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

Abstract

The invention discloses a traditional Chinese medicine composition for treating arrhythmia and a preparation method and application thereof. The composition is prepared from the following components in parts by weight: 150 to 250 parts of radix astragali seu hedysari, 100 to 200 parts of radix salviae miltiorrhizae, 50 to 100 parts of herba rhodiolae, 10 to 80 parts of radix notoginseng powder, 20 to 100 parts of fructus schisandrae chinensis, 60 to 120 parts of radix ilicis pubescentis, 120 to 220 parts of herba taxilli, 5 to 25 parts of rhizoma nardostachyos, 60 to 160 parts of flos sophorae, 100 to 200 parts of herba leonuri, 100 to 200 parts of caulis spatholobi, 50 to 150 parts of pine needle, 20 to 80 parts of fructus evodiae, 30 to 100 parts of gallnut, 320 to 520 parts of tea tree root, 70 to 120 parts of herba selaginellae and 80 to 180 parts of semen cuscutae. The traditional Chinese medicine composition has a good treatment effect on arrhythmia, is small in side effect, has small influence on the body of a patient after being taken, and can effectively solve the problems in the prior art.

Description

Technical Field

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

[0002] Cardiac arrhythmia refers to abnormalities in the frequency, rhythm, origin, conduction velocity or order of excitation of cardiac impulses. According to the principle of its occurrence, it can be divided into two categories: impulse formation abnormality and impulse conduction abnormality. According to the speed of the heart rate at which arrhythmias occur, they can be divided into two categories: tachyarrhythmias and bradyarrhythmias. Broadly speaking, tachyarrhythmias are also divided into two categories, supraventricular arrhythmias and ventricular arrhythmias. Therefore, tachyarrhythmias also involve atrial fibrillation, atrial premature beats, sinus tachycardia, ventricular premature beats, paroxysmal supraventricular tachycardia, etc.

[0003] Rapid arrhythmia is the most common type of arrhythmia encountered clinically. Arrhythmia is a cardiovascular disease with a high incidence rate. As far as the cardiovascular system is concerned, its disease incidence rate has reached the first place, ranking ahead of cancer. Therefore, its treatment and demand are increasing day by day. There are not many accurate Western medicines, and the side effects are large; Chinese medicine has few side effects in the treatment of arrhythmia, but most of the Chinese medicines on the market currently have the problem of poor treatment effect. Summary of the invention

[0004] In view of the above-mentioned deficiencies in the prior art, the present invention provides a Chinese medicine composition for treating arrhythmia and a preparation method and application thereof. The Chinese medicine composition has a good therapeutic effect on arrhythmia, has few side effects, and has little impact on the patient's body after taking it, which can effectively solve the problems existing in the prior art.

[0005] To achieve the above purpose, the technical solution adopted by the present invention to solve the technical problem is:

[0006] A Chinese medicine composition for treating arrhythmia comprises the following components in parts by weight: 150-250 parts of astragalus, 100-200 parts of salvia miltiorrhiza, 50-100 parts of rhodiola rosea, 10-80 parts of notoginseng powder, 20-100 parts of schisandra chinensis, 60-120 parts of ilex pubescens, 120-220 parts of parasitic lonicera, 5-25 parts of nardostachys grandiflora, 60-160 parts of sophora japonica, 100-200 parts of motherwort, 100-200 parts of millettia reticulata, 50-150 parts of pine needles, 20-80 parts of evodia rutaecarpa, 30-100 parts of gallnut, 320-520 parts of tea tree roots, 70-120 parts of selaginella and 80-180 parts of dodder seeds.

[0007] Further, the invention comprises the following components in parts by weight: 180-220 parts of astragalus, 140-160 parts of salvia miltiorrhiza, 70-85 parts of rhodiola rosea, 40-55 parts of panax notoginseng powder, 50-70 parts of schisandra chinensis, 80-100 parts of ilex pubescens, 170-190 parts of mistletoe, 17-20 parts of nardus galangus, 100-120 parts of sophora japonica, 140-160 parts of motherwort, 140-160 parts of millettia reticulata, 90-110 parts of pine needles, 45-55 parts of evodia rutaecarpa, 50-60 parts of gallnut, 320-520 parts of tea tree roots, 90-100 parts of selaginella and 120-140 parts of dodder seeds.

[0008] Further, the invention comprises the following components in parts by weight: 200 parts of astragalus, 150 parts of salvia miltiorrhiza, 75 parts of rhodiola rosea, 45 parts of notoginseng powder, 60 parts of schisandra chinensis, 90 parts of ilex pubescens, 170 parts of virulent herb, 19 parts of nardus sempervirens, 110 parts of sophora japonica, 150 parts of motherwort, 150 parts of millettia reticulata, 100 parts of pine needles, 50 parts of evodia rutaecarpa, 55 parts of gallnut, 410 parts of tea tree roots, 95 parts of selaginella and 130 parts of dodder seeds.

[0009] Further, the invention comprises the following components in parts by weight: 220 parts of astragalus, 140 parts of salvia miltiorrhiza, 70 parts of rhodiola rosea, 55 parts of notoginseng powder, 70 parts of schisandra chinensis, 80 parts of ilex pubescens, 190 parts of virulent herb, 17 parts of nardus odoratus, 100 parts of sophora japonica, 140 parts of motherwort, 160 parts of millettia reticulata, 110 parts of pine needles, 45 parts of roasted evodia rutaecarpa, 60 parts of gallnut, 480 parts of tea tree roots, 100 parts of selaginella and 120 parts of salt dodder seeds.

