Radix puerariae and pseudo-ginseng tablet for preventing diabetes atherosclerosis as well as preparation method and application thereof

Abstract

The invention discloses a kudzuvine root and pseudo-ginseng tablet for preventing diabetes atherosclerosis and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine, the kudzuvine root medicinal material is taken, impurities and non-medicinal parts are removed, and the kudzuvine root medicinal material is crushed into coarse powder; taking main roots or fibrous roots of pseudo-ginseng, cleaning, drying and crushing into coarse powder; mixing the pseudo-ginseng and radix puerariae coarse powder, adding into an ethanol solution, and heating and refluxing; performing reflux extraction for three times, filtering medicine residues after each time of extraction, and then adding an ethanol solution for reflux extraction; combining the three extracting solutions, filtering and concentrating to obtain thick paste, and drying to obtain the radix puerariae and pseudo-ginseng extract. And mixing the kudzuvine root and pseudo-ginseng extract with auxiliary materials, preparing a soft material, granulating, drying, granulating, totally mixing and tabletting to obtain the kudzuvine root and pseudo-ginseng tablet. The radix puerariae and pseudo-ginseng extract is applied to preparation of drugs or health products for preventing and / or treating diabetes atherosclerosis. The radix notoginseng and radix puerariae extract can cover a plurality of pathological links of diabetes atherosclerosis, and the defect that the action target of a single component is limited is overcome.

Description

A kudzu root and Panax notoginseng tablet for the prevention of diabetic atherosclerosis, its preparation method and application Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a kudzu root and Panax notoginseng tablet for the prevention of diabetic atherosclerosis, its preparation method, and its application. Background Technology

[0002] Atherosclerosis (AS) is the most common cardiovascular disease, characterized by the formation of fibrous or atherosclerotic plaques in the vascular endothelium. It can affect large and medium-sized arteries, leading to hardening of the vessel walls and narrowing of the lumen, which in turn can cause serious complications such as cerebrovascular infarction, limb gangrene, and even death. Diabetic atherosclerosis, as the most significant macrovascular complication of diabetes, is showing an increasing incidence rate, and its progression is significantly faster than in non-diabetic patients. It is the leading cause of cardiovascular-related death in diabetic patients.

[0003] Currently, the core pathological mechanism of diabetic atherosclerosis involves multiple aspects, including hyperglycemia-mediated vascular endothelial damage, lipid metabolism disorders, oxidative stress, and inflammatory responses. Under hyperglycemic conditions, a large amount of reactive oxygen species are generated, triggering oxidative stress that damages the vascular endothelium. Simultaneously, it leads to elevated levels of triglycerides (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C), causing lipid deposition in the vascular endothelium and plaque formation. Inflammatory responses further exacerbate endothelial dysfunction, promoting plaque progression and instability. Clinical prevention and treatment strategies for this disease mainly focus on controlling risk factors such as hyperglycemia, hyperlipidemia, and hypertension. Commonly used drugs include statins, PCSK9 inhibitors, and sodium-glucose cotransporter 2 (SGLT2) inhibitors.

[0004] However, existing treatments still have significant limitations. Various chemical drugs primarily target single pathological processes, failing to comprehensively cover the complex pathological processes involving multiple targets and pathways. Furthermore, some drugs have adverse reactions or are limited to specific populations. Therefore, developing an intervention program that balances prevention and treatment, achieves synergistic effects across multiple targets, and offers greater safety is of significant clinical importance for improving the prognosis of patients with diabetic atherosclerosis.

[0005] Traditional Chinese medicine (TCM) possesses unique advantages in the prevention and treatment of chronic diseases due to its multi-component and multi-target effects. Kudzu root, a traditional Chinese medicinal herb, has the functions of promoting body fluid production, quenching thirst, and clearing the meridians; Panax notoginseng has the effects of removing blood stasis, stopping bleeding, and relieving pain. The combination of these two herbs perfectly aligns with the core pathogenesis of diabetic atherosclerosis—"deficiency of both qi and yin, and obstruction of blood stasis." However, current systematic research on the use of kudzu root and Panax notoginseng powder for the prevention and treatment of diabetic atherosclerosis, as well as the development of related products, are still incomplete. Standardized and scalable intervention programs have not yet been established, making it difficult to meet actual clinical needs. Based on this, this invention proposes a kudzu root and Panax notoginseng extract and its preparation, as well as its application in the prevention and treatment of diabetic atherosclerosis, to fill the existing technological gap. Summary of the Invention

[0006] To achieve the above objectives, this application provides a method for preparing a Pueraria lobata extract, and a method for preparing Pueraria lobata tablets using the Pueraria lobata extract. The Pueraria lobata extract can be used to prepare related pharmaceuticals or health products for the prevention and / or treatment of diabetic atherosclerosis.

[0007] The first objective of this invention is to provide a method for preparing Pueraria lobata and Panax notoginseng tablets for the prevention of diabetic atherosclerosis, comprising the following steps: Step S1, taking Pueraria lobata, removing impurities and non-medicinal parts, and pulverizing into coarse powder; Step S2, taking the main root or fibrous roots of Panax notoginseng, washing, drying, and pulverizing into coarse powder; Step S3, mixing Panax notoginseng and Pueraria lobata coarse powder and adding to an ethanol solution, heating under reflux; Step S4, reflux extraction three times, filtering the residue after each extraction, and then adding ethanol solution for further reflux extraction; Step S5, combining the three extracts, filtering and concentrating to obtain a thick paste, and drying to obtain Pueraria lobata and Panax notoginseng extract.

[0008] In the preparation method described above, in step S3, the mass ratio of kudzu root to Panax notoginseng is 2:1, and the mixture is passed through a 20-50 mesh sieve.

[0009] In the preparation method described above, the concentration of the ethanol solution is 50%-70%, and the mass-volume ratio of the total amount of Panax notoginseng powder and Pueraria lobata powder to the amount of ethanol solution is 1:6-8 kg / L.

[0010] As described above, the preparation method involves soaking the sample before the first extraction and then heating and refluxing for 60-90 minutes each time.

[0011] In the preparation method described above, the vacuum concentration temperature in step S5 is 50-60℃, and the viscous paste is dried in an oven at 70-80℃.

[0012] Another objective of this invention is to provide a dosage form of Pueraria lobata extract, which can be combined with suitable pharmaceutical excipients to prepare different dosage forms.

[0013] A type of Pueraria lobata and Panax notoginseng tablets are prepared by mixing Pueraria lobata and Panax notoginseng extract GS obtained by the above preparation method with excipients, preparing soft material, granulating, drying, sizing, total mixing, and tableting to obtain Pueraria lobata and Panax notoginseng tablets.

