Traditional Chinese medicine composition for treating ejection fraction preserved heart failure and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for treating ejection fraction reserved heart failure. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 28-32 parts of radix rehmanniae preparata, 7-11 parts of deer-horn glue, 1-5 parts of cinnamon, 1-4 parts of blast-fried ginger charcoal, 4-8 parts of semen brassicae, 1-4 parts of ephedra, 7-11 parts of processed rhizoma pinelliae, 13-17 parts of angelica sinensis and 1-5 parts of raw liquorice. The invention further provides application of the traditional Chinese medicine composition. According to the whole formula, yang warming and blood replenishing are combined, phlegm and turbidity are reduced, blood collaterals are dredged, yang deficiency can be tonified, nutrient blood can be filled, phlegm and turbidity and blood stasis can be removed, the kidney can be warmed, essence can be enriched, yang can be assisted to cure the root, and pungent-warm phlegm reducing and collateral dredging can cure the symptom. The Yang and modified prescription is combined with conventional western medicines for treatment, so that the traditional Chinese medicine clinical syndromes of heart failure patients with reserved ejection fraction due to Yang deficiency and turbid phlegm can be remarkably improved, the NT-proBNP level of serum is reduced, the life quality is improved, and the traditional Chinese medicine composition is safe in clinical application, has certain clinical value and is worthy of further research and popularization.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction and application thereof. Background Art

[0002] Heart failure with preserved ejection fraction (HFpEF) is a complex clinical syndrome characterized by decreased cardiac diastolic function and compliance rather than decreased systolic function. Although the left ventricular ejection fraction is ≥50%, patients also have typical symptoms of heart failure, including exercise intolerance, decreased quality of life, dyspnea, edema, and cough.

[0003] Chinese patent document CN111991449A discloses a Chinese medicine composition for preventing and treating heart failure with preserved ejection fraction, wherein the Chinese medicine composition is obtained by extracting crude drugs, and the crude drugs include Poria cocos, cinnamon twig, Atractylodes macrocephala and red peony root. The preparation method includes two parts: modern process and traditional process. The modern process extracts volatile oils of cinnamon twig and Atractylodes macrocephala by ethanol and water, prepares inclusion compound, and mixes with the extract of four medicinal materials. The traditional process is traditional decoction with water, and the volatile oils of cinnamon twig and Atractylodes macrocephala are prepared into volatile oil-cyclodextrin molecular complex, which is mixed with the extract made of water extract of four medicinal materials.

[0004] Chinese patent document CN116173132A discloses the use of a Chinese medicine composition in the preparation of a medicine for treating heart aging, the Chinese medicine composition is composed of Cuscuta, Lycium barbarum, Schisandra chinensis, Cnidium monnieri, Rosa laevigata, Allium chinense, Morinda officinalis, Cistanche deserticola, Radix Rehmanniae, Cyathula officinalis, Epimedium, Rubus idaeus, Ginseng, Pilose antler, Hippocampus, and Toosendan fruit. The test results show that the medicine of the present invention can significantly reduce the collagen content of myocardial tissue in HFpEF rats, reduce the degree of myocardial fibrosis, inhibit left ventricular remodeling, thereby improving rat cardiac function, preventing and treating heart failure with preserved ejection fraction, and having a significant effect in treating heart aging.

[0005] There are many traditional Chinese medicine compositions for treating and preventing heart failure with preserved ejection fraction, but they all have more or less disadvantages, such as too many medicinal ingredients, difficult to obtain materials, expensive prices, unclear efficacy, poor therapeutic effect, etc. Therefore, there is an urgent need for a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction that has obvious efficacy, few medicinal ingredients, is practical, highly compliant, safe and effective. Summary of the invention

[0006] The purpose of the present invention is to provide a Chinese medicine composition for treating heart failure with preserved ejection fraction and its application in view of the deficiencies in the prior art.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating heart failure with preserved ejection fraction, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 28-32 parts of cooked rehmannia, 7-11 parts of antler glue, 1-5 parts of cinnamon, 1-4 parts of roasted ginger charcoal, 4-8 parts of white mustard seeds, 1-4 parts of ephedra, 7-11 parts of processed pinellia, 13-17 parts of angelica, and 1-5 parts of raw licorice.

[0008] As a preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 29-31 parts of cooked rehmannia, 8-10 parts of antler glue, 2-4 parts of cinnamon, 1-3 parts of roasted ginger charcoal, 5-7 parts of white mustard seeds, 1-3 parts of ephedra, 8-10 parts of processed pinellia, 14-16 parts of angelica, and 2-4 parts of raw licorice.

