Tabletting candy with function of reducing blood sugar and blood fat and preparation method thereof

Abstract

The invention relates to the technical field of functional food, and discloses tabletted candies with functions of reducing blood sugar and blood lipid and a preparation method of the tabletted candies with the functions of reducing blood sugar and blood lipid, and the tabletted candies with the functions of reducing blood sugar and blood lipid comprise the following components in parts by weight: 25-40 parts of isomaltitol; 10 to 20 parts of maltodextrin; 10 to 20 parts of microcrystalline cellulose; 3-6 parts of ginseng powder; 3-5 parts of bitter gourd powder; 3-5 parts of mulberry leaf powder; 2-4 parts of rhizoma polygonati powder; 2-4 parts of sea buckthorn powder; 2 to 4 parts of wheat oligopeptide; 2 to 4 parts of corn polypeptide; 2 to 4 parts of collagen peptide; 2 to 4 parts of albumin peptide; 1-3 parts of a saussurea involucrate culture; and 0.05 to 0.2 part of vitamin B1. Through the synergistic compatibility of the ginseng powder and the mulberry leaf powder, the proportion of small molecule peptides is optimized, and the multi-target effect of blood glucose regulation and control, long-term stable activity release and enhanced health intervention effect are realized by adopting a composite structure design and precise raw material screening.

Description

Technical Field

[0001] The present invention relates to the technical field of functional foods, and specifically to a compressed candy with hypoglycemic and lipid-lowering functions and a preparation method thereof. Background Art

[0002] With the acceleration of the modern people's life rhythm and the imbalance of diet structure, blood glucose abnormalities and related metabolic health problems show a trend of getting younger and becoming normal. People's demand for daily ingestible and portable functional nutrition products is increasing continuously. In particular, natural health products with multiple functions such as regulating blood glucose, enhancing physical strength, and maintaining metabolic balance are more popular. Compressed candies have gradually become a popular form of functional ingredient carriers due to their good taste, easy portability, and friendly taking methods.

[0003] In the prior art, some functional compressed candies have indeed made certain attempts in controlling blood glucose and regulating energy. For example, products developed using bitter gourd, onion extracts, or some dietary fiber raw materials can delay the absorption of sugars or improve the intestinal flora to a certain extent; there are also products that enhance the basal metabolic ability and satiety by adding protein peptides. One advantage of such products is that they have natural ingredients, are convenient to take, and have a certain flavor basis, making them easy to be accepted by the market.

[0004] However, there are still some deficiencies in the prior art; firstly, most of the ingredient combinations lack targeted design, and there is insufficient coordination among multiple functional substances, resulting in a single action path and a weak regulatory mechanism; secondly, there is a common problem of out-of-control dosage in the addition of polypeptides. A large amount is prone to aggregation and precipitation, forming a precipitation layer, seriously affecting the release of active ingredients. This situation is mostly ignored, resulting in unqualified product appearance and stability; in addition, the currently widely used method of adding free-state functional substances does not consider the protection of ingredients in the compressed tablet system, making easily degradable substances such as ginsenosides and 1-DNJ rapidly lose during storage, and the function attenuation is obvious; even more, for plant materials such as mulberry leaves with specific target functions, only the original powder or extract is simply added without precise release design of key components, making it difficult to form a substantial intervention effect. Summary of the Invention

[0005] Aiming at the deficiencies of the prior art, the present invention provides a compressed candy with hypoglycemic and lipid-lowering functions and a preparation method thereof, which solves the problems of poor coordination of functional components, unstable activity, and weak targeting in existing compressed candies.

