Traditional Chinese medicine composition for treating atherosclerosis

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating atherosclerosis. The application finds that the core pathogenesis of AS is yang deficiency, phlegm coagulation, qi depression and blood stasis, the AS is treated by activating yang, promoting the circulation of qi, reducing phlegm and dredging collaterals, and the traditional Chinese medicine composition is prepared by adding or reducing snakegourd fruit and immature bitter orange decoction and immature bitter orange, allium macrostemon and cassia twig decoction. When the traditional Chinese medicine is singly used, the symptoms of oppression, dizziness, profuse phlegm and the like of patients with atherosclerotic plaque formation and dyslipidemia can be improved in a short time, and the traditional Chinese medicine has the effects of lowering lipid and stabilizing plaque after long-term treatment; when the traditional Chinese medicine composition is combined with atorvastatin tablets for use, the traditional Chinese medicine composition has obvious effects of lowering lipid, improving symptoms and reducing inflammatory factors on atherosclerotic patients with yang deficiency, phlegm coagulation, qi deficiency and blood stasis syndromes. The traditional Chinese medicine composition has certain safety in clinical application regardless of a single traditional Chinese medicine formula or the combination of the traditional Chinese medicine composition and atorvastatin tablets.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating atherosclerosis. Background Art

[0002] Atherosclerosis (AS) is a chronic progressive inflammatory disease of the arterial wall that can lead to cardiovascular and cerebrovascular diseases such as coronary heart disease, stroke, and myocardial infarction (VALLEJO J, COCHAIN ​​C, ZERNECKE A, et al. Heterogeneity of immune cells in human atherosclerosis revealed by scRNA-Seq[J]. Cardiovasc Res, 2021, 117(13): 2537-2543.). Carotid artery atherosclerosis (CAS) is a local manifestation of systemic atherosclerosis, and its mechanism is similar to that of coronary and cerebral atherosclerosis. Lipid metabolism disorders and inflammation are the main pathogenic basis of AS. Improving lipid metabolism and controlling inflammation have a positive effect on the treatment of AS (FREDMAN G, MACNAMARA KC. Atherosclerosis is a major human killer and non-resolving inflammation is a prime suspect [J]. Cardiovasc Res, 2021, 117 (13): 2563-2574.). AS risk factors are divided into unchangeable risk factors and modifiable risk factors. Modifiable risk factors include unreasonable diet structure, unhealthy lifestyle, certain diseases, etc. Unreasonable diet structure, high-fat and high-cholesterol diet will accelerate the occurrence of AS, and unhealthy lifestyles such as smoking and drinking are two major risk factors for AS.

[0003] At present, most scholars believe that the formation of atherosclerosis is closely related to inflammatory response. When atherosclerotic plaques erode or rupture, multiple inflammatory mechanisms are involved, including extracellular matrix degradation, leukocyte migration, platelet activation, and endothelial dysfunction. A large number of inflammatory factors are secreted during the above-mentioned inflammatory process, and the common ones are TNF, IL-6, IL-1β, etc. The release of a large number of inflammatory factors triggers the active metabolism of macrophages, and macrophages continuously engulf a large amount of oxidized low-density lipoprotein, eventually forming atherosclerotic plaques. The release of inflammatory factors and the activity of macrophages increase the instability and complexity of atherosclerotic plaques (Thank you, Ding Yanbing, Chen Xiaomin. Mechanism of action of Buyang Huanwu Decoction against atherosclerosis [J]. Shizhen Traditional Chinese Medicine, 2024, 35(01): 93-96.). The pathogenesis of AS mainly includes the lipid infiltration theory, the endothelial injury-reaction theory, the platelet aggregation and thrombosis hypothesis, and the smooth muscle cell cloning theory (Li Baoliu. Mechanism of action of Danggui Buxue Decoction in protecting vascular endothelium and improving shear force combined with high-fat AS rabbit model [D]. Guangzhou University of Chinese Medicine, 2018.). In the initial stage of AS, local blood flow disturbance in the artery leads to intimal rupture, affecting endothelial cell function, LDL-C deposition in the arterial intima, and stimulating inflammatory response; in the progressive stage of AS, smooth muscle cells migrate and proliferate to the intima, while smooth muscle cells, macrophages, and T lymphocytes may undergo cell death and apoptosis, forming the necrotic core of AS plaques. In the complex stage of AS, AS plaques have calcium salt deposition, and the rupture of unstable AS plaques triggers local thrombosis. Persistent and occlusive thrombi can cause ischemic injuries, such as acute coronary syndrome and stroke.

[0004] The treatment of AS is currently based on Western medicine, including lipid regulation, antiplatelet therapy, anticoagulation and thrombolysis, vasodilation, antioxidant therapy, anti-inflammatory therapy, etc. For patients with severe atherosclerosis, surgical methods including endarterectomy, angioplasty and stent implantation, and arterial stenting are often used. At present, Western medicine is still based on statins as lipid-regulating and plaque-stabilizing drugs, but there are often cases where statins alone cannot achieve the expected lipid regulation effect, and there are "6% effect of statin efficacy", adverse reactions of statins such as abnormal liver function, related muscle complications, new diabetes and other adverse reactions. In recent years, research on the prevention and treatment of atherosclerosis and plaque rupture with traditional Chinese medicine has made certain breakthroughs. Traditional Chinese medicine has a variety of natural active ingredients, and has the characteristics of multi-target and multi-link intervention in the occurrence and development of AS, and is low in price, which is worth in-depth research. AS is classified as "stasis syndrome" and "phlegm syndrome" in traditional Chinese medicine. Qi and blood deficiency and the combination of phlegm and blood stasis are its key pathogenesis. Invigorating qi and activating blood circulation can treat the root cause, while unblocking meridians and removing blood stasis can treat the symptoms. They can effectively treat AS (Huang Nianping, Xiang Jianjun, Huang Xinquan, et al. Observation on the efficacy of Jiangzhi Huoxue Tablets combined with Rosuvastatin Calcium Tablets in the treatment of symptomatic intracranial artery atherosclerotic stenosis [J]. Journal of Integrated Traditional Chinese and Western Medicine for Cardiovascular and Cerebrovascular Diseases, 2020, 18(6): 976-979.). Summary of the invention

