Traditional Chinese medicine composition for treating thoracic obstruction and blood stasis type cardiovascular diseases as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating thoracic obstruction and blood stasis type cardiovascular diseases and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from radix salviae miltiorrhizae, radix curcumae, rhizoma corydalis, ligusticum wallichii, pseudo-ginseng, rhizoma pinelliae preparata, fructus trichosanthis, fructus aurantii immaturus, allium macrostemon and cassia twig. The traditional Chinese medicine composition disclosed by the invention has the effects of promoting blood circulation to remove blood stasis and relieving pain, is mainly used for treating chest stuffiness and pains and qi stagnation and blood stasis 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 invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating chest obstruction and blood stasis type cardiovascular diseases, and a preparation method and application thereof. Background Art

[0002] Cardiovascular disease generally refers to medical conditions that affect the structure or function of the heart, such as coronary artery disease, heart attack, angina pectoris, arrhythmia or irregular heartbeat, heart failure, valvular heart disease, congenital heart disease, myocardial disease, pericardial disease, aortic disease and Marfan syndrome, as well as other vascular diseases. In recent years, coronary heart disease and angina pectoris are among the most common cardiovascular diseases, seriously threatening the health and life of humans, especially the middle-aged and elderly. At present, there are various limitations in the treatment of coronary heart disease and angina pectoris. Western medicine is mainly nitrate compounds, beta-blockers and calcium antagonists, but these drugs can only relieve symptoms, treat the symptoms but not the root cause, and also have certain toxic side effects. In addition to Western medicine, in the process of searching for new drugs, traditional Chinese medicine and natural products have attracted much attention.

[0003] Traditional Chinese medicine calls coronary heart disease and angina pectoris "chest pain and heartache". Its main clinical manifestations are chest tightness and pain, palpitations and shortness of breath, and even excruciating chest pain. If not treated in time, it can often 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 mostly "chest pain and heartache, qi stagnation and blood stasis".

[0004] At present, there are many Chinese patent medicines and Chinese medicine prescriptions for the treatment of coronary heart disease and angina pectoris in clinical practice, such as Tongxinluo Capsules, Compound Danshen Tablets, Shuxiong Granules, Xuefu Zhuyu Granules, etc., but most of them have defects such as unsatisfactory treatment effects and slow onset of action. In addition, although the use of Chinese herbal decoctions can be adjusted individually according to the actual situation of the patient, Chinese herbal decoctions are heavy in taste and may irritate the gastrointestinal tract, and are inconvenient to carry, resulting in poor compliance of patients with medication, making it difficult for patients to persist in long-term use.

[0005] In view of this, the present invention uses modern pharmacological research methods, through in-depth research and screening of classic prescriptions of traditional Chinese medicine for treating cardiovascular diseases of the chest obstruction and blood stasis type, to develop a Chinese medicine composition and a Chinese patent medicine preparation method that are effective in treating cardiovascular diseases of the chest obstruction and blood stasis type. Summary of the invention

[0006] In order to solve the above technical problems, the present invention provides a Chinese medicine composition and its application which can effectively treat cardiovascular diseases of chest obstruction and blood stasis type.

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

[0008] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating cardiovascular diseases of chest obstruction and blood stasis type, wherein the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-30 parts of Salvia miltiorrhiza, 5-30 parts of Curcuma aromatica, 5-30 parts of Corydalis yanhusuo, 5-10 parts of Ligusticum chuanxiong, 5-30 parts of Panax notoginseng, 5-30 parts of Pinellia ternata, 5-30 parts of Trichosanthes kirilowii, 5-30 parts of Citrus aurantium, 5-30 parts of Allium macrostemon, and 1-20 parts of cinnamon twig.