[0006] To achieve the above objectives, the present invention is realized through the following technical solutions: A compressed candy with hypoglycemic and lipid-lowering functions, the compressed candy comprising the following components in parts by weight: Isomaltitol: 25 - 40 parts. Isomaltitol is a natural low - calorie sweetener widely used in sugar - reduced and diabetic foods. Its main components have a low glycemic index (GI). By directly replacing traditional sugars, isomaltitol reduces sugar intake, thus helping to control blood sugar levels. At the same time, isomaltitol can also inhibit fat accumulation, thus playing a role in reducing lipid levels; Maltodextrin: 10 - 20 parts. Maltodextrin is a low - molecular - weight carbohydrate made from starch through hydrolysis reactions. It is commonly used as a filler and thickener, which can improve the taste and stability of products. Its metabolism in the body is slow and it does not cause rapid blood sugar elevation. It can provide stable energy for the body, helping to avoid post - meal hyperglycemia and improving lipid - lowering effects; Microcrystalline cellulose: 10 - 20 parts. Microcrystalline cellulose is an extract of natural plant fibers and is widely used in the formulations of pharmaceuticals and health foods. Microcrystalline cellulose can promote intestinal peristalsis, help improve constipation, and has a good intestinal detoxification effect. By increasing the dietary fiber content in the intestine, it helps to lower blood sugar and lipid levels and helps to control post - meal blood sugar levels; Ginseng powder: 3 - 6 parts. Ginseng powder contains rich saponin compounds. Among them, ginsenosides can promote insulin secretion, enhance the effect of insulin, thus improving glucose metabolism and lowering blood sugar levels. The active ingredients in ginseng powder can also promote fat metabolism, reduce blood lipids, especially total cholesterol and triglycerides, thus achieving the effect of lipid reduction; Bitter melon powder: 3 - 5 parts. Bitter melon powder is rich in ingredients such as momordicin, vitamin C, and minerals. Momordicin in bitter melon has a blood - sugar - lowering effect and can promote insulin secretion and sugar metabolism. The active ingredients in bitter melon powder can help control diabetes by regulating insulin resistance and lowering blood sugar levels. At the same time, bitter melon powder can also inhibit fat synthesis and increase fat oxidation, helping to reduce lipid levels; Mulberry leaf powder: 3 - 5 parts. Mulberry leaf powder is a plant powder extracted from mulberry leaves and is rich in flavonoids, vitamins, and minerals. The flavonoids in mulberry leaves can effectively regulate blood sugar levels, have strong antioxidant effects, can reduce free radicals in the body, and protect pancreatic cells from damage. Mulberry leaf powder can also inhibit sugar absorption, improve insulin sensitivity, and lower blood lipids, especially having a significant lipid - lowering effect on triglycerides; Polygonatum sibiricum powder: 2 - 4 parts. Polygonatum sibiricum powder is a powder extracted from the Polygonatum sibiricum plant. Polygonatum sibiricum has the effects of improving fat metabolism and lowering blood sugar. It can enhance the effect of insulin and inhibit fat synthesis, thus lowering blood sugar and blood lipids. The active ingredients in Polygonatum sibiricum powder can help regulate the body's sugar and lipid metabolism and keep blood sugar and blood lipids at normal levels; Sea buckthorn powder: 2 - 4 parts. Sea buckthorn powder is rich in various vitamins, amino acids and fatty acids. The bioactive components in sea buckthorn powder can improve fat metabolism, lower blood lipids, especially help reduce triglycerides and total cholesterol in the body. In addition, sea buckthorn can also promote the secretion of insulin, help control blood sugar, and thus play a synergistic role in reducing blood sugar and blood lipids; Wheat oligopeptide: 2 - 4 parts and corn oligopeptide: 2 - 4 parts. Wheat oligopeptide and corn oligopeptide are peptide substances obtained by hydrolysis, with good biological activity. Wheat oligopeptide and corn oligopeptide can help lower blood sugar by enhancing the action of insulin. In addition, they can also promote fat metabolism, reduce fat deposition, and lower blood lipids, especially having an obvious lowering effect on low-density lipoprotein cholesterol (LDL-C); Collagen peptide: 2 - 4 parts and albumin peptide: 2 - 4 parts. Collagen peptide and albumin peptide have good applications in enhancing skin elasticity, bone health, etc. Collagen peptide and albumin peptide can help regulate blood sugar and blood lipids by enhancing protein synthesis in the body, contribute to improving insulin sensitivity, and improving the process of sugar metabolism, thus playing a synergistic role in reducing blood sugar and blood lipids; Saussurea involucrata culture: 1 - 3 parts. Saussurea involucrata culture is rich in various bioactive substances, including steroid compounds, polysaccharides and amino acids, etc. Saussurea involucrata culture has anti-diabetic and anti-hyperlipidemic effects. It helps reduce blood sugar and blood lipids by regulating fat metabolism and improving insulin sensitivity. In addition, the polysaccharide component in Saussurea involucrata can inhibit hepatic gluconeogenesis and fat synthesis, thus controlling blood sugar and blood lipid levels; Vitamin B1: 0.05 - 0.2 parts and vitamin B2: 0.05 - 0.2 parts. Vitamin B1 and B2 are important water-soluble vitamins, which can promote the decomposition and utilization of carbohydrates, reduce the excessive accumulation of glycogen reserves, help control blood sugar, and can also improve the fat metabolism process, thus playing a role in reducing blood lipids; Magnesium stearate: 0.8 - 1.6 parts. Magnesium stearate is added as a lubricant. It can form a uniform lubricating film on the surface of the granules, reduce the friction coefficient between the granules and the adhesion between the granules and the mold, thus significantly improving the fluidity of the granules in the mold cavity and making the tableting process smoother; Erythritol: 10 - 20 parts. Erythritol is a natural sugar alcohol sweetener. Erythritol can be used as a sweetener to replace traditional sugars, but it is not absorbed by the human body, so it will not cause blood sugar fluctuations. It not only helps reduce the energy density of food, but also has a certain blood lipid-lowering effect, can promote the metabolism of body fat, and reduce the accumulation of body fat.

