Traditional Chinese medicine composition for eliminating phlegm and dispersing blood stasis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for eliminating phlegm and dispersing blood stasis and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from, by weight, 10-30 parts of rhizoma chuanxiong, 10-30 parts of cortex moutan, 10-30 parts of radix paeoniae rubra, 10-30 parts of radix salviae miltiorrhizae, 10-30 parts of radix acanthopanacis semticosi, 10-30 parts of fructus trichosanthis, 10-30 parts of allium macrostemon, 10-40 parts of raw radix astragali, 10-20 parts of rhizoma polygoni cuspidati and 10-20 parts of lotus leaves. The traditional Chinese medicine composition disclosed by the invention has the effects of simultaneously treating phlegm and blood stasis and eliminating phlegm and dispersing blood stasis, and is a proved recipe for years of clinical application for treating chest stuffiness and phlegm and blood stasis syndrome, clinical observation shows that the traditional Chinese medicine composition is stable in curative effect, few in adverse reaction and good in healing, and an effective traditional Chinese medicine preparation is provided for treating stable angina pectoris and phlegm and blood stasis syndrome. When the traditional Chinese medicine composition is prepared, volatile components are extracted at the same time, traditional Chinese medicine effect components of ligusticum wallichii and other medicines are fully reserved, and meanwhile the process is simple, high in universality and suitable for large-scale production.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a phlegm-removing and blood-stasis-dispelling Chinese medicine composition, a preparation method and application thereof. Background Art

[0002] Coronary heart disease is a common and frequently occurring disease worldwide, which seriously endangers human life. According to the severity of the disease, it is divided into stable coronary heart disease and unstable coronary heart disease. Stable angina pectoris (SAP), also known as exertional angina pectoris, is the most common type. It is a clinical syndrome of acute and temporary myocardial ischemia and hypoxia caused by increased myocardial load on the basis of fixed severe stenosis of the coronary arteries. The disease is relatively stable for a certain period of time, including the time of onset, nature, and duration. However, as the disease progresses, it may develop into major adverse cardiovascular events such as heart failure, leading to death. Studies have shown that asymptomatic patients with stable coronary heart disease have a higher long-term mortality rate. Drugs are the preferred option to control the progression of this disease, but 5-10% of patients still experience adverse cardiovascular events after simple Western medicine treatment. Therefore, how to prevent and treat SAP has been a hot topic in Chinese and Western medicine research in recent years.

[0003] Stable coronary heart disease belongs to the category of "chest pain" and "heart pain" in traditional Chinese medicine. It is a complex disease with both deficiency and excess. Deficiency of spleen and kidney is the internal cause and the root cause. Stasis and phlegm are the symptoms. They are the most common pathogenic factors of chest pain and participate in the progression of the entire disease. Phlegm comes from body fluid, and stasis comes from blood. Physiologically, "body fluid and blood have the same origin", and pathologically, "phlegm and stasis are the same disease". Although phlegm and stasis are two different substances and pathogenic factors, they have the same source but different flows. Deficiency of body fluid will cause stasis and phlegm; obstruction of body fluid circulation will cause stasis due to phlegm; and disorder of blood circulation will cause phlegm due to stasis. The two are intertwined, and phlegm and stasis are the same disease. Moreover, phlegm and stasis block the qi and blood, and the evil will block the pericardium for a long time. Therefore, the method of treating phlegm and stasis together and removing phlegm and removing blood stasis is an effective method to treat this disease. Simply treating stasis or phlegm cannot achieve the ideal effect. Summary of the invention

[0004] The first purpose of the present invention is to provide a Chinese medicine composition for removing phlegm and dissolving blood stasis, so as to overcome the problems of unsatisfactory effect on the treatment of coronary heart disease and limited drug selection in the prior art.

[0005] The second object of the present invention is to provide an application of a phlegm-removing and blood-stasis-dispelling Chinese medicine composition in the preparation of a medicine for treating coronary heart disease.

[0006] The third object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition.

[0007] In order to achieve the above-mentioned invention object, the technical solution adopted by the present invention includes:

[0008] A Chinese medicine composition for removing phlegm and dissolving blood stasis, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10-30 parts of chuanxiong, 10-30 parts of moutan bark, 10-30 parts of red peony root, 10-30 parts of salvia miltiorrhiza, 10-30 parts of acanthopanax senticosus, 10-30 parts of trichosanthes, 10-30 parts of allium macrostemon, 10-40 parts of raw astragalus, 10-20 parts of polygonum cuspidatum, and 10-20 parts of lotus leaf.

