Traditional Chinese medicine composition for treating tachyarrhythmia and preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating tachyarrhythmia and a preparation method and application thereof, and belongs to the field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 12-20 parts of codonopsis pilosula, 15-30 parts of astragalus membranaceus, 10-15 parts of angelica sinensis, 8-12 parts of ligusticum wallichii, 15-20 parts of tuber fleeceflower stem, 12-15 parts of poria with hostwood, 10-15 parts of ochre, 10-15 parts of nacre mother of pearl, 6-10 parts of ginger processed pinellia, 10-15 parts of poria cocos, 6-10 parts of rhizoma nardostachyos, 3-6 parts of subprostrate sophora, 1-3 parts of leech and 3-6 parts of raw liquorice. The traditional Chinese medicine composition provided by the invention is reasonable in compatibility, scientific in components, simple in preparation method, low in price, high in patient acceptability and convenient to take. Clinical tests prove that the traditional Chinese medicine composition is remarkable in curative effect on tachyarrhythmia, small in toxic and side effects and relatively high in economic and social benefits.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition for treating tachyarrhythmia, its preparation method and application. Background Art

[0002] Cardiovascular diseases, as the leading cause of death among Chinese residents, seriously endanger the health of residents. The latest data on the global burden of disease show that the incidence of various cardiovascular events, including atrial fibrillation and atrial flutter, has been continuously rising. By 2019, the age-standardized incidence has increased to 652.2 per 100,000 person-years. Tachyarrhythmia is a group of common clinical diseases, referring to the abnormal origin or conduction of cardiac impulses, resulting in a faster heart rate and rhythm disorder, including tachycardia, premature beats, atrial fibrillation, atrial flutter, etc. It is often induced by organic heart diseases or some non-organic heart diseases, and healthy people with disrupted work and rest or unstable emotions will also develop the disease. Tachyarrhythmia and diseases such as coronary heart disease, heart failure, stroke, and sudden death are mutually causal. Generally speaking, the older the age and the more complex the comorbidities, the higher the incidence and harm of tachyarrhythmia.

[0003] Western medicine treatments include antiarrhythmic drug treatments and non-drug treatments such as radiofrequency ablation and implantable cardioverter defibrillators. Recent data statistics show that the top three diseases with the highest surgical treatment rates for arrhythmia are atrial fibrillation / atrial flutter, atrial premature beats, and ventricular premature beats. Mild symptoms of premature beats and tachycardia are commonly treated with β-blockers or non-dihydropyridine calcium channel blockers, and atrial fibrillation is commonly treated with anticoagulants such as rivaroxaban. If the initial drug treatment fails, ablation is refused, unsuccessful, or considered inappropriate, then other anti-tumor drugs should be considered, and the prognostic risk and its proarrhythmic risk need to be evaluated. Any antiarrhythmic drug has an arrhythmogenic effect, and its adverse reaction incidence is high. At present, the research and treatment of arrhythmia diseases by Western medicine have entered a plateau stage, with a single drug target, lack of individualized treatment, high surgical risks, high recurrence rates, and high costs.

[0004] Patients with tachyarrhythmia experience palpitations and a fluttering feeling in the chest that cannot stop on their own. Traditional Chinese medicine classifies it into the categories of "palpitation" and "incessant throbbing". Compared with Western medicine treatment, traditional Chinese medicine treatment has many advantages such as overall regulation, syndrome differentiation and treatment, multiple targets, multiple pathways, and good safety. However, traditional Chinese medicine compositions often rely on syndrome differentiation for medication, the specific mechanism of action is not yet clear, the treatment effects vary, and there is a lack of clinical standardized treatment programs. Summary of the Invention

[0005] The object of the present invention is to provide a traditional Chinese medicine composition for treating tachyarrhythmia, its preparation method and application, so as to solve the problems existing in the above-mentioned prior art. The traditional Chinese medicine composition provided by the present invention has a significant curative effect on treating tachyarrhythmia, can reduce the attack frequency of premature beats, reduce the TCM syndrome integral of qi and blood deficiency syndrome, starting from the overall concept, significantly improve the quality of life of patients, and has small toxic and side effects, with remarkable economic and social benefits.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] The present invention provides a traditional Chinese medicine composition for treating tachyarrhythmia. Calculated by weight, the raw materials include the following components: 12-20 parts of Codonopsis pilosula, 15-30 parts of Astragalus membranaceus, 10-15 parts of Angelica sinensis, 8-12 parts of Ligusticum chuanxiong, 15-20 parts of Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew., 12-15 parts of Poria cum Radice Pini, 10-15 parts of Haematitum, 10-15 parts of Concha Margaritifera Usta, 6-10 parts of Pinellia ternata (Thunb.) Breit. with ginger juice, 10-15 parts of Poria cocos, 6-10 parts of Nardostachys jatamansi DC., 3-6 parts of Sophora subprostrata Chun ex S. Lee, 1-3 parts of Hirudo, and 3-6 parts of Glycyrrhiza uralensis Fisch.

[0008] Optionally, calculated by weight, the raw materials include the following components: 12 parts of Codonopsis pilosula, 30 parts of Astragalus membranaceus, 12 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 20 parts of Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew., 13 parts of Poria cum Radice Pini, 10 parts of Haematitum, 15 parts of Concha Margaritifera Usta, 6 parts of Pinellia ternata (Thunb.) Breit. with ginger juice, 15 parts of Poria cocos, 10 parts of Nardostachys jatamansi DC., 6 parts of Sophora subprostrata Chun ex S. Lee, 1 part of Hirudo, and 3 parts of Glycyrrhiza uralensis Fisch.

[0009] The present invention also provides a preparation method of the traditional Chinese medicine composition, including the following steps: decocting the raw materials with water, taking the filtrate to obtain the traditional Chinese medicine composition.

