Traditional Chinese medicine composition for preventing and treating chronic heart failure and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for preventing and treating chronic heart failure. The traditional Chinese medicine composition comprises the following components in parts by weight: 20-30 parts of astragalus membranaceus, 10-20 parts of red ginseng, 5-10 parts of cinnamon, 5-10 parts of bighead atractylodes rhizome, 10-20 parts of radix ophiopogonis, 10-20 parts of poria cocos, 10-20 parts of radix paeoniae alba, 5-10 parts of schisandra chinensis and 5-10 parts of liquorice. According to the traditional Chinese medicine composition for preventing and treating chronic heart failure, the heart failure symptoms are improved by tonifying qi of the spleen, the lung, the heart and the kidney, warming yang, transforming fluid retention, consolidating yin and treating both symptoms and root causes. The traditional Chinese medicine composition for preventing and treating chronic heart failure provided by the invention can be used for medicated food.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for the prevention and treatment of chronic heart failure and its application. Background Technology

[0002] Chronic heart failure (CHF) is the end stage of various cardiovascular diseases, with a global prevalence of 2%-3%. Patients often experience myocardial energy metabolism disorders, water and sodium retention, and systemic inflammatory responses. Western medicine defines it as a clinical syndrome caused by abnormalities in cardiac structure or function, resulting in reduced cardiac output and obstructed venous return. The core diagnostic criteria are elevated NT-proBNP and decreased LVEF, emphasizing the pathological mechanisms of neuroendocrine activation and ventricular remodeling. Traditional Chinese medicine (TCM), on the other hand, categorizes it under "palpitation," "dyspnea," and "edema," believing that its pathogenesis lies in the deficiency of heart qi (yang) as the root cause, accompanied by blood stasis, fluid retention, and phlegm turbidity as manifestations. It emphasizes the overall imbalance of the "five internal organs" and uses the four diagnostic methods (inspection, auscultation and olfaction, inquiry, and palpation) for syndrome differentiation (e.g., heart and kidney yang deficiency, qi and yin deficiency). Traditional Western medicine primarily uses medications such as diuretics (e.g., furosemide), angiotensin-converting enzyme inhibitors (e.g., enalapril), beta-blockers (e.g., metoprolol), and aldosterone antagonists (e.g., spironolactone) to improve cardiac function, alleviate symptoms, and reduce mortality; in severe cases, positive inotropic drugs (e.g., digoxin) may also be used. Traditional Chinese medicine, on the other hand, is based on syndrome differentiation and treatment, frequently using qi-tonifying and blood-activating (e.g., astragalus and salvia miltiorrhiza) and yang-warming and diuretic (e.g., aconite and poria) medications and formulas (e.g., Shengmai San and Zhenwu Tang) to emphasize adjusting the overall yin-yang balance. Both have their own characteristics, and modern medicine is exploring their combined use to optimize therapeutic effects.

[0003] In recent years, traditional Chinese medicine (TCM) dietary therapy has gained increasing attention as an adjunct treatment for chronic heart failure (CHF) due to its unique "medicine and food from the same source" concept and holistic regulatory advantages. It has been formally included in the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure" as an important supplementary treatment method. Its advantages include: ① gentle and long-lasting effects, avoiding common side effects of Western medicine such as electrolyte imbalances; ② improved long-term patient compliance through dietary means; ③ excellent cost-effectiveness, suitable for long-term chronic disease management; ④ alignment with the "prevention before disease" concept, allowing intervention as early as stage A of heart failure. Based on the principles of TCM syndrome differentiation and treatment, dietary therapy scientifically combines food and medicinal herbs to leverage both the nutritional benefits of food and the therapeutic effects of medicine, achieving a synergistic effect of "treatment within nourishment." Studies have shown that the rational application of dietary therapy can significantly improve patients' cardiac function classification (e.g., NYHA classification), reduce serum BNP / NT-proBNP levels, and demonstrate unique advantages in regulating water and sodium metabolism, reducing cardiac load, and improving myocardial energy metabolism. Compared to chemical drugs, medicinal diet therapy has the advantages of mild effects, fewer adverse reactions, and high patient compliance. It is especially suitable for patients with chronic heart failure who require long-term management. Through mechanisms such as invigorating qi and blood circulation, and promoting diuresis and dampness elimination, it provides a safe and effective nutritional intervention program and has demonstrated important supplementary therapeutic value in clinical practice.

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of chronic heart failure, which can be used as a raw material for medicinal diets. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for the prevention and treatment of chronic heart failure, which improves various symptoms of heart failure by tonifying the qi of the spleen, lungs, heart and kidneys, warming yang and resolving phlegm, and consolidating yin fluids.

[0006] The first aspect of the present invention is to provide a traditional Chinese medicine composition for the prevention and treatment of chronic heart failure, comprising the following components in parts by weight:

[0007] Astragalus membranaceus 20-30 parts, red ginseng 10-20 parts, cinnamon 5-10 parts, atractylodes macrocephala 5-10 parts, ophiopogon japonicus 10-20 parts, poria cocos 10-20 parts, white peony root 10-20 parts, schisandra chinensis 5-10 parts, licorice root 5-10 parts.

[0008] Furthermore, the ingredients are: Astragalus membranaceus 25 parts, Red ginseng 15 parts, Cinnamomum cassia 10 parts, Atractylodes macrocephala 8 parts, Ophiopogon japonicus 15 parts, Poria cocos 15 parts, Paeonia lactiflora 15 parts, Schisandra chinensis 10 parts, and Glycyrrhiza uralensis 8 parts.

[0009] A second aspect of the present invention is to provide the application of the traditional Chinese medicine composition as described in the first aspect in medicinal cuisine.

[0010] Furthermore, the medicinal cuisine is one of the following: medicinal steamed rice, medicinal porridge, medicinal rice paste, medicinal steamed buns, medicinal pastries, medicinal soup, medicinal tea eggs, or medicinal tea drinks.

[0011] Compared with the prior art, the traditional Chinese medicine composition for the prevention and treatment of chronic heart failure provided by the present invention has the following beneficial effects:

[0012] I. The traditional Chinese medicine composition for the prevention and treatment of chronic heart failure provided by this invention uses Astragalus membranaceus and red ginseng as the principal herbs, cinnamon and Atractylodes macrocephala as the assistant herbs, Ophiopogon japonicus, Poria cocos, Paeonia lactiflora and Schisandra chinensis as the adjuvant herbs, and Glycyrrhiza uralensis as the guiding herb. The whole formula integrates the methods of tonifying qi and warming yang, and promoting diuresis and nourishing yin. It not only follows the principle of "tonifying the weak" in the "Inner Canon of Medicine", but also conforms to the modern understanding of heart failure as "qi, blood and water are all affected". By tonifying the qi of the spleen, lungs, heart and kidneys, warming yang and transforming phlegm, and consolidating yin fluid, it addresses both the root cause and the symptoms of heart failure.

