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

Abstract

This invention relates to a traditional Chinese medicine composition for treating coronary heart disease and its preparation method, comprising the following raw materials in parts by weight: ginseng 3-18 parts, astragalus 6-30 parts, centella asiatica 6-30 parts, abscissus 6-30 parts, salvia miltiorrhiza 6-30 parts, chuanxiong rhizome 5-30 parts, safflower 5-20 parts, anemarrhena rhizome 6-30 parts, salvia miltiorrhiza seed 3-12 parts, prepared licorice root 3-12 parts, and stir-fried yam 5-30 parts. This composition can significantly improve cardiac function in rats with coronary heart disease, especially enhancing myocardial contractility; simultaneously, it can regulate lipid metabolism in model mice and reduce the formation of atherosclerotic plaques. Furthermore, in both of the aforementioned models, this composition can significantly reduce the expression levels of inflammatory factors such as interleukin-1β, interleukin-6, and tumor necrosis factor-α, thereby exerting an anti-inflammatory effect. In conclusion, this composition has promising application prospects in the prevention and treatment of coronary heart disease.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, and to a traditional Chinese medicine composition for treating coronary heart disease, particularly a traditional Chinese medicine composition for treating coronary heart disease and its preparation method. Background Technology

[0002] Coronary artery disease (CAD) is a major cardiovascular disease with leading morbidity and mortality rates worldwide, and its disease burden continues to increase. With the accelerating aging of the population and changes in lifestyle, the number of CAD patients is rising year by year, becoming one of the leading causes of death among Chinese residents. The occurrence and development of CAD is not only closely related to coronary atherosclerotic stenosis, but also involves multiple pathological mechanisms such as inflammatory responses, metabolic disorders, and neuroendocrine imbalances. Ultimately, it can progress to heart failure and even cardiac death, making it a chronic disease requiring long-term intervention and comprehensive management.

[0003] Current treatment strategies for coronary artery disease mainly include drug therapy and revascularization (such as percutaneous coronary intervention and coronary artery bypass grafting). Although these methods have achieved significant results in improving myocardial blood supply and alleviating symptoms, several unmet needs remain in clinical practice. First, atherosclerosis is progressive; even with intensive lipid-lowering and standardized treatment, some patients still have the risk of plaque instability, progression, or even rupture, indicating that current treatments are limited in stabilizing plaques and reversing lesions. Second, traditional revascularization methods are insufficient to effectively improve microcirculation perfusion, and existing drugs are relatively inadequate in intervening in microvascular function, leading to a continuous decline in cardiac function. In addition, the persistent activation of chronic inflammatory responses and metabolic abnormalities have not been fully and effectively controlled, and some patients still face a high risk of cardiovascular events even after receiving standardized treatment, necessitating the exploration of new intervention strategies.

[0004] In recent years, clinical trials and basic research have shown that traditional Chinese medicine (TCM) has the advantages of definite efficacy and fewer side effects in treating coronary heart disease. It can not only improve myocardial blood supply and stabilize atherosclerotic plaques, but also regulate metabolism and inhibit inflammatory responses, thus compensating for the shortcomings of Western medicine to a certain extent, forming a complementary effect and improving patient outcomes. Based on this background, this invention, starting from the clinical needs of coronary heart disease, proposes a TCM composition for treating coronary heart disease and its preparation method, providing a new treatment option for clinical practice. Summary of the Invention

[0005] To achieve the above objectives, this application provides a traditional Chinese medicine composition for treating coronary heart disease and its preparation method, offering a new option for clinical treatment. The specific technical solution is as follows:

[0006] The first objective of this invention is to provide a traditional Chinese medicine composition for treating coronary heart disease, which is made from the following raw materials in parts by weight: ginseng 3-18 parts, astragalus 6-30 parts, centella asiatica 6-30 parts, abrus australis 6-30 parts, salvia miltiorrhiza 6-30 parts, chuanxiong rhizome 5-30 parts, safflower 5-20 parts, anemarrhena rhizome 6-30 parts, salvia miltiorrhiza seed 3-12 parts, prepared licorice root 3-12 parts, and stir-fried yam 5-30 parts.

[0007] Furthermore, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9 parts ginseng, 15 parts astragalus, 15 parts centella asiatica, 15 parts chicken bone grass, 15 parts salvia miltiorrhiza, 10 parts chuanxiong rhizome, 10 parts safflower, 12 parts anemarrhena rhizome, 6 parts salvia miltiorrhiza, 6 parts prepared licorice root, and 15 parts stir-fried yam.

[0008] A second objective of this invention is to provide a method for preparing a traditional Chinese medicine composition for treating coronary heart disease, comprising the following steps:

[0009] Step 1: Weigh out each prepared Chinese medicinal herb according to the prescription ratio as raw material;

[0010] Step 2: Soak the herbs in 10-15 times their volume of water for 30-60 minutes, based on the amount of herbs taken in Step 1.

[0011] Step 3: Boil the soaked herbs twice, filter the liquids separately, and combine them.

[0012] Step 4: Concentrate the combined decoction to obtain a medicinal paste;

[0013] Step 5: Further process the obtained liquid ointment to prepare the desired dosage form.

[0014] Furthermore, in step 3, the decoction method is to first bring it to a boil over high heat, then simmer it over low heat for 60 minutes, and filter it to obtain the first decoction. After the decoction is completed, the liquid and the dregs are separated. The dregs are then added to 5-10 times the amount of water, brought to a boil over high heat, then simmered over low heat for 30 minutes, and filtered to obtain the second decoction. The filtered decoctions are then combined.

