A weight-reducing traditional Chinese medicine preparation and a preparation method thereof

Abstract

The application discloses a weight-reducing traditional Chinese medicine preparation and a preparation method thereof. The weight-reducing traditional Chinese medicine preparation is prepared from radix puerariae, pericarpium citri reticulatae, coix seed, poria cocos, mulberry, dioscorea, lotus seed, prepared astragalus root and chenopodium quinoa. The weight-reducing traditional Chinese medicine preparation has the effects of invigorating the spleen and expelling dampness, nourishing yin and blood and calming the heart and soothing the nerves, is used for controlling weight and reducing fat, and is suitable for people with obesity.

Description

Field of Invention:

[0001] This invention relates to a traditional Chinese medicine preparation for weight loss and its preparation method, belonging to the field of pharmaceutical technology. Background Technology

[0002] Obesity is a common metabolic disorder. When the body consumes more calories than it burns, the excess calories are stored as fat. When this amount exceeds normal physiological needs and reaches a certain level, it develops into obesity. Normal adult males have 15%–18% body fat, while women have 20%–25%. The proportion of body fat increases with age. External factors primarily involve overeating and insufficient physical activity. Increased calorie intake exceeding calorie expenditure, leading to increased fat synthesis, is the material basis for obesity. Internal factors include disordered fat metabolism. Obesity is treated by controlling total food intake and engaging in appropriate exercise.

[0003] There are many ways to control weight, which generally include a healthy diet, appropriate exercise, good sleep, adequate water intake, mental health, and stress management. When controlling weight, try to choose healthy methods and avoid excessive dieting or taking oral weight-loss drugs. Common weight-loss drugs include orlistat, metformin tablets, and other similar medications. While long-term use of weight-loss drugs may result in a lower weight in the short term, it can also cause long-term health problems such as mood disorders, nutritional imbalances, nerve damage, and endocrine disorders. Furthermore, taking weight-loss drugs or dieting can lead to weight rebound.

[0004] The principle of Traditional Chinese Medicine (TCM) lies in addressing the root causes of illness by considering the different constitutions of individuals. It achieves its goal by simultaneously treating and regulating the body's systems. This invention emphasizes weight loss through regulating bodily functions. The medicines used in this invention are all food-grade medicinal materials that can strengthen the spleen and remove dampness, nourish yin and blood, and calm the mind and spirit, thereby achieving the goals of weight control and fat reduction. Its side effects are fewer and its safety profile is greater than that of Western medicine. Summary of the Invention

[0005] The technical problem to be solved by this invention is to provide a traditional Chinese medicine preparation for weight loss and its preparation method. This invention has the effects of strengthening the spleen and removing dampness, nourishing yin and blood, and calming the mind and soothing the nerves. It is used for weight control and fat reduction, and is suitable for obese individuals.

[0006] To solve the above technical problems, the present invention adopts the following technical solution:

[0007] A weight-loss traditional Chinese medicine preparation, the effective medicinal components of which are calculated by weight as follows: 100-200 parts of kudzu root, 100-200 parts of coix seed, 100-200 parts of poria cocos, 100-300 parts of mulberry, 50-150 parts of yam, 100-200 parts of lotus seed, 20-60 parts of roasted astragalus root, 25-75 parts of dried tangerine peel, and 100-300 parts of quinoa.

[0008] The aforementioned weight-loss Chinese medicine preparation contains the following active ingredients by weight: 120-180 parts of kudzu root, 120-180 parts of coix seed, 120-180 parts of poria cocos, 150-250 parts of mulberry, 80-120 parts of yam, 120-180 parts of lotus seed, 30-50 parts of roasted astragalus root, 40-60 parts of dried tangerine peel, and 150-250 parts of quinoa.

[0009] Specifically, the aforementioned weight-loss Chinese medicine preparation contains the following active ingredients by weight: 150 parts of kudzu root, 150 parts of coix seed, 150 parts of poria cocos, 200 parts of mulberry, 100 parts of yam, 150 parts of lotus seed, 40 parts of roasted astragalus root, 50 parts of dried tangerine peel, and 200 parts of quinoa.

[0010] The aforementioned method for preparing traditional Chinese medicine preparations for weight loss involves taking the herbs from the formula, combining them with acceptable excipients, and processing them according to conventional methods to produce the corresponding pharmaceutical preparations.

[0011] The aforementioned drug preparations are decoctions, pastes, hard capsules, tablets, or granules.

[0012] The aforementioned decoction is prepared as follows: Weigh all the medicinal materials in the formula according to the proportion, add 10 times the amount of water to soak for 0.5 hours, then decoct for 1 hour after boiling, filter, add 8 times the amount of water to the dregs, boil for 1 hour and take the decoction, mix the two decoctions, filter, and then concentrate to 45-55% of the original liquid, and then package to obtain the decoction.

[0013] The aforementioned decoction is prepared as follows: Weigh each medicinal material according to the prescription ratio, soak in 8 times the amount of water for 0.5 hours, then decoct for 1.5 hours after boiling, filter, add 6 times the amount of water to the dregs, boil for 1.5 hours, collect the decoction, mix the two decoctions, filter, and then concentrate until the relative density at 70℃ is 1.10-1.20. Take 30-35% of the weight of the above extract of refined honey, slowly add it to the above extract, stir evenly, continue to heat over low heat to reduce the paste, and when a small amount can be drawn into a thread or dripped onto paper without leaving water marks, seal it in a sterile bottle.

[0014] The aforementioned hard capsules are prepared as follows: Weigh each medicinal material according to the prescription ratio, soak in 8 times the amount of water for 0.5 hours, then decoct. After boiling for 2 hours, filter, add 6 times the amount of water to the residue, boil for 1 hour, and collect the decoction. Mix the two decoctions, filter, and then concentrate. The filtrate is concentrated to an extract with a relative density of 1.10-1.20 at 70℃. Dry the extract at 70℃, pulverize it into a fine powder, add 10% starch of the prepared amount and mix evenly. Granulate with 10% starch slurry, dry, granulate, and fill into capsules to obtain the final product.

[0015] The aforementioned tablets are prepared as follows: Weigh each medicinal material according to the prescription ratio, soak in 10 times the amount of water for 0.5 hours, then decoct. After boiling for 1 hour, filter, add 6 times the amount of water to the dregs, boil for 0.5 hours, and collect the decoction. Mix the two decoctions, filter, and then concentrate. Concentrate the filtrate to obtain an extract with a relative density of 1.10-1.20 at 70℃. Dry the extract at 70℃ and pulverize it into a fine powder to obtain a dry extract. Take the dry extract, mix it with 5% starch and 5% talc, granulate it using 75% ethanol as a wetting agent, dry it, compress it into tablets, and coat it with a film to obtain the final product.

