Traditional Chinese medicine composition for treating paroxysmal atrial fibrillation, preparation method, application and medicine

Abstract

The invention provides a traditional Chinese medicine composition for treating paroxysmal atrial fibrillation, a preparation method, application and a medicine, and belongs to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition is prepared from 10-30 parts of lignum dalbergiae odoriferae, 5-15 parts of lignum santali albi, 3-6 parts of agilawood, 20-60 parts of radix astragali, 3-9 parts of cortex periplocae, 5-15 parts of radix saposhnikoviae, 10-30 parts of pine nodular branch, 5-15 parts of fructus mume and 3-10 parts of radix sophorae flavescentis. The composition medicine for relieving palpitation, chest distress, shortness of breath, fatigue and weakness, anxiety and depression and insomnia of a patient is created, multiple medicines are combined to jointly achieve the effects of regulating qi, promoting blood circulation, calming the heart, soothing the nerves and relieving palpitation, clinical uncomfortable symptoms of the patient are improved, the transfer rate is increased, the atrial fibrillation attack frequency and duration are reduced, the atrial fibrillation load and the ventricular rate are reduced, and the traditional Chinese medicine syndrome points are improved; the occurrence risk of cerebral apoplexy and heart failure complications is prevented; the traditional Chinese medicine composition has a good curative effect on paroxysmal atrial fibrillation with qi stagnation, blood stasis and restlessness as main pathogenesis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and relates to a pharmaceutical composition for treating paroxysmal atrial fibrillation, and specifically, relates to a traditional Chinese medicine composition for treating paroxysmal atrial fibrillation, a preparation method, an application and a medicine. Background Art

[0002] Paroxysmal atrial fibrillation (POAF) is a common clinical tachyarrhythmia. The main symptoms of patients are palpitations, chest tightness, shortness of breath, fatigue, dizziness, insomnia, anxiety and depression. It can convert to sinus rhythm within 7 days. The attack time is usually ≤48h, with the characteristics of sudden onset and sudden cessation, and irregular onset.

[0003] The prevalence of atrial fibrillation in adults is about 2%-4%, with a tendency to increase with age. The prevalence in people over 80 years old is as high as 10%, and the prevalence in people 85 years and above is as high as 17.4%. If paroxysmal atrial fibrillation is not properly prevented and treated, it can progress to persistent atrial fibrillation, which is one of the common diseases that cause arrhythmia, stroke, heart failure, and even fatal myocardial embolism in clinical practice. The risk of complications of heart failure is three times that of normal people, the incidence of stroke is as high as 24.8%, and the mortality rate and disability rate are about 20% and 60%, respectively. Atrial fibrillation can cause a 2-fold increase in all-cause mortality in women and a 1.5-fold increase in men. Paroxysmal atrial fibrillation has the same risk of ischemic stroke as persistent atrial fibrillation. At the same time, paroxysmal atrial fibrillation can cause heart enlargement, increased myocardial load, decreased cardiac function, atrial thrombosis, and even fatal myocardial embolism, which imposes a significant burden on patients, social health, and health economy.

[0004] There are many problems with current Western medicine treatment plans, such as the bleeding risk of anticoagulants, arrhythmia and extracardiac toxicity of antiarrhythmic drugs, and high recurrence rate of radiofrequency ablation. Studies have found that the overall success rate of atrial fibrillation ablation is only 60%, and patients with early postoperative atrial fibrillation recurrence are more likely to have late recurrence, with a recurrence rate of 60% for paroxysmal atrial fibrillation and 81% for persistent atrial fibrillation, and a complication rate of 5.3%. Therefore, in recent years, seeking drugs with good efficacy and few side effects to treat paroxysmal atrial fibrillation has become the focus of traditional Chinese medicine research.

[0005] Paroxysmal atrial fibrillation belongs to the category of "heart palpitations" in traditional Chinese medicine. For example, Zhao Guangzhen reviewed the traditional Chinese medicine's understanding of the pathogenesis, etiology, and dialectical treatment methods of palpitations and palpitations in the article "A Brief Introduction to Traditional Chinese Medicine Treatment of Heart Palpitations". While traditional Chinese medicine treats paroxysmal atrial fibrillation with standardized treatment, it also focuses on the holistic concept and individualized dialectical treatment, which has the advantage of making up for the shortcomings of Western medicine treatment plans.

[0006] Chinese invention patent CN116211940A discloses a Chinese medicine composition for treating paroxysmal atrial fibrillation, which comprises 9-15 parts of Dalbergia odorifera, 1-5 parts of Aquilaria sinensis, 10-15 parts of Salvia miltiorrhiza, 5-10 parts of Pheretima chinensis, 3-10 parts of Platycladus orientalis, 10-25 parts of Mother of Pearl, 9-15 parts of Pinus tabulaeformis, 9-30 parts of Astragalus, and 3-6 parts of Perennial Cortex. However, in recent clinical applications, the inventors found that the Chinese medicine composition of the prior art is prone to cause diarrhea in some patients, with a probability of about 30%, and the prior art has not yet provided a Chinese medicine composition for treating paroxysmal atrial fibrillation with better efficacy and fewer side effects. Summary of the invention

[0007] To solve the above problems, the present invention provides a Chinese medicine composition, preparation method, application and medicine for treating paroxysmal atrial fibrillation. On the basis of the existing technology, the inventor re-established the formula compatibility, removed the bitter, cold and slippery products such as salvia miltiorrhiza, cypress seed and earthworm that are easy to cause diarrhea, added sandalwood, dalbergia odorifera and agarwood to promote qi and blood circulation to regulate blood vessels and stop tremors, added bitter and dry bitterness to the sour and astringent black plum to astringe body fluids, remove dampness and stop diarrhea, based on the theory of "wind can overcome dampness", took the wind-removing and dampness-removing properties of siler and pine knot, firstly, dispelling wind and stopping tremors, secondly, removing dampness and stopping diarrhea, achieving the functions of regulating mind and pulse, improving atrial fibrillation and alleviating diarrhea, and obtaining a Chinese medicine composition with better treatment effect and fewer side effects.

[0008] In order to achieve the above-mentioned purpose of the invention, on the one hand, the present invention provides a traditional Chinese medicine composition for treating paroxysmal atrial fibrillation, which is composed of the following ingredients by weight: 10-30 parts of Dalbergia odorifera, 5-15 parts of Santalum album, 3-6 parts of Aquilaria wood, 20-60 parts of Astragalus membranaceus, 3-10 parts of Perennial Herb, 5-15 parts of Saposhnikovia divaricata, 10-30 parts of Pinus tabulaeformis, 5-15 parts of Eume and 3-10 parts of Sophora flavescens.

[0009] Preferably, the Chinese medicine composition consists of the following ingredients by weight: 15 parts of Dalbergia odorifera, 5-10 parts of Santalum album, 3-6 parts of Aquilaria wood, 20-50 parts of Astragalus membranaceus, 3-6 parts of Perennial Herb, 5-15 parts of Saposhnikovia divaricata, 10-15 parts of Pinus tabulaeformis, 5-15 parts of Eume and 3-10 parts of Sophora flavescens.

