Traditional Chinese medicine composition, traditional Chinese medicine preparation, preparation method and application

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method and application. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 4.5 to 18 parts of radix astragali seu hedysari, 3 to 12 parts of wine-processed fructus ligustri lucidi, 4.5 to 18 parts of radix acanthopanacis semticosi, 3.5 to 14 parts of radix salviae miltiorrhizae, 4 to 16 parts of radix paeoniae rubra, 3.5 to 14 parts of rhizoma chuanxiong, 4.5 to 18 parts of fructus crataegi, 3 to 12 parts of flos carthami, 2.5 to 10 parts of radix notoginseng, 5 to 20 parts of caulis spatholobi and 4 to 16 parts of radix puerariae. The traditional Chinese medicine composition has the effects of reducing blood fat, resisting inflammation, inhibiting and reducing atherosclerotic plaque and the like, and is used for treating diabetes atherosclerosis.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, and a preparation method and use thereof. BACKGROUND

[0002] Atherosclerosis has a complex pathogenesis, and its main factors are lipid accumulation and chronic inflammation in the arterial wall. Atherosclerosis is usually associated with changes in lipid metabolism and hypercholesterolemia. Elevated levels of modified low-density lipoprotein (LDL) in circulation are a known risk factor for cardiovascular disease. A series of pathological events leading to the development of atherosclerosis is believed to be caused by local endothelial dysfunction, which can be caused by blood flow turbulence near the bending or bifurcation sites of the artery. The response of the vascular endothelium to mechanical stress is activation, which subsequently leads to the recruitment of circulating immune cells. Circulating monocytes adhere to the damaged area of the arterial wall and penetrate the interior, differentiating into macrophages, actively participating in lipid uptake through phagocytosis, and producing a large number of foam cells present in atherosclerotic plaques. The pathogenesis of atherosclerosis is more complex than changes in lipid metabolism, involving multiple factors, of which the most prominent is inflammation.

[0003] Diabetes mellitus is a group of disorders of carbohydrate metabolism, the main feature of which is chronic hyperglycemia caused by defects in insulin secretion, insulin action, or a combination thereof. Metabolic abnormalities observed in diabetes mellitus can be caused by low levels of insulin production and / or insulin resistance in target tissues. The pathogenesis of diabetes mellitus and atherosclerosis is closely related, but the mechanisms and molecular interactions of this relationship are still under discussion. Known pathogenic mechanisms of diabetes mellitus and atherosclerosis include dyslipidemia, hyperglycemia with late-stage glycosylation end product (AGE) generation, increased oxidative stress, and inflammation. Although new treatments are still being sought, few drugs have shown strong beneficial effects in reducing the risk of atherosclerosis development in specific populations of diabetic patients. SUMMARY

[0004] The purpose of the present application is to provide a traditional Chinese medicine composition, and a traditional Chinese medicine preparation prepared from the traditional Chinese medicine composition, which has the effects of lowering blood lipids, anti-inflammation, inhibiting and reducing atherosclerotic plaques, etc., and is used for treating diabetic atherosclerosis.

[0005] To achieve the above-mentioned purpose, the technical solutions of the present application are as follows:

[0006] A traditional Chinese medicine composition is prepared from the following raw materials in the weight parts: Radix Astragali 4.5-18 parts, female ligustrum fruit 3-12 parts, acanthopanax 4.5-18 parts, Radix Salviae Miltiorrhizae 3.5-14 parts, Radix Paeoniae Rubra 4-16 parts, Rhizoma Chuanxiong 3.5-14 parts, Fructus Crataegi 4.5-18 parts, Safflower 3-12 parts, Panax notoginseng 2.5-10 parts, Caulis Spatholobi 5-20 parts, Radix Puerariae 4-16 parts. The above-mentioned raw materials are Chinese medicinal materials or pieces recorded in the Pharmacopoeia of the People's Republic of China.

[0007] Preferably, a traditional Chinese medicine composition is prepared from the following raw materials in the weight parts: Radix Astragali 9 parts, female ligustrum fruit 6 parts, acanthopanax 9 parts, Radix Salviae Miltiorrhizae 7 parts, Radix Paeoniae Rubra 8 parts, Rhizoma Chuanxiong 7 parts, Fructus Crataegi 9 parts, Safflower 6 parts, Panax notoginseng 5 parts, Caulis Spatholobi 10 parts, Radix Puerariae 8 parts.

