A traditional Chinese medicine composition and its use in treating atherosclerosis

Abstract

The application discloses a traditional Chinese medicine composition and application thereof in treatment of atherosclerosis, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: radix notoginseng 15-25 parts, Uncariae Ramulus 8-12 parts, chuanxiong rhizome 6-10 parts, chrysanthemum 2-4 parts and hawthorn 1-3 parts. The traditional Chinese medicine composition has the effects of activating blood circulation to dissipate blood stasis, calming liver to suppress yang, removing turbidity to reduce fat, dredging collaterals to protect vessels, can significantly reduce lipid deposition and plaque formation of blood vessels, improve vascular endothelial injury, can effectively intervene in the pathological process of atherosclerosis, and has excellent clinical application and industrialization popularization prospects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition and its use in the treatment of atherosclerosis. Background Technology

[0002] Atherosclerosis is a common chronic inflammatory vascular disease in clinical practice. It is the core pathological basis for cardiovascular and cerebrovascular diseases such as coronary heart disease, cerebral infarction, and peripheral vascular disease. It is characterized by high incidence, high disability rate, high mortality rate, and high recurrence rate, seriously threatening human life and health. Modern medical research shows that the core pathological mechanism of atherosclerosis is endothelial damage, lipid metabolism disorder, and excessive infiltration of inflammatory factors. Specifically, it is manifested by abnormally high levels of serum total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C), and decreased levels of high-density lipoprotein cholesterol (HDL-C). At the same time, pro-inflammatory factors such as IL-6, TNF-α, and IL-1β are expressed in large quantities, inducing lipid deposition in the vascular intima, forming atherosclerotic plaques, which in turn lead to vascular stenosis and hardening, triggering various adverse cardiovascular and cerebrovascular events.

[0003] Currently, clinical treatment of atherosclerosis often uses statins, anti-inflammatory drugs, and antiplatelet drugs. Although these drugs can regulate blood lipids and inhibit inflammation to some extent, long-term use can easily cause adverse reactions such as liver and kidney damage, gastrointestinal mucosal damage, and increased bleeding risk. Moreover, they can only provide symptomatic intervention and cannot fundamentally regulate the body's metabolism and vascular microenvironment. The relapse rate is also high after stopping the medication.

[0004] Traditional Chinese medicine (TCM) possesses unique advantages in the treatment of atherosclerosis, including holistic regulation, multi-target targeting, and low side effects. TCM categorizes atherosclerosis under the concepts of "pulse obstruction," "phlegm turbidity," and "blood stasis," with its core pathogenesis being a deficiency of the root and an excess of the branch. The excess is primarily manifested in blood stasis, phlegm turbidity, and liver yang hyperactivity, while qi and blood stagnation, internal obstruction of turbid lipids, and malnourishment of the meridians are key factors in disease progression. Existing TCM compound formulas often suffer from problems such as irrational formulation, complex ingredients, poor targeting, and insufficient synergistic effects. Some formulas also exhibit deficiencies such as missing ingredients, unbalanced proportions, and improper substitution of medicinal materials, resulting in limited lipid-lowering, anti-inflammatory, and meridian-protecting effects, failing to achieve highly efficient and precise intervention in the pathological process of atherosclerosis. Therefore, developing a refined, targeted, synergistic, and safe TCM composition for systematic intervention in atherosclerosis has significant clinical value and market potential. Summary of the Invention

[0005] To address the problems existing in the prior art, this invention provides a traditional Chinese medicine composition and its use in the treatment of atherosclerosis. The traditional Chinese medicine composition of this invention has the synergistic effects of promoting blood circulation and removing blood stasis, calming the liver and suppressing yang, eliminating turbidity and lowering lipids, and clearing the meridians and protecting the blood vessels. It can significantly intervene in the pathological process of atherosclerosis and has excellent prospects for clinical application and industrialization.

[0006] This invention is specifically implemented through the following technical solution:

[0007] This invention provides a traditional Chinese medicine composition for treating atherosclerosis, which is prepared from the following parts by weight of traditional Chinese medicinal materials: Panax notoginseng 15-25 parts, Uncaria rhynchophylla 8-12 parts, Ligusticum chuanxiong 6-10 parts, Chrysanthemum morifolium 2-4 parts, and Crataegus pinnatifida 1-3 parts.

[0008] The pharmacological properties of the traditional Chinese medicine in this invention are as follows:

[0009] Panax notoginseng: Sweet and slightly bitter in taste, warm in nature. It enters the liver and stomach meridians. Its sweet and warm properties are tonifying, while its bitterness disperses stagnation. It stops bleeding without causing blood stasis and invigorates blood without harming the body's vital energy, making it an essential medicine for invigorating blood and stopping bleeding. It has the effects of dispersing blood stasis, stopping bleeding, reducing swelling, and relieving pain. It can be used both internally and externally. Internally, it is effective in treating various types of internal and external bleeding, such as hemoptysis, hematemesis, and metrorrhagia; it can also invigorate blood and unblock meridians, improving chest and abdominal pain, traumatic swelling, and pain caused by blood stasis. Externally, it can reduce swelling and disperse blood stasis, relieving external sores and swellings. The Compendium of Materia Medica states: "Panax notoginseng stops bleeding, disperses blood stasis, and relieves pain. For wounds from weapons, arrows, falls, and beatings, where bleeding is persistent, chew it and apply it, or grind it into powder and sprinkle it on the wound; the bleeding will stop immediately. It also treats hematemesis, epistaxis, hematochezia, bloody dysentery, metrorrhagia, persistent menstruation, postpartum lochia retention, blood stasis, blood pain, red eyes, carbuncles, tiger bites, and snake bites."

[0010] Uncaria rhynchophylla: Sweet in taste and cool in nature. It enters the Liver meridian. Sweet, cool, and penetrating, it specifically enters the Liver and Pericardium, effectively clearing Liver heat, calming Liver Yang, and relieving wind and spasms. It has the effects of clearing heat, calming the Liver, relieving wind, and calming convulsions. It is mainly used to treat headaches, dizziness, irritability, and anger caused by Liver fire or Liver Yang hyperactivity; it is also effective in treating symptoms of extreme heat generating wind, and is often used for high fever convulsions, infantile convulsions, epilepsy, eclampsia, and other symptoms of Liver wind convulsions. The Compendium of Materia Medica states: "Uncaria rhynchophylla is a medicine of the Hand and Foot Jueyin meridians. The Foot Jueyin meridian governs wind, and the Hand Jueyin meridian governs fire. Epilepsy and dizziness are all diseases of Liver wind and ministerial fire. Uncaria rhynchophylla connects the Pericardium to the Liver, calming the wind and extinguishing the fire, thus eliminating all symptoms."

