Sugar-controlling and fat-reducing composition for satiety as well as preparation method and application of sugar-controlling and fat-reducing composition

Abstract

The invention discloses a satiety sugar-controlling fat-reducing composition and a preparation method and application thereof, the satiety sugar-controlling fat-reducing composition comprises hydrogel particles, a white kidney bean extract, a mulberry leaf extract, alpha-lipoic acid, L-carnitine, a lotus leaf extract, medium chain triglyceride, polyethylene glycol and sorbitol, and the composition is a tablet. The components are matched with one another to effectively adjust the leptin level, improve appetite, increase energy consumption, adjust the fat metabolism process, reduce fat accumulation, improve fat consumption, inhibit the activity of alpha-amylase, reduce the conversion of carbohydrates into fat, block heat and fat intake, promote gastrointestinal motility and enhance the immunity of the human body. The effects of remarkably reducing the fat content and the body weight are achieved.

Description

Technical Field

[0001] The present invention belongs to the field of material mixing, and relates to mixing characterized by the properties or application fields of mixed materials, and specifically relates to a satiety, sugar-controlling, and fat-reducing composition, and a preparation method and application thereof. Background Art

[0002] With the development of industrialization, urbanization, population aging, and changes in ecological environment, lifestyle, and dietary structure, obesity has become one of the main causes of harm to human health worldwide. Obesity can cause many chronic diseases, such as diabetes, hypertension, hyperlipidemia, coronary heart disease, fatty liver, and endocrine disorders. Health problems caused by obesity must be given sufficient attention, and weight loss is the main means to deal with obesity-related problems. Chinese patent 202311296739.7 provides a food composition with the effect of controlling blood sugar rise, a preparation method, and an application thereof. The composition is composed of white kidney bean extract, seaweed powder, L-arabinose, mulberry leaf extract, golden top pleurotus concentrated powder, black wolfberry, and bitter melon peptide as main ingredients, and the composition is prepared by granulation and tableting. Chinese patent CN202411008548.0 discloses a fat-reducing nutritional composition and preparation method based on slowing down the formation of carbohydrates and fat. The composition includes isomalt, oligofructose, collagen peptide, mulberry leaf, white kidney bean and auxiliary materials. The above patent can only inhibit the absorption of blood sugar and the synthesis of fat at the digestion end, and cannot reduce the intake of carbohydrates from the source. It is only suitable for non-obese people to maintain normal weight. Chinese patent CN202210614793.0 provides a long-acting satiety composition, preparation method and use. The composition is compressed into tablets with hydroxypropyl methylcellulose and carboxymethyl cellulose as the main skeleton materials. After taking it, it can increase satiety, reduce appetite, reduce the user's energy intake, control the user's weight, and achieve weight loss. However, the long-acting satiety composition has a water absorption and expansion rate of only 4-8 times, a low expansion coefficient, and a weak effect on increasing the user's satiety. Moreover, the long-acting satiety composition does not have ingredients that regulate blood sugar and inhibit fat synthesis. Users need to persist in using it for a long time and cooperate with diet control to achieve weight loss, and the effect is slow. Therefore, it is necessary to develop a satiety, sugar control and fat reduction product suitable for obese people. Summary of the invention

[0003] In order to overcome the above-mentioned deficiencies in the prior art, the purpose of the present invention is to provide a satiety, sugar-control and fat-reducing composition, and a preparation method and application thereof. Through the synergistic combination of hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, medium-chain triglycerides and lotus leaf extract, the prepared composition has the three functions of providing satiety and reducing food intake, controlling blood sugar rise and burning fat, and can effectively reduce the weight of the user; through the preparation of hot-melt hydrogel particles, the problems of poor plasticity of hydrogel particles, difficulty in tableting and easy breakage, and poor mixing uniformity with other materials are overcome.

[0004] The purpose of the present invention is achieved by at least one of the following technical solutions: The present invention provides a satiety control sugar and fat reduction composition, comprising hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, medium-chain triglycerides and lotus leaf extract; the composition is a tablet; The mass of the hot-melt hydrogel particles accounts for 30-80% of the total mass of the composition; the mass of the white kidney bean extract accounts for 5-30% of the total mass of the tablet composition; the mass of the mulberry leaf extract accounts for 2.5-5% of the total mass of the composition; the mass of the α-lipoic acid accounts for 2.5-5% of the total mass of the composition; the mass of the L-carnitine accounts for 5-20% of the total mass of the composition; the mass of the medium-chain triglyceride accounts for 3-7% of the total mass of the composition; the mass of the lotus leaf extract accounts for 2-3% of the total mass of the composition; The preparation process of the hot melt hydrogel particles comprises the following steps: (1) Preparation of hydrogel particles: crushing the hydrogel into 40-80 meshes to obtain hydrogel particles; (2) Hot melt granulation: Place the hydrogel particles, polyethylene glycol and sorbitol into a fluidized bed, heat at 80-110°C, and then cool to 15-30°C to obtain hot melt hydrogel particles.

[0005] Furthermore, in step (1), the preparation method of the hydrogel is: dissolving sodium carboxymethyl cellulose and pectin in water, drying at 100-120° C. for 1-12 h for physical cross-linking to obtain the hydrogel.

[0006] Furthermore, in step (2), the polyethylene glycol is polyethylene glycol 4000 or polyethylene glycol 6000.

[0007] Furthermore, in step (2), the mass ratio of the hydrogel, polyethylene glycol and sorbitol is 10-50:5-10:10-20.

[0008] Furthermore, in step (2), the mass ratio of hydrogel, polyethylene glycol and sorbitol is 30:10:20, 10:5:15 or 50:10:20.

