Pharmaceutical composition helpful for reducing blood glucose as well as preparation and application thereof

Abstract

The invention provides a pharmaceutical composition helpful for reducing blood glucose as well as a preparation and application thereof, and relates to the field of medicines. The pharmaceutical composition helpful for reducing blood glucose comprises the following raw materials in parts by weight: 15-20 parts of pomegranate, 8-13 parts of turmeric, 1-2 parts of bear gall, 1-2 parts of schisandra chinensis, 10-15 parts of dendrobe, 5-10 parts of folium eriobotryae, 8-12 parts of radix puerariae, 5-10 parts of dandelion, 8-15 parts of herba epimedii, 8-12 parts of polygonum cuspidatum, 5-8 parts of gynostemma pentaphyllum, 4-8 parts of inula flower and 3-5 parts of cortex lycii radicis. The pharmaceutical composition disclosed by the invention effectively inhibits sugar absorption of intestinal tracts, enhances insulin sensitivity, improves insulin resistance, promotes activity of glucose transporter protein, regulates glycolipid metabolism balance, inhibits liver glycogen decomposition to reduce liver glucose output and reduces interference of inflammatory factors on insulin signal channels through a multi-channel synergistic effect; therefore, the whole metabolic regulation is optimized, the blood sugar level is remarkably reduced, the number of pancreatic beta cells is increased, and the compound can be applied to preparation of drugs for treating diabetes.

Description

Technical Field

[0001] The present invention relates to the field of medicine, and in particular to a medicine composition that helps lower blood sugar, and its preparation and application. Background Art

[0002] Chronic hyperglycemia can cause damage to the eyes, nerves, kidneys, and cardiovascular and cerebrovascular systems, increasing the risk of complications including retinopathy, diabetic nephropathy, and peripheral neuropathy. When fasting blood glucose levels exceed 7.0 mmol / L, glucolipid toxicity exacerbates insulin resistance, creating a vicious cycle of beta-cell dysfunction and exacerbated hyperglycemia. This can also trigger cardiovascular risk factors such as dyslipidemia and elevated blood pressure. Clinical studies have confirmed that lowering HbA1c levels can help reduce the risk of microvascular complications, myocardial infarction, and diabetes-related mortality.

[0003] Some glucose-lowering drugs, such as insulin and sulfonylureas, can easily cause hypoglycemia, leading to large blood sugar fluctuations. Others carry the risk of gastrointestinal side effects, hepatotoxicity, and lactic acidosis. In summary, traditional glucose-lowering drugs have shortcomings in terms of safety, side effects, and therapeutic efficacy. Summary of the Invention

[0004] The present invention provides a drug composition that helps lower blood sugar, a preparation thereof, and an application thereof. The drug composition lowers blood sugar levels, stabilizes the blood sugar levels after the reduction, and has good safety.

[0005] The technical solution of the present invention is achieved as follows: a pharmaceutical composition that helps lower blood sugar, comprising the following raw materials in parts by weight: 15-20 parts of pomegranate, 8-13 parts of turmeric, 1-2 parts of bear bile, 1-2 parts of schisandra chinensis, 10-15 parts of dendrobium, 5-10 parts of loquat leaves, 8-12 parts of kudzu root, 5-10 parts of dandelion, 8-15 parts of epimedium, 8-12 parts of knotweed, 5-8 parts of gynostemma pentaphyllum, 4-8 parts of inula flower, and 3-5 parts of lycium bark.

[0006] Preferably, the pharmaceutical composition comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of kudzu root, 8 parts of dandelion, 12 parts of epimedium, 10 parts of knotweed, 7 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 4 parts of Lycium bark.

[0007] Furthermore, the preparation method of the pharmaceutical composition comprises the following steps: (1) Add 7-9 times the amount of purified water to pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark, and boil for 2-3 times, each time for 1-2 hours. Filter, combine the filtrates, and concentrate to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria lobata with 70%-80% v / v ethanol under reflux for 2-3 times, each time for 1-1.5 hours. Combine the extracts and recover the ethanol to obtain extract B. (3) Decoction the loquat leaves and inula flower separately for 40-50 minutes, filter and obtain the medicinal solution; (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain a mixed raw material drug, add a binder, make pills, sterilize, and package.