[0014] As mentioned above, the filler in the excipients of the Pueraria lobata and Panax notoginseng tablets is selected from one or more of lactose, dextrin, starch, and microcrystalline cellulose. First, a 60-80% ethanol solution is selected as a wetting agent. After the excipients and GS extract are mixed evenly, an appropriate amount of wetting agent is sprayed, the soft material is granulated, and then placed in an oven to dry and granulate.

[0015] As described above, the filler in the Pueraria lobata and Panax notoginseng tablets is starch, and the excipients also include magnesium stearate. The ratio of GS extract to filler is 1:1-3, and the wetting agent is 70% ethanol.

[0016] A third objective of this invention is to provide the use of Pueraria lobata extract in the preparation of a medicament or health product for the prevention and / or treatment of diabetic atherosclerosis.

[0017] As described above, the Pueraria lobata and Panax notoginseng tablets exert their preventive and / or therapeutic effects on diabetic atherosclerosis through one or more mechanisms, including protecting vascular endothelial function, regulating lipid metabolism, and inhibiting inflammatory responses.

[0018] Due to the adoption of the above technical solutions, the technical effects achieved by this invention are as follows: The Pueraria lobata and Panax notoginseng extract of this application combines Pueraria lobata and Panax notoginseng, and its effects can cover multiple pathological links in diabetic atherosclerosis, such as glucose and lipid metabolism disorders, vascular endothelial damage, inflammatory response, and thrombosis, thus overcoming the limitation of single-component drugs with limited target points. Pueraria lobata and Panax notoginseng extract can be used to prepare various dosage forms of drugs or health products for the prevention and / or treatment of diabetic atherosclerosis. For example, this application provides a simple tablet preparation method, and this application uses a zebrafish model of diabetic atherosclerosis to find that Pueraria lobata and Panax notoginseng tablets have a preventive effect on this disease.

[0019] Diabetic atherosclerosis is a chronic disease that requires long-term medication. Both kudzu root and Panax notoginseng are traditional Chinese medicines that can be used as both food and medicine. Moreover, the cooling properties of kudzu root in the formula of this application can neutralize the warming properties of Panax notoginseng, resulting in high safety for long-term use. Attached Figure Description

[0020] Figure 1 shows the standard curve of ginsenoside Re; Figure 2 shows the standard curve of rutin; Figure 3 shows the effect of GS on glucose, cholesterol, and triglyceride levels in a zebrafish model; compared with the Model group, *P<0.05, **P<0.01, ***P<0.001; Figure 4 shows the effect of GS on arterial plaques in a zebrafish model compared to single-herb Panax notoginseng and Pueraria lobata; Figure 5 shows the effect of GS administration on arterial plaques in a zebrafish model; Figure 6 shows the effect of GS administration on arterial width in a zebrafish model; compared with the Model group,*** P < 0.001; Figure 7 shows the effect of GS administration on arterial endothelial cells in a zebrafish model; compared with the Model group, *P < 0.05, ***P < 0.001; Figure 8 shows the effect of GS administration on the inflammatory response in a zebrafish model; compared with the Model group, *P < 0.05, **P < 0.01, ***P < 0.001; Figure 9 shows the effect of GS administration on pancreatic β cells in a zebrafish model; compared with the Model group, *P < 0.05, **P < 0.01, ***P < 0.001. Detailed Implementation

[0021] The technical solution of this application will be described in detail below with reference to specific accompanying drawings and embodiments.

[0022] I. Research on the Preparation Process of Pueraria lobata and Panax notoginseng tablets (GS) 1. Experimental Methods 1.1 Orthogonal Experimental Design of Alcohol Extraction Process The yield of total flavonoids, total saponins, and dry extract were used as indicators for optimizing the extraction process in the GS orthogonal experiment. Four factors with significant extraction influence—ethanol concentration (A), extraction time (B), number of extractions (C), and solvent usage (D)—were considered. The extract yield, total flavonoid content, and total saponin content were used as indicators. First, the importance of these three indicators was assessed using the AHP method, and a priority matrix was established. The matrix was then processed to calculate the weight coefficients of each indicator. Next, the experimental results were standardized using the CRITIC method and imported into SPSS software for analysis. The weight coefficients of each indicator were calculated. Finally, the AHP-CRITIC weighted average method was used to obtain the comprehensive score % = (total saponin content / maximum total saponin content) × 66.81% + (total flavonoid content / maximum total flavonoid content) × 17.00% + (extract yield / maximum extract yield) × 16.19%. The factor levels and experimental arrangements for orthogonal experimental design are shown in Tables 1 and 2.

[0023] Table 1 Factor Table for GS Orthogonal Experiment

[0024] Table 2 GS Orthogonal Experiment Arrangement Table

[0025] 2. Establishment of a method for determining total saponin content 2.1 Preparation of reference solution Accurately weigh 10.17 mg of ginsenoside Re reference standard, add methanol to dissolve and dilute to a standard solution with a concentration of 2.034 mg / mL.

[0026] 2.2 Preparation of the test solution: Accurately weigh 0.250 g of the dry extracts of kudzu root and Panax notoginseng, place them in a 250 mL volumetric flask, add a small amount of water, sonicate for 30 min, then dilute to 250 mL with water, shake well, let stand, accurately pipette 1 mL of the supernatant onto a column (packed with macroporous resin), wash the column with 25 mL of water, discard the eluent, then elute with 25 mL of 70% ethanol, collect the eluent in an evaporating dish and evaporate to dryness in a water bath, dissolve in methanol to obtain the test solution.

[0027] 2.3 Establishment of the Assay Method: After evaporating methanol from the prepared reference solution and test solution in a water bath, add 0.2 mL of 5% vanillin-glacial acetic acid solution to a dry evaporating dish to dissolve the residue. Then add 0.8 mL of perchloric acid, stir, transfer to a stoppered test tube, seal tightly, and heat in a 60℃ water bath for 10 min. Remove and cool to room temperature in an ice-water bath. Finally, add 5 mL of glacial acetic acid and shake well for assay. (Vanillin-Perchloric Acid Colorimetric Method) 2.4 Selection of the Maximum Absorption Wavelength: Take 200 μL of the reference solution and test solution respectively and perform colorimetric development according to the above method. Use methanol solution as a blank control. Place 200 μL of each solution into an ELISA plate and scan in the wavelength range of 400-600 nm using an ELISA reader. Select the common maximum absorption wavelength of the standard solution and test solution for subsequent determination.

