Traditional Chinese medicine compound preparation based on IR model signal channel and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, and discloses a traditional Chinese medicine compound preparation based on an IR model signal channel and a preparation method of the traditional Chinese medicine compound preparation. 10%-15% of rheum officinale; 15%-20% of mulberry leaves; 20%-30% of radix puerariae; 10%-15% of bitter gourd; 5%-10% of fresh ginger; 5%-10% of cinnamon; according to the traditional Chinese medicine compound preparation, an I RS-GSK3beta-GLUT4 signal channel is regulated and controlled through a specific mechanism so as to improve insulin resistance. By optimizing the ratio of the medicinal materials, the regulating effect on an IR model signal channel is remarkably enhanced, the insulin sensitivity is improved, and meanwhile, the continuous and stable release of the drug effect is realized, so that a more effective solution is provided for the comprehensive treatment of the type 2 diabetes mellitus.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine compound preparation based on an IR model signal pathway and a preparation method thereof. Background Art

[0002] Chinese herbal compound preparations are used in traditional medicine to treat various diseases. The IR (insulin resistance) model signaling pathway is an important theoretical basis for studying the mechanism of insulin resistance. Through this model, the molecular mechanism of insulin resistance can be clarified, and targeted treatment strategies can be developed. In recent years, Chinese herbal compound preparations based on the IR model have become a hot spot for research and development, with the aim of providing safer and more effective treatment options for type 2 diabetes through natural medicines.

[0003] In the prior art, a variety of Chinese herbal compound preparations have been studied for regulating the IR model signaling pathway, such as improving insulin sensitivity by affecting GSK3β and regulating the expression of GLUT4. These preparations often include herbs such as coptis root, rhubarb, kudzu root, mulberry leaf and bitter melon, which enhance the cell response to insulin by affecting specific molecular targets, thereby controlling blood sugar levels to a certain extent.

[0004] Although existing Chinese medicine compound preparations have shown potential in regulating the signal pathways of the IR model, there are still some shortcomings. First, they are unable to comprehensively regulate multiple signal pathways, resulting in limited therapeutic effects. In addition, existing preparations often lack highly targeted ingredient combinations and cannot effectively integrate the synergistic effects of multiple medicinal materials, thereby limiting their scope of clinical application and effectiveness. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides a Chinese medicine compound preparation based on the IR model signal pathway and a preparation method thereof. The present invention optimizes the ratio of medicinal materials, significantly enhances the regulatory effect on the IR model signal pathway, improves insulin sensitivity, and achieves sustained and stable release of drug efficacy, thereby providing a more effective solution for the comprehensive treatment of type 2 diabetes.

[0006] To achieve the above objectives, the present invention is implemented by the following technical scheme: a Chinese medicine compound preparation based on the IR model signal pathway, wherein the Chinese medicine compound preparation comprises the following components in parts by weight:

[0007] Coptis chinensis: 15%-25%;

[0008] Rhubarb: 10%-15%;

[0009] Mulberry leaves: 15%-20%;

[0010] Pueraria root: 20%-30%;

[0011] Bitter melon: 10%-15%;

[0012] Ginger: 5%-10%;

[0013] Cinnamon: 5%-10%;

[0014] Licorice: 5%~10%.

[0015] Preferably, the Chinese medicine compound preparation regulates the IRS-GSK3β-GLUT4 signaling pathway to improve insulin resistance through a specific mechanism, including:

[0016] Inhibit the activity of GSK3β, thereby reducing the insulin resistance events caused by GSK3β-mediated reduction of glycogen synthesis;

[0017] Increase the amount of GLUT4 on the cell membrane to promote the intracellular uptake of glucose.

[0018] The preparation method of the Chinese medicine compound preparation comprises the following steps:

[0019] Wash the herbs, remove impurities and soak them in distilled water;

[0020] The soaked medicinal materials were decocted twice, the first decoction time was 30 minutes, and the second decoction time was 30 minutes, and the filtrates obtained from the two decoctions were combined;

[0021] The combined filtrate was concentrated under vacuum to obtain a concentrated solution with a relative density of 1.2;

[0022] The concentrate was made into dry powder by spray drying and freeze drying;

[0023] Grind the dry powder into fine powder and mix well;

[0024] The uniformly mixed powder is prepared into tablets, capsules, water pills, concentrated pills and oral liquid as required.