[0010] Furthermore, the Evodia rutaecarpa is roasted Evodia rutaecarpa.

[0011] Furthermore, the dodder seed is salt dodder seed.

[0012] The preparation method of the above-mentioned Chinese medicine composition for treating arrhythmia includes the steps of crushing the raw materials and then mixing them; or preparing the extract obtained by mixing or extracting the raw materials separately; or preparing the effective ingredient obtained by further refining and purifying the extract; or preparing the extract / effective ingredient by adding pharmaceutically acceptable excipients.

[0013] Furthermore, the prepared dosage form is one of pills, granules, capsules, powders, mixtures or oral liquids.

[0014] Furthermore, the specific preparation method is as follows: grind astragalus, salvia miltiorrhiza, gallnut, Sophora japonica, tea tree root, and Millettia reticulata into fine powder, then mix with Panax notoginseng powder, sieve, mix well, and set aside; add 10 times the amount of water to the remaining ten ingredients, including Rhodiola rosea, Morus alba, Nardostachys grandiflora, Leonurus japonicus, Schisandra chinensis, Cuscuta australis, pine needles, roasted Evodia rutaecarpa, Ilex pubescens, and Selaginella, boil twice, each time for 1.5 hours, combine the filtrate, filter, concentrate the filtrate to a relative density of 1.2 to 1.30 extract, mix it with the above-mentioned fine powder, dry it, grind it into fine powder, make pills, and dry it to obtain the extract.

[0015] Application of the above Chinese medicine composition in the preparation of medicine for treating arrhythmia.

[0016] The beneficial effects produced by the present invention are:

[0017] 1. In the present invention, astragalus and salvia miltiorrhiza are used as the main drugs. Astragalus invigorates qi and salvia miltiorrhiza invigorates blood circulation. The combination of the two can not only enhance blood circulation, but also clear the obstacles in circulation, and promote the correction of tachyarrhythmia; Rhodiola rosea invigorates qi and invigorates blood circulation, Panax notoginseng disperses blood stasis and invigorates blood circulation, Schisandra chinensis invigorates qi, invigorates the kidney and calms the heart, and Ilex pubescens invigorates blood circulation and dredges the meridians. The above are the ministerial drugs, which are used to enhance the effects of the main drugs invigorating qi and invigorating blood circulation;

[0018] Both mistletoe and salt dodder seed have the effect of nourishing the liver and kidney. The liver and kidney are of the same origin and are connected to the heart and kidney. Nourishing the liver and kidney will make them function well and nourish the heart, which can regulate heart function and play an auxiliary therapeutic role in heart disease; motherwort can promote blood circulation and regulate menstruation, clear away heat and detoxify, which can help improve the effect of the main medicine in promoting blood circulation and removing blood stasis, promote the smooth flow of qi and blood in the body, and help improve heart function; nard has the effect of regulating qi and invigorating the spleen, which can dredge the body's qi and promote blood circulation, and help improve heart function; pine needles have the effect of promoting blood circulation and calming the nerves, which can not only help promote blood circulation, but also soothe the heart and improve heart function; roasted wuzhu Cornus officinalis can dispel cold and relieve pain, warm the heart meridian, dispel cold and expel evil spirits, and improve the circulation of qi and blood in the heart; Selaginella can promote blood circulation and unblock menstruation, resolve blood stasis and stop bleeding, and can improve blood circulation in the heart, and promote the smooth flow of qi and blood in the heart; tea tree root can strengthen the heart, promote blood circulation and regulate menstruation, and can enhance the heart's contractility, reduce the burden on the heart, and improve heart function; Millettia spatholobi can promote blood circulation, replenish blood, regulate menstruation and activate collaterals, and can promote blood circulation in the heart, improve blood supply to the heart, and improve heart function; Gallnut can astringe the lungs and reduce sweat, and can improve the exogenous discomfort in patients with palpitations; the above-mentioned herbs can be used as adjuvants to improve the patient's heart function, and have a therapeutic effect on diseases caused by insufficient heart qi and blood stasis in the heart.

[0019] 2. In the present invention, astragalus, salvia miltiorrhiza, gallnut, sophora japonica, tea tree root, Millettia spatholobi and Panax notoginseng are used as medicine powder, which can increase the retention of effective ingredients in the above-mentioned medicinal materials and increase the content of effective ingredients in the medicine; extracting medicines such as Rhodiola rosea, Morus alba, Nardostachys grandiflora, Leonurus japonicus, Schisandra chinensis, Cuscuta australis, pine needles, roasted Evodia rutaecarpa, Ilex pubescens and Selaginella can fully extract the effective ingredients in the medicine and reduce the loss of effective ingredients; the medicine prepared by the method of the present invention has a good therapeutic effect on arrhythmia. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical scheme and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention, that is, the embodiments described are only part of the embodiments of the present invention, rather than all of the embodiments.

[0021] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative work are within the scope of protection of the present invention.

[0022] It should be noted that relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprises" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0023] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0024] Example 1

[0025] A traditional Chinese medicine composition for treating arrhythmia, composed of the following components in parts by weight: 200g of astragalus, 150g of salvia miltiorrhiza, 75g of rhodiola rosea, 45g of notoginseng powder, 60g of schisandra chinensis, 90g of ilex tomentosa, 170g of virulent herb, 19g of nardus galangus, 110g of sophora japonica, 150g of motherwort, 150g of millettia reticulata, 100g of pine needles, 50g of roasted evodia rutaecarpa, 55g of gallnut, 410g of tea tree root, 95g of selaginella and 130g of salt dodder seed.

