Traditional Chinese medicine composition for treating chronic heart failure as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating chronic heart failure and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from American ginseng, rhodiola rosea, astragalus membranaceus, carthamus tinctorius, morinda officinalis, radix ophiopogonis, salvia miltiorrhiza, platycladi seeds, semen lepidii and schisandra chinensis. The traditional Chinese medicine composition disclosed by the invention has the effects of warming and tonifying yang qi and inducing diuresis to alleviate edema, is mainly used for treating yang-deficiency edema and heart-qi deficiency type cardiovascular diseases, and is particularly suitable for patients suffering from chronic heart failure. Besides, on the basis of a traditional medical formula, a modern preparation process is utilized and deeply optimized, granules of the traditional Chinese medicine composition are developed, and the preparation method of the traditional Chinese medicine composition and the preparation thereof has the advantages that the preparation process is simple and convenient, efficient and energy-saving, and effective components are hardly damaged; wide clinical application prospects and economic values are realized.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating chronic heart failure, a preparation method and use thereof. Background Art

[0002] Heart failure diseases discussed in modern medicine are mostly scattered among diseases such as heart water, heart paralysis, heart swelling, wheezing, edema, palpitations, phlegm and fluid. According to its symptoms, the earliest record can be found in "Suwen·Bi Lun Pian": "When the pulse is paralyzed, it is affected by the evil and stays in the heart... The pulse is blocked, the heart is bulging when it is upset, and it is panting suddenly. The throat is dry and prone to belching, and fear arises when the cold qi rises." This discussion on heart paralysis is similar to the chronic heart failure caused by rheumatic heart disease in modern medicine. Because this discussion is very similar to the symptoms of chronic heart failure, some scholars believe that heart paralysis is the earliest name for chronic heart failure in traditional Chinese medicine. The Yellow Emperor's Classic of Internal Medicine discusses heart swelling as follows: "Heart swelling causes restlessness, shortness of breath, and inability to sleep." Zhang Zhongjing's Golden Chamber Synopsis: Water Qi Disease Pulse Symptoms and Treatments discusses heart water as follows: "Heart water causes a heavy body and shortness of breath, inability to sleep, restlessness and irritability, and swollen genitals." The symptoms discussed in these two paragraphs are very similar to heart failure in modern medicine. In addition, the discussion on water retention as "coughing, retching, shortness of breath, and inability to sleep" is also quite similar. Therefore, it is generally believed that the symptoms described in heart paralysis, heart swelling, and heart water are the same as today's heart failure.

[0003] In ancient times, the treatment of this disease was mostly scattered among symptoms such as palpitations, edema, and wheezing. Ancient doctors mainly used the methods of invigorating qi and warming yang, resolving phlegm and relieving wheezing, promoting diuresis and reducing edema, promoting blood circulation and removing blood stasis, warming the kidney and strengthening yang, and draining the lungs and expelling water for treatment. For example, "Golden Chamber Synopsis: Chest Bi, Heart Pain, Shortness of Breath, Pulse and Treatment" says: "For chest bi, wheezing, coughing, spitting, chest and back pain, shortness of breath, deep and slow pulse at Cunkou, small and tight pulse at Guanshang, Gualou Xiebai Baijiu Tang is the main treatment.", and "Medical Ancestor Golden Mirror" says: "Water stagnation under the heart, severe palpitations, has been clearly treated. Shortness of breath due to slight drinking is due to water stagnation that hinders breathing and is short. Use Ling Gui Shu Gan Tang to clear the yang, and when the yang qi is clear, the orifice of the bladder will be clear. Shenqi Pills warm the yang qi to move water. Although the main functions are different, they are also beneficial to urination." It is believed that it should be treated by warming yang and promoting diuresis.

