A medicine for treating coronary atherosclerotic ischemic heart disease

Abstract

The scheme discloses a drug for treating coronary atherosclerotic ischemic heart disease in the field of cardiovascular disease related drugs and application, and comprises Faban 5-10g, Zhuyu 5-10g, Zhishi 5-10g, Chenpi 10-15g, Fuling 5-10g, Shengjiang 5-10g, Gancao 5-10g, Danshen 10-15g, Tuobiechong 5-10g, Huanglian 3-5g and Guizhi 5-10g. The curative effects of the drugs in the compound prescription produce a synergistic effect, can effectively prevent and treat the recurrence of coronary atherosclerotic ischemic heart disease, and especially have a good treatment effect on coronary heart disease with phlegm and blood stasis.

Description

Technical Field

[0001] This invention belongs to the field of cardiovascular disease-related drugs and applications, and specifically relates to a drug for treating coronary atherosclerotic ischemic heart disease. Background Technology

[0002] Coronary atherosclerotic heart disease, commonly known as coronary artery disease, is a type of ischemic heart disease. It refers to a condition caused by narrowing or blockage of the coronary arteries, leading to myocardial ischemia, hypoxia, and even necrosis. As plaque accumulates, the narrowing of the lumen prevents blood from flowing smoothly, resulting in chest pain or discomfort known as angina. In severe cases, it can lead to heart failure and arrhythmias. Other possible symptoms include palpitations, shortness of breath, and dizziness.

[0003] Its occurrence is closely related to risk factors such as hypertension, diabetes, and hyperlipidemia. Therefore, lowering blood pressure, controlling blood sugar, and regulating lipids are routine parts of Western medicine treatment for IHD. However, Western medicine treatment for IHD still has shortcomings such as limited target sites, resulting in poor overall treatment efficacy. In addition, most clinically used drugs are classified as adjunctive therapy, focusing on delaying the progression of coronary atherosclerotic ischemic heart disease. For example, the main measures currently used in the clinical treatment of coronary atherosclerotic ischemic heart disease are still the application of lipid-lowering drugs, antiplatelet drugs, and cardiovascular secondary prevention drugs. However, Western medicine treatment has the limitation of single-target therapy and significant side effects. For example, studies on a large number of patients have shown that patients receiving statin therapy have not seen a significant improvement in the risk of death from cardiovascular events. At the same time, long-term and high-dose use of Western medicine treatment can lead to side effects such as liver and kidney damage, rhabdomyolysis, and even increase the risk of tumors. Antiplatelet drugs and anticoagulants are only used for the treatment of clinical emergencies and are not suitable for chronic treatment and prevention. Therefore, there is an urgent need for effective treatment strategies and multi-target drugs to improve treatment efficiency. Summary of the Invention

[0004] The present invention aims to provide a drug with good efficacy for coronary atherosclerotic ischemic heart disease, in order to solve the problems of single drug treatment target and serious side effects such as liver and kidney damage when using Western medicine in the prior art.

[0005] One of the drugs in this formulation for treating coronary atherosclerotic ischemic heart disease includes the active pharmaceutical ingredient within the following weight range:

[0006] Pinellia ternata 5-10g, bamboo shavings 5-10g, immature bitter orange 5-10g, dried tangerine peel 10-15g, Poria cocos 5-10g, fresh ginger 5-10g, licorice root 5-10g, salvia miltiorrhiza 10-15g, ground beetle 5-10g, Coptis chinensis 3-5g, cinnamon twig 5-10g.

[0007] Furthermore, the dosage of each raw material in the drug is as follows: Pinellia ternata 10g, Bambusa textilis 10g, Citrus aurantium 10g, Citrus reticulata 15g, Poria cocos 7.5g, Zingiber officinale 5g, Glycyrrhiza uralensis 5g, Salvia miltiorrhiza 15g, Eupolyphaga sinensis 10g, Coptis chinensis 3g, Cinnamomum cassia 5g.

[0008] IHD falls under the category of "chest pain" in Traditional Chinese Medicine (TCM). With advancements in pharmacological research, active ingredients from TCM are gaining prominence in the prevention and treatment of cardiovascular diseases. Therefore, finding safer and more effective treatments for IHD from TCM is of great significance and urgent need.

