Traditional Chinese medicine composition for diabetes combined with chronic coronary syndrome, preparation method and application thereof

Abstract

This application discloses a traditional Chinese medicine composition for diabetes mellitus complicated with chronic coronary syndrome, its preparation method, and its application. The composition comprises: 2-6 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-6 parts of Poria cocos, and 1-2 parts of Amomum villosum. This composition targets the characteristics of Qi and Yin deficiency and blood stasis in type 2 diabetes mellitus complicated with chronic coronary syndrome, combining Qi-tonifying and Yin-nourishing with blood-activating and stasis-removing effects. It compensates for the current deficiencies in the comprehensive clinical treatment of diabetes mellitus complicated with chronic coronary syndrome, providing a new approach and method for the comprehensive regulation of this condition.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for diabetes mellitus complicated with chronic coronary syndrome, its preparation method and application. Background Technology

[0002] Diabetes mellitus is a major risk factor for many cardiovascular diseases. Elevated blood glucose levels caused by type 2 diabetes damage blood vessels, promoting the progression of atherosclerotic cardiovascular disease (ASCVD). Cardiovascular events resulting from endothelial damage are the leading cause of death in diabetic patients. Multiple retrospective studies of diabetic patients with cardiovascular disease both domestically and internationally have shown that intensive glycemic management should be a necessary treatment measure for patients with cardiovascular disease. As of 2021, the total number of people with diabetes worldwide was 529 million, and it is projected to reach 1.31 billion by 2050. China has over 118 million people with diabetes, accounting for approximately 22% of the global total, and about 30.1% of Chinese adults with type 2 diabetes mellitus (T2DM) also have cardiovascular disease. This means that the burden on the healthcare system for preventing and controlling diabetes, including its complications such as cardiovascular disease, will continue to increase.

[0003] The concept of chronic coronary syndrome (CCS) was introduced in the "Guidelines for the Diagnosis and Management of Chronic Coronary Syndrome" published by the European Society of Cardiology (ESC) in 2019. It is a comprehensive clinical manifestation of coronary artery disease in the stable phase. Compared with the concept of stable coronary atherosclerotic disease (SCAD), it focuses more on the control of the dynamic pathological process of patients. Patients may face different risks at different stages and need continuous monitoring and management.

[0004] The "Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndrome in China," published in 2024, updated the nomenclature and management guidelines for this disease in my country. The guidelines specifically mention that patients with coronary artery disease and diabetes have a significantly increased risk of major adverse cardiovascular events (MACE).

[0005] Compared to patients with coronary artery disease alone, those with coronary artery disease and diabetes often experience more complex and atypical symptoms. Due to the widespread presence of autonomic neuropathy, their angina is often atypical and difficult to detect. Disorders of sympathetic nerve function also increase the risk of arrhythmias in diabetic patients, with resting tachycardia being common. When a myocardial infarction occurs in diabetic patients with coronary artery disease, the infarct area is often larger and more severe than in patients with coronary artery disease alone, making them more prone to complications such as arrhythmias and cardiac rupture. Diabetic patients with coronary artery disease often have extensive coronary artery disease, frequently involving multiple vessels, with a higher incidence of left main coronary artery disease, dual-vessel, triple-vessel, and bifurcation disease. Diffuse lesions, occlusive lesions, and collateral circulation are common, with severe hemorrhage, ulceration, and calcification. The distribution of atherosclerotic plaques is wider, and the degree of luminal stenosis is greater, significantly increasing the risk of sudden death from large-area myocardial infarction. Furthermore, the hyperglycemic state and insulin resistance trigger a series of metabolic disorders, such as hypertension and dyslipidemia often present in diabetic patients, which further exacerbate vascular inflammation and endothelial changes, making the condition of diabetic patients with coronary heart disease more complex and treatment more difficult. Currently, there are no drugs specifically for diabetic patients with chronic coronary syndrome. Summary of the Invention

[0006] In order to address the above-mentioned deficiencies in this field, this application aims to provide a traditional Chinese medicine composition for diabetes mellitus complicated with chronic coronary syndrome, its preparation method and application.