[0028] The scanning results showed that the reference standard and the test sample of ginsenoside Re had the maximum absorption wavelength at around 550 nm. Therefore, 550 nm was selected as the absorption wavelength for subsequent determination.

[0029] 2.5 Construction of the Ginsenoside Re Standard Curve: 20, 40, 60, 80, 100, and 120 μL of the prepared ginsenoside Re standard solution were placed in evaporating dishes, and then color development was performed as described above. 200 μL of each solution was then placed in an ELISA plate, and the absorbance was measured using an ELISA reader. The ginsenoside Re concentration was plotted on the x-axis, and the absorbance value on the y-axis to construct the ginsenoside Re standard curve. The regression equation was then calculated.

[0030] The standard curve of ginsenoside Re is shown in Figure 1, and the regression equation for ginsenoside Re was calculated as y = 13.552x + 0.0181 (R²). 2 =0.9971), and showed good linearity in the range of 0.00678–0.04068 mg / mL.

[0031] 2.6 Precision test: Take the prepared ginsenoside Re reference solution, perform color development according to the above method, take 200 μL and place it in the microplate, and use the microplate reader to measure the absorbance value 6 times in a row to detect the precision of the instrument.

[0032] The precision test yielded an RSD value of 0.69%, indicating that the instrument has good precision.

[0033] 2.7 Stability test: Take the prepared solution of the same test sample and perform color development according to the above method. Take 200 μL and place it in an ELISA plate. Use an ELISA reader to measure the absorbance value every 30 min to detect the stability of the test sample within 150 min.

[0034] The stability test yielded an RSD value of 1.8%, indicating that the test sample exhibited good stability within 150 min. 2.8 Repeatability Test: Six aliquots of the prepared same test sample solution were taken and subjected to color development according to the above method. 200 μL of each aliquot was placed in an ELISA plate, and the absorbance value was measured using an ELISA reader to determine the repeatability of the method.

[0035] The repeatability test yielded an RSD value of 0.34%, indicating that the method has good repeatability.

[0036] 2.9 Spiking Recovery Test: Accurately weigh 6 test solutions, add an equal amount of ginsenoside Re reference solution to each, and perform color development according to the above method. Take 200 μL and place it in an ELISA plate. Use an ELISA reader to measure the absorbance value and detect the sample spiking recovery rate.

[0037] Results of the spiking recovery test: The average recovery rate of all samples was 98.63%, and the RSD was 2.8%.

[0038] 2.10 Determination of total saponin content in samples: Accurately weigh 0.25 g of the dry extract obtained from the orthogonal experiment for each sample, and prepare and develop the extract according to the above method. Place 200 μL of each extract into an ELISA plate, measure the absorbance value using an ELISA reader, and calculate the total saponin content.

[0039] The results of the total saponin content determination are shown in Table 3.

[0040] 3. Establishment of a method for determining total flavonoid content 3.1 Preparation of reference solution Accurately weigh 5.00 mg of rutin reference standard, add 50% ethanol to dissolve and dilute to a standard solution with a concentration of 0.20 mg / mL.

[0041] 3.2 Preparation of test solution Take 0.20 g of dried extracts of kudzu root and Panax notoginseng and place them in a 25 mL volumetric flask. Add 50% ethanol and sonicate for 10 min. Then dilute to the mark to obtain the test solution.

[0042] 3.3 Establishment of the Assay Method: Take appropriate amounts of the prepared reference solution and test solution into 10 mL volumetric flasks, add 50% ethanol to 5 mL, then add 0.3 mL of 5% sodium nitrite solution, shake well and let stand for 6 min. Add 0.3 mL of 10% aluminum nitrate solution, shake well and let stand for 6 min. Add 4 mL of 1 mol / L sodium hydroxide solution, dilute to the mark with 50% ethanol, shake well and let stand for 15 min, ready for assay. (Aluminum nitrate colorimetric method) 3.4 Selection of the Maximum Absorption Wavelength: Take 200 μL of each of the reference solution and test solution and perform color development according to the above method, using ethanol solution as a blank control. Place each solution into an ELISA plate and scan using an ELISA reader in the wavelength range of 400-600 nm. Select the common maximum absorption wavelength of the standard solution and test solution for subsequent assays.

[0043] The scanning results showed that the rutin reference standard had a common maximum absorption wavelength of around 510 nm, so 510 nm was selected as the absorption wavelength for subsequent measurements.

[0044] 3.5 Construction of the Rutin Standard Curve: 0, 0.25, 0.5, 1, 2, and 3 mL of the prepared rutin standard solution were placed in 10 mL volumetric flasks. Color development was then performed as described above, with 200 μL of each solution placed in an ELISA plate. The absorbance was measured using an ELISA reader. A rutin standard curve was plotted with rutin concentration on the x-axis and absorbance on the y-axis, and the regression equation was calculated.

[0045] The standard curve for rutin is shown in Figure 2, and the regression equation was calculated as y = 6.4482x + 0.0328 (R²). 2 =0.9998), and showed good linearity in the range of 0.000–0.060 mg / mL.

[0046] 3.6 Precision test: Take the prepared rutin reference solution, perform color development according to the above method, take 200 μL and place it in the microplate, and use the microplate reader to measure the absorbance value 6 times in a row to detect the instrument precision.

[0047] The precision test yielded an RSD value of 0.69%, indicating that the instrument has good precision.

[0048] 3.7 Stability test: Take the prepared solution of the same test sample and perform color development according to the above method. Take 200 μL and place it in an ELISA plate. Use an ELISA reader to measure the absorbance value every 30 min to detect the stability of the test sample within 150 min.

[0049] The stability test yielded an RSD value of 1.72%, indicating that the test sample exhibited good stability within 150 min.

[0050] 3.8 Repeatability Test: Take 6 portions of the prepared same test solution and perform color development according to the above method. Take 200 μL of each portion and place it in an ELISA plate. Use an ELISA reader to measure the absorbance value to detect the repeatability of the method.

[0051] The repeatability test yielded an RSD value of 0.40%, indicating that the method has good repeatability.

[0052] 3.9 Spiking Recovery Test: Accurately weigh 6 portions of the test solution, add an equal amount of rutin reference solution to each, and perform color development according to the above method. Pipette 200 μL into an ELISA plate, measure the absorbance value using an ELISA reader, and detect the sample spiking recovery rate.

[0053] Results of the spiking recovery test: The average recovery rate for each spiking test was 99.66%, and the RSD was 1.9%.

[0054] 3.10 Determination of total flavonoid content in samples: Accurately weigh 0.20 g of the dry extract obtained from 9 orthogonal experiments, prepare and develop the extract according to the above method, pipette 200 μL into an ELISA plate, measure the absorbance value using an ELISA reader, and calculate the total flavonoid content.

