Traditional Chinese medicine composition with effects of reducing blood fat and resisting carotid atherosclerotic plaque and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition with effects of reducing blood fat and resisting carotid atherosclerotic plaque and a preparation method of the traditional Chinese medicine composition. The composition is innovatively cut by taking eight-treasure soup as a basic framework, and comprises American ginseng, astragalus membranaceus, lucid ganoderma, saffron crocus extract, saussurea involucrata culture, donkey-hide gelatin, angelica sinensis, prepared rehmannia root, peach kernel, hawthorn, semen cassiae, lotus leaf, mulberry leaf, dandelion, hovenia dulcis thunb, kudzu vine root, radix polygonati officinalis, poria cocos, coix seed, orange peel, fructus amomi and honey-fried licorice root. American ginseng is used for replacing ginseng, radix astragali is used for reinforcing qi tonifying, saffron crocus, peach kernels, hawthorn fruits and the like are matched for reinforcing blood circulation promoting and blood stasis removing, semen cassiae, lotus leaves and other medicine groups for clearing heat, reducing phlegm and descending turbidity are added, and meanwhile fructus amomi and orange peel are used for strengthening the spleen and regulating qi. The traditional Chinese medicine composition has the effects of supporting the healthy energy and treating phlegm and blood stasis on the pathogenesis of qi-blood deficiency and phlegm and blood stasis, and has a synergistic enhancement effect on the aspects of reducing blood fat and inhibiting atherosclerotic plaque.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine formulation technology, and in particular to a traditional Chinese medicine composition with lipid-lowering and anti-carotid atherosclerotic plaque effects and its preparation method. Background Technology

[0002] Carotid atherosclerosis is the local manifestation of systemic atherosclerosis in the carotid arteries. As a chronic inflammatory disease characterized by the formation of subintimal lipid plaques in the carotid arteries, it is a crucial pathological basis for ischemic stroke and transient ischemic attack (TIA). Its occurrence and development are clearly and critically linked to dyslipidemia, particularly hypercholesterolemia and hypertriglyceridemia. According to the lipid infiltration theory, abnormally elevated lipids in the bloodstream (mainly cholesterol and triglycerides) infiltrate and deposit in the subintimal region of blood vessels with unique hemodynamic characteristics, such as the carotid bifurcation, triggering and continuously driving a complex inflammatory response. This is accompanied by smooth muscle cell proliferation and extracellular matrix synthesis, ultimately forming atherosclerotic plaques. The stability of these plaques directly determines their clinical risk; vulnerable plaques are prone to rupture and detachment, forming emboli and leading to distal cerebrovascular events. Therefore, effective lipid management is a cornerstone strategy for slowing disease progression, stabilizing or even reversing plaques, and preventing stroke. Modern medicine mainly uses statins for lipid-lowering treatment. Although the efficacy is certain, there are certain side effects such as myopathy and elevated liver enzymes, as well as drug resistance.

[0003] Traditional Chinese medicine (TCM) has advantages in preventing and treating atherosclerosis and dyslipidemia through multi-target and holistic regulation. In TCM theory, atherosclerosis is often categorized under "phlegm turbidity," "blood stasis," and "pulse obstruction," with the core pathogenesis often being a deficiency of the root and an excess of the branch, namely, qi deficiency and yin deficiency as the root, and phlegm turbidity and blood stasis as the branch. Therefore, treatment should follow the principle of tonifying qi and nourishing yin to treat the root cause, and promoting blood circulation, removing blood stasis, clearing phlegm, and unblocking the meridians to treat the branch. The classic formula Bazhen Tang (composed of ginseng, atractylodes macrocephala, poria cocos, licorice, angelica sinensis, white peony root, chuanxiong rhizome, and rehmannia root) embodies the TCM principle of "strengthening the body's resistance to eliminate pathogens and consolidating the foundation to clear the source." It addresses the root cause by invigorating the spleen and tonifying qi, nourishing yin and blood, and promoting blood circulation. Its potential mechanisms of action may include improving blood rheology, regulating immune inflammatory responses, protecting vascular endothelium, and promoting hematopoiesis, providing a TCM approach to the prevention and treatment of atherosclerosis.

[0004] However, using Bazhen Decoction alone to treat existing carotid atherosclerotic plaques has significant limitations and drawbacks: 1) Insufficient efficacy in eliminating pathogenic factors and weak targeting: This formula excels at tonifying and strengthening the body, but it only contains Chuanxiong, a blood-activating herb with mild medicinal properties. It lacks strong blood-activating, stasis-removing, phlegm-resolving, and turbidity-reducing herbs, thus limiting its direct effect on the existing "phlegm-stasis" pathogenic factors (i.e., plaques). 2) The formula is too nourishing and may impede the stomach: The formula contains Rehmannia glutinosa, Angelica sinensis, and other herbs that are rich and nourishing, which can easily hinder the spleen and stomach's digestive function. For patients with common spleen deficiency and dampness, and phlegm-turbidity obstruction, it may aggravate symptoms such as abdominal distension and loss of appetite, which is not conducive to eliminating "phlegm-dampness". 3) Limited applicability to certain syndrome types: This formula is warming and tonifying. For patients with concurrent liver yang hyperactivity (such as hypertension) or excessive internal heat (significant inflammatory response), it may have the disadvantage of "adding fuel to the fire", leading to adverse reactions. 4) Relatively slow onset of action: As a tonic and conditioning agent, its onset speed and therapeutic intensity are often insufficient for patients who need to quickly stabilize plaques and prevent acute events.