[0010] As one embodiment of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 5 parts of Santalum album, 3 parts of Aquilaria wood, 30 parts of Astragalus membranaceus, 3 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 10 parts of Prunus mume and 5 parts of Sophora flavescens.

[0011] As one scheme of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 5 parts of Santalum album, 3 parts of Aquilaria wood, 20 parts of Astragalus membranaceus, 3 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 10 parts of Pinus tabulaeformis, 5 parts of Prunus mume and 3 parts of Sophora flavescens.

[0012] As one scheme of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 3 parts of Aquilaria wood, 20 parts of Astragalus membranaceus, 3 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 10 parts of Pinus tabulaeformis, 5 parts of Prunus mume and 3 parts of Sophora flavescens.

[0013] As one scheme of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria wood, 20 parts of Astragalus membranaceus, 3 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 10 parts of Pinus tabulaeformis, 5 parts of Prunus mume and 3 parts of Sophora flavescens.

[0014] As one scheme of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria wood, 20 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 10 parts of Pinus tabulaeformis, 15 parts of Prunus mume and 3 parts of Sophora flavescens.

[0015] As one embodiment of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria wood, 20 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 5 parts of Prunus mume and 3 parts of Sophora flavescens.

[0016] As one scheme of the present invention, the Chinese medicine composition consists of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria woods, 40 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 5 parts of Ebony plum and 3 parts of Sophora flavescens.

[0017] As one scheme of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria wood, 40 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 10 parts of Prunus mume and 10 parts of Sophora flavescens.

[0018] As one embodiment of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria wood, 40 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 15 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 15 parts of Prunus mume and 10 parts of Sophora flavescens.

[0019] As one scheme of the present invention, the Chinese medicine composition consists of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 3 parts of Aquilaria wood, 30 parts of Astragalus membranaceus, 3 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 5 parts of Eume and 5 parts of Sophora flavescens.

[0020] As one embodiment of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria wood, 30 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 10 parts of Saposhnikovia divaricata, 10 parts of Pinus tabulaeformis, 10 parts of Prunus mume and 10 parts of Sophora flavescens.

[0021] As one scheme of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria wood, 20 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 10 parts of Saposhnikovia divaricata, 10 parts of Pinus tabulaeformis, 10 parts of Prunus mume and 10 parts of Sophora flavescens.

[0022] As one scheme of the present invention, the Chinese medicine composition is composed of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 6 parts of Aquilaria wood, 50 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 10 parts of Saposhnikovia divaricata, 10 parts of Pinus tabulaeformis, 10 parts of Prunus mume and 10 parts of Sophora flavescens.

[0023] As a preferred embodiment of the present invention, the Chinese medicine composition consists of the following ingredients by weight: 15 parts of Dalbergia odorifera, 5 parts of Santalum album, 3 parts of Aquilaria wood, 60 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 10 parts of Prunus mume and 5 parts of Sophora flavescens.

[0024] As a preferred embodiment of the present invention, the Chinese medicine composition consists of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 3 parts of Aquilaria wood, 30 parts of Astragalus membranaceus, 3 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 5 parts of Ebony plum and 5 parts of Sophora flavescens.

[0025] Preferably, the astragalus is raw astragalus.

[0026] The properties, flavors, meridians and effects of the components used in the Chinese medicine composition of the present invention are as follows:

[0027] Dalbergia odorifera: pungent; warm; non-toxic. It enters the heart, liver, spleen, and lung meridians. It can promote blood circulation and dissipate blood stasis, stop bleeding and relieve pain, lower qi, and dispel filth. It is mainly used to treat chest and flank pain, traumatic injuries, traumatic bleeding, as well as vomiting and abdominal pain caused by cold hernia or internal obstruction of filth. It can improve myocardial remodeling, improve myocardial function, and lower blood pressure; it can significantly inhibit thrombosis and anti-platelet activity; it can inhibit the central nervous system, and the volatile oil can relieve depression.

[0028] Sandalwood: pungent; warm in nature. Enters the spleen, stomach, and lung meridians. Promotes qi, dissipates blood stasis, and relieves pain. Indications: chest and abdominal pain, cholera vomiting and diarrhea, choking and vomiting, cold hernia abdominal pain, and swelling. It has sedative and soothing effects, improves sleep, relieves anxiety, is diuretic, and resists acute myocardial ischemia and hypoxia.

[0029] Agarwood: pungent, bitter, warm. It enters the heart, spleen, stomach, and kidney meridians. It promotes qi circulation and relieves pain, lowers adverse qi and regulates the middle, warms the kidney and absorbs qi. It is used for symptoms of cold stagnation and qi stagnation, chest and abdominal distension and pain; stomach cold vomiting, hiccups, etc.; asthma caused by coldness in the lower abdomen and kidney failure to absorb qi, as well as cough and asthma caused by phlegm and fluid, and symptoms of upper excess and lower deficiency. It has the effects of calming the mind, relieving pain, anti-depression, increasing sleep speed and prolonging sleep time, inhibiting gastrointestinal tension spasm, improving myocardial damage, and anti-oxidation, antibacterial, and anti-inflammatory.

[0030] Raw Astragalus: sweet, slightly warm. Enters the spleen and lung meridians. It has the effects of replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting fluid and nourishing blood, relieving stagnation and relieving arthritis, expelling toxins and draining pus, and astringing sores and promoting tissue regeneration. It is suitable for spleen qi deficiency syndrome, lung qi deficiency syndrome, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, chlorosis due to blood deficiency, thirst, hemiplegia, pain and numbness, etc. Modern pharmacological studies have shown that the total astragaloside contained in Astragalus can effectively improve the cardiac function of rats with heart failure and reverse ventricular remodeling.

[0031] Perennial Cortex: pungent, bitter, warm; toxic. Enters the liver, kidney, and heart meridians. Has the effects of promoting diuresis and reducing swelling, removing rheumatism, and strengthening tendons and bones. Suitable for edema, dysuria, wind-cold-dampness arthralgia, soreness of waist and knees, etc. Modern pharmacological studies have shown that Perennial Cortex contains cardiac glycoside compounds, which have similar effects to digoxin and can increase cardiac ejection fraction.

[0032] Saposhnikovia root: pungent, sweet, slightly warm in nature. Enters the bladder, lung, spleen, and liver meridians. Expels wind and relieves exterior symptoms, overcomes dampness and relieves pain, relieves spasms, and relieves itching. Indications: exogenous wind-cold; headache and body pain; rheumatism and pain; joint pain; abdominal pain and diarrhea; intestinal wind and blood; tetanus; urticaria and itching; early stage of sores. Has anticoagulant, analgesic, sedative, and anti-allergic effects.

