Traditional Chinese medicine composition for treating diabetes and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating diabetes and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions. The invention solves the problem of limited curative effect in the existing diabetes treatment. The traditional Chinese medicine composition comprises the following components: 3-15 parts of ginseng; 10 to 30 parts of poria cocos; 5-30 parts of bighead atractylodes rhizome; 10 to 30 parts of radix achyranthis bidentatae; 10 to 30 parts of rhizoma alismatis; 10 to 30 parts of radix rehmanniae recen; 5-30 parts of coptis chinensis; 3 to 20 parts of cortex cinnamomi; 5-20 parts of dried ginger; 3 to 20 parts of fructus momordicae; 10 to 30 parts of corn stigma; 3-20 parts of lotus leaves; 10 to 30 parts of radix astragali seu hedysari; 10-20 parts of Chinese wolfberry fruits; 5 to 15 parts of radix scrophulariae; 5 to 15 parts of Chinese angelica; 5-10 parts of snow lotus herb; 5 to 10 parts of trogopterus dung; and 5-10 parts of pyrrosia lingua. The traditional Chinese medicine composition can be used for treating type 2 diabetes mellitus, has the functions of regulating blood sugar and enhancing body metabolism, and is remarkable in curative effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof. Background Art

[0002] Diabetes is a chronic metabolic disease characterized by high blood glucose levels, usually caused by insufficient insulin secretion or reduced cellular responsiveness to insulin (insulin resistance). Diabetes and its complications are important public health problems globally, severely affecting the quality of life and life expectancy of patients. According to data from the World Health Organization, the number of diabetes patients globally continues to increase, imposing a huge economic burden on individuals, families, and society.

[0003] Diabetes is mainly divided into type 1 diabetes, type 2 diabetes, gestational diabetes, and other special types of diabetes. Among them, type 2 diabetes is the most common, accounting for more than 90% of all diabetes cases. The pathogenesis of type 2 diabetes is complex and involves multiple factors such as genetics, environment, and lifestyle. Insulin resistance and pancreatic beta-cell dysfunction are the main links in the development of type 2 diabetes. In addition, obesity, lack of physical activity, and poor eating habits are also important factors inducing type 2 diabetes.

[0004] Currently, the treatment of diabetes mainly includes lifestyle intervention, oral hypoglycemic drugs, and insulin replacement therapy. Lifestyle intervention is the basis of diabetes management, including diet control, increased physical activity, etc. There are various types of oral hypoglycemic drugs, including sulfonylureas, biguanides, alpha-glucosidase inhibitors, thiazolidinediones, DPP-4 inhibitors, SGLT-2 inhibitors, etc., which improve blood glucose levels through different mechanisms. However, existing oral hypoglycemic drugs often have problems such as limited efficacy, more side effects, and decreased long-term application effects during the treatment process.

[0005] Insulin replacement therapy is one of the important means for treating diabetes, especially for insulin-dependent diabetes patients. However, insulin treatment requires strict control of the dose, and both overdose and underdose may lead to serious hypoglycemic or hyperglycemic events, resulting in limited treatment effects, and insulin injection brings inconvenience and pain to patients. Summary of the Invention

[0006] Aiming at the problem of limited efficacy in the treatment of diabetes in the prior art, the present invention provides a traditional Chinese medicine composition for treating diabetes and a preparation method thereof.

[0007] The technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition for treating diabetes, comprising the following components: Ginseng: 3 - 15 parts; Ginseng has significant effects in the treatment of diabetes. Its hypoglycemic effect is mainly achieved through components such as ginsenosides and ginseng polysaccharides. At the same time, ginseng can also improve insulin sensitivity and exert other multiple pharmacological effects. Specifically, ginsenosides are the key components of ginseng's hypoglycemic effect. Especially ginsenoside Re and Rb1, they can enhance the effect of insulin, playing an effect similar to insulin, thus reducing blood sugar. Experiments have confirmed that ginsenoside Re can significantly reduce the blood sugar level of experimental animals and at the same time improve the glucose tolerance ability. Ginseng polysaccharides have also been found to have a significant hypoglycemic effect. By constructing a type 2 diabetes mouse model and conducting experiments, the results show that ginseng polysaccharides can significantly reduce indicators such as fasting blood sugar and glycosylated hemoglobin in mice, and have good safety, indicating that ginseng polysaccharides have definite effects in the treatment of type 2 diabetes. Ginseng can not only directly reduce blood sugar, but also improve insulin sensitivity. This means that ginseng can help the body use insulin more effectively, thus better controlling blood sugar levels. This discovery provides a theoretical basis for the application of ginseng in the treatment of insulin resistance. In addition to its hypoglycemic effect, ginseng also has multiple pharmacological effects such as protecting kidney function and regulating lipid metabolism. These effects help to improve the overall health of diabetic patients and reduce the occurrence of complications.

[0008] Poria cocos: 10 - 30 parts; The polysaccharide components in Poria cocos can regulate blood sugar, helping to reduce the blood sugar level of diabetic patients. In addition, Poria cocos also contains flavonoids, which can enhance insulin signal transduction and increase insulin secretion, thus further promoting blood sugar reduction. Poria cocos can also improve insulin sensitivity. In addition to the direct blood sugar-lowering effect, Poria cocos also shows a preventive and therapeutic effect on diabetic complications. The polysaccharides and flavonoids in Poria cocos have antioxidant and anti-inflammatory effects, which may help prevent complications such as cardiovascular diseases, neuropathy, eye diseases, and kidney diseases caused by diabetes. For example, Poria cocos polysaccharides can reduce the levels of cholesterol and triglycerides, and alleviate the formation of atherosclerotic plaques, having a protective effect on the cardiovascular system. Poria cocos polysaccharides can effectively reduce the blood sugar, serum insulin, glucagon, total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) levels in diabetic model mice, while increasing the high-density lipoprotein cholesterol (HDL-C) level.

[0009] Atractylodes macrocephala: 5 - 30 parts; Atractylodes macrocephala can promote the secretion of insulin by pancreatic islet β cells and at the same time inhibit hepatic glucose output, thus helping to reduce the blood sugar level. Atractylodes macrocephala contains various active components such as volatile oils and polysaccharides, and these components may participate in the regulation of the body's physiological and pathological processes through different action pathways. Especially the polysaccharide component of Atractylodes macrocephala has been confirmed to have a significant hypoglycemic effect, and its mechanism is related to improving insulin sensitivity, promoting insulin secretion, and regulating the activity of sugar metabolism-related enzymes.

[0010] Achyranthes bidentata: 10 - 30 parts; The polysaccharide component in Achyranthes bidentata has a significant hypoglycemic effect. Achyranthes bidentata polysaccharide can reduce the blood glucose level of experimental animals. Its mechanism may be related to promoting insulin secretion, enhancing insulin sensitivity, and regulating the activity of enzymes related to glucose metabolism. Specifically, Achyranthes bidentata polysaccharide may stimulate pancreatic islet β cells to release insulin, while improving the sensitivity of peripheral tissues to insulin, improving insulin resistance, and enhancing the body's sensitivity to insulin, thus contributing to the control of blood glucose levels. The active ingredients in Achyranthes bidentata have antioxidant, anti-inflammatory and other effects, which may have positive significance for the prevention and treatment of these complications. For example, Achyranthes bidentata can reduce oxidative stress response and protect the cardiovascular system from damage.

