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

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating coronary heart disease with yin deficiency, a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Gualou 9-15 parts, Shengdi 9-15 parts, Maidong 9-12 parts, Chishao 9-12 parts, Hongjingtian 9-15 parts, Dangshen 6-9 parts, Dangui 6-9 parts, Danshen 9-15 parts, and Chixiangcao 6-9 parts. The traditional Chinese medicine composition has a better curative effect on coronary heart disease, and no liver and kidney injury and other adverse reactions occur in 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 yin deficiency syndrome of coronary heart disease, its preparation method, and its application. Background Technology

[0002] Coronary atherosclerotic heart disease (CHD) is a heart condition caused by narrowing or blockage of the coronary arteries due to atherosclerosis, leading to myocardial ischemia, hypoxia, and even necrosis. It is a type of ischemic cardiomyopathy and one of the most common organ diseases caused by atherosclerosis. Currently, it is the leading cause of death and disability worldwide, involving multiple risk factors such as gender, smoking, obesity, family history, history of diabetes, history of hypertension, dyslipidemia, and systemic inflammation.

[0003] Xinjiang, located in Northwest my country and in the heart of Eurasia, is one of the world's most inland regions. Its dry and cold climate, coupled with the prevalence of rich, fatty, spicy, and fried foods in the diet, easily damages the spleen and stomach, leading to stagnation and obstruction of qi and blood. The combination of spicy and hot foods with this stagnant qi further depletes yin fluids, and the longer this continues, the more severe the yin deficiency becomes, resulting in poor blood and qi circulation, blocked meridians, and ultimately, chest pain. Therefore, in the diagnosis of chest pain, symptoms such as chest tightness, dull chest pain, dry mouth, foul breath, dry or constipated stools, poor appetite, a reddish tongue with little coating, and a thready pulse are common in arid Xinjiang, indicating a prevalence of heart and kidney yin deficiency. Studies have shown that traditional Chinese medicine can significantly improve yin deficiency symptoms and is an important supplement to the treatment of yin deficiency in coronary heart disease. The limitations of existing Chinese and Western medicine treatments for coronary heart disease lie in the fact that while Western medicines have a faster onset of action and are suitable for acute control, they mainly focus on single-target interventions such as vasodilation, antiplatelet therapy, and lipid regulation. They often only address the symptoms of "excess" and cannot address the underlying deficiency issues common in coronary heart disease under the background of Yin deficiency syndrome, such as deficiency of both heart Yin and Qi, internal heat due to Yin deficiency, and malnourishment of the heart vessels. At the same time, long-term use may also lead to limitations such as tolerance, gastrointestinal reactions, and bleeding risks. In contrast, while existing Chinese medicine treatments emphasize holistic regulation, there is still a lack of Chinese medicine combinations that can nourish Yin and clear heat, invigorate Qi and promote blood circulation, and simultaneously improve multidimensional symptoms such as chest pain, palpitations, insomnia, and fatigue in the specific population with "Yin deficiency syndrome," while also having good safety. Summary of the Invention

[0004] In view of the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition for treating Yin deficiency syndrome in coronary heart disease. The traditional Chinese medicine composition has the effects of "nourishing Yin and heart, promoting blood circulation and unblocking collaterals, calming the mind and soothing the nerves". It plays a supplementary role in addressing the shortcomings of existing treatments, such as insufficient regulation of Yin deficiency, inadequate treatment of both symptoms and root causes, and limited long-term management effects.

[0005] 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 Yin deficiency syndrome in coronary heart disease, which is made from the following raw materials in parts by weight: Trichosanthes kirilowii 9-15 parts, Rehmannia glutinosa 9-15 parts, Ophiopogon japonicus 9-12 parts, Paeonia lactiflora 9-12 parts, Rhodiola rosea 9-15 parts, Codonopsis pilosula 6-9 parts, Angelica sinensis 6-9 parts, Salvia miltiorrhiza 9-15 parts, and Cirsium japonicum 6-9 parts.