[0005] The inventor of the present application found in clinical practice that the core pathogenesis of AS is Yang deficiency and phlegm stagnation, Qi stagnation and blood stasis syndrome, and the treatment is to promote Yang and Qi, resolve phlegm and dredge collaterals, prescribe Gualou Zhishi decoction combined with Zhishi Xiebai Guizhi decoction with modifications, and use this prescription in combination with atorvastatin tablets, which has a significant effect of lowering lipids and improving TCM syndromes in patients with Yang deficiency and phlegm stagnation, Qi deficiency and blood stasis syndrome of atherosclerosis. Based on this, the present invention was completed.

[0006] In a first aspect, the present invention provides a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition is made of the following traditional Chinese medicines in parts by weight:

[0007] The main drug is selected from one or more of 20-100 parts of raw astragalus and / or 5-50 parts of aconite;

[0008] The ministerial drug is selected from one or more of 10-50 parts of Trichosanthes peel, 5-50 parts of Curcuma zedoariae, 10-50 parts of Salvia miltiorrhizae and / or 5-50 parts of Rhodiola rosea;

[0009] The adjuvant is selected from one or more of 5-50 parts of Chuanxiong, 10-40 parts of Xiebai, 5-30 parts of Zhishi, 15-50 parts of Puerariae, 10-80 parts of Poria, 5-50 parts of Pinellia and / or 5-40 parts of Curcuma;

[0010] The adjuvant drug is selected from one or more of 5-20 parts of licorice root and / or 10-50 parts of cassia twig.

[0011] Preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight:

[0012] The main drug is selected from one or more of 20-60 parts of raw astragalus and / or 10-30 parts of aconite;

[0013] The ministerial drug is selected from one or more of 15-30 parts of Trichosanthes peel, 10-30 parts of Curcuma zedoariae, 15-30 parts of Salvia miltiorrhizae and / or 10-40 parts of Rhodiola rosea;

[0014] The adjuvant is selected from one or more of 15-40 parts of Chuanxiong, 15-40 parts of Xiebai, 15-30 parts of Zhishi, 20-40 parts of Puerariae, 20-60 parts of Poria, 6-30 parts of Pinellia and / or 10-30 parts of Curcuma;

[0015] The adjuvant drug is selected from one or more of 6-15 parts of roasted liquorice root and / or 10-30 parts of cassia twig.

[0016] More preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight:

[0017] The main drug is selected from one or more of 30-50 parts of raw astragalus and / or 10-20 parts of aconite;

[0018] The ministerial drug is selected from one or more of 20-30 parts of Trichosanthes peel, 15-30 parts of Curcuma zedoariae, 15-20 parts of Salvia miltiorrhizae and / or 15-30 parts of Rhodiola rosea;

[0019] The adjuvant is selected from one or more of 15-30 parts of Chuanxiong, 15-30 parts of Xiebai, 15-20 parts of Zhishi, 20-35 parts of Puerariae, 20-35 parts of Poria, 9-20 parts of Pinellia and / or 12-15 parts of Curcuma;

[0020] The adjuvant drug is selected from one or more of 6-10 parts of Radix Glycyrrhizae and / or 10-25 parts of Cassia Twig.

[0021] In one embodiment of the present invention, the traditional Chinese medicine composition is composed of 20-100 parts of raw astragalus, 5-50 parts of aconite, 10-50 parts of trichosanthes peel, 5-50 parts of curcuma, 10-50 parts of salvia miltiorrhiza, 5-50 parts of rhodiola rosea, 5-50 parts of chuanxiong, 10-40 parts of xiebai, 5-30 parts of citrus aurantium, 15-50 parts of kudzu root, 10-80 parts of poria, 5-20 parts of roasted licorice, and 10-50 parts of cassia twig.

[0022] Preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight: 20-60 parts of raw astragalus, 10-30 parts of aconite, 15-30 parts of trichosanthes peel, 10-30 parts of curcuma, 15-30 parts of salvia miltiorrhiza, 10-40 parts of rhodiola rosea, 15-40 parts of chuanxiong, 15-40 parts of allium macrostemon, 15-30 parts of immature bitter orange, 20-40 parts of kudzu root, 20-60 parts of poria, 6-15 parts of roasted licorice, and 10-30 parts of cassia twig.

[0023] More preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight: 30-50 parts of raw astragalus, 10-20 parts of aconite, 20-30 parts of trichosanthes peel, 15-30 parts of curcuma, 15-20 parts of salvia miltiorrhiza, 15-30 parts of rhodiola rosea, 15-30 parts of ligusticum chuanxiong, 15-30 parts of allium macrostemon, 15-20 parts of immature bitter orange, 20-35 parts of kudzu root, 20-35 parts of poria, 6-10 parts of roasted licorice, and 10-25 parts of cassia twig.

[0024] In one embodiment of the present invention, the traditional Chinese medicine composition is composed of 20-100 parts of raw astragalus, 5-50 parts of aconite, 10-50 parts of trichosanthes peel, 5-50 parts of curcuma, 10-50 parts of salvia miltiorrhiza, 5-50 parts of rhodiola rosea, 5-50 parts of chuanxiong, 10-40 parts of xiebai, 5-30 parts of citrus aurantium, 15-50 parts of kudzu root, 10-80 parts of poria, 5-50 parts of pinellia, 5-20 parts of roasted licorice, and 10-50 parts of cassia twig.