[0016] The aforementioned granules are prepared as follows: Weigh each medicinal material according to the prescription ratio, soak in 10 times the amount of water for 0.5 hours, then decoct. After boiling for 1 hour, filter. Add 8 times the amount of water to the dregs, boil for 0.5 hours, and collect the decoction. Mix the two decoctions, filter, and then concentrate. Concentrate the filtrate to obtain an extract with a relative density of 1.10-1.20 at 70℃. Dry the extract at 70℃ and pulverize it into a fine powder to obtain a dry extract. Take 1 part of the dry extract and 1 part of dextrin, use 75% ethanol as a wetting agent to make granules. After making the granules, dry them at 70℃, pass them through a 12-mesh sieve once, and then separate the fine powder through an 80-mesh sieve to obtain the final product.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] The weight-loss traditional Chinese medicine preparation of this invention is prepared from kudzu root, tangerine peel, coix seed, poria cocos, mulberry, yam, lotus seed, roasted astragalus root, and quinoa. The properties and effects of each component are as follows:

[0019] Principal drug:

[0020] Job's tears are the dried, mature seeds of the grass Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf. They are cool in nature and sweet and bland in taste, possessing the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stopping diarrhea. Their ability to remove dampness and strengthen the spleen is particularly strong, aiming to eliminate dampness from the body, restore the spleen and stomach's digestive function, and fundamentally solve metabolic disorders and weight gain caused by dampness stagnation.

[0021] Kudzu root is the dried root of Pueraria lobata (Willd.) Ohwi, a plant in the legume family. It is cool in nature and has a sweet and pungent taste. It has the effects of relieving muscle tension and fever, raising yang and stopping diarrhea, and promoting body fluid and quenching thirst. It helps the spleen yang to transport and transform, raises clear yang, and strengthens the digestive function of the spleen and stomach. It is used together with coix seed as the principal medicine.

[0022] Minister's Medicine:

[0023] Poria cocos (Poria cocos Schw.) Wolf, a plant belonging to the Polyporaceae family, contains pine root-like material within its sclerotium. It is believed to have calming and soothing effects, as well as strengthening the spleen and removing dampness. It can both invigorate the spleen and promote digestion, and calm the mind, preventing dietary indiscretions caused by emotional distress.

[0024] Adjuvant:

[0025] Dried tangerine peel is the dried, mature peel of Citrus reticulata Blanco and its cultivated varieties, belonging to the Rutaceae family. It has a bitter and pungent taste and is warm in nature. It enters the lung and spleen meridians and has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It regulates the qi mechanism of the spleen and stomach and helps coix seed, Poria cocos, and other herbs to strengthen the spleen and remove dampness.

[0026] Mulberries are the mature fruit spikes of the mulberry tree (Morus alba Linn.), a plant of the Moraceae family. They are sweet and sour in taste and cold in nature. They enter the heart, liver, and kidney meridians. They have the effects of nourishing yin and blood, promoting body fluids and moisturizing dryness. They prevent excessive removal of dampness from damaging yin, while nourishing yin and blood to help metabolism.

[0027] Yam is the dried rhizome of Dioscorea opposita Thunb., a plant in the Dioscoreaceae family. It is sweet in taste and neutral in nature. It enters the spleen, lung, and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence. It also helps to strengthen the spleen and enhance the function of the spleen and stomach.

[0028] Lotus seeds are the dried, mature seeds of Nelumbo nucifera Gaertn., a plant in the Nymphaeaceae family. They are sweet and astringent in taste, and neutral in nature. They enter the spleen, kidney, and heart meridians. They have the effects of tonifying the spleen and stopping diarrhea, benefiting the kidneys and astringing essence, and nourishing the heart and calming the mind. They assist in strengthening the spleen and stopping diarrhea, nourishing the heart and calming the mind, and harmonizing the heart and spleen.

[0029] Used medicine:

[0030] Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. are processed products of the dried root of the legume Astragalus membranaceus (Fisch.) Bge. It is sweet in taste and warm in nature; it enters the lung and spleen meridians; it has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, and generating fluids and nourishing blood; when used in small amounts, it can tonify spleen qi, promote the circulation of qi and blood, and promote the metabolism of water and dampness.

[0031] Quinoa (Chenopodium quinoa Willd.) is a plant belonging to the genus Chenopodium in the family Chenopodiaceae; it is rich in nutrients, increases satiety, and reduces the intake of other foods.

[0032] Solution:

[0033] This formula uses Coix seed and kudzu root as the principal herbs to invigorate the spleen, promote diuresis, and restore the spleen and stomach's digestive function, ensuring the normal transformation and transportation of food and fluids, thus preventing the formation of dampness and phlegm, and helping to control weight. Poria cocos is used as the assistant herb to enhance spleen and stomach function and calm the mind. Tangerine peel, mulberry, yam, and lotus seed are used as adjuvant herbs, respectively regulating qi, nourishing yin, tonifying the spleen, stopping diarrhea, and nourishing the heart, working synergistically. Astragalus membranaceus (processed) and quinoa are used as guiding herbs to tonify qi and aid digestion. The entire formula works together to invigorate the spleen, eliminate dampness, nourish yin and blood, and calm the mind, thereby achieving the goal of weight control and fat reduction, suitable for obese individuals.

