A traditional Chinese medicine composition for treating ventricular premature beat, a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating ventricular premature beat and a preparation method thereof. The composition comprises the following raw materials: radix pseudostellariae, schisandra chinensis, rhizoma corydalis, radix notopterygii, polygala, lotus plumule, albizia julibrissin, calcined semen orystalis, gancao, radix scabiosae, and herba artemisiae annuae. The traditional Chinese medicine composition is suitable for patients with ventricular premature beat. The composition can be prepared into any common oral dosage form and health product, has the effects of benefiting qi and nourishing yin, regulating qi and activating blood, calming the nerves and stabilizing palpitation, can effectively improve the symptoms of the patients, and can significantly reduce the number of premature beats, and is especially suitable for the application to ventricular premature beat of qi-yin deficiency and blood stasis.

Description

TECHNICAL FIELD

[0001] The present application relates to a traditional Chinese medicine composition and a preparation method thereof, in particular to a traditional Chinese medicine composition for ventricular premature beat and a preparation method thereof, and belongs to the field of traditional Chinese medicine. BACKGROUND

[0002] Ventricular premature beat, also known as premature ventricular contractions (PVCs) for short, is a premature ventricular activation caused by ectopic pacemaker below His bundle branch, which is more common in middle-aged and elderly people.

[0003] Ventricular premature beat can be seen in normal people, and can be caused by mental stress and excessive fatigue. Ventricular premature beat is more common in patients with hypertension, coronary heart disease, acute myocardial infarction, cardiomyopathy, myocarditis, mitral valve prolapse, digitalis or quinidine poisoning, low blood potassium and the like.

[0004] Ventricular premature beat is generally sporadic and does not cause any discomfort. When ventricular premature contractions occur frequently or continuously, the cardiac output and perfusion of important organs can be reduced, and symptoms such as palpitation, chest tightness, fatigue, dizziness, sweating, angina pectoris or dyspnea can occur. When auscultation is performed, a sudden premature heart beat can be heard, the first heart sound is louder than normal, the second heart sound is weak or not heard, and then there is a long compensatory pause. Pulse diagnosis can touch the premature weak pulse, and then there is a long compensatory pause. Ventricular premature beat can be seen in patients with organic heart disease, and can also be seen in normal people without organic heart disease. When ventricular premature beat is found, 24-hour dynamic electrocardiogram (Holter) examination should be performed, and quantitative and qualitative analysis of ventricular premature contractions should be performed to evaluate and guide prognosis.

[0005] At present, the main ways to intervene ventricular premature beat include drug treatment, electric cardioversion and catheter ablation. The main action of drugs is to inhibit the outflow of sodium and potassium ions, block β1 receptor and calcium ion (Ca 2+ ) channel, inhibit the generation of action potential, and slow down its conduction. Commonly used drugs include metoprolol, mexiletine, amiodarone, propafenone, verapamil and the like. For patients with normal heart structure and function, β receptor blockers such as metoprolol, or Ca 2+ channel blockers such as verapamil can be used first. For patients with right ventricular outflow tract origin, symptoms, frequent occurrence and drug treatment invalid or unsuitable, catheter ablation treatment can be recommended; when cardiomyopathy is induced, catheter ablation treatment is also recommended. If the lesion is deep and standard ablation technology cannot penetrate, liquid needle ablation with deflectable catheter can also be considered. However, there is still about 18% recurrence rate within 3 years after radiofrequency ablation.

[0006] Western medicine for room early load is heavy, or have higher risk of patients, generally recommended to use electric cardioversion or radiofrequency ablation, but for multiple relapse patients, in addition to multiple radiofrequency and increase drug dosage, multi-drug combination, still lack of better methods and means. And for room early number of total number of heartbeats, that is, room early load less than 10% of asymptomatic low-risk patients, has not reached the application standard of western medicine, can only continue to observe, wait for disease progression.

[0007] The Chinese medicine composition of the present application is suitable for treating mild room early, especially for treating room early of deficiency of both qi and yin combined with blood stasis, and is not suitable for treating room early of other types. The Chinese medicine composition of the present application is suitable for treating mild room early, especially for treating room early of deficiency of both qi and yin combined with blood stasis, and is not suitable for treating room early of other types. The Chinese medicine composition of the present application is suitable for treating mild room early, especially for treating room early of deficiency of both qi and yin combined with blood stasis, and is not suitable for treating room early of other types.

[0008] The Chinese medicine composition of the present application is derived from the in-depth study of the prescriptions of national medical masters, which can effectively relieve the symptoms of palpitation, reduce the number of room early, and achieve the effect of treating disease before it occurs, preventing or slowing down the progression of the disease. SUMMARY

[0009] The primary object of the present application is to provide a Chinese medicine composition for treating room early and a preparation method thereof in view of the technical problems existing in the prior art in treating room early, especially in treating room early of deficiency of both qi and yin combined with blood stasis. The standardization and standardization of Chinese medicine, the accuracy of syndrome differentiation and treatment, the interaction of drugs, sufficient clinical research evidence, appropriate dosage form and administration method, clear indications and contraindications, and other technical problems need to be further optimized and improved. The Chinese medicine composition of the present application is aimed at the pathogenesis of room early, especially room early of deficiency of both qi and yin combined with blood stasis, and uses multiple traditional Chinese medicines to cooperate with each other, the active ingredients of which synergistically improve the clinical symptoms of room early, improve the pathological state of deficiency of both qi and yin combined with blood stasis, tonify qi and nourish yin, activate blood and dredge collaterals, and calm the mind and relieve palpitation. The composition of the present application has high efficacy in treating room early, significantly reduces the number of early beats, effectively improves the clinical symptoms, delays the progression of the disease and the occurrence of complications, and no toxic and side effects have been found in clinical use.

[0010] To achieve the object of the present application, the present application provides a Chinese medicine composition for treating room early, which comprises the following raw materials: radix pseudostellariae, schisandra chinensis, rhizoma corydalis, radix curcumae, polygala, lotus seed heart, albizia julibrissin, walnuts, gancao, silver radix scutellariae, chrysanthemum.

[0011] The raw materials are mixed in the following proportions by weight: Taizishen 10-20, Wuweizi 1-15, Yansu 5-25, Yujin 7-20, Yuanzhi 1-15, Lianxixin 1-20, Huhuapi 10-25, Waweizi 10-25, Gansong 10-20, Yincha-hu 5-15, Qinghao 5-15.

[0012] In particular, the raw materials are mixed in the following proportions by weight: Taizishen 12-15, Wuweizi 5-10, Yansu 12-15, Yujin 12-15, Yuanzhi 5-10, Lianxixin 5-10, Huhuapi 15-20, Waweizi 15-20, Gansong 12-15, Yincha-hu 10-12, Qinghao 10-12.

[0013] In particular, the raw materials are mixed in the following proportions by weight: Taizishen 12, Wuweizi 10, Yansu 15, Yujin 15, Yuanzhi 10, Lianxixin 10, Huhuapi 15, Waweizi 15, Gansong 12, Yincha-hu 12, Qinghao 10.

[0014] In particular, the premature ventricular contractions are preferably premature ventricular contractions of the type of deficiency of both qi and yin and blood stasis, wherein the deficiency of both qi and yin is characterized by the manifestations of deficiency of qi such as shortness of breath, weakness, spontaneous perspiration, reluctance to speak, aggravation of symptoms upon movement, and manifestations of deficiency of yin such as five heart heat, dry mouth and throat, profuse sweating, redness of both cheeks, constipation, dry skin, red tongue with little fur, and thin and rapid pulse; and the blood stasis is characterized by the clinical manifestations such as dark tongue or presence of blood stasis spots, dark lips, stabbing pain, angina, numbness or hemiplegia of limbs, dry skin, and absence of pulse.

[0015] In particular, the premature ventricular contractions are characterized by palpitation, chest distress, rapid heart rate, and tachyarrhythmia; and the tachyarrhythmia is commonly manifested by palpitation and chest distress.

[0016] In particular, the premature ventricular contractions refer to electrocardiogram or dynamic electrocardiogram in combination with symptoms and signs of the patient, and meet the diagnostic criteria of premature ventricular contractions.

