequence and placed in sequentially arranged, sealed, and light-proof envelopes. Eligible subjects agreed to enter the trial and opened the envelope corresponding to their assigned randomization number. They were then assigned to the corresponding group and received the intervention.

[0134] 2.2 Intervention methods

[0135] ① Control group: Received routine diabetes-lowering treatment. All participants received diabetes health education and developed a diabetes diet plan tailored to their specific circumstances. Patients taking Western medication maintained their original glucose-lowering regimen. Patients not taking medication were temporarily exempt from Western medication if their fasting blood glucose (FPG) was <8.0 mmol / L. If their FPG was >8.0 mmol / L, different glucose-lowering medications were selected based on their blood glucose levels, body type, tolerance, and personal preferences.

[0136] ② Experimental group: Huangqi Simiao Decoction was taken orally on the basis of routine hypoglycemic treatment in internal medicine.

[0137] Huangqi Simiao Decoction consists of: roasted Astragalus root 30g, Coptis root 5g, Phellodendron amurense 10g, Atractylodes macrocephala 9g, Achyranthes bidentata 30g, stir-fried Coix seed 20g, and Plantago seed 30g. Boil 200mL of each herb combination and take half warm in the morning and evening, once daily. The decoction was prepared by the Traditional Chinese Medicine Pharmacy of Tsinghua University Yuquan Hospital.

[0138] ③ Combined medication: During the intervention period, the subjects can continue to use previous lipid-lowering, antihypertensive, antiplatelet aggregation and other therapeutic drugs according to their actual condition, and fill in the case report form.

[0139] ④ In previous clinical treatment, Huangqi Simiao Decoction typically showed results within 2 weeks, and no longer than 4 weeks. If the patient's symptoms did not improve significantly after 4 weeks, the prescription was considered incompatible with the syndrome, and a change of prescription was necessary. Therefore, the intervention period was set at 4 weeks.

[0140] 2.3 Efficacy evaluation indicators

[0141] 2.3.1 Traditional Chinese Medicine Indicators: Traditional Chinese Medicine Syndrome Scoring Scale

[0142] Evaluation criteria: Syndrome score reduction rate = [(score before treatment - score after treatment) / score before treatment] × 100% (refer to nimodipine method).

[0143] ① Clinically cured: TCM clinical symptoms and signs disappear or basically disappear, and the syndrome score reduction rate is ≥90%;

[0144] ② Markedly effective: clinical symptoms and signs of TCM are significantly improved, with the syndrome score reduction rate ≥ 70%;

[0145] ③ Effective: TCM clinical symptoms and signs are improved, and the syndrome score reduction rate is ≥30%;

[0146] ④ Ineffective: There is no significant improvement in TCM clinical symptoms and signs, or they may even worsen, and the symptom score reduction rate is <30%.

[0147] 2.3.2 Western medicine indicators

[0148] ①Fasting blood glucose (FPG) and 2h postprandial blood glucose (2hPG); ②Glycated albumin (GA); ③Fasting insulin (FINS), homeostasis model assessment of insulin resistance index (HOMA-IR), homeostasis model assessment of insulin beta index (HOMA-β), fasting C-peptide; ④Four blood lipids (TG, CHO, HDL-C, LDL-C); ⑤Body mass index (BMI); ⑥Waist and abdominal circumference.

[0149] Note: HOMA-IR=FPG×FINS / 22.5, HOMA-β=20×FINS / (FPG-3.5), FPG is expressed in mmol / L, and FINS is expressed in mIU / L.

[0150] 2.3.3 Safety indicators

[0151] ① Basic vital signs; ② Routine blood and urine tests; ③ Liver and kidney function (ALT, AST, SCr, BUN); ④ Electrocardiogram; ⑤ Incidence of adverse events;

[0152] Main efficacy indicators: TCM syndrome scores of patients before and after treatment;

[0153] Secondary efficacy indicators: FPG, 2hPG, GA, FINS, HOMA-IR, HOMA-β, four blood lipids, BMI, waist and abdominal circumference of patients before and after treatment.

