A lipid-lowering and plaque-removing composition and its preparation method and application

Abstract

The invention discloses a lipid-lowering and plaque-removing composition and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine. The lipid-lowering and plaque-removing composition comprises: salvia miltiorrhiza, hawthorn, chuanxiong, notoginseng, kudzu root, chrysanthemum, astragalus, radish seed, fructus aurantii and leech. Salvia miltiorrhiza can invigorate blood circulation and dredge menstruation, and is the main medicine; hawthorn, chuanxiong and notoginseng can regulate qi and invigorate blood circulation, eliminate accumulation and relieve fullness, and are collectively the ministerial medicines; kudzu root, chrysanthemum and astragalus can invigorate the spleen and replenish qi, and are sweet and cold and nourishing, and can prevent qi and blood circulation, eliminate accumulation and eliminate phlegm, and damage the body, and can achieve one elimination and one supplement, and balance yin and yang, and are used as the assistant medicine; leech is used to strengthen the effect of invigorating blood circulation and unblocking collaterals, and is used as the guiding medicine. The main, ministerial, assistant and guiding medicines in the prescription can play the effects of eliminating phlegm and eliminating accumulation, invigorating the spleen and regulating qi, and invigorating blood circulation and unblocking collaterals. The symptoms and the root cause are treated at the same time, and the biphasic regulation is achieved to achieve the effect of treating dyslipidemia. By optimizing the preparation process, the therapeutic effect can be further improved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a lipid-lowering and plaque-removing composition and a preparation method and application thereof. Background Art

[0002] Dyslipidemia is a common metabolic disease caused by abnormal metabolism of lipoproteins in the human body. The causes of dyslipidemia are divided into primary dyslipidemia and secondary dyslipidemia. The former is caused by genetic defects, and the latter is caused by diseases, drugs, unhealthy diet and lifestyle. Clinical manifestations include symptoms of coronary heart disease and peripheral vascular disease such as xanthomas and arteriosclerosis. Dyslipidemia can cause a variety of diseases, such as cardiovascular disease, diabetes, cancer, etc., which seriously threaten the quality of life and life safety. Therefore, research on drugs to treat dyslipidemia is more urgent.

[0003] Statins and fibrates are the main drugs used clinically for treatment, which require lifelong medication, have high treatment costs, and long-term use of drugs has side effects of varying degrees.

[0004] Traditional Chinese medicine has the advantages of regulating dyslipidemia through multiple pathways, multiple targets, and multiple levels, and has few adverse reactions. Modern medical research shows that traditional Chinese medicine can regulate the peroxisome proliferator-activated receptor signaling pathway, adenylate-activated protein kinase signaling pathway, cyclic adenosine monophosphate signaling pathway, adipose cell factor signaling pathway, farnesoid derivative X receptor / small heterodimer partner signaling pathway, phosphatidylinositol 3-kinase / protein kinase signaling pathway, etc., affecting the synthesis, decomposition and absorption of lipids, improving liver lipid and bile acid metabolism, etc., thereby playing a lipid-lowering role. Traditional Chinese medicine has the advantages of definite efficacy, relatively low toxicity, and low cost in the treatment of hyperlipidemia, so it has attracted more and more attention.

[0005] The journal article ("Observation on the Effect of Traditional Chinese Medicine Panax Notoginseng Powder in the Treatment of Hyperlipidemia", Wang Heng, "Chinese Health Care and Nutrition", Issue 19, 2020) studied the effect of traditional Chinese medicine Panax Notoginseng powder on the treatment of hyperlipidemia. The results showed that the total effective rate of the observation group was 96.43%, and that of the control group was 78.57%. The incidence of adverse reactions in the observation group was 1.79%, and that in the control group was 21.43%, P>0.05, which was statistically significant; the improvement in the levels of triglycerides (TG), serum total cholesterol (TC), and high / low-density lipoprotein (HDL-C / LDL-C) in the observation group was better than that in the control group, P<0.05, which was statistically significant. It can be seen that the treatment of hyperlipidemia with traditional Chinese medicine Panax Notoginseng powder can effectively improve the overall treatment efficiency, reduce the impact of adverse reactions on patients, and improve the relevant blood lipid levels of patients.

