A traditional Chinese medicine composition for treating diabetes, a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating diabetes, a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials: the husked barley powder, rice bran and millet bran as component A, radix trichosanthis, semen cuscutae, radix ophiopogonis and radix rehmanniae as component B, and radix astragali, herba pterocephali and pericarpium citri reticulatae as component C. The components A, B and C are matched to prepare the traditional Chinese medicine composition which has the effects of invigorating the spleen and nourishing the stomach, benefiting qi and nourishing yin, clearing heat and generating saliva, and tonifying the kidney and eliminating accumulation. The traditional Chinese medicine composition can be used for treating diabetes. The husked barley powder, rice bran and millet bran are innovatively introduced into the traditional Chinese medicine composition, the grain husks of which contain vitamin B which can be involved in the metabolism of sugar and fat, and can not only help to stabilize postprandial blood sugar and improve insulin sensitivity, but also provide satiety, and has the functions of diet therapy meal replacement and nutrition balance.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating diabetes mellitus, its preparation method, and its application. Background Technology

[0002] Diabetes mellitus is a metabolic disease characterized by persistently high blood sugar levels. Its incidence is steadily increasing, and the age of onset is trending younger. Modern medicine believes its cause is insufficient pancreatic secretion or reduced pancreatic activity, leading to impaired blood sugar regulation. Current treatments for diabetes include dietary control, slowing carbohydrate absorption, and injecting exogenous insulin. While these methods can control blood sugar levels to some extent, they primarily focus on symptomatic management and do not fundamentally improve the patient's overall health or restore the body's self-regulating functions.

[0003] In traditional Chinese medicine, diabetes falls under the category of "Xiao Ke Zheng" (wasting and thirsting syndrome). Ancient physicians categorized it into three stages based on symptoms and disease progression: Upper Xiao (lung Xiao), Middle Xiao (spleen Xiao), and Lower Xiao (kidney Xiao), corresponding to the "three highs and one low" symptoms of polyphagia, polydipsia, polyuria, and weight loss as summarized in modern medicine. For the more prevalent type II diabetes, improving insulin secretion and activity is the core of treatment. Insulin needs to bind to insulin receptors to regulate blood sugar, and insulin receptors are closely related to liver function. Clinical studies have confirmed that insulin resistance is one of the most important and fundamental causes inducing and promoting the development of diabetes and hyperlipidemia. According to traditional Chinese medicine theory, wood controls earth; the liver and gallbladder belong to wood, while the spleen and stomach belong to earth. The spleen governs transportation and transformation, and also governs the limbs. Traditional Chinese medicine believes that the occurrence of diabetes is closely related to the dysfunction of multiple organs, including the liver, spleen, and kidneys. Therefore, diabetes is not caused by a single organ dysfunction, but rather by the dysfunction of multiple organs, including the liver, spleen, and kidneys; this imbalance between organ functions is one of its core pathogenesis.

[0004] Based on the above understanding of the pathogenesis, Traditional Chinese Medicine (TCM) treatment of diabetes mellitus focuses on soothing the liver and relieving stagnation, strengthening the spleen and replenishing qi, and nourishing yin and generating fluids. This is achieved through a comprehensive approach including medication, meridian intervention, and dietary therapy, ultimately aiming to improve the patient's constitution and restore normal physiological functions. Polydipsia and polyuria are typical symptoms of diabetes mellitus, essentially stemming from the body's inability to properly retain body fluids, leading to a relative increase in blood sugar. Therefore, nourishing yin and generating fluids to replenish the body's water and restore fluid balance is a key aspect of TCM treatment for diabetes. Combining TCM yin-nourishing methods with dietary therapy can effectively optimize the body's internal environment, alleviate polydipsia and polyuria, restore body fluids to a reasonable homeostasis, thereby reducing the concentration of dissolved blood sugar in the body, promoting the normal transport of nutrients and the excretion of metabolic waste, and ensuring the recovery of bodily functions.