[0025] Preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight: 20-60 parts of raw astragalus, 10-30 parts of aconite, 15-30 parts of trichosanthes peel, 10-30 parts of curcuma, 15-30 parts of salvia miltiorrhiza, 10-40 parts of rhodiola rosea, 15-40 parts of chuanxiong, 15-40 parts of ximboses, 15-30 parts of immature bitter orange, 20-40 parts of kudzu root, 20-60 parts of poria, 6-30 parts of pinellia, 6-15 parts of roasted licorice, and 10-30 parts of cassia twig.

[0026] More preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight: 30-50 parts of raw astragalus, 10-20 parts of aconite, 20-30 parts of trichosanthes peel, 15-30 parts of curcuma, 15-20 parts of salvia miltiorrhiza, 15-30 parts of rhodiola rosea, 15-30 parts of ligusticum chuanxiong, 15-30 parts of allium macrostemon, 15-20 parts of immature bitter orange, 20-35 parts of kudzu root, 20-35 parts of poria, 9-20 parts of pinellia, 6-10 parts of roasted licorice, and 10-25 parts of cassia twig.

[0027] In one embodiment of the present invention, the traditional Chinese medicine composition is composed of 20-100 parts of raw astragalus, 5-50 parts of aconite, 10-50 parts of trichosanthes peel, 5-50 parts of curcuma, 10-50 parts of salvia miltiorrhiza, 5-50 parts of rhodiola rosea, 5-50 parts of chuanxiong, 10-40 parts of xiebai, 5-30 parts of citrus aurantium, 15-50 parts of kudzu root, 10-80 parts of poria, 5-40 parts of curcuma, 5-20 parts of roasted licorice, and 10-50 parts of cassia twig.

[0028] Preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight: 20-60 parts of raw astragalus, 10-30 parts of aconite, 15-30 parts of trichosanthes peel, 10-30 parts of curcuma, 15-30 parts of salvia miltiorrhiza, 10-40 parts of rhodiola rosea, 15-40 parts of chuanxiong, 15-40 parts of ximboses, 15-30 parts of immature bitter orange, 20-40 parts of kudzu root, 20-60 parts of poria, 10-30 parts of curcuma, 6-15 parts of roasted licorice, and 10-30 parts of cassia twig.

[0029] More preferably, the Chinese medicine composition is made of the following Chinese medicines in parts by weight: 30-50 parts of raw astragalus, 10-20 parts of aconite, 20-30 parts of trichosanthes peel, 15-30 parts of curcuma, 15-20 parts of salvia miltiorrhiza, 15-30 parts of rhodiola rosea, 15-30 parts of chuanxiong, 15-30 parts of allium macrostemon, 15-20 parts of immature bitter orange, 20-35 parts of kudzu root, 20-35 parts of poria, 12-15 parts of curcuma, 6-10 parts of roasted licorice, and 10-25 parts of cassia twig.

[0030] In a second aspect, the present invention provides a Chinese medicine preparation made from the Chinese medicine composition described in the first aspect.

[0031] Furthermore, the Chinese medicine preparation is one or more of paste prescriptions, pills, pills, decoctions, granules, capsules, powders and / or tablets.

[0032] Furthermore, the traditional Chinese medicine preparation contains pharmaceutically acceptable excipients required for the corresponding preparation.

[0033] Furthermore, the excipient is a pharmaceutical excipient that enhances the efficacy, reduces toxicity and / or alleviates side effects of the main drug.

[0034] In a third aspect, the present invention provides use of the traditional Chinese medicine composition described in the first aspect in preparing a drug for treating atherosclerosis.

[0035] Furthermore, the pharmaceutical dosage form includes, but is not limited to, one or more of ointments, pills, pills, decoctions, granules, capsules, powders and / or tablets.

[0036] Furthermore, the atherosclerosis refers to atherosclerosis of Yang deficiency, phlegm stagnation, Qi stagnation and blood stasis syndrome.

[0037] The medicinal properties and effects of each Chinese medicinal material in the present invention are as follows:

[0038] Raw Astragalus: sweet, slightly warm. Enters the lung and spleen meridians. It has the effects of replenishing qi and raising yang, promoting body fluid and nourishing blood, relieving stagnation and relieving numbness, consolidating the exterior and stopping sweating, and promoting diuresis and reducing swelling. It is used for qi deficiency and fatigue, blood deficiency and stasis, arthralgia and numbness, poor appetite and loose stools, sinking of middle qi, spontaneous sweating due to exterior deficiency, and edema due to qi deficiency.

[0039] Aconite: Spicy and sweet, hot in nature, toxic. Enters the heart, spleen, and kidney meridians. Has the effects of replenishing fire and yang, dispelling cold and dampness, and breaking up hard masses. Treats yang deficiency and cold stagnation, cold and dampness, and all diseases of deep cold and chronic cold.

[0040] Pueraria root: sweet, spicy, cool in nature. Enters the spleen, stomach, and lung meridians. It has the effects of raising yang and stopping diarrhea, promoting blood circulation and activating collaterals, promoting body fluid and quenching thirst, relieving muscles and reducing fever. It is used for dizziness and headache, hemiplegia caused by stroke, chest pain, stiff neck and back pain, thirst, diarrhea, and exogenous fever and headache.

[0041] Poria: sweet, light, neutral in nature. Enters the heart, lung, spleen, and kidney meridians. Has the effects of promoting diuresis and removing dampness, strengthening the spleen, and calming the mind. Used for edema, oliguria, phlegm and fluid, palpitations, spleen deficiency, poor appetite, loose stools, restlessness, palpitations, and insomnia.