[0009] This prescription is based on the traditional decoction "Wen Dan Tang" with the addition of four herbs: Danshen (Salvia miltiorrhiza), Tubiechong (Eupolyphaga sinensis), Huanglian (Coptis chinensis), and Guizhi (Cinnamomum cassia). Wen Dan Tang was first recorded in *Qian Jin Yao Fang*, *Wai Tai Mi Yao*, and *Bei Ji Qian Jin Yao Fang*, Volume 12, Gallbladder and Internal Organs, Chapter 2, Gallbladder Deficiency: "For treating insomnia and restlessness after a serious illness, which is due to cold in the gallbladder, the Wen Dan Tang prescription is appropriate: Pinellia ternata, Bambusa textilis, and Citrus aurantium, 2 liang each; Citrus reticulata peel, 3 liang; fresh ginger, 4 liang; and licorice root, 1 liang." This demonstrates its excellent therapeutic effect on fatigue and restlessness after a serious illness.

[0010] The revised Wendan Decoction from *Sanyinji Yibingzheng* has been passed down to this day. *Sanyinji Yibingzheng Fanglun*, Volume 9, "Treats insomnia and restlessness after a serious illness, caused by cold in the gallbladder; this medicine is the main treatment. It also treats palpitations. Pinellia (washed seven times), bamboo shavings, immature bitter orange (stir-fried with wheat bran, pith removed, 2 liang each), licorice (1 liang, roasted), poria (1.5 liang). Grind into powder. Take 4 qian each time, decoct with 1.5 cups of water, 5 slices of ginger, and 1 jujube until reduced to 70%, remove the dregs, and take before meals." *Sanyinji Yibingzheng Fanglun*, Volume 10, "Treats weakness and timidity of the heart and gallbladder, easily startled by events, or having ominous dreams or being bewildered by strange phenomena, leading to palpitations and anxiety, qi stagnation and saliva production, saliva and qi stagnation, resulting in various symptoms such as shortness of breath, palpitations, fatigue, spontaneous sweating, edema of the limbs, loss of appetite, heart palpitations, and restlessness. This shows that "San Yin Ji Yi Bing Zheng" began to describe related cardiovascular symptoms in detail, which can be seen in various diseases such as cardiovascular neurosis, coronary heart disease, and heart failure with edema in modern times.

[0011] Even though traditional medical books record the above theories, they have not yet disclosed what traditional prescriptions are based on, such as how to improve the traditional prescription Wendan Decoction to achieve the therapeutic effect on coronary atherosclerotic ischemic heart disease.

[0012] Atherosclerosis of the coronary arteries leads to narrowing or blockage of the coronary arteries, resulting in myocardial hypoxia and ischemia, causing various cardiac symptoms such as chest tightness and angina. With the continuous improvement of people's living standards and changes in dietary structure, the incidence of this disease is gradually increasing, seriously threatening patients' lives and quality of life. Based on various aspects of traditional Chinese medicine theory, such as Ye Tianshi's concept of "initial illness with damp-heat in the meridians, and prolonged illness with blood damage entering the collaterals," and combined with clinical diagnostic experience and data mining analysis of medication patterns in clinical prescriptions, the inventors have innovated the traditional Chinese medicine compound of this invention. Specifically, the data mining analysis of medication patterns in prescriptions is based on prescriptions for coronary atherosclerotic ischemic heart disease from the inventors' workplace, analyzing data from multiple perspectives, including drug efficacy classification, drug meridian tropism statistical analysis, statistical analysis of the four properties and five flavors of drugs, statistical analysis of the frequency of use of different drugs, and drug cluster analysis.

[0013] In the drug combination for treating coronary atherosclerotic ischemic heart disease of this invention, the efficacy of each drug is synergistic, effectively preventing and treating the recurrence of coronary atherosclerotic ischemic heart disease, especially showing good therapeutic effects in coronary heart disease with phlegm and blood stasis. This compound is made entirely from traditional Chinese medicine raw materials, has no toxic side effects, and can replace the limitations of current single-target Western medicine treatments for improving coronary atherosclerotic ischemic heart disease. Through the multi-component, multi-pathway, and multi-target approach of traditional Chinese medicine, it provides holistic and synergistic prevention and treatment of the occurrence and development of the disease. In addition, it effectively avoids the side effects of many drugs such as statins.

