Traditional Chinese medicine composition for treating prediabetes as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for treating prediabetes and a preparation method thereof, and belongs to the field of traditional Chinese medicines. The composition is prepared from the following raw material medicines: 10 to 20 parts of rhizoma coptidis, 20 to 30 parts of radix astragali seu hedysari, 20 to 30 parts of rhizoma dioscoreae, 12 to 30 parts of rhizoma atractylodis, 10 to 20 parts of herba eupatorii, 15 to 30 parts of roasted rhizoma atractylodis macrocephalae, 15 to 20 parts of poria cocos and 10 to 20 parts of radix ophiopogonis. The traditional Chinese medicine composition disclosed by the invention is prepared according to the traditional Chinese medicine theory of replenishing qi to invigorate the spleen, clearing heat and drying dampness, nourishing yin and promoting the secretion of saliva or body fluid, and aims at regulating glycometabolism, improving the pancreas islet function and controlling abnormal blood glucose; the preparation method comprises the steps of crushing, mixing, wet granulation, drying and the like, and the stability and the curative effect consistency of the granules are ensured. The traditional Chinese medicine composition has the advantages of multiple targets, low side effect, high compliance and the like by systematically optimizing the formula and standardizing the preparation process, is suitable for intervention treatment of the early stage of diabetes, and has good clinical value and industrialization prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition for treating prediabetes, a preparation method thereof, and an application thereof. Background Art

[0002] Prediabetes (PDM) refers to a stage in which fasting or post-load blood glucose levels are elevated but have not yet reached the diagnostic criteria for diabetes. This condition, also known as impaired glucose regulation, is often a precursor to diabetes, and impaired glucose regulation indicates an increased risk of developing diabetes, cardiovascular disease, cancer, and neurological disorders. Numerous studies have shown that damage from high blood sugar levels can occur before diabetes is diagnosed. Without intervention, patients with prediabetes are at high risk of developing diabetes, which can lead to serious damage to their overall health.

[0003] As a reversible stage, prediabetes urgently requires timely intervention to prevent it from progressing to diabetes. Existing treatments primarily rely on lifestyle changes, such as diet control, increased exercise, and active weight loss. These interventions have been shown to be the simplest and most effective way to delay the transition from prediabetes to diabetes. Furthermore, early intervention in prediabetes can also help reduce the damage caused by elevated blood sugar levels, thus playing an important role in preventing diabetes and its complications.

[0004] Currently, the main treatments for prediabetes include biguanides, α-glucosidase inhibitors, dipeptidyl peptidase IV (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and berberine hydrochloride. While Western medicine alone has some efficacy in treating prediabetes, these medications are often associated with adverse reactions, such as poor patient compliance, drug tolerance issues, and high drug costs. Therefore, finding a treatment option that is effective for prediabetes while also being safe, low in side effects, and economical is a pressing need in the current treatment of prediabetes.

[0005] Studies have found that lifestyle intervention can effectively assist drug treatment and further delay the transformation of prediabetes to diabetes. Increasing vegetable intake in the diet, reducing alcohol and simple sugar intake, increasing appropriate exercise and losing weight have all been shown to significantly reduce the risk of diabetes. However, relying solely on lifestyle intervention, especially for prediabetic patients who require long-term control, often has limited effect. Therefore, the development of a Chinese medicine composition that can enhance the effect of lifestyle intervention and provide long-term treatment under the premise of safety has important clinical value.

[0006] Currently, several traditional Chinese medicine (TCM) compositions have been used clinically to treat prediabetes. However, most existing treatment options still suffer from limited efficacy, significant side effects, and prolonged treatment. Therefore, there is an urgent need for new TCM compositions that, through optimized formulations and enhanced therapeutic efficacy, can better control prediabetes symptoms with fewer side effects. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a Chinese medicine composition for treating prediabetes, so as to solve the following problems existing in the prior art: traditional Chinese medicine prescriptions for treating prediabetes often have problems such as unreasonable compatibility structure, unclear pharmacological targets, lack of preparation process standardization and insufficient clinical verification, resulting in unstable therapeutic effects, poor drugability, and difficulty in modern promotion and application.

[0008] To overcome the above-mentioned defects of the prior art, the present invention provides a Chinese medicine composition for treating prediabetes, which comprises the following raw materials in parts by weight: 10-20 parts of coptis chinensis, 20-30 parts of astragalus, 20-30 parts of yam, 12-30 parts of atractylodes, 10-20 parts of perilla, 15-30 parts of stir-fried atractylodes, 15-20 parts of poria, and 10-20 parts of ophiopogon.