[0009] Preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Chuanxiong, 15 parts of Moutan Cortex, 10 parts of Red Peony Root, 10 parts of Salvia Miltiorrhiza, 15 parts of Acanthopanax Senticosus, 20 parts of Trichosanthes, 20 parts of Allium macrostemon, 30 parts of Raw Astragalus, 10 parts of Polygonum cuspidatum, and 10 parts of Lotus Leaf.

[0010] A method for preparing a Chinese medicine composition for removing phlegm and dissolving blood stasis comprises the following steps:

[0011] (1) Weigh the bulk drug according to claim 1 and set aside;

[0012] (2) After all the medicinal ingredients are soaked in water, they are heated and refluxed for extraction, and the volatile oil is collected at the same time. The filtrates are combined, concentrated, and precipitated with ethanol. The mixture is allowed to stand and filtered to recover the ethanol.

[0013] (3) Add volatile oil and stir evenly.

[0014] In the step (2), the soaking time is 0.5-2 hours, the extraction times are 1-3 times, and the extraction time is 1-2 hours.

[0015] A Chinese medicinal preparation for removing phlegm and dissolving blood stasis, wherein the extract obtained by the above preparation method is added with pharmaceutically acceptable auxiliary materials to prepare oral dosage forms such as mixture, oral liquid, tablet, capsule and granule.

[0016] The Chinese medicine composition is used in the preparation of medicine for treating coronary heart disease. The coronary heart disease is stable angina pectoris.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] The Chinese medicine composition of the present invention has the effects of treating phlegm and blood stasis at the same time, removing phlegm and removing blood stasis, and is a prescription for many years of clinical application in the treatment of chest pain with phlegm and blood stasis. Clinical observations show that the Chinese medicine composition group is significantly lower than the control group in the scores of angina attack frequency, duration, pain intensity, and nitroglycerin usage before treatment. And the scores of angina attack frequency and duration in the treatment group after treatment are significantly lower than those in the control group after treatment, and the differences are statistically significant; the scores of pain intensity and nitroglycerin usage are lower than those in the control group after treatment. Comparison of TCM syndrome scores: the chest pain, chest tightness, palpitations, limb heaviness, sticky stool, and purple lips of the two groups of patients after treatment are significantly lower than those before treatment. And the chest pain, palpitations, limb heaviness, sticky stool, and purple lips of the treatment group after treatment are lower than those in the control group; the chest tightness syndrome score is lower than that in the control group. The Chinese medicine composition has stable efficacy and few adverse reactions, and good recovery, providing an effective Chinese medicine preparation for the treatment of stable angina pectoris with phlegm and blood stasis. When preparing the Chinese medicine composition of the present invention, volatile components are extracted simultaneously, and the effective medicinal components of drugs such as Chuanxiong are fully retained. At the same time, the process is simple, the universality is strong, and it is suitable for large-scale production. DETAILED DESCRIPTION

[0019] The technical solution of the present invention will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0020] A Chinese medicine composition for removing phlegm and dissolving blood stasis, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10-30 parts of chuanxiong, 10-30 parts of moutan bark, 10-30 parts of red peony root, 10-30 parts of salvia miltiorrhiza, 10-30 parts of acanthopanax senticosus, 10-30 parts of trichosanthes, 10-30 parts of allium macrostemon, 10-40 parts of raw astragalus, 10-20 parts of polygonum cuspidatum, and 10-20 parts of lotus leaf.

[0021] Solution:

[0022] Chuanxiong: pungent, warm. Enters the liver, gallbladder and pericardium meridians. Efficacy: activating blood circulation and promoting qi, dispelling wind and relieving pain. Chuanxiong is a blood-qi medicine, good at activating blood circulation and promoting qi, can disperse blood stasis, and can also dredge qi and blood. It is one of the main medicines.

[0023] Peony bark: bitter, pungent, slightly cold. It enters the heart, liver and kidney meridians, and has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis. Its cooling blood effect can prevent blood stasis from turning into heat, while enhancing the blood stasis effect of the entire prescription.

