A traditional Chinese medicine preparation for treating coronary heart disease and a preparation method thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a traditional Chinese medicine preparation for treating coronary heart disease and a preparation method thereof. The traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 22-28 parts of Astragalus membranaceus, 20-25 parts of Prenanthes altissima, 13-18 parts of Panax notoginseng, 10-15 parts of small Rhododendron, 8-13 parts of Radix Paeoniae Rubra, 7-12 parts of Allium macrostemon, and 3-8 parts of Glycyrrhiza uralensis. In the traditional Chinese medicine preparation, Astragalus membranaceus and Prenanthes altissima are the monarch drugs for tonifying qi and promoting blood circulation; Panax notoginseng and small Rhododendron are the minister drugs for activating blood and dispelling wind; Radix Paeoniae Rubra and Allium macrostemon are the auxiliary drugs for clearing heat and cooling blood and for dredging yang and resolving stasis; and Glycyrrhiza uralensis is the ministerial drug for regulating all drugs. The traditional Chinese medicine preparation has the functions of tonifying qi, activating blood, dredging collaterals and relieving pain, and has the effects of improving blood circulation, regulating blood fat and preventing blood stasis, thereby providing important guiding significance for the treatment of coronary heart disease and the development of drugs.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine preparation for treating coronary heart disease and a preparation method thereof. BACKGROUND

[0002] Coronary heart disease (CHD) is a common heart disease characterized by the accumulation of plaque in the coronary arteries, leading to narrowing or complete occlusion of the vessel lumen, and ultimately causing insufficient blood supply, hypoxia, or death of myocardial tissue. Coronary heart disease is one of the most common cardiovascular diseases worldwide and is an important cause of death and disability.

[0003] The pathogenesis of coronary heart disease is complex, and the main cause is coronary atherosclerosis, which is the result of the combined action of multiple different risk factors. The main causes include high blood lipids, especially elevated low-density lipoprotein cholesterol, which is the main cause of atherosclerosis; secondly, high blood pressure increases the workload of the heart and promotes the development of atherosclerosis; at the same time, diabetes mellitus, due to hyperglycemia, causes damage to the vascular endothelium, greatly increasing the risk of atherosclerosis; in addition, in recent years, people's living standards have improved, and obesity and lack of exercise caused by dietary habits can increase the risk of coronary heart disease.

[0004] In traditional Chinese medicine, coronary heart disease belongs to the category of "chest pain" and "palpitations". The basic pathogenesis is considered in "Synopsis of Golden Chamber" as being based on deficiency and manifested in excess, with spleen deficiency as the root of the disease, blood stasis as the excess, and phlegm turbidity as the main manifestation. With the increasing problem of aging in China, the incidence of coronary heart disease is increasing year by year, and there is a clear trend of younger patients. The treatment of this disease has also attracted the attention of medical staff, and as a hot issue in the medical field, western medicine is currently used in the treatment of coronary heart disease in clinical practice, although the efficacy is satisfactory, but long-term western medicine treatment can lead to poor tolerance, strong drug resistance, and severe adverse reactions, such as long-term use of aspirin can cause gastrointestinal bleeding and other adverse reactions, and use of statins can cause liver damage and other adverse reactions. Traditional Chinese medicine has unique advantages and prospects in clinical prevention and treatment due to its syndrome differentiation and treatment and multiple pathways and targets, especially in improving lipid metabolism, preventing and treating cardiovascular diseases, accumulating rich experience in improving lipid metabolism, preventing and treating cardiovascular diseases, adjusting the internal environment of the body, regulating the balance of qi and blood, and reducing the occurrence of adverse reactions, thereby achieving the purpose of preventing and treating coronary heart disease. Therefore, it is of great practical significance to develop a traditional Chinese medicine preparation for treating coronary heart disease. SUMMARY

[0005] The first object of the present application is to provide a traditional Chinese medicine preparation for treating coronary heart disease.

[0006] The second object of the present application is to provide a preparation method of the Chinese medicine preparation for treating coronary heart disease.

