Traditional Chinese medicine composition for treating hypertension and anxiety codisease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for treating hypertension and anxiety codiseases as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from uncaria rhynchophylla, selfheal, radix cyathulae, motherwort fruit, cortex albiziae, mangnolia officinalis, fructus gardeniae praeparatus, fried sophora flower and mother-of-pearl. According to the traditional Chinese medicine composition provided by the invention, the whole formula is comprehensive, the compatibility is rigorous, and products for regulating qi activity and calming heart and tranquilizing are added on the basis of clearing and lowering liver fire, so that the traditional Chinese medicine composition has the effects of calming liver, suppressing yang, resolving depression and tranquilizing. Therefore, the uncaria and selfheal formula is used for treating hypertension with anxiety disorder and liver-yang hyperactivity, both symptoms and root causes are taken into consideration, viscera are enabled, and the treatment effects of unification of form and spirit and simultaneous treatment of body and mind are achieved. Through prospective, non-inferior and random contrast research, the uncaria and selfheal formula has excellent clinical curative effect and safety in intervention of hypertension related to mental stress and belonging to liver-yang hyperactivity.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a traditional Chinese medicine composition for treating hypertension and anxiety comorbidities, its preparation method, and its application. Background Technology

[0002] Hypertension, a complex and progressive cardiovascular syndrome caused by the interaction of multiple etiologies, has become a global public health problem that must be addressed. Mental and psychological factors are a significant risk factor for hypertension. Prolonged mental stress can activate the hypothalamic-pituitary-adrenal axis and the sympathetic nervous system, affecting blood pressure regulation. This type of hypertension, triggered by life and work stress and closely related to anxiety, depression, and other mental and psychological problems, is called mental stress-induced hypertension (MSI-HBP). Mental and psychological factors interact with blood pressure; insomnia, anxiety, and depression increase the risk of hypertension, while hypertensive patients are more prone to developing mental and psychological problems. Early identification of mental stress-induced hypertension and timely dual regulation of blood pressure and mental stress are crucial for blood pressure control and reducing the risk of cardiovascular disease.

[0003] The underlying pathogenesis of stress-related hypertension is complex, with activation of the renin-angiotensin-aldosterone system and abnormal sympathetic nerve activity being among the most widely accepted mechanisms. Therefore, in clinical practice, patients often require the combined use of multiple antihypertensive and psychotropic medications to address hypertension through different mechanisms. However, adverse reactions from long-term medication use are difficult to avoid.

[0004] Traditional Chinese medicine (TCM) takes a holistic approach to the diagnosis and treatment of this disease, emphasizing syndrome differentiation and treatment based on individual conditions. Through multi-target intervention, its effects are mild and side effects are minimal, leading to its widespread clinical application. Compared to similar products on the market, TCM preparations offer advantages such as better therapeutic efficacy, relatively lower prices, and greater ease of use. They can meet the personalized treatment needs of patients, reduce the financial burden of medication for many, and effectively treat hypertension, thus possessing a broad market potential. However, currently, there are few TCM preparations on the market specifically targeting stress-related hypertension, and their efficacy is significantly insufficient. Furthermore, the research and development of new TCM drugs is relatively lagging. Therefore, broadening research perspectives and developing new TCM drugs to combat stress-related hypertension remains crucial. Summary of the Invention

[0005] To address the research and development gaps in existing technologies, this invention provides a traditional Chinese medicine composition for treating hypertension and anxiety comorbidities.

[0006] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition.

[0007] Another objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating and intervening in stress-related hypertension.

[0008] The technical solution adopted by the present invention to achieve the above objectives is as follows: This invention provides a traditional Chinese medicine composition for treating hypertension and anxiety comorbidities, prepared from the following raw materials: Uncaria rhynchophylla 10-15 parts (added later), Prunella vulgaris 12-18 parts, Achyranthes bidentata 8-12 parts, Leonurus japonicus 8-12 parts, Albizia julibrissin bark 10-15 parts, Magnolia officinalis 8-12 parts, Gardenia jasminoides (fried) 6-10 parts, Sophora japonica (fried) 8-12 parts, and pearl powder 20-30 parts (decocted first).

[0009] Preferably, the traditional Chinese medicine composition for treating hypertension and anxiety comorbidity is prepared from the following raw materials: Uncaria rhynchophylla 12g (added later), Prunella vulgaris 15g, Achyranthes bidentata 10g, Leonurus japonicus 10g, Albizia julibrissin bark 12g, Magnolia officinalis 10g, Gardenia jasminoides 9g, Sophora japonica 10g, and pearl powder 25g (decocted first).

