A composition for maintaining blood glucose balance and use thereof

Abstract

The present application belongs to the technical field of functional food and health food, and particularly relates to a composition for maintaining blood glucose balance and application thereof. The composition for maintaining blood glucose balance comprises the following raw material components in percentage by mass: total phenol extract of Momordica hirta leaf 15% to 20%, 1-deoxynojirimycin 2% to 5%, chromium picolinate 0.1% to 0.3%, prebiotic 20% to 30%, and the balance being auxiliary materials; the prebiotic is in mass ratio of 2:1 to 4:1 of inulin and fructooligosaccharide. The present application adopts the combination of total phenol extract of Momordica hirta leaf, 1-deoxynojirimycin, chromium picolinate and prebiotic, and in particular, the prebiotic is inulin and fructooligosaccharide in a specific ratio, and the components play a synergistic effect of multi-target and multi-pathway, so as to achieve comprehensive and stable regulation of blood glucose and significant improvement of islet function.

Description

Technical Field

[0001] This invention belongs to the field of functional food and health food technology, specifically relating to a composition for maintaining blood sugar balance and its application. Background Technology

[0002] With the continued rise in the global prevalence of diabetes and metabolic syndrome, maintaining blood glucose balance has become a research hotspot in the fields of nutrition and medicine. Currently available blood glucose control products often suffer from problems such as single-ingredient formulations, unclear mechanisms of action, or significant side effects. Traditional diabetes management strategies primarily rely on drug therapy; however, while existing drugs such as metformin and insulin have proven efficacy, they also present challenges such as gastrointestinal discomfort, the risk of hypoglycemia, and poor patient adherence. Therefore, developing natural compositions with multi-target effects, high safety profiles, and good patient adherence has become a current research focus in the field of diabetes treatment.

[0003] In recent years, numerous studies have confirmed the great potential of natural products and their combinations in diabetes management. These natural products exert their hypoglycemic effects through multi-target mechanisms, including inhibiting α-glucosidase activity, improving insulin sensitivity, protecting pancreatic β-cell function, and regulating gut microbiota. However, current research on the compatibility of active ingredients from natural plants still faces challenges, such as a lack of scientific basis for component and ratio information and unclear synergistic mechanisms of action, making it difficult to ensure stable hypoglycemic efficacy and medication safety.

[0004] Therefore, there is a need to develop a compound composition based on the scientific formulation of natural plant active ingredients and to achieve blood glucose homeostasis regulation through multi-pathway synergistic effects. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides a composition for maintaining blood glucose balance and its application. By employing a combination of total phenolic extracts from bitter melon leaves, 1-deoxynojirimycin, chromium pyridinecarboxylate, and prebiotics, particularly using a specific ratio of inulin and fructooligosaccharides as prebiotics, the components exert a synergistic effect across multiple targets and pathways, achieving comprehensive and stable regulation of blood glucose and a significant improvement in pancreatic function.

[0006] To achieve the objectives of this invention, the following technical solution is adopted: The present invention provides a composition for maintaining blood glucose balance, comprising the following raw material components in weight percentage: 15%~20% total phenolic extract of bitter melon leaves, 2%~5% 1-deoxynojirimycin, 0.1%~0.3% chromium pyridinecarboxylate, 20%~30% prebiotics, and the balance being excipients; The prebiotics are inulin and fructooligosaccharides in a mass ratio of 2:1 to 4:1.

[0007] In existing technologies, momordicin and 1-deoxynojirimycin are often used in combination for blood glucose regulation. The combination can effectively inhibit the activity of intestinal α-glucosidase and delay the breakdown and absorption of carbohydrates. However, when the two are used together, due to the low bioavailability of 1-deoxynojirimycin, the dosage often needs to be greatly increased to achieve the expected blood glucose lowering effect. This not only easily causes gastrointestinal adverse reactions such as abdominal distension and diarrhea, but also induces problems such as postprandial hypoglycemia and large fluctuations in blood glucose due to the superposition of drug effects. It is impossible to achieve long-term stable control of postprandial blood glucose peak.