[0004] In the process of treating this disease, modern doctors combine the knowledge of Chinese and Western medicine and practical experience. According to the different stages and types of this disease, the treatment and research of this disease mainly include syndrome differentiation and treatment and disease-specific prescription treatment, and use modern scientific methods to analyze drugs and study the mechanism of drug action. "Diagnosis and Treatment of Cardiovascular and Cerebrovascular Diseases in Traditional Chinese Medicine" divides heart failure into four syndromes: insufficient heart qi, heart yin deficiency syndrome, spleen and kidney yang deficiency, water and food indigestion syndrome, qi deficiency and blood stasis, phlegm and dampness obstruction syndrome, phlegm and fluid obstruction of the lungs, airway unfavorable syndrome, and respectively give Tingli Shengmai Wuling Powder, Zhenwu Decoction, Xuefu Zhuyu Decoction, Tingli Dazao Xiefei Decoction combined with Xiebai Powder for treatment. "Chinese Medical Treatment for Difficult Diseases in Internal Medicine" divides heart failure into qi and yin deficiency syndrome, which is treated with Shengmai San combined with Zhigancao Tang, yang deficiency and water retention syndrome is treated with Zhenwu Tang combined with Lingguishugan Tang, phlegm and turbidity syndrome is treated with Xiaoqinglong Tang combined with Tingli Dazaoshao Xiefei Tang, blood vessel blockage syndrome is treated with Xuefu Zhuyu Tang combined with Wuling San, and yin exhaustion and yang loss syndrome is treated with Shenfu Longmu Tang combined with Shenge San.

[0005] At present, there are many Chinese patent medicines and Chinese herbal prescriptions used in the clinic to treat chronic heart failure, but most of them have defects such as unsatisfactory treatment effects and slow onset of action. In addition, although the use of Chinese herbal decoctions can be adjusted individually according to the actual situation of the patient, Chinese herbal decoctions are heavy in taste and may irritate the gastrointestinal tract, and are inconvenient to carry, resulting in poor compliance of patients with medication, making it difficult for patients to persist in long-term use.

[0006] In view of this, the present invention adopts modern pharmacological research methods, conducts in-depth research on Zhongjing's classic prescription Tingli Dazaoshaifei Decoction, adds drugs such as Rhodiola rosea, and develops a new Chinese medicine composition and Chinese patent medicine preparation method for effectively treating chronic heart failure, targeting the basic pathogenesis of yang deficiency, water overflow and insufficient heart qi in patients with chronic heart failure. Summary of the invention

[0007] In order to solve the above technical problems, the present invention provides a Chinese medicine composition for treating chronic heart failure, and a preparation method and use thereof.

[0008] Specifically, the present invention is realized through the following technical solutions:

[0009] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic heart failure, which is prepared from the following raw materials in parts by weight: 1-30 parts of American ginseng, 5-40 parts of Rhodiola rosea, 5-40 parts of Astragalus, 1-30 parts of Carthamus tinctorius, 1-30 parts of Morinda officinalis, 1-30 parts of Ophiopogon japonicus, 5-40 parts of Salvia miltiorrhiza, 1-30 parts of Platycladus orientalis, 10-50 parts of Lepidium ilicis seeds, and 1-10 parts of Schisandra chinensis.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 5-20 parts of American ginseng, 20-30 parts of Rhodiola rosea, 20-30 parts of Astragalus, 5-20 parts of Carthamus tinctorius, 5-20 parts of Morinda officinalis, 5-20 parts of Ophiopogon japonicus, 20-30 parts of Salvia miltiorrhiza, 5-20 parts of Platycladus orientalis, 20-40 parts of Lepidium ilicis seeds, and 2-8 parts of Schisandra chinensis.

[0011] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 15 parts of American ginseng, 25 parts of Rhodiola rosea, 25 parts of Astragalus, 15 parts of Carthamus tinctorius, 15 parts of Morinda officinalis, 15 parts of Ophiopogon japonicus, 25 parts of Salvia miltiorrhiza, 15 parts of Platycladus orientalis, 30 parts of Lepidium ilicis seeds, and 5 parts of Schisandra chinensis.

