A satiety, blood sugar control and fat reduction composition, its preparation method and application

Abstract

The present invention discloses a satiety sugar-controlling and fat-reducing composition and its preparation method and application, including hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, lotus leaf extract, medium-chain triglycerides, polyethylene glycol and sorbitol, and the composition is a tablet. The components cooperate with each other, can effectively adjust leptin levels, improve appetite, increase energy consumption, adjust fat metabolism, reduce fat accumulation, and increase fat consumption. At the same time, they 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 weight.

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 existing in the prior art, the purpose of the present invention is to provide a satiety, blood sugar control and fat reduction composition, its preparation method and application. Through the synergistic cooperation 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 simultaneously has three functions of providing satiety and reducing food intake, controlling blood sugar rise and burning fat, and can effectively reduce the weight of the taker. Through the preparation of hot-melt hydrogel particles, the problems of poor plasticity of hydrogel particles, difficulty in tableting and easy fragmentation, and poor mixing uniformity with other materials are overcome.

[0004] The purpose of the present invention is achieved at least by one of the following technical solutions:

[0005] The present invention provides a satiety, blood sugar control and fat reduction composition, including 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;

[0006] 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 triglycerides 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;

[0007] The preparation process of the hot-melt hydrogel particles includes the following steps:

[0008] (1) Preparation of hydrogel particles: Crush the hydrogel to 40-80 mesh to obtain hydrogel particles;

[0009] (2) Hot-melt granulation: Put 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.

[0010] Further, in step (1), the preparation method of the hydrogel is: Dissolve sodium carboxymethyl cellulose and pectin in water, and perform physical cross-linking by drying at 100-120 °C for 1-12 h to obtain a hydrogel.

[0011] Further, in step (2), the polyethylene glycol is polyethylene glycol 4000 or polyethylene glycol 6000.

[0012] Further, in step (2), the mass ratio of the hydrogel, polyethylene glycol and sorbitol is 10-50:5-10:10-20.

[0013] Further, in step (2), the mass ratio of the hydrogel, polyethylene glycol, and sorbitol is 30:10:20, 10:5:15, or 50:10:20.

[0014] Further, in step (2), the heating time is 20 - 60 min.

[0015] Further, in step (2), during the heating process and the cooling process, the fluidized bed fan frequency is independently set to 20 - 50 Hz.

[0016] Further, the raw materials of the satiety, blood sugar control, and fat reduction composition include the following components by weight:

[0017] 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 triglyceride, and 2 - 3 parts of lotus leaf extract.

[0018] Furthermore, the raw materials of the satiety, blood sugar control, and fat reduction composition include the following components by weight:

[0019] 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 triglyceride, and 2 - 3 parts of lotus leaf extract.

[0020] The present invention also provides a preparation method of a satiety, blood sugar control, and fat reduction composition as described in any one of the above, including the following steps:

[0021] (1) Preparation of hydrogel particles: The hydrogel is crushed to 40 - 80 mesh to obtain hydrogel particles;

[0022] (2) Hot melt granulation: The hydrogel particles, polyethylene glycol, and sorbitol are put into a fluidized bed, heated at 80 - 110°C, and then cooled to 15 - 30°C to obtain hot melt hydrogel particles;

[0023] (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 triglyceride are homogenously mixed and tableted to form a satiety, blood sugar control, and fat reduction composition.

[0024] Further, the raw materials of the satiety, blood sugar control, and fat reduction composition include the following components by weight:

[0025] 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 triglyceride, and 2 - 3 parts of lotus leaf extract.

[0026] Further, in step (2), the heating time is 20 - 60 min.

[0027] Further, in step (2), during the heating process and the cooling process, the fluidized bed fan frequency is independently set to 20 - 50 Hz.

[0028] Further, in step (3), the homogeneous mixing is carried out in a mixer.

