A traditional Chinese medicine composition for treating type 2 diabetes and a preparation method thereof

Abstract

This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a traditional Chinese medicine composition for treating type 2 diabetes and its preparation method. The raw materials consist of Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, Lycium barbarum, Atractylodes lancea, dried ginger, mulberry leaf, and silkworm excrement, with a mass ratio of 3:6:6:3:2:3:3:3:3. This traditional Chinese medicine composition can not only improve blood glucose indicators, but also adjust the internal environment of the body and improve the patient's metabolic level by exerting the functions of invigorating qi and nourishing yin, promoting blood circulation and removing blood stasis, thereby achieving the purpose of lowering and stabilizing blood glucose. It can treat both the symptoms and the root cause of glucose and lipid metabolism disorders.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for treating type 2 diabetes and its preparation method. Background Technology

[0002] Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized primarily by elevated blood glucose levels. Formerly known as noninsulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes, it is a chronic metabolic disease that typically develops after age 35-40, accounting for over 90% of diabetes cases. Patients are characterized by hyperglycemia, relative insulin deficiency, and insulin resistance. Common symptoms include polydipsia, frequent urination, and unexplained weight loss; other symptoms may include increased appetite, fatigue, or muscle aches. Long-term complications of hyperglycemia include heart disease, stroke, and diabetic retinopathy, which can lead to blindness, kidney failure, and even amputation due to poor blood flow to the limbs. Diabetic ketoacidosis is a rare complication.

[0003] There is currently no cure for type 2 diabetes. Western medicine often uses single-target drugs for treatment, such as oral medications like metformin, glipizide, repaglinide, acarbose, pioglitazone, and saxagliptin, or injectable medications like liraglutide, insulin, and their analogues for symptomatic treatment. While these can control the condition in the short term, long-term use can easily lead to drug dependence, toxic side effects, and the risk of hypoglycemia.

[0004] Traditional Chinese medicine (TCM) is characterized by its holistic approach, multi-level approach, and multi-target approach, offering unique advantages in preventing disease before it occurs, reducing toxicity and enhancing efficacy, and delaying complications. Therefore, developing a TCM composition for the treatment of type 2 diabetes is of profound significance. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for treating type 2 diabetes and its preparation method.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A traditional Chinese medicine composition for treating type 2 diabetes, the raw materials of which are Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, wolfberry, Atractylodes lancea, dried ginger, mulberry leaf and silkworm excrement.

[0008] The mass ratio of Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, wolfberry, Atractylodes lancea, dried ginger, mulberry leaf and silkworm excrement is 3:6:6:3:2:3:3:3:3.

[0009] Furthermore, the ingredients consist of 15g of Coptis chinensis (principal ingredient), 30g of hawthorn (assistant ingredient), 30g of Polygonatum sibiricum (assistant ingredient), 15g of Salvia miltiorrhiza (assistant ingredient), 10g of Lycium barbarum (assistant ingredient), 15g of Atractylodes lancea (adjuvant ingredient), 15g of dried ginger (adjuvant ingredient), 15g of mulberry leaf (adjuvant ingredient), and 15g of silkworm excrement (adjuvant ingredient).

[0010] Among them, Coptis chinensis clears heat and dries dampness, drains fire and detoxifies, and can clear away heat and toxins. Modern pharmacological studies have shown that Coptis chinensis can lower blood sugar and can be used to relieve diabetic complications such as gastrointestinal dysfunction and insomnia. Hawthorn promotes qi circulation, disperses blood stasis, eliminates turbidity, lowers lipids and blood sugar; Polygonatum sibiricum replenishes qi and nourishes yin, strengthens the spleen and tonifies the earth element; Salvia miltiorrhiza clears heat and cools blood, and promotes blood circulation; Lycium barbarum nourishes the liver and kidneys and can treat internal heat and thirst; Atractylodes lancea is pungent, bitter and dry, strengthens the spleen and eliminates dampness; dried ginger dries dampness and resolves phlegm, warms the interior and dispels cold; mulberry leaf clears the lungs and moistens dryness; silkworm excrement dispels wind and dampness, harmonizes the stomach and eliminates turbidity. This formula mainly focuses on clearing heat and nourishing yin, replenishing qi and generating fluids, taking into account both tonification and purgation, with orderly ascending and descending, and appropriate cold and warm properties. It is consistent with the pathogenesis of yin deficiency and dryness-heat and yin fluid damage in diabetes, and can effectively lower blood sugar, providing new ideas and methods for the prevention and treatment of type 2 diabetes by traditional Chinese medicine.

