A traditional Chinese medicine composition for treating coronary heart disease and a preparation method and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine research technology, specifically relating to a traditional Chinese medicine composition for treating coronary heart disease, its preparation method, and its application. The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Astragalus membranaceus 15-30 parts, Trichosanthes kirilowii 15-30 parts, Inula japonica 9-12 parts, Rubia cordifolia 9-12 parts, Ligusticum chuanxiong 9-12 parts, Salvia miltiorrhiza 15-30 parts, Leonurus japonicus 9-15 parts, Aucklandia lappa 6-9 parts, and Amomum villosum 3-6 parts. This traditional Chinese medicine composition has a good therapeutic effect on inflammatory factors in patients with coronary heart disease exhibiting qi deficiency and phlegm stasis syndrome, and no other adverse reactions such as liver or kidney damage have been observed in the patients.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine research technology, specifically relating to a traditional Chinese medicine composition for treating coronary heart disease, its preparation method, and its application. Background Technology

[0002] Coronary artery disease (CAD), also known as coronary atherosclerotic heart disease, is a condition characterized by myocardial ischemia, hypoxia, or necrosis. It is caused by atherosclerosis leading to narrowing or even blockage of the coronary arteries. Many factors are associated with its development. Besides traditional risk factors such as age, sex, hypertension, diabetes, hyperlipidemia, smoking, and alcohol consumption, new risk factors have been identified, including elevated homocysteine ​​(Hcy) levels, increased insulin resistance, and inflammatory factors. Currently, widely accepted pathogenesis theories include the fatty infiltration theory, the thrombosis theory, and the platelet aggregation theory. Influenced by lipids, thrombi, and platelets, the coronary arteries narrow, reducing blood flow and causing myocardial hypoxia, making it difficult to maintain normal vital functions and triggering angina attacks. Inflammatory responses are involved in the pathophysiological process of coronary heart disease. Recent studies have shown that the occurrence and progression of coronary heart disease are related to vascular endothelial dysfunction, microcirculatory disturbances, inflammation and immune responses.

[0003] Traditional Chinese medicine does not have a specific term for coronary heart disease. Based on its symptoms, it can be categorized under the TCM concepts of chest pain and true heart pain, and is reflected in several classic texts. The *Huangdi Neijing* (Yellow Emperor's Inner Classic) describes "chest pain," while the *Lingshu* (Spiritual Pivot) states: "The lungs are small and drink little… prone to chest pain and rebellious qi."

[0004] The *Suwen* (Plain Questions) chapter "On the Law of the Visceral Qi" states that those suffering from heart disease typically experience symptoms of pain and fullness, located in the chest, inner arms, ribs, hypochondrium, back, and between the shoulder blades. The *Jinkui Yaolue* (Essential Prescriptions of the Golden Chamber) elaborates on the specific causes and symptoms of "chest pain and heart pain": "The pulse should be examined for excess rather than deficiency... therefore, those with chest pain and heart pain have a rapid and wiry pulse." Furthermore, it mentions that mild cases of chest pain manifest as chest fullness, while severe cases manifest as chest pain. Based on specific manifestations, the severity of the illness is divided into two levels: chest fullness and chest pain. The *Elbow-Side Emergency Prescriptions* describes the specific symptoms of chest pain in considerable detail, with Volume Four stating: "Chest disease causes a feeling of fullness and sudden pain in the heart... vexation, spontaneous sweating, or pain radiating to the back." True heart pain is a more serious condition. The *Ling Shu* (Spiritual Pivot) states in the chapter on "Jue Diseases": "True heart pain causes the hands and feet to turn blue up to the joints; in severe cases, it manifests in the morning and death occurs in the evening." The *Treatise on the Origins and Symptoms of Various Diseases* states in the chapter on "Heart Diseases": "The heart is the master of all organs, responsible for storing the spirit. The heart's meridians are susceptible to injury; if injured, true heart pain will occur." The *Medical Compendium* states in the chapter on "Heart Pain": "True heart pain is characterized by sudden, severe pain... manifesting in the evening and death in the morning; it is incurable."