[0055] The results of the total flavonoid content determination are shown in Table 3.

[0056] 4. Determination of the yield of the extract: Take 10 mL of the orthogonal experimental extract, and take three portions of each group in parallel. Place them in evaporating dishes that have been dried to constant weight, evaporate to dryness in a water bath, dry in an oven at 105℃ for 3 h, take them out, cool them in a desiccator for 30 min, and quickly and accurately weigh them.

[0057] The results of the ointment yield test are shown in Table 3.

[0058] 5. Process Validation Test: Based on the prescription ratio, three portions of medicinal materials were weighed in parallel. The process was optimized using orthogonal experiments. The total saponin content, total flavonoid content, and extract yield were determined according to the above method to test the rationality and feasibility of the extraction process.

[0059] Based on the determination of total saponin and total flavonoid content, as well as the yield of extract, the results of the orthogonal experiment are shown in Table 3, and the results of the variance analysis of the extraction process are shown in Table 4.

[0060] Table 3 Results of Orthogonal Experiments

[0061] Table 4. Analysis of Variance of Extraction Process

[0062] According to the orthogonal experimental results, the influence of each factor on the comprehensive score is as follows: number of extractions (C) > extraction time (B) > ethanol concentration (A) > solvent volume (D). Further analysis using the ANOVA table shows that ethanol concentration (A), extraction time (B), and number of extractions (C) all have significant effects on the experimental results, with statistically significant differences (P < 0.05), while solvent volume (D) has no significant effect on the experimental results, with no statistically significant difference (P > 0.05). The comprehensive value indicates that the optimal extraction process is A2B3C3D2, that is, according to the prescription ratio, weigh and mix kudzu root and Panax notoginseng (coarsely crushed), add 8 times the amount of 70% ethanol, soak for 30 min before the first extraction, heat and reflux for 90 min each time, extract for a total of 3 times, filter, combine the filtrates, concentrate under reduced pressure at 55℃ to recover the solvent to obtain a thick paste, and dry in an oven at 75℃ to obtain GS extract.

[0063] The results of the process validation experiment are shown in Table 5. The calculated RSD values ​​for total saponin content, total flavonoid content, and extract yield were 1.87%, 2.67%, and 2.64%, respectively, all less than 3%. This indicates that the GS extraction process optimized by the orthogonal experiment has good stability and is reasonable and feasible.

[0064] Table 5 Process Validation Test Table

[0065] II. Study on the molding process of Pueraria lobata and Panax notoginseng tablets (GS) 1. Experimental methods 1.1 Preparation steps of GS extract S1. Take Pueraria lobata, remove impurities and non-medicinal parts, and crush into coarse powder; S2. Take Panax notoginseng main root or fibrous root, wash, dry and crush into coarse powder; S3. Mix Panax notoginseng and Pueraria lobata coarse powder and add to ethanol solution, heat and reflux; S4. Reflux extraction 3 times, filter the residue after each extraction, and add ethanol solution again for reflux extraction; S5. Combine the three extracts, filter and concentrate to obtain thick paste, and dry to obtain Pueraria lobata and Panax notoginseng extract.

[0066] Extraction was performed based on the results of the previous study on the optimal extraction process. According to the prescription ratio, kudzu root and coarsely crushed Panax notoginseng were weighed and mixed in a 2:1 mass ratio. Eight times the amount of 70% ethanol was added. For the first extraction, the mixture was soaked for 30 minutes, followed by reflux extraction for 90 minutes each time, for a total of three extractions. The extracts were filtered, and the filtrates were combined. The solvent was recovered by concentration under reduced pressure at 55℃ to obtain a thick paste, which was then dried in an oven at 75℃ to obtain the GS extract.

[0067] 1.2 GS Preparation Process Flow The GS preparation process flow is as follows: mixing GS extract with excipients, preparing soft material, granulation, drying, sizing, total mixing, and tableting.

[0068] 1.3 Investigation of Physical Properties of Raw Materials and Excipients 1.3.1 Moisture Content Detection Accurately weigh 2 g of each of three GS extracts and place them in evaporating dishes dried to constant weight. Accurately weigh the total weight M1 of the evaporating dishes and GS extracts. Heat in an oven at 105℃ for 3 h, then remove and quickly place in a desiccator to cool for 30 min. Accurately weigh the total weight M2 of the evaporating dishes and GS extracts, and calculate the moisture content of the GS extract.

[0069] 1.3.2 Flowability Test: A smooth glass funnel was fixed on an iron stand. A glass petri dish with a base radius of 3.5 cm was placed directly below the funnel. Three portions of 5 g each of raw materials and excipients were weighed in parallel and placed on strips of weighing paper. The materials were then slowly and continuously poured into the glass funnel. When no raw materials or excipients flowed out from the bottom of the funnel, the height of the accumulation was measured and the angle of repose was calculated. The smaller the angle of repose, the greater the flowability of the raw materials and excipients.

[0070] 1.3.3 Hygroscopicity test: Accurately weigh 2 g of raw materials and three portions of dried raw and auxiliary materials to constant weight, spread them evenly in a small drying beaker, accurately weigh the weight of the empty drying beaker M3 and the total weight of the drying beaker and the dried raw and auxiliary materials M4, place them in a sealed desiccator with 75% relative humidity (with built-in supersaturated NaCl solution) for 72 h, accurately weigh the total weight of the beaker and raw and auxiliary materials M5, and calculate the hygroscopicity of the raw and auxiliary materials.

[0071] 1.3.4 Compressibility Test: Place an appropriate amount of raw materials and excipients on weighing paper and allow them to flow evenly through a funnel into a 20 mL glass graduated cylinder until it reaches the 20 mL mark. Simultaneously, accurately weigh the total weight of the raw materials and excipients, and then divide by 20 to obtain the bulk density (g / mL). Impact the graduated cylinder until the height of the raw materials and excipients no longer changes. Divide the weighed total weight of the raw materials and excipients by the current volume of the powder to obtain the tapped density (g / mL).

[0072] 1.4 Tablet Quality Assessment Methods 1.4.1 Tablet Weight Variation Detection According to the 2020 edition of the Chinese Pharmacopoeia, Volume IV, 20 tablets were randomly selected for tablet weight variation detection. The weight variation limit was set at ±7.5% for average tablet weight below 0.30 g; and ±5% for average tablet weight of 0.30 g or above. Furthermore, no more than two tablets should exceed the weight limit, and no single tablet should exceed the limit by more than 100%.