[0010] Optionally, the decocting includes:

[0011] Mixing Haematitum and Concha Margaritifera Usta with water for pre-decocting, then adding the remaining raw materials and water to continue decocting to obtain the first filter residue and the first filtrate;

[0012] Mixing the first filter residue with water for second decocting to obtain the second filter residue and the second filtrate;

[0013] Mixing the second filter residue with water for third decocting to obtain the third filter residue and the third filtrate;

[0014] Combining the first filtrate, the second filtrate and the third filtrate to obtain the traditional Chinese medicine composition.

[0015] Optionally, in the pre-decocting, the mass ratio of the total mass of Haematitum and Concha Margaritifera Usta to the mass of water is 1:(5-8); the time of the pre-decocting is 0.5-0.6 h.

[0016] Optionally, during the continued decocting, the mass ratio of the total mass of the raw medicinal materials other than hematite and nacreous mother-of-pearl to the mass of the water added again is 1:(5 - 8); the time for the continued decocting is 1.5 - 2 h.

[0017] Optionally, during the second decocting, the mass ratio of the first residue to water is 1:(5 - 8), and the time for the second decocting is 0.5 - 0.6 h.

[0018] Optionally, during the third decocting, the mass ratio of the second residue to water is 1:(5 - 8), and the time for the third decocting is 0.5 - 0.6 h.

[0019] The present invention also provides the use of the traditional Chinese medicine composition as described above or the traditional Chinese medicine composition prepared by the preparation method as described above in the preparation of a drug for treating tachyarrhythmia.

[0020] Optionally, the tachyarrhythmia includes paroxysmal atrial fibrillation and ventricular / supraventricular / atrial premature beats.

[0021] The present invention discloses the following technical effects:

[0022] The traditional Chinese medicine composition provided by the present invention takes "tonifying qi and nourishing blood, nourishing the heart and calming the mind, restoring the pulse and relieving palpitation" as the main treatment method, and also has the functions of promoting blood circulation to remove stasis, resolving phlegm, purging fire, and nourishing yin, and is mainly used for treating tachyarrhythmia of qi and blood deficiency type.

[0023] The traditional Chinese medicine composition provided by the present invention has reasonable compatibility, scientific components, simple preparation method, low price, high acceptance by patients, and convenient administration. Proven by clinical trials, the present invention has significant curative effect in treating tachyarrhythmia, can reduce the attack frequency of premature beats, lower the TCM syndrome integral of qi and blood deficiency syndrome, starting from the overall concept, significantly improve the quality of life of patients, and has small toxic and side effects, with great economic and social benefits. The present invention can also be applied to other tachyarrhythmias such as atrial fibrillation and tachycardia, and has wide clinical applications. Detailed implementation manners

[0024] The present invention provides a traditional Chinese medicine composition for treating tachyarrhythmia. By weight, the raw medicinal materials include the following components: 12 - 20 parts of Codonopsis pilosula, 15 - 30 parts of Astragalus membranaceus, 10 - 15 parts of Angelica sinensis, 8 - 12 parts of Ligusticum wallichii, 15 - 20 parts of Polygonum multiflorum Thunb. var. thomsonii (Mig.) Hoo & Tsai, 12 - 15 parts of Poria cum Radix Pini, 10 - 15 parts of hematite, 10 - 15 parts of nacreous mother-of-pearl, 6 - 10 parts of Pinellia ternata (Thunb.) Breit. var. purpurea (Schott) Hsiao & K. M. Feng, 10 - 15 parts of Poria cocos, 6 - 10 parts of Nardostachys jatamansi DC., 3 - 6 parts of Sophora subprostrata Chun ex S. Lee, 1 - 3 parts of Whitmania pigra Whitman, and 3 - 6 parts of Glycyrrhiza uralensis Fisch.

[0025] In the present invention, the Codonopsis pilosula, Astragalus membranaceus, Angelica sinensis, and Ligusticum wallichii are monarch drugs. Astragalus membranaceus and Codonopsis pilosula replenish qi, and Angelica sinensis and Ligusticum wallichii nourish blood and promote blood circulation, jointly achieving the effects of replenishing qi and generating blood, and restoring the pulse and relieving palpitation.

[0026] The polygonum multiflorum, poria, hematite and nacre are ministerial drugs. The polygonum multiflorum and poria soothe the heart and calm the mind, while the hematite and nacre suppress yang and calm fright, improving palpitation and insomnia.

[0027] The pinellia ternata, poria, nardostachys jatamansi and sophora subprostrata are adjuvant drugs. The pinellia ternata and poria resolve phlegm-dampness, the nardostachys jatamansi regulates qi and relieves depression, and a small amount of sophora subprostrata clears heat, achieving the effect of preventing phlegm stagnation from transforming into heat.

[0028] The leech promotes blood circulation and dredges collaterals, and can improve myocardial blood supply; the licorice nourishes yin and blood, and supplements qi and promotes yang. The two are used as envoy drugs together, restoring the pulse and calming palpitations, and coordinating all the drugs.

[0029] Tachyarrhythmia takes "deficiency of both qi and blood" as the key syndrome, "loss of nourishment of the mind" as the key pathogenesis, and is accompanied by pathological factors such as "phlegm", "stasis", "wind", "fire", etc. Therefore, the main treatment method is "tonifying qi and nourishing blood, nourishing the heart and calming the mind, restoring the pulse and calming palpitations", and also promoting blood stasis removal, resolving phlegm and purging fire. The traditional Chinese medicine composition provided by the present invention is summarized by the inventor based on traditional Chinese medicine theory and a large amount of effective data of clinical prescriptions, and has been objectively analyzed and verified. The prescription of this traditional Chinese medicine composition can exert the effects of tonifying qi and nourishing blood, calming the mind and relieving palpitations. It is used to treat patients with tachyarrhythmia of qi-blood deficiency type, showing symptoms such as palpitations, shortness of breath, fatigue, chest tightness, dizziness, insomnia, etc.

[0030] The present invention has no special limitation on the sources of the above raw materials, and conventional commercially available products well-known to those skilled in the art can be used.