[0006] The journal article ("Observation on the Efficacy of Red Yeast in Treating Hyperlipidemia in Different TCM Constitution Types", Zhang Shujun et al., "Journal of Practical Chinese Medicine Internal Medicine", Issue 8, 2020) analyzed the differences in the efficacy of red yeast rice in treating hyperlipidemia in different TCM constitution types. The results showed that after 8 weeks of treatment, the total effective rate of red yeast rice in treating hyperlipidemia in different TCM constitution types was: phlegm-damp constitution > blood stasis constitution > peaceful constitution > yin deficiency constitution; the differences between the syndromes were not statistically significant (P>0.05); compared with before treatment, the serum total cholesterol of phlegm-damp constitution, blood stasis constitution, and peaceful constitution decreased significantly after treatment (P<0.05); the decrease in serum total cholesterol of phlegm-damp constitution and blood stasis constitution after treatment was lower than that of yin deficiency constitution There were significant differences in deficiency constitution and peaceful constitution (P<0.05), but there was no significant difference between phlegm-dampness constitution and blood stasis constitution (P>0.05), and there was no significant difference between peaceful constitution and Yin deficiency constitution (P>0.05). Compared with before treatment, serum triglycerides of phlegm-dampness constitution and blood stasis constitution decreased significantly after treatment (P<0.05), and there was no significant difference between each type (P>0.05); compared with before treatment, serum low-density lipoprotein cholesterol of phlegm-dampness constitution and blood stasis constitution decreased significantly after treatment (P<0.05), and the decrease in serum low-density lipoprotein cholesterol of phlegm-dampness constitution was better than that of peaceful constitution and Yin deficiency constitution (P<0.05). No adverse reactions such as increased transaminase occurred in patients with each constitution during treatment. It can be seen that the traditional Chinese medicine red yeast rice is effective in treating hyperlipidemia. Phlegm-dampness constitution is the most advantageous constitution type for treatment with red yeast rice, followed by blood stasis constitution and balanced constitution, while the effect of red yeast rice in treating hyperlipidemia in yin deficiency constitution is poor.

[0007] Patent (CN117379483A) discloses a Chinese medicine composition for treating hyperlipidemia, which is an extract of a mixture of three raw materials: ginseng, hawthorn, and sophora japonica. In the raw material components, the ratio of ginseng to hawthorn is 2:1-1:2, and the ratio of hawthorn to sophora japonica is 2:1-2:2. The prepared Chinese medicine composition has simple components and an ideal lipid-lowering effect.

[0008] It can be seen that it is feasible to use traditional Chinese medicine to treat dyslipidemia. However, the ingredients of traditional Chinese medicine for lowering blood lipids on the market are relatively simple, the efficacy is not satisfactory, and it usually only has a therapeutic effect on specific diseases.

[0009] Based on this, it is necessary to provide a lipid-lowering and plaque-removing composition that can regulate dyslipidemia in multiple ways, multiple targets, and multiple levels, and has a broad-spectrum therapeutic effect on dyslipidemia diseases. Summary of the invention

[0010] The present invention aims at the problems existing in the prior art, and provides a lipid-lowering and plaque-removing composition and its preparation method and application. The lipid-lowering and plaque-removing composition comprises: salvia miltiorrhiza, hawthorn, chuanxiong, notoginseng, kudzu root, chrysanthemum, astragalus, radish seed, fructus aurantii and leech. Salvia miltiorrhiza can promote blood circulation and dredge menstruation, and is the main medicine; raw hawthorn, chuanxiong and notoginseng can regulate qi and promote blood circulation, eliminate accumulation and relieve fullness, and are the ministerial medicines; kudzu root, chrysanthemum and raw astragalus can invigorate the spleen and replenish qi, and are sweet and cold to nourish, and can prevent qi and blood circulation, eliminate accumulation and eliminate phlegm, and damage the body, and achieve one elimination and one supplement, and balance yin and yang, and are the assistant medicine; leech is used to strengthen the effect of promoting blood circulation and unblocking collaterals, and is the guiding medicine. The main, minister, assistant and guiding medicines in the prescription play the effects of eliminating phlegm and eliminating accumulation, strengthening the spleen and regulating qi, and promoting blood circulation and unblocking collaterals. The symptoms and the root cause are treated at the same time, and the biphasic regulation is achieved to achieve the effect of treating dyslipidemia. By optimizing the preparation process, the therapeutic effect can be further improved.

[0011] To achieve the above objectives, in a first aspect, the present invention provides a lipid-lowering and spot-removing composition, comprising salvia miltiorrhiza, hawthorn, chuanxiong, notoginseng, kudzu root, chrysanthemum, astragalus, radish seed, fructus aurantii and leech.