[0009] As another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 30 parts of cooked rehmannia, 9 parts of antler glue, 3 parts of cinnamon, 2 parts of roasted ginger charcoal, 6 parts of white mustard seeds, 2 parts of ephedra, 9 parts of processed pinellia, 15 parts of angelica, and 3 parts of raw licorice.

[0010] As another preferred example, the Chinese medicine composition is in the form of tablets, capsules, granules, oral liquids or syrups.

[0011] In a second aspect, the present invention provides use of a traditional Chinese medicine composition in preparing a medicament for treating heart failure with preserved ejection fraction.

[0012] As a preferred example, the heart failure with preserved ejection fraction is heart failure with preserved ejection fraction due to yang deficiency and phlegm turbidity syndrome.

[0013] The advantages of the present invention are as follows: the treatment principle of the present invention is to warm the kidney and benefit the essence, resolve phlegm and dredge the meridians. The compatibility relationship of the present invention is as follows: the prescription reuses Rehmannia glutinosa to warm and nourish the blood, and is compatible with antlers, which are the product of blood and flesh, to nourish yang and blood to treat the root cause, and they are the main medicines. Roasted ginger charcoal enters the blood, warms the meridians and dispels cold, and cinnamon is good at replenishing fire, assisting yang and dispelling cold. The two medicines are used together to warm and dredge the meridians, break yin and restore yang, and are the ministerial medicines; ephedra dispels cold and promotes yang, and white mustard is pungent and warm, and can search and remove the skin and membrane to resolve hidden phlegm. The two medicines help ginger and cinnamon to dispel cold stagnation, processed pinellia enhances the function of resolving phlegm turbidity, and angelica enhances the effect of unblocking blood and collaterals, and enhances the function of promoting blood circulation and unblocking collaterals. They are combined as adjuvants, and raw licorice is used as a messenger to adjust the medicines. In the formula, antler glue and Rehmannia glutinosa are combined with roasted ginger charcoal, cinnamon, white mustard, ephedra, and processed pinellia to promote circulation, thus replenishing without stagnation; hemp, mustard, ginger, and cinnamon are combined with Rehmannia glutinosa, antler glue, and angelica to nourish, thus warming and dispersing without hurting the body. The whole formula warms the yang and replenishes the blood, and resolves phlegm and turbidity while unblocking blood channels, thus replenishing yang deficiency, replenishing blood, and removing phlegm and turbidity and blood stasis. It can warm the kidney, benefit the essence, and assist yang to treat the root cause, and resolve phlegm and dredge channels to treat the symptoms.

[0014] The Yanghe Jiawei prescription of the present invention combined with conventional western medicine treatment can significantly improve the clinical symptoms of traditional Chinese medicine in patients with heart failure with preserved ejection fraction due to yang deficiency and phlegm turbidity syndrome, reduce serum NT-proBNP levels, and improve the quality of life. It is safe in clinical application, has certain clinical value, and is worthy of further research and promotion. DETAILED DESCRIPTION

[0015] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0016] Example 1 A Chinese medicine composition for treating heart failure with preserved ejection fraction (I)

[0017] 30 parts of cooked rehmannia, 9 parts of antler glue, 3 parts of cinnamon, 2 parts of roasted ginger charcoal, 6 parts of white mustard seeds, 2 parts of ephedra, 9 parts of processed pinellia, 15 parts of angelica, and 3 parts of raw liquorice.

[0018] Example 2 A Chinese medicine composition for treating heart failure with preserved ejection fraction (II)

[0019] 30 parts of cooked rehmannia, 8 parts of antler glue, 4 parts of cinnamon, 1 part of roasted ginger charcoal, 8 parts of white mustard seeds, 2 parts of ephedra, 8 parts of processed pinellia, 16 parts of angelica, and 1 part of raw liquorice.

[0020] Example 3 A Chinese medicine composition for treating heart failure with preserved ejection fraction (III)

[0021] 29 parts of cooked rehmannia, 10 parts of antler glue, 1 part of cinnamon bark, 4 parts of roasted ginger charcoal, 6 parts of white mustard seeds, 1 part of ephedra, 10 parts of processed pinellia, 13 parts of angelica, and 5 parts of raw liquorice.

