Use of a traditional Chinese medicine composition in preparing a drug for preventing or treating diabetic cardiomyopathy

Abstract

The present invention discloses the use of a traditional Chinese medicine composition in the preparation of a drug for preventing or treating diabetic cardiomyopathy. The traditional Chinese medicine composition of the present invention is composed of notopterygium root, angelica dahurica, Poria cocos, saposhnikovia root, schizonepeta tenuifolia, ligusticum wallichii, chuanxiong rhizome, platycodon grandiflorum, bupleurum root, peucedanum chinense, fructus aurantii, and liquorice. Pharmacodynamic experimental results show that the traditional Chinese medicine composition of the present invention can reduce serum creatine kinase isoenzyme (CK-MB) and lactate dehydrogenase (LDH) levels, and can significantly improve diabetic myocardial cell damage; reduce cardiac index, improve myocardial hypertrophy and left ventricular remodeling, and has the effect of preventing and treating diabetic cardiomyopathy.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and the present invention relates to a new use of a traditional Chinese medicine composition, and specifically to the use of a traditional Chinese medicine composition in preparing a drug for preventing or treating diabetic cardiomyopathy. Background Art

[0002] Diabetic cardiomyopathy (DCM) refers to a specific myocardial disease that occurs in patients with diabetes and cannot be explained by hypertensive heart disease, coronary atherosclerotic cardiomyopathy, valvular heart disease, or other heart diseases. Diabetic cardiomyopathy is one of the major complications of diabetes. The disease is characterized by decreased cardiac function and myocardial hypertrophy. Long-term development can also lead to myocardial fibrosis and heart failure.

[0003] Current treatment for diabetic cardiomyopathy focuses on controlling blood sugar and blood pressure, improving various metabolic abnormalities, and using beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor antagonists to maintain the condition. Long-term use of Western medications can have significant side effects and is incurable, leaving patients suffering from the effects of the disease.

[0004] Diabetic cardiomyopathy is the main cause of complications and death in diabetic patients, but there is currently no effective drug for treating diabetic cardiomyopathy. Therefore, it is particularly important to research and develop a drug to prevent and treat diabetic cardiomyopathy.

[0005] Traditional Chinese Medicine considers diabetic cardiomyopathy to fall under the categories of "thirstiness," "chest pain," "palpitations," "restlessness," and "insomnia." The primary pathogenesis is lung, spleen, and kidney deficiency, which leads to dryness and heat, continuously depleting Qi and damaging Yin, which in turn affects the heart, causing Qi and Yin depletion, damage to the heart, obstruction of the heart meridians, and restlessness. Furthermore, spleen deficiency, which leads to the internal generation of phlegm and dampness, can also lead to obstruction of the heart meridians. However, there is no evidence that Jingfang Baidu San is used for diabetic cardiomyopathy.

[0006] The Jingfang Baidu San formula, originating from Zhang Shiche's "Shesheng Zhong Miao Fang" (Miscellaneous Prescriptions for Health Preservation) from the Ming Dynasty, is a derivative of the Ginseng Baidu San from the official Song Dynasty medical text "Taiping Huimin Hejiju Fang" (Prescriptions for the Heji Bureau), minus the ginseng and the herbs Schizonepeta tenuifolia and Saposhnikovia divaricata. Jingfang Granules and Jingfang Mixture utilize modern Chinese medicine techniques to refine Jingfang Baidu San. They are primarily used clinically for colds, headaches, body aches, aversion to cold without sweating, nasal congestion, clear runny nose, and cough with white sputum. Jingfang Granules are also effective in treating flat warts, urticaria, and itchy skin. However, Jingfang Baidu San has not been used for diabetic cardiomyopathy. Summary of the Invention

[0007] The purpose of the present invention is to provide a Chinese medicine composition for preventing or treating diabetic cardiomyopathy. In order to achieve the above purpose, the technical solution adopted in this application is as follows:

[0008] A traditional Chinese medicine composition for preventing or treating diabetic cardiomyopathy, comprising the following components in parts by weight:

[0009]

[0010]

[0011] Furthermore, the Chinese medicine composition is made of the following components in parts by weight:

[0012]

[0013] Furthermore, the preparation form of the Chinese medicine composition is tablets, capsules, pills, granules, mixtures, and powders;

[0014] Furthermore, the oral preparation is a mixture.

[0015] Furthermore, the oral preparation is a granule.

[0016] The diabetic cardiomyopathy is selected from type 1 diabetic cardiomyopathy or type 2 diabetic cardiomyopathy.

