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

Abstract

The invention discloses a Chinese medicine composition for treating diabetes and its preparation method and application, which belongs to the field of traditional Chinese medicine technology. The Chinese medicine composition is composed of the following raw materials in parts by weight: 30-45 parts of Chaga, 20-30 parts of Pueraria, 20-30 parts of Radix Trichosanthis, 20-30 parts of Gallus Gallus Ternifolia, 10-15 parts of Radix Scutellariae and 10-15 parts of Radix Salviae Miltiorrhizae. The present invention sets out from lowering blood sugar, correcting insulin resistance and improving body immunity, selects Chaga and other five Chinese medicinal materials, and proposes an effective drug combination according to the theory of "monarch, minister, assistant and envoy" of traditional Chinese medicine. The Chinese medicine composition can effectively reduce blood sugar content and correct insulin resistance. At the same time, it can repair and improve pancreatic function to a certain extent, is remarkable in promoting diabetes rehabilitation effect, and has no toxic side effects to human body, and has significant clinical promotion value.

Description

Technical Field

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

[0002] Diabetes is a chronic systemic metabolic disease characterized by elevated blood sugar. It is a progressive metabolic disease caused by dysregulation of insulin secretion or impaired biological action, or both. It is characterized by chronic hyperglycemia and is primarily affected by genetic and environmental factors. It is a chronic endocrine disease syndrome often accompanied by elevated blood lipids.

[0003] As the disease progresses, it will affect the heart, brain, kidneys, eyes, nervous system and lower limb blood vessels, and even threaten the patient's life. Western medicine often uses oral hypoglycemic drugs to treat diabetes, but diabetes is a complex disease. Its occurrence and development are related to many factors. The overall efficacy of Western medicine alone is poor, and the blood sugar control effect is not stable enough. It may even cause adverse reactions such as hypoglycemia, nausea, vomiting, abdominal distension, and dizziness. Type 2 diabetes belongs to the category of "xiaoke", "xiaolan" and "pilan" in traditional Chinese medicine. The disease is based on yin deficiency and dryness and heat as symptoms. Traditional Chinese medicine believes that the causes of diabetes are as follows: (1) Improper diet: Currently, people are keen on fatty and greasy foods, which affects the normal function of the spleen and stomach, causing dampness and heat in the stomach, and dryness and heat in the body. Excessive heat damages yin, which is called xiaoke; (2) Emotional disorders: Mainly due to excessive psychological pressure, large emotional fluctuations, and brain tension, which can damage the normal function of the spleen; (3) Excessive work and desire: Sexual work damages the kidneys, physical work damages the spleen, and mental work damages both the liver and spleen. (4) Congenital endowment: This mainly refers to family heredity. People with a family history of diabetes are more likely to develop the disease. Due to the long-term influence of the disease, the yin and yang of the internal organs are out of balance, with yang being strong and yin being weak. Over time, the heat is excessive, which consumes body fluids, and qi and yin are insufficient, resulting in thirst and excessive drinking, which leads to diabetes. The treatment of diabetes with traditional Chinese medicine has been recorded for a long time, with a long history of use and a mature theoretical system. It can start from the cause and pathogenesis, treat the disease holistically, and achieve the goal of eradication. In addition, traditional Chinese medicine has few side effects in treating diabetes, and is highly accepted by patients, and is gradually gaining attention. Based on this, the present invention provides a traditional Chinese medicine composition that is effective in treating diabetes. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating diabetes, and a preparation method and application thereof, in order to solve the problems existing in the above-mentioned prior art. The present invention proposes a traditional Chinese medicine composition for treating diabetes based on the theory of "monarch, minister, assistant and envoy" in traditional Chinese medicine. The traditional Chinese medicine composition can effectively lower blood sugar content and correct insulin resistance. At the same time, it can repair and improve pancreatic function to a certain extent, has a significant effect on promoting the recovery of diabetes, and has no toxic side effects on the human body, and has significant clinical promotion value.

[0005] To achieve the above object, the present invention provides the following solutions:

[0006] The invention provides a traditional Chinese medicine composition for treating diabetes. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30-45 parts of Chaga, 20-30 parts of Pueraria root, 20-30 parts of Radix Trichosanthis, 20-30 parts of Gallus domestica, 10-15 parts of Scutellaria baicalensis and 10-15 parts of Salvia miltiorrhiza.

[0007] Furthermore, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 45 parts of Chaga, 30 parts of Pueraria, 30 parts of Radix Trichosanthis, 30 parts of Gallus gallus domesticus, 15 parts of Scutellaria baicalensis, and 15 parts of Salvia miltiorrhiza.

