Traditional Chinese medicine composition for treating atherosclerosis as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating atherosclerosis and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of vinegar turtle shell, 5-15 parts of immature bitter orange, 5-15 parts of vinegar rhizoma sparganii, 2-10 parts of arisaema cum bile, 5-15 parts of vinegar curcuma zedoary, 20-40 parts of raw oyster, 10-20 parts of radix fici simplicissimae and 5-15 parts of semen brassicae. The weight ratio of the vinegar turtle to the raw oyster to the radix fici simplicissimae is (1: 1)-(4: 1); the weight ratio of the immature bitter orange to the arisaema cum bile to the semen brassicae is (5: 1)-(4: 5). Compared with the prior art, the pharmaceutical composition has a better treatment effect on atherosclerosis, can effectively reduce the drug administration dosage, and has the advantages of low cost and better safety.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine. Specifically, it relates to a traditional Chinese medicine composition for treating atherosclerosis, its preparation method and application. Background Art

[0002] The incidence of atherosclerosis is very high and it affects the arterial blood vessels throughout the body, mainly involving the aorta, coronary arteries, cerebral arteries, renal arteries, and large and medium-sized muscular elastic arteries. Eventually, it leads to stenosis or even complete blockage of their lumens, causing ischemia, hypoxia, dysfunction of important organs and even death of the body.

[0003] Traditional Chinese medicine believes that lipid metabolism disorders, lipid deposition in vascular endothelial cells, lead to the internal binding of qi, blood, phlegm and stasis, which lingers and accumulates, causing the formation of internal masses and leading to atherosclerosis. The softening and resolving mass formula consists of turtle shell, sanleng (Rhizoma Sparganii), ezhu (Rhizoma Curcumae), immature bitter orange, prepared bile-starwort and dendrobium. This prescription first achieved the prevention and treatment of atherosclerosis through the method of softening and resolving masses.

[0004] Literature reports (Deng Zhigang et al., Clinical observation on the treatment of carotid atherosclerosis with the softening and resolving mass formula [J], Chinese Clinical Research, 2012, 4(10), 19 - 20) show that the softening and resolving mass formula can effectively reduce blood lipids and reverse carotid atherosclerotic plaques, and has good clinical applications. Chinese Patent CN109700972A discloses a traditional Chinese medicine composition, its preparation method and application. The above traditional Chinese medicine composition includes the following components: turtle shell, sanleng (Rhizoma Sparganii), ezhu (Rhizoma Curcumae), immature bitter orange, prepared bile-starwort and dendrobium; the preparation method of the traditional Chinese medicine composition includes the following steps: taking part of sanleng (Rhizoma Sparganii) and part of ezhu (Rhizoma Curcumae), pulverizing them into fine powder, sieving to obtain the first powder; mixing turtle shell, immature bitter orange, prepared bile-starwort, dendrobium and the remaining sanleng (Rhizoma Sparganii) and ezhu (Rhizoma Curcumae), adding water for heat reflux extraction, filtering the extraction solution, concentrating the filtrate into a paste, and then pulverizing it into fine powder to obtain the second powder; mixing the first powder and the second powder, and adding excipients to make the required dosage form. The traditional Chinese medicine composition of this invention has good therapeutic effects on arteriosclerosis, cerebral infarction, coronary heart disease, hyperlipidemia and fatty liver.

[0005] Although the softening and resolving mass formula currently has good clinical applications, its cost is high and there is still room for improvement in its efficacy. Therefore, there is an urgent need to develop a traditional Chinese medicine composition with lower cost and better efficacy. Summary of the Invention

[0006] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine composition for treating atherosclerosis, its preparation method and application. Through the improvement of raw materials and preparation methods, the prepared traditional Chinese medicine composition significantly improves the therapeutic effect on atherosclerosis, effectively reduces the production cost, and provides more choices for clinical applications.

[0007] In order to achieve the above object, the present invention adopts the following technical solutions: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating atherosclerosis, which is made from the following raw materials in parts by weight: 10-20 parts of stir-fried turtle shell, 5-15 parts of immature bitter orange, 5-15 parts of stir-fried rhizoma sparganii, 2-10 parts of arisaema cum bile, 5-15 parts of stir-fried rhizoma zedoariae, 20-40 parts of raw oyster, 10-20 parts of ficus hirta, and 5-15 parts of white mustard seed.

[0008] In some embodiments, the weight ratio of the stir-fried turtle shell, raw oyster, and ficus hirta is 1:1-4:1; preferably 1:2-3:1; more preferably 1:2:1.

