Traditional Chinese medicine composition for treating chronic heart failure, preparation, preparation method and application

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for treating chronic heart failure, a preparation, a preparation method and application. The composition is prepared from the following medicinal materials in parts by weight: 6 to 12 parts of radix aconiti lateralis preparata, 6 to 12 parts of cassia twig, 6 to 10 parts of fructus aurantii immaturus, 6 to 10 parts of cortex magnoliae officinalis, 6 to 10 parts of zanthoxylum bungeanum maxim, 10 to 15 parts of semen lepidii, 15 to 20 parts of poria cocos, 4 to 8 parts of caulis clematidis armandii, 15 to 20 parts of radix pseudostellariae, 10 to 15 parts of lily, 10 to 15 parts of fried semen boitae, 10 to 15 parts of fresh ginger, 15 to 20 parts of radix paeoniae alba and 10 to 15 parts of radix achyranthis bidentatae. The invention provides the self-prepared traditional Chinese medicine composition for treating the chronic heart failure, all the medicine pairs in the traditional Chinese medicine composition finally exert a powerful treatment effect on the CHF through a synergistic effect, effect enhancement, toxicity reduction and multi-target regulation, and animal experiments verify that the self-prepared traditional Chinese medicine composition has a remarkable curative effect on the CHF and is free of toxic and side effects. A novel traditional Chinese medicine treatment thought is provided for clinical treatment of the CHF disease.

Description

Technical fields:

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition, preparation, preparation method and application for treating chronic heart failure. Background technology:

[0002] Chronic heart failure (CHF) is a syndrome caused by structural or functional abnormalities of the heart, primarily characterized by decreased cardiac output and / or increased intracardiac pressure, leading to congestion in the systemic and pulmonary circulations and insufficient tissue perfusion. Typical clinical symptoms include dyspnea, fatigue, and edema. CHF is the end-stage of various cardiovascular diseases, with high morbidity and mortality. Common Western medicine treatments for CHF include ACE inhibitors, renin-angiotensin-aldosterone system inhibitors, β2 receptor blockers, and angiotensin receptor blockers. However, some of these drugs, if used improperly over a long period, can lead to drug resistance and side effects, and may even increase the risk of CHF mortality. Traditional Chinese medicine plays an irreplaceable role in alleviating symptoms, improving quality of life, and enhancing prognosis in patients with chronic heart failure.

[0003] Traditional Chinese medicine (TCM) herbal pairs are widely used in the treatment of chronic hepatitis folliculitis (CHF). For example, ginseng and aconite (Renzi) in the Shenfu Decoction are a classic combination for restoring yang and rescuing from collapse, suitable for cases of heart and kidney yang deficiency. Another example is the Danshen Decoction, which combines danshen with sandalwood; danshen invigorates blood and removes blood stasis, while sandalwood promotes qi circulation and relieves pain, improving chest pain. Furthermore, the Linggui Zhugan Decoction, which combines poria with cinnamon twig, warms yang, promotes qi circulation, and eliminates dampness, treating the upward flow of phlegm. Based on these, TCM compound formulas can leverage their multi-component, multi-target, and multi-pathway characteristics in CHF treatment, regulating inflammatory responses, improving myocardial remodeling, and regulating energy metabolism. However, the number of TCM compound formulas actually used in the clinical treatment of CHF is still relatively limited, and their efficacy has certain limitations. Therefore, there is an urgent need to develop new TCM compound formulas that can provide a reference for the clinical treatment of CHF. Summary of the Invention:

[0004] To address the shortcomings of existing technologies, this invention provides a self-formulated traditional Chinese medicine (TCM) composition for treating chronic heart failure (CHF). The various drug pairs in this TCM compound exert a powerful therapeutic effect on CHF through synergistic effects, enhanced efficacy, reduced toxicity, and regulation of multiple targets. Furthermore, animal experiments have verified the significant efficacy of this self-formulated TCM compound against CHF, providing a new TCM treatment approach for the clinical treatment of this disease. In researching this self-formulated TCM compound, the pathogenesis of CHF was analyzed in depth. Based on classic TCM treatment formulas, drug pairs were added or subtracted, ultimately forming the unique TCM composition of this invention. Each drug in the formula plays a specific role, works synergistically, and is indispensable.