[0005] In summary, current Western medicine treatments carry the risk of side effects, while traditional Chinese medicine formulas such as Bazhen Tang (Eight-Treasure Decoction) have the advantage of holistic regulation, but their specificity in "eliminating pathogens" from atherosclerotic plaques, the balance of medicinal properties, and the speed of onset of action still need optimization. Therefore, there is an urgent need to develop new treatment plans that are more targeted, balance strengthening the body's resistance with powerfully eliminating pathogens, and are easy for patients to adhere to long-term, while inheriting the holistic view and the essence of syndrome differentiation and treatment in traditional Chinese medicine. Summary of the Invention

[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing a traditional Chinese medicine composition and its preparation method that have the effects of lowering blood lipids and resisting carotid atherosclerotic plaques.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows: The first aspect is to provide a traditional Chinese medicine composition with lipid-lowering and anti-carotid atherosclerotic plaque effects, comprising the following components in parts by weight: American ginseng 50-70 parts, Astragalus membranaceus 250-350 parts, Ganoderma lucidum 50-70 parts, saffron extract 20-40 parts, snow lotus culture 25-30 parts, donkey-hide gelatin 110-130 parts, Angelica sinensis 90-110 parts, Rehmannia glutinosa 115-125 parts, and peach kernel 100-1 20 parts, hawthorn 140-160 parts, cassia seed 60-120 parts, lotus leaf 80-100 parts, mulberry leaf 90-120 parts, dandelion 145-155 parts, Japanese raisin tree fruit 85-95 parts, kudzu root 145-155 parts, Solomon's seal 100-150 parts, poria cocos 200-250 parts, coix seed 300-350 parts, tangerine peel 85-95 parts, amomum villosum 55-65 parts, and prepared licorice root 55-65 parts.

[0008] Furthermore, the traditional Chinese medicine composition comprises the following components in parts by weight: 60 parts American ginseng, 300 parts Astragalus membranaceus, 60 parts Ganoderma lucidum, 30 parts saffron extract, 30 parts snow lotus culture, 120 parts donkey-hide gelatin, 100 parts Angelica sinensis, 120 parts Rehmannia glutinosa, 100 parts peach kernel, 150 parts hawthorn, 90 parts cassia seed, 90 parts lotus leaf, 90 parts mulberry leaf, 150 parts dandelion, 90 parts Japanese raisin tree fruit, 150 parts kudzu root, 150 parts Polygonatum odoratum, 200 parts Poria cocos, 300 parts coix seed, 90 parts tangerine peel, 60 parts Amomum villosum, and 60 parts prepared licorice root.

[0009] Furthermore, the traditional Chinese medicine composition comprises the following components in parts by weight: 60 parts American ginseng, 300 parts Astragalus membranaceus, 60 parts Ganoderma lucidum, 40 parts saffron extract, 30 parts snow lotus culture, 120 parts donkey-hide gelatin, 100 parts Angelica sinensis, 120 parts Rehmannia glutinosa, 120 parts peach kernel, 150 parts hawthorn, 90 parts cassia seed, 90 parts lotus leaf, 90 parts mulberry leaf, 150 parts dandelion, 90 parts Japanese raisin tree fruit, 150 parts kudzu root, 100 parts Polygonatum odoratum, 200 parts Poria cocos, 300 parts coix seed, 90 parts tangerine peel, 60 parts Amomum villosum, and 60 parts prepared licorice root.

[0010] Furthermore, the traditional Chinese medicine composition also includes 90 parts by weight of Atractylodes lancea; and 60 parts of American ginseng, 300 parts of Astragalus membranaceus, 60 parts of Ganoderma lucidum, 30 parts of saffron extract, 30 parts of snow lotus culture, 120 parts of donkey-hide gelatin, 100 parts of Angelica sinensis, 120 parts of Rehmannia glutinosa, 120 parts of peach kernel, 150 parts of hawthorn, 60 parts of cassia seed, 90 parts of lotus leaf, 90 parts of mulberry leaf, 150 parts of dandelion, 90 parts of Hovenia dulcis, 150 parts of kudzu root, 100 parts of Polygonatum odoratum, 250 parts of Poria cocos, 350 parts of coix seed, 90 parts of tangerine peel, 60 parts of Amomum villosum, and 60 parts of prepared licorice root.

[0011] Furthermore, the traditional Chinese medicine composition also includes 90 parts by weight of gardenia; and 60 parts of American ginseng, 250 parts of astragalus, 60 parts of ganoderma, 30 parts of saffron extract, 30 parts of snow lotus culture, 120 parts of donkey-hide gelatin, 100 parts of angelica, 120 parts of prepared rehmannia root, 120 parts of peach kernel, 150 parts of hawthorn, 120 parts of cassia seed, 90 parts of lotus leaf, 120 parts of mulberry leaf, 150 parts of dandelion, 90 parts of raisin tree fruit, 90 parts of gardenia, 150 parts of kudzu root, 150 parts of polygonatum rhizome, 200 parts of poria cocos, 300 parts of coix seed, 90 parts of tangerine peel, 60 parts of amomum villosum, and 60 parts of prepared licorice root.

