Application of beta-1, 3 / alpha-1, 3-glucan in preparation of medicine for treating and / or preventing hypertriglyceridemia and health food beneficial to maintaining health level of triglyceride

Abstract

The invention relates to the technical field of food nutrition and health care and biological medicine, in particular to application of beta-1, 3 / alpha-1, 3-glucan in preparation of a medicine for treating and / or preventing hypertriglyceridemia and health food beneficial to maintaining the health level of triglyceride. Animal experiment results show that blood glucose (GLU) and triglyceride (TG) of low, medium and high dose groups after 8-week administration are obviously reduced (P is less than 0.05 or 0.01), and high-density lipoprotein (HDL-C) of medium and high dose groups of test substances is obviously reduced (P is less than 0.05) compared with a model group. The results indicate that the beta-1, 3 / alpha-1, 3-glucan has obvious effects of reducing blood glucose and reducing triglyceride on a high-glucose and high-fat rat model, and a new direction is provided for preparing the medicine for treating and / or preventing hypertriglyceridemia and health-care food beneficial to maintaining the health level of triglyceride.

Description

Technical Field

[0001] The present invention relates to the fields of food nutrition, health care and biomedicine technology, and in particular to the use of beta-1,3 / alpha-1,3-glucan in the preparation of drugs for treating and / or preventing hypertriglyceridemia and health foods that help maintain healthy triglyceride levels. Background Art

[0002] Hyperlipidemia, commonly known as high blood lipids, refers to elevated blood lipid levels, specifically elevated cholesterol, triglycerides, and low-density lipoprotein (LDL). High blood lipids can directly lead to serious health problems, such as pancreatitis, atherosclerosis, and coronary heart disease. Hypertriglyceridemia is a disorder of triglyceride protein synthesis or degradation. High triglycerides can lead to "thick blood," a condition characterized by excessive lipid levels that thickens the blood. These deposits accumulate on blood vessels, gradually forming small plaques known as atherosclerosis. These plaques gradually expand in size and thickness, reducing the vessel diameter and slowing blood flow. This slowed blood flow accelerates blockage, even leading to severe blood flow interruption. Besides interrupting blood flow, the dislodgment of blockages can also cause thrombosis. The consequences of elevated triglycerides are devastating regardless of where they occur. If it occurs in the heart, it can cause coronary heart disease and myocardial infarction; in the brain, it can cause cerebral infarction and stroke; in the fundus of the eye, it can lead to vision loss and blindness; in the kidneys, it can cause renal failure; and in the lower limbs, it can cause poor blood flow and lead to necrosis. It is a significant risk factor for coronary heart disease, hypertension, diabetes, and other metabolic syndrome-related diseases. Actively controlling high triglycerides is a key component of primary prevention for metabolic syndrome-related diseases.

[0003] β-glucan is a structural non-starch polysaccharide and the most abundant naturally synthesized polysaccharide. It is widely found in the cell walls of yeast, fungi (including mushrooms), some bacteria, seaweed, and grains. β-glucan is further divided into soluble β-glucan and insoluble β-glucan based on its solubility. Most β-glucans are soluble in water due to the presence of β-(1→3) bonds in their molecular structure, thus functioning as soluble dietary fiber. Their bioactive substances can improve animal performance and intestinal flora balance. β-glucan has been shown to promote gastrointestinal motility and the growth of beneficial intestinal bacteria. β-glucans derived from yeast, oats, barley, and other sources are currently approved for use as food ingredients or food additives in several countries, including the United States, Australia, and Japan. In 2006, my country approved curdlan with β-1,3-glucan as its main ingredient as a food additive, and approved yeast β-glucan and oat β-glucan as new food ingredients in 2010 and 2014 respectively.