[0026] The preparation method of the Chinese herbal medicine composition for treating arrhythmia comprises the following steps: grinding six herbs of astragalus, salvia miltiorrhiza, gallnut, sophora japonica, tea tree root and millettia spatholobi into fine powder, mixing with notoginseng powder, sieving, mixing and setting aside; adding 10 times amount of water to the remaining ten herbs of rhodiola rosea, moss parasitic herb, nard, motherwort, schisandra chinensis, salt dodder seed, pine needle, roasted evodia rutaecarpa, iris pubescens and selaginella, boiling twice, each time for 1.5 hours, combining the filtrate, filtering, concentrating the filtrate to a relative density of 1.30 extract, mixing with the above fine powder, drying, grinding into fine powder, making pills, drying to obtain the extract.

[0027] Example 2

[0028] A traditional Chinese medicine composition for treating arrhythmia, composed of the following components in parts by weight: 220g of astragalus, 140g of salvia miltiorrhiza, 70g of rhodiola rosea, 55g of notoginseng powder, 70g of schisandra chinensis, 80g of ilex pubescens, 190g of parasitic plant, 17g of nardus galangus, 100g of sophora japonica flower, 140g of motherwort, 160g of millettia spatholobi, 110g of pine needles, 45g of roasted evodia rutaecarpa, 60g of gallnut, 480g of tea tree root, 100g of selaginella and 120g of salt dodder seed.

[0029] The preparation method of the Chinese herbal medicine composition for treating arrhythmia comprises the following steps: grinding six herbs of astragalus, salvia miltiorrhiza, gallnut, sophora japonica, tea tree root and millettia spatholobi into fine powder, mixing with notoginseng powder, sieving, mixing and setting aside; adding 10 times amount of water to the remaining ten herbs of rhodiola rosea, moss parasitic, nard, motherwort, schisandra chinensis, salt dodder seed, pine needle, roasted evodia rutaecarpa, iris pubescens and selaginella, boiling twice, each time for 1.5 hours, combining the filtrate, filtering, concentrating the filtrate to a relative density of 1.2 extract, mixing with the above fine powder, drying, grinding into fine powder, making pills, drying to obtain the extract.

[0030] Example 3

[0031] A traditional Chinese medicine composition for treating arrhythmia, composed of the following components in parts by weight: 180g of astragalus, 160g of salvia miltiorrhiza, 85g of rhodiola rosea, 40g of notoginseng powder, 70g of schisandra chinensis, 80g of ilex tomentosa, 170g of virulent herb, 20g of nardostachys galanga, 120g of sophora japonica, 160g of motherwort, 140g of millettia reticulata, 90g of pine needles, 55g of roasted evodia rutaecarpa, 50g of gallnut, 320g of tea tree root, 90g of selaginella and 140g of salt dodder seed.

[0032] The preparation method of the Chinese herbal medicine composition for treating arrhythmia comprises the following steps: grinding six herbs of astragalus, salvia miltiorrhiza, gallnut, sophora japonica, tea tree root and millettia spatholobi into fine powder, mixing with notoginseng powder, sieving, mixing and setting aside; adding 10 times amount of water to the remaining ten herbs of rhodiola rosea, moss parasitic, nard, motherwort, schisandra chinensis, salt dodder seed, pine needle, roasted evodia rutaecarpa, iris pubescens and selaginella, boiling twice, each time for 1.5 hours, combining the filtrate, filtering, concentrating the filtrate to a relative density of 1.2 extract, mixing with the above fine powder, drying, grinding into fine powder, making pills, drying to obtain the extract.

[0033] Example 4

[0034] A traditional Chinese medicine composition for treating arrhythmia, composed of the following components in parts by weight: 250g of astragalus, 100g of salvia miltiorrhiza, 50g of rhodiola rosea, 80g of notoginseng powder, 100g of schisandra chinensis, 60g of ilex pubescens, 220g of virulent herb, 25g of nardus galanthus, 60g of sophora japonica, 200g of motherwort, 100g of millettia reticulata, 150g of pine needles, 20g of roasted evodia rutaecarpa, 100g of gallnut, 320g of tea tree root, 120g of selaginella and 80g of salt dodder seed.

[0035] The preparation method of the Chinese herbal medicine composition for treating arrhythmia comprises the following steps: grinding six herbs of astragalus, salvia miltiorrhiza, gallnut, sophora japonica, tea tree root and millettia spatholobi into fine powder, mixing with notoginseng powder, sieving, mixing and setting aside; adding 10 times amount of water to the remaining ten herbs of rhodiola rosea, moss parasitic, nard, motherwort, schisandra chinensis, salt dodder seed, pine needle, roasted evodia rutaecarpa, iris pubescens and selaginella, boiling twice, each time for 1.5 hours, combining the filtrate, filtering, concentrating the filtrate to a relative density of 1.2 extract, mixing with the above fine powder, drying, grinding into fine powder, making pills, drying to obtain the extract.

[0036] Comparative Example 1

[0037] A traditional Chinese medicine composition for treating arrhythmia, composed of the following components in parts by weight: 200g of astragalus, 150g of salvia miltiorrhiza, 75g of rhodiola rosea, 45g of notoginseng powder, 60g of schisandra chinensis, 90g of leech, 170g of parasitic plant, 150g of red peony root, 110g of sophora japonica flower, 150g of chuanxiong, 100g of pine needle, 50g of roasted evodia rutaecarpa, 55g of gallnut, 410g of tea tree root, 95g of julibrissin bark and 130g of salt dodder seed.

