A traditional Chinese medicine formula for treating simple obesity by treating the root and removing turbidity, preparation process and application thereof

Abstract

The application discloses a traditional Chinese medicine formula for treating simple obesity by consolidating the root and removing turbidity, a preparation process and application thereof, and belongs to the technical field of traditional Chinese medicine. The formula is composed of raw astragalus, dried tangerine or orange peel, tuckahoe, fried seed of Chinese yam, gordon euryale seed, Chinese yam, lotus leaf, fried cassia seed, fried hawthorn fruit and cassia bark in a specific ratio and has the effects of benefiting qi, strengthening the spleen, removing turbidity and reducing fat. The granules prepared from the formula contain 10g of crude drug per bag and are taken twice a day after meals for 4 weeks. Clinical preliminary observation shows that the average weight of simple obesity patients is reduced by 2.39kg after taking the medicine, which is obviously better than that of the comparison group (P<0.01), and no obvious adverse reactions are found. It is proved that the formula is safe and effective, and provides a treatment scheme with definite curative effect and high compliance for simple obesity patients.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine formula, preparation process and application for treating simple obesity by strengthening the body's foundation and eliminating turbidity. Background Technology

[0002] In traditional Chinese medicine, obesity is considered a condition of deficiency in the root and excess in the branch, including spleen deficiency and indigestion, phlegm and dampness accumulation, liver qi stagnation, and spleen and kidney yang deficiency. For these patients, simply purging can easily damage the body's vital energy, while excessive clearing and draining can be bitter and cold and damage the stomach. Simply tonifying the deficiency can actually help the pathogens to stagnate, making it difficult to achieve a lasting therapeutic effect and leading to a prolonged illness.

[0003] Currently, most commercially available weight-loss Chinese medicines focus on digestion, clearing heat, and promoting diuresis. For example, formulas mainly composed of lotus leaf, hawthorn, and cassia seed (such as patent publication number: CN119857130A) have a certain lipid-lowering effect. Although these formulas contain lipid-lowering herbs such as lotus leaf and cassia seed, the entire formula is cold in nature and lacks warming and tonifying herbs for the spleen and kidneys (such as astragalus, cinnamon, and yam). Therefore, they are not suitable for patients with spleen and kidney yang deficiency syndrome, such as aversion to cold, cold limbs, loose stools, and edema, and cannot fundamentally improve yang deficiency constitution. Traditional yang-warming formulas (such as Zhenwu Decoction and Linggui Zhugan Decoction) can warm yang and promote diuresis, but they lack blood-activating and turbidity-removing herbs that target lipid stagnation, thus limiting their lipid-lowering effect.

[0004] Therefore, there is an urgent need to develop a traditional Chinese medicine composition that can both replenish deficiencies to address the root cause and eliminate turbidity and fat to address the symptoms, so as to achieve precise intervention for simple obesity. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention proposes a traditional Chinese medicine formula, preparation process, and application for treating simple obesity by strengthening the body's foundation and eliminating dampness. Based on the TCM theory of "supporting the body's resistance without retaining pathogens," and targeting the core pathogenesis of simple obesity—a deficiency in the root and an excess in the branch—this invention utilizes a scientific combination of qi-tonifying and spleen-strengthening herbs, dampness-eliminating and fat-reducing herbs, and qi-regulating and dampness-removing herbs to synergistically improve the body's constitution through multiple pathways, achieving a safe, effective, and sustainable weight loss effect.

[0006] To achieve the above objectives, the present invention provides the following technical solution: A traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight percentage: Raw Astragalus 10-15 parts, Tangerine Peel 5-10 parts, Poria 10-15 parts, Fried Coix Seed 12-18 parts, Euryale Seed 10-15 parts, Dioscorea 10-15 parts, Lotus Leaf 5-10 parts, Fried Cassia Seed 5-10 parts, Fried Hawthorn 5-10 parts, Cinnamon 3-5 parts.

[0007] The traditional Chinese medicine formula provided by this invention involves the following relationships between the principal, assistant, adjuvant, and guide herbs: I. Principal Herb: Tonifies Qi and strengthens the spleen, consolidates the foundation and nourishes the original Qi. Raw Astragalus: Sweet and warm in nature, it invigorates Qi, strengthens the spleen and raises Yang, promotes diuresis and reduces swelling. As a key Qi-tonifying herb, it significantly enhances the spleen's digestive function, promotes the distribution of nutrients, and eliminates the source of phlegm and dampness, making it the core of the entire formula for strengthening the body's resistance. Astragaloside A and polysaccharides in Astragalus can improve glucose and lipid metabolism disorders; its diuretic effect helps alleviate water and sodium retention-type obesity, while simultaneously inhibiting fat synthesis and promoting fat decomposition, demonstrating clear anti-obesity potential.

