A composition for treating atherosclerotic plaques and a preparation method thereof

Abstract

The present invention relates to the technical field of traditional Chinese medicine compositions, and specifically discloses a composition for treating atherosclerotic plaques and a preparation method thereof. The technical key points are as follows: The composition is composed of the following components in parts by weight: 5-10 parts of Astragalus membranaceus, 5-10 parts of Gynostemma pentaphyllum, 5-10 parts of roasted Perilla seeds, 5-10 parts of lotus leaf, 5-10 parts of Sargassum, 7.5-20 parts of Hawthorn Fruit, 5-10 parts of Pollen Typhae, 5-10 parts of Alisma orientale, 5-10 parts of Curcuma longa, and 1.5-4 parts of Monascus purpureus. The composition of the present invention has obvious curative effects in the treatment of coronary heart disease angina pectoris, myocardial infarction, atherosclerotic plaques, and lower extremity atherosclerotic obliterans. Except for loose stools in some patients after taking the medicine, no other side effects have been found, which provides important guiding significance for the treatment of atherosclerotic plaques and the development of drugs.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and in particular, to a composition for treating atherosclerotic plaques and a preparation method thereof. Background Art

[0002] Atherosclerotic plaques are the core manifestation of atherosclerotic lesions. The main mechanisms for their formation are as follows:

[0003] 1. Lipid infiltration: Low-density lipoprotein cholesterol (LDL-C) particles in the blood enter the arterial intima. After being oxidized and modified, macrophages phagocytize these oxidized LDLs to form foam cells. The foam cells accumulate under the arterial intima, forming lipid streaks, which are the early lesions of atherosclerosis.

[0004] 2. Inflammatory response: After the formation of lipid streaks, inflammatory cells such as monocytes and T lymphocytes are recruited to the arterial intima, releasing inflammatory mediators, further promoting the formation of foam cells and the continuation of the inflammatory response, leading to vascular endothelial dysfunction, endothelial cell proliferation and migration, smooth muscle cells migrating from under the intima to the intima surface, and undergoing proliferation and phenotypic transformation, synthesizing and secreting extracellular matrix components such as collagen.

[0005] 3. Fibrous cap formation and plaque progression: Extracellular matrix components synthesized by smooth muscle cells and macrophages, such as collagen and elastin, gradually form a fibrous cap that covers the lipid core. At this time, the plaque gradually enlarges and protrudes into the lumen, resulting in vascular lumen stenosis. If the inflammatory response persists, the foam cells necrose and disintegrate, forming a necrotic core, the plaque becomes further unstable, and the fibrous cap may become thinner or even rupture.

[0006] 4. Thrombosis and complications: After the plaque ruptures, the exposed lipid core and components such as collagen will activate platelets and the coagulation system, leading to thrombosis. The thrombus may further block the blood vessel, triggering serious complications such as acute myocardial infarction and cerebral infarction.

[0007] Atherosclerotic plaques are an important pathological basis for cardiovascular and cerebrovascular diseases. Early detection and intervention are crucial for preventing serious complications. Regarding the treatment of atherosclerotic plaques, the currently clinically used drug treatments mainly include: statins, cholesterol absorption inhibitors, PCSK9 inhibitors, antiplatelet drugs, anti-inflammatory drugs, etc. At present, the components of traditional Chinese medicine compositions for treating atherosclerotic plaques are complex, the curative effects are unstable, the specific mechanisms of action have not been fully elucidated, and there is a lack of large-scale and high-quality clinical trials to verify their curative effects and safety.

[0008] Therefore, the present application aims to provide a composition for treating atherosclerotic plaques and a preparation method thereof to solve the above problems. Summary of the Invention

[0009] The object of the present invention is to solve the problems of the prior art proposed in the above background art, and to provide a composition for treating atherosclerotic plaques and a preparation method thereof.

[0010] The above object of the present invention is achieved as follows:

[0011] On the one hand, the solution of the present invention provides a composition for treating atherosclerotic plaques, and the composition is composed of the following components, by weight:

[0012] Astragalus membranaceus 5 - 10 parts, Gynostemma pentaphyllum 5 - 10 parts, roasted Perilla seed 5 - 10 parts, lotus leaf 5 - 10 parts, seaweed 5 - 10 parts, hawthorn 7.5 - 20 parts, Typha angustifolia 5 - 10 parts, Alisma orientale 5 - 10 parts, Curcuma longa 5 - 10 parts, Monascus purpureus 1.5 - 3 parts.

