Drugs used to treat or assist in the treatment of diabetes

Abstract

The invention belongs to the field of medicine and provides a medicine for treating or assisting in treating diabetes. The medicine is prepared by containing the following components in parts by weight: 15-25 parts by weight of ginseng; 52-68 parts by weight of prepared rehmannia; 54-65 parts by weight of figwort; 25-35 parts by weight of cornus officinalis; 51-67 parts by weight of dodder seed; 36-45 parts by weight of atractylodes; 26-34 parts by weight of millettia reticulata; 50-70 parts by weight of agrimony; 21-27 parts by weight of rhubarb; 16-25 parts by weight of cinnamon bark; 35-45 parts by weight of coptis root; 11-21 parts by weight of leech; 53-68 parts by weight of astragalus; 52-68 parts by weight of mulberry bark; gypsum: 210-275 parts by weight; 25-36 parts by weight of anemarrhena; and 24-35 parts by weight of salvia miltiorrhiza. This drug can be used alone or in combination with insulin injection / oral hypoglycemic Western medicine, and has a significant therapeutic effect on diabetes.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a medicine for treating or assisting in treating diabetes. Background Art

[0002] Diabetes mellitus is a syndrome characterized by chronic hyperglycemia and its complications, which are characterized by significant heterogeneity and are caused by genetic, environmental, and immune factors. Diabetes mellitus falls under the category of "xiaoke" (experienced thirst) in Traditional Chinese Medicine (TCM). TCM believes that diabetes is caused by yin deficiency, weakness of the five internal organs, unregulated diet, excessive consumption of fatty and sweet foods, mental stimulation, emotional imbalance, invasion of toxic pathogens, long-term alcohol consumption, and excessive sexual intercourse, leading to a pathological process in which dryness, heat, and dampness accumulate, yin fluid is depleted, blood stasis occurs, and yang qi is weakened, ultimately causing an imbalance of yin and yang. The organs affected by diabetes primarily damage the lungs, spleen, and kidneys, with damage also common to the heart, liver, and gastrointestinal tract. Traditionally, the pathogenesis of diabetes was believed to be "yin deficiency and dryness and heat," but more recently, it has been recognized that both qi and yin deficiency, with heat stagnation and blood stasis being particularly common, particularly blood stasis, is present throughout the entire diabetic process. Therefore, treatments often focus on nourishing yin and qi, clearing heat and removing blood stasis.

[0003] Currently, the treatment of diabetes mainly relies on taking Western medicine to control blood sugar. Although Western medicine has a good blood sugar-lowering effect, long-term use can cause side effects such as hypoglycemia, gastrointestinal reactions, and damage to the cardiovascular system and kidneys. Summary of the Invention

[0004] To address the aforementioned problems in the prior art, the inventors of the present invention discovered through clinical observation that once diabetes develops, organs such as the lungs, spleen, and kidneys are already damaged in the early stages of the disease. The severity of kidney damage alone determines the severity of the "three excesses and one deficiency" symptoms, with stasis occurring throughout the entire course of the disease. Regardless of the early, mid, or late stages of diabetes, patients experience pathological manifestations of yin and yang imbalance. Therefore, the primary focus of diabetes treatment, from beginning to end, is balancing yin and yang. "When yin and yang are balanced, the spirit is healed." Based on this, the inventors of the present invention, after extensive testing and clinical analysis, have proposed a traditional Chinese medicine for the treatment or adjunctive treatment of diabetes.

