Composite combined preparation for synergistically treating and conditioning diabetes mellitus

Abstract

The invention discloses a composite combined preparation for synergistically treating and conditioning diabetes, relates to the technical field of foods, health foods or dietary supplements for adjuvant therapy and health care of diabetes, and in particular relates to a composite combined preparation for synergistically treating and conditioning diabetes. The preparation comprises albumin peptide, saussurea involucrata culture, vitamin B1, vitamin B2, wheat oligopeptide, corn oligopeptide, collagen peptide, mulberry leaf extract, rhizoma polygonati extract, sea-buckthorn extract, isomaltitol, maltodextrin, ginseng extract and bitter gourd extract. Through the synergistic effect of all the components, comprehensive auxiliary conditioning on diabetes is realized from multiple targets of maintaining colloid osmotic pressure and nutrition, regulating glycolipid metabolism in multiple ways, protecting pancreatic beta cell functions, enhancing insulin sensitivity, preventing nerve and blood vessel complications, meeting special diet requirements and the like. The composition can be prepared into food, health-care food or dietary supplement and other dosage forms.

Description

Technical Field

[0001] This invention relates to the field of food, health food or dietary supplement technology for the adjunctive treatment and health care of diabetes, specifically a compound preparation for the synergistic treatment and management of diabetes. Background Technology

[0002] Diabetes mellitus is a metabolic disease characterized by chronic hyperglycemia. Its core pathophysiological mechanisms include insufficient insulin secretion and / or insulin resistance. Poor long-term glycemic control can lead to a variety of serious complications, such as cardiovascular disease, neuropathy, retinopathy, nephropathy, and impaired wound healing, seriously endangering the patient's health.

[0003] Currently, diabetes management primarily relies on medication (such as insulin and oral hypoglycemic agents), dietary control, and exercise therapy. However, medication often has side effects and secondary failure, and single-target drugs are insufficient to comprehensively address the complex metabolic disorders and multi-system complications of diabetes. In terms of diet, diabetic patients often face challenges such as limited food choices and unpleasant tastes, especially difficulty satisfying their sweetness cravings. Traditional sweeteners may cause blood sugar fluctuations or pose health risks.

[0004] Many existing diabetes support products often have relatively simple ingredients or focus solely on directly lowering blood sugar, such as containing only a single plant extract or mineral. These products have a single functional target and cannot simultaneously address multiple key aspects such as maintaining overall nutritional status, protecting pancreatic islet cell function, improving insulin sensitivity, and preventing vascular and neurological complications, thus failing to achieve comprehensive diabetes management. For example, some products may neglect the supportive improvement of common diabetes patients' conditions such as hypoalbuminemia, microcirculatory disorders, and chronic inflammation. Furthermore, how to meet the specific taste and nutritional needs of diabetic patients without causing significant fluctuations in blood sugar remains a pressing challenge in current technology.

[0005] Therefore, there is an urgent need in this field to develop a compound composition that can integrate multiple active ingredients to achieve comprehensive auxiliary treatment of diabetes and its potential complications through multiple pathways and multiple targets, while also taking into account nutritional support and special dietary needs. Summary of the Invention

[0006] The purpose of this invention is to provide a compound preparation for the synergistic treatment and management of diabetes. This preparation scientifically combines multiple active ingredients to form a synergistic system. This composition is not simply a collection of ingredients, but rather achieves multi-target, comprehensive adjunctive management of diabetes by maintaining the body's osmotic pressure and basic nutrition, regulating glucose and lipid metabolism through multiple pathways, protecting and repairing pancreatic β-cell function, enhancing insulin sensitivity, preventing neurological and vascular complications, and meeting specific dietary needs.

[0007] To achieve the above objectives, this invention utilizes the following technical solutions: a compound preparation for the synergistic treatment and management of diabetes. Albumin peptides, as a key component, are crucial in diabetic patients who often experience protein metabolism disorders due to abnormal kidney function. Albumin peptides effectively maintain blood colloid osmotic pressure, preventing edema and malnutrition. Their small molecule characteristics facilitate rapid absorption, providing essential amino acids and enhancing overall nutritional status. Snow lotus culture regulates glucose and lipid metabolism through its natural active substances, reducing insulin resistance and possessing anti-inflammatory effects, alleviating common chronic inflammatory states in diabetes and improving tissue hypoxia. Vitamins B1 and B2, as coenzymes, participate in glucose metabolism. B1 is particularly helpful in neuroprotection, preventing diabetic neuropathy, while B2 promotes energy production and reduces oxidative stress. Wheat oligopeptides and corn oligopeptides synergistically enhance muscle glucose uptake and reduce blood sugar fluctuations; collagen peptides improve vascular health; mulberry leaf, polygonatum, and sea buckthorn extracts regulate blood sugar and lipids through multiple pathways; isomaltitol serves as a safe sweetener to meet dietary needs; and ginseng and bitter melon extracts directly affect insulin secretion and sensitivity. All these elements interact through multiple targets, such as nutritional support, metabolic regulation, and complication prevention, to achieve adjunctive management of diabetes rather than a single therapy, demonstrating the overall synergistic advantage.

