Traditional Chinese medicine composition for preventing and / or treating atrial arrhythmia and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, and particularly relates to a traditional Chinese medicine composition and its application for the prevention and / or treatment of atrial arrhythmias. The composition comprises the following medicinal materials: raw Astragalus membranaceus, Ophiopogon japonicus, Platycodon grandiflorus, Cimicifuga foetida, Bupleurum chinense, Platycladus orientalis seed, Sophora flavescens, Imperata cylindrica root, raw ginseng, raw dragon bone, and raw oyster shell. The composition effectively improves palpitations, chest tightness, and shortness of breath caused by atrial arrhythmias. Its raw materials are mild, the proportions are reasonable, and the materials are inexpensive and readily available, making it suitable for large-scale production.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition and its application for the prevention and / or treatment of atrial arrhythmias. Background Technology

[0002] Cardiac arrhythmia is a common cardiovascular disease in clinical practice, and modern medical treatment mainly relies on antiarrhythmic drugs. Commonly used antiarrhythmic drugs are classified into four categories: Class I are sodium channel blockers, which slow conduction and prolong the action potential duration, and are further divided into subtypes Ia, Ib, and Ic; Class II are beta-blockers, with metoprolol as a representative drug; Class III are potassium channel blockers, which inhibit potassium ion current and prolong repolarization time, with amiodarone as a representative drug; and Class IV are calcium channel blockers, commonly used drugs such as verapamil and diltiazem. Although these drugs are widely used, they have significant drawbacks: propafenone can inhibit left ventricular function and induce serious arrhythmias; metoprolol inhibits myocardial contractility and has poor efficacy as a single agent; amiodarone carries the risk of ventricular fibrillation and adverse reactions such as pulmonary toxicity and liver and kidney damage. Long-term use can also easily lead to drug resistance, drug interactions, and various side effects.

[0003] Non-pharmacological treatments include cryoballooning, catheter radiofrequency ablation, and cardiac pacing, among which catheter radiofrequency ablation is currently the most effective non-pharmacological method. Dual-chamber pacemakers combined with CLS can reduce recurrence in certain syncope patients. However, these technologies suffer from limited clinical experience, high costs, and limited lifespan, making them difficult to widely adopt.

[0004] Traditional Chinese medicine classifies arrhythmia under the categories of "palpitation" and "anxiety," with the core pathogenesis being insufficient heart qi and deficiency of yin and blood. The "Huangdi Neijing" and "Jingyue Quanshu" laid the theoretical foundation for the treatment of this disease by tonifying qi and nourishing yin. The value of traditional Chinese medicine in the treatment of cardiovascular diseases is receiving increasing attention.

[0005] In view of this, the present invention is proposed. Summary of the Invention

[0006] In order to overcome the shortcomings of the prior art, the present invention proposes a traditional Chinese medicine composition and its application for the prevention and / or treatment of atrial arrhythmias.

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition for the prevention and / or treatment of atrial arrhythmias, the traditional Chinese medicine composition being composed of the following traditional Chinese medicinal materials: raw Astragalus membranaceus, Ophiopogon japonicus, Platycodon grandiflorus, Cimicifuga foetida, Bupleurum chinense, Platycladus orientalis seed, Sophora flavescens, Imperata cylindrica root, raw ginseng, raw dragon bone, and raw oyster shell.

[0008] Furthermore, the traditional Chinese medicine composition comprises the following traditional Chinese medicinal materials: Astragalus membranaceus 5-30 parts, Ophiopogon japonicus 5-30 parts, Platycodon grandiflorus 3-10 parts, Cimicifuga foetida 3-10 parts, Bupleurum chinense 3-10 parts, Platycladus orientalis seed 5-10 parts, Sophora flavescens 3-10 parts, Imperata cylindrica root 5-30 parts, Panax ginseng 5-10 parts, raw dragon bone 10-30 parts, and raw oyster shell 10-30 parts.

[0009] It should be noted that the Chinese medicinal materials in the Chinese medicine composition of this application—raw Astragalus membranaceus, Ophiopogon japonicus, Platycodon grandiflorus, Cimicifuga foetida, Bupleurum chinense, Platycladus orientalis seed, Sophora flavescens, Imperata cylindrica root, raw ginseng, raw dragon bone, and raw oyster shell—are either directly purchased or prepared by processing the raw materials according to the legally prescribed processing methods in the Chinese Pharmacopoeia.

[0010] Raw astragalus has a sweet taste and slightly warm nature, and enters the lung and spleen meridians. It is good at tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, and promoting circulation and relieving pain. It is an important medicine for tonifying qi and raising yang. It can tonify heart qi, consolidate the exterior, and improve symptoms such as insufficient heart qi, shortness of breath, fatigue, and palpitations. Its pharmacological effects of antiarrhythmic and cardiac function improvement are consistent with these effects.