[0008] The present invention also provides a method for preparing a traditional Chinese medicine composition for treating diabetes, comprising the following steps:

[0009] Cutting the Chaga into pieces, drying them, and micronizing them to obtain ultrafine Chaga powder;

[0010] A mixture of kudzu root, trichosanthes root, chicken's gizzard lining, scutellaria baicalensis and salvia miltiorrhiza is decocted with water, filtered and concentrated into a clear paste; ethanol is added and stirred, allowed to stand, filtered and concentrated into an extract to obtain a Chinese medicine extract;

[0011] The chaga superfine powder and the traditional Chinese medicine extract are mixed, dried, and powdered to obtain the traditional Chinese medicine composition.

[0012] Furthermore, the amount of water used for decoction is 8-10 times the weight of the mixed medicinal materials, and the decoction is performed twice, each time for 1-2 hours.

[0013] Furthermore, ethanol is added until the clear paste contains 60 vol% ethanol, and then stirred evenly.

[0014] Furthermore, the conditions for drying the Chaga superfine powder and the Chinese medicine extract after mixing are 40° C. and 30 minutes.

[0015] The present invention also provides use of the above-mentioned traditional Chinese medicine composition in preparing medicine for treating diabetes.

[0016] The present invention also provides a medicine for treating diabetes, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0017] Furthermore, the dosage form of the medicine includes granules.

[0018] The prescription of the Chinese medicine composition of the present invention is as follows:

[0019] Chaga, also known as Inonotus obliquus, is a brown polypore fungus belonging to the family Oleaceae. It is a saprophytic fungus that parasitizes white and silver birch trees. Chaga contains over 200 different types of bioactive components, primarily inonotol, polysaccharides, triterpenes, flavonoids, sterols, polyphenols, and melanin. Chaga extract significantly lowers blood sugar and has anti-diabetic properties. Low-molecular-weight chaga polysaccharides can also combat high-fat diet-induced nephropathy and hyperlipidemia. Chaga extract also has anti-tumor and anti-inflammatory applications. According to traditional Chinese medicine, it is sweet in taste and neutral in nature. It enters the lung, spleen and kidney meridians, and has the functions of invigorating qi and nourishing yin, clearing away heat and detoxifying, promoting blood circulation and dispersing stagnation. It is mainly aimed at the main symptoms of diabetes mellitus, namely "yin deficiency" and "dryness and heat", so it is the monarch medicine; Pueraria root is sweet, pungent and cool, and has the functions of relieving muscles and reducing fever, promoting rash, promoting fluid production and quenching thirst, and raising yang. It can help Chaga to invigorate qi and raise yang, regulate the balance of yin and yang, nourish yin and not weaken yang, distribute fluid and quench thirst; Radix Trichosanthis is bitter, slightly sweet and cold, and enters the lung and stomach meridians, and has the functions of clearing heat and promoting fluid production; Chicken gizzard lining is sweet and neutral, and enters the spleen, stomach, small intestine and bladder meridians, and has the functions of moving the spleen and digesting food, consolidating essence and stopping nocturnal emission. These three herbs act as assistants, supporting Chaga's ability to nourish Yin, clear heat, and invigorate the spleen. Scutellaria baicalensis, bitter and cold, enters the lung, liver, stomach, and large intestine meridians, clearing heat and dampness, purging fire and detoxifying. Salvia miltiorrhiza, bitter and slightly warm, enters the heart and liver meridians, promoting blood circulation and removing stasis, calming the mind, draining pus, and relieving pain. These two herbs act as assistants, one to treat stasis and the other to treat heat.

[0020] The present invention discloses the following technical effects:

[0021] The present invention is guided by the basic theories of traditional Chinese medicine, based on a holistic approach, and focuses on patients with diabetes mellitus as the primary research subjects. Based on the theories of "yin deficiency as the root, dryness and heat as the symptom," "long-term illness leads to deficiency," and "long-term illness leads to blood stasis," the main treatment methods are to invigorate qi and nourish yin, clear away heat and moisten dryness, and dispel blood stasis and resolve stagnation. The present invention provides a traditional Chinese medicine composition for treating diabetes, comprising chaga, kudzu root, trichosanthes root, chicken's gizzard lining, scutellaria baicalensis, and salvia miltiorrhiza. Through rational compatibility, the whole formula uses chaga as the monarch drug, kudzu root, trichosanthes root, and chicken's gizzard lining as minister drugs, and scutellaria baicalensis and salvia miltiorrhiza as adjuvant drugs, conforming to the "monarch, minister, adjuvant, and adjuvant" compatibility treatment principle. The present invention is comprehensive in theory, method, prescription, and drugs, and has definite clinical efficacy. While strengthening the body's health (for the root cause), it also emphasizes dispelling pathogenic factors (for the symptom). It has significant advantages in eliminating symptoms such as thirst, fatigue, spontaneous sweating, shortness of breath and laziness, controlling blood sugar, restoring pancreatic function, reducing inflammatory factors, preventing complications, and improving quality of life. DETAILED DESCRIPTION