[0034] Instruction manual illustrations

[0035] Figure 1 Record the changes in body weight, skeletal muscle mass, body fat mass, body fat percentage, and extracellular water ratio in typical case 1;

[0036] Figure 2 Record of changes in lower limb muscle mass, BMI, basal metabolic rate, and waist-to-hip ratio in typical case 1;

[0037] Figure 3 Record of changes in visceral fat area in typical case 1;

[0038] Figure 4 Record the changes in body weight, skeletal muscle mass, body fat mass, body fat percentage, and extracellular water ratio in typical case 2;

[0039] Figure 5 Record of changes in lower limb muscle mass, BMI, basal metabolic rate, and waist-to-hip ratio in typical case 2;

[0040] Figure 6 Record of changes in visceral fat area in typical case 2;

[0041] Figure 7 Record the changes in body weight, skeletal muscle mass, body fat mass, body fat percentage, and extracellular water ratio in typical case 3;

[0042] Figure 8 Record of changes in lower limb muscle mass, BMI, basal metabolic rate, and waist-to-hip ratio in typical case 3;

[0043] Figure 9 Record of changes in visceral fat area in typical case 3;

[0044] Figure 10 Record the changes in body weight, skeletal muscle mass, body fat mass, body fat percentage, and extracellular water ratio in typical case 4;

[0045] Figure 11 Record of changes in lower limb muscle mass, BMI, basal metabolic rate, and waist-to-hip ratio in typical case 4;

[0046] Figure 12 Record of changes in visceral fat area in typical case 4;

[0047] Figure 13 Record the changes in weight, skeletal muscle mass, body fat mass, body fat percentage, and extracellular water ratio in typical case 5;

[0048] Figure 14 Record of changes in lower limb muscle mass, BMI, basal metabolic rate, and waist-to-hip ratio in typical case 5;

[0049] Figure 15 Record of changes in visceral fat area in typical case 5;

[0050] Figure 16 Record the changes in body weight, skeletal muscle mass, body fat mass, body fat percentage, and extracellular water ratio in typical case 6;

[0051] Figure 17 Record of changes in lower limb muscle mass, BMI, basal metabolic rate, and waist-to-hip ratio in typical case 6;

[0052] Figure 18 Record of changes in visceral fat area in typical case 6. Detailed Implementation

[0053] The present invention will be further described below with reference to embodiments, but these embodiments are not intended to limit the scope of the invention.

[0054] Example 1.

[0055] Prescription: 150g kudzu root, 150g coix seed, 150g poria cocos, 200g mulberry, 100g yam, 150g lotus seed, 40g roasted astragalus root, 50g dried tangerine peel, 200g quinoa.

[0056] Process: Weigh all the medicinal materials in the formula according to the proportion, soak them in 10 times the amount of water for 0.5 hours, then decoct them. After boiling for 1 hour, filter them, add 8 times the amount of water to the dregs, boil for 1 hour, and take the decoction. Mix the two decoctions, filter them, and then concentrate them to 50% of the original liquid. Package them to obtain the water decoction.

[0057] Dosage and administration: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0058] Example 2.

[0059] Prescription: 200g kudzu root, 200g coix seed, 100g poria cocos, 100g mulberry, 50g yam, 200g lotus seed, 60g roasted astragalus root, 25g dried tangerine peel, 100g quinoa.

[0060] Process: Weigh each medicinal material according to the prescription ratio, soak in 8 times the amount of water for 0.5 hours, then decoct for 1.5 hours after boiling. Filter, add 6 times the amount of water to the dregs, boil for 1.5 hours, and collect the decoction. Mix the two decoctions, filter, and then concentrate until the relative density at 70℃ is 1.10-1.20. Take 30-35% of the weight of the above extract of refined honey, slowly add it to the above extract, stir evenly, and continue to heat over low heat to reduce the paste. When a small amount can be drawn into a thread or dripped onto paper without leaving water marks, seal it in a sterile bottle to obtain the decoction.

[0061] Dosage and administration: Take 30-40g at lunch and 15-20g at dinner, replacing rice as a staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0062] Example 3.

[0063] Prescription: 100g kudzu root, 100g coix seed, 200g poria cocos, 300g mulberry, 150g yam, 100g lotus seed, 20g roasted astragalus root, 75g dried tangerine peel, 300g quinoa.

[0064] Process: Weigh each medicinal material according to the prescription ratio, soak in 8 times the amount of water for 0.5 hours, then decoct. After boiling for 2 hours, filter, add 6 times the amount of water to the dregs, boil for 1 hour, and collect the decoction. Mix the two decoctions, filter, and then concentrate. The filtrate is concentrated to an extract with a relative density of 1.10-1.20 at 70℃. Dry at 70℃ to obtain a dry extract, pulverize into a fine powder, add 10% starch of the prepared amount and mix evenly. Granulate with 10% starch slurry, dry, granulate, and fill into capsules to obtain hard capsules.

[0065] Dosage and administration: Take 6-10g at lunch and 3-5g at dinner, replacing rice as a staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0066] Example 4.

[0067] Prescription: 180g kudzu root, 120g coix seed, 200g poria cocos, 220g mulberry, 80g yam, 180g lotus seed, 55g roasted astragalus root, 35g dried tangerine peel, 200g quinoa.

[0068] Process: Weigh each medicinal material according to the prescription ratio, soak in 10 times the amount of water for 0.5 hours, then decoct. After boiling for 1 hour, filter. Add 6 times the amount of water to the dregs, boil for 0.5 hours, and collect the decoction. Mix the two decoctions, filter, and then concentrate. Concentrate the filtrate to obtain an extract with a relative density of 1.10-1.20 at 70℃. Dry the extract at 70℃ and pulverize it into a fine powder to obtain a dry extract. Take the dry extract, mix it with 5% starch and 5% talc, granulate it using 75% ethanol as a wetting agent, dry it, compress it into tablets, and coat it with a film to obtain tablets.

[0069] Dosage and administration: Take 6-10g at lunch and 3-5g at dinner, replacing rice as a staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0070] Example 5.

[0071] Prescription: 130g kudzu root, 100g coix seed, 150g poria cocos, 200g mulberry, 60g yam, 170g lotus seed, 50g roasted astragalus root, 20g dried tangerine peel, 120g quinoa.

[0072] Process: Weigh each medicinal material according to the prescription ratio, add 10 times the amount of water and soak for 0.5 hours, then decoct. After boiling for 1 hour, filter. Add 8 times the amount of water to the dregs, boil for 0.5 hours, and collect the decoction. Mix the two decoctions, filter, and then concentrate. Concentrate the filtrate to obtain an extract with a relative density of 1.10-1.20 at 70℃. Dry the extract at 70℃ and pulverize it into a fine powder to obtain a dry extract. Take 1 part of the dry extract and 1 part of dextrin, use 75% ethanol as a wetting agent to make granules. After making the granules, dry them at 70℃, pass them through a 12-mesh sieve once, and then separate the fine powder through an 80-mesh sieve to obtain granules.

[0073] Dosage and administration: Take 30-40g at lunch and 15-20g at dinner, replacing rice as a staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0074] Example 6.

[0075] Prescription: 150g kudzu root, 170g coix seed, 120g poria cocos, 250g mulberry, 85g yam, 160g lotus seed, 50g roasted astragalus root, 45g dried tangerine peel, 300g quinoa.