[0007] Preferably, the total content of ginsenosides in the ginseng powder is ≥10%. Ginsenosides are one of the main active ingredients in ginseng and have various biological activities. Therefore, determining its content ≥10% can ensure the effectiveness and stability of the product. Using ginseng powder of this standard in the formula can not only provide sufficient active ingredients but also ensure the exertion of the hypoglycemic and lipid-lowering functions.

[0008] Preferably, the mulberry leaf powder contains ≥0.3% of 1-deoxynojirimycin and the moisture content is ≤8%. 1-Deoxynojirimycin is a natural flavonoid compound that can effectively inhibit the activity of α-glucosidase. α-Glucosidase is a small intestinal enzyme that can break down carbohydrates into glucose. By inhibiting the activity of this enzyme, 1-deoxynojirimycin can delay the digestion and absorption of sugars, reduce the increase in postprandial blood glucose, and thus play a role in lowering blood glucose. The moisture content ≤8% helps maintain its long-term stability, avoid mildew or the growth of other microorganisms caused by moisture, and ensure that the product does not deteriorate during storage. Excessive moisture will not only affect the fluidity of the powder but also may cause the degradation of ingredients, reduce their biological activity, and affect the hypoglycemic and lipid-lowering effects. In addition, low-moisture mulberry leaf powder can better mix with other powder ingredients (such as ginseng powder, bitter melon powder, etc.) to ensure the uniformity and stability of the product.

[0009] Preferably, the molecular weight of the wheat oligopeptide is 300 - 800 Da, and the molecular weight of the corn oligopeptide is 200 - 600 Da. The wheat oligopeptide and the corn oligopeptide are absorbed relatively quickly in the body. Peptide substances with smaller molecular weights can more easily cross the intestinal wall and enter the blood circulation, thus quickly playing the role of lowering blood sugar and blood lipid in the body. Therefore, this molecular weight range helps to maximize their biological activity and clinical efficacy.

[0010] Preferably, the present invention also provides a preparation method for preparing a compressed candy with hypoglycemic and lipid-lowering functions, including the following steps: S1. Raw material pretreatment: drying, sieving, and uniformly mixing the raw materials; S2. Dry granulation: pressing the mixed raw materials into strips through a roller press dry granulation equipment and then pulverizing; S3. Lubrication and mixing: uniformly mixing the dry granules with the lubricant magnesium stearate; S4. Tableting and packaging: tableting the granules and then packaging and storing them in an aluminum-plastic blister or bottled manner.

[0011] Preferably, the raw material pretreatment step includes: Ginseng powder, bitter gourd powder, mulberry leaf powder, polygonatum sibiricum powder, seabuckthorn powder, and snow lotus extract were respectively dried by hot air at 60 °C for 4 - 6 hours to reduce the moisture content to ≤8%. Hot air drying not only reduces the moisture content of the plant powder but also ensures the stability of its active ingredients. Excessive moisture may cause the degradation or deterioration of active ingredients in the plant powder, such as ginsenosides and 1-deoxynojirimycin, thus affecting the blood sugar and lipid-lowering effects. Therefore, controlling the moisture content at ≤8% helps to extend the shelf life and maintain the biological activity of the plant powder; Sieving was carried out successively using 80-mesh and 100-mesh double-stage sieves to remove coarse particles. The sieving operation ensured the fineness of the plant powder, avoided the presence of large particles, and thus improved the uniformity in the subsequent mixing and tableting processes. Fine particles can be better absorbed in the gastrointestinal tract, improving the bioavailability of the ingredients. In addition, removing coarse particles can prevent quality instability caused by uneven particle sizes during tableting; The above-filtered materials, wheat oligopeptide, corn oligopeptide, collagen peptide, albumin peptide, microcrystalline cellulose, maltodextrin, isomaltulose, and erythritol were mixed according to the formula ratio and stirred in a horizontal mixer at 60 - 100 rpm for 10 - 15 minutes. Thoroughly stirring all the raw materials in the horizontal mixer is a key step to ensure the uniform distribution of all active ingredients (such as wheat oligopeptide, corn oligopeptide, and other peptides, plant powder, etc.). Uniform mixing can not only make the blood sugar and lipid-lowering ingredients contained in each candy consistent but also ensure the stable consistency of the taste, appearance, and blood sugar and lipid-lowering effects of each candy.

