Traditional Chinese medicine composition for treating ejection fraction retention heart failure and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating ejection fraction retention heart failure and a preparation method thereof.The traditional Chinese medicine composition is prepared from, by weight, 15-30 parts of poria cocos, 10-25 parts of cassia twigs, 5-20 parts of rhizoma atractylodis macrocephalae, 15-30 parts of radix paeoniae rubra, 5-20 parts of radix aconiti carmichaeli and 5-20 parts of fructus corni. The preparation method specifically comprises four steps. The pharmaceutical composition disclosed by the invention is a pure traditional Chinese medicine preparation, has the multi-target effects of improving water metabolism in the body of a patient with heart failure, reversing myocardial remodeling, improving the heart function, improving the kidney function and the like, and has an excellent effect on the patient with advanced heart failure, especially the patient with ejection fraction retention and advanced heart failure.

Description

Technical Field

[0001] The present invention relates to the technical field of treating heart failure with preserved ejection fraction, and in particular to a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction and a preparation method thereof. Background Art

[0002] With the aging of the population, the incidence and mortality of heart failure with preserved ejection fraction (HFpEF) have been rising year by year, and it has become the main type of heart failure. However, the current treatment methods for HFpEF are very limited, especially for patients who have progressed to the late stage, whose quality of life is severely limited, and whose life safety is threatened at any time. Treatment options are even more scarce. Late-stage patients often face many difficult-to-solve bottlenecks: such as recurrent wheezing, intractable edema, diuretic resistance, severe shortage of heart transplant donors, and the high cost and high risk of replacement surgery, making the patient's prognosis extremely pessimistic. The repeated hospitalization rate and high mortality rate of patients pose severe challenges to clinical prevention and treatment management.

[0003] In this context, as an important alternative and complementary medical system, Traditional Chinese Medicine (TCM), with its holistic regulation and multi-target intervention characteristics, has demonstrated unique potential and value in improving symptoms of patients with advanced HFpEF, alleviating diuretic resistance, improving quality of life, reducing hospitalization rates, and improving long-term prognosis. Summary of the Invention

[0004] In response to the problem that the existing technology lacks effective treatment methods / drugs for patients with heart failure with preserved ejection fraction that has progressed to the late stage, the present invention provides a traditional Chinese medicine composition for treating late stage heart failure with preserved ejection fraction and a preparation method thereof.

[0005] The technical solution adopted in the present invention is as follows: A traditional Chinese medicine composition for treating heart failure with preserved ejection fraction comprises the following components in parts by weight: 15-30 parts of Poria cocos, 10-25 parts of cinnamon twigs, 5-20 parts of Atractylodes macrocephala, 15-30 parts of red peony root, 5-20 parts of aconite root and 5-20 parts of cornus fruit.

[0006] Preferably, the preparation comprises the following components in parts by weight: 20 parts of Poria cocos, 15 parts of cinnamon twig, 10 parts of Atractylodes macrocephala, 20 parts of red peony root, 10 parts of aconite root, and 10 parts of cornus fruit.

[0007] Preferably, the formula is composed of the following components by weight: 20g Poria, 15g Cinnamon Twig, 10g Atractylodes Macrocephala, 20g Red Peony Root, 10g Aconite, 10g Cornus Fruit. A method for preparing a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction comprises the following steps: S1: Weigh the Chinese medicinal materials according to any one of claims 1 to 3 and the proportion thereof; S2: drying and grinding the raw materials in step 1 into fine powder, sieving and setting aside; S3: Add an appropriate amount of refined honey to the fine powder obtained in step 2 and mix thoroughly to obtain a paste of appropriate hardness; S4: Form the paste obtained in step 3 into pills.

[0008] Preferably, the honey refined in S3 is vitex honey.

