Kidney-tonifying and spleen-tonifying traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention discloses a kidney-tonifying and spleen-tonifying traditional Chinese medicine composition as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10 to 40 parts of roasted turtle shell, 10 to 30 parts of herba taxilli, 10 to 20 parts of cortex eucommiae, 10 to 30 parts of semen cuscutae, 10 to 30 parts of herba cistanche, 10 to 30 parts of radix codonopsis, 10 to 30 parts of poria cocos, 10 to 30 parts of rhizoma polygoni cuspidati and 10 to 30 parts of rhizoma chuanxiong. The traditional Chinese medicine composition disclosed by the invention has the effects of tonifying kidney and spleen, dissipating blood stasis and relieving pain, and softening hardness to dissipate stagnation, is a proved recipe for clinical application for many years, is stable in curative effect, few in adverse reaction and good in healing, and provides an effective traditional Chinese medicine preparation for treating stable angina pectoris. During preparation of the traditional Chinese medicine composition, monarch drugs are pulverized and used as medicines, other medicines are extracted and concentrated, medicinal components are fully reserved, and the traditional Chinese medicine composition is simple in process, 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 kidney-tonifying and spleen-strengthening 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] According to traditional Chinese medicine, stable coronary heart disease belongs to the category of "chest pain" and "heart pain". It is a complex disease with both deficiency and excess. Among them, spleen and kidney deficiency is the root cause. Patients with this disease have been old and weak for many years. Long-term illness leads to spleen and kidney deficiency and obstruction of chest yang. The spleen is the foundation of acquired constitution and the kidney is the foundation of congenital constitution. Long-term illness leads to spleen deficiency and dysfunction of transportation and transformation, which leads to insufficient kidney essence over time; insufficient kidney yang cannot warm spleen yang, which leads to spleen deficiency. Deficiency of the two organs leads to dysfunction of water transportation and transformation, poor circulation of qi and blood, and weak chest yang, which causes flooding and obstruction of heart meridians, resulting in this disease. Therefore, the method of tonifying the kidney and strengthening the spleen is used clinically as the basic method to treat this disease. Summary of the invention

[0004] The first purpose of the present invention is to provide a Chinese medicine composition for tonifying the kidney and strengthening the spleen, so as to overcome the problems in the prior art that the treatment effect of western medicine alone is not ideal and the drug selection is limited.

[0005] The second object of the present invention is to provide a Chinese medicine composition for tonifying the kidney and strengthening the spleen for use in preparing a medicine for treating stable angina pectoris.

[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 traditional Chinese medicine composition, which is composed of the following raw materials in parts by weight: 10-40 parts of roasted turtle shell, 10-30 parts of mistletoe, 10-20 parts of eucommia bark, 10-30 parts of dodder seeds, 10-30 parts of cistanche deserticola, 10-30 parts of codonopsis pilosula, 10-30 parts of tuckahoe, 10-30 parts of polygonum cuspidatum, and 10-30 parts of ligusticum chuanxiong.

[0009] Preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 30 parts of roasted turtle shell, 15 parts of mistletoe, 15 parts of eucommia bark, 15 parts of dodder seeds, 10 parts of cistanche, 10 parts of codonopsis pilosula, 10 parts of poria, 10 parts of polygonum cuspidatum, and 15 parts of chuanxiong.

[0010] A method for preparing a Chinese medicine composition comprises the following steps:

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

[0012] (2) Crush the roasted turtle shell, sieve and set aside;

[0013] (3) soaking the remaining medicinal ingredients in water, heating and refluxing for extraction, filtering to obtain a filtrate, concentrating it, mixing it with the roasted turtle shell powder in step (2), drying it, and granulating it.

[0014] The roasted turtle shell is roasted turtle shell with vinegar.

[0015] The roasted turtle shell is crushed and passed through a 100-mesh sieve.

[0016] In the step (3), the soaking time is 1-2 hours, the extraction times are 1-3 times, and the extraction time is 0.5-2 hours.

[0017] A Chinese medicine preparation, wherein the dry particles obtained by the above preparation method are added with pharmaceutically acceptable auxiliary materials to be made into oral dosage forms such as tablets, capsules and granules.