[0009] As an optional manner, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15-25 parts of Salvia miltiorrhiza, 10-20 parts of Curcuma aromatica, 10-20 parts of Corydalis yanhusuo, 10-20 parts of Ligusticum chuanxiong, 10-20 parts of Panax notoginseng, 10-20 parts of Pinellia ternata, 10-20 parts of Trichosanthes kirilowii, 10-20 parts of Citrus aurantium, 10-20 parts of Allium macrostemon, and 5-10 parts of cinnamon twig.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 21 parts of Salvia miltiorrhiza, 18 parts of Curcuma aromatica, 12 parts of Corydalis yanhusuo, 15 parts of Ligusticum chuanxiong, 15 parts of Panax notoginseng, 12 parts of Pinellia ternata, 15 parts of Trichosanthes kirilowii, 12 parts of Citrus aurantium, 12 parts of Allium macrostemon, and 9 parts of cinnamon twig.

[0011] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition described in the first aspect, the preparation method comprising the following steps:

[0012] (1) Mix and ultrafinely grind Danshen, Curcuma, Chuanxiong, and Cinnamon to prepare mixed ultrafine powder;

[0013] (2) adding water to decoct Corydalis yanhusuo, Panax notoginseng, Pinellia ternata, Trichosanthes kirilowii, Fructus aurantii, and Radix Allii macrostemonis; after the first decoction for 1-3 hours, filtering to obtain a primary filtrate; adding water to the filter residue and decoct for another 1-3 hours, filtering to obtain a secondary filtrate; combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution;

[0014] (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

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

[0016] As an optional manner, in the above preparation method, in step (2), the time for the first decoction and the second decoction are both 1 hour.

[0017] In the third aspect, the present invention provides the use of the Chinese medicine composition described in the first aspect or the Chinese medicine composition prepared by the preparation method described in the second aspect in the preparation of a drug for treating cardiovascular diseases of chest obstruction and blood stasis type.

[0018] As an option, 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 invention has the following beneficial effects:

[0022] The Chinese medicine composition of the present invention has the effects of promoting blood circulation and removing blood stasis, widening the intestine and relieving pain, and is mainly used to treat chest obstruction and heart pain, and cardiovascular diseases of qi stagnation and blood stasis type, and is particularly suitable for patients with coronary heart disease and angina pectoris with the above symptoms. In addition, on the basis of the traditional medical prescription, the present invention utilizes modern preparation technology and performs in-depth optimization, adopts dynamic decoction technology and one-step granulation technology, and the preparation method of the present invention has the advantages of simple preparation technology, high efficiency, energy saving, less destruction of effective ingredients, etc. DETAILED DESCRIPTION

[0023] The efficacy and main treatment of each medicinal ingredient in the Chinese medicine composition of the present invention are as follows:

[0024] As used herein, "Danshen" refers to the dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family. Salvia miltiorrhiza has the effects of promoting blood circulation and removing blood stasis, relieving pain from menstruation, clearing the heart and relieving restlessness, cooling blood and eliminating carbuncle. It is used for chest pain, abdominal pain, accumulation of masses, heat arthralgia, restlessness and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0025] As used herein, "curcuma" refers to the dried root of Curcuma wenyujin YHChen et C.Ling, Curcuma longa L., Curcuma kwangsiensis SGLee et CFLiang or Curcuma phaeocaulis Val. of the Zingiberaceae family. Curcuma is pungent, bitter and cold. It can promote blood circulation and relieve pain, promote qi and dispel scabies, clear the heart and relieve depression, and promote bile and relieve jaundice. It is a blood-activating and analgesic drug under the category of blood-activating and stasis-removing drugs. It is used to treat amenorrhea, dysmenorrhea, fever, coma, epilepsy, jaundice, dark urine, chest and abdominal distension and pain, and tingling.

[0026] As used herein, "Yirusuo" is the tuber of the plant Cordalis ambigua Cham.et Schlecht. of the Poppy family. Yanhusuo is warm in nature, pungent and bitter in taste. It can promote blood circulation and dissipate blood stasis, regulate qi and relieve pain. It is a blood-activating and analgesic drug classified under blood-activating and stasis-removing drugs. It can treat pain caused by qi stagnation and blood stasis in various parts of the body, dysmenorrhea, amenorrhea, abdominal masses, postpartum blood stasis, injuries from falls, and hernia pain.