[0013] The solution of the present invention also provides another composition for treating atherosclerotic plaques, and the composition is composed of the following components, by weight:

[0014] Astragalus membranaceus 5 parts, Gynostemma pentaphyllum 5 parts, roasted Perilla seed 5 parts, lotus leaf 5 parts, seaweed 5 parts, hawthorn 7.5 parts, Typha angustifolia 5 parts, Alisma orientale 5 parts, Curcuma longa 5 parts, Monascus purpureus 1.5 parts.

[0015] The solution of the present invention also provides another composition for treating atherosclerotic plaques, and the composition is composed of the following components, by weight:

[0016] Astragalus membranaceus 10 parts, Gynostemma pentaphyllum 10 parts, roasted Perilla seed 10 parts, lotus leaf 10 parts, seaweed 10 parts, hawthorn 20 parts, Typha angustifolia 10 parts, Alisma orientale 10 parts, Curcuma longa 10 parts, Monascus purpureus 3 parts.

[0017] The solution of the present invention also provides another composition for treating atherosclerotic plaques, and the composition is composed of the following components, by weight:

[0018] Astragalus membranaceus 7 parts, Gynostemma pentaphyllum 7 parts, roasted Perilla seed 70 parts, lotus leaf 7 parts, seaweed 7 parts, hawthorn 15 parts, Typha angustifolia 7 parts, Alisma orientale 7 parts, Curcuma longa 7 parts, Monascus purpureus 3 parts.

[0019] Further, the composition is a decoction or a granule.

[0020] On the other hand, the solution of the present invention also provides a preparation method of a composition for treating atherosclerotic plaques, including the following steps:

[0021] S1. Weigh the following traditional Chinese medicines according to the weight ratio for standby: 5 - 10 parts of Astragalus membranaceus, 5 - 10 parts of Gynostemma pentaphyllum, 5 - 10 parts of roasted Perilla seed, 5 - 10 parts of Lotus leaf, 5 - 10 parts of Sargassum, 7.5 - 20 parts of Hawthorn fruit, 5 - 10 parts of Pollen typhae, 5 - 10 parts of Alisma orientale, 5 - 10 parts of Curcuma longa, 1.5 - 3 parts of Monascus purpureus.

[0022] S2. Place the weighed traditional Chinese medicines in step S1 into a decocting container, and add 5 - 8 times the amount of water of the traditional Chinese medicines. After soaking the traditional Chinese medicines, first bring to a boil over high heat, then turn to low heat and simmer slowly. After boiling, decoct for 30 minutes to obtain the medicinal liquid.

[0023] S3. Filter the residue from the medicinal liquid obtained in step S2 to obtain the decoction of the traditional Chinese medicine composition.

[0024] Furthermore, the decocting container described in step S2 is a clay pot or a ceramic pot.

[0025] Furthermore, the soaking time of the traditional Chinese medicines in step S2 is 30 minutes.

[0026] A composition for treating atherosclerotic plaques provided by the above - mentioned solution of the present invention has the following functions: replenishing qi and resolving phlegm, removing stasis and dredging meridians, reducing lipid and eliminating plaques. It is mainly used for treating atherosclerotic plaques caused by the mutual binding of qi deficiency and phlegm stasis. Symptoms include: fatigue and weakness, shortness of breath and reluctance to speak, heaviness of the limbs, excessive phlegm and obesity, purple - dark tongue, ecchymosis on the edge, cyanotic sublingual collaterals, and deep and slippery pulse.