[0022] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0023] It should be understood that the terms described herein are intended only to describe particular embodiments and are not intended to limit the present invention. In addition, for numerical ranges herein, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. The intermediate value within any stated value or stated range, and each smaller range between any other stated value or intermediate value within the stated range, is also encompassed within the present invention. The upper and lower limits of these smaller ranges may be independently included or excluded within the scope.

[0024] Unless otherwise indicated, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein may also be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of any conflict with any incorporated document, the contents of this specification shall prevail.

[0025] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art from the description of the invention. The description and examples are intended to be illustrative only.

[0026] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0027] Example 1

[0028] A traditional Chinese medicine composition for treating diabetes comprises the following raw materials in parts by weight: 45 parts of Chaga, 30 parts of Pueraria root, 30 parts of Radix Trichosanthis, 30 parts of Gallus gallus domesticus, 15 parts of Scutellaria baicalensis, and 15 parts of Salvia miltiorrhiza.

[0029] The chaga mushroom pieces are dried at 55-65°C, then broken and pulverized in an ultra-low temperature mill at -10°C for micronization to a mesh size of 1000-10000 to obtain chaga mushroom ultrafine powder. The raw materials Pueraria root, Radix Trichosanthis, Gallus gallus officinalis, Radix Scutellariae, and Salvia miltiorrhizae are decocted twice with water, each time using 8-10 times the weight of the medicinal materials, for 1-2 hours each time. The decocted liquid is filtered and concentrated into a clear paste having a relative density of 1.10-1.25 measured at 60-65°C. Ethanol is added to a concentration of 60% by volume, stirred, and allowed to stand for 24 hours. The mixture is filtered, and the filtrate is concentrated into an extract containing 60-65% by weight of solids after ethanol is recovered to obtain a Chinese herbal medicine extract. The chaga mushroom ultrafine powder and the Chinese herbal medicine extract are mixed and the mixture is dried in a vacuum microwave drying oven at 40°C for 30 minutes. The mixture is powdered and processed into granules, with each small package containing 3g of the Chinese herbal medicine composition.

[0030] Example 2

[0031] A traditional Chinese medicine composition for treating diabetes comprises the following raw materials in parts by weight: 37.5 parts of Chaga, 25 parts of Pueraria root, 25 parts of Radix Trichosanthis, 25 parts of Gallus gallus domesticus, 12.5 parts of Scutellaria baicalensis, and 12.5 parts of Salvia miltiorrhiza.

[0032] The preparation method is the same as that of Example 1.

[0033] Example 3

[0034] A traditional Chinese medicine composition for treating diabetes comprises the following raw materials in parts by weight: 30 parts of Chaga, 20 parts of Pueraria root, 20 parts of Radix Trichosanthis, 20 parts of Gallus gallus domesticus, 10 parts of Scutellaria baicalensis, and 10 parts of Salvia miltiorrhiza.

[0035] The preparation method is the same as that of Example 1.

[0036] Comparative Example 1

[0037] The same as Example 1, the only difference is that the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 45 parts of Pueraria root, 30 parts of Chaga mushroom, 30 parts of Radix Trichosanthis, 30 parts of Gallus gallus domesticus, 15 parts of Scutellaria baicalensis, and 15 parts of Salvia miltiorrhiza.

[0038] Comparative Example 2

[0039] The same as Example 1, the only difference is that the Chinese medicine composition includes the following raw materials in parts by weight: 45 parts of tartary buckwheat, 30 parts of kudzu root, 30 parts of trichosanthes, 30 parts of chicken's gizzard lining, 15 parts of scutellaria, and 15 parts of salvia miltiorrhiza.

[0040] Comparative Example 3

[0041] The same as Example 1, except that the preparation method of the Chinese medicine composition is as follows: weighing a specified amount of Chaga, Pueraria, Radix Trichosanthis, Gallus Gallus Ternifolia, Radix Scutellariae, and Salvia miltiorrhiza, decocting with water twice, each time with water 8-10 times the weight of the medicinal materials, decocting twice, each time for 1-2 hours, filtering, and concentrating the filtrate into a clear paste having a relative density of 1.10-1.25 measured at 60-65°C, adding ethanol to contain 60 vol%, stirring, standing for 24 hours, filtering, recovering ethanol, and concentrating the filtrate into an extract containing 60-65% by weight of solids, placing the extract in a vacuum microwave drying oven, drying at 40°C for 30 min, powdering, and processing into granules to obtain a Chinese medicine composition of 3 g per small packet.

