Preparation for losing weight and lowering lipid as well as preparation method and application thereof

Abstract

The invention provides a weight-losing and lipid-lowering preparation as well as a preparation method and application thereof, and belongs to the technical field of weight-losing preparations. Comprising the following raw materials in parts by weight: 150-250 parts of cortex phellodendri, 5-15 parts of linoleic acid, 1-5 parts of L-carnitine, 50-90 parts of semen cassiae, 51-89 parts of lotus leaves, 50-80 parts of radix polygoni multiflori preparata, 40-60 parts of haws, 40-60 parts of black sesames, 20-40 parts of licorice roots, 20-40 parts of dark green tea, 5-10 parts of an additive and 20-40 parts of a hydrogel sustained-release material. The composition has the advantages of clearing heat, eliminating dampness, reducing lipid, dissolving turbidity, accelerating fat oxidation, regulating spleen and stomach, reducing energy intake, reducing fat sources, accelerating fat path, improving insulin sensitivity and intestinal environment, being suitable for damp-heat type, phlegm-dampness type and spleen deficiency type obesity people and increasing satiety, and having wide application prospects.

Description

Technical Field

[0001] This invention relates to the field of weight loss formulation technology, specifically to a formulation for weight loss and lipid reduction, its preparation method, and its application. Background Technology

[0002] Over the past few decades, obesity has gradually become a global epidemic, defined as an abnormal or excessive accumulation of fat that can impair health. Obesity is one of the leading causes of metabolic syndrome, characterized by metabolic abnormalities including high blood pressure, high blood sugar, excess abdominal fat, elevated serum triglycerides, and low levels of high-density lipoprotein (HDL). Metabolic syndrome increases the risk of health problems including cardiovascular disease, type 2 diabetes, and stroke.

[0003] Obesity is broadly classified into two categories: simple obesity and secondary obesity. Generally, obesity refers to simple obesity, defined as a weight exceeding the standard weight by more than 20%. Obesity not only affects work, life, and appearance but also poses significant health risks. Obesity is currently the third leading threat to human health after cardiovascular disease and cancer. Obese individuals are prone to hypertension, coronary heart disease, fatty liver, diabetes, hyperlipidemia, gout, and gallstones. Clinical tests reveal that the vast majority of patients with simple obesity exhibit endocrine disorders, particularly hyperinsulinemia, abnormal glucose tolerance tests, sex hormone imbalances, elevated adrenal cortex hormones, and increased leptin levels.

[0004] Currently, there are two main types of weight-loss drugs on the market: pancreatic lipase inhibitors and appetite suppressants that act on the central nervous system. Appetite suppressants are restricted in use due to the potential for adverse neurological reactions. Orlistat, a pancreatic lipase inhibitor, works by inhibiting pancreatic lipase activity, thereby inhibiting the breakdown and absorption of fat from food, thus promoting weight loss. However, it carries safety uncertainties, including the potential for liver damage. Summary of the Invention

[0005] The purpose of this invention is to propose a preparation, preparation method and application for weight loss and lipid reduction. It clears heat and removes dampness, reduces lipids and eliminates turbidity, accelerates fat oxidation, harmonizes the spleen and stomach, and reduces energy intake. It reduces fat sources and accelerates fat elimination. At the same time, it improves insulin sensitivity and intestinal environment. It is suitable for obese people with damp-heat type, phlegm-dampness type and spleen deficiency type, increases satiety and has broad application prospects.

[0006] The technical solution of this invention is implemented as follows: This invention provides a formulation for weight loss and lipid reduction, comprising the following raw materials in parts by weight: 150-250 parts of Phellodendron bark, 5-15 parts of linoleic acid, 1-5 parts of L-carnitine, 50-90 parts of cassia seed, 51-89 parts of lotus leaf, 50-80 parts of processed Polygonum multiflorum, 40-60 parts of hawthorn, 40-60 parts of black sesame, 20-40 parts of licorice, 20-40 parts of black tea, 5-10 parts of additives, and 20-40 parts of hydrogel sustained-release material. The hydrogel sustained-release material is a pH-responsive gastric volume-carrying hydrogel loaded with temperature-sensitive microcapsules. The temperature-sensitive microcapsules contain epigallocatechin gallate / theanine conjugate and exosomes loaded with active extracts.

[0007] As a further improvement of the present invention, the additives include zinc lactate, ferrous lactate, selenium-enriched yeast, thiamine hydrochloride, riboflavin, and pyridoxine hydrochloride in a mass ratio of 1-3:2-5:5-10:1-2:1-2:2-4.

[0008] As a further improvement of the present invention, the preparation method of the hydrogel sustained-release material is as follows: S1. Preparation of milk exosomes: Skim milk was initially centrifuged to obtain the supernatant, then centrifuged deeply until no obvious precipitate was found, concentrated by ultrafiltration, purified by chromatographic column, and freeze-dried to obtain milk exosomes; S2. Preparation of active extract powder: Celery, coffee beans and corn silk are washed, dried and crushed, added to a deep eutectic solvent, and supercritical fluid CO2 is added. Under critical conditions, the mixture is stirred and extracted, the CO2 is released by depressurization, water is added to precipitate, filtered, washed, dried and ball-milled to obtain active extract powder. S3. Loading; The active extract powder and milk exosomes were added to PBS buffer, sonicated on ice, heated and incubated for a longer period, and then freeze-dried to obtain loaded exosomes; S4. Preparation of epigallocatechin gallate / theanine conjugate: Epigallocatechin gallate and theanine were added to n-butanol, p-toluenesulfonic acid was added, the mixture was heated under reflux for extraction, water was added, the mixture was filtered, washed, and dried to obtain the epigallocatechin gallate / theanine conjugate. S5. Preparation of temperature-sensitive microcapsules: Carrageenan was added to water, hydrogen peroxide was added, the mixture was heated and stirred to react, filtered, dialyzed, and dried to obtain oxidized carrageenan. The oxidized carrageenan was added to acid solution and stirred to mix evenly. Epigallocatechin gallate / theanine conjugate, loaded exosomes and emulsifier were added and stirred to mix evenly. Chitosan was added and added dropwise to fish oil. The mixture was emulsified, calcium chloride was added, and the mixture was cured at room temperature. The mixture was filtered, washed, and dried to obtain temperature-sensitive microcapsules. S6. Preparation of oxidized carboxylated chitosan: Carboxylated chitosan was added to water, NaIO4 was dissolved in water under light-protected conditions, and added to the above solution. The reaction was stirred at room temperature under light-protected conditions, the reaction was quenched by adding ethylene glycol, dialyzed, and freeze-dried to obtain oxidized carboxylated chitosan. S7. Preparation of hydrogel sustained-release material: Oxidized carboxylated chitosan and carboxylated cellulose were dissolved in water and mixed evenly. Sodium tetraborate was added, and the mixture was heated and stirred. Then, thermosensitive microcapsules and sodium bicarbonate were added and stirred evenly. The mixture was poured into a mold, allowed to stand at room temperature, and then freeze-dried to obtain the hydrogel sustained-release material.

