Traditional Chinese medicine composition for treating double-heart disease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating double heart diseases and a preparation method and application thereof. The traditional Chinese medicine composition for treating the double-heart disease comprises the following active pharmaceutical ingredients in parts by mass: 3-10 parts of cassia twig, 10-15 parts of poria with hostwood, 3-10 parts of pericarpium citri reticulatae, 10-15 parts of salvia miltiorrhiza, 6-10 parts of rhizoma cyperi, 6-12 parts of glossy privet fruit, 6-15 parts of radix paeoniae alba, 9-30 parts of codonopsis pilosula and 10-15 parts of spina date seed. Clinical tests show that after the traditional Chinese medicine composition is adopted for treatment, the heart function core index of a patient with the double-heart disease is remarkably improved, the psychological state core scale score shows breakthrough improvement, the life quality scale display is comprehensively improved, and the occurrence rate of overall adverse reactions and adverse events is low. Therefore, the traditional Chinese medicine composition is remarkable in clinical curative effect and good in safety.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating double heart disease and a preparation method and application thereof. BACKGROUND

[0002] Double heart disease refers to a disease state of a heart disease patient accompanied by emotional disorders such as anxiety and depression. Recent research shows that the incidence of double heart disease is between 24% and 40%, which is significantly higher than that of other heart diseases and is 4 to 5 times that of the general population. However, in China, the management and treatment of double heart disease patients still have deficiencies, especially in the identification and treatment of psychological disorders. Contemporary cardiovascular experts have proposed the concept of 'Psycho-Cardiology', which emphasizes that the mental and psychological state of a patient should also be concerned while treating heart disease. For patients with emotional disorders, psychological treatment should be performed. At present, western medicine treatment mainly relies on mental drugs to control the mental state, but these drugs may cause side effects and complications, for example, patients taking escitalopram antidepressants may experience side effects such as headache, nausea, sexual dysfunction, insomnia and fatigue.

[0003] Traditional Chinese medicine, based on the overall concept and the characteristics of individualized syndrome differentiation and treatment, can play an important role in the diagnosis and treatment of double heart disease, has advantages such as precision, individualization and fewer adverse reactions, and has a good application prospect. However, most of the traditional Chinese medicine compounds for treating double heart disease do not start from the overall perspective and do not consider the dynamic balance of viscera, so that the treatment is not complete and the treatment effect is poor. Therefore, it is necessary to start from the overall perspective and develop a traditional Chinese medicine composition which can effectively treat double heart disease to meet the clinical drug demand. SUMMARY

[0004] The first object of the present application is to provide a traditional Chinese medicine composition for treating double heart disease, the second object of the present application is to provide a preparation method of the traditional Chinese medicine composition, and the third object of the present application is to provide the application of the traditional Chinese medicine composition.

[0005] According to the first aspect of the present application, a traditional Chinese medicine composition for treating double heart disease is provided, and the effective components include the following raw medicinal materials in mass parts: cassia twig 3-10 parts, bezoar 10-15 parts, dried tangerine or orange peel 3-10 parts, salvia miltiorrhiza 10-15 parts, cyperus 6-10 parts, female privet fruit 6-12 parts, white peony root 6-15 parts, codonopsis 9-30 parts, and sour jujube seed 10-15 parts.

[0006] The present application considers that double heart disease is caused by deficiency of heart and spleen yang qi, blood stasis, and deficiency of heart spirit. Heart governs blood vessels, and heart yang qi is needed to warm and promote blood circulation to nourish the whole body. Deficiency of heart yang qi cannot promote blood circulation, and blood stasis causes chest tightness and chest pain. Deficiency of spleen qi causes failure of transportation and transformation, deficiency of qi and blood, shortness of breath, lack of strength, less food and body fatigue. Yang qi is the essence of spirit, and now yang qi deficiency and blood stasis cause spirit deficiency, memory loss, depression, and palpitation. Deficiency of heart and spleen causes pale tongue and weak pulse. Blood stasis and qi stagnation cause purple tongue and string pulse. The treatment should warm heart yang, supplement spleen qi, promote blood circulation, and calm the mind.