[0012] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition described in the first aspect, the preparation method comprising the following steps:

[0013] (1) 6-10 times the amount of 75% ethanol was taken from the prescribed amount of American ginseng, safflower, Morinda officinalis and Salvia miltiorrhiza, and refluxed twice to obtain an alcohol extract and a drug residue, the alcohol extract was concentrated under reduced pressure to a thick paste with a relative density of 1.10-1.20, the thick paste was dried under reduced pressure to obtain a dry paste, and the dry paste was crushed and sieved;

[0014] (2) boiling the residues in step (1) with 10-15 times the amount of water in the prescribed amount of Rhodiola rosea, Semen Lepidii, Semen Platycladi and Fructus Schisandrae Chinensis for three times, concentrating the aqueous extract under reduced pressure to a thick paste with a relative density of 1.20-1.30, drying the thick paste under reduced pressure to obtain a dry paste, and crushing and sieving the dry paste;

[0015] (3) Mix the pulverized dry pastes obtained in step (1) and step (2), add the prescribed amount of astragalus powder and ophiopogon powder, and then add appropriate amounts of dextrin and cyclamate, and wet and granulate with 95% ethanol to prepare the granules of the traditional Chinese medicine composition.

[0016] As an optional manner, in the above preparation method, in step (1) and step (2), the time for each reflux extraction and each water decoction is 1 hour, and the conditions for reduced pressure concentration and reduced pressure drying are both 70°C and the vacuum degree is 0.07-0.08MPa.

[0017] As an optional manner, in the above preparation method, in steps (1) to (3), the dry paste is sieved through a 100-mesh sieve after being crushed, and the astragalus powder and ophiopogon powder are sieved through a 100-mesh sieve before mixing.

[0018] As an optional manner, in the above preparation method, in step (1), 8 times the amount of 75% ethanol is added, and in step (2), 12.5 times the amount of water is added.

[0019] In a third aspect, the present invention provides use of the Chinese medicine composition described in the first aspect or the Chinese medicine composition prepared by the preparation method described in the second aspect in preparing a drug for treating chronic heart failure.

[0020] As an optional mode, in the above-mentioned use, the drug has the effects of warming and replenishing Yang Qi, promoting diuresis and reducing swelling, and is used to treat chronic heart failure of Yang deficiency, water retention, and insufficient heart Qi type.

[0021] As an optional mode, in the above-mentioned use, the dosage form of the drug is granules, tablets, oral liquid or capsules.

[0022] As an optional mode, in the above-mentioned use, the dosage form of the drug is granules.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] The Chinese medicine composition of the present invention has the effects of warming and replenishing Yang Qi, promoting diuresis and reducing swelling, and is mainly used to treat cardiovascular diseases of Yang deficiency and water flooding and insufficient heart Qi, and is particularly suitable for patients with chronic heart failure with the above symptoms. In addition, on the basis of traditional medical prescriptions, the present invention utilizes modern preparation technology and performs in-depth optimization to develop granules of the Chinese medicine composition of the present invention. The preparation method of the Chinese medicine composition and its preparation of the present invention has the advantages of simple preparation technology, high efficiency, energy saving, and less destruction of effective ingredients, and has broad clinical application prospects and economic value. DETAILED DESCRIPTION

[0025] The efficacy and main treatment of each medicinal ingredient in the Chinese medicine composition of the present invention are as follows:

[0026] As used herein, "American ginseng" refers to the root of Panax quinquefolium L., a plant of the Araliaceae family. It tastes sweet and slightly bitter, and is cool in nature. It enters the lung, heart, kidney, and spleen meridians. It has the effects of replenishing qi and nourishing yin, clearing away heat and promoting body fluid. It is mainly used to treat qi and yin damage, lung qi deficiency and lung yin deficiency, thirst due to qi deficiency and body fluid damage in febrile diseases, and polydipsia.

[0027] As used herein, "Rhodiola rosea" refers to the rhizome of Rhodiola rosea Limn. or Rhodiola euryphylla (Frod.) SHFu. of the Crassulaceae family. It is sweet in taste and cold in nature; it enters the spleen and lung meridians. It has the effects of strengthening the spleen and replenishing qi, clearing the lungs and relieving cough, and promoting blood circulation and removing blood stasis. It is mainly used to treat spleen deficiency syndrome, lung yin deficiency, and lung heat cough.

[0028] As used herein, "Huangqi" refers to the root of Astragalus memeranaceus (Fisch.) Bge. Var. mongholicus (Bge.) Hsiao or A. membranaceus (Fisch.) Bge. of the genus Astragalus in the Leguminosae family. It is sweet in taste and slightly warm in nature; it enters the spleen and lung meridians. It has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting the sunken, strengthening the body's defense system, promoting urination, and removing toxins and promoting muscle regeneration. It is mainly used to treat spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal or ulcers that are difficult to heal for a long time, etc.