[0010] This invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: (1) Weigh each medicinal material according to the prescription amount, soak the mother-of-pearl separately in water and decoct it first to obtain the mother-of-pearl decoction; (2) Add soaked Prunella vulgaris, Achyranthes bidentata, Leonurus japonicus, Albizia julibrissin bark, Magnolia officinalis, Gardenia jasminoides, and Sophora japonica flowers to the decoction of mother-of-pearl. Bring to a boil over high heat, then simmer over low heat. (3) Add Uncaria rhynchophylla in the later stage of decoction and continue to decoct; (4) Filter the juice, add water to the dregs and decoct again, combine the two decoctions, concentrate and sterilize.

[0011] Preferably, in step (1), mother-of-pearl is first soaked in 8-10 times the amount of water for 30-40 minutes and then simmered for 25-30 minutes.

[0012] Preferably, in step (2), the simmering time is 20-30 minutes.

[0013] Preferably, in step (3), Uncaria rhynchophylla is added 5 minutes before the food is removed from the pot.

[0014] Preferably, in step (4), water is added to the dregs to cover the medicinal materials by 2-3 cm, and the mixture is decocted again for 15-20 minutes.

[0015] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating hypertension and anxiety comorbidity.

[0016] The traditional Chinese medicine composition provided by the present invention can be prepared into any pharmaceutically acceptable dosage form, including oral dosage forms. For example, if preparing tablets or capsules, the concentrated liquid after decocting is further concentrated into a thick paste, vacuum dried and pulverized, and excipients such as starch and magnesium stearate are added, granulated and pressed into tablets or filled into capsules.

[0017] Through clinical observation, it is found that liver depression transforming into fire and hyperactivity of liver yang are the common pathogenesis of hypertension and anxiety disorder, and "syndrome of hyperactivity of liver yang" is the main syndrome among them. Both types of diseases are mostly caused by mental stimulation. In the early stage of the diseases, the pathogenesis usually starts with liver qi stagnation. The liver fails to dredge and disperse, and over time, internal fire of the liver flares up, and yang hyperactivity occurs above. Patients mostly show symptoms such as dizziness, tinnitus, restlessness, irritability, insomnia, headache, head distension, bitter taste in the mouth, poor sleep, red complexion, red tongue, and taut pulse.

[0018] In view of the etiology and pathogenesis of mental stress-related hypertension, the present invention uses Uncaria rhynchophylla, Prunella vulgaris, Cyathula officinalis Kuan, Leonurus japonicus Houtt., Albizia julibrissin Durazz., Magnolia officinalis Rehd. et Wils., Gardenia jasminoides Ellis, Sophora japonica L. var. japonica f. japonica and Margarita to form the Uncaria rhynchophylla and Prunella vulgaris formula, which can clear liver fire, regulate emotions, and suppress liver yang, in order to achieve the therapeutic effect of unifying form and spirit and treating body and mind simultaneously. In the Uncaria rhynchophylla and Prunella vulgaris formula, Uncaria rhynchophylla is used as the monarch drug, and Prunella vulgaris is used as the minister drug. Uncaria rhynchophylla and Prunella vulgaris clear and drain liver heat and suppress liver wind; Magnolia officinalis descends adverse qi and promotes qi movement, assisting the function of the liver; Gastrodia elata Blume suppresses liver yang; Leonurus japonicus Houtt. promotes blood circulation and dredges collaterals, clears the liver and improves eyesight; Cyathula officinalis Kuan guides blood downward; Albizia julibrissin Durazz. relieves depression and soothes the nerves; Gardenia jasminoides Ellis purges fire and relieves restlessness; Sophora japonica L. var. japonica f. japonica suppresses liver yang; Margarita suppresses liver yang and sedates the mind.

[0019] Leonurus japonicus Houtt., that is, the seeds of Leonurus japonicus Houtt., is sweet, pungent, and slightly cold in nature, and belongs to the pericardium and liver meridians. "Compendium of Materia Medica" states that it: "Regulates qi and promotes blood circulation, nourishes the liver and benefits the heart, calms the soul and stabilizes the mind, and promotes blood circulation very quickly". Cyathula officinalis Kuan is sweet, slightly bitter, and neutral in nature, and belongs to the liver and kidney meridians. It can guide blood downward and assist Leonurus japonicus Houtt. in promoting qi movement and blood circulation; to treat liver qi, first dredge its stagnation, so Albizia julibrissin Durazz. is selected. It is sweet, neutral in nature, and belongs to the heart, liver, and lung meridians, and can relieve depression and soothe the nerves; Magnolia officinalis is bitter, pungent, and warm in nature, and belongs to the spleen, stomach, and large intestine meridians. It is good at promoting qi movement and relieving depression, and descending adverse qi. The two drugs are used together to soothe liver qi and regulate emotions.