[0025] Preferably, the medicinal material soaking comprises:

[0026] Mixing the coptis root, rhubarb, mulberry leaf, kudzu root, bitter melon, ginger, cinnamon bark and liquorice according to a predetermined ratio;

[0027] Add eight times the total weight of the herbs to the mixed herbs with distilled water;

[0028] The soaking time is controlled at 30 minutes to ensure the full release of the active ingredients in the medicinal materials.

[0029] Preferably, the decocting process comprises:

[0030] First decoction: Soak the herbs and boil over high heat, then switch to low heat and keep boiling for 30 minutes, and filter to obtain the first filtrate;

[0031] Second decoction: add distilled water equal to the first decoction to the medicinal material residue, decoct again for 30 minutes, and filter to obtain the second filtrate;

[0032] Combine the filtrates obtained from the two decoctions, cool and set aside.

[0033] Preferably, vacuum concentration comprises:

[0034] Vacuum concentration is performed under the condition of temperature control at 40℃~60℃ to avoid damage to the active ingredients of the drug by high temperature;

[0035] Concentrate to 1 / 10 of the original liquid volume to ensure that the drug extract has an appropriate concentration for subsequent drying treatment.

[0036] Preferably, spray drying comprises:

[0037] The concentrated medicinal material extract is sprayed out through a high-pressure spray head to form fine droplets to improve drying efficiency;

[0038] The drying temperature does not exceed 60°C and the drying process is carried out under low humidity conditions to ensure the quality and stability of the dried product.

[0039] Preferably, tablet preparation comprises:

[0040] The uniformly mixed drug powder is mixed with an appropriate amount of auxiliary materials, wherein the auxiliary materials are selected from crystalline cellulose;

[0041] The mixed powder is made into tablets by a tablet press.

[0042] Preferably, the capsule preparation steps include:

[0043] Fill the evenly mixed powder into empty capsule shells;

[0044] The capsule shell is made of gelatin or plant fiber.

[0045] Preferably, the preparation steps of the oral liquid, water pills and concentrated pills include:

[0046] Oral solution: Dissolve the mixed powder in purified water or other suitable solvents, stir evenly, add appropriate amount of preservatives and sweeteners, and dispense the oral solution into bottles and seal them;

[0047] Water pills: Mix the Chinese medicinal materials according to the proportion and grind them into fine powder; mix the powder with the binder until it has appropriate viscosity; form small spherical pills with a diameter of 3mm to 8mm; dry naturally in a cool place or use low-temperature drying equipment; sieve to ensure the consistency of pill size; seal the package and store in a dry and cool place;

[0048] Concentrated pills: decoct the medicinal materials and perform vacuum concentration to obtain a high-concentration extract;

[0049] The extract is heated and the solid carrier and auxiliary materials are slowly added to form a thick slurry;

[0050] Made into spherical concentrated pills with a diameter of 5mm to 10mm;

[0051] The concentrated pellets are thoroughly dried by low temperature drying;

[0052] Surface lubrication treatment, such as using talcum powder to prevent adhesion;

[0053] Seal the package and store in a dry, cool environment.

[0054] The present invention provides a Chinese medicine compound preparation based on IR model signal pathway and a preparation method thereof. It has the following beneficial effects:

[0055] 1. The present invention significantly reduces blood sugar and insulin levels by regulating the IRS / PI3K / Akt / GLUT4 signaling pathway. In addition, it enhances the sensitivity of hepatocytes to insulin and improves the intracellular uptake of glucose, which provides a more effective treatment option for the management of type 2 diabetes.

[0056] 2. The present invention activates the IRS / PI3K / Akt signaling pathway through the synergistic effect of multiple ingredients, inhibits the activity of GSK3β, and promotes intracellular glucose metabolism. This mechanism effectively alleviates insulin resistance and enhances the sensitivity of liver cells to insulin, which helps long-term blood sugar control.

[0057] 3. The Chinese medicine composite preparation of the present invention not only exerts its effect on a single signal pathway, but also realizes comprehensive regulation by adjusting multiple metabolic pathways. Its multi-target mechanism of action has a significant promoting effect on sugar metabolism, insulin sensitivity, cellular glucose uptake, etc., showing excellent therapeutic effect and broad application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] Figure 1 It is a preparation flow chart of the present invention. DETAILED DESCRIPTION

[0059] The following will be combined with the drawings in the specification of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0060] Please see attached Figure 1 The embodiment of the present invention provides a Chinese medicine compound preparation based on the IR model signal pathway, and the Chinese medicine compound preparation includes the following components in parts by weight:

[0061] Coptis chinensis: 15% to 25%. Berberine can inhibit GSK3β, promote the phosphorylation of GSK3β, help reduce the degradation of insulin receptor substrates, stabilize insulin signal transmission, and improve insulin resistance.

