CN114522174A - Composition for promoting blood sugar balance of type 2 diabetes patients - Google Patents
Composition for promoting blood sugar balance of type 2 diabetes patients Download PDFInfo
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- CN114522174A CN114522174A CN202210299896.2A CN202210299896A CN114522174A CN 114522174 A CN114522174 A CN 114522174A CN 202210299896 A CN202210299896 A CN 202210299896A CN 114522174 A CN114522174 A CN 114522174A
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
The invention provides a composition for promoting blood sugar balance of type 2 diabetes patients, which consists of D-mannose and gamma-aminobutyric acid; wherein the weight ratio of the D-mannose to the gamma-aminobutyric acid is 1-3: 1-3. The composition can increase the number of islet beta cells, balance blood sugar, and improve insulin resistance of type 2 diabetic patients by the combined use of D-mannose and gamma-aminobutyric acid.
Description
Technical Field
The invention relates to the technical field of compositions for improving pancreatic islet function, and particularly relates to a composition for promoting blood sugar balance of type 2 diabetes patients.
Background
There are two main types of diabetes: type 1 diabetes and type 2 diabetes. Type 1 diabetes is rapidly onset, mainly due to autoimmune causes, and requires long-term injections of insulin. Type 2 diabetes develops slowly and requires proper diet, exercise or drug control to maintain blood glucose at a relatively stable level. In both type 1 and type 2 diabetes, inadequate blood glucose control can lead to macroangiopathy and microvascular disease.
At present, the type 2 diabetes mellitus treatment drugs mainly comprise sulfonylureas, meglitinides, biguanides, glycosides, thiazolidinediones, DPP-4 inhibitors, SGLT-2 inhibitors, insulin and the like. Insulin injections risk hypoglycemia, while other drugs often accompany gastrointestinal reactions such as nausea, vomiting, abdominal distension or liver and kidney toxicity.
Aiming at the side effects of the blood sugar control of the diabetes patients at present, the development of a product which is safe and effective in regulating blood sugar, improving insulin resistance and improving the function of islet beta cells to a certain extent is very necessary. The present invention has been made in view of the above problems.
Disclosure of Invention
In order to solve the above problems, the present invention provides a composition for improving blood sugar balance of type 2 diabetic patients, which mainly uses the combination of D-mannose and gamma-aminobutyric acid to improve blood sugar balance of type 2 diabetic patients and improve insulin resistance.
In order to achieve the above object, the technical solution of the present invention is as follows.
A composition for promoting blood sugar balance of type 2 diabetic comprises D-mannose and gamma-aminobutyric acid; wherein the weight ratio of the D-mannose to the gamma-aminobutyric acid is 1-3: 1-3.
Further, the weight ratio of the D-mannose to the gamma-aminobutyric acid is 3: 1-3.
Further, the composition for promoting blood sugar balance of type 2 diabetes patients can be matched with a traditional Chinese medicine composition to play a synergistic effect, and the traditional Chinese medicine composition comprises 1-2 parts by weight of bitter gourd, 0.5-1 part by weight of mulberry leaf and 0.2-0.5 part by weight of momordica grosvenori.
Furthermore, the traditional Chinese medicine composition further comprises the following components in parts by weight: 0.5-1 part of dogbane leaf.
Furthermore, the traditional Chinese medicine composition also comprises: 1-3 parts of tartary buckwheat and 0.5-1 part of propolis.
Furthermore, the traditional Chinese medicine composition also comprises: cyclocarya paliurus 0.1-0.5 parts and wolfberry fruit 0.5-1 parts.
Furthermore, the D-mannose accounts for 30-70% of the total weight of the composition for promoting the blood sugar balance of the type 2 diabetes mellitus patients and the traditional Chinese medicine composition.
Furthermore, the D-mannose accounts for 30-40% of the total weight of the composition for promoting the blood sugar balance of the type 2 diabetes mellitus patients and the traditional Chinese medicine composition.