[0004] β-1,3 / α-1,3-glucan is a new type of water-soluble glucan. It is a linear polysaccharide composed of 9 D-glucose repeating units formed by 7 β-1,3-D-glucose and 2 α-1,3-glucose connected to each other. It is a natural water-soluble extracellular polysaccharide obtained by fermentation of Rhizobium pusha and is completely soluble in water. In 2021, the National Health Commission approved it as a new food ingredient. According to the requirements of the "Announcement on 6 "Three New Foods" Including β-1,3 / α-1,3-Glucan", β-1,3 / α-1,3-glucan is made from sucrose as the main raw material by fermentation of Rhizobium pusha (Rhizobiumpusense), alcohol precipitation, filtration, separation, drying, and crushing. The product content should meet the requirements of β-1,3 / α-1,3-glucan content ≥90 grams and protein ≤3 grams per 100 grams of product; the recommended consumption is ≤3 grams / day.

[0005] The application research on β-1,3 / α-1,3-glucan retrieved by the applicant mainly includes:

[0006] When studying the effects of β-1,3 / α-1,3-glucan on fecal output and small intestinal transit in normal mice and two types of drug-induced constipation mice, Zhou Mengyi et al. found that β-1,3 / α-1,3-glucan has good water retention and swelling effects, which stimulate small intestinal peristalsis and promote defecation; Ning Yichun showed in his study on the regulatory effect of β-1,3 / α-1,3-glucan on intestinal function in mice that β-1,3 / α-1,3-glucan can improve intestinal flora; as a new food ingredient, β-1,3 / α-1,3-glucan has been found to be a prebiotic in the intestine, promoting the growth of beneficial intestinal bacteria and regulating intestinal health; β-1,3 / α-1,3-glucan has high water retention, which allows β-1,3 / α-1,3-glucan to soften feces and facilitate fecal excretion.

[0007] There are no reports on the research on the lipid-lowering effect of β-1,3 / α-1,3-glucan. Summary of the Invention

[0008] The present invention provides the use of β-1,3 / α-1,3-glucan in preparing a medicament for treating and / or preventing hypertriglyceridemia.

[0009] The present invention provides the use of β-1,3 / α-1,3-glucan in the preparation of health-care food that helps maintain healthy triglyceride levels.

[0010] To ensure the safety and lack of toxic side effects after taking β-1,3 / α-1,3-glucan, the selected β-1,3 / α-1,3-glucan meets the requirements for composition, production process, and product quality as specified in the national "Announcement on Six 'Three New Foods' Including β-1,3 / α-1,3-glucan." The aforementioned announcement clearly states that the production strain is Rhizobium pusense. More preferably, the β-1,3 / α-1,3-glucan production process uses Rhizobium pusense, with the Latin name Rhizobium pusense and the deposit number CGMCC No. 19764 or CGMCC No. 12954.

[0011] The substantial features and significant technical advancements of the present invention are:

[0012] 1. Because the country has identified β-1,3 / α-1,3-glucan as a new food ingredient, its effects have been proven to be safe and non-toxic. Compared with existing drugs, it can effectively reduce the toxic side effects caused by taking it.

[0013] 2. Animal experiment results showed that after 8 weeks of administration, blood glucose (GLU) and triglyceride (TG) levels in the low, medium, and high dose groups were significantly reduced (P < 0.05 or 0.01), and high-density lipoprotein (HDL-C) levels in the medium and high dose groups were significantly lower than those in the model group (P < 0.05). These results suggest that β-1,3 / α-1,3-glucan has a significant effect on lowering blood glucose and triglycerides in the high-sugar, high-fat rat model. This invention provides a new direction for the preparation of drugs for the treatment and / or prevention of hypertriglyceridemia and health foods that help maintain healthy triglyceride levels. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 This is a schematic diagram of the effects of β-1,3 / α-1,3-glucan on body weight in male high-sugar and high-fat rats.

[0015] Figure 2 This is a schematic diagram showing the effects of β-1,3 / α-1,3-glucan on body weight in female high-sugar and high-fat rats. DETAILED DESCRIPTION

[0016] The present invention is further described below in conjunction with examples. The examples and descriptions of the present invention are used to explain the present invention, but should not be understood as limiting the present invention. The scope of protection of the present invention is based on the contents recorded in the claims. Any replacement of equivalent technical means made according to the description does not depart from the scope of protection of the present invention.