[0012] The second aspect is to provide a method for preparing the above-mentioned traditional Chinese medicine composition into a paste, including the following steps: S1, Raw material pretreatment: Make donkey-hide gelatin into donkey-hide gelatin beads, and stir-fry hawthorn; S2, Soaking: Mix all ingredients except saffron extract, cardamom powder, donkey-hide gelatin beads and isomaltooligosaccharide, and soak in water for 6-9 hours; S3, Decoction and Filtration: The soaked material is decocted multiple times, the decoctions obtained from each decoction are combined and filtered to obtain a combined decoction. S4, Concentration: Concentrate the combined medicinal liquid to a thick paste with a relative density of 1.10-1.20 (55℃), add saffron extract, cardamom powder, donkey-hide gelatin beads and isomaltooligosaccharide, and simmer over low heat until the paste reaches the "hanging flag" state.

[0013] Furthermore, in step S2, the amount of water added is 8-12 times the total weight of the raw materials.

[0014] Furthermore, in step S3, the multiple decoctions are three decoctions and three filtrations, specifically: the first decoction is brought to a boil over high heat and then kept simmering over low heat for 2-3 hours; the second decoction is made by adding 6-8 times the amount of water and simmering over low heat for 1.5-2 hours; the third decoction is made by adding 4-6 times the amount of water and simmering over low heat for 1-1.5 hours.

[0015] Furthermore, in step S4, the concentration process employs low-temperature vacuum concentration, with the temperature controlled at 60-70℃.

[0016] Furthermore, in step S4, before adding the saffron extract, cardamom powder, donkey-hide gelatin beads and isomaltooligosaccharide, the thick paste is first subjected to ultrafiltration or high-speed centrifugation.

[0017] The present invention adopts the above technical solution and has the following technical effects compared with the prior art: The herbal ointment of this invention is innovatively modified based on the "Eight Treasures Decoction" (the original formula of the Eight Treasures Decoction consists of ginseng, atractylodes macrocephala, poria cocos, licorice, angelica sinensis, white peony root, chuanxiong rhizome, and prepared rehmannia root). Inheriting the core (strengthening the body's resistance): American ginseng is used instead of ginseng to enhance the effect of nourishing both qi and yin, without causing excessive tonification, making it more suitable for modern constitutions. Poria, prepared licorice, angelica, and prepared rehmannia are retained in Bazhen Decoction, forming the basis of the whole formula for nourishing qi and blood.

[0018] 2) Key Strengthening (Invigorating Qi and Promoting Blood Circulation) Enhanced Qi Tonification: The heavy use of Astragalus membranaceus, in synergy with American ginseng, greatly replenishes vital energy, invigorates Qi and promotes blood circulation, significantly enhancing the Qi-tonifying efficacy of the original formula "Sijunzi Decoction".

[0019] Enhanced Blood Circulation: Given that carotid atherosclerosis is primarily characterized by "blood stasis," the pungent and dispersing properties of Chuanxiong are removed and replaced with saffron extract, peach kernel, and hawthorn, which have stronger blood-activating and detoxifying effects. These three herbs form a powerful combination for activating blood circulation and removing blood stasis, directly targeting the core pathological symptom of "blood stasis." Hawthorn also has the effects of promoting digestion and lowering lipids.

[0020] Enhanced Qi and Blood Circulation: Astragalus combined with Angelica sinensis in the original formula transforms it into the traditional famous formula Dang Gui Bu Xue Tang (Angelica Blood-Nourishing Decoction), which is known for its ability to invigorate Qi and promote blood circulation, thus enhancing its ability to invigorate Qi and promote blood circulation.

[0021] 3) Other functions (resolving phlegm and clearing turbidity while strengthening the spleen and stomach) Targeted Expansion (Phlegm Resolving and Turbidity Reducing): In response to the "phlegm turbidity" in dyslipidemia, an innovative combination of herbs including cassia seed, lotus leaf, mulberry leaf, dandelion, and Japanese raisin tree seed has been added. This combination of herbs clears heat, resolves phlegm, reduces lipids, and eliminates turbidity is not found in the original Bazhen Decoction and directly addresses the pathology of modern diseases.

[0022] Overall Harmony (Spleen Strengthening and Preparation): Adding Amomum villosum and Citrus peel to regulate Qi and strengthen the spleen, preventing greasy and cloying substances from hindering the stomach; using maltodextrin to thicken the paste, which has the modern functions of flavoring, shaping, and prebiotic regulation of intestinal flora.

[0023] 4) This formula omits the astringent properties of white peony root because its need for promoting blood circulation and unblocking collaterals outweighs the need for astringent and yin-tonifying effects. It also omits atractylodes macrocephala because this formula already heavily uses poria cocos and coix seed to strengthen the spleen and eliminate dampness, and the addition of astragalus membranaceus to strengthen the spleen qi already covers and surpasses the effects of atractylodes macrocephala. This formula precisely targets the pathogenesis and employs rigorous logical combinations: it strictly adheres to the principles of "strengthening the body's resistance and eliminating pathogenic factors" and "treating phlegm and blood stasis simultaneously," with a clearly defined structure. It uses the Bazhen Decoction as a foundation to "strengthen the body's resistance" and a group of blood-activating and phlegm-resolving herbs to "eliminate pathogenic factors," thus forming a complete therapeutic loop targeting the pathogenesis of carotid atherosclerosis characterized by "deficiency of both qi and blood, and mutual binding of phlegm and blood stasis."