[0007] To achieve the above object, the technical solution adopted by the present application is:

[0008] The Chinese medicine preparation for treating coronary heart disease comprises the following raw materials by weight: 22-28 parts of Radix Astragali, 20-25 parts of Prenanthes Chinensis, 13-18 parts of Panax Notoginseng, 10-15 parts of Small Ligusticum, 8-13 parts of Radix Paeoniae Rubra, 7-12 parts of Allium Macrostemon, and 3-8 parts of Radix Glycyrrhizae.

[0009] Further, the Chinese medicine preparation for treating coronary heart disease comprises the following raw materials by weight: 25 parts of Radix Astragali, 20 parts of Prenanthes Chinensis, 13 parts of Panax Notoginseng, 10 parts of Small Ligusticum, 8 parts of Radix Paeoniae Rubra, 11 parts of Allium Macrostemon, and 5 parts of Radix Glycyrrhizae.

[0010] The present application provides a preparation method of the Chinese medicine preparation for treating coronary heart disease, comprising the following steps:

[0011] (1) Prenanthes Chinensis, Panax Notoginseng, and Small Ligusticum are weighed according to the weight ratio of the Chinese medicine preparation, then soaked in water, heated for extraction, filtered, and water extract is obtained;

[0012] (2) Radix Astragali, Radix Paeoniae Rubra, Allium Macrostemon, and Radix Glycyrrhizae are weighed according to the weight ratio of the Chinese medicine preparation, then soaked in water, heated for extraction, filtered, and water extract is obtained;

[0013] (3) The water extracts obtained in steps (1) and (2) are combined, ethanol is added and refrigerated, then ethanol is recovered, the extract is concentrated, pharmaceutically acceptable excipients are added, and the Chinese medicine preparation is prepared.

[0014] Further, in step (1), the amount of water added is 8-10 times the total mass of Prenanthes Chinensis, Panax Notoginseng, and Small Ligusticum;

[0015] Further, in step (1), the soaking time is 2-4 h, the heating extraction temperature is 80-100°C, and the time is 1.5-3 h; the heating extraction is performed 2-3 times.

[0016] Further, in step (2), the amount of water added is 8-12 times the total mass of Radix Astragali, Radix Paeoniae Rubra, Allium Macrostemon, and Radix Glycyrrhizae,

[0017] Further, in step (2), the soaking time is 2-4 h, the heating extraction temperature is 80-100°C, and the time is 2-3 h; the heating extraction is performed 2-3 times.

[0018] Further, in step (3), ethanol is added to make the alcohol content 40-80 w / v%.

[0019] Furthermore, in step (3), the relative density of the extract is 1.1-1.5.

[0020] Furthermore, the dosage form of the traditional Chinese medicine preparation is any one of oral liquid, tablet, pill, granule or capsule.

[0021] The medicinal properties and efficacy of each raw material in the traditional Chinese medicine preparation of this invention are described below:

[0022] Astragalus: Also known as Mianhuangqi; it is the dried root of Astragalus membranaceus or Astragalus mongholicus, both belonging to the genus Astragalus of the legume family. It has a sweet taste and slightly warm nature, and enters the spleen and lung meridians. It has the effects of strengthening the spleen and replenishing the middle jiao, raising yang and lifting prolapse, benefiting wei qi and consolidating the exterior, promoting diuresis and reducing swelling, and promoting tissue regeneration and detoxification. The *Xiao'er Weisheng Zongwei Lunfang* records: For treating urinary retention in children, grind Mianhuangqi into powder. Take one qian (approximately 3 grams) each time, decoct with one cup of water until reduced to half, and take warm at any time.

[0023] *Houttuynia cordata*: The whole herb of *Houttuynia cordata*, a plant in the Asteraceae family. It is bitter, pungent, and cool in nature. It enters the liver and lung meridians. It has the functions of clearing heat and detoxifying, relieving cough and promoting qi circulation and blood flow. It is mainly used to treat colds and coughs, stomach distension and pain, diarrhea, dysentery, edema, urinary tract infections, boils and carbuncles, traumatic swelling and pain, snake bites, and other ailments. *Min Dong Ben Cao* records that it removes dampness, promotes qi circulation, promotes urination, and clears the meridians and breaks up blood stasis. It treats edema, abdominal distension, hernia, unilateral prolapse, jaundice, amenorrhea, food stagnation, lower back and hip pain, and urinary retention.

