Traditional Chinese medicine composition for obesity and overweight people of spleen deficiency and dampness-heat type and preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for people with obesity and overweight of spleen deficiency and damp-heat type and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: Gualou 40-60 parts, Yiyiren 30-50 parts, Fuling 80-110 parts, Zhizi 10-20 parts, Renshen 1-5 parts and Huangjing 5-10 parts. The Gualou, Yiyiren and Fuling are used as monarch drugs to invigorate the spleen and eliminate dampness, the Zhizi is used as a minister drug to clear heat and drain dampness, the Renshen and Huangjing are used to tonify qi and nourish yin, support the root of spleen deficiency, and make up for the bitter cold of the Zhizi to hurt the stomach, so that the traditional Chinese medicine composition can achieve the functions of invigorating the spleen and eliminating dampness, clearing heat and tonifying qi, and treat the root and branch of the people with obesity and overweight of spleen deficiency and damp-heat type according to the pathogenesis characteristics of the spleen deficiency as the root and the damp-heat as the branch. The application has a simple formula, mild medicinal properties, and is suitable for long-term taking. The application further provides a preparation method of the traditional Chinese medicine composition, which can be prepared into a decoction, granules, capsules, tablets, pills or oral liquid, and has the advantages of simple preparation process, stable product quality and convenient taking.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition for obese and overweight people with spleen deficiency and damp-heat type and its preparation method. Background Technology

[0002] Obesity refers to weight gain caused by excessive accumulation or abnormal distribution of body fat. It is a chronic metabolic disease resulting from the combined effects of multiple factors, including genetics, environment, and metabolism. In recent years, with changes in lifestyle and dietary structure, the incidence of obesity has continued to rise globally, becoming a significant public health problem threatening human health. Obesity not only affects physical appearance but is also closely related to various diseases such as type 2 diabetes, hypertension, coronary heart disease, hyperlipidemia, non-alcoholic fatty liver disease, and sleep apnea syndrome, severely reducing patients' quality of life and increasing the medical burden.

[0003] Currently, Chinese herbal weight loss products on the market are mainly divided into two categories: one category uses bitter and cold purgatives or strong diuretics (such as rhubarb, senna leaves, cassia seeds, etc.), which can be effective in the short term, but can easily damage the spleen and stomach's vital energy, deplete qi and yin, and lead to "the more you lose weight, the weaker you become"; the other category focuses on strengthening the spleen and removing dampness, and is mostly targeted at the syndrome of "spleen deficiency and dampness" or "phlegm and dampness", using drugs such as ginseng, poria, atractylodes, and licorice.

[0004] In recent years, some products have recognized the pathogenesis of obesity as a mixture of deficiency and excess, and have adopted a combined approach of attacking and tonifying, while also incorporating diuretics, expectorants, blood-activating agents, and spleen-strengthening and qi-tonifying agents. However, these products generally have problems such as complex formulations (usually 10 to 20 kinds of medicinal materials), numerous ingredients, high costs, and heavy burden on patients. In addition, most existing products are positioned as "medicines" and lack the design as "meal replacements" or daily supplements. They have not optimized the feeling of fullness for meal replacement scenarios, and some products still contain laxative ingredients, making them unsuitable for long-term use.

[0005] More importantly, the inventors have observed in long-term clinical practice that the syndrome characteristics of contemporary overweight and obese people have changed. Affected by a variety of factors such as high sugar and high fat diet, fast-paced life, and mental stress, most patients do not simply have "spleen deficiency and dampness". Instead, they have both spleen deficiency and damp heat. They have symptoms of spleen deficiency such as fatigue and abdominal distension, as well as symptoms of damp heat such as dry mouth and bitter taste, sticky and uncomfortable stool, red tongue with yellow and greasy coating. Existing products lack a simple, safe and long-term treatment plan specifically for the complex pathogenesis of "spleen deficiency and damp heat".

[0006] To address these issues, we provide a traditional Chinese medicine composition and its preparation method for obese and overweight individuals with spleen deficiency and damp-heat syndrome. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition and its preparation method for obese and overweight people with spleen deficiency and damp-heat type. Through the synergistic effect of multiple traditional Chinese medicines, it can simultaneously achieve multiple effects such as strengthening the spleen and replenishing qi, removing dampness and promoting diuresis, and clearing heat and relieving irritability, so as to achieve the purpose of treating both the symptoms and the root cause, and being safe and effective.