[0017] The Chinese medicine composition of the present invention can be prepared by the following preparation process:

[0018] Step A: distilling and extracting volatile oil from Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium wilfordii, Angelica dahurica, Peucedanum chinense, Chuanxiong rhizome, and Fructus Aurantii Immaturus for later use; and using the distilled medicinal residues and the distilled Chuanxiong rhizome and Fructus Aurantii Immaturus aqueous solution for later use;

[0019] Step B: Prepare a 25% ethanol solution with the distilled Chuanxiong and Citrus aurantium aqueous solution obtained in step A for later use;

[0020] Step C: Poria cocos, the distilled Chuanxiong rhizome and the Fructus Aurantii Immaturus residue obtained in Step A are mixed, and the mixture is percolated with the ethanol solution obtained in Step B, and the percolation solution is set aside;

[0021] Step D: adding water to bupleurum, platycodon, liquorice, and the distilled schizonepeta, siler, notopterygium, angelica dahurica, and peucedanum scutellariae residues obtained in step A and decocting the decoction into a thick paste for later use;

[0022] Step E: The percolate obtained in step C and the thick paste obtained in step D are mixed, concentrated into a clear paste, and the volatile oil obtained in step A is added to obtain the product.

[0023] The present invention relates to the use of a traditional Chinese medicine composition in the preparation of a medicament for treating diabetic cardiomyopathy. The composition has been found to reduce serum creatine kinase isoenzyme (CK-MB) and lactate dehydrogenase (LDH) levels in rats, lower cardiac index, and significantly improve myocardial hypertrophy. Pharmacodynamic experimental results suggest that the composition has therapeutic effects on diabetic cardiomyopathy. DETAILED DESCRIPTION

[0024] In order to better illustrate the purpose, technical solutions and beneficial effects of the present invention, the present invention will be further described in detail below with reference to embodiments.

[0025] Effects of Chinese medicine combination on diabetic cardiomyopathy model rats

[0026] 1. Materials

[0027] 1.1 Animals:

[0028] Male SD rats, SPF grade, weighing 150-180 g, were acclimated in the animal room for one week with free access to water and food, adequate lighting and ventilation, 12 hours of light and 12 hours of dark, a test room temperature of 20-26°C, and a relative humidity of 46% ± 6%.

[0029] 1.2 Drugs and reagents

[0030] Jingfang extract, provided by Shandong New Era Pharmaceutical Co., Ltd., batch number: 8022009004;

[0031] Volatile oil, provided by Shandong New Era Pharmaceutical Co., Ltd., batch number: 8032009004;

[0032] Streptozotocin was purchased from BioFrox, batch number: V900890-1G.

[0033] 2 Experimental process

[0034] 2.1 Animal grouping, modeling, and drug administration

[0035] Rats were fed an adaptive diet for one week. Ten normal rats were randomly selected as the control group and fed a standard rat diet for the duration of the experiment. The remaining rats were fed a high-fat, high-sugar diet (containing 4% cholesterol, 10% fat, 5% sugar, and 81% basal diet) for eight consecutive weeks. All rats in the control group, except the control group, received a single intraperitoneal injection of 60 mg / kg of streptozotocin (STZ) to establish a diabetic model. One week later, blood glucose was measured via the tail vein. A successful diabetic model was considered established when blood glucose ≥16.7 mmol / L. Forty rats with successful modeling were selected and fed a high-sugar, high-fat diet for another four weeks. Color Doppler ultrasound revealed cardiac dysfunction, indicating successful diabetic cardiomyopathy modeling. After four weeks, the 40 rats were randomly divided into four groups: a model group, and low-, medium-, and high-dose Jingfang groups, with 10 rats in each group. The low-, medium-, and high-dose Jingfang groups were given Jingfang extract (containing volatile oil) at 2 g / kg, 4 g / kg, and 6 g / kg daily by gavage, dissolved in purified water. Administration continued for eight consecutive weeks. The Jingfang extract (containing volatile oil) is prepared by mixing the clear paste and volatile oil in the preparation process according to the ratio of clear paste: volatile oil = 1 kg: 1.8 mL.

[0036] 2.2 Observation indicators

[0037] 2.2.1 Determination of serum creatine kinase isoenzyme (CK-MB) and lactate dehydrogenase (LDH) levels in rats

[0038] After 8 weeks of administration, the rats were anesthetized by intraperitoneal injection of 10% chloral hydrate, and blood was collected through the abdominal aorta. The serum levels of creatine kinase isoenzyme (CK-MB) and lactate dehydrogenase (LDH) in the rats of each group were determined by flow cytometry.