[0008] Furthermore, human serum albumin or animal-derived albumin (such as bovine or porcine) can be processed using controlled enzymatic hydrolysis technology to obtain small-molecule albumin peptides with a concentrated molecular weight distribution and easy absorption. This is particularly important for diabetic patients, as some individuals in this group may experience weakened gastrointestinal motility and insufficient digestive enzyme secretion. Albumin peptides can be effectively absorbed through the peptide transport system of intestinal mucosal epithelial cells without further breakdown by pepsin or trypsin, greatly reducing the digestive burden, improving protein bioavailability, and ensuring the efficiency of nutritional supplementation. More importantly, diabetic nephropathy is a common microvascular complication. As the disease progresses, impaired renal filtration function can lead to significant albumin loss in urine, resulting in clinical "proteinuria" and hypoalbuminemia. Timely supplementation with easily absorbed albumin peptides helps correct the negative protein balance caused by renal abnormalities, maintains plasma albumin levels, thereby stabilizing colloid osmotic pressure, preventing or reducing edema, and providing the body with necessary amino acid resources. In addition, the liver, as the central organ of metabolism, is also susceptible to damage in diabetic states (such as fatty liver). Studies have shown that certain albumin peptide fragments may have specific protective effects on hepatocytes, potentially improving liver function through mechanisms such as anti-oxidative stress and inhibition of inflammatory responses. This is significant for maintaining systemic glucose and lipid metabolism homeostasis. Therefore, albumin peptides play a dual role in this composition, providing basic nutritional support and maintaining specific organ function.

[0009] Furthermore, unlike traditional methods relying on wild resources, snow lotus cultures obtained through in vitro cell culture technology can achieve standardized and large-scale production, ensuring stable content and batch-to-batch consistency of active ingredients (such as snow lotus flavonoids, snow lotus polysaccharides, and specific alkaloids). These active substances collectively constitute the basis for its regulation of glucose and lipid metabolism. In the intestinal tract, snow lotus flavonoids and other components have been shown to competitively inhibit the activity of carbohydrate-digesting enzymes such as α-glucosidase, thereby slowing down the rate at which complex carbohydrates in food are broken down into monosaccharides (such as glucose), effectively smoothing the postprandial blood glucose rise curve. At the tissue level, snow lotus polysaccharides and other components may promote the uptake and utilization of glucose from the blood by enhancing the activity or translocation of glucose transport proteins (such as GLUT4) on the cell membranes of insulin-sensitive tissues such as adipocytes and skeletal muscle cells, thereby reducing circulating blood glucose levels. Diabetes is considered a metabolic disease accompanied by chronic low-grade inflammation. Inflammatory factors such as TNF-α and IL-6 interfere with insulin signaling, leading to insulin resistance. The anti-inflammatory components in snow lotus cultures help improve this pathological inflammatory state. Meanwhile, pancreatic β-cells are prone to functional decline and even apoptosis under metabolic stress environments such as high glucose and high lipids. The anti-hypoxia and antioxidant properties exhibited by snow lotus culture may help protect pancreatic islet cells from damage and maintain their normal insulin secretion function. Therefore, snow lotus culture exerts an auxiliary regulatory effect through multiple pathways: "inhibiting the source (intestinal absorption)," "promoting the destination (tissue utilization)," and "improving the environment (anti-inflammatory and pancreatic islet protection)."

[0010] Furthermore, wheat oligopeptides are a mixture of small peptide molecules obtained by enzymatic hydrolysis of wheat protein. Specific peptide segments have been found to activate key proteins in the insulin signaling pathway within skeletal muscle cells, such as insulin receptor substrate (IRS) and phosphatidylinositol 3-kinase (PI3K), thereby promoting the translocation of glucose transporter 4 (GLUT4) to the cell membrane. This significantly enhances the uptake and oxidative utilization of glucose in skeletal muscle, the body's primary glucose processing organ, thus directly lowering blood glucose levels. In addition, some wheat peptides have the potential to protect pancreatic β-cells from glucose-lipid toxicity or oxidative stress damage, helping to maintain endogenous insulin secretion. Corn oligopeptides, derived from corn protein, are characterized by their high content of branched-chain amino acids (BCAAs) such as leucine, isoleucine, and valine. BCAAs and their metabolites can stimulate insulin secretion from pancreatic β-cells through various mechanisms, such as activating related pathways by generating signaling molecules. Simultaneously, corn oligopeptides can also inhibit hepatic gluconeogenesis. Gluconeogenesis, the process by which non-carbohydrate substances (such as lactate and glucogenic amino acids) are converted into glucose in the liver, is often abnormally active in diabetic patients and is one of the important causes of fasting hyperglycemia. Corn oligopeptides reduce the production of endogenous glucose by regulating the activity or expression of key gluconeogenic enzymes in hepatocytes. The two work synergistically: wheat oligopeptides mainly enhance glucose consumption in peripheral tissues (muscle), while corn oligopeptides focus on promoting insulin secretion and inhibiting hepatic glucose output, thus helping to alleviate the fatigue that may accompany diabetes from different perspectives, because improving glucose metabolism itself is beneficial for energy supply.