[0011] Platycodon grandiflorus has a bitter and pungent taste, is neutral in nature, and enters the lung meridian. It can promote lung function, soothe the throat, eliminate phlegm, and drain pus. It also carries other medicines upward and opens up lung qi, which can help other medicines reach the heart, regulate qi, and help lift the clear yang in the chest, relieving palpitations and chest tightness caused by qi stagnation.

[0012] Imperata cylindrica root is sweet and cold in nature, and enters the lung, stomach, and bladder meridians. It has the effects of cooling blood and stopping bleeding, clearing heat and promoting diuresis, and generating fluids and quenching thirst. It is sweet and cold without harming the stomach, and can clear stagnant heat and protect yin fluids. It can help improve palpitations accompanied by internal heat and irritability, and works synergistically with Sophora flavescens to clear heat without being too drying.

[0013] Sun-dried ginseng has a sweet and slightly bitter taste, and is slightly warm in nature. It enters the spleen, lung, and heart meridians. It is good at greatly replenishing vital energy, restoring the pulse and consolidating the body, and tonifying qi and controlling blood. It also strongly tonifies heart qi, strengthens the heart and restores the pulse. It targets the core pathogenesis of heart qi deficiency and irregular pulse, and enhances the overall qi-tonifying, palpitation-relieving, and heart rhythm-stabilizing effects of the formula.

[0014] Cimicifuga rhizome enters the lung, spleen, stomach, and large intestine meridians, and is effective in raising yang qi. It mainly contains triterpenoid glycosides, phenylpropanoids, nitrogen-containing compounds, chromones, flavonoids, and 4α-methyl steroids. With triterpenoid glycosides as the core active substance, it has pharmacological activities such as antiviral, antitumor, antioxidant, and anti-angiogenic effects. Clinically, it can be used for menopausal syndrome, osteoporosis, and other conditions.

[0015] Bupleurum has a pungent and bitter taste, is slightly cold in nature, and enters the liver, gallbladder, and lung meridians. It can soothe the liver and relieve depression, and raise yang qi. Its extract can inhibit myocardial cell apoptosis, and its low polarity sites can improve depressive-like behavior and increase the diversity of intestinal flora.

[0016] Ophiopogon japonicus enters the heart, lung, and stomach meridians, and has the effects of nourishing yin and promoting body fluids, moistening the lungs and clearing the heart. It can prolong clotting time and exert antithrombotic and thrombolytic effects. Its Ophiopogon japonicus polysaccharide can protect ischemic myocardium, reduce myocardial damage, enhance ATPase activity, and reduce oxidative stress levels. Ophiopogon japonicus root extract can protect the heart in heart failure through anti-inflammatory and antioxidant effects.

[0017] Arborvitae seed kernels are neutral in nature and sweet in taste. They enter the heart, liver, kidney, and large intestine meridians. They can calm the mind and soothe the nerves, astringe sweat and promote body fluid production, and moisten the intestines and relieve constipation. They mainly contain oils, amino acids, terpenes and other components, which have the effects of calming the nerves, improving sleep, and protecting the nerves.

[0018] Dragon bone and oyster shell are a commonly used drug pair in clinical practice. They complement each other, and the decoction has a higher content of trace elements, resulting in a synergistic effect. Dragon bone, being heavy and sinking, can calm the mind and soothe the nerves, regulate the autonomic nervous system, reduce sympathetic nerve excitability, and enhance vagal nerve activity, thus possessing sedative, hypnotic, and anticonvulsant effects. Oyster shell, with its salty taste, can soften and disperse nodules, and has effects such as enhancing immunity, anti-tumor activity, lowering blood sugar, and protecting vascular endothelium. It is a frequently used drug in antiarrhythmic formulas.

[0019] Sophora flavescens has a bitter taste and cold properties. It enters the heart, liver, stomach, large intestine, and bladder meridians. It can clear heat and dry dampness, and soothe the five internal organs. The alkaloids it contains, such as oxymatrine, have cardiovascular protective effects. Matrine can improve myocardial damage, enhance myocardial contractility, and prolong the ectopic automaticity of myocardial cells, thereby exerting an antiarrhythmic effect.

