Hydrogel material composition, and weight management composition, preparation method therefor and use thereof

By combining konjac flour, galactomannan, and resistant dextrin, the shortcomings of existing weight management compositions in terms of formulation and fat absorption are overcome, achieving good formulation performance and fat intervention effect. This makes it suitable for large-scale development and use, promoting weight management and health control.

WO2025223437A1PCT designated stage Publication Date: 2025-10-30SHANGHAI SCIZENG MEDICAL TECH CO LTD

Patent Information

Application Number
PCT/CN2025/090564
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-04-25
Filing Date
2025-04-23
Publication Date
2025-10-30

AI Technical Summary

Technical Problem

Existing weight management compositions cannot simultaneously achieve good tableting performance, disintegration performance, and lipid absorption intervention at the formulation level, and they also have side effects, making large-scale development difficult and resulting in poor user tolerance.

Method used

A weight management composition is prepared by mixing konjac flour, galactomannan, and resistant dextrin in a specific ratio. Disintegrants, fillers, and lubricants are added to form a hydrogel material with gastric volume-occupying and fat absorption-intervention functions.

Benefits of technology

It achieves good formulation performance, disintegration performance and lipid absorption intervention effect, with stable product quality, suitable for large-scale application, can occupy space in the stomach, promote satiety, reduce appetite, and achieve the purpose of weight management and health control.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to the technical field of food and drugs, and in particular to a hydrogel material composition, and a weight management composition, a preparation method therefor and a use thereof. The hydrogel material composition comprises konjac powder, galactomannan, and resistant dextrin. The weight management composition comprises the following components in parts by mass: 40-60 parts of a hydrogel material composition, 10-40 parts of a disintegrating agent, 0-15 parts of inorganic salt, and 10-35 parts of a filler. In the present invention, the composition prepared from specific components and by specific proportions can have good preparation performance, disintegration performance, and gelling performance; the product quality stability is high; the composition is suitable for large-scale application development; and the composition can occupy the space in the stomach after being eaten, so that satiety is promoted, and the appetite is reduced, thereby achieving the purposes of realizing weight management, blood sugar control and the like.
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Description

Hydrogel material compositions, weight management compositions, their preparation methods and applications

[0001] Cross-references

[0002] This application claims priority to Chinese Patent Application No. 2024105078383, filed on April 25, 2024, entitled “Hydrogel Material Composition, Weight Management Composition and Preparation Method Thereof and Application”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to the field of food and pharmaceutical technology, and in particular to a hydrogel material composition, a weight management composition, its preparation method and application. Background Technology

[0004] With the development of social productivity and the economy, people's living standards have continuously improved, and the proliferation of commercial and social occasions has led to ample food intake, including high-fat, high-oil, and alcohol consumption, resulting in problems such as overweight, obesity, and type 2 diabetes. Overweight and obesity are caused by energy intake exceeding the body's energy expenditure, and weight loss can be achieved by reducing total calorie intake from food or by reducing calorie intake from specific dietary components. Lifestyle changes are difficult to alter, and related interventions are easily influenced by external factors. Therefore, many researchers have conducted research on the development of drugs and substances to promote weight control or weight loss. Currently, FDA-approved anti-obesity drugs include Orlistat, Liraglutide, and Semaglutide. While these drugs are effective, they may have side effects such as diarrhea and abdominal pain, require a doctor's prescription, and have shortcomings in terms of safety and accessibility.

[0005] In recent years, weight-loss compositions designed to promote or induce satiety or reduce hunger, thereby reducing food intake, have gained popularity. These compositions swell in the stomach, occupying space and providing a prolonged feeling of fullness, thus suppressing appetite and controlling weight. As a simple weight management method, users take it before their main meals to create a feeling of fullness and reduce food intake. Compared to weight-loss drugs and devices, it offers natural advantages in convenience and tolerability. Screening for polysaccharides and other ingredients with good swelling properties from food allows for attention to efficacy while ensuring safety.

