A traditional Chinese medicine composition for inhibiting hunger in diabetic patients

Abstract

The application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for inhibiting hunger of a diabetes patient. The application breaks a vicious circle of disease progression by targeting and inhibiting pathological hunger of a type II diabetes patient, and improves eating control ability. The traditional Chinese medicine composition is composed of Huanglian tablets, Huangqin tablets, vinegar Ju-jing, Fa-banxia, Ganjiang, Xiebai, Danshen, Sanqi and Chaojuemingzi. The application is a pure traditional Chinese medicine oral preparation, has a low incidence of gastrointestinal adverse reactions, is suitable for long-term intervention management of diabetes metabolic disorder and hunger hyperfunction, simultaneously reduces blood sugar, adjusts blood fat and improves body composition while inhibiting hunger, has a simplified prescription, commonly used and easily obtained medicinal materials, can be directly decocted and taken in clinic, and has wide applicability.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for suppressing hunger in diabetic patients. Background Technology

[0002] Diabetes mellitus (DM) is a chronic metabolic disease characterized by disordered carbohydrate metabolism. Patients cannot effectively utilize glucose for energy, while gluconeogenesis and glycogenolysis are abnormally enhanced, leading to excessive production of endogenous glucose and ultimately manifesting as persistent hyperglycemia. As a globally prevalent chronic disease, the long-term harm of diabetes is mainly reflected in the continuous impact of various complications on patients' quality of life and health.

[0003] Based on etiology and clinical characteristics, diabetes is mainly divided into three categories: type 1 diabetes, type 2 diabetes, and gestational diabetes. Among them, type 2 diabetes mellitus (T2DM) is the most common and has a complex pathological mechanism. Its core pathological features include insulin resistance, glucose homeostasis imbalance, and chronic low-grade inflammation. It is often accompanied by a variety of serious complications and has become a major public health problem threatening human health. Type 2 diabetes often develops from prediabetes, which is an intermediate state between normal blood glucose and diagnosed diabetes. Specifically, it includes impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and a mixed state of both. Under normal circumstances, 5% to 10% of people with prediabetes will progress to clinical diabetes each year. Long-term follow-up data shows that approximately 70% of individuals with prediabetes will eventually develop diabetes.

[0004] In recent years, natural products have received widespread attention in type 2 diabetes intervention research due to their advantages such as multiple targets and low toxicity. Current clinical interventions for diabetes-related pathological hunger are mainly divided into two categories: Western medicine drug intervention and traditional Chinese medicine compound intervention. Western medicine focuses on GLP-1 receptor agonists (GLP-1RAs, which are drugs that mimic the natural GLP-1 hormone in the gut) to suppress hunger by regulating the appetite center and improving food control; this is currently the mainstream clinical approach. Traditional Chinese medicine primarily uses methods such as strengthening the spleen and replenishing qi, clearing heat and promoting body fluids, and nourishing yin and lowering blood sugar as basic treatment principles. However, existing compound preparations mainly target conventional symptoms of diabetes such as dry mouth and polydipsia, lacking a formula closely aligned with the core pathogenesis of diabetes-related pathological hunger, and also lacking research using internationally recognized indicators such as the VAS appetite score and the CoEQ (CoE) to verify the hunger-suppressing effect.

[0005] Existing intervention programs have significant limitations: Western medicine GLP-1RA drugs have a high incidence of gastrointestinal adverse reactions and poor long-term medication adherence, making it difficult to fundamentally break the vicious cycle of "excessive hunger-polyphagia-dyslipidemia"; most traditional Chinese medicine formulas do not address the core pathogenesis of excessive hunger caused by "stomach heat and spleen deficiency, phlegm turbidity and blood stasis" in diabetes, and lack a scientific and unified efficacy evaluation system; most programs only focus on the regulation of a single blood glucose indicator, ignoring that hunger is a key trigger for the progression of diabetes, making it difficult to achieve long-term stable management of diabetes. Summary of the Invention

[0006] This invention breaks the vicious cycle of disease progression and improves food control by targeting and suppressing pathological hunger in patients with type 2 diabetes. Based on this, the invention was completed.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition comprising the following traditional Chinese medicines in parts by weight: 2-10 parts of Coptis chinensis slices, 5-12 parts of Scutellaria baicalensis slices, 2-15 parts of vinegar-processed Curcuma longa, 5-12 parts of processed Pinellia ternata, 2-10 parts of dried ginger, 2-15 parts of Allium macrostemon, 5-20 parts of Salvia miltiorrhiza, 1-6 parts of Panax notoginseng, and 5-20 parts of stir-fried Cassia tora seeds.

