Compound active component with auxiliary hypoglycemic effect and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine pharmacy, and relates to a compound active component with an auxiliary hypoglycemic effect and a preparation method thereof. The preparation method comprises the following steps: mixing 4-6 parts by mass of kudzuvine root, 9-11 parts by mass of corn stigma, 5-7 parts by mass of codonopsis pilosula, 11-13 parts by mass of mulberry, 5-7 parts by mass of rhizoma polygonati, 11-13 parts by mass of medlar and 3-5 parts by mass of eucommia male flower, performing water extraction to obtain a water extract, adding 2-4 parts by mass of guava juice and 3-5 parts by mass of inulin into the water extract, and concentrating until the relative density is 1.10 at the temperature of 20 DEG C to obtain concentrated liquid medicine; and extracting the concentrated liquid medicine for multiple times by using isopyknic ethyl acetate, collecting an ethyl acetate phase, and drying to obtain the compound active component. The compound active component disclosed by the invention has the effects of inhibiting the activity of alpha-glucosidase, alpha-amylase and sucrase and improving sugar tolerance, and can be applied to preparation of medicines for preventing and treating diabetes mellitus.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and relates to a pharmaceutical active component extracted from traditional Chinese medicine, in particular to a compound active component with the effect of assisting in reducing blood sugar and a preparation method thereof. BACKGROUND

[0002] Diabetes is a chronic metabolic disorder characterized by high blood sugar and accompanied by various complications. There are four common types: type I diabetes, type II diabetes, special type diabetes, and gestational diabetes. Type II diabetes is the main type of diabetes, accounting for more than 95% of the total number of diabetes.

[0003] Currently, diabetes has become another important chronic disease that seriously endangers people's health after cardiovascular and cerebrovascular diseases and tumors. Persistent high blood sugar can cause chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves, which seriously affects the quality of life and life expectancy of patients, and brings great medical and economic burden to patients and society.

[0004] Modern research shows that alpha-glucosidase inhibitors can reduce the hydrolysis rate of dietary carbohydrates, thereby reducing blood sugar levels in the human body. Alpha-glucosidase inhibitors are a class of oral hypoglycemic drugs widely used in clinical practice. Their mechanism of action is not dependent on insulin, but by delaying the absorption of carbohydrates to reduce blood sugar. Therefore, alpha-glucosidase inhibitors are safe and have no risk of hypoglycemia, and are particularly suitable for the eastern diabetic population whose diet is heavy in carbohydrates.

[0005] Current alpha-glucosidase inhibitors mainly include acarbose, miglitol, and voglibose, but they may cause gastrointestinal distension, leading to abdominal distension, diarrhea, abdominal pain, and other side effects in clinical use.

[0006] Polysaccharides, saponins, alkaloids, flavonoids, and polypeptides in traditional Chinese medicine have been found to have good alpha-glucosidase inhibitory activity. These alpha-glucosidase inhibitors derived from natural substances have become an important resource for the treatment of type II diabetes.

[0007] For example, medicinal and edible traditional Chinese medicines including Pueraria lobata, mulberry, polygonatum, and medlar, or various compound prescriptions containing them, have been proven to have the effect of assisting in reducing blood sugar. However, compared with alpha-glucosidase inhibitors, their effect of assisting in reducing blood sugar is not very significant, and they do not achieve the effect of inhibiting alpha-glucosidase activity and reducing blood sugar activity. SUMMARY

[0008] The present application aims to further improve the auxiliary hypoglycemic effect, and carries out component separation and activity evaluation screening on the existing traditional prescription to provide a compound active component with auxiliary hypoglycemic effect and a preparation method thereof.

[0009] The compound active component with auxiliary hypoglycemic effect of the present application is obtained by mixing 4-6 parts of pueraria, 9-11 parts of corn silk, 5-7 parts of radix codonopsis, 11-13 parts of mulberry, 5-7 parts of polygonatum, 11-13 parts of medlar, 3-5 parts of eucommia male flower, adding 2-4 parts of psidium guajava juice and 3-5 parts of chrysanthemum powder, and then extracting with water to obtain water extract, concentrating to 1.10 of relative density at 20 DEG C to obtain concentrated liquid, and extracting the concentrated liquid with ethyl acetate to obtain the compound active component.

[0010] Further, the preparation raw materials of the compound active component of the present application preferably include the following components in the following proportions: 5 parts of pueraria, 10 parts of corn silk, 6 parts of radix codonopsis, 12 parts of mulberry, 6 parts of polygonatum, 12 parts of medlar, 4 parts of eucommia male flower, 3 parts of psidium guajava juice and 4 parts of chrysanthemum powder.