[0008] The composition for maintaining blood glucose balance provided by this invention includes total phenolic extract of bitter melon leaves, 1-deoxynojirimycin, inulin, fructooligosaccharides, and chromium picolinate. These components work synergistically through different mechanisms to achieve stable blood glucose control and improve pancreatic function. Specifically, the total phenolic extract of bitter melon leaves reduces oxidative damage to pancreatic β-cells and, in synergistically with chromium picolinate, strengthens insulin signaling, significantly improving pancreatic function. 1-deoxynojirimycin inhibits α-glucosidase, delaying the breakdown of starch and sucrose into glucose in the intestines; it, together with the total phenolic extract of bitter melon leaves, achieves a dual effect of protecting the pancreas and slowing sugar absorption. Inulin and fructooligosaccharides, compounded in a specific mass ratio, act as prebiotics. While repairing the intestinal flora and preventing chronic inflammation from continuously damaging the pancreas, the prebiotics, in synergistic with the total phenolic extract of bitter melon leaves, maintain the normal secretory rhythm of pancreatic β-cells, further consolidating blood glucose homeostasis regulation. Ultimately, this achieves stable blood glucose control in the initial stage, and subsequently, by strengthening pancreatic function, continuously maintains blood glucose homeostasis.

[0009] Preferably, the mass ratio of inulin to fructooligosaccharides is 3:1.

[0010] Preferably, the excipients include fillers, adhesives, and lubricants.

[0011] More preferably, the filler accounts for 39% to 58% of the mass of the composition for maintaining blood glucose balance.

[0012] More preferably, the adhesive accounts for 2% to 3% of the mass of the composition for maintaining blood glucose balance.

[0013] More preferably, the lubricant accounts for 0.5% to 2% of the mass of the composition for maintaining blood glucose balance.

[0014] More preferably, the filler is at least one of lactose, microcrystalline cellulose, or pregelatinized starch.

[0015] More preferably, the adhesive is at least one of povidone K30, povidone K90, or hydroxypropyl cellulose.

[0016] More preferably, the lubricant is at least one of magnesium stearate, talc, or polyethylene glycol 6000.

[0017] Preferably, the preparation method of the total phenolic extract of bitter melon leaves includes the following steps: alcohol extraction of bitter melon leaves, concentration of the extract, extraction and purification of the concentrated crude extract to obtain the total phenolic extract of bitter melon leaves.

[0018] More preferably, the alcohol extraction solution is an aqueous ethanol solution with a volume concentration of 68%-73%.

[0019] More preferably, the mass-to-volume ratio of the bitter gourd leaf to the alcohol extract solution is 1g:(12~18)mL.

[0020] For example, the bitter gourd leaves can be dried bitter gourd leaf powder obtained by crushing and sieving, and the particle size of the dried bitter gourd leaf powder is 60-80 mesh.

[0021] More preferably, the alcohol extraction temperature is 75~85℃ and the time is 3~5h.

[0022] More preferably, the concentration temperature is 40~50℃ and the vacuum degree is -0.08~-0.1MPa.

[0023] More preferably, the concentration endpoint is 1 / 4 to 1 / 6 of the extract volume.

[0024] More preferably, the solvent for extraction is petroleum ether.

[0025] More preferably, the volume ratio of the extraction solvent to the crude extract is (0.8~1.3):1.

[0026] More preferably, the purification is carried out using D101 macroporous adsorption resin.

[0027] More preferably, the purification includes: mixing the extracted defatted extract with water, loading the sample, eluting with an alcohol solution, collecting the eluent, concentrating, and drying to obtain the total phenolic extract of bitter melon leaves.

[0028] More preferably, the mass-to-volume ratio of the defatted extract to water is 1 g: (8~10) mL.

