Traditional Chinese medicine composition for treating ventricular premature beat as well as preparation method and application thereof

Abstract

The invention 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, corydalis tuber, radix curcumae, polygala tenuifolia, lotus plumule, cortex albiziae, calcined concha arcae, rhizoma nardostachyos, radices stellariae dichotomae and artemisia apiacea. 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 care product, has the effects of reinforcing qi and nourishing yin, regulating qi and activating blood, and soothing the nerves and calming palpitation, can effectively improve the symptoms of patients and remarkably reduce the premature beat frequency, and is particularly suitable for being applied to ventricular premature beat caused by deficiency of both qi and yin and blood stasis.

Description

Technical Field

[0001] The invention relates to a Chinese medicine composition and a preparation method thereof, in particular to a Chinese medicine composition for premature ventricular beats and a preparation method thereof, belonging to the field of traditional Chinese medicine. Background Art

[0002] Premature ventricular contractions, also known as premature ventricular contractions (PVCs), are ventricular excitations that occur prematurely due to ectopic pacemakers below the branches of the His bundle. They are more common in middle-aged and elderly people.

[0003] Ventricular premature beats can be seen in normal people, and can be caused by mental stress, excessive fatigue, etc. Ventricular premature beats are more common in patients with hypertension, coronary heart disease, acute myocardial infarction, cardiomyopathy, myocarditis, mitral valve prolapse, digitalis or quinidine poisoning, hypokalemia, etc.

[0004] Generally, occasional ventricular premature beats do not cause any discomfort. When ventricular premature beats occur frequently or continuously, cardiac output and perfusion of important organs may decrease, resulting in symptoms such as palpitations, chest tightness, fatigue, dizziness, sweating, angina pectoris or dyspnea. Auscultation can hear a sudden premature heartbeat, with the first heart sound louder than normal, the second heart sound weak or inaudible, and a long compensatory interval afterwards. Pulse diagnosis can feel a weak pulse that appears prematurely, followed by a long compensatory interval. Ventricular premature beats can be seen in patients with organic heart disease, as well as in normal people without organic heart disease. When ventricular premature beats are found, a 24-hour dynamic electrocardiogram (Holter) should generally be performed, and a quantitative and qualitative analysis of the ventricular premature beats should be performed to evaluate and guide prognosis.

[0005] At present, the main intervention methods for ventricular premature beats include drug therapy, electrical cardioversion and catheter ablation. The main function of drugs is to inhibit the outflow of sodium and potassium ions, block β1 receptors and calcium ions (Ca 2+ ) channels, inhibiting the generation of action potentials and slowing their conduction. Commonly used drugs include metoprolol, mexiletine, amiodarone, propafenone, verapamil, etc. For patients with normal cardiac structure and function, beta-blockers such as metoprolol or Ca2+ can be used first. 2+ Channel blockers, such as verapamil. Catheter ablation can be recommended for patients with RVOT origin, frequent symptoms, and ineffective or inappropriate drug treatment; catheter ablation is also recommended for induced cardiomyopathy. If the lesion is deep and standard ablation techniques cannot penetrate, infusion needle ablation with a deflectable catheter can also be considered. However, there is still a recurrence rate of about 18% within 3 years after radiofrequency ablation.

[0006] Western medicine generally recommends electrical cardioversion or radiofrequency ablation for patients with heavy ventricular premature beats or high risk. However, for patients with multiple recurrences, there is still a lack of better methods and means except multiple radiofrequency ablation, increased drug dosage, and combination of multiple drugs. For asymptomatic low-risk patients with a percentage of ventricular premature beats to the total heart rate, that is, a ventricular premature beat load of less than 10%, they have not yet reached the standard for the use of Western medicine and can only continue to observe and wait for the disease to progress.

[0007] The Chinese patent medicines recommended by the "Guidelines for the Clinical Application of Chinese Patent Medicines in the Treatment of Ventricular Premature Beats (2020)" for the treatment of ventricular premature beats of qi and yin deficiency type mainly include Wenxin Granules, Shensong Yangxin Capsules, Tongmai Yangxin Pills, etc. Among them, Wenxin Granules are mainly composed of Codonopsis pilosula, Polygonatum sibiricum, Panax notoginseng, Amber, Nardostachys grandiflora, etc., which are suitable for ventricular premature beats of qi and yin deficiency type, while the Chinese medicine composition of the present invention is suitable for ventricular premature beats of qi and yin deficiency and blood stasis type. Shensong Yangxin Capsule is based on Shengmai Powder, and is suitable for ventricular premature beats of coronary heart disease belonging to qi and yin deficiency and heart meridian stasis syndrome. Drugs such as Coptis chinensis for clearing heat and dampness, Salvia miltiorrhiza for promoting blood circulation, and Eupolyphaga sinensis for breaking blood are added. The Chinese medicine combination of the present invention is more suitable for mild symptoms of ventricular premature beats and is used when it is not combined with other organic heart diseases.

[0008] The Chinese medicine formula for treating ventricular premature beats of the present invention is derived from an in-depth study of the prescriptions of traditional Chinese medical masters, can effectively relieve palpitations, reduce the number of ventricular premature beats, and achieve the effect of preventing diseases before they occur, thereby preventing or slowing down the progression of the disease. Summary of the invention

[0009] The primary purpose of the present invention is to provide a Chinese medicine composition for treating ventricular premature beats and a preparation method thereof for the existing technical problems in treating qi and yin deficiency and blood stasis type ventricular premature beats. The standardization and normalization of current Chinese patent medicines, the accuracy of syndrome differentiation and treatment, the interaction of drugs, sufficient clinical research evidence, suitable dosage forms and administration methods, clear indications and contraindications, and other technical problems all need to be further optimized and improved. The Chinese medicine composition of the present invention is directed to ventricular premature beats, especially the etiology of qi and yin deficiency and blood stasis type ventricular premature beats, and adopts a variety of Chinese medicines to cooperate with each other, and the mutual synergistic synergy of its active ingredients significantly improves the clinical symptoms of ventricular premature beats, and effectively improves the pathological state of qi and yin deficiency and blood stasis, replenishes qi and nourishes yin, activates blood circulation and dredges collaterals, and calms the nerves and palpitations. The composition of the present invention has a high curative effect on the treatment of ventricular premature beats, the number of premature beats is significantly reduced, the clinical symptoms are effectively improved, the progression of the disease and the generation of complications are delayed, and no toxic and side effects have been found in clinical use.

[0010] To achieve the purpose of the present invention, on the one hand, the present invention provides a traditional Chinese medicine composition for treating ventricular premature beats, comprising the following raw materials: Pseudostellaria baicalensis, Schisandra chinensis, Corydalis yanhusuo, Curcuma aromatica, Polygala tenuifolia, Lotus seed core, Albizzia julibrissin, Semen cordata, Nardostachys grandiflora, Bupleurum chinense, and Artemisia

[0011] Among them, the weight ratio of the raw materials is: 10-20 of Pseudostellariae Radix, 1-15 of Schisandrae Chinensis Fruit, 5-25 of Corydalis Root, 7-20 of Curcuma Radix, 1-15 of Polygala Tenuifolia, 1-20 of Nelumbinis Pellets, 10-25 of Albizzia Julibrissin Bark, 10-25 of Cortex Cortex Corticatae, 10-20 of Nardostachys grandiflora, 5-15 of Bupleurum Root, and 5-15 of Artemisia Annua.

[0012] In particular, the weight ratio of the raw materials is preferably: 12-15 Pseudostellariae Radix, 5-10 Schisandrae Chinensis Fruit, 12-15 Corydalis Root, 12-15 Curcuma Radix, 5-10 Polygala Tenuifolia, 5-10 Nelumbinis Pellets, 15-20 Albizzia Julibrissin Bark, 15-20 Cortex Corticatae, 12-15 Nardostachys grandiflora, 10-12 Bupleurum Root, and 10-12 Artemisia Annua.

[0013] In particular, the weight ratio of the raw materials is preferably: 12 parts of Pseudostellariae Radix, 10 parts of Schisandrae Chinensis Fruit, 15 parts of Corydalis yanhusuo, 15 parts of Curcuma Radix, 10 parts of Polygala Tenuifolia, 10 parts of Nelumbinis Pulse, 15 parts of Albizzia Julibrissin, 15 parts of Cortex Cortex Corticatae, 12 parts of Nardostachys grandiflora, 12 parts of Bupleurum chinense, and 10 parts of Artemisia annua.