[0009] Compared with the prior art, the Chinese medicine composition for treating prediabetes of the present invention has the following advantages: the Chinese medicine composition of the present invention fully integrates the traditional Chinese medicine treatment principles of "tonifying Qi and strengthening the spleen, clearing away heat and dampness, nourishing Yin and promoting fluid production" in its formulation design, and targets the common pathogenesis of "spleen deficiency with dampness, and damage to both Qi and Yin" in prediabetes, and exerts a comprehensive effect in terms of overall regulating the functions of internal organs, improving insulin sensitivity, and controlling abnormal blood sugar. Specifically: Astragalus and Chinese yam are both monarch herbs, which have the effects of invigorating qi and strengthening the spleen, tonifying the middle and strengthening the exterior. Modern pharmacological studies have shown that they can enhance insulin sensitivity and delay the progression of impaired glucose tolerance. Coptis chinensis clears away heat and dampness, purges fire and detoxifies, and is a medicine mainly used for the syndrome of "internal accumulation of dampness and heat". The berberine it contains can lower fasting blood sugar and inhibit gluconeogenesis. Atractylodes lancea, stir-fried white atractylodes, and Cyperus rotundus can dry out dampness and invigorate the spleen, and can also clear turbidity through aromatics. They target metabolic disorders caused by spleen deficiency and dampness, improve spleen and stomach function, and inhibit pancreatic β-cell damage. Poria strengthens the spleen and eliminates dampness, calms the mind and soothes the nerves, regulates sugar and lipid metabolism, and enhances the spleen's absorption and distribution of nutrients; Ophiopogon japonicus nourishes yin and moistens the lungs, promotes the production of body fluids and quenches thirst, helps to alleviate the common symptoms of "deficient heat and damage to body fluids" in patients with prediabetes, and maintains endocrine metabolic stability.

[0010] The present invention not only realizes the therapeutic idea of "multi-target, system conditioning" in traditional Chinese medicine prescription, but also combines modern pharmaceutical preparation technology, adopts wet granulation or compression molding process to standardize the preparation of powder, overcomes the defects of traditional decoction cumbersome decoction, uncontrollable quality, etc., improves the consistency, dissolution and patient compliance of the preparation, and compared with the prior art, the present invention structures traditional empirical medication into a traditional Chinese medicine composition with quantitative standards, and solves the key problems such as unstable efficacy, difficult standardization of production, and lack of data support for clinical application in the treatment of prediabetes with traditional Chinese medicine by optimizing dosage form and process. According to the clinical observation implemented by the present invention, in 173 cases of prediabetes patients, the total effective rate reached 65.90%, which verified its significant therapeutic effect in regulating sugar metabolism and improving pancreatic islet function. In summary, the various components in the Chinese medicine composition of the present invention not only have a synergistic effect in pharmacological mechanism, but its scientific ratio and standardized preparation process also constitute an inseparable organic whole in the technical solution, which can fundamentally achieve effective intervention in the chronic metabolic state of prediabetes, and has good industrial feasibility and wide clinical promotion value.

[0011] In one possible embodiment, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of coptis chinensis, 20-25 parts of astragalus, 20-25 parts of yam, 12-20 parts of atractylodes, 10-15 parts of perilla, 15-20 parts of stir-fried atractylodes, 15-18 parts of poria, and 10-15 parts of ophiopogon.

[0012] In a possible embodiment, the Chinese medicine composition includes the following raw materials in parts by weight: 10 parts of Coptis chinensis, 20 parts of Astragalus membranaceus, 20 parts of Chinese yam, 12 parts of Atractylodes lancea, 10 parts of Cyperus rotundus, 15 parts of stir-fried Atractylodes macrocephala, 15 parts of Poria cocos, and 10 parts of Ophiopogon japonicus.

