Mongolian medicine composition capable of nourishing blood and cardiac muscle, relaxing chest, diminishing swelling and inhibiting Badaozhi as well as preparation method and application of Mongolian medicine composition

Abstract

The invention provides a Mongolian medicine composition capable of nourishing blood and cardiac muscle, relaxing chest, diminishing swelling and inhibiting Bada dry Heray as well as a preparation method and application of the Mongolian medicine composition, and belongs to the technical field of Mongolian medicines. The Mongolian medicine composition provided by the invention is prepared from the following raw materials: fructus choerospondiatis, nutmeg, tabasheer, flos carthami, pomegranate, fructus crataegi, fructus tribuli, cluster mallow fruit, folium rhododendri daurici, fructus piperis longi, fructus tsaoko and fructus amomi rotundus. The Mongolian medicine composition provided by the invention has the effects of nourishing blood and cardiac muscle, inhibiting Badaozhi, relaxing chest and diminishing swelling, can be applied to treatment of chronic cardiac insufficiency, pulmonary heart disease, dilated heart disease and various edema, and can achieve a remarkable treatment effect.

Description

Technical Field

[0001] The invention belongs to the technical field of Mongolian medicines, and specifically relates to a Mongolian medicine composition capable of nourishing blood and myocardium, relieving chest swelling and inhibiting badaganheyi, as well as a preparation method and application thereof. Background Art

[0002] In modern society, cardiovascular disease has become one of the important factors threatening human health. Various heart diseases caused by insufficient blood supply to the myocardium seriously affect the quality of life and life safety of patients. At present, there are many treatments for myocardial-related diseases, including Western medicine treatment, surgical treatment, etc. Although Western medicine has a certain effect in relieving symptoms, long-term use is often accompanied by various side effects, causing damage to the patient's liver and kidney functions; surgical treatment has problems such as large trauma, high risk, and high cost, and is not suitable for all patients.

[0003] Badaganheyi is an important theoretical concept in Mongolian medicine. When the human body's Badaganheyi is unbalanced, it is easy to cause a variety of diseases, among which the impact on the cardiovascular system is particularly significant, which can lead to symptoms such as chest discomfort and abnormal heart function. In Mongolian medicine theory, regulating the balance of Badaganheyi is crucial to maintaining human health. Traditional Mongolian medicine has a long history and rich experience in treating cardiovascular diseases and regulating the balance of human functions. However, there are currently few Mongolian medicine products on the market that specifically target nourishing myocardium, inhibiting Badaganheyi, soothing the chest, and reducing swelling, and there is still room for improvement in the formulation and efficacy of existing related drugs. Therefore, the development of a Mongolian medicine that can effectively nourish myocardium, inhibit Badaganheyi, soothe the chest, and reduce swelling has important practical significance and broad market prospects. Summary of the invention

[0004] In view of this, the purpose of the present invention is to provide a Mongolian medicine composition that nourishes blood and myocardium, relaxes chest and reduces swelling, and inhibits badaganheyi, which has a significant therapeutic effect on chronic heart failure, cor pulmonale, dilated cardiomyopathy and various edemas.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The invention provides a Mongolian medicine composition for nourishing blood and myocardium, relaxing chest and reducing swelling, and inhibiting badaganheyi. The Mongolian medicine composition comprises the following raw materials in parts by weight: 20-300 parts of jujube, 20-200 parts of nutmeg, 10-200 parts of dahlia, 20-300 parts of safflower, 20-200 parts of pomegranate, 20-150 parts of square sea, 20-300 parts of tribulus terrestris, 20-150 parts of winter mallow fruit, 30-200 parts of red yam, 10-150 parts of piper longum, 10-200 parts of tsaoko and 10-150 parts of cardamom.

[0007] Preferably, the Tribulus terrestris is processed Tribulus terrestris.

[0008] The invention also provides a method for preparing the Mongolian medicine composition, which comprises crushing and mixing the raw materials.

[0009] Preferably, the powder is sieved through a 80-100 mesh sieve after being crushed.

[0010] Preferably, when the Mongolian medicine composition is in the form of pills, it also includes the steps of flooding the pills with water, polishing and drying.

[0011] Preferably, when water is used to make pills, the weight ratio of the powder mixture to water is 1:(0.5-0.6).

[0012] Preferably, the polishing is performed with water, and the weight ratio of the pills to water is 9 to 11:1.

[0013] Preferably, the drying temperature is 40°C to 50°C.