[0017] The diagnosis of premature ventricular contractions is mainly based on clinical symptoms and electrocardiogram. The clinical manifestations of premature ventricular contractions are mainly palpitation, chest distress, rapid heart rate, and tachyarrhythmia. The mild premature ventricular contractions can also have no obvious clinical manifestations. Electrocardiogram or dynamic electrocardiogram shows premature ventricular contractions. Upon physical examination, the second heart sound can be found to be weakened, the radial artery pulse can be found to be weakened or disappeared, and the jugular vein can be found to have normal or large a wave. The ECG shows premature and large QRS wave, generally greater than 0.12 seconds; the directions of ST segment and T wave are opposite to that of QRS main wave; the interval between the sinus beats and the subsequent PVCs is constant.

[0018] In particular, the premature ventricular contractions of the deficiency of both qi and yin type are characterized by shortness of breath, lassitude, spontaneous perspiration, reluctance to speak, aggravation of symptoms on movement, manifestations of qi deficiency such as five heart heat, dry mouth and throat, profuse sweating, flushed cheeks, dry stool, dry skin, red tongue with little fur, and fine and rapid pulse, and manifestations of yin deficiency such as dry mouth and throat, profuse sweating, flushed cheeks, dry stool, dry skin, red tongue with little fur, and fine and rapid pulse.

[0019] The blood stasis syndrome is in accordance with one of the following main criteria or two of the following secondary criteria:

[0020] Main criteria: dark purple tongue or purpura, purpura or dark purple on the face, lips, gums, periorbital region, and the tips of fingers (toes), varicose veins or abnormal dilation of capillaries in different parts (such as the sublingual region, conjunctiva, fundus, oral mucosa, abdominal wall, lower limbs, digestive tract, etc.), blood stasis or hematoma in organs, tissues, subcutaneous tissue, or serous cavity caused by bleeding, intermittent claudication, abdominal tenderness and resistance, amenorrhea or dark and clotted menstruation, imaging showing blood vessel occlusion or moderate to severe stenosis (≥ 50%), not meeting the condition after interventional therapy or surgery, thrombosis, infarction or embolism, or objective evidence of organ ischemia.

[0021] Secondary criteria: fixed pain, or stabbing pain, angina, or pain at night, limb numbness or hemiplegia, dysmenorrhea, skin thickening, scaling, and increased, mental agitation or forgetfulness, pulse contraction or non-pulse, organ enlargement, neoplasm, inflammatory or non-inflammatory mass, tissue hyperplasia, imaging showing blood vessel stenosis (< 50%), abnormality in blood rheology, coagulation, fibrinolysis, and microcirculation, suggesting blood stasis, trauma, surgery, or artificial abortion in the past month.

[0022] In particular, the premature ventricular contractions are premature ventricular contractions of the deficiency of both qi and yin type with blood stasis.

[0023] In particular, the corrugated piece is a corrugated piece of calcined walnut; the raw medicinal materials are prepared into corresponding pieces of traditional Chinese medicine through processes such as material selection, cleaning, cutting, drying, processing, and pulverization.

[0024] In particular, the Corydalis tuber is selected as vinegar-cured Corydalis tuber; the corrugated piece is calcined walnut; the Polygala is selected as prepared Polygala, preferably prepared with licorice.

[0025] Vinegar-cured Corydalis tuber can enhance the effects of relieving palpitation and pain; raw corrugated pieces can dissipate blood stasis and resolve phlegm, and calcined corrugated pieces can inhibit gastric acid secretion and relieve pain, mainly for inhibiting the sour taste of Schisandra chinensis and other drugs; prepared Polygala, especially prepared with licorice, can reduce toxicity and enhance efficacy.

[0026] Chinese medicine researchers have actively explored and researched in the treatment of ventricular premature beat, and the relief of symptoms, mainly in the aspects of benefiting qi, nourishing yin, and promoting blood circulation, and the main drugs are ginseng, ophiopogon and schisandra. However, in clinical treatment, the inventor found that qi and yin deficiency and blood stasis often coexist, accompanied by meridian obstruction, etc., which is easy to cause other complications, and sleep and emotion are common influencing factors of the symptoms of ventricular premature beat palpitation.

[0027] The present application takes "benefiting qi and nourishing yin, promoting blood circulation and regulating qi, calming the nerves and relieving palpitation" as the treatment idea, and takes the therapeutic principle of treating the root and the branch to formulate the prescription, and is named "Shenwei Dingji Decoction", wherein Taizipen benefits qi and schisandra nourishes yin, and together supports the healthy qi of the human body; Corydalis, Yujin regulates qi, promotes blood circulation and relieves pain; Yuanzhi and Lianzhixing communicate the heart and kidney; Huanghuanpi relieves blood stasis and promotes blood circulation, and together plays the role of calming the nerves; Calcined Wengenzi relieves acid and relieves pain, and Gan Song regulates qi and wakes up the spleen, which relieves the symptoms of acid reflux, nausea, abdominal distension, poor appetite and other spleen and stomach discomfort; Yin Qianhu and Qinghao can soothe the liver and relieve depression, and relieve emotional anxiety.

[0028] In the present application, Taizipen benefits qi and schisandra nourishes yin, which is the root of the pathogenesis of palpitation due to deficiency of the healthy qi, and is the monarch drug. The minister drugs: Corydalis, Yujin regulate qi, promote blood circulation and relieve pain, relieve the obstruction of heart vessels and palpitation and pain; Yuanzhi and Lianzhixing communicate the heart and kidney, and Huanghuanpi relieves blood stasis and promotes blood circulation, which treat the complications of insomnia caused by palpitation; Yin Qianhu and Qinghao can soothe the liver and relieve depression, and relieve the complications of anxiety. The auxiliary drugs: Wengenzi relieves acid and relieves pain, which is the auxiliary drug, and Gan Song regulates qi and wakes up the spleen, which is the auxiliary drug, and the two drugs together relieve the symptoms of acid reflux, nausea, abdominal distension, poor appetite and other spleen and stomach discomfort.

[0029] Taizipen is the dry tuber of Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm. of the Stonecrop family. It tastes sweet and slightly bitter, and is flat in nature, and belongs to the spleen and lung meridians. "Yinpian Xinshen" calls it "tonifying spleen and lung, stopping sweating, and relieving palpitation". It has the effects of benefiting qi and invigorating the spleen, producing saliva and moistening the lungs, and can be used for treating spleen deficiency, loss of appetite, weakness after illness, deficiency of qi and yin, spontaneous sweating and thirst, and dry cough. The main components are cyclic peptides and polysaccharides, and modern pharmacological research shows that Taizipen has the functions of enhancing immunity, protecting myocardium and antioxidant.

[0030] Schisandra, the dried mature fruit of Schisandra chinensis (Turcz.) Baill. of Magnoliaceae, is acid and sweet in taste, warm in nature, and belongs to the lung, heart and kidney channels. It has the functions of astringing, tonifying, benefiting qi and producing saliva, and tonifying the kidney and calming the heart. It can be used for chronic cough, asthma, dream and seminal emission, frequent urination, chronic diarrhea, spontaneous and night sweating, dry mouth, internal heat and diabetes, palpitation and insomnia. Its main components are schisantherin A, lignans, polysaccharides, terpenoids, organic acids and volatile oils, etc. Modern pharmacological studies have shown that Schisandra has the effects of anti-tumor, anti-oxidation, anti-inflammation, etc., as well as anti-myocarditis, anti-oxidative damage, inhibition of myocardial cell apoptosis, and cardiovascular protection of relieving myocardial fibrosis.

[0031] Corydalis, also known as Yuhu, is the dried tuber of Corydalis yanhusuo W.T.Wang of Papaveraceae. It is bitter and warm in nature, and belongs to the liver and spleen channels. It is called "activating blood, benefiting qi, relieving pain and promoting urination" in Bencao Gangmu, and "treating heart pain and dying" in Leigong Paozhilun. It has the functions of activating blood, promoting qi and relieving pain, and can be used for chest and abdominal pain, chest pain, dysmenorrhea, postpartum blood stasis, sprains and swelling pain. Its main component is Corydalis B. Modern pharmacological studies have shown that Corydalis has the effects of analgesia, sedation and hypnotic, antitussive, anti-addiction, anti-anxiety and anti-depression, neuroprotective activity, and anti-epileptic effects, as well as improving blood rheology, promoting blood circulation, dilating blood vessels, anti-atherosclerosis, anti-myocardial ischemia and reperfusion injury, anti-arrhythmia, reducing blood pressure, myocardial protection and anti-thrombosis, and many other cardiovascular protective effects.

