Traditional Chinese medicine composition for treating coronary heart disease complicated with depressive state and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating coronary heart disease complicated with depressive state and application of the traditional Chinese medicine composition. Specifically, the invention provides a composition which comprises trichosanthes kirilowii maxim, allium macrostemon, salvia miltiorrhiza and blighted wheat. The composition can effectively cope with the problem that coronary heart disease patients are combined with the depressive state. The traditional Chinese medicine not only has the curative effect of treating qi stagnation and blood stasis, but also can remarkably improve the depressive symptom of a patient, so that the comprehensive treatment effect is realized.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine, in particular, to a traditional Chinese medicine composition for treating coronary heart disease combined with depression and application thereof. BACKGROUND

[0002] Coronary atherosclerotic heart disease is caused by high blood pressure, hyperlipidemia and other reasons causing coronary atherosclerosis, causing arterial lumen stenosis or occlusion, leading to myocardial ischemia and hypoxia or necrosis and causing heart disease. The clinical manifestations of coronary heart disease are sudden onset of precordial discomfort, mostly paroxysmal angina or crushing pain or choking sensation. According to the objective evidence of mental stress-induced myocardial ischemia reported by the Lancet magazine in 1984, not only do cardiovascular disease patients tend to have mental and psychological diseases, but mental and psychological diseases are also one of the independent risk factors of coronary heart disease. Therefore, coronary heart disease combined with depression are interrelated, interinfluential, and causally related, thereby forming a vicious cycle.

[0003] At present, modern medicine has limitations in preventing and treating coronary heart disease combined with depression, such as single mechanism of action of clinical drugs, which is difficult to simultaneously improve cardiovascular and regulate mental and psychological health. Traditional Chinese medicine believes that coronary heart disease combined with depression belongs to the category of "chest pain" combined with "depression" in traditional Chinese medicine, which is the result of imbalance of zang-fu yin and yang. The theory of "heart governing mental activity" in Huangdi Neijing, and "people worry and think about the heart" in Suwen Benbinglun, it can be seen that the heart is related to the spirit and emotions, and emotional imbalance is one of the important factors affecting heart disease. The core pathogenesis is qi stagnation, the liver governs the flow of qi, the liver is yin in nature and yang in function, liver yin deficiency, liver dysfunction or depression damages the liver, causing liver qi to be not comfortable, liver qi stagnation, and qi movement being not smooth, which cannot promote the normal movement of body fluid, stagnation, condensation into phlegm; liver qi stagnation, blood stasis, blood stasis, heart blood stasis, "heart governing blood vessels" dysfunction, and blood stasis, forming a vicious cycle and inducing chest pain. Clinical symptoms include chest pain, palpitation, chest distension, emotional fluctuations, sighing, depressed, crying, and purple tongue.

[0004] Traditional Chinese medicine has advantages in treating coronary heart disease combined with depression, and has accumulated rich experience. The basic principle of traditional Chinese medicine in treating coronary heart disease combined with depression is to promote blood circulation and remove blood stasis, and the present application provides a clinically effective traditional Chinese medicine composition, which can more effectively control the occurrence and development of coronary heart disease combined with depression. SUMMARY

[0005] The present application aims to at least solve one of the technical problems in the prior art. Therefore, the present application provides a traditional Chinese medicine compound preparation for promoting blood circulation and removing blood stasis, and its use in treating coronary heart disease combined with depression and improving the prognosis of coronary heart disease patients.

[0006] Therefore, in a first aspect, the present application provides a composition. According to an embodiment of the present application, the composition comprises: Gualou, Xiebai, Danshen and Tiaogan. The present application has been obtained through a large amount of creative labor, and has been clinically verified to be effective in dealing with the problem of coronary heart disease patients combined with depression. It not only has the effect of treating qi stagnation and blood stasis, but also can significantly improve the depressive symptoms of patients, thereby achieving a comprehensive treatment effect.

[0007] In a second aspect of the present application, a traditional Chinese medicine composition is provided. According to an embodiment of the present application, the traditional Chinese medicine composition comprises: the composition of the first aspect. Thus, the traditional Chinese medicine composition of the present application not only has a significant effect on coronary heart disease patients combined with depression, but also achieves a comprehensive treatment effect by treating qi stagnation and blood stasis and improving depressive symptoms. It is an innovative treatment plan that provides a more comprehensive and effective treatment option for coronary heart disease patients and is expected to have a positive impact in clinical practice.

[0008] In a third aspect of the present application, the use of the composition of the first aspect or the traditional Chinese medicine composition of the second aspect in the preparation of a medicament for treating and / or preventing and / or relieving diseases or conditions related to coronary heart disease and / or depression is provided.

[0009] Beneficial effects:

[0010] 1. The inventors, combined with their own understanding of the core pathogenesis of coronary heart disease combined with depression (heart and blood vessels blocked), provide a traditional Chinese medicine compound preparation with the effects of promoting blood circulation, removing blood stasis, resolving phlegm and relieving depression. Clinical application research has confirmed that it can be used to reduce angina symptoms and the depressive state of patients, significantly improve the clinical symptoms of patients, improve the quality of life of patients, and can be used for the treatment of coronary heart disease combined with depression, with definite and significant effects.

[0011] 2. The traditional Chinese medicine compound preparation of the present application has fewer raw medicine flavors, low cost, is easy to prepare, and is suitable for popularization and application.

[0012] 3. The traditional Chinese medicine compound preparation of the present application is made of pure traditional Chinese medicine, has no toxic side effects, and no adverse reactions or adverse events have been found in application, with good safety.

[0013] Additional aspects and advantages of the present application will be partially given in the following description, partially will become obvious from the following description, or will be understood through the practice of the present application. DETAILED DESCRIPTION

[0014] The embodiments of the present application are described in detail below. The embodiments described below are exemplary and are only used to explain the present application, and cannot be understood as a limitation of the present application.

[0015] It should be noted that the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated, nor are they in any particular order. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0016] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0017] To facilitate understanding of this invention, certain technical and scientific terms are specifically defined below. Unless otherwise expressly defined elsewhere in this invention, all other technical and scientific terms used herein have the meanings commonly understood by one of ordinary skill in the art to which this invention pertains.

[0018] In this invention, the terms "comprising" or "including" are open-ended expressions, meaning they include the contents specified in this invention but do not exclude other aspects.

[0019] In this invention, the terms “optionally,” “optionally,” or “optionally” generally refer to events or conditions described subsequently that may but may not occur, and the description includes both cases in which the event or condition occurs and cases in which the event or condition does not occur.

[0020] In this document, “prevention” and “avoidance” are used interchangeably. These terms refer to methods of obtaining beneficial or desired results, including but not limited to preventive benefits. To obtain a “preventive benefit,” the composition or a product containing it may be given to a subject at risk of developing a particular disease, or to a subject who reports one or more physiological symptoms of a disease, even if a diagnosis of the disease may not have been made.