[0076] Process: Weigh all the medicinal materials in the formula according to the proportion, soak them in 12 times the amount of water for 0.5 hours, then decoct them. After boiling for 1 hour, filter them, add 6 times the amount of water to the dregs, boil for 1 hour, and then take the decoction. Mix the two decoctions, filter them, and then concentrate them to 45% of the original liquid. Then, package them to obtain the water decoction.

[0077] Dosage and administration: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0078] Example 7.

[0079] Prescription: 120g kudzu root, 140g coix seed, 170g poria cocos, 120g mulberry, 115g yam, 120g lotus seed, 40g roasted astragalus root, 65g dried tangerine peel, 200g quinoa.

[0080] Process: Weigh all the medicinal materials in the formula according to the proportion, soak them in 12 times the amount of water for 0.5 hours, then decoct them. After boiling for 1 hour, filter them, add 6 times the amount of water to the dregs, boil for 1 hour, and then take the decoction. Mix the two decoctions, filter them, and then concentrate them to 55% of the original liquid. Then, package them to obtain the water decoction.

[0081] Dosage and administration: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0082] To verify the beneficial effects of this invention, the inventors conducted relevant clinical trials and experimental studies. The experimental process and results are as follows:

[0083] 1 Clinical study

[0084] 1.1 Source of Cases

[0085] This study is a real-world observational study, with cases from 97 overweight and obese patients who visited the Qiannan Buyi and Miao Autonomous Prefecture Traditional Chinese Medicine Hospital between June 2023 and July 2024.

[0086] 1.2 Diagnostic criteria

[0087] 1.2.1 Western Medicine Diagnostic Criteria:

[0088] The Western medicine diagnostic criteria were based on the "Consensus on Multidisciplinary Diagnosis and Treatment of Obesity Based on Clinical Practice (2021 Edition)" (Chinese Medical Association Endocrinology Branch, Chinese Association of Traditional Chinese Medicine Diabetes Branch, Chinese Medical Doctor Association Surgical Branch Obesity and Diabetes Surgery Committee, etc.). [J]. Chinese Journal of Digestive Surgery, 2021, 20(11):16. BMI 24.0-27.9 kg / m² was considered. 2 Defined as overweight, BMI > 28.0 kg / m² 2 Defined as obesity.

[0089] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria:

[0090] Referencing the second edition of the Advanced Series on Traditional Chinese Medicine, *Internal Medicine of Traditional Chinese Medicine* (Wang Yongyan, Lu Zhaolin. *Internal Medicine of Traditional Chinese Medicine* [M]. Beijing: People's Medical Publishing House, 2018: 816):

[0091] (1) If the measured weight exceeds the standard weight by 10%-19%, it is considered overweight; if it exceeds 20%, it is considered obese; if it exceeds 20%-30%, it is considered mildly obese; if it exceeds 30%-50%, it is considered moderately obese; and if it exceeds 50%, it is considered severely obese.

[0092] (2) It may be accompanied by a variety of symptoms such as fatigue, shortness of breath, drowsiness, increased appetite, easy hunger, or amenorrhea, impotence, palpitations, heat intolerance and excessive sweating, back pain, joint pain, etc.

[0093] (3) Body fat measurement: Men with more than 25% body fat and women with more than 30% body fat are considered obese. Fat cell measurement: Increased number of fat cells; ultrasound examination shows increased subcutaneous fat thickness.

[0094] 1.2.3 Traditional Chinese Medicine Syndrome Differentiation Standards

[0095] Formulated with reference to the 2nd edition of Advanced Series on Traditional Chinese Medicine, *Internal Medicine of Traditional Chinese Medicine* (Wang Yongyan, Lu Zhaolin. *Internal Medicine of Traditional Chinese Medicine* [M]. Beijing: People's Medical Publishing House, 2018: 816):

[0096] ①Spleen deficiency with phlegm retention syndrome: Symptoms, tongue and pulse: obesity and bloating, fatigue and weakness, epigastric and abdominal distension, heaviness in the head and body, puffy eyelids, or lower limb edema, pale or swollen tongue, white and greasy or white and slippery coating, and soft and slow pulse.

[0097] ② Damp-heat syndrome: Symptoms, tongue and pulse: Obese body, greasy and dry mouth, thirst but no desire to drink, or discomfort after drinking, abdominal distension and fullness, dry stool or loose and sticky stool with foul odor, red tongue with yellow and greasy coating, and soft and rapid or slippery and rapid pulse.

[0098] ③ Damp-heat syndrome of liver and gallbladder: Symptoms, tongue and pulse: obesity and excessive eating, bitter taste in the mouth, poor appetite, nausea and vomiting, abdominal distension and fullness, hypochondriac pain, red tongue, yellow and greasy coating, and wiry and rapid pulse.

[0099] ④ Liver and Kidney Yin Deficiency Syndrome: Symptoms, tongue, and pulse: Obesity, dull and lackluster skin, blurred vision, dizziness, tinnitus, dry and bitter mouth, soreness and weakness in the lower back and knees, headache, irritability, numbness in the limbs, red tongue with little or no coating, and a thready and rapid pulse. ⑤ Qi Stagnation and Blood Stasis Syndrome: Symptoms, tongue, and pulse: Obesity, lethargy, frequent sighing, chest tightness and fullness in the hypochondrium, dull complexion and dark lips, dull or even bluish-purple discoloration of the extremities, possibly accompanied by constipation, insomnia, decreased libido or even impotence in men, and irregular menstruation, scanty menstruation or even amenorrhea in women, with dark menstrual blood or blood clots; dark tongue or petechiae, thin tongue coating, and a wiry or hesitant pulse.

[0100] 1.3 Inclusion Criteria

[0101] ① According to the diagnostic criteria for overweight in Western medicine, BMI (Body Mass Index) ≥ 24 kg / m² 2and BMI (Body Mass Index) ≥ 28.0 kg / m² 2 The person.

[0102] ② Those who meet the above-mentioned TCM diagnostic criteria, and also meet the above-mentioned TCM diagnostic criteria for spleen deficiency and phlegm retention syndrome, damp-heat retention syndrome, liver and gallbladder damp-heat syndrome, liver and kidney yin deficiency syndrome, and qi stagnation and blood stasis syndrome.

[0103] ③Those who voluntarily join this clinical study, comply with the requirements of this trial, and can follow the doctor's orders to take medication and complete this study.