[0018] The Chinese medicine composition is used in the preparation of medicine for treating coronary heart disease. The coronary heart disease is stable angina pectoris.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The Chinese medicine composition of the present invention has the effects of invigorating the kidney and spleen, dispersing blood stasis and relieving pain, softening and dispersing hard masses, and is a proven prescription for many years of clinical application. Clinical observations show that the number of angina attacks, duration, pain degree and nitroglycerin usage in the group using the Chinese medicine composition are reduced to varying degrees compared with the control group; after treatment, the chest pain, chest tightness, palpitations, poor appetite (spleen deficiency), and soreness of the waist and knees (kidney deficiency) of the patient are significantly reduced compared with before treatment; the clinical efficacy of the treatment group is significantly better than that of the control group. The Chinese medicine composition has stable efficacy and few adverse reactions, and the recovery is good, which provides an effective Chinese medicine preparation for the treatment of stable angina pectoris. When preparing the Chinese medicine composition of the present invention, the main medicine is powdered for medicine, and other medicinal flavors are extracted and concentrated, so that the effective components are fully retained, the process is simple, the universality is strong, and it is suitable for large-scale production. DETAILED DESCRIPTION

[0021] 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.

[0022] The traditional Chinese medicine composition of the present invention is composed of the following raw materials in parts by weight: 10-40 parts of roasted turtle shell, 10-30 parts of mistletoe, 10-20 parts of eucommia bark, 10-30 parts of dodder seeds, 10-30 parts of cistanche deserticola, 10-30 parts of codonopsis pilosula, 10-30 parts of tuckahoe, 10-30 parts of polygonum cuspidatum and 10-30 parts of chuanxiong.

[0023] Solution:

[0024] Roasted turtle shell: Turtle shell is the carapace of the turtle Trionyx sinensis Wiegmann, a member of the family Testudinidae. It is salty and slightly cold, and it enters the liver and kidneys, nourishes yin and suppresses yang, softens and disperses stagnation, and relieves fever and eliminates steam. As the main drug, its softening and dispersing stagnation function can dissipate pathological products such as blood stasis and phlegm in patients with coronary heart disease (for example, coronary atherosclerotic plaques in patients with coronary heart disease may be related to blood stasis and phlegm in traditional Chinese medicine theory).

[0025] Mulberry: Mulberry is the dried leaves, stems and branches of Taxillus chinensis (DC.) Danser. of the Parasitic family. It is bitter, sweet and neutral. It enters the liver and kidney meridians. It can dispel rheumatism, nourish the liver and kidney, strengthen the tendons and bones, and stabilize the fetus. It assists the main drug and enhances the effect of nourishing the liver and kidney.

[0026] Eucommia: This product is the dried bark of Eucommia ulmoide Oliv., a plant of the Eucommia family. It is sweet and warm, and it enters the liver and kidney. It nourishes the liver and kidney, strengthens the tendons and bones, and stabilizes the fetus. Eucommia helps the main medicine to strengthen the liver and kidney, strengthens the tendons and bones by nourishing the liver and kidney, and provides the body with sufficient qi and blood nourishment, so that qi and blood can flow better to important organs such as the heart.

[0027] Cuscuta: This product is the dried mature seeds of Cuscuta australis R.Br. or Cuscuta chinensis Lam., a plant of the Convolvulaceae family. It is pungent, sweet and neutral. It enters the liver, kidney and spleen meridians. It nourishes the liver and kidney, consolidates the essence and reduces urine, stabilizes the fetus, improves eyesight and stops diarrhea; it can be used externally to eliminate wind and remove spots. Cuscuta plays a key role in nourishing the kidney and essence among the minister drugs, and together with other minister drugs, it assists the monarch drug in nourishing the liver and kidney. At the same time, its meridians involve the spleen meridian, and it also has a certain nourishing effect on the spleen and stomach, which helps the generation and transportation of qi and blood, provides more sufficient qi and blood support for the heart, and improves the qi and blood deficiency of patients with coronary heart disease.

[0028] Cistanche deserticola: This product is the dried fleshy stem with scale leaves of Cistanche deserticola YCMa, a plant of the Orobanchaceae family. It is sweet, salty, and warm, and it is good for the kidney and large intestine. It nourishes kidney yang, benefits essence and blood, and moistens the intestines and promotes bowel movements. Cistanche deserticola assists the main drug and other auxiliary drugs to enhance the effect of nourishing kidney yang. For patients with coronary heart disease, sufficient kidney yang helps warm up and promote the circulation of qi and blood, so that the heart can get sufficient blood supply. At the same time, its function of benefiting essence and blood is beneficial to nourishing the internal organs, including the heart, and is helpful to improve myocardial nutrition and other conditions.