[0032] Yujin, the dried tuber of Curcuma wenyujin Y.H.Chen et C.Ling, Curcuma Longa L., Curcuma kwangsiensis S.G.Lee et C.F.Liang or Curcuma phaeocaulis Val. of Zingiberaceae, is bitter and cold in nature, and belongs to the liver, heart and lung channels. It has the functions of activating blood and relieving pain, promoting qi and relieving depression, clearing heart and blood, and promoting bile and reducing jaundice. It can be used for chest and abdominal pain, chest pain, dysmenorrhea, breast pain, delirium in febrile disease, epilepsy, blood heat and hemoptysis, and yellowish urine. Its main components are sesquiterpenes, monoterpenes, diterpenes and curcuminoids, etc. Modern pharmacological studies have shown that Yujin has the effects of anti-tumor, anti-inflammatory, anti-oxidation, antibacterial and antiviral activities, as well as the vascular protection effect of inhibiting platelet aggregation.

[0033] Yuanzhi (Polygala tenuifolia) is the dried root of *Polygala tenuifolia* Willd. or *Polygalasibirica* L., belonging to the Polygalaceae family. It tastes bitter and pungent, and is warm in nature, entering the heart, kidney, and lung meridians. It has the effects of calming the mind and improving intelligence, harmonizing the heart and kidneys, resolving phlegm, and reducing swelling. It can be used for insomnia, dreaminess, forgetfulness, palpitations, mental confusion, cough with phlegm, carbuncles, boils, and breast swelling and pain caused by disharmony between the heart and kidneys. Its main components are saponins, ketones, glycolipids, and organic acids. Modern pharmacological studies have shown that Yuanzhi has expectorant, sedative, anticonvulsant, diuretic, antibacterial, cAMP phosphodiesterase inhibitory, antimutagenic, and anticancer effects.

[0034] Albizia bark, the dried bark of the legume Albizia julibrissin Durazz., is sweet in taste and neutral in nature, and enters the heart, liver, and lung meridians. It has the effects of relieving depression and calming the mind, promoting blood circulation and reducing swelling, and can be used for restlessness, insomnia due to depression, lung abscess, sores, and injuries from falls. Its main components are triterpenoids, lignans, flavonoids, and sterols. Modern pharmacological studies have shown that Albizia bark has various pharmacological effects, including anti-tumor, antibacterial, anti-anxiety, antidepressant, anti-inflammatory, antifertility, immune-enhancing, and antioxidant properties.

[0035] Lotus seed heart, also known as lotus seed heart, is the dried young leaf and radicle of the mature seed of Nelumbo nucifera Gaertn., a plant in the Nymphaeaceae family. It has a bitter taste and cold nature, and enters the heart and kidney meridians. It possesses the effects of clearing the heart and calming the mind, harmonizing the heart and kidneys, astringing essence and stopping bleeding. It can be used for heat entering the pericardium, delirium, disharmony between the heart and kidneys, insomnia, seminal emission, and hematemesis due to blood heat. Its main active components are alkaloids and flavonoids, including methyl lotusine, norcodonine, nuciferine, lotusine quaternary ammonium alkaloids, total alkaloids, senna-carbon glycosides, rutin, hyperoside, and total flavonoids. Modern pharmacological studies have shown that lotus seed heart has anti-cancer, antihypertensive, antiarrhythmic, antioxidant and free radical scavenging, anti-fibrotic, anti-metabolic syndrome, neuroprotective, and anti-inflammatory effects.

[0036] Stellaria dichotoma L. var. lanceolata Bge., a plant in the Caryophyllaceae family, is a dried root. It has a sweet taste and slightly cold nature, and enters the liver and stomach meridians. It has the effects of clearing deficiency heat and eliminating infantile malnutrition fever, and can be used for yin deficiency fever, bone steaming fever, and infantile malnutrition fever. Its main components are sterols, cyclic peptides, alkaloids, flavonoids, phenolic acids, and volatile substances. Modern pharmacological studies have shown that Stellaria dichotoma has antipyretic, anti-inflammatory, and anti-allergic effects.

[0037] Artemisia annua L. of the family Asteraceae. It tastes bitter and pungent, and is cold in nature. It belongs to the meridians of liver and gallbladder. It has the functions of clearing virtual heat, eliminating bone steaming, relieving summer heat, stopping malaria, and reducing jaundice. It can be used for treating yin deficiency, night fever and early cool, yin deficiency fever, bone steaming and heat, summer heat, malaria, and jaundice. Its main components are sesquiterpenes, coumarins, alkaloids, and lignans, etc. Modern pharmacological studies have shown that Artemisia annua has the effects of anti-inflammatory, antibacterial, antiparasitic, antiviral, antitumor, and hypoglycemic effects.

[0038] Arca subcrenata Lischke, Arca granosa Linnaeus or Arca inflata Reeve. It tastes salty and is flat in nature. It belongs to the lung, stomach and liver meridians. It has the effects of resolving phlegm and blood stasis, softening and resolving masses, and relieving acid and pain. It can be used for treating stubborn phlegm and coagulation, viscous and difficult to cough, goiter, scrofula, and mass in the abdomen. Its main component is calcium carbonate. Modern pharmacological studies have shown that Arca and its effective components have the effects of neutralizing gastric acid to protect the gastric mucosa, anti-tumor, regulating immunity, and reducing blood pressure.

[0039] Nardostachys jatamansi DC. of the family Valerianaceae. It tastes bitter and pungent, and is warm in nature. It belongs to the spleen and stomach meridians. It is called "main evil qi, sudden abdominal pain" in Kaibao Bencao. It has the effects of regulating qi and relieving pain, and opening stagnation and activating the spleen. It can be used for treating abdominal distension, loss of appetite, and vomiting. It can also be used externally for treating toothache and foot swelling. Its main components are sesquiterpenes, pentacyclic triterpenes, iridoid glycosides, flavonoids, lignans, and coumarins, etc. Modern pharmacological studies have shown that Nardostachys jatamansi has the effects of regulating nerves, anti-inflammatory, antibacterial, antioxidant, metabolic regulation, anti-depression, anti-arrhythmia, sedation, and anti-inflammatory.

[0040] In another aspect of the present application, the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating or preventing premature ventricular contraction (i.e. premature ventricular contraction) is provided.

[0041] The premature ventricular contraction is premature ventricular contraction of qi and yin deficiency, premature ventricular contraction of qi and yin deficiency and blood stasis.

[0042] In still another aspect of the present application, a preparation method of a traditional Chinese medicine composition for treating premature ventricular contraction is provided, comprising the following steps:

[0043] 1) Prepare raw medicinal materials according to the following weight ratio:

[0044] Radix Pseudostellariae 10-20, Schisandra 1-15, Rhizoma Corydalis 5-25, Radix Anemarrhenae 7-20, Polygala 1-15, Lotus Plumule 1-20, Cortex Albiziae 10-25, Arca 10-25, Nardostachys jatamansi 10-20, Radix Stellariae 5-15, and Artemisia annua 5-15.

[0045] 2) adding raw medicine Gleditsia sinensis to water, heating to boiling, carrying out Gleditsia sinensis pre-decoction treatment, obtaining Gleditsia sinensis pre-decoction mixture;

[0046] 3) mixing raw medicine Radix Pseudostellariae, Schisandra chinensis, Rhizoma Corydalis, Radix Curcumae, Polygala tenuifolia, Semen Nelumbinis, Albizia julibrissin, Herba Gandineae, and Radix Stellariae to be uniform, then adding to Gleditsia sinensis pre-decoction mixture obtained in step 2), mixing water again, then heating, carrying out heating extraction treatment, and then filtering to obtain first extraction liquid and first drug residue;

[0047] 4) adding water to the first drug residue at least once, continuing heating extraction treatment at least once, and then filtering to mix the filtered liquid with the first extraction liquid to obtain mixed medicinal material extraction liquid;

[0048] 5) adding Artemisia vulgaris to the mixed medicinal material extraction liquid, heating, carrying out Artemisia vulgaris extraction treatment, and then filtering to obtain extraction liquid;

[0049] 6) carrying out concentration treatment on the extraction liquid to obtain active component.