[0038] The preparation method of the Chinese herbal medicine composition for treating arrhythmia comprises the following steps: grinding six herbs including astragalus, salvia miltiorrhiza, gallnut, sophora japonica, tea tree root and red peony root into fine powder, mixing with notoginseng powder, sieving, mixing and setting aside; adding 10 times amount of water to the remaining ten herbs including rhodiola rosea, mistletoe, ligusticum chuanxiong, schisandra chinensis, salt dodder seed, pine needle, roasted evodia rutaecarpa, leech and julibrissin bark, boiling twice, each time for 1.5 hours, combining the filtrate, filtering, concentrating the filtrate to an extract with a relative density of 1.30, mixing with the above-mentioned fine powder, drying, grinding into fine powder, making pills and drying to obtain the extract.

[0039] Comparative Example 2

[0040] A traditional Chinese medicine composition for treating arrhythmia, composed of the following components in parts by weight: 200g of astragalus, 150g of salvia miltiorrhiza, 75g of rhodiola rosea, 45g of panax notoginseng powder, 90g of ilex pubescens, 15g of nardus galangus, 110g of sophora japonica, 150g of motherwort, 150g of millettia reticulata, 100g of pine needles, 50g of roasted evodia rutaecarpa, 55g of gallnut, 410g of tea tree root, and 95g of selaginella.

[0041] The preparation method of the above-mentioned traditional Chinese medicine composition for treating arrhythmia comprises the following steps: grinding six ingredients of astragalus, salvia miltiorrhiza, gallnut, sophora japonica, tea tree root and millettia spatholobi into fine powder, mixing with Panax notoginseng powder, sieving, mixing and setting aside; adding 10 times amount of water to the remaining ten ingredients of rhodiola rosea, nard, motherwort, pine needle, roasted evodia rutaecarpa, ilex tomentosa and selaginella, boiling twice, each time for 1.5 hours, combining the filtrate, filtering, concentrating the filtrate to a relative density of 1.30 extract, mixing with the above-mentioned fine powder, drying, grinding into fine powder, making pills, drying to obtain the extract.

[0042] Test example

[0043] 1. Clinical Cases

[0044] 1. General information: 120 patients with tachyarrhythmias were selected, including 30 patients with atrial fibrillation, 30 patients with supraventricular tachycardia, 30 patients with ventricular tachycardia, and 30 patients with premature beats, aged 18-65 years, with an average age of 59 years;

[0045] 2. Western medicine diagnostic criteria

[0046] Refer to "Internal Medicine" and "Clinical Electrocardiography", the details are as follows:

[0047] 2.1 Symptoms

[0048] Rapid arrhythmia can cause obvious palpitations, which are manifested as irregular pulsations in the precordial area, which may be continuous or intermittent, or accompanied by sudden skipping beats or a sudden sense of weightlessness. Occasionally, patients may not have any symptoms. In addition to the typical symptoms of palpitations, clinically, they are often accompanied by chest tightness, chest pain, fatigue, panic, anxiety, dizziness, etc. Continuous attacks are often accompanied by insufficient blood supply to other systems and organs. In severe cases, breathing difficulties, cold limbs, or convulsions may occur.

[0049] 2.2 Signs

[0050] Patients with tachyarrhythmias have a heart rate exceeding 100 beats per minute (normal for adults).

[0051] Premature ventricular contraction: Irregular heart rhythm on auscultation. A long compensatory interval occurs after premature contraction. The first heart sound is often enhanced, and the second heart sound is weakened or absent. Pulse palpation may reveal intermittent pulse absence.

[0052] Atrial fibrillation: extremely irregular heart rate. The intensity of the first heart sound is uncertain during auscultation. There may be a pulse shortness. The a wave of the carotid artery pulse disappears.

[0053] 2.3 Characteristic ECG

[0054] (1) Sinus tachycardia: The electrocardiogram shows normal sinus P waves, PP interval <0.60s, and P wave frequency >100 times / min.

[0055] (2) Atrial fibrillation: ① The electrocardiogram shows that there is no P wave in each lead, but instead there are small, fast and completely irregular atrial fibrillation waves (f waves) with a frequency of 350-600 times / minute; ② The QRS wave rhythm is irregular, making the RR interval completely unequal; ③ Auscultation of the heart can reveal that the heart rate is fast and slow, the heart sounds are of varying strengths, the rhythm is absolutely irregular, and the pulse is short.

[0056] (3) Atrial premature beats: ① The P-P interval may be normal, prolonged, or unable to be transmitted to the ventricles; ② The morphology and phase of the QRS complex are mostly normal, or the complex may be wide and deformed (intraventricular differential conduction); ③ The sum of the compensatory interval and the paired interval is often shorter than twice the sinus PP interval.

[0057] (4) Supraventricular tachycardia: ① Heart rate is 160-220 beats / min, rhythm is regular, atrial tachycardia has deformed P waves, PR interval is greater than 0.11s, and atrioventricular nodal tachycardia has no P waves or retrograde P waves, PR interval is less than 0.12s; ② QRS waves are normal. When it is impossible to determine whether it is atrial or atrioventricular nodal tachycardia, it is collectively referred to as supraventricular tachycardia.

[0058] (5) Ventricular premature beats: ① A wide and deformed QRS complex appears prematurely, with a duration ≥ 0.12s, and no related P wave before it; ② The ST segment and T wave are often in the opposite direction to the main QRS wave, and the compensatory interval is complete.