[0009] As a further improvement of the present invention, the preliminary centrifugation conditions in step S1 are 4°C, 2500-3500g for 10-20min, and the deep centrifugation conditions are 4°C, 11500-12500g. The ultrafiltration concentration uses an ultrafiltration tube of 95-105ku, and the chromatographic column is a qEV original column. In step S2, the mass ratio of celery, coffee beans, and corn silk is 3-5:2-4:1-3, the mass ratio of the eutectic solvent and supercritical fluid CO2 is 100:5-8, the critical conditions are a temperature of 31-35°C and a pressure of 7.4-7.8 MPa, the pressure is reduced to atmospheric pressure, and the eutectic solvent is a mixture of ethylene glycol and choline chloride in a molar ratio of 1:1, heated to 50-60°C, and stirred until homogeneous to obtain the final product.

[0010] As a further improvement of the present invention, in step S3, the mass ratio of the active extract powder to milk exosomes is 2-4:6-7, the pH value of the PBS buffer is 7.4-7.6, the ultrasonic power of the ultrasonic co-incubation on ice is 200-400W, the time is 1-3 min, the temperature for the continued incubation is 35-38℃, the rotation speed is 200-250 r / min, and the time is 1-3 h; in step S4, the molar ratio of epigallocatechin gallate and theanine is 1:1-1.1, the amount of p-toluenesulfonic acid added is 5-10 wt% of the mass of epigallocatechin gallate, and the heating reflux extraction time is 8-10 h.

[0011] As a further improvement of the present invention, in step S5, the mass ratio of carrageenan, hydrogen peroxide, epigallocatechin gallate / theanine conjugate, loaded exosomes, emulsifier, chitosan, and calcium chloride is 10:5-8:3-5:2-3:0.5-1:4-6:0.5-1; the heating and stirring reaction temperature is 75-85°C; the time is 15-25 hours; the acid solution is a 1-3 wt% acetic acid or lactic acid solution; and the emulsifier is selected from Tween-20, Tween-40, and Tween-60. At least one of Tween-80 and Tween-85; in step S6, the mass ratio of carboxylated chitosan to NaIO4 is 10:4-5, and the stirring reaction time at room temperature in the dark is 10-15 h; in step S7, the mass ratio of oxidized carboxylated chitosan, carboxylated cellulose, sodium tetraborate, thermosensitive microcapsules, and sodium bicarbonate is 20-30:20-30:40-60:10-15:4-6, the standing time at room temperature is 20-24 h, and the heating and stirring is carried out to a temperature of 45-55℃.

[0012] This invention further protects a method for preparing the above-mentioned preparation for weight loss and lipid reduction, comprising the following steps: (1) Weigh the lotus leaves, crush them into lotus leaf powder, sieve, sterilize, and set aside; (2) Weigh out the following ingredients: Phellodendron bark, cassia seed, hawthorn, black sesame, licorice, prepared Polygonum multiflorum, and black tea. Grind them into a fine powder and set aside. (3) The fine powder in step (1) above is extracted twice by reflux with water, filtered twice, and the filtrates are collected, combined, and concentrated. (4) The liquid obtained in step (2) is concentrated, spray-dried, and mixed evenly with the lotus leaf powder, additives, hydrogel sustained-release material, linoleic acid and L-carnitine obtained in step (1) to prepare a preparation for weight loss and lipid reduction.

[0013] As a further improvement of the present invention, in step (3), the extraction is carried out twice with 6-10 times the mass of the fine powder and 4-8 times the mass of the fine powder respectively. The mixture is first soaked for 10-50 minutes, then refluxed for 1.5-3.5 hours, and concentrated to a relative density of 1.05-1.15.

[0014] As a further improvement of the present invention, the sieve mesh number in step (1) is 60-100 mesh; the medicinal liquid in step (4) is concentrated to a relative density of 1.20-1.30.

[0015] This invention further protects the use of the above-mentioned weight loss and lipid-lowering preparation in the preparation of medicines for treating obesity.

[0016] The present invention has the following beneficial effects: This invention utilizes celery, coffee beans, and corn silk. Celery contains active ingredients such as butylphthalide and apigenin, which can dilate blood vessels and aid in weight loss. Coffee beans contain chlorogenic acid, which can inhibit glucose absorption, lower insulin levels, reduce fat synthesis, and has a fat-burning effect. It can also activate enzymes related to fat metabolism (such as carnitine palmitoyltransferase), thereby promoting fat decomposition. Caffeine can increase the basal metabolic rate and promote lipid oxidation and decomposition. Corn silk contains flavonoids, polysaccharides, potassium, and other components, mainly assisting in weight loss through diuresis and swelling reduction, promoting metabolism (such as activating acyl-CoA synthase), and inhibiting sugar absorption. This invention uses a deep eutectic solvent mixed with supercritical fluid CO2 to extract active components, significantly improving the extraction rate. The supercritical fluid CO2 can combine with the deep eutectic solvent, improving the extraction rate of non-polar substances that are difficult to extract with water-soluble solvents through the principle of "like dissolves like," and is safer, more environmentally friendly, and pollution-free.

[0017] Milk contains a large number of exosomes with high transmembrane transport capacity, high stability, and low immunogenicity, making it an excellent carrier for drug delivery, and its preparation method is simple. This invention improves the transmembrane transport capacity and bioavailability of milk exosomes by loading active extract powder onto them.

[0018] Tea polyphenols are polyphenolic substances extracted from green tea, mainly catechin compounds. Epigallocatechin gallate (EGCG) is the most abundant and bioactive catechin monomer in green tea polyphenols. It possesses a polyphenolic hydroxyl structure and exhibits strong antioxidant capacity, demonstrating significant biological efficacy in anti-oxidation, anti-inflammation, anti-tumor, and anti-obesity activities. However, EGCG has poor stability; environmental conditions such as light, pH, temperature, and oxygen can cause a series of chemical reactions that destroy its structure, thereby reducing its biological activity. This invention involves esterifying EGCG with theanine to generate a conjugate. After conjugation, the antioxidant activity is greatly enhanced. Furthermore, while theanine alone may cause gastrointestinal irritation, this irritation is significantly reduced after conjugation. The conjugate works synergistically to promote fat oxidation, inhibit fat absorption and synthesis, and regulate energy metabolism, thus jointly preventing obesity and improving obesity-related indicators.