[0042] Gualou Pi: sweet in taste, cold in nature. Enters the lung and stomach meridians. Has the effects of clearing away heat and resolving phlegm, promoting qi and relieving chest tightness. Used for cough due to phlegm-heat, chest tightness and flank pain.

[0043] Cinnamon twig: pungent, sweet, warm in nature. Enters the heart, lung, and bladder meridians. Has the effects of sweating and relieving muscles, warming and unblocking the meridians, assisting yang and transforming qi, and balancing and descending qi. Used for colds, cold pain in the abdomen, amenorrhea due to cold blood, joint pain, phlegm and fluid retention, edema, palpitations, and running pig.

[0044] Xiebai: Spicy and bitter in taste, warm in nature. Enters the heart, lung, stomach and large intestine meridians. Has the effects of promoting yang and dispersing stagnation, promoting qi and removing stagnation. Used for chest pain, abdominal distension and pain, and heaviness after diarrhea.

[0045] Citrus aurantium: bitter, pungent, sour, slightly cold. Enters the spleen and stomach meridians. Has the effects of breaking up qi and eliminating stagnation, resolving phlegm and dispersing lumps. Used for stagnation of internal stagnation, fullness and pain, heaviness after diarrhea, constipation, phlegm stagnation and qi obstruction, chest pain, chest congestion, and sagging of internal organs.

[0046] Danshen: bitter, slightly cold. Enters the heart and liver meridians. Has the effects of promoting blood circulation and removing blood stasis, relieving pain, clearing the heart and relieving vexation, cooling blood and eliminating carbuncle. Used for chest pain, abdominal pain, accumulation of masses, pain due to heat, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, and sores and swelling.

[0047] Chuanxiong: spicy, warm in nature. Enters the liver, gallbladder, and pericardium meridians. Has the effects of promoting blood circulation and qi, dispelling wind and relieving pain. Used for chest pain, chest and flank pain, swelling and pain from falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to lumps, headache, and rheumatic pain.

[0048] Rhodiola rosea: sweet, bitter, neutral in nature. Enters the lung and heart meridians. Has the effects of invigorating qi and activating blood circulation, unblocking meridians and relieving asthma. Used for qi deficiency and blood stasis, chest pain, hemiplegia due to stroke, fatigue and asthma.

[0049] Curcuma: Spicy, bitter, warm in nature. Enters the liver and spleen meridians. Has the effects of promoting qi and removing blood, eliminating accumulation and relieving pain. Used for lumps and masses, blood stasis and amenorrhea, chest pain and heartache, and distension and pain caused by food accumulation.

[0050] Roasted Licorice: Sweet in taste, neutral in nature. Enters the heart, lung, spleen, and stomach meridians. Has the effects of tonifying the spleen and stomach, replenishing qi and restoring pulse. Used for spleen and stomach weakness, fatigue, palpitations, and irregular pulse.

[0051] French Pinellia: Spicy, warm in nature. Enters the spleen, stomach, and lung meridians. Has the effect of drying dampness and resolving phlegm. Used for cough and asthma due to excessive phlegm, dizziness and palpitations due to phlegm, dizziness due to wind phlegm, and headache due to phlegm syncope.

[0052] Curcuma: pungent, bitter, cold in nature. Enters the liver, heart, and lung meridians. Has the effects of promoting blood circulation and relieving pain, promoting qi and relieving depression, clearing the heart and cooling blood, promoting bile and relieving jaundice. Used for chest and flank pain, chest obstruction and heart pain, amenorrhea and dysmenorrhea, breast pain, febrile coma, epilepsy, vomiting and bleeding due to blood heat, jaundice and red urine.

[0053] The treatment principle of the present invention is:

[0054] This disease is manifested as deficiency of the root and excess of the superficial symptoms. The essence of the disease is yang deficiency and phlegm stagnation, qi deficiency and blood stasis. Phlegm, dampness, stasis, heat, and toxicity are both pathological products and pathogenic factors. Evil qi blocks the meridians and sticks to the blood vessels, forming masses, gathering and not dispersing. Long-term illness enters the meridians, the meridians are blocked, and the meridians are accumulated, which eventually leads to meridian syndrome accumulation, making qi, blood, yin and yang more deficient, aggravating the damage of the meridians and accelerating the process of AS. Gualou Zhishi Decoction combined with Zhishi Xiebai Guizhi Decoction has the effect of promoting yang and qi, resolving phlegm and unblocking the meridians.

[0055] In the Chinese medicine formula of this application, aconite replenishes fire and promotes yang, dispels cold and removes dampness; astragalus replenishes qi and promotes diuresis, and the two medicines are the main medicines of this prescription. Trichosanthes is both a phlegm-resolving medicine and a qi-promoting medicine, and a dryness-moistening medicine; Curcuma promotes qi and blood circulation, promotes blood circulation and dissipates blood stasis, eliminates accumulation and relieves pain; Salvia miltiorrhiza removes blood stasis and relieves pain, promotes blood circulation and menstruation, clears the heart and relieves restlessness; Rhodiola rosea replenishes qi and clears the lungs, improves intelligence and nourishes the heart, and the above are ministerial medicines. Chuanxiong promotes blood circulation and qi circulation, dispels wind and relieves pain; Xiebai is both a yang-promoting medicine and a qi-promoting medicine; Zhishi is both a qi-promoting medicine and a dampness-removing medicine; Pueraria root raises yang and relieves restlessness; Poria strengthens the spleen and replenishes qi; the above five flavors are adjuvants. Roasted licorice is mainly used for harmonization and detoxification of various medicines; cinnamon twig is both a yang-promoting medicine and a blood-removing medicine; the two medicines are guiding medicines. For those with obvious phlegm and dampness, and stagnation in the chest, add Pinellia ternata; for those with qi stagnation and blood stasis, and obvious pain, add Curcuma.