[0011] The preparation method of the traditional Chinese medicine composition for treating type 2 diabetes according to the present invention is as follows: Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, Lycium barbarum, Atractylodes lancea, dried ginger, mulberry leaf, and silkworm excrement are mixed in a fixed ratio of 3:6:6:3:2:3:3:3: then dissolved in water equal to 8 times the total amount of the herbs and soaked for 30 minutes. The mixture is then heated under reflux for 40 minutes and filtered to extract the first decoction. Next, 6 times the total amount of the herbs are added to the remaining herbs, heated under reflux for 30 minutes, and filtered to extract the second decoction. This second decoction is then mixed with the first filtered decoction. Finally, the solution is concentrated using a rotary evaporator at 50°C to obtain the extract.

[0012] The extract contains 1 g / mL of crude drug.

[0013] Preliminary clinical applications have shown that the traditional Chinese medicine composition of this invention can regulate the body's glucose metabolism, improve patients' blood glucose levels, and has significant therapeutic effects. Moreover, no toxic side effects were observed after patients took the medicine, and it has been widely used in clinical practice.

[0014] Compared with the prior art, the beneficial effects of the present invention are:

[0015] The traditional Chinese medicine composition of the present invention is a traditional Chinese medicine preparation for treating type 2 diabetes. From the perspective of pharmacological mechanism, the traditional Chinese medicine composition can not only improve blood glucose indicators, but also adjust the internal environment of the body and improve the patient's metabolic level by exerting the functions of invigorating qi and nourishing yin, promoting blood circulation and removing blood stasis, so as to achieve the purpose of lowering and stabilizing blood glucose. It can treat both the symptoms and the root cause of glucose and lipid metabolism disorders.

[0016] Compared to most Western medicines with adverse reactions, this traditional Chinese medicine composition has fewer toxic side effects. It nourishes the lungs, spleen, and kidneys to achieve the purpose of nourishing yin and clearing heat, thus improving the symptoms of type 2 diabetes patients as a whole, slowing disease progression, and improving their quality of life. Furthermore, with the increasing number of research methods and techniques in traditional Chinese medicine and the deepening understanding of its mechanisms of action, this formula has been proven to effectively lower blood sugar. This formula possesses the characteristics and advantages of treating both the symptoms and the root cause in traditional Chinese medicine, providing an effective approach for the prevention and treatment of type 2 diabetes.

[0017] With the continuous development of traditional Chinese medicine, Chinese herbal medicines, relying on their flexible composition, low price, high safety, and few side effects, are being accepted by more and more people and have broad development prospects. The widespread promotion and application of this formula in clinical practice has good social and economic benefits and promotes the healthy and balanced development of my country's medical industry. Attached Figure Description

[0018] Figure 1 The changes in biochemical levels of rats in each group after treatment are shown in Figure 1. (A) Changes in FBG, 2hPG, and HbA1c before and after treatment in each group of rats. Compared with the model group, *P<0.01; compared within the same group before and after treatment, ▲P<0.01. (B) Pathological changes in pancreatic tissue of rats in different groups after treatment (magnified 200 times).

[0019] Figure 2 The results of LPJZF treatment for T2DM are shown in the following: (A) Screening of differentially expressed proteins between the H-JTF group and the model group; (B) KEGG pathway enrichment analysis, with small P-values ​​in red and large P-values ​​in green, and the size of the dots representing the number of proteins. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] Example

[0022] A traditional Chinese medicine composition for treating type 2 diabetes, comprising the following ingredients: 15g Coptis chinensis (principal ingredient), 30g Crataegus pinnatifida (assistant ingredient), 30g Polygonatum sibiricum (assistant ingredient), 15g Salvia miltiorrhiza (assistant ingredient), 10g Lycium barbarum (assistant ingredient), 15g Atractylodes lancea (adjuvant ingredient), 15g Zingiber officinale (adjuvant ingredient), 15g Morus alba (adjuvant ingredient), and 15g Bombyx mori excrement (adjuvant ingredient).

