TW202308675A - Traditional chinese medicine composition, and preparation method therefor and use thereof - Google Patents

Abstract

Disclosed are a traditional Chinese medicine composition, and a preparation method therefor and the use thereof. The traditional Chinese medicine composition comprises the following bulk drugs in parts by weight: 5-35 parts of Bupleuri radix, 5-30 parts of Aurantii fructus immaturus, 5-20 parts of raw Rhei radix et rhizoma, 1-20 parts of Scutellariae radix, 3-20 parts of Paeoniae radix alba, 3-20 parts of Zingiberis rhizoma, 3-25 parts of Hirudo, 3-20 parts of Glycyrrhizae radix et rhizoma, 3-20 parts of Codonopsis radix, 3-20 parts of Atractylodis macrocephalae rhizoma, and 3-45 parts of raw Ostreae concha. The traditional Chinese medicine composition has good effects of preventing or treating atherosclerotic plaque formation, ischemic heart-brain disease, blood fat increase, and triglyceride increase.

Description

Traditional Chinese medicine composition and its preparation method and application

The invention belongs to the field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition and a preparation method thereof, and the preparation of the traditional Chinese medicine composition for preventing or treating atherosclerotic plaque formation, ischemic heart disease, elevated blood lipids, and elevated triglycerides application in medicines.

Atherosclerosis (AS) is the main cause of coronary heart disease, myocardial infarction, cerebral infarction, ischemic heart disease and peripheral vascular disease. The formation mechanism of atherosclerotic plaque is complex and involves many factors, including lipid metabolism disorder, damage to cardiac smooth muscle, collagen fiber proliferation, inflammatory factor accumulation and so on. Plaque formation and sclerosis is thus a multi-mechanism, result of long-term lesion development. Existing data show that the formation of atherosclerotic plaque begins with the injury of the arterial intima, usually with the accumulation of lipids and complex sugars, bleeding, and then fibrous tissue hyperplasia and deposition, and the gradual degeneration and calcification of the arterial media, resulting in thickening of the arterial wall Hardening, stenosis of blood vessels. The main components of carotid atherosclerotic plaques are: (1) dense connective tissue fibrous cap, mainly composed of extracellular matrix (ECM), especially collagen fibers; (2) lipid core, composed of lipid macrophages, smooth muscle cells and ECM composition; (3) Adventitia and neovascularization in plaque. Its characteristic is that the involved lesions often involve large and medium muscular arteries, and once they develop enough to block the arterial lumen, the tissues or organs supplied by the arteries will be ischemic or necrotic. Atherosclerotic plaques are called atherosclerotic plaques because of the yellow porridge-like appearance of lipids that accumulate in the inner lining of arteries.

The Ministry of Health's "2016 China Health Statistical Summary" shows that about 30% of the causes of death in China are due to cardiovascular and cerebrovascular diseases, and the vast majority of these patients with cardiovascular and cerebrovascular diseases die from the formation of atherosclerotic plaques. Cardiovascular disease. The China Cardiovascular Health and Disease Report Writing Group reported in the China Circulation Magazine "China Cardiovascular Health and Disease Report 2019 Summary" that the prevalence of cardiovascular disease in China is in a continuous rising stage. It is estimated that the number of patients with cardiovascular diseases is 330 million, and for every 5 deaths, 2 cases will die from cardiovascular and cerebrovascular diseases. Atherosclerotic cardiovascular and cerebrovascular diseases are therefore known as the "number one killer" of human beings, and are the first cause of disease affecting the health of the Chinese population.

In many countries in the world, especially developed countries, atherosclerotic cardiovascular and cerebrovascular diseases are also the number one cause of death. Among them, atherosclerosis leads to coronary myocardial infarction and stroke account for the main proportion. By 2035, more than 130 million adults (45.1%) in the United States are projected to have some form of cardiovascular disease, and the total cost of cardiovascular disease will be as high as $1.1 trillion.

It is generally believed that abnormal blood lipid metabolism and hyperlipidemia play an important role in the formation of atherosclerotic plaques and are one of the core lesions. Blood lipid is the general term for various lipids in the blood, the most important of which are cholesterol and triglycerides, triglycerides are also called neutral fats, and other important lipids include lipoproteins, including low-density lipoproteins and HDL. The average blood cholesterol content of healthy people is between 2.8-5.17mmol/L, and the average blood triglyceride content is between 0.56-1.7mmol/L. Whether it is an increase in cholesterol content, an increase in triglyceride content, or an increase in both, it is collectively referred to as hyperlipidemia.

The "China Cardiovascular Health and Disease Report 2019" released by the National Health and Family Planning Commission in 2019 shows that 400 million Chinese people have dyslipidemia, with a prevalence rate of 40.40%, of which the prevalence rate of hypercholesterolemia is 4.9%, and high triglycerides The prevalence of hyperemia was 13.1%, and the prevalence level showed a trend of increasing year by year. This poses a severe challenge to the treatment of dyslipidemia and the reduction of the risk of atherosclerotic plaque formation in my country.

At present, there is no specific and effective drug for the prevention and treatment of atherosclerotic plaque in the world. Therefore, the treatment of hyperlipidemia is currently one of the main clinical treatment measures to prevent the formation of atherosclerotic plaque. At present, there are many kinds of hypolipidemic drugs clinically used, mainly statins and fibrates. Although the specific mechanism is different, they mainly work by directly acting on the synthetic and metabolic pathways of fat. Due to the high probability of blood lipid rebound after drug withdrawal, chemically synthesized blood lipid-lowering drugs need to be taken for a long time, which not only leads to the loss of economic resources, but also greatly increases the probability of toxic and side effects. For example, long-term use is often accompanied by side effects of varying degrees, including muscle pain, liver and kidney function damage, etc. In addition, the use of chemical hypolipidemic drugs cannot fundamentally prevent and control the formation and development of vascular plaques, and has a limited effect on reducing the death caused by atherosclerotic cardiovascular and cerebrovascular diseases.

Drugs targeting cardiovascular and cerebrovascular diseases based on traditional Chinese natural medicines mainly include Tongxinluo Capsules, Compound Danshen Dripping Pills, and Shexiang Baoxin Pills, etc., which are common drugs for the prevention and treatment of coronary heart disease and angina pectoris on the market. For blood lipids, there are Guangdong Hongxing Jiangzhi Pills, Chengdu Di'ao Zhibituo, Beijing Weixin Xuezhikang, etc. It can be seen from the instructions of these medicines that there are more or less certain side effects. But more critically, these drugs lack effective and verifiable prevention and ablation of arterial plaque. And it can be seen from literature reports that these drugs are usually recommended for long-term use, and used simultaneously with chemical lipid-lowering drugs, or mainly recommended for the elderly.

Therefore, there is a strong clinical demand for traditional Chinese medicines that can prevent and treat atherosclerotic plaque, ischemic heart disease, elevated blood lipids, and elevated triglycerides, and the social and market demands are huge.

The object of the present invention is to provide a kind of traditional Chinese medicine composition, its preparation method and its preparation in the medicine that is used for preventing or treating atherosclerotic plaque formation, ischemic heart disease, blood lipid elevation, triglyceride elevation etc. application. Clinical treatment practice shows that the traditional Chinese medicine composition of the present invention has an excellent effect of slowing down the formation of atherosclerotic plaque and removing atherosclerotic plaque. Triglycerides have a good effect. The animal model study of atherosclerotic plaque formation shows that the traditional Chinese medicine composition has an obvious effect of ablation and reduction of arterial plaque.