[0012] Preferably, the dry granulation step includes: The obtained mixture was fed into a roller press dry granulator. The roller press pressure was set at 5 - 8 MPa, and the roller gap was controlled at 0.6 - 1.0 mm to press into strip-shaped or sheet-shaped compacts. The set roller press pressure ensured the degree of compaction of the granules, which could not only improve the density of the granules, prevent the material from loosening, but also ensure good fluidity of the material in the subsequent grinding process. The control of the roller gap ensured the uniformity of the compacts, avoided the appearance of too large or too small particles, and was conducive to subsequent grinding and sieving operations; The compacts were fed into a high-speed rotary knife mill for grinding. The rotation speed was set at 800 - 1200 rpm, and the particle size of the fragments was controlled at 0.2 - 1.0 mm. The high rotation speed (800 - 1200 rpm) and cutting action of the high-speed rotary knife mill quickly ground the strip-shaped or sheet-shaped compacts into small particles. The setting of the rotation speed ensured the high efficiency of the grinding process and would not cause the particles to be too fine to affect the fluidity. Controlling the particle size at 0.2 - 1.0 mm ensured that the particles could flow uniformly during tableting, avoiding difficulties in tableting due to too large particles or uneven hardness of the tableting candies due to too small particles; The crushed material is screened through a 0.8 mm sieve to obtain uniform particles. Screening helps improve the fluidity of the particles, ensuring that the particles can uniformly fill the mold during the subsequent tableting process, thereby guaranteeing the uniformity and quality of the final product.

[0013] Preferably, the lubrication mixing step includes: Magnesium stearate is added to the particles obtained by dry granulation. The addition amount of magnesium stearate is 0.5 - 1.0% of the total formula mass. Magnesium stearate is a commonly used lubricant, and its main function is to reduce the friction between particles and improve the fluidity of the particles. During the tableting process, magnesium stearate can form a lubricating film on the surface of the particles, preventing the particles from adhering to the tableting machine mold, thus ensuring the smooth operation of the tableting machine. The addition amount of magnesium stearate between 0.5 - 1.0% can provide sufficient lubrication without affecting the tableting effect and functionality of the final product; Mix in a horizontal mixer for 3 - 5 minutes, and control the stirring speed at 50 - 80 rpm. The mixing time of 3 - 5 minutes and the stirring speed of 50 - 80 rpm are set to help ensure that magnesium stearate is evenly distributed on the surface of the particles. Too short a mixing time may result in insufficient distribution of the lubricant, while too long a time may cause the particles to be affected by excessive mechanical force, affecting the structure of the particles. Therefore, by optimizing the mixing time and stirring speed, the best lubrication effect can be achieved without damaging the particle morphology or causing excessive friction.

[0014] Preferably, the tableting and packaging include: The lubricated particles are fed into a rotary tableting machine to be pressed into tablet candies. The mold diameter is 8 - 10 mm, and the weight of the tablet candies is controlled at 0.9 - 1.2 g / tablet. The rotary tableting machine presses the lubricated particles into shape through uniform pressure. The diameter of the mold is set at 8 - 10 mm and the weight of each candy is controlled at 0.9 - 1.2 g, which can ensure that the weight and size of each candy are within the specified range, ensuring that the tablet candies have a moderate taste; The tableting pressure is set at 30 - 50 kN, the hardness of the pressed tablets is 60 - 100 N, and the friability is less than 1.0%. The hardness within the range of 60 - 100 N can ensure that the candies are not easily broken during use and can also maintain stability during packaging and transportation. In addition, the friability is controlled below 1.0%, further ensuring the stability of the candies and preventing them from being easily damaged even during packaging or transportation; The finished tablets are packaged in aluminum-plastic blister packs. Each blister pack contains 10 tablets and 0.5 - 1 g of silica gel desiccant. Aluminum-plastic blister packaging is a commonly used method for packaging pharmaceuticals and food products, which can effectively protect the candies from moisture, air, and light. Through aluminum-plastic blister packaging, the candies are physically protected effectively. The addition of silica gel desiccant can keep the humidity inside the package at a relatively low level; After packaging, it is stored in a dry environment with humidity ≤ 60% and temperature ≤ 25°C. Controlling the humidity in an environment with humidity ≤ 60% can prevent the candies from sticking, deforming, or degrading after absorbing moisture, and maintain the stability of the candies. Controlling the temperature below 25°C is to prevent high temperature from causing thermal degradation of the active ingredients in the candies (such as wheat oligopeptides, corn oligopeptides, etc.), ensuring that the functional ingredients in the candies are not lost during storage and maintaining their hypoglycemic and lipid-lowering effects.

[0015] The present invention provides a compressed candy with hypoglycemic and lipid-lowering functions and its preparation method. It has the following beneficial effects: 1. The present invention adopts the technical scheme of synergistic compatibility of ginseng powder and mulberry leaf powder, achieving a functional improvement effect of multi-target joint regulation of blood glucose level. Compared with the compressed candies with a single functional ingredient in the prior art, which only act on a certain metabolic pathway, it solves the deficiencies of their single action and unstable regulation effect.

[0016] 2. The present invention optimizes the synergistic absorption and storage stability among components by regulating the ratio and molecular weight range of small molecule peptides. Compared with the traditional compressed candy structure with high-concentration protein or peptide addition, it overcomes the problem of attenuation of active ingredients caused by aggregation and precipitation, ensuring long-term functional release.

[0017] 3. The present invention adopts an active ingredient - carrier composite structure design, strengthening the structural stability of functional components such as ginsenosides and 1-DNJ in the system. Different from the unstable design in the prior art where the components are freely dispersed and easily degraded, it significantly improves the active retention rate and use safety of the product during the shelf life.