[0009] Furthermore, in step (2), the heating time is 20-60 minutes.

[0010] Furthermore, in step (2), during the heating process and the cooling process, the frequency of the fluidized bed fan is independently set to 20-50 Hz.

[0011] Furthermore, the raw materials of the satiety, sugar-control and fat-reducing composition include the following components by weight: 10-50 parts of hydrogel, 10-20 parts of sorbitol, 5-10 parts of polyethylene glycol, 5-30 parts of white kidney bean extract, 2.5-5 parts of mulberry leaf extract, 2.5-5 parts of alpha-lipoic acid, 5-20 parts of L-carnitine, 3-7 parts of medium chain triglycerides and 2-3 parts of lotus leaf extract.

[0012] Furthermore, the raw materials of the satiety, sugar-control and fat-reducing composition include the following components by weight: 10-50 parts of hydrogel, 15-20 parts of sorbitol, 5-10 parts of polyethylene glycol, 5-30 parts of white kidney bean extract, 2.5-5 parts of mulberry leaf extract, 2.5-5 parts of alpha-lipoic acid, 5-20 parts of L-carnitine, 3-7 parts of medium chain triglycerides and 2-3 parts of lotus leaf extract.

[0013] The present invention also provides a method for preparing a satiety sugar-controlling and fat-reducing composition as described in any one of the above items, comprising the following steps: (1) Preparation of hydrogel particles: crushing the hydrogel into 40-80 meshes to obtain hydrogel particles; (2) Hot melt granulation: hydrogel particles, polyethylene glycol and sorbitol are placed in a fluidized bed, heated at 80-110°C, and then cooled to 15-30°C to obtain hot melt hydrogel particles; (3) Mixing and tableting: The hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, lotus leaf extract and medium-chain triglycerides are homogeneously mixed and tableted to obtain a satiety, sugar-control and fat-reducing composition.

[0014] Furthermore, the raw materials of the satiety, sugar-control and fat-reducing composition include the following components by weight: 10-50 parts of hydrogel, 10-20 parts of sorbitol, 5-10 parts of polyethylene glycol, 5-30 parts of white kidney bean extract, 2.5-5 parts of mulberry leaf extract, 2.5-5 parts of alpha-lipoic acid, 5-20 parts of L-carnitine, 3-7 parts of medium chain triglycerides and 2-3 parts of lotus leaf extract.

[0015] Furthermore, in step (2), the heating time is 20-60 minutes.

[0016] Furthermore, in step (2), during the heating process and the cooling process, the frequency of the fluidized bed fan is independently set to 20-50 Hz.

[0017] Furthermore, in step (3), the homogenous mixing is carried out in a mixer.

[0018] The present invention also provides the use of the satiety, sugar-control and fat-reducing composition described in the aforementioned technical scheme or the satiety, sugar-control and fat-reducing composition prepared by the preparation method described in the aforementioned technical scheme in the preparation of foods, medicines or health products with stomach filling, weight control and blood sugar control effects.

[0019] Compared with the prior art, the present invention has the following advantages and beneficial effects: (1) The satiety, sugar control and fat reduction composition of the present invention includes hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, medium-chain triglycerides and lotus leaf extract. The components cooperate with each other and complement each other. The composition has the effects of satiety, sugar control and fat reduction, and can effectively adjust leptin levels, improve appetite, increase energy consumption, adjust fat metabolism, reduce fat accumulation, and increase fat consumption. At the same time, it can also inhibit α-amylase activity, reduce the conversion of carbohydrates into fat, block the intake of calories and fat, and promote gastrointestinal peristalsis, so as to achieve the effect of significantly reducing fat content and body fat rate. Compared with weight loss products that only have the single functions of satiety, sugar control or fat reduction, the satiety, sugar control and fat reduction composition of the present invention can more effectively reduce the weight of the user.

[0020] (2) In the preparation method of a satiety control sugar and fat reduction composition provided by the present invention, a polymer polyethylene glycol with a relatively low viscosity flow temperature (Tf) and an adhesive sorbitol are selected. After heating, the two can be used as a liquid adhesive, and no water or organic solvent or other adhesives need to be added. The hydrogel particles do not need to be dried after granulation, which effectively overcomes the problem that the hydrogel particles have high hardness, poor plasticity, and easy water absorption and swelling, and cannot be wet granulated. The method can only be used to reduce the content of hydrogel particles in the product or sacrifice hardness for direct mixing and tableting. Compared with other granulation methods, the mixing of the components is more uniform, simpler and more convenient, and the power consumption is low, which saves production costs. The final product has no solvent residue, and at the same time improves the sensory experience of the user of the composition. DETAILED DESCRIPTION

[0021] The present invention provides a satiety control sugar and fat reduction composition, comprising hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, medium-chain triglycerides and lotus leaf extract; the composition is a tablet; The mass of the hot-melt hydrogel particles accounts for 30-80% of the total mass of the composition; the mass of the white kidney bean extract accounts for 5-30% of the total mass of the tablet composition; the mass of the mulberry leaf extract accounts for 2.5-5% of the total mass of the composition; the mass of the α-lipoic acid accounts for 2.5-5% of the total mass of the composition; the mass of the L-carnitine accounts for 5-20% of the total mass of the composition; the mass of the medium-chain triglyceride accounts for 3-7% of the total mass of the composition; the mass of the lotus leaf extract accounts for 2-3% of the total mass of the composition; The preparation process of the hot melt hydrogel particles comprises the following steps: (1) Preparation of hydrogel particles: crushing the hydrogel into 40-80 meshes to obtain hydrogel particles; (2) Hot melt granulation: Place the hydrogel particles, polyethylene glycol and sorbitol into a fluidized bed, heat at 80-110°C, and then cool to 15-30°C to obtain hot melt hydrogel particles.