[0020] The beneficial effects of the present invention are as follows: (1) For the traditional Chinese medicine composition provided by the present invention, overall observing the whole formula, the compatibility is rigorous. Based on clearing and reducing liver fire, products for regulating qi movement and calming the mind are added, jointly achieving the effect of suppressing liver yang and relieving depression and soothing the nerves. Therefore, the Uncaria rhynchophylla and Prunella vulgaris formula treats the syndrome of hyperactivity of liver yang in hypertension with anxiety disorder, taking into account both the symptoms and the root causes, coordinating the zang-fu organs, and achieving the therapeutic effect of unifying form and spirit and treating body and mind simultaneously;

[0021] (2) Through prospective, non-inferiority, randomized controlled studies, the Uncaria rhynchophylla and Prunella vulgaris formula has excellent clinical efficacy and safety in intervening in mental stress-related hypertension belonging to the syndrome of hyperactivity of liver yang. Description of the Drawings

[0022] Figure 1This is a flowchart of the experimental process. Detailed Implementation

[0023] The technical solution of the present invention will be further explained and described below through specific embodiments.

[0024] Example 1 Ingredients: Uncaria rhynchophylla 12g (added later), Prunella vulgaris 15g, Achyranthes bidentata 10g, Leonurus japonicus 10g, Albizia julibrissin bark 12g, Magnolia officinalis 10g, Gardenia jasminoides 9g, Sophora japonica 10g, and pearl powder 25g (decocted first).

[0025] The preparation method is as follows: (1) Weigh each medicinal material according to the prescription amount. Soak mother-of-pearl separately in 8 times its weight of water for 30 minutes, then decoct for 30 minutes. (2) Take 8-12 parts of Prunella vulgaris, Achyranthes bidentata, Leonurus japonicus, Albizia julibrissin, Magnolia officinalis, Gardenia jasminoides, and Sophora japonica, add water to cover the herbs by 2-3 cm, soak for 20 minutes, then add to the pearl powder decoction that has been decocted for 30 minutes, bring to a boil over high heat, then simmer over low heat for 20 minutes. (3) Add Uncaria rhynchophylla 5 minutes before removing from heat and continue simmering for 5 minutes; (4) Filter the juice, add 8 times the weight of water to the dregs and decoct again (15 min), combine the two decoctions, concentrate to 200 mL / bag, seal and sterilize, and you will get the product.

[0026] Example 1 This study evaluated the clinical efficacy and safety of a formula containing Uncaria rhynchophylla and Prunella vulgaris in treating stress-related hypertension (MSI-HBP) with liver yang hyperactivity syndrome. After obtaining informed consent from enrolled patients, a random number table consisting of 1-128 numbers was generated using SPSS 19.0 software. The numbers represented the inclusion order of the patients. The first 64 numbers corresponded to the experimental group treatment, while the last 64 numbers corresponded to the control group treatment.

[0027] 1. Test time and procedure The treatment period is 14 days; the flowchart is as follows. Figure 1 As shown.

[0028] 2 Study population 2.1 Western Medicine Diagnostic Criteria 2.1.1 Western medicine diagnostic criteria for hypertension: Hypertension was diagnosed according to the Chinese Guidelines for the Prevention and Treatment of Hypertension (2018 Revised Edition), as shown in Table 1.

[0029] Table 1. Classification and Definition of Blood Pressure Levels

[0030] According to the "Guidelines for the Prevention and Treatment of Hypertension in China" (2018 revised edition), patients with hypertension are divided into four levels based on their cardiovascular risk: low risk, intermediate risk, high risk, and very high risk, as shown in Table 2 below.