[0015] Furthermore, the further processing in step 5 includes: obtaining dry powder or extract powder by vacuum concentration, spray drying or freeze drying.

[0016] Furthermore, the dosage form of a traditional Chinese medicine composition for treating coronary heart disease includes: adding excipients and mixing, granulating or compressing to make granules or tablets, or filling powder or granules into empty capsules to prepare capsules, or sterilizing and dispensing clarified medicinal liquid to prepare oral liquid, or adding suitable binders to make water pills, honey pills or ointments.

[0017] Working principle of the invention:

[0018] Ginseng: This product is the dried root and rhizome of Panax ginseng (Panax ginseng CA Mey.), a plant belonging to the Araliaceae family. It is sweet, slightly bitter, and slightly warm in nature. It enters the spleen, lung, heart, and kidney meridians. It has the effects of greatly replenishing vital energy, restoring pulse and consolidating the body, tonifying the spleen and lungs, promoting body fluid production and nourishing blood, and calming the mind and improving intelligence. Modern pharmacological research shows that ginseng mainly contains ginsenosides (ginsenosides Rb1, Rg1, Rd, Re, etc.), polysaccharides, volatile oils, amino acids, and other components. Ginsenoside Rg1 can dilate coronary arteries, increase coronary blood flow, and reduce myocardial oxygen consumption, exhibiting anti-myocardial ischemia and anti-arrhythmic effects; ginsenoside Rd can inhibit platelet aggregation, reduce blood viscosity, and improve microcirculation disorders; ginseng polysaccharides can regulate lipid metabolism, reduce serum total cholesterol and low-density lipoprotein cholesterol levels, and inhibit the formation of atherosclerotic plaques.

[0019] Astragalus: This product is the dried root of *Astragalus membranaceus* (Fisch.) Bge. var. *mongholicus* (Bge.) Hsiao or *Astragalus membranaceus* (Fisch.) Bge. (Fabaceae family). It is sweet and slightly warm in nature. It enters the spleen and lung meridians. It has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting pus drainage and detoxification, and astringing sores and promoting tissue regeneration. Modern pharmacological studies have shown that astragalus mainly contains astragaloside IV, astragalus polysaccharides, flavonoids (verrucoside, gentianin), amino acids, and other components. Astragaloside A can enhance myocardial contractility, improve cardiac pumping function, reduce myocardial hypertrophy, and inhibit myocardial fibrosis; Astragalus polysaccharides have significant antioxidant stress effects, scavenge oxygen free radicals, and protect the ultrastructure of myocardial cells; Astragalus flavonoids can dilate coronary arteries, increase coronary blood flow, improve myocardial blood supply, and also have anti-inflammatory effects, inhibiting the inflammatory response of atherosclerosis; Astragaloside A and Astragalus polysaccharides work synergistically to regulate immune function, inhibit excessive inflammatory response, reduce inflammatory cell infiltration in myocardial tissue, and protect ischemic myocardium.

[0020] Centella asiatica: This product is the dried whole herb of Centella asiatica (L.) Urb., a plant of the Apiaceae family. It is bitter, pungent, and cold in nature. It enters the liver, spleen, and kidney meridians. It has the effects of clearing heat and dampness, detoxifying, and reducing swelling. Modern pharmacological studies have shown that Centella asiatica mainly contains triterpenoid saponins (asiaticoside, asiaticoside, asiatic acid, asiaticoside), polyacetylenes, flavonoids, and other components. Asiaticoside can promote collagen synthesis, improve microcirculation, enhance capillary toughness, and reduce myocardial edema; asiaticoside has significant antioxidant activity, scavenging oxygen free radicals, inhibiting lipid peroxidation, and protecting the integrity of myocardial cell membranes; total asiaticosides can inhibit the release of inflammatory factors, reduce myocardial inflammation, and inhibit the process of myocardial fibrosis.

[0021] Chicken Bone Grass: This product is the dried whole plant of *Abrus cantoniensis* Hance, a legume. It is sweet, slightly bitter, and cool in nature. It enters the liver and stomach meridians. It has the effects of promoting diuresis and relieving jaundice, clearing heat and detoxifying, and soothing the liver and relieving pain. Modern pharmacological studies have shown that Chicken Bone Grass mainly contains flavonoids (Abrus cantoniensis flavonoids and Chicken Bone Grass flavonoids), triterpenoid saponins, alkaloids, polysaccharides, and other components. Total flavonoids of Chicken Bone Grass have significant hepatoprotective and enzyme-lowering effects, improve liver metabolic function, indirectly regulate lipid metabolism, reduce serum triglyceride and low-density lipoprotein cholesterol levels, and have a lipid-lowering and weight-loss effect on hyperlipidemic mice. Chicken Bone Grass extract can inhibit the release of inflammatory factors, alleviate systemic chronic inflammation, and improve vascular endothelial function. Chicken Bone Grass polysaccharides have antioxidant activity, scavenge oxygen free radicals, inhibit lipid peroxidation, and protect the cardiovascular system. The triterpenoid saponins in Chicken Bone Grass can inhibit the release of platelet-activating factor, reduce platelet aggregation rate, and prevent thrombosis.