[0014] In particular, the ventricular premature beats are preferably ventricular premature beats of the Qi and Yin deficiency and blood stasis type, wherein the Qi and Yin deficiency syndrome is characterized by shortness of breath, fatigue, spontaneous sweating, laziness to speak, and aggravation of Qi deficiency syndrome with movement, and Yin deficiency syndrome with fever in the five parts of the body, dry mouth and throat, hot flashes and night sweats, red cheeks, dry stool, dry skin, red tongue with little coating, and thin pulse; the blood stasis syndrome is characterized by clinical manifestations such as purple tongue or ecchymosis, purple or dark lips, tingling, colic, numbness or hemiplegia of limbs, rough skin and nails, sluggish or intermittent pulse or no pulse.

[0015] In particular, the clinical manifestations of the ventricular premature beats are palpitations, chest tightness, rapid heart rate, and tachyarrhythmia; the most common clinical tachyarrhythmia is palpitations and chest tightness as the main manifestations.

[0016] In particular, the ventricular premature beats refer to electrocardiograms or dynamic electrocardiograms that, combined with the patient's symptoms and signs, meet the diagnostic criteria for ventricular premature beats.

[0017] The diagnosis of ventricular premature beats is mainly based on clinical symptoms and electrocardiograms. The clinical manifestations of ventricular premature beats are mainly palpitations, panic, chest tightness, fatigue, shortness of breath, dizziness, blackouts, etc. Mild ventricular premature beats may also have no obvious clinical manifestations. Electrocardiogram or dynamic electrocardiogram indicates the presence of ventricular premature beats. During physical examination, cardiac auscultation can reveal that the intensity of the second heart sound is weakened, the radial artery pulsation is weakened or disappeared, and normal or huge a waves can be seen in the jugular vein. The ECG manifestations are: premature, wide and deformed QRS waves, generally greater than 0.12 seconds; the direction of the ST segment and T wave is opposite to the direction of the main QRS wave; the interval between the sinus beat and the subsequent PVCs is constant.

[0018] In particular, the ventricular premature beats of the Qi and Yin deficiency type are characterized by shortness of breath, fatigue, spontaneous sweating, laziness to speak, and aggravation of Qi deficiency symptoms such as movement, and Yin deficiency symptoms such as fever in the five parts of the body, dry mouth and throat, hot flashes and night sweats, red cheeks, dry stools, dry skin, red tongue with little coating, and a thin and rapid pulse.

[0019] Blood stasis syndrome is defined as meeting one of the following major criteria or two of the following minor criteria:

[0020] Main criteria: dark purple tongue or ecchymoses; cyanosis or dark color on the face, lips, gums, eye area and fingertips; varicose veins or abnormal dilation of capillaries in different parts of the body (such as sublingual, conjunctiva, fundus, oral mucosa, abdominal wall, lower limbs, digestive tract, etc.); exanthemeral blood (blood stasis and accumulation in organs, tissues, subcutaneous tissue or serosal cavity caused by bleeding); intermittent claudication; abdominal tenderness and resistance; amenorrhea or dark menstrual blood with clots; imaging showing vascular occlusion or moderate to severe stenosis (≥50%), except for those who do not meet this condition after interventional treatment or surgery), thrombosis, infarction or embolism, or objective evidence of organ ischemia.

[0021] Secondary criteria: fixed pain, or tingling, colic, or pain that is worse at night; numbness of limbs or hemiplegia; dysmenorrhea; skin and nail hyperplasia (rough, thickened skin, increased scaling); mental mania or forgetfulness; sluggish or intermittent pulse, or no pulse; organomegaly, neoplasms, inflammatory or non-inflammatory masses, tissue hyperplasia; imaging and other examinations showing vascular stenosis (<50%); abnormal physical and chemical tests such as blood rheology, coagulation, fibrinolysis, and microcirculation, indicating blood circulation stasis; trauma, surgery, or artificial abortion in the past month.

[0022] In particular, the ventricular premature beats are ventricular premature beats of the Qi and Yin deficiency and blood stasis type.

[0023] In particular, the corrugated seeds are calcined corrugated seeds medicinal pieces; the raw materials Pseudostellaria baicalensis, Schisandra chinensis, Corydalis yanhusuo, Curcuma aromatica, Polygala tenuifolia, Lotus seed core, Albizzia julibrissin, Nardostachys grandiflora, and Bupleurum chinense are respectively processed through the processes of material selection, cleaning, cutting, drying, processing, and crushing to make corresponding Chinese medicinal pieces.

[0024] Particularly, the Corydalis yanhusuo is vinegar Corydalis yanhusuo; the corrugated seeds are calcined corrugated seeds; and the Polygala tenuifolia is processed Polygala tenuifolia, preferably processed Polygala tenuifolia with licorice.

[0025] Corydalis yanhusuo prepared with vinegar can enhance the effect of calming palpitations and relieving pain; raw corydalis yanhusuo can disperse blood stasis and eliminate phlegm, and calcined corydalis yanhusuo can reduce acid and relieve pain. It is mainly used to inhibit excessive gastric acid secretion and neutralize the sour taste of drugs such as Schisandra chinensis; processed polygala tenuifolia, especially those prepared with licorice, can reduce toxicity and enhance efficacy.

[0026] Traditional Chinese medicine researchers have actively explored and studied the treatment of ventricular premature beats and the relief of symptoms, mainly focusing on invigorating qi, nourishing yin, and promoting blood circulation. In terms of drugs, ginseng, ophiopogon japonicus, and schisandra chinensis are the mainstream. However, in clinical treatment, the inventors found that qi and yin deficiency and blood stasis often coexist, accompanied by meridian blockage, etc., which are prone to other complications, and sleep and emotions are common factors affecting the symptoms of ventricular premature beats and palpitations.

[0027] The present invention takes "tonifying qi and nourishing yin, activating blood circulation and regulating qi, calming the nerves and relieving palpitations" as the treatment idea, and formulates the prescription based on the treatment principle of treating both the symptoms and the root causes, and is named "Shenwei Dingji Prescription", wherein Pseudostellaria pseudoginseng invigorates qi and Schisandra chinensis nourishes yin, and together support the body's positive qi; Corydalis yanhusuo and Curcuma aromatica regulate qi, activate blood circulation, and relieve pain; Polygala tenuifolia and Lotus seed heart connect the heart and kidney; Albizzia julibrissin bark relieves depression and activates blood circulation, and together play the role of calming the nerves; calcined Cortex oxyphyllae retards acid and relieves pain, and Nardostachys grandiflora regulates qi and invigorates the spleen, and relieves symptoms of spleen and stomach discomfort such as acid reflux, nausea, abdominal distension, and poor appetite; Bupleurum chinense and Artemisia annua can soothe the liver and relieve depression, and relieve emotional anxiety.

[0028] The Radix Pseudostellariae Radix and Fructus Schisandrae Chinensis Fructus in the prescription of the present invention can invigorate Qi and nourish Yin, and can treat the deficiency of the body's health, which is the pathogenesis of palpitations, and are the main drugs. The auxiliary drugs: Rhizoma Corydalis and Radix Curcumae Radix can regulate Qi, promote blood circulation, and relieve pain, relieve blood stasis in the heart vessels, and relieve palpitations and pain; Polygala Tenuifolia and Pyrus Nelumborum can communicate the heart and kidney, and Cortex Albizziae Albizziae can relieve depression and promote blood circulation, and can treat complications such as insomnia caused by palpitations; Radix Bupleuri and Artemisiae Annua can relieve liver depression and relieve anxiety and other complications. The auxiliary drugs: Fructus Corrugae can relieve acid and relieve pain, and is the auxiliary drug; Nardostachys grandiflora can regulate Qi and invigorate the spleen, and is the auxiliary drug. The combination of the two can relieve stomach discomfort such as acid reflux, nausea, abdominal distension, and poor appetite.