[0011] Alisma orientale: 10 - 30 parts; Alisma orientale can play a hypoglycemic effect by increasing the body's uptake of glucose without increasing fat synthesis. The hypoglycemic effect of Alisma orientale is mainly attributed to its alcohol-soluble and water-soluble components, especially the alcohol-soluble components, which have obvious curative effects on diabetes and its complications. These components can regulate glucose metabolism disorders and achieve hypoglycemic effects. In addition to its hypoglycemic effect, Alisma orientale also has multiple pharmacological effects such as diuresis, anti-inflammatory and lipid regulation. These effects help to improve the overall health of diabetic patients and reduce the occurrence of complications.

[0012] Rehmannia glutinosa: 10 - 30 parts; Rehmannia glutinosa has been proven to have a hypoglycemic effect and is suitable for diabetic patients. Its hypoglycemic mechanism mainly includes promoting insulin secretion and enhancing insulin sensitivity, improving insulin resistance, and controlling blood glucose. Certain components in Rehmannia glutinosa, such as flavonoids and polysaccharides, have antioxidant activity, can scavenge free radicals in the body, reduce oxidative stress response, thus protecting pancreatic islet cells from damage and maintaining normal insulin secretion function. Rehmannia glutinosa can reduce the activity of hepatic glucose-6-phosphatase, which helps to regulate the conversion of glucose into ATP, provide energy for the human body, and also helps to control blood glucose levels. Multiple active ingredients in Rehmannia glutinosa have anti-inflammatory effects, can inhibit inflammatory reactions, reduce tissue damage and the occurrence of complications caused by diabetes. In addition, it can also improve lipid metabolism disorders and renal function, further reducing the risk of diabetes-related complications. Rehmannia glutinosa contains rich chemical components such as iridoid glycosides, phenyl ethanol glycosides, flavonoids and polysaccharides. Among them, iridoid glycosides and phenyl ethanol glycosides are regarded as the main active ingredients, which regulate blood glucose through multiple mechanisms and show significant antioxidant and anti-inflammatory effects.

[0013] Coptis chinensis: 5 - 30 parts; Coptis chinensis shows significant hypoglycemic effects. For example, the water extract of Coptis chinensis can significantly reduce the blood glucose level in diabetic animal models. This effect may be related to the active ingredients such as berberine contained in Coptis chinensis. Coptis chinensis may regulate blood glucose levels through multiple pathways, including reducing hepatic glycogen production, increasing insulin sensitivity, and decreasing intestinal glucose absorption. These mechanisms work together to make Coptis chinensis have significant effects in the treatment of diabetes. In addition to the direct hypoglycemic effect, Coptis chinensis also shows preventive and therapeutic effects on diabetes-related complications. For example, the antioxidant and anti-inflammatory effects of Coptis chinensis can help reduce the oxidative stress and inflammatory responses caused by diabetes, thereby protecting pancreatic islet cells and tissues from damage. Coptis chinensis can also regulate the intestinal flora, increase the number of beneficial bacteria, and reduce the growth of harmful bacteria, thereby improving the gastrointestinal problems of diabetic patients and possibly having a positive impact on mechanisms such as insulin secretion and hepatic glycogen synthesis.

[0014] Cinnamon: 3 - 20 parts; The active ingredients in cinnamon, such as cinnamic acid and cinnamaldehyde, can increase insulin sensitivity, promote glucose uptake and utilization, and thus reduce blood glucose levels. Cinnamon may also further improve insulin sensitivity and achieve hypoglycemic effects by activating certain insulin pathways, such as the TRPA1-Ca2+ pathway. After administering different doses of cinnamon active ingredients, the plasma glucose concentration of experimental animals decreased significantly in a dose-dependent manner. It can be used as an oral drug or added to food to help control blood glucose levels and reduce the risk of complications caused by diabetes.

[0015] Dry ginger: 5 - 20 parts; Dry ginger contains various active ingredients such as gingerol and curcumin, and these ingredients have been found to have therapeutic effects on diabetes. Gingerol has been proven to have a protective effect on pancreatic β-cells and can promote the recovery of plasma insulin levels, which is crucial for diabetic patients. The polysaccharide component in dry ginger can effectively improve the composition of the intestinal flora in diabetic mice and increase the abundance of probiotics such as Lactobacillus. This positive effect on the intestinal flora helps to reduce blood glucose levels. Dry ginger has significant antioxidant and anti-inflammatory effects, which are very important for alleviating the oxidative stress and inflammatory responses caused by diabetes. By reducing inflammation and oxidative stress, dry ginger helps to protect pancreatic islet cells from further damage.

[0016] Momordica grosvenori: 3 - 20 parts; Momordica grosvenori has shown significant efficacy in the modern medical and pharmacological research of diabetes and its complications. Studies have found that the mogrosides in Momordica grosvenori can inhibit the activity of α-glucosidase, delay the digestion and absorption of carbohydrates, and thus effectively reduce fasting blood glucose and postprandial blood glucose levels. In addition, Momordica grosvenori also plays a hypoglycemic role through multiple pathways such as promoting insulin secretion, increasing insulin receptor sensitivity, and improving insulin resistance. Besides the direct hypoglycemic effect, Momordica grosvenori also shows an improvement effect on diabetes complications. Its active ingredients such as flavonoids and polysaccharides have functions such as reducing blood lipids, antioxidation, and anti-inflammation, which help to alleviate cardiovascular, kidney, and nerve complications caused by diabetes. At the same time, Momordica grosvenori can also protect pancreatic islet β cells from damage, promote insulin secretion, and further improve the condition of diabetes.

[0017] Corn silk: 10 - 30 parts; Corn silk has a significant hypoglycemic effect. Its active ingredients, such as polysaccharides and flavonoids, can inhibit the activity of α-glucosidase, delay the digestion and absorption of carbohydrates, and thus reduce the sharp rise in postprandial blood glucose. In addition, corn silk extract can also increase the sensitivity of insulin receptors, promote the utilization of glucose, and further reduce blood glucose levels. Corn silk also has a blood lipid-lowering effect. Its flavonoid and polysaccharide components can regulate lipid metabolism, reduce total cholesterol, triglyceride, and low-density lipoprotein cholesterol levels, while increasing high-density lipoprotein cholesterol levels, which helps to prevent the occurrence of atherosclerosis. Corn silk is rich in antioxidants such as flavonoids and polyphenols, which can effectively scavenge free radicals in the body and reduce the damage of oxidative stress to cells. At the same time, it can also inhibit the production and release of inflammatory factors, has an anti-inflammatory effect, and has a protective effect on diabetes and its cardiovascular complications. In addition, the diuretic effect of corn silk helps to promote the excretion of excess water and toxins in the body, reduce the burden on the kidneys, and has a certain preventive and therapeutic effect on diabetic nephropathy. Its antifibrotic effect can also inhibit the occurrence and development of renal fibrosis and further protect renal function. Certain components in corn silk can dilate blood vessels, increase blood flow, and improve microcirculation disorders, and have potential therapeutic effects on microvascular complications such as peripheral neuropathy and retinopathy caused by diabetes.

[0018] Lotus leaf: 3 - 20 parts; Active ingredients such as alkaloids and flavonoids in lotus leaves can inhibit the activity of α-glucosidase, delay the hydrolysis of carbohydrates and the absorption of glucose, thereby effectively controlling postprandial blood glucose levels. At the same time, these ingredients can also promote insulin sensitivity, improve the insulin resistance state, and further reduce blood glucose. In addition, lotus leaves also have the effect of regulating blood lipids, can inhibit fat synthesis and accumulation, promote fat decomposition, help reduce the levels of serum total cholesterol, triglycerides and low-density lipoprotein cholesterol, and increase the level of high-density lipoprotein cholesterol, which has positive significance for the prevention of cardiovascular diseases. The antioxidant and anti-inflammatory effects of lotus leaves cannot be ignored: scavenging free radicals, reducing the damage of oxidative stress to tissues, and inhibiting inflammatory reactions, thereby protecting pancreatic islet β cells and other tissues from damage. These mechanisms of action together provide a scientific basis for the application of lotus leaves in the treatment of diabetes, especially showing potential therapeutic value in preventing or delaying diabetic cardiovascular complications, kidney complications, and retinal complications, etc.

