Composition for relieving depression and anxiety of maintenance hemodialysis treatment patient and application thereof

Abstract

The invention provides a composition for relieving depression and anxiety of a maintenance hemodialysis treatment patient and application of the composition, and belongs to the technical field of traditional Chinese medicine. The composition provided by the invention is prepared from the following components in parts by weight: 25 to 35 parts of radix astragali seu hedysari, 10 to 20 parts of rhizoma polygonati, 10 to 20 parts of radix puerariae, 5 to 15 parts of rhizoma chuanxiong, 10 to 20 parts of rhizoma dioscoreae colletii, 25 to 35 parts of radix salviae miltiorrhizae, 8 to 18 parts of radix angelicae sinensis, 5 to 15 parts of radix aconiti lateralis preparata, 8 to 18 parts of stiff silkworm, 25 to 35 parts of herba violae, 10 to 20 parts of poria cocos and 8 to 18 parts of rhizoma atractylodis macrocephalae. According to the traditional Chinese medicine composition disclosed by the invention, all the components are synergistically matched, Qingjin needle treatment is combined, and the aims of balancing the body, eliminating evil and regulating mental tranquility are fulfilled by regulating the balance of internal organs, so that the traditional Chinese medicine composition has obvious curative effects on reducing the syndrome points of clinical traditional Chinese medicine of patients, reducing anxiety points and improving the inflammatory factor level; the traditional Chinese medicine composition has obvious effects of relieving discomfort of a patient, relieving anxiety state and relieving inflammatory response in a body.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis and its application. Background Technology

[0002] End-stage renal failure (uremia stage) is a decompensated renal failure resulting from one or more diseases of the kidneys or other organs. Metabolic diseases, primarily diabetes and hypertension, are becoming major contributing factors to contemporary chronic kidney disease (CKD) and ultimately end-stage renal failure. Maintenance hemodialysis (MHD) is crucial for maintaining and prolonging the lives of end-stage CKD patients. Studies show that nearly 40.2% of MHD patients experience varying degrees of anxiety and depression, which negatively impacts their prognosis and outcome. Therefore, researching a drug that can intervene in patients' emotional state, promptly alleviate their depression and anxiety, and improve long-term prognosis and outcome is imperative. Summary of the Invention

[0003] In view of this, the purpose of this invention is to provide a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis and its application. This invention, through a rational formulation and combined use with acupuncture, achieves the effect of "relieving depression," thereby improving the anxiety and depression state of patients. It also explores the evaluation of the effects of traditional Chinese medicine combined with external therapies on patients' emotions with a rigorous scientific approach, providing a foundation for further in-depth research on the psychological rehabilitation of MHD patients.

[0004] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis, comprising the following components in parts by weight: Astragalus membranaceus 25-35 parts, Polygonatum sibiricum 10-20 parts, Pueraria lobata 10-20 parts, Ligusticum chuanxiong 5-15 parts, Dioscorea hypoglauca 10-20 parts, Salvia miltiorrhiza 25-35 parts, Angelica sinensis 8-18 parts, processed Aconitum carmichaelii 5-15 parts, Bombyx batryticatus 8-18 parts, Viola yedoensis 25-35 parts, Poria cocos 10-20 parts, and Atractylodes macrocephala 8-18 parts.

[0005] As a preferred option, the following components are included in parts by weight: Astragalus membranaceus 28-32 parts, Polygonatum sibiricum 12-18 parts, Pueraria lobata 12-18 parts, Ligusticum chuanxiong 8-12 parts, Dioscorea hypoglauca 12-18 parts, Salvia miltiorrhiza 28-32 parts, Angelica sinensis 10-15 parts, processed Aconitum carmichaelii 8-12 parts, Bombyx mori 10-15 parts, Viola yedoensis 28-32 parts, Poria cocos 12-18 parts, and Atractylodes macrocephala 10-15 parts.