[0031] The present invention also provides a preparation method of the above traditional Chinese medicine composition, including the following steps:

[0032] Weigh each raw material according to the above weight parts. Take hematite and nacre, mix them with water and pre-boil, then add other raw materials and water and continue boiling, separating the first filter residue and the first filtrate;

[0033] In some embodiments of the present invention, the mass ratio of the total mass of hematite and nacre to the mass of water is 1:(5 - 8); the mass ratio of the other raw materials to water is 1:(5 - 8); the pre-boiling time is 0.5 - 0.6 h; the continuous boiling time is 1.5 - 2 h;

[0034] Mix the first filter residue with water and boil for the second time, separating the second filter residue and the second filtrate; mix the second filter residue with water and boil for the third time, separating the third filter residue and the third filtrate; combine the first filtrate, the second filtrate and the third filtrate to obtain the traditional Chinese medicine composition;

[0035] In some specific embodiments of the present invention, the mass ratio of the first filter residue to water is 1:(5 - 8); the second boiling time is 0.5 - 0.6 h.

[0036] In some specific embodiments of the present invention, the mass ratio of the second filter residue to water is 1:(5 - 8); the time for the third decoction is 0.5 - 0.6 h.

[0037] The preparation method provided by the present invention can fully release the active ingredients in the traditional Chinese medicine composition into the decoction filtrate, improving the therapeutic effect.

[0038] The present invention also provides the use of the above traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above preparation method in the preparation of a drug for treating tachyarrhythmia.

[0039] Now, various exemplary embodiments of the present invention will be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, characteristics, and implementation manners of the present invention.

[0040] It should be understood that the terms used in the present invention are only for describing specific implementation manners and are not used to limit the present invention. Additionally, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0041] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention pertains. Although the present invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0042] Without departing from the scope or spirit of the present invention, various improvements and changes can be made to the specific implementation manners of the present invention specification, which are obvious to those skilled in the art. Other implementation manners obtained from the present invention specification are obvious to those skilled in the art. The present invention specification and examples are only exemplary.

[0043] Regarding the use of "comprising", "including", "having", "containing", etc. herein, they are all open-ended terms, meaning including but not limited to.

[0044] Example 1

[0045] A traditional Chinese medicine composition for treating tachyarrhythmia, by weight, the raw materials include the following components:

[0046] 20 parts of Codonopsis pilosula, 20 parts of Astragalus membranaceus, 10 parts of Angelica sinensis, 8 parts of Ligusticum wallichii, 18 parts of Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew., 12 parts of Poria cum Radix Pini, 15 parts of Haematitum, 10 parts of Concha Margaritifera Usta, 8 parts of Pinellia ternata (Thunb.) Breit. with ginger juice, 10 parts of Poria cocos, 8 parts of Nardostachys jatamansi DC., 5 parts of Sophora subprostrata Chun et T. Chen, 2 parts of Whitmania pigra Whitman, and 4 parts of Glycyrrhiza uralensis Fisch.

[0047] The preparation method is as follows:

[0048] Weigh each raw material medicine according to the above weight parts, 20 g of Codonopsis pilosula, 20 g of Astragalus membranaceus, 10 g of Angelica sinensis, 8 g of Ligusticum wallichii, 18 g of Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew., 12 g of Poria cum Radix Pini, 15 g of Haematitum, 10 g of Concha Margaritifera Usta, 8 g of Pinellia ternata (Thunb.) Breit. with ginger juice, 10 g of Poria cocos, 8 g of Nardostachys jatamansi DC., 5 g of Sophora subprostrata Chun et T. Chen, 2 g of Whitmania pigra Whitman, and 4 g of Glycyrrhiza uralensis Fisch.

[0049] Take Haematitum and Concha Margaritifera Usta, add water and decoct for 0.5 h according to the material-liquid ratio of 1:6 (m / m), then add other raw material medicines and water (other raw material medicines: water = 1:8, m / m), and continue to decoct for 2 h, separate the first filter residue and the first filtrate;

[0050] Mix the first filter residue with 6 times the mass of water and decoct for 0.5 h, separate the second filter residue and the second filtrate;

[0051] Mix the second filter residue with 6 times the mass of water and decoct for 0.5 h, separate the third filter residue and the third filtrate;

[0052] Combine the first filtrate, the second filtrate and the third filtrate to obtain the traditional Chinese medicine composition.

[0053] Example 2

[0054] A traditional Chinese medicine composition for treating tachyarrhythmia, calculated by weight, the raw material medicines include the following components:

[0055] 12 parts of Codonopsis pilosula, 30 parts of Astragalus membranaceus, 12 parts of Angelica sinensis, 10 parts of Ligusticum wallichii, 20 parts of Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew., 13 parts of Poria cum Radix Pini, 10 parts of Haematitum, 15 parts of Concha Margaritifera Usta, 6 parts of Pinellia ternata (Thunb.) Breit. with ginger juice, 15 parts of Poria cocos, 10 parts of Nardostachys jatamansi DC., 6 parts of Sophora subprostrata Chun et T. Chen, 1 part of Whitmania pigra Whitman, and 3 parts of Glycyrrhiza uralensis Fisch.

[0056] The preparation method is as follows:

[0057] Weigh each raw material medicine according to the above weight parts, 12 g of Codonopsis pilosula, 30 g of Astragalus membranaceus, 12 g of Angelica sinensis, 10 g of Ligusticum wallichii, 20 g of Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew., 13 g of Poria cum Radix Pini, 10 g of Haematitum, 15 g of Concha Margaritifera Usta, 6 g of Pinellia ternata (Thunb.) Breit. with ginger juice, 15 g of Poria cocos, 10 g of Nardostachys jatamansi DC., 6 g of Sophora subprostrata Chun et T. Chen, 1 g of Whitmania pigra Whitman, and 3 g of Glycyrrhiza uralensis Fisch.