[0007] The present application considers that double heart disease is caused by deficiency of heart and spleen yang qi, blood stasis, and deficiency of heart spirit. Heart governs blood vessels, and heart yang qi is needed to warm and promote blood circulation to nourish the whole body. Deficiency of heart yang qi cannot promote blood circulation, and blood stasis causes chest tightness and chest pain. Deficiency of spleen qi causes failure of transportation and transformation, deficiency of qi and blood, shortness of breath, lack of strength, less food and body fatigue. Yang qi is the essence of spirit, and now yang qi deficiency and blood stasis cause spirit deficiency, memory loss, depression, and palpitation. Deficiency of heart and spleen causes pale tongue and weak pulse. Blood stasis and qi stagnation cause purple tongue and string pulse. The treatment should warm heart yang, supplement spleen qi, promote blood circulation, and calm the mind.

[0008] In the prescription, cassia twig is acrid, sweet and warm, which can warm yang, dredge blood vessels, and supplement deficiency. The Dayuazibencao states that it can supplement five kinds of overstrain and seven kinds of injury, dredge nine orifices, and remove blood stasis. Codonopsis root can supplement qi and invigorate spleen. The Bencaozhengyi states that it can supplement spleen and stomach, and invigorate middle qi. It is sweet and flat, which is especially neutral, and it can supplement middle qi without the side effect of dryness. The combination of the two drugs can warm heart yang to dredge blood vessels, supplement spleen qi to assist transformation, and serve as the monarch drug. Blood stasis and qi stagnation can be removed by salvia miltiorrhiza and cyperus rotundus, which can also activate blood and promote qi. Heart spirit deficiency can be treated by zizyphus jujuba and poria cocos, which can nourish blood and calm the mind. Ligustrum lucidum and paeonia lactiflora are both cold in nature, which can nourish yin and calm the mind, and can prevent the side effect of cassia twig and cyperus rotundus. They can also dredge qi and blood. Chenpi can regulate qi and blood, which can assist cyperus rotundus to promote qi and remove stagnation, and make other drugs supplement without stagnation. The combination of the drugs is acrid and warm without dryness, supplements deficiency without stagnation, and combines hardness and softness, which is a perfect combination of the prescription, and can warm yang, supplement qi, dredge blood vessels, and calm the mind.

[0009] The raw materials of the present application are as follows: Cassia twig: the tender branch of Cinnamomum cassia Presl. It is acrid, sweet and warm, and belongs to heart, lung and bladder meridians.

[0010] Poria cocos: the white part of Poria cocos (Schw.) Wolf. It is sweet and flat, and belongs to heart and spleen meridians.

[0011] Pericarpium Citri Reticulatae: The dried mature fruiting body of Citrus reticulata Blanco and its cultivated varieties. It is acrid and bitter in taste and warm in nature. It is attributed to the spleen and lung meridians.

[0012] Salvia miltiorrhiza Bge. of the Labiatae family. It is bitter in taste and cold in nature. It is attributed to the heart and liver meridians.

[0013] Cyperus rotundus L. of the Cyperaceae family. It is acrid, bitter and slightly sweet in taste and neutral in nature. It is attributed to the liver, spleen and triple energ meridians.

[0014] Ligustrum lucidum Ait. of the Oleaceae family. It is sweet and bitter in taste and cool in nature. It is attributed to the liver and kidney meridians.

[0015] Paeonia lactiflora Pall. of the Ranunculaceae family. It is bitter and sour in taste and cold in nature. It is attributed to the liver and spleen meridians.

[0016] Codonopsis pilosula (Franch.) Nannf., C. pilosula Nannf. var. (Nannf.) L. T. Shen or C. tangshen Oliv. of the Campanulaceae family.

[0017] Ziziphus jujuba Mill. var. spinosa (Bunge) Huex H.F.Chou of the Rhamnaceae family. It is sweet and sour in taste and neutral in nature. It is attributed to the liver, gallbladder and heart meridians.

[0018] In some embodiments, the effective components include the following mass parts of raw medicinal materials: 5 parts of cassia twig, 15 parts of bezoar, 5 parts of pericarpium citri reticulatae, 10 parts of salvia miltiorrhiza, 9 parts of cyperus rotundus, 9 parts of ligustrum lucidum, 9 parts of paeonia lactiflora, 15 parts of codonopsis pilosula, and 15 parts of zizyphus jujuba.