[0007] According to one aspect of this application, a traditional Chinese medicine composition for diabetes mellitus complicated with chronic coronary syndrome is provided, comprising, by weight: 2-6 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-6 parts of Poria cocos, and 1-2 parts of Amomum villosum.

[0008] According to some embodiments, the traditional Chinese medicine composition includes: 3-6 parts of Codonopsis pilosula, 3-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 3-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 3-6 parts of Poria cocos, and 1-2 parts of Amomum villosum.

[0009] According to some embodiments, the traditional Chinese medicine composition includes: 4-5 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-3 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-5 parts of Poria cocos, and 1-2 parts of Amomum villosum.

[0010] On the other hand, this application also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating diabetes mellitus complicated with chronic coronary syndrome.

[0011] This application also includes a medicament comprising the above-described traditional Chinese medicine composition for diabetes mellitus complicated with chronic coronary syndrome.

[0012] According to some embodiments, the drug is taken orally.

[0013] According to some embodiments, the medicine is in the form of tablets, granules, powder, tea, or solid beverage.

[0014] According to one aspect of this application, a method for preparing a medicament for treating diabetes mellitus complicated with chronic coronary syndrome is provided, comprising:

[0015] Weigh the following ingredients by weight: Codonopsis pilosula 2-6 parts, Ophiopogon japonicus 2-4 parts, Schisandra chinensis 1-2 parts, Salvia miltiorrhiza 2-4 parts, Coptis chinensis 1-2 parts, Poria cocos 2-6 parts, Amomum villosum 1-2 parts.

[0016] Remove impurities from the raw materials, add 8-12 times the amount of water and decoct, extracting twice;

[0017] The extract was concentrated under reduced pressure and then filtered to obtain a concentrated solution.

[0018] Add excipients to the concentrate, mix well, and spray dry in a spray dryer to obtain spray-dried powder;

[0019] Add appropriate excipients to the sprayed dry powder, mix well, and then granulate.

[0020] According to some embodiments, the extract was concentrated under reduced pressure to a relative density of 1.05-1.07.

[0021] According to some embodiments, the temperature for vacuum concentration is 70-75°C.

[0022] Compared with the prior art, this application has at least the following beneficial effects:

[0023] This application provides a traditional Chinese medicine composition for diabetes mellitus complicated with chronic coronary syndrome, scientifically formulated with Codonopsis pilosula, Ophiopogon japonicus, Schisandra chinensis, Salvia miltiorrhiza, Coptis chinensis, Poria cocos, and Amomum villosum. Targeting the characteristics of Qi and Yin deficiency and blood stasis in type 2 diabetes mellitus complicated with chronic coronary syndrome, it balances tonifying Qi and nourishing Yin with promoting blood circulation and removing blood stasis, thus addressing the shortcomings of current comprehensive clinical treatments for diabetes mellitus complicated with chronic coronary syndrome, and providing a new approach and method for the comprehensive regulation of this condition. Furthermore, this composition contains few ingredients and requires small dosages, and is inexpensive. It is also safe and effective, with a consistent and mature theoretical framework, conforming to traditional Chinese medicine principles. Attached Figure Description

[0024] Figure 1 This study compares the TCM syndrome scores of two groups of patients before and after intervention in the experimental cases of this application.

[0025] Figure 2 This is a comparison of fasting blood glucose levels before and after intervention in the two groups of patients in the experimental cases of this application.

[0026] Figure 3This is a comparison of the mean SAQ scores of the two groups of patients before and after intervention in the experimental cases of this application.

[0027] Figure 4 This is a comparison of the efficacy evaluation of the two groups of patients in the experimental cases of this application. Detailed Implementation

[0028] The technical solution of this application will be clearly and completely described below with reference to the embodiments of this application. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0029] It should be particularly noted that similar substitutions and modifications made to this application are obvious to those skilled in the art, and they are all considered to be included in this application. Those skilled in the art can obviously make modifications or appropriate alterations and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this application to implement and apply the technology of this application. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments.

