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

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating coronary heart disease and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from raw medicinal materials of Gualou, Baijiangxi, Banxia, Zhishi, Danshen, Fuling, Renshen, Shuiji, Hongjingtian, Zhimu and Jineijin. The traditional Chinese medicine composition is mainly used for treating coronary heart disease, especially phlegm and blood stasis type of coronary heart disease. The traditional Chinese medicine composition is closely related to the compound pathogenesis of 'qi deficiency as the root, phlegm and blood stasis as the branch, and combined with heat and stagnation', establishes the treatment principle of 'tonifying qi to support the root, resolving phlegm and blood stasis to dredge the branch, and combined with clearing heat and eliminating stagnation to protect the middle energizer', realizes supplementing without stagnation and dredging without damage, and covers the core main symptoms and common symptoms in the course of disease, and meets the long-term clinical use requirements of coronary heart disease in stable stage and recovery stage after stent operation. Therefore, the traditional Chinese medicine composition has important clinical significance and broad market application prospect.

Description

Technical Field

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

[0002] Coronary artery disease (CAD) is one of the leading causes of cardiovascular disease mortality worldwide, and with the accelerating aging of the population, the clinical pressure of its prevention and control is increasing year by year. Modern clinical treatments mainly focus on antiplatelet aggregation, lipid-lowering statins, and interventional vascular surgery. However, the long-term use of these approaches still has many limitations: long-term use of anticoagulants can easily lead to bleeding risks; some patients still have a probability of in-stent restenosis after surgery; and a significant proportion of patients experience persistent and recurring chest pain, chest tightness, shortness of breath, and decreased exercise tolerance. These symptoms are difficult to completely improve with single-drug treatment, and there is an urgent clinical need for more targeted and personalized treatment plans to supplement the existing treatment system.

[0003] In the field of traditional Chinese medicine, coronary heart disease is classified under the traditional disease category of "chest pain" and "heart pain". Through long-term clinical practice, it has been confirmed that the mutual binding of phlegm and blood stasis, and the deficiency of qi and blood stasis are the common core pathogenesis in the current progressive and stable stages of coronary heart disease. When the heart qi is deficient, the blood circulation is weak, and the blood circulation is sluggish, resulting in blood stasis. The body fluids are not transported properly and accumulate into phlegm. Phlegm and blood stasis bind together and block the heart vessels, which can eventually induce typical symptoms such as chest tightness and chest pain, palpitations, dark purple tongue with thick and greasy coating, and wiry and hesitant pulse. Currently, most clinically used treatment formulas are based on the classic Trichosanthes and Allium macrostemon formula with modifications. Although they can achieve the effect of resolving phlegm and promoting yang to a certain extent, most of the existing well-known formulas only focus on the single effects of resolving phlegm or promoting blood circulation and removing blood stasis. They have failed to fully adapt to the complex pathogenesis of phlegm and blood stasis originating from the same source and qi deficiency as the root cause. They generally have the defects of insufficient compatibility and weak synergistic effect: many traditional ancient formulas only cover a few herbs such as Trichosanthes and Allium macrostemon. They lack targeted tonifying components for the root cause of qi deficiency and cannot achieve the balanced effect of promoting blood circulation without harming the body's vital energy and resolving phlegm without depleting qi through gentle compatibility.

[0004] Among the currently available traditional Chinese medicine compound prescriptions for the treatment of coronary heart disease, many fixed combination schemes still have obvious blind spots in clinical compatibility: some compound prescriptions use large amounts of strong and aggressive blood-activating and stasis-removing herbs, which can easily damage the already depleted vital energy of patients with long-term use, and elderly patients with weak constitutions have extremely poor tolerance; some prescriptions that only focus on replenishing qi cannot effectively break down the already congealed phlegm and blood stasis pathological products, and have limited effect on improving the already formed coronary artery stasis plaques; moreover, many existing prescriptions completely ignore the concurrent problems of internal heat and food stagnation in the middle jiao that often accompany the course of coronary heart disease patients - long-term phlegm and blood stasis can easily generate heat and consume body fluids, causing concurrent symptoms such as dry mouth, irritability, and constipation. The dysfunction of spleen and stomach further leads to a decrease in the absorption efficiency of the effective components of the herbs. These kinds of minor defects directly reduce the overall clinical benefit rate of existing compound prescriptions.