[0027] As used herein, "chuanxiong" refers to the rhizome of the plant Chuanxiong Ligusticum chuam.iong Hort. of the Umbelliferae family. It is warm in nature and pungent in taste. It can promote blood circulation and qi, dispel wind and relieve pain. It is a blood-activating and analgesic drug under the category of blood-activating and stasis-removing drugs. It is used for chest pain, chest and rib pain, swelling and pain due to falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to urinary tract infections, headache, and rheumatic pain.

[0028] As used herein, "Sanqi" refers to the root and rhizome of Panax notoginseng (Burk.) FHChen. of the Araliaceae family. It is warm in nature, sweet and slightly bitter in taste. It can dissipate blood stasis and stop bleeding, reduce swelling and relieve pain. It is a blood stasis-removing and hemostatic drug under the category of hemostatic drugs. It is used to treat hemoptysis, hematemesis, epistaxis, blood in stool, metrorrhagia, bleeding due to trauma, stabbing pain in the chest and abdomen, and swelling and pain due to falls.

[0029] As used herein, "Pinellia" is the dried tuber of Pinellia ternata (Thunb.) Breit, a plant of the Araceae family. It is pungent, warm, and toxic. It enters the spleen, stomach, and lung meridians. It dries dampness and resolves phlegm, relieves adverse reactions and stops vomiting, and eliminates lumps and resolves knots. It is used for cough and asthma due to excessive phlegm, dizziness and palpitations caused by phlegm and fluid, dizziness caused by wind and phlegm, headache caused by phlegm, vomiting and nausea, chest and abdominal distension, and plum-pit qi syndrome; it is used raw for external treatment of carbuncle, phlegm nodules, and phlegm nodules. Ginger Pinellia is often used to relieve adverse reactions and stop vomiting.

[0030] As used herein, "Trichosanthes klrllowll Maxim." is the mature fruit of the plant Trichosanthes klrllowll Maxim. of the Cucurbitaceae family. It is cold in nature, sweet and slightly bitter in taste. It clears away heat and dispels phlegm, relieves chest tightness and dissipates stagnation, moistens and lubricates the intestines. It is a heat-clearing and phlegm-clearing medicine under the category of expectorant, cough-relieving and asthma-relieving medicine. It is used to treat lung-heat cough, turbid yellow and thick phlegm, chest pain, chest congestion, breast abscess, lung abscess, intestinal abscess swelling and pain, and constipation. It has the functions of resisting hypoxia, myocardial ischemia, arrhythmia, and platelet aggregation.

[0031] As used herein, "Zhi Shi" refers to the young fruit of Citrus aurantium L., a plant of the Rutaceae family. It is slightly cold in nature, bitter, pungent, and sour in taste. It can dissipate qi and eliminate stagnation, resolve phlegm, and relieve lumps. It is a Qi-regulating drug. It is used to treat abdominal distension and pain caused by food stagnation, constipation due to heat accumulation, abdominal distension and pain, diarrhea due to damp heat, tenesmus, gastroptosis, uterine prolapse, rectal prolapse, etc.

[0032] As used herein, "Xiebai" refers to the bulb of Allium macrostemon Bge. or Alliumchinense G.Don, a plant of the Liliaceae family. It is warm in nature, pungent and bitter in taste. It promotes yang and dissipates stagnation, promotes qi and relieves stagnation. It is a Qi-regulating drug. It is used to treat chest pain, phlegm and cough, and heaviness after diarrhea. For external use, it can be crushed and applied or the juice can be applied.

[0033] As used herein, "cinnamon twig" refers to the young branches of Cinnamomum cassia Presl., a plant of the Lauraceae family. It is pungent, sweet, and warm in nature. It can relieve muscle pain, warm the meridians and dredge the blood vessels, promote yang and transform qi, and balance and lower qi. It is a pungent and warm antipyretic drug. It is used to treat colds caused by wind and cold, cold pain in the abdomen, amenorrhea caused by cold blood, joint pain, phlegm and fluid retention, edema, palpitations, and running pig.

[0034] The present invention will be further described with reference to specific embodiments below. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the scope of the present invention.