[0058] Take Haematitum and Concha Margaritifera Usta, add water and decoct for 0.6 h according to the material-liquid ratio of 1:5 (m / m), then add other raw material medicines and water (other raw material medicines: water = 1:6, m / m), and continue to decoct for 1.5 h, separate the first filter residue and the first filtrate;

[0059] Mix the first filter residue with water at 5 times its mass and decoct for 0.6 h, then separate the second filter residue and the second filtrate;

[0060] Mix the second filter residue with water at 5 times its mass and decoct for 0.6 h, then separate the third filter residue and the third filtrate;

[0061] Combine the first filtrate, the second filtrate and the third filtrate to obtain the traditional Chinese medicine composition.

[0062] Example 3

[0063] A traditional Chinese medicine composition for treating tachyarrhythmia, calculated by weight, the raw materials include the following components:

[0064] 17 parts of Codonopsis pilosula, 15 parts of Astragalus membranaceus, 15 parts of Angelica sinensis, 12 parts of Ligusticum chuanxiong, 15 parts of Polygonum multiflorum Thunb. var. caudatum, 15 parts of Poria cum Radice Pini, 12 parts of Haematitum, 12 parts of Concha Margaritifera Usta, 10 parts of Pinellia ternata, 12 parts of Poria, 6 parts of Nardostachys jatamansi, 3 parts of Sophora subprostrata, 3 parts of Hirudo and 6 parts of Glycyrrhiza uralensis Fisch..

[0065] The preparation method is as follows:

[0066] Weigh each raw material according to the above weight parts, 17 g of Codonopsis pilosula, 15 g of Astragalus membranaceus, 15 g of Angelica sinensis, 12 g of Ligusticum chuanxiong, 15 g of Polygonum multiflorum Thunb. var. caudatum, 15 g of Poria cum Radice Pini, 12 g of Haematitum, 12 g of Concha Margaritifera Usta, 10 g of Pinellia ternata, 12 g of Poria, 6 g of Nardostachys jatamansi, 3 g of Sophora subprostrata, 3 g of Hirudo and 6 g of Glycyrrhiza uralensis Fisch..

[0067] Take Haematitum and Concha Margaritifera Usta, add water and decoct for 0.6 h according to the ratio of material to liquid 1:8 (m / m), then add other raw materials and water (other raw materials: water = 1:8, m / m), and continue to decoct for 1.5 h, then separate the first filter residue and the first filtrate;

[0068] Mix the first filter residue with water at 8 times its mass and decoct for 0.6 h, then separate the second filter residue and the second filtrate;

[0069] Mix the second filter residue with water at 8 times its mass and decoct for 0.6 h, then separate the third filter residue and the third filtrate;

[0070] Combine the first filtrate, the second filtrate and the third filtrate to obtain the traditional Chinese medicine composition.

[0071] Application Example 1

[0072] I. Case source and grouping

[0073] 1. The cases were sourced from outpatients in the Department of Cardiology, Affiliated Hospital of Changchun University of Traditional Chinese Medicine from August 2023 to August 2024. The Western medicine diagnosis was ventricular / supraventricular / atrial premature beats, and the traditional Chinese medicine syndrome diagnosis was qi and blood deficiency syndrome. A total of 64 patients were included. A random number grouping table was generated according to the case serial numbers using the random number table method. The patients were divided into a control group of 16 cases and experimental groups 1 - 3 of 16 cases each.

[0074] 2. Diagnostic criteria:

[0075] The diagnostic criteria for premature beats of arrhythmia refer to "Dynamic Electrocardiography"; the diagnostic criteria for qi and blood deficiency syndrome refer to "Traditional Chinese Medicine Diagnosis".

[0076] 3. Inclusion criteria

[0077] Meeting the electrocardiogram diagnostic criteria for the disease; meeting the traditional Chinese medicine syndrome diagnostic criteria; aged between 35 and 80 years old; signing the informed consent form.

[0078] 4. Exclusion criteria

[0079] Those under 35 years old or over 80 years old; pregnant or lactating women; patients with allergic constitution and allergic to this medicine; those with severe primary diseases such as cerebrovascular, liver, kidney, and hematopoietic systems and severe cardiac function disorders; those with mental illness; severe bradycardia (heart rate < 50 beats / min), conduction block (above second degree type II) or long pause; arrhythmia caused by drugs such as digitalis, electrolyte disorders, and thyroid function abnormalities; treatment interruption, refusal to review, or loss of contact. Exclusion will be made if any of the above does not meet the criteria.

[0080] 5. Exclusion criteria

[0081] Those who did not take medicine according to the established plan; those who had severe adverse reaction events; those who were lost to follow-up or did not visit on time; those who actively interrupted the trial. Exclusion will be made if any of the above occurs.

[0082] II. Research methods:

[0083] 1. Treatment measures:

[0084] The control group was given metoprolol succinate sustained-release tablets at 23.75 mg - 47.5 mg once a day; experimental groups 1 - 3 were respectively given the traditional Chinese medicine composition decoction prepared in Examples 1 - 3 in combination with metoprolol succinate sustained-release tablets. The method of taking the traditional Chinese medicine decoction: 150 mL each time, twice a day. For those with combined other diseases, Western medicine standardized treatment was carried out. 14 days was a treatment cycle, and 1 - 3 cycles were observed.

[0085] 2. Efficacy observation:

[0086] Observation items: 24-hour dynamic electrocardiogram, traditional Chinese medicine syndrome score, each done once before and after treatment.

[0087] 3. Efficacy evaluation criteria:

[0088] (1) The number of ventricular / supraventricular / atrial premature beats is formulated with reference to the "Recommendations on the Evaluation Methods of Cardiovascular Drug Clinical Trials": ① Marked effect: The number of premature contractions in 24 hours is reduced by ≥90% compared with that before treatment; ② Effective: The number of premature contractions in 24 hours is ≥50% and <90% compared with that before treatment; ③ Ineffective: The number of premature contractions in 24 hours is reduced by <50% compared with that before treatment, without change or aggravated.