[0013] II. The traditional Chinese medicine composition for the prevention and treatment of chronic heart failure provided by this invention can be used as a raw material in medicinal cuisine, and has the characteristics of mild effects, few adverse reactions, and high patient compliance. Detailed Implementation

[0014] To enable those skilled in the art to better understand the technical solutions in the embodiments of the present invention, and to make the above-mentioned objectives, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be further described below.

[0015] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein.

[0016] The traditional Chinese medicine composition of the present invention for the prevention and treatment of chronic heart failure comprises the following components in parts by weight:

[0017] Astragalus membranaceus 20-30 parts, red ginseng 10-20 parts, cinnamon 5-10 parts, atractylodes macrocephala 5-10 parts, ophiopogon japonicus 10-20 parts, poria cocos 10-20 parts, white peony root 10-20 parts, schisandra chinensis 5-10 parts, licorice root 5-10 parts.

[0018] Principal herbs: Astragalus membranaceus, Red ginseng

[0019] This formula uses Astragalus membranaceus and red ginseng as the principal herbs. Astragalus membranaceus is slightly warm in nature and sweet in taste. It enters the spleen and lung meridians and has the effects of tonifying qi and consolidating the exterior, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting pus drainage and detoxification, and promoting wound healing and tissue regeneration. The "Shennong's Classic of Materia Medica" states that Astragalus membranaceus "tonifies deficiency," that is, it tonifies the deficiency of vital qi. The "Compendium of Materia Medica" states that it is "a medicine that tonifies the lungs and strengthens the spleen, strengthens the defensive qi and astringes sweat, and dispels wind and detoxifies." Zhang Yuansu said that "Astragalus membranaceus is sweet, warm, and purely yang, and its uses are fivefold: first, to tonify various deficiencies; second, to benefit the original qi; third, to strengthen the spleen and stomach; fourth, to remove heat from the muscles; and fifth, to drain pus, relieve pain, and promote blood circulation and blood generation." The "Records of Integrating Chinese and Western Medicine" further details that it "can tonify qi and also raise qi, and is good at treating qi sinking in the chest," which is exactly what is needed for qi deficiency and shortness of breath in heart failure. Li Dongyuan said that "Astragalus membranaceus tonifies the three jiaos and strengthens the defensive qi, with the same effect as cinnamon, and is especially superior." "The difference between cinnamon and astragalus is that it is sweet and neutral, not pungent or hot," indicating its function of tonifying qi and raising yang, making it most suitable for qi deficiency and sinking due to heart failure. The *Compendium of Materia Medica* states that "(Astragalus) makes yang qi harmonious and smooth, full and flowing... naturally without stagnation." The *Compendium of Materia Medica* records that "although its nature is warm and tonifying, it can regulate blood vessels and flow through the meridians, without hindering stagnation." Both indicate that astragalus not only tonifies qi and nourishes blood but also has the effect of clearing blood vessels, allowing qi and blood to flow smoothly throughout the body, tonifying without stagnation, which is what Luo Mei referred to as "a tonic for stroke." Red ginseng is warm in nature, sweet and slightly bitter in taste, and enters the spleen, lung, heart, and kidney meridians. It has the effects of greatly tonifying primordial qi, restoring pulse and consolidating the body, and benefiting qi and controlling blood. Red ginseng is made by steaming ginseng. The *Compendium of Materia Medica* states that "steamed ginseng turns black, which is red ginseng; it is warm and nourishing." It has a sweet and slightly bitter taste and is warm in nature. The *New Compilation of Materia Medica* says that red ginseng "greatly replenishes vital energy, generates yin and blood, and strengthens the spleen and stomach." Chen Shiduo's *New Compilation of Materia Medica* details that red ginseng "can restore vital energy from near depletion and replenish the yang energy of the five internal organs." Zhang Xichun said that "red ginseng is potent and can restore yang in an instant." Its warming and nourishing power is more pronounced than that of white ginseng. The *Depei Materia Medica* clearly states that "red ginseng is warm in nature, greatly replenishes vital energy, and is most suitable for deficiency and cold syndromes." The two complement each other; astragalus replenishes qi and raises yang, while red ginseng warms and replenishes vital energy, working together to replenish qi, consolidate the body, warm yang, and restore the pulse. Red ginseng is particularly effective in treating "profuse sweating and loss of yang, with a weak and almost imperceptible pulse" (from "Essentials of Materia Medica"). Astragalus is excellent at "lifting and raising the sunken qi" (from "Records of Integrating Chinese and Western Medicine"). The combined effect of these two herbs restores the yang qi of heart failure and raises the qi, thus calming the wheezing and relieving palpitations. They are truly essential medicines for treating heart failure with deficiency and cold syndrome.

[0020] Assistant herbs: Cinnamon, Atractylodes macrocephala

[0021] Cinnamon is extremely hot in nature, pungent and sweet in taste, and enters the kidney, spleen, heart, and liver meridians. It has the effects of tonifying fire and assisting yang, dispelling cold and relieving pain, warming the meridians and unblocking the vessels, and guiding fire back to its origin. The *Jingyue Quanshu* states that cinnamon is hot in nature and good at assisting yang, especially entering the blood level. For those with cold ailments in the limbs, nothing else can reach them. Furthermore, cinnamon has a strong flavor, thus it can warm and tonify the kidney, strengthen tendons and bones, unblock blood vessels, and treat cold in the heart and abdomen, headache, cough, nasal congestion, cholera with muscle spasms, pain in the waist, feet, navel, and abdomen, and all kinds of chronic cold and stubborn diseases. *Ben Cao Qiu Zhen* states that it "can guide fire back to its origin and unblock the orifices," and Zhang Yuansu said it "tonifies the deficiency of the lower burner and treats chronic cold and stubborn diseases," especially good at treating "heart pain and hypochondriac wind" (*Ben Cao Jing Ji Zhu*), which is precisely for the syndrome of heart failure and deficiency of heart and kidney yang. Atractylodes macrocephala is warm in nature, sweet and bitter in taste, and enters the spleen and stomach meridians. It has the effects of strengthening the spleen, replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. The *Jingyue Quanshu* states that it is sweet and pungent in taste, warm in nature, and rich in flavor and aroma. It can ascend and descend, containing both yin and yang, and blood within qi. Its warm and dry nature allows it to benefit qi and harmonize the middle jiao, replenish yang and generate blood, warm the stomach and aid digestion, benefit body fluids, build muscle, boost spirit, strengthen the spleen and stomach, stop vomiting, replenish fatigue, improve appetite, promote urination, eliminate dampness and phlegm, reduce bloating and distension, and treat cold pain in the heart and abdomen, diarrhea due to stomach deficiency, and abdominal masses. The *Ben Cao Jing Jie* states that "Atractylodes macrocephala is warm in nature, sweet and bitter in taste, and treats wind-cold-dampness arthralgia, dead muscle spasms, jaundice, stops sweating, eliminates heat, and aids digestion." Its effects of "eliminating dampness and benefiting dryness, harmonizing the middle jiao and benefiting qi" (*Yixue Qiyuan*) can alleviate symptoms of heart failure, spleen deficiency, and dampness. The Compendium of Materia Medica states that "Atractylodes macrocephala is bitter and sweet, and can both dry dampness and strengthen the spleen, as well as soothe the spleen and generate fluids. Moreover, it is the warmest in nature, and taking it can help to improve digestion and eliminate food. It is the first essential medicine for replenishing the spleen and qi." The Compendium of Materia Medica states that "no other medicine can surpass Atractylodes macrocephala in replenishing the spleen and stomach." The two work together as the chief medicine to warm yang and assist qi.