[0056] Beneficial Effects

[0057] 1. This application uses traditional Chinese medicine alone to treat patients with atherosclerotic plaque formation and abnormal lipid metabolism, and has a significant effect on improving symptoms such as stuffiness, dizziness, and sputum in the short term; long-term traditional Chinese medicine treatment has the effect of lowering lipids and stabilizing plaques.

[0058] 2. The combined use of the present application formulation and atorvastatin tablets has a significant effect of lowering blood lipids and improving symptoms in patients with yang deficiency, phlegm stagnation, qi deficiency and blood stasis syndrome of atherosclerosis type, and can also reduce inflammatory factors in patients with yang deficiency, phlegm stagnation, qi deficiency and blood stasis syndrome of atherosclerosis type.

[0059] 3. Whether the Chinese medicine in this application is used alone or in combination with atorvastatin tablets, no abnormal liver and kidney function and adverse reactions were observed in the patients during the treatment process, and it is safe in clinical application. DETAILED DESCRIPTION

[0060] The specific embodiments of the present invention are further described below. It should be noted that the description of these embodiments is used to help understand the present invention, but does not constitute a limitation of the present invention. In addition, the technical features involved in the embodiments described below can be combined with each other as long as they do not conflict with each other.

[0061] The experimental methods in the following examples are conventional methods unless otherwise specified, and the experimental materials used in the following examples are commercially available unless otherwise specified.

[0062] Explanation of terms

[0063] Total cholesterol (TC): refers to the sum of cholesterol contained in various lipoproteins in the blood. When TC alone is elevated, it can be diagnosed as hypercholesterolemia, and statins are the first choice for clinical treatment. TC levels have a predictive effect on the risk of ASCVD. The appropriate level of TC is <5.2mmol / L, ≥5.2 and <6.2mmol / L are at the borderline level, and ≥6.2mmol / L is elevated.

[0064] Triglyceride (TG): When TG alone is elevated, it can be diagnosed as hypertriglyceridemia. If it is mildly elevated, you can first control your diet, increase exercise, etc. If it is still elevated, fibrates are the first choice for treatment. When TC and TG are elevated at the same time, it can be diagnosed as mixed hyperlipidemia. The appropriate level of TG is <1.7mmol / L, ≥1.7 and <2.3mmol / L is borderline elevated, and ≥2.3mmol / L is elevated.

[0065] High-density lipoprotein (HDL-C): It is the lipoprotein with the highest density and smallest particles in the blood. High-density lipoprotein is responsible for transporting cholesterol in plaques to the liver for decomposition and metabolism, that is, reverse cholesterol transport, reducing the deposition of cholesterol in the blood vessel walls and playing an anti-atherosclerotic role. HDL-C <1.0mmol / L is considered low. A decrease in HDL-C alone can be diagnosed as low HDL-C blood, but clinically, there are few cases of HDL-C alone being reduced. If the patient's HDL-C is reduced, it means a decrease in reverse transcribed cholesterol, which indicates an increased risk of cardiovascular disease, and medication adjustments need to be made in combination with other blood lipid results.

[0066] Low-density lipoprotein (LDL-C): Increased levels are the main risk factor for the occurrence and development of atherosclerosis. LDL-C is responsible for transporting cholesterol from the liver to plaques, increasing the risk of ASCVD. Generally, LDL-C is parallel to TC, but TC levels are also affected by HDL-C levels. Therefore, LDL-C can better assess the risk of ASCVD. Lowering LDL-C levels is one of the important strategies for preventing and treating ASCVD, and is also the primary goal of preventing and treating dyslipidemia.

[0067] C-reactive protein (CRP): refers to the fact that when the body is subjected to trauma, burns, inflammatory stimulation, myocardial infarction, acute infection, etc., the levels of some proteins in the plasma will increase or decrease significantly. This physiological phenomenon is called acute phase reaction. The corresponding group of changed proteins is what we often call acute phase reaction protein. C-reactive protein is one of the many acute phase reaction proteins. It is often used in clinical practice to assess the severity of infection and monitor the effectiveness of treatment.

[0068] Homocysteine ​​(HCY): It is a sulfur-containing amino acid formed after the demethylation of methionine. It can not only cause damage to vascular endothelial cells, but also has the role of pro-inflammatory factors and immunomodulatory factors, and participates in inducing inflammation and autoimmune reactions in the body. Under normal circumstances, homocysteine ​​can be decomposed and metabolized by our body and maintained at 0-15μmol / L in the blood. Therefore, when homocysteine ​​in the blood is ≥15μmol / L, it is hyperhomocysteinemia.

[0069] Example 1 Clinical Study 1

[0070] 1. Materials and methods

[0071] 1.1 Case source

[0072] From January 1, 2023 to March 1, 2024, 70 patients with atherosclerosis with yang deficiency, phlegm stagnation, qi stagnation and blood stasis syndrome admitted to the outpatient department of internal medicine of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University were enrolled.

[0073] 1.2 Diagnostic criteria

[0074] 1.2.1 Western medicine diagnostic criteria

[0075] Refer to the "Guidelines for Ultrasound Examination of Vascular and Superficial Organs" and the "Consensus on the Diagnosis and Treatment of Head and Neck Atherosclerosis in China":

[0076] (1) The thickness from the inner surface of the arterial intima to the medial smooth muscle is ≥1.0 mm, which is considered as intima-media thickening;

[0077] (2) Lesions that are more prominent than the surface of the intima are detected in the arterial intima, and their vertical distance is measured. A lesion ≥1.5 mm is considered a plaque.