[0030] Unless otherwise specified, this application shall be made in accordance with conventional conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments used, whose manufacturers are not specified, are all conventional products that can be obtained commercially.

[0031] The present application will now be described in detail with reference to specific embodiments.

[0032] Example: Preparation of the traditional Chinese medicine composition of this application

[0033] Weigh the following ingredients by weight: Codonopsis pilosula 2-6 parts, Ophiopogon japonicus 2-4 parts, Schisandra chinensis 1-2 parts, Salvia miltiorrhiza 2-4 parts, Coptis chinensis 1-2 parts, Poria cocos 2-6 parts, Amomum villosum 1-2 parts.

[0034] Remove impurities from the raw materials, add 8-12 times the amount of water and decoct, extracting twice;

[0035] The extract was concentrated under reduced pressure at 70-75℃ to a relative density of 1.05-1.07, then filtered to obtain the concentrate.

[0036] Add excipients to the concentrate, mix well, and spray dry in a spray dryer to obtain spray-dried powder;

[0037] Add appropriate excipients to the sprayed dry powder, mix well, and then granulate.

[0038] Experimental Example

[0039] The granules prepared using the examples were validated through randomized, double-blind, placebo-controlled, parallel-controlled clinical trials.

[0040] 1. Enrollment Status

[0041] Patients who visited Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University, between August 2024 and February 2025 were selected as the study subjects. This study protocol was approved by the hospital's ethics committee (ethics approval number: 2024BL02-096-03). A randomized, double-blind study method was adopted. Random sequences were generated by computer software, and subjects were randomly assigned to the treatment group and the control group in a 1:1 ratio. Randomization was concealed using sequence-coded, sealed, and opaque envelopes.

[0042] 2. Inclusion criteria

[0043] All patients in the study met the diagnostic criteria for type 2 diabetes mellitus complicated with chronic coronary syndrome of the type with deficiency of both qi and yin and blood stasis.

[0044] (1) Age between 35 and 80 years old (inclusive);

[0045] (2) Patients who meet the diagnostic criteria for type 2 diabetes and chronic coronary syndrome and have symptoms of angina pectoris;

[0046] (3) Those who meet the diagnostic criteria for diabetes and chest pain in traditional Chinese medicine, and whose syndrome is diagnosed as qi and yin deficiency with blood stasis in traditional Chinese medicine;

[0047] (4) The patient did not regularly take any preparations containing traditional Chinese medicine ingredients in the month prior to enrollment;

[0048] (5) The subject or his or her legal representative voluntarily signed the informed consent form.

[0049] 3. Groups and Intervention Methods

[0050] A parallel controlled trial was conducted, with patients meeting the inclusion criteria randomly assigned to the treatment group and the control group at a 1:1 ratio. Subjects in the control group received only standard Western medicine treatment.

[0051] (1) Treatment group: In addition to routine oral Western medicine treatment, the traditional Chinese medicine composition prepared as shown in the embodiments of this application was added. It was prepared by the Department of Pharmacy of our hospital and was in the form of a compound preparation, with each bag containing 10 mL. It should be taken 0.5 hours after the Western medicine, one bag each time, twice a day, for 4 consecutive weeks.

[0052] (2) Control group: Only conventional Western medicine standard treatment was used.

[0053] (3) Both the treatment group and the control group received lifestyle control and standardized Western medicine treatment. The specific Western medicine treatment plan was formulated by the cardiologists of our hospital based on the patient's condition and with reference to the 2024 Chinese Guidelines for the Prevention and Treatment of Diabetes and the 2024 Chinese Guidelines for the Diagnosis and Management of Chronic Coronary Syndrome.

[0054] 4. Observation Indicators

[0055] (1) Main observation indicators:

[0056] ① Traditional Chinese Medicine (TCM) Syndrome Score: A TCM syndrome score scale (Appendix 1) was developed with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" (2002 edition) and "Internal Medicine of Traditional Chinese Medicine" (2021 edition). The TCM syndrome scores of patients were recorded one day before treatment and four weeks after treatment.

[0057] ② Blood glucose level: Fasting blood glucose levels were measured 1 day before treatment and 29 days after treatment.