[0154] 2.3.4 Statistical analysis methods

[0155] Statistical analysis was performed using SPSS 20.0 software. The chi-square test was used to compare gender between the two groups. Enumeration data were expressed as frequencies and percentages; measurement data were expressed as mean ± standard deviation (x ± S). Paired sample t-tests were used for intra-group comparisons, and independent sample t-tests were used for inter-group comparisons. Nonparametric tests were used for nonnormal data. A P value greater than 0.05 was considered statistically insignificant, a P value less than 0.05 was considered statistically significant, and a P value less than 0.01 was considered significantly different.

[0156] 2.4 Research Results

[0157] Among the 80 patients with T2DM and spleen-stomach damp-heat syndrome enrolled in this study, four patients were discontinued from observation according to exclusion, discontinuation, and dropout criteria. One patient in the experimental group voluntarily withdrew for personal reasons, resulting in one dropout. Two patients in the control group also voluntarily withdrew for personal reasons, and one patient was excluded for self-administering Chinese patent medicine, resulting in three dropouts. The final number of effective cases in the experimental group was 39, and in the control group was 37.

[0158] 2.4.1 Comparability Analysis of the Two Groups of Subjects

[0159] 2.4.1.1 General Condition and Comparison of Baseline Indicators Before Intervention

[0160] Statistical analysis was performed on the general conditions and pre-intervention baselines of the two groups to ensure comparability. The baseline comparison of the observed indicators before treatment in the two groups is shown in Table 1. The control group consisted of 23 male patients and 14 female patients, with an age of 80 years and a youngest of 36 years. The average disease course was 154.19 ± 119.67 months. The experimental group consisted of 26 male patients and 13 female patients, with an age of 76 years and a youngest of 34 years. The average disease course was 128.87 ± 104.75 months. Statistical analysis with SPSS 20.0 software showed no statistically significant differences in gender composition, age, or average disease course between the two groups (P > 0.05), indicating comparability. In addition, there was no statistical difference in the baseline information of efficacy evaluation indicators and safety indicators such as TCM syndrome score, FPG, 2hPG, GA, FINS, fasting C-peptide, TG, CHO, HDLC, LDL-C, BMI, waist and abdominal circumference, ALT, AST, SCr, and BUN between the two groups of patients (P>0.05), and the two groups were comparable.

[0161] Table 1 Comparison of baseline indicators between the two groups before treatment

[0162]

[0163] 2.4.2 Comparison of Observation Indicators between the Two Groups after Treatment

[0164] 2.4.2.1 Comparison of TCM syndrome scores

[0165] Intra-group comparisons were performed in the control group and the experimental group before and after treatment. The comparison of TCM syndrome scores between the two groups before and after treatment is shown in Table 2, and the comparison of TCM syndrome score reduction rates between the two groups is shown in Table 3.

[0166] Statistical results showed that the differences in individual TCM symptom scores and total TCM symptom scores before and after treatment in the experimental group were statistically significant (P < 0.01), indicating that the experimental group's treatment regimen effectively improved the TCM symptoms of spleen-stomach damp-heat syndrome in T2DM. There was no statistically significant difference in the symptom score of constipation in the control group before and after treatment (P > 0.05), but the differences in the scores of the remaining individual TCM symptoms and total TCM symptom scores were statistically significant (P < 0.05), indicating that the control group's treatment regimen effectively improved all TCM symptoms of spleen-stomach damp-heat syndrome in T2DM, except for constipation.

[0167] Comparisons between the experimental and control groups after treatment revealed no statistically significant difference in the TCM symptom of abdominal distension between the two groups (P>0.05). However, statistically significant differences were observed in other individual TCM symptoms and the total TCM symptom score (P<0.05). This suggests that the experimental group's treatment regimen was more effective than the control group's in improving TCM symptoms other than abdominal distension in patients with spleen-stomach damp-heat syndrome of T2DM. Regarding the reduction rate of symptom scores, the control group had a total effective rate of 48.65%; the experimental group had a total effective rate of 79.49%. The total effective rate of Huangqi Simiao Decoction in the experimental group was significantly higher than that of Western medicine alone in the control group (P<0.01), indicating that the experimental group's treatment regimen was more effective overall than the control group's.

