Traditional Chinese medicine preparation for treating bradyarrhythmia

Abstract

The present invention discloses a traditional Chinese medicine preparation for treating bradyarrhythmia, which is prepared from the following raw materials: 10-20 g of ephedra, 25-35 g of black aconite root, 10-20 g of asarum, 25-35 g of processed Chuanwu, 25-35 g of cinnamon twig, 8-12 g of roasted liquorice root, 25-35 g of raw white atractylodes, 25-35 g of raw astragalus, 25-35 g of dried ginger, 10-20 g of cinnamon bark, 15-25 g of pinellia tuber, 8-12 g of ginseng, and 25-35 g of antler frost. The traditional Chinese medicine preparation for treating bradyarrhythmia of the present invention is taken orally during treatment, one dose per day, divided into two doses, and a course of treatment of 4 weeks. The traditional Chinese medicine preparation for treating bradyarrhythmia of the present invention can significantly improve the clinical symptoms of patients, significantly improve the symptoms of palpitations and anxiety of patients, restore the electrocardiogram to normal or significantly improve, has significant efficacy, good safety, and has high clinical promotion value.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine preparation for treating bradyarrhythmia, belonging to the technical field of traditional Chinese medicine preparations. Background Art

[0002] Bradyarrhythmia (BA) refers to various arrhythmias with an effective heart rate below 60 beats per minute, including sinus bradycardia, sinoatrial block, sick sinus syndrome, atrioventricular block, and intraventricular block. A decreased heart rate and chronotropic insufficiency can lead to insufficient blood supply to organs such as the brain, heart, and kidneys, and even hemodynamic changes. Clinical manifestations include decreased exercise tolerance, palpitations, chest tightness, and fatigue. Severe cases can cause blackouts, transient loss of consciousness, syncope, and even death.

[0003] Currently, the most effective treatment for bradyarrhythmias in Western medicine is modern medicine's pacemaker implantation therapy, which essentially cures patients' arrhythmias after surgery. However, pacemaker treatment is expensive, the battery and wire lifespan is limited, and long-term program maintenance is required. Therefore, the treatment is difficult to popularize, and many patients still choose conservative treatment. In terms of drug treatment, the combination of Chinese and Western medicine is a commonly used method in clinical practice. Western medicine can quickly increase heart rate, but this effect is not long-lasting and requires long-term medication. However, the current clinical use of conventional Western medicines such as atropine, aminophylline, and isoproterenol has many adverse reactions and is difficult to control the dosage, making it difficult to use for the long-term treatment of bradyarrhythmias.

[0004] Bradyarrhythmias, as defined in Traditional Chinese Medicine (TCM), fall under the categories of palpitations, fright, and anxiety. Traditional Chinese medicine (TCM) offers advantages in treating bradyarrhythmias. TCM treatment is highly safe and can effectively elevate heart rate and improve bradycardia-related symptoms such as palpitations and fatigue. For non-critically ill patients, it can be effective. For patients with implanted pacemakers, TCM can also reduce the frequency of pacemaker impulses and extend the life of pacemaker batteries. Therefore, further research is needed to identify specific TCM compound preparations tailored to patient needs. Summary of the Invention

[0005] In view of the above-mentioned prior art, the present invention provides a traditional Chinese medicine preparation for treating bradyarrhythmia.

[0006] The present invention is achieved through the following technical solutions:

[0007] A traditional Chinese medicine preparation for treating bradyarrhythmia is prepared from the following raw materials: 10-20 g of ephedra, 25-35 g of black aconite root, 10-20 g of asarum, 25-35 g of processed Chuanwu, 25-35 g of cinnamon twig, 8-12 g of roasted liquorice root, 25-35 g of raw white atractylodes, 25-35 g of raw astragalus, 25-35 g of dried ginger, 10-20 g of cinnamon bark, 15-25 g of pinellia, 8-12 g of ginseng, and 25-35 g of antler frost.

[0008] Preferably, it is prepared from the following raw materials: ephedra 15 g, black aconite root 30 g, asarum 15 g, processed Chuanwu 30 g, cinnamon twig 30 g, roasted liquorice 10 g, raw white atractylodes 30 g, raw astragalus 30 g, dried ginger 30 g, cinnamon bark 15 g, pinellia 20 g, ginseng 10 g, antler frost 30 g.