[0029] More preferably, the sample loading flow rate is 1~4 BV / h. Here, BV refers to the resin bed volume as a reference unit, and 4 BV means 4 times the resin bed volume.

[0030] More preferably, the sample loading process also includes washing with water to remove impurities.

[0031] For example, the amount of water used for washing away impurities is 2-4 BV, and the flow rate for washing away impurities is 2-3 BV / h.

[0032] More preferably, the alcohol solution is an aqueous ethanol solution with a volume concentration of 68%-73%.

[0033] More preferably, the amount of the alcohol solution used is 2-3 BV.

[0034] More preferably, the elution flow rate is 0.5~2 BV / h.

[0035] More preferably, the concentration temperature is 40~50℃ and the vacuum degree is -0.08~-0.1MPa.

[0036] More preferably, the drying temperature is 50~60℃, the vacuum degree is -0.08~-0.1MPa, and the time is 8~12h.

[0037] The present invention also provides a formulation comprising the above-described composition for maintaining blood glucose balance.

[0038] Preferably, the dosage form of the preparation is tablets, pills, granules or capsules.

[0039] The present invention provides a tablet comprising the above-described composition for maintaining blood glucose balance.

[0040] Preferably, the tablets are produced using wet granulation and tableting, dry granulation and tableting, or direct tableting processes.

[0041] The beneficial effects provided by this invention are: The composition for maintaining blood glucose balance provided by this invention includes total phenolic extract of bitter melon leaves and specific prebiotics, which can synergistically maintain the normal secretory rhythm of pancreatic β cells and ensure stable blood glucose regulation. Simultaneously, this invention combines 1-deoxynojirimycin with total phenolic extract of bitter melon leaves to achieve a dual effect of protecting pancreatic function and slowing down glucose absorption, significantly reducing the dosage of 1-deoxynojirimycin. While retaining the original hypoglycemic effect, it reduces related adverse reactions and avoids the risk of large fluctuations in blood glucose. This composition contains total phenolic extract of bitter melon leaves, 1-deoxynojirimycin, inulin, fructooligosaccharides, and chromium picolinate. Through the synergistic mechanism of each component, it jointly regulates glucose metabolism pathways at multiple targets, ultimately achieving the effect of improving pancreatic function and stabilizing blood glucose control, while also significantly improving medication safety. Detailed Implementation

[0042] The present invention will be further described in detail below through specific embodiments, but this is only for the purpose of helping to understand the present invention and enabling those skilled in the art to implement or use the present invention, and does not constitute any limitation on the present invention.

[0043] The following description is based on specific embodiments.

[0044] Example 1 This embodiment provides a composition for maintaining blood glucose balance, comprising the following raw material components in weight percentage: 18% total phenolic extract of bitter melon leaves, 3% 1-deoxynojirimycin, 0.2% chromium picolinate, 19.5% inulin, 6.5% fructooligosaccharides, 47.8% lactose, 3% povidone K30, and 2% magnesium stearate; The preparation method of the total phenolic extract of bitter melon leaves includes the following steps: S1. Weigh the dried bitter gourd leaf powder that has passed through a 70-mesh sieve and place it in a round-bottom flask. Add 70% ethanol aqueous solution at a mass-to-volume ratio (g / mL) of 1:15 and reflux in a water bath at 80℃ for 4 hours to obtain the extract. S2. The obtained extract was directly transferred to a rotary evaporator and concentrated under reduced pressure at 45℃ and -0.09MPa to 1 / 5 of the original volume to obtain a crude extract. S3. Add an equal volume of petroleum ether directly to the obtained crude extract, shake to mix, let stand and separate into layers, discard the upper petroleum ether phase, remove fat-soluble impurities, and obtain a defatted extract. S4. Dissolve the defatted extract in water at a mass-to-volume ratio (g / mL) of 1:9 and load it onto a pretreated D101 macroporous adsorption resin column. Control the loading flow rate at 2 BV / h. Remove impurities with 3 BV of water at a flow rate of 2.5 BV / h. Elute with 2.3 BV of 70% ethanol aqueous solution at a flow rate of 1.0 BV / h and collect the phenol-containing eluent. S5. The phenol-containing eluent is concentrated under reduced pressure at 45℃ and -0.09MPa to 1 / 13 of its original volume, and then dried at 55℃ and -0.09MPa for 10 hours to obtain the total phenol extract of bitter melon leaves.