[0011] Chuanxiong (Ligusticum striatum): pungent in taste and warm in nature. It enters the liver, gallbladder, and pericardium meridians. Its pungent and aromatic properties penetrate and warm the blood vessels, making it a qi-regulating herb in the blood. It can promote qi circulation, invigorate blood, dispel wind, and relieve pain. It can reach the whole body and is effective in treating menstrual irregularities, dysmenorrhea, chest and rib pain, and traumatic swelling and pain caused by qi stagnation and blood stasis. Ascending to the head and eyes, it is an essential herb for treating headaches, and can be used in combination with other herbs for various types of headaches. It also unblocks the meridians and can treat rheumatic pain, limb contractures, and numbness. The *Compendium of Materia Medica* states: "It dries dampness, stops diarrhea and dysentery, promotes qi circulation, and relieves stagnation. Chuanxiong is a qi-regulating herb in the blood. The liver suffers from stagnation, so it is supplemented with pungent herbs, making it suitable for those with blood deficiency. Its pungent nature disperses qi, making it suitable for those with qi stagnation."

[0012] Chrysanthemum: Sweet and bitter in taste, slightly cold in nature. It enters the lung and liver meridians. Light and dispersing in texture, slightly cold and clearing heat, it has the effects of dispersing wind-heat, calming liver yang, clearing the liver and improving eyesight, and clearing heat and detoxifying. It is good at dispersing wind-heat in the lung meridian, treating wind-heat colds, the initial stage of febrile diseases, fever and cough; clearing liver fire, calming the liver and suppressing yang, improving headaches, dizziness, red and blurred vision caused by hyperactivity of liver yang; it can also clear heat and detoxify, treating carbuncles, boils, and red, swollen, hot and painful skin. The Compendium of Materia Medica states: "Chrysanthemum, in the past people said that it could remove wind-heat and benefit the liver and nourish yin, but they did not know that it can also benefit the metal and water organs. Nourishing water can control fire, and benefiting metal can calm wood. When wood is calmed, wind subsides, and fire is reduced, heat is eliminated. It is used to treat various wind-related headaches and eye problems, and its effects are profound and subtle."

[0013] Hawthorn: Sour and sweet in taste, slightly warm in nature. It enters the spleen, stomach, and liver meridians. Its sour and sweet properties harmonize the middle jiao (digestive system), and its slightly warm nature promotes circulation and disperses stagnation. It excels at aiding digestion, resolving food stagnation, promoting blood circulation, and removing blood stasis. It also has the function of clearing turbidity and lowering lipids. It is especially good for eliminating food stagnation caused by greasy meat, and is mainly used to treat abdominal distension due to food stagnation, belching with a foul odor, acid reflux, abdominal pain, and diarrhea. Entering the blood, it can promote qi circulation and remove blood stasis, treating chest pain, dysmenorrhea, postpartum blood stasis, and swelling and pain from falls and injuries caused by blood stasis. It can also resolve phlegm and lower lipids, regulating phlegm-dampness stagnation and hyperlipidemia. The Compendium of Materia Medica states: "It helps digestion, eliminates food stagnation and masses, phlegm retention, abdominal distension, acid reflux, and pain and distension due to blood stasis."

[0014] Furthermore, the traditional Chinese medicine composition is prepared from the following parts by weight of traditional Chinese medicinal materials: 20 parts of Panax notoginseng, 10 parts of Uncaria rhynchophylla, 8 parts of Ligusticum chuanxiong, 3 parts of Chrysanthemum morifolium, and 2 parts of Crataegus pinnatifida.

[0015] The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0016] (1) Raw material pretreatment: Weigh each Chinese medicinal material according to the weight parts, rinse with water and dry at low temperature, then pulverize and pass through a 40-60 mesh sieve to obtain medicinal powder, and store them separately for later use;

[0017] (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong, Chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 6-8 times the mass of purified water to the mixed powder, stir evenly, and soak at a constant temperature of 25-30℃ for 30-40 minutes;

[0018] (3) Segmented decoction: After soaking, boil first, then decoct for 40-50 minutes at a simmering state, and separate to obtain the first decoction; add 4-6 times the mass of purified water to the dregs, decoct again at a simmering state for 20-30 minutes, and separate to obtain the second decoction; add 4-6 times the mass of purified water to the Uncaria rhynchophylla powder, keep warm at 90℃ for 10 minutes, and separate with a filter to obtain the Uncaria rhynchophylla extract;

[0019] (4) Concentration and purification: Combine the first decoction, the second decoction and the Uncaria extract, filter with a 200-300 mesh filter to remove the residue and impurities, concentrate the filtrate under vacuum to obtain a concentrated solution, and freeze-dry under vacuum to obtain the traditional Chinese medicine composition of the present invention.

[0020] Furthermore, the medicinal materials include: 15-25 parts of Panax notoginseng, 8-12 parts of Uncaria rhynchophylla, 6-10 parts of Ligusticum chuanxiong, 2-4 parts of Chrysanthemum morifolium, and 1-3 parts of Crataegus pinnatifida.

[0021] Furthermore, in step (1), the low-temperature drying temperature is 45-55℃, and the raw material moisture content is dried to ≤8%.

[0022] Furthermore, in step (3), the temperature for both decocting processes is controlled at 95-98℃.

[0023] Further, the concentration step in step (4) is: to concentrate under reduced pressure at 60-70℃ and -0.08~-0.06MPa to a concentrate with a relative density of 1.10-1.15.

[0024] The present invention also provides a traditional Chinese medicine preparation, which is made from the aforementioned traditional Chinese medicine composition with the addition of pharmaceutically acceptable excipients.

[0025] Furthermore, the preparation is an oral preparation.

[0026] Furthermore, the oral preparation is a granule, pill, powder, or capsule.