[0024] Enhanced synergistic effect and better expected results: Compared with the traditional Bazhen Decoction, this formula not only replenishes qi and blood, but also greatly enhances the ability to resolve pathological products. It is expected to have more significant comprehensive advantages in lowering blood lipids, improving vascular inflammation and blood rheology. Detailed Implementation

[0025] The present invention will be further described below with reference to specific embodiments, but these are not intended to limit the invention. It should be noted that, unless otherwise specified, the embodiments and features described in the embodiments of the present invention can be combined with each other.

[0026] Example 1 This embodiment provides a traditional Chinese medicine composition with lipid-lowering and anti-carotid atherosclerotic plaque effects. The specific formula is as follows: American ginseng 60g, Astragalus membranaceus 300g, Ganoderma lucidum 60g, saffron extract 30g, snow lotus culture 30g, donkey-hide gelatin 120g, Angelica sinensis 100g, Rehmannia glutinosa 120g, peach kernel 100g, hawthorn 150g, cassia seed 90g, lotus leaf 90g, mulberry leaf 90g, dandelion 150g, Japanese raisin tree fruit 90g, kudzu root 150g, Polygonatum odoratum 150g, Poria cocos 200g, coix seed 300g, tangerine peel 90g, amomum villosum 60g, and prepared licorice root 60g.

[0027] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition into a paste, including the following steps: (1) Selection and inspection of medicinal materials All medicinal materials are selected to meet the standards stipulated in the Chinese Pharmacopoeia. Authentic medicinal materials from preferred regions are used; for example, Astragalus membranaceus is selected from Shanxi or Inner Mongolia, Angelica sinensis from Gansu, and Poria cocos from Yunnan. All medicinal materials are inspected before being stored to ensure they are free of impurities and mold.

[0028] (2) Processing of medicinal materials The following pretreatments are performed on some medicinal materials: Place the donkey-hide gelatin blocks in talcum powder and heat until the surface puffs up and becomes crisp, or crush them into coarse particles to make donkey-hide gelatin beads. Take clean hawthorn berries, remove the pits, place them in a stir-frying container, and stir-fry over low heat until the surface turns dark brown; then remove and let cool.

[0029] The remaining medicinal materials are cleaned and selected for later use.

[0030] (3) Cleaning and soaking Except for donkey-hide gelatin, saffron extract, and cardamom, all other medicinal materials should be quickly washed with running drinking water to remove surface dust. Place the washed medicinal materials into an extraction container, add 8-12 times the total weight of the medicinal materials in purified water, and soak for 6-9 hours.

[0031] (4) Decoction and filtration The process involves three decoctions and three filtrations: First decoction: After soaking, heat directly over high heat until boiling, then reduce to low heat and simmer for 2-3 hours. Filter to obtain the first decoction.

[0032] Second decoction: Add 6-8 times the amount of purified water to the dregs, simmer over low heat for 1.5-2 hours, filter, and obtain the second decoction.

[0033] Third decoction: Add 4-6 times the amount of purified water to the dregs, simmer over low heat for 1 hour, filter, and obtain the third decoction.

[0034] Combine the three filtrates and perform coarse filtration using a filter cloth with a mesh size of 120 or higher.

[0035] (5) Concentration The combined filtrate is transferred to a concentration device, first heated to boiling over high heat, then reduced to low heat and concentrated under reduced pressure at 60-70℃, or slowly concentrated under open pressure at atmospheric pressure. Continuous stirring is maintained during concentration to prevent charring. Concentrate until the relative density of the extract, measured at 50-60℃, is 1.10-1.20.

[0036] (6) Fine filtration The concentrated extract is then filtered while still hot, using methods such as ultrafiltration or high-speed centrifugation, to remove insoluble fine impurities and obtain a clear solution.

[0037] (7) Finishing the paste Add saffron extract, cardamom powder, donkey-hide gelatin beads, and 1000g of isomaltooligosaccharide as an excipient to the filtered medicinal liquid in sequence. Heat over a low flame while continuously stirring in the same direction. Continue heating and concentrating until the paste becomes thick. When the paste is lifted by a stirring rod and slowly falls in sheets (commonly known as "hanging flag"), or when a small amount of paste is dropped into cold water and forms a round bead without spreading (commonly known as "dropping water forms a bead"), stop heating. The paste is then obtained.

[0038] Example 2 This embodiment provides another traditional Chinese medicine composition with lipid-lowering and anti-carotid atherosclerotic plaque effects. The specific formula is as follows: American ginseng 60g, Astragalus membranaceus 300g, Ganoderma lucidum 60g, saffron extract 30g, snow lotus culture 30g, donkey-hide gelatin 120g, Angelica sinensis 100g, Rehmannia glutinosa 120g, peach kernel 120g, hawthorn 150g, cassia seed 60g, lotus leaf 90g, mulberry leaf 90g, dandelion 150g, Japanese raisin tree fruit 90g, kudzu root 150g, Polygonatum odoratum 100g, Poria cocos 250g, coix seed 350g, Atractylodes lancea 90g, tangerine peel 90g, Amomum villosum 60g, and prepared licorice root 60g.

[0039] Preparation process: Same as in Example 1.

[0040] Features: Suitable for patients with hyperlipidemia accompanied by carotid artery plaques and diagnosed with spleen deficiency and dampness, and prominent symptoms of phlegm obstruction. Common symptoms include obesity, sticky stools, and thick, greasy tongue coating.