[0045] This embodiment also provides a tablet, the preparation method of which includes the following steps: Add povidone K30 to water to prepare a 3% (w / v) povidone K30 aqueous solution; The weighed total phenolic extract of bitter melon leaves, 1-deoxynojirimycin, chromium pyridinecarboxylate, inulin, fructooligosaccharides, lactose and magnesium stearate were added to a mixing device and homogenized for 12 minutes. The mixed powder was fed into a fluidized bed and sprayed into a povidone K30 aqueous solution at a spray rate of 20 rpm under air inlet conditions of 60°C to complete spray granulation. The mixture was dried at a constant temperature of 65°C for 16 minutes, passed through a 22-mesh sieve to complete granulation, and finally compressed into 500mg tablets.

[0046] Example 2 This embodiment provides a composition for maintaining blood glucose balance, comprising the following raw material components in weight percentage: 15% total phenolic extract of bitter melon leaves, 2% 1-deoxynojirimycin, 0.1% chromium pyridinecarboxylate, 16% inulin, 4% fructooligosaccharides, 57.9% microcrystalline cellulose, 3% hydroxypropyl cellulose, and 2% talc. The preparation method of the total phenolic extract of bitter melon leaves includes the following steps: S1. Weigh the dried bitter gourd leaf powder that has passed through a 60-mesh sieve and place it in a round-bottom flask. Add 70% ethanol aqueous solution at a mass-to-volume ratio (g / mL) of 1:12 and reflux in a water bath at 75℃ for 5 hours to obtain the extract. S2. The obtained extract was directly transferred to a rotary evaporator and concentrated under reduced pressure at 40℃ and -0.1MPa to 1 / 6 of the original volume to obtain a crude extract. S3. Add 0.8 times the volume of petroleum ether directly to the obtained crude extract, shake to mix, let stand and separate into layers, discard the upper petroleum ether phase, remove fat-soluble impurities, and obtain defatted extract. S4. Dissolve the defatted extract in water at a mass-to-volume ratio (g / mL) of 1:8 and load it onto a pretreated D101 macroporous adsorption resin column. Control the loading flow rate at 1 BV / h. Remove impurities with 2 BV of water at a flow rate of 2 BV / h. Elute with 2 BV of 70% ethanol aqueous solution at a flow rate of 0.5 BV / h and collect the phenol-containing eluent. S5. The phenol-containing eluent is concentrated under reduced pressure at 40℃ and -0.1MPa to 1 / 13 of its original volume, and then dried at 50℃ and -0.08MPa for 12 hours to obtain the total phenol extract of bitter melon leaves.

[0047] This embodiment also provides a tablet, the preparation method of which includes the following steps: Add hydroxypropyl cellulose to water to prepare a 2.5% (w / v) hydroxypropyl cellulose aqueous solution; Weigh out the total phenolic extract of bitter melon leaves, 1-deoxynojirimycin, chromium pyridinecarboxylate, inulin, fructooligosaccharides, microcrystalline cellulose and talc, and put them into a mixing device for homogenization and mixing for 10 min. The mixed powder is then fed into a fluidized bed and sprayed into an aqueous solution of hydroxypropyl cellulose at a spray rate of 17 rpm under air inlet conditions at 55℃ to complete spray granulation. The solution is then dried at a constant temperature of 60℃ for 18 min, granulated by passing it through an 18-mesh sieve, and finally compressed into 500mg tablets.