[0005] In traditional Chinese medicine, CHF falls under the categories of "palpitation," "asthma," and "edema," with its core pathogenesis being a deficiency of the root and an excess of the branch. The root deficiency is primarily due to a deficiency of heart qi (yang), gradually affecting the lungs, spleen, and kidneys; the branch excess mainly involves water retention and phlegm. Treatment must address both the root and the branch. The fundamental cause of CHF lies in the weakness of heart qi, which is unable to propel blood circulation, leading to a decline in the function of all the internal organs. Warming and tonifying heart qi and heart yang is the fundamental treatment. Deficiency of heart yang prevents the transformation and warming of fluids, resulting in the retention of water retention. This retention of water retention then condenses into phlegm. Excessive use of warming and drying herbs may lead to deficiency of both qi and yin. Therefore, this invention, while considering the core pathogenesis of CHF, emphasizes the use of diuretic, edema-reducing, phlegm-resolving, and fluid-resolving herbs, supplemented by yin-nourishing and calming herbs to prevent damage to yin from warming and drying. Finally, based on classic compound formulas such as Zhenwu Decoction and Wuling Powder, this invention's self-formulated compound formula is obtained through modifications.

[0006] Specifically, the first aspect of this invention provides a traditional Chinese medicine composition for treating chronic heart failure, comprising the following medicinal materials: prepared aconite root, cinnamon twig, immature bitter orange, magnolia bark, pepper seeds, lepidium seed, poria cocos, akebia stem, codonopsis root, lily bulb, stir-fried arborvitae seed, fresh ginger, white peony root, and achyranthes root. In this formula, prepared aconite root and cinnamon twig are the principal herbs. Prepared aconite root warms the kidneys and assists yang, transforming qi and promoting water metabolism; cinnamon twig warms and invigorates heart yang, transforming qi and promoting water metabolism. Together, they warm the kidney yang to transform water metabolism. The formula consists of the following herbs: Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis, Fructus Zanthoxyli, Fructus Lepidium, Poria, and Rhizoma Akebiae. Fructus Aurantii Immaturus and Cortex Magnoliae Officinalis work together to regulate qi, resolve phlegm, eliminate stagnation, and relieve fullness, thus enhancing the formula's qi-regulating and diuretic effects. Fructus Zanthoxyli and Fructus Lepidium are combined for their potent effects in purging the lungs, relieving asthma, and promoting diuresis and reducing swelling. Poria assists Fructus Zanthoxyli in promoting diuresis and also protects the middle jiao (middle burner). Rhizoma Akebiae promotes urination and enhances its diuretic and swelling-reducing effects. The formula also includes the following herbs: Radix Codonopsis, Radix Lilium Bulbati, Semen Platycladi (fried), Semen Zingiberis (fresh), and Radix Paeoniae Alba (white peony root). Radix Codonopsis pilosula tonifies qi, Radix Lilium Bulbati nourishes yin, and Semen Platycladi (fried) calms the mind. Together, they nourish yin and calm the mind. Radix Codonopsis pilosula also supports the body's resistance and moderates the potent effects of Fructus Lepidium. Ginger assists Rhizoma Aconitum (processed) in warming yang, while Radix Paeoniae Alba moderates the warming and drying properties of Rhizoma Aconitum and Cinnamomi Ramulus to prevent yin damage. Radix Achyranthis Bidentatae (beneficial herb) is the guiding herb, promoting urination, relieving strangury, and guiding the medicine downwards. Specifically: Prepared aconite root is a processed product of the rootlets of *Aconitum carmichaelii* Debx., a plant in the Ranunculaceae family, processed through steaming and other methods. It is pungent, sweet, and very hot in nature; it is toxic. It enters the heart, kidney, and spleen meridians. It can restore yang and rescue from collapse, tonify fire and assist yang, dispel cold and relieve pain.

[0007] Cinnamon twigs are the dried young branches of *Cinnamomum cassia* Presl, a plant in the Lauraceae family. They are pungent, sweet, and warm in nature. They enter the heart, lung, and bladder meridians. They can induce sweating to relieve muscle tension, warm and unblock the meridians, and assist yang qi circulation.