[0041] Example 3 This embodiment provides another traditional Chinese medicine composition with lipid-lowering and anti-carotid atherosclerotic plaque effects. The specific formula is as follows: American ginseng 60g, Astragalus membranaceus 300g, Ganoderma lucidum 60g, saffron extract 40g, snow lotus culture 30g, donkey-hide gelatin 120g, Angelica sinensis 100g, Rehmannia glutinosa 120g, peach kernel 120g, hawthorn 150g, cassia seed 90g, lotus leaf 90g, mulberry leaf 90g, dandelion 150g, Japanese raisin tree fruit 90g, kudzu root 150g, Polygonatum odoratum 100g, Poria cocos 200g, coix seed 300g, tangerine peel 90g, amomum villosum 60g, and prepared licorice root 60g.

[0042] Preparation process: Same as in Example 1.

[0043] Features: Suitable for patients with hyperlipidemia accompanied by carotid artery plaques and diagnosed with more obvious blood stasis syndrome, such as those with chest tightness and stabbing pain, and a purplish-dark tongue.

[0044] Example 4 This embodiment provides another traditional Chinese medicine composition with lipid-lowering and anti-carotid atherosclerotic plaque effects. The specific formula is as follows: American ginseng 60g, Astragalus membranaceus 250g, Ganoderma lucidum 60g, saffron extract 30g, snow lotus culture 30g, donkey-hide gelatin 120g, Angelica sinensis 100g, Rehmannia glutinosa 120g, peach kernel 120g, hawthorn 150g, cassia seed 120g, lotus leaf 90g, mulberry leaf 120g, dandelion 150g, Japanese raisin tree fruit 90g, gardenia 90g, kudzu root 150g, Polygonatum odoratum 150g, Poria cocos 200g, coix seed 300g, tangerine peel 90g, amomum villosum 60g, prepared licorice root 60g, and isomaltooligosaccharide 1000g.

[0045] Preparation process: Same as in Example 1.

[0046] Features: Suitable for those with hyperlipidemia accompanied by carotid artery plaques and liver yang hyperactivity and liver fire, often accompanied by hypertension, dizziness, and red face and eyes.

[0047] Clinical Case 1 Mr. Mou, a 70-year-old patient from Zhangdian District, Zibo City, Shandong Province, was diagnosed with carotid artery plaques during a routine health check. He had previously taken aspirin and atorvastatin, but the treatment was ineffective. Carotid ultrasound showed symmetrical diameters of the bilateral common carotid, internal, and external carotid arteries, with uneven thickening of the intima-media layer. Multiple plaques were visible on the left side, the largest measuring 3.6*1.6mm, exhibiting hyperechoic appearance. Multiple plaques were also visible on the right side, the largest measuring 8.08*3.26mm, exhibiting hypoechoic appearance.

[0048] Intervention plan: Take the ointment prepared in Example 1. The method of use is to take 15 ml twice a day, morning and evening, either directly swallowed or mixed with 100-200 ml of warm water.

[0049] Carotid ultrasound was performed again 28 days after taking the medication. Multiple plaques were visible on the left side, the largest measuring 3.18*1.6mm, and were isoechoic; multiple plaques were visible on the right side, the largest measuring 4.68*1.7mm, and were hypoechoic.

[0050] Clinical Case 2 Mr. Wang, a 69-year-old patient from Zhoucun District, Zibo City, Shandong Province, was diagnosed with carotid artery plaques during a routine health check. He had previously taken clopidogrel and ezetimibe tablets, but the treatment was ineffective. Carotid ultrasound showed symmetrical diameters of the bilateral common carotid, internal, and external carotid arteries, with uneven thickening of the intima-media layer. A single plaque measuring 6.52*1.62mm was visible on the left side, which was either hypoechoic or anechoic; a single plaque measuring 8.96*1.82mm was visible on the right side, which was also either hypoechoic or anechoic.

[0051] Intervention plan: Take the ointment prepared in Example 1. The method of use is to take 15 ml twice a day, morning and evening, either directly swallowed or mixed with 100-200 ml of warm water.

[0052] Carotid ultrasound was performed again 28 days after taking the medication. The diameters of the bilateral common carotid arteries, internal carotid arteries, and external carotid arteries were symmetrical; the intima-media layer on the left side was unevenly thickened, with the thickest point located at the bifurcation of the common carotid artery, measuring approximately 1.3 mm; the intima-media layer on the right side was also unevenly thickened, with a single plaque measuring 7.7*1.6 mm, which was isoechoic.

[0053] Clinical Case 3 Patient Ms. Li, 72 years old, from Kuiwen District, Weifang, Shandong Province, presented with transient dizziness. Examination revealed a large plaque in her right carotid artery. She had a history of hypercholesterolemia and was taking rosuvastatin, but experienced recurring dizziness. Traditional Chinese Medicine (TCM) diagnosis: The patient's long-term excessive consumption of rich and fatty foods damaged her spleen, leading to impaired digestion and internal retention of dampness, hence the symptoms of obesity, thick tongue coating, and weak pulse. The diagnosis was spleen deficiency with dampness accumulation. Carotid ultrasound showed: Left side: 1.3mm thickening of the intima-media layer of the carotid artery, without any clearly defined plaque. Right side: A single large plaque measuring 9.5mm × 2.3mm was visible on the posterior wall of the common carotid artery bifurcation. It was a hypoechoic (soft plaque) causing mild stenosis of the lumen.

[0054] Intervention plan: Take the paste prepared in Example 2. The method of use is to take 15 ml twice a day, morning and evening, either directly swallowed or mixed with 100-200 ml of warm water.

