A composition, its preparation and use

Abstract

The present application relates to the technical field of food / functional food or health food, in particular to a composition and its preparation method and application.The composition comprises the following components: coffee raw materials, herbal extract; the preparation raw materials of the herbal extract comprise green tea, bitter gourd, licorice, cassia seed and lotus leaf; the preparation method of the herbal extract comprises the following steps: (1) mixing the preparation raw materials according to the proportion, extracting by water to obtain an extract; (2) the extract is subjected to enzymatic hydrolysis treatment by cellulase, pectinase, cellobiase and tannase, and solid-liquid separation, and the liquid phase is the herbal extract.The composition of the present application can effectively inhibit fat absorption, has good weight loss effect, and can reduce body weight, BMI index, waist circumference, hip circumference, abdominal fat thickness and adverse eating behavior.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a composition, its preparation method, and its application. Background Technology

[0002] With the improvement of people's living standards, obesity is becoming increasingly prevalent. Obesity is not only a significant contributing factor to diseases such as diabetes, hypertension, cardiovascular and cerebrovascular diseases, and even some cancers, but it also easily leads to social and psychological problems. The prevention and treatment of obesity are crucial for improving the overall health of individuals and society. Current treatment methods mainly include lifestyle interventions (diet and physical exercise), medication, and surgery. Surgery carries certain risks, and weight-loss drugs have drawbacks such as unclear safety profiles and significant side effects. Continued efforts are needed to find safe weight-loss medications. Summary of the Invention

[0003] The present invention aims to solve the technical problems existing in the prior art. To this end, the present invention proposes a composition.

[0004] In one aspect, the present invention provides a composition comprising the following components: coffee raw material and herbal extract;

[0005] The raw materials for preparing the herbal extract include green tea, bitter melon, licorice, cassia seed, and lotus leaf; the preparation method of the herbal extract includes the following steps:

[0006] (1) The raw materials are mixed according to the specified ratio and extracted with water to obtain an extract;

[0007] (2) The extract is subjected to enzymatic hydrolysis by cellulase, pectinase, cellobiase and tanninase, and after solid-liquid separation, the liquid phase is the herbal extract.

[0008] In some embodiments of the present invention, the composition comprises, by weight, 1700-2000 parts of coffee raw material and herbal extract; the raw materials for preparing the herbal extract include 50-60 parts of green tea, 35-45 parts of bitter melon, 30-35 parts of licorice, 30-35 parts of cassia seed, and 35-45 parts of lotus leaf.

[0009] In some embodiments of the present invention, the composition comprises, by weight, 1850-1900 parts of coffee raw material and herbal extract; the raw materials for preparing the herbal extract include 52-56 parts of green tea, 38-42 parts of bitter melon, 31-35 parts of licorice, 31-35 parts of cassia seed, and 38-42 parts of lotus leaf.

[0010] In some embodiments of the present invention, the composition comprises, by weight, 1875 parts coffee raw material and herbal extract; the raw materials for preparing the herbal extract include 54 parts green tea, 40 parts bitter melon, 33 parts licorice, 33 parts cassia seed, and 40 parts lotus leaf.

[0011] In some embodiments of the present invention, the coffee raw material includes at least one of coffee concentrate, coffee powder, and coffee extract.

[0012] In some embodiments of the present invention, the soluble solids content of the coffee raw material is not less than 9 wt%. For example, it can be 9 wt%, 9.5 wt%, 10 wt%, 10.5 wt%, 11 wt%, 11.5 wt%, 12 wt%, 12.5 wt%, 13 wt%, 13.5 wt%, 14 wt%, 14.5 wt%, 15 wt%, 15.5 wt%, 16 wt%, 16.5 wt%, 17 wt%, 17.5 wt%, 18 wt%, 18.5 wt%, 19 wt%, 19.5 wt%, or 20 wt%.