[0029] The present invention also provides the application of the satiety, blood sugar control and fat reduction composition described in the foregoing technical solution or the satiety, blood sugar control and fat reduction composition prepared by the preparation method described in the foregoing technical solution in the preparation of foods, drugs or health products having the functions of gastric filling, weight control and blood sugar control.

[0030] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0031] (1) The satiety, blood 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 triglyceride and lotus leaf extract. Each component cooperates with each other and complements each other. The composition has the functions of satiety, blood sugar control and fat reduction, and can effectively adjust the leptin level, improve appetite, increase energy consumption, adjust the fat metabolism process, reduce fat accumulation, increase fat consumption. At the same time, it can also inhibit the activity of α-amylase, reduce the conversion of carbohydrates into fat, block the intake of calories and fat, and promote the peristalsis of the stomach and intestines, achieving the effect of significantly reducing the fat content and body fat percentage. Compared with weight loss products with only a single function of satiety, blood sugar control or fat reduction, the satiety, blood sugar control and fat reduction composition of the present invention can more effectively reduce the weight of the taker.

[0032] (2) In the preparation method of a satiety, blood sugar control and fat reduction composition provided by the present invention, the polymer polyethylene glycol with a relatively low viscous flow temperature (Tf) and the binder sorbitol are selected. After heating, they can be used as liquid binders without adding water or organic solvents and other binders. After granulation of the hydrogel particles, drying is not required, effectively overcoming the problems that the hydrogel particles have high hardness, poor plasticity, are easy to absorb water and expand and cannot be granulated by wet method, and can only directly mix and press tablets by reducing the content of hydrogel particles in the product or sacrificing hardness. Compared with other granulation methods, the components are more evenly mixed, simpler and more convenient, with low power consumption, saving production costs. The final product has no solvent residue, and at the same time improves the sensory experience of the taker for the composition. Detailed implementation mode

[0033] The present invention provides a satiety, blood sugar control and fat reduction composition, which 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 composition is a tablet;

[0034] 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 triglycerides 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;

[0035] The preparation process of the hot-melt hydrogel particles includes the following steps:

[0036] (1) Preparation of hydrogel particles: Crush the hydrogel to 40-80 mesh to obtain hydrogel particles;

[0037] (2) Hot-melt granulation: Put 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.

[0038] The hot-melt hydrogel particles in this composition can absorb water and swell, and can provide a sense of satiety after taking 4 g, reducing the intake of about 25-62.5% of the food by the human body; the white kidney bean extract can prevent the hydrolysis and digestion of the remaining ingested carbohydrates, and at the same time, directly discharge them through the 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-decomposing enzymes through alkaloid DNJ (1-deoxynojirimycin), thereby inhibiting the absorption of disaccharides in the small intestine; α-lipoic acid enhances the ability of glucose to enter cells by increasing the expression and activity of glucose transporter (GLUT4) in pancreatic islet cells, thereby reducing blood sugar levels; L-carnitine can increase the β-oxidation metabolism rate of fat and accelerate the consumption of fat by mitochondria in cells; the nuciferine in the 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 the accumulation of fat. The synergistic effect of multiple substances achieves the weight loss effect.

[0039] 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.

[0040] 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.

[0041] In some embodiments of the present invention, in step (2), the polyethylene glycol is polyethylene glycol 4000 or polyethylene glycol 6000.

[0042] 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.

[0043] In some embodiments of the present invention, in step (2), the heating time is 20-60 minutes.

[0044] 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.

[0045] 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.

[0046] 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:

[0047] (1) Preparation of hydrogel particles: The hydrogel is crushed to 40 - 80 mesh to obtain hydrogel particles;

[0048] (2) Hot melt granulation: The hydrogel particles, polyethylene glycol, and sorbitol are put into a fluidized bed and heated at 80 - 110 °C, and then cooled to 15 - 30 °C to obtain hot melt hydrogel particles;

[0049] (3) Mixing and tabletting: 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 homogenously mixed and tabletted to form a satiety, blood sugar control, and fat reduction composition.

