Ackermann bacteria tablet for reducing blood sugar and preparation method of ackermann bacteria tablet
By hiding the human symbiotic anaerobic bacterial mass in blood sugar-lowering tablets, the problem that existing drugs are difficult to maintain the stability of the gastrointestinal flora is solved, and the effect of effectively lowering glucose and preventing complications is achieved, while reducing the occurrence of gastrointestinal diseases.
Patent Information
- Application Number
- CN202510210323.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-02-25
- Publication Date
- 2025-04-15
AI Technical Summary
Existing blood sugar-lowering drugs are difficult to maintain the stability of the gastrointestinal environment, which can easily lead to gastrointestinal flora disorders, and thus trigger new gastrointestinal symptoms.
Microcapsule pre-prepared materials are used to embed symbiotic anaerobic bacterial groups in the human body, and Akermania tablets are obtained through tableting to ensure the stability of the bacterial population in the gastrointestinal tract.
Effectively lowers glucose, prevents the occurrence of complications of diabetes, maintains the stability of gastrointestinal flora, and reduces the incidence of secondary gastrointestinal diseases.
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Abstract
Description
Technical Field
[0001] The invention relates to the technical field of hypoglycemic drugs, and in particular to a hypoglycemic Akkermansia tablet and a preparation method thereof. Background Art
[0002] Diabetes is an endocrine metabolic disease characterized by absolute or relative insulin deficiency and glucose metabolism disorder. It is a common disease that endangers human health. The clinical manifestations of diabetes are weight loss, fatigue, and hunger and excessive eating. It is easy to develop chronic lesions of the cardiovascular, cerebrovascular, kidney, retinal and nervous systems, and even cause blindness and disability, seriously affecting health and work and living ability.
[0003] Although existing hypoglycemic drugs can lower blood sugar and reduce the occurrence of complications, most of the hypoglycemic drugs currently used cannot maintain the stability of the gastrointestinal environment well, and can easily cause imbalance of the patient's gastrointestinal flora, leading to the emergence of new gastrointestinal symptoms. Summary of the invention
[0004] In order to overcome the above-mentioned defects of the existing hypoglycemic drugs, the present invention provides a new hypoglycemic Akkermansia tablet.
[0005] Specifically, the present invention provides an Akkermansia tablet for reducing blood sugar, wherein the Akkermansia tablet is obtained by encapsulating a human symbiotic anaerobic bacterial mass in a microcapsule preform and then tabletting, wherein: The raw materials for preparing the microcapsule preform include, by weight: 20-25 parts of sodium alginate, 6-10 parts of pectin, 10-18 parts of chitosan and 8-13 parts of sugar-free xylitol; The raw materials for preparing the human body symbiotic anaerobic bacterial group include, by weight: 60-80 parts of Akkermansia muciniphila, 45-60 parts of Lactobacillus and 30-40 parts of Bifidobacterium.
[0006] Furthermore, in the blood sugar lowering Akkermansia tablets of the present invention, the raw materials for preparing the microcapsule preform further include, by weight: 20-35 parts of a dissolving agent and 10-15 parts of a thickening agent.
[0007] Preferably, in the raw materials for preparing the blood sugar-lowering Akkermansia tablets of the present invention, the dissolving agent is citric acid or tartaric acid.
[0008] Preferably, in the raw materials for preparing the blood sugar-lowering Akkermansia tablets of the present invention, the raw materials for preparing the thickener include, by weight: 3-5 parts of soybean peptide powder, 6-9 parts of maltose, 10-15 parts of inactivated edible lactic acid bacteria powder and 8-10 parts of casein hydrolyzed peptides; The preparation process of the thickener is as follows: soybean peptide powder, maltose, inactivated edible lactic acid bacteria powder and casein hydrolyzed peptide in a prescribed amount are mixed, and the thickener is obtained after being stirred evenly.
[0009] Furthermore, in the blood sugar lowering Akkermansia tablets of the present invention, the preparation process of the microcapsule preform comprises the following steps: (1) Mixing the formulated amounts of sodium alginate, pectin, chitosan and sugar-free xylitol and heating to dissolve them at 60-85° C. to obtain a mixture; (2) dissolving the mixture in a solvent and stirring uniformly to obtain a solution; (3) Add a thickener to the solution and stir evenly to obtain a microcapsule preform.
[0010] Furthermore, in the blood sugar lowering Akkermansia tablets of the present invention, the preparation process of the human symbiotic anaerobic bacterial mass is: after mixing the formulated amounts of Akkermansia muciniphila, Lactobacillus and Bifidobacterium, stirring at low temperature in an environment of -2-6°C is performed, and after fully mixing, the human symbiotic anaerobic bacterial mass is obtained.
