A liposome curcumin composition for weight loss and its use

Abstract

The application discloses a liposome curcumin composition for weight loss and application thereof, and belongs to the technical field of functional food and health food. The core active component of the composition comprises food-grade phospholipid liposome curcumin with a particle size of 60-80 nm and an encapsulation efficiency of greater than or equal to 80%, prebiotics, and pure water extraction dry powder of cardamom, and is further compounded with at least one of mulberry leaf extract, white kidney bean extract and green tea extract. The liposome curcumin is efficiently absorbed, and can target improvement of body metabolic inflammation and reduction of fat accumulation; the green tea extract can accelerate fat oxidation and decomposition; the prebiotics and the cardamom extract can synergistically regulate intestinal flora and improve basal metabolism, so that multi-dimensional long-acting weight loss and fat reduction are realized, and rebound is not easy. All the food-grade natural raw materials are used in the application, there is no organic solvent residue in the whole process, the safety is high, long-term consumption is suitable, the production process is mature and mass production is possible, the application can be widely applied to the field of weight loss, lipid regulation, sugar control, functional food and health food, and has a wide industrialization prospect.

Description

Technical Field

[0001] This invention belongs to the field of functional food and health food technology, and specifically relates to a liposomal curcumin composition for weight loss and its application. Background Technology

[0002] Obesity is a prevalent chronic metabolic disease worldwide, with its prevalence increasing year by year and affecting younger people. Obesity is not simply being overweight; its core pathological mechanism is a long-term imbalance in energy metabolism, where energy intake exceeds energy expenditure. This leads to a series of pathological changes, including abnormal proliferation and differentiation of adipocytes, excessive accumulation of adipose tissue, dysbiosis of the gut microbiota, and chronic low-grade inflammation. Consequently, it can induce various complications such as type 2 diabetes, hyperlipidemia, non-alcoholic fatty liver disease, hypertension, and cardiovascular disease, seriously endangering physical and mental health and creating a huge social and medical burden.

[0003] Currently, weight loss products on the market are mainly divided into three categories: chemical drugs, biological agents, and natural plant extracts. All types of products have significant technical defects and application limitations, and cannot simultaneously guarantee safety, weight loss effect, and long-term stability.

[0004] Existing natural plant-based weight-loss products are mostly single-ingredient formulations, such as L-carnitine, common curcumin, white kidney bean extract, and green tea extract. These products suffer from problems such as limited target action, weak weight-loss effects, and slow onset of action. Curcumin, a natural polyphenol extracted from the rhizome of turmeric, possesses multiple biological activities, including inhibiting adipocyte proliferation, promoting fat decomposition and metabolism, clearing inflammatory factors, and improving lipid metabolism disorders, making it an ideal natural active ingredient for weight loss. However, natural curcumin suffers from extremely poor water solubility, low in vitro stability, easy degradation by gastric acid after oral administration, and extremely low intestinal absorption and utilization; the oral bioavailability of conventional formulations is less than 1%. Existing curcumin formulations prepared using common nano-encapsulation and cyclodextrin encapsulation technologies have excessively strong hydrophilicity, poor biocompatibility with intestinal epithelial cells, and low intracellular delivery efficiency, failing to effectively address the absorption bottleneck of curcumin and greatly limiting its industrial application in the weight-loss field.

[0005] Liposomes are biomimetic nanocarriers constructed based on phospholipid bilayers, possessing both hydrophilic and hydrophobic properties. They can stably encapsulate lipid-soluble and water-soluble active ingredients, exhibiting excellent biocompatibility, non-toxicity, and non-irritation. They can achieve targeted intracellular delivery of active ingredients by fusing with intestinal cell membranes, significantly improving the oral bioavailability of active ingredients. However, existing liposome technology, when applied to curcumin encapsulation, generally suffers from problems such as uneven particle size, low encapsulation efficiency, easy structural disintegration in the acidic environment of the stomach, and insufficient intestinal targeted drug release performance, making it difficult to meet the practical application needs of weight-loss products. For example, existing liposomal curcumin particles are mostly above 100 nm, resulting in low intestinal mucosal penetration efficiency; the encapsulation efficiency is generally below 70%, and a large amount of free curcumin is easily degraded by gastric acid; lacking pH-responsive characteristics, it cannot stably and sustainably release in gastric juice or accurately release in intestinal juice, leading to unsatisfactory utilization of active ingredients. Furthermore, existing weight-loss compositions mostly use a single active ingredient, failing to form a multi-target synergistic mechanism. This prevents them from achieving a complete weight-loss system that controls intake, boosts metabolism, inhibits fat accumulation, reduces inflammation, and regulates gut microbiota, resulting in limited weight-loss effects and a high risk of rebound. Additionally, some products use organic solvent extraction processes to prepare raw materials, posing a risk of solvent residue and insufficient raw material compliance, making it difficult to meet the production requirements for food-grade products.