[0055] A follow-up carotid ultrasound was performed 28 days after the initial treatment. The ultrasound showed: Left side: Mild intima-media thickening of approximately 1.1 mm, with no clearly defined plaque. Right side: The previously large plaque had significantly shrunk to 7.8 mm × 1.8 mm, and the echogenicity changed from hypoechoic to iso- to slightly hyperechoic.

[0056] Clinical Case 4 Patient Ms. Ji, 66 years old, from Erqi District, Zhengzhou, Henan Province. She presented with transient dizziness, and examination revealed a large plaque in her right carotid artery. She had a history of hypercholesterolemia and had been taking rosuvastatin (10mg / day) for a long time, but her lipid levels were not well controlled, and she experienced recurring dizziness. Traditional Chinese Medicine (TCM) diagnosis: The patient presented with abdominal obesity, loose stools, a thick, greasy tongue coating, and a slow pulse, indicating spleen deficiency and impaired transport function, leading to internal retention of dampness and turbidity. The TCM diagnosis was spleen deficiency with excessive dampness. Carotid ultrasound: Left side: Intima-media thickening of the carotid artery (1.3mm), no clearly defined plaque. Right side: A single large plaque measuring 9.5mm × 2.3mm was visible on the posterior wall of the common carotid artery bifurcation; it was hypoechoic (soft plaque), causing mild stenosis of the lumen. Blood lipid profile (fasting morning test): Total cholesterol (TC) 5.98 mmol / L; Triglycerides (TG) 2.51 mmol / L; Low-density lipoprotein cholesterol (LDL-C) 3.89 mmol / L; High-density lipoprotein cholesterol (HDL-C) 1.05 mmol / L.

[0057] Intervention plan: Take the paste prepared in Example 2. The method of use is to take 15 ml twice a day, morning and evening, either directly swallowed or mixed with 100-200 ml of warm water.

[0058] Carotid ultrasound: Left side: Carotid intima-media thickening reduced to 1.1 mm, no formed plaques observed. Right side: The original large plaque significantly shrank to 7.8 mm × 1.8 mm (length reduced by 17.9%, thickness reduced by 21.7%), the echogenicity changed from hypoechoic to isoechoic to slightly hyperechoic, and plaque stability significantly improved; waist circumference slightly decreased, weight slightly reduced; lipid profile: total cholesterol (TC) decreased to 4.90 mmol / L (18.1% decrease); triglycerides (TG) decreased to 1.72 mmol / L (31.5% decrease); low-density lipoprotein cholesterol (LDL-C) decreased to 2.95 mmol / L (24.2% decrease); high-density lipoprotein cholesterol (HDL-C) remained stable at 1.08 mmol / L (slightly increased).

[0059] Clinical Case 5 Mr. Wang, a 68-year-old patient from Lixia District, Jinan, Shandong Province, had a 10-year history of hypertension. A routine physical examination revealed carotid artery plaques. He had previously taken antihypertensive medication and atorvastatin calcium tablets (20mg / day) for a long time, and his blood lipids were relatively well controlled, but the carotid artery plaques persisted. Traditional Chinese Medicine (TCM) diagnosis: The patient reported chest tightness, a purplish-dark tongue, and a choppy pulse, indicating poor blood circulation and stagnation of blood vessels, classifying the condition as blood stasis. Carotid ultrasound showed diffuse thickening of the intima-media layer in both carotid arteries. Left side: Multiple plaques were visible, the largest of which was located at the carotid bifurcation, measuring 5.4mm × 2.1mm, and exhibiting mixed echogenicity. Right side: Scattered plaques were visible, the largest of which measured 7.2mm × 1.9mm and exhibited hypoechoicity.

[0060] Intervention plan: Take the paste prepared in Example 3. The method of use is to take 15 ml twice a day, morning and evening, either directly swallowed or mixed with 100-200 ml of warm water.

[0061] A follow-up carotid ultrasound was performed 28 days after the initial treatment. The ultrasound showed: Left side: The largest plaque had shrunk to 4.8mm × 1.7mm, and the echogenicity had changed from mixed echo to predominantly isoechoic. Right side: The largest plaque had significantly shrunk to 6.0mm × 1.6mm, and the echogenicity had changed from hypoechoic to isoechoic.

[0062] Clinical Case 6 Mr. Zhang, 68 years old, from Guancheng District, Zhengzhou, Henan Province, presented with a carotid artery plaque discovered during a physical examination over two years prior. He has a history of hypertension and hyperlipidemia, and has been taking atorvastatin (20mg / day) and antihypertensive medication long-term. Recent follow-up blood lipid tests showed that his lipid levels remained below target, and he occasionally experienced chest tightness. Traditional Chinese Medicine (TCM) diagnosis: The patient's lips and nails were purplish-dark, sublingual veins were prominent, and the pulse was wiry and hesitant, indicating poor blood circulation and blood stasis, classifying the condition as blood stasis syndrome. Carotid ultrasound: Left side: A mixed echogenic plaque measuring 7.2mm × 2.0mm was visible at the bifurcation of the common carotid artery. Right side: Thickening of the intima-media layer of the carotid artery (1.2mm). Blood lipid profile: Total cholesterol (TC) 6.25 mmol / L; Triglycerides (TG) 1.95 mmol / L; Low-density lipoprotein cholesterol (LDL-C) 4.02 mmol / L; High-density lipoprotein cholesterol (HDL-C) 1.02 mmol / L.