[0013] Compared with the existing technology, the present invention adopts the above technical scheme. On the basis of TCM's "differentiation and treatment", it combines modern pharmacology and metabolic disease characteristics, and through systematic optimization of the synergistic compatibility ratio of eight Chinese medicines, the overall prescription forms a synergistic effect in regulating blood sugar, improving pancreatic function, regulating the spleen and stomach, drying dampness and clearing turbidity, and nourishing yin and invigorating qi. Among them, Coptis chinensis and Atractylodes lancea jointly play the role of drying dampness and clearing heat, targeting the pathological characteristics of "internal accumulation of dampness and heat" in patients with prediabetes; Astragalus membranaceus is matched with Chinese yam and Poria cocos to strengthen qi and invigorate the spleen, and enhance the overall metabolic function; stir-fried Atractylodes macrocephala and Cymbopogon citratus dry dampness and wake up the spleen, and assist in transporting water and dampness; Ophiopogon japonicus moisturizes and nourishes yin, and harmonizes the medicinal properties of various medicines. Through the above-mentioned optimized ratio, not only the synergistic effect between the drugs is enhanced, but also the problem of biased or mutual antagonism of medicinal properties is avoided.

[0014] The technical problem to be solved by the present invention is to provide a method for preparing a traditional Chinese medicine composition for treating prediabetes, so as to solve the problems existing in the prior art such as vague formula ingredients, unclear process parameters, poor stability of preparation particles and insufficient efficacy of traditional Chinese medicine, thereby realizing a traditional Chinese medicine granule preparation with stable efficacy, palatable dosage form and controllable process.

[0015] In order to overcome the above defects of the prior art, the present invention provides a method for preparing the Chinese medicine composition for treating prediabetes, comprising the following steps: S1: Weigh coptis root, astragalus root, yam, atractylodes, euphratica root, stir-fried atractylodes, poria, and ophiopogon respectively to ensure that the quality ratio of each raw material meets the requirements; S2: Grind the raw materials in step S1 into fine powder and screen to a suitable particle size; S3: The raw materials crushed in step S2 are mixed uniformly according to a certain proportion to obtain a mixed powder; S4: mixing the mixed powder obtained in step S3 with an appropriate amount of excipients, adding a solvent, and preparing a drug paste; S5: granulating the drug paste obtained in step S4 through a granulator to prepare a granular preparation; S6: drying the granule preparation obtained in step S5 until the moisture content meets the standard to ensure the stability and storage of the granules; S7: Packing the particles obtained in step S6 to obtain a granular preparation for treating prediabetes.

[0016] Compared with the prior art, the present invention provides a preparation method of a traditional Chinese medicine composition for treating prediabetes, which has the following advantages: the traditional Chinese medicine preparations in the prior art often have the problems of unclear formula ratios and large differences between production batches. The present invention ensures the synergistic and stable release of the active ingredients by clarifying the proportion range of medicinal materials and the proportion control of auxiliary materials, thereby improving the consistency of therapeutic effect from the source. Secondly, compared with the traditional dry pressing process, the present invention significantly improves the granule forming rate, granule fluidity and solubility by adding appropriate amounts of liquid and adhesive to form a uniform medicine paste and then granulating, thereby improving patient compliance. In the formula, coptis root and atractylodes lancea work together to clear away heat and dry dampness, astragalus and yam replenish qi and strengthen the spleen, stir-fried atractylodes and poria regulate the middle and harmonize the stomach, ophiopogon nourishes yin and moisturizes dryness, and cyperus rotundus aromatically transforms dampness. The whole formula is formed by the coordination of monarch, minister, assistant and envoy. The invention forms a multi-level, multi-target and synergistic mechanism, thereby more effectively intervening in the metabolic disorder state of prediabetes. The preparation method of the invention forms an industrial preparation process with controlled whole process and significant efficacy through precise proportion of medicinal materials → optimization of crushing particle size → wet gelatinization granulation → drying and moisture control → packaging of finished whole particles, which complies with the process specifications and regulatory requirements of modern Chinese medicine preparations. In general, the invention effectively solves the problems of unstable efficacy, unformed particles and poor clinical compliance of Chinese medicine preparations existing in the background technology through reasonable optimization and clear definition of medicinal material components, granulation methods, drying conditions and auxiliary materials, and achieves significant improvement in the efficacy, safety, process controllability and industrial adaptability of Chinese medicine composition preparations for treating prediabetes.

[0017] In a possible embodiment, in step S2, the particle size is 80-120 mesh.

[0018] Compared with the existing technology, the adoption of the above-mentioned technical solution, by controlling the particle size between 80-120 meshes, can not only ensure the full mixing of the raw materials, but also facilitate water absorption and wetting into a paste and subsequent uniform granulation, thereby forming granules with dense structure, uniform particle size and good fluidity. The prepared granules are superior to similar Chinese medicine granules in the existing technology in terms of stability, solubility and ease of administration, significantly improving patients' medication compliance and providing process support for the industrialization of modern Chinese medicine preparations.