[0050] In some embodiments of the present invention, based on parts by weight, the raw materials of the satiety, blood sugar control, and fat reduction composition include the following components: 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, based on parts by weight, the raw materials of the satiety, blood sugar control, and fat reduction composition include the following components: 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.

[0051] In some embodiments of the present invention, in step (2), the heating time is 20 - 60 min.

[0052] In some embodiments of the present invention, 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.

[0053] In some embodiments of the present invention, step (3) is specifically: 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 sequentially put in and homogenously mixed to obtain a satiety, blood sugar control, and fat reduction composition.

[0054] In some embodiments of the present invention, in step (3), the homogeneous mixing is carried out in a mixer.

[0055] The present invention also provides the application of the satiety, blood sugar control, and fat reduction composition described in the foregoing technical solution or the satiety, blood sugar control, and fat reduction composition prepared by the preparation method described in the foregoing technical solution in the preparation of foods, drugs, or health products having the functions of gastric filling, weight control, and blood sugar control.

[0056] The specific implementation of the present invention will be 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 for the processes not specifically described in detail below, those skilled in the art can implement or understand them with reference to the prior art. Reagents or instruments without indicating the manufacturer are regarded as conventional products that can be obtained through commercial purchase.

[0057] In the examples and comparative examples of the present invention, the white kidney bean extract was purchased from: Yunnan Tianbao Hua Bio-Resources Development Co., Ltd., model P40;

[0058] The mulberry leaf extract was purchased from: Huangshan Hualvyuan Biotechnology Co., Ltd., with a specification of 1%-2% DNJ content;

[0059] α-lipoic acid was purchased from: Hunan Yunbang Biotechnology Co., Ltd., specification: active ingredient 99%;

[0060] L-carnitine was purchased from: Chengdu Wanxiang Hongrun Biotechnology Co., Ltd., specification: active ingredient 99%;

[0061] Medium-chain triglycerides were purchased from: Xi'an Tianguangyuan Biotechnology Co., Ltd., specification: active ingredient 70%;

[0062] The lotus leaf extract was purchased from: Shaanxi Xintianyu Biotechnology Co., Ltd., model 10:1, with a lotus leaf alkaloid content of 2%-10%;

[0063] Polyethylene glycol 6000 was purchased from: Shandong Ruisheng Pharmaceutical Excipients Co., Ltd., models PEG-4000 and PEG-6000;

[0064] Sorbitol was purchased from: Zhejiang Huakang Pharmaceutical Co., Ltd., model HKSD40.

[0065] Example 1

[0066] A satiety, blood sugar control and fat reduction composition includes components 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 α-lipoic acid, 10 parts of L-carnitine, 7 parts of medium-chain triglycerides and 3 parts of lotus leaf extract.

[0067] The preparation method of the satiety, blood sugar control and fat reduction composition is as follows:

[0068] (1) Preparation of hydrogel particles: According to the method described in Example 2 of Patent CN115918889A, by weight, take 67 parts of sodium carboxymethylcellulose and 1 part of pectin, dissolve and stir with 1111 parts of water for 2 h, dry at a drying temperature of 110°C for 8 h, pulverize and sieve, and take 40-80 mesh hydrogel particles for standby;

[0069] (2)Hot melt granulation: Put 30 parts of 40 - 80 mesh hydrogel particles, 20 parts of sorbitol, and 10 parts of polyethylene glycol 4000 into a fluidized bed. Set the heating temperature at 80 °C, the fan frequency at 35 Hz, and the time at 60 min. Then stop heating, keep the fan frequency at 35 Hz, and wait for the temperature to drop to 15 - 30 °C to obtain hot melt hydrogel particles;

[0070] (3)Mixing and tabletting: 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 for mixing and tabletting.

[0071] Example 2

[0072] A satiety - promoting, blood - sugar - controlling, and fat - reducing composition includes components 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 α - lipoic acid, 20 parts of L - carnitine, 7 parts of medium - chain triglycerides, and 3 parts of lotus leaf extract.