[0058] ③ Seattle Angina Questionnaire (SAQ, Appendix 2) scores: Patients' SAQ scores were recorded 1 day before treatment and 4 weeks after treatment. The scores were evaluated from five dimensions: physical limitation (PL), angina frequency (AF), angina stability (AS), disease specificity (DS), and treatment satisfaction (TS). The average score of the five items was calculated as the overall quality of life score for chronic coronary syndrome.

[0059] (2) Secondary observation indicators:

[0060] ① Glycated hemoglobin level: Plasma HbA1c levels were measured 1 day before treatment and 29 days after treatment.

[0061] ② Blood glucose fluctuation level: Patients were fitted with a continuous glucose monitoring (CGM) system 1 week before treatment and 5 weeks after treatment. Changes in relevant parameters of CGM were observed 1 week before treatment and 1 week after treatment (calibrated with fingertip blood glucose levels). Specifically, these parameters included: the percentage of time in the target glucose range (3.9-10.0 mmol / L) (time in range, TIR), the percentage of time below the target glucose range (<3.9 mmol / L) (time below range, TBR), the percentage of time above the target glucose range (>10.0 mmol / L) (time above range, TAR), the standard deviation of blood glucose level (SD), the coefficient of variation of blood glucose (CV), the mean blood glucose level (MBG), and the glucose management indicator (GMI).

[0062] (3) Safety indicators and follow-up of adverse events

[0063] Safety parameters were measured 1 day before treatment and 4 weeks after treatment. These included routine laboratory parameters such as complete blood count, urinalysis, liver function tests (ALT, AST), and kidney function tests (Cr, UREA), as well as adverse reactions occurring in each group during treatment, such as allergies, gastrointestinal symptoms, and severe liver and kidney damage. Patients were followed up in outpatient clinics 4 weeks after medication to record their symptoms and adverse events.

[0064] Therapeutic effect evaluation:

[0065] (1) Therapeutic efficacy based on TCM syndromes: The therapeutic efficacy based on TCM syndromes was recorded for each group of patients on day 28 of treatment. The criteria for judging the therapeutic efficacy based on TCM syndromes were based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", and the specific criteria are as follows:

[0066] Significant effect: Clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%.

[0067] Effective: Clinical symptoms and signs have improved, and the syndrome score has decreased by ≥30%.

[0068] Ineffective: Clinical symptoms and signs show no significant improvement, or even worsen, and the syndrome score decreases by <30%.

[0069] (2) Diabetes efficacy: Diabetes efficacy was recorded for each group of patients on day 28 of treatment. The criteria for judging diabetes efficacy were based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", and the specific criteria are as follows:

[0070] Significant effect: Fasting blood glucose and 2-hour postprandial blood glucose decrease to the normal range, or decrease by more than 40% of the pre-treatment range. Glycated hemoglobin decreases to the normal range, or decreases by more than 30% of the pre-treatment range.

[0071] Effective: Fasting blood glucose and 2-hour postprandial blood glucose decreased by more than 20% compared to pre-treatment levels, but did not meet the criteria for marked effectiveness. Glycated hemoglobin decreased by more than 10% compared to pre-treatment levels, or did not meet the criteria for marked effectiveness.

[0072] Ineffective: Fasting blood glucose and 2-hour postprandial blood glucose did not decrease, or the decrease did not meet the effective standard. Glycated hemoglobin did not decrease, or the decrease did not meet the effective standard.

[0073] (3) Efficacy of treatment for angina symptoms: The frequency of angina attacks, duration of each attack, severity of pain, and dosage of nitroglycerin or other medications (such as quick-acting heart-saving pills) used to control acute angina attacks were recorded one day before treatment and on day 28 of treatment. The criteria for judging the efficacy of treatment for angina symptoms were based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", and the specific criteria are as follows:

[0074] Significant efficacy: After treatment, the angina symptom grade of exertional angina decreased by two grades or disappeared. Patients originally classified as Grade I or II experienced near-complete disappearance of angina (i.e., angina generally did not occur even with strenuous physical activity exceeding daily routines), and no nitroglycerin or other medications to control acute angina attacks were needed. For non-exertional angina, symptoms disappeared or nearly disappeared, with angina attacks occurring no more than twice a week, and nitroglycerin or other medications to control acute angina attacks were generally not needed.