[0029] As used herein, "safflower" refers to the dried flowers of Carthamus tinctorius L., a plant of the genus Carthamus in the Asteraceae family. It is pungent in taste, warm in nature, and enters the heart and liver meridians. It has the effects of promoting blood circulation and dredges the menstruation, removing blood stasis and relieving pain. It is mainly used to treat blood stasis, amenorrhea, dysmenorrhea, abdominal pain due to postpartum stasis, accumulation of lumps and masses, chest pain, abdominal pain due to blood stasis, hypochondriasis, traumatic injury, swelling and pain due to stasis, and dark color of stasis rash.

[0030] As used herein, "Morinda officinalis" is the root of Morinda officinalis How., a plant of the Rubiaceae family. It is pungent and sweet, slightly warm in nature, and enters the kidney and liver meridians. It has the effects of tonifying the kidney and yang, dispelling wind and removing dampness. It is mainly used to treat impotence, infertility due to uterine coldness, frequent urination, rheumatic pain in the waist and knees, and soreness of the waist and knees due to kidney deficiency.

[0031] As used herein, "Ophiopogon japonicus" is a perennial evergreen herb of the genus Ophiopogonis in the family Liliaceae. It tastes sweet and slightly bitter, is slightly cold in nature, and enters the stomach, lung, and heart meridians. It has the effects of promoting fluid production and quenching thirst, moistening the lungs and relieving cough. It is mainly used to treat dry cough due to lung dryness, tuberculosis due to yin deficiency, sore throat due to throat numbness, thirst due to fluid loss, internal heat and thirst, restlessness and insomnia, and constipation due to dry intestines.

[0032] As used herein, "Danshen" refers to the dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the genus Salvia in the family Lamiaceae. It tastes bitter and is slightly cold in nature; it enters the heart, pericardium, and liver meridians. It has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and relieving pain, cooling blood and eliminating carbuncle, and removing restlessness and calming the mind. It is mainly used to treat irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to postpartum stasis, heart pain due to blood stasis, abdominal pain, accumulation of lumps and masses, injuries from falls, rheumatic arthralgia, sores, carbuncle, swelling and poison, irritability and coma due to fever, palpitations and insomnia.

[0033] As used herein, "Platycladus orientalis kernel" refers to the dried mature kernel of Platycladus orientalis (L.) Franco, a plant of the Cupressaceae family. It is sweet in taste and neutral in nature; it enters the heart, kidney, and large intestine meridians. It has the effects of nourishing the heart and calming the mind, moistening the intestines and relieving constipation. It is mainly used to treat palpitations, insomnia, and constipation caused by dry intestines.

[0034] As used herein, "Tinglizi" refers to the dried mature seeds of Descurainia sophia (L.) Webb. ex Prantl. or Lepidium apetalum Willd. of the cruciferous family. It tastes bitter and pungent, is very cold in nature, and enters the lung and bladder meridians. It has the effects of purging the lungs and relieving asthma, promoting water circulation and reducing swelling. It is mainly used to treat phlegm and saliva blocking the lungs, asthma, coughing and sputum, chest and flank distension, inability to lie flat, chest and abdominal edema, and difficulty urinating.

[0035] As used herein, "Schisandra chinesis" refers to the mature fruit of Schisandra chinesis (Turcz.) Ball or Schisandra sphenanthera rehd.et Wils. of the Schisandra family. It is sour and sweet, warm in nature, and enters the lung, heart, and kidney meridians. It has the effects of astringing, strengthening qi, promoting body fluid, and tonifying the kidney and calming the mind. It is mainly used to treat chronic cough, asthenia, spontaneous sweating, night sweats, spermatorrhea, spermatorrhea, chronic diarrhea, thirst due to loss of body fluid, polydipsia, palpitations, insomnia, and dreaminess.

[0036] The present invention will be further described with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention.

