Yang-warming and qi-tonifying formula and application thereof in chronic heart failure

Abstract

The invention relates to a traditional Chinese medicine composition and medical application thereof, in particular to a yang-warming and qi-tonifying formula and application thereof in chronic heart failure. The traditional Chinese medicine composition is prepared from fructus rosae laevigatae, astragalus membranaceus, kadsura pepper stem, leech, ginseng, semen lepidii, angelica sinensis, schizonepeta, divaricate saposhnikovia root, cassia twig, poria cocos, bighead atractylodes rhizome and liquorice. According to the composition, monarch, minister, assistant and guide are combined, syndrome differentiation is taken as a main part, disease differentiation is taken as an auxiliary part, diseases and syndromes are combined, and deficiency and excess are combined, clinical experiments show that the prescription can obviously prolong the 6WMT distance of a CHF patient, improve the exercise tolerance of the patient, reduce the blood plasma BNP level, improve the heart failure curative effect integral, reduce the traditional Chinese medicine symptom integral and improve the life quality of the patient, and the curative effect is definite; the traditional Chinese medicine composition is suitable for further popularization and application.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition and medical use thereof, and in particular to a yang-warming and qi-invigorating prescription and application thereof in chronic heart failure. Background Art

[0002] Chronic congestive heart failure (CHF) is a syndrome of decreased heart function, mainly manifested by the heart's inability to effectively pump blood to meet the body's needs, leading to fluid retention and tissue hypoxia. Chronic congestive heart failure can be caused by a variety of heart diseases, including coronary heart disease, hypertension, cardiomyopathy, valvular disease, etc.

[0003] According to statistics, the incidence of chronic heart failure is about 1% to 2% worldwide, but this figure rises to 10% to 20% in the elderly population aged 65 and above. Studies in the United States show that about 6 million adults are diagnosed with heart failure. The incidence of heart failure increases significantly with age. The incidence rate is higher in people over 60 years old. Men usually suffer from heart failure earlier than women, but the incidence rate of women gradually increases after entering old age, and even exceeds that of men in certain age groups. Lifestyle factors such as smoking, alcoholism, poor eating habits, and lack of exercise increase the risk of heart failure.

[0004] In terms of treatment, diuretics: help remove excess fluid from the body, relieve edema and dyspnea. ACE inhibitors: improve heart function, reduce heart failure symptoms, and have a kidney-protective effect. β-adrenergic antagonists: improve heart function, reduce heart rate, and increase cardiac output. Aldosterone antagonists: reduce cardiac remodeling and improve prognosis. Digoxin can be used to increase cardiac contractility in certain circumstances.

[0005] It can be seen that chronic congestive heart failure is one of the common diseases in the elderly and has been a hot topic in clinical research for many years. It seriously affects the quality of life of patients and even endangers their lives. This disease belongs to the category of "heart failure", "palpitations", "palpitations" and "asthma" in traditional Chinese medicine. The disease is widespread and involves multiple organs. The pathogenesis of traditional Chinese medicine is mainly deficiency of the root and excess of the symptoms, among which deficiency of heart qi, blood stasis and water retention are the most common. Therefore, warming yang and invigorating qi, promoting blood circulation and promoting diuresis are the key to treating this disease. Summary of the invention

[0006] One of the purposes of the present invention is to provide a Chinese medicine composition and its use in preparing drugs for treating coronary heart disease; the warming yang and invigorating qi of the present invention has a significant therapeutic effect in chronic heart failure, especially in the treatment of chronic congestive heart failure, through clinical experiments.

[0007] Specifically, the technical solution of the present invention is achieved as follows:

[0008] The first object of the present invention is to provide a Chinese medicine composition for treating chronic heart failure, wherein the Chinese medicine composition is made of the following Chinese medicines:

[0009] 40-60 weight parts of Rosa laevigata, 20-40 weight parts of Astragalus, 2-8 weight parts of Caulis Piperis, 2-8 weight parts of Leech, 5-15 weight parts of Ginseng, 5-15 weight parts of Lepidium, 8-20 weight parts of Angelica, 5-16 weight parts of Schizonepeta, 5-16 weight parts of Saposhnikovia, 4-15 weight parts of Cassia twig, 10-25 weight parts of Poria, 8-20 weight parts of Atractylodes, and 3-10 weight parts of Licorice.

[0010] Further, in order to provide the therapeutic effect of the present invention, the scutellaria baicalensis seeds described in the present invention are stir-fried scutellaria baicalensis seeds, and the atractylodes macrocephala is stir-fried atractylodes macrocephala with bran.

[0011] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following Chinese medicines:

[0012] 60 parts by weight of Rosa rugosa, 40 parts by weight of Astragalus, 8 parts by weight of Caulis Piperis, 8 parts by weight of Hirudo, 15 parts by weight of Ginseng, 15 parts by weight of Stir-fried Leonurus japonicus, 20 parts by weight of Angelica sinensis, 16 parts by weight of Schizonepeta tenuifolia, 16 parts by weight of Saposhnikovia divaricata, 15 parts by weight of Cinnamon twig, 25 parts by weight of Poria, 20 parts by weight of Stir-fried Atractylodes macrocephala with bran, and 10 parts by weight of Licorice.

[0013] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following Chinese medicines:

[0014] 40 parts by weight of Rosa rugosa, 20 parts by weight of Astragalus, 2 parts by weight of Caulis Piperis, 2 parts by weight of Hirudo, 5 parts by weight of Ginseng, 5 parts by weight of Stir-fried Leonurus, 8 parts by weight of Angelica sinensis, 5 parts by weight of Schizonepeta tenuifolia, 5 parts by weight of Saposhnikovia divaricata, 4 parts by weight of Cinnamon twig, 10 parts by weight of Poria, 8 parts by weight of Stir-fried Atractylodes macrocephala with bran, and 3 parts by weight of Licorice.

[0015] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following Chinese medicines:

[0016] 50 parts by weight of Rosa rugosa, 30 parts by weight of Astragalus, 5 parts by weight of Caulis Piperis, 5 parts by weight of Hirudo, 9 parts by weight of Ginseng, 9 parts by weight of Stir-fried Leonurus japonicus, 12 parts by weight of Angelica sinensis, 10 parts by weight of Schizonepeta tenuifolia, 10 parts by weight of Saposhnikovia divaricata, 9 parts by weight of Cinnamon twig, 15 parts by weight of Poria, 12 parts by weight of Stir-fried Atractylodes macrocephala with bran, and 6 parts by weight of Licorice.