[0014] In the drug combination of this invention, Pinellia ternata is pungent and warm, dries dampness and resolves phlegm, harmonizes the stomach and stops vomiting, and Salvia miltiorrhiza breaks up blood stasis in the pericardium, regulates menstruation and relieves irritability, calms the mind and stabilizes the will. Together they are the principal drugs.

[0015] I use bamboo shavings, which are sweet and slightly cold, to clear heat, resolve phlegm, relieve irritability, and stop vomiting. Ground beetle breaks up accumulations, removes blood stasis, and unblocks the meridians. Together, they remove phlegm and blood stasis in the qi level, restoring the function of qi transformation. Pinellia and bamboo shavings, one warm and one cool, resolve phlegm, harmonize the stomach, stop vomiting, and relieve irritability. Salvia miltiorrhiza and ground beetle nourish yin and open the meridians, helping to expel pathogens from the blood vessels. Tangerine peel is bitter, pungent, and warm, regulating qi, promoting circulation, drying dampness, and resolving phlegm. Immature bitter orange is bitter, pungent, and slightly cold, lowering qi, guiding stagnation, and eliminating phlegm and lumps. The combination of tangerine peel and immature bitter orange, one warm and one cool, enhances the qi-regulating and phlegm-resolving effects.

[0016] Poria cocos is added to strengthen the spleen and eliminate dampness, thus preventing the generation of phlegm; Cinnamomum cassia unblocks the qi channels, Coptis chinensis clears blood stasis and heat, regulates the body's excessive heart fire, relieving restlessness, insomnia, and palpitations, and together with Pinellia ternata, works to open up the qi and descend the qi in the three jiaos to restore the qi transformation; Ginger harmonizes the spleen and stomach, and also counteracts the toxicity of Pinellia ternata. Licorice is used as the guiding herb to harmonize all the herbs.

[0017] The various drugs of this invention are weighed and combined according to their weights, and then boiled with water to obtain a decoction, which is called "Shuxin Wendan Decoction" in this invention. It does not require special dosage forms or complicated extraction methods, making it very convenient to take the medicine. Attached Figure Description

[0018] Figure 1 : Schematic diagram of HE pathological staining of the hearts of mice in each group in this invention;

[0019] Figure 2 Echocardiograms of the hearts of mice in each group;

[0020] Figure 3 EF and FS values ​​of mice in each group; **P<0.01 vs blank; ##P<0.01 vs model; $P<0.05 vs Wendan Decoction;

[0021] Figure 4 MIRI mouse electrocardiogram;

[0022] Figure 5 Serum myocardial enzyme levels in mice of each group; **P<0.01 vs blank; ##P<0.01 vs model; $P<0.05 vs Wendan Decoction;

[0023] Figure 6 Serum lipid levels in rats of each group were measured; **P<0.01 vs blank; ##P<0.01 vs model; $P<0.05 vs Wendan Decoction;

[0024] Figure 7 AI assessment of arteriosclerosis index in rats of each group; **P<0.01 vs blank; ##P<0.01 vs model; $$P<0.01 vs Wendan Decoction;

[0025] Figure 8 Serum oxidative stress levels in rats of each group were measured; **P<0.01 vs blank; ##P<0.01 vs model; $P<0.05 vs Wendan Decoction;

[0026] Figure 9 Effects of Shuxin Wendan Decoction aqueous extract and Wendan Decoction aqueous extract on the viability of OGD-stimulated HL-1 cells; **P<0.01 vs blank; ##P<0.01 vs model; $P<0.05 vs Wendan Decoction. Detailed Implementation

[0027] The following detailed description illustrates the specific implementation method:

[0028] I. The drug for treating ischemic heart disease according to this invention

