Traditional Chinese medicine composition as well as preparation method and application thereof

Through a traditional Chinese medicine composition containing sputum, phyton, pineapple, cicada, trichosanthes kirilowii, coptis chinensis, antelope horn powder and yamrosophila, the existing Chinese patent medicines are solved by failing to effectively treat phlegm and heat disturbed atrial fibrillation. Problem, achieving significant improvements in symptoms and reducing complication risk.

CN119424565APending Publication Date: 2025-02-14GUANGANMEN HOSPITAL CHINA ACAD OF CHINESE MEDICAL SCI
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Patent Information

Application Number
CN202411043760.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-07-31
Filing Date
2024-07-31
Publication Date
2025-02-14

AI Technical Summary

Technical Problem

Existing Chinese patent medicines have not clearly stated that they can treat atrial fibrillation, especially sputum-heat-internal atrial fibrillation.

Method used

Provided is a traditional Chinese medicine composition, including cypress stone, phyton, pineapple, cicada, whole Trichosanthes kirilowii, coptis chinensis, antelope horn powder and yellowii, and treat phlegm and heat-clearing, qi-unblocking meridians by resolving phlegm and clearing heat, promoting qi and unblocking meridians. trembling.

Benefits of technology

Significantly improve the clinical symptoms of patients, reduce the rate of rehospitalization, disability and mortality, and there are no adverse reactions in long-term use.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition and a preparation method and application thereof. Aiming at pathogenesis treatment of phlegm-heat internal disturbance type atrial fibrillation, the traditional Chinese medicine composition is formed by compounding multiple traditional Chinese medicine components, active components of the medicines have a mutual synergistic effect, in the formula, lapis chloriti has the effects of descending qi and dissolving phlegm, tabasheer has the effects of clearing heat and eliminating phlegm, rhizoma nardostachyos has the effects of regulating qi and relieving depression, cicada slough has the effects of dissipating heat and dispelling wind, and the effects of clearing heat and eliminating phlegm are achieved. The rhizoma coptidis has the effects of clearing heat, eliminating phlegm and drying dampness, the antelope horn powder has the effects of clearing heat and calming endogenous wind, and the rhizoma corydalis has the effects of promoting qi to activate blood. The traditional Chinese medicine is used for comprehensively treating various pathological factors of phlegm-heat internal disturbance type atrial fibrillation, and is remarkable in curative effect and outstanding in effect.
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Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition, a preparation method and use thereof. Background Art

[0002] Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence increases with age. With the aging of the population, the prevalence and incidence of AF continue to rise. AF can cause severe thromboembolism, stroke, malignant heart failure, vascular cognitive impairment and other serious complications, causing repeated hospitalization, disability and even death of patients, and bringing heavy economic and medical burdens to patients' families and society.

[0003] Atrial fibrillation can be included in the category of "heart palpitations", "palpitations" and "fright palpitations" in traditional Chinese medicine. Its pathogenesis is always the main deficiency and superficial excess, but it has its own pathogenesis characteristics. Currently, the Chinese patent medicines on sale for the treatment of heart palpitations or arrhythmias include Shensong Yangxin Capsules, Yixinshu Tablets, Xinkeshu Tablets, etc., but none of them clearly indicate that they can treat atrial fibrillation. Summary of the invention

[0004] Therefore, the technical problem to be solved by the present invention is to provide a Chinese medicine composition, a preparation method and a use thereof, wherein the Chinese medicine composition can treat atrial fibrillation, especially in treating phlegm-heat internal disturbance type atrial fibrillation.

[0005] To this end, the present invention provides the following technical solutions:

[0006] A traditional Chinese medicine composition comprises the following raw materials: bluestone, rhizoma dahliae, rhizoma nardii, cicada shell, whole trichosanthes root, rhizoma coptidis, antelope horn powder and rhizoma yanhusuo.

[0007] Optionally, the raw materials include the following parts by weight:

[0008] 10-30 parts by weight of qingyanshi, 3-9 parts by weight of dianthus, 9-15 parts by weight of nardostachys grandiflora, 9-15 parts by weight of cicada shells, 10-30 parts by weight of whole trichosanthes, 3-9 parts by weight of coptis root, 0.2-0.5 parts by weight of antelope horn powder and 9-15 parts by weight of yanhusuo.

[0009] Optionally, the raw materials include the following parts by weight:

[0010] 15 parts by weight of qinglanshi, 6 parts by weight of dianthus, 12 parts by weight of nardostachys grandiflora, 12 parts by weight of cicada shells, 15 parts by weight of whole trichosanthes, 6 parts by weight of coptis root, 0.3 parts by weight of antelope horn powder and 12 parts by weight of yanhusuo.

[0011] A method for preparing the Chinese medicine composition comprises the following steps:

[0012] S1. Weighing greenstone according to the formula, extracting to obtain an extract;

[0013] S2, according to the formula, weighed Radix Glehniae, Rhizoma Nardostachys, Periostracum Cicadae, Fructus Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis, mixed, then added the extract in step S1, then extracted, filtered, and obtained extract 1 and medicinal residues;

[0014] S3, extracting and filtering the medicinal residue in step S2 to obtain extract 2 and medicinal residue;

[0015] S4. Combine extract 1 and extract 2 to obtain a mixed extract, concentrate it, and then add antelope horn powder weighed according to the formula.

[0016] Optionally, in step S1, the extraction conditions are as follows: water is added to the greenstone, the weight ratio of the added water to the greenstone is (1-15):1, the decoction temperature is 60-100°C, and the decoction time is 0.5-1h.

[0017] Optionally, in step S2, the extraction is a heated water extraction;

[0018] Optionally, in step S2, the temperature of the heated water extraction is 60-100°C, the heating extraction time is 1-5h / time, and the number of extractions is 1-5 times; preferably, the heating extraction time is 2-5h / time;

[0019] Optionally, in step S2, the temperature of the heated water extraction is 80-100°C;

[0020] Optionally, in step S2, according to the formula, Radix Glechomae Dahuricae, Rhizoma Nardostachys, Periostracum Cicadae, Fructus Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis are weighed and mixed to obtain a mixed raw material, firstly added with water for soaking, the weight of the added water being in a ratio of (1-15):1 to the weight of the mixed raw material, and then soaked for 20-90 min; preferably, the soaking time is 30-60 min, more preferably 30 min;

[0021] Optionally, in step S2, the ratio of the weight of the added water to the weight of the mixed raw materials is (5-15):1, more preferably (6-12):1, and even more preferably (6-8):1.

[0022] Optionally, in step S3, the extraction is water extraction by heating;

[0023] Optionally, in step S3, the temperature of the heated water extraction is 60-100°C, the heating extraction time is 1-5h / time, and the number of extractions is 1-5 times; preferably, the heating extraction time is 1-3h / time;

[0024] Optionally, in step S3, the temperature of the heated water extraction is 80-100°C;

[0025] Optionally, in step S3, the ratio of the weight of the added water to the weight of the medicinal residue in step S2 is (1-15):1; preferably, the ratio of the weight of the added water to the weight of the medicinal residue in step S2 is (6-8):1, and further preferably is 6:1.

