Traditional Chinese medicine composition, traditional Chinese medicine preparation and preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, a traditional Chinese medicine preparation and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 to 15 parts of radix astragali seu hedysari, 6 to 18 parts of wine-processed fructus ligustri lucidi, 4.5 to 13.5 parts of radix notoginseng, 6 to 18 parts of radix salviae miltiorrhizae, 7.5 to 22.5 parts of radix paeoniae rubra, 3.5 to 10.5 parts of rhizoma chuanxiong, 3 to 9 parts of flos carthami, 3 to 9 parts of caulis spatholobi, 4.5 to 13.5 parts of herba equiseti hiemalis, 3.5 to 10.5 parts of fructus crataegi, 3.5 to 10.5 parts of pericarpium citri reticulatae, 5 to 15 parts of rhizoma alismatis, 15 to 45 parts of concha ostreae and 3.5 to 10.5 parts of radix puerariae. The traditional Chinese medicine composition has the effects of reducing blood fat, resisting inflammation, inhibiting and reducing atherosclerotic plaque and the like, and is used for treating atherosclerosis and carotid atherosclerosis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, and a preparation method and use thereof. Background Art

[0002] Atherosclerosis has a complex pathogenesis, the main factors of which are lipid accumulation in the arterial wall and chronic inflammation. Atherosclerosis is often associated with altered lipid metabolism and hypercholesterolemia. Elevated levels of modified low-density lipoprotein (LDL) in the circulation are known risk factors for cardiovascular disease. The series of pathological events that lead to the development of atherosclerosis are believed to be caused by local endothelial dysfunction, which may be caused by blood flow disturbances near the bends or bifurcations of the arteries. The vascular endothelium responds to mechanical stress by activation, which subsequently leads to the recruitment of circulating immune cells. Circulating monocytes adhere to the damaged areas of the arterial wall and infiltrate the interior, differentiate into macrophages, actively participate in lipid uptake through phagocytosis, and produce a large number of foam cells present in atherosclerotic plaques. The pathogenesis of atherosclerosis is more complicated than changes in lipid metabolism and involves multiple factors, the most prominent of which is inflammation. In summary, there are multiple explanations for the pathogenesis, such as the lipid infiltration theory, the thrombosis theory, and the inflammatory response theory, and the treatment is mainly based on lipid-lowering, anti-inflammatory, and thrombosis prevention.

[0003] The etiology and pathogenesis of atherosclerosis in traditional Chinese medicine are also complex, mainly classified into the categories of "dizziness", "headache", "chest pain", "pulse pain" and other symptoms. Most of them are caused by factors such as congenital endowment, aging, seven emotions, fatigue, diet, etc., which lead to the deficiency of qi, blood, yin and yang, and form pathological factors such as phlegm, blood stasis, cold stagnation, qi stagnation, and heat toxicity. "Replenishing qi and strengthening spleen", "soothing liver and regulating qi", "resolving phlegm and turbidity", "activating blood circulation and removing blood stasis", "clearing heat and detoxifying" and so on are the main treatment principles for atherosclerosis.

[0004] Atherosclerosis is the pathological basis for cardiovascular and cerebrovascular diseases. Carotid atherosclerotic plaques are a serious stage of atherosclerosis, which can easily cause ischemia and infarction in the cerebral arterial blood supply area, and are one of the main causes of ischemic cerebrovascular disease. Stroke accompanied by atherosclerotic stenosis of the head and neck arteries is the main type of disease that causes severe disability and death. People are still constantly looking for new treatments, hoping to prevent or delay the occurrence and development of atherosclerosis, thereby reducing the occurrence of more serious cardiovascular and cerebrovascular diseases. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine composition and a Chinese medicine preparation prepared from the Chinese medicine composition, which has the effects of lowering blood lipids, anti-inflammatory, inhibiting and reducing atherosclerotic plaques, and is used for treating atherosclerosis and carotid atherosclerosis.

[0006] To achieve the above object, the technical solution of the present invention is as follows:

[0007] A Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-15 parts of Astragalus, 6-18 parts of Ligustrum lucidum, 4.5-13.5 parts of Panax notoginseng, 6-18 parts of Salvia miltiorrhiza, 7.5-22.5 parts of Red Peony Root, 3.5-10.5 parts of Chuanxiong, 3-9 parts of Carthamus tinctorius, 3-9 parts of Millettia reticulata, 4.5-13.5 parts of Equisetum arvense, 3.5-10.5 parts of Crataegus, 3.5-10.5 parts of Tangerine peel, 5-15 parts of Orientalis, 15-45 parts of Oyster, and 3.5-10.5 parts of Pueraria root. The above raw materials are Chinese medicinal materials or decoction pieces recorded in the Pharmacopoeia of the People's Republic of China.