[0029] Based on clinical prescriptions for coronary atherosclerotic ischemic heart disease at their workplace, the inventor conducted the following analysis, including statistical analysis of drug efficacy, drug meridian tropism, drug four-qi (vital energy), and drug five-flavor (nutritional properties). Based on clinical case records, a total of 193 related Chinese medicinal herbs were involved. Finally, combining Ye Tianshi's theory of "initial illness with damp-heat in the meridians, and prolonged illness with blood damage entering the collaterals," and clinical experience, the inventor, after extensive experimentation, explored and summarized the following compound formula. This compound formula was applied clinically and significantly improved coronary artery blood supply in patients. Accompanying discomfort symptoms disappeared, and patients' energy and physical strength were significantly enhanced, confirming that the compound formula exhibited very good therapeutic effects. The dosage of each component within the following weight range showed good efficacy:

[0030] Pinellia ternata 5-10g, bamboo shavings 5-10g, immature bitter orange 5-10g, dried tangerine peel 10-15g, Poria cocos 5-10g, fresh ginger 5-10g, licorice root 5-10g, salvia miltiorrhiza 10-15g, ground beetle 5-10g, Coptis chinensis 3-5g, cinnamon twig 5-10g.

[0031] For patients with coronary heart disease of the phlegm-blood stasis type, the following compound formula has better efficacy: Pinellia ternata 10g, Bambusa textilis 10g, Citrus aurantium 10g, Citrus reticulata 15g, Poria cocos 7.5g, Zingiber officinale 5g, Glycyrrhiza uralensis 5g, Salvia miltiorrhiza 15g, Eupolyphaga sinensis 10g, Coptis chinensis 3g, Cinnamomum cassia 5g.

[0032] II. The preparation method of the drug (Shuxin Wendan Decoction) for treating ischemic heart disease of the present invention is as follows:

[0033] After weighing and mixing all the drugs to obtain 95.5g, soak them completely in 6 times the amount of distilled water for 60 minutes, decoct for 40 minutes each time, and decoct for 3 consecutive times. Then, mix the 3 decoctions and concentrate them to 62.8ml for use.

[0034] III. Experiment

[0035] (I) Effects of Shuxin Wendan Decoction on Mice with Myocardial Infarction

[0036] 1. Establishment of myocardial infarction model: After anesthetizing mice with isoflurane, the mice were fixed supine on a surgical board by endotracheal intubation and ventilator. After the left anterior chest of the mice was prepared and disinfected, a surgical incision of about 1 cm was made with straight scissors. The muscle tissue was bluntly dissected, and the heart was exposed at the 3rd-4th intercostal space on the left side of the sternum. The left anterior descending coronary artery was ligated with a 6-0 suture needle. The left ventricle was grayish-white, and ST segment elevation was observed on the two-lead electrocardiogram. The pleural cavity was closed layer by layer, and the model preparation was completed.

[0037] 2. Experimental group: After the myocardial infarction model was successfully established, the Shuxin Wendan Decoction prepared by the above method was administered to mice by gavage at a dose of 7g / kg (crude drug amount).

[0038] 3. Control group: After the myocardial infarction model was successfully established, 62.5g of the ancient formula Wendan Decoction was used, including 10g of Pinellia ternata, 10g of bamboo shavings, 10g of immature bitter orange, 15g of tangerine peel, 7.5g of Poria cocos, 5g of ginger, and 5g of licorice. The decoction was completely soaked in 6 times the amount of distilled water for 60 minutes, and decocted for 40 minutes each time, for a total of 3 times. The 3 decoctions were then mixed and concentrated to 70ml for gavage. The gavage dose was 7g / kg (raw amount of herbs).

[0039] 4. Control group: No surgical treatment was performed, and the same volume of normal saline was administered by gavage.

[0040] 5. Administration method: The administration time is 8:00 am every day, once a day by gavage, for 28 consecutive days.

[0041] 6. Indicator Observation:

[0042] (1) Cardiac function indicators (including left ventricular ejection fraction (LVEF) and cardiac output (CO), which are assessed by techniques such as echocardiography to evaluate the heart’s systolic and pumping functions).

[0043] (2) Heart (HE): The fixed heart tissue was embedded in paraffin, sectioned, dewaxed, graded hydration, stained with nuclear dye, differentiated, graded dehydration, cleared with xylene, and mounted for microscopic observation.

[0044] (3) During the treatment process, the animal’s electrocardiogram was measured regularly.

