WO2024011723A1 - Use of traditional chinese medicine composition in preparation of drug for adjuvant treatment of depression - Google Patents

Abstract

The use of a traditional Chinese medicine composition in the preparation of a drug for adjuvant treatment of depression. The traditional Chinese medicine composition comprises Astragali radix, Fructus tritici levis, Jujubae fructus, Radix oryzae glutinosae, and calcined oyster shells. The traditional Chinese medicine composition can also be used in combination with a 5-hydroxytryptamine reuptake inhibitor antidepressant.

Description

Application of traditional Chinese medicine compositions in auxiliary preparation of drugs for the treatment of depression Technical field

The invention relates to the field of traditional Chinese medicine, and in particular to the use of a traditional Chinese medicine composition in assisting in the preparation of drugs for treating depression.

Background technique

Depression is a group of mental illnesses with significant and lasting changes in mood as the basic clinical manifestations, often accompanied by corresponding changes in thinking and behavior. With the changes in the spectrum of human diseases and changes in life patterns, the incidence of depression is increasing year by year. It is known as the "cold" of psychiatry and has become one of the most common diseases of the mental system, seriously threatening people's health and safety. lives, resulting in serious socioeconomic burdens. The latest survey results released by the World Health Organization (WHO) show that the incidence of depression worldwide is about 3.1%. There are currently about 340 million patients with depression in the world. On average, about 1 in 20 people has suffered from depression. 13% to 20% of people have experienced depression once in their lives. In 2005, the incidence of depression reached 10% of the total population. Currently, depression ranks fourth among the most common diseases in the world. In the next 20 years, depression will rise to become the second most common disease in the world.

There are many classifications of existing treatment models and methods for depression, but most of them can be classified into two models: biological treatment and psychological treatment. Biological treatments include drug therapy, electroconvulsive therapy, phototherapy, etc.; psychological treatments include supportive psychotherapy, interpersonal psychotherapy, cognitive behavioral therapy, psychomusic therapy, etc. Among them, drug treatment is currently the main method. Since the 1960s, with the advent of a variety of antidepressant drugs, how to choose the appropriate antidepressant drug has become an important issue in clinical practice. Commonly used types of antidepressant drugs include: melatonin drugs, agomelatine, tianeptine, natural antidepressants, and neurotrophic factor drugs. At present, chemical drugs have obvious effects in the treatment of depression. However, chemically synthesized antidepressants can cause serious toxic and adverse reactions after long-term use. They also have problems such as narrow antidepressant spectrum, easy relapse, and low recovery rate. Due to shortcomings such as slow onset of effect and dose dependence, currently existing antidepressant drugs still cannot meet treatment needs.

Contents of the invention

Based on this, the present invention provides the application of a traditional Chinese medicine composition in the preparation of drugs for the auxiliary treatment of depression. The traditional Chinese medicine composition has obvious effects, low toxic and side effects, and is not prone to recurrence.

The present invention is realized through the following technical solutions.

Application of a traditional Chinese medicine composition in the preparation of drugs for the auxiliary treatment of depression. The traditional Chinese medicine composition includes the following raw materials: astragalus root, floating wheat, jujube, glutinous rice root and calcined oyster.

In one embodiment, the traditional Chinese medicine composition includes the following raw materials in terms of parts by mass: 18 to 28 parts of Astragalus membranaceus, 25 to 35 parts of floating wheat, 18 to 28 parts of jujube, 25 to 35 parts of glutinous rice root and 50 to 50 parts of glutinous rice root. 70 servings of roasted oysters.

In one embodiment, the traditional Chinese medicine composition includes the following raw materials in parts by mass: 20-25 parts of Astragalus membranaceus, 28-33 parts of floating wheat, 20-25 parts of jujube, 28-33 parts of glutinous rice root and 55-55 parts of glutinous rice root. 65 servings of roasted oysters.

In one embodiment, the traditional Chinese medicine composition includes the following raw materials in terms of parts by mass: 20-22 parts of Astragalus membranaceus, 29-31 parts of floating wheat, 20-22 parts of jujube, 29-31 parts of glutinous rice root and 58-31 parts of glutinous rice root. 62 servings of roasted oysters.

In one embodiment, the traditional Chinese medicine composition is an antihidrosis preparation.

In one embodiment, the preparation method of the traditional Chinese medicine composition includes the following steps:

Decoct astragalus, floating wheat, jujube and glutinous rice roots, and filter to prepare the first filtrate;

Boil the calcined oysters and filter them to prepare the second filtrate;

The first filtrate and the second filtrate are combined, concentrated, then mixed with alcohol and filtered.