[0005] Many existing Chinese and Western medicine treatments for coronary heart disease still focus on "symptomatic relief" rather than "holistic regulation," and do not adequately cover the pathological basis of coronary heart disease in multiple aspects such as qi stagnation and blood stasis, phlegm obstruction, myocardial ischemia, and neuroendocrine imbalance. At the same time, although Western medicine has clear effects in anti-ischemia, anti-platelet, and lipid regulation, long-term use has prominent problems such as adverse reactions, tolerability, and individual differences. On the other hand, the use of Chinese medicine alone often has problems such as insufficient understanding of the mechanism of action, inconsistent efficacy evaluation standards, and limited onset speed and emergency intervention capabilities. Summary of the Invention

[0006] In view of the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition for treating coronary heart disease. This traditional Chinese medicine composition can synergistically regulate multiple targets, improve angina pectoris and hemorheology, and take into account both promoting blood circulation and removing blood stasis and calming the mind. In long-term management, it can reduce the dosage or side effects of Western medicine, thus making it more suitable for treating coronary heart disease, a chronic, complex, and fluctuating disease.

[0007] The specific technical solution provided by this invention is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating coronary heart disease, which is made from the following raw materials in parts by weight: 15-30 parts of Astragalus membranaceus, 15-30 parts of Trichosanthes kirilowii, 9-12 parts of Inula japonica, 9-12 parts of Rubia cordifolia, 9-12 parts of Ligusticum chuanxiong, 15-30 parts of Salvia miltiorrhiza, 9-15 parts of Leonurus japonicus, 6-9 parts of Aucklandia lappa, and 3-6 parts of Amomum villosum.

[0008] As a preferred embodiment of the present invention, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts Astragalus membranaceus, 30 parts Trichosanthes kirilowii, 10 parts Inula japonica, 10 parts Rubia cordifolia, 9 parts Ligusticum chuanxiong, 30 parts Salvia miltiorrhiza, 9 parts Leonurus japonicus, 9 parts Aucklandia lappa, and 6 parts Amomum villosum.

[0009] In a second aspect, the present invention provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: Weigh out the following ingredients according to their weight proportions: Astragalus membranaceus, Trichosanthes kirilowii, Inula japonica, Rubia cordifolia, Ligusticum chuanxiong, Salvia miltiorrhiza, Leonurus japonicus, Aucklandia lappa, and Amomum villosum. The weighed medicinal materials are mixed, soaked in water, decocted, and the decoction is collected to obtain the Chinese herbal composition.

[0010] The soaking in water involves adding water equivalent to 2 to 4 times the total weight of the medicinal materials and soaking for 20 to 30 minutes. The decoction is prepared by decocting 2 to 3 times, each time for 30 to 60 minutes, and the decoction is collected.

[0011] This invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating coronary heart disease.

[0012] As a preferred embodiment of the present invention, the traditional Chinese medicine composition is used to prepare a drug for treating coronary heart disease with qi deficiency and phlegm stasis syndrome.

[0013] More preferably, the traditional Chinese medicine composition is used to prepare a drug for treating coronary heart disease with qi deficiency and phlegm stasis syndrome, reducing the influence of inflammatory factors, the main pathological factor.

[0014] The present invention also provides a traditional Chinese medicine preparation for treating coronary heart disease, wherein the traditional Chinese medicine composition is the sole effective ingredient.

[0015] In a preferred embodiment of the present invention, the traditional Chinese medicine preparation is compounded from the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0016] More preferably, the traditional Chinese medicine preparation is an oral preparation.

[0017] More preferably, the oral formulation is selected from capsules, tablets or granules.