[0168] Table 2 Comparison of TCM syndrome scores between the two groups before and after treatment

[0169]

[0170] Table 3 Comparison of TCM syndrome score reduction rate between the two groups

[0171]

[0172] 2.4.2.2 Blood glucose metabolism indicators

[0173] Before and after treatment, the control group and the experimental group were compared within the same group. Statistical analysis showed that the comparison of the three blood glucose-related indicators of FPG, 2hPG and GA between the experimental group and the control group was P < 0.01, indicating that there were significant differences. This suggests that both the experimental group treatment regimen and the control group treatment regimen can effectively improve the blood glucose-related indicators of T2DM spleen and stomach damp-heat syndrome.

[0174] After treatment, a comparison between the experimental and control groups revealed statistically significant differences in all blood glucose-related indicators between the two groups (P < 0.05). This suggests that the Huangqi Simiao Decoction treatment regimen in the experimental group was more effective than the simple glucose-lowering treatment regimen in improving FPG, 2hPG, and GA in patients with T2DM with spleen-stomach damp-heat syndrome. Specific results are shown in Table 4.

[0175] Table 4 Comparison of blood glucose metabolism indicators between the two groups before and after treatment

[0176]

[0177] 2.4.2.3 Lipid Metabolism Indicators

[0178] Intragroup comparisons were performed before and after treatment in the control and experimental groups. After treatment, CHO levels in the control group decreased significantly (P < 0.05), while TG, HDL-C, and LDL-C levels did not change significantly (P > 0.05), suggesting that the treatment regimen in the control group effectively reduced CHO levels. After treatment, CHO, TG, and LDL-C levels in the experimental group decreased significantly (P < 0.01), while HDL-C levels did not change significantly (P > 0.05), suggesting that the treatment regimen in the experimental group effectively improved CHO, TG, and LDL-C levels.

[0179] After treatment, a comparison between the experimental and control groups revealed statistically significant differences in CHO and LDL-C between the two groups (P < 0.05), but no statistically significant differences in TG and HDL-C (P > 0.05). This suggests that the Huangqi Simiao Decoction treatment regimen in the experimental group was more effective than the Western medicine-only hypoglycemic treatment regimen in the control group in improving CHO and LDL-C, while there was no significant difference in TG and HDL-C between the two groups. Specific results are shown in Table 5.

[0180] Table 5 Comparison of blood lipid metabolism indicators between the two groups of subjects before and after treatment

[0181]

[0182] 2.4.2.4 Insulin-related indicators

[0183] First, insulin-related indices were compared between the two groups before and after intervention. In the control group, there were no statistically significant changes in FINS, HOMA-IR, and fasting C-peptide levels after treatment compared with those before treatment (P>0.05), while HOMA-β was significantly increased (P<0.05). In the experimental group, FINS and HOMA-IR were significantly decreased after treatment (P>0.05), while HOMA-β was significantly increased (P<0.05). There was no statistically significant change in fasting C-peptide levels (P>0.05). There were statistically significant differences in FINS and HOMA-IR between the two groups after treatment (P<0.05), but no statistically significant differences in HOMA-β and fasting C-peptide between the two groups (P>0.05). Detailed results are shown in Table 6.

[0184] In addition, we compared FINS, HOMA-IR, and HOMA-β before and after intervention in 48 subjects not using insulin (20 in the control group and 28 in the experimental group). After treatment, HOMA-β in the control group increased significantly (P < 0.05), while the changes in FINS and HOMA-IR were not statistically significant (P > 0.05). In the experimental group, FINS, HOMA-IR, and HOMA-β all improved significantly after treatment (P < 0.05). Post-treatment comparisons between the two groups showed statistically significant differences in FINS and HOMA-IR (P < 0.05), but no statistically significant difference in HOMA-β (P > 0.05). Detailed results are shown in Table 7.

[0185] Table 6 Comparison of insulin-related indicators between the two groups of subjects before and after treatment

[0186]

[0187] Table 7 Comparison of FINS, HOMA-IR and HOMA-β before and after treatment in the two groups of subjects who did not use insulin

[0188]

[0189] 2.4.2.5 BMI and waist circumference

[0190] Before and after treatment, intragroup comparisons of the control and experimental groups revealed a statistically significant decrease in BMI (P < 0.05) in the control group, while no significant improvement in waist and abdominal circumference (P > 0.05) was observed, indicating that the treatment regimen in the control group effectively reduced patients' BMI. In the experimental group, both BMI and waist and abdominal circumference decreased after treatment, with statistically significant differences (P < 0.05), indicating that the treatment regimen in the experimental group effectively reduced patients' BMI and waist and abdominal circumference. Intergroup comparisons between the experimental and control groups after treatment revealed no statistically significant differences in BMI and waist and abdominal circumference between the two groups (P > 0.05). Detailed results are shown in Table 8.

