A traditional Chinese medicine composition for treating diabetes and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for treating diabetes and a preparation method thereof, belonging to the technical field of traditional Chinese medicine compositions. The present invention solves the problem of limited curative effect existing in the treatment of existing diabetes. The present invention is composed of the following components: ginseng: 3-15 parts; poria cocos: 10-30 parts; atractylodes macrocephala: 5-30 parts; achyranthes bidentata: 10-30 parts; alisma orientale: 10-30 parts; rehmannia glutinosa: 10-30 parts; coptis chinensis: 5-30 parts; cinnamon: 3-20 parts; dried ginger: 5-20 parts; momordica grosvenori: 3-20 parts; corn stigma: 10-30 parts; lotus leaf: 3-20 parts; astragalus membranaceus: 10-30 parts; wolfberry: 10-20 parts; scrophularia ningpoensis: 5-15 parts; angelica sinensis: 5-15 parts; snow lotus flower: 5-10 parts; trogopterus dung: 5-10 parts; pyrrosia lingua: 5-10 parts. The present invention can be used for treating type 2 diabetes, has the functions of regulating blood sugar and enhancing body metabolism, and has remarkable 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 worldwide, seriously 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 β-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, α-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:

[0008] A traditional Chinese medicine composition for treating diabetes, which is composed of the following components:

[0009] Ginseng: 3 - 15 parts;

[0010] 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, which can enhance the effect of insulin and play an insulin-like role, thereby reducing blood sugar. Experiments have confirmed that ginsenoside Re can significantly reduce the blood sugar level of experimental animals and improve the glucose tolerance ability at the same time. 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 glycated 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, thereby 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.

[0011] Poria cocos: 10 - 30 parts;

[0012] The polysaccharide components in Poria cocos can regulate blood sugar and help 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, thereby 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, which has a protective effect on the cardiovascular system. Poria cocos polysaccharides can effectively reduce the levels of blood sugar, serum insulin, glucagon, total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) in diabetic model mice, while increasing the level of high-density lipoprotein cholesterol (HDL-C).

[0013] Atractylodes macrocephala: 5 - 30 parts;

[0014] Atractylodes macrocephala can promote insulin secretion by pancreatic islet β cells and simultaneously inhibit hepatic glucose output, thus helping to lower blood glucose levels. Atractylodes macrocephala contains various active ingredients, such as volatile oils, polysaccharides, etc. These ingredients may participate in the regulation of the physiological and pathological processes of the body through different action pathways. In particular, the polysaccharide component of Atractylodes macrocephala has been proven to have a significant hypoglycemic effect, and its mechanism is related to improving insulin sensitivity, promoting insulin secretion, and regulating the activities of enzymes related to glucose metabolism.

[0015] Achyranthes bidentata: 10 - 30 parts;

[0016] The polysaccharide component in Achyranthes bidentata has a significant hypoglycemic effect. Achyranthes bidentata polysaccharide can lower the blood glucose level of experimental animals, and its mechanism may be related to promoting insulin secretion, improving insulin sensitivity, and regulating the activities 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 helping to control 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.

[0017] Alisma orientale: 10 - 30 parts;

[0018] 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 have obvious curative effects on diabetes and its complications. These components can regulate glucose metabolism disorders and achieve hypoglycemic effects. In addition to the 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.

[0019] Rehmannia glutinosa: 10 - 30 parts;

[0020] Rehmannia glutinosa has been proven to have hypoglycemic effects and is suitable for diabetic patients. Its hypoglycemic mechanism mainly includes promoting insulin secretion, enhancing insulin sensitivity, improving insulin resistance, and controlling blood sugar. Certain components in Rehmannia glutinosa, such as flavonoids and polysaccharides, have antioxidant activity, which can scavenge free radicals in the body, reduce oxidative stress reactions, thereby protecting pancreatic islet cells from damage and maintaining normal insulin secretion function. Rehmannia glutinosa can reduce the activity of liver glucose-6-phosphatase, which helps regulate the conversion of sugar into ATP to provide energy for the human body and also helps control blood sugar levels. Multiple active components in Rehmannia glutinosa have anti-inflammatory effects, which can inhibit inflammatory reactions and reduce the occurrence of tissue damage and complications caused by diabetes. In addition, it can also improve lipid metabolism disorders and kidney 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 components, which regulate blood sugar through multiple mechanisms and show significant antioxidant and anti-inflammatory effects.

[0021] Coptis chinensis: 5 - 30 parts;

[0022] Coptis chinensis shows significant hypoglycemic effects. For example, the water extract of Coptis chinensis can significantly reduce the blood sugar level in diabetic animal models. This effect may be related to active components such as berberine contained in Coptis chinensis. Coptis chinensis may regulate blood sugar 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 oxidative stress and inflammatory reactions 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 may have a positive impact on mechanisms such as insulin secretion and hepatic glycogen synthesis.

[0023] Cinnamomum cassia: 3 - 20 parts;

[0024] Active components in Cinnamomum cassia, such as cinnamic acid and cinnamaldehyde, can increase insulin sensitivity, promote glucose uptake and utilization, thereby reducing blood sugar levels. Cinnamomum cassia 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 the active components of Cinnamomum cassia, 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 sugar levels and reduce the risk of complications caused by diabetes.

[0025] Dried ginger: 5 - 20 parts;

[0026] Dried ginger contains various active ingredients such as gingerol and curcumin. These ingredients have been found in research to have a therapeutic effect 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 dried 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 lower blood sugar levels. Dried 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, dried ginger helps to protect pancreatic islet cells from further damage.