[0005] Meanwhile, most of the existing publicly available traditional Chinese medicine (TCM) prescriptions for coronary heart disease with phlegm and blood stasis syndrome have not achieved precise optimization of the formulas targeting this specific core pathogenesis. The selection of herbs is mostly a simple superposition of conventional experience, and they have not formed a complete and synergistic treatment chain of "tonifying qi deficiency, resolving phlegm and turbidity, clearing blood stasis, clearing stagnant heat, and assisting digestion." It is difficult to achieve both immediate relief of patients' chest pain and tightness symptoms while addressing both the root cause and the symptoms, and to regulate the body's constitution and block the progression of the disease due to phlegm and blood stasis in the long term. Developing a dedicated TCM compound that fully matches the core pathogenesis of "phlegm and blood stasis syndrome with qi deficiency and blood stasis" to fill this quality control gap in current clinical practice has become an important research and development direction that urgently needs to be addressed in the field of TCM treatment of coronary heart disease. Summary of the Invention

[0006] The present invention aims to overcome the shortcomings of the prior art and solve the following core technical problems: how to provide a traditional Chinese medicine composition for treating coronary heart disease (especially coronary heart disease of the phlegm-blood stasis type and qi deficiency and blood stasis type), its preparation method and uses.

[0007] Specifically, the present invention is achieved through the following technical solutions: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating coronary heart disease, the composition being made from the following raw materials in parts by weight: Trichosanthes kirilowii 15-30 parts, Allium macrostemon 9-15 parts, Pinellia ternata 6-12 parts, Citrus aurantium 6-12 parts, Salvia miltiorrhiza 15-30 parts, Poria cocos 12-20 parts, Panax ginseng 6-15 parts, Hirudo medicinalis 3-6 parts, Rhodiola rosea 10-20 parts, Anemarrhena asphodeloides 6-12 parts, and Gallus gallus domesticus gizzard lining 15-30 parts.

[0008] Alternatively, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Trichosanthes kirilowii 20-25 parts, Allium macrostemon 10-14 parts, Pinellia ternata 7-11 parts, Citrus aurantium 7-11 parts, Salvia miltiorrhiza 20-25 parts, Poria cocos 14-18 parts, Panax ginseng 8-12 parts, Hirudo medicinalis 3-5 parts, Rhodiola rosea 12-18 parts, Anemarrhena asphodeloides 7-11 parts, and Gallus gallus domesticus gizzard lining 21-24 parts.

[0009] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 22 parts of Trichosanthes kirilowii, 12 parts of Allium macrostemon, 9 parts of Pinellia ternata, 9 parts of Citrus aurantium, 22 parts of Salvia miltiorrhiza, 16 parts of Poria cocos, 10 parts of ginseng, 4 parts of Hirudo medicinalis, 14 parts of Rhodiola rosea, 9 parts of Anemarrhena asphodeloides, and 22 parts of chicken gizzard lining.

[0010] Alternatively, in the above-mentioned traditional Chinese medicine composition, the ginseng is sun-dried ginseng or red ginseng, the trichosanthes is whole trichosanthes, the leech is processed leech, and the pinellia is processed pinellia.

[0011] In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect above, the method comprising the following steps: weighing each raw material in the weight proportions described in the first aspect above, pre-treatment, extraction, and concentration.

[0012] Preferably, in the above preparation method, the traditional Chinese medicine composition of the present invention can be prepared using conventional methods known in the art.

[0013] Preferably, the extraction methods used in this invention include, but are not limited to, decoction extraction, reflux extraction, ultrasonic extraction, and supercritical extraction.

[0014] Preferably, water, commonly used organic solvents in the art, or mixtures thereof can be used to extract the treated active pharmaceutical ingredient.

[0015] Preferably, the organic solvent is methanol, ethanol, propanol, butanol, ethyl acetate, petroleum ether, etc.

[0016] Preferably, the process includes weighing each raw material, pulverizing, extracting, and concentrating.

[0017] Preferably, the extraction method is decoction, and / or the extraction solvent is water or ethanol, and / or the number of decoctions is 1-3, and / or the decoction time for each decoction is 1-3 hours.

[0018] Preferably, water extraction is used (e.g., decoction with water).