[0024] Red Peony Root: bitter, slightly cold. Enters the Liver Channel. Effects: clears heat and cools blood, dissipates blood stasis and relieves pain. Used together with Peony Root to enhance the ability to cool blood and dissipate blood stasis.

[0025] Danshen: bitter, slightly cold, enters the heart and liver meridians, can promote blood circulation and regulate menstruation, remove blood stasis and relieve pain, relieve restlessness and calm the mind. The blood circulation effect of Danshen helps improve the blood circulation of the heart and blood vessels throughout the body.

[0026] Acanthopanax: sweet, slightly bitter, warm, enters the spleen, lung, heart, and kidney meridians, and has the functions of invigorating qi and strengthening spleen, nourishing kidney and calming mind, and promoting blood circulation and unblocking collaterals. Salvia miltiorrhiza promotes blood circulation and nourishes blood, while Acanthopanax invigorates qi. The combination of the two can nourish qi and blood, and promote blood circulation and unblock collaterals.

[0027] Trichosanthes: sweet, slightly bitter, cold in nature, enters the lung, stomach, and large intestine meridians, has the effects of clearing away heat and resolving phlegm, relieving chest tightness and dispersing stagnation, and moistening the intestines and promoting bowel movements.

[0028] Xiebai: pungent, bitter, warm, enters the heart, lung, stomach and large intestine meridians, has the effects of regulating qi, relieving chest tightness, promoting yang and dispersing nodules.

[0029] Raw Astragalus: sweet, slightly warm, enters the spleen and lung meridians, and has the effects of replenishing qi and raising yang, strengthening the body's defense system, promoting diuresis and reducing swelling, and removing toxins and promoting tissue regeneration. Qi is the leader of blood, and a large amount of Astragalus can replenish qi, promote blood circulation, enhance the effect of blood-activating and blood-stasis-removing drugs, and prevent excessive blood-activating drugs from damaging the vital energy.

[0030] Polygonum cuspidatum: bitter and cold, it enters the liver, gallbladder and lung meridians, and has the effects of removing dampness and jaundice, clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, resolving phlegm and relieving cough, and relieving constipation. It works synergistically with other blood-activating and blood-stasis-removing drugs to enhance the effect of removing blood stasis and unblocking meridians, and can also clear away heat, dampness and detoxify, so that pathological factors such as blood stasis and heat toxins can be eliminated.

[0031] Lotus leaf: bitter, neutral in nature, mainly enters the liver, spleen, and stomach meridians. It clears away heat and dampness, promotes the development of clear yang, cools blood and stops bleeding. In the prescription, it mainly plays the role of clearing turbidity and lowering lipids.

[0032] The Chuanxiong, Moutan Bark, Red Peony Root, Salvia miltiorrhiza, and Acanthopanax in the formula can promote blood circulation and dredge collaterals, remove blood stasis, regulate the Qi and make Qi and blood flow smoothly; the Trichosanthes and Allium macrostemon can resolve phlegm, relax the chest, and promote the flow of Qi to expand the chest yang. On the one hand, it treats the symptoms by resolving phlegm, and on the other hand, it treats the root cause by expanding the Yang Qi in the chest, making the meridians unobstructed, the Yang Qi can circulate through the meridians to circulate blood, and the heart can be nourished; it is supplemented with a large amount of raw Astragalus and a small amount of lotus leaf and Polygonum cuspidatum to invigorate the spleen and replenish Qi, raise Yang, and remove phlegm and resolve blood stasis.

[0033] Example 1

[0034] A traditional Chinese medicine composition is composed of the following raw materials: 15g of chuanxiong, 15g of moutan bark, 10g of red peony root, 10g of salvia miltiorrhiza, 15g of acanthopanax senticosus, 20g of trichosanthes, 20g of xiebai, 30g of raw astragalus, 10g of polygonum cuspidatum, and 10g of lotus leaf.

[0035] The preparation method comprises the following steps:

[0036] Weigh the medicinal materials according to the above dosage, soak all the medicinal materials in water for 60 minutes, heat and boil for 1 hour, filter, add water to the residue and continue to boil for 30 minutes, combine the two filtrates, and you have it.

