CN113244308A - Pharmaceutical composition, preparation method, preparation and application thereof - Google Patents

Abstract

The invention discloses a pharmaceutical composition, a preparation method, a preparation and an application thereof, wherein the pharmaceutical composition comprises, by weight, 20-40 parts of rhodiola rosea, 30-60 parts of hairyvein agrimony, 5-20 parts of cassia twig, 5-20 parts of fried pepperweed seed, 20-30 parts of poria cocos, 10-20 parts of salvia miltiorrhiza and 5-20 parts of honey-fried licorice root. The prescription takes rhodiola as monarch drug, cassia twig, tuckahoe, semen lepidii and hairyvein agrimonia herb as ministerial drug, salvia miltiorrhiza as adjuvant drug and liquorice as conductant drug. The invention has scientific and reasonable compatibility and precise and appropriate compatibility, not only fully exerts the action advantages of each medicine, but also mobilizes the synergistic interaction between the medicines, and plays the roles of tonifying qi and warming yang, promoting blood circulation and removing obstruction in channels, promoting qi circulation and inducing diuresis together, thereby playing the roles of regulating and nourishing qi and blood, regulating and harmonizing qi activity and balancing yin and yang. The traditional Chinese medicine composition can expand coronary artery to increase blood flow of coronary artery, reduce oxygen consumption of cardiac muscle, improve energy metabolism of cardiac muscle by combining with modern pharmacological research, can effectively relieve clinical symptoms of patients with heart failure and improve cardiac function of patients, and clinical research proves that the total clinical effective rate of the traditional Chinese medicine composition reaches over 90 percent, and the traditional Chinese medicine composition is safe and has no toxic or side effect.

Description

Pharmaceutical composition, preparation method, preparation and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicine compositions and preparations, and particularly relates to a pharmaceutical composition for treating chronic heart failure, and a preparation method, a preparation and application thereof.

Background

Chronic Heart Failure (CHF) is a complex group of clinical syndromes caused by abnormal changes of cardiac structure and/or function due to various reasons, and dysfunction of ventricular contraction and/or diastolic function, and once clinical manifestations of Heart Failure appear in cardiovascular patients, poor prognosis is suggested, and the more Heart Failure, the higher death risk is suggested. According to foreign epidemiological statistics, the heart failure prevalence rate increases with the age of patients, the patients over 65 years old can reach 6% -10%, the cure rate is low, the prognosis is poor, about half of the patients die in five years, in Asia, the heart failure prevalence rate is more serious than that in Western countries, and the domestic latest survey result shows that the heart failure prevalence rate in China is about 1.3%, and about 440 ten thousand adult heart failure patients exist. It is seen that heart failure has become a global health burden. At present, the treatment of heart failure has been developed from traditional vasodilators, diuretics, cardiotonics and the like to the standard treatment scheme which takes beta-blockers, diuretics, angiotensin converting enzyme inhibitors as main drugs. With the intensive research on heart failure resistant drugs, more and more new heart failure resistant drugs are applied to clinical application, such as rhBNP, isotaxime and the like, but the factors such as high price, side effects of the drugs and the like are limited in clinical application, poor prognosis and high fatality rate of heart failure patients are still key and difficult points of clinical research, and the current situation of 'heavy treatment and light prevention' makes the prevention and treatment of heart failure diseases in China face a more and more severe situation. In the traditional Chinese medicine, the chronic heart failure does not have the disease name, the clinical symptoms can be classified into the categories of palpitation, severe palpitation, asthma syndrome, edema, heart water and the like, and the traditional Chinese medicine considers that the heart failure is in the heart, but the occurrence and development of the heart failure are closely related to the kidney, the lung, the spleen and the liver.

How to play the multi-target and multi-link coordination role of the traditional Chinese medicine on CHF, actively digging the advantages of the medicine sources of Yunnan nationality, searching and developing a pure traditional Chinese medicine preparation which can improve clinical symptoms and improve life quality and can perform early intervention aiming at main pathological mechanisms and promotion factors in the occurrence and development of heart failure, and being the hope of the vast traditional Chinese medicine workers and the prospect of preventing and treating heart failure of the traditional Chinese medicine.

Disclosure of Invention

The invention aims at providing a traditional Chinese medicine composition for treating chronic heart failure; further provides a preparation formulation of the traditional Chinese medicine composition and application thereof.

The first purpose of the invention is realized by that the Jinghe Yangxin Shu Chinese medicinal composition for treating chronic heart failure is composed of, by weight, 20-40 parts of rhodiola rosea, 30-60 parts of hairyvein agrimonia herb and bud, 5-20 parts of cassia twig, 5-20 parts of fried pepperweed seed, 20-30 parts of poria cocos, 10-20 parts of salvia miltiorrhiza and 5-20 parts of honey-fried licorice root.

The further purpose is realized by adding medically acceptable auxiliary materials into the traditional Chinese medicine composition prescription of the Jinghe Yangxinshu traditional Chinese medicine composition for treating the chronic heart failure, and preparing the medicine composition into any one of decoction, pills, tablets, capsules, paste, syrup, granules, powder and powder.

The Jinghe Yangxin Shu Chinese medicinal composition is applied to preparing a medicament for treating chronic heart failure or preparing a medicament for treating qi deficiency, blood stasis and water retention.

In traditional Chinese medicine, there is no name for chronic heart failure, and the clinical symptoms thereof can be classified into categories of palpitation, severe palpitation, asthma syndrome, edema, heart water and the like. The traditional Chinese medicine considers that the disease position of heart failure is in the heart, but the occurrence and development of the heart failure are closely related to the kidney, the lung, the spleen and the liver. The modern medicine proposes 'heart failure', which is a disease with the clinical characteristics of hypodynamia, palpitation, asthma and edema, is mostly generated in the later stage of the diseases such as palpitation, cardiodynia and the like, and is the final destination of various heart diseases. Clinically, heart failure is commonly seen in the elderly, and in "the sixties year, heart qi begins to fail" in "Ling Shu & Tian Nian (Ling Shu & Tian Nian)", … …; seventy years old, spleen deficiency, … …; eighty years old, failure of lung qi, … … "; "doctor lin correction" (for correction of errors): "No air is the deficiency, which must not reach the blood vessel, and the blood vessel is still without air and is stagnant. "the book of golden lack essence and water-qi diseases" the adverse blood condition refers to … … heart water, which is heavy and weak and cannot lie down, and it manifests the pathogenesis development law of qi deficiency, blood stasis and water retention of heart failure and the constitutional features of deficiency, so the qi deficiency in heart failure is the primary cause, and the metabolism of body fluid depends on the promotion of qi, and the long-term qi deficiency results in the generation of metabolic wastes such as blood stasis and water retention. Qi is the commander of blood and blood is the mother of qi, so qi and blood promote the reciprocal circulation. Qi deficiency causes blood stasis and water fluid gasification disorder, blood stasis causes water retention, blood stasis aggravates qi deficiency, water retention and internal stagnation further affects qi circulation and prevents qi circulation, and the three interact to form vicious circle of qi deficiency, blood stasis and water retention, which leads to continuous disease progression.