[0005] The present invention provides a medicine for treating or assisting in the treatment of diabetes, wherein the medicine is prepared by containing the following components in parts by weight:

[0006] Ginseng: 15-25 parts by weight;

[0007] Rehmannia glutinosa: 52-68 parts by weight;

[0008] Scrophulariaceae: 54-65 parts by weight;

[0009] Cornus officinalis: 25-35 parts by weight;

[0010] Cuscuta australis: 51-67 parts by weight;

[0011] Atractylodes lancea: 36-45 parts by weight;

[0012] Millettia reticulata: 26-34 parts by weight;

[0013] Agrimony: 50-70 parts by weight;

[0014] Rhubarb: 21-27 parts by weight;

[0015] Cinnamon: 16-25 parts by weight;

[0016] Coptis chinensis: 35-45 parts by weight;

[0017] Leeches: 11-21 parts by weight;

[0018] Astragalus: 53-68 parts by weight;

[0019] Morus alba bark: 52-68 parts by weight;

[0020] Gypsum: 210-275 parts by weight;

[0021] Rhizoma Anemarrhenae: 25-36 parts by weight;

[0022] Salvia miltiorrhiza: 24-35 parts by weight.

[0023] The present invention also provides a method for preparing a drug for treating or assisting in the treatment of diabetes, the method comprising the following steps:

[0024] Weigh each component of the drug for treating or assisting in treating diabetes provided by the present invention according to the weight ratio of each component for later use;

[0025] Crush coptis root, rhubarb, Millettia reticulatae paste, cornus officinalis, ginseng, dodder seed, leech, and cinnamon bark, and then pass through an 80-mesh sieve to obtain a fine powder of component 1;

[0026] Grind Atractylodes lancea, Astragalus membranaceus, Morus alba bark, Rehmannia glutinosa, Scrophularia ningpoensis, Agrimoniae scabra, Gypsum Fibrosum, and Anemarrhena rhizome into coarse particles; then add 5-7 times, preferably 6 times, the amount of water to soak for 2-4 hours, preferably 3 hours, and then decoct 2-5 times, each time for 0.5 hours; filter, and concentrate the filtrate to an extract with a relative density of d=1.30, then dry at 80°C, grind again, and pass through an 80-mesh sieve to obtain a fine powder of component 2;

[0027] Mix the fine powder of component one and the fine powder of component two obtained above;

[0028] Preferably, the mixture of the fine powder of component 1 and the fine powder of component 2 is evenly mixed, and then moistened with 60% ethanol to form a soft material, and then the soft material is formed into small particles with a 20-40 mesh sieve;

[0029] More preferably, the small particles are dried at 60° C., moistened with an appropriate amount of 60% ethanol, and then tableted and packaged.

[0030] The drug provided by the present invention for treating or assisting in the treatment of diabetes can be used alone or in combination with insulin injection or oral hypoglycemic Western medicine. It has obvious therapeutic effects on diabetes and has no obvious toxic side effects, and is very suitable for promotion and use. DETAILED DESCRIPTION

[0031] To make the technical solutions, objectives and advantages of the present invention more clear, the present invention is further described in detail below through specific embodiments. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present invention and are not intended to limit the present invention.

[0032] The present invention provides a medicine for treating or assisting in the treatment of diabetes, wherein the medicine is prepared by containing the following components in parts by weight:

[0033] Ginseng: 15-25 parts by weight, for example, it can be any one of or two of 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 parts by weight, or it can be any one of 15-21, 16-22, 17-23, 18-24, 19-25, 18-22, or 19-21 parts by weight; preferably 20 parts by weight.

[0034] Rehmannia glutinosa: 52-68 parts by weight, for example, it can be any one of or a range between two of 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, and 68 parts by weight, or it can be any one of 52-62, 53-63, 54-64, 55-65, 56-66, 57-67, and 58-68 parts by weight; preferably 60 parts by weight.

[0035] Scrophulariaceae: 54-65 parts by weight, for example, it can be any one of 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65 parts by weight or a range between two of them, or it can be any one of 54-60, 55-61, 56-62, 57-63, 58-64, 59-65 parts by weight; preferably 60 parts by weight.

[0036] Cornus officinalis: 25-35 parts by weight, for example, it can be any one or two of 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 parts by weight, or it can be any one of 25-30, 26-31, 27-32, 28-33, 29-35, 30-35, and 28-33 parts by weight; preferably 30 parts by weight.

[0037] Cuscuta australis: 51-67 parts by weight, for example, it can be in the range of any one or two of 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67 parts by weight, or it can be, for example, any one of 51-61, 52-62, 53-63, 54-64, 55-65, 56-64, 57-63, 58-66, 59-67 parts by weight; preferably 60 parts by weight.