The inventors of the present invention have studied Chinese traditional medicine and medicinal material theory for a long time, and combined with clinical practice, proposed a kind of medicine that is obviously different from modern medicine and is used for the prevention and treatment of atherosclerotic plaque formation, ischemic heart disease, and elevated blood lipids. , Medication regimen for drugs that raise triglycerides. We believe that the core cause of hyperlipidemia and atherosclerosis can be summed up in the logic and language of traditional Chinese medicine as follows: phlegm enters the blood. If it enters the context of modern medicine, it is similar to blood viscosity. Blood viscosity is not only the cause of hyperlipidemia and atherosclerosis, but also a symptom of phlegm and fluid entering the blood. Since the phlegm fluid entering the blood in traditional Chinese medicine is manifested as blood viscosity in modern medicine, we believe that its regulation and treatment is the core and effective way to prevent and treat hyperlipidemia and atherosclerosis.

"Phlegm drink" is defined in the "Emperor's Internal Classic" as the water from the meridian, that is, a kind of body fluid in the circulation and metabolism. The thicker body fluid is called phlegm, and the thinner one is called drink, collectively called phlegm drink. Most of the "phlegm drink" in traditional Chinese medicine refers to the viscous or thin liquid in the digestive tract, lungs and respiratory tract. This kind of liquid is difficult to be metabolized, and even if it is excreted, it will continue to be produced from the digestive tract or respiratory tract. , endlessly. These viscous liquids can also overflow from the digestive tract and respiratory tract and remain under the skin, in the muscles, in the bones and joints, even in the internal organs and the brain, and become various masses, cysts, polyps, and even tumors are also considered to be related to phlegm retention. Individuals, traditional Chinese medicine believes that many diseases are related to this kind of mucus that is difficult to be excreted by the body and difficult to be metabolized. However, Chinese traditional medicine lacks the relationship and discussion on the relationship between phlegm fluid entering the blood and blood viscosity.

In modern medicine, dozens of biochemical indicators are included under the concept of "blood viscosity". For example, some indicators of hyperlipidemia (serum total cholesterol, low-density cholesterol, high-density cholesterol, apolipoprotein, triglycerides), some indicators of hyperglycemia (fasting blood glucose, glycated hemoglobin, fasting insulin, C-peptide, glycated Serum protein, fructosamine), indicators of platelets (number of platelets, degree of platelet adhesion, degree of platelet sedimentation, etc.), some indicators of red blood cells (number of red blood cells, degree of erythrocyte sedimentation, degree of adhesion of red blood cells, volume of hematocrit, deformability of red blood cells, The size of red blood cells), blood viscosity itself measurement indicators (apparent viscosity, relative viscosity, reduced viscosity, specific viscosity, etc.) and some other related indicators (fibrinogen, immunoglobulin, etc.). All of the above indicators have a relatively close influence on blood viscosity. The manifestations of blood viscosity vary. Modern medicine has not yet provided a reasonable and recognized cause of the disease, and its treatment is still at the stage of targeting certain indicators. For example, taking drugs to control hyperlipidemia and hyperglycemia. However, since the high blood viscosity has not been fundamentally resolved, the duration of the lipid-lowering and blood-sugar-lowering effects is short, and long-term use is required, and the curative effect cannot be achieved.

When phlegm drink enters the blood, it will cause blood viscosity, which will greatly increase the risk of hyperlipidemia and blood sugar, which will lead to atherosclerosis, blockage of blood vessels, and heart, brain and kidney diseases. Based on this theory, we have developed a high-efficiency and long-acting traditional Chinese medicine composition for preventing or atherosclerotic plaque formation, ischemic heart disease, elevated blood lipids, and elevated triglycerides in clinical medical practice.

The invention provides a traditional Chinese medicine composition, which includes the following raw materials in parts by weight: 3-20 parts of raw rhubarb, 3-20 parts of white peony root, 3-20 parts of dried ginger, and 3-25 parts of leech; preferably, The traditional Chinese medicine composition of the present invention comprises the following raw materials in parts by weight: 5-15 parts of raw rhubarb, 5-15 parts of Radix Paeoniae Alba, 5-15 parts of dried ginger, and 7-15 parts of leeches; more preferably, the traditional Chinese medicine of the present invention The composition comprises the following raw materials in parts by weight: 10 parts of raw rhubarb, 10 parts of white peony root, 10 parts of dried ginger and 10 parts of leech. Further preferably, the traditional Chinese medicine composition of the present invention is made of the above-mentioned raw materials in parts by weight.

The invention provides a traditional Chinese medicine composition, which includes the following raw materials in parts by weight: 3-20 parts of raw rhubarb, 3-20 parts of white peony root, 3-20 parts of dried ginger, 3-25 parts of leech, 3-20 parts of Atractylodes macrocephala. 20 parts; preferably, the Chinese medicine composition of the present invention comprises the raw material drug by following parts by weight: 5-15 parts of raw rhubarb, 5-15 parts of Radix Paeoniae Alba, 5-15 parts of dried ginger, 7-15 parts of leech, Atractylodes macrocephala 5-15 parts; more preferably, the traditional Chinese medicine composition of the present invention includes the following raw materials in parts by weight: 10 parts of raw rhubarb, 10 parts of white peony root, 10 parts of dried ginger, 10 parts of leech, and 10 parts of Atractylodes macrocephala. Further preferably, the traditional Chinese medicine composition of the present invention is made of the above-mentioned raw materials in parts by weight.

The invention provides a traditional Chinese medicine composition, which comprises the following raw materials in parts by weight: 5-35 parts of Bupleurum, 5-30 parts of Citrus aurantii, 3-20 parts of raw rhubarb, 3-20 parts of white peony root, dried ginger 3-20 parts, 3-25 parts of leech, 3-20 parts of Baizhu; 5-15 parts of Rhubarb, 5-15 parts of Radix Paeoniae Alba, 5-15 parts of Dried Ginger, 7-15 parts of Leech, 5-15 parts of Atractylodes Rhizome; more preferably, the Chinese medicine composition of the present invention comprises the following raw materials in parts by weight Medicine: 20 parts of Bupleurum, 15 parts of Citrus aurantium, 10 parts of raw rhubarb, 10 parts of white peony root, 10 parts of dried ginger, 10 parts of leech, and 10 parts of Atractylodes macrocephala. Further preferably, the traditional Chinese medicine composition of the present invention is made of the above-mentioned raw materials in parts by weight.

The invention provides a traditional Chinese medicine composition, which comprises the following raw materials in parts by weight: 5-35 parts of Bupleurum, 5-30 parts of Citrus aurantii, 3-20 parts of raw rhubarb, 3-20 parts of white peony root, dried ginger 3-20 parts, 3-25 parts of leeches, 3-20 parts of licorice, 3-20 parts of Atractylodes macrocephala, 3-45 parts of raw oysters; preferably, it contains the following raw materials by weight: Bupleurum 15-30 parts , 10-20 parts of citrus aurantium, 5-15 parts of raw rhubarb, 5-15 parts of white peony, 5-15 parts of dried ginger, 7-15 parts of leeches, 5-15 parts of licorice, 5-15 parts of Atractylodes macrocephala, raw oysters 10-35 parts; more preferably, it comprises the raw material drug by following parts by weight: Bupleurum 20 parts, Citrus aurantium 15 parts, raw rhubarb 10 parts, Radix Paeoniae Alba 10 parts, dried ginger 10 parts, leech 10 parts, 10 parts of licorice, 10 parts of Atractylodes macrocephala, 30 parts of raw oysters. Further preferably, the traditional Chinese medicine composition of the present invention is made of the above-mentioned raw materials in parts by weight.