[0191] Table 8 Comparison of BMI and waist circumference between the two groups before and after treatment

[0192]

[0193] 2.4.2.6 Security Analysis

[0194] After treatment, one subject in the control group (2.70%) experienced gastrointestinal discomfort, and two subjects in the experimental group (5.13%) experienced gastrointestinal discomfort. None of the subjects recovered on their own without taking medication, and no serious adverse events occurred. There was no statistically significant difference in the incidence of adverse reactions between the two groups (P>0.05). Basic vital signs, blood routine tests, urine routine tests, and electrocardiograms in both groups after treatment did not change significantly compared to pre-treatment, indicating that the medication used in this trial was safe.

[0195] 2. Case data

[0196] Case 1:

[0197] Ms. Li, 44 years old, first visited the hospital on January 6, 2025. Chief complaint: Hyperglycemia for six years. Current medical history: Six years prior, a physical examination revealed elevated blood sugar levels, with a fasting blood sugar of 7.8 mmol / L. She took oral metformin hydrochloride tablets 0.5 mg tidly and dapagliflozin 10 mg daily. Her blood sugar control was poor, with self-measured fasting blood sugar levels of 9-11 mmol / L and postprandial blood sugar levels of 12-14 mmol / L. She sought further diagnosis and treatment. Current symptoms: fatigue, dry mouth, bitter taste, aversion to heat, good appetite, sticky, unformed stools, normal urination, dark red tongue with a greasy yellow coating, and a deep, thready pulse. Examination revealed FBG of 10.2 mmol / L and HbA1c of 8.6%. Western medicine diagnosis: type 2 diabetes; Traditional Chinese Medicine diagnosis: diabetes mellitus. Syndrome differentiation: Qi deficiency and damp-heat syndrome. Treatment: Invigorate Qi, clear heat, and dispel dampness. Prescription: Roasted Astragalus 30g, Atractylodes 9g, Coptis 5g, Phellodendron 10g, Achyranthes 30g, Stir-fried Coix Seed 20g, Plantago 30g, prepared according to the method of Example 1, 1 dose (200ml) per day, taken warm in the morning and evening, 7 packs;

[0198] Follow-up visit on January 13, 2025: The patient reported improvement in fatigue and aversion to heat, less dryness and bitterness in the mouth, a good appetite, sticky and unformed stools, a red tongue with a greasy yellow coating, and a deep, thready pulse. Self-measured fasting blood sugar was 8-10 mmol / L and postprandial blood sugar was 10-12 mmol / L. He continued to take the above medicine for 10 doses.

[0199] Follow-up visit on January 23, 2025: The patient's fatigue, aversion to heat, and dry mouth and bitter taste all improved significantly. Appetite was good, and sticky stools were less sticky than before. The tongue was dark red with a yellow coating, and the pulse was deep and thready. Self-measured fasting blood sugar was 7-8 mmol / L, and postprandial blood sugar was 8-10 mmol / L. To consolidate the therapeutic effect, the above formula was continued for 7 doses.

[0200] Case 2:

[0201] Du, female, 32 years old, first visit on November 27, 2023. Chief complaint: elevated blood sugar for 1 month. Current medical history: The patient was hospitalized 1 month ago and was found to have elevated blood sugar, FBG 9.2mmol / L, HbA1c8.1%. In order to further control blood sugar, she came to our outpatient clinic for treatment. Current symptoms: aversion to heat, dry mouth and bitter taste, fatigue and weakness, scattered boils on the limbs, poor appetite, regular bowel movements, good sleep, red tongue with thick and greasy yellow fur, and deep pulse. Western medicine diagnosis: type 2 diabetes; Traditional Chinese Medicine diagnosis: diabetes mellitus, syndrome differentiation: syndrome of qi deficiency and damp-heat. Treatment: invigorating qi, clearing heat and removing dampness. Prescription: roasted Astragalus 30g, Atractylodes 9g, Coptis 5g, Phellodendron 10g, Achyranthes 30g, stir-fried Coix Seed 20g, Plantago 30g, Chinese medicine decoction obtained according to the preparation method of Example 1, 1 dose of 200ml per day, warm in the morning and evening, 7 pairs;

[0202] Follow-up visit on December 4, 2023: The patient reported improved fatigue, but still had aversion to heat, dry mouth and bitter taste. His appetite was good, the carbuncle had decreased, his bowel movements were regular, and he was sleeping well. His tongue was red with a greasy yellow coating, and his pulse was deep. His fasting blood sugar was 7-9 mmol / L, and his postprandial blood sugar was 9-13 mmol / L. He continued to take the above medicine for 14 doses.