[0059] (6) Ventricular tachycardia: ① The QRS complex is wide and deformed, with a time difference of 0.12s; ② The frequency is 100-250 times / min, with regular or slightly irregular rhythm. It may be accompanied by ventricular-atrial dissociation, ventricular capture or ventricular fusion waves.

[0060] 3. TCM diagnostic criteria

[0061] According to the General Principles for Clinical Research of New Chinese Medicines and Traditional Chinese Medicine Internal Medicine, there are diagnostic standards for palpitations; and the syndrome diagnosis is in line with the Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes.

[0062] Main symptoms: palpitations, shortness of breath, chest tightness.

[0063] Secondary symptoms: shortness of breath, laziness to speak, fatigue, purple complexion, restlessness and insomnia.

[0064] Tongue and pulse: Tongue is pale purple, pulse is weak and astringent.

[0065] The diagnosis can be made based on 2 or more main symptoms and 2 or more secondary symptoms combined with tongue and pulse.

[0066] Quantitative Standards for TCM Syndrome Symptom Score

[0067] Main symptoms: mild (2 points), moderate (4 points), severe (6 points)

[0068]

[0069] Secondary symptoms: mild (1 point), moderate (2 points), severe (3 points)

[0070]

[0071]

[0072] 4. Inclusion criteria

[0073] (1) Those who meet the Western medical diagnostic criteria for tachyarrhythmia.

[0074] (2) Patients with Qi deficiency and blood stasis syndrome.

[0075] (3) Age: 18-65 years old.

[0076] 5. Exclusion criteria

[0077] (1) Those with a history of allergies.

[0078] (2) Slow arrhythmias and severe tachyarrhythmias (persistent atrial fibrillation with severe clinical symptoms, preexcitation syndrome, ventricular fibrillation, ront-type ventricular premature beats); patients with impaired cardiac function (grade III or below) and acute myocarditis.

[0079] (3) Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system diseases, and mental illness.

[0080] (4) Patients who have used other similar therapeutic drugs in the past two weeks.

[0081] (5) Pregnant or lactating women, or those with abnormal liver function (ALT / AST ≥ 60U / L).

[0082] (6) Patients who have undergone major surgery within the past two months or have bleeding tendencies such as cerebral hemorrhage.

[0083] 6. Treatment methods

[0084] Patients with each disease were divided into 3 groups, each with 10 patients. The patients in different groups were given the Chinese medicine compositions of Example 1, Comparative Example 1 and Comparative Example 2, respectively, once in the morning and evening every day, 6 g each time, for two consecutive weeks.

[0085] 7. Efficacy determination

[0086] 7.1 Determination of disease efficacy

[0087] The evaluation was conducted by referring to the Technical Guidelines for Clinical Research of Syndrome-Based New Chinese Medicines, Reference Standards for Causes, Severity and Efficacy of Common Arrhythmias, Holter Manual and the efficacy evaluation criteria in the 2016 European Society of Cardiology (ESC) Atrial Fibrillation Management Guidelines.

[0088] Marked effect: heart rate is controlled within 100 beats / min, or converted to sinus rhythm;

[0089] Effective: heart rate>100 beats / min, but reduced by 20% or more compared with the baseline heart rate at the initial diagnosis;

[0090] Ineffective: heart rate reduction is less than 20%;

[0091] Aggravation: Palpitations worsen and heart rate increases compared to baseline;

[0092] Total effective rate = [(number of markedly effective cases + number of effective cases) / total number of cases] × 100%;

[0093] 7.2 Determination of TCM Syndrome Efficacy

[0094] Refer to the "Guidelines for Clinical Research of New Chinese Medicines"

[0095] Markedly effective: Clinical symptoms and signs of TCM were significantly improved, and the syndrome score was reduced by ≥70%.

[0096] Effective: Clinical symptoms and signs of TCM were improved, and the syndrome score was reduced by 30%, <70%.

[0097] Ineffective: There is no significant improvement in TCM clinical symptoms and signs, or they may even get worse, and the syndrome score is reduced by less than 30%.

[0098] Worsening: TCM clinical symptoms and signs worsen, and syndrome score decreases to <0.

[0099] Calculation formula: Clinical symptom score reduction rate = (symptom and sign score before treatment - symptom and sign score after treatment) / symptom and sign score before treatment × 100%.

[0100] 8. Results

[0101] 8.1 Disease efficacy results

[0102] Table 3: Atrial fibrillation treatment outcomes

[0103]

[0104] Table 4: Supraventricular Tachycardia Treatment Outcomes

[0105]

[0106]

[0107] Table 5: VT Treatment Outcomes

[0108]

[0109] Table 6: Premature beats treatment results

[0110]

[0111] 8.2 TCM efficacy results

[0112] Table 7: Atrial fibrillation treatment outcomes

[0113]

[0114] Table 8: Supraventricular Tachycardia Treatment Outcomes

[0115]

[0116] Table 9: VT Treatment Outcomes

[0117]

[0118] Table 10: Premature beats treatment results

[0119]

[0120]

[0121] It can be seen from the data in the above table that the Chinese medicine composition in Example 1 has a good therapeutic effect on diseases caused by arrhythmia, while the therapeutic effect of the adjusted Chinese medicine composition in Comparative Example 1-2 is relatively poor, which proves that there is an interaction relationship between the components of the Chinese medicine composition in the present application.

