Traditional Chinese medicine compound for treating carotid atherosclerosis and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine compound for treating carotid atherosclerosis and a preparation method thereof. The traditional Chinese medicine compound comprises the following components: cassia twig, radix paeoniae rubra, poria cocos, moutan bark, peach kernel, rhizoma atractylodis, trichosanthes kirilowii maxim, radix curcumae, oyster and earthworm. According to the traditional Chinese medicine, phlegm reducing, blood stasis removing and collateral dredging are taken as the treatment principle, in the formula, moutan bark and peach kernels promote blood circulation to remove blood stasis, radix curcumae promote qi to activate blood, red peony roots clear heat to cool blood, earthworms for promoting blood circulation and activating collaterals, trichosanthes kirilowii maxim clear heat and remove phlegm, oysters calm the liver and induce astringency, rhizoma atractylodis and poria cocos are combined for tonifying spleen and eliminating dampness, and cassia twigs warm and dredge meridians and collaterals. The traditional Chinese medicine compound for treating carotid atherosclerosis has the advantages of definite curative effect, few toxic and side effects and good clinical application value.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine compound for treating carotid atherosclerosis and its preparation method. Background Technology

[0002] Atherosclerosis is a common systemic disease, and its incidence and mortality rates are increasing year by year in my country. The degree of carotid atherosclerosis reflects the damage to important blood vessels, and its pathogenesis is relatively superficial, making it easy to monitor. Rupture and detachment of unstable carotid plaques are important factors causing cardiovascular and cerebrovascular events such as stroke or acute myocardial infarction. Timely and effective measures to prevent and treat carotid atherosclerosis are of great significance in preventing the occurrence of cardiovascular and cerebrovascular events.

[0003] Traditional Chinese medicine does not have a specific disease name corresponding to carotid atherosclerosis. Modern physicians, based on the clinical manifestations of carotid atherosclerosis, classify it as "dizziness," "headache," "stroke," and "palpitation," among others. Some physicians, based on the location and pathological mechanism of the lesions, categorize it under "pulse obstruction," "blood obstruction," and "pulse turbidity." The *Ling Shu* (Spiritual Pivot), in its chapter on "Decisive Qi," states that the pulse "obstructs the flow of nutritive qi, leaving it nowhere to escape." The pulse in traditional Chinese medicine corresponds to the vascular system in modern medicine, and the two share similarities in morphology and pathogenesis. Professor Wu Yiling, based on the identity of the "pulse-vascular system," proposed the concept of "pulse-vascular system disease." Traditional Chinese medicine theory holds that carotid atherosclerosis is caused by factors such as emotional imbalance, improper diet, overwork, and prolonged illness leading to deficiency. Disorders of the internal organs' qi mechanism, yin-yang imbalance, and damage to the body's vital energy easily lead to metabolic disorders in the "pulse-vascular system," causing stagnation of qi in the collaterals, resulting in abnormal blood flow and the accumulation of turbid qi in the blood, manifesting as "blood turbidity."

[0004] Carotid atherosclerotic plaques are tangible pathogenic factors in the blood vessels and are closely related to blood stasis. Through observation of coagulation function indicators in patients with coronary heart disease and blood stasis syndrome, Zhang Wantong et al. found that these patients exhibited excessive activation of coagulation factors, resulting in hypercoagulability and hypofibrinolysis, indicating a correlation between blood stasis and coagulation function. Some researchers also believe that blood stasis is both a pathological product and a pathogenic factor of carotid atherosclerosis; blood stasis obstructing the collaterals is not only the initiating factor of carotid atherosclerosis but also plays a role throughout the entire pathogenesis of carotid atherosclerosis.

[0005] Currently, medical treatment for carotid atherosclerosis mainly includes the use of statins, antiplatelet drugs, and antioxidants. For patients with severe stenosis of the blood vessels, surgical treatment is recommended. All these treatments have certain adverse reactions, such as inducing elevated liver enzymes, causing bleeding, or damaging blood vessels. In recent years, traditional Chinese medicine has also been increasingly used in the treatment of carotid atherosclerosis. Compared with Western medicine, it has the advantages of fewer side effects and higher safety.