[0018] 4. The present invention introduces a raw material screening strategy with mulberry leaf powder as the core of functional positioning, effectively improving the blood glucose regulation targeting of the compressed candy. Compared with the traditional product development mode mainly guided by flavor or sensory evaluation, it solves the problems of lack of core action mechanism and fuzzy functional attributes, and has stronger health intervention value. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a flowchart of the method of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0020] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings in the specification of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0021] Please refer to the attached Figure 1 : Example 1: Raw material composition (parts by weight): Isomaltitol: 30; Maltodextrin: 15; Microcrystalline cellulose: 15; Ginseng powder (saponin ≥ 10%): 5; Bitter melon powder: 4; Mulberry leaf powder (moisture ≤ 8%, 1-DNJ ≥ 0.3%): 4; Polygonatum sibiricum powder: 3; Sea buckthorn powder: 3; Wheat oligopeptide (300–800Da): 3; Corn oligopeptide (200–600Da): 3; Collagen peptide: 3; Albumin peptide: 3; Saussurea involucrata culture: 2; Vitamin B1: 0.1; Vitamin B2: 0.1; Magnesium stearate: 1.0 (about 0.8% of the total mass); Erythritol: 15.

[0022] Preparation process: 1. Raw material pretreatment: All plant powders are dried in hot air at 60°C for 5 hours until the moisture ≤ 8%, and successively passed through 80-mesh and 100-mesh sieves to remove coarse particles; they are mixed with the remaining components in a horizontal mixer at 80 rpm for 12 minutes.

[0023] 2. Dry granulation: A roller press dry granulator is used, with a roller press pressure of 6.5 MPa and a roller gap of 0.8 mm; the pressed material enters a rotary knife mill with a rotational speed of 1000 rpm, and the particle size is controlled to be 0.4 mm, and it is screened through a 0.8-mm sieve.

[0024] 3. Lubrication and mixing: Magnesium stearate (accounting for 0.8% of the total formula) is added and stirred in a horizontal mixer at 60 rpm for 4 minutes.

[0025] 4. Tableting and packaging: The mold diameter is 9 mm, the tablet weight is 1.0 g, the pressure is set to 40 kN, the tablet hardness is 80 N, and the friability is 0.5%; it is packaged using aluminum-plastic blister packaging, with 10 tablets per board, equipped with 0.5 g of silica gel desiccant, and stored at 25°C and humidity ≤ 60%.

[0026] Example 2: Raw material composition (parts by weight): Isomaltitol: 35; Maltodextrin: 12; Microcrystalline cellulose: 18; Ginseng powder: 6; Bitter melon powder: 3; Mulberry leaf powder: 3.5; Polygonatum sibiricum powder: 2.5; Sea buckthorn powder: 2.5; Wheat oligopeptide: 2.5; Corn oligopeptide: 2.5; Collagen peptide: 2; Albumin peptide: 2.5; Saussurea involucrata culture: 2; Vitamin B1: 0.15; Vitamin B2: 0.15; Magnesium stearate: 1.2 (0.9% of the total mass).

[0027] Erythritol: 18.

[0028] Preparation process: 1. Raw material pretreatment: After drying the raw materials for 4 hours and screening, mix them in a horizontal mixer at 90 rpm for 13 minutes; 2. Dry granulation: Roller pressing pressure 7 MPa, gap 0.9 mm; Crushing speed 1200 rpm, screening particle size 0.3 - 0.8 mm; 3. Lubrication and mixing: Stirring speed 70 rpm, time 5 minutes; 4. Tabletting and packaging: Tablet weight 1.1 g, die diameter 10 mm, tabletting pressure 45 kN, hardness 90 N, friability 0.7%; Blister packaging, 10 tablets per board, containing 1 g of desiccant, stored in low-temperature drying.

[0029] Example 3: Raw material composition (parts by weight): Isomaltitol: 40; Maltodextrin: 10; Microcrystalline cellulose: 20; Ginseng powder: 4; Bitter melon powder: 5; Mulberry leaf powder: 5; Polygonatum sibiricum powder: 4; Sea buckthorn powder: 4; Wheat oligopeptide: 4; Corn oligopeptide: 4; Collagen peptide: 4; Albumin peptide: 4; Saussurea involucrata culture: 3; Vitamin B1: 0.2; Vitamin B2: 0.2; Magnesium stearate: 1.6 (1.0% of the total mass); Erythritol: 20.

[0030] Preparation process: 1. Raw material pretreatment: After drying the raw materials for 6 hours and screening, mix them in a horizontal mixer at 100 rpm for 15 minutes; 2. Dry granulation: Roller pressing pressure 8 MPa, roller gap 0.6 mm; Crushing speed 800 rpm, particle size control 0.2 mm; 3. Lubrication and mixing: Stir at 50 rpm for 3 minutes; 4. Tabletting and packaging: Tablet weight 1.2 g, die diameter 10 mm, tabletting pressure 50 kN, hardness 100 N, friability 0.3%; Blister packaging contains 10 tablets, with 1 g of desiccant, storage environment temperature ≤ 25 °C, humidity ≤ 60%.