Further, the composition for promoting blood sugar balance of the type 2 diabetes patients can be matched with auxiliary materials in the pharmaceutical meaning to be prepared into tablets, granules, powder, paste or capsules.
The invention has the beneficial effects that:
1. the composition regulates immunity through D-mannose, further inhibits the expression of inflammatory factors, improves an islet microenvironment, further inhibits islet beta cell dedifferentiation caused by inflammation, creates a good environmental condition for promoting islet alpha cell transdifferentiation of islet beta cells through gamma-aminobutyric acid, and promotes the proliferation of islet beta cells and improves the functions of beta cells through combined use of the islet beta cells and the islet beta cells. Simultaneously, the combination of the two can inhibit the inflammation of the organism, improve the insulin resistance of the type 2 diabetes patients mainly with insulin resistance and balance the blood sugar.
Diabetes belongs to the category of diabetes in traditional Chinese medicine, and the pathology of diabetes is deficiency of both qi and yin, disease and five internal organs, and spleen and kidney are the key points. The treatment mainly comprises supplementing qi and nourishing yin, promoting the production of body fluid to quench thirst, and clearing away heat and toxic materials. The selected traditional Chinese medicine composition takes the balsam pear as a monarch, and has the effects of tonifying qi and replenishing vital essence, quenching thirst and relieving summer heat, and clearing away heat and toxic materials. The mulberry leaves are used as ministers to clear away the lung-heat and moisten dryness, clear away the liver and improve the eyesight. Fructus momordicae is used together with fructus momordicae for clearing heat, moistening lung, relieving cough and relieving sore throat. The medicines are combined to play the effects of supplementing qi and nourishing yin, promoting the production of body fluid to quench thirst and clearing away heat and toxic materials. The Chinese medicinal composition can cooperate with D-mannose and gamma-aminobutyric acid to realize synergistic interaction, and promote blood sugar balance of type 2 diabetes patients.
3. The composition can be used for improving the function of islet beta cells, regulating blood sugar and improving insulin resistance of type 2 diabetes patients. The composition can be used for preparing food, health product or pharmaceutical preparation.
Drawings
FIG. 1 is a histogram analysis of the number ratio of islet beta cells in each group of mice in an animal experiment. Wherein, control represents a normal control group; t2DM represents the T2DM model control group; t2DM + GABA represents the T2DM + γ -aminobutyric acid group; t2DM + D-Man represents the T2DM + D-mannose group; t2DM + GABA + D-Man represents the group T2DM + gamma-aminobutyric acid + D-mannose.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and do not limit the invention.
All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The experimental methods described in the following examples are all conventional methods unless otherwise specified; the reagents and materials, if not otherwise specified, are commercially available; the raw materials of the traditional Chinese medicine composition are extracts obtained by water extraction or alcohol extraction of Shanxi ang warming biotechnology limited company.
Example 1
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 3 parts of D-mannose and 3 parts of gamma-aminobutyric acid.
Example 2
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 3 parts of D-mannose and 1 part of gamma-aminobutyric acid.
Example 3
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 1 part of D-mannose and 2 parts of gamma-aminobutyric acid.
Example 4
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 2 parts of D-mannose and 3 parts of gamma-aminobutyric acid.
Example 5
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 3 parts of D-mannose and 3 parts of gamma-aminobutyric acid.
The traditional Chinese medicine composition comprises, by weight, 2 parts of bitter gourd powder, 1 part of mulberry leaf powder and 0.5 part of momordica grosvenori powder. The traditional Chinese medicine composition takes the balsam pear as a monarch, and has the effects of tonifying qi and replenishing vital essence, quenching thirst and relieving summer heat, and clearing away heat and toxic materials; the mulberry leaves are used as ministers to clear away the lung-heat and moisten dryness, clear away the liver and improve the eyesight; fructus momordicae is used together with fructus momordicae for clearing heat, moistening lung, relieving cough and relieving sore throat; the medicines are combined to play the effects of supplementing qi and nourishing yin, promoting the production of body fluid to quench thirst and clearing away heat and toxic materials.
