Traditional Chinese medicine composition for treating thoracic obstruction phlegm-qi stagnation type cardiovascular disease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating thoracic obstruction phlegm-qi stagnation type cardiovascular diseases and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from fructus trichosanthis, rhizoma pinelliae preparata, arisaema cum bile, fructus aurantii, cortex magnoliae officinalis, pericarpium citri reticulatae, poria cocos and honey-fried licorice root. The traditional Chinese medicine composition disclosed by the invention has the effects of tonifying qi and relieving chest stuffiness and arthralgia, is mainly used for treating chest stuffiness and pains and phlegm-qi stagnation type cardiovascular diseases, and is particularly suitable for patients suffering from coronary heart disease and angina pectoris. Besides, on the basis of a traditional medical formula, a modern preparation process is utilized and deeply optimized, and a dynamic decoction process and a one-step granulation technology are adopted, so that the preparation method has the advantages of simple and convenient preparation process, high efficiency, energy conservation, less damage to effective components and the like.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating cardiovascular diseases of chest impediment and phlegm and qi obstruction, and a preparation method and application thereof. BACKGROUND

[0002] Cardiovascular diseases generally refer to medical conditions affecting the structure or function of the heart, such as coronary artery disease, heart attack, angina pectoris, arrhythmia or irregular heartbeat, heart failure, heart valve disease, congenital heart disease, myocardial disease, pericardial disease, aortic disease and Marfan syndrome, and other vascular diseases. In recent years, coronary heart disease and angina pectoris are one of the most common cardiovascular diseases, which seriously threaten the health and life of human beings, especially the middle-aged and elderly population. At present, there are various limitations in the treatment of coronary heart disease and angina pectoris. Western medicines mainly include nitrate ester compounds, beta blockers and calcium antagonists, etc. However, these drugs can only relieve symptoms and have certain toxic and side effects. In addition to western medicines, traditional Chinese medicines and natural products have attracted much attention in the process of searching for new drugs.

[0003] Traditional Chinese medicine refers to coronary heart disease and angina pectoris as "chest impediment and heart pain", which is mainly manifested in clinical practice as chest pain, palpitation and shortness of breath, and even bone-penetrating chest pain. If not treated in time, it can lead to myocardial infarction and even sudden death. Traditional Chinese medicine believes that the etiology and pathology of coronary heart disease and angina pectoris are "chest impediment and heart pain, and phlegm and qi obstruction".

[0004] At present, there are many Chinese patent medicines and traditional Chinese medicine prescriptions for treating coronary heart disease and angina pectoris in clinical practice, such as Tongxinluo Capsules, Compound Danshen Tablets, Shuxiong Granules, Xuefuzhuyu Granules, Shuhuixiang Pills, Niuhuang Qingxin Pills and Shensong Yangxin Capsules, etc. However, most of them have defects such as unsatisfactory treatment effect and slow effect. In addition, although the traditional Chinese medicine decoction can be individually adjusted according to the actual situation of the patient, the traditional Chinese medicine decoction is heavy in taste and large in weight, and may also stimulate the gastrointestinal tract, and is inconvenient to carry, resulting in poor patient medication compliance, so that the patient is difficult to insist on long-term use.

[0005] Therefore, the present application develops a traditional Chinese medicine composition and a Chinese patent medicine preparation method for effectively treating cardiovascular diseases of chest impediment and phlegm and qi obstruction by means of modern pharmacological research methods and in-depth research and screening of classical famous prescriptions for treating cardiovascular diseases of chest impediment and phlegm and qi obstruction in traditional Chinese medicine. SUMMARY

[0006] In order to solve the above technical problems, the present application provides a traditional Chinese medicine composition and application thereof which can effectively treat cardiovascular diseases of chest impediment and phlegm and qi obstruction.

[0007] Specifically, the present application is realized through the following technical solutions:

[0008] In the first aspect, the present application provides a traditional Chinese medicine composition for treating cardiovascular disease of phlegm and qi obstruction type, which is prepared from the following raw materials in parts by weight: Perilla frutescens (L.) Britt. 5-50 parts, Pinellia ternata (Thunb.) Breit. 1-40 parts, Arisaema cum bils 1-40 parts, Citrus aurantium 1-40 parts, Magnolia officinalis 1-40 parts, Citrus reticulata 1-40 parts, Poria cocos 1-20 parts, and Glycyrrhiza uralensis 1-20 parts.