[0008] Furthermore, in step (1), the decoction is performed three times, the first time for 2 hours, the second time for 1.5 hours, and the third time for 1 hour.

[0009] Furthermore, in step (1), the concentration is specifically: concentrating at 55-65° C. to a relative density of 1.25-1.30.

[0010] Furthermore, in step (2), reflux extraction was performed twice, the first time for 1.5 h and the second time for 1.0 h.

[0011] A drug preparation that helps lower blood sugar is prepared from the drug composition of the present invention.

[0012] The pharmaceutical composition of the present invention is used in preparing hypoglycemic drugs.

[0013] Furthermore, the pharmaceutical composition of the present invention is used in the preparation of drugs for treating diabetes.

[0014] Compared with the prior art, the present invention has the following beneficial effects: (1) The pharmaceutical composition of the present invention effectively inhibits intestinal sugar absorption through the synergistic action of multiple pathways, while enhancing insulin sensitivity and improving insulin resistance. It also promotes the activity of glucose transporters, regulates the balance of glucose and lipid metabolism, inhibits hepatic glycogenolysis to reduce hepatic glucose output, and reduces the interference of inflammatory factors on the insulin signaling pathway, thereby optimizing overall metabolic regulation.

[0015] (2) The pharmaceutical composition of the present invention can significantly lower blood sugar levels, increase the number of pancreatic β cells, improve pancreatic cell function, reduce daily blood sugar fluctuations, and help restore blood sugar levels close to normal and maintain stability. It can be used to prepare drugs for the treatment of type 2 diabetes, especially for patients with pancreatic islet dysfunction and metabolic disorders.

[0016] (3) In the present invention's pharmaceutical composition, pomegranate nourishes yin and promotes fluid production, turmeric invigorates blood and promotes qi circulation, and they are both the main medicines; kudzu root promotes fluid production and quenches thirst, promotes spleen and stomach to clear yang, gynostemma pentaphyllum invigorates qi and strengthens spleen, and bear bile invigorates liver and clears fire, and they are both the assistant medicines; Polygonum cuspidatum removes blood stasis and unclogs meridians, and epimedium warms kidney and promotes yang, and epimedium and Polygonum cuspidatum work together to strengthen kidney and consolidate essence, promote blood circulation and unclog meridians; Schisandra chinensis and Dendrobium can nourish kidney yin and consolidate body fluids, and dandelion and Rehmannia root bark clear lung and stomach fire, and Schisandra chinensis, Dendrobium can clear lung and stomach fire, and Rehmannia root, Dendrobium can clear lung and stomach fire, and Schisandra chinensis, Dendrobium can clear lung and stomach fire, and they are both the adjuvants. Inula flower descends qi and resolves phlegm, directs the medicinal power to the middle jiao spleen and stomach, and coordinates the rise and fall of the various medicines.

[0017] (4) The pharmaceutical composition of the present invention is scientifically formulated with thirteen Chinese medicinal materials, has no toxic side effects, and has good safety. DETAILED DESCRIPTION

[0018] Unless otherwise specified, the experimental methods used in the examples of the present invention are all conventional methods; The raw materials used in the embodiments of the present invention are all commercially available Chinese medicinal materials; The bear bile used in the embodiment of the present invention is commercially available artificial bear bile; The loquat leaves used in the embodiments of the present invention are raw premium loquat leaves, a traditional Chinese medicine.

[0019] Example 1 A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of kudzu root, 8 parts of dandelion, 12 parts of epimedium, 10 parts of knotweed, 7 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 4 parts of lycium bark.

[0020] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark were decocted with 8 times the amount of purified water for 3 times, the first time for 2.0 h, the second time for 1.5 h, and the third time for 1.0 h. Filter, combine the filtrates, and concentrate to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria root with 70% v / v ethanol under reflux twice, the first time for 1.5 h and the second time for 1.0 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 40 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0021] Example 2 A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 15 parts of pomegranate, 13 parts of turmeric, 1 part of bear bile, 1.8 parts of schisandra chinensis, 15 parts of dendrobium, 6.5 parts of loquat leaves, 12 parts of kudzu root, 10 parts of dandelion, 8 parts of epimedium, 8 parts of knotweed, 5 parts of gynostemma pentaphyllum, 8 parts of inula flower, and 3 parts of lycium bark.

