A traditional Chinese medicine compound composition for treating heart failure and Wenyang Ningxin Plaster

Abstract

A traditional Chinese medicine compound composition for treating heart failure and Wenyang Ningxin Plaster belong to the technical field of traditional Chinese medicine preparations. This prescription is composed of white mustard seeds, processed kansui root, semen lepidii, cassia twig, prepared aconite root, ground beetle, cortex moutan, and coix seed. The principle for selecting acupoints for external application of Wenyang Ningxin Plaster is mainly to warm and tonify the heart and kidney, activate blood circulation and promote diuresis. The five acupoints selected are Tanzhong, Xinshu, Juque, Shenshu, and Jingmen. Among them, Xinshu and Juque, Shenshu and Jingmen are the combinations of back-shu points and front-mu points of the heart and kidney, which can tonify the heart and kidney, promote diuresis and resolve dampness, and activate blood circulation and dredge meridians. Tanzhong is the front-mu point of the pericardium and the meeting point of the primordial qi of the whole body. It not only relies on its function of benefiting qi and dredging meridians for the heart, but also emphasizes its role in stimulating yang qi. The heart governs blood, and Tanzhong governs qi. Qi can generate blood, promote blood circulation, and blood can carry qi. The two complement each other. This prescription is characterized by treating both the symptoms and the root cause, and treating the heart and kidney simultaneously. It belongs to the characteristic external application therapy of traditional Chinese medicine, has the local characteristics of Xin'an medicine, is particularly beneficial in improving heart failure symptoms, etc., has definite curative effects, and has no toxic and side effects.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and specifically relates to a traditional Chinese medicine compound composition for treating heart failure and a Wenyang Ningxin Plaster. Background Art

[0002] Heart failure (HF) is a group of clinical syndromes caused by abnormal heart structure and / or function, resulting in impaired ventricular filling and / or ejection ability. The prevalence of heart failure in adults globally is 1% - 3%, and the standardized prevalence of heart failure in China is 1.1%. Heart failure mainly occurs in the elderly population, and more than 3 co-morbidities are often present. Chronic heart failure has a high degree of heterogeneity, with complex and diverse etiologies and pathophysiological changes. During the progression of the disease, multiple organ injuries such as the heart, liver, kidney, and gastrointestinal tract often occur. Many Western medicines cannot be used due to organ damage or low blood pressure.

[0003] Professor Cheng Xiaoyu is the tenth-generation heir of the Cheng's Internal Medicine in the northern part of She County, Xin'an, and a famous traditional Chinese medicine doctor in Anhui Province. According to the characteristics of Xin'an Medicine and long-term clinical observations, he formulated the Wenyang Ningxin Plaster for external application on acupoints, which can effectively improve the clinical symptoms of HF patients, reduce toxic and side reactions, and further improve the quality of life of patients. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine compound composition for treating heart failure and a Wenyang Ningxin Plaster, which are prepared according to the principle of monarch, minister, assistant, and guide in the formulation. The compound syndrome differentiates and treats by combining drugs for warming and tonifying the heart and kidney with drugs for promoting diuresis and resolving dampness, and activating blood circulation and dredging meridians. It not only takes into account the deficiency as the root cause of heart failure but also starts from the symptoms to activate blood circulation, dredge meridians, promote diuresis, and resolve dampness, treating both the symptoms and the root cause, and achieving good clinical effects.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0006] A traditional Chinese medicine compound composition for treating heart failure, which is prepared from the following traditional Chinese medicine raw materials by weight:

[0007] 1 - 3 parts of Semen Sinapis Albae, 1 - 3 parts of Radix Kansui Praeparata, 3 - 5 parts of Semen Lepidii, 3 - 5 parts of Ramulus Cinnamomi, 2 - 4 parts of Radix Aconiti Lateralis Praeparata, 4 - 6 parts of Eupolyphaga seu Steleophaga, 4 - 6 parts of Cortex Moutan, 2 - 4 parts of Rhizoma Smilacis Glabrae.

