Use of a traditional Chinese medicine compound composition in the preparation of a medicament for treating cardiovascular neurosis

Abstract

The application discloses application of a traditional Chinese medicine compound composition in preparation of a medicine for treating cardiovascular neurosis, and comprises the following traditional Chinese medicine decoction ingredients in parts of mass: 10-50 parts of lily, 10-60 parts of spina date seed, 6-20 parts of mulberry, 10-20 parts of rose, 15-30 parts of toona sinensis, 6-30 parts of bergamot, 10-20 parts of polygonatum, and 10-20 parts of jujube.The application mainly treats cardiovascular neurosis, has the effects of nourishing yin and moistening lung, regulating liver and calming heart, can obviously improve related symptoms of patients such as chest distress, palpitation and insomnia, the selected medicine is mild in nature, is a medicine and food homologous product, has small toxic and side effects in long-term taking, and is safe and reliable in medication.

Description

Technical Field

[0001] This invention pertains to traditional Chinese medicine compound compositions. Specifically, it relates to a traditional Chinese medicine compound composition and its preparation method that has therapeutic effects on cardiovascular neurosis and possesses the functions of nourishing yin and moistening the lungs, regulating the liver and calming the mind. Background Technology

[0002] Cardiovascular neurosis is a clinical syndrome characterized primarily by cardiovascular symptoms and is a type of functional neurosis. With societal progress and a faster pace of life, the number of patients with cardiovascular neurosis is increasing year by year. These patients primarily experience cardiovascular symptoms, including palpitations, shortness of breath, chest tightness, and even chest pain, often accompanied by dizziness, insomnia, and vivid dreams. The symptoms are varied and persistent, causing significant suffering and severely impacting patients' lives and work.

[0003] Modern medicine advocates psychotherapy as the primary treatment for cardiovascular neurosis, supplemented by drug therapy. However, in the current social environment, psychotherapy is difficult to achieve the expected results. Therefore, drug therapy is still the main treatment in clinical practice. Commonly used drugs for treating cardiovascular neurosis include beta-blockers, antidepressants such as duloxetine, and benzodiazepines. However, long-term use of duloxetine has many side effects, and the risk of relapse after discontinuation is high. Patients often cannot achieve satisfactory long-term results.

[0004] Based on clinical symptoms such as palpitations, chest tightness, chest pain, depression, and insomnia, cardiovascular neurosis is categorized under the traditional Chinese medicine (TCM) concept of "depression syndrome." Depending on the affected population and its causes, it can also be classified under the "lily disease" category. Currently, most scholars understand and treat cardiovascular neurosis from the perspective of the heart and liver, believing that liver qi stagnation and heart-spirit malnourishment are the core pathogenic mechanisms. Soothing the liver and relieving depression, nourishing the heart and calming the mind are common treatment methods. While these methods have achieved some success, a considerable number of patients still experience unsatisfactory results. We propose that the occurrence of cardiovascular neurosis is also closely related to the lungs, advocating treatment from the perspective of the "lungs," and proposing a treatment method of "nourishing yin and moistening the lungs, regulating the liver and calming the heart." Clinical experience has shown significant efficacy in this approach.

[0005] The fundamental pathogenesis of depression lies in the stagnation of Qi. As stated in *Zhengzhi Huibu* (Collection of Diagnostic and Treatment Methods) on depression: "Although there are many types of depression, they are all caused by the obstruction of Qi circulation. The treatment should prioritize regulating Qi." From the perspective of Qi circulation, depression is a Qi disorder, and the lungs govern the Qi of the whole body. The *Suwen* (Plain Questions) on the essential principles of Qi states: "All Qi stagnation belongs to the lungs." Therefore, Qi stagnation is closely related to lung dysfunction. By regulating the lungs, the Qi of the whole body can be regulated, thus promoting the smooth flow of Qi and treating depression.