[0035] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0036] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0037] Preparation Example:

[0038] Embodiment 1:

[0039] A traditional Chinese medicine composition for treating cardiovascular diseases of chest obstruction and blood stasis type, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 21 parts of salvia miltiorrhiza, 18 parts of curcuma, 12 parts of corydalis, 15 parts of ligusticum chuanxiong, 15 parts of notoginseng, 12 parts of pinellia, 15 parts of trichosanthes, 12 parts of immature bitter orange, 12 parts of allium macrostemon, and 9 parts of cinnamon twig.

[0040] The preparation method of the Chinese medicine composition comprises the following steps:

[0041] (1) mixing and ultrafine grinding Danshen, Curcuma, Chuanxiong and Cinnamon to prepare mixed ultrafine powder, wherein the fineness of the ultrafine powder is 100 mesh;

[0042] (2) Add water to decocting Corydalis yanhusuo, Panax notoginseng, Pinellia ternata, Trichosanthes kirilowii, Fructus aurantii, and Radix Allii Macrostemonis, decoct for 1 hour, filter to obtain a primary filtrate, add water to the residue and decoct for another hour, filter to obtain a secondary filtrate, combine the primary filtrate and the secondary filtrate, and concentrate to obtain a concentrated solution;

[0043] (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

[0044] Embodiment 2:

[0045] A traditional Chinese medicine composition for treating cardiovascular diseases of chest obstruction and blood stasis type, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 18 parts of salvia miltiorrhiza, 21 parts of curcuma, 15 parts of corydalis, 15 parts of ligusticum chuanxiong, 12 parts of notoginseng, 12 parts of pinellia, 15 parts of whole trichosanthes, 12 parts of immature bitter orange, 12 parts of allium macrostemon, and 9 parts of cinnamon twig.

[0046] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0047] Comparative Example 1:

[0048] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 21 parts of salvia miltiorrhiza, 18 parts of bupleurum, 12 parts of corydalis, 15 parts of ligusticum chuanxiong, 15 parts of notoginseng, 12 parts of pinellia, 15 parts of trichosanthes, 12 parts of immature bitter orange, 12 parts of allium macrostemon, and 9 parts of cinnamon twig.

[0049] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0050] Comparative Example 2:

[0051] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 21 parts of salvia miltiorrhiza, 18 parts of curcuma, 12 parts of corydalis, 15 parts of ligusticum chuanxiong, 15 parts of notoginseng, 12 parts of pinellia, 15 parts of trichosanthes, 12 parts of immature bitter orange, 12 parts of allium macrostemon, and 9 parts of cinnamon twig.

[0052] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0053] Comparative Example 3:

[0054] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 28 parts of salvia miltiorrhiza, 26 parts of curcuma, 12 parts of corydalis, 15 parts of notoginseng, 12 parts of pinellia, 15 parts of whole trichosanthes, 12 parts of immature bitter orange, 12 parts of allium macrostemon, and 9 parts of cinnamon twig.

[0055] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0056] Comparative Example 4:

[0057] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 21 parts of salvia miltiorrhiza, 18 parts of curcuma, 12 parts of corydalis, 15 parts of ligusticum chuanxiong, 15 parts of notoginseng, 12 parts of pinellia, 15 parts of trichosanthes, 12 parts of immature bitter orange, 12 parts of allium macrostemon, and 9 parts of cinnamon twig.

[0058] The preparation method of the Chinese medicine composition comprises the following steps:

[0059] Add water to decoct Danshen, Curcuma, Ligusticum chuanxiong, Cinnamon twig, Corydalis, Panax notoginseng, Pinellia ternata, Trichosanthes kirilowii, Immature bitter orange, and Allium macrostemon to obtain a primary filtrate after the first decoction for 1 hour. Add water to the residue and decoct for another 1 hour, filter to obtain a secondary filtrate, combine the primary filtrate and the secondary filtrate, and concentrate to obtain a concentrated solution.

