A composition of red-topped bamboo fungus polysaccharide for targeted blood sugar regulation, its preparation method and application

Abstract

This invention provides a composition for targeted blood sugar regulation aided by *Dictyophora indica* polysaccharide, its preparation method, and its application, belonging to the technical field of edible fungus extracted polysaccharide health food. The composition of this invention comprises 4-6 parts of *Dictyophora indica* polysaccharide, 1-2 parts of *Sandoan*, 1-3 parts of theaflavins, 18-22 parts of 7-day intestinal health supplement, and 5-7 parts of freeze-dried *Tremella fuciformis* powder. The composition of this invention has a significant blood sugar lowering effect in prediabetes, and the raw materials are readily available, allowing for long-term use without toxic side effects.

Description

Technical Field

[0001] This invention belongs to the field of edible fungi extracted polysaccharide health food technology, and particularly relates to a composition of red-topped bamboo fungus polysaccharide for targeted blood sugar regulation, its preparation method and application. Background Technology

[0002] Diabetes is one of the most serious chronic diseases threatening human health. Currently, there are many blood sugar-lowering products on the market, and the research and development of diabetes drugs mainly focuses on long-acting GLP-1RAs (glucagon-like peptide-1 receptor agonists), including dulaglutide, smegglutide, and polyethylene glycol loxenatide. In addition, there are insulin + GLP-1RA, biosimilars, and oral combination preparations. Currently, there is a lack of products specifically targeting prediabetes. People with prediabetes may not have symptoms initially, but if left untreated, it is likely to develop into diabetes. According to the WHO 1999 criteria, prediabetes is defined as a fasting blood glucose (FBG) level of 6.1 mmol / L ≤ FBG < 7.0 mmol / L.

[0003] Red-topped bamboo fungus is sold commercially as bamboo fungus eggs and fruiting bodies, mainly in fresh and dried forms. The volva (the base of the fungus) constitutes the largest portion of the fruiting body, accounting for approximately 37% to 50% of the total fresh weight. The fruiting bodies are discarded after harvesting, resulting in resource waste and environmental pollution. Although Huang Qingbin et al. (2019) extracted bamboo fungus polysaccharides from bamboo fungus and produced polysaccharide lozenges, and Infinitus (China) Co., Ltd.'s Infinitus brand Poria cocos, bamboo fungus, shiitake mushroom, astragalus, and tremella tablets obtained a health food approval in 2019 (National Food and Drug Administration Registration No. G20100639), bamboo fungus is a major ingredient, functional formulations that target the active ingredients of red-topped bamboo fungus polysaccharides to regulate blood sugar at the cellular level for different prediabetic populations still need further development. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a composition of red-topped bamboo fungus polysaccharide for targeted blood sugar regulation, which has a significant blood sugar lowering effect in prediabetes, and the raw materials of the composition are easy to obtain and can be taken for a long time.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0006] This invention provides a composition for targeted blood sugar regulation assisted by red-topped bamboo fungus polysaccharide. By mass, the composition includes: 4-6 parts of red-topped bamboo fungus polysaccharide, 1-2 parts of sandoan, 1-3 parts of theaflavins, 18-22 parts of 7-day intestinal health supplement, and 5-7 parts of lycopene powder of tremella.

[0007] Preferably, the composition comprises, by weight parts: 5 parts of red-topped bamboo fungus polysaccharide, 1.5 parts of sandoan, 2 parts of theaflavins, 20 parts of 7-day sausage, and 6 parts of tremella freeze-dried powder.

[0008] Preferably, the polysaccharide from *Dictyophora indica* is derived from the volva of *Dictyophora indica*.

[0009] Preferably, the Smith degradation product of the red-topped bamboo fungus polysaccharide contains glycerol, erythritol, arabinose, mannose, and glucose.

[0010] Preferably, the polysaccharide from *Dictyophora indica* contains 1-3 glycosidic bonds, 1-2,3 glycosidic bonds, 1-3,4 glycosidic bonds, 1-3,6 glycosidic bonds, and / or 1-2,3,4 glycosidic bonds.

[0011] The present invention also provides a method for preparing the above composition, comprising the following steps: mixing each raw material sequentially according to the stated proportion to obtain a mixture.

[0012] The present invention also provides the application of the above composition in the preparation of hypoglycemic products.