[0005] Therefore, it is particularly necessary to develop a traditional Chinese medicine composition that is both food and medicine for treating diabetes, and to achieve effective treatment of diabetes by nourishing yin and promoting body fluid production. Summary of the Invention

[0006] In view of the above-mentioned prior art, the purpose of this invention is to provide a traditional Chinese medicine composition for treating diabetes mellitus, its preparation method and application.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating diabetes mellitus, comprising component A, component B and component C in a mass ratio of (230-250):(80-120):(260-265); Component A consists of the following raw materials in parts by weight: lotus root powder 25-35 parts, kudzu root 25-35 parts, poria cocos 25-35 parts, water chestnut 25-35 parts, fox nut 25-35 parts, barley with skin 25-35 parts, rice bran 25-35 parts, and millet bran 25-35 parts. Component B consists of the following raw materials in parts by weight: 10-20 parts of Trichosanthes kirilowii root, 5-15 parts of Cuscuta chinensis seed, 5-15 parts of Ophiopogon japonicus root, 10-20 parts of Rehmannia glutinosa root, 10-20 parts of Paeonia suffruticosa root bark, 5-15 parts of Mantis egg case, 5-15 parts of oyster shell powder, 5-15 parts of chicken gizzard lining, and 4-6 parts of ginseng. Component C is composed of the following raw materials in parts by weight: 10-20 parts of Eupatorium fortunei, 10-20 parts of Astragalus membranaceus (processed), 10-20 parts of Glycyrrhiza uralensis (processed), 10-20 parts of Codonopsis pilosula, 10-15 parts of silkworm cocoon, 5-15 parts of Euphorbia humifusa, 10-15 parts of Lophatherum gracile, 10-20 parts of Prunus mume, 5-15 parts of Birch polypore, 10-15 parts of Citrus reticulata peel, 10-20 parts of Phragmites communis rhizome, 10-20 parts of Anemarrhena asphodeloides, 10-15 parts of Sophora flavescens, 10-15 parts of Cistanche deserticola, 10-15 parts of Morus alba leaf, 10-15 parts of Curcuma longa, 10-15 parts of Artemisia capillaris, 10-15 parts of Bupleurum chinense, 10-15 parts of Crataegus pinnatifida (processed), 10-15 parts of Hordeum vulgare (processed), and 5-7 parts of Massa fermentata (processed).

[0008] Preferably, the traditional Chinese medicine composition for treating diabetes mellitus also includes excipients.

[0009] Furthermore, the auxiliary materials include refined honey and perilla seed oil in a mass ratio of 1:(2-4).

[0010] Preferably, the dosage form of the traditional Chinese medicine composition for treating diabetes is pills, ointments, or powders.

[0011] Furthermore, the dosage form of the traditional Chinese medicine composition for treating diabetes is pills.

[0012] A second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating diabetes mellitus, comprising the following steps: (1) Weigh the raw materials of component C according to the weight parts and mix them. After boiling them twice with water, combine the decoctions. Then, concentrate the decoctions under vacuum at low temperature to obtain the extract. (2) Weigh the raw materials of component A and component B according to the weight, mix them and then crush them to obtain a mixture; add excipients to the extract and mix them, then add the mixture and dry it to obtain a traditional Chinese medicine composition for treating diabetes.

[0013] As a preferred option, the specific steps for adding water and decocting twice in step (1) are as follows: add 8-12 times the amount of water to the mixed component C raw material, soak for 25-35 minutes, simmer for 0.5-1.5 hours, filter after decocting, and separate the decoction and the residue; add 6-10 times the amount of water to the residue, simmer for 30-50 minutes, filter and collect the decoction.

[0014] As a preferred option, in step (1), the vacuum low-temperature concentration conditions are: temperature of 60-70℃ and vacuum degree of -80~-90KPa.

[0015] Preferably, in step (1), the relative density of the extract at 60°C is 1.10-1.15.

[0016] Preferably, in step (2), the excipients account for 10-15% of the mass of the traditional Chinese medicine composition for treating diabetes mellitus.

[0017] Preferably, in step (2), the drying temperature is 60-70℃ and the drying time is 10-15h.

[0018] A third aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a pharmaceutical product for treating diabetes mellitus.