[0022] Adjuvant herbs: Ophiopogon japonicus, Poria cocos, Paeonia lactiflora, Schisandra chinensis

[0023] Ophiopogon japonicus is slightly cold in nature, sweet and slightly bitter in taste, and enters the heart, lung, and stomach meridians. It has the effects of nourishing yin and moistening the lungs, benefiting the stomach and promoting fluid production, and clearing the heart and relieving irritability. The *Ben Cao Fen Jing* states that it "moistens the lungs and clears the heart, drains heat and relieves irritability, and treats latent fire in the lungs," and can counteract the warming and drying effects of ginseng and cinnamon while also nourishing yin. Poria cocos is neutral in nature, sweet and bland in taste, and enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind. The *Ming Yi Bie Lu* states that it stops thirst, excessive salivation, abdominal distension with dribbling, phlegm in the diaphragm, edema, and urinary retention; it opens the chest, regulates the internal organs, eliminates kidney evil, nourishes yin, strengthens qi, and protects the spirit. The rooted variety is called *Fu Shen*. The *Ben Cao Yan Yi* states that "Poria cocos and *Fu Shen* have many diuretic effects, and their benefits to the heart and spleen are indispensable," precisely treating heart failure with water retention affecting the heart. White peony root is slightly cold in nature, bitter and sour in taste, and enters the liver meridian. It has the effects of nourishing blood and astringing yin, softening the liver and relieving pain, and calming liver yang. The *Pharmacopoeia of Medicinal Properties* states that it can both ascend and descend, and is of the Yang nature. Its uses are fourfold: it supports Yang Qi and greatly relieves abdominal pain; it astringes Yin Qi and strengthens the spleen meridian; it can induce abortion and expel blood stasis; it can soothe the liver and relieve internal stagnation. The *Shennong's Classic of Materia Medica* states that it treats abdominal pain caused by pathogenic factors, removes blood stasis, breaks up hard masses, treats chills and fever, hernia, relieves pain, promotes urination, and benefits Qi. Schisandra chinensis is warm in nature, sour and sweet in taste, and enters the lung, heart, and kidney meridians. It has astringent, Qi-boosting, fluid-generating, kidney-tonifying, and heart-calming effects. The *Shennong's Classic of Materia Medica* states that it "primarily benefits Qi, treats cough and shortness of breath, treats fatigue and emaciation, replenishes deficiencies, strengthens Yin, and benefits male essence." The *Essentials of Materia Medica* further details that it is "warm in nature, possessing all five flavors, with sour and salty being the most prevalent; therefore, it specifically astringes lung Qi and nourishes kidney water, boosts Qi and generates fluids, replenishes deficiency and improves eyesight, strengthens Yin and astringes essence, reduces fever and stops sweating, stops vomiting and diarrhea, calms cough and asthma, and relieves thirst." In this treatment, its combination with red ginseng and ophiopogon japonicus implicitly embodies the principles of Shengmai San (a traditional Chinese medicine formula). The *Yifang Jijie* states that "ginseng is sweet and warm, greatly tonifying lung qi as the chief herb; ophiopogon japonicus is sweet and cold, moistening the lungs and nourishing water as the assistant herb; schisandra chinensis is sour and warm, astringing the lungs and generating fluids as the adjuvant herb." The combination of these three herbs replenishes qi and restores pulse, precisely treating the symptoms of heart failure with shortness of breath and wheezing. Its astringent nature can astringe sweat and prevent collapse. The *Yongyao Faxiang* states that it "absorbs lung qi, replenishes deficiencies, strengthens yin and benefits essence," preventing excessive sweating and yang depletion in heart failure patients. The *Bencao Jing Shu* says that "its main function is to benefit qi, as the lungs govern all qi; sourness astringes, thus entering the lungs to tonify them." By astringing the floating qi, it can help calm the wheezing and shortness of breath in heart failure patients. Especially when combined with cinnamon in the formula, one astringent and the other warming, the yang qi is both warmed and tonified without floating, perfectly aligning with the *Neijing*'s principle of "generating qi with gentle fire." Zhang Yuansu once said that "Schisandra chinensis astringes lung qi and is an essential medicine for treating heat and fire." Li Gao further stated that "taking Shengmai San in summer, with the addition of Astragalus membranaceus and Glycyrrhiza uralensis, can make one's qi and strength surge forth." It can be seen that when Schisandra chinensis is combined with ginseng and Astragalus membranaceus, it is most effective in replenishing qi and consolidating the body, and is especially useful for those with heart failure who experience shortness of breath, spontaneous sweating, and a weak and almost imperceptible pulse.

[0024] Medicinal herb: Licorice

[0025] Licorice is neutral in nature and sweet in taste. It enters the heart, lung, spleen, and stomach meridians and has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing the properties of other herbs. It can replenish heart qi and restore the pulse. At the same time, it is good at entering the middle jiao to tonify the spleen and replenish qi. The "Ben Cao Zheng" states that it "assists ginseng and astragalus in achieving the effect of qi deficiency."

[0026] Therefore, this formula integrates the methods of tonifying qi and warming yang, and promoting diuresis and nourishing yin. It not only follows the principle of "tonifying the weak" in the "Inner Canon of Medicine", but also conforms to the modern understanding of heart failure as "qi, blood and water are all affected". By tonifying the qi of the spleen, lungs, heart and kidneys, warming yang and transforming phlegm, and consolidating yin fluid, it addresses both the root cause and the symptoms of heart failure.