Therefore, the basic syndrome differentiation of this disease is qi deficiency, blood stasis and water retention. The basic treatment principle is 'tonifying qi, activating blood and promoting diuresis'. The inventor sends out a prescription based on the theory of dialectical demonstration of traditional Chinese medicine and combines years of clinical experience, local national medicine characteristics and the research foundation of modern medicine. The action mechanism of each medicinal ingredient in the basic formula of the invention is as follows:

rhodiola rosea (Rhodiolarolaseal) is a monarch drug for tonifying qi, relieving asthma, nourishing heart and dredging collaterals;

ramulus Cinnamomi warms and unblocks heart vessels, and helps yang and qi transformation, and Poria helps to enhance qi transformation of bladder, promote urination, and distribute water; semen Lepidii has effects of tonifying heart, purging lung and promoting diuresis, and can be used for relieving asthma, inducing diuresis and promoting diuresis to alleviate edema; the composition can be used together with qi-invigorating drugs to enhance qi-invigorating, superficial resistance-consolidating, and diuresis-promoting effects; the hairyvein agrimony is used for tonifying deficiency, has the effects of strengthening body resistance and tonifying deficiency, can slow down heart rate and relieve oxygen consumption of organisms while synergistically strengthening heart, and can enhance the qi tonifying effect of rhodiola rosea, and the four medicines are combined into ministerial medicines and synergistically play the effects of tonifying qi, warming yang, strengthening heart, inducing diuresis and relieving swelling;

the salvia miltiorrhiza is taken as an adjuvant drug, so that the effects of promoting blood circulation, removing blood stasis, relieving pain, calming heart and tranquilizing mind are exerted, and in addition, the coronary artery can be expanded, the coronary blood flow is increased, the myocardial ischemia is improved, and the myocardial hypoxia tolerance can be improved;

the 'Gulao' liquorice is taken as a guiding drug, can nourish heart vessels, harmonize the drugs, has the effects of invigorating spleen, tonifying qi, inducing diuresis, nourishing heart and tranquilizing mind by combining the effects of pungent and sweet taste of cassia twig, and yang of resolving, and tuckahoe, and has the effects of tonifying qi, warming yang, activating blood and inducing diuresis by combining the whole formula.

Rhodiola rosea is a wild rhodiola rosea in the Tibetan region of Shanshan in Shangrira of Chongqing, and the Tibetan is called as "Solomabao", which is called as "flame grass" or "eight-treasure grass". It is neutral in nature and sweet and bitter in flavor, entering lung and heart meridians. Has the effects of invigorating primordial qi, invigorating qi, promoting blood circulation, dredging collaterals, relieving asthma, nourishing brain, improving intelligence, nourishing and strengthening body, and is known as "plateau Ginseng radix". The record of the later-known "the rhodiola root, the origin of the root channel, eliminating evil and evil qi and tonifying deficiency" is rare in known tonifying drugs ", and the record of the modern practical materia medica" also says that it has the functions of anti-fatigue and strengthening heart. Modern pharmacological research finds that salidroside of the effective component plays an important role in myocardial protection, can inhibit the formation of lipid peroxide, enhance the capability of organism in clearing free radicals, simultaneously improve the activity of myocardial cells, resist oxidative stress reaction, protect ischemic and anoxic myocardial cells and inhibit the recombination and reconstruction of the myocardium.

The agrimony (agrimoniapirosa ledeb.) is the whole herb of Agrimonia pilosa Ledeb of perennial herb of Rosaceae, commonly known as delicacy and bitter and astringent in nature, and has an important function of strengthening body resistance and tonifying deficiency besides the function of astringency and hemostasis. The famous Chinese physicians practice Jinmo to think that the agrimony can strengthen the heart and stimulate the breathing. In recent years, further intensive research on the water extract of the hairyvein agrimony shows that the water extract has stronger heating and antioxidant active ingredients, and the effects of tonifying qi, resisting anoxia and protecting cardiac muscle cells are obviously enhanced by matching with the rhodiola rosea.

Poria, also known as Poria cocos, is produced in the genuine medicinal materials of Yunnan, is sweet and light in taste, has neutral nature, and has the effects of benefiting diuresis, excreting dampness, strengthening spleen and stomach, calming heart and tranquilizing; mainly treats difficult urination, edema and fullness, phlegm-fluid retention, coughing and vomiting, spleen deficiency and diarrhea, palpitation and uneasiness, insomnia and amnesia and the like, wherein tuckahoe is recorded in Shen nong herbal Jing to record that the chest and hypochondrium are adverse qi, knotted pain and the like, and Yunnan Hai Yu Heng Zhi: poria cocos is not pushed into Yunnan in the world, and is named as Poria cocos.

Salvia miltiorrhiza (SalviaminetirizhiaBge), which has been recognized for its blood circulation promoting and blood stasis removing effects, one of the lipid soluble components of Salvia miltiorrhiza is tanshinone IIA (Tan IIA), and its sulfonating agent tanshinone IIA sodium sulfonate (STS) has been widely used for clinical treatment of angina pectoris, cerebral apoplexy, tumor, hepatic fibrosis and other diseases. Tan IIA plays a role in resisting ventricular remodeling by improving myocardial hypertrophy, reducing myocardial apoptosis, inhibiting myocardial fibrosis, improving cardiac nerve remodeling, electrophysiological abnormality and other mechanisms. Tan IIA has better clinical application prospect on ventricular remodeling caused by various cardiovascular diseases.

Ting Li Zi (Drabanemonosa L.) was recorded in Shen nong Ben Cao Jing (Shen nong's herbal) and has pungent and bitter taste and cold nature. It enters lung and bladder meridians. Ting Li Zi has the actions of tonifying heart and purging lung-qi to remove water. In recent years, research results on cardiotonic pharmacological effects of the semen lepidii water extract show that the semen lepidii water extract can increase the left ventricular myocardial contractility and blood pumping function of dogs and increase coronary flow, and is similar to the effect of isoproterenol, but the semen lepidii water extract has no obvious influence on heart rate, artery and vein oxygen partial pressure and artery and vein oxygen solubility. The fact shows that the water extract of the pepperweed seed has the obvious effects of strengthening heart and increasing coronary flow, but does not increase myocardial oxygen consumption. The chloroform extract of semen Lepidii can increase myocardial contraction function, enhance ejection function, and increase blood output. The selection of the medicines is expected to play a role in the main pathological mechanisms and trigger factors of the pathological mechanisms in the occurrence and development of the chronic heart failure, such as myocardial energy metabolism disorder, ventricular remodeling and the like.