[0011] Furthermore, poorly controlled diabetes over a long period can lead to systemic vascular disease. Macrovascular disease manifests as accelerated atherosclerosis, while microvascular disease affects the retina, kidneys, nerves, and skin. Collagen is the main structural protein of blood vessel walls. Hyperglycemia causes non-enzymatic glycosylation of collagen, forming advanced glycation end products (AGEs), which increase cross-linking of collagen fibers in the blood vessel walls, decrease elasticity, and thicken and harden the vessel walls. Supplementing with collagen peptides of specific sequences (such as peptides rich in hydroxyproline) may provide repair materials for blood vessel walls, inhibit abnormal cross-linking, and help maintain the proper elasticity and compliance of blood vessels, thus assisting in the long-term prevention of arteriosclerosis and related cardiovascular and cerebrovascular complications. At the microcirculation level, diabetic foot ulcers and delayed wound healing are serious complications. This stems from microvascular disturbances, nerve ischemia, and impaired local tissue repair capacity caused by high glucose levels. Collagen is the main matrix for granulation tissue and scar formation. Exogenous supplementation with easily absorbed collagen peptides can provide sufficient substrates for repair cells such as fibroblasts, promote collagen synthesis, and accelerate the wound healing process. Meanwhile, collagen peptides are also crucial for maintaining skin hydration and elasticity, and may help improve common skin problems such as dryness and itching in diabetic patients. Therefore, collagen peptides in this composition are primarily positioned to support long-term vascular health maintenance and local tissue repair.

[0012] Furthermore, the core active substance in mulberry leaf extract is deoxynojirimycin (DNJ), which has a structure similar to glucose. It strongly and reversibly inhibits α-glucosidases (such as maltase and sucrase) on the brush border of the small intestine, preventing disaccharides and oligosaccharides from being broken down into monosaccharides for absorption, thus significantly reducing postprandial blood glucose peaks, similar to the mechanism of action of the drug acarbose. Studies also show that it has the potential to improve insulin resistance. Polygonatum extract is rich in Polygonatum polysaccharides and saponins, and its effects focus more on protecting and repairing pancreatic β-cell function. It may promote the recovery of damaged β-cells through antioxidant and anti-apoptotic mechanisms and participate in regulating glucose and lipid metabolism in the liver and peripheral tissues. Sea buckthorn extract is rich in flavonoids (such as isorhamnetin) and vitamins. Its mechanism of action involves activating nuclear transcription factors such as peroxisome proliferator-activated receptors (PPARs). Activation of PPARγ is an important pathway for improving insulin sensitivity (as a target of thiazolidinediones). Simultaneously, its strong antioxidant and anti-inflammatory capabilities help reduce oxidative stress damage to the pancreas and target tissues. These three extracts act on different stages of carbohydrate digestion (starch → oligosaccharides → monosaccharides), improve insulin sensitivity, protect pancreatic function, and regulate lipid metabolism, forming a synergistic network from "entry" control to "internal" regulation.

[0013] Furthermore, for diabetic patients, strictly limiting refined sugar intake is a fundamental requirement. However, the craving for sweetness is universal, and forcibly depriving them often impacts quality of life and adherence. Isomalt is a sugar alcohol sweetener with a pure sweetness, approximately 50%-60% that of sucrose. Its key characteristic lies in its unique metabolic pathway: it is absorbed very slowly in the small intestine, and after absorption, it is not largely utilized by insulin-dependent tissues. Most of it is transported to the liver for slow metabolism or excreted by the kidneys. This results in an extremely low glycemic index (GI value) (approximately 2), causing a very small and gradual rise in blood sugar and insulin levels, unlike sucrose which causes a sharp spike in blood sugar. Therefore, it can be safely used in foods for diabetic patients, satisfying their psychological and taste cravings for sweetness without interfering with blood sugar stability. Furthermore, isomaltitol has a low energy value (approximately 2 kcal / g), far lower than sucrose (4 kcal / g), which helps control total energy intake. This is especially important for diabetic patients who require weight management, as weight loss itself is one of the most effective ways to improve insulin resistance. Therefore, the addition of isomaltitol is a carefully designed feature that improves product palatability and supports long-term dietary management for patients, indirectly but significantly contributing to the overall management of diabetes.

[0014] Furthermore, ginseng, as a traditional and precious Chinese medicine, primarily contains ginsenosides (such as Rb1, Rg1, Re, etc.) and ginseng polysaccharides as its effective components for regulating blood sugar. Ginsenosides exert their effects through multiple pathways: firstly, they can directly or indirectly stimulate pancreatic β-cells, promoting insulin secretion; secondly, they can enhance the sensitivity of peripheral tissues such as skeletal muscle and fat to insulin, improving insulin resistance, for example, by upregulating the expression and translocation of GLUT4; thirdly, their antioxidant activity helps scavenge free radicals and protect pancreatic β-cells from oxidative damage. Ginseng polysaccharides may participate in glucose metabolism regulation through mechanisms such as immune regulation and protection of pancreatic islet cells. Bitter melon extract contains various active substances, such as bitter melon saponins, bitter melon polysaccharides, and especially bitter melon polypeptides (plant insulin), whose mode of action is similar to insulin. It can bind to insulin receptors or insulin-like receptors on the cell membrane, initiating downstream signaling pathways, promoting cellular glucose uptake and utilization, thereby lowering blood sugar. Simultaneously, bitter melon extract has also been reported to inhibit intestinal glucose absorption. Ginseng extract focuses on "opening up the source" (promoting secretion and enhancing sensitivity), while bitter melon extract focuses on "reducing the flow" (mimicking insulin to promote utilization and inhibit absorption). The two work synergistically from different angles and through different mechanisms to improve glucose metabolism disorders and may alleviate symptoms such as fatigue and thirst associated with diabetes.

