Composition of fenugreek, inula flower and extracts of fenugreek and inula flower, and medical application of composition for preventing and treating metabolic syndrome, resisting islet injury, promoting gastrointestinal function and like

Abstract

The invention provides a pharmaceutical composition for preventing and treating metabolic syndrome, resisting islet injury and promoting gastrointestinal function. The pharmaceutical composition is an oral preparation prepared from traditional Chinese medicinal raw materials or raw material extracts according to the following weight ratio. The raw material composition comprises the following medicinal materials and decoction pieces in parts by weight: 6-60 parts of fenugreek and 6-60 parts of inula flower. The traditional Chinese medicine composition comprises the following raw material extracts in parts by weight: 1-20 parts of fenugreek extract and 1-25 parts of inula flower extract. The pharmaceutical composition disclosed by the invention can effectively reduce blood sugar, triglyceride and cholesterol, improve insulin tolerance and hyperinsulinemia, improve glucose tolerance, relieve pancreas islet injury and promote gastrointestinal motility. The composition is good in safety, can be clinically used for preventing and treating the metabolic syndrome and protecting pancreas islet in the early stage, and can also be used for treating gastric paralysis and constipation.

Description

Technical Field

[0001] This invention relates to a method for preparing a composition of fenugreek and its extract, and Inula japonica and its extract, as well as its medicinal uses for the prevention and treatment of metabolic syndrome, pancreatic islet damage, and the promotion of gastrointestinal function. Background Technology

[0002] With the rapid development of my country's economy and the continuous improvement of people's living standards, epidemiological studies have found that an increasing number of people simultaneously experience abdominal obesity, elevated blood sugar, elevated triglycerides and LDL cholesterol, elevated blood pressure, insulin resistance, and inflammatory responses, a condition known as metabolic syndrome. These characteristic factors are closely linked, creating a vicious cycle and mutually reinforcing each other, seriously affecting people's health and quality of life, and have become a heavy burden on society and families. A random sampling survey of adults in my country found that the prevalence of metabolic syndrome among obese individuals has exceeded 400 million, including 140 million with diabetes, 330 million with hyperlipidemia, and 245 million with hypertension by 2023, all ranking first in the world. Metabolic syndrome is characterized by high incidence, high disability rate, and high mortality rate, and is closely related to cardiovascular and cerebrovascular diseases. Therefore, it is essential to adopt drug intervention for targeted prevention and treatment of metabolic syndrome, including lowering blood sugar, improving glucose tolerance and lipid metabolism disorders, and controlling hypertension and weight. This is of great significance in breaking the vicious cycle of metabolic syndrome, significantly saving medical expenses, reducing the burden on individuals, families, and the nation, and improving the overall health of the population.

[0003] Fenugreek, a traditional Chinese medicine, is the dried, mature seed of the legume *Trigonella foenum-graecum* L. It possesses warming kidney yang, dispelling cold, and relieving pain, and is mainly used for kidney deficiency and coldness, lower abdominal pain due to cold, inguinal hernia, and beriberi due to cold and dampness. Fenugreek has a long history of use in treating diabetes abroad. Clinical and experimental pharmacological studies have shown that its seed powder, ethanol extract, water extract, and components such as diosgenin and furazolidone, apigenin flavonoids, 4-hydroxyisoleucine, fenugreekine, polysaccharides, and dietary fiber all exhibit good hypoglycemic effects. Simultaneously, clinical studies have found that fenugreek seeds also have certain therapeutic effects on complications of diabetes such as hyperlipidemia and hypercholesterolemia, diabetic nephropathy, diabetic retinopathy, and diabetic nerve damage. Inula japonica, another traditional Chinese medicine, is the capitulum of the Asteraceae plant *Inula britannica* L. subsp. japonica. It has a bitter, pungent, salty, and slightly warm taste, and enters the stomach and large intestine meridians. Its main functions and indications are to eliminate phlegm, promote diuresis, regulate qi, and stop vomiting. Our research group previously discovered for the first time that the aqueous extract of this product has good hypoglycemic activity in diabetic animals, and a patent for this invention has been granted. Summary of the Invention

[0004] The purpose of this invention is to provide a composition of fenugreek and inula japonica, and a composition of fenugreek extract and inula japonica extract, for the prevention and treatment of metabolic syndrome, protecting the morphology and function of pancreatic islets, reducing pancreatic islet damage, and promoting gastrointestinal motility to enhance gastrointestinal motility and improve constipation symptoms.

[0005] To achieve the above objectives, this patent is characterized by comprising fenugreek or fenugreek extract, Inula japonica or Inula japonica extract, a composition of fenugreek and Inula japonica, or a composition of fenugreek extract and Inula japonica extract. The composition and its preparation method provided in this application adopt the following technical solution:

[0006] Firstly, the traditional Chinese medicine composition comprises the following raw materials (medicinal materials and processed slices) in parts by weight: 6-60 parts of fenugreek and 6-60 parts of inula japonica; further, 10-30 parts of fenugreek and 10-30 parts of inula japonica; more preferably, 10 parts of fenugreek and 12 parts of inula japonica.

[0007] The second aspect is that the traditional Chinese medicine composition comprises the following raw material extracts in parts by weight: 1-20 parts of fenugreek extract and 1-25 parts of Inula japonica extract; further, 1-10 parts of fenugreek extract and 1-10 parts of Inula japonica extract; more preferably, 1-3 parts of fenugreek extract and 1-3 parts of Inula japonica extract; even more preferably, 1 part of fenugreek extract and 1 part of Inula japonica extract.

[0008] Thirdly: the above-mentioned fenugreek extract is characterized in that it is an ethanol extract of fenugreek seeds; further, it is an extract extracted with 30% to 95% ethanol; further, the ethanol concentration is 50% to 70%, and most preferably, the ethanol concentration is 70%. The extraction temperature is 0℃ to 100℃; further, the extraction temperature is 20℃ to 80℃; and more preferably, the temperature range is 50℃ to 70℃.

[0009] Fourth aspect: Inula japonica extract, characterized in that it is an Inula japonica aqueous or water-ethanol extract; further, it is an extract extracted with 0% to 50% ethanol, and even further, the ethanol concentration is 0% to 30%. The extraction temperature is 0℃ to 100℃; further, the extraction temperature is 20℃ to 80℃; a more preferred temperature range is 50℃ to 70℃.

[0010] Fifth aspect: an extract of fenugreek ethanol extract, characterized in that fenugreek or fenugreek ethanol extract is extracted with n-butanol or acetone to prepare n-butanol extract or acetone extract.