[0019] Astragalus membranaceus: 10 - 30 parts; In recent years, Astragalus membranaceus has shown significant pharmacological activities in the treatment of diabetes and its complications. Astragalus polysaccharide is one of the main active ingredients of Astragalus membranaceus, with various effects such as hypoglycemic, improving insulin resistance, antioxidant and anti-inflammatory. Hypoglycemic effect: Astragalus polysaccharide can significantly reduce the blood glucose level of experimental diabetic animals, and its mechanism of action may be related to promoting insulin secretion and improving insulin resistance. Research shows that Astragalus polysaccharide can increase the synthesis of liver glycogen and reduce the decomposition of liver glycogen, thereby reducing blood glucose. Improving insulin resistance: Astragalus polysaccharide can improve insulin sensitivity and the insulin resistance state. It can regulate the insulin signal transduction pathway, increase the expression of GLUT4 transporter, and promote the uptake and utilization of glucose. Antioxidant and anti-inflammatory effects: Astragalus polysaccharide has significant antioxidant and anti-inflammatory activities, can scavenge free radicals, reduce oxidative stress damage, inhibit inflammatory reactions, thereby protecting the function of pancreatic islet β cells and delaying the development of diabetes and its complications.

[0020] Lycium barbarum: 10 - 20 parts; Lycium barbarum is rich in various bioactive ingredients such as Lycium barbarum polysaccharide, betaine, carotenoids, etc., and these ingredients show potential pharmacological effects in the treatment of diabetes. Hypoglycemic effect: Lycium barbarum polysaccharide is the main hypoglycemic component of Lycium barbarum, and can significantly reduce the blood glucose level of experimental diabetic animals. Its mechanism of action may be related to promoting insulin secretion, improving insulin resistance, increasing the synthesis of liver glycogen, etc. Antioxidant effect: Lycium barbarum polysaccharide has strong antioxidant activity, can scavenge free radicals, reduce the damage of oxidative stress to pancreatic islet β cells, and protect pancreatic islet function. Regulating lipid metabolism: Lycium barbarum polysaccharide can also regulate lipid metabolism, reduce blood lipid levels, and prevent the occurrence of diabetic cardiovascular complications.

[0021] Scrophularia ningpoensis Hemsl.: 5 - 15 parts; The iridoid glycosides in Scrophularia ningpoensis Hemsl. have various pharmacological effects such as hypoglycemic, anti - inflammatory, and antioxidant effects. Hypoglycemic effect: The extract of Scrophularia ningpoensis Hemsl. can significantly reduce the blood glucose level of experimental diabetic animals, and its mechanism may be related to promoting insulin secretion, improving insulin resistance, increasing glucose utilization, etc. Anti - inflammatory effect: The iridoid glycosides in Scrophularia ningpoensis Hemsl. have significant anti - inflammatory activity, can inhibit the inflammatory response, and reduce tissue damage caused by diabetes. Antioxidant effect: The extract of Scrophularia ningpoensis Hemsl. can also scavenge free radicals, reduce the damage of oxidative stress to cells, and protect the function of pancreatic islet β - cells.

[0022] Angelica sinensis (Oliv.) Diels: 5 - 15 parts.

[0023] Angelica polysaccharide is one of the main active components of Angelica sinensis (Oliv.) Diels, and has various pharmacological effects such as hypoglycemic, antioxidant, and anti - inflammatory effects. Hypoglycemic effect: Angelica polysaccharide can significantly reduce the blood glucose level of experimental diabetic animals, and its mechanism of action may be related to promoting insulin secretion, improving insulin resistance, increasing glucose utilization, etc. Antioxidant effect: Angelica polysaccharide has strong antioxidant activity, can scavenge free radicals, reduce the damage of oxidative stress to pancreatic islet β - cells, and protect pancreatic islet function. Immunomodulatory function: Angelica polysaccharide can also regulate the immune function, enhance the body's resistance, and prevent the occurrence of diabetic complications.

[0024] Saussurea involucrata Kar. et Kir.: 5 - 10 parts; Modern scientific research has proved that Saussurea involucrata Kar. et Kir. contains various beneficial components for human body functions, such as flavonoids, alkaloids, etc., and these components may play an important role in diabetes management. Some components in Saussurea involucrata Kar. et Kir., such as flavonoids, can reduce the blood glucose level and have a certain adjuvant therapeutic effect on diabetic patients. Saussurea involucrata Kar. et Kir. contains rich antioxidant substances, can scavenge free radicals, reduce the damage of oxidative stress to pancreatic islet β - cells, and thus protect pancreatic islet function. The polysaccharides and various bioactive substances in Saussurea involucrata Kar. et Kir. can stimulate and regulate the function of the human immune system, enhance the body's resistance to diseases, which helps diabetic patients prevent complications such as infections.

[0025] Trogopterus dungarensis (P. - L. Geoffroy): 5 - 10 parts; Although the direct research on Trogopterus dungarensis (P. - L. Geoffroy) in diabetes is relatively less, its effects of promoting blood circulation to remove blood stasis and stopping bleeding may have potential value in the treatment of diabetic complications. Trogopterus dungarensis (P. - L. Geoffroy) has the effects of promoting fibrinolytic and increasing coronary blood flow, which helps to improve the microcirculation disorder of diabetic patients and reduce the occurrence of complications such as diabetic foot and diabetic retinopathy. The anti - inflammatory effect of Trogopterus dungarensis (P. - L. Geoffroy) may help to reduce the inflammatory response in diabetic patients, thus protecting pancreatic islet β - cells and other tissues and organs from inflammatory damage.

[0026] Pyrrosia lingua (Thunb.) Farw.: 5 - 10 parts.

[0027] Modern research shows that Pyrrosia lingua contains flavonoids, polysaccharides and other active ingredients, and these ingredients exhibit certain pharmacological effects in diabetes management. Pyrrosia lingua polysaccharide can significantly reduce the fasting blood glucose concentration of alloxan-induced diabetic mice and the blood glucose concentration after intragastric administration of glucose, showing good hypoglycemic effects. The flavonoids in Pyrrosia lingua have good antioxidant properties, can scavenge free radicals, reduce the damage of oxidative stress to pancreatic islet β cells, and thus protect pancreatic islet function. The antibacterial effect of Pyrrosia lingua may help diabetic patients prevent complications such as infections.

[0028] A preparation method of a traditional Chinese medicine composition for treating diabetes comprises the following steps: Step 1: Prepare raw materials according to the required traditional Chinese medicine raw materials and their ratios; Step 2: Soak the prepared raw materials; Step 3: Decoct the raw materials and the soaking solution together for several times; Step 4: Combine and concentrate the medicinal liquids obtained from several times of decoction to obtain a concentrated medicinal liquid; Step 5: Prepare the obtained concentrated medicinal liquid into a preparation Preferably, the weight of the soaking solution added during soaking in Step 2 is 10 times the total weight of the raw materials, and the soaking time is 30 minutes.

[0029] Preferably, in Step 3, first use strong fire to boil the raw materials and the soaking solution, then change the strong fire to slow fire and continue to decoct, and the decocting time for each time is 1 hour; after the decocting is completed, separate the medicinal liquid and the medicinal residues, and add water to the medicinal residues for the next decocting.

[0030] Preferably, the preparation in Step 5 is oral liquid, granule or tablet.