[0045] (4) The levels of CK and LDH in mouse serum were detected by ELISA.

[0046] (II) Effects of Shuxin Wendan Decoction on Rats with Coronary Atherosclerotic Heart Disease

[0047] 1. Establishment of a coronary atherosclerotic heart disease model: After rats were adapted to a normal diet for one week, they were fed a high-fat diet and injected intraperitoneally with vitamin D3 (150,000 U / kg) once a month for the first 3 months. The high-fat diet was continued for another 2 months, and the model was established for a total of 5 months.

[0048] 2. Experimental group: After the coronary atherosclerotic heart disease model was successfully established, the Shuxin Wendan Decoction prepared by the above method was administered to rats by gavage at a dose of 10g / kg (crude drug amount).

[0049] 3. Control group: After the coronary atherosclerotic heart disease model was successfully established, 62.5g of the ancient formula Wendan Decoction was used, including 10g of Pinellia ternata, 10g of bamboo shavings, 10g of immature bitter orange, 15g of tangerine peel, 7.5g of Poria cocos, 5g of ginger, and 5g of licorice. The herbs were completely soaked in 6 times the amount of distilled water for 60 minutes, decocted for 40 minutes each time, and decocted for 3 consecutive times. The 3 decoctions were then mixed and concentrated to 70ml for gavage. The gavage dose was 10g / kg (raw herbs).

[0050] 4. Control group: No surgical treatment was performed, and the same volume of normal saline was administered by gavage.

[0051] 5. Administration method: The administration time is 8:00 am every day, once a day by gavage, for 28 consecutive days.

[0052] 6. Indicator Observation:

[0053] (1) The levels of CHOL, TG, LDL and HDL in rat serum were measured by a fully automated biochemical analyzer, and AI = (CHOL-HDL) / HDL was calculated.

[0054] (2) The levels of MDA and SOD in rat serum were detected by ELISA.

[0055] (III) Effects of Shuxin Wendan Decoction on Myocardial Cells in a Hypoxic Model

[0056] 1. Observe the growth status of HL-1 mouse cardiomyocytes under a microscope. When the cell density reaches 70%-80%, perform routine ultraviolet disinfection for 30 minutes, culture in 10% DMEM medium, and equilibrate to room temperature.

[0057] 2. Prepare the required medications for each group: extract the water extracts of Shuxin Wendan Decoction and Wendan Decoction separately, soak them completely in 6 times the amount of distilled water for 60 minutes, decoct for 40 minutes each time, and decoct for 3 consecutive times. Then mix the 3 decoctions. The concentration of Shuxin Wendan Decoction is 0.30 g / mL; the concentration of Wendan Decoction is 0.16 g / mL.

[0058] 3. After pretreating cardiomyocytes with 100 μL of different concentrations (10 mg / mL, 20 mg / mL, 40 mg / mL, 80 mg / mL) of Shuxin Wendan Decoction and 80 mg / mL of Wendan Decoction in 3% FBS for 1 h, the cells were cultured in an anaerobic incubator at 37 °C for 12 h.

[0059] 4. Add 20 μL of CCK-8 reagent to each well, incubate at 37℃ in a 5% CO2 incubator for 2 hours, and measure the OD450 value.

[0060] (IV) Results and Analysis:

[0061] 1. Comparison of morphological results of cardiomyocytes in different groups of mice

[0062] HE (hematoxylin-eosin) staining showed that in the blank group, the myocardial tissue had a regular structure, uniform size, clear boundaries, oval cell nuclei, and no inflammatory cell infiltration. In the model group, the myocardial cells were irregularly arranged, with indistinct edges, free nuclei in the cytoplasm, and a large number of inflammatory cells infiltrating the cytoplasm. The cross-section showed cell swelling and increased intercellular spaces.

[0063] Compared to the model group, the morphology of myocardial cells in mice treated with Wendan Decoction and Shuxin Wendan Decoction was significantly improved, the degree of nucleus mobilization was improved to varying degrees, the intercellular spaces were reduced, and the infiltration of inflammatory cells was significantly reduced. Figure 1 .

