A traditional Chinese medicine composition for treating coronary heart disease combined with depression and anxiety and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating coronary heart disease combined with depression and anxiety and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines, wherein components and weights of the traditional Chinese medicine composition are as follows: Danshen powder 5-35g, Zishen 6-35g, Cijili 6-30g, Huangqi 15-50g, Zhigancao 6-30g, Zhizi 5-35g and Xiangchi 4-35g. The above scheme of the application takes Danshen to enter the heart to dredge collaterals and activate blood circulation, takes Huangqi to tonify qi to treat the root, takes Zishen and Cijili to remove blood stasis and dredge collaterals, takes Zhizi to clear heat and relieve restlessness, takes Douchi to remove evil and relieve heat, and takes Zhigancao to harmonize the center and tonify qi, so that the whole prescription can achieve the functions of activating blood circulation, dredging collaterals, clearing heat and relieving restlessness.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition and preparation method for treating coronary heart disease complicated with depression and anxiety. Background Technology

[0002] There are two theories regarding the co-occurrence of coronary heart disease and depression: one is the theory of shared etiology, and the other is the theory of emotional factors causing the disease. Under the influence of the same etiology, if the pathogenesis of the two diseases is consistent, then the two diseases may coexist in the same individual. One of the reasons for the co-occurrence of coronary heart disease and depression is that they share a common etiology—emotional imbalance. Emotional factors play an important role in the pathogenesis of coronary heart disease and depression.

[0003] The theory that coronary heart disease and depression are accompanied by qi and blood stagnation is relevant, as both chest pain and depression share similarities in terms of stagnation and obstruction, and their underlying pathogenesis is consistent. Furthermore, the co-occurrence of coronary heart disease and depression is also related to constitutional similarity, exhibiting a theory of yin excess and yang deficiency. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention proposes a traditional Chinese medicine composition and its preparation method for treating coronary heart disease complicated with depression and anxiety.

[0005] To achieve the above objectives, the present invention provides a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety. The components and weights of the traditional Chinese medicine composition are as follows: 5-35g of Salvia miltiorrhiza powder, 6-35g of Salvia miltiorrhiza, 6-30g of Tribulus terrestris, 15-50g of Astragalus membranaceus, 6-30g of Glycyrrhiza uralensis (processed), 5-35g of Gardenia jasminoides, and 4-35g of fermented soybean.

[0006] Preferably, the components and weights of the traditional Chinese medicine composition are as follows: 30g of Salvia miltiorrhiza powder, 30g of Salvia miltiorrhiza, 30g of Tribulus terrestris, 46g of Astragalus membranaceus, 27g of prepared Glycyrrhiza uralensis, 30g of Gardenia jasminoides, and 15g of fermented soybean.

[0007] Preferably, the components and weights of the traditional Chinese medicine composition are as follows: 8g of Salvia miltiorrhiza powder, 17g of Salvia miltiorrhiza, 13g of Tribulus terrestris, 32g of Astragalus membranaceus, 26g of prepared Glycyrrhiza uralensis, 19g of Gardenia jasminoides, and 6g of fermented soybean.

[0008] Preferably, the components and weights of the traditional Chinese medicine composition are as follows: 16g of Salvia miltiorrhiza powder, 24g of Salvia miltiorrhiza, 23g of Tribulus terrestris, 29g of Astragalus membranaceus, 18g of prepared licorice root, 11g of Gardenia jasminoides, and 8g of fermented soybean.

[0009] Preferably, the components and weights of the traditional Chinese medicine composition are as follows: 22g of Salvia miltiorrhiza powder, 26g of Salvia miltiorrhiza, 28g of Tribulus terrestris, 17g of Astragalus membranaceus, 11g of prepared Glycyrrhiza uralensis, 14g of Gardenia jasminoides, and 32g of fermented soybean.

[0010] Another aspect of the present invention provides a method for preparing a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety, comprising the following steps:

[0011] S1. Weigh the Chinese herbal medicine composition according to the weight proportions;

[0012] S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C.

[0013] S3. Add powder C to three times its volume of water and boil for 20-30 minutes. Then add powder B and stir well. Add two times its volume of 40-80% ethanol and soak for 15-60 minutes. Then add powder A and five times its volume of water and boil for 30 minutes to obtain the product.