[0027] The present invention also provides the use of the traditional Chinese medicine composition, the traditional Chinese medicine composition obtained by the preparation method, or the traditional Chinese medicine preparation in the preparation of drugs for treating atherosclerosis.

[0028] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0029] (1) Based on the core pathogenesis of atherosclerosis, namely “blood stasis obstructing the collaterals, hyperactivity of liver yang, and internal accumulation of turbid lipids”, this invention is formulated with a traditional Chinese medicine compound consisting of Panax notoginseng, Uncaria rhynchophylla, Ligusticum chuanxiong, Chrysanthemum morifolium, and Crataegus pinnatifida. Each of the principal, assistant, adjuvant, and guide herbs has its own function and their effects overlap and synergistically enhance each other. Among them, Panax notoginseng is the principal herb, which mainly invigorates blood circulation, removes blood stasis, unblocks the meridians and disperses nodules, directly targeting the root cause of blood stasis. Uncaria rhynchophylla is the assistant herb, which calms the liver and suppresses yang, clears heat and calms wind, and also addresses the symptoms of hyperactivity of liver yang, while preventing the transformation of blood stasis into heat over time. Ligusticum chuanxiong is the adjuvant herb, which promotes qi and blood circulation and guides the medicine into the meridians. It not only helps Panax notoginseng to enhance its ability to disperse blood stasis and unblock the meridians, but also works with Uncaria rhynchophylla to regulate qi and suppress liver yang. Chrysanthemum morifolium and Crataegus pinnatifida are the guide herbs. Chrysanthemum morifolium clears heat and calms the liver and clears the blood vessels, assisting Uncaria rhynchophylla in calming the liver and clearing heat. Crataegus pinnatifida promotes digestion, eliminates turbidity, lowers lipids and disperses blood stasis, and works with Panax notoginseng to resolve turbid lipids and blood stasis in the meridians. The combination of various drugs acts on multiple targets to address the multiple pathogenesis of blood stasis, liver yang hyperactivity, and turbid lipid accumulation, achieving a comprehensive intervention that integrates blood circulation promotion, liver calming, lipid reduction, and blood vessel protection.

[0030] (2) This invention uses a precise weight ratio of medicinal materials, with 15-25 parts of Panax notoginseng, 8-12 parts of Uncaria rhynchophylla, 6-10 parts of Ligusticum chuanxiong, 2-4 parts of Chrysanthemum morifolium, and 1-3 parts of Crataegus pinnatifida as the main ingredients. This creates a multi-target synergistic system that can effectively regulate lipid metabolism, inhibit vascular inflammatory response, repair vascular endothelial damage, and stabilize atherosclerotic plaques. Pharmacological experiments have confirmed that this invention solves the technical defects of existing Chinese medicine formulas, such as chaotic formulation, single efficacy, poor synergy, and unstable therapeutic effects.

[0031] (3) The traditional Chinese medicine composition of the present invention can be prepared into commonly used oral preparations such as granules and capsules, which breaks through the limitations of traditional decoctions, such as cumbersome decoction preparation, inconvenient storage, short shelf life and difficulty in precise dosage control. Among them, granules have good solubility, stable medicinal properties, convenient administration and suitable for long-term conditioning, while capsules have high drug loading capacity, precise quantification, are portable and easy to store, and are conducive to industrial mass production and standardized clinical administration. The dosage form has wide adaptability and high patient compliance, and can fully retain the original pharmacological activity of the compound. It has extremely high clinical application value and industrial promotion prospects in the preparation of drugs for the treatment of atherosclerosis. Detailed Implementation

[0032] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. After reading the present invention, any modifications of the present invention in various equivalent forms by those skilled in the art will fall within the scope defined by the appended claims.

[0033] All Chinese medicinal materials used in this invention meet the quality standards of the Chinese Pharmacopoeia (2020 edition). All experimental consumables, cells, and reagent kits are commercially available products. Unless otherwise specified, they can be obtained from conventional commercial channels or by existing known methods.

[0034] All experimental data in this invention were analyzed using SPSS 26.0 statistical software. Quantitative data were expressed as mean ± standard deviation (x ± s). One-way ANOVA was used for comparisons between groups. P < 0.05 was considered statistically significant, and P < 0.01 was considered extremely significant.

[0035] Example 1

[0036] The raw materials in this embodiment consist of the following Chinese medicinal materials in parts by weight: 20 parts of Panax notoginseng, 10 parts of Uncaria rhynchophylla, 8 parts of Ligusticum chuanxiong, 3 parts of Chrysanthemum morifolium, and 2 parts of Crataegus pinnatifida.

[0037] This embodiment provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0038] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 50℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 50-mesh standard sieve for later use.

[0039] (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong, Chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 7 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 28℃ for 35 minutes.

[0040] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to maintain a gentle boil at 96℃ and decoct for 45 minutes. Use a 300-mesh filter to separate the first decoction. Add 5 times the mass of purified water to the remaining dregs. For the second decoction, boil at 96℃ for 25 minutes and separate to obtain the second decoction. Add 5 times the mass of purified water to the Uncaria rhynchophylla powder and decoct at 90℃ for 10 minutes. Use a 300-mesh filter to separate the Uncaria rhynchophylla extract.

[0041] (4) Concentration and purification: Combine the first decoction, the second decoction and the extract of Uncaria rhynchophylla, filter twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, concentrate under reduced pressure at 65°C and -0.07MPa to a Chinese medicine concentrate with a relative density of 1.12, and freeze dry under vacuum to obtain the Chinese medicine composition of the present invention.

[0042] Example 2

[0043] The raw materials in this embodiment consist of the following Chinese medicinal materials in parts by weight: 15 parts of Panax notoginseng, 8 parts of Uncaria rhynchophylla, 6 parts of Ligusticum chuanxiong, 2 parts of Chrysanthemum morifolium, and 1 part of Crataegus pinnatifida.

[0044] This embodiment provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0045] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 45℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 40-mesh standard sieve for later use.

[0046] (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong, Chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 6 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 25℃ for 30 minutes.