[0011] Furthermore, the blood sugar lowering Akkermansia tablets of the present invention are prepared by the following method: S1. The microcapsule preform is embedded in the outer side of the human symbiotic anaerobic bacteria group by an embedding method to obtain a drug group; S2. The drug mass is compressed into tablets by a tableting process to obtain microcapsules, which are Akkermansia tablets.
[0012] Preferably, in the preparation method of the Akkermansia tablets for reducing blood sugar of the present invention, the mass ratio of the microcapsule preform used to the human body symbiotic anaerobic bacteria group is 1.2:1.
[0013] The beneficial effect of the present invention is that the present invention obtains a drug mass by embedding a human symbiotic anaerobic bacterial mass with a microcapsule preform, and then obtains an Akkermansia tablet by tabletting, which can effectively reduce blood sugar and prevent the occurrence of diabetic complications. In addition, the number of viable bacteria in the microcapsules of the Akkermansia tablets of the present invention reaches 1.57x10~7CFU / g after 4 weeks, which is higher than the minimum sales standard of 10~7CFU / g for probiotic preparations of the International Dairy Federation. Therefore, the Akkermansia tablets of the present invention, as an important way to ensure the activity of Akkermansia muciniphila, can significantly increase the effect of the drug, maintain the stability of the gastrointestinal flora of patients, and reduce the incidence of secondary gastrointestinal diseases. DETAILED DESCRIPTION
[0014] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described in conjunction with specific embodiments below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. The present invention can also be implemented or applied through other different specific implementation methods. The details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. At the same time, it should be understood that the scope of protection of the present invention is not limited to the specific specific implementation methods described below; it should also be understood that the terms used in the embodiments of the present invention are for describing specific specific implementation methods, not for limiting the scope of protection of the present invention.
[0015] When the embodiments give numerical ranges, it should be understood that, unless otherwise specified in the present invention, the two endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical terms used in the present invention have the same meaning as those generally understood by those skilled in the art. In addition to the specific methods, equipment, and materials used in the embodiments, according to the grasp of the prior art by those skilled in the art and the record of the present invention, any method, equipment, and material of the prior art similar or equivalent to the methods, equipment, and materials described in the embodiments of the present invention can also be used to realize the present invention.
[0016] In the present invention, unless otherwise specified, all parts and percentages are by weight, and unless otherwise specified, all equipment and raw materials are commercially available or commonly used in the industry. The methods in the following embodiments are conventional methods in the art unless otherwise specified.
[0017] Example 1 The preparation process of the thickener is as follows: 3 parts of soybean peptide powder, 6 parts of maltose, 10 parts of inactivated edible lactic acid bacteria powder and 8 parts of casein hydrolyzed peptide are mixed, and stirred evenly to obtain the thickener; The preparation process of the microcapsule preform is as follows: (1) 20 parts of sodium alginate, 6 parts of pectin, 10 parts of chitosan and 8 parts of sugar-free xylitol are mixed and heated to dissolve at 60°C to obtain a mixture; (2) the mixture is dissolved in 20 parts of citric acid and stirred to obtain a solution; (3) 10 parts of a thickener are added to the solution and stirred to obtain a microcapsule preform; The preparation process of the human symbiotic anaerobic bacterial mass is as follows: 60 parts of Akkermansia muciniphila, 45 parts of Lactobacillus and 30 parts of Bifidobacterium are mixed and stirred at low temperature under a -2°C environment, and the human symbiotic anaerobic bacterial mass is obtained after being fully mixed; The microcapsule preform is embedded in the outside of the human symbiotic anaerobic bacteria group by an embedding method (the mass ratio of the microcapsule preform to the human symbiotic anaerobic bacteria group is 1.2:1) to obtain a drug group; The tableting process is adopted to tablet the drug mass to obtain microcapsules, and the obtained microcapsules are Akkermansia tablets.