[0024] Panax notoginseng: The dried root of Panax notoginseng, a plant in the Araliaceae family. It is sweet and slightly bitter in nature, and warm in nature. It enters the liver, stomach, and large intestine meridians. It has the effects of resolving blood stasis, stopping bleeding, promoting blood circulation, and relieving pain. It is mainly used to treat bleeding disorders, traumatic injuries, and swelling and pain due to blood stasis. The Compendium of Materia Medica records: "For stopping bleeding, dispersing blood stasis, and relieving pain, for wounds from metal blades and arrows, falls, and beatings, where bleeding is persistent, chew it and apply it, or grind it into powder and sprinkle it on the wound; the bleeding will stop immediately."

[0025] Small Umbrella Tree: The root or whole plant of *Ardisia crenata*, a plant in the Myrsinaceae family. It tastes bitter, sweet, and pungent, and is warm in nature. It enters the liver, bladder, and kidney meridians. It has the effects of promoting blood circulation and regulating menstruation, dispelling wind and dampness. It is mainly used to treat rheumatic pain and traumatic injuries. The *Handbook of Commonly Used Chinese Herbal Medicines* records that it dispels wind and disperses blood stasis, reduces swelling and relieves pain. It is used to treat rheumatoid arthritis and traumatic injuries.

[0026] Red peony root: The dried root of Paeonia lactiflora or Paeonia veitchii, both belonging to the Ranunculaceae family. Harvested in spring and autumn, the rhizomes, fibrous roots, and soil are removed, and then it is sun-dried. Slightly cold in nature and bitter in taste. It enters the liver and spleen meridians. Functions and indications: Clears heat and cools the blood, invigorates blood and removes blood stasis. The *Shennong Bencao Jing* records: It treats abdominal pain caused by pathogenic factors, eliminates blood stasis, breaks up hard masses, treats hernia due to cold and heat, relieves pain, promotes urination, and invigorates qi.

[0027] Allium macrostemon: a perennial herb belonging to the genus Allium in the Amaryllidaceae family. It is pungent, bitter, and warm in nature; it enters the lung, stomach, and large intestine meridians. It has the effects of promoting yang, dispersing stagnation, regulating qi, and relieving stagnation. The *Bielu* records: "It enters the bones. It removes cold and heat, eliminates water retention, warms the middle jiao, and disperses stagnation. It is used topically for various sores, wind-cold, and edema."

[0028] Glycyrrhiza: sweet, flat, spleen, stomach, heart, lung. With and moderate, lung, detoxification, and the effect of harmonizing drugs. Benjing records: the main five internal organs, six internal organs, cold, evil, strong bones, muscle, double force, gold, swelling, detoxification.

[0029] Compared with the prior art, the beneficial effects of the present application mainly lie in:

[0030] 1. The present application provides a traditional Chinese medicine preparation for treating coronary heart disease, in which Huangqi and Maodangcao are used as the monarch drug, Huangqi can tonify qi, raise yang, produce fluid and nourish blood, and supplement qi and consolidate the exterior, and Maodangcao can activate qi and promote blood circulation; Sanqi and Xiaoluosan are used as the ministerial drug, Sanqi can stop bleeding, remove blood stasis, and dissipate swelling and relieve pain, and Xiaoluosan can activate blood and dispel wind; Chishao and Xiebai are used as the auxiliary drug, Chishao can clear heat and cool blood, and Xiebai can activate yang, relieve stagnation, and promote qi and remove stagnation; and Gancao is used as the ministerial drug to harmonize all drugs. The components of the traditional Chinese medicine preparation of the present application are well matched, and have a synergistic effect, and have the effects of tonifying qi, activating blood, dredging collaterals, and relieving pain, and also have the effects of improving blood circulation, regulating blood lipids, resisting inflammation, and preventing blood stasis, which provides important guidance for the treatment of coronary heart disease and the development of drugs.