[0104] ④ Age 18-45 years old.

[0105] 1.4 Exclusion Criteria

[0106] ① Suffering from serious diseases of the heart, liver, kidneys, or other organs;

[0107] ②Pregnant or breastfeeding women;

[0108] ③ You are currently using other weight loss medications or undergoing weight loss treatment;

[0109] ④ Individuals allergic to any of the Chinese herbal ingredients used in this study.

[0110] 1.4 Methods

[0111] 1.4.1 Baseline Data Acquisition

[0112] (1) When patients are enrolled, their basic information is recorded in detail, including age, gender, height, weight, abdominal circumference, visceral fat grade, visceral fat area, body fat, BMI, etc.

[0113] (2) Inquire about the patient's medical history, dietary habits, exercise, family history of obesity, etc.

[0114] 1.4.2 Treatment Plan

[0115] Prescription: 150g kudzu root, 150g coix seed, 150g poria cocos, 200g mulberry, 100g yam, 150g lotus seed, 40g roasted astragalus root, 50g dried tangerine peel, 200g quinoa.

[0116] Process: Weigh all the medicinal materials in the formula according to the proportion, soak them in 10 times the amount of water for 0.5 hours, then decoct them. After boiling for 1 hour, filter them, add 8 times the amount of water to the dregs, boil for 1 hour, and take the decoction. Mix the two decoctions, filter them, and then concentrate them to 50% of the original liquid. Package them to obtain the water decoction.

[0117] Dosage and administration: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0118] 1.4.3 Follow-up and Data Collection

[0119] (1) During the treatment period, patients should be followed up regularly to record changes in indicators such as weight, abdominal circumference, visceral fat grade, visceral fat area, body fat, and BMI.

[0120] (2) Inquire about the patient's diet, exercise, and any adverse reactions during treatment.

[0121] 1.4.4 Study Endpoint

[0122] (1) Primary endpoint: Changes in patient weight after 1 month of treatment.

[0123] (2) Secondary endpoints: Changes in abdominal circumference, visceral fat grade, visceral fat area, body fat, BMI and other indicators after 1 month of treatment.

[0124] 1.4.5 Data Management and Statistical Analysis

[0125] (1) Establish a dedicated database to input, manage and back up research data.

[0126] (2) Statistical analysis was performed using SPSS 26.0. The Shapiro-Wilk test was used to explore the data distribution. One-way ANOVA was used to determine if the data followed a normal distribution, and the Dunnett-t test was used for post-hoc multiple comparisons. Independent samples nonparametric tests were used to determine if the data did not follow a normal distribution. P < 0.05 was considered statistically significant.

[0127] 1.4.6 Quality Control

[0128] (1) Researchers receive standardized training before data collection to ensure the accuracy and consistency of the data collection.

[0129] (2) Regularly check the quality of the data and correct any problems in a timely manner.

[0130] (3) Strictly follow the research plan to ensure the scientific nature and standardization of the research.

[0131] 1.4.7 Median Calculation Method

[0132] The median is unaffected by extreme values ​​and reflects the middle level of a set of data well. In some cases, it is more representative of the general situation of the data than the mean.

[0133] 1.4.7.1 When the number of data is odd, arrange the data from smallest to largest, and the middle number is the median.

[0134] For example: 1, 2, 3, 4, 5, the median is 3.

[0135] 1.4.7.2 When the number of data is even, arrange the data in ascending order and take the average of the two middle numbers as the median.

[0136] For example: 1, 2, 3, 4, 5, 6, the middle two numbers are 3 and 4, the median is (3+4)÷2=3.5.

[0137] 1.5 Results

[0138] 1.5.1 Analysis of Waist Circumference Results

[0139] One month after the intervention, the waist circumference decreased significantly compared with the baseline, and the difference was statistically significant (P<0.05). Specific results are shown in Table 1.

[0140] Table 1 Comparison of waist circumference results

[0141]

[0142] 1.5.2 Analysis of Visceral Fat Grading Results

[0143] One month after the intervention, compared with baseline, the visceral fat grade was significantly reduced, and the difference was statistically significant (P<0.05). Specific results are shown in Table 2.

[0144] Table 2 Comparison of Visceral Fat Grades

[0145]

[0146] 1.5.3 Analysis of Visceral Fat Area Results

[0147] One month after the intervention, the visceral fat area was significantly reduced compared with the baseline, and the difference was statistically significant (P<0.05). Specific results are shown in Table 3.

[0148] Table 3 Comparison of visceral fat area

[0149]

[0150] 1.5.4 Analysis of Body Weight Results

[0151] One month after the intervention, body weight decreased significantly compared with baseline, and the difference was statistically significant (P<0.05). Specific results are shown in Table 4.

[0152] Table 4 Comparison of Weight Results

[0153]

[0154] 1.5.5 Analysis of Body Fat Results

[0155] One month after the intervention, body fat decreased significantly compared with baseline, and the difference was statistically significant (P<0.05). Specific results are shown in Table 5.

[0156] Table 5 Comparison of body fat percentage

[0157]

[0158] 1.5.6 BMI Result Analysis

[0159] One month after the intervention, BMI decreased significantly compared with baseline, and the difference was statistically significant (P<0.05). Specific results are shown in Table 6.

[0160] Table 6 BMI Comparison

[0161]

[0162] 1.5.7 Conclusion:

[0163] One month after the intervention, waist circumference, body fat and BMI decreased significantly.

[0164] 2. Typical Cases

[0165] 2.1 Typical Case 1:

[0166] Name: Mo Moumou.

[0167] Gender: Female; Age: 33; Date of visit: November 14, 2023.

[0168] Chief complaint: Gradual weight gain over 2 years.

[0169] Present illness: Over the past two years, the patient has been gaining weight, feeling heavy, and easily fatigued after activity.

[0170] Symptoms: obesity, heaviness in the limbs, fatigue, loss of appetite, abdominal distension, and loose stools.

[0171] Physical characteristics: Height 170cm, weight 75kg, BMI 26, body fat 31.2kg. Tongue pale and swollen with teeth marks on the edges, white and greasy coating, and a soft and slow pulse.

[0172] Traditional Chinese Medicine (TCM) etiology analysis: The patient's constitution is inherently weak, and improper diet damages the spleen and stomach. As a result, the spleen loses its ability to transform and transport fluids, leading to the accumulation of dampness and the generation of phlegm, which in turn causes obesity.