[0009] This application adopts the above technical solution, which has at least the following beneficial effects: 1. Ling Gui Qi Hua Formula No. 3, derived from the classic formula "Zhenwu Decoction" in Zhang Zhongjing's Treatise on Febrile Diseases, was developed through optimization and adaptation based on clinical experience. It consists of six traditional Chinese medicines: Poria cocos, cinnamon twig, Atractylodes macrocephala, red peony root, Cornus officinalis, and Aconitum carmichaelii. Over a decade of clinical observation, Ling Gui Qi Hua Formula No. 3 has been found to be highly effective in relieving clinical symptoms, improving cardiac function, and enhancing quality of life in patients with heart failure (HFpEF). A series of previous studies have thoroughly explored the mechanism of action and clinical efficacy of Ling Gui Qi Hua Formula No. 3 in the treatment of advanced HFpEF. This has important strategic and clinical implications for filling current treatment gaps and enriching therapeutic approaches. The traditional Chinese medicine composition disclosed in the present invention is prepared by adding and subtracting modifications on the basis of Zhenwu Decoction. On the basis of retaining the core therapeutic concept of the original prescription of warming yang and promoting diuresis, the invention takes into account the clinical manifestations of yang deficiency and yin deficiency in patients with late-stage heart failure caused by long-term illness, combined with the use of large doses of diuretics leading to dry mouth and tongue, and insufficient yin essence in patients. Cornus officinalis is added to nourish the liver and kidneys to seek yang in yin, and together with aconite, it replenishes both yin and yang; cinnamon twig is added to warm and invigorate the heart yang, calm the water vapor rushing against the lower burner, and prevent the water vapor from rushing to the heart and lungs.

[0010] 2. The technical solution of the present invention is based on the understanding of the pathogenesis and treatment principles of heart failure in traditional Chinese medicine, combined with modern disease classification and related pharmacological and pathological research, and is based on the formulation principles of harmonizing yin and yang, warming yang and transforming qi, strengthening the spleen and promoting diuresis, and promoting blood circulation and unblocking meridians.

[0011] 3. The pharmaceutical composition of the present invention is a pure traditional Chinese medicine preparation with multi-target effects, including improving water metabolism in patients with heart failure, reversing myocardial remodeling, enhancing cardiac function, and improving renal function. It is particularly effective for patients with advanced heart failure, especially those with preserved ejection fraction.

[0012] 4. The raw material ratio of the Chinese medicine composition of the present invention is 4:3:2:4:2:2:1 of Poria cocos: cinnamon twig: Atractylodes macrocephala: red peony root: aconite root: cornus fruit. The proper ratio can increase the efficacy of the prescription while controlling the toxicity of the drug.

[0013] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0015] Figure 1 is a comparison of the body weights of mice in each group in the experimental examples of the present invention; Figure 2 This is a comparison of the water drinking amount of mice in each group in the experimental example of the present invention; Figure 3 is a comparison of the 24-hour urine volume of each group of mice in the experimental examples of the present invention; Figure 4 is a comparison of the lung wet / dry weight ratios of the mice in each group in the experimental example of the present invention; Figure 5 Comparison of systolic blood pressure (left) and diastolic blood pressure (right) of mice in each group in the experimental example of the present invention; Figure 6 is a comparison of the running distances of the mice in each group in the experimental example of the present invention; Figure 7 is the cardiac ultrasound comparison of each group of mice in the experimental example of the present invention; Figure 8 is a comparison of the left ventricular weights of mice in each group in the experimental example of the present invention; Figure 9 is a comparison of the left ventricular posterior wall thickness at end diastole of each group of mice in the experimental example of the present invention; Figure 10 It is the cardiac function evaluation of each group of mice in the experimental examples of the present invention; Figure 11 These are the pathological changes in the heart and kidney of each group of mice in the experimental examples of the present invention. DETAILED DESCRIPTION

[0016] To make the objectives, technical solutions, and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other implementations obtained by those of ordinary skill in the art without inventive effort are within the scope of protection of the present invention.