The Jinghe Yangxin Shu particle provided by the invention is used for treating chronic heart failure, can improve the traditional Chinese medicine symptoms and symptom integrals of patients with heart failure (qi deficiency, blood stasis and water retention syndrome), improves the cardiac function of the patients, improves the LVEF level, improves the life quality of the patients, and is expected to play a target role advantage in improving myocardial energy metabolism and inhibiting ventricular remodeling by combining with modern pharmacological research. The invention has the following characteristics:

1. the prescription is selected and used according to the basic pathogenesis that the heart failure disease has the pathological basis of qi deficiency, the key pathogenesis of blood stasis and the marked excess lesion of water retention, namely the qi deficiency, the blood stasis and the water retention.

2. The prescription is sent around the fundamental treatment principle of tonifying qi, activating blood and inducing diuresis. The heart and lung are mainly deficient in qi (yang), while the excess is blood stasis and water retention. The heart diseases can involve lung, spleen and kidney, the interaction of qi, blood and water is the disease, and the malignant circulation is blocked by benefiting qi, activating blood circulation and inducing diuresis, thus finally achieving the purpose of treatment.

3. The prescription is sent to the user according to the concept of combining Chinese and western medicine theories: the prescription is used by combining the traditional Chinese medicine pathogenesis of heart failure such as qi deficiency, blood stasis and water retention with the pathological mechanism of ventricular remodeling in modern medicine. The medicine has the effects of regulating energy metabolism, improving myocardial blood supply, reducing myocardial damage, inhibiting inflammatory reaction, resisting apoptosis and blocking ventricular remodeling by benefiting qi, activating blood circulation and inducing diuresis, and can effectively play a target treatment role in treating chronic heart failure.

4. The concept of 'preventing diseases before the disease is treated, preventing the disease from being prevented, and preventing recovery after the patient is healed' in the traditional Chinese medicine is adopted throughout the whole time, and the disease prevention is performed before the disease is treated. The medicine has the functions of regulating qi and blood, regulating qi activity, balancing yin and yang, and inhibiting the development of disease course.

5. The formula of the invention has precise and appropriate compatibility, scientific and reasonable compatibility, natural drug properties, complementary and complement each other. The whole formula has the effects of strengthening qi, promoting blood circulation and promoting diuresis, and is directly used for three pathological factors of qi deficiency, blood stasis and water retention of chronic heart failure; can effectively relieve the clinical symptoms of patients with heart failure, improve the cardiac function of the patients and improve the life quality, and the preliminary clinical research proves that the total clinical effective rate of the traditional Chinese medicine preparation reaches over 90 percent and the traditional Chinese medicine preparation has no toxic or side effect.

6. The single medicine in the formula is characterized in that a formula thought with the characteristic of Yunnan national medicine as a main part is selected, and the development and utilization of the characteristic national medicine resources are facilitated.

Drawings

FIG. 1 is a flow chart of a process for preparing granules of the present invention;

fig. 2 is a flow chart of the preparation process of the pill of the invention.

Detailed Description

The invention is further illustrated by the following examples, but is not to be construed as being limited in any way, any modifications made in accordance with the teachings of the present invention being within the scope thereof.

The invention relates to a pharmaceutical composition which is characterized by comprising, by weight, 20-40 parts of rhodiola rosea, 30-60 parts of hairyvein agrimony, 5-20 parts of cassia twig, 5-20 parts of fried pepperweed seed, 20-30 parts of poria cocos, 10-20 parts of salvia miltiorrhiza and 5-20 parts of honey-fried licorice root.

The traditional Chinese medicine composition also comprises 15-30 parts of prepared monkshood and 10-15 parts of dried ginger.

The method comprises the following steps: the prepared monkshood plays a role of 'tonifying fire and supporting yang', and helps the cassia twig to warm and dredge heart and kidney, and shows that the heart and kidney are treated simultaneously; gan Jiang can warm spleen yang and dispel cold to resolve retained fluid. "has relative therapeutic action on central nerve, cardiovascular system and digestive system. The dried ginger also has the effects of resisting inflammation, resisting anoxia, promoting urination and the like.

The traditional Chinese medicine composition also comprises 10-15 parts of dried ginger, 3-6 parts of asarum and 10-15 parts of schisandra chinensis.

The method comprises the following steps: the dried ginger has the effects of warming spleen yang, dispelling cold and resolving fluid retention, and the asarum is pungent, fragrant and fleeing in nature, can reach the vertex, is beneficial to nine orifices, has the effect of warming lung and resolving fluid retention, and is mainly used for treating cold-retained cough and asthma. Schisandra chinensis is sour and astringent in nature, astringes lung qi, receives kidney qi, calms heart qi, and is mainly used for treating deficiency asthma and palpitation. The three components are usually combined to achieve the effect of warming yang and resolving fluid retention.

The traditional Chinese medicine composition also comprises 15-20 parts of radix stephaniae tetrandrae, 30-80 parts of astragalus membranaceus and 15-30 parts of radix stephaniae tetrandrae.

The method comprises the following steps: fang Ji is bitter, pungent and cold in property, entering bladder and lung meridians. It is good at inducing diuresis and alleviating edema, and good at moving downward and draining bladder water, especially suitable for edema of lower limbs and dysuria. It also has blood pressure lowering effect. Astragalus root is the essential drug for invigorating qi, and has the effects of invigorating qi, consolidating superficial resistance, inducing diuresis, and invigorating qi and promoting diuresis. The bighead atractylodes rhizome has the functions of tonifying spleen and qi, eliminating dampness and inducing diuresis, and hilling up to produce water.

The medicinal preparation of the medicinal composition is prepared by adding medically acceptable auxiliary materials into the formula of the Chinese medicinal composition and preparing the mixture into any one of decoction, pills, tablets, capsules, paste, syrup, granules, powder and powder.

The preparation method of the granules comprises the following steps:

(1) decocting: the weight ratio of the medicinal materials except the cassia twig in the prescription is 1: 6-1: 12 adding water and decocting for 1-3 times, each time for 30-90 min, and combining the decoction;

(2) concentration: concentrating the obtained decoction into thick paste at the temperature of 55-75 ℃ and the vacuum degree of-0.02-0.06 MPa, wherein the density of the thick paste is 1.20-1.35 g/ml at the temperature of 50-60 ℃;

(3) and (3) drying: drying the thick paste at 65-75 ℃ and under the vacuum degree of-0.02-0.06 MPa to obtain dry paste, crushing and sieving by a 100-mesh sieve to obtain dry paste powder for later use;

(4) weighing cassia twig according to the weight parts in the formula, mixing the cassia twig with the dry paste powder, adding 20-40 g of granulation auxiliary materials, uniformly mixing, adding a proper amount of 60-95% ethanol, carrying out wet granulation, and drying to obtain the granules.

The granulating auxiliary material is one or the combination of more than one of dextrin, maltodextrin or sucrose.