[0122] 2. Animal Experiments

[0123] Based on the above results, the drug in Example 1 was subjected to animal experiments, and the specific operation was as follows:

[0124] 1. Experimental Materials

[0125] (1) Test drug: the pill in Example 1

[0126] (2) Positive drugs: Enteric-coated aspirin tablets, national medicine approval number H61023177, batch number 221130, specification 100 mg (content 25 mg) / tablet, produced by Shaanxi Bailu Pharmaceutical Co., Ltd.;

[0127] Compound Danshen Tablets, national medicine standard Z20123011, batch number: 230904, specification 0.32g / tablet, valid until August 2026, produced by Yunnan Qujing Pharmaceutical Co., Ltd.

[0128] (3) Animals: 50 KM mice, half male and half female, provided by the Experimental Animal Center of Xi'an Jiaotong University, certificate number: NO 3474, license number: SCXK(Shaanxi)2023-002;

[0129] 50 male SD rats were provided by Sibeifu (Beijing) Biotechnology Co., Ltd., quarantine certificate number: NO.1101087068, license number: SCXK (Beijing) 2019-0010.

[0130] 2. Drug configuration

[0131] Those skilled in the art know that the equivalent dose ratio of the body surface area of ​​humans to mice is 1:9.1, and the equivalent dose ratio of the body surface area of ​​humans to rats is 1:6.3, so the clinical equivalent dose of mice after conversion is 2.73 g / kg (0.3 g / kg×9.1), and the clinical equivalent dose of rats is 1.89 g / kg (0.3 g / kg×6.3). This dose is used as the middle dose, and the middle dose is doubled and halved respectively as the high dose and the low dose;

[0132] The dosage of the pills for mice in Example 1 was set to be 5.46, 2.73, and 1.37 g / kg (equivalent to 10.59, 5.30, and 2.66 g / kg of crude drug) for large, medium, and small doses, respectively; 2.8 g, 1.4 g, and 0.7 g of the ground powder were weighed, added to 10 ml of purified water, respectively, and shaken to obtain;

[0133] The dosage of the pills for rats in Example 1 was set to be 3.78, 1.89, and 0.945 g / kg (equivalent to 7.33, 3.67, and 1.83 g / kg of crude drug) for large, medium, and small doses, respectively; 9.45, 4.73, and 2.36 g of the ground powder were weighed, added to 10 ml of purified water, respectively, and shaken to obtain;

[0134] The microcirculation positive group used enteric-coated aspirin tablets, and the dosage was set at 480 mg per day. Based on a human body weight of 60 kg, the human dosage is 8 mg / kg. According to the equivalent dose ratio of human and mouse body surface area of ​​1:9.1, the clinical equivalent dose for mice is 72.8 mg / kg, which is converted into a concentration of 3.64 mg / mL. Weigh 36.4 mg of aspirin powder, add it to 10 ml of pure water, shake well, and prepare it.

[0135] The positive drug group of the blood stasis model selected Compound Danshen Tablets, and the dosage was set at 0.048 g / kg per day. According to the equivalent dose ratio of human and rat body surface area of ​​1:6.3, the clinical equivalent dose of rats was 0.3024 g / kg, about 0.3 g / kg, converted to a concentration of 0.03 mg / ml. Weigh 0.75 g of powder, add it to 25 ml of pure water, shake well, and prepare it.

[0136] 3. Experimental methods

[0137] 3.1 Effects on the auricle microcirculation of mice

[0138] Fifty healthy KM mice, half male and half female, weighing 18-22 g, were selected and randomly divided into 5 groups, 10 mice in each group, namely a blank group, a positive control group, a high-dose group of the pills of Example 1, a medium-dose group of the pills of Example 1, and a low-dose group of the pills of Example 1.

[0139] The mice were anesthetized with 0.17 mL / 10 g of 10% ulanose injected intraperitoneally (strictly disinfected), and fixed on the mouse observation platform with the abdomen facing downward, so that the auricle was flat on the ear tray, and a small amount of cedar oil was dripped on the ear tray and the surface of the auricle. The observation platform was placed on the microscope stage of the BI-2000 microcirculation observation system, and the brightness of the floodlight was adjusted to an appropriate level. The mice were observed under a 4x microscope, the microcirculation software was started, and the field of view under the microscope was adjusted to make the image transmitted from the camera to the computer screen clear. A certain boundary was selected near the marked point, and a blood vessel distribution sketch was drawn (in order to find the original measured blood vessel site during the next observation), and the capillary opening volume, blood flow velocity (μm / s), blood vessel input caliber (μm) and blood vessel output caliber (μm) were measured.

[0140] The mice were gavaged and administered from the same day. The blank control group was gavaged with 20 mL / kg of pure water, the positive control group was gavaged with 72.8 mg / kg of aspirin enteric-coated tablets, and the large, medium and small dose groups of the composition of Example 1 were gavaged with 5.46, 2.73 and 1.37 g / kg, respectively. The administration volume of each group was 20 mL / kg. The administration was continued for 7 days, once a day. After the 7th administration, the vascular opening volume, blood flow velocity, vascular input caliber and vascular output caliber of the original part of the mouse were measured at 30 and 60 minutes. The corresponding values ​​before administration were subtracted to obtain the change values ​​of vascular opening volume, blood flow velocity change value, and vascular input and output caliber change value. The t test was performed for inter-group comparison. The results are shown in Tables 11-15.