[0006] As a preferred option, the following components by weight are included: 30 parts Astragalus membranaceus, 15 parts Polygonatum sibiricum, 15 parts Pueraria lobata, 10 parts Ligusticum chuanxiong, 15 parts Dioscorea hypoglauca, 30 parts Salvia miltiorrhiza, 12 parts Angelica sinensis, 9 parts processed Aconitum carmichaelii, 12 parts Bombyx mori, 30 parts Viola yedoensis, 15 parts Poria cocos, and 12 parts Atractylodes macrocephala.

[0007] The present invention provides a method for preparing the composition, wherein the preparation method is as follows: weighing processed aconite root, decocting for 30-60 minutes, adding other components, continuing to decoct 1-3 times, filtering, collecting and combining the decoctions to obtain the composition.

[0008] As a preferred method, the amount of water used when decocting prepared aconite is 2 to 4 times the total mass of all components.

[0009] Preferably, the decocting time is 20-40 minutes per cycle, and the decocting temperature is 90-100°C.

[0010] Preferably, the mesh size of the filter screen is 80-120 mesh.

[0011] The present invention also provides the use of the described composition or the composition obtained according to the described preparation method in the preparation of a therapeutic agent for depression and anxiety.

[0012] Compared with the prior art, the present invention has the following beneficial effects: The present invention provides a composition and its application for relieving depression and anxiety in patients undergoing maintenance hemodialysis. In this invention, processed aconite and astragalus are the principal ingredients, warming the kidneys and assisting yang, invigorating qi and unblocking the meridians; polygonatum and kudzu are the assistant ingredients, nourishing the kidneys and replenishing essence. They play a leading role and have therapeutic effect on the main pathogenesis of kidney yang deficiency. Prolonged illness leads to blood stasis, and prolonged deficiency inevitably results in blood stasis. Ligusticum chuanxiong and angelica sinensis are added to promote qi and blood circulation, while salvia miltiorrhiza invigorates blood and removes blood stasis, thus achieving the effect of unblocking the blood vessels of the kidneys. Bombyx batryticatus and dioscorea hypoglauca are added to disperse nodules, eliminate dampness, and clear the bowels and eliminate turbidity. This invention, through the synergistic effect of its components and combined with acupuncture treatment, aims to achieve bodily balance and "dispel pathogens and regulate the spirit" by harmonizing the balance of the internal organs, effectively improving the anxiety state of MHD patients. The experimental results of this invention suggest that the combination of the composition of this invention with acupuncture has significant effects on reducing the clinical TCM syndrome score, reducing the anxiety score, and improving the level of inflammatory factors in patients. It also has a significant effect on relieving patient discomfort, alleviating anxiety, and reducing the inflammatory response in the body, providing a TCM-Western medicine approach for the psychological rehabilitation of clinical MHD patients. Detailed Implementation

[0013] This invention provides a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis, comprising the following components in parts by weight: Astragalus membranaceus: 25-35 parts, preferably 28-32 parts, and even more preferably 30 parts; 10-20 parts of Polygonatum, preferably 12-18 parts, and more preferably 15 parts; 10-20 parts of kudzu root, preferably 12-18 parts, and more preferably 15 parts; 5-15 parts of Ligusticum chuanxiong, preferably 8-12 parts, and more preferably 10 parts; The amount of Dioscorea hypoglauca is 10-20 parts, preferably 12-18 parts, and more preferably 15 parts; the type of Dioscorea hypoglauca is either Dioscorea nitida or Dioscorea glutinosa, preferably Dioscorea glutinosa. 25-35 parts of Salvia miltiorrhiza, preferably 28-32 parts, and even more preferably 30 parts; 8-18 parts of Angelica sinensis, preferably 10-15 parts, and more preferably 12 parts; 5-15 parts of processed aconite, preferably 8-12 parts, and more preferably 9 parts; 8-18 parts of silkworm pupae, preferably 10-15 parts, and more preferably 12 parts; Viola yedoensis 25-35 parts, preferably 28-32 parts, more preferably 30 parts; Poria cocos 10-20 parts, preferably 12-18 parts, and even more preferably 15 parts; 8-18 parts of Atractylodes macrocephala, preferably 10-15 parts, and even more preferably 12 parts.