[0064] 2. Effects on cardiac function in each group of mice

[0065] like Figure 2 As shown, echocardiography was used to assess left ventricular function in each group of mice. Figure 3 As shown, compared with the blank group, the EF and FS values ​​of the model group mice were significantly reduced (P<0.05); while the intervention of Wendan Decoction and Shuxin Wendan Decoction significantly improved the EF and FS values ​​of mice after myocardial infarction (P<0.05), and the EF and FS values ​​of Shuxin Wendan Decoction group were significantly higher than those of Wendan Decoction group.

[0066] 3. Effects of each group of mice on electrocardiogram

[0067] Electrocardiograms (ECGs) of mice in each group were examined. Compared to the control group, the model group mice exhibited transmural myocardial infarction with large Q waves in the QRS complex. After administration of Wendan Decoction and Shuxin Wendan Decoction, the incidence of myocardial infarction decreased to varying degrees, with the Shuxin Wendan Decoction group showing a more significant reduction. Figure 4 .

[0068] 4. Serum myocardial enzyme levels

[0069] like Figure 5 As shown, compared with the blank group, the serum CK and LDH levels in the model group were significantly increased, showing a significant difference. After treatment with Wendan Decoction and Shuxin Wendan Decoction, the CK and LDH levels decreased, and Shuxin Wendan Decoction was more effective than Wendan Decoction.

[0070] 5. Effects of different groups of rats on blood lipids and arteriosclerosis index

[0071] Changes in blood lipids in rats of each group were detected. Compared with the blank control group, the serum levels of CHOL, TG, and LDL in the model group rats were increased, while the HDL level was decreased. However, after administration of Wendan Decoction and Shuxin Wendan Decoction, the serum levels of CHOL, TG, and LDL all decreased, while the HDL level increased. Shuxin Wendan Decoction showed better effects than Wendan Decoction. There was no significant difference in HDL levels between Shuxin Wendan Decoction and Wendan Decoction. Figure 6The arteriosclerosis index (AI) of rats in each group was measured. Compared with the blank group, the AI ​​in the model group was increased. However, after administration of Wendan Decoction and Shuxin Wendan Decoction, the AI ​​decreased. Shuxin Wendan Decoction was more effective than Wendan Decoction. Figure 7 .

[0072] 6. Detection of serum oxidative stress levels in rats

[0073] like Figure 8 As shown, compared with the blank group, the serum MDA content in the model group increased and the SOD content decreased, showing a significant difference. After treatment with Wendan Decoction and Shuxin Wendan Decoction, the MDA content decreased and the SOD content increased, with Shuxin Wendan Decoction showing better effect than Wendan Decoction.

[0074] 7. Cell experiments

[0075] like Figure 9 As shown, compared with the blank group, cell viability decreased significantly after OD stimulation. Compared with the model group, cell viability increased after pretreatment with Shuxin Wendan Decoction aqueous extract, with significant differences between 40 μg / mL and 80 μg / mL, showing a gradient-dependent effect. 80 μg / mL Wendan Decoction aqueous extract significantly improved cell viability, but the effect was less pronounced than that of 80 μg / mL Shuxin Wendan Decoction aqueous extract.

[0076] IV. Clinical Case Analysis

[0077] 1. General information: 200 outpatients were admitted, including 40 patients aged 30-40, 60 patients aged 40-50, and 100 patients aged 50 and above.

[0078] 2. Diagnostic criteria: Refer to the diagnostic criteria of the State Administration of Traditional Chinese Medicine's "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine", the "Chest Pain (Phlegm and Blood Stasis)" in "Internal Medicine", and the "Macroscopic Diagnostic Criteria for Coronary Heart Disease with Phlegm and Blood Stasis" from the Institute of Basic Theory of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences.

[0079] 3. Inclusion criteria: (1) Age 35-85 years, no gender restriction; (2) Meets the above-mentioned TCM syndrome differentiation criteria;

[0080] Exclusion criteria: (1) Patients with infection or fever within the past 7 days; (2) Severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.) with hemodynamic changes; (3) Severe valvular heart disease (moderate lesions in one or more valves); (4) Severe heart failure; (5) Patients with acute exacerbation of chronic obstructive pulmonary disease, pulmonary heart disease, or respiratory failure; (6) Patients with severe liver or kidney dysfunction; (7) Pregnant women and lactating women.