[0047] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to 95℃ and simmer for 40 minutes. Use a 300-mesh filter to separate the first decoction. Add 4 times the mass of purified water to the remaining dregs. For the second decoction, simmer at 95℃ for 25 minutes. Separate to obtain the second decoction. Add 4 times the mass of purified water to the Uncaria rhynchophylla powder and keep it at 90℃ for 10 minutes. Use a 300-mesh filter to separate the Uncaria rhynchophylla extract.

[0048] (4) Concentration and purification: Combine the first decoction, the second decoction and the Uncaria extract, filter twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, concentrate under reduced pressure at 60°C and -0.06MPa to a Chinese medicine concentrate with a relative density of 1.10, and freeze dry under vacuum to obtain the Chinese medicine composition of the present invention.

[0049] Example 3

[0050] The raw materials in this embodiment consist of the following Chinese medicinal materials in parts by weight: 25 parts of Panax notoginseng, 12 parts of Uncaria rhynchophylla, 10 parts of Ligusticum chuanxiong, 4 parts of Chrysanthemum morifolium, and 3 parts of Crataegus pinnatifida.

[0051] This embodiment provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0052] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 55℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 60-mesh standard sieve for later use.

[0053] (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong, Chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 8 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 30℃ for 40 minutes.

[0054] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to maintain a gentle boil at 98℃ and decoct for 50 minutes. Use a 300-mesh filter to separate the first decoction. Add 6 times the mass of purified water to the remaining dregs. For the second decoction, boil at 98℃ for 30 minutes and separate to obtain the second decoction. Add 4 times the mass of purified water to the Uncaria rhynchophylla powder and decoct at 90℃ for 10 minutes. Use a 300-mesh filter to separate the Uncaria rhynchophylla extract.

[0055] (4) Concentration and purification: Combine the first decoction, the second decoction and the Uncaria extract, filter twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, concentrate under reduced pressure at 70°C and -0.08MPa to a Chinese medicine concentrate with a relative density of 1.15, and freeze dry under vacuum to obtain the Chinese medicine composition of the present invention.

[0056] Comparative Example 1

[0057] The raw materials for this comparative example consist of the following Chinese medicinal herbs in parts by weight: Panax notoginseng 30 parts, Ligusticum chuanxiong 8 parts, Chrysanthemum 3 parts, and Crataegus pinnatifida 2 parts (excluding Uncaria rhynchophylla).

[0058] This comparative example provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0059] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 50℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 50-mesh standard sieve for later use.

[0060] (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong, Chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 7 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 28℃ for 35 minutes.

[0061] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to maintain a gentle boil at 96℃ and decoct for 45 minutes. Use a 300-mesh filter to separate the first decoction. Add 5 times the mass of purified water to the remaining dregs. For the second decoction, decoct at a gentle boil at 96℃ for 25 minutes and separate to obtain the second decoction.

[0062] (4) Concentration and purification: Combine the first decoction and the second decoction, filter them twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, and concentrate it under reduced pressure at 65°C and -0.07MPa to a Chinese medicine concentrate with a relative density of 1.12. Vacuum freeze-dry to obtain the Chinese medicine composition of the present invention.

[0063] Comparative Example 2

[0064] The raw materials for this comparative example consist of the following Chinese medicinal herbs in parts by weight: Uncaria rhynchophylla 30 parts, Ligusticum chuanxiong 8 parts, Chrysanthemum morifolium 3 parts, and Crataegus pinnatifida 2 parts (excluding Panax notoginseng).

[0065] This comparative example provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0066] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 50℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 50-mesh standard sieve for later use.

[0067] (2) Soaking: Take the powders of Ligusticum chuanxiong, chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 7 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 28℃ for 35 minutes.

[0068] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to maintain a gentle boil at 96℃ and decoct for 45 minutes. Use a 300-mesh filter to separate the first decoction. Add 5 times the mass of purified water to the remaining dregs. For the second decoction, boil at 96℃ for 25 minutes and separate to obtain the second decoction. Add 5 times the mass of purified water to the Uncaria rhynchophylla powder and decoct at 90℃ for 10 minutes. Use a 300-mesh filter to separate the Uncaria rhynchophylla extract.

[0069] (4) Concentration and purification: Combine the first decoction, the second decoction and the extract of Uncaria rhynchophylla, filter twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, concentrate under reduced pressure at 65°C and -0.07MPa to a Chinese medicine concentrate with a relative density of 1.12, and freeze dry under vacuum to obtain the Chinese medicine composition of the present invention.

[0070] Comparative Example 3

[0071] The raw materials for this comparative example consist of the following Chinese medicinal herbs in parts by weight: Panax notoginseng 20 parts, Uncaria rhynchophylla 10 parts, Ligusticum chuanxiong 8 parts, and Chrysanthemum morifolium 5 parts (excluding hawthorn).

[0072] This comparative example provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0073] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 50℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 50-mesh standard sieve for later use.

[0074] (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong and Chrysanthemum and mix them evenly to obtain mixed powder; add 7 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 28℃ for 35 minutes.

[0075] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to maintain a gentle boil at 96℃ and decoct for 45 minutes. Use a 300-mesh filter to separate the first decoction. Add 5 times the mass of purified water to the remaining dregs. For the second decoction, boil at 96℃ for 25 minutes and separate to obtain the second decoction. Add 5 times the mass of purified water to the Uncaria rhynchophylla powder and decoct at 90℃ for 10 minutes. Use a 300-mesh filter to separate the Uncaria rhynchophylla extract.

[0076] (4) Concentration and purification: Combine the first decoction, the second decoction and the extract of Uncaria rhynchophylla, filter twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, concentrate under reduced pressure at 65°C and -0.07MPa to a Chinese medicine concentrate with a relative density of 1.12, and freeze dry under vacuum to obtain the Chinese medicine composition of the present invention.

[0077] Comparative Example 4

[0078] The raw materials for this comparative example consist of the following Chinese medicinal herbs in parts by weight: Panax notoginseng 24 parts, Uncaria rhynchophylla 14 parts, and Crataegus pinnatifida 5 parts (excluding Ligusticum chuanxiong and Chrysanthemum morifolium).

[0079] This comparative example provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0080] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 50℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 50-mesh standard sieve for later use.

[0081] (2) Soaking: Take Panax notoginseng and hawthorn powder and mix them evenly to obtain mixed powder; add 7 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 28℃ for 35 minutes.