The composition for promoting the blood sugar balance of the type 2 diabetes patients can be matched with the traditional Chinese medicine composition to play a synergistic interaction effect.
Example 6
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 3 parts of D-mannose and 1 part of gamma-aminobutyric acid.
The traditional Chinese medicine composition comprises, by weight, 2 parts of bitter gourd powder, 1 part of mulberry leaf powder and 0.5 part of momordica grosvenori powder. The traditional Chinese medicine composition takes the balsam pear as a monarch, and has the effects of tonifying qi and replenishing vital essence, quenching thirst and relieving summer heat, and clearing away heat and toxic materials; the mulberry leaves are used as ministers to clear away the lung-heat and moisten dryness, clear away the liver and improve the eyesight; fructus momordicae is used together to clear heat and moisten lung, relieve cough and relieve sore throat; the medicines are combined to play the effects of supplementing qi and nourishing yin, promoting the production of body fluid to quench thirst and clearing away heat and toxic materials.
The composition for promoting the blood sugar balance of the type 2 diabetes patients can be matched with the traditional Chinese medicine composition to play a synergistic interaction role.
Example 7
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 3 parts of D-mannose and 3 parts of gamma-aminobutyric acid.
The traditional Chinese medicine composition comprises, by weight, 2 parts of bitter gourd powder, 1 part of mulberry leaf powder, 0.5 part of momordica grosvenori powder and 1 part of apocynum venetum leaf powder. The traditional Chinese medicine composition takes the balsam pear as a monarch, and has the effects of tonifying qi and replenishing vital essence, quenching thirst and relieving summer heat, and clearing away heat and toxic materials; the mulberry leaves are used as ministers to disperse wind and heat, clear away the lung-heat and moisten dryness; folium apocyni veneti and fructus momordicae are used as adjuvants to clear heat, promote urination, moisten lung and relieve cough; the medicines are combined to play the effects of supplementing qi and nourishing yin, promoting the production of body fluid to quench thirst and clearing away heat and toxic materials.
The composition for promoting the blood sugar balance of the type 2 diabetes patients can be matched with the traditional Chinese medicine composition to play a synergistic interaction role.
Example 8
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 3 parts of D-mannose and 3 parts of gamma-aminobutyric acid.
The traditional Chinese medicine composition comprises, by weight, 2 parts of bitter gourd powder, 1 part of mulberry leaf powder, 0.5 part of momordica grosvenori powder, 2 parts of tartary buckwheat powder and 1 part of propolis powder. The traditional Chinese medicine composition takes the balsam pear and the tartary buckwheat as monarch drugs, and has the effects of tonifying essence and qi, and clearing away heat and toxic materials; the mulberry leaf and the propolis are used as ministers to clear away the lung-heat and moisten dryness, and supplement qi and nourish yin; fructus momordicae is used together with the traditional Chinese medicine for clearing heat, moistening lung, promoting the production of body fluid and quenching thirst; the medicines are combined to play the effects of supplementing qi and nourishing yin, promoting the production of body fluid to quench thirst and clearing away heat and toxic materials.
The composition for promoting the blood sugar balance of the type 2 diabetes patients can be matched with the traditional Chinese medicine composition to play a synergistic interaction role.
Example 9
A composition for promoting blood sugar balance of type 2 diabetes patients is prepared from the following raw materials in parts by weight: 3 parts of D-mannose and 3 parts of gamma-aminobutyric acid.