[0015] Furthermore, setting the total weight percentage of both at 8%-15% is a result of comprehensive consideration of efficacy, safety, and formulation feasibility. Too low a percentage may fail to achieve effective blood drug concentrations or biological effect concentrations, making it difficult to demonstrate the expected synergistic effect in regulating glucose tolerance; too high a percentage may increase costs and introduce unnecessary formulation challenges (such as taste and physical properties), or even potential risks (such as individual tolerance to ginseng). Within this range, it ensures that the main active ingredients (ginsenosides and bitter melon polypeptides) reach the effective dose and produce a synergistic effect. The explicit stipulation that ginseng extract uses dried rhizomes as raw material and that the ginsenoside content is not less than 5% is to ensure the uniformity of extract quality and the stability of efficacy. Saponin content is a key indicator for evaluating the quality of ginseng extract; meeting this standard ensures the reliability of its effects in enhancing insulin sensitivity and antioxidation. Similarly, the stipulation that bitter melon extract (regardless of whether derived from fresh or dried materials) has a bitter melon polypeptide content of not less than 3% is to ensure the material basis for its insulin-like activity. Polypeptide content is a core indicator of the hypoglycemic efficacy of bitter melon. Such stringent quality control requirements are a prerequisite for achieving the synergistic effect described in claim 8, ensuring consistency between product batches and the reliability of the expected results.

[0016] Furthermore, the innovation of this composition lies in the fact that it is not a single component or a simple mixture, but rather an organic, multi-target synergistic system composed of all active ingredients. The effects of this system can be summarized at several levels: At the basic level, it maintains homeostasis (osmotic pressure) and tissue nutrition through albumin peptides and collagen peptides, providing a foundation for metabolic regulation; at the core regulatory level, it comprehensively regulates glucose and lipid metabolism through multiple pathways and targets, including inhibiting glucose absorption, promoting glucose utilization, regulating gluconeogenesis, improving insulin sensitivity, and protecting and repairing pancreatic function, using snow lotus culture, plant extracts (mulberry leaf, polygonatum, sea buckthorn, etc.), peptides (wheat, corn peptides), and ginseng and bitter melon; at the complication prevention level, it prevents neuropathy through vitamin B1, maintains vascular health through collagen peptides, and reduces tissue damage through antioxidant and anti-inflammatory components; at the lifestyle support level, it meets special dietary needs through isomaltitol. This multi-level, multi-mechanism synergy aims to achieve a more comprehensive and gentler integrated auxiliary management of diabetes. Finally, it is clearly stated that the composition can be prepared into dosage forms such as ordinary food, health food or dietary supplement (e.g., powder, capsule, tablet, beverage, etc.), providing a clear direction for its industrial application and enabling it to serve people with relevant needs in a convenient and acceptable form.

[0017] This invention provides a compound preparation for the synergistic treatment and management of diabetes, which has the following beneficial effects:

[0018] 1. This compound formulation, through the synergistic effects of multiple natural ingredients, assists in regulating glucose and lipid metabolism in diabetic patients via multiple biological pathways. For example, the flavonoids and polysaccharides in snow lotus culture can inhibit excessive absorption of sugar in the intestines while promoting glucose uptake by adipocytes, thereby reducing the accumulation of sugar in the blood; mulberry leaf extract effectively reduces postprandial blood glucose peaks by inhibiting α-glucosidase activity, preventing drastic blood glucose fluctuations; polygonatum extract participates in repairing pancreatic β-cells and enhances their insulin secretion function; while sea buckthorn extract improves insulin resistance by activating related receptors and exerts anti-inflammatory effects. These effects are synergistic, not only targeting the direct causes of elevated blood glucose but also taking into account the balance of lipid metabolism, such as reducing triglyceride accumulation. This multi-target regulatory approach avoids the limitations of single-component effects, making blood glucose levels more stable, especially suitable for long-term diabetic patients requiring comprehensive management, thereby reducing the risks of blood glucose fluctuations and improving overall metabolic health.