[0029] Codonopsis pilosula: This product is the dried root of Codonopsis pilosula (Franch.) Nannf., a plant of the Campanulaceae family. It is sweet and mild in nature, and enters the spleen and lungs, replenishes qi, promotes the production of body fluid, and nourishes blood. As an adjuvant, it can enhance the function of the spleen and stomach, and promote the production of qi and blood by strengthening the spleen.

[0030] Poria: This product is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It is sweet, light, and neutral in nature. It enters the heart, lung, spleen, and kidney meridians, promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. The spleen-strengthening effect of Poria can cooperate with Codonopsis pilosula to enhance the transport and transformation function of the spleen and stomach and promote water and dampness metabolism.

[0031] Polygonum cuspidatum: This product is the rhizome and root of Polygonum cuspidatum Sieb.et Zucc., a herbaceous plant of the Polygonaceae family. It tastes bitter and slightly cold. It enters the liver, gallbladder, and lung meridians. It has the effects of removing dampness and jaundice, clearing away heat and detoxifying, dispersing blood stasis and relieving pain, and relieving cough and phlegm. It can remove pathological factors such as dampness, heat, and blood stasis in the body, reduce the burden on the heart, and its blood stasis and analgesic effects can also help improve symptoms such as angina pectoris in patients with coronary heart disease, and assist other drug treatments.

[0032] Chuanxiong: This product is the dried rhizome of the plant Chuanxiong Hort. of the Apiaceae family. It is pungent and warm. It is good for the liver, gallbladder and pericardium. It can promote blood circulation and qi, dispel wind and relieve pain. As a guiding drug, Chuanxiong can guide other drugs to the diseased area, especially the heart. At the same time, its function of promoting blood circulation and qi can improve the blood circulation of the heart and make the qi and blood flow smoothly in the body.

[0033] In the formula, turtle shell is the main medicine, which nourishes the liver and kidneys, softens and disperses nodules; mistletoe, eucommia, dodder seed, and cistanche are the auxiliary medicines, which regulate and nourish the liver and kidneys, replenish the essence and fill the marrow, and enhance the function of turtle shell in softening and dispersing nodules; it is assisted by codonopsis, poria, and polygonum cuspidatum, which can strengthen the spleen and eliminate dampness, clear phlegm and disperse nodules. At the same time, strengthening the spleen also helps to nourish the kidneys. Together, they can make the spleen and kidneys strong; Chuanxiong is the guiding medicine, which can promote blood circulation and dredge collaterals, remove blood stasis, regulate qi, and make qi and blood flow smoothly, and the meridians of the five internal organs smooth, thereby achieving the effect of preventing and treating stable angina pectoris of coronary heart disease.

[0034] Example 1

[0035] A traditional Chinese medicine composition is composed of the following raw materials: 30g of roasted turtle shell, 15g of parasitic plant, 15g of eucommia bark, 15g of dodder seed, 10g of cistanche, 10g of codonopsis pilosula, 10g of tuckahoe, 10g of polygonum cuspidatum, and 15g of chuanxiong.

[0036] The preparation method comprises the following steps:

[0037] Weigh the raw medicinal materials according to the above ratio, take the roasted turtle shell and decocted for 1 hour, soak the remaining medicinal ingredients in water for 30 minutes, pour in the roasted turtle shell and the decocted soup, 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.

[0038] Example 2

[0039] A traditional Chinese medicine composition is composed of the following raw materials: 35g of roasted turtle shell, 25g of parasitic plant, 20g of eucommia bark, 15g of dodder seed, 15g of cistanche deserticola, 20g of codonopsis pilosula, 10g of tuckahoe, 10g of polygonum cuspidatum, and 20g of ligusticum chuanxiong.

[0040] The preparation method comprises the following steps:

[0041] Weigh the raw medicinal materials according to the above ratio, take the roasted turtle shell and decocted for 1 hour first, soak the remaining medicinal ingredients in 10 times the amount of water for 1 hour, pour in the roasted turtle shell and the decocted decoction, heat and reflux to extract for 1.5 hours, filter, add 8 times the amount of water to the residue and continue to reflux and extract for 30 minutes, combine the two filtrates, and concentrate to obtain the product.

[0042] Example 3

[0043] A traditional Chinese medicine composition is composed of the following raw materials: 25g of roasted turtle shell, 25g of mistletoe, 20g of eucommia bark, 10g of dodder seed, 10g of cistanche deserticola, 25g of codonopsis pilosula, 15g of tuckahoe, 15g of polygonum cuspidatum, and 25g of chuanxiong.