The preparation method of the pharmaceutical composition comprises the following steps:

(1) decocting: weighing rhodiola rosea, cassia twig, poria cocos and salvia miltiorrhiza in the formula according to parts by weight, crushing into fine powder, and sieving with a 100-mesh sieve for later use; the other medicinal materials are weighed according to the formula amount, and the weight ratio of the medicinal water is 1: 6-1: 12 adding water and decocting for 1-3 times, each time for 30-90 min, and combining the decoction;

(2) concentration: concentrating the obtained decoction into thick paste at the temperature of 55-75 ℃ and the vacuum degree of-0.02-0.06 MPa, wherein the density of the thick paste is 1.20-1.35 g/ml at the temperature of 50-60 ℃;

(3) and (3) drying: drying the thick paste at 65-75 ℃ and under the vacuum degree of-0.02-0.06 MPa to obtain dry paste, crushing and sieving by a 100-mesh sieve to obtain dry paste powder for later use;

(4) mixing the pulverized fine powder with the dry extract powder, and making into pill with water or 30% or less ethanol.

The Jinghe Yangxin Shu Chinese medicinal composition is applied to preparing a medicament for treating chronic heart failure.

The Jinghe Yangxin Shu Chinese medicinal composition is applied to the preparation of the medicament for treating qi deficiency, blood stasis and water retention.

The prescription preparation of the invention, besides the existing granules, is preferably pills for the following reasons: in the formula, the cassia twig contains volatile oil, and the volatile oil is extracted separately or crushed to avoid the loss of the volatile oil in the processes of decoction and concentration. The drug effect is better exerted.

Example 1

30g of rhodiola rosea, 55g of hairyvein agrimony, 15g of fried semen lepidii, 30g of poria from Yunnan of China, 15g of salvia miltiorrhiza and 10g of honey-fried licorice root are taken, water is added for decoction for 2 times, each time is 60min, and the weight ratio of the raw materials to the water is 1: 10. concentrating the decoction at 65 deg.C under-0.05 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 70 deg.C under-0.02 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 10g, adding the above dry extract powder, adding dextrin 30g, mixing, adding 75% ethanol, and granulating.

Example 2

Taking 20g of rhodiola rosea, 30g of hairyvein agrimony, 10g of fried semen lepidii, 20g of poria from Yunnan of China, 10g of salvia miltiorrhiza and 5g of honey-fried licorice root, adding water, decocting for 3 times, each time for 45min, wherein the weight ratio of the raw materials to the water is 1: 10. concentrating the decoction at 70 deg.C under-0.03 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 70 deg.C under-0.03 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 5g, adding the above dry extract powder, adding 40g sugar powder, mixing, adding 65% ethanol, and granulating.

Example 3

Taking 40g of rhodiola rosea, 60g of hairyvein agrimony, 15g of fried semen lepidii, 25g of poria from Yunnan of China, 15g of salvia miltiorrhiza and 15g of honey-fried licorice root, adding water, decocting for 1 time and 90min each time, wherein the weight ratio of the raw materials to the water is 1: 12. concentrating the decoction at 55 deg.C under-0.06 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 65 deg.C under-0.03 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 15g, adding the above dry extract powder, adding dextrin 20g, mixing, adding 90% ethanol, and granulating.

Example 4

Taking 25g of rhodiola rosea, 50g of hairyvein agrimony, 15g of fried semen lepidii, 30g of poria from Yunnan of China, 15g of salvia miltiorrhiza, 10g of honey-fried licorice root, 15g of prepared monkshood and 10g of dried ginger, firstly decocting the prepared monkshood for 1h, then adding other medicinal ingredients, adding water for decocting for 2 times, 60min each time, wherein the weight ratio of the raw materials to the water is 1: 8. concentrating the decoction at 65 deg.C under-0.03 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 70 deg.C under-0.05 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 20g, adding the above dry extract powder, adding dextrin 30g, mixing, adding 75% ethanol, and granulating.

Example 5

Taking 35g of rhodiola rosea, 55g of hairyvein agrimony, 15g of fried semen lepidii, 25g of poria from Yunnan of China, 15g of salvia miltiorrhiza, 15g of honey-fried licorice root, 30g of prepared aconite root and 15g of dried ginger, firstly decocting the prepared aconite root for 1h, then adding other medicinal ingredients, adding water for decocting for 3 times, 30min each time, wherein the weight ratio of the raw materials to the water is 1: 8. concentrating the decoction at 75 deg.C under-0.02 MPa to obtain soft extract with density of 1.35g/ml at 50 deg.C. Drying the above soft extract at 70 deg.C under-0.03 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 5g, adding the above dry extract powder, adding 40g sugar powder, mixing, adding 65% ethanol, and granulating.

Example 6

40g of rhodiola rosea, 60g of hairyvein agrimony, 20g of fried semen lepidii, 30g of poria from Yunnan of China, 20g of salvia miltiorrhiza, 20g of honey-fried licorice root, 15g of dried ginger, 6g of asarum and 15g of schisandra chinensis are taken. Decocting in water for 45min for 3 times, wherein the weight ratio of the raw materials to water is 1: 8. concentrating the decoction at 75 deg.C under-0.02 MPa to obtain soft extract with density of 1.20g/ml at 50 deg.C. Drying the above soft extract at 75 deg.C under-0.03 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 20g, adding the above dry extract powder, adding dextrin 40g, mixing, adding 65% ethanol, and granulating.

Example 7

20g of rhodiola rosea, 30g of hairyvein agrimony, 5g of fried semen lepidii, 20g of poria from Yunnan of China, 10g of salvia miltiorrhiza, 5g of honey-fried licorice root, 10g of dried ginger, 3g of asarum and 10g of schisandra chinensis are taken. Decocting in water for 1 time, each time for 90min, wherein the weight ratio of the raw materials to water is 1: 10. concentrating the decoction at 55 deg.C under-0.06 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 65 deg.C under-0.05 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 5g, adding the above dry extract powder, adding dextrin 40g, mixing, adding 65% ethanol, and granulating.

Example 8

25g of rhodiola rosea, 35g of hairyvein agrimony, 10g of fried semen lepidii, 25g of poria from Yunnan of China, 15g of salvia miltiorrhiza, 10g of honey-fried licorice root, 15g of radix stephaniae tetrandrae, 30g of astragalus mongholicus and 15g of bighead atractylodes rhizome. Decocting in water for 2 times, each for 40min, wherein the weight ratio of the raw materials to water is 1: 6. concentrating the decoction at 60 deg.C under-0.04 MPa to obtain soft extract with density of 1.25g/ml at 55 deg.C. Drying the above soft extract at 65 deg.C under-0.05 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 10g, adding the above dry extract powder, adding dextrin 20g, mixing, adding 65% ethanol, and granulating.