[0006] As a preferred embodiment of the present invention, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts of Trichosanthes kirilowii, 15 parts of Rehmannia glutinosa, 12 parts of Ophiopogon japonicus, 9 parts of Paeonia lactiflora, 15 parts of Rhodiola rosea, 9 parts of Codonopsis pilosula, 9 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, and 6 parts of Citrus aurantium.

[0007] 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: Trichosanthes kirilowii, Rehmannia glutinosa, Ophiopogon japonicus, Paeonia lactiflora, Rhodiola rosea, Codonopsis pilosula, Angelica sinensis, Salvia miltiorrhiza, and Cirsium japonicum. Mix the weighed herbs, soak them in water, decoct them, and collect the decoction to obtain the Chinese herbal composition.

[0008] In a preferred embodiment of the present invention, 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 decocting involves decocting 2 to 3 times, each time for 30 to 60 minutes, and collecting the decoction.

[0009] This invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating coronary heart disease.

[0010] As a preferred embodiment of the present invention, the traditional Chinese medicine composition is used to prepare a medicine for coronary heart disease with yin deficiency syndrome.

[0011] Preferably, the traditional Chinese medicine composition is used to prepare a treatment for myocardial ischemia, angina pectoris, myocardial infarction, and ischemic heart disease.

[0012] The present invention also provides a traditional Chinese medicine preparation for treating Yin deficiency syndrome in coronary heart disease, comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients or carriers.

[0013] This invention uses nourishing yin and moistening dryness, promoting body fluid and relieving irritability as the main treatment principles to create an effective prescription for treating yin deficiency syndrome in coronary heart disease. This formula uses Trichosanthes kirilowii, Rehmannia glutinosa, and Ophiopogon japonicus as the chief herbs. Trichosanthes kirilowii relieves chest congestion, clears phlegm, and relieves stagnation. Rehmannia glutinosa and Ophiopogon japonicus nourish yin, clear heat, and calm the mind. Together, these three herbs nourish yin, moisten dryness, resolve phlegm, and unblock the meridians, targeting the core pathogenesis of heart yin deficiency and phlegm-blood stasis. The assistant herbs are Codonopsis pilosula, Angelica sinensis, and Salvia miltiorrhiza. Codonopsis pilosula invigorates qi and strengthens the spleen, assisting the chief herbs in nourishing yin without hindering the spleen. Angelica sinensis and Salvia miltiorrhiza nourish blood, invigorate blood circulation, resolve stasis, and unblock the meridians. Together with the chief herbs, they promote qi and blood circulation, and resolve phlegm and blood stasis. The adjuvant herbs are Paeonia lactiflora and Rhodiola rosea. Paeonia lactiflora cools blood, invigorates blood circulation, disperses blood stasis, and relieves pain. Rhodiola rosea invigorates qi, invigorates blood circulation, unblocks the meridians, and relieves asthma. Together, they enhance the power of invigorating blood circulation and resolving blood stasis, and also clear away stagnant heat. The guiding herb is Achyranthes bidentata, which is aromatic and can regulate qi, harmonize the middle jiao, and invigorate the spleen and stomach. It can prevent the other herbs from being too rich and cloying and hindering the stomach, and can also guide the herbs to the heart meridian and harmonize the other herbs. The formula employs a rigorous combination of principal, assistant, and adjuvant herbs, nourishing Yin without accumulating pathogenic factors, resolving phlegm without harming the body's vital energy, and invigorating blood without depleting Qi. Each herb complements the others, working in synergy to achieve the effects of nourishing Yin, resolving phlegm, and invigorating blood circulation. It not only improves the underlying Yin deficiency but also addresses the symptoms of Qi stagnation, blood stasis, and malnourishment of the heart, thus achieving the overall therapeutic goals of nourishing Yin and generating fluids, invigorating blood circulation, soothing the liver and relieving depression, and calming the mind and relieving palpitations. The *Shennong Bencao Jing* describes Ophiopogon japonicus as sweet and slightly bitter, slightly cold in nature, and entering the lung, stomach, and heart meridians, "treating abdominal distension and stagnation." Modern pharmacological studies have found that Ophiopogon japonicus polysaccharides and total saponins can effectively prevent myocardial ischemia and inhibit inflammatory responses, making it one of the effective drugs for treating coronary heart disease. The assistant herbs in the formula include Salvia miltiorrhiza and Rhodiola rosea. Salvia miltiorrhiza, a commonly used drug for coronary heart disease, has the effects of invigorating blood and nourishing the heart, calming the mind and relieving anxiety. Furthermore, modern pharmacological studies have proven that Salvia miltiorrhiza has antioxidant, anti-aggregation, and vasodilatory effects. Rhodiola rosea not only nourishes and invigorates the blood, but also benefits qi and unblocks the meridians. For example, it can reduce nitric oxide and endothelin levels in vascular endothelial cells, improving posterior circulation blood supply. Large-plant Rhodiola rosea can lower serum low-density lipoprotein and increase high-density lipoprotein, while also effectively reducing blood viscosity, thus improving lipid metabolism and lowering hemorheological parameters. Studies have also shown that Rhodiola rosea has significant clinical effects in treating chronic myocardial infarction complicated with heart failure, effectively inhibiting left ventricular remodeling, reducing inflammation, and inhibiting atherosclerosis. These effects may have a dual regulatory role in angiogenesis in atherosclerosis and ischemic myocardium, as they can both stimulate myocardial angiogenesis to enhance cardiac function and inhibit angiogenesis in plaques to stabilize them. Lipwort, also known as Xinta Flower, is a traditional Xinjiang medicinal herb used in formulas as an adjuvant, possessing aromatic, purgative, anti-inflammatory, and regulatory effects. Studies have shown that *Pterocarya stenoptera* has a significant protective effect against acute and chronic myocardial ischemia. The water extract of *Pterocarya stenoptera* may improve atherosclerosis by regulating trimethylamine oxide (TMAO) levels, downregulating tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) levels, and reducing total cholesterol (TC) and triglyceride (TG) levels.When combined, these herbs work synergistically to nourish yin and moisten dryness, replenish qi and tonify deficiency, harmonize blood and unblock collaterals, and are remarkably effective in treating yin deficiency syndrome in coronary heart disease.