[0017] Example

[0018] In March 2024, the applicant commissioned the New Drug Safety Evaluation Research Center of Hebei Medical University to conduct a special study on the effects of β-1,3 / α-1,3-glucan on the lipid metabolism of high-sugar and high-fat rats. The test sample β-1,3 / α-1,3-glucan in the special study was provided by Hebei Xinhe Biochemical Co., Ltd.

[0019] 1. Participants in the experiment and the work they undertake

[0020]

[0021] *Indicates the principal person in charge.

[0022] 2. Summary Report

[0023] 2.1 Research Summary

[0024] Objective: To observe the effects of β-1,3 / α-1,3-glucan on glucose and lipid metabolism in rats fed with high sugar and high fat diet, and to provide a reference for human consumption.

[0025] Methods: Forty-four SD rats, 6-7 weeks old, weighing 183.2-220.8 g, and half male and half female, were quarantined and fed for 4 days before the experiment. All rats were then fasted overnight with or without water. Blood was collected from the inner canthus (0.3-0.4 ml / rat) to promote coagulation. Serum cholesterol (TCHO), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C), and blood glucose (GLU) were measured. The rats were randomly divided into five groups based on blood glucose and body weight: a normal control group, a model group, and low-, medium-, and high-dose test substance groups, with 8-10 rats in each group, half male and half female. The normal control group was given a standard rat maintenance diet, and the other groups were given a high-sugar and high-fat diet (67% rat maintenance diet + 10% lard + 20% sucrose + 2.5% cholesterol + 0.5% sodium cholate) to prepare a high-sugar and high-fat rat model. Four weeks later, the rats in the four modeling groups were intraperitoneally injected with 1% streptozotocin (STZ) 35 mg / kg once. On the third day after STZ injection, all animals were fasted overnight but not water, and 0.3-0.4 ml of blood was collected from the inner canthus (procoagulant), and the relevant indicators of glucose and lipid metabolism (TCHO, TG, LDL-C, HDL-C, GLU) were measured. If necessary, an additional injection of STZ and an additional blood glucose test were performed to determine whether the high-sugar and high-fat model was successful. This experiment adopted a preventive administration method. Drug administration started from the first day of model establishment. All animals were administered by gavage. The low, medium and high dose groups of the test substance were given 0.32, 0.768 and 1.536 g / kg β-1,3 / α-1,3-glucan suspension. The normal control group and the model control group were given the same volume of 0.5% CMCNa at a volume of 2 mL / 100 g once a day for 8 weeks. Body weight and food intake were measured twice a week, at the end of the 6th and 8th weeks respectively. After the first administration, all animals were fasted overnight but not water deprived. 0.3-0.4 ml of blood was collected from the inner canthus (procoagulant) to measure serum glucose and lipid metabolism related indicators (TCHO, TG, LDL-C, HDL-C, GLU) to analyze the effects of β-1,3 / α-1,3-glucan on glucose and lipid metabolism in high glucose and high fat rats.

[0026] result:

[0027] Observation of general symptoms: During the experiment, the weight of rats in the normal control group increased steadily, their fur became shiny, and they were active. The fur of rats in the modeling groups became rough, and no other obvious abnormalities were observed.

[0028] Body Weight: Compared with the normal control group, the body weight of male rats in the model control group showed a decreasing trend, but no statistical difference was observed. Female rats showed significant weight increases at multiple time points (P < 0.05 or 0.01). Compared with the model control group, the body weight of male rats in the low-, medium-, and high-dose groups of the test substance showed a decreasing trend, but no statistical difference was observed. Female rats in the low- and medium-dose groups showed significant weight decreases at multiple time points (P < 0.05 or 0.01). This suggests that preventive administration of the test substance can effectively reduce the body weight of rats exposed to high sugar and high fat intake.

[0029] Food intake: Compared with the normal control group, all animals fed a high-fat diet showed a trend toward lower food intake. Compared with the model control group, the low- and medium-dose groups also showed a trend toward lower food intake, while no significant difference was observed in the high-dose group. This suggests that preventive administration of the test substance can effectively reduce food intake in rats.

