A traditional Chinese medicine composition for treating heart failure with spleen deficiency and a preparation method thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating spleen deficiency syndrome heart failure with cognitive dysfunction, including the following weight parts of traditional Chinese medicine composition: 18-22 parts of Huangqi, 8-12 parts of Renshen, 13-17 parts of Baishu, 13-17 parts of Shanyao, 13-17 parts of Fuling, 8-12 parts of Zexie, 8-12 parts of Huangjing, 8-12 parts of Danggui, 8-12 parts of Chuanqiong, 8-12 parts of Maidong, 8-12 parts of Zhimu, 5-7 parts of Wuyi, 8-12 parts of Chenpi, 5-7 parts of Guizhi, 8-12 parts of Hongjingtian, 10-14 parts of Wujiapi and 5-7 parts of Zhigancao.The preparation method of the present application is mainly decoction and granulation.The present application is suitable for spleen deficiency syndrome, such as fatigue, chest tightness, dyspnea, edema, dizziness, palpitation, abdominal distension, poor appetite, or cold, weak or loose stool, difficult urination, dull expression, slow speech and action, and other symptoms.Specifically suitable for heart failure with cognitive dysfunction with the above symptoms.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating heart failure with cognitive dysfunction due to spleen deficiency and a preparation method thereof. BACKGROUND

[0002] Heart failure is a series of clinical syndromes caused by various heart diseases in the end-stage. Studies have shown that the prevalence of heart failure with cognitive dysfunction can reach 20-80%, and such patients have poor self-management and treatment compliance, and have higher readmission rate and mortality.

[0003] At present, the pathophysiological mechanism of how heart failure affects cognitive dysfunction is still being further explored, and there is no specific and effective method for its prevention and treatment.

[0004] In traditional Chinese medicine, heart failure belongs to the category of "heart water", "suspended drink", "edema", "asthma", "heart distension", etc. At present, the syndrome differentiation types of heart failure treated by traditional Chinese medicine are mainly concentrated in yang deficiency and blood stasis, qi deficiency and blood stasis, and qi and yin deficiency and blood stasis.

[0005] Although there are many traditional Chinese medicines for treating heart failure based on the above-mentioned types at present, there are few drugs for treating heart failure with cognitive dysfunction, and the prevention and treatment methods of heart failure combined with cognitive dysfunction in traditional Chinese medicine and Western medicine are still being researched and explored. SUMMARY

[0006] The present application is based on the theory of heart-spleen-brain co-mechanism in traditional Chinese medicine, and through clinical practice observation and in-depth research, a traditional Chinese medicine composition for effectively treating heart failure with cognitive dysfunction due to spleen deficiency and a preparation method thereof are developed.

[0007] The technical scheme of the present application is as follows:

[0008] In a first aspect, a traditional Chinese medicine composition for treating heart failure with cognitive dysfunction due to spleen deficiency comprises the following components in parts by weight: 18-22 parts of Huangqi, 8-12 parts of Renshen, 13-17 parts of Baizhu, 13-17 parts of Shanyao, 13-17 parts of Fuling, 8-12 parts of Zexie, 8-12 parts of Huangjing, 8-12 parts of Dangui, 8-12 parts of Chuanqiong, 8-12 parts of Maidong, 8-12 parts of Zhimu, 5-7 parts of Wuyi, 8-12 parts of Chenpi, 5-7 parts of Guizhi, 8-12 parts of Hongjingtian, 10-14 parts of Wujiapi, and 5-7 parts of Zhigancao.

[0009] Preferred, the traditional Chinese medicine composition includes the following parts by weight: 20 parts Astragalus membranaceus, 9 parts Ginseng, 15 parts Atractylodes macrocephala, 15 parts Dioscorea opposita, 15 parts Poria cocos, 10 parts Alisma plantago-aquatica, 9 parts Polygonatum sibiricum, 9 parts Angelica sinensis, 9 parts Ligusticum chuanxiong, 10 parts Ophiopogon japonicus, 9 parts Anemarrhena asphodeloides, 6 parts Schisandra chinensis, 10 parts Citrus reticulata peel, 6 parts Cinnamomum cassia, 9 parts Rhodiola rosea, 12 parts Acanthopanax senticosus, and 6 parts Glycyrrhiza uralensis (processed).

[0010] In the second aspect, a method for preparing a traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency includes the following steps:

[0011] (1) Weigh out the Chinese herbal composition by weight, add water 8 times the weight of the Chinese herbal composition and decoct for 2 hours for the first decoction, then filter to obtain the residue and the first decoction liquid.

[0012] (2) Add water equal to 8 times the weight of the Chinese herbal medicine composition to the filter residue and decoct for a second time. The second decoction is 1.5 hours. Filter to obtain the second decoction. Combine the first decoction and the second decoction to obtain the filtrate.

[0013] (3) Let the filtrate stand, take the supernatant and concentrate it under reduced pressure to a thick paste with a relative density of 1.3 to 1.4;

[0014] (4) Add xylitol and dextrin, mix well, granulate, dry, and package to obtain the final product.

[0015] Preferably, in step (3), the relative density is the density of the paste relative to water at 60°C.