[0008] The formula explanations of each traditional Chinese medicine in this formula are as follows:

[0009] Semen Sinapis Albae

[0010]

Properties and Channels Entered

[0011]

Functions

[0012]

Indications

[0013]

Modern Pharmacology

[0014] Processed Kansui Root

[0015]

Properties and Channels Entered

[0016]

Functions

[0017]

Indications

[0018]

Modern Pharmacology

[0019] Descurainia Seed

[0020]

Properties and Channels Entered

[0021]

Functions

[0022]

Indications

[0023]

Modern Pharmacology

[0024] Cassia Twig

[0025]

Properties and Channels Entered

[0026]

Functions

[0027]

Indications

[0028]

Modern Pharmacology

[0029] Prepared Common Monkshood Daughter Root

[0030]

Properties and Channels Entered

[0031]

Functions

[0032]

Indications

[0033]

Modern Pharmacology

[0034] Ground Beetle

[0035]

Properties, Flavors and Meridians Entered

[0036]

Functions

[0037]

Applications

[0038]

Modern Pharmacology

[0039] Moutan Bark

[0040]

Properties, Flavors and Meridians Entered

[0041]

Functions

[0042]

Applications

[0043]

Modern Pharmacology

[0044] Glabrous Greenbrier Rhizome

[0045]

Properties, Flavors and Meridians Entered

[0046]

Functions

[0047]

Applications

[0048]

Modern Pharmacology

[0049] For the external application of this Warming Yang and Nourishing Heart Plaster, the acupoints of Tanzhong, Xinshu, Juque, Shenshu and Jingmen are selected, as follows:

[0050] Tanzhong

[0051]

Location

[0052]

Indications

[0053] Xinshu

[0054]

Location

[0055]

Indications

[0056] Jueque

[0057]

Location

[0058]

Indications

[0059] Shenshu

[0060]

Location

[0061]

Indications

[0062] Jingmen

[0063]

Location

[0064]

Indications

[0065] The principle of compatibility of traditional Chinese medicines in the present invention is as follows:

[0066] In the formula, Radix Aconiti Lateralis Preparata is a pungent and extremely hot herb, entering the heart and kidney meridians. Combined with Ramulus Cinnamomi which is warm in nature, the two together can warm and tonify the heart and kidney, serving as the monarch drug in the formula; Semen Sinapis Albae, Radix Kansui Praeparata and Semen Lepidii can resolve phlegm and promote diuresis, serving as the ministerial drugs in the formula; Eupolyphaga seu Steleophaga and Cortex Moutan can activate blood circulation and dredge collaterals, serving as the adjuvant drugs in the formula; Rhizoma Smilacis Glabrae can promote diuresis and relieve itching when used externally, serving as the guiding drug in the formula. Heart failure is based on deficiency, and it is treated from the heart and kidney. The whole formula combines drugs for warming and tonifying the heart and kidney with drugs for activating blood circulation and dredging meridians, promoting diuresis and resolving dampness for syndrome differentiation and treatment. It not only takes into account the deficiency as the root of heart failure, but also starts from the symptoms to activate blood circulation, dredge meridians, promote diuresis and resolve dampness, treating both the symptoms and the root cause, and can achieve good clinical effects.

[0067] Meanwhile, the present formula uses ginger juice, honey and mature vinegar as excipients. The principle of acupoint selection is mainly to warm and tonify the heart and kidney, activate blood circulation and promote diuresis. Five acupoints, i.e., Tanzhong, Xinshu, Jueque, Shenshu and Jingmen, are selected. Among them, Xinshu and Jueque, Shenshu and Jingmen are the combinations of back-shu points and front-mu points of the heart and kidney, tonifying the heart and kidney, promoting diuresis and resolving dampness, activating blood circulation and dredging meridians; Tanzhong is the front-mu point of the pericardium, where the primordial qi of the whole body converges. It not only relies on its function of benefiting qi and dredging meridians for the heart, but also emphasizes its role in stimulating yang qi. The heart governs blood, and Tanzhong governs qi. Qi can generate blood, promote blood circulation, and blood can carry qi. The two complement each other.

[0068] As a preferred technical solution of the present invention, the traditional Chinese medicine compound composition is prepared from the following traditional Chinese medicine raw materials by weight:

[0069] 2 parts of white mustard seed, 2 parts of processed kansui root, 4 parts of semen lepidii, 4 parts of cassia twig, 3 parts of aconite lateralis preparata, 5 parts of ground beetle, 5 parts of cortex moutan, 3 parts of glabrous greenbrier rhizome.

[0070] Grind each traditional Chinese medicine component in the formula amount into fine powder. After mixing, take an appropriate amount of the traditional Chinese medicine compound, mix it with an appropriate amount of mature vinegar, ginger juice, and honey, and make it into pills. Then, externally apply the pills on the positions of the chest center, heart shu point, great pastern point, kidney shu point, and jingmen point through a medicinal tape for treatment, that is, the warming yang and calming heart patch. Clinical verification shows that the present invention can be used to treat heart failure and has good therapeutic effects.