[0019] In a possible embodiment, in step S4, the auxiliary materials include starch and hydroxypropyl methylcellulose.

[0020] Compared with existing technologies, the above-mentioned technical solution utilizes starch, a traditional excipient in traditional Chinese medicine preparations, with its excellent hygroscopicity and adhesive properties. It acts as a binder and diluent during the granulation process, enabling the powder to form a uniform, moist paste after liquid addition, facilitating the initial formation of granules. However, when starch is used alone, its adhesive strength is limited, which can lead to loose granules and low granulation rates. Hydroxypropyl methylcellulose (HPMC), a semi-synthetic polymer excipient with excellent film-forming and thermal gelling properties, plays a role in stabilizing the structure, increasing hardness, and enhancing disintegration control in granule preparation. It disperses evenly in aqueous solution and forms a network-like framework during the drying process, enhancing the density and mechanical strength of the granules. This invention achieves the stability, effectiveness, and industrial feasibility of the granule preparations of the traditional Chinese medicine composition described herein through the synergistic effects of the rational selection and proportion control of excipients with multiple technical factors, including the granulation process, raw material particle size, and drying parameters.

[0021] In a possible embodiment, in step S5, the granulation is performed by a granulator under the condition of: compression molding or wet granulation to obtain a granular preparation with a particle diameter ranging from 1 to 3 mm.

[0022] Compared with the existing technology, the above technical solution can significantly improve the physical stability of the particles with a particle size of more than 1 mm, reduce the fine powder content, and improve the compressive resistance during packaging and transportation. A particle size of no more than 3 mm ensures a moderate disintegration rate of the particles, which can quickly dissolve and release active ingredients after taking, avoiding delayed efficacy. Secondly, compression molding or wet granulation can be flexibly selected according to production needs and formula characteristics. Compression molding is suitable for formulation systems with low hygroscopicity and good fluidity, while wet granulation is suitable for situations containing more polysaccharides and sticky Chinese medicinal materials, and can better enhance the binding force between drug powders.

[0023] In a possible embodiment, in step S6, the granule preparation is dried under the condition that the moisture content of the granules is ≤1.5%.

[0024] Compared with the existing technology, the above technical solution can significantly improve the physical stability and storage performance of granules, prevent problems such as deterioration, mold or degradation of active ingredients caused by residual moisture, thereby extending the shelf life of the product and ensuring the safety and effectiveness of clinical use.

[0025] The present invention also provides an application of the traditional Chinese medicine composition, which includes the use of the traditional Chinese medicine composition in treating patients with prediabetes. The traditional Chinese medicine composition includes dosage forms such as oral liquid, tablets, capsules, powders, and pills prepared by a drug carrier.

[0026] Compared with the existing technology, the application of the Chinese medicine composition described in the present application has the following advantages: Compared with the existing technology, the application of the Chinese medicine composition described in the present invention has significant advantages in dosage form development, clinical adaptability and therapeutic target coverage: First, in terms of dosage form diversity, the present invention expands the traditional Chinese medicine powder preparation technology to modern pharmaceutical forms, such as oral liquid, tablets, capsules, powders, pills, etc., solving the problems of traditional Chinese medicine "inconvenience in taking, inaccurate dosage, and poor patient compliance". Through the rational design of different dosage forms, the differentiated needs of different patient groups (such as the elderly and children) in terms of swallowing ability, onset speed, and duration of drug effect can be met. Secondly, in terms of technical principles, the traditional Chinese medicine composition of the present invention is based on the principles of "clearing heat and dampness, strengthening the spleen and replenishing qi", supplemented by the effects of nourishing yin and moistening dryness, harmonizing the middle and removing dampness, to comprehensively regulate pancreatic function and improve insulin resistance. At the same time, it systematically intervenes in the TCM syndrome type of "Qi and Yin deficiency with dampness and heat" in prediabetes. Based on scientific compatibility, the composition of the present invention uses modern formulation processes (including wet granulation, tableting, and coating protection) to stably load the active ingredients of the traditional Chinese medicine into different dosage forms, ensuring their bioavailability and targeted and controllable release of the active ingredients. Thirdly, the present invention not only defines the compatibility ratio and preparation process of the traditional Chinese medicine composition, but also, through the analysis of the applicability of different dosage forms, organically integrates drug efficacy, precise dosage control, dosage form stability, and patient compliance, making the composition more clinically applicable in the treatment of prediabetes.