[0031] In summary, due to the adoption of the above technical solutions, the beneficial effects of the present invention are: 1. The present invention provides a traditional Chinese medicine composition that can be used to treat type 2 diabetes and has the functions of regulating blood glucose and enhancing the body's metabolic function, providing a new option for the clinical treatment of diabetes. This traditional Chinese medicine composition can improve insulin resistance and promote the recovery of pancreatic islet β cell function through the synergistic effect of multiple components, so as to achieve the purpose of reducing blood glucose and delaying the occurrence of diabetic complications.

[0032] 2. The traditional Chinese medicine composition provided by the present invention realizes the comprehensive effects of multiple components, multiple targets and multiple pathways through scientific compatibility of multiple traditional Chinese medicine components, has significant hypoglycemic effects, can better regulate the body function, improve insulin resistance, and promote the recovery of pancreatic islet β cell function.

[0033] 3. The traditional Chinese medicine composition provided by the present invention not only has good hypoglycemic effects, but also can improve the general symptoms of diabetic patients, which is beneficial to the overall recovery of patients.

[0034] 4. The traditional Chinese medicine composition provided by the present invention has remarkable curative effects and broad application prospects, and is expected to bring gospel to more diabetic patients. Detailed implementation manners

[0035] To make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions of the present application will be clearly and completely described below in conjunction with the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments.

[0036] Embodiment 1 A traditional Chinese medicine composition for treating diabetes, comprising the following components: Ginseng: 15 g; Poria cocos: 20 g; Atractylodes macrocephala: 20 g; Achyranthes bidentata: 10 g; Alisma orientale: 10 g; Rehmannia glutinosa: 10 g; Coptis chinensis: 15 g; Cinnamomum cassia: 10 g; Dry ginger: 10 g; Momordica grosvenori: 5 g; Corn silk: 10 g; Lotus leaf: 5 g; Astragalus membranaceus: 15 g; Lycium barbarum: 15 g; Scrophularia ningpoensis: 10 g; Angelica sinensis: 10 g; Saussurea involucrata: 5 g; Trogopterus dung: 5 g; Pyrrosia lingua: 5 g.

[0037] The interaction mechanism among the components is analyzed from the perspective of the components as follows: 1. Ginseng Core function: As the monarch drug, ginseng plays a leading role in the whole formula. Its main components, ginsenosides and ginseng polysaccharides, have significant effects in reducing blood sugar and improving insulin sensitivity.

[0038] With Poria cocos and Atractylodes macrocephala: Ginseng enhances the function of the spleen and stomach, promotes digestion and absorption, and provides a better environment for the diuretic and dampness-promoting effects of Poria cocos and Atractylodes macrocephala. This synergistic effect helps to improve the abnormal glucose metabolism and edema symptoms caused by spleen and stomach weakness in diabetic patients.

[0039] With Coptis chinensis, Rehmannia glutinosa, and Panax ginseng: The function of promoting fluid production and nourishing blood of Panax ginseng is closely related to the generation of body fluid in the human body. Rehmannia glutinosa and Coptis chinensis regulate the internal heat condition in the body by clearing heat and cooling blood, and clearing heat and drying dampness respectively. The combination of the three helps to balance yin and yang in the body, relieve the internal heat symptoms of diabetic patients, and promote the secretion and utilization of insulin.

[0040] 2. Poria Core function: The function of promoting diuresis and percolating dampness of Poria is crucial for relieving edema in diabetic patients. Its polysaccharides and flavonoids can also regulate blood sugar and enhance insulin signal transduction.

[0041] With Panax ginseng and Atractylodes macrocephala: The synergistic effect of Poria with these two herbs is not limited to strengthening the spleen and promoting diuresis to eliminate dampness, but also can promote the excretion of dampness in the body and relieve the sugar metabolism disorder caused by the accumulation of dampness pathogen.

[0042] With Alisma orientale: Poria and Alisma orientale have similar effects in promoting diuresis. The combined use of the two can significantly enhance the diuretic effect, accelerate the excretion of excess water in the body, and thus relieve edema and microcirculation disorders.

[0043] 3. Atractylodes macrocephala Core function: Atractylodes macrocephala not only invigorates the spleen and benefits qi, but also dries dampness and promotes diuresis, and has a significant curative effect on the common symptoms of spleen deficiency and dampness entrapment in diabetic patients. Its polysaccharide component regulates blood sugar by increasing insulin sensitivity and promoting insulin secretion and other ways.

[0044] With Poria and Panax ginseng: The three together build a powerful spleen-strengthening system, enhance the transportation and transformation function of the spleen and stomach, provide sufficient nutritional support for the body, and help improve sugar metabolism.

[0045] With Achyranthes bidentata: The dampness-drying effect of Atractylodes macrocephala combined with the effect of promoting diuresis and relieving stranguria of Achyranthes bidentata helps to remove dampness in the body and improve the symptoms of limb heaviness and edema in diabetic patients.

[0046] 4. Achyranthes bidentata Core function: The function of tonifying the liver and kidney and strengthening the tendons and bones of Achyranthes bidentata has a significant improvement effect on the weakness and fatigue caused by osteoporosis and muscle atrophy in diabetic patients. Its polysaccharide component can also promote insulin secretion and increase insulin sensitivity.

[0047] With Poria and Alisma orientale: The three work synergistically to accelerate the excretion of excess water in the body, and help improve the microcirculation and edema symptoms in diabetic patients.

[0048] With Rehmannia glutinosa and Cinnamomum cassia: The combination of Achyranthes bidentata with Rehmannia glutinosa and Cinnamomum cassia can not only tonify the liver and kidney, nourish yin and promote fluid production, but also warm yang and dispel cold, regulate the balance of yin and yang in the body, and have a positive impact on the general symptoms of diabetic patients.

[0049] 5. Alisma orientale Core function: Alisma orientale helps diabetic patients excrete excess water in the body and relieve edema through its diuretic and dampness-promoting effects. Its alcohol-soluble and water-soluble components have obvious curative effects on diabetes and its complications.

[0050] With Poria cocos and Achyranthes bidentata: The three work together to exert a powerful diuretic effect, improving the body fluid circulation and metabolic state of diabetic patients.

[0051] With Coptis chinensis: The lipid-lowering and turbidity-removing effect of Alisma orientale combines with the heat-clearing and dampness-drying effect of Coptis chinensis, helping to regulate blood lipids and prevent the occurrence of diabetic cardiovascular diseases.

[0052] 6. Rehmannia glutinosa Core function: Rehmannia glutinosa has the effects of clearing heat and cooling blood, and nourishing yin and promoting fluid production, and has significant curative effects on the symptoms of yin deficiency and excessive fire in diabetic patients. Its various active components such as flavonoids and polysaccharides have antioxidant and anti-inflammatory effects.

[0053] With Coptis chinensis: The two work together to clear heat, reducing the internal heat symptoms of diabetic patients, and at the same time protecting pancreatic islet cells from damage.

[0054] With Cinnamomum cassia: The combination of the yin-nourishing and fluid-producing effect of Rehmannia glutinosa and the yang-warming and cold-dispersing effect of Cinnamomum cassia helps to regulate the yin-yang balance of the body and improve the general symptoms of diabetic patients.

[0055] 7. Coptis chinensis Core function: Coptis chinensis helps to relieve the symptoms of internal accumulation of heat-toxicity in diabetic patients through its effects of clearing heat and drying dampness, and purging fire and detoxifying. Its active components such as berberine can significantly reduce blood sugar levels.

[0056] With Rehmannia glutinosa: The two work together to clear heat, jointly regulate the internal heat condition in the body, and relieve symptoms such as thirst and excessive drinking in diabetic patients.