[0141] Analysis of experimental results: Compared with the blank group, the 5.46g / kg dose of the Chinese medicine composition in Example 1 significantly increased the number of open capillaries in the auricle of mice 30 and 60 minutes after administration (P<0.05 or P<0.01); the input and output calibers of the auricle capillaries of mice were significantly increased (P<0.05 or P<0.01); and the blood flow velocity of the artery and vein of mice was significantly accelerated 60 minutes after administration (P<0.05 or P<0.01). The 2.73g / kg dose significantly increased the number of open capillaries in the auricle of mice 30 and 60 minutes after administration (P<0.05); the input caliber of the auricle capillaries of mice was significantly increased 30 minutes after administration (P<0.05); the output caliber of the auricle capillaries of mice was significantly increased 60 minutes after administration (P<0.05), and the blood flow velocity of the artery and vein was significantly accelerated (P<0.05).

[0142] Table 11 Capillary opening volume and change value

[0143]

[0144]

[0145] Note: Compared with the blank group * P<0.05, ** P<0.01.

[0146] Table 12 Blood flow velocity (artery) and change value

[0147]

[0148] Note: Compared with the blank group * P<0.05, ** P<0.01.

[0149] Table 13 Blood flow velocity (venous) and change value

[0150]

[0151] Note: Compared with the blank group * P<0.05, ** P<0.01.

[0152] Table 14 Blood vessel input caliber and change value

[0153]

[0154]

[0155] Note: Compared with the blank group * P<0.05, ** P<0.01.

[0156] Table 15 Vascular output caliber and change value

[0157]

[0158] Note: Compared with the blank group * P<0.05, ** P<0.01.

[0159] 3.2 Effects on blood rheology in rats with acute blood stasis model

[0160] 3.2.1 Animal grouping and drug administration

[0161] 60 healthy male rats, weighing 150-170g, were raised normally to a weight of 170-200g and randomly divided into six groups, each with 10 rats. The first group was a blank control group, which was gavaged with 10mL / kg of pure water; the second group was a blood stasis model control group, which was gavaged with 10mL / kg of pure water; the third group was a positive drug control group, which was gavaged with 0.3g / kg of Compound Danshen Tablets (equivalent to 6.3 times the human dosage); the fourth to sixth groups were large, medium and small dose groups of the pills of Example 1, and the large dose group, medium and small dose groups were gavaged with 3.78, 1.89 and 0.945g / kg of pills per day, and the administration volume was 10mL / kg, and the administration was continued for 7 days, once a day.

[0162] 3.2.2 Reproduction of blood stasis rat model

[0163] With reference to the experimental methodology of traditional Chinese medicine pharmacology, the blood stasis rat model was replicated. 30 minutes after the last administration, except for the blank control group, the other groups were subcutaneously injected with 0.08 mg / 100 g of epinephrine hydrochloride. 2 hours after the injection, the rats were immersed in 0℃ ice water for 5 minutes, and then the water on the fur of the rats was wiped off. 2 hours later, except for the blank control group, the other groups were subcutaneously injected with 0.08 mg / 100 g of epinephrine hydrochloride again, and the model was completed.

[0164] After the modeling was completed, the subjects were fasted but not watered for 18 hours, anesthetized with 10% urethane solution 1.1 mL / 100 g intraperitoneally, the abdominal aorta was separated, 5 mL of blood was collected by cannulation, and the blood was allowed to flow naturally into a blood collection tube containing a small amount of sodium citrate. The blood was shaken while flowing to make the blood anticoagulated. The blood was tested on a 990JZ fully automatic blood viscosity analyzer. The room temperature was 22°C and the sample was kept at 37°C. After the whole blood viscosity was measured, it was centrifuged (3000 r / min for 10 minutes) to obtain plasma, and then the plasma viscosity, hematocrit and other indicators were measured. The comparison between the groups was performed by t test. The test results are shown in Tables 16-19.

[0165] 3.2.3 Results Analysis

[0166] As can be seen from Tables 16 to 19, compared with the blank group, the whole blood viscosity value, hematocrit, erythrocyte sedimentation equation K value, erythrocyte aggregation index, and erythrocyte electrophoresis time (s) of the model group were significantly increased (P﹤0.05 or P<0.01), and the erythrocyte sedimentation rate was significantly decreased (P<0.01), indicating that the model was successful. Compared with the model group, the whole blood viscosity value, red blood cell aggregation index, erythrocyte sedimentation equation K value, red blood cell electrophoresis time, and whole blood low shear reduction viscosity of the product at a dose of 3.78g / kg were significantly lower than those of the model group (P<0.05 or P<0.01), and the erythrocyte sedimentation rate was significantly higher than that of the model group (P<0.01); the whole blood viscosity value, plasma viscosity, hematocrit, erythrocyte sedimentation equation K value, red blood cell aggregation index, red blood cell electrophoresis time, and red blood cell deformation index of the product at a dose of 1.89g / kg were significantly lower than those of the model group (P<0.05 or P<0.01), and the erythrocyte sedimentation rate was significantly higher than that of the model group (P<0.01); the whole blood viscosity value, hematocrit, erythrocyte sedimentation equation K value, red blood cell electrophoresis time, and whole blood low shear reduction viscosity of the product at a dose of 0.945g / kg were significantly lower than those of the model group (P<0.05 or P<0.01). The above results indicate that the product has the effect of improving blood viscosity.

[0167] Tip: This product has a certain effect in improving blood rheology, and the effective dose is 0.945g / kg.

[0168] Table 16 Effect of Danqi Huoxin Pills on blood rheology in rats with acute blood stasis model

[0169]

[0170] Note: Compared with the blank group, the model group # P<0.05, ## P<0.01; comparison between drug-treated group and model control group * P<0.05, ** P<0.01.

