Traditional Chinese medicine composition for treating bradyarrhythmia as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating bradyarrhythmia and a preparation method and application thereof.The composition is prepared from, by weight, 20-45 parts of astragalus membranaceus, 3-12 parts of ephedra, 3-10 parts of cinnamon, 3-12 parts of American ginseng, 3-12 parts of asarum, 1-6 parts of pseudo-ginseng, 3-10 parts of rhodiola rosea, 3-12 parts of radix bupleuri, 3-12 parts of rhizoma cimicifugae and 1-10 parts of galangal. The traditional Chinese medicine composition is mainly used for treating various chronic arrhythmia patients with heart, spleen and kidney yang deficiency, middle-jiao qi deficiency, blood coagulation due to cold and collateral obstruction due to blood stasis, and can be used for obviously treating chronic arrhythmia. Clinical research shows that the efficacy of the traditional Chinese medicine composition is superior to that of Xinbao pills.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating bradyarrhythmia, a preparation method and application thereof. Background Art

[0002] Bradyarrhythmia refers to a ventricular rate of <60 beats / min, including sinus bradycardia, sinoatrial block, atrioventricular block, various escape rhythms, and sick sinus syndrome. It is currently believed that the pathogenesis of bradyarrhythmia is mainly related to degenerative changes in the conduction system, autonomic dysfunction, abnormal myocardial ion channel genes, and the absence of certain structural proteins. With age, the aging of the sinus node and atrioventricular node increases, and the calcification of the atrioventricular valve leads to distortion of the conduction system, making the elderly more susceptible to sick sinus syndrome and atrioventricular block.

[0003] Bradycardia often causes dizziness, palpitations, fatigue, etc. In severe cases, it can cause critical conditions such as blackouts and fainting, and even endanger the patient's life.

[0004] Western medicine treatment can increase the patient's heart rate in a short period of time, but the effect is short-lived and has many side effects, making it generally difficult to take for a long time.

[0005] Surgical treatment mainly involves installing a pacemaker, but it often faces problems such as infection, bleeding, lead displacement, and pacemaker syndrome after surgery. In addition, surgical treatment is expensive, has strict surgical indications and contraindications, and faces problems such as postoperative complications, so its clinical promotion is subject to certain limitations.

[0006] Therefore, it is urgent to find new and effective prescriptions and medicines in the field of traditional Chinese medicine, give full play to the clinical advantages of traditional Chinese medicine in preventive treatment, and provide patients with alternative clinical options. Summary of the invention

[0007] In view of the deficiencies in the prior art, the present invention provides a Chinese medicine composition for treating bradyarrhythmia, a preparation method and application thereof.

[0008] In order to achieve the purpose of the present invention, the technical solution adopted is as follows:

[0009] A traditional Chinese medicine composition for treating bradyarrhythmia, wherein the raw materials of the traditional Chinese medicine composition are, by weight, 20-40 parts of astragalus, 1-10 parts of ephedra, 1-10 parts of cinnamon, 1-10 parts of American ginseng, 1-5 parts of asarum, 1-5 parts of notoginseng, 1-10 parts of rhodiola, 1-10 parts of bupleurum, 1-10 parts of cimicifuga and 1-10 parts of galangal.

[0010] Bradyarrhythmia belongs to the category of "slow pulse", "palpitations" and "vertigo" in traditional Chinese medicine. Its pathogenesis is a syndrome of deficiency of the root and excess of the superficial. The root is the deficiency of the heart, spleen and kidney yang qi, and the superficial excess is mainly cold stagnation, phlegm and blood stasis, and the two can transform into each other. The disease is aggravated by the mixture of deficiency and excess. The disease is located in the heart, involving the spleen and kidney. The treatment is to warm and tonify the heart and kidney, invigorate qi and raise yang, dispel cold and dredge the meridians. The inventor developed this Chinese medicine composition based on his more than 30 years of clinical experience in treating cardiovascular diseases. The preliminary clinical study observed 240 patients with bradycardia for 5 years. The results showed that the composition of the present invention can significantly increase the heart rate of patients with bradycardia, with good safety and no adverse reactions.

[0011] Preferably, the raw materials of the traditional Chinese medicine composition are 25-35 parts of astragalus, 3-9 parts of ephedra, 2-8 parts of cinnamon, 3-9 parts of American ginseng, 3-9 parts of asarum, 2-4 parts of Panax notoginseng, 3-9 parts of rhodiola, 3-9 parts of bupleurum, 3-9 parts of cimicifuga and 1-5 parts of galangal.