[0006] Since the causes and symptoms of carotid atherosclerosis vary, and different traditional Chinese medicines have different focuses of efficacy, more traditional Chinese medicines for treating carotid atherosclerosis still need to be developed in order to better address different types of diseases. Summary of the Invention

[0007] In view of this, the present invention provides a traditional Chinese medicine compound for treating carotid atherosclerosis and its preparation method.

[0008] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine compound for treating carotid atherosclerosis.

[0009] The present invention also provides the application of the above-mentioned traditional Chinese medicine compound for treating carotid atherosclerosis in the preparation of drugs for treating carotid atherosclerosis.

[0010] The technical solution adopted by the present invention to achieve the above objectives is as follows: In a first aspect, the present invention provides a traditional Chinese medicine compound for treating carotid atherosclerosis, the traditional Chinese medicine compound comprising the following components: cinnamon twig, red peony root, poria cocos, peony bark, peach kernel, atractylodes lancea, trichosanthes fruit, turmeric, oyster shell, and earthworm.

[0011] As some preferred technical solutions of the present invention, the following components are contained in parts by weight: 7-11 parts of cinnamon twig, 12-18 parts of red peony root, 12-18 parts of poria cocos, 10-15 parts of peony bark, 7-11 parts of peach kernel, 10-15 parts of atractylodes lancea, 12-18 parts of trichosanthes fruit, 12-18 parts of turmeric, 25-35 parts of oyster shell, and 7-11 parts of earthworm.

[0012] As a preferred technical solution of the present invention, the following components are contained in parts by weight: 9 parts of cinnamon twig, 15 parts of red peony root, 15 parts of poria cocos, 12 parts of peony bark, 9 parts of peach kernel, 12 parts of atractylodes lancea, 15 parts of trichosanthes fruit, 15 parts of turmeric, 30 parts of oyster shell, and 9 parts of earthworm.

[0013] As a preferred technical solution of the present invention, the following components are contained by weight: 7 parts of cinnamon twig, 18 parts of red peony root, 12 parts of poria cocos, 10 parts of peony bark, 11 parts of peach kernel, 10 parts of atractylodes lancea, 15 parts of trichosanthes fruit, 12 parts of turmeric, 30 parts of oyster shell, and 11 parts of earthworm.

[0014] As a preferred technical solution of the present invention, the following components are contained by weight: 9 parts of cinnamon twig, 12 parts of red peony root, 15 parts of poria cocos, 12 parts of peony bark, 9 parts of peach kernel, 12 parts of atractylodes lancea, 12 parts of trichosanthes fruit, 15 parts of turmeric, 35 parts of oyster shell, and 9 parts of earthworm.

[0015] In a second aspect, the present invention provides a pharmaceutical preparation for treating carotid atherosclerosis, characterized in that the pharmaceutical preparation comprises the effective components of the above-mentioned traditional Chinese medicine compound.

[0016] As a preferred embodiment of the present invention, the pharmaceutical preparation further includes excipients.

[0017] As a preferred embodiment of the present invention, the dosage form of the pharmaceutical preparation is granules, tablets, capsules, or decoction.

[0018] A third aspect of the present invention provides a method for preparing a traditional Chinese medicine compound for treating carotid atherosclerosis, comprising the following steps: extracting the above-mentioned traditional Chinese medicine compound with water to obtain an aqueous extract; and preparing the aqueous extract into a dosage form of the pharmaceutical preparation.

[0019] As a preferred technical solution of the present invention, the water extraction step includes: decocting the traditional Chinese medicine compound with water at least twice, each time for 0.5-1.5 hours, filtering after each decoction, and combining the filtrates to obtain the water extract.

[0020] The herbal compound is decocted in water at least twice (e.g., twice, three times, four times, or five times), each time for 0.5-1.5 hours (e.g., 0.5 hours, 1 hour, or 1.5 hours). After each decoction, the mixture is filtered, and the filtrates are combined to obtain the aqueous extract.

[0021] As a preferred technical solution of the present invention, in the water extraction step, the decoction is performed twice. In the first decoction, the mass of water is 8-10 times the mass of the Chinese herbal medicine compound, and the decoction time is 1-1.5 hours. In the second decoction, the mass of water is 6-8 times the mass of the Chinese herbal medicine compound, and the decoction time is 0.5 hours to 1 hour.