[0057] With Cinnamomum cassia and Zingiber officinale: The heat-clearing effect of Coptis chinensis and the yang-warming and cold-dispersing effects of Cinnamomum cassia and Zingiber officinale restrict each other, avoiding the drawbacks of excessive heat-clearing or excessive warming and tonifying, and maintaining the stability of the internal environment of the body.

[0058] 8. Cinnamomum cassia Core function: Cinnamomum cassia helps to improve the symptoms of yang deficiency and internal cold in diabetic patients through its effects of tonifying fire and assisting yang, and dispersing cold and relieving pain. Its active components such as cinnamic acid and cinnamolin can increase insulin sensitivity.

[0059] With Zingiber officinale: The two work together to warm the middle-jiao and disperse cold, enhancing the function of the spleen and stomach, promoting the circulation of qi and blood, and providing sufficient nutritional support for all organs of the body.

[0060] With Coptis chinensis: The yang-warming effect of Cinnamomum cassia restricts the cold nature of Coptis chinensis, protecting the spleen and stomach from damage, and at the same time promoting the mild exertion of the medicinal effect of Coptis chinensis.

[0061] 9. Zingiber officinale Core function: Ginger dried improves the symptoms of spleen and stomach deficiency-cold in diabetic patients through its functions of warming the middle-jiao to dispel cold and restoring yang to promote blood circulation. Its components such as gingerol have a protective effect on pancreatic β-cells.

[0062] With cinnamon: The two work synergistically to enhance the effect of warming the middle-jiao to dispel cold, and help improve the overall deficiency-cold state of diabetic patients.

[0063] With Coptis chinensis: The warm nature of ginger dried neutralizes the cold nature of Coptis chinensis, making the whole formula more mild and reducing the occurrence of side effects.

[0064] 10. Momordica grosvenori Core function: Momordica grosvenori promotes the production of body fluid to quench thirst and effectively relieves the thirst symptoms of patients with consumptive thirst. This is of great significance for improving the quality of life of patients. The components in Momordica grosvenori have been confirmed by modern pharmacological studies to have hypoglycemic effects.

[0065] With Coptis chinensis: The function of promoting the production of body fluid to quench thirst of Momordica grosvenori and the function of clearing heat and purging fire of Coptis chinensis complement each other, and jointly improve the heat syndrome state of patients with consumptive thirst, such as dry mouth and bitter taste.

[0066] With cinnamon: The yang-warming function of cinnamon and the function of promoting the production of body fluid to quench thirst of Momordica grosvenori cooperate to help balance yin and yang in the body and improve the overall condition of patients.

[0067] 11. Corn silk Core function: Corn silk has a significant diuretic effect, which can promote the excretion of excess water in the body, thus alleviating the edema symptoms of patients with consumptive thirst due to water metabolism disorders. Corn silk has a hypoglycemic effect, which helps control the blood sugar level of patients with consumptive thirst and prevent the occurrence of complications.

[0068] With Poria cocos: When used in combination, corn silk and Poria cocos can enhance the diuretic and detumescence effect and improve the edema symptoms of patients.

[0069] With Alisma orientale: When combined, corn silk and Alisma orientale can further enhance the diuretic effect and promote the excretion of dampness in the body, helping to improve the water metabolism disorders of patients with consumptive thirst.

[0070] 12. Lotus leaf Core function: Lotus leaf relieves the restlessness, thirst and other symptoms of patients with consumptive thirst due to yin deficiency and fire hyperactivity, improves the abnormal blood lipid metabolism of patients with consumptive thirst, and prevents the occurrence of complications such as diabetic cardiovascular diseases.

[0071] Compatibility with Rehmannia glutinosa: When used in combination, lotus leaf and Rehmannia glutinosa can balance yin and yang in the body, nourish yin and moisten dryness, and improve the symptoms of yin deficiency and fire hyperactivity of patients with consumptive thirst.

[0072] 13. Astragalus membranaceus Core function: Astragalus membranaceus is an important herb for replenishing qi in the formula. It is mainly responsible for enhancing the body's immunity and improving symptoms of qi deficiency, such as fatigue and spontaneous sweating. In the treatment of diabetes mellitus, Astragalus membranaceus helps lower blood sugar levels by replenishing qi and strengthening the superficial resistance, thereby improving the body's ability to utilize sugar.

[0073] Compatibility with Lycium barbarum: The qi-replenishing effect of Astragalus membranaceus combined with the liver and kidney tonifying effect of Lycium barbarum can enhance the overall function of the body and improve disease resistance.

[0074] Compatibility with Scrophularia ningpoensis: The qi-replenishing and superficial resistance strengthening effect of Astragalus membranaceus and the heat-clearing and blood-cooling effect of Scrophularia ningpoensis complement each other. They can not only replenish qi but also clear heat, helping to regulate the balance of yin and yang in the body.

[0075] Compatibility with Angelica sinensis: The qi-replenishing effect of Astragalus membranaceus combined with the blood-tonifying and blood-activating effect of Angelica sinensis can improve the state of qi and blood deficiency and promote the recovery of the body.

[0076] 14. Lycium barbarum Core function: Lycium barbarum is mainly responsible for tonifying the liver and kidney and improving eyesight. It has a significant effect on improving the symptoms of diabetes mellitus caused by liver and kidney yin deficiency. At the same time, the polysaccharide component in Lycium barbarum has a blood sugar-lowering effect, which can assist in controlling blood sugar levels.

[0077] Compatibility with Astragalus membranaceus: As mentioned above, the combination of Lycium barbarum and Astragalus membranaceus can enhance the overall function of the body and improve disease resistance.

[0078] Compatibility with Scrophularia ningpoensis: The liver and kidney tonifying effect of Lycium barbarum combined with the heat-clearing and blood-cooling effect of Scrophularia ningpoensis can regulate the balance of yin and yang in the body and improve the symptoms of excessive fire due to yin deficiency in patients with diabetes mellitus.

[0079] Compatibility with Angelica sinensis: The liver and kidney tonifying effect of Lycium barbarum combined with the blood-tonifying and blood-activating effect of Angelica sinensis can improve the state of qi and blood deficiency and promote the recovery of the body.

[0080] 15. Scrophularia ningpoensis Core function: Scrophularia ningpoensis is mainly responsible for clearing heat and cooling blood, nourishing yin and reducing fire. It has a significant effect on improving the symptoms of diabetes mellitus caused by excessive fire due to yin deficiency. At the same time, Scrophularia ningpoensis also has the effect of detoxifying and dissipating nodules, which can eliminate heat toxins and stasis in the body.

[0081] Compatibility with Astragalus membranaceus: As mentioned above, the combination of Scrophularia ningpoensis and Astragalus membranaceus can regulate the balance of yin and yang in the body and enhance the overall function of the body.

[0082] Compatibility with Lycium barbarum: As mentioned above, the combination of Scrophularia ningpoensis and Lycium barbarum can regulate the balance of yin and yang in the body and improve the symptoms of excessive fire due to yin deficiency in patients with diabetes mellitus.

[0083] Compatibility with Angelica sinensis: The heat-clearing and blood-cooling effect of Scrophularia ningpoensis combined with the blood-tonifying and blood-activating effect of Angelica sinensis can improve the symptoms of diabetes mellitus caused by heat toxin stasis.

[0084] 16. Angelica sinensis Core functions: Angelica sinensis is mainly responsible for enriching blood and promoting blood circulation, regulating menstruation and relieving pain. It has a significant effect on improving the symptoms of diabetes mellitus caused by deficiency of both qi and blood. At the same time, Angelica sinensis also has the effect of moistening the intestines and relieving constipation, and can relieve the constipation symptoms caused by yin deficiency and internal heat in patients with diabetes mellitus.