[0012] Preferably, the raw materials of the traditional Chinese medicine composition are 25-35 parts of astragalus, 3-9 parts of ephedra, 3-8 parts of cinnamon, 3-9 parts of American ginseng, 3-9 parts of asarum, 2-4 parts of Panax notoginseng, 3-9 parts of rhodiola, 3-9 parts of bupleurum, 3-9 parts of cimicifuga and 1-5 parts of galangal.

[0013] Preferably, the raw materials of the traditional Chinese medicine composition are 30 parts of astragalus, 6 parts of ephedra, 5 parts of cinnamon, 6 parts of American ginseng, 6 parts of asarum, 3 parts of Panax notoginseng, 6 parts of rhodiola, 6 parts of bupleurum, 6 parts of cimicifuga and 3 parts of galangal.

[0014] The second object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0015] (1) extracting the Chinese medicinal materials except Panax notoginseng with water to obtain an extract;

[0016] (2) preparing Panax notoginseng powder;

[0017] (3) Mix the extract and Panax notoginseng powder to obtain the product.

[0018] Preferably, the extraction in step (1) is performed by decoction, the number of decoctions is 1-3 times, the time of each decoction is 0.5-1.5 hours, and the amount of water added is 6-12 times the sum of the mass of the Chinese medicinal materials except Panax notoginseng.

[0019] Another object of the present invention is to provide a pharmaceutical preparation comprising the above-mentioned Chinese medicine composition and pharmaceutically acceptable excipients.

[0020] Preferably, the preparation is in the form of granules, capsules, powders or tablets.

[0021] Preferably, the dosage form of the preparation is granules, the granules are prepared by wet granulation, and the binder is ethanol with a volume concentration of 85-95%.

[0022] Preferably, the wet granulation method comprises adding extracts of Chinese medicinal materials other than Panax notoginseng and Panax notoginseng powder into a wet granulator for mixing; adding the binder into the wet granulator to prepare a soft material; granulating through a 14-mesh sieve, and drying to obtain the product.

[0023] Further preferably, the preparation method of the above-mentioned Chinese medicine composition into granules is as follows:

[0024] (1) The medicinal materials except Panax notoginseng powder were decocted with water twice, with 10 times the amount of water added for the first time and 8 times the amount of water added for the second time. Each decoction was decocted for 1 hour. The extracts were combined and concentrated. The concentrate was dried under microwave vacuum at 60°C and crushed to pass through a 60-mesh sieve to obtain a dry paste powder extract.

[0025] (2) Mixing: Add the prescribed amount of extract, Panax notoginseng powder, crushed sucrose, dextrin, and aspartame into a wet granulator and mix for 5 minutes.

[0026] (3) Granulation: Slowly add the binder into the wet granulator while stirring. After complete addition, start high-speed shearing for 30 seconds and stop to discharge.

[0027] (4) Granulation: Add the prepared soft material into a swing granulator and granulate it using a 14-mesh screen.

[0028] (5) Drying: Add the prepared granules to a fluidized bed or positive vacuum drying oven and dry at 60°C until the moisture content is ≤5%.

[0029] (6) Sieving: The dried granules are sieved with a 10-mesh sieve.

[0030] (7) Packaging: The sieved particles are packaged in 15 g / bag, and the packaging volume difference is controlled within ±5%.

[0031] Another object of the present invention is to provide the use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the preparation method in the preparation of arrhythmia or heart failure drugs.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] (1) The Chinese medicine composition of the present invention is mainly used to treat various bradyarrhythmias caused by deficiency of heart, spleen and kidney yang, insufficient qi in the middle, cold stagnation of blood vessels, and blood stasis blocking the collaterals. Symptoms include shortness of breath, laziness to speak, shortness of breath, fatigue, dizziness, or syncope, or waking up at night due to holding back, pale complexion, fear of cold and cold limbs, clear and long urine, dark tongue or ecchymosis, and slow or intermittent pulse.

[0034] (2) This prescription is guided by the theory of traditional Chinese medicine. Raw Astragalus membranaceus nourishes the Qi of the heart and lungs, benefits the acquired constitution, replenishes the damaged five internal organs, harmonizes the essence and nourishes the mind, and calms the soul; Cinnamon bark helps the heart Yang, replenishes the original Yang, dispels cold and relieves adverse reactions; Roasted Ephedra is pungent and sweet, enters the heart meridian, warms the Yang, stimulates the Yang, and nourishes the Wei; the three herbs are combined to warm and nourish the heart, spleen, and kidneys, dispel cold and relieve adverse reactions.