[0060] Effect embodiment:

[0061] Effect Example 1: Effect of the Chinese medicine composition of the present invention on the experimental animal model of myocardial infarction 1. Main materials and methods

[0062] 1.1 Animals:

[0063] Male Sprague Dawley rats, SPF grade, 180g-200g, provided by the Experimental Animal Center of Heilongjiang University of Chinese Medicine.

[0064] 1.2 Main drugs and reagents:

[0065] The Chinese medicine composition granules prepared in Examples 1-2 and Comparative Examples 1-4 of the present invention. The positive control drug Xuefu Zhuyu Granules was purchased from Jiangsu Chenpai Pharmaceutical Group Co., Ltd.

[0066] 2. Modeling, grouping and drug administration:

[0067] 2.1 Myocardial infarction rat modeling method:

[0068] Modeling method: 90 rats were anesthetized and connected to a ventilator. After intubation, the heart was exposed by opening the chest. The origin of the left anterior descending coronary artery was visible between the lower edge of the left atrial appendage and the pulmonary artery cone. The coronary artery was ligated 0.1-0.2 mm away from the lower edge of the left atrial appendage. After a few minutes of observation, the chest was closed layer by layer after complete hemostasis. After the operation, sodium penicillin 2×10 5 U / d, qd, continuous anti-infection for 3 days.

[0069] On the third day after surgery, after inhalation anesthesia with sevoflurane, the modeling effect was observed by cardiac ultrasound, and the EF% was measured according to the pulsation amplitude of the left ventricular myocardium, and unqualified models were eliminated. The elimination criteria were: those with infarction area less than 30-40% of the left ventricular area, those with infarction area exceeding the requirement, and those with severe pericardial effusion.

[0070] 2.2 Grouping:

[0071] A total of 80 rats were successfully modeled and randomly divided into 8 groups, each with 10 rats, namely the model group, Example 1-2 group, Comparative Example 1-4 group, and positive control group.

[0072] In addition, 10 normal healthy rats were subjected to sham surgery as a blank control group. These rats were sutured with the same size needle at the left anterior descending coronary artery between the lower edge of the left atrial appendage and the pulmonary artery cone without tying a knot, and the rest of the operation was the same as above.

[0073] 2.3 Administration:

[0074] The dosage of Example 1-2, Comparative Example 1-4 and Positive Control Group was 10 g·kg -1 (The positive control was adjusted to the same dosage as the experimental group according to the amount of crude drug after deducting the auxiliary materials). The normal group and the model group were given equal volumes of saline, and the gavage volume was 10 mL kg -1 , once a day, for 6 consecutive weeks.

[0075] 3. Detection indicators:

[0076] Determination of CK-MB, c-TNT and LDH content in rat aortic serum: After 6 weeks of administration, the rats were opened to expose the abdominal aorta, 3-4 ml of blood was collected, and the upper serum was collected by centrifugation to detect the levels of CK-MB, c-TNT and LDH in the rat aortic serum.

[0077] 4. Statistical analysis methods:

[0078] SPSS23.0 statistical software was used for data analysis, and the measurement data were expressed as mean±standard deviation (mean±SD). One-way ANOVA was used for comparison among multiple groups. LSD test was used for equal variance test, and Euskal-Walli SH method was used for non-parametric test for unequal variance. P<0.05 was considered statistically significant.

[0079] 5. Experimental results:

[0080] Table 1 shows the levels of CK-MB, c-TNT, and LDH in rat aortic serum, which are markers of myocardial injury in rats. The experimental results show that compared with the model group, the levels of CK-MB, c-TNT, and LDH in the serum of the positive control group, Example 1-2 groups, and Comparative Example 1-4 groups were all reduced to varying degrees. Among them, Example 1 had the best effect on the above three indicators and was significantly better than the positive control group ( # p<0.05, ## p<0.01).