[0031] 2. The present application provides a preparation method of the traditional Chinese medicine preparation for treating coronary heart disease, which is simple, convenient to operate, can maximize the effective components of the raw materials, and has high safety and stable curative effect. DETAILED DESCRIPTION

[0032] The technical solutions of the present application are further described below in combination with specific embodiments. However, those skilled in the art should understand that the following examples are only used to illustrate the present application, and should not be regarded as limiting the present application. The specific conditions not mentioned in the examples are carried out according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments used, such as those not specifically mentioned, are conventional products obtained through market channels.

[0033] Example 1

[0034] The present embodiment provides a traditional Chinese medicine preparation for treating coronary heart disease, which comprises the following raw materials by weight: Huangqi 25 parts, Maodangcao 20 parts, Sanqi 13 parts, Xiaoluosan 10 parts, Chishao 8 parts, Xiebai 11 parts, and Gancao 5 parts.

[0035] The present embodiment also provides a preparation method of the traditional Chinese medicine preparation for treating coronary heart disease, which comprises the following steps:

[0036] (1) Huangqi, Maodangcao, and Xiaoluosan are weighed according to the weight ratio of the traditional Chinese medicine preparation, and the total mass of the three is added with 9 times the amount of water to soak for 3 h, and then heated at 90°C for 2 h for extraction twice, and filtered with gauze to obtain a water extract;

[0037] (2) Huangqi, Chishao, Xiebai and Gancao were weighed according to the weight ratio of the Chinese medicine preparation, and then soaked in water for 3 h, and extracted for 2 times under heating at 90 °C, each for 2.5 h. The water extract was obtained by filtering with gauze;

[0038] (3) The water extracts obtained in steps (1) and (2) were combined, and ethanol was added to make the alcohol content 60 w / v%. The mixture was refrigerated at 4 °C for 36 h, and then the ethanol was recovered. The extract was concentrated to the extract at 60 °C with a relative density of 1.3. Starch was added in an amount of 0.3% of the mass of the extract, and then dried at 85 °C. The product was crushed to 60 mesh, and then mixed with microcrystalline cellulose and sodium carboxymethyl starch. The microcrystalline cellulose was added in an amount of 0.4% of the mass of the product, and the sodium carboxymethyl starch was added in an amount of 0.4% of the mass of the product. Magnesium stearate was added in an amount of 0.4% of the mass of the product, and then mixed. The mixture was compressed to obtain tablets.

[0039] Example 2

[0040] A Chinese medicine preparation for treating coronary heart disease, comprising the following raw materials by weight: Huangqi 22 parts, Maodangcao 23 parts, Sanqi 15 parts, Xiaoluosan 12 parts, Chishao 10 parts, Xiebai 7 parts, and Gancao 3 parts.

[0041] The present embodiment also provides a preparation method of the Chinese medicine preparation for treating coronary heart disease, comprising the following steps:

[0042] (1) Maodangcao, Sanqi and Xiaoluosan were weighed according to the weight ratio of the Chinese medicine preparation, and then soaked in water for 2 h, and extracted for 3 times under heating at 80 °C, each for 3 h. The water extract was obtained by filtering with gauze.

[0043] (2) Huangqi, Chishao, Xiebai and Gancao were weighed according to the weight ratio of the Chinese medicine preparation, and then soaked in water for 2 h, and extracted for 3 times under heating at 80 °C, each for 3 h. The water extract was obtained by filtering with gauze.

[0044] (3) The water extracts obtained in steps (1) and (2) were combined, and ethanol was added to make the alcohol content 40 w / v%. The mixture was refrigerated at 4 °C for 24 h, and then the ethanol was recovered. The extract was concentrated to the extract at 60 °C with a relative density of 1.1. The dry extract was obtained after drying. The dry extract was crushed to obtain a dry extract powder. Dextrin and sodium carboxymethyl cellulose were added to the dry extract powder (the amount of dextrin was 2% of the mass of the dry extract powder, and the amount of sodium carboxymethyl cellulose was 2% of the mass of the dry extract powder). The mixture was granulated, dried at 90 °C for 5 h, and then made into granules.