[0013] In some embodiments of the present invention, the caffeine (alkali) content of the coffee raw material is not less than 0.2 wt%. For example, it can be 0.2 wt%, 0.21 wt%, 0.22 wt%, 0.23 wt%, 0.24 wt%, 0.25 wt%, 0.26 wt%, 0.27 wt%, 0.28 wt%, 0.29 wt%, 0.30 wt%, 0.31 wt%, 0.32 wt%, 0.33 wt%, 0.34 wt%, 0.35 wt%, 0.36 wt%, 0.37 wt%, 0.38 wt%, 0.39 wt%, 0.40 wt%, 0.41 wt%, 0.42 wt%, 0.43 wt%, 0.44 wt%, 0.45 wt%, 0.46 wt%, 0.47 wt%, 0.48 wt%, 0.49 wt%, or 0.5 wt%.

[0014] In some embodiments of the present invention, in step (1), the extraction process includes: adding water in amounts 6 to 13 times the total mass of the raw materials each time, heating to boiling, and obtaining the extract through solid-liquid separation. For example, the amount of water added can be 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, or 13 times the total mass of the raw materials.

[0015] In some embodiments of the present invention, the extraction is repeated 1-5 times. For example, it can be 1, 2, 3, 4, or 5 times. The repeated extraction is 3 times, including: first adding 11-13 times the total mass of the raw materials to water, heating and boiling, and obtaining extract a through a first solid-liquid separation; second adding 9-11 times the total mass of the raw materials to water, heating and boiling, and obtaining extract b through a second solid-liquid separation and filtration; third adding 6-11 times the total mass of the raw materials to water, heating and boiling, and obtaining extract c through a third solid-liquid separation; and combining extract a, extract b, and extract c.

[0016] In some embodiments of the present invention, the heating and boiling time is 0.5 h to 3 h. For example, it can be 0.5 h, 0.6 h, 0.7 h, 0.8 h, 0.9 h, 1 h, 1.1 h, 1.2 h, 1.3 h, 1.4 h, 1.5 h, 1.6 h, 1.7 h, 1.8 h, 1.9 h, 2 h, 2.1 h, 2.2 h, 2.3 h, 2.4 h, 2.5 h, 2.6 h, 2.7 h, 2.8 h, 2.9 h, or 3 h.

[0017] In some embodiments of the present invention, the first solid-liquid separation, the second solid-liquid separation, and / or the third solid-liquid separation include, but are not limited to, filtration and centrifugation. The filtration is performed using a 100-250 mesh filter. For example, the mesh size of the filter can be 100, 115, 120, 125, 130, 140, 150, 160, 170, 175, 180, 200, 230, 240, or 250.

[0018] In some embodiments of the present invention, the extraction process further includes subjecting the extract to a first concentration treatment. Preferably, the extract is concentrated to a relative density of 1.0 g / cm³. 3 -1.1 g / cm 3 (Measured at 65℃). For example: it can be 1.0 g / cm³. 3 1.01 g / cm 3 1.02 g / cm 3 1.03 g / cm 3 1.04 g / cm 3 1.05 g / cm 3 1.06 g / cm 3 1.07 g / cm 3 1.08 g / cm 3 1.09 g / cm 3 Or 1.1 g / cm 3 .

[0019] In some embodiments of the present invention, the first concentration process is vacuum concentration. The temperature of the vacuum concentration is 65°C to 75°C (e.g., 65°C, 66°C, 67°C, 68°C, 69°C, 70°C, 71°C, 72°C, 73°C, 74°C, or 75°C). The vacuum degree of the vacuum concentration is -0.04 MPa to -0.08 MPa (e.g., -0.04 MPa, -0.05 MPa, -0.06 MPa, -0.07 MPa, or -0.08 MPa).

[0020] In some embodiments of the present invention, in step (2), the amount of cellulase, pectinase, cellobiase and / or tanninase is 1wt‰-2wt‰ of the mass of the extract. For example, it can be 1.1wt‰, 1.2wt‰, 1.3wt‰, 1.4wt‰, 1.5wt‰, 1.6wt‰, 1.7wt‰, 1.8wt‰, 1.9wt‰ or 2wt‰.