[0017] The second object of the present invention is to use the Chinese medicine composition in preparing a drug for treating chronic heart failure. Furthermore, the chronic heart failure is a syndrome of deficiency of heart qi, blood stasis and water retention.

[0018] The third object of the present invention is that the oral Chinese medicine preparation is any one of a decoction, a tablet, a capsule, and a granule.

[0019] A fourth object of the present invention is to provide a method for preparing a decoction, wherein the method comprises the following steps:

[0020] 1) Add 10-20 times the amount of water to stir-fried radix scutellariae, ginseng, angelica, tuckahoe, rosa laevigata, astragalus, stir-fried atractylodes macrocephala and licorice, decoct for 30-40 minutes, filter, and set aside the filtrate and residue; add 4-8 times the amount of water to the residue, decoct for 15-25 minutes, filter, and combine the two filtrates; set aside;

[0021] 2) Crush Nepeta, Saposhnikovia, Cinnamomum cassia, Caulis Piperis and Leech, add 75% ethanol and reflux extract twice, combine the filtrate and set aside;

[0022] 3) The filtrates from steps 2) and 3) are combined and concentrated at 60-70° C. to a relative density of 1.08-1.13 to obtain a decoction.

[0023] A fifth object of the present invention is to provide a method for preparing granules, wherein the method comprises the following steps:

[0024] 1) Crush the leeches through a 16-mesh sieve, and prepare the leech powder for later use;

[0025] 2) Add 10-20 times the amount of water to the stir-fried radix scutellariae, ginseng, angelica, tuckahoe, rosa laevigata, astragalus, bran-fried atractylodes and licorice, boil for 30-40 minutes, filter, and set aside the filtrate and residue; add 4-8 times the amount of water to the residue, boil for 15-25 minutes, filter, and combine the two filtrates; set aside

[0026] 3) Crush Nepeta, Saposhnikovia, Cinnamomum cassia, Caulis Piperis and Leech, add 75% ethanol and reflux extract twice, combine the filtrate and set aside;

[0027] 4) combining the filtrates from step 2) and step 3), concentrating at 60-70° C. to a relative density of 1.05-1.11, standing for 6-12 hours, taking the supernatant, adding leech powder, concentrating at 65-75° C. to a relative density of 1.25-1.35, and obtaining a concentrated solution for standby use;

[0028] 5) Add 3 times the total weight of the concentrate into a mixture of dextrin and sucrose, granulate, and dry to obtain the product.

[0029] The basic pathogenesis of CHF is qi (yang) deficiency, blood stasis and water retention, which belongs to the syndrome of deficiency in the root and excess in the superficial. The deficiency of heart qi and heart yang is the root, and blood stasis, water retention and phlegm are the superficial. The pathological characteristics are deficiency in the root and excess in the superficial, and the mixture of deficiency and excess. Qi deficiency in heart yang is the pathological basis, blood stasis is the central pathological link, and water retention and phlegm are the main pathological products. In the prescription of warming yang and replenishing qi, astragalus and golden cherry are used as monarch drugs, which are the main drugs for replenishing heart qi. Astragalus has the effect of promoting blood circulation and promoting diuresis, and golden cherry has the effect of anti-inflammatory and detoxification. Piper mesenteriae, scutellariae, leech and ginseng are used as minister drugs. Among them, ginseng, which is a product of great replenishment of vital energy, can restore the pulse and consolidate the body, replenish the spleen and benefit the lungs, and strengthen the function of replenishing qi. The monarch and minister match, replenish the heart qi, and complement each other. Scutellariae, a bitter product, can drain the lungs and expel water, relieve cough and asthma, and can promote water to flow to the bladder, remove phlegm and benefit the lung qi. The lung is in charge of all meridians, and is responsible for spreading and descending. It is the upper source of water. When the lung qi is regulated, it will give water evil a way out. Sea wind vine and leech spleen are responsible for transportation and transformation. Strengthening the spleen helps the normal metabolism of water, avoids water retention, and can also replenish qi, improve heart qi, drive systemic fluid circulation, help improve heart blood supply, and may help improve heart function. It is supplemented with angelica, schizonepeta, saposhnikovia, cinnamon twig, Poria and Atractylodes as adjuvants. Among them, angelica enters the heart and liver meridians to replenish blood and activate blood circulation; cinnamon twig is sweet and warm and can transport spleen and eliminate dampness, and enters the bladder meridian to warm yang and transform qi, so as to eliminate water, dampness, phlegm and fluid evil; Poria and stir-fried Atractylodes strengthen spleen, promote water and eliminate dampness; schizonepeta enters lung meridian and liver meridian and has anti-inflammatory and anti-allergic effects; saposhnikovia enters bladder meridian, liver meridian and spleen meridian to enhance the function of spleen and stomach. The six medicines are compatible, blood stasis is transformed, water is circulated, and heart meridian is unblocked. Licorice, an adjuvant herb, harmonizes the other medicines and together they play the role of warming the yang, invigorating qi, promoting blood circulation and promoting diuresis.

[0030] Compared with the prior art, the composition of the present invention has achieved unexpected technical effects:

[0031] 1) The prescription of the present invention has clinical promotion value in treating heart failure of deficiency of heart qi. The composition of the present invention can improve the patient's exercise tolerance, reduce the plasma BNP level, and achieve the purpose of relieving shortness of breath, improving heart failure symptoms such as palpitations and chest tightness. The prescription of the present invention has all the monarch, minister, assistant and envoy. The prescription is mainly based on syndrome differentiation, supplemented by disease differentiation, combining disease and syndrome, and taking into account the combination of deficiency and excess, which is the characteristic of the present invention in treating heart failure.

[0032] 2) The results of clinical studies have shown that the prescription can significantly prolong the 6WMT distance of CHF patients, improve patients' exercise tolerance, reduce plasma BNP levels, improve heart failure efficacy scores, reduce traditional Chinese medicine symptom scores, and improve patients' quality of life. It has a definite therapeutic effect and no obvious toxic side effects.

[0033] 3) Pharmacological experiments have shown that the prescription of the present invention can reduce the oxidative stress response of rats with myocardial ischemia-reperfusion, and can also enhance the antioxidant capacity of myocardial cells, and has a good protective effect on myocardial cells. The granules prepared have been confirmed by pharmacological experiments to have higher efficacy, and are easy to carry, easy to take, clean and hygienic. They are clinically used to treat heart failure of the deficiency of heart qi, and have reliable efficacy. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 : Comparison of LVEF (%) of each group. The positive group, Example 1-3 groups and Comparative Example 1-5 groups all had therapeutic effects, but the therapeutic effects of Example 1-3 were better than those of other examples, especially Example 1 had the best effect.