[0027] In summary, the application of the Chinese medicine composition of the present invention in different dosage form carriers not only improves the stability and dosage form diversity of the preparation, but also improves the patient's medication compliance and drug efficacy expression, overcomes the problems of "large fluctuations in drug efficacy, poor individual response, and inconvenience in clinical use" in the existing technology, enhances the applicability, systematicity and conversion value of the composition in the treatment of prediabetes, and has a good industrialization foundation and promotion prospects. DETAILED DESCRIPTION

[0028] First, those skilled in the art should understand that these embodiments are merely used to explain the technical principles of the embodiments of the present application and are not intended to limit the scope of protection of the embodiments of the present application. Those skilled in the art may adjust them as needed to suit specific application scenarios.

[0029] The present invention provides a traditional Chinese medicine composition for treating prediabetes, which comprises the following raw materials by weight: 10-20 parts of coptis chinensis, 20-30 parts of astragalus, 20-30 parts of yam, 12-30 parts of atractylodes, 10-20 parts of perilla, 15-30 parts of stir-fried atractylodes, 15-20 parts of poria, and 10-20 parts of ophiopogon.

[0030] As a preferred solution, the Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of coptis chinensis, 20-25 parts of astragalus, 20-25 parts of yam, 12-20 parts of atractylodes, 10-15 parts of perilla, 15-20 parts of stir-fried atractylodes, 15-18 parts of poria, and 10-15 parts of ophiopogon.

[0031] As a preferred solution, the Chinese medicine composition includes the following raw materials in parts by weight: 10 parts of Coptis chinensis, 20 parts of Astragalus membranaceus, 20 parts of Chinese yam, 12 parts of Atractylodes macrocephala, 10 parts of Cyperus rotundus, 15 parts of stir-fried Atractylodes macrocephala, 15 parts of Poria cocos, and 10 parts of Ophiopogon japonicus.

[0032] The present invention also provides a method for preparing the traditional Chinese medicine composition for treating prediabetes, comprising the following steps: S1: Weigh coptis root, astragalus root, yam, atractylodes, euphratica root, stir-fried atractylodes, poria, and ophiopogon respectively to ensure that the quality ratio of each raw material meets the requirements; S2: Grind the raw materials in step S1 into fine powder and screen to a suitable particle size; S3: The raw materials crushed in step S2 are mixed uniformly according to a certain proportion to obtain a mixed powder; S4: mixing the mixed powder obtained in step S3 with an appropriate amount of excipients, adding a solvent, and preparing a drug paste; S5: granulating the drug paste obtained in step S4 through a granulator to prepare a granular preparation; S6: drying the granule preparation obtained in step S5 until the moisture content meets the standard to ensure the stability and storage of the granules; S7: Packing the particles obtained in step S6 to obtain a granular preparation for treating prediabetes.

[0033] As a preferred solution, in step S2, the particle size is 80-120 mesh.

[0034] As a preferred solution, in step S4, the auxiliary materials include starch and hydroxypropyl methylcellulose.

[0035] As a preferred solution, in step S5, the granulation is performed by a granulator under the following conditions: compression molding or wet granulation is performed to obtain a granular preparation with a particle diameter ranging from 1 to 3 mm.

[0036] As a preferred solution, in step S6, the granule preparation is dried under the condition that the moisture content of the granules is ≤1.5%.

[0037] The present invention also provides an application of the traditional Chinese medicine composition, which includes the use of the traditional Chinese medicine composition in treating patients with prediabetes. The traditional Chinese medicine composition includes dosage forms such as oral liquid, tablets, capsules, powders, and pills prepared by a drug carrier.