[0022] As a preferred embodiment of the present invention, in the water extraction step, the decoction is performed twice. In the first decoction, the mass of water is 8-10 times the mass of the traditional Chinese medicine compound (e.g., 8, 9, or 10 times), and the decoction time is 1-1.5 hours (e.g., 0.5 hours, 1 hour, or 1.5 hours). In the second decoction, the mass of water is 6-8 times the mass of the traditional Chinese medicine compound (e.g., 6, 7, or 8 times), and the decoction time is 0.5 hours to 1 hour (e.g., 0.5 hours or 1 hour).

[0023] A fourth aspect of the present invention provides the use of the aforementioned traditional Chinese medicine compound in the preparation of a drug for the prevention or treatment of carotid atherosclerosis.

[0024] The beneficial effects of the traditional Chinese medicine compound formula for treating carotid atherosclerosis in this invention are as follows: This invention takes resolving phlegm, removing blood stasis, and unblocking the meridians as its treatment principle. In the formula, peony bark and peach kernel promote blood circulation and remove blood stasis, turmeric promotes qi and blood circulation, red peony clears heat and cools blood, earthworm, a substance with blood and flesh, unblocks the meridians, trichosanthes fruit clears heat and eliminates phlegm, oyster shell calms the liver and astringes, atractylodes and poria are used together to strengthen the spleen and dry dampness, and cinnamon twig warms and unblocks the meridians.

[0025] Pharmacodynamic experiments showed that the traditional Chinese medicine compound of this invention significantly reduced serum TC, TG, and LDL-C levels, increased serum HDL-C levels, reduced total plaque area / total arterial area, and effectively improved the related symptoms of carotid atherosclerosis.

[0026] The traditional Chinese medicine compound of this invention has a definite curative effect in treating carotid atherosclerosis, with few toxic side effects, and has good clinical application value. Attached Figure Description

[0027] Figure 1 Comparison of serum TC levels in rats of different groups with the blank control. & P <0.05, && P <0.01; compared with the model control group, P <0.05, P <0.01; compared with Experimental Group 1, # P <0.05, ## P <0.01.

[0028] Figure 2 Comparison of serum TG levels in rats of different groups with the blank control. & P <0.05, && P <0.01; compared with the model control group, P <0.05, P <0.01; compared with Experimental Group 1, # P <0.05, ## P <0.01.

[0029] Figure 3 Comparison of serum LDL-C levels in rats of different groups with the blank control. & P <0.05, && P <0.01; compared with the model control group, P <0.05, P <0.01; compared with Experimental Group 1, # P <0.05, ## P <0.01.

[0030] Figure 4 Comparison of serum HDL-C levels in rats of different groups with the blank control. & P <0.05, && P <0.01; compared with the model control group, P <0.05, P <0.01; compared with Experimental Group 1, # P <0.05.

[0031] Figure 5 Comparison of total plaque area / total arterial area in each group of rats, compared with the blank control. & P <0.05, && P <0.01; compared with the model control group, P <0.05, P <0.01; compared with Experimental Group 1, # P <0.05, ## P <0.01. Detailed Implementation

[0032] To better understand the above technical solutions, a detailed description of the specific implementation methods will be provided below. Obviously, the described embodiments are merely some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0033] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or device that includes said element.

[0034] Unless otherwise specified, all raw materials and excipients of the traditional Chinese medicine compound formula of this invention can be obtained commercially. Any traditional Chinese medicine compound formula of any range described in this invention, including the end value and any value between the end values ​​and any sub-range formed by the end value or any value between the end values, can achieve the effects described in this invention.

[0035] The term "parts by weight" in this invention specification refers to the proportion of each ingredient in the traditional Chinese medicine compound. Depending on the actual application, "1 part by weight" in this invention can be "1g", "1kg" or any other arbitrary weight.

[0036] The daily dosage of the traditional Chinese medicine compound described in this invention can be adjusted according to the patient's condition.

[0037] Example 1 This embodiment provides a traditional Chinese medicine compound for treating carotid atherosclerosis, which is composed of the following ingredients: 9 parts cinnamon twig, 15 parts red peony root, 15 parts poria cocos, 12 parts peony bark, 9 parts peach kernel, 12 parts atractylodes lancea, 15 parts trichosanthes fruit, 15 parts turmeric, 30 parts oyster shell, and 9 parts earthworm.