[0089] (2) The criteria for judging the efficacy of traditional Chinese medicine syndromes are formulated with reference to the "Clinical Guidelines for New Traditional Chinese Medicines" in 2002: ① Marked effect: The clinical symptoms and signs of traditional Chinese medicine are significantly improved, and the syndrome score is reduced by ≥70%; ② Effective: The clinical symptoms and signs of traditional Chinese medicine are improved, and the syndrome score is reduced by ≥30% and <70%; ③ Ineffective: The clinical symptoms and signs of traditional Chinese medicine are not significantly improved, and the syndrome score is reduced by <30%. The total effective rate of treatment = (the number of marked effect cases + the number of effective cases) / the total number of patients × 100%.

[0090] (3) The criteria for judging the total efficacy of ventricular / supraventricular / atrial premature beats: ① Clinical cure: All symptoms disappear; the dynamic electrocardiogram examination returns to normal; ② Marked effect: The palpitation symptoms disappear, and the dynamic electrocardiogram is significantly improved; the number of premature beats is reduced by 70% compared with that before treatment; ③ Effective: Most of the palpitation symptoms disappear, and the dynamic electrocardiogram is improved; the number of premature beats is reduced by 30%-70% compared with that before treatment; ④ Ineffective: The palpitation symptoms and the dynamic electrocardiogram have no change or are aggravated, and the number of premature beats is reduced by <30% compared with that before treatment.

[0091] 4. Statistical methods: The spss25.0 statistical software is used to analyze the count data and categorical data through the chi-square test, and the measurement data, within-group data, and between-group data are compared and analyzed through the t-test and rank sum test.

[0092] 5. Safety: During the trial, general indicators such as the heart rhythm, heart rate, and blood pressure of the patients are recorded once every 2 weeks; before and after treatment, the safety indicators of the enrolled patients such as blood routine, liver and kidney functions are detected.

[0093] III. Research results

[0094] 1. General situation

[0095] During the trial, the general information of experimental groups 1-3 and the control group is shown in Table 1.

[0096] Table 1 General information

[0097]

[0098] Among the subjects who finally completed the trial, the longest disease course was 20 years, and the shortest was 1 month. There were 28 cases complicated with hypertension, 11 cases with coronary heart disease, 14 cases with autonomic nerve disorder, 8 cases with anxiety state, 7 cases with other diseases, and 4 cases without complications. The test indexes such as blood routine, liver and kidney function of each group of patients before and after treatment were normal, and no adverse reactions occurred in both groups.

[0099] 2. Comparison of ambulatory electrocardiograms of patients in different groups after treatment

[0100] The comparison of the curative effects of ambulatory electrocardiograms of patients in different groups after treatment is shown in Table 2. After treatment, the comparison of ambulatory electrocardiograms showed that the total effective rates of Treatments 1 - 3 in the experimental group reached 81.25% - 87.5%, which was significantly higher than that of the control group (64.28%).

[0101] Table 2 Comparison of the curative effects of ambulatory electrocardiograms after treatment

[0102]

[0103] Note: P = 0.015 < 0.05.

[0104] 3. Comparison of the curative effects of traditional Chinese medicine syndromes of patients in different groups after treatment

[0105] The comparison of the curative effects of traditional Chinese medicine syndromes of patients in different groups after treatment is shown in Table 3. After treatment, the comparison of traditional Chinese medicine syndromes showed that the total effective rates of Treatments 1 - 3 in the experimental group reached 87.5% - 93.75%, which was significantly better than that of the control group (71.42%)

[0106] Table 3 Comparison of the curative effects of traditional Chinese medicine syndromes of patients in different groups after treatment

[0107]

[0108] Note: P = 0.005 < 0.05.

[0109] Application Example 2

[0110] I. Case source and grouping

[0111] 1. The cases were from the outpatients in the Department of Cardiology, Affiliated Hospital of Changchun University of Chinese Medicine from August 2023 to August 2024. The western medicine diagnosis was paroxysmal atrial fibrillation, and the traditional Chinese medicine syndrome diagnosis was qi and blood deficiency syndrome. A total of 120 patients were included. A random number grouping table was generated according to the case serial numbers by using the random number table method, and the patients were divided into a control group of 30 cases and experimental groups 1 - 3 of 30 cases each.

[0112] 2. Diagnostic criteria:

[0113] Refer to the relevant standards for the diagnosis and classification of atrial fibrillation in the "2024 ESC / EACTS Guidelines for the Management of Atrial Fibrillation".

[0114] The diagnosis of atrial fibrillation is mainly based on electrocardiogram. Its specific manifestations during an attack are as follows: the P wave disappears and is replaced by "f" waves with irregular morphology, size, and duration; the frequency of the f waves is 350 - 600 beats / min, and the R-R intervals are absolutely unequal; the QRS wave pattern is mostly normal, but it can also be wide and abnormal.

[0115] Paroxysmal atrial fibrillation usually restores sinus rhythm within 7 days, and the vast majority restores sinus rhythm within 24 hours and can convert to sinus rhythm spontaneously.

[0116] 3. Inclusion criteria

[0117] Ages between 18 and 85 years old, regardless of gender; paroxysmal atrial fibrillation (onset time > 48 hours); no obvious hemodynamic disorders; all atrial fibrillation patients are high-risk patients with a CHA2DS2-VASc score of ≥ 2 points for men and ≥ 3 points for women; meeting the diagnostic criteria of qi and blood deficiency syndrome in traditional Chinese medicine; voluntary subjects who understand and sign the informed consent form.

[0118] 4. Exclusion criteria

[0119] Valvular heart disease (rheumatic mitral stenosis, mechanical / biological valve replacement, mitral valve repair, etc.);

[0120] Congenital heart disease (patent foramen ovale, atrial septal defect, atrial septal aneurysm, etc.); Wolff-Parkinson-White syndrome, atrioventricular block, sick sinus syndrome; those with heart function above grade III; those with severe hepatic and renal insufficiency; those with mental illness; pregnant and lactating women; those with drug allergies; those considered unsuitable for clinical trials in the study.