[0014] Another aspect of the present invention provides the application of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety in the preparation of a drug for treating qi deficiency, blood stasis, and liver stagnation syndrome.

[0015] Another aspect of the present invention provides the application of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety in the preparation of a drug for treating coronary heart disease complicated with anxiety and depression.

[0016] Compared with existing technologies, this invention provides a traditional Chinese medicine composition and preparation method for treating coronary heart disease complicated with depression and anxiety. The core pathogenesis of coronary heart disease complicated with anxiety and depression is mainly qi stagnation, blood stasis, and deficiency of vital energy. Emotional and blood stasis both originate from the heart, and blood stasis is closely related to emotional abnormalities such as anxiety and depression, as well as coronary heart disease. The treatment principle is "activating blood circulation and unblocking collaterals, clearing the heart and relieving irritability". This formula uses Danshen (Salvia miltiorrhiza) to enter the heart, unblock collaterals, activate blood circulation and remove blood stasis. It has pharmacological effects such as anticoagulation, antithrombosis, improving microcirculation, improving blood rheology, anti-myocardial ischemia, anti-inflammation, and lowering cholesterol. Huangqi (Astragalus membranaceus) is a qi-tonifying herb. Replenishing qi treats the root cause, and when qi is vigorous, blood flows smoothly. It has the effects of enhancing the body's immune function, anti-oxidation, and improving microcirculation. Zishen (Purple Ginseng) and Cijili (Tribulus terrestris) remove blood stasis and unblock collaterals, which can improve cardiac function, dilate coronary arteries, and nourish the myocardium and enhance cardiac function. Zhizi (Gardenia jasminoides) clears heat and relieves irritability, Douchi (Fermented soybean) dispels pathogens and relieves fever, and Zhigancao (Glycyrrhiza uralensis) harmonizes the middle and benefits qi. Gardenia, with its bitter and cold properties, clears heat and relieves irritability, exhibiting both descending and dispersing effects; fermented soybean, with its clear and cold nature, ascends and disperses, regulating the middle jiao, exhibiting both dispersing and descending effects. The combination of these two herbs works synergistically to clear heat and relieve irritability. Based on this, Danshen Decoction combined with Gardenia and Fermented Soybean Decoction can achieve the therapeutic effects of "activating blood circulation, clearing heat, and relieving irritability." Furthermore, research has confirmed that many traditional Chinese medicine decoctions, prepared medicines, and active ingredients with blood-activating and stasis-removing effects possess a "dual-heart" therapeutic effect on both the heart and mind, providing a basis for clinical application. Detailed Implementation

[0017] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0018] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Every smaller range between any stated value or intermediate value within a stated range, and any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0019] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0020] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be readily apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0021] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0022] In this invention, the active pharmaceutical ingredient can be produced using any commonly used pulverizing method and equipment in the field. Pulverizing methods include, but are not limited to, dry pulverization, wet pulverization, and cryogenic pulverization. Pulverizing equipment includes, but is not limited to, pulverizers, ball mills, colloid mills, such as hammer mills, Shibata pulverizers, multi-functional pulverizers, vertical sieve pulverizers, and universal pulverizers.

[0023] The traditional Chinese medicine composition of the present invention can be a traditional Chinese medicine extract, a pharmaceutical preparation, or a health product preparation.

[0024] The traditional Chinese medicine composition of the present invention can be tablets, capsules, granules, pills, micro-pills, powders, mixtures, soft capsules, drop pills, or ointments, preferably tablets, capsules, granules, or pills, and more preferably tablets, capsules, or pills.

[0025] The traditional Chinese medicine composition of the present invention can be prepared into a suitable dosage form by adding any excipients used in the art. The excipients include, but are not limited to, disintegrants, fillers, lubricants, wetting agents, solubilizers, co-solvents, emulsifiers, colorants, binders, osmotic pressure modifiers, regulators, stabilizers, flow aids, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesion agents, antioxidants, antioxidant synergists, chelating agents, penetration enhancers, pH adjusters, plasticizers, surfactants, foaming agents, defoamers, thickeners, inclusion agents, humectants, absorbents, diluents, flocculants and anti-flocculation agents, filter aids, etc.