[0035] Figure 2 : Comparison of LVFS (%) of each group. The positive group, Example 1-3 groups and Comparative Example 1-5 groups all had therapeutic effects, but the therapeutic effects of Examples 1-3 were better than those of other examples, especially Example 1 had the best effect, which was significantly different from the positive group (P<0.05).

[0036] Figure 3 : The comparison results of TNF-α in each group showed that compared with the model group, the inflammatory factors of rats in each drug-treated group were reduced to varying degrees (P < 0.05 or P < 0.01). There were significant differences between the positive group and Example 1-3 groups and the comparative example 1-5 groups (P < 0.01).

[0037] Figure 4 : The comparison results of IL-6 in each group showed that compared with the model group, the inflammatory factors of rats in each drug-treated group were reduced to varying degrees (P < 0.05 or P < 0.01). There were significant differences between the positive group and Example 1-3 groups and the comparative example 1-5 groups (P < 0.01).

[0038] Figure 5 : The comparison results of hs-CRP in each group showed that compared with the model group, the inflammatory factors of rats in each drug-treated group were reduced to varying degrees (P < 0.05 or P < 0.01), and there were significant differences between the positive group and Example 1-3 groups and the comparative example 1-5 groups (P < 0.01).

[0039] Figure 6 : The comparison results of MCP-1 in each group show that, compared with the model group, the inflammatory factors in the rats in each drug-treated group were reduced to varying degrees (P < 0.05 or P < 0.01), and there were significant differences between the positive group and the Example 1-3 groups and the Comparative Example 1-5 groups (P < 0.01). Specific embodiments

[0040] The present invention is further explained below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not used to limit the scope of the present invention. After reading the present invention, various equivalent modifications of the present invention by those skilled in the art all fall within the scope defined by the claims attached to this application.

[0041] Example 1: A drug for treating chronic heart failure, the dosage and preparation process are as follows:

[0042] 50g of Rosa rugosa, 30g of Astragalus, 5g of Piper membranaceus, 5g of Leech, 9g of Ginseng, 9g of Stir-fried Lepidium japonicum, 12g of Angelica sinensis, 10g of Schizonepeta tenuifolia, 10g of Saposhnikovia divaricata, 9g of Cassia twig, 15g of Poria, 12g of Stir-fried Atractylodes macrocephala with bran, and 6g of Licorice.

[0043] Preparation process:

[0044] 1) Crush the leeches through a 16-mesh sieve, and prepare the leech powder for later use;

[0045] 2) Add 10-20 times the amount of water to the stir-fried radix scutellariae, ginseng, angelica, tuckahoe, rosa laevigata, astragalus, bran-fried atractylodes and licorice, boil for 30-40 minutes, filter, and set aside the filtrate and residue; add 4-8 times the amount of water to the residue, boil for 15-25 minutes, filter, and combine the two filtrates; set aside

[0046] 3) Crush Nepeta, Saposhnikovia, Cinnamomum cassia, Caulis Piperis and Leech, add 75% ethanol and reflux extract twice, combine the filtrate and set aside;

[0047] 4) combining the filtrates from step 2) and step 3), concentrating at 60-70° C. to a relative density of 1.05-1.11, standing for 6-12 hours, taking the supernatant, adding leech powder, concentrating at 65-75° C. to a relative density of 1.25-1.35, and obtaining a concentrated solution for standby use;

[0048] 5) Add a mixture of dextrin and sucrose (the weight ratio of sucrose: dextrin is 8:1) in an amount of 3 times the total weight of the concentrate in step 3), granulate, and dry to obtain 100 g, 10 g per bag.

[0049] Example 2: A drug for treating chronic heart failure, the dosage and preparation process are as follows:

[0050] 40g of Rosa rugosa, 20g of Astragalus, 2g of Piper membranaceus, 2g of Leech, 5g of Ginseng, 5g of stir-fried Lepidium membranaceus, 8g of Angelica sinensis, 5g of Schizonepeta tenuifolia, 5g of Saposhnikovia divaricata, 4g of Cassia twig, 10g of Poria, 8g of stir-fried Atractylodes macrocephala with bran, and 3g of Licorice.

[0051] The preparation process is the same as that of Example 1.

[0052] Example 3: A drug for treating chronic heart failure, the dosage and preparation process are as follows:

[0053] 60g of golden cherry, 40g of astragalus, 8g of sea wind vine, 8g of leech, 15g of ginseng, 15g of stir-fried scutellaria, 20g of angelica, 16g of schizonepeta, 16g of siler, 15g of cassia twig, 25g of poria, 20g of stir-fried white atractylodes with bran, 10g of liquorice

[0054] The preparation process is the same as that of Example 1.

[0055] Example 4: A drug for treating chronic heart failure, the dosage and preparation process are as follows:

[0056] 60g of golden cherry, 40g of astragalus, 8g of sea wind vine, 8g of leech, 15g of ginseng, 15g of stir-fried scutellaria, 20g of angelica, 16g of schizonepeta, 16g of siler, 15g of cassia twig, 25g of poria, 20g of stir-fried white atractylodes with bran, 10g of liquorice

[0057] The pellets are prepared by conventional process.

[0058] Example 5: A drug for treating chronic heart failure, the dosage and preparation process are as follows:

[0059] 60g of golden cherry, 40g of astragalus, 8g of sea wind vine, 8g of leech, 15g of ginseng, 15g of stir-fried scutellaria, 20g of angelica, 16g of schizonepeta, 16g of siler, 15g of cassia twig, 25g of poria, 20g of stir-fried white atractylodes with bran, 10g of liquorice

[0060] The tablets are prepared by conventional process.

[0061] Example 6: A drug for treating chronic heart failure, the dosage and preparation process are as follows:

[0062] 60g of golden cherry, 40g of astragalus, 8g of sea wind vine, 8g of leech, 15g of ginseng, 15g of stir-fried scutellaria, 20g of angelica, 16g of schizonepeta, 16g of siler, 15g of cassia twig, 25g of poria, 20g of stir-fried white atractylodes with bran, 10g of liquorice

[0063] The capsules are prepared by conventional process.