[0038] The preparation method of this traditional Chinese medicine compound is as follows: Weigh out cinnamon twig, red peony root, poria cocos, peony bark, peach kernel, atractylodes lancea, trichosanthes fruit, turmeric, oyster shell, and earthworm, mix them together, add water in 8 times the weight of the traditional Chinese medicine compound for the first time, decoct for 1 hour, filter to obtain filtrate, add water in 6 times the weight of the traditional Chinese medicine compound to the residue, decoct for 0.5 hours, filter to obtain filtrate, and combine the two filtrates.

[0039] Example 2 This embodiment provides a traditional Chinese medicine compound for treating carotid atherosclerosis, which is composed of the following ingredients: 7 parts cinnamon twig, 18 parts red peony root, 12 parts poria cocos, 10 parts peony bark, 11 parts peach kernel, 10 parts atractylodes lancea, 15 parts trichosanthes fruit, 12 parts turmeric, 30 parts oyster shell, and 11 parts earthworm.

[0040] The preparation method of this traditional Chinese medicine compound is as follows: Weigh out cinnamon twig, red peony root, poria cocos, peony bark, peach kernel, atractylodes lancea, trichosanthes fruit, turmeric, oyster shell, and earthworm, mix them together, add water in a volume 10 times the weight of the traditional Chinese medicine compound, decoct for 1.5 hours, filter to obtain filtrate, add water in a volume 8 times the weight of the traditional Chinese medicine compound to the residue, decoct for 1 hour, filter to obtain filtrate, and combine the two filtrates.

[0041] Example 3 This embodiment provides a traditional Chinese medicine compound for treating carotid atherosclerosis, which is composed of the following ingredients: 9 parts cinnamon twig, 12 parts red peony root, 15 parts poria cocos, 12 parts peony bark, 9 parts peach kernel, 12 parts atractylodes lancea, 12 parts trichosanthes fruit, 15 parts turmeric, 35 parts oyster shell, and 9 parts earthworm.

[0042] The preparation method of this traditional Chinese medicine compound is as follows: Weigh out cinnamon twig, red peony root, poria cocos, peony bark, peach kernel, atractylodes lancea, trichosanthes fruit, turmeric, oyster shell, and earthworm, mix them together, add water in 8 times the weight of the traditional Chinese medicine compound for the first time, decoct for 1 hour, filter to obtain filtrate, add water in 6 times the weight of the traditional Chinese medicine compound to the residue, decoct for 0.5 hours, filter to obtain filtrate, and combine the two filtrates.

[0043] Example 4 This embodiment provides a traditional Chinese medicine compound for treating carotid atherosclerosis, which is composed of the following ingredients: 11 parts cinnamon twig, 12 parts red peony root, 18 parts poria cocos, 15 parts peony bark, 7 parts peach kernel, 15 parts atractylodes lancea, 15 parts trichosanthes fruit, 18 parts turmeric, 25 parts oyster shell, and 7 parts earthworm.

[0044] The preparation method of this traditional Chinese medicine compound is as follows: Weigh out cinnamon twig, red peony root, poria cocos, peony bark, peach kernel, atractylodes lancea, trichosanthes fruit, turmeric, oyster shell, and earthworm, mix them together, add water in a volume 10 times the weight of the traditional Chinese medicine compound, decoct for 1.5 hours, filter, and obtain filtrate. Add water in a volume 6 times the weight of the traditional Chinese medicine compound to the residue, decoct for 1 hour, filter, and obtain filtrate. Combine the two filtrates.

[0045] Example 5 This embodiment provides a traditional Chinese medicine compound for treating carotid atherosclerosis, which is composed of the following ingredients: 9 parts cinnamon twig, 15 parts red peony root, 18 parts poria cocos, 12 parts peony bark, 9 parts peach kernel, 12 parts atractylodes lancea, 18 parts trichosanthes fruit, 15 parts turmeric, 30 parts oyster shell, and 9 parts earthworm.

[0046] The preparation method of this traditional Chinese medicine compound is as follows: Weigh out cinnamon twig, red peony root, poria cocos, peony bark, peach kernel, atractylodes lancea, trichosanthes fruit, turmeric, oyster shell, and earthworm, mix them together, add water in a volume 8 times the weight of the traditional Chinese medicine compound for the first time, decoct for 1.5 hours, filter to obtain filtrate, add water in a volume 8 times the weight of the traditional Chinese medicine compound to the residue, decoct for 1 hour, filter to obtain filtrate, and combine the two filtrates.