[0016] Preferably, in step (3), the temperature of the vacuum concentration is 60-80°C and the pressure is 0.06-0.08 MPa.

[0017] Preferably, in step (4), the weight ratio of xylitol:dextrin:thick paste is 1:4:2.

[0018] The heart failure with cognitive impairment described in this invention belongs to the spleen deficiency syndrome.

[0019] Fang Zhong:

[0020] Astragalus: Sweet in taste and slightly warm in nature; enters the spleen and lung meridians. It tonifies qi and strengthens the spleen, raises yang and lifts prolapse, benefits wei qi and consolidates the exterior, promotes diuresis and reduces swelling, and promotes tissue regeneration and detoxification.

[0021] Ginseng: Sweet and slightly bitter in taste, slightly warm in nature, and enters the spleen, lung, and heart meridians. It greatly replenishes vital energy, strengthens the spleen and lungs, promotes the production of body fluids, calms the mind, and improves intelligence.

[0022] Atractylodes macrocephala: sweet, bitter, and warm. It enters the spleen and stomach meridians, and invigorates qi and strengthens the spleen, while also drying dampness and promoting diuresis.

[0023] Yam: Sweet, neutral. It enters the spleen, lung, and kidney meridians. It nourishes qi and yin, and tonifies the spleen, lungs, and kidneys.

[0024] Poria cocos: sweet and bland in taste, neutral in nature, and enters the heart, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind.

[0025] Alisma plantago-aquatica: Sweet in taste and cold in nature. It enters the kidney and bladder meridians, and promotes diuresis, eliminates dampness, and clears heat.

[0026] Polygonatum: Sweet, neutral, enters the spleen, lung, and kidney meridians. It replenishes qi and nourishes yin, strengthens the spleen, moistens the lungs, and benefits the kidneys.

[0027] Angelica sinensis: sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. It nourishes blood and regulates menstruation, invigorates blood circulation and relieves pain; it also moistens the intestines and promotes bowel movements.

[0028] Chuanxiong (Ligusticum striatum): pungent in taste and warm in nature. It enters the liver, gallbladder, and pericardium meridians. It invigorates blood circulation, promotes qi flow, dispels wind, and relieves pain.

[0029] Ophiopogon japonicus: Sweet and slightly bitter in taste, slightly cold in nature. It enters the stomach, lung, and heart meridians. It nourishes yin and moistens the lungs, benefits the stomach and promotes the production of body fluids, and clears the heart and relieves irritability.

[0030] Anemarrhena asphodeloides: bitter, sweet, and cold. It enters the lung, stomach, and kidney meridians. It clears heat and drains fire, nourishes yin and moistens dryness.

[0031] Schisandra chinensis: Sour and sweet in taste, warm in nature. It enters the lung, heart, and kidney meridians. It astringes lung qi, replenishes qi and generates fluids, and tonifies the kidneys and calms the mind.

[0032] Dried tangerine peel: pungent, bitter, and warm. It enters the spleen and lung meridians. It regulates qi, strengthens the spleen, harmonizes the middle jiao, dries dampness, and resolves phlegm.

[0033] Cinnamon twig: pungent and sweet in taste, warm in nature. It enters the heart, lung, and bladder meridians. It warms and unblocks the meridians, and assists yang in the transformation of qi.

[0034] Rhodiola rosea: Sweet and cold in nature. It enters the spleen and lung meridians. It strengthens the spleen and replenishes qi, clears the lungs and relieves cough, and promotes blood circulation and removes blood stasis.

[0035] Acanthopanax bark: pungent and bitter in taste, warm in nature. It enters the liver and kidney meridians. It dispels wind and dampness, tonifies the liver and kidneys, strengthens muscles and bones, and promotes urination.

[0036] Prepared licorice root: sweet, neutral. It enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and stomach, replenishes qi and restores the pulse, and harmonizes the effects of other herbs.

[0037] The formula analysis of the traditional Chinese medicine composition described in this invention is as follows:

[0038] Explanation: Astragalus in this formula invigorates qi, strengthens the spleen, promotes diuresis, and reduces swelling; Ginseng greatly replenishes vital energy and also nourishes the qi of the heart, spleen, lungs, and kidneys, while calming the mind and improving intelligence. These two herbs work synergistically and together serve as the principal herbs. Atractylodes macrocephala excels at replenishing qi to restore spleen function and also dries dampness and promotes diuresis. Combined with Dioscorea opposita, which tonifies the spleen, lungs, and kidneys, it enhances the qi-tonifying effect; Poria cocos and Alisma plantago-aquatica promote diuresis and eliminate dampness. The combination of these three herbs further enhances the spleen-strengthening, dampness-removing, diuretic, and swelling-reducing effects; Polygonatum sibiricum nourishes yin, moistens the lungs, tonifies the spleen and kidneys, and has the effect of replenishing essence and benefiting the brain. Angelica sinensis nourishes and invigorates blood, while Ligusticum chuanxiong invigorates blood, promotes qi circulation, and relieves pain. Together, they promote the smooth flow of blood; these are all the assistant herbs. The adjuvant herbs include Ophiopogon japonicus to nourish yin and moisten the lungs, clear the heart and relieve irritability; Schisandra chinensis to astringe the lungs and generate fluids, and to stop sweating; these two herbs, when combined with ginseng, one tonifies, one clears, and one astringes, following the principle of Shengmai San (a traditional Chinese medicine formula), which can both replenish qi and nourish yin, and restore the depletion of qi and yin; Anemarrhena asphodeloides is used to treat Astragalus membranaceus, which is warm and drying, replenishing qi without causing heat, and also nourishing the fluids in the lungs; Spleen deficiency and dampness obstructing the middle jiao, with clear yang failing to ascend and turbid yin failing to descend, are combined with Citrus reticulata to regulate qi mechanism, assist in the restoration of ascending and descending, regulate qi and harmonize the stomach, so that the tonifying herbs do not cause stagnation; Cinnamomum cassia warms yang and transforms qi, and when qi is transformed, water will naturally flow, and it also works with the diuretic herbs Poria cocos, Alisma plantago-aquatica, and Atractylodes macrocephala to distribute fluids and promote water circulation; Acanthopanax senticosus warms the kidneys and promotes diuresis; Rhodiola rosea strengthens the spleen, replenishes qi, and invigorates blood and removes blood stasis. Prepared licorice root, being sweet and warm in nature, tonifies qi and harmonizes the other herbs in the formula, serving as an adjuvant. The *Medical Formulas Examination* states, "When taking Shengmai Powder, adding astragalus and licorice root will invigorate qi and strength." Therefore, combining astragalus, ginseng, ophiopogon, and schisandra here can greatly enhance the qi-tonifying effect. The combined use of these herbs achieves the effects of tonifying qi, strengthening the spleen, promoting blood circulation, and promoting diuresis.

[0039] Dosage and administration of this invention: Oral administration, one sachet (10g per sachet), twice a day, for 14 days as one course of treatment. It is recommended to take 4 courses of treatment or as directed by a physician.

[0040] The main functions and indications of this invention are: to invigorate qi and strengthen the spleen, promote blood circulation and diuresis. This invention is suitable for spleen deficiency syndrome manifested as fatigue, chest tightness, shortness of breath, edema, dizziness, palpitations, abdominal distension, poor appetite, or aversion to cold, weak or loose stools, difficulty urinating, and symptoms such as dullness, slow speech and movement, and depression. It is particularly suitable for heart failure accompanied by cognitive impairment with the above symptoms. Detailed Implementation

[0041] Example 1

[0042] A traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency syndrome comprises the following traditional Chinese medicine composition in parts by weight: Astragalus membranaceus 20 parts, Ginseng 9 parts, Atractylodes macrocephala 15 parts, Dioscorea opposita 15 parts, Poria cocos 15 parts, Alisma plantago-aquatica 10 parts, Polygonatum sibiricum 9 parts, Angelica sinensis 9 parts, Ligusticum chuanxiong 9 parts, Ophiopogon japonicus 10 parts, Anemarrhena asphodeloides 9 parts, Schisandra chinensis 6 parts, Citrus reticulata 10 parts, Cinnamomum cassia 6 parts, Rhodiola rosea 9 parts, Acanthopanax senticosus 12 parts, and Glycyrrhiza uralensis 6 parts.

[0043] A method for preparing a traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency includes the following steps:

[0044] (1) Weigh out the Chinese herbal composition by weight, add water 8 times the weight of the Chinese herbal composition and decoct for 2 hours for the first decoction, then filter to obtain the residue and the first decoction liquid.

[0045] (2) Add water equal to 8 times the weight of the Chinese herbal medicine composition to the filter residue and decoct for a second time. The second decoction is 1.5 hours. Filter to obtain the second decoction. Combine the first decoction and the second decoction to obtain the filtrate.

[0046] (3) Let the filtrate stand, take the supernatant and concentrate it at 60°C and 0.08 MPa under reduced pressure to a thick paste with a relative density of 1.3 to water; (4) Add xylitol and dextrin and mix well. The weight ratio of xylitol:dextrin:thick paste is 1:4:2. Granulate, dry, and package to obtain the final product.

[0047] Example 2

[0048] A traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency syndrome comprises the following traditional Chinese medicine composition in parts by weight: Astragalus membranaceus 18 parts, Ginseng 12 parts, Atractylodes macrocephala 14 parts, Dioscorea opposita 14 parts, Poria cocos 14 parts, Alisma plantago-aquatica 8 parts, Polygonatum sibiricum 10 parts, Angelica sinensis 10 parts, Ligusticum chuanxiong 10 parts, Ophiopogon japonicus 8 parts, Anemarrhena asphodeloides 10 parts, Schisandra chinensis 5 parts, Citrus reticulata 11 parts, Cinnamomum cassia 5 parts, Rhodiola rosea 8 parts, Acanthopanax senticosus 10 parts, and Glycyrrhiza uralensis 6 parts.

[0049] A method for preparing a traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency includes the following steps:

[0050] (1) Weigh out the Chinese herbal composition by weight, add water 8 times the weight of the Chinese herbal composition and decoct for 2 hours for the first decoction, then filter to obtain the residue and the first decoction liquid.