[0063] Intervention plan: Take the paste prepared in Example 3. The method of use is to take 15 ml twice a day, morning and evening, either directly swallowed or mixed with 100-200 ml of warm water.

[0064] After 28 days of treatment, a carotid ultrasound and four lipid profile tests (fasting morning test) were performed. Carotid ultrasound: Left side: Plaque size shrank to 6.1mm × 1.7mm (length reduced by 15.3%, thickness reduced by 15.0%), echogenicity became more homogeneous, and isoechoic components increased. Right side: Carotid intima-media thickening (1.2mm), size unchanged. Four lipid profile tests: Total cholesterol (TC) decreased to 5.18mmol / L (17.1% decrease); triglycerides (TG) decreased to 1.45mmol / L (25.6% decrease); low-density lipoprotein cholesterol (LDL-C) decreased to 3.15mmol / L (21.6% decrease); high-density lipoprotein cholesterol (HDL-C) increased to 1.15mmol / L (12.7% increase).

[0065] Clinical Case 7 Mr. Wang, a 65-year-old patient from Jinshui District, Zhengzhou, Henan Province, presented with transient blurred vision and was found to have bilateral carotid artery plaques. He has a history of diabetes, taking metformin, and dyslipidemia but is not taking lipid-lowering drugs. Traditional Chinese Medicine (TCM) diagnosis: The patient presented with dizziness, headache, flushed face and red eyes, a red tongue, and a wiry and forceful pulse, indicating liver and kidney yin deficiency with liver yang hyperactivity, classifying the condition as liver yang hyperactivity. Carotid ultrasound: Left side: A hypoechoic plaque measuring 10.1mm × 2.5mm was visible in the carotid bulb, with approximately 30% luminal stenosis. Right side: A hyperechoic plaque measuring 4.5mm × 1.5mm was found on the posterior wall of the common carotid artery. The four lipid profiles were as follows: total cholesterol (TC) 5.82 mmol / L; triglycerides (TG) 3.02 mmol / L (significantly elevated); low-density lipoprotein cholesterol (LDL-C) 3.45 mmol / L; high-density lipoprotein cholesterol (HDL-C) 0.91 mmol / L.

[0066] Intervention plan: Take the paste prepared in Example 4. The method of use is to take 15 ml twice a day, morning and evening, either directly swallowed or mixed with 100-200 ml of warm water.

[0067] After 28 days of treatment, a carotid ultrasound and four lipid profile tests (fasting morning test) were performed. Carotid ultrasound: Left side: The large hypoechoic plaque shrank to 8.5mm × 2.0mm (length reduced by 15.8%, thickness reduced by 20.0%), with increased echogenicity, transitioning to isoechoic to hypoechoic. Right side: Plaque size remained stable, with no change in echogenicity. Four lipid profile tests: Total cholesterol (TC) decreased to 4.95 mmol / L (a decrease of 14.9%); triglycerides (TG) decreased significantly to 1.98 mmol / L (a decrease of 34.4%); low-density lipoprotein cholesterol (LDL-C) decreased to 2.85 mmol / L (a decrease of 17.4%); high-density lipoprotein cholesterol (HDL-C) increased to 1.01 mmol / L (an increase of 11.0%).

[0068] Clinical Case 8 Patient Ms. Zhao, 70 years old, from Jinshui District, Zhengzhou, Henan Province, has a 5-year history of coronary heart disease and 1 year post-stent placement. She regularly takes aspirin, clopidogrel, and rosuvastatin (10mg / day). Carotid ultrasound still shows plaque progression, raising concerns about recurrent cardiovascular events. Traditional Chinese Medicine (TCM) diagnosis: The patient is habitually irritable and easily angered, accompanied by headache and tinnitus, red tongue with little coating, wiry and rapid pulse, scanty dark urine, and constipation. This is due to deficiency of liver and kidney yin, with excessive liver yang and internal disturbance of heat, diagnosed as liver yang hyperactivity. Carotid ultrasound: Left side: 1.1mm thickening of the intima-media layer of the common carotid artery. Right side: An isoechoic plaque measuring 6.8mm × 1.9mm is visible at the dilated area. Blood lipid profile: Total cholesterol (TC) 5.15 mmol / L; Triglycerides (TG) 1.88 mmol / L; Low-density lipoprotein cholesterol (LDL-C) 3.05 mmol / L (not meeting the guideline recommended very low target); High-density lipoprotein cholesterol (HDL-C) 1.10 mmol / L.

[0069] Intervention plan: Take the paste prepared in Example 4. The method of use is to take 15 ml twice a day, morning and evening, either directly swallowed or mixed with 100-200 ml of warm water.

[0070] After 28 days of treatment, a carotid ultrasound and four lipid profile tests were performed (fasting morning test). Carotid ultrasound: Left side: Intima-media thickening of the common carotid artery was 1.1 mm. (No significant change) Right side: The isoechoic plaque size decreased to 5.9 mm × 1.6 mm (length decreased by 13.2%, thickness decreased by 15.8%). Four lipid profile tests: Total cholesterol (TC) decreased to 4.40 mmol / L (a decrease of 14.6%); triglycerides (TG) decreased to 1.50 mmol / L (a decrease of 20.2%); low-density lipoprotein cholesterol (LDL-C) decreased to 2.45 mmol / L (a decrease of 19.7%), approaching the target value; high-density lipoprotein cholesterol (HDL-C) remained stable at 1.12 mmol / L.