[0047] Example 6 This embodiment provides a traditional Chinese medicine compound for treating carotid atherosclerosis, which is composed of the following ingredients: 11 parts cinnamon twig, 18 parts red peony root, 15 parts poria cocos, 15 parts peony bark, 7 parts peach kernel, 15 parts atractylodes lancea, 15 parts trichosanthes fruit, 18 parts turmeric, 25 parts oyster shell, and 7 parts earthworm.

[0048] The preparation method of this traditional Chinese medicine compound is as follows: Weigh out cinnamon twig, red peony root, poria cocos, peony bark, peach kernel, atractylodes lancea, trichosanthes fruit, turmeric, oyster shell, and earthworm, mix them together, add water in a volume 10 times the weight of the traditional Chinese medicine compound, decoct for 1 hour, filter, and obtain filtrate. Add water in a volume 8 times the weight of the traditional Chinese medicine compound to the residue, decoct for 1 hour, filter, and obtain filtrate. Combine the two filtrates.

[0049] Example 7 This embodiment provides a traditional Chinese medicine compound for treating carotid atherosclerosis, which is composed of the following ingredients: 9 parts cinnamon twig, 15 parts red peony root, 12 parts poria cocos, 12 parts peony bark, 9 parts peach kernel, 12 parts atractylodes lancea, 18 parts trichosanthes fruit, 12 parts turmeric, 30 parts oyster shell, and 9 parts earthworm.

[0050] The preparation method of this traditional Chinese medicine compound is as follows: Weigh out cinnamon twig, red peony root, poria cocos, peony bark, peach kernel, atractylodes lancea, trichosanthes fruit, turmeric, oyster shell, and earthworm, mix them together, add water in 8 times the weight of the traditional Chinese medicine compound for the first time, decoct for 1 hour, filter to obtain filtrate, add water in 6 times the weight of the traditional Chinese medicine compound to the residue, decoct for 0.5 hours, filter to obtain filtrate, and combine the two filtrates.

[0051] Comparative Example 1 Cinnamon twig 9 parts, red peony root 15 parts, poria cocos 15 parts, peach kernel 9 parts, atractylodes lancea 12 parts, trichosanthes fruit 15 parts, turmeric 15 parts, oyster shell 30 parts, earthworm 9 parts.

[0052] The only difference between this comparative example and Example 1 is that the peony bark component is not used in the specific formulation.

[0053] Comparative Example 2 Cinnamon twig 9 parts, Poria cocos 15 parts, Moutan bark 12 parts, Peach kernel 9 parts, Atractylodes lancea 12 parts, Trichosanthes kirilowii 15 parts, Curcuma longa 15 parts, Oyster shell 30 parts, Earthworm 9 parts.

[0054] The only difference between this comparative example and Example 1 is that the component of Paeonia lactiflora is not used in the specific formulation.

[0055] Comparative Example 3 Cinnamon twig 9 parts, red peony root 15 parts, poria cocos 15 parts, peony bark 12 parts, peach kernel 9 parts, atractylodes lancea 12 parts, trichosanthes fruit 15 parts, styrax 15 parts, oyster shell 30 parts, earthworm 9 parts.

[0056] The only difference between this comparative example and Example 1 is that turmeric is replaced with styrax in the specific formulation.

[0057] Comparative Example 4 Cinnamon twig 9 parts, red peony root 15 parts, poria cocos 15 parts, peony bark 12 parts, peach kernel 9 parts, atractylodes lancea 12 parts, trichosanthes fruit 15 parts, turmeric 15 parts, oyster shell 30 parts, earthworm 9 parts.

[0058] The only difference between this comparative example and Example 1 is that Asarum is used instead of Cinnamon Twig in the specific formulation.

[0059] Comparative Example 5 Cinnamon twig 15 parts, red peony root 10 parts, poria cocos 10 parts, peony bark 18 parts, peach kernel 6 parts, atractylodes rhizome 8 parts, trichosanthes fruit 10 parts, turmeric 10 parts, oyster shell 20 parts, earthworm 5 parts.

[0060] The only difference between this comparative example and Example 1 is that the amount of the components in the formulation is changed.

[0061] Prepared according to the method in Example 1.