[0006] Many substances, due to their structural characteristics, excel in certain functions but suffer from shortcomings in others. For example, some polysaccharides readily adsorb with water but easily form hydration films and clumps, resulting in insufficient swelling and reduced gastric volume. Furthermore, from a finished product perspective, these raw materials require feasibility at the formulation level. Taking tablets as an example, in practical applications, the tableting process after mixing multiple excipients easily leads to powder agglomeration and poor flowability, making complete disintegration in vivo difficult. If high tableting performance is required, the resulting tablets will also have high hardness, typically resulting in unsatisfactory disintegration and gelation properties in vivo. Conversely, if the requirements for tableting hardness are lowered, product quality and stability are difficult to guarantee; both are difficult to achieve simultaneously.

[0007] In addition, due to the diversity of food combinations, besides simply reducing intake by increasing stomach volume, whether it has an absorption-intervention effect on other food components such as oils is also an important aspect of improving product efficacy.

[0008] There is an urgent need to develop a composition that possesses good tableting performance, good disintegration and swelling gelation properties, lipid absorption intervention properties, simple preparation method, suitability for large-scale development, good efficacy, and good user tolerance, which can be used for weight management.

[0009] In view of this, the present invention is hereby proposed. Summary of the Invention

[0010] To address the aforementioned technical problems, this invention provides a hydrogel material composition, a weight management composition, a preparation method thereof, and its application.

[0011] Specifically, the technical solution of the present invention is as follows:

[0012] In a first aspect, the present invention provides a hydrogel material composition comprising konjac flour, galactomannan, and resistant dextrin.

[0013] Preferably, the combination ratio of konjac powder, galactomannan, and resistant dextrin is 35-55 parts by weight of konjac powder, 0.5-10 parts by weight of resistant dextrin, and 1-10 parts by weight of galactomannan.

[0014] Preferably, the mass fraction of the konjac powder can be selected from any two values ​​within the range of 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54 and 55.

[0015] The mass fraction of the resistant dextrin can be selected from any two values ​​within the range of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10.

[0016] The mass fraction of the galactomannan can be selected from any two values ​​in the range of 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10.

[0017] Optionally, the bulk hydrogel material composition comprises 42-48 parts konjac flour, 0.5-10 parts resistant dextrin, and 1-3 parts galactomannan.

[0018] Optionally, the hydrogel material composition comprises 42-48 parts konjac flour, 0.5-5 parts resistant dextrin, and 1-3 parts galactomannan.

[0019] Optionally, the hydrogel material composition comprises 42-48 parts konjac flour, 0.5-2.5 parts resistant dextrin, and 1-3 parts galactomannan.

[0020] Optionally, the hydrogel material composition comprises 42.2 parts konjac flour, 10 parts resistant dextrin, and 2 parts galactomannan.

[0021] Optionally, the hydrogel material composition comprises 45 parts konjac flour, 1 part resistant dextrin, and 2 parts galactomannan.

[0022] The present invention does not impose any particular limitation on the source of each component; any commercially available product in the art is acceptable.

[0023] In a more specific embodiment of the present invention, the konjac powder, also known as konjac gum, refers to konjac powder that conforms to the standards of QB494-2012 or NY / T494-2010, such as ordinary konjac powder, ordinary konjac refined powder, ordinary konjac micro powder, purified konjac powder, purified konjac refined powder, purified konjac micro powder, etc. As one more specific embodiment, the glucomannan content of the konjac powder can be 60%, 70%, 80% or more, or it can be pure glucomannan.

[0024] Galactomannan is derived from guar beans. Guar beans originated in India and Pakistan, where they have been consumed for a long time and are known locally as "beans that won't make you fat." The core component of guar beans is galactomannan, composed of mannose and galactose. It has thickening and gelling properties, while also improving viscosity, water retention, regulating gut microbiota, and promoting gut health.

[0025] In a more specific embodiment of the present invention, the resistant dextrin is preferably derived from corn starch, which contains a variety of glycosidic bonds in its molecular structure and has an average molecular weight of 1500-3000, for example, an average molecular weight of 2000.

[0026] Preferably, the konjac flour has a glucomannan content of over 70%; the galactomannan is derived from guar beans; and the resistant dextrin is derived from corn starch.