[0051] (2) Add water equal to 8 times the weight of the Chinese herbal medicine composition to the filter residue and decoct for a second time. The second decoction is 1.5 hours. Filter to obtain the second decoction. Combine the first decoction and the second decoction to obtain the filtrate.

[0052] (3) Let the filtrate stand, take the supernatant and concentrate it at 80°C and 0.06 MPa under reduced pressure to a thick paste with a relative density of 1.4 to water; (4) Add xylitol and dextrin and mix well. The weight ratio of xylitol:dextrin:thick paste is 1:4:2. Granulate, dry, and package to obtain the final product.

[0053] Example 3

[0054] A traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency syndrome comprises the following traditional Chinese medicine composition in parts by weight: Astragalus membranaceus 19 parts, Ginseng 11 parts, Atractylodes macrocephala 13 parts, Dioscorea opposita 13 parts, Poria cocos 13 parts, Alisma plantago-aquatica 9 parts, Polygonatum sibiricum 11 parts, Angelica sinensis 11 parts, Ligusticum chuanxiong 11 parts, Ophiopogon japonicus 9 parts, Anemarrhena asphodeloides 11 parts, Schisandra chinensis 7 parts, Citrus reticulata 12 parts, Cinnamomum cassia 7 parts, Rhodiola rosea 10 parts, Acanthopanax senticosus 11 parts, and Glycyrrhiza uralensis 6 parts.

[0055] A method for preparing a traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency includes the following steps:

[0056] (1) Weigh out the Chinese herbal composition by weight, add water 8 times the weight of the Chinese herbal composition and decoct for 2 hours for the first decoction, then filter to obtain the residue and the first decoction liquid.

[0057] (2) Add water equal to 8 times the weight of the Chinese herbal medicine composition to the filter residue and decoct for a second time. The second decoction is 1.5 hours. Filter to obtain the second decoction. Combine the first decoction and the second decoction to obtain the filtrate.

[0058] (3) Let the filtrate stand, take the supernatant and concentrate it at 70°C and 0.07 MPa under reduced pressure to a thick paste with a relative density of 1.4 to water; (4) Add xylitol and dextrin and mix well. The weight ratio of xylitol:dextrin:thick paste is 1:4:2. Granulate, dry, and package to obtain the final product.

[0059] Example 4

[0060] A traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency syndrome comprises the following traditional Chinese medicine composition in parts by weight: Astragalus membranaceus 21 parts, Ginseng 10 parts, Atractylodes macrocephala 16 parts, Dioscorea opposita 16 parts, Poria cocos 16 parts, Alisma plantago-aquatica 11 parts, Polygonatum sibiricum 12 parts, Angelica sinensis 12 parts, Ligusticum chuanxiong 12 parts, Ophiopogon japonicus 11 parts, Anemarrhena asphodeloides 12 parts, Schisandra chinensis 6 parts, Citrus reticulata 8 parts, Cinnamomum cassia 6 parts, Rhodiola rosea 11 parts, Acanthopanax senticosus 14 parts, and Glycyrrhiza uralensis (processed) 7 parts.

[0061] A method for preparing a traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency includes the following steps:

[0062] (1) Weigh out the Chinese herbal composition by weight, add water 8 times the weight of the Chinese herbal composition and decoct for 2 hours for the first decoction, then filter to obtain the residue and the first decoction liquid.

[0063] (2) Add water equal to 8 times the weight of the Chinese herbal medicine composition to the filter residue and decoct for a second time. The second decoction is 1.5 hours. Filter to obtain the second decoction. Combine the first decoction and the second decoction to obtain the filtrate.

[0064] (3) Let the filtrate stand, take the supernatant and concentrate it under reduced pressure at 75°C and 0.07 MPa to a thick paste with a relative density of 1.35 to water.

[0065] (4) Add xylitol and dextrin and mix well. The weight ratio of xylitol:dextrin:thick paste is 1:4:2. Granulate, dry, and package to obtain the final product.

[0066] Example 5

[0067] A traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency syndrome comprises the following traditional Chinese medicine composition in parts by weight: Astragalus membranaceus 22 parts, Ginseng 8 parts, Atractylodes macrocephala 17 parts, Dioscorea opposita 17 parts, Poria cocos 17 parts, Alisma plantago-aquatica 12 parts, Polygonatum sibiricum 8 parts, Angelica sinensis 8 parts, Ligusticum chuanxiong 8 parts, Ophiopogon japonicus 12 parts, Anemarrhena asphodeloides 8 parts, Schisandra chinensis 6 parts, Citrus reticulata 9 parts, Cinnamomum cassia 5 parts, Rhodiola rosea 12 parts, Acanthopanax senticosus 13 parts, and Glycyrrhiza uralensis 5 parts.

[0068] A method for preparing a traditional Chinese medicine composition for treating heart failure with cognitive impairment due to spleen deficiency includes the following steps:

[0069] (1) Weigh out the Chinese herbal composition by weight, add water 8 times the weight of the Chinese herbal composition and decoct for 2 hours for the first decoction, then filter to obtain the residue and the first decoction liquid.