[0071] The traditional Chinese medicine compound composition proposed by the present invention is composed of Chinese herbal medicines such as white mustard seed, processed kansui root, semen lepidii, cassia twig, aconite lateralis preparata, ground beetle, cortex moutan, and glabrous greenbrier rhizome. This prescription features treating both the symptoms and root causes, and treating the heart and kidney simultaneously. It belongs to a characteristic external application therapy of traditional Chinese medicine and has the local characteristics of Xin'an medicine. It is particularly beneficial in improving heart failure symptoms (such as chest tightness, palpitation, shortness of breath, fear of cold, and edema), with definite curative effects and no toxic side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0072] Figure 1 Shows the changes in BNP of HF patients before and after treatment with the traditional Chinese medicine compound.

[0073] Figure 2 Shows the changes in 6MWT of HF patients before and after treatment with the traditional Chinese medicine compound.

[0074] Figure 3 Shows the changes in the TCM syndrome scores of HF patients before and after treatment with the traditional Chinese medicine compound. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0075] The following further details the present invention in conjunction with the embodiments and the drawings.

[0076] Example 1

[0077] Preparation of the warming yang and calming heart patch

[0078] Compound composition: 2 parts of white mustard seed, 2 parts of processed kansui root, 4 parts of semen lepidii, 4 parts of cassia twig, 3 parts of aconite lateralis preparata, 5 parts of ground beetle, 5 parts of cortex moutan, 3 parts of glabrous greenbrier rhizome.

[0079] Preparation method: Grind each traditional Chinese medicine component in the formula amount into 80-mesh fine powder. After mixing, take 1 part of the traditional Chinese medicine compound, mix it with 1 part of mature vinegar, 1 part of ginger juice, and 1 part of honey, and make it into pills. Divide the pills into 5 parts and externally apply them on the positions of the chest center, heart shu point, great pastern point, kidney shu point, and jingmen point through a medicinal tape (use Huoxue Zhitong Plaster if the skin is not allergic, and use anti-allergy adhesive tape if the skin is allergic) for treatment, that is, the warming yang and calming heart patch is made.

[0080] Example 2

[0081] A total of 10 patients diagnosed with heart failure in the First Affiliated Hospital of Anhui University of Chinese Medicine from 2023 to 2024 were included in this invention (the case information is shown in Table 3). They received the Wenyang Ningxin Plaster of this formula (prepared according to the method of Example 1) applied externally to acupoints (Danzhong, Xinshu, Juque, Shenshu, Jingmen), once a day, for 6 - 8 hours each time, applied 5 times a week, and 10 times was one course of treatment, for a total of 2 weeks. The efficacy was observed through the changes in BNP, 6MWT, and traditional Chinese medicine syndrome scores of the patients before and after treatment with this formula.

[0082] 1. Brain Natriuretic Peptide (BNP) assists in the diagnosis of heart failure, judges the severity of the condition and prognosis.

[0083] The BNP measurement results in this study were all provided by the Biochemical Immunology Laboratory of the First Affiliated Hospital of Anhui University of Chinese Medicine, and BNP was detected by chemiluminescence immunoassay (CLIA). The specific steps are as follows:

[0084] (1) Use an EDTA vacuum tube to draw 0.5 - 1 mL of blood from the patient (fasting is not required);

[0085] (2) Strictly measure according to the instructions of the B - type natriuretic peptide assay kit (chemiluminescent microparticle immunoassay method). The detection instrument is AHUCM / LAB - SOP - MY - YQ - 013, and the measurement is carried out according to the "Standard Operating Procedure for the Abbott ABBOTT ARCHITECT I2000SR Automatic Chemiluminescent Immunoassay Analyzer";

[0086] (3) Mix the sample with paramagnetic microparticles coated with BNP antibody. The BNP in the sample binds to the microparticles coated with BNP antibody, and the unbound part is washed away;

[0087] (4) Add an acridinium ester - labeled BNP antibody conjugate to form a reaction mixture, and wash away the unbound;

[0088] (5) Add the pre - excitation solution and the excitation solution. The acridinium ester emits light, and the instrument detects the luminescence intensity. The luminescence intensity is positively correlated with the amount of acridinium ester, that is, the amount of BNP. Then, by comparing with the standard curve obtained from a series of standard solutions with known concentrations stored in the instrument, the concentration of BNP in the test specimen can be calculated.

[0089] 2. The 6 - Minute Walk Test (6MWT) is to let the patient walk on a flat hard ground in a hiking manner to test the distance that can be walked at the fastest speed within 6 minutes. The specific operation steps are as follows:

[0090] (1) Explain the principle of the 6MWT to the patients, provide the same trial information to each patient, and the patients should read carefully and sign the informed consent form.