[0008] To solve the above-mentioned technical problems, the present invention is achieved through the following technical solution:

[0009] This invention relates to a traditional Chinese medicine composition for obese and overweight individuals with spleen deficiency and damp-heat type, which is made from the following raw materials in parts by weight: 40-60 parts of Euryale ferox, 30-50 parts of Coix lacryma-jobi, 80-110 parts of Poria cocos, 10-20 parts of Gardenia jasminoides, 1-5 parts of Ginseng, and 5-10 parts of Polygonatum sibiricum.

[0010] The present invention is further configured to be made from the following raw materials in parts by weight: 45-55 parts of Euryale ferox, 35-45 parts of Coix lacryma-jobi, 85-105 parts of Poria cocos, 12-18 parts of Gardenia jasminoides, 2-4 parts of Ginseng, and 6-9 parts of Polygonatum sibiricum.

[0011] The present invention is further configured to be made from the following raw materials in parts by weight: 54 parts of Euryale ferox, 40 parts of Coix lacryma-jobi, 100 parts of Poria cocos, 15 parts of Gardenia jasminoides, 3 parts of Ginseng, and 6 parts of Polygonatum sibiricum.

[0012] The present invention is further configured such that the Polygonatum is obtained by the following method:

[0013] Take clean Polygonatum sibiricum, add 20 kg of rice wine for every 100 kg of Polygonatum sibiricum, mix well, let it soak until the wine is absorbed, steam until thoroughly cooked, take it out, cut it into thick slices, and dry it.

[0014] The gardenia fruit was obtained through the following processing method:

[0015] Take cleaned gardenia fruits and stir-fry them over low heat until the surface turns golden yellow;

[0016] The Job's tears are prepared by the following method: take wheat bran and heat it until it smokes, add clean Job's tears, the mass ratio of Job's tears to wheat bran is 100:15, stir-fry until the surface is slightly yellow;

[0017] The fox nuts are prepared by the following method: heat wheat bran until it smokes, add clean fox nuts, the mass ratio of fox nuts to wheat bran is 100:10-15, stir-fry until the surface is slightly yellow.

[0018] This invention also provides a method for preparing a traditional Chinese medicine composition for obese and overweight individuals with spleen deficiency and damp-heat type, comprising the following steps:

[0019] S1: Weigh out the processed Euryale ferox, Coix lacryma-jobi, Poria cocos, Gardenia jasminoides, Ginseng, and Polygonatum sibiricum according to their respective weight parts;

[0020] S2: Each herb is decocted separately with water, with the amount of water added each time being 6-24 times the amount of the herb. The extraction time is 0.5-3.5 hours, and the extraction is repeated 1-2 times. The decoction is decocted under normal pressure, and the decoctions of each herb are combined and filtered.

[0021] S3: The filtrates of each medicinal material are concentrated under reduced pressure at a temperature of 50-90℃ until the relative density is 1.00-1.40, thus obtaining the extracts of each medicinal material.

[0022] S4: Add each extract to the excipients separately, granulate by dry method, sieve and granulate, collect particles between 16-40 mesh, dry to moisture content ≤5.0%, and obtain dried granules of each medicinal material.

[0023] S5: Weigh the dried granules of each medicinal material according to the formula ratio, mix them evenly, and you will get the Chinese medicine composition granules.

[0024] The present invention is further configured such that the filtration in S2 adopts a single or double filtration method, and the filter screen specification is 60-300 mesh.

[0025] The present invention is further configured such that the excipients in S4 include maltodextrin and silicon dioxide.

[0026] The present invention is further configured such that the mixing time in S5 is 15-60 minutes, until the color is uniform and there are no spots.

[0027] The present invention is further configured such that the dosage form of the traditional Chinese medicine composition is granules, capsules, tablets, oral liquids or pills.

[0028] The present invention has the following beneficial effects:

[0029] 1. This invention is composed of six core medicinal materials: ginseng, polygonatum, gardenia, euryale seed, poria cocos, and coix seed. The formula is concise, the medicinal materials are widely available, the production cost is low, and the patient compliance is good.

[0030] 2. This invention uses ginseng and polygonatum to invigorate the spleen and replenish qi to treat the root cause, gardenia to clear heat and promote diuresis to treat the symptoms, and poria, coix seed, and euryale seed to remove dampness without harming the body's vital energy. The whole formula combines attack and tonification, and balances cold and heat, precisely matching the complex pathogenesis of spleen deficiency and damp heat, thus achieving significant weight loss effect.