[0009] As an optional mode, in the above traditional Chinese medicine composition, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Perilla frutescens (L.) Britt. 10-40 parts, Pinellia ternata (Thunb.) Breit. 5-20 parts, Arisaema cum bils 5-20 parts, Citrus aurantium 5-20 parts, Magnolia officinalis 5-20 parts, Citrus reticulata 5-20 parts, Poria cocos 1-15 parts, and Glycyrrhiza uralensis 1-10 parts.

[0010] As an optional mode, in the above traditional Chinese medicine composition, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Perilla frutescens (L.) Britt. 27 parts, Pinellia ternata (Thunb.) Breit. 12 parts, Arisaema cum bils 12 parts, Citrus aurantium 12 parts, Magnolia officinalis 12 parts, Citrus reticulata 12 parts, Poria cocos 9 parts, and Glycyrrhiza uralensis 6 parts.

[0011] In the second aspect, the present application provides a preparation method of the traditional Chinese medicine composition of the first aspect, which comprises the following steps:

[0012] (1) mixing Arisaema cum bils, Magnolia officinalis, and Citrus reticulata to prepare mixed ultrafine powder;

[0013] (2) decocting Perilla frutescens (L.) Britt., Pinellia ternata (Thunb.) Breit., Citrus aurantium, and Poria cocos with water, filtering the first filtrate after the first decoction for 1-4 hours, adding water to the filter residue to decoct for 1-4 hours again, filtering the second filtrate, and combining the first filtrate and the second filtrate to prepare concentrated liquid;

[0014] (3) spraying the mixed ultrafine powder prepared in step (1) into the concentrated liquid prepared in step (2) as a base material, granulating in one step, and mixing uniformly to prepare the traditional Chinese medicine composition granules.

[0015] As an optional mode, in the above preparation method, in step (1), the fineness of the ultrafine powder is 100 mesh.

[0016] As an optional mode, in the above preparation method, in step (2), the time for the first decoction and the second decoction is 1.5 hours.

[0017] In the third aspect, the present application provides the use of the traditional Chinese medicine composition of the first aspect or the traditional Chinese medicine composition prepared by the preparation method of the second aspect in the preparation of a drug for treating cardiovascular disease of phlegm and qi obstruction type.

[0018] As an optional mode, in the above application, the cardiovascular disease is coronary heart disease, angina pectoris or myocardial infarction.

[0019] As an optional mode, in the above application, the dosage form of the drug is granules, tablets, oral liquid or capsules.

[0020] As an optional mode, in the above application, the dosage form of the drug is granules.

[0021] Compared with the prior art, the present application has the following beneficial effects:

[0022] The traditional Chinese medicine composition has the effects of tonifying qi, relieving chest and removing obstruction, and is mainly used for treating chest pain, phlegm and qi obstruction type cardiovascular disease, and is particularly suitable for coronary heart disease and angina pectoris with the above symptoms. In addition, on the basis of the traditional medicine prescription, the present application utilizes modern preparation technology and is deeply optimized, adopts dynamic decoction process and one-step granulation technology, and the preparation method has the advantages of simple and efficient preparation process, energy saving, less damage to active ingredients, etc. DETAILED DESCRIPTION

[0023] The effects and indications of each medicinal ingredient in the traditional Chinese medicine composition are as follows:

[0024] As used herein, "Gualou" is the mature fruit of Trichosanthes kirilowii Maxim. of Cucurbitaceae. It is cold in nature and sweet and slightly bitter in taste. It can clear heat and phlegm, relieve chest and resolve stasis, moisten dryness and lubricate intestines. It belongs to the category of heat phlegm clearing drugs of phlegm relieving and cough suppressing drugs. It is used to treat lung heat cough, turbid phlegm, chest pain, chest obstruction, breast abscess, lung abscess, intestinal abscess, constipation, etc. It has the functions of anti-hypoxia, anti-myocardial ischemia, anti-arrhythmia and anti-platelet aggregation.