[0018] Based on Professor Zhou Mingxin's academic thought on the "Pai Ta Zong Yang Method," this invention team selected the following herbs: Astragalus membranaceus, Trichosanthes kirilowii, Inula japonica, Rubia cordifolia, Ligusticum chuanxiong, Salvia miltiorrhiza, Leonurus japonicus, Aucklandia lappa, and Amomum villosum. Astragalus membranaceus and Trichosanthes kirilowii are the principal herbs; one tonifies Qi and raises Yang, while the other relieves chest congestion and eliminates phlegm. Together, they invigorate the heart Yang and resolve phlegm, laying the foundation for the entire formula to support the body's resistance and eliminate pathogenic factors. The assistant herbs, Inula japonica and Rubia cordifolia, are combined using the principle of "descending before ascending." Inula japonica lowers Qi, resolves phlegm, softens hardened masses, and unblocks the meridians, while Rubia cordifolia invigorates blood, removes blood stasis, and stops bleeding. Together, they lower rebellious Qi without harming the body's resistance and unblock the meridians without depleting Qi. Ligusticum chuanxiong and Salvia miltiorrhiza are used synergistically. Ligusticum striatum promotes qi and blood circulation, ascending to the head and eyes; Salvia miltiorrhiza promotes blood circulation, removes blood stasis, cools the blood, and calms the mind. Together, they invigorate blood circulation, unblock the meridians, and regulate qi and blood, promoting the removal of stasis and the regeneration of new qi. They serve as assistant herbs. Motherwort, Aucklandia lappa, and Amomum villosum are added as adjuvants. Motherwort promotes diuresis and invigorates blood circulation, assisting the blood-stasis-removing effects of Salvia miltiorrhiza and Ligusticum striatum, while preventing the warming and drying effects of other herbs from damaging yin. Aucklandia lappa and Amomum villosum regulate qi and invigorate the spleen, assisting Astragalus membranaceus in tonifying qi, while preventing the cloying and cloying effects of Trichosanthes kirilowii and Inula japonica from harming the stomach. All the herbs in the formula work in tandem, tonifying qi without causing stagnation, invigorating blood circulation without harming the body's vital energy, suppressing adverse qi without damaging yang, resolving phlegm and unblocking the meridians. Together, they achieve the effects of stimulating heart yang, unblocking the meridians and removing blood stasis, and regulating qi. The functions of each herb complement each other, thereby achieving the purpose of warming and tonifying ancestral qi, promoting ancestral yang, opening up and draining phlegm, clearing the lungs and resolving phlegm, circulating the heart vessels, and regulating the middle jiao, ultimately aiming to expel ancestral yang.

[0019] Astragalus, with its sweet and slightly warm properties, enters the spleen and lung meridians, and has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing edema, and generating fluids and nourishing blood. Modern pharmacological studies suggest that astragalus mainly contains polysaccharides, flavonoids, triterpenoids, and other substances, which can regulate immunity, reduce inflammation, and have antioxidant effects. Studies have shown that astragalus polysaccharide (APS), an extract of astragalus, improves myocardial energy metabolism and stabilizes normal myocardial function by regulating the AMPK pathway; astragaloside IV (AS-IV) can inhibit the expression of apoptosis proteins in cardiomyocytes.

[0020] Trichosanthes kirilowii, sweet and slightly bitter in taste, cold in nature, and enters the lung and stomach meridians, has the effects of clearing heat and resolving phlegm, relieving chest congestion and dissipating nodules. Modern pharmacological studies have found that Trichosanthes kirilowii contains active substances such as amino acids and glycosides, which can dilate coronary arteries, improve microcirculation, prevent arteriosclerosis, prevent platelet aggregation, inhibit inflammation, and protect ischemic myocardium.

[0021] Inula japonica, slightly warm in nature, enters the lung, spleen, and stomach meridians, and has the effects of lowering qi, resolving phlegm, promoting diuresis, and stopping vomiting. Modern pharmacological studies have found that Inula japonica contains sesquiterpenes and flavonoids, and these active ingredients exert anti-atherosclerotic and anti-myocardial damage effects by regulating signal transduction and angiogenesis.

[0022] Madder root, bitter and cold in nature, enters the liver meridian and has the effects of cooling the blood, removing blood stasis, stopping bleeding, and regulating menstruation. Modern pharmacological studies have found that it contains small molecule, cyclohexyl peptide, and polysaccharide chemical substances, which can produce anti-inflammatory, antioxidant, hemostatic, and blood stasis-removing effects on the human body.

[0023] Chuanxiong (Ligusticum striatum), pungent in taste and warm in nature, enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting blood circulation, removing blood stasis, reducing swelling, and draining pus. Modern pharmacological studies have shown that Chuanxiong has pharmacological effects such as paralyzing the central nervous system, stimulating the medullary respiratory center and vasomotor center, directly dilating peripheral blood vessels, increasing coronary blood flow, lowering blood pressure, and antibacterial activity. Its main indications are closely related to the pathophysiological changes of cardiovascular and cerebrovascular diseases, thrombosis, and pain, such as ischemic encephalopathy, coronary heart disease, hyperviscosity syndrome, and thromboangiitis obliterans.

[0024] Danshen, bitter in taste and slightly cold in nature, enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, warming the meridians and relieving pain, clearing the heart and relieving irritability, and cooling the blood and reducing swelling. Modern pharmacological studies have found that Danshen contains active ingredients such as tanshinone, salvianolic acid, and tanshinone, which play a role in protecting the myocardium, resisting arteriosclerosis, inhibiting platelet aggregation, and reducing myocardial ischemia damage through related mechanisms.