[0064] Example 7: A drug for treating chronic heart failure, the dosage and preparation process are as follows:

[0065] 60g of golden cherry, 40g of astragalus, 8g of sea wind vine, 8g of leech, 15g of ginseng, 15g of stir-fried scutellaria, 20g of angelica, 16g of schizonepeta, 16g of siler, 15g of cassia twig, 25g of poria, 20g of stir-fried white atractylodes with bran, 10g of liquorice

[0066] Preparation process:

[0067] 1) Add 10-20 times the amount of water to the stir-fried radix scutellariae, ginseng, angelica, tuckahoe, rosa laevigata, astragalus, bran-fried atractylodes and licorice, boil for 30-40 minutes, filter, and set aside the filtrate and residue; add 4-8 times the amount of water to the residue, boil for 15-25 minutes, filter, and combine the two filtrates; set aside

[0068] 2) Crush Stephania tetrandra, Radix Saposhnikoviae, Rhizoma Cinnamomi, Rhizoma Piperati and Hirudo, add 75% ethanol and reflux extract twice, combine the filtrates and set aside;

[0069] 3) The filtrates from steps 2) and 3) are combined and concentrated at 60-70° C. to a relative density of 1.08-1.13 to obtain a decoction.

[0070] Comparative Example 1: A drug for treating chronic heart failure, the dosage and preparation process thereof are as follows:

[0071] Astragalus 30g, ginseng 9g, stir-fried scutellaria baicalensis seeds 9g, angelica 12g, cinnamon twig 9g, poria 15g, stir-fried white atractylodes 12g, and licorice 6g.

[0072] The preparation process is the same as that of Example 1.

[0073] Comparative Example 2: A drug for treating chronic heart failure, the dosage and preparation process thereof are as follows:

[0074] 50g of Rosa rugosa, 30g of Astragalus, 9g of Ginseng, 9g of Stir-fried Leonurus japonicus, 12g of Angelica sinensis, 9g of Cassia twig, 15g of Poria, 12g of Stir-fried Atractylodes macrocephala with bran, and 6g of Licorice.

[0075] The preparation process is the same as that of Example 1.

[0076] Comparative Example 3: A drug for treating chronic heart failure, the dosage and preparation process thereof are as follows:

[0077] Astragalus 30g, Piper mesenteriae 5g, Leech 5g, Ginseng 9g, Fried Lepidium japonicum 9g, Angelica sinensis 12g, Schizonepeta tenuifolia 10g, Saposhnikovia divaricata 10g, Cassia twig 9g, Poria 15g, Fried Atractylodes macrocephala 12g, Licorice root 6g.

[0078] The preparation process is the same as that of Example 1.

[0079] Comparative Example 4: A drug for treating chronic heart failure, the dosage and preparation process thereof are as follows:

[0080] Salvia miltiorrhiza 50g, Astragalus 30g, Piper mesenteriae 5g, Leech 5g, Ginseng 9g, Stir-fried Lepidium japonicum 9g, Angelica 12g, Schizonepeta tenuifolia 10g, Saposhnikovia divaricata 10g, Cinnamon twig 9g, Poria 15g, Stir-fried Atractylodes macrocephala 12g, Licorice root 6g.

[0081] The preparation process is the same as that of Example 1.

[0082] Comparative Example 5: A drug for treating chronic heart failure, the dosage and preparation process thereof are as follows:

[0083] 20g of Rosa rugosa, 60g of Astragalus, 12g of Caulis Piperis, 4g of Leech, 3g of Ginseng, 3g of Stir-fried Leonurus japonicus, 5g of Angelica sinensis, 6g of Schizonepeta tenuifolia, 6g of Saposhnikovia divaricata, 25g of Cassia twig, 30g of Poria, 5g of Stir-fried Atractylodes macrocephala with bran, and 3g of Licorice.

[0084] The preparation process is the same as that of Example 1.

[0085] 3. Pharmacodynamics Experiment

[0086] The following experimental studies were all conducted on the basis of the acute toxicity test and the long-term toxicity test to prove the safety of the drug, and the dosage in the experimental study was within the safe dosage range. In order to verify the use and mechanism of the Chinese medicine composition of the present invention in the treatment of coronary heart disease, the inventor conducted relevant pharmacodynamics experiments. It should be noted that the drugs selected for the following pharmacodynamics tests are drugs obtained by the representative formula of the present invention and its preparation method; the inventors also conducted pharmacodynamics experiments on drugs obtained by other formulas and preparation methods included in the present invention, and the experimental results showed that the drugs obtained by other formulas and preparation methods have the same or similar effects, but due to space limitations, they are not listed here one by one.

[0087] Verification Example 1: Therapeutic effect of the Chinese medicine composition of the present invention on a rat model of chronic heart failure

[0088] 1 Materials

[0089] 1.1 Animals:

[0090] SD rats, SPF grade, 180±20g, experimental animal license number: SYXK(Lu)2023 0031, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, were adaptively fed for one week before the experiment. This experiment strictly followed the 3R principle.

[0091] 1.2 Drugs and reagents

[0092] 1.2.1 Drugs

[0093] Granules prepared in Examples 1-3 of the present invention and Comparative Examples 1-5; Captopril (Captopril approval number: National Medicine Standard H44025140, manufacturer: Guangzhou Baiyunshan Pharmaceutical Co., Ltd., drug standard code: 86900381000715).

[0094] 1.2.3 Dosage

[0095] The granules prepared in Examples 1-3 and Comparative Examples 1-5 of the present invention were calculated based on the crude drug amount, 3.28 g / kg, and administered intragastrically once a day at 8:00 a.m.

[0096] Positive group: Captopril dosage was 2.25 mg / kg, intragastrically once a day at 8:00 am.

[0097] 2. Modeling, grouping and drug administration

[0098] Modeling: The chronic heart failure rat model was established by intraperitoneal injection of doxorubicin: the injection dose of doxorubicin was 1 mg / kg on days 1, 3, 9, 11, 13 and 15, and 2 mg / kg on days 5 and 7, with an injection volume of 1 mL. Twelve rats injected with an equal volume of saline were used as the control group. One week after the last injection, ultrasound was used to measure cardiac function indicators: left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS). The success of the model was judged based on the general behavioral signs of the rats (weight loss, mental depression, etc.) and cardiac function indicators (LVEF < 60%).

[0099] 80 rats were taken after successful modeling and randomly divided into positive control group, model group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group, 8 rats in each group. 80 rats were taken, and except for the model group (administered with the same volume of normal saline), the other groups of rats were gavaged with corresponding drugs for 28 consecutive days.

[0100] 3. Observation indicators

[0101] 3.1 Echocardiography to detect cardiac function indices: After administration, the rats were anesthetized and fixed in a supine position on the operating table. The probe of the color Doppler ultrasound diagnostic instrument was placed in front of the left chest. The long axis of the left ventricle was displayed using two-dimensional echocardiography to obtain LVEF (%) and LVFS (%).