[0121] 5. Withdrawal criteria

[0122] Those who have allergic reactions or severe adverse events; during the trial, the subjects have abnormal liver and kidney functions, and it is considered related to the drug; the subjects have poor compliance (medication ≤ 80%, or automatically change medications midway, or add any traditional Chinese or Western medicines on their own without following the doctor's advice); cases of unblinding midway for various reasons; regardless of the reason, patients are unwilling or unable to continue the clinical trial and request to withdraw from the trial to the attending doctor; those who are lost to follow-up although they do not explicitly request to withdraw from the trial but no longer accept medication and follow-up tests.

[0123] 6. Exclusion criteria

[0124] Those who violate the inclusion criteria or exclusion criteria; those who have not taken medications after randomization; others.

[0125] 7. Grouping

[0126] Using the randomized block method, the case patients were randomly assigned to the control group (β-blockers, non-dihydropyridine calcium antagonists; NOAC drugs such as rivaroxaban and edoxaban; conventional Western medicines such as aspirin or clopidogrel), experimental group 1 (conventional Western medicine + traditional Chinese medicine composition of Example 1), experimental group 2 (conventional Western medicine + traditional Chinese medicine composition of Example 2), and experimental group 3 (conventional Western medicine + traditional Chinese medicine composition of Example 3) in a ratio of 1:1:1:1. By using the PROCPLNA procedure statement of SAS statistical software, a random arrangement (i.e., a random coding table) of the treatments (experimental drugs and control drugs) to be received by the subjects to be enrolled was generated. The randomization plan was specifically managed by the personnel in the research group who did not participate in the clinical trial.

[0127] 8. Study Drugs

[0128] The traditional Chinese medicine compositions prepared in Examples 1-3 were concentrated at a low temperature of 60-70°C and spray-dried into powder. 1 bag each time, 2 times a day, to be taken after brewing.

[0129] 9. Observation Indicators

[0130] 9.1 Heart Rate Tracking Indicators

[0131] (1) Electrocardiogram (EKG): It was detected at the time of enrollment, cardioversion, atrial fibrillation recurrence, 1 month, and 3 months respectively. The cardioversion duration and the duration of maintaining sinus rhythm after cardioversion were recorded.

[0132] (2) Ambulatory electrocardiogram (Holter): The atrial fibrillation attack frequency and atrial high-frequency events (AHRE) were recorded. It was detected at 0 month, 1 month, and 3 months after enrollment.

[0133] 9.2 Evaluation of the Efficacy of Traditional Chinese Medicine Syndromes

[0134] The efficacy of traditional Chinese medicine syndromes was determined according to the scoring method: efficacy index (n) = ((pre-treatment score - post-treatment score) / pre-treatment score) × 100%.

[0135] (1) Marked effect: Clinical symptoms and signs were significantly improved, and the syndrome score was reduced by ≥70%.

[0136] (2) Effective: Clinical symptoms and signs were improved, and the syndrome score was reduced by ≥30%.

[0137] (3) Ineffective: Clinical symptoms and signs were not significantly improved, and the syndrome score was reduced by <30%.

[0138] 10. Statistical Processing

[0139] Analysis was performed using SPSS 21.0 statistical analysis software. Constituent ratios were used to describe categorical data, mean ± standard deviation was used to describe measurement data, and median and percentiles were used to describe non-normally distributed data. Independent samples t-tests were used for measurement data that followed a normal distribution, and non-parametric analysis was used for non-normally distributed measurement data. Independent samples t-tests were used for between-group comparisons of the baseline, post-treatment, and differences before and after treatment of the symptom scores and rates in the two groups; paired t-tests were used for within-group comparisons before and after treatment. The chi-square test was used to analyze the differences in the constituent ratios of the curative effects between the two groups, and Ridit analysis was used to analyze the differences between qualitative data and quantitative data such as treatment methods and curative effects. A statistical difference was considered when P < 0.05.

[0140] II. Results

[0141] 1. Comparison of clinical data

[0142] Table 4 Comparison of clinical data in different groups

[0143]

[0144] Finally, 29 patients in the control group, 130 patients in experimental group 1, and 29 patients each in experimental group 2 and experimental group 3 were included in the efficacy evaluation through random grouping. There were no significant differences in the clinical baseline characteristics among the groups, indicating comparability (Table 4).

[0145] 2. Comparison of TCM syndrome scores before and after treatment in each group

[0146] Table 5 TCM syndrome scores before and after treatment in each group

[0147]

[0148] Note: * represents p < 0.05 compared with the control group.

[0149] Table 5 showed that there were significant differences in the syndrome scores of experimental groups 1 - 3 at 3 months after treatment compared with those before treatment, and they decreased significantly more than those in the control group.

[0150] 3. Comparison of the maintenance rate of sinus rhythm and resting heart rate before and after treatment in each group

[0151] Table 6 Comparison of the maintenance rate of sinus rhythm before and after treatment in each group (%)

[0152]

[0153] Note: * indicates a significant difference compared with the control group at the same time point (p < 0.05).

[0154] Table 7 Comparison of resting heart rate before and after treatment in each group (beats / min)

[0155]

[0156] Note: * indicates significant difference compared with the control group during the same period (p<0.05).

[0157] In patients with paroxysmal atrial fibrillation, the 1-3 sinus rhythm maintenance rate in the experimental group was significantly higher than that in the control group at 0, 1, and 3 months of treatment (P < 0.05); the resting heart rate began to decrease significantly after 1 month of treatment, and decreased significantly after 3 months of treatment (P < 0.05). The resting heart rate of the control group decreased after 3 months of treatment, but the difference was not significant.

[0158] Effect Example 1

[0159] Zhu, female, 43 years old, visited the hospital on February 27, 2024 due to "palpitations for 1 year, aggravated for 7 days".