[0021] In the present text, the terms "treatment" and "treatment" refer to the use to obtain the desired pharmacological and / or physiological effect. The effect can be prophylactic in terms of completely or partially preventing a disease or symptom thereof and / or therapeutic in terms of a partial or complete cure of a disease and / or adverse effect attributable to the disease. "Treatment" as used herein covers the treatment of a disease in a mammal, particularly in a human, and includes: (a) preventing the disease or condition from occurring in an individual which can be predisposed to the disease but has not yet developed the disease; (b) inhibiting the disease, i.e., arresting its development; or (c) relieving the disease, i.e., causing the partial or complete regression of the symptoms of the disease. "Treatment" as used herein covers any use of a drug or compound to treat, cure, alleviate, improve, relieve or inhibit a disease in an individual, including but not limited to the administration of a drug containing a compound described herein to an individual in need thereof.

[0022] The present application proposes a composition and its use, a preparation method of the composition, a traditional Chinese medicine composition and its use, which will be described in detail respectively.

[0023] Composition

[0024] In one aspect of the present application, the present application proposes a composition comprising: Gualou, Xiebai, Danshen and floating wheat. The inventors have obtained the composition through a large amount of creative labor, and the composition has been clinically verified to be able to effectively deal with the problem of coronary heart disease patients combined with depression. It not only has the effect of treating qi stagnation and blood stasis, but also can reduce the symptoms of angina pectoris in coronary heart disease patients, improve the depression of patients, improve the long-term prognosis effect and the quality of life, so as to realize the comprehensive treatment effect.

[0025] The composition of the present application is formed by carefully selecting drugs according to the traditional Chinese medicine theory on the basis of many years of clinical practice. Gualou is the monarch drug in the prescription, which is sweet, slightly bitter and cold, and can clear lung and phlegm, widen chest and disperse knots, and moisten dryness and lubricate intestines. Danshen is bitter and cold, and can activate blood and resolve stasis, dredge channels and relieve pain, clear heart and relieve distress, and cool blood and resolve abscess. Xiebai can dredge yang and disperse knots, and regulate qi and remove stagnation. Both of them are the ministerial drugs. Floating wheat is sweet and cool, and can stop virtual and night sweat, and nourish heart and relieve distress. According to the "Suwen", "wheat belongs to fire, and is the grain of heart, and floating wheat has no meat", so it can cool the heart. The combination of the above drugs aims to regulate qi and activate blood, resolve phlegm and relieve depression, and treat coronary heart disease combined with depression due to qi stagnation and blood stasis. The combination of several drugs can regulate qi and activate blood, resolve phlegm and relieve depression, which is in line with the etiology and pathogenesis of coronary heart disease combined with depression.

[0026] According to the embodiments of the present application, the composition can further include at least one of the following additional technical features:

[0027] According to the embodiment of the present application, the composition comprises: 5-45 parts by weight of Gualou; 13-120 parts by weight of Xiebai; 5-45 parts by weight of Danshen; 30-270 parts by weight of floating wheat. Thus, the composition can better play the effect, can move qi and activate blood, resolve phlegm and open depression, improve the clinical symptoms of angina pectoris and depression of patients, inhibit the development of inflammation, improve the prognosis of patients, improve the quality of life of patients, and can be used for the treatment of coronary heart disease combined with depression, and the curative effect is accurate and remarkable.

[0028] According to the embodiment of the present application, the composition comprises: 10-30 parts by weight of Gualou; 13-90 parts by weight of Xiebai; 9-30 parts by weight of Danshen; 30-120 parts by weight of floating wheat. Thus, the composition can better play the effect, can move qi and activate blood, resolve phlegm and open depression, improve the clinical symptoms of angina pectoris and depression of patients, inhibit the development of inflammation, improve the prognosis of patients, improve the quality of life of patients, and can be used for the treatment of coronary heart disease combined with depression, and the curative effect is accurate and remarkable.

[0029] According to the embodiment of the present application, the composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of floating wheat. Thus, the composition can better play the effect, can move qi and activate blood, resolve phlegm and open depression, improve the clinical symptoms of angina pectoris and depression of patients, inhibit the development of inflammation, improve the prognosis of patients, improve the quality of life of patients, and can be used for the treatment of coronary heart disease combined with depression, and the curative effect is accurate and remarkable.

[0030] According to the embodiment of the present application, the composition can further comprise: Juxiang and Sharen. Thus, the composition can move qi and activate blood, resolve phlegm and open depression, regulate qi and warm the center, and be used for the treatment of coronary heart disease combined with depression.

[0031] According to the embodiment of the present application, the composition comprises: 5-45 parts by weight of Gualou; 13-120 parts by weight of Xiebai; 5-45 parts by weight of Danshen; 30-270 parts by weight of floating wheat; 5-45 parts by weight of Juxiang; 2-18 parts by weight of Sharen. Thus, the composition can move qi and activate blood, resolve phlegm and open depression, regulate qi and warm the center, and be used for the treatment of coronary heart disease combined with depression.

[0032] According to the embodiment of the present application, the composition comprises: 10-30 parts by weight of Gualou; 13-90 parts by weight of Xiebai; 9-30 parts by weight of Danshen; 30-120 parts by weight of floating wheat; 5-45 parts by weight of Juxiang; 2-18 parts by weight of Sharen. Thus, the composition can move qi and activate blood, resolve phlegm and open depression, regulate qi and warm the center, and be used for the treatment of coronary heart disease combined with depression.

[0033] According to the embodiment of the present application, the composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of floating wheat; 5-45 parts by weight of Jiangxiang; and 2-18 parts by weight of Sharen. Thus, the composition can promote blood circulation, remove phlegm and calm the depressed, regulate qi and warm the middle, and is used for the treatment of coronary heart disease combined with depression.

[0034] According to the embodiment of the present application, the composition can further comprise Shenggancao and Dazao. The composition comprises: 5-45 parts by weight of Gualou; 13-120 parts by weight of Xiebai; 5-45 parts by weight of Danshen; 30-270 parts by weight of floating wheat; 3-30 parts by weight of Shenggancao; and 3-45 parts by weight of Dazao. Thus, the composition can promote blood circulation, remove phlegm and calm the depressed, nourish the heart and replenish qi, and calm the nerves and relieve urgency.

[0035] According to the embodiment of the present application, the composition can further comprise Shenggancao and Dazao. The composition comprises: 10-30 parts by weight of Gualou; 13-90 parts by weight of Xiebai; 9-30 parts by weight of Danshen; 30-120 parts by weight of floating wheat; 3-30 parts by weight of Shenggancao; and 3-45 parts by weight of Dazao. Thus, the composition can promote blood circulation, remove phlegm and calm the depressed, nourish the heart and replenish qi, and calm the nerves and relieve urgency.

[0036] According to the embodiment of the present application, the composition can further comprise Shenggancao and Dazao. The composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of floating wheat; 3-30 parts by weight of Shenggancao; and 3-45 parts by weight of Dazao. Thus, the composition can promote blood circulation, remove phlegm and calm the depressed, nourish the heart and replenish qi, and calm the nerves and relieve urgency.

[0037] According to the embodiment of the present application, the composition can further comprise Guizhi. The composition comprises: 5-45 parts by weight of Gualou; 13-120 parts by weight of Xiebai; 5-45 parts by weight of Danshen; 30-270 parts by weight of floating wheat; and 1-30 parts by weight of Guizhi. Thus, the composition can promote blood circulation, remove phlegm and calm the depressed, and activate yang and dredge collaterals.