[0062] Rhubarb: 10% to 15%. It has significant anti-inflammatory and antioxidant effects. Rhubarb improves insulin signaling by regulating antioxidant responses and alleviating oxidative stress. In addition, the active ingredients in rhubarb can directly inhibit the activity of GSK3β and promote glycogen synthesis, further enhancing the efficiency of insulin signaling and improving insulin sensitivity.

[0063] Mulberry leaves: 15% to 20%. The flavonoids in mulberry leaves can increase the expression of GLUT4 transporter and promote its translocation in the cell membrane, thus accelerating the absorption and utilization of glucose by cells, thereby lowering blood sugar levels.

[0064] Pueraria root: 20% to 30%. The isoflavone components of Pueraria root can increase the activity of PI3K and Akt. This process is achieved by enhancing insulin signals, further promoting glycogen synthesis and glucose utilization, thereby improving insulin resistance.

[0065] Bitter melon: 10% to 15%. The active ingredients in bitter melon can activate the PI3K / Akt signaling pathway, enhance the sensitivity of liver cells to insulin, promote insulin-mediated sugar metabolism and glycogen synthesis, and have a significant effect on regulating blood sugar;

[0066] Ginger: 5% to 10%. The gingerol compounds in ginger have anti-inflammatory, antioxidant and blood sugar-lowering effects, thereby improving insulin resistance and promoting glucose utilization;

[0067] Cinnamon: 5% to 10%. The active ingredients in cinnamon can mimic the effects of insulin, increase glucose uptake, and activate related signaling pathways, such as the translocation of GLUT4 to the cell membrane, thereby increasing the responsiveness of cells to insulin.

[0068] Licorice: 5%-10%. Licorice can regulate blood sugar by enhancing insulin signaling and improving insulin resistance. At the same time, the anti-inflammatory effect of licorice can also help alleviate the chronic inflammatory state common in patients with type 2 diabetes.

[0069] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, the Chinese medicine compound preparation regulates the IRS-GSK3β-GLUT4 signaling pathway through a specific mechanism to improve insulin resistance, including:

[0070] Inhibit the activity of GSK3β, thereby reducing insulin resistance events caused by reduced glycogen synthesis mediated by GSK3β. The compounds contained in coptis root, rhubarb, and bitter melon in the Chinese medicine compound preparation can directly or indirectly inhibit the activity of GSK3β, promote GSK3β phosphorylation, thereby increasing glycogen synthesis and improving insulin sensitivity. The compound preparation enhances the transmission efficiency of insulin signals and improves the state of insulin resistance. This effect helps to stabilize insulin-mediated sugar metabolism and energy balance in cells, providing a significant improvement in blood sugar control for patients with type 2 diabetes.

[0071] Increase the amount of GLUT4 on the cell membrane to promote the intracellular uptake of glucose. Mulberry leaves and kudzu root in the Chinese medicine compound preparation increase the intracellular uptake rate of glucose by enhancing the expression of GLUT4 transporter and its translocation to the cell membrane. This mechanism of action directly promotes the cell's utilization of blood glucose, thereby helping to lower blood glucose levels and improve insulin sensitivity. In addition, increasing the cell membrane expression of GLUT4 also helps maintain the balance of glucose inside and outside the cell, thereby preventing cytotoxicity and tissue damage caused by high blood sugar.

[0072] The present invention also provides a method for preparing a Chinese medicine composite preparation, comprising the following steps:

[0073] The medicinal materials are cleaned, impurities are removed and then soaked in distilled water. This step is to ensure that the preparation does not contain any foreign contaminants, thereby ensuring the purity and safety of the final product;

[0074] The soaked medicinal materials are decocted twice, the first decoction time is 30 minutes, and the second decoction time is 30 minutes. The filtrates obtained from the two decoctions are combined. The first decoction extracts most of the water-soluble active ingredients, and the second decoction is intended to further extract the residual active ingredients from the partially exhausted medicinal materials. The filtrates obtained from the two decoctions are then combined. This can maximize the utilization rate of the medicinal materials and increase the concentration of the extract.