[0037] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0038] The experimental methods in the following examples are all conventional methods unless otherwise specified. The experimental materials used in the following examples are all commercially available products unless otherwise specified. Preparation Examples:

[0039] Embodiment 1:

[0040] A traditional Chinese medicine composition for treating chronic heart failure, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of American ginseng, 25 parts of rhodiola rosea, 25 parts of astragalus, 15 parts of safflower, 15 parts of Morinda officinalis, 15 parts of ophiopogon japonicus, 25 parts of salvia miltiorrhiza, 15 parts of cypress seed, 30 parts of scutellaria baicalensis seeds, and 5 parts of schisandra chinensis.

[0041] The preparation method of the Chinese medicine composition comprises the following steps:

[0042] (1) Take 8 times the amount of 75% ethanol of American ginseng, safflower, Morinda officinalis and Salvia miltiorrhiza in the prescribed amount, reflux extract twice, each time for 1 hour, to obtain an alcohol extract and a drug residue, and reduce the pressure to concentrate the alcohol extract at 70° C. and a vacuum degree of 0.07-0.08 MPa to a thick paste with a relative density of 1.10-1.20, and then reduce the pressure to dry the thick paste at 70° C. and a vacuum degree of 0.07-0.08 MPa to obtain a dry paste, and the dry paste is crushed and passed through a 100-mesh sieve;

[0043] (2) boiling the residues in step (1) with 12.5 times the amount of water in the prescribed amount of Rhodiola rosea, Semen Lepidii, Semen Platycladi and Fructus Schisandrae Chinensis for three times, each time for 1 hour, concentrating the aqueous extract under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to a thick paste with a relative density of 1.20-1.30, and drying the thick paste under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to obtain a dry paste, which was crushed and passed through a 100-mesh sieve;

[0044] (3) Mix the pulverized dry pastes obtained in step (1) and step (2), add the prescribed amount of astragalus powder and ophiopogon powder passed through a 100-mesh sieve, add appropriate amounts of dextrin and cyclamate, moisten and granulate with 95% ethanol, and prepare the granules of the traditional Chinese medicine composition.

[0045] Comparative Example 1:

[0046] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of American ginseng, 25 parts of rhodiola rosea, 25 parts of astragalus, 15 parts of safflower, 15 parts of cistanche, 15 parts of ophiopogon, 25 parts of salvia miltiorrhiza, 15 parts of tuberculosis, 30 parts of leucophylla, and 5 parts of schisandra chinensis.

[0047] The preparation method of the Chinese medicine composition comprises the following steps:

[0048] (1) taking 8 times the amount of 75% ethanol of the prescribed amount of American ginseng, safflower, Cistanche deserticola and Salvia miltiorrhiza, reflux extraction twice, each time for 1 hour, to obtain an alcohol extract and a drug residue, the alcohol extract is concentrated under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to a thick paste with a relative density of 1.10-1.20, the thick paste is dried under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to obtain a dry paste, and the dry paste is crushed and passed through a 100-mesh sieve;

[0049] (2) boiling the residues in step (1) with 12.5 times the amount of water in the prescribed amount of Rhodiola rosea, Lemongrass seeds, Polygonum multiflorum and Schisandra chinensis for three times, each time for 1 hour, concentrating the aqueous extract under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to a thick paste with a relative density of 1.20-1.30, and drying the thick paste under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to obtain a dry paste, which was crushed and passed through a 100-mesh sieve;

[0050] (3) Mix the pulverized dry pastes obtained in step (1) and step (2), add the prescribed amount of astragalus powder and ophiopogon powder passed through a 100-mesh sieve, add appropriate amounts of dextrin and cyclamate, moisten and granulate with 95% ethanol, and prepare the granules of the traditional Chinese medicine composition.

[0051] Comparative Example 2:

[0052] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of American ginseng, 25 parts of rhodiola rosea, 25 parts of astragalus, 15 parts of safflower, 15 parts of Morinda officinalis, 15 parts of ophiopogon japonicus, 25 parts of salvia miltiorrhiza, 15 parts of cypress seeds, 30 parts of scutellaria baicalensis seeds, and 5 parts of schisandra chinensis.