[0020] Since the heart's beating primarily depends on the sufficiency of heart qi and blood, if heart qi is deficient, the heart's pumping power is weak, leading to impaired blood circulation and palpitations. Deficiency of qi and blood also prevents the heart vessels from being nourished and the mind from being properly nourished, resulting in palpitations, anxiety, insomnia, and forgetfulness. Blood belongs to yin; deficiency of heart blood leads to insufficient heart yin, which disrupts the cooling and calming functions, causing palpitations, irritability, insomnia, and excessive dreaming. The *Suwen* (Plain Questions) states, "Below the breasts, movement should be felt through clothing, indicating the leakage of ancestral qi," suggesting a close relationship between palpitations and qi deficiency. For palpitations due to both qi and yin deficiency, treatment should focus on tonifying qi and nourishing yin to harmonize yin and yang, ensure smooth qi and blood circulation, nourish heart yin, and replenish heart qi, thus stopping palpitations. Combining modern TCM's understanding of the pathology of arrhythmia, the principle of prescription is to raise qi, nourish yin, calm the mind, and restore rhythm. The traditional Chinese medicine composition of this application mainly regulates the downward sinking of Qi, while Shengmai San mainly nourishes Qi and Yin, supplemented by heat-clearing and calming drugs, forming a comprehensive conditioning system.

[0021] The formulation of this herbal composition is as follows: Astragalus membranaceus and raw ginseng are the principal herbs, which tonify qi and raise yang, strengthen the defensive qi and consolidate the exterior, and improve symptoms of insufficient heart qi, shortness of breath, and fatigue; Ophiopogon japonicus and Platycladus orientalis seeds are the assistant herbs, which nourish yin and moisten dryness, nourish the heart and calm the mind, and relieve symptoms of yin deficiency with internal heat, palpitations, and insomnia; Cimicifuga foetida, Bupleurum chinense, Platycodon grandiflorus, Sophora flavescens, and Imperata cylindrica are the adjuvant herbs, which raise qi, soothe the liver and relieve depression, promote lung function and benefit the throat, and assist Astragalus membranaceus in raising clear yang and improving qi sinking; Sophora flavescens and Imperata cylindrica clear heat and dry dampness, cool blood and detoxify; raw dragon bone and raw oyster shell are the guiding herbs, which calm the mind, subdue yang and astringe sweat, harmonize yin and yang, and stabilize the mind. Thus, the combination of these herbs achieves the effect of treating both the root cause and the symptoms, and addressing both internal and external symptoms.

[0022] Based on the principles of monarch, minister, assistant and guide in the formulation and modern pharmacological research, this formula is designed with dosage in mind. It focuses on the effects of invigorating qi and nourishing yin, regulating qi, clearing heat and calming the mind, and resisting arrhythmia. The dosage distribution is clear and safe.

[0023] Astragalus and ginseng are the principal herbs. Astragalus has the widest dosage range and is used in the largest quantity, emphasizing its core functions of tonifying qi, raising yang, and strengthening the body's defenses. The dosage can be flexibly adjusted according to the degree of qi deficiency. Ginseng has a strong qi-tonifying effect, so it is used in small doses to tonify qi without being too drying or irritating, thus avoiding exacerbating the heart fire. Ophiopogon japonicus and Platycladus orientalis are the assistant herbs. The dosage of Ophiopogon japonicus is similar to that of the principal herb Astragalus, strengthening its effects of nourishing yin and generating fluids, nourishing the heart and calming the mind, and protecting ischemic myocardium. Platycladus orientalis calms the mind and soothes the nerves, and is used in moderate doses to calm the mind and relieve palpitations without being greasy or slippery. Cimicifuga, Bupleurum, Platycodon grandiflorus, Sophora flavescens, and Imperata cylindrica are the adjuvant herbs. Cimicifuga, Bupleurum, and Platycodon grandiflorus are used in light doses to help the principal herbs raise clear yang, soothe the liver and relieve depression, and regulate qi, avoiding excessive dispersion that depletes qi and damages yin. Sophora flavescens is used in small doses to clear heat in the heart, exerting its antiarrhythmic and myocardial protective effects, while preventing its bitter and cold properties from damaging the stomach. Imperata cylindrica has a wide dosage range, clearing heat and cooling blood, and nourishing yin without harming the body's vital energy. Raw dragon bone and raw oyster shell are used as adjuvants. The two are used in equal amounts and complement each other. The dosage is appropriate. They have a strong calming and sedative effect, suppress yang and stop sweating, regulate the autonomic nerve function of the heart, and stabilize the heart rhythm. They are heavy and sinking without affecting the stomach.

[0024] The formula is composed of a principal drug that leads the treatment, an assistant drug that assists, a adjuvant drug that regulates the condition, and a guiding drug that harmonizes the condition. It is orderly, dynamic and static, and suitable for both cold and hot conditions. It conforms to the theory of traditional Chinese medicine compatibility and the characteristics of modern pharmacology. It can meet the needs of different conditions and is safe and effective.

[0025] Furthermore, the traditional Chinese medicine composition is an oral preparation.

[0026] Furthermore, the dosage form of the oral preparation is granules or decoction.