[0031] 3. The ingredients in this invention, such as Poria cocos, Coix seed, and Euryale ferox, are rich in polysaccharides and dietary fiber. After swelling in water, they can provide a lasting feeling of fullness. Clinical observations show that patients taking this invention experience significantly less hunger on fasting days than those in the simple diet control group, thereby improving the completion rate of the weight loss program.

[0032] 4. This invention can be made into various dosage forms such as granules, capsules, tablets, oral liquids, and pills to meet the needs of different patients. Taking granules as an example, they only need to be dissolved in hot water when taken, without the need for decoction, which is convenient to use and has high patient acceptance.

[0033] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Attached Figure Description

[0034] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0035] Figure 1 This is a flowchart of the preparation method of the traditional Chinese medicine composition. Detailed Implementation

[0036] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0037] Example 1 (Standard Formulation)

[0038] Please see Figure 1 This embodiment provides a traditional Chinese medicine composition granule for obese and overweight individuals with spleen deficiency and damp-heat type.

[0039] Formula: 54 parts of Euryale ferox, 40 parts of Coix lacryma-jobi, 100 parts of Poria cocos, 15 parts of Gardenia jasminoides, 3 parts of Ginseng, and 6 parts of Polygonatum sibiricum. The above is the formula for one dose (one-day supply), which can be scaled up according to the production scale.

[0040] Preparation method:

[0041] S1: Weigh out the processed Euryale ferox, Coix lacryma-jobi, Poria cocos, Gardenia jasminoides, Ginseng, and Polygonatum sibiricum according to their respective weight parts;

[0042] S2: Each herb is decocted separately with water, with the amount of water added each time being 6-24 times the amount of the herb. The extraction time is 0.5-3.5 hours, and the extraction is repeated 1-2 times. The decoction is carried out under normal pressure. The decoctions of each herb are combined separately and allowed to stand for about 2 hours to allow fine particles to precipitate. The supernatant is then filtered through a 200-mesh plate and frame filter to obtain a clear filtrate.

[0043] S3: Transfer the clarified filtrate into a vacuum concentration tank, turn on the vacuum pump to make the vacuum degree inside the tank reach -0.08MPa, and heat it by passing hot water (60±2℃) through the jacket. Concentrate under reduced pressure at 60℃. The evaporated water vapor is recovered by the condenser. When the volume of the concentrate decreases significantly and obvious wall adhesion occurs, take a small amount of concentrate and measure its relative density with a hydrometer. When the relative density measured at 60℃ reaches 1.20-1.25, stop the concentration to obtain a brownish-brown thick extract.

[0044] S4: Transfer the extract to a trough mixer, add the pre-mixed excipients at a ratio of 1:0.5 (extract to total mass). Turn on the mixer and stir for about 15 minutes until the materials are evenly mixed and form a soft material of moderate hardness. Then, granulate the soft material through a swaying pellet mill to obtain wet granules. Subsequently, spread the wet granules evenly on the drying trays of a hot air circulating oven for drying. Stop drying when the moisture content of the granules is ≤5.0%.

[0045] S5: Weigh the dried granules of each medicinal material according to the formula ratio, mix them evenly, and you will get the Chinese medicine composition granules.

[0046] Dosage instructions:

[0047] As one specific implementation method, the herbal composition of this invention is used in conjunction with an intermittent fasting regimen. For example, a "5+2 intermittent fasting" pattern is adopted: two non-consecutive days are selected each week as fasting days. On the fasting days, 500-600 kcal of calories are consumed, and one packet of this product is dissolved in 200 mL of hot water and taken with the low-calorie meal (e.g., a meal consisting of a moderate amount of vegetables and a small amount of high-quality protein with approximately 150-200 kcal) during breakfast, lunch, and dinner on the fasting days; the remaining 5 days are for normal eating without taking this product.