[0026] Optionally, in step S4, the mixed extract is concentrated by reduced pressure evaporation under vacuum, the concentration temperature is 80-100° C., and the relative pressure during concentration is -0.05 to -0.1 MPa;

[0027] Optionally, in step S4, the concentration temperature is 80° C., and the relative pressure during concentration is -0.05 to -0.095 MPa; preferably, the relative pressure during concentration is -0.07 MPa.

[0028] Optionally, in step S4, the mixed extract is subjected to heating evaporation treatment at normal pressure, and the mixed extract is heated at an absolute pressure of 1 atm, and the heating temperature is 80-100° C.;

[0029] Optionally, in step S4, the relative density of the mixed concentrated solution obtained in the concentration step is 1.05-1.5, preferably 1.1-1.5, and more preferably 1.1-1.3.

[0030] Optionally, in step S4, the particle size of the antelope horn powder is ≤15 μm; preferably, 1-15 μm; further preferably, 10-15 μm.

[0031] A Chinese medicine preparation, comprising the Chinese medicine composition or the Chinese medicine composition prepared by the preparation method of the Chinese medicine composition as an active ingredient, with or without adding pharmaceutical excipients, to prepare a clinically acceptable dosage form;

[0032] Optionally, the dosage form includes capsules, tablets, granules, pills, powders or oral liquids;

[0033] Optionally, the pharmaceutical excipients include but are not limited to starch, dextrin, lactose, microcrystalline cellulose, gelatin, sucrose or magnesium stearate.

[0034] Use of the Chinese medicine composition, the Chinese medicine composition prepared by the method for preparing the Chinese medicine composition, or the Chinese medicine preparation in preparing medicines and / or health products for treating atrial fibrillation;

[0035] Optionally, the atrial fibrillation is atrial fibrillation caused by phlegm-heat internal disturbance.

[0036] The Chinese medicine composition for phlegm-heat internal disturbance type atrial fibrillation of the present invention can be made into a clinically acceptable oral dosage form with pharmaceutically acceptable excipients according to traditional or modern production processes. Such as capsules, tablets, granules, pills, oral liquids, etc. The pharmaceutical excipients used can be selected from pharmaceutically acceptable carriers in reference books such as "Handbook of Pharmaceutical Excipients" (2nd Edition, edited by A. Wade and PJ Weller; published by American Pharmaceutical Association, Washington and The Pharmaceutical Press, London, 1994), such as starch, dextrin, lactose, microcrystalline cellulose, gelatin, sucrose, magnesium stearate, etc. Clinically, long-term medication is required, and solid preparations are convenient for storage, convenient for patients to take, and more in line with market demand. Preferred dosage forms are capsules, granules, tablets, pills, powders, oral liquids, etc.

[0037] Based on the experience of predecessors and combined with his own clinical practice for many years, Chief Physician Hu Yuanhui proposed that deficiency, wind, heat, blood stasis and phlegm are the five major pathological factors of atrial fibrillation. In the process of the occurrence and development of atrial fibrillation, the above pathological factors are often mutually causal and synergistic. Its pathogenicity is often complex and changeable, but at the same time it has its own rules to follow. Among them, phlegm-heat disturbance is the key factor leading to the onset of atrial fibrillation. Clinically, atrial fibrillation often has a long course, repeated attacks, is difficult to cure, and is easy to relapse after recovery. The disease is stubborn, which is similar to the pathogenic characteristics of phlegm and dampness in traditional Chinese medicine, "phlegm and dampness are sticky, lingering and difficult to cure". The heart is the organ of the monarch fire, the heart governs blood, the monarch fire is yang, and the blood is yin. Under physiological conditions, the monarch fire warms the blood, and the blood nourishes the monarch fire. The monarch fire and blood are mutually rooted and used, and coordinated with each other. When yin and yang are balanced, the heart is calm and the mind is at peace. If blood is deficient due to various reasons, the heart fire cannot be nourished, resulting in excessive heart fire, heat disturbing the mind, and palpitations. Phlegm and heat (fire) are very easy to get stuck. Phlegm and dampness can easily turn into heat when they are accumulated for a long time, while fire and heat can easily burn body fluids and produce phlegm. Phlegm and heat are intertwined, blocking the heart meridian, causing poor blood circulation, disturbing the mind, and causing abnormal heartbeats, resulting in palpitations.

[0038] The present invention targets the syndrome of atrial fibrillation with phlegm-heat disturbance, and selects a prescription for resolving phlegm and clearing heat. The Chinese medicine combination prescription takes resolving phlegm and clearing heat as the main idea, and at the same time targets the wind-like tremor of atrial fibrillation, uses drugs for dispelling wind and stopping tremors. Among them, Qinglanshi descends qi and eliminates phlegm, and Tianzhuhuang clears heat and dispels phlegm, which are the main drugs. Gansong regulates qi and harmonizes the stomach, cicada shell dissipates heat and dispels wind, whole trichosanthes eliminates phlegm and opens knots, regulates qi and relieves chest tightness, and Coptis chinensis clears heat, dries dampness and eliminates phlegm, which are the minister drugs, helping the main drugs to resolve phlegm and clear heat. Antelope horn powder clears heat and calms wind, and Yanhusuo promotes qi and activates blood circulation, which are the assistant drugs.

[0039] Qinglanshi tastes sweet and salty, is neutral in nature, and belongs to the lung and liver meridians. It has the effects of descending qi, eliminating phlegm, calming the liver and calming the nerves. "Compendium of Materia Medica" says: "Qianlanshi has a neutral taste and salty taste. Its nature is downward, it is yin, and it is a medicine for the Jueyin meridian. When the wind and wood of the liver meridian are too much, it controls the spleen and earth, and the qi cannot be transported and transformed, and stagnation produces phlegm, which blocks the upper and middle burners and causes wind-heat diseases. Therefore, this medicine is suitable for heavy and falling." "Compendium of Materia Medica" says: "Lianlanshi has the nature of being strong and fierce among stones, and it is heavy and descends. It can eliminate all accumulated phlegm. It tastes spicy and salty, and has a neutral and non-toxic taste. Spicy is used to disperse knots, salty is used to soften hard masses, and heavy is used to descend. Therefore, all the symptoms described in "Ben Jing" are consistent." Modern pharmacological research shows that Qinglanshi contains a large amount of Fe 3+ , Fe 2+ 、Al 3+ , Mn 2+ And a small amount of Mg + 、SiO - Plasma can promote cation exchange and produce adsorption, thereby achieving the effect of resolving phlegm and promoting diuresis.