[0019] Preferably, the preparation method of the traditional Chinese medicine composition of the present invention includes the following steps: weighing each raw material according to the weight proportions described in the first aspect above, mixing them, soaking them in water for 30-60 minutes, with the amount of water being 8-12 times the total weight of the medicinal materials. First decoction for 1.5-2 hours, filtering to obtain the juice; then adding 6-8 times the amount of water to the dregs, decocting for 1-1.5 hours, and filtering. Combining the two filtrates to prepare a concentrated traditional Chinese medicine paste.

[0020] In a third aspect, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect above, or the traditional Chinese medicine composition prepared by the preparation method described in the second aspect above, in the preparation of a medicament for treating coronary heart disease.

[0021] Alternatively, in the above-mentioned uses, the coronary heart disease is a type of coronary heart disease characterized by phlegm and blood stasis, and qi deficiency and blood stasis.

[0022] Alternatively, in the above-described uses, the drug may be in oral dosage form.

[0023] Alternatively, in the above-described uses, the drug may be a decoction, powder, oral liquid, ointment, granules, tablet, or capsule.

[0024] Compared with the prior art, the present invention has the following beneficial effects: This invention relates to a traditional Chinese medicine composition primarily used to treat coronary heart disease, particularly the type characterized by phlegm-blood stasis and qi deficiency with blood stasis. The composition closely adheres to the complex pathogenesis of "qi deficiency as the root cause, phlegm-blood stasis as the manifestation, accompanied by internal heat and food stagnation," establishing a treatment principle of "tonifying qi and strengthening the body to consolidate the root, resolving phlegm and removing blood stasis to clear the manifestation, and supplementing with heat-clearing and digestion-promoting to protect the middle jiao." This achieves the goal of tonifying without stagnation and clearing without harm, while simultaneously covering the core symptoms and common concurrent symptoms during the course of the disease. It is suitable for long-term clinical use during the stable phase of coronary heart disease and the recovery phase after stent placement. Therefore, this invention's traditional Chinese medicine composition has significant clinical value and broad market application prospects. Attached Figure Description

[0025] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used in conjunction with embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings: Figure 1 Comparison of TNF-α levels among different treatment groups.

[0026] Figure 2 Comparison of IL-1β levels among different treatment groups.

[0027] Figure 3 Comparison of IL-6 levels in different treatment groups.

[0028] Figure 4 HE staining of rat cardiomyocytes.

[0029] Figure 5 Western blot analysis of the effects of Zhuyu Wendan Decoction on the expression of AKT1 and p-AKT1 proteins in rat cardiomyocytes.

[0030] Figure 6 Comparison of AKT1 index among different treatment groups.

[0031] Figure 7 Comparison of p-AKT1 index among different treatment groups.

[0032] Figure 8 Western blot analysis of the effect of Zhuyu Wendan Decoction on TNF-α protein expression in rat cardiomyocytes.

[0033] Figure 9 Comparison of TNF-α levels among different treatment groups.

[0034] Figure 10 Western blot analysis of the effect of Zhuyu Wendan Decoction on IL-1β protein expression in rat cardiomyocytes.

[0035] Figure 11Comparison of IL-1β levels among different treatment groups.

[0036] Figure 12 Western blot analysis of the effects of Zhuyu Wendan Decoction on the expression of NF-κB p65 and p-NF-κB p65 proteins in rat cardiomyocytes.

[0037] Figure 13 Comparison of NF-κB p65 index among different treatment groups.

[0038] Figure 14 Comparison of p-NF-κB p65 index in different treatment groups.

[0039] Figure 15 Comparison of AKT1 index among different treatment groups.

[0040] Figure 16 Comparison of TNF-α levels among different treatment groups.

[0041] Figure 17 Comparison of IL-1β levels among different treatment groups. Detailed Implementation

[0042] The traditional Chinese medicine composition (Zhu Yu Wen Dan Tang) is made from the following raw materials: Trichosanthes kirilowii, Allium macrostemon, Pinellia ternata, Citrus aurantium, Salvia miltiorrhiza, Poria cocos, Panax ginseng, Hirudo medicinalis, Rhodiola rosea, Anemarrhena asphodeloides, and chicken gizzard lining. It is mainly used to treat coronary heart disease, especially coronary heart disease of the phlegm-blood stasis and qi deficiency-blood stasis type.