[0045] Example 3

[0046] A Chinese medicine preparation for treating coronary heart disease, comprising the following raw materials by weight: 28 parts of Radix Astragali, 25 parts of Herba Prenanthes, 18 parts of Radix Notoginseng, 15 parts of Radix Linderae, 13 parts of Radix Paeoniae Rubra, 12 parts of Bulbus Allii Macrostemi, and 8 parts of Radix Glycyrrhizae.

[0047] The present embodiment also provides a preparation method of the Chinese medicine preparation for treating coronary heart disease as described above, comprising the following steps:

[0048] (1) Herba Prenanthes, Radix Notoginseng, and Radix Linderae are weighed according to the weight ratio of the Chinese medicine preparation, and then soaked in water at 10 times the total mass of the three for 4 hours. The water is heated at 100°C for 2 times, each for 1.5 hours, and then filtered with gauze to obtain a water extract;

[0049] (2) Radix Astragali, Radix Paeoniae Rubra, Bulbus Allii Macrostemi, and Radix Glycyrrhizae are weighed according to the weight ratio of the Chinese medicine preparation, and then soaked in water at 12 times the total mass of the four for 2 hours. The water is heated at 100°C for 2 times, each for 2 hours, and then filtered with gauze to obtain a water extract;

[0050] (3) The water extracts obtained in steps (1) and (2) are combined, and then ethanol is added to make the alcohol content 80 w / v%. The mixture is refrigerated at 4°C for 48 hours, and then the ethanol is recovered. The mixture is concentrated to a relative density of 1.5 at 60°C to obtain an extract. Starch is added at 0.5% of the mass of the extract, and then dried at 85°C. The dried product is pulverized to 60 mesh. The semi-finished product is mixed with microcrystalline cellulose and sodium carboxymethyl starch (the amount of microcrystalline cellulose added is 0.5% of the mass of the semi-finished product, and the amount of sodium carboxymethyl starch added is 0.5% of the mass of the semi-finished product). Magnesium stearate is added (the amount added is 0.5% of the mass of the semi-finished product), and then mixed uniformly. The mixture is compressed to obtain tablets.

[0051] Comparative Example 1

[0052] Comparative Example 1 provides a Chinese medicine preparation, which comprises the following raw materials by weight: 25 parts of Radix Astragali, 13 parts of Radix Notoginseng, 10 parts of Radix Linderae, 8 parts of Radix Paeoniae Rubra, 11 parts of Bulbus Allii Macrostemi, and 5 parts of Radix Glycyrrhizae. That is, Herba Prenanthes is omitted from the raw materials.

[0053] Comparative Example 1 also provides a preparation method of the Chinese medicine preparation as described above, which is consistent with that of Example 1.

[0054] Comparative Example 2

[0055] Comparative Example 2 provides a Chinese medicine preparation, which comprises the following raw materials by weight: 25 parts of Radix Astragali, 20 parts of Herba Prenanthes, 13 parts of Radix Notoginseng, 8 parts of Radix Paeoniae Rubra, 11 parts of Bulbus Allii Macrostemi, and 5 parts of Radix Glycyrrhizae. That is, Radix Linderae is omitted from the raw materials.

[0056] Comparative Example 2 also provides a preparation method of the Chinese medicine preparation as described above, which is consistent with that of Example 1.

[0057] Test Example 1

[0058] To verify the safety of the traditional Chinese medicine preparations of Examples 1-3 and Comparative Examples 1-2 of this invention, the following experiments were conducted, with the following steps: SD male rats weighing 180-200g were selected as experimental animals (SPF grade), totaling 72 rats, and randomly divided into 6 groups of 12 rats each. A cycle of 12 hours of light and 12 hours of darkness was maintained, with a housing temperature of 23±2℃ and a relative humidity of 50±5%, for one week of acclimatization. Before the experiment, each group was fasted but allowed free access to water for 12 hours. Based on the raw drug content, each group was administered 6g / kg of the traditional Chinese medicine preparations of Examples 1-3 and Comparative Examples 1-2 by gavage. One group was administered an equal volume of physiological saline by gavage (blank control group). The rats were housed separately for one month. Adverse changes in the SD rats' weight, food intake, movement, mental state, and mortality were observed, and the results are shown in Table 1.