[0019] Beneficial effects: 1. This invention uses raw materials such as barley with husks, rice bran, and millet bran to form component A; raw materials such as trichosanthes root and dodder seed to form component B; and raw materials such as agastache rugosa, bamboo shavings, roasted astragalus root, birch polypore, and silkworm cocoons to form component C. Components A, B, and C are combined to obtain a traditional Chinese medicine composition for treating diabetes mellitus. This invention, through the synergistic pharmacological effects of multiple components and pathways, forms a traditional Chinese medicine composition with the functions of strengthening the spleen and stomach, replenishing qi and nourishing yin, clearing heat and promoting body fluid production, and strengthening the kidneys and eliminating stagnation.

[0020] Component A provides a feeling of fullness while delivering stable energy, achieving precise nutritional supplementation and metabolic regulation, thus fundamentally improving glucose and lipid metabolism disorders and insulin resistance. Component B targets the pathogenesis of yin deficiency and dryness-heat, and kidney dysfunction, achieving both symptomatic and root-cause treatment through nourishing yin and generating fluids, tonifying yin and consolidating the kidneys, and stabilizing the underlying condition. Component C is mainly used to regulate the body's qi and blood circulation, clearing damp-heat, stagnation, and blood stasis, improving constitution through soothing the liver and regulating qi, nourishing yin and consolidating the kidneys. The combined use of components A, B, and C achieves a comprehensive treatment system that addresses both symptoms and pathogenesis, and from local to systemic approaches.

[0021] 2. This invention utilizes rice bran, millet bran, and barley with husks as raw materials. These materials are rich in dietary fiber, B vitamins, and γ-aminobutyric acid (GABA), which not only slow down glucose absorption to stabilize postprandial blood sugar but also improve insulin resistance and regulate lipid metabolism, providing a more favorable physiological basis for the functions of components B and C. Furthermore, these components, as both food and medicine, also provide a feeling of fullness, achieving the dual goals of dietary therapy as a meal replacement and nutritional fortification.

[0022] This invention innovatively introduces barley flour with husk, rice bran, and millet bran into a traditional Chinese medicine composition. These grain husks contain B vitamins, which can participate in the metabolism of carbohydrates and fats. They not only help stabilize postprandial blood sugar and improve insulin sensitivity, but also provide a feeling of fullness in a low-calorie manner, thus combining the functions of dietary therapy, meal replacement, and nutritional balance. Detailed Implementation

[0023] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0024] In existing technologies, diabetes falls under the category of "Xiao Ke Zheng" (wasting and thirsting syndrome) in Traditional Chinese Medicine (TCM), characterized by polyphagia, polydipsia, polyuria, and weight loss. Currently, Western medicines such as metformin are commonly used to treat diabetes. Metformin primarily lowers blood sugar by inhibiting hepatic gluconeogenesis and increasing peripheral tissue sensitivity to insulin. Its effect focuses on lowering blood sugar, with a single target, failing to reverse the core pathological process of the disease and lacking holistic regulatory functions. Therefore, this invention provides a TCM composition for treating Xiao Ke Zheng, comprising component A, component B, and component C. Component A consists of lotus root powder, kudzu root, poria cocos, water chestnut, fox nut, barley with husk, rice bran, and millet bran. These components can strengthen the spleen and stomach, relieve irritability and thirst, and eliminate food stagnation, laying the foundation for the subsequent effects of components B and C. Furthermore, in recent years, with the significant improvement in grain processing technology and efficiency, the proportion of deeply processed foods in human food intake has been increasing, leading to nutritional imbalances and component loss, which is one of the reasons for the high incidence of diabetes. Component A, using barley with husk, rice bran, and millet bran, actively supplements dietary fiber and B vitamins, helping to slow down glucose absorption, improve insulin resistance, and regulate lipid metabolism.