[0006] Therefore, it is necessary to develop a liposomal curcumin weight loss composition that has a multi-target synergistic effect, is safe and has no side effects, can be consumed for a long time, and is suitable for large-scale production, so as to overcome many defects of existing technologies and achieve multiple effects such as efficient weight loss, reduction of body fat, reduction of visceral fat, and regulation of postprandial blood sugar. Summary of the Invention

[0007] In view of this, the present invention provides a liposomal curcumin composition for weight loss and its application therein, in order to solve or alleviate one of the technical problems existing in the prior art, and at least provide a beneficial alternative.

[0008] The technical solution of this invention is implemented as follows: a composition for weight loss, wherein the core active components of the composition include food-grade phospholipid liposome curcumin with a particle size of 60-80nm, prebiotics and cardamom purified water extract powder, and compounded with at least one of mulberry leaf extract, white kidney bean extract and green tea extract. The encapsulation efficiency of the liposomal curcumin is ≥80%; The raw materials for preparing the liposomal curcumin include curcumin, food-grade phospholipids, and glycerol; The preparation method is as follows: curcumin, food-grade phospholipids and glycerol are dissolved in anhydrous ethanol, and the ethanol is removed by rotary evaporation in a constant temperature water bath at 40°C to form a uniform film. Purified water is added to hydrate the film, and then the particle size is adjusted to 60~80nm by high pressure homogenization. The ethanol residue of the resulting liposome curcumin suspension is ≤0.5‰. The cardamom purified water powder is obtained by extracting cardamom (Elettaria cardamomum) with purified water through reflux extraction, filtration, concentration, and spray drying, without the addition of any organic solvents throughout the process; Based on a single dose, the liposomal curcumin content is 10-100 mg, the prebiotic content is 200-1000 mg, the cardamom water-extracted powder content is 10-60 mg, the mulberry leaf extract content is 10-50 mg, the white kidney bean extract content is 500-1000 mg, and the green tea extract content is 100-300 mg.

[0009] Preferably, the phospholipids used to prepare the liposome curcumin are selected from one or more food-grade raw materials selected from soybean lecithin, sunflower lecithin, and egg yolk lecithin. The liposomal curcumin exhibits pH-responsive characteristics of sustained gastric release and targeted intestinal release, specifically showing a cumulative release rate of ≤30% over 2 hours in simulated gastric fluid at pH=2.0 and a cumulative release rate of ≥80% over 2 hours in simulated intestinal fluid at pH=7.4. The food-grade phospholipids constitute 3 to 5 times the mass of curcumin in liposomal curcumin.

[0010] Preferably, the prebiotic is selected from one or more of inulin, fructooligosaccharides, galactooligosaccharides, and xylooligosaccharides, with inulin being preferred; The inulin is food grade, with a degree of polymerization ≥10 and a fructooligosaccharide content ≥90%; the prebiotics in the composition are used to regulate the balance of intestinal flora, repair the intestinal barrier, and improve metabolic disorders.

[0011] Preferably, the preparation process of the cardamom water-extracted powder is as follows: Crush the cardamom raw material, add 8 to 10 times its weight of purified water, and extract by reflux at 75 to 85°C for 2 to 3 times, with each extraction lasting 1 to 2 hours. The combined extracts were filtered to remove impurities, concentrated under reduced pressure to a solid content of 35% to 45%, and spray-dried to obtain cardamom pure water extract powder. The cardamom water-extracted powder contains 10-15 mg / g of characteristic components, ≤5% moisture content, ≤5% ash content, and no organic solvent residue.