[0018] Example 2 The preparation process of the thickener is as follows: 4 parts of soybean peptide powder, 7 parts of maltose, 13 parts of inactivated edible lactic acid bacteria powder and 9 parts of casein hydrolyzed peptide are mixed, and stirred evenly to obtain the thickener; The preparation process of the microcapsule preform is as follows: (1) 22 parts of sodium alginate, 8 parts of pectin, 13 parts of chitosan and 10 parts of sugar-free xylitol are mixed and heated to dissolve at 70°C to obtain a mixture; (2) the mixture is dissolved in 25 parts of citric acid and stirred to obtain a solution; (3) 12 parts of a thickener are added to the solution and stirred to obtain a microcapsule preform; The preparation process of the human symbiotic anaerobic bacterial mass is as follows: 70 parts of Akkermansia muciniphila, 52 parts of Lactobacillus and 35 parts of Bifidobacterium are mixed and stirred at low temperature at 2°C, and the human symbiotic anaerobic bacterial mass is obtained after being fully mixed; The microcapsule preform is embedded in the outside of the human symbiotic anaerobic bacteria group by an embedding method (the mass ratio of the microcapsule preform to the human symbiotic anaerobic bacteria group is 1.2:1) to obtain a drug group; The tableting process is adopted to tablet the drug mass to obtain microcapsules, and the obtained microcapsules are Akkermansia tablets.
[0019] Example 3 The preparation process of the thickener is as follows: 5 parts of soybean peptide powder, 9 parts of maltose, 15 parts of inactivated edible lactic acid bacteria powder and 10 parts of casein hydrolyzed peptide are mixed, and stirred evenly to obtain the thickener; The preparation process of the microcapsule preform is as follows: (1) 25 parts of sodium alginate, 10 parts of pectin, 18 parts of chitosan and 13 parts of sugar-free xylitol are mixed and heated to dissolve at 85°C to obtain a mixture; (2) the mixture is dissolved in 35 parts of citric acid and stirred to obtain a solution; (3) 15 parts of a thickener are added to the solution and stirred to obtain a microcapsule preform; The preparation process of the human symbiotic anaerobic bacterial mass is as follows: 80 parts of Akkermansia muciniphila, 60 parts of Lactobacillus and 40 parts of Bifidobacterium are mixed and stirred at low temperature under 6°C environment, and the human symbiotic anaerobic bacterial mass is obtained after being fully mixed; The microcapsule preform is embedded in the outside of the human symbiotic anaerobic bacteria group by an embedding method (the mass ratio of the microcapsule preform to the human symbiotic anaerobic bacteria group is 1.2:1) to obtain a drug group; The tableting process is adopted to tablet the drug mass to obtain microcapsules, and the obtained microcapsules are Akkermansia tablets.
[0020] Comparative Example 1 The preparation process of the thickener is as follows: 5 parts of soybean peptide powder, 9 parts of maltose, 15 parts of inactivated edible lactic acid bacteria powder and 10 parts of casein hydrolyzed peptide are mixed, and stirred evenly to obtain the thickener; The preparation process of the microcapsule preform is as follows: (1) 10 parts of pectin, 43 parts of chitosan and 13 parts of sugar-free xylitol are mixed and heated to dissolve at 85°C to obtain a mixture; (2) the mixture is dissolved in 35 parts of citric acid and stirred to obtain a solution; (3) 15 parts of a thickener are added to the solution and stirred to obtain a microcapsule preform; The preparation process of the human symbiotic anaerobic bacterial mass is as follows: 80 parts of Akkermansia muciniphila, 60 parts of Lactobacillus and 40 parts of Bifidobacterium are mixed and stirred at low temperature under 6°C environment, and the human symbiotic anaerobic bacterial mass is obtained after being fully mixed; The microcapsule preform is embedded in the outside of the human symbiotic anaerobic bacteria group by an embedding method (the mass ratio of the microcapsule preform to the human symbiotic anaerobic bacteria group is 1.2:1) to obtain a drug group; The tableting process is adopted to tablet the drug mass to obtain microcapsules, and the obtained microcapsules are Akkermansia tablets.
[0021] Comparative Example 2 The preparation process of the thickener is as follows: 5 parts of soybean peptide powder, 9 parts of maltose, 15 parts of inactivated edible lactic acid bacteria powder and 10 parts of casein hydrolyzed peptide are mixed, and stirred evenly to obtain the thickener; The preparation process of the microcapsule preform is as follows: (1) 43 parts of sodium alginate, 10 parts of pectin and 13 parts of sugar-free xylitol are mixed and heated to dissolve at 85°C to obtain a mixture; (2) the mixture is dissolved in 35 parts of citric acid and stirred to obtain a solution; (3) 15 parts of a thickener are added to the solution and stirred to obtain a microcapsule preform; The preparation process of the human symbiotic anaerobic bacterial mass is as follows: 80 parts of Akkermansia muciniphila, 60 parts of Lactobacillus and 40 parts of Bifidobacterium are mixed and stirred at low temperature under 6°C environment, and the human symbiotic anaerobic bacterial mass is obtained after being fully mixed; The microcapsule preform is embedded in the outside of the human symbiotic anaerobic bacteria group by an embedding method (the mass ratio of the microcapsule preform to the human symbiotic anaerobic bacteria group is 1.2:1) to obtain a drug group; The tableting process is adopted to tablet the drug mass to obtain microcapsules, and the obtained microcapsules are Akkermansia tablets.