[0011] The sixth aspect: the use of combinations of fenugreek and Inula japonica raw materials, and combinations of fenugreek extract and Inula japonica extract for the treatment of metabolic syndrome.

[0012] The seventh aspect: Combinations of fenugreek and Inula japonica raw materials, and combinations of fenugreek extract and Inula japonica extract, are used to protect pancreatic islet morphology and β-cell function, and reduce pancreatic islet damage.

[0013] Eighth aspect: Combinations of fenugreek and Inula japonica raw materials, and combinations of fenugreek extract and Inula japonica extract are used to promote gastrointestinal motility and treat gastroparesis and constipation.

[0014] Compared with the prior art, the beneficial effects of the present invention

[0015] 1. Ancient and modern physicians believe that kidney yang is the yang of the whole body, and the spleen's function of transformation and transportation depends on the warming and steaming effect of kidney yang. Fenugreek enters the kidney meridian, warming kidney yang and nourishing the lower abdomen. Inula japonica promotes qi circulation and water metabolism, enabling the qi transformation of the middle jiao to proceed smoothly, allowing clear yang to rise and turbid qi to descend, thus facilitating the flow of body fluids. The combination of fenugreek and Inula japonica works synergistically to warm yang, transform qi, ascend clear qi and descend turbid qi, and regulate both the spleen and kidneys.

[0016] 2. Fenugreek is a medicinal herb that is also used as food. Inula japonica has been used clinically to relieve nausea in pregnant women and to treat mumps in children. Combinations of fenugreek and Inula japonica, as well as combinations of fenugreek extract and Inula japonica extract, are characterized by good safety.

[0017] 3. Fenugreek and its extracts have excellent hypoglycemic and lipid-lowering effects. Their main target organs are the liver, muscles, and intestines. They can regulate liver glucose metabolism enzymes, promote muscle glycogen synthesis, regulate intestinal amylase and glucosidase activity, and promote cholesterol excretion. Inula japonica and its extracts also have significant hypoglycemic and lipid-lowering effects. Their main target organs are the pancreas and intestines. They can protect the function of pancreatic islet β-cells and stimulate insulin secretion, while also promoting gastrointestinal motility, accelerating food excretion, and reducing absorption. Therefore, fenugreek and its extracts, combined with Inula japonica and its extracts, can exert multi-organ, multi-pathway, and multi-target effects to control abnormal blood glucose, improve hyperlipidemia, and protect pancreatic islet structure and function, which differs from existing chemical drugs for controlling blood glucose and lipids.

[0018] 5. Currently, there is a lack of single drugs in clinical practice that can simultaneously treat multiple characteristic factors of metabolic syndrome. Patients need to take multiple drugs at the same time, such as antidiabetic drugs (metformin, glimepiride, etc.), lipid-lowering drugs (atorvastatin, etc.), and antihypertensive drugs (nifedipine, etc.) to treat metabolic syndrome. However, the combination of fenugreek and inula japonica, as well as the combination of fenugreek extract and inula japonica extract, have multiple pharmacological effects, such as significantly lowering blood sugar, lowering triglycerides, improving glucose tolerance, improving hyperinsulinemia, promoting gastrointestinal motility, and reducing food absorption, which are beneficial for the control and treatment of metabolic syndrome.

[0019] 6. The combination of fenugreek and Inula japonica, as well as the combination of fenugreek extract and Inula japonica extract, has better efficacy than the individual raw materials and extracts. Attached Figure Description

[0020] Figure 1 Flowchart of extraction process and tablet preparation process of fenugreek extract and Inula japonica extract combination.

[0021] Figure 2 Effects of a combination of fenugreek extract and Inula japonica extract on glucose tolerance in diabetic mice

[0022] Figure 3 Pathological sections of pancreas from mice in the normal group, diabetic model group, combination drug administration group, and metformin group.

[0023] Figure 4 Pathological sections of the pancreas of mice in the normal group, pancreatitis model group, combination drug administration group, and metformin group. Detailed Implementation

[0024] The embodiments described below are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0025] Example 1: Preparation of Fenugreek Extract

[0026] Previous research in this invention has found that the main antidiabetic active ingredients in fenugreek include apigenin flavonoids, saponins, and fenugreekine. These components are all soluble in low-toxicity ethanol solvents. Therefore, this invention proposes to use three ethanol concentrations of 50%, 70%, and 95% to extract fenugreek raw materials, and to investigate the effects of different extraction temperatures, solvent amounts, and extraction times on the yield of extract, apigenin flavonoids, and saponins, so as to further optimize the extraction process.

[0027] 1. Medicinal materials and instruments

[0028] Fenugreek was purchased from Beijing Tongrentang Chongwenmen Pharmacy and pulverized before the experiment. Reference standards apigenin and diosgenin were purchased from the China National Institutes for Food and Drug Control.

[0029] Ultraviolet-Vis Spectrophotometer (UV-2000, Shanghai Unico Instruments Co., Ltd.)

[0030] 2. Experimental Methods

[0031] Three ethanol concentrations (50%, 70%, and 95%), three extraction temperatures (25°C, 50°C, and 100°C), three solvent volumes (6x, 8x, and 10x), and three extraction times (1, 2, and 3 times) were used in an orthogonal experimental design (L9(3)). 4 The method (see Table 1) was used to prepare fenugreek ethanol extract and further optimize the extraction process.

[0032] Table 1. Orthogonal experimental design for fenugreek ethanol extraction.

[0033]

[0034] 2.2 Determination methods for extract yield, apigenin flavonoids and saponins

[0035] (1) Method for determining extract yield

[0036] Use L9(3) 4 An orthogonal array was used to arrange the experiment. 100g of fenugreek powder was weighed and extracted according to the set scheme to obtain fenugreek viscous extract. The viscous extract was then placed in a vacuum drying oven at 55℃ and dried to constant weight. The weight was then measured and the yield of the dry extract was calculated according to the following formula.

[0037]

[0038] The content of apigenin flavonoids in fenugreek alcohol extract was determined by visible spectrophotometry, and then converted to the content of apigenin flavonoids per 100g of medicinal material. Specific experimental methods:

[0039] Preparation of the apigenin standard curve: Accurately weigh 5 mg of apigenin reference standard into a 25 ml volumetric flask, dissolve in methanol, and dilute to volume. Accurately transfer 0.0 ml, 0.5 ml, 1.0 ml, 1.5 ml, 2.0 ml, 2.5 ml, 3.0 ml, 4.0 ml, and 5.0 ml of apigenin standard solution into 10 ml volumetric flasks, add methanol to bring the volume to 5.0 ml, shake well, add 0.5 ml of 5% NaNO2 solution to the volumetric flask, shake well, add 0.5 ml of 10% Al(NO3)3 solution, shake well, add 4.0 ml of 4% NaOH solution, shake well, and finally dilute to volume with methanol. After standing at room temperature for 15 min, measure the absorbance value at a wavelength of λ440 nm. Plot the standard curve with the absorbance value as the ordinate (Y) and the apigenin standard solution concentration (μg / ml) as the abscissa (X), and calculate the linear regression equation.