[0031] Comparative example 1: Compared with Example 1, the difference is that the ginseng powder in the formula is removed, and the rest are the same.

[0032] Comparative Example 2: Compared with Example 1, the difference lies in that during dry granulation, roller compaction was not performed, and only the mixture was directly crushed, and the rest were the same.

[0033] Comparative Example 3: Compared with Example 2, the difference lies in that mulberry leaf powder was replaced with aloe powder, and the rest were the same.

[0034] Comparative Example 4: Compared with Example 2, the difference lies in that magnesium stearate was not added during lubricating mixing, and the rest were the same.

[0035] Comparative Example 5: Compared with Example 3, the difference lies in that the dosage of corn oligopeptide was increased to 6 parts, and the rest were the same.

[0036] Comparative Example 6: Compared with Example 3, the difference lies in that the pressure during the tableting process was only set to 20 kN, and the rest were the same.

[0037] Test Example 1: I. Experimental Purpose: To evaluate the performance differences of the tablets obtained under different formulations or process conditions in terms of hardness, friability, particle fluidity, etc.

[0038] II. Experimental Samples: Examples 1, 2, and 3 (complete formulations and processes): Comparative Example 2 (without roller compaction granulation); Comparative Example 4 (without adding magnesium stearate); Comparative Example 6 (too low tableting pressure).

[0039] III. Experimental Equipment: Medical tablet hardness tester; Tablet friability tester; Fluidity test device (angle of repose measuring instrument, flow rate funnel, electronic balance).

[0040] IV. Experimental Procedures: Sampling: After each sample was prepared, 100 candies were randomly selected for testing.

[0041] Hardness Test: Randomly select 10 tablets from each group of samples for hardness determination; Use the hardness tester to measure the crushing force of each tablet, with the unit of N; Record the maximum value, minimum value, and average value.

[0042] Friability Test: Take 20 tablets from each group and place them in the friability tester and rotate for 100 times; Take out the samples and weigh them, and calculate the weight loss rate, that is, the friability rate (%).

[0043] Particle flowability test (before tableting): Measure the angle of repose after natural accumulation of the particles; Use a flow rate funnel device to measure the time (seconds) required for 100 g of particles to flow out; Record the flowability difference (experimental results are shown in Table 1).

[0044] Table 1 Test results of mechanical properties of different sample tablets It can be seen from Table 1 that: In Comparative Example 2, without roller compaction granulation, the particles were loose and the structure was uneven, resulting in insufficient tablet compaction, low apparent hardness and poor consistency. This phenomenon is consistent with the mechanism of dry granulation in forming dense and structurally stable particles: roller compaction causes plastic deformation and preliminary bonding of the powder, which helps with secondary compaction during tableting. Therefore, the lack of the roller compaction step will seriously weaken the structural stability of the tablets, resulting in poor hardness, fragility and unsuitability for industrial production of the finished products.

[0045] The lubricating effect of magnesium stearate is also crucial for improving the mechanical properties of the finished products. In the experiment, Comparative Example 4 showed a significant increase in friability rate and uneven hardness. The fundamental reason is the lack of lubricating film coverage, increased friction between particles, stress concentration during tableting, resulting in microcracks and even corner breakage of the tablets. This verifies the theoretical mechanism of lubricants in reducing friction between particles and between particles and die wall in the tableting system, and improving the forming integrity and tableting efficiency. Especially on the premise that the particle structure has been finalized, the presence or absence of the lubricating layer becomes a determining factor for the feasibility of tableting.

[0046] The role of tableting pressure is shown as a key control point for the final density of the structure. In Comparative Example 6, the pressure setting was lower than the reasonable range. Although the particle structure and lubricant were both available, sufficient compaction could not be achieved, resulting in insufficient tablet strength. This is consistent with the "compaction - bonding - holding" three-stage theory of the tableting process: only under the condition of reaching the necessary pressure, a firm plastic bonding network will be formed between the internal particles of the tablets. Therefore, even with sufficient pretreatment, insufficient pressure will lead to a significant decrease in the overall strength, thus verifying the importance and irreplaceability of energy input during the tableting stage.

[0047] Test Example 2: I. Experimental purpose: To evaluate the effects of different granulation states, lubrication conditions and tableting pressures on the continuity and stability of the tableting process and the forming integrity of the products.

[0048] II. Experimental samples: Examples 1, 2, 3 (as process controls, with complete structures); Comparative Example 2 (roller compaction granulation cancelled); Comparative Example 4 (without magnesium stearate); Comparative Example 6 (too low tableting pressure).