[0022] Comparative Example 3 The preparation process of the thickener is as follows: 5 parts of soybean peptide powder, 9 parts of maltose, 15 parts of inactivated edible lactic acid bacteria powder and 10 parts of casein hydrolyzed peptide are mixed, and stirred evenly to obtain the thickener; The preparation process of the microcapsule preform is as follows: (1) 25 parts of sodium alginate, 10 parts of pectin, 18 parts of chitosan and 13 parts of sugar-free xylitol are mixed and heated to dissolve at 85°C to obtain a mixture; (2) the mixture is dissolved in 35 parts of citric acid and stirred to obtain a solution; (3) 15 parts of a thickener are added to the solution and stirred to obtain a microcapsule preform; The preparation process of the human symbiotic anaerobic bacterial mass is as follows: 110 parts of Akkermansia muciniphila and 70 parts of Bifidobacterium are mixed and stirred at low temperature under 6°C environment, and the human symbiotic anaerobic bacterial mass is obtained after being fully mixed; The microcapsule preform is embedded in the outside of the human symbiotic anaerobic bacteria group by an embedding method (the mass ratio of the microcapsule preform to the human symbiotic anaerobic bacteria group is 1.2:1) to obtain a drug group; The tableting process is adopted to tablet the drug mass to obtain microcapsules, and the obtained microcapsules are Akkermansia tablets.
[0023] Comparative Example 4 The preparation process of the thickener is as follows: 10 parts of maltose, 17 parts of inactivated edible lactic acid bacteria powder and 12 parts of casein hydrolyzed peptide are mixed, and stirred evenly to obtain the thickener; The preparation process of the microcapsule preform is as follows: (1) 25 parts of sodium alginate, 10 parts of pectin, 18 parts of chitosan and 13 parts of sugar-free xylitol are mixed and heated to dissolve at 85°C to obtain a mixture; (2) the mixture is dissolved in 35 parts of citric acid and stirred to obtain a solution; (3) 15 parts of a thickener are added to the solution and stirred to obtain a microcapsule preform; The preparation process of the human symbiotic anaerobic bacterial mass is as follows: 80 parts of Akkermansia muciniphila, 60 parts of Lactobacillus and 40 parts of Bifidobacterium are mixed and stirred at low temperature under 6°C environment, and the human symbiotic anaerobic bacterial mass is obtained after being fully mixed; The microcapsule preform is embedded in the outside of the human symbiotic anaerobic bacteria group by an embedding method (the mass ratio of the microcapsule preform to the human symbiotic anaerobic bacteria group is 1.2:1) to obtain a drug group; The tableting process is adopted to tablet the drug mass to obtain microcapsules, and the obtained microcapsules are Akkermansia tablets.
[0024] Akkermansia tablets performance test 1.1. Testing the glucose tolerance of Akkermansia tablets of the present invention on normal mice 70 mice were randomly divided into 7 groups, 10 mice in each group, and fasted for 14 hours before intraperitoneal injection of 2% alloxan (200 mg / kg) in saline solution. 72 hours after injection, the mice were divided into groups according to Table 1. The drugs were administered according to Table 1 for 7 consecutive days. The mice were fasted for 8 hours before the last administration. Starch (5 g / kg) was administered intragastrically at the same time as the administration. The blood sugar levels were measured at 0.2 hours, 0.5 hours, 1 hour, 2 hours, and 3 hours after the administration of starch. Blood was collected from the orbital venous sinus and the blood sugar levels were measured using the glucose oxidase test paper method. The results are shown in Table 1: Table 1 Results of glucose tolerance test in normal mice
[0025] It can be seen from the above test results that the Akkermansia tablets produced by the methods of Examples 1-3 of the present invention can inhibit the increase in blood sugar after a meal in normal mice. Mice with blood sugar higher than 11.1 mmol / L are diabetic model mice, among which the blood sugar-lowering result of Example 3 is the best.
[0026] By comparing Comparative Examples 1-4 with Example 3, it can be found that the chitosan, sodium alginate, lactobacillus and soybean peptide powder lacking in Comparative Examples 1-4 more or less affected the glucose tolerance results of mice. Therefore, it can be judged that the chitosan, sodium alginate, lactobacillus and soybean peptide powder in the formula of Example 3 played a role of mutual coordination. The mice using the drug of Example 3 still did not belong to the diabetic model mice after 3 hours, thereby confirming that the drug of Example 3 can achieve the effect of stabilizing blood sugar.