[0075] Improvement: After treatment, the angina symptoms of exertional angina decreased by one grade, and the dosage of nitroglycerin was reduced by more than half. The angina of patients who were originally in grade A basically disappeared and nitroglycerin was no longer needed. For non-exertional angina, the frequency of angina and the dosage of nitroglycerin were reduced by more than half after treatment.

[0076] Ineffective: Symptoms and nitroglycerin dosage remain unchanged, or although reduced, they do not improve the condition.

[0077] Worsening: The frequency, intensity, and duration of pain attacks increase, or angina pectoris worsens, requiring an increase in nitroglycerin dosage.

[0078] Effectiveness = (Significant effect + Effective) / Total number of cases × 100%.

[0079] 5. Data acquisition, data management and statistical analysis

[0080] After enrollment, the researchers collected general information, TCM syndrome scores, Seattle Angina Scale (SAQ) scores, and adverse reaction data from the patients. Fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), complete blood count, urinalysis, liver function tests (ALT, AST), and kidney function tests (Cr, UREA) were measured by our hospital's laboratory. Blood glucose fluctuations were measured using a continuous glucose monitoring system (model: GX-03S), continuously monitoring blood glucose fluctuations before and one week after the intervention.

[0081] During the trial, senior physicians will regularly supervise the study to ensure strict adherence to the research protocol and accurate recording of clinical data. Researchers should objectively and truthfully record and retain all data and details of protocol implementation and modifications throughout the trial. During patient recruitment, consistency in inclusion and exclusion criteria should be maintained as much as possible.

[0082] 6. Research Results

[0083] (1) Baseline comparison of general conditions between the treatment group and the control group

[0084] A total of 60 cases were ultimately included, with 57 completing the study and 3 dropping out. In the treatment group, 28 participants completed the study and 2 dropped out, while in the control group, 29 participants completed the study and 1 dropped out. Among the dropouts, one participant in the treatment group withdrew from the study within one week of the intervention start date for personal reasons, and one patient in each group was lost to follow-up after four weeks. No participants withdrew due to adverse events. In the treatment group, there were 17 male and 11 female participants, with an age distribution of (67.36±10.37) years. 19 participants had hypertension, and 20 had hyperlipidemia. In the control group, there were 21 male and 8 female participants, with an age distribution of (64.90±10.06) years. 22 participants had hypertension, and 19 had hyperlipidemia. Baseline data comparing the general characteristics of the two groups are shown in Table 1. There were no statistically significant differences between the treatment group and the control group in terms of age, gender, type 2 diabetes mellitus (T2DM), duration of CCS history, proportion of patients with hypertension, hyperlipidemia, and concurrent treatment (P > 0.05).

[0085] Table 1 Comparison of general conditions between the two groups of patients

[0086]

[0087] Note: n This indicates the number of people in the group.

[0088] Patients meeting the inclusion criteria were randomly assigned to a treatment group and a control group. Standardized Western medicine treatment plans were developed based on the patients' conditions. For patients with stable conditions, the original treatment plan was maintained as much as possible. Baseline observation indicators measured before intervention were compared between the two groups; the results are shown in Table 2. There were no statistically significant differences in any of the observation indicators between the treatment and control groups. P Since the baseline difference between the two sets of data is greater than 0.05, the baseline difference is not significant and they are comparable.

[0089] Table 2 Comparison of observation indicators between the two groups of patients before intervention

[0090]

[0091] Note: n This indicates the number of people in the group.

[0092] As shown in Tables 1 and 2, there were no statistically significant differences between the treatment group and the control group in terms of age, sex, BMI, T2DM, duration of CCS history, proportion of hypertension and hyperlipidemia, concomitant insulin therapy, revascularization therapy, and baseline observation indicators. P Since the baseline values ​​were greater than 0.05, the baseline values ​​of the treatment group and the control group were consistent, and the two groups were comparable.