[0035] American ginseng replenishes the middle qi and helps astragalus to replenish qi and raise yang; Panax notoginseng and Rhodiola rosea replenish qi, activate blood circulation and dredge collaterals to relieve the problem of cold stagnation in blood vessels; Asarum warms the heart and kidneys, and is combined with cinnamon and ephedra. Ephedra enters the Taiyang meridian, and cinnamon enters the Shaoyin meridian. Asarum enters the two meridians to connect the inside and outside, relieving the cold on the outside and dispersing the cold inside. It is pungent and warm to generate hair, dispersing dampness and promoting blood circulation. The three medicines are used together to make the Tai and Shao meridians interact with each other through the triple burner and the skin, thereby removing the cold of Shaoyin and reaching the surface of the Taiyang meridian. The above medicines are ministerial medicines.

[0036] Bupleurum and Cimicifuga can raise the yang and lift the sunken, helping the above medicines to raise the clear yang qi. Alpinia officinalis warms the stomach and stops vomiting, dispels cold and relieves pain. The combination of these medicines has the effects of warming and nourishing the heart and kidneys, replenishing qi and raising yang, dispelling cold and unblocking the meridians. DETAILED DESCRIPTION

[0037] The present invention is further described below in conjunction with specific embodiments. The raw materials in the following examples are all commercially available conventional raw materials.

[0038] The raw materials and auxiliary materials used in the present invention should comply with the provisions of the corresponding varieties in the Pharmacopoeia of the People's Republic of China (2010 edition). The following parts are all parts by weight.

[0039] Embodiment 1:

[0040]

[0041] The preparation method is as follows:

[0042] (1) The above medicinal materials except Panax notoginseng powder were decocted with water twice, with 10 times the amount of water added for the first time and 8 times the amount of water added for the second time. Each time, the decocting was for 1 hour. The extracts were combined and concentrated. The concentrate was dried under microwave vacuum at 60°C and crushed to pass through a 60-mesh sieve to obtain a dry paste powder extract.

[0043] (2) Adhesive preparation: The preparation process requires an adhesive with an alcohol content of 90%.

[0044] (3) Mixing: Add the dry powder extract, Panax notoginseng powder, 5 g sucrose, 5 g dextrin, and 0.8 g aspartame into a wet granulator and mix for 5 min.

[0045] (4) Granulation: Slowly add the prepared binder into the wet granulator while stirring. After complete addition, start high-speed shearing for 30 seconds, stop and discharge.

[0046] (5) Granulation: Add the prepared soft material into a swing granulator and granulate it using a 14-mesh screen.

[0047] (6) Drying: Add the prepared granules to a fluidized bed or positive vacuum drying oven and dry at 60°. Dry until the moisture content is ≤5%.

[0048] (7) Sieving: The dried granules are sieved with a 10-mesh sieve.

[0049] (8) Packaging: The sieved particles are packaged in 15 g / bag, and the difference in packaging volume is controlled within ±5%.

[0050] Embodiment 2:

[0051]

[0052] The preparation method is the same as that of Example 1.

[0053] Embodiment 3:

[0054]

[0055] The preparation method is the same as that of Example 1.

[0056] Experiment 1: Clinical Research

[0057] 1.1 Case source

[0058] The cases were obtained from the outpatient department of Traditional Chinese Medicine, Fuwai Hospital, Chinese Academy of Medical Sciences from January 2020 to January 2024. A total of 240 patients who met the diagnostic criteria for bradyarrhythmia and whose TCM syndrome differentiation was heart-kidney yang deficiency and blood stasis blocking the collaterals were selected.

[0059] 1.2 Diagnostic criteria

[0060] 1.2.1 Western medicine diagnostic criteria

[0061] The relevant diagnostic standards of Western medicine are based on "Internal Medicine" and "Standardized Training Course for Cardiology Specialists of Fuwai Hospital", and the relevant electrocardiogram diagnostic standards are based on "Electrocardiography" (written by Huang Wan). Excluding other factors such as drugs and neurosis, the diagnosis can be made if any of the following is met:

[0062] ① The heart rate does not exceed 50 beats per minute;

[0063] ② Second degree sinoatrial block;

[0064] ③ Sinus arrest lasting more than two seconds;

[0065] ④ Second degree atrioventricular block or third degree atrioventricular block;

[0066] ⑤ The dynamic electrocardiogram shows that the total number of heart beats in 24 hours does not exceed 80,000 times, the slowest heart rate does not exceed 40 beats per minute, the fastest heart rate does not exceed 90 beats per minute, and the average heart rate does not exceed 55 beats per minute; with or without SAB, sinus arrest, or sinus bradycardia;

[0067] ⑥ Atropine test: After using atropine, the electrocardiogram shows that the sinus rhythm is still less than ninety beats per minute, or junctional rhythm occurs, or sinoatrial or atrioventricular conduction block, sinus arrest occurs.