[0019] In some embodiments, the effective components further include the following mass parts of at least one of the raw medicinal materials: 9-15 parts of prunella vulgaris, 15-30 parts of ranunculus arvensis, 6-12 parts of angelica sinensis, 9-15 parts of morinda officinalis, 3-10 parts of ligusticum wallichii, 3-5 parts of centipede, 3-9 parts of atractylodes lancea, 3-12 parts of phellodendron amurense, 3-10 parts of agastache rugosa, and 3-10 parts of pterocephalus hispidus.

[0020] Generally, if the liver yang hyperactivity manifestations such as headache, irritability and other manifestations are seen, the Herba Prunellae and Radix Polygoni Multiflori can be added to dredge liver meridians and discharge liver fire; if the liver blood deficiency manifestations such as dry eyes, and sallow complexion are seen, the Angelica sinensis and Caulis Spatholobi can be added to nourish liver and blood; if the serious manifestations of blood stasis in collaterals such as sallow complexion, and pulse stenosis are seen, the Ligusticum chuanxiong and Scorpio can be added to activate blood and dredge collaterals; if the manifestations of thick and greasy sputum such as obesity, and white and slippery tongue fur are seen, the Rhizoma Atractylodis and Cortex Phellodendri can be added to strengthen the power of eliminating sputum, or the Agastache rugosa and Perilla frutescens can be added to aromatic and turbid to awaken the spleen.

[0021] In some embodiments, pharmaceutically acceptable excipients can also be added.

[0022] In some embodiments, the excipients are at least one of solvents, propellants, solubilizers, co-solvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, and preservatives.

[0023] In some embodiments, the dosage form of the traditional Chinese medicine composition is a decoction, an oral solution, a powder, a tablet, a capsule, a granule, a pill, or a dripping pill.

[0024] According to a second aspect of the present application, a preparation method of the above traditional Chinese medicine composition is provided, when the dosage form of the traditional Chinese medicine composition is a decoction, the preparation method comprises the following steps: The raw medicinal materials are mixed according to the proportion, soaked in 8-10 times of water by weight for 30-60 minutes, then boiled with a large fire for 10-20 minutes, and then boiled with a small fire for 15-30 minutes, and then filtered to obtain the medicinal liquid, concentrated to 1g crude drug / mL, and added with excipients to prepare the corresponding dosage form according to the conventional method in the art.

[0025] According to a third aspect of the present application, a preparation method of the above traditional Chinese medicine composition is provided, when the dosage form of the traditional Chinese medicine composition is an oral solution, a powder, a tablet, a capsule, a granule, a pill, or a dripping pill, the preparation method comprises the following steps: The raw medicinal materials are mixed according to the proportion, soaked in 8-10 times of water by weight for 30-60 minutes, then boiled with a large fire for 10-20 minutes, and then boiled with a small fire for 15-30 minutes, and then filtered to obtain the medicinal liquid, concentrated to 1g crude drug / mL, and added with excipients to prepare the corresponding dosage form according to the conventional method in the art.

[0026] According to a fourth aspect of the present application, the use of the above traditional Chinese medicine composition for treating double heart disease in the preparation of a medicine for treating double heart disease is provided.

[0027] The beneficial effects of the present application include: (1) The present application is directed to the treatment of double heart disease. The double heart disease is often based on stubborn old illness, and the qi-blood-yin-yang of five viscera is often obviously unbalanced. The liver and spleen qi movement is unbalanced, and the constitution is characterized by being real with phlegm and blood stasis. The present application starts from "carefully checking five viscera, and focusing on liver and spleen", emphasizes the dynamic balance of viscera, and takes into account the treatment of phlegm and blood stasis. The traditional Chinese medicine composition of the present application aims to realize the dynamic balance among viscera by clearing and nourishing heart, regulating lung, warming and tonifying primordial yang, warming kidney to receive qi, and protecting spleen and stomach and nourishing liver, and taking into account the treatment of phlegm and blood stasis. The traditional Chinese medicine composition of the present application can not only invigorate the spleen and tonify qi, but also soothe liver and regulate qi and remove blood stasis, so as to regulate the function of five viscera by regulating the spleen and liver, so as to improve the life quality of double heart disease patients and reduce the harm of disease. The traditional Chinese medicine composition of the present application is mainly used for treating heart-spleen yang deficiency, blood stasis, and heart spirit deficiency syndrome, which is manifested as palpitation, chest distress, shortness of breath, dizziness, drowsiness, insomnia, forgetfulness, depression, pale purple tongue, thin white coating, and thin weak pulse.