[0040] Sample determination: Accurately weigh an appropriate amount of vacuum-dried fenugreek extract and place it in a 25ml volumetric flask. First, add 10ml of methanol and sonicate for 20min. Then, add another 10ml of methanol and sonicate for another 20min. Finally, add methanol to bring the volume to a final volume. Accurately transfer 2ml of this sample solution to a 10ml volumetric flask, add methanol to bring the volume to 5ml, shake well, add 0.5ml of 5% NaNO2 solution, shake well, add 0.5ml of 10% Al(NO3)3 solution, shake well, then add 4.0ml of 4% NaOH solution, and finally bring the volume to a final volume with methanol. After standing at room temperature for 15min, measure the absorbance at a wavelength of λ440nm. Calculate the content of apigenin flavonoid glycosides according to the standard curve equation.

[0041] (3) Method for determining saponin content

[0042] The saponin content in fenugreek dry extract was determined by visible spectrophotometry, and then converted to the saponin content per 100g of medicinal material. The specific experimental method is as follows:

[0043] Preparation of the standard curve: Accurately weigh 5 mg of diosgenin reference standard into a 25 ml volumetric flask, dissolve and dilute to volume with methanol. Accurately transfer 0.0 ml, 0.2 ml, 0.5 ml, 0.8 ml, 1.0 ml, 1.5 ml, 2.0 ml, 3.0 ml, and 4.0 ml of diosgenin standard solution into 10 ml spiral test tubes, respectively. Evaporate the solvent to dryness in an 80°C water bath. Then add 0.2 ml of 5% vanillin-glacial acetic acid solution, shake well, add 0.8 ml of perchloric acid, shake well, cap, and heat in a 70°C water bath for 20 min. Then remove and cool in an ice-water bath for 10 min. Transfer to a 10 ml volumetric flask, rinse the test tube three times with a small amount of glacial acetic acid, and transfer to the volumetric flask. Finally, dilute to volume with glacial acetic acid. Measure the absorbance at 550 nm. A standard curve was plotted with absorbance as the ordinate (Y) and the concentration of diosgenin standard solution (μg / ml) as the abscissa (X), and the linear regression equation was calculated.

[0044] Sample determination: Accurately weigh an appropriate amount of fenugreek sample and place it in a 25ml volumetric flask. First, add 10ml of methanol and sonicate for 20min, then add another 10ml of methanol and continue sonicating for 20min. Make up to volume with methanol. Accurately transfer 0.5ml of this solution to a 10ml threaded test tube, place it in an 80℃ water bath to evaporate the solvent, add 0.2ml of 5% vanillin-glacial acetic acid solution, shake well, then add 0.8ml of perchloric acid, cap and shake well. Heat in a 70℃ water bath for 20min, then remove and cool in an ice-water bath for 10min. Transfer the solution to a 10ml volumetric flask, rinse the test tube three times with a small amount of glacial acetic acid, and transfer the rinsed solution to the volumetric flask. Finally, make up to volume with glacial acetic acid. Measure the absorbance at a wavelength of λ550nm. Calculate the saponin content based on the standard curve.

[0045] 2.3 Experimental Results

[0046] The effects of different ethanol concentrations, extraction temperatures, solvent dosages, and extraction times on the yield and effective component content of fenugreek alcohol extract are shown in Table 2.

[0047] Table 2 Fenugreek alcohol extract L9(3) 4 Orthogonal Experiment and Results Table

[0048]

[0049] Based on the above experimental results, this invention suggests that using 50%–95% ethanol as a solvent, an extraction temperature of 25℃–100℃, a solvent volume of 6–8 times (w / v), and 1–3 extractions are all suitable for preparing fenugreek ethanol extracts. Further optimized extraction conditions include an ethanol concentration of 50%–70%, a solvent volume of 8–10 times, 2–3 extractions, and an extraction temperature of 25℃–100℃. The optimal extraction conditions are A2B2C2D2, i.e., 70% ethanol, 8 times solvent volume, 2 extractions, and an extraction temperature of 50℃. Further process verification results are shown in Table 3.

[0050] Table 3. Validation results of fenugreek ethanol extraction process A2B2C2D2

[0051]

[0052] Example 2: Preparation of Inula japonica extract

[0053] Previous studies of this invention have found that the active ingredients in Inula japonica that fight diabetes are mainly water-soluble flavonoids and polysaccharides. These ingredients are easily soluble in water and low concentrations of ethanol (≤50%). Therefore, this invention first uses water as a solvent to investigate the effects of different extraction temperatures, solvent amounts, and extraction times on the yield of the extract, apigenin flavonoids, and saponins.

[0054] 1. Medicinal materials and instruments

[0055] The Inula japonica herb was purchased from Beijing Tongrentang Chongwenmen Pharmacy. Reference standards rutin and glucose were purchased from the China National Institutes for Food and Drug Control.

[0056] Ultraviolet-Vis Spectrophotometer (UV-2000, Shanghai Unico Instruments Co., Ltd.)

[0057] 2. Experimental Methods

[0058] 2.1 Extraction of Inula japonica using water as solvent

[0059] 2.1.1 Orthogonal Experimental Design

[0060] Three extraction temperatures (25℃, 50℃, and 100℃), three solvent volumes (8x, 12x, and 16x), and three extraction times (1, 2, and 3 times) were used, and an orthogonal experimental design (L9(3)) was employed. 4 The method (see Table 4) was used to prepare fenugreek ethanol extract and further optimize the extraction process.

[0061] Table 4. Orthogonal experimental design for extraction of water extract from Inula japonica.

[0062]

[0063] 2.1.2 Determination of extract yield, flavonoid glycosides and reducing sugars

[0064] (1) Method for determining the yield of extract

[0065] Use L9(3) 3 An orthogonal array was used to design an experiment. 100g of Inula japonica was weighed and extracted according to the set scheme to obtain a water-extracted dry extract of Inula japonica. The extract was dried to constant weight in a vacuum drying oven at 55℃. The dry extract yield was then calculated.