[0027] Momordica grosvenori: 3 - 20 parts;

[0028] Momordica grosvenori has shown significant efficacy in modern medical and pharmacological research on diabetes and its complications. It has been found that the mogrosides component 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 post - meal blood glucose levels. In addition, Momordica grosvenori also exerts its hypoglycemic effect 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 diabetic complications. Its active ingredients such as flavonoids and polysaccharides have effects of reducing blood lipids, antioxidant, and anti - inflammatory, which help to alleviate cardiovascular, kidney, and nerve complications caused by diabetes. At the same time, Momordica grosvenori can protect pancreatic β - cells from damage and promote insulin secretion, further improving the condition of diabetes.

[0029] Corn silk: 10 - 30 parts;

[0030] 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 lipid-lowering effect. Its flavonoid and polysaccharide components can regulate lipid metabolism, reduce the levels of total cholesterol, triglycerides, and low-density lipoprotein cholesterol, while increasing the level of high-density lipoprotein cholesterol, which helps prevent the occurrence of atherosclerosis. Corn silk is rich in antioxidant substances, 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 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 anti-fibrotic effect can also inhibit the occurrence and development of renal fibrosis and further protect renal function. Some 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 diabetic peripheral neuropathy and retinopathy.

[0031] Lotus leaf: 3 - 20 parts;

[0032] Active ingredients such as alkaloids and flavonoids in lotus leaf can inhibit the activity of α-glucosidase, delay carbohydrate hydrolysis and glucose absorption, and thus effectively control postprandial blood glucose levels. At the same time, these components can also promote insulin sensitivity and improve the insulin resistance state, further reducing blood glucose. In addition, lotus leaf also has the effect of regulating blood lipids, can inhibit fat synthesis and accumulation, promote fat decomposition, helps 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 preventing cardiovascular diseases. The antioxidant and anti-inflammatory effects of lotus leaf cannot be ignored: scavenging free radicals, reducing the damage of oxidative stress to tissues, and inhibiting inflammatory reactions, thus protecting islet β cells and other tissues from damage. These mechanisms of action together provide a scientific basis for the application of lotus leaf in the treatment of diabetes, especially showing potential therapeutic value in preventing or delaying diabetic cardiovascular complications, kidney complications, and retinal complications.

[0033] Astragalus membranaceus: 10 - 30 parts;

[0034] Astragalus membranaceus has shown significant pharmacological activities in the treatment of diabetes and its complications in recent years. Astragalus polysaccharide is one of the main active components of Astragalus membranaceus, with various effects such as hypoglycemic, improving insulin resistance, antioxidant and anti-inflammatory effects. Hypoglycemic effect: Astragalus polysaccharide can significantly reduce the blood glucose level of experimental diabetic animals, and its mechanism may be related to promoting insulin secretion and improving insulin resistance. Studies have shown that Astragalus polysaccharide can increase the synthesis of liver glycogen and reduce the breakdown of liver glycogen, thus lowering blood glucose. Improving insulin resistance: Astragalus polysaccharide can improve insulin sensitivity and the state of insulin resistance. It can regulate the insulin signal transduction pathway, increase the expression of GLUT4 transporter, and promote glucose uptake and utilization. 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, thus protecting the function of pancreatic islet β cells and delaying the development of diabetes and its complications.

[0035] Lycium barbarum: 10 - 20 parts;

[0036] Lycium barbarum is rich in various bioactive components such as Lycium barbarum polysaccharide, betaine, carotenoids, etc., and these components show potential pharmacological effects in the treatment of diabetes. Hypoglycemic effect: Lycium barbarum polysaccharide is the main hypoglycemic component of Lycium barbarum, which can significantly reduce the blood glucose level of experimental diabetic animals. Its mechanism may be related to promoting insulin secretion, improving insulin resistance, increasing liver glycogen synthesis, 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, lower blood lipid levels, and prevent the occurrence of diabetic cardiovascular complications.

[0037] Scrophularia ningpoensis: 5 - 15 parts;

[0038] The iridoid glycoside components in Scrophularia ningpoensis have various pharmacological effects such as hypoglycemic, anti-inflammatory and antioxidant effects. Hypoglycemic effect: The extract of Scrophularia ningpoensis 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 glycoside components in Scrophularia ningpoensis have significant anti-inflammatory activity, can inhibit inflammatory reactions, and reduce tissue damage caused by diabetes. Antioxidant effect: The extract of Scrophularia ningpoensis can also scavenge free radicals, reduce the damage of oxidative stress to cells, and protect the function of pancreatic islet β cells.

[0039] Angelica sinensis: 5 - 15 parts.

[0040] Angelica polysaccharide is one of the main active components of Angelica sinensis, with 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.

[0041] Saussurea involucrata: 5 - 10 parts;

[0042] Modern scientific research has proved that Saussurea involucrata contains various beneficial components for human body functions, such as flavonoids, alkaloids, etc. These components may play an important role in diabetes management. Certain components in Saussurea involucrata, such as flavonoids, can reduce the blood glucose level and have a certain adjuvant therapeutic effect on diabetic patients. Saussurea involucrata is rich in 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 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.

[0043] Trogopterus dung: 5 - 10 parts;

[0044] Although there is relatively little direct research on Trogopterus dung in diabetes, its effects of promoting blood circulation to remove blood stasis and stopping bleeding may have potential value in the treatment of diabetic complications. Trogopterus dung has the effects of promoting fibrinolysis 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 dung may help to reduce the inflammatory reaction in diabetic patients, thus protecting pancreatic islet β cells and other tissues and organs from inflammatory damage.

[0045] Pyrrosia lingua: 5 - 10 parts.