[0031] Table 2 Stratification of Cardiovascular Risk Level in Hypertensive Patients

[0032] 2.1.2 Diagnostic criteria for anxiety disorders: Meets the diagnostic criteria for generalized anxiety disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (meeting criteria 1-6 is sufficient): 1. For most of the days of at least 6 months, exhibit excessive anxiety and worry (anxious anticipation) about a number of events or activities (e.g., work or school performance); 2. Individuals find it difficult to control this worry; 3. This anxiety and worry is associated with at least 3 of the following 6 symptoms (at least some of these symptoms have been present on most days over the past 6 months): ① Feeling restless, excited, or nervous; ② Easily fatigued; ③ Difficulty concentrating or a complete mental blank; ④ Irritable; ⑤ Muscle tension; ⑥ Sleep disorders (difficulty falling asleep or staying asleep, or insufficient or unsatisfactory sleep quality);

[0033] 4. This anxiety, worry, or physical symptoms cause clinically significant distress or lead to impairment in social, occupational, or other important functions;

[0034] 5. This disorder cannot be attributed to the physiological effects of a substance (e.g., abused drugs) or other physical illnesses (e.g., hyperthyroidism);

[0035] 6. This disorder cannot be better explained by other mental disorders. For example, anxiety or fear of having a panic attack in panic disorder, negative evaluation in social anxiety disorder (social phobia), contamination or other obsessive thoughts in obsessive-compulsive disorder, separation anxiety disorder with separation from an attachment figure, cues of the traumatic event in post-traumatic stress disorder, weight gain in anorexia nervosa, bodily discomfort in somatic symptom disorder, feeling of physical imperfection in body dysmorphic disorder, feeling of having a serious illness in illness anxiety disorder, or the content of delusional beliefs in schizophrenia or paranoid disorders.

[0036] 2.2 Traditional Chinese Medicine Diagnostic Criteria: 2.2.1 Diagnostic criteria for pure excess without deficiency of liver yang hyperactivity syndrome Referring to the "General Principles of Clinical Research on New Traditional Chinese Medicine Drugs," the diagnosis should be made by two associate chief physicians or above. In TCM syndrome differentiation, if any one of the following primary symptoms and any three of the following secondary symptoms are present, and the tongue and pulse criteria are met, the diagnosis can be identified as pure excess with no deficiency, liver yang hyperactivity syndrome.

[0037] Main symptoms: dizziness and headache; Secondary symptoms: flushed face, red eyes, dry mouth, bitter taste in mouth, irritability, tinnitus, dark urine, constipation, numbness in limbs; Tongue and pulse: Red tongue, yellow coating, wiry and rapid pulse.

[0038] 2.2.2 Diagnostic criteria for anxiety disorders: Referencing the diagnostic criteria for depression in the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine" (2019 edition): (1) Symptoms include depression, low spirits, chest tightness and rib distension, frequent sighing, or irritability and crying, loss of appetite, or insomnia and dreaminess. (2) History of illness caused by emotional distress such as sadness, worry, anger, or anxiety; (3) Organic diseases can be ruled out through various systemic examinations; (4) It should be differentiated from epilepsy and mania.

[0039] 2.3 Selection Criteria ① Meets the criteria of hypertension classification 1 and cardiovascular risk stratification of low to intermediate risk; ② It meets the TCM diagnostic criteria for a pure excess-no-deficiency liver yang hyperactivity syndrome; ③ Meets the criteria for mild to moderate anxiety disorder, i.e., 14 ≤ Hamilton Anxiety Rating Scale (HAMA) score ≤ 29; ④ Age 18 or older and less than 65 years old; ⑤ Agree and sign the informed consent form; ⑥ Be able to understand and comply with research requirements.

[0040] 2.4 Exclusion Criteria Any of the following will be excluded: ① Those who do not meet the above diagnostic criteria and those who are included in the criteria; ② Patients with various types of secondary hypertension; ③ Patients with grade 2 and 3 hypertension; ④ Individuals assessed as high-risk or very high-risk in cardiovascular risk assessment; ⑤ Those who have already participated in other clinical trials or are currently receiving other treatments; ⑥ Individuals with serious diseases affecting various systems; ⑦ Individuals with conscious, intellectual, or mental abnormalities, as well as those suffering from depression, severe insomnia, anxiety, or high work stress; ⑧Pregnant and lactating women; ⑨ Individuals with communication difficulties, poor compliance, and uncooperative attitudes;

[0041] ⑩ Exclude other mental illnesses, including but not limited to: (1) Organic mental disorders; (2) Mental disorders caused by psychoactive substances or non-addictive substances; (3) Severe physical or neurological diseases, recent trauma, or infection or fever within the past week.