[0040] Tianzhuhuang, also known as Tianzhuhuang, Zhugao, and Zhutang. "Linhai Zhi" says: "It grows in Tianzhu country", so it is named Tianzhuhuang. Kou Zongshi said: "This is grown inside bamboo, like yellow soil on bamboo", so it is named Zhuhuang. Its nature and flavor are sweet and cold, and it enters the heart, liver, and gallbladder meridians. This medicine can clear away heat and eliminate phlegm, cool the heart and calm the nerves. It can be used for patients with fever, delirium, aphasia due to stroke, and convulsions in children due to heat phlegm. Li Zhongzi said in "Leigong Paoyao Xingjie": "The coldness of Zhuhuang is specifically used to drain the fire of Shaoyin. When the fire is gone, all the symptoms of shock and evil will be cured." Miao Xiyong said in "Ben Cao Jing Shu": "Tian Zhu Huang has a slightly cold air and a slightly slow nature, so it is an important medicine for children. It enters the Shaoyin meridian of the hand, and treats children's convulsions, wind and heat, just like the symptoms of extreme heat and wind in adults. This medicine can remove heat and nourish the heart, clear phlegm and open the orifices. The heat in the heart is cleared and the convulsions are relieved. The monarch is at peace and the five internal organs are nourished, so all symptoms are eliminated." "Ben Cao Bei Yao" says: "Cool the heart meridian, remove wind and heat, open the orifices and clear phlegm, calm the liver and improve eyesight." Modern pharmacological research shows that Tian Zhu Huang mainly contains potassium hydroxide, silica, etc., which has the effects of expectoration, antibacterial, anti-inflammatory, and heart inhibition and blood pressure lowering.

[0041] Nardostachys odoratus is sweet and warm in nature. The Kaibao Materia Medica states that it is sweet, warm and non-toxic. It enters the spleen and stomach meridians. The Bencao Huiyan states that it enters the Taiyin and Yangming meridians of the foot. Nardostachys odoratus has the effects of regulating qi and relieving pain, invigorating the spleen and strengthening the stomach. The Supplement to Materia Medica states that it is used to treat dark skin, rash, tooth decay, and hemorrhoids caused by pheasants. The Rihuazi Materia Medica states that it is used to treat abdominal distension and lower gas. The Kaibao Materia Medica states that it is used to treat bad gas and sudden abdominal pain and fullness. Modern pharmacological studies have shown that valerian in Nardostachys odoratus has an anti-arrhythmic effect, and its inhibition of ectopic ventricular rhythm is stronger than that of quinidine and Nardostachys odoratus volatile oil. Its inhibition of damaged atrial flutter and aconitine-induced atrial fibrillation is the same as that of quinidine. The volatile oil extracted from the root of Nardostachys odoratus has a weaker effect than quinidine in slowing conduction in various heart specimens.

[0042] The cicada shell tastes sweet and is cold in nature. The "Famous Doctors' Records" says: "It has a salty, sweet, cold and non-toxic taste." It belongs to the lung and liver meridians. It has the effects of dispersing wind-heat, relieving sore throat, relieving itching, removing cataracts and improving eyesight, and dispelling wind and stopping spasms. The "Compendium of Materia Medica" says: "Cicadas are transformed from the residual air of earth and wood, drinking wind and sucking dew, and their air is clear and empty. Therefore, they are mainly used to treat all wind-heat syndromes." The "Compendium of Materia Medica" says: "Cicadas are endowed with the residual air of water and soil, transformed into shape, and their flying and singing get the fresh air of wind and dew, so they can enter the liver to dispel wind and heat." Modern pharmacological studies have shown that cicada shells have sedative and anticonvulsant effects, as well as immunosuppressive and anti-allergic effects. In addition, cicada shells can significantly slow down the heart rate of rabbits, and their decoction has the effect of blocking the conduction of the superior cervical sympathetic ganglion.

[0043] Trichosanthes is a perennial herbaceous vine of the Cucurbitaceae family, and the Chinese medicine Trichosanthes is its mature peel and seeds. When the fruit is ripe in autumn, cut it with the stalk, hang it to dry, and then it can be used. Trichosanthes is sweet and cold in nature. It belongs to the lung, stomach, and large intestine meridians. It has the effects of clearing the lungs and resolving phlegm, regulating qi and widening the chest. It is mainly used for lung heat cough, turbid yellow and thick phlegm, chest pain, chest congestion, breast abscess, lung abscess, intestinal abscess swelling and pain, and constipation. According to analysis, the chemical components of Trichosanthes mainly contain triterpenoid saponins, organic acids, resins, sugars, fatty oils, pigments and other ingredients. Pharmacological studies have shown that the total amino acids in the peel of Trichosanthes have an expectorant effect; the laxative substances contained in Trichosanthes have a laxative effect; it can also reduce blood cholesterol and triglycerides, and increase coronary flow and expand the coronary artery; it also has antibacterial, anti-cancer, anti-ulcer and anti-aging effects.

[0044] Coptis chinensis is cold in nature and bitter in taste. It enters the heart, gallbladder, spleen, stomach, and large intestine meridians. "Ren Zhai Zhi Zhi Fang" says: "It can remove the bad blood in the heart orifices" and has the function of "clearing heat and drying dampness, purging fire and detoxifying". It is used to treat high fever caused by febrile evil entering the heart meridian; irritability; delirium or vomiting and bleeding caused by excessive heat forcing blood to flow; damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactivity of heart fire, restlessness and insomnia, vomiting and bleeding caused by blood heat, red eyes, toothache, thirst, carbuncle, furuncle; external treatment of eczema, wet sores, and pus in the ear canal. Wine-boiled coptis chinensis is good at clearing the heat of the upper jiao, and is used for red eyes and mouth sores. Coptis chinensis mainly contains berberine, coptis pine, epiberberine, berberrubine, jatrorrhizine, magnolia pine, methyl coptis pine, palmate leaf tetrandrine, african pine alkaloids and other alkaloids, as well as phellodendron ketone, ferulic acid, phellodendron lactone and other ingredients. Modern pharmacological studies have shown that berberine, epiberberine, berberine and other alkaloid components in Coptis chinensis can all exert antiarrhythmic effects, among which berberine has significant therapeutic effects on various types of arrhythmias and has a broad-spectrum antiarrhythmic effect.

[0045] Antelope horn is salty and cold in nature. It is in the liver and heart meridians. It has the effects of calming the liver and calming the wind, clearing the liver and improving eyesight, dispersing blood and detoxifying. Antelope horn mainly enters the liver meridian. It is salty, cold and heavy in nature. It is good at clearing liver heat, calming the liver and calming the wind, calming the nerves and relieving spasms. Therefore, it is an important medicine for treating epilepsy and convulsions, especially those caused by extreme heat and wind. "Famous Doctors' Records" says: "It tastes bitter, slightly cold, and non-toxic. It is mainly used to treat typhoid fever, seasonal cold and heat, heat in the skin, warm wind poison hidden in the bones, and eliminates depression, nightmares, madness, absurdity, and food choking. Long-term use strengthens muscles and bones, lightens the body and raises yin, invigorates qi, and benefits men." "Yao Xing Lun" says: "It is sweet in taste. It can treat all hot and toxic wind attacks, evil toxic wind, sudden death, confusion and loss of consciousness, and disperse postpartum blood rushing to the heart and depression. Burn the powder and take it with wine. It is mainly used for children's epilepsy, mountain miasma, and can disperse bad blood. Burning ash can treat choking." Modern pharmacological research shows that antelope horns mainly contain keratin, which can be hydrolyzed to obtain 18 kinds of amino acids and polypeptide substances. It also contains a variety of phospholipids, calcium phosphate, cholesterol, vitamin A, etc. In addition, it contains a variety of trace elements. The extract of antelope horn skin has an inhibitory effect on the central nervous system, analgesic effect, and can enhance the animal's ability to tolerate hypoxia. The decoction has anticonvulsant and antipyretic effects. The decoction or alcohol extract has a hypotensive effect. A small dose can strengthen the contraction of the isolated toad heart, and a medium or large dose can inhibit the heart.