[0013] Preferably, the product includes food, health products, or medicines.

[0014] The beneficial effects of this invention are:

[0015] The composition of this invention has a significant hypoglycemic effect in prediabetes. In prediabetic patients who underwent one month of intervention, fasting blood glucose levels were improved, with an effectiveness rate of 100%. The average fasting blood glucose level decreased from 6.48 mmol / L to 5.28 mmol / L, a reduction of 18.52%. Attached Figure Description

[0016] Figure 1 : Results of the experiment of red-topped bamboo fungus polysaccharide-Congo red;

[0017] Figure 2 Scanning electron microscope image of polysaccharide from *Dictyophora indicum*. Detailed Implementation

[0018] This invention provides a composition for targeted blood sugar regulation assisted by *Dictyophora indicum* polysaccharide. By weight, the composition comprises: 4-6 parts of *Dictyophora indicum* polysaccharide, 1-2 parts of sangduoan, 1-3 parts of theaflavins, 18-22 parts of 7-day intestinal supplement, and 5-7 parts of freeze-dried tremella powder. Preferably, the composition comprises: 5 parts of *Dictyophora indicum* polysaccharide, 1.5 parts of sangduoan, 2 parts of theaflavins, 20 parts of 7-day intestinal supplement, and 6 parts of freeze-dried tremella powder.

[0019] This invention uses a "structure-activity, component-activity, and dose-effect" approach to target the active ingredients of edible and medicinal fungi at the cellular level to address the prediabetic symptoms of different individuals. Through personalized formulation and precise conditioning research, the resulting composition exhibits significant blood sugar lowering effects in prediabetes. Furthermore, the raw materials for this formulation are readily available and can be taken long-term.

[0020] The polysaccharide from *Dictyophora indica* described in this invention is derived from the volva of *Dictyophora indica*. This invention solves the environmental pollution problem caused by discarding the volva in the development of the edible fungus industry by selecting polysaccharides extracted from the volva, and extends the industrial chain. The polysaccharide from *Dictyophora indica* described in this invention can be purchased or obtained using conventional extraction methods.

[0021] The Smith degradation product of *Dictyophora indicum* polysaccharide described in this invention contains glycerol, erythritol, arabinose, mannose, and glucose; the *Dictyophora indicum* polysaccharide contains 1-3 glycosidic bonds, 1-2,3 glycosidic bonds, 1-3,4 glycosidic bonds, 1-3,6 glycosidic bonds, and / or 1-2,3,4 glycosidic bonds. The *Dictyophora indicum* polysaccharide described in this invention can effectively enhance the hypoglycemic efficacy of the composition, synergistically enhance the effects with other raw material components, and in clinical practice, its targeted blood glucose regulation effect is significantly more significant than that of single-component hypoglycemic applications.

[0022] The components of this invention, including sangdoan, theabrownin, 7-day sausage, and tremella freeze-dried powder, are readily available through conventional purchasing. All of these components meet food safety requirements. The components described in this invention are widely available and easily obtained, effectively driving the development of related products.

[0023] The present invention also provides a method for preparing the above composition, comprising the following steps: mixing each raw material sequentially according to the stated proportion to obtain a mixture.

[0024] The composition of the present invention can be taken directly, and the method of administration can be to take 30-40g each time in the morning and evening for 30 days; the composition of the present invention can also be taken for a long period of time.

[0025] The present invention also provides the application of the above composition in the preparation of hypoglycemic products, including food, health products or pharmaceuticals.

[0026] The technical solutions of this invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0027] Unless otherwise specified, the following embodiments are all conventional methods.

[0028] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0029] In the specific embodiments described in this invention, the polysaccharides of red-topped bamboo fungus, sangduoan, theabrownin, 7-day intestinal health supplement, and freeze-dried tremella powder were purchased from the market.

[0030] Example 1

[0031] A composition for targeted blood sugar regulation assisted by red-topped bamboo fungus polysaccharide, comprising: 4g red-topped bamboo fungus polysaccharide, 1g sangduoan, 1g theaflavins, 18g 7-day intestinal health supplement, and 5g lyophilized tremella powder. The raw materials are mixed sequentially according to the stated proportions in a clean, negative-pressure environment at room temperature to obtain the composition.