[0028] (2) Clinical trials show that after treatment with the traditional Chinese medicine composition of the present application, the core indicators of heart function of double heart disease patients are significantly improved, and the paired t test proves that the improvement of heart function has statistical significance; the core scale score of psychological state shows a breakthrough improvement, and the psychological improvement after treatment reaches an extremely significant level; the life quality scale shows all-round improvement after treatment, and the improvement of life quality after treatment has statistical extremely significant; the overall adverse reactions and adverse events have low incidence. It shows that the traditional Chinese medicine composition of the present application has significant clinical efficacy and good safety. DETAILED DESCRIPTION

[0029] The present application will be further described in detail below in combination with specific examples. Unless otherwise specified, the raw materials and reagents used in the present application are commercially available.

[0030] Example 1 The traditional Chinese medicine decoction for treating double heart disease of the present embodiment is prepared from the following raw medicinal materials: cassia twig 5g, poria 15g, dried tangerine or orange peel 5g, salvia miltiorrhiza 10g, cyperus 9g, ligustrum lucidum 9g, white peony root 9g, radix codonopsis 15g, and sour jujube seed 15g.

[0031] The preparation method comprises the following steps: Mix the raw medicinal materials according to the ratio, soak in 10 times weight of water for 50 minutes, then boil with large fire for 15 minutes, and then keep boiling with small fire for 20 minutes.

[0032] The traditional Chinese medicine decoction prepared in the present embodiment is a single dose, and the single dose is about 200mL.

[0033] Example 2 The oral solution for treating dual heart disease in this embodiment is prepared from the following raw materials: 10g cinnamon twig, 15g Poria cocos, 3g dried tangerine peel, 10g Salvia miltiorrhiza, 6g Cyperus rotundus, 6g Ligustrum lucidum, 15g white peony root, 30g Codonopsis pilosula, and 10g Ziziphus jujuba var. spinosa.

[0034] Its preparation method includes the following steps: The medicinal liquid was obtained according to the method for preparing the decoction in Example 1. The medicinal liquid was concentrated to 1g crude drug / mL, excipients were added, and it was prepared into an oral solution according to conventional methods in the art. The obtained oral solution was sealed and stored in 10mL bottles. When taking it, one bottle was taken three times a day.

[0035] Example 3 The granules for treating dual heart disease in this embodiment are prepared from the following raw materials: 3g cinnamon twig, 10g Poria cocos, 10g dried tangerine peel, 15g Salvia miltiorrhiza, 10g Cyperus rotundus, 12g Ligustrum lucidum, 6g white peony root, 9g Codonopsis pilosula, and 15g Ziziphus jujuba var. spinosa.

[0036] Its preparation method includes the following steps: The medicinal liquid was obtained according to the method for preparing the decoction in Example 1. The medicinal liquid was concentrated to 1g crude drug / mL, excipients were added, and granules were prepared according to conventional methods in the art. The obtained granules were divided into 10g packets, sealed and stored. When taking the medicine, one packet was taken twice a day.

[0037] To illustrate the therapeutic effect of the traditional Chinese medicine composition for treating dual heart disease of the present invention on dual heart disease, the following clinical trials were conducted.

[0038] I. Test Subjects 1. Inclusion criteria (1) Applicants must be between 18 and 75 years old, regardless of gender; (2) Meets the diagnostic criteria for chronic heart failure, and vital signs are stable; (3) Hamilton Anxiety Rating Scale score, 14 points ≤ score < 29 points; (4) PHQ-9≤9 points; (5) The patient agrees to participate in this trial and signs an informed consent form.

[0039] 2. Exclusion criteria (1) Patients with poorly controlled hypertension (systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥100 mmHg). (2) Patients with poor blood glucose control (glycated hemoglobin > 7.9%); (3) Pregnant or breastfeeding women; (4) Patients with severe renal insufficiency or hepatic insufficiency (ALP > 405 U / L, or glomerular filtration rate < 30 ml / min). (5) Patients with concurrent malignant tumors; (6) Patients with concurrent severe hematopoietic system diseases; (7) Patients with comorbid primary anxiety disorder or other mental health disorders; (8) Patients with cognitive impairment such as Alzheimer's disease or cerebral infarction; (9) Patients whom the researchers deem unsuitable for enrollment.