[0023] I. Animal Experiments

[0024] 1. Animal experimental materials and methods

[0025] 1.1 Drug Preparation

[0026] The medicinal materials in the traditional Chinese medicine composition (JTF) of this embodiment were purchased from the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, Lycium barbarum, Atractylodes lancea, dried ginger, mulberry leaf, and silkworm excrement were mixed in a fixed ratio of 3:6:6:3:2:3:3:3, dissolved in 8 times the total amount of water, and soaked for 30 minutes. The mixture was then heated under reflux for 40 minutes, and the first extract was obtained by filtration. Then, 6 times the total amount of water was added to the remaining herbs, and the mixture was heated under reflux for 30 minutes, filtered, and the second extract was obtained. This second extract was then mixed with the first extract. Finally, the solution was concentrated using a rotary evaporator at 50°C to obtain the JTF extract (containing 1 g / ml of the drug).

[0027] 1.2 Establishment of the T2DM rat model

[0028] This experiment was approved by the Animal Ethics Committee of Shandong University of Traditional Chinese Medicine, license number: SDUTCM20220307003. Male Wistar rats weighing 200±20g (Vitamin B.A. Laboratory Animal Technology Co., Ltd., Beijing, China; certificate number: SCXK2020-0005) were selected for the experiment. The rats were housed under sterile conditions for one week, with normal diet and free access to water. The room temperature was set at 24℃, the humidity at 50%, and a 12-12h light-dark cycle. The rats were then randomly divided into a control group (n=10) and a T2DM model group. The control group was fed a normal diet, while the T2DM model group was given a high-fat, high-sugar diet (67% maintenance diet, 20% sucrose, 10% lard, 2.5% cholesterol, and 0.5% sodium cholate). Eight weeks after dietary intervention, T2DM model rats were injected intraperitoneally with 40 mg / kg streptozotocin. Five days later, the rats were fasted for 12 hours, and blood was collected from the tail vein. Blood glucose levels were measured using a kit, and a blood glucose level >11 mmol / L was considered a successful model.

[0029] 1.3 Treatment of T2DM rats

[0030] T2DM rats that successfully developed the model were randomly divided into a model group, a high-dose JTF (H-JTF) group, and a low-dose JTF (L-JTF) group, with 10 rats in each group. The control group was fed a normal diet, while the model group and the high- and low-dose JTF groups were fed a high-fat, high-sugar diet. Simultaneously, the H-JTF group rats were administered 6 g / kg of JTF by gavage daily, the L-JTF group rats were administered 3 g / kg of L-JTF by gavage, and the control and model groups rats were administered 0.5 mL / 100 g of physiological saline by gavage. This treatment continued for four weeks.

[0031] 1.4 Blood glucose testing

[0032] Four weeks after treatment, blood was extracted from the carotid artery of rats, and serum was separated by centrifugation at 3500 rpm for 15 min. Fasting blood glucose (FBG), 2-hour postprandial blood glucose (2hPG), and glycosylated hemoglobin A1c (HbA1c) levels were then measured using a kit.

[0033] 1.5 Hematoxylin and eosin (HE) staining

[0034] Pancreatic tissue was fixed with 4% paraformaldehyde, then embedded in paraffin, and cut into 5 μm thick sections. The sections were then dehydrated with ethanol and xylene, washed with 5% hematoxylin solution, and the cell nuclei were stained for 10 min. Afterward, they were incubated in HCl-ethanol for 30 s and stained with eosin solution for 2 min. Finally, the sections were stained with hematoxylin and eosin (HE) and examined morphologically using a fluorescence microscope.

[0035] 1.6 Proteomics Research

[0036] Proteomics studies were conducted using control, model, and H-JTF groups. First, a fourfold lysis buffer containing 1% sodium deoxycholate and 1% protease inhibitor was added to powdered pancreatic tissue. The mixture was sonicated using an ultrasonic processor, centrifuged at 12000 rpm for 10 min, and the supernatant was used to determine protein concentration using a BCA protein quantification kit. Subsequently, the protein solution was reduced with dithiothreitol at 56°C for 30 min, and iodoacetamide was added to a final concentration of 11 mM. After incubation at room temperature for 15 min, tetraethylammonium bromide was added to dilute urea. Finally, trypsin was added at a 1:50 trypsin-to-protein mass ratio in the first 12-hour digestion, and at a 1:100 trypsin-to-protein mass ratio in the second 4-hour digestion. The peptides were then desalted using a C18 solid-phase extraction column.