[0029] Pseudostellaria heterophylla (Miq.) Pax ex Paxet Hoffm. is a dried root of the Caryophyllaceae plant. It tastes sweet and slightly bitter, is neutral in nature, and enters the spleen and lung meridians. "New Reference to Medicinal Pieces" states that it "tonifies the spleen and lung vital energy, stops sweating and produces body fluid, and calms palpitations." It has the effects of invigorating qi and strengthening the spleen, producing body fluid and moistening the lungs, and can be used for spleen deficiency, fatigue, loss of appetite, weakness after illness, insufficient qi and yin, spontaneous sweating and thirst, and dry cough due to lung dryness. Its main components are cyclic peptides, polysaccharides, etc. Modern pharmacological studies have shown that Pseudostellaria heterophylla has the functions of enhancing immunity, protecting the myocardium, and anti-oxidation.

[0030] Schisandra chinensis is the dried mature fruit of Schisandra chinensis (Turcz.) Baill., a plant of the Magnoliaceae family. It is sour and sweet, warm in nature, and enters the lung, heart, and kidney meridians. It has the effects of astringency, strengthening qi and promoting the production of body fluid, and nourishing the kidney and calming the mind. It can be used for chronic cough, asthma, nocturnal emission, spermatorrhea, enuresis, frequent urination, chronic diarrhea, spontaneous sweating, night sweats, thirst due to loss of body fluid, internal heat and thirst, palpitations and insomnia. Its main components are schisandra alcohol A, lignans, polysaccharides, terpenes, organic acids, and volatile oils. Modern pharmacological studies have shown that Schisandra chinensis has anti-tumor, anti-oxidation, anti-inflammatory and other effects, as well as cardiovascular protective effects such as anti-myocardial inflammation, anti-oxidative damage, inhibition of myocardial cell apoptosis, and relief of myocardial fibrosis.

[0031] Corydalis yanhusuo, also known as Yuanhu, is the dried tuber of Corydalis yanhusuo WTW of the poppy family. It tastes pungent and bitter, is warm in nature, and enters the liver and spleen meridians. The Compendium of Materia Medica says that it "activates blood circulation, promotes qi, relieves pain, and promotes urination", and the Leigong Paozhi Lun says that it can "cure heartache and death". It has the effects of activating blood circulation, promoting qi, and relieving pain, and can be used for chest and flank pain, abdominal pain, chest pain, amenorrhea, dysmenorrhea, postpartum blood stasis, and swelling and pain caused by falls. Its main component is corydalis ethylene. Modern pharmacological studies have shown that Corydalis yanhusuo has analgesic, sedative and hypnotic, antitussive, anti-addiction, anti-anxiety and anti-depression, neuroprotective and anti-epileptic effects, as well as improving blood rheology, promoting blood circulation, vasodilation, anti-atherosclerosis, anti-myocardial ischemia and reperfusion injury, anti-arrhythmia, lowering blood pressure, myocardial protection, and anti-thrombosis and other cardiovascular protective effects.

[0032] Curcuma wenyujin YHChen et C.Ling, Curcuma Longa L., Curcuma kwangsiensis SGLee et CFLiang or Curcumaphaeocaulis Val. of the Zingiberaceae family. It is pungent and bitter in taste, cold in nature, and enters the liver, heart, and lung meridians. It has the effects of promoting blood circulation and relieving pain, promoting qi and relieving depression, clearing the heart and cooling blood, and promoting gallbladder and relieving jaundice. It can be used for chest and flank pain, chest obstruction and heart pain, amenorrhea and dysmenorrhea, breast distension and pain, febrile coma, epilepsy, vomiting and bleeding due to blood heat, jaundice and red urine. Its main components are sesquiterpenes, monoterpenes, diterpenes and curcumin. Modern pharmacological studies have shown that Curcuma has anti-tumor, anti-inflammatory, antioxidant, antibacterial and antiviral activities, as well as vascular protective effects such as inhibiting platelet aggregation.

[0033] Polygala is the dried root of Polygala tenuifolia Willd. or Polygalasibirica L. of the Polygalaceae family. It tastes bitter and pungent, is warm in nature, and enters the heart, kidney, and lung meridians; it has the effects of calming the mind and improving intelligence, connecting the heart and kidney, removing phlegm, and reducing swelling. It can be used for insomnia, dreaminess, forgetfulness, palpitations, confusion, coughing and expectoration, sores, swelling, and breast pain caused by disharmony between the heart and kidney. Its main components are saponins, ketones, sugar esters, and organic acids. Modern pharmacological studies have shown that Polygala has the effects of removing phlegm, sedation, anticonvulsant, diuresis, antibacterial, inhibiting cAMP phosphodiesterase, anti-mutation, and anti-cancer.

[0034] Albizia Julibrissin is the dried bark of the leguminous plant Albizia julibrissin Durazz. It tastes sweet and is neutral in nature. It is used in the heart, liver and lung meridians. It has the effects of relieving depression and calming the mind, promoting blood circulation and reducing swelling. It can be used for restlessness, depression and insomnia, lung abscess, sores, and pain from falls. Its main components are triterpenes, lignans, flavonoids, sterols, etc. Modern pharmacological studies have shown that Albizia Julibrissin has multiple pharmacological effects such as anti-tumor, antibacterial, anti-anxiety, anti-depression, anti-inflammatory, anti-fertility, immune enhancement and anti-oxidation.

[0035] Lotus seed heart is the dried young leaves and radicles of the mature seeds of the plant Nelumbo nucifera Gaertn. of the Nymphaeaceae family. It tastes bitter, is cold in nature, and enters the heart and kidney meridians. It has the effects of clearing the heart and calming the mind, connecting the heart and kidney, and stopping bleeding. It can be used for heat entering the pericardium, coma and delirium, heart and kidney disharmony, insomnia and spermatorrhea, and blood heat and vomiting blood. Its main active ingredients are alkaloids and flavonoids, including neferine, higenamine, nuciferine, quaternary ammonium base of lotus heart, total alkaloids, schaffroside, rutin, hyperoside, total flavonoids, etc. Modern pharmacological studies have shown that lotus seed heart has anti-cancer, blood pressure lowering, anti-arrhythmia, anti-oxidation and free radical scavenging, anti-fibrosis, anti-metabolic syndrome, neuroprotection and anti-inflammatory effects.

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

[0037] Artemisia annua L. is the dried aerial part of Artemisia annua L., a plant of the Asteraceae family. It tastes bitter and pungent, is cold in nature, and enters the liver and gallbladder meridians. It has the effects of clearing away heat from the deficiency, removing bone steaming, relieving summer heat, stopping malaria, and relieving jaundice. It can be used for treating yin damage caused by warm evil, night heat and morning coolness, fever caused by yin deficiency, bone steaming and fatigue fever, fever caused by summer heat, malaria cold and heat, and damp-heat jaundice. Its main components are sesquiterpenes, coumarins, alkaloids, and lignans. Modern pharmacological studies have shown that Artemisia annua has anti-inflammatory, antibacterial, antiparasitic, antiviral, antitumor, and hypoglycemic effects.

[0038] Corrugated shells are the shells of Arca subcrenata Lischke, Arca granosa Linnaeus or Arca inflata Reeve, all of which are members of the family Corydalis. They are salty in taste, neutral in nature, and enter the lung, stomach, and liver meridians. They have the effects of eliminating phlegm and removing blood stasis, softening and dispersing lumps, and relieving acid and pain. They can be used for stubborn phlegm, which is difficult to cough up, goiter, scrofula, lumps, and stomachache and pantothenia. Their main component is calcium carbonate. Modern pharmacological studies have shown that corrugated shells and their active ingredients have the effects of neutralizing gastric acid to protect the gastric mucosa, anti-tumor, regulating immunity, and lowering blood pressure.

[0039] Nardostachys jatamansi DC. is a plant of the family Patrinaceae. It is pungent and sweet, warm in nature, and enters the spleen and stomach meridians. The Kaibao Materia Medica states that it "treats bad qi, sudden heart and stomach pain". It has the effects of regulating qi and relieving pain, relieving depression and invigorating the spleen. It can be used externally to remove dampness and reduce swelling. It can be used for abdominal distension, loss of appetite, and vomiting; it can also be used externally to treat toothache and beriberi swelling. Its main components are sesquiterpenes, pentacyclic triterpenes, iridoids, flavonoids, lignans, and coumarins. Modern pharmacological studies have shown that Nardostachys jatamansi has the effects of regulating nerves, anti-inflammatory, antibacterial, antioxidant, regulating metabolism, anti-depression, anti-arrhythmic, sedative, and anti-inflammatory.