[0027] In a second aspect, the present invention provides a weight management composition comprising the following components in parts by weight: 40-60 parts of the aforementioned hydrogel material composition (containing 35-55 parts of konjac flour, 0.5-10 parts of resistant dextrin and 1-10 parts of galactomannan), 10-40 parts of disintegrant, 0-15 parts of inorganic salt, and 10-35 parts of filler.

[0028] Preferably, the weight management composition further includes 0.2-2 parts of lubricant.

[0029] Preferably, the inorganic salt is a monovalent or divalent cation salt, such as a potassium salt, sodium salt, or calcium salt; preferably sodium bicarbonate, calcium carbonate, or a combination thereof, or no inorganic salt is added.

[0030] Preferably, the filler is selected from at least one of fructooligosaccharides, sugar alcohols, starch, sucrose, lactose, and dextrin;

[0031] Preferably, the filler is selected from sugar alcohols and / or fructooligosaccharides. Preferably, the sugar alcohol is at least one selected from sorbitol, mannitol, erythritol, maltitol, lactitol, and xylitol; sorbitol is preferred.

[0032] Preferably, the disintegrant is selected from at least one of microcrystalline cellulose, low-substituted hydroxypropyl cellulose (with a degree of substitution of 5.0%-16.0%), sodium carboxymethyl starch, croscarmellose, and croscarmellose sodium; preferably, it is microcrystalline cellulose.

[0033] Preferably, the lubricant is selected from at least one of magnesium stearate, micronized silica gel, talc, magnesium lauryl sulfate, polyethylene glycol 4000, and polyethylene glycol 6000.

[0034] In addition, the weight management composition provided by the present invention may optionally include a flavoring agent as needed. The flavoring agent may be at least one of sodium saccharin, sucralose, mogroside, or steviol glycoside. In a specific embodiment of the present invention, the flavoring agent is mogroside, and the amount used is 0.005%-0.02% of the total weight of the weight management composition.

[0035] The present invention does not impose any particular limitation on the source of each component; any commercially available product in the art is acceptable.

[0036] In the weight management composition provided by this invention: a filler (especially a sugar alcohol) serves as a carrier; the hydrogel material functions to generate an expandable, viscous, and indigestible hydrogel in the stomach, thereby increasing satiety. A disintegrant (especially microcrystalline cellulose) promotes the disintegration of the solid composition in the stomach upon entry, resulting in the formation of dispersed hydrogel particles and enhancing the swelling effect.

[0037] Further, in this invention, the weight management composition preferably comprises 35-55 parts konjac flour, 0.5-10 parts resistant dextrin, 1-10 parts galactomannan, 0-15 parts sodium bicarbonate, 15-30 parts sorbitol, 10-35 parts microcrystalline cellulose, 0-20 parts croscarmellose sodium, 0-1 part lubricant, 0-0.3 parts calcium carbonate, and 0-0.05 parts flavoring agent. Wherein:

[0038] The mass fraction of the konjac powder can be selected from any two values ​​within the range of 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54 and 55.

[0039] The mass fraction of the resistant dextrin can be selected from any two values ​​within the range of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10.

[0040] The mass fraction of the galactomannan can be selected from any two values ​​in the range of 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10.

[0041] The mass fraction of sodium bicarbonate can be selected from any two values ​​within the range of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15.

[0042] The mass fraction of sorbitol can be selected from any two values ​​within the range of 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30.

[0043] The mass fraction of the microcrystalline cellulose can be selected from any two values ​​within the range of 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 and 35.

[0044] The mass fractions of the crosslinked carboxymethyl cellulose sodium can be selected from any two values ​​within the range of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20.

[0045] The mass fraction of the lubricant can be selected from any two values ​​in the range of 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 and 1.0, for example, magnesium stearate.

[0046] The mass fraction of calcium carbonate can be selected from any two values ​​within the range of 0, 0.02, 0.05, 0.07, 0.10, 0.13, 0.15, 0.18, 0.20, 0.25, and 0.30.

[0047] The mass fraction of the flavoring agent can be selected from any two values ​​within the range of 0, 0.005, 0.010, 0.015, 0.020, 0.030, 0.040 and 0.050, such as mogroside.