[0022] The hot-melt hydrogel particles in the composition can absorb water and swell, and can provide a sense of fullness after taking 4g, reducing the human body's food intake by about 25-62.5%; the white kidney bean extract can prevent the hydrolysis and digestion of the remaining ingested carbohydrates, and at the same time, it is directly discharged from the body through the tail end of the digestive tract without affecting the absorption and metabolism of other nutrients such as proteins and vitamins; the mulberry leaf extract inhibits the activity of disaccharide decomposition enzymes through the alkaloid DNJ (1-deoxynojirimycin), thereby inhibiting the absorption of disaccharides by the small intestine; α-lipoic acid increases the expression and activity of glucose transporters (GLUT4) in pancreatic islet cells, thereby enhancing the ability of glucose to enter cells, thereby lowering blood sugar levels; L-carnitine can increase the β-oxidation metabolic rate of fat and accelerate the consumption of fat by mitochondria in cells; nuciferine in lotus leaf extract can increase the activity of lipid metabolism enzymes; the decomposition of medium-chain triglycerides can generate ketone bodies, increase the production of body heat, promote the oxidation and decomposition of fat, and reduce fat accumulation. Multiple substances work synergistically to achieve a weight loss effect.

[0023] The hydrogel particles are crystals formed after high-temperature cross-linking and crushing. They are not sticky in a dry state. After being mixed with the hot-melt materials polyethylene glycol and sorbitol and heated to a certain temperature, the hot-melt materials are in a liquid state and coated on the surface of the hydrogel particles. As the hot-melt material cools, it returns to a solid state and is wrapped on the surface of the hydrogel particles, which enhances the adhesion between the particles, thereby increasing the compressibility of the hydrogel particles and making the components mix more evenly.

[0024] In some embodiments of the present invention, the hydrogel is formed by physical crosslinking of sodium carboxymethyl cellulose and pectin. The hydrogel can be a commercially available product or can be prepared by itself. The preparation method refers to Chinese patent CN115918889A. The entire text of CN115918889A is introduced into the present invention and will not be repeated here.

[0025] In some embodiments of the present invention, in step (2), the polyethylene glycol is polyethylene glycol 4000 or polyethylene glycol 6000.

[0026] In some embodiments of the present invention, in step (2), the mass ratio of hydrogel, polyethylene glycol and sorbitol is 10-50:5-10:10-20. Preferably, in step (2), the mass ratio of hydrogel, polyethylene glycol and sorbitol is 30:10:20, 10:5:15 or 50:10:20.

[0027] In some embodiments of the present invention, in step (2), the heating time is 20-60 minutes.

[0028] In some embodiments of the present invention, in step (2), during the heating process and during the cooling process, the frequency of the fluidized bed fan is independently set to 20-50 Hz.

[0029] In some embodiments of the present invention, the raw materials of the satiety control sugar and fat reduction composition include the following components by weight: 10-50 parts of hydrogel, 10-20 parts of sorbitol, 5-10 parts of polyethylene glycol, 5-30 parts of white kidney bean extract, 2.5-5 parts of mulberry leaf extract, 2.5-5 parts of α-lipoic acid, 5-20 parts of L-carnitine, 3-7 parts of medium-chain triglycerides, and 2-3 parts of lotus leaf extract. Preferably, the raw materials of the satiety control sugar and fat reduction composition include the following components by weight: 10-50 parts of hydrogel, 15-20 parts of sorbitol, 5-10 parts of polyethylene glycol, 5-30 parts of white kidney bean extract, 2.5-5 parts of mulberry leaf extract, 2.5-5 parts of α-lipoic acid, 5-20 parts of L-carnitine, 3-7 parts of medium-chain triglycerides, and 2-3 parts of lotus leaf extract.

[0030] The present invention also provides a method for preparing a satiety sugar-controlling and fat-reducing composition as described in any one of the above items, comprising the following steps: (1) Preparation of hydrogel particles: crushing the hydrogel into 40-80 meshes to obtain hydrogel particles; (2) Hot melt granulation: hydrogel particles, polyethylene glycol and sorbitol are placed in a fluidized bed, heated at 80-110°C, and then cooled to 15-30°C to obtain hot melt hydrogel particles; (3) Mixing and tableting: The hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, lotus leaf extract and medium-chain triglycerides are homogeneously mixed and tableted to obtain a satiety, sugar-control and fat-reducing composition.

[0031] In some embodiments of the present invention, the raw materials of the satiety control sugar and fat reduction composition include the following components by weight: 10-50 parts of hydrogel, 10-20 parts of sorbitol, 5-10 parts of polyethylene glycol, 5-30 parts of white kidney bean extract, 2.5-5 parts of mulberry leaf extract, 2.5-5 parts of α-lipoic acid, 5-20 parts of L-carnitine, 3-7 parts of medium-chain triglycerides, and 2-3 parts of lotus leaf extract. Preferably, the raw materials of the satiety control sugar and fat reduction composition include the following components by weight: 10-50 parts of hydrogel, 15-20 parts of sorbitol, 5-10 parts of polyethylene glycol, 5-30 parts of white kidney bean extract, 2.5-5 parts of mulberry leaf extract, 2.5-5 parts of α-lipoic acid, 5-20 parts of L-carnitine, 3-7 parts of medium-chain triglycerides, and 2-3 parts of lotus leaf extract.

[0032] In some embodiments of the present invention, in step (2), the heating time is 20-60 minutes.

[0033] In some embodiments of the present invention, in step (2), during the heating process and during the cooling process, the frequency of the fluidized bed fan is independently set to 20-50 Hz.