[0042] 2.5 Exit Criteria ① Situations where adverse reactions in the subjects are severe and, after assessment, the doctor deems it necessary to discontinue the treatment; ② If, during the trial, a subject develops a symptom that affects the trial results or their condition worsens, the doctor will make the decision to terminate the trial. ③ The experimental protocol deviated significantly during implementation, making it impossible to accurately evaluate the drug effect.

[0043] 3. Study Treatment Groups 3.1 Randomization Grouping After the enrolled cases signed informed consent forms, a random number table consisting of 1-128 numbers was generated using SPSS 19.0 software. The numbers were set as the inclusion order of the enrolled cases. The cases corresponding to the first 64 numbers in the random number table were treated with the experimental group regimen, and the cases corresponding to the last 64 numbers were treated with the control group regimen.

[0044] Experimental group: The group received conventional Western medicine treatment plus a formula of Uncaria rhynchophylla and Prunella vulgaris for 14 consecutive days.

[0045] a. Conventional Western medicine treatment: Lifestyle intervention combined with antihypertensive medication. Before the trial, all participants and their families were informed of pre-trial requirements, including hypertension health education, medication administration methods, and precautions and timing for testing, to enhance patient and family compliance. Lifestyle management followed the requirements of the "Chinese Guidelines for the Prevention and Treatment of Hypertension 2018." This included: a reasonable diet, smoking cessation and alcohol limitation, psychological adjustment, weight control, and regular exercise (such as two one-hour brisk walks or Tai Chi sessions per week). The antihypertensive medication used was valsartan capsules (manufactured by Tianda Pharmaceutical (Zhuhai) Co., Ltd., National Drug Approval Number H20030777, 80mg / capsule), administered at 80mg per morning.

[0046] b. Treatment with Uncaria rhynchophylla and Prunella vulgaris formula: This is a traditional Chinese medicine preparation, using a decoction form. It is based on the Uncaria rhynchophylla and Prunella vulgaris formula with modifications. The Chinese medicinal materials are provided by the pharmacy of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The dosage and usage of the medicinal materials comply with the relevant provisions of the 2020 edition of the Pharmacopoeia of the People's Republic of China.

[0047] Usage: One dose per day, decocted in water (specifically according to the preparation method provided in Example 1), prepared by the hospital's pharmacy according to standard procedures, 200ml / bag, individually sealed, taken warm twice a day, at 9:00 AM and 4:00 PM respectively, for a course of 14 days.

[0048] Ingredients: Uncaria rhynchophylla 12g (added later), Prunella vulgaris 15g, Achyranthes bidentata 10g, Leonurus japonicus 10g, Albizia julibrissin bark 12g, Magnolia officinalis 10g, Gardenia jasminoides 9g, Sophora japonica 10g, and pearl powder 25g (decocted first).

[0049] Control group: a. Received conventional Western medicine treatment (the content of which was the same as the experimental group, namely, lifestyle intervention treatment plus valsartan capsules for antihypertensive treatment), for a period of 14 days.

[0050] b. Administer 10 mg of oryzanol orally three times a day for 14 days. (Refer to the recommended medication in the "Expert Consensus on the Diagnosis and Treatment of Stress-Related Hypertension in Adults").

[0051] 4. Evaluation 4.1 Efficacy Assessment (1) Symptom-based efficacy evaluation criteria Referring to the TCM symptom grading and quantification standards for hypertension in the "TCM Diagnosis and Treatment Protocol for Vertigo (Primary Hypertension)," the primary symptoms of vertigo and headache were assigned scores of 2, 4, and 6 points respectively for mild, moderate, and severe manifestations. Secondary symptoms such as irritability, flushed face, red eyes, dry mouth, bitter taste in the mouth, tinnitus, numbness in the limbs, constipation, dark urine, red tongue, yellow coating, and wiry and rapid pulse were assigned scores of 1, 2, and 3 points respectively for mild, moderate, and severe manifestations. The total syndrome score was obtained by adding the quantified scores of each symptom of liver yang hyperactivity.

[0052] Referring to the 2002 edition of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)": The reduction in syndrome score = [(Pre-treatment score - Post-treatment score) ÷ Pre-treatment score] × 100%. See Table 3 for details.

[0053] Table 3

[0054] Based on the patient's actual condition, the TCM syndrome scores of the patient were statistically analyzed before and after treatment.

[0055] (2) Blood pressure treatment efficacy evaluation criteria The criteria for evaluating the antihypertensive efficacy are based on the "Guiding Principles for Clinical Trials of New Traditional Chinese Medicine Drugs for the Treatment of Hypertension"; as shown in Table 4.