[0025] Sun Simiao discovered that people who frequently eat refined white rice are prone to beriberi, lower limb edema, numbness, weakness, and palpitations. He explicitly advised against prolonged consumption of white rice and recommended instead the consumption of coarse rice with bran. The "Prescriptions Worth a Thousand Gold Pieces" also mentions in its section on grain therapy that brown rice and white sorghum porridge nourish the stomach, promote fluid production, and relieve thirst. Meanwhile, modern medicine has proven that B vitamins participate in carbohydrate and fat metabolism and cannot be synthesized by the human body; they must be obtained from external sources. The outer husk and germ of grains are rich in B vitamins. Mechanical processing of refined rice leads to the loss of B vitamins in grains, which is a contributing factor to the high incidence of diabetes in modern times. Using brown rice to improve constitution and regulate the body embodies the wisdom of ancient Chinese medicine and health preservation culture. Based on this, this invention innovatively uses millet bran, rice bran, and barley flour with bran in the treatment of diabetes.

[0026] Component B consists of Trichosanthes kirilowii, Cuscuta chinensis, Ophiopogon japonicus, Rehmannia glutinosa, Paeonia suffruticosa, Mantis egg case, oyster shell powder, chicken gizzard lining, and ginseng. These components nourish yin and generate fluids, tonify the kidneys and astringe, stabilizing the root of the disease. Component C includes Eupatorium fortunei, Astragalus membranaceus (processed), Glycyrrhiza uralensis (processed), Codonopsis pilosula, Bombyx mori cocoon, Euphorbia humifusa, Lophatherum gracile, Prunus mume, Birch polypore, Citrus reticulata peel, Phragmites communis rhizome, Anemarrhena asphodeloides, Sophora flavescens, Cistanche deserticola, Morus alba leaf, Curcuma longa, Artemisia capillaris, Bupleurum chinense, Crataegus pinnatifida (processed), and Massa fermentata (processed). These components have the effects of clearing heat and purging fire, soothing the liver and regulating qi, invigorating qi and promoting blood circulation, and promoting digestion and eliminating stagnation. They can clear pathological products, improve the internal environment, and unblock the body's qi and blood vessels, clearing obstacles for components A and B to exert their effects.

[0027] Formulas C and B draw upon the medical theories, discussions, and classic prescriptions of renowned ancient Chinese physicians regarding diabetes, with the primary aim of comprehensively regulating and improving the patient's constitution. Among them, the "Three Charred Delicacies" (charred hawthorn, charred malt, and charred Shenqu) is a famous formula for relieving indigestion. Formulas C and B were reviewed by a team of experts, including Professor Yang, a doctoral supervisor at Hubei University of Traditional Chinese Medicine, and were finalized after modifications based on their years of clinical experience. Formulas C and B, administered as decoctions, have been used by many patients and have achieved satisfactory results. Adjustments were made based on individual constitution and specific circumstances, according to traditional Chinese medicine principles. One dose daily for half a month resulted in significant improvement in symptoms such as excessive thirst, urination, and irritability; foamy urine decreased; the dosage of Western medicine for blood sugar control was reduced; and other lifestyle habits remained unchanged, achieving ideal blood sugar control. Patients also developed greater confidence in their lives.

[0028] The combination of components A, B, and C constitutes a traditional Chinese medicine composition that is both medicinal and edible, treats both the symptoms and the root cause, and regulates the system.

[0029] Unlike the use of metformin and other Western medicines which mainly focus on lowering blood sugar, this invention, through the synergistic effect of multiple components and multiple targets, can simultaneously improve blood glucose levels, insulin resistance, lipid metabolism, and liver function in diabetic patients, providing a new approach for the clinical treatment of diabetes.

[0030] To enable those skilled in the art to better understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below with reference to specific embodiments.

[0031] In this invention, rice bran and millet bran are a category of rice bran and millet bran, which are by-products produced during the processing of rice and millet into polished rice. They are the husks containing germ and oily components obtained from the last hulling of rice and millet.