[0022] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark were added to 8 times the amount of purified water and decocted three times, the first time for 2.0 h, the second time for 1.5 h, and the third time for 1.0 h. Filter, combine the filtrates, and concentrate to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria root with 70% v / v ethanol under reflux twice, the first time for 1.5 h and the second time for 1.0 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 40 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0023] Example 3 A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 20 parts of pomegranate, 8.5 parts of turmeric, 2 parts of bear bile, 1.3 parts of schisandra chinensis, 12 parts of dendrobium, 10 parts of loquat leaves, 8 parts of kudzu root, 5 parts of dandelion, 15 parts of epimedium, 12 parts of knotweed, 8 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 5 parts of lycium bark.

[0024] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark were added to 8 times the amount of purified water and decocted three times, the first time for 2.0 h, the second time for 1.5 h, and the third time for 1.0 h. Filter, combine the filtrates, and concentrate to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria root with 70% v / v ethanol under reflux twice, the first time for 1.5 h and the second time for 1.0 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 40 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0025] Example 4 A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of kudzu root, 8 parts of dandelion, 12 parts of epimedium, 10 parts of knotweed, 7 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 4 parts of lycium bark.

[0026] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark were added to 7 times the amount of purified water and decocted twice for 2.0 h each time. The filtrate was filtered, combined, and concentrated to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria root with 75% v / v ethanol under reflux twice, each time for 1.5 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 45 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0027] Example 5 A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of kudzu root, 8 parts of dandelion, 12 parts of epimedium, 10 parts of knotweed, 7 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 4 parts of lycium bark.

[0028] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark were added to 9 times the amount of purified water and decocted three times for 1.5 hours each time. The filtrates were combined and concentrated to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria lobata with 80% v / v ethanol under reflux twice, each time for 1.0 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 50 min. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0029] Comparative Example 1 This comparative example differs from Example 1 primarily in that a pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 10 parts pomegranate, 10 parts turmeric, 1.5 parts bear bile, 1.5 parts schisandra chinensis, 10 parts dendrobium, 10 parts loquat leaf, 10 parts kudzu root, 10 parts dandelion, 10 parts epimedium, 10 parts knotweed, 10 parts gynostemma pentaphyllum, 10 parts inula flower, and 10 parts lycium bark. The preparation method of the pharmaceutical composition is the same as that of Example 1.

[0030] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark were added to 8 times the amount of purified water and decocted three times, the first time for 2.0 h, the second time for 1.5 h, and the third time for 1.0 h. Filter, combine the filtrates, and concentrate to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria root with 70% v / v ethanol under reflux twice, the first time for 1.5 h and the second time for 1.0 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 40 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0031] Comparative Example 2 The main difference between this comparative example and Example 1 is that Gynostemma pentaphyllum is replaced by Atractylodes macrocephala.

[0032] A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of kudzu root, 8 parts of dandelion, 12 parts of epimedium, 10 parts of knotweed, 7 parts of atractylodes macrocephala, 6 parts of inula flower, and 4 parts of lycium bark.

[0033] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Atractylodes macrocephala, and Lycium bark were added to 8 times the amount of purified water and decocted three times, the first time for 2.0 h, the second time for 1.5 h, and the third time for 1.0 h. Filter, combine the filtrates, and concentrate to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria root with 70% v / v ethanol under reflux twice, the first time for 1.5 h and the second time for 1.0 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 40 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0034] Comparative Example 3 The main difference between this comparative example and Example 1 is that Pueraria root is replaced by Astragalus root.

[0035] A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of astragalus, 8 parts of dandelion, 12 parts of epimedium, 10 parts of knotweed, 7 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 4 parts of lycium bark.