[0012] Preferably, the mulberry leaf extract contains ≥1% 1-deoxynojirimycin (DNJ) and is prepared by water extraction and alcohol precipitation. The specific process is as follows: After pulverizing mulberry leaves, add water and decoct 2-3 times. Combine the decoctions, filter, concentrate the filtrate to a relative density of 1.10-1.15 (60℃), add ethanol to a content of 60%-70%, let stand to precipitate, take the supernatant to recover the ethanol, concentrate and dry to obtain the product. The mulberry leaf extract, in combination with white kidney bean extract, synergistically blocks the breakdown and absorption of carbohydrates, reduces calorie intake, and stabilizes postprandial blood sugar.

[0013] Preferably, the white kidney bean extract has an α-amylase inhibitory activity ≥3000 IU / g and is prepared by ethanol extraction combined with macroporous resin purification. The specific process is as follows: After defatting, white kidney beans are crushed and extracted with 60%~70% ethanol solution 2~3 times. The extracts are combined, concentrated under reduced pressure, and then loaded onto a macroporous adsorption resin column. The extracts are eluted sequentially with water and 30%~50% ethanol. The eluent is collected, concentrated, and dried to obtain the final product. The white kidney bean extract in the composition inhibits α-amylase activity, blocking the breakdown of starch into glucose and reducing carbohydrate absorption.

[0014] Preferably, the green tea extract contains ≥50% epigallocatechin gallate (EGCG) and is prepared using a hot water extraction combined with solvent extraction method. The specific process is as follows: Green tea is pulverized and extracted with hot water at 70-80℃ 2-3 times. The extracts are combined, concentrated, extracted with ethyl acetate, the ethyl acetate is recovered, and then dried under vacuum to obtain the product. The green tea extract in the composition reduces fat accumulation by accelerating fat oxidation and decomposition and inhibiting the activity of fat synthesis enzymes.

[0015] Preferably, the composition further comprises a food-acceptable excipient selected from one or more of preservatives, acidulants, sweeteners, solubilizers, and stabilizers, wherein the preservative is preferably potassium sorbate, the acidulant is preferably citric acid, the sweetener is preferably sucralose, the solubilizer is preferably polysorbate-80, and the stabilizer is preferably xanthan gum. The dosage form of the composition is any one of oral liquid, tablet, capsule, granule or powder, preferably 30ml oral liquid; the oral liquid has a pH of 4.0~4.5 and a viscosity of 1.2~1.5mPa·s (25℃).

[0016] Preferably, the sterilization process of the oral liquid dosage form adopts either high-temperature sterilization at 121°C for 15 minutes or aseptic filtration at room temperature using a 0.22μm filter membrane. The specific parameters of the 121℃ high-temperature sterilization process are: sterilization temperature 121℃, sterilization time 15min, and filling after cooling to room temperature. The specific parameters of the 0.22μm filter membrane room temperature aseptic filtration process are as follows: Under cleanliness level 100 conditions, a mixed cellulose ester filter membrane with a pore size of 0.22 μm was used for filtration, and the filtrate was directly filled into sterile oral liquid bottles and sealed. Both sterilization processes ensure that the microbiological indicators of the oral liquid meet the requirements of the GB 4789 series of food standards, and that the retention rate of active ingredients is ≥90%.

[0017] Preferably, the food or health food is taken on an empty stomach before meals every day, with a single dose calculated as a single unit, and the continuous use period is not less than 4 weeks. The food or health food products used in this application are suitable for overweight individuals with a BMI ≥ 24 and obese individuals with a BMI ≥ 28. Long-term use is free from adverse reactions such as diarrhea, nausea, vomiting, insomnia, and palpitations. The weight rebound rate after discontinuation of the medication is ≤ 10% (6-month follow-up data).

[0018] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: First, this invention precisely controls the particle size of liposomal curcumin to 60-80 nm with an encapsulation rate of ≥80%, using a food-grade biomimetic phospholipid carrier, resulting in extremely low solvent residue in the finished product. This liposome structure possesses unique pH-responsive characteristics, allowing it to remain stable and slowly release curcumin in acidic gastric juice, preventing degradation by gastric acid. Upon entering the neutral intestinal tract, it rapidly targets and releases the drug, efficiently fusing with intestinal epithelial cells. Compared to ordinary curcumin and conventionally encapsulated curcumin, oral absorption and utilization are increased several times, fundamentally solving the industry pain points of poor absorption and weak efficacy of natural curcumin. Experimental data shows that the cumulative release rate of the liposomal curcumin of this invention is only 27% in simulated gastric juice at pH 2.0, while reaching 86% in simulated intestinal juice at pH 7.4. In contrast, the release rate of ordinary nano-curcumin in gastric juice is 58% and intestinal juice is only 72% in 2 hours, demonstrating that the gastric acid stability and intestinal targeted drug release performance of the liposomes of this invention are significantly superior to existing technologies.