[0093] (2) Comparison of TCM syndrome scores before and after intervention in the two groups

[0094] Table 3 Comparison of TCM syndrome scores before and after intervention in the two groups of patients

[0095]

[0096] Note: △ indicates the comparison with the pre-intervention level. P <0.05, ※ indicates compared with the control group P <0.05, n This indicates the number of people in the group.

[0097] According to the results in Table 3, the comparison of TCM syndrome scores before and after intervention in the treatment group showed that the TCM syndrome scores of the treatment group improved significantly after intervention. Within-group comparisons also showed improvement. P <0.001, the difference is statistically significant; comparison of TCM syndrome scores before and after intervention in the control group. P= 0.057 > 0.05, the difference was not statistically significant; comparison between the two intervention groups. P= 0.003 < 0.05, the difference is statistically significant.

[0098] (3) Comparison of blood glucose levels before and after intervention in the two groups

[0099] Table 4 Comparison of blood glucose levels before and after intervention in the two groups of patients

[0100]

[0101] Note: △ indicates the comparison with the pre-intervention level. P <0.05, ※ indicates compared with the control group P <0.05, n This indicates the number of people in the group.

[0102] Table 4 shows that, before and after the intervention, the overall FPG level in the treatment group decreased, while the overall FPG level in the control group increased after the intervention. (Intra-group comparison of FPG levels before and after intervention in the treatment group) P =0.022 < 0.05, the difference was statistically significant; comparison within the control group before and after intervention. P= 0.027 < 0.05, the difference was statistically significant; comparison between the two intervention groups. P= 0.402 > 0.05, indicating no statistically significant difference. However, the decrease in FPG levels from baseline was greater in the treatment group (difference: 0.26 ± 1.05 mmol / L) than in the control group (difference: -0.60 ± 1.29 mmol / L). P =0.024 < 0.05, therefore the difference is still statistically significant.

[0103] (4) Comparison of SAQ scores before and after intervention in the two groups

[0104] Table 5 Comparison of SAQ scores before and after intervention in the two groups of patients

[0105]

[0106] Note: △ indicates the comparison with the pre-intervention level. P <0.05, ※ indicates compared with the control group P <0.05, n This indicates the number of people in the group.

[0107] Table 5 shows that before and after the intervention, the treatment group patients all showed increased scores in AS, AF, TS, DS, and SAQ. (Comparison of PL scores within the treatment group before and after intervention) P =0.106>0.05, comparison of PL scores within the control group before intervention. P =0.952>0.05, comparison between the two intervention groups P =0.418>0.05, no statistically significant difference. Comparison of AS scores before and after intervention within the treatment group. P =0.002 < 0.05, the difference was statistically significant; comparison of AS scores before and after intervention within the control group. P =0.248>0.05, the difference was not statistically significant; comparison between the two groups after intervention. P=0.001 < 0.05, indicating a statistically significant difference. Regarding atrial fibrillation (AF), the AF scores before and after intervention in the treatment group were compared within the same group. P =0.001 < 0.05, the difference is statistically significant; comparison of AF scores before and after intervention within the control group. P =0.589>0.05, the difference was not statistically significant; comparison between the two groups after intervention. P= 0.029 < 0.05, indicating a statistically significant difference. Regarding TS, the comparison of TS scores before and after intervention within the treatment group was statistically significant. P <0.001, the difference is statistically significant; comparison of TS scores before and after intervention within the control group. P =0.401>0.05, the difference was not statistically significant, and the two groups were compared after intervention. P <0.001, the difference is statistically significant. Regarding DS; comparison of DS scores before and after intervention within the treatment group. P =0.004 < 0.05; Comparison of DS scores within the control group before and after intervention. P =0.004 < 0.05; Intergroup comparison after intervention P <0.001, all differences were statistically significant. Regarding the mean SAQ score, the SAQ score within the treatment group was compared before and after intervention. P <0.001, the difference is statistically significant; SAQ before and after intervention in the control group were compared within the same group. P =0.984>0.05, the difference was not statistically significant; comparison between the two groups after intervention. P <0.001, the difference is statistically significant.