[0030] Results related to glucose and lipid metabolism: The model created in this experiment was a high-sugar and high-fat rat model. Compared with the normal control group, the total cholesterol (TCHO), triglycerides (TG), low-density lipoprotein (LDL-C) and blood glucose (GLU) of the model control group were significantly increased (P < 0.05 or 0.01), and the high-sugar and high-fat model was successfully established. Compared with the model control group, after 4 weeks of β-1,3 / α-1,3-glucan administration, triglyceride (TG) in the low-dose group, total cholesterol (TCHO), high-density lipoprotein (HDL-C), and blood glucose (GLU) in the high-dose group were significantly reduced (P < 0.05). After 1 week of continued administration, blood glucose in the low, medium, and high-dose groups was significantly reduced (P < 0.05). After 6 weeks of administration, blood glucose (GLU) in the low, medium, and high-dose groups decreased in a dose-dependent manner (P < 0.05 or 0.01), and triglyceride (TG) and high-density lipoprotein (HDL-C) in the high-dose group were significantly reduced (P < 0.05). After 8 weeks of administration, blood glucose (GLU) and triglyceride (TG) in the low, medium, and high-dose groups were significantly reduced (P < 0.05 or 0.01), and high-density lipoprotein (HDL-C) in the medium and high-dose groups was significantly lower than that in the model group (P < 0.05). The above results suggest that β-1,3 / α-1,3-glucan has a significant effect of lowering blood sugar and triglycerides in the high-sugar and high-fat rat model.

[0031] in conclusion:

[0032] Under the experimental conditions of this study, β-1,3 / α-1,3-glucan, provided by Hebei Xinhe Biochemical Co., Ltd., was administered orally daily for eight weeks to rats exposed to high-sugar and high-fat diets. Preventive administration effectively reduced food intake and body weight, and demonstrated significant hypoglycemic and triglyceride-lowering effects. The effective dose (0.32g / kg) is equivalent to 6.5 times the recommended human intake per kilogram of body weight and 1 times the recommended human intake per body surface area.

[0033] 2.2 Experimental Purpose

[0034] β-1,3 / α-1,3-glucan was provided by Hebei Xinhe Biochemical Co., Ltd. Its main ingredient is β-1,3 / α-1,3-glucan, made from sucrose through fermentation with Rhizobium pusaense, alcohol precipitation, filtration, separation, drying, and pulverization. This study aimed to observe its effects on glucose and lipid metabolism in rats fed a high-sugar and high-fat diet, providing a reference for human consumption.

[0035] 2.3 Materials and Methods

[0036] 2.3.1 Test and reference article information

[0037] 2.3.1.1 Test substance information

[0038]

[0039]

[0040] 2.3.1.2 Solvent Reference Material Information

[0041] Chinese name: Sodium carboxymethyl cellulose Batch number: 20230701

[0042] Molecular formula: (fill in chemical drugs) or main components: C6H7O2(OH)2OCH2COONa

[0043] Manufacturer: Tianjin Damao Chemical Reagent Factory

[0044] Preparation and Concentration: Accurately weigh 5g of sodium carboxymethyl cellulose and pour it into a 1L volumetric flask. Add approximately 700ml of ultrapure water. Cap the flask and ultrasonicate for 3 hours. After cooling, add ultrapure water to 1L to achieve a concentration of 0.5%. Place in a 1L reagent bottle and prepare once a week.

[0045] 2.3.2 Main Experiment Dates

[0046] 2024-03-15 Animals entering the house 2024-03-19 Clinical detection and grouping 2024-03-19～2024-04-18 Modeling and preventive medication 2024-04-18、2024-04-23 Clinical testing 2024-04-19～2024-05-13 Drug administration 2024-05-13 Clinical testing 2024-05-16 <![CDATA[Animal handling (CO2)]]>

[0047] 2.3.3 Main instruments and reagents

[0048] 2.3.3.1 Main instruments

[0049] Instrument name model Manufacturer Pure water / ultrapure water system PLUS-E2-20TJ Nanjing Yipu Yida Technology Development Co., Ltd. Fully automatic biochemical analyzer HITACHI 7180 Japan HITACHI blood glucose meter ONETOUCH Verio Flex Wenjie Company centrifuge 5415D Eppendorf electronic balance Practum224-1cn Sartorius Scientific Instruments Co., Ltd. electronic balance JJ2000 American Shuangjie Group Co., Ltd. electronic balance TD210 Jinnuo Balance Instrument Co., Ltd.