[0006] Patients with cardiovascular neurosis exhibit altered mental states such as depression, sadness, and a tendency to cry. Sadness and sorrow are both associated with the lungs. The *Suwen* (Plain Questions) states, "In the organs, it is the lungs… in the emotions, it is sorrow," and the *Suwen* also points out, "When essence and qi converge in the lungs, sadness arises." Simultaneously, lung stagnation can lead to liver qi stagnation, resulting in emotional depression. The physiological connection between the lungs and liver is primarily manifested in the regulation of the body's qi (vital energy). Liver qi should ascend, while lung qi should descend; this coordinated ascending and descending of qi plays a crucial role in the smooth flow of qi and the harmony of blood throughout the body, a concept the ancients referred to as "the dragon and tiger in a cycle." Liver ascending and lung descending are interdependent and mutually supportive; therefore, regulating the lungs can soothe the liver, achieving a complementary therapeutic effect. The liver is the mother of the heart, and the heart is the monarch of the body, governing vital activities; the liver is the general of the body, responsible for regulating the flow of qi and emotions. At the same time, "the heart stores the spirit, and the liver stores the soul." Only when the liver's function of regulating the flow of qi is normal can the body feel relaxed and at ease, have a peaceful mind and a tranquil spirit, and achieve harmony among the five internal organs, thus preventing disease. As stated in "Miscellaneous Medical Treatises of the Ming Dynasty": "The liver is the mother of the heart. When the liver qi flows smoothly, the heart qi is harmonious."

[0007] The term "Lily Disease" was first mentioned in Zhang Zhongjing's "Essential Prescriptions of the Golden Chamber" during the Han Dynasty. The core pathogenesis of Lily Disease is the deficiency of Yin in the heart and lungs with internal heat. Lily and Rehmannia Decoction is the main prescription for treating Lily Disease. It can nourish Yin, clear heat, and tonify the heart and lungs. When Yin is restored, heat subsides, and all the meridians are harmonized, Lily Disease will be cured. This shows that the key to treating lung diseases is nourishing Yin.

[0008] In summary, we propose that the lungs are the key organ involved in cardiovascular neurosis, with the heart and liver also involved. The core pathogenesis is "lung yin deficiency, liver qi stagnation, and restlessness of the mind." We propose the treatment method of "nourishing yin and moistening the lungs, regulating the liver and calming the mind," which has shown significant clinical efficacy. Summary of the Invention

[0009] Purpose of the invention

[0010] The purpose of this invention is to provide a traditional Chinese medicine compound composition that has a therapeutic effect on cardiovascular neurosis and its preparation method.

[0011] Technical solution adopted

[0012] To achieve the above-mentioned objectives, the effective components and their mass fractions of the traditional Chinese medicine compound composition developed in this invention are as follows: 10-50 parts of lily bulb, 10-60 parts of jujube seed, 6-20 parts of mulberry, 10-20 parts of rose, 15-30 parts of mimosa flower, 6-30 parts of Buddha's hand, 10-20 parts of polygonatum, and 10-20 parts of jujube.

[0013] Preparation method of traditional Chinese medicine compound composition: Take lily bulb, jujube seed, mulberry, rose, mimosa flower, Buddha's hand, polygonatum and jujube according to the above-mentioned mass proportions, add water and decoct twice, each time for 0.5 hours, combine the decoctions, filter, concentrate the filtrate, and finally concentrate into 20ml of extract.

[0014] Based on the clinical manifestations of cardiovascular neurosis, it can be classified under the category of "depression syndrome," and according to its affected population and causes, it can also be classified under the category of "lily disease." We propose that the main pathogenesis of this disease is "deficiency of lung yin, stagnation of liver qi, and restlessness of the mind," with the main location of the disease in the lungs, closely related to the heart and liver. We propose the treatment method of "nourishing yin and moistening the lungs, regulating the liver and calming the mind."