[0032] Example 1: A traditional Chinese medicine composition for treating diabetes mellitus 1. Components The traditional Chinese medicine composition for treating diabetes in this embodiment is made from component A, component B and component C in a mass ratio of 240:100:263; Component A consists of the following ingredients in parts by weight: 30 parts lotus root powder, 30 parts kudzu root, 30 parts poria cocos, 30 parts water chestnut, 30 parts fox nut, 30 parts barley with skin, 30 parts rice bran, and 30 parts millet bran. Component B consists of the following raw materials in parts by weight: 15 parts of Trichosanthes kirilowii root, 10 parts of Cuscuta chinensis seed, 10 parts of Ophiopogon japonicus root, 15 parts of Rehmannia glutinosa root, 15 parts of Paeonia suffruticosa root bark, 10 parts of Mantis egg case, 10 parts of oyster shell powder, 10 parts of chicken gizzard lining, and 5 parts of ginseng. Component C is composed of the following raw materials in parts by weight: 15 parts of Eupatorium fortunei, 15 parts of Astragalus membranaceus (processed), 15 parts of Glycyrrhiza uralensis (processed), 15 parts of Codonopsis pilosula, 12 parts of silkworm cocoon, 10 parts of Euphorbia humifusa, 12 parts of Lophatherum gracile, 15 parts of Prunus mume, 10 parts of Birch polypore, 12 parts of Citrus reticulata peel, 15 parts of Phragmites communis rhizome, 15 parts of Anemarrhena asphodeloides, 12 parts of Sophora flavescens, 12 parts of Cistanche deserticola, 12 parts of Morus alba leaf, 12 parts of Curcuma longa, 12 parts of Artemisia capillaris, 12 parts of Bupleurum chinense, 12 parts of Crataegus pinnatifida (processed), 12 parts of Hordeum vulgare (processed), and 6 parts of Massa fermentata (processed).

[0033] 2. Preparation method (1) Weigh and mix all the raw materials of component C, add 10 times the weight of water and soak for 30 minutes, then simmer for 1 hour. After simmering, filter and separate the residue and decoction. Add 8 times the weight of water to the residue and simmer for 40 minutes. After filtration, collect the decoction and combine the two decoctions. Then place the decoction under vacuum at -85KPa and 65℃ to concentrate it at low temperature, and obtain an extract with a relative density of 1.12 at 60℃. (2) Weigh each of the raw materials of component A and component B, mix them evenly and then crush them to obtain a mixture; mix honey and perilla seed oil in a mass ratio of 1:3 and use them as excipients. Add the excipients to the extract and stir evenly, then add the mixture and dry it at 65°C for 12 hours to obtain a traditional Chinese medicine composition for treating diabetes mellitus, wherein the excipients account for 12% of the mass of the traditional Chinese medicine composition for treating diabetes mellitus.

[0034] Example 2: A traditional Chinese medicine composition for treating diabetes mellitus 1. Components The traditional Chinese medicine composition for treating diabetes in this embodiment is made from component A, component B and component C in a mass ratio of 230:80:260; Component A consists of the following raw materials in parts by weight: 25 parts lotus root powder, 25 parts kudzu root, 25 parts poria cocos, 25 parts water chestnut, 25 parts fox nut, 25 parts barley with skin, 25 parts rice bran, and 25 parts millet bran. Component B consists of the following raw materials in parts by weight: 10 parts of Trichosanthes kirilowii root, 5 parts of Cuscuta chinensis seed, 5 parts of Ophiopogon japonicus root, 10 parts of Rehmannia glutinosa root, 10 parts of Paeonia suffruticosa root bark, 5 parts of Mantis egg case, 5 parts of oyster shell powder, 5 parts of chicken gizzard lining, and 4 parts of ginseng. Component C is composed of the following raw materials in parts by weight: 10 parts of Eupatorium fortunei, 10 parts of Astragalus membranaceus (processed), 10 parts of Glycyrrhiza uralensis (processed), 10 parts of Codonopsis pilosula, 10 parts of silkworm cocoon, 5 parts of Euphorbia humifusa, 10 parts of Lophatherum gracile, 10 parts of Prunus mume, 5 parts of Birch polypore, 10 parts of Citrus reticulata peel, 10 parts of Phragmites communis rhizome, 10 parts of Anemarrhena asphodeloides, 10 parts of Sophora flavescens, 10 parts of Cistanche deserticola, 10 parts of Morus alba leaf, 10 parts of Curcuma longa, 10 parts of Artemisia capillaris, 10 parts of Bupleurum chinense, 10 parts of Crataegus pinnatifida (processed), 10 parts of Hordeum vulgare (processed), and 5 parts of Massa fermentata (processed).