[0026] The medicinal effects of each traditional Chinese medicine in this invention are as follows:

[0027] Salvia miltiorrhiza, bitter and slightly cold in nature, has the effects of promoting blood circulation and relieving pain, cooling blood and reducing swelling, promoting blood circulation and removing blood stasis, and clearing the mind and relieving irritability. When used as medicine, it can also reduce blood viscosity, effectively prevent thrombosis, thereby improving the function of the cardiovascular system and playing a role in calming the nerves and relieving pain.

[0028] Purple ginseng has a bitter and astringent taste and is slightly cold in nature. It has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding, and reducing swelling and dissipating nodules. It has the effect of improving blood circulation. Its components, such as tanshinone and tanshinone acid, can promote blood circulation, increase the blood flow rate in the microcirculation, improve vascular permeability, reduce platelet aggregation, and reduce blood viscosity.

[0029] Tribulus terrestris has a bitter and pungent taste. It can regulate liver qi, relieve emotional depression, promote blood circulation, dispel wind-evil, improve eyesight, and relieve itching. Furthermore, it has cardiotonic and anti-arteriosclerotic effects, reduces platelet aggregation, lowers blood sugar, has anti-allergic, antihypertensive, and diuretic effects.

[0030] Astragalus, with its mild medicinal properties, has the effects of tonifying qi, strengthening the exterior, promoting diuresis, and astringing sores. Pharmacological studies have shown that astragalus can enhance immune function, promote diuresis, resist aging, protect the liver, and lower blood pressure. In addition, astragalus can regulate blood sugar levels, protect the cardiovascular system, and play a role in the recovery of the body from radiation damage.

[0031] Prepared licorice root is sweet and neutral in nature, and enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying qi and strengthening the middle jiao, moistening the lungs and relieving cough, clearing heat and detoxifying, relieving spasms and pain, and harmonizing the properties of other herbs. It is mainly used to treat spleen deficiency and fatigue, and heart palpitations.

[0032] Gardenia, with its bitter and cold properties, enters the heart, lung, and triple burner meridians. It has the effects of purging fire and relieving irritability, clearing heat and promoting diuresis, cooling blood and detoxifying. This herb can be used to treat feverish irritability. Its bitter and cold nature allows it to descend slowly, clearing heat from the heart, lungs, and triple burner. Furthermore, raw gardenia can promote urination; for those with heat-related deficiency fire, it can clear heat and relieve irritability, allowing heart fire to be released through urination. It can treat high fever and irritability, as well as damp-heat jaundice, for which there are classic prescriptions. Moreover, because it can promote urination and clear heat...

[0033] Fermented soybeans contain a variety of active ingredients such as isoflavones, polypeptides, oligosaccharides, soybean fibrinolytic enzymes, a large amount of B vitamins and antibiotics, which have a good effect on the prevention and control of cardiovascular diseases, diabetes, osteoporosis, breast cancer and menopausal syndrome in women.

[0034] Example 1

[0035] A traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety, the components and weights of the traditional Chinese medicine composition are as follows: 30g of Salvia miltiorrhiza powder, 30g of Salvia miltiorrhiza, 30g of Tribulus terrestris, 46g of Astragalus membranaceus, 27g of prepared licorice root, 30g of Gardenia jasminoides, and 15g of fermented soybean.

[0036] The preparation method of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety includes the following steps:

[0037] S1. Weigh the Chinese herbal medicine composition according to the weight proportions;

[0038] S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C.

[0039] S3. Add powder C to three times its volume of water and boil for 25 minutes. Then add powder B and stir well. Add two times its volume of 50% ethanol and soak for 30 minutes. Then add powder A and five times its volume of water and boil for 30 minutes to obtain the product.

[0040] Example 2

[0041] A traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety, the components and weights of the traditional Chinese medicine composition are as follows: 8g of Salvia miltiorrhiza powder, 17g of Salvia miltiorrhiza, 13g of Tribulus terrestris, 32g of Astragalus membranaceus, 26g of prepared licorice root, 19g of Gardenia jasminoides, and 6g of fermented soybean.

[0042] The preparation method of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety includes the following steps:

[0043] S1. Weigh the Chinese herbal medicine composition according to the weight proportions;

[0044] S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C.

[0045] S3. Add powder C to three times its volume of water and boil for 25 minutes. Then add powder B and stir well. Add two times its volume of 50% ethanol and soak for 30 minutes. Then add powder A and five times its volume of water and boil for 30 minutes to obtain the product.