[0015] The disease of lily was first recorded in the *Synopsis of Prescriptions of the Golden Chamber*, which states, "Lily disease is caused by the convergence of all meridians." Lily and Rehmannia Decoction is a classic formula for treating lily disease, primarily nourishing yin and moistening the lungs, clearing the heart and calming the mind. Based on this, lily is chosen as the principal ingredient to nourish yin and moisten the lungs, clear the heart and calm the mind, and is indicated for symptoms such as restlessness, palpitations, insomnia, excessive dreaming, and mental confusion. The *Shennong's Classic of Materia Medica* states that "its sweetness can replenish the middle jiao, and when heat is cleared, qi is generated, thus replenishing the middle jiao and benefiting qi." The *Compendium of Materia Medica* also states, "The function of lily lies in benefiting qi and simultaneously promoting qi circulation; it nourishes the body's vital energy and also eliminates pathogenic factors. Therefore, Li Shi called it a beautiful medicine for draining and harmonizing the middle jiao." Sour jujube seed is sweet and sour in taste, neutral in nature, and enters the liver and heart meridians. It nourishes the heart and liver, calms the mind and soothes the spirit, astringes sweat and generates fluids, and is indicated for symptoms such as restlessness, insomnia, palpitations, excessive dreaming, weakness, excessive sweating, and thirst due to fluid depletion. The *Shennong Bencao Jing* states, "Sour jujube, sour and neutral in nature, treats cold and heat in the heart and abdomen, accumulation of pathogenic factors, soreness and pain in the limbs, and dampness-related numbness. Long-term consumption calms the five internal organs, lightens the body, and prolongs life." Mulberry, sweet and sour in nature, is cold in nature and enters the heart, liver, and kidney meridians. It nourishes yin and blood, generates fluids and moistens dryness, and treats liver and kidney yin deficiency, dizziness, tinnitus, palpitations, insomnia, and thirst due to fluid depletion. The *Ben Cao Shu* states, "Mulberry benefits yin qi and thus yin blood; blood is transformed from water, therefore it benefits yin blood." When used with sour jujube seed, they serve as assistant herbs. Rose, sweet and slightly bitter in nature, is warm in nature and enters the liver and spleen meridians. It soothes the liver, relieves depression, harmonizes blood, and relieves pain. The *Compendium of Materia Medica* states, "It relieves qi stagnation and liver depression, promotes blood circulation, harmonizes the middle jiao and improves appetite." The *Food Materia Medica* states, "It primarily benefits the lungs and spleen, nourishes the liver and gallbladder, dispels evil qi, and is fragrant and sweet, refreshing the mind." Buddha's Hand (Citrus medica var. sarcodactylis) is pungent, bitter, and sour in taste, warm in nature, and enters the liver, spleen, and lung meridians. It relieves liver qi stagnation, harmonizes the stomach, and relieves pain. The *New Compendium of Materia Medica* states that Buddha's Hand "regulates the qi of the upper jiao and stops vomiting, promotes the digestion of the middle jiao and strengthens the spleen." The combination of rose and Buddha's Hand enhances the liver-soothing and qi-regulating effects, serving as an adjuvant. Polygonatum sibiricum (Polygonatum sibiricum) is sweet in taste, neutral in nature, and enters the spleen, lung, and kidney meridians. It replenishes qi and nourishes yin, strengthens the spleen, and moistens the lungs. Jujube is sweet and warm, nourishing heart blood and calming the mind. The combined effects of these herbs nourish yin and moisten the lungs, relieve liver depression, and calm the mind. Beneficial effects

[0016] This invention provides a rationally formulated, safe, and effective traditional Chinese medicine composition for treating cardiovascular neurosis. Guided by traditional Chinese medicine theory, it combines the efficacy of multiple herbs, with each herb playing its specific role (principal, assistant, adjuvant, and guiding) to maximize their therapeutic effects. It addresses both the symptoms and the root cause, significantly improving the clinical symptoms of patients with cardiovascular neurosis, demonstrating definite efficacy. Furthermore, this product does not contain toxic herbs, has a proven therapeutic effect, broad indications, and is safe to use, representing a significant technological advancement. Specific Implementation

[0017] The efficacy of this therapy is illustrated by the following examples.

[0018] Example 1:

[0019] Sixty patients with cardiovascular neurosis who visited the Department of Cardiovascular Medicine at the Affiliated Hospital of Integrated Traditional and Western Medicine of Nanjing University of Chinese Medicine between January 1, 2023 and June 1, 2023 and met the inclusion criteria were selected as the study subjects. They were randomly divided into a control group and an observation group, with 30 patients in each group. There were no statistically significant differences in age, gender, and underlying diseases between the two groups (P>0.05).