[0070] (2) Add water equal to 8 times the weight of the Chinese herbal medicine composition to the filter residue and decoct for a second time. The second decoction is 1.5 hours. Filter to obtain the second decoction. Combine the first decoction and the second decoction to obtain the filtrate.

[0071] (3) Let the filtrate stand, take the supernatant and concentrate it under reduced pressure at 80°C and 0.065 MPa to a thick paste with a relative density of 1.35 to water.

[0072] (4) Add xylitol and dextrin and mix well. The weight ratio of xylitol:dextrin:thick paste is 1:4:2. Granulate, dry, and package to obtain the final product.

[0073] The efficacy of this application will be demonstrated below with the aid of case studies.

[0074] This invention relates to several clinical application case studies. To avoid leakage of patient information, some information has been hidden.

[0075] Case 1

[0076] A, male, 74 years old.

[0077] The patient was admitted to the hospital due to "recurrent chest tightness and shortness of breath for 2 months, worsening with palpitations for 1 day." The standard treatment for heart failure was combined with the herbal composition described in Example 1 of this document for 4 courses of treatment. The dosage was oral, one 10g packet twice daily, for 14 days as one course of treatment.

[0078] Admission diagnosis: Coronary artery disease, heart failure, NYHA class IV

[0079] Symptoms upon admission: recurrent chest tightness and shortness of breath, worsening with activity, palpitations, general weakness, slowed reaction time, memory loss, loss of appetite, and loose stools. The tongue was dark red with a white coating, and the pulse was deep and rapid.

[0080] Upon admission, the patient's vital signs were as follows: BNP: 2028 pg / ml; echocardiography: EF 28% FS 13%. Liver function: aspartate aminotransferase 45.1 U / L; renal function normal; cardiac enzymes: serum myoglobin 148.22 ng / mL, creatine kinase isoenzyme normal.

[0081] Montreal rating scale: 20 points

[0082] Post-treatment symptoms: No chest tightness or shortness of breath, no palpitations, no general weakness, slow reaction, or memory loss; improved appetite and normal bowel movements. Dark red tongue with white coating, and deep pulse.

[0083] Post-treatment follow-up indicators: BNP: 836.2 pg / ml; echocardiography: EF 40%; FS 24%; liver function: aspartate transferase 42 U / L; kidney function: normal.

[0084] Montreal Rating Scale: 22 points.

[0085] Case 2

[0086] B, male, 59 years old.

[0087] The patient was admitted to the hospital due to "intermittent chest tightness and pain for 10 months, worsening with palpitations for 3 days, severe for half a day". The standard treatment for heart failure was combined with the traditional Chinese medicine composition from Example 1, administered for 4 courses of treatment. Oral administration: one 10g packet at a time, twice a day, for 14 days as one course of treatment.

[0088] Admission diagnosis: Coronary artery disease, ischemic cardiomyopathy, old myocardial infarction, heart failure, NYHA Class IV.

[0089] Symptoms upon admission: chest tightness and pain, palpitations, occasional dizziness and shortness of breath, general weakness, heaviness in the limbs, depression, poor appetite, loose stools, normal urination. The tongue was pale with a white coating, and the pulse was deep and slippery.

[0090] Upon admission, the patient's vital signs were as follows: BNP: 521 pg / ml; echocardiography: EF 51% FS 27%; liver function tests: aspartate aminotransferase 10 U / L, total protein: 58.4 g / L, albumin: 35.9 g / L; kidney function tests: serum urea 2.19 mmol / L, serum β2-microglobulin: 0.96 mg / L.

[0091] Montreal Rating Scale: 24 points

[0092] Post-treatment symptoms: Good mental state, no chest tightness or pain, occasional palpitations, no dizziness or shortness of breath, general weakness relieved, limb heaviness reduced, appetite good, bowel movements normal. Pale tongue with white coating, deep and slippery pulse.

[0093] Post-treatment follow-up indicators: BNP: 67 pg / ml; echocardiography: E46%F23%FS; liver function: aspartate transferase U / L; kidney function: serum β2-microglobulin: 1.26 mg / L.

[0094] Montreal Rating Scale: 26 points.

[0095] Case 3

[0096] Ms. C, 69 years old.

[0097] The patient was admitted to the hospital due to "recurrent chest tightness, shortness of breath, and fatigue for 10 months, worsening in the past week." The standard treatment for heart failure was combined with the traditional Chinese medicine composition from Example 2, administered for 4 courses of treatment. The dosage was oral, one 10g packet twice daily, for 14 days as one course of treatment.

[0098] Admission diagnosis: Unstable angina pectoris due to coronary artery disease, heart failure, NYHA class III.

[0099] Symptoms upon admission: recurrent chest tightness and shortness of breath, aggravated by exertion, occasional palpitations, general fatigue and weakness, lethargy and reluctance to speak, normal bowel movements and urination. Dark red tongue with white coating, thready and slippery pulse.

[0100] Upon admission, the patient's vital signs were as follows: BNP: 310.3 pg / ml; echocardiography: EF% 46, FS% 27; liver function: albumin 38.7 g / L; complete blood count and renal function were normal.