[0008] The preparation method of the above-mentioned traditional Chinese medicine composition comprises the following steps:

[0009] (1) The weight parts of each raw material are weighed;

[0010] (2) Panax notoginseng is pulverized into fine powder;

[0011] (3) Radix Astragali, female ligustrum fruit, acanthopanax, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Fructus Crataegi, Safflower, Caulis Spatholobi, and Radix Puerariae are cut into slices or broken into pieces and then mixed, and water is added for decoction three times, 7-9 times the amount of water is added for decoction for 1-3 hours for the first time, 5-7 times the amount of water is added for decoction for 1-3 hours for the second time, and 3-5 times the amount of water is added for decoction for 0.5-2 hours for the third time, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.15-1.25 at 60℃;

[0012] (4) The thick paste prepared in step (3) and the Panax notoginseng powder prepared in step (2) are mixed uniformly, vacuum dried, and pulverized into fine powder, thereby obtaining the traditional Chinese medicine composition.

[0013] The traditional Chinese medicine composition in the above-mentioned technical solution is used for preparing a medicine for treating diabetic atherosclerosis.

[0014] A traditional Chinese medicine preparation comprises a traditional Chinese medicine composition and a pharmaceutically acceptable carrier.

[0015] The traditional Chinese medicine preparation in the above-mentioned technical solution, wherein the weight parts of the pharmaceutically acceptable carrier are 1-100 parts relative to the Chinese medicinal materials.

[0016] As an improvement to the traditional Chinese medicine preparation in the above-mentioned technical solution, the pharmaceutically acceptable carrier is one or a combination of several selected from starch, cellulose, starch derivatives, and cellulose derivatives.

[0017] The weight parts of the pharmaceutically acceptable carrier in the traditional Chinese medicine preparation of the present application are 1-100 parts, and the amount and type of the carrier added do not affect the effect of the traditional Chinese medicine preparation on treating diabetic atherosclerosis. The weight parts of the carrier herein have the same meaning as the weight parts of the traditional Chinese medicinal materials in the traditional Chinese medicine composition, i.e., the traditional Chinese medicine preparation comprises 4.5-18 parts of Radix Astragali, 3-12 parts of Fructus Ligustri Lucidi, 4.5-18 parts of Acanthopanax, 3.5-14 parts of Radix Salviae Miltiorrhizae, 4-16 parts of Radix Paeoniae Rubra, 3.5-14 parts of Rhizoma Chuanxiong, 4.5-18 parts of Fructus Crataegi, 3-12 parts of Flos Carthami, 2.5-10 parts of Panax Notoginseng, 5-20 parts of Caulis Spatholobi, 4-16 parts of Radix Puerariae, and 1-100 parts of the pharmaceutically acceptable carrier.

[0018] The preparation method of the traditional Chinese medicine preparation described above comprises the following steps:

[0019] (1) weighing the weight parts of each raw material;

[0020] (2) crushing Panax Notoginseng into fine powder;

[0021] (3) mixing and crushing Radix Astragali, Fructus Ligustri Lucidi, Acanthopanax, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Fructus Crataegi, Flos Carthami, Caulis Spatholobi, and Radix Puerariae, and then decocting them three times, adding 7-9 times the amount of water for the first time, decocting for 1-3 hours, adding 5-7 times the amount of water for the second time, decocting for 1-3 hours, adding 3-5 times the amount of water for the third time, decocting for 0.5-2 hours, filtering, and concentrating the filtrate to a thick paste with a relative density of 1.15-1.25 at 60℃;

[0022] (4) mixing the thick paste prepared in step (3) and the Panax Notoginseng powder prepared in step (2), vacuum drying, crushing into fine powder, adding an appropriate amount of the pharmaceutically acceptable carrier, mixing, granulating, drying, and obtaining the traditional Chinese medicine preparation.

[0023] The present application can be prepared into various dosage forms such as granules, tablets, and capsules according to the type of the added auxiliary material and the preparation method used. The present application can also directly decoct the mixture of each traditional Chinese medicine in the traditional Chinese medicine composition to obtain a traditional Chinese medicine decoction.

[0024] The preparation method of the traditional Chinese medicine preparation described in the above technical solution, wherein the pharmaceutically acceptable carrier is one or a combination of several selected from starch, cellulose, starch derivatives, and cellulose derivatives.