The invention provides a traditional Chinese medicine composition, which includes the following raw materials in parts by weight: 5-35 parts of Bupleurum, 5-30 parts of Citrus aurantium, 3-20 parts of raw rhubarb, 1-20 parts of Scutellaria baicalensis, 3 parts of white peony -20 parts, 3-20 parts of dried ginger, 3-25 parts of leeches, 3-20 parts of licorice, 3-20 parts of Codonopsis pilosula, 3-20 parts of Atractylodes macrocephala, 3-45 parts of raw oysters; preferably, the Chinese medicine composition of the present invention , comprising the following raw materials in parts by weight: 15-30 parts of Bupleurum bupleurum, 10-20 parts of Citrus aurantii, 5-15 parts of raw rhubarb, 2-10 parts of Scutellaria baicalensis, 5-15 parts of white peony, 5-5 parts of dried ginger 15 parts, 7-15 parts of leeches, 5-15 parts of licorice, 5-15 parts of Codonopsis pilosula, 5-15 parts of Atractylodes macrocephala, 10-35 parts of raw oysters; more preferably, the Chinese medicine composition of the present invention contains Raw materials: 20 parts of Bupleurum, 15 parts of Citrus aurantium, 10 parts of raw rhubarb, 3 parts of Scutellaria baicalensis, 10 parts of white peony, 10 parts of dried ginger, 10 parts of leech, 10 parts of licorice, 10 parts of Codonopsis, 10 parts of Atractylodes macrocephala, 30 servings of raw oysters. Further preferably, the traditional Chinese medicine composition of the present invention is made of the above-mentioned raw materials in parts by weight.

The invention provides a traditional Chinese medicine composition, which includes the following raw materials in parts by weight: 3-20 parts of raw rhubarb, 3-20 parts of dried ginger, 3-20 parts of white peony root, 3-25 parts of leech, 3-20 parts of licorice 20 parts, 3-45 parts of raw oysters, 3-20 parts of paeonol, 2-15 parts of peach kernels; preferably, the Chinese medicine composition of the present invention comprises the following raw materials in parts by weight: 5-15 parts of raw rhubarb , 5-15 parts of dried ginger, 5-15 parts of paeonol, 3-12 parts of peach kernel, 5-15 parts of white peony, 7-15 parts of leeches, 5-15 parts of licorice, 10-35 parts of raw oysters; more preferably , the traditional Chinese medicine composition of the present invention, it comprises the raw material drug by following weight parts: 10 parts of raw rhubarb, 10 parts of dried ginger, 10 parts of Radix Paeoniae Alba, 10 parts of leeches, 10 parts of licorice, 30 parts of raw oysters, 10 parts of paeonol 6 servings of peach kernels. Further preferably, the traditional Chinese medicine composition of the present invention is made of the above-mentioned raw materials in parts by weight.

In the above composition, parts are parts by weight, and the weight is calculated based on crude drugs. It can be increased or decreased according to the corresponding proportion during production. For example, the unit of kilogram or ton can be used for large-scale production, and the weight can be increased or decreased, but the weight ratio of raw medicinal materials between the components is not the same. Change.

The relevant raw materials of the present invention are introduced as follows:

Bupleurum, the medicinal part is the dried root of Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd. It has the effects of reconciling the exterior and interior, soothing the liver and promoting yang.

Citrus aurantium is the dry young fruit of Rutaceae lime and its cultivars or sweet orange (Immature Bitter Orange, Immature Sweet Orange, Fructus Aurantii Immaturus). It has the effects of dispelling qi and eliminating stagnation, resolving phlegm and dissipating ruffian.

Raw rhubarb, this product is the dry root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf., or medicinal rhubarb (Rheum officinale Baill.) . It has the effects of purging heat and poison, breaking stagnant stagnation, and promoting blood stasis.

Scutellaria baicalensis, the dried root of Scutellaria baicalnsis Geprgi, a perennial herb of Lamiaceae. It has the effects of clearing away heat and dampness, purging fire and detoxification, stopping bleeding, and preventing miscarriage.

Radix Paeoniae Alba is the dried root of Paeonia lactiflora Pall. It has the effects of warming the yang and removing dampness, replenishing the deficiency, and invigorating the spleen and stomach.

Dried ginger is the dried rhizome of Zingiber oj-jicinale Rosc. Excavated in winter, remove fibrous roots and sediment, and dry in the sun or at low temperature. Those who take fresh slices and dry them in the sun or at low temperature are called "dried ginger slices". It has the effects of warming the middle and dispelling the cold, returning to the yang and dredging the veins, warming the lungs and transforming the drink.

Leeches are the dried whole body of leeches (Whitm.ania Pigra Whitman), leeches (Hirudo nipponica Whitman) or willow leaf leeches (Whitmania acranutata Whitman) of the leech family. It is caught in summer and autumn, scalded to death with boiling water, and dried in the sun or at low temperature. It has the effects of removing blood stasis and promoting menstrual flow, removing blood stasis and eliminating symptoms.

Licorice (Glycyrrhiza uralensis Fisch), alias: old country, sweet grass, Ural licorice, sweet root. Legumes and licorice are perennial herbs, and the medicinal parts are roots and rhizomes. It is used for deficiency of heart qi, palpitations, intermittent pulse, deficiency of spleen and stomach qi, fatigue and fatigue, and to reconcile the potency of certain drugs and the reaction to the gastrointestinal tract.

Codonopsis Codonopsis is the dry root of Codonopsis Codonopsis, Suhua Codonopsis, or Sichuan Codonopsis. It has the effects of nourishing the middle, replenishing qi, and promoting body fluid.

Atractylodes macrocephala, the dry rhizome of Atractylodes macrocephala Koidz. It has the effects of invigorating the spleen and replenishing qi, drying dampness and diuresis, and antiperspirant.

Raw oysters are the shells of Ostrea gigas Thunberg, Ostrea talienwhanensis Crosse or Ostrea rivularis Gould. It has the effects of calming the nerves, suppressing yang and nourishing yin, softening and resolving hard masses.

Tree Peony Bark, also known as Moutan Bark, the name of traditional Chinese medicine, is the dry root bark of the perennial deciduous shrub plant Paeonia suffruticosa Andr. of Ranunculaceae Paeoniae. It has anti-inflammation, inhibition of platelets, central nervous system inhibition and anti-atherosclerosis.

Peach kernel is the dry mature seed of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch. It has the effects of promoting blood circulation and removing blood stasis, moistening the intestines and laxative, relieving cough and relieving asthma.