[0009] The preparation method of the traditional Chinese medicine preparation for treating bradyarrhythmia comprises the following steps:

[0010] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 20-40 minutes, and set aside; mix the ephedra, asarum, cinnamon twig, roasted licorice, raw Atractylodes macrocephala, raw Astragalus, dried ginger, cinnamon bark, Pinellia tuber, ginseng, and antler powder, soak them in water for 20-40 minutes, and set aside;

[0011] (2) Decoction of processed Chuanwu and Heifu Pian for 1-2 hours (decoction first to reduce toxicity; Chuanwu converts aconitine into aconitine during the decoction process. Modern Chinese medicine pharmacology research shows that the toxicity of aconitine is one-five thousandth of that of aconitine. Do not add cold water during the decoction. If the water is low during the decoction, add boiling water);

[0012] (3) Add ephedra, asarum, cinnamon twig, roasted liquorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia tuber, ginseng and antler frost, and boil for 30 to 50 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 30 to 50 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0013] Furthermore, in step (1), the soaking time is 30 minutes.

[0014] Furthermore, in the step (2), when the total weight of the processed Chuanwu and Heifu Pian is 30-50 g, the mixture is decocted for 1 hour; when the total weight exceeds 50 g, the mixture is decocted for 2 hours.

[0015] Furthermore, in step (3), the decocting time is 40 minutes.

[0016] The Chinese medicinal preparation for treating bradyarrhythmia of the present invention has the following therapeutic concept: the disease is a kind of symptom that causes palpitations and anxiety or even inability to control the heart due to deficiency of qi, blood, yin and yang in the heart, or stagnation of phlegm, fluid and blood stasis. Clinically, it is often paroxysmal, often induced by emotional fluctuations or excessive fatigue, accompanied by symptoms such as chest tightness, shortness of breath, insomnia, forgetfulness, and dizziness. The pathogenesis of this disease is deficiency of qi, blood, yin and yang, failure of the heart to nourish, or disturbance of the mind by evil spirits, causing restlessness. The disease is located in the heart and is related to the liver, spleen, kidney and lung. The deficiency of qi, blood, yin and yang is due to deficiency of qi, blood, yin and yang, while the excess of the disease is mostly caused by phlegm and fire disturbing the heart, fluid and fluid rising, or stagnation of blood in the heart, resulting in poor circulation of qi and blood. Based on the etiology and pathogenesis, a Yang-boosting and regulating prescription was developed. The prescription adopts the principle of Zhang Zhongjing's famous prescription Ma Huang Fu Zi Xi Xin Tang. Ma Huang and Fu Zi can warm the kidney and support Yang, while Xi Xin can regulate kidney Yang, thereby assisting Fu Zi's warming Yang effect. Cinnamon bark replenishes fire and supports Yang, raw Astragalus invigorates Qi and supports Yang, and combined with cassia twig, it warms and dredges the meridians. Ginseng is strong in replenishing deficiency, taking into account Yin and fluid without any adverse effects. Raw Atractylodes macrocephala is used to dry dampness and strengthen the spleen, and its raw use is taken for its strong effect. Dried ginger is pungent and dispersing, and is good at warming the middle and restoring Yang, and can relieve the coldness of water and drink. Roasted licorice is used to correct its dryness, nourish Yin and blood, and replenish the heart and spleen qi blood. The present invention selects deer antler frost as a special medicine. Deer antler frost is a product with both blood and flesh. Compared with deer antler glue, it is simple in preparation and economical in price. It has sufficient effect of warming the kidney and restoring Yang, and is more effective when combined with cinnamon bark and cassia twig. The present invention selects processed Chuanwu (rather than other raw materials with similar effects, such as Morinda officinalis and Epimedium, etc.) because Chuanwu is mobile and non-stationary in nature, has a great power of opening and breaking, and can regulate the qi of the internal organs and meridians. When combined with Pinellia ternata, it can unblock the three burners. Once the three burners are unblocked, all diseases will disappear.