[0050] 2.3.3.2 Main reagents

[0051] Streptozotocin (STZ): Purchased from Beijing Solaibao Biotechnology Co., Ltd., 1 g / bottle, Lot No. 24240306009, expiration date 20260307, stored at −20°C. Prepare a 1% solution in citric acid buffer (pH 4.5) before use, place in an ice bath in the dark, and administer by intraperitoneal injection within 30 minutes.

[0052] 0.1 M sodium citrate buffer (sterile): purchased from Beijing Solebow Biotechnology Co., Ltd., 500 mL / bottle, pH 4.5, Lot No. 240002002, valid until 20250219.

[0053] 2.3.4 Experimental animals and feeding conditions

[0054] 2.3.4.1 Experimental animals

[0055]

[0056] *: This experiment and the special topic NPJ-202407-PHD2 share the normal control group and model control group, and the number of animals is the total number of animals in the two special topics.

[0057] 2.3.4.2 Identification methods of experimental animals

[0058] Upon arrival, experimental animals were received and quarantined according to the Animal Receiving and Quarantine SOP. Each animal was assigned a unique sex number (males: M01, M02, M03, etc.; females: F01, F02, F03, etc.). Picric acid was used to label the animals according to the SOP, and the animal number was used for identification in the original documentation.

[0059] 2.3.4.3 Animal breeding conditions

[0060] During the experiment, the animals were housed in laboratory W6 at a temperature of 19-26°C, relative humidity of 40-70%, with 12 hours of light and 12 hours of darkness. They were housed in rat-specific feeding boxes and fed regularly and in fixed amounts, with free access to food and water. Feed consisted of standard rat chow and a high-sugar, high-fat diet (67% rat maintenance feed + 10% lard + 20% sucrose + 2.5% cholesterol + 0.5% sodium cholate) provided by Keao Xieli (Tianjin) Feed Co., Ltd., meeting national standards. Drinking water was sterile, homemade in the laboratory.

[0061] 2.3.5 Dosage design

[0062] 2.3.5.1 Design basis

[0063] The maximum recommended dietary intake of β-1,3 / α-1,3-glucan provided by the client is 3g / 60kg / day. Based on the dissolution test results of our laboratory, three doses of the test substance were set: 0.32g / kg for the low, medium, and high doses of β-1,3 / α-1,3-glucan, 0.768g / kg, 0.768g / kg, and 1.536g / kg, respectively. These doses, when converted per kilogram of body weight, are equivalent to 6.5 times, 15.5 times, and 31 times the recommended dietary intake, respectively; and when converted per body surface area, they are equivalent to 1 times, 2.4 times, and 4.8 times the recommended dietary intake, respectively.

[0064] 2.3.5.2 Dose group design

[0065]

[0066] 2.3.5.3 Experimental Animal Grouping Design

[0067] Forty-four SD rats that passed the quarantine were selected, half male and half female, and randomly divided into five groups according to blood glucose and body weight indicators, namely normal control group, model control group, low-dose, medium-dose and high-dose test substance groups, with 8 to 10 rats in each group.

[0068]

[0069] 2.3.6 Route and method of administration

[0070] Route of administration: Oral administration

[0071] Dosage volume: 20mL / kg

[0072] Dosing frequency: once a day

[0073] Administration date: March 19, 2024 to May 13, 2024

[0074] 2.3.7 Observation indicators and methods

[0075] Body weight: Weigh the animals twice a week and record the changes in their body weight.