[0008] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 4-8 parts of Coptis chinensis tablets, 8-10 parts of Scutellaria baicalensis tablets, 10-15 parts of vinegar-processed Curcuma longa, 5-12 parts of processed Pinellia ternata, 4-8 parts of dried ginger, 10-15 parts of Allium macrostemon, 12-18 parts of Salvia miltiorrhiza, 2-5 parts of Panax notoginseng, and 12-18 parts of Cassia tora.

[0009] More preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicines in parts by weight: 6 parts Coptis chinensis tablets, 9 parts Scutellaria baicalensis tablets, 12 parts vinegar-processed Curcuma longa, 9 parts processed Pinellia ternata, 6 parts dried ginger, 12 parts Allium macrostemon, 15 parts Salvia miltiorrhiza, 3 parts Panax notoginseng, and 15 parts stir-fried Cassia tora.

[0010] In a second aspect, the present invention provides a traditional Chinese medicine preparation made from the traditional Chinese medicine composition described in the first aspect, wherein the traditional Chinese medicine preparation is selected from one or more of ointments, oral liquids, pills, decoctions, teas, granules, capsules, tablets, powders and / or powders.

[0011] Furthermore, the traditional Chinese medicine preparation is a decoction, and the preparation method of the decoction includes the following steps: S01: Prepare the Chinese herbal raw materials according to the required proportions; S02: Soak the Chinese herbal medicine raw materials prepared in S01; S03: Boil the raw materials and soaking liquid several times; S04: The combined concentrated S03 solution is the decoction described in this application.

[0012] Furthermore, in step S02, the ratio of material to liquid for soaking is 1:10, and the soaking time is 20-30 minutes.

[0013] Furthermore, in step S03, the decocting process involves first bringing the mixture to a boil over high heat and then simmering it over low heat for 60-120 minutes, and the decocting process is repeated three times.

[0014] Furthermore, the traditional Chinese medicine preparation may contain pharmaceutically acceptable excipients.

[0015] Furthermore, the pharmaceutically acceptable excipients are pharmaceutical excipients that enhance the efficacy of the active pharmaceutical ingredient, reduce its toxicity, and / or alleviate its side effects.

[0016] Thirdly, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect in a medicament for suppressing hunger in diabetic patients.

[0017] Furthermore, diabetes refers to a chronic metabolic disease caused by insulin resistance, blood glucose homeostasis imbalance, and chronic low-grade inflammation, with long-term elevated blood glucose as its core characteristic.

[0018] Furthermore, the hunger sensation refers to the subjective physiological craving mediated by the hypothalamus feeding center when the body's energy and nutrient intake is insufficient and blood sugar levels drop. It manifests as a strong desire to eat, which helps prompt individuals to eat and plays a role in regulating homeostasis.

[0019] Furthermore, the hunger sensation in diabetic patients refers to the pathological hunger sensation caused by disordered insulin secretion, which prevents glucose from entering cells normally for energy. Although the body's blood sugar is high, the cells are deficient in sugar, resulting in frequent fasting or premature hunger after meals. This is a pathological hunger sensation caused by disordered glucose metabolism.

[0020] Furthermore, the traditional Chinese medicine composition can be used in combination with other hypoglycemic drugs.

[0021] Furthermore, the other hypoglycemic drugs mentioned include, but are not limited to, metformin, dapagliflozin, and insulin.

[0022] The medicinal properties and effects of each Chinese medicinal herb in this invention are as follows: Coptis chinensis: Bitter, cold. It enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. It clears heat and dries dampness, drains fire and detoxifies. Used for damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever with delirium, excessive heart fire, restlessness and insomnia, palpitations, hematemesis due to blood heat, red eyes, toothache, thirst, carbuncles and boils; externally used for eczema, damp sores, and ear discharge. Wine-processed Coptis chinensis effectively clears heat from the upper burner. Used for red eyes and mouth sores. Ginger-processed Coptis chinensis clears and harmonizes the stomach and stops vomiting. Used for alternating chills and fever, damp-heat obstruction, fullness, and vomiting. Cornus-processed Coptis chinensis soothes the liver, harmonizes the stomach, and stops vomiting. Used for liver-stomach disharmony, vomiting and acid regurgitation.