[0014] The present invention also provides the use of the Mongolian medicine composition or the preparation method in preparing a product for treating chronic heart failure, cor pulmonale, dilated cardiomyopathy or edema.

[0015] Beneficial effects of the present invention:

[0016] The Mongolian medicine composition provided by the invention has the effects of nourishing blood and myocardium, inhibiting badaganheyi, relaxing chest and reducing swelling, can be applied to the treatment of chronic heart failure, cor pulmonale, dilated cardiomyopathy and various edemas and can achieve significant therapeutic effects. DETAILED DESCRIPTION

[0017] The invention provides a Mongolian medicine composition for nourishing blood and myocardium, relaxing chest and reducing swelling, and inhibiting badaganheyi. The Mongolian medicine composition comprises the following raw materials in parts by weight: 20-300 parts of jujube, 20-200 parts of nutmeg, 10-200 parts of dahlia, 20-300 parts of safflower, 20-200 parts of pomegranate, 20-150 parts of square sea, 20-300 parts of tribulus terrestris, 20-150 parts of winter mallow fruit, 30-200 parts of red yam, 10-150 parts of piper longum, 10-200 parts of tsaoko and 10-150 parts of cardamom.

[0018] The Mongolian medicine composition of the present invention preferably includes the following raw materials in parts by weight: 50-200 parts of Fructus jujubae, 60-150 parts of Myristica fragrans, 50-150 parts of Rhizoma dahliae, 50-200 parts of Carthamus tinctorius, 80-150 parts of Pomegranate, 50-130 parts of Rhizoma squarrosa, 50-200 parts of Tribulus terrestris, 80-120 parts of Malva ovata, 60-150 parts of Rhizoma serratae, 20-120 parts of Piper longum, 12-100 parts of tsaoko and 13-100 parts of cardamom, more preferably including the following raw materials in parts by weight: 133.33 parts of jujube, 100 parts of nutmeg, 100 parts of gardenia, 100 parts of safflower, 100 parts of pomegranate, 100 parts of square sea, 100 parts of tribulus terrestris, 100 parts of winter mallow fruit, 100 parts of red yam, 33.33 parts of piper longum, 16.66 parts of tsaoko and 16.66 parts of cardamom.

[0019] The present invention has no special restrictions on the specific sources of the raw materials in the Mongolian medicine composition, wherein the Tribulus terrestris is preferably processed Tribulus terrestris, and the processed Tribulus terrestris is preferably stir-fried Tribulus terrestris. The present invention has no special restrictions on the stir-frying method of Tribulus terrestris, and the conventional stir-frying method of Tribulus terrestris in the art can be used. In the Mongolian medicine composition of the present invention, the Fructus Achyranthis Bidentatae is sour and sweet, has a flat nature, is the main drug, and has the functions of clearing away heart heat, tonifying the heart and replenishing qi. Nutmeg, rhubarb, safflower, pomegranate, Chinese hollyhock, tribulus terrestris, winter mallow fruit and red hollyhock are ministerial drugs, among which nutmeg: spicy, warm in nature, has the effects of calming the stomach, helping stomach fire, digesting food and stimulating appetite. It is a good medicine for the heart, mainly treating heart diseases such as chest tightness, shortness of breath, dizziness and insomnia; rhubarb: sweet, cool in nature, has the effects of clearing heat, relieving cough and reducing jaundice (liver protection function); safflower: sweet, slightly bitter, cool in nature, has the effects of locking the meridians, clearing liver blood heat and increasing coronary blood flow; pomegranate is sour and sweet, hot in nature, has the effects of helping stomach fire, removing hepatitis and stimulating appetite; Chinese hollyhock is salty and cold in nature, has the effects of clearing heat, reducing swelling and diuresis; tribulus is sweet and slightly bitter, has the effects of removing kidney hepatitis, diuresis and reducing swelling; winter mallow fruit is sweet and astringent, cool in nature, has the effects of opening the meridians, diuresis and reducing swelling; red hollyhock is spicy, bitter and warm in nature. Piper longum is an adjuvant, which is pungent and warm in nature. It has the effects of helping stomach fire, removing badaganheyi, harmonizing body elements, strengthening yang (tonifying kidney), relieving asthma, removing phlegm and relieving pain. Amomum villosum and cardamom are guiding drugs. Among them, amomum villosum is pungent and warm in nature, helping stomach fire and promoting digestion; cardamom is pungent, slightly bitter, and warm in nature. It has the effects of removing cold and helping stomach fire, digesting food and stimulating appetite. It is a good medicine for life, and is mainly used to treat insomnia, dizziness, asthma and other symptoms caused by life.