[0012] TCM believes that hyperlipidemia and other dyslipidemia-related diseases are chronic diseases characterized by qi, blood, phlegm, stasis, and accumulation, and are characterized by a mixture of deficiency and excess. Professor Guo Weiqin of Dongzhimen Hospital of Beijing University of Chinese Medicine also believes that the nature of this disease is deficiency in the root and excess in the superficial. The root deficiency is in the spleen, and the superficial excess is in phlegm and blood stasis. It is very similar to Tang Rongchuan's "Blood Symptoms" "It should be known that phlegm congestion is caused by blood stasis" and "blood accumulation for a long time can also turn into phlegm water". Zhou Xiajing and others from the Institute of Basic Theory of China Academy of Chinese Medical Sciences confirmed through animal experiments that peroxy lipids are an important factor in vascular endothelial damage and are the central link in the TCM phlegm and stasis theory; endothelial damage is the main pathological feature of phlegm-induced stasis, and lipid metabolism disorders and internal and external factors that cause lipid metabolism disorders are the causes of phlegm and stasis.

[0013] The lipid-lowering and spot-removing composition of the present invention is a compound preparation composed of ten medicines, including salvia miltiorrhiza, raw hawthorn, chuanxiong, notoginseng, kudzu root, chrysanthemum, raw astragalus, stir-fried radish seeds, stir-fried fructus aurantii and leech. Salvia miltiorrhiza is the main medicine for promoting blood circulation and dredging menstruation; raw hawthorn, chuanxiong and notoginseng are the ministerial medicines for regulating qi and promoting blood circulation, eliminating accumulation and relieving fullness; kudzu root, chrysanthemum and raw astragalus are the ministerial medicines for strengthening spleen and replenishing qi, and are sweet and cold for nourishing, which can prevent qi and blood circulation, eliminate accumulation and eliminate phlegm and damage the body, and achieve one elimination and one supplement, and balance yin and yang, and are the assistant medicines; leech is used to strengthen the effect of promoting blood circulation and unblocking collaterals. The main, ministerial, assistant and envoy medicines in the prescription play the effects of eliminating phlegm and eliminating accumulation, strengthening spleen and regulating qi, promoting blood circulation and unblocking collaterals. The symptoms and the root cause are treated at the same time, and the purpose of treating dyslipidemia is achieved through biphasic regulation.

[0014] The lipid-lowering and plaque-removing composition has the effects of resolving phlegm and eliminating accumulation, strengthening the spleen and regulating qi, and promoting blood circulation and unblocking collaterals, and is used for hyperlipidemia caused by phlegm and turbidity. Symptoms include carotid artery plaques, obesity, dizziness, heavy head, chest tightness and shortness of breath, limb numbness, fatigue, abdominal distension, poor appetite and sticky mouth, nausea and vomiting, greasy tongue coating, stringy pulse, etc. By reducing lipids and eliminating accumulation, promoting blood circulation and removing blood stasis, and regulating the functions of the central nervous system, endocrine system and immune system, it can reduce blood lipids, soften blood vessels, and eliminate arterial vascular sclerosis plaques; improve the hypercoagulable state of blood, dilate blood vessels, and reduce peripheral resistance; adjust blood pressure, improve blood circulation, and reduce myocardial oxygen consumption. After long-term clinical use, it can effectively prevent and treat hyperlipidemia, polycystic ovary syndrome, hypertension, hyperviscosity, coronary heart disease, cerebral thrombosis and other dyslipidemia-related diseases.

[0015] In a preferred embodiment, the lipid-lowering and spot-removing composition comprises, by weight: 10-20 parts of Salvia miltiorrhiza, 10-20 parts of Crataegus, 8-14 parts of Ligusticum chuanxiong, 5-15 parts of Panax notoginseng, 10-20 parts of Pueraria lobata, 10-20 parts of Chrysanthemum, 15-25 parts of Astragalus, 10-20 parts of Radish Seed, 8-14 parts of Citrus aurantium and 4-8 parts of Leech.

[0016] In a preferred embodiment, the lipid-lowering and spot-removing composition comprises, by weight: 15 parts of salvia miltiorrhiza, 15 parts of hawthorn, 12 parts of chuanxiong, 10 parts of panax notoginseng, 15 parts of kudzu root, 15 parts of chrysanthemum, 20 parts of astragalus, 15 parts of radish seeds, 12 parts of aurantium and 6 parts of leech.

[0017] In a preferred embodiment, the hawthorn is raw hawthorn, the astragalus is raw astragalus, the radish seeds are fried radish seeds, and the fructus aurantii is fried fructus aurantii.