[0019] This invention encapsulates epigallocatechin gallate / theanine conjugate and loaded exosomes in thermosensitive microcapsules, oxidizes carrageenan to produce oligosaccharides to increase its solubility, and utilizes its negatively charged properties as a cross-linking agent to prepare thermosensitive microcapsules through ionic cross-linking. At body temperature (37°C), the microcapsule layer contracts to release the drug, promoting adipocyte decomposition and fatty acid transport.

[0020] This invention uses oxidized carboxylated chitosan and carboxymethyl cellulose as substrates and constructs a hydrogel network through borax-mediated dynamic bonding of borate esters. This dynamic cross-linking structure endows the material with pH responsiveness and controllable degradation characteristics. It rapidly forms a gel in the gastric acid environment. At the same time, the loaded sodium bicarbonate releases CO2 when it encounters gastric acid in the stomach, causing the gel to expand in volume, physically occupying the gastric space, delaying gastric emptying and activating satiety signals. After entering the intestine, it automatically dissolves and is excreted.

[0021] This invention also adds other components that clear heat and dampness, reduce lipids and turbidity, accelerate fat oxidation, harmonize the spleen and stomach, and reduce energy intake. It reduces fat sources and accelerates fat elimination, while improving insulin sensitivity and intestinal environment. It is suitable for obese people with damp-heat type, phlegm-dampness type, and spleen deficiency type, increases satiety, and has broad application prospects. Detailed Implementation

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below. 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.

[0023] Preparation Example 1: Hydrogel Sustained-Release Material The preparation method is as follows: S1. Preparation of milk exosomes: 100 mL of skim milk was centrifuged at 2500 g for 10 min at 4 °C. The supernatant was collected and centrifuged at 11500 g at 4 °C until no obvious precipitate was observed. The mixture was then concentrated by ultrafiltration using a 95 kDa ultrafiltration tube, purified using a qEV original column, and freeze-dried to obtain milk exosomes. S2. Preparation of active extract powder: 3g celery, 2g coffee beans and 1g corn silk were washed, dried and crushed respectively, added to 100mL deep eutectic solvent, 5g supercritical fluid CO2 was added, and the mixture was stirred and extracted for 30min at a temperature of 31℃ and a pressure of 7.4Mpa. The pressure was reduced to atmospheric pressure to release CO2, an equal volume of water was added to precipitate, filtered, washed, dried and ball-milled to obtain active extract powder; The deep eutectic solvent is prepared by mixing ethylene glycol and choline chloride in a molar ratio of 1:1, heating to 50°C, and stirring until homogeneous. S3. Loading; 2g of active extract powder and 6g of milk exosomes were added to 200mL of PBS buffer with pH 7.4, and incubated on ice at 200W for 1min. The temperature was then raised to 35℃ and incubated at 200r / min for 1h. The mixture was then freeze-dried to obtain loaded exosomes. S4. Preparation of epigallocatechin gallate / theanine conjugate: 0.1 mol epigallocatechin gallate and 0.1 mol theanine were added to 200 mL n-butanol, p-toluenesulfonic acid was added, the amount of p-toluenesulfonic acid added was 5 wt% of the mass of epigallocatechin gallate, the mixture was heated and refluxed for 8 h, an equal volume of water was added, the mixture was filtered, washed, and dried to obtain the epigallocatechin gallate / theanine conjugate; S5. Preparation of temperature-sensitive microcapsules: 10g of carrageenan was added to 200mL of water, 5g of 30wt% hydrogen peroxide was added, the mixture was heated to 75℃ and stirred for 15h, filtered, dialyzed, and the molecular weight cutoff was 100-500Da. After drying, oxidized carrageenan was obtained. It was added to 200mL of 1wt% acetic acid solution and stirred for 10min. 3g of epigallocatechin gallate / theanine conjugate, 2g of loaded exosomes and 0.5g of Tween-20 were added and stirred for 15min. 4g of chitosan was added and dropped into 500mL of fish oil. The mixture was emulsified at 8000r / min for 15min. 0.5g of calcium chloride was added and solidified at room temperature for 30min. After filtration, washing and drying, temperature-sensitive microcapsules were obtained. S6. Preparation of oxidized carboxylated chitosan: 1g of carboxylated chitosan was added to 100mL of water. Under light-protected conditions, 0.4g of NaIO4 was dissolved in 10mL of water and added to the above solution. The mixture was stirred and reacted at room temperature in the dark for 10h. 1mL of ethylene glycol was added to quench the reaction. The mixture was dialyzed with deionized water for 72h and then freeze-dried to obtain oxidized carboxylated chitosan. S7. Preparation of hydrogel sustained-release material: Dissolve 2g of oxidized carboxylated chitosan and 2g of carboxylated cellulose in 150mL of water and mix evenly. Add 4g of sodium tetraborate, heat to 45℃, stir for 10min, then add 1g of thermosensitive microcapsules and 0.4g of sodium bicarbonate, stir and mix for 15min, pour into a mold, let stand at room temperature for 20h, and freeze dry to obtain hydrogel sustained-release material.