[0050] In step 1), the weight ratio of the raw materials is as follows: Radix Pseudostellariae 12-15, Schisandra chinensis 5-10, Rhizoma Corydalis 12-15, Radix Curcumae 12-15, Polygala tenuifolia 5-10, Semen Nelumbinis 5-10, Albizia julibrissin 15-20, Gleditsia sinensis 15-20, Herba Gandineae 12-15, and Radix Stellariae 10-12.

[0051] In particular, the weight ratio of the raw materials is preferably as follows: Radix Pseudostellariae 12, Schisandra chinensis 10, Rhizoma Corydalis 15, Radix Curcumae 15, Polygala tenuifolia 10, Semen Nelumbinis 10, Albizia julibrissin 15, Gleditsia sinensis 15, Herba Gandineae 12, and Radix Stellariae 12.

[0052] In particular, the ratio of the weight of water added in step 2) to the weight (dry weight) of Gleditsia sinensis, a raw medicine (i.e. traditional Chinese medicine decoction pieces), is (8-10):1, preferably 9:1.

[0053] In particular, the temperature of the Gleditsia sinensis pre-decoction treatment is 60-100℃, preferably 90-100℃, and further preferably 100℃; and the pre-decoction treatment time is 0.5-1h.

[0054] In particular, the Gleditsia sinensis pre-decoction treatment is carried out after 20-90min of soaking treatment after adding water; and the soaking time is preferably 30min.

[0055] In particular, the ratio of the weight of water added in step 3) to the total weight (dry weight) of the mixed raw medicinal materials is (5-15):1, preferably (8-12):1, and further preferably (9-10):1, wherein the mixed raw medicinal materials are Radix Pseudoginseng, Schisandra chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Semen Nelumbinis, Cortex Albiziae, Radix Ledebouriellae, and Radix Stellariae.

[0056] In particular, the temperature of the heating extraction treatment in step 3) is 60-100°C, preferably 90-100°C, and further preferably 100°C; and the heating extraction treatment time is 1-2.5h.

[0057] In particular, the method further comprises, after adding water, performing a soaking treatment for 20-90min, and then performing the heating extraction treatment.

[0058] The mixed medicinal material extract is obtained according to the following steps:

[0059] A) The raw medicinal materials Radix Pseudoginseng, Schisandra chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Semen Nelumbinis, Cortex Albiziae, Radix Ledebouriellae, and Radix Stellariae are mixed, and the ratio of the weight of water added to the total weight of the raw medicinal materials Radix Pseudoginseng, Schisandra chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Semen Nelumbinis, Cortex Albiziae, Radix Ledebouriellae, and Radix Stellariae is (8-12):1. After soaking for 20-90min, the corrugated seed pre-extraction mixture prepared in step 2) is added, and a first heating extraction is performed at a heating extraction temperature of 100±2°C for a heating extraction time of 1-2.5h.

[0060] B) The first extraction is filtered to obtain a first extraction liquid.

[0061] C) The filtered residue is added with water at least once, and at least one heating extraction is continued, wherein the ratio of the weight of water added to the total weight of the raw medicinal materials Radix Pseudoginseng, Schisandra chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Semen Nelumbinis, Cortex Albiziae, Radix Ledebouriellae, and Radix Stellariae is (8-12):1. The heating extraction temperature is 100±2°C, the heating extraction time is 1-2.5h, and the second extraction liquid is obtained by filtering.

[0062] D) The first extraction liquid and the second extraction liquid are mixed to obtain the product.

[0063] In particular, the ratio of the weight of water added in step 4) to the total weight (dry weight) of the mixed raw medicinal materials is (8-12):1, and preferably (9-10):1, wherein the mixed raw medicinal materials are Radix Pseudoginseng, Schisandra chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Semen Nelumbinis, Cortex Albiziae, Radix Ledebouriellae, and Radix Stellariae.

[0064] In particular, the temperature of the heating extraction treatment in step 4) is 60-100°C, preferably 90-100°C, and further preferably 100°C; and the heating extraction treatment time is 1-2.5h per time.

[0065] In particular, the temperature of the heating extraction process in step 4) is 100±2℃; the heating extraction time is 1-2.5h.

[0066] In particular, the temperature of the heating extraction process in step 4) is 100±2℃; the heating extraction time is 1-2.5h.

[0067] In particular, the temperature of the heating extraction process in step 4) is 100±2℃; the heating extraction time is 1-2.5h.

[0068] In particular, step 5) further comprises adding water after adding the artemisia, wherein the ratio of the weight of the added water to the weight (dry weight) of the raw material artemisia is (0-12):1, preferably (0-9):1.

[0069] In particular, the concentration process in step 6) is performed under reduced pressure.

[0070] In particular, the relative pressure of the concentration process is less than 0MPa, preferably -0.05- -0.1MPa, preferably -0.07- -0.0095MPa. The concentration process temperature is 50-100℃, preferably 50-80℃.

[0071] In particular, the relative density of the concentrated solution after the concentration process in step 6) is 1.05-1.3, preferably 1.1-1.3, further preferably 1.1-1.2.

[0072] In particular, the concentration process refers to the evaporation concentration of the extraction liquid prepared in step 5) under vacuum, to remove water, wherein the concentration temperature is 70-100℃, preferably 70℃, and the relative pressure during the concentration process is -0.06- -0.08MPa, further preferably -0.07MPa.

[0073] In particular, the active component obtained by the concentration process is further dried to prepare a dry composition active component, to prepare a traditional Chinese medicine composition for treating ventricular premature beat.

[0074] The traditional Chinese medicine composition for premature ventricular contractions of qi-yin deficiency and blood stasis type of the application can be made into clinically acceptable oral dosage forms such as capsules, tablets, granules, pills, oral liquids, etc. by traditional or modern production processes with pharmaceutically acceptable excipients. The drug excipients used should meet the relevant requirements of the Chinese Pharmacopoeia, such as starch, dextrin, lactose, microcrystalline cellulose, gelatin, sucrose, magnesium stearate, etc. Long-term medication is needed in clinical practice, and solid preparations are convenient to store and easy for patients to take, which is more suitable for market demand. The preferred dosage form is capsule, granule, tablet, pill, powder, oral liquid, etc.

[0075] The traditional Chinese medicine composition prepared by the method of the application is aimed at the pathogenesis of premature ventricular contractions (especially premature ventricular contractions of qi-yin deficiency and blood stasis type), and adopts multiple traditional Chinese medicines to cooperate with each other, the active ingredients of which have synergistic effect, thereby effectively improving the pathological state of qi-yin deficiency and blood stasis, benefiting qi and nourishing yin, promoting blood circulation and relieving palpitation. The composition of the application has high curative effect on the treatment of premature ventricular contractions, and no side effects are found.

[0076] The traditional Chinese medicine composition for premature ventricular contractions of qi-yin deficiency and blood stasis type prepared by the application is used orally 2-3 times a day, 100 ml each time, pregnant women are prohibited from taking it, spicy food and alcohol are prohibited during medication, and the symptoms of palpitation are relieved after continuous use for 8-12 weeks, and the number of premature ventricular contractions indicated by Holter is effectively reduced.

[0077] The traditional Chinese medicine composition for premature ventricular contractions of qi-yin deficiency and blood stasis type of the application has the following advantages:

[0078] 1. The traditional Chinese medicine composition (Shanyi Dingji Decoction) of the application is aimed at the pathogenesis of premature ventricular contractions (especially premature ventricular contractions of qi-yin deficiency and blood stasis type) and symptomatic treatment, and the traditional Chinese medicine composition of the application is composed of multiple traditional Chinese medicine ingredients, the active ingredients of which can have synergistic effect. The radix pseudostellariae and fructus schisandrae chinensis in the composition of the application can treat the deficiency of the root of palpitation, radix corydalis and radix notopterygii are good at regulating qi, promoting blood circulation and relieving pain, which can effectively relieve the heart blood stasis caused by long-term illness and play a role in relieving palpitation and relieving pain. Polygala and lotus seed heart can transport heart and kidney and he huan skin can relieve blood stasis, which can treat insomnia and other complications caused by palpitation. Wa longzi can relieve acid and pain, and gancao can regulate qi and wake up the spleen, which can relieve symptoms such as acid reflux, nausea, abdominal distension, poor appetite and other symptoms of spleen and stomach. The radix scutellariae and artemisia vulgaris can soothe the liver and relieve depression, and relieve complications such as anxiety. It is especially suitable for the clinical syndrome of qi-yin deficiency and blood stasis. The traditional Chinese medicine composition of the application is aimed at the formation reason of premature ventricular contractions of qi-yin deficiency and blood stasis type, and adopts multiple link comprehensive treatment, which has good treatment effect and no side effect.