[0022] Danshen: This product is the dried root and rhizome of *Salvia miltiorrhiza* Bge., a plant belonging to the Lamiaceae family. It is bitter and slightly cold in nature. It enters the Heart and Liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling. Modern pharmacological studies have shown that Danshen mainly contains fat-soluble tanshinones (tanshinone I, IIA, IIB, cryptotanshinone, etc.) and water-soluble phenolic acids (tanshinone B, tanshinone A, rosmarinic acid, protocatechuic aldehyde, etc.). Tanshinone IIA can dilate coronary arteries, increase coronary blood flow, improve myocardial blood supply, and has a significant anti-myocardial ischemia effect; Tanshinone B has strong antioxidant activity, scavenges oxygen free radicals, inhibits lipid peroxidation, protects ischemic cardiomyocytes, and reduces myocardial ischemia-reperfusion injury; Tanshinone B and Tanshinone IIA work synergistically to inhibit myocardial fibrosis, reduce ventricular remodeling after myocardial infarction, and improve cardiac function; Tanshinone extract can regulate lipid metabolism, reduce serum total cholesterol and triglyceride levels, and inhibit low-density lipoprotein oxidative modification.

[0023] Chuanxiong (Ligusticum chuanxiong Hort.): This product is the dried rhizome of the plant Ligusticum chuanxiong Hort., belonging to the Apiaceae family. It is pungent and warm in nature. It enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting blood circulation, regulating qi, dispelling wind, and relieving pain. Modern pharmacological studies have shown that Chuanxiong mainly contains phthalides (ligustrazine, ferulic acid, ligustrazine lactone, etc.), alkaloids, and volatile oils. Ligustrazine can dilate coronary arteries, increase coronary blood flow, improve myocardial blood supply, and simultaneously dilate cerebral blood vessels, improving cerebral circulation; ligustrazine can inhibit platelet aggregation, reduce platelet activation rate, prevent thrombosis, and improve hypercoagulable states; ferulic acid has significant antioxidant activity, scavenging oxygen free radicals, inhibiting lipid peroxidation, and protecting vascular endothelial cells.

[0024] Safflower: This product is the dried flower of *Carthamus tinctorius* L., a plant in the Asteraceae family. It is pungent and warm in nature, and enters the heart and liver meridians. It has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain. Modern pharmacological studies have shown that safflower mainly contains flavonoids (safflower yellow pigment, hydroxysafflower yellow pigment A, safflower glycosides, etc.), alkaloids, polysaccharides, and fatty acids. Hydroxysafflower yellow pigment A can improve microcirculation, increase the number of open capillaries, improve tissue blood perfusion, and reduce myocardial ischemia and hypoxia; safflower yellow pigment can dilate coronary arteries, increase coronary blood flow, improve myocardial blood supply, and reduce the degree of myocardial ischemia; total safflower flavonoids have strong antioxidant activity, scavenge oxygen free radicals, inhibit lipid peroxidation, and protect ischemic myocardial cells; safflower polysaccharides can enhance immune function, regulate inflammatory responses, and inhibit excessive inflammation from damaging myocardial tissue; safflower extract can lower serum total cholesterol and low-density lipoprotein cholesterol levels, inhibit the formation of atherosclerotic plaques, and stabilize plaque structure.

[0025] Anemarrhena asphodeloides Bge., a plant of the Liliaceae family, is a dried rhizome. It is bitter, sweet, and cold in nature. It enters the lung, stomach, and kidney meridians. It has the effects of clearing heat and purging fire, nourishing yin and moistening dryness. Modern pharmacological studies have shown that Anemarrhena asphodeloides mainly contains steroidal saponins (such as anemarrhena saponins AIII, BII, and BIII), flavonoids, polysaccharides, and alkaloids. Anemarrhena saponin AIII has significant anti-inflammatory effects, reducing myocardial inflammation and inhibiting the infiltration of inflammatory cells in atherosclerotic plaques; anemarrhena saponin BII can inhibit abnormal proliferation of vascular smooth muscle cells, reduce vascular intimal hyperplasia, and prevent restenosis; total anemarrhena saponins can lower blood lipid levels, inhibit cholesterol absorption, reduce lipid deposition in the vascular wall, and delay the progression of atherosclerosis; anemarrhena polysaccharides have antioxidant activity, scavenging oxygen free radicals and reducing oxidative stress damage to myocardial cells.

[0026] *Aesculus chinensis* seeds: This product is the dried, mature seed of *Aesculus chinensis* Bge., *Aesculus chinensis* var. *chekiangensis* (Hu et Fang) Fang, or *Aesculus wilsonii* Rehd., all belonging to the Horse Chestnut family. It is sweet and warm in nature. It enters the Liver and Stomach meridians. It has the effects of soothing the Liver and regulating Qi, harmonizing the Stomach and relieving pain. Modern pharmacological studies have shown that *Aesculus chinensis* seeds mainly contain triterpenoid saponins (aescinoside, isoescinoside), flavonoids, coumarins, and fatty oils. Aesscinoside has multiple cardiovascular protective effects, which can reduce myocardial inflammation and inhibit the process of myocardial fibrosis by inhibiting the release of inflammatory mediators; at the same time, it can inhibit platelet aggregation, reduce blood viscosity, and improve blood rheological properties, thereby preventing microthrombus formation. In addition, aesscinoside also has antioxidant activity, which can scavenge oxygen free radicals and reduce the damage of oxidative stress to vascular endothelial cells. Based on this, sodium aescinate further enhances myocardial protection by improving microcirculation, regulating capillary permeability, promoting tissue edema reduction, and alleviating myocardial tissue edema, thus exerting a synergistic effect on multiple aspects such as inflammation, blood rheology, and microcirculation.