[0056] Table 4

[0057] The patient's blood pressure was measured twice each morning before and after treatment, and during treatment (days 0, 7, and 14), with a 15-minute interval between the two measurements. The average value was then taken as the blood pressure value.

[0058] (3) Hamilton Anxiety Rating Scale, work stress assessment, sleep assessment, and quality of life assessment were performed in accordance with the "Expert Consensus on the Diagnosis and Treatment of Stress-Related Hypertension in Adults": ① The Hamilton Anxiety Scale (HAMA) is used to assess the severity of anxiety. It consists of 14 items and uses a 5-point rating scale, including physical and psychological anxiety symptoms. Higher scores indicate more severe anxiety symptoms. A HAMA score >29 is considered severe anxiety, 22–29 is moderate anxiety, and 14–21 is mild anxiety. The scale has a reliability coefficient of 0.93. ② The Mental Burnout Inventory-British (MGI-BS) assesses job burnout across three dimensions: emotional fatigue, job apathy, and lack of job satisfaction. Higher scores indicate higher levels of job burnout. ③ Pittsburgh Sleep Quality Index (PSQI): The PSQI is used to assess patients' sleep quality before and after treatment. It includes 7 items: time to fall asleep, sleep quality / time / efficiency / disorders, hypnotics, and daytime dysfunction. The total score is 21 points. The higher the score, the worse the sleep quality. ④ The SF-36 Health Status Questionnaire was used to assess the patient's quality of life before and after treatment, including physical functioning (PF), role-physical functioning (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional functioning (RE), and mental health (MH). Scores range from 0 to 100, with higher scores indicating better quality of life.

[0059] (4) Urine metabolomics analysis Urine samples were collected from the subjects. The urine samples were centrifuged at 2000 r / min for 10 min at 4℃, and the supernatant was aliquoted and stored at -80℃.

[0060] (5) Serum metabolomics analysis 6 ml of fasting venous blood was drawn from the subjects in the morning. The blood sample was retained in an EDTA anticoagulant tube and centrifuged at 3500 r / min for 10 min. The supernatant was then collected and stored at -80℃ for later use.

[0061] 4.2 Security Assessment 4.2.1 Baseline signs Before and after the trial, subjects' body temperature, pulse, respiration, heart rate, blood pressure, and anxiety level were monitored to assess the safety of the treatment plan.

[0062] 4.2.2 Laboratory Safety Assessment 1. Vital signs: T, P, R, BP (checked once at each follow-up visit, for a total of 5 times); 2. Complete blood count and urinalysis (two tests, one before and one after treatment). 3. Liver function and kidney function (tested once before treatment and once after treatment, for a total of 2 times); 4. Electrocardiogram (ECG) (once before treatment and once after treatment, for a total of 2 times); 5. Severity and incidence of adverse events. Record them in detail at all times.

[0063] 4.2.3 Physical Examination Cardiopulmonary examinations were performed on subjects before and after the trial to assess the safety of the treatment regimen.

[0064] 5. Data Processing SPSS 19.0 software was used for analysis. Quantitative data are expressed as mean ± standard deviation (±S). For data conforming to a normal distribution, paired t-tests were used for within-group comparisons, and independent samples t-tests were used for between-group comparisons. For data not conforming to a normal distribution, the rank-sum test was used. Chi-square tests were used for comparisons of categorical data. 2 For ordinal data, the rank-sum test is used. The significance level is set at α = 0.05, and P < 0.05 is considered statistically significant.

[0065] 6. Statistical Analysis 6.1 Determining the Sample Size A non-inferiority hypothesis testing design was adopted. Sample size estimation for two independent sample rates was performed as follows: α = 0.05, β = 0.2. To determine whether the treatment effect of the experimental group was non-inferior to the control group, the effective rate after treatment in the experimental group was set at pA = 85%, and the effective rate after treatment in the control group was set at pB = 77%. Based on literature review and previous research, the sample size calculation formula for the non-inferiority test was used.

[0066] The required sample size for each group was calculated. The research quality was strictly controlled during the experiment, and the loss to follow-up rate was kept at 10%. After expanding the sample size, in order to further improve the experiment, the total number of cases required for the two groups was finally determined to be 128, with 64 cases in the experimental group and 64 cases in the control group. This was to account for the worst-case scenario of high attrition during the study, because significant loss to follow-up would affect the success of the study. Appropriately increasing the sample size would make the experiment more convincing.