[0073] The preparation method of the satiety - promoting, blood - sugar - controlling, and fat - reducing composition is as follows:

[0074] (1)Preparation of hydrogel particles: As described in Example 2 of Patent CN115918889A, by weight, take 67 parts of sodium carboxymethylcellulose and 1 part of pectin, dissolve and stir them with 1111 parts of water for 2 h, dry at a drying temperature of 110 °C for 8 h, crush and sieve, and reserve 40 - 80 mesh hydrogel particles;

[0075] (2)Hot melt granulation: Put 10 parts of 40 - 80 mesh hydrogel particles, 15 parts of sorbitol, and 5 parts of polyethylene glycol 6000 into a fluidized bed. Set the heating temperature at 110 °C, the fan frequency at 20 Hz, and the time at 20 min. Then stop heating, keep the fan frequency at 35 Hz, and wait for it to drop to 15 - 30 °C to obtain hot melt hydrogel particles;

[0076] (3)Mixing and tabletting: 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 for mixing and tabletting.

[0077] Example 3

[0078] A satiety - promoting, blood - sugar - controlling, and fat - reducing composition includes components 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 α - lipoic acid, 5 parts of L - carnitine, 3 parts of medium - chain triglycerides, and 2 parts of lotus leaf extract.

[0079] The preparation method of the satiety - promoting, blood - sugar - controlling, and fat - reducing composition is as follows:

[0080] (1) Preparation of hydrogel particles: According to the method described in Example 2 of Patent CN115918889A, by weight, take 67 parts of sodium carboxymethylcellulose and 1 part of pectin, dissolve and stir with 1111 parts of water for 2 h, dry at a drying temperature of 110 °C for 8 h, pulverize and sieve, and reserve 40-80 mesh hydrogel particles;

[0081] (2) Hot melt granulation: Put 50 parts of 40-80 mesh hydrogel particles, 20 parts of sorbitol and 10 parts of polyethylene glycol 6000 into a fluidized bed, set the heating temperature at 95 °C, the fan frequency at 50 Hz, and the time at 30 min; then stop heating, set the fan frequency at 35 Hz, and wait for it to cool to 15-30 °C to obtain hot melt hydrogel particles;

[0082] (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 triglyceride and 2 parts of lotus leaf extract into a mixer in sequence for mixing, and tablet into shape.

[0083] Comparative Example 1

[0084] Comparative Example 1 includes components 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 triglyceride and 2 parts of lotus leaf extract.

[0085] The preparation method is as follows:

[0086] Mixing and tableting: Put 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 triglyceride and 2 parts of lotus leaf extract into a mixer in sequence for mixing, and tablet into shape to obtain Comparative Example 1.

[0087] Comparative Example 1 lacks hydrogel particles compared with Example 3 and has no hot melt granulation process.

[0088] Comparative Example 2

[0089] Comparative Example 2 includes components by weight: 90 parts of hot melt hydrogel particles, 5 parts of L-carnitine, 3 parts of medium-chain triglyceride and 2 parts of lotus leaf extract.

[0090] The preparation method is as follows:

[0091] (1) Preparation of hydrogel particles: According to the method described in Example 2 of Patent CN115918889A, by weight, take 67 parts of sodium carboxymethylcellulose and 1 part of pectin, dissolve and stir with 1111 parts of water for 2 h, dry at a drying temperature of 110 °C for 8 h, pulverize and sieve, and reserve 40-80 mesh hydrogel particles;

[0092] (2) Hot melt granulation: Put 50 parts of 40 - 80 mesh hydrogel particles, 30 parts of sorbitol, and 10 parts of polyethylene glycol 6000 into a fluidized bed. Set the heating temperature at 95 °C, the fan frequency at 50 Hz, and the time at 30 min. Then stop heating, set the fan frequency at 35 Hz, and wait until the temperature drops to 15 - 30 °C to obtain hot melt hydrogel particles;

[0093] (3) Mixing and tableting: Put the hot melt hydrogel particles, 5 parts of L - carnitine, 3 parts of medium - chain triglycerides, and 2 parts of lotus leaf extract into a mixer in sequence for mixing, and then tablet - forming to obtain Comparative Example 2.