[0081] The experimental results of Comparative Examples 1-4 show that changing the types of some raw materials in the Chinese medicine composition of the present invention (see Comparative Example 1), changing the processing methods of some raw materials in the Chinese medicine composition of the present invention (see Comparative Example 2), subtracting some medicinal flavors of the Chinese medicine composition of the present invention (see Comparative Example 3) and changing the preparation method of the Chinese medicine composition of the present invention (especially omitting the micronization step in the preparation process) (see Comparative Example 4) will all lead to a significant decrease in the efficacy of the Chinese medicine composition of the present invention. It can be seen that the types and dosage ratios of the raw materials used in the Chinese medicine composition of the present invention and the preparation method of the Chinese medicine composition of the present invention have a very significant effect on the efficacy of the Chinese medicine composition of the present invention.

[0082] Table 1: Effect of the Chinese medicine composition of the present invention on the levels of CK-MB, c-TNT and LDH in aorta serum of rats with myocardial infarction (mean ± SD, n = 10)

[0083]

[0084]

[0085] Note: Compared with the model group, * p<0.05, ** p<0.01, *** p<0.001; compared with the positive control group, # p<0.05, ## p<0.01.

[0086] Effect Example 2: Effect of the Chinese medicine composition of the present invention on blood rheology in blood stasis experimental animal model 1. Main materials and methods

[0087] 1.1 Animals:

[0088] Male Sprague Dawley rats, SPF grade, 180g-200g, provided by the Experimental Animal Center of Heilongjiang University of Chinese Medicine.

[0089] 1.2 Main drugs and reagents:

[0090] The Chinese medicine composition granules prepared in Examples 1-2 and Comparative Examples 1-4 of the present invention. The positive control drug Xuefu Zhuyu Granules was purchased from Jiangsu Chenpai Pharmaceutical Group Co., Ltd.

[0091] 2. Modeling, grouping, drug administration and testing indicators:

[0092] 80 Sprague Dawley rats were randomly divided into 8 groups, each with 10 rats, namely the model group, Example 1-2 groups, Comparative Example 1-4 groups and the positive control group.

[0093] The dosage of Example 1-2, Comparative Example 1-4 and Positive Control Group was 10 g·kg -1 (The positive control group was adjusted to the same dosage as the experimental group according to the amount of crude drug after deducting the auxiliary materials). The model group was given an equal volume of normal saline, and the gavage volume was 10 mL kg -1 , once a day, for 7 consecutive days.

[0094] One hour after the last administration, rats in each group were subcutaneously injected with epinephrine hydrochloride 0.08mL / 10g (10μg / mL) for a total of 2 times with an interval of 4 hours. Between the 2 injections of epinephrine hydrochloride, the rats were immersed in ice water for 5min to form a blood stasis model.

[0095] After treatment, the rats in each group were fasted but not watered. The next morning, blood was collected and placed in a centrifuge tube containing a small amount of sodium heparin. The whole blood viscosity and plasma viscosity were measured using a blood viscosity meter.

[0096] 3. Statistical analysis methods:

[0097] SPSS23.0 statistical software was used for data analysis, and the measurement data were expressed as mean±standard deviation (mean±SD). One-way ANOVA was used for comparison among multiple groups. LSD test was used for equal variance test, and Euskal-Walli SH method was used for non-parametric test for unequal variance. P<0.05 was considered statistically significant.

[0098] 4. Experimental results:

[0099] Table 2 shows the effect of the Chinese medicine composition of the present invention on the blood rheology of blood stasis rats. The experimental results show that compared with the model group, the whole blood viscosity and plasma viscosity of the rats in the positive control group, Example 1-2 group and Comparative Example 1-4 group all showed different degrees of reduction. Among them, Example 1 had the best effect on the above two indicators and was significantly better than the positive control group ( # p<0.05).

[0100] The experimental results of the comparative examples 1-4 groups show that changing the types of some raw materials in the Chinese medicine composition of the present invention (see comparative example 1 group), changing the processing methods of some raw materials in the Chinese medicine composition of the present invention (see comparative example 2 group), subtracting some medicinal flavors of the Chinese medicine composition of the present invention (see comparative example 3 group) and changing the preparation method of the Chinese medicine composition of the present invention (especially omitting the micronization step in the preparation process) (see comparative example 4 group) will lead to a significant decrease in the improvement effect of the Chinese medicine composition of the present invention on the blood rheology of blood stasis rats. It can be seen that the types and dosage ratios of the raw materials used in the Chinese medicine composition of the present invention and the preparation method of the Chinese medicine composition of the present invention have a very significant effect on the therapeutic effect of the Chinese medicine composition of the present invention.