[0046] Example 3

[0047] A traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety, the components and weights of the traditional Chinese medicine composition are as follows: 16g of Salvia miltiorrhiza powder, 24g of Salvia miltiorrhiza, 23g of Tribulus terrestris, 29g of Astragalus membranaceus, 18g of prepared licorice root, 11g of Gardenia jasminoides, and 8g of fermented soybean.

[0048] The preparation method of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety includes the following steps:

[0049] S1. Weigh the Chinese herbal medicine composition according to the weight proportions;

[0050] S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C.

[0051] S3. Add powder C to three times its volume of water and boil for 25 minutes. Then add powder B and stir well. Add two times its volume of 50% ethanol and soak for 30 minutes. Then add powder A and five times its volume of water and boil for 30 minutes to obtain the product.

[0052] Example 4

[0053] A traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety, the components and weights of the traditional Chinese medicine composition are as follows: 22g of Salvia miltiorrhiza powder, 26g of Salvia miltiorrhiza, 28g of Tribulus terrestris, 17g of Astragalus membranaceus, 11g of prepared licorice root, 14g of Gardenia jasminoides, and 32g of fermented soybean.

[0054] The preparation method of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety includes the following steps:

[0055] S1. Weigh the Chinese herbal medicine composition according to the weight proportions;

[0056] S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C.

[0057] S3. Add powder C to three times its volume of water and boil for 25 minutes. Then add powder B and stir well. Add two times its volume of 50% ethanol and soak for 30 minutes. Then add powder A and five times its volume of water and boil for 30 minutes to obtain the product.

[0058] Example 5

[0059] A traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety, the components and weights of the traditional Chinese medicine composition are as follows: 30g of Salvia miltiorrhiza powder, 35g of Salvia miltiorrhiza, 30g of Tribulus terrestris, 25g of Astragalus membranaceus, 15g of prepared licorice root, 15g of Gardenia jasminoides, and 6g of fermented soybean.

[0060] The preparation method of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety includes the following steps:

[0061] S1. Weigh the Chinese herbal medicine composition according to the weight proportions;

[0062] S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C.

[0063] S3. Add powder C to three times its volume of water and boil for 25 minutes. Then add powder B and stir well. Add two times its volume of 50% ethanol and soak for 30 minutes. Then add powder A and five times its volume of water and boil for 30 minutes to obtain the product.

[0064] Comparative Example 1

[0065] The components and weights of the traditional Chinese medicine composition are as follows: 30g of Salvia miltiorrhiza powder, 30g of Salvia miltiorrhiza, 30g of Tribulus terrestris, 25g of Astragalus membranaceus, and 10g of prepared licorice root.

[0066] The preparation method of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety includes the following steps:

[0067] S1. Weigh the Chinese herbal medicine composition according to the weight proportions;

[0068] S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C.

[0069] S3. Add powder C to three times its volume of water and boil for 25 minutes. Then add powder B and stir well. Add two times its volume of 50% ethanol and soak for 30 minutes. Then add powder A and five times its volume of water and boil for 30 minutes to obtain the product.

[0070] Comparative Example 2

[0071] The components and weights of the traditional Chinese medicine composition are as follows: 30g of Salvia miltiorrhiza powder, 30g of Salvia miltiorrhiza, 30g of Tribulus terrestris, 25g of Astragalus membranaceus, 10g of prepared Glycyrrhiza uralensis, 10g of Gardenia jasminoides, and 10g of fermented soybean.

[0072] The preparation method of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety includes the following steps:

[0073] S1. Weigh the Chinese herbal medicine composition according to the weight proportions;

[0074] S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C.

[0075] S3. Add powders A, B, and C to eight times their volume of water and boil for 1 hour.

[0076] When extracting the traditional Chinese medicine composition of this invention, preferably, Salvia miltiorrhiza, Tribulus terrestris, Astragalus membranaceus, prepared licorice root, and Gardenia jasminoides are first extracted with water, wherein the extraction methods include, but are not limited to, water decoction extraction and water reflux extraction. After water extraction, an ethanol solution is added for alcohol extraction. The alcohol extraction methods can also be ethanol percolation extraction and ethanol solution reflux extraction, wherein the ethanol solution is a 40-80% ethanol solution, preferably a 40-50% ethanol solution.