[0018] In a second aspect, the present invention provides a method for preparing the lipid-lowering and plaque-removing composition, comprising the following steps:

[0019] 1) Grind astragalus, hawthorn and Panax notoginseng into powder to obtain powder;

[0020] 2) extracting radish seeds and leeches with water to obtain a water extract;

[0021] 3) extracting the remaining medicinal materials with ethanol to obtain an ethanol extract;

[0022] 4) combining the water extract and the alcohol extract, evaporating the ethanol, concentrating and making pills with the powder to obtain the lipid-lowering and plaque-removing composition.

[0023] In a preferred embodiment, in step 1), the powder is crushed to 100-400 meshes.

[0024] In a preferred embodiment, in step 2), the volume mass ratio of water to medicinal material is 8-25 mL / g, and the extraction condition is decoction extraction for 2-6 h.

[0025] In a preferred embodiment, in step 3), the mass volume ratio of the remaining medicinal material to ethanol is 1 g: 5-15 mL, the extraction temperature is 20-60° C., and the extraction time is 3-10 h; the volume concentration of ethanol is 70-90%.

[0026] In a preferred embodiment, in step 4), the mixture is concentrated to a relative density of 1.20-1.30 (@25° C.).

[0027] In a third aspect, the present invention provides use of the lipid-lowering and plaque-removing composition in the preparation of a drug for treating and / or preventing diseases related to dyslipidemia.

[0028] In a preferred embodiment, the dyslipidemia-related diseases include hyperlipidemia, polycystic ovary syndrome, hypertension, hyperviscosity, carotid artery plaque, coronary heart disease and cerebral thrombosis.

[0029] The beneficial effects of the present invention are:

[0030] 1. The lipid-lowering and plaque-removing composition of the present invention has the effects of resolving phlegm and eliminating accumulation, strengthening the spleen and regulating qi, and promoting blood circulation and unblocking collaterals. It treats both the symptoms and the root cause, and achieves the purpose of treating dyslipidemia through biphasic regulation.

[0031] 2. The lipid-lowering and plaque-removing composition of the present invention can effectively prevent and treat dyslipidemia-related diseases such as hyperlipidemia, polycystic ovary syndrome, hypertension, hyperviscosity syndrome, coronary heart disease, cerebral thrombosis, carotid artery plaque, etc.

[0032] 3. The lipid-lowering and plaque-removing composition of the present invention is in the form of pills, which can solve the problems of troublesome decoction, poor taste, and poor medication compliance of decoctions. Compared with other dosage forms, no auxiliary materials need to be added, the actual drug loading amount is high, and the efficacy is slow, but the effect is long-lasting. It is suitable for the treatment of chronic diseases such as dyslipidemia and is consistent with the main indications. DETAILED DESCRIPTION

[0033] The present invention will be further described below in conjunction with specific embodiments, and the advantages and features of the present invention will become clearer as the description proceeds. However, these embodiments are exemplary only and do not constitute any limitation to the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.

[0034] It is worth noting that the raw materials used in the present invention are all common commercially available products, and their sources are not specifically limited.

[0035] Example 1

[0036] Preparation of lipid-lowering and plaque-removing composition:

[0037] The composition is as follows according to weight: 15 parts of salvia miltiorrhiza, 15 parts of hawthorn, 12 parts of chuanxiong, 10 parts of panax notoginseng, 15 parts of kudzu root, 15 parts of chrysanthemum, 20 parts of astragalus, 15 parts of radish seeds, 12 parts of aurantium and 6 parts of leech;

[0038] The preparation process is as follows:

[0039] 1) Grind astragalus, hawthorn and Panax notoginseng into powder, and grind into 200 mesh to obtain powder;

[0040] 2) Take radish seeds and leeches, add water according to the volume mass ratio of water to medicinal materials of 12 mL / g, and boil for 4 hours to obtain a water extract;

[0041] 3) Extract the remaining medicinal materials with 80% ethanol at 40° C. for 6 h, with the mass volume ratio of the remaining medicinal materials to ethanol being 1 g:10 mL, and filter to obtain the alcohol extract;

[0042] 4) The water extract and the alcohol extract are combined, the ethanol is evaporated, the extract is concentrated to a relative density of 1.25 at 25° C., and then pelleted with the powder to obtain the lipid-lowering and plaque-removing composition.