[0008] Citrus aurantium L. (sour orange) or Citrus sinensis Osbeck (sweet orange) are dried young fruits belonging to the Rutaceae family. They are bitter, pungent, and sour in taste, and slightly cold in nature. They enter the spleen and stomach meridians. They can break up qi stagnation, eliminate stagnation, resolve phlegm, and disperse masses.

[0009] Magnolia officinalis (Houpu) is the dried bark, root bark, or branch bark of Magnolia officinalis Rehd. et Wils. or Magnolia officinalis var. biloba Rehd. et Wils., belonging to the Magnoliaceae family. It is bitter, pungent, and warm in nature. It enters the spleen, stomach, lung, and large intestine meridians. It can dry dampness, resolve phlegm, and relieve abdominal distension.

[0010] Zanthoxylum bungeanum Maxim. or Zanthoxylum schinifolium Sieb. et Zucc., belonging to the Rutaceae family, are dried, mature seeds. They are bitter, pungent, and cold in nature. They enter the spleen, lung, and kidney meridians. They can promote diuresis, reduce swelling, and relieve asthma.

[0011] Lepidium apetalum Willd. or Descurainia sophia (L.) Webb ex Prantl are the dried, mature seeds of plants in the Brassicaceae family. They are pungent, bitter, and very cold in nature. They enter the Lung and Bladder meridians. They can clear lung heat, relieve asthma, promote urination, and reduce swelling.

[0012] Poria cocos is the dried sclerotium of the fungus *Poria cocos* (Schw.) Wolf, belonging to the Polyporaceae family. It is sweet, bland, and neutral in nature. It enters the heart, lung, spleen, and kidney meridians. It can promote diuresis and eliminate dampness, strengthen the spleen, and calm the mind.

[0013] *Clematis armandii* Franch. or *Clematis montana* Buch.-Ham. ex DC., belonging to the Ranunculaceae family, are dried vines. They are bitter and cold in nature. They enter the heart, small intestine, and bladder meridians. They can clear heat, promote diuresis, regulate menstruation, and promote lactation.

[0014] Prince ginseng is the dried tuberous root of *Pseudostellaria heterophylla* (Miq.) Pax exPax et Hoffm., a plant in the Caryophyllaceae family. It is sweet and slightly bitter in taste, and neutral in nature. It enters the spleen and lung meridians. It can invigorate qi and strengthen the spleen, promote the production of body fluids and moisten the lungs.

[0015] Lily refers to the dried, fleshy scales of the lily plants *Lilium lancifolium* Thunb., *Lilium brownii* F.E. Brown var. *viridulum* Baker, or *Lilium pumilum* DC. It is sweet and cold in nature, and enters the heart and lung meridians. It nourishes yin and moistens the lungs, clears the heart and calms the mind.

[0016] Fried arborvitae seed kernels are the dried, mature seeds of the arborvitae plant (Platycladus orientalis) (L.) Franco, processed through roasting. They are sweet and neutral in nature, and enter the heart, kidney, and large intestine meridians. They nourish the heart and calm the mind, and moisten the intestines to relieve constipation.

[0017] Ginger is the fresh rhizome of *Zingiber officinale* Rosc., a plant in the ginger family (Zingiberaceae). It is pungent and warm in nature, and enters the lung, spleen, and stomach meridians. It can relieve exterior syndromes and dispel cold, warm the middle jiao and stop vomiting, and resolve phlegm and stop coughing.

[0018] White peony root is the dried root of Paeonia lactiflora Pall., a plant in the Ranunculaceae family. It is bitter and sour in taste, and slightly cold in nature. It enters the liver and spleen meridians. It nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang.

[0019] Achyranthes bidentata Bl., a plant in the Amaranthaceae family, is the dried root of the plant. It is bitter, sweet, and sour in taste, and neutral in nature. It enters the liver and kidney meridians. It can dispel blood stasis and promote menstruation, tonify the liver and kidneys, strengthen tendons and bones, promote urination and relieve strangury, and guide blood downwards.