[0044] The preparation method comprises the following steps:

[0045] Weigh the raw medicinal materials according to the above ratio, take the roasted turtle shell and decocted for 1.5 hours, soak the remaining medicinal ingredients in water for 30 minutes, pour in the roasted turtle shell and the decocted soup, heat and boil for 1.5 hours, filter, add water to the residue and continue to boil for 30 minutes, combine the two filtrates, and you have it.

[0046] Example 4

[0047] A traditional Chinese medicine preparation is composed of the following raw materials: 30kg of roasted turtle shell, 15kg of parasitic plant, 15kg of eucommia bark, 15kg of dodder seed, 10kg of cistanche, 10kg of codonopsis pilosula, 10kg of tuckahoe, 10kg of polygonum cuspidatum and 15kg of chuanxiong.

[0048] Among the above raw materials, the roasted turtle shell is crushed and passed through a 100-mesh sieve. The remaining raw materials are soaked in water for 1 hour and decocted three times, each time for 1.5 hours. The filtrates are combined and concentrated. The roasted turtle shell powder and dextrin are added, mixed evenly, vacuum-dried, crushed and granulated with ethanol, lubricants such as magnesium stearate are added, and tablets are obtained.

[0049] Experimental example

[0050] 1. Objects and methods

[0051] 1.1 Research subjects and groups

[0052] A total of 70 patients with stable angina pectoris due to coronary heart disease and kidney and spleen deficiency syndrome admitted to the outpatient and inpatient departments of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from September 2023 to February 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 35 cases in each group.

[0053] 1.2 Diagnostic criteria

[0054] 1.2.1 Western medicine diagnostic criteria

[0055] 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.

[0056] 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.

[0057] 1.2.2 TCM diagnostic criteria

[0058] Refer to the diagnostic criteria for chest pain in the "Guidelines for the Diagnosis and Treatment of Stable Angina Pectoris in Coronary Heart Disease" and the "Guidelines for Clinical Research of New Chinese Medicines" formulated by the Cardiovascular Disease Branch of the Chinese Association of Traditional Chinese Medicine; the syndrome differentiation standards refer to the "Standards for Syndrome Differentiation of Coronary Heart Disease in Traditional Chinese Medicine" revised by the Cardiovascular Branch of the Chinese Association of Integrated Traditional Chinese and Western Medicine in 1991 and the national standard of the People's Republic of China "Terminology for Clinical Diagnosis and Treatment of Traditional Chinese Medicine - Syndrome Part".

[0059] 1.3 Inclusion criteria

[0060] Applicants aged 30-80 years, regardless of gender; met the Western medical diagnostic criteria for coronary heart disease and had angina pectoris severity graded I-III; met the TCM diagnostic criteria for chest pain and had kidney and spleen deficiency syndrome according to TCM diagnosis; voluntarily participated in this trial and signed the informed consent form.

[0061] 1.4 Exclusion criteria

[0062] ① Patients with concurrent acute myocardial infarction, severe arrhythmia, rheumatic heart disease, cor pulmonale, heart failure (heart function grade 3-4), pacemaker or heart transplant; ② Patients with concurrent grade 3 hypertension and hypertensive encephalopathy; ③ Patients with concurrent severe hemorrhagic diseases, acute infection, respiratory failure, 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.

[0063] 1.5 Elimination and termination criteria:

[0064] ① Patients who did not meet the criteria and were mistakenly included; ② Patients who were allergic to the study drugs (including their formulation ingredients); ③ Patients who did not cooperate with examinations, treatments, or take medications on time during treatment;

[0065] 1.6 Treatment

[0066] 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.

[0067] 1.6.1 Control group

[0068] Conventional western medicine treatment was given, and the main measures included lipid-lowering drugs, antiplatelet drugs, nitrate preparations, beta-blockers, calcium ion antagonists and other conventional drug treatments, with a course of 12 weeks.

[0069] 1.6.2 Treatment groups

[0070] 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.

[0071] 1.7 Observation indicators

[0072] 1.7.1 Evaluation of the efficacy of angina pectoris symptoms

[0073] 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.

[0074] 1.7.2 Angina pectoris efficacy score

[0075] 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.