[0046] Modern research shows that Pyrrosia lingua contains flavonoids, polysaccharides and other active components, and these components show 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.

[0047] Preferably, by weight parts, it is composed of the following components:

[0048] Ginseng: 15 parts;

[0049] Poria: 20 parts;

[0050] Atractylodes macrocephala: 20 parts;

[0051] Achyranthes bidentata: 10 parts;

[0052] Alisma orientale: 10 parts;

[0053] Rehmannia glutinosa: 10 parts;

[0054] Coptis chinensis: 15 parts;

[0055] Cinnamomum cassia: 10 parts;

[0056] Zingiber officinale: 10 parts;

[0057] Momordica grosvenori: 5 parts;

[0058] Corn silk: 10 parts;

[0059] Lotus leaf: 5 parts;

[0060] Astragalus membranaceus: 15 parts;

[0061] Lycium barbarum: 15 parts;

[0062] Scrophularia ningpoensis: 10 parts;

[0063] Angelica sinensis: 10 parts;

[0064] Saussurea involucrata: 5 parts;

[0065] Trogopterus dung: 5 parts;

[0066] Pyrrosia lingua: 5 parts.

[0067] Preferably, in terms of weight in grams, it consists of the following components:

[0068] Ginseng: 15 g;

[0069] Poria: 20 g;

[0070] Atractylodes macrocephala: 20 g;

[0071] Achyranthes bidentata: 10 g;

[0072] Alisma orientale: 10 g;

[0073] Rehmannia glutinosa: 10 g;

[0074] Coptis chinensis: 15 g;

[0075] Cinnamomum cassia: 10 g;

[0076] Zingiber officinale: 10 g;

[0077] Momordica grosvenori: 5 g;

[0078] Corn silk: 10 g;

[0079] Lotus leaf: 5 g;

[0080] Astragalus membranaceus: 15 g;

[0081] Wolfberry fruit: 15 g;

[0082] Scrophularia ningpoensis: 10 g;

[0083] Angelica sinensis: 10 g;

[0084] Snow lotus flower: 5 g;

[0085] Trogopterus dung: 5 g;

[0086] Pyrrosia lingua: 5 g.

[0087] A preparation method of a traditional Chinese medicine composition for treating diabetes, comprising the following steps:

[0088] Step 1: Prepare raw materials according to the required traditional Chinese medicine raw materials and their ratios;

[0089] Step 2: Soak the prepared raw materials;

[0090] Step 3: Decoct the raw materials and the soaking solution together several times;

[0091] Step 4: Combine and concentrate the medicinal liquids obtained from several times of decocting to obtain a concentrated medicinal liquid;

[0092] Step 5: Prepare the obtained concentrated medicinal liquid into a preparation

[0093] Preferably, in Step 2, the weight of the soaking solution added during soaking is 10 times the total weight of the raw materials, and the soaking time is 30 minutes.

[0094] 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.

[0095] Preferably, the preparation in Step 5 is oral liquid, granule or tablet.

[0096] In summary, due to the adoption of the above technical solutions, the beneficial effects of the present invention are:

[0097] 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 sugar and enhancing the body's metabolic function, providing a new option for the clinical treatment of diabetes. This traditional Chinese medicine composition can achieve the purpose of reducing blood sugar and delaying the occurrence of diabetic complications by the synergistic action of multiple components, improving insulin resistance, and promoting the recovery of pancreatic islet β-cell function.

[0098] 2. The traditional Chinese medicine composition provided by the present invention realizes the comprehensive effects of multiple components, multiple targets, and multiple pathways through the scientific compatibility of multiple traditional Chinese medicine components, has a significant blood sugar lowering effect, can better regulate the body function, improve insulin resistance, and promote the recovery of pancreatic islet β-cell function.

[0099] 3. The traditional Chinese medicine composition provided by the present invention not only has a good blood sugar lowering effect, but also can improve the general symptoms of diabetic patients, which is beneficial to the overall recovery of patients.

[0100] 4. The traditional Chinese medicine composition provided by the present invention has significant curative effects and a very broad application prospect, and is expected to bring good news to more diabetic patients. Detailed implementation mode

[0101] 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 the embodiments. Embodiment

[0102] A traditional Chinese medicine composition for treating diabetes is composed of the following components:

[0103] Ginseng: 15 g;

[0104] Poria cocos: 20 g;

[0105] Atractylodes macrocephala: 20 g;

[0106] Achyranthes bidentata: 10 g;

[0107] Alisma orientale: 10 g;

[0108] Rehmannia glutinosa: 10 g;

[0109] Coptis chinensis: 15 g;

[0110] Cinnamomum cassia: 10 g;

[0111] Zingiber officinale: 10 g;

[0112] Momordica grosvenori: 5 g;

[0113] Corn silk: 10 g;

[0114] Lotus leaf: 5 g;

[0115] Astragalus membranaceus: 15 g;

[0116] Lycium barbarum: 15 g;

[0117] Scrophularia ningpoensis: 10 g;

[0118] Angelica sinensis: 10 g;

[0119] Saussurea involucrata: 5 g;

[0120] Trogopterus dungarctus: 5 g;

[0121] Pyrrosia lingua: 5 g.

[0122] The mechanism of action of the interaction between each component is analyzed from the aspect of the components as follows:

[0123] 1. Ginseng

[0124] Core function: As the sovereign drug, ginseng plays a leading role in the whole formula. Its main components, ginsenosides and ginseng polysaccharides, have significant effects in lowering blood sugar and improving insulin sensitivity.