[0020] As a further explanation of the present invention, the composition comprises the following medicinal materials in parts by weight: 6-12 parts of processed aconite root, 6-12 parts of cinnamon twig, 6-10 parts of immature bitter orange, 6-10 parts of magnolia bark, 6-10 parts of pepper seeds, 10-15 parts of lepidium seed, 15-20 parts of poria cocos, 4-8 parts of akebia stem, 15-20 parts of codonopsis root, 10-15 parts of lily bulb, 10-15 parts of stir-fried arborvitae seed, 10-15 parts of fresh ginger, 15-20 parts of white peony root, and 10-15 parts of achyranthes root.

[0021] As a further explanation of the present invention, the composition consists of the following medicinal materials in parts by weight: 9 parts prepared aconite root, 9 parts cinnamon twig, 8 parts immature bitter orange, 8 parts magnolia bark, 8 parts pepper seeds, 12 parts lepidium seed, 18 parts poria cocos, 5 parts akebia stem, 18 parts codonopsis root, 12 parts lily bulb, 12 parts stir-fried arborvitae seed, 12 parts fresh ginger, 18 parts white peony root, and 12 parts achyranthes root.

[0022] A second aspect of the present invention provides a method for preparing a traditional Chinese medicine composition for treating chronic heart failure, comprising the following steps: S1: Prepare a traditional Chinese medicine fluid extract from the traditional Chinese medicine composition described in any one of the above-mentioned methods for later use; S2: Add clinically acceptable excipients to the fluid extract of traditional Chinese medicine obtained in step S1, and prepare it using conventional formulation methods to produce a clinically acceptable oral traditional Chinese medicine preparation.

[0023] As a further explanation of the present invention, the traditional Chinese medicine preparation is any one of decoction, powder, pill, granule, capsule, tablet, drop pill, syrup, or oral liquid.

[0024] As a further explanation of the present invention, in S1, the traditional Chinese medicine fluid extract is prepared by any one of the following methods: decoction concentration method, percolation method, maceration concentration method, and reflux extraction concentration method.

[0025] As a further explanation of the present invention, in S1, when using the decoction and concentration method, the prepared aconite is decocted separately for 1-1.5 hours before the other medicinal materials are added, and the lepidium seed is decocted by wrapping it in a decoction.

[0026] A third aspect of the present invention provides a traditional Chinese medicine preparation for treating chronic heart failure, wherein the traditional Chinese medicine preparation is made by conventional formulation methods using the traditional Chinese medicine composition described in any one of the above-mentioned methods and clinically acceptable excipients.

[0027] The fourth aspect of the present invention provides the use of the traditional Chinese medicine composition described in any one of the above-mentioned methods, or the traditional Chinese medicine preparation made by any one of the above-mentioned methods, or the traditional Chinese medicine preparation described in any one of the above-mentioned methods, in the preparation of a medicament for treating chronic heart failure.

[0028] Compared with the prior art, the present invention has the following beneficial technical effects: This invention provides a self-formulated traditional Chinese medicine composition for treating chronic heart failure. The drug pairs in this composition exert a strong therapeutic effect on CHF through synergistic effects, enhanced efficacy and reduced toxicity, and regulation of multiple targets. Furthermore, animal experiments have verified that the self-formulated traditional Chinese medicine compound provided by this invention has a significant therapeutic effect on CHF, providing a new TCM treatment approach for the clinical treatment of CHF. Attached image description: Figure 1 HE staining results of heart tissue from each group of rats, among which Figure 1 (a)- Figure 1 (d) The staining results of rats in the blank group, model group, positive control group and Example 1 group, respectively. Detailed implementation method:

[0029] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] Example 1 This embodiment provides a traditional Chinese medicine composition for treating chronic heart failure, which consists of the following medicinal materials in parts by weight: 9 parts prepared aconite root, 9 parts cinnamon twig, 8 parts immature bitter orange, 8 parts magnolia bark, 8 parts pepper seeds, 12 parts lepidium seed, 18 parts poria cocos, 5 parts akebia stem, 18 parts codonopsis root, 12 parts lily bulb, 12 parts stir-fried arborvitae seed, 12 parts fresh ginger, 18 parts white peony root, and 12 parts achyranthes root.