[0046] Yanhusuo, also known as Yuanhusuo, Yanhusuo, Xuanhusuo, and Yuanhusuo, is the dried tuber of the perennial poppy shell plant Yanhusuo; Yanhusuo has a pungent, bitter, and warm nature, and is in the liver, spleen, and heart meridians. It can not only promote blood circulation, but also promote qi circulation, and is an important medicine for promoting qi circulation and relieving pain. "Compendium of Materia Medica" says: "It can promote qi stagnation in blood and blood stagnation in qi, so it is specially used to treat all kinds of pain in the body, and is the first-class medicine for promoting blood circulation and qi circulation." Modern pharmacological studies have shown that Yanhusuo alcohol extract can dilate coronary arteries, reduce coronary resistance, increase coronary blood flow, improve myocardial tolerance to hypoxia, inhibit platelet aggregation, and resist thrombosis. Yanhusuo total alkaloids can resist arrhythmia, and dehydrogenated Yanhusuo A can occasionally protect myocardial cells and resist myocardial ischemia.

[0047] The Chinese medicine composition for treating phlegm-heat internal disturbance type atrial fibrillation of the present invention is derived from the empirical prescription obtained by long-term exploration and optimization by Hu Yuanhui, chief physician of Guang'anmen Hospital. After long-term application in clinical practice, it is found that the medicine composition can significantly improve the clinical symptoms of patients after taking the medicine, has no adverse reactions found after long-term taking, has no toxic side effects, prolongs the medication time, has a simple preparation process, has stable product quality and obvious effects, and is easy to use, thus filling the gap in the market of Chinese patent medicines for treating phlegm-heat internal disturbance type atrial fibrillation.

[0048] The technical solution of the present invention has the following advantages:

[0049] 1. The present invention provides a traditional Chinese medicine composition for the treatment of the pathogenesis of atrial fibrillation caused by phlegm-heat internal disturbance. The traditional Chinese medicine composition is composed of a plurality of traditional Chinese medicine ingredients, wherein the active ingredients of the medicines have a synergistic effect. The Qinglanshi in the formula can relieve qi and eliminate phlegm, Tianzhuhuang can clear heat and resolve phlegm, Gansong can regulate qi and relieve depression, Cicadae can dissipate heat and dispel wind, Quanguaoluo can regulate qi and relieve chest tightness, resolve phlegm and relieve knots, Coptis chinensis can clear heat, resolve phlegm and dry dampness, Antelope horn powder can clear heat and calm wind, and Corydalis can promote qi and activate blood circulation. Comprehensive treatment of multiple pathological factors is adopted for atrial fibrillation caused by phlegm-heat internal disturbance, and the treatment effect is good and the effect is outstanding.

[0050] Furthermore, in the Chinese medicine composition, since the green stone and Tianzhuhuang can dissipate phlegm, clear heat and stop tremors; the cicada shell and antelope horn powder can clear heat, dispel wind and stop tremors, the pathological factors of atrial fibrillation are eliminated, and the characteristics of atrial fibrillation that is like wind are also taken into consideration, and the wind is stopped and the tremors are stopped. In addition, the whole Trichosanthes, Nardostachys grandiflora, and Corydalis yanhusuo can regulate the qi, unclog the meridians, and make the phlegm and heat flow out along the meridians, and at the same time make the blood flow unobstructed, not easy to be blocked, and prevent thrombosis. The whole prescription is suitable for the syndrome of phlegm-heat internal disturbance and the state of continuous atrial fibrillation, and can reduce the patient's re-hospitalization rate, disability rate and mortality rate.

[0051] Furthermore, the Chinese medicine composition for atrial fibrillation of phlegm-heat internal disturbance type of the present invention achieves the purpose of improving clinical symptoms by resolving phlegm and clearing heat, promoting qi and unblocking collaterals, and pays more attention to the improvement effect on the phlegm-heat internal disturbance syndrome type, and can prevent or delay the occurrence of clinical complications while alleviating symptoms.

[0052] 2. The preparation method of the Chinese medicine composition of the present invention is simple, the process conditions are mild, the cost is low, the expense is low, the clinical health care cost is saved, and it is suitable for market promotion and application, so that more patients can benefit from it. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0054] Figure 1 These are the AFD results of rats in each group in Example 1 of the present invention. DETAILED DESCRIPTION

[0055] The following examples are provided for a better understanding of the present invention, but are not intended to limit the best mode of implementation, nor to limit the content and protection scope of the present invention. Any product identical or similar to the present invention obtained by anyone under the inspiration of the present invention or by combining the features of the present invention with other prior arts shall fall within the protection scope of the present invention.

[0056] If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in the field can be used. If no manufacturer is specified for the reagents or instruments used, they are all conventional reagent products that can be obtained commercially.

[0057] Example

[0058] Table 1. Formula of Chinese medicine composition

[0059]

[0060]

[0061] Preparation method of the Chinese medicine composition of embodiment 1

[0062] Preparation method:

[0063] (1) Weighing celite according to the formula, adding water to the celite, the weight ratio of the added water to the celite being 8:1, the decoction temperature being 80°C, the decoction time being 0.8h, and obtaining extract 1;

[0064] (2) According to the formula, Radix Glechomae Dahuricae, Rhizoma Nardostachys, Periostracum Cicadae, Radix Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis are weighed and mixed to obtain a mixed raw material, which is first soaked in water, wherein the ratio of the weight of the added water to the weight of the mixed raw material is 6:1, and then soaked for 30 minutes, and then the extract in step (1) is added, followed by heating extraction, heating to 80° C., the heating extraction time is 3 hours / time, the number of extractions is 3 times, filtering, combining the extract and the residue, and obtaining an extract 1 and the residue, respectively.

[0065] (3) Add water to the medicinal residue in step (2), with the ratio of the weight of the added water to the weight of the medicinal residue in step (2) being 6:1, and perform heating extraction. The heating extraction time is 3 hours / time, and the number of extractions is 3 times. Filter, combine the extract and the medicinal residue to obtain extract 2 and medicinal residue, respectively.

[0066] (4) Combine extract 1 and extract 2 to obtain a mixed extract, and perform reduced pressure evaporation concentration under vacuum conditions. The concentration temperature is 80° C., and the relative pressure during concentration is -0.07 MPa. The relative density of the obtained mixed concentrate is 1.1-1.3. Then, add antelope horn powder (particle size is 15 μm) weighed according to the formula and mix well.

[0067] Preparation method of the Chinese medicine composition of embodiment 2

[0068] Preparation method:

[0069] (1) Weighing celite according to the formula, adding water to the celite, the weight ratio of the added water to the celite being 1:1, the decoction temperature being 100° C., the decoction time being 0.5 h, and obtaining extract 1;

[0070] (2) According to the formula, Radix Glechomae Dahuricae, Rhizoma Nardostachys, Periostracum Cicadae, Radix Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis are weighed and mixed to obtain a mixed raw material, which is first soaked in water, wherein the ratio of the weight of the added water to the weight of the mixed raw material is 8:1, and then soaked for 60 minutes, and then the extract in step (1) is added, followed by heating extraction, heating to 100° C., the heating extraction time is 5 h / time, the number of extractions is 1, filtering, combining the extract and the residue, and obtaining extract 1 and the residue, respectively.