[0102] 3.2ELISA method to detect serum inflammatory factor levels: After the ultrasound examination, 5 mL of blood was collected from the abdominal aorta, and the serum was separated by centrifugation. The optical density value was obtained according to the instructions of the ELISA kit. The serum TNF-α, IL-6, hs-CRP, and MCP-1 levels were calculated according to the standard curve.

[0103] 3.4 Statistical analysis

[0104] GraphPad Prism 6 statistical software was used for data processing. The quantitative data were expressed as mean ± standard deviation (X ± S). The paired t test was used to compare the differences between groups. The Kruskal-Wallis rank sum test was used for intra-group comparisons between multiple groups. If the data did not conform to the normal distribution, the one-way analysis of variance was used if the data conformed to the normal distribution and the variance was homogeneous. The Wilcoxon rank sum test was used to compare the distribution of paired and single samples. The linear discriminant analysis (LDA) was used to distinguish and classify the main body of the samples. The non-parametric multivariate analysis of variance (PERMANOVA) was used to compare the differences in community composition and structure. The count data were analyzed by X 2 The difference was statistically significant when p < 0.05.

[0105] 4. Results and Conclusions

[0106] 4.1 Comparison of LVEF (%) and LVFS (%) among the groups

[0107] LVEF and LVFS are important indicators for evaluating heart failure. When heart failure occurs, LVEF and LVFS decrease. Figure 1 As shown, the positive control drug increased the LVEF and LVFS at 18d and 28d after administration, with the most significant increase at 18d, while the LVEF of Examples 1-3 and Comparative Examples 1-5 increased continuously at 18d and 28d. The LVEF of Example 1-3 at 18d and 28d was significantly different from that of Comparative Examples 1-5 (P<0.01), indicating that the drug combination of the present invention is superior to the prior art and Western medicine combination. Figure 2 The positive control drug in the embodiment 1-3 and the comparative example 1-5 increased the LVFS at 18d and 28d after administration, with the most significant increase at 18d, and LVFS, while the LVFS of the embodiment 1-3 and the comparative example 1-5 increased continuously at 18d and 28d. Figure 1 and Figure 2 This indicates that the therapeutic effect of traditional Chinese medicine is relatively long-lasting, especially the traditional Chinese medicine composition of Examples 1-3, while Western medicine has a certain drug resistance, so LVEF gradually decreases at 28 days.

[0108] Figure 1 : Comparison of LVEF in each group. It can be seen that the blank group has a significant difference compared with the model group (P < 0.000), indicating that the experimental model is successfully established, and the positive group, the embodiment 1-3 group and the comparative example 1-5 group all have therapeutic effects, but the therapeutic effect of the embodiment 1-3 is better than that of the other embodiments, especially the best effect of the embodiment 1.

[0109] Figure 2: Comparison of LVFS of each group. It can be seen that the blank group has a significant difference compared with the model group (P < 0.000), indicating that the experimental model was successfully established, and the positive group, the Example 1-3 group and the Comparative Example 1-5 group all have therapeutic effects, but the therapeutic effect of the Example 1-3 is better than that of the other examples, especially the Example 1 has the best effect, which is significantly different from the positive group (P < 0.05).

[0110] 4.2 Changes of inflammatory factors in rats

[0111] Compared with the blank group, the TNF-α, IL-6, hs-CRP, and MCP-1 of the rats in the other groups were significantly increased, indicating that the modeling rats had obvious inflammatory reactions. Compared with the model group, the inflammatory factors of the rats in each drug administration group were reduced to varying degrees (P < 0.05 or P < 0.01), and the positive control group and the Example 1-3 groups were significantly different from the Comparative Examples 1-5 (P < 0.05 or P < 0.01). Figure 3-6 shown.

[0112] Figure 3 : The comparison results of TNF-α in each group show that, compared with the model group, the inflammatory factors in the rats in each administration group were reduced to varying degrees (P < 0.05 or P < 0.01), and there were significant differences between the positive group and the Example 1-3 groups and the Comparative Example 1-5 groups (P < 0.01).

[0113] Figure 4 : The comparison results of IL-6 in each group show that, compared with the model group, the inflammatory factors in the rats in each medication group were reduced to varying degrees (P < 0.05 or P < 0.01), and there were significant differences between the positive group and Example 1-3 groups and the comparative example 1-5 groups (P < 0.01).

[0114] Figure 5 : The comparison results of hs-CRP in each group show that, compared with the model group, the inflammatory factors in the rats in each drug-treated group were reduced to varying degrees (P < 0.05 or P < 0.01), and there were significant differences between the positive group and Example 1-3 groups and the comparative example 1-5 groups (P < 0.01).

[0115] Figure 6 : The comparison results of MCP-1 in each group show that, compared with the model group, the inflammatory factors in the rats in each drug-treated group were reduced to varying degrees (P < 0.05 or P < 0.01), and there were significant differences between the positive group and the Example 1-3 groups and the Comparative Example 1-5 groups (P < 0.01).

[0116] Verification Example 3: Clinical experiment verifies the use of the prescription of Example 1 of the present invention in chronic heart failure

[0117] 1. Research subjects and sources

[0118] All cases were outpatients of the Department of Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine from May 2018 to January 2023.

[0119] 2. Case selection criteria

[0120] 1. Western medicine diagnostic criteria

[0121] 2.1. Diagnostic criteria for heart failure

[0122] Refer to the "Guidelines for the Diagnosis and Treatment of Heart Failure in China" issued by the Chinese Medical Association in 2018 [1] The diagnostic criteria for heart failure are shown in Table 1.

[0123] Table 1 Classification and diagnostic criteria of heart failure

[0124]

[0125] Note: HFrEF is heart failure with reduced ejection fraction, HFmrEF is heart failure with mid-range ejection fraction, HFpEF is heart failure with preserved ejection fraction, and LVEF is left ventricular ejection fraction; elevated natriuretic peptides are B-type natriuretic peptide (BNP) > 35 ng / L and / or N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 125 ng / L; indicators of abnormal diastolic function are shown in the transthoracic echocardiography section of the diagnosis and evaluation of heart failure

[0126] 2.2. Standards for cardiac function classification

[0127] (1) It is formulated with reference to the cardiac function classification system of the New York Heart Association (NYHA).

[0128] Heart function class I: The patient has heart disease, but the amount of daily activities is not restricted, and general activities do not cause fatigue, palpitations, dyspnea or angina.