[0108] (5) Comparison of HbA1c levels and CGM parameters before and after intervention in the two groups

[0109] Table 6 Comparison of HbA1c levels before and after intervention in the two groups of patients

[0110]

[0111] Note: △ indicates the comparison with the pre-intervention level. P <0.05, n This indicates the number of people in the group.

[0112] Table 6 shows that the overall HbA1c levels of both groups of patients decreased before and after the intervention. (Comparison of HbA1c levels within the treatment group before and after intervention) P =0.048 < 0.05, the difference was statistically significant; comparison within the control group before and after intervention. P= 0.839 > 0.05, the difference was not statistically significant; comparison between the two intervention groups. P= 0.774 > 0.05, the difference is not statistically significant.

[0113] Table 7 Comparison of CGM parameters before and after intervention in the two groups of patients

[0114]

[0115] Note: △ indicates the comparison with the pre-intervention level. P <0.05, n This indicates the number of people in the group.

[0116] Table 7 shows the comparisons before and after intervention in the TBR treatment group. P =0.026 < 0.05, the difference was statistically significant; intra-group comparison before and after intervention in the TBR control group. P =0.313>0.05, comparison between the two intervention groups P =0.222>0.05, the difference was not statistically significant. Within-group comparison before and after intervention in the MBG treatment group. P =0.799>0.05, comparison within the control group before and after intervention. P =0.895>0.05, comparison between the two intervention groups P =0.180>0.05; Comparison within the GMI treatment group before and after intervention P =0.597>0.05, comparison within the control group before and after intervention. P =0.058>0.05, comparison between the two intervention groups P =0.063>0.05; Comparison within the TIR treatment group before and after intervention P =0.524>0.05, comparison within the control group before and after intervention. P =0.589>0.05, comparison between the two intervention groups P= 0.170 > 0.05; Comparison within the TAR treatment group before and after intervention. P =446>0.05, within-group comparison before and after intervention in the control group P =0.909>0.05, comparison between the two intervention groups P =0.067>0.05. Although the TAR data of the two groups after the intervention showed different trends, the overall difference in TAR levels before and after the intervention between the two groups was significant [treatment group 1.4 (-3.4, 9.75) control group 0.2 (-7.45, 7.95)]. P =0.443>0.05, the difference was still not statistically significant. Within-group comparison before and after intervention in the SD treatment group. P =0.227>0.05, comparison within the control group before and after intervention. P =0.864>0.05, comparison between the two intervention groups P =0.621>0.05; Comparison within the CV treatment group before and after intervention. P=0.245>0.05, comparison within the control group before and after intervention. P =0.891>0.05, comparison between the two intervention groups P =0.737>0.05, and the differences were not statistically significant.

[0117] (6) Evaluation of therapeutic effect

[0118] Table 7 Comparison of TCM syndrome efficacy between the two groups of patients

[0119]

[0120] Note: ※ indicates comparison with the control group. P <0.05, n This indicates the number of people in the group.

[0121] As shown in Table 7, after treatment, in the treatment group, 1 patient showed significant improvement in TCM syndrome differentiation, 12 patients showed improvement, and 15 patients showed no improvement, with a total effective rate of 46.43%. In the control group, 0 patients showed significant improvement, 5 patients showed improvement, and 24 patients showed no improvement, with a total effective rate of 17.24%. The comparison of the effective rates between the two groups... P =0.018 < 0.05, the difference is statistically significant.

[0122] Table 8 Comparison of treatment efficacy for diabetes in the two groups of patients

[0123]

[0124] Note: n This indicates the number of people in the group.

[0125] As shown in Table 8, in the treatment group, 3 patients with diabetes showed significant improvement, 11 showed improvement, and 14 showed no improvement, with a total effective rate of 50.00%; in the control group, 0 patients with diabetes showed significant improvement, 11 showed improvement, and 18 showed no improvement, with a total effective rate of 37.93%. The comparison of the effective rates between the two groups... P =0.359>0.05, the difference is not statistically significant.