[0027] Furthermore, the traditional Chinese medicine composition comprises the following herbs: Astragalus membranaceus 5-30 parts, Ophiopogon japonicus 5-30 parts, Platycodon grandiflorus 3-10 parts, Cimicifuga foetida 3-10 parts, Bupleurum chinense 3-10 parts, Platycladus orientalis seed 5-10 parts, Sophora flavescens 3-10 parts, Imperata cylindrica root 5-30 parts, Panax ginseng 5-10 parts, raw dragon bone 10-30 parts, and raw oyster shell 10-30 parts. Preferably, the proportions of the above herbs are suitable for granules.

[0028] Furthermore, the herbal composition comprises the following herbs: Astragalus membranaceus 5-10 parts, Ophiopogon japonicus 5-10 parts, Platycodon grandiflorus 3-5 parts, Cimicifuga foetida 3-5 parts, Bupleurum chinense 3-5 parts, Platycladus orientalis seed 5-8 parts, Sophora flavescens 3-5 parts, Imperata cylindrica root 5-10 parts, Panax ginseng 5-10 parts, raw dragon bone 10-15 parts, and raw oyster shell 10-15 parts. Preferably, the proportions of the above herbs are suitable for decoctions.

[0029] Furthermore, when the traditional Chinese medicine composition is a decoction, the traditional Chinese medicine composition is prepared by the following method: Weigh out the raw ginseng, raw dragon bone and raw oyster according to the weight, add water and boil for the first time, then let stand for the second time, and filter to obtain the first supernatant. Weigh out the following ingredients by weight: raw astragalus, ophiopogon japonicus, platycodon grandiflorus, cimicifuga foetida, bupleurum chinense, arborvitae seed, sophora flavescens, and imperata cylindrica root. Soak them in water for three hours, decoct for four hours, let stand for five hours, and then filter to obtain the second supernatant. Mix the first supernatant and the second supernatant thoroughly to obtain the final product.

[0030] Furthermore, the first duration is 30-50 minutes; and / or, The second duration is 1-3 hours; and / or, The third duration is 1-3 hours; and / or, The fourth duration is 20-30 minutes; and / or, The fifth duration is 1-3 hours.

[0031] Furthermore, when the traditional Chinese medicine composition is in the form of granules, the traditional Chinese medicine composition is prepared by the following method: Weigh out each Chinese medicinal herb according to its weight percentage and mix them together; Add water and boil, combine the decoctions from each boiling, filter, and concentrate to obtain a concentrated liquid; The concentrate is further concentrated to an extract; preferably, the extract yield is 11% to 19%. After adding excipients to the extract, it is dried and pulverized to form dry extract powder; Add the excipients to the dry soaking powder again, mix well, and granulate to obtain the final product.

[0032] The excipients mentioned above are conventional excipients in the field of traditional Chinese medicine manufacturing, such as dextrin and / or sucrose.

[0033] This application obtains the active ingredients of traditional Chinese medicine formulas by decocting them. Oral administration of these extracts can prevent and / or treat atrial arrhythmias. Those skilled in the art will understand from common sense that the simplest embodiment of this invention for preventing and / or treating atrial arrhythmias involves directly taking the decoction (if the liquid volume is too large, it can be concentrated), for example, twice a day, 200ml each time, for a course of treatment of 2 weeks. To alleviate the difficulty of medication for patients, those skilled in the art can further combine the extract of traditional Chinese medicine with conventional excipients to prepare oral granules. For example, granules formed from the concentrated extract of this invention can be taken twice a day, 200ml each time, dissolved in water, for a course of treatment of 2 weeks.

[0034] The second aspect of this invention proposes the application of the traditional Chinese medicine composition of the first aspect of this invention in the preparation of a medicine for the prevention and / or treatment of atrial arrhythmia. Clinical verification has shown that the composition of this invention is particularly effective in treating symptoms of atrial arrhythmia such as palpitations, chest tightness, shortness of breath, fatigue, excessive sweating, dry mouth, irritability, or poor sleep.

[0035] Compared with the prior art, the beneficial effects of the present invention are as follows: The traditional Chinese medicine composition of the present invention can effectively improve palpitations, chest tightness, and shortness of breath caused by atrial arrhythmia. Its raw materials are mild, the proportions are reasonable, and the raw materials are inexpensive and readily available, making it suitable for large-scale production. Detailed Implementation

[0036] The present invention will be further described below through specific embodiments, but this is not a limitation of the present invention. Those skilled in the art can make various modifications or improvements based on the basic idea of ​​the present invention, but as long as they do not depart from the basic idea of ​​the present invention, they are all within the scope of the present invention.