[0034] In some embodiments of the present invention, step (3) specifically comprises: adding hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, lotus leaf extract and medium-chain triglycerides in sequence, and homogenously mixing to obtain a satiety, sugar-control and fat-reducing composition.

[0035] In some embodiments of the present invention, in step (3), the homogenous mixing is performed in a mixer.

[0036] The present invention also provides the use of the satiety, sugar-control and fat-reducing composition described in the aforementioned technical scheme or the satiety, sugar-control and fat-reducing composition prepared by the preparation method described in the aforementioned technical scheme in the preparation of foods, medicines or health products with stomach filling, weight control and blood sugar control effects.

[0037] The specific implementation of the present invention is further described below in conjunction with examples, but the implementation and protection of the present invention are not limited thereto. It should be noted that if there are processes that are not particularly described in detail below, they can be implemented or understood by those skilled in the art with reference to the prior art. If the manufacturer of the reagents or instruments used is not indicated, they are deemed to be conventional products that can be purchased commercially.

[0038] In the embodiments and comparative examples of the present invention, the white kidney bean extract was purchased from Yunnan Tianbaohua Biological Resources Development Co., Ltd., model number P40; Mulberry leaf extract was purchased from Huangshan Hualuyuan Biotechnology Co., Ltd., with a DNJ content of 1%-2%; α-Lipoic acid was purchased from: Hunan Yunbang Biotechnology Co., Ltd., specification: active ingredient 99%; L-carnitine was purchased from Chengdu Wanxiang Hongrun Biotechnology Co., Ltd., specification: active ingredient 99%; Medium chain triglycerides were purchased from Xi'an Tianguangyuan Biotechnology Co., Ltd. Specification: active ingredient 70%; Lotus leaf extract was purchased from Shaanxi Xintianyu Biotechnology Co., Ltd., model 10:1, nuciferine content 2%-10%; Polyethylene glycol 6000 was purchased from Shandong Ruisheng Pharmaceutical Excipients Co., Ltd., models PEG-4000 and PEG-6000; Sorbitol was purchased from Zhejiang Huakang Pharmaceutical Co., Ltd., model number HKSD40.

[0039] Example 1

[0040] A satiety-controlling sugar-fat-reducing composition comprises the following components in parts by weight: 60 parts of hot-melt hydrogel particles, 10 parts of white kidney bean extract, 5 parts of mulberry leaf extract, 5 parts of alpha-lipoic acid, 10 parts of L-carnitine, 7 parts of medium-chain triglycerides and 3 parts of lotus leaf extract.

[0041] The preparation method of the satiety sugar-controlling and fat-reducing composition is as follows: (1) Preparation of hydrogel particles: as described in Example 2 of patent CN115918889A, 67 parts of sodium carboxymethyl cellulose and 1 part of pectin were dissolved in 1111 parts of water and stirred for 2 hours, dried at a drying temperature of 110°C for 8 hours, crushed and sieved, and 40-80 mesh hydrogel particles were taken for use; (2) Hot melt granulation: 30 parts of 40-80 mesh hydrogel particles, 20 parts of sorbitol and 10 parts of polyethylene glycol 4000 were placed in a fluidized bed, and the heating temperature was set to 80°C, the fan frequency was set to 35 Hz, and the time was set to 60 min; then the heating was stopped, the fan frequency was set to 35 Hz, and the temperature was reduced to 15-30°C to obtain hot melt hydrogel particles; (3) Mixing and tableting: put the hot-melt hydrogel particles, 10 parts of white kidney bean extract, 5 parts of mulberry leaf extract, 5 parts of α-lipoic acid, 10 parts of L-carnitine, 7 parts of medium-chain triglycerides and 3 parts of lotus leaf extract into a mixer in sequence, mix them, and press them into tablets.

[0042] Example 2

[0043] A satiety-controlling sugar-fat-reducing composition comprises the following components in parts by weight: 30 parts of hot-melt hydrogel particles, 30 parts of white kidney bean extract, 5 parts of mulberry leaf extract, 5 parts of alpha-lipoic acid, 20 parts of L-carnitine, 7 parts of medium-chain triglycerides and 3 parts of lotus leaf extract.

[0044] The preparation method of the satiety sugar-controlling and fat-reducing composition is as follows: (1) Preparation of hydrogel particles: as described in Example 2 of patent CN115918889A, 67 parts of sodium carboxymethyl cellulose and 1 part of pectin were dissolved in 1111 parts of water and stirred for 2 hours, dried at a drying temperature of 110°C for 8 hours, crushed and sieved, and 40-80 mesh hydrogel particles were taken for use; (2) Hot melt granulation: 10 parts of 40-80 mesh hydrogel particles, 15 parts of sorbitol and 5 parts of polyethylene glycol 6000 were placed in a fluidized bed, and the heating temperature was set to 110°C and the fan frequency was set to 20 Hz for 20 min. Then the heating was stopped and the fan frequency was set to 35 Hz. The temperature was allowed to drop to 15-30°C to obtain hot melt hydrogel particles. (3) Mixing and tableting: put the hot-melt hydrogel particles, 30 parts of white kidney bean extract, 5 parts of mulberry leaf extract, 5 parts of α-lipoic acid, 20 parts of L-carnitine, 7 parts of medium-chain triglycerides and 3 parts of lotus leaf extract into a mixer in sequence, mix them, and press them into tablets.

[0045] Example 3

[0046] A satiety-controlling sugar-fat-reducing composition comprises the following components in parts by weight: 80 parts of hot-melt hydrogel particles, 5 parts of white kidney bean extract, 2.5 parts of mulberry leaf extract, 2.5 parts of alpha-lipoic acid, 5 parts of L-carnitine, 3 parts of medium-chain triglycerides and 2 parts of lotus leaf extract.