[0025] The use of the traditional Chinese medicine preparation described in any of the above technical solutions in the preparation of a drug for treating diabetic atherosclerosis.

[0026] Diabetes (consumption) for a long time, deficiency of both qi and yin, deficiency of both qi and yin, blood flow caused by blood stasis, block the meridians, blood circulation, and the basic pathogenesis of diabetic atherosclerosis. Therefore, deficiency of both qi and yin and blood stasis are the main causes of the occurrence and aggravation of diabetic atherosclerosis, and run through the whole process of diabetic atherosclerosis. According to the theory of TCM qi and blood, Huangqi is matched with Nuzhensizi and Ciwujia as the monarch drug, which is mainly in tonifying primordial qi, benefiting qi and nourishing yin, making qi strong and blood flow, and tonifying deficiency of both qi and yin caused by long-term consumption; Danshen, Chishao, Chuanxiong, Shanzha and Honghua are used as the ministerial drug, which can activate blood, remove blood, promote blood circulation, remove blood stasis, and dredge collaterals; Sanqi and Jixueteng are used as the auxiliary drug, which can assist in promoting blood circulation and activating blood, and also can nourish blood and restore the body, so as to promote the generation of new blood after removing blood stasis, and tonify the deficiency of blood vessels; Gegen is used as the ministerial drug, which can generate fluid to stop thirst, dredge the channels and activate the collaterals, treat various arthralgia, and resolve the exterior and open the interior. The combination of various drugs can restore the patient's qi and blood, remove blood stasis and blockage, and dredge the collaterals, so as to eliminate or alleviate the symptoms.

[0027] The traditional Chinese medicine composition and its preparation have the effects of reducing blood lipids, resisting inflammation, inhibiting and reducing atherosclerotic plaques, and can effectively treat diabetic atherosclerosis disease. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 is a representative picture of aortic oil red O gross staining;

[0029] Figure 2 is a representative picture of aortic paraffin section HE staining;

[0030] Figure 3 is a representative picture of aortic paraffin section Masson staining. DETAILED DESCRIPTION

[0031] The technical solutions of the present application will be described in detail below in combination with the drawings and examples.

[0032] Example 1

[0033] Huangqi 4.5g, Nuzhensizi 3g, Ciwujia 4.5g, Danshen 3.5g, Chishao 4g, Chuanxiong 3.5g, Shanzha 4.5g, Honghua 3g, Sanqi 2.5g, Jixueteng 5g, Gegen 4g. The above raw medicinal materials, Sanqi is crushed into fine powder; the rest of Huangqi, Ciwujia, Danshen, Chishao, Chuanxiong, Shanzha, Honghua, Jixueteng and Gegen are cut into slices and broken, mixed, and decocted with water for three times, the first time is decocted with 8 times the amount of water for 2 hours, filtered, the residue is decocted with 6 times the amount of water for 2 hours, filtered, the residue is decocted with 4 times the amount of water for 1 hour, filtered, the filtrate is concentrated to a thick paste with a relative density of 1.15-1.25 at 60°C; the thick paste and Sanqi powder are mixed uniformly, vacuum dried, and crushed into fine powder, to obtain 12.9g of traditional Chinese medicine composition as the adult daily dosage.

[0034] Example 2

[0035] Radix Astragali seu Hedysari 9 parts, Fructus Ligustri Lucidi 6 parts, Radix Acanthopanacis Senticosi 9 parts, Radix Salviae Miltiorrhizae 7 parts, Radix Paeoniae Rubrae 8 parts, Rhizoma Chuanxiong 7 parts, Fructus Crataegi 9 parts, Flos Carthami 6 parts, Radix Notoginseng 5 parts, Caulis Spatholobi 10 parts, Radix Puerariae 8 parts. The above raw medicinal materials, Radix Notoginseng is crushed into fine powder; the rest, Radix Astragali seu Hedysari, Radix Acanthopanacis Senticosi, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubrae, Rhizoma Chuanxiong, Flos Carthami, Caulis Spatholobi, Fructus Ligustri Lucidi, Fructus Crataegi are cut into slices, and then mixed, water decocting for three times, the first time adding 8 times of water of the total weight of medicinal materials decocting for 2 hours, filtering, the residue adding 6 times of water decocting for 2 hours, filtering, the residue adding 4 times of water decocting for 1 hour, filtering, the filtrate is concentrated to the thick paste with the relative density of 1.15-1.25 at 60℃; the thick paste and Radix Notoginseng powder are mixed uniformly, vacuum drying, crushing into fine powder, 10g of dextrin is added, mixing, granulating with 75% ethanol, drying, and then the granules are pressed into tablets, and the tablet is obtained.