[0037] Example Example 1 Weigh out 30 parts by weight of Astragalus membranaceus, 30 parts of Ophiopogon japonicus, 10 parts of Platycodon grandiflorus, 10 parts of Cimicifuga foetida, 10 parts of Bupleurum chinense, 10 parts of Platycladus orientalis seed, 10 parts of Sophora flavescens, 30 parts of Imperata cylindrica root, 10 parts of raw ginseng, 30 parts of raw dragon bone, and 30 parts of raw oyster shell. Add 3000ml of water to the raw ginseng, raw dragon bone, and raw oyster shell, decoct for 60 minutes and concentrate to 200ml, let stand for 2 hours, and filter to obtain the first supernatant. Soak Astragalus membranaceus, Ophiopogon japonicus, Platycodon grandiflorus, Cimicifuga foetida, Bupleurum chinense, Platycladus orientalis seed, Sophora flavescens, and Imperata cylindrica root in 500ml of water for 2 hours, then decoct for 40 minutes and concentrate to 50ml. Let stand for 2 hours and filter to obtain the second supernatant. Mix the first and second supernatants evenly to obtain a traditional Chinese medicine composition in decoction form.

[0038] Example 2 Weigh out 10 parts by weight of Astragalus membranaceus, 10 parts of Ophiopogon japonicus, 5 parts of Platycodon grandiflorus, 5 parts of Cimicifuga foetida, 5 parts of Bupleurum chinense, 5 parts of Platycladus orientalis seed, 5 parts of Sophora flavescens, 10 parts of Imperata cylindrica root, 5 parts of raw Panax ginseng, 10 parts of raw fossilized bone, and 10 parts of raw oyster shell. Add water and decoct. Combine the decoctions from each decoction, filter, and concentrate to obtain a concentrated liquid. Further concentrate the liquid to obtain an extract. Add excipients to the extract, dry, and pulverize to form a dry extract powder. Add excipients again to the dry extract powder, mix well, and granulate to obtain a traditional Chinese medicine composition in granule form.

[0039] Example 3 Weigh out 20 parts of Astragalus membranaceus, 20 parts of Ophiopogon japonicus, 8 parts of Platycodon grandiflorus, 8 parts of Cimicifuga foetida, 8 parts of Bupleurum chinense, 9 parts of Platycladus orientalis seed, 8 parts of Sophora flavescens, 20 parts of Imperata cylindrica root, 8 parts of raw ginseng, 28 parts of raw dragon bone, and 28 parts of raw oyster shell according to the following proportions: Add 3000ml of water to the raw ginseng, raw dragon bone, and raw oyster shell, decoct for 60 minutes and concentrate to 200ml, let stand for 2 hours, and filter to obtain the first supernatant; Soak Astragalus membranaceus, Ophiopogon japonicus, Platycodon grandiflorus, Cimicifuga foetida, Bupleurum chinense, Platycladus orientalis seed, Sophora flavescens, and Imperata cylindrica root in 500ml of water for 2 hours, then decoct for 40 minutes and concentrate to 50ml, then let stand for 2 hours and filter to obtain the second supernatant; Mix the first and second supernatants evenly to obtain a traditional Chinese medicine composition in the form of a decoction.

[0040] Example 4 Weigh out the following ingredients by weight: 25 parts Astragalus membranaceus, 15 parts Ophiopogon japonicus, 7 parts Platycodon grandiflorus, 9 parts Cimicifuga foetida, 7 parts Bupleurum chinense, 8 parts Platycladus orientalis seed, 9 parts Sophora flavescens, 25 parts Imperata cylindrica root, 7 parts raw ginseng, 15 parts raw dragon bone, and 25 parts raw oyster shell. Add 3000ml of water to the raw ginseng, dragon bone, and oyster shell, decoct for 60 minutes, concentrate to 200ml, let stand for 2 hours, and filter to obtain the first supernatant. Soak the Astragalus membranaceus, Ophiopogon japonicus, Platycodon grandiflorus, Cimicifuga foetida, Bupleurum chinense, Platycladus orientalis seed, Sophora flavescens, and Imperata cylindrica root in 500ml of water for 2 hours, then decoct for 40 minutes, concentrate to 50ml, let stand for 2 hours, and filter to obtain the second supernatant. Mix the first and second supernatants thoroughly to obtain a decoction-like traditional Chinese medicine composition.

[0041] Example 5 Weigh out 5 parts by weight of Astragalus membranaceus, 5 parts of Ophiopogon japonicus, 3 parts of Platycodon grandiflorus, 3 parts of Cimicifuga foetida, 3 parts of Bupleurum chinense, 8 parts of Platycladus orientalis seed, 3 parts of Sophora flavescens, 5 parts of Imperata cylindrica root, 10 parts of raw Panax ginseng, 15 parts of raw fossilized bone, and 15 parts of raw oyster shell. Add water and decoct. Combine the decoctions from each decoction, filter, and concentrate to obtain a concentrated liquid. Further concentrate the liquid to obtain an extract. Add excipients to the extract, dry, and pulverize to form a dry extract powder. Add excipients again to the dry extract powder, mix well, and granulate to obtain a traditional Chinese medicine composition in granule form.