[0047] The preparation method of the satiety sugar-controlling and fat-reducing composition is as follows: (1) Preparation of hydrogel particles: as described in Example 2 of patent CN115918889A, 67 parts of sodium carboxymethyl cellulose and 1 part of pectin were dissolved in 1111 parts of water and stirred for 2 hours, dried at a drying temperature of 110°C for 8 hours, crushed and sieved, and 40-80 mesh hydrogel particles were taken for use; (2) Hot melt granulation: 50 parts of 40-80 mesh hydrogel particles, 20 parts of sorbitol and 10 parts of polyethylene glycol 6000 were placed in a fluidized bed, and the heating temperature was set to 95°C and the fan frequency was set to 50 Hz for 30 min; then the heating was stopped and the fan frequency was set to 35 Hz, and the temperature was allowed to drop to 15-30°C to obtain hot melt hydrogel particles; (3) Mixing and tableting: put the hot-melt hydrogel particles, 5 parts of white kidney bean extract, 2.5 parts of mulberry leaf extract, 2.5 parts of α-lipoic acid, 5 parts of L-carnitine, 3 parts of medium-chain triglycerides and 2 parts of lotus leaf extract into a mixer in sequence, mix them, and press them into tablets.

[0048] Comparative Example 1 Comparative Example 1 comprises the following components in parts by weight: 70 parts of sorbitol, 10 parts of polyethylene glycol 6000, 5 parts of white kidney bean extract, 2.5 parts of mulberry leaf extract, 2.5 parts of α-lipoic acid, 5 parts of L-carnitine, 3 parts of medium chain triglycerides and 2 parts of lotus leaf extract.

[0049] The preparation method is as follows: Mixing and tableting: 70 parts of sorbitol, 10 parts of polyethylene glycol 6000, 5 parts of white kidney bean extract, 2.5 parts of mulberry leaf extract, 2.5 parts of α-lipoic acid, 5 parts of L-carnitine, 3 parts of medium-chain triglycerides and 2 parts of lotus leaf extract were put into a mixer in sequence, mixed, and tableted to prepare Comparative Example 1.

[0050] Comparative Example 1 lacks hydrogel particles relative to Example 3 and has no hot melt granulation process.

[0051] Comparative Example 2 Comparative Example 2 includes the following components in parts by weight: 90 parts of hot-melt hydrogel particles, 5 parts of L-carnitine, 3 parts of medium-chain triglycerides and 2 parts of lotus leaf extract.

[0052] The preparation method is as follows: (1) Preparation of hydrogel particles: as described in Example 2 of patent CN115918889A, 67 parts of sodium carboxymethyl cellulose and 1 part of pectin were dissolved in 1111 parts of water and stirred for 2 hours, dried at a drying temperature of 110°C for 8 hours, crushed and sieved, and 40-80 mesh hydrogel particles were taken for use; (2) Hot melt granulation: 50 parts of 40-80 mesh hydrogel particles, 30 parts of sorbitol, and 10 parts of polyethylene glycol 6000 were placed in a fluidized bed, and the heating temperature was set to 95°C and the fan frequency was set to 50 Hz for 30 min; then the heating was stopped and the fan frequency was set to 35 Hz. When the temperature dropped to 15-30°C, hot melt hydrogel particles were obtained; (3) Mixing and tableting: hot-melt hydrogel particles, 5 parts of L-carnitine, 3 parts of medium-chain triglycerides and 2 parts of lotus leaf extract were sequentially put into a mixer, mixed, and tableted to prepare Comparative Example 2.

[0053] Comparative Example 2 lacks white kidney bean extract, mulberry leaf extract and α-lipoic acid relative to Example 3.

[0054] Comparative Example 3 Comparative Example 3 includes components in parts by weight: 90 parts of hot-melt hydrogel particles, 5 parts of white kidney bean extract, 2.5 parts of mulberry leaf extract and 2.5 parts of α-lipoic acid.

[0055] The preparation method is as follows: (1) Preparation of hydrogel particles: as described in Example 2 of patent CN115918889A, 67 parts of sodium carboxymethyl cellulose and 1 part of pectin were dissolved in 1111 parts of water and stirred for 2 hours, dried at a drying temperature of 110°C for 8 hours, crushed and sieved, and 40-80 mesh hydrogel particles were taken for use; (2) Hot melt granulation: 50 parts of 40-80 mesh hydrogel particles, 30 parts of sorbitol, and 10 parts of polyethylene glycol 6000 were placed in a fluidized bed, and the heating temperature was set to 95°C and the fan frequency was set to 50 Hz for 30 min; then the heating was stopped and the fan frequency was set to 35 Hz. When the temperature dropped to 15-30°C, hot melt hydrogel particles were obtained; (3) Mixing and tableting: hot-melt hydrogel particles, 5 parts of white kidney bean extract, 2.5 parts of mulberry leaf extract and 2.5 parts of α-lipoic acid were sequentially put into a mixer, mixed, and tableted to prepare Comparative Example 3.

[0056] Comparative Example 3 lacks L-carnitine, medium chain triglycerides and lotus leaf extract relative to Example 3.

[0057] Comparative Example 4 Comparative Example 4 includes the following components in parts by weight: 30 parts of hydrogel particles, 20 parts of sorbitol, 10 parts of polyethylene glycol 4000, 10 parts of white kidney bean extract, 5 parts of mulberry leaf extract, 5 parts of α-lipoic acid, 10 parts of L-carnitine, 7 parts of medium chain triglycerides and 3 parts of lotus leaf extract.