[0014] 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 good therapeutic effect on coronary heart disease with yin deficiency syndrome (including myocardial ischemia, angina pectoris, myocardial infarction, and ischemic heart disease). The mechanism of action is clear. It is a more precise solution that can nourish yin and clear heat, invigorate qi and promote blood circulation, and also take into account multiple symptoms such as chest pain, palpitations, insomnia, and fatigue. It can be standardized for the production of drugs and treatment of coronary heart disease with yin deficiency syndrome. At the same time, it can improve patients' clinical symptoms, improve patients' aquaporin levels and vascular endothelial function, and patients have not experienced adverse reactions such as liver and kidney damage or gastrointestinal discomfort. Detailed Implementation

[0015] 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 effort are all within the protection scope of the present invention.

[0016] This invention provides a traditional Chinese medicine composition for treating coronary heart disease, which is made from the following raw materials in parts by weight: Trichosanthes kirilowii 9-15 parts, Rehmannia glutinosa 9-15 parts, Ophiopogon japonicus 9-12 parts, Paeonia lactiflora 9-12 parts, Rhodiola rosea 9-15 parts, Codonopsis pilosula 6-9 parts, Angelica sinensis 6-9 parts, Salvia miltiorrhiza 9-15 parts, and Cirsium japonicum 6-9 parts.

[0017] The present invention relates to lip vanilla ( Ziziphora clinopodioides Lam. (This refers to the whole plant of *Lysimachia christinae*, a plant in the Lamiaceae family.) It is pungent and cool in nature. Its functions and indications include calming the mind and soothing the nerves; promoting diuresis and clearing heat. It is mainly distributed in Xinjiang, my country, and commonly grows on grasslands on low mountain slopes.

[0018] The other Chinese herbal raw materials are all commonly used in this field.