[0038] According to the embodiment of the present application, the composition can further comprise Guizhi. The composition comprises: 10-30 parts by weight of Gualou; 13-90 parts by weight of Xiebai; 9-30 parts by weight of Danshen; 30-120 parts by weight of floating wheat; and 1-30 parts by weight of Guizhi. Thus, the composition can promote blood circulation, remove phlegm and calm the depressed, and activate yang and dredge collaterals.

[0039] According to an embodiment of the present application, the composition can further comprise: cassia twig. The composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of Fumi; 1-30 parts by weight of cassia twig. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and open stagnation, and activate yang and dredge collaterals.

[0040] According to an embodiment of the present application, the composition can further comprise: cassia twig. The composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of Fumi; 1-30 parts by weight of cassia twig. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and open stagnation, and activate yang and dredge collaterals.

[0041] According to an embodiment of the present application, the composition can further comprise: cassia twig. The composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of Fumi; 1-30 parts by weight of cassia twig. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and open stagnation, and activate yang and dredge collaterals.

[0042] According to an embodiment of the present application, the composition can further comprise: cassia twig. The composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of Fumi; 1-30 parts by weight of cassia twig. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and open stagnation, and activate yang and dredge collaterals.

[0043] According to an embodiment of the present application, the composition can further comprise: cassia twig. The composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of Fumi; 1-30 parts by weight of cassia twig. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and open stagnation, and activate yang and dredge collaterals.

[0044] According to an embodiment of the present application, the composition can further comprise: cassia twig. The composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of Fumi; 1-30 parts by weight of cassia twig. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and open stagnation, and activate yang and dredge collaterals.

[0045] According to the embodiment of the present application, the composition can further comprise angelica. The composition comprises 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of floating wheat; 2-36 parts by weight of angelica. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and calm the liver, and tonify blood to relieve pain.

[0046] According to the embodiment of the present application, the composition can further comprise cassia twig, rhizoma corydalis and angelica. The composition comprises 5-45 parts by weight of Gualou; 13-120 parts by weight of Xiebai; 5-45 parts by weight of Danshen; 30-270 parts by weight of floating wheat; 1-30 parts by weight of cassia twig; 1-30 parts by weight of rhizoma corydalis; 2-36 parts by weight of angelica. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and calm the liver, and tonify blood to relieve pain.

[0047] According to the embodiment of the present application, the composition can further comprise cassia twig, rhizoma corydalis and angelica. The composition comprises 10-30 parts by weight of Gualou; 13-90 parts by weight of Xiebai; 9-30 parts by weight of Danshen; 30-120 parts by weight of floating wheat; 1-30 parts by weight of cassia twig; 1-30 parts by weight of rhizoma corydalis; 2-36 parts by weight of angelica. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and calm the liver, and tonify blood to relieve pain.

[0048] According to the embodiment of the present application, the composition can further comprise cassia twig, rhizoma corydalis and angelica. The composition comprises 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of floating wheat; 1-30 parts by weight of cassia twig; 1-30 parts by weight of rhizoma corydalis; 2-36 parts by weight of angelica. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and calm the liver, and tonify blood to relieve pain.

[0049] According to the embodiment of the present application, the composition can further comprise cassia twig, rhizoma corydalis and angelica. The composition comprises 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of floating wheat; 1-30 parts by weight of cassia twig; 1-30 parts by weight of rhizoma corydalis; 2-36 parts by weight of angelica. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and calm the liver, and tonify blood to relieve pain.

[0050] According to the embodiment of the present application, the composition can further comprise: cassia twig, raw licorice and jujube. The composition comprises: 10-30 parts by weight of Gualou; 13-90 parts by weight of Xiebai; 9-30 parts by weight of Danshen; 30-120 parts by weight of floating wheat; 1-30 parts by weight of cassia twig; 3-30 parts by weight of raw licorice; and 3-45 parts by weight of jujube. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and calm the depressed, activate yang and dredge collaterals, and nourish the heart and replenish qi to calm the spirit and relieve urgency.

[0051] According to the embodiment of the present application, the composition can further comprise: cassia twig, raw licorice and jujube. The composition comprises: 10-20 parts by weight of Gualou; 30-50 parts by weight of Xiebai; 10-20 parts by weight of Danshen; 80-100 parts by weight of floating wheat; 1-30 parts by weight of cassia twig; 3-30 parts by weight of raw licorice; and 3-45 parts by weight of jujube. Thus, the composition can promote blood circulation to remove blood stasis, resolve phlegm and calm the depressed, activate yang and dredge collaterals, and nourish the heart and replenish qi to calm the spirit and relieve urgency.

[0052] Method for preparing medicine

[0053] The present application provides two methods for preparing medicine for treating and / or preventing and / or relieving the related diseases or symptoms of coronary heart disease and / or depression, which are different in the process but have the same purpose of extracting the effective components of the composition to achieve the best therapeutic effect.

[0054] In another aspect of the present application, a method for preparing medicine is provided, which comprises: subjecting Gualou, Xiebai, Danshen, floating wheat to a first decocting treatment with a first solvent to obtain the medicine. The method can efficiently and effectively extract the effective components of traditional Chinese medicine to ensure that these components can achieve the best therapeutic effect in the patient's body, thereby achieving excellent therapeutic effect.

[0055] According to the embodiment of the present application, the method can further comprise at least one of the following additional technical features:

[0056] According to the embodiment of the present application, the first solvent is selected from, but not limited to, water, glutinous rice wine or (1%-4%) alcohol solution, as long as it can extract the effective components of the medicine.

[0057] According to an embodiment of the present application, the weight ratio of Gualou, Xiebai, Danshen and Milchurpi is (5-45):(13-120):(5-45):(30-270). The inventor has found through a large number of experiments that the preparation of the medicine with the composition in the weight ratio can make the medicine have better efficacy, can promote blood circulation and remove blood stasis, resolve phlegm and relieve depression, improve the clinical symptoms of angina pectoris and depression of patients, inhibit the development of inflammation, improve the prognosis of patients, and improve the quality of life of patients, and can be used for the treatment of coronary heart disease combined with depression, has exact curative effect and remarkable effect.

[0058] According to an embodiment of the present application, the mass-volume ratio (g / mL) of Gualou and the first solvent is (5-45):(400-1300). In this way, the effective components in Gualou can be more fully decocted, thereby exerting better curative effect.

[0059] According to an embodiment of the present application, the mass-volume ratio (g / mL) of Xiebai and the first solvent is (13-120):(400-1300). In this way, the effective components in Xiebai can be more fully decocted, thereby exerting better curative effect.

[0060] According to an embodiment of the present application, the mass-volume ratio (g / mL) of Danshen and the first solvent is (5-45):(400-1300). In this way, the effective components in Danshen can be more fully decocted, thereby exerting better curative effect.

[0061] According to an embodiment of the present application, the mass-volume ratio (g / mL) of Milchurpi and the first solvent is (30-270):(400-1300). In this way, the effective components in Milchurpi can be more fully decocted, thereby exerting better curative effect.