[0021] In some embodiments of the present invention, the enzymatic hydrolysis time is 4 h to 16 h. For example, it can be 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 10 h, 11 h, 12 h, 13 h, 14 h, 15 h or 16 h.

[0022] In some embodiments of the present invention, the temperature of the enzymatic hydrolysis treatment is 40℃-55℃. For example, it can be 40℃, 41℃, 42℃, 43℃, 44℃, 45℃, 46℃, 47℃, 48℃, 49℃, 50℃, 51℃, 52℃, 53℃, 54℃ or 55℃.

[0023] In some embodiments of the present invention, the enzymatic hydrolysis treatment further includes enzyme inactivation treatment after enzymatic hydrolysis and a second concentration treatment.

[0024] In some embodiments of the present invention, the enzyme inactivation treatment includes heating and boiling for 20-40 minutes. For example, it can be 20 minutes, 21 minutes, 22 minutes, 23 minutes, 24 minutes, 25 minutes, 26 minutes, 27 minutes, 28 minutes, 29 minutes, 30 minutes, 31 minutes, 32 minutes, 33 minutes, 34 minutes, 35 minutes, 36 minutes, 37 minutes, 38 minutes, 39 minutes, or 40 minutes.

[0025] In some embodiments of the present invention, the second concentration treatment concentrates the enzymatic hydrolysate to a relative density of 1.05 g / cm³. 3 -1.15 g / cm 3(Measured at 65℃). For example: it can be 1.05 g / cm³. 3 1.06 g / cm 3 1.07 g / cm 3 1.08 g / cm 3 1.09 g / cm 3 1.10 g / cm 3 1.11 g / cm 3 1.12 g / cm 3 1.13 g / cm 3 1.14 g / cm 3 Or 1.15 g / cm 3 .

[0026] In some embodiments of the present invention, the second concentration process is vacuum concentration. The vacuum concentration temperature is 65°C to 75°C (e.g., 65°C, 66°C, 67°C, 68°C, 69°C, 70°C, 71°C, 72°C, 73°C, 74°C, or 75°C). The vacuum degree of the vacuum concentration is -0.04 MPa to -0.08 MPa (e.g., -0.04 MPa, -0.05 MPa, -0.06 MPa, -0.07 MPa, or -0.08 MPa).

[0027] In some embodiments of the present invention, filtration is required before the enzyme inactivation treatment. The filtration is performed using a 100-250 mesh filter. For example, the mesh size of the filter can be 100, 115, 120, 125, 130, 140, 150, 160, 170, 175, 180, 200, 230, 240, or 250.

[0028] In some embodiments of the present invention, in step (2), the solid-liquid separation includes at least one of filtration and centrifugation.

[0029] In some embodiments of the present invention, step (2) further includes a third concentration treatment of the liquid phase after solid-liquid separation. The third concentration treatment concentrates the liquid phase to a relative density of 1.2 g / cm³. 3 -1.3 g / cm 3 (Measured at 65℃). For example: it can be 1.2 g / cm³. 3 1.21 g / cm 3 1.22 g / cm 3 1.23 g / cm 3 1.24 g / cm 3 1.25g / cm 3 1.26 g / cm 3 1.27 g / cm3 1.28 g / cm 3 1.29 g / cm 3 Or 1.30 g / cm 3 .

[0030] In some embodiments of the present invention, the third concentration process is vacuum concentration. The temperature of the vacuum concentration is 65°C to 75°C (e.g., 65°C, 66°C, 67°C, 68°C, 69°C, 70°C, 71°C, 72°C, 73°C, 74°C, or 75°C). The vacuum degree of the vacuum concentration is -0.04 MPa to -0.08 MPa (e.g., -0.04 MPa, -0.05 MPa, -0.06 MPa, -0.07 MPa, or -0.08 MPa).