[0027] The formula explanation of a composition for treating atherosclerotic plaques provided by the above - mentioned solution of the present invention is as follows: In the formula, Astragalus membranaceus is sweet and warm, tonifying the spleen and replenishing qi, promoting qi movement and dredging meridians; Gynostemma pentaphyllum is sweet, bitter and cold, both replenishing qi and eliminating phlegm, and promoting blood circulation and reducing lipid, and they are the monarch drugs together; Roasted Perilla seed is pungent and warm, resolving phlegm and promoting qi movement, Lotus leaf is bitter and flat, removing dampness and resolving phlegm and turbidity; Sargassum is bitter, salty and cold, resolving phlegm and promoting qi movement, softening hardness and dissipating nodules; Hawthorn fruit is sour, sweet and warm, promoting qi movement and dispersing stasis, reducing turbidity and lipid, and when combined with the two monarch drugs, its power of resolving phlegm and reducing turbidity is more prominent; Pollen typhae is sweet and flat, promoting blood circulation and dredging collaterals; Alisma orientale is sweet, light and cold, removing dampness and resolving turbidity; Curcuma longa is pungent, bitter and warm, promoting blood circulation, dredging meridians and reducing lipid, Monascus purpureus is sweet and warm, replenishing qi, promoting blood circulation and removing stasis, and they are the assistant drugs together. When combined with the monarch and minister drugs, they further assist the effect of promoting blood circulation, removing stasis and dredging meridians. When all the drugs are used together, qi deficiency can be tonified, phlegm turbidity can be removed, stasis can be resolved, lumps can be dissipated, and meridians can be dredged. The formula of the composition of the present invention is a secret recipe that has been clinically applied for more than thirty years for atherosclerotic diseases. Through the inheritance, research and development of several generations of the cardiovascular department of the applicant's unit, it has been clinically used for coronary heart disease angina pectoris, myocardial infarction, atherosclerotic plaques, and lower extremity atherosclerotic obliterans, and has achieved obvious curative effects. Except for loose stools in some patients after taking the medicine, no other side effects have been found.

[0028] Syndrome and treatment mechanism: Atherosclerosis can be classified into the categories of "stasis syndrome", "phlegm syndrome" and "pulse numbness" in traditional Chinese medicine. Traditional Chinese medicine believes that its occurrence is closely related to internal deficiency, phlegm and stasis. When a person is forty, the yin qi is half gone. After entering middle age, the internal organs are damaged, the heart and spleen are insufficient, and the qi and blood have no source. The qi deficiency is unable to transport and transform the body fluid, and the body fluid becomes phlegm. In addition, eating rich and greasy food will damage the spleen and stomach, and the transportation and transformation will be disordered. Water and moisture will condense into phlegm. Over time, phlegm and turbidity will block the body, and the qi will stagnate, resulting in poor blood circulation. As the "Medical Biography" says: Body fluid is viscous, which is phlegm and drink. After a long time, it seeps into the veins and makes the blood turbid. "Qi is the commander of blood, and when Qi moves, blood moves. Qi is weak and unable to push blood vessels, which causes blood stasis and obstruction of the meridians. At the same time, blood stagnation turns into water, and water condenses into phlegm. "The Treatise on the Causes and Symptoms of Various Diseases and the Symptoms of Various Phlegms" says: "All phlegms are caused by the obstruction of blood vessels. Water accumulates and does not dissipate, thus forming phlegm." If this pathological state continues to develop, phlegm borrows from the blood, and blood borrows from phlegm to coagulate. The phlegm and blood stasis become sticky and block the blood vessels, causing damage to the blood vessels and developing into atherosclerotic plaques.

[0029] The difficulty and significance of the technical problem solved by the present invention are:

[0030] At present, most Chinese medicine compositions for treating atherosclerotic plaques are only for a certain link of atherosclerosis (such as lipid-lowering or anti-inflammatory), and it is difficult to intervene in complex pathological processes such as plaque formation, progression and instability at the same time, and the overall curative effect is not good. In the composition of the present invention, various medicines such as Radix Astragali, Gynostemma Pentaphyllum, Fructus Perillae, Lotus Leaf, Sargassum, Crataegus, Pollen Typhae, Rhizoma Alismatis, Rhizoma Curcumae, and Monascus are used together, and the effects of various medicines in the prescription are coordinated, with the effects of Qi deficiency being replenished, phlegm being removed, blood stasis being transformed, agglomeration being dispersed, and veins being unblocked. The composition of the present invention is clinically used for angina pectoris of coronary heart disease, myocardial infarction, atherosclerotic plaques, and lower extremity atherosclerotic occlusive disease, and has achieved obvious and stable curative effects. Except for individual patients having loose stools after medication, no other side effects are found, which provides important guiding significance for the treatment of atherosclerotic plaques and the development of drugs.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] 1. The composition provided by the scheme of the present invention has the effects of invigorating qi and resolving phlegm, removing blood stasis and unblocking meridians, reducing fat and eliminating plaques. It is mainly used to treat atherosclerotic plaques caused by qi deficiency, phlegm and blood stasis; symptoms include fatigue, weakness, lack of energy and laziness to speak, heavy limbs, excessive phlegm and obesity, dark purple tongue with petechiae on the sides, purple veins under the tongue, and a deep and slippery pulse; and the therapeutic effect of the composition is significant and stable, without obvious side effects;