[0040] Based on the above criteria, 30 qualified subjects were selected.

[0041] II. Test Methods 1. Treatment plan (1) Basic medications: ① Diuretics; ② Renin-angiotensin system inhibitors (RASI); ③ β-blockers; ④ Aldosterone receptor antagonists (MRA); ⑤ Sodium-glucose cotransporter 2 inhibitors (SGLT2i); ⑥ Soluble guanylate cyclase (sGC) stimulants; ⑦ Ivabradine; ⑧ Digitalis preparations.

[0042] (2) The traditional Chinese medicine decoction for treating dual heart disease prepared in Example 1 is taken once a day, twice a day after lunch and dinner, while warm. It is taken continuously for 2 weeks.

[0043] (3) Psychological Counseling: ① Humanized Nursing. Medical staff should proactively communicate with patients in a warm and friendly manner, introduce the ward and surrounding environment, and gain the patients' trust with steady and skillful operations. At the same time, they should use methods such as suggestion, persuasion, demonstration, and guidance to help patients learn to relax and shift their attention, eliminate psychological factors of tension, and make patients feel trust and security in medical staff. They should patiently explain their inner doubts, help them adjust their mentality, and enhance their confidence in overcoming the disease. ② Emotional Counseling. Nurses should develop different nursing plans for each patient and provide targeted counseling for the patients' negative emotions. They should emphasize the importance of psychological factors in the treatment of chronic heart failure and help them maintain a positive and optimistic attitude. For anxious patients, they should patiently explain the knowledge of chronic heart failure, so that they can correctly understand the disease, stabilize their emotions, eliminate doubts, and consciously cooperate with treatment and nursing. For worried patients, they should use encouraging words to communicate and relieve their negative influences. At the same time, they should combine some successful clinical cases to inform patients that as long as they cooperate with treatment with a positive and optimistic attitude, they can effectively improve the treatment effect and correct their fear and depression. ③ When necessary, a psychologist should be consulted to assess and guide relevant psychological counseling.

[0044] In addition to basic medication, all patients received the traditional Chinese medicine decoction for treating dual heart disease prepared in Example 1, along with psychological counseling, for a period of 2 weeks.

[0045] 2. Combined medication (1) During the trial, all patients were treated with heart failure as a base and discontinued other non-basic medications, including both Chinese and Western medicines. If patients were already taking beta-blockers, they were to maintain the original dose without increasing it. It was forbidden to add or increase any Chinese or Western medicines with the same efficacy as the test drug.

[0046] (2) During the clinical trial, it is permissible to retain the Chinese and Western medicines in other chronic disease treatment plans, but the trade name, chemical name (referring to Western medicine), usage and dosage, course of treatment, etc. of the combined Chinese and Western medicines must be specified and remain unchanged throughout the entire clinical trial.

[0047] (3) Record the name of the combined medication used, the total daily dosage, the reason for use, and the start and end times of use for each follow-up visit.

[0048] (4) Please also record any medications used in combination for other diseases in accordance with the above requirements.

[0049] III. Results of Therapeutic Effect Evaluation 1. Patient baseline characteristics and distribution of comorbidities Patient baseline characteristics and distribution of comorbidities are shown in Table 1.

[0050] Table 1. Baseline characteristics and distribution of comorbidities of patients

[0051] As shown in Table 1, this study included 30 patients with dual heart disease, with a mean age of 68.4 ± 12.3 years. Males accounted for 70% (21 cases), while females had a higher mean age (73.8 ± 7.2 years). The predominant baseline comorbidities were hypertension (83.3%) and diabetes (56.7%), with a slightly higher proportion of hypertension in males than females (85.7% vs 77.8%). All patients initially had a cardiac function classification of 93.3% / 6.7%. Four patients had a history of allergies but did not experience drug-related allergic reactions, indicating a good baseline safety profile for treatment.

[0052] 2. Comparison of core cardiac function indicators before and after treatment The results of comparing the core cardiac function indicators before and after treatment are shown in Table 2.