Example 9

Taking 35g of rhodiola rosea, 50g of hairyvein agrimony, 15g of fried semen lepidii, 25g of poria from Yunnan of China, 15g of salvia miltiorrhiza, 15g of honey-fried licorice root, 20g of radix stephaniae tetrandrae, 80g of astragalus and 30g of bighead atractylodes rhizome. Decocting in water for 2 times, each time for 60min, wherein the weight ratio of the raw materials to water is 1: 8. concentrating the decoction at 65 deg.C under-0.05 MPa to obtain soft extract with density of 1.35g/ml at 55 deg.C. Drying the above soft extract at 70 deg.C under-0.04 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Pulverizing ramulus Cinnamomi 15g, adding the above dry extract powder, adding dextrin 30g, mixing, adding 65% ethanol, and granulating.

Example 10

30g of rhodiola rosea, 10g of cassia twig, 30g of poria cocos and 5g of salvia miltiorrhiza are taken, crushed into fine powder and sieved by a 100-mesh sieve for later use. Taking 50g of hairyvein agrimony, 15g of fried pepperweed seed and 10g of honey-fried licorice root, adding water, decocting for 2 times, 60min each time, wherein the weight ratio of the raw materials to the water is 1: 10. concentrating the decoction at 65 deg.C under-0.04 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 70 deg.C under-0.04 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with 10% ethanol.

Example 11

Pulverizing radix Rhodiolae 20g, ramulus Cinnamomi 5g, Poria 20g, and Saviae Miltiorrhizae radix 10g into fine powder, and sieving with 100 mesh sieve. Taking 40g of hairyvein agrimony, 10g of fried pepperweed seed and 5g of honey-fried licorice root, adding water, decocting for 3 times, 45min each time, wherein the weight ratio of the raw materials to the water is 1: 10. concentrating the decoction at 70 deg.C under-0.06 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 70 deg.C under-0.06 MPa vacuum to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with water.

Example 12

Pulverizing 40g of rhodiola rosea, 15g of cassia twig, 25g of poria cocos and 15g of salvia miltiorrhiza into fine powder, and sieving the fine powder with a 100-mesh sieve for later use. Taking 55g of hairyvein agrimony, 15g of fried pepperweed seed and 15g of honey-fried licorice root, adding water, decocting for 1 time and 90min each time, wherein the weight ratio of the raw materials to the water is 1: 12. concentrating the decoction at 65 deg.C under-0.05 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 75 deg.C under-0.05 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with water.

Example 13

Pulverizing 25g of rhodiola rosea, 5g of cassia twig, 25g of poria cocos and 10g of salvia miltiorrhiza into fine powder, and sieving the fine powder with a 100-mesh sieve for later use. Taking 40g of hairyvein agrimony, 5g of fried pepperweed seed, 5g of honey-fried licorice root, 15g of prepared monkshood and 10g of dried ginger; decocting radix Aconiti lateralis Preparata for 1h, adding water 8 times of herba et Gemma Agrimoniae, parched semen Lepidii, and radix Glycyrrhizae Preparata, decocting for 2 times, each time for 60min, and concentrating the decoction at 65 deg.C under-0.03 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 70 deg.C under-0.03 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with 10% ethanol.

Example 14

Pulverizing 35g of rhodiola rosea, 10g of cassia twig, 25g of poria cocos and 10g of salvia miltiorrhiza into fine powder, and sieving the fine powder with a 100-mesh sieve for later use. Taking 35g of hairyvein agrimony, 10g of fried pepperweed seed, 15g of honey-fried licorice root, 30g of prepared monkshood and 15g of dried ginger; decocting radix Aconiti lateralis Preparata for 1h, adding herba et Gemma Agrimoniae, parched semen Lepidii, and radix Glycyrrhizae Preparata with 6 times of water, decocting for 70min for 2 times, and concentrating the decoction at 60 deg.C under-0.02 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 65 deg.C under-0.02 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with 10% ethanol.

Example 15

Pulverizing 35g of rhodiola rosea, 20g of cassia twig, 30g of poria cocos and 20g of salvia miltiorrhiza into fine powder, and sieving the fine powder with a 100-mesh sieve for later use. Taking 60g of hairyvein agrimony, 20g of fried pepperweed seed, 20g of honey-fried licorice root, 10g of dried ginger, 3g of asarum and 10g of Chinese magnoliavine fruit, adding water, decocting for 3 times, 30min each time, wherein the weight ratio of the raw materials to the water is 1: 12. concentrating the decoction at 55 deg.C under-0.03 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 55 deg.C under-0.06 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with water.

Example 16

30g of rhodiola rosea, 20g of cassia twig, 20g of poria cocos and 10g of salvia miltiorrhiza are taken, crushed into fine powder and sieved by a 100-mesh sieve for later use. 30g of hairyvein agrimony, 10g of fried pepperweed seed, 10g of honey-fried licorice root, 15g of dried ginger, 6g of asarum and 15g of Chinese magnoliavine fruit are taken and decocted with water for 1 time, each time is 90min, and the weight ratio of the raw materials to the water is 1: 10. concentrating the decoction at 65 deg.C under-0.05 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 65 deg.C under-0.03 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with water.

Example 17

40g of rhodiola rosea, 20g of cassia twig, 30g of poria cocos and 15g of salvia miltiorrhiza are taken, crushed into fine powder and sieved by a 100-mesh sieve for later use. Taking 45g of hairyvein agrimony, 15g of fried pepperweed seed, 20g of honey-fried licorice root, 15g of radix stephaniae tetrandrae, 30g of astragalus and 15g of bighead atractylodes rhizome, decocting for 2 times, and concentrating the obtained decoction into thick paste at the temperature of 55 ℃ and the vacuum degree of-0.05 MPa, wherein the density of the thick paste at the temperature of 50 ℃ is 1.25 g/ml. Drying the above soft extract at 75 deg.C under-0.02 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with 10% ethanol.

Example 18

Pulverizing radix Rhodiolae 20g, ramulus Cinnamomi 10g, Poria 20g, and Saviae Miltiorrhizae radix 10g into fine powder, and sieving with 100 mesh sieve. Taking 30g of hairyvein agrimony, 5g of fried pepperweed seed, 5g of honey-fried licorice root, 20g of radix stephaniae tetrandrae, 80g of astragalus and 30g of bighead atractylodes rhizome, adding water, decocting for 1 time and 80min each time, wherein the weight ratio of the raw materials to the water is 1: 8. concentrating the decoction at 55 deg.C under-0.06 MPa to obtain soft extract with density of 1.25g/ml at 50 deg.C. Drying the above soft extract at 75 deg.C under-0.02 MPa to obtain dry extract, and pulverizing to obtain 100 mesh dry extract powder. Adding the above fine powders, mixing, and making into pill with water.