[0025] As used herein, "Banxia" is the dried tuber of Pinellia ternata (Thunb.) Breit of Araceae. It is pungent, warm and toxic. It belongs to the spleen, stomach and lung meridians. It can dry dampness, resolve phlegm, descend adverse qi and stop vomiting, and disperse stasis. It is used for treating excessive phlegm, cough and asthma, dizziness with phlegm, dizziness with wind phlegm, headache with phlegm, vomiting and stomach upset, chest and stomach obstruction, and plum-pit syndrome. Fresh Banxia is used externally to treat abscess and phlegm.

[0026] As used herein, "Dannanxing" is made of fine powder of prepared Pinellia and bile of cattle, sheep or pigs, or made of fine powder of raw Pinellia and bile of cattle, sheep or pigs after fermentation. It is bitter and slightly pungent, and is cold in nature. It belongs to the lung, liver and spleen meridians. It can clear heat and resolve phlegm, and calm wind and suppress convulsions. It is used for treating phlegm-heat cough, yellow and thick phlegm, wind-phlegm dizziness, and epilepsy.

[0027] As used herein, "Citrus aurantium L." is the immature fruit of Rutaceae Citrus aurantium L. and its cultivated varieties. Bitter, pungent, sour, slightly cold. It belongs to the spleen and stomach meridians. It has the effect of regulating qi and unblocking the middle, and can also be used to treat chest and diaphragm qi stagnation, fullness and pain, food retention, phlegm retention, and organ prolapse.

[0028] As used herein, "Magnolia officinalis Rehd. et Wils." is the dried bark, root bark and branch bark of Magnolia officinalis Rehd. et Wils. or Magnolia offinalis Rehd. et Wils. var. biloba Rehd. et Wils. of Magnoliaceae Magnolia. Magnolia officinalis Rehd. et Wils. is bitter and pungent, warm, and belongs to the spleen, stomach, lung and large intestine meridians. It has the effects of drying dampness and reducing phlegm, and can also be used to treat dampness in the middle, abdominal distension, food retention and qi stagnation, abdominal distension and constipation, lung qi not descending, phlegm retention and cough, dampness and turbidity, cholera and diarrhea, and Meiniqi caused by emotional depression and phlegm and qi obstruction.

[0029] As used herein, "Citrus reticulata Blanco" is the dried mature pericarp of Citrus reticulata Blanco and its cultivated varieties of Rutaceae. It is bitter and pungent, warm, and belongs to the lung and spleen meridians. It has the effects of regulating qi and invigorating the spleen, and can also be used to treat abdominal distension, food retention, vomiting and diarrhea, and cough with excessive phlegm.

[0030] As used herein, "Poria cocos (Schw.) Wolf" is the dried sclerotium of Poria cocos (Schw.) Wolf of the Polyporaceae family. It is sweet and bland, and belongs to the heart, lung, spleen and kidney meridians. It has the effects of promoting water and dampness, invigorating the spleen and calming the heart. It is used for edema, urine retention, dizziness and palpitation, spleen deficiency, food retention, diarrhea, heart and mind instability, and insomnia and palpitation.

[0031] As used herein, "Glycyrrhiza uralensis Fisch." is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the Leguminosae family. It is sweet and flat, and belongs to the heart, lung and spleen meridians. It has the effects of tonifying qi and invigorating the center, moistening the lungs and relieving cough, clearing heat and detoxifying, relieving acute and relieving pain, and regulating the properties of drugs. It is mainly used for spleen deficiency, heart palpitations, cough and asthma, carbuncles and pharyngitis, drug and food poisoning, and abdominal and limb pain.

[0032] The present application will be further described below with reference to specific examples. It should be understood that the specific examples described herein are only used to explain the present application, and are not used to limit the scope of the present application.

[0033] Unless otherwise specified, the specific techniques or conditions in the examples are carried out according to the techniques or conditions described in the literature in the field, or according to the product instructions. Unless otherwise specified, the reagents or instruments used are conventional products that can be purchased through regular channels.