[0025] Motherwort is slightly cold in nature and has a bitter and pungent taste. It enters the heart, liver, and bladder meridians and has the effects of promoting blood circulation, regulating menstruation, diuresis, and reducing swelling. Modern pharmacological studies have found that motherwort and its active ingredients have multiple effects such as anti-oxidation, antibacterial, anti-inflammatory, and antithrombotic properties.

[0026] Costus root has a pungent and bitter aroma, is warm in nature, and enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It has the effects of promoting qi circulation and relieving pain, strengthening the spleen and promoting digestion. Modern pharmacological studies have shown that costus root has pharmacological effects such as antibacterial, anti-inflammatory, antioxidant, anticoagulant, and antitumor properties.

[0027] Amomum villosum has a pungent taste and warm properties, and enters the spleen, stomach, and kidney meridians. It has the effects of resolving dampness and stimulating appetite, warming the spleen and stopping diarrhea, regulating qi and calming the fetus. Modern research shows that the characteristic components of Amomum villosum are mainly volatile oils and flavonoids, and its clinical pharmacological effects include anti-inflammatory, choleretic, and analgesic properties.

[0028] When combined, these herbs work together to warm and tonify the vital energy and promote the circulation of yang energy, and are used to treat coronary heart disease with qi deficiency and phlegm stasis syndrome.

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows: The traditional Chinese medicine composition provided by this invention has a clear compatibility relationship, a thoroughly elucidated mechanism, and a unified standard for evaluating efficacy. It has a good therapeutic effect on patients with coronary heart disease and qi deficiency and phlegm stasis syndrome, with good onset speed and emergency intervention capability. At the same time, it can improve patients' clinical symptoms, reduce inflammatory factors, and has significant clinical efficacy with no adverse reactions observed. Detailed Implementation

[0030] The technical solutions in the embodiments of the present invention will be further described in detail below. The described embodiments are only a part of the present invention and are used to explain the present invention, but are not intended to limit the present invention. Therefore, other embodiments obtained by other people skilled in the art without creative labor are all within the protection scope of the present invention.

[0031] Example 1 A traditional Chinese medicine composition for treating coronary heart disease is made from the following raw materials: Astragalus membranaceus 15g, Trichosanthes kirilowii 15g, Inula japonica 9g, Rubia cordifolia 9g, Ligusticum chuanxiong 9g, Salvia miltiorrhiza 15g, Leonurus japonicus 9g, Aucklandia lappa 6g, and Amomum villosum 3g.

[0032] Example 2 A traditional Chinese medicine composition for treating coronary heart disease is made from the following raw materials: Astragalus membranaceus 30g, Trichosanthes kirilowii 30g, Inula japonica 12g, Rubia cordifolia 12g, Ligusticum chuanxiong 12g, Salvia miltiorrhiza 30g, Leonurus japonicus 15g, Aucklandia lappa 9g, and Amomum villosum 6g.

[0033] Example 3 A traditional Chinese medicine composition for treating coronary heart disease is made from the following raw materials: Astragalus membranaceus 20g, Trichosanthes kirilowii 25g, Inula japonica 10g, Rubia cordifolia 10g, Ligusticum chuanxiong 10g, Salvia miltiorrhiza 20g, Leonurus japonicus 12g, Aucklandia lappa 8g, and Amomum villosum 5g.

[0034] Example 4 A traditional Chinese medicine composition for treating coronary heart disease is made from the following raw materials: Astragalus membranaceus 25g, Trichosanthes kirilowii 25g, Inula japonica 10g, Rubia cordifolia 10g, Ligusticum chuanxiong 10g, Salvia miltiorrhiza 18g, Leonurus japonicus 12g, Aucklandia lappa 9g, and Amomum villosum 6g.

[0035] Example 5 A traditional Chinese medicine composition for treating coronary heart disease is made from the following raw materials: Astragalus membranaceus 15g, Trichosanthes kirilowii 18g, Inula japonica 9g, Rubia cordifolia 9g, Ligusticum chuanxiong 12g, Salvia miltiorrhiza 30g, Leonurus japonicus 10g, Aucklandia lappa 8g, and Amomum villosum 3g.

[0036] Example 6 A traditional Chinese medicine composition for treating coronary heart disease is made from the following ingredients: Astragalus membranaceus 30g, Trichosanthes kirilowii 30g, Inula japonica 10g, Rubia cordifolia 10g, Ligusticum chuanxiong 9g, Salvia miltiorrhiza 30g, Leonurus japonicus 9g, Aucklandia lappa 9g, Amomum villosum 6g.