[0017] Modern pharmacological research further confirms that the ephedrine component in ephedra, due to its chemical structure being similar to adrenaline, has an adrenaline-mimetic effect, stimulating adrenergic nerves and increasing heart rate. The squalene component in ephedra has lipid-lowering and antioxidant properties, delaying the progression of coronary atherosclerosis caused by hyperlipidemia and peroxidation, promoting blood supply to the sinus node, and protecting its pacemaker function. Aconite root improves atrioventricular conduction, increasing heart rate and exhibiting a significant anti-bradyarrhythmic effect. The volatile oils in asarum can alleviate myocardial ischemia and increase myocardial cell tolerance to hypoxia. Asarum also possesses potent antioxidant properties, alleviating myocardial cell damage caused by oxidative stress and protecting sinus node function. Astragalus root can enhance cardiac contractility and output, thus exerting a cardiotonic effect. Astragalus polysaccharide, an active ingredient in astragalus root, has been shown to effectively combat arrhythmias in experimental rats. Cinnamon twig primarily enhances cardiac output by increasing coronary blood flow. Roasted licorice contains flavonoid alkaloids, polysaccharides and other ingredients, and has a good anti-arrhythmic effect.

[0018] The Chinese medicinal preparation for treating bradyarrhythmia of the present invention is taken orally during treatment (the drug exerts its therapeutic effect through absorption through the gastrointestinal mucosa), one dose per day (the dosage of each raw material drug recorded above is the amount of one dose), taken in two doses, half an hour after breakfast and dinner, and one course of treatment is four weeks of continuous administration.

[0019] The traditional Chinese medicine preparation of the present invention for treating bradyarrhythmias can significantly improve patients' clinical symptoms, including palpitations and anxiety, and restore electrocardiograms to normal or significantly improve, fully demonstrating the advantages of traditional Chinese medicine in treating bradyarrhythmias. Clinical trials showed that after treatment, patients experienced statistically significant improvements in palpitations, anxiety, and chest tightness compared to a Western medicine control group (oral enteric-coated aspirin tablets and isosorbide mononitrate sustained-release tablets) (P < 0.05). Improvements in Holter monitoring and TCM syndrome efficacy were also statistically significant compared to the control group (P < 0.05). The traditional Chinese medicine preparation of the present invention for treating bradyarrhythmias is highly effective, safe, inexpensive, and simple, and has high clinical application value.

[0020] Various terms and phrases used herein have the general meanings that are well known to those skilled in the art. DETAILED DESCRIPTION

[0021] The present invention will be further described below in conjunction with the embodiments. However, the scope of the present invention is not limited to the following embodiments. Those skilled in the art will appreciate that various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention.

[0022] Unless otherwise specified, the instruments, reagents, and materials used in the following examples are all conventional instruments, reagents, and materials available in the prior art and can be obtained through regular commercial channels. The experimental methods and detection methods used in the following examples are all conventional experimental methods and detection methods available in the prior art, unless otherwise specified.

[0023] Example 1 Preparation of a Traditional Chinese Medicine Preparation for Treating Bradyarrhythmia

[0024] The formula is: Ephedra 15 g, Black Aconite 30 g, Asarum 15 g, Processed Chuanwu 30 g, Cinnamon Twig 30 g, Roasted Licorice 10 g, Raw Atractylodes 30 g, Raw Astragalus 30 g, Dried Ginger 30 g, Cinnamon Bark 15 g, Pinellia 20 g, Ginseng 10 g, and Deer Antler Powder 30 g. Each raw material is selected from the corresponding Chinese herbal medicine pieces.

[0025] The preparation method is as follows:

[0026] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 30 minutes, and set aside; mix the ephedra, asarum, cinnamon twig, roasted licorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia, ginseng, and antler powder, soak them in water for 30 minutes, and set aside;

[0027] (2) Boil the processed Chuanwu and Heifupi root for 2 hours;

[0028] (3) Add ephedra, asarum, cinnamon twig, roasted liquorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia tuber, ginseng and antler frost, and boil for 40 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 40 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0029] Clinical research data

[0030] Preliminary research by the research group of the inventor of the present invention has shown that this prescription can significantly improve the patient's clinical symptoms, significantly improve the patient's palpitations and anxiety symptoms, and restore the electrocardiogram to normal or significantly improve, fully demonstrating the advantages of traditional Chinese medicine in treating bradyarrhythmias. At the same time, the inventor of the preparation method has summarized many years of clinical experience, which provides safe and effective guarantees for its clinical promotion and application.