[0019] 2. The ginseng extract and bitter melon extract in this preparation work synergistically to directly target the core pathological aspects of diabetes—pancreatic islet cell damage and insulin resistance. Ginseng extract, rich in ginsenosides and polysaccharides, stimulates insulin secretion and enhances the sensitivity of peripheral tissues to insulin, making glucose more readily available for cellular utilization. Bitter melon extract mimics the function of insulin, promoting glucose entry into cells for energy conversion and inhibiting gluconeogenesis. Furthermore, snow lotus culture can protect pancreatic islet cells from damage and maintain their normal function under hypoxic conditions. This synergistic protective mechanism not only helps restore some pancreatic islet function but also reduces cell apoptosis caused by high glucose toxicity, thereby slowing the progression of diabetes. For early-stage diabetes patients, this may mean better potential for glycemic control; for late-stage patients, it can reduce insulin dependence, improve overall quality of life, and lower the probability of complications.

[0020] 3. This combination formulation effectively prevents common diabetic complications through the synergistic effects of components such as albumin peptides, collagen peptides, and vitamin B1. Albumin peptides can improve hypoalbuminemia caused by abnormal kidney function, increase colloid osmotic pressure, and reduce edema and kidney burden. Collagen peptides, through a specific tripeptide sequence, enhance vascular elasticity, prevent arteriosclerosis and related cardiovascular problems, and promote wound healing under microcirculatory disturbances, which is particularly beneficial for skin problems such as diabetic foot. Vitamin B1 participates in glucose metabolism, directly protects nerve tissue, and reduces the risk of peripheral neuropathy. These components work together to build a protective network at the vascular, nerve, and organ levels, addressing not only blood sugar control but also secondary issues in long-term diabetes management, such as the risk of nephropathy, retinopathy, or infection. This comprehensive protection helps patients maintain better physical condition, reduce hospitalization needs, and improve daily activity levels.

[0021] 4. This formulation takes into account the common nutritional absorption disorders and dietary restrictions faced by diabetic patients, providing adaptive support through ingredients such as albumin peptides and isomaltitol. Albumin peptides, as small molecule peptides, can be directly absorbed without digestion, making them particularly suitable for diabetic patients with weakened gastrointestinal function. They can effectively improve low protein levels and liver function, enhancing overall nutritional status. Isomaltitol, as a low-calorie sweetener, satisfies patients' psychological need for sweetness without causing significant fluctuations in blood sugar, helping them adhere to dietary control. Simultaneously, other carriers, such as maltodextrin, ensure the formulation is easy to take. This design allows patients to obtain necessary nutrients without increasing their metabolic burden, avoiding the problems of malnutrition or poor adherence that often occur in traditional dietary management. It is especially suitable for elderly or frail patients, thereby indirectly improving insulin resistance and optimizing long-term prognosis through weight management.

[0022] 5. This formulation, through the synergistic effect of wheat oligopeptides, corn oligopeptides, and vitamin B2, addresses common issues in diabetic patients such as fatigue and insufficient energy. Wheat oligopeptides enhance the activity of glucose transporters in skeletal muscle cells, accelerating glucose uptake and utilization for rapid energy provision; corn oligopeptides stimulate insulin release through branched-chain amino acids and inhibit hepatic gluconeogenesis, maintaining stable energy supply. Vitamin B2 participates in mitochondrial energy metabolism, reducing fatigue caused by oxidative stress. These components work together to optimize glucose energy conversion efficiency and reduce fatigue caused by glucose metabolism disorders, making patients more energetic in daily activities. This effect is particularly important for improving exercise tolerance and mental state in diabetic patients, helping to establish a positive lifestyle and creating a virtuous cycle that supports overall treatment effectiveness. Attached Figure Description

[0023] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0024] Figure 1 This is a flowchart illustrating the overall synergistic effect of the composite composition of the present invention.

[0025] Figure 2 This is a flowchart illustrating the action of albumin peptide, snow lotus culture, vitamin B1, and vitamin B2 in this invention.

[0026] Figure 3 This is a flowchart illustrating the synergistic effect of wheat oligopeptides, corn oligopeptides, and collagen peptides in this invention.

[0027] Figure 4This is a flowchart illustrating the synergistic regulation of mulberry leaf, polygonatum, and sea buckthorn extracts according to the present invention.

[0028] Figure 5 This is a flowchart illustrating the synergistic effect of ginseng and bitter melon extracts in this invention. Detailed Implementation

[0029] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numerals in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this disclosure. Rather, they are merely examples of apparatuses consistent with some aspects of this disclosure as detailed in the appended claims.

[0030] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0031] Example 1

[0032] A compound preparation for the synergistic treatment and management of diabetes, comprising the following components and weight percentages: 15% albumin peptide (derived from bovine blood hydrolysis), 8% snow lotus culture (snow lotus flavonoid content not less than 2%), 0.5% vitamin B1, 0.5% vitamin B2, 10% wheat oligopeptides (molecular weight less than 1000 Daltons), 10% corn oligopeptides (branched chain amino acid content not less than 20%), 5% collagen peptides (derived from deep-sea fish skin, containing a specific -gly-pro-hyp sequence), 8% mulberry leaf extract (α-glucosidase inhibition rate higher than 50%), 7% polygonatum extract (polysaccharide content not less than 30%), 5% sea buckthorn extract (total flavonoid content not less than 3%), 15% isomaltitol, 10% maltodextrin, 3% ginseng extract (ginsenoside content not less than 5%), and 3% bitter melon extract (bitter melon polypeptide content not less than 3%).