[0038] Atractylodes: 36-45 parts by weight, for example, it can be any one of 36, 37, 38, 39, 40, 41, 42, 43, 44, 45 parts by weight or a range between two of them, or it can be any one of 36-40, 37-41, 37-43, 38-42, 38-45, 39-43, 40-45 parts by weight; preferably 40 parts by weight.

[0039] Millettia reticulata: 26-34 parts by weight, for example, it can be any one of 26, 27, 28, 29, 30, 31, 32, 33, 34 parts by weight or a range between two of them, or it can be any one of 26-30, 27-31, 27-33, 28-32, 28-34, 29-33, 30-34 parts by weight; preferably 30 parts by weight.

[0040] Agrimony grosvenori: 50-70 parts by weight, for example, it can be in the range of any one or two of 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, and 70 parts by weight, or it can be, for example, any one of 50-60, 51-61, 52-62, 53-63, 54-64, 55-65, 56-66, 57-67, 58-68, 59-69, and 60-70 parts by weight; preferably 60 parts by weight.

[0041] Rhubarb: 21-27 parts by weight, for example, it can be any one of 21, 22, 23, 24, 25, 26, 27 parts by weight or a range between two of them, or it can be any one of 21-25, 22-26, 23-27, 23-25, 21-24, 22-25, 23-26 parts by weight; preferably 24 parts by weight.

[0042] Cinnamon: 16-25 parts by weight, for example, any one or two of 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25 parts by weight, or any one of 16-21, 17-22, 18-23, 19-24, 20-25, 19-21, and 18-22 parts by weight; preferably 20 parts by weight.

[0043] Coptis chinensis: 35-45 parts by weight, for example, it can be any one or two of 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, and 45 parts by weight, or it can be any one of 35-40, 36-41, 37-42, 38-43, 39-45, 40-45, and 38-42 parts by weight; preferably 40 parts by weight.

[0044] Leeches: 11-21 parts by weight, for example, any one of 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21 parts by weight, or any one of 11-17, 12-18, 13-19, 14-20, 15-21, 14-18, or 15-19 parts by weight; preferably 16 parts by weight.

[0045] Astragalus: 53-68 parts by weight, for example, it can be in the range of any one or two of 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, and 68 parts by weight, or it can be, for example, any one of 53-61, 54-62, 55-63, 56-64, 57-65, 58-66, 59-67, and 60-68 parts by weight; preferably 60 parts by weight.

[0046] Morus alba bark: 52-68 parts by weight, for example, it can be in the range of any one or two of 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69 parts by weight, or it can be, for example, any one of 52-60, 53-61, 54-62, 55-63, 56-64, 57-65, 58-66, 59-67, 60-68 parts by weight; preferably 60 parts by weight.

[0047] Gypsum: 210-275 parts by weight, for example, it can be any one of or a range between two of 210, 215, 220, 225, 230, 235, 240, 245, 250, 255, 260, 265, 270, and 275 parts by weight, or it can be any one of 210-240, 215-245, 220-250, 225-255, 230-260, 235-265, 240-270, and 245-275 parts by weight; preferably 240 parts by weight.

[0048] Anemarrhena asphodeloides: 25-36 parts by weight, for example, it can be any one or two of 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36 parts by weight, or it can be any one of 25-30, 26-31, 27-32, 28-33, 29-34, 30-36, 28-32 parts by weight; preferably 30 parts by weight.

[0049] Salvia miltiorrhiza: 24-35 parts by weight, for example, it can be any one of or a range between two of 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 parts by weight, or it can be any one of 24-30, 25-31, 26-32, 27-33, 28-34, 29-35, and 28-32 parts by weight; preferably 30 parts by weight.