[0067] 6.2 Efficacy Analysis and Statistical Methods SPSS 19.0 software was used for analysis. Blood pressure levels and scores on each scale were compared between the two groups before and after treatment, expressed as mean ± standard deviation (±S). For data conforming to a normal distribution, paired t-tests were used for within-group comparisons, and independent samples t-tests were used for between-group comparisons. For data not conforming to a normal distribution, the rank-sum test was used. The efficacy rates of blood pressure reduction and improvement in TCM syndromes, sleep, work stress, and anxiety were compared between the two groups before and after treatment, using the chi-square test. 2 The significance level was set at α = 0.05, and P < 0.05 was considered statistically significant.

[0068] 6.3 Security Analysis and Statistical Methods The incidence of adverse events in the two groups of subjects was statistically analyzed using the χ² method. 2 Tests were performed to compare blood and urine routine tests and liver and kidney function before and after treatment in the two groups of subjects. For data conforming to a normal distribution, paired t-tests were used for within-group comparisons, and independent samples t-tests were used for between-group comparisons. For data not conforming to a normal distribution, rank-sum tests were used. The significance level was set at α = 0.05, and P < 0.05 was considered statistically significant.

[0069] 7. Results and Analysis 7.1 Comparison with baseline data Statistical methods were used to compare the baseline data of the two groups of patients: age is a continuous data point and both groups followed a normal distribution, so the independent samples t-test was used; BMI is a continuous data point but the two groups did not follow a normal distribution, so the Mann-Whitney U rank-sum test was used. The remaining data were count data and therefore non-continuous, so the chi-square test was used. The comparison of baseline data showed that there were no significant differences between the experimental group and the control group in terms of age, gender, BMI, smoking history, alcohol consumption history, comorbidities such as diabetes and coronary heart disease, and disease duration (P > 0.05). This indicates that the baseline data of the two groups were well-balanced and there were no significant differences (see Table 5).

[0070] This study collected data from 128 patients with essential hypertension and anxiety disorder, with 64 in the experimental group and 64 in the control group. A total of 118 subjects completed the entire study process and analysis, including 60 in the experimental group and 58 in the control group. During the study, 10 subjects dropped out: 4 in the experimental group (2 due to poor compliance; 2 due to protocol violation) and 6 in the control group (1 withdrew informed consent voluntarily; 1 failed to complete the prescribed treatment course; 4 due to protocol violation). All dropped out cases were not included in the validity analysis.

[0071] Table 5 Comparison of general information between the two groups of patients

[0072] 7.1.1 Comparison of syndrome scores and therapeutic effects (I) Comparison of TCM syndrome scores The Shapiro-Wilk test showed that the TCM syndrome scores of both groups before and after intervention were basically normally distributed. Independent samples t-tests showed no statistically significant difference in TCM syndrome scores between the two groups before treatment (P > 0.05). After 2 weeks of intervention, the TCM syndrome scores of the experimental group were significantly lower than those of the control group (P < 0.05). Paired t-tests showed that within-group comparisons indicated a significant decrease in TCM syndrome scores in both groups after intervention (P < 0.01).

[0073] Table 6 Comparison of TCM syndrome scores between the two groups

[0074] (II) Comparison of therapeutic effects based on TCM syndrome scoring After two weeks of intervention and treatment, the total effective rate of TCM syndrome scores in the experimental group was 80%, while that in the control group was 56.9%. Compared with the control group, the experimental group showed more significant efficacy, with a statistically significant difference (P<0.05), as shown in Table 7.

[0075] Table 7 Comparison of therapeutic effects between the two groups of TCM syndrome scores

[0076] (III) Comparison of blood pressure before and after treatment 1. Comparison of systolic blood pressure before and after treatment The Shapiro-Wilk test showed that the systolic blood pressure values ​​in both groups before and after treatment conformed to a normal distribution. An independent samples t-test was used for inter-group comparisons, and no statistically significant difference in systolic blood pressure was found between the two groups before treatment (P > 0.05). Compared with the control group, the experimental group showed a significant decrease in systolic blood pressure after treatment (P < 0.05). Paired t-tests were used for intra-group comparisons, and both groups showed a significant decrease in systolic blood pressure after treatment (P < 0.01), as shown in Table 8.