[0019] Secondly, this invention constructs five complementary and synergistic fat-reducing pathways, forming a complete fat-reducing system: liposomal curcumin targets and clears chronic inflammation, inhibits adipocyte proliferation, and promotes lipid metabolism; prebiotics precisely regulate the balance of intestinal flora, repair the intestinal barrier, and fundamentally improve metabolic disorders, achieving long-term weight control; cardamom water extract effectively increases the body's basal metabolic rate and accelerates calorie consumption; white kidney bean extract and mulberry leaf extract dually block the decomposition and absorption of carbohydrates, reducing calorie intake and stabilizing postprandial blood sugar; green tea EGCG accelerates fat oxidation and decomposition, reducing fat accumulation. The synergistic effect of multiple components, taking into account intake control, metabolism enhancement, fat inhibition, inflammation reduction, and flora regulation, results in a fat-reducing effect far superior to single-component products, and the improved metabolic mechanism makes weight rebound less likely. Animal experiments show that after 4 weeks of continuous administration, the weight of mice in the composition group of this invention decreased by 24.6% compared to the model group, the wet weight of epididymal fat decreased by 38.2%, serum total cholesterol, triglycerides, and low-density lipoprotein levels significantly decreased, and high-density lipoprotein levels significantly increased, with significantly better effects than the single-component or non-liposomal encapsulated control groups.

[0020] Third, all raw materials used in this invention are food-grade natural plant materials and food-grade phospholipid excipients, free of chemically synthesized additives, hormones, and prohibited weight-loss ingredients. Cardamom is extracted using a pure water extraction process, leaving no organic solvent residue, thus avoiding the risks associated with new food ingredient registration. The raw materials are compliant, non-toxic, and have no side effects, making them suitable for long-term daily consumption by various overweight and obese individuals, overcoming the drawbacks of chemical weight-loss products and biological agents with significant side effects. Human trials show that subjects who took the composition of this invention for 12 consecutive weeks experienced an average weight loss of 6.9±1.4 kg, a waist circumference reduction of 7.5±1.7 cm, an average decrease in body fat percentage of 4.5±1.1%, and a significant reduction in postprandial blood glucose fluctuations. No adverse reactions such as diarrhea, nausea, vomiting, insomnia, or palpitations were observed, fully validating its safety.

[0021] Fourth, the preparation process of this invention is simple, mild, and highly controllable. Both the sterilization and molding processes are suitable for large-scale industrial production. The preferred oral liquid dosage form is portable, easy to take, and has a wide target audience, making it widely applicable in the research and development and production of functional foods and health foods, with extremely high market value. For example, the oral liquid can be sterilized at 121℃ for 15 minutes or aseptically filtered at room temperature using a 0.22μm filter membrane, ensuring both sterilization effectiveness and preventing the inactivation of active ingredients, suitable for the needs of different production scenarios.

[0022] The above overview is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features of the invention will become readily apparent from the accompanying drawings and the following detailed description. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a flowchart illustrating the preparation process of the liposomal curcumin of the present invention. Figure 2 This is a process flow diagram for preparing the cardamom purified water powder of the present invention; Figure 3 This is a process flow diagram for preparing the weight-loss composition oral liquid of the present invention; Figure 4 This is a flowchart illustrating the synergistic mechanism of the five fat-reducing pathways in this invention. Detailed Implementation

[0025] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0026] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0027] Preparation Example 1: Preparation of Liposome Curcumin

[0028] Take 5g of curcumin, 18g of food-grade soybean lecithin, and 5g of glycerol by weight, dissolve them together in an appropriate amount of anhydrous ethanol, and remove the ethanol by rotary evaporation in a 40℃ constant temperature water bath to form a uniform film. Add 200ml of purified water for film hydration treatment. After hydration, homogenize using a high-pressure homogenizer, precisely controlling the particle size to 60-80nm to obtain a homogeneous and stable liposome curcumin suspension. The finished product showed ethanol residue ≤0.5‰ and encapsulation efficiency ≥90%.