[0009] In some embodiments, the weight ratio of the immature bitter orange, arisaema cum bile, and white mustard seed is 5:1-4:5; preferably 5:1-3:5; more preferably 5:3:5.

[0010] In some embodiments, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-20 parts of stir-fried turtle shell, 5-15 parts of immature bitter orange, 5-15 parts of stir-fried rhizoma sparganii, 2-10 parts of arisaema cum bile, 5-15 parts of stir-fried rhizoma zedoariae, 20-40 parts of raw oyster, 10-20 parts of ficus hirta, and 5-15 parts of white mustard seed; the weight ratio of the stir-fried turtle shell, raw oyster, and ficus hirta is 1:2:1; the weight ratio of the immature bitter orange, arisaema cum bile, and white mustard seed is 5:3:5.

[0011] In some embodiments, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts of stir-fried turtle shell, 10 parts of immature bitter orange, 10 parts of stir-fried rhizoma sparganii, 6 parts of arisaema cum bile, 10 parts of stir-fried rhizoma zedoariae, 30 parts of raw oyster, 15 parts of ficus hirta, and 10 parts of white mustard seed.

[0012] In a second aspect, the present invention provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: (1) Extracting the white mustard seed and immature bitter orange in the formula amount to obtain volatile oil; (2) Performing water extraction on the stir-fried turtle shell, raw oyster, and ficus hirta in the formula amount, separating the solid and liquid to obtain a water extract; (3) Performing alcohol extraction on the stir-fried rhizoma sparganii, stir-fried rhizoma zedoariae, and arisaema cum bile in the formula amount, separating the solid and liquid to obtain an alcohol extract; (4) Combining the water extract obtained in step (2) and the alcohol extract obtained in step (3), concentrating and drying, and then mixing with the volatile oil obtained in step (1) to obtain the product.

[0013] In some embodiments, the extraction in step (1) is steam distillation method, specifically: the amount of water used in the extraction is 15-20 times the total weight of the white mustard seed and immature bitter orange, and the distillation time is 60 min - 120 min.

[0014] In some embodiments, the water extraction in step (2) is as follows: decocting with water for at least 1 time, 30 min - 90 min each time; specifically, the amount of water added is 12 - 18 times the total weight of turtle shell medicated with vinegar, raw oyster and radix ficuses hirtae.

[0015] In some embodiments, the ethanol extraction in step (3) is as follows: extracting with ethanol with a volume fraction of 30% - 50% for at least 1 time, 30 min - 90 min each time; specifically, the amount of ethanol added is 10 - 15 times the total weight of rhizoma sparganii medicated with vinegar, rhizoma zedoariae medicated with vinegar and arisaema cum bile.

[0016] In some embodiments, the concentration in step (4) is carried out by vacuum concentration at 50°C - 70°C, specifically: vacuum concentrating (-0.08 to -0.09 MPa) at 50°C - 70°C to a relative density of 1.18 - 1.20.

[0017] The solid-liquid separation mentioned in the present invention is a conventional technical means in the art, aiming to separate solids and liquids. Therefore, the present invention does not limit its specific implementation manners, and centrifugation, filtration or pressure filtration can be selected according to actual needs.

[0018] In a third aspect, the present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating atherosclerosis.

[0019] In a fourth aspect, the present invention also provides a medicament for treating atherosclerosis, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0020] Preferably, the dosage form of the medicament includes liquid preparation, tablets, pills, capsules, granules or powders.

[0021] The beneficial effects of the present invention are as follows: (1) The traditional Chinese medicine composition of the present invention is prepared by the combination of turtle shell medicated with vinegar, raw oyster and radix ficuses hirtae and immature bitter orange, arisaema cum bile and white mustard seed. Compared with the prior art, the present invention has a better therapeutic effect on atherosclerosis.

[0022] (2) By adjusting the preparation method, the present invention can maximize the exertion of the efficacy of each component in the traditional Chinese medicine composition, providing a guarantee for the realization of the efficacy.

[0023] (3) Compared with the prior art, the traditional Chinese medicine composition of the present invention has a better curative effect, can effectively reduce the dosage of the medicament, and has the advantages of low cost and better safety.