[0076] Food intake: According to the specific food intake growth, a fixed amount of feed was given to each cage, and the remaining amount was weighed twice a week to calculate the daily intake of each rat. Intake = (fixed food intake) Remaining food) / number of animals per cage / day.

[0077] Blood glucose and blood lipid related indices: 0.3-0.4 mL of blood was collected from the inner canthus (to promote coagulation) before grouping, 4 weeks + 3 days after modeling, 5 weeks after drug administration (blood glucose measurement with a blood glucose meter), 6 weeks after drug administration, and at the end of 8 weeks after drug administration, and the following blood glucose and blood lipid related indices were measured.

[0078] Test items abbreviation unit Detection method Reagent Source Testing instrument (model, name) blood sugar GLU mmol / L Hexokinase method Sysmex CHEMIX-180 fully automatic biochemical analyzer Total cholesterol T-CHO mmol / L Cholesterol dehydrogenase method Sysmex CHEMIX-180 fully automatic biochemical analyzer triglycerides TG mmol / L GK-GPO method Sysmex CHEMIX-180 fully automatic biochemical analyzer low-density lipoprotein LDL-C mmol / L Surfactant removal method Sysmex CHEMIX-180 fully automatic biochemical analyzer high-density lipoprotein HDL-C mmol / L selective suppression Sysmex CHEMIX-180 fully automatic biochemical analyzer

[0079] 2.3.8 Statistical methods

[0080] In this study, all blood biochemistry results were collected automatically and printed out by computer. The remaining raw data were recorded manually. Excel software and GraphPad Instat were used to process and statistically analyze the experimental data in accordance with the SOP for statistical analysis of experimental data. GraphPad Prism software was used for experimental drawing.

[0081] For normally distributed quantitative data, if the variances are equal, a t-test or analysis of variance (Dunnet's test if there is a significant difference) is performed between each dose group and the control group. If the variances are unequal, a t-test is performed between each dose group and the control group. For non-normally distributed quantitative data or quantitative data with unequal variances after data transformation, non-parametric tests such as the rank sum test are used. For count data, a chi-square test is performed.

[0082] 2.4 Results

[0083] 2.4.1 General symptom observation

[0084] Before dosing, the animals in each group developed normally, had glossy fur, consumed food and water normally, had no loose stools, no abnormal secretions, and were active. During the modeling and dosing period, no animals died. The normal group had stable weight gain, glossy fur, and agile activity. The rats in the modeling groups had coarse fur, and no other significant abnormalities were observed.

[0085] 2.4.2 Effects on body weight, see Tables 1.1 to 1.2. Figures 1-2

[0086] During the modeling and drug administration period, the body weight of rats in the normal control group increased steadily;

[0087] Model control group: Compared with the normal control group, the body weight of female rats increased significantly on the 8th to 25th day and the 39th day of modeling (P < 0.05 or 0.01), while no significant difference was found in the body weight of male animals;

[0088] Low-dose group: Compared with the normal control group, the body weight of male rats decreased significantly from the 4th day of administration (P < 0.05 or 0.01); compared with the model control group, the body weight of female rats decreased significantly from the 11th to the 15th day, the 25th day, and the 39th day of administration (P < 0.05), and no significant differences were observed in other groups.

[0089] Medium-dose group: Compared with the normal control group, the body weight of male rats was significantly decreased on days 18 to 32, 50, and 56 of administration (P < 0.05 or 0.01), and the body weight of female rats was significantly decreased on day 15 (P < 0.05); compared with the model control group, the body weight of female rats was significantly decreased on days 8 to 15 and 25 to 39 of administration (P < 0.05 or 0.01), and no significant differences were observed in other groups.

[0090] High-dose group: Compared with the normal control group, the body weight of male rats decreased significantly from the 4th day of administration (P < 0.05 or 0.01); compared with the model control group, no significant difference was found in both male and female rats.

[0091] Summary: Compared with the normal control group, the body weight of male rats in the model control group showed a decreasing trend, but no statistical difference was observed. Female rats showed significant weight gain at multiple time points (P < 0.05 or 0.01). Compared with the model control group, the body weight of male rats in the low-, medium-, and high-dose groups of the test substance all showed a decreasing trend, but no statistical difference was observed. Female rats in the low- and medium-dose groups showed significant weight loss at multiple time points (P < 0.05 or 0.01). This suggests that preventive administration of the test substance can effectively reduce the body weight of rats exposed to high sugar and high fat intake.