[0027] Prepared licorice root: This product is a processed product of the dried roots and rhizomes of the legumes *Glycyrrhiza uralensis* Fisch., *Glycyrrhiza inflata* Batal., or *Glycyrrhiza glabra* L. It is sweet and neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and stomach, replenishing qi, and restoring pulse. Modern pharmacological studies have shown that prepared licorice root mainly contains triterpenoid saponins (glycyrrhizic acid, glycyrrhetinic acid), flavonoids (glycyrrhizin, isoglycyrrhizin), polysaccharides, alkaloids, and other components. Glycyrrhizic acid has significant anti-inflammatory effects, inhibiting the release of inflammatory factors, reducing myocardial inflammation, and inhibiting myocardial fibrosis. Total flavonoids of licorice have antioxidant activity, scavenging oxygen free radicals and reducing the damage of oxidative stress to myocardial cells. Licorice polysaccharides can enhance myocardial contractility, improve cardiac function, and also have immunomodulatory effects. The synergistic effect of glycyrrhizic acid and glycyrrhetinic acid can regulate lipid metabolism, reduce serum cholesterol levels, and inhibit the progression of atherosclerosis.

[0028] Fried Yam: This product is a processed product of the dried rhizome of Dioscorea opposita Thunb., a plant of the Dioscoreaceae family. It is sweet and neutral in nature. It enters the spleen, lung, and kidney meridians. It has the effects of tonifying the spleen and stomach, promoting body fluid production and benefiting the lungs, and tonifying the kidneys and astringing essence. Modern pharmacological studies have shown that fried yam mainly contains polysaccharides (yam polysaccharides), diosgenin, flavonoids, allantoin, amino acids, and other components. Yam polysaccharides have significant antioxidant activity, scavenging oxygen free radicals, inhibiting lipid peroxidation, protecting the integrity of myocardial cell membranes, and reducing myocardial ischemia-reperfusion injury. Diosgenin can lower blood lipid levels, inhibit cholesterol absorption, reduce lipid deposition on the vascular wall, and delay the progression of atherosclerosis. Simultaneously, diosgenin has a mild hypotensive effect, can dilate peripheral blood vessels, and reduce cardiac afterload. In addition, diosgenin improves insulin resistance, regulates glucose and lipid metabolism, and reduces the damage of metabolic syndrome to the cardiovascular system.

[0029] Patients with coronary heart disease often suffer from qi deficiency and impaired digestion due to multiple factors. Coupled with the rich and greasy diet of modern society, sedentary lifestyle, and emotional imbalance, phlegm and dampness often accumulate internally, causing stagnation of qi. The accumulation of dampness and turbidity obstructs the yang in the chest, and the stagnation of qi leads to poor blood circulation. This results in blood stasis and internal heat generation, forming a complex pathogenesis with qi deficiency as the root cause and the mutual binding of phlegm and dampness, qi stagnation, blood stasis, and heat. This is the important theoretical basis for the formulation and combination of this formula.

[0030] Ginseng and astragalus are the principal herbs, working synergistically to greatly replenish heart qi and strengthen the spleen. When the spleen and stomach function properly, phlegm and dampness cannot be generated, and when heart qi is sufficient, blood is effectively guided. This approach addresses the root cause of phlegm and dampness formation and promotes blood circulation, thus focusing on the fundamental pathogenesis of modern coronary heart disease caused by qi deficiency and phlegm-dampness.

[0031] Centella asiatica, Abrus precatorius, Salvia miltiorrhiza, and Ligusticum chuanxiong are the assistant herbs. Centella asiatica effectively clears dampness and stagnation in the collaterals, resolves latent heat and stagnation, and breaks up the sticky and viscous state of phlegm-dampness and blood stasis. Abrus precatorius soothes the liver and promotes diuresis, clears heat and harmonizes the collaterals, clears phlegm-dampness and turbidity in the chest and diaphragm and throughout the body, and promotes the flow of qi, preventing dampness and turbidity from obstructing the heart vessels. Salvia miltiorrhiza invigorates blood, removes blood stasis, relieves pain, and calms the mind, specifically targeting the heart meridian to disperse stagnation and unblock the meridians. Ligusticum chuanxiong promotes qi and blood circulation, disperses stagnation and unblocks the collaterals, and raises clear yang, dispelling chest tightness and distending pain caused by phlegm-dampness stagnation. The four herbs combined invigorate blood and qi, promote diuresis and eliminate turbidity, clear heat and stagnation, and clear the heart collaterals, directly addressing the core problem of phlegm-dampness obstruction and the mutual binding of dampness and stagnation.

[0032] Safflower, Anemarrhena asphodeloides, and Salvia miltiorrhiza are used as adjuvant herbs. Safflower breaks up blood stasis, unblocks meridians, disperses nodules, and relieves pain; Anemarrhena asphodeloides nourishes yin, clears heat, moistens dryness, and reduces fire, clearing internal heat caused by long-term stagnation of phlegm and dampness, while restraining the warming and drying properties of ginseng and astragalus, preventing the generation of dampness and heat and the depletion of heart yin; Salvia miltiorrhiza promotes qi circulation, disperses stagnation, relieves chest tightness and dissipates nodules, and alleviates qi stagnation caused by emotional distress. When qi flows smoothly, dampness and blood stasis are easily transformed. The combination of these adjuvant herbs assists the principal and assistant herbs in drying dampness, regulating the spleen, clearing heat, dispersing stagnation, and resolving blood stasis and unblocking meridians, comprehensively resolving the problems of phlegm-dampness, qi stagnation, stagnant heat, and blood stasis.