[0171] Table 17 Effect of Danqi Huoxin Pills on blood rheology in rats with acute blood stasis model

[0172]

[0173] Note: Compared with the blank group, the model group # P<0.05, ## P<0.01; comparison between drug-treated group and model control group * P<0.05, ** P<0.01.

[0174] Table 18 Effect of Danqi Huoxin Pills on blood rheology in rats with acute blood stasis model

[0175]

[0176] Note: Compared with the blank group, the model group # P<0.05, ## P<0.01; comparison between drug-treated group and model control group * P<0.05, ** P<0.01.

[0177] Table 19 Effect of Danqi Huoxin Pills on blood rheology in rats with acute blood stasis model

[0178]

[0179] Note: Compared with the blank group, the model group # P<0.05, ## P<0.01; comparison between drug-treated group and model control group * P<0.05, ** P<0.01.

Claims

1. A Chinese medicine composition for treating arrhythmia, characterized in that: The invention comprises the following components in parts by weight: 150-250 parts of astragalus, 100-200 parts of salvia miltiorrhiza, 50-100 parts of rhodiola rosea, 10-80 parts of notoginseng powder, 20-100 parts of schisandra chinensis, 60-120 parts of ilex pubescens, 120-220 parts of mistletoe, 5-25 parts of nardostachys galanga, 60-160 parts of sophora japonica, 100-200 parts of motherwort, 100-200 parts of millettia reticulata, 50-150 parts of pine needles, 20-80 parts of evodia rutaecarpa, 30-100 parts of gallnut, 320-520 parts of tea tree roots, 70-120 parts of selaginella and 80-180 parts of dodder seeds.

2. The Chinese medicine composition for treating arrhythmia according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 180-220 parts of astragalus, 140-160 parts of salvia miltiorrhiza, 70-85 parts of rhodiola rosea, 40-55 parts of notoginseng powder, 50-70 parts of schisandra chinensis, 80-100 parts of ilex pubescens, 170-190 parts of mistletoe, 17-20 parts of nardus pinnatifida, 100-120 parts of sophora japonica, 140-160 parts of motherwort, 140-160 parts of millettia reticulata, 90-110 parts of pine needles, 45-55 parts of evodia rutaecarpa, 50-60 parts of gallnut, 400-500 parts of tea tree roots, 90-100 parts of selaginella and 120-140 parts of dodder seeds.

3. The Chinese medicine composition for treating arrhythmia according to claim 1 or 2, characterized in that: The invention comprises the following components in parts by weight: 200 parts of astragalus, 150 parts of salvia miltiorrhiza, 75 parts of rhodiola rosea, 45 parts of notoginseng powder, 60 parts of schisandra chinensis, 90 parts of ilex pubescens, 170 parts of virulent herb, 19 parts of nardus odoratus, 110 parts of sophora japonica, 150 parts of motherwort, 150 parts of millettia reticulata, 100 parts of pine needles, 50 parts of evodia rutaecarpa, 55 parts of gallnut, 410 parts of tea tree roots, 95 parts of selaginella and 130 parts of dodder seeds.

4. The Chinese medicine composition for treating arrhythmia according to claim 1 or 2, characterized in that: The invention comprises the following components in parts by weight: 220 parts of astragalus, 140 parts of salvia miltiorrhiza, 70 parts of rhodiola rosea, 55 parts of notoginseng powder, 70 parts of schisandra chinensis, 80 parts of ilex pubescens, 190 parts of virulent herb, 17 parts of nardus odoratus, 100 parts of sophora japonica, 140 parts of motherwort, 160 parts of millettia reticulata, 110 parts of pine needles, 45 parts of roasted evodia rutaecarpa, 60 parts of gallnut, 480 parts of tea tree roots, 100 parts of selaginella and 120 parts of salt dodder seeds.

5. The Chinese medicine composition for treating arrhythmia according to claim 1 or 2, characterized in that: The Evodia rutaecarpa described is roasted Evodia rutaecarpa.

6. The Chinese medicine composition for treating arrhythmia according to claim 1 or 2, characterized in that: The dodder seed is salt dodder seed.

7. The method for preparing the Chinese medicinal composition for treating arrhythmia according to any one of claims 1 to 6, characterized in that: It includes the steps of crushing and mixing the raw materials; or the extract obtained by mixing or extracting the raw materials separately; or the active ingredient obtained by further refining and purifying the extract; or the extract / active ingredient is added with pharmaceutically acceptable excipients.

8. The method for preparing the Chinese medicine composition for treating arrhythmia according to claim 7, characterized in that: The prepared dosage form is one of pills, granules, capsules, powders, mixtures or oral liquids.

9. The method for preparing the Chinese medicine composition for treating arrhythmia according to claim 7 or 8, characterized in that: The specific preparation method is as follows: grind astragalus, salvia miltiorrhiza, gallnut, Sophora japonica, tea tree root, and Millettia reticulata into fine powder, then mix with Panax notoginseng powder, sieve, mix well, and set aside; add water to the remaining ten ingredients, including Rhodiola rosea, Viscum album, Nardostachys grandiflora, Leonurus japonicus, Schisandra chinensis, Cuscuta australis, pine needles, roasted Evodia rutaecarpa, Ilex tomentosa, and Selaginella, boil the filtrate to a relative density of 1.2-1.30, mix the filtrate with the above-mentioned fine powder, dry, grind into fine powder, make pills, and dry to obtain the extract.

10. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a drug for treating arrhythmia.

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