[0023] Scutellaria baicalensis: Bitter, cold. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It clears heat and dries dampness, drains fire and detoxifies, stops bleeding, and calms the fetus. It is used for damp-heat syndrome, summer-heat syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, blood-heat vomiting and nosebleeds, carbuncles and boils, and threatened abortion.

[0024] Turmeric: pungent, bitter, and cold. It enters the liver, heart, and lung meridians. It invigorates blood and relieves pain, regulates qi and relieves depression, clears heat from the heart and cools the blood, promotes bile secretion and reduces jaundice. It is used for stabbing pain in the chest and hypochondrium, chest pain, amenorrhea, dysmenorrhea, breast distension and pain, delirium due to febrile diseases, epilepsy, hematemesis due to blood heat, and jaundice with dark urine.

[0025] Pinellia ternata (processed): pungent, warm. Enters the spleen, stomach, and lung meridians. Dries dampness and resolves phlegm. Used for cough and asthma with excessive phlegm, dizziness and palpitations due to phlegm retention, vertigo due to wind-phlegm, and headache due to phlegm syncope.

[0026] Dried ginger: pungent and hot in nature. It enters the spleen, stomach, kidney, heart, and lung meridians. It warms the middle jiao (spleen and stomach), dispels cold, restores yang, unblocks the meridians, warms the lungs, and resolves phlegm. It is used for cold pain in the epigastrium and abdomen, vomiting and diarrhea, cold limbs and weak pulse, and cough with phlegm due to cold.

[0027] Allium macrostemon: pungent, bitter, and warm. It enters the heart, lung, stomach, and large intestine meridians. It promotes yang, disperses stagnation, regulates qi, and relieves stagnation. It is used for chest pain, abdominal distension and pain, and tenesmus after diarrhea.

[0028] Salvia miltiorrhiza: Bitter, slightly cold. It enters the heart and liver meridians. It invigorates blood circulation and removes blood stasis, regulates menstruation and relieves pain, clears the heart and eliminates irritability, cools the blood and reduces swelling. It is used for chest pain, abdominal and hypochondriac pain, abdominal masses, painful arthralgia due to heat, insomnia due to irritability, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0029] Panax notoginseng: Sweet, slightly bitter, warm. It enters the liver and stomach meridians. It disperses blood stasis, stops bleeding, reduces swelling, and relieves pain. It is used for hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic bleeding, chest and abdominal pain, and swelling and pain from falls.

[0030] Cassia seed: Sweet, bitter, and salty; slightly cold in nature. It enters the liver and large intestine meridians. It clears heat and improves vision, moistens the intestines and promotes bowel movements. It is used for red, sore, and painful eyes, photophobia with excessive tearing, headache and dizziness, blurred vision, and constipation.

[0031] The formulation and treatment principles of this invention This invention addresses the core pathogenesis of type II diabetes mellitus, characterized by pathological hunger, excessive hunger, and disordered glucose and lipid metabolism, stemming from stomach heat, spleen deficiency, phlegm stagnation, and blood stasis. It uses Coptis chinensis as the principal herb to fundamentally suppress the excessive hunger caused by stomach heat. Scutellaria baicalensis tablets, vinegar-processed Curcuma longa, processed Pinellia ternata, dried ginger, and Allium macrostemon are used as assistant herbs to synergistically alleviate symptoms of excessive hunger and unbearable hunger, enhancing the heat-clearing and hunger-suppressing effects of the principal herb. This addresses the root cause of abnormal hunger due to spleen and stomach dysfunction, while mitigating the spleen-damaging effects of Coptis chinensis and Scutellaria baicalensis. The formula combines cooling and warming herbs, and uses pungent and bitter herbs to descend and disperse, which aligns with the complex pathogenesis of this disease. Danshen and Panax notoginseng powder are used as adjuvant herbs to improve the body's microcirculation, resolve pathological products such as phlegm and blood stasis, and assist the principal and assistant herbs in restoring metabolic function. Fried cassia seed is used as the guiding herb to direct the medicinal power of all the herbs in the formula to the gastrointestinal tract, targeting the lesion site and enhancing the efficacy of the medicine. It clears heat and unblocks the bowels to help the gastrointestinal tract expel pathogenic heat, moistens the intestines and promotes bowel movements to improve gastrointestinal stagnation, and simultaneously assists in lowering lipids and clearing turbidity, synergistically improving glucose and lipid metabolism disorders.