[0036] Example 3

[0037] Radix Astragali seu Hedysari 9 parts, Fructus Ligustri Lucidi 6 parts, Radix Acanthopanacis Senticosi 9 parts, Radix Salviae Miltiorrhizae 7 parts, Radix Paeoniae Rubrae 8 parts, Rhizoma Chuanxiong 7 parts, Fructus Crataegi 9 parts, Flos Carthami 6 parts, Radix Notoginseng 5 parts, Caulis Spatholobi 10 parts, Radix Puerariae 8 parts. The above raw medicinal materials, Radix Notoginseng is crushed into fine powder; the rest, Radix Astragali seu Hedysari, Radix Acanthopanacis Senticosi, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubrae, Rhizoma Chuanxiong, Flos Carthami, Caulis Spatholobi, Fructus Ligustri Lucidi, Fructus Crataegi are cut into slices, and then mixed, water decocting for three times, the first time adding 8 times of water of the total weight of medicinal materials decocting for 2 hours, filtering, the residue adding 6 times of water decocting for 2 hours, filtering, the residue adding 4 times of water decocting for 1 hour, filtering, the filtrate is concentrated to the thick paste with the relative density of 1.15-1.25 at 60℃; the thick paste and Radix Notoginseng powder are mixed uniformly, vacuum drying, crushing into fine powder, 10g of dextrin is added, mixing, granulating with 75% ethanol, drying, and then the granules are pressed into tablets, and the tablet is obtained.

[0038] Example 4

[0039] Radix Astragali seu Hedysari 9 parts, Fructus Ligustri Lucidi 6 parts, Radix Acanthopanacis Senticosi 9 parts, Radix Salviae Miltiorrhizae 7 parts, Radix Paeoniae Rubrae 8 parts, Rhizoma Chuanxiong 7 parts, Fructus Crataegi 9 parts, Flos Carthami 6 parts, Radix Notoginseng 5 parts, Caulis Spatholobi 10 parts, Radix Puerariae 8 parts. The above raw medicinal materials, Radix Notoginseng is crushed into fine powder; the rest, Radix Astragali seu Hedysari, Radix Acanthopanacis Senticosi, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubrae, Rhizoma Chuanxiong, Flos Carthami, Caulis Spatholobi, Fructus Ligustri Lucidi, Fructus Crataegi are cut into slices, and then mixed, water decocting for three times, the first time adding 8 times of water of the total weight of medicinal materials decocting for 2 hours, filtering, the residue adding 6 times of water decocting for 2 hours, filtering, the residue adding 4 times of water decocting for 1 hour, filtering, the filtrate is concentrated to the thick paste with the relative density of 1.15-1.25 at 60℃; the thick paste and Radix Notoginseng powder are mixed uniformly, vacuum drying, crushing into fine powder, 10g of dextrin is added, mixing, granulating with 75% ethanol, drying, and then the granules are pressed into tablets, and the tablet is obtained.

[0040] The following further illustrates the beneficial effects of the traditional Chinese medicine composition of the present application in preparing a medicament for treating diabetic atherosclerosis through specific test examples:

[0041] 1. Diabetic atherosclerosis modeling

[0042] ApoE- / - gene knockout mice were fed with high-fat feed for 6 weeks, then fasted for 12 hours but not restricted from drinking, and then intraperitoneal injection of STZ citric acid buffer was started for diabetic modeling. C57 mice were used as a control group. The model group mice were intraperitoneally injected with STZ citric acid buffer at a dose of 40 mg / kg once a day for 5 consecutive days. The control group mice were intraperitoneally injected with citric acid buffer at a dose of 10 mL / kg once a day for 4 consecutive days. After 10 days of injection, the fasting blood glucose value was measured to be > 11.1 mmol / L and the symptoms of polydipsia, polyphagia, and polyuria appeared, which was considered as successful modeling.

[0043] Preparation method of citric acid buffer:

[0044] Preparation of citric acid-sodium citrate buffer: The buffer is divided into A liquid and B liquid, which must be prepared immediately before use. A liquid: accurately weigh 0.735 g of sodium citrate and dissolve in 25 mL of sterile ultrapure water; B liquid: accurately weigh 0.525 g of citric acid and dissolve in 25 mL of sterile ultrapure water. Mix equal volumes of the well-dissolved A liquid and B liquid, and then adjust the pH to 4.2-4.5.