[0053] Table 2 Comparison of core cardiac function indicators before and after treatment ( ±s)

[0054] Table 2 shows that the core indicators of cardiac function significantly improved after treatment: the ejection fraction increased from 62.67±10.453 at baseline to 68.87±3.748 after treatment, and the reduced dispersion (standard deviation decreased from 10.453 to 3.748) indicates improved stability of the therapeutic effect. The NT-ProBNP level decreased significantly from 1030±284.7647 ng / L to 589.3±144.1914 ng / L, a decrease of 42.8%, suggesting that myocardial load and the risk of heart failure were effectively reduced after treatment.

[0055] 3. Intra-group comparison of the differences in core cardiac function indicators before and after treatment The results of intragroup comparisons of the differences in core cardiac function indicators before and after treatment are shown in Table 3.

[0056] Table 3. Intragroup comparison of differences in core cardiac function indicators before and after treatment (paired t-test)

[0057] Note: The above data uses the difference between the indicators from DAY1 to DAY14 as the test statistic.

[0058] As shown in Table 3, the paired t-test confirmed that the improvement in cardiac function was statistically significant: the difference in ejection fraction was -6.200 (p<0.001, t=-4.203), and the difference in NT-ProBNP was 440.7 (p<0.001, t=4.055). Notably, the improvement in NT-ProBNP exceeded the clinical threshold (>300 ng / L), and no cases of reversal deterioration occurred, demonstrating that the treatment had a clear cardioprotective effect.

[0059] 4. Comparison of scores on the core psychological state scale before and after treatment The results of the comparison of the scores of the core psychological state scale before and after treatment are shown in Table 4.

[0060] Table 4 Comparison of scores on the core psychological state scale before and after treatment ( ±s)

[0061] As shown in Table 4, the scores on the core psychological scales showed breakthrough improvement after treatment: the Hamilton Depression Rating Scale (HAMD) score decreased from 26.00±3.017 to 5.03±1.402, and the Hamilton Anxiety Rating Scale (HAMA) score decreased from 25.33±3.032 to 7.80±2.905. Both HAMD and HAMA scores were below the clinical diagnostic thresholds (HAMD < 7 points, HAMA < 14 points) after treatment, indicating that the patients achieved clinical recovery in their psychological state after treatment.

[0062] 5. Intra-group comparison of the degree of improvement in psychological state indicators The results of the intragroup comparison of the degree of improvement in psychological state indicators are shown in Table 5.

[0063] Table 5. Within-group comparison results of the degree of improvement in psychological state indicators (paired t-test)

[0064] Note: The above data uses the difference between the indicators from DAY1 to DAY14 as the test statistic.

[0065] As shown in Table 5, the psychological improvement after treatment was highly significant: the difference in HAMD was 20.967±2.798 (t=41.050, p<0.001), and the difference in HAMA was 17.533±2.403 (t=39.963, p<0.001). The standard deviations of both HAMD and HAMA differences were less than 3 points, indicating a high degree of consistency in the treatment effects.

[0066] 6. Multidimensional evaluation of quality of life changes before and after treatment The results of the multidimensional evaluation of quality of life before and after treatment are shown in Table 6.

[0067] Table 6. Changes in quality of life before and after treatment (Multidimensional assessment) ±s)

[0068] As shown in Table 6, the quality of life scales improved comprehensively after treatment: the Kansas City Cardiomyopathy Quality of Life Questionnaire (KCCQ) score increased from 68.77±16.76 to 91.70±5.11, the Minnesota Heart Failure Quality of Life Questionnaire (MLHFQ) score decreased from 64.33±10.91 to 26.63±8.54, and the WHOQOL-BREF score increased from 28.53±5.88 to 65.30±4.46. The improvement on all scales exceeded the minimum clinically significant differences (e.g., KCCQ ≥ 5 points, MLHFQ ≥ 10 points), confirming the practical significance of the treatment.

[0069] 7. Intergroup comparison of the degree of improvement in quality of life indicators The intergroup comparison results of the degree of improvement in quality of life indicators are shown in Table 7.

[0070] Table 7. Intergroup comparison of the degree of improvement in quality of life indicators (paired t-test)

[0071] Note: The above data uses the difference between the indicators from DAY1 to DAY14 as the test statistic.