[0033] The preparation process in this embodiment is as follows: First, maltodextrin and isomaltitol are dry-mixed as a carrier matrix to ensure uniformity. Then, in ascending order of weight percentage, trace components such as vitamin B1, vitamin B2, ginseng extract, and bitter melon extract are sequentially diluted with a portion of the carrier matrix in equal increments and thoroughly mixed. Next, major active ingredients such as albumin peptides, snow lotus culture, wheat oligopeptides, corn oligopeptides, collagen peptides, mulberry leaf extract, polygonatum extract, and sea buckthorn extract are gradually added. Each addition of an ingredient requires thorough stirring to ensure no lumps and uniform mixing. Finally, the mixture is sieved through an 80-mesh sieve to ensure consistent powder fineness, and then sealed in airtight packaging to prevent moisture absorption.

[0034] This composition is prepared as a convenient powder for easy preparation. The method of use is as follows: twice daily, dissolve 10 grams of the product in approximately 200 ml of warm water, stir well, and drink. It is recommended to take it half an hour before lunch and dinner. This usage aims to utilize mulberry leaf extract to inhibit intestinal α-glucosidase activity in advance, thereby slowing down the absorption rate of carbohydrates after meals. Simultaneously, the albumin peptides, wheat oligopeptides, and corn oligopeptides supplemented before meals are rapidly absorbed, providing the body with readily available nitrogen and energy, and initiating regulatory mechanisms for glucose metabolism in advance, such as enhancing the glucose uptake potential of skeletal muscle. Long-term consistent use helps users stabilize postprandial blood sugar levels, and through the synergistic effects of various components, such as snow lotus culture regulating glucose and lipid metabolism, collagen peptides maintaining vascular elasticity, and ginseng and bitter melon extracts improving insulin sensitivity, it achieves comprehensive multi-target adjuvant conditioning for diabetes.

[0035] Example 2

[0036] A compound preparation for the synergistic treatment and management of diabetes comprises the following components and weight percentages: albumin peptides (derived from hydrolyzed pig blood) 12%, snow lotus culture (snow lotus polysaccharide content not less than 10%) 10%, vitamin B1 0.8%, vitamin B2 0.8%, wheat oligopeptides 12%, corn oligopeptides 12%, collagen peptides (derived from bovine Achilles tendon) 8%, mulberry leaf extract 10%, polygonatum extract 6%, sea buckthorn extract 6%, isomaltitol 10%, maltodextrin 8%, ginseng extract (ginsenoside content not less than 8%) 2.2%, and bitter melon extract (bitter melon polypeptide content not less than 5%) 2.2%. The total weight percentage of ginseng and bitter melon extracts is 4.4%.

[0037] This embodiment focuses on the preparation process of capsule dosage forms. All solid raw materials are pre-pulverized to a fineness of 100 mesh or higher. Then, all ingredients except vitamin B1 and vitamin B2 are added to a three-dimensional motion mixer and mixed for at least 45 minutes to ensure thorough homogenization. The mixed powder is then filled into capsules under low temperature and low humidity conditions (temperature below 25°C, relative humidity below 45%) using No. 0 plant-based capsule shells. After filling, the capsules are polished to remove surface dust and then packaged in aluminum-plastic blister packs to further enhance the product's moisture resistance and stability.

[0038] This composition is administered orally in capsule form. The recommended dosage is 3 capsules three times daily, taken with warm water after breakfast, lunch, and dinner. Taking it after meals reduces potential gastrointestinal irritation and may mix with food, mimicking the slow release and absorption of natural components in food. This regimen is particularly suitable for users with relatively weak gastrointestinal function or those who wish to simplify their supplementation process. The formulation appropriately increases the proportions of snow lotus culture, polygonatum, and sea buckthorn extracts to enhance their synergistic effects in regulating glucose and lipid metabolism and anti-inflammatory and antioxidant properties. The synergistic effect of corn oligopeptides and wheat oligopeptides helps promote insulin secretion and accelerate glucose utilization in peripheral tissues after meals, thereby assisting in controlling postprandial blood glucose spikes. Long-term use aims to help improve overall glucose metabolism through synergistic effects across multiple pathways.

[0039] Example 3

[0040] A compound preparation for the synergistic treatment and management of diabetes comprises the following components and weight percentages: albumin peptides 18%, snow lotus culture 6%, vitamin B1 0.3%, vitamin B2 0.3%, wheat oligopeptides 8%, corn oligopeptides 8%, collagen peptides (aimed at strengthening vascular protection and tissue repair functions) 12%, mulberry leaf extract 5%, polygonatum extract 8%, sea buckthorn extract 4%, isomaltitol 12%, maltodextrin 15%, ginseng extract 1.5%, and bitter melon extract 1.9%. The total weight of ginseng and bitter melon extracts is 3.4%.