[0045] Preparation method of STZ citric acid buffer:

[0046] According to the use dose of 40 mg / Kg, STZ (streptozotocin) was weighed, and 0.004 g of STZ was dissolved in 1 mL of the above-mentioned citric acid-sodium citrate buffer in the dark, placed on ice, and gently mixed to prepare a STZ solution with a concentration of 4 mg / mL. Ensure that the entire operation is carried out on ice bath, and prepare it immediately before use (within 30 minutes of injection), and avoid light.

[0047] 2. Grouping

[0048] After the success of modeling, according to blood glucose and body weight, the diabetic mice with atherosclerosis model group were randomly divided into model group, atorvastatin calcium group (clinical 20 mg / human / day converted into mouse equivalent dose of 3 mg / kg / day), Chinese medicine composition small dose, medium dose, large dose group (doses correspond to the Chinese medicine composition described in Example 1, Example 2, Example 3, converted into mouse equivalent dose of 1.8 g / kg / day, 3.6 g / kg / day, 7.2 g / kg / day), each group of 20 (after modeling, there is a certain mortality and failure rate, ensure that each group of at least 15 mice). The control group of mice was continued to be fed with ordinary feed, and the rest of the mice in each group were continued to be fed with high-fat feed, and at the same time, drug intervention was carried out, once a day, the drug was dissolved in appropriate water and continuously administered by gavage for 11 weeks, and the administration volume was 20 mL / kg / day.

[0049] 3. Specimen collection:

[0050] Blood collection: After the end of administration in each group, the mice were taken blood from the medial canthus vein, mixed in the test tube containing EDTA-K2 anticoagulant, centrifuged at 4℃, 3000 r / min for 15 min, and the upper plasma was taken and stored at-80℃ for standby.

[0051] Collection of aortic tissue: After blood collection, the mice were sacrificed, the chest was opened along the chest midline, the heart and thoracic aorta were fully exposed, perfusion was performed from the apex of the heart with sterile PBS solution, and the liver was slowly injected for about 5-10 min until it turned white. Then the complete aorta and heart exposed on the left front side of the spine were gently stripped of the fat tissue around the aorta, the branches issuing during the aortic course were carefully cut off, the complete gross vascular specimen and heart were separated from the aortic arch to the iliac artery bifurcation, 1 / 3 of the aorta was subjected to oil red gross staining, 1 / 3 of the aortic arch was fixed by immersion in 4% paraformaldehyde, and the remaining 1 / 3 of the aorta was stored at-80℃ for standby.

[0052] 4. Pharmacodynamic evaluation

[0053] 4.1 Blood lipid index determination, detection of plasma TCHO (total cholesterol), TG (total glycerol triester), LDL (low density lipoprotein), HDL (high density lipoprotein), and lipoprotein B content.

[0054] 4.2 Inflammatory factor detection

[0055] ELISA method was used to detect multiple inflammatory factors in mouse plasma, including IL-4, IL-17, TNF-α, IL-6, IL-1β, IL-10, etc.

[0056] 4.3 Aortic gross oil red O staining, aortic arch Masson staining, HE staining of aortic arch section, detection of aortic plaque distribution and lesion degree.

[0057] 5. Test results

[0058] 5.1 Blood lipid indicators

[0059] As shown in Table 1, after 11 weeks of administration, the blood lipid indicators of each dose group of the traditional Chinese medicine formula were greatly improved compared with the model group. Compared with the control group, the triglyceride (TG) content of the model group was significantly increased (P < 0.01), and the TG content of the small and medium dose groups of the traditional Chinese medicine formula was significantly lower than that of the model group (P < 0.05). At the same time, the total cholesterol (TCHO) content of the model group was significantly increased (P < 0.001), and the TCHO content of the medium dose group of the traditional Chinese medicine formula was significantly lower than that of the model group (P < 0.05). There was no significant difference in the high-density lipoprotein (HDL) content of each group, the low-density lipoprotein (LDL) content of the model group was higher than that of the control group (P < 0.001), and the LDL content of the medium dose group of the traditional Chinese medicine formula and the atorvastatin calcium treatment group was significantly lower than that of the model group (P < 0.05). The apolipoprotein B (ApoB) content of the model group was significantly higher than that of the control group (P < 0.001), and the ApoB content of the medium dose group of the traditional Chinese medicine formula was significantly lower than that of the model group (P < 0.05). In summary, the blood lipid indicators of the diabetic atherosclerosis model mice were significantly higher than those of the control group, and the traditional Chinese medicine formula significantly improved the hyperlipidemia condition of the model mice and had the effect of lowering blood lipids.