[0037] Example 2

[0038] A traditional Chinese medicine composition is composed of the following raw materials: 30g of chuanxiong, 15g of moutan bark, 10g of red peony root, 25g of salvia miltiorrhiza, 15g of acanthopanax senticosus, 25g of trichosanthes, 25g of allium macrostemon, 40g of raw astragalus, 10g of polygonum cuspidatum, and 15g of lotus leaf.

[0039] The preparation method comprises the following steps:

[0040] Weigh the raw medicinal materials according to the above ratio, soak all the medicinal ingredients in water for 30 minutes, heat and boil for 1 hour, filter, add water to the residue and continue to boil for 1 hour, combine the two filtrates, and you have it.

[0041] Example 3

[0042] A traditional Chinese medicine composition is composed of the following raw materials: 10g of chuanxiong, 20g of moutan bark, 15g of red peony root, 15g of salvia miltiorrhiza, 10g of acanthopanax senticosus, 15g of trichosanthes, 15g of allium macrostemon, 25g of raw astragalus, 15g of polygonum cuspidatum, and 20g of lotus leaf.

[0043] The preparation method comprises the following steps:

[0044] Weigh the raw medicinal materials according to the above ratio, soak all the medicinal ingredients in water for 30 minutes, heat and boil for 1 hour, filter, add water to the residue and continue to boil for 1 hour, combine the two filtrates, and you have it.

[0045] Example 4

[0046] A Chinese medicine oral liquid is composed of the following raw materials: 15kg of Chuanxiong, 15kg of Moutan Cortex, 10kg of Red Peony Root, 10kg of Salvia Miltiorrhiza, 15kg of Acanthopanax Senticosus, 20kg of Trichosanthes, 20kg of Allium Macrostemon, 30kg of Raw Astragalus, 10kg of Polygonum Cuspidati, and 10kg of Lotus Leaf.

[0047] After all the medicinal flavors of the above raw materials are soaked in water, they are heated and refluxed for extraction twice, each time for 2 hours, and volatile oil is collected at the same time. The filtrates are combined and concentrated to a relative density of 1.09 (50°C), ethanol is added to make the alcohol content of 65% alcohol precipitation, and the mixture is allowed to stand and filtered, and the ethanol is recovered until there is no alcohol taste, and water is added to a relative density of 1.05-1.09 (50°C); the volatile oil is added, stirred evenly, packaged, and sterilized to obtain the product.

[0048] Example 5

[0049] A Chinese medicine capsule is composed of the following raw materials: 15kg of Chuanxiong, 15kg of Moutan Cortex, 10kg of Red Peony Root, 10kg of Salvia Miltiorrhiza, 15kg of Acanthopanax Senticosus, 20kg of Trichosanthes, 20kg of Allium Macrostemon, 30kg of Raw Astragalus, 10kg of Polygonum Cuspidati, and 10kg of Lotus Leaf.

[0050] After all the medicinal flavors of the above raw materials are soaked in water, heated and refluxed for extraction 3 times, each time for 1 hour, and volatile oil is collected at the same time. The filtrates are combined and concentrated to a relative density of 1.09 (50°C), ethanol is added to make the alcohol content of 65% alcohol precipitation, and the mixture is allowed to stand and filtered. The ethanol is recovered until there is no alcohol taste, dextrin is added, 95% ethanol is used for granulation, and the mixture is dried. The volatile oil is sprayed and the capsule is filled.

[0051] Experimental example

[0052] 1. Objects and methods

[0053] 1.1 Research subjects and groups

[0054] A total of 74 patients with stable angina pectoris due to coronary heart disease and phlegm and blood stasis syndrome admitted to the outpatient department of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from September 2023 to May 2024 were selected as research subjects. According to the order of visit, the patients were randomly divided into a control group and a treatment group using a random number table method, with 37 cases in each group.

[0055] 1.2 Diagnostic criteria

[0056] 1.2.1 Western medicine diagnostic criteria

[0057] According to the diagnostic guidelines for angina pectoris in coronary heart disease developed by the American College of Cardiology and the American Heart Association (ACC / AHA), and with reference to the "2007 Diagnosis and Treatment Guidelines for Chronic Stable Angina Pectoris in China", the Western medicine diagnostic criteria for patients with stable angina pectoris in coronary heart disease are developed. The diagnosis can be made if any one or more of the following is met: ① A clear history of old myocardial infarction. ② Coronary angiography or coronary artery computed tomography angiography (CTA) examination showed that the diameter of the lumen of at least one major branch of the coronary artery was stenotic by ≥50%. ③ Coronary artery revascularization [coronary artery intervention (PCI) or coronary artery bypass grafting (CABG)] treatment has been received.