[0079] The radix pseudostellariae, fructus schisandrae chinensis and polygala in the traditional Chinese medicine composition of the application have the effect of benefiting qi and nourishing yin, and the radix corydalis and radix notopterygii have the effect of promoting blood circulation and relieving palpitation. These 5 medicines in the prescription are mainly aimed at the main symptoms (palpitation) of premature ventricular contractions.

[0080] 2、The traditional Chinese medicine composition of the present application has remarkable effect on treating ventricular premature beat, and can relieve symptoms of acid reflux, nausea, abdominal distension, poor appetite and other spleen and stomach discomfort due to the sedative and sleep-inducing effects of polygala, lotus seed heart and Chinese honeylocust bark, and the effects of relieving anxiety and relieving anxiety due to silver radix scabiosae and wormwood, so the whole prescription is especially suitable for ventricular premature beat combined with insomnia, anxiety and other complications, and weak spleen and stomach, and can more effectively treat ventricular premature beat, reduce the hospitalization rate of patients and delay further progression of the disease.

[0081] 3、The traditional Chinese medicine composition (Shenwei Dingji Granules) for treating ventricular premature beat of qi-yin deficiency and blood stasis type of the present application is derived from the experience prescription obtained by long-term exploration and optimization of researcher Mr. Weng Weiliang of Xiyuan Hospital of China Academy of Chinese Medical Sciences, and through long-term clinical practice, it is found that after taking the Shenwei Dingji Granules, the heart palpitation symptoms are significantly improved and the number of ventricular premature beat is reduced, and no adverse reactions are found after long-term use, and the Shenwei Dingji Granules have no toxic and side effects, the medication time is prolonged, the preparation process is simple, the product quality is stable and the effect is obvious, and the Shenwei Dingji Granules are convenient to use, and fill the gap in the market of traditional Chinese medicine for treating ventricular premature beat combined with insomnia, anxiety and other complications.

[0082] 4、The traditional Chinese medicine composition (Shenwei Dingji Granules) for treating ventricular premature beat of qi-yin deficiency and blood stasis type of the present application can achieve the purpose of soothing the nerves and calming palpitation by tonifying qi and nourishing yin, activating blood and unblocking collaterals, and pay more attention to the improvement of qi-yin deficiency and blood stasis type, and can effectively prevent ventricular premature beat from further causing cardiomyopathy, heart failure and other diseases and complications.

[0083] 5、The preparation method of the traditional Chinese medicine composition (Shenwei Dingji Granules) for treating ventricular premature beat of qi-yin deficiency and blood stasis type of the present application is simple, the process conditions are mild, the cost is low, the cost is low, the treatment cost of ventricular premature beat is reduced, the clinical health care cost is saved, it is suitable for market promotion and application, and more patients can benefit from it. DETAILED DESCRIPTION

[0084] The advantages and characteristics of the present application will be more clear with the description. However, these examples only serve as examples and do not constitute any limitation on the scope of the present application. Those skilled in the art should understand that the details and forms of the technical solutions of the present application can be modified or replaced without departing from the spirit and scope of the present application, and such modifications and replacements all fall within the protection scope of the present application.

[0085] The beneficial effects of the drug of the present application are further illustrated by the following test examples, which include clinical tests of the drug of the present application.

[0086] Example 1 Preparation of Shenwei Dingji Granules

[0087] 1) Prepare raw medicinal materials according to the following weight ratio (unit: x 10g):

[0088] Corydalis 15, Radix Anemarrhenae 15, Radix Pseudostellariae 12, Schisandra 10, Polygala 10, Lotus Plumule 10, Albizia 15, Walnuts 15, Gastrodia 12, Silver Radix Bupleuri 12, Artemisia 10.

[0089] The raw material used in the present application is traditional Chinese medicine decoction pieces, the corydalis is vinegar corydalis, the walnuts are calcined walnuts, and the polygala is licorice polygala.

[0090] 2) Walnuts are first decocted

[0091] The calcined walnuts are soaked in water, and the ratio of the weight of the water added to the weight of the traditional Chinese medicine decoction pieces walnuts is 9:1 (usually (8-10):1). After soaking for 30 min (usually 20-90 min), the power of the traditional Chinese medicine multifunctional extraction kettle is turned on for heating. The walnuts are first decocted until boiling. The first decoction temperature of the walnuts is 100℃ (usually 100±2℃), and the first decoction time is 45 min (usually 30-60 min).

[0092] 3) Heating extraction treatment

[0093] 3A) The traditional Chinese medicine decoction pieces Radix Pseudostellariae, Schisandra, corydalis, Radix Anemarrhenae, polygala, lotus plumule, Albizia, Gastrodia, and Silver Radix Bupleuri are mixed and placed in the traditional Chinese medicine multifunctional extraction kettle. Then, the first decoction mixture of walnuts is added and mixed evenly. After that, the mixture is soaked in water for 30 min (usually 20-90 min). The ratio of the weight of the water added to the total weight (dry weight) of the mixture of medicinal materials is 9:1 (usually (8-12):1). The mixture of medicinal materials is Radix Pseudostellariae, Schisandra, corydalis, Radix Anemarrhenae, polygala, lotus plumule, Albizia, Gastrodia, and Silver Radix Bupleuri.

[0094] 3B) The power of the multifunctional extraction kettle is turned on for heating until boiling. The first heating extraction treatment of the medicinal materials is performed. The first heating extraction treatment temperature is 100℃ (usually 100±2℃). The temperature is maintained at 100℃ (usually 100±2℃) during the first heating extraction process. The constant temperature extraction time is 2 h (usually 1-2.5 h). Then, the first extraction liquid and the first dregs are obtained by filtration.

[0095] 3C) Water is added to the first dregs, and the second heating extraction treatment is continued. The ratio of the weight of the water added to the total weight (dry weight) of the mixture of medicinal materials is 8:1 (usually (8-12):1). The second heating extraction treatment temperature is 100℃ (usually 100±2℃). The extraction time is 2.5 h (usually 1-2.5 h). Then, the filtrate is mixed with the first extraction liquid to obtain the mixed medicinal material extraction liquid.

[0096] The heating extraction temperature is not limited to 100℃, and other temperatures (such as 60-100℃, preferably 90-100℃) are also suitable for the present application.

[0097] 4) Artemisia annua extraction treatment

[0098] Artemisia annua is added to the mixed medicinal material extract, and water is added and uniformly mixed, the ratio of the weight of the added water to the weight of the raw material Artemisia annua is 9:1 (usually (0-12):1, preferably (0-9):1), the power of the multifunctional extraction kettle is turned on for heating, and the Artemisia annua extraction treatment is carried out by boiling, wherein the temperature of the Artemisia annua extraction treatment is 100℃ (usually 100±2℃), and the temperature is kept at 100℃ (usually 100±2℃) for 10 minutes (usually 10-15 minutes), and then filtered to obtain an extracted liquid and a filter residue;

[0099] During the Artemisia annua extraction treatment, water can also not be added. If the amount of water added during the heating extraction treatment in step 3) is large, water can not be added during the Artemisia annua extraction treatment.

[0100] 5) Concentration treatment

[0101] The extracted liquid is placed in a vacuum high-energy evaporation concentrator, and concentration treatment is carried out under reduced pressure to obtain a concentrated liquid, wherein the relative pressure of the concentration treatment is -0.07 MPa (i.e. taking one atmosphere as 0, the pressure relative to one atmosphere is -0.07 MPa during control of reduced pressure concentration), the concentration temperature is 70℃ (usually 50-80℃), and the relative density of the concentrated liquid is 1.15 (usually 1.05-1.3).

[0102] The relative pressure during the concentration treatment is usually less than 0 MPa, and is preferably -0.05 to -0.1 MPa.