[0037] The traditional Chinese medicine compositions provided in Examples 1-6 above were all prepared according to the following methods: Combine the weighed medicinal materials, add water equal to twice the total weight of the medicinal materials, soak for 20 minutes, boil the liquid and simmer for 60 minutes, filter out the liquid and keep it; add water equal to twice the amount of the residue, boil the liquid and simmer for 30 minutes, combine the two liquids and filter out the liquid to obtain the final product.

[0038] Example 7 A traditional Chinese medicine composition for treating coronary heart disease, differing from Example 1 only in its preparation method, specifically: Combine the weighed medicinal materials, add water equivalent to 4 times the total weight of the medicinal materials, soak for 30 minutes, boil the liquid and simmer for 60 minutes, filter out the liquid and keep it; add 4 times the amount of water to the residue, boil the liquid and simmer for 30 minutes, combine the two liquids and filter out the liquid to obtain the final product.

[0039] Since the effects of the traditional Chinese medicine compositions provided in Examples 1 to 7 are basically similar, the following description will only use the traditional Chinese medicine composition provided in Example 6 as an example to illustrate the effects.

[0040] 1. Clinical data and experimental methods Sixty-six patients diagnosed with coronary heart disease due to Qi deficiency and phlegm stasis syndrome at the Department of Cardiology, CCU, and Cadre Ward of the Autonomous Region Traditional Chinese Medicine Hospital from January to December 2023 were selected. A randomized, single-blind, controlled trial design was adopted. The 66 patients were randomly divided into two groups: a control group and an experimental group, with 33 patients in each group. The clinical effect of the drug was demonstrated by observing the differences before and after the trial.

[0041] 1.1 Diagnostic Criteria 1.1.1 Traditional Chinese Medicine Diagnosis This standard is formulated based on the diagnostic criteria and syndrome differentiation (qi deficiency, phlegm and blood stasis) for chest pain in traditional Chinese medicine, as outlined in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs".

[0042] (1) Main symptoms: chest pain and chest tightness.

[0043] (2) Secondary symptoms: palpitations, shortness of breath, fatigue, obesity and phlegm; epigastric fullness, poor appetite, heaviness throughout the body, dull complexion or cyanosis of the lips. Tongue and pulse: The tongue is dark purple, with visible ecchymosis and petechiae, and the tongue coating is turbid and greasy or white and slippery.

[0044] If the primary symptoms are as described above, and at least two secondary symptoms are present, the clinical diagnosis can be supplemented by tongue and pulse examination.

[0045] 1.1.2 Western Medicine Diagnosis Currently, the main criteria for clinical diagnosis of coronary heart disease include the following: (1) The Guidelines for the Diagnosis and Treatment of Chronic Stable Angina Pectoris were published in 2007 and were drafted by the Chinese Society of Cardiology.

[0046] (2) The Guidelines for the Diagnosis and Treatment of Unstable Angina and Non-ST Segment Elevation Myocardial Infarction were published in 2011 and were drafted by the Chinese Medical Association.

[0047] (3) The Guidelines for the Management of Chronic Stable Angina, published in 2007, were developed by the American Heart Association (AHA).

[0048] (4) "Diagnosis and Treatment of Unstable Angina and Non-ST Segment Elevation Myocardial Infarction", published in 2007, was developed by the American College of Cardiology Foundation (ACCF).

[0049] Coronary angiography or coronary CTA is an indispensable tool in diagnosis.

[0050] 1.2 Case Inclusion Criteria (1) Age greater than 18 years and less than or equal to 80 years.

[0051] (2) Those who have the main symptoms of chest pain and whose TCM diagnosis and differentiation are consistent with the syndrome of chest pain with qi deficiency and phlegm stasis.

[0052] (3) Patients diagnosed with stable angina pectoris by Western medicine, whether they are mild, moderate or severe, are eligible.

[0053] (4) Informed consent and voluntary participation.

[0054] 1.3 Case Exclusion Criteria (1) Patients with systolic blood pressure ≥180 mmHg and / or diastolic blood pressure ≥110 mmHg, acute coronary syndrome, severe cardiopulmonary insufficiency (heart function > grade II), severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), acute myocardial infarction, severe angina pectoris, severe aortic stenosis, or hypertrophic obstructive cardiomyopathy; or those with a history of myocardial infarction or revascularization within the past 3 months. (2) Liver dysfunction (ALT, AST > 1.5 times the upper limit of normal reference value), renal dysfunction; (3) Those who have had a stroke within the past 6 months (excluding lacunar infarction); (4) Suffering from diseases such as connective tissue disorders or malignant tumors; (5) Has participated in other clinical studies within the past 3 months; (6) Individuals with allergic constitutions or allergies to multiple medications; (7) Patients with severe brain or hematopoietic system disorders, or mental illness; (8) Pregnant and lactating women.