[0035] 2. Preparation method (1) Weigh and mix all the raw materials of component C, add 8 times the weight of water and soak for 25 min, then simmer for 0.5 h, filter after simmering, separate the residue and decoction, add 6 times the weight of water to the residue, simmer for 30 min, filter and collect the decoction, combine the two decoctions; then place the decoction at -80 kPa and 60 ℃ for vacuum low temperature concentration to obtain an extract with a relative density of 1.10 at 60 ℃; (2) Weigh each raw material of component A and component B, mix them evenly and then crush them to obtain a mixture; mix honey and perilla seed oil in a mass ratio of 1:2 and use them as excipients. Add the excipients to the extract and stir evenly, then add the mixture and dry it at 60°C for 10 hours to obtain a traditional Chinese medicine composition for treating diabetes mellitus, wherein the excipients account for 10% of the mass of the traditional Chinese medicine composition for treating diabetes mellitus.

[0036] Example 3: A traditional Chinese medicine composition for treating diabetes mellitus 1. Components The traditional Chinese medicine composition for treating diabetes in this embodiment is made from component A, component B and component C in a mass ratio of 250:120:265; Component A consists of the following raw materials in parts by weight: 35 parts lotus root powder, 35 parts kudzu root, 35 parts poria cocos, 35 parts water chestnut, 35 parts fox nut, 35 parts barley with skin, 35 parts rice bran, and 35 parts millet bran. Component B consists of the following raw materials in parts by weight: 20 parts of Trichosanthes kirilowii root, 15 parts of Cuscuta chinensis seed, 15 parts of Ophiopogon japonicus root, 20 parts of Rehmannia glutinosa root, 20 parts of Paeonia suffruticosa root bark, 15 parts of Mantis egg case, 15 parts of oyster shell powder, 15 parts of chicken gizzard lining, and 6 parts of ginseng. Component C is composed of the following raw materials in parts by weight: 20 parts of Eupatorium fortunei, 20 parts of Astragalus membranaceus (processed), 20 parts of Glycyrrhiza uralensis (processed), 20 parts of Codonopsis pilosula, 15 parts of silkworm cocoon, 15 parts of Euphorbia humifusa, 15 parts of Lophatherum gracile, 20 parts of Prunus mume, 15 parts of Birch polypore, 15 parts of Citrus reticulata peel, 20 parts of Phragmites communis rhizome, 20 parts of Anemarrhena asphodeloides, 15 parts of Sophora flavescens, 15 parts of Cistanche deserticola, 15 parts of Morus alba leaf, 15 parts of Curcuma longa, 15 parts of Artemisia capillaris, 15 parts of Bupleurum chinense, 15 parts of Crataegus pinnatifida (processed), 15 parts of Hordeum vulgare (processed), and 7 parts of Massa fermentata (processed).

[0037] 2. Preparation method (1) Weigh and mix all the raw materials of component C, add 12 times the weight of water and soak for 35 min, then simmer for 1.5 h, filter after simmering, separate the residue and decoction, add 10 times the weight of water to the residue, simmer for 50 min, filter and collect the decoction, combine the two decoctions; then place the decoction under vacuum at -90 kPa and 70 ℃ to concentrate at low temperature, and obtain an extract with a relative density of 1.15 at 60 ℃; (2) Weigh each of the raw materials of component A and component B, mix them evenly and then crush them to obtain a mixture; mix honey and perilla seed oil in a mass ratio of 1:4 and use them as excipients. Add the excipients to the extract and stir evenly, then add the mixture and dry it at 70°C for 15 hours to obtain a traditional Chinese medicine composition for treating diabetes mellitus, wherein the excipients account for 15% of the mass of the traditional Chinese medicine composition for treating diabetes mellitus.