[0050] In a preferred embodiment, the drug for treating or assisting in treating diabetes provided by the present invention is prepared by comprising the following components in parts by weight:

[0051] 20 parts by weight of ginseng, 60 parts by weight of prepared rehmannia, 60 parts by weight of scrophulariae, 30 parts by weight of cornus officinalis, 60 parts by weight of dodder seed, 40 parts by weight of atractylodes, 30 parts by weight of millettia reticulata, 60 parts by weight of agrimony, 24 parts by weight of rhubarb, 20 parts by weight of cinnamon bark, 40 parts by weight of coptis chinensis, 16 parts by weight of leech, 60 parts by weight of astragalus, 60 parts by weight of mulberry bark, 240 parts by weight of gypsum, 30 parts by weight of anemarrhena, and 30 parts by weight of salvia miltiorrhiza.

[0052] The above components used in the present invention are briefly described as follows:

[0053] Ginseng tastes sweet, slightly bitter and slightly warm, and enters the spleen and lung meridians. It has the functions of replenishing vital energy, nourishing the spleen and lungs, and promoting fluid production and quenching thirst. It is the "first medicine for deficiency and internal injuries". Ginseng total glycosides and ginseng polysaccharides both have the function of regulating blood sugar.

[0054] Rehmannia glutinosa (Shudiu Huang) has a sweet and bitter taste and a cold nature. It enters the heart, kidney, and liver meridians, clearing heat and cooling the blood, nourishing yin and promoting fluid production. It is commonly used for diabetes, as its rehmannia root and catalpol have hypoglycemic effects.

[0055] Scrophulariae tastes bitter, sweet and salty, and is cold in nature. It enters the lung, stomach and kidney meridians. It has the functions of clearing away heat and detoxifying, nourishing yin and increasing fluid, and is an important medicine for nourishing yin and reducing fire.

[0056] Ginseng, Rehmannia glutinosa and Scrophularia ningpoensis are the main medicines, which have the triple effects of invigorating qi, nourishing yin and clearing away heat. They are targeted at the pathogenesis of "yin deficiency and dryness" in diabetes mellitus, and take into account the lungs, stomach and kidneys, and treat the upper, middle and lower parts of diabetes mellitus.

[0057] Cornus officinalis tastes sour, astringent, and slightly warm in nature. It enters the liver and kidney meridians. It is warm but not dry, and nourishing but not harsh. It nourishes the kidney yang and the liver and kidney yin.

[0058] Cuscuta seeds are pungent, sweet, and neutral in nature. They enter the liver and kidney meridians, are neither warm nor dry, and have the functions of nourishing the kidneys and replenishing essence, nourishing the liver, and improving eyesight.

[0059] Atractylodes lancea is pungent, bitter, and warm in nature. It enters the spleen and stomach meridians and is known for its ability to dry dampness and strengthen the spleen. Diabetes is primarily caused by kidney yin deficiency, so Cornus officinalis and Cuscuta chinensis are used to tonify both kidney yin and kidney yang. The spleen, the foundation of acquired constitution, favors dryness and dislikes dampness. Drying dampness and strengthening the spleen promote healthy spleen function. Cornus officinalis, Cuscuta chinensis, and Atractylodes lancea serve as assistant herbs, assisting the main herbs in nourishing the kidneys and strengthening the spleen. Furthermore, Atractylodes lancea and Scrophularia ningpoensis were a favorite pairing used by the renowned modern physician Shi Jinmo in treating diabetes. Their combined use enhances their blood sugar-lowering effects.

[0060] Millettia reticulata tastes bitter and sweet, and is warm in nature. It can nourish blood, activate blood circulation, and also has the function of dredging meridians.

[0061] Agrimony Root is bitter, astringent and mild in nature. It enters the lung, liver and spleen meridians. It has both hemostatic and strengthening effects, hence the name "Weakness Grass". It can treat fatigue and strain. Modern studies have shown that it has the effect of lowering blood sugar.