[0094] Comparative Example 2 lacks white kidney bean extract, mulberry leaf extract, and α - lipoic acid compared with Example 3.

[0095] Comparative Example 3

[0096] Comparative Example 3 includes components 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.

[0097] The preparation method is as follows:

[0098] (1) Preparation of hydrogel particles: As described in Example 2 of Patent CN115918889A, by weight, take 67 parts of sodium carboxymethylcellulose and 1 part of pectin, dissolve and stir them with 1111 parts of water for 2 h, dry at a drying temperature of 110 °C for 8 h, crush and sieve, and take 40 - 80 mesh hydrogel particles for standby;

[0099] (2) Hot melt granulation: Put 50 parts of 40 - 80 mesh hydrogel particles, 30 parts of sorbitol, and 10 parts of polyethylene glycol 6000 into a fluidized bed. Set the heating temperature at 95 °C, the fan frequency at 50 Hz, and the time at 30 min. Then stop heating, set the fan frequency at 35 Hz, and wait until the temperature drops to 15 - 30 °C to obtain hot melt hydrogel particles;

[0100] (3) Mixing and tableting: Put the 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 into a mixer in sequence for mixing, and then tablet - forming to obtain Comparative Example 3.

[0101] Comparative Example 3 lacks L - carnitine, medium - chain triglycerides, and lotus leaf extract compared with Example 3.

[0102] Comparative Example 4

[0103] Comparative Example 4 includes components 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.

[0104] The preparation method is as follows:

[0105] (1) Preparation of hydrogel particles: As described in Example 2 of Patent CN115918889A, by weight, take 67 parts of sodium carboxymethylcellulose and 1 part of pectin, dissolve and stir with 1111 parts of water for 2 h, dry at a drying temperature of 110 °C for 8 h, pulverize and sieve, and take 40-80 mesh hydrogel particles for standby;

[0106] (2) Mixing and tableting: Put 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 into a mixer in sequence for mixing, and tablet into shape to obtain Comparative Example 4.

[0107] Comparative Example 4 lacks the hot melt granulation process compared with Example 1.

[0108] Comparative Example 5

[0109] Comparative Example 5 includes components 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.

[0110] The preparation method is as follows:

[0111] (1) Preparation of hydrogel particles: As described in Example 2 of Patent CN115918889A, by weight, take 67 parts of sodium carboxymethylcellulose and 1 part of pectin, dissolve and stir with 1111 parts of water for 2 h, dry at a drying temperature of 110 °C for 8 h, pulverize and sieve, and take 40-80 mesh hydrogel particles for standby;

[0112] (2) Mixing and tableting: Put 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 into a mixer in sequence for mixing, and tablet into shape to obtain Comparative Example 5.

[0113] Comparative Example 5 lacks the hot melt granulation process compared with Example 2.

[0114] Comparative Example 6

[0115] Comparative Example 6 includes components 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 alpha-lipoic acid, 5 parts of L-carnitine, 3 parts of medium-chain triglycerides, and 2 parts of lotus leaf extract.

[0116] The preparation method is as follows:

[0117] (1) Preparation of hydrogel particles: As described in Example 2 of Patent CN115918889A, by weight, take 67 parts of sodium carboxymethylcellulose and 1 part of pectin, dissolve and stir with 1111 parts of water for 2 h, dry at a drying temperature of 110 °C for 8 h, pulverize and sieve, and take 40-80 mesh hydrogel particles for standby;

[0118] (2) Mixing and tableting: Put 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 alpha-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 for mixing, and tablet into shape to obtain Comparative Example 6.

[0119] Comparative Example 6 lacks the hot melt granulation process compared to Example 3.