[0125] With Poria cocos and Atractylodes macrocephala: By enhancing the function of the spleen and stomach and promoting digestion and absorption, ginseng 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.

[0126] With Coptis chinensis and Rehmannia glutinosa: The effect of ginseng in promoting fluid production and nourishing blood is closely related to the generation of body fluid, while Rehmannia glutinosa and Coptis chinensis regulate the internal heat 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.

[0127] 2. Poria cocos

[0128] Core function: The diuretic and dampness-promoting effect of Poria cocos is crucial for relieving the edema of diabetic patients. Its polysaccharides and flavonoids can also regulate blood sugar and enhance insulin signal transduction.

[0129] With ginseng and Atractylodes macrocephala: The synergistic effect of Poria cocos with these two is not limited to strengthening the spleen and promoting diuresis, but also can promote the excretion of dampness in the body and relieve the glucose metabolism disorder caused by the accumulation of dampness pathogen.

[0130] With Alisma orientale: Poria cocos and Alisma orientale have similar effects in promoting diuresis. The combined use of the two can significantly enhance the diuretic effect and accelerate the excretion of excess water in the body, thus relieving edema and microcirculation disorders.

[0131] 3. Atractylodes macrocephala

[0132] Core functions: Atractylodes macrocephala can not only invigorate the spleen and replenish qi, but also dry dampness and promote diuresis, showing significant efficacy in the common symptoms of spleen deficiency and dampness entrapment in diabetic patients. Its polysaccharide component regulates blood sugar by enhancing insulin sensitivity and promoting insulin secretion.

[0133] With Poria cocos and Ginseng: The three together construct a powerful spleen-invigorating system, enhancing the transportation and transformation functions of the spleen and stomach, providing sufficient nutritional support for the body, and helping to improve glucose metabolism.

[0134] With Achyranthes bidentata: The combination of the dampness-drying effect of Atractylodes macrocephala and the diuretic and stranguria-relieving effect of Achyranthes bidentata helps to remove dampness in the body and improve the symptoms of limb heaviness and edema in diabetic patients.

[0135] 4. Achyranthes bidentata

[0136] Core functions: The functions of Achyranthes bidentata in tonifying the liver and kidney and strengthening the bones and muscles significantly improve the weakness and fatigue in diabetic patients caused by osteoporosis and muscle atrophy. Its polysaccharide component can also promote insulin secretion and enhance insulin sensitivity.

[0137] With Poria cocos and Alisma orientale: The three work together to accelerate the excretion of excess water in the body, helping to improve the microcirculation and edema symptoms in diabetic patients.

[0138] 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, regulating the balance of yin and yang in the body and having a positive impact on the general symptoms of diabetic patients.

[0139] 5. Alisma orientale

[0140] Core functions: Alisma orientale helps diabetic patients excrete excess water in the body through its diuretic and dampness-percolating effect, reducing edema. Its alcohol-soluble and water-soluble components have obvious efficacy in diabetes and its complications.

[0141] With Poria cocos and Achyranthes bidentata: The three together exert a powerful diuretic effect, improving the body fluid circulation and metabolic state of diabetic patients.

[0142] With Coptis chinensis: The combination of the turbidity-resolving and lipid-lowering effect of Alisma orientale and the heat-clearing and dampness-drying efficacy of Coptis chinensis helps to regulate blood lipids and prevent the occurrence of diabetic cardiovascular diseases.

[0143] 6. Rehmannia glutinosa

[0144] Core functions: Rehmannia glutinosa has the effects of clearing heat and cooling blood, nourishing yin and promoting fluid production, showing significant efficacy in the symptoms of yin deficiency and internal heat in diabetic patients. Its various active components such as flavonoids and polysaccharides have antioxidant and anti-inflammatory effects.

[0145] With Coptis chinensis: The two work together to clear heat, reducing the internal heat symptoms in diabetic patients and protecting pancreatic islet cells from damage.

[0146] With cinnamon: The combination of raw rehmannia nourishing yin and promoting body fluid and cinnamon warming yang and dispersing cold helps regulate the body's yin and yang balance and improve the systemic symptoms of diabetic patients.

[0147] 7. Coptis chinensis

[0148] Core effect: Coptis chinensis helps relieve the internal heat and toxicity symptoms of diabetic patients by clearing away heat and dampness, purging fire and detoxifying. Its active ingredients such as berberine can significantly reduce blood sugar levels.

[0149] Together with Rehmannia root, the two can clear away heat and jointly regulate heat in the body, alleviating symptoms such as thirst and polydipsia in diabetic patients.

[0150] With cinnamon and dried ginger: The heat-clearing effect of Coptis chinensis and the warming and cold-dispersing effects of cinnamon and dried ginger restrain each other, avoiding the disadvantages of excessive heat-clearing or excessive warming and nourishing, and maintaining the stability of the body's internal environment.

[0151] 8. Cinnamon

[0152] Core function: Cinnamon helps improve the symptoms of yang deficiency and internal cold in diabetic patients by replenishing fire and yang, dispelling cold and relieving pain. Its active ingredients such as cinnamic acid and cinnamogen can increase insulin sensitivity.

[0153] With dried ginger: The two work together to warm the middle and dispel cold, strengthen the spleen and stomach function, promote the circulation of qi and blood, and provide adequate nutritional support for all organs in the body.

[0154] With Coptis chinensis: The warming effect of cinnamon restrains the cold nature of Coptis chinensis, protecting the spleen and stomach from damage, while promoting the mild effect of Coptis chinensis.