[0032] Beneficial effects The herbal composition of this invention uses Coptis chinensis as the principal ingredient to directly target the core pathogenesis of diabetes, which involves stomach heat and spleen deficiency. It precisely inhibits pathological hunger and promotes aversion to food, thus breaking the vicious cycle of disease progression.

[0033] The herbal composition of this invention combines cold and hot properties, pungent and bitter properties, and phlegm-resolving and blood-activating effects, with clear distinctions between the principal, assistant, adjuvant, and guide herbs, which meets the requirements of traditional Chinese medicine theory and patent examination compatibility.

[0034] The herbal composition of this invention suppresses hunger while simultaneously lowering blood sugar, regulating lipids, and improving body composition, thus achieving comprehensive intervention in metabolic disorders.

[0035] The herbal composition of this invention is a pure oral preparation of traditional Chinese medicine, with a low incidence of gastrointestinal adverse reactions, and is suitable for long-term use by patients.

[0036] The traditional Chinese medicine composition of this invention has a simplified formula, uses commonly used and readily available medicinal materials, and can be directly decocted and taken in clinical practice, making it widely applicable. Detailed Implementation

[0037] The specific embodiments of the present invention will be further described below. It should be noted that these descriptions are for the purpose of aiding understanding the present invention, but do not constitute a limitation thereof. Furthermore, the technical features involved in the embodiments described below can be combined with each other as long as they do not conflict with each other.

[0038] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods, and the experimental materials used in the following embodiments are all available through conventional commercial channels.

[0039] Example 1: Preparation of the traditional Chinese medicine preparation of the present invention The herbal composition consists of: 6g of Coptis chinensis tablets, 9g of Scutellaria baicalensis tablets, 12g of vinegar-processed Curcuma longa, 9g of processed Pinellia ternata, 6g of dried ginger, 12g of Allium macrostemon, 15g of Salvia miltiorrhiza, 3g of Panax notoginseng, and 15g of stir-fried Cassia tora seeds.

[0040] Preparation process: The first step is to weigh the Chinese herbs according to the required ingredients and proportions, remove impurities, wash them, drain the water, and set them aside. The second step is to mix the Chinese herbs processed in the first step and soak them in a 1:10 ratio of materials to liquid for 30 minutes. The third step is to boil the raw material mixture in the soaking liquid over high heat, then simmer over low heat for 30 minutes, repeating this process several times. The fourth step is to combine and concentrate the decoctions from several decoctions under reduced pressure until the amount of raw medicinal material is 1g / mL. The resulting decoction is the decoction of this invention, which should be stored at 4°C for later use.

[0041] The dosage form of the traditional Chinese medicine composition of the present invention can be prepared into different dosage forms such as granules, tablets, and oral liquids according to conventional techniques in the field (Chinese Pharmacopoeia), and is not limited to one type.

[0042] Example 2: Clinical evaluation of the traditional Chinese medicine composition of the present invention 1. Traditional Chinese Medicine Formula Coptis chinensis slices 6g, Scutellaria baicalensis slices 9g, Curcuma longa (vinegar-processed) 12g, Pinellia ternata (processed) 9g, Zingiber officinale (dried) 6g, Allium macrostemon 12g, Salvia miltiorrhiza 15g, Panax notoginseng 3g, and Cassia tora (fried) 15g.

[0043] 2. Research Methods Using a randomized, parallel-controlled, prospective clinical observation method, patients with type II diabetes who met the diagnostic criteria of traditional Chinese medicine or Western medicine were divided into an experimental group and a control group. The experimental group received the traditional Chinese medicine composition of this invention combined with basic hypoglycemic treatment, while the control group received basic hypoglycemic treatment alone. The intervention lasted for 12 consecutive weeks.

[0044] 3. Research Subjects Sixty patients from the outpatient and inpatient departments of the Department of Endocrinology at Shaanxi Academy of Traditional Chinese Medicine were selected, with 3 dropouts and 57 cases completed (29 in the experimental group and 28 in the control group). Baseline data: There were no statistically significant differences in age, sex, disease duration, baseline blood glucose, and hunger VAS scores between the two groups (P>0.05), making them comparable.