[0048] Optionally, the weight management composition comprises 42-48 parts konjac flour, 1-10 parts resistant dextrin, 1-3 parts galactomannan, 0-10 parts sodium bicarbonate, 20-24 parts sorbitol, 14-32 parts microcrystalline cellulose, 0-15 parts croscarmellose sodium, 0-0.7 parts lubricant, 0-0.2 parts calcium carbonate, and 0-0.05 parts flavoring agent.

[0049] Optionally, the weight management composition comprises 42-48 parts konjac flour, 1-5 parts resistant dextrin, 1-3 parts galactomannan, 20-24 parts sorbitol, 25-32 parts microcrystalline cellulose, 0-0.4 parts lubricant, and 0-0.05 parts flavoring agent.

[0050] Optionally, the weight management composition comprises 42-48 parts konjac flour, 0.5-2.5 parts resistant dextrin, 1-3 parts galactomannan, 18-22 parts sorbitol, 30-32 parts microcrystalline cellulose, 0.3-0.5 parts lubricant, and 0-0.05 parts flavoring agent.

[0051] Optionally, the weight management composition comprises 45 parts konjac flour, 1 part resistant dextrin, 2 parts galactomannan, 20 parts sorbitol, 31.6 parts microcrystalline cellulose, 0.39 parts lubricant, and optionally 0-0.05 parts flavoring agent; for example, 0.01 parts mogroside.

[0052] The choice of the above-mentioned lubricants and flavoring agents has little impact on the performance of the weight management composition. For example, the lubricants used are magnesium stearate, talc, polyethylene glycol (PEG) 4000 or 6000, and the flavoring agents used are mogrosides.

[0053] The weight management composition of this invention can be formulated into commonly used solid dosage forms such as tablets, capsules, powders, granules, or lozenges. The weight management composition can be a pharmaceutical, food, health product, health food, candy, dietary supplement, meal replacement, or food additive.

[0054] The raw materials of the weight management composition product provided by this invention are safe and healthy, and have no toxic side effects on the human body; the components work together in a scientific and reasonable manner, can play a synergistic role, and are easy to prepare for subsequent products.

[0055] Thirdly, the present invention provides a method for preparing the weight management composition, comprising the following steps: mixing hydrogel materials to obtain a premix; then mixing the premix with other components and compressing it into tablets.

[0056] Fourthly, the present invention provides the use of the hydrogel material composition or weight management composition in the preparation of a drug or food related to human weight or health, wherein the drug or food related to human weight or health is used to achieve the following purposes: weight loss, obesity prevention and treatment, weight management, reduction of calorie intake, reduction of appetite, promotion of satiety, adjunctive prevention and treatment of diabetes, control of blood sugar, reduction of fat absorption, reduction of blood cholesterol, relief or treatment of constipation, etc.

[0057] The present invention also provides the following uses for the hydrogel material composition or weight management composition as described above: weight loss, obesity prevention and treatment, weight management, reducing calorie intake, reducing appetite, promoting satiety, assisting in the prevention and treatment of diabetes, controlling blood sugar, reducing fat absorption, reducing blood cholesterol, relieving or treating constipation, etc. Beneficial effects:

[0058] This invention provides a hydrogel material composition that possesses gastric volume-filling properties and delays gastric emptying, while also exhibiting a novel function of adsorbing / encapsulating oils. The weight management composition of this invention, containing this hydrogel material composition, prepared through specific component ratios, simultaneously possesses excellent formulation properties, disintegration properties, and gelling properties. The product exhibits high quality stability, making it suitable for large-scale application development. After consumption, it occupies gastric space, promoting satiety and reducing appetite, thereby achieving the goals of weight management and blood sugar control. Attached Figure Description

[0059] To more clearly illustrate the technical solutions in this invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be described below.

[0060] Figure 1 shows the curve of the change in the mass of gastric contents with digestion time in the dynamic in vitro gastric digestion experiment of Experiment Example 3 of the present invention.

[0061] Figure 2 shows the curve of gastric residue rate changing with digestion time in the dynamic in vitro gastric digestion experiment of Experiment Example 3 of the present invention. Detailed Implementation

[0062] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention. Unless otherwise specified, the experimental methods used in the embodiments are all conventional methods; the materials and reagents used are all commercially available.

[0063] Unless otherwise stated, "parts" in the following examples refer to parts by weight.