[0048] Effects of use:

[0049] The trial was conducted on 61 patients for 4-8 weeks, with 35 patients completing the 8-week intervention (completion rate 57.4%). All enrolled patients were included in the analysis using the carry-over method based on the last observation. Changes in efficacy indicators were as follows: average weight loss of (4.40±2.78) kg, body mass index decrease of (1.64±1.01) kg / m², waist circumference decrease of (4.25±3.03) cm, hip circumference decrease of (2.34±1.66) cm, body fat mass decrease of (2.92±2.18) kg, body fat percentage decrease of (1.74±1.64)%, visceral fat grade decrease of 1.37±1.20, patients reported increased satiety and reduced fatigue, and no adverse reactions.

[0050] Example 2 (Ginseng Dosage Formulation)

[0051] This embodiment increases the amount of ginseng compared to embodiment 1;

[0052] Specifically,

[0053] Formula: 54 parts Euryale ferox, 40 parts Coix lacryma-jobi, 100 parts Poria cocos, 15 parts Gardenia jasminoides, 5 parts Ginseng, and 6 parts Polygonatum sibiricum. The above is the formula for one dose (one-day supply), which can be scaled up according to the production scale.

[0054] Preparation method: Same as in Example 1.

[0055] Dosage: Same as in Example 1.

[0056] Effects of use:

[0057] The trial was conducted on 15 patients for 4-8 weeks, with 8 patients completing the 8-week intervention (completion rate 53.3%). All enrolled patients were included in the analysis using the carry-over method based on the last observation. Changes in efficacy indicators are as follows:

[0058] The average weight decreased by (2.39±1.27) kg, body mass index decreased by (0.93±0.47) kg / m², waist circumference decreased by (2.49±2.27) cm, hip circumference decreased by (1.39±0.96) cm, body fat mass decreased by (1.69±1.30) kg, body fat percentage decreased by (1.14±1.7)%, and visceral fat grade decreased by 0.73±1.16.

[0059] Compared with Example 1, Example 2 showed lower weight loss, body mass index reduction, and body fat mass reduction (P < 0.05), while waist circumference reduction, hip circumference reduction, body fat percentage reduction, and visceral fat grade reduction were comparable to Example 1 (P > 0.05). Patients tolerated the treatment well and reported significantly reduced fatigue and more energy on fasting days. This suggests that appropriately increasing the ginseng dosage can reduce fatigue on fasting days, but the standard dosage can meet the needs of most patients, and is also lower in cost and safer.

[0060] Example 3 (Gardenia with increased dosage formula)

[0061] This embodiment increases the amount of gardenia compared to embodiment 1;

[0062] Specifically,

[0063] Formula: 54 parts of Euryale ferox, 40 parts of Coix lacryma-jobi, 100 parts of Poria cocos, 20 parts of Gardenia jasminoides, 3 parts of Ginseng, and 6 parts of Polygonatum sibiricum. The above is the formula for one dose (one-day supply), which can be scaled up according to the production scale.

[0064] Preparation method: Same as in Example 1.

[0065] Dosage: Same as in Example 1.

[0066] Effects of use:

[0067] The trial was conducted on 12 patients for 4-8 weeks, with 5 patients completing the 8-week intervention (completion rate 41.6%). All enrolled patients were included in the analysis using the carry-over method based on the last observation. The average weight loss was (1.90±2.02) kg, body mass index decreased by (0.65±0.88) kg / m², waist circumference decreased by (2.01±2.77) cm, hip circumference decreased by (0.98±1.14) cm, body fat mass decreased by (1.66±2.48) kg, body fat percentage decreased by (3.82±9.28)%, and visceral fat grade decreased by 1.75±3.96.

[0068] Compared with Example 1, Example 3 showed lower reductions in weight, body mass index, and body fat mass (P < 0.05), while reductions in waist circumference, hip circumference, body fat percentage, and visceral fat grade were comparable to Example 1 (P > 0.05). Patients reported more significant improvement in dry mouth and bitter taste, and a marked improvement in sticky stools, suggesting that appropriately increasing the dosage of gardenia can enhance its heat-clearing and dampness-removing effects without increasing adverse reactions.

[0069] Comparative Example 1 (White Hyacinth Bean replaces Poria cocos)

[0070] This embodiment is based on embodiment 1, but uses white hyacinth bean to replace poria cocos in a 5:3 ratio;

[0071] Specifically,

[0072] Formula: 54 parts of Euryale ferox, 40 parts of Coix lacryma-jobi, 60 parts of white hyacinth bean, 15 parts of Gardenia jasminoides, 3 parts of ginseng, and 6 parts of Polygonatum sibiricum. The above is the formula for one dose (one-day supply), which can be scaled up according to the production scale.