[0042] Example 6 Weigh out 8 parts by weight of Astragalus membranaceus, 8 parts of Ophiopogon japonicus, 4 parts of Platycodon grandiflorus, 4 parts of Cimicifuga foetida, 4 parts of Bupleurum chinense, 7 parts of Platycladus orientalis seed, 4 parts of Sophora flavescens, 8 parts of Imperata cylindrica root, 8 parts of raw Panax ginseng, 12 parts of raw fossilized bone, and 12 parts of raw oyster shell. Add water and decoct. Combine the decoctions from each decoction, filter, and concentrate to obtain a concentrated liquid. Further concentrate the liquid to obtain an extract. Add excipients to the extract, dry, and pulverize to form a dry extract powder. Add excipients again to the dry extract powder, mix well, and granulate to obtain a traditional Chinese medicine composition in granule form.

[0043] Test case This experimental example is a clinical study of the decoction prepared in Example 1 for the treatment of atrial arrhythmia.

[0044] 1. Case Selection: Patients diagnosed with cardiac neurological dysfunction accompanied by atrial arrhythmia who visited the outpatient or inpatient department of the Cardiovascular Department of Fangshan Hospital, Beijing University of Chinese Medicine, were selected. A total of 80 eligible subjects were ultimately included in this study and randomly divided into an observation group and a control group, with 40 patients in each group. Among them: Of the 40 cases in the observation group, there were 16 males and 24 females; the average age was (62.35±8.17) years; the duration of illness was (24.15±10.23) months; and the average body mass index (BMI) was (23.87±2.41) kg / m2. The control group consisted of 40 patients, including 18 males and 22 females; the average age was (61.47±8.42) years; and the duration of illness was (24.54±9.38) months. The two groups of subjects were compared at baseline upon enrollment, and there were no statistically significant differences in their general characteristics such as gender, age, and disease duration (P>0.05), making them comparable.

[0045] 2. Treatment plan: Participants were randomly assigned to either an intervention group or a control group. All enrolled subjects received treatment and observation for two weeks. During the trial, both groups received basic lifestyle guidance as prescribed by the study protocol, including recommendations to maintain emotional stability, avoid fatigue, and limit caffeine and alcohol intake.

[0046] 2.1 The control group received routine Western medicine treatment.

[0047] The regimen is as follows: oral metoprolol succinate extended-release tablets (manufacturer: AstraZeneca Pharmaceutical Co., Ltd., National Drug Approval Number J20150044, specification: 47.5 mg / tablet), once daily. The initial dose is 23.75 mg / day. Based on the patient's heart rate (target resting heart rate controlled at 55-65 beats / min) and blood pressure (systolic blood pressure not lower than 90 mmHg) response during treatment, the dose will be gradually titrated to the target maintenance dose within 1 week under the guidance of a physician, with a maximum dose not exceeding 95 mg / day.

[0048] 2.2 The observation group received the decoction from Example 1 in addition to the routine Western medicine treatment given to the control group.

[0049] The herbal decoction pieces for Example 1 were provided and prepared by the Traditional Chinese Medicine Pharmacy of our hospital. One dose was taken daily, decocted twice with water, and the filtrates were combined, concentrated to 400ml, and divided into two packets (200ml each). Patients were instructed to take one packet warm, half an hour after breakfast and dinner. The dosage and titration regimen for metoprolol succinate sustained-release tablets were the same as the control group.

[0050] Both treatment and observation periods were 2 weeks. The observation period started on the first day of medication and ended on the day following the end of treatment. During treatment, the use of other antiarrhythmic drugs and traditional Chinese medicine decoctions or prepared medicines that have a clear effect on invigorating qi and nourishing yin, calming the mind and soothing the nerves, except as specified in the protocol, was prohibited. If a patient needed to use other medications, the name, dosage, and reason for use must be recorded in detail.

[0051] 3. Observation indicators: 3.1 Therapeutic Effects of Traditional Chinese Medicine Syndromes Before and after treatment, TCM syndrome scores were assessed according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" to calculate the total effective rate. The criteria for judging efficacy are as follows: Clinically cured: The reduction rate of TCM syndrome score is ≥90%; Significantly effective: The reduction rate of TCM syndrome score is ≥70% and <90%; Effective: The reduction rate of TCM syndrome score is ≥30% and <70%; Ineffective: The reduction rate of TCM syndrome score is <30%.

[0052] 3.2 Individual TCM symptom scores The severity of eight individual symptoms, including palpitations, chest tightness, shortness of breath, and fatigue, was quantitatively scored. The primary symptoms were scored as 0, 2, 4, and 6 points respectively, and the secondary symptoms were scored as 0, 1, 2, and 3 points respectively. Changes before and after treatment were compared.