[0037] For liquid chromatography-mass spectrometry (LC-MS), the peptides were dissolved in mobile phase A and separated using an EASY-nLC1200 ultra-high performance liquid chromatography (UHPLC) system. LC conditions: Mobile phase A was an aqueous solution containing 0.1% formic acid and 2% acetonitrile; mobile phase B was an aqueous solution containing 0.1% formic acid and 90% acetonitrile; the flow rate was 500 nL / min. LC separation gradient conditions: 0–68 min, 6–23% B; 68–82 min, 23–32% B; 82–86 min, 32–80% B; 86–90 min, 80% B. After separation by the UHPLC system, the peptides were analyzed using Orbitrap Exploris. TM 480 m / z mass spectrometry was used for analysis. Peptide precursor ions and secondary fragments were analyzed at an ion source voltage of 2.3 kV. The primary mass spectrometry scan range was 400–1200 m / z with a resolution of 60,000 m / z; the secondary mass spectrometry scan range had a fixed starting point of 110 m / z and a resolution of 15,000 m / z. The dynamic exclusion time for mass spectrometry scans was 20 s. Finally, the identified differentially expressed proteins were analyzed based on GO functional enrichment and KEGG pathway enrichment.

[0038] 1.7 Statistical Analysis

[0039] Statistical analysis was performed using SPSS 22.0 software. Data are expressed as mean ± standard deviation (SD). One-way ANOVA was used for comparisons among multiple groups, and t-tests were used for pairwise comparisons. P < 0.05 was considered statistically significant.

[0040] 2. Results

[0041] 2.1 Biochemical test results

[0042] like Figure 1 As shown in Figure A, the levels of FBG, 2hPG, and HbA1c in the H-JTF group rats were significantly lower than those in the model group (P<0.01), and the levels of FBG and HbA1c in the L-JTF group rats were also lower than those in the model group (P<0.01). Figure 1 As shown in Figure B, HE staining results showed that the islets of Langerhans in the control group rats were oval with clear boundaries and abundant β cells; the islets of Langerhans in the model group rats were irregular in shape and had fewer β cells than other groups; these pathological changes were significantly improved in the H-JTF group.

[0043] 2.2 Proteomics Results

[0044] The model group and the H-JTF group identified a total of 903 differentially expressed proteins, of which 360 were downregulated and 543 were upregulated. Figure 2A). KEGG pathway enrichment analysis showed significant differences in the PI3K-Akt signaling pathway, NF-κB signaling pathway, MAPK signaling pathway, FoxO signaling pathway, and phospholipase D signaling pathway between the model group and the H-JTF group. Figure 2 B).

[0045] KEGG pathway enrichment analysis revealed that the NF-κB, MAPK, PI3K-Akt, and FoxO signaling pathways were key pathways for JTF intervention identified in proteomics analysis. Studies have shown that NF-κB is closely associated with inflammation, apoptosis, and oxidative stress, making it an important target for intervention in diabetes and its complications. Activation of the NF-κB signaling pathway can effectively improve insulin resistance, regulate glucose metabolism disorders, and thus intervene in the treatment of T2DM. The MAPK signaling pathway plays a crucial role in the progression of diabetes. p38 MAPK in this pathway participates in the production of fibronectin and type IV collagen by regulating the expression of TGF-β1 and glucose transporters, thereby affecting the pathological damage and renal function deterioration in diabetes. The PI3K / Akt signaling pathway is involved in cell proliferation, differentiation, apoptosis, and glucose transport, and is closely related to insulin resistance, making it significant for the treatment of T2DM. Simultaneously, the PI3K / Akt signaling pathway can act on the FoxO signaling pathway. The FoxO signaling pathway mediates glucose transport into cells, inhibits hepatic glycogen synthesis, reduces gluconeogenesis, and increases glucose uptake, playing a crucial role in improving insulin resistance. Therefore, JTF may exert its hypoglycemic effect by multidirectionally regulating the MAPK, PI3K / Akt, FoxO, and NF-κB signaling pathways, thereby effectively treating diabetes and its complications.

[0046] 3. Results

[0047] This experiment supports the advantages of the herbal composition (JTF) of the present invention in treating T2DM through multiple targets and pathways, thus proving that it is an effective drug for treating T2DM.

[0048] II. Clinical Application

[0049] (1) Case source: Eighty patients with type 2 diabetes who met the diagnostic criteria and visited the outpatient clinics of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine and Shandong Xinzhonglu Hospital from January 2021 to January 2022 were selected as the study subjects.

[0050] (2) Diagnostic criteria

[0051] ① Western medicine diagnostic criteria

[0052] Diagnostic criteria for diabetes mellitus: The diagnostic criteria for diabetes mellitus in the 2020 edition of the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China" are adopted. As shown in Table 1.