[0092] 2.4.3 Effect on food intake, see Tables 2.1 to 2.2

[0093] Compared with the normal control group, which was fed a normal diet, all rats fed a high-fat diet showed a trend toward lower food intake. Compared with the model control group, the food intake of rats in the low- and medium-dose test substance groups also showed a trend toward lower food intake, while no significant difference was observed in the high-dose group. This suggests that preventive administration of the test substance can effectively reduce food intake in rats.

[0094] 2.4.4 Effects on glucose and lipid metabolism related indicators in rats, see Tables 3.1 to 3.4

[0095] Before modeling: blood glucose (GLU), total cholesterol (TCHO) and triglyceride (TG) in each experimental group were basically similar, with no significant differences.

[0096] At 4 weeks after modeling, compared with the normal control group, the model control group had significantly increased levels of total cholesterol (TCHO), triglycerides (TG), low-density lipoprotein (LDL-C), and blood glucose (GLU) (P < 0.05 or 0.01), indicating successful establishment of a high-sugar, high-fat model. Compared with the model control group, the low-dose group had significantly decreased levels of triglycerides (TG), and the high-dose group had significantly decreased levels of total cholesterol (TCHO), high-density lipoprotein (HDL-C), and blood glucose (GLU) (P < 0.05).

[0097] After supplementary injection of STZ: compared with the normal control group, the blood glucose of the model control group was significantly increased (P<0.01); compared with the model control group, the blood glucose (GLU) of the low, medium and high dose groups of the test substance were significantly decreased (P<0.05).

[0098] At the end of 6 weeks of administration: compared with the normal control group, the total cholesterol (TCHO), triglycerides (TG), low-density lipoprotein (LDL-C) and blood glucose (GLU) of the model control group were significantly increased (P < 0.05 or 0.01); compared with the model control group, the blood glucose (GLU) of the low, medium and high dose groups of the test substance showed a dose-dependent decrease (P < 0.05 or 0.01), and the triglycerides (TG) and high-density lipoprotein (HDL-C) of the high dose group of the test substance were significantly decreased (P < 0.05).

[0099] At the end of 8 weeks of administration: compared with the normal control group, the total cholesterol (TCHO), triglyceride (TG), low-density lipoprotein (LDL-C) and blood glucose (GLU) of the model control group were significantly increased (P < 0.05 or 0.01); compared with the model control group, the blood glucose (GLU) and triglyceride (TG) of the low, medium and high dose groups of the test substance were significantly decreased (P < 0.05 or 0.01), and the high-density lipoprotein (HDL-C) of the medium and high dose groups of the test substance were significantly lower than that of the model group (P < 0.05).

[0100] Summary: The model created in this experiment is a high-sugar and high-fat rat model. Compared with the normal control group, the total cholesterol (TCHO), triglycerides (TG), low-density lipoprotein (LDL-C) and blood glucose (GLU) of the model control group were significantly increased (P < 0.05 or 0.01), and the high-sugar and high-fat model was successfully prepared. Compared with the model control group, after 4 weeks of β-1,3 / α-1,3-glucan administration, triglyceride (TG) in the low-dose group, total cholesterol (TCHO), high-density lipoprotein (HDL-C), and blood glucose (GLU) in the high-dose group were significantly reduced (P < 0.05). After 1 week of continued administration, blood glucose in the low, medium, and high-dose groups was significantly reduced (P < 0.05). After 6 weeks of administration, blood glucose (GLU) in the low, medium, and high-dose groups decreased in a dose-dependent manner (P < 0.05 or 0.01), and triglyceride (TG) and high-density lipoprotein (HDL-C) in the high-dose group were significantly reduced (P < 0.05). After 8 weeks of administration, blood glucose (GLU) and triglyceride (TG) in the low, medium, and high-dose groups were significantly reduced (P < 0.05 or 0.01), and high-density lipoprotein (HDL-C) in the medium and high-dose groups was significantly lower than that in the model group (P < 0.05). The above results suggest that β-1,3 / α-1,3-glucan has a significant effect of lowering blood sugar and triglycerides in the high-sugar and high-fat rat model, but has no obvious effect on lowering total cholesterol.