[0101] Montreal Rating Scale: 24 points

[0102] Post-treatment symptoms: No chest tightness or shortness of breath, no palpitations, general weakness and reluctance to speak have lessened, bowel movements and urination are normal. Tongue is dark red with a white coating, and pulse is thready and slippery.

[0103] Post-treatment follow-up indicators: BNP: 79 pg / ml; echocardiography: EF% 58 FS%. Liver function: aspartate transferase U / L; kidney function: normal.

[0104] Montreal Rating Scale: 26 points.

[0105] Case 4

[0106] Mr. D, male, 60 years old.

[0107] The patient was admitted to the hospital due to "recurrent chest tightness, shortness of breath for one week, worsening for two days." The standard treatment for heart failure was combined with the traditional Chinese medicine composition from Example 2, administered for four courses of treatment. The dosage was oral, one 10g packet twice daily, for 14 days as one course of treatment.

[0108] Admission diagnosis: Acute ST-segment elevation myocardial infarction due to coronary artery disease, heart failure, NYHA class IV.

[0109] Symptoms upon admission: recurrent chest tightness and shortness of breath, aggravated by exertion, occasional palpitations, general fatigue and weakness, lethargy and reluctance to speak, normal bowel movements and urination. Dark red tongue with a white, greasy coating, and slippery pulse.

[0110] Upon admission, the patient's vital signs were as follows: NT-ProBNP: 7036.8 pg / ml; echocardiography: EF% 33, FS% 16. Liver function tests showed: total protein 61.4 g / L, albumin 37.3 g / L; renal function was normal.

[0111] Montreal Rating Scale: 19 points

[0112] Symptoms after treatment: no chest tightness or shortness of breath, no palpitations, general weakness and reluctance to speak have been reduced, and bowel movements and urination are normal.

[0113] Post-treatment follow-up indicators: BNP: 1800 pg / ml; echocardiography: EF% 53%, FS 27%; liver function: aspartate transferase U / L; kidney function: β2-microglobulin: 3.98 mg / L.

[0114] Montreal Rating Scale: 21 points.

[0115] Case 5

[0116] E, male, 68 years old.

[0117] The patient was admitted to the hospital due to "recurrent chest tightness and shortness of breath for 4 years, worsening with palpitations for 1 week." The standard treatment for heart failure was combined with the traditional Chinese medicine composition from Example 3, administered for 4 courses of treatment. Oral administration: one 10g packet at a time, twice daily, for 14 days as one course of treatment.

[0118] Admission diagnosis: Coronary artery disease, unstable angina, heart failure, NYHA class III

[0119] Symptoms upon admission: Dull expression, recurrent chest tightness and shortness of breath, palpitations, lethargy, belching and acid reflux, normal appetite and sleep, normal bowel movements. Dark red tongue with thin white coating, and intermittent pulse.

[0120] Upon admission, the patient's vital signs were as follows: BNP: 746.1 pg / ml; echocardiography: EF% 38% FS% 18%; liver function: total protein 64.8 g / L; kidney function: β2-microglobulin 3.24 mg / L.

[0121] Montreal Rating Scale: 19 points

[0122] Post-treatment symptoms: Good mental state, no chest tightness or shortness of breath, no palpitations, reduced lethargy and reluctance to speak, good appetite and sleep, normal bowel movements. Dark red tongue with thin white coating, intermittent pulse.

[0123] Post-treatment follow-up indicators: BNP: 256.5 pg / ml; echocardiography: EF% 53%, FS 27%; liver function: aspartate aminotransferase 45.8 U / L, alanine aminotransferase: 53.2 U / L, total protein 59.6 g / L, albumin 37.7 g / L; kidney function: β2-microglobulin: 3.05 mg / L.

[0124] Montreal Rating Scale: 21 points.

[0125] Case 6

[0126] F, male, 69 years old

[0127] The patient was admitted to the hospital due to "persistent chest tightness and pain for 8 hours, worsening for 5 hours." The standard treatment for heart failure was combined with the traditional Chinese medicine composition from Example 3, administered for 4 courses of treatment. Oral administration: one 10g packet at a time, twice daily, for 14 days as one course of treatment.

[0128] Admission diagnosis: Unstable angina pectoris due to coronary artery disease, heart failure, NYHA class II.

[0129] Symptoms upon admission: lethargy, persistent chest tightness and pain, slight shortness of breath (more pronounced when lying flat), sweating, fatigue, fair appetite, poor sleep, normal bowel movements. The tongue was dark red with a white coating, and the pulse was wiry and slippery.

[0130] Upon admission, the patient's vital signs were as follows: BNP: 181.9 pg / ml; echocardiography: EF 60% FS 33%; liver function: aspartate transferase and total protein 54.4 g / L; kidney function: creatinine 53 μmmol / L.

[0131] Montreal rating scale: 25 points

[0132] Post-treatment symptoms: Improved mental state, no chest tightness or pain, no shortness of breath, no fatigue or sweating, good appetite and sleep, normal bowel movements. Dark red tongue with white coating, wiry and slippery pulse.