[0073] Preparation method: The extraction process of white hyacinth bean is the same as that of Poria cocos, and the rest is the same as in Example 1.

[0074] Dosage: Same as in Example 1.

[0075] Effects of use:

[0076] Results: After a trial of 4-8 weeks in 16 patients, 3 patients completed the 8-week intervention (completion rate 18.8%). All enrolled patients were included in the analysis using the carry-over method based on the last observation.

[0077] The average weight decreased by (0.64±1.15) kg, body mass index decreased by (0.27±0.41) kg / m², waist circumference decreased by (0.63±2.20) cm, hip circumference decreased by (0.39±0.75) cm, body fat mass decreased by (0.30±1.10) kg, body fat percentage decreased by (0.65±1.16)%, and visceral fat grade decreased by 0.38±0.81. The decreases in the above indicators were all significantly lower than those in Example 1 (P<0.05), proving that Poria cocos is irreplaceable in this invention.

[0078] Comparative Example 2 (without Polygonatum sibiricum)

[0079] This embodiment is based on Example 1, but with the removal of Polygonatum sibiricum;

[0080] Specifically,

[0081] Formula: 54 parts of Euryale ferox, 40 parts of Coix lacryma-jobi, 100 parts of Poria cocos, 15 parts of Gardenia jasminoides, and 3 parts of Ginseng. The above is the formula for one dose (one-day supply), which can be scaled up according to the production scale.

[0082] Preparation method: Same as in Example 1

[0083] Dosage: Same as in Example 1.

[0084] Effects of use:

[0085] Results: The trial was conducted on 14 patients for 4-8 weeks, of whom 3 completed the 8-week intervention (completion rate 21.4%). All enrolled patients were included in the analysis using the carry-over method based on the last observation.

[0086] The average weight loss was (0.69±1.41) kg, body mass index decreased by (0.1±0.99) kg / m², waist circumference decreased by (1.49±3.24) cm, hip circumference decreased by (0.02±1.38) cm, body fat mass decreased by (0.24±1.99) kg, body fat percentage decreased by (0.01±2.91)%, and visceral fat grade decreased by 0.21±1.48, all significantly lower than in Example 1 (P<0.05). Some patients reported significant dry mouth and fatigue. This demonstrates that Polygonatum rhizome plays an indispensable role in this formula.

[0087] Comparative Example 3 (Comparative observation with a simple diet-based weight loss program)

[0088] To further verify the synergistic effect of the herbal composition of this invention in a dietary weight loss program, overweight and obese patients with spleen deficiency and damp-heat syndrome in the outpatient clinic were divided into two groups according to their wishes:

[0089] Experimental group: 61 cases received the "5+2 intermittent fasting" regimen plus the traditional Chinese medicine of this invention (formula from Example 1);

[0090] Control group: 24 cases who only received the "5+2 intermittent fasting" regimen and did not take traditional Chinese medicine.

[0091] The data in Example 1 and Comparative Example 3 were relatively complete, so a complete case analysis was adopted, including only the data of patients who completed all follow-ups, and no missing values ​​were carried forward.

[0092] (1) Baseline comparability analysis before treatment

[0093] The baseline data of the two groups of patients before treatment are shown in Table 1. There were no significant differences between the two groups in terms of gender, age, weight, BMI, and body fat percentage (P>0.05), and they were comparable.

[0094] Table 1 Comparison of baseline data between the two groups of patients before treatment

[0095] (2) Comparison of changes after intervention

[0096] Two intervention groups underwent 8 weeks of treatment. Changes in weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio, and body composition analysis (body fat mass, body fat percentage, and visceral fat grade) were observed before and after treatment. Table 2 shows the comparison results between 2 weeks and before treatment; Table 3 shows the comparison results between 4 weeks and before treatment; Table 4 shows the comparison results between 6 weeks and before treatment; and Table 5 shows the comparison results between 8 weeks and before treatment. Table 6 shows the comparison of satiety and fatigue levels between the two groups during the intervention process.

[0097] Table 2 Comparison of efficacy between the two groups after 2 weeks of treatment

[0098] Table 3 Comparison of efficacy between the two groups after 4 weeks of treatment.

[0099] Table 4 Comparison of efficacy between the two groups after 6 weeks of treatment.

[0100] Table 5 Comparison of efficacy between the two groups after 8 weeks of treatment.