[0058] The preparation method is as follows: (1) Preparation of hydrogel particles: as described in Example 2 of patent CN115918889A, 67 parts of sodium carboxymethyl cellulose and 1 part of pectin were dissolved in 1111 parts of water and stirred for 2 hours, dried at a drying temperature of 110°C for 8 hours, crushed and sieved, and 40-80 mesh hydrogel particles were taken for use; (2) Mixing and tableting: 30 parts of 40-80 mesh hydrogel particles, 20 parts of sorbitol, 10 parts of polyethylene glycol 4000, 10 parts of white kidney bean extract, 5 parts of mulberry leaf extract, 5 parts of α-lipoic acid, 10 parts of L-carnitine, 7 parts of medium-chain triglycerides and 3 parts of lotus leaf extract were sequentially put into a mixer for mixing, and tableting was performed to prepare Comparative Example 4.

[0059] Comparative Example 4 lacks the hot melt granulation process relative to Example 1.

[0060] Comparative Example 5 Comparative Example 5 includes the following components in parts by weight: 10 parts of hydrogel particles, 15 parts of sorbitol, 5 parts of polyethylene glycol 6000, 30 parts of white kidney bean extract, 5 parts of mulberry leaf extract, 5 parts of α-lipoic acid, 20 parts of L-carnitine, 7 parts of medium chain triglycerides and 3 parts of lotus leaf extract.

[0061] The preparation method is as follows: (1) Preparation of hydrogel particles: as described in Example 2 of patent CN115918889A, 67 parts of sodium carboxymethyl cellulose and 1 part of pectin were dissolved in 1111 parts of water and stirred for 2 hours, dried at a drying temperature of 110°C for 8 hours, crushed and sieved, and 40-80 mesh hydrogel particles were taken for use; (2) Mixing and tableting: 10 parts of 40-80 mesh hydrogel particles, 15 parts of sorbitol, 5 parts of polyethylene glycol 6000, 30 parts of white kidney bean extract, 5 parts of mulberry leaf extract, 5 parts of α-lipoic acid, 20 parts of L-carnitine, 7 parts of medium-chain triglycerides and 3 parts of lotus leaf extract were sequentially put into a mixer for mixing, and tableting was performed to prepare Comparative Example 5.

[0062] Comparative Example 5 lacks the hot melt granulation process relative to Example 2.

[0063] Comparative Example 6 Comparative Example 6 includes the following components in parts by weight: 50 parts of hydrogel particles, 20 parts of sorbitol, 10 parts of polyethylene glycol 6000, 5 parts of white kidney bean extract, 2.5 parts of mulberry leaf extract, 2.5 parts of α-lipoic acid, 5 parts of L-carnitine, 3 parts of medium chain triglycerides and 2 parts of lotus leaf extract.

[0064] The preparation method is as follows: (1) Preparation of hydrogel particles: as described in Example 2 of patent CN115918889A, 67 parts of sodium carboxymethyl cellulose and 1 part of pectin were dissolved in 1111 parts of water and stirred for 2 hours, dried at a drying temperature of 110°C for 8 hours, crushed and sieved, and 40-80 mesh hydrogel particles were taken for use; (2) Mixing and tableting: 50 parts of 40-80 mesh hydrogel particles, 20 parts of sorbitol, 10 parts of polyethylene glycol 6000, 5 parts of white kidney bean extract, 2.5 parts of mulberry leaf extract, 2.5 parts of α-lipoic acid, 5 parts of L-carnitine, 3 parts of medium-chain triglycerides and 2 parts of lotus leaf extract were sequentially put into a mixer for mixing, and tableting was performed to prepare Comparative Example 6.

[0065] Comparative Example 6 lacks the hot melt granulation process relative to Example 3.

[0066] Analysis and Conclusion 1. Sample evaluation: A. Uniformity test: Conduct content uniformity test before tableting to ensure that the material content is uniform and stable during tableting. Perform uniformity test on Examples 1-3 respectively, and take samples from the upper, middle and lower parts of each sample to test the content of L-carnitine and lotus leaf extract. The amount of L-carnitine added is 5-20%, and the amount of lotus leaf extract added is 2-3%. Whether the L-carnitine and lotus leaf extract are homogeneously mixed is representative of the overall uniformity of the sample.

[0067] The sampling method is: according to the sampling plan for the mixing stage in the "Technical Guiding Principles for Research on Mixing Uniformity and Unit Uniformity of Central Control Dosage of Chemical Oral Solid Preparations (Trial)": select at least 10 sampling points in the upper, middle and lower parts of the double-cone mixer (3 sampling points in the upper part, 4 sampling points in the middle part, and 3 sampling points in the lower part), take at least 3 samples from each sampling point, and the sampling size of a single sample is 10g. If the relative standard deviation (RSD) is ≤5.0%, the mixing uniformity of this embodiment is acceptable.

[0068] The testing standards for active ingredients are as follows: 《SN / T 4052-2014 Determination of Nuciferine in Exported Health Foods》 GB 1903.13-2016 National Food Safety Standard Food Nutrition Fortifier L-Carnitine (L-Carnitine) Tableting test: Tablet hardness and friability tests were performed on the tablet samples of the compositions prepared in Examples 1-3 and the tablet samples prepared in Comparative Examples 4-6. The test method is as follows: Hardness measurement: Take 10 samples to be tested and put them into the test chamber of YD-20KZ intelligent tablet hardness tester in turn, then add dynamic force to measure and record the data; Friability determination: According to the "Tablet Friability Test Method" in the "Chinese Pharmacopoeia", 10 tablets were sampled and the test parameters were set at 21°C, 25 r / min, and 4 min. The tablet was tested using a four-purpose tablet tester. The tablet friability was calculated according to formula (1). Tablets with brittle fractures were judged as unqualified.