[0133] Post-treatment follow-up indicators: BNP: 56.5 pg / ml; echocardiography: EF% 64%, FS 35%; liver function: aspartate transferase 14.2 U / L.

[0134] Montreal Rating Scale: 26 points.

[0135] Case 7

[0136] G, male, 80 years old.

[0137] The patient was admitted to the hospital due to "intermittent chest tightness and shortness of breath for 4 years, recurring for 1 month, worsening and accompanied by inability to lie flat for 7 days." The standard treatment for heart failure was combined with the traditional Chinese medicine composition of Example 4, administered for 4 courses of treatment. Oral administration: one 10g packet at a time, twice a day, for 14 days as one course of treatment.

[0138] Admission diagnosis: Unstable angina pectoris due to coronary artery disease, heart failure, NYHA class IV.

[0139] Symptoms upon admission: lethargy, chest tightness, shortness of breath, which worsened when lying down or moving, slight fatigue, abdominal distension, poor appetite, oliguria, normal bowel movements. Dark red tongue with a thin white coating, and a deep, thready pulse.

[0140] Upon admission, the patient's vital signs were as follows: NT-proBNP: 35000 pg / ml; echocardiography: EF% 43% FS% 21%; liver function: total bilirubin 27.7 g / L, total protein 61.6 g / L, albumin 32.7 g / L; kidney function: serum urea: 9.62 mmol / L.

[0141] Montreal Rating Scale: 19 points

[0142] Post-treatment symptoms: Improved mental state, no chest tightness, shortness of breath, fatigue relieved, no abdominal distension, reduced appetite but slightly increased food intake, normal bowel movements. Dark red tongue with thin white coating, intermittent pulse.

[0143] Post-treatment follow-up indicators: NT-proBNP: 18000 pg / ml; echocardiography: EF% 48%, FS 25%; liver function: aspartate aminotransferase 44.5 U / L, albumin 37.7 g / L; kidney function: serum urea: 6.2 mmol / L.

[0144] Montreal rating scale: 20 points.

[0145] Case 8

[0146] Ms. H, 70 years old

[0147] The patient was admitted to the hospital due to "persistent chest pain for 8 hours." The standard treatment for heart failure was combined with the traditional Chinese medicine composition from Example 4, administered for 4 courses of treatment. The dosage was oral, one 10g packet twice daily, for 14 days as one course of treatment.

[0148] Admission diagnosis: Unstable angina pectoris due to coronary artery disease, heart failure, NYHA class IV.

[0149] Symptoms upon admission: persistent chest pain radiating to the back, chest tightness, shortness of breath, inability to lie flat, fatigue, memory loss, good appetite, poor sleep, normal bowel movements. Dark red tongue with a thin white coating, and a thready, rapid pulse.

[0150] Upon admission, the patient's vital signs were as follows: BNP: 1594.9 pg / ml; echocardiography: EF% 55% FS% 29%. Liver function: aspartate aminotransferase 50 U / L; kidney function: serum urea: 8.04 mmol / L, creatinine 98 μmmol / L.

[0151] Montreal Rating Scale: 22 points

[0152] Post-treatment symptoms: Good mental state, no chest tightness or pain, no shortness of breath or palpitations, reduced general weakness, decreased memory, good appetite, poor sleep, normal bowel movements. Dark red tongue with thin white coating, thready and rapid pulse.

[0153] Post-treatment follow-up indicators: BNP: 326.7 pg / ml; echocardiography: EF% 55%, FS 29%; liver function: aspartate aminotransferase 44.5 U / L, albumin 37.7 g / L; kidney function: serum urea: 11.36 mmol / L, creatinine 105 μmmol / L.

[0154] Montreal Rating Scale: 24 points.

[0155] Case 9

[0156] I, male, 42 years old

[0157] The patient was admitted to the hospital due to "recurrent chest tightness and shortness of breath for 10 years, with a recurrence lasting 2 hours." The standard treatment for heart failure was combined with the traditional Chinese medicine composition from Example 5, administered for 4 courses of treatment. The dosage was oral, one 10g packet twice daily, for 14 days as one course of treatment.

[0158] Admission diagnosis: Dilated heart disease, heart failure, NYHA Class IV

[0159] Symptoms upon admission: persistent chest tightness, shortness of breath, orthopnea, irritability, depression, general weakness, nausea, vomiting, edema of both lower extremities, poor appetite and sleep, oliguria, and normal bowel movements. The tongue was pale with a thin white coating, and the pulse was deep and slippery.

[0160] Upon admission, the patient's vital signs were as follows: BNP: 1057.6 pg / ml; echocardiography: EF% 22, FS% 10. Liver and kidney function tests were normal.

[0161] Montreal rating scale: 25 points

[0162] Post-treatment symptoms: No chest tightness, wheezing, or shortness of breath; general weakness relieved; no restlessness; no swelling in both lower limbs; good appetite and sleep; normal bowel movements and urination. Dark red tongue with a thin white coating; thready and rapid pulse.

[0163] Post-treatment follow-up indicators: BNP: 463.2 pg / ml; echocardiography: EF% 25, ​​FS 12%. Liver and kidney function: normal.