[0068] ⑦ Atrial pacing test: the corrected sinoatrial recovery time exceeds 550 milliseconds, the sinoatrial node recovery time exceeds 1,500 milliseconds, the sinoatrial node effective refractory period exceeds 600 milliseconds, and the sinoatrial node conduction time exceeds 120 milliseconds.

[0069] 1.2.2 The diagnostic criteria of traditional Chinese medicine are based on the "Technical Guidelines for Clinical Research on Syndrome-Based New Chinese Medicines". The main symptoms are shortness of breath and fatigue, dizziness or syncope, palpitations, chest pain, and secondary symptoms are fatigue and sluggishness, spontaneous sweating, chills, soreness of waist and knees, pale tongue, enlarged tongue, thin white or white and smooth tongue coating, deep and slow pulse, or weak and astringent pulse, or intermittent pulse, or thin and weak pulse.

[0070] Calculation of TCM symptom score: Based on the patient's main and secondary symptoms, tongue coating, and pulse, refer to the TCM syndrome score scale.

[0071] 1.3 Case selection criteria

[0072] 1.3.1 Case inclusion criteria

[0073] ① The age range is between 18 and 80 years old;

[0074] ② Meet the above-mentioned Western medical diagnostic criteria;

[0075] ③ TCM syndrome differentiation is heart and kidney yang deficiency, insufficient middle qi, and cold blood stasis;

[0076] ④No history of pacemaker implantation;

[0077] ⑤ Those who have not taken other drugs that affect heart rhythm or other related clinical observations within 2 weeks and are willing to accept Chinese medicine treatment;

[0078] ⑥ The individual and his / her family members are fully informed and voluntarily sign the informed consent form.

[0079] 1.3.2 Case Exclusion Criteria

[0080] ① Does not meet the above-mentioned standards of traditional Chinese medicine and Western medicine;

[0081] ② Sinusitis caused by secondary causes such as drugs and autonomic nervous system dysfunction;

[0082] ③ Recurrent cardiogenic shock accompanied by short-term atrial fibrillation, atrial flutter, supraventricular tachycardia and other malignant arrhythmias;

[0083] ④ Patients with critical diseases of the brain, urinary system, nerves, or blood system; patients with other bleeding diseases such as coagulation abnormalities and blood diseases;

[0084] ⑤ Those who refuse Chinese medicine, cannot tolerate the taste of Chinese medicine, or have allergic reactions to Chinese medicine ingredients;

[0085] ⑥ Other drugs that may interfere with the observation results must be taken due to illness;

[0086] ⑦ Have indications for pacemaker implantation or have a history of pacemaker implantation;

[0087] ⑧ Women who are pregnant or breastfeeding, or those who suffer from mental illness or are incapable of acting;

[0088] 2. Research Methods

[0089] 2.1 Randomization method: According to the random number table method, 240 patients who met the inclusion criteria were selected and divided into an observation group and a control group, with 120 cases in each group.

[0090] 2.2 Treatment methods

[0091] The patients' basic western medicine for cardiovascular disease treatment remained unchanged, and the observation group was given the Chinese medicine composition prepared in Example 1, 10 g each time, twice a day. The control group was given Xinbao Pills 240 mg / time, three times a day, with warm water. The course of treatment was 4 weeks.

[0092] 2.3 Observation indicators before and after treatment

[0093] (1) TCM syndrome: TCM syndrome score and TCM syndrome total efficacy.

[0094] (2) 24-hour electrocardiogram: number of long RR intervals, longest RR interval, average heart rate, slowest heart rate, and fastest heart rate.

[0095] (3) Safety monitoring of patients’ liver and kidney function, blood, urine, stool routine tests, and coagulation function before and after treatment.

[0096] 2.4 Evaluation criteria for treatment efficacy

[0097] 2.4.1 TCM syndrome score and evaluation of treatment effect

[0098] Evaluation of the overall efficacy of TCM syndromes:

[0099] Therapeutic index = (score before treatment - score after treatment) / score before treatment × 100%.