[0103] The present application adopts the method of reduced pressure evaporation concentration for the concentration treatment of the extracted liquid. In addition to reduced pressure evaporation concentration, the concentration methods known in the art are also suitable for the present application, such as heating and evaporation under normal pressure.

[0104] 6) The concentrated liquid is dried at 80-90℃, dried to a water content of 5% (usually less than 5%, preferably 1-4%), and then crushed and sieved through a 100 mesh sieve, and the undersize is the extract dry paste powder, and the particle size of the extract dry paste powder is ≤100 mesh.

[0105] 7) The extract dry paste powder and the auxiliary material dextrin are mixed, ethanol is used as a binder, granulation is carried out, and drying is carried out, and the Chinese medicine Shenwei Dingji granules for treating ventricular premature beat of the present application are prepared.

[0106] Example 2 Shenwei Dingji Pill Preparation

[0107] 1) Prepare raw medicine according to the following weight ratio (unit: x10g):

[0108] Radix pseudoginseng 15, Schisandra 5, Corydalis 12, Radix notoginseng 12, Polygala 5, Lotus plumule 5, Albizia 20, Walnuts 20, Gansong 15, Silver Radix Bupleuri 10, Artemisia 12.

[0109] 2) Walnuts decoction treatment

[0110] Except that the weight ratio of the added water to the weight of the traditional Chinese medicine decoction pieces walnuts is 8:1; soak for 60 minutes; the walnuts decoction treatment time is 60 minutes; the rest is the same as step 2) "Walnuts decoction treatment" of Example 1;

[0111] 3) Heating extraction treatment

[0112] 3A) Mix the traditional Chinese medicine decoction pieces Radix pseudoginseng, Schisandra, Corydalis, Radix notoginseng, Polygala, Lotus plumule, Albizia, Gansong, and Silver Radix Bupleuri, then add the walnuts decoction mixture and mix evenly, then add water and soak for 60 minutes (usually 20-90 minutes), wherein the weight ratio of the added water to the total weight (dry weight) of the medicinal material mixture is 8:1;

[0113] 3B) Turn on the power of the multifunctional extraction kettle and heat to boiling, and perform the first heating extraction treatment on the medicinal materials, wherein the first heating extraction treatment temperature is 100°C (usually 100±2°C), and the temperature is maintained at 100°C (usually 100±2°C) during the first heating extraction process, and the constant temperature extraction is 2h (usually 1-2.5h); then filter to obtain the first extraction liquid and the first drug residue;

[0114] 3C) Add water to the first drug residue and continue heating for the second heating extraction treatment, wherein the weight ratio of the added water to the total weight (dry weight) of the medicinal material mixture is 8:1 (usually (8-12):1); the second heating extraction treatment temperature is 100°C (usually 100±2°C); the extraction time is 2.5h (usually 1-2.5h); then filter and mix the filtrate with the first extraction liquid to obtain the mixed medicinal material extraction liquid;

[0115] The heating extraction temperature is not limited to 100°C, and other temperatures such as 60-100°C (preferably 90-100°C) are also applicable to the present application.

[0116] 4) Artemisia extraction treatment

[0117] Except that no water is added; the constant temperature extraction time of Artemisia is 15 minutes; the rest is the same as step 4) "Artemisia extraction treatment" of Example 1.

[0118] 5) Concentration treatment

[0119] The relative pressure of the concentration treatment is -0.05 MPa, the concentration temperature is 80°C (usually 50-80°C), and the relative density of the concentrated solution is 1.05, except that the rest is the same as step 5) "concentration treatment" of example 1.

[0120] 6) The concentrated solution is spray dried to obtain the extract dry powder;

[0121] 7) The extract dry powder and the excipient invert sugar are mixed, stirred uniformly, and then placed in a pill making machine for pill making, and then dried to obtain the concentrated pill of the Chinese medicine Shenwei Dingji for treating ventricular premature beat of the application.

[0122] Preparation of Shenwei Dingji tablets of example 3

[0123] 1) Prepare raw medicinal materials according to the following weight ratio (unit: ×10g)

[0124] Radix pseudostellariae 20, Schisandra chinensis 1, Corydalis 5, Radix curcumae 20, Polygala 15, Lotus plumule 1, Albizia 25, Walnuts 25, Gastrodia 10, Silver Radix scabiosa 5, Artemisia 5.

[0125] Corydalis is acetic corydalis; walnuts are calcined walnuts; polygala is polygala prepared with licorice.

[0126] 2) Walnuts are first decocted

[0127] Except that the ratio of the weight of water added to the weight of Chinese herbal pieces walnuts is 10:1, the soaking time is 30 min, and the first decoction treatment time of walnuts is 30 min, the rest is the same as step 2) "first decoction treatment of walnuts" of example 1;

[0128] 3) Heating extraction treatment

[0129] 3A) Mix the Chinese herbal pieces radix pseudostellariae, Schisandra chinensis, corydalis, radix curcumae, polygala, lotus plumule, albizia, gastrodia, and silver radix scabiosa, then add the first decoction mixture of walnuts, mix well, then soak in water for 30 min (usually 20-90 min), wherein the ratio of the weight of water added to the total weight (dry weight) of the medicinal material mixture is 9:1;

[0130] 3B) Turn on the power of the multifunctional extraction kettle to heat to boiling, and perform the first heating extraction treatment on the medicinal materials, wherein the first heating extraction treatment temperature is 100°C (usually 100±2°C), the temperature is kept at 100°C (usually 100±2°C) during the first heating extraction treatment, and the constant temperature extraction is 2h (usually 1-2.5h); then filter to obtain the first extraction liquid and the first drug residue;

[0131] 3C) to the first residue, add water, continue heating, and perform a second heating extraction process, wherein the ratio of the weight of the added water to the total weight (dry weight) of the medicinal material mixture is 8:1 (usually (8-12):1); the temperature of the second heating extraction process is 100°C (usually 100±2°C); the extraction time is 2.5h (usually 1-2.5h); then filter, and mix the filtrate with the first extraction liquid to obtain a mixed medicinal material extraction liquid;

[0132] The heating extraction temperature is not limited to 100°C, and other temperatures such as 60-100°C (preferably 90-100°C) are also suitable for use in the present application.

[0133] 4) Artemisia annua extraction process

[0134] Except that no water is added; the constant temperature extraction time of Artemisia annua is 10 min, and the rest is the same as step 4) "Artemisia annua extraction process" of Example 1.

[0135] 5) Concentration process

[0136] Except that the relative pressure of the concentration process is -0.095 MPa, the concentration temperature is 50°C (usually 50-80°C), and the relative density of the concentrated liquid is 1.15, and the rest is the same as step 5) "concentration process" of Example 1.

[0137] 6) The concentrated liquid is dried at 80-90°C, dried to a water content of 4% (usually less than 5%, preferably 1-4%), then pulverized, and sieved through a 100-mesh sieve, and the undersize is the extract dry paste powder of the composition of the present application, and the particle size of the extract dry paste powder is ≤100 mesh;

[0138] 7) Mix the extract dry paste powder and the excipient dextrin, granulate with ethanol, dry, and tablet the tablet press to obtain the traditional Chinese medicine Shenwei Dingji tablet for treating ventricular premature beat of the present application.

[0139] Preparation of Shenwei Dingji capsule of Example 4

[0140] 1) Prepare raw medicinal materials according to the following weight ratio (unit: x10g)

[0141] Radix Pseudostellariae 10, Schisandra chinensis 15, Corydalis 25, Curcuma 7, Polygala 1, Nelumbinis Plumula 20, Albizia 10, Waltheria 10, Gastrodia 20, Silver Radix Bupleuri 15, Artemisia annua 15.

[0142] Corydalis is acetic corydalis; Waltheria is calcined waltheria; and Polygala is prepared Polygala.

[0143] 2) Waltheria pre-extraction process

[0144] The same as step 2) "Waltheria pre-extraction process" of Example 1.