[0053] Table 1 Diagnostic criteria for diabetes mellitus

[0054]

[0055] Note: Fasting refers to not consuming any calories for at least 8 hours.

[0056] ② Traditional Chinese Medicine Diagnosis Standards

[0057] The diagnostic criteria for spleen deficiency with dampness are as follows: Primary symptoms: poor appetite, abdominal distension, heaviness in the body, fatigue, and dry mouth without thirst. Secondary symptoms: chest tightness, shortness of breath, nausea and vomiting, abdominal distension and fullness. Tongue and pulse: pale and swollen tongue with a white, moist or greasy coating; soft and slow or wiry and slippery pulse. If at least two primary symptoms and at least two secondary symptoms are met, the diagnosis can be confirmed by referring to the tongue and pulse.

[0058] (3) Case inclusion criteria

[0059] (1) Those who meet the diagnostic criteria for type 2 diabetes and whose TCM syndrome differentiation is spleen deficiency and dampness syndrome;

[0060] (2) The patient's age is between 18 and 70 years old;

[0061] (3) Those who have good compliance and are able to receive diabetes health education as required, eat regularly, and exercise appropriately;

[0062] (4) Exclusion criteria

[0063] 1) Individuals who have experienced or currently have acute diabetic complications within the past half month

[0064] 2) Those whose primary symptom is diabetes complications;

[0065] 3) Those with primary or secondary severe acute illnesses in other tissues or organs of the body;

[0066] 4) Patients who are pregnant or breastfeeding;

[0067] 5) Individuals who are allergic to or have any contraindications to the drugs used in this study;

[0068] 6) Those who cannot cooperate (referring to those who do not cooperate with diet and exercise control or cannot take medication as prescribed, thus affecting the efficacy).

[0069] (5) Test plan

[0070] ① Case grouping

[0071] The 80 patients who met the inclusion criteria were randomly divided into an observation group and a control group, with 40 patients in each group.

[0072] ② Treatment methods

[0073] Basic treatment: Both groups received diabetes health education and guidance regarding diet and exercise. Drug treatment: Control group: Metformin tablets (China Resources Shuanghe Pharmaceutical Co., Ltd., 0.5g / tablet), 1 tablet / time, taken orally half an hour before breakfast and dinner; Observation group: In addition to the treatment given to the control group, the group received the traditional Chinese medicine formula from Example 1, decocted in water and taken orally. The decoction was prepared by the pharmacy of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, one dose daily, divided into two administrations, morning and evening. The treatment course for both groups was 4 weeks.

[0074] ③ Observation indicators

[0075] Therapeutic indicators: (1) Blood glucose indicators: fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2hPG), glycated hemoglobin (HbA1c); (2) Blood lipid indicators: total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL); (3) Traditional Chinese medicine syndrome score.

[0076] Safety indicators: vital signs (body temperature, pulse, respiration, blood pressure) before and after treatment, complete blood count, urinalysis, stool routine test, liver and kidney function tests, routine electrocardiogram; adverse reaction records.

[0077] ④Efficacy evaluation

[0078] 1) The evaluation of efficacy in Traditional Chinese Medicine is based on the standards recorded in the "Guiding Principles for Clinical Practice of New Chinese Medicine Drugs".

[0079] Clinical cure: The clinical symptoms in traditional Chinese medicine have basically disappeared, and the syndrome score has decreased by ≥95%.

[0080] Significant effect: Most of the clinical symptoms in traditional Chinese medicine disappear or weaken, and the syndrome score decreases by ≥70%.

[0081] Effective: Clinical symptoms in Traditional Chinese Medicine (TCM) are significantly reduced, and the syndrome score is reduced by ≥30%.

[0082] Ineffective: No significant improvement in clinical symptoms according to Traditional Chinese Medicine (TCM), and a decrease in syndrome score of <30%.

[0083] 2) Western medicine efficacy evaluation criteria

[0084] Significant effect: Fasting blood glucose and 2-hour postprandial blood glucose decreased to the normal range or decreased by more than 40% of the pre-treatment level, and glycated hemoglobin decreased to the normal range or decreased by more than 30% of the pre-treatment level.

[0085] Effective: Fasting blood glucose and 2-hour postprandial blood glucose decreased by more than 20% compared to before treatment, and glycated hemoglobin decreased by more than 10% compared to before treatment, but did not meet the criteria for significant effect.