[0011] The present application also provides a specific preparation method of the compound active component with auxiliary hypoglycemic effect, which includes the following steps:

[0012] 1) mixing the pueraria, corn silk, radix codonopsis, mulberry, polygonatum, medlar and eucommia male flower in the proportions, immersing in 8 times of water, heating to boiling, and then slowly boiling for 2 hours, filtering to obtain the first decocting liquid, adding 6 times of water to the residue, heating to boiling, and then slowly boiling for 1.5 hours, and filtering to obtain the second decocting liquid;

[0013] 2) combining the two decocting liquids, adding the psidium guajava juice and chrysanthemum powder in the proportions, mixing uniformly, and concentrating to 1.10 of relative density at 20 DEG C to obtain the concentrated liquid;

[0014] 3) extracting the concentrated liquid with ethyl acetate in a volume ratio of 1:1 for 3 times, combining the ethyl acetate extracts, recovering the ethyl acetate under reduced pressure, and then concentrating and drying to obtain the compound active component.

[0015] The compound active component with auxiliary hypoglycemic effect of the present application mainly contains a plurality of active components such as hyperoside, isoquercitrin, scopoletin, daidzein, quercetin, rutin and formononetin.

[0016] Pharmacodynamic evaluation proves that the compound active component with auxiliary hypoglycemic effect of the present application has inhibitory effect on the activities of alpha-glucosidase, alpha-amylase and sucrase, and can improve the glucose tolerance of normal mice and significantly reduce the blood glucose value of mice after starch and sucrose loading.

[0017] Further, the compound active ingredient with auxiliary hypoglycemic efficacy of the present application can also be mixed or embedded with a pharmaceutically acceptable carrier to prepare various oral preparations of pharmaceutical compositions containing a therapeutically effective amount of the compound active ingredient, including but not limited to tablets, capsules, soft capsules, granules, oral liquids or suspensions, etc.

[0018] The carrier can include but is not limited to various fillers / embedding agents such as lactose, sucrose, starch and its derivatives, microcrystalline cellulose, sugar alcohols (such as sorbitol, mannitol), cyclodextrin and its derivatives, etc.; various polymer carriers such as polyethylene glycol, polyvinylpyrrolidone, hydroxypropyl methyl cellulose, gelatin, etc.; various surfactants such as polysorbate, poloxamer, phospholipids, etc.

[0019] Further, one or more of the following functional excipients can also be included in the carrier, including but not limited to: lubricants such as magnesium stearate, talc, colloidal silicon dioxide, etc.; wetting / adhesive agents such as hydroxypropyl cellulose, starch paste, polyvinyl alcohol, etc.; flavoring / masking agents such as steviol glycoside, peppermint oil, ethyl cellulose, etc.; stabilizers such as antioxidants (ascorbic acid, tocopherol), pH regulators (citrate, phosphate), etc.; preservatives such as sodium benzoate, parabens, etc.

[0020] The pharmaceutical composition of the present application can be used as a clinical drug for the prevention and treatment of diabetes.

[0021] The present application uses homologous Chinese medicines such as pueraria, corn silk, radix codonopsis, mulberry, rhizoma polygonati, medlar, eucommia male flower, psidium juice and chrysanthemum powder as raw materials, and obtains a compound active ingredient by water extraction and ethyl acetate extraction. Pharmacodynamic evaluation proves that it can improve the glucose tolerance of normal mice and significantly reduce the blood glucose value of mice after starch and sucrose loading, and is used for preparing a medicine for preventing and treating diabetes, which has the following obvious advantages:

[0022] 1) The compound active ingredient with auxiliary hypoglycemic efficacy prepared by the present application uses homologous Chinese medicines as raw materials, which has high safety and can make up for the defects of side effects of currently used clinical drugs.

[0023] 2) The compound active ingredient with auxiliary hypoglycemic efficacy prepared by the present application is rich in main effective components in 8 kinds of medicinal materials such as pueraria, corn silk, radix codonopsis, mulberry and rhizoma polygonati, and the effect of improving the glucose tolerance of normal mice and reducing the blood glucose value of mice after starch and sucrose loading is obviously better than that of the compound water extract preparation. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 is the FT and FH intervention blood glucose change curve after starch loading in mice.