[0082] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to maintain a gentle boil at 96℃ and decoct for 45 minutes. Use a 300-mesh filter to separate the first decoction. Add 5 times the mass of purified water to the remaining dregs. For the second decoction, boil at 96℃ for 25 minutes and separate to obtain the second decoction. Add 5 times the mass of purified water to the Uncaria rhynchophylla powder and decoct at 90℃ for 10 minutes. Use a 300-mesh filter to separate the Uncaria rhynchophylla extract.

[0083] (4) Concentration and purification: Combine the first decoction, the second decoction and the extract of Uncaria rhynchophylla, filter twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, concentrate under reduced pressure at 65°C and -0.07MPa to a Chinese medicine concentrate with a relative density of 1.12, and freeze dry under vacuum to obtain the Chinese medicine composition of the present invention.

[0084] Comparative Example 5

[0085] The raw materials for this comparative example consist of the following Chinese medicinal herbs in parts by weight: 20 parts Panax notoginseng, 10 parts Gastrodia elata, 8 parts Ligusticum chuanxiong, 3 parts Chrysanthemum morifolium, and 2 parts Crataegus pinnatifida (with Gastrodia elata of equivalent pharmacological properties replacing an equal amount of Uncaria rhynchophylla).

[0086] This comparative example provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0087] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 50℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 50-mesh standard sieve for later use.

[0088] (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong, Chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 7 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 28℃ for 35 minutes.

[0089] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to 96℃ and simmer for 45 minutes. Use a 300-mesh filter to separate the first decoction. Add 5 times the mass of purified water to the remaining dregs. For the second decoction, simmer at 96℃ for 25 minutes. Separate to obtain the second decoction. Add 5 times the mass of purified water to the Gastrodia elata powder and keep it at 90℃ for 10 minutes. Use a 300-mesh filter to separate the Gastrodia elata extract.

[0090] (4) Concentration and purification: Combine the first decoction, the second decoction and the Gastrodia elata extract, filter twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, concentrate under reduced pressure at 65°C and -0.07MPa to a Chinese medicine concentrate with a relative density of 1.12, and freeze dry under vacuum to obtain the Chinese medicine composition of the present invention.

[0091] Comparative Example 6

[0092] The raw materials for this comparative example consist of the following Chinese medicinal herbs in parts by weight: Panax notoginseng 10 parts, Uncaria rhynchophylla 20 parts, Ligusticum chuanxiong 2 parts, Chrysanthemum morifolium 3 parts, and Crataegus pinnatifida 8 parts.

[0093] This comparative example provides a method for preparing a traditional Chinese medicine composition for treating atherosclerosis, comprising the following steps:

[0094] (1) Raw material pretreatment: Weigh each Chinese medicinal material accurately according to the weight parts, rinse quickly with clean water to remove surface dust, place in a 50℃ oven and dry at low temperature until the moisture content of the raw material is ≤8%; after drying, each medicinal material is separately pulverized into powder, and then passed through a 50-mesh standard sieve for later use.

[0095] (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong, Chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 7 times the mass of purified water to the mixed powder, stir thoroughly to moisten the powder, and soak at 28℃ for 35 minutes.

[0096] (3) Segmented decoction: After soaking, heat to boiling. For the first decoction, adjust the temperature to maintain a gentle boil at 96℃ and decoct for 45 minutes. Use a 300-mesh filter to separate the first decoction. Add 5 times the mass of purified water to the remaining dregs. For the second decoction, boil at 96℃ for 25 minutes and separate to obtain the second decoction. Add 5 times the mass of purified water to the Uncaria rhynchophylla powder and decoct at 90℃ for 10 minutes. Use a 300-mesh filter to separate the Uncaria rhynchophylla extract.

[0097] (4) Concentration and purification: Combine the first decoction, the second decoction and the extract of Uncaria rhynchophylla, filter twice through a 300-mesh filter to remove fine medicinal residues, place the filtrate in a vacuum concentrator, concentrate under reduced pressure at 65°C and -0.07MPa to a Chinese medicine concentrate with a relative density of 1.12, and freeze dry under vacuum to obtain the Chinese medicine composition of the present invention.

[0098] Example 4

[0099] Take the traditional Chinese medicine composition prepared in Example 1 of this invention, add excipients at a mass ratio of traditional Chinese medicine composition: excipients = 1:2.5. The excipients are composed of dextrin and sucrose mixed in a ratio of 4:1. After thorough mixing, add an appropriate amount of purified water to make a soft material of moderate hardness. Use a swing granulator to make wet granules through a 14-mesh sieve, dry at a constant temperature of 55-60℃, control the moisture content of the granules to ≤5%, and after drying, granulate through a 12-mesh sieve to remove fine powder and coarse particles. Package and seal to obtain the traditional Chinese medicine composition granules of this invention.

[0100] Example 5

[0101] Take 95 parts of the traditional Chinese medicine composition prepared in Example 1 of this invention, and mix it with 4 parts of microcrystalline cellulose and 1 part of magnesium stearate as pharmaceutical excipients. Mix them thoroughly in a three-dimensional mixer to ensure that the uniformity and flowability of the powder meet the filling standards. Fill the capsules into No. 0 pharmaceutical empty capsules using a fully automatic capsule filling machine, with a single capsule containing 0.3g of medicine. After filling, polish, inspect, remove empty and residual capsules, and package with aluminum-plastic blister packs to obtain the capsules of the traditional Chinese medicine composition of this invention.

[0102] Experimental Example 1

[0103] This study is based on an LPS-induced HUVECs vascular endothelial inflammatory injury model. It specifically detects three types of vascular injury characteristic indicators: MCP-1, VCAM-1, and ICAM-1, and verifies the drug action mechanism from the perspectives of vascular endothelial cell microenvironment and plaque initiation infiltration mechanism.

[0104] (1) Source of experimental cells

[0105] Human umbilical vein endothelial cells (HUVECs) were purchased from Thermo Fisher Scientific, catalog number: C0035C.

[0106] (2) Test kit

[0107] Vascular adhesion factor ELISA detection kit (MCP-1, VCAM-1, ICAM-1), Wuhan Sanying Biotechnology Co., Ltd., catalog numbers: ELK1205, ELK1962, ELK1963.