[0066]

[0067] (2) Method for determining flavonoid glycoside content

[0068] The flavonoid glycoside content in the dry extract was determined using the UV method, and then converted to the flavonoid glycoside content per 100g of medicinal material. The specific experimental method is as follows:

[0069] Preparation of the standard curve: Accurately weigh 8 mg of rutin reference standard into a 50 ml volumetric flask, dissolve in methanol, and dilute to volume. Accurately transfer 0.0 ml, 0.5 ml, 1.0 ml, 1.5 ml, 2.0 ml, 3.0 ml, 4.0 ml, and 5.0 ml of the rutin standard solution into 10 ml volumetric flasks, add methanol to bring the volume to 5.0 ml, shake well, add 0.5 ml of 5% NaNO2 solution to the volumetric flask, shake well, add 0.5 ml of 10% Al(NO3)3 solution, shake well, then add 4.0 ml of 4% NaOH solution, shake well, let stand at room temperature for 15 min, and finally dilute to volume with methanol. Measure the absorbance at a wavelength of λ510 nm. Plot the standard curve with absorbance as the ordinate (Y) and rutin standard solution concentration (μg / ml) as the abscissa (X), and calculate the linear regression equation.

[0070] Sample determination: Accurately weigh an appropriate amount of vacuum-dried Inula japonica extract and place it in a 25ml volumetric flask. First, add 10ml of water and sonicate for 20min. Then, add another 10ml of water and sonicate for another 20min. Finally, add water to bring the volume to a final volume. Accurately transfer 2ml of the test solution to a 10ml volumetric flask, add methanol to bring the volume to 5ml, shake well, add 0.5ml of 5% NaNO2 solution, shake well, add 0.5ml of 10% Al(NO3)3 solution, shake well, then add 4.0ml of 4% NaOH solution and bring the volume to a final volume with methanol. Measure the absorbance at a wavelength of λ510nm and calculate the flavonoid glycoside content based on the standard curve.

[0071] (3) Method for determining reducing sugar content

[0072] The sugar content in the dry extract was determined using the UV method, and then converted to the sugar content per 100g of medicinal material. The specific experimental method is as follows:

[0073] Preparation of the standard curve: Accurately weigh 4.2 mg of glucose standard dried at 105℃ into a 25 ml volumetric flask, dissolve and dilute to volume with water to a concentration of 0.168 mg / ml. Accurately pipette 0.0 ml, 0.1 ml, 0.2 ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, and 0.7 ml of glucose standard solution into 10 ml test tubes, respectively, and accurately add water to bring the volume to 1.0 ml. Add 4.0 ml of anthrone reagent in an ice-water bath, cap, shake well, and heat in a boiling water bath for 7 min. Immediately after heating, place the tubes in an ice-water bath to cool for 20 min, and then measure the absorbance at a wavelength of λ620 nm. Plot the standard curve with absorbance as the ordinate (Y) and glucose standard solution concentration (μg / ml) as the abscissa (X).

[0074] Sample determination: Accurately weigh an appropriate amount of dried Inula japonica extract into a 25ml volumetric flask, add 10ml of water and sonicate for 20min, then add another 10ml of water and sonicate for another 20min, finally dilute to volume with water. Accurately transfer 0.2ml of this solution into a 10ml capped test tube, add 0.8ml of water to make up to 1ml, shake well, add 4.0ml of 0.2% anthrone reagent in an ice-water bath, cap and shake well, heat in a boiling water bath for 10min, remove and cool in an ice-water bath, then measure the absorbance at a wavelength of λ620nm, and calculate the sugar content according to the standard curve.

[0075] 2.1.3 Experimental Results

[0076] The effects of different extraction temperatures, solvent dosages, and extraction times on the yield, flavonoid glycosides, and reducing sugar content of Inula japonica water extract are shown in Table 5.

[0077] Table 5. Water extract of Inula japonica L9 (3) 3 Orthogonal experiment results

[0078]

[0079] Based on the above experimental results, this invention suggests that water can be used as the solvent, with an extraction temperature of 25℃ to 100℃, a solvent volume of 8 to 16 times (w / v), and 1 to 3 extractions. A solvent volume of 12 to 16 times, 2 to 3 extractions, and an extraction temperature of 50℃ to 100℃ are also acceptable. The optimal extraction conditions are A2B2C2, i.e., an extraction temperature of 50℃, a solvent volume of 12 times, and 2 extractions. Further process verification results are shown in Table 6.

[0080] Table 6. Results of the verification test on the extraction process of Inula japonica.

[0081]

[0082] 2.2 Preparation of 50% alcohol extract of Inula japonica using 50% ethanol as solvent

[0083] Inula japonica extract was prepared using 50% ethanol as solvent, at an extraction temperature of 50℃, a solvent ratio of 12, and two extractions. The effects on extract yield, flavonoid glycosides, and reducing sugar content are shown in Table 7.

[0084] Table 7. Effect of using 50% ethanol as solvent on the yield and effective components of Inula japonica extract.

[0085]

[0086] As can be seen from Table 4, under the same conditions, the yield, flavonoid glycoside and reducing sugar content of the extract obtained by using 50% ethanol as a solvent are all lower than those obtained by using water as a solvent. It is speculated that the concentration of 50% ethanol will affect the dissolution of polysaccharide components with large molecular weight in Inula japonica.

[0087] Example 3: Preparation of 95% Fenugreek alcohol extract, n-butanol or acetone extract

[0088] Fenugreek seed powder was extracted twice with 95% ethanol at a solvent volume of 10 times (w / v) within the range of 50℃ to 60℃. The extracts were combined, filtered, and the filtrate was concentrated under reduced pressure at 55℃ to obtain a 1:1 volume concentrate. The concentrate was transferred to a separatory funnel, and n-butanol or acetone was added at a volume ratio of 1:1 for extraction. This process was repeated three times. The separated extracts were combined, concentrated under reduced pressure at 45℃, the solvent was evaporated, and the extract was then vacuum dried to prepare the n-butanol or acetone extract of fenugreek. This method can further enrich the anti-diabetic active components and active ingredients in fenugreek and remove ineffective oily components from the 95% ethanol extract. The results are shown in Table 8.

[0089] Table 8. Fenugreek extracts obtained from 95% ethanol, n-butanol, or acetone extractions

[0090]

[0091] Example 4: Tablet preparation process of a combination of fenugreek extract and Inula japonica extract

[0092] Fenugreek and Inula japonica are used as the two medicinal materials. Tablets are prepared by combining the alcoholic extract of fenugreek and the aqueous extract of Inula japonica according to the following process flow. The specific process is detailed below. Figure 1 .