[0034] Unless otherwise specified, the experimental methods in the following examples are conventional methods. Unless otherwise specified, the test materials used in the following examples are commercially available products.

[0035] Preparation Example:

[0036] Example 1

[0037] A traditional Chinese medicine composition for treating cardiovascular diseases of the type of chest pain caused by obstruction of phlegm and qi, which is prepared from the following raw materials in parts by weight: whole Gualou 27 parts, clear Banxia 12 parts, Dannaixing 12 parts, Zhike 12 parts, Houpu 12 parts, Chenpi 12 parts, Fuling 9 parts, and Zhigancao 6 parts.

[0038] The preparation method of the traditional Chinese medicine composition comprises the following steps:

[0039] (1) Mix Dannaixing, Houpu, and Chenpi, and ultra-micro-pulverize to obtain a mixed ultra-micro powder, wherein the fineness of the ultra-micro powder is 100 mesh;

[0040] (2) Boil whole Gualou, clear Banxia, Zhike, Fuling, and Zhigancao in water, filter the first filtrate after boiling for 1.5 hours, add water to the filter residue and boil for another 1.5 hours, filter the second filtrate, combine the first filtrate and the second filtrate, and concentrate to obtain a concentrated solution;

[0041] (3) Use the mixed ultra-micro powder prepared in step (1) as the base material, spray into the concentrated solution prepared in step (2), granulate in one step, mix well, and obtain the traditional Chinese medicine composition granules.

[0042] Example 2

[0043] A traditional Chinese medicine composition for treating cardiovascular diseases of the type of chest pain caused by obstruction of phlegm and qi, which is prepared from the following raw materials in parts by weight: whole Gualou 20 parts, clear Banxia 10 parts, Dannaixing 19 parts, Zhike 12 parts, Houpu 14 parts, Chenpi 12 parts, Fuling 9 parts, and Zhigancao 6 parts.

[0044] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0045] Comparative Example 1

[0046] A traditional Chinese medicine composition, which is prepared from the following raw materials in parts by weight: whole Gualou 39 parts, clear Banxia 12 parts, Zhike 12 parts, Houpu 12 parts, Chenpi 12 parts, Fuling 9 parts, and Zhigancao 6 parts.

[0047] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0048] Comparative Example 2:

[0049] A traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: Gualou 27 parts, Qingbanxia 12 parts, Danshanxing 12 parts, Jujing 24 parts, Hupu 12 parts, Fuling 9 parts, Zhugancao 6 parts.

[0050] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0051] Comparative Example 3:

[0052] A traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: Gualou 27 parts, Qingbanxia 12 parts, Danshanxing 12 parts, Jujing 12 parts, Chenpi 12 parts, Fuling 9 parts, Zhugancao 6 parts.

[0053] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0054] Comparative Example 4:

[0055] A traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: Gualou 27 parts, Qingbanxia 12 parts, Danshanxing 12 parts, Jujing 24 parts, Hupu 12 parts, Chenpi 12 parts, Fuling 9 parts, Zhugancao 6 parts.

[0056] The preparation method of the traditional Chinese medicine composition comprises the following steps:

[0057] Gualou, Qingbanxia, Danshanxing, Jujing, Hupu, Chenpi, Fuling and Zhugancao are decocted with water, the first decoction is filtered after 1.5 hours to obtain a first filtrate, the filter residue is decocted with water again for 1.5 hours, and a second filtrate is obtained by filtration, and the first filtrate and the second filtrate are combined and concentrated to obtain a concentrated liquid.

[0058] Effect Example:

[0059] Effect Example 1: Influence of the traditional Chinese medicine composition on an experimental animal model of myocardial infarction

[0060] 1.1 Animals:

[0061] Male Sprague Dawley rats, SPF level, 180g-200g, provided by the Experimental Animal Center of Heilongjiang University of Chinese Medicine.

[0062] 1.2 Main drugs and reagents:

[0063] The traditional Chinese medicine composition granules prepared in Examples 1-2 and Comparative Examples 1-4 of the present application. The positive control drug Shen Song Yangxin Capsules are purchased from Beijing Yiling Pharmaceutical Co., Ltd.