[0045] 4. Diagnostic criteria 4.1 Western Medicine Diagnostic Criteria: Those who meet the requirements of the "Guidelines for the Prevention and Treatment of Type II Diabetes in China (2025 Edition)" have a fasting blood glucose level ≥7.0 mmol / L or a 2-hour postprandial blood glucose level ≥11.1 mmol / L.

[0046] 4.2 Traditional Chinese Medicine Diagnostic Criteria: The syndrome is diagnosed as stomach heat and spleen deficiency, with phlegm and blood stasis.

[0047] Main symptoms: excessive hunger, heightened feeling of hunger, abdominal distension and fullness; Secondary symptoms: dry mouth, fatigue, heaviness in the limbs; Tongue and pulse: The tongue is red with a yellow, greasy coating, and the pulse is slippery and rapid.

[0048] 5. Discharge Standards 5.1 Inclusion criteria: 1. Meets the above diagnostic criteria of traditional Chinese medicine or Western medicine; 2. Age 18-75 years old; 3. Voluntarily participate in the research and sign an informed consent form; 4. Have not taken any traditional Chinese medicine compound prescriptions that affect appetite or glucose and lipid metabolism in the past month.

[0049] 5.2 Exclusion criteria: 1. Patients with type 1 diabetes, gestational diabetes, or secondary diabetes; 2. Individuals with severe cardiac, hepatic, renal, or hematopoietic system dysfunction; 3. Individuals allergic to any of the ingredients in this composition; 4. Individuals with mental illness who are unable to cooperate with the observation.

[0050] 6. Standards for shedding and rejection: 1. Cases found to be ineligible for inclusion after inclusion will be excluded; 2. Cases of dropout include those with poor compliance, those who experience serious adverse events, and those who withdraw voluntarily. 3. For cases that have fallen off, the final test must be completed, and the reasons for the falloff and the test results must be recorded in detail in the case report form.

[0051] 7. Treatment methods Experimental group: Basic hypoglycemic treatment (dietary control + exercise intervention + metformin) + the herbal composition of this invention, one dose per day, decocted in water and taken in two divided warm doses (or taken with Panax notoginseng powder), for a course of 12 weeks; Control group: Basic hypoglycemic treatment alone (dietary control + exercise intervention + metformin), for 12 weeks.

[0052] 8. Observation Indicators Subjective Appetite Assessment (VAS) score (100mm scale) Satiety, hunger, expected food intake, and overall appetite score; Calculation formula: Overall appetite score = ([100 - satiety] + [100 - satiety] + hunger + expected food intake) / 4.

[0053] Eating control assessment: The Control of Eating Questionnaire (CoEQ) was used to assess appetite control, food cravings, hunger, and satiety.

[0054] Glucose and lipid metabolism: fasting blood glucose, 2-hour postprandial blood glucose, triglycerides, and total cholesterol.

[0055] Body weight and body composition: weight, waist circumference, hip circumference, waist-to-hip ratio.

[0056] Traditional Chinese Medicine syndrome score: quantitative scoring of symptoms such as excessive hunger, abdominal distension and fullness, and dry mouth.

[0057] 9. Evaluation of therapeutic effect Table 1 Evaluation of therapeutic effects Research Results 10.1 VAS score The VAS (Visual Analog Scale) score is commonly used for pain rating and can also be widely used to quantify subjective hunger, satiety, and craving. In clinical diabetes, it is used to assess hunger due to hypoglycemia, hunger due to a controlled diet, and the effect of hypoglycemic drugs on suppressing appetite.

[0058] Table 2 VAS Scores As shown in Table 2, after 12 weeks of intervention, pathological hunger in both groups of diabetic patients improved. The total effective rate of VAS hunger improvement in the experimental group was 86.21%, significantly higher than that in the control group (64.29%), and the difference between the groups was statistically significant (P<0.05). This suggests that the herbal composition of the present invention can significantly improve the effect of pathological hunger in patients with type II diabetes, and is superior to simple basic hypoglycemic treatment.

[0059] 10.2 CoEQ Evaluation The CoEQ (Dietary Control Questionnaire) is specifically designed to assess the intensity and type of food cravings and the ability to control food intake. It is widely used in diabetes / weight loss research for evaluating hunger and appetite.