[0031] Example 2 This embodiment provides a traditional Chinese medicine composition for treating chronic heart failure, which consists of the following medicinal materials in parts by weight: 6 parts prepared aconite root, 6 parts cinnamon twig, 6 parts immature bitter orange, 6 parts magnolia bark, 6 parts pepper seeds, 10 parts lepidium seed, 15 parts poria cocos, 4 parts akebia stem, 15 parts codonopsis root, 10 parts lily bulb, 10 parts stir-fried arborvitae seed, 10 parts fresh ginger, 15 parts white peony root, and 10 parts achyranthes root.

[0032] Example 3 This embodiment provides a traditional Chinese medicine composition for treating chronic heart failure, which consists of the following medicinal materials in parts by weight: 12 parts prepared aconite root, 12 parts cinnamon twig, 10 parts immature bitter orange, 10 parts magnolia bark, 10 parts pepper seeds, 15 parts lepidium seed, 20 parts poria cocos, 8 parts akebia stem, 20 parts codonopsis root, 15 parts lily bulb, 15 parts stir-fried arborvitae seed, 15 parts fresh ginger, 20 parts white peony root, and 15 parts achyranthes root.

[0033] Comparative Example 1: This comparative example provides a traditional Chinese medicine composition for treating chronic heart failure. The difference between this composition and Example 1 is that Fructus Aurantii Immaturus and Cortex Magnoliae Officinalis are removed from the composition.

[0034] Comparative Example 2: This comparative example provides a traditional Chinese medicine composition for treating chronic heart failure. The difference between this composition and Example 1 is that the pepper seeds and lepidium seeds are removed from the composition.

[0035] Comparative Example 3: This comparative example provides a traditional Chinese medicine composition for treating chronic heart failure. The difference between this composition and Example 1 is that Poria cocos and Akebia trifoliata are removed from the composition.

[0036] Comparative Example 4: This comparative example provides a traditional Chinese medicine composition for treating chronic heart failure. The difference between this composition and Example 1 is that the ingredients of Codonopsis pilosula, lily bulb, and stir-fried Platycladus orientalis seeds are removed.

[0037] Comparative Example 5: This comparative example provides a traditional Chinese medicine composition for treating chronic heart failure. The difference between this composition and Example 1 is that ginger and white peony root are removed from the formula.

[0038] The traditional Chinese medicine compositions provided in the above examples and comparative examples are prepared into traditional Chinese medicine fluid extracts using concentration methods such as decoction concentration, percolation, maceration concentration, and reflux extraction concentration. Then, clinically acceptable excipients are added, and conventional formulation methods are used to prepare them into clinically acceptable oral traditional Chinese medicine preparations, such as decoctions, powders, pills, granules, capsules, tablets, drop pills, syrups, and oral liquids.

[0039] The Chinese herbal extract powder used in the following animal experiments is the Chinese herbal fluid extract obtained by decocting and concentrating the Chinese herbal composition provided in the above examples and comparative examples, and then dried under vacuum.

[0040] Specifically, weigh each herb in the above-described embodiments and comparative examples according to the prescribed proportions, add cold water (3-5 cm above the herbs) and soak for 60 minutes. Then bring to a boil over high heat, reduce to a simmer and cook for 45 minutes. Filter the liquid. Add water (2 / 3 of the first volume) to the remaining dregs, bring to a boil over high heat, then reduce to a simmer and cook for 30 minutes. Combine the two liquids, filter out impurities, and concentrate to a viscous paste (relative density 1.10-1.30). Vacuum dry the concentrated paste and grind it into a fine powder to obtain the dry herbal extract powder. Note that the prepared aconite root needs to be decocted separately for about 1 hour beforehand, tasting until there is no numbing sensation on the tongue to remove its toxicity; while the lepidium seed, due to its small size and hairs, must be wrapped in clean gauze and decocted using the wrapped-and-decoction method.

[0041] The following animal experiments were used to verify the efficacy of the traditional Chinese medicine compositions provided in the embodiments and comparative examples of this invention on chronic heart failure.