[0077] This invention allows for the extraction of Salvia miltiorrhiza, Tribulus terrestris, Astragalus membranaceus, prepared licorice root, and Gardenia jasminoides individually, or by mixing two or more herbs for extraction. In one embodiment of this invention, Salvia miltiorrhiza is extracted alone with ethanol, preferably by warm soaking in 50% ethanol for 25 minutes.

[0078] The present invention relates to the application of a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety in the preparation of a drug for treating qi deficiency, blood stasis, and liver stagnation syndrome. Preferably, it is used in the preparation of a drug for treating coronary heart disease complicated with anxiety and depression.

[0079] Test

[0080] Forty-five patients diagnosed with coronary heart disease and anxiety / depression in the outpatient department were randomly divided into three groups of 15 each: an experimental group, a control group 1, and a control group 2. The experimental group received the drug prepared in Example 5, control group 1 received the drug prepared in Comparative Example 1, and control group 2 received the drug prepared in Comparative Example 2. The medication was administered twice daily, 200 mL each time. All indicators were remeasured and tested after 12 weeks of treatment.

[0081] Inclusion criteria: Patients diagnosed with coronary heart disease and angina pectoris through coronary angiography, color Doppler ultrasound, and electrocardiogram, with significantly elevated levels of IL-6 and TNF-α in venous blood. Furthermore, those with a total score >40 on the Zung Self-Assessment Scale for Anxiety (SAS) and the Zung Self-Assessment Scale for Depression (SDS) were diagnosed with coronary heart disease complicated by anxiety and depression.

[0082] (1) Zung Anxiety Scale (SAS)

[0083] Anxiety disorder and its severity are determined by a rating scale (total score / 80). A score below 0.5 indicates no anxiety; 0.5–0.59 indicates mild anxiety; 0.6–0.69 indicates moderate to severe anxiety; and >0.7 indicates severe anxiety.

[0084] After treatment, those with a total Zung scale score <40 were considered cured; those with a total score >40 but a decrease of >10 points were considered effective; and those with a decrease of <10 points were considered ineffective.

[0085] (2) Zung Self-Assessment Scale for Depression (SDS)

[0086] Depression and its severity are determined using a rating scale (total score / 80). A score below 0.5 indicates no depression; 0.5–0.59 indicates mild depression; 0.6–0.69 indicates moderate to severe depression; and >0.7 indicates severe depression.

[0087] After treatment, those with a total Zung scale score <40 were considered cured; those with a total score >40 but a decrease of >10 points were considered effective; and those with a decrease of <10 points were considered ineffective.

[0088] (3) Characteristic judgment

[0089] Significant effect: Clinical signs are significantly improved, major symptoms such as angina pectoris disappear or reach the criteria for significant effect, and the electrocardiogram returns to normal or reaches a roughly normal level.

[0090] Effective: Clinical signs all improved, major symptoms such as angina pectoris were reduced or reached the effective standard, and electrocardiogram showed improvement to the effective standard.

[0091] Ineffective: Clinical signs show no significant improvement or even worsen; major symptoms such as angina pectoris do not improve or worsen; electrocardiogram is basically the same as before treatment or even worsens.

[0092] (4) Blood rheology detection of inflammatory factor indicators

[0093] In the formation of coronary atherosclerosis, endothelial dysfunction, inflammatory response, and oxidative stress interact and form a vicious cycle. Among these, inflammation is the primary culprit in the transformation of plaques from a stable state to a vulnerable state, and even plaque rupture leading to thrombosis and ultimately acute cardiovascular events. The therapeutic effect of the herbal composition of this invention on coronary heart disease was verified by detecting TNF-α and IL-6 levels before and after treatment.

[0094] Patients underwent fasting venous blood collection one day prior to drug administration, along with 5 ml of venous blood. The collected blood samples were centrifuged and stored at -80°C for the detection of IL-6 and TNF-α. ELISA was used for the detection. After 3 months of treatment, blood samples were collected again to assess efficacy indicators.

[0095] Statistical methods: SPSS 17 was used for analysis.

[0096] After 12 weeks of continuous drug administration, the above indicators of the patients were measured and tested again, as follows:

[0097] Table 1 Zung Anxiety Disorder Self-Assessment Scale

[0098]

[0099] Table 2 Zung Depression Self-Assessment Scale

[0100]

[0101] Table 3 Characteristic Judgment

[0102]

[0103] Table 4 Inflammatory Factor Detection Table

[0104]

[0105] Statistical analysis showed no statistically significant differences in any indicators, inflammatory factors TNF-α, and IL-6 before and after treatment, indicating that the control group and the experimental group were at the same baseline level before treatment and were comparable.