[0040] Another aspect of the present invention provides an application of the above-mentioned Chinese medicine composition in the preparation of a medicine for treating or preventing ventricular premature beats (ie, premature ventricular contractions).

[0041] Wherein, the ventricular premature beats are ventricular premature beats of qi and yin deficiency type, and ventricular premature beats of qi and yin deficiency combined with blood stasis type.

[0042] Another aspect of the present invention provides a method for preparing a Chinese medicine composition for treating premature ventricular beats, comprising the following steps:

[0043] 1) Prepare the API according to the following weight ratio:

[0044] Radix Pseudostellariae 10-20, Fructus Schisandrae Chinensis 1-15, Rhizoma Corydalis 5-25, Radix Curcumae 7-20, Radix Polygalae 1-15, Pyrus Nelumbinis 1-20, Cortex Albizziae 10-25, Fructus Corticatae 10-25, Rhizoma Nardostachys 10-20, Radix Bupleuri 5-15, Artemisia Annua 5-15;

[0045] 2) adding the raw material drug corrugated seeds into water, heating to boiling, and decocting the corrugated seeds to obtain a decocted corrugated seeds mixture;

[0046] 3) mixing the raw materials Pseudostellariae Radix, Schisandrae Chinensis Fruit, Corydalis yanhusuo, Curcuma Radix, Polygala Tenuifolia, Lotus Seed Heart, Albizzia Julibrissin Bark, Nardostachys grandiflora, and Bupleurum chinense uniformly, adding the mixture to the decoction of Corrugated Seeds obtained in step 2), adding water to mix, then heating, performing a heat extraction treatment, and then filtering to obtain a first extract and a first medicinal residue;

[0047] 4) adding water to the first medicinal residue at least once, continuing the heating extraction process at least once, and then filtering and mixing the filtrate with the first extract to obtain a mixed medicinal material extract;

[0048] 5) adding Artemisia annua to the mixed medicinal material extract, heating, extracting Artemisia annua, and then filtering to obtain an extract;

[0049] 6) Concentrating the extracted liquid to obtain the active component.

[0050] Among them, the weight ratio of the raw materials in step 1) is: 12-15 of Pseudostellariae Radix, 5-10 of Schisandrae Chinensis Fruit, 12-15 of Corydalis Root, 12-15 of Curcuma Radix, 5-10 of Polygala Tenuifolia, 5-10 of Lotus Seed Heart, 15-20 of Albizzia Julibrissin Bark, 15-20 of Cortex Cortex Cortex, 12-15 of Nardostachys grandiflora, 10-12 of Bupleurum Root, and 10-12 of Artemisia Annua.

[0051] In particular, the weight ratio of the raw materials is preferably: 12 parts of Pseudostellariae Radix, 10 parts of Schisandrae Chinensis Fruit, 15 parts of Corydalis yanhusuo, 15 parts of Curcuma Radix, 10 parts of Polygala Tenuifolia, 10 parts of Nelumbinis Pulse, 15 parts of Albizzia Julibrissin, 15 parts of Cortex Cortex Corticatae, 12 parts of Nardostachys grandiflora, 12 parts of Bupleurum chinense, and 10 parts of Artemisia annua.

[0052] In particular, the ratio of the weight of the water added in step 2) to the weight (dry weight) of the corrugated paper of the raw material medicine (i.e., Chinese herbal medicine slices) is (8-10):1, preferably 9:1.

[0053] Particularly, the temperature of the pre-frying treatment of the corrugated paper is 60-100°C, preferably 90-100°C, and more preferably 100°C; the pre-frying treatment time is 0.5-1h.

[0054] Particularly, the method further comprises adding water and soaking the corrugated paper for 20-90 minutes, and then frying the corrugated paper; the soaking time is preferably 30 minutes.

[0055] In particular, the ratio of the weight of water added in step 3) to the total weight (dry weight) of the mixed raw materials is (5-15):1, preferably (8-12):1, and further preferably (9-10):1, wherein the mixed raw materials are Pseudostellaria baicalensis, Schisandra chinensis, Corydalis yanhusuo, Curcuma aromatica, Polygala tenuifolia, Nelumbo nucifera, Albizzia julibrissin, Nardostachys grandiflora and Bupleurum chinense.

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

[0057] In particular, it also includes adding water and soaking for 20-90 minutes, and then performing the heating extraction process.

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

[0059] A) mixing the Chinese medicinal pieces of Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Pithromellae Nelumbinis, Cortex Albizziae, Rhizoma Nardostachys and Radix Bupleuri, wherein the weight of water added is in a ratio of (8-12):1 to the total weight of the raw materials Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Pithromellae Nelumbinis, Cortex Albizziae, Rhizoma Nardostachys and Radix Bupleuri, soaking for 20-90 min, adding the decocted mixture prepared in step 2), heating for the first heating extraction, wherein the heating extraction temperature is 100±2° C., and the heating extraction time is 1-2.5 h;

[0060] B) filtering the first extraction to obtain a first extract;

[0061] C) adding water to the filtered medicinal residue at least once, and continuing to heat and extract at least once, wherein the weight of the water added each time and the total weight of the raw materials Pseudostellariae Radix, Schisandrae Chinensis Fructus, Corydalis yanhusuo, Curcuma Radix, Polygala Tenuifolia, Pith of Nelumbinis, Cortex Albizziae Julibrissin, Rhizoma Nardostachys and Radix Bupleuri are (8-12):1, the heating and extraction temperature is 100±2° C., the heating and extraction time is 1-2.5 h, filtering, and obtaining a second extract;

[0062] D) Mix the first extract and the second extract to obtain.

[0063] In particular, the ratio of the weight of water added each time in step 4) to the total weight (dry weight) of the mixed raw materials is (8-12):1, preferably (9-10):1, wherein the mixed raw materials are Pseudostellaria baicalensis, Schisandra chinensis, Corydalis yanhusuo, Curcuma aromatica, Polygala tenuifolia, Nelumbo nucifera, Albizzia julibrissin, Nardostachys grandiflora and Bupleurum chinense.

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

[0065] In particular, the temperature of the heating extraction treatment in step 4) is 100±2°C; and the time of each heating extraction is 1 to 2.5 hours.

[0066] In particular, the extraction temperature of Artemisia annua in step 5) is 60-100°C, preferably 90-100°C, and more preferably 100°C; the extraction time of Artemisia annua is 10-15min.

[0067] In particular, the extraction temperature of Artemisia annua in step 5) is 100±2°C, preferably 100°C; the extraction time of Artemisia annua is 10-15min.

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

[0069] In particular, the concentration treatment in step 6) is carried out under reduced pressure.

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

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

[0072] In particular, the concentration treatment refers to concentrating the extract obtained in step 5) by reduced pressure evaporation under vacuum to remove water, wherein the concentration temperature is 70-100°C, preferably 70°C, and the relative pressure during concentration is -0.06 to -0.08MPa, more preferably -0.07MPa.

[0073] In particular, the method also includes drying the active components obtained by the concentration process to prepare dry active components of the composition, and preparing the Chinese medicine composition for treating ventricular premature beats.

[0074] The Chinese medicine composition for ventricular premature beats of qi and yin deficiency and blood stasis type of the present invention can be made into a clinically acceptable oral dosage form with pharmaceutically acceptable adjuvants according to traditional or modern production processes. Such as capsules, tablets, granules, pills, oral liquids, etc. The pharmaceutical adjuvants used should review the relevant requirements of the four parts of the Chinese Pharmacopoeia, such as starch, dextrin, lactose, microcrystalline cellulose, gelatin, sucrose, magnesium stearate, etc. Clinically, long-term medication is needed, and solid preparations are made for convenient storage, convenient for patients to take, and more suitable for market demand. Preferred dosage forms are capsules, granules, tablets, pills, powders, oral liquids, etc.

[0075] The Chinese medicine composition prepared by the method of the present invention is aimed at the etiology of ventricular premature beats (especially ventricular premature beats of qi and yin deficiency and blood stasis type), adopts multiple Chinese medicines to cooperate with each other, and the active ingredients thereof are mutually synergistic, and effectively improve the pathological state of qi and yin deficiency and blood stasis, and replenish qi and nourish yin, promote qi and activate blood circulation, and calm the nerves and relieve palpitations. The composition of the present invention has high efficacy in treating ventricular premature beats, and no toxic side effects are found.