[0041] The preparation process in this embodiment is optimized for tablet formability. After uniformly mixing the powdered components, an appropriate amount of purified water is added as a wetting agent to form a soft mass, which is then granulated through a 20-mesh sieve. The obtained wet granules are dried at a low temperature below 60°C until the moisture content is below 5%, and then granulated using a granulator. Subsequently, magnesium stearate is added as a lubricant, and the mixture is fed into a tablet press to compress tablets weighing approximately 1.0 gram each. A thin film coating can be applied to the tablet surface to mask some of the raw material odor and improve oral smoothness.

[0042] This composition is formulated into tablets for easy portability and dosage. The recommended dosage is two tablets twice daily, morning and evening, preferably taken with breakfast and dinner or immediately after meals. This formula significantly increases the proportion of collagen peptides, aiming to specifically support the prevention of common vascular complications and improve microcirculation in diabetic patients. Specific collagen peptide sequences help maintain the elasticity of blood vessel walls, potentially contributing to slowing the progression of arteriosclerosis and providing a material basis for their participation in skin and tissue repair and promoting potential wound healing. This formula is designed to enhance the adjunctive prevention of long-term complications beyond basal blood glucose regulation, making it particularly suitable for middle-aged and elderly diabetic patients with a longer disease duration or those showing signs of mild vascular neuropathy. Combined with albumin peptides to improve nutritional status and the anti-inflammatory functions of snow lotus culture, it forms a comprehensive adjunctive treatment plan that focuses more on tissue protection.

[0043] Example 4

[0044] A compound preparation for the synergistic treatment and management of diabetes comprises the following components and weight percentages: albumin peptides 10%, snow lotus culture 12%, vitamin B1 1.0%, vitamin B2 1.0%, wheat oligopeptides 15%, corn oligopeptides 15%, collagen peptides 3%, mulberry leaf extract 12%, polygonatum extract 5%, sea buckthorn extract 5%, isomaltitol 5%, maltodextrin 5%, ginseng extract 4%, and bitter melon extract 7%. The total weight percentage of ginseng and bitter melon extracts is 11%.

[0045] The preparation process in this embodiment is similar to that in Example 1, producing a powder, but the mixing order is further optimized: vitamins B1 and B2 are first fully premixed with a small amount of maltodextrin, then mixed with plant extracts such as snow lotus culture and mulberry leaf extract, and finally various peptides are added to reduce possible reactions when vitamins come into direct contact with certain components. The product is packaged into 5-gram packets, one packet per dose, ensuring high precision and good moisture resistance.

[0046] The recommended usage for this combination is as follows: twice daily, one sachet (5 grams) each time, dissolved in 150 ml of warm water, milk, or soy milk, as a meal replacement or snack. It is suggested to supplement around 10 AM or 4 PM when blood sugar levels are more likely to fluctuate. This formula features a significantly increased proportion of wheat and corn oligopeptides, designed to leverage their rapid absorption, glucose utilization promotion, and fatigue relief properties to provide energy support between meals, avoiding excessive subsequent blood sugar spikes caused by hypoglycemia or hunger. Simultaneously, the higher proportion of snow lotus culture and mulberry leaf extract continues to regulate glucose and lipid absorption and metabolism during this snack period. The synergistic effect of ginseng and bitter melon extracts is also enhanced in this formula, aiming to more significantly improve insulin sensitivity and promote glucose utilization. This regimen is suitable for individuals with fast-paced lifestyles who require snack supplementation or wish to enhance pre- and post-exercise blood sugar management.

[0047] Example 5

[0048] A compound preparation for the synergistic treatment and management of diabetes comprises the following components and weight percentages: albumin peptides 20%, snow lotus culture 5%, vitamin B1 0.6%, vitamin B2 0.6%, wheat oligopeptides 9%, corn oligopeptides 9%, collagen peptides 10%, mulberry leaf extract 6%, polygonatum extract 9%, sea buckthorn extract 7%, isomaltitol 8%, maltodextrin 5%, ginseng extract 3.5%, and bitter melon extract 3.3%. The total weight of ginseng and bitter melon is 6.8%.

[0049] The preparation process in this embodiment involves directly irradiating and sterilizing the uniformly mixed powder, followed by nitrogen-filled packaging. The product is in the form of canned powder, with a net content of 200 grams per can, and includes a measuring spoon (one level spoonful is approximately 5 grams). This process simplifies the procedure and preserves the natural activity of each component to the greatest extent.

[0050] The usage of this composition is relatively flexible and can be adjusted according to individual needs and dietary habits. The basic dosage is one level scoop (approximately 5 grams) twice daily, which can be added to warm water, porridge, soup, or yogurt. For individuals with poor nutritional status requiring enhanced nutritional support, the dosage can be increased to three times daily, or appropriately increased to 7-8 grams per dose. This formula balances the nutritional support function of albumin peptides, the glucose and lipid metabolism regulation function of various plant extracts, and the vascular protection function of collagen peptides, aiming to provide a relatively balanced foundation for adjunctive therapy. The high proportion of albumin peptides is designed to prioritize improving the risk of hypoalbuminemia and overall nutritional status in diabetic patients, laying the foundation for the other components to function. The addition of isomaltitol gives the product a mild sweetness, improving palatability for long-term use. This flexible usage plan is suitable for a wide range of diabetic patients with adjunctive therapy needs; the dosage can be adjusted within the recommended range according to individual circumstances to achieve personalized comprehensive adjunctive management goals.