[0049] III. Experimental equipment: Automatic rotary tablet press (9 mm and 10 mm dies); High-definition camera to record the forming process; Manual defect counting tool; Finished product inspection tools (vernier caliper, crack detection lamp).

[0050] IV. Experimental procedures: Feeding preparation: After each sample was prepared, 1000 g of granules were weighed separately for tableting operations; The set number of tablets for each group was 1000.

[0051] Tableting operations: Continuous tableting was carried out under the same machine type and speed setting; Record the tableting time of each group, and whether problems such as shutdown, material jamming, sticking to the mold, and broken tablets occurred.

[0052] Finished product defect detection: Check the appearance of the 1000 formed samples one by one; Count the number of defective tablets such as edge chipping, cracking, sticking, and abnormal tablet weight; Calculation of tableting forming rate: ; The experimental results are shown in Table 2.

[0053] Table 2 Test results of tableting forming adaptability of different samples It can be seen from Table 2 that: In the examples, through roller compaction dry granulation, the mixed powder undergoes plastic deformation and preliminary bonding under the action of roller pressure to form compacted granules with a certain hardness and structural strength. This structure helps the granules to flow rapidly and fill evenly in the die cavity of the tablet press. In Comparative Example 2, there was no roller compaction, the granules were loose and irregular in shape, and were prone to accumulation and bridging during the flow process, resulting in material jamming, insufficient filling or offset, thus causing phenomena such as sticking to the mold and edge chipping, significantly reducing the controllability and forming rate of tableting.

[0054] In the examples, the surface of the granules was coated with a lubricating film, which can effectively reduce the frictional resistance between the metal mold and the granules during tableting, improving the flow smoothness of granule filling and the demolding efficiency. In Comparative Example 4, no lubricant was added, and the granules generated a large adhesion force after being compacted in the mold, especially causing the mold temperature to rise during high-speed rotary tableting, further exacerbating the problem of sticking to the mold, resulting in tablet deformation and corner chipping, and finally a decrease in the forming rate. Insufficient lubrication is also likely to exacerbate stress concentration, leading to the generation of microcracks at the edges.

[0055] In Example 3, pressure promotes the full contact and interlocking of particles in the mold cavity, and a stable mechanical structure is formed through compressive stress. In Comparative Example 6, the set pressure is significantly lower. Although the particle structure and lubrication conditions are relatively good, it is not sufficient to reach the critical point of compaction and bonding between particles, resulting in loose tablets and even fracture when the mold is withdrawn.

[0056] Test Example Three: I. Experimental Purpose: To evaluate the effects of different formulation changes on the content and stability of functional ingredients.

[0057] II. Experimental Samples: Examples 1, 2, and 3 (containing key active components); Comparative Example 1 (removing ginseng powder), 3 (replacing mulberry leaf powder), 5 (excessive corn oligopeptide).

[0058] III. Test Methods: Quantitative Analysis of Ingredients: Determine the contents of ginsenosides, 1-deoxynojirimycin, and small molecule peptides (wheat / corn); Method: Quantitative detection by HPLC or LC-MS.

[0059] Stability Test (Accelerated Conditions): Conditions: 25°C, humidity 60%, storage for 30 days; Compare the content change rates of the main functional ingredients before and after storage (the experimental results are shown in Table 3).

[0060] Table 3 Comparison Data of Functional Ingredient Contents and Stabilities of Different Samples It can be seen from Table 3 that: As the main source of hypoglycemic activity, the content of ginsenosides in ginseng powder always remains above 10 mg / g in the examples, and the activity retention rate after 30 days of storage is also better than 90%. In Comparative Example 1, removing ginseng powder results in almost no ginsenosides in the test samples, and the retention rate also drops significantly, indicating that the presence of this ingredient in the formulation not only provides the core pharmacological function but also helps maintain the structural stability and activity synergy of the whole system. This phenomenon is consistent with the previous mechanism. Ginsenoside substances have a direct effect on glucose metabolism regulation and synergistically enhance the overall hypoglycemic and lipid-lowering effects with other plant extracts.

[0061] In addition, mulberry leaf powder, as a key raw material providing 1-deoxynojirimycin (1-DNJ), has a stable content of over 0.3% in the examples and is an important basis for inhibiting α-glucosidase and regulating blood sugar. After replacing it with aloe powder in Comparative Example 3, although there were no significant abnormalities in appearance and the tabletting process, 1-DNJ was completely absent in the functional component detection results, and the activity retention rate decreased most significantly within 30 days. This indicates that functional components cannot be arbitrarily replaced. Some plant components have specific target activities, and their pharmacological effects and structural stability cannot be replaced by non-target substances. This is highly consistent with the judgment pointed out in the previous mechanism analysis that "mulberry leaf powder is a function-positioned component and is indispensable".