[0062] According to an embodiment of the present application, the time of the first decocting treatment is 1-2 h. In this way, the extraction of the effective components of the medicine can be more complete, and the stability of the drug efficacy can be maintained.

[0063] In another aspect of the present application, a method for preparing a medicine is provided, which comprises: subjecting Gualou, Xiebai, Danshen, Milchurpi and optionally Guizhi, Yansuo, Dangui, Jiangxiang, Sharen, Shengancan, Dazao to a second decocting treatment with a second solvent to obtain a first supernatant and a first residue; adding the first residue into a third solvent for a third decocting treatment to obtain a second supernatant; and mixing the first supernatant and the second supernatant to obtain the composition. The method can efficiently and effectively extract the effective components in the medicine to ensure that these components exert the best drug efficacy in the patient, thereby achieving excellent therapeutic effect.

[0064] It should be noted that after the second decocting treatment, the obtained first supernatant is poured out, and then a third solvent is added into the container containing the first dregs to continue the decocting treatment (third decocting treatment), after the completion of the decocting, the supernatant (second supernatant) is poured out, mixed with the first supernatant, and filtered to obtain the composition.

[0065] According to the embodiments of the present application, the method can further include at least one of the following additional technical features:

[0066] According to the embodiments of the present application, the second solvent is selected from, but not limited to, water, glutinous rice wine or (1%~4%) alcohol solution, as long as it can decoct the effective components in the medicine.

[0067] According to the embodiments of the present application, the weight ratio of Gualou, Xiebai, Danshen and Fuxiao is (5~45):(13~120):(5~45):(30~270). The inventors have found through a large number of experiments that the medicine prepared by using the composition with the weight ratio can make the medicine better play the efficacy, can promote blood circulation and remove blood stasis, resolve phlegm and relieve depression, improve the clinical symptoms of angina pectoris and depression of patients, inhibit the development of inflammation, improve the prognosis of patients, and improve the quality of life of patients, and can be used for the treatment of coronary heart disease combined with depression, with exact curative effect and remarkable effect.

[0068] According to the embodiments of the present application, the weight ratio of Gualou, Xiebai, Danshen, Fuxiao and Guizhi is (5~45):(13~120):(5~45):(30~270):(1~30). The inventors have found through a large number of experiments that the medicine prepared by using the composition with the weight ratio can make the medicine better play the efficacy, can promote blood circulation and remove blood stasis, resolve phlegm and relieve depression, and can be used for the treatment of coronary heart disease combined with depression, with exact curative effect and remarkable effect.

[0069] According to the embodiments of the present application, the weight ratio of Gualou, Xiebai, Danshen, Fuxiao and Guizhi is (5~45):(13~120):(5~45):(30~270):(1~30). The inventors have found through a large number of experiments that the medicine prepared by using the composition with the weight ratio can make the medicine better play the efficacy, can promote blood circulation and remove blood stasis, resolve phlegm and relieve depression, and can be used for the treatment of coronary heart disease combined with depression, with exact curative effect and remarkable effect.

[0070] According to an embodiment of the present application, the weight ratio of Gualou, Xiebai, Danshen, floating wheat, and Danggui is (5-45):(13-120):(5-45):(30-270):(2-36). The inventor has found through a large number of experiments that the medicine prepared by using the composition with the weight ratio can better exert the efficacy, can activate blood and resolve stasis, can resolve phlegm and relieve depression, can dissipate blood stasis and relieve pain, can improve the clinical symptoms of angina pectoris and depression of the patient, can inhibit the development of inflammation, can improve the prognosis of the patient, and can improve the quality of life of the patient, and can be used for the treatment of coronary heart disease combined with depression, has a definite effect, and has a remarkable effect.

[0071] According to an embodiment of the present application, the weight ratio of Gualou, Xiebai, Danshen, floating wheat, Jiangxiang, and Sharen is (5-45):(13-120):(5-45):(30-270):(3-45):(1-18). The inventor has found through a large number of experiments that the medicine prepared by using the composition with the weight ratio can better exert the efficacy, can activate blood and resolve stasis, can resolve phlegm and relieve depression, can dissipate blood stasis and relieve pain, can improve the clinical symptoms of angina pectoris and depression of the patient, can inhibit the development of inflammation, can improve the prognosis of the patient, and can improve the quality of life of the patient, and can be used for the treatment of coronary heart disease combined with depression, has a definite effect, and has a remarkable effect.

[0072] According to an embodiment of the present application, the weight ratio of Gualou, Xiebai, Danshen, floating wheat, Guizhi, Danggui, and Yuhuosuo is (5-45):(13-120):(5-45):(30-270):(1-30):(2-36):(1-30). The inventor has found through a large number of experiments that the medicine prepared by using the composition with the weight ratio can better exert the efficacy, can activate blood and resolve stasis, can resolve phlegm and relieve depression, can dissipate blood stasis and relieve pain, can improve the clinical symptoms of angina pectoris and depression of the patient, can inhibit the development of inflammation, can improve the prognosis of the patient, and can improve the quality of life of the patient, and can be used for the treatment of coronary heart disease combined with depression, has a definite effect, and has a remarkable effect.

[0073] According to an embodiment of the present application, the weight ratio of Gualou, Xiebai, Danshen, floating wheat, Shenggancao, Dazao, and Guizhi is (5-45):(13-120):(5-45):(30-270):(3-30):(3-45):(1-30). The inventor has found through a large number of experiments that the medicine prepared by using the composition with the weight ratio can better exert the efficacy, can activate blood and resolve stasis, can resolve phlegm and relieve depression, can dissipate blood stasis and relieve pain, can improve the clinical symptoms of angina pectoris and depression of the patient, can inhibit the development of inflammation, can improve the prognosis of the patient, and can improve the quality of life of the patient, and can be used for the treatment of coronary heart disease combined with depression, has a definite effect, and has a remarkable effect.

[0074] According to an embodiment of the present application, the weight ratio of Gualou, Xiebai, Danshen, Fuximai, Shenganci and Dazao is (5-45):(13-120):(5-45):(30-270):(3-30):(3-45). The inventor has found through a large number of experiments that the medicine prepared by using the composition with the weight ratio can better exert the efficacy, can promote blood circulation and remove blood stasis, can resolve phlegm and relieve depression, can dissipate blood stasis and relieve pain, can improve the clinical symptoms of angina pectoris and depression of the patient, can inhibit the development of inflammation, can improve the prognosis of the patient, and can improve the quality of life of the patient, and can be used for the treatment of coronary heart disease combined with depression, has definite efficacy and remarkable effect.

[0075] According to an embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of Gualou to the second solvent is (5-45):(300-500). In this way, the effective components in Gualou can be more fully decocted, thereby exerting better efficacy.

[0076] According to an embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of Xiebai to the second solvent is (13-120):(300-500). In this way, the effective components in Xiebai can be more fully decocted, thereby exerting better efficacy.

[0077] According to an embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of Danshen to the second solvent is (5-45):(300-500). In this way, the effective components in Danshen can be more fully decocted, thereby exerting better efficacy.