Examples of the experiments

The Jinghe Yangxin Shu for treating qi deficiency, blood stasis and water retention of chronic heart failure with the formula of the invention proves that the experimental results are as follows:

1. data and method

1.1 clinical data

72 patients with chronic heart failure are confirmed by clinical diagnosis of cardiovascular disease departments and specialist outpatients of traditional Chinese medicine hospitals in Kunming city from 2017 to 2020 and 1 month. 10 cases are eliminated, 1 case is removed, and 61 cases are effective cases finally, wherein 31 cases in a treatment group comprise 24 men and 7 women, the age is (73.13 +/-5.24), and the course of disease is 5-14 years; 30 control groups, 21 male groups and 9 female groups, wherein the age (72.10 +/-8.54) is 4-12 years; the difference between the two groups of patients in the aspects of sex constitution, age, disease course, cardiac function grading, etc. has no statistical significance (P is more than 0.05), and has comparability.

1.2 diagnostic criteria

1.2.1 Western diagnostic criteria: refer to the Chinese Heart failure diagnosis and treatment guideline 2018, which is defined by the China medical society, the cardiovascular disease society, and the China journal editorial Committee.

1.2.2 Chinese medicine diagnosis standard: according to 2002 edition of guiding principles of clinical research on new traditional Chinese medicines [3], a syndrome differentiation standard of qi deficiency, blood stasis and water retention is formulated; the main symptoms are: asthma, weakness, edema, palpitation, chest distress or chest pain; the secondary symptoms are as follows: spontaneous sweating, abdominal distension, poor appetite, scanty urine, and poor sleep; tongue pulse: dark purple tongue with petechia and ecchymosis, and unsmooth or weak pulse; has 4 main symptoms and 2 secondary symptoms, and can be diagnosed by combining tongue pulse conditions.

1.3 inclusion criteria

1.3.1 compliance with the diagnostic criteria for chronic heart failure;

1.3.2 cardiac function ratings reference the New York Heart Association cardiac function ratings Standard;

1.3.3 meets the standard of qi deficiency, blood stasis and water retention syndrome of heart failure;

1.3.4 sign an informed consent.

1.4 exclusion criteria

Acute myocardial infarction, gestation period, malignant tumor, dementia or mental disorder, and severe liver and kidney dysfunction.

1.5 methods of treatment

Control group: administration of conventional treatment for chronic heart failure: comprises ACEI or ARB, beta receptor blocker, aldosterone antagonist, diuretic, CCB, nitrate drugs, antiplatelet drugs, lipid regulating drugs, hypoglycemic drugs, etc., and the treatment course is 30 days.

Treatment groups: on the basis of standard treatment of western medicine, Jing He Yan Xin Shu granules (30 g of rhodiola rosea, 10g of cassia twig, 15g of fried semen lepidii, 30g of Yunnan tuckahoe, 50g of hairyvein agrimony, 15g of salvia miltiorrhiza and 10g of honey-fried licorice root) are added and uniformly prepared by the Kanrinseng pharmaceutical industry, 1 bag is taken for 1 time, 3 times a day and 150ml of warm boiled water is taken with 30 days of treatment course.

1.6 Observation index

1.6.1 traditional Chinese medicine syndrome and symptom integral evaluation: the symptoms of the traditional Chinese medicine are evaluated according to a symptom grading quantization table in the clinical research guiding principle of the new traditional Chinese medicine, asthma, hypodynamia, edema, palpitation, chest distress or chest pain; spontaneous sweating, abdominal distention, anorexia, oliguria and poor sleep totaling 10 symptoms, which are classified into no, light, medium and heavy 4 grades and assigned to 0, 1, 2 and 3 points respectively.

1.6.2 cardiac functional grading: reference is made to the new york heart association heart function classification standard division.

1.7 safety index

Before and after treatment, liver and kidney functions and electrocardiogram are detected. The time of occurrence, clinical symptoms, duration, treatment and disappearance of adverse reactions were recorded in detail.

1.8 therapeutic efficacy evaluation criteria

1.8.1 refer to the standard for determining the curative effect of the syndrome in traditional Chinese medicine in the guideline for clinical research of new Chinese medicines. The effect is shown: the primary symptoms and the secondary symptoms basically or completely disappear, and the integral of the symptoms after treatment is 0 point or 70 percent less; the method has the following advantages: the syndrome score after treatment is reduced by more than or equal to 30 percent and less than 70 percent; and (4) invalidation: the reduction of the syndrome score after treatment is less than 30%; weighting: the post-treatment syndrome score exceeds the pre-treatment score.

1.8.2 the standard of the grading curative effect judgment of cardiac function, significant effect: heart failure is completely controlled or cardiac function is improved by more than 2 levels; the method has the following advantages: most of the symptoms and physical signs of the heart failure disappear or are relieved, and the heart function is improved by more than grade 1; and (4) invalidation: after 1 treatment course, the symptoms are not improved, and the cardiac function is not changed.

1.9 statistical analysis

And (4) sorting and summarizing all data, importing the data into excel software to establish a database, and performing statistical processing by adopting an SPSS24.0 statistical software package. The counting data were examined with X2. The measurement data conforming to the normal distribution is described by means of t test and mean plus or minus standard deviation (X plus or minus S); the nonparametric inspection of the persons who accord with the skewness distribution is described by using a median and a quartile. The statistical result takes P more than 0.05 as non-statistical significance, and takes P less than 0.05 and P less than 0.01 as statistical significance.

2. Results

2.1 the total effective rates of the two groups of traditional Chinese medicine are compared (see Table 1)

Two groups of traditional Chinese medicine total effective rate comparison n (%) (Table 1)

Note: the total effective rates of the two groups are compared, and P is less than 0.05, which indicates that the treatment group is superior to the control group in improving the clinical symptoms of patients and the traditional Chinese medicine syndrome integral.

2.2 comparison of the two groups of improvement in cardiac function (see Table 2)

Note: p is less than 0.05 compared with the group before treatment; compared with the control group after treatment, P is less than 0.05, which indicates that the treatment group has better curative effect on improving the cardiac function of the patient than the control group.

Discussion of the invention

Chronic heart failure is a complex group of clinical syndromes, and once a cardiovascular patient has clinical manifestations of heart failure, the prognosis is poor, and the heavier the heart failure, the higher the death risk. Recent survey results in China show that the heart failure prevalence rate in China is about 1.3%, and about 440 ten thousand adult heart failure patients exist [4 ]. It is seen that heart failure has become a global health burden. At present, the treatment of heart failure has been developed from traditional vasodilators, diuretics and cardiotonics to the standard treatment scheme which takes beta-blockers, diuretics and angiotensin converting enzyme inhibitors as main drugs. With the research of heart failure resisting drugs, more and more new heart failure resisting drugs are applied clinically, such as rhBNP, isotaxime and the like, but the clinical application of the factors such as high price, side effects of the drugs and the like is limited, and the current situations of poor prognosis and high fatality rate of heart failure patients are still the key points and difficulties of the research. Clinical practice proves that the inventor takes physiotherapy of traditional Chinese medicine as a basis, comprehensively distinguishes symptoms, utilizes rhodiola rosea which is a natural medicine with unique pharmacological action as a monarch medicine, and elaborately sends out medicine formula Jinghe Yangxin Shu granule (pill) has good clinical treatment effect on chronic heart failure, especially heart failure caused by qi deficiency, blood stasis and water retention syndrome. Treat both manifestation and root cause of disease, and has lasting effect and good prognosis effect. The effect of the present invention will be further described below by taking several representative cases.