[0064] The types and specifications of some of the raw materials used in the examples and comparative examples are shown in Table 1 below:

[0065] Table 1

[0066] Examples 1-9

[0067] Examples 1-9 each provide a solid composition for weight management, the formulation of which (unit: g) is shown in Table 2:

[0068] Table 2

[0069] The preparation methods of the solid compositions for weight management provided in Examples 1-9 are as follows:

[0070] (1) Mix the hydrogel material evenly for 30 minutes using a mixer to obtain a premix;

[0071] (2) Take the premix obtained in step (1) above and mix it with other components in a mixer for 30 minutes to obtain the final mixture;

[0072] (3) Take the final mixture obtained in step (2) above and compress it into tablets using a tablet press to obtain tablets of 0.6g / tablet.

[0073] Experimental Example 1

[0074] This experimental example tests the tableting performance (tablet hardness), disintegration performance, and gelling state of the compositions provided in Examples 1-9. The specific methods are as follows:

[0075] (1) The hardness of the tablets was tested using a hardness tester, Guoyao Longli Z10.

[0076] (2) The tablets of this invention are designed as slow-disintegrating products, expected to achieve complete disintegration within 10 minutes. The disintegration performance test method is as follows: The tablet is placed in 100ml of a mixture (80ml water + 20ml simulated gastric juice), and tested 3 times (tested at 37℃, and the average of the 3 tests is taken). After 10 minutes, the undisintegrated lumps are removed, the surface gel is scraped off, and M1 is weighed. Disintegration degree = M1 / ​​total mass of a single tablet * 100%. The scoring criteria are as follows:

[0077] 1: Completely non-disintegrating state;

[0078] 2: Slight disintegration, 10% ≤ disintegration < 50%, tablets are clearly clumpy;

[0079] 3: Disintegration degree ≥ 50%, with obvious lumps still present;

[0080] 4. It can completely disintegrate, and the disintegration time is ≥10min;

[0081] 5: It can completely disintegrate, and the disintegration time is <10min.

[0082] (3) The gelation state test method is as follows: Place the tablets into 100ml of a mixture (80ml water + 20ml simulated gastric juice, 37℃). The scoring criteria are as follows:

[0083] 1. No visible viscous gel-like clumps; water absorption rate ≤ 2 times.

[0084] 2: The solution contains a small amount of viscous gel-like clumps, with a water absorption rate of 2 times < to 10 times (water absorption rate = gel mass / tablet weight);

[0085] 3: The solution contains large, viscous gel-like clumps, with a water absorption rate of 10 times < to 20 times, and significant free water.

[0086] 4: Large, viscous gel-like masses can form in the solution. There is no free water, but there are visible opaque lumps (due to partial undisintegration or insufficient water absorption and gelation). The water absorption rate is 20 times < 30 times.

[0087] 5: Forms a uniform, viscous gel mass with no visible opaque lumps and a water absorption rate >30 times.

[0088] The performance test results of the compositions provided in Examples 1-9 are shown in Table 3.

[0089] Table 3

[0090] Experiment Example 2

[0091] This experimental example further investigated the effects of the formulations and lubricants of Examples 1, 5, and 6 on tablet performance during scale-up production. It was found that the lubricant can be replaced with other conventional lubricants, such as talc, polyethylene glycol (PEG) 4000 or 6000. The choice of lubricant has little impact on tablet performance and can be adjusted according to the specific tableting equipment molds and tableting parameters in the scale-up process.

[0092] The tablets prepared using the formulation and process of the weight management composition of this invention exhibit the following final properties: hardness of 80-100 N, friability ≤0.5%, and complete disintegration (without residual tablet fragments) in a 100 ml solution (80 ml water + 20 ml simulated gastric juice) at 37°C. Furthermore, they form a viscous, viscous gel structure within 30-60 minutes. The preparation method is simple, making it suitable for large-scale development.