[0062] Rhubarb is bitter and cold in nature, entering the spleen, stomach, large intestine, liver, and heart meridians. Its benefits include purging heat and toxins, clearing stagnation, and dispelling blood stasis. Long-standing thirst can lead to internal heat and stasis, so rhubarb and Millettia reticulata paste are used to clear heat and dissolve stasis. This, in turn, promotes blood circulation. To prevent blood stasis, Millettia reticulata's dual effects of invigorating and replenishing blood, combined with Agrimoniae's hemostatic and strengthening properties, effectively dispel stasis without damaging blood, and eliminate pathogenic factors without harming the body. Millettia reticulata, Agrimoniae, and rhubarb serve as adjuvants, ensuring that the main and secondary tonics are nourishing without stagnation, ensuring a lively and unobstructed flow.

[0063] Cinnamon tastes spicy and sweet, and is hot in nature. It enters the kidney, spleen, heart, and liver meridians. It is good at warming the kidneys and spleen, warming the meridians and dredges the blood vessels, and can guide fire back to its origin.

[0064] Coptis chinensis (Coptis chinensis) is bitter and cold in nature, entering the heart, liver, stomach, and large intestine meridians. It clears heat and dampness, purges fire and detoxifies, and its coptisine has a blood sugar-lowering effect. Cinnamon bark and coptis chinensis combine to form Jiaotai Pills, which bridge the heart and kidneys, balancing water and fire; they serve as guiding agents. This formula combines both cold and heat, attacking and tonifying. It cools without damaging yang, heats without depleting yin, attacks without damaging the vital energy, and tonifies without clinging to the negative energy, thus achieving a yin-yang balancing effect.

[0065] The present invention also provides a method for preparing the above-mentioned medicine for treating or assisting in treating diabetes, comprising the following steps:

[0066] Weigh each component according to the above weight ratio requirements for use;

[0067] Crush coptis root, rhubarb, Millettia reticulatae paste, cornus officinalis, ginseng, dodder seed, leech, and cinnamon bark, and then pass through an 80-mesh sieve to obtain a fine powder of component 1;

[0068] Grind Atractylodes lancea, Astragalus membranaceus, Morus alba bark, Rehmannia glutinosa, Scrophularia ningpoensis, Agrimoniae scabra, Gypsum Fibrosum, and Anemarrhena rhizome into coarse particles; then add 5-7 times (preferably 6 times) the amount of water and soak for 2-4 hours (preferably 3 hours), then decoct 2-5 times (preferably 3 times), each time for 0.5 hours; filter, and concentrate the filtrate to an extract with a relative density of d=1.30 (measured at 50°C), then dry at 80°C, grind and pass through an 80-mesh sieve to obtain a fine powder of component 2;

[0069] The medicine for treating or assisting in treating diabetes can be obtained by uniformly mixing the fine powder of component one and the fine powder of component two obtained above.

[0070] Furthermore, for the convenience of taking, the mixture obtained by mixing the fine powder of the above-mentioned component one and the fine powder of the component two can be moistened with 60% ethanol to form a soft material, and then the soft material can be made into small particles with a 20-40 mesh sieve; and further, the above-mentioned small particles can be dried at 60°C, moistened with an appropriate amount of 60% ethanol, and then tableted and packaged to obtain pharmaceutical tablets for the treatment or auxiliary treatment of diabetes.

[0071] The medicine provided by the present invention for treating or assisting in the treatment of diabetes, based on the principle of yin and yang balance, uses ginseng, rehmannia glutinosa, and Scrophularia ningpoensis as the main herbs, and has the effects of replenishing qi and nourishing yin, as well as clearing away heat. It hits the pathogenesis of diabetes mellitus characterized by "yin deficiency and dryness and heat" and takes into account the lungs, spleen, and kidneys, treating the upper, middle, and lower parts of the body simultaneously. Diabetes mellitus is based on kidney yin deficiency and impaired spleen function. Therefore, Cornus officinalis and Cuscuta chinensis can replenish kidney yin and kidney yang without being warm or dry, replenishing both yin and yang. Atractylodes macrocephala can eliminate dampness and strengthen the spleen, thereby strengthening spleen function. Because blood stasis runs through the entire pathological process and stasis and heat are intertwined, Millettia reticulata paste, rhubarb, and Agrimony Root are used as adjuvants to clear away heat and resolve stasis. When stasis is removed, blood vessels are unobstructed. However, there is a concern that blood will be damaged. Therefore, herbs that replenish blood and stop bleeding are used among the adjuvants to remove stasis without damaging blood and to dispel pathogenic factors without damaging the body. The three adjuvants can also make the main herbs nourishing without stagnation, and the medicinal properties are lively and smooth. The guiding herbs cinnamon and coptis root connect the heart and kidneys, bringing water and fire into harmony. The purpose of aconite root is to invigorate yang and unclog the twelve meridians. The entire formula uses both cold and heat, attacking and tonifying simultaneously. It cools without damaging yang, heats without depleting yin, attacks without harming the body's health, and tonifies without clinging to negative factors, thus achieving a yin-yang balancing agent with considerable clinical efficacy.