[0203] Follow-up on December 18, 2023: The patient's aversion to heat and dry mouth and bitter taste have significantly improved, his appetite has improved, the carbuncle has disappeared, his bowel movements have become regular, his sleep has improved, his tongue is red with a yellow coating, and his pulse is deep. Self-measured fasting blood sugar is 7-8mmol / L, and postprandial blood sugar is 9-11mmol / L. He continued to take 7 doses of the medicine to consolidate the therapeutic effect. Follow-up by phone showed that his quality of life has significantly improved.

[0204] The above description is merely a preferred embodiment of the present application; however, the scope of protection of the present application is not limited thereto. Any person skilled in the art who, within the technical scope disclosed in the present application, makes equivalent substitutions or modifications based on the technical solutions and improved concepts of the present application shall be covered by the scope of protection of the present application.

Claims

1. A Chinese medicine composition for treating type 2 diabetes, characterized in that: The Chinese medicine composition comprises the following components: Roasted Astragalus, Coptis chinensis, Phellodendron amurense, Atractylodes lancea, Achyranthes bidentata, stir-fried Coix seed, Plantago seed.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises the following components in parts by weight: 20-40 parts of roasted Astragalus, 4-10 parts of Coptis chinensis, 4-20 parts of Phellodendron amurense, 5-20 parts of Atractylodes lancea, 20-40 parts of Polygonum multiflorum, 10-30 parts of stir-fried Coix seeds, and 20-40 parts of Plantago seeds.

3. The Chinese medicine composition according to claim 2, characterized in that The Chinese medicine composition comprises the following components in parts by weight: 26-34 parts of roasted Astragalus, 4-9 parts of Coptis chinensis, 4-14 parts of Phellodendron amurense, 6-14 parts of Atractylodes lancea, 25-35 parts of Polygonum multiflorum, 15-25 parts of stir-fried Coix seeds, and 25-35 parts of Plantago seeds.

4. The Chinese medicine composition according to claim 3, characterized in that The Chinese medicine composition comprises the following components in parts by weight: 30 parts of roasted Astragalus, 5 parts of Coptis chinensis, 10 parts of Phellodendron amurense, 9 parts of Atractylodes macrocephala, 30 parts of Rhizoma Cyathulae, 20 parts of stir-fried Coix seeds, and 30 parts of Plantago seeds.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The steps include: Weigh the prescribed amount of each Chinese medicine, decoct them, and take the medicinal juice.

6. The preparation method according to claim 5, characterized in that The steps include: Weigh the prescribed amount of each Chinese medicine, mix them, add water to cover the medicine surface by 3 to 5 cm, soak for 1.5 to 2 hours, boil over high heat, then simmer over low heat for 40 to 50 minutes, separate the solid and liquid, and obtain a first medicinal juice and a first medicinal residue; Add water to the first medicinal residue again, covering the surface of the medicinal residue by 1 to 2 cm, boil over high heat, and then simmer over low heat for 20 to 30 minutes to separate the solid and liquid to obtain the second medicinal juice; The first and second concoctions are combined.

7. A medicine for treating type 2 diabetes, characterized in that The raw materials of the medicine include the traditional Chinese medicine composition according to any one of claims 1 to 4.

8. The drug according to claim 7, characterized in that The drug also includes pharmaceutically acceptable excipients.

9. The drug according to claim 7 or 8, characterized in that The dosage form of the drug includes oral preparations or injection preparations; The oral preparations include tablets, capsules, granules, pills, syrups, oral solutions, oral suspensions or oral emulsions; The injection preparation includes injection solution or powder injection.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 or the medicine according to any one of claims 7 to 9 in the preparation of a product for treating type 2 diabetes.

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