CN116098960A

CN116098960A - Traditional Chinese medicine composition for treating chronic heart failure as well as preparation method and application thereof

Info

Publication number: CN116098960A
Application number: CN202111328709.0A
Authority: CN
Inventors: 李倩; 范建伟; 申凤霞
Original assignee: Shandong New Time Pharmaceutical Co Ltd
Current assignee: Shandong New Time Pharmaceutical Co Ltd
Priority date: 2021-11-10
Filing date: 2021-11-10
Publication date: 2023-05-12

Abstract

The invention relates to a traditional Chinese medicine composition, a preparation method and application thereof, and belongs to the field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from 10 raw medicinal materials including snakegourd fruit, dwarf lilyturf tuber, cassia twig, chinese angelica, platycodon root, szechuan lovage rhizome, indian buead, costustoot, liquoric root and Chinese magnoliavine fruit. According to the compatibility theory of monarch, minister, assistant and guide and drug pair, the composition disclosed by the invention combines the drugs, has the effects of relieving chest stuffiness, eliminating phlegm, warming channels, dispelling cold, promoting qi circulation and relieving pain, has the characteristics of definite curative effect, quick response, high cure rate, no side effect and the like, has the effects of relieving chest stuffiness, eliminating phlegm, warming channels, dispelling cold and promoting qi circulation and relieving pain, and provides a new choice for clinically treating chronic heart failure.

Description

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

Technical Field

The invention belongs to the field of traditional Chinese medicines, discloses a traditional Chinese medicine composition, a preparation method and application thereof, and in particular discloses a traditional Chinese medicine composition for treating chronic heart failure, a preparation method and application thereof

Background

Chronic heart failure, abbreviated as chronic heart failure, is a complex clinical syndrome, which is caused by the change of heart structure and function due to the initial myocardial injury of various reasons, and finally leads to the hypofunction of ventricular pump blood, at which time the heart can not pump enough blood to meet the requirement of tissue metabolism, or can pump the corresponding blood volume required by tissue metabolism only after the filling pressure is increased. Heart failure is a clinically common critical disorder, often a major complication of organic heart diseases of all different etiologies, and is characterized clinically by dyspnea, hypodynamia, impaired exercise tolerance, pulmonary congestion and peripheral edema caused by body fluid storage. In recent years, although the morbidity and mortality of cardiovascular diseases such as coronary heart disease, hypertension, valvular disease and the like are controlled, the incidence of heart failure is increasing. The global patients rapidly grow at the speed of 200 ten thousand per year, the prevalence rate of China is up to 1%, the death rate is equivalent to malignant tumors, and the five-year death rate is up to 50%, which causes great threat to human life health.

In recent years, modern medicine has made remarkable progress in the prevention and treatment of chronic heart failure, especially in the aspect of standardized treatment of medicines, and new therapeutic medicines are continuously produced. At present, four drugs, namely diuretics, angiotensin converting enzyme inhibitors, beta receptor blockers and cardiotonic drugs, are commonly used in clinic for treating heart failure. However, the treatment of some problems such as diuretic resistance, repeated hospitalization of heart failure, limited application of medicine due to side effects, reduced quality of life and the like in some stages, links or prevention and treatment of chronic heart failure are not ideal treatment measures, and are always difficulties and focuses in the field of heart failure research.

With the continuous development of traditional Chinese medicine industry, the research of treating chronic heart failure by traditional Chinese medicines is increasing, and the traditional Chinese medicines are beneficial to reducing adverse reactions while improving clinical symptoms. According to the clinical symptoms of chronic heart failure, the traditional Chinese medicine considers that the chronic heart failure is the syndrome of the principal deficiency and the secondary excess. Heart qi deficiency is the root cause of the pathogenesis, heart failure pathogenesis can be summarized by deficiency, blood stasis and water, and qi tonifying, blood circulation activating and water draining are the great therapeutic methods for heart failure. The traditional Chinese medicine has the therapeutic ideas of diagnosis and treatment and overall concept, and can regulate qi, blood and body fluid of a patient overall, improve symptoms, improve the disease resistance of the patient, reduce the repeated incidence times of heart failure patients due to various inducing factors, and have the advantages of less side effects, lasting curative effect, good compliance and the like.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating chronic heart failure, which is prepared from 10 raw medicinal materials including snakegourd fruit, dwarf lilyturf tuber, cassia twig, chinese angelica, platycodon root, szechuan lovage rhizome, indian buead, costustoot, liquoric root and Chinese magnoliavine fruit, has the effects of relieving chest stuffiness, eliminating phlegm, warming channels, dispelling cold, promoting qi circulation and relieving pain, is used for treating chronic heart failure, and provides a new choice for clinically treating chronic heart failure.