[0027] Modern pharmacological research:

[0028] (1) Astragalus: Studies combining traditional Chinese and Western medicine have confirmed that Astragalus has significant effects in invigorating qi and promoting blood circulation in the treatment of chronic heart failure (CHF). Clinical studies in traditional Chinese medicine have shown that classic compound formulas containing Astragalus (such as Buyang Huanwu Decoction and Astragalus Shengmai Decoction) can significantly improve the cardiac function classification and quality of life of heart failure patients. A multicenter study published in the Chinese Journal of Integrated Traditional and Western Medicine in 2023 showed that Astragalus injection combined with conventional Western medicine treatment increased the LVEF of CHF patients by 6.2% (p<0.01) and increased the 6-minute walking distance by 51.3 meters. Modern pharmacological studies have revealed that the main active components of Astragalus, astragaloside A and Astragalus polysaccharides, improve myocardial energy metabolism by activating the SIRT1 / AMPK / PGC-1α pathway (Phytomedicine 2023), while inhibiting the TGF-β1 / Smad3 signaling pathway to reduce myocardial fibrosis (Journal of Ethnopharmacology 2022), and can enhance myocardial contractility by regulating the PI3K / Akt / eNOS pathway. Animal experiments have shown that Astragalus extract can reduce the apoptosis rate of cardiomyocytes in rats with heart failure by 45.6% (Frontiers in Pharmacology, 2023), and its mechanism is related to the upregulation of the Bcl-2 / Bax ratio. A meta-analysis published in the Journal of the American College of Cardiology in 2023 indicated that Astragalus-containing preparations can reduce all-cause mortality by 31% in the treatment of CHF (RR=0.69, 95% CI: 0.57-0.83).

[0029] (2) Red Ginseng: Existing integrated traditional Chinese and Western medicine research has confirmed that red ginseng exhibits multifaceted pharmacological activities in the treatment of chronic heart failure (CHF). Clinical research in traditional Chinese medicine has shown that compound prescriptions containing red ginseng (such as Shengmai San and Shenfu Tang) can significantly improve the cardiac function classification and quality of life of heart failure patients. Among them, a multicenter study published in the Chinese Journal of Integrated Traditional and Western Medicine in 2022 showed that Shengmai San combined with conventional Western medicine treatment increased the 6-minute walking distance of CHF patients by 42.5 meters (p<0.01), and the improvement rate of the Minnesota Heart Failure Quality of Life Score reached 68.3%. Modern pharmacological research reveals that the main active ingredients of red ginsenosides (such as Rg1 and Rb1) enhance myocardial cell energy metabolism by activating the AMPK / mTOR pathway, while inhibiting NADPH oxidase to reduce ROS generation (Journal of Ginseng Research 2021), and can regulate calmodulin expression to improve myocardial contractility. Animal experiments have confirmed that red ginseng extract can increase left ventricular ejection fraction by 11.7% in rats with heart failure (Phytomedicine 2020), and its mechanism is related to the downregulation of the TGF-β1 / Smad3 pathway to inhibit myocardial fibrosis. Notably, a meta-analysis published in Frontiers in Cardiovascular Medicine in 2023 indicated that red ginseng preparations can reduce BNP levels in CHF patients by 28.4% (95% CI: -36.2 to -20.6).

[0030] (3) Cinnamon: Integrated traditional Chinese and Western medicine research has confirmed that cinnamon has unique warming and blood-activating effects in the treatment of chronic heart failure (CHF). Clinical research in traditional Chinese medicine has shown that compound prescriptions containing cinnamon (such as Shenfu Decoction and Yougui Pill) can significantly improve the clinical symptoms of patients with heart and kidney yang deficiency type heart failure. A randomized controlled trial published in the Chinese Journal of Traditional Chinese Medicine in 2022 showed that the total effective rate of cinnamon-containing prescriptions in the treatment of CHF patients reached 83.6%, and it could increase the 6-minute walking distance (42.8 meters, p<0.05). Modern pharmacological research reveals that the main active components of cinnamon, cinnamaldehyde and cinnamon polyphenols, improve myocardial microcirculation by activating the PI3K / Akt / eNOS signaling pathway (Journal of Ethnopharmacology 2023), while inhibiting NADPH oxidase activity to reduce oxidative stress (Oxidative Medicine and Cellular Longevity 2021), and can regulate L-type calcium channels to enhance myocardial contractility. Animal experiments have confirmed that cinnamon extract can increase myocardial ATP content in heart failure rats by 38.2% (Phytomedicine 2022), and its mechanism is related to the activation of the AMPK / PGC-1α energy metabolism pathway. A systematic review in Frontiers in Cardiovascular Medicine in 2023 indicated that warming yang formulas containing cinnamon can reduce NT-proBNP levels in CHF patients by 26.4% (95% CI: -32.1 to -20.7).

[0031] (4) Atractylodes macrocephala: Studies combining traditional Chinese and Western medicine have shown that Atractylodes macrocephala exhibits multi-target regulatory effects in the treatment of chronic heart failure (CHF). Clinical studies in traditional Chinese medicine have confirmed that classic compound formulas containing Atractylodes macrocephala (such as Linggui Zhugan Decoction and Zhenwu Decoction) can significantly improve symptoms such as edema and fatigue in heart failure patients. A study published in the Chinese Journal of Integrated Traditional and Western Medicine in 2021 showed that Linggui Zhugan Decoction combined with conventional Western medicine treatment can increase the 6-minute walking distance of CHF patients by 38.6 meters (p<0.05) and reduce NT-proBNP levels. Modern pharmacological studies have revealed that the main active components of Atractylodes macrocephala, atractylodes lactone I and III and polysaccharides, can reduce cardiac load by inhibiting excessive activation of the RAAS system (Journal of Ethnopharmacology 2022), regulate the expression of AQP-2 aquaporin to promote diuresis (Phytomedicine 2023), and downregulate the TGF-β1 / Smad3 pathway to inhibit myocardial fibrosis. Experimental studies have shown that Atractylodes macrocephala extract can reduce myocardial collagen content in heart failure rats by 29.4% (Frontiers in Pharmacology, 2023), and its mechanism is related to its antioxidant stress (increasing SOD activity) and anti-inflammatory (inhibiting NF-κB) effects. A meta-analysis published in the Chinese Journal of Integrative Medicine in 2023 indicated that the overall effective rate of Atractylodes macrocephala-containing compound treatment for CHF was 24.8% higher than that of the control group (OR=1.89, 95%CI: 1.45-2.47).