[0101] Table 6 Comparison of satiety / fatigue levels between the two groups

[0102] After 8 weeks of intervention, the control group (simple 5+2 intermittent fasting) experienced an average weight loss of (1.30±2.22) kg, but an increase in body fat mass of (0.03±2.56) kg and a body fat percentage of (0.69±2.24)%. This indicates that in a real-world clinical setting, while the 5+2 intermittent fasting program relying solely on dietary education can lead to some weight loss, its effect is limited, and the improvement in body composition is not ideal, even resulting in an increase in body fat mass and body fat percentage. In contrast, the experimental group, using the same 5+2 intermittent fasting program in conjunction with the traditional Chinese medicine of this invention (Example 1), experienced a weight loss of (5.79±2.84) kg, a decrease in body fat mass of (4.13±2.11) kg, and a decrease in body fat percentage of (2.50±1.53)%. Compared to the control group, the Example 1 group showed significantly better results in terms of changes in weight, body fat mass, and body fat percentage (P<0.01).

[0103] Conclusion: Under the same "5+2 intermittent fasting" regimen, patients taking the herbal medicine of this invention not only showed significantly better weight loss results than the simple fasting group (P<0.05), but also exhibited significant effects in improving body composition: body fat mass, body fat percentage, and visceral fat grade all decreased significantly, achieving healthy weight loss and fat reduction. Simultaneously, patients experienced stronger satiety, less fatigue, and higher compliance.

[0104] Although the herbal composition of this invention is concise, its target is clearly defined—it can both synergistically enhance weight loss through the 5+2 intermittent fasting method and independently improve body composition, compensating for the shortcomings of simple fasting, which can easily lead to muscle loss and an increase in body fat mass and percentage. Furthermore, it provides a stronger feeling of satiety and less fatigue. This demonstrates that the herbal composition of this invention has a synergistic effect with the "5+2 intermittent fasting" program, making it an ideal meal replacement supplement.

[0105] (3) Verification of compatibility and synergistic effect (disassembled formula comparison)

[0106] To further demonstrate the scientific validity and inventiveness of the formula, the inventors conducted a controlled trial involving the splitting of the formula. Patients in each group received intervention under a "5+2 intermittent fasting" regimen for 8 weeks. Intention-to-be-adjusted analysis was performed using the carry-over method. The number of enrolled patients, completion rate, and weight loss results for each group are as follows.

[0107]

[0108] Improvement in satiety and fatigue:

[0109] In Example 2, patients reported feeling energetic and experiencing minimal fatigue on fasting days. In Example 3, patients with significant damp-heat symptoms reported improved dry mouth, bitter taste, and sticky stools, along with a good feeling of fullness. In Comparative Example 1, patients reported moderate satiety and minimal improvement in sticky stools. In Comparative Example 2, patients reported more pronounced dry mouth and fatigue. The proportion of patients completing the 8-week intervention in Comparative Examples 1 and 2 was significantly lower than in Examples 1-3, mainly because participants withdrew due to perceived insignificant weight loss.

[0110] Conclusion: The herbal composition of this invention (Example 1) is significantly effective in reducing weight and improving body composition (body fat percentage, body fat mass, and visceral fat grade), achieving healthy weight loss and fat reduction. Examples 2 and 3 show lower weight and body fat mass than Example 1 (P < 0.05), but are comparable in improving body composition (body fat percentage, body fat mass, and visceral fat grade) (P > 0.05), and are superior in alleviating fatigue and damp-heat symptoms, respectively. This indicates that the formulation range has a certain degree of flexibility, and increasing the dosage of ginseng or gardenia does not reduce the overall weight loss effect. The weight loss effect of Comparative Examples 1 and 2 is significantly lower than that of Example 1 (P < 0.05), with poor satiety, significant fatigue, and significantly worsened body composition indicators. This proves that Poria cocos and Polygonatum sibiricum are irreplaceable, reflecting the specificity and scientific compatibility of the selected herbs in this invention. In summary, although the formulation of this invention is concise, it is clearly targeted and can work synergistically with the 5+2 intermittent fasting program to achieve effective weight loss and significantly improve body composition, possessing outstanding clinical practical value.