[0055] 1.4 Case Exclusion Criteria (1) Those who discontinue treatment midway; (2) Those who have taken other medications; (3) Those for whom data cannot be collected; (4) Cases that were found to have been mistakenly included after inclusion; (5) Those who experience severe adverse reactions; (6) Those who are unable to take medication, undergo examinations and treatments as required after being admitted.

[0056] 1.5 Criteria for Terminating the Test (1) Those who were lost to follow-up during the observation period or dropped out due to personal reasons; (2) Subjects with poor compliance, who did not take medication in a standardized manner, which affected the judgment of clinical treatment efficacy and caused blood indicators to be discriminated against; (3) Those who develop serious complications or side effects and are not suitable to continue treatment.

[0057] 2. Research Methods 2.1 Clinical Grouping A randomized controlled trial design was adopted. The sample size was determined using the R language pwr packages tool. Initially, the effective size d = 0.80 (Cohen's criterion), statistical power 1-β = 0.9, and significance level α = 0.05 were assumed. Based on the calculations, approximately 28 cases were required in each group. Considering a maximum allowable dropout rate of 15% during the observation period, the final sample size was determined to be 66 cases. The 66 cases were randomly divided into two groups: a control group and an experimental group, each with 33 cases. The random sequences were placed in pre-prepared sealed envelopes. Researchers assessed the eligibility of the subjects; only after eligibility was confirmed could the envelopes be opened in sequence for sample grouping.

[0058] 2.2 Treatment Plan Control group: Conventional Western medicine treatment: Aspirin 100mg to inhibit platelet aggregation, atorvastatin calcium tablets 20mg to regulate lipids and stabilize plaques, isosorbide mononitrate 40mg to dilate coronary arteries and improve myocardial blood supply, metoprolol 47.5mg to control ventricular rate and reduce myocardial oxygen consumption, etc. Experimental group: In addition to the control group, the traditional Chinese medicine composition provided in Example 6 of this application was administered, one dose per day, twice a day. The prescription was provided by the Traditional Chinese Medicine Preparation Room of the Autonomous Region Traditional Chinese Medicine Hospital, each bag containing 220ml. One course of treatment was 30 consecutive days.

[0059] 2.3 Observation Indicators The main efficacy observation indicators were: high-sensitivity C-reactive protein, interleukin-6, interleukin-18, interleukin-37, and tumor necrosis factor were extracted from patients in the control group and the experimental group 30 days after routine treatment.

[0060] Secondary efficacy endpoints: (1) Seattle Angina Score: including the average number of angina attacks, the degree of activity limitation caused by angina, the number of times nitroglycerin is used, and treatment satisfaction.

[0061] (2) Traditional Chinese Medicine Syndrome Scale Scoring: This scale mainly consists of primary symptoms: chest pain and chest tightness; secondary symptoms: palpitations, shortness of breath, fatigue, obesity with excessive phlegm; epigastric fullness, poor appetite, heaviness throughout the body, dull complexion or cyanosis of the lips; and tongue and pulse: the tongue is dark purple, with visible ecchymosis and petechiae, and the tongue coating is turbid and greasy or white and slippery. The primary symptoms are assigned scores of 0, 2, 4, and 6 according to their severity, and the secondary symptoms are assigned scores of 0, 1, 2, and 3 according to their severity. The results of the two groups were compared to observe whether the traditional Chinese medicine composition of this invention could improve the clinical symptoms and inflammatory indicators of patients with coronary heart disease with qi deficiency and phlegm stasis syndrome, and improve the clinical efficacy of the patients.

[0062] 2.4 Criteria for Evaluating Therapeutic Effect 2.4.1 Clinical efficacy of Western medicine Based on the Seattle Angina Scale score, the significance of the total scores of each item before and after treatment was used as the criterion.

[0063] 2.4.2 Clinical efficacy of traditional Chinese medicine The symptoms of coronary heart disease with Qi deficiency and phlegm stasis syndrome were quantitatively scored according to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine".