[0101] Table 2: Effect of the Chinese medicine composition of the present invention on blood rheology in blood stasis rats (mean ± SD, n = 10)

[0102] Group <![CDATA[Whole blood specific viscosity (200s -1 )]]> Plasma viscosity Model Group 6.51±1.07 2.45±0.19 Positive control group <![CDATA[5.25±1.14 * ]]> <![CDATA[2.03±0.15 * ]]> Example 1 Group <![CDATA[4.08±0.94 **,# ]]> <![CDATA[1.87±0.11 **,# ]]> Example 2 Group <![CDATA[4.13±1.02 **,# ]]> <![CDATA[1.92±0.13 * ]]> Comparative Example 1 6.06±1.03 2.19±0.21 Comparative Example 2 6.01±1.12 2.14±0.18 Comparative Example 3 5.94±1.05 2.15±0.14 Comparative Example 4 <![CDATA[5.77±1.02 * ]]> <![CDATA[1.99±0.16 * ]]>

[0103] Note: Compared with the model group, * p<0.05, ** p<0.01; compared with the positive control group, # p<0.05. Effect Example 3: Study on the analgesic effect of the Chinese medicine composition of the present invention

[0104] 1. Main Materials and Methods

[0105] 1.1 Animals:

[0106] Male ICR mice, 18-22 g, were provided by the Experimental Animal Center of Heilongjiang University of Chinese Medicine. 1.2 Main drugs and reagents:

[0107] The Chinese medicine composition granules prepared in Example 1 and Comparative Examples 1-4 of the present invention. The positive control drug Xuefu Zhuyu Granules was purchased from Jiangsu Chenpai Pharmaceutical Group Co., Ltd.

[0108] 2. Modeling, grouping, drug administration and testing indicators:

[0109] The electric hot plate was adjusted to (55±0.5)°C, mice were screened, and the time from the mouse entering the hot plate to licking its hind paw was recorded as the pain threshold of the mouse. 70 male mice with a pain threshold within 30s were screened and randomly divided into 7 groups, 10 mice in each group, namely, a blank control group, Example 1 group, Comparative Examples 1-4 groups, and a positive control group.

[0110] The dosage of Example 1, Comparative Examples 1-4, and the positive control group was 20 g·kg -1 (The positive control group was adjusted to the same dosage as the experimental group according to the amount of crude drug after deducting the auxiliary materials). The model group was given an equal volume of normal saline, and the gavage volume was 10 mL kg -1 , once a day, for 7 consecutive days.

[0111] One hour after intragastric administration on the 7th day, the mice were placed on a hot plate apparatus to measure the pain threshold of the mice.

[0112] 3. Statistical analysis methods:

[0113] SPSS23.0 statistical software was used for data analysis, and the measurement data were expressed as mean±standard deviation (mean±SD). One-way ANOVA was used for comparison among multiple groups. LSD test was used for equal variance test, and Euskal-Walli SH method was used for non-parametric test for unequal variance. P<0.05 was considered statistically significant.

[0114] 4. Experimental results:

[0115] Table 3 shows the analgesic effect of the Chinese medicine composition of the present invention. The experimental results show that compared with the model group, the Example 1 group and the Comparative Examples 1-4 groups all have different degrees of analgesic effect, but it can be seen that the analgesic effect of the positive control drug Xuefu Zhuyu Granule is relatively poor. Among them, the analgesic effect of the Example 1 group is the strongest, and is significantly better than the positive control group ( ## p<0.01).