[0038] Experimental example: The traditional Chinese medicine composition of this application underwent formulation grouping and phased verification. Due to current limitations imposed by relevant policies, implementation conditions, and the level of informed consent among participants, pills prepared according to the pill preparation process of this invention have not yet been used for application verification. This experimental phase utilizes a combination of traditional Chinese medicine decoctions and dietary therapy for observation. Details are as follows: (1) As mentioned above, Formula C and Formula B draw on the medical theories, discussions and classic prescriptions of famous doctors in ancient China on diabetes, and have been reviewed and modified by the expert team, with the primary purpose of comprehensively regulating and improving the patient's constitution.

[0039] In this experiment, formulations B and C were administered via conventional decoction. The subsequent preparation of pills or ointments will follow established techniques for making pills with honey and low-temperature ointments in traditional Chinese medicine. This phase of the experiment primarily examines the efficacy of the formulations themselves and their combination with dietary therapy. During application, components B and C were prepared according to the proportions described in Example 1 and administered via decoction, one dose daily for 15 consecutive days. Adjustments were made based on individual patient constitution and symptoms under the guidance of a professional TCM practitioner.

[0040] (2) Based on the above-mentioned application of traditional Chinese medicine decoction, the participants should further combine the following dietary therapy methods.

[0041] Choose one or more of lotus root powder, kudzu root powder, and water chestnut powder, and mix them with boiling water to form a paste before consuming. All of these ingredients are edible or have medicinal properties, and can be incorporated into a daily diet to replace some high-starch and high-sugar foods. Simultaneously, millet bran and rice bran can be added to corn flour, mixed, and made into steamed buns, which can be part or all of the staple food for lunch. Using whole barley flour containing wheat bran as the main ingredient, add fox nut powder and a small amount of rolled oats, and cook into porridge, which can be a staple food for dinner or replace some of the regular refined rice and flour staples. The purpose of adopting the above dietary methods is to increase the intake of dietary fiber and whole grains, and appropriately reduce the intake of refined starchy foods.

[0042] The study selected participants with a history of long-term hyperglycemia or long-term use of hypoglycemic drugs for observation. A total of 6 participants with relatively complete usage records were obtained, and their details are shown in Table 1.

[0043] Table 1 Basic Information of Participants The names and contact information of the aforementioned testers are retained as original application records and will not be disclosed in this manual.

[0044] Participants first took the decoctions corresponding to components B and C separately, and their symptoms of increased water intake, thirst, and other signs of excessive thirst were observed; the presence of foam in urine was noted; and their daily blood sugar control was assessed. After 15 days of continuous use, the participants experienced significant improvement in symptoms of excessive thirst and urination, and a marked reduction in foamy urine. With other lifestyle habits remaining unchanged, the desired blood sugar control effect was achieved.

[0045] Further combining the herbal decoction treatment with a dietary therapy plan, the participants' blood sugar levels were able to be maintained within their predetermined control targets. Based on this, some participants, under professional guidance, reduced their original dosage of hypoglycemic drugs. Specifically, some participants recorded a reduction of approximately one-third in their hypoglycemic drug dosage compared to before treatment, and a few recorded a reduction of approximately one-half, while their daily self-monitored blood sugar levels remained within their predetermined control targets.

[0046] Among the participants who did not use Western medicine to lower blood sugar, those who regularly ate whole barley flour or barley porridge with the skin on as their main dinner food, and intermittently consumed kudzu root powder, lotus root powder, or water chestnut powder, generally maintained relatively stable daily blood sugar self-test results.

[0047] In conclusion, when Formulas B and C are used in decoction form and combined with a dietary therapy based on rice bran, they have a certain positive effect on improving the accompanying symptoms such as thirst and polyuria in patients with abnormal blood sugar, as well as maintaining stable blood sugar levels.