[0008] Roasted Job's tears: Sweet, bland, and slightly cold in nature, the roasting process greatly reduces its cold properties and enhances its spleen-strengthening and dampness-removing effects. When used in conjunction with astragalus, it works synergistically to invigorate qi, strengthen the spleen, and promote diuresis and reduce swelling, aiding digestion and preventing the accumulation of phlegm. Job's tears are rich in coixol, polysaccharides, and unsaturated fatty acids, exhibiting significant lipid-lowering, anti-inflammatory, and gut microbiota-regulating effects. Its extracts can inhibit adipocyte differentiation, reduce visceral fat accumulation, and roasting further facilitates the dissolution of fat-soluble active ingredients, improving bioavailability.

[0009] Second, the auxiliary herbs: strengthen the spleen and eliminate dampness, tonify the kidneys and aid digestion. Poria cocos: sweet, bland, and neutral in nature; it promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It assists Astragalus membranaceus and Coix lacryma-jobi in enhancing their dampness-eliminating effects without harming the body's vital energy. Poria cocos polysaccharides and its triterpenoid components (such as pachymic acid) have anti-inflammatory and antioxidant effects, and can improve liver lipid deposition induced by a high-fat diet.

[0010] Yam and fox nut: Both are sweet and neutral in nature, entering the spleen and kidney meridians. Yam nourishes the spleen and stomach, benefits the lungs and generates fluids, and tonifies the kidneys and astringes essence; fox nut strengthens the spleen and stops diarrhea, and tonifies the kidneys and consolidates essence. The combination of these two herbs not only helps the spleen transform and transport fluids, but also consolidates the lower body, preventing excessive diuresis from depleting kidney qi, embodying the principle of "diuresis without forgetting to strengthen the kidneys." The diosgenin and mucoprotein in yam, and the polyphenols and flavonoids in fox nut, all have antioxidant and lipid metabolism-regulating effects. Together, they can stabilize metabolic homeostasis and prevent muscle loss or electrolyte imbalance during weight loss.

[0011] III. Adjuvant herbs: dispel turbidity and reduce fat, regulate qi and promote blood circulation. Lotus leaf: Bitter and neutral in nature, it promotes the ascent of clear qi and the descent of turbid qi, clears heat and promotes diuresis. Modern pharmacology has confirmed its significant lipid-lowering and weight-loss effects. In this formula, it guides the clear yang qi upward and promotes the descent of turbid yin qi, thus aiding in lipid metabolism. The lotus leaf alkaloids and flavonoids in lotus leaves can inhibit fat absorption, promote cholesterol excretion, and accelerate triglyceride decomposition by activating the PPARα pathway to upregulate lipoprotein lipase expression. It is a recognized natural lipid-lowering and weight-loss component.

[0012] Roasted hawthorn and roasted cassia seeds: Hawthorn aids digestion, promotes blood circulation, and removes blood stasis; cassia seeds clear the liver, improve eyesight, and lubricate the intestines to relieve constipation. Roasting both mitigates their cold and slippery properties, focusing on their fat-reducing, blood-activating, and bowel-regulating effects. This addresses existing fat stagnation and obstruction, achieving a "treat the root cause, treat the root cause" approach. The flavonoids (such as quercetin and hyperoside) and organic acids (such as citric acid and malic acid) in hawthorn can significantly reduce serum total cholesterol (TC) and triglyceride (TG) levels and inhibit the activity of 3-hydroxy-3-methylglutaryl-CoA reductase (HMG-CoA reductase). The rhein and emodin methyl ether in cassia seeds have a mild laxative effect, promoting bile acid excretion and indirectly reducing cholesterol synthesis. Roasting moderates their cold and slippery properties, reducing damage to the spleen and stomach's yang energy, making them more suitable for long-term use by patients with spleen and kidney yang deficiency.

[0013] Dried tangerine peel: Bitter, pungent, and warm in nature, it regulates qi, strengthens the spleen, dries dampness, and resolves phlegm. When qi flows smoothly, dampness is transformed; when the spleen functions properly, phlegm is eliminated. Dried tangerine peel regulates the qi mechanism of the middle jiao, ensuring the entire formula is nourishing without stagnation and beneficial without being harsh, making it a key harmonizing ingredient. Hesperidin and nobiletin in dried tangerine peel have anti-inflammatory, antioxidant, and intestinal motility-regulating functions, which can improve symptoms of metabolic syndrome such as bloating and constipation, and synergistically enhance the lipid metabolism-regulating effects of other drugs.