[0033] 2. The composition of the present invention is used for the treatment of atherosclerotic plaques, can reduce the TCM syndrome score, and significantly improve the clinical symptoms of patients with carotid atherosclerosis, with an effective rate of 86.67%, which is significantly better than the effective rate of Chinese patent medicines in the prior art. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a flowchart of the preparation method of a composition for treating atherosclerotic plaques in an embodiment of the present invention. Detailed implementation manners

[0035] In order to make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0036] The implementation of the present invention will be described in detail below in conjunction with specific embodiments.

[0037] Referring to Figure 1 as shown below, the following are the preferred embodiments provided by the present invention.

[0038] Embodiment 1: A composition for treating atherosclerotic plaques provided by the solution of this Embodiment 1 is composed of the following components, by weight:

[0039] Astragalus membranaceus 5 parts, Gynostemma pentaphyllum 5 parts, roasted Perilla seed 5 parts, lotus leaf 5 parts, seaweed 5 parts, hawthorn 7.5 parts, Typha angustifolia 5 parts, Alisma orientale 5 parts, Curcuma longa 5 parts, Monascus purpureus 1.5 parts.

[0040] A preparation method of a composition for treating atherosclerotic plaques includes the following steps:

[0041] S1. Weigh the following traditional Chinese medicines according to the weight ratio for standby: Astragalus membranaceus 5 parts, Gynostemma pentaphyllum 5 parts, roasted Perilla seed 5 parts, lotus leaf 5 parts, seaweed 5 parts, hawthorn 7.5 parts, Typha angustifolia 5 parts, Alisma orientale 5 parts, Curcuma longa 5 parts, Monascus purpureus 1.5 parts;

[0042] S2. Place the traditional Chinese medicines weighed in step S1 in a decocting container such as a casserole or a ceramic pot, and add 5-8 times the amount of water of the traditional Chinese medicines. After soaking the traditional Chinese medicines for 30 minutes, first bring to a boil over high heat, then turn to low heat and simmer slowly. After boiling, decoct for 30 minutes to obtain the medicinal liquid;

[0043] S3. Filter the residue from the medicinal liquid obtained in step S2 to obtain the decoction of the traditional Chinese medicine composition.

[0044] Embodiment 2: A composition for treating atherosclerotic plaques provided by the solution of this Embodiment 2 is composed of the following components, by weight:

[0045] Astragalus membranaceus 10 parts, Gynostemma pentaphyllum 10 parts, roasted Perilla seed 10 parts, lotus leaf 10 parts, seaweed 10 parts, hawthorn 20 parts, Typha angustifolia 10 parts, Alisma orientale 10 parts, Curcuma longa 10 parts, Monascus purpureus 3 parts.

[0046] A preparation method of a composition for treating atherosclerotic plaques includes the following steps:

[0047] S1. Weigh the following traditional Chinese medicines according to the weight ratio for standby: 10 parts of Astragalus membranaceus, 10 parts of Gynostemma pentaphyllum, 10 parts of roasted Perilla seed, 10 parts of lotus leaf, 10 parts of Sargassum, 20 parts of hawthorn, 10 parts of Pollen Typhae, 10 parts of Alisma orientale, 10 parts of Curcuma longa, and 3 parts of Monascus purpureus.

[0048] S2. Place the traditional Chinese medicines weighed in step S1 in a decocting container such as a casserole or a ceramic pot, and add 5 - 8 times the amount of water of the traditional Chinese medicines. After soaking the traditional Chinese medicines for 30 minutes, first bring to a boil over high heat, then turn to low heat and simmer slowly. After boiling, decoct for 30 minutes to obtain the medicinal liquid.

[0049] S3. Filter the residue from the medicinal liquid obtained in step S2 to obtain the decoction of the traditional Chinese medicine composition.

[0050] Example 3: A composition for treating atherosclerotic plaques provided by the solution of this Example 3 is composed of the following components, in parts by weight:

[0051] 7 parts of Astragalus membranaceus, 7 parts of Gynostemma pentaphyllum, 70 parts of roasted Perilla seed, 7 parts of lotus leaf, 7 parts of Sargassum, 15 parts of hawthorn, 7 parts of Pollen Typhae, 7 parts of Alisma orientale, 7 parts of Curcuma longa, and 3 parts of Monascus purpureus.