[0093] Example 5: Evaluation of the hypoglycemic activity of fenugreek 95% ethanol extract and n-butanol extract

[0094] 1. Experimental Materials

[0095] 1.1 Mice: Kunming mice, male, 18-22g, provided by the Experimental Animal Center of the Academy of Military Medical Sciences.

[0096] 1.2 Test substance: (1) Fenugreek 95% ethanol extract (prepared according to the method in Example 3)

[0097] (2) n-Butanol extract (prepared according to the method in Example 3)

[0098] 1.3 Instruments:

[0099] One Touch rapid blood glucose meter TM Basic TM Plus model, manufactured by Johnson & Johnson's Recombinant Human, (with blood glucose test strips included);

[0100] Electronic balance: Manufactured by Sartorious GmbH, Germany

[0101] 2. Experimental Methods

[0102] 2.1 Modeling Method

[0103] Kunming mice were randomly divided into a normal group and a model-design group. Mice in the model-design group were fasted for 16 hours (with no restriction on water intake), and then rapidly injected with alloxan saline solution via the tail vein at a dose of 50–60 mg / kg. 96 hours later, blood was collected from the tail tip, and random blood glucose levels were measured using a glucometer. Mice with blood glucose levels >20.0 mmol / L, accompanied by polyphagia, polydipsia, and polyuria, were selected as diabetic model mice.

[0104] 2.2 Route and volume of administration

[0105] Administration route: all were administered by gavage;

[0106] Dosage volume: 0.1 mL / 10 g body weight for mice

[0107] 2.3 Observation Indicators

[0108] Random blood glucose test

[0109] 2.4 Statistical Methods

[0110] All data obtained were quantitative data, and parametric statistics were used for statistical analysis. The mean and standard deviation were calculated, and the t-test was used to determine the significance of differences between different groups. A p-value < 0.05 was considered a significant difference.

[0111] 3. Experimental Results

[0112] (1) Hypoglycemic activity of 95% ethanol extract of fenugreek

[0113] The 95% ethanol extract of fenugreek prepared according to the method in Example 1 was administered to alloxan-induced diabetic mice by gavage at a dose of 1000 mg / kg for 21 consecutive days. Random blood glucose levels were measured before administration (day 0), day 7, day 14, and day 21, and the results are shown in Table 8.

[0114] Table 8. Effects of 95% Fenugreek ethanol extract on random blood glucose in alloxan-induced diabetic mice.

[0115]

[0116] Note: Compared with the normal group *** p < 0.001; compared with the model group, Δ p < 0.05, n = 9.

[0117] (2) Hypoglycemic activity of n-butanol extract of 95% fenugreek ethanol extract.

[0118] The n-butanol extract of 95% ethanol extract of fenugreek was prepared according to the method in Example 3, and its antidiabetic activity was evaluated according to the experimental method in Example 5. The results are shown in Tables 9 and 10. The experimental results show that the n-butanol extract of 95% ethanol extract of fenugreek at a dose of 1000 mg / kg has a significant hypoglycemic effect on diabetic mice.

[0119] Table 9. Effects of 95% Fenugreek ethanol extract and n-butanol extract on random blood glucose in diabetic mice.

[0120]

[0121] Note: Compared with the normal group *** p < 0.001; compared with the model group, Δ p < 0.05 ΔΔ p < 0.01, n = 8.

[0122] Example 6: Hypoglycemic activity of fenugreek 70% ethanol extract

[0123] Fenugreek extract is prepared using 70% ethanol, which has several advantages: (1) ethanol has good safety; (2) compared with 95% ethanol, using 70% ethanol to extract fenugreek seeds can reduce the leaching of oils (ineffective components); (3) it is beneficial for the extraction of active ingredients such as apigenin flavonoids, saponins, and fenugreekine. See Example 1 for the specific preparation method. Gliclazide was produced by Servier Pharmaceuticals (France) and Tianjin Huajin Pharmaceutical Factory.

[0124] Following the efficacy evaluation method in Example 5, the antidiabetic activity of the 70% ethanol extract of fenugreek was evaluated. The 70% ethanol extract of fenugreek was administered to alloxan-treated mice by gavage at two doses, 500 and 1000 mg / kg, for 22 days. The effects on blood glucose levels in the mice are shown in Table 10. The results showed that both 500 and 1000 mg / kg doses of the 70% ethanol extract of fenugreek significantly reduced random blood glucose in diabetic mice, and its activity was superior to that of the positive control drug gliclazide.

[0125] Table 10 Effects of 70% Fenugreek Alcohol Extract on Random Blood Glucose in Alloxan-Induced Diabetic Mice

[0126]

[0127] Note: Compared with the normal group *** p < 0.001; compared with the model group, Δ p < 0.05, n = 10.

[0128] Example 7: Evaluation of the hypoglycemic activity of Inula japonica water extract and 50% alcohol extract

[0129] Aqueous extracts and 50% ethanol extracts of Inula japonica were prepared according to the method in Example 2. The antidiabetic activity of the Inula japonica extracts was evaluated according to the efficacy evaluation method in Example 5. Both the aqueous extract and the 50% ethanol extract were administered to alloxan-induced diabetic mice by gavage at a dose of 1000 mg / kg for 20 days and 18 days, respectively. The effects on blood glucose levels in the mice are shown in Tables 11 and 12, respectively. The results indicate that both the aqueous extract and the 50% ethanol extract of Inula japonica possess hypoglycemic activity.

[0130] Table 11. Effects of Inula japonica extract on random blood glucose in alloxan-induced diabetic mice

[0131]

[0132] Note: Compared with the normal group *** p < 0.001; compared with the model group, Δ p < 0.05 ΔΔ p < 0.01, n = 10.

[0133] Table 12. Effects of 50% ethanol extract of Inula japonica on random blood glucose in diabetic mice.

[0134]

[0135] Note: Compared with the normal group *** p < 0.001; compared with the model group, Δ p < 0.05, n = 10.