[0076] 1.7.3 TCM Syndrome Efficacy

[0077] The TCM syndrome scoring scale was developed with reference to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)", the "Standards for TCM Syndrome Differentiation of Coronary Heart Disease" revised by the Cardiovascular Branch of the Chinese Association of Integrated Traditional Chinese and Western Medicine in 1991, and the National Standard of the People's Republic of China "Terms of Clinical Diagnosis and Treatment of TCM - Syndrome Part", which specifically includes chest pain, chest tightness, palpitations, poor appetite (spleen deficiency), soreness of waist and knees (kidney deficiency), etc. Each symptom is divided into 4 levels according to its severity, namely none, mild, moderate, and severe, and is scored as 0, 2, 4, and 6 points respectively. The changes in the TCM syndrome scores of the two groups of patients before and after treatment were observed.

[0078] 1.7.4 Safety evaluation

[0079] 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.

[0080] 1.8 Statistical methods

[0081] 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.

[0082] 2. Results

[0083] 2.1 Comparison of dropout and baseline data between the two groups

[0084] During the study, 1 patient dropped out in the control group and 2 patients dropped out in the treatment group, and 34 and 33 patients completed the study, respectively. 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 of patients were basically the same and comparable.

[0085] Table 1 Comparison of general data between the two groups

[0086]

[0087] 2.2 Comparison of the efficacy of angina pectoris symptoms before and after treatment between the two groups

[0088] 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).

[0089] Table 2 Comparison of the efficacy of angina pectoris symptoms before and after treatment between the two groups of patients

[0090]

[0091] 2.3 Comparison of angina pectoris efficacy scores between the two groups before and after treatment

[0092] As shown in Table 2, 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. After treatment, the scores of angina attack frequency, duration, pain intensity, and nitroglycerin usage in the two groups were significantly lower than those before treatment (P<0.01). The scores of angina attack frequency and duration in the treatment group 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).

[0093] Table 2 Comparison of angina pectoris efficacy scores between the two groups of patients before and after treatment (x±s, points)

[0094]

[0095] Note: Compared with before treatment, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01

[0096] 2.4 Comparison of TCM syndrome scores between the two groups before and after treatment

[0097] As shown in Table 3, before treatment, there was no significant difference in the symptom scores of chest pain, chest tightness, palpitations, poor appetite, and soreness of waist and knees between the two groups (P>0.05), which was comparable. After treatment, the symptom scores of chest pain, chest tightness, palpitations, poor appetite, and soreness of waist and knees in the two groups were significantly lower than those before treatment (P<0.01), and the symptom scores of chest pain, chest tightness, palpitations, poor appetite, and soreness of waist and knees in the treatment group after treatment were lower than those in the control group, and the differences were statistically significant (P<0.05).

[0098] Table 3 Comparison of TCM syndrome scores between the two groups of patients before and after treatment ( point)

[0099]

[0100] Note: Compared with before treatment, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01

[0101] 2.5 Comparison of the incidence of adverse events between the two groups

[0102] 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 2.94%; in the treatment group, 1 patient had dizziness and 1 patient had gastrointestinal reaction, and the incidence of adverse events was 6.06%. 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 nourishing the kidney and strengthening the spleen, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10-40 parts of roasted turtle shell, 10-30 parts of mistletoe, 10-20 parts of eucommia bark, 10-30 parts of dodder seeds, 10-30 parts of cistanche deserticola, 10-30 parts of codonopsis pilosula, 10-30 parts of tuckahoe, 10-30 parts of polygonum cuspidatum, and 10-30 parts of ligusticum chuanxiong.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 30 parts of roasted turtle shell, 15 parts of mistletoe, 15 parts of eucommia bark, 15 parts of dodder seeds, 10 parts of cistanche, 10 parts of codonopsis pilosula, 10 parts of tuckahoe, 10 parts of polygonum cuspidatum and 15 parts of ligusticum chuanxiong.

3. A method for preparing a Chinese medicine composition for nourishing the kidney and strengthening the spleen, characterized in that: The following steps are involved: (1) Weigh the bulk drug according to claim 1 and set aside; (2) Crush the roasted turtle shell, sieve and set aside; (3) soaking the remaining medicinal ingredients in water, heating and refluxing for extraction, filtering to obtain a filtrate, concentrating it, mixing it with the roasted turtle shell powder in step (2), drying it, and granulating it.

4. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: The roasted turtle shell is roasted turtle shell with vinegar.

5. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: The roasted turtle shell is crushed and passed through a 100-mesh sieve.

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

7. A Chinese medicine preparation for nourishing the kidney and strengthening the spleen, characterized in that: The dry particles obtained by the preparation method of claim 3 are added with pharmaceutically acceptable excipients to prepare oral dosage forms such as tablets, capsules, and granules.

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

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

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