[0019] Example 1 A traditional Chinese medicine composition for treating coronary heart disease, which is made from the following raw materials: Trichosanthes kirilowii 15g, Rehmannia glutinosa 15g, Ophiopogon japonicus 12g, Paeonia lactiflora 9g, Rhodiola rosea 15g, Codonopsis pilosula 9g, Angelica sinensis 9g, Salvia miltiorrhiza 15g, and Citrus aurantium 6g.

[0020] Example 2 A traditional Chinese medicine composition for treating coronary heart disease, which is made from the following raw materials: Trichosanthes kirilowii 9g, Rehmannia glutinosa 9g, Ophiopogon japonicus 9g, Paeonia lactiflora 9g, Rhodiola rosea 9g, Codonopsis pilosula 6g, Angelica sinensis 6g, Salvia miltiorrhiza 9g, and Cirsium japonicum 6g.

[0021] Example 3 A traditional Chinese medicine composition for treating coronary heart disease, which is made from the following raw materials: Trichosanthes kirilowii 12g, Rehmannia glutinosa 12g, Ophiopogon japonicus 10g, Paeonia lactiflora 10g, Rhodiola rosea 12g, Codonopsis pilosula 8g, Angelica sinensis 8g, Salvia miltiorrhiza 12g, and Cirsium japonicum 8g.

[0022] Example 4 A traditional Chinese medicine composition for treating coronary heart disease, which is made from the following raw materials: Trichosanthes kirilowii 10g, Rehmannia glutinosa 12g, Ophiopogon japonicus 12g, Paeonia lactiflora 9g, Rhodiola rosea 9g, Codonopsis pilosula 8g, Angelica sinensis 9g, Salvia miltiorrhiza 10g, and Citrus aurantium 9g.

[0023] Example 5 A traditional Chinese medicine composition for treating coronary heart disease, which is made from the following raw materials: Trichosanthes kirilowii 15g, Rehmannia glutinosa 10g, Ophiopogon japonicus 9g, Paeonia lactiflora 12g, Rhodiola rosea 15g, Codonopsis pilosula 9g, Angelica sinensis 6g, Salvia miltiorrhiza 15g, and Cirsium japonicum 6g.

[0024] The traditional Chinese medicine compositions provided in Examples 1-5 above were all prepared according to the following steps: Combine the weighed medicinal materials, add water equivalent to 4 times 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 to the residue again, boil the liquid and simmer for 30 minutes, combine the two liquids and filter out the liquid to obtain the final product.

[0025] Example 6 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 20 minutes, boil the liquid and simmer for 60 minutes, filter out the liquid and keep it; add 2 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.

[0026] Since the traditional Chinese medicine compositions with the expected effects of the present invention were all prepared in Examples 1 to 6, and the effects of each example are similar, the following description of the effects of the present invention will only take Example 1 as an example.

[0027] 1. Clinical data and experimental methods The study included 132 cases diagnosed with coronary heart disease due to Yin deficiency syndrome in the Department of Cardiology, CCU, Cadre Ward, and Outpatient Department of Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital from June 2017 to December 2023. The cases were divided into two phases: 60 cases in the first phase and 72 cases in the second phase. A randomized controlled trial was conducted to illustrate the clinical effects of the drug by examining the differences before and after the phases.

[0028] 1.1 Diagnostic Criteria 1.1.1 Traditional Chinese Medicine Diagnosis The diagnostic criteria for chest pain in Traditional Chinese Medicine were formulated with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines" (revised by the State Drug Administration in 2002) and "Internal Medicine of Traditional Chinese Medicine" (edited by Zhou Zhongying).

[0029] Diagnostic criteria for angina pectoris: (1) chest tightness and pain, or even chest pain radiating to the back; (2) mild cases only feel chest tightness, shortness of breath, and difficulty breathing; (3) electrocardiogram and other examinations show ischemic changes or positive exercise test.

[0030] Diagnostic criteria for heart and kidney yin deficiency syndrome: Main symptom: Chest pain or chest tightness.