[0042] 1. Experimental materials: 1.1 Laboratory Animals SPF-grade male SD rats, aged 6-8 weeks and with an average weight of (200g±20g), were purchased from the Animal Experiment Center of Heilongjiang University of Traditional Chinese Medicine. After purchase, they were acclimatized under standard laboratory conditions for one week before subsequent experiments were conducted.

[0043] 1.2 Experimental reagents: The traditional Chinese medicine dry extract powders prepared from the traditional Chinese medicine compositions provided in the above embodiments and comparative examples.

[0044] Doxorubicin Hydrochloride (ADR), specification 25mg (98%), CAS: 25316-40-9, production number: D807083, Shanghai Maclean Biochemical Technology Co., Ltd.

[0045] Captopril tablets, 25mg, National Drug Approval Number H13021309, manufactured by CSPC Ouyi Pharmaceutical Co., Ltd.

[0046] 2. Experimental methods: 2.1 Animal model establishment, grouping, and drug administration A rat model of chronic heart failure (CHF) was artificially induced using doxorubicin (ADR). Except for the control group, all other rats were intraperitoneally injected with ADR (a solution of purchased doxorubicin hydrochloride powder dissolved in physiological saline to a concentration of 2.5 mg / mL) to establish the CHF rat model. The control group received an equal volume of physiological saline. The single dose was 2.5 mg / kg, administered once weekly for 6 weeks. Six weeks after modeling, cardiac function was assessed using small animal ultrasound: successful modeling was defined as a left ventricular ejection fraction (LVEF) ≤50% and a left ventricular fractional shortening (LVFS) ≤25%.

[0047] Experimental grouping: The successfully modeled rats were randomly divided into 8 groups of 10 each, namely the model group, positive control group, Example 1 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group, and comparative example 5 group. Ten healthy rats that did not undergo modeling were also selected as the blank group.

[0048] Administration: 24 hours after successful model establishment, rats in Example 1 group were administered the herbal extract powder prepared from the herbal composition provided in Example 1, and rats in Comparative Examples 1-5 were administered the same herbal extract powder. The herbal extract powder for each group was administered by gavage at a dose of 5 g / kg once daily. Rats in the positive control group were administered captopril by gavage at a dose of 5 mg / kg once daily. The model group and blank group were administered an equal volume of physiological saline by gavage at corresponding time points. All rats in each group underwent continuous administration for four weeks before their indicators were measured.

[0049] 2.2 Detection Indicators and Methods 2.2.1 Detection of serum biochemical markers The concentrations of heart failure-related markers creatine kinase isoenzyme (CK-MB), N-terminal pro-B-type brain natriuretic peptide (NT-proBNP), and cardiac troponin I (cTn-I) in rat serum were detected by ELISA.

[0050] 2.2.1 Cardiac function testing Changes in left ventricular ejection fraction (LVEF) and left ventricular stenosis fraction (LVFS) were detected using small animal ultrasound in rats.

[0051] 2.2.3 Histopathological observation Heart tissue was fixed with 4% paraformaldehyde solution, washed and dehydrated with xylene, then embedded in paraffin and dried. After hematoxylin-eosin (HE) staining, the tissue was dehydrated, cleared, and mounted. The morphology of rat cardiomyocytes was observed under a microscope after staining.

[0052] 3. Statistical Analysis Statistical analysis was performed using SPSS 25.0 software. Normally distributed measurement data were expressed as mean ± standard deviation (x±s); all tests were performed with p<0.05 or p<0.01 considered statistically significant.

[0053] 4. Experimental Results 4.1 Results of detection of biochemical markers in the serum of rats in each group

[0054] Note: ## P<0.01 compared with the blank group; ** P<0.01 compared with the model group; ∆ P<0.05 compared with Example 1 group; ∆∆ P<0.01 compared with Example 1 group; n=10.