[0091] (2) The patients should wear comfortable clothes and suitable shoes, and should not wear slippers, high heels or go barefoot for the trial.

[0092] (3) The diet should be light before the trial, and do not overeat before the trial.

[0093] (4) The patients can carry the assistive tools (such as crutches, walkers, etc.) needed for their daily walking during the trial.

[0094] (5) Avoid strenuous activities within 2 hours before the patients' trial, do not need to do warm-up activities, and also do not do strenuous activities within 2 hours after the trial.

[0095] (6) The patients should sit on a chair near the starting point and rest for at least 15 minutes before the trial. At the same time, check for potential contraindications, explain the precautions of the trial to the patients, inform the methods of taking breaks in the middle and continuing to start, and can demonstrate the way to bypass the traffic cones.

[0096] (7) Adjust the timing counter (the counter is set to zero, and the timer is set to 6 minutes), and get the items in place.

[0097] (8) Guide the patients to stand on the starting line to start the trial. During the trial, the operator stands near the starting line and does not walk with the patients; use standard encouraging words with a uniform tone to encourage the patients during the trial. Report the time to the patients once a minute, remind the patients again when there are 15 seconds left, and tell the patients to stay in place when the timing ends. Do not use other encouraging words (or body languages). If the patients stop before 6 minutes and refuse to continue (or the operator judges that they should not continue), record the walking distance, the stopping time and the reasons for premature stopping (as shown in Table 1).

[0098] Table 1 6-Minute Walk Test Measurement Form

[0099]

[0100] 3. TCM Syndrome Scores

[0101] This study adopted the comparison of TCM syndrome scores to observe the improvement of this formula in TCM syndromes before and after treatment, providing certain ideas for the clinical treatment of heart failure with traditional Chinese medicine.

[0102] This study was statistically analyzed by doctors from the Geriatric Cardiology Department of the First Affiliated Hospital of Anhui University of Chinese Medicine. The specific steps are as follows:

[0103] Explain the significance of calculating the TCM syndrome scores to the patients, provide the same trial information to each patient, and after the patients express informed consent, the doctor carefully asks each patient about each item before and after heart failure treatment, conducts tongue coating and pulse condition examinations, and calculates the scores (as shown in Table 2).

[0104] Table 2 TCM Syndrome Scoring Table for Heart Failure

[0105]

[0106]

[0107] 4. Statistical Results

[0108] Table 3 Case Information and Statistical Results before and after Treatment

[0109]

[0110] Through Figure 1 、 2 3 and Table 3, it can be seen that compared with before treatment, the BNP of heart failure patients decreased after treatment (P<0.05), the 6MWT increased significantly (P<0.05), and the heart failure syndrome scores decreased (P<0.05). Therefore, the present invention provides an effective therapeutic drug for the clinical treatment of the refractory disease of heart failure, and has broad clinical application prospects.

[0111] The above content is only an example and explanation of the concept of the present invention. Those skilled in the art of the present technology can make various modifications or supplements to the described specific embodiments or use similar methods for substitution, as long as they do not deviate from the concept of the invention or exceed the scope defined by the claims of the present invention, they shall fall within the protection scope of the present invention.

Claims

1. A Chinese medicinal compound composition for external use in treating heart failure, characterized in that: Prepared from the following weights of Chinese medicinal raw materials: 1-3 parts of white mustard seeds, 1-3 parts of processed kansui, 3-5 parts of scutellaria seeds, 3-5 parts of cinnamon twigs, 2-4 parts of aconite root, 4-6 parts of earthworms, 4-6 parts of peony bark, and 2-4 parts of wild smilax glabra.

2. The Chinese medicine compound composition according to claim 1, characterized in that: Prepared from the following weights of Chinese medicinal raw materials: 2 parts of white mustard seeds, 2 parts of processed kansui, 4 parts of scutellaria seeds, 4 parts of cinnamon twigs, 3 parts of aconite root, 5 parts of earthworms, 5 parts of peony bark, and 3 parts of wild smilax.

3. A Wenyang Ningxin patch prepared from the Chinese medicine compound composition according to claim 1 or 2, characterized in that: Grind the various Chinese medicinal components in the formula into fine powder, mix them, take an appropriate amount of the Chinese medicinal compound, mix them with appropriate amounts of aged vinegar, ginger juice, and honey, make them into pills, and stick them on the Tanzhong, Xinshu, Juque, Shenshu, and Jingmen acupoints with medical tape to make the Wenyang Ningxin Patch.

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