[0043] Example 2

[0044] Preparation of lipid-lowering and plaque-removing composition:

[0045] The composition is as follows according to weight: 10 parts of salvia miltiorrhiza, 20 parts of hawthorn, 8 parts of chuanxiong, 15 parts of panax notoginseng, 10 parts of kudzu root, 20 parts of chrysanthemum, 25 parts of astragalus, 10 parts of radish seeds, 14 parts of aurantium and 4 parts of leech;

[0046] The preparation process is as follows:

[0047] 1) Grind astragalus, hawthorn and Panax notoginseng into powder, and grind into 300 mesh to obtain powder;

[0048] 2) Take radish seeds and leeches, add water according to the volume mass ratio of water to medicinal materials of 20 mL / g, and boil for 3 hours to obtain a water extract;

[0049] 3) Extract the remaining medicinal materials with 90% ethanol at 25° C. for 8 h, with the mass volume ratio of the remaining medicinal materials to ethanol being 1 g:5 mL, and filter to obtain the alcohol extract;

[0050] 4) The water extract and the alcohol extract are combined, the ethanol is evaporated, the extract is concentrated to a relative density of 1.25 at 25° C., and then pelleted with the powder to obtain the lipid-lowering and plaque-removing composition.

[0051] Example 3

[0052] Preparation of lipid-lowering and plaque-removing composition:

[0053] The composition is as follows according to weight: 20 parts of salvia miltiorrhiza, 10 parts of hawthorn, 14 parts of chuanxiong, 5 parts of panax notoginseng, 20 parts of kudzu root, 10 parts of chrysanthemum, 15 parts of astragalus, 20 parts of radish seeds, 8 parts of aurantium and 8 parts of leech;

[0054] The preparation process is as follows:

[0055] 1) Grind astragalus, hawthorn and Panax notoginseng into powder, and grind into 100 mesh to obtain powder;

[0056] 2) Take radish seeds and leeches, add water according to the volume mass ratio of water to medicinal materials 8mL / g, and boil for 5h to obtain a water extract;

[0057] 3) Extract the remaining medicinal materials with 70% ethanol at 60° C. for 4 h, with the mass volume ratio of the remaining medicinal materials to ethanol being 1 g:15 mL, and filter to obtain the alcohol extract;

[0058] 4) The water extract and the alcohol extract are combined, the ethanol is evaporated, the extract is concentrated to a relative density of 1.25 at 25° C., and then pelleted with the powder to obtain the lipid-lowering and plaque-removing composition.

[0059] Comparative Example 1

[0060] Except that borneol is used to replace Panax notoginseng, the rest is the same as Example 1.

[0061] Comparative Example 2

[0062] Except that Codonopsis pilosula was used instead of Salvia miltiorrhiza, the rest was the same as in Example 1.

[0063] Comparative Example 3

[0064] Except that Panax notoginseng is used to replace radish seeds and leeches (i.e., 31 parts of Panax notoginseng are used, 10 parts of which are added in step 1) and 21 parts are added in step 2)), the rest is the same as Example 1.

[0065] Comparative Example 4

[0066] Except for adding Panax notoginseng in step 2), the rest is the same as Example 1.

[0067] Comparative Example 5

[0068] Except for adding Panax notoginseng in step 3), the rest is the same as Example 1.

[0069] Comparative Example 6

[0070] Except that the raw materials other than astragalus, hawthorn and Panax notoginseng are added in step 2), the rest are the same as in Example 1, that is, the preparation process is as follows:

[0071] 1) Grind astragalus, hawthorn and Panax notoginseng into powder, and grind into 200 mesh to obtain powder;

[0072] 2) Take the remaining medicinal materials, add water according to the volume mass ratio of water to medicinal materials of 12mL / g, and boil for 4h to obtain a water extract;

[0073] 3) The water extract is concentrated to a relative density of 1.25 at 25°C and then pelletized with the powder to obtain the product.

[0074] Comparative Example 7

[0075] Except that the raw materials other than astragalus, hawthorn and Panax notoginseng are added in step 3), the rest are the same as in Example 1, that is, the preparation process is as follows:

[0076] 1) Grind astragalus, hawthorn and Panax notoginseng into powder, and grind into 200 mesh to obtain powder;

[0077] 2) extract the remaining medicinal materials with 80% ethanol at 40° C. for 6 h, wherein the mass volume ratio of the remaining medicinal materials to ethanol is 1 g:10 mL, and filter to obtain an alcohol extract;

[0078] 3) Take the alcohol extract, evaporate the ethanol, concentrate it to a relative density of 1.25 at 25°C, and then make pills with the powder to obtain the product.

[0079] Application Example 1

[0080] The lipid-lowering and plaque-removing composition has the effect of lowering blood lipids

[0081] 1. Experimental animals: SPF male SD rats 120, purchased from the Animal Experiment Center of Zhongnan Hospital of Wuhan University, weighing 180±20 g.