[0059] Table 1

[0060]

[0061] The experimental results in Table 1 show that the rats' body weight did not change significantly, their appetite and exercise were good, and no abnormalities or other allergic reactions occurred. This indicates that the traditional Chinese medicine preparations of Examples 1-3 and Comparative Examples 1-2 of this invention have good biocompatibility.

[0062] Experimental Example 2

[0063] 1. Laboratory animals:

[0064] Healthy male SD rats, SPF grade, weighing 180-200g, were selected. A total of 120 rats were kept in a controlled environment at 25℃ and 55% humidity, maintaining a 12h / 12h diurnal cycle. They were provided with normal water and food throughout the experiment and underwent acclimatization for one week.

[0065] 2. Grouping of animals:

[0066] The SD rats were randomly divided into a normal control group, a model group, a positive drug group, a low-dose example 1 group, a medium-dose example 1 group, a high-dose example 1 group, a low-dose example 2 group, a low-dose example 3 group, a low-dose comparative example 1 group, and a low-dose comparative example 2 group, with 12 rats in each group. Except for the normal control group, all other groups had to undergo modeling.

[0067] 3. Constructing a rat model of coronary heart disease:

[0068] A rat model of coronary heart disease was established by feeding rats with compound vitamin D3 and isoproterenol hydrochloride on a high-fat diet for a total period of 17 weeks. The normal control group was fed a basal diet, while the other groups were fed a high-fat diet. The formula of the high-fat diet was: 15% lard, 18% sucrose, and 3% egg yolk by weight added to the basal diet. All rats had free access to food and water and were fed continuously for 17 weeks.

[0069] On the first day of modeling, rats in each group were given vitamin D3 by gavage at a dose of 600,000 units / kg, and on the 14th, 28th, 42nd, and 56th days of modeling, rats were given vitamin D3 (100,000 units / kg) by gavage. Rats in the normal control group were given the same volume of normal saline by gavage on the 1st, 14th, 28th, 42nd, and 56th days. On the last two days of the 17th week of administration, rats in the model group and each administration group were given subcutaneous injections of isopropyl epinephrine hydrochloride (85 mg / kg) at multiple points on the back, once a day.

[0070] 4. Administration method:

[0071] Gavage administration was started on the 15th week of modeling, once a day, for a total of 3 weeks;

[0072] The positive drug group was given atorvastatin calcium 2.1 mg / kg;

[0073] Low-dose Example 1 group: 1 g / kg of the traditional Chinese medicine preparation of Example 1 was given as crude drug;

[0074] Medium-dose Example 1 group: 2 g / kg of the traditional Chinese medicine preparation of Example 1 was given as crude drug;

[0075] High-dose Example 1 group: 4 g / kg of the traditional Chinese medicine preparation of Example 1 was given as crude drug;

[0076] Low-dose Example 2 group: 1 g / kg of the traditional Chinese medicine preparation of Example 2 was given as crude drug;

[0077] Low-dose Example 3 group: 1 g / kg of the traditional Chinese medicine preparation of Example 3 was given as crude drug;

[0078] Low-dose Comparative Example 1 group: 1 g / kg of the traditional Chinese medicine preparation of Comparative Example 1 was given as crude drug;

[0079] Low-dose Comparative Example 2 group: 1 g / kg of the traditional Chinese medicine preparation of Comparative Example 2 was given as crude drug;

[0080] The normal control group and the model group were given the same amount of normal saline every day.

[0081] 5. Index detection

[0082] After the last administration, the rats were fasted for 12 h without water restriction, sacrificed, and given intraperitoneal injection of 3% sodium pentobarbital at a dose of 2 mL / kg for anesthesia. Blood was collected from the abdominal aorta for standby use.

[0083] (1) Take the abdominal aorta blood of rats, centrifugal at 4000 rpm for 5 min, separate serum, adopt ELISA to determine the level of total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL-C), high density lipoprotein (HDL-C) in serum, and the test results are recorded in Table 2.