The invention relates to a traditional Chinese medicine composition for treating chronic heart failure, which is prepared from the following traditional Chinese medicine components:

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the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

in the recipe, the snakegourd fruit is sweet in taste, cold in nature, and capable of tonifying qi and resolving masses to relieve chest stuffiness, clear lung-heat and remove phlegm; ramulus Cinnamomi Wen Maitong, which is a monarch drug, is used for tonifying yang and restoring pulse. The Chinese angelica is used for replenishing blood and activating blood, the szechuan lovage rhizome is used for promoting qi and activating blood, and the costustoot is used for promoting qi and relieving pain, and the three components are combined, so that the Chinese angelica is used as ministerial drugs for promoting qi, regulating blood and relieving pain; radix Ophiopogonis has effects of nourishing yin, dredging collaterals, radix Platycodi has effects of dispersing lung qi, eliminating phlegm, and Poria has effects of invigorating spleen, promoting diuresis, and can be used as ministerial drug. The shizandra berry has warm nature, good shizandra berry property, astringes lung, calms heart and calms mind, and is an adjuvant drug. Licorice root, radix Glycyrrhizae Praeparata is a guiding drug for relieving pain and harmonizing the properties of drugs.

The medicines are combined, mutually assisted and complemented, complement each other, and have multiplied efficacy, and have the functions of relieving chest stuffiness, eliminating phlegm, warming channels, dispelling cold, promoting qi circulation and relieving pain. Mainly treats chronic heart failure, treats both principal and secondary aspect of disease and has multiple good effects.

The invention also aims to provide an oral preparation containing the traditional Chinese medicine composition and a preparation method thereof, wherein the traditional Chinese medicine oral preparation is one of oral liquid, mixture, tablet, granule, capsule and pellet.

The preparation method of the traditional Chinese medicine oral preparation comprises the following steps:

A. weighing 10 raw medicinal materials including snakegourd fruit, dwarf lilyturf tuber, cassia twig, chinese angelica, platycodon root, szechuan lovage rhizome, indian buead, costustoot, liquoric root and Chinese magnoliavine fruit, wherein the snakegourd fruit is cut into threads after being cleaned, the dwarf lilyturf tuber is flattened by double-roll pressing after being cleaned, the Indian buead and the Chinese magnoliavine fruit are coarsely crushed after being cleaned, the cassia twig is cut into segments after being cleaned, and the Chinese angelica, platycodon root, szechuan lovage rhizome, costustoot and liquoric root are cut into slices for standby.

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 6-10 times of water, decocting for 2 times and 2-3 hours each time, combining the decoctions, filtering, and concentrating under reduced pressure to obtain extract for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 60% -70%, standing, cold precipitating, filtering, recovering ethanol from the filtrate, and concentrating to obtain the extract for later use;

D. taking the extractum in the step C, adding pharmaceutically acceptable excipient according to the conventional process, and preparing into an oral pharmaceutical preparation.

Preferably, in the step B, the extract with the relative density of 1.11-1.17 is obtained by concentrating the extract under reduced pressure at 50-60 ℃.

Preferably, in the step C, the extract with the relative density of 1.24-1.29 is obtained by concentrating under reduced pressure at 50-60 ℃.

The conventional process described in step D includes, but is not limited to, water precipitation, filtration, concentration, spray drying, belt drying, pulverizing, sieving, and the like.

The acceptable excipient comprises one or more of filler, lubricant, preservative, flavoring agent, disintegrating agent, binder, colorant and dispersing agent.

Preferably, the pharmaceutically acceptable auxiliary materials include, but are not limited to, lactose, starch, dextrin, powdered sugar, magnesium stearate, maltose, lemon water, tartaric acid, sodium hydroxide, aspartame, stevioside, sodium cyclamate, proteoglycan, potassium acesulfame, aspartame, sucralose, sodium benzoate and the like.