The prescription of the present invention is formed on the basis of sufficient research on Shanghanlunjing prescriptions and corresponding medicinal materials, combined with clinical practice. In TCM theory, ischemic cardiovascular and cerebrovascular diseases belong to the category of "vertigo" and "chest pain". The most common cause is stagnation of qi and blood stasis or insufficient qi and blood, and poor blood flow caused by weak blood push, which leads to insufficient blood supply and oxygen supply to the cardiovascular and cerebrovascular vessels, resulting in symptoms of chest tightness, chest pain, and dizziness. The main prescription of this medicine is to remove phlegm, and phlegm is the first of internal evils. The main pathology of arterial plaque is the disease caused by blood viscosity, lipodystrophy and arterial inflammatory reaction. Drinking is the main job. Through the combination of traditional Chinese medicines, this prescription can relieve blood viscosity, conduct qi conduction to reduce turbidity, gradually remove arterial plaques, and achieve the curative effect of significantly improving the symptoms of ischemic heart and brain diseases.

In this prescription, raw rhubarb and Bupleurum are used as monarch drugs, dried ginger, raw Atractylodes macrocephala, and Codonopsis pilosula are used as ministerial drugs, leeches, raw oysters, white peony root, citrus aurantium, scutellaria baicalensis, or paeonol, peach kernels are used as adjuvant drugs, and licorice is used as adjuvant drugs. make medicine.

The traditional Chinese medicine composition of the present invention can obtain pharmaceutical active substances through extraction or other known methods in the art. The pharmaceutical active substance can be obtained by extracting natural compound drug raw materials separately, or by jointly extracting natural compound drug raw materials.

Preferably, it is prepared by decocting. More preferably, the preparation method of the traditional Chinese medicine composition of the present invention comprises weighing the crude drug, adding 4-12 times the amount of water for the first time, and incubating at 70-95°C, preferably 70-85°C, for 30-120 minutes to obtain the first decoction Boiling liquid: add 3-10 times of water for the second time, keep warm at 70-95°C, preferably 70-85°C, for 30-120 minutes to obtain the second boiling liquid; combine the second boiling liquid, filter, and combine the filtrates. More preferably, the preparation method of the traditional Chinese medicine composition of the present invention comprises weighing the crude drug, adding 8 times the amount of water for the first time, boiling and keeping it at 80°C or 75°C for 60 minutes to obtain the decoction for the first time; adding water for the second time 6 times the amount, boiled and kept at 80°C or 75°C for 60 minutes to obtain the second decoction; combine the second decoction, filter, and combine the filtrates. The obtained extract can be further concentrated into the form of extract, which can be dry extract or liquid extract. It is preferably concentrated under reduced pressure (-0.05Mpa, 60°C) to a relative density of 1.05-1.15 (60°C).

The traditional Chinese medicine composition of the present invention can also be prepared by adding pharmaceutically acceptable carriers if necessary. The pharmaceutical active substance extracted or processed from the traditional Chinese medicine composition of the present invention accounts for 0.1-99.9% by weight in the preparation, and the rest is a pharmaceutically acceptable carrier.

The Chinese medicine composition of the present invention can be any pharmaceutically acceptable dosage form, and these dosage forms include: decoction, lozenge, sugar-coated lozenge, film-coated lozenge, enteric-coated lozenge, capsule, hard capsule, soft capsule, oral Liquid, buccal, granule, granule, pill, powder, ointment, elixir, suspension, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch. Oral dosage forms are preferred, and decoctions, capsules, lozenges, oral liquids, granules, pills, powders, pills, ointments, etc. are more preferred. Decoctions, granules, capsules and lozenges are most preferred.

The present invention further provides the application of the traditional Chinese medicine composition in the preparation of medicines for preventing or controlling the formation of vascular plaque.

The present invention further provides the application of the traditional Chinese medicine composition in the preparation of medicines for preventing or treating atherosclerotic plaque.

The present invention further provides the application of the traditional Chinese medicine composition in the preparation of medicines for preventing or treating atherosclerotic plaque ischemic heart and brain diseases.

The present invention further provides the application of the traditional Chinese medicine composition in the preparation of medicines for preventing or treating hyperlipidemia.

The present invention further provides the application of the traditional Chinese medicine composition in the preparation of medicines for preventing or treating elevated triglycerides.

The present invention further provides the application of the traditional Chinese medicine composition in the preparation of medicaments for preventing or treating elevated cholesterol.

The present invention further provides the application of the traditional Chinese medicine composition in the preparation of medicines for preventing or treating hyperlipidemia.

The present invention further provides the application of the traditional Chinese medicine composition in the preparation of medicines for preventing or treating chronic metabolic diseases.

The present invention further provides a method for preventing or controlling the formation of vascular plaque, which comprises administering a preventive or therapeutic effective amount of the above-mentioned traditional Chinese medicine composition of the present invention to a person in need.

The present invention further provides a method for preventing or treating atherosclerotic plaque, which comprises administering a preventive or therapeutically effective amount of the above-mentioned traditional Chinese medicine composition of the present invention to a person in need.

The present invention further provides a method for preventing or treating atherosclerotic plaque-ischemic heart and brain diseases, comprising administering a preventive or therapeutic effective amount of the above-mentioned traditional Chinese medicine composition of the present invention to a person in need thereof.

The present invention further provides a method for preventing or treating elevated blood lipids, comprising administering a preventive or therapeutically effective amount of the above-mentioned traditional Chinese medicine composition of the present invention to a person in need.

The present invention further provides a method for preventing or treating elevated triglycerides, comprising administering a preventive or therapeutically effective amount of the above-mentioned traditional Chinese medicine composition of the present invention to a person in need.

The present invention further provides a method for preventing or treating elevated cholesterol, which comprises administering a preventive or therapeutically effective amount of the above-mentioned traditional Chinese medicine composition of the present invention to a person in need.

The present invention further provides a method for preventing or treating hyperlipidemia, comprising administering a preventive or therapeutic effective amount of the above-mentioned traditional Chinese medicine composition of the present invention to a person in need.

The present invention further provides a method for preventing or treating chronic metabolic diseases, comprising administering a preventive or therapeutically effective amount of the above-mentioned traditional Chinese medicine composition of the present invention to a person in need.

The traditional Chinese medicine composition of the present invention can be taken one to three times a day for 14 days as a course of treatment, and the treatment of patients with atherosclerotic plaque requires 6-12 courses of treatment, and the drug is stopped for 3 days between each course of treatment. When formulated in unit dosage form, 1-10 doses are administered each time. The traditional Chinese medicine composition of the present invention can be concentrated and dried to obtain dry extract powder after being decocted in water, and then an appropriate amount of excipients can be added to make granules, which can be taken one to three times a day, 1-2 doses each time, or can be Put it into capsules or make lozenges, take it one to three times a day, take 2-8 capsules or lozenges each time, the specific usage and dosage can be adjusted according to the actual situation of the patient.

The traditional Chinese medicine formula of the present invention is an innovative construction based on the theory and practice of "phlegm drink enters the blood" and Treatise on Febrile Diseases. The inventors of the present invention have formed the formula and determined the proportion of the components on the basis of fully studying and considering the properties and efficacy of the components of the Chinese herbal medicines, combined with clinical practice. The traditional Chinese medicine composition of the invention has obvious clinical effects on preventing the occurrence and progression of atherosclerotic plaques and ablating atherosclerotic plaques. Clinical treatment practice also shows that the traditional Chinese medicine formula of the present invention has excellent blood lipid reduction, especially for cases with severe blood triglyceride elevation (triglyceride> 5.6 mmol/L), the effect of lowering blood triglyceride is especially obvious.