[0078] 1.2.2 TCM diagnostic criteria

[0079] With reference to Traditional Chinese Medicine Internal Medicine and Expert Consensus on Prevention and Treatment of Atherosclerosis with Traditional Chinese and Western Medicine and combined with clinical practice, diagnostic criteria for TCM syndromes of Yang deficiency and phlegm stagnation, and Qi stagnation and blood stasis were formulated.

[0080] Main symptoms: fatigue, aversion to cold, cold hands and feet, heaviness in the head, headache, abdominal distension, loose stools, and obesity.

[0081] Secondary symptoms: forgetfulness, heaviness in limbs, shortness of breath, laziness to speak, palpitations and insomnia, tasteless mouth, thirst without desire to drink.

[0082] Tongue and pulse: The tongue is fat and dark or has teeth marks on the edges, with visible ecchymosis, greasy tongue coating, and the pulse is stringy, smooth, fine, or slippery and rapid.

[0083] If the patient meets the above three main symptoms and two minor symptoms and combined with the tongue coating, it can be diagnosed as: Yang deficiency and phlegm stagnation, Qi stagnation and blood stasis syndrome.

[0084] 1.3 Inclusion criteria

[0085] (1) Meet the diagnostic criteria;

[0086] (2) Aged 18 to 79 years old;

[0087] (3) Meet the diagnostic criteria for hyperlipidemia in the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese Adults (2016 Revised Edition);

[0088] (4) The patient's basic information is complete, he or she can take medication consistently and is eligible for follow-up;

[0089] (5) The patients understood this study and signed the informed consent.

[0090] 1.4 Exclusion criteria

[0091] (1) Abnormal liver function;

[0092] (2) Allergic to the study drugs;

[0093] (3) Acute cardiovascular and cerebrovascular diseases;

[0094] (4) those who have had major trauma or surgery;

[0095] (5) Patients with acute infectious diseases, autoimmune diseases, or severe cardiopulmonary insufficiency.

[0096] 1.5 General Information

[0097] The patients were randomly divided into a control group and an experimental group, with 35 cases in each group. During the follow-up, 5 cases dropped out of the control group and 2 cases dropped out of the experimental group. Finally, 30 cases were included in the control group and 33 cases in the experimental group. The age and gender comparison between the two groups is shown in Table 1-2. There was no statistical difference in gender and age between the two groups, and they were comparable (P>0.05).

[0098] Table 1 Comparison of age between the two groups of patients

[0099]

[0100] 2. Methods

[0101] 2.1 Treatment options

[0102] 2.1.1 Basic solution

[0103] Both groups received diet and exercise guidance, and were advised to quit smoking and drinking, control their weight in a healthy way, and eat a reasonable diet according to different situations.

[0104] 2.1.2 Trial Grouping

[0105] Control group: Atorvastatin calcium tablets (Lipitor).

[0106] Experimental group: Gualou Zhishi decoction combined with Zhishi Xiebai Guizhi decoction combined with atorvastatin tablets (Lipitor).

[0107] Gua Lou Zhi Shi Tang combined with Zhi Shi Xie Bai Gui Zhi Tang: Raw Astragalus 30g, Pueraria lobata 30g, Aconitum 9g, Poria 30g, Trichosanthes peel 20g, Cassia twig 20g, Xie Bai 20g, Zhi Shi 15g, Salvia miltiorrhiza 30g, Ligusticum chuanxiong 15g, Rhodiola rosea 15g, Curcuma 15g, and roasted Licorice root 9g.

[0108] 2.1.3 Usage and Dosage

[0109] Take one dose of Chinese medicine twice a day, once in the morning and once in the evening (200ml), and take it warm half an hour after meals;

[0110] Western medicine was taken once a night, 20 mg each time, before bedtime. Treatment lasted for 12 weeks.

[0111] 2.2 Observation indicators

[0112] 2.2.1 Blood lipid index

[0113] Total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL-C), and low-density lipoprotein (LDL-C) levels.

[0114] 2.2.2 Inflammatory indicators

[0115] C-reactive protein (CRP), homocysteine ​​(HCY).

[0116] 2.2.3 TCM Syndrome Score

[0117] Except for body obesity, the main symptoms are divided into four levels: "none, mild, moderate, and severe", with 0 points, 2 points, 4 points, and 6 points respectively; "body obesity" is scored according to the BMI (body mass index) numerical range, with a normal range of 0 points, >25 for 2 points, >30 for 4 points, and >35 for 6 points. Record once before and after treatment.

[0118] 2.2.4 Safety indicators

[0119] Liver function [alanine aminotransferase (ALT), aspartate aminotransferase (AST)], white blood cell count (WBC), and platelet (PLT) values ​​of all enrolled patients during treatment were recorded, and all adverse events were recorded.

[0120] 2.3 Statistical analysis

[0121] SPSS 26.0 was used for data analysis. Two-sided test was used for overall data analysis, with α set at 0.05 and P < 0.05 considered statistically significant. Count data were expressed as frequency or percentage, and Fisher's exact test or X-ray diffraction analysis was used. 2 Test method. The measurement data were in accordance with normal distribution and had equal variance, and the T test was used. The mean ± standard deviation was used. The nonparametric test method was used to test the data, and the median and 25% and 75% quantiles [M, (P 25 , P 75 )]express.

[0122] 3 Results

[0123] 3.1 Comparison of blood lipid indexes between the two groups before and after treatment

[0124] As shown in Table 3, before treatment, there was no significant difference in the blood lipid indexes (TC, TG, HDL, LDL) between the two groups (P>0.05). After treatment, HDL in the control combined with Chinese medicine group increased compared with the control group, and TC, TG, and LDL decreased compared with the control group, and the difference was statistically significant (P<0.05).