[0014] IV. The guiding herb: warms the kidneys and assists yang, while acting as a counteracting agent to prevent adverse effects. Cinnamon: pungent, sweet, and very hot in nature, it replenishes the fire of the gate of life (Mingmen), warms and unblocks the meridians, and guides fire back to its source. A small amount of cinnamon in this formula has a triple effect: (1) Warming and tonifying kidney yang, assisting bladder qi transformation to promote diuresis and reduce swelling; (2) Counteract the slightly cold nature of lotus leaf, cassia seed and other slightly cold products to prevent the coldness from damaging the yang of the spleen and kidney; (3) It promotes the circulation of qi and blood, and enhances the blood-activating and stasis-removing effects of hawthorn.

[0015] In this invention, the amount of cinnamon used in the formula is relatively light (3-5 parts), taking the meaning of "a little fire generates qi," which can warm and transform yang qi without causing excessive heat or damaging yin. Cinnamaldehyde in cinnamon is its core active ingredient, which can increase thermogenesis in brown adipose tissue and reduce obesity-related chronic low-grade inflammation. In addition, cinnamaldehyde can also enhance insulin signaling and improve glucose and lipid metabolism.

[0016] Optionally, the traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight percentage: 12 parts raw astragalus, 9 parts dried tangerine peel, 12 parts poria cocos, 15 parts stir-fried coix seed, 12 parts euryale seed, 12 parts yam, 9 parts lotus leaf, 6 parts stir-fried cassia seed, 6 parts stir-fried hawthorn, and 3 parts cinnamon.

[0017] Optionally, the traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight percentage: 10 parts raw astragalus, 5 parts dried tangerine peel, 10 parts poria cocos, 12 parts stir-fried coix seed, 10 parts euryale seed, 10 parts yam, 5 parts lotus leaf, 5 parts stir-fried cassia seed, 5 parts stir-fried hawthorn, and 3 parts cinnamon.

[0018] Optionally, the traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight percentage: 15 parts raw astragalus, 10 parts dried tangerine peel, 15 parts poria cocos, 18 parts stir-fried coix seed, 15 parts euryale seed, 15 parts yam, 10 parts lotus leaf, 10 parts stir-fried cassia seed, 10 parts stir-fried hawthorn, and 5 parts cinnamon.

[0019] The preparation process of the above-mentioned traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following steps: Weigh the raw materials according to the specified weight proportions, then grind them into powder, pass them through an 80-mesh sieve, and mix them evenly.

[0020] The above-mentioned traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity is applied in the preparation of drugs for treating simple obesity.

[0021] A drug for treating simple obesity by strengthening the body's foundation and eliminating turbidity, the active ingredients of which include the above-mentioned traditional Chinese medicine formula.

[0022] Optionally, the drug may be in the form of granules, tablets, capsules, powders, oral liquids, decoctions, or pills.

[0023] Furthermore, the drug is in granule form.

[0024] The above-mentioned method of using the drug to treat simple obesity by strengthening the body's foundation and eliminating turbidity includes the following steps: twice a day, each time the dosage is 10g of raw herbs, and the treatment course is 4 weeks.

[0025] Compared with the prior art, the present invention has the following advantages and technical effects: 1. Highly compatible with the pathogenesis: This invention organically combines "warming and tonifying the spleen and kidneys" with "resolving turbidity, eliminating fat and promoting blood circulation", precisely targeting the complex pathogenesis of spleen and kidney yang deficiency as the root cause and phlegm, dampness and blood stasis as the symptoms, breaking through the limitations of existing weight loss formulas that "emphasize attacking and neglect tonifying" or "emphasize tonifying without attacking".

[0026] 2. The raw materials specified in this invention exhibit synergistic effects when combined, as detailed below: Astragalus, Dioscorea, Euryale ferox, and stir-fried Coix seed → strengthen the spleen, eliminate dampness, and protect the middle jiao; Cinnamon → In small amounts, it warms the kidneys and invigorates yang, stimulates qi transformation, and promotes the transportation and transformation of water and dampness; Lotus leaf, stir-fried hawthorn, and stir-fried cassia seed → promote the upward movement of clear qi and the downward movement of turbid qi, eliminate stagnation and reduce fat; Poria cocos and dried tangerine peel → regulate qi and strengthen the spleen, eliminating the source of phlegm.