[0071] (3) Add water to the medicinal residue in step (2), wherein the ratio of the weight of the added water to the weight of the medicinal residue in step (2) is 8:1, and then heat extraction is performed, heating to 100° C., the heating extraction time is 1 h / time, the number of extractions is 1, filtering, combining the extract and the medicinal residue, and obtaining extract 2 and medicinal residue, respectively.

[0072] (4) Combine extract 1 and extract 2 to obtain a mixed extract, and perform reduced pressure evaporation concentration under vacuum conditions. The concentration temperature is 80° C., and the relative pressure during concentration is -0.05 MPa. The relative density of the obtained mixed concentrate is 1.1-1.5. Then, add antelope horn powder (particle size is 10 μm) weighed according to the formula and mix well.

[0073] Preparation method of the Chinese medicine composition of embodiment 3

[0074] Preparation method:

[0075] (1) Weighing celite according to the formula, adding water to the celite, the weight ratio of the added water to the celite being 5:1, the decoction temperature being 70°C, the decoction time being 0.6h, and obtaining extract 1;

[0076] (2) According to the formula, Radix Glechomae Dahuricae, Rhizoma Nardostachys, Periostracum Cicadae, Radix Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis are weighed and mixed to obtain a mixed raw material, which is first soaked in water, wherein the ratio of the weight of the added water to the weight of the mixed raw material is 12:1, and then soaked for 20 minutes, followed by adding the extract in step (1), and then performing heating extraction, heating to 60° C., the heating extraction time is 1 h / time, the number of extractions is 2, filtering, combining the extract and the residue, and obtaining an extract 1 and the residue, respectively.

[0077] (3) Add water to the medicinal residue in step (2), wherein the ratio of the weight of the added water to the weight of the medicinal residue in step (2) is 7:1, and then perform heating extraction, heating to 60° C., the heating extraction time is 5 h / time, the number of extractions is 2 times, filtering, combining the extract and the medicinal residue, and obtaining extract 2 and medicinal residue, respectively.

[0078] (4) Combine extract 1 and extract 2 to obtain a mixed extract, and perform reduced pressure evaporation concentration under vacuum conditions. The concentration temperature is 100° C., and the relative pressure during concentration is -0.095 MPa. The relative density of the obtained mixed concentrate is 1.05-1.5. Then, add antelope horn powder (particle size is 1 μm) weighed according to the formula and mix well.

[0079] Preparation method of the Chinese medicine composition of embodiment 4

[0080] Preparation method:

[0081] (1) Weighing celite according to the formula, adding water to the celite, the weight ratio of the added water to the celite being 10:1, the decoction temperature being 90° C., the decoction time being 0.9 h, and obtaining extract 1;

[0082] (2) According to the formula, Radix Glechomae Dahuricae, Rhizoma Nardostachys, Periostracum Cicadae, Radix Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis are weighed and mixed to obtain a mixed raw material, which is first soaked in water, wherein the ratio of the weight of the added water to the weight of the mixed raw material is 5:1, and then soaked for 90 minutes, and then the extract in step (1) is added, followed by heating extraction, heating to 80° C., the heating extraction time is 2 h / time, the number of extractions is 4 times, filtering, combining the extract and the residue, and obtaining an extract 1 and the residue, respectively.

[0083] (3) Add water to the medicinal residue in step (2), wherein the ratio of the weight of the added water to the weight of the medicinal residue in step (2) is 1:1, and then perform heating extraction, heating to 70° C., the heating extraction time is 4 h / time, the number of extractions is 4 times, filtering, combining the extract and the medicinal residue, and obtaining extract 2 and medicinal residue, respectively.

[0084] (4) Combine extract 1 and extract 2 to obtain a mixed extract, and perform reduced pressure evaporation concentration under vacuum conditions. The concentration temperature is 90° C., and the relative pressure during concentration is -0.1 MPa. The relative density of the obtained mixed concentrate is 1.05-1.5. Then, add antelope horn powder (particle size is 10 μm) weighed according to the formula and mix well.

[0085] Preparation method of the Chinese medicine composition of embodiment 5

[0086] Preparation method:

[0087] (1) Weighing celite according to the formula, adding water to the celite, the weight ratio of the added water to the celite being 13:1, the decoction temperature being 70°C, the decoction time being 0.9h, and obtaining extract 1;

[0088] (2) According to the formula, Radix Glechomae Dahuricae, Rhizoma Nardostachys, Periostracum Cicadae, Radix Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis are weighed and mixed to obtain a mixed raw material, which is first soaked in water, wherein the ratio of the weight of the added water to the weight of the mixed raw material is 15:1, and then soaked for 20 minutes, and then the extract in step (1) is added, followed by heating extraction, heating to 70° C., the heating extraction time is 1 to 5 h / time, the number of extractions is 5, filtering, combining the extract and the residue, and obtaining an extract 1 and the residue, respectively.

[0089] (3) Add water to the medicinal residue in step (2), wherein the ratio of the weight of the added water to the weight of the medicinal residue in step (2) is 15:1, and then perform heating extraction, heating to 90° C., the heating extraction time is 2 h / time, the number of extractions is 5 times, filtering, combining the extract and the medicinal residue, and obtaining extract 2 and medicinal residue, respectively.

[0090] (4) Combine extract 1 and extract 2 to obtain a mixed extract, and perform reduced pressure evaporation concentration under vacuum at a concentration temperature of 90° C. The relative pressure during concentration is -0.05 MPa. The relative density of the obtained mixed concentrate is 1.05-1.5. Then, add antelope horn powder (particle size 8 μm) weighed according to the formula and mix well.

[0091] Preparation method of the Chinese medicine composition of embodiment 6

[0092] The formula of the Chinese medicine composition of this embodiment is the same as that of Example 5, except that the preparation method is as follows:

[0093] (1) Weighing celite according to the formula, adding water to the celite, the weight ratio of the added water to the celite being 15:1, the decoction temperature being 60°C, the decoction time being 1 hour, and obtaining extract 1;

[0094] (2) According to the formula, Radix Glechomae Dahuricae, Rhizoma Nardostachys, Periostracum Cicadae, Radix Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis are weighed and mixed to obtain a mixed raw material, which is first soaked in water, wherein the ratio of the weight of the added water to the weight of the mixed raw material is 1:1, and then the extract in step (1) is added, and then heated to 90° C., the heating extraction time is 1 to 5 h / time, the number of extractions is 4, and the extraction is filtered, and the extract and the residue are combined to obtain an extract 1 and a residue, respectively.

[0095] (3) Add water to the medicinal residue in step (2), with the ratio of the weight of the added water to the weight of the medicinal residue in step (2) being 10:1, and then heat to 100° C., heat extraction time for 3 h / time, extraction times for 4 times, filter, combine the extract and the medicinal residue, and obtain extract 2 and medicinal residue, respectively.