[0155] 9. Dried ginger

[0156] Core effect: Dry ginger improves the symptoms of spleen and stomach deficiency and coldness in diabetic patients by warming the middle and dispelling cold, restoring yang and unblocking meridians. Its gingerol and other ingredients have a protective effect on pancreatic β cells.

[0157] With cinnamon: the two work synergistically to enhance the effect of warming the middle and dispersing cold, which helps to improve the whole body cold condition of diabetic patients.

[0158] With Coptis chinensis: The warm nature of dried ginger neutralizes the cold nature of Coptis chinensis, making the whole formula more mild and reducing the occurrence of side effects.

[0159] 10. Monk Fruit

[0160] Core function: Monk fruit can quench thirst and effectively relieve the thirst symptoms of patients with diabetes. This is of great significance to improving the quality of life of patients. The components in Monk fruit have been confirmed by modern pharmacological research to have the effect of lowering blood sugar.

[0161] With Coptis chinensis: The function of promoting fluid production and quenching thirst of Momordica grosvenori Swingle and the function of clearing heat and purging fire of Coptis chinensis complement each other, jointly improving the heat syndrome of patients with diabetes, such as dry mouth and bitter taste.

[0162] With Cinnamon: The yang-warming function of Cinnamon and the function of promoting fluid production and quenching thirst of Momordica grosvenori Swingle cooperate to help balance yin and yang in the body and improve the overall condition of patients.

[0163] 11. Corn Silk

[0164] Core functions: 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 diabetes due to water metabolism disorders. Corn silk has a hypoglycemic effect, which helps to control the blood sugar level of patients with diabetes and prevent the occurrence of complications.

[0165] With Poria cocos: When Corn silk and Poria cocos are used in combination, it can enhance the diuretic and detumescence effect and improve the edema symptoms of patients.

[0166] With Alisma orientale: When Corn silk and Alisma orientale are combined, it can further enhance the diuretic effect and promote the excretion of damp pathogens in the body, helping to improve the water metabolism disorders of patients with diabetes.

[0167] 12. Lotus Leaf

[0168] Core functions: Lotus leaf relieves the symptoms of restlessness and thirst of patients with diabetes due to yin deficiency and excessive fire, improves the abnormal blood lipid metabolism of patients with diabetes, and prevents the occurrence of complications such as diabetic cardiovascular diseases.

[0169] Compatibility with Rehmannia glutinosa: When Lotus leaf and Rehmannia glutinosa are used in combination, it can balance yin and yang in the body, nourish yin and moisten dryness, and improve the symptoms of yin deficiency and excessive fire of patients with diabetes.

[0170] 13. Astragalus membranaceus

[0171] Core functions: Astragalus membranaceus is an important herb for replenishing qi in the formula, mainly responsible for enhancing the body's immunity and improving qi deficiency symptoms such as fatigue and spontaneous sweating. In the treatment of diabetes, Astragalus membranaceus helps to lower the blood sugar level by replenishing qi and consolidating the exterior, improving the body's ability to utilize sugar.

[0172] Compatibility with Lycium barbarum: The qi-tonifying effect of Astragalus membranaceus combined with the effect of nourishing the liver and kidney of Lycium barbarum can enhance the overall function of the body and improve the disease resistance.

[0173] Compatibility with Scrophularia ningpoensis: The qi-tonifying and exterior-consolidating effect of Astragalus membranaceus and the heat-clearing and blood-cooling effect of Scrophularia ningpoensis complement each other, being able to both replenish qi and clear heat, and helping to regulate the yin-yang balance in the body.

[0174] Compatibility with Angelica sinensis: The qi-tonifying 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.

[0175] 14. Lycium barbarum

[0176] Core functions: Chinese wolfberry is mainly responsible for nourishing the liver and kidney, improving eyesight, and has a significant effect on improving the symptoms of consumptive thirst caused by yin deficiency of the liver and kidney. At the same time, the polysaccharide component in Chinese wolfberry has a hypoglycemic effect and can assist in controlling blood sugar levels.

[0177] Compatibility with Astragalus membranaceus: As mentioned above, the combination of Chinese wolfberry and Astragalus membranaceus can enhance the overall function of the body and improve disease resistance.

[0178] Compatibility with Scrophularia ningpoensis: The combination of the liver and kidney nourishing effect of Chinese wolfberry and 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 consumptive thirst.

[0179] Compatibility with Angelica sinensis: The combination of the liver and kidney nourishing effect of Chinese wolfberry and 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.

[0180] 15. Scrophularia ningpoensis

[0181] Core functions: Scrophularia ningpoensis is mainly responsible for clearing heat and cooling blood, nourishing yin and reducing fire, and has a significant effect on improving the symptoms of consumptive thirst caused by excessive fire due to yin deficiency. At the same time, Scrophularia ningpoensis also has the effect of detoxifying and dissipating nodules, and can eliminate heat toxins and stasis in the body.

[0182] 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.

[0183] Compatibility with Chinese wolfberry: As mentioned above, the combination of Scrophularia ningpoensis and Chinese wolfberry 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 consumptive thirst.

[0184] Compatibility with Angelica sinensis: The combination of the heat-clearing and blood-cooling effect of Scrophularia ningpoensis and the blood-tonifying and blood-activating effect of Angelica sinensis can improve the symptoms of consumptive thirst caused by heat toxin stasis.

[0185] 16. Angelica sinensis

[0186] Core functions: Angelica sinensis is mainly responsible for tonifying blood and promoting blood circulation, regulating menstruation and relieving pain, and has a significant effect on improving the symptoms of consumptive thirst caused by qi and blood deficiency. 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 dryness-heat in patients with consumptive thirst.