The present invention will be further described in detail below in conjunction with specific embodiments, and the given examples are only for clarifying the present invention, not for limiting the scope of the present invention.

The test methods in the following examples, unless otherwise specified, are conventional methods; the raw materials, reagent materials, etc. used in the following examples, unless otherwise specified, are commercially available products.

In the description of this application, unless otherwise specified, the amount of solvent used in the preparation process of each test drug is the volume multiple based on the weight of the medicinal material.

Embodiment 1 The preparation of Chinese medicine composition of the present invention

Sample A: Weigh the following raw materials: 20 parts of Bupleurum, 15 parts of Citrus aurantii, 10 parts of raw rhubarb, 10 parts of white peony, 10 parts of dried ginger, 10 parts of leech, 10 parts of Atractylodes macrocephala, boil and extract two For the first time, add 8 times the amount of water for the first time, and heat it at 75 degrees centigrade for 60 minutes after boiling to obtain a decoction; Decoction, filtered, combined filtrate. Divide the filtrate into 14 equal volumes, provide a 7-day supply, and store at 4°C.

Sample B: Weigh the following raw materials: Bupleurum 20g, Zhishi 15g, Rhubarb 10g, Scutellaria baicalensis 3g, Paeoniae Alba 10g, Dried ginger 10g, Leech 10g, Licorice 10g, Codonopsis 10g, Atractylodes macrocephala 10g, Raw oyster 30g, set Boil twice in a closed container, add 8 times the amount of water for the first time, and heat it at 75 degrees Celsius for 60 minutes after boiling to obtain a decoction; add 6 times the amount of water for the second time, and heat it at 70 degrees Celsius for 60 minutes after boiling to obtain the second decoction Boil the liquid; combine the second decocting liquid, filter, and combine the filtrate. Divide the filtrate into 14 equal volumes, provide a 7-day supply, and store at 4°C.

Sample C: Weigh the following raw materials: Bupleurum bupleuri 20g, Citrus aurantium 15g, raw rhubarb 10g, white peony root 10g, dried ginger 10g, leech 10g, licorice 10g, Atractylodes macrocephala 10g, raw oyster 30g, boil in a closed container for two For the first time, add 8 times the amount of water for the first time, and heat it at 75 degrees centigrade for 60 minutes after boiling to obtain a decoction; Decoction, filtered, combined filtrate. Divide the filtrate into 14 equal volumes, provide a 7-day supply, and store at 4°C.

Sample D: Weigh the following raw materials: 10g of raw rhubarb, 10g of white peony root, 10g of dried ginger, 10g of leech, 10g of licorice, 10g of paeonol, 6g of peach kernel, and 30g of raw oyster. Add 8 times the amount of water for the first time, and heat it at 75 degrees Celsius for 60 minutes after boiling to obtain a decoction; add 6 times the amount of water for the second time, and heat it at 70 degrees Celsius for 60 minutes after boiling to obtain the second decoction; Combine the second decoction, Filter and combine the filtrates. Divide the filtrate into 14 equal volumes, provide a 7-day supply, and store at 4°C.

Embodiment 2: typical case of treatment of atherosclerosis

Example 2-1:

Chen, male, went to the Zhejiang Huzhou Ruibo Traditional Chinese Medicine Outpatient Department (No. 322, Meizhou Road, Huzhou, Zhejiang Province) during 2021. During the visit, Chen's bilateral common carotid artery sclerosis plaques formed, and there were 6 obvious plaques. Plaques, the sizes of which are plaque 1 (15.2*1.6mm), plaque 2 (10.7*2.0mm), plaque 3 (10.2*2.1mm), plaque 4 (5.5*1.0mm), plaque 5 (5.8 *1.6mm) and plaque 6 (5.5*1.7mm). Take one part of the filtrate prepared in the sample B of the above embodiment after breakfast and dinner. After 7 courses of treatment (14 days/course of treatment), bilateral common carotid arteriosclerotic plaques became smaller or disappeared, of which plaques 4, 5, and 6 completely disappeared, and the other three plaques 1, 2 , 3 are significantly reduced, and the sizes are reduced to 8.8*2.4mm, 7*2.4mm and 6.8*1.7mm respectively.

Example 2-2:

Li, female, 65 years old, from 2020 to 2021, went to Zhejiang Huzhou Ruibo Traditional Chinese Medicine Outpatient Department (No. 322 Meizhou Road, Huzhou City, Zhejiang Province) to see a doctor. There are 4 plaques, the sizes are plaque 1 (12.1*2.6mm), plaque 2 (10.2*2.0mm), plaque 3 (10.0*1.9mm) and plaque 4 (5.6*2.0mm). Take one part of the filtrate prepared in the sample B of the above embodiment after breakfast and dinner. After 12 courses of treatment (14 days/course of treatment), the bilateral common carotid artery sclerotic plaques became smaller or disappeared, and the two plaques 2 and 4 disappeared completely, and the remaining two plaques 1 and 4 disappeared completely. 3 significantly reduced, the size was reduced to 3.9*2.5mm and 2.6*2.1mm respectively.

Example 3 Study on the Influence of the Traditional Chinese Medicine Composition of the Present Invention on ApoE-/- Mice Formation of Atherosclerotic Plaque

3.1. Experimental purpose: ApoE-/- mice were used to establish an atherosclerosis model to explore the effect of the tested samples on atherosclerosis.

3.2. Test article

3.2.1. CS001-sample A; dry extract powder sample 1 prepared in Example 1-1. Properties: brown powder; storage conditions: 2-8 ℃, dry.

3.2.2. CS001-sample B; dry extract powder sample 2 prepared in Example 1-1. Properties: brown powder; storage conditions: 2-8 ℃, dry.

3.2.3. CS001-sample C; dry extract powder sample 3 prepared in Example 1-1. Properties: brown powder; storage conditions: 2-8 ℃, dry.

3.2.4. CS001-sample D; dry extract powder sample 4 prepared in Example 1-1. Properties: brown powder; storage conditions: 2-8 ℃, dry.

3.3 Reference substance: Rosuvastatin Calcium Tablets (can be fixed); shape: pink film-coated tablet; specification/purity: 10 mg/tablet; packaging: aluminum-plastic blister packaging; production unit: AstraZeneca Pharmaceuticals (China) Ltd.; storage conditions: sealed and dry.

3.4 Test solvents, emulsifiers and other media:

Name: pure water

Manufacturer: Zhuhai Baishitong Biotechnology Co., Ltd.;

3.5 Main instruments and reagents

Centrifuge, model: TG16WS; product of Hunan Xiangyi Laboratory Instrument Development Co., Ltd.;

ME104E electronic analytical balance, sensitivity: 0.1mg, Mettler Toledo, Switzerland;

Electronic balance, sensitivity: 0.1g, model: JE2001; Shanghai Puchun Measuring Instrument Co., Ltd.

TC, TG, HDL-C, LDL-C kits: Shanghai Kehua Bioengineering Co., Ltd.

3.6 Experimental system

Animal information: ApoE-/- mice, SPF grade, 160, female, 2 months old;

Animal source: ApoE-/- mice were purchased from Jiangsu Jicui Yaokang Biotechnology Co., Ltd. (production license number: SCXK (Su) 2018-0008). Animal certificate number: 99822700020300, 320727210100778554, experiment certificate number: 00293582.