[0014] In this invention, Astragalus membranaceus is sweet and slightly warm in nature, and enters the lung and spleen meridians. It has the functions of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting pus drainage and detoxification, and promoting wound healing and tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, blood deficiency and chlorosis, hemiplegia, numbness and pain, carbuncles and boils that are difficult to ulcerate, and chronic ulcers that do not heal.

[0015] Polygonatum rhizome is sweet and neutral in nature, and enters the spleen, lung, and kidney meridians. It has the functions of tonifying qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. It is used for spleen and stomach qi deficiency, fatigue, stomach yin deficiency, dry mouth and poor appetite, lung deficiency and dry cough, consumptive cough with hemoptysis, deficiency of essence and blood, soreness and weakness of the lower back and knees, premature graying of hair, and internal heat and thirst.

[0016] Kudzu root is sweet, pungent, and cool in nature, and enters the spleen, stomach, and lung meridians. It has the functions of relieving muscle tension and reducing fever, promoting body fluid production and quenching thirst, promoting rash eruption, raising yang and stopping diarrhea, unblocking meridians and activating collaterals, and detoxifying alcohol. It is used for exogenous fever and headache, stiff neck and back pain, thirst, diabetes, incomplete measles eruption, dysentery, diarrhea, dizziness and headache, hemiplegia due to stroke, chest pain, and alcohol poisoning.

[0017] Chuanxiong (Ligusticum striatum) is pungent and warm in nature, and enters the liver, gallbladder, and pericardium meridians. It has the functions of promoting blood circulation, regulating qi, dispelling wind, and relieving pain. It is used for chest pain, stabbing pain in the chest and ribs, swelling and pain from falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal masses, headache, and rheumatic pain.

[0018] Dioscorea hypoglauca is bitter and neutral in nature, and enters the kidney and stomach meridians. It has the functions of promoting diuresis and removing turbidity, dispelling wind and relieving numbness. It is used for chyluria, leukorrhea, excessive vaginal discharge, rheumatic pain, joint stiffness, and lower back and knee pain.

[0019] Salvia miltiorrhiza is bitter and slightly cold in nature, and enters the heart and liver meridians. It has the functions of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling. It is used for chest pain, abdominal and hypochondriac pain, abdominal masses, arthralgia due to heat, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0020] Angelica sinensis is sweet, pungent, and warm in nature, and enters the liver, heart, and spleen meridians. It has the functions of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic pain, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness.

[0021] Prepared aconite root is pungent, sweet, and very hot in nature, and enters the heart, kidney, and spleen meridians. It has the functions of restoring yang and rescuing from collapse, tonifying fire and assisting yang, and expelling wind, cold, and dampness. It is used for collapse due to yang deficiency, cold limbs and weak pulse, impotence, uterine cold, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, edema due to yin-cold, external pathogenic factors due to yang deficiency, and cold-dampness arthralgia.

[0022] Silkworm pupae are salty, pungent, and neutral in nature, and enter the liver, lung, and stomach meridians. They have the functions of calming wind and stopping spasms, dispelling wind and relieving pain, and resolving phlegm and dissipating nodules. They are used for liver wind with phlegm, infantile convulsions, tetanus, stroke with facial paralysis, wind-heat headache, red eyes and sore throat, itchy rashes, and mumps.

[0023] Viola yedoensis is bitter, pungent, and cold in nature, and enters the heart and liver meridians. It has the functions of clearing heat and detoxifying, cooling the blood and reducing swelling. It is used for boils, carbuncles, erysipelas, and snake bites.

[0024] Poria cocos is sweet, bland, and neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It has the functions of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0025] Atractylodes macrocephala is bitter, sweet, and warm in nature, and enters the spleen and stomach meridians. It has the functions of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0026] The present invention provides a method for preparing the composition, wherein the preparation method is as follows: weighing processed aconite root, decocting for 30-60 minutes, adding other components, continuing to decoct 1-3 times, filtering, collecting and combining the decoctions to obtain the composition.