[0020] 1.1 Diagnostic criteria

[0021] Western medicine diagnostic criteria: Refer to the diagnostic criteria for cardiovascular neurosis in the 9th edition of Internal Medicine. (1) Cardiovascular symptoms such as palpitations, shortness of breath, chest tightness, and precordial pain. (2) Accompanied by symptoms of autonomic dysfunction such as insomnia, dreaminess, anxiety, loss of appetite, dizziness, tinnitus, and sweating. (3) No evidence of organic heart disease after a detailed physical and cardiovascular examination.

[0022] 1.2 Inclusion Criteria

[0023] (1) Meets the diagnostic criteria for cardiovascular neurosis; (2) is between 20 and 75 years old, regardless of gender; (3) voluntarily joins the clinical trial and signs the informed consent form.

[0024] 1.3 Exclusion Criteria

[0025] (1) Individuals with coronary heart disease, heart failure, valvular heart disease or other serious systemic diseases; (2) Individuals with severe liver and kidney dysfunction or thyroid dysfunction; (3) Individuals with mental illness or a family history of mental illness; (4) Individuals who have taken anti-anxiety, antidepressant or other antipsychotic drugs in the past month; (5) Pregnant or lactating women; (6) Individuals with poor compliance, who cannot take medication on time and have difficulty completing the trial; (7) Individuals who are allergic to a certain component of the test drug or have physical contraindications.

[0026] 1.4 Treatment Methods

[0027] (1) Control group: Flupentixol and melitracen (Hainan Huineng Pharmaceutical Co., Ltd., National Drug Approval Number: H20143390, Specification: Each tablet contains 0.5 mg flupentixol and 10 mg melitracen) were administered once in the morning and once at noon each day, one tablet each time, for 4 weeks.

[0028] (2) Treatment group: In addition to the control group, the concentrated decoction of this Chinese herbal compound was added, 20ml orally in the morning and evening, for 4 weeks.

[0029] 2. Observation Indicators and Evaluation Criteria

[0030] 2.1 Clinical efficacy observation indicators

[0031] (1) Changes in the Hamilton Anxiety Rating Scale (HAMA) scores of patients before and after treatment;

[0032] (2) Changes in the Hamilton Depression Rating Scale (HAMD) scores of patients before and after treatment.

[0033] 2.2 Safety Observation Indicators

[0034] (1) Blood pressure, heart rate, complete blood count, urinalysis, stool routine, liver function, kidney function, etc.;

[0035] (2) Adverse reactions that may occur during treatment, such as drug allergies.

[0036] 2.3 Efficacy Evaluation Criteria

[0037] HAMA and HAMD scale scoring efficacy assessment criteria: based on the reduction rate ([(pre-treatment score)]).

[0038] The calculation and determination are based on the following formula: (score after treatment) / (score before treatment × 100%).

[0039] ① Cured: Clinical symptoms and signs disappear or basically disappear, with a score reduction rate ≥75%;

[0040] ② Significant effect: Clinical symptoms and signs show obvious improvement, with a reduction rate of 50% ≤ score reduction < 75%;

[0041] ③ Effective: Clinical symptoms and signs improve, with a reduction rate of 25% ≤ score reduction < 50%;

[0042] ④ Ineffective: Clinical symptoms and signs show no significant improvement, or even worsen, with a deduction rate of <25%.

[0043] 2.4 Statistical Analysis Methods

[0044] SPSS 22.0 software was used for statistical analysis of the obtained data. For continuous data that met the requirements of normality and homogeneity of variance, t-tests were used, and for those that did not, non-parametric tests were used. For count data, χ2 test was used. For ordinal data, rank-sum test was used. P < 0.05 indicated that the difference was statistically significant.

[0045] 3. Research Results

[0046] (1) Comparison of HAMA scale scores and therapeutic effects, as shown in Table 1.