Typical case 1:

patient XX, female, 65 years old, yunnan kunming. The patient can be diagnosed in 2019 in 3 months after the patient is aggravated with swollen limbs due to repeated chest distress and wheezing for more than 4 years. The patient repeatedly suffers from chest distress and shortness of breath after fatigue in the last 4 years, aggravates after physical activity, is accompanied by intermittent edema of both lower limbs, and has paroxysmal dyspnea, abdominal distention, dizziness, cough occasionally, and white sticky phlegm. The disease condition is still stable when the medicine is intermittently taken, such as spironolactone, irbesartan hydrochlorothiazide, metoprolol and the like, which are diagnosed as hypertensive heart disease, chronic cardiac insufficiency and the like in an outpatient department. In nearly 1 month, mild physical activity can cause chest distress, palpitation, shortness of breath, asthma, dizziness, edema of the ankle of both lower limbs in the afternoon, and pain and discomfort in the hypochondriac area, the lumbar area and the back.

The initial diagnosis is as follows: clear mind, poor eyesight, pale complexion, normal morphology, free gait and deep and low voice. Chest distress, palpitation, dyspnea with shortness of breath, especially after exercise, dizziness, hypochondriac pain, low back pain, mental fatigue, lassitude, and slight concave edema of the shin and ankle of both lower limbs. Pale and dark with swollen tongue with teeth marks on the tongue edge, petechia under tongue, thin and white coating and deep and weak pulse; second, it is easy to sleep late and less.

The traditional Chinese medicine diagnoses the syndrome of heart water disease, qi deficiency, blood stasis and water retention. The basic therapeutic principle of 'tonifying qi, activating blood circulation, promoting diuresis, warming lung and dispelling cold' is determined by comprehensive syndrome differentiation.

Preparing a formula: jinghe Yangxin Shu granule, the specific prescription is: 30g of rhodiola rosea, 40g of hairyvein agrimony, 10g of cassia twig, 15g of fried pepperweed seed, 30g of poria from Yunnan of China, 20g of salvia miltiorrhiza and 10g of honey-fried licorice root. The preparation method of the invention prepares the formula into granules. The medicine is taken 1 bag/time, 3 times/time and 1 hour after meal. The treatment is carried out for a second visit after 1 week.

And B, diagnosis: the symptoms of palpitation, chest distress and short breath of patients are relieved, edema and hypofunction of both lower limbs are reduced, the tongue is pale and dark, the tooth marks on the side of the tongue are reduced, the tongue is petechia, the tongue coating is thin and white, and the pulse is deep and weak. The original prescription is taken for 10 days for further treatment.

Three diagnoses: after the patient moves, the patient has no obvious symptoms of palpitation, chest distress and short breath, and has no obvious edema of both lower limbs, and the Jinghe heart nourishing and original soothing formula is used for 10 days. Patients are revisited after half a month, the appetitive state is good, the state of the illness is stable, the activities are free, and the asthma does not relapse.

Clinical medical record 2

Patients with certain leaf and female age of 63 years are treated with the disease of 'repeating chest distress and wheezing for more than 2 years, aggravating with limb swelling and cold limbs for 1 week'. The initial diagnosis is as follows: chest distress, dyspnea with shortness of breath, palpitation, hypodynamia, edema of both lower limbs with cold hands and feet, loose stool and poor sleep. Pale and dark tongue with teeth marks on the tongue edge, sublingual ecchymosis, thin and white coating, and deep and weak pulse.

The traditional Chinese medicine diagnoses the heart water disease, and the syndrome of qi deficiency, blood stasis and water retention accompanied with yang deficiency. The basic therapeutic principle of 'tonifying qi, warming yang, promoting blood circulation and inducing diuresis' is determined by comprehensive syndrome differentiation.

Preparing a formula: the Jinghe Yangxin Shu granule is added with flavor, and the specific prescription is as follows: 20g of rhodiola rosea, 40g of hairyvein agrimony, 15g of cassia twig, 15g of fried pepperweed seed, 20g of poria, 15g of salvia miltiorrhiza, 15g of prepared monkshood, 10g of dried ginger and 15g of honey-fried licorice root. The preparation method prepares the formula into granules, and the granules are taken with boiled water 1 bag per time, 3 times per day and 1 hour after a meal. Order a re-visit after 1 week.

And B, diagnosis: the symptoms of chest distress and short breath of the patient are relieved, the urine volume is increased, edema of both lower limbs is relieved, cold hands and feet are improved, the tongue is pale and dark, the teeth marks on the side of the tongue, the tongue coating is thin and white, the pulse is deep, and the original prescription is kept for continuous treatment for 10 days.

Three diagnoses: after the patient moves, the traditional Chinese medicine composition has no obvious symptoms of chest distress and short breath, reduces the fatigue, warms hands and feet, forms stool, has a pale tongue with white fur and a deep pulse, and is treated by the Jinghe heart nourishing and original soothing formula for 10 days. Patients are revisited after one month, the disease condition is stable, the activity is free, and the asthma does not relapse.

Typical case 3

The patient is Zhang-a, male and 70 years old, and is admitted to the hospital for repeated chest distress and chest dull pain for more than 1 year, aggravated with wheezing and breathing for 5 days. The initial diagnosis is as follows: palpitation, dyspnea, chest distress, aggravation with exertion, inability to lie flat, cough with white foam phlegm, mental fatigue, hypodynamia, edema of both lower limbs. Poor sleep, big and clear, scanty urine. Dark tongue with teeth marks on the tongue edge, tortuous veins under the tongue, thin and white coating, and deep and thready pulse.

The traditional Chinese medicine diagnosis is asthma syndrome, qi deficiency and blood stasis syndrome of water retention. After comprehensive diagnosis, the basic treatment principle of 'tonifying qi, activating blood circulation, promoting diuresis, warming lung and dispelling cold' is determined.

Preparing a formula: jinghe Yangxin Shuwei, the specific prescription is as follows: 30g of rhodiola rosea, 30g of hairyvein agrimony, 15g of cassia twig, 15g of fried pepperweed seed, 30g of poria from Yunnan of China, 15g of salvia miltiorrhiza, 15g of dried ginger, 6g of asarum, 15g of schisandra chinensis and 15g of honey-fried licorice root. The preparation method prepares the formula into granules, orders to take the granules with boiled water, 1 bag/time, 3 times/day, takes the granules 1 hour after a meal, orders to take a doctor for a second visit after 3 days.