[0108] (3) Experimental methods and grouping of drugs

[0109] Logarithmically growing HUVECs were seeded into 96-well plates at a density of 5 × 10³ cells / well and incubated at 37°C in a 5% CO2 incubator for 24 h. The experiment included a blank control group, a model control group, drug-treated groups for each example, and drug-treated groups for each comparative example. The model control group and each drug-treated group were treated with 2.5 μM LPS for 12 h to establish a vascular endothelial inflammation model; the blank control group was not treated with LPS stimulation and was modeled using EGM-2 complete endothelial cell culture medium (Lonza, catalog number: CC-3162). After modeling, each example and comparative example drug-treated group was treated with EGM-2 complete endothelial cell culture medium containing the corresponding traditional Chinese medicine composition, with a final concentration of 400 μg / mL of crude drug equivalent, and incubated for 72 h; the blank control group and the model control group were cultured in an equal volume of drug-free serum-free EGM-2 culture medium. After the intervention, cell supernatant was collected, and the expression levels of MCP-1, VCAM-1, ICAM-1 vascular adhesion and chemokines were detected using an ELISA kit, strictly following the kit instructions.

[0110] (4) Test results

[0111] The experimental results are shown in Table 1.

[0112] Table 1. Results of vascular adhesion and chemokine detection in HUVECs in each group (x±s, n=6)

[0113] Blank control group 25.36±3.12 10.25±1.56 8.62±1.25 Model control group <![CDATA[79.65±7.85 ## ]]> <![CDATA[38.36±5.21 ## ]]> <![CDATA[32.89±4.68 ## ]]> Example 1 Group <![CDATA[33.25±3.85 ** ]]> <![CDATA[15.62±2.85 ** ]]> <![CDATA[12.36±2.15 ** ]]> Example 2 group <![CDATA[36.85±4.12 ** ]]> <![CDATA[17.25±2.92 ** ]]> <![CDATA[14.12±2.36 ** ]]> Example 3 Group <![CDATA[31.12±3.62 ** ]]> <![CDATA[14.25±2.65 ** ]]> <![CDATA[11.25±2.02 ** ]]> Comparative Example 1 <![CDATA[68.35±6.52 && ]]> <![CDATA[32.65±4.25 && ]]> <![CDATA[28.36±3.85 && ]]> Comparative Example 2 <![CDATA[65.12±6.21 && ]]> <![CDATA[31.25±4.12 && ]]> <![CDATA[27.12±3.65 && ]]> Comparative Example 3 Groups <![CDATA[48.36±5.25 *& ]]> <![CDATA[24.65±3.52 *& ]]> <![CDATA[21.52±3.12 *& ]]> Comparative Example 4 Groups <![CDATA[50.85±5.52 *& ]]> <![CDATA[25.36±3.65 *& ]]> <![CDATA[22.25±3.25 *& ]]> Comparative Example 5 Groups <![CDATA[40.25±4.65 *& ]]> <![CDATA[22.15±3.25 *& ]]> <![CDATA[19.36±2.85 **& ]]> Comparative Example 6 Groups <![CDATA[42.62±4.85 *& ]]> <![CDATA[23.05±3.36 *& ]]> <![CDATA[20.15±2.95 *& ]]>

[0114] Note: Compared with the blank control group, ## indicates P<0.01, # indicates P<0.05; compared with the model control group, ** indicates P<0.01, * indicates P<0.05; compared with Example 1, && indicates P<0.01, & indicates P<0.05. The same applies to the following tables.

[0115] It can be seen from the data in Table 1 that compared with the blank control group, the levels of MCP-1, VCAM-1 and ICAM-1 in the model control group are extremely significantly increased (P<0.01), indicating that the vascular endothelial inflammatory injury model is successfully constructed. Compared with the model control group, the traditional Chinese medicine compositions in Examples 1-3 of the present invention significantly improve the abnormal expression of the three vascular injury factors MCP-1, VCAM-1 and ICAM-1 (P<0.01), effectively block the processes of inflammatory cell chemotaxis, adhesion and infiltration, protect the integrity of the vascular endothelial barrier, and have a significant endothelial repair effect. Compared with the model control group, since Comparative Example 1 and Comparative Example 2 do not contain Panax notoginseng or Uncaria rhynchophylla, their traditional Chinese medicine compositions have no significant improvement effect on the expression of MCP-1, VCAM-1 and ICAM-1 (P>0.05), and the effect of blocking the initial lesion of atherosclerotic plaque is not obvious; although Comparative Examples 3-6 have a certain endothelial repair effect (P<0.05 or P<0.01), there is still a significant difference from the improvement effect of Example 1 (P<0.05), and the effect of Comparative Example 5, in which Uncaria rhynchophylla is replaced by Gastrodia elata with equivalent pharmacological properties in the same amount, is also significantly lower than that of Example 1 (P<0.05). The above results indicate that the compatibility of traditional Chinese medicine raw materials of the present invention has a significant synergistic effect, and in the case of missing or replacing the traditional Chinese medicine raw materials, the synergistic effect of the compound is significantly lower than that of the examples of the present invention.

[0116] Test Example 2

[0117] This test example is based on ApoE- / - atherosclerotic model mice, and evaluates the drug efficacy from the dimensions of overall lipid metabolism disorder and systemic inflammation level of the body by detecting four blood lipid indicators (TC, TG, LDL-C, HDL-C) and core serum pro-inflammatory factors (IL-6, TNF-α, IL-1β).

[0118] (1) Source of test animals

[0119] SPF grade ApoE- / - male mice aged 6-8 weeks, weighing 18-22g, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., with the animal license number: SCXK (Beijing) 2021-0006; SPF grade C57BL / 6J normal mice were purchased from the same manufacturer.

[0120] (2) Detection kits

[0121] Four mouse blood lipid detection kits (TC, TG, LDL-C, HDL-C), Nanjing Jiancheng Bioengineering Institute, item numbers: A111-1-1, A110-1-1, A113-1-1, A112-1-1; Mouse inflammatory factor ELISA detection kits (IL-6, TNF-α, IL-1β), Wuhan Sanying Biotechnology Co., Ltd., item numbers: ELK1158, ELK1892, ELK1159.