[0033] Turpentine: bitter, warm. Enters the liver and kidney meridians. Has the effects of dispelling wind and dampness, dredge meridians and collaterals, and promote blood circulation and relieve pain. It is mainly used to treat wind-cold-damp arthralgia, rheumatism and pain in the joints, numbness and weakness of the feet, and pain caused by falls. Modern pharmacological studies have shown that turpentine has an inhibitory effect on xanthine oxidase, can relieve gout, and has anti-inflammatory, antiviral, anti-tumor and anti-cancer effects.

[0034] Wumei: sour in taste; neutral in nature. Enters the liver, spleen, lung, kidney, stomach, and large intestine meridians. It can astringe the lungs and stop cough, astringe the intestines and stop diarrhea, stop bleeding, promote the production of body fluids, and calm ascaris. It is used to treat chronic cough, thirst due to deficiency heat, chronic malaria, chronic diarrhea, dysentery, blood in stool, blood in urine, metrorrhagia, abdominal pain due to ascaris, vomiting, and hookworm disease. It has the effects of lowering blood lipids and blood sugar, improving insulin sensitivity, calming, anticonvulsant, and regulating intestinal flora.

[0035] Sophora flavescens: bitter in taste; cold in nature. Targets the heart, liver, kidney, large intestine, small intestine, and bladder meridians. Clears away heat and dries dampness, dispels wind and kills insects. Indications: diarrhea due to damp heat; blood in the stool due to intestinal wind; jaundice; dysuria; edema; leucorrhea; vulvar itching; scabies; leprosy; skin itching; dampness and poison sores. Antagonizes various types of arrhythmias such as atrial fibrillation, atrial flutter, and ventricular fibrillation, protects against myocardial damage, improves cardiac function and inhibits ventricular remodeling, relieves heart failure, improves anxiety and depression, and reduces transaminase.

[0036] The compatibility significance of the Chinese medicine composition: The Chinese medicine composition of the present invention takes "pulse and spirit coordination" as the basic concept, and uses cassia bark as the main medicine to regulate blood vessels. Its temperature is warm, and it is endowed with the wood energy of spring and harmony. Its color is red, and it goes to the south to regulate blood and enters the Jueyin meridian. "Depei Materia Medica" says that it "enters the blood and lowers the qi, treats anger and stops bleeding"; sandalwood and agarwood are the ministers. Sandalwood is yellow in color, goes to the middle burner and regulates the spleen, and agarwood is heavy in nature, which can raise and lower various qi. The three medicines are used together, and the main and minister compatibility can regulate blood and qi, so that blood The pulse is naturally calm; atrial fibrillation is an abnormal heartbeat, which is most likely to consume the heart's qi, so astragalus and cyperus rotundus are used as medicine. Astragalus is a holy medicine for replenishing qi, and cyperus rotundus strengthens the heart and promotes diuresis. The combination of the two medicines can help the heart qi and promote diuresis, and also has the effect of regulating the pulse; the nature of atrial fibrillation is like the movement of the wind, so it should be supplemented with wind-extinguishing products, turpentine and saposhnikovia divaricata. The ancients said that turpentine "mainly treats long-term wind in all joints, wind deficiency, and pain in the feet", and saposhnikovia divaricata is pungent and warm and moves to the lungs. "Leigong's Explanation of the Properties of Medicinal Materials" says that "it is a yang-raising agent, so it can treat all kinds of wind". Wumei is sour and flat in taste, mainly produces body fluids and relieves irritability and heat, bitter in the heart, cold and fire, specializes in treating the fire of the heart meridian, the two medicines are combined to nourish yin and clear heat, and the evil heat is removed, then the mind is at peace, and the two medicines are used together to play the role of regulating the mind. The main combination is that yin and yang go together, cold and heat are balanced, and the pulse and spirit are nourished, then atrial fibrillation will stop.

[0037] On the other hand, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: mixing a formula amount of dalbergia odorifera, sandalwood, agarwood, astragalus, angelica sinensis bark, siler, pine knot, ebony and sophora flavescens.

[0038] In yet another aspect, the present invention provides use of the above-mentioned Chinese medicine composition and the Chinese medicine composition prepared by the above-mentioned preparation method in preparing a drug for treating paroxysmal atrial fibrillation.

[0039] Preferably, the paroxysmal atrial fibrillation is paroxysmal atrial fibrillation of the qi stagnation and blood stasis type.

[0040] In yet another aspect, the present invention provides a medicine comprising the above-mentioned Chinese medicine composition and / or the Chinese medicine composition prepared by the above-mentioned preparation method.

[0041] The drug can be prepared into dosage forms such as pills, capsules, granules, oral liquids, powders, tablets, lozenges, and lozenges, and suitable drug carriers in the art can be selected for different dosage forms.

[0042] The pharmaceutical carrier used can be solid or liquid. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water.

[0043] When preparing the composition for oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agent, preservative, coloring agent, etc. can be used to form oral liquid preparations, such as suspensions, elixirs and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, disintegrants can be used to form oral solid preparations, such as powders, capsules and tablets. Tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0044] Tablets containing the Chinese medicine composition of the present invention can be prepared by tableting or molding, and one or more auxiliary ingredients or adjuvants can be used. The active ingredient can be tableted in a free-flowing form (such as powder or granules) in a suitable machine, and can be mixed with an adhesive, a lubricant, an inert diluent, a surfactant or a dispersant to prepare a tablet. Molded tablets can be molded in a suitable machine, i.e., a powdered compound mixture moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active drug, mixed with an appropriate and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of active ingredient, usually 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0045] In addition to the above-mentioned carrier components, the above-mentioned pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, adhesives, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants and flavoring agents, etc., may be added. The preparation is made isotonic with the blood of the intended recipient. The components containing the Chinese medicine composition of the present invention can also be prepared in the form of powder or concentrate.

[0046] Preferably, the medicament further comprises a pharmaceutically acceptable excipient.

[0047] Preferably, the dosage form of the drug includes paste prescription, decoction, pill, powder, capsule or tablet.

[0048] As an example of the present invention, the dosage form of the drug is a decoction.

[0049] Specifically, the preparation method of the decoction comprises the following steps:

[0050] Mix the formulated raw material with water, decoct for 3 times, combine the decoctions, and filter to obtain the product.

[0051] As an example of the present invention, the dosage form of the drug is powder.

[0052] Specifically, the preparation method of the powder comprises the following steps:

[0053] The formulated raw materials are mixed and ground into powder to obtain a powder.

[0054] More preferably, the powder is dried before being ground.

[0055] More preferably, the drug powder is 60-100 mesh.

[0056] As an example of the present invention, the dosage form of the drug is a pill.

[0057] Preferably, the pills are selected from water pills, paste pills or honey pills.

[0058] Specifically, the preparation method of the water pill comprises the following steps:

[0059] The raw materials in the formula amount are mixed and ground into powder, mixed with water, and molded into water-filled pills.

[0060] More preferably, the powder is dried before being ground.

[0061] More preferably, the drug powder is 60-100 mesh.

[0062] Specifically, the preparation method of the paste pills comprises the following steps:

[0063] The raw materials in the formula amount are mixed and ground into powder, and then the paste-like auxiliary materials are added and mixed evenly, and the mixture is formed into paste pills.