[0129] Heart function class II: The physical activity of heart disease patients is slightly restricted. They have no symptoms when resting, but may experience fatigue, palpitations, dyspnea or angina during normal activities.

[0130] Heart function class III: The physical activity of patients with heart disease is significantly limited, and the above symptoms are caused by less than normal activities.

[0131] Heart function class IV: patients with heart disease cannot engage in any physical activity. Symptoms of heart failure occur even at rest, and worsen after physical activity.

[0132] (II) TCM syndrome diagnostic criteria

[0133] With reference to the 2014 edition of “Expert Consensus on TCM Diagnosis and Treatment of Chronic Heart Failure”, TCM symptom diagnostic criteria for chronic heart failure with deficiency of heart qi and blood stasis and water retention were developed.

[0134] 1. Main symptoms: shortness of breath, wheezing, fatigue, and palpitations.

[0135] Secondary symptoms: ① Fear of cold and / or preference for warmth. ② Coldness in the stomach / abdomen / waist / limbs. ③ Cold sweat. ④ Dark purple complexion / lips.

[0136] Tongue and pulse: The tongue is dark purple (or has ecchymoses, petechiae, or tortuous purple veins under the tongue), the tongue is enlarged, or has teeth marks, and the pulse is thin, deep, slow and weak.

[0137] The diagnosis can be made by combining 2 main symptoms and 2 secondary symptoms with tongue and pulse.

[0138] 2. Associated symptoms: Phlegm and fluid syndrome: cough / sputum, chest fullness / abdominal distension, facial / limb swelling, and difficulty urinating.

[0139] Tongue and pulse: The tongue coating is smooth or greasy, or there is a slippery pulse.

[0140] If one of the concurrent symptoms is present, the diagnosis can be made based on the tongue and pulse.

[0141] Anyone who has 2 main symptoms, 2 secondary symptoms and 1 concurrent symptom, combined with tongue and pulse, can be diagnosed with chronic heart failure, heart failure with deficiency of heart qi, blood stasis and water retention.

[0142] (III) Inclusion criteria

[0143] (1) Meet the Western medical diagnostic criteria for chronic heart failure;

[0144] (2) Meet the diagnostic criteria of heart qi deficiency and blood stasis and water retention syndrome of heart failure in traditional Chinese medicine;

[0145] (3) Heart function class II to III (NYHA classification);

[0146] (4) The condition is relatively stable;

[0147] (5) Aged between 18 and 75 years old;

[0148] (6) The underlying diseases include coronary heart disease, hypertension, primary dilated cardiomyopathy, and cor pulmonale;

[0149] (7) The patients and their families agreed to participate in this trial and signed the informed consent form.

[0150] (IV) Exclusion criteria

[0151] (1) Heart function grade IV or combined with other severe cardiovascular diseases.

[0152] (2) Patients with serious primary diseases such as brain, liver, kidney, hyperthyroidism and hematopoietic system;

[0153] (3) Pregnant or lactating women;

[0154] (4) Those with allergic constitution or allergic to known ingredients of this drug

[0155] (5) Those with mental disorders and unwilling to cooperate;

[0156] (6) Those who refuse to sign the informed consent form;

[0157] (7) Factors that may increase mortality: such as cardiogenic shock, severe arrhythmia, complete atrioventricular block, obstructive cardiomyopathy, unrepaired valvular disease, constrictive pericarditis, cardiac tamponade, pulmonary embolism, obvious infection, and uncontrolled hypertension.

[0158] (V) Criteria for elimination, falling off and suspension of observation

[0159] (1) Patients who do not meet the inclusion criteria, are mistakenly admitted or misdiagnosed; patients who cannot persist in the trial and withdraw from the trial or violate the study protocol and have poor compliance should be excluded;

[0160] (2) Those who withdraw from the experiment at any time or for any reason, fail to complete the clinical trial observation, or are lost to follow-up or die are considered dropouts;

[0161] (3) If serious adverse events, serious complications, or rapid deterioration of the condition occur during the trial, the trial should be terminated immediately.

[0162] 3. Research Methods

[0163] (I) Experimental drugs and reagents

[0164] The prescription of Example 1: 50g of Rosa rugosa, 30g of Astragalus, 5g of Caulis Piperis, 5g of Hirudo, 9g of Ginseng, 9g of Stir-fried Lepidium japonicum, 12g of Angelica sinensis, 10g of Schizonepeta tenuifolia, 10g of Saposhnikovia divaricata, 9g of Cinnamon twig, 15g of Poria, 12g of Stir-fried Atractylodes macrocephala, and 6g of Licorice. The above Chinese medicines are prepared into a decoction according to Example 7.

[0165] Digoxin approval number: National Medicine Standard H33021738, manufacturer: Sanofi (Hangzhou) Pharmaceutical Co., Ltd., drug standard code: 86904502000127; Spironolactone approval number: National Medicine Standard H44023416, manufacturer: Guangzhou Kanghe Pharmaceutical Co., Ltd., drug standard code 86900401000756; Furosemide approval number: National Medicine Standard H62020258, manufacturer: Gansu Chengji Bio-Pharmaceutical Co., Ltd., drug standard code: 86905889000427.

[0166] (II) Method of administration

[0167] Control group: Routine treatment of primary disease, oxygen inhalation, diuretics, beta-blockers and myocardial nutrition and other conventional western medicine treatments were given. For patients with obvious symptoms of heart failure, digoxin 0.125 mg, qd, spironolactone 20 mg, qd, and furosemide 20 mg, qd were added.

[0168] Observation group: Wenyang Yiqi prescription (prescription of Example 7), decocted in water, one dose per day, taken warm twice a day in the morning and evening, 4 weeks as a course of treatment, other Chinese medicine preparations were discontinued during the treatment.

[0169] (III) Observation indicators and measurement methods

[0170] 1. Safety observation indicators

[0171] (1) General physical examination items: blood pressure, heart rate, pulse, electrocardiogram and other general conditions;

[0172] (2) routine blood and urine tests, liver and kidney function (ALT, AST, BUN, Cr);

[0173] (3) Possible adverse reactions: record the time of occurrence, clinical manifestations, abnormal indicators, severity, and disappearance method.

[0174] 2.6-minute walk test (6WMT).