Reason for selection: request by the entrusting party.

Feeding management: Animals were kept in the SPF grade animal room of the Experimental Animal Center of Zhuhai Baishitong Biotechnology Co., Ltd. Animal feeding conditions: 4 animals/cage in groups, feeding temperature and humidity: 20-26°C, 40-70%, with 12h:12h day and night intermittent lighting; the conditions in the feeding room are always kept stable to ensure the reliability of the test results. During the experiment, the animals were fed with the corresponding pellet feed according to the experimental requirements, and the common feed was provided by Jiangsu Medison Biomedical Co., Ltd. Animals had free access to food and water.

Identification method: Ear tagging method is adopted, and the ear tag number cage is identified with double number marks.

Euthanasia: 50mg/kg Sutai 50 and 10mg/kg Sumianxin Ⅱ combined with anesthesia, blood collection and sacrifice, the corpse was temporarily stored in the cadaver freezer, and Zhuhai Baishitong Biotechnology Co., Ltd. uniformly carried out pollution-free treatment.

Quarantine observation: Quarantine for purchased animals for 7 days. During this period, the animals were checked once a day, and any unhealthy animals were found to be removed immediately, and healthy animals were selected for experiments.

3.7 Dose Design and Grouping

Dosage design basis: request of the entrusting party.

3.8 Experimental method

3.8.1. Preparation of the test solution:

3.8.1.1. Sample A

Super high dose of sample A (0.521g/ml): Accurately weigh 2.13g of sample A, add 15ml of pure water, stir well, and obtain 0.521g/ml super high dose suspension of sample A.

Sample A high dose (0.261g/ml): take 4ml of sample A super high dose suspension, add 4ml of purified water, stir well, and get 0.261g/ml sample A high dose suspension.

Medium dose of sample A (0.13g/ml): Take 2ml of super high dose suspension of sample A, add 6ml of purified water, stir well, and obtain medium dose suspension of 0.13g/ml sample A.

Sample A low dose (0.065g/ml): Take 1ml of sample A super high dose suspension, add 7ml of purified water, stir well, 0.065g/ml sample A low dose suspension.

3.8.1.2. Sample B

Super high dose of sample B (0.521g/ml): Accurately weigh 2.7g of sample B, add 15ml of pure water, stir well, and obtain 0.521g/ml super high dose suspension of sample B.

Sample B high dose (0.261g/ml): take 4ml of sample B super high dose suspension, add 4ml of purified water, stir well, and obtain 0.261g/ml sample B high dose suspension.

Medium dose of sample B (0.13g/ml): take 2ml of super high dose suspension of sample B, add 6ml of purified water, stir well, and obtain medium dose suspension of 0.13g/ml sample B.

Sample B low dose (0.065g/ml): take 1ml of sample B super high dose suspension, add 7ml of purified water, stir well, 0.065g/ml sample B low dose suspension.

3.8.1.3. Sample C

Super high dose of sample C (0.521g/ml): Accurately weigh 1.23g of sample C, add 15ml of pure water, stir evenly, and obtain 0.521g/ml super high dose suspension of sample C.

Sample C high dose (0.261g/ml): Take 4ml of sample C super high dose suspension, add 4ml of purified water, stir evenly to obtain 0.261g/ml sample C high dose suspension.

Medium dose of sample C (0.13g/ml): Take 2ml of super high dose suspension of sample C, add 6ml of purified water, stir evenly, and obtain medium dose suspension of sample C of 0.13g/ml.

Sample C low dose (0.065g/ml): Take 1ml of sample C super high dose suspension, add 7ml of purified water, stir well, 0.065g/ml sample C low dose suspension.

3.8.1.4. Sample D

Super high dose of sample D (0.521g/ml): Accurately weigh 2.22g of sample D, add 15ml of pure water, stir evenly, and obtain 0.521g/ml super high dose suspension of sample D.

Sample D high dose (0.261g/ml): take 4ml of sample D super high dose suspension, add 4ml of purified water, stir well, and obtain 0.261g/ml sample D high dose suspension.

Medium dose of sample D (0.13g/ml): take 2ml of super high dose suspension of sample D, add 6ml of purified water, stir well, and obtain medium dose suspension of sample D of 0.13g/ml.

Sample D low dose (0.065g/ml): take 1ml of sample D super high dose suspension, add 7ml of purified water, stir well, 0.065g/ml sample D low dose suspension.

3.8.2. Preparation of reference solution

Rosuvastatin (0.33mg/ml): Take 1 tablet of rosuvastatin, grind it into powder, add 30ml of purified water, stir to dissolve, shake well before administration Dose design and grouping

3.8.3. High-fat and high-cholesterol model feed: Add 20.0% sucrose, 5% lard, 1.0% cholesterol, 0.1% sodium cholate, appropriate amount of casein, calcium bicarbonate, stone powder, etc. to the maintenance feed. In addition to crude fat, the moisture, 10 crude protein, crude fat, crude fiber, crude ash, calcium, phosphorus, and calcium:phosphorus of the model feed must meet the national standards for maintenance feed. Provided by the Experimental Animal Center of Zhuhai Baishitong Company.

3.8.4 Modeling method: 160 SPF-grade ApoE-/- mice were raised in SPF-grade environmental facilities. After passing the quarantine for 3 days, they were adaptively fed for 14 days. All ApoE-/- mice were fed with high-fat diet for 30 days. After 30 days, the groups were randomly divided into model control group 1 and 2, rosuvastatin group (positive group 1 and 2), samples A, B, C, and D (low-dose group, middle-dose group, and group, high-dose group, ultra-high-dose group), 8 rats/group. All ApoE-/- mice were fed with high-fat diet for 30 days after modeling, and then returned to normal maintenance diet.

3.8.5 Administration method: The mice in the positive control group and each test sample group were intragastrically given the corresponding drug solution at 20 mL/kg body weight every day, and the model control group was given the same volume of purified water, once a day, for 60 consecutive days. d. Grouping: Table 1 Table 1 Dosing table of each group group drug no drug concentration Dosing volume Dosage g Crude drug amount /ml mL/10g g Crude drug amount /kg Model control group 1 pure water 8 0 0.2 0 Rosuvastatin positive group 1 Rosuvastatin 8 0.00033 0.2 0.0066 Sample A low dose group Sample A 8 0.065 0.2 1.303 Dose group in sample A Sample A 8 0.13 0.2 2.606 Sample A high dose group Sample A 8 0.261 0.2 5.212 Sample A super high dose group Sample A 8 0.521 0.2 10.424 Sample B low dose group Sample B 8 0.065 0.2 1.303 Dose group in sample B Sample B 8 0.13 0.2 2.606 Sample B high dose group Sample B 8 0.261 0.2 5.212 Model control group 2 pure water 8 0 0.2 0 Rosuvastatin positive group 2 Rosuvastatin 8 0.00033 0.2 0.0066 Sample C low dose group Sample C 8 0.065 0.2 1.303 Sample C middle dose group Sample C 8 0.13 0.2 2.606 Sample C high dose group Sample C 8 0.261 0.2 5.212 Sample C super high dose group Sample C 8 0.521 0.2 10.424 Sample D low dose group Sample D 8 0.065 0.2 1.303 Dose group in sample D Sample D 8 0.13 0.2 2.606 Sample D high dose group Sample D 8 0.261 0.2 5.212 Sample D super high dose group Sample D 8 0.521 0.2 10.424 Sample B super high dose group Sample B 8 0.521 0.2 10.424

3.8.6 Detection indicators:

1) General state: Observe and record the general clinical state of the mice once a day.