And B, diagnosis: the patient has the symptoms of chest distress, chest pain, dyspnea and tachypnea, increased urine volume, limb swelling, cough, white foam phlegm reduction, pale tongue, tongue margin and teeth mark reduction, deep and thready pulse, and is taken for 1 week above the order of advice.

Three diagnoses: the symptoms of chest distress and asthma are obviously relieved, the basic movement is free, the patient can lie flat, the swollen limbs are subsided, the tongue is light and white, the pulse is deep, the Jinghe Yangxin Shuyuan formula is continuously treated for follow-up after 10 days, the patient has stable illness state, the symptoms of chest distress, asthma, chest pain and the like do not relapse.

Typical case 4

The patient is admitted to the hospital for Yang, male and 52 years old, which is aggravated by abdominal distension and swollen limbs for 1 week due to repeated chest distress and shortness of breath and gasping for more than 3 months. The initial diagnosis is as follows: chest distress, palpitation, dyspnea and shortness of breath, especially after exercise, abdominal distension and anorexia, dizziness, mental fatigue and hypodynamia, sunken edema of the lumbosacral part and both lower limbs, dark and gloomy complexion and poor sleep. Scanty urine and loose stool. A dark and swollen tongue with marked teeth marks on the edge of the tongue and a deep pulse

The traditional Chinese medicine diagnoses the syndrome of heart water disease, qi deficiency, blood stasis and water retention. The comprehensive diagnosis determines that the basic treatment rule is 'tonifying qi, activating blood and promoting diuresis'.

Preparing a formula: jinghe Yangxin Shuwei, the specific prescription is as follows: 30g of rhodiola rosea, 30g of hairyvein agrimony, 10g of cassia twig, 20g of fried pepperweed seed, 30g of poria, 15g of salvia miltiorrhiza, 20g of radix stephaniae tetrandrae, 30g of astragalus mongholicus, 15g of bighead atractylodes rhizome and 10g of honey-fried licorice root. The preparation method prepares the formula into granules, orders to take the granules with boiled water, 1 bag/time, 3 times/day, takes the granules 1 hour after a meal, orders to take a doctor for a return visit 7 days later.

And B, diagnosis: the patients have short breath, chest distress, urine volume increase, limb swelling, dark red tongue, teeth mark on the side of tongue, thin and white fur, deep pulse, and can be treated for a second time after taking the medicine for 7 days.

Three diagnoses: the symptoms of chest distress, asthma and hypodynamia of the patient are obviously relieved, edema is relieved, appetite is increased, basic movement is free, no obvious abdominal distension exists, and stool is formed. The original prescription of Jinghe Yangxin Shu granule is continuously used for treating for 10 days, the symptoms of the patient basically disappear, the mental state is good, follow-up is carried out after healing, and the symptoms do not relapse.

Claims (10)

1. A pharmaceutical composition is characterized by comprising, by weight, 20-40 parts of rhodiola rosea, 30-60 parts of hairyvein agrimony, 5-20 parts of cassia twig, 5-20 parts of fried lepidium seed, 20-30 parts of poria cocos, 10-20 parts of salvia miltiorrhiza and 5-20 parts of honey-fried licorice root.

2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises, by weight, 10-30 parts of rhodiola rosea, 40-50 parts of agrimony, 10-15 parts of cassia twig, 10-15 parts of fried pepperweed seed, 15-25 parts of poria cocos, 12-18 parts of salvia miltiorrhiza and 10-15 parts of honey-fried licorice root.

3. The pharmaceutical composition according to claim 1 or 2, wherein the pharmaceutical composition further comprises 15-30 parts of radix Aconiti lateralis Preparata and 10-15 parts of rhizoma Zingiberis.

4. The pharmaceutical composition according to claim 1 or 2, wherein the Chinese medicinal composition further comprises 10-15 parts of dried ginger, 3-6 parts of asarum and 10-15 parts of schisandra chinensis.

5. The pharmaceutical composition according to claim 1 or 2, wherein the Chinese medicinal composition further comprises 15-20 parts of radix stephaniae tetrandrae, 30-80 parts of astragalus membranaceus and 15-30 parts of bighead atractylodes rhizome.

6. A pharmaceutical preparation of the pharmaceutical composition according to any one of claims 1 to 5, wherein pharmaceutically acceptable excipients are added to the prescription of the pharmaceutical composition to prepare any one of decoction, pill, tablet, capsule, paste, syrup, granule, powder and powder.

7. The method for preparing the pharmaceutical composition preparation of claim 6, wherein the method for preparing the granules comprises:

(1) decocting: the weight ratio of the medicinal materials except the cassia twig in the prescription is 1: 6-1: 12 adding water and decocting for 1-3 times, each time for 30-90 min, and combining the decoction;

(2) concentration: concentrating the obtained decoction into thick paste at the temperature of 55-75 ℃ and the vacuum degree of-0.02-0.06 MPa, wherein the density of the thick paste is 1.20-1.35 g/ml at the temperature of 50-60 ℃;

(3) and (3) drying: drying the thick paste at 65-75 ℃ and under the vacuum degree of-0.02-0.06 MPa to obtain dry paste, crushing and sieving by a 100-mesh sieve to obtain dry paste powder for later use;

(4) weighing cassia twig according to the weight parts in the formula, mixing the cassia twig with the dry paste powder, adding 20-40 g of granulation auxiliary materials, uniformly mixing, adding a proper amount of 60-95% ethanol, carrying out wet granulation, and drying to obtain the granules.

8. The method for preparing the pharmaceutical composition according to claim 7, wherein the granulation excipient is one or more of dextrin, maltodextrin or sucrose.

9. The method for preparing a pharmaceutical composition preparation according to claim 6, wherein the method for preparing the pill comprises:

(1) decocting: weighing rhodiola rosea, cassia twig, poria cocos and salvia miltiorrhiza in the formula according to parts by weight, crushing into fine powder, and sieving with a 100-mesh sieve for later use; the other medicinal materials are weighed according to the formula amount, and the weight ratio of the medicinal water is 1: 6-1: 12 adding water and decocting for 1-3 times, each time for 30-90 min, and combining the decoction;

(2) concentration: concentrating the obtained decoction into thick paste at the temperature of 55-75 ℃ and the vacuum degree of-0.02-0.06 MPa, wherein the density of the thick paste is 1.20-1.35 g/ml at the temperature of 50-60 ℃;

(3) and (3) drying: drying the thick paste at 65-75 ℃ and under the vacuum degree of-0.02-0.06 MPa to obtain dry paste, crushing and sieving by a 100-mesh sieve to obtain dry paste powder for later use;

(4) mixing the pulverized fine powder with the dry extract powder, and making into pill with water or 30% or less ethanol.

10. The application of the Jinghe Yangxin Shu Chinese medicinal composition according to any one of claims 1 to 6 in preparing a medicament for treating chronic heart failure or in preparing a medicament for treating qi deficiency, blood stasis and water retention.

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