[0031] 1. Clinical data

[0032] 1.1 Diagnostic criteria

[0033] 1.1.1 Western medicine diagnostic criteria

[0034] The Western medicine diagnosis of this study was based on the diagnostic criteria for bradyarrhythmias in Practical Internal Medicine and Practical Cardiology as follows:

[0035] ①Clinical manifestations include palpitations, chest tightness, precordial discomfort, dizziness, fatigue, memory loss, and even syncope and Aspergillus syndrome;

[0036] ② Heart auscultation indicates a heart rate lower than 55 beats / min;

[0037] ③ If the electrocardiogram shows a heart rate of ≤55 beats / min and lasts for ≥1 minute, or the 24-hour dynamic electrocardiogram shows an average heart rate of ≤55 beats / min, sinus bradycardia, various types of heart block, sick sinus syndrome, etc. may occur.

[0038] 1.1.2 Traditional Chinese Medicine Diagnosis and Quantification Standards

[0039] All patients met the TCM diagnosis of Yang deficiency and blood stasis according to the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine." The primary symptoms were palpitations, chest tightness, shortness of breath, and stabbing chest pain. Secondary symptoms included dizziness, loss of voice, chills, cold extremities, fatigue, clear and long urination, loose stools, a dark tongue with visible petechiae or ecchymosis, an overweight body, a thin white or greasy fur, and a deep, sluggish pulse. With two primary symptoms and three of the secondary symptoms, a diagnosis was confirmed.

[0040] 1.2 Inclusion criteria

[0041] (1) Meet the above diagnostic criteria;

[0042] (2) Age 18 to 80 years old;

[0043] (3) The patient has not used drugs that affect cardiac rhythm, or has stopped using them several months ago, and can promise not to take other related drugs voluntarily during treatment;

[0044] (4) those who can be followed up;

[0045] (5) Volunteers who participate in this study.

[0046] 1.3 Exclusion criteria

[0047] (1) Those with allergic constitution or allergic to this drug;

[0048] (2) Patients with liver and kidney dysfunction;

[0049] (3) Patients with a history of severe neurological or mental illness.

[0050] 1.4 Suspension and Exit Criteria

[0051] (1) Those who did not take the drugs as required during the experiment;

[0052] (2) Patients experience severe adverse reactions or changes in their condition;

[0053] (3) Those who voluntarily requested to withdraw from the experiment;

[0054] (4) Those who take related drugs on their own during treatment. Those who are prone to allergies or are allergic to this drug.

[0055] 1.5 Elimination criteria

[0056] (1) Those who are found to not meet the inclusion criteria or meet the exclusion criteria after inclusion;

[0057] (2) Those who were found to have poor compliance and could not strictly follow the treatment plan after inclusion;

[0058] (3) Patients who arbitrarily use prohibited drugs during treatment after inclusion.

[0059] 1.6 Shedding Standard

[0060] (1) Poor compliance or combined use of drugs outside the prescribed range affects the efficacy and safety judgment;

[0061] (2) Those who have allergic reactions or serious adverse events and are not suitable to continue treatment;

[0062] (3) Those who cannot continue the clinical trial due to various reasons, withdraw from the trial or terminate the trial.

[0063] 1.7 General Information

[0064] Eighty patients aged 18 to 80 years diagnosed with bradyarrhythmias who visited the outpatient clinic between January 2019 and January 2022 were enrolled. The patients were randomly divided into a traditional Chinese medicine (TCM) treatment group and a Western medicine (WM) control group. The WM control group received conventional Western medicine treatment (enteric-coated aspirin tablets and sustained-release isosorbide mononitrate tablets). The TCM treatment group received oral Fuyang Tiaolü prescription (i.e., the TCM preparation of the present invention, prepared in Example 1) in addition to the WM placebo. There were no significant differences in age between the groups, and baseline consistency was observed (P>0.05).