[0106] After 12 weeks of treatment, as shown in Tables 1-4, the experimental group exhibited significantly better treatment outcomes compared to control groups 1 and 2, demonstrating a marked alleviating effect on depression. Furthermore, the herbal composition of this invention significantly inhibited the relatively high expression of the inflammatory factor IL-6 in the inflammatory response, while its inhibitory effect on the key factor TNF-α was lower than that on IL-6.

[0107] The herbal composition of this invention alleviates the symptoms of coronary heart disease, relieves the suffering caused by depression, and improves the quality of life. The value of this herbal composition lies in its ability to invigorate blood circulation, clear heat, and relieve irritability, thereby improving the symptoms of patients with coronary heart disease and concurrent depression while simultaneously enhancing overall individual function, aiming to achieve dual regulation of both physiological and psychological aspects.

[0108] In summary, the traditional Chinese medicine composition of the present invention can effectively treat coronary heart disease and depression. The overall traditional Chinese medicine composition has the effects of promoting blood circulation, clearing heat and relieving irritability.

[0109] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5-35g of Salvia miltiorrhiza powder, 6-35g of Codonopsis pilosula, 6-30g of Tribulus terrestris, 15-50g of Astragalus membranaceus, 6-30g of Glycyrrhiza uralensis (processed), 5-35g of Gardenia jasminoides, and 4-35g of fermented soybean.

2. The traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety according to claim 1, characterized in that, The components and weights of the traditional Chinese medicine composition are as follows: 30g of Salvia miltiorrhiza powder, 30g of Salvia miltiorrhiza, 30g of Tribulus terrestris, 46g of Astragalus membranaceus, 27g of prepared licorice root, 30g of Gardenia jasminoides, and 15g of fermented soybean.

3. The traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety according to claim 1, characterized in that, The components and weights of the traditional Chinese medicine composition are as follows: 8g of Salvia miltiorrhiza powder, 17g of Salvia miltiorrhiza, 13g of Tribulus terrestris, 32g of Astragalus membranaceus, 26g of prepared Glycyrrhiza uralensis, 19g of Gardenia jasminoides, and 6g of fermented soybean.

4. The traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety according to claim 1, characterized in that, The components and weights of the traditional Chinese medicine composition are as follows: 16g of Salvia miltiorrhiza powder, 24g of Salvia miltiorrhiza, 23g of Tribulus terrestris, 29g of Astragalus membranaceus, 18g of prepared licorice root, 11g of Gardenia jasminoides, and 8g of fermented soybean.

5. A traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety according to claim 1, characterized in that, The components and weights of the traditional Chinese medicine composition are as follows: 22g of Salvia miltiorrhiza powder, 26g of Salvia miltiorrhiza, 28g of Tribulus terrestris, 17g of Astragalus membranaceus, 11g of Glycyrrhiza uralensis (processed), 14g of Gardenia jasminoides, and 32g of fermented soybean.

6. A method for preparing a traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety as described in any one of claims 1-5, characterized in that, The steps are as follows: S1. Weigh the Chinese herbal medicine composition according to the weight proportions; S2. Grind fermented soybean into powder, pass through a 300-mesh sieve to obtain powder A; grind purple ginseng into powder, pass through a 150-mesh sieve to obtain powder B; weigh the remaining Chinese herbal medicine composition from step S1, mix them, grind them into powder, pass through a 150-mesh sieve to obtain powder C. S3. Add powder C to three times its volume of water and boil for 20-30 minutes. Then add powder B and stir well. Add two times its volume of 40-80% ethanol and soak for 15-60 minutes. Then add powder A and five times its volume of water and boil for 30 minutes to obtain the product.

7. The preparation method according to claim 6, characterized in that: In step S3, add powder C to three times its volume of water and boil for 25 minutes, then add powder B and stir well.

8. The preparation method according to claim 6, characterized in that: In step S3, the ethanol concentration is 50%.

9. A traditional Chinese medicine composition for treating coronary heart disease complicated with depression and anxiety as described in any one of claims 1-5, characterized in that: Application in the preparation of drugs for treating coronary heart disease complicated with anxiety and depression.

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