[0136] Example 8: Evaluation of the hypoglycemic activity of a combination of 70% fenugreek ethanol extract and Inula japonica water extract

[0137] 70% fenugreek alcohol extract (A) and Inula japonica water extract (B) were mixed at a total dose of 400 mg / kg and formulated into formulations of fenugreek alcohol extract: Inula japonica water extract in the proportions of 300 mg / kg: 100 mg / kg (A1B3), 200 mg / kg: 200 mg / kg (A2B2), and 100 mg / kg: 300 mg / kg (A3B1), respectively. Then, following the efficacy evaluation method in Example 5, alloxan was administered to diabetic mice by gavage for 23 days. Fasting blood glucose and random blood glucose were measured in the mice at 0, 10, 15, 22, and 23 days after administration. The results are shown in Table 13. The results showed that when 70% ethanol extract of fenugreek and aqueous extract of Inula japonica were administered to diabetic mice at a total dose of 400 mg / kg, in combinations of 300 mg / kg:100 mg / kg (A1B3), 200 mg / kg:200 mg / kg (A2B2), and 100 mg / kg:300 mg / kg respectively, all showed good hypoglycemic effects. The A1B3 combination showed better effects on postprandial blood glucose, while A3B1 was more effective than A1B3 in controlling fasting blood glucose. The combination of 200 mg / kg:200 mg / kg (A2B2) had significant hypoglycemic effects on both random blood glucose and fasting blood glucose, and was superior to A1B3 and A3B1, as well as metformin.

[0138] Table 13 Effects of fenugreek extract and Inula japonica extract on blood glucose levels in diabetic mice

[0139]

[0140] Note: Compared with the normal control group *** p < 0.001; compared with the diabetes model group, Δ p < 0.05 ΔΔ p < 0.01, n = 12.

[0141] Example 9: Evaluation of the lipid-lowering activity of a combination of 70% fenugreek ethanol extract and Inula japonica water extract

[0142] 1. Experimental Materials

[0143] 1.1 Rats: SD, male, 200-250g, provided by the Experimental Animal Center of the Academy of Military Medical Sciences.

[0144] 1.2 Test substance: (1) Fenugreek 70% ethanol extract (prepared according to the method in Example 3)

[0145] (2) Inula japonica water extract (prepared according to the method in Example 2)

[0146] 1.3 Instruments:

[0147] One Touch rapid blood glucose meter TM Basic TM Plus model, manufactured by Johnson & Johnson's Recombinant Human, (with blood glucose test strips included);

[0148] Automated Biochemical Analyzer: Model 7170S, manufactured by Hitachi.

[0149] FT-630 Microcomputer Multi-Probe Radioimmunoassay Analyzer: Beijing Nuclear Instrument Factory

[0150] Total Cholesterol, Triglycerides and HDL-Cholesterol Reagent Kit: Zhejiang Dongou Biotechnology Co., Ltd.

[0151] Insulin Radioimmunoassay Kit: Beijing Furui Biotechnology Co., Ltd.

[0152] Electronic balance: Manufactured by Sartorious GmbH, Germany

[0153] 2. Experimental methods and results

[0154] SD rats were fed a high-sugar and high-fat diet for 45 days, followed by overnight fasting. A low-dose STZ (30 mg / kg) was injected via the tail vein, and the rats were then fed a high-sugar and high-fat diet for another 15 days, inducing significant hyperglycemia and hyperlipidemia (one of the types 2 diabetes models). They were then administered a combination of 70% fenugreek ethanol extract and Inula japonica water extract (weight ratio 1:1) at total doses of 500 mg / kg and 1000 mg / kg, respectively. Metformin (200 mg / kg) and gliclazide (50 mg / kg) were used as positive control agents. The diabetic rats were administered the drug by gavage for 55 days. Random blood glucose levels were measured on days 0, 15, 30, and 55 after administration. Fasting blood glucose levels were measured on day 45 after overnight fasting. On day 55, blood was collected from the orbital sinus, and the rats were sacrificed. Plasma levels of total cholesterol, triglycerides, HDL-cholesterol (HDL-C), and LDL-cholesterol were measured. The results are shown in Tables 14 and 15. The results showed that the combination of fenugreek and Inula japonica extract at 500 mg / kg and 1000 mg / kg could significantly reduce blood glucose, plasma triglyceride and LDL-cholesterol levels in type 2 diabetic rats induced by high glucose and high lipid, and its hypoglycemic and lipid-lowering effects were comparable to those of metformin.

[0155] Table 14. Effects of Bafenzi tablets on blood glucose in type 2 diabetic rats induced by high glucose and high fat intake.

[0156]

[0157] Note: Compared with the normal group *** p < 0.001; compared with the model group, ΔΔΔ p < 0.001 ΔΔ p < 0.01, Δ p < 0.05, n = 12.

[0158] Table 15. Effects of Bafenzi tablets on blood lipids in experimental type 2 diabetic rats

[0159]

[0160] Note: Compared with the normal group * p < 0.05 ** p < 0.001; compared with the model group, ΔΔ p < 0.01, Δ p < 0.05, n = 12.

[0161] Example 10: Evaluation of the effect of a combination of 70% fenugreek ethanol extract and Inula japonica water extract on improving glucose tolerance.

[0162] 1. Experimental Materials

[0163] 1.1 Rats: SD, male, 200-250g, provided by the Experimental Animal Center of the Academy of Military Medical Sciences.

[0164] 1.2 Test substance: (1) Fenugreek 70% ethanol extract (prepared according to the method in Example 3)

[0165] (2) Inula japonica water extract (prepared according to the method in Example 2)

[0166] 1.3 Instruments:

[0167] One Touch rapid blood glucose meter TM Basic TM Plus model, manufactured by Johnson & Johnson's Recombinant Human, (with blood glucose test strips included);

[0168] 2. Experimental methods and results

[0169] SD rats were fasted overnight and then injected with 70 mg / kg alloxan via the tail vein. Hyperglycemia symptoms appeared three days later. The experiment was divided into a normal control group (administered with saline), a diabetic model group (administered with saline), two groups (weight ratio 1:1, total doses of 200 mg / kg and 400 mg / kg respectively) of a 70% fenugreek ethanol extract and an Inula japonica water extract, and a metformin group (200 mg / kg). All rats were administered the medication by gavage for 24 consecutive days, followed by overnight fasting. Each group was then administered 2.5 g / kg of glucose solution by gavage. Blood glucose levels were measured in each rat at 30, 60, 120, and 180 minutes after glucose administration to compare glucose tolerance in different groups. The results are shown in Table 16. Figure 2 The results showed that, compared with the diabetic model group, metformin had a better hypoglycemic effect than the combination 30 minutes after gavage glucose administration. However, the glucose tolerance of the combination at a dose of 400 mg / kg was basically the same as that of metformin during the period of 60 min to 180 min after administration, suggesting that the combination of fenugreek alcohol extract and Inula japonica water extract has a significant tolerance to glucose shock.

[0170] Table 16. Effects of the combination of fenugreek alcohol extract and Inula japonica water extract on glucose tolerance in diabetic rats.