[0008] Preferably, a Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts of Astragalus, 12 parts of Ligustrum lucidum, 9 parts of Panax notoginseng, 12 parts of Salvia miltiorrhiza, 15 parts of Red Peony Root, 7 parts of Chuanxiong, 6 parts of Carthamus tinctorius, 6 parts of Millettia reticulata, 9 parts of Equisetum arvense, 7 parts of Crataegus, 7 parts of Tangerine Peel, 10 parts of Alisma orientalis, 30 parts of Oyster, and 7 parts of Pueraria root.

[0009] Preferably, the Chinese medicine composition comprises the following raw materials in parts by weight: 5 parts of Astragalus, 6 parts of Ligustrum lucidum, 4.5 parts of Panax notoginseng, 6 parts of Salvia miltiorrhiza, 7.5 parts of Red Peony Root, 3.5 parts of Chuanxiong, 3 parts of Carthamus tinctorius, 3 parts of Millettia reticulata, 4.5 parts of Equisetum arvense, 3.5 parts of Crataegus pinnatifida, 3.5 parts of Citrus reticulata, 5 parts of Alisma orientalis, 15 parts of Oyster, and 3.5 parts of Pueraria root.

[0010] Preferably, the Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of Astragalus, 18 parts of Ligustrum lucidum, 13.5 parts of Panax notoginseng, 18 parts of Salvia miltiorrhiza, 22.5 parts of Red Peony Root, 10.5 parts of Chuanxiong, 9 parts of Carthamus tinctorius, 9 parts of Millettia reticulata, 13.5 parts of Equisetum arvense, 10.5 parts of Crataegus, 10.5 parts of Citrus reticulata, 15 parts of Alisma orientalis, 45 parts of Oyster, and 10.5 parts of Pueraria root.

[0011] The above-mentioned Chinese medicine composition is prepared into Chinese medicine ointment and Chinese medicine powder by the following steps:

[0012] (1) Weigh the above raw materials in parts by weight;

[0013] (2) crushing Panax notoginseng into fine powder;

[0014] (3) Mix astragalus, Ligustrum lucidum, salvia miltiorrhiza, red peony root, ligusticum chuanxiong, safflower, Millettia reticulata, horsetail, hawthorn, dried orange peel, oriental rhizome, oyster, and kudzu root, add water and boil three times, add 7-9 times the amount of water for the first time and boil for 1-3 hours, add 5-7 times the amount of water for the second time and boil for 1-3 hours, add 3-5 times the amount of water for the third time and boil for 0.5-2 hours, filter, and concentrate the filtrate to a thick paste with a relative density of 1.15-1.25 at 60°C;

[0015] (4) mixing the thick paste prepared in step (3) and the Panax notoginseng powder prepared in step (2) to obtain a Chinese medicine paste; further vacuum drying to obtain a dry paste, and crushing to obtain a fine powder to obtain a Chinese medicine powder.

[0016] The use of the Chinese medicine composition, Chinese medicine ointment and Chinese medicine powder described in the above technical scheme in preparing drugs for treating atherosclerosis and carotid atherosclerosis.

[0017] A traditional Chinese medicine preparation comprises a traditional Chinese medicine composition or a traditional Chinese medicine ointment or a traditional Chinese medicine powder and a pharmaceutically acceptable carrier.

[0018] In the Chinese medicine preparation described in the above technical solution, the weight portion of the pharmaceutically acceptable carrier is 1-100 parts relative to the Chinese medicinal material.

[0019] As an improvement to the Chinese medicine preparation described in the above technical solution, the pharmaceutically acceptable carrier is one or a combination of starch, cellulose, starch derivatives, cellulose derivatives, honey, sugar, antibacterial agents, ethanol, water, etc.

[0020] The weight portion of the pharmaceutically acceptable carrier in the Chinese medicine preparation of the present invention is 1-100 parts, and the amount and type of the carrier added do not affect the effect of the Chinese medicine preparation on treating atherosclerosis and carotid atherosclerosis. The weight portion of the carrier here has the same meaning as the weight portion of the Chinese medicinal materials in the Chinese medicine composition, that is, the Chinese medicine preparation includes 5-15 parts of Astragalus, 6-18 parts of Ligustrum lucidum, 4.5-13.5 parts of Panax notoginseng, 6-18 parts of Salvia miltiorrhiza, 7.5-22.5 parts of Red Peony Root, 3.5-10.5 parts of Chuanxiong, 3-9 parts of Carthamus tinctorius, 3-9 parts of Millettia reticulata, 4.5-13.5 parts of Equisetum arvense, 3.5-10.5 parts of Crataegus, 3.5-10.5 parts of Tangerine peel, 5-15 parts of Orientalis, 15-45 parts of Oyster, 3.5-10.5 parts of Puerariae Radix, and 1-100 parts of the pharmaceutically acceptable carrier.