[0120] Analysis and Conclusion

[0121] 1. Sample evaluation:

[0122] A. Uniformity test: Before tableting, perform content uniformity detection to ensure the uniform and stable content of the materials during the tableting process. Perform uniformity tests on Examples 1-3 respectively. Sample and detect the content of L-carnitine and nuciferine in the upper, middle, and lower parts of each sample. The addition amount of L-carnitine is 5-20%, and the addition amount of lotus leaf extract is 2-3%. Detect whether the homogeneous mixing of L-carnitine and lotus leaf extract is representative of the overall uniformity of the sample.

[0123] The sampling method is as follows: According to the sampling plan during the mixing stage in the "Technical Guidelines for the Study of Mixing Uniformity and In-Process Dosage Unit Uniformity of Chemical Oral Solid Preparations (Trial)": At least 10 sampling points are selected 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). At least 3 samples are taken at each sampling point, and the single-sample sampling amount is 10 g. If the relative standard deviation (RSD) ≤ 5.0%, the mixing uniformity of this example can be accepted.

[0124] The detection standards for active ingredients are as follows:

[0125] "Determination of Nuciferine in Export Health Foods" SN / T 4052-2014

[0126] National Food Safety Standard - Food Nutrient Fortifier - L-Carnitine

[0127] Tablet test: Tablet hardness and friability tests were conducted on the tablet samples of the compositions prepared in Examples 1-3 and the tablet samples prepared in Comparative Examples 4-6. The test methods are as follows:

[0128] Hardness determination: Take 10 test samples and sequentially place them into the test chamber of the YD-20KZ intelligent tablet hardness tester, then apply dynamic force for determination and record the data;

[0129] Friability determination: Test according to the "Tablet Friability Test Method" in the Chinese Pharmacopoeia. Take 10 samples, set the test parameters at 21 °C, 25 r / min, and a timing of 4 min, and use a four-function tablet tester for testing. Calculate the tablet friability according to formula (1). If the tablet cracks, it is judged unqualified.

[0130] Friability / % = [(m1 - m2) / m1] × 100%,

[0131] where m1 is the total weight of the pressed tablets before the test, and the unit of m1 is g;

[0132] m2 is the total weight of the pressed tablets after the test, and the unit of m2 is g. The tablet test results are shown in Table 1.

[0133] C. Composition swelling ratio test: Take 1 g of the tablet samples of the compositions prepared in Examples 1-3, Comparative Example 1, and Comparative Example 6 respectively and place them into a clean beaker containing 200 ml of simulated gastric juice (artificial gastric juice: water = 1:8), keep 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 is M1) and let them stand for 10 minutes, weigh M2, and calculate the water absorption ratio according to the following formula: The composition swelling ratio test results are shown in Table 2.

[0134] Swelling ratio = (M2 - M1 - 1) / 1.

[0135] where the units of M1 and M2 are both g.

[0136] Prepare artificial gastric juice according to the Chinese Pharmacopoeia 2010 edition. The method is as follows: For artificial gastric juice, take 16.4 ml of dilute hydrochloric acid, add about 800 ml of water and 10 g of pepsin, shake well, and then dilute with water to 1000 ml.

[0137] D. Postprandial blood glucose level test: Select 20 healthy adults in each group, 10 men and 10 women, aged 25 - 40 years old, and the BMI is 18.8 - 23.9 kg / m 2, without a history of diabetes (or impaired glucose tolerance), without other metabolic diseases, digestive system diseases, endocrine system diseases, mental diseases, etc.; without a history of allergy or intolerance to the test food, with a normal oral glucose tolerance test, regular diet, no recent gastrointestinal diseases and no taking of any medications, and passing the physical examination. The subjects were trained before the test and signed the informed consent form. After 22:00 on the night before the start of the experiment, food intake and water intake were stopped, and the blood glucose fluctuations after breakfast were measured.