[0116] The experimental results of the comparative examples 1-4 groups show that changing the types of some raw materials in the Chinese medicine composition of the present invention (see comparative example 1 group), changing the processing methods of some raw materials in the Chinese medicine composition of the present invention (see comparative example 2 group), subtracting some medicinal flavors of the Chinese medicine composition of the present invention (see comparative example 3 group) and changing the preparation method of the Chinese medicine composition of the present invention (especially omitting the micronization step in the preparation process) (see comparative example 4 group) will all lead to different degrees of reduction in the analgesic effect of the Chinese medicine composition of the present invention. It can be seen that the types and dosage ratios of the raw materials used in the Chinese medicine composition of the present invention and the preparation method of the Chinese medicine composition of the present invention have a very significant effect on the efficacy of the Chinese medicine composition of the present invention.

[0117] Table 3: Study on the analgesic effect of the Chinese medicine composition of the present invention (mean ± SD, n = 10)

[0118] Group Pain threshold(s) Blank control group 17.78±2.85 Positive control group 19.34±2.97 Example 1 Group <![CDATA[24.51±3.02 ***,## ]]> Comparative Example 1 19.22±2.48 Comparative Example 2 19.67±2.63 Comparative Example 3 <![CDATA[20.64±3.05 * ]]> Comparative Example 4 <![CDATA[21.55±3.08 **,# ]]>

[0119] Note: Compared with the blank control group, * p<0.05, ** p<0.01, *** p<0.001; compared with the positive control group, ## p<0.01, # p<0.05.

[0120] In summary, the Chinese medicine composition of the present invention has the effects of promoting blood circulation, removing blood stasis, relaxing the intestine and relieving pain. It is mainly used to treat chest pain, heart pain, and cardiovascular diseases of qi stagnation and blood stasis type. It is particularly suitable for patients with coronary heart disease and angina pectoris with the above symptoms, and has broad clinical application prospects and economic value.

[0121] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition for treating cardiovascular disease of chest obstruction and blood stasis type, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-30 parts of salvia miltiorrhiza, 5-30 parts of curcuma, 5-30 parts of corydalis, 5-10 parts of ligusticum chuanxiong, 5-30 parts of notoginseng, 5-30 parts of pinellia, 5-30 parts of trichosanthes, 5-30 parts of immature bitter orange, 5-30 parts of allium macrostemon, and 1-20 parts of cassia twig.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-25 parts of salvia miltiorrhiza, 10-20 parts of curcuma, 10-20 parts of corydalis, 10-20 parts of ligusticum chuanxiong, 10-20 parts of notoginseng, 10-20 parts of pinellia, 10-20 parts of trichosanthes, 10-20 parts of immature bitter orange, 10-20 parts of allium macrostemon, and 5-10 parts of cassia twig.

3. The Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 21 parts of salvia miltiorrhiza, 18 parts of curcuma, 12 parts of corydalis, 15 parts of chuanxiong, 15 parts of panax notoginseng, 12 parts of pinellia, 15 parts of trichosanthes, 12 parts of immature bitter orange, 12 parts of allium macrostemon, and 9 parts of cinnamon twig.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: (1) Mix and ultrafinely grind Danshen, Curcuma, Chuanxiong, and Cinnamon to prepare mixed ultrafine powder; (2) adding water to decoct Corydalis yanhusuo, Panax notoginseng, Pinellia ternata, Trichosanthes kirilowii, Fructus aurantii, and Radix Allii macrostemonis; after the first decoction for 1-3 hours, filtering to obtain a primary filtrate; adding water to the filter residue and decoct for another 1-3 hours, filtering to obtain a secondary filtrate; combining the primary filtrate and the secondary filtrate, and concentrating to obtain a concentrated solution; (3) The mixed ultrafine powder obtained in step (1) is used as a base material, and the concentrated solution obtained in step (2) is sprayed into the mixed ultrafine powder, and the mixed powder is granulated and mixed to obtain the Chinese medicine composition granules.

5. The preparation method according to claim 4, characterized in that: In step (1), the fineness of the ultrafine powder is 100 mesh.

6. The preparation method according to claim 4 or claim 5, characterized in that: In step (2), the first decoction and the second decoction are both performed for 1 hour.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 6 in the preparation of a medicament for treating cardiovascular diseases of chest obstruction and blood stasis type.

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

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

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

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