[0032] (5) Ophiopogon japonicus: Studies combining traditional Chinese and Western medicine have shown that Ophiopogon japonicus has significant pharmacological activity in the treatment of chronic heart failure (CHF). Clinical studies in traditional Chinese medicine have shown that classic compound formulas containing Ophiopogon japonicus (such as Shengmai San and Tianwang Buxin Dan) can effectively improve the symptoms of Qi and Yin deficiency in heart failure patients. A randomized controlled trial published in the Chinese Journal of Traditional Chinese Medicine in 2021 confirmed that Shengmai San combined with conventional Western medicine treatment can increase the left ventricular ejection fraction (LVEF) of CHF patients by 4.8% and significantly reduce NT-proBNP levels (p<0.01). Modern pharmacological studies have revealed that the main active components of Ophiopogon japonicus, such as saponins, polysaccharides and high isoflavones, can inhibit cardiomyocyte apoptosis by regulating the PI3K / Akt / mTOR signaling pathway (Journal of Ethnopharmacology 2022), while enhancing SOD activity and reducing oxidative stress damage (Phytomedicine 2020). Experimental studies have also found that Ophiopogon japonicus extract can downregulate the NF-κB inflammatory pathway, reduce the release of TNF-α and IL-6 (Frontiers in Pharmacology 2023), and improve myocardial energy metabolism disorders. Notably, a meta-analysis published in Chinese Medicine in 2023 indicated that traditional Chinese medicine compound formulas containing Ophiopogon japonicus can increase the 6-minute walking distance of CHF patients by 35.2 meters (95% CI: 21.4-49.0).

[0033] (6) Poria: Existing research combining traditional Chinese and Western medicine shows that Poria and its compound formulas have multi-target intervention effects in the treatment of chronic heart failure (CHF). Clinical research in traditional Chinese medicine shows that classic compound formulas containing Poria (such as Zhenwu Decoction and Linggui Zhugan Decoction) significantly improve symptoms such as edema and shortness of breath in heart failure patients through the effect of "warming yang and promoting diuresis". A clinical RCT study (Chinese Journal of Integrated Traditional and Western Medicine 2021) showed that Zhenwu Decoction combined with conventional Western medicine treatment can increase LVEF by 3.4% and decrease NT-proBNP by 35%, which is better than the Western medicine group alone (p<0.05). Modern pharmacological research reveals that the main active components of Poria (Poria polysaccharide and triterpenoids) produce a mild diuretic effect by regulating AQP-2 aquaporin, while inhibiting the TGF-β1 / Smad3 signaling pathway to reduce myocardial fibrosis (Phytomedicine 2019), and can downregulate NF-κB to reduce the release of inflammatory factors (TNF-α, IL-6). Animal experiments have confirmed that Poria cocos extract can reduce myocardial collagen content (by 27.3%) and left ventricular end-diastolic pressure in rats with heart failure (Journal of Ethnopharmacology, 2020). Notably, a 2023 review in Frontiers in Pharmacology indicated that the combined use of Poria cocos and diuretics can reduce the risk of electrolyte disturbances.

[0034] (7) White peony root: Studies combining traditional Chinese and Western medicine have shown that white peony root has multifaceted pharmacological activities in the treatment of chronic heart failure (CHF). Clinical studies in traditional Chinese medicine have shown that classic compound prescriptions containing white peony root (such as Zhenwu Decoction and Shaoyao Gancao Decoction) can significantly improve symptoms such as palpitations and edema in heart failure patients. A study published in the Chinese Journal of Integrated Traditional and Western Medicine in 2022 showed that prescriptions containing white peony root combined with conventional Western medicine treatment can increase the left ventricular ejection fraction (LVEF) of CHF patients by 3.8% (p<0.05). Modern pharmacological studies have revealed that the main active ingredient of white peony root, paeoniflorin, inhibits myocardial hypertrophy by regulating the calmodulin-calcineurin (CaN / NFAT) signaling pathway (Phytomedicine 2023), while downregulating the TGF-β1 / Smad3 pathway to reduce myocardial fibrosis (Journal of Ethnopharmacology 2022), and can protect cardiomyocytes through antioxidant stress (increasing SOD activity) and anti-inflammatory (inhibiting NF-κB) effects. Animal experiments have shown that white peony extract can reduce the apoptosis rate of cardiomyocytes in rats with heart failure by 36.2% (Frontiers in Pharmacology 2023). A systematic review in Evidence-Based Complementary and Alternative Medicine in 2023 indicated that the overall clinical efficacy of compound treatments containing white peony in the treatment of CHF reached 81.5% (95% CI: 76.3%-86.7%).

[0035] (8) Schisandra chinensis: Studies combining traditional Chinese and Western medicine have shown that Schisandra chinensis has a multi-target regulatory effect in the treatment of chronic heart failure (CHF). Clinical studies in traditional Chinese medicine have shown that compound prescriptions containing Schisandra chinensis (such as Shengmai San and Tianwang Buxin Dan) can significantly improve symptoms of Qi and Yin deficiency such as palpitations and shortness of breath in patients with heart failure. A study in the Chinese Journal of Experimental Traditional Medical Formulae in 2022 pointed out that Shengmai San combined with conventional Western medicine treatment can increase LVEF by 3.9% and reduce BNP levels in CHF patients (p<0.05). Modern pharmacology has confirmed that the main active components of Schisandra chinensis, schisandrin A and schisandrol A, can reduce myocardial oxidative stress by activating the Nrf2 / HO-1 pathway (Oxidative Medicine and Cellular Longevity 2021), regulate SIRT1 / PGC-1α signaling to improve mitochondrial function (Journal of Ethnopharmacology 2023), and inhibit the TGF-β1 / Smad3 pathway to delay myocardial fibrosis. Animal experiments have shown that Schisandra chinensis extract can reduce the apoptosis rate of cardiomyocytes in rats with heart failure by 42.3% (Phytomedicine 2022), and its mechanism is related to the regulation of Bcl-2 / Bax protein expression. A systematic review in Frontiers in Cardiovascular Medicine in 2023 showed that the overall effective rate of Schisandra chinensis-containing compound treatment for CHF was 23.6% higher than that of the conventional treatment group (RR=1.24, 95%CI: 1.12-1.37).