[0081] 4. Treatment methods: A single-arm trial was conducted, and a standardized secondary prevention treatment plan for coronary heart disease was given for clinical treatment. When diabetes and hypertension were present, hypoglycemic and antihypertensive treatment plans were given, and Shuxin Wendan Decoction was added.

[0082] Ingredients: Pinellia ternata 5-10g, Bambusa textilis 5-10g, Citrus aurantium 5-10g, Citrus reticulata peel 10-15g, Poria cocos 5-10g, Zingiber officinale 5-10g, Glycyrrhiza uralensis 5-10g, Salvia miltiorrhiza 10-15g, Eupolyphaga sinensis 5-10g, Coptis chinensis 3-5g, Cinnamomum cassia twig 5-10g. Decoct in water and take warm, 30 minutes after breakfast and dinner. Follow-up visit once every 1-2 weeks. Treatment cycle is 2 months. Treatment will be based on the patient's four diagnostic methods, and the specific dosage of the herbs will be adjusted within the above range according to the patient's condition.

[0083] 5. Clinical efficacy evaluation criteria

[0084] Significant effect: Electrocardiogram showed a significant improvement in coronary artery blood supply, disappearance of discomfort symptoms, and a significant increase in energy and physical strength;

[0085] Improvement: After taking this product for 1-2 months, electrocardiograms show improved blood supply to the chronic coronary arteries, reduced or partially disappeared discomfort symptoms, and increased energy and physical strength;

[0086] Ineffective: Symptoms and signs do not improve or worsen.

[0087] The TCM syndrome score is formulated with reference to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" and "Internal Medicine of Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine. Based on the severity of the patient's symptoms, the corresponding main symptoms and concurrent symptoms are recorded as 0, 1, 2, 3, 4, and 6 points, respectively. The score records the changes in the TCM syndrome score before and after treatment with Shuxin Wendan Decoction.

[0088] 5.1 Treatment Results

[0089]

[0090] 5.2 Comparison of TCM syndrome scores before and after treatment

[0091]

[0092] Δ represents the difference between the initial syndrome score and the final TCM syndrome score; compared with the pre- and post-treatment scores in this group, #P<0.05

[0093] 5.3 Comparison of blood lipid levels before and after treatment in two groups of patients with phlegm-blood stasis syndrome

[0094]

[0095] TC is total cholesterol; TG is triglycerides; LDL-C is low-density lipoprotein cholesterol; HDL-C is high-density lipoprotein cholesterol; compared with the pre-treatment values ​​in this group, #P<0.05.

[0096] In the treatment of patients with Shuxin Wendan Decoction, 200 patients were treated with the drug of this invention, with 130 cases showing significant effect, 70 cases showing improvement, and 0 cases showing no effect, with a total effective rate of 100%. The drug is convenient to use, patients have good compliance during medication, and patients have high satisfaction and drug safety. In addition, clinical application studies have confirmed that the drug of this invention can effectively improve patients' TCM syndrome scores and dyslipidemia, showing good therapeutic effects.

Claims

1. A drug for treating coronary atherosclerotic ischemic heart disease of the phlegm-blood stasis type, characterized in that, The drug is composed of active pharmaceutical ingredients within the following weight ranges: Pinellia ternata 5-10g, bamboo shavings 5-10g, immature bitter orange 5-10g, dried tangerine peel 10-15g, Poria cocos 5-10g, fresh ginger 5-10g, licorice root 5-10g, salvia miltiorrhiza 10-15g, ground beetle 5-10g, Coptis chinensis 3-5g, cinnamon twig 5-10g.

2. The drug for treating coronary atherosclerotic ischemic heart disease of the phlegm-blood stasis type according to claim 1, characterized in that: The dosage of each raw material is as follows: Pinellia ternata 10g, Bambusa textilis 10g, Citrus aurantium 10g, Citrus reticulata 15g, Poria cocos 7.5g, Zingiber officinale 5g, Glycyrrhiza uralensis 5g, Salvia miltiorrhiza 15g, Eupolyphaga sinensis 10g, Coptis chinensis 3g, Cinnamomum cassia 5g.

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