[0069] Friability / %=[(m1-m2) / m1]×100%, Wherein, m1 is the total weight of the compressed candy before the test, and the unit of m1 is g; m2 is the total weight of the tablet candy after the test, and the unit of m2 is g. The tablet test results are shown in Table 1.

[0070] C. Composition expansion multiple test: Take 1 g of the tablet samples of the compositions prepared in Examples 1-3, Comparative Example 1 and Comparative Example 6 respectively, put them into a clean beaker filled with 200 ml of simulated gastric juice (artificial gastric juice: water = 1:8), put them in a constant temperature water bath at 37°C for 60 min and 240 min, then pour them into an 80-mesh stainless steel sieve (weight M1) and let them stand for 10 minutes, weigh M2, and calculate the water absorption multiple according to the following formula: The test results of the composition expansion multiple are shown in Table 2.

[0071] Expansion multiple = (M2-M1-1) / 1.

[0072] The units of M1 and M2 are both g.

[0073] Prepare artificial gastric juice according to the Chinese Pharmacopoeia 2010 edition as follows: Take 16.4 ml of dilute hydrochloric acid, add about 800 ml of water and 10 g of pepsin, shake well, and dilute with water to 1000 ml.

[0074] D. Postprandial blood glucose level test: 20 healthy adults were selected for each group, including 10 men and 10 women, aged 25-40 years old, with a BMI of 18.8-23.9 kg / m 2 , no history of diabetes (or impaired glucose tolerance), no other metabolic diseases, digestive system diseases, endocrine system diseases and mental illnesses, etc.; no history of allergy and intolerance to the tested food, normal oral glucose tolerance test, regular diet, no recent gastrointestinal diseases and taking any medications, and qualified physical examination. Before the experiment, the subjects were trained and signed informed consent. Stop eating and drinking after 22:00 the night before the experiment, and test the blood sugar fluctuation after breakfast.

[0075] Control group: normal consumption of reference food white bread for breakfast; Experimental group: 4 g of each embodiment or comparative example sample was consumed within 30 minutes before breakfast, and white bread, the reference food, was consumed normally for breakfast; With time as the horizontal axis and blood glucose value at each time point - fasting blood glucose value as the vertical axis, a blood glucose response curve was prepared, and the area under the curve (IAUC) above the fasting blood glucose level was calculated. The inhibition rate = (reference food IAUC - example IAUC) / reference food IAUC * 100%. The postprandial blood glucose level test results are shown in Table 3.

[0076] The blood sugar test uses a Roche blood sugar meter. The specific steps for measuring fingertip blood sugar are as follows: (1) Collect blood from the fingertip, discard the first drop, and measure fasting blood sugar twice at 5-min intervals and record the results; (2) Drink 50 mL of water; (3) After 5 minutes, eat white bread (50 g carbohydrate intake) and 200 mL water (completed within 5 minutes) eating); (4) Collect blood from fingertips to test blood sugar and record it (15 min, 30 min, 45 min, 60 min, 90 min, 120 min). D. Population weight test: 20 healthy adults were selected for each group, including 10 men and 10 women, aged 23-50 years old, with a BMI of 24-30 kg / m 2 , no other metabolic diseases, digestive system diseases, endocrine system diseases and mental diseases, etc.; no history of allergy and intolerance to the tested food, no recent gastrointestinal diseases and no medication. The subjects were trained before the trial and signed the informed consent.

[0077] Control group 1: Eat normally according to the daily nutritional intake recommended by the Chinese Nutrition Society; Control group 2: Eat normally according to the daily nutritional intake recommended by the Chinese Nutrition Society, and consume the composition provided by Example 2 of Chinese patent CN202311296739.7 twice a day within 30 minutes before meals, 4g each time; Experimental group: Eat normally according to the daily nutrient intake recommended by the Chinese Nutrition Association, consume the composition provided by each embodiment or comparative example twice a day within 30 minutes before meals, 4 g each time, for 2 consecutive months, and check and record the weight and eating conditions of the subjects in each group, statistically analyze the results, calculate the average value, and the weight test results of the population are shown in Table 4.

[0078] 2. Results and analysis: Table 1 Mixing uniformity test results

[0079] Table 2 Tableting test results

[0080] Table 3 Long-term expansion multiple test results

[0081] Table 4 Average inhibition rate of each group

[0082] Table 5 Body weight changes in each group

[0083] According to the results in Table 1, the relative standard deviations (RSDs) of the L-carnitine and nuciferine content values ​​in Example 1 are 0.77% and 2.20%; the relative standard deviations (RSDs) of the L-carnitine and nuciferine content values ​​in Example 2 are 0.40% and 2.33%; the relative standard deviations (RSDs) of the L-carnitine and nuciferine content values ​​in Example 3 are 1.17% and 2.75%, and the relative standard deviation (RSD) is <5%, indicating that the material mixing uniformity is good.

[0084] Table 2 The results show that the hydrogel particles in Comparative Examples 4-6 were not subjected to hot melt granulation and were directly compressed. The hardness was low, some of them could not be formed, and they broke in the friability test, which did not meet the qualified standards of the tablets in the "Chinese Pharmacopoeia". Among them, 10% hydrogel particles were added to Comparative Example 5, which was not subjected to hot melt granulation, and the tablet hardness was low. 50% hydrogel particles were added to Comparative Example 6, which was not subjected to hot melt granulation, and could not be formed into tablets during direct compression. Example 1-3 added 10-50% hydrogel, and after the hot melt granulation process, the tablet hardness was 11.4-16.7 kg / cm 2 The degree of friability is less than 1%, which meets the tablet qualification standards of the Chinese Pharmacopoeia.