[0173] Past medical history: No special past medical history.

[0174] Family history: No family history of obesity.

[0175] Diagnosis by both Traditional Chinese Medicine and Western Medicine: Traditional Chinese Medicine diagnosed it as obesity; Western Medicine diagnosed it as simple obesity.

[0176] Syndrome type: Spleen deficiency with phlegm retention.

[0177] Traditional Chinese Medicine Diet Recipe: Take 15g of kudzu root, 15g of coix seed, 15g of poria cocos, 20g of mulberry, 10g of yam, 15g of lotus seed, 4g of roasted astragalus root, 5g of dried tangerine peel, and 20g of quinoa. Soak in 10 times the amount of water for 0.5 hours, then decoct. After boiling for 1 hour, filter. Add 8 times the amount of water to the dregs, boil for 1 hour, and collect the decoction. Mix the two decoctions, filter, and then concentrate to 50% of the original liquid. Package into portions.

[0178] Dosage: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0179] Follow-up visit: November 28, 2024. Fatigue and abdominal distension have lessened, weight has dropped to 73.2 kg, BMI is 25.3, and body fat is 29.4 kg.

[0180] Follow-up medicinal diet: The original prescription and preparation method remain unchanged.

[0181] Dosage: Same as before.

[0182] Patient prognosis and outcome: With continued adherence to medicinal diet therapy and appropriate exercise, the patient's weight further decreased, and the symptoms of spleen deficiency and phlegm retention gradually improved. On April 22, 2024, the patient's weight dropped to 67.2 kg, BMI was 23.3, and body fat was 24.4 kg.

[0183] 2.2 Typical Case 2:

[0184] Name: Zhang Moumou.

[0185] Gender: Male; Age: 45; Date of consultation: November 20, 2023.

[0186] Chief complaint: Obesity accompanied by bitter taste and halitosis for 1 year.

[0187] Present illness: Significant weight gain over the past year, accompanied by bitter taste in the mouth, halitosis, sticky stools, and dark yellow urine.

[0188] Symptoms: Obesity, bitter taste in the mouth, bad breath, irritability, sticky and unsatisfactory bowel movements, and dark and scanty urine.

[0189] Physical characteristics: Height 163cm, weight 97.2kg, BMI 36.6, body fat 41.2kg. Tongue red with yellow greasy coating, pulse slippery and rapid.

[0190] Traditional Chinese medicine etiology analysis: Long-term overconsumption of rich and fatty foods leads to the generation of damp heat. The accumulation of damp heat obstructs the spleen and stomach's function of digestion and absorption, resulting in obesity.

[0191] Past medical history: Hyperlipidemia for 3 years.

[0192] Family history: Father has a history of hypertension.

[0193] Diagnosis by both Traditional Chinese Medicine and Western Medicine: Traditional Chinese Medicine diagnosed it as obesity; Western Medicine diagnosed it as simple obesity.

[0194] Syndrome type: Damp-heat retention syndrome.

[0195] Traditional Chinese Medicine Diet Recipe: Take 15g of kudzu root, 15g of coix seed, 15g of poria cocos, 20g of mulberry, 10g of yam, 15g of lotus seed, 4g of roasted astragalus root, 5g of dried tangerine peel, and 20g of quinoa. Soak in 10 times the amount of water for 0.5 hours, then decoct. After boiling for 1 hour, filter. Add 8 times the amount of water to the dregs, boil for 1 hour, and collect the decoction. Mix the two decoctions, filter, and then concentrate to 50% of the original liquid. Package into portions.

[0196] Dosage: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0197] Follow-up visit: December 16, 2023. Bitter taste and bad breath have lessened, bowel movements are more regular, weight has decreased to 92.3 kg, BMI has decreased to 34.7, and body fat has decreased to 37.3 kg.

[0198] Follow-up medicinal diet: The original prescription and preparation method remain unchanged.

[0199] Dosage: Same as before.

[0200] Patient prognosis and outcome: With treatment and dietary adjustments, the symptoms of damp-heat gradually disappear, and weight is expected to gradually decrease.

[0201] 2.3 Typical Case 3:

[0202] Name: Zhang.

[0203] Gender: Female; Age: 36; Date of visit: January 18, 2024.

[0204] Chief complaint: Obesity accompanied by distending pain in the hypochondrium for six months.

[0205] Present illness: Weight gain, rib pain, irritability, and bitter taste in the mouth over the past six months.

[0206] Symptoms: obesity, rib pain, irritability, bitter taste in the mouth, and irregular menstruation.

[0207] Physical characteristics: Height 160cm, weight 75.8kg, BMI 29.6, body fat 32.7kg. Tongue red with yellow greasy coating, pulse wiry and rapid.

[0208] Traditional Chinese Medicine (TCM) etiology analysis: Emotional distress leads to liver qi stagnation, which over time transforms into heat, resulting in internal accumulation of damp-heat in the liver and gallbladder, affecting the spleen and stomach's digestive function and causing obesity.

[0209] Past medical history: No special past medical history.

[0210] Family history: Mother has a history of cholecystitis.

[0211] Diagnosis by both Traditional Chinese Medicine and Western Medicine: Traditional Chinese Medicine diagnosed it as obesity; Western Medicine diagnosed it as simple obesity.

[0212] Syndrome type: Damp-heat syndrome of the liver and gallbladder.

[0213] Traditional Chinese Medicine Diet Recipe: Take 15g of kudzu root, 15g of coix seed, 15g of poria cocos, 20g of mulberry, 10g of yam, 15g of lotus seed, 4g of roasted astragalus root, 5g of dried tangerine peel, and 20g of quinoa. Soak in 10 times the amount of water for 0.5 hours, then decoct. After boiling for 1 hour, filter. Add 8 times the amount of water to the dregs, boil for 1 hour, and collect the decoction. Mix the two decoctions, filter, and then concentrate to 50% of the original liquid. Package into portions.

[0214] Dosage: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0215] Follow-up visit: March 5, 2024. The pain in the hypochondriac region has lessened, the irritability has improved, the weight has dropped to 73.2 kg, the BMI is 28.6, and the body fat has dropped to 31.8 kg.

[0216] Follow-up medicinal diet: The original prescription and preparation method remain unchanged.

[0217] Dosage: Same as before.

[0218] Patient prognosis and outcome: With continued treatment, the symptoms of damp-heat in the liver and gallbladder were further relieved, and the patient's weight continued to decrease. On July 31, 2024, the patient's weight dropped to 70.7 kg, the BMI was 27.6, and the body fat was reduced to 28 kg.