[0175] The patient walks back and forth along the designated area of ​​the corridor of the department within 6 minutes. There are physical signs at the turning point, and a mark is made every 3 meters. Before the test, the patient is informed of the test process and the surrounding environment. The patient adjusts the pace and rests according to his own situation in the middle. He can continue walking after recovery. During the test, the recorder at one end of the corridor records the patient's walking distance and the discomfort symptoms during exercise, such as chest tightness, shortness of breath, fatigue, sweating, dizziness, etc. Appropriate encouragement can be given during the test.

[0176] (1) 6WMT distance less than 150m indicates severe heart failure.

[0177] (2) 6WMT distance is 150-425m, indicating moderate heart failure.

[0178] (3) 6WMT distance 425-550m, indicating mild heart failure.

[0179] 3. Plasma brain natriuretic peptide (BNP) level

[0180] The plasma BNP level of patients with heart failure was determined according to the instruction manual of the BNP test kit. All patients had 3 ml of fasting venous blood drawn before and after the experiment, and after centrifugation at 3000 rpm at 4°C for 5 minutes, the upper plasma was taken and tested by a dedicated person.

[0181] 4. Criteria for judging efficacy

[0182] (1) Heart failure efficacy score (Lee's heart failure scoring method), as follows:

[0183] Table 1 Lee's heart failure scoring system

[0184]

[0185] The efficacy criteria are:

[0186] ① After markedly effective treatment, the score is reduced by 75%;

[0187] ② After effective treatment, the score is reduced by 50%-75%;

[0188] ③ The score decreases by less than 50% after ineffective treatment;

[0189] ④ The score after treatment worsens and exceeds the score before treatment.

[0190] (2) Assessment of patients’ quality of life: The Minnesota Heart Failure Quality of Life Questionnaire was used. The details are as follows:

[0191] Table 2 Minnesota Quality of Life Questionnaire for Heart Failure Patients

[0192]

[0193] (3) The criteria for judging the comprehensive efficacy of TCM symptoms were formulated with reference to the “Guidelines for Clinical Research on New Chinese Medicines for the Treatment of Heart Failure”, as shown in Table 3 for details.

[0194] ① Significant effect: After treatment, the main and secondary symptoms of TCM clinical practice basically disappeared or decreased by ≥70%

[0195] ②Effective: After treatment, the TCM symptom score is reduced by ≥30%

[0196] ③ Ineffective: The TCM symptom score decreased by less than 30% after treatment

[0197] ④Aggravation: The TCM score after treatment is greater than that before treatment.

[0198] Table 3 TCM symptom scoring standards

[0199]

[0200]

[0201]

[0202] 4. Statistical analysis methods

[0203] Measurement data are presented as mean ± standard deviation The comparison between the two groups was performed by the t-test for independent sample means; the comparison before and after treatment within the group was performed by the t-test for paired design data. 2 SPSS 17.0 statistical software was used for analysis, and P < 0.05 was considered statistically significant.

[0204] IV. Research Results

[0205] 1. Analysis of clinical data

[0206] The patients' general clinical data including age, gender, NYHA cardiac function classification, etc.

[0207] Table 4 Comparison of general clinical data of patients

[0208]

[0209] Before the experiment, there was no significant difference in general clinical data such as age, gender, and NYHA cardiac function classification between the control group and the observation group (P>0.05), and they were comparable.

[0210] (II) Comparison of 6MWT distance before and after treatment

[0211] After treatment, the 6MWT distance of patients was significantly prolonged compared with that before treatment, indicating that the Wenyang Yiqi prescription can prolong the 6MWT distance of CHF patients and improve their exercise tolerance, see Table 5.

[0212] Table 5 6MWT distance of patients before and after treatment

[0213]

[0214] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0215] After treatment, the 6MWT heart failure grade of patients was significantly improved compared with that before treatment; the comparison of 6MWT heart failure grade showed that the observation group was effective in improving the 6MWT heart failure grade of CHF patients, see Table 6.

[0216] Table 6 Comparison of 6WMT cardiac function classification of patients before and after treatment (cases)

[0217]

[0218]

[0219] (III) Comparison of BNP levels before and after treatment

[0220] After treatment, the BNP level of patients was significantly lower than that before treatment, indicating that the observation group can effectively reduce the BNP level of patients and improve cardiac function, see Table 7.

[0221] Table 7 Comparison of BNP between the two groups before and after treatment

[0222]

[0223] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0224] (IV) Comparison of Lee's heart failure scores before and after treatment

[0225] After treatment, the Lee score of patients with heart failure was significantly lower than that before treatment, indicating that the observation group can improve the Lee score of patients with heart failure (see Table 8).

[0226] Table 8 Lee's heart failure score before and after treatment

[0227]

[0228] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0229] The total effective rate of the observation group was 80.00%, see Table 9.

[0230] Table 9 Comparison of efficacy of Lee's heart failure after treatment

[0231]

[0232] 5. Comparison of improvement in patients’ quality of life before and after treatment

[0233] After treatment, the patient's quality of life score was significantly lower than that before treatment, indicating that the observation group can improve the quality of life of CHF patients, see Table 9.

[0234] Table 10 Minnesota scores of patients before and after treatment

[0235]

[0236] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0237] (VI) Comparison of improvement of TCM symptoms in patients before and after treatment

[0238] After treatment, the TCM symptom scores of patients were significantly lower than those before treatment, indicating that the observation group can improve the TCM symptoms of CHF patients, see Table 11.

[0239] Table 11 TCM symptom scores of patients before and after treatment

[0240]

[0241] (VII) Analysis of safety indicators

[0242] During the clinical observation, no significant changes were found in the blood, urine, stool routine, electrolyte levels, liver and kidney function, and electrocardiogram of the two groups of patients before and after treatment. No obvious adverse reactions occurred.

[0243] Table 12 Comparison of ALT in liver and kidney function between the two groups of patients

[0244]

[0245] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0246] Table 13 Comparison of AST in liver and kidney function between the two groups of patients

[0247]

[0248]

[0249] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0250] Table 14 Comparison of urea in liver and kidney function between the two groups of patients

[0251]

[0252] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0253] Table 15 Comparison of creatinine in liver and kidney function between the two groups of patients

[0254]

[0255] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0256] As can be seen from Tables 12-15, there was no significant difference in ALT, AST, urea and creatinine in liver and kidney function between the two groups of patients (P>0.05).