[0078] According to an embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of Fuximai to the second solvent is (30-270):(300-500). In this way, the effective components in Fuximai can be more fully decocted, thereby exerting better efficacy.

[0079] According to an embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of Dangui to the second solvent is 2-36):(300-500). In this way, the effective components in Dangui can be more fully decocted, thereby exerting better efficacy.

[0080] According to an embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of Jiangxiang to the second solvent is (3-45):(300-500). In this way, the effective components in Jiangxiang can be more fully decocted, thereby exerting better efficacy.

[0081] According to the embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of the sand ginger to the second solvent is (1-18):(300-500). Thus, the effective components in the sand ginger can be more fully decocted, thereby exerting better curative effect.

[0082] According to the embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of the cassia twig to the second solvent is (1-30):(300-500). Thus, the effective components in the cassia twig can be more fully decocted, thereby exerting better curative effect.

[0083] According to the embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of the corydalis to the second solvent is (1-30):(300-500). Thus, the effective components in the corydalis can be more fully decocted, thereby exerting better curative effect.

[0084] According to the embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of the raw licorice to the second solvent is (3-30):(300-500). Thus, the effective components in the raw licorice can be more fully decocted, thereby exerting better curative effect.

[0085] According to the embodiment of the present application, when the second solvent is selected from water or glutinous rice wine, the mass-volume ratio (g / mL) of the jujube to the second solvent is (3-45):(300-500). Thus, the effective components in the jujube can be more fully decocted, thereby exerting better curative effect.

[0086] According to the embodiment of the present application, when the second solvent is selected from (1%-4%) alcohol solution, the mass-volume ratio (g / mL) of the trichosanthes to the second solvent is (5-45):(700-900). Thus, the effective components in the trichosanthes can be more fully decocted, thereby exerting better curative effect.

[0087] According to the embodiment of the present application, when the second solvent is selected from (1%-4%) alcohol solution, the mass-volume ratio (g / mL) of the allium to the second solvent is (13-120):(700-900). Thus, the effective components in the allium can be more fully decocted, thereby exerting better curative effect.

[0088] According to the embodiment of the present application, when the second solvent is selected from (1%-4%) alcohol solution, the mass-volume ratio (g / mL) of the salvia miltiorrhiza to the second solvent is (5-45):(700-900). Thus, the effective components in the salvia miltiorrhiza can be more fully decocted, thereby exerting better curative effect.

[0089] According to the embodiment of the present application, when the second solvent is selected from the (1%~4%) alcohol solution, the mass-volume ratio (g / mL) of the second solvent to the wheat is (30~270):(700~900). Thus, the effective components in the wheat can be more fully decocted, thereby exerting a better curative effect.

[0090] According to the embodiment of the present application, when the second solvent is selected from the (1%~4%) alcohol solution, the mass-volume ratio (g / mL) of the second solvent to the wheat is (30~270):(700~900). Thus, the effective components in the wheat can be more fully decocted, thereby exerting a better curative effect.

[0091] According to the embodiment of the present application, when the second solvent is selected from the (1%~4%) alcohol solution, the mass-volume ratio (g / mL) of the second solvent to the wheat is (30~270):(700~900). Thus, the effective components in the wheat can be more fully decocted, thereby exerting a better curative effect.

[0092] According to the embodiment of the present application, the third solvent is selected from water or glutinous rice wine.

[0093] According to the embodiment of the present application, the volume ratio of the second solvent to the third solvent is 1:(0.1~1.5).

[0094] According to the embodiment of the present application, the time of the second decocting treatment is 20~60 min. Thus, the extraction of the effective components of the medicine can be more complete, and the stability of the curative effect can be maintained.

[0095] According to the embodiment of the present application, the time of the third decocting treatment is 20~40 min. Thus, the extraction of the effective components of the medicine can be more complete, and the stability of the curative effect can be maintained.

[0096] Traditional Chinese medicine composition

[0097] In still another aspect of the present application, the present application provides a traditional Chinese medicine composition, which comprises the composition described above. Thus, the traditional Chinese medicine composition of the present application not only has a significant curative effect on the coronary heart disease patients combined with depression, but also realizes a comprehensive treatment effect by treating qi stagnation and blood stasis and improving the symptoms of depression. It is an innovative treatment scheme, which provides a more comprehensive and effective treatment option for the coronary heart disease patients, and is expected to produce a positive impact in clinical practice.

[0098] According to the embodiment of the present application, the traditional Chinese medicine composition can further comprise at least one of the following additional technical features:

[0099] According to embodiments of the present application, the traditional Chinese medicine composition can further comprise a pharmaceutically acceptable carrier or excipient.

[0100] In the present context, "pharmaceutically acceptable" means that the substance or composition must be compatible chemically and / or toxicologically, with the other ingredients of the formulation and / or the mammal being treated with it.

[0101] In the present context, the term "pharmaceutically acceptable carrier" includes any solvent, pharmaceutical stabilizer, or combinations thereof, which are known to those skilled in the art. Except where any conventional carrier is incompatible with the active ingredient, its use in the treatment or pharmaceutical composition is contemplated.

[0102] In the present context, the term "pharmaceutically acceptable excipient" can include any solvent, suitable for the particular dosage form of interest. Except where any conventional excipient is incompatible with the composition of the present disclosure, for example, to the extent that any adverse biological effects are produced or interactions with any other component of the pharmaceutically acceptable composition are produced in a deleterious manner, their use is contemplated by the present disclosure.

[0103] According to embodiments of the present application, the traditional Chinese medicine composition is an oral preparation.

[0104] According to embodiments of the present application, the oral preparation is at least one selected from the group consisting of capsules, tablets, pills, granules, decoctions, powders, dripping pills, syrups, and oral liquids, but is not limited thereto.

[0105] Use

[0106] In yet another aspect of the present application, the present application proposes the use of the aforementioned composition or the aforementioned traditional Chinese medicine composition in the preparation of a medicament for the treatment and / or prevention and / or alleviation of a disease or a condition of the related disease or condition of coronary heart disease and / or depressive state.

[0107] According to embodiments of the present application, the medicament is for the treatment and / or prevention and / or alleviation of coronary heart disease combined with depressive state.

[0108] Embodiments of the present application are described in detail below. The embodiments described below are exemplary only, and are not to be construed as limiting the present application. Unless otherwise defined, technical or scientific terms used in the embodiments have the same meaning as commonly understood by one of ordinary skill in the art. Unless otherwise indicated, the techniques or conditions employed in the embodiments are those that are conventionally used by those of ordinary skill in the art. Unless otherwise indicated, the reagents or instruments used in the embodiments are commercially available conventional products.

[0109] Example 1: Different preparation methods of traditional Chinese medicine decoction

[0110] (1) Method 1

[0111] Gualou 15g, Xiebai 40g, Danshen 15g, Fuximai 90g, add 400ml water to the above pieces of traditional Chinese medicine, soak for 30 minutes, then decoct the soaked mixture. Boil with a large fire, then decoct with a small fire for 30 minutes to 1 hour, pour out 200ml of the supernatant, add 400ml of water, boil with a large fire, then decoct with a small fire for 30 minutes, pour out 200ml of the supernatant. Combine the two supernatants about 400ml, and it is ready.