[0082] 2. Modeling and intervention: The purchased rats were adaptively fed for 7 days before modeling. The rats in the control group (10 rats) had a normal diet, and the other rats were fed with a basic feed and given a high-fat emulsion (20wt% lard, 5wt% cholesterol, 5wt% egg yolk powder, 1wt% propylthiouracil, 6wt% Tween-80, 63wt% distilled water) by gavage once a day, with each dose of 10mL / kg, for 4 consecutive weeks.

[0083] The rats after modeling were randomly divided into 11 groups, with 10 rats in each group. From the 5th week, the control group and the model group were gavaged with normal saline (10 mL / kg), and the Example 1-3 and Comparative Example 1-7 groups were administered with the corresponding lipid-lowering plaque-removing composition (dose of raw drug amount 12 g / kg), once a day, for 4 consecutive weeks.

[0084] 4. Detection: After the administration, all rats were fasted but not watered for 12 h. Blood was collected from the abdominal aorta after chloral hydrate anesthesia. Serum was collected by centrifugation and total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL) and high-density lipoprotein (HDL) were measured using an automatic biochemical analyzer (Mindray BS-350S). The results are shown in Table 1.

[0085] Table 1 Biochemical indexes of rats in each group

[0086] Group TC(mmol / L) TG (mmol / L) LDL (mmol / L) HDL (mmol / L) Control group <![CDATA[1.55±0.24 ## ]]> <![CDATA[1.42±0.56 ## ]]> <![CDATA[0.31±0.05 ## ]]> <![CDATA[0.72±0.07 # ]]> Model Group 4.52±0.80** 3.48±0.82** 1.34±0.27** 1.57±0.15* Example 1 <![CDATA[2.36±0.51* ## ]]> <![CDATA[1.35±0.42 ## ]]> <![CDATA[0.56±0.13 # ]]> <![CDATA[0.89±0.08 # ]]> Example 2 <![CDATA[2.54±0.55* ## ]]> <![CDATA[1.59±0.51 ## ]]> <![CDATA[0.62±0.14 # ]]> <![CDATA[0.92±0.09 # ]]> Example 3 <![CDATA[2.42±0.53* ## ]]> <![CDATA[1.44±0.56 ## ]]> <![CDATA[0.59±0.15 # ]]> <![CDATA[0.86±0.09 # ]]> Comparative Example 1 3.89±0.72** 2.89±0.76* 1.05±0.21* 1.32±0.14* Comparative Example 2 <![CDATA[3.56±0.68** # ]]> 2.77±0.74* 0.98±0.18* 1.27±0.13* Comparative Example 3 4.12±0.76** 3.01±0.83* 1.12±0.23* 1.41±0.15* Comparative Example 4 <![CDATA[3.41±0.65** # ]]> <![CDATA[2.48±0.68* # ]]> 0.92±0.18* 1.18±0.11* Comparative Example 5 <![CDATA[3.61±0.70** # ]]> <![CDATA[2.39±0.64* # ]]> 0.95±0.16* 1.23±0.12* Comparative Example 6 <![CDATA[3.77±0.72** # ]]> 2.98±0.70* 1.01±0.24* 1.19±0.13* Comparative Example 7 4.04±0.77** 2.80±0.68* 0.99±0.19* 1.27±0.12*

[0087] Note: * indicates P < 0.05 compared with the control group; ** indicates P < 0.01 compared with the control group; # indicates P < 0.05 compared with the model group; ## Compared with the model group, P < 0.05.

[0088] As can be seen from Table 1, the total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein contents of the model group rats were significantly higher than those of the control group, indicating that the modeling was successful. The total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein contents of the Example 1-3 groups were closer to the control group and had significant differences from the model group, indicating that the lipid-lowering plaque-removing composition of the present invention has a significant lipid-lowering effect.

[0089] Comparison of Example 1 and Comparative Examples 1-3 shows that the raw material composition of the lipid-lowering and plaque-removing composition has a significant effect on its lipid-lowering effect. In the system of the present invention, using Panax notoginseng compared to borneol, or using Salvia miltiorrhiza compared to Codonopsis pilosula, or using Panax notoginseng in combination with Radish Seed and Leech is beneficial to improving the therapeutic effect.

[0090] Comparison of Example 1 and Comparative Examples 4-7 shows that the preparation process also has a significant impact on the lipid-lowering effect of the lipid-lowering and plaque-removing composition. The preparation process defined in the present invention is conducive to preparing a lipid-lowering and plaque-removing composition with better lipid-lowering effect.