[0048] Example 3 This embodiment provides a composition for maintaining blood glucose balance, comprising the following raw material components by weight percentage: 20% total phenolic extract of bitter melon leaves, 5% 1-deoxynojirimycin, 0.3% chromium picolinate, 20% inulin, 10% fructooligosaccharides, 39.7% pregelatinized starch, 2.2% povidone K90, and 0.5% polyethylene glycol 6000; The preparation method of the total phenolic extract of bitter melon leaves includes the following steps: S1. Weigh out the dried bitter gourd leaf powder that has passed through an 80-mesh sieve, place it in a round-bottom flask, add 70% ethanol aqueous solution at a mass-to-volume ratio (g / mL) of 1:18, and reflux in a water bath at 85℃ for 3 hours to obtain the extract. S2. The obtained extract was directly transferred to a rotary evaporator and concentrated under reduced pressure at 50℃ and -0.08MPa to 1 / 4 of the original volume to obtain a crude extract. S3. Add 1.3 times the volume of petroleum ether directly to the obtained crude extract, shake to mix, let stand and separate into layers, discard the upper petroleum ether phase, remove fat-soluble impurities, and obtain defatted extract. S4. Dissolve the defatted extract in water at a mass-to-volume ratio (g / mL) of 1:10 and load it onto a pretreated D101 macroporous adsorption resin column. Control the loading flow rate at 4 BV / h. Remove impurities with 4 BV of water at an elution flow rate of 3 BV / h. Elute with 3 BV of 70% ethanol aqueous solution at an elution flow rate of 2.0 BV / h and collect the phenol-containing eluent. S5. The phenol-containing eluent is concentrated to 1 / 13 of its original volume under reduced pressure at 50℃ and -0.08MPa, and then dried at 60℃ and -0.1MPa for 8 hours to obtain the total phenol extract of bitter melon leaves.

[0049] This embodiment also provides a tablet, the preparation method of which includes the following steps: Add povidone K90 to water to prepare a 4% (w / v) povidone K90 aqueous solution; The weighed total phenolic extract of bitter melon leaves, 1-deoxynojirimycin, chromium pyridinecarboxylate, inulin, fructooligosaccharides, pregelatinized starch and polyethylene glycol 6000 were added to a mixing device and homogenized for 15 min. The mixed powder was fed into a fluidized bed and sprayed into a povidone K90 aqueous solution at a spray rate of 25 rpm under air inlet conditions of 65℃ to complete spray granulation. The mixture was dried at a constant temperature of 69℃ for 13 min, passed through a 24-mesh sieve to complete granulation, and finally compressed into 500mg tablets.

[0050] Comparative Example 1 This comparative example provides a composition and tablet thereof for maintaining blood glucose balance, which differs from Example 1 in that: In Example 1 of this invention, the inulin and fructooligosaccharide used were adjusted from 3:1 to 1:1 while keeping the total amount of inulin and fructooligosaccharide unchanged at 26%. The other components and dosages, preparation methods and process conditions are the same as in Example 1 of this invention.

[0051] Comparative Example 2 This comparative example provides a composition and tablet thereof for maintaining blood glucose balance, which differs from Example 1 in that: In Example 1 of this invention, the inulin and fructooligosaccharide used were adjusted from 3:1 to 5:1 while keeping the total amount of inulin and fructooligosaccharide unchanged at 26%. The other components and dosages, preparation methods and process conditions are the same as in Example 1 of this invention.

[0052] Comparative Example 3 This comparative example provides a composition and tablet thereof for maintaining blood glucose balance, which differs from Example 1 in that: The total phenolic extract of bitter melon leaves used in Example 1 of this invention was replaced with an equal amount of momordicin; The other components and dosages, preparation methods and process conditions are the same as in Example 1 of this invention.