[0138] Control group: The reference food white bread was eaten normally for breakfast;

[0139] Experimental group: 4 g of each example or comparative example sample of the experimental sample was eaten within 30 minutes before breakfast, and the reference food white bread was eaten normally for breakfast;

[0140] Using time as the abscissa and the blood glucose value at each time point - fasting blood glucose value as the ordinate, a blood glucose response curve was made, and the area under the curve (IAUC) above the fasting blood glucose level was calculated. Inhibition rate = (IAUC of reference food - IAUC of example) / IAUC of reference food * 100%. The test results of the postprandial blood glucose level are shown in Table 3.

[0141] For blood glucose testing, a Roche blood glucose meter was used. The specific operation for measuring fingertip blood glucose is as follows:

[0142] (1) Collect fingertip blood, discard the first drop, and measure fasting blood glucose continuously twice at an interval of 5 minutes and record;

[0143] (2) Drink 50 mL of water;

[0144] (3) After 5 minutes, eat white bread (calculated based on 50 g of carbohydrate intake) and 200 mL of water (completed within 5 minutes

[0145] eating);

[0146] (4) Collect fingertip blood to detect blood glucose and record (15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes,

[0147] 120 minutes after eating).

[0148] D. Population body weight test: 20 healthy adults were selected in each group, 10 men and 10 women, aged 23 - 50 years old, with a BMI of 24 - 30 kg / m 2 , without other metabolic diseases, digestive system diseases, endocrine system diseases, mental diseases, etc.; without a history of allergy or intolerance to the test food, no recent gastrointestinal diseases and no taking of any medications. The subjects were trained before the test and signed the informed consent form.

[0149] Control group 1: Have normal meals according to the recommended daily nutrient intake recommended by the Chinese Nutrition Society;

[0150] Control group 2: Have normal meals according to the recommended daily nutrient intake recommended by the Chinese Nutrition Society, and consume the composition provided in Example 2 of Chinese Patent CN202311296739.7 2 times a day, 4 g each time, within 30 minutes before meals;

[0151] Experimental group: Have normal meals according to the recommended daily nutrient intake recommended by the Chinese Nutrition Society, and consume the composition provided in each example or comparative example 2 times a day, 4 g each time, for 2 consecutive months. Check and record the body weight and eating conditions of each group of subjects, statistically analyze the results, calculate the average value, and the population body weight test results are shown in Table 4.

[0152] 2. Results and analysis:

[0153] Table 1 Test results of mixing uniformity

[0154]

[0155] Table 2 Test results of tabletting

[0156]

[0157] Table 3 Test results of long-term swelling ratio

[0158]

[0159] Table 4 Average inhibition rate results of each group

[0160]

[0161] Table 5 Body weight change results of each group

[0162]

[0163] According to the results calculated in Table 1, the relative standard deviations (RSD) of the carnitine and nuciferine content values in Example 1 are 0.77% and 2.20%; the relative standard deviations (RSD) of the carnitine and nuciferine content values in Example 2 are 0.40% and 2.33%; the relative standard deviations (RSD) of the carnitine and nuciferine content values in Example 3 are 1.17% and 2.75%. The relative standard deviation (RSD) < 5%, indicating good mixing uniformity of the materials.

[0164] Table 2 shows that in Comparative Examples 4-6, the hydrogel particles were not subjected to hot melt granulation and the direct compression method was used, resulting in a low hardness, and some could not be formed. Cracking occurred in the friability test, which did not meet the qualified standard of tablets in the Chinese Pharmacopoeia. Among them, 10% hydrogel particles were added in Comparative Example 5, without hot melt granulation, and the tablet hardness was low. In Comparative Example 6, 50% hydrogel particles were added, without hot melt granulation, and no tablets could be formed during direct compression. In Examples 1-3, 10-50% hydrogel was added. After the hot melt granulation process, the tablet hardness was between 11.4-16.7 kg / cm 2 and the friability was <1%, meeting the qualified standard of tablets in the Chinese Pharmacopoeia.