[0024] Preparation Example 2: Hydrogel Sustained-Release Material The preparation method is as follows: S1. Preparation of milk exosomes: 100 mL of skim milk was centrifuged at 3500 g for 20 min at 4 °C. The supernatant was collected and centrifuged at 12500 g at 4 °C until no obvious precipitate was observed. The mixture was then concentrated by ultrafiltration using a 105 kDa ultrafiltration tube, purified using a qEV original column, and freeze-dried to obtain milk exosomes. S2. Preparation of active extract powder: 5g celery, 4g coffee beans and 3g corn silk were washed, dried and crushed respectively, added to 100mL deep eutectic solvent, 8g supercritical fluid CO2 was added, and the mixture was stirred and extracted for 30min at a temperature of 35℃ and a pressure of 7.8Mpa. The pressure was reduced to atmospheric pressure to release CO2, an equal volume of water was added to precipitate, filtered, washed, dried and ball-milled to obtain active extract powder; The deep eutectic solvent is prepared by mixing ethylene glycol and choline chloride in a molar ratio of 1:1, heating to 60°C, and stirring until homogeneous. S3. Loading; 4g of active extract powder and 7g of milk exosomes were added to 200mL of PBS buffer with pH 7.6, and incubated on ice at 400W for 3min. The temperature was then raised to 38℃ and incubated at 250r / min for 3h. The mixture was then freeze-dried to obtain loaded exosomes. S4. Preparation of epigallocatechin gallate / theanine conjugate: 0.1 mol epigallocatechin gallate and 0.11 mol theanine were added to 200 mL n-butanol, p-toluenesulfonic acid was added, the amount of p-toluenesulfonic acid added was 10 wt% of the mass of epigallocatechin gallate, the mixture was heated and refluxed for 10 h, an equal volume of water was added, the mixture was filtered, washed, and dried to obtain the epigallocatechin gallate / theanine conjugate; S5. Preparation of temperature-sensitive microcapsules: 10g of carrageenan was added to 200mL of water, 8g of 30wt% hydrogen peroxide was added, the mixture was heated to 85℃ and stirred for 25h, filtered, dialyzed, and the molecular weight cutoff was 100-500Da. After drying, oxidized carrageenan was obtained. It was added to 200mL of 3wt% lactic acid solution and stirred for 10min. 5g of epigallocatechin gallate / theanine conjugate, 3g of loaded exosomes and 1g of Tween-40 were added and stirred for 15min. 6g of chitosan was added and dropped into 500mL of fish oil. The mixture was emulsified at 8000r / min for 15min. 1g of calcium chloride was added and solidified at room temperature for 30min. After filtration, washing and drying, temperature-sensitive microcapsules were obtained. S6. Preparation of oxidized carboxylated chitosan: 1g of carboxylated chitosan was added to 100mL of water. 0.5g of NaIO4 was dissolved in 10mL of water and added to the above solution under light-protected conditions. The mixture was stirred and reacted at room temperature under light-protected conditions for 15h. 1mL of ethylene glycol was added to quench the reaction. The mixture was dialyzed with deionized water for 72h and then freeze-dried to obtain oxidized carboxylated chitosan. S7. Preparation of hydrogel sustained-release material: Dissolve 3g of oxidized carboxylated chitosan and 3g of carboxylated cellulose in 150mL of water and mix evenly. Add 6g of sodium tetraborate, heat to 55℃, and stir for 10min. Then add 1.5g of thermosensitive microcapsules and 0.6g of sodium bicarbonate, stir and mix for 15min, pour into a mold, let stand at room temperature for 24h, and freeze-dry to obtain hydrogel sustained-release material.

[0025] Preparation Example 3: Hydrogel Sustained-Release Material The preparation method is as follows: S1. Preparation of milk exosomes: 100 mL of skim milk was centrifuged at 3000 g for 15 min at 4 °C. The supernatant was collected and centrifuged at 12000 g at 4 °C until no obvious precipitate was observed. The mixture was then concentrated by ultrafiltration using a 100 kDa ultrafiltration tube, purified using a qEV original column, and freeze-dried to obtain milk exosomes. S2. Preparation of active extract powder: 4g celery, 3g coffee beans and 2g corn silk were washed, dried and crushed, and added to 100mL of deep eutectic solvent. 6g supercritical fluid CO2 was added and stirred for 30min at 32℃ and 7.5Mpa. The pressure was reduced to atmospheric pressure to release CO2. An equal volume of water was added to precipitate the precipitate. The precipitate was filtered, washed, dried and ball-milled to obtain active extract powder. The deep eutectic solvent is prepared by mixing ethylene glycol and choline chloride in a molar ratio of 1:1, heating to 55°C, and stirring until homogeneous. S3. Loading; 3g of active extract powder and 6.5g of milk exosomes were added to 200mL of PBS buffer with a pH of 7.5, and incubated on ice at 300W for 2min. The temperature was then raised to 36℃ and incubated at 220r / min for another 2h. The mixture was then freeze-dried to obtain loaded exosomes. S4. Preparation of epigallocatechin gallate / theanine conjugate: 0.1 mol epigallocatechin gallate and 0.105 mol theanine were added to 200 mL n-butanol, p-toluenesulfonic acid was added, the amount of p-toluenesulfonic acid added was 7 wt% of the mass of epigallocatechin gallate, the mixture was heated and refluxed for 9 h, an equal volume of water was added, the mixture was filtered, washed, and dried to obtain the epigallocatechin gallate / theanine conjugate; S5. Preparation of temperature-sensitive microcapsules: 10g of carrageenan was added to 200mL of water, 6g of 30wt% hydrogen peroxide was added, the mixture was heated to 80℃ and stirred for 20h, filtered, dialyzed, and the molecular weight cutoff was 100-500Da. After drying, oxidized carrageenan was obtained. It was added to 200mL of 2wt% acetic acid solution and stirred for 10min. 4g of epigallocatechin gallate / theanine conjugate, 2.5g of loaded exosomes and 0.7g of Tween-80 were added and stirred for 15min. 5g of chitosan was added and dropped into 500mL of fish oil. The mixture was emulsified at 8000r / min for 15min. 0.7g of calcium chloride was added and solidified at room temperature for 30min. After filtration, washing and drying, temperature-sensitive microcapsules were obtained. S6. Preparation of oxidized carboxylated chitosan: 1g of carboxylated chitosan was added to 100mL of water. Under light-protected conditions, 0.45g of NaIO4 was dissolved in 10mL of water and added to the above solution. The mixture was stirred and reacted at room temperature in the dark for 12h. 1mL of ethylene glycol was added to quench the reaction. The mixture was dialyzed with deionized water for 72h and then freeze-dried to obtain oxidized carboxylated chitosan. S7. Preparation of hydrogel sustained-release material: Dissolve 2.5g of oxidized carboxylated chitosan and 2.5g of carboxylated cellulose in 150mL of water and mix evenly. Add 5g of sodium tetraborate, heat to 50℃, and stir for 10min. Then add 1.2g of thermosensitive microcapsules and 0.5g of sodium bicarbonate, stir and mix for 15min, pour into a mold, let stand at room temperature for 22h, and freeze-dry to obtain hydrogel sustained-release material.

[0026] Test Example 1 The temperature-sensitive microcapsules prepared in step S5 of Examples 1-3 were added to water and immersed in water at different temperatures for 24 hours to reach equilibrium. After swelling equilibrium, the surface moisture was absorbed with filter paper, and the equilibrium mass at each temperature was recorded. Each measurement was performed in triplicate, and the equilibrium swelling rate was calculated. : in, It is the mass of the hydrogel at 24 hours. It is the mass of the gel when it dries to a constant weight at the initial moment.