[0096] (4) Combine extract 1 and extract 2 to obtain a mixed extract, and subject the mixed extract to a heating evaporation treatment at normal pressure. Heat the mixed extract at an absolute pressure of 1 atm at a heating temperature of 80° C. to evaporate the water therein, thereby achieving the purpose of concentration. The relative density of the final mixed concentrate is 1.05-1.5, and then add antelope horn powder (particle size of 10 μm) weighed according to the formula and mix well.

[0097] Example 7

[0098] The Chinese medicine compositions prepared in Examples 1-6 were respectively added with pharmaceutical excipients to prepare clinically acceptable capsules, granules, tablets, pills, powders and oral liquids.

[0099] Effect Example 1: Investigation of the Treatment of Atrial Fibrillation with Phlegm-Heat Internal Disturbance

[0100] Experimental animals: 6-week-old SPF male SD rats.

[0101] Experimental drugs: The Chinese medicine composition is that of Example 1.

[0102] Experimental methods:

[0103] Modeling: 36 normal male SD rats were adaptively raised for one week. The rats in the modeling group were injected with a mixed solution of acetylcholine (Ach) (66μg / mL)-calcium chloride (CaCl2) (10mg / mL) (0.1mL / l00g body weight / day, freshly prepared) through the tail vein to prepare the atrial fibrillation animal model, and the blank control group was injected with an equal volume of normal saline through the tail vein. The modeling was continued for 7 days, and the MP160 multi-channel physiological recorder was used to record the electrocardiogram. The modeling was successful when the electrocardiogram showed typical atrial fibrillation (Af) changes (disappearance of P wave, unequal RR interval, and appearance of small f wave).

[0104] Animal grouping and administration: The rats with successful modeling were divided into model group, low-dose group of Chinese medicine composition, medium-dose group of Chinese medicine composition, high-dose group of Chinese medicine composition, and amiodarone group (5.5 mg / ml, water-soluble amiodarone hydrochloride tablets) by the EXCEL random number table method, with 6 rats in each group. The Chinese medicine decoction was used, and the medicinal materials were purchased from Guang'anmen Hospital of China Academy of Chinese Medical Sciences. The raw drug amount after decoction and concentration was 0.7 g / ml, and the rat dosage was determined according to the "Standard Animal Dose Calculation Table" in "Pharmacological Experimental Methodology", that is, the rat equivalent dose was calculated according to the human-rat unit body weight conversion coefficient. Among them, the equivalent dose was used as the medium-dose group of the Chinese medicine composition, the high dose was 2 times the medium dose, and the low dose was 1 / 2 of the medium dose. The gavage volume was 1 mL / 100 g / d. The equivalent dose was used as the medium-dose group of the Chinese medicine composition (0.7 g / ml), and amiodarone hydrochloride tablets (5.5 mg / ml) were purchased from Sanofi (Hangzhou) Pharmaceutical Co., Ltd.

[0105] Observation indexes: 7 days after modeling and on the 28th day of drug administration, during the drug administration period, continue to inject acetylcholine (Ach) (66μg / mL)-calcium chloride (CaCl2) (10mg / mL) mixed solution daily, and record the electrocardiogram of each group of rats. Weigh, anesthetize with intraperitoneal injection of 2% sodium pentobarbital (0.33mL / 100g), fix the rats' limbs on the ECG monitoring platform, use Power Lab software to collect ECG, and inject drugs into the tail vein after the rats are quiet and the ECG is stable. The disappearance of P wave, unequal RR intervals, and the appearance of small f wave are the signs of AF occurrence, and the restoration of sinus rhythm, the disappearance of f wave, and the appearance of P wave are the termination of AF. The duration of AF (AF duration, AFD) is mainly recorded.

[0106] Experimental results: Before drug intervention (day 0), the electrocardiogram of rats was recorded. No AF occurred in the blank control group, but AF occurred in the modeling group, indicating that the modeling was successful. The electrocardiogram of rats in each group was recorded before and after the tail vein injection of Ach-CaCl2 for 28 days. The results are shown in Table 1 and Figure 1 As the number of experimental days increased, the AFD of the model group gradually prolonged. After 28 days of administration, compared with the model group, the AFD of each medication group was significantly shortened (P<0.01); the AFD of the high-dose Chinese medicine (QPH) group and the low-dose Chinese medicine (QPM) group was significantly shortened than that of the low-dose Chinese medicine (QPL) group (P<0.05). No significant differences were found in the rest (P>0.05).

[0107] Table 2 AFD results of rats in each group ( s)

[0108]

[0109]

[0110] Note: Compared with the model group,# P<0.05, ## P<0.01; compared with the high-dose Chinese medicine group, □ P<0.05; compared with the medium dose group of Chinese medicine, ▲ P<0.05; compared with the low-dose Chinese medicine group, ☆ P<0.05.

[0111] Clinical observation of the therapeutic effect of treating atrial fibrillation with phlegm-heat internal disturbance

[0112] Case 1

[0113] Mr. Li, male, 60 years old, retired worker, came to the clinic on April 12, 2019, mainly due to "intermittent palpitations for 3 years, aggravated by chest tightness for 2 weeks".

[0114] Current medical history: The patient had palpitations 3 years ago, and was diagnosed with atrial fibrillation by the local hospital. He was treated with oral medications such as Betaloc and Rivaroxaban. Two weeks ago, the palpitations became more severe than before, accompanied by obvious chest tightness and fatigue, which worsened after activity. He came to the clinic for further diagnosis and treatment.

[0115] Current symptoms: palpitations, chest tightness, fatigue, which is more obvious after activity, irritability, flushed face and heavy breathing, yellow sputum, excessive sputum or phlegm sound in the throat, irritability and insomnia, dry and bitter mouth, red urine and constipation, and physical fatigue.

[0116] Past medical history: history of hypertension for more than 10 years, with the highest blood pressure reaching 180 / 110mg. Currently taking amlodipine besylate 5mgpo qd and betaloc 47.5mgpo qd, controlled at around 140 / 90mg. Lacunar cerebral infarction for 2 years. Denied history of infectious diseases such as hepatitis and tuberculosis, denied history of surgery, trauma, and denied history of allergies to drugs, food, and other contacts.

[0117] The four diagnostic methods of traditional Chinese medicine are: clear consciousness, relaxed expression, normal body shape, relevant answers, high-pitched voice, red face, dark red tongue with yellow greasy coating, and slippery, rapid and intermittent pulse.

[0118] Auxiliary examination: Cardiac ultrasound: left atrium enlargement (LA: 46mm), left ventricular diastolic function decreased. Electrocardiogram: atrial fibrillation.

[0119] Western medicine diagnosis: 1. Atrial fibrillation; 2. Hypertension stage 3 (very high risk); 3. Lacunar cerebral infarction

[0120] TCM diagnosis: Palpitations (phlegm-heat internal disturbance syndrome)

[0121] Treatment principle: resolve phlegm and clear heat

[0122] Prescription: The Chinese medicine composition prepared in Example 1 (1 dose). 7 doses, decocted in water, 1 dose per day, once in the morning and evening half an hour after meals. Advise the patient to continue taking the original western medicine, avoid alcohol, keep a stable mood, and eat a light diet.