[0165] Table 3 shows that within the range of 10%-50% of the total mass of the composition by the mass of the hydrogel, the higher the addition amount of the hydrogel, the higher the swelling rate of the composition; Examples 3 and Comparative Example 6 show that hot melt granulation of the hydrogel particles does not affect the swelling performance during tableting. The tablets of the composition obtained by tableting the hydrogel particles in Examples 1-3 can maintain swelling for a long time when exposed to water, providing a long-term satiety feeling.

[0166] Table 4 shows that the composition of the present invention can significantly increase the blood glucose inhibition rate. The blood glucose inhibition rate of Example 2 is the highest, indicating that the blood glucose control components, white kidney bean extract, mulberry leaf extract and α-lipoic acid, have a significant effect on the blood glucose inhibition rate. The white kidney bean extract, mulberry leaf extract and α-lipoic acid in the blood glucose control components can prevent the hydrolysis and absorption of carbohydrates in the body, inhibit the absorption of disaccharides in the small intestine, and promote the efficiency of cells in using glucose, thereby achieving the effect of reducing blood glucose.

[0167] Table 5 shows that the tablets of the composition prepared in Examples 1-3 have excellent weight loss effects on the subjects. Among them, Example 3 has the best weight loss effect, with the food intake reduced by about 62.5% and the largest weight loss range. The results of Example 3 and Comparative Examples 1-3 show that the satiety component, hot melt hydrogel particles, has a significant effect on weight control. The blood glucose control components, white kidney bean extract, mulberry leaf extract and α-lipoic acid, and the fat reduction components, L-carnitine, medium-chain triglycerides and lotus leaf extract, synergistically act with the satiety component, hydrogel particles, to further improve the weight loss effect.

[0168] The above examples are only the preferred embodiments of the present invention, which are only used to explain the present invention, rather than limiting the present invention. Any changes, substitutions, modifications, etc. made by those skilled in the art without departing from the spirit and essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A method for preparing a satiety, sugar-control and fat-reducing composition, 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: placing hydrogel particles, polyethylene glycol and sorbitol in a fluidized bed, heating at 80-110°C, and then cooling to 15-30°C to obtain hot melt hydrogel particles; the heating time is 20-60 min; during the heating process and the cooling process, the fluidized bed fan frequency is independently set to 20-50 Hz; the polyethylene glycol is polyethylene glycol 4000 or polyethylene glycol 6000; the mass ratio of hydrogel, polyethylene glycol and sorbitol is 10-50:5-10:10-20; (3) Mixing and tableting: hot-melt hydrogel particles, white kidney bean extract, mulberry leaf extract, α-lipoic acid, L-carnitine, lotus leaf extract and medium-chain triglycerides are added in sequence, mixed homogeneously, and tableted to obtain a satiety, sugar-control and fat-reducing composition; The raw materials of the satiety, sugar-control and fat-reducing composition are the following components in parts 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; 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.

2. The method for preparing a satiety-controlling sugar-fat-reducing composition according to claim 1, characterized in that: In step (3), the homogenous mixing is carried out in a mixer.

3. A satiety control sugar and fat reduction composition prepared by the method for preparing a satiety control sugar and fat reduction composition according to any one of claims 1 to 2, characterized in that: The raw materials of the satiety control sugar and fat reduction composition are 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 raw materials of the satiety control sugar and fat reduction composition are the following components in parts 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; 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: placing hydrogel particles, polyethylene glycol and sorbitol in a fluidized bed, heating at 80-110°C, and then cooling to 15-30°C to obtain hot melt hydrogel particles; the polyethylene glycol is polyethylene glycol 4000 or polyethylene glycol 6000; the mass ratio of hydrogel, polyethylene glycol and sorbitol is 10-50:5-10:10-20; 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.

4. Use of the satiety, sugar-control and fat-reducing composition obtained by the preparation method of the satiety, sugar-control and fat-reducing composition according to any one of claims 1-2 or the satiety, sugar-control and fat-reducing composition according to claim 3 in the preparation of foods, medicines or health products with stomach filling, weight control and blood sugar control effects.

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