[0020] The invention also provides a method for preparing the Mongolian medicine composition, which comprises crushing and mixing the raw materials.

[0021] The present invention has no special restrictions on the specific method of crushing. After crushing, it is preferably passed through an 80-mesh to 100-mesh sieve to ensure that the powder obtained by crushing can all pass through the 80-mesh sieve, and more than 95% of the powder can pass through the 100-mesh sieve. In the present invention, when the Mongolian medicine composition is a pill, it is preferably further included in the steps of water-filled pills, polished and dried. When water-filled pills, the weight ratio of the powder mixture to water is preferably 1: (0.5-0.6), more preferably 1: (0.52-0.58). In the present invention, the polishing is preferably water-filled, and the weight ratio of the pills to water is preferably 9-11: 1, more preferably 10: 1. The present invention has no special restrictions on the specific methods of water-filled pills and water-filled pills, and the conventional method of water pills in the field can be used. In the present invention, the drying temperature is preferably 40°C to 50°C, more preferably 42°C to 48°C. In the present invention, the Mongolian medicine composition pills preferably weigh 1.84-2.16 g per 10 pills, and 13-15 pills are taken at a time, 1-2 times a day, with warm water.

[0022] The present invention also provides the use of the Mongolian medicine composition or the preparation method in preparing a product for treating chronic heart failure, cor pulmonale, dilated cardiomyopathy or edema. In the present invention, the product preferably includes a medicine.

[0023] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0024] In the following embodiments, unless otherwise specified, all of them are conventional methods.

[0025] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0026] Example 1

[0027] A Mongolian medicine composition for nourishing blood and myocardium, relaxing chest and reducing swelling, and inhibiting badaganheyi. The Mongolian medicine composition is prepared from the following raw materials: 133.33g of jujube, 100g of nutmeg, 100g of dahlia, 100g of safflower, 100g of pomegranate, 100g of ophiopogon, 100g of processed tribulus terrestris (the processed tribulus terrestris is stir-fried tribulus terrestris), 100g of okra, 100g of red safflower, 33.33g of piper longum, 16.66g of tsaoko and 16.66g of cardamom.

[0028] Example 2

[0029] The preparation method of the Mongolian medicine water pills for nourishing blood and myocardium, relaxing chest and reducing swelling and inhibiting Bada Ganheyi is composed of the following steps:

[0030] (1) Accurately weigh 133.33 g of Ziziphus jujuba, 100 g of Myristica fragrans, 100 g of Radix dahliae, 100 g of Carthamus tinctorius, 100 g of Pomegranate, 100 g of Rhizoma Anemarrhenae, 100 g of processed Tribulus terrestris (the processed Tribulus terrestris is stir-fried Tribulus terrestris), 100 g of Malus domestica, 100 g of Rhizoma Amaranthus, 33.33 g of Piper longum, 16.66 g of Amomum villosum, and 16.66 g of Cardamom;

[0031] (2) Mix and crush the clean medicinal materials of jujube, nutmeg, pomegranate and tsaoko, pour them into the premixing tank and mix them with the other 8 clean medicinal materials, then pour them into the grinder and start grinding. During the grinding process, check the grinding fineness. If 100g of the medicinal powder is weighed and all of it passes through an 80-mesh sieve, and the equipment is stopped when the powder that can pass through a 100-mesh sieve is not less than 95%, the powder is stopped. The sieved medicinal powder is mixed with an SBH-200 three-dimensional mixer at a speed of 9 r / min for 20 minutes.

[0032] (3) Demolding: The weight of the whole powder = the weight of the whole powder / 0.2×1000×0.01; The weight of the demolded powder = the weight of the whole powder / 6. The demolded powder is put into a pill-making machine, and purified water is used as a binder to form the powder into fine particles. The weight ratio of powder to purified water is 1:0.5.

[0033] (4) Pill making and drug screening: First, pour the mold into the pill making machine and rotate it (the speed of the pill making machine is 40 rpm). During the pill making process, the pellets (wet) are screened with a rolling screen at any time until uniform-sized drug pellets with a diameter of 7.0 mm to 8.0 mm are obtained.

[0034] (5) Place the wet pills in a tray and spread them evenly to a thickness of no more than 3 cm. Move them into the drying room, set the temperature to 40℃~50℃, turn on the fan, and start heating and drying. Turn them over every hour during the drying process. Do not turn them over until the surface of the wet pills is dry and the color is uniform.