[0123] Second visit (April 19, 2019): Palpitations and fatigue symptoms were significantly relieved, expectoration decreased, mental state improved, dry mouth and bitterness decreased, red tongue decreased, yellow and slightly greasy fur, pulse stringy and slippery. Blood pressure 137 / 85mmHg. 7 doses were given, decocted in water, 1 dose per day, 1 time each in the morning and evening half an hour after meals.

[0124] Third visit (April 26, 2019): Palpitations and fatigue have basically disappeared, with occasional yellow sputum, and a more stable mood than before. The tongue is dark and slightly red, with a thin yellow fur, and a stringy and slippery pulse. Blood pressure is 127 / 84 mmHg. 14 doses were given, and the method of taking was the same as before. About 2 months later, a cardiac ultrasound was repeated, and the left atrium diameter was reduced (LA: 44 mm).

[0125] The patient in this case had atrial fibrillation and hypertension. He was easily excited. Over time, the five emotions turned into fire, burning the inside, and the liquid turned into phlegm. The phlegm and heat combined, disturbing the heart and causing palpitations and chest tightness. Fire easily generates wind, and heat also stirs up wind. When wind stirs up, the heart will not stop fibrillating. Therefore, the treatment is mainly to resolve phlegm and clear heat, and also to regulate qi and relieve chest tightness, calm wind and stop tremors. The syndrome and treatment are combined, so the effect is as good as a drum.

[0126] Case 2

[0127] Mr. Zhang, male, 58 years old, retired worker, came to the clinic on August 6, 2021 due to "intermittent palpitations for 2 years".

[0128] Current medical history: The patient developed palpitations after exertion 2 years ago, accompanied by dizziness and fatigue. The local hospital checked the electrocardiogram and found "atrial fibrillation", which was converted to sinus after treatment. After that, there were occasional atrial fibrillation, which could be converted by itself. Currently, the patient has 3-4 palpitations per week, which can be relieved by itself in about 6-8 hours. Regularly take sotalol 40mg bid for treatment. Come to the clinic for further diagnosis and treatment.

[0129] Current symptoms: palpitations, chest tightness, shortness of breath, fatigue, irritability, dry mouth and bitter taste, excessive yellow phlegm, thick and difficult phlegm, yellow urine, and uncomfortable bowel movements.

[0130] Past medical history: 15-year history of hypertension, with the highest blood pressure reaching 160 / 110mg. Currently taking amlodipine besylate 5mg poqd, the blood pressure is controlled at about 140 / 85mg. 3-year history of hyperlipidemia. Denies history of infectious diseases such as hepatitis and tuberculosis, surgery, trauma, and allergies to drugs, food, and other contacts.

[0131] The four diagnostic methods of traditional Chinese medicine: clear consciousness, relaxed expression, normal body shape, relevant answers, high-pitched voice, reddish complexion, dark purple lips, dark red tongue with yellow greasy coating, and slippery and rapid pulse.

[0132] Auxiliary examination: Cardiac ultrasound: left atrium enlargement (LA: 48mm), left ventricular diastolic function decreased. 24-hour electrocardiogram: 1. Sinus rhythm; 2. Paroxysmal atrial fibrillation (9 times in total).

[0133] Western medicine diagnosis: 1. Paroxysmal atrial fibrillation; 2. Hypertension stage 3 (very high risk); 3. Hyperlipidemia Traditional Chinese medicine diagnosis: Palpitations (phlegm-heat internal disturbance syndrome)

[0134] Treatment principle: resolve phlegm and clear heat

[0135] Prescription: The Chinese medicine composition prepared in Example 1 (1 dose). 7 doses, decocted in water, 1 dose per day, once in the morning and evening half an hour after meals. Advise the patient to continue taking antihypertensive drugs, maintain a stable mood, and eat a light diet.

[0136] Second visit (August 13, 2021): Palpitations occurred once within a week, lasting about 3 hours, shortness of breath and fatigue symptoms were alleviated, sputum was reduced, and dry mouth and bitterness were alleviated. Blood pressure was 135 / 82 mmHg. 14 doses were given, decocted in water, 1 dose per day, once in the morning and half an hour after meals.

[0137] Third visit (August 27, 2021): No more palpitations, significantly less expectoration, more stable mood, pale yellow urine, smooth bowel movements, slightly red tongue, thin yellow fur, and a stringy and slippery pulse. Blood pressure 127 / 80 mmHg. 14 doses were given, with the same method as before. A 24-hour dynamic electrocardiogram was also requested: sinus rhythm, occasional atrial premature beats, and occasional ventricular premature beats.

[0138] The patient in this case had atrial fibrillation combined with hypertension and hyperlipidemia. Due to long-term stressful and anxious working and living environment, his emotions were not smooth, the depression of wood generated fire, and the earth qi was overcome, the earth movement was disordered, and phlegm and dampness were generated internally. The heat and phlegm and dampness were internally entangled, burning each other, sticking inside, disturbing the heart and causing palpitations. Phlegm moves with the qi and does not stay in a fixed place. In addition, the liver yang wind moves and is erratic, so palpitations occur and stop. The treatment should focus on resolving phlegm and clearing heat, and also calming the wind and stopping tremors, regulating qi and unblocking collaterals. In this way, the prescription is based on the law, and the prescription corresponds to the syndrome.

[0139] Case 3

[0140] Yuan, male, 55 years old, retired teacher, came to the clinic on April 12, 2023 due to "intermittent palpitations for 3 years, aggravated for 1 month".

[0141] Current medical history: The patient had palpitations without obvious cause 3 years ago, but did not take it seriously. In 2021, the 24-hour dynamic electrocardiogram at the local hospital showed "persistent atrial fibrillation and frequent premature ventricular contractions". He was treated with oral treatment of 25mg qd of Betaloc and 110mg bid of Dabigatran. The symptoms still occurred from time to time, and the patient did not visit the doctor or take medicine regularly. One month ago, the patient's palpitations worsened and became more obvious after activities, so he came to the clinic for further diagnosis and treatment.

[0142] Current symptoms: palpitations, sometimes accompanied by chest tightness and pain, coughing up yellow sticky sputum, dry and bitter mouth, irritability and insomnia, yellow urine, and dry stool.

[0143] Past medical history: 10-year history of coronary heart disease, currently taking aspirin and atorvastatin calcium tablets regularly. Denies history of infectious diseases such as hepatitis and tuberculosis, denies history of surgery and trauma, denies history of allergies to drugs, food and other contacts.

[0144] The four diagnostic features of traditional Chinese medicine: clear consciousness, relaxed expression, normal body shape, relevant answers, reddish complexion, dark purple lips, dark red tongue with ecchymosis, yellow and greasy tongue coating, and a stringy, slippery pulse.

[0145] Western medicine diagnosis: 1. Atrial fibrillation; 2. Coronary atherosclerotic heart disease

[0146] TCM diagnosis: Palpitations (phlegm-heat internal disturbance syndrome)

[0147] Treatment principle: resolve phlegm and clear heat

[0148] Prescription: The Chinese medicine composition prepared in Example 1 (1 dose). 7 doses, decocted in water, 1 dose per day, once in the morning and evening half an hour after meals. Advise the patient to continue taking antihypertensive drugs, maintain a stable mood, and eat a light diet.