[0125] Table 3 Comparison of blood lipid indexes between the two groups

[0126]

[0127] 3.2 Comparison of inflammatory indicators between the two groups before and after treatment

[0128] As shown in Table 4, before treatment, there was no significant difference in CRP and HCY between the two groups (P>0.05). After treatment, HCY in the experimental group was lower than that in the statin group, and the difference was statistically significant (P<0.05).

[0129] Table 4 Comparison of inflammatory indicators between the two groups [M,(P25,P75)]

[0130]

[0131] 3.3 Comparison of TCM symptom scores between the two groups before and after treatment

[0132] As shown in Table 5, before treatment, there was no significant difference in the TCM symptom scores between the two groups (P>0.05). After treatment, the TCM symptom scores of the experimental group were significantly lower than those of the statin group, and the difference was statistically significant (P<0.001).

[0133] Table 5 Comparison of TCM symptom scores between the two groups

[0134]

[0135] 3.4 Evaluation of safety indicators in the two groups before and after treatment

[0136] As shown in Table 6-7, there was no significant difference in ALT, AST, WBC and PLT between the two groups before and after treatment (P>0.05), indicating that this prescription is safe in clinical application.

[0137] Table 6 Comparison of liver function between the two groups

[0138]

[0139] Note: ALT and AST of the two groups were compared before and after treatment, P>0.05.

[0140] Table 7 Comparison of WBC and PLT between the two groups

[0141]

[0142] Note: The WBC and PLT of the two groups were compared before and after treatment, P>0.05.

[0143] Example 2 Clinical Study 2

[0144] Based on the results of Chinese and Western medicine in the above trials, the treatment data of patients with atherosclerosis and abnormal lipid metabolism who had received traditional Chinese medicine were retrospectively collected and matched with the above two groups of patients according to age and gender baselines. 13 patients were included in each group, including 9 males and 4 females.

[0145] 1. Treatment plan

[0146] 1.1 Trial Grouping

[0147] Statin group: Atorvastatin calcium tablets (Lipitor).

[0148] Traditional Chinese medicine group: Trichosanthes and Zhishi Decoction combined with Zhishi, Xiebai and Guizhi Decoction with modifications.

[0149] Statins combined with traditional Chinese medicine group: Trichosanthes and Zhishi decoction combined with Zhishi Xiebai Guizhi decoction combined with atorvastatin tablets (Lipitor).

[0150] The Chinese medicine group made additions and subtractions on the basis of the basic prescription: ① For obvious phlegm and dampness, stagnation in the chest, add 5-50g of Pinellia ternata; ② For obvious pain caused by qi stagnation and blood stasis, add 5-40g of Curcuma. The dosage of the medicinal ingredients in clinical practice was adjusted according to the severity of the syndrome and the body weight.

[0151] 1.2 Usage and Dosage

[0152] Take one dose of Chinese medicine twice a day, once in the morning and once in the evening (200ml), and take it warm half an hour after meals;

[0153] Western medicine was taken once a night, 20 mg each time, before bedtime. Treatment lasted for 12 weeks.

[0154] 2. Observation indicators and statistical analysis methods Reference Example 1

[0155] 3. Results

[0156] 3.1 Comparison of age among the three groups of patients

[0157] The three groups of patients were matched according to age and gender. The comparison of age and BMI among the three groups is shown in Table 8. There was no statistical difference in age and BMI among the three groups, which was comparable (P>0.05).

[0158] Table 8 Comparison of age among the three groups of patients

[0159] Statins group Pure Chinese medicine group Statins combined with Chinese medicine group P age 64±6.71 64±8.27 60.38±6.19 0.337 BMI 25.09±1.19 26.12±3.42 25.38±3.46 0.648

[0160] 3.2 Comparison of blood lipid indexes among three groups

[0161] As shown in Table 9, before treatment, there was no significant difference in the three groups in terms of blood lipid indexes (TC, TG, HDL, LDL) (P>0.05). After treatment, the conditions of the three groups of patients improved significantly, with statistically significant differences (P<0.05).

[0162] Table 9 Comparison of blood lipid indexes among three groups [M,(P25,P75)]

[0163]

[0164] Note: Compared with the pure Chinese medicine group, * P<0.05; compared with the statin group, # P<0.05; compared with before treatment, Δ P<0.05.

[0165] 3.3 Comparison of inflammation indicators among the three groups

[0166] As shown in Table 10, before treatment, there were no significant differences in CRP and HCY among the three groups of patients (P>0.05). After treatment, HCY in the three groups decreased compared with that before treatment, and the difference was statistically significant (P<0.05).

[0167] Table 10 Comparison of inflammation indicators among three groups [M, (P25, P75)]

[0168]

[0169] Note: Compared with before treatment, ΔP<0.05.

[0170] 3.4 Comparison of TCM symptom scores

[0171] As shown in Table 11, before treatment, there was no significant difference in the TCM symptom scores of the three groups of patients (P>0.05). After treatment, the TCM symptom scores of the three groups of patients were significantly lower than those before treatment, and the TCM symptom scores of the TCM group and the statin combined with TCM group were significantly lower than those of the statin group alone, with significant statistical differences (P<0.05).

[0172] Table 11 Comparison of TCM symptom scores among three groups

[0173]

[0174]

[0175] Note: Compared with before treatment, ΔP<0.05.

[0176] 3.5 Safety indicators

[0177] As shown in Table 12-13, there was no significant difference in ALT, AST, WBC and PLT between the three groups before and after treatment (P>0.05), indicating that this prescription is safe in clinical application.

[0178] Table 12 Comparison of liver function among three groups [M, (P25, P75)]

[0179]

[0180] Note: Compared with the pure Chinese medicine group, * P<0.05.