[0017] First, the present invention discloses a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction. The composition comprises the following components, measured by weight: 15-30 parts of Poria cocos, 10-25 parts of Cinnamon twig, 5-20 parts of Atractylodes macrocephala, 15-30 parts of Red Peony Root, 5-20 parts of Aconite root, and 5-20 parts of Cornus officinalis. The monarch drugs are Aconite root and Cornus officinalis, the minister drug is Cinnamon twig, and the adjuvant drugs are Poria cocos, Atractylodes macrocephala, and Red Peony Root. The specific description is as follows: The main ingredients are aconite and cornus officinalis. Aconite is a key yang-boosting herb, entering the heart, spleen, and kidney meridians. Its pungent, sweet, and intensely hot properties dispel yin and cold, restoring the qi-transforming function of yang. Entering the kidneys, it warms and tonifies kidney yang, supporting the fire of the gate of life; entering the heart, it invigorates heart yang, reaching the lesion directly; and entering the spleen, it warms and regulates the middle earth, transforming dampness and water. Therefore, it is the core ingredient in the formula that warms yang and transforms qi. Cornus officinalis, with its sour, astringent, and slightly warm properties, nourishes the liver and kidneys, astringes, and consolidates. Combined with aconite, the combination of one warming and one astringing properties not only supports kidney yang but also prevents yang dissipation. It also seeks yang within yin, harmonizing yin and yang. Together, they serve as the main ingredients, aligning with the core pathogenesis of late-stage HFpEF, characterized by yang deficiency and water retention, combined with yin and yang deficiency.

[0018] The adjuvant herb is cinnamon twig, which enters the heart, lung, and bladder meridians, warming and invigorating heart yang, calming the downward pressure on adverse qi, and transforming qi and promoting the circulation of water. Its nature, which moves from the exterior to the interior, synergizes with aconite to enhance its warming yang effect, calming the upward surge of water vapor from the lower burner. It also guides the herb to the skin of the limbs, promoting the transformation of moisture into qi. It also clears the triple burner and bladder, aiding the distribution of fluids. This helps alleviate the secondary paradox of HFpEF patients, characterized by cold water invading the heart and lungs, causing heart and lung yang qi to stagnate, and causing internal retention of fluid.

[0019] The adjuvants are Poria cocos, Red Peony Root, and Atractylodes macrocephala. Poria cocos promotes diuresis and eliminates dampness, benefits the spleen and stomach, and calms the mind. It can guide accumulated dampness through urination and counteract the warming and drying effects of Aconite root and Cinnamon twig, preventing damage to Yin fluids. Atractylodes macrocephala strengthens the spleen and eliminates dampness, synergizing with Poria cocos to enhance the transport and transformation of the middle jiao, eliminating the source of dampness. It also assists Cinnamon twig and Aconite root in restoring the Yang Qi of the spleen and kidneys. Red Peony Root's blood-activating and stasis-removing effects prevent poor blood circulation caused by yang deficiency and water retention. Its slightly cold nature counteracts the warming and drying effects of the monarch and ministerial herbs, harmonizing their properties. Together, these three adjuvants assist the monarch and ministerial herbs in eliminating dampness, activating blood circulation, and strengthening the spleen, while also counteracting their warming and drying tendencies.

[0020] These six herbs, when used together, warm the yang and transform fluid, strengthen the spleen and nourish the heart, thereby strengthening yang qi, transforming fluid, and distributing body fluids. The formula combines warming yang with strengthening essence, harmonizing qi transformation with diuresis, and activating blood circulation and nourishing the heart, embodying the principles of "treating both blood and fluid," "harmony between yin and yang," and "both attacking and supplementing."

[0021] Preferably, the traditional Chinese medicine composition for treating heart failure with preserved ejection fraction of the present invention is composed of the following components in parts by weight: 20 parts of Poria cocos, 15 parts of cinnamon twig, 10 parts of Atractylodes macrocephala, 20 parts of red peony root, 10 parts of aconite root, and 10 parts of cornus fruit.