[0021] The preparation method of the above-mentioned Chinese medicine preparation comprises the following steps:

[0022] (1) Weighing the raw materials in parts by weight;

[0023] (2) crushing Panax notoginseng into fine powder;

[0024] (3) Mix astragalus, Ligustrum lucidum, salvia miltiorrhiza, red peony root, ligusticum chuanxiong, safflower, Millettia reticulata, horsetail, hawthorn, dried orange peel, oriental rhizome, oyster, and kudzu root, add water and boil three times, add 7-9 times the amount of water for the first time and boil for 1-3 hours, add 5-7 times the amount of water for the second time and boil for 1-3 hours, add 3-5 times the amount of water for the third time and boil for 0.5-2 hours, filter, and concentrate the filtrate to a thick paste with a relative density (based on water) of 1.15-1.25 at 60°C;

[0025] (4) Mix the thick paste prepared in step (3), the Panax notoginseng powder prepared in step (2), and a pharmaceutically acceptable carrier to obtain a decoction paste; mix the thick paste prepared in step (3) and the Panax notoginseng powder prepared in step (2), vacuum dry them into a dry paste, grind them into fine powder, add an appropriate amount of a pharmaceutically acceptable carrier, mix them, granulate them, and dry them to obtain granules; further press them into tablets to obtain tablets.

[0026] The present invention can be made into preparations of various dosage forms, such as tablets, capsules, granules, pills, powders, syrups, oral liquids, decoctions, mixtures, etc., according to the types of pharmaceutically acceptable carriers added and the preparation methods adopted.

[0027] The present invention can also directly mix the various Chinese medicines in the Chinese medicine composition and boil them to obtain the Chinese medicine decoction.

[0028] The preparation method of the traditional Chinese medicine preparation described in the above technical scheme, wherein the pharmaceutically acceptable carrier is one or a combination of several selected from starch, cellulose, starch derivatives, cellulose derivatives, honey, sugar, antibacterial agents, ethanol, water, etc.

[0029] Use of the Chinese medicine preparation described in any of the above technical solutions in drugs for treating atherosclerosis and carotid atherosclerosis.

[0030] The pathogenesis of this disease can be divided into deficiency of the root and excess of the side. The root deficiency is mostly qi deficiency; the excess of the side is more common with blood stasis, phlegm turbidity, and qi stagnation. The pathogenesis of blood stasis runs through the whole process of the onset of this disease. Qi deficiency leads to blood stasis, and the vital energy is weak, unable to promote blood circulation, resulting in poor blood circulation and blood stasis, which is qi deficiency causing blood stasis. Qi deficiency leads to obstacles in the distribution of water, and the water and moisture do not disperse, gather and form phlegm, condense inside, and then become phlegm turbidity. The present invention takes into account both the deficiency and excess of the root and the side, and uses Astragalus to greatly replenish the vital energy, so that the qi is strong and the blood is flowing, and the stasis is removed without hurting the body, and the qi is replenished and the foundation is strengthened, which is the main medicine. Wine Ligustrum lucidum and Panax notoginseng are used to assist Astragalus, which is mainly used to nourish the liver and kidney, and replenish the deficiency of qi, blood, yin and yang, and are ministerial medicines. The drugs of salvia miltiorrhiza, red peony root, chuanxiong, safflower, millettia reticulata, horsetail, etc. can invigorate blood circulation, promote blood circulation, promote qi circulation, and dissipate blood stasis. They can also nourish blood and restore vitality, promote the generation of new blood after removing blood stasis, and replenish blood vessels. The drugs of hawthorn, tangerine peel, oriental rhizome, and oyster can dissipate stasis, promote diuresis, and dissipate phlegm and turbidity, and they are all adjuvant drugs. The root of kudzu root can promote body fluid and quench thirst, promote blood circulation, treat various arthralgia, and relieve the exterior and interior, and it is the guiding drug. The whole prescription can achieve the effects of invigorating qi and promoting blood circulation, removing blood stasis and dissipating turbidity, so that the symptoms are reduced and suppressed.

[0031] The Chinese medicine composition and the preparation thereof have the effects of lowering blood lipids, resisting inflammation, inhibiting and reducing atherosclerotic plaques, and can effectively treat atherosclerosis and carotid atherosclerosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is a representative picture of the aorta's Oil Red O macroscopic staining;

[0033] Figure 2 This is a representative picture of HE staining of aorta paraffin sections;

[0034] Figure 3 Representative images of Masson staining of aorta paraffin sections. DETAILED DESCRIPTION

[0035] The technical solution of the present invention is described in detail below with reference to the accompanying drawings and embodiments.