[0073] 1.4.2 Friability Test: Friability test shall be conducted in accordance with Part IV of the 2020 edition of the Chinese Pharmacopoeia, and the weight loss shall not exceed 1%.

[0074] 1.4.3 Disintegration time limit test: According to the 2020 edition of the Chinese Pharmacopoeia, Part IV, the disintegration time limit test shall be conducted, and the extract tablets shall be completely disintegrated within 1 hour.

[0075] 2.5 Study on the molding process of GS 2.5.1 Investigation of fillers Based on the hygroscopic nature of GS extract, excipients that are not hygroscopic, have good compressibility and good flowability were selected as fillers, such as lactose, dextrin, starch and microcrystalline cellulose. The best filler was selected by evaluating the granulation condition (soft material properties, degree of agglomeration and fine powder content) and the granule yield.

[0076] 2.5.1.1 Screening of filler types: Lactose, dextrin, starch, and microcrystalline cellulose were selected as fillers. 70% ethanol was selected as a wetting agent. After the filler and GS extract were mixed evenly at a ratio of 2:1, an appropriate amount of wetting agent was sprayed on, and after forming a soft mass, it was granulated and placed in an oven at 65℃ for 5 min to dry. The granulation condition and particle yield were used as evaluation indicators to screen the types of fillers. The formulation is shown in Table 6.

[0077] Table 6 Prescription Table

[0078] 2.5.1.2 Screening of Filler Ratio Based on the physical properties of raw materials and excipients, including flowability, hygroscopicity, and compressibility, and combined with granulation conditions and particle yield, a comprehensive evaluation was conducted. Excipients with low hygroscopicity, good flowability, good compressibility, good granulation conditions, and high particle yield were selected as fillers. 70% ethanol was selected as a wetting agent. The ratio of raw materials to excipients was set to 1:1, 1:2, and 1:3, and the granulation conditions and particle yield were examined to screen out the optimal filler ratio.

[0079] 2.5.2 Investigation of Wetting Agent Concentration Ethanol was selected as the wetting agent, and concentrations of 60%, 70%, and 80% were set. After the GS extract and filler were mixed evenly at a ratio of 1:2, appropriate amounts of ethanol at different concentrations were sprayed for granulation. Based on the granulation results (soft material properties, degree of agglomeration, and amount of fine powder) and particle yield, the optimal wetting agent concentration was selected.

[0080] 2.5.3 The final molding process is determined by using granulation conditions and granule yield as evaluation indicators to initially screen fillers and wetting agents and then compress tablets. The tablet appearance, disintegration time, friability, and tablet weight difference are used as tablet quality evaluation indicators for final process screening.

[0081] 3. Experimental Results 3.1 Results of Physical Property Investigation of Raw Materials and Excipients 3.1.1 Results of Moisture Content Test of Raw Material The moisture content test results of the raw material are shown in Table 7. The moisture content of the GS extract was between 0.84% ​​and 0.86%, indicating stable properties, suitable for subsequent formulation testing. Table 7 Results of Moisture Content Test of GS Extract (n=3)

[0082] 3.1.2 Results of Raw Material and Excipient Flowability Test The results of the raw material and excipient flowability test are shown in Table 8. Except for the GS extract, the flowability from highest to lowest is lactose > starch > microcrystalline cellulose > dextrin.

[0083] Table 8 Results of flowability tests for raw materials and excipients (n=3)

[0084] 3.1.3 Results of Hygroscopicity Tests for Raw Materials and Excipients The results of hygroscopicity tests for raw materials and excipients are shown in Table 9. Except for the GS extract, the hygroscopicity, from lowest to highest, is: microcrystalline cellulose < starch < dextrin < lactose.

[0085] Table 9 Results of hygroscopicity test of raw materials and excipients (n=3)

[0086] 3.1.4 Compressibility Test Results of Raw Materials and Excipients The compressibility test results of raw materials and excipients are shown in Table 10. Except for the GS extract, the compressibility from highest to lowest is dextrin > lactose, starch > microcrystalline cellulose. Table 10 Compressibility Test Results of Raw Materials and Excipients

[0087] 3.2 Results of the evaluation of fillers Based on the hygroscopic nature of GS extract, excipients that are not hygroscopic, have good compressibility and good flowability were selected as fillers, such as lactose, dextrin, starch and microcrystalline cellulose. The best filler was selected by using granulation conditions and granule yield as evaluation indicators.

[0088] 3.2.1 Results of Filler Selection The results of filler selection are shown in Table 11. Considering the physical properties of raw materials and excipients, granulation conditions, and granule yield, starch was ultimately selected as the filler.

[0089] Table 11 Results of Filler Type Screening Test

[0090] 3.2.2 Filler Ratio Screening Results The filler ratio screening results are shown in Table 12. Based on the granulation process and particle yield, a raw material to excipient ratio of 1:2 was selected for tableting.

[0091] Table 12 Results of Filler Ratio Screening Test

[0092] 3.3 Results of wetting agent concentration investigation: The results of the wetting agent concentration investigation are shown in Table 13. Based on the granulation conditions and particle yield, a 70% ethanol concentration was selected for formulation.

[0093] Table 13 Results of wetting agent concentration screening test

[0094] 3.4 Final Molding Process Determination Granulation and granule yield were used as evaluation indicators. Based on the physical properties of raw materials and excipients, as well as the consideration of fillers and wetting agents, preliminary screening was conducted, selecting starch as the filler and 70% ethanol as the wetting agent for tableting. To determine the final molding process, tablet quality also needed to be assessed. Using starch as the filler and 70% ethanol as the wetting agent, the ratio of GS extract to starch was set at 1:1, 1:2, and 1:3, with an appropriate amount of magnesium stearate added as a lubricant. Tablet appearance, disintegration time, friability, and tablet weight variation were used as tablet quality evaluation indicators for final process screening. The results are shown in Table 14. Tablets made with a GS extract to filler ratio of 1:2 had a smooth surface, uniform color, and the friability, disintegration time, and tablet weight variation all met the requirements.

[0095] Table 14 Final Molding Process Determination Results

[0096] III. Comparison of the efficacy of Pueraria lobata and Panax notoginseng tablets (GS) with Panax notoginseng and Pueraria lobata alone on diabetic atherosclerotic zebrafish 1 Experimental methods 1.1 Preparation of GS solution Weigh an appropriate amount of GS, crush it into powder, add embryo water, sonicate to dissolve and filter, and prepare a GS stock solution with a concentration of 200 μg / mL for later use.