[0022] Example 4 A Chinese medicine composition for treating heart failure with preserved ejection fraction (IV)

[0023] 31 parts of cooked rehmannia, 7 parts of antler glue, 5 parts of cinnamon bark, 2 parts of roasted ginger charcoal, 5 parts of white mustard seeds, 3 parts of ephedra, 7 parts of processed pinellia, 17 parts of angelica, and 3 parts of raw liquorice.

[0024] Example 5 A Chinese medicine composition for treating heart failure with preserved ejection fraction (V)

[0025] 28 parts of cooked rehmannia, 11 parts of antler glue, 3 parts of cinnamon, 1 part of roasted ginger charcoal, 7 parts of white mustard seeds, 1 part of ephedra, 11 parts of processed pinellia, 15 parts of angelica, and 2 parts of raw liquorice.

[0026] Example 6 A Chinese medicine composition for treating heart failure with preserved ejection fraction (VI)

[0027] 32 parts of cooked rehmannia, 9 parts of antler glue, 2 parts of cinnamon bark, 3 parts of roasted ginger charcoal, 4 parts of white mustard seeds, 4 parts of ephedra, 9 parts of processed pinellia, 14 parts of angelica, and 4 parts of raw liquorice.

[0028] Example 7 A Chinese medicine composition for treating heart failure with preserved ejection fraction (VII)

[0029] 30 parts of cooked rehmannia, 10 parts of antler glue, 1 part of cinnamon bark, 4 parts of roasted ginger charcoal, 6 parts of white mustard seeds, 1 part of ephedra, 10 parts of processed pinellia, 13 parts of angelica, and 5 parts of raw liquorice.

[0030] Example 8 A Chinese medicine composition for treating heart failure with preserved ejection fraction (VIII)

[0031] 29 parts of cooked rehmannia, 7 parts of antler glue, 5 parts of cinnamon bark, 2 parts of roasted ginger charcoal, 5 parts of white mustard seeds, 3 parts of ephedra, 7 parts of processed pinellia, 17 parts of angelica, and 3 parts of raw liquorice.

[0032] Example 9 A Chinese medicine composition for treating heart failure with preserved ejection fraction (IX)

[0033] 31 parts of cooked rehmannia, 11 parts of antler glue, 3 parts of cinnamon bark, 1 part of roasted ginger charcoal, 7 parts of white mustard seeds, 1 part of ephedra, 11 parts of processed pinellia, 15 parts of angelica, and 2 parts of raw liquorice.

[0034] Example 10 A Chinese medicine composition for treating heart failure with preserved ejection fraction (X)

[0035] 28 parts of cooked rehmannia, 9 parts of antler glue, 2 parts of cinnamon bark, 3 parts of roasted ginger charcoal, 4 parts of white mustard seeds, 4 parts of ephedra, 9 parts of processed pinellia, 14 parts of angelica, and 4 parts of raw liquorice.

[0036] Example 11 A Chinese medicine composition for treating heart failure with preserved ejection fraction (XI)

[0037] 32 parts of cooked rehmannia, 8 parts of antler glue, 4 parts of cinnamon, 1 part of roasted ginger charcoal, 8 parts of white mustard seeds, 2 parts of ephedra, 8 parts of processed pinellia, 16 parts of angelica, and 1 part of raw liquorice.

[0038] Example 12 Preparation of a Chinese medicine decoction for treating heart failure with preserved ejection fraction

[0039] The method for preparing the Chinese medicine decoction of the present invention comprises the following steps: according to the weight ratio (any one of Examples 1-11), weighing an appropriate amount of the drug composition, mixing and then crushing, mixing the various components of the drug with water and heating and extracting, the heating and extracting comprises decocting with high heat and then decocting with low heat, decocting twice, combining the decoctions, filtering out the drug residues, and obtaining an extracted drug solution, which is the decoction.

[0040] Example 13 Preparation of a Chinese medicine composition granule for treating heart failure with preserved ejection fraction

[0041] The method for preparing the Chinese medicine granules of the present invention comprises the following steps: according to the weight ratio (any one of Examples 1-11), weighing an appropriate amount of the drug composition, mixing and then breaking, mixing the various components of the drug with water and performing heating extraction, the heating extraction comprises decocting with high heat and then decocting with low heat, decocting twice, combining the decoctions, filtering out the drug residues, obtaining an extraction liquid, concentrating the extraction liquid to a thick paste, drying, crushing into fine powder, adding an appropriate amount of powdered sugar and dextrin, mixing, adding ethanol to make a soft material, granulating, drying, and granulating to obtain the Chinese medicine granules.