[0035] (6) Polishing: Use ZMG-1000 infinitely slow stainless steel sugar coating machine for polishing, and use purified water for polishing. The weight ratio of pills to purified water is 10:1.

[0036] (7) Drying: Place the polished pills on a tray and spread them evenly to a thickness of no more than 3 cm. Transport them to a drying room and dry them at room temperature for 1 hour. Set the temperature to 40°C to 50°C and turn on the fan. Turn the pills over every hour during the drying process. Drying is completed when the pills cannot be crushed by hand and the moisture content is no more than 8%. The weight of every 10 pills is in the range of 1.84 to 2.16.

[0037] The Mongolian medicine water pills prepared by the preparation method of the present invention have a round appearance, uniform size and color, no adhesion, can be completely dissolved within 60 minutes, the moisture content does not exceed 8%, the weight difference limit is ±7%, no more than 2 parts exceed the weight difference limit, and no one part exceeds the limit by 1 times.

[0038] Example 3

[0039] A Mongolian medicine composition for nourishing blood and myocardium, relaxing chest and reducing swelling, and inhibiting badaganheyi is prepared from the following raw materials: 20g of jujube, 20g of nutmeg, 10g of dahlia, 20g of safflower, 20g of pomegranate, 20g of hollyhock, 20g of processed tribulus terrestris (the processed tribulus terrestris is stir-fried tribulus terrestris), 20g of winter mallow fruit, 30g of red safflower, 10g of piper longum, 10g of tsaoko and 10g of cardamom.

[0040] The difference between the preparation method and Example 2 is that the weighing numbers of each medicinal flavor in step (1) are different, and the rest are the same as Example 2.

[0041] Example 4

[0042] A Mongolian medicine composition for nourishing blood and myocardium, relaxing chest and reducing swelling, and inhibiting badaganheyi is prepared from the following raw materials: 300g of jujube, 200g of nutmeg, 200g of dahlia, 300g of safflower, 200g of pomegranate, 150g of smilax china, 300g of processed tribulus terrestris (the processed tribulus terrestris is stir-fried tribulus terrestris), 150g of okra, 200g of red safflower, 150g of piper longum, 200g of tsaoko and 150g of cardamom.

[0043] The difference between the preparation method and Example 2 is that the weighing numbers of each medicinal flavor in step (1) are different, and the rest are the same as Example 2.

[0044] Example 5

[0045] 1. Case source: 76 patients with chronic heart failure who were admitted to the outpatient clinic and inpatient department of cardiology at Xing'an League Mongolian Hospital, Inner Mongolia Autonomous Region from January 2023 to December 2024 were selected as the research subjects.

[0046] 2. Diagnostic criteria

[0047] 2.1 Western medicine diagnostic criteria: The diagnostic criteria are formulated in accordance with the "Guidelines for the Diagnosis and Treatment of Heart Failure in China 2018":

[0048] (1) Based on the patient's medical history: coronary heart disease, hypertension, obesity, use of diuretics, orthopnea / paroxysmal nocturnal dyspnea.

[0049] (2) Combined with the patient's physical examination: lung rales, edema of both lower limbs, heart murmurs, fullness of the jugular veins, and lateral displacement or diffuseness of the apical beat.

[0050] (3) Related auxiliary examinations: electrocardiogram, chest X-ray, abnormal cardiac structure and / or function, NT-proBNP ≥ 125 ng / L.

[0051] (4) NYHA classification of cardiac function: formulated with reference to the New York Heart Association (NYHA) cardiac function classification standards.

[0052] Heart function level I: No limitation in activities. Daily physical activities do not cause obvious shortness of breath, fatigue or palpitations.

[0053] Heart function class II: Mild limitation of activity. No symptoms at rest, but daily activities may cause obvious shortness of breath, fatigue or palpitations.

[0054] Heart function level III: Activities are significantly limited. Even light daily activities can cause significant shortness of breath, fatigue or palpitations.

[0055] Heart function level IV: Symptoms occur even at rest, and any physical activity will cause discomfort.

[0056] 2.2 Mongolian medicine diagnostic standards: refer to the "Textbook of Mongolian Internal Medicine" (edited by Su Rongzhabu, Nationalities Publishing House, second edition, 2011), and the "Mongolian Medicine Disease Diagnosis and Ethnic Effect Standards" (edited by Wu Lan, Nationalities Publishing House, 2007).

[0057] (1) Main clinical manifestations: Cardiac edema and primary heart disease worsen, and symptoms such as palpitations, chest tightness, and shortness of breath are prominent, sleep is not sound, edema increases and decreases unpredictably, and edema of the calves and insteps is obvious.