[0085] The results in Table 3 show that, within the range of 10%-50% of the total mass of the composition, the higher the amount of hydrogel added, the higher the expansion rate of the composition; Example 3 and Comparative Example 6 show that tableting after hot-melt granulation of the hydrogel particles does not affect the expansion performance, and the tablets of the composition obtained after tableting the hydrogel particles in Examples 1-3 can maintain a long time after swelling in water, providing a long-term feeling of fullness.

[0086] The results in Table 4 show that the composition of the present invention can significantly improve the blood sugar inhibition rate, and the blood sugar inhibition rate of Example 2 is the highest, indicating that the blood sugar control components white kidney bean extract, mulberry leaf extract and α-lipoic acid have a significant effect on the blood sugar inhibition rate. The white kidney bean extract, mulberry leaf extract and α-lipoic acid in the blood sugar control components have the effects of preventing the hydrolysis and absorption of carbohydrates in the body, inhibiting the absorption of disaccharides by the small intestine, and promoting the efficiency of cells in utilizing glucose, thereby having the effect of lowering blood sugar.

[0087] The results in Table 5 show that the tablets of the composition prepared in Examples 1-3 have excellent weight loss effects on the subjects, among which Example 3 has the best weight loss effect, with a reduction in food intake of about 62.5% and the largest weight loss. The results of Example 3 and Comparative Examples 1-3 show that the hot-melt hydrogel particles of the satiety component have a significant effect on weight control, and the sugar-control components of white kidney bean extract, mulberry leaf extract and α-lipoic acid and the fat-reducing components of L-carnitine, medium-chain triglycerides and lotus leaf extract work synergistically with the hydrogel particles of the satiety component to further improve the weight loss effect.

[0088] The above embodiments are only preferred implementation modes of the present invention and are only used to explain the present invention rather than to limit the present invention. Any changes, substitutions, modifications, etc. made by those skilled in the art without departing from the spirit of the present invention should fall within the scope of protection of the present invention.

Claims

1. A satiety control sugar and fat reduction composition, characterized in that: The composition comprises hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, medium-chain triglyceride and lotus leaf extract; the composition is a tablet; The mass of the hot-melt hydrogel particles accounts for 30-80% of the total mass of the composition; the mass of the white kidney bean extract accounts for 5-30% of the total mass of the tablet composition; the mass of the mulberry leaf extract accounts for 2.5-5% of the total mass of the composition; the mass of the α-lipoic acid accounts for 2.5-5% of the total mass of the composition; the mass of the L-carnitine accounts for 5-20% of the total mass of the composition; the mass of the medium-chain triglyceride accounts for 3-7% of the total mass of the composition; the mass of the lotus leaf extract accounts for 2-3% of the total mass of the composition; The preparation process of the hot melt hydrogel particles comprises the following steps: (1) Preparation of hydrogel particles: crushing the hydrogel into 40-80 meshes to obtain hydrogel particles; (2) Hot melt granulation: Place the hydrogel particles, polyethylene glycol and sorbitol into a fluidized bed, heat at 80-110°C, and then cool to 15-30°C to obtain hot melt hydrogel particles.

2. A satiety control sugar and fat reduction composition according to claim 1, characterized in that: In step (1), the preparation method of the hydrogel is: dissolving sodium carboxymethyl cellulose and pectin in water, drying at 100-120° C. for 1-12 hours for physical cross-linking to obtain a hydrogel.

3. The satiety-controlling sugar-fat-reducing composition according to claim 1, characterized in that: In step (2), the polyethylene glycol is polyethylene glycol 4000 or polyethylene glycol 6000.

4. A satiety control sugar and fat reduction composition according to claim 1 or 3, characterized in that: In step (2), the mass ratio of hydrogel, polyethylene glycol and sorbitol is 10-50:5-10:10-20.

5. The satiety-controlling sugar-fat-reducing composition according to claim 1, characterized in that: The raw materials of the satiety control sugar and fat reduction composition include the following components by weight: 10-50 parts of hydrogel, 10-20 parts of sorbitol, 5-10 parts of polyethylene glycol, 5-30 parts of white kidney bean extract, 2.5-5 parts of mulberry leaf extract, 2.5-5 parts of alpha-lipoic acid, 5-20 parts of L-carnitine, 3-7 parts of medium chain triglycerides and 2-3 parts of lotus leaf extract.

6. The method for preparing the satiety-controlling sugar-fat-reducing composition according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) Preparation of hydrogel particles: crushing the hydrogel into 40-80 meshes to obtain hydrogel particles; (2) Hot melt granulation: hydrogel particles, polyethylene glycol and sorbitol are placed in a fluidized bed, heated at 80-110°C, and then cooled to 15-30°C to obtain hot melt hydrogel particles; (3) Mixing and tableting: The hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, lotus leaf extract and medium-chain triglycerides are homogeneously mixed and tableted to obtain a satiety, sugar-control and fat-reducing composition.

7. The preparation method according to claim 6, characterized in that: In step (2), the heating time is 20-60 minutes.

8. The preparation method according to claim 6, characterized in that: In step (2), during the heating process and the cooling process, the frequency of the fluidized bed fan is independently set to 20-50 Hz.

9. The preparation method according to claim 6, characterized in that: In step (3), the homogenous mixing is carried out in a mixer.

10. Use of the satiety-controlling sugar-fat-reducing composition according to any one of claims 1 to 5 or the satiety-controlling sugar-fat-reducing composition prepared by the preparation method according to any one of claims 6 to 9 in the preparation of foods, medicines or health products with stomach filling, weight control and blood sugar control effects.

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