[0042] Example 14 Clinical Trial

[0043] (1) Case collection: Clinical patients with heart failure with preserved ejection fraction and yang deficiency and phlegm turbidity syndrome were included in the study according to the diagnostic criteria for heart failure with preserved ejection fraction and the TCM diagnostic criteria for heart failure with yang deficiency and phlegm turbidity syndrome. The specific diagnostic criteria and scheme are as follows:

[0044] 1) Diagnostic criteria

[0045] Developed with reference to the "Guidelines for the Diagnosis and Treatment of Heart Failure in China 2018"

[0046] ① Typical symptoms and / or signs of heart failure (it is necessary to exclude that the patient's symptoms are caused by non-cardiac diseases);

[0047] ②Left ventricular ejection fraction (LVEF) ≥50%;

[0048] ③ Elevated natriuretic peptide (B-type natriuretic peptide (BNP)>35ng / L or N-terminal pro-B-type natriuretic peptide (NT-proBNP)>125ng / L);

[0049] ④ The presence of one or more of the following: left ventricular hypertrophy and / or left atrial enlargement, abnormal cardiac diastolic function.

[0050] 2) TCM Syndrome Differentiation Standards

[0051] According to the "Expert Consensus on the Diagnosis and Treatment of Chronic Heart Failure with Integrated Traditional Chinese and Western Medicine", the compound syndrome types of Yang deficiency syndrome and phlegm turbidity syndrome are formed, and the "Chinese Internal Medicine" is proposed:

[0052] Key points for differentiation of heart failure-yang deficiency and phlegm turbidity syndrome:

[0053] Main symptoms: palpitations, shortness of breath, chest tightness, and fatigue.

[0054] Secondary symptoms: chills and cold limbs; pale complexion; cough with sputum; abdominal distension; poor appetite.

[0055] Tongue and pulse: pale, fat or with teeth marks, white and greasy tongue coating, pulse: deep, thin or slippery. If the patient has two main symptoms and two secondary symptoms, combined with tongue and pulse, the diagnosis can be made.

[0056] 3) Inclusion criteria

[0057] ①Meet the diagnostic criteria for heart failure with preserved ejection fraction;

[0058] ②Meet the diagnostic criteria of heart failure-yang deficiency and phlegm turbidity syndrome in traditional Chinese medicine;

[0059] ③ Heart function class II-III (NYHA classification);

[0060] ④Age ≥18 and ≤80 years old, regardless of gender;

[0061] ⑤ The subjects gave their informed consent to participate in this study, signed the informed consent form and were able to cooperate with the treatment.

[0062] 4) Exclusion criteria

[0063] ① Patients with severe heart failure, heart function grade IV or acute myocardial infarction;

[0064] ② Patients with chronic obstructive pulmonary disease and hypotension;

[0065] ③ Patients with cardiogenic shock, atrial fibrillation, severe ventricular arrhythmia, cardiac tamponade, hypertrophic obstructive cardiomyopathy, acute myocarditis, severe heart valve disease with hemodynamic instability, pulmonary embolism, uncontrolled malignant hypertension, and obvious infection;

[0066] ④ Patients with severe diseases of the liver, kidney, hematopoietic system, and endocrine system;

[0067] ⑤ Patients with malignant tumors;

[0068] ⑥ Those with mental disorders and unwilling to cooperate;

[0069] ⑦ Pregnant, lactating women or women who want to have children;

[0070] ⑧People with allergic constitution or allergic to the drugs used.

[0071] (2) Clinical grouping and medication method: This study was divided into 2 groups

[0072] 1) Experimental group: conventional western medicine treatment + Yanghe decoction granules, continuous treatment for 4 weeks

[0073] Yanghe Decoction with modified granules: 30g of cooked rehmannia, 9g of deer antler glue, 3g of cinnamon, 2g of roasted ginger charcoal, 6g of white mustard seeds, 2g of ephedra, 9g of processed pinellia, 15g of angelica, and 3g of raw licorice.

[0074] The drug is light brown to brown granules with a slightly bitter taste. It is produced by Jiangyin Tianjiang Pharmaceutical Co., Ltd. Usage and Dosage: Take once in the morning and evening, 1 bag each time, and take with boiled water half an hour after a meal.