[0122] (3) Animal model construction and grouping for drug administration

[0123] After one week of adaptive feeding, ApoE- / - mice were randomly divided into model control group, positive control group, Example 1-3 group, and Comparative Example 1-6 group, with 10 mice in each group; an additional blank control group (C57BL / 6J mice) of 10 mice was set up.

[0124] Blank control group: fed with normal feed and administered an equal amount of physiological saline by gavage daily;

[0125] For the remaining groups of mice: Atherosclerosis model was established by feeding them a high-fat diet (containing 21% fat and 0.15% cholesterol) for 12 consecutive weeks. After successful model establishment, drug intervention was started and administered for 10 consecutive weeks.

[0126] Grouped drug dosage: The positive control group was given 5 mg / kg simvastatin suspension (Hangzhou Merck Pharmaceutical Co., Ltd., National Drug Approval Number H20060368) by gavage; each drug group was given the corresponding Chinese medicine composition by gavage at a dose of 20 g crude drug / kg once a day; the blank control group and the model control group were given an equal amount of physiological saline by gavage. Mice in each group were fed and watered freely according to routine feeding and drinking.

[0127] (4) Test results

[0128] The experimental results are shown in Table 2-3.

[0129] Table 2. Results of blood lipid levels in mice in each group (x±s, n=10)

[0130] Blank control group 2.15±0.22 0.86±0.11 1.02±0.15 2.85±0.26 Model control group <![CDATA[5.89±0.45 ## ]]> <![CDATA[2.35±0.32 ## ]]> <![CDATA[3.96±0.38 ## ]]> <![CDATA[1.12±0.18 ## ]]> Positive control group <![CDATA[3.02±0.31 ** ]]> <![CDATA[1.21±0.19 ** ]]> <![CDATA[1.85±0.22 ** ]]> <![CDATA[2.41±0.23 ** ]]> Example 1 Group <![CDATA[2.81±0.28 ** ]]> <![CDATA[1.05±0.16 ** ]]> <![CDATA[1.62±0.20 ** ]]> <![CDATA[2.68±0.25* * <!-- 9 -->]]> Example 2 group <![CDATA[2.95±0.30 ** ]]> <![CDATA[1.13±0.18 ** ]]> <![CDATA[1.74±0.21 ** ]]> <![CDATA[2.55±0.24 ** ]]> Example 3 Group <![CDATA[2.76±0.27 ** ]]> <![CDATA[1.02±0.15 ** ]]> <![CDATA[1.58±0.19 ** ]]> <![CDATA[2.72±0.26 ** ]]> Comparative Example 1 <![CDATA[4.92±0.41 && ]]> <![CDATA[1.98±0.29 && ]]> <![CDATA[3.25±0.33 && ]]> <![CDATA[1.56±0.20 && ]]> Comparative Example 2 <![CDATA[4.85±0.40 && ]]> <![CDATA[1.92±0.28 && ]]> <![CDATA[3.18±0.32 && ]]> <![CDATA[1.60±0.21 && ]]> Comparative Example 3 Groups <![CDATA[3.86±0.35 *& ]]> <![CDATA[1.48±0.23 *& ]]> <![CDATA[2.42±0.27 *& ]]> <![CDATA[2.01±0.22 *& ]]> Comparative Example 4 Groups <![CDATA[4.25±0.36* && ]]> <![CDATA[1.65±0.24 *& ]]> <![CDATA[2.51±0.28 *& ]]> <![CDATA[1.35±0.21 && ]]> Comparative Example 5 Groups <![CDATA[3.42±0.32 *& ]]> <![CDATA[1.38±0.20 **& ]]> <![CDATA[2.12±0.24 *& ]]> <![CDATA[2.23±0.22 *& ]]> Comparative Example 6 Groups <![CDATA[3.51±0.33 *& ]]> <![CDATA[1.42±0.21 *& ]]> <![CDATA[2.20±0.25 *& ]]> <![CDATA[2.18±0.21 *& ]]>

[0131] As shown in Table 2, compared with the blank control group, the model control group mice showed significantly increased TC, TG, and LDL-C (P<0.01) and significantly decreased HDL-C (P<0.01), indicating that the atherosclerotic lipid metabolism disorder model was successfully constructed. Compared with the model control group, all groups in Examples 1-3 of this invention could significantly reverse the abnormal lipid metabolism indicators in mice (P<0.01). Compared with the model control group, Comparative Example 2, which lacked the principal herb Panax notoginseng, and Comparative Example 1, which lacked the assistant herb Uncaria rhynchophylla, showed weaker improvement in blood lipid indicators (P>0.05), proving that the efficacy of the Chinese medicine composition was greatly affected after the absence of the principal and assistant herbs (P>0.05). Although Comparative Example 3, which lacked the lipid-lowering adjuvant herb Crataegus pinnatifida, and Comparative Example 4, which lacked the qi-regulating and heat-clearing herbs, could improve blood lipid indicators to some extent (P<0.05), their efficacy was still significantly weaker than that of Example 1 of this invention (P<0.05 or P<0.01). The above data proves that the specific combination of five medicinal materials and the limited weight proportions of the present invention can synergistically improve lipid metabolism. The absence of medicinal materials or disordered proportions will cause the efficacy to decrease.

[0132] Table 3. Results of serum inflammatory factors in mice in each group (x±s, n=10)