[0062] In the examples, the ratio of wheat oligopeptide to corn oligopeptide is coordinated, with a molecular weight between 300–800 Da, and it has good solubility and stability. In Comparative Example 5, the content of corn oligopeptide exceeded the standard to 86.5 mg / g. Although the initial detection content was high, its structure aggregated and precipitated during storage, resulting in a significant decrease in activity. This result shows that the addition of polypeptide substances needs to balance the absorption efficiency and system stability. If it exceeds the dissolution limit, physical unstable behaviors such as protein aggregation and interfacial sedimentation will be triggered, thereby reducing the long-term stability and effectiveness of functional components.

[0063] Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A compressed candy with the function of reducing blood sugar and blood lipids, characterized in that: The compressed candy comprises the following components in parts by weight: Isomalt: 25-40 parts; Maltodextrin: 10-20 parts; Microcrystalline cellulose: 10-20 parts; Ginseng powder: 3-6 portions; Bitter melon powder: 3-5 portions; Mulberry leaf powder: 3-5 parts; Polygonatum sibiricum powder: 2-4 parts; Sea buckthorn powder: 2-4 parts; Wheat oligopeptides: 2-4 parts; Corn polypeptide: 2-4 parts; Collagen peptides: 2-4 servings; Albumin peptide: 2-4 parts; Snow lotus culture: 1-3 copies; Vitamin B1: 0.05-0.2 parts; Vitamin B2: 0.05-0.2 parts; Magnesium stearate: 0.8-1.6 parts; Erythritol: 10-20 parts.

2. The compressed candy with blood sugar and lipid lowering function according to claim 1, characterized in that: The total content of ginsenosides in the ginseng powder is ≥10%.

3. The compressed candy with blood sugar and lipid lowering function according to claim 1, characterized in that: The mulberry leaf powder contains ≥0.3% of 1-deoxynojirimycin and has a moisture content of ≤8%.

4. The compressed candy with blood sugar and lipid lowering function according to claim 1, characterized in that: The molecular weight of the wheat oligopeptide is 300-800Da, and the molecular weight of the corn oligopeptide is 200-600Da.

5. A method for preparing a compressed candy with the function of lowering blood sugar and blood lipids, characterized in that: The method for preparing the compressed candy with the function of lowering blood sugar and blood lipids according to any one of claims 1 to 4 comprises the following steps: S1. Raw material pretreatment: drying, sieving and uniformly mixing some raw materials; S2, dry granulation: the mixed raw materials are compressed into strips by roller dry granulation equipment and then crushed; S3, lubrication mixing: mixing the dry granules and lubricant magnesium stearate evenly; S4. Tablet forming and packaging: After the granules are tableted, they are packaged and stored in aluminum-plastic blisters or bottles.

6. The method for preparing the compressed candy with the function of lowering blood sugar and blood lipids according to claim 5, characterized in that: The raw material pretreatment step comprises: Dry ginseng powder, bitter melon powder, mulberry leaf powder, polygonatum powder, sea buckthorn powder, and snow lotus culture at 60°C for 4-6 hours to reduce the moisture content to ≤8%; Use 80-mesh and 100-mesh double-stage sieves to screen and remove coarse particles; The filtered materials, wheat oligopeptides, corn oligopeptides, collagen peptides, albumin peptides, microcrystalline cellulose, maltodextrin, isomalt, and erythritol are mixed according to the formula ratio, and stirred at 60-100 rpm in a horizontal mixer for 10-15 minutes.

7. The method for preparing the compressed candy with the function of lowering blood sugar and blood lipids according to claim 5, characterized in that: The dry granulation step comprises: The obtained mixture is fed into a roller-type dry granulator, the roller pressure is set to 5-8 MPa, the roller gap is controlled to 0.6-1.0 mm, and pressed into a strip or sheet compact; The compacted material is sent to a high-speed rotary knife crusher for crushing, the speed is set to 800-1200rpm, and the particle size of the fragments is controlled to be 0.2-1.0mm; The crushed material was sieved through a 0.8 mm sieve to obtain uniform particles.

8. The method for preparing the compressed candy with the function of lowering blood sugar and blood lipids according to claim 5, characterized in that: The lubrication mixing step comprises: Adding magnesium stearate to the granules obtained by dry granulation, wherein the amount of magnesium stearate added is 0.5-1.0% of the total formula mass; Mix in a horizontal mixer for 3-5 minutes at a speed of 50-80 rpm.

9. The method for preparing the compressed candy with the function of lowering blood sugar and blood lipids according to claim 5, characterized in that: The tableting and packaging comprises: The lubricated granules are fed into a rotary tablet press to be pressed into tablet candies. The diameter of the die is 8-10 mm, and the weight of the tablet candies is controlled to be 0.9-1.2 g / piece. The tableting pressure is set at 30-50 kN, the tablet hardness after compression is 60-100 N, and the friability is less than 1.0%; The finished tablets are packaged in aluminum-plastic blisters, with each plate containing 10 tablets and 0.5-1g of silica gel desiccant; After packaging, store in a dry environment with humidity ≤ 60% and temperature ≤ 25°C.

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