[0025] Figure 2is the blood glucose change curve of the mouse after the intervention of FT and FH. DETAILED DESCRIPTION

[0026] The specific embodiments of the present application are described in further detail below in conjunction with the accompanying drawings and examples. The following examples are only used to more clearly illustrate the technical solutions of the present application, so that those skilled in the art can well understand and utilize the present application, and are not intended to limit the protection scope of the present application.

[0027] The experimental methods, production processes, instruments and equipment involved in the embodiments of the present application are all conventional names in the art, and are very clear and explicit in the relevant application fields. Those skilled in the art can understand the conventional process steps and apply the corresponding equipment according to the name, and implement it under the conventional conditions or the conditions recommended by the manufacturer.

[0028] The various raw materials or reagents used in the embodiments and comparative examples of the present application are not particularly limited in origin, and are all conventional products that can be obtained by commercial purchase. They can also be prepared according to conventional methods well known to those skilled in the art. EMBODIMENT

[0029] EMBODIMENT 1

[0030] 5 kg of radix puerariae, 10 kg of corn stigma, 6 kg of radix codonopsis, 12 kg of mulberry, 6 kg of polygonatum, 12 kg of medlar, and 4 kg of eucommia male flowers were mixed evenly, 8 times the mass of water was added to soak them thoroughly, and then heated to boiling. After that, the heat was turned to low and the mixture was boiled for 2 hours. The first decoction was obtained by filtration. 6 times the mass of water was added to the residue, heated to boiling, and then boiled for 1.5 hours on low heat. The second decoction was obtained by filtration.

[0031] The two decoctions were combined, 3 kg of psidium guajava juice and 4 kg of chrysanthemum powder were added and mixed evenly, and then concentrated to a relative density of 1.10 at 20℃ to obtain the concentrated medicinal liquid.

[0032] The concentrated medicinal liquid was extracted with an equal volume of ethyl acetate for 3 times, and the combined ethyl acetate extract was concentrated under reduced pressure at 60℃ to recover the ethyl acetate. Then, the compound active component was prepared by drying, which was marked as FH.

[0033] COMPARATIVE EXAMPLE 1

[0034] The concentrated medicinal liquid prepared in Example 1 was further concentrated and dried under reduced pressure to prepare the compound water extract, which was marked as FT.

[0035] EMBODIMENT 2

[0036] Take 4 kg of Gegen, 11 kg of corn silk, 7 kg of Dangshen, 13 kg of mulberry, 5 kg of Huangjing, 11 kg of Gouqizi, 3 kg of Duzhongyanghua mixed evenly, add 8 times the mass of water to soak fully, then heat to boiling, turn to simmer and cook for 2 h, filter to obtain the first decocting liquid. Add 6 times the mass of water to the filter residue, heat to boiling, turn to simmer and cook for 1.5 h, filter to obtain the second decocting liquid.

[0037] Combine the two decocting liquids, then add 2 kg of Psidium guajava juice and 3 kg of chrysanthemum powder, mix evenly, and concentrate to a relative density of 1.10 at 20℃ to obtain concentrated medicinal liquid.

[0038] Take the concentrated medicinal liquid, extract with an equal volume of ethyl acetate for 3 times, collect and concentrate the ethyl acetate extract at 60℃ under reduced pressure to recover ethyl acetate, and then dry to prepare the compound active component.

[0039] Example 3

[0040] Take 6 kg of Gegen, 9 kg of corn silk, 5 kg of Dangshen, 11 kg of mulberry, 7 kg of Huangjing, 13 kg of Gouqizi, and 5 kg of Duzhongyanghua, mix evenly, add 8 times the mass of water to soak fully, then heat to boiling, turn to simmer and cook for 2 h, filter to obtain the first decocting liquid. Add 6 times the mass of water to the filter residue, heat to boiling, turn to simmer and cook for 1.5 h, filter to obtain the second decocting liquid.

[0041] Combine the two decocting liquids, then add 4 kg of Psidium guajava juice and 5 kg of chrysanthemum powder, mix evenly, and concentrate to a relative density of 1.10 at 20℃ to obtain concentrated medicinal liquid.

[0042] Take the concentrated medicinal liquid, extract with an equal volume of ethyl acetate for 3 times, collect and concentrate the ethyl acetate extract at 60℃ under reduced pressure to recover ethyl acetate, and then dry to prepare the compound active component.

[0043] Example 4

[0044] Prepare sample solutions with concentrations of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 and 1.0 mg / mL respectively from the compound active component FH prepared in Example 1 and the compound water extract FT prepared in Comparative Example 1, and use them to determine the inhibitory effect of the compound active component and the compound water extract on α-glucosidase.