[0160] Current medical history: palpitations occurred 1 year ago due to fatigue and emotional fluctuations. He had taken "Metoprolol Tartrate Sustained Release Tablets" and the symptoms improved. 7 days ago, the palpitations worsened without obvious cause. The 24-hour dynamic electrocardiogram showed: frequent ventricular premature contractions, 13896 times / 24h; paroxysmal bigeminy and trigeminy; atrial premature contractions 921 times / 24h. Taking Betaloc did not improve the condition significantly, so he went to the outpatient clinic of the Affiliated Hospital of Changchun University of Chinese Medicine for treatment.

[0161] Current symptoms: palpitations, shortness of breath, fatigue, dizziness, poor sleep, easy awakening, dry mouth, no bitter taste, sweating, usually irritable, good appetite, good urination, unformed stool. Dark and fat tongue, thick white fur, intermittent pulse. Small menstrual volume, dark color, regular menstruation. History of hypertension for 3 years, the highest 145 / 101mmHg, taking irbesartan and amlodipine besylate, self-conscious control is unstable; hyperlipidemia for one year. Examination: blood pressure 115 / 86mmHg, heart rate 93 beats / min.

[0162] Western medicine diagnosis: hypertension; arrhythmia - frequent ventricular premature beats and atrial premature beats; Chinese medicine diagnosis: palpitations and deficiency of qi and blood.

[0163] Standardized Western medicine treatment: 150 mg of irbesartan was taken orally in the morning, and 10 mg of Almar was taken orally in the morning and evening; the Chinese medicine composition of Example 1 was added with 25 g of Bupleurum, 10 g of Curcuma, and 10 g of Albizzia julibrissin, 10 packs, and the Chinese medicine decoction was obtained according to the above preparation method. About 150 mL was taken 30 minutes after lunch and 30 minutes after dinner.

[0164] After taking the traditional Chinese medicine decoction for more than half a month, the patient had a follow-up visit on March 10, 2024. The patient reported that all symptoms had improved, palpitations had significantly reduced, sleep had improved, and the patient felt physically and mentally happy. The blood pressure was measured at 125 / 82 mmHg, and the heart rate was 73 beats per minute. The tongue was pale and plump, the tongue coating was white, and the pulse was slow. The patient was instructed to stop taking metoprolol and continue taking the above-mentioned medicine for 10 doses. The third follow-up visit was on March 24, 2024: The results of the 24-hour ambulatory electrocardiogram showed: frequent ventricular premature contractions, 1,668 times / 24h; occasional bigeminy and trigeminy; atrial premature contractions 25 times / 24h. The blood pressure was measured at 121 / 79 mmHg, and the heart rate was 68 beats per minute. Premature beats were not palpable. The tongue was pale and plump, and the tongue coating was thin and white. The patient was instructed to take Shensong Yangxin Capsules and take antihypertensive drugs regularly.

[0165] Comment: This patient usually has an impatient temperament. Therefore, on the basis of using the traditional Chinese medicine composition for treating premature beats of the present invention, three herbs, Bupleurum chinense, Curcuma aromatica, and Cortex Albiziae, are added to soothe the liver and relieve depression, regulate emotions, and smooth qi movement, which is helpful for improving the condition. Especially for female patients aged 35-55 with high mental stress, they are prone to accompany anxiety and autonomic nerve disorders. Therefore, some herbs for soothing the liver and relieving depression are often added in clinical practice.

[0166] Effect Example 2

[0167] Zhao, male, 38 years old, visited the doctor on March 12, 2024 due to "palpitations for 5 years, aggravated with attacks for 2 months".

[0168] Current medical history: The patient reported that the above symptoms occurred after fatigue, accompanied by fear of heat, shortness of breath, fatigue, dizziness, chest tightness, poor appetite, heart discomfort after eating a lot, bitter taste in the mouth, poor sleep, difficulty falling asleep, yellow urine, and dry stools like sheep dung, once every 1-2 days. The tongue was dark and plump, the tongue coating was white, with cracks, and the pulse was slow. The patient had a history of atrial fibrillation radiofrequency ablation 6 months ago; fatty liver for 4 years. Auxiliary examinations: 24-hour ambulatory electrocardiogram (August 13, 2023): atrial fibrillation with rapid ventricular rate. Electrocardiogram (February 27, 2024): normal electrocardiogram. Digestive color Doppler ultrasound: fatty liver; intrahepatic calcification; gallbladder stones.

[0169] Western medicine diagnosis: arrhythmia - after atrial fibrillation radiofrequency ablation; autonomic nerve disorder. Traditional Chinese medicine diagnosis: palpitations with qi and blood deficiency syndrome.

[0170] For traditional Chinese medicine treatment, the composition in Example 2 was compounded with 15 g of Rehmannia glutinosa, 15 g of Paeonia suffruticosa, and 15 g of Alisma orientale, and 10 doses were given. The traditional Chinese medicine decoction was obtained according to the above preparation method and about 150 mL was taken 30 minutes after lunch and 30 minutes after dinner respectively.

[0171] After taking the traditional Chinese medicine decoction for more than half a month, the patient had a follow-up visit on May 6, 2024. The patient reported that all symptoms had improved, atrial fibrillation had not occurred, palpitations had significantly improved, the bitter taste in the mouth had disappeared, and sleep was good.

[0172] Note: This patient had ineffective recurrence after radiofrequency ablation for atrial fibrillation. The electrocardiogram was normal, but symptoms such as poor sleep, irritability, frequent palpitations, and obvious fatigue significantly reduced the patient's quality of life. Over time, due to deficiency of heart qi and blood and insufficient yin fluid, internal heat was generated, resulting in bitter taste in the mouth, yellow urine, and dry stools. Therefore, the syndrome was differentiated as qi and blood deficiency syndrome with yin deficiency and excessive fire. Herbs such as Rehmannia glutinosa, Moutan cortex, and Alisma orientale were added to nourish yin and moisten dryness, clear heat and purge fire.

[0173] Effect Example 3

[0174] Yang, female, 47 years old, visited the doctor on May 3, 2024 due to "palpitations accompanied by shortness of breath for 1 month".