[0071] The above description is merely a preferred embodiment of the present invention and does not limit the implementation and protection scope of the present invention. Those skilled in the art should realize that any equivalent substitutions and obvious changes made based on the content of the present invention specification should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition having a blood lipid-lowering and anti-carotid atherosclerotic plaque effect, characterized in that, The Chinese medicine composition comprises the following components in parts by weight: American ginseng 50-70 parts, radix astragali 250-350 parts, lucid ganoderma 50-70 parts, saffron extract 20-40 parts, saussurea culture 25-30 parts, donkey-hide gelatin 110-130 parts, angelica 90-110 parts, prepared rehmannia 115-125 parts, peach kernel 100-120 parts, hawthorn 140-160 parts, cassia seed 60-120 parts, lotus leaf 80-100 parts, mulberry leaf 90-120 parts, dandelion 145-155 parts, jujube 85-95 parts, kudzu vine 145-155 parts, polygonatum 100-150 parts, hoelen 200-250 parts, coix seed 300-350 parts, orange peel 85-95 parts, amomum 55-65 parts, and fried licorice 55-65 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The Chinese medicine composition comprises the following components in parts by weight: American ginseng 60 parts, radix astragali 300 parts, lucid ganoderma 60 parts, saffron extract 30 parts, saussurea culture 30 parts, donkey-hide gelatin 120 parts, angelica 100 parts, prepared rehmannia 120 parts, peach kernel 100 parts, hawthorn 150 parts, cassia seed 90 parts, lotus leaf 90 parts, mulberry leaf 90 parts, dandelion 150 parts, jujube 90 parts, kudzu vine 150 parts, polygonatum 150 parts, hoelen 200 parts, coix seed 300 parts, orange peel 90 parts, amomum 60 parts, and fried licorice 60 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The Chinese medicine composition comprises the following components in parts by weight: American ginseng 60 parts, radix astragali 300 parts, lucid ganoderma 60 parts, saffron extract 40 parts, saussurea culture 30 parts, donkey-hide gelatin 120 parts, angelica 100 parts, prepared rehmannia 120 parts, peach kernel 120 parts, hawthorn 150 parts, cassia seed 90 parts, lotus leaf 90 parts, mulberry leaf 90 parts, dandelion 150 parts, jujube 90 parts, kudzu vine 150 parts, polygonatum 100 parts, hoelen 200 parts, coix seed 300 parts, orange peel 90 parts, amomum 60 parts, and fried licorice 60 parts.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The Chinese medicine composition further comprises 90 parts by weight of atractylodes; and, American ginseng 60 parts, radix astragali 300 parts, lucid ganoderma 60 parts, saffron extract 30 parts, saussurea culture 30 parts, donkey-hide gelatin 120 parts, angelica 100 parts, prepared rehmannia 120 parts, peach kernel 120 parts, hawthorn 150 parts, cassia seed 60 parts, lotus leaf 90 parts, mulberry leaf 90 parts, dandelion 150 parts, jujube 90 parts, kudzu vine 150 parts, polygonatum 100 parts, hoelen 250 parts, coix seed 350 parts, orange peel 90 parts, amomum 60 parts, and fried licorice 60 parts.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The Chinese medicine composition further comprises 90 parts by weight of gardenia; and, American ginseng 60 parts, radix astragali 250 parts, lucid ganoderma 60 parts, saffron extract 30 parts, saussurea culture 30 parts, donkey-hide gelatin 120 parts, angelica 100 parts, prepared rehmannia 120 parts, peach kernel 120 parts, hawthorn 150 parts, cassia seed 120 parts, lotus leaf 90 parts, mulberry leaf 120 parts, dandelion 150 parts, jujube 90 parts, gardenia 90 parts, kudzu vine 150 parts, polygonatum 150 parts, hoelen 200 parts, coix seed 300 parts, orange peel 90 parts, amomum 60 parts, and fried licorice 60 parts.

6. A method for preparing the paste of the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, The method comprises the following steps: S1, raw material pretreatment: prepare donkey-hide gelatin into donkey-hide gelatin beads, and roast hawthorn; S2, soaking: mix the raw materials except saffron extract, amomum villosum powder, donkey-hide gelatin beads and isomaltooligosaccharide, and soak in water for 6-9 hours; S3, decocting and filtering: decoct the soaked material for multiple times, combine the medicinal liquid obtained from each decocting, and filter to obtain combined medicinal liquid; S4, concentrating: concentrate the combined medicinal liquid to thick paste with relative density of 1.10-1.20 (55℃), add saffron extract, amomum villosum powder, donkey-hide gelatin beads and isomaltooligosaccharide, and collect the paste to "flag" state on low heat.

7. The production method according to claim 6, wherein In step S2, the amount of water added is 8-12 times of the total weight of raw materials.

8. The preparation method according to claim 6, characterized in that, In step S3, the multiple decocting is three decocting and three filtering, specifically: the first decocting is boiled on strong heat and then kept on low heat for 2-3 hours; the second decocting is added with 6-8 times of water and decocted on low heat for 1.5-2 hours; the third decocting is added with 4-6 times of water and decocted on low heat for 1-1.5 hours.

9. The preparation method according to claim 6, characterized in that, In step S4, the concentration process adopts low-temperature and reduced-pressure concentration, and the temperature is controlled at 60-70℃.

10. The method of claim 6, wherein, In step S4, before adding the saffron extract, amomum villosum powder, donkey-hide gelatin beads and isomaltooligosaccharide, the thick paste is treated by ultrafiltration or high-speed centrifugation.