[0027] The results are shown in Table 1: Table 1 As shown in the table above, the thermosensitive microcapsules prepared in step S5 of Examples 1-3 of the present invention have an equilibrium swelling rate around body temperature of 37°C. The shell contracts, releasing the drug.

[0028] Comparative Preparation Example 1 The difference compared to Preparation Example 3 is that the active extract powder was not loaded with milk exosomes.

[0029] Specifically as follows: S1. Preparation of active extract powder: 4g celery, 3g coffee beans and 2g corn silk were washed, dried and crushed respectively, added to 100mL deep eutectic solvent, 6g supercritical fluid CO2 was added, and the mixture was stirred and extracted for 30min at a temperature of 32℃ and a pressure of 7.5Mpa. The pressure was reduced to atmospheric pressure to release CO2, an equal volume of water was added to precipitate, filtered, washed, dried and ball-milled to obtain active extract powder; The deep eutectic solvent is prepared by mixing ethylene glycol and choline chloride in a molar ratio of 1:1, heating to 55°C, and stirring until homogeneous. S2. Preparation of epigallocatechin gallate / theanine conjugate: 0.1 mol epigallocatechin gallate and 0.105 mol theanine were added to 200 mL n-butanol, p-toluenesulfonic acid was added, the amount of p-toluenesulfonic acid added was 7 wt% of the mass of epigallocatechin gallate, the mixture was heated and refluxed for 9 h, an equal volume of water was added, the mixture was filtered, washed, and dried to obtain the epigallocatechin gallate / theanine conjugate; S3. Preparation of temperature-sensitive microcapsules: 10g of carrageenan was added to 200mL of water, 6g of 30wt% hydrogen peroxide was added, the mixture was heated to 80℃ and stirred for 20h, filtered, dialyzed, and the molecular weight cutoff was 100-500Da. After drying, oxidized carrageenan was obtained. It was added to 200mL of 2wt% acetic acid solution and stirred for 10min. 4g of epigallocatechin gallate / theanine conjugate, 2.5g of loaded exosomes and 0.7g of Tween-80 were added and stirred for 15min. 5g of chitosan was added and dropped into 500mL of fish oil. The mixture was emulsified at 8000r / min for 15min. 0.7g of calcium chloride was added and solidified at room temperature for 30min. After filtration, washing and drying, temperature-sensitive microcapsules were obtained. S4. Preparation of oxidized carboxylated chitosan: 1g of carboxylated chitosan was added to 100mL of water. Under light-protected conditions, 0.45g of NaIO4 was dissolved in 10mL of water and added to the above solution. The mixture was stirred and reacted at room temperature in the dark for 12h. 1mL of ethylene glycol was added to quench the reaction. The mixture was dialyzed with deionized water for 72h and then freeze-dried to obtain oxidized carboxylated chitosan. S5. Preparation of hydrogel sustained-release material: 2.5g of oxidized carboxylated chitosan and 2.5g of carboxylated cellulose were dissolved in 150mL of water and mixed evenly. 5g of sodium tetraborate was added, heated to 50℃, and stirred for 10min. Then, 1.2g of thermosensitive microcapsules and 0.5g of sodium bicarbonate were added, and stirred for 15min. The mixture was poured into a mold, allowed to stand at room temperature for 22h, and then freeze-dried to obtain the hydrogel sustained-release material.

[0030] Comparative Preparation Example 2 Compared with Preparation Example 3, the difference is that the epigallocatechin gallate / theanine conjugate is replaced by an equal mass mixture of epigallocatechin gallate and theanine, wherein the molar ratio of epigallocatechin gallate to theanine in the mixture is 1:1.05.

[0031] Comparative preparation example 3 The difference from preparation example 3 is that step S5 was not performed.

[0032] Specifically as follows: S1. Preparation of milk exosomes: 100 mL of skim milk was centrifuged at 3000 g for 15 min at 4 °C. The supernatant was collected and centrifuged at 12000 g at 4 °C until no obvious precipitate was observed. The mixture was then concentrated by ultrafiltration using a 100 kDa ultrafiltration tube, purified using a qEV original column, and freeze-dried to obtain milk exosomes. S2. Preparation of active extract powder: 4g celery, 3g coffee beans and 2g corn silk were washed, dried and crushed, and added to 100mL of deep eutectic solvent. 6g supercritical fluid CO2 was added and stirred for 30min at 32℃ and 7.5Mpa. The pressure was reduced to atmospheric pressure to release CO2. An equal volume of water was added to precipitate the precipitate. The precipitate was filtered, washed, dried and ball-milled to obtain active extract powder. The deep eutectic solvent is prepared by mixing ethylene glycol and choline chloride in a molar ratio of 1:1, heating to 55°C, and stirring until homogeneous. S3. Loading; 3g of active extract powder and 6.5g of milk exosomes were added to 200mL of PBS buffer with a pH of 7.5, and incubated on ice at 300W for 2min. The temperature was then raised to 36℃ and incubated at 220r / min for another 2h. The mixture was then freeze-dried to obtain loaded exosomes. S4. Preparation of epigallocatechin gallate / theanine conjugate: 0.1 mol epigallocatechin gallate and 0.105 mol theanine were added to 200 mL n-butanol, p-toluenesulfonic acid was added, the amount of p-toluenesulfonic acid added was 7 wt% of the mass of epigallocatechin gallate, the mixture was heated and refluxed for 9 h, an equal volume of water was added, the mixture was filtered, washed, and dried to obtain the epigallocatechin gallate / theanine conjugate; S5. Preparation of oxidized carboxylated chitosan: 1g of carboxylated chitosan was added to 100mL of water. Under light-protected conditions, 0.45g of NaIO4 was dissolved in 10mL of water and added to the above solution. The mixture was stirred and reacted at room temperature in the dark for 12h. 1mL of ethylene glycol was added to quench the reaction. The mixture was dialyzed with deionized water for 72h and then freeze-dried to obtain oxidized carboxylated chitosan. S6. Preparation of hydrogel sustained-release material: 2.5g of oxidized carboxylated chitosan and 2.5g of carboxylated cellulose were dissolved in 150mL of water and mixed evenly. 5g of sodium tetraborate was added, heated to 50℃, and stirred for 10min. Then, 1.2g of mixture (including epigallocatechin gallate / theanine conjugate and loaded exosomes in a mass ratio of 3:2) and 0.5g of sodium bicarbonate were added and stirred for 15min. The mixture was poured into a mold, allowed to stand at room temperature for 22h, and then freeze-dried to obtain the hydrogel sustained-release material.