[0058] (2) Auxiliary examinations: electrocardiogram, cardiac ultrasound, BNP (or NT-proBNP), etc.

[0059] (3) Tongue, pulse and urine:

[0060] Tongue: Dark purple tongue (or with ecchymoses, petechiae, or tortuous purple veins under the tongue):

[0061] Pulse: thin, deep and irregular;

[0062] Urine: small amount and dark color;

[0063] The diagnosis can be confirmed if the patient has the above three main clinical manifestations and two or more auxiliary examination items, combined with tongue, pulse and urine images.

[0064] 3. Inclusion criteria:

[0065] (1) The patient meets the diagnostic criteria of chronic heart failure in Western medicine and the syndrome differentiation criteria of Jiruhenha collapse syndrome (chronic heart failure) in Mongolian medicine.

[0066] (2) The main research subjects for long-term drug observation are patients with chronic heart failure of NYHA grade II-III.

[0067] (3) The patient's age was between 45 and 75 years old, regardless of gender.

[0068] (4) Inform patients and their families of the purpose of the study. Patients are encouraged to voluntarily participate and follow the doctor's instructions for treatment.

[0069] 4. Exclusion criteria:

[0070] (1) Patients with heart failure due to failure of important organs such as liver and kidney.

[0071] (2) Pregnant or lactating women, people with allergic constitutions, and those who are allergic to multiple drugs.

[0072] (3) Those who have mental disorders and cannot cooperate with treatment.

[0073] (4) Those who are currently participating in other clinical trials.

[0074] (5) The efficacy of the treatment cannot be determined due to various reasons or the data are incomplete.

[0075] (6) Factors that may increase mortality, such as cardiogenic shock, severe ventricular arrhythmias, complete atrioventricular block, obstructive cardiomyopathy, severe valvular disease, constrictive pericarditis, cardiac tamponade, pulmonary embolism, and patients with significant infection and poorly controlled severe hypertension, are not recommended.

[0076] 5. Treatment methods:

[0077] (1) 76 patients who met the criteria were randomly divided into a control group and a treatment group, with 38 cases in each group. The control group was given basic Western medicine treatment, and the treatment group was given the Mongolian medicine water pill obtained in Example 2 (the Mongolian medicine water pill is called Xinwuerile) in addition to the basic Western medicine treatment. The course of treatment was 4 weeks.

[0078] (2) Mongolian medicine composition Xinwuerile: Usage: 15 capsules / time, 2 times / day, take on an empty stomach in the morning and with warm water after dinner. The course of treatment is 4 weeks.

[0079] (3) Basic Western medicine treatment: 75 mg of irbesartan (or 40 mg of telmisartan), taken orally once a day, 12.5 mg to 25 mg of metoprolol tartrate, taken orally twice a day (or 5 mg of bisoprolol, taken orally once a day). Oxygen inhalation is given according to the changes in the patient's condition during treatment, and the type, dosage and method of administration of the drug are adjusted. At the same time, blood pressure is controlled according to the cause of the disease, urine volume and blood potassium changes are monitored, and diuretics and potassium supplements are given.

[0080] (4) All patients included in the trial should follow a low-salt and low-fat diet, avoid being too hungry or too full, limit fluid intake, regulate their emotions, avoid wind and cold, quit smoking and limit alcohol consumption, and get enough rest.

[0081] 6. Observation indicators

[0082] 6.1 Case data

[0083] 6.1.1 Safety indicators

[0084] (1) Monitor body temperature, respiration, pulse, blood pressure, and heart rate.

[0085] (2) Routine blood, urine, and stool tests, myocardial enzymes, liver function, kidney function, and ions.

[0086] (3) Closely observe adverse reactions during treatment and record them in detail to determine the condition.

[0087] 6.1.2 Efficacy indicators

[0088] (1) Heart function classification (NYHA).

[0089] (2) NT-proBNP.

[0090] (3) Determination of the efficacy of Mongolian medicine.

[0091] (4) Cardiac ultrasound examination of left ventricular ejection fraction (LVEF).

[0092] 6.2 Criteria for evaluating therapeutic efficacy

[0093] 6.2.1 Improvement of cardiac function is based on the NYHA classification method, and the efficacy criteria are:

[0094] Markedly effective: heart failure is basically controlled or heart function is improved by 2 levels or more.

[0095] Effective: Heart function improved by 1 level but less than 2 levels.

[0096] Ineffective: Heart function improves by less than 1 grade or even worsens.