[0187] Compatibility with Astragalus membranaceus: As mentioned above, the combination of Angelica sinensis and Astragalus membranaceus can improve the state of qi and blood deficiency and promote the recovery of the body.

[0188] Compatibility with Chinese wolfberry: As mentioned above, the combination of Angelica sinensis and Chinese wolfberry can improve the state of qi and blood deficiency and enhance the disease resistance of the body.

[0189] Compatibility with Scrophulariae Radix: As mentioned above, the combination of the blood-tonifying and blood-activating effects of Angelicae Sinensis Radix and the heat-clearing and blood-cooling effects of Scrophulariae Radix can improve the symptoms of consumptive thirst caused by heat-toxin and blood stasis.

[0190] 17. Saussurea involucrata

[0191] Core effect: Saussurea involucrata is warm in nature and can warm and tonify the kidney yang, which has an improving effect on symptoms such as soreness and weakness of the waist and knees, and fear of cold and cold limbs caused by the decline of kidney yang in consumptive thirst patients. 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.

[0192] Compatibility with Ginseng Radix et Rhizoma and Astragali Radix: 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 consumptive thirst.

[0193] Compatibility with Rehmanniae Radix and Coptidis Rhizoma: Rehmanniae Radix nourishes yin and tonifies the kidney, Coptidis Rhizoma 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.

[0194] 18. Trogopterori Faeces

[0195] Core effect: Trogopterori Faeces can promote blood circulation and remove blood stasis, which has a significant improving effect on blood stasis syndrome caused by consumptive thirst (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 consumptive thirst, Trogopterori Faeces has a good analgesic effect and improves patient comfort.

[0196] Compatibility with Angelicae Sinensis Radix and Salviae Miltiorrhizae Radix: Angelicae Sinensis Radix and Salviae Miltiorrhizae Radix are both herbs for promoting blood circulation and removing blood stasis. When combined with Trogopterori Faeces, they can enhance the effect of promoting blood circulation and removing blood stasis, accelerate metabolism, and contribute to blood sugar stability.

[0197] Compatibility with Coptidis Rhizoma and Rehmanniae Radix: Coptidis Rhizoma clears heat and dries dampness, Rehmanniae Radix nourishes yin and tonifies the kidney. Combined with the blood-activating and stasis-removing effect of Trogopterori Faeces, they jointly regulate the balance of yin and yang in the body and improve the symptoms of consumptive thirst.

[0198] 19. Pyrrosiae Folium

[0199] Core effect: Pyrrosiae Folium has a significant diuretic effect, which can increase urine volume, help excrete excess sugar and toxins in the body, reduce the burden on the kidneys, and has an improving effect on symptoms such as polyuria and edema caused by consumptive thirst. The heat-clearing and detoxifying effect of Pyrrosiae Folium helps to clear heat toxins in the body and improve the heat symptoms of consumptive thirst patients, such as thirst and excessive drinking.

[0200] Compatibility with Stigma Maydis and Alismatis Rhizoma: Stigma Maydis and Alismatis Rhizoma are both herbs for promoting diuresis and percolating dampness. When combined with Pyrrosiae Folium, they can significantly enhance the diuretic effect and accelerate the excretion of excess water in the body, which is beneficial to blood sugar control.

[0201] 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 diuretic and stranguria-relieving effect of Pyrrosia lingua, it clears heat and tonifies at the same time, jointly regulating the balance of body fluid metabolism and sugar metabolism.

[0202] The mechanism of action of the mutual cooperation among the components is analyzed from the efficacy as follows:

[0203] 1. Hypoglycemic central effect of ginseng:

[0204] As the monarch drug, ginseng contains components such as ginsenoside Re and Rb1, which not only enhance insulin sensitivity but also simulate the effect 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.

[0205] 2. Spleen-strengthening and dampness-removing effect:

[0206] 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 excreting dampness, while Atractylodes macrocephala can dry dampness and promote diuresis while strengthening the spleen. Pyrrosia lingua also has the efficacy of promoting diuresis and relieving stranguria. When combined with Poria cocos and Atractylodes macrocephala, it can more comprehensively improve the symptoms caused by spleen deficiency and dampness obstruction, such as edema and fatigue.

[0207] 3. Diuretic and kidney-tonifying effect:

[0208] Achyranthes bidentata, Alisma orientale, Zea mays stigma and Nelumbo nucifera 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 to reduce the burden on the kidneys and protect kidney function. The diuretic efficacy of Pyrrosia lingua can also play an auxiliary role in this link and strengthen the effect of promoting diuresis and tonifying the kidney.

[0209] 4. Heat-clearing and yin-nourishing effect:

[0210] Raw Rehmannia glutinosa nourishes yin and promotes the production of body fluid, Coptis chinensis clears heat and dries dampness, Scrophularia ningpoensis nourishes yin and reduces fire, Momordica grosvenori clears heat and moistens the lungs, promotes the production of body fluid and quenches thirst, and Saussurea involucrata can clear heat and reduce swelling. When combined, on the one hand, it supplements the body fluid consumed by diabetic 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.

[0211] 5. Yang-warming and cold-dispelling effect:

[0212] The yang-warming effect of Cinnamomum cassia and Zingiber officinale helps to improve the symptoms such as cold limbs and fear of cold often seen in diabetic patients. The meridians-warming effect of Cinnamomum cassia combined with the yang-returning and meridians-unblocking effect of Zingiber officinale can promote blood circulation and improve microcirculation.