[0075] The combined filtrate is vacuum concentrated to obtain a concentrated solution with a relative density of 1.2. The combined filtrate is reduced in volume by vacuum concentration technology to reach a predetermined relative density of 1.2. The vacuum concentration is performed at a relatively low temperature to avoid damage to sensitive components in the medicinal materials caused by high temperature, thereby ensuring the integrity and activity of the active components;

[0076] The concentrate is made into dry powder by spray drying and freeze drying. Spray drying is to atomize the liquid into tiny droplets by high-pressure spray, and then quickly dry in hot air, so that dry powder can be obtained quickly and the loss of heat-sensitive components can be reduced. Freeze drying is drying at low temperature, which is suitable for extremely sensitive components;

[0077] The dried powder is ground into fine powder and mixed evenly, and the dried powder is ground into a finer powder for subsequent processing into different dosage forms;

[0078] As needed, the evenly mixed powder is prepared into tablets, capsules, water pills, concentrated pills and oral liquids. Tablets and capsules are convenient for accurate dosage and easy to carry and use, while oral liquids are suitable for patients with dysphagia or who require quick effects, thus ensuring the diversity and applicability of Chinese medicine compound preparations to meet the needs of different patients.

[0079] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, the medicinal material soaking comprises:

[0080] Mix coptis root, rhubarb, mulberry leaf, kudzu root, bitter melon, ginger, cinnamon bark and licorice in a predetermined ratio. Mixing medicinal materials can promote the interaction between the components and help improve the extraction efficiency.

[0081] Add eight times the total weight of distilled water to the mixed herbs. Distilled water is chosen to prevent impurities in the water from affecting the quality and safety of the herbs. The amount of water is sufficient to cover all the herbs, ensuring that each ingredient can be evenly exposed to the water, thereby maximizing the release of active ingredients.

[0082] The soaking time is controlled at 30 minutes to ensure the full release of the effective ingredients in the medicinal materials. This time setting is sufficient to allow the water-soluble components in the medicinal materials to fully dissolve. Short-term soaking also helps to maintain the freshness and activity of the medicinal materials.

[0083] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, the decocting process comprises:

[0084] First decoction: Soak the herbs and boil them over high heat, then switch to low heat and keep boiling for 30 minutes. Filter to get the first filtrate. Boil the soaked herbs quickly over high heat. The purpose of this step is to quickly destroy the structure of plant cells and release water-soluble and some volatile components. After reaching the boiling point, switch to low heat and continue to boil for 30 minutes. Keep boiling without over-boiling. This helps more active ingredients to be gently extracted and avoids the decomposition of ingredients caused by high temperature.

[0085] Second decoction: add the same amount of distilled water as the first decoction to the medicinal material residue, decoct again for 30 minutes, and filter to obtain the second filtrate. This decoction is intended to further extract the remaining active ingredients from the medicinal materials, especially those that are difficult to be completely released in the first decoction. The decoction time is also maintained at 30 minutes and carried out at a lower temperature to protect sensitive ingredients from being destroyed;

[0086] The filtrates obtained from the two decoctions are combined, cooled and set aside. This step not only increases the concentration of the medicine, but also ensures that all available medicinal ingredients in the medicinal materials are effectively utilized. The combined filtrate is cooled and set aside in preparation for the subsequent concentration and drying steps.

[0087] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, vacuum concentration comprises:

[0088] Vacuum concentration is performed at a temperature controlled between 40°C and 60°C to avoid damage to the active ingredients of the drug by high temperature. This temperature range reduces the thermal degradation of heat-sensitive ingredients while increasing the solubility and evaporation efficiency of volatile substances. Low-temperature vacuum concentration helps protect volatile oils and heat-labile compounds in medicinal materials, which are usually key active ingredients that provide therapeutic effects.

[0089] Concentrate to 1 / 10 of the original liquid volume to ensure that the concentration of the drug extract is appropriate for subsequent drying treatment. This ratio is chosen to ensure that the active ingredients in the extract reach a sufficient concentration so that they can be effectively converted into powder form during the subsequent drying process, while avoiding precipitation or inactivation of ingredients caused by excessive concentration. This degree of concentration balances the stability of the ingredients and the extraction efficiency.

[0090] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, spray drying comprises:

[0091] The concentrated medicinal material extract is sprayed out through a high-pressure spray nozzle to form fine droplets to improve drying efficiency. The evaporation of water is accelerated by increasing the surface area of ​​the droplets, thereby drying quickly. The fine droplets can achieve more uniform drying and avoid local overheating, ensuring the uniformity and activity of the drug components.