[0027] In this invention, there are no special limitations on the source of raw materials; conventional commercially available products are sufficient. The preferred decoction time for processed aconite is 35-50 minutes, more preferably 45 minutes; the amount of water used during decoction is 2-4 times the total mass of all components, preferably 2.5-3.5 times, more preferably 3 times; the continued decoction time is 20-40 minutes per cycle, preferably 25-35 minutes, more preferably 30 minutes; the continued decoction temperature is 90-100℃, preferably 92-98℃, more preferably 95℃; the mesh size of the filtration sieve is 80-120 mesh, preferably 90-110 mesh, more preferably 100 mesh.

[0028] The present invention also provides the use of the described composition or the composition obtained according to the described preparation method in the preparation of a therapeutic agent for depression and anxiety.

[0029] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0030] Example 1

[0031] Weigh out 30g of Astragalus membranaceus, 15g of Polygonatum sibiricum, 15g of Pueraria lobata, 10g of Ligusticum chuanxiong, 15g of Dioscorea hypoglauca, 30g of Salvia miltiorrhiza, 12g of Angelica sinensis, 9g of processed Aconitum carmichaelii, 12g of Bombyx batryticatus, 30g of Viola yedoensis, 15g of Poria cocos, and 12g of Atractylodes macrocephala. Place the processed Aconitum carmichaelii in 615g of water, bring to a boil over high heat, then simmer over low heat for 45 minutes. Add the other components and continue simmering for 30 minutes to obtain the first decoction. Use a 100-mesh sieve to separate the solids from the decoction. Add 410g of water to the separated solids, bring to a boil over high heat, then simmer over low heat for 20 minutes. Separate the solids from the decoction using the same method to obtain the second decoction. Combine the two decoctions to obtain a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis.

[0032] Example 2

[0033] Weigh out 25g of Astragalus membranaceus, 10g of Polygonatum sibiricum, 10g of Pueraria lobata, 5g of Ligusticum chuanxiong, 10g of Dioscorea hypoglauca, 25g of Salvia miltiorrhiza, 8g of Angelica sinensis, 5g of processed Aconitum carmichaelii, 8g of Bombyx batryticatus, 25g of Viola yedoensis, 10g of Poria cocos, and 8g of Atractylodes macrocephala. Place the processed Aconitum carmichaelii in 298g of water, bring to a boil over high heat, then simmer over low heat for 30 minutes. Add the other components and continue simmering for 25 minutes to obtain the first decoction. Use a 100-mesh sieve to separate the solids from the decoction. Add 298g of water to the separated solids again, bring to a boil over high heat, then simmer over low heat for 20 minutes. Separate the solids from the decoction using the same method to obtain the second decoction. Combine the two decoctions to obtain a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis.

[0034] Example 3

[0035] Weigh out 35g of Astragalus membranaceus, 20g of Polygonatum sibiricum, 20g of Pueraria lobata, 15g of Ligusticum chuanxiong, 20g of Dioscorea hypoglauca, 35g of Salvia miltiorrhiza, 18g of Angelica sinensis, 15g of processed Aconitum carmichaelii, 18g of Bombyx batryticatus, 35g of Viola yedoensis, 20g of Poria cocos, and 18g of Atractylodes macrocephala. Place the processed Aconitum carmichaelii in 1076g of water, bring to a boil over high heat, then simmer over low heat for 60 minutes. Add the other components and continue simmering for 40 minutes to obtain the first decoction. Use a 100-mesh sieve to separate the solids from the decoction. Add 538g of water to the separated solids, bring to a boil over high heat, then simmer over low heat for 30 minutes. Separate the solids from the decoction using the same method to obtain the second decoction. Combine the two decoctions to obtain a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis.

[0036] Example 4

[0037] A composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis was prepared using the same preparation method as in Example 1, except that Dioscorea hypoglauca was replaced with Dioscorea nitida.

[0038] Comparative Example 1

[0039] A composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis was prepared using the same preparation method as in Example 1, except that Astragalus membranaceus was replaced with processed Astragalus membranaceus.

[0040] Comparative Example 2

[0041] A composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis was prepared using the same preparation method as in Example 1, except that Angelica sinensis was replaced with wine-processed Angelica sinensis.