[0045] In 96-well plates, 25 μL of 0.1M PBS solution, 25 μL of 1U / mL α-glucosidase solution, 25 μL of sample solution with different concentrations were added respectively, shaken and mixed, and incubated at 37°C for 15 min. After incubation, 80 μL of 3mM pNPG solution was added, and incubated at 37°C for another 15 min. The reaction was terminated by adding 80 μL of 0.1M Na2CO3 solution, and the absorbance value of the sample at 405 nm wavelength (A3) was determined by a microplate reader.

[0046] 25 μL of 0.1M PBS solution was used as sample blank control (A2) instead of α-glucosidase solution; 25 μL of 0.1M PBS solution was used as α-glucosidase complete reaction control (A1) instead of sample solution; and 0.1M PBS solution was used as blank control (A0) without adding sample and α-glucosidase solution.

[0047] The experiment was repeated 3 times, and the inhibition rate of different concentrations of samples was calculated according to the formula α-glucosidase inhibition rate = 1 - (A3-A2) / (A1-A0) x 100%.

[0048] Acarbose was used as a positive control, and the same method was used for determination and calculation of the inhibition rate.

[0049] The inhibition rates of FT and FH on α-glucosidase activity are shown in Table 1.

[0050]

[0051] Table 1 shows that both FT and FH have inhibitory effect on the activity of α-glucosidase, and have dose-dependent effect in the concentration range of 0.1-1.0 mg / mL. Compared with FT, the inhibitory activity of FH on α-glucosidase is significantly better than that of FT.

[0052] Example 5

[0053] The sample solution with a concentration of 0.2, 0.4, 0.6, 0.8, 1.0, 1.2, 1.4, 1.6, 1.8, 2.0 mg / mL was prepared respectively for the compound active ingredient FH prepared in Example 1 and the compound water extract FT prepared in Comparative Example 1, which were used to determine the inhibitory effect of the compound active ingredient and the compound water extract on α-amylase and sucrase.

[0054] 200 μL of the sample solution with the above series of concentrations was taken, mixed with 100 μL of 2U / mL α-amylase, and incubated at 37°C for 20 min. After incubation, 100 μL of 1% starch solution was added, and incubated at 37°C for another 15 min. 100 μL of DNS was added, heated at 100°C for 5 min, then cooled, and added to a 96-well plate. The absorbance value of the sample at 540 nm wavelength (A3) was determined by a microplate reader.

[0055] 100 μL of 0.1M PBS solution instead of the α-amylase solution as a sample blank control (A2); 200 μL of 0.1M PBS solution instead of the sample solution as a complete reaction control of the α-amylase (A1); and 0.1M PBS solution as a blank control without the sample and the α-amylase solution (A0).

[0056] The experiment was repeated three times, and the inhibition rate of the sample at different concentrations was calculated according to the formula: α-amylase inhibition rate = 1 - (A3 - A2) / (A1 - A0) x 100%.

[0057] The same method was used to determine and calculate the inhibition rate with acarbose as a positive control.

[0058] The inhibition rates of FT and FH on the activity of α-amylase are shown in Table 2.

[0059]

[0060] Table 2 shows that FT and FH have an inhibitory effect on the activity of α-amylase, and have a dose-dependent effect in the concentration range of 0.2-2.0 mg / mL. Compared with FT, the inhibitory activity of FH on α-amylase is better than that of FT, indicating that FH is the active component of FT.

[0061] 200 μL of the sample solution at the above series of concentrations was mixed with 100 μL of 2U / mL sucrose solution and shaken, and incubated at 37°C for 10 min. After the incubation was completed, 100 μL of 60 mM sucrose solution was added, and incubated at 37°C for another 30 min. Then, 200 μL of DNS was added, heated at 100°C for 5 min, cooled, and added to a 96-well plate. The absorbance value of the sample at 540 nm wavelength (A3) was determined by an enzyme marker.

[0062] 100 μL of 0.1M PBS solution instead of the sucrose solution as a sample blank control (A2); 200 μL of 0.1M PBS solution instead of the sample solution as a complete reaction control of the sucrose (A1); and 0.1M PBS solution as a blank control without the sample and the sucrose solution (A0).

[0063] The experiment was repeated three times, and the inhibition rate of the sample at different concentrations was calculated according to the formula: sucrose inhibition rate = 1 - (A3 - A2) / (A1 - A0) x 100%.