[0052] A preparation method of a composition for treating atherosclerotic plaques includes the following steps:

[0053] S1. Weigh the following traditional Chinese medicines according to the weight ratio for standby: 7 parts of Astragalus membranaceus, 7 parts of Gynostemma pentaphyllum, 70 parts of roasted Perilla seed, 7 parts of lotus leaf, 7 parts of Sargassum, 15 parts of hawthorn, 7 parts of Pollen Typhae, 7 parts of Alisma orientale, 7 parts of Curcuma longa, and 3 parts of Monascus purpureus.

[0054] S2. Place the traditional Chinese medicines weighed in step S1 in a decocting container such as a casserole or a ceramic pot, and add 5 - 8 times the amount of water of the traditional Chinese medicines. After soaking the traditional Chinese medicines for 30 minutes, first bring to a boil over high heat, then turn to low heat and simmer slowly. After boiling, decoct for 30 minutes to obtain the medicinal liquid.

[0055] S3. Filter the residue from the medicinal liquid obtained in step S2 to obtain the decoction of the traditional Chinese medicine composition.

[0056] The compositions of Examples 1 - 3 of the present invention can also be granules, and its preparation method is as follows:

[0057] (1) Weigh 5 parts of Astragalus membranaceus, 5 parts of Gynostemma pentaphyllum, 5 parts of roasted Perilla seed, 5 parts of lotus leaf, 5 parts of Sargassum, 7.5 parts of hawthorn, 5 parts of Pollen Typhae, 5 parts of Alisma orientale, 5 parts of Curcuma longa, and 1.5 parts of Monascus purpureus according to parts by weight.

[0058] (2) Mix Astragalus membranaceus, Gynostemma pentaphyllum, roasted Perilla seed, lotus leaf, Sargassum, hawthorn, Pollen Typhae, Alisma orientale, and Monascus purpureus, add 10 times the amount of water, decoct 2 times, 1.5 hours each time, combine the decocted liquid, and filter.

[0059] (3) The turmeric is extracted with 70% ethanol and then dried to obtain turmeric extraction powder.

[0060] (4) The combined decoction after filtration is concentrated under reduced pressure to a relative density of 1.15 (measured at 60 °C).

[0061] (5) The concentrated solution is spray-dried to obtain the traditional Chinese medicine composition powder.

[0062] (6) The turmeric extraction powder and the traditional Chinese medicine composition powder are mixed with excipients and then made into granules.

[0063] The following are the experiments on the decoction of the compositions in Examples 1 - 3 of the present invention:

[0064] 1. Apply the compositions in Examples 1 - 3 of the present invention to observe the curative effect on patients with unstable angina pectoris (UAP) of coronary heart disease and the effects on tumor necrosis factor-α (TNF-α) and N-terminal pro-brain natriuretic peptide (NT-proBNP).

[0065] Method: Sixty UAP patients were randomly divided into a treatment group and a control group, with 30 cases in each group. Both groups were given conventional western medicine treatment. The treatment group additionally took the decoction of the composition in the above-mentioned examples of the present invention, and the control group additionally took Tongxinluo capsules. The course of treatment was 4 weeks.

[0066] Observe the clinical curative effects of the patients in the treatment group and the control group and the changes in the levels of TNF-α and NT-proBNP before and after treatment.

[0067] Results: There were statistically significant differences in the comprehensive curative effect, electrocardiogram curative effect, angina pectoris curative effect, traditional Chinese medicine syndrome curative effect, and the reduction and discontinuation of nitroglycerin between the treatment group and the control group (P < 0.05), and the treatment group was superior to the control group. For the levels of TNF-α and NT-proBNP, there were statistically significant differences in the comparison before and after treatment within each group (P < 0.05), and there were also statistically significant differences in the comparison between the groups after treatment (P < 0.05), and the treatment group was superior to the control group. See the following table.

[0068] (1) Comparison of the comprehensive curative effects of the two groups: The total effective rate of the treatment group was 90.0%, and that of the control group was 76.7%. After the rank sum test for the comprehensive curative effects of the two groups, the difference was statistically significant (Z = -2.232, P = 0.034). The comprehensive curative effect of the treatment group was superior to that of the control group, as shown in Table 1.