[0029] Table 1. Results of key parameter detection for liposome curcumin in Preparation Example 1

[0030] Preparation Example 2: Preparation of Cardamom Water Extract Powder

[0031] The cardamom raw material was crushed, and 9 times its weight of purified water was added. The mixture was extracted twice under pure water reflux at 80°C, with each extraction lasting 1.5 hours. The two extraction filtrates were combined, filtered to remove residues and impurities, and concentrated under reduced pressure to a solid content of 40%. Cardamom pure water extract powder was obtained by spray drying and sealed for later use. No organic solvents were added throughout the process.

[0032] Table 2. Quality test results of cardamom pure water extract powder from Preparation Example 2.

[0033] Example 1 (Preferred Formula)

[0034] The liposomal curcumin suspension prepared in Preparation Example 1, inulin, cardamom water extract powder prepared in Preparation Example 2, mulberry leaf extract (DNJ content ≥1%), white kidney bean extract (α-amylase inhibitory activity ≥3000 IU / g), and green tea extract (EGCG content ≥50%) were mixed evenly in proportion. Food-grade conventional excipients (including potassium sorbate 0.1g / 100ml, citric acid 0.2g / 100ml to adjust pH to 4.0-4.5, and purified water to 30ml) were added to adjust the stability of the system. The mixture was then filled into 30ml / bottle oral liquid and sterilized using a high-temperature sterilization process at 121℃ for 15min.

[0035] Each 30ml bottle of oral liquid contains the following active ingredients: liposomal curcumin 50mg (calculated as curcumin), inulin 500mg, cardamom water extract 30mg, mulberry leaf extract 30mg, white kidney bean extract 700mg, and green tea extract with EGCG ≥ 50% 200mg.

[0036] Table 3. Composition of the oral liquid formulation in Example 1

[0037] Table 4. Results of Physicochemical Indicators Detection for Oral Liquid in Example 1

[0038] Table 5. Stability test data of oral liquid in Example 1 (accelerated test, 40℃±2℃, RH75%±5%, 3 months)

[0039] Example 2 (High-efficiency formulation)

[0040] The overall formula, preparation process, and sterilization process are the same as in Example 1. The difference is that the content of green tea extract is increased to 300mg / bottle and the content of white kidney bean extract is increased to 800mg / bottle to enhance the effects of carbohydrate blocking and fat decomposition.

[0041] Table 6. Composition of the oral liquid formulation in Example 2

[0042] Table 7 Comparison of fat reduction effects between the oral liquid of Example 2 and Example 1 (Animal experiment, n=10, 4 weeks)

[0043] Table 8. Serum lipid index detection results of oral liquid in Example 2 (n=10, 4 weeks)

[0044] Example 3 (Economic Core Formula)

[0045] The overall formula, preparation process, and sterilization process are the same as in Example 1. The difference is that the liposomal curcumin is replaced with an equal amount of ordinary inulin to encapsulate nano-curcumin (particle size 60-80nm, encapsulation rate ≥80%, but no pH response characteristics), while the content of other components and preparation parameters remain unchanged.

[0046] Table 9. Composition of Oral Liquid Formulation in Example 3

[0047] Table 10 Comparison of in vitro release rates between Example 3 and Example 1 (dialysis bag method, n=3)

[0048] Table 11 Comparison of fat loss effects in animals between Example 3 and Example 1 (n=10, 4 weeks)

[0049] Table 12 Preliminary results of human trials of the oral liquid in Example 3 (n=10, 4 weeks)

[0050] Comparative Example 1 (Control Group without Liposome Encapsulation)

[0051] The formula and preparation process are completely consistent with those in Example 1, except that the liposomal curcumin is replaced with an equal amount of ordinary curcumin raw material that has not been encapsulated.

[0052] Table 13 Comparison of in vitro release rates between Comparative Example 1 and Example 1 (dialysis bag method, n=3)

[0053] Table 14 Comparison of fat loss effects in animals between Comparative Example 1 and Example 1 (n=10, 4 weeks)

[0054] Comparative Example 2 (Control Group without Cardamom Component)

[0055] The formula and preparation process are completely the same as in Example 1, except that the cardamom water-extracted dry powder component in the formula is removed, while the other raw materials and their contents remain unchanged.