In one embodiment, the oral preparation is an oral liquid, and the preparation method of the oral liquid comprises the following steps:

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 8 times of water for decoction for 3 hours for the first time, adding 6 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.14 at 50-60 ℃ for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 60 percent, standing and cold precipitating for 24 hours, filtering, recovering the ethanol from the filtrate, and concentrating the filtrate to obtain an extract with the relative density of 1.26 at 50-60 ℃ for later use;

D. adding 0.8% active carbon into the extract obtained in the step C, heating at 80 ℃, preserving heat, filtering, cold precipitating for 48h, adding a proper amount of sucrose or aspartame, stirring for dissolving, adjusting pH to be 7, adding water to the total amount, stirring, filtering, encapsulating and sterilizing to obtain the oral liquid.

In one embodiment, the oral formulation is a capsule, and the method of preparing the capsule comprises the steps of:

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 8 times of water for decoction for 2.5 hours for the first time, adding 6 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.11 at 50-60 ℃ for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 60 percent, standing and cold precipitating for 24 hours, filtering, recovering the ethanol from the filtrate, and concentrating the filtrate to obtain an extract with the relative density of 1.27 at 50-60 ℃ for later use;

D. and C, carrying out belt vacuum drying on the extractum in the step C under the conditions of vacuum degree of-0.08 MPa to 0.09MPa and 70 ℃, crushing into fine powder, sieving, adding starch and micro silica gel (weight ratio of 2:1) in the formula amount, uniformly mixing, granulating, drying, and filling capsules to obtain the capsule.

The third object of the invention is to provide the application of the traditional Chinese medicine composition in preparing medicines for treating chronic heart failure diseases.

In order to verify the efficacy of the traditional Chinese medicine composition for treating chronic heart failure, the inventor conducts a pharmacodynamic test. The medicine selected by the pharmacodynamic test of the invention is a representative formula of the invention and the medicine obtained by the preparation method thereof. The tests and results related to other formulations and to the pharmaceutical products obtained by the preparation method, which are encompassed by the present invention, are not exhaustive.

Experimental example 1 Effect on chronic heart failure rat model

1 Experimental materials

1.1 laboratory animals 70 SD rats of 6 week old male health SPF grade weighing 180-220g, provided by Lunan pharmaceutical group Co., ltd, laboratory animal eligibility number SYXK 2018-0008. Animals are fed in special laboratory cages, and are fed adaptively for 1 week before experiments, the room temperature is 20-25 ℃, the relative humidity is 40-60%, natural illumination is carried out, and free ingestion and drinking are carried out.

1.2 instruments, reagents and pharmaceutical Small desk-top centrifuges (Simer femto Co., USA), AG285 electronic analytical balance (Mettler-Toledo Co., switzerland), color Doppler ultrasound System (Michael medical treatment), ELISA kits (IL-1β, IL-10, TNF- α) (Sigma Co., USA), N-terminal brain natriuretic peptide precursor (NT-proBNP) kit (Shanghai enzyme-Linked Biotechnology Co., ltd.). The tested medicine is an oral liquid sample prepared according to the formula and the preparation method under the embodiment 3; the positive control drug was captopril tablet (specification: 0.25 mg/tablet, lot number: 191203), company, inc. of pharmaceutical factories, changzhou. Doxorubicin hydrochloride (specification: 10 mg/count, lot number: 02180901) for injection was obtained from Shanxiprad pharmaceutical Co., ltd.

2 Experimental methods

2.1 animal model preparation

The doxorubicin (doxorubicin hydrochloride) for injection is fully dissolved in 5ml of 0.9% sodium chloride injection, and then the total volume of the doxorubicin hydrochloride for injection is 25ml by adding the 0.9% sodium chloride injection, and the doxorubicin hydrochloride for injection is uniformly mixed to obtain the experimental liquid with the concentration of 0.4 mg/ml. The intraperitoneal injection is carried out according to the weight of the rat at a dose of 2mg/kg each time, 2 times per week for the first 2 weeks and 1 time per week for the last 6 weeks, and the total injection is 10 times continuously, and the cumulative dosage of the doxorubicin is 20mg/kg from 8 weeks. After 8 weeks, rats were weighed, anesthetized with 10% chloral hydrate by intraperitoneal injection, fixed on an operating table in a supine position, the forechest hair of the rats was shaved, the chest was exposed, left ventricular end systole inner diameters (LVIDs) and left ventricular end diastole inner diameters (LVIDd) were measured by M-ultrasound via cardiac color ultrasonography, the average value was taken over 3 cardiac cycles, and LVEF was calculated. The criterion for successful modeling was LVEF <60% and was determined in combination with the general condition of rats.