[0024] (4) The preparation method of the traditional Chinese medicine composition of the present invention is simple and low in cost, and is suitable for large-scale popularization and application. Detailed implementation manners

[0025] The following description of the embodiments is only for helping to understand the method of the present invention and its core idea. It should be noted that for those of ordinary skill in the art of this technology, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention. The following description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but can be applied to a wider range that conforms to the principles and novel features disclosed herein. Although any methods and materials similar or equivalent to those described in the present invention can be used in the implementation or testing of the present invention, the preferred methods and materials are listed herein.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs.

[0027] The multiple amount described in the present invention is relative to the raw materials. For example, in Example 1, 18 times the amount of water means that the added amount of water is 18 times the total mass of white mustard seed and immature bitter orange; 15 times the amount of water means that the added amount of water is 15 times the total mass of turtle shell (vinegar processed), raw oyster and ficus hirta; 12 times the volume of 40% ethanol by volume means that the added amount of 40% ethanol by volume is 12 times the total weight of rhizoma sparganii (vinegar processed), rhizoma zedoariae (vinegar processed) and arisaema cum bile.

[0028] Example 1 A traditional Chinese medicine composition for treating atherosclerosis is made from the following raw materials in parts by weight: 15 parts of turtle shell (vinegar processed), 10 parts of immature bitter orange, 10 parts of rhizoma sparganii (vinegar processed), 6 parts of arisaema cum bile, 10 parts of rhizoma zedoariae (vinegar processed), 30 parts of raw oyster, 15 parts of ficus hirta and 10 parts of white mustard seed.

[0029] The preparation method is as follows: (1) Take the formulated amounts of white mustard seed and immature bitter orange, add 18 times the amount of water and distill and extract for 90 minutes to obtain volatile oil; (2) Take the formulated amounts of turtle shell (vinegar processed), raw oyster and ficus hirta, add 15 times the amount of water and decoct for 60 minutes, filter to obtain a water extract; (3) Take the formulated amounts of rhizoma sparganii (vinegar processed), rhizoma zedoariae (vinegar processed) and arisaema cum bile, add 12 times the volume of 40% ethanol by volume and reflux and extract for 60 minutes, filter to obtain an ethanol extract; (4) Combine the water extract obtained in step (2) and the ethanol extract obtained in step (3), concentrate under reduced pressure (-0.08 MPa) at 60 °C to a relative density of 1.18 - 1.20, and then mix with the volatile oil obtained in step (1) to obtain the product.

[0030] Example 2 A traditional Chinese medicine composition for treating atherosclerosis is prepared from the following raw materials in parts by weight: 10 parts of stir-fried turtle shell with vinegar, 5 parts of immature bitter orange, 5 parts of rhizoma sparganii with vinegar, 2 parts of arisaema cum bile, 5 parts of rhizoma zedoariae with vinegar, 20 parts of raw oyster, 10 parts of ficus hirta, and 5 parts of white mustard seed.

[0031] The preparation method is as follows: (1) Take the formula amount of white mustard seed and immature bitter orange, add 15 times the amount of water and distill for 60 minutes to obtain volatile oil; (2) Take the formula amount of stir-fried turtle shell with vinegar, raw oyster, and ficus hirta, decoct with water 3 times, each time adding 12 times the amount of water and decocting for 30 minutes, filter, and combine the filtrates to obtain a water extract; (3) Take the formula amount of rhizoma sparganii with vinegar, rhizoma zedoariae with vinegar, and arisaema cum bile, reflux extract with ethanol 2 times, each time adding 10 times the amount of 40% ethanol by volume and reflux extracting for 30 minutes, filter, and combine the filtrates to obtain an ethanol extract; (4) Combine the water extract obtained in step (2) and the ethanol extract obtained in step (3), concentrate under reduced pressure (-0.09 MPa) at 50 °C to a relative density of 1.18 - 1.20, and then mix with the volatile oil obtained in step (1) to obtain the product.

[0032] Example 3 A traditional Chinese medicine composition for treating atherosclerosis is prepared from the following raw materials in parts by weight: 20 parts of stir-fried turtle shell with vinegar, 15 parts of immature bitter orange, 15 parts of rhizoma sparganii with vinegar, 10 parts of arisaema cum bile, 15 parts of rhizoma zedoariae with vinegar, 40 parts of raw oyster, 20 parts of ficus hirta, and 15 parts of white mustard seed.