The traditional Chinese medicine composition comprises, by weight, 2 parts of bitter gourd powder, 1 part of mulberry leaf powder, 0.5 part of momordica grosvenori powder, 0.2 part of cyclocarya paliurus leaf powder and 1 part of medlar powder. The traditional Chinese medicine composition takes the balsam pear and the medlar as monarch drugs to tonify the vital essence and qi and nourish the liver and kidney; the mulberry leaves are used as ministers to disperse wind and heat, clear away the lung-heat and moisten dryness; fructus momordicae and cyclocarya paliurus leaves are used together to clear heat, expel wind, invigorate spleen and regulate qi; the traditional Chinese medicine composition has the effects of tonifying liver and kidney, nourishing yin, promoting fluid production, clearing heat, dispelling wind, strengthening spleen and regulating qi.
The composition for promoting the blood sugar balance of the type 2 diabetes patients can be matched with the traditional Chinese medicine composition to play a synergistic interaction role.
The composition for promoting blood sugar balance of type 2 diabetes patients described in examples 1 to 4 can be formulated with pharmaceutically acceptable excipients into tablets, granules, powders, pastes, or capsules. The following is a detailed description of the tablet alone, and the preparation method of the tablet of the composition is as follows:
weighing the raw materials and 1 part of resistant dextrin according to the parts by weight, respectively sieving the raw materials with a 100-mesh sieve, uniformly mixing, adding ethanol with the volume concentration of 75 percent accounting for 10 percent of the total weight, granulating, drying at 55 ℃ for 3 hours, sieving with a 14-mesh sieve, grading, adding magnesium stearate with the mass fraction of 0.5 percent, uniformly mixing, and pressing into tablets with the mass fraction of 0.6 g/tablet.
The effects of the compositions for promoting blood glucose balance in type 2 diabetes patients described in examples 1 to 4 are substantially the same, and therefore, the effects will be described only with respect to the composition of example 1. The traditional Chinese medicine compositions of examples 5 to 9 can be matched with the composition for promoting the blood sugar balance of the type 2 diabetes patients to play a synergistic effect, and the effects of examples 5 and 6 are basically the same, so that the synergistic effect is only illustrated by the compositions of examples 5 and 7 to 9.
First, animal experiment
1. Test animal
109 SPF-grade C57/BL6 male mice at 6 weeks of age were randomly divided into 2 groups, 15 normal control groups (control group) (group a), and 94 model groups (group B). Group a mice were fed with normal diet and group B with high fat diet. At the beginning of the experiment, group A was injected intraperitoneally with sterile citrate buffer (pH 4.4) and group B was injected intraperitoneally with streptozotocin STZ (dissolved in sterile citrate buffer pH 4.4).
2. Material
Both high fat diet (H10060) and regular diet (1025) were purchased from beijing hua fukang biology.
3. Establishment of T2DM model mouse
At the beginning of the experiment, mice in group B were subjected to intraperitoneal injection of 120mg/(kg · bw) STZ once, and were continuously fed for 8 weeks, after fasting the mice overnight, blood was collected from the tail, and fasting blood glucose was measured. The model is successfully established if the fasting blood glucose is more than 7.0mmol/L, and 72T 2DM model mice are taken for subsequent experiments.