[0076] When the Chinese medicine composition prepared by the present invention is used for ventricular premature beats of qi-yin deficiency and blood stasis type, it is taken orally 2-3 times a day, 100 ml each time. Pregnant women are prohibited from taking it. Spicy food and drinking are prohibited during the medication period. After continuous use for 8-12 weeks, the symptoms of palpitations are alleviated, and the number of ventricular premature beats indicated by Holter is effectively reduced.

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

[0078] 1. The Chinese medicine composition (Shenwei Dingji Fang) of the present invention is aimed at the symptomatic treatment of the causes of ventricular premature beats (especially ventricular premature beats of qi and yin deficiency and blood stasis type). The Chinese medicine composition of the present invention is composed of a variety of Chinese medicine ingredients, and the active ingredients of the medicine can play a synergistic role. The Radix Pseudostellariae and Fructus Schisandrae Chinensis in the prescription of the present invention can nourish qi and nourish yin, which can treat the deficiency of the body's health of the pathogenesis of palpitations; Rhizoma Corydalis and Radix Curcumae are good at regulating qi, promoting blood circulation and relieving pain, which can effectively relieve the stasis of the heart vessels caused by long-term illness, and play the role of stabilizing palpitations and relieving pain; Polygala tenuifolia and Pseudostellariae Lotus Seed Heart communicate the heart and kidney, and Cortex Albizziae Albizziae relieves depression and promotes blood circulation, which can treat complications such as insomnia caused by palpitations; Fructus Corrugae can reduce acid and relieve pain, and Rhizoma Nardostachys grandiflora regulates qi and invigorates the spleen, relieving symptoms of spleen and stomach discomfort such as acid reflux, nausea, abdominal distension, and poor appetite; Radix Bupleuri and Artemisiae Annua can relieve liver and depression, and relieve complications such as anxiety. It is particularly suitable for the clinical syndrome of qi and yin deficiency and blood stasis. Aiming at the causes of ventricular premature beats of Qi and Yin deficiency and blood stasis type, a multi-step comprehensive treatment is adopted, with good treatment effect and no side effects.

[0079] In the Chinese medicine composition of the present invention, Radix Pseudostellariae, Fructus Schisandrae Chinensis and Radix Polygalae have the effects of invigorating qi and nourishing yin, and Rhizoma Corydalis and Radix Curcumae have the effects of promoting blood circulation and calming palpitations. These five herbs in the prescription are mainly aimed at the main symptoms of ventricular premature beats (palpitations).

[0080] 2. The Chinese medicine composition of the present invention has significant therapeutic effect on ventricular premature beats, and because Polygala tenuifolia, Lotus seed core, and Albizzia julibrissin bark can calm the nerves and help sleep, Cortex rotundifolia and Nardostachys grandiflora can relieve symptoms of spleen and stomach discomfort such as acid reflux, nausea, abdominal distension, and poor appetite, and Bupleurum chinense and Artemisia annua can relieve anxiety, the whole prescription is particularly suitable for ventricular premature beats combined with complications such as insomnia and anxiety, and the state of weak spleen and stomach, and can more effectively treat ventricular premature beats, reduce the hospitalization rate of patients, and delay further progression of the disease.

[0081] 3. The Chinese medicine composition for treating ventricular premature beats of both Qi and Yin deficiency and blood stasis type (Shenwei Dingji Recipe) of the present invention is derived from the empirical prescription obtained through long-term exploration and optimization by Researcher Weng Weiliang of Xiyuan Hospital of China Academy of Chinese Medical Sciences. After long-term clinical practice, it was found that the medicine can significantly improve the symptoms of palpitations and reduce the number of ventricular premature beats after taking the medicine. No adverse reactions were found after long-term use, no toxic side effects, and the medication time was extended. The preparation process is simple, the product quality is stable, the effect is obvious, and it is easy to use, filling the gap in the market of Chinese patent medicines for treating ventricular premature beats combined with complications such as insomnia and anxiety.

[0082] 4. The Chinese medicine composition for ventricular premature beats of both qi and yin deficiency and blood stasis type (Shenwei Dingji Recipe) of the present invention achieves the purpose of calming the mind and relieving palpitations by invigorating qi and nourishing yin, promoting blood circulation and unblocking meridians, and pays more attention to the improvement of the syndrome of both qi and yin deficiency and blood stasis, and can effectively prevent diseases and complications such as cardiomyopathy and heart failure caused by ventricular premature beats.

[0083] 5. The preparation method of the Chinese medicine composition (Shenwei Dingji Recipe) for ventricular premature beats of qi and yin deficiency and blood stasis type of the present invention is simple, the process conditions are mild, the cost is low, the expense is low, the treatment cost of ventricular premature beats is reduced, the clinical health and medical costs are saved, and it is suitable for market promotion and application, so that more patients can benefit from it. DETAILED DESCRIPTION

[0084] The present invention will be further described below in conjunction with specific embodiments, and the advantages and features of the present invention will become clearer as the description proceeds. However, these embodiments are exemplary only and do not constitute any limitation to the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.

[0085] The beneficial effects of the drug of the present invention are further described below through test examples, which include clinical trials of the drug of the present invention.

[0086] Example 1 Preparation of Shenwei Dingji Granules

[0087] 1) Prepare the API according to the following weight ratio (unit: × 10 g):

[0088] Corydalis 15, Curcuma 15, Pseudostellaria 12, Schisandra 10, Polygala 10, Lotus seed core 10, Albizzia julibrissin bark 15, Cortex 15, Nardostachys grandiflora 12, Bupleurum chinense 12, Artemisia annua 10.

[0089] The raw materials used in the invention are Chinese medicinal pieces, the Corydalis yanhusuo is vinegar Corydalis yanhusuo, the Corundum rostratum is calcined Corundum rostratum, and the Polygala tenuifolia is processed from liquorice.

[0090] 2) Fry the corrugated paper first

[0091] The calcined corrugated pieces of Chinese herbal medicine are soaked in water, the ratio of the weight of the added water to the weight of the corrugated pieces of Chinese herbal medicine is 9:1 (usually (8-10):1), after soaking for 30 minutes (usually 20-90 minutes), the power of the multifunctional Chinese medicine extraction kettle is turned on to heat, and the corrugated pieces are heated to boiling, and the corrugated pieces are pre-decocted to obtain a corrugated piece pre-decocted mixture, wherein: the corrugated piece pre-decocted temperature is 100°C (usually 100±2°C); the time is 45 minutes (usually 30-60 minutes).

[0092] 3) Heating extraction treatment

[0093] 3A) Mix the Chinese medicinal pieces of Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Curcuma Radix, Radix Polygalae, Pith of Lotus Seed, Cortex Albizziae, Rhizoma Nardostachys, and Radix Bupleuri, and place the mixture in a multifunctional Chinese medicinal extraction kettle, then add Corrugated Fruit to decoct the mixture and mix evenly, and then add water to soak for 30 minutes (usually 20-90 minutes), wherein the ratio of the weight of the added water to the total weight (dry weight) of the medicinal material mixture is 9:1 (usually (8-12):1); the medicinal material mixture is Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Curcuma Radix, Radix Polygalae, Pith of Lotus Seed, Cortex Albizziae, Rhizoma Nardostachys, and Radix Bupleuri;

[0094] 3B) Turning on the power of the multifunctional extraction kettle to heat until boiling, performing a first heating extraction treatment on the medicinal material, 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 performed for 2 hours (usually 1 to 2.5 hours); then filtering to obtain a first extract and a first medicinal residue;

[0095] 3C) adding water to the first medicinal residue, continuing heating, and performing 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 filtering, and mixing the filtrate with the first extract to obtain a mixed medicinal material extract;

[0096] The heating extraction temperature is not limited to 100° C., and other temperatures (such as 60 to 100° C., preferably 90 to 100° C.) are applicable to the present invention.