[0075] 2) Control group: conventional western medicine treatment + placebo granules, continuous treatment for 4 weeks

[0076] Placebo granules: The main ingredients include maltodextrin, lactose, and food coloring. The placebo was prepared by Jiangyin Tianjiang Pharmaceutical Co., Ltd. and made into granules according to modern pharmaceutical technology and placebo standard preparation technology. The outer packaging, color, smell, shape, etc. are as similar as possible to Yanghe Decoction Granules. Usage and dosage are the same as those of the experimental group.

[0077] Conventional Western medicine treatment drugs: Both the experimental group and the control group referred to the recommendations of the 2018 Chinese Heart Failure Guidelines. Western medicine treatment included basic treatments such as ANRI / ACEI / ARB, β-blockers, and diuretics. Western medicine is the medicine that patients usually take.

[0078] (3) Statistical analysis

[0079] After summarizing the data collected in this study, statistical analysis was performed using the statistical software SPSS26.0.

[0080] (1) Quantitative data (such as age, height, weight, etc.) are generally analyzed using parametric tests. If the data conform to the normal distribution and meet the homogeneity of variance, t-test or analysis of variance can be used. The research results are expressed in tables as mean ± standard deviation. For description; if the data conform to the normal distribution but do not meet the variance homogeneity, use the corrected t-test or non-parametric test (such as Mann-Whitney U test, Kruskal-Wallis test, etc.), and the research results are described in the table using the second quartile (first quartile, third quartile), that is, Q2 (Q1, Q3); if the data do not conform to the normal distribution, use a non-parametric test, and the research results are also described in the table using Q2 (Q1, Q3).

[0081] (2) Count data (such as gender, presence of hypertension, comparison of rates, etc.) are generally tested using the chi-square test (i.e., X 2 Test), the results are tabulated using ratios (n1:n2), proportions (n / N 总 ) or ratio (%).

[0082] (3) The graded data (such as “significantly effective, effective, ineffective, aggravated”, etc.) were statistically analyzed using nonparametric tests.

[0083] (4) The data in this study were analyzed using two-sided tests. When P < 0.05, the difference was considered statistically significant; otherwise, it was not statistically significant.

[0084] (4) Experimental results

[0085] ① Characteristics of participants

[0086] A total of 132 patients with HFpEF with Yang deficiency and phlegm turbidity were included in this study. Patient compliance was good during treatment. One patient dropped out of the control group due to refusal of laboratory tests and follow-up, one patient dropped out of the experimental group due to discontinuation of medication after fever caused by infection with the new coronavirus, and one patient dropped out due to travel to other places and unable to cooperate with follow-up. A total of 129 patients had complete data, including 65 in the control group and 64 in the experimental group.

[0087] Before treatment, the basic data of the two groups (gender, age, disease course, height, weight, BMI, NYHA heart function classification, comorbidities and concomitant medications, etc.) were sorted out, and the corresponding statistical methods were used for analysis and comparison. The results showed that there was no significant difference in the above basic data between the control group and the experimental group included in the study (P>0.05), and the baselines of the two groups were balanced and comparable.

[0088] ②Main efficacy results--TCM syndrome efficacy

[0089] The total effective rate of TCM syndrome efficacy in the control group was 55.38%, and the total effective rate of TCM syndrome efficacy in the experimental group was 85.94%. Among the 65 cases in the control group, 2 cases (3.07%) were markedly effective, 34 cases (52.30%) were effective, 21 cases (32.30%) were ineffective, and 8 cases (12.31%) were aggravated; among the 64 cases in the experimental group, 10 cases (15.62%) were markedly effective, 45 cases (70.31%) were effective, 7 cases (10.94%) were ineffective, and 2 cases (3.13%) were aggravated. There was a statistically significant difference in the total effective rate of TCM syndrome efficacy between the two groups, indicating that the total effective rate of the treatment group was better than that of the control group, as shown in Table 1. The TCM syndrome efficacy of the experimental group was higher than that of the control group.

[0090] Table 1 Comparison of efficacy of TCM syndromes [cases (%)]

[0091]

[0092] Note: Compared with the control group, △ P<0.05.

[0093] ③ Comparison of serum NT-proBNP

[0094] Before treatment, there was no statistically significant difference in NT-proBNP levels between the two groups of patients by two independent sample T-test (P>0.05), indicating that the two groups were comparable.

[0095] After treatment, the NT-proBNP levels in the control group and the experimental group were compared with those before treatment, and the differences were statistically significant (P<0.01) by paired sample T test.