4. Test method
Randomly dividing the model mice into a T2DM model control group (T2DM group), a T2DM + gamma-aminobutyric acid group (T2DM + GABA group), a T2DM + D-mannose group (T2DM + D-Man group) and a T2DM + gamma-aminobutyric acid + D-mannose group (T2DM + GABA + D-Man group);
t2DM + Chinese medicinal composition group I (T2DM + MIX-I), T2DM + gamma-aminobutyric acid + D-mannose + Chinese medicinal composition group I (T2DM + GABA + D-Man + MIX-I), T2DM + gamma-aminobutyric acid + D-mannose + Chinese medicinal composition group II (T2DM + GABA + D-Man + MIX-II), T2DM + gamma-aminobutyric acid + D-mannose + Chinese medicinal composition group III (T2DM + GABA + D-Man + MIX-III), T2DM + gamma-aminobutyric acid + D-mannose + Chinese medicinal composition group IV (T2DM + GABA + D-Man + MIX-IV);
each group had 8. The traditional Chinese medicine composition I group adopts the traditional Chinese medicine composition of the embodiment 5, and consists of 2 parts of balsam pear powder, 1 part of mulberry leaf powder and 0.5 part of momordica grosvenori powder. The traditional Chinese medicine composition II group adopts the traditional Chinese medicine composition of the embodiment 7, and consists of 2 parts of balsam pear powder, 1 part of mulberry leaf powder, 0.5 part of momordica grosvenori powder and 1 part of apocynum venetum leaf powder. The traditional Chinese medicine composition III group adopts the traditional Chinese medicine composition of the embodiment 8, and consists of 2 parts of balsam pear powder, 1 part of mulberry leaf powder, 0.5 part of momordica grosvenori powder, 2 parts of tartary buckwheat powder and 1 part of propolis powder. The traditional Chinese medicine composition group IV adopts the traditional Chinese medicine composition of the embodiment 9, and consists of 2 parts of balsam pear powder, 1 part of mulberry leaf powder, 0.5 part of momordica grosvenori powder, 0.2 part of cyclocarya paliurus leaf powder and 1 part of medlar powder.
All groups of mice are fed with common feed; meanwhile, the composition of example 5 (3 parts of D-mannose +3 parts of gamma-aminobutyric acid +2 parts of balsam pear powder +1 part of mulberry leaf powder +0.5 part of momordica grosvenori powder), the composition of example 7 (3 parts of D-mannose +3 parts of gamma-aminobutyric acid +2 parts of balsam pear powder +1 part of mulberry leaf powder +0.5 part of momordica grosvenori powder +3 parts of mulberry leaf powder +3 parts of momordica grosvenori powder +2 parts of mulberry leaf powder +3 parts of momordica grosvenori powder +2 parts of momordica grosvenori powder +1 part of mulberry leaf powder +3 parts of momordica grosvenori powder +3 parts of D-mannose +2 parts of momordica grosvenori powder +3 parts of D-mangosteen +3 parts of momordica leaf powder +3 parts of momordica grosvenori powder +3 parts of momordica leaf and 3 parts of momordica leaf powder +5 parts of wild jujube, and 5 parts of wild jujube powder +3 parts of wild jujube powder +5 parts of wild jujube powder +1 part of wild jujube powder, and 5 parts of wild jujube powder, and 4 parts of wild jujube powder, and 4 parts of wild jujube powder, and wild jujube powder of wild jujube powder, and wild jujube powder of wild jujube powder, and wild jujube powder of the group of T2 part of the group of T2 group of the group of T2 group of the group of T2, the group of T2 ) The composition of example 8 (3 parts of D-mannose +3 parts of gamma-aminobutyric acid +2 parts of bitter gourd powder +1 part of mulberry leaf powder +0.5 part of momordica grosvenori powder +2 parts of tartary buckwheat powder +1 part of propolis powder), the composition of example 9 (3 parts of D-mannose +3 parts of gamma-aminobutyric acid +2 parts of bitter gourd powder +1 part of mulberry leaf powder +0.5 part of momordica grosvenori powder +0.2 part of cyclocarya paliurus leaf powder +1 part of medlar powder) 200mg/(kg · bw), the frequency is 1 time/day, and the gastric perfusion components are all dissolved by pure water; mice in the normal control group and the T2DM model control group were gavaged with an equal amount of purified water.
Mice were fed water ad libitum during the trial and were weighed and recorded weekly. After feeding for 4 weeks, after fasting the mice overnight, tail blood was taken and fasting blood glucose was measured.
The fasting blood glucose of the mice was measured by a glucometer and a blood glucose test strip, and the results are shown in table 1.