[0053] The preparation method of the Chinese medicine composition comprises the following steps:

[0054] (1) Add 8 times the amount of 75% ethanol to the prescribed amount of American ginseng, safflower, Morinda officinalis, Salvia miltiorrhiza and Ophiopogon japonicus, perform reflux extraction twice, each time for 1 hour, to obtain an alcohol extract and a drug residue, and concentrate the alcohol extract under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to a thick paste with a relative density of 1.10-1.20, and then dry the thick paste under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to obtain a dry paste, and the dry paste is crushed and passed through a 100-mesh sieve;

[0055] (2) boiling the residues in step (1) with 12.5 times the amount of water in the prescribed amount of Rhodiola rosea, Semen Lepidii, Semen Platycladi and Fructus Schisandrae Chinensis for three times, each time for 1 hour, concentrating the aqueous extract under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to a thick paste with a relative density of 1.20-1.30, and drying the thick paste under reduced pressure at 70° C. and a vacuum degree of 0.07-0.08 MPa to obtain a dry paste, which was crushed and passed through a 100-mesh sieve;

[0056] (3) Mix the pulverized dry pastes obtained in step (1) and step (2), add the prescribed amount of astragalus powder sieved through a 100-mesh sieve, and then add appropriate amounts of dextrin and cyclamate, wet and granulate with 95% ethanol to prepare the granules of the traditional Chinese medicine composition.

[0057] Effect embodiment:

[0058] 1. Research content

[0059] In this study, a rat model of heart failure was established by in vivo injection of doxorubicin (ADR). Seven experimental groups were set up in the experiment, namely, a blank group, a model group, a western medicine control group, a traditional Chinese medicine control group, an example 1 group, a comparative example 1 group, and a comparative example 2 group. Each group was intervened with corresponding intervention factors, and then at the expected time point, cardiac function and electrocardiogram measurements were performed.

[0060] 2. Experimental subjects and reagents

[0061] Clean grade, healthy Wistar rats, male, weighing 250±20g, were purchased from the Experimental GLP Center of Heilongjiang University of Chinese Medicine. Animal husbandry environment: room temperature 20-22℃, free access to drinking water, and solid pellets.

[0062] (1) The drugs to be tested in Example 1 and Comparative Examples 1 to 2 were provided by the Chinese Medicine Preparation Laboratory of Heilongjiang University of Chinese Medicine. The preparation methods of the drugs to be tested are shown in the Preparation Examples section.

[0063] (2) Digoxin: 0.25 mg per tablet, national drug approval number H33021738, Hangzhou Sanofi-Aventis Minsheng Pharmaceutical Co., Ltd.

[0064] (3) Qili Qiangxin Capsules: 0.3 g per capsule, national drug approval number Z20040141, Shijiazhuang Yiling Pharmaceutical Co., Ltd.

[0065] 3. Experimental Methods

[0066] 3.1 Modeling method and animal grouping

[0067] Twelve Wistar male rats were randomly selected as the blank control group, and the remaining 100 rats were weighed and ADR was selected and dissolved in 1 mL of physiological saline at a dose of 3 mg / kg.

[0068] In water, intraperitoneal injection, once a week, for 6 weeks. The blank control group was injected with an equal volume of normal saline for 6 weeks. The feed was a standard synthetic rat feed, all provided by the GLP Center of Heilongjiang University of Chinese Medicine. After successful modeling, the animals (72 in total) were randomly divided into 6 groups, namely, the model group, the Chinese medicine control group (Qili Qiangxin Capsule), the Western medicine control group (Digoxin), the embodiment 1 group, the comparative example 1 group, and the comparative example 2 group, with 12 in each group.

[0069] 3.2 Administration

[0070] After the modeling was completed, the animals were gavaged once every morning at the following doses: Example 1 group (3.0 g / kg / d), Comparative Example 1 group (3.0 g / kg / d), Comparative Example 2 group (3.0 g / kg / d), the Western medicine control group was given digoxin, the dosage was (0.2 mg / kg / d), and the Chinese medicine control group was given Qili Qiangxin Capsule (3.0 g / kg / d). The above dosages were converted according to the equivalent dose per kilogram of body weight of human / mouse, and were all added to 3 mL of normal saline. The normal control group and the model control group were given the same volume of normal saline, once a day, for 28 consecutive days. Rats in each group were fed with free drinking water and ordinary feed.

[0071] 3.3 Index detection

[0072] Observation of general condition; in vivo electrocardiogram measurement of rats; cardiac function measurement of rats.