[0133] Blank control group 42.36±5.21 38.52±4.68 28.65±3.52 Model control group <![CDATA[186.52±15.36 ## ]]> <![CDATA[168.35±12.89 ## ]]> <![CDATA[125.89±10.65 ## ]]> Positive control group <![CDATA[75.21±8.36 ** ]]> <![CDATA[68.95±7.52 ** ]]> <![CDATA[52.36±6.12 ** ]]> Example 1 Group <![CDATA[62.35±7.12 ** ]]> <![CDATA[58.62±6.85 ** ]]> <![CDATA[45.21±5.36 ** ]]> Example 2 group <![CDATA[68.52±7.85 ** ]]> <![CDATA[63.25±7.21 ** ]]> <![CDATA[48.65±5.89 ** ]]> Example 3 Group <![CDATA[59.86±6.92 ** ]]> <![CDATA[55.36±6.52 ** ]]> <![CDATA[42.18±5.12 ** ]]> Comparative Example 1 <![CDATA[142.35±12.65 && ]]> <![CDATA[131.25±11.36 && ]]> <![CDATA[98.52±8.65 && ]]> Comparative Example 2 <![CDATA[138.62±12.15 && ]]> <![CDATA[128.65±10.98 && ]]> <![CDATA[95.36±8.32 && ]]> Comparative Example 3 Groups <![CDATA[125.36±9.85 *&& ]]> <![CDATA[96.85±8.92 *& ]]> <![CDATA[72.15±7.12 *&& ]]> Comparative Example 4 Groups <![CDATA[108.95±10.12 *& ]]> <![CDATA[112.52±9.15 *&& ]]> <![CDATA[75.36±7.35 *&& ]]> Comparative Example 5 Groups <![CDATA[89.65±8.92 *& ]]> <![CDATA[82.36±8.12 *& ]]> <![CDATA[61.25±6.52 *& ]]> Comparative Example 6 Groups <![CDATA[92.35±9.21 *& ]]> <![CDATA[85.62±8.35 *& ]]> <![CDATA[63.89±6.85 *& ]]>

[0134] As shown in Table 3, compared with the blank control group, the serum pro-inflammatory factors IL-6, TNF-α, and IL-1β of mice in the model control group were significantly overexpressed (P<0.01), which is consistent with the core pathological characteristics of chronic persistent inflammation in atherosclerosis, further indicating that the model of the present invention was successfully constructed. Compared with the model control group, Examples 1-3 of the present invention can significantly downregulate the expression of the three types of pro-inflammatory factors (P<0.01), indicating that the traditional Chinese medicine composition of the present invention can effectively block the body's inflammatory response, with strong anti-inflammatory targeting and significant efficacy. In addition, compared with the model control group, the anti-inflammatory effect of the traditional Chinese medicine composition in Comparative Examples 1 and 2 was poor after the absence of medicinal materials, and it could not effectively improve the systemic inflammatory damage mediated by atherosclerosis (P>0.05); although Comparative Examples 3-6 can reduce the level of inflammatory factors (P<0.05), the improvement effect is significantly weaker than that of Example 1 of the present invention (P<0.05 or P<0.01). The experimental results verified the synergistic anti-inflammatory mechanism of the combination of principal, assistant, adjuvant, and guide herbs in this invention. The core medicinal materials are the key to the compound's anti-inflammatory effect. They can not only regulate the body's overall lipid metabolism and inhibit systemic inflammation, but also directly protect vascular endothelial cells and block the inflammatory adhesion and infiltration process at the initiation of plaques, thus achieving the dual effects of metabolic regulation and vascular protection in the treatment of atherosclerosis.

[0135] The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, various simple deductions or substitutions can be made without departing from the concept of the present invention, and all such modifications and substitutions should be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating atherosclerosis, characterized in that, The traditional Chinese medicine composition is prepared from the following parts by weight of traditional Chinese medicinal materials: Panax notoginseng 15-25 parts, Uncaria rhynchophylla 8-12 parts, Ligusticum chuanxiong 6-10 parts, Chrysanthemum morifolium 2-4 parts, and Crataegus pinnatifida 1-3 parts.

2. The traditional Chinese medicine composition for treating atherosclerosis according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following parts by weight of traditional Chinese medicinal materials: 20 parts of Panax notoginseng, 10 parts of Uncaria rhynchophylla, 8 parts of Ligusticum chuanxiong, 3 parts of Chrysanthemum morifolium, and 2 parts of Crataegus pinnatifida.

3. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, Includes the following steps: (1) Raw material pretreatment: Weigh out the following Chinese medicinal materials by weight: Panax notoginseng 15-25 parts, Uncaria rhynchophylla 8-12 parts, Ligusticum chuanxiong 6-10 parts, Chrysanthemum morifolium 2-4 parts, Crataegus pinnatifida 1-3 parts; rinse with water and dry at low temperature, then pulverize them through a 40-60 mesh sieve to obtain medicinal powder, and store them separately for later use. (2) Soaking: Take the powders of Panax notoginseng, Ligusticum chuanxiong, Chrysanthemum and hawthorn and mix them evenly to obtain mixed powder; add 6-8 times the mass of purified water to the mixed powder, stir evenly, and soak at a constant temperature of 25-30℃ for 30-40 minutes; (3) Segmented decoction: After soaking, boil first, then decoct for 40-50 minutes at a simmering state, and separate to obtain the first decoction; add 4-6 times the mass of purified water to the dregs, decoct again at a simmering state for 20-30 minutes, and separate to obtain the second decoction; add 4-6 times the mass of purified water to the Uncaria rhynchophylla powder, keep warm at 90℃ for 10 minutes, and separate with a filter to obtain the Uncaria rhynchophylla extract; (4) Concentration and purification: Combine the first decoction, the second decoction and the Uncaria extract, filter with a 200-300 mesh filter to remove the residue and impurities, concentrate the filtrate under vacuum to obtain a concentrated solution, and freeze-dry under vacuum to obtain the traditional Chinese medicine composition of the present invention.

4. The preparation method according to claim 3, characterized in that, In step (1), the low-temperature drying temperature is 45-55℃, and the raw material moisture content is dried to ≤8%.

5. The preparation method according to claim 3, characterized in that, In step (3), the temperature for both decocting processes is controlled at 95-98℃.

6. The preparation method according to claim 3, characterized in that, The concentration step in step (4) is to concentrate the solution to a relative density of 1.10-1.15 under reduced pressure at 60-70℃ and -0.08~-0.06MPa.

7. A traditional Chinese medicine preparation, characterized in that, It is prepared by adding pharmaceutically acceptable excipients to the traditional Chinese medicine composition according to any one of claims 1-2.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The preparation is an oral preparation.

9. The traditional Chinese medicine preparation according to claim 8, characterized in that, The oral preparations are granules, pills, powders, or capsules.

10. Use of the traditional Chinese medicine composition according to any one of claims 1-2, the traditional Chinese medicine composition obtained by the preparation method according to any one of claims 3-6, or the traditional Chinese medicine preparation according to any one of claims 7-9 in the preparation of a drug for treating atherosclerosis.