[0100] 2.4.2 Statistical analysis was performed on the basic data of the patients, such as gender, age, duration of illness, and underlying cardiovascular diseases. Pearson chi-square test, two independent sample t-test, and corrected χ test were performed on gender, age, whether there was underlying cardiovascular disease, and duration of disease according to different data types. 2 Test and two independent sample t test. It was concluded that the differences between the two groups of patients in terms of gender, age, presence of underlying diseases and other general conditions were not statistically significant and had no significant impact on the observed results.

[0101] 3. Results

[0102] 3.1 The total efficacy of TCM syndromes of the Chinese medicine of the present invention

[0103] The TCM symptoms of the two groups of subjects before and after treatment were statistically analyzed. The comparison of the overall therapeutic effect of TCM symptoms of the two groups of subjects is shown in Table 1.

[0104] Table 1 Comparison of the total efficacy of TCM syndromes in the two groups of patients

[0105] Grouping (Example) Significantly effective (example) Valid (Example) Invalid (Example) Total effective rate (%) Observation group (n=120) 56(46.7％) 55 cases (45.8%) 9 cases (7.5%) 92.5％* Control group (n=120) 9(7.5％) 71 cases (59.2%) 40 cases (33.3%) 63.7％

[0106] Note: *P<0.05 indicates that the observation group was compared with the control group.

[0107] Results: The number and proportion of cases with marked effect, full effect and ineffectiveness in the observation group were 56 (46.7%), 55 (45.8%) and 9 (7.5%) respectively; the number and proportion of cases with marked effect, full effect and ineffectiveness in the control group were 9 (7.5%), 71 (59.2%) and 40 (33.3%) respectively; the total effective rate was 92.5% in the observation group and 66.3% in the control group. The data of the two groups were ordered categorical variable data, so when comparing the efficacy levels between the two, the Wilcoxon rank sum test method was used. In the analysis of the total efficacy data of the two groups of TCM symptom scores, it can be seen that there are significant differences between the observation group and the control group, and the efficacy of the observation group is significantly better than that of the control group.

[0108] 3.2 The efficacy of the Chinese medicine composition of the present invention on TCM syndrome score

[0109] The total score of TCM symptoms of the two groups of patients before and after treatment was statistically analyzed. The results are shown in Table 2. There was no statistically significant difference in the TCM syndrome scores of the two groups of subjects before treatment: P = 0.756 (P > 0.05) (two independent sample t test); the difference before and after treatment in the Example 1 group was statistically significant: P = 0.00 (P < 0.01) (paired t test); the difference in the total score of the control group before and after treatment was statistically significant: P = 0.021 (P < 0.05) (paired t test); the difference in the TCM symptom score between the two groups after treatment was also significantly different, and the Example 1 group was significantly better than the control group, P < 0.01 (P = 0.00) (two independent sample t test).

[0110] Table 2 Comparison of total TCM syndrome scores between the two groups of patients (x±s)

[0111]

[0112] Note: Compared with before treatment *P<0.01, #P<0.05; compared with the control group, ■ P<0.01.

[0113] 3.3 Effect of the composition of the present invention on 24-hour electrocardiogram heart rate changes

[0114] The 24-hour electrocardiogram and heart rate changes of the two groups of patients before and after treatment were analyzed, and the results are shown in Tables 3 and 4.

[0115] Table 3 Comparison of average heart rate of 24-hour electrocardiogram between the two groups of patients (x±s)

[0116]

[0117] Note: Compared with before treatment, #P<0.01, *P>0.05;

[0118] Compared with the control group, ●P<0.01, ■P<0.01.

[0119] The results showed that there was no statistically significant difference in the average heart rate of the electrocardiogram 24 hours before treatment between the observation group and the control group: P>0.05 (P=0.769) (two independent sample t test); there was a significant difference in the average heart rate before and after treatment in the observation group, P=0.00 (P<0.01) (rank sum test); there was no significant difference in the average heart rate before and after treatment in the control group: P=0.083 (P>0.05) (rank sum test). There was a significant difference in the difference in the average heart rate of the electrocardiogram of the two groups of patients 24 hours after treatment: P<0.01 (P=0.000) (rank sum test), which confirmed that the composition of the present invention can significantly increase the average heart rate of patients with bradyarrhythmia, and is superior to the traditional Chinese medicine Xinbao Pills.

[0120] Table 4 Comparison of the slowest heart rate of 24-hour electrocardiogram between the two groups of patients (x±s)

[0121]

[0122] Note: Compared with before treatment, #P<0.01, *P>0.05;

[0123] Compared with the control group, ●P<0.01, ■P<0.01.