[0064] More preferably, the powder is dried before being ground.

[0065] More preferably, the drug powder is 60-100 mesh.

[0066] More preferably, the paste-like auxiliary material is selected from at least one of starch paste and rice paste.

[0067] Specifically, the preparation method of the honey pill comprises the following steps:

[0068] The raw materials in the formula amount are mixed and ground to obtain the medicine powder, and the medicine powder is evenly mixed with honey, and molded to obtain honey pills.

[0069] More preferably, the powder is dried before being ground.

[0070] More preferably, the drug powder is 60-100 mesh.

[0071] More preferably, the weight ratio of the medicinal powder to the honey is 1:1-1.5.

[0072] More preferably, before the medicinal powder is mixed with honey, the honey is boiled to a medium honey.

[0073] Compared with the prior art, the beneficial effects of the present invention include:

[0074] (1) The compatibility of the Chinese medicine composition of the present invention is based on the theoretical connotation of "heart governs blood vessels", "heart governs spirit" and "blood vessels are harmonious and healthy, spirit is at home", and believes that the pathogenesis of paroxysmal atrial fibrillation is "blood vessels are not smooth, spirit is not at home", and innovatively proposes the general treatment principle of "pulse and spirit are in harmony", and treats paroxysmal atrial fibrillation with qi stagnation and blood stasis and restlessness as the main pathogenesis. Blood vessels are not smooth, the mind is not nourished, the spirit is not at home, floating outside, palpitations and restlessness; spirit is not in control, viscera function is disordered, qi and blood circulation is disordered, and veins are damaged, which is more likely to aggravate the mechanism of blood vessels being not smooth, so a vicious cycle occurs, and palpitations occur from time to time. The treatment of paroxysmal atrial fibrillation from the perspective of regulating pulse mainly focuses on regulating qi and activating blood circulation, removing blood stasis and unblocking pulses, and the treatment of paroxysmal atrial fibrillation from the perspective of regulating spirit mainly focuses on calming the mind. Pulse is a tangible body, and spirit is an intangible function. Regulating pulse is to establish the foundation, and calming the mind is to correct the master, so that the pulse is regulated and the mind is calm, and palpitations stop.

[0075] (2) Animal experiments show that the Chinese medicine composition provided by the present invention can reduce the gene and protein expression of ADRB1, Cav1.2, PKA and RyR2, regulate calcium channels, promote calcium homeostasis, and thus treat paroxysmal atrial fibrillation.

[0076] (3) Human experiments show that the Chinese medicine composition provided by the present invention can effectively improve the therapeutic effect of paroxysmal atrial fibrillation of qi stagnation and blood stasis type, while reducing the side effect of diarrhea.

[0077] (4) Human experiments show that the Chinese medicine composition provided by the present invention has no obvious toxic side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0078] Figure 1 is a bar graph of relative expression of target genes in atrial tissue of rats in each group; among them, A is a bar graph of relative expression of ADRB1 gene in each group, B is a bar graph of relative expression of PKA gene in each group, C is a bar graph of relative expression of Cav1.2 gene in each group, and D is a bar graph of relative expression of RyR2 gene in each group; compared with the blank group, *P<0.05, **P<0.01; compared with the model group, △ P<0.05, △△ P<0.01.

[0079] Figure 2 These are the protein imprints of the expression of atrial muscle tissue-related proteins in each group of rats, among which A is the protein imprint of ADRB1, B is the protein imprint of PKA, C is the protein imprint of Cav1.2, and D is the protein imprint of RyR2.

[0080] Figure 3 The relative expression bar graphs of atrial muscle tissue-related proteins in each group of rats, among which A is the relative expression bar graph of ADRB1 protein, B is the relative expression bar graph of PKA protein, C is the relative expression bar graph of Cav1.2 protein, and D is the relative expression bar graph of RyR2 protein; compared with the blank group, *P<0.05, **P<0.01; compared with the model group, △ P<0.05, △△ P<0.01. DETAILED DESCRIPTION

[0081] The present invention is further described in detail below in conjunction with specific embodiments, and the advantages and features of the present invention will become clearer as the description proceeds. However, these embodiments are exemplary only and do not constitute any limitation to the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.

[0082] Example 1

[0083] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0084] 15g of Dalbergia odorifera, 5g of sandalwood, 3g of agarwood, 30g of raw Astragalus, 3g of Cyperus rotundus, 5g of Saposhnikovia divaricata, 15g of Pinus tabulaeformis, 10g of Prunus mume, and 5g of Sophora flavescens.

[0085] Preparation method: Mix the above raw materials together, put them in a casserole, add water to cover the surface of the medicine, soak for 20-30 minutes, then decoct with low heat, continue to decoct for 30 minutes after boiling, decoct three times in total, combine the three decoctions and filter to obtain a decoction.

[0086] Directions for use: Decoction, one dose per day, decocted in water and taken once in the morning and evening, one course of treatment is 28 days.

[0087] Example 2

[0088] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0089] 15g of Dalbergia odorifera, 5g of sandalwood, 3g of agarwood, 20g of raw Astragalus, 3g of Cyperus rotundus, 5g of Saposhnikovia divaricata, 10g of Pinus tabulaeformis, 5g of Ebony plum, and 3g of Sophora flavescens.

[0090] The preparation method and instructions for use are consistent with those of Example 1.

[0091] Example 3

[0092] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0093] 15g of Dalbergia wood, 10g of sandalwood, 3g of agarwood, 20g of raw Astragalus, 3g of Cyperus rotundus, 5g of Saposhnikovia divaricata, 10g of Pinus tabulaeformis, 5g of Ebony plum, and 3g of Sophora flavescens.

[0094] The preparation method and instructions for use are consistent with those of Example 1.

[0095] Example 4

[0096] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0097] Dalbergia odorifera 15g, sandalwood 10g, agarwood 6g, raw astragalus 20g, Perilla frutescens bark 3g, Saposhnikovia divaricata 5g, Chinese pine knot 10g, black plum 5g, Sophora flavescens 3g. The preparation method and use instructions are the same as those in Example 1.

[0098] Example 5

[0099] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0100] Dalbergia woodensis 15g, sandalwood 10g, agarwood 6g, raw astragalus 20g, Cyperus rotundus bark 6g, Saposhnikovia divaricata 5g, pine knot 10g, ebony 5g, Sophora flavescens 3g.

[0101] Preparation method:

[0102] (1) Mixing the above-mentioned raw materials together;

[0103] (2) drying the above Chinese medicinal components and grinding them into powder, wherein the medicinal powder has a mesh size of 60-100;

[0104] (3) Packaging the drug powder to obtain a powder.

[0105] Example 6

[0106] A traditional Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw materials of which are as follows: 15g of dalbergia odorifera, 10g of santalin, 6g of agarwood, 20g of raw astragalus, 6g of angelica sinensis bark, 5g of siler, 15g of tabulaeformis, 5g of ebony, and 3g of sophora flavescens.