[0036] Embodiment 1:

[0037] Astragalus 5g, Ligustrum lucidum 6g, Panax notoginseng 4.5g, Salvia miltiorrhiza 6g, Paeonia lactiflora 7.5g, Ligusticum chuanxiong 3.5g, Carthamus tinctorius 3g, Millettia reticulata 3g, Equisetum equisetum 4.5g, Crataegus pinnatifida 3.5g, Citrus reticulata peel 3.5g, Alisma orientalis 5g, Oyster 15g, Pueraria lobata 3.5g. Grind Panax notoginseng into fine powder; mix Astragalus, Ligustrum lucidum, Salvia miltiorrhiza, Paeonia lactiflora, Ligusticum chuanxiong, Safflower, Millettia spatholobi, Equisetum equisetum, Crataegus pinnatifida, Citrus reticulata, Alisma orientalis, Oyster and Pueraria root, add water and boil for three times, add water 8 times the total weight of the medicinal materials for the first time and boil for 2 hours, filter, add 6 times the amount of water to the residue and boil for 2 hours, filter, add 4 times the amount of water to the residue and boil for 1 hour, filter, and concentrate the filtrate to a thick paste with a relative density of 1.15 to 1.25 at 60°C; mix the thick paste and Panax notoginseng powder, vacuum dry into a dry paste, grind into fine powder, and obtain Chinese medicine powder as a daily dose for adults.

[0038] Embodiment 2:

[0039] Astragalus 10g, Ligustrum lucidum 12g, Panax notoginseng 9g, Salvia miltiorrhiza 12g, Paeonia lactiflora 15g, Chuanxiong 7g, Carthamus tinctorius 6g, Millettia spatholobi 6g, Equisetum equisetum 9g, Hawthorn 7g, Tangerine peel 7g, Orientia 10g, Oyster 30g, Pueraria lobata 7g. Grind Panax notoginseng into fine powder; Mix Astragalus, Ligustrum lucidum, Salvia miltiorrhiza, Paeonia lactiflora, Chuanxiong, Carthamus tinctorius, Millettia spatholobi, Equisetum equisetum, Hawthorn 7g, Tangerine peel, Orientia spatholobi, Oyster, Pueraria lobata, add water and decoct three times, add 8 times the total weight of the medicinal materials for the first time, decoct for 2 hours, filter, add 6 times the amount of water to the residue, decoct for 2 hours, filter, add 4 times the amount of water to the residue, decoct for 1 hour, filter, and concentrate the filtrate to a thick paste with a relative density of 1.15 to 1.25 at 60°C; mix the thick paste and Panax notoginseng powder, vacuum dry to a dry paste, and grind into fine powder to obtain Chinese medicine powder as a daily dosage for adults.

[0040] Embodiment 3:

[0041] Astragalus 15g, Ligustrum lucidum 18g, Panax notoginseng 13.5g, Salvia miltiorrhiza 18g, Paeonia lactiflora 22.5g, Ligusticum chuanxiong 10.5g, Carthamus tinctorius 9g, Millettia reticulata 9g, Equisetum equisetum 13.5g, Crataegus pinnatifida 10.5g, Citrus reticulata peel 10.5, Alisma orientalis 15g, Oyster 45g, Pueraria lobata 10.5g. Grind Panax notoginseng into fine powder; mix Astragalus, Ligustrum lucidum, Salvia miltiorrhiza, Paeonia lactiflora, Ligusticum chuanxiong, Safflower, Millettia spatholobi, Equisetum equisetum, Crataegus pinnatifida, Citrus reticulata, Alisma orientalis, Oyster and Pueraria root, add water and boil for three times, add water 8 times the total weight of the medicinal materials for the first time and boil for 2 hours, filter, add 6 times the amount of water to the residue and boil for 2 hours, filter, add 4 times the amount of water to the residue and boil for 1 hour, filter, and concentrate the filtrate to a thick paste with a relative density of 1.15 to 1.25 at 60°C; mix the thick paste and Panax notoginseng powder, vacuum dry into a dry paste, grind into fine powder, and obtain Chinese medicine powder as a daily dose for adults.

[0042] Embodiment 4:

[0043] Astragalus 15g, Ligustrum lucidum 18g, Panax notoginseng 13.5g, Salvia miltiorrhiza 18g, Paeonia lactiflora 22.5g, Ligusticum chuanxiong 10.5g, Carthamus tinctorius 9g, Millettia reticulata 9g, Equisetum equisetum 13.5g, Crataegus pinnatifida 10.5g, Citrus reticulata peel 10.5, Alisma orientalis 15g, Oyster 45g, Pueraria lobata 10.5g. Grind Panax notoginseng into fine powder; mix Astragalus, Ligustrum lucidum, Salvia miltiorrhiza, Paeonia lactiflora, Ligusticum chuanxiong, Carthamus tinctorius, Millettia reticulata, Equisetum equisetum, Crataegus pinnatifida, Citrus reticulata, Alisma orientalis, Oyster and Pueraria root, add water and boil three times, add 8 times the total weight of the medicinal materials for the first time, boil for 2 hours, filter, add 6 times the amount of water to the residue and boil for 2 hours, filter, add 4 times the amount of water to the residue and boil for 1 hour, filter, and concentrate the filtrate to a thick paste with a relative density of 1.15 to 1.25 at 60°C; mix the thick paste, Panax notoginseng powder and 10g of honey to obtain a decoction of Chinese medicine preparation.