[0036] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark were added to 8 times the amount of purified water and decocted three times, the first time for 2.0 h, the second time for 1.5 h, and the third time for 1.0 h. Filter, combine the filtrates, and concentrate to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Astragalus membranaceus with 70% v / v ethanol under reflux twice, the first time for 1.5 h and the second time for 1.0 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 40 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0037] Comparative Example 4 The main difference between this comparative example and Example 1 is that Epimedium is replaced by Rehmannia glutinosa.

[0038] A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of kudzu root, 8 parts of dandelion, 12 parts of rehmannia root, 10 parts of knotweed, 7 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 4 parts of lycium bark.

[0039] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, rehmannia root, gynostemma pentaphyllum, and lycium bark were added to 8 times the amount of purified water and decocted three times, the first time for 2.0 h, the second time for 1.5 h, and the third time for 1.0 h. Filter, combine the filtrates, and concentrate to a relative density of 1.25 (60°C) to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria root with 70% v / v ethanol under reflux twice, the first time for 1.5 h and the second time for 1.0 h. Combine the extracts and recover the ethanol to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 40 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0040] Comparative Example 5 The main difference between this comparative example and Example 1 is that the knotweed is replaced by salvia miltiorrhiza.

[0041] A pharmaceutical composition for lowering blood sugar comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of kudzu root, 8 parts of dandelion, 12 parts of epimedium, 10 parts of salvia miltiorrhiza, 7 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 4 parts of lycium bark.

[0042] The preparation method of the pharmaceutical composition comprises the following steps: (1) Pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark were added to 8 times the amount of purified water and decocted three times, the first time for 2.0 h, the second time for 1.5 h, and the third time for 1.0 h. Filter, combine the filtrates, and concentrate to a relative density of 1.25 (60°C) to obtain extract A. (2) Curcuma longa, Salvia miltiorrhiza, Schisandra chinensis, Dendrobium officinale, and Pueraria root were extracted with 70% v / v ethanol for two times, the first time for 1.5 h and the second time for 1.0 h. The extracts were combined and the ethanol was recovered to obtain extract B. (3) Loquat leaves and Inula flower are decocted together and then boiled separately for 40 minutes. The filtrate is filtered and collected to obtain the medicinal solution. (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the liquid medicine from step (3) to obtain the mixed raw material medicine, make pills, sterilize, and package.

[0043] Test example Healthy adult SD rats were selected with a male-to-female ratio of 1:1 and fed a high-fat diet for 8 weeks to induce diabetes modeling. A type 2 diabetes model was established by intraperitoneal injection of streptozotocin (STZ, 25 mg / kg). Model verification: tail vein blood samples were collected for 3 consecutive days and tested with a blood glucose meter. The model was considered successful when fasting blood glucose was ≥16.7 mmol / L.

[0044] The rats with successful modeling were randomly divided into: diabetic model group, treatment groups 1-8, and acarbose positive control group (α-glucosidase inhibitor). A normal control group was also set up for routine feeding during the same period. Among them, the acarbose positive control group: oral administration of acarbose 100 mg / (kg·d); Treatment groups 1-8: oral administration of 100 mg / (kg·d) of the pharmaceutical composition of Examples 1-3 and Comparative Examples 1-5, respectively; Dosage cycle: single dose per day for 10 days; Blood glucose monitoring: baseline value before administration and on the 10th day after administration.

[0045] After the experiment, the rats were anesthetized and the chest was opened. The pancreatic tissue was removed and placed in 30% sucrose for dehydration for 12 hours, then embedded in OCT embedding medium and stored at -80°C until use. The pancreatic tissue blocks were serially sectioned, and the slice thickness was strictly controlled at 7 μm. The tissue sections were incubated with 0.5% Triton-X100 at 25°C for 15 minutes, washed three times with PBS, and blocked with serum at 25°C for 30 minutes. Insulin and glucagon primary antibodies were then added and incubated at 4°C for 12 hours. Cells unbound to the primary antibody were washed with PBS, and fluorescent secondary antibodies were added. The sections were incubated at 25°C for 2 hours, nuclear dye was added for incubation for 10 minutes, and finally, the sections were sealed with 50% wt glycerol. Laser confocal microscopy was used to observe and collect images. 40-50 islets were randomly selected from each group, and the number of β cells was recorded and the average value was calculated.