[0101] 2.5 Discussion and Analysis

[0102] This study initially aimed to investigate the effects of β-1,3 / α-1,3-glucan on glucose and lipid metabolism in rats with type 2 diabetes. However, because blood glucose levels did not rise to the level of type 2 diabetes after two STZ-induced treatments, given the established high-glucose, high-fat model, the study shifted to evaluating the effects of β-1,3 / α-1,3-glucan on glucose and lipid metabolism in rats with high glucose and high fat. Continuous administration for eight weeks demonstrated that β-1,3 / α-1,3-glucan significantly reduced blood glucose and triglycerides in rats with high glucose and high fat. Due to limitations in the modeling methods and dosing schedule of this study, direct evidence of a reduction in total cholesterol was not obtained. We believe that with further research, further findings may be discovered.

[0103] 2.6 Conclusion

[0104] Under the experimental conditions of this study, β-1,3 / α-1,3-glucan, provided by Hebei Xinhe Biochemical Co., Ltd., was administered orally daily for eight weeks to rats exposed to high-sugar and high-fat diets. Preventive administration effectively reduced food intake and body weight, and demonstrated significant hypoglycemic and triglyceride-lowering effects. The effective dose (0.32g / kg) is equivalent to 6.5 times the recommended human intake per kilogram of body weight and 1 times the recommended human intake per body surface area.

[0105] 2.7 References

[0106] ① Zhang Hongyan, Ruan Jun, Wu Fang, et al. Effects of Fengliao Changweikang Granules on Glucose and Lipid Metabolism and GLP-1 in Obesity-Induced Type 2 Diabetic Rats[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2023, 32(4): 490-495.

[0107] ② Li Ya, Wu Qiong, Ma Xiaoyu, et al. Influencing factors of high-fat diet and streptozotocin in establishing type 2 diabetic rat model[J]. Journal of Heze Medical College, 2020, 32(1): 91-93.

[0108] ③Li Chengjia, Liu Zhiping, Liu Yingzhe, et al. Effects and mechanisms of Zikuiyin on liver glucose and lipid metabolism in rats with type 2 diabetes [J]. Chinese Medicinal Materials, 2023, 46(11): 2818-2824.

[0109] ④ Ma Nana, Han Lijuan, Yang Yongjing, Suo Yourui, Yuan Zhenzhen, Ye Ying. Regulatory effects of polysaccharides from Flaveria spinulosa on glucose and lipid metabolism in STZ-induced type 1 diabetic rats [J / OL]. Food Engineering Technology. https: / / doi.org / 10.13386 / j.issn1002-0306.2023090056

[0110] ⑤ Technical Guidelines for Functional Testing and Evaluation of Health Foods (2022 Edition)

[0111] ⑥ Health Food Function Testing and Evaluation Methods (2023 Edition)

[0112] ⑦ Document No. 5 of 2021 of the National Health Commission

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Claims

1. Use of β-1,3 / α-1,3-glucan in the preparation of a medicament for treating and / or preventing hypertriglyceridemia.

2. Application of β-1,3 / α-1,3-glucan in the preparation of health foods that help maintain healthy triglyceride levels.

3. The use according to claim 1 or 2, characterized in that The selected β-1,3 / α-1,3-glucan meets the requirements for its ingredients, production process and product quality in the "Announcement on Six "Three New Foods" Including β-1,3 / α-1,3-glucan" issued by the National Health Commission.

4. The use according to claim 3, characterized in that The production strain used in the production process of β-1,3 / α-1,3-glucan is Rhizobium pusa, whose Latin name is Rhizobiumpusense and whose preservation number is CGMCC No.19764 or CGMCC No.12954.

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