[0027] 1.2. The in vitro simulated digestion system produced by Shanghai Ruiying International Trade Co., Ltd. was used to test the bacterial survival rate in the Akkermansia tablets of the present invention, wherein the temperature was set at 4° C. The test results are shown in Table 2: Table 2 Bacterial survival rate test results
[0028] It can be seen from the above test results that the number of viable bacteria in the microcapsules of the Akkermansia tablets prepared by the method of Example 3 reached 1.57x10~7 CFU / g after 4 weeks, which is higher than the minimum sales standard of 10~7 CFU / g for probiotic preparations set by the International Dairy Federation. Therefore, the Akkermansia tablets of the present invention, as an important way to ensure the activity of Akkermansia muciniphila, can significantly increase the effect of the drug and maintain the stability of the gastrointestinal flora of patients.
[0029] In actual use, the drug effect of the drug of the present invention is more lasting, which helps to reduce the frequency of drug intake and reduce the occurrence of adverse drug reactions.
[0030] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Any technician familiar with the profession can make some changes or modifications to the technical contents disclosed above without departing from the scope of the technical solution of the present invention to obtain equivalent embodiments of equivalent changes. However, any simple modification, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention should be included in the scope of protection of the claims of the present invention.
Claims
1. A hypoglycemic Akkermansia tablet, characterized in that: The Akkermansia tablets are obtained by embedding the symbiotic anaerobic bacteria of the human body into a microcapsule preform to obtain a drug mass, which is then compressed into tablets, wherein: The raw materials for preparing the microcapsule preform include, by weight: 20-25 parts of sodium alginate, 6-10 parts of pectin, 10-18 parts of chitosan and 8-13 parts of sugar-free xylitol; The raw materials for preparing the human body symbiotic anaerobic bacterial group include, by weight: 60-80 parts of Akkermansia muciniphila, 45-60 parts of Lactobacillus and 30-40 parts of Bifidobacterium.
2. The Akkermansia tablet for reducing blood sugar according to claim 1, characterized in that: The raw materials for preparing the microcapsule preform further include, by weight: 20-35 parts of a dissolving agent and 10-15 parts of a thickening agent.
3. The blood sugar lowering Akkermansia tablet according to claim 2, characterized in that: The dissolving agent is citric acid or tartaric acid.
4. The Akkermansia tablet for reducing blood sugar according to claim 2, characterized in that: The raw materials for preparing the thickener include, by weight: 3-5 parts of soybean peptide powder, 6-9 parts of maltose, 10-15 parts of inactivated edible lactic acid bacteria powder and 8-10 parts of casein hydrolyzed peptide; The preparation process of the thickener is as follows: soybean peptide powder, maltose, inactivated edible lactic acid bacteria powder and casein hydrolyzed peptide in a prescribed amount are mixed, and the thickener is obtained after being stirred evenly.
5. The Akkermansia tablet for reducing blood sugar according to claim 2, characterized in that: The preparation process of the microcapsule preform comprises the following steps: (1) Mixing the formulated amounts of sodium alginate, pectin, chitosan and sugar-free xylitol and heating to dissolve them at 60-85° C. to obtain a mixture; (2) dissolving the mixture in a solvent and stirring uniformly to obtain a solution; (3) Add a thickener to the solution and stir evenly to obtain a microcapsule preform.
6. The Akkermansia tablet for lowering blood sugar according to claim 1, characterized in that: The preparation process of the human symbiotic anaerobic bacterial mass is as follows: after mixing the formulated amounts of Akkermansia muciniphila, Lactobacillus and Bifidobacterium, stirring at low temperature in an environment of -2-6°C, and fully mixing to obtain the human symbiotic anaerobic bacterial mass.
7. The Akkermansia tablet for reducing blood sugar according to any one of claims 1 to 6, characterized in that: The Akkermansia tablet is prepared by the following method: S1. The microcapsule preform is embedded in the outer side of the human symbiotic anaerobic bacteria group by an embedding method to obtain a drug group; S2. The drug mass is compressed into tablets by a tableting process to obtain microcapsules, which are Akkermansia tablets.
8. The Akkermansia tablet for lowering blood sugar according to claim 7, characterized in that: The mass ratio of the microcapsule preform used in the preparation method to the human body symbiotic anaerobic bacteria group is 1.2:1.