[0056] Table 15 Comparison of fat loss effects in animals between Comparative Example 2 and Example 1 (n=10, 4 weeks)

[0057] Comparative Example 3 (Single-component control group)

[0058] Using only the single active ingredient liposomal curcumin prepared according to this invention, without other components such as prebiotics, cardamom water extract powder, or plant extracts, it is prepared into an oral liquid dosage form of the same concentration (each 30ml bottle contains 50mg of liposomal curcumin).

[0059] Table 16 Comparison of fat loss effects in animals between Comparative Example 3 and Example 1 (n=10, 4 weeks)

[0060] Experimental Example 1: Detection of Liposome Particle Size and Encapsulation Efficiency

[0061] The particle size of the liposomal curcumin prepared in Example 1 was determined using a dynamic light scattering particle size analyzer. The results showed that the average particle size of the liposomal curcumin was 68.4 ± 3.2 nm, precisely falling within the preferred range of 60-80 nm (corresponding to...). Figure 1 The encapsulation efficiency was determined using the dextran gel column method, and the encapsulation efficiency was 91.7±2.3%, which is much higher than the ≥80% standard specified in this invention, indicating excellent encapsulation stability of the system.

[0062] Table 17 Results of particle size and encapsulation efficiency of liposome curcumin from different batches (n=5)

[0063] Experimental Example 2: In vitro simulated release rate detection

[0064] The in vitro cumulative release performance of liposomal curcumin (Example 1) and conventional nano-curcumin (Comparative Example 1) was tested using a dialysis bag method to simulate human gastric juice (pH=2.0) and intestinal juice (pH=7.4). The results showed that the liposomal curcumin of this invention had a cumulative release rate of only 27% in simulated gastric juice at pH 2.0 after 2 hours, demonstrating strong resistance to gastric acid degradation; and a cumulative release rate of 86% in simulated intestinal juice at pH 7.4 after 2 hours, enabling rapid targeted drug release into the intestine. In contrast, the conventional nano-curcumin of Comparative Example 1 had a release rate of 58% in gastric juice and 72% in intestinal juice after 2 hours, exhibiting poor gastric acid stability and low intestinal drug release efficiency (corresponding to...). Figure 2 This demonstrates that the liposome carrier structure defined in this invention possesses excellent pH-responsive sustained-release and targeted drug release properties, effectively protecting curcumin from gastric acid degradation and improving intestinal absorption efficiency.

[0065] Table 18. Kinetic parameters of liposome and conventional curcumin release under different pH conditions (n=3)

[0066] Experiment Example 3: Animal Fat Reduction Effect Verification Experiment

[0067] A high-fat diet was used to induce an obese mouse model. The successfully modeled obese mice were randomly divided into a model group, Example 1-3 groups, and Comparative Example 1-3 groups, with 10 mice in each group. The mice were administered the drug by gavage for 4 consecutive weeks. They were kept in a normal environment with free access to food and water. The weight of the mice was recorded daily. After the experiment, the mice were dissected and the wet weight of epididymal fat and serum lipid levels were measured.

[0068] Experimental results show (corresponding) Figure 3 , Figure 4After 4 weeks of continuous administration, the body weight of mice in Example 1 group decreased by 24.6% compared with the blank model group, the wet weight of epididymal fat decreased by 38.2%, and the levels of serum total cholesterol, triglycerides, and low-density lipoprotein decreased significantly, while the level of high-density lipoprotein increased significantly. Its fat reduction and lipid regulation effects were significantly better than those of Examples 2, 3, and each comparative group (P<0.05). The fat reduction effects of Comparative Groups 1 and 3 were weak, demonstrating that liposome encapsulation technology and the synergistic combination of multiple components are the core key to achieving efficient fat reduction in this invention. The effect of Comparative Group 2 was significantly reduced, demonstrating that the cardamom component can effectively synergistically enhance and improve the fat reduction effect.

[0069] Table 19 Dynamic data on body weight changes in mice of each group (n=10, unit: g)

[0070] Table 20. Epididymal fat wet weight and organ coefficients of mice in each group (n=10)

[0071] Table 21 Results of serum lipid levels in mice in each group (n=10)

[0072] Experiment Example 4: Safety and Efficacy Experiment in Human Trials

[0073] Twenty overweight healthy subjects with a BMI of 25-30 were selected. They had no basic metabolic diseases and no history of drug allergies. They took one bottle of the oral liquid sample prepared in Example 1 twice a day on an empty stomach before meals for 12 weeks. During the experiment, they maintained normal diet and rest, and did not deliberately diet or engage in high-intensity exercise.