[0042] Example 4 Effect Verification Test

[0043] 1. General Information

[0044] A total of 150 patients were observed, including 78 males and 72 females. The oldest was 76 years old and the youngest was 24 years old. The disease course was 1-4 years.

[0045] 2. Inclusion criteria

[0046] Those who meet the diabetes diagnostic criteria proposed in the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)"; meet the Qi and Yin deficiency syndrome type in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes", with little or white fur, red tongue, and weak and rapid pulse; those with fasting blood sugar less than 9mmol / L and who are temporarily not in need of Western medicine treatment after diagnosis and treatment by a professional doctor.

[0047] 3. Exclusion criteria

[0048] Patients with malignant tumors; patients who are intolerant to the study drugs; patients with impaired consciousness or mental illness.

[0049] 4. Treatment Methods

[0050] 150 diabetic volunteers were randomly divided into four experimental groups and one control group. The control group received appropriate physical exercise, active prevention and treatment of complications, and diversified health education. In addition to the control group, the four experimental groups received oral treatment with the Chinese herbal granules prepared in Example 1 and Comparative Examples 1-3, three times daily, 3 g each time, for a four-week course. Efficacy evaluation was performed after four weeks.

[0051] 5. Efficacy standards

[0052] According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs (Trial)", the basis for evaluating efficacy is: blood sugar levels tend to normal, and the TCM syndrome score is reduced by 75%-95%, which is considered significant effect; blood sugar levels tend to normal, and the TCM syndrome score is reduced by 50%-74%, which is considered effective; blood sugar levels do not reach the standard and the TCM syndrome score is reduced by less than 50%, which is considered ineffective.

[0053] Total effective rate = (number of effective patients + number of effective patients) / total number of patients × 100%.

[0054] According to the "Chinese Medicine Symptom Score Table", it mainly includes nine indicators: fatigue, spontaneous sweating, shortness of breath, shortness of breath, weight loss, fever in the five hearts, dry mouth and throat, insomnia, and numbness of limbs. According to their severity, they are divided into four levels: none (0 points), mild (1 point), moderate (3 points) and severe (5 points). After the scoring is completed, the total score is calculated as the Chinese Medicine Symptom Score.

[0055] Table 1 Scoring criteria for the TCM symptom scoring scale

[0056] Traditional Chinese Medicine symptoms None (0 points) Mild (1 point) Moderate (3 points) Severe (5 points) fatigue none The limbs are slightly tired and can complete light physical labor Weakness in the limbs, only able to complete daily activities All day, general fatigue, no desire to move spontaneous sweating none Skin is slightly moist moist skin Sweating Short temper and lazy none Don't like to talk too much Too lazy to speak No words shortness of breath none Shortness of breath after activity Shortness of breath with slight movement Shortness of breath without moving Thin body none Mild weight loss Moderately thin body Extremely thin body Five Hearts of Heat none Fever in the palms and soles Hands and feet want to be exposed outside the clothes Hands and feet feel comfortable holding cold objects Dry mouth and throat none Mild dry mouth and throat Dry mouth and throat, which can be relieved by drinking water Dry mouth and throat, wanting to drink water but unable to get relief Insomnia none Waking up easily or having restless sleep, waking up too early in the morning, but not affecting work Sleep less than 4 hours a day, but can still work Sleepless nights and difficulty maintaining normal work limb numbness none Occasionally Occurs frequently and can be relieved Occurs frequently and is difficult to relieve

[0057] 6. Data statistical processing

[0058] SPSS 23.0 software was used for statistical analysis, and the measurement data were analyzed by ( ), enumeration data were expressed as rate (%), and χ 2 When P < 0.05, the difference was statistically significant.

[0059] 7. Results

[0060] 7.1 Comparison of overall effective rate

[0061] As shown in Table 2, the total effective rate of the Chinese medicine composition prepared in Example 1 was as high as 100%, significantly higher than that of the control group. However, the efficacy of Comparative Examples 1-3 was significantly reduced due to changes in the types of monarch and ministerial drugs or changes in the preparation methods of the medicine, and there were statistical differences compared with Example 1.