[0072] The medicine provided by the present invention for treating or assisting the treatment of diabetes can strengthen the spleen and kidney, replenish qi and nourish yin, promote blood circulation and remove blood stasis, lower blood sugar and eliminate fat. It is suitable for the treatment or assisting the treatment of non-insulin-dependent diabetes, and can also be used for the treatment or assisting the treatment of insulin-dependent diabetes.

[0073] Unless otherwise specified, the various reagents, materials, etc. used in the following examples are all products that can be obtained from commercial channels; unless otherwise specified, the various tests and detection methods used in the following examples are all conventional tests and detection methods in the field, which can be obtained from textbooks, reference books or academic journals.

[0074] Example 1

[0075] This example is used to illustrate the preparation of the drug for treating or assisting in treating diabetes provided by the present invention.

[0076] Weigh 2kg of ginseng, 6kg of rehmannia, 6kg of figwort, 3kg of cornus officinalis, 6kg of dodder seed, 4kg of atractylodes, 3kg of millettia reticulata, 6kg of agrimony, 2.4kg of rhubarb, 2kg of cinnamon bark, 4kg of coptis chinensis, 1.6kg of leech, 6kg of astragalus, 6kg of mulberry bark, 24kg of gypsum, 3kg of anemarrhena, and 3kg of salvia miltiorrhiza for later use.

[0077] Crush coptis root, rhubarb, Millettia reticulatae paste, cornus officinalis, ginseng, dodder seed, leech, and cinnamon bark, and then pass through an 80-mesh sieve to obtain a fine powder of component 1;

[0078] Grind Atractylodes lancea, Astragalus membranaceus, Morus alba bark, Rehmannia glutinosa, Scrophularia ningpoensis, Agrimoniae scabra, Gypsum Fibrosum, and Anemarrhena rhizome into coarse particles; then add 6 times the amount of water and soak for 3 hours, then decoct three times, each time for 0.5 hours; filter, and concentrate the filtrate to an extract with a relative density of d=1.30 (measured at 50°C), then dry at 80°C, grind again, and pass through an 80-mesh sieve to obtain a fine powder of component 2;

[0079] The fine powder of component one and the fine powder of component two obtained above are mixed, moistened with 60% ethanol to form a soft material, and then the soft material is made into small particles with a 20-40 mesh sieve; after the small particles are dried at 60°C, an appropriate amount of 60% ethanol is added to moisten them, and then tablets are pressed and packaged to obtain pharmaceutical tablets for the treatment or auxiliary treatment of diabetes (hereinafter referred to as "hyperglycemic tablets"), each tablet weighing 0.3 g (the weight content of ethanol and water is not higher than 5%).

[0080] Example 2

[0081] This example is used to illustrate the therapeutic effect of the drug for treating or assisting in the treatment of diabetes provided in Example 1 of the present invention on diabetes.