[0060] Table 3 CoEQ Scores As shown in Table 3, after 12 weeks of intervention, the food control ability of both groups of patients improved, and the total effective rate of CoEQ improvement in food control in the experimental group was significantly higher than that in the control group (P<0.05). This indicates that the traditional Chinese medicine composition of the present invention can effectively improve the food craving and food insufficiency in diabetic patients, and improve the pathogenesis of polyphagia from a behavioral perspective.

[0061] 10.3 Measurement of glucose and lipid metabolism indicators By measuring glucose and lipid metabolism indicators, the root cause of hunger can be identified, thereby achieving the goal of assisting in the regulation of blood glucose and blood lipid levels.

[0062] Table 4 Comparison of glucose and lipid metabolism indicators As shown in Table 4, there were no significant differences in fasting blood glucose, 2-hour postprandial blood glucose, triglycerides, and total cholesterol levels between the two groups before treatment (P>0.05), indicating comparable baseline levels. After 12 weeks of intervention, both groups showed significant improvements in glucose and lipid metabolism indicators compared to before treatment, with the experimental group showing significantly greater improvement than the control group (P<0.05). This indicates that the herbal composition of this invention can synergistically improve glucose and lipid metabolism disorders in patients with type 2 diabetes and help regulate blood glucose and lipid levels.

[0063] 10.4 Measurement of body weight and body composition In diabetic patients, weight and body composition directly affect insulin sensitivity, hormone secretion, and energy reserves, thereby regulating hunger, satiety, and appetite.

[0064] Table 5 Body weight and body composition As shown in Table 5, after 12 weeks of intervention, the weight, waist circumference, hip circumference, and waist-to-hip ratio of the experimental group were significantly lower than before treatment, and the improvement was significantly better than that of the control group (P<0.05). This suggests that the traditional Chinese medicine composition of the present invention can help improve body composition and central obesity in patients with type 2 diabetes.

[0065] 10.5 Evaluation of Traditional Chinese Medicine Syndrome Scores Traditional Chinese medicine syndrome scoring can objectively evaluate the severity of the TCM pathogenesis of hunger in diabetic patients, the differences in syndrome types, and the efficacy before and after treatment.

[0066] Table 6. Traditional Chinese Medicine Syndrome Scores As shown in Table 6, the TCM syndrome scores of both groups decreased after the intervention. The experimental group showed more significant improvement in symptoms such as excessive hunger, abdominal distension, and dry mouth (P<0.05), indicating that the present invention can significantly improve the core symptoms of diabetes such as stomach heat and spleen deficiency, and phlegm turbidity and blood stasis.

[0067] 11. Conclusion This invention's traditional Chinese medicine composition, combined with basic hypoglycemic therapy, can significantly suppress pathological hunger in patients with type II diabetes mellitus (stomach heat and spleen deficiency), and improve their ability to control food intake. Simultaneously, it synergistically lowers fasting and postprandial blood glucose, improves triglyceride and total cholesterol levels, reduces weight and central obesity, and alleviates traditional Chinese medicine symptoms such as excessive hunger, abdominal distension, and dry mouth. The overall efficacy is significantly superior to basic hypoglycemic therapy alone, with good safety profile, making it suitable for long-term intervention and management of metabolic disorders and hyperhungry symptoms in diabetes.

[0068] Example 3: Typical Clinical Cases Patient Zhang, male, 52 years old, visited the hospital in March 2025.

[0069] Chief complaint: 5-year history of type 2 diabetes, 3-year history of recurrent excessive hunger and hyperphagia, with poor blood sugar control.

[0070] Present illness: Oral metformin to lower blood sugar, fasting blood glucose 8.5-11.0 mmol / L, unbearable hunger 2-3 hours after meals, accompanied by abdominal distension, dry mouth and heaviness in the limbs.

[0071] Physical examination: red tongue with yellow and greasy coating, slippery and rapid pulse; fasting blood glucose 9.2 mmol / L, 2-hour postprandial blood glucose 13.5 mmol / L, triglycerides 2.8 mmol / L.

[0072] Traditional Chinese Medicine Diagnosis: Diabetes mellitus (stomach heat and spleen deficiency, phlegm and blood stasis syndrome).