2.2 grouping administration 10 rats were taken as blank groups prior to modeling, and 50 rats successfully prepared by the model were randomly divided into 5 groups: model group, positive control group, test group (high dose, medium dose and low dose), 10 in each group. The clinical dosage of the tested medicine is 8.91g crude drug/kg, and the rats in the high, medium and low dosage groups are respectively administrated with 17.82g crude drug/kg, 8.91g crude drug/kg and 4.46g crude drug/kg for stomach irrigation every day, which are respectively equivalent to 2 times, equal time and 1/2 times of the clinical common dosage of human; the positive control group was given 2.25mg/kg captopril per day for gastric lavage, and rats in the blank group and the model group were given equal volumes of physiological saline for gastric lavage. Each group of rats was dosed continuously for 4 weeks.

2.3 detection index and method

(1) The survival status of the rats, such as feeding, water intake, body mass, respiration, activity, spirit, urination and defecation, fur, etc., was observed at regular daily intervals, and if the rats were dead, the dead rats were registered.

(2) After the last administration of the rats, the rats were anesthetized with 50mg/kg intraperitoneal injection of pentobarbital sodium, and were fixed on the supine position on the rat plates, from the lower left anterior chest collarbone to the lower rib margin. Doppler ultrasound is used for measuring the left heart structure and function of a rat through the chest wall, and the left ventricular contraction membrane diameter (LVESD), the Left Ventricular End Diastole Diameter (LVEDD), the Left Ventricular Ejection Fraction (LVEF) and the left ventricular inner diameter shortening rate (LVFS) are measured under the guidance of a left ventricular long-axis image to perform heart function analysis.

(3) The abdominal aorta of the rat is subjected to blunt separation, 8ml of blood is taken from the abdominal aorta, anticoagulation treatment is carried out, centrifugation is carried out for 10min at 4000r/min, serum is separated, and 3 parts of serum are obtained. The serum cytokines IL-1 beta (interleukin-1 beta), IL-10 (interleukin-10) and TNF-alpha (tumor necrosis factor-alpha) are measured by enzyme-linked immunosorbent assay (ELISA), and the level of NT-proBNP in the rat is measured by using an N-terminal brain natriuretic peptide precursor (NT-proBNP) kit.

(4) After the rat was sacrificed, heart and lung were removed, residual blood was sucked dry with filter paper, and the heart index and lung index were calculated by weighing.

2.4 statistical methods SPSS19.0 statistical software analysis was used. Experimental data are expressed as "mean ± standard deviation

"formal representation, the difference between groups was statistically significant using one-way analysis of variance with P < 0.05.

3 results of experiments

3.1 Effect on heart failure rat body Mass, heart and Lung

Throughout the experiment, no rats died. After modeling, rats in the blank group act agilely, the hair is shiny, and drinking water can be ingested normally. The other 5 model groups of rats had withered skin and skin, were lazy and crouched, had no desire to move, had reduced feeding, had shortness of breath, etc. After 4 weeks of administration, the hair and mental state of the rats in the positive control group and each test group are obviously improved compared with the model group, and the symptoms are obviously relieved.

Compared with the blank group, the heart index and the lung index of the rats in the model group are obviously increased (P < 0.05). The heart index and the lung index were significantly reduced (P < 0.05) for each test group compared to the model group. The results are shown in Table 1.

TABLE 1 influence of test drugs on rat body mass, heart and lung

n＝10)/>

Note that: compared to the blank: p < 0.05 is indicated by "; compared with the model group: p < 0.05' ^▲ "means.

3.2 comparison of cardiac function indicators of rats in each group

Compared with the blank group, the LVESD and LVEDD of the rats in the model group are obviously increased, LVEF and LVFS are obviously reduced, and the difference is statistically significant (P is less than 0.05). Compared with the model group, the positive control group and the rats in high, medium and low dose groups have significantly reduced LVESD and LVEDD, significantly increased LVEF and LVFS, and the difference has statistical significance (P < 0.05). The results are shown in Table 2.

TABLE 2 comparison of heart function indicators for rats of each group

n＝10)

3.3 comparison of inflammatory factor levels in groups of rats

Compared with the blank group, the cytokines IL-1 beta, IL-10 and TNF-alpha content in the serum of the rat in the model group are obviously increased, and the difference has statistical significance (P is less than 0.05). Compared with the model group, the positive control group and the high, medium and low dose groups of the test have the advantages that the content of the proinflammatory factors IL-1 beta and TNF-alpha in the serum of the rats is obviously reduced, the content of the anti-inflammatory factors IL-10 is obviously increased, and the difference has statistical significance (P is less than 0.05). The results are shown in Table 3.