[0093] Experimental Example 3

[0094] This experimental example tests the physical volume-carrying and de-emptying effects of the composition for weight management provided in Example 1. The equipment used is a dynamic human gastrointestinal digestive system from Xiaodong Yijian (Suzhou) Instrument Equipment Co., Ltd. The simulated digestive fluid and high-fat meal formula used are as follows:

[0095] Digestive fluid simulation solution:

[0096] The digestive fluid simulation solution mainly consists of electrolyte reserves, enzymes, CaCl2(H2O)2, and water. Based on the literature [Minekus, M et al. "A standardized static in vitro digestion method suitable for food – an international consensus." Food & Function vol. 5, 6], the recommended electrolyte concentrations in saliva and gastric juice simulation solutions are shown in Table 4.

[0097] Table 4. Electrolyte concentrations in simulated saliva and gastric juice solutions.

[0098] The preparation of the digestive fluid simulation solution is as follows:

[0099] Saliva-simulated solution: Saliva-simulated electrolyte stock solution + CaCl2(H2O)2 + 6M HCl + deionized water + α-amylase (adjust pH to 7); (the final concentration of α-amylase in the saliva-simulated solution is 150 U / ml).

[0100] Gastric juice simulation solution: Gastric juice simulation solution electrolyte reserve + CaCl2(H2O)2 + 6M HCl + deionized water + pepsin (adjust pH to 1.6, then add pepsin. The final concentration of pepsin in the gastric juice simulation solution is 4000 U / mL. The enzyme concentration in the fasting state is adjusted to 20% of this concentration).

[0101] High-fat meals: Prepare FDA-approved high-fat diets [Food and Drug Administration. Guidance for industry: Assessing the effects of food on drugs in INDs and NDAs - Clinical Pharmacology considerations. US Department of Health and Human Services, Rockville, MD. 2019], with the following composition as shown in Table 5:

[0102] Table 5. Composition of high-fat meals

[0103] The dynamic in vitro gastric digestion experiment process is as follows:

[0104] 1. The experiment was divided into three groups: Composition Example 1, PL-1 (Plenity), and a control group. PL-1 (Plenity) hydrogel is a weight management product developed by a US company. Its main component is carboxymethyl cellulose cross-linked with citric acid to form a three-dimensional matrix. It absorbs water in the stomach, rapidly expands, and fills part of the stomach volume. After mixing with food, it forms a highly elastic, high-viscosity mixture, producing a feeling of fullness through neuroendocrine regulation. The gel particles are decomposed and inactivated in the large intestine and excreted with feces. This product has been certified by the US FDA and has obtained Class II medical device certification.

[0105] 2. Starting 1-2 minutes later, administer 200ml of 40℃ warm water (control group), 200ml of warm water + 5 tablets (0.6g / tablet) of the composition from Example 1 (Example 1 group), and 200ml of warm water + 3 tablets of Plenity product (PL-1 group).

[0106] 2. Start eating 10 minutes later (125g solid meal, 100ml milk). Mix with 55ml SSF for 1 minute before eating. Eat in 3 portions within 10 minutes, each portion consisting of 42g solid meal, 33ml milk, and 18.5ml SSF.

[0107] 3. From 0 to 10 minutes, the simulated gastric juice infusion rate is 1.0 ml / min; from 10 to 240 minutes, the simulated gastric juice infusion rate is 1.2-1.8 ml / min.

[0108] The results are shown in Figure 1 and Figure 2.

[0109] As can be seen from Figures 1 and 2, in the in vitro feeding simulation test, the gastric volume-filling performance and gastric emptying delay performance of the tablet of Example 1 were better than those of the control group, and were not inferior to the device PL-1 in some time periods.

[0110] Experiment Example 4

[0111] This experimental example references InQpharm's patent "Composition for Reducing Dietary Fat Absorption" and the in vitro experimental section on the inhibition of postprandial blood glucose by galactomannan, in order to preliminarily evaluate the ability of the hydrogel material composition of the present invention to reduce the absorption of oil (edible olive oil).

[0112] Emulsion preparation: 48ml of Sudan III-dyed olive oil was kept at 40℃; 0.58g of sodium deoxycholate was dissolved in 380ml of deionized water by ultrasonication and kept at 40℃; the oil and water phases were mixed and homogenized using an IKA T25 homogenizer at 9000 rpm for 5 minutes.