[0077] Table 8 Comparison of systolic blood pressure between the two groups

[0078] 2. Comparison of diastolic blood pressure before and after treatment The Shapiro-Wilk test showed that the diastolic blood pressure values ​​in both groups before and after treatment conformed to a normal distribution. An independent samples t-test was used for inter-group comparisons, and no statistically significant difference in diastolic blood pressure was found between the two groups before treatment (P > 0.05). Compared with the control group, the experimental group showed a significant decrease in diastolic blood pressure after treatment (P < 0.05). Paired t-tests were used for intra-group comparisons, and both groups showed a significant decrease in diastolic blood pressure after treatment (P < 0.01), as shown in Table 9.

[0079] Table 9 Comparison of diastolic blood pressure between the two groups

[0080] 3. Comparison of SAS scores before and after treatment Both groups followed a normal distribution according to the Shapiro-Wilk test before and after treatment. An independent samples t-test showed no statistically significant difference in SAS scores between the two groups before treatment (P > 0.05). After treatment, compared with the control group, the experimental group showed a significant and statistically significant decrease in SAS score (P < 0.05), as shown in Table 10.

[0081] Table 10 Comparison of SAS scores between the two groups

[0082] 4. Comparison of PSQI scores before and after treatment The Shapiro-Wilk test showed that the difference in PQSI scores before and after treatment was skewed, while the PQSI scores before and after treatment were normally distributed. Independent samples t-tests were used for inter-group comparisons, and no statistically significant difference was found in PQSI scores before treatment between the two groups (P > 0.05). Compared with the control group, the experimental group showed a significant decrease in PQSI scores after treatment (P < 0.05). Wilcoxon rank-sum tests were used for intra-group comparisons, and both groups showed a significant decrease in PQSI scores after treatment (P < 0.01), as shown in Table 11.

[0083] Table 11 Comparison of PQSI scores between the two groups

[0084] 5. Comparison of SF-36 levels before and after treatment Before treatment, there were no statistically significant differences in any of the parameters between the two groups (P > 0.05). Both groups showed significant improvements in PF, RP, VT, SF, GH, and MH after treatment, with statistical significance (P < 0.05). Compared with the control group, the RE level in the control group improved after treatment, but the improvement was not statistically significant (P > 0.05). After treatment, both groups showed significant improvements in PF and SF, with statistical significance (P < 0.05). After treatment, both groups showed improvements in RP, BP, VT, RE, GH, and MH, but the improvements were not statistically significant (P > 0.05).

[0085] Table 12 Comparison of SF-36 ratings between the two groups

Claims

1. A traditional Chinese medicine composition for treating hypertension and anxiety comorbidities, characterized in that, It is prepared from the following raw materials: Uncaria rhynchophylla 10-15 parts, Prunella vulgaris 12-18 parts, Achyranthes bidentata 8-12 parts, Leonurus japonicus 8-12 parts, Albizia julibrissin bark 10-15 parts, Magnolia officinalis 8-12 parts, Gardenia jasminoides (fried) 6-10 parts, Sophora japonica (fried) 8-12 parts, and pearl powder 20-30 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is prepared from the following raw materials: Uncaria rhynchophylla 12g, Prunella vulgaris 15g, Achyranthes bidentata 10g, Leonurus japonicus 10g, Albizia julibrissin bark 12g, Magnolia officinalis 10g, Gardenia jasminoides 9g, Sophora japonica 10g, and pearl powder 25g.

3. A method for preparing the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, Includes the following steps: (1) Weigh each medicinal material according to the prescription amount, soak the mother-of-pearl separately in water and decoct it first to obtain the mother-of-pearl decoction; (2) Add soaked Prunella vulgaris, Achyranthes bidentata, Leonurus japonicus, Albizia julibrissin bark, Magnolia officinalis, Gardenia jasminoides, and Sophora japonica flowers to the decoction of mother-of-pearl. Bring to a boil over high heat, then simmer over low heat. (3) Add Uncaria rhynchophylla in the later stage of decoction and continue to decoct; (4) Filter the juice, add water to the dregs and decoct again, combine the two decoctions, concentrate and sterilize.

4. The preparation method according to claim 3, characterized in that, In step (1), mother-of-pearl is first soaked in 8-10 times the amount of water for 30-40 minutes and then simmered for 25-30 minutes.

5. The preparation method according to claim 3, characterized in that, In step (2), the simmering time is 20-30 minutes.

6. The preparation method according to claim 3, characterized in that, In step (3), Uncaria rhynchophylla is added 5 minutes before the food is removed from the heat.

7. The preparation method according to claim 3, characterized in that, In step (4), add water to the dregs to cover the herbs by 2-3 cm, and decoct again for 15-20 minutes.

8. The use of a traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of a medicament for treating hypertension and anxiety comorbidities.

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