TABLE 1 fasting plasma glucose changes in mice before and after treatment
Note: andcompared with the T2DM group, the method has the advantages that,*p is less than 0.05; compared with the T2DM + GABA + D-Man group,#p is less than 0.05; compared with the T2DM + GABA + D-Man + MIX-I group,△P＜0.05。
as can be seen from table 1, at the end of the trial, fasting blood glucose levels were reduced in all groups compared to the T2DM model group. Meanwhile, compared with the T2DM + GABA group and the T2DM + D-Man group, the fasting blood glucose level of the T2DM + GABA + D-Man group is obviously reduced, and the statistical difference (P is less than 0.05) is achieved, so that the effect of using the combination of the gamma-aminobutyric acid and the D-mannose is obviously greater than the blood glucose reducing effect of a single component.
Compared with the T2DM + GABA + D-Man and the T2DM + MIX-I groups, the T2DM + GABA + D-Man and MIX-I groups have obviously reduced blood sugar and have statistical difference (P is less than 0.05). Compared with the T2DM + GABA + D-Man + MIX-I group, the T2DM + GABA + D-Man + MIX-II group, the T2DM + GABA + D-Man + MIX-IV group and the T2DM + GABA + D-Man + MIX-IV group have similar blood sugar, and the results show that the traditional Chinese medicine composition of the embodiments 5 to 9 provided by the invention has synergistic effect with GABA and D-Man to reduce blood sugar.
After the experiment, mice in a control group, a T2DM group, a T2DM + GABA group, a T2DM + D-Man group and a T2DM + GABA + D-Man group are killed by a cervical dislocation method, parts of pancreatic tissues are cut, after 4% paraformaldehyde is fixed, ethanol dehydration with gradient concentration is carried out, 30% ethanol is soaked for 1h, 50% ethanol is soaked for 1h, 70% ethanol is soaked for 1h, 85% ethanol is soaked for 1h, 95% ethanol is soaked for 30min (repeated once), and 100% ethanol is soaked for 20min (repeated once). And (3) carrying out transparent step treatment on the dehydrated tissue blocks, wherein the process is as follows: soaking in 50% xylene and 50% ethanol for 30min, and soaking in xylene for 30min (repeating once). After the tissues are subjected to transparent treatment, the tissues begin to be soaked and embedded in wax, 50% xylene and 50% paraffin are soaked for 20-30 min (repeated once) and then sliced, and the thickness is 5 microns.
Changes in the number of islet beta cells in mouse pancreatic tissue were observed by immunofluorescence techniques. Randomly selecting 3 mice per group, slicing pancreas tissues by paraffin, baking for 1h at 60 ℃, dewaxing and rehydrating by xylene and absolute ethyl alcohol, placing in a citrate buffer solution, heating for antigen restoration, removing endogenous enzyme, sealing for 1h at room temperature by 5% BSA, dropwise adding a mouse Insulin monoclonal antibody diluted by 1:400, incubating overnight at 4 ℃ in a wet box, washing for 3 times by PBS (phosphate buffer solution) for 5 minutes each time, then dropwise adding FITC (fluorescein isothiocyanate) labeled by 1:200 for dilution, incubating for 1h at 37 ℃ in a dark place, washing for 3 times by PBS for 5 minutes each time, dropwise adding DAPI dye solution, incubating for 15min, and sealing after washing by PBS. The sections were observed and photographed under a fluorescence microscope, 6 islet tissue sections were selected from each mouse, the total islet cell count and the islet β cell count were counted, and the islet β cell ratio was calculated, with the results shown in fig. 1.