[0062] Table 2 Comparison of total effective rate

[0063] Group Number of cases Significant effect efficient invalid Total effective rate (%) control group 30 7（23.3%） 11（36.7%） 12（40%） <![CDATA[60.5 a ]]> Example 1 30 25（83.3%） 5（16.7%） 0（0%） <![CDATA[100 ab ]]> Comparative Example 1 30 15（50.0%） 11（36.7%） 4（13.3%） <![CDATA[86.7 ab ]]> Comparative Example 2 30 15（50.0%） 12（40.0%） 3（10.0%） <![CDATA[90 ab ]]> Comparative Example 3 30 17（56.7%） 9（30.0%） 4（13.3%） <![CDATA[86.7 ab ]]>

[0064] Note: Different letters indicate statistically significant differences.

[0065] 7.2 Comparison of symptom scores before and after treatment

[0066] As shown in Table 3, there was no statistical difference in the TCM symptom scores before treatment. After treatment with the Chinese medicine composition prepared in Example 1, the symptom scores decreased significantly. The symptom scores of Comparative Examples 1-3 were all higher than those of Example 1, and there were statistical differences compared with Example 1.

[0067] Table 3 Comparison of symptom scores before and after treatment

[0068] Group Number of cases Before treatment After treatment control group 30 <![CDATA[22.51±5.31 a ]]> <![CDATA[15.64±3.02 a ]]> Example 1 30 <![CDATA[22.07±4.98 a ]]> <![CDATA[8.29±3.27 ab ]]> Comparative Example 1 30 <![CDATA[21.78±6.21 a ]]> <![CDATA[10.22±2.97 ab ]]> Comparative Example 2 30 <![CDATA[23.01±5.46 a ]]> <![CDATA[11.02±2.76 ab ]]> Comparative Example 3 30 <![CDATA[22.01±5.45 a ]]> <![CDATA[10.02±3.06 ab ]]>

[0069] Note: Different letters indicate statistically significant differences.

[0070] 7.3 Comparison of fasting blood glucose before and after treatment

[0071] As shown in Table 4, there was no difference in fasting blood glucose (FPG) before treatment; after treatment, the FPG of the Chinese medicine composition prepared in Example 1 was significantly reduced, while the FPG of Comparative Examples 1-3 were all higher than that of Example 1, and there were statistical differences compared with Example 1.

[0072] Table 4 Comparison of FPG between the two groups

[0073]

[0074] Note: Different letters indicate statistically significant differences.

[0075] 7.4 Safety Analysis of Clinical Application

[0076] During the clinical application process, we always pay attention to the safety observation of this prescription. No patients have experienced rashes or other allergic reactions or adverse reactions. Long-term use shows that this prescription is safe and reliable in clinical application.

[0077] Clinical use analysis shows that this formula has a wide range of clinical users, good clinical efficacy, obvious symptom improvement, no toxic side effects, and a 100% efficacy in the treatment of diabetes, and is worthy of promotion and application.

[0078] The embodiments described above are merely descriptions of preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Without departing from the spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by persons skilled in the art should fall within the scope of protection defined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating diabetes, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 45 parts of Chaga, 30 parts of Pueraria root, 30 parts of Radix Trichosanthis, 30 parts of Gallus gallus domesticus, 15 parts of Scutellaria baicalensis and 15 parts of Salvia miltiorrhiza; The preparation method of the Chinese medicine composition comprises the following steps: After the Chaga mushroom pieces are dried at 55-65°C, they are crushed and micronized in an ultra-low temperature mill at -10°C to a mesh size of 1000-10000 to obtain Chaga mushroom ultra-fine powder. A mixture of kudzu root, trichosanthes root, chicken's gizzard lining, scutellaria baicalensis, and salvia miltiorrhiza is decocted with water, filtered, and concentrated into a clear paste; ethanol is added until the clear paste contains 60 vol% ethanol, stirred, allowed to stand, filtered, and concentrated into an extract to obtain a Chinese medicine extract; The Chaga superfine powder and the traditional Chinese medicine extract are mixed, dried, and powdered to obtain the traditional Chinese medicine composition; The amount of water used for decoction is 8-10 times the weight of the mixed medicinal materials, and the decoction is performed twice, each time for 1-2 hours; The conditions for drying the Chaga superfine powder and the Chinese herbal medicine extract after mixing are 40° C. and 30 minutes.

2. Use of the Chinese medicine composition according to claim 1 in the preparation of medicines for treating diabetes.

3. A drug for treating diabetes, characterized in that: The invention comprises the traditional Chinese medicine composition according to claim 1, and pharmaceutically acceptable excipients.

4. The drug according to claim 3, characterized in that The dosage form of the medicine is granule.

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