[0171]

[0172] Note: Compared with the normal group *** p < 0.001 ** p < 0.01; compared with the model group, ΔΔΔ p < 0.001 ΔΔ p < 0.01, Δ p < 0.05, n = 5. Metformin.

[0173] Example 11: Effect of a combination of 70% fenugreek ethanol extract and Inula japonica aqueous extract on insulin resistance

[0174] 1. Experimental Materials

[0175] 1.1 Mice: Male insulin-resistant diabetic KK-Ay mice with random blood glucose levels >11.1 mmol / L on any two days were selected and provided by Peking Union Medical College Hospital Laboratory Animal Center.

[0176] 1.2 Test substance: (1) Fenugreek 70% ethanol extract (prepared according to the method in Example 3)

[0177] (2) Inula japonica water extract (prepared according to the method in Example 2)

[0178] (3) Rosiglitazone maleate, manufactured by GlaxoSmithKline (Tianjin) Co., Ltd.

[0179] 2. Experimental methods and results

[0180] Male KK-ay mice were randomly divided into four groups: a diabetic model group, two groups receiving a combination of 70% ethanol extract of fenugreek and aqueous extract of Inula japonica (weight ratio 1:1, total doses of 400 mg / kg and 800 mg / kg, respectively), and a rosiglitazone positive control group (1.04 mg / kg). All mice were administered the metformin (200 mg / kg) by gavage for 50 days, after which they were sacrificed, and blood was collected from the orbital sinus to measure plasma blood glucose and insulin levels (plasma insulin levels were measured using a double-antibody sandwich ABC-ELISA method). The results are shown in Tables 17 and 18. The results indicated that compared with the insulin-resistant diabetic KK-Ay model mice, gavage administration of the combination of 70% ethanol extract of fenugreek and aqueous extract of Inula japonica at doses of 400 and 800 mg / kg significantly reduced blood glucose levels, decreased plasma insulin levels, and alleviated insulin resistance, with effects comparable to the positive control drug rosiglitazone.

[0181] Table 17. Effects of the combination of fenugreek ethanol extract and Inula japonica aqueous extract on random blood glucose in insulin-resistant diabetic KK-Ay mice.

[0182]

[0183] Note: Compared with the diabetes model group: * p < 0.05; ** p < 0.01.

[0184] Table 18. Effects of the combination of fenugreek ethanol extract and Inula japonica aqueous extract on insulin levels in insulin-resistant KK-Ay diabetic mice.

[0185]

[0186] Note: Compared with the diabetes model group: * p < 0.05; ** p < 0.01.

[0187] Example 12: Effects of a combination of fenugreek alcohol extract and Inula japonica water extract on blood glucose and pancreas in insulin-producing mice

[0188] 1. Experimental Materials

[0189] 1.1 Mice: Kunming mice, male, 18-22g, provided by the Experimental Animal Center of the Academy of Military Medical Sciences.

[0190] 1.2 Test substance: (1) Fenugreek 70% ethanol extract (prepared according to the method in Example 3)

[0191] (2) Inula japonica water extract (prepared according to the method in Example 2)

[0192] 1.3 Instruments:

[0193] One Touch rapid blood glucose meter TM Basic TM Plus model, manufactured by Johnson & Johnson's Recombinant Human, (with blood glucose test strips included);

[0194] Electronic balance: Manufactured by Sartorious GmbH, Germany

[0195] 2. Experimental methods and results

[0196] Male Kunming mice were divided into a normal control group and a model group. Mice in the model group were intraperitoneally injected with 30 mg / kg streptozotocin (STZ) every other day for 9 consecutive days (18 days in total), and the mice gradually developed hyperglycemia. From the start of STZ injection, mice were administered a combination of 70% ethanol extract of fenugreek and aqueous extract of Inula japonica by gavage at a total dose of 400 mg / kg (200 mg / kg each) once daily for 19 days. Random blood glucose levels were measured on day 18, followed by administration of the drug, and blood glucose was measured 1 hour later. Mice were sacrificed, and the pancreas was harvested, fixed in neutral formaldehyde, and subjected to pathological analysis. The effects of the 70% ethanol extract of fenugreek and aqueous extract of Inula japonica on blood glucose levels in mice are shown in Table 19, and the effects on the pancreas of mice with ischemia are shown in Table 19. Figure 4 The results showed that oral administration of a combination of fenugreek alcohol extract and Inula japonica water extract at 400 mg / kg to STZ-induced mice for 18 days significantly inhibited the rise in blood glucose levels. Pre-administration random blood glucose levels were significantly lower than in the model group, and the hypoglycemic effect was comparable to that of metformin. One hour after administration, blood glucose continued to decrease, but the effect of metformin was more pronounced.

[0197] from Figure 4 The study showed that the pancreas of mice in the islet inflammation model group was atrophied, with broken and irregular edges. Numerous inflammatory cells infiltrated the pancreas near blood vessels, and the number of islet cells was reduced. Islet cell pathologies included deep nuclear staining, nuclear pyknosis, cell collapse, absence, and deformation. In contrast, mice administered the 400 mg / kg combination showed an increased number of islet cells in their pancreas, with no inflammatory cell infiltration within the islets. The cell size, arrangement, and regularity of the nuclei were significantly better than in the model group. This suggests that the combination of 70% fenugreek ethanol extract and Inula japonica water extract can inhibit the infiltration of inflammatory cells into the islets and protect the number and function of islet cells.

[0198] Table 19. Effects of the combination of fenugreek alcohol extract and Inula japonica water extract on random blood glucose in pancreatitis diabetic mice.

[0199]

[0200] Note: Compared with the normal group *** p < 0.001 *p < 0.05; compared with the model group, ΔΔ p < 0.01, Δ p < 0.05, n = 10.

[0201] Example 13: Effect of the combination of fenugreek alcohol extract and Inula japonica water extract on gastrointestinal motility.

[0202] 1. Experimental Materials

[0203] 1.1 Mice: Kunming mice, male, 18-22g, provided by the Experimental Animal Center of the Academy of Military Medical Sciences.

[0204] 1.2 Test substance: (1) Fenugreek 70% ethanol extract (prepared according to the method in Example 3)

[0205] (2) Inula japonica water extract (prepared according to the method in Example 2)

[0206] 2. Experimental Methods

[0207] First, a physiological saline containing 5% charcoal and 10% gelatin was prepared. This saline was then used to prepare a combination of fenugreek extract and Inula japonica extract (prepared according to the method in Example 3) and the positive control drug pyridostigmine bromide, with each drug being administered at a volume of 0.2 mL / 10 g.