[0058] The Canadian Cardiovascular Society (CCS) classifies the severity of angina pectoris as follows: Grade I: No symptoms during daily activities, but angina pectoris may be induced by strenuous physical activities that are heavier than daily activities, such as jogging on flat ground or carrying heavy objects to the third floor or uphill. Grade II: Daily physical activities are slightly restricted, such as walking 300-400m at a normal speed, going up the third floor or uphill, which may induce angina pectoris. Grade III: Daily physical activities are significantly restricted, such as walking 100-200m at a normal speed, going up the second floor or up a small slope, which may induce angina pectoris. Grade IV: Mild physical activities may induce angina symptoms even when the patient is at rest.

[0059] 1.2.2 TCM diagnostic criteria

[0060] The diagnosis criteria for chest pain and phlegm and blood stasis type in the "Guidelines for Diagnosis and Treatment of Stable Angina Pectoris in Coronary Heart Disease" and the "Guidelines for Clinical Research of New Chinese Medicines" were formulated by the Cardiovascular Disease Branch of the Chinese Association of Traditional Chinese Medicine.

[0061] 1.3 Inclusion criteria

[0062] Age 30-80 years old, regardless of gender; meet the Western medical diagnosis criteria for coronary heart disease and angina severity grade I-III; meet the TCM diagnosis criteria for chest pain, and TCM syndrome differentiation is phlegm and blood stasis syndrome; voluntarily participate in this trial and sign the informed consent. 1.4 Exclusion criteria:

[0063] ① Patients with unstable angina pectoris, severe arrhythmia, rheumatic heart disease, cor pulmonale, and severe cardiopulmonary insufficiency due to coronary heart disease; ② Patients with stage 3 hypertension and hypertensive encephalopathy; ③ Patients with severe hemorrhagic diseases, acute infections, respiratory failure, and liver and kidney dysfunction; ④ Patients with acute cerebral infarction and other craniocerebral trauma or organic brain lesions within the past 3 months; ⑤ Patients taking Chinese herbal medicines or Chinese patent medicines with similar effects during treatment; ⑥ Women who are planning to become pregnant or are pregnant or breastfeeding; ⑦ Patients with a history of alcoholism, drug abuse, and mental illness.

[0064] 1.5 Elimination and termination criteria

[0065] ① Those who did not meet the criteria and were mistakenly included; ② Patients who are allergic to the study drugs (including their ingredients); ③ Patients who do not cooperate with examinations, treatments, and take medications on time during treatment; ④ Due to the patient's own use of banned drugs during the clinical research, this study was unable to conduct effectiveness and safety evaluation.

[0066] 1.6 Treatment

[0067] Both groups were given health education and were guided to eat a low-salt and low-fat diet, quit smoking, exercise moderately, and control blood sugar and blood pressure.

[0068] 1.6.1 Control group

[0069] With reference to the 2007 "Guidelines for the Diagnosis and Treatment of Chronic Stable Angina", standardized Western medicine treatment was carried out according to the condition of the patient. The main measures included lipid-lowering drugs, antiplatelet drugs, nitrate preparations, beta-blockers, calcium ion blockers and other conventional drug treatments. The course of treatment was 12 weeks.

[0070] 1.6.2 Treatment groups

[0071] The control group was given the decoction of Example 1. The decoction room of our hospital decocted and packaged the decoction (each dose of Chinese medicine was decocted and packaged into 2 bags, each bag was 200 mL), 2 bags per day, warmed and taken twice a day, morning and evening. The course of treatment was 12 weeks.