[0124] The results showed that there was no significant difference in the slowest heart rate of the electrocardiogram 24 hours before treatment between the observation group and the control group: P>0.05 (P=0.574) (two independent sample t test); there was a significant difference in the slowest heart rate 24 hours before and after treatment in the observation group: P=0.00 (P<0.01) (rank sum test); there was no significant difference in the slowest heart rate 24 hours before and after treatment in the control group (rank sum test), P>0.05 (P=0.088); there was a significant difference in the slowest heart rate 24 hours after treatment between the observation group and the control group, P=0.00 (P<0.01) (rank sum test).

[0125] 3.4 Effect of the Composition of the Invention on the Number and Duration of Long RR Intervals

[0126] The number and duration of long RR intervals greater than 2 seconds in the 24-hour electrocardiogram of the two groups of patients before and after treatment were analyzed, and the results are shown in Table 5.

[0127] The results showed that there was no significant difference in the number and longest time of long RR intervals greater than 2 seconds in the electrocardiogram 24 hours before treatment between the observation group and the control group: P = 0.627 (P > 0.05) (two independent sample t test); there was a significant difference in the number and longest time of long RR intervals greater than 3 seconds in the observation group before and after treatment: P = 0.00 (P < 0.01) (rank sum test); there was no significant difference in the number and longest time of long RR intervals in the control group before and after treatment (P > 0.05) (rank sum test); and the reduction degree of the number and longest time of long RR intervals in the observation group after treatment was better than that in the control group: P = 0.001 (P < 0.01) (rank sum test).

[0128] Table 5 Comparison of the number and longest duration of long RR intervals between the two groups of patients (x±s)

[0129]

[0130]

[0131] Note: Compared with before treatment, #P<0.01, *P>0.05;

[0132] Compared with the control group, ●P<0.01, ■P<0.01.

[0133] 4. Safety observation of the composition of the present invention in treating bradyarrhythmias

[0134] 4.1 Adverse reactions of the composition of the present invention

[0135] During the treatment with the composition of the present invention and Xinbao Pills, some patients experienced dry mouth, but no other adverse reactions were observed.

[0136] 4.2 Effects of the composition of the present invention on urine routine, coagulation function, stool routine and occult blood test

[0137] The urine routine test, coagulation function test, stool routine test and occult blood test of the patients in the observation group and the control group of the composition of the present invention before and after treatment were normal.

[0138] 4.3 Effects of the composition of the present invention on liver and kidney function

[0139] The liver and kidney functions of the patients in the observation group and the control group of the composition of the present invention were normal before and after treatment, and there was no statistical difference.