[0064] 2. Modeling, grouping and administration:

[0065] 2.1 Myocardial infarction rat modeling method:

[0066] Modeling method: Take 90 rats, anesthetize and connect to a respirator, intubate, open the chest to expose the heart, and can see the left coronary artery descending branch starting part between the lower margin of the left auricle and the pulmonary artery conus. Ligate the coronary artery at a distance of 0.1-0.2 mm from the lower margin of the left auricle. After observing for several minutes, after complete hemostasis, layer by layer close the chest, and postoperative intramuscular injection of penicillin sodium 2x10 5 U / d, qd, for 3 consecutive days to resist infection.

[0067] On the third day after the operation, after sevoflurane inhalation anesthesia, observe the cardiac color Doppler ultrasound to detect the modeling effect, measure EF% according to the beating amplitude of the left ventricular myocardium, and eliminate unqualified models. Elimination criteria: eliminate those whose infarct area does not reach 30-40% of the left ventricular area, those whose infarct area exceeds the requirement, and those who have severe pericardial effusion.

[0068] 2.2 Grouping:

[0069] A total of 72 rats were successfully modeled, and these rats were randomly divided into 8 groups, 9 rats in each group. They are the model group, Examples 1-2 group, Comparative Examples 1-4 group, and positive control group.

[0070] In addition, another 9 normal healthy rats were subjected to sham operation treatment as a blank control group. These rats only take the same size needle at the left coronary artery descending branch position between the lower margin of the left auricle and the pulmonary artery conus without knot, and the rest of the operation is the same as above.

[0071] 2.3 Administration:

[0072] Examples 1-2 group, Comparative Examples 1-4 group, and positive control group are all 10 g·kg -1 (The positive control deducts accessories according to crude drug amount to adjust to the same dose as the experimental group), using gavage administration, the normal group and the model group are given the same volume of normal saline, the gavage volume is 10 mL·kg -1 , once a day, for 6 consecutive weeks.

[0073] 3. Detection index:

[0074] Determination of creatine kinase isoenzyme MB (CK-MB), troponin (c-TNT) and lactate dehydrogenase (LDH) in serum of rat aorta: after 6 weeks of administration, the rat was opened to expose the abdominal aorta, and 3-4 mL of blood was taken for centrifugation to obtain the upper serum, and the content of CK-MB, c-TNT and LDH in serum of rat aorta was detected.

[0075] 4. Statistical analysis method:

[0076] SPSS 23.0 statistical software was used for data analysis, and the measurement data were expressed as mean ± standard deviation (mean ± SD); single factor analysis of variance (One-way ANOVA) was used for comparison among multiple groups, LSD test was used for variance test, and Euskal-walli SH method was used for non-parametric test when the variance was not equal; P<0.05 was considered to have statistically significant difference.

[0077] 5. Experimental results:

[0078] The content levels of CK-MB, c-TNT and LDH in serum of rat aorta are shown in Table 1, and these indicators are markers of myocardial injury in rats. The experimental results show that the content levels of CK-MB, c-TNT and LDH in serum of rats in the positive control group, Example 1-2 group and Comparative Example 1-4 group are reduced to different degrees compared with the model group. Among them, Example 1 has the best effect on the above three indicators, and is significantly better than the positive control group (p<0.05). #

[0079] The experimental results of Comparative Example 1-4 show that changing the types of some raw materials in the traditional Chinese medicine composition of the application (see Comparative Example 1 and Comparative Example 2), reducing some flavors of the traditional Chinese medicine composition of the application (see Comparative Example 3) and changing the preparation method of the traditional Chinese medicine composition of the application (especially omitting the micronization step in the preparation process) (see Comparative Example 4) will significantly reduce the efficacy of the traditional Chinese medicine composition of the application. Therefore, the types and amount ratios of the raw materials used in the traditional Chinese medicine composition of the application and the preparation method of the traditional Chinese medicine composition of the application have a very significant effect on the efficacy of the traditional Chinese medicine composition of the application.