[0042] Comparative Example 3

[0043] Weigh out 15g of Astragalus membranaceus, 5g of Polygonatum sibiricum, 5g of Pueraria lobata, 2g of Ligusticum chuanxiong, 5g of Dioscorea hypoglauca, 15g of Salvia miltiorrhiza, 4g of Angelica sinensis, 2g of processed Aconitum carmichaelii, 4g of Bombyx batryticatus, 15g of Viola yedoensis, 5g of Poria cocos, and 4g of Atractylodes macrocephala. Place the processed Aconitum carmichaelii in 243g of water, bring to a boil over high heat, then simmer over low heat for 45 minutes. Add the other components and continue simmering for 30 minutes to obtain the first decoction. Use a 100-mesh sieve to separate the solids from the decoction. Add 162g of water to the separated solids, bring to a boil over high heat, then simmer over low heat for 20 minutes. Separate the solids from the decoction using the same method to obtain the second decoction. Combine the two decoctions to obtain a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis.

[0044] Comparative Example 4

[0045] Weigh out 45g of Astragalus membranaceus, 30g of Polygonatum sibiricum, 30g of Pueraria lobata, 25g of Ligusticum chuanxiong, 30g of Dioscorea hypoglauca, 45g of Salvia miltiorrhiza, 30g of Angelica sinensis, 25g of processed Aconitum carmichaelii, 30g of Bombyx batryticatus, 45g of Viola yedoensis, 30g of Poria cocos, and 30g of Atractylodes macrocephala. Place the processed Aconitum carmichaelii in 1185g of water, bring to a boil over high heat, then simmer over low heat for 45 minutes. Add the other components and continue simmering for 30 minutes to obtain the first decoction. Use a 100-mesh sieve to separate the solids from the decoction. Add 790g of water to the separated solids, bring to a boil over high heat, then simmer over low heat for 20 minutes. Separate the solids from the decoction using the same method to obtain the second decoction. Combine the two decoctions to obtain a composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis.

[0046] Comparative Example 5

[0047] A composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis was prepared using the same preparation method as in Example 1, except that processed aconite was replaced with cinnamon.

[0048] Experimental Example 1

[0049] The composition obtained in Example 1 for alleviating depression and anxiety in patients undergoing maintenance hemodialysis was administered to mice via gavage to observe its toxicity. Healthy SPF-grade mice (half male, half female, weighing 18-22g) were selected and, after 3 days of acclimatization, randomly divided into four groups of 10 mice each: a high-dose group, a medium-dose group, a low-dose group, and a blank control group. The high-dose group received 0.3 mL / 10g via gavage, the medium-dose group received 0.2 mL / 10g, the low-dose group received 0.1 mL / 10g, and the blank control group received no treatment. Mice were allowed free access to food and water and were fed continuously for 4 weeks. Daily observations were made of behavior, diet, responses to stimuli, secretions, and excretions. Toxicity reactions were recorded, including symptoms, onset time, severity, duration, and mortality. Histopathological examinations were performed on any abnormalities. The results are shown in Table 1.

[0050] Table 1. Records of mouse status in different groups

[0051] As shown in Table 1, no animal deaths occurred within 4 weeks of continuous administration. Mice in different feeding groups exhibited normal behavior, mental state, and bowel movements, and showed good growth and development. No other significant behavioral changes or signs of poisoning were observed, indicating that this product has no toxic side effects on animals.

[0052] Experiment Example 2

[0053] A mouse model of depression and anxiety was established using different chronic unpredictable stress (CUMS) methods. Healthy male BALB / c mice, weighing 20-22g, were acclimatized for 3 days and then randomly divided into 12 groups of 10 mice each: a normal control group, a model group (saline), experimental groups 1-9 (Examples 1-4 and Comparative Examples 1-5), and a positive control group (fluoxetine). CUMS stimulation continued during the administration of the drugs. The normal control group and the model group were administered saline by gavage at a dose of 0.2 mL / 10 g. Experimental groups 1-9 were prepared according to the methods described in Examples 1-4 and Comparative Examples 1-5, and administered the saline by gavage at a dose of 0.2 mL / 10 g. The positive control group was administered fluoxetine intraperitoneally at a dose of 0.1 mL / 10 g. Behavioral assessments were performed one week after administration.