[0107] Preparation method:

[0108] (1) Mixing the above-mentioned raw materials together;

[0109] (2) drying the above Chinese medicinal components and grinding them into powder, wherein the medicinal powder has a mesh size of 60-100;

[0110] (3) Add appropriate amount of water to the drug powder;

[0111] (4) After mixing, the mixture is formed manually or by machine to obtain water-soluble pills.

[0112] Example 7

[0113] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0114] Dalbergia odorifera 15g, sandalwood 10g, agarwood 6g, raw astragalus 40g, Cyperus rotundus bark 6g, Saposhnikovia divaricata 5g, pine knot 15g, ebony 5g, Sophora flavescens 3g.

[0115] Preparation method:

[0116] (1) Mixing the above-mentioned raw materials together;

[0117] (2) drying the above Chinese medicinal components and grinding them into powder, wherein the medicinal powder has a mesh size of 60-100;

[0118] (3) Adding an appropriate amount of starch paste or rice paste to the drug powder;

[0119] (4) After mixing, the mixture is formed into pills by hand or machine.

[0120] Example 8

[0121] A traditional Chinese medicine composition for treating paroxysmal atrial fibrillation, wherein the raw materials are as follows: 15g of dalbergia odorifera, 10g of santalin, 6g of agarwood, 40g of raw astragalus, 6g of angelica sinensis bark, 5g of siler, 15g of tabulaeformis, 10g of ebony root, and 10g of sophora flavescens.

[0122] Preparation method:

[0123] (1) Mixing the above-mentioned raw materials together;

[0124] (2) drying the above Chinese medicinal components and grinding them into powder, wherein the medicinal powder has a mesh size of 80-100;

[0125] (3) granulating the drug powder and drying it;

[0126] (4) The granules are filled into capsules by machine to obtain capsules.

[0127] Example 9

[0128] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0129] 15g of Dalbergia odorifera, 10g of sandalwood, 6g of agarwood, 30g of raw Astragalus, 6g of Cyperus rotundus, 15g of Saposhnikovia divaricata, 15g of Pinus tabulaeformis, 15g of Prunus mume, and 10g of Sophora flavescens.

[0130] Preparation method:

[0131] (1) Mixing the above-mentioned raw materials together;

[0132] (2) drying the above Chinese medicinal components and grinding them into powder, wherein the medicinal powder has a mesh size of 60-100;

[0133] (3) Weigh honey in a ratio of 1:1-1.5 to the weight of the medicinal powder, and boil the honey until it is medium-melted;

[0134] (4) After mixing the medicinal powder and the medium honey, shape them manually or by machine to obtain honey pills.

[0135] Example 10

[0136] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0137] 15g of Dalbergia wood, 10g of sandalwood, 6g of agarwood, 30g of raw Astragalus, 6g of Cyperus rotundus, 10g of Saposhnikovia divaricata, 10g of Pinus tabulaeformis, 10g of Prunus mume, and 10g of Sophora flavescens.

[0138] The preparation method and instructions for use are consistent with those of Example 1.

[0139] Embodiment 11

[0140] 15g of Dalbergia wood, 10g of sandalwood, 6g of agarwood, 20g of raw Astragalus, 6g of Cyperus rotundus, 10g of Saposhnikovia divaricata, 10g of Pinus tabulaeformis, 10g of Ebony plum, and 10g of Sophora flavescens.

[0141] The preparation method and instructions for use are consistent with those of Example 1.

[0142] Example 12

[0143] 15g of Dalbergia wood, 10g of sandalwood, 6g of agarwood, 50g of raw Astragalus, 6g of Cyperus rotundus, 10g of Saposhnikovia divaricata, 10g of Pinus tabulaeformis, 10g of Prunus mume, and 10g of Sophora flavescens.

[0144] The preparation method and instructions for use are consistent with those of Example 1.

[0145] Comparative Example 1

[0146] A Chinese medicine composition for treating paroxysmal atrial fibrillation, the raw material composition is as follows:

[0147] 15g of Dalbergia odorifera, 5g of earthworm, 3g of agarwood, 30g of raw Astragalus, 3g of Cyperus rotundus, 5g of Platycladus orientalis, 15g of Pinus tabulaeformis, 10g of mother of pearl, and 5g of Salvia miltiorrhiza.

[0148] Preparation method: Mix the above raw materials together, put them in a casserole, add water to cover the surface of the medicine, soak for 20-30 minutes, then decoct with low heat, continue to decoct for 30 minutes after boiling, decoct three times in total, combine the three decoctions and filter to obtain a decoction.

[0149] Directions for use: Decoction, one dose per day, decocted in water and taken once in the morning and evening, one course of treatment is 28 days.

[0150] Effect evaluation:

[0151] 1. Animal Experiments

[0152] 1.1 Electrophysiological experiments

[0153] SD rats were randomly divided into a blank group, a model group, a Chinese medicine group, Example 2 group-Example 4 group, a comparative example 1 group and an amiodarone group. Among them, the rats in the Chinese medicine group were gavaged with the water extract of the Chinese medicine composition provided in Example 1 every day, and the rats in Example 2 group-Example 4 group and the comparative example 1 group were gavaged with the water extract of the Chinese medicine composition provided in Example 2-Example 4 and the comparative example 1 group every day, respectively, at a dose of 8g of the Chinese medicine composition (in terms of crude drug amount) / kg rat body weight / day. Rats in the blank group and the model group were gavaged with approximately equal volumes of normal saline every day. Rats in the amiodarone group were gavaged with 50mg / kg rat body weight / day of amiodarone. The administration lasted for 14 days to model the model.

[0154] For the model group, the Chinese medicine group, the Example 2 group to the Example 4 group, the Comparative Example 1 group and the amiodarone group, a paroxysmal atrial fibrillation model was established. The rat paroxysmal atrial fibrillation model was constructed by intraperitoneal injection of isoproterenol (ISO) combined with esophageal pacing electrical stimulation, and the differences in basic electrocardiogram parameters (heart rate, PR interval, QRS wave width), effective refractory period, atrial fibrillation induction rate and atrial fibrillation duration of rats in each group before and after intraperitoneal injection were observed. The atrial fibrillation induction rate was determined according to the number of atrial fibrillation attacks, and the duration of atrial fibrillation was recorded.

[0155] The results show that the water extract of the Chinese medicine composition provided by the present invention can inhibit the shortening of the effective refractory period of the rat atrium caused by ISO to a certain extent, has an anti-arrhythmic effect, and can significantly reduce the number and duration of atrial fibrillation induction in rats with paroxysmal atrial fibrillation model. The atrial fibrillation induction rate of the model group rats after electrical stimulation is 98.41%, and the duration of atrial fibrillation is up to 232.35s; the atrial fibrillation induction rate of the rats in the Chinese medicine group decreased after 14 days of intragastric administration of the water extract of the Chinese medicine composition of the present invention, and the duration of atrial fibrillation was significantly shortened (P < 0.05), indicating that the water extract of the Chinese medicine composition of the present invention can reduce the number and duration of atrial fibrillation induction in rats, and effectively inhibit the occurrence and maintenance of atrial fibrillation. The details are shown in Tables 1 and 2 below.