[0080] Table 1: Effect of the traditional Chinese medicine composition of the application on the levels of CK-MB, c-TNT and LDH in serum of myocardial infarction rats of aorta (mean ± SD, n = 9)

[0081] Group CK-MB (ng / mL) c-TNT (pg / mL) LDH (ng / mL) blank control group 0.179±0.041 0.256±0.125 60.27±9.62 model group 0.528±0.115 0.792±0.306 109.74±19.46 positive control group 0.307 ± 0.108 ** ]] 0.438 ± 0.198 *** ]] 84.37 ± 12.01 ** ]] Example 1 group 0.236 ± 0.087 ***,# ]] 0.373 ± 0.186 ***,# ]] 70.13 ± 9.57 ***,# ]] Example 2 group 0.261 ± 0.074 *** ]] 0.342 ± 0.175 ***,# ]] 73.59 ± 9.42 *** ]] Comparative Example 1 group 0.423±0.107 0.637±0.243 101.25±10.53 Comparative Example 2 group 0.401±0.105 0.641±0.214 99.76±10.85 Comparative Example 3 group 0.464±0.113 0.605±0.261 103.07±10.88 Comparative Example 4 group 0.345 ± 0.109 ** ]] 0.454 ± 0.213 ** ]] 91.61 ± 9.94 * ]]

[0082] Note: compared with the model group, * p<0.05, ** p<0.01, *** ​P < 0.001; compared with the positive control group, # P < 0.05. Effect Example 2: Study on the analgesic effect of the traditional Chinese medicine composition in the application

[0083] 1. Main materials and methods

[0084] 1.1 Animals:

[0085] Male ICR mice, 18-22 g, were provided by the Experimental Animal Center of Heilongjiang University of Chinese Medicine.

[0086] The traditional Chinese medicine composition particles prepared in Examples 1-2 and Comparative Examples 1-4 of the application. The positive control drug is Shensong Yangxin Capsules, which was purchased from Beijing Yiling Pharmaceutical Co., Ltd.

[0087] 2. Modeling, grouping, drug administration and detection indicators:

[0088] The hot plate instrument was adjusted to (55±0.5)℃, and the mice were screened. The time from the mouse being put into the hot plate to licking the hind foot was recorded as the pain threshold value of the mouse. Seventy-two male mice with a pain threshold value within 30 s were randomly divided into 8 groups, 9 mice in each group. They were blank control group, Example 1-2 group, Comparative Example 1-4 group and positive control group, respectively.

[0089] The dosage of Example 1-2 group, Comparative Example 1-4 group and positive control group was 20 g·kg -1 (the positive control was deducted from the auxiliary material according to the crude drug amount to adjust to the same dosage as the experimental group), and the model group was given the same volume of normal saline by gavage, with a gavage volume of 10 mL·kg -1 , once a day, for 7 consecutive days.

[0090] One hour after gavage on the 7th day, the mice were placed in the hot plate instrument to measure the pain threshold value of the mice.

[0091] 3. Statistical analysis method:

[0092] SPSS23.0 statistical software was used for data analysis. The measurement data was expressed as mean±standard deviation (mean±SD). One-way ANOVA was used for comparison among multiple groups. LSD test was used for variance test, Euskal-walli SH method was used for non-parametric test when the variance was not equal. P < 0.05 was considered to have statistically significant difference.

[0093] 4. Experimental results:

[0094] The analgesic effects of the traditional Chinese medicine composition of the present application are shown in Table 2. The experimental results show that the Example 1-2 group and the Comparative Example 1-4 group all have analgesic effects to different degrees compared with the model group, but it can be seen that the analgesic effect of the positive control drug Shensong Yangxin Capsule is relatively poor. Among them, the analgesic effect of the Example 1-2 group is the strongest and significantly better than that of the positive control group (p<0.01). ## p<0.01).