[0097] 6.2.2 NT-proBNP efficacy assessment

[0098] The changes of NT-proBNP levels in the two groups were observed before and after treatment.

[0099] 6.2.3 Mongolian medical efficacy evaluation criteria

[0100] Markedly effective: The main symptoms such as edema, chest tightness, shortness of breath, and palpitations were significantly improved or disappeared; ECG, cardiac color ultrasound, NT-proBNP, etc. were significantly improved or normal.

[0101] Effective: Symptoms and signs such as edema, chest tightness, shortness of breath, and palpitations improved; ECG, cardiac ultrasound, and NT-proBNP improved.

[0102] Ineffective: Symptoms such as chest tightness, shortness of breath, palpitations, and ECG, cardiac ultrasound, NT-proBNP and other examinations did not improve or worsen.

[0103] 6.2.4 Left ventricular ejection fraction (LVEF) efficacy assessment

[0104] The changes of LVEF in the two groups were observed before and after treatment.

[0105] 6.3 Statistical analysis

[0106] SPSS25.0 statistical software was used to analyze and process the data. The measurement data were expressed as mean ± standard deviation. The data that met the normal distribution were subjected to t test, and the data that were not normally distributed were subjected to rank sum test. The rank sum test was used for the graded data, and the chi-square test was used for the count data. The results of the study were analyzed, and P < 0.05 indicated statistical significance.

[0107] 7. Results

[0108] 7.1 General Data Analysis

[0109] The trial initially enrolled 76 cases, including 38 in the control group and 38 in the experimental group. During the trial, 3 cases in the control group were found to drop out due to self-discharge or withdrawal; 3 cases in the treatment group were excluded due to refusal to take Mongolian medicine and discharge from the hospital midway. After the trial, 70 cases met the research criteria.

[0110] 7.1.1 There was no statistically significant difference in age, gender, disease course, and cardiac function grade between the treatment group and the control group, and the two groups were considered comparable (see Table 1 and Table 2 for details).

[0111] Table 1 Gender, age and disease course distribution of the two groups

[0112] Group Number of cases Age (years) Gender (male / female) Average duration of disease / year Control group 35 66.40±9.76 18 / 17 5.50±1.68 Treatment Group 35 63.73±10.03 20 / 15 5.76±1.83 Z / T value 0.223 0.278 1.003 P 0.832* <![CDATA[0.604 # ]]> <![CDATA[0.320 △ ]]>

[0113] Note: After testing, *P>0.05, # P>0.05, △ P>0.05.

[0114] Table 2 Comparison of cardiac function classification

[0115] Group Number of cases Level II Grade III <![CDATA[X 2 ]]> P Control group 35 16 19 0.067 0.795* Treatment Group 35 15 20 0.320

[0116] Note: After chi-square test, *P>0.05.

[0117] 7.2 Efficacy Analysis

[0118] 7.2.1 Comparison of Mongolian medical symptom scores

[0119] As shown in Table 3, the comparison between the two groups before treatment was P>0.05, and the difference was not statistically significant, which was comparable. The comparison within the two groups was P<0.05, and the difference was statistically significant. The scores of both groups decreased after treatment, but the difference in the treatment group was greater than that in the control group P<0.05, and the effect of the treatment group was better than that of the control group. The scores in Table 3 are based on the scores of the main and secondary symptoms of the "Encyclopedia of Mongolian Studies·Medical Volume" edited by Ce·Surongzabu and published in 2002, "Mongolian Internal Medicine" published in 2011, "Chinese Medical Encyclopedia Mongolian Medicine Volume" edited by Bai Qingyun and published in 1986, and "Mongolian Medical Disease Diagnosis and Efficacy Standards" edited by Ulan and published in 2007. The specific score statistics are shown in Table 4.

[0120] Table 3 Comparison of Mongolian medicine symptom scores before and after treatment (mean ± standard deviation)

[0121] Group Number of cases Pre-treatment score After treatment score Before and after difference Control group 35 <![CDATA[41.16±5.32 △ ]]> 20.02±2.98* <![CDATA[19.12±2.86 # ]]> Treatment Group 35 42.46±5.34 16.12±3.08* 25.44±3.02 Z / T value ﹣0.297 1.021 ﹣8.021 P 0.767 0.0001 0.001

[0122] Note: After testing, compared with the treatment group before treatment △ P>0.05, compared with the group before treatment *P<0.05, compared with the difference in the treatment group # P<0.05.