[0036] (9) Licorice: Studies combining traditional Chinese and Western medicine have shown that licorice exhibits multifaceted pharmacological activities in the treatment of chronic heart failure (CHF). Clinical practice in traditional Chinese medicine has shown that classic compound formulas containing licorice (such as Zhigancao Decoction and Linggui Zhugan Decoction) can significantly improve symptoms such as palpitations and shortness of breath in patients with heart failure. A multicenter study published in the Chinese Journal of Integrated Traditional and Western Medicine in 2021 showed that Zhigancao Decoction combined with conventional treatment could increase LVEF in CHF patients by 5.1% (p<0.01) and significantly reduce the frequency of premature ventricular contractions. Modern pharmacological studies have revealed that the main active components of licorice, glycyrrhizin, glycyrrhetinic acid, and flavonoids can reduce cardiac afterload by inhibiting excessive activation of the RAAS system (Journal of Ethnopharmacology 2022), while downregulating the NF-κB inflammatory pathway to reduce the release of TNF-α and IL-6 (Phytomedicine 2023), and can improve myocardial systolic and diastolic function by regulating calmodulin and sarcoplasmic reticulum calcium pump (SERCA2a) activity. Experimental studies have confirmed that licorice extract can reduce the area of ​​myocardial fibrosis in rats with heart failure by 31.5% (Frontiers in Pharmacology, 2022), and its mechanism is related to blocking TGF-β1 / Smad3 signaling. Notably, a meta-analysis published in the Chinese Journal of Integrative Medicine in 2023 indicated that the overall effective rate of traditional Chinese medicine compound containing licorice in treating CHF was 27.3% higher than that in the control group (OR=2.15, 95%CI: 1.68-2.75).

[0037] The following detailed embodiments illustrate the traditional Chinese medicine composition of the present invention for the prevention and treatment of chronic heart failure.

[0038] Example 1

[0039] A traditional Chinese medicine composition for the prevention and treatment of chronic heart failure, comprising the following raw materials by weight:

[0040] Astragalus membranaceus 25g, red ginseng 15g, cinnamon 10g, atractylodes macrocephala 8g, ophiopogon japonicus 15g, poria cocos 15g, white peony root 15g, schisandra chinensis 10g, licorice root 8g.

[0041] Example 2

[0042] A traditional Chinese medicine composition for the prevention and treatment of chronic heart failure, comprising the following raw materials by weight:

[0043] Astragalus membranaceus 20g, red ginseng 10g, cinnamon 5g, atractylodes macrocephala 10g, ophiopogon japonicus 10g, poria cocos 20g, white peony root 10g, schisandra chinensis 5g, licorice root 5g.

[0044] Example 3

[0045] A traditional Chinese medicine composition for the prevention and treatment of chronic heart failure, comprising the following raw materials by weight:

[0046] Astragalus membranaceus 30g, red ginseng 20g, cinnamon 8g, atractylodes macrocephala 5g, ophiopogon japonicus 20g, poria cocos 10g, white peony root 20g, schisandra chinensis 7g, licorice root 10g.

[0047] Each Chinese medicine should meet the corresponding standards of the Chinese Pharmacopoeia. Each medicinal material must be cleaned before processing to ensure that it is free of impurities and mold.

[0048] Preparation of medicinal food packets: Mix the above nine medicinal herbs and pack them into a food-grade non-woven fabric medicine packet. Divide the mixture into several portions as needed, seal and store in a cool, dry place.

[0049] Example 4

[0050] A type of medicinal steamed rice, the preparation method of which is as follows:

[0051] Prepare a medicinal food packet using the herbal composition from Example 1. Take one packet (10g), soak it in 500ml of water for 30 minutes, then place the packet and soaking solution into a rice cooker along with 150g of brown rice. Cook using the standard rice cooking program. After cooking, remove the packet, divide the medicinal rice into 100g portions, and refrigerate. When ready to eat, steam the rice and consume 1-2 portions daily as a staple food substitute.

[0052] Example 5

[0053] The method for making a medicinal porridge is as follows:

[0054] Prepare a medicinal food packet using the herbal composition from Example 1. Take one packet (10g), add 500ml of water and soak for 2 hours. Then, put the soaking liquid and 50g of brown rice or white rice into a rice cooker and cook using the regular porridge cooking program until the rice is soft and tender. Remove the herbal packet before eating. It is recommended to take it once a day for 4 consecutive weeks as one course of treatment.

[0055] Example 6

[0056] The method for making a medicinal rice porridge is as follows:

[0057] Prepare a medicinal food packet using the herbal composition from Example 1. Take one packet (10g) and soak it together with 50g of japonica rice and 20g of millet for 4 hours. Pour the medicinal food ingredients, soaking liquid, and auxiliary ingredients into a high-speed blender, add water to 500ml, and select the "rice paste" program. The resulting product is approximately 400ml. Take it warm twice a day, morning and evening. It is suitable for those with weak digestive function.

[0058] Example 7

[0059] The method for making a medicinal steamed bun is as follows:

[0060] Prepare a medicinal food packet using the herbal composition from Example 1. Take one packet (10g), add 300ml of warm water and soak for 3 hours. Filter out 150ml of the liquid and mix it with 200g of all-purpose flour. Add 2g of yeast and knead into a dough. After fermentation, steam for 20 minutes. One packet (approximately 50g of flour) can be consumed per meal.

[0061] Example 8

[0062] The method for making a medicinal pastry is as follows:

[0063] Prepare a medicinal food packet using the herbal composition from Example 1. Take one packet (10g) and prepare a decoction (1:10). Use the decoction to replace water when making dough, adding buckwheat flour and yam flour (3:1 ratio) to make a sugar-free steamed cake. Each 100g of cake contains 8g of raw herbs. It is packaged individually (50g per packet) and consumed as a snack between meals, with a maximum of 2 packets per day.

[0064] Example 9

[0065] The method for making a medicinal soup is as follows:

[0066] Prepare a medicinal food packet using the herbal composition from Example 1. Take one packet (10g) and place it in a stewing pot with 100g of lean meat (or one crucian carp) and two slices of ginger. Add 800ml of water and simmer over low heat for 2 hours. Remove the herbal packet and add a little salt (daily sodium intake should be controlled within 500mg) to taste. Consume 3-4 times per week.

[0067] Example 10

[0068] The method for making a medicinal tea egg is as follows:

[0069] Prepare a medicinal food packet using the herbal composition from Example 1. Take two packets (10g each), add 800ml of water, and boil for 15 minutes. Remove the packet, add six hard-boiled, shelled eggs and 10ml of light soy sauce, and soak for 12 hours. Each egg contains approximately 3g of raw herbs, and 1-2 eggs can be consumed daily as a protein supplement.

[0070] Example 11

[0071] The preparation method of a medicinal tea is as follows:

[0072] Prepare a medicinal food packet using the herbal composition from Example 1. Place one packet (10g) in a cup, add 300ml of 90℃ hot water, cover and steep for 15 minutes before drinking. It can be steeped 2-3 times, 1-2 packets per day.

[0073] Clinical trials

[0074] I. Diagnostic criteria for chronic heart failure:

[0075] 1. Traditional Chinese Medicine Diagnostic Criteria

[0076] It was formulated based on the relevant contents of the "Expert Consensus on the Diagnosis and Treatment of Chronic Heart Failure with Traditional Chinese Medicine (2022)" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs".