[0072] 1.7 Observation indicators

[0073] 1.7.1 Evaluation of the efficacy of angina pectoris symptoms

[0074] The efficacy was evaluated with reference to the "Guidelines for Clinical Research on New Chinese Medicines for the Treatment of Angina Pectoris in Coronary Heart Disease". (1) Grade I: Significant effect: chest tightness and pain symptoms do not appear or basically do not appear; effective: the duration, frequency and severity of chest tightness and pain attacks are significantly reduced compared with before; ineffective: the symptoms of chest tightness and pain are almost unchanged compared with before treatment; aggravated: the duration, frequency and severity of chest tightness and pain attacks are aggravated compared with before. (2) Grade II: Significant effect: chest tightness and pain symptoms do not appear or basically do not appear; effective: chest tightness and pain are reduced to Grade I; ineffective: the symptoms of chest tightness and pain are almost unchanged compared with before treatment; aggravated: the duration, frequency and severity of chest tightness and pain attacks are aggravated compared with before. (3) Grade III: Significant effect: chest tightness and pain symptoms do not appear or basically do not appear; effective: chest tightness and pain are reduced to Grade II; ineffective: the symptoms of chest tightness and pain are almost unchanged compared with before treatment; aggravated: the duration, frequency and severity of chest tightness and pain attacks are aggravated compared with before.

[0075] 1.7.2 Angina pectoris efficacy score

[0076] The evaluation of angina pectoris efficacy score was carried out with reference to the "Criteria for Evaluating the Efficacy of Angina Pectoris and Electrocardiogram in Coronary Heart Disease" and related studies, including the score of the number of angina pectoris attacks, the score of duration, the score of pain intensity, and the score of nitroglycerin usage. ① Score of the number of angina pectoris attacks: 0 points: no attack; 2 points: the number of attacks ≤6 times / week; 4 points: the number of attacks is 1-3 times / d; 6 points: the number of attacks is ≥4 times / d. ② Duration score: 0 points: no attack; 2 points: the duration is ≤5min / time; 4 points: the duration is 5-10min / time; 6 points: the duration is ≥10min / time; ③ Pain intensity score: 0 points: no attack; 2 points: rest can relieve the attack, but it does not affect daily activities; 4 points: medication is required to relieve the attack, and normal activities can be continued; 6 points: frequent attacks, which affect normal life and activities. ④ Score of nitroglycerin usage: 0 points: no attack; 2 points: 1-4 tablets per week; 4 points: 5-9 tablets per week; 6 points: ≥10 tablets per week. The changes in the scores of angina attack frequency, duration, pain intensity and nitroglycerin usage were observed in the two groups of patients before and after treatment.

[0077] 1.7.3 TCM Syndrome Score Evaluation Criteria

[0078] A TCM syndrome scoring scale was developed with reference to the Guiding Principles for Clinical Research of New Chinese Medicines, including chest pain, chest tightness, palpitations, heavy limbs, sticky stools, and dark purple lips. Each symptom was divided into 4 levels according to its severity: none, mild, moderate, and severe, with scores of 0, 2, 4, and 6, respectively. The changes in the TCM syndrome scores of the two groups of patients before and after treatment were observed.

[0079] 1.7.4 Safety evaluation

[0080] The adverse events during treatment as well as the changes in blood, urine, stool routine tests, liver function, kidney function, electrocardiogram and other safety indicators were observed in the two groups of patients.

[0081] 1.8 Statistical methods

[0082] SPSS 22.0 software was used for data analysis. Measurement data were expressed as mean ± standard deviation (x ± s), and paired t and independent sample t tests were used for intra-group and inter-group comparisons, respectively; count data were expressed as cases (%), and χ test was used for inter-group comparisons. 2 P<0.05 was considered statistically significant.

[0083] 2. Results

[0084] 2.1 Comparison of dropout and baseline data between the two groups

[0085] During the study, 2 patients dropped out of the control group and 2 patients dropped out of the treatment group, and 35 patients completed the study. As shown in Table 1, there was no significant difference in the general data of the patients who completed the study between the two groups (P>0.05), indicating that the baseline characteristics of the two groups were basically the same and comparable.

[0086] Table 1 Comparison of general data between the two groups

[0087]

[0088] 2.2 Comparison of the efficacy of angina pectoris symptoms before and after treatment between the two groups

[0089] According to the angina pectoris classification, the efficacy of angina pectoris symptoms in the two groups of patients before and after treatment was compared. As shown in Table 2, the treatment group was better than the control group, and the difference was statistically significant (P<0.05).