[0097] 1.2 Preparation of Single-Herb Panax Notoginseng Solution The extraction method for single-herb Panax notoginseng is the same as the "GS Extraction Method". Weigh 50g of coarsely crushed Panax notoginseng, add 8 times the amount of 70% ethanol, soak for 30min before the first extraction, and reflux for 90min each time, for a total of 3 extractions. Filter, combine the filtrates, concentrate under reduced pressure at 55℃ to recover the solvent and obtain a thick paste, dry in an oven at 75℃ to obtain the Panax notoginseng extract. Weigh an appropriate amount of the Panax notoginseng extract, add embryonic water, sonicate to dissolve and filter, and prepare a 200 μg / mL Panax notoginseng extract stock solution for later use.

[0098] 1.3 Preparation of Single-Herb Kudzu Root Solution The extraction method for single-herb kudzu root is the same as that in "GS Extraction Method". Weigh 50g of kudzu root and add 8 times the amount of 70% ethanol. Soak for 30min before the first extraction. Reflux for 90min each time, for a total of 3 extractions. Filter, combine the filtrates, concentrate under reduced pressure at 55℃ to recover the solvent, and dry in an oven at 75℃ to obtain kudzu root extract. Weigh an appropriate amount of kudzu root extract, add embryonic water, sonicate to dissolve, and filter to prepare a 200 μg / mL kudzu root extract stock solution for later use.

[0099] 1.4 Grouping and Drug Administration: 3-day-fed zebrafish juveniles with normal development were placed in a 6-well plate with 30 fish per well and 3 duplicate wells per group. Normal group: cultured in normal embryonic water containing PTU; Model group: cultured in embryonic water containing 10 mg / mL glucose + 0.0015% PTU; Panax notoginseng group (SQ): cultured in embryonic water containing 10 mg / mL glucose + 0.0015% PTU + 100 μg / mL Panax notoginseng extract; Pueraria lobata group (GG): cultured in embryonic water containing 10 mg / mL glucose + 0.0015% PTU + 100 μg / mL Pueraria lobata extract; GS extract: cultured in embryonic water containing 10 mg / mL glucose + 0.0015% PTU + 100 μg / mL GS. Except for the normal group, which was given 1 mg of basal diet twice a day (morning and afternoon), all other groups were given a high-fat diet. The water was changed at the same time as feeding. The animals were incubated at 26°C until 6 days post-feeding (dpf) and then the corresponding tests were performed.

[0100] 1.4.1 Effects of GS and Single-herb Panax notoginseng and Pueraria lobata on glucose content in zebrafish model: AB wild-type zebrafish eggs were used in the experiment. Grouping, modeling, and drug administration were the same as in "1.4 Grouping, Modeling, and Drug Administration". After drug intervention, 30 juvenile fish were randomly selected from each group, cleaned with PBS, and centrifuged at low speed in centrifuge tubes with filters to remove surface moisture. The fish were then transferred to 1.5 mL centrifuge tubes, accurately weighed, and 10 μL of PBS was added to each group for homogenization on ice. The homogenized tissue was then placed in a refrigerated centrifuge at 4℃ and centrifuged at 8000 r·min. -1 Centrifuge for 5 minutes, collect the supernatant, and detect the GLU content of each group of zebrafish according to the kit instructions.

[0101] 1.4.2 Effects of GS and Single-herb Panax notoginseng and Pueraria lobata on Arterial Plaques in Zebrafish Model The experiment used eggs from wild-type AB zebrafish. Grouping, modeling, and drug administration were the same as in "1.2 Grouping, Modeling, and Drug Administration". After drug intervention, 10 juvenile fish were randomly selected from each group. After washing with embryonic water, the fish were washed once with PBS, then fixed overnight with paraformaldehyde. The next day, the juvenile fish were rinsed twice with PBS, and an appropriate amount of staining washing solution was added to cover the juvenile fish for 20 s. The cell washing solution was removed, and an appropriate amount of modified Oil Red O staining solution was added for staining for 30 min. The Oil Red O staining solution was removed, and the fish were washed once with PBS. The stained juvenile fish were placed in methylcellulose and positioned in a lateral recumbent position. The arterial vessels were photographed using a stereomicroscope to observe the arterial plaques.

[0102] 2. Experimental Results 2.1 Effects of GS and Single-herb Panax notoginseng and Pueraria lobata on Glucose Content in Zebrafish Model The results of the effects of GS and single-herb Panax notoginseng and Pueraria lobata on glucose content in zebrafish model are shown in Table 15. Compared with the blank group, the glucose content of the model group was significantly increased (P < 0.001); compared with the model group, SQ, GG and GS administration significantly reduced the glucose content of zebrafish (P < 0.05, 0.001), but the glucose content of zebrafish in the GS group was lower than that in the SQ and GG groups, and GS had a better hypoglycemic effect than SQ and GG.

[0103] Table 15 Glucose content of zebrafish in each group

[0104]

[0105] Note: Compared with the Model group, *P<0.05, ***P<0.001.

[0106] 2.2 Effects of GS and Panax notoginseng and Pueraria lobata on arterial plaques in zebrafish model. The effects of GS and Panax notoginseng and Pueraria lobata on lipid plaques in the arteries of zebrafish model are shown in Figure 4. Almost no lipid plaques were observed in the arteries of zebrafish in the control group. A relatively large number of lipid plaques were observed in the arteries of zebrafish in the model group, which were stained red by Oil Red O. The number of lipid plaques in the arteries of zebrafish in the SQ, GG, and GS groups was significantly reduced compared to the model group, with the GS group having the fewest lipid plaques.

[0107] IV. Study on the efficacy of Pueraria lobata and Panax notoginseng tablets (GS) in a zebrafish diabetic atherosclerosis model 1. Experimental methods 1.1 Preparation of GS solution Weigh an appropriate amount of GS, crush it into powder, add embryonic water, sonicate to dissolve and filter, and prepare a GS stock solution with a concentration of 200 μg / mL for later use.

[0108] 1.2 Grouping and Drug Administration: Zebrafish juveniles with normal development at 3dpf were placed in a 6-well plate with 30 fish per well. They were divided into a blank group (Normal), a model group (Model), a positive control group (Metformin), a high-dose group of Pueraria lobata tablets (GS-H), and a low-dose group of Pueraria lobata tablets (GS-L). Each group had 3 replicates. Normal group: cultured in normal embryonic water containing PTU; Model group: cultured in embryonic water containing 10 mg / mL glucose + 0.0015% PTU; Metformin group: cultured in embryonic water containing 10 mg / mL glucose + 0.0015% PTU + 200 μg / mL metformin; High-dose group (GS-H) and low-dose group (GS-L): cultured in embryonic water containing 10 mg / mL glucose + 0.0015% PTU + 100 or 50 μg / mL GS, respectively. Except for the normal group, which was given 1 mg of basal diet twice a day (morning and afternoon), the other groups were given a high-fat diet. The water was changed at the same time as feeding. The animals were kept in an incubator at 26°C until 6 days post-feeding (dpf) and then the corresponding tests were performed.