[0084] Table 2

[0085]

[0086] TC and LDL-C are the raw materials of atherosclerotic plaque formation. The reduction of TC and LDL-C helps to reduce the plaque formation and development from the source. High TG is one of the risk factors of coronary heart disease, which is related to lipid metabolism disorder, LDL increase, etc. TG reduction helps to achieve the treatment of coronary heart disease. High-density lipoprotein cholesterol is an anti-atherosclerotic lipoprotein, which can transport cholesterol from peripheral tissues to the liver for metabolism. The increase of HDL-C level helps to regulate lipid level and slow down atherosclerosis.

[0087] From the experimental results of Table 2, compared with the normal control group, the contents of TC, TG and LDL-C of the model group rats all increased, and the content of anti-arteriosclerosis factor HDL-C decreased, indicating that the rats had dyslipidemia and severe lipid metabolism disorder. Compared with the model group, the contents of TC, TG and LDL-C of the rats were significantly reduced after using the traditional Chinese medicine preparation of the application, and the content of HDL-C increased, indicating that the traditional Chinese medicine preparation of the application could regulate lipid metabolism and play a therapeutic role on atherosclerosis.

[0088] Compared with the low-dose example 1 group, the low-dose comparative example 1 group omits the Gnaphalium affine, and the low-dose comparative example 2 omits the small rosmarin, and the effects of both are not as good as that of the low-dose example 1 group.

[0089] (2) Take the above centrifuged serum, and detect the contents of IL-6 and oxidized low density lipoprotein (OX-LDL) in the serum of rats in each group by enzyme-linked immunosorbent assay (ELISA). The experimental results are shown in Table 3.

[0090] Table 3

[0091]

[0092] Oxidized low-density lipoprotein (OX-LDL) is a core component of atherosclerotic plaques. OX-LDL also induces and maintains inflammatory responses in the blood vessel walls. Therefore, lowering OX-LDL levels directly demonstrates that the drug alleviates oxidative stress damage in the body, fundamentally reducing the formation of atherosclerotic substances. Coronary artery disease (CAD) is essentially a chronic inflammatory disease. IL-6 is a key signaling molecule reflecting the inflammatory state of atherosclerosis and can affect plaque stability. Therefore, lowering IL-6 levels demonstrates the anti-inflammatory effect of the drug and inhibits inflammatory pathways in CAD.

[0093] As shown in Table 3, compared with the normal control group, the levels of IL-6 and Ox-LDL in the model group rats were significantly increased. Compared with the model group, the levels of IL-6 and Ox-LDL in the rats treated with the traditional Chinese medicine preparation of this invention showed varying degrees of decrease. Compared with the low-dose Example 1 group, the effects of the low-dose comparative example 1 and the low-dose comparative example 2 groups were relatively poor.

[0094] (3) Blood was collected from the abdominal aorta of rats, heparin was added for anticoagulation, and the shear rate was detected using a fully automated hemorheology analyzer at 5s. -1 50s -1 200s -1 Whole blood viscosity and hemorheological parameters were measured. The experimental results are shown in Table 4.

[0095] Table 4

[0096]

[0097] Various lipid indicators in rat serum can reflect blood viscosity and fluidity, and can indirectly reflect the pathological state of cardiovascular diseases such as coronary heart disease. Patients with coronary heart disease typically have blood in a hypercoagulable and hyperviscosity state, making them prone to thrombosis. Decreased whole blood viscosity indicates improved microcirculation and a reduced risk of thrombosis, which is crucial for preventing acute events such as myocardial infarction.

[0098] As shown in Table 4, compared with the normal control group, the whole blood viscosity (shear rate 5s) of the model group rats was significantly lower. -1 50s -1 200s -1 The whole blood viscosity of rats in the high-dose Examples 1-3 groups was significantly increased. Compared with the model group, the whole blood viscosity of rats in the high-dose Examples 1-3 groups was significantly reduced, while the comparative Examples 1 and 2, which changed the composition of the drugs in the formulation, had a poorer effect on reducing whole blood viscosity. The above results indicate that the traditional Chinese medicine preparation of the present invention can reduce whole blood viscosity and improve blood rheological parameters.