2) Body weight: Body weight was measured once at the beginning of the test and at the end of the test. During the test, body weight was measured once a week. Calculate the weight gain of animals on the 30th day of administration (administration D29-administration D1), and the weight gain on 60 days of administration (administration D60-administration D1).

3) TC, TG, LDL-C, HDL-C levels:

TC and TG levels: 30 days, 60 days and 90 days after modeling, each animal was not fasted, blood was collected from the fundus venous plexus after anesthesia, centrifuged at 3000 rpm for 10 minutes, serum was separated, and TC and TG levels were measured.

LDL and HDL levels: On the 60th and 90th days of modeling, each animal was not fasted, blood was collected from the fundus venous plexus after anesthesia, centrifuged at 3000rpm for 10min, the serum was separated, and the levels of LDL and HDL were measured.

C-reactive protein (CRP) level: On the 30th and 90th day of modeling, each animal was not fasted, blood was collected from the fundus venous plexus after anesthesia, centrifuged at 3000rpm for 10min, the serum was separated, and the CRP level was measured.

Pathological examination: After the experiment, the mice were fixed in the supine position, the thorax of the mice was quickly opened, the whole body was perfused with normal saline through the left ventricle, and then fixed with 4% paraformaldehyde. The aortic arch was taken for HE staining and Sirius red staining.

Tissue preservation: After blood collection, animals were sacrificed by exsanguination and serum was collected. All experimental animals were grossly dissected, and heart, liver, kidney and brain tissues were collected. Among them, the heart, some liver, kidney and brain tissues were fixed as tissue samples, and the remaining tissues were cryopreserved. Histopathological examination should be performed when other tissues and organs change in volume, color, texture, etc.

）表示，應用SPSS 21.0軟件進行統計分析；採用順位和檢驗進行統計分析。百分率的比較採用順位和檢驗進行統計分析。檢驗水平α=0.05。 3.9 Data statistics method: All data adopt (

) said, SPSS 21.0 software was used for statistical analysis; the rank sum test was used for statistical analysis. The comparison of percentages was performed statistical analysis using the rank sum test. The test level is α=0.05.

3.10 Results

3.10.1. Daily observation: No death or abnormal reaction occurred in the mice in each group during the experiment.

3.10.2. Weight (see Figure 1-4):

Compared with the model control group, the body weight of the rosuvastatin positive group and each sample group decreased from the second week, and the body weight changes in some weeks were statistically different (P<0.05). Among them, the impact of rosuvastatin positive group on body weight was more obvious than that of each sample treatment group. However, for changes in body weight, no dose-response relationship was observed in each sample treatment group, indicating that changes in body weight had nothing to do with the administered dose.

3.10.3. TC value, TG value, CRP value, LDL value, HDL value (see Table 2-4):

3.10.3.1. TC value:

The TC value of the mice in the ultra-high dose group of sample A was higher than that of the model control group at D30, with a statistical difference (P<0.05). There was no statistical difference in the TC value of the mice in the other administration groups compared with the model control group at each time point (P>0.05).

3.10.3.2. TG value:

The TG value of the mice in the ultra-high dose group of sample A was higher than that of the model control group at D30, with a statistical difference (P<0.05). The TG value of the mice in the sample A high-dose group, sample B low-dose group, sample B medium-dose group, and sample B ultra-high-dose group was lower than that of the model control group at D60, with statistical differences (P<0.05). There was no statistical difference in the TG value of the mice in the other administration groups compared with the model control group at each time point (P>0.05).

3.10.3.3. LDL value:

Sample A medium dose group, sample A high dose group, sample A super high dose group, sample B low dose group, sample B medium dose group, sample B high dose group, sample B super high dose group mice at D30 LDL value Higher than the model control group, with a statistical difference (P<0.05), the LDL value of the mice in the sample A ultra-high dose group and sample B ultra-high dose group was higher than that of the model control group at D60, with a statistical difference (P<0.05 ), the LDL values of mice in the other administration groups were not significantly different from those of the model control group at each time point (P>0.05).

3.10.3.4. HDL values

The HDL value of the mice in the ultra-high dose group of sample A was higher than that of the model control group at D60, and the HDL-C value of the mice in the rosuvastatin group was lower than that of the model control group at D30, with a statistical difference (P<0.05). The HDL-C value of the mice in the ultra-high dose D group was higher than that of the model control group at D30, with a statistical difference (P<0.05). There was no statistical difference in the HDL values of mice in other administration groups compared with the model control group at each time point (P>0.05).

3.10.3.5. CRP value:

The CRP values of mice in sample B low-dose group and sample B ultra-high-dose group were lower than those of the model control group at D60, with statistical difference (P<0.05). CRP value of mice in sample C medium dose group, sample C high dose group, sample C super high dose group, sample D low dose group, sample D medium dose group, sample D high dose group, sample D super high dose group mice at D60 It was lower than the model control group, with statistical difference (P<0.05), and there was no statistical difference in the CRP values of the other administration groups compared with the model control group at each time point (P>0.05).

3.10.4 Pathological test results

The hearts, livers, kidneys, and brains of ApoE-/- mice in the model control group showed varying degrees of inflammatory reactions. The degree of lesion was close to that of the model control group. No other pathological changes were observed in each group.

3.10.5. HE staining results of arterial arch atherosclerotic plaque (Table 5, Figure 5-12).

Table 5, the area and number of atherosclerotic plaques in the arterial arch ((Avg., n=8) HE staining)

Compared with the model control group, the degree of atherosclerotic plaque formation in the positive treatment group and each sample treatment group showed a tendency to alleviate, and the plaque area decreased, and the average plaque area of some groups was the same as that of the model group. Compared with the control group, there was a significant difference (P<0.01 or P<0.05). Among them, compared with the model control group, the mice in the four dose groups of sample B showed a more obvious dose-effect relationship on the area of atherosclerotic plaque in the arterial arch (Figure 8). No significant dose-effect relationship was observed in other groups. No significant dose-response relationship was observed for the number of plaques in each group.

in conclusion

Under the conditions of this experiment, experimental samples A, B, C, and D all showed relatively obvious effects of preventing and ablating arterial plaque. Among them, sample B showed an obvious dose-effect relationship for the removal of arterial plaque. In addition, sample B has the effect of significantly lowering the blood TG value. Sample D showed an obvious effect of inhibiting inflammatory response. Compared with the model control group, the CRP value was significantly reduced in each dose group.

none

Fig. 1 has shown the body weight change of mice after applying various doses of A sample group of the present invention and model control group; Fig. 2 has shown the body weight change of mice after applying various doses of the B sample group of the present invention and the model control group; Fig. 3 has shown the body weight change of mice after applying various doses of the C sample group of the present invention and the model control group; Fig. 4 has shown the body weight change of mice after applying various doses of D sample group of the present invention and model control group; Figure 5 shows the plaque area and arterial lumen area ratio of mice after applying each sample group of the present invention, model control group and rosuvastatin positive group; Figure 6 shows the number of atherosclerotic plaques in mice after applying each sample group, model control group and rosuvastatin positive group of the present invention; Figure 7 shows the changes in the atherosclerotic plaques of mice after applying various doses of A and B sample groups of the present invention, normal group 1, model group 1, and rosuvastatin intervention group 1; Figure 8 shows the changes in the atherosclerotic plaques of mice after applying various doses of C and D sample groups of the present invention, normal group 2, model group 2, and rosuvastatin intervention group 2; Figure 9 shows the plaque area and arterial lumen area ratio of mice after applying the A sample group of the present invention by different doses; Figure 10 shows the plaque area and arterial lumen area ratio of mice after applying the B sample group of the present invention by different doses; Figure 11 shows the plaque area and arterial lumen area ratio of mice after applying the C sample group of the present invention by different doses; Fig. 12 shows the ratio of plaque area to arterial lumen area of mice after applying the D sample group of the present invention according to different doses.