[0097] 4) Extraction and processing of Artemisia annua

[0098] Adding Chinese medicinal pieces of Artemisia annua to the mixed medicinal material extract, adding water and mixing evenly, wherein the weight ratio of the added water to the weight of the raw material Artemisia annua is 9:1 (usually (0-12):1, preferably (0-9):1), turning on the power of the multifunctional extraction kettle for heating, heating to boiling, and performing Artemisia annua extraction treatment, wherein the Artemisia annua extraction treatment temperature is 100° C. (usually 100±2° C.), maintaining the temperature at 100° C. (usually 100±2° C.), constant temperature extraction for 10 minutes (usually 10-15 minutes), and then filtering to obtain an extraction liquid and a filter residue;

[0099] Water may not be added during the extraction process of Artemisia annua. If a large amount of water is added during the heating extraction process in step 3), water may not be added during the extraction process of Artemisia annua.

[0100] 5) Concentration treatment

[0101] The extracted drug solution is placed in a vacuum high-energy evaporation concentrator and concentrated under reduced pressure to obtain a concentrated solution, wherein the relative pressure of the concentration process is -0.07MPa (i.e., one atmospheric pressure is 0, and the pressure during the reduced pressure concentration is controlled to be -0.07MPa relative to one atmospheric pressure), the concentration temperature is 70°C (usually 50-80°C), and the relative density of the concentrated solution is 1.15 (usually 1.05-1.3);

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

[0103] The present invention adopts the method of reduced pressure evaporation concentration to concentrate the extract. In addition to reduced pressure evaporation concentration, all existing known concentration methods in the art are applicable to the present invention, such as heating and evaporation under normal pressure.

[0104] 6) Drying the concentrated solution at 80-90° C. until the moisture content is 5% (usually less than 5%, preferably 1-4%), then crushing the concentrated solution and passing it through a 100-mesh sieve. The residue under the sieve is the dry extract powder, and the particle size of the dry extract powder is ≤100 mesh;

[0105] 7) Mixing the dry extract powder and auxiliary material dextrin, using ethanol as a binder, granulating, and drying to obtain the Chinese medicine Shenwei Dingji granules for treating ventricular premature beats of the present invention.

[0106] Example 2 Preparation of Shenwei Dingji Pills

[0107] 1) Prepare the API according to the following weight ratio (unit: × 10 g):

[0108] Pseudostellariae Radix 15, Schisandrae Chinensis 5, Corydalis 12, Curcuma Radix 12, Polygala Tenuifolia 5, Lotus Seed Pellets 5, Albizzia Julibrissin Bark 20, Cortex Oleraceae 20, Nardostachys grandiflora 15, Bupleurum chinense 10, Artemisia annua 12.

[0109] 2) Fry the corrugated paper first

[0110] Except that the ratio of the weight of the added water to the weight of the Chinese medicine decoction piece corrugated paper is 8:1; the soaking is 60 minutes; and the corrugated paper is first decocted for 60 minutes, the rest is the same as step 2) "corrugated paper is first decocted" in Example 1;

[0111] 3) Heating extraction treatment

[0112] 3A) Mix the Chinese medicinal pieces of Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Pithromyces Nelumbinis, Cortex Albizziae, Rhizoma Nardostachys, and Radix Bupleuri, and place the mixture in a multifunctional Chinese medicine extraction kettle, then add Corrugated Carrageenan to decoct the mixture and mix evenly, and then add water to soak for 60 minutes (usually 20-90 minutes), wherein the ratio of the weight of the added water to the total weight (dry weight) of the medicinal material mixture is 8:1;

[0113] 3B) Turning on the power of the multifunctional extraction kettle to heat until boiling, performing a first heating extraction treatment on the medicinal material, 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 performed for 2 hours (usually 1 to 2.5 hours); then filtering to obtain a first extract and a first medicinal residue;

[0114] 3C) adding water to the first medicinal residue, continuing heating, and performing 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 filtering, and mixing the filtrate with the first extract to obtain a mixed medicinal material extract;

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

[0116] 4) Extraction and processing of Artemisia annua

[0117] Except that no water was added and the constant temperature extraction time of Artemisia annua was 15 min, the rest was the same as step 4) "Artemisia annua extraction treatment" in Example 1.

[0118] 5) Concentration treatment

[0119] Except that 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 liquid is 1.05, the rest is the same as step 5) "concentration treatment" in Example 1.

[0120] 6) spray drying the concentrated solution to obtain an extract dry paste powder;

[0121] 7) Mix the dry extract powder and the auxiliary material refined honey, stir evenly, place in a pill-making machine to make pills, and then dry to obtain the traditional Chinese medicine Shenwei Dingji concentrated pills for treating ventricular premature beats of the present invention.

[0122] Example 3 Preparation of Shenwei Dingji Tablets

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

[0124] Pseudostellariae Radix 20, Schisandrae Chinensis Fruit 1, Corydalis 5, Curcuma Radix 20, Polygala Tenuifolia 15, Nelumbo Nucifera 1, Albizzia julibrissin Bark 25, Semen Cortex Ophiopogonis 25, Nardostachys grandiflora 10, Bupleurum chinense 5, Artemisia annua 5.

[0125] Corydalis yanhusuo is vinegar-processed Corydalis yanhusuo; Polygala tenuifolia is calcined Polygala tenuifolia; Polygala tenuifolia is processed with licorice.

[0126] 2) Fry the corrugated paper first

[0127] Except that the ratio of the weight of the added water to the weight of the Chinese medicine decoction piece corrugated paper is 10:1; the soaking is 30 minutes; and the corrugated paper is first decocted for 30 minutes, the rest is the same as step 2) "corrugated paper is first decocted" in Example 1;

[0128] 3) Heating extraction treatment

[0129] 3A) Mix the Chinese medicinal pieces of Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Pith of Lotus Seed, Cortex Albizziae, Rhizoma Nardostachys, and Radix Bupleuri, and place the mixture in a multifunctional Chinese medicinal extraction kettle, then add Cortex Pseudostellariae to decoct the mixture and mix it evenly; then add water to soak for 30 minutes (usually 20-90 minutes), wherein the ratio of the weight of the added water to the total weight (dry weight) of the medicinal material mixture is 9:1;

[0130] 3B) Turning on the power of the multifunctional extraction kettle to heat until boiling, performing the first heating extraction treatment on the medicinal material, 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 treatment, and the constant temperature extraction is performed for 2 hours (usually 1 to 2.5 hours); then filtering to obtain the first extract and the first medicinal residue;

[0131] 3C) adding water to the first medicinal residue, continuing heating, and performing 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 filtering, and mixing the filtrate with the first extract to obtain a mixed medicinal material extract;

[0132] The heating extraction temperature is not limited to 100° C., and other temperatures such as 60 to 100° C. (preferably 90 to 100° C.) are also applicable to the present invention.

[0133] 4) Extraction and processing of Artemisia annua

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

[0135] 5) Concentration treatment

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

[0137] 6) drying the concentrated solution at 80-90° C. until the moisture content is 4% (usually less than 5%, preferably 1-4%), then pulverizing the concentrated solution and passing it through a 100-mesh sieve. The sieved product is the dry extract powder of the composition of the present invention, and the particle size of the dry extract powder is ≤100 mesh;

[0138] 7) Mixing the extract powder and auxiliary material dextrin, granulating with ethanol, drying, and tableting with a tablet press to obtain the Chinese medicine Shenwei Dingji tablets for treating ventricular premature beats of the present invention.

[0139] Example 4 Preparation of Shenwei Dingji Capsules

[0140] 1) Prepare the API according to the following weight ratio (unit: × 10g)

[0141] Pseudostellariae Radix 10, Schisandrae Chinensis Fruit 15, Corydalis 25, Curcuma Radix 7, Polygala Tenuifolia 1, Lotus Seed Pellets 20, Albizzia Julibrissin Bark 10, Cortex Ophiopogonis 10, Nardostachys grandiflora 20, Bupleurum chinense 15, Artemisia annua 15.

[0142] Corydalis yanhusuo is vinegar-processed Corydalis yanhusuo; Polygala tenuifolia is calcined Polygala tenuifolia; Polygala tenuifolia is processed with licorice.

[0143] 2) Fry the corrugated paper first

[0144] The same as step 2) of Example 1, "pre-frying the corrugated paper".