[0077] Main symptoms:

[0078] (1) Palpitation and shortness of breath, which worsen with exertion;

[0079] (2) Lower limb edema, pitting edema upon pressure;

[0080] (3) Chest tightness and shortness of breath, unable to lie flat.

[0081] Secondary symptoms:

[0082] (1) Fatigue and weakness, spontaneous sweating and night sweats;

[0083] (2) Fear of cold, cold limbs, or hot flashes in the palms, soles, and chest;

[0084] (3) Abdominal distension, poor appetite, and palpable mass under the ribs;

[0085] (4) Frequent urination at night or little urination.

[0086] Tongue and pulse:

[0087] Tongue body: Pale and swollen with teeth marks (Yang deficiency) or dark purple with ecchymosis (blood stasis);

[0088] Tongue appearance: White and slippery (due to water retention) or peeling (due to yin deficiency);

[0089] Pulse characteristics: deep, thready, and weak (deficiency syndrome) or intermittent and irregular (poor heart pulse).

[0090] Differential diagnosis:

[0091] If two primary symptoms and any three secondary symptoms are present, combined with tongue and pulse diagnosis, the diagnosis can be:

[0092] (1) Heart and kidney yang deficiency syndrome (accompanied by aversion to cold, cold limbs, pale and swollen tongue);

[0093] (2) Qi and Yin deficiency syndrome (accompanied by dry mouth, night sweats, red tongue with little coating);

[0094] (3) Yang deficiency with water retention syndrome (also present with generalized edema and white, slippery tongue coating).

[0095] 2. Western Medicine Diagnostic Criteria

[0096] This document was drafted with reference to the 2022 Chinese Guidelines for the Diagnosis and Treatment of Chronic Heart Failure and the 2021 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure.

[0097] Essential conditions:

[0098] (1) Typical symptoms of heart failure (dyspnea, fatigue, edema, etc.);

[0099] (2) Objective evidence of cardiac structural / functional abnormalities (meeting any one of the following criteria):

[0100] LVEF≤40% (Heart failure with reduced ejection fraction, HFrEF);

[0101] LVEF 41-49% with elevated natriuretic peptides (mildly decreased ejection fraction, HFmrEF);

[0102] LVEF ≥ 50% with elevated natriuretic peptide / diastolic dysfunction (preservative ejection fraction, HFpEF).

[0103] Supported standards:

[0104] (1) Laboratory tests:

[0105] BNP ≥ 35 pg / ml or NT-proBNP ≥ 125 pg / ml (non-acute phase);

[0106] Myocardial injury markers (such as elevated hs-cTnT).

[0107] (2) Imaging examinations:

[0108] Echocardiography showed left ventricular hypertrophy / enlargement and E / e' ≥ 13 (diastolic dysfunction);

[0109] Lung ultrasound showed an increase in B-lines (pulmonary congestion).

[0110] (3) Functional assessment:

[0111] A 6-minute walking test showed a distance of less than 300 meters.

[0112] NYHA functional class II-IV.

[0113] II. Treatment Plan

[0114] Patients with chronic heart failure were randomly divided into a control group and a medicinal diet group, with 30 patients in each group. The control group received basic Western medicine treatment daily (diuretics, beta-blockers, ACE inhibitors, or digitalis, etc.), while the medicinal diet group received traditional Chinese medicine dietary therapy in addition to basic Western medicine treatment. The treatment period was one month.

[0115] III. Observation Indicators

[0116] 1. Comparison of cardiac function indicators between the two groups

[0117] Table 1 shows the changes in cardiac function indicators, including left ventricular ejection fraction (LVEF), left ventricular fractional shortening (LVFS), and E / A ratio, between the two groups before and after treatment. Before treatment, there was no significant difference in cardiac function indicators between the two groups (P > 0.05), indicating comparability. Both groups showed significant improvement in cardiac function indicators before and after treatment (P < 0.01). After treatment, the improvement in cardiac function indicators was more pronounced in the medicinal diet group (P < 0.05), exceeding that in the control group, demonstrating the advantage of traditional Chinese medicine medicinal diet in improving cardiac function indicators.

[0118] Table 1: Comparison of cardiac function indicators before and after treatment in the two groups ( )

[0119]

[0120] Note: t-test or rank-sum test showed that before treatment, P > 0.05; before and after treatment, P < 0.01; after treatment, P < 0.05.

[0121] 2. Comparison of neuroendocrine cytokine indices between the two groups

[0122] Plasma atrial natriuretic peptide (ANP) and endothelin (ET) were measured using radioimmunoassay before and after treatment. Plasma norepinephrine (NE) was measured using enzyme-linked immunosorbent assay (ELISA), and plasma nitric oxide (NO) was measured using the Griess method. As shown in Table 2: Before treatment, there were no significant differences in any of the indicators between the two groups (P > 0.05), indicating comparability. After treatment, all indicators in both groups decreased significantly (P < 0.01), demonstrating a significant difference between before and after treatment. This indicates that both the control group and the medicinal diet group had a reducing effect on neuroendocrine cytokine indicators, but the medicinal diet group was superior to the control group (p < 0.05).

[0123] Table 2: Comparison of various indicators of neuroendocrine cytokines between the two groups before and after treatment ( )

[0124]

[0125] Note: According to t-test or rank-sum test, the comparison between the two groups before treatment was P>0.05; the comparison between the two groups before and after treatment was P<0.01; and the comparison between the two groups after treatment was P<0.05.

[0126] Animal experiments

[0127] I. Experimental Methods

[0128] 1. Establishment of the CHF model: Rats in the experimental group were intraperitoneally injected with 1.0 mg / ml doxorubicin solution (diluted with 0.9% NaCl injection) once a week at a dose of 2 mg / kg, for a total of 6 weeks, for a total dose of 12 mg / kg body weight. The dose for each injection was calculated based on the pre-injection body weight. After 6 injection cycles, cardiac function was assessed to determine if the heart failure model had been successfully replicated.

[0129] 2. Grouping: First, 40 SD rats were randomly divided into a normal group (n=10) and the remaining 30 rats to be injected with doxorubicin to replicate the CHF model. After 6 weeks of injection, cardiac function was measured (echocardiography) to ensure successful CHF modeling. Based on the cardiac function measurement results, the 30 SD rats to replicate the CHF model were then divided into a model group, a medicinal diet group, and an enalapril group, with 10 rats in each group.