[0091] Application Example 2 Clinical Observation of Hyperlipidemia

[0092] 1. A total of 60 patients with hyperlipidemia admitted from August 2023 to May 2024 were selected, including 38 males and 22 females; aged 23-73 years, with an average age of (43±11.38) years; the course of hyperlipidemia ranged from 4 months to 18 years, with an average of (5.03±1.92) years; hyperlipidemia types: 17 cases of hypercholesterolemia, 26 cases of hypertriglyceridemia, and 17 cases of mixed type.

[0093] 2. Treatment method: Take 7 g of the lipid-lowering and plaque-removing composition of Example 1 three times a day for 20 consecutive days.

[0094] 3. Observation index and efficacy judgment standard: Referring to the standards in the "Guidelines for Clinical Research of New Chinese Medicines", the efficacy is divided into the following four levels: clinical control: all blood lipid indicators are normal; marked effect: serum triglycerides are reduced by no less than 40%, serum total cholesterol is reduced by no less than 20%, serum high-density lipoprotein cholesterol is increased by no less than 0.26mmol / L, and arteriosclerosis index is reduced by no less than 20%, and any one of them is met; effective: serum triglycerides are reduced by 20%-40%, serum total cholesterol is reduced by 10%-20%, serum high-density lipoprotein cholesterol is increased by 0.104-0.26mmol / L, and arteriosclerosis index is reduced by 10%-20%, and any one of them is met; ineffective: the improvement of blood lipid indicators is not as good as that of effective patients. Among them, arteriosclerosis index = (serum total cholesterol-serum high-density lipoprotein) / serum high-density lipoprotein. Total effective = clinical control + marked effect + effective, the results are shown in Table 2.

[0095] Table 2 Treatment effect of hyperlipidemia

[0096] Group Total number of cases Number of clinical control cases Number of effective cases Number of effective cases Invalid cases Total Effectiveness Example 1 60 36 6 13 5 91.7％

[0097] Application Example 3 Other Clinical Treatment Experience

[0098] 1. Polycystic ovary syndrome

[0099] Case 1: Female, 39 years old, polycystic ovary syndrome, the number of follicles was 12 on December 9, 2023, and after taking the lipid-lowering and plaque-removing composition of Example 1 for 1 month (3 times a day, 7 g each time, the same medication method for other cases), the number of follicles was <5 on January 18, 2024, which was significantly improved.

[0100] Case 2: Female, 28 years old, polycystic ovary syndrome, the number of follicles was >10 on November 24, 2023 by B-ultrasound examination. After taking the lipid-lowering and plaque-removing composition of Example 1 for 14 days, the number of follicles was <5 on B-ultrasound examination on December 14, 2023, which was significantly improved.

[0101] Case 3: Female, 26 years old, polycystic ovary syndrome, B-ultrasound examination on December 25, 2023 showed that the number of follicles was greater than 12. After taking the lipid-lowering and plaque-removing composition of Example 1 for 23 days, the patient was found to be pregnant on January 19, 2024, with significant results.

[0102] Case 4: Female, 33 years old, secondary infertility for more than one year, B-ultrasound examination on December 19, 2023 showed that the number of follicles was >10, and sex hormone examination showed LH / FSH>2, accompanied by acne and menstrual disorders. After taking the lipid-lowering and spot-removing composition of Example 1 for 15 days after the menstrual period in December, she became pregnant successfully.

[0103] Case 5: Female, 26 years old, polycystic ovary syndrome, B-ultrasound examination on April 22, 2024 showed cervical retention cysts, and the number of follicles was >10. After taking the lipid-lowering and plaque-removing composition of Example 1 for 14 days, B-ultrasound on May 6, 2024 showed that the cysts disappeared, the follicles decreased, and the weight decreased by about 4 pounds.

[0104] Case 6: Female, 28 years old, with hyperlipidemia and polycystic ovary syndrome, the test report on May 1, 2024 indicated total cholesterol of 5.63 and triglycerides of 6.74. She took the lipid-lowering and plaque-removing composition of Example 1 for 14 days. The total cholesterol dropped to 4.34 and triglycerides to 2.44 on May 28, 2024, and she was pregnant, with significant results.