[0073] 3.4 Statistical analysis methods

[0074] SPSS 23.0 statistical software was used for data analysis. The measurement data were expressed as mean ± standard deviation (mean ± SD). One-way ANOVA was used for comparison among multiple groups. LSD test was used for equal variance test, and Euskal-Walli SH method was used for non-parametric test for unequal variance. P < 0.05 was considered as statistically significant difference.

[0075] The difference is statistically significant.

[0076] 4. Experimental Results

[0077] 4.1 General observation of experimental rats

[0078] Throughout the experiment, the rats in the blank group grew normally, in line with the natural growth pattern of conventional rats, and their diet, weight, hair quality and color, mental state and activity were normal, and there was no death. For the Wistar male rats that replicated the model, the rats began to have a poor mental state and showed a disease state after the third week of model preparation. Their hair color was dull and messy, and the original smooth hair state disappeared. Hair loss appeared all over the body or locally. The rats ate less, had reduced activity, were listless, liked to be quiet and disliked movement, and gathered in groups. The overall mental state was poor, weight gain slowed down, and some rats lost weight. In the middle and late stages, rats developed ascites, urine volume decreased significantly, and cyanosis appeared on the lips and toes. The overall state of the rats indicated that the chronic heart failure model was successfully replicated.

[0079] A total of 72 rats were successfully modeled. After grouping, the condition of the rats in the model group did not improve significantly. The general condition of the rats in each treatment group improved to varying degrees, but did not return to the health level of the blank group, showing varying degrees of weight loss, lips, toe cyanosis and other heart failure symptoms. At the end of the experiment, all rats except the blank group died. Finally, 12 rats in the blank group, 9 in the model group, 10 in the western medicine control group, 10 in the traditional Chinese medicine control group, 10 in the embodiment 1 group, 9 in the comparative example 1 group, and 10 in the comparative example 2 group were included in the specimen collection.

[0080] 4.2 Effects on echocardiography in rats with chronic heart failure

[0081] Through the study of cardiac echocardiography of rats in the blank group, chronic heart failure model group, western medicine control group, traditional Chinese medicine control group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 groups, it was found that the model group rats had significant changes in cardiac function compared with the blank group rats, and compared with the model group, each control group and treatment group was found to have different degrees of effect of various drug interventions, but the degree of recovery of various indicators was not as good as that of the blank group rats, indicating that ADR-induced cardiac damage is irreversible.

[0082] As shown in Table 1, through comprehensive analysis and comparison of EF and FS of each group, it was found that Example 1 can significantly improve the cardiac function of experimental animals, and its therapeutic effect is slightly better than that of the Chinese medicine control group and the Western medicine control group. However, the effects of Comparative Examples 1 to 2 in improving cardiac function are significantly inferior to those of Example 1, which shows that the various medicinal flavors in the Chinese medicine composition of the present invention and the preparation method of the Chinese medicine composition play an important role in the therapeutic effect of the Chinese medicine composition of the present invention.

[0083] Table 1: Echocardiographic parameters detected in rats with chronic heart failure

[0084]

[0085] Note: Compared with the blank group, (1) P < 0.01; compared with the model group, (2) P < 0.01; compared with the Chinese medicine control group, (3) P < 0.01, (5) P < 0.05, (6) P > 0.05; compared with the Western medicine control group, (4) P < 0.05, (7) P > 0.05.

[0086] 4.3 Effects on cardiac hemodynamics in rats with chronic heart failure

[0087] The effects of multi-channel electrophysiological recorder on cardiac hemodynamics of rats in the blank group, chronic heart failure model group, western medicine control group, traditional Chinese medicine control group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 groups were studied. It was found that compared with the blank group, the cardiac hemodynamics LVSP, LVEDP, and ±dp / dtmax of the model group rats were significantly changed. Combined with the results of cardiac ultrasound examination and the changes in myocardial pathological morphology, the model was successfully replicated. Comparative study of the results of each treatment group, control group, and model group found that drug intervention had a certain therapeutic effect, but the recovery degree of the rats was not as good as that of the blank group rats, indicating that ADR-induced cardiac damage is irreversible.