As can be seen from FIG. 1, the pancreatic islet beta cell ratio (T2DM) in pancreatic tissue of mice in the T2DM group was significantly reduced (P < 0.05) compared to the normal control group (control group). The proportion of islet beta cells in pancreatic tissues of mice in the T2DM + GABA group and the T2DM + D-Man group is obviously increased (P is less than 0.05) compared with that of mice in the T2DM model group, and the proportion of islet beta cells in pancreatic tissues of mice in the T2DM + GABA + D-Man group is also obviously increased (P is less than 0.05) compared with that of mice in the T2DM + GABA group and the T2DM + D-Man group, so that the effect of promoting the recovery of the proportion of islet beta cells is obviously enhanced compared with that of a single component when the gamma-aminobutyric acid and the D-mannose are used in a combined mode, and the effect of promoting the recovery of the proportion of islet beta cells by the gamma-aminobutyric acid and the D-mannose is further verified to have a synergistic effect of promoting the recovery of the proportion of islet beta cells.
Second, clinical trial
1. 100 cases of T2DM patients were selected. 100 volunteers were divided into a control group and a treatment group (tablets made in example 1), and 50 groups were used. The general clinical data of the two groups of patients was not statistically significant (P > 0.05) (see Table 2). All patients had signed an informed consent to voluntarily participate in the study.
TABLE 2 comparison of general clinical data of two groups of T2DM patients
2. Inclusion and exclusion criteria
Inclusion criteria were: the diagnosis standard meets the diagnosis of T2MD in Chinese diabetes prevention and treatment guidelines for type 2 diabetes (2020 edition) formulated by the diabetes and urology division of the Chinese medical society; ② the first diagnosis is T2DM and no systematic treatment; ③ age range of 30-65 years; fourthly, IBM is less than 28kg/m2(ii) a Complete clinical case data.
Exclusion criteria: (ii) other types of diabetes; ② gestation and lactation; ③ allergy to the study drug; the existence of serious complications and accompanied serious diseases of heart, lung, liver, kidney, liver and kidney, blood system and immune system.
3. Method of treatment
Both groups of patients were given diabetes health education, diet and exercise advice. Patients in the control group were administered conventional oral metformin hydrochloride tablets (Beijing Jingfeng pharmaceutical group, Inc., standard: 0.25g × 48 tablets, national standard H11021518) at a dose of 0.25 g/time, 3 times per day. The treatment group was given the tablet of example 1, 0.6 g/time, 2 times per day.
3.1 comparison of blood glucose levels in two groups of T2DM patients
Venous blood was drawn before and 3 months after treatment in the two groups, 100g steamed bread meal test was performed, blood was taken at 0min and 120min to test blood glucose (FPG, 2hPG), Fasting Insulin (FINS), glycated hemoglobin (HbA1c), and insulin resistance index (HOMA-IR) was calculated as HOMA-IR ═ fasting blood glucose level (FPG, mmol/L) × fasting insulin level (FINS, mIU/L)/22.5. The above results are shown in Table 3.
TABLE 3 comparison of blood glucose levels in two groups of T2DM patients
Note: compared with the treatment before the treatment,*p is less than 0.05; compared with the control group, the compound of the formula,#P＜0.05。
as can be seen from Table 3, the comparison of the FPG, 2hPG, HbA1c, FINS, HOMA-IR levels of the two groups of patients before treatment did not show any statistical significance (P > 0.05); after 3 months of treatment, the FPG, 2hPG, HbA1c, FINS and HOMA-IR levels of the two groups of patients are all significantly lower than those before treatment, and the FPG, 2hPG, HbA1c, FINS and HOMA-IR levels of the treatment group of patients are significantly reduced than those of the control group, and the difference has statistical significance (P is less than 0.05). The combination of D-mannose and gamma-aminobutyric acid is proved to reduce the blood sugar and glycosylated hemoglobin levels before and after 2 hours of meals, reduce fasting insulin levels and improve insulin resistance of type 2 diabetes patients, and the effect is better than that of single metformin hydrochloride tablet treatment.
3.2 comparison of inflammation-related markers in two groups of T2DM patients
Venous blood was collected before and after 3 months of treatment, and tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), and C-reactive protein (CRP) were detected, as shown in Table 4.