[0145] 3) Heating extraction treatment

[0146] 3A) Mix the Chinese medicinal pieces of Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Pith of Lotus Seed, Cortex Albizziae, Rhizoma Nardostachys, and Radix Bupleuri, and place the mixture in a multifunctional Chinese medicine extraction kettle, then add Corrugated Caraway to decoct the mixture and mix evenly, and then add water to soak for 90 minutes (usually 20-90 minutes), wherein the ratio of the weight of the added water to the total weight (dry weight) of the medicinal material mixture is 12:1;

[0147] 3B) Turning on the power of the multifunctional extraction kettle to heat until boiling, performing the first heating extraction treatment on the medicinal material, 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 performed for 1 hour (usually 1 to 2.5 hours); then filtering to obtain the first extract and the first medicinal residue;

[0148] 3C) adding water to the first medicinal residue, continuing heating, and performing a second heating extraction treatment, wherein the ratio of the weight of the added water to the total weight (dry weight) of the medicinal material mixture is 12:1 (usually (8-12):1); the temperature of the second heating extraction treatment is 100°C (usually 100±2°C); the extraction time is 1h (usually 1-2.5h); then filtering, and mixing the filtrate with the first extract to obtain a mixed medicinal material extract.

[0149] 4) Extraction and processing of Artemisia annua

[0150] Adding the Chinese medicinal piece Artemisia annua to the mixed medicinal material extract, without adding water, directly mixing evenly, turning on the power of the multifunctional extraction kettle for heating, heating to boiling, and performing an Artemisia annua extraction process, wherein the Artemisia annua extraction process is performed at a temperature of 100° C. (usually 100±2° C.), maintaining the temperature at 100° C. (usually 100±2° C.), extracting at a constant temperature for 15 minutes (usually 10-15 minutes), and then filtering to obtain an extraction liquid and a filter residue;

[0151] 5) Concentration treatment

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

[0153] 6) drying the concentrated solution at 80-90° C. until the moisture content is 5% (usually less than 5%, preferably 1-4%), then pulverizing the concentrated solution and passing it through a 100-mesh sieve. The sieved product is the dry extract powder of the composition of the present invention, and the particle size of the dry extract powder is ≤100 mesh;

[0154] 7) The dry extract powder and the auxiliary material microcrystalline fiber are mixed, granulated, and filled into gelatin hard capsules to obtain the Chinese medicine Shenwei Dingji capsules for treating ventricular premature beats of the present invention.

[0155] Example 5 Preparation of Shenwei Dingji Oral Liquid

[0156] 1) Prepare the API according to the following weight ratio (unit: × 10 g):

[0157] Pseudostellariae Radix 12, Schisandrae Chinensis Fruit 10, Corydalis 15, Curcuma Radix 15, Polygala Tenuifolia 10, Lotus Seed Pellets 10, Albizzia Julibrissin Bark 15, Cortex Ophiopogonis 15, Nardostachys grandiflora 12, Bupleurum chinense 12, Artemisia annua 10.

[0158] Corydalis yanhusuo is vinegar-processed Corydalis yanhusuo; Polygala tenuifolia is calcined Polygala tenuifolia; Polygala tenuifolia is processed with licorice.

[0159] 2) Fry the corrugated paper first

[0160] Except that the ratio of the weight of the added water to the weight of the Chinese medicine decoction piece corrugated paper is 9:1; the soaking is 30 minutes; and the corrugated paper is first decocted for 60 minutes, the rest is the same as step 2) "the corrugated paper is first decocted" in Example 1;

[0161] 3) Heating extraction treatment

[0162] 3A) Mix the Chinese medicinal pieces of Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Pithromyces Nelumbinis, Cortex Albizziae, Rhizoma Nardostachys, and Radix Bupleuri, and place the mixture in a multifunctional Chinese medicinal extraction kettle, then add Corrugated Bark to decoct the mixture and mix evenly, then add water to soak for 30 minutes (usually 20-90 minutes), wherein the ratio of the weight of the added water to the total weight (dry weight) of the medicinal material mixture is 9:1 (usually (8-12):1);

[0163] 3B) Turn on the power of the multifunctional extraction kettle to heat until boiling, and perform the first heating extraction treatment on the medicinal material, wherein the first heating extraction treatment temperature is 100° C. (usually 100±2° C.), and during the first heating extraction process, the temperature is maintained at 100° C. (usually 100±2° C.), and the constant temperature extraction is performed for 2.5 hours (usually 1 to 2.5 hours); then filter to obtain the first extract and the first medicinal residue;

[0164] 3C) adding water to the first medicinal residue, continuing heating, and performing 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 filtering, and mixing the filtrate with the first extract to obtain a mixed medicinal material extract;

[0165] 4) Extraction and processing of Artemisia annua

[0166] Adding the Chinese medicinal piece Artemisia annua to the mixed medicinal material extract, without adding water, directly mixing evenly, turning on the power of the multifunctional extraction kettle for heating, heating to boiling, and performing an Artemisia annua extraction process, wherein the Artemisia annua extraction process is performed at a temperature of 100° C. (usually 100±2° C.), maintaining the temperature at 100° C. (usually 100±2° C.), extracting at a constant temperature for 15 minutes (usually 10-15 minutes), and then filtering to obtain an extraction liquid and a filter residue;

[0167] 5) Concentration treatment

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

[0169] 6) preparing a liquid from the concentrated liquid, filling it, and sterilizing it to prepare the Chinese medicine Shenwei Dingji oral liquid (Shenwei Dingji Decoction) for treating ventricular premature beats of the present invention.

[0170] Experimental Example 1 Observation on the Clinical Efficacy of Shenwei Dingji Decoction

[0171] 1) Research subjects

[0172] Patients with ventricular premature beats who visited Professor Weng Weiliang's outpatient clinic at Xiyuan Hospital, China Academy of Chinese Medical Sciences from November 12, 2017 to December 31, 2022 and were treated with Shenwei Dingji Decoction were observed, and the patients were asked to undergo dynamic electrocardiogram before and after the observation.

[0173] Inclusion criteria: Patients met the Western medical diagnostic criteria for "ventricular premature beats", including typical symptoms such as palpitations, chest tightness, fatigue, and electrocardiogram or dynamic electrocardiogram indicating ventricular premature beats; 2 Holter examinations were performed.

[0174] Exclusion criteria: secondary premature beats caused by severe ion disorders, hyperthyroidism, blood system diseases, cardiomyopathy, drug effects and other factors; radiofrequency ablation or electrical cardioversion during the observation period; patients with pacemakers and mechanical valves.

[0175] 2) Intervention measures

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

[0177] 3) Outcome indicators

[0178] Referring to Zhang Xiangyu's "Research on the Core Indicators of Traditional Chinese Medicine Treatment of Ventricular Premature Beats", the number of ventricular premature beats within 24 hours indicated by Holter before and after treatment and the TCM symptom score were selected as outcome indicators. The calculation method of the TCM symptom score scale is shown in Table 1.

[0179] Table 1 TCM symptom scoring scale

[0180]

[0181] The observation time points were the first time the patient took Chinese medicine for treatment and the last follow-up visit within the observation period.

[0182] Efficacy index = (initial TCM symptom score - final TCM symptom score) / initial TCM symptom score * 100%. If the efficacy index > 30%, it is considered effective.

[0183] 4) Statistical analysis

[0184] Normally distributed measurement data were expressed as mean ± standard deviation, and inter-group comparisons were performed using t-test or one-way ANOVA. Non-normally distributed measurement data were expressed as median and interquartile range [M(Q1,Q3)], and inter-group comparisons were performed using Wilcoxon rank sum test. P < 0.05 was considered statistically significant.

[0185] 5) Evaluation of efficacy and safety

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

[0187] Table 2 Age and disease duration

[0188]

[0189] Table 3 Distribution of efficacy by gender

[0190] efficient invalid total Efficiency male 9 1 10 90％ female 13 4 17 76％ total 22 5 27 81％

[0191] The Wilcoxon rank sum test was performed on the number of ventricular premature beats and TCM symptom scores of the patients before and after treatment (the results are shown in Table 3), and P < 0.05 was found, indicating that the difference between the groups was statistically significant, indicating that the application of the Chinese medicine composition for treating ventricular premature beats (Shenwei Dingji Recipe) of the present invention can effectively improve the number of premature beats and relieve clinical symptoms. The comparison of the efficacy before and after treatment is shown in Table 4.