[0105] 2. Carotid artery plaque:

[0106] Case 1: Male, 53 years old, carotid artery plaque, ultrasound on September 27, 2023 showed the formation of atherosclerotic plaques in the right subclavian artery and bilateral common carotid arteries. On December 15, 2023, he began to take the lipid-lowering and plaque-removing composition of Example 1 for 27 days. On January 12, 2024, ultrasound showed the formation of plaques on the posterior wall of the starting segment of the right subclavian artery, and there was no obvious abnormality in the inner diameter and blood flow of the bilateral common carotid arteries and bilateral driving vessels (i.e., the plaques had disappeared).

[0107] Case 2: Male, 74 years old, carotid artery plaques, rough intimal plaques were found to have formed in both lower limb arteries for one year. On March 8, 2024, the intimal thickening of the anterior wall of the left popliteal artery was detected, and there were 12.4mm mixed plaques. After taking the lipid-lowering plaque-removing composition of Example 1 for more than 40 days, the follow-up B-ultrasound showed that the mixed plaques of the left popliteal artery disappeared.

[0108] Case 3: Male, 53 years old, hyperlipidemia, carotid artery plaques, ultrasound on March 19, 2024 showed the formation of atherosclerotic plaques in the right subclavian artery (mixed plaques) and bilateral common carotid arteries (mixed plaques), total cholesterol 5.75, took the lipid-lowering plaque-removing composition of Example 1 for 30 days, ultrasound on May 31, 2024 showed the formation of atherosclerotic plaques in the right common carotid artery and right subclavian artery, and there was no obvious abnormality in the inner diameter and blood flow of the bilateral driving arteries (i.e., the plaques had disappeared).

[0109] The scheme of the present invention is not limited to the technical means disclosed by the above technical means, but also includes a technical scheme composed of any combination of the above technical features. The above is a specific implementation method of the present invention. It should be pointed out that for ordinary technicians in the field of ursodeoxycholic acid in this technology, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications are also considered as the protection scope of the present invention.

Claims

1. A lipid-lowering and plaque-removing composition, characterized in that: The lipid-lowering and plaque-removing composition is composed of the following components by weight: 10-20 parts of salvia miltiorrhiza, 10-20 parts of hawthorn, 8-14 parts of chuanxiong, 5-15 parts of panax notoginseng, 10-20 parts of kudzu root, 10-20 parts of chrysanthemum, 15-25 parts of astragalus, 10-20 parts of radish seeds, 8-14 parts of aurantium and 4-8 parts of leech.

2. The lipid-lowering plaque-removing composition according to claim 1, characterized in that: The lipid-lowering and plaque-removing composition is composed of the following components by weight: 15 parts of salvia miltiorrhiza, 15 parts of hawthorn, 12 parts of chuanxiong, 10 parts of panax notoginseng, 15 parts of kudzu root, 15 parts of chrysanthemum, 20 parts of astragalus, 15 parts of radish seeds, 12 parts of aurantium and 6 parts of leech.

3. The lipid-lowering plaque-removing composition according to claim 1, characterized in that: The hawthorn is raw hawthorn, the astragalus is raw astragalus, the radish seed is fried radish seed, and the fructus aurantii is fried fructus aurantii.

4. The method for preparing the lipid-lowering and plaque-removing composition according to any one of claims 1 to 3, characterized in that: The steps include: 1) Grind astragalus, hawthorn and Panax notoginseng into powder to obtain powder; 2) Take radish seeds and leeches and extract them with water to obtain a water extract; 3) Extract the remaining medicinal materials with ethanol to obtain an alcohol extract; 4) combining the water extract and the alcohol extract, evaporating the ethanol, concentrating and making pills with the powder to obtain the lipid-lowering and plaque-removing composition.

5. The method for preparing the lipid-lowering plaque-removing composition according to claim 4, characterized in that: In step 1), the powder is crushed to 100-400 mesh.

6. The method for preparing the lipid-lowering plaque-removing composition according to claim 4, characterized in that: In step 2), the volume mass ratio of water to medicinal materials is 8-25 mL / g, and the extraction conditions are decoction extraction for 2-6 hours; in step 3), the mass volume ratio of the remaining medicinal materials to ethanol is 1 g:5-15 mL, the extraction temperature is 20-60° C., and the extraction is performed for 3-10 hours; the volume concentration of ethanol is 70-90%.

7. The method for preparing the lipid-lowering plaque-removing composition according to claim 4, characterized in that: In step 4), the mixture is concentrated to a relative density of 1.20-1.30 at 25°C.

8. Use of the lipid-lowering and plaque-removing composition according to any one of claims 1 to 3 in the preparation of a medicament for treating and / or preventing dyslipidemia-related diseases, wherein the dyslipidemia-related diseases are hyperlipidemia, polycystic ovary syndrome, and carotid artery plaque.