[0043] The herbal composition of this invention closely follows the complex pathogenesis of "qi deficiency as the root cause, phlegm and blood stasis as the symptoms, accompanied by internal heat and food stagnation". It establishes the principle of treating both the root cause and the symptoms by "tonifying qi and strengthening the body to consolidate the root cause, resolving phlegm and removing blood stasis to clear the symptoms, and supplementing with heat-clearing and digestion-promoting to protect the middle jiao". It achieves the goal of tonifying without stagnation and clearing without harming, while covering the core symptoms and common concurrent symptoms in the course of the disease. It is suitable for long-term clinical use in the stable phase of coronary heart disease and the recovery phase after stent placement.

[0044] The compatibility mechanism and formulation explanation of the traditional Chinese medicine composition of this invention are as follows: The principal ingredient is ginseng. Its core function is to greatly replenish the heart qi and strengthen the body's resistance, directly addressing the root cause of coronary heart disease caused by qi deficiency and blood stasis. When the heart qi is sufficient, the blood circulation is restored, thus blocking the pathological chain of continuous phlegm and blood stasis formation from the root.

[0045] The main ingredients are: Trichosanthes kirilowii, Allium macrostemon, Salvia miltiorrhiza, and Hirudo medicinalis. Trichosanthes kirilowii and Allium macrostemon are a classic herbal pair in the *Synopsis of Prescriptions of the Golden Chamber* for treating chest pain, specifically for resolving phlegm and dispersing nodules, promoting yang and relieving obstruction, directly dissolving the phlegm and turbidity that has accumulated in the heart vessels; Salvia miltiorrhiza and Hirudo medicinalis are the core combination for activating blood and unblocking the meridians. Salvia miltiorrhiza promotes blood circulation without harming the body's vital energy, while Hirudo medicinalis, as an insect-based medicine, penetrates deep into the meridians to break down stubborn stagnation. Together, the two ingredients clear blockages in the heart vessels, quickly improving the core symptoms of chest pain and chest tightness.

[0046] Adjuvant herbs: Pinellia ternata, Citrus aurantium, Poria cocos, Rhodiola rosea, Anemarrhena asphodeloides. Pinellia ternata and Citrus aurantium assist Trichosanthes kirilowii in strengthening the effects of resolving phlegm, eliminating stagnation, regulating qi, and relieving chest tightness, thus improving symptoms of chest tightness and fullness; Poria cocos strengthens the spleen and eliminates dampness, reducing the generation of phlegm and turbidity from the source; Rhodiola rosea assists ginseng in tonifying qi and unblocking the meridians, while also improving the body's ability to tolerate hypoxia and improving the problem of decreased exercise tolerance in patients with coronary heart disease; Anemarrhena asphodeloides clears away the deficiency heat generated by long-term stagnation of phlegm and blood stasis, avoiding the depletion of yin fluid by warm and drying herbs, and relieving the accompanying symptoms of irritability and dry mouth in patients.

[0047] The guiding ingredient is chicken gizzard lining. On the one hand, it strengthens the spleen and promotes digestion, facilitating the absorption of the effective components of all the ingredients in the formula. On the other hand, it eliminates stagnation and avoids the problem of spleen and stomach congestion caused by long-term use of large amounts of qi-tonifying and blood-activating herbs. At the same time, it guides the medicine to the middle jiao and harmonizes the properties of all the ingredients in the formula.

[0048] In the pharmaceutical applications described above, the timing, frequency, and duration of administration of the traditional Chinese medicine composition need to be determined based on the specific diagnostic results of the patient's condition, which is within the technical scope of those skilled in the art. For example, when applying a treatment regimen for mice or rats to humans, the effective dose of all drugs for humans can be converted from the effective dose of the drug for mice or rats, which is easily achievable by those skilled in the art.

[0049] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0050] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0051] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the experimental materials used in the following embodiments are commercially available products.

[0052] Unless otherwise stated, all percentages and parts in this invention refer to weight percentages and weight parts.

[0053] Preparation Example: A traditional Chinese medicine composition for treating coronary heart disease (Zhu Yu Wen Dan Tang), the composition being made from the following raw materials: 22 g of whole Trichosanthes kirilowii, 12 g of Allium macrostemon, 9 g of processed Pinellia ternata, 9 g of Citrus aurantium, 22 g of Salvia miltiorrhiza, 16 g of Poria cocos, 10 g of raw Panax ginseng, 4 g of processed Hirudo medicinalis, 14 g of Rhodiola rosea, 9 g of Anemarrhena asphodeloides, and 22 g of chicken gizzard lining.