[0033] Comparative preparation example 4 The difference compared to preparation example 3 is that steps S6 and S7 were not performed.

[0034] Specifically as follows: S1. Preparation of milk exosomes: 100 mL of skim milk was centrifuged at 3000 g for 15 min at 4 °C. The supernatant was collected and centrifuged at 12000 g at 4 °C until no obvious precipitate was observed. The mixture was then concentrated by ultrafiltration using a 100 kDa ultrafiltration tube, purified using a qEV original column, and freeze-dried to obtain milk exosomes. S2. Preparation of active extract powder: 4g celery, 3g coffee beans and 2g corn silk were washed, dried and crushed, and added to 100mL of deep eutectic solvent. 6g supercritical fluid CO2 was added and stirred for 30min at 32℃ and 7.5Mpa. The pressure was reduced to atmospheric pressure to release CO2. An equal volume of water was added to precipitate the precipitate. The precipitate was filtered, washed, dried and ball-milled to obtain active extract powder. The deep eutectic solvent is prepared by mixing ethylene glycol and choline chloride in a molar ratio of 1:1, heating to 55°C, and stirring until homogeneous. S3. Loading; 3g of active extract powder and 6.5g of milk exosomes were added to 200mL of PBS buffer with a pH of 7.5, and incubated on ice at 300W for 2min. The temperature was then raised to 36℃ and incubated at 220r / min for another 2h. The mixture was then freeze-dried to obtain loaded exosomes. S4. Preparation of epigallocatechin gallate / theanine conjugate: 0.1 mol epigallocatechin gallate and 0.105 mol theanine were added to 200 mL n-butanol, p-toluenesulfonic acid was added, the amount of p-toluenesulfonic acid added was 7 wt% of the mass of epigallocatechin gallate, the mixture was heated and refluxed for 9 h, an equal volume of water was added, the mixture was filtered, washed, and dried to obtain the epigallocatechin gallate / theanine conjugate; S5. Preparation of temperature-sensitive microcapsules: 10g of carrageenan was added to 200mL of water, along with 6g of 30wt% hydrogen peroxide. The mixture was heated to 80℃ and stirred for 20h. After filtration and dialyzing, the molecular weight cutoff was 100-500Da. The mixture was dried to obtain oxidized carrageenan. This oxidized carrageenan was added to 200mL of 2wt% acetic acid solution and stirred for 10min. Then, 4g of epigallocatechin gallate / theanine conjugate, 2.5g of loaded exosomes, and 0.7g of Tween-80 were added and stirred for 15min. Finally, 5g of chitosan was added and dropped into 500mL of fish oil. The mixture was emulsified at 8000r / min for 15min. 0.7g of calcium chloride was added and the mixture was cured at room temperature for 30min. After filtration, washing, and drying, temperature-sensitive microcapsules were obtained, which are the hydrogel sustained-release materials.

[0035] Comparative preparation example 5 The difference from Preparation Example 3 is that sodium bicarbonate was not added in step S7.

[0036] Specifically as follows: S7. Preparation of hydrogel sustained-release material: Dissolve 2.5g of oxidized carboxylated chitosan and 2.5g of carboxylated cellulose in 150mL of water and mix evenly. Add 5g of sodium tetraborate, heat to 50℃, stir for 10min, then add 1.2g of thermosensitive microcapsules, stir and mix for 15min, pour into a mold, let stand at room temperature for 22h, and freeze dry to obtain hydrogel sustained-release material.

[0037] Test Example 2 The hydrogel sustained-release materials prepared in Preparation Examples 1-3 and Comparative Preparation Example 5 were added to PBS buffer (phosphate buffer) and immersed for equilibration for 24 hours under different pH conditions. After swelling equilibration, the surface moisture was blotted dry with filter paper, and the equilibration mass was recorded under each pH condition. Each measurement was performed in triplicate, and the equilibrium swelling rate was calculated. : in, It is the mass of the hydrogel at 24 hours. It is the mass of the gel when it dries to a constant weight at the initial moment.

[0038] The results are shown in Table 2: Table 2 As can be seen from the table above, the hydrogel sustained-release materials prepared in Examples 1-3 of the present invention rapidly form gels under acidic conditions. At the same time, the loaded sodium bicarbonate releases CO2 upon contact with acid, causing the gel volume to expand and further improving the swelling performance.

[0039] Example 1 Raw material composition (parts by weight): 150 parts Phellodendron bark, 5 parts linoleic acid, 1 part L-carnitine, 50 parts cassia seed, 51 parts lotus leaf, 50 parts processed Polygonum multiflorum, 40 parts hawthorn, 40 parts black sesame, 20 parts licorice, 20 parts black tea, 5 parts additives, and 20 parts of the hydrogel sustained-release material prepared in Example 1. The additives include zinc lactate, ferrous lactate, selenium-enriched yeast, thiamine hydrochloride, riboflavin, and pyridoxine hydrochloride, in a mass ratio of 1:2:5:1:1:2.

[0040] The preparation method includes the following steps: (1) Weigh the lotus leaves, crush them into lotus leaf powder, pass them through a 60-mesh sieve, sterilize them, and set them aside; (2) Weigh out the following ingredients: Phellodendron bark, cassia seed, hawthorn, black sesame, licorice, prepared Polygonum multiflorum, and black tea. Grind them into a fine powder and set aside. (3) The fine powder in step (1) above is extracted twice by reflux with water. The two extractions are respectively 6 times the mass of the fine powder and 4 times the mass of the fine powder. First soak for 10 min, then heat and reflux for 1.5 h. Filter twice, collect the two filtrates, combine the filtrates, and concentrate to a relative density of 1.05. (4) The liquid obtained in step (2) is concentrated to a relative density of 1.20, spray-dried, and mixed evenly with the lotus leaf powder, additives, hydrogel sustained-release material, linoleic acid and L-carnitine obtained in step (1) to prepare a preparation for weight loss and lipid reduction.

[0041] Example 2 Raw material composition (parts by weight): 250 parts Phellodendron bark, 15 parts linoleic acid, 5 parts L-carnitine, 90 parts cassia seed, 89 parts lotus leaf, 80 parts processed Polygonum multiflorum, 60 parts hawthorn, 60 parts black sesame, 40 parts licorice, 40 parts black tea, 10 parts additives, and 40 parts of the hydrogel sustained-release material prepared in Preparation Example 2. The additives include zinc lactate, ferrous lactate, selenium-enriched yeast, thiamine hydrochloride, riboflavin, and pyridoxine hydrochloride, in a mass ratio of 3:5:10:2:2:4.