[0031] In some embodiments of the present invention, the relative density of the herbal extract is 1.2 g / cm³. 3 -1.3 g / cm 3 (Measured at 65℃). For example: it can be 1.2 g / cm³. 3 1.21 g / cm 3 1.22 g / cm 3 1.23 g / cm 3 1.24 g / cm 3 1.25g / cm 3 1.26 g / cm 3 1.27 g / cm 3 1.28 g / cm 3 1.29 g / cm 3 Or 1.30 g / cm 3

[0032] In another aspect, the present invention provides a method for preparing the composition described in the first aspect, comprising the following steps:

[0033] The coffee raw material and the herbal extract are mixed to obtain the composition.

[0034] In another aspect, the present invention provides an formulation comprising the composition described in the first aspect.

[0035] In some embodiments of the present invention, the pH of the preparation is 6-6.5. For example, it can be 6, 6.1, 6.2, 6.3, 6.4 or 6.5.

[0036] In some embodiments of the present invention, the formulation further includes other pharmaceutically or food-grade excipients. These excipients include at least one selected from pH adjusters, dietary fiber, sweeteners, acidulants, and antioxidants.

[0037] In some embodiments of the present invention, the pH adjuster includes at least one of dipotassium hydrogen phosphate, sodium bicarbonate, sodium carbonate, sodium pyrophosphate, disodium hydrogen phosphate, calcium hydrogen phosphate, and sodium citrate.

[0038] In some embodiments of the present invention, the dietary fiber includes at least one of polydextrose, inulin, and resistant dextrin.

[0039] In some embodiments of the present invention, the dietary fiber includes at least one of polydextrose, inulin, and resistant dextrin.

[0040] In some embodiments of the present invention, the sweetener includes at least one of granulated sugar, fructose syrup, maltose, sucralose, and steviol glycosides.

[0041] In some embodiments of the present invention, the acidulant includes at least one of citric acid and lactic acid.

[0042] In some embodiments of the present invention, the antioxidant includes at least one of vitamin C, vitamin E, tea polyphenols, grape seed extract, and sodium lactate.

[0043] In some embodiments of the present invention, the composition comprises, by weight, 1700-2000 parts coffee raw material, herbal extract, and 80-120 parts dietary fiber; the raw materials for preparing the herbal extract include 50-60 parts green tea, 35-45 parts bitter melon, 30-35 parts licorice, 30-35 parts cassia seed, and 35-45 parts lotus leaf.

[0044] In some embodiments of the present invention, the composition comprises, by weight, 1850-1900 parts coffee raw material, herbal extract, and 90-110 parts dietary fiber; the raw materials for preparing the herbal extract include 52-56 parts green tea, 38-42 parts bitter melon, 31-35 parts licorice, 31-35 parts cassia seed, and 38-42 parts lotus leaf.

[0045] In some embodiments of the present invention, the composition comprises, by weight, 1875 parts coffee raw material, herbal extract, and 100 parts dietary fiber; the raw materials for preparing the herbal extract include 54 parts green tea, 40 parts bitter melon, 33 parts licorice, 33 parts cassia seed, and 40 parts lotus leaf.

[0046] In some embodiments of the present invention, the formulation further includes a solvent. The solvent is water.

[0047] In some embodiments of the present invention, the dosage form of the preparation is selected from powders, granules, pills, tablets, capsules, powders, oral liquids, and beverages. The composition obtained by the present invention can be presented in the form of an extract, which can be further formulated into the above-mentioned dosage forms through conventional formulation processes. This allows patients to choose a dosage form suitable for daily carrying and consumption according to their own needs. For example, the formulation process of an oral liquid may include the following steps: mixing the composition extract, excipients, and solvent together in a certain proportion, fully dissolving, and filtering to obtain the final product.

[0048] In another aspect, the present invention provides the use of the above-described composition or formulation in the preparation of products for weight loss or inhibition of fat absorption.

[0049] In some embodiments of the present invention, the product is a drug.

[0050] In some embodiments of the present invention, the weight loss is manifested as at least one of the following: reducing body weight, reducing BMI index, reducing waist circumference, reducing hip circumference, reducing BMI index, abdominal fat thickness, and reducing unhealthy eating behaviors.