[0099] In summary, the traditional Chinese medicine preparation of the present application plays a therapeutic role in regulating blood lipids, anti-inflammatory, antioxidant, improving blood rheology and other aspects, realizes the effect of treating both symptoms and root causes, balances the lipid metabolism disorder of rats, realizes the therapeutic effect on atherosclerosis, and helps to realize the prevention and treatment of coronary heart disease.

[0100] Finally, it should be pointed out that the above embodiments are only used to illustrate the technical solutions of the present application, but not to limit them. The basic principles and main features of the present application have been described above with specific embodiments, and some modifications or replacements can be made on the basis of the present application, but these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the present application.

Claims

1. A traditional Chinese medicine preparation for treating coronary heart disease, characterized in that, It is composed of the following raw materials in parts by weight: Astragalus membranaceus 22-28 parts, Clematis armandii 20-25 parts, Panax notoginseng 13-18 parts, Ulmus pumila 10-15 parts, Paeonia lactiflora 8-13 parts, Allium macrostemon 7-12 parts, Glycyrrhiza uralensis 3-8 parts.

2. The traditional Chinese medicine preparation for treating coronary heart disease according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: Astragalus membranaceus 25 parts, Clematis armandii 20 parts, Panax notoginseng 13 parts, Angelica dahurica 10 parts, Paeonia lactiflora 8 parts, Allium macrostemon 11 parts, and Glycyrrhiza uralensis 5 parts.

3. The method for preparing a traditional Chinese medicine preparation for treating coronary heart disease according to claim 1 or 2, characterized in that, Includes the following steps: (1) Weigh out the following ingredients according to the weight ratio of the Chinese herbal preparation: hairy dandelion, Panax notoginseng, and small umbellatus. Soak them in water, then heat and extract them. Filter the mixture to obtain an aqueous extract. (2) Weigh out Astragalus membranaceus, Paeonia lactiflora, Allium macrostemon and Glycyrrhiza uralensis according to the weight ratio of the Chinese herbal preparation, soak them in water, then heat and extract, filter, and obtain an aqueous extract; (3) Combine the aqueous extracts obtained in steps (1) and (2), add ethanol and refrigerate, then recover the ethanol, concentrate to obtain an extract, add pharmaceutically acceptable excipients, and prepare a traditional Chinese medicine preparation.

4. The method for preparing a traditional Chinese medicine preparation for treating coronary heart disease according to claim 3, characterized in that, In step (1), the amount of water added is 8-10 times the total mass of the hairy privet, Panax notoginseng and small umbellatus.

5. The method for preparing a traditional Chinese medicine preparation for treating coronary heart disease according to claim 3, characterized in that, In step (1), the soaking time is 2-4 hours, the heating extraction temperature is 80-100°C, and the time is 1.5-3 hours; the heating extraction is performed 2-3 times.

6. The method for preparing a traditional Chinese medicine preparation for treating coronary heart disease according to claim 3, characterized in that, In step (2), the amount of water added is 8-12 times the total mass of Astragalus membranaceus, Paeonia lactiflora, Allium macrostemon and Glycyrrhiza uralensis.

7. The method for preparing a traditional Chinese medicine preparation for treating coronary heart disease according to claim 3, characterized in that, In step (2), the soaking time is 2-4 hours, the heating extraction temperature is 80-100°C, and the time is 2-3 hours; the heating extraction is performed 2-3 times.

8. The method for preparing a traditional Chinese medicine preparation for treating coronary heart disease according to claim 3, characterized in that, In step (3), ethanol is added to make the alcohol content 40-80 w / v.

9. The method for preparing a traditional Chinese medicine preparation for treating coronary heart disease according to claim 3, characterized in that, In step (3), the relative density of the extract is 1.1-1.

5.

10. The method for preparing a traditional Chinese medicine preparation for treating coronary heart disease according to claim 3, characterized in that, The dosage form of the traditional Chinese medicine preparation is any one of oral liquid, tablets, pills, granules or capsules.

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