[0064] The same method was used to determine and calculate the inhibition rate with acarbose as a positive control.

[0065] The inhibition rates of FT and FH on the activity of α-amylase are shown in Table 3.

[0066]

[0067] Table 3 shows that both FT and FH have inhibitory effect on the activity of sucrase, and have dose correlation in the concentration range of 0.2-2.0 mg / mL. Compared with FT, the inhibitory activity of FH on sucrase is better than that of FT, indicating that FH is the active component of FT.

[0068] Example 6

[0069] The compound active component FH prepared in Example 1 and the compound water extract FT prepared in Comparative Example 1 were used as test samples, and the reducing effect on blood glucose value of mice after starch and sucrose loading was evaluated.

[0070] Sixty-four SPF male 8-week-old C57 / BL6J mice weighing 22-24 g were selected for the test, purchased from Vintone Lvhe Experimental Animal (Beijing) Technology Co., Ltd., Animal Production License No. SCXK (Jing) 2021-0006. The mice were fed for 1 week before the experiment, and the animal experiment ethics complied with the 3R principle.

[0071] The test mice were randomly divided into 8 groups, including a blank control group, a positive control group, FT high, medium and low dose groups and FH high, medium and low dose groups, 8 mice in each group.

[0072] After the mice were adaptively fed for 1 week, the animals in each group were fasted for 14-16 h, and the fasting blood glucose was measured, i.e. the blood glucose value before starch or sucrose administration (0 h).

[0073] The positive control group was given acarbose 30 mg / kg (dissolved in CMCNa); the high, medium and low dose groups of FT and FH were respectively given 1946 mg / kg, 973 mg / kg and 486.5 mg / kg of the compound water extract FT prepared in Comparative Example 1 and the compound active component FH prepared in Example 1 (dissolved in CMCNa), and the blank control group was given the same volume of solvent CMCNa.

[0074] After 15-20 min of administration of the test samples, each group was orally administered 1.25 g / kg starch solution or 3 g / kg sucrose solution, and the blood glucose values of the mice in each group at 15, 30, 60, 90 and 120 min after administration of starch or sucrose were determined by blood glucose meter through tail blood sampling.

[0075] Table 4 and Table 5 respectively record the blood glucose value data of each group at different times after administration of starch or sucrose.

[0076]

[0077] Compared with the blank control group, *** indicates p <0.001; under the same administration dose, compared with the FT group,## express p <0.01.

[0078]

[0079] Compared with the blank control group, *** express p <0.001; at the same dosage, compared with the FT group, # express p <0.05, ## express p <0.01, ### express p <0.001.

[0080] Based on Tables 4 and 5, draw... Figure 1 and Figure 2 The graph shows the relationship between blood glucose levels and measurement time, and the area under the blood glucose curve (AUC) from 0 to 120 minutes is calculated.

[0081] According to Table 4 and Figure 1 The results showed that: 1) After intervention with FT and FH in starch-loaded mice, compared with the blank control group, all dose groups of FT and FH could reduce blood glucose levels at 15 min and 30 min after starch loading, as well as AUC values ​​from 0 to 120 min, with significant differences and dose dependence, indicating that both FT and FH have the effect of inhibiting starch absorption and blood glucose elevation; 2) Compared with the high- and medium-dose FT groups (the high-dose FT group had a blood glucose peak reduction rate of 18.07% at 15 min after meal and a AUC value reduction rate of 19.57% from 0 to 120 min), the high- and medium-dose HT groups (the high-dose HT group had a blood glucose peak reduction rate of 27.47% at 15 min after meal and a AUC value reduction rate of 24.37% from 0 to 120 min) had a stronger effect in inhibiting starch absorption and lowering blood glucose, with significant differences, proving that FH is the main active component of FT. This result is consistent with the results of in vitro inhibition of glycosidase activity.

[0082] According to Table 5 and Figure 2It can be seen that 1) after FT and FH intervention in sucrose loading mice, compared with the blank control group, each dose group of FT and FH can reduce the blood glucose value of sucrose loading mice (blood glucose 15 min and 30 min after meal and 0-120 min AUC value), which has significant difference and dose-dependent, which shows that FT and FH can inhibit sucrose absorption and blood glucose rise; 2) compared with each dose group of FT (the blood glucose peak reduction rate of FT high dose group 15 min after meal is 17.99%, and the 0-120 min AUC value reduction rate is 13.63%), each dose group of FH (the blood glucose peak reduction rate of FH high dose group 15 min after meal is 27.34%, and the 0-120 min AUC value reduction rate is 21.63%) has better inhibition of sucrose absorption and blood glucose reduction, and has significant difference, which proves that FH is the main active component of FT for inhibiting sucrose absorption, and the result is consistent with the result of inhibiting glycosidase activity in vitro.