[0109] 1.3 Effects of GS on Glucose, Cholesterol, and Triglyceride Content in a Zebrafish Model 1.3.1 Effect of GS on Glucose Content in a Zebrafish Model Wild-type AB zebrafish eggs were used in the experiment. Grouping, modeling, and drug administration were the same as in "1.2 Grouping, Modeling, and Drug Administration". After drug intervention, 30 juvenile fish were randomly selected from each group, cleaned with PBS, and centrifuged at low speed in centrifuge tubes with filters to remove surface moisture. The fish were then transferred to 1.5 mL centrifuge tubes, accurately weighed, and 10 μL of PBS was added to each group for homogenization on ice. The homogenized tissue was then placed in a refrigerated centrifuge at 4℃ and centrifuged at 8000 r·min. -1 Centrifuge for 5 minutes, collect the supernatant, and detect the GLU content of each group of zebrafish according to the kit instructions.

[0110] 1.3.2 Effect of GS on Cholesterol Content in Zebrafish Model The experiment used eggs from wild-type AB zebrafish. Grouping, modeling, and drug administration were the same as in "1.2 Grouping, Modeling, and Drug Administration". After drug intervention, 90 juvenile fish were randomly selected from each group, cleaned with PBS, and centrifuged at low speed in centrifuge tubes with filters to remove surface moisture. The fish were then transferred to clean 1.5 mL centrifuge tubes, accurately weighed, and 40 μL of PBS was added to each group for homogenization on ice. The homogenized tissue was then centrifuged at 8000 r·min⁻¹ for 5 min at 4℃. The supernatant was collected, and the TC content of each group of zebrafish was measured according to the kit instructions.

[0111] 1.3.3 Effect of GS on Triglyceride Content in Zebrafish Model: Experiments were conducted using eggs from wild-type AB zebrafish. Grouping, modeling, and drug administration were the same as described in "1.2 Grouping, Modeling, and Drug Administration". After drug intervention, 30 juvenile fish were randomly selected from each group. The methods for collecting fish, homogenizing, and obtaining supernatant were the same as described in "1.3.1 Effect of GS on Glucose Content". The supernatant was collected, and the TG content of each group of zebrafish was measured according to the kit instructions.

[0112] 1.4 Effects of GS on Arterial Plaques in a Zebrafish Model The experiment used eggs from wild-type AB zebrafish. Grouping, modeling, and drug administration were the same as described in "1.2 Grouping, Modeling, and Drug Administration". After drug intervention, 10 juvenile fish were randomly selected from each group. After washing with embryonic water, the fish were washed once with PBS, then fixed overnight with paraformaldehyde. The next day, the juvenile fish were rinsed twice with PBS, and an appropriate amount of staining washing solution was added to cover the juvenile fish for 20 seconds. The cell washing solution was removed, and an appropriate amount of modified Oil Red O staining solution was added for staining for 30 minutes. The Oil Red O staining solution was removed, and the fish were washed once more with PBS. The stained juvenile fish were placed in methylcellulose and positioned in a lateral recumbent position. Arterial blood vessels were photographed using a stereomicroscope to observe the arterial plaques.

[0113] 1.5 Effect of GS on Arterial Vessel Width in a Zebrafish Model The experiment used eggs from s843Tg / +AB type zebrafish (transgenic zebrafish with green fluorescent markers for vascular endothelial cells). Grouping, modeling, and drug administration were the same as in "1.2 Grouping, Modeling, and Drug Administration". After drug intervention, five juvenile fish were randomly selected from each group. After rinsing with embryonic water, they were placed in agarose gel and quickly positioned in a lateral recumbent position. After the agarose gel had completely solidified, the arterial vessels above the cloaca were photographed using a phase-contrast inverted microscope. The width of the arterial vessels was calculated using ImageJ software at three selected locations, and the average value was calculated.

[0114] 1.6 Effects of GS on Arterial Endothelial Cells in a Zebrafish Model The experiment used eggs from s843Tg / +AB type zebrafish (transgenic zebrafish with green fluorescent markers for endothelial cells). Grouping, modeling, and drug administration were the same as described in "2.2 Grouping, Modeling, and Drug Administration". After drug intervention, 10 juvenile fish were randomly selected from each group. After rinsing with embryonic water, the fish were anesthetized with 0.05% fish tranquilizer for 5 seconds, then placed in methylcellulose gel and quickly positioned in a lateral recumbent position. The arterial vessels of the juvenile fish were photographed using a stereofluorescence microscope, and the fluorescence intensity of the arterial vessels was calculated using ImageJ software.

[0115] 1.7 Effect of GS on Inflammatory Response in Zebrafish Model The experiment used eggs from nz50Tg / +AB type zebrafish (transgenic zebrafish with red fluorescence marking neutrophils) for the experiment. Grouping, modeling, and drug administration were the same as in "2.2 Grouping, Modeling, and Drug Administration". After drug intervention, 10 juvenile fish were randomly selected from each group. After rinsing with embryonic water, the fish were first anesthetized with 0.05% fish tranquilizer for 5 seconds, then placed in methylcellulose gel, and quickly positioned in a lateral recumbent position. Whole-body fluorescence microscopy was used to photograph the juvenile fish, and the fluorescence intensity of whole-body neutrophils was calculated using ImageJ software.

[0116] 1.8 Effects of GS on Pancreatic Islet β Cells in a Zebrafish Model The experiment used eggs from jh2Tg / +AB type zebrafish (transgenic zebrafish with red fluorescence marking pancreatic β cells). Grouping, modeling, and drug administration were the same as in "2.2 Grouping, Modeling, and Drug Administration". After drug intervention, 10 juvenile fish were randomly selected from each group. After rinsing with embryonic water, they were first anesthetized with 0.05% fish tranquilizer for 5 seconds, then placed in methylcellulose gel, and quickly positioned in a lateral recumbent position. The pancreatic islets of the juvenile fish were photographed using a stereofluorescence microscope, and the fluorescence intensity of pancreatic β cells was calculated using ImageJ software.