[0088] As shown in Table 2, through comprehensive analysis and comparison of the LVSP, LVEDP and ±dp / dtmax of each group, it was found that Example 1 can significantly improve the heart failure of experimental animals, and its therapeutic effect is better than that of the Chinese medicine control group and the Western medicine control group. However, the effects of Comparative Examples 1 to 2 in improving heart failure are significantly inferior to those of Example 1, which shows that the various medicinal flavors in the Chinese medicine composition of the present invention and the preparation method of the Chinese medicine composition play an important role in the therapeutic effect of the Chinese medicine composition of the present invention.

[0089] Table 2: Test results of rat cardiac hemodynamic indicators

[0090]

[0091]

[0092] Note: Compared with the blank group, (1) P < 0.01; compared with the model group, (2) P < 0.01; compared with the Chinese medicine control group, (3) P < 0.01, (5) P < 0.05, (6) P > 0.05; compared with the Western medicine control group, (4) P < 0.05, (7) P > 0.05.

[0093] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition for treating chronic heart failure, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-30 parts of American ginseng, 5-40 parts of rhodiola rosea, 5-40 parts of astragalus, 1-30 parts of safflower, 1-30 parts of Morinda officinalis, 1-30 parts of ophiopogon japonicus, 5-40 parts of salvia miltiorrhiza, 1-30 parts of cyperus arvense seeds, 10-50 parts of schisandra chinensis seeds, and 1-10 parts of schisandra chinensis.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-20 parts of American ginseng, 20-30 parts of rhodiola rosea, 20-30 parts of astragalus, 5-20 parts of safflower, 5-20 parts of Morinda officinalis, 5-20 parts of ophiopogon japonicus, 20-30 parts of salvia miltiorrhiza, 5-20 parts of cypress seeds, 20-40 parts of schisandra chinensis seeds, and 2-8 parts of schisandra chinensis.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of American ginseng, 25 parts of rhodiola rosea, 25 parts of astragalus, 15 parts of safflower, 15 parts of Morinda officinalis, 15 parts of ophiopogon japonicus, 25 parts of salvia miltiorrhiza, 15 parts of cypress seeds, 30 parts of scutellaria baicalensis seeds, and 5 parts of schisandra chinensis.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: (1) 6-10 times the amount of 75% ethanol was taken from the prescribed amount of American ginseng, safflower, Morinda officinalis and Salvia miltiorrhiza, and refluxed twice to obtain an alcohol extract and a drug residue, the alcohol extract was concentrated under reduced pressure to a thick paste with a relative density of 1.10-1.20, the thick paste was dried under reduced pressure to obtain a dry paste, and the dry paste was crushed and sieved; (2) boiling the residues in step (1) with 10-15 times the amount of water in the prescribed amount of Rhodiola rosea, Semen Lepidii, Semen Platycladi and Fructus Schisandrae Chinensis for three times, concentrating the aqueous extract under reduced pressure to a thick paste with a relative density of 1.20-1.30, drying the thick paste under reduced pressure to obtain a dry paste, and crushing and sieving the dry paste; (3) Mix the pulverized dry pastes obtained in step (1) and step (2), add the prescribed amount of astragalus powder and ophiopogon powder, and then add appropriate amounts of dextrin and cyclamate, and wet and granulate with 95% ethanol to prepare the granules of the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that: In step (1) and step (2), the time for each reflux extraction and each water decoction is 1 hour, and the conditions for reduced pressure concentration and reduced pressure drying are both 70° C. and the vacuum degree is 0.07-0.08 MPa.

6. The preparation method according to claim 4, characterized in that: In steps (1) to (3), the dry paste is sieved through a 100-mesh sieve after being crushed, and the astragalus powder and ophiopogon powder are sieved through a 100-mesh sieve before being mixed.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 6 in the preparation of a medicament for treating chronic heart failure.

8. The use according to claim 7, characterized in that: The medicine has the effects of warming and replenishing yang qi, promoting diuresis and reducing swelling, and is used for treating chronic heart failure of yang deficiency, water flooding and insufficient heart qi type.

9. The use according to claim 7 or claim 8, characterized in that: The dosage form of the medicine is granules, tablets, oral liquid or capsules.

10. The use according to claim 9, characterized in that: The dosage form of the medicine is granules.

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