[0140] 5 Discussions

[0141] Bradyarrhythmia belongs to the categories of "dizziness", "palpitations", "chest pain and heart pain", "syncope", "slow pulse", "intermittent pulse" and so on in traditional Chinese medicine. Wu Qian, a famous doctor in the Qing Dynasty, said, "Dizziness occurs when the head is dizzy and the eyes are dark. Yang damage causes qi to sink, the body shakes, and sometimes you want to fall to the ground, because the yang damage and the strength cannot support it. "Pulse Classic" says: "Slow pulse is a disease of cold entering the Jueyin meridian, and it enters five points." "Medical Ancestor Golden Mirror" says "Slow pulse is mainly in the yin, and the disease is in the viscera." This disease is mostly caused by yang deficiency and cold accumulation, and is treated by warming yang and dispersing cold. Director Ma Lihong is the third-generation descendant of Mr. Shi Jinmo, a famous doctor in Beijing, and the academic inheritor of Ding Mingjiu and Li Jieming, famous doctors in Beijing. On the basis of inheriting Shi's "Ten Principles Dialectics" and "Qi and Blood Theory", combined with Zhongjing's "Treatise on Febrile Diseases", he formulated and prepared the granules of the present invention. Director Ma Lihong believes that the disease is a syndrome of deficiency of the root and excess of the superficial. The root is the deficiency of the heart, spleen and kidney yang qi, and the superficial is cold stagnation and phlegm. The main symptoms are yin and blood stasis, and the two can transform into each other. The disease is aggravated by the mixture of deficiency and excess due to deficiency. The disease is located in the heart, involving the spleen and kidney. The treatment is mainly to warm and nourish the heart and kidney, invigorate qi and raise yang, dispel cold and dredge the collaterals. The granules of the present invention are mainly used to treat various bradyarrhythmias with symptoms of deficiency of heart, spleen and kidney yang, insufficient qi in the middle, cold coagulation of blood vessels, and blood stasis blocking the collaterals. The symptoms include shortness of breath and laziness to speak, shortness of breath and fatigue, dizziness and black fog, or syncope, or waking up at night, pale complexion, fear of cold and cold limbs, clear and long urine, dark tongue or ecchymosis, and slow or intermittent pulse. In the prescription Raw Astragalus can replenish the Qi of the heart and lungs, benefit the acquired foundation, replenish the five internal organs, harmonize the essence and nourish the spirit, calm the soul and soothe the spirit; Cinnamon can help the heart Yang, replenish the original Yang, dispel cold and rescue; Roasted Ephedra is pungent and sweet, enters the heart meridian, warms the Yang, promotes the Yang, and nourishes the defense; the three medicines are combined to warm and nourish the heart, spleen, and kidney, dispel cold and rescue. American ginseng replenishes the middle and replenishes the Qi, and helps Astragalus replenish the Qi and raise the Yang; Panax notoginseng replenishes the Qi, activates blood circulation and dredges the collaterals to relieve the problem of cold stagnation in the blood vessels; Asarum warms and unblocks the heart and kidneys, and is combined with cinnamon and ephedra. Ephedra enters the Taiyang meridian, cinnamon enters the Shaoyin meridian, and Asarum enters both meridians to communicate the inside and the outside. Exterior and interior, relieving exterior coldness on the outside and dispersing interior coldness on the inside, pungent and warming to promote growth, dispersing dampness and promoting blood circulation, the three herbs are used together to make the Tai and Shao meridians interact through the triple burner and the skin, thereby dispelling the coldness of Shaoyin and reaching the exterior of Taiyang; the above herbs are ministerial herbs. Cuscuta helps cinnamon to warm and nourish the kidney yang; Rhodiola rosea invigorates qi, activates blood circulation and dredges the meridians, and helps Panax notoginseng invigorate qi and activates blood circulation; Bupleurum and Cimicifuga invigorate yang and lift the sunken, helping the above herbs to raise the clear yang qi. Alpinia galanga warms the stomach and dispels coldness, and the combination of the herbs has the effects of warming and nourishing the heart and kidney, invigorating qi and raising yang, dispersing coldness and dredging the meridians. It has been clinically used for more than ten years, with remarkable efficacy.

[0142] This study, after 4 years of clinical randomized controlled studies, further confirmed the effect of the composition of the present invention on the treatment of bradyarrhythmias, and confirmed that the composition of the present invention not only improves the clinical symptoms of dizziness, fatigue, etc. in patients with bradyarrhythmias, but also can significantly increase the average heart rate and the slowest heart rate of the patient's 24-hour electrocardiogram, reduce the number of the longest duration of RR waves longer than 2 seconds, and shorten the number of seconds. It provides scientific evidence-based evidence for the treatment of bradyarrhythmias with good safety and has a wide range of clinical application value.

[0143] At present, there are relatively few Chinese patent medicines for the treatment of bradyarrhythmias on the market. Commonly used Chinese patent medicines include Xinbao Pills, Shensong Yangxin Capsules and Shengxian Oral Liquid. Shensong Yangxin Capsules contain Chinese herbs such as Rhizoma Aestivi, Eupolyphaga Seu Radix, Radix Ophiopogonis, Morus Alpiniae, Dragon Bone, Fructus Corni, Red Peony Root, Schisandrae Chinensis, Coptis chinensis and Salvia miltiorrhiza. They have the effects of nourishing qi and yin, promoting blood circulation and unblocking collaterals, and calming the mind. They are mainly used to treat coronary heart disease and ventricular premature beats. The symptoms are mainly seen in chest tightness, palpitations, shortness of breath, insomnia, night sweats, fatigue and weakness. They are mainly used to treat fast arrhythmias and bradyarrhythmias, such as sick sinus syndrome. Xinbao Pills are composed of borneol, toad venom, aconite, velvet antler, ginseng, cinnamon, Panax notoginseng, musk and datura flower. They have the effects of warming the heart and kidney, nourishing qi and yang, and promoting blood circulation and unblocking meridians. It is mainly used to treat chronic heart failure caused by deficiency of heart and kidney yang and blood stasis, bradycardia caused by sinus node dysfunction, sick sinus syndrome, angina pectoris and ischemic changes in electrocardiogram caused by ischemic heart disease. It is mainly used to treat heart failure and has a certain effect of increasing heart rate, but the effect is limited. Shenxian oral liquid is composed of red ginseng, epimedium, psoralea corylifolia (salt-roasted), wolfberry, ephedra, asarum, salvia miltiorrhiza, and leech, which warms the heart and kidney and promotes blood circulation and removes blood stasis. This product is used for yang deficiency and slow pulse syndrome, with symptoms of slow pulse, pulse knot, palpitations, chest tightness, fear of cold and cold limbs, soreness of waist and knees, shortness of breath, fatigue or dizziness, dull tongue or tooth marks, or ecchymosis and petechiae on the tongue. It is equivalent to mild and moderate bradycardia of sinus node (heart rate 50 times) and mild sick sinus syndrome without supraventricular tachyarrhythmia, deficiency of heart and kidney yang, cold blood stasis syndrome. The invention is used to treat patients with bradycardia mainly due to deficiency of heart and kidney yang. The granules of the invention are used to treat various bradycardias with deficiency of heart, spleen and kidney yang, deficiency of middle qi, cold coagulation of blood vessels, and blood stasis blocking collaterals, with symptoms of shortness of breath, laziness, shortness of breath, fatigue, dizziness, or syncope, or waking up at night, pale complexion, fear of cold and cold limbs, clear and long urine, dark tongue or ecchymosis, slow pulse or intermittent pulse, mainly warming and tonifying the heart, spleen and kidney, invigorating qi, raising yang and lifting depression, dispelling cold and unblocking collaterals, with better and wider functions and indications and application range.