[0208] Thirty 20-22g Kunming mice were fasted for 16 hours and then divided into three groups: a normal control group, a combination group of fenugreek extract and Inula japonica extract, and a pyridostigmine bromide group (40 mg / kg, ig). Mice in the normal control group were administered charcoal-containing saline by gavage, while mice in the combination group and the pyridostigmine bromide group were administered the charcoal at a dose of 400 mg / kg and pyridostigmine bromide at a dose of 40 mg / kg, respectively. Mice were sacrificed 25 minutes after administration, and the abdominal cavity was dissected, removing the segment from the pylorus to the rectum. The distance the charcoal powder traveled at the very tip and the total length of the intestine were measured, and the proportion of the distance traveled by the charcoal powder to the total intestinal length was calculated.

[0209] 3. Experimental Results

[0210] The effects of a 70% ethanolic extract of fenugreek and an aqueous extract of Inula japonica (weight ratio 1:1) administered to normal mice by gavage at a dose of 400 mg / kg on gastrointestinal motility are shown in Table 20. The results showed that, compared with the normal control group, administration of the 400 mg / kg combination of the 70% ethanolic extract of fenugreek and the aqueous extract of Inula japonica significantly improved gastrointestinal motility in mice, with an effect comparable to that of the positive control drug pyridostigmine bromide.

[0211] Table 20. Effects of the combination of 70% ethanol extract of fenugreek and aqueous extract of Inula japonica on gastrointestinal motility in mice.

[0212]

[0213] Note: Compared with the normal control group, *P<0.05, n=10.

Claims

1. A traditional Chinese medicine composition for metabolic disorders, characterized in that, The active ingredients are made from the following raw materials in parts by weight: fenugreek 6-60 parts and Inula japonica 6-60 parts.

2. The traditional Chinese medicine composition according to claim 1, wherein the active ingredients are made from the following raw materials in parts by weight: 10-30 parts of fenugreek and 10-30 parts of Inula japonica.

3. According to claim 1, the active ingredient is made from the following raw materials in parts by weight: 10 parts fenugreek and 12 parts Inula japonica.

4. A traditional Chinese medicine composition for metabolic disorders, characterized in that, The active ingredients are made from the following raw materials in parts by weight: 1-20 parts fenugreek extract and 1-25 parts Inula japonica extract.

5. The traditional Chinese medicine composition according to claim 4, wherein the active ingredients are made from the following raw materials in parts by weight: 1-10 parts of fenugreek extract and 1-10 parts of Inula japonica extract.

6. The traditional Chinese medicine composition according to claim 4, wherein the active ingredients are made from the following raw materials in parts by weight: 1-3 parts fenugreek extract and 1-3 parts Inula japonica extract; more preferably.

7. The traditional Chinese medicine composition according to claim 4, wherein the active ingredients are made from the following raw materials in parts by weight: 1 part fenugreek extract and 1 part Inula japonica extract.

8. The traditional Chinese medicine composition according to any one of claims 4-6, wherein the fenugreek extract is a fenugreek ethanol extract.

9. In the traditional Chinese medicine composition according to claim 8, the extraction solvent for fenugreek extract is 30% to 95% ethanol.

10. In the traditional Chinese medicine composition according to claim 8, the extraction solvent for fenugreek extract is 50% to 70% ethanol.

11. The traditional Chinese medicine composition according to any one of claims 4-8, wherein the extraction temperature of fenugreek extract is 0℃~100℃.

12. The traditional Chinese medicine composition according to claim 11, wherein the extraction temperature of fenugreek extract is 20℃~80℃.

13. The traditional Chinese medicine composition according to claim 11, wherein the extraction temperature of fenugreek extract is 50℃~70℃.

14. The herbal extract according to any one of claims 5-7, characterized in that, Fenugreek extract is prepared by extracting fenugreek with n-butanol or acetone or by extracting fenugreek ethanol extract.

15. The Inula japonica extract according to claim 7, characterized in that, The extraction solvent is water or water-ethanol extract.

16. The Inula japonica extract according to claim 15, wherein the extraction solvent is less than 50% ethanol.

17. The Inula japonica extract according to claim 16, wherein the extraction solvent is less than 30% ethanol.

18. The Inula japonica extract according to claim 17, wherein the extraction solvent is water.

19. The traditional Chinese medicine composition according to any one of claims 15-18, wherein the extraction temperature of the Inula japonica extract is 0℃~100℃.

20. The traditional Chinese medicine composition according to any one of claims 15-18, wherein the extraction temperature of the Inula japonica extract is 20℃~80℃.

21. The traditional Chinese medicine composition according to any one of claims 15-18, wherein the temperature range of the Inula japonica extract is 50℃~70℃.

22. The use of the composition according to any one of claims 1-7 in the preparation of a medicament for the prevention and treatment of diabetes, characterized in that: An oral formulation is made by adding the active ingredient to a drug-acceptable carrier.

23. The use of the composition according to any one of claims 1-7 in the preparation of a medicament for the prevention and treatment of hyperlipidemia, characterized in that: An oral formulation is made by adding the active ingredient to a drug-acceptable carrier.

24. The use of the fenugreek n-butanol extract or acetone extract according to claim 14 in the preparation of a medicament for the prevention and treatment of diabetes, characterized in that: The pharmaceutical composition is an oral formulation made by adding the active ingredient to a pharmaceutically acceptable carrier.

25. The use of the fenugreek n-butanol extract or acetone extract according to claim 14 in the preparation of a medicament for the prevention and treatment of hyperlipidemia, characterized in that: The pharmaceutical composition is an oral formulation made by adding the active ingredient to a pharmaceutically acceptable carrier.

26. The use of the composition according to any one of claims 1-7 in the preparation of a medicament for protecting the morphology, number, and insulin secretion function of pancreatic islets, characterized in that: The pharmaceutical composition is an oral formulation made by adding the active ingredient to a pharmaceutically acceptable carrier.

27. The use of the composition of the raw materials and extracts according to claims 1-7 in the preparation of a medicament for the prevention and treatment of pancreatitis, characterized in that: The pharmaceutical composition is an oral formulation made by adding the active ingredient to a pharmaceutically acceptable carrier.

28. The use of the composition of the raw materials and extracts according to claims 1 to 7 in the preparation of a medicament for promoting gastrointestinal motility and treating constipation, characterized in that: The pharmaceutical composition is an oral formulation made by adding the active ingredient to a pharmaceutically acceptable carrier.

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