[0044] Embodiment 5:

[0045] 5 parts of Astragalus, 6 parts of Ligustrum lucidum, 4.5 parts of Panax notoginseng, 6 parts of Salvia miltiorrhiza, 7.5 parts of Red Peony Root, 3.5 parts of Chuanxiong, 3 parts of Carthamus tinctorius, 3 parts of Millettia reticulata, 4.5 parts of Equisetum arvense, 3.5 parts of Crataegus, 3.5 parts of Citrus reticulata, 5 parts of Alismatis, 15 parts of Oyster, and 3.5 parts of Pueraria. Grind Panax notoginseng into fine powder; mix Astragalus, Ligustrum lucidum, Salvia miltiorrhiza, Paeonia lactiflora, Ligusticum chuanxiong, Carthamus tinctorius, Millettia reticulata, Equisetum equisetum, Crataegus pinnatifida, Citrus reticulata, Alisma orientalis, Oyster and Pueraria root, add water and boil for three times, add water 8 times the total weight of the medicinal materials for the first time, boil for 2 hours, filter, add 6 times the amount of water to the residue and boil for 2 hours, filter, add 4 times the amount of water to the residue and boil for 1 hour, filter, and concentrate the filtrate to a thick paste with a relative density of 1.15-1.25 at 60°C; mix the thick paste and Panax notoginseng powder, vacuum dry to form a dry paste, grind into fine powder, add 10 parts of low-substituted hydroxypropyl cellulose, mix, granulate with 75% ethanol, dry, and granulate to obtain Chinese medicine granules.

[0046] The following is a specific test example to further illustrate the beneficial effects of the Chinese medicine composition of the present invention when used to prepare a drug for treating atherosclerosis:

[0047] 1. Experimental Animals

[0048] ApoE knockout mice were fed a high-fat diet for 6 weeks to create an atherosclerosis animal model, and C57 mice were used as a control group.

[0049] 2. Grouping

[0050] The mice in the atherosclerosis model group were randomly divided into a model group, an atorvastatin calcium group (clinical 20 mg / person / day converted to a mouse equivalent dose of 3 mg / kg / day), a low-dose, medium-dose, and high-dose groups of Chinese medicine powder (the doses correspond to the Chinese medicine powder described in Example 1, Example 2, and Example 3, respectively, and the mouse equivalent dose is about 3.4 g / kg / day, 6.8 g / kg / day, and 10.2 g / kg / day). The mice in the control group continued to be fed with ordinary feed, and the mice in the other groups continued to be fed with high-fat feed, and at the same time, drug intervention was given, once a day, and the drug was dissolved in an appropriate amount of water and then continuously gavaged for 12 weeks, and the administration volume was 20 ml / kg / day.

[0051] 3. Specimen collection:

[0052] Blood collection: After the administration of each group, blood was collected from the medial canthal vein of the mice, mixed in a test tube containing EDTA-K2 anticoagulant, and centrifuged at 4°C and 3000r / min for 15min. The upper plasma was collected and stored at -80°C for later use.

[0053] Collection of aortic tissue: After blood was drawn, the mice were killed, the thorax was opened along the midline of the chest, the heart and thoracic aorta were fully exposed, and sterile PBS solution was used for perfusion from the apex of the heart. The solution was slowly injected for about 5-10 minutes until the liver turned white, and then the complete aorta and heart located on the left front side of the spine were exposed. The adipose tissue around the aorta was gently peeled off with ophthalmic forceps, and the branches that emerged during the course of the aorta were carefully cut off. The complete macrovascular specimens and heart from the common carotid artery, pulmonary artery and coronary artery bifurcation to the iliac artery bifurcation were separated, and the aorta was stained with Oil Red O, the aortic arch was stained with Masson, and the aortic arch sections were stained with HE.

[0054] 4. Pharmacodynamic evaluation

[0055] 4.1 Determination of blood lipid indexes, including detection of plasma TCHO (total cholesterol), TG (total triglycerides), LDL (low-density lipoprotein), HDL (high-density lipoprotein), lipoprotein B content, etc.

[0056] 4.2 Detection of inflammatory factors

[0057] The ELISA method was used to detect various inflammatory factors in mouse plasma, including IL-4, IL-17, TNF-α, IL-6, IL-1β, IL-10, etc.

[0058] 4.3 The distribution of aortic lipid plaques and the degree of lesions were detected by Oil Red O staining of the aorta, Masson staining of the aortic arch, and HE staining of the aortic arch sections.