TABLE 4 comparison of inflammation-related indices in two groups of T2DM patients
Note: compared with the treatment before the treatment,*p is less than 0.05; compared with the control group, the compound of the formula,#P＜0.05。
the data in Table 4 show that the indexes of TNF-alpha, IL-6 and CRP of the two groups have no statistical significance (P is more than 0.05) before treatment; after 3 months of treatment, the levels of TNF-alpha, IL-6 and CRP of two groups of patients are reduced compared with the levels before treatment, and the difference has statistical significance (P is less than 0.05), which shows that the combination of D-mannose and gamma-aminobutyric acid can improve the organism inflammation state of the type 2 diabetes patients; compared with the drug control group, the treatment groups have more obvious reduction of TNF-alpha, IL-6 and CRP and have statistical difference (P is less than 0.05).
4. Evaluation of safety
The adverse reactions after the two groups of treatments were compared.
The patients in the control group suffered from nausea 2 cases, vomiting 1 case and rash 1 case, and the incidence rate of adverse reactions was 8.00% (4/50); the patients in the treatment group had 1 case of reduced appetite, and the incidence of adverse reactions was 2.00% (1/50), which is lower than that in the control group. The adverse symptoms of both groups of patients were self-alleviating.
Third, conclusion
The composition for promoting the blood sugar balance of the type 2 diabetes patients can increase the number of islet beta cells, balance insulin secretion, regulate blood sugar and improve insulin resistance of the type 2 diabetes patients by combined use of D-mannose and gamma-aminobutyric acid; and the effect of the combination of the gamma-aminobutyric acid and the D-mannose is obviously larger than that of a single component.
The present invention is not limited to the above preferred embodiments, and any modifications, equivalent substitutions and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (8)
1. A composition for improving blood glucose balance in type 2 diabetic patients, comprising D-mannose and gamma-aminobutyric acid; wherein the weight ratio of the D-mannose to the gamma-aminobutyric acid is 1-3: 1-3.
2. The composition for promoting blood sugar balance of type 2 diabetes patients according to claim 1, wherein the weight ratio of the D-mannose to the gamma-aminobutyric acid is 3: 1-3.
3. The composition for promoting blood sugar balance of type 2 diabetes patients according to claim 1, wherein the composition for promoting blood sugar balance of type 2 diabetes patients can cooperate with a traditional Chinese medicine composition to play a synergistic effect, and the traditional Chinese medicine composition comprises 1-2 parts by weight of balsam pear, 0.5-1 part by weight of mulberry leaf and 0.2-0.5 part by weight of momordica grosvenori.
4. The composition for promoting blood glucose balance of a type 2 diabetic patient according to claim 3, wherein the traditional Chinese medicine composition further comprises, in parts by weight: 0.5-1 part of dogbane leaf.
5. The composition for promoting blood glucose balance of type 2 diabetes mellitus patients according to claim 3, wherein said Chinese medicinal composition further comprises: 1-3 parts of tartary buckwheat and 0.5-1 part of propolis.
6. The composition for promoting blood glucose balance of type 2 diabetes mellitus patients according to claim 3, wherein said Chinese medicinal composition further comprises: cyclocarya paliurus leaves 0.1-0.5 parts and wolfberry fruit 0.5-1 parts.
7. The composition for promoting blood sugar balance of patients with type 2 diabetes according to any one of claims 3-6, wherein the D-mannose accounts for 30-70% of the total weight of the composition for promoting blood sugar balance of patients with type 2 diabetes and the traditional Chinese medicine composition.
8. The composition for promoting blood glucose balance of type 2 diabetes mellitus patients according to claim 7, wherein the D-mannose accounts for 30-40% of the total weight of the composition for promoting blood glucose balance of type 2 diabetes mellitus patients and the traditional Chinese medicine composition.
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| CN102389413A (en) * | 2009-02-23 | 2012-03-28 | 王庆华 | Composition used for treating diabetes mellitus, and application thereof |
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