[0181] Table 13 Comparison of WBC and PLT among three groups

[0182]

[0183] 4. Conclusion

[0184] Simple Chinese medicine treatment of patients with atherosclerotic plaque formation and abnormal lipid metabolism has a significant effect on improving symptoms such as stuffiness, dizziness, and sputum in the short term. The combined use of this prescription and atorvastatin tablets has a significant effect on lowering lipids and improving symptoms in patients with yang deficiency and phlegm stagnation, qi deficiency and blood stasis syndrome of atherosclerosis. Traditional Chinese medicine has no obvious adverse reactions and may be beneficial in reducing the side effects of Western medicine. In the follow-up of cases of this disease treated with simple Chinese medicine, it was found that after long-term Chinese medicine treatment, it has important research value in lowering lipids (6-8 months of treatment) and stabilizing plaques (12-24 months), and no abnormal liver and kidney function and adverse reactions were found in patients during long-term Chinese medicine treatment. Atherosclerosis is a chronic progressive disease. Long-term use of this regimen is beneficial in reducing inflammatory factors and stabilizing plaques, and even shrinking plaques, which is worthy of in-depth study.

Claims

1. A Chinese medicine composition, characterized in that: The Chinese medicine composition is made of the following Chinese medicines in parts by weight: The main drug is selected from one or more of 20-100 parts of raw astragalus and / or 5-50 parts of aconite; The ministerial drug is selected from one or more of 10-50 parts of Trichosanthes peel, 5-50 parts of Curcuma zedoariae, 10-50 parts of Salvia miltiorrhizae and / or 5-50 parts of Rhodiola rosea; The adjuvant is selected from one or more of 5-50 parts of Chuanxiong, 10-40 parts of Xiebai, 5-30 parts of Zhishi, 15-50 parts of Puerariae, 10-80 parts of Poria, 5-50 parts of Pinellia and / or 5-40 parts of Curcuma; The adjuvant drug is selected from one or more of 5-20 parts of licorice root and / or 10-50 parts of cassia twig.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is made of the following Chinese medicines in parts by weight: The main drug is selected from one or more of 20-60 parts of raw astragalus and / or 10-30 parts of aconite; The ministerial drug is selected from one or more of 15-30 parts of Trichosanthes peel, 10-30 parts of Curcuma zedoariae, 15-30 parts of Salvia miltiorrhizae and / or 10-40 parts of Rhodiola rosea; The adjuvant is selected from one or more of 15-40 parts of Chuanxiong, 15-40 parts of Xiebai, 15-30 parts of Zhishi, 20-40 parts of Puerariae, 20-60 parts of Poria, 6-30 parts of Pinellia and / or 10-30 parts of Curcuma; The adjuvant drug is selected from one or more of 6-15 parts of roasted liquorice root and / or 10-30 parts of cassia twig.

3. The Chinese medicine composition according to any one of claims 1 or 2, characterized in that: The Chinese medicine composition is made of the following Chinese medicines in parts by weight: The main drug is selected from one or more of 30-50 parts of raw astragalus and / or 10-20 parts of aconite; The ministerial drug is selected from one or more of 20-30 parts of Trichosanthes peel, 15-30 parts of Curcuma zedoariae, 15-20 parts of Salvia miltiorrhizae and / or 15-30 parts of Rhodiola rosea; The adjuvant is selected from one or more of 15-30 parts of Chuanxiong, 15-30 parts of Xiebai, 15-20 parts of Zhishi, 20-35 parts of Puerariae, 20-35 parts of Poria, 9-20 parts of Pinellia and / or 12-15 parts of Curcuma; The adjuvant drug is selected from one or more of 6-10 parts of Radix Glycyrrhizae and / or 10-25 parts of Cassia Twig.

4. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition consists of 20-100 parts of raw astragalus, 5-50 parts of aconite, 10-50 parts of trichosanthes peel, 5-50 parts of zedoaria, 10-50 parts of salvia miltiorrhiza, 5-50 parts of rhodiola rosea, 5-50 parts of chuanxiong, 10-40 parts of ximboses, 5-30 parts of immature bitter orange, 15-50 parts of kudzu root, 10-80 parts of tuckahoe, 5-20 parts of roasted liquorice and 10-50 parts of cassia twig.

5. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition consists of 20-100 parts of raw astragalus, 5-50 parts of aconite, 10-50 parts of trichosanthes peel, 5-50 parts of zedoaria, 10-50 parts of salvia miltiorrhiza, 5-50 parts of rhodiola rosea, 5-50 parts of chuanxiong, 10-40 parts of ximboses, 5-30 parts of immature bitter orange, 15-50 parts of kudzu root, 10-80 parts of poria, 5-50 parts of pinellia, 5-20 parts of roasted liquorice and 10-50 parts of cassia twig.

6. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition consists of 20-100 parts of raw astragalus, 5-50 parts of aconite, 10-50 parts of trichosanthes peel, 5-50 parts of zedoaria, 10-50 parts of salvia miltiorrhiza, 5-50 parts of rhodiola rosea, 5-50 parts of chuanxiong, 10-40 parts of ximboses, 5-30 parts of immature bitter orange, 15-50 parts of kudzu root, 10-80 parts of tuckahoe, 5-40 parts of curcuma, 5-20 parts of roasted liquorice and 10-50 parts of cassia twig.

7. A Chinese medicine preparation made from the Chinese medicine composition according to any one of claims 1 to 6.

8. The Chinese medicine preparation according to claim 7, characterized in that: The Chinese medicine preparation is one or more of paste prescriptions, pills, pills, decoctions, granules, capsules, powders and / or tablets.

9. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for treating atherosclerosis.

10. The use according to claim 9, characterized in that: The atherosclerosis refers to atherosclerosis of Yang deficiency, phlegm stagnation, Qi stagnation and blood stasis syndrome.

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