[0032] Example 2

[0033] A composition for targeted blood sugar regulation assisted by red-topped bamboo fungus polysaccharide, comprising: 6g red-topped bamboo fungus polysaccharide, 2g sangduoan, 3g theaflavins, 22g 7-day intestinal health supplement, and 7g lyophilized tremella powder. The raw materials are mixed sequentially according to the stated proportions in a clean, negative-pressure environment at room temperature to obtain the composition.

[0034] Example 3

[0035] A composition for targeted blood sugar regulation assisted by red-topped bamboo fungus polysaccharide, comprising: 5g red-topped bamboo fungus polysaccharide, 1.5g sangduoan, 2g theaflavins, 20g 7-day intestinal health supplement, and 6g lyophilized tremella powder. The raw materials are mixed sequentially according to the stated proportions in a clean, negative-pressure environment at room temperature to obtain the composition.

[0036] Comparative Example 1

[0037] A composition for targeted blood sugar regulation assisted by red-topped bamboo fungus polysaccharide, comprising: 1.5g of Sandoan and 20g of 7-Day Intestinal Health Supplement. The raw materials are mixed sequentially according to the stated proportions in a clean, negative-pressure environment at room temperature to obtain the composition.

[0038] Comparative Example 2

[0039] A composition for targeted blood sugar regulation assisted by red-topped bamboo fungus polysaccharide, comprising: 1.5g of Sandoan, 20g of 7-day Intestinal Health Supplement, and 6g of lyophilized tremella powder. The raw materials are mixed sequentially according to the stated proportions in a clean, negative-pressure environment at room temperature to obtain the composition.

[0040] Example 4

[0041] This embodiment detects the polysaccharides from *Dictyophora indicum* in Examples 1-3:

[0042] 1. The molecular weight of polysaccharides from *Dictyophora indicum* was determined by high-performance gel permeation chromatography. All experimental results were obtained by Jiangnan University, and the results are shown in Tables 1 and 2.

[0043] Table 1. Molecular weight distribution of polysaccharides from *Dictyophora indicum* determined by HPGPC.

[0044]

[0045] Table 2. Molecular weight of tocopherol polysaccharide from *Dictyophora indicum* determined by HPGPC-MALLS.

[0046]

[0047] As shown in Tables 1 and 2, the relative molecular weight of the polysaccharide from *Dictyophora indicum* is 3.8948 × 10⁻⁶. 4 Da; absolute molecular weight is 1.974 × 10⁻⁶ 5 g / mol, containing 1-3, 1-4, and 1-6 glycosidic bonds; possessing a three-dimensional helical structure; the molecular weight distribution of *Dictyophora indica* polysaccharide has two elution peaks, with a large peak at a retention time of 13.719 min, and its weight-average molecular weight (Mw) is 3.005 × 10⁻⁶ g / mol. 6 Da accounted for 97.33% of the molecular weight distribution of the polysaccharide samples.

[0048] 2. The structure of polysaccharides from *Dictyophora indicum* was analyzed using the Congo red assay. All experimental results were obtained by Jiangnan University and are shown below. Figure 1 :

[0049] Depend on Figure 1 It is known that the polysaccharide of *Dictyophora indicum* can form a complex with Congo red, resulting in a redshift, and is a polysaccharide with a three-dimensional helical structure.

[0050] 3. The polysaccharides in *Dictyophora indicum* were detected using scanning electron microscopy. All experimental results were obtained by Jiangnan University, and the results are shown below. Figure 2 :

[0051] Depend on Figure 2 It is evident that the polysaccharide from *Dictyophora indicum* exhibits a three-dimensional, slightly smooth, dense, lamellar porous structure, with some spherical and rod-shaped structures attached to its surface, and the edges of the pores displaying a fibrous structure. This indicates that the polysaccharide from *Dictyophora indicum* is tightly polymerized and exhibits strong intermolecular interactions.

[0052] 4. The structure of the polysaccharide from *Dictyophora indicum* was identified. All experimental results were obtained by Jiangnan University, and the results are shown in Tables 3 and 4.