[0051] The present invention has at least the following beneficial effects:

[0052] The composition of the present invention has good stability, can effectively inhibit fat absorption, and has a good weight loss effect, which can reduce weight, BMI index, waist circumference, hip circumference, abdominal fat thickness and bad eating behavior. Attached Figure Description

[0053] Figure 1 Typical images of the fat content in the intestines and tail blood vessels of zebrafish in each group of test example 1; the yellow dashed boxes indicate the areas analyzed. Detailed Implementation

[0054] The following will describe the concept and technical effects of the present invention clearly and completely with reference to embodiments, so as to fully understand the purpose, features and effects of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are all within the scope of protection of the present invention.

[0055] In the description of this invention, the use of terms such as first, second, third, etc., is only for the purpose of distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of technical features indicated, or implicitly indicating the order of the technical features indicated.

[0056] When a numerical range is disclosed herein, the range is considered continuous and includes the minimum and maximum values ​​of the range, as well as every value between the minimum and maximum values. Furthermore, when the range refers to integers, it includes every integer between the minimum and maximum values ​​of the range. Additionally, when multiple ranges are provided to describe a feature or characteristic, the ranges may be combined. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges to which they are incorporated.

[0057] "Parts by mass" refers to the basic unit of measurement that expresses the mass ratio of multiple components. One part can represent any unit mass, such as 1g or 2.689g. If we say that component A has "a" parts by mass and component B has "b" parts by mass, it means the ratio of the mass of component A to the mass of component B is a:b. Alternatively, it can mean that the mass of component A is aK and the mass of component B is bK (where K is any number representing a multiplier). It is important to understand that, unlike mass fractions, the sum of the mass parts of all components is not limited to 100 parts.

[0058] "And / or" is used to indicate that one or both of the described situations may occur, for example, A and / or B includes (A and B) and (A or B).

[0059] Unless otherwise specified, "about" in this invention means that the allowable error is within ±2%.

[0060] Unless otherwise specified, "room temperature" or "normal temperature" in this invention means (25±5)℃.

[0061] In the following examples, green tea (polyphenol content ≥30wt%) was purchased from Yunnan Baiyao Tianyi Tea Products Co., Ltd., and bitter melon, licorice, cassia seed, and lotus leaf were purchased from Yunnan Baiyao Group Wenshan Qihua Co., Ltd.; all the above medicinal materials met the standards of the National Pharmacopoeia. Cellulase SPE-017L, pectinase SAM-027, cellobiase HL, and tanninase 10FG were all purchased from Sandeyuan Trading Co., Ltd. Coffee concentrate (soluble solids content 11±1wt% (GB / T 12143), caffeine (alkali) content 0.362wt% (GB / T 5009.139-2014)) was purchased from Damin Biotechnology (Zhangzhou) Co., Ltd. Polydextrose (90% liquid), dipotassium hydrogen phosphate, and sodium bicarbonate were purchased from Yunnan Haoliao Trading Co., Ltd.

[0062] Example 1

[0063] This embodiment provides a composition comprising herbal extracts, coffee concentrate, polydextrose, and pH adjusters (dipotassium hydrogen phosphate and sodium bicarbonate); the raw materials for preparing the herbal extracts are green tea, bitter melon, licorice, cassia seed, and lotus leaf. Under these conditions, the composition can be stably stored for 9-18 minutes without precipitation or flocculation.

[0064] This embodiment also provides a method for preparing the above composition, which includes the following steps:

[0065] S1. Preparation of herbal extracts.

[0066] (1) Weigh 54 kg of green tea, 40 kg of bitter melon, 33 kg of licorice root, 33 kg of cassia seed, and 40 kg of lotus leaf. Add 12 times the weight of the herbs in water, heat to boiling for 2 hours, and filter through a 200-mesh filter. Add 10 times the weight of the herbs in water a second time, heat to boiling for 2 hours, and filter through a 200-mesh filter. Add 10 times the weight of the herbs in water a third time, heat to boiling for 1 hour. Combine the three filtrates and transfer them to an evaporator. Concentrate the filtrates at a temperature of 65℃~75℃ and a vacuum of -0.04 MPa~-0.08 MPa until the relative density is approximately 1.05 g / cm³. 3 (Measured at 60-75℃), the concentrated solution was obtained.