[0130] 3. Administration Method: After model establishment, rats were administered the drug via gavage at week 7, with dosage calculated using the human-mouse body surface area method. The dosage for the medicated diet group and the enalapril group was 1.44 g / kg / day and 1.8 mg / kg / day, respectively, while the normal group and the model group received an equal volume of distilled water via gavage. The administration method was once daily, 2 ml per dose, for 4 weeks.

[0131] 4. Echocardiography: The three commonly used indicators in echocardiography are: left ventricular ejection fraction (LVEF), left ventricular fractional shortening (LVFS), and E-wave to A-wave ratio (E / A). The results are taken as the average of 5 cardiac cycles.

[0132] 5. Detection of NT-proBNP and cytokines

[0133] Blood was collected from the anterior abdominal aorta of euthanized rats, anticoagulated with heparin sodium, and after standing for 30 min, the whole blood was centrifuged at 3000 rpm for 10 min. The separated serum was stored at -80℃. NT-proBNP, IL-10, and ET-1 were measured using ELISA, and TNF-α was measured using radioimmunoassay. The procedures were strictly performed according to the kit instructions.

[0134] II. Experimental Results

[0135] 1. Changes in cardiac function (LVEF, LVFS, E / A) in rats of different groups after the experiment

[0136] Compared with the normal group, the LVEF, LVFS, and E / A values ​​of each experimental group were significantly lower (P < 0.05). The LVEF, LVFS, and E / A values ​​of the medicinal diet group and the enalapril group were significantly different from those of the model group (P < 0.05). Among them, the LVEF and LVFS values ​​of the medicinal diet group were significantly higher than those of the enalapril group (P < 0.05). See Table 3.

[0137] Table 3: Comparison of cardiac function among rats in each group (n=40, )

[0138]

[0139] Note: Compared with the normal group, ▽P<0.05; compared with the model group, △P<0.05; compared with the enalapril group, ▲P<0.05.

[0140] 2. Comparison of serum NT-proBNP levels in rats from different groups

[0141] NT-proBNP levels in all experimental groups were higher than those in the normal group (P < 0.05). NT-proBNP levels in the medicinal diet group and enalapril group were lower than those in the model group, with statistically significant differences (P < 0.05). NT-proBNP levels in the medicinal diet group were also lower than those in the enalapril group, with statistically significant differences (P < 0.05). See Table 4.

[0142] Table 4: Comparison of serum NT-proBNP levels in rats of different groups (n=40, )

[0143]

[0144] Note: Compared with the normal group, ▽P<0.05; compared with the model group, △P<0.05; compared with the enalapril group, ▲P<0.05.

[0145] 3. Changes in cytokines after the experiment

[0146] The changes in TNF-α, IL-10, and ET-1 in rats after the experiment are shown in Table 5. Table 5 shows that the normal group had the lowest TNF-α level, and the difference between the normal group and the other groups was statistically significant (P < 0.05); the model group had the highest TNF-α level, and the difference between the model group and the other groups was statistically significant (P < 0.05). The enalapril group showed a statistically significant difference compared with the medicinal diet group (P < 0.05).

[0147] Among the various groups, the normal group had the lowest IL-10 level, and the difference between the normal group and the other groups was statistically significant (P < 0.05). The model group showed a statistically significant difference compared to the enalapril group and the medicinal diet group (P < 0.05). There was no statistically significant difference between the enalapril group and the medicinal diet group (P > 0.05).

[0148] Comparison of ET-1 levels among the groups showed that the normal group had the lowest ET-1 levels, with statistically significant differences compared to other groups (P < 0.05); the model group had the highest ET-1 levels, with statistically significant differences compared to other groups (P < 0.05). There was no statistically significant difference between the enalapril group and the medicinal diet group (P > 0.05).

[0149] Table 5: Changes in cytokines after drug administration (n=40, )

[0150]

[0151] Note: Compared with the normal group, ▽P<0.05; compared with the model group, △P<0.05; compared with the enalapril group, ▲P<0.05.

[0152] In summary, the traditional Chinese medicine composition of the present invention for the prevention and treatment of chronic heart failure can effectively improve cardiac function when used as a medicinal diet.

[0153] It should be noted that the medicinal cuisine in this invention is defined in a broad sense: medicinal cuisine is not limited to "food and medicine of the same origin" ingredients, but also includes medicinal materials with clear medicinal value but high safety.

[0154] In the traditional Chinese medicine composition of this invention, red ginseng, atractylodes macrocephala, white peony root, and schisandra chinensis are not medicinal materials that are both food and medicine, but each component has low toxicity and controllable side effects.

[0155] Red ginseng: Although it is a warming tonic, studies have shown that the incidence of side effects is significantly reduced when it is taken at clinical doses (3-5g / day); and its toxicity can be reduced by combining it with white peony root and schisandra fruit.

[0156] Atractylodes macrocephala: It is warm in nature and invigorates the spleen and replenishes qi. Clinical studies have shown that no obvious adverse reactions were observed when the dosage of less than 10g / day was used in medicinal diets (such as Atractylodes macrocephala and Poria cocos porridge).

[0157] White peony root: slightly cold, but its coldness can be reduced after stir-frying. Clinical studies show that a daily dose of 6-15g is safe in medicinal diets (such as white peony root and mutton porridge).

[0158] Schisandra chinensis: When the daily dose is ≤10g (such as Schisandra chinensis tea), it can have antioxidant and liver-protective effects, and clinical studies have confirmed its safety.

[0159] The embodiments of the present invention have been described in detail above, but the present invention is not limited to the described embodiments. For those skilled in the art, various changes, modifications, substitutions, and variations made to these embodiments without departing from the principles and spirit of the present invention still fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for the prevention and treatment of chronic heart failure, characterized in that, Includes the following ingredients by weight: Astragalus membranaceus 20-30 parts, red ginseng 10-20 parts, cinnamon 5-10 parts, atractylodes macrocephala 5-10 parts, ophiopogon japonicus 10-20 parts, poria cocos 10-20 parts, white peony root 10-20 parts, schisandra chinensis 5-10 parts, licorice root 5-10 parts.

2. The traditional Chinese medicine composition for preventing and treating chronic heart failure according to claim 1, characterized in that, Astragalus membranaceus 25 parts, red ginseng 15 parts, cinnamon 10 parts, atractylodes macrocephala 8 parts, ophiopogon japonicus 15 parts, poria cocos 15 parts, white peony root 15 parts, schisandra chinensis 10 parts, licorice root 8 parts.

3. The application of the traditional Chinese medicine composition as described in claim 1 in medicinal cuisine.

4. The application according to claim 3, characterized in that, The medicinal cuisine is one of the following: medicinal steamed rice, medicinal porridge, medicinal rice paste, medicinal steamed buns, medicinal pastries, medicinal soup, medicinal tea eggs, or medicinal tea drinks.

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