[0074] The trial results showed that after 12 weeks of intervention, participants lost an average of 6.9±1.4 kg, their waist circumference decreased by 7.5±1.7 cm, their body fat percentage decreased by an average of 4.5±1.1%, postprandial blood glucose fluctuations were significantly reduced, and pre-meal hunger and binge eating desires were significantly improved. Throughout the entire trial period, no adverse reactions such as diarrhea, nausea, vomiting, insomnia, or palpitations occurred in any of the participants, proving that the composition of this invention is highly safe, has a definite fat-reducing effect, and can be consumed long-term.

[0075] Table 22 Baseline characteristics of subjects in the human food trial (n=20)

[0076] Table 23 Changes in indicators before and after human food trial intervention (n=20)

[0077] Table 24. Adverse reactions in human trials (n=20, 12 weeks)

[0078] Industrial applicability

[0079] The composition of this invention uses all food-grade natural raw materials, with no prohibited chemically synthesized ingredients, no solvent residues, and no toxic side effects. The raw materials are highly compliant and meet national standards for the production of functional foods and health foods. The preparation process of this invention is mild, simple, and parameter-controllable. Sterilization and filling processes are mature and suitable for large-scale, standardized industrial production with controllable production costs. The prepared oral liquid dosage form is portable, palatable, and suitable for a wide range of users. It effectively achieves weight loss, reduces body fat, decreases visceral fat, and regulates postprandial blood sugar. It can be widely used in the research and development and production of various weight-loss functional foods and health foods, possessing extremely high industrial value and broad market application prospects.

[0080] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A composition for weight loss, characterized in that, The core active components of the composition include food-grade phospholipid liposome curcumin, prebiotics and cardamom purified water powder with a particle size of 60-80 nm, and are compounded with at least one of mulberry leaf extract, white kidney bean extract and green tea extract. The encapsulation efficiency of the liposomal curcumin is ≥80%; The raw materials for preparing the liposomal curcumin include curcumin, food-grade phospholipids, and glycerol; The preparation method is as follows: curcumin, food-grade phospholipids and glycerol are dissolved in anhydrous ethanol, and the ethanol is removed by rotary evaporation in a constant temperature water bath at 40°C to form a uniform film. Purified water is added to hydrate the film, and then the particle size is adjusted to 60~80nm by high pressure homogenization. The ethanol residue of the resulting liposome curcumin suspension is ≤0.5‰. The cardamom purified water powder is obtained by extracting cardamom (Elettaria cardamomum) with purified water through reflux extraction, filtration, concentration, and spray drying, without the addition of any organic solvents throughout the process; Based on a single dose, the liposomal curcumin content is 10-100 mg, the prebiotic content is 200-1000 mg, the cardamom water-extracted powder content is 10-60 mg, the mulberry leaf extract content is 10-50 mg, the white kidney bean extract content is 500-1000 mg, and the green tea extract content is 100-300 mg.

2. The composition according to claim 1, characterized in that, The phospholipids used to prepare the liposome curcumin are selected from one or more food-grade raw materials selected from soybean lecithin, sunflower lecithin, and egg yolk lecithin. The liposomal curcumin exhibits pH-responsive characteristics of sustained gastric release and targeted intestinal release, specifically showing a cumulative release rate of ≤30% over 2 hours in simulated gastric fluid at pH=2.0 and a cumulative release rate of ≥80% over 2 hours in simulated intestinal fluid at pH=7.

4. The food-grade phospholipids constitute 3 to 5 times the mass of curcumin in liposomal curcumin.

3. The composition according to claim 1, characterized in that, The prebiotic is selected from one or more of inulin, fructooligosaccharides, galactooligosaccharides, and xylooligosaccharides, with inulin being preferred; The inulin is food grade, with a degree of polymerization ≥10 and a fructooligosaccharide content ≥90%; the prebiotics in the composition are used to regulate the balance of intestinal flora, repair the intestinal barrier, and improve metabolic disorders.

4. The composition according to claim 1, characterized in that, The preparation process of the cardamom water-extracted powder is as follows: Crush the cardamom raw material, add 8 to 10 times its weight of purified water, and extract by reflux at 75 to 85°C for 2 to 3 times, with each extraction lasting 1 to 2 hours. The combined extracts were filtered to remove impurities, concentrated under reduced pressure to a solid content of 35% to 45%, and spray-dried to obtain cardamom pure water extract powder. The cardamom water-extracted powder contains 10-15 mg / g of characteristic components, ≤5% moisture content, ≤5% ash content, and no organic solvent residue.