[0117] 2. Experimental Results 2.1 Effects of GS on Glucose, Cholesterol, and Triglyceride Content in Zebrafish Model The results of the effects of GS on glucose, cholesterol, and triglyceride content in zebrafish model are shown in Table 16 and Figure 3. Compared with the control group, the glucose, cholesterol, and triglyceride content in the model group was significantly increased (P < 0.001); compared with the model group, GS administration significantly reduced the glucose, cholesterol, and triglyceride content in zebrafish (P < 0.05, 0.01, 0.001, respectively).

[0118] Table 16. Glucose, cholesterol, and triglyceride content in zebrafish after GS administration.

[0119]

[0120] Note: Compared with the Model group, *P<0.05, **P<0.01, ***P<0.001.

[0121] 2.2 Effect of GS on lipid plaques in zebrafish arteries. The effect of GS on lipid plaques in zebrafish arteries is shown in Figure 5. Almost no lipid plaques were observed in the arteries of the blank group zebrafish, while a large number of lipid plaques were found in the arteries of the model group zebrafish, which stained red with Oil Red O. The number of lipid plaques in the arteries of zebrafish in the GS-H and GS-L groups was significantly reduced compared to the model group, indicating that GS can reduce the formation of diabetic atherosclerotic plaques.

[0122] 2.3 Effect of GS on the width of zebrafish arteries The results of the effect of GS on the width of zebrafish arteries are shown in Table 17 and Figure 6. Compared with the blank group, the width of the arteries of zebrafish in the model group was significantly increased (P<0.001). Compared with the model group, GS administration significantly reduced the width of zebrafish arteries (P<0.001).

[0123] Table 17. Arterial vascular width in zebrafish after GS administration

[0124]

[0125] Note: Compared with the Model group, ***P < 0.001.

[0126] 2.4 Effects of GS on arterial endothelial cells in zebrafish model. The results of the effects of GS on arterial endothelial cells in zebrafish model are shown in Table 18 and Figure 7. Compared with the blank group, the fluorescence intensity of zebrafish arteries in the model group was significantly enhanced (P < 0.001). Compared with the model group, GS administration significantly reduced the fluorescence intensity of zebrafish arteries (P < 0.05).

[0127] Table 18 Fluorescence intensity of zebrafish arterial endothelial cells after GS administration

[0128]

[0129] Note: Compared with the Model group, *P<0.05, ***P<0.001.

[0130] 2.5 Effects of GS on the inflammatory response of zebrafish model The results of the effects of GS on the inflammatory response of zebrafish model are shown in Table 19 and Figure 8. Compared with the blank group, the fluorescence intensity of neutrophils in zebrafish in the model group was significantly enhanced (P < 0.001); compared with the model group, GS administration significantly reduced the fluorescence intensity of neutrophils in zebrafish (P < 0.05).

[0131] Table 19 Fluorescence intensity of zebrafish neutrophils after GS administration

[0132]

[0133] Note: Compared with the Model group, *P<0.05, **P<0.01, ***P<0.001.

[0134] 2.6 Effects of GS on pancreatic β-cells in a zebrafish model. The results of the effects of GS on pancreatic β-cells in a zebrafish model are shown in Table 20 and Figure 9. Compared with the control group, the fluorescence intensity of pancreatic β-cells in the model group was significantly reduced (P < 0.001). Compared with the model group, GS-H administration significantly enhanced the fluorescence intensity of pancreatic β-cells in zebrafish (P < 0.05), while GS-L administration had no significant effect on the fluorescence intensity of pancreatic β-cells in zebrafish (P > 0.05).

[0135] Table 20. Fluorescence intensity of zebrafish pancreatic β cells after GS administration

[0136]

[0137] Note: Compared with the Model group, *P<0.05, ***P<0.001.

Claims

1. A method for preparing a Pueraria lobata and Panax notoginseng extract, characterized in that, Includes the following steps: Step S1: Take kudzu root, remove impurities and non-medicinal parts, and grind into coarse powder; Step S2: Take the main root or fibrous root of Panax notoginseng, wash and dry it, and grind into coarse powder; Step S3: Mix Panax notoginseng and kudzu root coarse powder and add to ethanol solution, then heat under reflux; Step S4: Reflux extract 3 times, filter the residue after each extraction, and then add ethanol solution for reflux extraction again; Step S5: Combine the three extracts, filter and concentrate to obtain a thick paste, and dry to obtain kudzu root and Panax notoginseng extract.

2. The method for preparing a Pueraria lobata extract according to claim 1, characterized in that: In step S3, the mass ratio of kudzu root to Panax notoginseng is 2:1, and the mixture is passed through a 20-50 mesh sieve.

3. The method for preparing a Pueraria lobata extract according to claim 2, characterized in that: The concentration of the ethanol solution is 50%-70%, and the mass-volume ratio of Panax notoginseng powder and Pueraria lobata powder to the ethanol solution is 1:6-8 kg / L.

4. The method for preparing a Pueraria lobata extract according to claim 1, characterized in that: Soak the sample before the first extraction, and reflux for 60-90 minutes each time.

5. The method for preparing a Pueraria lobata extract according to claim 1, characterized in that: In step S5, the concentration temperature under reduced pressure is 50-60℃, and the thick paste is dried in an oven at 70-80℃.

6. A type of kudzu root and Panax notoginseng tablet, characterized in that: The kudzu root and Panax notoginseng extract GS prepared by any one of claims 1-5 is mixed with excipients, made into a soft mass, granulated, dried, sized, mixed, and compressed into tablets to obtain kudzu root and Panax notoginseng tablets.

7. A kudzu root and Panax notoginseng tablet according to claim 6, characterized in that: The filler in the excipients is selected from one or more of lactose, dextrin, starch, and microcrystalline cellulose. First, a 60-80% ethanol solution is selected as a wetting agent. After the excipients and GS extract are mixed evenly, an appropriate amount of wetting agent is sprayed on, and after forming a soft mass, it is granulated and placed in an oven to dry and granulate.

8. A kudzu root and Panax notoginseng tablet according to claim 7, characterized in that: The filler is starch, and the excipients also include magnesium stearate. The ratio of GS extract to filler is 1:1-3, and the wetting agent is 70% ethanol.

9. The use of the Pueraria lobata extract prepared by the method of any one of claims 1-5 in the preparation of a medicament or health product for the prevention and / or treatment of diabetic atherosclerosis.

10. The application of Pueraria lobata extract for preventing diabetic atherosclerosis according to claim 9, characterized in that: The Pueraria lobata extract exerts its preventive and / or therapeutic effects on diabetic atherosclerosis through one or more mechanisms, including protecting vascular endothelium and pancreatic β-cells, regulating glucose and lipid metabolism, and inhibiting inflammatory responses.

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