[0175] Current medical history: accompanied by sweating, the above symptoms aggravated after activity, poor sleep, difficulty falling asleep, taking eszopiclone to aid sleep, loose stools, pale red, plump and enlarged tongue with tooth marks on the sides, greasy tongue coating, and deep and thready pulse. Heart rate: 91 beats per minute. Auxiliary examinations: 24-hour ambulatory electrocardiogram: sinus arrhythmia; atrial premature beats; ventricular premature beats, 2295 times / 24h, accompanied by trigeminy. Coronary CTA: negative.

[0176] Western medicine diagnosis: arrhythmia - frequent ventricular premature beats; autonomic nerve disorder; anxiety state. Traditional Chinese medicine diagnosis: palpitations with qi and blood deficiency syndrome.

[0177] For the traditional Chinese medicine treatment, 15 g of dried tangerine peel was added to the composition compound in Example 3, and 10 doses were prepared. The traditional Chinese medicine decoction was obtained according to the above preparation method and about 150 mL was taken 30 minutes after lunch and 30 minutes after dinner respectively.

[0178] After taking the traditional Chinese medicine decoction for more than half a month, the patient visited the doctor again on May 17, 2024, stating that all symptoms had improved. On physical examination, no premature beats were found, heart rate: 79 beats per minute. There was still occasional shortness of breath, sighing frequently, thick and greasy white tongue coating, and deep and slow pulse. Treatment: 20 g of Astragalus membranaceus, 25 g of Bupleurum chinense, 15 g of Curcuma aromatica, and 10 g of Albizia julibrissin were added according to the previous prescription. On May 31, 2024, the patient visited the doctor again, stating that the premature beats had disappeared, heart rate: 67 beats per minute. The 24-hour ambulatory electrocardiogram was rechecked: 12 ventricular premature beats / 24 hours.

[0179] Note: According to the comprehensive clinical manifestations, the syndrome of this patient was differentiated as qi and blood deficiency syndrome in traditional Chinese medicine. However, at the same time, the patient had severe sweating, thick and greasy tongue coating with tooth marks on the sides, and severe anxiety, presenting symptoms of spleen deficiency with dampness accumulation. Therefore, dried tangerine peel was differentiated to strengthen the spleen, eliminate dampness, and resolve phlegm. For those with obvious qi deficiency, Astragalus membranaceus was added to tonify the lung, spleen, and heart qi, and Bupleurum chinense, Curcuma aromatica, and Albizia julibrissin were added to soothe the liver qi.

[0180] In summary, the traditional Chinese medicine composition of the present invention has reasonable compatibility, scientific components, simple preparation method, low price, high patient acceptance and convenient administration. Proven by clinical trials, the present invention has significant curative effect on treating paroxysmal tachyarrhythmia, can reduce the attack frequency of premature beats, lower the TCM syndrome integral of qi and blood deficiency syndrome, and starting from the overall concept, significantly improve the quality of life of patients, with small toxic and side effects and huge economic and social benefits. The present invention can also be applied to other paroxysmal tachyarrhythmias such as atrial fibrillation and tachycardia, and has wide clinical applications.

[0181] The embodiments described above are only used to describe the preferred embodiments of the present invention, rather than to limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating tachyarrhythmia, characterized in that: By weight, the raw materials include the following components: 12-20 parts of Codonopsis pilosula, 15-30 parts of Astragalus, 10-15 parts of Angelica sinensis, 8-12 parts of Ligusticum chuanxiong, 15-20 parts of Polygonum multiflorum, 12-15 parts of Poria, 10-15 parts of ochre, 10-15 parts of mother-of-pearl, 6-10 parts of Pinellia ternata, 10-15 parts of Poria, 6-10 parts of Nardostachys grandiflora, 3-6 parts of Sophora flavescens, 1-3 parts of Leech and 3-6 parts of raw licorice.

2. The Chinese medicine composition according to claim 1, characterized in that: By weight, the raw materials include the following components: 12 parts of Codonopsis pilosula, 30 parts of Astragalus membranaceus, 12 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 20 parts of Polygonum multiflorum, 13 parts of Poria, 10 parts of ochre, 15 parts of mother-of-pearl, 6 parts of Pinellia ternata, 15 parts of Poria, 10 parts of Nardostachys grandiflora, 6 parts of Sophora flavescens, 1 part of Leech and 3 parts of raw licorice.

3. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: The raw material medicine is decocted with water, and the filtrate is taken to obtain a traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that: The decoction comprises: Mixing ochre and mother-of-pearl with water and pre-decocting, then adding the remaining raw materials and water and continuing to decoct to obtain a first filter residue and a first filtrate; The first filter residue is mixed with water and then subjected to a second decoction to obtain a second filter residue and a second filtrate; The second filter residue is mixed with water and then boiled for a third time to obtain a third filter residue and a third filtrate; The first filtrate, the second filtrate and the third filtrate are combined to obtain the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that: In the pre-decoction, the mass ratio of the total mass of ochre and mother-of-pearl to the mass of water is 1:(5-8); and the pre-decoction time is 0.5-0.6h.

6. The preparation method according to claim 4, characterized in that: During the continued decoction, the mass ratio of the total mass of the remaining raw materials except ochre and mother-of-pearl to the mass of the water added again is 1:(5-8); the time for the continued decoction is 1.5-2h.

7. The preparation method according to claim 4, characterized in that: In the second decoction, the mass ratio of the first filter residue to water is 1:(5-8), and the time of the second decoction is 0.5-0.6h.

8. The preparation method according to claim 4, characterized in that: In the third decoction, the mass ratio of the second filter residue to water is 1:(5-8), and the time of the third decoction is 0.5-0.6h.

9. Use of the Chinese medicine composition according to claim 1 or 2 or the Chinese medicine composition prepared by the preparation method according to any one of claims 3 to 8 in preparing a drug for treating tachyarrhythmia.

10. The use according to claim 9, characterized in that: The tachyarrhythmias include paroxysmal atrial fibrillation and ventricular / supraventricular / atrial premature beats.

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