[0126] Table 9 Comparison of treatment efficacy for angina symptoms between the two groups of patients

[0127]

[0128] Note: ※ indicates comparison with the control group. P <0.05, n This indicates the number of people in the group.

[0129] As shown in Table 9, in the treatment group, 3 patients showed significant improvement in angina symptoms, 12 showed improvement, and 13 showed no improvement, with a total effective rate of 50.00%; in the control group, 0 patients showed significant improvement in angina symptoms, 4 showed improvement, and 25 showed no improvement, with a total effective rate of 37.93%. The comparison of the effective rates between the two groups... P=0.001 < 0.05, the difference is statistically significant.

[0130] 7. Safety indicators, adverse reactions, and other situations.

[0131] During the clinical observation period, no patients in either group experienced nausea, vomiting, hematuria, hematochezia, rash, or other drug allergic reactions. No acute hypoglycemia or diabetic ketoacidosis occurred in either group during the trial. No adverse cardiovascular events such as ACS occurred in either group during the trial. No significant abnormalities were observed in blood routine tests, liver function tests, or kidney function tests before and after medication in either group.

[0132] The above description of the embodiments is only for the purpose of helping to understand the method and core ideas of this application. It should be noted that, for those skilled in the art, several improvements and modifications can be made to this application without departing from the principles of this application, and these improvements and modifications also fall within the protection scope of the claims of this application.

Claims

1. A traditional Chinese medicine composition for diabetes combined with chronic coronary syndrome, characterized in that, The composition, by weight, comprises: 2-6 parts Codonopsis pilosula, 2-4 parts Ophiopogon japonicus, 1-2 parts Schisandra chinensis, 2-4 parts Salvia miltiorrhiza, 1-2 parts Coptis chinensis, 2-6 parts Poria cocos, and 1-2 parts Amomum villosum.

2. The traditional Chinese medicine composition for diabetes combined with chronic coronary syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition is: Codonopsis pilosula 3-6 parts, Ophiopogon japonicus 3-4 parts, Schisandra chinensis 1-2 parts, Salvia miltiorrhiza 3-4 parts, Coptis chinensis 1-2 parts, Poria cocos 3-6 parts, Amomum villosum 1-2 parts.

3. The traditional Chinese medicine composition for diabetes combined with chronic coronary syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition is: Codonopsis pilosula 4-5 parts, Ophiopogon japonicus 2-4 parts, Schisandra chinensis 1-2 parts, Salvia miltiorrhiza 2-3 parts, Coptis chinensis 1-2 parts, Poria cocos 2-5 parts, Amomum villosum 1-2 parts.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating diabetes mellitus complicated with chronic coronary syndrome.

5. A medicament, characterized by comprising a compound of the formula (I) or a pharmaceutically acceptable salt thereof. A traditional Chinese medicine composition containing any one of claims 1-3 for diabetes mellitus complicated with chronic coronary syndrome.

6. The medicament according to claim 5, characterized in that, The medication is for oral administration.

7. The medicament according to claim 5, characterized in that, The drug is in the form of tablets, granules, powder, tea, or solid beverage.

8. A method for preparing a medicament for treating diabetes mellitus complicated with chronic coronary syndrome, characterized in that, include: Weigh the following ingredients by weight: Codonopsis pilosula 2-6 parts, Ophiopogon japonicus 2-4 parts, Schisandra chinensis 1-2 parts, Salvia miltiorrhiza 2-4 parts, Coptis chinensis 1-2 parts, Poria cocos 2-6 parts, Amomum villosum 1-2 parts. Remove impurities from the raw materials, add 8-12 times the amount of water and decoct, extracting twice; The extract was concentrated under reduced pressure and then filtered to obtain a concentrated solution. Add excipients to the concentrate, mix well, and spray dry in a spray dryer to obtain spray-dried powder; Add appropriate excipients to the sprayed dry powder, mix well, and then granulate.

9. The production method according to claim 8, characterized by, The extract was concentrated under reduced pressure to a relative density of 1.05-1.

07.

10. The method of claim 9, wherein, The temperature for vacuum concentration is 70-75℃.

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