[0038] The following provides specific examples in combination with actual data to further expand and illustrate the above-mentioned technical solutions of the present invention: Example 1

[0039] This embodiment provides a traditional Chinese medicine composition for treating prediabetes and a preparation method thereof, wherein the granules are prepared by a wet granulation process, as follows: API ratio (unit: parts by weight) 10 parts of Coptis chinensis, 20 parts of Astragalus root, 20 parts of Chinese yam, 12 parts of Atractylodes lancea, 10 parts of Cyperus rotundus, 15 parts of stir-fried Atractylodes macrocephala, 15 parts of Poria cocos, 10 parts of Radix Ophiopogonis Excipients: Corn starch: 6% of the total mass of mixed powder Hydroxypropyl methylcellulose (HPMC): 2% of the total mass of the mixed powder Preparation steps: S1. Weighing and pretreatment of API Weigh the above-mentioned Chinese medicinal materials separately, check the weight, and place them in a clean and dry place for later use; S2. Crushing and screening All raw materials were crushed into fine powder, screened with a vibrating screen, and the particle size was controlled at 100 mesh to ensure uniform mixing and good particle formation; S3. Dry Mixing Put the screened Chinese medicine powders into a high-speed mixer according to the ratio and mix for 5-10 minutes at a stirring speed of 300 rpm to ensure that the powders are uniform; S4. Excipient premixing and granulation preparation Slowly add an appropriate amount of purified water (accounting for 15% of the mixed powder mass, and control the liquid addition rate to about 20 ml / min) to the mixed powder. Add the excipients starch and HPMC at the same time, and stir at a low speed using a paddle stirrer for 10 minutes until a moist and uniform drug paste is formed. S5. Compression granulation A swing granulator with a pore size of 1.5 mm was used for wet granulation, and the discharge speed was controlled to obtain round drug granules; S6. Drying Spread the wet granules flat on a stainless steel baking tray, place in a hot air circulation drying oven, and dry at 60°C for 3 hours, or until the moisture content is no more than 1.5%, to ensure the granules are stable; S7. Finished product screening and packaging The dried particles are sieved to remove large lumps or powder, and are packed into sealed composite film bags to obtain a traditional Chinese medicine granule preparation for treating prediabetes. Example 2

[0040] This embodiment provides a traditional Chinese medicine composition for treating prediabetes prepared by a low-ratio process, and the granules are prepared by compression molding granulation, as follows: Ratio of raw materials (unit: parts by weight): 10 parts of Coptidis Rhizoma, 20 parts of Astragalus, 20 parts of Chinese Yam, 12 parts of Atractylodes, 10 parts of Cyperus rotundus, 15 parts of stir-fried Atractylodes, 15 parts of Poria, and 10 parts of Radix Ophiopogonis.

[0041] Excipient addition ratio: Corn starch: 5% of the total weight of the mixed powder Hydroxypropyl methylcellulose (HPMC): 1.5% of the total mass of the mixed powder Preparation steps: S1. Weighing and pretreatment of API Weigh the required Chinese medicinal materials according to the above ratio, remove impurities, air-dry them, and ensure they are dry for later use; S2. Crushing and screening Each Chinese medicinal material is crushed using a high-speed grinder and sieved using an 80-mesh screen to ensure fine powder particle size, which is conducive to uniform tableting. S3. Dry Mixing Place the processed powder into a two-dimensional motion mixer and mix for 10 minutes to ensure uniform mixing of the ingredients. Do not add water in this step to maintain the powder dry. S4. Excipient premixing and granulation preparation Add corn starch and HPMC to the mixed powder in proportion and mix again. During this process, the indoor humidity must be controlled below 50% to prevent the powder from absorbing moisture and agglomerating. S5. Compression granulation The mixed powder is directly pressed into strips by a rotary compression granulator at low pressure, and then crushed and sized by a sieve to obtain dry granules with a diameter of about 1 mm. S6. Drying If the obtained particles still contain a certain amount of moisture (>2%), place them in a hot air circulation oven at 40°C and dry them for 1.5 hours to control the final moisture content to ≤1.5% to ensure the stability of the particles; S7. Finished product screening and packaging The dried particles are sieved to remove unqualified particles and excessively fine powder, and are packaged in sealed bags to complete the preparation of the finished product. Example 3

[0042] This example uses high-ratio raw materials to prepare a traditional Chinese medicine composition for treating prediabetes. Combined with a wet granulation process, the granules are formed to a maximum particle size of 3 mm, suitable for oral granule dosage forms: Ratio of raw materials (unit: parts by weight): 20 parts of Coptidis Rhizoma, 30 parts of Astragalus, 30 parts of Chinese Yam, 30 parts of Atractylodes, 20 parts of Cyperus, 30 parts of stir-fried Atractylodes, 20 parts of Poria, and 20 parts of Radix Ophiopogonis.