[0033] Prepared licorice root and stir-fried yam are used as guiding herbs to strengthen the spleen and stomach, replenish qi and regulate the middle jiao, and harmonize the properties of other herbs. They strengthen the acquired function of the spleen and stomach in digestion and transformation, enhance the body's ability to transport and transform water and dampness and metabolize phlegm, so that dampness is removed without harming the spleen and tonifying without promoting dampness, and harmonize the properties of various herbs in the formula that replenish qi, invigorate blood, eliminate dampness, clear heat, and promote qi circulation.

[0034] In summary, the eleven herbs work synergistically, nourishing without causing stagnation, invigorating without harming, clearing without being cold, dispersing while astringing, regulating both qi and blood, and addressing both the root cause and the symptoms. The entire formula is based on the common characteristics of phlegm-dampness accumulation and dampness-blood stasis in modern coronary heart disease. It tonifies qi and strengthens the body's foundation to eliminate the source of phlegm-dampness, promotes diuresis and eliminates turbidity, regulates qi and relieves stagnation, and invigorates blood and removes blood stasis to eliminate the excess of phlegm-dampness, blood stasis, and heat. This approach treats both the root cause and the symptoms, aligning with the complex pathogenesis of contemporary coronary heart disease.

[0035] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0036] Firstly, the herbal composition of this invention does not have a completely corresponding formula. Although its formulation concept is similar to other qi-tonifying and blood-activating formulas, this invention has the following advantages:

[0037] 1. The combination of Centella asiatica and Abrus precatorius is one of the important innovations of this formula. The two complement each other, further enhancing the effects of clearing heat and promoting diuresis on the basis of invigorating qi and promoting blood circulation. This combination makes up for the limitations of traditional qi-invigorating and blood-activating formulas, which tend to focus on tonifying deficiency and promoting blood circulation, but do not pay enough attention to damp-heat factors. This improves the adaptability to complex syndromes and is more in line with the pathological state of modern coronary heart disease patients.

[0038] 2. The addition of Salvia miltiorrhiza is another key innovation of this formula. When used in combination with Centella asiatica and Abrus precatorius, the three herbs work synergistically to: 1) soothe the liver and gallbladder, eliminating the source of dampness; and 2) harmonize the stomach and regulate the middle jiao, facilitating the movement of water and dampness, thus forming a beneficial regulatory mechanism of "when the liver is soothed, the stomach is harmonious; when the stomach is harmonious, dampness is eliminated." Simultaneously, the qi-regulating and pain-relieving properties of Salvia miltiorrhiza can synergistically enhance the qi and blood circulation effects of blood-activating herbs, making the flow of qi, blood, and water more coordinated.

[0039] 3. The composition of this invention not only improves ventricular remodeling caused by myocardial ischemia, but also slows down the pathological process of coronary heart disease by regulating lipid metabolism and inhibiting the formation and progression of atherosclerotic plaques. It also embodies the medical concept of "prevention before disease occurs and prevention of disease progression." Animal experimental results show that the traditional Chinese medicine composition provided by this invention can improve cardiac contractile function in rats with ischemic heart failure. Simultaneously, this traditional Chinese medicine composition can significantly reduce plaque burden and improve blood lipid levels in mice with atherosclerosis. Furthermore, this composition can significantly downregulate the expression levels of inflammatory factors such as interleukin-1β, interleukin-6, and tumor necrosis factor-α, thereby exerting a good anti-inflammatory effect.

[0040] 4. When Centella asiatica, Abrus precatorius, and Salvia miltiorrhiza are removed from the traditional Chinese medicine composition of the present invention, the regulatory effect of the new traditional Chinese medicine composition on blood lipid levels, N-terminal pro-B-type natriuretic peptide levels, and inflammatory factors is significantly weakened. Attached Figure Description

[0041] Figure 1 The results are shown in the echocardiographic images of rats; (A) representative echocardiographic images of each group; (B) changes in left ventricular ejection fraction in each group; (C) changes in left ventricular shortening fraction in each group. Compared with the control group, <0.001, compared to the model group, <0.05; <0.01.

[0042] Figure 2 Results of atherosclerotic plaques and lipid levels in mice; including: (A) Oil Red O staining of the aortic root in each group; (B) Percentage of aortic root plaque area in each group; (C) Triglyceride levels in each group; (D) Total cholesterol levels in each group; (E) Low-density lipoprotein cholesterol levels in each group; (F) High-density lipoprotein cholesterol levels in each group. Compared with the control group, <0.001, compared to the model group, <0.05; <0.001.

[0043] Figure 3 The results of serum inflammatory factor detection in rats and mice are as follows: (A) Interleukin-1β level in each group; (B) Interleukin-6 level in each group; (C) Tumor necrosis factor-α level in each group; (D) Interleukin-1β level in each group; (E) Interleukin-6 level in each group; (F) Tumor necrosis factor-α level in each group. Compared with the control group, <0.001, compared to the model group, <0.05; <0.001.

[0044] Figure 4 The results show the liver and kidney function of rats and mice; where: (A) is the alanine aminotransferase (ALT) level of each rat group, (B) is the aspartate aminotransferase (AST) level of each rat group, (C) is the serum creatinine level of each rat group, (D) is the serum urea level of each group, (E) is the ALT level of each mouse group, (F) is the AST level of each mouse group, (G) is the serum creatinine level of each mouse group, and (H) is the serum urea level of each mouse group.