[0048] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A traditional Chinese medicine composition for treating diabetes mellitus, characterized in that, The traditional Chinese medicine composition comprises component A, component B, and component C in a mass ratio of (230-250):(80-120):(260-265); Component A consists of the following raw materials in parts by weight: lotus root powder 25-35 parts, kudzu root 25-35 parts, poria cocos 25-35 parts, water chestnut 25-35 parts, fox nut 25-35 parts, barley with skin 25-35 parts, rice bran 25-35 parts, and millet bran 25-35 parts. Component B consists of the following raw materials in parts by weight: 10-20 parts of Trichosanthes kirilowii root, 5-15 parts of Cuscuta chinensis seed, 5-15 parts of Ophiopogon japonicus root, 10-20 parts of Rehmannia glutinosa root, 10-20 parts of Paeonia suffruticosa root bark, 5-15 parts of Mantis egg case, 5-15 parts of oyster shell powder, 5-15 parts of chicken gizzard lining, and 4-6 parts of ginseng. Component C is composed of the following raw materials in parts by weight: 10-20 parts of Eupatorium fortunei, 10-20 parts of Astragalus membranaceus (processed), 10-20 parts of Glycyrrhiza uralensis (processed), 10-20 parts of Codonopsis pilosula, 10-15 parts of silkworm cocoon, 5-15 parts of Euphorbia humifusa, 10-15 parts of Lophatherum gracile, 10-20 parts of Prunus mume, 5-15 parts of Birch polypore, 10-15 parts of Citrus reticulata peel, 10-20 parts of Phragmites communis rhizome, 10-20 parts of Anemarrhena asphodeloides, 10-15 parts of Sophora flavescens, 10-15 parts of Cistanche deserticola, 10-15 parts of Morus alba leaf, 10-15 parts of Curcuma longa, 10-15 parts of Artemisia capillaris, 10-15 parts of Bupleurum chinense, 10-15 parts of Crataegus pinnatifida (processed), 10-15 parts of Hordeum vulgare (processed), and 5-7 parts of Massa fermentata (processed).

2. The traditional Chinese medicine composition for treating diabetes mellitus as described in claim 1, characterized in that, The traditional Chinese medicine composition for treating diabetes also includes excipients; the excipients include refined honey and perilla seed oil, with a mass ratio of 1:(2-4).

3. The traditional Chinese medicine composition for treating diabetes mellitus as described in claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition for treating diabetes is pills, ointments, or powders.

4. A method for preparing the traditional Chinese medicine composition for treating diabetes mellitus according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Weigh the raw materials of component C according to the weight parts and mix them. After boiling them twice with water, combine the decoctions. Then, concentrate the decoctions under vacuum at low temperature to obtain the extract. (2) Weigh the raw materials of component A and component B according to the weight, mix them and then crush them to obtain a mixture; add excipients to the extract and mix them, then add the mixture and dry it to obtain a traditional Chinese medicine composition for treating diabetes.

5. The method for preparing the traditional Chinese medicine composition for treating diabetes mellitus as described in claim 4, characterized in that, In step (1), the specific steps for adding water and decocting twice are as follows: add 8-12 times the amount of water to the mixed component C raw material, soak for 25-35 minutes, simmer for 0.5-1.5 hours, filter after decocting, and separate the decoction and the residue; add 6-10 times the amount of water to the residue, simmer for 30-50 minutes, filter and collect the decoction.

6. The method for preparing the traditional Chinese medicine composition for treating diabetes mellitus as described in claim 4, characterized in that, In step (1), the vacuum low-temperature concentration conditions are: temperature of 60-70℃ and vacuum degree of -80~-90KPa.

7. The method for preparing the traditional Chinese medicine composition for treating diabetes mellitus as described in claim 4, characterized in that, In step (1), the relative density of the extract at 60°C is 1.10-1.

15.

8. The method for preparing the traditional Chinese medicine composition for treating diabetes mellitus as described in claim 4, characterized in that, In step (2), the excipients account for 10-15% of the mass of the traditional Chinese medicine composition for treating diabetes mellitus.

9. The method for preparing the traditional Chinese medicine composition for treating diabetes mellitus as described in claim 4, characterized in that, In step (2), the drying temperature is 60-70℃ and the drying time is 10-15h.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a pharmaceutical product for treating diabetes mellitus.

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