[0092] The drying temperature does not exceed 60°C and the drying process is carried out under low humidity conditions to ensure the quality and stability of the dried product. Drying under low humidity conditions helps to quickly remove moisture and avoid component degradation or microbial contamination caused by excessive humidity. This step not only improves the drying efficiency, but also maintains the integrity of the bioactive ingredients in the medicinal materials.

[0093] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, tablet preparation comprises:

[0094] The uniformly mixed drug powder is mixed with a proper amount of excipients, and the excipients are selected from microcrystalline cellulose. First, the finely ground drug material is mixed with a proper amount of excipients. These excipients not only help to increase the compressibility and mechanical strength of the tablets, but also improve the dissolution and absorption rate of the tablets. Microcrystalline cellulose is an excellent binder to ensure that the tablets will not break due to mechanical pressure during the manufacturing process;

[0095] The mixed drug powder is passed through a tablet press to prepare tablets. During this process, the drug powder is evenly filled into a mold and then compressed into tablets of fixed shape and size using high pressure.

[0096] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, the capsule preparation step comprises:

[0097] The mixed powder is put into the empty capsule shell. First, the medicinal materials ground into fine powder are mixed evenly and then put into the empty capsule shell;

[0098] The capsule shell is made of gelatin or plant fiber. Gelatin capsules are made from animal gelatin extracts and are widely used in medicines and health supplements. They have good biocompatibility and digestion and absorption properties. Plant fiber capsule shells provide an option for vegetarians or consumers who are sensitive to animal products. These capsule shells can also effectively protect the drug ingredients from damage by light and oxygen, thereby enhancing the patient's acceptance and convenience of treatment, thereby promoting better treatment effects and higher compliance.

[0099] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, the steps of preparing the oral liquid, water pills and concentrated pills include:

[0100] Oral liquid: Oral liquid is made by dissolving the mixed powder in purified water or other suitable solvents, stirring evenly, adding appropriate amount of preservatives and sweeteners, and packaging the oral liquid into bottles and sealing them. The ground medicinal materials are uniformly dissolved in purified water or other suitable solvents, and efficient stirring equipment is used to ensure that the powder is completely dissolved to form a uniform liquid medicine. Appropriate amount of preservatives and sweeteners are added, and the oral liquid is packaged into bottles and sealed. In order to maintain the stability of the liquid medicine and improve the taste, appropriate amount of preservatives and sweeteners are added. Preservatives such as sodium benzoate or potassium sorbate help extend the shelf life of the liquid medicine and prevent the growth of microorganisms; sweeteners such as sodium saccharin or licorice extract are used to improve the taste of the liquid medicine and make it easier for patients to accept. Finally, the sealed bottle ensures that the liquid medicine is not contaminated by the outside world and keeps it pure and safe.

[0101] Water pills: Mix the Chinese medicinal materials according to the proportion and grind them into fine powder; mix the powder with the binder until it has appropriate viscosity; form small spherical pills with a diameter of 3mm to 8mm; dry naturally in a cool place or use low-temperature drying equipment; sieve to ensure the consistency of pill size; seal the package and store in a dry and cool place;

[0102] Concentrated pills: decoct the medicinal materials and perform vacuum concentration to obtain a high-concentration extract;

[0103] The extract is heated and the solid carrier and auxiliary materials are slowly added to form a thick slurry;

[0104] Made into spherical concentrated pills with a diameter of 5mm to 10mm;

[0105] The concentrated pellets are thoroughly dried by low temperature drying;

[0106] Surface lubrication treatment, such as using talcum powder to prevent adhesion;

[0107] Seal the package and store in a dry, cool environment.

[0108] In order to better understand the present invention, the above contents are described in detail below in conjunction with specific embodiments.

[0109] Example 1: Tablet form of Chinese medicine compound preparation

[0110] Formula: Coptis chinensis 20%, rhubarb 12%, mulberry leaf 17%, kudzu root 25%, bitter melon 11%, ginger 5%, cinnamon 5%, licorice 5%.

[0111] Preparation method:

[0112] Mix all the herbs in proportion and grind them into fine powder.

[0113] The drug powder is mixed with an appropriate amount of microcrystalline cellulose, which is used as an excipient to improve the binding and stability of the tablets.

[0114] The mixed powder is compressed into tablets by tablet pressing machine.