[0022] Preferably, the traditional Chinese medicine composition for treating heart failure with preserved ejection fraction of the present invention is composed of the following components by weight: 20g of Poria cocos, 15g of cinnamon twig, 10g of Atractylodes macrocephala, 20g of red peony root, 10g of aconite root, and 10g of cornus fruit.

[0023] The present invention discloses a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction, comprising Poria cocos, cinnamon twig, Atractylodes macrocephala, red peony root, aconite root, and cornus fruit. The components form a synergistic effect through complementary efficacy and harmonious medicinal properties. The core principle is to "harmonize yin and yang, warm yang and transform qi, strengthen the spleen and promote diuresis, and activate blood circulation and unblock meridians." The specific interaction mechanism between the components is as follows: 1. Internal coordination of the main medicine: warming yang and strengthening the foundation, mutual assistance of yin and yang Aconite's potent tonifying effect on the vital gate fire is the core driving force behind the formula's warming yang and transforming qi. Cornus officinalis's astringent and firming properties nourish the liver and kidneys, preventing the excessive warming and dispersing effects of aconite from damaging yang qi. The sour, astringent properties of Aconite counterbalance the pungent, dispersing properties of Aconite, creating a dynamic balance of "warming yang + consolidating," ensuring a sustained, uninterrupted warming and tonic effect. Together, they "seek yang within yin," fundamentally restoring the kidney's yang-transforming function while simultaneously strengthening and replenishing essence and qi, laying the foundation for therapeutic treatment.

[0024] 2. Synergy between the main and auxiliary drugs: warming the Yang, transforming Qi, and regulating the three burners Aconite (Prime Minister) and Cinnamon Twig (Minor): Aconite warms and nourishes kidney yang, fundamental for the generation of yang qi; cinnamon twig warms and unblocks heart yang, transforming qi and promoting water circulation, helping aconite to raise yang qi throughout the body. These two ingredients work together to "tonify kidney yang and unblock heart yang," replenishing yang qi deficiency and clearing blocked yang qi, providing sufficient power for the transformation of water and dampness and the circulation of qi and blood.

[0025] Cornus officinalis (Primary Ingredient) and Cinnamon Twig (Secondary Ingredient): Cornus officinalis’s sour, astringent properties nourish Yin and consolidate essence, preventing the pungent, dispersing properties of Cinnamon Twig from overly depleting Yang Qi. Cinnamon Twig, on the other hand, warms and promotes Yang, preventing Cornus officinalis from being too astringent and causing Qi stagnation. The combination of these two, one astringent and one unblocking, ensures the effects of warming Yang and transforming Qi while preventing the dissipation of Yang Qi.

[0026] Generally speaking, the monarch drugs (aconite root and cornus fruit) provide the basis for warming yang and consolidating the foundation, while the minister drugs (cinnamon twig) exert the activity of promoting yang and transforming qi, regulating the three burners, and jointly solving the core contradictions of yang deficiency, water retention, and unfavorable qi transformation.

[0027] 3. Cooperation of ministerial and adjuvant drugs: warming yang and strengthening spleen, promoting blood circulation and diuresis Cinnamon twig (minister) and Poria cocos (assistant): Cinnamon twig warms yang and transforms qi, promoting the vaporization of fluids; Poria cocos promotes diuresis and expels dampness through urination. This creates a dual dampness-eliminating pathway of "warming yang and transforming dampness + diuresis and expelling dampness," addressing both the symptoms and the root cause, enhancing fluid metabolism while preventing the re-accumulation of fluid.

[0028] Cinnamon twig (minister) and Atractylodes macrocephala (assistant): Cinnamon twig warms and promotes spleen yang, while Atractylodes macrocephala strengthens the spleen and dries away dampness, synergistically enhancing the transportation and transformation of spleen earth in the middle burner, reducing the formation of water and dampness from the source.