[0053] Table 3. Structure of polysaccharides from *Dictyophora indicum*

[0054]

[0055] The ratio of the four PMAAs (methacrylic acids) in the polysaccharide of *Dictyophora indicum* is Glcp(1:-3)-Glcp-(1:-4)-Glcp-(1:-6)-Glcp-(1-=1∶1∶1∶9.42, of which -6)-Glcp-(1- accounts for as high as 75.80%, indicating that the main chain of *Dictyophora indicum* polysaccharide is linked by -6)-Glcp-(1- bonds, and the branched sugar residues are -3)-Glcp-(1- and -4)-Glcp-(1- glycosidic bonds.

[0056] Table 4. Results of methylation analysis of polysaccharides from *Dictyophora indicum*.

[0057]

[0058] 5. Analysis of the composition and nutritional components of polysaccharides from *Dictyophora indicum*:

[0059] Please have a qualified third-party organization (Guizhou Provincial Institute of Analysis and Testing) conduct the relevant tests. The results are shown in Tables 5 and 6.

[0060] Table 5. Component analysis of polysaccharides from *Dictyophora indicum*.

[0061]

[0062] Table 6. Nutritional composition analysis of polysaccharides from *Dictyophora indicum*.

[0063]

[0064] Example 5

[0065] This embodiment conducts a clinical trial based on a prediabetic population:

[0066] According to the WHO 1999 criteria, prediabetes is defined as a fasting blood glucose (FBG) level of 6.1 mmol / L ≤ FBG < 7.0 mmol / L. The trial enrolled 100 patients aged 20–65 years with type 2 prediabetes, who were randomly assigned to a control group of 5 patients and an intervention group of 95 patients (the intervention group was further divided into 3 subgroups).

[0067] Intervention group 1: 25 people, taking the formulation product of Example 3.

[0068] Intervention group 2: 58 people, who took the same formulation product as control group 1.

[0069] Intervention group 3: 12 people, taking the same formulation product as control group 2.

[0070] The intervention group took the same dose once every morning (34.5g) for 30 days.

[0071] Before the intervention, basic information questionnaires, physical measurements, and biochemical tests, including fasting blood glucose and glycated hemoglobin, were conducted on both the intervention and control groups. On days 7, 14, and 21 of the intervention, random finger-prick blood glucose tests were performed on both groups in the morning (9:00-11:00), noon (13:00-15:00), and evening (18:00-20:00). After the intervention, physical measurements and biochemical tests, including fasting blood glucose and glycated hemoglobin, were conducted on both groups.

[0072] Among the 95 prediabetic patients who received one month of intervention, 86 showed improvement in their fasting blood glucose levels, with an effective rate of 90.53%. The mean fasting blood glucose level decreased from 6.48 mmol / L to 5.28 mmol / L, a reduction of 18.52%. In particular, all patients in intervention group 1 showed a significant decrease in fasting blood glucose, with better improvement than other intervention groups.

[0073] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A composition for targeted regulation of blood sugar with the assistance of red-topped bamboo fungus polysaccharide, characterized in that, The composition comprises, by weight parts: 4-6 parts of red-topped bamboo fungus polysaccharide, 1-2 parts of sandoan, 1-3 parts of theaflavins, 18-22 parts of 7-day sausage, and 5-7 parts of tremella freeze-dried powder; The polysaccharide from *Dictyophora indica* is derived from the volva of *Dictyophora indica*. The Smith degradation product of the polysaccharide contains glycerol, erythritol, arabinose, mannose, and glucose. The polysaccharide contains 1-3 glycosidic bonds, 1-2,3 glycosidic bonds, 1-3,4 glycosidic bonds, 1-3,6 glycosidic bonds, and / or 1-2,3,4 glycosidic bonds. The polysaccharide from *Dictyophora indica* has a three-dimensional helical structure and a weight-average molecular weight of 3.005 × 10⁻⁶. 6 Da.

2. The composition according to claim 1, characterized in that, The composition comprises, by weight parts: 5 parts of red-topped bamboo fungus polysaccharide, 1.5 parts of sandoan, 2 parts of theaflavins, 20 parts of 7-day intestinal health supplement, and 6 parts of lycopene powder of tremella.

3. A method for preparing the composition according to any one of claims 1 to 2, characterized in that, The process includes the following steps: mixing the raw materials sequentially according to the stated proportions to obtain a mixture.

4. The use of the composition according to any one of claims 1 to 2 in the preparation of hypoglycemic products.

5. The application according to claim 4, characterized in that, The products mentioned include health supplements or medicines.

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