[0054] Modeling method: Except for the normal group, the mice in the other groups were housed in individual cages and stimulated daily according to Table 2. The stimulation was carried out for 4 consecutive weeks with 7 days as one cycle, and different chronic unpredictable stress was used to construct mouse models of depression and anxiety.

[0055] Behavioral tests included fluid consumption test, forced swimming test, tail suspension test, open field test, and weighted swimming test. The fluid consumption test was conducted according to the method of Pang Congfei (Pang Congfei, et al. Establishment of a chronic stress rat depression model [J]. Journal of Youjiang Medical College for Nationalities, 2016, 38(04):355-358.).

[0056] Forced swimming experiment: Mice were forced to swim for 6 minutes in a transparent plastic cylinder filled with 15 cm of water (water temperature maintained at 22-23℃). The time spent motionless in the last 4 minutes was recorded. Motionlessness was defined as floating vertically in the water while only performing the necessary movements to keep the head above water. After the experiment, the mice were removed and heated under a heat lamp until their bodies were dry.

[0057] Tail suspension test: Gently lift the mouse and fix its tail about 1 cm from the bottom to the hook of the test box with tape. Keep the environment quiet and use the tail suspension test system to record the mouse's activity during the 6 minutes of hanging upside down. Use software to collect the mouse's cumulative immobility time during the last 4 minutes.

[0058] Open field test: Mice were placed in a 50cm×50cm×40cm white open box, the bottom of which was divided into 16 small squares. The total distance the mice traveled in the open field and the time spent in the central area of ​​the open field were recorded within 5 minutes to assess the mice's anxiety level.

[0059] Weighted swimming test: After applying 12% of the mouse's body weight to the tail 1-3 cm away from the mouse, the time from when the mouse was put into the water until it sank to the bottom for 8 seconds was recorded as the mouse's sinking latency.

[0060] Table 2 Stimulation methods during modeling

[0061] Table 3 Effects of different treatment groups on mice

[0062] Table 3 shows that, compared with the normal group, the model group mice exhibited significant depressive and anxious behaviors, and showed significant weight loss, decreased sugar water preference, significantly increased tail suspension time, significantly prolonged struggle time in the forced usefulness test, significantly shortened total movement distance, significantly increased central area dwell time, and significantly decreased weighted swimming time, demonstrating a state of despair. After administration of the compositions prepared in Examples 1-4 of this invention, the experimental groups 1-4 showed improvement compared with the model group, and there was no significant difference compared with the positive control group. This indicates that the compositions prepared in this invention have a good therapeutic effect on depressed and anxious mice. Analysis of the results of Comparative Examples 1-5 and Examples 1-4 shows that the types and proportions of raw materials in the composition directly affect the therapeutic effect, and only the compositions of this invention can achieve effective treatment of depressed and anxious mice.

[0063] Experimental Example 3

[0064] Experimental drug: The composition prepared in Example 1 of this invention is used, taken twice a day, one part each time (the amount of each drug component in Example 1 is decocted to obtain about 300 mL of composition liquid), taken half an hour to 1 hour after meals.

[0065] Experimental Participants: Ninety patients with chronic renal failure undergoing maintenance hemodialysis at the Minhang District Hospital of Integrated Traditional Chinese and Western Medicine in Shanghai (CKD stage 5, eGFR < 15 ml / min·1.73 m²) were recruited between January 2023 and December 2024. 2 (And be in a continuous hemodialysis state; age 18-80 years old, gender not limited; agree to participate in this study and be able to sign informed consent form) Participants were randomly divided into three groups: treatment group 1 took the oral composition only, treatment group 2 took the oral composition in combination with traditional Chinese medicine acupuncture, and the control group took the oral composition in combination with a placebo patch. The treatment course was 3 months. Acupuncture or patch was applied to the bilateral Zusanli, Sanyinjiao, Yongquan, and Shenshu acupoints. The patch was applied on each dialysis day for 20 minutes.