[0072] Table 7 shows that the improvement in quality of life after treatment was statistically significant: KCCQ difference -22.933 (p<0.001, t=-9.991), MLHFQ difference 37.700 (p<0.001, t=32.367), WHOQOL-BREF difference -36.767 (p<0.001, t=-44.977). Baseline comorbidities (hypertension, diabetes) did not significantly affect the extent of improvement (p>0.05), suggesting that the treatment remains safe and effective in complex comorbid populations.

[0073] IV. Safety Evaluation Results One patient experienced elevated transaminase levels during treatment. After switching to a domestically produced lipid-lowering drug, the patient improved upon medication and follow-up examination; clinical experts considered this unrelated to the intervention. Another patient experienced elevated creatinine levels due to heart failure-induced renal failure; this improved after drug treatment and follow-up examination; clinical experts considered this unrelated to the intervention. Laboratory safety indicators for the remaining patients showed no significant abnormalities.

[0074] The overall incidence of adverse reactions and adverse events was low, and most of them were mild. None of the subjects withdrew from the clinical study and continued treatment or resumed medication after a period of suspension.

[0075] The above research results show that the traditional Chinese medicine composition of the present invention has significant clinical efficacy and good safety.

Claims

1. A traditional Chinese medicine composition for treating double heart disease, characterized in that, The effective components include the following mass parts of raw medicinal materials: cassia twig 3-10 parts, bezoar 10-15 parts, dried tangerine or orange peel 3-10 parts, red sage root 10-15 parts, cyperus 6-10 parts, female privet fruit 6-12 parts, white peony root 6-15 parts, codonopsis 9-30 parts, and sour jujube seed 10-15 parts.

2. The traditional Chinese medicine composition for treating double heart disease according to claim 1, characterized in that, The effective components include the following mass parts of raw medicinal materials: cassia twig 5 parts, bezoar 15 parts, dried tangerine or orange peel 5 parts, red sage root 10 parts, cyperus 9 parts, female privet fruit 9 parts, white peony root 9 parts, codonopsis 15 parts, and sour jujube seed 15 parts.

3. The traditional Chinese medicine composition for treating double heart disease according to claim 1 or 2, characterized in that, The effective components further include at least one of the following mass parts of raw medicinal materials: prunella 9-15 parts, catclaw grass 15-30 parts, angelica 6-12 parts, luffa 9-15 parts, chuanxiong 3-10 parts, centipede 3-5 parts, atractylodes 3-9 parts, amur cork-tree 3-12 parts, agastache 3-10 parts, and pellitory 3-10 parts.

4. The traditional Chinese medicine composition for treating double heart disease according to claim 1 or 2, characterized in that, A pharmaceutically acceptable adjuvant can be further added.

5. The traditional Chinese medicine composition for treating double heart disease according to claim 4, characterized in that, The adjuvant is at least one of a solvent, a propellant, a solubilizer, a cosolvent, an emulsifier, a coloring agent, a binder, a disintegrant, a filler, a lubricant, and a preservative.

6. The traditional Chinese medicine composition for treating double heart disease according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is a decoction, an oral solution, a powder, a tablet, a capsule, a granule, a pill, or a dripping pill.

7. The method for preparing the traditional Chinese medicine composition for treating double heart disease according to any one of claims 1-6, characterized in that, When the dosage form of the traditional Chinese medicine composition is a decoction, the preparation method includes the following steps: The raw medicinal materials are mixed according to the ratio, soaked in 8-10 times the weight of water for 30-60 minutes, then boiled with a large fire for 10-20 minutes, and then kept slightly boiling with a small fire for 15-30 minutes.

8. The method for preparing the traditional Chinese medicine composition for treating double heart disease according to any one of claims 1-6, characterized in that, When the dosage form of the traditional Chinese medicine composition is an oral solution, a powder, a tablet, a capsule, a granule, a pill, or a dripping pill, the preparation method includes the following steps: The raw medicinal materials are mixed according to the ratio, soaked in 8-10 times the weight of water for 30-60 minutes, then boiled with a large fire for 10-20 minutes, and then kept slightly boiling with a small fire for 15-30 minutes, filtered after decoction, concentrated to 1 g crude drug / mL, added with an adjuvant, and prepared into a corresponding dosage form.

9. Use of the traditional Chinese medicine composition for treating double heart disease according to any one of claims 1-6 in the preparation of a medicine for treating double heart disease.

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