[0069] Table 1 Comparison of the comprehensive curative effects of two groups of coronary heart disease UAP patients (cases)

[0070]

[0071] (2) Comparison of electrocardiogram efficacy between the two groups: The total effective rate of the treatment group was 80.0%, and that of the control group was 63.3%. The electrocardiogram efficacy of the two groups was tested by the rank sum test, and the difference was statistically significant (Z = -2.042, P = 0.026). The electrocardiogram efficacy of the treatment group was better than that of the control group, as shown in Table 2.

[0072] Table 2 Comparison of electrocardiogram efficacy in two groups of patients with coronary heart disease UAP (cases)

[0073]

[0074] (3) Comparison of angina pectoris efficacy between the two groups: The total effective rate of the treatment group was 86.7%, and that of the control group was 66.7%. The angina pectoris efficacy of the two groups was tested by the rank sum test, and the difference was statistically significant (Z = -2.056, P = 0.03). The angina pectoris efficacy of the treatment group was better than that of the control group, as shown in Table 3.

[0075] Table 3 Comparison of angina pectoris efficacy in two groups of patients with coronary heart disease UAP (cases)

[0076]

[0077] (4) Comparison of electrocardiogram ischemic changes before and after treatment between the two groups: After treatment, the number of leads with ST segment depression, the number of leads with T wave flattening, and the number of leads with T wave inversion in the electrocardiograms of the two groups of patients all decreased. Compared with before treatment in the same group, the differences were all statistically significant (P < 0.05); after treatment, the number of leads with ST segment depression and the number of leads with T wave flattening in the treatment group were significantly lower than those in the control group, and the difference was statistically significant (P < 0.05), but the number of leads with T wave inversion in the two groups of patients was basically the same, and the difference was not statistically significant (P > 0.05). The results are shown in Table 4.

[0078] Table 4 Comparison of electrocardiogram ischemic changes before and after treatment in two groups of patients with coronary heart disease UAP

[0079]

[0080] (5) Comparison of tumor necrosis factor-α and N-terminal pro-brain natriuretic peptide levels before and after treatment between the two groups: Before treatment, there was no significant difference in the serum TNF-α and NT-proBNP levels between the two groups of patients (P > 0.05); after treatment, the serum TNF-α and NT-proBNP levels of the two groups of patients both decreased, and the differences were statistically significant compared with before treatment in the same group (P < 0.05); the differences between groups after treatment were also statistically significant (P < 0.05), indicating that the improvement degree of serum TNF-α and NT-proBNP levels in the treatment group after treatment was more significant than that in the control group. The results are shown in Table 5.

[0081] Table 5 Comparison of serum TNF-α and NT-proBNP levels before and after treatment in two groups of patients with coronary heart disease UAP ( pg / mL)

[0082]

[0083] Conclusion: Tongmai Jiangzhi Xiaoban Capsule has a significant effect in the treatment of patients with UAP and can effectively reduce the levels of TNF-α and NT-proBNP.

[0084] 2. Ninety patients with carotid atherosclerosis were observed clinically using the decoction of the composition of the above-mentioned embodiment of the present invention.

[0085] Method: Ninety patients with carotid atherosclerosis were numbered according to the order of medical treatment, and then randomly divided into two groups, namely a treatment group and a control group, by referring to a random number table. Among them, 45 patients in the treatment group were given the decoction of the composition of the present invention for treatment; 45 patients in the control group were given atorvastatin, and the treatment course for both groups was 3 months.

[0086] The clinical symptom curative effects, changes in carotid intima-media thickness (IMT), Crouse plaque score, blood lipids (TC, TG, LDL-C, HDL-C), serum high-sensitivity C-reactive protein (hs-CRP) and complement C3 levels before and after treatment and between the two groups were observed.

[0087] Among them, the decoction of the composition of the present invention can reduce the TCM syndrome score, significantly improve the clinical symptoms of patients with carotid atherosclerosis, and the effective rate (86.67%) is significantly better than that of the atorvastatin control group (56.67%), and the difference is statistically significant (p < 0.01), as shown in Table 7.

[0088] The treatment group can reduce the IMT value, reduce the Crouse plaque score, significantly lower the levels of TC, TG, and LDL-C, increase the HDL-C level, and lower the serum hs-CRP and complement C3 levels. Compared with the atorvastatin control group, the difference is not statistically significant (p > 0.05).