[0055] Creatine kinase isoenzyme (CK-MB) is an important biomarker of myocardial injury; N-terminal pro-B-type natriuretic peptide (NT-proBNP) is an important biomarker of ventricular wall stress / tension (pressure and volume overload), which can reflect the severity of heart failure; cardiac troponin I (cTn-I) is a specific biomarker of cardiomyocyte damage / necrosis. This invention reflects the differences in myocardial injury, severity of heart failure, and persistence of heart failure among different groups of rats by measuring the concentrations of these three biomarkers in the serum of different groups of rats. Specifically, as shown in Table 1, the serum levels of CK-MB, NT-proBNP, and cTn-I in the model group rats were significantly higher than those in the control group, and the intergroup comparison P<0.01, which is statistically significant, indicating that the serum levels of CK-MB, NT-proBNP, and cTn-I in rats with chronic heart failure were significantly higher than those in healthy rats. The serum levels of CK-MB, NT-proBNP, and cTn-I in the positive control group and Example 1 group were significantly lower than those in the model group (P<0.01), indicating a statistically significant difference. This demonstrates that the traditional Chinese medicine composition provided by this invention has a significant effect on improving cardiac function in rats with chronic heart failure, and the improvement effect is basically equivalent to that of Western medicine. However, the serum levels of CK-MB, NT-proBNP, and cTn-I in Comparative Examples 1-5 were higher than those in Example 1 group (P<0.05), indicating a statistically significant difference. This shows that the absence of certain traditional Chinese medicine pairs in the composition significantly affects the efficacy of the composition. It also demonstrates that the various drug pairs in the composition provided by this invention exert a powerful therapeutic effect on CHF through synergistic effects, enhanced efficacy, reduced toxicity, and regulation of multiple targets; each drug pair in the formula is indispensable.

[0056] 4.2 Results of cardiac function index detection in each group of rats

[0057] Note: ## P<0.01 compared with the blank group; ** P<0.01 compared with the model group; ∆ P<0.05 compared with Example 1 group; ∆∆ P<0.01 compared with Example 1 group; n=10.

[0058] In animal experiments and clinical studies related to chronic heart failure, LVEF (left ventricular ejection fraction) and LVFS (left ventricular fractional shortening) are two core indicators for assessing left ventricular systolic function via echocardiography. They directly reflect the heart's pumping capacity and are key parameters for determining the success of heart failure models and assessing the severity of heart failure. Therefore, this invention tested the LVEF and LVFS levels in different groups of rats. Specifically, as shown in Table 2, the LVEF and LVFS levels in the model group were significantly lower than those in the control group, and the LVEF and LVFS levels met the requirements of ≤50% and ≤25%, respectively. The LVEF and LVFS levels in the positive control group and the Example 1 group were significantly higher than those in the model group, with a statistically significant difference (P<0.01). This indicates that the traditional Chinese medicine composition provided by this invention has a significant improving effect on cardiac function in rats with chronic heart failure, and the improvement effect is basically equivalent to that of Western medicine. The LVEF and LVFS levels of rats in Comparative Examples 1-5 were lower than those in Example 1, with P<0.05 between groups, indicating a statistically significant difference. This demonstrates that the absence of certain herbal pairs in the herbal composition of this invention significantly affects the efficacy of the herbal composition. It also shows that the herbal pairs in the herbal composition provided by this invention exert a powerful therapeutic effect on CHF through synergistic effects, enhanced efficacy and reduced toxicity, and regulation of multiple targets. Each herbal pair in the formula is indispensable.

[0059] 4.3 Pathological observation results of heart tissue in each group of rats Figure 1 HE staining results of heart tissue from each group of rats, among which Figure 1 (a)- Figure 1 (d) The staining results of rats in the blank group, model group, positive control group and Example 1 group are shown in the figure. It can be seen from the figure that the myocardium of rats in the blank group is neatly and regularly arranged, the myocardial cells are uniform, and there is no obvious inflammatory cell infiltration. The myocardial cells of rats in the model group are disordered, and the myocardial cells are uneven in size and have some necrosis, with obvious inflammatory cell infiltration. Compared with the model group rats, the heart tissue of rats in the positive control group and Example 1 group is significantly improved, indicating that the traditional Chinese medicine composition provided by the present invention can significantly improve the myocardial tissue of rats.