[0192] Table 4 Comparison of therapeutic effects before and after treatment

[0193]

[0194] None of the 27 patients observed had obvious adverse reactions, such as abdominal distension, diarrhea, nausea, vomiting, dizziness, etc., and there were no obvious abnormalities in liver and kidney indicators. No obvious clinical adverse reactions and side effects have been found in the Shenwei Dingjin prescription.

[0195] Experimental Example 2 Observation on the Individual Efficacy of Shenwei Dingji Decoction

[0196] A 61-year-old female patient presented with chief complaint of palpitations for 2 months.

[0197] Initial diagnosis (February 11, 2018): Two months ago, the patient suffered from palpitations due to severe anxiety and depression. On January 17, 2018, the Holter examination showed: maximum heart rate 121bpm, minimum heart rate 52bpm, average heart rate 77bpm, total heart beats 107651, including 10133 ventricular premature beats and 33 supraventricular premature beats. The patient had a history of anxiety, depression, and sleep disorders, and is now regularly treated with antidepressants and sleeping pills. Current symptoms: palpitations, obvious in the morning, no obvious fatigue, poor sleep, dark red tongue, yellow tongue coating, moderate stasis of sublingual collaterals, and stringy pulse. Diagnosed with palpitations, qi and yin deficiency and blood stasis, the treatment is to replenish qi and nourish yin, and activate blood circulation to calm palpitations.

[0198] Prescription: Pseudostellariae Radix 15g, Schisandrae Chinensis 10g, Corydalis 15g, Curcuma Radix 15g, Polygala 10g, Lotus Seed Heart 5g, Albizzia Julibrissin Bark 15g, Calcined Corrugated Fructus 20g, Nardostachys grandiflora 12g, Bupleurum chinense 12g, Artemisia annua 12g. Decoction in water until 200ml, one dose per day, after breakfast and dinner.

[0199] Second visit (April 8, 2018): Holter re-examination on April 2, 2018: minimum heart rate 49bpm, maximum heart rate 113bpm, average heart rate 67bpm, total heart rate 93005 beats, 3223 ventricular premature beats, 49 bigeminy, 116 tripeminy, 38 supraventricular premature beats. Current symptoms: no obvious fatigue, poor sleep, difficulty falling asleep, yellow tongue coating, dark red tongue, stringy pulse.

[0200] Prescription: Pseudostellariae Radix 15g, Schisandrae Chinensis 10g, Corydalis 15g, Curcuma Radix 15g, Polygala 10g, Lotus Seed Heart 5g, Albizzia Julibrissin Bark 15g, Calcined Corrugated Seed 20g, Nardostachys grandiflora 12g, Bupleurum 12g, Artemisia annua 12g, Semen Ziziphi Spinosae 15g, Smilax glabra 15g. Decoction in water until 200ml, one dose per day, after breakfast and dinner.

[0201] On the basis of this prescription, the medication was adjusted (adding Chinese jujube seeds and Chinese yam) to target the current concurrent symptoms (fatigue, poor sleep). By the fifth visit, the patient's palpitations were relieved, and his fatigue, sighing, and sleep were all improved compared to before, and his condition was stable.

[0202] The patient in Experimental Example 2 was diagnosed with palpitations. Based on relevant symptoms, signs and auxiliary examinations, the Western medicine diagnosis was ventricular premature beats, and the TCM syndrome differentiation was consistent with the syndrome of qi and yin deficiency and blood stasis. After two months of treatment with Shenwei Dingji Recipe, the patient's Holter reexamination showed that the number of ventricular premature beats within 24 hours dropped from 10133 to 3223, and the patient's palpitations and anxiety were significantly relieved. This shows that Shenwei Dingji Recipe can effectively reduce the number of ventricular premature beats and relieve clinical symptoms, and is particularly suitable for the syndrome of qi and yin deficiency and blood stasis.

[0203] The above embodiments of the present invention are only exemplary and do not constitute any limitation to the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating ventricular premature beats, characterized in that: The invention comprises the following raw materials: Radix Pseudostellariae, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Pyrus Nelumbinis, Cortex Albizziae, Fructus Corticatae, Rhizoma Nardostachys, Radix Bupleuri, and Artemisia Annua.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight proportion of the raw materials is: 10-20 Pseudostellariae Radix, 1-15 Schisandrae Chinensis Fruit, 5-25 Corydalis Root, 7-20 Curcuma Radix, 1-15 Polygala Tenuifolia, 1-20 Lotus Seed Pellets, 10-25 Albizzia Julibrissin Bark, 10-25 Cortex Cortex Corticatae, 10-20 Nardostachys grandiflora, 5-15 Bupleurum Chinense, and 5-15 Artemisia Annua.

3. The Chinese medicine composition according to claim 1, characterized in that: The weight proportion of the raw materials is preferably: 12-15 Pseudostellariae Radix, 5-10 Schisandrae Chinensis Fruit, 12-15 Corydalis Root, 12-15 Curcuma Radix, 5-10 Polygala Tenuifolia, 5-10 Lotus Seed Pellets, 15-20 Albizzia Julibrissin Bark, 15-20 Cortex Cortex Corticatae, 12-15 Nardostachys grandiflora, 10-12 Bupleurum Chinense, and 10-12 Artemisia Annua.

4. The Chinese medicine composition according to claim 1, characterized in that: The weight ratio of the raw materials is preferably: 12 parts of Pseudostellariae Radix, 10 parts of Schisandrae Chinensis Fruit, 15 parts of Corydalis yanhusuo, 15 parts of Curcuma Radix, 10 parts of Polygala Tenuifolia, 10 parts of Lotus Seed Pith, 15 parts of Albizzia Julibrissin Bark, 15 parts of Cortex Cortex Corticatae, 12 parts of Nardostachys grandiflora, 12 parts of Bupleurum chinense, and 10 parts of Artemisia annua.

5. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating or preventing ventricular premature beats.

6. The use according to claim 5, characterized in that: The ventricular premature beats are ventricular premature beats of the Qi and Yin deficiency and blood stasis type.

7. A method for preparing a Chinese medicine composition for treating premature ventricular beats, characterized in that: The steps include: 1) Prepare the API according to the following weight ratio: Radix Pseudostellariae 10-20, Fructus Schisandrae Chinensis 1-15, Rhizoma Corydalis 5-25, Radix Curcumae 7-20, Radix Polygalae 1-15, Pyrus Nelumbinis 1-20, Cortex Albizziae 10-25, Fructus Corticatae 10-25, Rhizoma Nardostachys 10-20, Radix Bupleuri 5-15, Artemisia Annua 5-15; 2) adding the raw material drug corrugated seeds into water, heating to boiling, and decocting the corrugated seeds to obtain a decocted corrugated seeds mixture; 3) mixing raw materials such as Radix Pseudostellariae Radix, Fructus Schisandrae Chinensis, Rhizoma Corydalis, Radix Curcumae, Radix Polygalae, Pith of Lotus Seed, Cortex Albizziae Julibrissin, Rhizoma Nardostachys, Radix Bupleuri with water, and then adding the mixture to the decoction of Corrugated Seeds obtained in step 2), and then performing a heating extraction treatment, and then filtering to obtain a first extract and a first medicinal residue; 4) adding water to the first medicinal residue at least once, continuing the heating extraction process at least once, filtering, and then mixing the filtrate with the first extract to obtain a mixed medicinal material extract; 5) adding Artemisia annua to the mixed medicinal material extract, followed by heating to extract Artemisia annua, and then filtering to obtain an extract; 6) The extracted liquid obtained in step 5) is concentrated to obtain the active component.

8. The preparation method according to claim 7, characterized in that: The weight ratio of the raw materials in step 1) is preferably: 12-15 Pseudostellariae Radix, 5-10 Schisandrae Chinensis Fruit, 12-15 Corydalis Root, 12-15 Curcuma Radix, 5-10 Polygala Tenuifolia, 5-10 Lotus Seed Heart, 15-20 Albizzia Julibrissin Bark, 15-20 Cortex Cortex Corticatae, 12-15 Nardostachys grandiflora, 10-12 Bupleurum Root, and 10-12 Artemisia Annua.

9. The preparation method according to claim 7, characterized in that: The relative density of the concentrated mixed liquid after the concentration treatment is 1.05-1.3, preferably 1.1-1.3, and more preferably 1.1-1.2.

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