[0067] (2) Transfer the concentrate to a thermos, set the temperature to 40℃, and add 1.5wt‰ cellulase, 1.5wt‰ pectinase, 1.5wt‰ cellobiase, and 1.5wt‰ tanninase based on the weight of the concentrate. Stir and incubate for 4 hours for enzymatic hydrolysis, then let it sit overnight for 10 hours. Filter through a 200-mesh filter and boil for 30 minutes to inactivate the enzymes. Transfer the hydrolysate to a concentration tank and concentrate it to a relative density of approximately 1.10 g / cm³ under conditions of 65℃~75℃ and a vacuum of -0.04 MPa~-0.08 MPa. 3 (Measured at 60-75℃), after passing through a 200-mesh filter cloth, the sample was centrifuged at 16,000 rpm using a high-speed tubular centrifuge at room temperature to obtain the supernatant. The supernatant was then transferred to an external circulation vacuum concentrator for concentration (concentration temperature 65℃~75℃, pressure -0.04 MPa~-0.08 MPa) until the relative density was approximately 1.2-1.3 g / cm³. 3 (Measured at 60-75℃) to obtain an extract (i.e., herbal extract).

[0068] S2. Add the herbal extract obtained in S1, 1875 kg of coffee concentrate, and 100 kg of polydextrose to a mixing container. Add purified water to a final volume of 2500 L and stir continuously for 5-10 min to ensure complete dissolution of all components and form a homogeneous and stable mixed solution. Add 2.5 kg of sodium bicarbonate and 3.75 kg of dipotassium hydrogen phosphate to the mixed solution to adjust the pH to 6.2 ± 0.1. Transfer the solution to a storage tank and treat it with compressed air at room temperature for 1 h. Then, pump the solution into a filtration system (microporous filter cartridge with a pore size of 0.5 μm) for pressurized circulation filtration for 30 min to ensure the removal of small particulate impurities and insoluble substances, obtaining a clear and transparent filtrate. Pack the filtrate into packaging bags (25 mL / bag) and sterilize them in a vacuum sterilizer at high temperature (100℃ for 20 min).

[0069] Comparative Example 1

[0070] This comparative example provides a composition that is essentially the same as that in Example 1, except that the preparation method of the herbal extract differs. Specifically, it excludes the tanninase in step (2) of the preparation method of the herbal extract in Example 1. Under these conditions, the composition can only be stored stably for 3-4 weeks without precipitation, flocculation, or other phenomena.

[0071] When the herbal extract prepared in this example is left to stand at room temperature, a significant precipitate will form within a short period of time, with a much larger amount of precipitate than that of the herbal extract in Example 1. Furthermore, the herbal extract in Example 1 has a higher retention of active substances and better stability, while the herbal extract in this example is prone to component polymerization and precipitation, resulting in weaker overall quality and activity.

[0072] Comparative Example 2

[0073] This comparative example provides a composition that is essentially the same as that in Example 1, except that the preparation method of the herbal extract is different. Specifically, the pectinase in step (2) of the preparation method of the herbal extract in Example 1 is replaced with an equal mass of glucanase. Under these conditions, the composition can be stably stored for only 3-7 days without precipitation or flocculation.

[0074] When the herbal extract prepared in this example is left to stand at room temperature, a significant precipitate forms within a short period, exhibiting a gel-like consistency. The amount of precipitate is far greater than that of the herbal extract in Example 1. Furthermore, the colloidal decomposition of the herbal extract in this example is incomplete, with large-molecule polysaccharides and gelatinous substances easily agglomerating and precipitating, resulting in decreased system stability and a lower retention of functional active ingredients compared to Example 1.

[0075] Test Example 1

[0076] This test case investigated the efficacy of the composition of Example 1 in inhibiting fat absorption.