[0123] Table 4 Statistics of Mongolian medicine symptom scores

[0124]

[0125] 7.2.2 Comparison of Mongolian medical efficacy

[0126] As shown in Table 5, the comparison of Mongolian medical efficacy between the two groups showed that the treatment group was superior to the control group (P < 0.05), and the difference was statistically significant.

[0127] Table 5 Comparison of Mongolian medical efficacy [N (%)]

[0128] Group Number of cases Significant effect efficient invalid deterioration Total effective z P Control group 35 10(29) 13(37) 12(34) 0(0) 23(66) ﹣2.116 0.035 Treatment Group 35 15(43) 14(40) 6(17) 0(0) 29(83)

[0129] Note: The rank sum test was used for comparison, P < 0.05.

[0130] 7.2.3 Comparison of cardiac function efficacy between the two groups after treatment

[0131] As shown in Table 6, the treatment group was superior to the control group in terms of the efficacy of cardiac function symptoms between the two groups (P < 0.05), and the difference was statistically significant.

[0132] Table 6 Comparison of efficacy on cardiac function [N (%)]

[0133] Group Number of cases Significant effect efficient invalid deterioration Total effective z P Control group 35 7(20) 14(40) 14(40) 0(0) 21(60) ﹣2.126 0.034 Treatment Group 35 11(31) 14(40) 10(29) 0(0) 25(71)

[0134] Note: P<0.05 using rank sum test.

[0135] 7.2.4 Comparison of NT-proBNP values ​​between the two groups before and after treatment

[0136] As shown in Table 7, there was no significant difference in NT-proBNP between the two groups before treatment (P>0.05), which was comparable. After treatment, NT-proBNP decreased in both groups, but the decrease in the treatment group was greater than that in the control group, and the difference was statistically significant (P<0.05).

[0137] Table 7 Comparison of NT-proBNP levels between the two groups of patients after treatment (mean ± standard deviation)

[0138] Group Number of cases Pre-treatment score After treatment score Before and after difference Control group 35 1878.30±325.36 320.02±20.98* <![CDATA[1519.12±302.86 # ]]> Treatment Group 35 <![CDATA[1886.30±335.08 △ ]]> 316.12±23.08* 1525.44±303.02 Z / T value 0.117 -3.460 1.423 P 0.914 0.001 0.0001

[0139] Note: After testing, compared with the treatment group before treatment △ P>0.05, compared with the group before treatment *P<0.05, compared with the difference in the treatment group # P<0.05.

[0140] 7.2.5 Comparison of LVEF (%) levels between the two groups before and after treatment

[0141] As shown in Table 8, there was no statistically significant difference in LVEF values ​​before treatment between the two groups (P>0.05). They were comparable. The difference between the two groups after treatment and before treatment was P<0.05, indicating that both groups could increase LVEF (%) values, but the increase in the treatment group was greater than that in the control group (P<0.05), and the difference was statistically significant, proving that the treatment group was better than the control group.

[0142] Table 8 Comparison of LVEF (%) levels between the two groups of patients after treatment (mean ± standard deviation)

[0143]

[0144]

[0145] Note: After testing, compared with the treatment group before treatment △ P>0.05, compared with the group before treatment *P<0.05, compared with the difference in the treatment group # P<0.05.

[0146] 7.3 Safety index results

[0147] The 70 patients who completed the clinical observation were given routine tests of body temperature, pulse, respiration, blood pressure, and heart rate. Blood, urine, stool routine tests, liver function, kidney function and other safety indexes were checked before and after treatment. There was no significant change in the safety indicators of the two groups of patients before and after treatment, and the fluctuations were relatively stable. No obvious adverse reactions occurred during the observation process, so it can be determined that the Mongolian medicine combination Xinwurile used in this observation has good safety.

[0148] Example 6

[0149] Lai, 70 years old, female, complained of intermittent chest tightness, shortness of breath, precordial pain for 4 years, and was hospitalized for 10 days with increased aggravation of edema of both lower limbs. With symptoms such as dizziness, palpitations, and fatigue. Physical examination: clear mind and speech, coarse breath sounds in both lungs, regular heart rhythm, no pathological murmurs, and edema of both lower limbs. Electrocardiogram: sinus rhythm, left ventricular high voltage T wave changes, fast ventricular rate. NT-BNP: 3740.0pg / ml, cardiac color Doppler ultrasound: left heart slightly enlarged, cardiac function decreased, EF ejection fraction <40%. Give vasodilation, diuresis, telmisartan, metoprolol tablets combined with Mongolian medicine composition Xinwu Ri Le (Mongolian medicine composition pills are 1.84g per 10 pills, 13 pills at a time when taking, once a day, warm water delivery) After 7 days of treatment, the patient's chest tightness, shortness of breath, precordial pain, palpitations, fatigue and other symptoms have improved significantly and were discharged from the hospital. After being discharged from the hospital and taking oral medication for one month, the NT-BNP was re-examined: 268.0pg / ml, and the electrocardiogram showed ectopic rhythm, atrial fibrillation, and ST-T changes. Cardiac ultrasound: the left heart was slightly enlarged, and the EF ejection fraction was >40%.