[0064] Evaluation criteria for TCM syndrome differentiation and efficacy indicators: Significant effect: TCM symptoms and signs basically disappear or significantly improve, and the total score decreases by ≥70%; Effective: Symptoms and signs in Traditional Chinese Medicine improved, and the total score decreased by 30% to 69%; Ineffective: The symptoms and signs of TCM do not improve significantly, or even worsen, with a score ratio of <30%.

[0065] Formula: Percentage of therapeutic effect = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%.

[0066] 2.5 Safety Evaluation Indicators The patient's blood routine, liver function, kidney function, and coagulation function were tested before and after treatment to assess the drug's good safety profile.

[0067] 3. Quality Control The samples required for this study were collected using a combination of traditional Chinese and Western medicine diagnostic criteria, as well as inclusion and exclusion criteria. Cases included in the sample required TCM syndrome differentiation by an associate chief physician or higher-level medical practitioner. In case of disagreement during differentiation, the results needed to be agreed upon by two or more associate chief physicians. All data analysis was conducted by professional technicians. A double-entry method was used for entering basic patient information to ensure the accuracy and objectivity of both sets of information. All personnel participating in this trial possessed professional knowledge and technical skills.

[0068] 4. Results 4.1 Comparison of total TCM syndrome scores before and after treatment in the two groups of patients The rank-sum test was used to determine whether there were differences in the TCM syndrome scores between the two groups. Before treatment, the inter-group comparison showed P > 0.05, indicating comparability. Within-group comparison, the scores of both the experimental and control groups decreased (P < 0.001). After treatment, the inter-group comparison showed P < 0.001, indicating that the TCM syndrome scores of both groups decreased, but the improvement in the experimental group was more significant, and the difference before and after treatment was statistically significant (P < 0.001), as shown in Table 1.

[0069] Table 1 Comparison of TCM syndrome scores before and after treatment in the two groups of patients Note: Compared with before treatment ▲▲ P < 0.001.

[0070] 4.2 Analysis of TCM Syndrome-Based Therapy A comparison of the effective rates of TCM syndromes between the two groups showed that the effective rate in the experimental group was 90.91%, while the effective rate in the control group was 69.70%. Using the rank-sum test, P < 0.001, indicating a statistically significant difference. This demonstrates that the traditional Chinese medicine composition provided by this invention can effectively improve the TCM syndrome scores of patients. Through comparative analysis of the efficacy of the TCM syndromes in the experimental and control groups, the total TCM syndrome scores of both groups decreased. The total effective rate in the experimental group was 90.91%, while the total effective rate in the control group was 69.70%, showing a statistically significant difference. This indicates that the Paita Zongyang formula can significantly improve TCM syndromes, and is superior to the control group (see Table 2).

[0071] Table 2. Effective rate of improvement in TCM syndromes before and after treatment in the two groups of patients (cases) 4.3 Comparison of inflammatory markers before and after treatment in the two groups of patients 4.3.1 Comparison of high-sensitivity C-reactive protein levels before and after treatment in the two groups of patients. The rank-sum test was used to examine whether there were differences in the grouping of high-sensitivity C-reactive protein between the two groups. (Treatment groups...)

[0072] The intergroup comparisons showed P > 0.05, indicating comparability. Within-group comparisons showed a decrease in both groups (P < 0.05); after treatment, the intergroup comparisons showed P > 0.05, and the differences between the two groups before and after treatment showed P > 0.05 (see Table 3).

[0073] Table 3 Comparison of high-sensitivity C-reactive protein (hSRP) levels before and after treatment in the two groups of patients (unit: mg / L) Note: Compared with before treatment ▲ P < 0.05 4.3.2 Comparison of interleukin levels before and after treatment in the two groups of patients. The rank-sum test was used to examine whether there were differences in interleukin-6 and interleukin-37 between and within the two groups; the t-test was used to examine whether there were differences in interleukin-37 between and within the two groups. For interleukin-6, 18, and 37: the inter-group comparison of interleukin-6, 18, and 37 before treatment showed P > 0.05, indicating comparability. Within the treatment group, the levels of interleukin-6, 18, and 37 decreased in both the experimental and control groups (P < 0.001). After treatment, the inter-group comparison of interleukin-18 and 37 showed P < 0.05, while the inter-group comparison of interleukin-6 after treatment showed P > 0.05. Furthermore, there were significant differences in the levels of interleukin-18 and 37 before and after treatment between the two groups (P < 0.05), but no significant difference in the level of interleukin-6 (P > 0.05). This indicates that the traditional Chinese medicine composition provided by this invention can reduce IL-18 and IL-37 levels, with significantly better efficacy than the control group (see Table 4).