[0060] Table 1 Detection of blood lipid indicators of APOE+-mice with diabetic atherosclerosis by traditional Chinese medicine composition (x ± s, n = 10)

[0061]

[0062] Note: Compared with the model group, #P < 0.05, ##P < 0.01, ###P < 0.001.

[0063] 5.2 Inflammatory factor indicators

[0064] Diabetic atherosclerosis is a multifactorial disease, inflammation mediates the whole process of its occurrence and development, and inflammatory markers have become the main indicators of atherosclerosis stability and prognosis. As shown in Table 2, compared with the control group, the IL-4 (regulating humoral immunity and adaptive immunity), IL-17 (a pro-inflammatory cytokine mainly produced by activated T cells), IL-1β (can attract neutrophils, cause inflammatory mediator release, etc.), IL-2 (inducing cytotoxicity, promoting inflammatory response), IL-6 (inflammatory effector factor), mouse growth-regulating oncogene alpha (KC), IL-10 (inhibiting mononuclear macrophage release of inflammatory mediators, enhancing release of anti-inflammatory factors), TNF-α (inflammatory effector factor), IL-23p19 (promoting INF-γ production) and monocyte chemotactic protein (MCP-1) (promoting inflammatory factor secretion) in the model group were significantly increased (P<0.05, P<0.001), suggesting that when diabetic atherosclerosis occurs, the body is in a state of obvious inflammation activation. After treatment with the traditional Chinese medicine formula, the above inflammatory indicators in the mice had a decreasing trend (IL-10 had an increasing trend), among which the IL-4, IL-23p19 and MCP-1 in the medium dose group decreased significantly (P<0.05), and the IL-10 level was significantly higher than that in the model group (P<0.05), all of which indicated that the traditional Chinese medicine formula had a significant anti-inflammatory effect.

[0065] Table 2 Effects of traditional Chinese medicine composition on diabetic atherosclerosis model APOE+-mice

[0067] In vivo inflammatory factor content detection (x±s, n=12)

[0068]

[0069] Note: Compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0070] 5.3 Aortic oil red O gross observation and HE, Masson staining

[0071] From Figure 1 ( Figure 1Model group, B, C, D are small, medium and large dose groups of the traditional Chinese medicine composition, E is atorvastatin calcium group, F is the control group) can be known, the vascular wall fat plaque is dyed red by oil red O, the relative area of aortic plaque formation in each group is compared by calculating the percentage of plaque total area to the total intimal area; as shown in Table 3, the plaque area of the model group is significantly higher than that of the control group (P<0.001), which indicates that the atherosclerosis model is successfully established. The percentage of plaque area to total vascular intimal area in each dose group of the traditional Chinese medicine composition has a decreasing trend, and the large dose group is significantly reduced (P<0.05). In addition, the mouse aortic arch cross section is stained by HE, and after staining, the photograph is observed under a light microscope, and it can be seen that Figure 2 ( Figure 2 Model group, B, C, D are small, medium and large dose groups of the traditional Chinese medicine composition, E is atorvastatin calcium group, F is the control group); the lumen area and plaque area are calculated by Image J software, and the relative size of the plaque is the total plaque area divided by the lumen area, and as shown in Table 3, the plaque area percentage of the aortic arch of the model group mice is significantly higher than that of the control group (P<0.001), and the plaque area percentage of the aortic arch of the traditional Chinese medicine composition in each dose group has a decreasing trend. Masson's trichrome staining is a classic collagen fiber staining technique that can distinguish collagen fibers and muscle fibers. After staining, muscle fibers are red and collagen fibers are blue, which can be used to evaluate the collagen content in the plaque, and it can be seen that Figure 3 ( Figure 3 Model group, B, C, D are small, medium and large dose groups of the traditional Chinese medicine composition, E is atorvastatin calcium group, F is the control group); it is generally believed that the higher the relative content of collagen in the plaque, the more stable the plaque, and as shown in Table 3, the collagen content of the model group is significantly higher than that of the control group (P<0.001), and the collagen content of the plaque in each group of the traditional Chinese medicine composition has a decreasing trend compared with the model group.