[0045] Figure 5To investigate the regulatory effects of removing Centella asiatica, Abrus precatorius, and Salvia miltiorrhiza on coronary heart disease; the following were measured: (A) N-terminal pro-B-type natriuretic peptide levels in rats; (B) Percentage of aortic root plaque area in mice; (C) Triglyceride levels in mice; (D) Total cholesterol levels in mice; (E) Low-density lipoprotein cholesterol levels in mice; (F) High-density lipoprotein cholesterol levels in mice; (G) Interleukin-1β levels in rats; (H) Interleukin-6 levels in rats; (I) Tumor necrosis factor-α levels in rats; (J) Interleukin-1β levels in mice; (K) Interleukin-6 levels in mice; (L) Tumor necrosis factor-α levels in mice. Compared with the control group, <0.001, compared to the model group, <0.05; <0.001, compared with the composition without Centella asiatica, Abrus precatorius, and Salvia miltiorrhiza, ++P<0.01;+++P<0.001. Detailed Implementation

[0046] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings.

[0047] Example 1: A method for preparing a traditional Chinese medicine composition for treating coronary heart disease, comprising the following steps: 9 parts ginseng, 15 parts astragalus, 15 parts centella asiatica, 15 parts chicken bone grass, 15 parts salvia miltiorrhiza, 10 parts chuanxiong rhizome, 10 parts safflower, 12 parts anemarrhena rhizome, 6 parts salvia miltiorrhiza, 6 parts prepared licorice root, and 15 parts stir-fried yam are soaked in 1300ml of water for 30 minutes; after boiling over high heat, the mixture is simmered over low heat for 60 minutes, and filtered to obtain the first decoction; after decoction, the liquid and dregs are separated, and 700ml of water is added to the dregs, and the mixture is boiled over high heat and simmered over low heat for 30 minutes, and filtered to obtain the second decoction; the filtrates are combined and concentrated into the corresponding extract; conventional excipients for granulation are added to the obtained extract, mixed well, granulated according to conventional methods, and dried and sized to obtain granules.

[0048] Example 2: A method for preparing a traditional Chinese medicine composition for treating coronary heart disease, comprising the following steps: 3 parts ginseng, 6 parts astragalus, 6 parts centella asiatica, 6 parts chicken bone grass, 6 parts salvia miltiorrhiza, 5 parts chuanxiong rhizome, 5 parts safflower, 6 parts anemarrhena rhizome, 3 parts salvia miltiorrhiza, 3 parts prepared licorice root, and 5 parts stir-fried yam are soaked in 550ml of water for 30 minutes; after boiling over high heat, the mixture is simmered over low heat for 60 minutes, and filtered to obtain the first decoction; after decoction, the liquid and dregs are separated, and 300ml of water is added to the dregs, and the mixture is boiled over high heat and simmered over low heat for 30 minutes, and filtered to obtain the second decoction; the filtrates are combined and concentrated into the corresponding extract; conventional excipients for granulation are added to the obtained extract, mixed well, granulated according to conventional methods, and dried and sized to obtain granules.

[0049] Example 3: A method for preparing a traditional Chinese medicine composition for treating coronary heart disease, comprising the following steps: 18 parts ginseng, 30 parts astragalus, 30 parts centella asiatica, 30 parts chicken bone grass, 30 parts salvia miltiorrhiza, 20 parts chuanxiong, 20 parts safflower, 30 parts anemarrhena asphodeloides, 12 parts salvia miltiorrhiza, 12 parts roasted licorice root, and 30 parts stir-fried yam are soaked in 2700ml of water for 30 minutes; after boiling over high heat, the mixture is simmered over low heat for 60 minutes, and filtered to obtain the first decoction; after decoction, the liquid and dregs are separated, and 1400ml of water is added to the dregs, and the mixture is boiled over high heat and simmered over low heat for 30 minutes, and filtered to obtain the second decoction; the filtrates are combined and concentrated into the corresponding extract; conventional excipients for granulation are added to the obtained extract, mixed well, granulated according to conventional methods, and dried and sized to obtain granules.

[0050] Experimental Example 1: Animal Pharmacology Experiment (using the drug composition of Example 1)

[0051] 1. Materials and Methods

[0052] Animal studies using the traditional Chinese medicine composition of Example 1

[0053] Sixty specific pathogen-free male SD rats (6–8 weeks old, weighing 200 ± 20 g) were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. The rats were given a standard synthetic diet and purified water on an ad libitum basis. The housing conditions were: temperature (24℃ ± 2℃), humidity (45%–50%), and 12-hour light / dark cycle. A rat model of myocardial infarction was established by ligation of the left anterior descending artery by skilled personnel. The model rats were randomly divided into six groups using a random number table: sham-operated group, model group, low-dose group of traditional Chinese medicine composition (6 g / kg / d), medium-dose group of traditional Chinese medicine composition (12 g / kg / d), high-dose group of traditional Chinese medicine composition (24 g / kg / d), and enalapril group (0.45 mg / kg / d). Treatment continued for 28 days. Animal dosages were converted to human dosages based on body surface area and weight. Rats in the sham-operated group and model group were administered an equal volume of physiological saline by gavage.

[0054] Specific pathogen-free males Fifty mice (6–8 weeks old) were fed a high-fat diet for 8 weeks after one week of normal feeding to induce an atherosclerosis model. The mice were randomly divided into five groups: model group, low-dose group of the traditional Chinese medicine composition (12.5 g / kg / d), medium-dose group of the traditional Chinese medicine composition (25 g / kg / d), high-dose group of the traditional Chinese medicine composition (50 g / kg / d), and atorvastatin calcium group (4 mg / kg / d). Treatment continued for 8 weeks. Ten C57BL / 6J mice served as a normal control group, receiving a normal diet. Both the control and model groups were administered an equal volume of physiological saline by gavage.