[0082] Informed consent and medical ethics requirements: (1) Before starting the trial, the researcher should submit the trial plan to the ethics committee for approval, and the trial can only be implemented after approval. (2) This study must comply with the provisions of the Declaration of Helsinki and follow the Good Clinical Practice (GCP) guidelines of my country. Before the start of the clinical trial plan, the subjects must sign a written informed consent form. The patients participating in the trial are as follows:

[0083] Of the 68 patients, 42 were hospitalized and 26 were outpatients; 41 were male and 27 were female; their ages ranged from 31 to 78 years, with an average age of 51.2 years. The shortest duration of illness was 3 months, and the longest was 21 years. Among the 68 patients, 61 had non-insulin-dependent diabetes and 7 had insulin-dependent diabetes. Six had diabetic ketoacidosis, 12 had diabetic cataracts, 5 had diabetic gangrene, 4 had diabetic heart disease, 3 had early diabetic nephropathy, 7 had diabetic peripheral neuritis, and 36 had hyperlipidemia. Seven of the 68 patients were receiving insulin injections, 38 were taking oral hypoglycemic medications (metformin or glimepiride), and 23 were not taking any medications.

[0084] Treatment options include:

[0085] Group 1: Patients receiving insulin injection therapy should continue taking the same insulin dosage and take 8-12 tablets of the hypoglycemic tablets prepared in Example 1 three times a day, 20 minutes before meals. The insulin dosage should be gradually reduced based on blood sugar levels. One month is a course of treatment. Patients with more severe conditions should take an additional dose before bed.

[0086] Group 2: Patients taking oral hypoglycemic medication continued to maintain their original dosage of hypoglycemic medication and additionally took 8-12 hypoglycemic tablets prepared in Example 1, 20 minutes before meals, three times a day. The dosage of oral hypoglycemic medication was gradually reduced or discontinued based on blood sugar levels. A course of treatment consisted of one month. Patients with more severe conditions took an additional dose before bed.

[0087] The third group: patients who did not take any other medications took 10-14 tablets of the hypoglycemic tablets prepared in Example 1, 20 minutes before meals, three times a day. One month was a course of treatment. Patients with more serious conditions took an additional dose before bedtime.

[0088] Among the above patients, those with diabetic ketoacidosis and diabetic gangrene should receive corresponding other symptomatic treatments at the same time.

[0089] The following conditions of each patient were observed and counted: improvement of main clinical symptoms; discontinuation of insulin injection or oral hypoglycemic western medicine (as shown in Table 1); fasting blood sugar and blood sugar 2 hours after meal before and after treatment with the hypoglycemic tablets prepared in Example 1, and blood sugar index was tested using t test.

[0090] Table 1 Discontinuation and reduction of insulin injection and oral hypoglycemic drugs

[0091] Number of patients Before treatment Discontinuation of medication after treatment (%) Dose reduction after treatment (%) Group 1 7 7 2(28.6％) 5(71.4％) Group 2 38 38 7(18.4％) 31(81.6％)

[0092] The results showed that, as shown in Table 1, among the 45 patients who were taking insulin injections (Group 1) and oral hypoglycemic drugs (Group 2), 5 patients reduced their insulin dosage (Group 1) and 31 patients reduced their oral hypoglycemic drugs (Group 2). 9 patients stopped taking oral drugs.

[0093] Among the 68 patients, 52 (2 in Group 1, 22 in Group 2, and 28 in Group 3) had obvious symptoms of "three mores and one less." After one course of treatment with the aforementioned three-group treatment regimen, these symptoms disappeared, and their weight stabilized or increased to varying degrees. Sixteen patients (1 in Group 1, 8 in Group 2, and 7 in Group 3) did not have obvious "three mores and one less" symptoms, but experienced fatigue, limb pain, and numbness. These symptoms were alleviated after one course of treatment with the aforementioned three-group treatment regimen. Six feet of five patients with diabetic foot (1 in Group 1, 2 in Group 2, and 2 in Group 3) healed, except for one case of bilateral gangrene and one amputation due to severe necrosis.

[0094] After one course of treatment, fasting and 2-hour postprandial blood glucose (unit: mmol / L) were significantly reduced. For the third group of patients who did not take any medication, blood glucose improved significantly after oral administration of the hypoglycemic tablets prepared in Example 1, and the comparison before and after treatment was statistically significant (as shown in Table 2).