[0156] Table 1 Comparison of the number of atrial fibrillation induced by electrical stimulation in rats among the groups

[0157] Group Quantity (pcs) Induced (times) Not induced (times) AF inducibility rate Model Group 11 62 1 98.41％ Chinese Medicine Group 10 <![CDATA[40 △△ ]]> <![CDATA[16 △△ ]]> 71.43％ Example 2 Group 10 <![CDATA[42 △△ ]]> <![CDATA[13 △△ ]]> 76.36％ Example 3 Group 10 <![CDATA[44 △△ ]]> <![CDATA[12 △△ ]]> 78.57％ Example 4 Group 10 <![CDATA[46 △△ ]]> <![CDATA[12 △△ ]]> 79.31％ Comparative Example 1 10 <![CDATA[45 △△ ]]> <![CDATA[8 △△ ]]> 84.91％ Amiodarone group 10 <![CDATA[29 △△ ]]> <![CDATA[21 △△ ]]> 58.00％

[0158] Note: Compared with the model group, △△ P<0.01.

[0159] Table 2 Comparison of duration of induced atrial fibrillation (AF) in rats among groups (mean (minimum-maximum))

[0160] Group Quantity (pcs) AF duration (s) Model Group 11 38.99(31.39-59.5) Chinese Medicine Group 10 <![CDATA[26.21(10.09-37.55) *△ ]]> Example 2 Group 10 <![CDATA[27.04(10.39-38.95) *△ ]]> Example 3 Group 10 <![CDATA[27.27(12.41-40.03) *△ ]]> Example 4 Group 10 <![CDATA[27.49(13.49-41.47) *△ ]]> Comparative Example 1 10 <![CDATA[29.05(15.64-47.91) *△ ]]> Amiodarone group 10 <![CDATA[7.53(3.3-11.35) ** ]]>

[0161] Note: Compared with the model group,* P<0.05, ** P<0.01; compared with the amiodarone group, △ P<0.05.

[0162] 1.2 Study on the effect of the Chinese medicine composition of the present invention on the β1-AR / cAMP / PKA signaling pathway

[0163] After the atrial fibrillation experiment, the rats in each group were killed, and the atrial tissues of the rats were taken to detect the expression of related proteins and genes. The test results are shown in Tables 3, 4 and Figure 1-Figure 3 shown.

[0164] Table 3 Comparison of relative expression levels of target genes in atrial tissue of rats in each group

[0165]

[0166]

[0167] Note: Compared with the blank group, * P<0.05, ** P<0.01; compared with the model group, △ P<0.05, △△ P<0.01.

[0168] Table 4 Comparison of grayscale ratios of target protein expression in atrial tissue of rats in each group

[0169]

[0170] Note: Compared with the blank group, * P<0.05, ** P<0.01; compared with the model group, △ P<0.05, △△ P<0.01.

[0171] In summary, the related proteins and gene expressions in the atrial myocytes of rats in different groups were detected by ELISA, Western blot, PCR detection and other methods, and it was found that the Chinese medicine composition of the present invention can reduce the expression of ADRB1 and Cav1.2 proteins and genes in the atrial muscle tissue of rats with paroxysmal atrial fibrillation, reduce the expression of PKA and RyR2 genes, and reduce the level of norepinephrine (NE) in serum, thereby inhibiting sympathetic nerve activity, inhibiting RyR2 protein and gene expression, regulating calcium channels, reversing calcium overload, and promoting calcium homeostasis. This may be the potential mechanism of the Chinese medicine composition of the present invention for treating paroxysmal atrial fibrillation.

[0172] 2. Clinical efficacy trials

[0173] In order to prove the efficacy of the Chinese medicine composition of the present invention, the Chinese medicine composition of the present invention was added to Western medicine in the method of loading treatment with Chinese medicine, and its efficacy on patients with paroxysmal atrial fibrillation was studied in terms of atrial fibrillation attack frequency, duration, TCM syndrome score, ventricular rate, etc.

[0174] 2.1 Research Methods

[0175] This study adopted a prospective, randomized, double-blind single-dummy test method, and randomly divided 90 patients with atrial fibrillation into a treatment group and a control group of 45 cases in each group. The treatment group and the control group were treated with the Chinese medicine composition of the present invention on the basis of conventional Western medicine treatment, 1 dose per day, twice a day, once in the morning and once in the evening. The number and duration of atrial fibrillation, conversion rate, TCM syndrome score, atrial fibrillation symptom classification, ventricular rate, Pittsburgh sleep quality index, anxiety and depression score of the two groups of patients were observed before and after treatment. The clinical efficacy and TCM syndrome efficacy were determined after treatment. Adverse reactions and adverse events were recorded during treatment.

[0176] 2.2 Drugs used in clinical studies:

[0177] Drugs in the treatment group: Dalbergia odorifera 15g, Santalum album 10g, Aquilaria wood 3g, Raw Astragalus 30g, Cyperus rotundus bark 3g, Saposhnikovia divaricata 5g, Pinus tabulaeformis 15g, Prunus mume 5g, Sophora flavescens 5g.

[0178] Drugs in the control group: 9 grams of Dalbergia odorifera, 5 grams of Aquilaria wood, 10 grams of Salvia miltiorrhiza, 6 grams of Pheretima chinensis, 5 grams of Platycladus orientalis, 20 grams of Mother of Pearl, 15 grams of Pinus tabulaeformis, 25 grams of Raw Astragalus, and 3 grams of Cyperus rotundus.

[0179] Preparation method: Mix each group of raw materials together, put them in a casserole, add water to cover the medicine surface, soak for 20-30 minutes, then decoct with low heat, continue to decoct for 30 minutes after boiling, decoct three times in total, combine the three decoctions and filter to obtain a decoction.

[0180] 2.3. Research results

[0181] 2.3.1 Comparison of the number and duration of atrial fibrillation between the two groups before and after treatment

[0182] As shown in Table 5, there was no statistically significant difference between the two groups before treatment (P>0.05). After treatment, the number and duration of atrial fibrillation in both groups were significantly reduced compared with before treatment (P<0.01). After treatment, the number and duration of atrial fibrillation in the treatment group were less than those in the control group (P<0.01).

[0183] Table 5 The number and duration of paroxysmal atrial fibrillation in the two groups of patients with qi stagnation and blood stasis syndrome (M (P 25 ,P 75 ))

[0184]

[0185] Note: a) Compared with the group before treatment, P < 0.01.

[0186] 2.3.2 Comparison of clinical efficacy between the two groups of patients

[0187] As shown in Table 6 (unit: case (%), χ 2 =0.104, "-" indicates no content), the total effective rate of clinical efficacy in the treatment group was 82.22%, and that in the control group was 60.00%, and the treatment group was superior to the control group (P>0.05).