[0066] Detection indicators: CRP, IL-6, Hamilton Anxiety Rating Scale (HAMA) score, Self-Rating Anxiety Scale (SAS) score, Self-Rating Depression Scale (SDS) score, and TCM clinical efficacy score were detected before and after treatment. The results are shown in Tables 4-6.

[0067] Table 4. HAMA, SAS, and SDS scores (x±s) of the three groups of patients.

[0068] Table 5. IL-6 and CRP levels (x±s) before and after treatment in the three groups of patients.

[0069] Table 6 Comparison of TCM clinical syndrome scores among the three groups

[0070] As shown in Tables 4-6, there was no significant difference between treatment group 1 and the control group. Compared with treatment group 2, while the composition of this invention alone can improve the levels of inflammatory factors, anxiety, and depression in MHD patients, the effect is more significant when combined with acupuncture. Furthermore, treatment group 2 showed a significant effect compared to the control group in reducing CRP and IL-6 inflammatory factor levels, reducing depression and anxiety scores, and reducing TCM clinical syndrome scores. Therefore, it can be concluded that when the composition of this invention is used in combination with acupuncture, it has a significant effect on improving the levels of inflammatory factors, reducing anxiety and depression in MHD patients, improving clinical symptoms, reducing the occurrence of adverse prognostic events, and improving the quality of life of patients.

[0071] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A composition for relieving depression and anxiety in patients undergoing maintenance hemodialysis, characterized in that, It includes the following components by weight: Astragalus membranaceus 25-35 parts, Polygonatum sibiricum 10-20 parts, Pueraria lobata 10-20 parts, Ligusticum chuanxiong 5-15 parts, Dioscorea hypoglauca 10-20 parts, Salvia miltiorrhiza 25-35 parts, Angelica sinensis 8-18 parts, processed Aconitum carmichaelii 5-15 parts, Bombyx mori 8-18 parts, Viola yedoensis 25-35 parts, Poria cocos 10-20 parts, and Atractylodes macrocephala 8-18 parts.

2. The composition according to claim 1, characterized in that, It includes the following components by weight: Astragalus membranaceus 28-32 parts, Polygonatum sibiricum 12-18 parts, Pueraria lobata 12-18 parts, Ligusticum chuanxiong 8-12 parts, Dioscorea hypoglauca 12-18 parts, Salvia miltiorrhiza 28-32 parts, Angelica sinensis 10-15 parts, processed Aconitum carmichaelii 8-12 parts, Bombyx batryticatus 10-15 parts, Viola yedoensis 28-32 parts, Poria cocos 12-18 parts, and Atractylodes macrocephala 10-15 parts.

3. The composition according to claim 1, characterized in that, The formula includes the following components by weight: Astragalus membranaceus 30 parts, Polygonatum sibiricum 15 parts, Pueraria lobata 15 parts, Ligusticum chuanxiong 10 parts, Dioscorea hypoglauca 15 parts, Salvia miltiorrhiza 30 parts, Angelica sinensis 12 parts, processed Aconitum carmichaelii 9 parts, Bombyx batryticatus 12 parts, Viola yedoensis 30 parts, Poria cocos 15 parts, and Atractylodes macrocephala 12 parts.

4. A method for preparing the composition according to any one of claims 1 to 3, characterized in that, The preparation method is as follows: weigh the prepared aconite root, decoct for 30-60 minutes, add other components, continue to decoct 1-3 times, filter, collect and combine the decoction to obtain the composition.

5. The preparation method according to claim 4, characterized in that, The amount of water used when decocting prepared aconite root is 2 to 4 times the total mass of all components.

6. The preparation method according to claim 4, characterized in that, The decocting time is 20-40 minutes per cycle, and the decocting temperature is 90-100℃.

7. The preparation method according to claim 4, characterized in that, The sieve used for filtration has a mesh size of 80-120.

8. The use of the composition according to any one of claims 1 to 3 or the composition obtained by the preparation method according to any one of claims 4 to 9 in the preparation of a therapeutic agent for depression and anxiety.

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