[0112] (2) Method 2

[0113] Gualou 15g, Xiebai 40g, Danshen 15g, Fuximai 90g, add 800ml water to the above pieces of traditional Chinese medicine, soak for 30 minutes, then decoct the soaked mixture. Boil with a large fire, then decoct with a small fire for 1-2 hours, pour out 400ml of the supernatant, and it is ready.

[0114] (3) Method 3

[0115] Gualou 15g, Xiebai 40g, Danshen 15g, Fuximai 90g, mix Gualou and Xiebai, then soak in 800ml water with 20ml-40ml of 45-75% food-grade alcohol for 30 minutes, then decoct the mixture with Danshen and Fuximai. Boil with a large fire, then decoct with a small fire for 20 minutes to 1 hour, pour out 200ml of the supernatant, add 500ml of water, boil with a large fire, then decoct with a small fire for 30 minutes, pour out 200ml of the supernatant. Combine the two supernatants about 400ml, and it is ready.

[0116] (4) Method 4

[0117] Gualou 15g, Xiebai 40g, Danshen 15g, Fuximai 90g, mix Gualou and Xiebai, then soak in 800ml water with 20ml-40ml of 45-75% food-grade alcohol for 30 minutes, then decoct the mixture with Danshen and Fuximai. Boil with a large fire, then decoct with a small fire for 1-2 hours, pour out 400ml of the supernatant, and it is ready.

[0118] (5) Method 5

[0119] Gualou 15g, Xiebai 40g, Danshen 15g, Fuximai 90g, mix Gualou and Xiebai, then soak in 400ml glutinous rice wine for 30 minutes, then decoct the mixture with Danshen and Fuximai. Boil with a large fire, then decoct with a small fire for 20 minutes to 1 hour, pour out 200ml of the supernatant, add 200-500ml of glutinous rice wine, boil with a large fire, then decoct with a small fire for 30 minutes, pour out 200ml of the supernatant. Combine the two supernatants about 400ml, and it is ready.

[0120] (6) Method 6

[0121] Take Gualou 15 parts by weight, 40 parts by weight of Xiebai, 15 parts by weight of Danshen, 90 parts by weight of floating wheat, 10 parts by weight of cassia, add 800 ml of water, add 45-75% edible alcohol 20 mL-40 mL, soak for 30 minutes, medium fire 1 hour, pour out the supernatant, add 100 ml of water, medium fire 40 minutes, pour out the supernatant. Combine the two supernatants, and it is ready.

[0122] (7) Method 7

[0123] Take Gualou 15 parts by weight, 40 parts by weight of Xiebai, 15 parts by weight of Danshen, 90 parts by weight of floating wheat, 10 parts by weight of cassia, add 800 ml of water, add 45-75% edible alcohol 20 mL-40 mL, soak for 30 minutes, medium fire 1 hour, pour out the supernatant, add 100 ml of water, medium fire 40 minutes, pour out the supernatant. Combine the two supernatants, and it is ready.

[0124] (8) Method 8

[0125] Gualou 15g, Xiebai 40g, Danshen 15g, floating wheat 90g, 12g of Angelica, add 400ml water to the above traditional Chinese medicine decoction pieces, soak for 30 minutes, and then decoct the soaked mixture. Boil with a large fire, and then decoct with a small fire for 30 minutes to 1 hour. Pour out 200ml of supernatant, add 400ml of water, boil with a large fire, and then decoct with a small fire for 30 minutes. Pour out 200ml of supernatant. Combine the two supernatants about 400ml, and it is ready.

[0126] (9) Method 9

[0127] Gualou 15g, Xiebai 40g, Danshen 15g, floating wheat 90g, 15g of Jinqiancao, 6g of Amomum villosum, mix Gualou and Xiebai, soak in 400ml glutinous rice wine for 30 minutes, then decoct the soaked mixture with Danshen, floating wheat, Jinqiancao and Amomum villosum. Boil with a large fire, and then decoct with a small fire for 20 minutes to 1 hour. Pour out 200ml of supernatant, add 200-500ml of glutinous rice wine, boil with a large fire, and then decoct with a small fire for 30 minutes. Pour out 200ml of supernatant. Combine the two supernatants about 400ml, and it is ready.

[0128] (10) Method 10

[0129] Gualou 15g, Xiebai 40g, Danshen 15g, floating wheat 90g, 10g of cassia, 12g of Angelica, 10g of Corydalis, mix Gualou and Xiebai, soak in 400ml glutinous rice wine for 30 minutes, then decoct the soaked mixture with Danshen, floating wheat, cassia, Angelica and Corydalis. Boil with a large fire, and then decoct with a small fire for 20 minutes to 1 hour. Pour out 200ml of supernatant, add 200-500ml of glutinous rice wine, boil with a large fire, and then decoct with a small fire for 30 minutes. Pour out 200ml of supernatant. Combine the two supernatants about 400ml, and it is ready.

[0130] (11) Method 11

[0131] Gualou 15g, Xiebai 40g, Danshen 15g, Fuximai 90g, Shenggancao 10g, Dazao 15g, Guizhi 10g, add 400ml water, soak for 30 minutes, then decoct the soaked mixture. Boil with high heat, then decoct with low heat for 30 minutes to 1 hour. Pour out 200ml of the supernatant, add 400ml of water, boil with high heat, then decoct with low heat for 30 minutes. Pour out 200ml of the supernatant. Combine the two supernatants, about 400ml, and it is ready.

[0132] (12) Method 12

[0133] Gualou 15g, Xiebai 40g, Danshen 15g, Fuximai 90g, Shenggancao 10g, Dazao 15g, Guizhi 10g, add 400ml water, soak for 30 minutes, then decoct the soaked mixture. Boil with high heat, then decoct with low heat for 30 minutes to 1 hour. Pour out 200ml of the supernatant, add 400ml of water, boil with high heat, then decoct with low heat for 30 minutes. Pour out 200ml of the supernatant. Combine the two supernatants, about 400ml, and it is ready.

[0134] Example 2: Preparation of Chinese medicine tablets

[0135] The raw medicinal herbs are Gualou 15g, Xiebai 40g, Danshen 15g, and Fuximai 90g. Add 800ml of water and decoct for 2 hours. Filter the decoction. Extract the medicinal herb residues for the second time by adding 400ml of water and decocting for 1 hour. Filter the decoction. Discard the medicinal herb residues. Combine the two filtrates. Reduce the pressure and concentrate the filtrate to a ratio of the volume of the medicinal liquid (L) to the weight of the medicinal herbs (Kg) of 1:(0.9-1.1). Add 20ml-40ml of 45-75% edible alcohol. Mix well. Allow to stand and filter. Recover the alcohol from the filtrate. Concentrate the filtrate to obtain an extract with a relative density of 1.32-1.40 (55°C). Dry. Make into granules. Press into tablets. Or coat with sugar. And it is ready.