[0096] After treatment, the NT-proBNP levels of the control group and the experimental group were compared between the two groups, and the two independent sample T test showed statistical difference (P<0.01), indicating that the experimental group was superior to the control group in improving the NT-proBNP level. See Table 2.

[0097] Table 2 Comparison of NT-proBNP (pg / ml)]

[0098]

[0099] Note: Compared with the same group before treatment, ** P<0.01; compared with the control group after treatment, △△ P<0.01.

[0100] ④Comparison of Minnesota Quality of Life Scale scores

[0101] Before treatment, the difference in the Minnesota Quality of Life Scale scores between the two groups of patients was compared by two independent sample T test, and there was no statistical difference (P>0.05), indicating that the two groups were comparable.

[0102] After treatment, the Minnesota Quality of Life Scale scores of the control group and the experimental group were compared with those before treatment, and the paired sample T test showed that the differences were statistically significant (P<0.01).

[0103] After treatment, the scores of the Minnesota Quality of Life Scale in the control group and the experimental group were compared between the two groups. The two-independent sample T test showed statistically significant differences (P<0.05), indicating that the experimental group was superior to the control group in improving the scores of the Minnesota Quality of Life Scale. See Table 3.

[0104] Table 3 Comparison of Minnesota Quality of Life Scale scores [ (point)]

[0105]

[0106] Note: Compared with the same group before treatment, ** P<0.01; compared with the control group after treatment, △ P<0.05.

[0107] ⑤Safety assessment

[0108] A total of 3 adverse events occurred during the study. One patient in the control group experienced mild nausea, which was relieved after rest and did not recur. No other measures were taken and the patient did not withdraw from the study. One patient developed fever, and laboratory tests showed that he was infected with the new coronavirus. The patient took antiviral drugs on his own and the symptoms were relieved, and he withdrew from the study. One patient in the experimental group had mild loose stools, which was considered to be related to eating cold drinks. The symptoms were relieved after adjusting the diet structure, and there was no recurrence during the period, so the patient did not withdraw from the study. No drug-related adverse reactions such as fever, rash, allergies, nausea, and vomiting were observed during the study. Adverse reaction events have been recorded in detail in the CRF form. After analysis, the above adverse reactions are not related to the medication used in this study. Among the three patients with adverse reactions, only one patient in the control group who was infected with the new coronavirus withdrew from the study.

[0109] Before and after treatment and during the follow-up period, the body temperature, heart rate, blood pressure and other vital signs of the two groups of patients were normal; blood routine, liver and kidney function (ALT, AST, Scr, BUN, UA), electrolytes (K + 、Na + , Cl - ) and other safety indicators showed no obvious abnormalities. This suggests that Yanghe Jiawei Fang is safe and reliable for heart failure with preserved ejection fraction.

[0110] (5) Research conclusions

[0111] The Yanghe Jiawei prescription of the present invention combined with conventional western medicine treatment can significantly improve the clinical symptoms of traditional Chinese medicine in patients with heart failure with preserved ejection fraction due to yang deficiency and phlegm turbidity syndrome, reduce serum NT-proBNP levels, and improve the quality of life. It is safe in clinical application, has certain clinical value, and is worthy of further research and promotion.

[0112] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating heart failure with preserved ejection fraction, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 28-32 parts of cooked rehmannia, 7-11 parts of antler glue, 1-5 parts of cinnamon bark, 1-4 parts of roasted ginger charcoal, 4-8 parts of white mustard seeds, 1-4 parts of ephedra, 7-11 parts of processed pinellia, 13-17 parts of angelica, and 1-5 parts of raw licorice.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 29-31 parts of cooked rehmannia, 8-10 parts of antler glue, 2-4 parts of cinnamon bark, 1-3 parts of roasted ginger charcoal, 5-7 parts of white mustard seeds, 1-3 parts of ephedra, 8-10 parts of processed pinellia, 14-16 parts of angelica, and 2-4 parts of raw licorice.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of cooked rehmannia, 9 parts of antler glue, 3 parts of cinnamon bark, 2 parts of roasted ginger charcoal, 6 parts of white mustard seeds, 2 parts of ephedra, 9 parts of processed pinellia, 15 parts of angelica, and 3 parts of raw licorice.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The medicine of the Chinese medicine composition is tablet, capsule, granule, oral liquid or syrup.

5. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating heart failure with preserved ejection fraction.

6. The use according to claim 5, characterized in that: The heart failure with preserved ejection fraction is heart failure with preserved ejection fraction due to yang deficiency and phlegm turbidity syndrome.

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