[0213] 6. Balance between bitter-cold and warm-middle:

[0214] Coptis chinensis is bitter and cold, and Zingiber officinale is pungent and warm. When the two are used together, while reducing the harm of the bitter-cold nature of Coptis chinensis to the stomach, the hypoglycemic effect is enhanced. This compatibility reflects the principle of the opposite and complementary nature of the properties and flavors of traditional Chinese medicine prescriptions.

[0215] 7. Antioxidant and Anti-Inflammatory Effects:

[0216] The flavonoids or polysaccharides contained in Poria, Rehmannia root, Coptis root, lotus leaf, and Atractylodes lancea all have antioxidant effects, which can remove free radicals and reduce oxidative stress. At the same time, these ingredients all have certain anti-inflammatory effects, which help to reduce the inflammatory response caused by diabetes.

[0217] 8. Intestinal flora regulation effect:

[0218] Dried ginger can improve intestinal flora, and a good intestinal flora is essential for blood sugar control. Other ingredients such as Poria cocos and Atractylodes macrocephala may also have a positive effect on intestinal flora and jointly promote intestinal health.

[0219] 9. Protective effect on pancreatic β cells:

[0220] The polysaccharides and saponins contained in ingredients such as ginseng, Achyranthes bidentata, and Momordica grosvenori may protect pancreatic beta cells and maintain normal insulin secretion function through antioxidant and anti-inflammatory mechanisms.

[0221] 10. Comprehensive adjustment and symptomatic treatment:

[0222] Through the combined effects of ingredients such as ginseng, Poria cocos, Atractylodes macrocephala, Chinese angelica and wolfberry, it not only regulates blood sugar but also improves systemic symptoms, such as enhancing the body's immunity and improving cardiovascular health.

[0223] In summary, the various components of the Chinese medicine composition form a multi-level, multi-pathway comprehensive regulation system through complex and delicate interactions. This comprehensive therapeutic effect not only regulates the body's blood sugar level, but also improves the functional state of various systems in the body, providing comprehensive therapeutic support for diabetic patients.

[0224] Example 2

[0225] (1) Raw material preparation

[0226] According to the weight ratio of the Xiaotang recipe described in Example 1, accurately weigh the raw materials.

[0227] (2) Extraction and concentration

[0228] Soaking: Place all the weighed APIs into a suitable container, add 10 times the amount of water as the total amount of the medicinal materials, and ensure that all the medicinal materials are completely immersed in the water. Soak for about 30 minutes to allow the medicinal materials to fully absorb water and swell.

[0229] 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. Each decoction takes 1 hour and is done three times in total. After each decoction, filter the liquid medicine with gauze or a filter net, keep the filtrate, and discard the residue.

[0230] Combine the filtrates: Combine the filtrates obtained from the three decoctions and place them in a decocting pot. Continue to heat and concentrate over low heat. Stir constantly during the concentration process 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.

[0231] (3)Preparation of preparations

[0232] Preparation of oral liquid:

[0233] 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.

[0234] Dispense the liquid medicine into clean oral liquid bottles, seal them, and perform sterilization treatment (such as high-temperature steam sterilization) to obtain the Xiaotangfang oral liquid.

[0235] Preparation of granules:

[0236] Add an appropriate amount of starch or other suitable excipients to the concentrated liquid medicine and stir well to form a soft material.

[0237] Sieve the soft material to make granules, dry to an appropriate moisture content, size the granules, and package them to obtain the Xiaotangfang granules.

[0238] Preparation of tablets:

[0239] Mix the concentrated liquid medicine with appropriate excipients such as starch and dextrin to make a soft material, and sieve to make granules.

[0240] After drying the wet granules, add a suitable lubricant (such as magnesium stearate), mix well, and press into tablets to obtain the Xiaotangfang tablets.

[0241] (4)Quality inspection

[0242] Conduct quality inspection on the prepared Xiaotangfang preparations, including items such as appearance, properties, content determination, and microbial limit inspection, to ensure that the preparation quality meets relevant standards.

[0243] (5)Packaging and storage

[0244] Package the qualified Xiaotangfang 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.

[0245] Through the above steps, the antidiabetic prescription preparation that meets the requirements can be prepared. In actual operation, the requirements of Good Manufacturing Practice (GMP) for drugs should be strictly adhered to to ensure the safety and effectiveness of the drugs.

[0246] To further verify the hypoglycemic effect of the present invention, a diabetic model was established by intraperitoneally injecting streptozotocin (STZ) and nicotinamide (NA) solution into 6-week-old wild-type (WT) C57BL / 6J mice. Sixteen hours before drug administration, the mice were fasted but allowed free access to water, weighed, and then intraperitoneally injected with NA dissolved in physiological 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 diabetic model. Then, mice with a random blood glucose measurement value ≥ 16.7 mmol / L were selected as diabetic models and randomly divided into 3 groups, namely the model group, the positive control group, and the FTF group (6 mice in each group).

[0247] Normal control group (Con): Six-week-old WT mice with a random blood glucose < 7.0 mmol / L after intraperitoneally injecting sodium citrate buffer solution in an amount equal to that of the nicotinamide solution and streptozotocin injection were used as the normal control group (6 mice).

[0248] Positive control group (Met): Diabetic mice were given metformin hydrochloride by gavage at a dose of 150 mg / kg.

[0249] FTF group: The traditional Chinese medicine composition of Example 1 was used for gavage. After conversion according to the body surface area of humans and mice, the dosage range of the drug for mice was 1.6487 g to 6.3512 g, and in this example, it was set at 4 g / kg.d.

[0250] Model group (DM): Diabetic mice were given an equal volume of sterile pure water by gavage.

[0251] The positive control group, the FTF 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.