[0046] Table 1 Blood glucose level results of each group

[0047] The results showed that compared with the model group, the blood glucose levels of Examples 1-3, Comparative Examples 1-5, and the acarbose group were significantly reduced (P<0.01). Among them, Example 1 had the best effect in lowering blood glucose.

[0048] Table 2 β-cell number results of each group

[0049] The results showed that compared with the normal group, the model group had a significant decrease in β-cell count (P < 0.01). Compared with the model group, the β-cell counts in Examples 1-3, Comparative Examples 1-5, and the acarbose group all increased significantly (P < 0.01). Compared with Examples 2-3, Example 1 showed the greatest effect in increasing β-cell count; however, the increase in β-cell count in Comparative Examples 1-5 was less than that in Example 1. This indicates that the addition of Gynostemma pentaphyllum, Pueraria root, Epimedium, and Polygonum cuspidatum to the present invention's formula significantly impacts its efficacy.

Claims

1. A pharmaceutical composition that helps lower blood sugar, characterized in that: The invention comprises the following raw materials in parts by weight: 15-20 parts of pomegranate, 8-13 parts of turmeric, 1-2 parts of bear bile, 1-2 parts of schisandra chinensis, 10-15 parts of dendrobium, 5-10 parts of loquat leaves, 8-12 parts of kudzu root, 5-10 parts of dandelion, 8-15 parts of epimedium, 8-12 parts of knotweed, 5-8 parts of gynostemma pentaphyllum, 4-8 parts of inula flower, and 3-5 parts of lycium bark.

2. The pharmaceutical composition for lowering blood sugar according to claim 1, characterized in that The invention comprises the following raw materials in parts by weight: 18 parts of pomegranate, 10 parts of turmeric, 1.5 parts of bear bile, 1.5 parts of schisandra chinensis, 13 parts of dendrobium, 8 parts of loquat leaves, 10 parts of kudzu root, 8 parts of dandelion, 12 parts of epimedium, 10 parts of knotweed, 7 parts of gynostemma pentaphyllum, 6 parts of inula flower, and 4 parts of lycium bark.

3. The pharmaceutical composition for lowering blood sugar according to claim 1 or 2, characterized in that: The preparation method of the pharmaceutical composition comprises the following steps: (1) Add 7-9 times the amount of water to pomegranate, dandelion, epimedium, Gynostemma pentaphyllum, and Lycium bark and boil for 2-3 times, each time for 1-2 hours. Filter, combine the filtrate, and concentrate to obtain extract A. (2) Extract turmeric, Polygonum cuspidatum, Schisandra chinensis, Dendrobium officinale, and Pueraria lobata with 70%-80% v / v ethanol under reflux for 2-3 times, each time for 1-1.5 hours. Combine the extracts and recover the ethanol to obtain extract B. (3) Decoction the loquat leaves and inula flower separately for 40-50 minutes, filter and obtain the medicinal solution; (4) Mix the bear bile with the extract A from step (1), then add the extract B from step (2), and finally add the medicinal solution from step (3) to obtain a mixed raw material drug, and prepare pills.

4. The pharmaceutical composition for lowering blood sugar according to claim 3, characterized in that In step (1), the concentration is specifically: concentrating at 55-65° C. to a relative density of 1.25-1.

30.

5. The pharmaceutical composition for lowering blood sugar according to claim 3, characterized in that In step (1), decoction was performed three times, the first time for 2 h, the second time for 1.5 h, and the third time for 1 h.

6. The pharmaceutical composition for lowering blood sugar according to claim 3, characterized in that In step (2), reflux extraction was performed twice, the first time for 1.5 h and the second time for 1.0 h.

7. A pharmaceutical preparation that helps lower blood sugar, characterized in that: The invention is prepared from the pharmaceutical composition for lowering blood sugar according to any one of claims 1 to 6.

8. Use of the pharmaceutical composition according to any one of claims 1 to 6 in the preparation of hypoglycemic drugs.

9. Use of the pharmaceutical composition according to any one of claims 1 to 6 in the preparation of a drug for treating diabetes.

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