[0053] 3.3 Therapeutic effects on atrial arrhythmias Compare 24-hour Holter monitoring results before and after treatment. Efficacy assessment: Significant effect: reduction rate of total premature atrial contractions ≥90%; Effective: reduction rate ≥50% and <90%; Ineffective: reduction rate <50%.

[0054] 3.4 Dynamic electrocardiogram parameters Analyze 24-hour Holter ECG data before and after treatment, including mean heart rate (Mean HR), standard deviation of all normal sinus intervals (SDNN), root mean square of the difference between adjacent normal intervals (RMSSD), and PNN50%.

[0055] 3.5 Heart Structure and Function Echocardiography was performed before and after treatment to record left ventricular ejection fraction (LVEF), pulse output (SV), and E / A ratio.

[0056] 3.6 Serum biological markers Fasting venous blood was collected in the morning before and after treatment to measure B-type natriuretic peptide (BNP) levels, in order to indirectly reflect cardiac load and functional status.

[0057] 3.7 Assessment of quality of life and emotional state The Chinese version of the Short Form Health Survey (SF-36) and the modified version of the Self-Rating Anxiety Scale (SAS) were used to evaluate the two groups before and after treatment, and to compare changes in quality of life and emotional state.

[0058] 3.8 Safety Indicators Record in detail any adverse events that occur during treatment (such as bradycardia, hypotension, gastrointestinal discomfort, allergic reactions, etc.), including the time of occurrence, severity, association with the investigational drug, treatment measures, and outcome.

[0059] 4. Data Processing Statistical methods were employed, and SPSS 23.0 software was used for data processing. Count data were expressed as percentages (%), and comparisons between groups were performed using... x2 For testing and measurement data, the following methods are used: This indicates that independent samples were used for comparisons between groups. t For the test, paired comparisons were used within groups. t Tests were performed. A p-value < 0.05 was considered statistically significant.

[0060] 5. Test Results 5.1. Comparison of TCM syndrome differentiation and treatment efficacy After two weeks of treatment, the total effective rate in the observation group (90.00%) was significantly higher than that in the control group (67.50%). P <0.05), see Table 1 Table 1. Comparison of TCM syndrome efficacy between the two groups of patients (n, %)

[0061] 5.2. Changes in the scores of individual TCM symptoms Two weeks after treatment, the scores of all TCM symptoms in both groups of patients decreased significantly compared with before treatment. P <0.05), in intergroup comparison, the observation group showed significantly better improvement in the scores of the five individual symptoms (palpitation, shortness of breath, fatigue, poor sleep, and dry mouth) than the control group. P <0.05), while there was no statistically significant difference between the two groups in the improvement of scores for chest tightness, excessive sweating, and hot flashes.P >0.05), see Table 2.

[0062] Table 2 Comparison of individual TCM symptom scores before and after treatment in the two groups of patients ( , point)

[0063] 5.3 Comparison of clinical efficacy for atrial arrhythmias After two weeks of treatment, the total effective rate in the observation group (82.5%) was significantly higher than that in the control group (62.5%). P <0.05), see Table 3.

[0064] Table 3. Comparison of clinical efficacy for atrial arrhythmias between the two groups of patients [n(%)]

[0065] 5.4. Comparison of Holter ECG parameters Two weeks after treatment, the heart rate variability (HRV) in both groups of patients improved compared to before treatment. P <0.05). In intergroup comparisons, the observation group was significantly better than the control group in improving SDNN, RMSSD, and PNN50 values. P <0.05), while there was no statistically significant difference in the degree of improvement in reducing mean heart rate between the two groups. P >0.05), see Table 4.

[0066] Table 4 Comparison of Holter ECG parameters before and after treatment in the two groups of patients ( )

[0067] 5.5. Comparison of cardiac structure and function After 2 weeks of treatment, the LVEF, SV, and E / A ratio in the observation group all improved significantly. P <0.05), the control group showed significant improvement in LVEF and SV ( P <0.05), but the change in the E / A ratio was not statistically significant ( P >0.05). In intergroup comparisons, the observation group was significantly better than the control group in improving LVEF, SV, and E / A ratio. P <0.05), see Table 5.

[0068] Table 5 Comparison of echocardiographic parameters before and after treatment in the two groups of patients ( )

[0069] 5.6 Changes in serum B-type natriuretic peptide (BNP) levels Two weeks after treatment, serum BNP levels in both groups decreased significantly compared to before treatment. P <0.05, in intergroup comparison, the observation group was significantly better than the control group in reducing BNP levels ( P <0.05), see Table 6.