[0054] The preparation method of the traditional Chinese medicine composition includes the following steps: Mix the above 11 medicinal materials, soak them in water for 30 minutes (the amount of water is 8 times the total weight of the medicinal materials), decoct for 2 hours initially, filter to obtain the juice; add 6 times the amount of water to the dregs, decoct for about 1 hour, and filter again. Combine the two filtrates to prepare a concentrated traditional Chinese medicine paste with a relative density of 1.2 ± 0.05 (60℃), vacuum seal it, and store it in a refrigerator at 4℃ for later use.

[0055] Example of effect: 1. Laboratory drugs and laboratory animals Experimental drugs: Zhuyu Wendan Decoction (for specific preparation methods, please refer to the preparation examples section), Danshen Dripping Pills, and posterior pituitary injection. The Chinese medicinal materials, prepared Chinese medicines, and injections were all purchased from the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine.

[0056] Experimental animals: 60 male SD rats aged 6-8 weeks (180±20g), all provided by Heilongjiang University of Traditional Chinese Medicine, certificate number: SCXK (Hei) 2023-001, were housed in the animal laboratory of Heilongjiang University of Traditional Chinese Medicine, with free access to water for 24 hours and 12 hours of alternating light and dark lighting. The rats were housed and handled in accordance with the relevant animal ethics regulations of Heilongjiang University of Traditional Chinese Medicine (approval number: 2025122906).

[0057] 2. Animal model establishment, grouping, and drug administration Sixty rats were housed stably for one week, and 10 rats were randomly selected as the normal control group. The remaining 50 rats were used for experimental modeling. A rat model of coronary heart disease was established by feeding a high-fat diet combined with injection of vasopressin. The 50 rats were fed a high-fat diet (15.6% protein + 31.3% fat) for 16 consecutive weeks. 72 hours before the last feeding, vasopressin (30 U / kg) was injected intraperitoneally once a day. -1 The experiment was conducted for 3 consecutive days. After modeling, electrocardiograms were performed on 50 rats using a BL-420F biosignal acquisition system. The successfully modeled rats were randomly divided into a model group, a control group (Danshen Dripping Pills), a low-dose group of Zhuyu Wendan Decoction, a medium-dose group of Zhuyu Wendan Decoction, and a high-dose group of Zhuyu Wendan Decoction. Drug intervention was administered at week 17. The control group received 70 mg / kg of Danshen Dripping Pills suspension by gavage, the low-dose group received 17.1 g / kg of the decoction, the medium-dose group received 34.2 g / kg, and the high-dose group received 68.4 g / kg. The normal group and the model group received an equal volume of pure water by gavage for 4 consecutive weeks. After the experiment, the rats were anesthetized with chloral hydrate, blood was collected from the abdominal aorta, the serum was centrifuged and frozen, and the rat hearts were fixed with 4% paraformaldehyde solution. The remaining portion was frozen at -80℃.

[0058] 3. Indicator Detection and Methods (1) ELISA detection of TNF-α, IL-1β, IL-6 Rat blood samples were centrifuged and the supernatant was collected. The serum levels of TNF-α, IL-1β, and IL-6 in each group of rats were measured according to the instructions of the ELISA kit.

[0059] (2) HE staining to observe the inflammatory cell infiltration of cardiomyocytes Cardiac tissue samples were fixed with 4% paraformaldehyde solution and then dehydrated using a gradient ethanol treatment (75%→80%→95%→100%). Xylene clearing was used to enhance tissue permeability, followed by embedding in molten paraffin. Continuous sections with a thickness of 7 μm were prepared using a precision microtome. After dewaxing and rehydration using a xylene-ethanol gradient, the tissues were stained with hematoxylin and eosin (HE). After mounting with neutral resin, the samples were placed under an optical microscope for microstructural observation and digital image acquisition.

[0060] (3) Western blot analysis of the levels of AKT1, p-AKT1, TNF-α, IL-1β, NF-κB p65, and p-NF-κB p65 in cardiomyocytes. Rat myocardial tissue was thoroughly ground and lysed to extract proteins. BCA was used to quantify the proteins, followed by electrophoresis separation and membrane transfer. The membrane was blocked with 5% skim milk powder for 1 hour, and then incubated overnight at 4°C with primary antibodies against AKT1 (1:500 dilution), IL-1β (1:1000 dilution), TNF-α (1:1000 dilution), NF-κB p65 (1:1000 dilution), IκBα (1:500 dilution), and β-actin (1:1000 dilution). After washing the membrane, secondary antibodies were added for incubation and color development. Gel imaging was performed, and ImageJ software was used for semi-quantitative analysis of the optical density values ​​of the bands. β-actin was used as an internal control to calculate the relative expression levels of each protein.