[0085] Compatibility with Astragalus membranaceus: As mentioned above, the combination of Angelica sinensis and Astragalus membranaceus can improve the state of deficiency of both qi and blood and promote the recovery of the body.

[0086] Compatibility with Lycium barbarum: As mentioned above, the combination of Angelica sinensis and Lycium barbarum can improve the state of deficiency of both qi and blood and enhance the disease resistance of the body.

[0087] Compatibility with Scrophularia ningpoensis: As mentioned above, the combination of the blood-enriching and blood-activating effect of Angelica sinensis and the heat-clearing and blood-cooling effect of Scrophularia ningpoensis can improve the symptoms of diabetes mellitus caused by heat-toxicity and stasis of blood.

[0088] 17. Saussurea involucrata Core functions: Saussurea involucrata is warm in nature and can warm and tonify the kidney yang. It has an improving effect on symptoms such as soreness and weakness of the waist and knees, and fear of cold and cold limbs in patients with diabetes mellitus caused by deficiency of kidney yang. Sufficient kidney yang helps the spleen yang to transport and transform, promotes the transformation and utilization of water essence and grains, and indirectly regulates blood sugar levels.

[0089] Compatibility with Panax ginseng and Astragalus membranaceus: It enhances the effect of supplementing qi and boosting yang, jointly improves the vital qi of the body, and counteracts the weak state caused by diabetes mellitus.

[0090] Compatibility with Rehmannia glutinosa and Coptis chinensis: Rehmannia glutinosa nourishes yin and tonifies the kidney, Coptis chinensis clears heat and dries dampness. Combined with the kidney-yang-warming effect of Saussurea involucrata, it forms a balance between yin and yang, which is beneficial to regulating endocrine and stabilizing blood sugar.

[0091] 18. Trogopterus dung Core functions: Trogopterus dung can promote blood circulation and remove blood stasis. It has a significant improving effect on blood stasis syndrome caused by diabetes mellitus (such as limb numbness, pain, etc.). By promoting blood circulation, it reduces the impact of blood stasis on pancreatic islet function and indirectly regulates blood sugar. For symptoms such as neuralgia and arthralgia caused by diabetes mellitus, Trogopterus dung has a good analgesic effect and improves the comfort of patients.

[0092] Compatibility with Angelica sinensis and Salvia miltiorrhiza: Angelica sinensis and Salvia miltiorrhiza are both herbs for promoting blood circulation and removing blood stasis. When used together with Trogopterus dung, they can enhance the effect of promoting blood circulation and removing blood stasis, accelerate metabolism, and contribute to blood sugar stability.

[0093] Compatibility with Coptis chinensis and Rehmannia glutinosa: Coptis chinensis clears heat and dries dampness, Rehmannia glutinosa nourishes yin and tonifies the kidney. Combined with the blood-activating and stasis-removing effect of Trogopterus dung, they jointly regulate the balance of yin and yang in the body and improve the symptoms of diabetes mellitus.

[0094] 19. Pyrrosia lingua Core functions: Pyrrosia lingua has a significant diuretic effect, which can increase urine output, help excrete excess sugar and toxins in the body, reduce the burden on the kidneys, and improve symptoms such as polyuria and edema caused by diabetes insipidus. The heat-clearing and detoxifying effect of Pyrrosia lingua helps to clear heat toxins in the body and improve the heat symptoms of diabetes patients, such as thirst and excessive drinking.

[0095] Compatibility with corn silk and alisma orientale: Both corn silk and alisma orientale are diuretic and dampness-promoting herbs. When combined with Pyrrosia lingua, they can significantly enhance the diuretic effect, accelerate the excretion of excess water in the body, and are beneficial for blood sugar control.

[0096] Compatibility with coptis chinensis and rehmannia glutinosa: Coptis chinensis clears heat and dries dampness, and rehmannia glutinosa nourishes yin and tonifies the kidney. Combined with the diuretic and stranguria-relieving effect of Pyrrosia lingua, they clear heat and tonify simultaneously, and jointly regulate the balance of body fluid metabolism and sugar metabolism.

[0097] The mechanism of action of the interaction between each component is analyzed from the efficacy as follows: 1. Hypoglycemic central effect of ginseng: As the monarch drug, ginseng contains components such as ginsenoside Re and Rb1, which not only enhance insulin sensitivity but also mimic the action of insulin to lower blood sugar. The various pharmacological effects of ginseng provide a basis for strengthening the body and improving metabolic efficiency for the whole formula.

[0098] 2. Spleen-strengthening and dampness-removing effect: Poria cocos, astragalus membranaceus, and atractylodes macrocephala all have the effect of strengthening the spleen. However, Poria cocos is more focused on promoting diuresis and removing dampness, while atractylodes macrocephala can dry dampness and promote diuresis while strengthening the spleen. Pyrrosia lingua also has the effect of promoting diuresis and relieving stranguria. When combined with Poria cocos and atractylodes macrocephala, it can more comprehensively improve symptoms caused by spleen deficiency and dampness obstruction, such as edema and fatigue.

[0099] 3. Diuretic and kidney-tonifying effect: Achyranthes bidentata, alisma orientale, corn silk, and lotus leaf all have the effect of promoting diuresis. In diabetic nephropathy, this synergistic diuretic effect promotes the balance of body fluid metabolism in the body, helps reduce the burden on the kidneys, and protects kidney function. The diuretic effect of Pyrrosia lingua can also play an auxiliary role in this link to enhance the effect of promoting diuresis and tonifying the kidney.

[0100] 4. Heat-clearing and yin-nourishing effect: Rehmannia glutinosa nourishes yin and generates fluid, coptis chinensis clears heat and dries dampness, scrophularia ningpoensis nourishes yin and reduces fire, momordica grosvenori clears heat and moistens the lungs, promotes fluid production and quenches thirst, and saussurea involucrata can clear heat and reduce swelling. When combined, on the one hand, it supplements the body fluids consumed by diabetes patients due to high blood sugar, and on the other hand, it clears the internal heat caused by yin deficiency in the body, jointly maintaining the balance of yin and yang in the body.

[0101] 5. Yang-warming and cold-dispersing effect: The yang-warming effects of cinnamon and dried ginger help improve symptoms such as cold extremities and fear of cold that often occur in diabetic patients. The effect of cinnamon in warming and dredging meridians combined with the effect of dried ginger in restoring yang and dredging meridians can promote blood circulation and improve microcirculation.

[0102] 6. Balance between bitter-cold and warming-middle-jiao: Coptis chinensis is bitter-cold, and dried ginger is pungent-warm. When used together, while reducing the stomach-injuring effect of the bitter-cold property of Coptis chinensis, it enhances the hypoglycemic effect. This compatibility embodies the principle of the opposite and complementary properties of drugs in traditional Chinese medicine prescriptions.

[0103] 7. Antioxidant and anti-inflammatory effects: Components such as Poria cocos, Rehmannia glutinosa, Coptis chinensis, Nelumbo nucifera Gaertn. leaf, and Trogopterus dung contain flavonoids or polysaccharides and other components, all of which have antioxidant effects, can scavenge free radicals, and reduce oxidative stress. At the same time, these components all have certain anti-inflammatory effects, which help reduce the inflammatory response caused by diabetes.

[0104] 8. Intestinal flora regulation effect: Dried ginger can improve the intestinal flora, and a good intestinal flora is crucial for blood glucose control. Other components such as Poria cocos and Atractylodes macrocephala Koidz. may also have a positive impact on the intestinal flora, jointly promoting intestinal health.

[0105] 9. Protective effect on pancreatic islet β cells: Polysaccharides and saponins contained in components such as ginseng, Achyranthes bidentata Blume, and Momordica grosvenori may protect pancreatic islet β cells and maintain the normal insulin secretion function through mechanisms such as antioxidant and anti-inflammatory effects.