[0115] Uses: Suitable for assisting in improving insulin sensitivity and blood sugar control in patients with chronic type 2 diabetes.

[0116] Example 2: Capsule form of Chinese medicine compound preparation

[0117] Formula: Coptis chinensis 22%, rhubarb 14%, mulberry leaf 15%, kudzu root 20%, bitter melon 12%, ginger 6%, cinnamon 6%, licorice 5%.

[0118] Preparation method:

[0119] All the medicinal materials are mixed according to the above proportions and ground into powder.

[0120] The powder is filled into gelatin or vegetable fiber capsule shells.

[0121] Uses: Capsules are suitable for situations where it is necessary to control the drug release rate or improve drug stability.

[0122] Example 3: Oral liquid form of Chinese medicine compound preparation

[0123] Formula: Coptis chinensis 18%, rhubarb 10%, mulberry leaf 15%, kudzu root 30%, bitter melon 12%, ginger 5%, cinnamon 5%, licorice 5%.

[0124] Preparation method:

[0125] Mix all the herbs in proportion and boil them with distilled water.

[0126] The decoction was filtered to remove the residue and then concentrated in vacuo.

[0127] The concentrated liquid is added with appropriate amount of sweetener and preservative to prepare an oral liquid.

[0128] Uses: Oral liquid form is suitable for children or elderly patients with dysphagia and is easy to take.

[0129] Comparative experiment 1: Pharmacodynamic evaluation experimental test

[0130] Experimental purpose: To evaluate the effect of the Chinese medicine composite preparation of the present invention on Wistar rats with type 2 diabetes, including blood sugar level, insulin sensitivity and other indicators, in order to prove its potential effect on improving the condition of type 2 diabetes.

[0131] Experimental setup:

[0132] Animal selection: Healthy adult male Wistar rats were selected.

[0133] Grouping: The mice were randomly divided into 4 groups, with 10 mice in each group.

[0134] Normal control group: normal feed.

[0135] Negative control group: type 2 diabetes model.

[0136] Experimental group A: type 2 diabetes model + medium-dose Chinese medicine compound preparation.

[0137] Positive control group: type 2 diabetes model + drugs with known effects (metformin).

[0138] Experimental procedures

[0139] Modeling method: After 4 weeks of high-fat diet, the rats were fasted but not watered for 12 hours and given a single intraperitoneal injection of streptozotocin (STZ) 35 mg / kg. Blood was collected from the tail vein 3 days later to measure blood glucose, and blood glucose ≥16.7 mmol / L was used as the modeling standard.

[0140] Experimental period: The experiment lasted for 8 weeks.

[0141] Data Recording: Measure and record your weight and blood sugar levels regularly.

[0142] Sample Collection: At the end of the experiment, blood samples were collected to measure insulin levels.

[0143] Statistical analysis: All data were statistically analyzed by ANOVA test.

[0144] The comparative experimental data are shown in Table 1:

[0145] Table 1 Physiological indicators at the end of the experiment

[0146] Group Weight (g) Blood glucose level (mmol / L) Insulin level (μU / ml) Normal control group 233.56±8.15 5.67±0.88 19.52±1.68 Negative control group 288.56±10.42* 21.59±0.58** 28.04±2.63** Experimental Group A 268.45±18.57# 9.93±1.26## 22.25±2.41## Positive control group 273.32±15.84# 10.36±1.01## 23.63±1.82##

[0147] From the data in Table 1, we can get:

[0148] The blood glucose and insulin levels of rats in experimental group A decreased significantly. Compared with the negative control group, the blood glucose level of rats in experimental group A decreased by 54.01%, and the insulin level also decreased by 20.65%, proving the effectiveness of the Chinese herbal compound preparation. In addition, compared with the positive control group (metformin-treated rats), the blood glucose level of experimental group A further decreased by 4.15%, and the insulin level also decreased by 5.84%. These results clearly show the effect of the Chinese herbal compound preparation in improving insulin resistance and lowering blood glucose levels;

[0149] * indicates P<0.05 compared with the normal control group; ** indicates P<0.01 compared with the normal control group; # indicates P<0.05 compared with the negative control group; ## indicates P<0.01 compared with the negative control group. P<0.05 indicates statistical significance, and ANOVA test was used for analysis.

[0150] Comparative experiment 2: Cell-level mechanism research test

[0151] Experimental purpose: To study the effect of Chinese medicine compound preparation on insulin signaling pathway at cellular level.