[0113] Oil adsorption / encapsulation experiment: Take 100 ml of the above homogenized emulsion in 4 groups. Groups 1 and 2 were added with the hydrogel material composition used in Example 1, namely konjac powder: resistant dextrin: galactomannan = 45:1:2, with added amounts of 1 g and 2 g, respectively, recorded as 1% and 2%; Group 3 was added with 2 g of galactomannan, recorded as 2%; Group 4 was not added with any substance as a blank control.

[0114] Results: A clear oil layer began to form in the control group after 40 seconds; while the water-oil interface of the emulsions of the 1% and 2% hydrogel material compositions was still relatively blurred at this time, and demulsification was slower than in the control group. Simultaneously, the emulsion of the 2% hydrogel component clearly solidified and encapsulated oil droplets. For the 2% galactomannan emulsion, obvious stratification occurred within 20 seconds, and its demulsification was faster than in the control group.

[0115] The results of this experiment show that galactomannan alone accelerates emulsion separation but does not encapsulate oils; while the hydrogel material composition of this invention has a significant ability to swell and encapsulate emulsions, possessing a novel function of adsorbing / encapsulating oils. Ingesting the hydrogel material composition of this invention in vivo is expected to exert its function of solidifying and encapsulating oils, reducing oil absorption in the small intestine while avoiding the side effects of oily stool leakage caused by unabsorbed oils in the small intestine, as seen with orlistat.

[0116] The embodiments described above are merely illustrative of several implementations of the present invention, designed to facilitate a detailed understanding of the technical solutions of the present invention, but should not be construed as limiting the scope of protection of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Industrial applicability

[0117] This invention provides a hydrogel material composition, a weight management composition, its preparation method, and its application. The hydrogel material composition comprises konjac flour, galactomannan, and resistant dextrin. The weight management composition comprises the following components in parts by weight: 40-60 parts of the hydrogel material composition, 10-40 parts of a disintegrant, 0-15 parts of an inorganic salt, and 10-35 parts of a filler. The composition prepared by this invention through specific component proportions possesses excellent formulation properties, disintegrant properties, and gelling properties simultaneously. The product exhibits high quality stability, making it suitable for large-scale application development. After consumption, it occupies space in the stomach, promoting satiety and reducing appetite, thereby achieving weight management and blood sugar control, demonstrating good economic value and application prospects.

Claims

1. A hydrogel material composition comprising konjac flour, galactomannan, and resistant dextrin.

2. The hydrogel material composition according to claim 1, characterized in that, The ratio of konjac powder, galactomannan, and resistant dextrin by weight is: 35-55 parts konjac powder, 1-10 parts galactomannan, and 0.5-10 parts resistant dextrin.

3. A weight management composition, characterized in that, The composition comprises the following components in parts by weight: 40-60 parts of the hydrogel material composition according to claim 1 or 2, 10-40 parts of disintegrant, 0-15 parts of inorganic salt, and 10-35 parts of filler.

4. The weight management composition according to claim 3, characterized in that, It also includes 0.2-2 parts of lubricant.

5. The weight management composition according to any one of claims 3-4, characterized in that, The filler is selected from at least one of fructooligosaccharides, sugar alcohols, starch, sucrose, lactose, and dextrin; Preferably, the filler comprises sugar alcohols and / or fructooligosaccharides.

6. The weight management composition according to any one of claims 3-5, characterized in that, The disintegrant is selected from at least one of microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, croscarmellose, and croscarmellose sodium; preferably microcrystalline cellulose.

7. The weight management composition according to any one of claims 3-6, characterized in that, The lubricant is selected from at least one of magnesium stearate, micronized silica gel, talc, magnesium lauryl sulfate, polyethylene glycol 4000, and polyethylene glycol 6000.

8. The weight management composition according to any one of claims 3-7, characterized in that, The weight management composition is in the form of a solid dosage form; Optionally, the solid dosage form is a tablet, capsule, powder, granule, or lozenge.

9. A method for preparing the weight management composition according to any one of claims 1-8, characterized in that, The process includes the following steps: mixing konjac powder, resistant dextrin, and galactomannan to obtain a premix; then mixing the premix with other components and compressing it into tablets.

10. Use of the hydrogel material composition of claim 1 or 2 or the weight management composition of any one of claims 3-8 in the preparation of a medicine or food related to human weight or health.

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