[0095] Table 2 Changes in fasting and 2 hours postprandial blood sugar levels before and after treatment

[0096]

[0097] It can be seen that the drug for treating or assisting in the treatment of diabetes provided by the present invention, whether used in conjunction with insulin injection or oral hypoglycemic Western medicine, or used alone, has a significant and effective therapeutic effect on diabetes, and has a significant effect on improving blood sugar and improving diabetic complications.

[0098] Comparative Example

[0099] In the following comparative examples, in order to save the amount of medicinal materials and reduce costs, the amount of each component used in Example 1 was reduced to one percent of the amount used in Example 1. For example, if the amount of Rehmannia glutinosa in Example 1 was 6 kg, the amount of Rehmannia glutinosa in the following comparative examples was 60 g.

[0100] Except for the differences listed in Table 3 below, everything else is the same as Example 1.

[0101] Table 3 Comparative Examples (differences from Example 1)

[0102]

[0103] The same method as in Example 1 was used to prepare the drugs in Comparative Examples 1-5. Then, according to the method in Example 2, 10 patients were selected from each group (each patient had symptoms of "three mores and one less", and there were 2 cases of diabetic foot in each group). The drugs were used to treat diabetes according to the treatment plan for the third group in Example 2, and each course of treatment lasted one month.

[0104] After one course of treatment, the therapeutic effects of Comparative Examples 1-5 are as follows:

[0105] Among the 10 patients in comparison example 1, only 30% of the patients had their "three mores and one less" symptoms disappear; the symptoms of the two cases of diabetic foot did not improve significantly.

[0106] Among the 10 patients in comparison group 2, only 40% of the patients had their "three mores and one less" symptoms disappear; the symptoms of the two cases of diabetic foot did not improve significantly.

[0107] Among the 10 patients in comparison group 3, only 20% of the patients had their "three mores and one less" symptoms disappear; the symptoms of 2 cases of diabetic foot did not improve significantly.

[0108] Among the 10 patients in comparison example 4, only 20% of the patients had their "three mores and one less" symptoms disappear; the symptoms of 2 cases of diabetic foot did not improve significantly.

[0109] Among the 10 patients in comparison group 5, none of the “three mores and one less” symptoms disappeared; the symptoms of two cases of diabetic foot showed obvious deterioration.

[0110] It can be seen from the above Examples 1-2 and Comparative Examples 1-5 that the use of the medicine provided by the present invention has a significant therapeutic effect on diabetes, can significantly improve the symptoms of diabetic patients, and improve the quality of life of diabetic patients; moreover, among the medicines provided by the present invention for treating or assisting in the treatment of diabetes, the dosage of ginseng is the most important. If the dosage of ginseng is reduced or increased, the therapeutic effect on diabetes will be greatly reduced; in addition, the dosage of Scrophularia and Rehmannia prepared, as well as the matching of the dosage of Scrophularia, Rehmannia prepared and ginseng are also very important. Increasing or decreasing the dosage of Scrophularia and the dosage ratio of Scrophularia, Rehmannia prepared and ginseng will also significantly reduce the efficacy of diabetes.

[0111] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A drug for treating or assisting in treating the symptoms of diabetes mellitus "three mores and one less" and diabetic foot, characterized in that: The medicine is prepared by using the following components in parts by weight: 20 parts by weight of ginseng, 60 parts by weight of prepared rehmannia, 60 parts by weight of scrophulariae, 30 parts by weight of cornus officinalis, 60 parts by weight of dodder seed, 40 parts by weight of atractylodes, 30 parts by weight of millettia reticulata, 60 parts by weight of agrimony, 24 parts by weight of rhubarb, 20 parts by weight of cinnamon bark, 40 parts by weight of coptis chinensis, 16 parts by weight of leech, 60 parts by weight of astragalus, 60 parts by weight of mulberry bark, 240 parts by weight of gypsum, 30 parts by weight of anemarrhena, and 30 parts by weight of salvia miltiorrhiza.

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