[0055] 2. Echocardiography

[0056] After anesthetizing the rats, cardiac function was assessed using two-dimensional and M-mode echocardiography by researchers unaware of their grouping status. The results are as follows: Figure 1 As shown:

[0057] Figure 1 A (Echocardiography): In the sham surgery group, the ventricular structure was intact, the myocardial contraction rhythm was uniform, and the ventricular wall motion was coordinated; in the model group, the left ventricle was significantly dilated, the ventricular wall motion was weakened, and the contraction amplitude was reduced, indicating significant impairment of cardiac function; the myocardial waveforms of the different doses of traditional Chinese medicine treatment groups and the enalapril group gradually improved compared with the model group.

[0058] Figure 1 B (Left ventricular ejection fraction): The left ventricular ejection fraction in the model group was significantly lower than that in the sham surgery group. This indicates a highly significant difference compared to the sham surgery group; the increase in left ventricular ejection fraction in the medium-dose and high-dose groups was significantly greater than that in the model group. (Indicates a significant or relatively significant difference compared to the model group), indicating that the treatment can improve left ventricular ejection function.

[0059] Figure 1 C (short axis shortening rate): The short axis shortening rate in the model group was significantly lower than that in the sham surgery group. (# indicates a highly significant difference compared to the sham surgery group); the short-axis shortening rate of medium and high doses was significantly higher than that of the model group (# and ## indicate significant or relatively significant differences compared to the model group).

[0060] In summary, the above results indicate that the model group successfully constructed a model of cardiac function impairment, and treatment with different doses of traditional Chinese medicine composition (especially medium and high doses) can improve myocardial motor function, increase left ventricular ejection fraction and fractional shortening, thereby improving cardiac function and enhancing cardiac contractile function.

[0061] 3. Atherosclerosis and blood lipid testing

[0062] After the experiment, aortic root tissue from mice was collected for Oil Red O staining analysis. Blood samples were collected from mice under anesthesia using the orbital blood sampling method. After standing at room temperature for 1 hour, the samples were centrifuged at 3000 rpm for 10 minutes at 4 °C to separate serum. Following the kit instructions, enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of lipid-related indicators in the serum. Results are as follows: Figure 2 As shown:

[0063] Figure 2 A (Oil Red O staining of aortic root in each group): ApoE⁻ / ⁻ mouse model group showed obvious lipid deposition in aortic root, and the area of ​​Oil Red O staining positive area increased significantly; the staining area of ​​each dose group of traditional Chinese medicine and atorvastatin calcium group was significantly reduced.

[0064] Figure 2B (Aortic root plaque area in each group): The aortic root plaque area in the model group was significantly higher than that in the control group. (### indicates a highly significant difference compared to the control group), and the effect of traditional Chinese medicine treatment was significantly reduced (### indicates a highly significant difference compared to the model group).

[0065] Figure 2 CF (lipid levels in each group): Compared with the control group, the model group had significantly higher levels of triglycerides, total cholesterol, and low-density lipoprotein cholesterol, and lower levels of high-density lipoprotein cholesterol. The numbers indicate a highly significant difference compared to the control group; all dosage groups of traditional Chinese medicine can improve dyslipidemia to varying degrees (#, ### indicate significant or highly significant differences compared to the model group), with the medium and high dosage groups showing more significant effects.

[0066] In summary, the above results indicate that the model group successfully constructed a model of arteriosclerosis, and that treatment with different doses of traditional Chinese medicine composition (especially medium and high doses) can delay arteriosclerosis and regulate blood lipids.

[0067] 4. Inflammatory factor detection

[0068] Figure 3 A (Rat interleukin-1β level): Interleukin-1β level was significantly increased in the model group ( (### indicates a highly significant difference compared to the sham surgery group); the levels of interleukin-1β in different doses of traditional Chinese medicine and enalapril groups were significantly lower than those in the model group (### indicates a highly significant difference compared to the model group).

[0069] Figure 3 B (Rat interleukin-6 level): Interleukin-6 level was significantly increased in the model group ( (### indicates a highly significant difference compared to the sham surgery group); the levels of interleukin-6 in the different doses of traditional Chinese medicine and the enalapril group were lower than those in the model group (### indicates a highly significant difference compared to the model group).

[0070] Figure 3 C (Rat tumor necrosis factor-α level): The tumor necrosis factor-α level in the model group was significantly increased ( (### indicates a highly significant difference compared to the sham surgery group); the levels of tumor necrosis factor-α in the different doses of traditional Chinese medicine and the enalapril group were lower than those in the model group (### indicates a highly significant difference compared to the model group).

[0071] Figure 3 D (mice interleukin-1β level): Interleukin-1β levels were significantly elevated in the model group ( (### indicates a highly significant difference compared to the control group); the levels of interleukin-1β in different doses of traditional Chinese medicine and atorvastatin calcium groups were significantly lower than those in the model group (### indicates a highly significant difference compared to the model group).

[0072] Figure 3 E (mice interleukin-6 levels): Interleukin-6 levels were significantly elevated in the model group ( (### indicates a highly significant difference compared to the control group); the levels of interleukin-6 in the different doses of traditional Chinese medicine and the atorvastatin calcium group were lower than those in the model group (### indicates a highly significant difference compared to the model group).

[0073] Figure 3 F (mice tumor necrosis factor-α level): The tumor necrosis factor-α level in the model group was significantly increased ( (# indicates a highly significant difference compared to the control group); the levels of tumor necrosis factor-α in the different doses of traditional Chinese medicine and the atorvastatin calcium group were lower than those in the model group (#, ### indicate significant or highly significant differences compared to the model group).