[0089] (1) As shown in Table 6, the comparison of the clinical symptom curative effects of the two groups of cases: In the treatment group, 11 cases were clinically controlled, 17 cases were markedly effective, 13 cases were effective, and 4 cases were ineffective, with an effective rate of 91.11%; in the control group, 5 cases were clinically controlled, 9 cases were markedly effective, 15 cases were effective, and 16 cases were ineffective, with an effective rate of 64.44%. When comparing the clinical symptom curative effects between the two groups, the effective rate of the treatment group was significantly higher than that of the atorvastatin control group, and the difference was statistically significant (P < 0.05), indicating that the treatment group was superior to the control group in improving the clinical symptom curative effect.

[0090] Table 6 Comparison of Clinical Symptom Curative Effects

[0091]

[0092] Note: When comparing the clinical symptom curative effects between the two groups, after the rank sum test, P < 0.05.

[0093] (2) As shown in Table 7, before treatment, there was no statistically significant difference in the TCM syndrome scores between the two groups after statistical processing (P > 0.05), and they were comparable. Compared with before treatment, both the treatment group and the control group could significantly reduce the TCM syndrome scores, with a statistically significant difference (P < 0.01). After treatment, when comparing between groups, the treatment group was significantly better than the control group in reducing the TCM syndrome scores, with a statistically significant difference (P < 0.01).

[0094] Table 7 Comparison of TCM syndrome scores

[0095]

[0096] Note: By unpaired t-test, when comparing between groups before treatment, ★ p > 0.05, when comparing between groups after treatment, ▲ p < 0.01; when comparing the two groups before and after treatment, by paired t-test, △ p < 0.01.

[0097] (3) As shown in Table 8, for the comparison of the curative effects of carotid atherosclerosis in the two groups of cases: in the treatment group, 4 cases had clinical control, 11 cases had marked effect, 20 cases had effective, and 9 cases had ineffective, with an effective rate of 80.00%; in the control group, 3 cases had clinical control, 12 cases had marked effect, 16 cases had effective, and 14 cases had ineffective, with an effective rate of 68.89%. When comparing the curative effects between the two groups, there was no statistically significant difference (P > 0.05), indicating that there was no difference in the curative effects between the treatment group and the control group.

[0098] Table 8 Comparison of curative effects of carotid atherosclerosis

[0099]

[0100] Note: For the comparison of the curative effects of carotid atherosclerosis in the two groups, by rank sum test, P > 0.05.

[0101] (4) As shown in Table 9, before treatment, there was no statistically significant difference in the blood lipid levels of the two groups of cases after statistical processing (P > 0.05), and they were comparable. Compared with before treatment, both the treatment group and the control group could significantly reduce TC, TG, and LDL-C and increase HDL-C, with a statistically significant difference (P < 0.01). After treatment, when comparing between groups, there was no statistically significant difference (P > 0.05), indicating that there was no difference in the effect of regulating blood lipid levels between the treatment group and the control group.

[0102] Table 9 Comparison of blood lipid changes (mmol / L, )

[0103]

[0104] Note: By paired t-test, when comparing before and after treatment,△ P < 0.01; After the paired t-test, when comparing between groups before treatment, ▲ P > 0.05, when comparing between groups after treatment, ★ P > 0.05.

[0105] (5) As shown in Table 10, before treatment, there was no statistically significant difference in IMT and Crouse scores between the two groups of cases after statistical processing (P > 0.05), and they were comparable. Compared with before treatment, both the treatment group and the control group could reduce the IMT value and decrease the Crouse score, with a statistically significant difference (P < 0.01). When comparing between groups after treatment, there was no statistically significant difference (P > 0.05). This indicates that there is no difference in the effects of reducing the IMT value and decreasing the Crouse score between the treatment group and the control group.

[0106] Table 10 Comparison of carotid IMT and Crouse plaque scores (mm, )

[0107]

[0108] Note: After the paired t-test, when comparing before and after treatment, △ P < 0.01; After the unpaired t-test, when comparing between groups before treatment, ▲ P > 0.05, when comparing between groups after treatment, ★ P > 0.05.