[0062] Experimental study of the effects of the traditional Chinese medicine compound of this invention on rats with carotid atherosclerosis. 1. Experimental Methods Sixty 8-week-old SPF-grade male SD rats, weighing 180-220g, were used. The rats were allowed free access to food and water and were acclimatized for 7 days before being randomly divided into a blank control group and a model group.

[0063] Rats in the model group were injected with 32 mg / kg bovine serum albumin via the tail vein and 2.5 mg / kg ovalbumin via intraperitoneal injection, once every 3 days for a total of 5 times, and fed a high-fat diet. One week later, they were given a single gavage injection of 250,000 U / kg vitamin D3 with 25 mg / 100 mL ferrous sulfate added to their drinking water, twice a day, and their drinking water, body weight, appearance, and activity were observed.

[0064] After successful modeling, the rats were randomly divided into four groups according to their body weight: model control group, treatment group 1, treatment group 2, treatment group 3, treatment group 4, treatment group 5, treatment group 6, treatment group 7, and treatment group 8, with 6 rats in each group.

[0065] Group 1 was administered the following medications by gavage: Example 1 (14.1 g / kg, calculated as crude drug); Group 2 was administered the following medications by gavage: Example 2 (14.1 g / kg, calculated as crude drug); Group 3 was administered the following medications by gavage: Example 3 (14.1 g / kg, calculated as crude drug); Group 4 was administered the following medications by gavage: Comparative Example 1 (14.1 g / kg, calculated as crude drug); Group 5 was administered the following medications by gavage: Comparative Example 2 (14.1 g / kg, calculated as crude drug); Group 6 was administered the following medications by gavage: Comparative Example 3 (14.1 g / kg, calculated as crude drug); Group 7 was administered the following medications by gavage: Comparative Example 4 (14.1 g / kg, calculated as crude drug); and Group 8 was administered the following medications by gavage: Comparative Example 5 (14.1 g / kg, calculated as crude drug).

[0066] Rats in the blank control group and the model control group were administered an equal volume of distilled water by gavage. Each group of rats was given the drug once daily for 4 consecutive weeks.

[0067] 2. Indicator Testing Serum biochemical markers detection Blood samples were collected from rats before sacrifice, centrifuged at 3000 rpm for 5 min, and serum was separated. Then, TC, LDL-C, HDL-C, and TG were detected by biochemical analysis.

[0068] HE staining for carotid artery pathology The common carotid artery was embedded in paraffin and cut into 4µm thick sections, then stained with hematoxylin and eosin (HE) to observe the pathological changes in the common carotid artery. The plaque area and total arterial area were measured using an image analyzer, and the changes in the ratio of total plaque area to total arterial area were statistically analyzed.

[0069] 3. Statistical Methods Statistical analysis was performed using GraphPad Prism 8 software. All data are expressed as mean ± standard deviation. Statistical significance was determined by t-test and one-way ANOVA. P < 0.05 was considered statistically significant.

[0070] 4. Experimental Results 4.1 Comparison of blood lipid levels in rats of different groups Table 1 Comparison of blood lipid levels in rats of different groups Note: Compared with the blank control, & P <0.05, && P <0.01; compared with the model control group, P <0.05, P <0.01; compared with group 1, # P <0.05, ## P <0.01.

[0071] Compared with the blank control group, the serum TC, TG and LDL-C levels of rats in the model control group were significantly increased, while the HDL-C level was significantly decreased.

[0072] Compared with the model control group, treatment groups 1, 2, and 3 significantly reduced serum TC, TG, and LDL-C levels, and increased HDL-C levels. Compared with treatment groups 4-8, treatment groups 1, 2, and 3 had lower serum TC, TG, and LDL-C levels and higher HDL-C levels. The results indicate that the traditional Chinese medicine compound of this invention has a certain restorative effect on blood lipid levels in rats with a carotid atherosclerosis model. The results are shown in Table 1. Figures 1-4 .

[0073] 4.2 Comparison of total plaque area / total arterial area among different groups of rats Compared with the blank control group, the total plaque area / total arterial area of ​​rats in the model control group was significantly increased.

[0074] Compared with the model control group, the total plaque area / total arterial area of ​​rats in treatment groups 1, 2, and 3 was significantly reduced. Compared with treatment groups 4-8, the total plaque area / total arterial area of ​​rats in treatment groups 1, 2, and 3 was significantly reduced. Results are shown below. Figure 5 .