[0090] Table 2 Comparison of the efficacy of angina pectoris symptoms before and after treatment between the two groups of patients

[0091]

[0092] 2.3 Comparison of angina pectoris efficacy scores between the two groups before and after treatment

[0093] As shown in Table 3, before treatment, there were no significant differences in the scores of angina attack frequency, duration, pain intensity, and nitroglycerin usage between the two groups (P>0.05), which showed comparability. Compared with before treatment, the scores of angina attack frequency, duration, pain intensity, and nitroglycerin usage in the two groups after treatment were significantly lower than those before treatment (P<0.01). The scores of angina attack frequency and duration in the treatment group after treatment were significantly lower than those in the control group after treatment, and the differences were statistically significant (P<0.01); the scores of pain intensity and nitroglycerin usage were lower than those in the control group after treatment, and the differences were statistically significant (P<0.05).

[0094] Table 3 Comparison of angina pectoris efficacy scores between the two groups of patients before and after treatment (x±s, points)

[0095]

[0096] Note: Compared with before treatment, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01

[0097] 2.4 Comparison of TCM syndrome scores between the two groups before and after treatment

[0098] As shown in Table 4, before treatment, there was no significant difference in the chest pain, chest tightness, palpitations, limb heaviness, sticky stool, and purple lips between the two groups (P>0.05), which was comparable. Compared with before treatment, the chest pain, chest tightness, palpitations, limb heaviness, sticky stool, and purple lips of the two groups after treatment were significantly lower than those before treatment (P<0.01). Moreover, the chest pain, palpitations, limb heaviness, sticky stool, and purple lips of the treatment group after treatment were lower than those of the control group, and the differences were statistically significant (P<0.05); the chest tightness symptom score was lower than that of the control group, and the difference was statistically significant (P<0.01).

[0099] Table 4 Comparison of TCM syndrome scores between the two groups of patients before and after treatment ( point)

[0100]

[0101] Note: Compared with before treatment, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01

[0102] 2.5 Comparison of the incidence of adverse events between the two groups

[0103] During the treatment, there were no significant changes in blood, urine, stool routine and safety indicators such as liver function, kidney function, and electrocardiogram in the two groups of patients. In the control group, 1 patient had headache, and the incidence of adverse events was 2.86%; in the treatment group, 1 patient had dizziness and 1 patient had gastrointestinal reaction, and the incidence of adverse events was 5.71%. There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05), and the adverse reactions of both groups of patients improved after rest, without special treatment.

Claims

1. A Chinese medicine composition for removing phlegm and dispelling blood stasis, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10-30 parts of chuanxiong, 10-30 parts of moutan bark, 10-30 parts of red peony root, 10-30 parts of salvia miltiorrhiza, 10-30 parts of acanthopanax senticosus, 10-30 parts of trichosanthes, 10-30 parts of allium macrostemon, 10-40 parts of raw astragalus, 10-20 parts of polygonum cuspidatum, and 10-20 parts of lotus leaf.

2. The Chinese medicine composition according to claim 1, characterized in that: The medicine is composed of the following raw materials in parts by weight: 15 parts of chuanxiong, 15 parts of moutan bark, 10 parts of red peony root, 10 parts of salvia miltiorrhiza, 15 parts of acanthopanax senticosus, 20 parts of trichosanthes, 20 parts of xiebai, 30 parts of raw astragalus, 10 parts of polygonum cuspidatum, and 10 parts of lotus leaf.

3. A method for preparing a Chinese medicine composition for removing phlegm and dissolving blood stasis, characterized in that: The following steps are involved: (1) Weigh the bulk drug according to claim 1 and set aside; (2) After all the medicinal ingredients are soaked in water, they are heated and refluxed for extraction, and the volatile oil is collected at the same time. The filtrates are combined, concentrated, precipitated with ethanol, allowed to stand and filtered, and the ethanol is recovered; (3) Add volatile oil and stir evenly.

4. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: In the step (2), the soaking time is 0.5-2 hours, the extraction times are 1-3 times, and the extraction time is 1-2 hours.

5. A Chinese medicine preparation for removing phlegm and dissolving blood stasis, characterized in that: The extract obtained by the preparation method of claim 3 is added with pharmaceutically acceptable excipients to prepare oral dosage forms such as mixtures, oral liquids, tablets, capsules, and granules.

6. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of medicines for treating coronary heart disease.

7. The use according to claim 8, characterized in that: The coronary heart disease is stable angina pectoris.

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