[0219] 2.4 Typical Case 4:

[0220] Name: Dai Moumou.

[0221] Gender: Female; Age: 33; Date of visit: March 7, 2024.

[0222] Chief complaint: Obesity accompanied by dizziness and tinnitus for 2 years.

[0223] Present illness: Weight gain over the past 2 years, accompanied by dizziness, tinnitus, soreness and weakness in the lower back and knees, and hot flashes in the palms, soles, and chest.

[0224] Symptoms: obesity, dizziness, tinnitus, lower back and knee weakness, insomnia and excessive dreaming.

[0225] Physical characteristics: Height 162cm, weight 64.9kg, BMI 24.7, body fat 25.7kg. Tongue red with little coating, pulse thready and rapid.

[0226] Traditional Chinese medicine etiology analysis: Prolonged illness and physical weakness, or excessive sexual activity, deplete the yin of the liver and kidneys, leading to yin deficiency and excessive fire, which burns body fluids and turns into phlegm, resulting in obesity.

[0227] Past medical history: Hypertension for 5 years.

[0228] Family history: No family history of obesity.

[0229] Diagnosis by both Traditional Chinese Medicine and Western Medicine: Traditional Chinese Medicine diagnosed it as obesity; Western Medicine diagnosed it as simple obesity.

[0230] Syndrome type: Liver and kidney yin deficiency syndrome.

[0231] Traditional Chinese medicine dietary therapy:

[0232] Take 15g of kudzu root, 15g of coix seed, 15g of poria cocos, 20g of mulberry, 10g of yam, 15g of lotus seed, 4g of roasted astragalus root, 5g of dried tangerine peel, and 20g of quinoa. Soak them in 10 times the amount of water for 0.5 hours, then decoct them. After boiling for 1 hour, filter. Add 8 times the amount of water to the dregs, boil for 1 hour, and collect the decoction. Mix the two decoctions, filter, and then concentrate to 50% of the original liquid. Package the mixture.

[0233] Dosage: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0234] Follow-up visit: March 29, 2024. Dizziness and tinnitus lessened, lower back and knee pain improved, sleep improved, weight decreased to 62.4 kg, BMI decreased to 23.8, and body fat decreased to 24.9 kg.

[0235] Follow-up medicinal diet: The original prescription and preparation method remain unchanged.

[0236] Dosage: Same as before.

[0237] Patient prognosis and outcome: With continued treatment and dietary therapy, the symptoms of liver and kidney yin deficiency gradually improved, and the patient's weight steadily decreased. On May 30, 2024, the weight dropped to 60.2 kg, the BMI decreased to 22.9, and the body fat decreased to 23.7 kg (see details). Figures 10-12 ).

[0238] 2.5 Typical Case 5:

[0239] Name: Chen Moumou.

[0240] Gender: Female; Age: 31; Date of visit: May 7, 2024.

[0241] Chief complaint: Obesity accompanied by chest and rib distension and irregular menstruation for 1 year.

[0242] Present illness: Weight gain, chest and rib distension, irritability, irregular menstruation, dark purple menstrual blood with clots for the past year.

[0243] Symptoms: obesity, chest and rib distension, irritability, irregular menstruation, dark purple menstrual blood.

[0244] Physical characteristics: Height 155cm, weight 65.7kg, BMI 27.3, body fat 25.5kg. Tongue is dark purple with petechiae, pulse is wiry and hesitant.

[0245] Traditional Chinese Medicine (TCM) etiology analysis: Emotional distress, stagnation of liver qi, poor qi circulation, and blood stasis lead to obesity.

[0246] Past medical history: No special past medical history.

[0247] Family history: No family history of obesity.

[0248] Diagnosis by both Traditional Chinese Medicine and Western Medicine: Traditional Chinese Medicine diagnosed it as obesity; Western Medicine diagnosed it as simple obesity.

[0249] Syndrome type: Qi stagnation and blood stasis syndrome.

[0250] Traditional Chinese Medicine Diet Recipe: Take 15g of kudzu root, 15g of coix seed, 15g of poria cocos, 20g of mulberry, 10g of yam, 15g of lotus seed, 4g of roasted astragalus root, 5g of dried tangerine peel, and 20g of quinoa. Soak in 10 times the amount of water for 0.5 hours, then decoct. After boiling for 1 hour, filter. Add 8 times the amount of water to the dregs, boil for 1 hour, and collect the decoction. Mix the two decoctions, filter, and then concentrate to 50% of the original liquid. Package into portions.

[0251] Dosage: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0252] Follow-up visit: June 4, 2024. Chest and rib fullness has lessened, menstrual cycle has improved, weight has decreased to 62.4 kg, BMI has decreased to 26, and body fat has decreased to 23.9 kg.

[0253] Follow-up medicinal diet: The original prescription and preparation method remain unchanged.

[0254] Dosage: Same as before.

[0255] Patient prognosis and outcome: With the progress of treatment and emotional adjustment, the symptoms of qi stagnation and blood stasis improved, and the weight continued to decrease. On June 25, 2024, the weight dropped to 61kg, the BMI dropped to 25.4, and the body fat dropped to 22.2kg.

[0256] 2.6 Typical Case 6:

[0257] Name: Zhang Moumou.

[0258] Gender: Female; Age: 49; Date of visit: May 31, 2024.

[0259] Chief complaint: Obesity accompanied by fatigue and chest tightness for 2 years.

[0260] Present illness: Gradual weight gain over the past 2 years, accompanied by fatigue, chest tightness, excessive phlegm, and poor appetite.

[0261] Symptoms: obesity, fatigue, chest tightness, excessive phlegm, and poor appetite.

[0262] Physical characteristics: Height 160cm, weight 72.8kg, BMI 28.4, body fat 30.4kg. Pale and swollen tongue with a white and greasy coating, and a soft and slow pulse.

[0263] Traditional Chinese Medicine (TCM) etiology analysis: Insufficient congenital endowment and weak spleen qi, coupled with improper diet, damage to the spleen and stomach, leading to the internal generation of dampness and phlegm, resulting in obesity.

[0264] Past medical history: No special past medical history.

[0265] Family history: Father has obesity.

[0266] Diagnosis by both Traditional Chinese Medicine and Western Medicine: Traditional Chinese Medicine diagnosed it as obesity; Western Medicine diagnosed it as simple obesity.