[0033] The preparation method is as follows: (1) Take the formula amount of white mustard seed and immature bitter orange, add 20 times the amount of water and distill for 120 minutes to obtain volatile oil; (2) Take the formula amount of stir-fried turtle shell with vinegar, raw oyster, and ficus hirta, decoct with 18 times the amount of water for 90 minutes, filter, and obtain a water extract; (3) Take the formula amount of rhizoma sparganii with vinegar, rhizoma zedoariae with vinegar, and arisaema cum bile, reflux extract with ethanol 2 times, each time adding 15 times the amount of 50% ethanol by volume and reflux extracting for 30 minutes, filter, and combine the filtrates to obtain an ethanol extract; (4) Combine the water extract obtained in step (2) and the ethanol extract obtained in step (3), concentrate under reduced pressure (-0.08 MPa) at 70 °C to a relative density of 1.18 - 1.20, and then mix with the volatile oil obtained in step (1) to obtain the product.

[0034] Comparative Example 1 The difference between this comparative example and Example 1 lies in that: the weight ratios of the stir-fried turtle shell, raw oyster, and Ficus hirta Vahl are different.

[0035] Specifically, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25 parts of stir-fried turtle shell, 10 parts of immature bitter orange, 10 parts of rhizoma sparganii stir-fried with vinegar, 6 parts of arisaema cum bile, 10 parts of rhizoma zedoariae stir-fried with vinegar, 15 parts of raw oyster, 20 parts of Ficus hirta Vahl, and 10 parts of white mustard seed.

[0036] The preparation method is the same as that of Example 1.

[0037] Comparative Example 2 The difference between this comparative example and Example 1 lies in that: the weight ratios of the immature bitter orange, arisaema cum bile, and white mustard seed are different.

[0038] Specifically, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of stir-fried turtle shell, 20 parts of immature bitter orange, 10 parts of rhizoma sparganii stir-fried with vinegar, 3 parts of arisaema cum bile, 10 parts of rhizoma zedoariae stir-fried with vinegar, 30 parts of raw oyster, 15 parts of Ficus hirta Vahl, and 3 parts of white mustard seed.

[0039] The preparation method is the same as that of Example 1.

[0040] Comparative Example 3 The difference between this comparative example and Example 1 lies in that: the preparation methods are different.

[0041] The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of stir-fried turtle shell, 10 parts of immature bitter orange, 10 parts of rhizoma sparganii stir-fried with vinegar, 6 parts of arisaema cum bile, 10 parts of rhizoma zedoariae stir-fried with vinegar, 30 parts of raw oyster, 15 parts of Ficus hirta Vahl, and 10 parts of white mustard seed.

[0042] The preparation method is as follows: (1) Take the formula amounts of stir-fried turtle shell, raw oyster, white mustard seed, and immature bitter orange, add 15 times the amount of water and decoct for 60 min, filter to obtain the water extract; (2) Take the formula amounts of Ficus hirta Vahl, rhizoma sparganii stir-fried with vinegar, rhizoma zedoariae stir-fried with vinegar, and arisaema cum bile, add 12 times the volume of 40% ethanol and reflux extract for 60 min, filter to obtain the ethanol extract; (4) Combine the water extract obtained in step (1) and the ethanol extract obtained in step (2), and concentrate under reduced pressure (-0.08 MPa) at 60 °C to a relative density of 1.18 - 1.20 to obtain the product.

[0043] Comparative Example 4 This comparative example is prepared by using the formula and preparation method of the traditional Chinese medicine composition in Example 1 of Chinese Patent CN109700972A, Specifically, the traditional Chinese medicine composition is composed of the following components in parts by weight: 10 parts of stir-fried turtle shell, 5 parts of stir-fried sparganium tuber, 5 parts of stir-fried zedoary tuber, 6 parts of immature bitter orange, 3 parts of prepared arisaema cum bile and 10 parts of dendrobium officinale.

[0044] The preparation method is as follows: Take half of the stir-fried sparganium tuber and half of the stir-fried zedoary tuber, crush them into fine powder, sieve them to obtain the first powder material; Mix the stir-fried turtle shell, immature bitter orange, prepared arisaema cum bile, dendrobium officinale and the remaining stir-fried sparganium tuber and stir-fried zedoary tuber, soak them for 30 minutes, then carry out extraction by heat reflux for 4 hours, filter the extraction solution, concentrate the filtrate into a thick paste, dry the thick paste into a dry paste, and then crush it into fine powder to obtain the second powder material; Mix the first powder material and the second powder material evenly.

[0045] I. Research on the effect of the traditional Chinese medicine composition on atherosclerotic mouse models 1. Experimental materials The traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-4.

[0046] 2. Experimental animals ApoE- / - mice, male, weighing 18 g - 22 g.