[0065] 2. Methods

[0066] 2.1 Treatment methods

[0067] The Western medication control group received enteric-coated aspirin tablets (manufactured by Bayer AG, Germany, batch number 20161025, 0.1 g per tablet) orally once daily, and sustained-release isosorbide mononitrate tablets (manufactured by Lunan Pharmaceutical Group Co., Ltd., batch number 20161218, 40 mg per tablet) orally once daily for 4 consecutive weeks.

[0068] The Chinese medicine treatment group received the Chinese medicine preparation prepared in Example 1 in addition to the placebos of enteric-coated aspirin tablets and isosorbide mononitrate sustained-release tablets (Note: the packaging, shape, and color of both placebos were identical to those of the active drug). The patients received one dose daily, half an hour after breakfast and dinner, for four consecutive weeks.

[0069] 2.2 Observation indicators

[0070] 2.2.1 General Data Observation

[0071] Observe and record the patient's age, disease progression, disease changes during treatment, and any adverse drug reactions during treatment.

[0072] 2.2.2 Evaluation of treatment effect (record once before and after treatment)

[0073] The degree of improvement of dynamic electrocardiogram and traditional Chinese medicine syndrome score.

[0074] Safety evaluation

[0075] Patients should monitor their blood pressure, heart rate and other vital signs during treatment. Blood, urine, stool, and liver and kidney function tests should be performed promptly before and after treatment.

[0076] 2.3 Criteria for determining efficacy

[0077] 2.3.1 Holter electrocardiogram efficacy evaluation criteria

[0078] Holter monitoring efficacy criteria: Markedly effective: average heart rate returns to above 60 beats / min. Effective: average heart rate increases by 20% or more compared to pre-treatment. Ineffective: average heart rate remains unchanged. Aggravated: average heart rate decreases by 20% or more compared to pre-treatment.

[0079] 2.3.2 TCM efficacy standards

[0080] Markedly effective: Clinical symptoms and signs significantly improved, with a ≥70% reduction in TCM syndrome score. Effective: Clinical symptoms and signs improved, with a 30% to <70% reduction in TCM syndrome score. Ineffective: Clinical symptoms and signs did not improve significantly, or even worsened, with a <30% reduction in TCM syndrome score. Worsened: Clinical symptoms and signs worsened, with a <0% reduction in TCM syndrome score.

[0081] 2.3.3 Safety evaluation standards

[0082] Grade 1: Safe, no adverse reactions. Grade 2: Relatively safe, no impact on continued administration, and no special treatment required. Grade 3: Safety issues exist, moderate adverse reactions occur, and administration can continue after treatment. Grade 4: Severe adverse reactions occur, and the trial is terminated.

[0083] 2.3.4 Criteria for judging the severity of adverse events

[0084] Mild: Tolerable, does not affect treatment and recovery, and does not require special treatment. Moderate: Unbearable, requires immediate discontinuation of medication or special treatment, and affects recovery. Severe: Life-threatening, requires immediate discontinuation of medication or emergency treatment.

[0085] 2.4 Medical Ethics Control

[0086] When patients are enrolled in a clinical study, researchers will provide detailed information to the patient or their family regarding the patient's diagnosis using both Traditional Chinese Medicine (TCM) and Western Medicine, TCM syndrome differentiation, treatment options, anticipated treatment goals, and potential adverse reactions. The patient's address and phone number will be recorded for clinical follow-up. If symptoms worsen or discomfort develops after treatment, the patient should contact the researcher promptly to discontinue treatment, address the symptoms, and withdraw from the study. Participation and withdrawal are voluntary throughout the study.

[0087] 2.5 Statistical methods

[0088] All data were statistically analyzed using SPSS 26.0 software. Two-sided tests were generally used for statistical tests, and differences were considered statistically significant when P < 0.05. 2 Frequency, percentage, or composition ratio were used for descriptive analysis. Intergroup comparisons of ranked data were performed using Ridit analysis. The test level was α = 0.05. Measurement data were first analyzed for normality using the KS test. Measurement data that were normally distributed or approximately normally distributed were expressed as mean ± standard deviation (X(-) ± S). Measurement data that did not conform to a normal distribution were expressed as median (interquartile range), or M(Q1, Q3). Data that were normal and had homogeneous variance were analyzed using the t-test; otherwise, the rank sum test was used.