[0070] Table 6 Comparison of serum BNP levels before and after treatment in the two groups ( (pg / mL)

[0071] 5.7 Assessment of quality of life and emotional state Two weeks after treatment, the total score of the SF-36 scale in both groups was significantly improved compared with that before treatment. P <0.05), and the SAS standard score decreased significantly compared with that before treatment ( P <0.05). In intergroup comparisons, the observation group was significantly better than the control group in increasing the total score of the SF-36 scale and decreasing the standard SAS score. P <0.05), see Table 7.

[0072] Table 7 Comparison of SF-36 total score and SAS standard score before and after treatment in the two groups ( , point)

[0073] In summary, after two weeks of treatment, the palpitation symptoms of patients with atrial arrhythmia were effectively improved. At the same time, the patients' TCM symptom scores decreased significantly, their lung function indicators improved significantly, and their 6-minute walking distance increased significantly. Furthermore, no patients in either the experimental or control groups experienced significant discomfort during the treatment period. Therefore, the TCM composition of this invention has definite clinical efficacy and can significantly improve the quality of life of patients.

[0074] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for the prevention and / or treatment of atrial arrhythmias, characterized in that, The traditional Chinese medicine composition consists of the following herbs: raw Astragalus membranaceus, Ophiopogon japonicus, Platycodon grandiflorus, Cimicifuga foetida, Bupleurum chinense, Platycladus orientalis seed, Sophora flavescens, Imperata cylindrica root, raw ginseng, raw dragon bone, and raw oyster shell.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicinal materials. Composition: Astragalus membranaceus 5-30 parts, Ophiopogon japonicus 5-30 parts, Platycodon grandiflorus 3-10 parts, Cimicifuga foetida 3-10 parts, Bupleurum chinense 3-10 parts, Platycladus orientalis seed 5-10 parts, Sophora flavescens 3-10 parts, Imperata cylindrica root 5-30 parts, Panax ginseng 5-10 parts, raw dragon bone 10-30 parts, raw oyster shell 10-30 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicinal materials. Composition: Astragalus membranaceus 5-10 parts, Ophiopogon japonicus 5-10 parts, Platycodon grandiflorus 3-5 parts, Cimicifuga foetida 3-5 parts, Bupleurum chinense 3-5 parts, Platycladus orientalis seed 5-8 parts, Sophora flavescens 3-5 parts, Imperata cylindrica root 5-10 parts, Panax ginseng 5-10 parts, raw dragon bone 10-15 parts, raw oyster shell 10-15 parts.

4. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition consists of the following herbs: Astragalus membranaceus 10-30 parts, Ophiopogon japonicus 10-30 parts, Platycodon grandiflorus 5-10 parts, Cimicifuga foetida 5-10 parts, Bupleurum chinense 5-10 parts, Platycladus orientalis seed 8-10 parts, Sophora flavescens 5-10 parts, Imperata cylindrica root 10-30 parts, Panax ginseng 5-10 parts, raw dragon bone 15-30 parts, and raw oyster shell 15-30 parts.

5. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition is an oral preparation.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, The oral preparation is in the form of granules or decoction.

7. The traditional Chinese medicine composition according to claim 6, characterized in that, When the traditional Chinese medicine composition is a decoction, the traditional Chinese medicine composition is prepared by the following method: Weigh out the raw ginseng, raw dragon bone and raw oyster according to the weight, add water and boil for the first time, then let stand for the second time, and filter to obtain the first supernatant. Weigh out the following ingredients by weight: raw astragalus, ophiopogon japonicus, platycodon grandiflorus, cimicifuga foetida, bupleurum chinense, arborvitae seed, sophora flavescens, and imperata cylindrica root. Soak them in water for three hours, decoct for four hours, let stand for five hours, and then filter to obtain the second supernatant. Mix the first supernatant and the second supernatant thoroughly to obtain the final product.

8. The preparation method according to claim 7, characterized in that, The first duration is 30-50 minutes; and / or, The second duration is 1-3 hours; and / or, The third duration is 1-3 hours; and / or, The fourth duration is 20-30 minutes; and / or, The fifth duration is 1-3 hours.

9. The traditional Chinese medicine composition according to claim 6, characterized in that, When the traditional Chinese medicine composition is in the form of granules, the traditional Chinese medicine composition is prepared by the following method: Weigh out each Chinese medicinal herb according to its weight percentage and mix them together; Add water and boil, combine the decoctions from each boiling, filter, and concentrate to obtain a concentrated liquid; The concentrate was further concentrated into an extract; After adding excipients to the extract, it is dried and pulverized to form dry extract powder; Add the excipients to the dry soaking powder again, mix well, and granulate to obtain the final product.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-9 in the preparation of a drug, characterized in that, The drug is used to prevent and / or treat symptoms of atrial arrhythmia, preferably palpitations, chest tightness, shortness of breath, fatigue, excessive sweating, dry mouth, irritability, or poor sleep associated with atrial arrhythmia.

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