[0043] Proportion of auxiliary materials added: Corn starch: 8% of the total weight of the mixed powder Hydroxypropyl methylcellulose (HPMC): 2.5% of the total mass of the mixed powder Preparation steps: S1. Weighing and pretreatment of API Take the above-mentioned proportions of each Chinese medicine raw material, remove impurities, dry it in 60°C warm air for 30 minutes to reduce the water content if necessary, and weigh it for later use; S2. Crushing and screening After crushing separately, sieve with 120 mesh screen to make the powder finer, improve mixing uniformity and granulation performance; S3. Dry mixing The powder was mixed in a high-speed mixer for 7 minutes at a stirring speed of 350 rpm to ensure uniform distribution of the ingredients in the formula; S4. Excipient premixing and granulation preparation Slowly add purified water according to 18% of the total weight of the mixed powder, add excipients at the same time, and stir with a low-speed stirrer for 15 minutes to form a thick and uniform wet paste; S5. Compression granulation Use a drum granulator with a 3 mm aperture template to granulate, and control the discharge speed to avoid crushing or squeezing unformed granules; S6. Drying The granules were placed in a stainless steel drying tray, placed in a hot air circulation oven, and dried at 55°C for 4 hours, turning the granules once every hour. The final granule moisture content was controlled at ≤1.5%; S7. Finished product screening and packaging After drying, the grains are sized to remove overly coarse particles and fine powder, resulting in a product with uniform color and full grains. The product is vacuum-packed in aluminum-plastic composite bags and stored in a cool, dry place.

[0044] From 2018 to 2022, the Chinese medicine composition provided by the present invention was used in the clinical treatment of patients with prediabetes in a tertiary medical institution, with a total of 173 cases included. According to the unified efficacy evaluation standard, after systematic treatment, 57 cases were ineffective, 75 cases improved, and 39 cases were clinically cured, with a total effective number of 114 cases, an effective rate of 65.90%, and a cure rate of 22.54%. This prescription has been approved by medical institutions for the preparation of traditional Chinese medicine preparations using traditional techniques for clinical Chinese medicine preparations, and has good application prospects and promotion value.

[0045] The clinical efficacy evaluation criteria are as follows: Clinical recovery: symptom score reduction rate ≥ 90%; Improvement: symptom score reduction rate ≥ 30% and < 90%; Ineffective: The symptom score reduction rate is < 30%.

[0046] The calculation method for the syndrome score reduction rate (using the nimodipine method) is as follows: [(score before treatment - score after treatment) ÷ score before treatment] × 100%.

[0047] The specific test scoring criteria are shown in Table 1: Table 1: Clinical efficacy evaluation criteria

[0048] The specific operations and clinical validation results of the above examples further demonstrate that the Chinese medicine composition for treating prediabetes provided by the present invention and its preparation method have good stability, drugability, and significant therapeutic effects. Based on the traditional Chinese medicine theory of "invigorating Qi and strengthening the spleen, clearing heat and drying dampness, regulating the middle and harmonizing the stomach," the present invention selects eight medicinal herbs: coptis chinensis, astragalus, yam, atractylodes, perilla, stir-fried atractylodes, poria, and ophiopogon. Through modern pharmacological research and prescription composition principles, the compatibility ratio is optimized to form a drug combination with a rigorous structure and complementary functions.

[0049] Among them, Coptis chinensis primarily clears heat and dampness, purging fire and detoxifying, targeting the symptoms of internal heat and dampness commonly found in prediabetic patients. Astragalus and Chinese yam invigorate Qi and strengthen the spleen, strengthening the foundation and nourishing the vital energy. Atractylodes lancea and Cyperus rotundus invigorate the spleen, clearing turbidity and invigorating the spleen, and assisting the spleen and stomach in digestion and transformation. Stir-fried Atractylodes macrocephala and Poria cocos invigorate the spleen, aiding in the transformation of dampness and water retention. Ophiopogon japonicus nourishes Yin, moistens dryness, and moderates the effects of the medicinal properties. The synergistic effects of these herbs in invigorating Qi and Yin, clearing heat and drying dampness, not only comprehensively regulate the "Yin deficiency with dampness and spleen deficiency" underlying the pathogenesis of prediabetes, but also effectively improve metabolic disorders and pancreatic dysfunction, thereby enhancing overall therapeutic efficacy.