[0089] 3. Results

[0090] 3.1 Comparison of the efficacy of Holter monitoring between the two groups

[0091] The comparison between the two groups was statistically significant after Ridit analysis, u=2.39, P<0.05, as shown in Table 1.

[0092] Table 1 Comparison of the therapeutic effects of Holter monitoring between the two groups

[0093]

[0094] Note: * The comparison between the two groups after treatment was P < 0.05.

[0095] 3.2 Comparison of TCM syndrome efficacy before and after treatment

[0096] After treatment, the two groups showed that the improvement in the Chinese medicine treatment group was significantly better than that in the Western medicine control group (P < 0.05), and the difference was statistically significant, as shown in Table 2.

[0097] Table 2 Comparison of TCM symptom efficacy between the two groups

[0098]

[0099] 3.3 Occurrence of adverse reactions

[0100] The liver and kidney functions of patients in each group were normal before and after treatment, and no adverse reactions occurred in each group.

[0101] 4. Discussion

[0102] Bradyarrhythmias, as defined in Traditional Chinese Medicine (TCM), fall under the categories of "palpitations," "fright," and "palpitations." Traditional Chinese medicine (TCM) offers advantages and safety in treating bradyarrhythmias, and therefore can be used as a foundation for this treatment. The onset of this condition is often associated with deficiency of Qi, blood, Yin and Yang in the heart, or with phlegm, fluid, and blood stasis. The pathogenesis of this condition lies in deficiency of Qi, blood, Yin and Yang, leading to a lack of nourishment for the heart, or the disturbance of the mind by pathogenic factors, resulting in restlessness. The disease is located in the heart and is associated with the liver, spleen, kidneys, and lungs. Deficiency is associated with deficiency of Qi, blood, Yin and Yang, while excess is often caused by phlegm and fire disturbing the heart, the rise of fluid, or blood stasis in the heart, leading to poor flow of Qi and blood. Based on the etiology and pathogenesis of this disease, a formula for supporting yang and regulating qi was developed. This formula draws on the principles of Zhang Zhongjing's famous formula, Ma Huang Fu Zi Xi Xin Tang. Ma Huang and Fu Zi warm the kidneys and support yang, while Xi Xin regulates kidney yang, thus complementing Fu Zi's warming and yang-strengthening effects. Deer Antler Frost warms the kidneys and restores yang, while Cinnamon Bark replenishes fire and supports yang. Raw Astragalus Invigorates Qi and supports yang, and combined with Cassia Twig warms and unblocks the meridians. Ginseng has a strong tonic effect, while also supporting yin and fluid without any side effects. Raw Atractylodes Macrocephala is known for its strong effect in drying dampness and strengthening the spleen. Dried ginger is pungent and dispersing, excelling at warming the middle and restoring yang, and can dispel the effects of water retention. Roasted Licorice is used to counteract its dryness, nourishing yin and blood, and tonifying the heart and spleen qi and blood. Chuan Wu, with its mobile, non-static nature, has a powerful opening and breaking power, regulating the qi of the internal organs and meridians. Pinellia Tuber is known to unblock the three burners, and once unblocked, all ailments will resolve.

[0103] Clinical research results show that the Fuyang Tiaolu formula helps improve symptoms such as palpitations and anxiety in patients with bradyarrhythmias, with statistically significant improvements compared to conventional Western medication (P < 0.05). This may be because, compared to single antiarrhythmic treatments, the Fuyang Tiaolu formula improves the clinical symptoms of bradyarrhythmias in multiple ways and at multiple levels, enhancing the therapeutic effect to a certain extent.

[0104] 5. Conclusion

[0105] The clinical application effect of the Fuyang Tiaolü prescription of the present invention is significantly better than the clinically commonly used isosorbide mononitrate sustained-release tablets, and has good safety, which provides a guarantee for its clinical promotion.

[0106] Example 2 Preparation of a Traditional Chinese Medicine Preparation for Treating Bradyarrhythmia

[0107] The formula is: Ephedra 10 g, Black Aconite 35 g, Asarum 10 g, Processed Chuanwu 35 g, Cinnamon Twig 25 g, Roasted Licorice 12 g, Raw Atractylodes 25 g, Raw Astragalus 35 g, Dried Ginger 25 g, Cinnamon Bark 20 g, Pinellia 15 g, Ginseng 12 g, and Deer Antler Powder 25 g. Each raw material is selected from the corresponding Chinese herbal medicine pieces.