[0053] Experimental Example 1 The inclusion criteria for this trial were: non-pregnant adults with fasting venous plasma glucose <7.0 mmol / L, and a 2-hour blood glucose level between 7.8 and 11.1 mmol / L after an oral glucose tolerance test (OGTT), clinically diagnosed with impaired glucose tolerance. Sixty volunteers aged 40-60 years, diagnosed with impaired glucose tolerance by OGTT, without serious underlying diseases, and not using hypoglycemic drugs were selected based on these criteria. They were randomly divided into 6 groups and administered tablets of the compositions prepared in Examples 1-3 and Comparative Examples 1-3, respectively, once daily, one tablet each time, for 30 consecutive days. Fasting insulin and fasting blood glucose levels were monitored throughout the intervention. The increase in HOMA-β pancreatic function index and the decrease in average blood glucose fluctuation were calculated. Gastrointestinal discomfort and hypoglycemia were recorded throughout the intervention. Specific detection methods are as follows: Improvement in HOMA-β pancreatic islet function index: Subjects in each group received the corresponding test sample for 30 consecutive days of intervention. Fasting venous blood was collected before and after the intervention to measure two core indicators: fasting insulin level (μU / mL) and fasting blood glucose (mmol / L). The HOMA-β pancreatic islet function index before and after the intervention was calculated. Finally, the improvement in HOMA-β pancreatic islet function index for each group was statistically analyzed. The calculation formula is as follows: HOMA-β pancreatic function index = 20 × fasting insulin level ÷ (fasting blood glucose - 3.5); HOMA-β pancreatic islet function index improvement (%) = (HOMA-β pancreatic islet function index after intervention - HOMA-β pancreatic islet function index before intervention) ÷ HOMA-β pancreatic islet function index before intervention × 100%; The decrease in average blood glucose fluctuation range: Subjects wore dynamic blood glucose monitoring devices to automatically collect blood glucose values ​​every 15 minutes and continuously record blood glucose data for 24 hours. A set of complete 24-hour blood glucose data was collected before the intervention and 30 days after the intervention. The average blood glucose fluctuation range (MAGE) at the two time points before the intervention and 30 days after the intervention was calculated, and the decrease in average blood glucose fluctuation range was finally statistically analyzed. The mean glycemic range (MAGE) is calculated as follows: The absolute value of the difference between adjacent blood glucose values ​​is calculated. When it is greater than 1 blood glucose unit (e.g., 1 mmol / L), the difference is considered a valid glycemic range. Small fluctuations less than 1 blood glucose unit are filtered out, and the average of all valid glycemic range values ​​is calculated as the mean glycemic range (MAGE). The formula for calculating the decrease in average blood glucose fluctuation range is: Decrease in average blood glucose fluctuation range (%) = (MAGE value before intervention - MAGE value after 30 days of intervention) ÷ MAGE value before intervention × 100%.

[0054] The test results are shown in the table below.

[0055] Table 1 As shown in Table 1, the tablets prepared by compounding the total phenolic extract of bitter melon leaves, 1-deoxynojirimycin, chromium pyridinecarboxylate, and inulin and fructooligosaccharides in a specific mass ratio in Examples 1-3 of the present invention were tested on subjects with impaired glucose tolerance. The results showed that the HOMA-β pancreatic islet function index increased by ≥35%, while the average blood glucose fluctuation decreased by ≥23%. This verifies that the composition and tablets provided by the embodiments of the present invention for maintaining blood glucose balance achieve pancreatic islet function improvement and stable blood glucose control through the synergistic effect of multiple components and multiple targets.

[0056] Comparative Examples 1 and 2 are prebiotics in which the mass ratio of inulin to fructooligosaccharides in Example 1 was adjusted. If the inulin content is too high or too low, there will be a significant decline in the improvement of the HOMA-β pancreatic islet function index and the decrease in the average blood glucose fluctuation. Due to the significant decrease in the repair effect of intestinal flora, the islets are damaged and cannot be stably maintained to maintain the normal secretion rhythm of pancreatic β cells, resulting in large blood glucose fluctuations and a significant decline in the pancreatic islet improvement effect.