[0149] Second visit (April 19, 2023): Palpitations, chest tightness, chest pain were relieved, yellow sputum was reduced, and sleep improved. 14 doses were given, decocted in water, 1 dose per day, once in the morning and half an hour after meals.

[0150] Third visit (May 3, 2023): Palpitations were significantly relieved, chest tightness and pain did not recur, expectoration was significantly reduced, mood was stable, urine color became lighter, and bowel movements were regular. Continue to take 14 doses, the method of taking is the same as before. Recheck 24-hour dynamic electrocardiogram: persistent atrial fibrillation, occasional premature ventricular contractions.

[0151] The patient in this case is a patient with coronary heart disease and atrial fibrillation. He usually eats a lot of fatty and sweet food, which causes phlegm and dampness to block the meridians and blood circulation, resulting in blood stasis, which sticks to the heart with phlegm turbidity, and turns into heat, disturbing the heart, resulting in palpitations. Phlegm gathers in the lungs, and turns into heat after a long period of depression, resulting in cough and sputum, yellow sputum, yellow urine, dry stool, dark red tongue, and yellow and greasy tongue coating. The treatment should focus on resolving phlegm and clearing heat, and also on regulating qi and unblocking the meridians. Because the pathogenesis of this case is mainly due to phlegm causing blood stasis, the medication is mainly for resolving phlegm, especially Qingyanshi to remove stubborn phlegm, and Tianzhuhuang to clear phlegm and open the orifices.

[0152] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A Chinese medicine composition, characterized in that: Including the following raw materials: Qingyan stone, Tianzhuhuang, Nardostachys grandiflora, cicada shell, whole Trichosanthes, Coptis chinensis, antelope horn powder and Corydalis yanhusuo.

2. The Chinese medicine composition according to claim 1, characterized in that: The raw materials include the following parts by weight: 10-30 parts by weight of qingyanshi, 3-9 parts by weight of dianthus, 9-15 parts by weight of nardostachys grandiflora, 9-15 parts by weight of cicada shells, 10-30 parts by weight of whole trichosanthes, 3-9 parts by weight of coptis root, 0.2-0.5 parts by weight of antelope horn powder and 9-15 parts by weight of yanhusuo.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: The raw materials include the following parts by weight: 15 parts by weight of qinglanshi, 6 parts by weight of dianthus, 12 parts by weight of nardostachys grandiflora, 12 parts by weight of cicada shells, 15 parts by weight of whole trichosanthes, 6 parts by weight of coptis root, 0.3 parts by weight of antelope horn powder and 12 parts by weight of yanhusuo.

4. A method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The steps include: S1. Weighing greenstone according to the formula, extracting to obtain an extract; S2, according to the formula, weighed Radix Glehniae, Rhizoma Nardostachys, Periostracum Cicadae, Fructus Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis, mixed, then added the extract in step S1, then extracted, filtered, and obtained extract 1 and medicinal residues; S3, extracting and filtering the medicinal residue in step S2 to obtain an extract 2 and medicinal residue; S4. Combine extract 1 and extract 2 to obtain a mixed extract, concentrate it, and then add antelope horn powder weighed according to the formula.

5. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: In step S1, the extraction conditions are as follows: water is added to the greenstone, the weight ratio of the added water to the greenstone is (1-15):1, the decoction temperature is 60-100°C, and the decoction time is 0.5-1h.

6. The method for preparing the Chinese medicine composition according to claim 4 or 5, characterized in that: In step S2, the extraction is performed by heating water extraction; Optionally, in step S2, the temperature of the heated water extraction is 60-100°C, the heating extraction time is 1-5h / time, and the number of extractions is 1-5 times; preferably, the heating extraction time is 2-5h / time; Optionally, in step S2, the temperature of the heated water extraction is 80-100°C; Optionally, in step S2, according to the formula, Radix Glechomae Dahuricae, Rhizoma Nardostachys, Periostracum Cicadae, Fructus Trichosanthis, Rhizoma Coptidis and Rhizoma Corydalis are weighed and mixed to obtain a mixed raw material, firstly added with water for soaking, the weight of the added water being in a ratio of (1-15):1 to the weight of the mixed raw material, and then soaked for 20-90 min; preferably, the soaking time is 30-60 min, more preferably 30 min; Optionally, in step S2, the ratio of the weight of the added water to the weight of the mixed raw materials is (5-15):1, more preferably (6-12):1, and even more preferably (6-8):

1.

7. The method for preparing the Chinese medicine composition according to any one of claims 4 to 6, characterized in that: In step S3, the extraction is performed by heating water extraction; Optionally, in step S3, the temperature of the heated water extraction is 60-100°C, the heating extraction time is 1-5h / time, and the number of extractions is 1-5 times; preferably, the heating extraction time is 1-3h / time; Optionally, in step S3, the temperature of the heated water extraction is 80-100°C; Optionally, in step S3, the ratio of the weight of the added water to the weight of the medicinal residue in step S2 is (1-15):1; preferably, the ratio of the weight of the added water to the weight of the medicinal residue in step S2 is (6-8):1, and further preferably is 6:

1.

8. The method for preparing the Chinese medicine composition according to any one of claims 4 to 7, characterized in that: In step S4, the mixed extract is concentrated by reduced pressure evaporation under vacuum, the concentration temperature is 80-100° C., and the relative pressure during concentration is -0.05 to -0.1 MPa; Optionally, in step S4, the concentration temperature is 80° C., and the relative pressure during concentration is -0.05 to -0.095 MPa; preferably, the relative pressure during concentration is -0.07 MPa; Optionally, in step S4, the mixed extract is subjected to heating evaporation treatment at normal pressure, and the mixed extract is heated at an absolute pressure of 1 atm, and the heating temperature is 80-100° C.; Optionally, in step S4, the relative density of the mixed concentrated solution obtained in the concentration step is 1.05-1.5, preferably 1.1-1.5, and more preferably 1.1-1.3; In step S4, the particle size of the antelope horn powder is ≤15 μm; preferably, 1-15 μm; and more preferably, 10-15 μm.

9. A Chinese medicine preparation, characterized in that: The Chinese medicine composition comprising any one of claims 1 to 3 or the Chinese medicine composition prepared by the method for preparing the Chinese medicine composition according to any one of claims 4 to 8 as an active ingredient, with or without the addition of pharmaceutical excipients, to prepare a clinically acceptable dosage form; Optionally, the dosage form includes capsules, tablets, granules, pills, powders or oral liquids; Optionally, the pharmaceutical excipients include but are not limited to starch, dextrin, lactose, microcrystalline cellulose, gelatin, sucrose or magnesium stearate.

10. Use of the Chinese medicine composition according to any one of claims 1 to 3, the Chinese medicine composition prepared by the method for preparing the Chinese medicine composition according to any one of claims 4 to 8, or the Chinese medicine preparation according to claim 9 in preparing drugs and / or health products for treating atrial fibrillation; Optionally, the atrial fibrillation is atrial fibrillation caused by phlegm-heat internal disturbance.