[0059] 4.3.1 Aorta gross oil red O staining: 1) Place the gross blood vessel specimen in 4% paraformaldehyde for fixation for more than 24 hours, take it out and rinse it twice with PBS buffer, and carefully cut the blood vessel longitudinally with spring scissors. 2) Immerse the cut blood vessel in modified oil red O staining solution, stain it at 37℃ for 30 minutes, and differentiate it into milky white with 60% isopropanol, so that the fat plaques on the inner side of the blood vessel wall are orange-red or bright red, and the rest of the position is almost colorless. 3) After washing with distilled water twice, the stained gross blood vessel specimen is flat and fixed on a black plate for photography. Check the distribution of plaques under a microscope, take pictures and record them. Use Image J software to calculate the aortic lipid plaque ratio, that is, the ratio of the aortic red lipid plaque area to the entire aorta area, and use SPSS20.0 software to compare and analyze whether there is any difference in the ratio between the two groups.

[0060] 4.3.2Masson staining: The aortic arch of mice was fixed, embedded in paraffin, sliced ​​at 4 μm, dewaxed to water and then stained with Masson staining: hematoxylin for 5 min, acidic ethanol for 10 s, Masson blueing solution for 5 min, Ponceau fuchsin for 8 min, weak acid working solution for 1 min, phosphomolybdic acid for 1 min, weak acid working solution for 1 min, aniline blue for 1 min, weak acid working solution for 1 min, gradient ethanol dehydration, and xylene immersion for 3 times. The slides were sealed and images were collected under a microscope. The percentage of collagen in the mouse aortic vascular plaques was measured using microscopic image analysis software (Image J).

[0061] 4.3.3 HE staining of aortic root sections: The aortic root was made into paraffin sections for HE staining, that is, the sections were dewaxed and placed in a hematoxylin aqueous solution for staining for several minutes, ammonia solution for colorimetry, rinsed, stained with alcohol eosin for 2-3 minutes, dehydrated with alcohol, and sealed with xylene for transparency, and then photographed under a microscope. Image J software was used to quantitatively analyze the percentage of HE staining plaque area to aortic lumen area in each section.

[0062] 5. Test results

[0063] 5.1 Blood lipid index

[0064] As shown in Table 1, after 12 weeks of administration, the blood lipid indexes of each dose group of Chinese medicine powder were greatly improved compared with the model group. Compared with the control group, the triglyceride (TG) content of the model group was significantly increased (P<0.01), and the TG content of mice in the small and medium dose groups of Chinese medicine powder was significantly lower than that of the model group (P<0.05). At the same time, the total cholesterol (TCHO) content of the model group was significantly increased (P<0.001), and the TCHO content of mice in the medium dose group of Chinese medicine powder was significantly lower than that of the model group (P<0.05). There was no significant difference in the high-density lipoprotein (HDL) content of each group. The low-density lipoprotein (LDL) content of the model group was higher than that of the control group (P<0.001), and the LDL content of mice in the medium dose group of Chinese medicine powder and atorvastatin calcium treatment group was significantly lower than that of the model group (P<0.05). The apolipoprotein B (ApoB) content of the model group was significantly higher than that of the control group (P<0.001), and the ApoB content of the medium dose group of Chinese medicine powder was significantly lower than that of the model group (P<0.05). In summary, the blood lipid indicators of atherosclerosis model mice were significantly higher than those of the control group, and the Chinese medicine powder had the effect of significantly improving the hyperlipidemia and lowering blood lipids in the model mice.

[0065] Table 1 Detection of blood lipid indexes of APOE+ / - mice model of atherosclerosis by Chinese medicinal powder (x±s, n=10)

[0066]

[0067] Note: Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0068] 5.2 Inflammatory factor indicators

[0069] Atherosclerosis is a multifactorial disease, and inflammation mediates the entire process of its occurrence and development. Inflammatory markers have become the main indicators of the stability and prognosis of atherosclerosis. As shown in Table 2, compared with the control group, the levels of IL-4 (regulating humoral immunity and adaptive immunity), IL-17 (an inflammatory cytokine mainly produced by activated T cells), IL-1β (attracting neutrophils, causing the release of inflammatory mediators, etc.), IL-2 (inducing cytotoxicity and promoting inflammatory response), IL-6 (inflammatory effector factor), mouse growth regulatory oncogene α (KC), IL-10 (inhibiting the release of inflammatory mediators by mononuclear macrophages and enhancing the release of anti-inflammatory factors), TNF-α (inflammatory effector factor), IL-23p19 (promoting the production of INF-γ) and monocyte chemoattractant protein (MCP-1) (promoting the secretion of inflammatory factors) in the model group mice were significantly increased (P<0.05, P<0.001), indicating that the body is in a state of obvious inflammatory activation when atherosclerosis occurs. After treatment with Chinese herbal powder, the above-mentioned inflammatory indicators in mice showed a downward trend compared with those in the model group (IL-10 showed an increasing trend). Among them, the reduction of IL-4, IL-1β, IL-23p19 and MCP-1 in the medium-dose group was significantly different (P<0.05), and the IL-10 level was significantly higher than that in the model group (P<0.05). All of the above indicate that Chinese herbal powder has a significant anti-inflammatory effect.