[0047] 3. Experimental methods Randomly divide the mice into a blank control group, a model group, Example 1 groups - Example 3 groups and Comparative Example 1 groups - Comparative Example 4 groups according to body weight, with 8 mice in each group.

[0048] After 1 week of adaptive feeding of the mice, the blank control group is fed with a low-fat diet (LF10A, purchased from Shanghai Qifa Experimental Reagent Co., Ltd., product number D12450B), and the other groups are fed with a high-fat diet (HFHC, purchased from Shanghai Qifa Experimental Reagent Co., Ltd., product number D12079B), and continue to feed for 12 weeks to establish an atherosclerotic model, and then carry out drug intervention. Specifically: Example 1 groups - Example 3 groups: Intragastric administration of the traditional Chinese medicine compositions prepared in the corresponding examples, with the administration dose of 1 g of crude drug / kg, once a day, and the administration time is 12 weeks; Comparative Example 1 groups - Comparative Example 4 groups: Intragastric administration of the traditional Chinese medicine compositions prepared in the corresponding comparative examples, with the administration dose of 1 g of crude drug / kg, once a day, and the administration time is 12 weeks; Blank control group and model group: Intragastric administration of an equal volume of normal saline, once a day, and the administration time is 12 weeks.

[0049] After the last intragastric administration, each group fasts but does not restrict water for 12 hours, anesthetizes the mice with 3 wt% pentobarbital sodium, and takes blood by eye socket puncture.

[0050] After blood collection, cardiac perfusion was performed using normal saline: The skin and ribs of the chest cavity were cut open to expose the heart and liver; an injection needle was inserted into the left ventricle of the mouse and fixed with a hemostat, while the right auricle was cut open to allow blood to flow out, and the perfusion rate was 1 mL / min. After perfusion, the heart and aorta were removed successively. Oil red O staining of the aortic root was performed.

[0051] 4. Experimental Results 4.1 Blood lipid measurement results The blood lipid measurement results of the mice are shown in Table 1.

[0052] Table 1

[0053] Note: Compared with the model group, *P < 0.05.

[0054] The results showed that: compared with the blank control group, the serum TC and TG of the mice in the model group were significantly increased (P < 0.05). After 12 weeks of drug intervention treatment, the serum TC and TG levels of the mice in Example 1 group - Example 3 group were significantly decreased compared with the model group (P < 0.05), while the serum TC and TG levels of the mice in Comparative Example 1 group - Comparative Example 4 group were not significantly decreased compared with the model group (P > 0.05). It can be seen that compared with the prior art (Comparative Example 4 group), the traditional Chinese medicine composition prepared in Examples 1 - 3 of the present invention has a good effect of reducing the levels of TC and TG in the serum of atherosclerotic model mice. At the same time, according to Comparative Example 1 group - Comparative Example 3 group, the weight ratios of turtle shell vinegar, raw oyster and Ficus hirta, the weight ratios of immature bitter orange, bile arisaema and white mustard seed in the traditional Chinese medicine composition, as well as the specific preparation method have an important influence on the efficacy of the traditional Chinese medicine composition. Only the specific weight ratios of turtle shell vinegar, raw oyster and Ficus hirta, the specific weight ratios of immature bitter orange, bile arisaema and white mustard seed and the specific preparation method of the present invention cooperate with each other to achieve better technical effects.

[0055] 4.2 Measurement results of aortic plaque area The statistical results of the aortic oil red O staining plaque area of the mice are shown in Table 2.

[0056] Table 2

[0057] Note: Compared with the model group, *P < 0.05.

[0058] Results showed that: compared with the blank control group, after 12 weeks of feeding with a high-fat diet, obvious aortic plaques were observed in ApoE- / - mice in the model group, and the atherosclerosis model was successfully established. After 12 weeks of drug intervention treatment, the aortic plaque areas of the mice in Example 1 group - Example 3 group were significantly reduced compared with the model group (P<0.05), and the lipid droplet aggregation was significantly improved; while the aortic plaque areas of the mice in Comparative Example 1 group - Comparative Example 4 group were not significantly reduced compared with the model group (P>0.05), and the lipid droplet aggregation was not significantly improved.

[0059] It can be seen that compared with the existing technology (Comparative Example 4 group), the traditional Chinese medicine composition prepared in Examples 1 - 3 of the present invention has a better effect of reducing the plaque area. At the same time, from Comparative Example 1 group - Comparative Example 3 group, it can be known that the weight ratios of vinegar turtle shell, raw oyster and Ficus hirta, the weight ratios of immature bitter orange, bile arisaema and white mustard seed in the traditional Chinese medicine composition, and the specific preparation method have an important impact on the efficacy of the traditional Chinese medicine composition. Only the combination of the specific weight ratios of vinegar turtle shell, raw oyster and Ficus hirta, the specific weight ratios of immature bitter orange, bile arisaema and white mustard seed and the specific preparation method of the present invention can achieve better technical effects.