[0109] (6) As shown in Table 11, before treatment, there was no statistically significant difference in serum hs-CRP and complement C3 between the two groups of cases after statistical processing (P > 0.05), and they were comparable. Compared with before treatment, both the Huxinkang Tablet group and the Jingbishuxin control group could significantly reduce the levels of serum hs-CRP and complement C3, with a statistically significant difference (P < 0.01). When comparing between groups after treatment, there was no statistically significant difference (P > 0.05). This indicates that there is no difference in the effects of reducing the levels of serum hs-CRP and complement C3 between the treatment group and the control group.

[0110] Table 11 Comparison of serum hs-CRP and complement C3 levels

[0111]

[0112] Note: After the paired t-test, when comparing before and after treatment, △ P < 0.01; After the unpaired t-test, when comparing between groups before treatment, ▲ P > 0.05, when comparing between groups after treatment, ★ P > 0.05.

[0113] In summary, through the above embodiments of the present invention,

[0114] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A composition for treating atherosclerotic plaques, characterized in that, The composition consists of the following components, by weight: Astragalus membranaceus 5 - 10 parts, Gynostemma pentaphyllum 5 - 10 parts, Prepared Perilla Seed 5 - 10 parts, Lotus Leaf 5 - 10 parts, Sargassum 5 - 10 parts, Hawthorn Fruit 7.5 - 20 parts, Pollen Typhae 5 - 10 parts, Alisma orientale 5 - 10 parts, Curcuma longa 5 - 10 parts, Monascus purpureus 1.5 - 3 parts.

2. The composition for treating atherosclerotic plaque according to claim 1, characterized in that, The composition consists of the following components, by weight: Astragalus membranaceus 5 parts, Gynostemma pentaphyllum 5 parts, Prepared Perilla Seed 5 parts, Lotus Leaf 5 parts, Sargassum 5 parts, Hawthorn Fruit 10 parts, Pollen Typhae 5 parts, Alisma orientale 5 parts, Curcuma longa 5 parts, Monascus purpureus 1.5 parts.

3. The composition for treating atherosclerotic plaques according to claim 1, characterized in that, The composition consists of the following components, by weight: Astragalus membranaceus 10 parts, Gynostemma pentaphyllum 10 parts, Prepared Perilla Seed 10 parts, Lotus Leaf 10 parts, Sargassum 10 parts, Hawthorn Fruit 20 parts, Pollen Typhae 10 parts, Alisma orientale 10 parts, Curcuma longa 10 parts, Monascus purpureus 3 parts.

4. A composition for treating atherosclerotic plaques according to claim 1, characterized in that, The composition consists of the following components, by weight: Astragalus membranaceus 7 parts, Gynostemma pentaphyllum 7 parts, Prepared Perilla Seed 70 parts, Lotus Leaf 7 parts, Sargassum 7 parts, Hawthorn Fruit 15 parts, Pollen Typhae 7 parts, Alisma orientale 7 parts, Curcuma longa 7 parts, Monascus purpureus 3 parts.

5. A composition for treating atherosclerotic plaques according to any one of claims 1-4, characterized in that, The composition is a decoction or granules.

6. The preparation method of a composition for treating atherosclerotic plaques according to any one of claims 1-4, characterized in that, Including the following steps: S1. Weigh the following traditional Chinese medicinal materials according to the weight ratio for standby: Astragalus membranaceus 5 - 10 parts, Gynostemma pentaphyllum 5 - 10 parts, Prepared Perilla Seed 5 - 10 parts, Lotus Leaf 5 - 10 parts, Sargassum 5 - 10 parts, Hawthorn Fruit 7.5 - 20 parts, Pollen Typhae 5 - 10 parts, Alisma orientale 5 - 10 parts, Curcuma longa 5 - 10 parts, Monascus purpureus 1.5 - 4 parts; S2. Place the traditional Chinese medicinal materials weighed in step S1 into a decocting container, and add 5 - 8 times the amount of water of the traditional Chinese medicinal materials. After soaking the traditional Chinese medicinal materials, first bring to a boil over high heat, then turn to low heat and simmer slowly. After boiling, decoct for 30 minutes to obtain the medicinal liquid; S3. Filter the residue from the medicinal liquid obtained in step S2 to obtain the decoction of the traditional Chinese medicine composition.

7. The preparation method of a composition for treating atherosclerotic plaques according to claim 6, characterized in that, The decocting container described in step S2 is a casserole or a ceramic pot.

8. The preparation method of a composition for treating atherosclerotic plaques according to claim 6, characterized in that, The soaking time of the traditional Chinese medicinal materials in step S2 is 30 minutes.

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