[0031] Secondary symptoms: palpitations, night sweats, restlessness and insomnia, lower back pain and weak knees, dizziness and tinnitus, dry mouth and constipation. Tongue and pulse: The tongue is red with little moisture, the coating is thin or peeled, and the pulse is thready and rapid or intermittent. If any two or more of the above symptoms are present, combined with the tongue and pulse, it can be diagnosed as a deficiency of Yin in the heart and kidneys.

[0032] 1.1.2 Western Medicine Diagnosis Western medical diagnostic criteria for coronary heart disease (CHD): Referencing the "Diagnostic Criteria for Coronary Atherosclerotic Heart Disease" issued by the Ministry of Health of the People's Republic of China in 2010; the clinical diagnostic criteria for CHD in the "Chinese Guidelines for the Prevention of Cardiovascular Diseases," confirmed by imaging and electrocardiogram examinations; the "Guidelines for the Diagnosis and Treatment of Chronic Stable Angina" issued by the Chinese Society of Cardiology in 2007; and the "Guidelines for the Diagnosis and Treatment of Unstable Angina and Non-ST-Segment Elevation Myocardial Infarction" and the "Guidelines for the Diagnosis and Treatment of Acute Myocardial Infarction" issued by the American College of Cardiology (ACC) / American Heart Association (AHA) in 2012. Coronary angiography or coronary CTA is one of the essential diagnostic criteria for CHD.

[0033] 1.2 Case Inclusion Criteria (1) Patients who meet the above diagnostic and syndrome differentiation criteria for coronary heart disease and chest pain (heart and kidney yin deficiency syndrome); (2) No other Chinese medicine has been taken in the past month; (3) Voluntary participation and obtaining informed consent, with good compliance; (4) Age between 18 and 80 years old, gender not limited.

[0034] 1.3 Case Exclusion Criteria (1) Patients with chest pain caused by other diseases other than coronary heart disease; (2) Patients with liver and kidney dysfunction (transaminase levels exceeding 1.5 times the normal reference value and / or serum creatinine exceeding 133 μmol / L), grade 3 hypertension (very high risk), severe heart failure, malignant arrhythmia, 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. (3) Pregnant or lactating women; (4) Individuals with allergic constitutions or allergies to any component of the test drug; 1.4 Case Exclusion Criteria (1) Those whose information is incomplete and whose treatment efficacy cannot be determined; (2) Those who naturally detached or were lost to follow-up during the experiment and were unable to complete the entire course of treatment; (3) Those who fail to take medication as prescribed or take other psychotropic drugs.

[0035] 1.5 Criteria for Terminating the Test (1) Those who experience severe adverse reactions and are unable to continue clinical research; (2) Those who develop serious complications in the heart, brain, kidneys, or other systems and require active rescue and treatment; (3) Those who request to withdraw from the experiment midway.

[0036] 2. Research Methods 2.1 Clinical Grouping This trial protocol used a randomized controlled trial (RCT) method to group patients. The RCT was established by the Department of Statistics at the Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University. Control group: Conventional Western medicine for coronary heart disease.

[0037] Treatment group: conventional Western medicine for coronary heart disease + the traditional Chinese medicine composition of Example 1 of this invention.

[0038] 2.2 Treatment Plan Control group: Bayer aspirin 100mg, once daily orally; atorvastatin calcium tablets 20mg, once daily orally before bedtime; isosorbide mononitrate 40mg, once daily orally; metoprolol 47.5mg, once daily orally.

[0039] Treatment group: Based on the control group, plus the traditional Chinese medicine composition of Example 1 of this invention (the medicine is from the Traditional Chinese Medicine Preparation Room of the Autonomous Region Traditional Chinese Medicine Hospital), one dose per day, divided into two doses, orally, for 4 weeks as one course of treatment.