[0060] In summary, the above animal experiments demonstrate that the traditional Chinese medicine composition provided by this invention has a significant therapeutic effect on rats with chronic heart failure. Furthermore, the drug pairs in the traditional Chinese medicine composition provided by this invention exert a powerful therapeutic effect on CHF through synergistic effects, enhanced efficacy and reduced toxicity, and regulation of multiple targets. Each drug pair in the formula is indispensable, thus demonstrating the unique compatibility advantages of the traditional Chinese medicine composition provided by this invention.

[0061] It should be noted that, in this document, terms such as “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0062] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating chronic heart failure, characterized in that, The composition consists of the following medicinal materials: processed aconite root, cinnamon twig, immature bitter orange, magnolia bark, pepper seeds, lepidium seed, poria cocos, akebia stem, codonopsis root, lily bulb, stir-fried cypress seed, ginger, white peony root, and achyranthes root.

2. The traditional Chinese medicine composition for treating chronic heart failure as described in claim 1, characterized in that, The composition consists of the following medicinal materials in parts by weight: 6-12 parts of processed aconite root, 6-12 parts of cinnamon twig, 6-10 parts of immature bitter orange, 6-10 parts of magnolia bark, 6-10 parts of pepper seeds, 10-15 parts of lepidium seed, 15-20 parts of poria cocos, 4-8 parts of akebia stem, 15-20 parts of codonopsis root, 10-15 parts of lily bulb, 10-15 parts of stir-fried arborvitae seed, 10-15 parts of fresh ginger, 15-20 parts of white peony root, and 10-15 parts of achyranthes root.

3. The traditional Chinese medicine composition for treating chronic heart failure as described in claim 1, characterized in that, The composition consists of the following medicinal materials in parts by weight: 9 parts prepared aconite root, 9 parts cinnamon twig, 8 parts immature bitter orange, 8 parts magnolia bark, 8 parts pepper seeds, 12 parts lepidium seed, 18 parts poria cocos, 5 parts akebia stem, 18 parts codonopsis root, 12 parts lily bulb, 12 parts stir-fried arborvitae seed, 12 parts fresh ginger, 18 parts white peony root, and 12 parts achyranthes root.

4. A method for preparing a traditional Chinese medicine composition for treating chronic heart failure, characterized in that, Includes the following steps: S1: Prepare a traditional Chinese medicine fluid extract from the traditional Chinese medicine composition according to any one of claims 1-3 for later use; S2: Add clinically acceptable excipients to the fluid extract of traditional Chinese medicine obtained in step S1, and prepare it using conventional formulation methods to produce a clinically acceptable oral traditional Chinese medicine preparation.

5. The method for preparing the traditional Chinese medicine composition for treating chronic heart failure as described in claim 4, characterized in that, The traditional Chinese medicine preparation is any one of the following: decoction, powder, pill, granule, capsule, tablet, drop pill, syrup, or oral liquid.

6. The method for preparing the traditional Chinese medicine composition for treating chronic heart failure as described in claim 4, characterized in that, S1 is prepared into a traditional Chinese medicine fluid extract using any one of the following methods: decoction concentration, percolation, maceration concentration, or reflux extraction concentration.

7. The method for preparing the traditional Chinese medicine composition for treating chronic heart failure as described in claim 6, characterized in that, In S1, when using the decoction and concentration method, the prepared aconite is decocted separately for 1-1.5 hours before adding the other medicinal materials, and the lepidium seed is decocted by wrapping it in a decocting method.

8. A traditional Chinese medicine preparation for treating chronic heart failure, characterized in that, The traditional Chinese medicine preparation is made using any one of the traditional Chinese medicine compositions according to claims 1-3 and clinically acceptable excipients in a conventional formulation manner.

9. The traditional Chinese medicine preparation for treating chronic heart failure as described in claim 8, characterized in that, The traditional Chinese medicine preparation is any one of the following: decoction, powder, pill, granule, capsule, tablet, drop pill, syrup, or oral liquid.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3, or the traditional Chinese medicine preparation prepared by any one of claims 4 to 7, or the traditional Chinese medicine preparation according to any one of claims 8 to 9, in the preparation of a medicament for treating chronic heart failure.

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