[0042] The preparation method includes the following steps: (1) Weigh the lotus leaves, crush them into lotus leaf powder, pass them through a 100-mesh sieve, sterilize them, and set them aside; (2) Weigh out the following ingredients: Phellodendron bark, cassia seed, hawthorn, black sesame, licorice, prepared Polygonum multiflorum, and black tea. Grind them into a fine powder and set aside. (3) The fine powder in step (1) above is extracted twice by reflux with water. The two extractions are respectively 10 times the weight of the fine powder and 8 times the weight of the fine powder. First soak for 50 min, then heat and reflux for 3.5 h. Filter twice, collect the two filtrates, combine the filtrates, and concentrate to a relative density of 1.15. (4) The liquid obtained in step (2) is concentrated to a relative density of 1.30, spray-dried, and mixed evenly with the lotus leaf powder, additives, hydrogel sustained-release material, linoleic acid and L-carnitine obtained in step (1) to prepare a preparation for weight loss and lipid reduction.

[0043] Example 3 Raw material composition (parts by weight): 200 parts Phellodendron bark, 10 parts linoleic acid, 3 parts L-carnitine, 65 parts cassia seed, 65 parts lotus leaf, 65 parts processed Polygonum multiflorum, 50 parts hawthorn, 50 parts black sesame, 30 parts licorice, 30 parts black tea, 7 parts additives, and 30 parts of the hydrogel sustained-release material prepared in Preparation Example 3. The additives include zinc lactate, ferrous lactate, selenium-enriched yeast, thiamine hydrochloride, riboflavin, and pyridoxine hydrochloride, in a mass ratio of 2:3:7:1.5:1.5:3.

[0044] The preparation method includes the following steps: (1) Weigh the lotus leaves, crush them into lotus leaf powder, pass them through an 80-mesh sieve, sterilize them, and set them aside; (2) Weigh out the following ingredients: Phellodendron bark, cassia seed, hawthorn, black sesame, licorice, prepared Polygonum multiflorum, and black tea. Grind them into a fine powder and set aside. (3) The fine powder in step (1) above is extracted twice by reflux with water. The two extractions are respectively 8 times the mass of the fine powder and 6 times the mass of the fine powder. First soak for 30 minutes, then heat and reflux for 2.5 hours. Filter twice, collect the two filtrates, combine the filtrates, and concentrate to a relative density of 1.1. (4) The liquid obtained in step (2) is concentrated to a relative density of 1.25, spray-dried, and mixed evenly with the lotus leaf powder, additives, hydrogel sustained-release material, linoleic acid and L-carnitine obtained in step (1) to prepare a preparation for weight loss and lipid reduction.

[0045] Comparative Example 1 The difference from Example 3 is that the hydrogel sustained-release material was prepared by Comparative Preparation Example 1.

[0046] Comparative Example 2 The difference from Example 3 is that the hydrogel sustained-release material was prepared from Comparative Preparation Example 2.

[0047] Comparative Example 3 The difference from Example 3 is that the hydrogel sustained-release material was prepared by Comparative Preparation Example 3.

[0048] Comparative Example 4 The difference from Example 3 is that the hydrogel sustained-release material was prepared by Comparative Preparation Example 4.

[0049] Comparative Example 5 The difference from Example 3 is that the hydrogel sustained-release material was prepared from Comparative Preparation Example 5.

[0050] Comparative Example 6 The difference compared to Example 3 is that no hydrogel sustained-release material was added.

[0051] Comparative Example 7 The difference compared to Example 3 is that no additives were added.

[0052] Test Example 3 Male ICR mice aged 7-8 weeks, weighing 22-24g, were randomly divided into a blank control group, a model group, a positive control group, groups of Examples 1-3, and groups of Comparative Examples 1-7. Except for the blank control group, all other groups were fed a high-fat diet, while the blank control group was fed a normal diet. Modeling was successful at 8 weeks, and gavage was initiated. Mice were allowed one week of acclimatization before gavage. After successful modeling, mice were administered 2g / mouse / day via gavage of the weight-loss and lipid-lowering formulation prepared in Examples 1-3 or Comparative Examples 1-7. The blank control group and model group received an equal volume of physiological saline. The positive control group received an equal volume of L-carnitine. The experiment lasted for one month.

[0053] Measurement of four indicators in mice: body weight, water intake, and blood lipids: After the experiment, the body weight of all experimental animals was measured.

[0054] The results are shown in Table 3: Table 3 Note: Compared with the blank control group, P<0.05; Compared with the model group, P < 0.05.

[0055] As can be seen from the table above, the preparations for weight loss and lipid reduction obtained in Examples 1-3 of the present invention can significantly reduce the body weight of mice.

[0056] After the experiment, 5 mL of blood was taken from the mice using the cardiac blood sampling method. The blood was then centrifuged and immediately tested for total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).

[0057] The results are shown in Table 4: Table 4 Note: Compared with the blank control group, P<0.05; Compared with the model group, P < 0.05.

[0058] As can be seen from the table above, the preparations for weight loss and lipid reduction obtained in Examples 1-3 of the present invention have good lipid-lowering effects.

[0059] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A preparation for weight loss and lipid reduction, characterized in that, The raw materials include the following parts by weight: 150-250 parts of Phellodendron bark, 5-15 parts of linoleic acid, 1-5 parts of L-carnitine, 50-90 parts of cassia seed, 51-89 parts of lotus leaf, 50-80 parts of processed Polygonum multiflorum, 40-60 parts of hawthorn, 40-60 parts of black sesame, 20-40 parts of licorice, 20-40 parts of black tea, 5-10 parts of additives, and 20-40 parts of hydrogel sustained-release material. The hydrogel sustained-release material is a pH-responsive gastric volume-carrying hydrogel loaded with temperature-sensitive microcapsules. The temperature-sensitive microcapsules are loaded with epigallocatechin gallate / theanine conjugate and exosomes loaded with active extracts.

2. The preparation for weight loss and lipid reduction according to claim 1, characterized in that, The additives include zinc lactate, ferrous lactate, selenium-enriched yeast, thiamine hydrochloride, riboflavin, and pyridoxine hydrochloride, in a mass ratio of 1-3:2-5:5-10:1-2:1-2:2-4.