[0027] This invention is characterized by its gentle yet not drying properties, its nourishing yet not stagnant properties, and its ability to eliminate toxins without being harsh. Detailed Implementation

[0028] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0029] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Every smaller range between any stated value or intermediate value within a stated range, and any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0030] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0031] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be readily apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0032] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0033] This invention discloses a traditional Chinese medicine composition for treating simple obesity, comprising the following raw materials in parts by weight: Raw Astragalus 10-15 parts, Tangerine Peel 5-10 parts, Poria 10-15 parts, Fried Coix Seed 12-18 parts, Euryale Seed 10-15 parts, Dioscorea 10-15 parts, Lotus Leaf 5-10 parts, Fried Cassia Seed 5-10 parts, Fried Hawthorn 5-10 parts, Cinnamon 3-5 parts.

[0034] In some optional embodiments, the formulation and weight parts of the traditional Chinese medicine composition are as follows: 12 parts raw astragalus, 9 parts dried tangerine peel, 12 parts poria cocos, 15 parts stir-fried coix seed, 12 parts euryale seed, 12 parts yam, 9 parts lotus leaf, 6 parts stir-fried cassia seed, 6 parts stir-fried hawthorn, and 3 parts cinnamon.

[0035] In some alternative embodiments, the traditional Chinese medicine composition may be prepared into oral formulations according to conventional methods in the art, including but not limited to granules, tablets, capsules, powders, oral liquids or pills.

[0036] Unless otherwise specified, "room temperature" in this invention refers to 20-30℃.

[0037] Unless otherwise specified, the term "parts" in this invention refers to parts by weight.

[0038] All raw materials used in this invention were purchased from the market.

[0039] The technical solution of the present invention will be further illustrated by the following embodiments.

[0040] Example 1 A traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight: 10 parts raw astragalus, 5 parts dried tangerine peel, 10 parts poria cocos, 12 parts stir-fried coix seed, 10 parts euryale seed, 10 parts yam, 5 parts lotus leaf, 5 parts stir-fried cassia seed, 5 parts stir-fried hawthorn, and 3 parts cinnamon.

[0041] The preparation method of the oral granule preparation containing the above-mentioned traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following steps: Weigh the above raw materials according to the specified weight proportions, then grind them into powder, pass them through an 80-mesh sieve, and mix them evenly. Prepare a soft mass from the evenly mixed powder (place the powder in a mixer, and slowly add 55 vol% ethanol as a wetting agent / binder while stirring; the amount of ethanol added should be 20%–40% of the total weight of the powder (30% is selected in this embodiment). Continue stirring until the powder can be formed into a ball by hand and crumbles easily when pressed), forming a soft mass with suitable moisture content. Prepare wet granules (pass the prepared soft mass through a gyratory granulator, using a 14-mesh sieve for forced extrusion). The process involves several steps: sieving, drying (the wet granules are quickly placed in an oven for drying. The drying temperature is generally controlled at 60-80℃ to prevent the surface of the granules from drying too quickly and forming a crust, ensuring that the internal moisture is fully evaporated), granulation (the dried granules are granulated through a No. 1 sieve (12-14 mesh) to break up clumps; then through a No. 4 sieve (60 mesh) to remove fine powder and small particles, thus obtaining granules with uniform particle size and meeting specifications), and packaging (the qualified granules are packaged according to dosage and sealed in aluminum-plastic composite bags to prevent moisture absorption and volatilization of active ingredients), thus obtaining an oral granule preparation containing the above-mentioned traditional Chinese medicine formula.

[0042] Example 2 The difference from Example 1 is that a traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight: 12 parts raw astragalus, 9 parts dried tangerine peel, 12 parts poria cocos, 15 parts stir-fried coix seed, 12 parts euryale seed, 12 parts yam, 9 parts lotus leaf, 6 parts stir-fried cassia seed, 6 parts stir-fried hawthorn, and 3 parts cinnamon.

[0043] Example 3 The difference from Example 1 is that a traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight: 15 parts raw astragalus, 10 parts dried tangerine peel, 15 parts poria cocos, 18 parts stir-fried coix seed, 15 parts euryale seed, 15 parts yam, 10 parts lotus leaf, 10 parts stir-fried cassia seed, 10 parts stir-fried hawthorn, and 5 parts cinnamon.