[0188] Table 6 Comparison of clinical efficacy between the two groups of patients with paroxysmal atrial fibrillation of qi stagnation and blood stasis type

[0189]

[0190] 2.3.3 Comparison of recovery rates between the two groups after treatment

[0191] As shown in Table 7 (unit: case (%), χ 2 =0.055), the conversion rate of the treatment group was 26.67%, and that of the control group was 6.67%, and the treatment group was superior to the control group (P>0.05).

[0192] Table 7 Comparison of cardioversion rates between the two groups of patients with paroxysmal atrial fibrillation of qi stagnation and blood stasis type

[0193]

[0194] 2.3.4 Comparison of TCM syndrome scores between the two groups before and after treatment

[0195] As shown in Table 8, there was no significant difference between the two groups before treatment (P>0.05). After treatment, the syndrome scores of the two groups were significantly reduced compared with those before treatment (P>0.05).

[0196] Table 8 Comparison of TCM syndrome scores between the two groups of patients with paroxysmal atrial fibrillation of qi stagnation and blood stasis type

[0197]

[0198] Note: a) Compared with the group before treatment, P < 0.001.

[0199] 2.3.5 Comparison of TCM syndrome efficacy between the two groups of patients

[0200] From Table 9 (unit: case (%); 2 =0.123, "-" indicates no content), the TCM syndrome efficacy in the treatment group was 88.89%, and that in the control group was 66.67%, and the treatment group was superior to the control group (P>0.05).

[0201] Table 9 Comparison of TCM syndrome efficacy between two groups of patients with Qi stagnation and blood stasis type paroxysmal atrial fibrillation

[0202]

[0203] 2.3.6 Comparison of atrial fibrillation symptom classification between the two groups before and after treatment

[0204] As shown in Table 10, there was no statistically significant difference in the grading of atrial fibrillation symptoms between the two groups before treatment (P>0.05). After treatment, the severity of atrial fibrillation symptoms in both groups improved compared with before treatment (P<0.01). After treatment, there was no significant difference in the improvement of the severity of atrial fibrillation symptoms in the treatment group and the control group (P>0.05).

[0205] Table 10 Comparison of atrial fibrillation symptom classification between the two groups of patients before and after treatment 2.3.7 Comparison of ventricular rate between the two groups of patients before and after treatment

[0206]

[0207] As shown in Table 11 (unit: times / min), there was no statistically significant difference between the two groups before treatment (P>0.05). After treatment, the ventricular rate of both groups of patients was significantly lower than that before treatment (P<0.001). After treatment, the ventricular rate of the treatment group was lower than that of the control group, but there was no statistical difference (P>0.05).

[0208] Table 11 Comparison of ventricular rate before and after treatment in two groups of patients with paroxysmal atrial fibrillation of qi stagnation and blood stasis type

[0209]

[0210] Note: a) Compared with the group before treatment, P < 0.001.

[0211] 2.3.8 Comparison of Pittsburgh Sleep Quality Index (PSQI) and Anxiety and Depression Index between the two groups before and after treatment

[0212] As shown in Table 12, there was no statistically significant difference between the two groups before treatment (P>0.05). After treatment, the PSQI (P<0.001), anxiety index (P<0.001), and depression index (P<0.01) of the treatment group were significantly lower than those before treatment. After treatment, the PSQI (P<0.01) and anxiety index (P<0.05) of the control group were lower than those before treatment. After treatment, the PSQI, anxiety and depression index of the treatment group were lower than those of the control group (P<0.05).

[0213] Table 12 Comparison of PSQI and anxiety and depression index between the two groups of patients with paroxysmal atrial fibrillation of qi stagnation and blood stasis before and after treatment

[0214]

[0215] Note: a) Compared with the group before treatment, P < 0.001; b) Compared with the group before treatment, P < 0.01; c) Compared with the group before treatment, P > 0.05.

[0216] 2.3.9 Comparison of the number and proportion of patients with diarrhea after treatment between the two groups

[0217] As shown in Table 13 (“-” indicates no content), the diarrhea rate in the treatment group was 31.11%, and that in the control group was 6.67%. The treatment group was superior to the control group (χ 2 =0.123, P>0.05).

[0218] Table 13 Comparison of the number and proportion of patients with diarrhea after treatment in the two groups

[0219]

[0220] 2.3.10 Safety evaluation of the two groups of patients

[0221] No adverse reactions or adverse events occurred in the two groups of patients during the treatment. The values ​​of blood, urine, stool, liver and kidney function, and coagulation function before and after treatment were all within the safe range.

[0222] Application Examples

[0223] Case 1

[0224] Guo, female, 65 years old, was diagnosed with chest tightness and palpitations for 2 years, which worsened for 1 month. She was diagnosed with chest tightness and palpitations without obvious causes 2 years ago. She was diagnosed with atrial fibrillation at a local hospital. The electrocardiogram showed paroxysmal atrial fibrillation. She was given bisoprolol fumarate 2.5mg once a day. After taking the medicine, her heart rate dropped to 55 beats / min. During this period, chest tightness and palpitations occurred intermittently. One month ago, the symptoms worsened without obvious causes, accompanied by insomnia and anxiety. She was diagnosed with a local hospital again and was advised to stop taking bisoprolol fumarate and take sotalol 40mg once a day instead. After taking the medicine, her heart rate was 48-50 beats / min, and the symptoms did not improve, so she sought treatment from traditional Chinese medicine. Current symptoms: palpitation, chest tightness and shortness of breath, general fatigue, dull pain in the precordial area, dry mouth and thirst, hot flashes and sweating, anxiety, irritability, frequent atrial fibrillation, 2-3 times / week, each lasting 30 minutes to 2 hours, poor appetite, poor sleep, easy to wake up and difficult to recover, sleep 4 hours per night, frequent atrial fibrillation at night, and normal bowel movements. Electrocardiogram (ECG): paroxysmal atrial fibrillation. Echocardiogram: left atrial diameter (LA) 41mm. Dynamic electrocardiogram: heart rate (HR) 74 beats / min, heart rate variability (SDNN): 75ms. Western medicine diagnosis: paroxysmal atrial fibrillation; insomnia; anxiety state. Traditional Chinese medicine diagnosis: palpitations (Qi stagnation, blood stasis, restlessness syndrome). The Chinese medicine composition of the present invention is given: 15g of Dalbergia odorifera, 10g of Santalum album, 6g of Aquilaria sinensis, 30g of Radix Astragali, 6g of Persimmon bark, 10g of Saposhnikovia divaricata, 10g of Pinus tabulaeformis, 10g of Plum, and 10g of Sophora flavescens. One dose per day, decocted in water, divided into morning and evening. After taking the medicine for 3 months, the patient's above symptoms were reduced, the condition was stable, and there was no obvious discomfort. Auxiliary examination: LA: 38mm, HR: 62 times / min, SDNN: 157ms.