[0106] 10. Comprehensive regulation and symptomatic treatment: Through the comprehensive action of components such as ginseng, Poria cocos, Atractylodes macrocephala Koidz., Angelica sinensis, and Lycium barbarum, it not only regulates blood glucose but also improves systemic symptoms, such as enhancing the body's immunity and improving cardiovascular health.

[0107] In summary, through the complex and delicate interactions of the components of this traditional Chinese medicine composition, a multi-level and multi-pathway comprehensive regulation system is formed. This comprehensive therapeutic effect not only regulates the body's blood glucose level but also improves the functional states of various systems of the whole body, providing comprehensive therapeutic support for diabetic patients.

[0108] Example 2 (1) Raw material preparation Accurately weigh the raw medicinal materials according to the weight ratio of the sugar-eliminating formula described in Example 1.

[0109] (2) Extraction and concentration Soaking: Put all the weighed raw medicinal materials into a suitable container, add 10 times the amount of water based on the total amount of the medicinal materials, ensure that all the medicinal materials are completely immersed in the water, and soak for about 30 minutes to allow the medicinal materials to fully absorb water and expand.

[0110] Decoction: Put the soaked medicinal materials together with the soaking liquid into a decocting pot. After boiling over high heat (strong fire), switch to low heat (gentle fire) for decoction. The decoction time for each time is 1 hour, and it is decocted three times in total. After each decoction, filter the liquid medicine with gauze or a filter net, retain the filtrate, and discard the medicinal residues.

[0111] Combine the filtrates: Combine the filtrates obtained from the three decoctions, and place them in a decocting pot to continue heating and concentrating over low heat. During the concentration process, it is necessary to continuously stir to prevent the liquid medicine from sticking to the bottom of the pot. Concentrate to an appropriate volume, and the specific volume can be adjusted according to the requirements of subsequent preparations.

[0112] (3)Preparation of preparations Preparation of oral liquid: Continue to heat the concentrated liquid medicine to an appropriate temperature, add an appropriate amount of flavoring agent (such as honey, sucrose, etc., optional), and stir evenly.

[0113] Dispense the liquid medicine into clean oral liquid bottles, seal them, and perform sterilization treatment (such as high-temperature steam sterilization) to obtain the Xiaotang Prescription oral liquid.

[0114] Preparation of granules: Add an appropriate amount of starch or other suitable excipients to the concentrated liquid medicine, stir well, and make the liquid medicine form a soft material.

[0115] Sieve the soft material to make granules, dry to an appropriate moisture content, size the granules, and package them to obtain the Xiaotang Prescription granules.

[0116] Preparation of tablets: Mix the concentrated liquid medicine with appropriate excipients such as starch and dextrin to make a soft material, and sieve it to make granules.

[0117] After drying the wet granules, add an appropriate lubricant (such as magnesium stearate), mix evenly, and press tablets to obtain the Xiaotang Prescription tablets.

[0118] (4)Quality inspection Conduct quality inspection on the prepared Xiaotang Prescription preparations, including items such as appearance, properties, content determination, and microbial limit inspection, to ensure that the preparation quality meets relevant standards.

[0119] (5)Packaging and storage Package the qualified Xiaotang Prescription preparations, indicate information such as the name of the drug, specifications, usage and dosage, expiration date, storage conditions, etc., and store them according to the specified storage conditions to ensure the stability of the drug quality.

[0120] Through the above steps, the Xiaotang Prescription preparations that meet the requirements can be prepared. In actual operation, the requirements of Good Manufacturing Practice for Drugs (GMP) should be strictly observed to ensure the safety and effectiveness of the drugs.

[0121] To further verify the hypoglycemic effect of the present invention, a diabetes model was established by intraperitoneally injecting streptozotocin (STZ) and nicotinamide (NA) solution into 6-week-old C57BL / 6J wild-type (WT) mice. Sixteen hours before drug administration, the mice were fasted but allowed water, weighed, and intraperitoneally injected with NA dissolved in normal saline at a dose of 240 mg / kg based on body weight. Fifteen minutes later, STZ solution was injected. Specifically, STZ solution was intraperitoneally injected at a dose of 100 mg / kg on day 0 (15 minutes after injecting NA) and day 2 to establish a stable diabetes model. Then, mice with a random blood glucose measurement value ≥ 16.7 mmol / L were selected as diabetes models and randomly divided into 3 groups, namely the model group, the positive control group, and the Xiaotangfang group (6 mice in each group).

[0122] Normal control group (Con): Six-week-old WT mice with a random blood glucose < 7.0 mmol / L after intraperitoneally injecting sodium citrate buffer equal in volume to the nicotinamide solution and the streptozotocin injection amount were used as the normal control group (6 mice).

[0123] Positive control group (Met): Diabetic mice were given metformin hydrochloride by gavage at a dose of 150 mg / kg.

[0124] Xiaotangfang group (FTF): The traditional Chinese medicine composition of Example 1 was used for gavage. After conversion based on the surface area of humans and mice, the dosage range of the drug for mice was 1.6487 g to 6.3512 g. In this example, it was set at 4 g / kg.d.

[0125] Model group (DM): Diabetic mice were given an equal volume of sterile pure water by gavage.

[0126] The positive control group, the Xiaotangfang group, and the model group were given gavage once a day at a fixed time for 8 consecutive weeks. The blood glucose of the mice was measured every 4 weeks, and the general condition of the mice was observed simultaneously.

[0127] All blood glucose detection data were entered into an Excel spreadsheet, and then statistical analysis was performed using Graphpad prism 10.0 software. The blood glucose levels of each group of mice are shown in Table 1: Table 1 Blood glucose of each group of mice at different intervention time points (mmol / L) ( ±SD)

[0128] Note: Comparison between the model group and the control group: *P < 0.05, **P < 0.01; Comparison between the Xiaotangfang group, the metformin group and the model group: # P < 0.05, ## P < 0.01; Comparison between the Xiaotangfang group and the metformin group (positive control group) & P < 0.05, &&P < 0.01.

[0129] As can be seen from Table 1, compared with the control group, the blood glucose levels of mice in the diabetes model group and the Xiaotangfang intervention group were significantly increased, with statistical significance (P < 0.01); compared with the diabetes model group, the blood glucose level of mice in the Xiaotangfang intervention group was significantly decreased, with statistical significance (P < 0.01).

[0130] The mice in the normal control group showed good physical conditions during the experiment, with stable weight gain, shiny hair, and flexible movement. While the hair of the mice in the model group became dry and rough during the experiment, and their movement was slightly slower. The hair condition and movement ability of the mice in the Xiaotangfang group intervened with Xiaotangfang were improved compared with those of the model group mice. Thus, it can be seen that the present invention has an obvious hypoglycemic effect on diabetic animals and can improve general conditions such as hair.

[0131] In order to reflect the roles of each component in the formula, a single-factor variable animal experiment was conducted. The experimental conditions were the same as the above-mentioned experiment. The changing factors of the comparative experiment are shown in Table 2, and the detection results are shown in Table 3: Table 2

[0132] Table 3

[0133] Note: Comparison of blood glucose values at 4w, 8w and 0w in the same group: *P < 0.05, **P < 0.01; Comparison of each group with the Xiaotangfang group at the same time point: # P < 0.05, ## P < 0.01.

[0134] As can be seen from Table 3, each formula in the present invention plays a synergistic role, and none of them can be missing, achieving a mutually promoting effect.

[0135] The treatment effect data of this traditional Chinese medicine composition on the human body are as follows: 1. General information: All the subjects included in this study were type 2 diabetes patients, a total of 100 cases, including 55 males and 45 females, with an age range between 35 and 70 years old, and the average age was 55 years old. All subjects were clinically diagnosed with type 2 diabetes and had not received insulin treatment.