[0073] Treatment: The herbal composition of this invention is combined with metformin for intervention, one dose per day, decocted in water and taken orally.

[0074] Efficacy: After 4 weeks of intervention, the VAS hunger score decreased by 65%, and the CoEQ eating control score improved significantly; after 12 weeks, hunger completely disappeared, fasting blood glucose was 6.8 mmol / L, 2-hour postprandial blood glucose was 9.1 mmol / L, triglycerides were 1.6 mmol / L, waist-to-hip ratio improved, all symptoms disappeared, and the condition remained stable in the long term.

[0075] Subjective Appetite Assessment (VAS) score (100mm scale) Note: The range from 0 to 100 indicates a gradual increase in the degree of sensation.

Claims

1. A traditional Chinese medicine composition, said traditional Chinese medicine composition comprising the following traditional Chinese medicines in parts by weight: Coptis chinensis slices 2-10 parts, Scutellaria baicalensis slices 5-12 parts, vinegar-processed Curcuma longa 2-15 parts, processed Pinellia ternata 5-12 parts, dried ginger 2-10 parts, Allium macrostemon 2-15 parts, Salvia miltiorrhiza 5-20 parts, Panax notoginseng 1-6 parts, and stir-fried Cassia tora 5-20 parts.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 4-8 parts of Coptis chinensis tablets, 8-10 parts of Scutellaria baicalensis tablets, 10-15 parts of vinegar-processed Curcuma longa, 5-12 parts of processed Pinellia ternata, 4-8 parts of dried ginger, 10-15 parts of Allium macrostemon, 12-18 parts of Salvia miltiorrhiza, 2-5 parts of Panax notoginseng, and 12-18 parts of Cassia tora.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 6 parts Coptis chinensis tablets, 9 parts Scutellaria baicalensis tablets, 12 parts vinegar-processed Curcuma longa, 9 parts processed Pinellia ternata, 6 parts dried ginger, 12 parts Allium macrostemon, 15 parts Salvia miltiorrhiza, 3 parts Panax notoginseng, and 15 parts stir-fried Cassia tora.

4. A traditional Chinese medicine preparation made from the traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine preparation is selected from one or more of the following: ointment, oral liquid, pill, decoction, tea, granule, capsule, tablet, powder and / or powder.

5. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The traditional Chinese medicine preparation is a decoction, and the preparation method of the decoction includes the following steps: S01: Prepare the Chinese herbal raw materials according to the required proportions; S02: Soak the Chinese herbal medicine raw materials prepared in S01; S03: Boil the raw materials and soaking liquid several times; S04: Combine the concentrated S03 solution to obtain the decoction described in this application.

6. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The soaking ratio of material to liquid is 1:10, and the soaking time is 20-30 minutes; the decocting is to first bring to a boil over low heat and then simmer over low heat for 60-120 minutes, and the decocting is performed a total of 3 times.

7. The traditional Chinese medicine preparation as described in claim 4, characterized in that, The traditional Chinese medicine preparation may contain pharmaceutically acceptable excipients, which are pharmaceutical excipients that enhance the efficacy, reduce toxicity, and / or alleviate the side effects of the main drug.

8. The use of the traditional Chinese medicine composition as described in claim 1 in a medicament for suppressing hunger in diabetic patients, characterized in that, Diabetes mellitus refers to a chronic metabolic disease caused by insulin resistance, blood glucose homeostasis imbalance, and chronic low-grade inflammation, with long-term elevated blood glucose as its core characteristic. Hunger is a subjective physiological craving mediated by the hypothalamus feeding center when the body's energy and nutrient intake is insufficient and blood glucose levels drop. It manifests as a strong desire to eat, which helps prompt individuals to eat and plays a role in regulating the body's homeostasis. Hunger in diabetic patients refers to a pathological hunger caused by disordered insulin secretion and the inability of glucose to enter cells normally for energy supply. Although the body's blood glucose is high, the cells are deficient in glucose, resulting in frequent fasting or premature hunger after meals. This is a pathological hunger caused by disordered glucose metabolism.

9. The application of the traditional Chinese medicine composition as described in claim 8 in a medicament for suppressing hunger in diabetic patients, characterized in that, The traditional Chinese medicine composition can be used in combination with other hypoglycemic drugs, including but not limited to metformin, dapagliflozin, and insulin.

Images