[0225] Case 2

[0226] Mr. Li, male, 60 years old, was diagnosed with "intermittent palpitations for more than 3 years" in October 2020. In 2017, the patient experienced palpitations and shortness of breath after fatigue. He went to a local hospital for an electrocardiogram and was diagnosed with "paroxysmal atrial fibrillation". He was given amiodarone and then cardioverted. From 2017 to March 2020, atrial fibrillation occurred intermittently, and amiodarone was used for cardioversion each time. In April 2020, he began to take Betaloc 25mg, half a tablet in the morning and one tablet in the evening, and the symptoms of palpitations and shortness of breath were alleviated. Current symptoms: occasional palpitations, shortness of breath, fatigue, easy sweating, easy irritability, chest and flank distension and pain, dark complexion, poor appetite, difficulty falling asleep, sometimes sleepless all night, easy to wake up, dreamy, and regular bowel movements. Echocardiogram shows: left atrial diameter (LA) 32mm. Dynamic electrocardiogram: heart rate (HR) 73 beats / min, heart rate variability (SDNN): 136ms. Western medicine diagnosis: paroxysmal atrial fibrillation; insomnia. Chinese medicine diagnosis: palpitations (Qi stagnation and blood stasis, restlessness). The Chinese medicine composition of the present invention is given: 15g of Dalbergia odorifera, 10g of Santalum album, 6g of Aquilaria sinensis, 20g of Radix Astragali, 6g of Persimmon bark, 10g of Saposhnikovia divaricata, 10g of Pinus tabulaeformis, 10g of Plum, and 10g of Sophora flavescens. One dose per day, decocted in water, divided into morning and evening. After taking the medicine for more than one month, the patient's symptoms were basically relieved and the condition was stable. Auxiliary examination: echocardiogram showed: LA: 32mm, HR: 68 times / min; SDNN: 173ms.

[0227] Case 3

[0228] Meng, male, 72 years old, was diagnosed in August 2020 due to "intermittent palpitations for 5 years, aggravated for more than 1 month". Five years ago, the patient developed palpitations after getting angry, accompanied by dizziness and shortness of breath, which were relieved after rest. Later, the symptoms were mild and intermittent, and no systematic diagnosis and treatment was given. One month ago, the patient was anxious and angry about trivial matters and his palpitations worsened, accompanied by chest tightness and shortness of breath, so he went to the emergency department of the local hospital. The electrocardiogram showed atrial fibrillation, which was converted after intravenous infusion of amiodarone. Later, betaloc 25mg was given once a day. The patient felt that the effect was not good, so he stopped using it. Current symptoms: palpitations, dizziness, chest tightness and shortness of breath, chest pressure, fatigue, drowsiness, irritability, bloating after meals, mild edema of the lower limbs, poor sleep, difficulty falling asleep, depression, urination, unformed stool, 1 time / 1 day. Echocardiogram: left atrial diameter (LA) 37mm. Holter shows: heart rate (HR) 63 times / min, heart rate variability (SDNN): 60.7ms. Western medicine diagnosis: paroxysmal atrial fibrillation; insomnia; depressive state. Chinese medicine diagnosis: palpitations (Qi stagnation and blood stasis, restlessness). The Chinese medicine composition of the present invention is given: 15g of Dalbergia odorifera, 10g of Santalum album, 6g of Aquilaria sinensis, 50g of Raw Astragalus, 6g of Persimmon bark, 10g of Saposhnikovia divaricata, 10g of Pinus tabulaeformis, 10g of Plum, and 10g of Sophora flavescens. One dose per day, decocted in water, divided into morning and evening. After taking the medicine for more than 2 months, the patient's symptoms were significantly relieved and all symptoms were stable. Auxiliary examination: echocardiogram: LA: 37mm. Holter shows: heart rate (HR) 61 times / min, heart rate variability (SDNN): 75.7.

[0229] summary:

[0230] Based on clinical experience and TCM theory, the inventor innovatively proposed a treatment method for paroxysmal atrial fibrillation using the Chinese medicine composition of the present invention based on the theory of "pulse and spirit harmony". Through TCM theory exploration, the theoretical basis was established and gradually improved, and a series of clinical studies were carried out. Retrospective clinical trials and prospective cohort studies based on the real world showed that the Chinese medicine composition can significantly inhibit the onset and maintenance of paroxysmal atrial fibrillation, reduce the discomfort symptoms caused by atrial fibrillation, and improve the quality of life of patients, fully verifying the feasibility of the theory and the effectiveness of the treatment method. At the same time, in order to further clarify the treatment mechanism, basic research on electrophysiology, ion channels and related signal pathways was carried out successively, and it was preliminarily clarified that the reduction of ADRB1, Cav1.2, PKA and RyR2 gene and protein expression based on the β1-AR / cAMP / PKA signaling pathway, the regulation of calcium channels, and the promotion of calcium homeostasis are the potential mechanisms of the Chinese medicine composition of the present invention for the treatment of paroxysmal atrial fibrillation.

[0231] The above shows and describes the basic principle and main features of the present invention and the advantages of the present invention. It should be noted that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the basic principle of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating paroxysmal atrial fibrillation, characterized in that: The Chinese medicine composition consists of the following ingredients by weight: 10-30 parts of dalbergia odorifera, 5-15 parts of santalin, 3-6 parts of agarwood, 20-60 parts of astragalus, 3-10 parts of perilla bark, 5-15 parts of siler, 10-30 parts of tabulaeformis, 5-15 parts of ebony and 3-10 parts of sophora flavescens.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition consists of the following ingredients by weight: 15 parts of dalbergia odorifera, 5-10 parts of santalin, 3-6 parts of agarwood, 20-50 parts of astragalus, 3-6 parts of angelica sinensis bark, 5-15 parts of siler, 10-15 parts of tabulaeformis, 5-15 parts of ebony root and 3-10 parts of sophora flavescens.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition consists of the following ingredients by weight: 15 parts of Dalbergia odorifera, 5 parts of Santalum album, 3 parts of Aquilaria wood, 60 parts of Astragalus membranaceus, 6 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 10 parts of Prunus mume and 5 parts of Sophora flavescens.

4. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition consists of the following ingredients by weight: 15 parts of Dalbergia odorifera, 10 parts of Santalum album, 3 parts of Aquilaria wood, 30 parts of Astragalus membranaceus, 3 parts of Perennial Herb, 5 parts of Saposhnikovia divaricata, 15 parts of Pinus tabulaeformis, 5 parts of Prunus mume and 5 parts of Sophora flavescens.

5. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The astragalus is raw astragalus.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: The following steps are involved: Mix the formulated amounts of Dalbergia odorifera, Sandalwood, Aquilaria wood, Astragalus, Cyperus rotundus, Saposhnikovia divaricata, Pinus tabulaeformis, Prunus mume and Sophora flavescens.

7. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine composition prepared by the preparation method according to claim 6 in the preparation of a medicament for treating paroxysmal atrial fibrillation.

8. A drug, characterized in that A Chinese medicine composition comprising any one of claims 1 to 4.

9. The drug according to claim 8, characterized in that Pharmaceutically acceptable excipients are also included.

10. The drug according to claim 8, characterized in that The dosage form of the medicine includes paste prescription, decoction, pill, powder, capsule or tablet.

Images