[0075] In summary, the traditional Chinese medicine compound of this invention significantly reduces serum TC, TG, and LDL-C levels, increases serum HDL-C levels, reduces total plaque area / total arterial area, and effectively improves the related symptoms of carotid atherosclerosis.

[0076] The efficacy of the traditional Chinese medicine compound formulas in Examples 1-3 and Comparative Examples 1-5 was measured. It was found that Examples 1-3 showed a more significant effect in treating carotid atherosclerosis compared with Comparative Examples 1-5.

[0077] Further analysis revealed that peony bark, red peony root, turmeric, and cinnamon twig play crucial roles in this traditional Chinese medicine compound. When these four ingredients are absent, the synergistic effect of the entire composition is weakened, resulting in a lower efficacy in treating carotid atherosclerosis and a lesser degree of symptom improvement compared to Examples 1-3, which include peony bark, red peony root, turmeric, and cinnamon twig. This indicates that peony bark, red peony root, turmeric, and cinnamon twig are indispensable components of this traditional Chinese medicine compound, playing a key role in enhancing the overall efficacy.

[0078] Comparative Example 5 had a different ratio of component dosages, and its effect on improving carotid atherosclerosis was not as good as the traditional Chinese medicine compound in Examples 1-3, suggesting that the ratio of component dosages can affect the efficacy of the formulation.

[0079] The preferred embodiments of the present invention have been described in detail above, but the present invention is not limited to the embodiments described. Those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of the present invention, and these equivalent modifications or substitutions are all included within the scope defined by the claims of this application.

Claims

1. A traditional Chinese medicine compound for treating carotid atherosclerosis, characterized in that, The traditional Chinese medicine compound contains the following components: 7-11 parts of cinnamon twig, 12-18 parts of red peony root, 12-18 parts of poria cocos, 10-15 parts of peony bark, 7-11 parts of peach kernel, 10-15 parts of atractylodes lancea, 12-18 parts of trichosanthes fruit, 12-18 parts of turmeric, 25-35 parts of oyster shell, and 7-11 parts of earthworm.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine compound contains the following components by weight: 9 parts cinnamon twig, 15 parts red peony root, 15 parts poria cocos, 12 parts peony bark, 9 parts peach kernel, 12 parts atractylodes lancea, 15 parts trichosanthes fruit, 15 parts turmeric, 30 parts oyster shell, and 9 parts earthworm.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine compound contains the following components by weight: 7 parts cinnamon twig, 18 parts red peony root, 12 parts poria cocos, 10 parts peony bark, 11 parts peach kernel, 10 parts atractylodes lancea, 15 parts trichosanthes fruit, 12 parts turmeric, 30 parts oyster shell, and 11 parts earthworm.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine compound contains the following components by weight: 9 parts cinnamon twig, 12 parts red peony root, 15 parts poria cocos, 12 parts peony bark, 9 parts peach kernel, 12 parts atractylodes lancea, 12 parts trichosanthes fruit, 15 parts turmeric, 35 parts oyster shell, and 9 parts earthworm.

5. A pharmaceutical preparation for treating carotid atherosclerosis, characterized by, The pharmaceutical preparation contains the effective components of the above-mentioned traditional Chinese medicine compound.

6. The pharmaceutical preparation according to claim 4, characterized in that, The pharmaceutical preparation also includes excipients.

7. The pharmaceutical preparation according to claim 5 or 6, characterized in that, The dosage form of the pharmaceutical preparation is granules, tablets, capsules, or decoction.

8. A process for the preparation of a pharmaceutical preparation as claimed in any one of claims 5 to 7, characterized in that, The preparation method includes the following steps: extracting the traditional Chinese medicine compound according to any one of claims 1-4 with water to obtain an aqueous extract; and preparing the aqueous extract into the dosage form of the pharmaceutical preparation.

9. The preparation method according to claim 8, characterized in that, The water extraction step includes: decocting the traditional Chinese medicine compound with water at least twice, each time for 0.5-1.5 hours, filtering after each decoction, and combining the filtrates to obtain the water extract.

10. The use of the traditional Chinese medicine compound according to any one of claims 1-4 in the preparation of drugs for the prevention or treatment of carotid atherosclerosis.

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