[0144] The above detailed description is a specific description of one feasible embodiment of the present invention. The embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification that does not deviate from the present invention should be included in the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating bradyarrhythmia, characterized in that: By weight, the Chinese medicinal materials of the Chinese medicine composition are 20-45 parts of astragalus, 3-12 parts of ephedra, 3-10 parts of cinnamon, 3-12 parts of American ginseng, 3-12 parts of asarum, 1-6 parts of Panax notoginseng, 3-10 parts of rhodiola, 3-12 parts of bupleurum, 3-12 parts of cimicifuga and 1-10 parts of galangal.

2. The Chinese medicine composition according to claim 1, characterized in that: By weight, the Chinese medicinal materials of the Chinese medicine composition are 25-35 parts of astragalus, 3-9 parts of ephedra, 3-8 parts of cinnamon, 3-9 parts of American ginseng, 3-9 parts of asarum, 2-4 parts of Panax notoginseng, 5-9 parts of rhodiola, 3-9 parts of bupleurum, 3-9 parts of cimicifuga and 1-5 parts of galangal.

3. The Chinese medicine composition according to claim 1, characterized in that By weight, the Chinese medicinal materials of the Chinese medicine composition are 30 parts of astragalus, 6 parts of ephedra, 5 parts of cinnamon, 6 parts of American ginseng, 6 parts of asarum, 3 parts of Panax notoginseng, 6 parts of rhodiola, 6 parts of bupleurum, 6 parts of cimicifuga and 3 parts of galangal.

4. A method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The steps include: (1) extracting the Chinese medicinal materials except Panax notoginseng with water to obtain an extract; (2) preparing Panax notoginseng powder; (3) Mix the extract and Panax notoginseng powder to obtain the product.

5. The preparation method according to claim 4, characterized in that: The extraction in step (1) is performed by decoction, the number of decoctions is 1-3 times, the time of each decoction is 0.5-1.5 hours, and the amount of water added is 6-12 times the sum of the mass of the Chinese medicinal materials except Panax notoginseng.

6. A pharmaceutical preparation, characterized in that The invention comprises the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 5, and pharmaceutically acceptable excipients.

7. The pharmaceutical preparation according to claim 6, characterized in that The dosage form of the pharmaceutical preparation is granules, capsules, powders or tablets.

8. The pharmaceutical preparation according to claim 6, characterized in that The dosage form of the preparation is granules, the preparation of the granules adopts wet granulation, and the binder is ethanol with a volume concentration of 85-95%.

9. The pharmaceutical preparation according to claim 8, characterized in that The wet granulation method comprises the following steps: mixing the extracts of Chinese medicinal materials other than Panax notoginseng and Panax notoginseng powder; adding a binder to prepare a soft material; sieving and granulating, and drying to obtain the wet granulation product.

10. Use of the Chinese medicine composition according to any one of claims 1 to 3, or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 5, or the pharmaceutical preparation according to any one of claims 6 to 9 in the preparation of anti-bradyarrhythmia or anti-heart failure drugs.

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