[0086] Ineffective: Fasting blood glucose, 2-hour postprandial blood glucose, and glycated hemoglobin do not decrease or decrease to an ineffective standard.

[0087] ⑤ Statistical methods

[0088] SPSS 23.0 software was used for statistical analysis. Quantitative data were expressed as mean ± standard deviation (Mean ± SD). All collected data were first tested for normality. If normality and homogeneity of variance were met, paired t-tests were used for comparisons within groups before and after treatment, and independent samples t-tests were used for comparisons between groups. If normality and homogeneity of variance were not met, rank-sum tests were used. Chi-square tests were used for categorical data. Rank-sum tests were used for ordinal data. P < 0.05 was considered statistically significant.

[0089] (6) Results and Analysis

[0090] Gender analysis of the two groups: This study included 80 patients who met the criteria. The observation group consisted of 20 males and 20 females, while the control group consisted of 25 males and 15 females. P > 0.05, indicating no statistically significant difference in gender between the two groups, and therefore no impact on the experimental results. The age distribution of the patients in both groups was 37-65 years in the observation group and 36-66 years in the control group. Normality tests were performed on the ages of both groups, with P > 0.05 in both groups. Both groups conformed to a normal distribution, and t-tests confirmed no statistically significant difference in age distribution between the observation and control groups (P > 0.05).

[0091] Table 2 Comparison of blood glucose levels between the two groups of patients (Mean ± SD)

[0092]

[0093] Note: Within-group comparison: *P<0.01; Between-group comparison: ▲P<0.05.

[0094] Table 3 Comparison of blood lipid levels between the two groups of patients (Mean±SD)

[0095]

[0096] Note: Within-group comparison: *P<0.01; Between-group comparison: ▲P<0.05.

[0097] Table 4. Statistical analysis of the efficacy of the two groups after treatment.

[0098]

[0099] Safety analysis and adverse reaction records:

[0100] No significant abnormalities were observed in any safety indicators before and after treatment, and no serious adverse reactions occurred during this study.

[0101] (7) Conclusion

[0102] Based on dietary control and appropriate exercise therapy, the traditional Chinese medicine composition of this invention can effectively reduce blood glucose and blood lipid levels in patients with type 2 diabetes and improve glucose and lipid metabolism.

[0103] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating type 2 diabetes, characterized in that: The raw materials are made from Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, wolfberry, Atractylodes lancea, dried ginger, mulberry leaves and silkworm excrement. The mass ratio of Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, wolfberry, Atractylodes lancea, dried ginger, mulberry leaves and silkworm excrement is 3:6:6:3:2:3:3:3:

3.

2. The traditional Chinese medicine composition for treating type 2 diabetes according to claim 1, characterized in that: The ingredients are 15g of Coptis chinensis, 30g of hawthorn, 30g of Polygonatum sibiricum, 15g of Salvia miltiorrhiza, 10g of Lycium barbarum, 15g of Atractylodes lancea, 15g of dried ginger, 15g of mulberry leaves, and 15g of silkworm excrement.

3. The method for preparing the traditional Chinese medicine composition for treating type 2 diabetes as described in claim 1 or 2, characterized in that: Take Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, wolfberry, Atractylodes lancea, dried ginger, mulberry leaf and silkworm excrement and mix them in a fixed ratio. Then dissolve them in water and soak them. Then heat to reflux, extract and filter the solution, and then concentrate to obtain the extract.

4. The method for preparing the traditional Chinese medicine composition for treating type 2 diabetes according to claim 3, characterized in that: Take Coptis chinensis, hawthorn, Polygonatum sibiricum, Salvia miltiorrhiza, Lycium barbarum, Atractylodes lancea, dried ginger, mulberry leaf, and silkworm excrement and mix them in a fixed ratio of 3:6:6:3:2:3:3:3:

3. Then dissolve them in water with 8 times the total amount of herbs and soak for 30 minutes. Then heat and reflux for 40 minutes and filter to extract the first decoction. Then add water with 6 times the total amount of herbs to the remaining herbs, heat and reflux for 30 minutes, filter to extract the second decoction, and mix it with the first filtration decoction. Finally, concentrate the solution at 50°C using a rotary evaporator to obtain the extract.

5. The method for preparing the traditional Chinese medicine composition for treating type 2 diabetes according to claim 4, characterized in that: The extract contains 1 g / mL of crude drug.

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