[0077] Zebrafish were raised in aquarium water at 28℃ (water quality: 200 mg of readily soluble sea salt added per 1 L of reverse osmosis water, conductivity 450~550 μS / cm; pH 6.5~8.5; hardness 50~100 mg / L CaCO3), laboratory animal use license number: SYXK (Zhejiang) 2022-0004, husbandry and management met the requirements of international AAALAC certification (certification number: 001458), IACUC ethics review number: IACUC-2026-202603130006-01.

[0078] Zebrafish (albino) with a melanin allele mutation, 5 days post-fertilization (5 dpf), were randomly selected and placed in beakers, with 30 zebrafish treated in each beaker. The experimental groups were given the water-soluble composition from Example 1 (concentrations set at 0.977 μL / mL, 1.95 μL / mL, 3.91 μL / mL, and 7.81 μL / mL, respectively), while the positive control group was given water-soluble orlistat (batch number 085240702, Shandong New Era Pharmaceutical Co., Ltd.; concentration 15.0 μg / mL). Normal control and model control groups were also set up. Each beaker had a volume of 20 mL. After treatment at 28℃ for 1 h, except for the normal control group, all other groups were fed water-soluble egg yolk powder (batch number 20260201, Zhejiang Aige Biotechnology Co., Ltd.) to establish a dietary fat absorption model. After further treatment at 28℃ for 29 h, samples were collected and stained with Oil Red O for overall fat staining. After destaining, 10 zebrafish from each group were randomly selected and photographed under a dissecting microscope. Data were collected using NIS-Elements D 3.20 advanced image processing software to analyze the fat content in the intestines and tail vessels. The statistical analysis results of this index were used to evaluate the efficacy of the samples in inhibiting fat absorption. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software, and p < 0.05 indicated statistical significance.

[0079]

[0080] Note: Compared with the model control group, *** p < 0.001.

[0081] No zebrafish died in any of the groups, and no obvious abnormalities were observed.

[0082] As shown in Table 1 and Figure 1 As shown. The composition of Example 1 has the effect of inhibiting fat absorption, specifically by reducing the fat content in the blood vessels of the intestine and tail.

[0083] Test Example 2

[0084] This test case examines the effectiveness and safety of the composition of Example 1 in weight loss.

[0085] The specific methods used are as follows:

[0086] Twenty-two overweight or mildly obese volunteers were recruited. General demographic information is shown in Table 2. Exclusion criteria for volunteers were: (1) those with serious diseases of the heart, liver, kidneys, and hematopoietic system, or those with mental illness. (2) those who had taken any drugs related to the function being tested within the past month. (3) those who were allergic to any component of the test product. (4) pregnant women, women planning to become pregnant, or women who were breastfeeding. (5) those who had participated in or were currently participating in other clinical studies within the past three months. (6) those who were deemed unsuitable to participate in this trial or were likely to be lost to follow-up.

[0087]

[0088] Each participant took one packet of the composition from Example 1 twice per administration, either directly or diluted with water. The trial period was 4 weeks, with 2 follow-ups. Evaluation was based on efficacy indicators before and after the trial, including weight (electronic scale), height (height measuring tape), BMI, waist circumference, hip circumference, waist-to-hip ratio (measurement tape), abdominal fat thickness (fat clamp), and appetite status (Chinese version of the Dutch Eating Behavior Questionnaire (DEBQ)). Data analysis was performed using R4.5.1 software. Quantitative data conformed to a normal distribution and were expressed as mean ± standard deviation (s). Paired t-tests or rank-sum tests were used to analyze the differences between baseline and follow-up values ​​for each parameter.

[0089]

[0090] Note: The DEBQ scale is mainly used to quantitatively assess three dimensions of eating behavior in a population: restrictive eating, emotional eating, and external eating. The higher the total score of the questionnaire, the weaker the individual's ability to control eating, the more obvious the eating behavior driven by emotions and external factors, and the higher the tendency to binge eat and overeat.