[0051] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A compound preparation for the synergistic treatment and management of diabetes, comprising albumin peptides, snow lotus culture, vitamin B1, vitamin B2, wheat oligopeptides, corn oligopeptides, collagen peptides, mulberry leaf extract, polygonatum extract, sea buckthorn extract, isomaltitol, maltodextrin, ginseng extract, and bitter melon extract, characterized in that: The albumin peptide is used to maintain colloidal osmotic pressure and enhance nutrient absorption; the snow lotus culture is used to regulate glucose and lipid metabolism and to resist inflammation and hypoxia; the vitamin B1 is used to participate in glucose metabolism and prevent neuropathy; and the vitamin B2 is used to participate in energy metabolism and provide antioxidant protection. Through the synergistic effect of these components, multi-target adjuvant diabetes management is achieved.

2. The compound preparation for synergistic treatment and management of diabetes according to claim 1, characterized in that: The albumin peptides are small molecule peptides obtained by hydrolyzing human serum albumin or animal albumin. Their function is to improve hypoalbuminemia caused by abnormal renal function in diabetic patients. Due to their small molecule characteristics, they can be directly absorbed without digestion, making them suitable for patients with impaired gastrointestinal function. They also have the effect of protecting hepatocytes and improving liver function.

3. The compound preparation for synergistic treatment and management of diabetes according to claim 1, characterized in that: The snow lotus culture is a metabolite of snow lotus cells in vitro, containing snow lotus flavonoids, polysaccharides and alkaloids. Its function is to inhibit intestinal sugar absorption and promote glucose uptake by adipocytes. At the same time, it exerts an auxiliary effect on diabetes by improving chronic inflammation and protecting pancreatic islet cell function under hypoxic conditions.

4. A compound preparation for the synergistic treatment and management of diabetes according to claim 1, characterized in that: The wheat oligopeptides and corn oligopeptides work synergistically; the wheat oligopeptides accelerate glucose uptake and protect pancreatic islet cells by enhancing the activity of glucose transporters in skeletal muscle cells, while the corn oligopeptides stimulate insulin secretion and inhibit gluconeogenesis through their rich branched-chain amino acids, together helping to lower blood sugar and relieve fatigue.

5. A compound preparation for the synergistic treatment and management of diabetes according to claim 1, characterized in that: The collagen peptides are specific tripeptide sequences obtained by hydrolyzing animal-derived collagen. Their function is to improve the elasticity of blood vessels in diabetic patients to prevent arteriosclerosis complications, participate in tissue repair to promote wound healing that is prone to occur due to microcirculation disorders, and also benefit the improvement of skin symptoms.

6. A compound preparation for the synergistic treatment and management of diabetes according to claim 1, characterized in that: The mulberry leaf extract, polygonatum extract, and sea buckthorn extract work synergistically. Mulberry leaf extract reduces postprandial blood glucose and improves insulin resistance by inhibiting α-glucosidase, polygonatum extract promotes pancreatic β-cell repair and regulates glucose and lipid metabolism, and sea buckthorn extract improves insulin resistance and has antioxidant and anti-inflammatory effects by activating receptors, thus jointly regulating glucose and lipid levels.

7. A compound preparation for the synergistic treatment and management of diabetes according to claim 1, characterized in that: Isomalt, as a low-calorie sweetener, is metabolized without insulin and has a low glycemic index. It is used to meet the sweetness needs of diabetic patients without causing significant fluctuations in blood sugar. Due to its low calorie content, it also helps with weight management and indirectly improves the risk of insulin resistance.

8. A compound preparation for the synergistic treatment and management of diabetes according to claim 1, characterized in that: The ginseng extract and bitter melon extract work synergistically; the ginseng extract promotes insulin secretion, enhances insulin sensitivity, and provides antioxidant protection for pancreatic islet cells through its saponins and polysaccharides, while the bitter melon extract exerts an insulin-like effect to promote glucose utilization and inhibit glucose absorption. Together, they improve glucose metabolism and alleviate related symptoms.

9. A compound preparation for synergistic treatment and management of diabetes according to claims 1 to 8, characterized in that: The total weight percentage of ginseng and bitter melon is 8%-15%, wherein ginseng enhances insulin sensitivity through ginsenosides, and bitter melon mimics the action of insulin through bitter melon polypeptides. The two work synergistically to improve glucose tolerance and antioxidant capacity. The ginseng is a dried rhizome extract with a saponin content of not less than 5%, and the bitter melon is a fresh or dried extract with a polypeptide content of not less than 3%.

10. A compound preparation for synergistic treatment and management of diabetes according to claims 1-9, characterized in that: All the active ingredients in the composition together form a synergistic system, which can achieve comprehensive auxiliary treatment of diabetes by maintaining osmotic pressure and nutrition, regulating multiple pathways of glucose and lipid metabolism, protecting pancreatic β-cell function, improving insulin sensitivity, preventing neurological and vascular complications, and meeting special dietary needs. The composition can be prepared into dosage forms such as food, health food, or dietary supplement.

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