[0083] The above experimental results prove that the compound active component with the auxiliary blood glucose lowering effect of the present application has the effect of inhibiting the activities of alpha-glucosidase, alpha-amylase and sucrase, and can significantly reduce the blood glucose value of mice after starch and sucrose loading, which shows that the compound active component has the auxiliary blood glucose lowering effect.

[0084] The above embodiments of the present application do not describe all the details, and the present application is not limited to the above described embodiments. Various changes, modifications, replacements and variations of the embodiments made by those skilled in the art without departing from the principles and purposes of the present application shall be included in the protection scope of the present application.

Claims

1. A compound active ingredient with auxiliary hypoglycemic efficacy, which is prepared by mixing Puerariae radix 4-6 parts by mass, Zizaniae fructus 9-11 parts by mass, Codonopsis 5-7 parts by mass, Morus alba 11-13 parts by mass, Polygonati rhizoma 5-7 parts by mass, Lycii fructus 11-13 parts by mass, Eucommiae flores 3-5 parts by mass with water to obtain a water extract, adding Psidium guajava juice 2-4 parts by mass and chrysanthemum powder 3-5 parts by mass, concentrating to a relative density of 1.10 at 20℃ to obtain concentrated medicinal liquid, and extracting the concentrated medicinal liquid with ethyl acetate multiple times to obtain the compound active ingredient.

2. The complex active ingredient with auxiliary hypoglycemic efficacy according to claim 1, characterized in that The compound active ingredient is prepared from the following components in the indicated parts by mass: Puerariae radix 5 parts by mass, Zizaniae fructus 10 parts by mass, Codonopsis 6 parts by mass, Morus alba 12 parts by mass, Polygonati rhizoma 6 parts by mass, Lycii fructus 12 parts by mass, Eucommiae flores 4 parts by mass, Psidium guajava juice 3 parts by mass, and chrysanthemum powder 4 parts by mass.

3. The method for preparing the compound active ingredient with auxiliary hypoglycemic efficacy according to claim 1, which comprises: 1) mixing the Puerariae radix, Zizaniae fructus, Codonopsis, Morus alba, Polygonati rhizoma, Lycii fructus, and Eucommiae flores in the indicated parts by mass, adding 8 times the mass of water, heating to boiling, and then gently boiling for 2 hours, filtering to obtain the first decoction, adding 6 times the mass of water to the residue, heating to boiling, and then gently boiling for 1.5 hours, and filtering to obtain the second decoction; 2) combining the two decoctions, adding the Psidium guajava juice and chrysanthemum powder in the indicated parts by mass, mixing well, and concentrating to a relative density of 1.10 at 20℃ to obtain concentrated medicinal liquid; 3) extracting the concentrated medicinal liquid with ethyl acetate 3 times at a volume ratio of 1:1, combining the ethyl acetate extracts, recovering the ethyl acetate under reduced pressure, and concentrating and drying to obtain the compound active ingredient.

4. The use of the compound active ingredient with auxiliary hypoglycemic efficacy according to claim 1 in the preparation of a medicament for preventing or treating diabetes.

5. The use according to claim 4, wherein the compound active ingredient prevents or treats diabetes by inhibiting the activities of α-glucosidase, α-amylase, and sucrase to improve glucose tolerance.

6. A medicament with auxiliary hypoglycemic efficacy, which is prepared by mixing the compound active ingredient according to claim 1 with a pharmaceutically acceptable carrier to obtain an oral preparation containing a therapeutically effective amount of the compound active ingredient.

7. The medicament according to claim 6, characterized in that The oral preparation includes tablets, capsules, soft capsules, granules, oral liquids, or suspensions.

8. The medicament according to claim 6, characterized by The carrier includes fillers / embedding agents, such as lactose, sucrose, starch and its derivatives, microcrystalline cellulose, sugar alcohols, cyclodextrin and its derivatives; polymer carriers, such as polyethylene glycol, polyvinylpyrrolidone, hydroxypropyl methylcellulose, gelatin; surfactants, such as polysorbate, poloxamer, phospholipids.

9. The medicament according to claim 8, characterized in that The carrier also includes one or more of functional excipients, such as lubricants, wetting / adhesive agents, flavoring / masking agents, stabilizers, and preservatives.

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