[0070] Table 2 Detection of inflammatory factors in APOE+ / - mice with atherosclerosis model by Chinese medicinal powder (x±s, n=12)

[0071]

[0072] Note: Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0073] 5.3 Macroscopic observation of aorta with Oil Red O and HE and Masson staining

[0074] Depend on Figure 1 ( Figure 1 A is the model group; B, C, and D are the low-, medium-, and high-dose groups of traditional Chinese medicine powder, respectively; E is the atorvastatin calcium group; and F is the control group). It can be seen that the fatty plaques on the vascular wall of each group were stained red by Oil Red O, and the percentage of the total plaque area to the entire intima area was calculated to compare the relative area of ​​plaque formation in the aorta of each group; as shown in Table 3, the plaque area in the model group was significantly higher than that in the control group (P<0.001), indicating that the atherosclerosis model was successfully established. The percentage of plaque area to the total intima area in each dose group of traditional Chinese medicine powder showed a decreasing trend compared with the model group, among which the medium-dose group and the high-dose group were significantly reduced (P<0.05). In addition, the cross-section of the aortic arch of the mouse was stained with HE. After the staining was completed, it was observed and photographed under a light microscope. Figure 2 ( Figure 2 A is the model group, B, C, and D are the low, medium, and high dose groups of Chinese medicine powder, respectively, E is the atorvastatin calcium group, and F is the control group); the image was calculated using Image J software to calculate the lumen area and plaque area, and the total plaque area divided by the lumen area is the relative size of the plaque. As shown in Table 3, the proportion of aortic arch plaque area in the model group was significantly higher than that in the control group (P<0.001), and the proportion of aortic arch plaque area in each dose group of Chinese medicine powder showed a downward trend. Masson trichrome staining is a classic staining technique for evaluating collagen fibers, which can distinguish collagen fibers from muscle fibers. After staining, muscle fibers appear red and collagen fibers appear blue. It can be used to evaluate the collagen content in atherosclerotic plaques, see Figure 3 ( Figure 3 A is the model group, B, C, and D are the low, medium, and high dose groups of Chinese medicine powder, E is the atorvastatin calcium group, and F is the control group); it is generally believed that the higher the relative content of collagen in the plaque, the more stable the plaque. As shown in Table 3, the collagen content of the plaques in each group of Chinese medicine powder was significantly increased compared with the model group (P<0.05). All of the above indicate that the Chinese medicine composition can significantly reduce plaques, inhibit the development of plaques, and enhance the stability of plaques, and has a significant anti-atherosclerotic effect.

[0075] Table 3 Results of pathological staining of aorta of APOE+ / - mice with Chinese medicinal powder on atherosclerosis model (x±s, n=6)

[0076]

[0077] Note: Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0078] Experimental studies have shown that the small, medium and large dose groups all have effects, which are not inferior to the atorvastatin calcium group, especially the TG and ApoB in the blood lipid index of the medium dose group, the IL-10, IL-23p19, MCP-1 in the inflammatory factor index, the aortic vascular wall fat plaque area ratio of the medium and large dose groups, the plaque area ratio index of the aortic arch cross section of each dose group, and the collagen area ratio of the plaque area in the large dose group are all better than the atorvastatin calcium group. The Chinese medicine composition of the present invention has significant effects of lowering blood lipids, anti-inflammatory, inhibiting and reducing the formation of atherosclerotic plaques, so as to effectively treat atherosclerosis and carotid atherosclerosis.

[0079] Any contents not described in detail in the present invention can be based on the conventional technical knowledge in the art.