[0164] Montreal Rating Scale: 28 points.

[0165] Case 10

[0166] Ms. J, 78 years old

[0167] The patient was admitted to the hospital due to "recurrent chest tightness and palpitations for 20 years." The standard treatment for heart failure was combined with the traditional Chinese medicine composition from Example 5, administered for four courses of treatment. The dosage was oral, one 10g packet twice daily, for 14 days as one course of treatment.

[0168] Admission diagnosis: Coronary artery disease, heart failure, NYHA class IV

[0169] Symptoms upon admission: recurrent chest tightness and palpitations, restlessness, sweating during attacks, shortness of breath after activity, occasional dizziness, sluggish speech and movement, poor appetite, poor sleep, constipation, normal urination, pale tongue, thin white coating, and deep and thready pulse.

[0170] Upon admission, the patient's vital signs were as follows: BNP: 3422 pg / ml; echocardiography: EF% 54%, FS% 35%. Kidney function: creatinine 115 μmmol / L; liver function: normal.

[0171] Montreal Rating Scale: 21 points

[0172] Post-treatment symptoms: No episodes of chest tightness or palpitations, significant reduction in mental agitation, no shortness of breath or sweating, occasional dizziness, slow and weak speech and movement, good appetite and sleep, normal bowel movements. Dark red tongue with a thin white coating, thready and rapid pulse.

[0173] Post-treatment follow-up indicators: BNP: 1200 pg / ml; echocardiography: EF% 58, FS 37%. Liver and kidney function: normal.

[0174] Montreal Rating Scale: 23 points.

[0175] The embodiments described above are merely some, not all, of the embodiments of this application. The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit this application or its application or use. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

Claims

1. A traditional Chinese medicine composition for treating heart failure with spleen deficiency, characterized in that, The traditional Chinese medicine is made from the following ingredients by weight: Radix Astragali 18-22 parts, Radix Ginseng 8-12 parts, Rhizoma Atractylodis Macrocephalae 13-17 parts, Rhizoma Dioscoreae 13-17 parts, Poria 13-17 parts, Rhizoma Alismatis 8-12 parts, Rhizoma Polygonati 8-12 parts, Radix Angelicae Sinensis 8-12 parts, Rhizoma Chuanxiong 8-12 parts, Radix Ophiopogonis 8-12 parts, Rhizoma Anemarrhenae 8-12 parts, Fructus Schisandrae 5-7 parts, Pericarpium Citri Reticulatae 8-12 parts, Ramulus Cinnamomi 5-7 parts, Rhodiolae Crenulatae 8-12 parts, Cortex Radicis Acanthopanacis Senticosi 10-14 parts, and Radix Glycyrrhizae Preparata 5-7 parts. 2.The traditional Chinese medicine composition for treating heart failure with spleen deficiency according to claim 1, characterized in that, The traditional Chinese medicine is made from the following ingredients by weight: Radix Astragali 20 parts, Radix Ginseng 9 parts, Rhizoma Atractylodis Macrocephalae 15 parts, Rhizoma Dioscoreae 15 parts, Poria 15 parts, Rhizoma Alismatis 10 parts, Rhizoma Polygonati 9 parts, Radix Angelicae Sinensis 9 parts, Rhizoma Chuanxiong 9 parts, Radix Ophiopogonis 10 parts, Rhizoma Anemarrhenae 9 parts, Fructus Schisandrae 6 parts, Pericarpium Citri Reticulatae 10 parts, Ramulus Cinnamomi 6 parts, Rhodiolae Crenulatae 9 parts, Cortex Radicis Acanthopanacis Senticosi 12 parts, and Radix Glycyrrhizae Preparata 6 parts.

3. The preparation method of the traditional Chinese medicine composition for treating heart failure with spleen deficiency syndrome according to claim 1, characterized in that, The method comprises the following steps: (1) weighing the traditional Chinese medicine composition, and decocting the traditional Chinese medicine composition in 8 times the weight of water for the first time for 2 hours to obtain filtrate residue and first decocting liquid; (2) adding the filtrate residue into 8 times the weight of water of the traditional Chinese medicine composition to decoct for the second time for 1.5 hours to obtain second decocting liquid, and combining the first decocting liquid and the second decocting liquid to obtain filtrate; (3) placing the filtrate, and concentrating the supernatant under reduced pressure to a thick paste with a relative density of 1.3-1.4; (4) adding xylitol and dextrin, mixing, granulating, drying, and dispensing to obtain the product.

4. The preparation method of the traditional Chinese medicine composition for treating heart failure with spleen deficiency syndrome according to claim 3, characterized in that, In step (3), the relative density is the density of the thick paste relative to water at 60°C.

5. The preparation method of the traditional Chinese medicine composition for treating heart failure with spleen deficiency syndrome according to claim 3, characterized in that, In step (3), the temperature for the reduced pressure concentration is 60-80°C, and the pressure is 0.06-0.08 Mpa.

6. The preparation method of the traditional Chinese medicine composition for treating heart failure with spleen deficiency syndrome according to claim 3, characterized in that, In step (4), the weight ratio of xylitol:dextrin:thick paste is 1:4:2.