[0029] Cinnamon twig (minister) and red peony root (assistant): Cinnamon twig warms the meridians and unclogs the vessels, red peony root activates blood circulation and removes blood stasis, targeting poor blood circulation caused by yang deficiency and water retention, forming a "warming and promoting blood circulation + promoting blood circulation" combination; at the same time, the slightly cold nature of red peony root can counteract the warming and dryness of the monarch and minister drugs, forming a "warming and promoting blood circulation + harmonizing cold and heat" combination, avoiding damage to yin by warm and dryness.

[0030] In addition, the ministerial drug (cinnamon twig) acts as a "hub" to transmit the warming and yang-enhancing power of the monarch drug to the adjuvant drug, thereby achieving the secondary goals of strengthening the spleen and promoting diuresis (Poria cocos, Atractylodes macrocephala) and activating blood circulation (Red Peony Root).

[0031] Synergy among adjuvants: invigorating the spleen and drying dampness, removing blood stasis and promoting diuresis Poria (adjuvant) and Atractylodes (adjuvant): Poria is good at "peeling away dampness and promoting diuresis" (making dampness expel through urination), while Atractylodes is good at "strengthening the spleen and drying dampness" (reducing the formation of dampness). The two are a classic "strengthening the spleen and removing dampness" combination, forming a "combination of attack and supplement" dampness removal system.

[0032] Red Peony Root + Poria / Atractylodes: Red Peony Root invigorates blood circulation and improves blood stasis caused by stagnant water and dampness; Poria and Atractylodes strengthen the spleen and promote diuresis, reducing the obstruction of water and dampness to blood circulation.

[0033] The three herbs work together to resolve the complex pathogenesis of "blood and water co-morbidity." Poria and red peony root can balance the warming and drying properties of Atractylodes macrocephala, preventing excessive dryness from damaging yin, embodying the principle of "eliminating the properties while retaining the benefits."

[0034] The whole formula, through the rational combination of "warming yang (aconite root, cinnamon twig) + tonifying yin (cornus officinalis) + strengthening the spleen (poria cocos, white atractylodes) + promoting blood circulation (red peony root)", constructs a multi-level regulatory mechanism of "harmony of yin and yang, warming yang and transforming qi, strengthening the spleen and promoting diuresis, and promoting blood circulation and unblocking meridians". It is in line with the complex pathogenesis of HFpEF in the late stage of yang deficiency and water retention, weak essence and qi, and blood stasis, achieving a synergistic therapeutic effect of treating both the symptoms and the root causes, warming without drying, and tonifying without stagnation.

[0035] Secondly, the present invention discloses a method for preparing a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction, comprising the following steps: S1: Weigh the Chinese medicinal materials according to the ratio; S2: drying and grinding the raw materials in step 1 into fine powder, sieving and setting aside; S3: adding an appropriate amount of refined honey to the fine powder obtained in step 2, and mixing thoroughly to obtain a paste of appropriate hardness; wherein the refined honey can be vitex honey; S4: Form the paste obtained in step 3 into pills.

[0036] The following are specific experimental examples to illustrate the therapeutic effect of a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction disclosed in the present invention.

[0037] Prepare the materials: Drugs: Traditional Chinese medicine pieces were obtained from the pharmacy of Xiyuan Hospital, China Academy of Chinese Medical Sciences. The raw material pieces consisted of 20 g of Poria cocos, 15 g of Cinnamon twig, 10 g of Atractylodes macrocephala, 20 g of Red Peony Root, 10 g of Aconite root, and 10 g of Cornus officinalis. Poria cocos, Cinnamon twig, Atractylodes macrocephala, Red Peony Root, Aconite root, and Cornus officinalis were mixed in a ratio of 4:3:2:4:2:2, soaked for 30 minutes, and extracted twice with 120 ml of boiling water, each for 2 hours. The extracts were filtered, and the two filtrates were combined and subsequently evaporated to concentrate to 6 g / mL. Samples were stored at 4°C. Animals were administered doses of the distilled water extract of LGQH (i.e., the traditional Chinese medicine composition of the present invention) at 15 and 30 g / kg body weight.