3. The preparation for weight loss and lipid reduction according to claim 1, characterized in that, The preparation method of the hydrogel sustained-release material is as follows: S1. Preparation of milk exosomes: Skim milk was initially centrifuged to obtain the supernatant, then centrifuged deeply until no obvious precipitate was found, concentrated by ultrafiltration, purified by chromatographic column, and freeze-dried to obtain milk exosomes; S2. Preparation of active extract powder: Celery, coffee beans and corn silk are washed, dried and crushed, added to a deep eutectic solvent, and supercritical fluid CO2 is added. Under critical conditions, the mixture is stirred and extracted, the CO2 is released by depressurization, water is added to precipitate, filtered, washed, dried and ball-milled to obtain active extract powder. S3. Loading; The active extract powder and milk exosomes were added to PBS buffer, sonicated on ice, heated and incubated for a longer period, and then freeze-dried to obtain loaded exosomes; S4. Preparation of epigallocatechin gallate / theanine conjugate: Epigallocatechin gallate and theanine were added to n-butanol, p-toluenesulfonic acid was added, the mixture was heated under reflux for extraction, water was added, the mixture was filtered, washed, and dried to obtain the epigallocatechin gallate / theanine conjugate. S5. Preparation of temperature-sensitive microcapsules: Carrageenan was added to water, hydrogen peroxide was added, the mixture was heated and stirred to react, filtered, dialyzed, and dried to obtain oxidized carrageenan. The oxidized carrageenan was added to acid solution and stirred to mix evenly. Epigallocatechin gallate / theanine conjugate, loaded exosomes and emulsifier were added and stirred to mix evenly. Chitosan was added and added dropwise to fish oil. The mixture was emulsified, calcium chloride was added, and the mixture was cured at room temperature. The mixture was filtered, washed, and dried to obtain temperature-sensitive microcapsules. S6. Preparation of oxidized carboxylated chitosan: Carboxylated chitosan was added to water, NaIO4 was dissolved in water under light-protected conditions, and added to the above solution. The reaction was stirred at room temperature under light-protected conditions, the reaction was quenched by adding ethylene glycol, dialyzed, and freeze-dried to obtain oxidized carboxylated chitosan. S7. Preparation of hydrogel sustained-release material: Oxidized carboxylated chitosan and carboxylated cellulose were dissolved in water and mixed evenly. Sodium tetraborate was added, and the mixture was heated and stirred. Then, thermosensitive microcapsules and sodium bicarbonate were added and stirred evenly. The mixture was poured into a mold, allowed to stand at room temperature, and then freeze-dried to obtain the hydrogel sustained-release material.

4. The preparation for weight loss and lipid reduction according to claim 3, characterized in that, In step S1, the initial centrifugation conditions are 4℃, 2500-3500g for 10-20min; the deep centrifugation conditions are 4℃, 11500-12500g; the ultrafiltration concentration uses an ultrafiltration tube of 95-105ku; and the chromatographic column is a qEV original column. In step S2, the mass ratio of celery, coffee beans, and corn silk is 3-5:2-4:1-3; the mass ratio of the eutectic solvent and supercritical fluid CO2 is 100:5-8; the critical conditions are a temperature of 31-35℃ and a pressure of 7.4-7.8 MPa; the pressure is reduced to atmospheric pressure; and the eutectic solvent is a mixture of ethylene glycol and choline chloride in a 1:1 molar ratio, heated to 50-60℃, and stirred until homogeneous.

5. The preparation for weight loss and lipid reduction according to claim 3, characterized in that, In step S3, the mass ratio of the active extract powder to milk exosomes is 2-4:6-7; the pH of the PBS buffer is 7.4-7.6; the ultrasonic power for co-incubation on ice is 200-400W for 1-3 min; the temperature for further incubation is 35-38℃, the rotation speed is 200-250 r / min, and the time is 1-3 h; in step S4, the molar ratio of epigallocatechin gallate to theanine is 1:1-1.1; the amount of p-toluenesulfonic acid added is 5-10 wt% of the mass of epigallocatechin gallate; and the extraction time by reflux is 8-10 h.

6. The preparation for weight loss and lipid reduction according to claim 3, characterized in that, In step S5, the mass ratio of carrageenan, hydrogen peroxide, epigallocatechin gallate / theanine conjugate, loaded exosomes, emulsifier, chitosan, and calcium chloride is 10:5-8:3-5:2-3:0.5-1:4-6:0.5-1. The heating and stirring reaction is carried out at a temperature of 75-85°C for 15-25 hours. The acid solution is a 1-3 wt% acetic acid or lactic acid solution. The emulsifier is selected from Tween-20, Tween-40, Tween-60, and Tween-80. At least one of Tween-85; in step S6, the mass ratio of carboxylated chitosan to NaIO4 is 10:4-5, and the stirring reaction time at room temperature in the dark is 10-15 h; in step S7, the mass ratio of oxidized carboxylated chitosan, carboxylated cellulose, sodium tetraborate, thermosensitive microcapsules, and sodium bicarbonate is 20-30:20-30:40-60:10-15:4-6, the standing time at room temperature is 20-24 h, and the heating and stirring is carried out to a temperature of 45-55℃.

7. A method for preparing a formulation for weight loss and lipid reduction as described in any one of claims 1-6, characterized in that, Includes the following steps: (1) Weigh the lotus leaves, crush them into lotus leaf powder, sieve, sterilize, and set aside; (2) Weigh out the following ingredients: Phellodendron bark, cassia seed, hawthorn, black sesame, licorice, prepared Polygonum multiflorum, and black tea. Grind them into a fine powder and set aside. (3) The fine powder in step (1) above is extracted twice by reflux with water, filtered twice, and the filtrates are collected, combined, and concentrated. (4) The liquid obtained in step (2) is concentrated, spray-dried, and mixed evenly with the lotus leaf powder, additives, hydrogel sustained-release material, linoleic acid and L-carnitine obtained in step (1) to prepare a preparation for weight loss and lipid reduction.

8. The preparation method according to claim 7, characterized in that, In step (3), the extraction is carried out twice, with 6-10 times the weight of the fine powder in water and 4-8 times the weight of the fine powder in water respectively. First, soak for 10-50 minutes, then reflux for 1.5-3.5 hours, and concentrate to a relative density of 1.05-1.

15.

9. The preparation method according to claim 7, characterized in that, In step (1), the sieve mesh size is 60-100 mesh; in step (4), the medicinal liquid is concentrated to a relative density of 1.20-1.

30.

10. The use of a weight-loss and lipid-lowering formulation as described in any one of claims 1-6 in the preparation of a medicine for treating obesity.

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