[0095] The experimental results of the Comparative Example 1-4 group show that changing the types of some raw materials in the traditional Chinese medicine composition of the present application (see Comparative Example 1 group and Comparative Example 2 group), subtracting some medicinal flavors of the traditional Chinese medicine composition of the present application (see Comparative Example 3 group), and changing the preparation method of the traditional Chinese medicine composition of the present application (especially omitting the micronization step in the preparation process) (see Comparative Example 4 group) will all cause the analgesic effect of the traditional Chinese medicine composition of the present application to decrease to different degrees. It can be seen from this that the types and dosage proportions of the raw materials used in the traditional Chinese medicine composition of the present application and the preparation method of the traditional Chinese medicine composition of the present application all have a very significant influence on the curative effect of the traditional Chinese medicine composition of the present application.

[0096] Table 2: Analgesic effect study of the traditional Chinese medicine composition of the present application (mean ± SD, n = 9)

[0097] Group pain threshold (s) blank control group 16.98±2.65 positive control group 18.31±3.02 Example 1 group 25.37 ± 3.41 ***,## <!-- 6 -->]] Example 2 group 24.25 ± 4.05 ***,## ]] Comparative Example 1 group 18.84±3.13 Comparative Example 2 group 19.58±2.94 Comparative Example 3 group 19.52±3.27 Comparative Example 4 group 22.24 ± 3.16 **,# ]]

[0098] Note: compared with the blank control group, * p<0.05, *** p<0.001; compared with the positive control group, ## p<0.01, # p<0.05.

[0099] Example 3: Preliminary clinical trial of the traditional Chinese medicine composition of the present application

[0100] 1. Patient's basic situation and grouping

[0101] 60 outpatients all met the diagnostic criteria for chest pain, heart pain, and phlegm and qi obstruction type heart disease. After informed consent, they were randomly divided into the Example 1 group and the positive drug (Shensong Yangxin Capsule) group, each with 30 cases. Among them, the Example 1 group had 16 male and 14 female patients, aged 28-69 years. The positive control group had 20 male and 10 female patients, aged 27-65 years. There was no significant statistical difference in gender, age, and disease duration between the two groups of patients (P>0.05).

[0102] 2. Dosing regimen

[0103] In the present study, all patients with chest pain, phlegm and qi obstruction type of heart disease were given the basic treatment of clinical routine method. On this basis, the patients in Example 1 group were given the granules prepared in Example 1 above (0.2 g once, 3 times a day, continuous administration for 4 weeks), and the patients in the positive control group were given the positive drug Songshenyangxin Capsule (0.4 g once, 3 times a day, continuous administration for 4 weeks). After the treatment, the clinical treatment effects of the patients in the two groups were evaluated.

[0104] 3. Observation index

[0105] (1) The electrocardiogram of the patients was detected once before the start of the study and once after the end of the study, and the results of the two electrocardiograms were compared.

[0106] (2) The changes in the clinical symptoms of the patients in the two groups before and after the treatment were observed, including chest pain, chest tightness, palpitation, dizziness, headache and insomnia, and were recorded as 1, 2 and 3 points according to mild, moderate and severe, respectively.

[0107] 4. Evaluation standard

[0108] (1) Electrocardiogram efficacy standard:

[0109] Marked effect: the ST segment and T wave of the electrocardiogram of each lead returned to normal or the electrocardiogram was significantly improved, such as the T wave changed from inversion to upright, etc.

[0110] Effect: the electrocardiogram was improved but did not reach the standard, such as the raised ST segment decreased by 0.5-0.1 mV, the T wave changed from inversion to shallow or flat, or from flat to upright.

[0111] No effect: the electrocardiogram was not improved.

[0112] (2) Clinical symptom evaluation standard:

[0113] Marked effect: the original symptoms completely disappeared or significantly reduced, and the symptom score decreased by ≥80%;

[0114] Effect: the symptoms were improved, and the symptom score decreased by ≥20% and <80%;

[0115] No effect: the original symptoms were not improved, and the symptom score decreased by <20%.

[0116] 5. Research results

[0117] Before the start of the study and after the end of the study, the electrocardiogram detection results of the patients in Example 1 group and the positive drug group are shown in Table 3.