[0038] Dapagliflozin No. TJ2031, AstraZeneca, UK; N-nitro-l-arginine methyl ester (L-NAME, Cat No. 51298-62-5, Cayman Chemical, USA); atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), serum creatinine (S-Cr) enzyme-linked immunosorbent assay (ELISA) kits; and blood urea nitrogen (BUN) biochemical assay kit (Cat No. 5296-5296, Shanghai ELISA Biotechnology Co., Ltd., ANP: ml105994, BNP: ml037594, S-Cr: mle42914, BUN: ml076479).

[0039] Animals: Male C57BL / 6J mice (SPF grade, 8 weeks old, 20 ± 2 g) were obtained from Huafukang (Beijing) Biological Science Co., Ltd. (Certificate: SCXK (Beijing) 2024-003, Beijing, China).

[0040] Methods and Results: Animals were housed in a pathogen-free environment (25°C, 50–60% relative humidity) at the Experimental Animal Center of Xiyuan Hospital, China Academy of Chinese Medical Sciences. This study was approved by the Animal Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences (approval number: 2023XLC024-3). The HFpEF (heart failure with preserved ejection fraction) mouse model was developed according to previous studies. After a one-week acclimation period, mice were randomly assigned to either a normal diet (ND) or a high-fat diet (HFD, 60% of calories from fat (lard)). The HFD group was given L-name (0.5 g / L in water) and maintained on the HFD until the end of the experiment; the ND group was given double-distilled water.

[0041] The specific groups and treatments were as follows: normal control group (CTRL group), model group (HFpEF-vehicle group), low-dose HLGQH group (HFpEF-LGQH-L group, 15 g / kg, equivalent dose), high-dose LGQH group (HFpEF-LGQH-H group, 30 g / kg, twice the equivalent dose), and dapagliflozin group (HFpEF-DAPA group, 1.76 g / kg). Mice were gavaged daily for two weeks. Body weight, water intake, urine output, and mental status were observed daily. Blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) was measured in awake mice using noninvasive tail-cuff plethysmography, and exercise exhaustion testing was performed. Echocardiographic assessments were performed under isoflurane-induced anesthesia. Biological samples collected included whole blood, heart, lung, and kidney tissue.

[0042] Throughout the experiment, all groups remained in good health, indicating that LGQH was safe and well tolerated at the doses administered. Body weight and water intake were monitored for all cohorts throughout the 2-week treatment period. The baseline body weight of HFpEF mice was significantly higher than that of normal control mice (CTRL). On day 4 of treatment, the body weight of HFpEF mice treated with high-dose LGQH (HFpEF-LGQH-h) was significantly lower than that of HFpEF mice not treated with LGQH (HFpEF-vehicle). Starting on day 6, the body weight difference between mice treated with LGQH or DAPA (positive control drug) and the HFpEF vehicle group remained statistically significant and persisted throughout the treatment period. There was no statistical difference in water intake between the groups. For details, please see Figure 1 and Figure 2 .

[0043] See Figure 3 Quantitative evaluation of the 24-h urine volume of mice showed that the diuretic volume of mice treated with LGQH (the Chinese medicine composition of the present invention) or DAPA (dapagliflozin) was significantly increased compared with the blank control group and the model group.

[0044] See Figure 4 The lung wet-to-dry weight ratio of HFpEF mice was significantly increased compared with the control group (P<0.01), and LGQH treatment significantly attenuated this pathophysiological parameter.

[0045] Taken together, these findings suggest that LGQH may improve tissue edema in HFpEF by enhancing fluid clearance mechanisms. In addition, both systolic and diastolic blood pressure were significantly increased in the HFpEF group compared with the CTRL group. High-dose LGQH treatment significantly attenuated the elevated blood pressure in HFpEF mice. Figure 5 .

[0046] See Figure 6 , exercise tolerance test showed that the running distance of HFpEF mice was significantly reduced compared with the control group, while both LGQH-H and DAPA treatment effectively restored exercise capacity.