[0040] 2.3 Observation Indicators The study observed changes in aquaporins (AQP-1, AQP-4), vascular endothelial status (ET-1, NO, vWF), the Seattle Heart Pain Scale, and TCM syndrome scores, TCM symptom scores, and angina symptom scores before and after treatment in both groups, based on the diagnostic criteria for "chest pain" in the textbook "Internal Medicine of Traditional Chinese Medicine" published by China Traditional Chinese Medicine Press. The results of the two groups were compared to observe whether the TCM combination therapy for Yin deficiency syndrome in coronary heart disease could improve clinical symptoms and enhance clinical efficacy.

[0041] 2.4 Criteria for Evaluating Therapeutic Effect (1) Criteria for judging the efficacy of TCM syndromes: Clinical cure: TCM clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%; Significant effect: Clinical symptoms and signs in TCM are significantly improved, and the syndrome score is reduced by ≥70% and <95%; Effective: Clinical symptoms and signs in Traditional Chinese Medicine showed significant improvement, with syndrome scores decreasing by ≥30% and <70%; Ineffective: No significant improvement in TCM clinical symptoms and signs, or even worsening of symptoms and signs, and a decrease in syndrome score of less than 30%; Calculation formula: [(Total score before treatment - Total score after treatment) ÷ Total score before treatment] * 100%; (2) Before and after treatment, 5 ml of fasting venous blood was drawn from both groups, and serum was separated by high-speed centrifugation. The levels of serum neurotransmitters AQP-1, AQP-4, ET-1, NO, and vWF were detected by enzyme-linked immunosorbent assay (ELISA).

[0042] 2.5 Safety Evaluation Indicators The patient's liver function, kidney function, blood routine, electrocardiogram and other indicators were tested before and after treatment to assess the drug's good safety and whether it caused any damage to liver and kidney function.

[0043] 3. Quality Control Enrollment was strictly conducted according to the above inclusion criteria. Patients were randomly coded by the Statistics Department of the Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital. Based on the randomization results, they were divided into the control group and the experimental group, and finally, case data were collected. During the study, patients signed informed consent forms, and detailed information was recorded. These records were checked by project team members to ensure the accuracy, completeness, and reliability of the data. Completed and standardized questionnaires were completed. Patients whose studies were terminated due to their own reasons or other reasons were removed according to the exclusion and termination criteria. All research data were accurately recorded and the statistical results were analyzed.

[0044] 4. Results Based on the clinical case collection and follow-up results, the remaining 126 patients were compared for efficacy, with 64 in the control group and 62 in the treatment group.

[0045] There was no statistically significant difference in the TCM syndrome scores between the two groups before treatment (P>0.05), indicating that the two groups were comparable. After treatment, the TCM syndrome scores of both groups decreased compared with those before treatment (P<0.05), and the improvement in the treatment group was more significant than that in the control group at the same time point (P<0.05), as shown in Tables 1-2.

[0046] Table 1. Comparison of control group before and after treatment (χ±S, score) Table 2 Comparison of treatment group before and after treatment (M(Q1,Q3)) Among the 126 patients compared, the clinical efficacy of the two groups after treatment was compared. The total effective rate of the treatment group was higher than that of the control group, indicating that the treatment group was superior to the control group (see Table 3).

[0047] Table 3 Comparison of clinical efficacy before and after treatment in the two groups Among the 126 patients compared, there was no statistically significant difference in the total angina score between the two groups before treatment (P>0.05), indicating that the two groups were comparable. After treatment, the total angina score of both groups decreased compared with that before treatment (P<0.05), and the improvement in the treatment group was more significant than that in the control group at the same time point (P<0.05), as shown in Table 4.

[0048] Table 4 Comparison of total angina scores before and after treatment in the two groups of patients Note: Compared with pre-treatment levels within the group. * P<0.05; compared with the control group at the same time point, ▲ P<0.05.

[0049] A comparison of 126 patients before and after treatment revealed no significant difference in the Seattle Scale scores between the two groups before treatment (P>0.05), indicating that the two groups were comparable. After treatment, there was a statistically significant difference in the Seattle Scale scores between the two groups (P<0.05), with the treatment group showing better scores than the control group (see Tables 6-7).