[0136] Example 3: Preparation of Chinese medicine granules

[0137] The raw medicinal herbs are Gualou 15g, Xiebai 40g, Danshen 15g, and Fuximai 90g. Add 800ml of water and decoct for 2 hours. Filter the decoction. Extract the medicinal herb residues for the second time by adding 400ml of water and decocting for 50 minutes. Add 2g of Sharen and 5g of Jiangxiang and decoct for 10 minutes. Filter the decoction. Discard the medicinal herb residues. Combine the two filtrates. Reduce the pressure and concentrate the filtrate to a ratio of the volume of the medicinal liquid (L) to the weight of the medicinal herbs (Kg) of 1:(0.9-1.1). Add 20ml-40ml of 45-75% edible alcohol. Mix well. Allow to stand and filter. Recover the alcohol from the filtrate. Concentrate the filtrate to obtain an extract with a relative density of 1.32-1.40 (55°C). Take the extract. Add an appropriate amount of dextrin. Granulate. And it is ready.

[0138] Example 4: Preparation of Chinese medicine pills

[0139] The raw materials Gualou 15g, Xiebai 40g, Danshen 15g, Fuximai 90g, and the excipients sucrose ester 15g and glycerin monostearate 4g were put into an extraction tank, 5 times the amount of water was added, 45-75% of edible alcohol 20-40ml was added, and decoction was performed for 2 hours. The filtrate was obtained by filtration, and the filter residue was subjected to a second extraction. 4 times the amount of water was added, decoction was performed for 1 hour, and the filtrate was obtained by filtration. The filter residue was discarded, and the filtrates were combined. The filtrate was subjected to ultrafiltration using a polyether sulfone membrane with a molecular weight cut-off of 50000. The ultrafiltrate was concentrated to obtain an extract with a relative density of 1.35-1.39 (55°C). The operating conditions of the ultrafiltration process were as follows: the inlet pressure of the ultrafiltration was 0.33Mpa, and the outlet pressure of the ultrafiltration was 0.180kPa lower than the inlet pressure. A lower pressure was used initially, and then the pressure was gradually increased. Periodic pressure fluctuations were used during the ultrafiltration process, with a pressure fluctuation difference of 0.2Mpa. The flow rate of the feed liquid was 2.5m / s. Periodic flow fluctuations were used during the ultrafiltration process to generate pulsatile flow or unstable flow in the membrane channels, with a flow fluctuation difference of 2.0m / s. Nitrogen was intermittently introduced into the ultrafiltration system to form a gas-liquid pulsatile flow, with a cycle of 1.5h of aeration once every 1 minute. The temperature of the feed liquid was 45°C. When the feed liquid was concentrated by 1 / 8, water was added for ultrafiltration for 2 more times. The pH value of the feed liquid was controlled at 7.5.

[0140] The extract was mixed with the excipients sucrose ester and glycerin monostearate, heated to a temperature of 60°C, and the material was melted for 30 minutes. The melted material was then transferred to a dropping tank of a drop pill machine with a tank temperature of 90°C. The liquid was dropped into 6°C liquid paraffin, and the drop pills were taken out, deoiled, and sieved to obtain the pills.

[0141] Example 5: Preparation of Chinese medicine decocted extract

[0142] Gualou 15 parts by weight, Xiebai 40 parts by weight, Danshen 15 parts by weight, Fuximai 90 parts by weight, and Dazao 15 parts by weight were added to a refluxing apparatus, and heated to reflux for 2 hours. The refluxing liquid was stored in a separate container. The residue was decocted with water for 3 times, each time for 1 hour. The ethanol content was adjusted to 65% by adding edible alcohol. After standing for 24 hours, the filtrate was obtained by filtration. The filtrate was combined with the above-mentioned refluxing liquid. The ethanol was recovered by vacuum distillation, and the filtrate was concentrated to a thick extract with a relative density of 1.10-1.20 at 55°C. Thus, a decocted extract for treating coronary heart disease combined with depression was obtained.

[0143] Example 6: Preparation of Chinese medicine drop pills

[0144] Take medicinal material raw material to take Gualou 15 parts by weight, Xiebai 40 parts by weight, Danshen 15 parts by weight, and Fuximai 90 parts by weight, add water to reflux extraction twice, combine the extract, concentrate, add ethanol to precipitate, filter, concentrate to recover ethanol, and obtain medicinal material extract; mix the extract with excipient polyethylene glycol uniformly, heat the material, and the weight ratio of the extract to the excipient is 1:2; move the extract mixed with excipient into the dropping tank of the drop pill machine, drop into low-temperature liquid paraffin, remove the liquid paraffin, select the pills, and obtain the drop pill oral preparation for treating coronary heart disease combined with depressive state.

[0145] Example 7: Clinical cases of traditional Chinese medicine composition for coronary heart disease combined with depressive state

[0146] Case 1

[0147] Jia, male, 55 years old, initial diagnosis date: August 22, 2023. Complaint: recurrent chest tightness with low mood for more than 6 years. Present illness: The patient had intermittent chest tightness for 6 years, with precordial discomfort, which worsened after exercise, lasting for several minutes to ten minutes. He had low mood and was prone to sadness and tears. In August 2017, the patient experienced chest compression, shortness of breath after swimming, and the degree of discomfort was more severe than before. He took “quick-acting heart-saving pills” with no effect. He was admitted to a tertiary hospital, where coronary CTA+chest CT showed coronary atherosclerotic changes with multiple different degrees of stenosis, including right coronary artery and left anterior descending branch near segment local severe stenosis. CAG+PCI was performed, and intraoperative findings showed LAD middle segment stenosis about 90%, distal about 70-80% stenosis, LCX opening near segment about 70% stenosis, distal slender about 90-95% stenosis, RCA near segment about 30% stenosis, middle segment about 90% stenosis, and PLA distal about 90% stenosis. Three stents were implanted: one in RCA, two in LAD. The TCM syndrome efficacy score was 13 points. The patient was diagnosed with “coronary atherosclerotic heart disease” and “depressive state.” After treatment with aspirin, ticagrelor, and atorvastatin calcium tablets, the patient's symptoms stabilized and he was discharged. Since then, the patient has experienced recurrent chest tightness, shortness of breath, and fatigue, which is induced by exercise. He has no interest in things, is easily tearful, has a dull expression, and is reluctant to communicate with others or go out and socialize. His sleep quality is poor.

[0148] Current symptoms: recurrent chest tightness, shortness of breath, no chest pain, fatigue, aversion to cold, no interest in things, easily sad and tearful, dull expression, reluctant to communicate with others, reluctant to go out and socialize. Poor appetite, poor sleep, 1 bowel movement per day, dry, and 0 nocturia.

[0149] Physical examination: medium body type, yellowish complexion, dark tongue, thin yellow fur, and slippery pulse.

[0150] Diagnosis: chest pain and depression

[0151] Treatment: Gualou Xiebai Banxia Decoction combined with Ganmai Dazao Decoction with modifications.

[0152] Trichosanthes 15g, Radix Bletillae 40g, Salvia miltiorrhiza 15g, Triticum repen 90g

[0153] Radix Glycyrrhizae 14g, Fructus Jujubae 30g

[0154] 14 doses, water decoction, 1 dose per day, add 20ml high concentration of liquor to decoct with medicine. 200ml of warm decoction is taken half an hour after breakfast and dinner.