[0061] (4) RT-PCR detection of the levels of AKT1, TNF-α, and IL-1β in rat cardiomyocytes Total RNA was extracted from the thoracic aortic tissue of each group using an RNA extraction kit, and cDNA was synthesized. After qRT-PCR analysis, β-actin was used as an internal reference gene for standardization, and the mRNA expression of AKT1, TNF-α, IL-1β, and NF-κB p65 was calculated using the 2-ΔΔCt method. Primer sequences are shown in Table 1 below.

[0062] Table 1 4. Statistical Analysis Data statistical analysis was performed using GraphPad Prism 8.0.2 software. Quantitative data were expressed as mean ± standard deviation (x ± s). One-way ANOVA was used for multiple group comparisons, and P < 0.05 was considered statistically significant.

[0063] 5. Results 5.1 Effects of Zhuyu Wendan Decoction on Serum TNF-α, IL-1β, and IL-6 Levels in Rats Figure 1 The comparison of TNF-α levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=307.3, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05). The results indicate that Zhuyu Wendan Decoction can reduce serum TNF-α levels in rats.

[0064] Figure 2 The comparison of IL-1β levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=1043, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05). The results indicate that Zhuyu Wendan Decoction can reduce serum IL-1β levels in rats.

[0065] Figure 3 The comparison of IL-6 levels among different treatment groups is shown. Data are expressed as mean ± standard deviation (x±s), n=6. One-way ANOVA showed significant differences among groups (F(5,12)=1145, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05), with no statistically significant difference between groups C and F (P=0.1845). The results indicate that Zhuyu Wendan Decoction can reduce serum IL-6 levels in rats.

[0066] right Figures 1 to 3 The experimental results are summarized in Table 2.

[0067] 5.2 HE staining to observe inflammatory cell infiltration in rat myocardial tissue like Figure 4 As shown, compared with the normal group (i.e. Figure 4Compared to the control group, the model group showed disordered myocardial tissue structure, irregular arrangement of myocardial fibers, widened interstitium, mild inflammatory cell infiltration, and some degree of perivascular stenosis. In contrast, the high-dose group showed more regular arrangement of myocardial fibers, improved tissue integrity, reduced inflammatory cell infiltration, and a lessened tendency for perivascular stenosis, suggesting that high-dose treatment has a significant ameliorative effect on myocardial tissue damage induced by the model.

[0068] 5.3 Effects of Zhuyu Wendan Decoction on the expression of AKT1, p-AKT1, TNF-α, IL-1β, NF-κB p65, and p-NF-κB p65 proteins in rat myocardial tissue Figure 5 The effects of Zhuyu Wendan Decoction on the expression of AKT1 and p-AKT1 proteins in rat cardiomyocytes were shown by Western blot analysis. Figure 6 The comparison of AKT1 levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=9414, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05). The results indicate that Zhuyu Wendan Decoction can inhibit AKT1 protein expression in rat cardiomyocytes. Figure 7 The comparison of p-AKT1 levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=43506, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05). The results indicate that Zhuyu Wendan Decoction can inhibit p-AKT1 protein expression in rat cardiomyocytes.

[0069] Figure 8 The effect of Zhuyu Wendan Decoction on TNF-α protein expression in rat cardiomyocytes was shown by Western blot analysis. Figure 9 The comparison of TNF-α levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=42847, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05). The results indicate that Zhuyu Wendan Decoction can inhibit TNF-α protein expression in rat cardiomyocytes.

[0070] Figure 10 The effect of Zhuyu Wendan Decoction on IL-1β protein expression in rat cardiomyocytes was shown by Western blot analysis. Figure 11The comparison of IL-1β levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=35239, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05). The results indicate that Zhuyu Wendan Decoction can inhibit IL-1β protein expression in rat cardiomyocytes.