[0108] The preparation method is as follows:

[0109] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 30 minutes, and set aside; mix the ephedra, asarum, cinnamon twig, roasted licorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia, ginseng, and antler powder, soak them in water for 30 minutes, and set aside;

[0110] (2) Boil the processed Chuanwu and Heifupi root for 2 hours;

[0111] (3) Add ephedra, asarum, cinnamon twig, roasted liquorice, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia tuber, ginseng and antler frost, and boil for 50 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 50 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0112] Example 3 Preparation of a Traditional Chinese Medicine Preparation for Treating Bradyarrhythmia

[0113] The formula is: Ephedra 20 g, Black Aconite 25 g, Asarum 20 g, Processed Chuanwu 25 g, Cinnamon Twig 35 g, Roasted Licorice 8 g, Raw Atractylodes 35 g, Raw Astragalus 25 g, Dried Ginger 35 g, Cinnamon Bark 10 g, Pinellia 25 g, Ginseng 8 g, and Deer Antler Powder 35 g. Each raw material is selected from the corresponding Chinese herbal medicine pieces.

[0114] The preparation method is as follows:

[0115] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 30 minutes, and set aside; mix the ephedra, asarum, cinnamon twig, roasted licorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia, ginseng, and antler powder, soak them in water for 30 minutes, and set aside;

[0116] (2) Boil the processed Chuanwu and Heifupi root for 1 hour;

[0117] (3) Add ephedra, asarum, cinnamon twig, roasted liquorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia tuber, ginseng and antler frost, and boil for 30 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 30 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0118] Example 4 Preparation of a Traditional Chinese Medicine Preparation for Treating Bradyarrhythmia

[0119] The prescription is as follows: Ephedra 13 g, Black Aconite 33 g, Asarum 13 g, Processed Chuanwu 33 g, Cinnamon Twig 28 g, Roasted Licorice 11 g, Raw Atractylodes 28 g, Raw Astragalus 33 g, Dried Ginger 28 g, Cinnamon Bark 13 g, Pinellia 22 g, Ginseng 9 g, and Deer Antler Powder 28 g.

[0120] The following steps are involved:

[0121] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 40 minutes, and set aside; mix the ephedra, asarum, cinnamon twig, roasted licorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia, ginseng, and antler powder, soak them in water for 40 minutes, and set aside;

[0122] (2) Boil the processed Chuanwu and Heifupi root for 2 hours;

[0123] (3) Add ephedra, asarum, cinnamon twig, roasted liquorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia tuber, ginseng and antler frost, and boil for 40 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 40 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0124] Example 5 Preparation of a Traditional Chinese Medicine Preparation for Treating Bradyarrhythmia

[0125] The prescription is: Ephedra 18 g, Black Aconite 28 g, Asarum 18 g, Processed Chuanwu 28 g, Cinnamon Twig 32 g, Roasted Licorice 9 g, Raw Atractylodes 32 g, Raw Astragalus 28 g, Dried Ginger 32 g, Cinnamon Bark 18 g, Pinellia 18 g, Ginseng 11 g, and Deer Antler Frost 32 g.

[0126] The following steps are involved:

[0127] (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 20 minutes, and set aside; mix the ephedra, asarum, cinnamon twig, roasted licorice, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia, ginseng, and antler powder, soak them in water for 20 minutes, and set aside;

[0128] (2) Boil the processed Chuanwu and Heifupi root for 2 hours;

[0129] (3) Add ephedra, asarum, cinnamon twig, roasted liquorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia tuber, ginseng and antler frost, and boil for 40 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 40 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

[0130] The above examples are provided to those skilled in the art to fully disclose and describe how to implement and use the claimed embodiments, rather than to limit the scope of the disclosure herein. Modifications that are obvious to those skilled in the art will fall within the scope of the appended claims.