[0257] Table 16 Comparison of white blood cells in blood routine of two groups of patients

[0258]

[0259] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0260] Table 17 Comparison of cells in blood routine of two groups of patients

[0261]

[0262] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0263] Table 18 Comparison of platelets in blood routine test between the two groups of patients

[0264]

[0265] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0266] Table 19 Comparison of white blood cells in urine routine of two groups of patients

[0267]

[0268] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0269] Table 20 Comparison of red blood cells in urine routine of two groups of patients

[0270]

[0271] Note: Compared with the control group, @ P < 0.05, *P < 0.01;

[0272] As can be seen from Tables 16-20, there was no significant difference in the indicators of blood routine and urine routine between the two groups of patients (P>0.05).

[0273] The results of this clinical study show that Wenyang Yiqi prescription can significantly prolong the 6WMT distance of CHF patients, improve patients' exercise tolerance, reduce plasma BNP levels, improve heart failure efficacy scores, reduce TCM symptom scores, and improve patients' quality of life. It has a definite effect and no obvious toxic side effects. It exerts functional regulation and therapeutic effects from multiple links, multiple levels, and multiple targets. This is the mechanism and advantage of this prescription. This medicine has been systematically clinically studied, simulating the characteristics of clinical decoctions, retaining all the characteristics and effective ingredients of the original Chinese medicine pieces, and preparing them into granules. It is easy to carry, easy to take, clean and hygienic. It is clinically used to treat heart failure of deficiency of heart qi, and has reliable efficacy.

Claims

1. A Chinese medicine composition for treating chronic heart failure, characterized in that: The Chinese medicine composition is made from the following Chinese medicines: 40-60 weight parts of Rosa laevigata, 20-40 weight parts of Astragalus, 2-8 weight parts of Caulis Piperis, 2-8 weight parts of Leech, 5-15 weight parts of Ginseng, 5-15 weight parts of Lepidium, 8-20 weight parts of Angelica, 5-16 weight parts of Schizonepeta, 5-16 weight parts of Saposhnikovia, 4-15 weight parts of Cassia twig, 10-25 weight parts of Poria, 8-20 weight parts of Atractylodes, and 3-10 weight parts of Licorice.

2. The Chinese medicine composition according to claim 1, characterized in that The scutellaria baicalensis seeds are stir-fried scutellaria baicalensis seeds, and the atractylodes macrocephala is stir-fried atractylodes macrocephala with bran.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is made from the following Chinese medicines: 60 parts by weight of Rosa rugosa, 40 parts by weight of Astragalus, 8 parts by weight of Caulis Piperis, 8 parts by weight of Hirudo, 15 parts by weight of Ginseng, 15 parts by weight of Stir-fried Leonurus japonicus, 20 parts by weight of Angelica sinensis, 16 parts by weight of Schizonepeta tenuifolia, 16 parts by weight of Saposhnikovia divaricata, 15 parts by weight of Cinnamon twig, 25 parts by weight of Poria, 20 parts by weight of Stir-fried Atractylodes macrocephala with bran, and 10 parts by weight of Licorice.

4. The Chinese medicine composition as claimed in claim 2, characterized in that The Chinese medicine composition is made from the following Chinese medicines: 40 parts by weight of Rosa rugosa, 20 parts by weight of Astragalus, 2 parts by weight of Caulis Piperis, 2 parts by weight of Hirudo, 5 parts by weight of Ginseng, 5 parts by weight of Stir-fried Leonurus, 8 parts by weight of Angelica sinensis, 5 parts by weight of Schizonepeta tenuifolia, 5 parts by weight of Saposhnikovia divaricata, 4 parts by weight of Cinnamon twig, 10 parts by weight of Poria, 8 parts by weight of Stir-fried Atractylodes macrocephala with bran, and 3 parts by weight of Licorice.

5. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is made from the following Chinese medicines: 50 parts by weight of Rosa rugosa, 30 parts by weight of Astragalus, 5 parts by weight of Caulis Piperis, 5 parts by weight of Hirudo, 9 parts by weight of Ginseng, 9 parts by weight of Stir-fried Leonurus japonicus, 12 parts by weight of Angelica sinensis, 10 parts by weight of Schizonepeta tenuifolia, 10 parts by weight of Saposhnikovia divaricata, 9 parts by weight of Cinnamon twig, 15 parts by weight of Poria, 12 parts by weight of Stir-fried Atractylodes macrocephala with bran, and 6 parts by weight of Licorice.

6. Use of the Chinese medicine composition according to any one of claims 2 to 5 in the preparation of a drug for treating chronic heart failure.

7. A Chinese medicine preparation prepared from the Chinese medicine composition according to any one of items 2-5, characterized in that: The Chinese medicine oral preparation is any one of decoction, tablet, capsule and granule.

8. A method for preparing the decoction as claimed in claim 7, characterized in that: The method comprises the following steps: 1) Add 10-20 times the amount of water to stir-fried radix scutellariae, ginseng, angelica, tuckahoe, rosa laevigata, astragalus, stir-fried atractylodes macrocephala and licorice, decoct for 30-40 minutes, filter, and set aside the filtrate and residue; add 4-8 times the amount of water to the residue, decoct for 15-25 minutes, filter, and combine the two filtrates; set aside; 2) Crush Nepeta, Saposhnikovia, Cinnamomum cassia, Caulis Piperis and Leech, add 75% ethanol and reflux extract twice, combine the filtrate and set aside; 3) The filtrates from steps 2) and 3) are combined and concentrated at 60-70° C. to a relative density of 1.08-1.13 to obtain a decoction.

9. A method for preparing the granules according to claim 7, characterized in that: The method comprises the following steps: 1) Crush the leeches through a 16-mesh sieve, and prepare the leech powder for later use; 2) Add 10-20 times the amount of water to the stir-fried radix scutellariae, ginseng, angelica, tuckahoe, rosa laevigata, astragalus, stir-fried atractylodes macrocephala and licorice, boil for 30-40 minutes, filter, and set aside the filtrate and residue; add 4-8 times the amount of water to the residue, boil for 15-25 minutes, filter, and combine the two filtrates; set aside; 3) Crush Nepeta, Saposhnikovia, Cinnamomum cassia, Caulis Piperis and Leech, add 75% ethanol and reflux extract twice, combine the filtrate and set aside; 4) combining the filtrates from step 2) and step 3), concentrating at 60-70° C. to a relative density of 1.05-1.11, standing for 6-12 hours, taking the supernatant, adding leech powder, concentrating at 65-75° C. to a relative density of 1.25-1.35, and obtaining a concentrated solution for standby use; 5) Add 3 times the total weight of the concentrate into a mixture of dextrin and sucrose in step 4), granulate, and dry to obtain the product.

10. The chronic heart failure according to any one of claims 1 or 2-7 is characterized by deficiency of heart qi, blood stasis and water retention.

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