[0152] Experimental setup and steps

[0153] Cell culture and treatment:

[0154] The human hepatocyte cell line HepG2 was used and divided into three groups:

[0155] control group (untreated);

[0156] negative control group (high glucose treatment);

[0157] Experimental group (high sugar + Chinese medicine compound preparation treatment).

[0158] The cells were cultured in DMEM containing 10% FBS to 70% confluency and then treated for 48 h according to the groups.

[0159] Protein expression analysis:

[0160] Western blot method was used to detect the protein expression levels of IRS-1, IRS-2, Akt, GSK3β, p-GSK3β, and GLUT4 in cells.

[0161] Statistical analysis: All data were statistically analyzed by ANOVA test.

[0162] The comparative experimental data are shown in Table 2:

[0163] Table 2 Expression of insulin signaling pathway proteins at the cellular level

[0164]

[0165] From the data in Table 2, we can get:

[0166] In the experimental group, the Chinese medicine compound preparation significantly increased the expression of IRS-1, IRS-2, PI3K, Akt, p-GSK3β, and GLUT4, while reducing the expression of GSK3β. This is consistent with the normal activation state of insulin signaling, indicating that the compound preparation can effectively combat insulin resistance caused by a high-sugar environment;

[0167] * indicates P<0.05 compared with the control group; ** indicates P<0.01 compared with the normal control group; # indicates P<0.05 compared with the negative control group; ## indicates P<0.01 compared with the negative control group. P<0.05 indicates statistical significance, and ANOVA test was used for analysis.

[0168] Comparative experiment 3: Long-term animal model efficacy test

[0169] Experimental purpose: To evaluate the effect of Chinese herbal compound preparations on improving insulin resistance in animal models, and to observe the safety and sustainability of long-term administration.

[0170] Experimental setup

[0171] Animal selection: Forty male Wistar rats of similar age and weight were used.

[0172] Grouping: The animals were randomly divided into 4 groups, with 10 animals in each group.

[0173] Normal control group: normal feed.

[0174] Type 2 diabetes model group: type 2 diabetes model.

[0175] Experimental group 1: type 2 diabetes model + low-dose Chinese medicine compound preparation.

[0176] Experimental group 2: type 2 diabetes model + high-dose Chinese medicine compound preparation.

[0177] Experimental period: The experiment lasted for 12 weeks.

[0178] Experimental procedures

[0179] The experimental group was given the Chinese herbal compound preparation once a day for 12 weeks.

[0180] Keep a regular log of your weight, blood sugar, and insulin levels.

[0181] After the experiment, blood and tissue samples were collected for biochemical analysis.

[0182] Statistical analysis: All data were analyzed by ANOVA and Tukey post hoc test.

[0183] The comparative experimental data are shown in Table 3:

[0184] Table 3 Long-term animal model efficacy test data

[0185]

[0186]

[0187] From the data in Table 3, we can get:

[0188] The blood glucose level in the type 2 diabetes model group increased from 18.87±0.81mmol / L to 22.26±1.35mmol / L, and the insulin level increased from 27.63±3.03μIU / mL to 28.83±1.05μIU / mL, which clearly demonstrated the model characteristics of disease progression. In contrast, the blood glucose level in experimental group 1 decreased from 18.32±1.07mmol / L to 11.06±1.41mmol / L, and the insulin level also decreased from 28.03±1.84μIU / mL to 24.17±2.18μIU / mL. The blood glucose level in experimental group 2 decreased from 19.0±1.16mmol / L to 9.18±1.16mmol / L, and the insulin level also decreased from 27.93±1.67μIU / mL to 22.57±1.59μIU / mL, showing the therapeutic effect of the Chinese medicine compound preparation;

[0189] * indicates P<0.05 compared with the normal control group; ** indicates P<0.01 compared with the normal control group; # indicates P<0.05 compared with the negative control group; ## indicates P<0.01 compared with the negative control group. P<0.05 indicates statistical significance, and ANOVA and Tukey post hoc test were used for analysis.

[0190] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine compound preparation based on IR model signal pathway, characterized in that: The Chinese medicine composite preparation comprises the following components in parts by weight: Coptis chinensis: 15%-25%; Rhubarb: 10%-15%; Mulberry leaves: 15%-20%; Pueraria root: 20%-30%; Bitter melon: 10%-15%; Ginger: 5%-10%; Cinnamon: 5%-10%; Licorice: 5%~10%.