[0072] Table 3 Pathological staining results of traditional Chinese medicine composition on aortic pathological staining of diabetic atherosclerosis model APOE+ mice (x±s, n=6)

[0073]

[0074] Note: compared with the model group, #P<0.05, ##P<0.01, ###P<0.001.

[0075] The experimental research proves that the small, medium and large dose groups have effects, especially the medium dose group, which is not worse than the atorvastatin calcium group, especially the TG and ApoB in the blood lipid indexes, the IL-10, IL-23p19 and MCP-1 in the inflammatory factor indexes, and the aortic arch cross-section plaque area proportion indexes of each dose group are all better than those of the atorvastatin calcium group. The traditional Chinese medicine composition has the effects of significantly reducing blood lipid, resisting inflammation, inhibiting and reducing the formation of the atherosclerotic plaque, etc., thereby being capable of effectively treating the diabetic atherosclerotic diseases.

[0076] The contents not described in detail in the present application can adopt the conventional technical knowledge in the field.

[0077] Finally, it should be explained that the above examples are only used to illustrate the technical solutions of the present application but not limit the present application. Although the present application is described in detail with reference to the examples, those skilled in the art should understand that the modification or equivalent replacement of the technical solutions of the present application does not deviate from the spirit and scope of the present application, and should be covered in the scope of the claims of the present application.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 4.5-18 parts of Astragalus, 3-12 parts of female ligustrum fruit, 4.5-18 parts of acanthopanax, 3.5-14 parts of salvia, 4-16 parts of red peony root, 3.5-14 parts of chuanxiong, 4.5-18 parts of hawthorn, 3-12 parts of safflower, 2.5-10 parts of panax notoginseng, 5-20 parts of caulis Bambusae, and 4-16 parts of pueraria.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9 parts of Astragalus, 6 parts of female ligustrum fruit, 9 parts of acanthopanax, 7 parts of salvia, 8 parts of red peony root, 7 parts of chuanxiong, 9 parts of hawthorn, 6 parts of safflower, 5 parts of panax notoginseng, 10 parts of caulis Bambusae, and 8 parts of pueraria.

3. A preparation method of the traditional Chinese medicine composition of claim 1 or 2, comprising the following steps: (1) weighing the raw materials in the parts by weight; (2) grinding panax notoginseng into fine powder; (3) mixing and crushing female ligustrum fruit, acanthopanax, salvia, red peony root, chuanxiong, hawthorn, safflower, caulis Bambusae, and pueraria, and then decocting them three times with water, adding 7-9 times of water for the first time and decocting for 1-3 hours, adding 5-7 times of water for the second time and decocting for 1-3 hours, and adding 3-5 times of water for the third time and decocting for 0.5-2 hours, filtering, and concentrating the filtrate to a thick paste with a relative density of 1.15-1.25 at 60°C; (4) mixing the thick paste prepared in step (3) and the panax notoginseng powder prepared in step (2), vacuum drying, and grinding into fine powder to obtain the traditional Chinese medicine composition.

4. A traditional Chinese medicine preparation comprising a traditional Chinese medicine composition and a pharmaceutically acceptable carrier, characterized in that, The traditional Chinese medicine composition is the traditional Chinese medicine composition of any one of claims 1-3.

5. The traditional Chinese medicine preparation according to claim 4, characterized in that, The pharmaceutically acceptable carrier is in parts by weight of 1-100 parts.

6. The traditional Chinese medicine preparation according to claim 4, characterized in that, The dosage form of the traditional Chinese medicine preparation is granules or tablets.

7. The traditional Chinese medicine preparation according to any one of claims 4-6, characterized in that, The pharmaceutically acceptable carrier is one or a combination of several selected from starch, cellulose, starch derivatives, and cellulose derivatives.

8. A preparation method of the traditional Chinese medicine preparation of any one of claims 4-6, comprising the following steps: After extracting the traditional Chinese medicine composition, adding an appropriate amount of pharmaceutically acceptable carrier, mixing, granulating, and drying to obtain the traditional Chinese medicine preparation.

9. Use of the traditional Chinese medicine composition of any one of claims 1-2 or the traditional Chinese medicine preparation of any one of claims 4-7 in the preparation of a medicine for treating diabetic atherosclerosis.

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