[0155] September 12, 2023 (second visit): The patient complained of chest tightness after taking 21 doses of medicine, occasional swelling, less fatigue, improved mood, and willingness to communicate with others. The tongue was pale red, the fur was thin and yellow, and the pulse was stringy. Because the patient's symptoms were relieved, the neck and back were easy to sweat. The prescription was mainly based on Gualou Xiebai Banxia Decoction, with 12g of Ramulus Cinnamomi and 12g of Angelica sinensis. 21 doses were used to consolidate the curative effect. The symptoms and tongue and pulse changes were adjusted.

[0156] October 17, 2023 (third visit): The patient complained of chest tightness after taking 28 doses of medicine, breathing smoothly, feeling strong, and significantly improving nervousness, no frustration, and willingness to go out and socialize. The tongue was pale, the fur was thin and white, and the pulse was stringy. Because the patient's symptoms were relieved, the curative effect was consolidated.

[0157] December 19, 2023 (fourth visit): The patient complained of no chest tightness and shortness of breath, and significantly improved nervousness and no frustration. The TCM syndrome efficacy score was 3 points. The curative effect was consolidated.

[0158] Example 8: Small sample clinical control experiment of traditional Chinese medicine composition on coronary heart disease combined with depression

[0159] (1) Case data

[0160] All patients were from the cardiovascular department of Guang'anmen Hospital of China Academy of Chinese Medical Sciences from December 2022 to February 2024, and met the criteria for coronary heart disease combined with depression, a total of 31 cases. Using random number table method, 15 cases were divided into control group and 16 cases were divided into treatment group.

[0161] (2) Treatment method

[0162] The control group of patients applied conventional treatment of coronary heart disease western medicine (including anti-platelet drugs, statins, etc.), and the treatment group orally took the decoction prepared in the above-mentioned example 1 of the application on the basis of conventional treatment. The prescription: Trichosanthes 15g, Radix Bletillae 40g, Salvia miltiorrhiza 15g, Triticum repen 90g, all of which were provided by the Chinese medicine pharmacy of China Academy of Chinese Medical Sciences. Water decoction, 1 dose per day, 200ml was taken half an hour after breakfast and dinner, twice a day. The curative effect was evaluated after 8 weeks of treatment.

[0163] (3) Evaluation index of curative effect

[0164] The evaluation standard of TCM syndrome efficacy score is based on the Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine (Trial). The efficacy is determined as follows: significant effect, primary and secondary symptoms are basically or completely disappeared, and the syndrome score is reduced by ≥70% after treatment; effective, the syndrome score is reduced by ≥30% after treatment; ineffective, the syndrome score is reduced by less than 30% after treatment; and aggravation, the score is increased after treatment.

[0165] (4) Statistical analysis

[0166] Both groups of data were analyzed by SPSS 26.0 software. The measurement data were expressed as mean ± standard deviation; t-test was used for comparison between groups and within groups; the number (n) and percentage (%) were used for count data, and χ 2 test was used for comparison between groups.

[0167] (5) Results analysis

[0168] The results are shown in Table 1 and Table 2. Compared with before treatment, the TCM syndrome efficacy score table score after treatment was significantly lower than that before treatment (P<0.01); there was a statistically significant difference between the control group and the treatment group (P<0.05).

[0169] Table 1 TCM syndrome efficacy score table

[0170]

[0171] Table 2 TCM syndrome efficacy evaluation table

[0172]

[0173] (6) Conclusion

[0174] After 8 weeks of treatment, the TCM syndrome score was significantly lower than that before treatment, and there was a statistically significant difference between the control group and the treatment group after treatment. It is indicated that on the basis of conventional western medicine treatment of coronary heart disease, combined with Gualou Xiebai Banxia Decoction and Ganmai Dazao Decoction can significantly improve the symptoms of coronary heart disease and depression state, and improve the quality of life of patients, providing a safe and effective new approach for the clinical treatment of patients with coronary heart disease combined with depression.

[0175] In the description of the specification, the description of the terms "one embodiment", "some embodiments", "an example", "a specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are contained in at least one embodiment or example of the present application. In the specification, the illustrative description of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any suitable manner in any one or more embodiments or examples. In addition, the person skilled in the art can combine and combine the different embodiments or examples described in the specification and the features of the different embodiments or examples without contradiction.

[0176] Although the embodiments of the present application have been shown and described above, it is understood that the above-described embodiments are exemplary and are not to be construed as limiting the present application, and those skilled in the art can make changes, modifications, replacements and variations to the above-described embodiments within the scope of the present application.

Claims

1. A composition characterized in that, comprising: Trichosanthes, Chinese onion, Salvia miltiorrhiza and Triticum repens.

2. The composition of claim 1, wherein, The composition comprises: 5-45 parts by weight of Trichosanthes; 13-120 parts by weight of Chinese onion; 5-45 parts by weight of Salvia miltiorrhiza; 30-270 parts by weight of Triticum repens.

3. The composition of claim 1, wherein, The composition comprises: 10-30 parts by weight of Trichosanthes; 13-90 parts by weight of Chinese onion; 9-30 parts by weight of Salvia miltiorrhiza; 30-120 parts by weight of Triticum repens.

4. The composition of claim 1, wherein, The composition comprises: 10-20 parts by weight of Trichosanthes; 30-50 parts by weight of Chinese onion; 10-20 parts by weight of Salvia miltiorrhiza; 80-100 parts by weight of Triticum repens.

5. The composition according to any one of claims 1 to 4, characterized in that, further comprising: Lignum and Amomum; optionally, further comprising: 3-45 parts by weight of Lignum; 1-18 parts by weight of Amomum.

6. The composition according to any one of claims 1 to 4, characterized in that, further comprising: at least one of raw licorice, jujube, cassia twig, Corydalis and Angelica; optionally, further comprising: 3-30 parts by weight of raw licorice; 3-45 parts by weight of jujube; optionally, further comprising: 1-30 parts by weight of cassia twig; optionally, further comprising: 1-30 parts by weight of Corydalis; optionally, further comprising: 2-36 parts by weight of Angelica; optionally, further comprising: 1-30 parts by weight of cassia twig; 1-30 parts by weight of Corydalis; 2-36 parts by weight of Angelica; optionally, further comprising: 1-30 parts by weight of cassia twig; 3-30 parts by weight of raw licorice; 3-45 parts by weight of jujube.

7. A traditional Chinese medicine composition, characterized in that, comprising the composition of any one of claims 1-6.

8. The traditional Chinese medicine composition according to claim 7, characterized in that, further comprising a pharmaceutically acceptable carrier or excipient.

9. The traditional Chinese medicine composition according to claim 7 or 8, characterized in that, The traditional Chinese medicine composition is an oral preparation; optionally, the oral preparation is selected from at least one of a capsule, a tablet, a pill, a granule, a decoction, a powder, a dripping pill, a syrup and an oral liquid.

10. Use of the composition of any one of claims 1-6 or the traditional Chinese medicine composition of any one of claims 7-9 in the preparation of a medicament for treating and / or preventing and / or relieving a disease or condition related to coronary heart disease and / or depression; optionally, the medicament is for treating and / or preventing and / or relieving coronary heart disease combined with depression.

Images