[0074] Table 4 Comparison of interleukin levels before and after treatment in the two groups of patients Note: Compared with before treatment ▲▲ P<0.001, compared with before treatment ▲ P<0.05.

[0075] 4.3.3 Tumor necrosis factor-α before and after treatment in both groups of patients The rank-sum test was used to examine whether there were differences in tumor necrosis factor-α levels between the two groups. Before treatment, the inter-group comparison showed P > 0.05, indicating comparability. Within-group comparisons showed a decrease in both groups (P < 0.05); after treatment, the inter-group comparison showed P > 0.05, and the difference between the two groups before and after treatment showed P > 0.05 (see Table 5).

[0076] Table 5 Comparison of tumor necrosis factor-α (ng / L) before and after treatment in the two groups of patients. Note: Compared with before treatment ▲▲ P < 0.001.

[0077] 4.4 Comparison of Seattle Angina Scale scores before and after treatment between the two groups of patients The rank-sum test was used to examine whether there was a difference in Seattle Angina Scale scores between the two groups. Before treatment, the inter-group comparison showed P > 0.05, indicating comparability. Within-group comparison, both the experimental and control groups showed a decrease in scores (P < 0.001); after treatment, the inter-group comparison showed P < 0.001, indicating that both groups experienced a decrease in Seattle Angina Scale scores, but the improvement was more significant in the experimental group, and the difference before and after treatment was statistically significant (P < 0.001). This demonstrates that the traditional Chinese medicine composition provided by this invention has a strong effect in reducing the average number of angina attacks, alleviating the degree of activity limitation caused by angina, and reducing the frequency of nitroglycerin use, with clinical efficacy superior to the control group (see Table 6).

[0078] Table 6 Comparison of Seattle Angina Scale scores before and after treatment in the two groups of patients. Note: Compared with before treatment ▲▲ P < 0.001.

[0079] 5. Security Analysis The traditional Chinese medicine composition provided by this invention showed no significant changes in liver function, kidney function, blood routine and other safety indicators before and after treatment, and had no adverse reactions, indicating that it is safe for clinical use.

[0080] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating coronary heart disease, characterized in that, It is made from the following raw materials by weight: Astragalus membranaceus 15-30 parts, Trichosanthes kirilowii 15-30 parts, Inula japonica 9-12 parts, Rubia cordifolia 9-12 parts, Ligusticum chuanxiong 9-12 parts, Salvia miltiorrhiza 15-30 parts, Leonurus japonicus 9-15 parts, Aucklandia lappa 6-9 parts, Amomum villosum 3-6 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 30 parts Astragalus membranaceus, 30 parts Trichosanthes kirilowii, 10 parts Inula japonica, 10 parts Rubia cordifolia, 9 parts Ligusticum chuanxiong, 30 parts Salvia miltiorrhiza, 9 parts Leonurus japonicus, 9 parts Aucklandia lappa, and 6 parts Amomum villosum.

3. A method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, Includes the following steps: Weigh out the following ingredients according to their weight proportions: Astragalus membranaceus, Trichosanthes kirilowii, Inula japonica, Rubia cordifolia, Ligusticum chuanxiong, Salvia miltiorrhiza, Leonurus japonicus, Aucklandia lappa, and Amomum villosum. The weighed medicinal materials are mixed, soaked in water, decocted, and the decoction is collected to obtain the Chinese herbal composition.

4. The preparation method according to claim 3, characterized in that, The soaking in water involves adding water equivalent to 2 to 4 times the total weight of the medicinal materials and soaking for 20 to 30 minutes. The decoction is prepared by decocting 2 to 3 times, each time for 30 to 60 minutes, and the decoction is collected.

5. Use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for treating coronary heart disease.

6. The application according to claim 5, characterized in that, The traditional Chinese medicine composition is used to prepare a drug for treating coronary heart disease with qi deficiency and phlegm stasis syndrome.

7. A pharmaceutical preparation for treating coronary heart disease, characterized in that, It uses the traditional Chinese medicine composition described in claim 1 as the sole effective ingredient.

8. The pharmaceutical preparation according to claim 7, characterized in that, The pharmaceutical preparation is a compound of the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

9. The pharmaceutical preparation according to claim 8, characterized in that, The pharmaceutical preparation is an oral preparation.

Images