[0080] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention is described in detail with reference to the embodiments, it should be understood by those skilled in the art that any modification or equivalent replacement of the technical solutions of the present invention does not depart from the spirit and scope of the technical solutions of the present invention and should be included in the scope of the claims of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 5-15 parts of astragalus, 6-18 parts of Ligustrum lucidum, 4.5-13.5 parts of Panax notoginseng, 6-18 parts of Salvia miltiorrhiza, 7.5-22.5 parts of red peony root, 3.5-10.5 parts of Chuanxiong, 3-9 parts of safflower, 3-9 parts of Millettia reticulata, 4.5-13.5 parts of Equisetum arvense, 3.5-10.5 parts of hawthorn, 3.5-10.5 parts of dried tangerine peel, 5-15 parts of Alismatis, 15-45 parts of oyster and 3.5-10.5 parts of Pueraria root.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 5 parts of astragalus, 6 parts of Ligustrum lucidum, 4.5 parts of Panax notoginseng, 6 parts of Salvia miltiorrhiza, 7.5 parts of Paeonia lactiflora, 3.5 parts of Chuanxiong, 3 parts of Carthamus tinctorius, 3 parts of Millettia reticulata, 4.5 parts of Equisetum arvense, 3.5 parts of Crataegus pinnatifida, 3.5 parts of Citrus reticulatae, 5 parts of Alisma orientalis, 15 parts of Oyster and 3.5 parts of Pueraria root.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of astragalus, 12 parts of Ligustrum lucidum, 9 parts of Panax notoginseng, 12 parts of Salvia miltiorrhiza, 15 parts of Paeonia lactiflora, 7 parts of Chuanxiong, 6 parts of Carthamus tinctorius, 6 parts of Millettia reticulata, 9 parts of Equisetum arvense, 7 parts of Crataegus pinnatifida, 7 parts of Citrus reticulatae, 10 parts of Alisma orientalis, 30 parts of Oyster and 7 parts of Pueraria root.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of astragalus, 18 parts of Ligustrum lucidum, 13.5 parts of Panax notoginseng, 18 parts of Salvia miltiorrhiza, 22.5 parts of Paeonia lactiflora, 10.5 parts of Chuanxiong, 9 parts of Carthamus tinctorius, 9 parts of Millettia reticulata, 13.5 parts of Equisetum arvense, 10.5 parts of Crataegus pinnatifida, 10.5 parts of Citrus reticulata, 15 parts of Orientalis, 45 parts of Oyster and 10.5 parts of Pueraria root.

5. A method for preparing a Chinese medicine composition, the preparation method comprising: (1) Weighing the raw materials according to any one of claims 1 to 4 in parts by weight; (2) crushing Panax notoginseng into fine powder; (3) Mix astragalus, Ligustrum lucidum, salvia miltiorrhiza, red peony root, ligusticum chuanxiong, safflower, Millettia reticulata, horsetail, hawthorn, dried orange peel, oriental rhizome, oyster, and kudzu root, add water and boil three times, add 7-9 times the amount of water for the first time and boil for 1-3 hours, add 5-7 times the amount of water for the second time and boil for 1-3 hours, add 3-5 times the amount of water for the third time and boil for 0.5-2 hours, filter, and concentrate the filtrate to a thick paste with a relative density of 1.15-1.25 at 60°C; (4) The thick paste prepared in step (3) and the Panax notoginseng powder prepared in step (2) are mixed to obtain a Chinese medicine paste; the Chinese medicine paste is further vacuum dried to become a dry paste, and crushed into fine powder to obtain Chinese medicine powder.

6. A Chinese medicine preparation, comprising a Chinese medicine composition or a Chinese medicine ointment or a Chinese medicine powder and a pharmaceutically acceptable carrier, characterized in that: The Chinese medicine composition is the Chinese medicine composition according to any one of claims 1 to 4, and the Chinese medicine ointment or Chinese medicine powder is the Chinese medicine ointment or Chinese medicine powder according to claim 5.

7. The Chinese medicine preparation according to claim 6, characterized in that: The weight proportion of the pharmaceutically acceptable carrier is 1-100 parts; the pharmaceutically acceptable carrier is one or a combination of starch, cellulose, starch derivatives, cellulose derivatives, sugar, honey, antibacterial agent, ethanol and water.

8. The Chinese medicine preparation according to claim 6, characterized in that: The dosage form of the Chinese medicine preparation is tablet, capsule, granule, pill, powder, syrup, oral liquid, decoction or mixture.

9. A method for preparing the Chinese medicine preparation according to any one of claims 6 to 8, comprising the following steps: The liquid medicine extracted from the Chinese medicine composition is concentrated into a thick paste, and an appropriate amount of a pharmaceutically acceptable carrier is added, and mixed to obtain a decoction paste or an oral solution; Alternatively, a decoction is obtained by adding a proper amount of a pharmaceutically acceptable carrier to the Chinese medicinal ointment and mixing evenly; Alternatively, the liquid medicine extracted from the Chinese medicine composition is concentrated into a thick paste, then dried into a dry paste, crushed, added with an appropriate amount of a pharmaceutically acceptable carrier to granulate, and dried to obtain a granule; Alternatively, the Chinese medicine powder is added with an appropriate amount of a pharmaceutically acceptable carrier to granulate, and then dried to obtain granules; the granules can be further compressed into tablets.

10. Use of the Chinese medicine composition according to claims 1 to 4 or the Chinese medicine preparation according to any one of claims 6 to 8 in preparing a drug for treating atherosclerosis and / or carotid atherosclerosis.

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