[0057] In Comparative Example 3, after replacing the total phenolic extract of bitter melon leaves in Example 1 with momordicin, it was impossible to simultaneously regulate the secretory rhythm of pancreatic β-cells and protect against oxidative damage. The pancreatic cells maintained a high-load working state for a long time, and the original multi-target synergistic repair pathway was interrupted, failing to form a coherent synergistic effect. The defect of unstable blood glucose control became prominent, and the average blood glucose fluctuation decreased from more than 23% to 8%. At the same time, due to the loss of the positive regulatory effect on the pancreatic microenvironment, the proliferation and repair efficiency of pancreatic β-cells decreased significantly, and the improvement of the HOMA-β pancreatic function index decreased from more than 35% to less than 15%. Overall, it was impossible to achieve stable blood glucose control and effective improvement of pancreatic function.

[0058] Examples 1-3 of this invention significantly reduced the required dosage of 1-deoxynojirimycin through multi-target synergy, avoiding the risks of intestinal irritation and hypoglycemia caused by high doses of 1-deoxynojirimycin. The incidence of adverse reactions was much lower than that of comparative examples 1-3, verifying the medication safety advantages of the compound formulation of this invention.

[0059] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A composition for maintaining blood glucose balance, characterized in that, The raw material components include the following percentages by weight: 15%~20% total phenolic extract of bitter melon leaves, 2%~5% 1-deoxynojirimycin, 0.1%~0.3% chromium pyridinecarboxylate, 20%~30% prebiotics, and the remainder being excipients; The prebiotics are inulin and fructooligosaccharides in a mass ratio of 2:1 to 4:

1.

2. The composition for maintaining blood glucose balance as described in claim 1, characterized in that, The preparation method of the total phenolic extract of bitter melon leaves includes the following steps: extracting bitter melon leaves with alcohol, concentrating the extract, extracting and purifying the concentrated crude extract to obtain the total phenolic extract of bitter melon leaves.

3. The composition for maintaining blood glucose balance as described in claim 2, characterized in that, The alcohol extraction solution is an aqueous ethanol solution with a volume concentration of 68%-73%; and / or The mass-to-volume ratio of the bitter melon leaf extract to the alcoholic extract solution is 1 g: (12~18) mL; and / or The alcohol extraction is performed at a temperature of 75-85°C for 3-5 hours; and / or The purification process involved D101 macroporous adsorption resin. and / or The purification process includes: mixing the extracted defatted extract with water, loading the sample, eluting with an alcohol solution, collecting the eluent, concentrating, and drying to obtain the total phenolic extract of bitter melon leaves.

4. The composition for maintaining blood glucose balance as described in claim 3, characterized in that, The mass-to-volume ratio of the defatted extract to water is 1 g: (8~10) mL; and / or The sample loading rate is 1~4 BV / h.

5. The composition for maintaining blood glucose balance as described in claim 1, characterized in that, The auxiliary materials include fillers, adhesives, and lubricants.

6. The composition for maintaining blood glucose balance as described in claim 5, characterized in that, The filler comprises 39% to 58% of the mass of the composition for maintaining blood glucose balance; The adhesive comprises 2% to 3% of the mass of the composition for maintaining blood glucose balance; The lubricant accounts for 0.5% to 2% of the mass of the composition for maintaining blood glucose balance.

7. The composition for maintaining blood glucose balance as described in claim 5, characterized in that, The filler is at least one of lactose, microcrystalline cellulose or pregelatinized starch; The adhesive is at least one of polyvinylpyrrolidone K30, polyvinylpyrrolidone K90, or hydroxypropyl cellulose.

8. The composition for maintaining blood glucose balance as described in claim 5, characterized in that, The lubricant is at least one of magnesium stearate, talc, or polyethylene glycol 6000.

9. A formulation, characterized in that, Composition comprising any one of claims 1-8 for maintaining blood glucose balance.

10. A tablet, characterized in that, Composition comprising any one of claims 1-8 for maintaining blood glucose balance.

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