[0060] In summary, the atherosclerosis model induced by a high-fat diet was successfully established. After 12 weeks of treatment with the traditional Chinese medicine composition prepared in Examples 1 - 2 of the present invention, the serum total cholesterol and triglyceride contents can be significantly reduced, and the plaque area can be reduced. Compared with the existing technology, it has a better anti-atherosclerosis effect.

[0061] The above is a further description of the present invention in combination with specific embodiments, but these embodiments are merely exemplary and do not constitute any limitation to the scope of the present invention. Those skilled in the art should understand that the details and forms of the technical solutions of the present invention can be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating atherosclerosis, characterized in that, It is made from the following raw materials in parts by weight: 10 - 20 parts of stir-fried turtle shell with vinegar, 5 - 15 parts of immature bitter orange, 5 - 15 parts of rhizoma sparganii with vinegar, 2 - 10 parts of arisaema cum bile, 5 - 15 parts of rhizoma zedoariae with vinegar, 20 - 40 parts of raw oyster, 10 - 20 parts of ficus hirta, and 5 - 15 parts of white mustard seed; The weight ratio of the stir-fried turtle shell with vinegar, raw oyster, and ficus hirta is 1:1 - 4:1; The weight ratio of the immature bitter orange, arisaema cum bile, and white mustard seed is 5:1 - 4:

5.

2. The traditional Chinese medicine composition according to claim 1, wherein The weight ratio of the stir-fried turtle shell with vinegar, raw oyster, and ficus hirta is 1:2:

1.

3. The traditional Chinese medicine composition according to claim 1, wherein The weight ratio of the immature bitter orange, arisaema cum bile, and white mustard seed is 5:3:

5.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 15 parts of stir-fried turtle shell with vinegar, 10 parts of immature bitter orange, 10 parts of rhizoma sparganii with vinegar, 6 parts of arisaema cum bile, 10 parts of rhizoma zedoariae with vinegar, 30 parts of raw oyster, 15 parts of ficus hirta, and 10 parts of white mustard.

5. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, It includes the following steps: (1) Extract the white mustard seed and immature bitter orange in the formula amount to obtain volatile oil; (2) Perform water extraction on the stir-fried turtle shell with vinegar, raw oyster, and ficus hirta in the formula amount, separate the solid and liquid to obtain a water extract; (3) Perform alcohol extraction on the rhizoma sparganii with vinegar, rhizoma zedoariae with vinegar, and arisaema cum bile in the formula amount, separate the solid and liquid to obtain an alcohol extract; (4) Combine the water extract obtained in step (2) and the alcohol extract obtained in step (3), concentrate and dry, and then add the volatile oil obtained in step (1) and mix to obtain the product.

6. The preparation method according to claim 5, characterized in that, The extraction in step (1) is by steam distillation method; and / or the water extraction in step (2) is: decoct with water for at least 1 time, 30 min - 90 min each time; and / or the alcohol extraction in step (3) is: reflux extract with 30% - 50% volume fraction ethanol for at least 1 time, 30 min - 90 min each time; and / or the concentration in step (4) is vacuum concentration at 50℃ - 70℃.

7. The preparation method according to claim 6, characterized in that In the extraction in step (1), the amount of water used is 15 - 20 times the total weight of the white mustard seed and immature bitter orange, and the distillation time is 90 min - 120 min; In step (2), the amount of water added is 12 - 18 times the total weight of the stir-fried turtle shell with vinegar, raw oyster, and ficus hirta; In step (3), the amount of ethanol added is 10 - 15 times the total weight of the rhizoma sparganii with vinegar, rhizoma zedoariae with vinegar, and arisaema cum bile; The concentration in step (4) is vacuum concentration at 50 - 70℃ to a relative density of 1.18 - 1.

20.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 - 4 or the preparation method according to any one of claims 5 - 7 in the preparation of a drug for treating atherosclerosis.

9. A drug for treating atherosclerosis, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1 - 4 and pharmaceutically acceptable excipients.

10. The drug according to claim 9, characterized in that, The dosage form of the drug includes liquid preparation, tablet, pill, capsule, granule, or powder.

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