[0050] Table 6 Seattle Scale before and after treatment in both groups of patients Note: Compared with pre-treatment levels within the group. * P<0.05; compared with the control group at the same time point, ▲ P<0.05. PL: Degree of physical activity limitation, AS: Stable status of angina, AF: Frequency of angina attacks, TS: Treatment satisfaction, DS: Disease awareness.

[0051] Table 7 Comparison of the median Seattle Scale of Questionnaire (IQR) before and after treatment in the two groups Note: PL: Degree of physical activity limitation, AS: Stable angina status, AF: Angina attack frequency, TS: Treatment satisfaction, DS: Disease awareness level Before treatment, there were no statistically significant differences in AQP-1 and AQP-4 levels between the two groups (P > 0.05); after treatment, there were no statistically significant differences between the two groups (P > 0.05); after treatment, the concentrations of AQP-1 and AQP-4 in both groups were lower than before treatment (P < 0.05), and the concentrations in the treatment group were lower than those in the control group at the same time point (P < 0.05), as shown in Table 8.

[0052] Table 8 Comparison of aquaporins AQP-1 and AQP-4 (Unit: AU / mL) Note: *P<0.05 compared with pre-treatment levels within the group; ▲P<0.05 compared with the control group at the same time point.

[0053] There was no significant difference in nitric oxide (NO) levels between the two groups before treatment (P>0.05), indicating that the two groups were comparable. After treatment, both groups showed significant improvement in nitric oxide (NO) levels compared to before treatment (P<0.05) within each group, and the treatment group showed better results than the control group (P<0.05) between groups (Table 9). There was no statistically significant difference in ET-1 levels between the two groups before treatment (P>0.05); there was no statistically significant difference between the two groups after treatment (P>0.05); however, there were statistically significant differences before and after treatment in both the control group and the experimental group (P<0.05), indicating that the traditional Chinese medicine combination group was significantly better than the control group (Table 9).

[0054] Table 9 Comparison of vascular endothelial function indicators: NO (unit: μmol / L) and ET-1 (unit: pg / mL) After treatment, the vWF values ​​of both groups of patients decreased significantly compared with those before treatment, showing a statistically significant difference (P<0.05). However, when comparing the traditional Chinese medicine composition group and the control group, there was no statistically significant difference (P>0.05), as shown in Table 10.

[0055] Table 10 Comparison of vWF (unit: IU / mL) values ​​between the two groups of patients after treatment 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.

[0056] 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 Yin deficiency syndrome in coronary heart disease, characterized in that, It is made from the following raw materials by weight: Trichosanthes kirilowii 9-15 parts, Rehmannia glutinosa 9-15 parts, Ophiopogon japonicus 9-12 parts, Paeonia lactiflora 9-12 parts, Rhodiola rosea 9-15 parts, Codonopsis pilosula 6-9 parts, Angelica sinensis 6-9 parts, Salvia miltiorrhiza 9-15 parts, and Cirsium japonicum 6-9 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: 15 parts Trichosanthes kirilowii, 15 parts Rehmannia glutinosa, 12 parts Ophiopogon japonicus, 9 parts Paeonia lactiflora, 15 parts Rhodiola rosea, 9 parts Codonopsis pilosula, 9 parts Angelica sinensis, 15 parts Salvia miltiorrhiza, and 6 parts Citrus aurantium.

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: Trichosanthes kirilowii, Rehmannia glutinosa, Ophiopogon japonicus, Paeonia lactiflora, Rhodiola rosea, Codonopsis pilosula, Angelica sinensis, Salvia miltiorrhiza, and Cirsium japonicum. Mix the weighed herbs, soak them in water, decoct them, and collect the decoction 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 according to any one of claims 1 to 2 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 yin deficiency syndrome in coronary heart disease.

7. The application according to claim 5, characterized in that, The traditional Chinese medicine composition is used to prepare drugs for treating myocardial ischemia, angina pectoris, myocardial infarction, or ischemic heart disease.

8. A pharmaceutical preparation for treating coronary heart disease, characterized in that, It uses the traditional Chinese medicine composition described in any one of claims 1 to 2 as the sole effective ingredient.

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

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