Claims

1. A Chinese medicine preparation for treating bradyarrhythmia, characterized in that: It is made from the following raw materials: ephedra 10-20 g, black aconite root 25-35 g, asarum 10-20 g, processed Chuanwu 25-35 g, cinnamon twig 25-35 g, roasted liquorice root 8-12 g, raw white atractylodes 25-35 g, raw astragalus 25-35 g, dried ginger 25-35 g, cinnamon bark 10-20 g, pinellia 15-25 g, ginseng 8-12 g, and antler frost 25-35 g.

2. The Chinese medicine preparation for treating bradyarrhythmia according to claim 1, characterized in that It is made from the following raw materials: ephedra 15 g, black aconite root 30 g, asarum 15 g, processed Chuanwu 30 g, cinnamon twig 30 g, roasted liquorice 10 g, raw white atractylodes 30 g, raw astragalus 30 g, dried ginger 30 g, cinnamon bark 15 g, pinellia 20 g, ginseng 10 g, and antler powder 30 g.

3. The Chinese medicine preparation for treating bradyarrhythmia according to claim 1, characterized in that It is made from the following raw materials: ephedra 10 g, black aconite root 35 g, asarum 10 g, processed Chuanwu 35 g, cinnamon twig 25 g, roasted liquorice root 12 g, raw white atractylodes 25 g, raw astragalus 35 g, dried ginger 25 g, cinnamon bark 20 g, pinellia 15 g, ginseng 12 g, and antler powder 25 g.

4. The Chinese medicinal preparation for treating bradyarrhythmia according to claim 1, characterized in that It is made from the following raw materials: Ephedra 20 g, Black Aconite 25 g, Asarum 20 g, Processed Chuanwu 25 g, Cinnamon Twig 35 g, Roasted Licorice 8 g, Raw Atractylodes 35 g, Raw Astragalus 25 g, Dried Ginger 35 g, Cinnamon Bark 10 g, Pinellia 25 g, Ginseng 8 g, and Deer Antler Powder 35 g.

5. The Chinese medicinal preparation for treating bradyarrhythmia according to claim 1, characterized in that It is made from the following raw materials: ephedra 13 g, black aconite root 33 g, asarum 13 g, processed Chuanwu 33 g, cinnamon twig 28 g, roasted liquorice root 11 g, raw white atractylodes 28 g, raw astragalus 33 g, dried ginger 28 g, cinnamon bark 13 g, pinellia 22 g, ginseng 9 g, and antler powder 28 g.

6. The Chinese medicinal preparation for treating bradyarrhythmia according to claim 1, characterized in that It is made from the following raw materials: ephedra 18 g, black aconite root 28 g, asarum 18 g, processed Chuanwu 28 g, cinnamon twig 32 g, roasted liquorice 9 g, raw white atractylodes 32 g, raw astragalus 28 g, dried ginger 32 g, cinnamon bark 18 g, pinellia 18 g, ginseng 11 g, and antler powder 32 g.

7. The method for preparing the traditional Chinese medicine preparation for treating bradyarrhythmia according to any one of claims 1 to 6, characterized in that: The following steps are involved: (1) Mix the processed Chuanwu and Heifu Pian, soak them in water for 20-40 minutes, and set aside; mix the ephedra, asarum, cinnamon twig, roasted licorice, raw Atractylodes macrocephala, raw Astragalus, dried ginger, cinnamon bark, Pinellia tuber, ginseng, and antler powder, soak them in water for 20-40 minutes, and set aside; (2) Boil the processed Chuanwu and Heifupi root for 1 to 2 hours; (3) Add ephedra, asarum, cinnamon twig, roasted liquorice root, raw white atractylodes, raw astragalus, dried ginger, cinnamon bark, pinellia tuber, ginseng and antler frost, and boil for 30 to 50 minutes. Pour out the medicine soup, which is the first decoction; add water to the residue and boil for another 30 to 50 minutes. Pour out the medicine soup, which is the second decoction; mix the two decoctions together.

8. The preparation method according to claim 7, characterized in that: In the step (1), the soaking time is 30 minutes.

9. The preparation method according to claim 7, characterized in that: In the step (2), when the total weight of the processed Chuanwu and Heifu Pian is 30-50 g, the mixture is decocted for 1 hour; when the total weight exceeds 50 g, the mixture is decocted for 2 hours.

10. The preparation method according to claim 7, characterized in that: In the step (3), the decocting time is 40 minutes.

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