[0267] Syndrome type: Spleen deficiency with phlegm retention.

[0268] Traditional Chinese Medicine Diet Recipe: Take 15g of kudzu root, 15g of coix seed, 15g of poria cocos, 20g of mulberry, 10g of yam, 15g of lotus seed, 4g of roasted astragalus root, 5g of dried tangerine peel, and 20g of quinoa. Soak in 10 times the amount of water for 0.5 hours, then decoct. After boiling for 1 hour, filter. Add 8 times the amount of water to the dregs, boil for 1 hour, and collect the decoction. Mix the two decoctions, filter, and then concentrate to 50% of the original liquid. Package into portions.

[0269] Dosage: Take 100-150mL at lunch and 40-60mL at dinner, replacing rice as the staple food. Vegetables, meat, eggs, milk, and low-GI fruits can be consumed normally.

[0270] Follow-up visit: July 18, 2024. Fatigue and chest tightness have lessened, weight has decreased to 64.6 kg, BMI has decreased to 25.2, and body fat has decreased to 24.4 kg.

[0271] Follow-up medicinal diet: The original prescription and preparation method remain unchanged.

[0272] Dosage: Same as before.

[0273] Patient prognosis and outcome: With continued treatment, combined with a reasonable diet and exercise, the symptoms of spleen deficiency and phlegm retention further improved, and the patient's weight gradually decreased. On August 17, 2024, the patient's weight dropped to 64.6 kg, BMI dropped to 25.2, and body fat dropped to 24.4 kg.

Claims

1. A traditional Chinese medicine preparation for weight loss, characterized in that: Its medicinal active ingredients, calculated by weight, are made from 100-200 parts of kudzu root, 100-200 parts of coix seed, 100-200 parts of poria cocos, 100-300 parts of mulberry, 50-150 parts of yam, 100-200 parts of lotus seed, 20-60 parts of roasted astragalus root, 25-75 parts of dried tangerine peel, and 100-300 parts of quinoa.

2. The weight-loss traditional Chinese medicine preparation as described in claim 1, characterized in that: Its medicinal active ingredients, calculated by weight, are made from 120-180 parts of kudzu root, 120-180 parts of coix seed, 120-180 parts of poria cocos, 150-250 parts of mulberry, 80-120 parts of yam, 120-180 parts of lotus seed, 30-50 parts of roasted astragalus root, 40-60 parts of dried tangerine peel, and 150-250 parts of quinoa.

3. The traditional Chinese medicine preparation for weight loss as described in claim 1 or 2, characterized in that: Its medicinal active ingredients, calculated by weight, are made from 150 parts of kudzu root, 150 parts of coix seed, 150 parts of poria cocos, 200 parts of mulberry, 100 parts of yam, 150 parts of lotus seed, 40 parts of roasted astragalus root, 50 parts of dried tangerine peel, and 200 parts of quinoa.

4. A method for preparing a weight-loss traditional Chinese medicine preparation as described in any one of claims 1-3, characterized in that: Take the medicines from the prescription, combine them with acceptable excipients, and process them according to conventional methods to produce the corresponding pharmaceutical preparations.

5. The preparation method according to claim 4, characterized in that: The pharmaceutical preparation is a decoction, a paste, a hard capsule, a tablet, or a granule.

6. The preparation method as described in claim 5, characterized in that: The method for preparing the decoction is as follows: Weigh all the medicinal materials in the formula according to the proportion, add 10 times the amount of water to soak for 0.5 hours, then decoct for 1 hour after boiling, filter, add 8 times the amount of water to the dregs, boil for 1 hour and take the decoction, mix the two decoctions, filter, and then concentrate to 45-55% of the original liquid, and package to obtain the decoction.

7. The preparation method according to claim 5, characterized in that: The preparation method of the decoction is as follows: Weigh each medicinal material according to the prescription ratio, soak in 8 times the amount of water for 0.5 hours, then decoct for 1.5 hours after boiling, filter, add 6 times the amount of water to the dregs, boil for 1.5 hours and take the decoction, mix the two decoctions, filter, and then concentrate until the relative density at 70℃ is 1.10-1.

20. Take 30-35% of the weight of the above extract of refined honey, slowly add it to the above extract, stir evenly, continue to heat over low heat to thicken the paste, and when a small amount can be drawn into a thread or dripped onto paper without water marks, seal it in a sterile bottle.

8. The preparation method according to claim 5, characterized in that: The preparation method of the hard capsule is as follows: Weigh each medicinal material according to the prescription ratio, soak in 8 times the amount of water for 0.5 hours, decoct, boil for 2 hours, filter, add 6 times the amount of water to the residue, boil for 1 hour, take the decoction, mix the two decoctions, filter, concentrate the filtrate to an extract with a relative density of 1.10-1.20 at 70℃, dry at 70℃ to a dry extract, pulverize into a fine powder, add 10% starch of the prepared amount and mix evenly, granulate with 10% starch slurry, dry, granulate, fill into capsules, and the product is obtained.

9. The preparation method according to claim 5, characterized in that: The preparation method of the tablets is as follows: Weigh each medicinal material according to the prescription ratio, soak in 10 times the amount of water for 0.5 hours, then decoct for 1 hour after boiling, filter, add 6 times the amount of water to the residue, boil for 0.5 hours, collect the decoction, mix the two decoctions, filter, concentrate after filtration, concentrate the filtrate to an extract with a relative density of 1.10-1.20 at 70℃, dry the extract at 70℃ and pulverize it into a fine powder to obtain a dry extract, take the dry extract, mix with 5% starch and 5% talc, granulate with 75% ethanol as a wetting agent, dry, compress into tablets, and film-coat to obtain the final product.

10. The preparation method according to claim 5, characterized in that: The preparation method of the granules is as follows: Weigh each medicinal material according to the prescription ratio, soak in 10 times the amount of water for 0.5 hours, then decoct for 1 hour after boiling, filter, add 8 times the amount of water to the dregs, boil for 0.5 hours, collect the decoction, mix the two decoctions, filter, concentrate after filtration, concentrate the filtrate to an extract with a relative density of 1.10-1.20 at 70℃, dry the extract at 70℃ and pulverize it into fine powder to obtain dry extract, take 1 part of dry extract and 1 part of dextrin, use 75% ethanol as a wetting agent to make granules, dry the granules at 70℃, pass through a 12-mesh sieve once, and separate the fine powder with an 80-mesh sieve to obtain the final product.

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