[0050] Furthermore, the present invention utilizes standardized wet granulation or compression granulation processes in its preparation, significantly improving the drug's formability and compliance. Optimization of the excipient ratio and drying conditions also ensures the stability, solubility, and storage properties of the granule preparation. This composition has demonstrated excellent safety and compliance in actual clinical applications, achieving a 65.90% overall efficacy rate and a 22.54% clinical cure rate in 173 patients with prediabetes, demonstrating its potential for regulating glucose metabolism and intervening in disease progression.

[0051] In summary, the present invention not only solves the technical problems of unstable efficacy and extensive preparation process in the treatment of prediabetes with traditional Chinese medicine combination, but also realizes a new path for Chinese medicine intervention in prediabetes through multi-target and synergistic enhancement, which has significant clinical practical value and industrial promotion potential. The present invention effectively solves the technical problems of improper combination of ingredients, extensive preparation process, poor clinical consistency and other technical problems in the treatment of prediabetes with traditional Chinese medicine. Through standardized production process and quantitative control, it realizes the controllable quality and repeatable efficacy from raw material screening to finished preparation, providing a safe, effective and mature preparation process Chinese medicine intervention program for prediabetes patients, which has significant clinical application value and promotion potential.

[0052] In the description of the present application, the description with reference to the terms "one embodiment", "some embodiments", "in the present embodiment", "specific example", or "some examples" means that the specific features, mechanisms, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, mechanisms, materials or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and the features of different embodiments or examples, unless they are contradictory.

[0053] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present application should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

Claims

1. A Chinese medicine composition for treating prediabetes, characterized in that: The raw materials include the following components in parts by weight: 10-20 parts of coptis chinensis, 20-30 parts of astragalus, 20-30 parts of yam, 12-30 parts of atractylodes, 10-20 parts of perilla, 15-30 parts of stir-fried atractylodes, 15-20 parts of poria, and 10-20 parts of ophiopogon.

2. The Chinese medicine composition for treating prediabetes according to claim 1, characterized in that The Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of coptis chinensis, 20-25 parts of astragalus, 20-25 parts of yam, 12-20 parts of atractylodes, 10-15 parts of perilla, 15-20 parts of stir-fried atractylodes, 15-18 parts of poria, and 10-15 parts of ophiopogon.

3. The Chinese medicine composition for treating prediabetes according to claim 2, characterized in that The Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of coptis chinensis, 20 parts of astragalus, 20 parts of yam, 12 parts of atractylodes, 10 parts of perilla, 15 parts of stir-fried atractylodes, 15 parts of poria, and 10 parts of ophiopogon.

4. A method for preparing the traditional Chinese medicine composition for treating prediabetes according to any one of claims 1 to 3, characterized in that: The following steps are involved: S1: Weigh coptis root, astragalus root, yam, atractylodes, euphratica root, stir-fried atractylodes, poria, and ophiopogon respectively to ensure that the quality ratio of each raw material meets the requirements; S2: Grind the raw materials in step S1 into fine powder and screen to a suitable particle size; S3: The raw materials crushed in step S2 are mixed uniformly according to a certain proportion to obtain a mixed powder; S4: mixing the mixed powder obtained in step S3 with an appropriate amount of excipients, adding a solvent, and preparing a drug paste; S5: granulating the drug paste obtained in step S4 through a granulator to prepare a granular preparation; S6: drying the granule preparation obtained in step S5 until the moisture content meets the standard to ensure the stability and storage of the granules; S7: Packing the particles obtained in step S6 to obtain a granular preparation for treating prediabetes.

5. The method for preparing the Chinese medicine composition for treating prediabetes according to claim 4, wherein: In the step S2, the particle size is 80-120 mesh.

6. The method for preparing the traditional Chinese medicine composition for treating prediabetes according to claim 4, wherein: In step S4, the auxiliary materials include starch and hydroxypropyl methylcellulose.

7. The method for preparing the traditional Chinese medicine composition for treating prediabetes according to claim 4, characterized in that: In step S5, the granulation is performed by the granulator under the following conditions: compression molding or wet granulation is performed to obtain a granular preparation with a particle diameter ranging from 1 to 3 mm.

8. The method for preparing the traditional Chinese medicine composition for treating prediabetes according to claim 4, characterized in that: In step S6, the granule preparation is dried under the condition that the moisture content of the granules is ≤1.5%.

9. Use of the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The application includes the use of the traditional Chinese medicine composition in treating patients with prediabetes, and the traditional Chinese medicine composition includes dosage forms such as oral liquid, tablets, capsules, powders, and pills prepared by a drug carrier.

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