TABLE 3 comparison of cytokine levels in groups of rats

n＝10)/>

3.4 comparison of serum NT-proBNP levels in groups of rats

NT-proBNP can reflect ventricular systolic and diastolic dysfunction, is secreted by the left ventricle mainly when the cardiac muscle receives an increase in pressure load, and is a recognized heart failure evaluation index. The test results show that the serum NT-proBNP level of the rats in the model group is increased compared with that in the blank group, the NT-proBNP level of the rats in the positive medicament group and each test group is obviously reduced (P is less than 0.05) compared with that in the model group, which indicates that the heart failure degree of the rats is relieved to different degrees after treatment, and the positive effect on the heart failure prognosis is achieved. The results are shown in Table 4.

TABLE 4 detection of NT-proBNP in rat serum of each group

n＝10)

The results show that the traditional Chinese medicine composition disclosed by the invention can reduce myocardial hypertrophy and pulmonary congestion caused by heart failure, effectively improve heart functions, improve ventricular remodeling and slow down inflammatory reaction processes, so that an exact treatment effect is exerted on chronic heart failure, and the treatment effect has dose dependency.

Detailed Description

In order for those skilled in the art to fully understand the present invention, the present invention is further illustrated by the following specific examples, but those skilled in the art should understand that the present invention is not limited in any way.

Example 1 preparation of granules

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 10 times of water for decoction for 3 hours for the first time, adding 8 times of water for decoction for 2.5 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.15 at 50-60 ℃ for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 70%, standing and cold precipitating for 24 hours, filtering, recovering ethanol from filtrate, and concentrating the filtrate to obtain extract with relative density of 1.25 at 50-60 ℃ for later use;

D. and C, carrying out belt vacuum drying on the extract in the step under the conditions of vacuum degree of-0.08 MPa to 0.09MPa and 70 ℃, crushing into fine powder, sieving, adding two times of mixed auxiliary materials (dextrin and lactose are mixed in a ratio of 1:1), adding 75% ethanol to prepare a soft material, sieving, granulating, drying and granulating to obtain granules.

Example 2 preparation of oral liquid

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 10 times of water for decoction for 2 hours for the first time, adding 8 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.17 at 50-60 ℃ for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 65%, standing and cold precipitating for 24 hours, filtering, recovering ethanol from filtrate, and concentrating the filtrate to obtain extract with relative density of 1.28 at 50-60 ℃ for later use;

D. adding 0.4% active carbon into the extract obtained in the step C, heating at 80 ℃, preserving heat, filtering, cooling and precipitating for 48h, adding a proper amount of sucrose or aspartame, stirring and dissolving, adjusting pH to be=6, adding water to the total amount, stirring, filtering, encapsulating and sterilizing to obtain the oral liquid.

Example 3 preparation of oral liquid

Example 4 preparation of tablets

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 9 times of water for decoction for 2.5 hours for the first time, adding 8 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.12 at 50-60 ℃ for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 70%, standing and cold precipitating for 24 hours, filtering, recovering ethanol from filtrate, and concentrating the filtrate to obtain extract with relative density of 1.29 at 50-60 ℃ for later use;

D. and C, carrying out belt vacuum drying on the extract in the step under the conditions of vacuum degree of-0.08 MPa to 0.09MPa and 70 ℃, crushing into fine powder, sieving, adding starch, dextrin and sucrose (weight ratio of 3:2:1) in the formula amount, uniformly mixing, granulating, drying, finishing, adding 0.3% magnesium stearate, uniformly mixing, and tabletting to obtain the tablet.

Example 5 preparation of capsules

Example 6 preparation of micropellets

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 8 times of water for decoction for 3 hours for the first time, adding 8 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.13 at 50-60 ℃ for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 65%, standing and cold precipitating for 24 hours, filtering, recovering ethanol from filtrate, and concentrating the filtrate to obtain extract with relative density of 1.27 at 50-60 ℃ for later use;

D. taking the extractum in the step C, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to 0.09MPa and 70 ℃, crushing into fine powder, sieving, adding microcrystalline cellulose, dextrin and starch, fully and uniformly mixing, adding ethanol solution with the concentration of 40% and the prescription amount of 52% (by weight) as a wetting agent, continuously kneading to prepare a soft material, and extruding the soft material into strips through a sieve plate with the aperture of 0.9mm of an extruder; turning on a rounding machine, selecting rotation speed of 1210rpm, placing the strip-shaped object into the rounding machine, rounding for 4min until the particles are rolled into pellets, taking out the pellets, drying at 41 ℃, and sieving to obtain 20-30 mesh pellets.