[0136] Case inclusion criteria: Meeting the WHO diagnostic criteria for type 2 diabetes; Aged between 18 and 75 years old; Not receiving insulin treatment or having stopped insulin treatment for at least 3 months; Voluntarily participating in this study and signing an informed consent form.

[0137] Case exclusion criteria: Patients with type 1 diabetes; Patients with severe hepatic and renal insufficiency; Pregnant or lactating women; Those who are allergic to any ingredient in this traditional Chinese medicine composition; Those who have participated in other drug clinical trials recently; Those who are unable to cooperate to complete the study or cannot comply with the study regulations.

[0138] 4. Treatment method: All subjects received basic lifestyle interventions, including diet control, moderate exercise, etc.

[0139] The treatment group was given this traditional Chinese medicine composition, with a dose of one dose per day, taken twice (once in the morning and once in the evening), and taken continuously for 12 weeks.

[0140] The control group was given a placebo, with the same dose and administration method as the treatment group.

[0141] 5. Observation indicators: Main observation indicator: Fasting plasma glucose (FPG).

[0142] Secondary observation indicators: Traditional Chinese medicine syndrome scores. The scoring criteria for traditional Chinese medicine syndromes of diabetes are as follows: (1) Scope of application It is applicable to the quantitative evaluation of traditional Chinese medicine syndromes of type 2 diabetes (such as qi and yin deficiency, yin deficiency and internal heat, yin and yang deficiency, etc.), and to compare the improvement degree of syndromes before and after treatment.

[0143] (2) Scoring principles 1. Symptom grading: Each symptom is graded according to the severity as: asymptomatic (0 points), mild (2 points), moderate (4 points), severe (6 points).

[0144] 2. Symptom classification: It is divided into main symptoms (reflecting the core syndrome) and secondary symptoms (auxiliary syndrome differentiation), and the weight of main symptoms is higher than that of secondary symptoms.

[0145] 3. Tongue and pulse scoring: The tongue image and pulse condition are listed separately as important bases for syndrome diagnosis (not included in the total symptom score, but need to be recorded).

[0146] (3) Specific symptom scoring form: Table 4

[0147] (4) Total score calculation and syndrome grading 1. Total symptom score = total score of main symptoms + total score of secondary symptoms (the tongue and pulse can be recorded separately and not included in the total score).

[0148] 2. Severity of syndromes: 1. Mild: Total score ≤ 12 points (syndrome manifestations are not obvious); 2. Moderate: Total score 13 - 24 points (syndrome manifestations are typical); 3. Severe: Total score ≥ 25 points (syndrome manifestations are severe, affecting quality of life).

[0149] 6. Criteria for judging the efficacy of the main observation index (FPG) Marked effect: FPG decreased by more than 30% compared with that before treatment.

[0150] Effective: FPG decreased by 10% - 30% compared with that before treatment.

[0151] Ineffective: FPG had no obvious change or increased.

[0152] 7. Statistical methods SPSS statistical software was used for data analysis. Measurement data were expressed as mean ± standard deviation (xˉ ± s), and t - test or analysis of variance was used for comparison between groups; count data were expressed as frequency or percentage, and chi - square test was used for comparison between groups. P < 0.05 was considered statistically significant.

[0153] 8. Typical cases Patient Wang, female, 60 years old, newly diagnosed with type 2 diabetes, FPG 8.2 mmol / L. After 12 - week treatment with this traditional Chinese medicine composition through basic lifestyle interventions, including diet control and appropriate exercise, FPG decreased to 5.9 mmol / L, and no adverse reactions occurred.

[0154] 9. Results: Table 5 Effective rate (judged by FPG)

[0155] Table 6 Comparison of TCM syndrome scores of diabetic patients before and after treatment

[0156] Table 7 Comparison of blood glucose levels of two groups of diabetic patients before and after treatment

[0157] The above - described embodiments only represent the specific implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the protection scope of the present application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the technical solution of the present application, several deformations and improvements can still be made, and these all belong to the protection scope of the present application.

Claims

1. A Chinese medicine composition for treating diabetes, characterized in that: In parts by weight, it includes the following components: Ginseng: 3-15 portions; Poria: 10-30 portions; Atractylodes macrocephala: 5-30 parts; Achyranthes bidentata: 10-30 portions; Alisma orientalis: 10-30 portions; Raw Rehmannia root: 10-30 parts; Coptis chinensis: 5-30 portions; Cinnamon: 3-20 portions; Dried ginger: 5-20 portions; Monk fruit: 3-20 servings; Corn silk: 10-30 portions; Lotus leaf: 3-20 portions; Astragalus: 10-30 portions; Wolfberry: 10-20 servings; Scrophularia: 5-15 portions; Angelica: 5-15 portions; Snow lotus: 5-10 portions; Ophiopogon japonicus: 5-10 parts; Pyrrosia: 5-10 portions.

2. A Chinese medicine composition for treating diabetes according to claim 1, characterized in that: In parts by weight, it includes the following components: Ginseng: 15 parts; Poria: 20 parts; Atractylodes macrocephala: 20 parts; Achyranthes bidentata: 10 portions; Alisma: 10 parts; Raw Rehmannia root: 10 parts; Coptis chinensis: 15 parts; Cinnamon: 10 parts; Dried ginger: 10 portions; Monk fruit: 5 servings; Corn silk: 10 portions; Lotus leaf: 5 portions; Astragalus: 15 parts; Wolfberry: 15 servings; Scrophularia: 10 parts; Angelica: 10 parts; Snow lotus: 5 portions; Ophiopogon japonicus: 5 parts; Pyrola: 5 parts.

3. A Chinese medicine composition for treating diabetes according to claim 1 or 2, characterized in that: In grams by weight, it includes the following components: Ginseng: 15g; Poria: 20g; Atractylodes macrocephala: 20g; Achyranthes bidentata: 10g; Alisma orientalis: 10g; Raw Rehmannia root: 10g; Coptis chinensis: 15g; Cinnamon: 10g; Dried ginger: 10g; Monk fruit: 5g; Corn silk: 10g; Lotus leaf: 5g; Astragalus: 15g; Wolfberry: 15g; Scrophularia: 10g; Angelica: 10g; Snow lotus: 5g; Ophiopogon japonicus: 5g; Pyrola: 5g.

4. A method for preparing a Chinese medicine composition for treating diabetes, characterized in that: The following steps are involved: Step 1: Prepare raw materials according to the Chinese medicinal raw materials and proportions described in any one of claims 1 to 3; Step 2: Soak the prepared raw materials; Step 3: Decoction the raw materials and soaking liquid together several times; Step 4: combining and concentrating the medicinal solutions obtained by decoction for several times to obtain a concentrated medicinal solution; Step 5: Prepare the obtained concentrated drug solution into a preparation.

5. The method for preparing a Chinese medicine composition for treating diabetes according to claim 4, characterized in that: The weight of the soaking liquid added during soaking in step 2 is 10 times the total weight of the raw materials, and the soaking time is 30 minutes.

6. The method for preparing a Chinese medicine composition for treating diabetes according to claim 4, characterized in that: In step 3, the raw materials and the soaking liquid are first boiled with high heat, and then the high heat is changed to low heat to continue decocting, and the decoction time for each time is 1 hour; after the decoction is completed, the medicinal liquid and the medicinal residue are separated, and water is added to the medicinal residue for the next decoction.

7. A method for preparing a Chinese medicine composition for treating diabetes according to any one of claims 4 to 6, characterized in that: The preparation in step 5 is oral liquid, granules or tablets.

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