[0252] All the 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:

[0253] ;

[0254] Note: Comparison between the model group and the control group: *P < 0.05, **P < 0.01; Comparison between the FTF 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.

[0255] As can be seen from Table 1, compared with the control group, the blood glucose levels of the mice in the diabetic model group and the Xiaotangfang intervention group were significantly increased, with statistical significance (P < 0.01); compared with the diabetic model group, the blood glucose level of the mice in the Xiaotangfang intervention group was significantly decreased, with statistical significance (P < 0.01).

[0256] The mice in the normal control group showed good physical conditions during the experiment, with stable weight gain, bright 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 slow. The hair condition and movement ability of the mice in the Xiaotangfang group intervened with Xiaotangfang were improved compared with those of the mice in the model group. 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.

[0257] 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 those of the above experiment. The changing factors of the comparative experiment are shown in Table 2, and the detection results are shown in Table 3:

[0258] ;

[0259] ;

[0260] 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.

[0261] 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.

[0262] The treatment effect data of this traditional Chinese medicine composition on humans are as follows:

[0263] 1. General information:

[0264] All the subjects included in this study were type 2 diabetes patients, totaling 100 cases, including 55 males and 45 females, with an age range of 35 to 70 years old and an average age of 55 years. All subjects were clinically diagnosed with type 2 diabetes and had not received insulin treatment.

[0265] 2. Case inclusion criteria:

[0266] Meeting the WHO diagnostic criteria for type 2 diabetes;

[0267] Aged between 18 and 75 years old;

[0268] Not treated with insulin or having stopped insulin treatment for at least 3 months;

[0269] Voluntarily participate in this study and sign the informed consent form.

[0270] 3. Case exclusion criteria:

[0271] Patients with type 1 diabetes;

[0272] Those with severe hepatic and renal insufficiency;

[0273] Pregnant or lactating women;

[0274] Those allergic to any ingredient in this traditional Chinese medicine composition;

[0275] Those who have participated in other drug clinical trials recently;

[0276] Those who are unable to cooperate to complete the study or cannot comply with the study regulations.

[0277] 4. Treatment methods:

[0278] All subjects will receive basic lifestyle interventions, including diet control, appropriate exercise, etc.

[0279] The treatment group will be 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.

[0280] The control group will be given a placebo, with the same dose and administration method as the treatment group.

[0281] 5. Observation indicators:

[0282] Main observation indicator: Fasting plasma glucose (FPG).

[0283] Secondary observation indicators: Traditional Chinese medicine syndrome scores. The traditional Chinese medicine syndrome scoring criteria for diabetes are as follows:

[0284] (1) Scope of application

[0285] 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.

[0286] (2) Scoring principles

[0287] 1. Symptom grading: Each symptom is graded according to the severity as: asymptomatic (0 points), mild (2 points), moderate (4 points), severe (6 points).

[0288] 2. Symptom Classification: It is divided into main symptoms (reflecting the core syndromes) and secondary symptoms (assisting in syndrome differentiation). The weight of main symptoms is higher than that of secondary symptoms.

[0289] 3. Tongue and Pulse Scoring: The tongue manifestation and pulse condition are listed separately as important bases for syndrome diagnosis (not included in the total symptom score but need to be recorded).

[0290] (3)Specific Symptom Scoring Table:

[0291] 。

[0292] (4)Total Score Calculation and Syndrome Grading

[0293] 1. Total symptom score = total score of main symptoms + total score of secondary symptoms (the tongue and pulse can be recorded separately and are not included in the total score).

[0294] 2. Syndrome severity:

[0295] 1. Mild: Total score ≤ 12 points (syndrome manifestations are not obvious);

[0296] 2. Moderate: Total score 13 - 24 points (syndrome manifestations are typical);

[0297] 3. Severe: Total score ≥ 25 points (syndrome manifestations are severe and affect the quality of life).

[0298] 6. Criteria for Judging the Efficacy of the Main Observation Index (FPG)

[0299] Marked effect: FPG decreased by more than 30% compared with that before treatment.

[0300] Effective: FPG decreased by 10% to 30% compared with that before treatment.

[0301] Ineffective: FPG had no obvious change or increased.

[0302] 7. Statistical Methods

[0303] 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.

[0304] 8. Typical Cases

[0305] Patient Wang, female, 60 years old, newly diagnosed with type 2 diabetes, FPG 8.2 mmol / L. After 12 weeks of treatment with this traditional Chinese medicine composition following basic lifestyle interventions, including diet control and appropriate exercise, the FPG decreased to 5.9 mmol / L, and no adverse reactions occurred.

[0306] 9. Results:

[0307] ;

[0308] ;

[0309] 。

[0310] The above-described embodiments merely 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 fall within the protection scope of the present application.

Claims

1. A Chinese medicine composition for treating diabetes, characterized in that: In parts by weight, it is composed of 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.

2. A Chinese medicine composition for treating diabetes according to claim 1, characterized in that: In grams by weight, it is composed of the following components: Ginseng: 15g; Poria: 20 g; Atractylodes macrocephala: 20 g; Achyranthes bidentata: 10 g; Alisma orientalis: 10 g; Raw Rehmannia root: 10 g; Coptis chinensis: 15 g; Cinnamon: 10 g; Dried ginger: 10 g; 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.

3. 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 1-2; 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.

4. The method for preparing a Chinese medicine composition for treating diabetes according to claim 3, 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.

5. The method for preparing a Chinese medicine composition for treating diabetes according to claim 3, 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.

6. A method for preparing a Chinese medicine composition for treating diabetes according to any one of claims 3 to 5, characterized in that: The preparation in step 5 is oral liquid, granules or tablets.