Example 7 preparation of capsules

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 9 times of water for decoction for 3 hours for the first time, adding 7 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.14 at 50-60 ℃ for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 70%, standing and cold precipitating for 24 hours, filtering, recovering ethanol from filtrate, and concentrating the filtrate to obtain extract with relative density of 1.24 at 50-60 ℃ for later use;

D. and C, carrying out belt vacuum drying on the extract in the step C at the vacuum degree of-0.08 MPa to 0.09MPa and at the temperature of 70 ℃, crushing into fine powder, sieving, adding sucrose powder, hydroxypropyl starch and mannitol (weight ratio of 4:2:1) in the formula amount, uniformly mixing, granulating, drying, finishing, filling, polishing in a polishing machine, and removing damaged capsules to obtain the capsule.

Example 8 preparation of granules

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 10 times of water for decoction for 2 hours for the first time, adding 6 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.15 at 50-60 ℃ for later use;

C. adding ethanol into the extract obtained in the step B to ensure that the ethanol content reaches 65%, standing and cold precipitating for 24 hours, filtering, recovering ethanol from filtrate, and concentrating the filtrate to obtain extract with relative density of 1.25 at 50-60 ℃ for later use;

D. and C, carrying out belt vacuum drying on the extractum in the step C under the conditions of vacuum degree of-0.08 MPa to 0.09MPa and 70 ℃, crushing into fine powder, sieving, adding dextrin in the formula amount for inclusion, adding sucrose serving as a flavoring agent, uniformly mixing, adding 90% ethanol to prepare a soft material, granulating, drying and finishing to obtain granules.

Example 9 preparation of granules

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 10 times of water for decoction for 3 hours for the first time, adding 8 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.14 at 50-60 ℃ for later use;

D. and C, carrying out belt vacuum drying on the extractum at the temperature of 70 ℃ under the vacuum degree of-0.08 MPa, crushing into fine powder, sieving, adding dextrin with the formula amount for inclusion, uniformly mixing, adding 85% ethanol to prepare a soft material, granulating, drying and finishing to obtain granules.

Example 10 preparation of tablets

B. Taking the crude drug decoction pieces in the step A, uniformly mixing, adding 9 times of water for decoction for 3 hours for the first time, adding 8 times of water for decoction for 2 hours for the second time, mixing decoctions, filtering, and reducing the filtrate to extract with relative density of 1.16 at 50-60 ℃ for later use;

D. and C, carrying out belt vacuum drying on the extract in the step under the condition of vacuum degree of-0.08 MPa and 70 ℃, crushing into fine powder, sieving, adding microcrystalline cellulose and sodium carboxymethyl starch (weight ratio of 3:1) in the formula amount, uniformly mixing, granulating, drying, granulating, adding 0.3% of magnesium stearate and 0.1% of talcum powder, uniformly mixing, and tabletting to obtain the tablet.

Claims

1. A Chinese medicinal composition is characterized by being prepared from the following Chinese medicinal components:

2. the traditional Chinese medicine composition according to claim 1, which is prepared from the following traditional Chinese medicine components:

3. the traditional Chinese medicine composition according to claim 2, which is prepared from the following traditional Chinese medicine components:

4. a Chinese medicinal oral preparation, comprising the Chinese medicinal composition according to any one of claims 1 to 3.

5. The oral traditional Chinese medicine preparation according to claim 4, wherein the oral traditional Chinese medicine preparation is one of oral liquid, mixture, tablet, granule, capsule and pellet.

6. The method for preparing the oral preparation of traditional Chinese medicine according to claim 5, which comprises the following steps:

7. The process according to claim 6, wherein the extract obtained in the step B is concentrated under reduced pressure to a relative density of 1.11 to 1.17 at 50 to 60 ℃.

8. The process according to claim 6, wherein the extract obtained in step C is concentrated under reduced pressure to a relative density of 1.24 to 1.29 at 50 to 60 ℃.

9. Use of a traditional Chinese medicine composition according to any one of claims 1-3 for the preparation of a medicament for the treatment of chronic heart failure.