Claims (22)

A traditional Chinese medicine composition, characterized in that it comprises the following raw materials in parts by weight: 5-35 parts of Bupleurum bupleuri, 5-30 parts of Citrus aurantii, 3-20 parts of raw rhubarb, 3-20 parts of white peony root, 3 parts of dried ginger -20 parts, 3-25 parts of leech, 3-20 parts of Atractylodes macrocephala. The traditional Chinese medicine composition as claimed in claim 1 is characterized in that it comprises the following raw materials in parts by weight: Bupleurum bupleurum 15-30 parts, Citrus aurantium 10-20 parts, raw rhubarb 5-15 parts, white peony root 5- 15 parts, 5-15 parts of dried ginger, 7-15 parts of leech, 5-15 parts of Atractylodes macrocephala. The traditional Chinese medicine composition as described in claim 2 is characterized in that it contains the following raw materials in parts by weight: 20 parts of Bupleurum, 15 parts of Citrus aurantii, 10 parts of raw rhubarb, 10 parts of Radix Paeoniae Alba, 10 parts of dried ginger, 10 parts of leech, 10 parts of Atractylodes macrocephala. A traditional Chinese medicine composition, characterized in that it comprises the following raw materials in parts by weight: 5-35 parts of Bupleurum bupleuri, 5-30 parts of Citrus aurantii, 3-20 parts of raw rhubarb, 3-20 parts of white peony root, 3 parts of dried ginger -20 parts, 3-25 parts of leech, 3-20 parts of licorice, 3-20 parts of Atractylodes macrocephala, 3-45 parts of raw oyster. The traditional Chinese medicine composition as described in claim 4 is characterized in that it comprises the following raw materials in parts by weight: 15-30 parts of Bupleurum, 10-20 parts of Citrus aurantium, 5-15 parts of raw rhubarb, 5-5 parts of white peony 15 parts, 5-15 parts of dried ginger, 7-15 parts of leeches, 5-15 parts of licorice, 5-15 parts of Atractylodes macrocephala, 10-35 parts of raw oysters. The traditional Chinese medicine composition as described in claim 5 is characterized in that it contains the following raw materials in parts by weight: 20 parts of Bupleurum, 15 parts of Citrus aurantium, 10 parts of raw rhubarb, 10 parts of Radix Paeoniae Alba, 10 parts of dried ginger, 10 parts of leeches, 10 parts of licorice, 10 parts of Atractylodes macrocephala, 30 parts of raw oysters. A traditional Chinese medicine composition, characterized in that it includes the following raw materials in parts by weight: 5-35 parts of Bupleurum, 5-30 parts of Citrus aurantii, 3-20 parts of raw rhubarb, 1-20 parts of Scutellaria baicalensis, 3-3 parts of white peony 20 parts, 3-20 parts of dried ginger, 3-25 parts of leech, 3-20 parts of licorice, 3-20 parts of Codonopsis pilosula, 3-20 parts of Atractylodes macrocephala, 3-45 parts of raw oyster. The traditional Chinese medicine composition as claimed in claim 7, is characterized in that it contains the following raw materials in parts by weight: 15-30 parts of Bupleurum, 10-20 parts of Citrus aurantium, 5-15 parts of raw rhubarb, 2-10 parts of Scutellaria baicalensis 5-15 parts of Radix Paeoniae Alba, 5-15 parts of Dried Ginger, 7-15 parts of Leech, 5-15 parts of Licorice, 5-15 parts of Codonopsis, 5-15 parts of Atractylodes Rhizome, 10-35 parts of Raw Oyster. The traditional Chinese medicine composition as described in claim 8 is characterized in that it contains the following raw materials in parts by weight: 20 parts of Bupleurum, 15 parts of Citrus aurantii, 10 parts of raw rhubarb, 3 parts of Scutellaria baicalensis, 10 parts of Radix Paeoniae Alba, dried 10 parts of ginger, 10 parts of leeches, 10 parts of licorice, 10 parts of Codonopsis pilosula, 10 parts of Atractylodes macrocephala, 30 parts of raw oysters. A traditional Chinese medicine composition, characterized in that it comprises the following raw materials in parts by weight: 3-20 parts of raw rhubarb, 3-20 parts of dried ginger, 3-20 parts of white peony root, 3-25 parts of leech, and 3-20 parts of licorice 3-45 parts of raw oysters, 3-20 parts of paeonol, 2-15 parts of peach kernels. The traditional Chinese medicine composition as described in claim item 10 is characterized in that it comprises the following raw materials in parts by weight: 5-15 parts of raw rhubarb, 5-15 parts of dried ginger, 5-15 parts of paeonol, 3-12 parts of peach kernel 5-15 parts of Radix Paeoniae Alba, 7-15 parts of leeches, 5-15 parts of licorice, 10-35 parts of raw oysters. The traditional Chinese medicine composition as described in claim 11 is characterized in that it contains the following raw materials in parts by weight: 10 parts of raw rhubarb, 10 parts of dried ginger, 10 parts of white peony root, 10 parts of leech, 10 parts of licorice, raw oyster 30 parts, Danpi 10 parts, peach kernel 6 parts. The traditional Chinese medicine composition as described in any one of claims 1-12 is characterized in that it is an oral preparation. The traditional Chinese medicine composition as claimed in item 13 is characterized in that it is decoction, granule, lozenge or capsule. Application of the traditional Chinese medicine composition as described in any one of claims 1-12 in the preparation of medicines for preventing or controlling the formation of atherosclerotic plaque. Application of the traditional Chinese medicine composition as described in any one of claims 1-12 in the preparation of medicines for preventing or treating atherosclerotic plaque. Application of the traditional Chinese medicine composition as described in any one of claims 1-12 in the preparation of medicaments for preventing or treating atherosclerotic ischemic heart and brain diseases. Application of the traditional Chinese medicine composition as described in any one of claim items 1-12 in the preparation of a medicament for preventing or treating elevated blood lipids. Application of the traditional Chinese medicine composition as described in any one of claims 1-12 in the preparation of a medicament for preventing or treating elevated triglycerides. Application of the traditional Chinese medicine composition as described in any one of claims 1-12 in the preparation of a medicament for preventing or treating elevated cholesterol. Application of the traditional Chinese medicine composition as described in any one of claims 1-12 in the preparation of a medicament for preventing or treating hyperlipidemia. Application of the traditional Chinese medicine composition as described in any one of claims 1-12 in the preparation of medicines for preventing or treating chronic metabolic diseases.

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