[0091] During the trial period, no adverse gastrointestinal reactions or allergic reactions occurred in any of the volunteers. Compared with the baseline (D0), after 28 days of continuous consumption (D28), the subjects' weight, BMI, waist circumference, hip circumference, abdominal fat thickness, and poor eating behavior (appetite) all decreased to varying degrees. Among them, weight and BMI decreased significantly compared with the baseline level, and the differences within the group were statistically significant (P < 0.001). This indicates that continuous consumption of the composition of Example 1 for 28 days can effectively improve the weight and BMI levels of overweight and obese individuals, and also has a certain positive regulatory effect on body shape-related indicators and poor eating behavior, with good safety.

[0092] The embodiments of the present invention have been described in detail above with reference to the examples. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention. Furthermore, the embodiments of the present invention and the features thereof can be combined with each other unless otherwise specified.

Claims

1. A composition, characterized in that, The composition comprises the following components: coffee raw material and herbal extracts; The raw materials for preparing the herbal extract include green tea, bitter melon, licorice, cassia seed, and lotus leaf; the preparation method of the herbal extract includes the following steps: (1) The raw materials are mixed according to the specified ratio and extracted with water to obtain an extract; (2) The extract is subjected to enzymatic hydrolysis by cellulase, pectinase, cellobiase and tanninase, and solid-liquid separation is performed. The liquid phase is the herbal extract.

2. The composition according to claim 1, characterized in that, By weight, the composition comprises 1700-2000 parts of coffee raw material and herbal extract; the raw materials for preparing the herbal extract include 50-60 parts of green tea, 35-45 parts of bitter melon, 30-35 parts of licorice, 30-35 parts of cassia seed, and 35-45 parts of lotus leaf; preferably, the composition comprises 1850-1900 parts of coffee raw material and herbal extract; the raw materials for preparing the herbal extract include 52-56 parts of green tea, 38-42 parts of bitter melon, 31-35 parts of licorice, 31-35 parts of cassia seed, and 38-42 parts of lotus leaf.

3. The composition according to claim 1, characterized in that, In step (1), the extraction process includes: adding water in amounts of 6 to 13 times the total mass of the raw materials each time, heating and boiling, and obtaining the extract through solid-liquid separation.

4. The composition according to claim 1, characterized in that, In step (2), the amount of cellulase, pectinase, cellobiase and / or tanninase used is 1wt‰-2wt‰ of the mass of the extract; and / or, the enzymatic hydrolysis time is 4 h-16 h; and / or, the enzymatic hydrolysis temperature is 40℃-55℃.

5. The composition according to claim 1, characterized in that, The soluble solids content of the coffee raw material is not less than 9 wt%; and / or, the caffeine (alkali) content of the coffee raw material is not less than 0.2 wt%.

6. A method for preparing the composition according to claims 1 to 5, characterized in that, The process includes the following steps: mixing the coffee raw material and the herbal extract to obtain the composition.

7. A formulation, characterized in that, Includes the compositions according to claims 1 to 5.

8. The formulation as described in claim 7, characterized in that, The formulation may also include other pharmaceutically or food-acceptable excipients; preferably, the excipients include at least one of pH adjusters, dietary fiber, sweeteners, acidulants, and antioxidants.

9. The formulation as described in claim 8, characterized in that, The pH adjuster includes at least one of dipotassium hydrogen phosphate, sodium bicarbonate, sodium carbonate, sodium pyrophosphate, disodium hydrogen phosphate, calcium hydrogen phosphate, and sodium citrate; and / or, the dietary fiber includes at least one of polydextrose, inulin, and resistant dextrin; and / or, the dietary fiber includes at least one of polydextrose, inulin, and resistant dextrin; and / or, the sweetener includes at least one of white sugar, fructose syrup, maltose, sucralose, and steviol glycosides; and / or, the acidulant includes at least one of citric acid and lactic acid; and / or, the antioxidant includes at least one of vitamin C, vitamin E, tea polyphenols, grape seed extract, and sodium lactate.

10. Use of the composition of claims 1 to 5 or the formulation of any one of claims 7 to 9 in the preparation of a product for weight loss or inhibition of fat absorption.

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