[0071] Figure 12 The effects of Zhuyu Wendan Decoction on the expression of NF-κB p65 and p-NF-κBp65 proteins in rat cardiomyocytes were shown by Western blot analysis. Figure 13 This study compares the NF-κB p65 index across different treatment groups. Data are expressed as mean ± standard deviation (x±s), n=6. One-way ANOVA showed significant differences between groups (F(5,12)=135.3, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05), with no statistically significant differences between groups B and C, and between groups E and F (P=0.9994 and 0.9819, respectively). Figure 14 This study compares the p-NF-κB p65 levels across different treatment groups. Data are expressed as mean ± standard deviation (x±s), n=6. One-way ANOVA showed significant differences among groups (F(5,12)=44013, P<0.0001); Tukey's post-hoc multiple comparison test confirmed that different lowercase letters indicated statistically significant differences between groups (P<0.05). The results indicate that Zhuyu Wendan Decoction can inhibit p-NF-κB p65 protein expression in rat cardiomyocytes.

[0072] 5.4 Effects of Zhuyu Wendan Decoction on the expression of AKT1, TNF-α, and IL-1β mRNA in rat myocardial tissue Figure 15 The comparison of AKT1 levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=318.3, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05). The results indicate that Zhuyu Wendan Decoction can inhibit AKT1 mRNA expression in rat cardiomyocytes.

[0073] Figure 16The comparison of TNF-α levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=187.6, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences between groups (P<0.05), with no statistically significant difference between group C and group F (P=0.6819). The results indicate that Zhuyu Wendan Decoction can inhibit TNF-α mRNA expression in rat cardiomyocytes.

[0074] Figure 17 The comparison of IL-1β levels among different treatment groups is shown. Data are expressed as x±s, n=6. One-way ANOVA showed significant differences among groups (F(5,12)=125.0, P<0.0001); Tukey's post-hoc multiple comparison test showed that different lowercase letters indicated statistically significant differences among groups (P<0.05), with no statistically significant differences between groups A and C, A and F, C and F, and E and F (P=0.9432, 0.1624, 0.5294, and 0.0862, respectively). The results indicate that Zhuyu Wendan Decoction can inhibit IL-1β mRNA expression in rat cardiomyocytes.

[0075] right Figures 15 to 17 The experimental results are summarized in Table 3.

[0076] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

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: Trichosanthes kirilowii 15-30 parts, Allium macrostemon 9-15 parts, Pinellia ternata 6-12 parts, Citrus aurantium 6-12 parts, Salvia miltiorrhiza 15-30 parts, Poria cocos 12-20 parts, Panax ginseng 6-15 parts, Hirudo medicinalis 3-6 parts, Rhodiola rosea 10-20 parts, Anemarrhena asphodeloides 6-12 parts, and Gallus gallus domesticus gizzard lining 15-30 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: Trichosanthes kirilowii 20-25 parts, Allium macrostemon 10-14 parts, Pinellia ternata 7-11 parts, Citrus aurantium 7-11 parts, Salvia miltiorrhiza 20-25 parts, Poria cocos 14-18 parts, Panax ginseng 8-12 parts, Hirudo medicinalis 3-5 parts, Rhodiola rosea 12-18 parts, Anemarrhena asphodeloides 7-11 parts, and Gallus gallus domesticus gizzard lining 21-24 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 22 parts of Trichosanthes kirilowii, 12 parts of Allium macrostemon, 9 parts of Pinellia ternata, 9 parts of Citrus aurantium, 22 parts of Salvia miltiorrhiza, 16 parts of Poria cocos, 10 parts of ginseng, 4 parts of Hirudo medicinalis, 14 parts of Rhodiola rosea, 9 parts of Anemarrhena asphodeloides, and 22 parts of chicken gizzard lining.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The ginseng is either sun-dried ginseng or red ginseng, the trichosanthes is whole trichosanthes, the leech is processed leech, and the pinellia is processed pinellia.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method includes the following steps: weighing each raw material according to the weight proportions of any one of claims 1 to 4, pre-treating, extracting, and concentrating.

6. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4, or the traditional Chinese medicine composition prepared by the preparation method according to claim 5, in the preparation of a medicament for treating coronary heart disease.

7. The use according to claim 6, characterized in that: The coronary heart disease mentioned is a type of coronary heart disease characterized by phlegm and blood stasis, and qi deficiency and blood stasis.

8. The use according to claim 6, characterized in that: The drug is an oral dosage form.

9. The use according to claim 8, characterized in that: The medicine is in the form of decoction, powder, oral liquid, ointment, granules, tablets or capsules.

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