[0145] 3) Heating extraction treatment

[0146] 3A) The traditional Chinese medicine decoction pieces Taizipian, Wuweizi, Yansu, Yujin, Yuanzhi, Lianzhixin, Huhuankpi, Gansong, Yincha-hu are mixed, then the corrugated box is added to the mixed decoction pieces, and then water is added to soak for 90 min (usually 20-90 min), wherein the ratio of the weight of water added to the total weight (dry weight) of the mixed decoction pieces is 12:1;

[0147] 3B) The power of the multifunctional extraction kettle is turned on for heating, and the decoction pieces are heated to boiling for the first heating extraction treatment, wherein the first heating extraction treatment temperature is 100°C (usually 100±2°C), the temperature is kept at 100°C (usually 100±2°C) during the first heating extraction process, and the constant temperature extraction is 1 h (usually 1-2.5 h); then the first extraction liquid and the first residue are obtained by filtration;

[0148] 3C) Water is added to the first residue, and heating is continued for the second heating extraction treatment, wherein the ratio of the weight of water added to the total weight (dry weight) of the mixed decoction pieces is 12:1 (usually (8-12):1); the second heating extraction treatment temperature is 100°C (usually 100±2°C); the extraction time is 1 h (usually 1-2.5 h); then the filtrate is mixed with the first extraction liquid to obtain the mixed decoction extraction liquid.

[0149] 4) Artemisia annua extraction treatment

[0150] Artemisia annua is added to the mixed decoction extraction liquid without water, and is directly mixed uniformly, the power of the multifunctional extraction kettle is turned on for heating, and the Artemisia annua extraction treatment is carried out by heating to boiling, wherein the Artemisia annua extraction treatment temperature is 100°C (usually 100±2°C), the temperature is kept at 100°C (usually 100±2°C), and the constant temperature extraction is 15 min (usually 10-15 min), then the extraction liquid and the filter residue are obtained by filtration;

[0151] 5) Concentration treatment

[0152] Except that the relative density of the concentrated liquid is 1.3, the rest is the same as step 5) "concentration treatment" of example 1.

[0153] 6) The concentrated liquid is dried at 80-90°C, and after drying to a water content of 5% (usually less than 5%, preferably 1-4%), it is crushed and sieved through a 100 mesh sieve, and the undersize is the extract dry paste powder of the composition of the present application, and the particle size of the extract dry paste powder is ≤100 mesh;

[0154] 7)mixing the extract dry paste powder and the excipient microcrystalline fiber, granulating, and loading into a gelatin hard capsule to obtain the Shenweidingji Capsule for treating ventricular premature beat according to the present application.

[0155] Preparation of Shenweidingji Oral Liquid

[0156] 1)Prepare raw medicinal materials according to the following weight ratio (unit: x 10g):

[0157] Radix pseudostellariae 12, Schisandra chinensis 10, Corydalis 15, Curcuma 15, Polygala 10, Lotus plumule 10, Albizia 15, Walnuts 15, Gastrodia 12, Silver Radix Bupleuri 12, Artemisia 10.

[0158] Corydalis is vinegar corydalis; Walnuts is calcined walnuts; Polygala is prepared polygala.

[0159] 2)Walnuts first decoction processing

[0160] Except that the weight ratio of added water to the weight of traditional Chinese medicine decoction pieces walnuts is 9:1, the soaking time is 30 min, and the walnuts first decoction processing time is 60 min, the rest is the same as step 2) "Walnuts first decoction processing" of example 1;

[0161] 3)Heating extraction processing

[0162] 3A)Mix the traditional Chinese medicine decoction pieces Radix pseudostellariae, Schisandra chinensis, Corydalis, Curcuma, Polygala, Lotus plumule, Albizia, Gastrodia, and Silver Radix Bupleuri, and then add the walnuts first decoction mixture, mix well, and then add water to soak for 30 min (usually 20-90 min), wherein the weight ratio of added water to the total weight (dry weight) of medicinal material mixture is 9:1 (usually (8-12):1);

[0163] 3B)Turn on the power of the multifunctional extraction kettle to heat to boiling, and perform the first heating extraction processing on the medicinal materials, wherein the first heating extraction processing temperature is 100°C (usually 100±2°C), and during the first heating extraction process, the temperature is kept at 100°C (usually 100±2°C) for constant temperature extraction for 2.5h (usually 1-2.5h); then filter to obtain the first extraction liquid and the first drug residue;

[0164] 3C)Add water to the first drug residue and continue heating for the second heating extraction processing, wherein the weight ratio of added water to the total weight (dry weight) of medicinal material mixture is 8:1 (usually (8-12):1); the second heating extraction processing temperature is 100°C (usually 100±2°C); the extraction time is 2.5h (usually 1-2.5h); then filter and mix the filtrate with the first extraction liquid to obtain the mixed medicinal material extraction liquid;

[0165] 4) Artemisia argyi extraction treatment

[0166] Add Artemisia argyi decoction pieces to the mixed medicinal extract, do not add water, mix directly, turn on the power of the multifunctional extraction kettle, heat to boiling, and perform Artemisia argyi extraction treatment. The temperature of Artemisia argyi extraction treatment is 100°C (usually 100±2°C), and the temperature is kept at 100°C (usually 100±2°C) for 15 min (usually 10-15 min). Then filter to obtain the extracted medicinal liquid and filter residue.

[0167] 5) Concentration treatment

[0168] The same as step 5) "concentration treatment" of Example 1.

[0169] 6) Take the concentrated liquid to prepare the liquid, fill, sterilize, and prepare the Chinese medicine Shenwei Dingji oral liquid (Shenwei Dingji decoction) for treating ventricular premature beat of the application.

[0170] Test Example 1 Clinical efficacy observation of Shenwei Dingji decoction

[0171] 1) Research object

[0172] From November 12, 2017 to December 31, 2022, patients with ventricular premature beat treated with Shenwei Dingji prescription in Professor Ong Wee Liang's outpatient department of Xiyuan Hospital of China Academy of Chinese Medical Sciences were observed. Patients were asked to take dynamic electrocardiogram examination before and after observation.

[0173] Inclusion criteria: meet the western medical diagnostic criteria for "ventricular premature beat", including typical symptoms such as palpitations, chest tightness, fatigue, and electrocardiogram or dynamic electrocardiogram suggesting ventricular premature beat; 2 times of Holter examination.

[0174] Exclusion criteria: secondary premature beat caused by severe ion disorder, hyperthyroidism, blood system disease, cardiomyopathy, drug effect, etc.; radiofrequency ablation or electrical cardioversion during the observation period; patients with pacemaker and mechanical valve.

[0175] 2) Intervention measures

[0176] On the basis of the patient's previous conventional treatment, the Chinese medicine composition (oral liquid, i.e. Shenwei Dingji oral liquid, 200ml) prepared in Example 5 of the application was added, and was taken after breakfast and dinner, twice a day.

[0177] 3) Outcome indicators

[0178] Referring to Zhang Xiangyu's "Research on Core Index Set of TCM Treatment of Ventricular Premature Beat", the number of ventricular premature beat within 24 hours indicated by Holter before and after treatment of the patient, and the TCM symptom score were selected as outcome indicators. The calculation method of TCM symptom score table is shown in Table 1.

[0179] Table 1 of TCM syndrome score scale

[0180]

[0181] The observation time point is the first time the patient takes the traditional Chinese medicine treatment and the last time the patient visits the doctor in the observation time range.

[0182] The efficacy index = (initial diagnosis TCM syndrome score - final diagnosis TCM syndrome score) / initial diagnosis TCM syndrome score * 100%, if the efficacy index > 30%, it is considered effective.

[0183] 4) Statistical analysis

[0184] The measurement data conforming to the normal distribution are represented by mean ± standard deviation, and the comparisons between groups are analyzed by t-test or one-way ANOVA; the measurement data not conforming to the normal distribution are represented by median and interquartile range [M (Q1, Q3)], and the comparisons between groups are analyzed by Wilcoxon rank-sum test. P < 0.05 is considered statistically significant.

[0185] 5) Efficacy and safety evaluation

[0186] A total of 27 patients were observed. Among them, 22 patients had obvious improvement in TCM symptoms, the efficacy index was ≥ 30%, and were judged to be effective; 5 patients had no obvious improvement in symptoms and were considered ineffective. The total clinical effective rate was 81.5%. The age and disease duration of the patients are described in Table 2, P > 0.05, indicating that the difference is not statistically significant, i.e., there is no significant difference in age and disease duration between the effective and ineffective populations. The efficacy distribution of different genders is shown in Table 3, and the chi-square test χ 2 >0.05 indicates that the difference is not statistically significant, i.e., gender is not a factor affecting efficacy.