[0044] Example 4 The difference from Example 1 lies in the preparation process. A method for preparing a traditional Chinese medicine decoction for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following steps: 1. Soaking Place the above-mentioned medicinal materials (except cinnamon) into a clay pot or stainless steel pot, add clean cold water, and the water level should be about 2-3 cm above the surface of the medicinal materials.

[0045] Soaking time: Soak at room temperature for 30 minutes to allow the herbs to fully absorb water, which is beneficial for the extraction of active ingredients.

[0046] 2. First decoction Place the soaked herbs and soaking water on a stove and bring to a boil over high heat. After boiling, add cinnamon (cinnamon contains volatile oils, so it should be added later to reduce the loss of active ingredients). Reduce the heat to low and simmer for 20 minutes, maintaining a gentle boil. After simmering, filter the liquid while it is still hot through double-layered gauze or a strainer to collect the liquid.

[0047] 3. Second decoction Return the dregs from the first decoction to the pot and add 400mL of warm water. Bring to a boil over high heat, then simmer over low heat for another 20 minutes. Filter out the liquid and combine the two decoctions. This yields a traditional Chinese medicine decoction containing the above-mentioned herbal formula.

[0048] In addition, the present invention discloses a drug for treating simple obesity by strengthening the body's foundation and eliminating turbidity. The drug includes, but is not limited to, granules, tablets, capsules, powders, oral liquids, decoctions or pills. In the same formulation, the efficacy of various dosage forms is the same or similar, only the preparation process and form are different.

[0049] Comparative Example 1 A traditional Chinese medicine formula for treating simple obesity, which only has the effect of clearing away turbidity and has no effect of strengthening the body's foundation, includes the following ingredients by weight: 5 parts dried tangerine peel, 10 parts Poria cocos, 12 parts stir-fried coix seed, 10 parts Euryale ferox, 10 parts Dioscorea opposita, 5 parts lotus leaf, 5 parts stir-fried cassia seed, and 5 parts stir-fried hawthorn.

[0050] The preparation method of the oral granule preparation containing the above-mentioned traditional Chinese medicine formula for treating simple obesity by clearing away turbidity includes the following steps: Weigh the above raw materials according to the specified weight proportions, then grind them into powder, pass them through an 80-mesh sieve, and mix them evenly. Prepare a soft mass by placing the evenly mixed powder in a mixer and slowly adding 55% vol% ethanol as a wetting agent / binder while stirring. The amount of ethanol added should be 30% of the total weight of the powder. Continue stirring until the powder can be formed into a ball by hand and crumbles easily when lightly pressed, forming a soft mass with suitable moisture content. Then, prepare wet granules by passing the prepared soft mass through a gyratory granulator using a 14-mesh sieve. Finally, dry the wet granules. The granules are quickly placed in an oven for drying. The drying temperature is generally controlled at 60-80℃ to prevent the surface of the granules from drying too quickly and forming a crust, ensuring that the internal moisture evaporates fully. The granules are then sized (passed through a No. 1 sieve (12-14 mesh) to break up clumps; then passed through a No. 4 sieve (60 mesh) to remove fine powder and small particles, thus obtaining granules with uniform particle size and conforming to specifications). The qualified granules are then packaged according to dosage and sealed in aluminum-plastic composite bags to prevent moisture absorption and volatilization of active ingredients, thus obtaining an oral granule preparation containing the above-mentioned traditional Chinese medicine formula.

[0051] Comparative Example 2 The difference from Example 2 is that a traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight: 9 parts dried tangerine peel, 12 parts Poria cocos, 15 parts stir-fried coix seed, 12 parts Euryale ferox, 12 parts Dioscorea opposita, 9 parts lotus leaf, 6 parts stir-fried cassia seed, and 6 parts stir-fried hawthorn.

[0052] Comparative Example 3 The difference from Example 3 is that a traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity includes the following ingredients by weight: 10 parts dried tangerine peel, 15 parts Poria cocos, 18 parts stir-fried coix seed, 15 parts Euryale ferox, 15 parts Dioscorea opposita, 10 parts lotus leaf, 10 parts stir-fried cassia seed, and 10 parts stir-fried hawthorn.

[0053] Effect verification (1) Inclusion criteria: Subjects must meet the following conditions: (a) age 18-65 years, gender not limited; (b) meet the diagnostic criteria for simple obesity in traditional Chinese medicine (refer to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines"); (c) sign informed consent form, voluntarily participate and cooperate with follow-up.