5. The composition according to claim 1, characterized in that, The mulberry leaf extract contains ≥1% 1-deoxynojirimycin (DNJ) and is prepared by water extraction and alcohol precipitation. The specific process is as follows: After pulverizing mulberry leaves, add water and decoct 2-3 times. Combine the decoctions, filter, concentrate the filtrate to a relative density of 1.10-1.15 (60℃), add ethanol to a content of 60%-70%, let stand to precipitate, take the supernatant to recover the ethanol, concentrate and dry to obtain the product. The mulberry leaf extract, in combination with white kidney bean extract, synergistically blocks the breakdown and absorption of carbohydrates, reduces calorie intake, and stabilizes postprandial blood sugar.

6. The composition according to claim 1, characterized in that, The white kidney bean extract with α-amylase inhibitory activity ≥3000 IU / g was prepared by ethanol extraction combined with macroporous resin purification. The specific process is as follows: After defatting, white kidney beans are crushed and extracted with 60%~70% ethanol solution 2~3 times. The extracts are combined, concentrated under reduced pressure, and then loaded onto a macroporous adsorption resin column. The extracts are eluted sequentially with water and 30%~50% ethanol. The eluent is collected, concentrated, and dried to obtain the final product. The white kidney bean extract in the composition inhibits α-amylase activity, blocking the breakdown of starch into glucose and reducing carbohydrate absorption.

7. The composition according to claim 1, characterized in that, The green tea extract contains ≥50% epigallocatechin gallate (EGCG) and is prepared using a combination of hot water extraction and solvent extraction. The specific process is as follows: Green tea is pulverized and extracted with hot water at 70-80℃ 2-3 times. The extracts are combined, concentrated, extracted with ethyl acetate, the ethyl acetate is recovered, and then dried under vacuum to obtain the product. The green tea extract in the composition reduces fat accumulation by accelerating fat oxidation and decomposition and inhibiting the activity of fat synthesis enzymes.

8. The composition according to claim 1, characterized in that, The composition further comprises food-acceptable excipients selected from one or more of preservatives, acidulants, sweeteners, solubilizers, and stabilizers, wherein potassium sorbate is preferred as a preservative, citric acid is preferred as an acidulant, sucralose is preferred as a sweetener, polysorbate-80 is preferred as a solubilizer, and xanthan gum is preferred as a stabilizer. The dosage form of the composition is any one of oral liquid, tablet, capsule, granule or powder, preferably 30ml oral liquid; the oral liquid has a pH of 4.0~4.5 and a viscosity of 1.2~1.5mPa·s (25℃).

9. The composition according to claim 8, characterized in that, The sterilization process for the oral liquid dosage form is either high-temperature sterilization at 121℃ for 15 minutes or aseptic filtration at room temperature using a 0.22μm filter membrane. The specific parameters of the 121℃ high-temperature sterilization process are: sterilization temperature 121℃, sterilization time 15min, and filling after cooling to room temperature. The specific parameters of the 0.22μm filter membrane room temperature aseptic filtration process are as follows: Under cleanliness level 100 conditions, a mixed cellulose ester filter membrane with a pore size of 0.22 μm was used for filtration, and the filtrate was directly filled into sterile oral liquid bottles and sealed. Both sterilization processes ensure that the microbiological indicators of the oral liquid meet the requirements of the GB 4789 series of food standards, and that the retention rate of active ingredients is ≥90%.

10. The use of the composition according to any one of claims 1 to 9 in the preparation of food or health food having the functions of weight loss, reducing body fat, reducing visceral fat and / or regulating postprandial blood glucose, characterized in that, The food or health food shall be taken on an empty stomach before meals every day. The dosage for a single dose shall be calculated as a single unit, and the continuous use period shall not be less than 4 weeks. The food or health food products used in this application are suitable for overweight individuals with a BMI ≥ 24 and obese individuals with a BMI ≥ 28. Long-term use is free from adverse reactions such as diarrhea, nausea, vomiting, insomnia, and palpitations. The weight rebound rate after discontinuation of the medication is ≤ 10% (6-month follow-up data).

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