[0039] 2.2.2 Determination of Heart Mass Index (HW / BW) and Left Ventricular Mass Index (LVW / BW) in Rats

[0040] After blood collection, the rat heart tissue was quickly removed on ice, the excess tissue was freed, and the rat heart tissue was washed with pre-cooled PBS (phosphate buffered saline) and dried with filter paper. The rat heart mass (HW) was weighed, the left ventricle was isolated and the left ventricular mass (LVW) was weighed, and the heart mass index HW / BW (heart mass / body mass) and left ventricular mass index LVW / BW (left ventricular mass / body mass) were calculated.

[0041] 2.3 Statistical analysis

[0042] SPSS 22.0 software was used for statistical analysis, and the experimental data were expressed as “mean ± standard deviation”. The data were expressed as . One-way analysis of variance was used for comparison between groups, and t-test was used for comparison between two groups. P < 0.05 indicated statistically significant differences.

[0043] 3. Results and Conclusions

[0044] 3.1 Effects of Chinese herbal medicine combination on serum creatine kinase isoenzyme (CK-MB) and lactate dehydrogenase (LDH) in rats with streptozotocin-induced diabetic cardiomyopathy model

[0045] Table 1 Effects of Chinese herbal medicine combination on serum CK-MB and LDH levels in rats with diabetic cardiomyopathy induced by streptozotocin ( n=10)

[0046]

[0047] Note: Compared with the normal control group *P<0.05, **P<0.01; compared with the model group # P<0.05, ## P<0.01.

[0048] As shown in Table 1, compared with the normal control group, the levels of creatine kinase isoenzyme (CK-MB) and lactate dehydrogenase (LDH) in the serum of the rats in the model group were significantly increased (P<0.01), indicating that the rats in the model group had myocardial damage; compared with the model group, the levels of creatine kinase isoenzyme (CK-MB) and lactate dehydrogenase (LDH) in the serum of the rats in the medium and high doses of Jingfang groups were significantly decreased (P<0.05, P<0.01), indicating that the myocardial damage in the rats with diabetic cardiomyopathy model was significantly improved after intervention with the medium and high doses of the Chinese medicine composition.

[0049] 3.2 Effects of Chinese herbal medicine composition on cardiac index in streptozotocin-induced diabetic cardiomyopathy model rats

[0050] Table 2 Effects of Chinese herbal medicine composition on cardiac index of rats with diabetic cardiomyopathy induced by streptozotocin ( n=10)

[0051]

[0052] Note: Compared with the normal control group *P<0.05, **P<0.01; compared with the model group # P<0.05, ## P<0.01.

[0053] As shown in Table 2, compared with the normal control group, the heart mass index and left ventricular mass index of the rats in the model group were significantly increased (P < 0.01), indicating that the rats in the model group showed significant myocardial hypertrophy and left ventricular remodeling; compared with the model group, the heart mass index and left ventricular mass index of the medium and high doses of Jingfang group were significantly decreased (P < 0.05, P < 0.01), indicating that the Chinese medicine composition of the present invention can improve the changes in the heart structure of the model rats.

Claims

1. Use of a Chinese medicine composition in preparing a drug for preventing or treating diabetic cardiomyopathy, characterized in that: The Chinese medicine composition is made of the following components in parts by weight: 5-30 parts of Schizonepeta tenuifolia, 5-30 parts of Saposhnikovia divaricata, 5-30 parts of Notopterygium wilfordii 5-30 parts of Angelica dahurica, 3-25 parts of Bupleurum chinense, 3-25 parts of Peucedanum chinense. 5-30 parts of Chuanxiong, 3-25 parts of Citrus aurantium, 5-30 parts of Poria 3-25 parts of Platycodon grandiflorum and 1-10 parts of Licorice.

2. The use according to claim 1, characterized in that The Chinese medicine composition is made of the following components in parts by weight: 15 parts of Schizonepeta tenuifolia, 15 parts of Saposhnikovia divaricata, 15 parts of Notopterygium wilfordii 15 parts of Angelica dahurica, 15 parts of Bupleurum chinense, 15 parts of Peucedanum chinense 15 parts of Chuanxiong, 15 parts of Citrus aurantium, 15 parts of Poria cocos 15 parts of Platycodon grandiflorum and 5 parts of Licorice.

3. The use according to any one of claims 1 to 2, characterized in that The preparation dosage form of the traditional Chinese medicine composition is tablets, capsules, pills, granules, mixtures or powders.

4. The use according to claim 3, characterized in that The dosage form of the preparation is a mixture.

5. The use according to claim 3, characterized in that The dosage form of the preparation is granules.

6. The use according to claim 1, characterized in that The diabetic cardiomyopathy is selected from type 1 diabetic cardiomyopathy or type 2 diabetic cardiomyopathy.

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