[0054] (2) Exclusion criteria: Individuals meeting any of the following criteria will not be included: (a) those with serious heart, liver, kidney, endocrine, or mental disorders; (b) those who are pregnant, breastfeeding, or planning to become pregnant during the trial; (c) those who have received other weight-loss drugs or surgical interventions within the past 3 months; (d) those who are allergic to any component of this composition; (e) those with poor adherence and unable to complete the course of treatment; and (f) those with a history of alcoholism, drug abuse, or other conditions that may interfere with the evaluation of efficacy.

[0055] (3) Administration method: Use the oral granules of the composition prepared in Example 2 and Comparative Example 2 of this invention, one bag each time (containing 10g of raw medicinal material), twice a day, after breakfast and dinner, dissolved in warm water, for a course of treatment of 4 consecutive weeks.

[0056] (4) Safety monitoring Vital signs were recorded regularly during treatment, and blood routine tests, liver and kidney function tests, and other indicators were monitored. Results showed that no significant adverse reactions occurred in the experimental group, and all subjects completed the treatment, indicating that the composition had good safety. Specific weight change data are shown in Table 1.

[0057] Table 1: Effects of the herbal composition of the present invention on the weight of patients with simple obesity As shown in Table 1, in a preliminary randomized controlled clinical observation (n=36), the experimental group (n=18) experienced an average weight loss of 2.39±1.94 kg (P<0.001) after taking the oral granules of the composition prepared in Example 2 of this invention for 4 weeks; the comparative group (n=18) experienced a weight loss of only 0.85±1.03 kg during the same period (P=0.003). The difference in weight loss between the two groups was highly statistically significant (P<0.01), indicating that the traditional Chinese medicine composition disclosed in this invention is significantly effective in improving obesity caused by spleen and kidney yang deficiency, and no obvious adverse reactions were observed.

[0058] The above are merely preferred embodiments of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and eliminating turbidity, characterized in that, By weight percentage, it includes the following raw materials: Raw Astragalus 10-15 parts, Tangerine Peel 5-10 parts, Poria 10-15 parts, Fried Coix Seed 12-18 parts, Euryale Seed 10-15 parts, Dioscorea 10-15 parts, Lotus Leaf 5-10 parts, Fried Cassia Seed 5-10 parts, Fried Hawthorn 5-10 parts, Cinnamon 3-5 parts.

2. The traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and resolving turbidity, as described in claim 1, is characterized in that... By weight percentage, it includes the following raw materials: 12 parts raw astragalus, 9 parts dried tangerine peel, 12 parts poria cocos, 15 parts stir-fried coix seed, 12 parts euryale seed, 12 parts yam, 9 parts lotus leaf, 6 parts stir-fried cassia seed, 6 parts stir-fried hawthorn, and 3 parts cinnamon.

3. The traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and resolving turbidity, as described in claim 1, is characterized in that... By weight percentage, it includes the following raw materials: 10 parts raw astragalus, 5 parts dried tangerine peel, 10 parts poria cocos, 12 parts stir-fried coix seed, 10 parts euryale seed, 10 parts yam, 5 parts lotus leaf, 5 parts stir-fried cassia seed, 5 parts stir-fried hawthorn, and 3 parts cinnamon.

4. A traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and resolving turbidity, as described in claim 1, is characterized in that... By weight percentage, it includes the following raw materials: 15 parts raw astragalus, 10 parts dried tangerine peel, 15 parts poria cocos, 18 parts stir-fried coix seed, 15 parts euryale seed, 15 parts yam, 10 parts lotus leaf, 10 parts stir-fried cassia seed, 10 parts stir-fried hawthorn, and 5 parts cinnamon.

5. A preparation process of a traditional Chinese medicine formula for treating simple obesity by strengthening the body's foundation and resolving turbidity, as described in any one of claims 1-4, characterized in that... Includes the following steps: Weigh the raw materials according to the specified weight proportions, then grind them into powder, pass them through an 80-mesh sieve, and mix them evenly.

6. The use of a traditional Chinese medicine formula as described in any one of claims 1-4 in the preparation of a drug for treating simple obesity.

7. A drug for treating simple obesity by strengthening the body's foundation and eliminating turbidity, characterized in that, The active ingredients include the traditional Chinese medicine formula as described in any one of claims 1-4.

8. A drug for treating simple obesity by strengthening the body's foundation and eliminating turbidity, as described in claim 7, characterized in that... The drugs include granules, tablets, capsules, powders, oral liquids, decoctions, or pills.

9. A drug for treating simple obesity by strengthening the body's foundation and eliminating turbidity, as described in claim 8, characterized in that... The drug is in granule form.

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