2. The Chinese medicine compound preparation based on the IR model signal pathway according to claim 1, characterized in that: The Chinese medicine compound preparation regulates the IRS-GSK3β-GLUT4 signaling pathway through a specific mechanism to improve insulin resistance, including: Inhibit the activity of GSK3β, thereby reducing the insulin resistance events caused by GSK3β-mediated reduction of glycogen synthesis; Increase the amount of GLUT4 on the cell membrane to promote the intracellular uptake of glucose.

3. A method for preparing a Chinese medicine composite preparation, characterized in that: Using the Chinese medicine compound preparation based on the IR model signal pathway according to any one of claims 1-2 comprises the following steps: Wash the herbs, remove impurities and soak them in distilled water; The soaked medicinal materials were decocted twice, the first decoction time was 30 minutes, and the second decoction time was 30 minutes, and the filtrates obtained from the two decoctions were combined; The combined filtrate was concentrated under vacuum to obtain a concentrated solution with a relative density of 1.2; The concentrate was made into dry powder by spray drying and freeze drying; Grind the dry powder into fine powder and mix well; The uniformly mixed powder is prepared into tablets, capsules, water pills, concentrated pills and oral liquid as required.

4. The method for preparing the Chinese medicine composite preparation according to claim 1, characterized in that: Herbal soaking includes: Mixing the coptis root, rhubarb, mulberry leaf, kudzu root, bitter melon, ginger, cinnamon bark and liquorice according to a predetermined ratio; Add eight times the total weight of the herbs to the mixed herbs with distilled water; The soaking time is controlled at 30 minutes to ensure the full release of the active ingredients in the medicinal materials.

5. The method for preparing the Chinese medicine composite preparation according to claim 1, characterized in that: The decoction process includes: First decoction: Soak the herbs and boil over high heat, then switch to low heat and keep boiling for 30 minutes, and filter to obtain the first filtrate; Second decoction: add distilled water equal to the first decoction to the medicinal material residue, decoct again for 30 minutes, and filter to obtain the second filtrate; Combine the filtrates obtained from the two decoctions, cool and set aside.

6. The method for preparing the Chinese medicine composite preparation according to claim 1, characterized in that: Vacuum concentration includes: Vacuum concentration is performed under the condition of temperature control at 40℃~60℃ to avoid damage to the active ingredients of the drug by high temperature; Concentrate to 1 / 10 of the original liquid volume to ensure that the drug extract has an appropriate concentration for subsequent drying treatment.

7. The method for preparing the Chinese medicine composite preparation according to claim 1, characterized in that: Spray drying includes: The concentrated medicinal material extract is sprayed out through a high-pressure spray head to form fine droplets to improve drying efficiency; The drying temperature does not exceed 60°C and the drying process is carried out under low humidity conditions to ensure the quality and stability of the dried product.

8. The method for preparing the Chinese medicine composite preparation according to claim 1, characterized in that: Tablet preparation includes: The uniformly mixed drug powder is mixed with an appropriate amount of auxiliary materials, wherein the auxiliary materials are selected from microcrystalline cellulose; The mixed powder is made into tablets by a tablet press.

9. The method for preparing the Chinese medicine composite preparation according to claim 1, characterized in that: The capsule preparation steps include: Fill the evenly mixed powder into empty capsule shells; The capsule shell is made of gelatin or plant fiber.

10. The method for preparing the Chinese medicine composite preparation according to claim 1, characterized in that: The preparation steps of oral solution, water pills and concentrated pills include: Oral solution: Dissolve the mixed powder in purified water or other suitable solvents, stir evenly, add appropriate amount of preservatives and sweeteners, and dispense the oral solution into bottles and seal them; Water pills: Mix the Chinese medicinal materials in proportion and grind them into fine powder; mix the powder with the binder until it has appropriate viscosity; form small spherical pills with a diameter of 3mm to 8mm; dry naturally in a cool place or use low-temperature drying equipment; sieve to ensure the consistency of pill size; seal the package and store in a dry and cool place; Concentrated pills: decoct the medicinal materials and perform vacuum concentration to obtain a high-concentration extract; The extract is heated and the solid carrier and auxiliary materials are slowly added to form a thick slurry; Made into spherical concentrated pills with a diameter of 5mm to 10mm; The concentrated pellets are thoroughly dried by low temperature drying; Surface lubrication treatment, such as using talcum powder to prevent adhesion; Seal the package and store in a dry, cool environment.

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