[0187] Table 2 Age and disease duration

[0188]

[0189] Table 3 Efficacy distribution of different genders

[0190] Valid Invalid Total Efficiency Male 9 1 10 90％ Female 13 4 17 76％ Total 22 5 27 81％

[0191] Wilcoxon rank-sum test was performed on the number of 24-hour ventricular premature beats and TCM syndrome scores of the patients before and after treatment (results are shown in Table 3), and it was found that P < 0.05, indicating that the difference between the groups is statistically significant, which shows that the treatment of ventricular premature beat by the traditional Chinese medicine composition (Shiwei Dingji Decoction) of the application can effectively improve the number of premature beats and relieve clinical symptoms. The efficacy comparison before and after treatment is shown in Table 4.

[0192] Table 4 Efficacy comparison before and after treatment

[0193]

[0194] No obvious adverse reactions such as abdominal distension, diarrhea, nausea, vomiting, dizziness, etc. were observed in the 27 patients, and there were no obvious abnormalities in liver and kidney indicators. No obvious clinical adverse reactions and side effects of Shenwei Dingji Decoction have been found.

[0195] Individual efficacy observation of Shenwei Dingji Decoction in test example 2

[0196] Patient, female, 61 years old, complained of palpitation for 2 months.

[0197] Initial diagnosis (February 11, 2018): 2 months ago, the patient had palpitations due to severe anxiety and depression. On January 17, 2018, Holter examination showed: maximum heart rate 121 bpm, minimum heart rate 52 bpm, average heart rate 77 bpm, total heart rate 107651, including 10133 premature ventricular contractions and 33 supraventricular premature beats. The patient had a history of anxiety, depression, and sleep disorders, and was currently taking anti-depression and sleep medication. At the moment, the patient complained of palpitations, which were more obvious in the morning, no obvious fatigue and weakness, poor sleep, dark red tongue, yellow tongue fur, moderate stasis in sublingual collateral vessels, and wiry pulse. The patient was diagnosed with palpitations, deficiency of both qi and yin, and blood stasis, and was treated with tonifying qi and yin, promoting blood circulation and calming palpitations.

[0198] Prescription: Taizishen 15g, Wuweizi 10g, Yansu 15g, Yujin 15g, Yuanzhi 10g, Lianxixin 5g, Hehuanpi 15g, Huansuanzhi 20g, Gansong 12g, Yincha 12g, Qinghao 12g. Decoction to 200ml, one dose a day, taken after breakfast and dinner.

[0199] Second diagnosis (April 8, 2018): On April 2, 2018, Holter reexamination showed: minimum heart rate 49 bpm, maximum heart rate 113 bpm, average heart rate 67 bpm, total heart rate 93005, 3223 premature ventricular contractions, 49 pairs of double rhythm, 116 pairs of triple rhythm, and 38 supraventricular premature beats. At the moment, the patient complained of no obvious fatigue and weakness, poor sleep, difficulty falling asleep, yellow tongue fur, dark red tongue, and wiry pulse.

[0200] Prescription: Taizishen 15g, Wuweizi 10g, Yansu 15g, Yujin 15g, Yuanzhi 10g, Lianxixin 5g, Hehuanpi 15g, Huansuanzhi 20g, Gansong 12g, Yincha 12g, Qinghao 12g, Suanzaoren 15g, Tufuling 15g. Decoction to 200ml, one dose a day, taken after breakfast and dinner.

[0201] On the basis of this prescription, the patient's fatigue, poor sleep, and sighing were improved, and the condition was stable.

[0202] The patient in the test example 2 was treated due to palpitation. According to the relevant symptoms, signs and auxiliary examination, the patient was diagnosed as ventricular premature beat in western medicine, and was diagnosed as deficiency of both qi and yin and blood stasis in TCM. After 2 months of treatment with the Shenwei Dingji Decoction, the Holter reexamination of the patient showed that the number of ventricular premature beat in 24 hours was reduced from 10133 times to 3223 times, and the palpitation symptoms and anxiety of the patient were obviously relieved. It is indicated that the Shenwei Dingji Decoction can effectively reduce the number of ventricular premature beat and relieve the clinical symptoms, and is especially suitable for deficiency of both qi and yin and blood stasis.

[0203] The above embodiments of the present application are only exemplary and do not constitute any limitation on the scope of the present application. Those skilled in the art should understand that the details and forms of the technical solutions of the present application can be modified or replaced without departing from the spirit and scope of the present application, and these modifications and replacements all fall within the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating ventricular premature beat, characterized in that it is composed of The raw materials are prepared as follows: Radix Pseudoginseng, Schisandra chinensis, Rhizoma Corydalis, Radix Anemarrhenae, Polygala, Lotus Plumule, Albizia, Cornus, Herba Nardostachyos, Radix Stellariae, Artemisia.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The raw materials are preferably prepared in the following proportions by weight: Radix Pseudoginseng 12-15, Schisandra chinensis 5-10, Rhizoma Corydalis 12-15, Radix Anemarrhenae 12-15, Polygala 5-10, Lotus Plumule 5-10, Albizia 15-20, Cornus 15-20, Herba Nardostachyos 12-15, Radix Stellariae 10-12, Artemisia 10-12.

3. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition is a traditional Chinese medicine extract. The raw materials are preferably prepared in the following proportions by weight: Radix Pseudoginseng 12, Schisandra chinensis 10, Rhizoma Corydalis 15, Radix Anemarrhenae 15, Polygala 10, Lotus Plumule 10, Albizia 15, Cornus 15, Herba Nardostachyos 12, Radix Stellariae 12, Artemisia 10.

4. Use of the traditional Chinese medicine composition of any one of claims 1-3 in the preparation of a drug for treating or preventing a premature ventricular contraction condition.

5. The use according to claim 4, wherein the compound is ###0002### The premature ventricular contraction is of the type of deficiency of both qi and yin and blood stasis.

6. A method for preparing a traditional Chinese medicine composition for treating ventricular premature beat, characterized in that, The method comprises the following steps: 1) Raw medicinal materials are prepared in the following proportions by weight: Radix Pseudoginseng 10-20, Schisandra chinensis 1-15, Rhizoma Corydalis 5-25, Radix Anemarrhenae 7-20, Polygala 1-15, Lotus Plumule 1-20, Albizia 10-25, Cornus 10-25, Herba Nardostachyos 10-20, Radix Stellariae 5-15, Artemisia 5-15; 2) The raw medicinal material Cornus is added to water, which is heated to boiling to perform a first decocting treatment of Cornus, obtaining a first decocting mixture of Cornus; 3) The raw medicinal materials Radix Pseudoginseng, Schisandra chinensis, Rhizoma Corydalis, Radix Anemarrhenae, Polygala, Lotus Plumule, Albizia, Herba Nardostachyos, and Radix Stellariae are mixed with water, and then added to the first decocting mixture of Cornus obtained in step 2), and heated to perform an extraction treatment, and then filtered to obtain a first extraction liquid and a first residue; 4) The first residue is added with water at least once, and the heating extraction treatment is continued for at least once, and then filtered, and the filtered liquid is mixed with the first extraction liquid to obtain a mixed medicinal material extraction liquid; 5) Artemisia is added to the mixed medicinal material extraction liquid, and then heated to perform an extraction treatment, and then filtered to obtain an extracted liquid; 6) The extracted liquid obtained in step 5) is concentrated to obtain an active component.

7. The production method according to claim 6, wherein The raw materials are preferably prepared in the following proportions by weight in step 1): Radix Pseudoginseng 12-15, Schisandra chinensis 5-10, Rhizoma Corydalis 12-15, Radix Anemarrhenae 12-15, Polygala 5-10, Lotus Plumule 5-10, Albizia 15-20, Cornus 15-20, Herba Nardostachyos 12-15, Radix Stellariae 10-12, Artemisia 10-12.

8. The production method according to claim 6, wherein The relative density of the mixed concentrated liquid after the concentration treatment is 1.05-1.

3.

9. The production method according to claim 6, wherein The relative density of the mixed concentrated liquid after the concentration treatment is 1.1-1.

3.

10. The production method according to claim 6, wherein The relative density of the mixed concentrated liquid after the concentration treatment is 1.1-1.2.

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