[0074] In summary, the above results indicate that, compared with the control group, the levels of inflammatory markers (interleukin-1β, interleukin-6, and tumor necrosis factor-α) were significantly increased in both the model group rats and mice. Furthermore, different doses of treatment (especially medium and high doses) could significantly inhibit the expression of inflammatory factors and alleviate the inflammatory response.

[0075] 5. Safety Indicators

[0076] After appropriate treatment of each group of experimental animals, blood samples were collected. Then, biochemical detection methods were used to detect the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine, and urea in the blood.

[0077] The results are as follows Figure 4 The results of liver and kidney function tests showed that, throughout the experiment, no differences in liver function indicators or kidney function indicators were found between the different doses of the traditional Chinese medicine composition and the control group, indicating that the traditional Chinese medicine composition of the present invention is safe.

[0078] 6. To highlight the effects of Centella asiatica, Abrus precatorius, and Salvia miltiorrhiza in the traditional Chinese medicine composition of this invention on the regulation of coronary heart disease, this invention also includes a variable experiment. The composition after removing Centella asiatica, Abrus precatorius, and Salvia miltiorrhiza was used in an animal model to verify the difference in its regulatory effect on coronary heart disease compared to the composition of this invention. The results are as follows: Figure 5 As shown, when Centella asiatica, Abrus precatorius, and Salvia miltiorrhiza are removed from the traditional Chinese medicine composition of the present invention, the regulatory effects of the traditional Chinese medicine composition on heart failure markers (N-terminal pro-B-type natriuretic peptide), blood lipids (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol), and inflammatory factors (interleukin-1β, interleukin-6, and tumor necrosis factor-α levels) are significantly weakened, indicating that the efficacy of the traditional Chinese medicine composition of the present invention is closely related to the types of herbs in the prescription.

[0079] In summary, the traditional Chinese medicine composition provided by this invention exhibits significant advantages in improving lipid metabolism disorders, reducing cardiac workload, and inhibiting chronic inflammation. It not only improves cardiac function and enhances myocardial contractility but also slows the progression of atherosclerosis, stabilizes plaque structure, and produces a synergistic effect by regulating lipid metabolism and inhibiting inflammatory responses. However, removing the key ingredients Centella asiatica, Abrus precatorius, and Salvia miltiorrhiza resulted in varying degrees of decrease in the aforementioned efficacy, indicating that the traditional Chinese medicine composition of this invention exerts its therapeutic effect by regulating lipid metabolism and inhibiting inflammatory responses, and its efficacy is closely related to the components of the ingredients.

Claims

1. A traditional Chinese medicine composition for treating coronary heart disease, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: ginseng 3-18 parts, astragalus 6-30 parts, centella asiatica 6-30 parts, chicken bone grass 6-30 parts, salvia miltiorrhiza 6-30 parts, chuanxiong rhizome 5-30 parts, safflower 5-20 parts, anemarrhena rhizome 6-30 parts, salvia miltiorrhiza seed 3-12 parts, prepared licorice root 3-12 parts, and bran-fried yam 5-30 parts; in this traditional Chinese medicine composition, ginseng and astragalus are the principal herbs, centella asiatica, chicken bone grass, salvia miltiorrhiza, and chuanxiong rhizome are the assistant herbs, safflower, anemarrhena rhizome, and salvia miltiorrhiza seed are the adjuvant herbs, and prepared licorice root and bran-fried yam are the guiding herbs.

2. The traditional Chinese medicine composition for treating coronary heart disease according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9 parts ginseng, 15 parts astragalus, 15 parts centella asiatica, 15 parts chicken bone grass, 15 parts salvia miltiorrhiza, 10 parts chuanxiong rhizome, 10 parts safflower, 12 parts anemarrhena rhizome, 6 parts salvia miltiorrhiza, 6 parts prepared licorice root, and 15 parts stir-fried yam.

3. A method for preparing a traditional Chinese medicine composition for treating coronary heart disease according to claim 1 or 2, characterized in that, Includes the following steps: Step 1: Weigh out each prepared Chinese medicinal herb according to the prescription ratio as raw material; Step 2: Soak the herbs in 10-15 times their volume of water for 30-60 minutes, based on the amount of herbs taken in Step 1. Step 3: Boil the soaked herbs twice, filter the liquids separately, and combine them. Step 4: Concentrate the combined decoction to obtain a medicinal paste; Step 5: Further process the obtained liquid ointment to prepare the desired dosage form.

4. The method for preparing a traditional Chinese medicine composition for treating coronary heart disease according to claim 3, characterized in that, The decoction method in step 3 is to first bring it to a boil over high heat, then simmer it over low heat for 60 minutes, and filter it to obtain the first decoction. After the decoction is completed, the liquid and the dregs are separated. The dregs are then mixed with water that is 5-10 times the weight of the medicinal materials. The mixture is brought to a boil over high heat, then simmered over low heat for 30 minutes, and filtered to obtain the second decoction. The filtered decoctions are then combined.

5. The method for preparing a traditional Chinese medicine composition for treating coronary heart disease according to claim 3, characterized in that, The further processing in step 5 includes: obtaining dry powder or extract powder by vacuum concentration, spray drying or freeze drying.

6. The method for preparing a traditional Chinese medicine composition for treating coronary heart disease according to claim 3, characterized in that, The preparation of the required dosage form includes: adding excipients and mixing, granulating or compressing to make granules or tablets, or filling powder or granules into empty capsules to prepare capsules, or sterilizing and dispensing clarified drug liquid to prepare oral liquid, or adding suitable binders to make water pills, honey pills or ointments.

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