[0111] Safety assessment

[0112] All raw materials used in this invention are highly safe and suitable for long-term use. In all clinical observations (including Examples 1-3 and comparative examples), no significant abnormal effects were found on liver and kidney function, blood routine tests, or other indicators. No serious adverse reactions were reported. In Example 3, among the 12 patients, 2 experienced mild abdominal distension, which resolved spontaneously and did not affect treatment. This phenomenon was not observed in Examples 1-2 and the comparative examples. Analysis suggests that because gardenia is bitter and cold in nature, increased dosage may cause mild gastrointestinal discomfort in some individuals with spleen and stomach deficiency, but overall, the tolerance was good.

[0113] In the description of this specification, references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0114] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific implementations described. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention.

Claims

1. A traditional Chinese medicine composition for obese and overweight individuals with spleen deficiency and damp-heat type, characterized in that, It is made from the following raw materials in parts by weight: 40-60 parts of Euryale ferox, 30-50 parts of Coix lacryma-jobi, 80-110 parts of Poria cocos, 10-20 parts of Gardenia jasminoides, 1-5 parts of Ginseng, and 5-10 parts of Polygonatum sibiricum.

2. The traditional Chinese medicine composition according to claim 1 for obese and overweight individuals with spleen deficiency and damp-heat type, characterized in that, It is made from the following raw materials in parts by weight: 45-55 parts of Euryale ferox, 35-45 parts of Coix lacryma-jobi, 85-105 parts of Poria cocos, 12-18 parts of Gardenia jasminoides, 2-4 parts of Ginseng, and 6-9 parts of Polygonatum sibiricum.

3. The traditional Chinese medicine composition for obese and overweight individuals with spleen deficiency and damp-heat type according to claim 2, characterized in that, It is made from the following raw materials in parts by weight: 54 parts of Euryale ferox, 40 parts of Coix lacryma-jobi, 100 parts of Poria cocos, 15 parts of Gardenia jasminoides, 3 parts of Ginseng, and 6 parts of Polygonatum sibiricum.

4. The traditional Chinese medicine composition according to claim 1 for obese and overweight individuals with spleen deficiency and damp-heat type, characterized in that, The Polygonatum sibiricum is obtained by the following processing method: Take clean Polygonatum sibiricum, add 20 kg of rice wine for every 100 kg of Polygonatum sibiricum, mix well, let it soak until the wine is absorbed, steam until thoroughly cooked, take it out, cut it into thick slices, and dry it. The gardenia fruit was obtained through the following processing method: Take cleaned gardenia fruits and stir-fry them over low heat until the surface turns golden yellow; The Job's tears are prepared by the following method: take wheat bran and heat it until it smokes, add clean Job's tears, the mass ratio of Job's tears to wheat bran is 100:15, stir-fry until the surface is slightly yellow; The fox nuts are prepared by the following method: heat wheat bran until it smokes, add clean fox nuts, the mass ratio of fox nuts to wheat bran is 100:10-15, stir-fry until the surface is slightly yellow.

5. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, Includes the following steps: S1: Weigh out the processed Euryale ferox, Coix lacryma-jobi, Poria cocos, Gardenia jasminoides, Ginseng, and Polygonatum sibiricum according to their respective weight parts; S2: Each herb is decocted separately with water, with the amount of water added each time being 6-24 times the amount of the herb. The extraction time is 0.5-3.5 hours, and the extraction is repeated 1-2 times. The decoction is decocted under normal pressure, and the decoctions of each herb are combined and filtered. S3: The filtrates of each medicinal material are concentrated under reduced pressure at a temperature of 50-90℃ until the relative density is 1.00-1.40, thus obtaining the extracts of each medicinal material. S4: Add each extract to the excipients separately, granulate by dry method, sieve and granulate, collect particles between 16-40 mesh, dry to moisture content ≤5.0%, and obtain dried granules of each medicinal material. S5: Weigh the dried granules of each medicinal material according to the formula ratio, mix them evenly, and you will get the Chinese medicine composition granules.

6. The preparation method according to claim 5, characterized in that, The filtration described in S2 uses a single or double filtration method, with a filter mesh size of 60-300 mesh.

7. The preparation method according to claim 5, characterized in that, The excipients mentioned in S4 include maltodextrin and silicon dioxide.

8. The preparation method according to claim 5, characterized in that, The mixing time described in S5 is 15-60 minutes, until the color is uniform and there are no spots.

9. The traditional Chinese medicine composition according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is granules, capsules, tablets, oral liquids, or pills.

Images