[0047] See Figures 7 to 10 , cardiac structural analysis showed LVPWd (see Figure 7 Upper part and Figure 9 ) and LVmass (see Figure 8 ) significantly increased. High-dose LGQH and DAPA treatment can effectively reverse the above pathological changes. Cardiac function assessment (see Figure 7 Lower part and Figure 10 ) showed that diastolic dysfunction parameters, including E / A ratio and E / E′ ratio, were impaired in HFpEF mice, and the diastolic dysfunction parameters in the LGQH and dapagliflozin treatment groups were significantly attenuated.

[0048] See Figure 11 H&E staining of heart sections showed that compared with CTRL group mice, HFpEF mice showed characteristic cardiac pathology, including ventricular dilatation, left ventricular wall thickening, cardiomyocyte hypertrophy, myofibril disorganization, interstitial dilatation and inflammatory infiltration (see details). Figure 11 AB). Both LGQH and DAPA treatment alleviated these pathological changes, with high-dose LGQH showing a particularly significant effect in normalizing cardiac morphology. In addition, serum biomarker analysis showed that ANP and BNP levels were significantly elevated in HFpEF-Vehicle mice, consistent with disease progression. LGQH and DAPA treatment significantly reduced both conditions (see Figure 11 G). Masson trichrome staining of cardiac sections confirmed that HFpEF mice had increased interstitial and perivascular fibrosis compared with normal mice, as evidenced by increased collagen deposition (CVF and PFR), while LGQH significantly improved myocardial fibrosis (see Figure 11 CD and H).

[0049] Renal H&E staining showed structural abnormalities in HFpEF mice, including interstitial hyperplasia, tubular dilatation, and glomerular atrophy. LGQH treatment ameliorated these structural abnormalities (see Figure 11 E). Masson staining further demonstrated extensive collagen deposition in the renal tissues of HFpEF mice. LGQH treatment effectively alleviated fibrotic remodeling (see Figure 11 F). Biochemical analysis showed that LGQH and DAPA treatment significantly reduced the elevated S-Cr and BUN levels in HFpEF mice (see Figure 11I). These results indicate that LGQH can ameliorate cardiac and renal pathological changes in HFpEF mice, suggesting its potential in alleviating cardiorenal syndrome.

[0050] Based on this, it can be seen that the traditional Chinese medicine composition for treating heart failure with preserved ejection fraction disclosed in the present invention has a significant effect in treating heart failure with preserved ejection fraction.

[0051] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A Chinese medicine composition for treating heart failure with preserved ejection fraction, characterized in that: The invention is composed of the following components in parts by weight: 15-30 parts of Poria cocos, 10-25 parts of cinnamon twig, 5-20 parts of Atractylodes macrocephala, 15-30 parts of red peony root, 5-20 parts of aconite root and 5-20 parts of cornus fruit.

2. The Chinese medicine composition according to claim 1, characterized in that The invention is composed of the following components in parts by weight: 20 parts of Poria cocos, 15 parts of cinnamon twig, 10 parts of Atractylodes macrocephala, 20 parts of red peony root, 10 parts of aconite root and 10 parts of cornus fruit.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: Calculated by weight in grams, it is composed of the following components: 20g of Poria cocos, 15g of cinnamon twig, 10g of Atractylodes macrocephala, 20g of red peony root, 10g of Aconitum carmichaelii, and 10g of Cornus officinalis.

4. A method for preparing a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction, characterized in that: The following steps are involved: S1: Weigh the Chinese medicinal materials according to any one of claims 1 to 3 and the proportion thereof; S2: drying and grinding the raw materials in step 1 into fine powder, sieving and setting aside; S3: Add an appropriate amount of refined honey to the fine powder obtained in step 2 and mix thoroughly to obtain a paste of appropriate hardness; S4: Form the paste obtained in step 3 into pills.

5. The preparation method according to claim 4, characterized in that The honey refined in step 3 is honeysuckle honey.

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