[0047] Table 1 Comparison of HAMA scores before and after treatment in the two groups of patients

[0048]

[0049] There was no statistically significant difference in HAMA scores between the two groups before treatment (P > 0.05). Within each group, comparisons of HAMA scores before and after treatment showed statistically significant differences (P < 0.05), indicating that both treatment regimens reduced HAMA scores. After treatment, a statistically significant difference was found between the treatment and control groups (P < 0.05), suggesting that the treatment group reduced HAMA scores more effectively than the control group.

[0050] As shown in Table 2, the efficacy of HAMA in the two groups of patients after treatment was compared. The difference was statistically significant (P < 0.05). The effective rate in the treatment group was higher than that in the control group, indicating that the treatment group had better HAMA efficacy than the control group.

[0051] Table 2 Comparison of HAMA efficacy before and after treatment in the two groups of patients

[0052]

[0053] (2) Comparison of HAMD scale scores and treatment efficacy

[0054] As shown in Table 3, there was no statistically significant difference in HAMD scores between the two groups before treatment (P > 0.05). Within each group, the HAMD scores before and after treatment were compared (P < 0.05), indicating a statistically significant difference, suggesting that both treatment regimens reduced patients' HAMD scores. After treatment, the HAMD scores of the treatment group were compared with those of the control group (P < 0.05), indicating a statistically significant difference, suggesting that the treatment group reduced patients' HAMD scores better than the control group.

[0055] Table 3 Comparison of HAMD scores before and after treatment in the two groups of patients

[0056]

[0057] As shown in Table 4, the efficacy of HAMD treatment in the two groups was compared, and the difference was statistically significant (P < 0.05). The effective rate in the treatment group was higher than that in the control group, indicating that the treatment group had better efficacy in treating HAMD than the control group.

[0058] Table 4 Comparison of HAMD efficacy before and after treatment in the two groups of patients

[0059]

[0060] Example 2:

[0061] The patient, a 50-year-old female, first visited on May 15, 2023. Chief complaint: Palpitations and chest tightness for over a year, worsening in the past week. For the past year, the patient has experienced recurrent palpitations and chest tightness without any obvious cause. These symptoms are paroxysmal, lasting from several minutes to several hours each time, occasionally accompanied by stabbing pain in the precordial region, insomnia, difficulty falling asleep, frequent awakenings at night, and low mood. She has visited the hospital multiple times, undergoing electrocardiograms, 24-hour Holter monitoring, echocardiography, coronary CTA, and thyroid function tests, all of which showed no significant abnormalities. No specific treatment was given, but the palpitations and chest tightness persist, severely impacting her daily life and causing her great distress. She previously consulted a psychiatrist, and after relevant examinations and evaluation by a professional doctor, moderate anxiety with moderate depression was considered, and anti-anxiety medication was recommended. However, the patient was unwilling to take the medication due to concerns about side effects. The patient experienced palpitations and chest tightness again over the past week due to emotional fluctuations, along with occasional sweating, difficulty falling asleep, and light, dream-filled sleep. They sought help from a traditional Chinese medicine practitioner and were prescribed a heart-nourishing and calming ointment, one packet twice a day, morning and evening, dissolved in warm water and taken one hour after meals. Two weeks later, at a follow-up visit, the patient reported significant improvement in palpitations and chest tightness, with a marked reduction in frequency and severity, and improved sleep. The patient continued treatment with the heart-nourishing and calming ointment for another month to consolidate the improvement. The palpitations and chest tightness symptoms essentially disappeared, and there has been no recurrence to date.

Claims

1. The application of a traditional Chinese medicine compound composition in the preparation of a drug for treating cardiovascular neurosis, characterized in that... The raw materials are lily 10-50 parts, Chinese date kernel 10-60 parts, mulberry 6-20 parts, rose flower 10-20 parts, Chinese toona flower 15-30 parts, bergamot 6-30 parts, rhizoma polygonati 10-20 parts, and jujube 10-20 parts.

2. The preparation method of the traditional Chinese medicine compound composition according to claim 1, characterized in that: The lily, Chinese date kernel, mulberry, rose flower, Chinese toona flower, bergamot, rhizoma polygonati, and jujube are added with water and decocted twice, 0.5 hour each time, the decoction is combined, filtered, and the filtrate is concentrated, and finally concentrated into extract 20 ml.

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