[0150] Example 7

[0151] Zhou, male, 67 years old, the main cause is intermittent chest tightness and shortness of breath, aggravated after activity. Physical examination: clear mind and speech, coarse breath sounds in both lungs, moist rales and regular heart rhythm can be heard at the bottom of both lungs, no pathological murmurs can be heard, and both lower limbs are swollen. Electrocardiogram shows: ectopic rhythm, atrial fibrillation, ST-T changes; cardiac color Doppler ultrasound prompts: whole heart enlargement, a small amount of mitral and tricuspid valve regurgitation, reduced left ventricular diastolic function, EF ejection fraction 46%. After two months of treatment with the Mongolian medicine composition obtained in Example 1 (the Mongolian medicine composition pill is 2.16g per 10 pills, 15 pills at a time, 2 times a day, and warm water is taken), the above symptoms are significantly improved. Electrocardiogram shows: ectopic rhythm, atrial fibrillation, ST-T changes; re-examination of cardiac color Doppler ultrasound prompts: left atrium enlargement, a small amount of mitral and tricuspid valve regurgitation, reduced heart function, and EF ejection fraction 50%.

[0152] Example 8

[0153] Liu, female, 60 years old, the main cause is intermittent chest tightness and shortness of breath for 3 years, aggravation of edema of both lower limbs for 1 week. Physical examination: clear mind and speech, good spirit, coarse breath sounds of both fat, no dry and wet rales, electrocardiogram prompts: sinus tachycardia, T wave changes; cardiac color Doppler ultrasound prompts: left heart enlargement, moderate mitral valve regurgitation, tricuspid valve, aortic valve mild regurgitation, left ventricular diastolic function reduction, EF ejection fraction 42%. Through Mongolian and Western medicine combined with vasodilation, nutrition myocardial, relieve heart burden treatment, enalapril, metoprolol combined with embodiment 3 obtained Mongolian medicine composition (Mongolian medicine composition pill is every 10 weight 2.16g, 15 tablets once when taking, 2 times a day, warm water delivery) treatment 1 month after the above-mentioned symptoms are significantly improved, recheck cardiac color Doppler ultrasound shows: left atrium enlargement, a small amount of mitral valve regurgitation, left ventricular diastolic function reduction, EF ejection fraction 50%.

[0154] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Mongolian medicine composition for nourishing blood and myocardium, relaxing chest and reducing swelling, and inhibiting Bada Ganheyi, characterized in that: The Mongolian medicine composition comprises the following raw materials in parts by weight: 20-300 parts of jujube, 20-200 parts of nutmeg, 10-200 parts of gardenia, 20-300 parts of safflower, 20-200 parts of pomegranate, 20-150 parts of square sea, 20-300 parts of tribulus terrestris, 20-150 parts of winter mallow fruit, 30-200 parts of red yam, 10-150 parts of piper longum, 10-200 parts of tsaoko and 10-150 parts of cardamom.

2. The Mongolian medicine composition according to claim 1, characterized in that The Tribulus terrestris is processed Tribulus terrestris.

3. The method for preparing the Mongolian medicine composition according to claim 1 or 2, characterized in that: Grind and mix the raw materials.

4. The preparation method according to claim 3, characterized in that: After crushing, pass through 80-100 mesh sieve.

5. The preparation method according to claim 3, characterized in that: When the Mongolian medicine composition is in the form of pills, the steps of flooding the pills with water, polishing and drying are also included.

6. The preparation method according to claim 5, characterized in that: When making pills with water, the weight ratio of the powder mixture to water is 1:(0.5-0.6).

7. The preparation method according to claim 5, characterized in that: The polishing is performed with water, and the weight ratio of the pills to water is 9 to 11:

1.

8. The preparation method according to claim 5, characterized in that: The drying temperature is 40°C to 50°C.

9. Use of the Mongolian medicine composition described in any one of claims 1 to 2 or the preparation method described in any one of claims 3 to 8 in the preparation of products for treating chronic heart failure, cor pulmonale, dilated cardiomyopathy or edema.

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