[0118] Table 3: Electrocardiogram detection results of patients in Example 1 group and positive drug group

[0119] Group excellent effective ineffective total effective rate (%) Example 1 group 18 10 2 93.3 positive drug group 10 13 7 76.7

[0120] As can be seen from the results in Table 3, at the end of the study, the improvement in electrocardiogram of the patients in the Example 1 group was significantly superior to that of the positive control group.

[0121] The results of the clinical symptom evaluation of the patients in the Example 1 group and the positive drug group before the start of the study and after the end of the study are shown in Table 4.

[0122] Table 4: Results of the clinical symptom evaluation of the patients in the Example 1 group and the positive drug group

[0123]

[0124]

[0125] As can be seen from the results in Table 4, at the end of the study, the improvement in chest pain, chest tightness, palpitation, headache and insomnia of the patients in the Example 1 group was significantly superior to that of the positive control group.

[0126] The improvement in dizziness of the patients in the Example 1 group was comparable to that of the positive control group.

[0127] In summary, the Chinese medicinal composition of the present application has the effects of tonifying qi, relieving chest and removing obstruction, and is mainly used for treating chest pain, cardiovascular diseases of phlegm and qi obstruction, and is particularly suitable for treating coronary heart disease and angina pectoris with the above-mentioned symptoms, and has a broad clinical application prospect and economic value.

[0128] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application belong to the scope of the claims of the present application and their equivalents, then the present application is also intended to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating cardiovascular disease of phlegm and qi obstruction type, characterized in that: The traditional Chinese medicine composition is made of raw medicinal materials in the following weight proportions: Perilla fruit 5-50 parts, Bai-Zhe-Shi 1-40 parts, Arisaema cum Bile 1-40 parts, Fructus Aurantii 1-40 parts, Magnolia officinalis 1-40 parts, Citrus reticulata 1-40 parts, Poria cocos 1-20 parts, and Radix Glycyrrhizae 1-20 parts. ​ 2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is made of raw medicinal materials in the following weight proportions: Perilla fruit 10-40 parts, Bai-Zhe-Shi 5-20 parts, Arisaema cum Bile 5-20 parts, Fructus Aurantii 5-20 parts, Magnolia officinalis 5-20 parts, Citrus reticulata 5-20 parts, Poria cocos 1-15 parts, and Radix Glycyrrhizae 1-10 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is made of raw medicinal materials in the following weight proportions: Perilla fruit 27 parts, Bai-Zhe-Shi 12 parts, Arisaema cum Bile 12 parts, Fructus Aurantii 12 parts, Magnolia officinalis 12 parts, Citrus reticulata 12 parts, Poria cocos 9 parts, and Radix Glycyrrhizae 6 parts.

4. The preparation method of the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: (1) mixing Arisaema cum Bile, Magnolia officinalis, and Citrus reticulata to obtain a mixture of ultrafine powders; (2) decocting Perilla fruit, Bai-Zhe-Shi, Fructus Aurantii, Poria cocos, and Radix Glycyrrhizae with water, filtering the first decoction after 1-4 hours of the first decoction, adding water to the residue to decoct for 1-4 hours, filtering the second decoction, and combining the first and second decoctions to obtain a concentrated solution; (3) spraying the mixture of ultrafine powders obtained in step (1) into the concentrated solution obtained in step (2) to obtain the traditional Chinese medicine composition granules.

5. The method of claim 4, wherein: In step (1), the fineness of the ultrafine powder is 100 mesh.

6. The method of making according to claim 4 or claim 5, wherein: In step (2), the time for the first and second decoctions is 1.5 hours.

7. Use of the traditional Chinese medicine composition of any one of claims 1 to 3 or the traditional Chinese medicine composition prepared by the preparation method of any one of claims 4 to 6 in the preparation of a medicine for treating cardiovascular diseases of the type of chest obstruction caused by phlegm and qi.

8. Use according to claim 7, characterized in that: The cardiovascular diseases are coronary heart disease, angina pectoris, or myocardial infarction.

9. Use according to claim 7 or claim 8, characterised in that: The dosage form of the medicine is granules, tablets, oral liquid, or capsules.

10. Use according to claim 9, characterized in that: The dosage form of the medicine is granules.

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