In one embodiment, adjunctive treatment of depression involves combined treatment with a selective serotonin reuptake inhibitor.

In one embodiment, the selective serotonin reuptake inhibitor is selected from one of fluoxetine, paroxetine, sertraline, venlafaxine, citalopram and escitalopram or Various.

In one embodiment, the components of the drug for assisting the treatment of depression also include pharmaceutically acceptable excipients.

In one embodiment, the dosage form of the drug for assisting the treatment of depression is granules.

Compared with the prior art, the application of the traditional Chinese medicine composition of the present invention in the preparation of drugs for the auxiliary treatment of depression has the following beneficial effects:

The present invention found through research that the traditional Chinese medicine composition including astragalus, floating wheat, jujube, glutinous rice root and calcined oyster is different from the traditional Chinese patent medicine mainly used to "relieve depression" to treat depression. It is used to nourish qi and nourish yin. It is a traditional Chinese medicine composition that mainly treats depression. It has the advantages of obvious effect, low toxic and side effects, and difficulty in relapse for auxiliary treatment of depression.

Furthermore, the traditional Chinese medicine composition of the present invention combined with a selective serotonin reuptake inhibitor antidepressant is significantly more effective in treating depression than the selective serotonin reuptake inhibitor antidepressant alone. It is reflected in its higher effectiveness and faster onset of effect, which can shorten the onset time of selective serotonin reuptake inhibitor antidepressants. It can also reduce extrapyramidal and other side effects, and has good safety.

Description of drawings

Figure 1 is a graph of the average difference in MADRS scores between groups provided by the present invention;

Figure 2 is a graph of the MADRS score effectiveness between groups provided by the present invention;

Figure 3 is a graph showing the decrease in CSSRS, BAS and AIMS scores between groups provided by the present invention.

Detailed ways

In order to facilitate understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. Preferred embodiments of the invention are shown in the accompanying drawings. However, the invention may be embodied in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that a thorough understanding of the present disclosure will be provided.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which the invention belongs. The terminology used herein in the description of the invention is for the purpose of describing specific embodiments only and is not intended to limit the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The invention provides the use of a traditional Chinese medicine composition in preparing drugs for the auxiliary treatment of depression. The traditional Chinese medicine composition includes the following raw materials: astragalus root, floating wheat, jujube, glutinous rice root and calcined oyster.

In a specific example, in terms of parts by mass, the traditional Chinese medicine composition includes the following raw materials: 18-28 parts of Astragalus membranaceus, 25-35 parts of floating wheat, 18-28 parts of jujube, 25-35 parts of glutinous rice root and 50-70 parts Baked oysters.

In a specific example, in terms of parts by mass, the traditional Chinese medicine composition includes the following raw materials: 20-25 parts of Astragalus membranaceus, 28-33 parts of floating wheat, 20-25 parts of jujube, 28-33 parts of glutinous rice root and 55-65 parts Baked oysters.

In a specific example, in terms of parts by mass, the traditional Chinese medicine composition includes the following raw materials: 20-22 parts of Astragalus membranaceus, 29-31 parts of floating wheat, 20-22 parts of jujube, 29-31 parts of glutinous rice root and 58-62 parts Baked oysters.

In a specific example, the traditional Chinese medicine composition is an antihidrosis preparation.

In a specific example, the preparation method of the traditional Chinese medicine composition includes the following steps:

Decoct astragalus, floating wheat, jujube and glutinous rice roots, and filter to prepare the first filtrate;

Boil the calcined oysters and filter them to prepare the second filtrate;

The first filtrate and the second filtrate are combined, concentrated, then mixed with alcohol and filtered.

In one specific example, adjunctive treatment of depression refers to combined treatment with a selective serotonin reuptake inhibitor.

In a specific example, the selective serotonin reuptake inhibitor is selected from one or more of fluoxetine, paroxetine, sertraline, venlafaxine, citalopram and escitalopram .

In a specific example, the components of the drug for assisting the treatment of depression also include pharmaceutically acceptable excipients.

In a specific example, the dosage form of the medication for assisting the treatment of depression is granules.

The application of the traditional Chinese medicine composition of the present invention in preparing drugs for the auxiliary treatment of depression will be further described in detail below with reference to specific examples. The raw materials used in the following examples are all commercially available products unless otherwise specified.

Example 1

This embodiment provides an application experiment of a traditional Chinese medicine composition in the preparation of drugs for the auxiliary treatment of depression, specifically as follows:

1. Purpose The main purpose of this example is to test the hypothesis that aphrodisiac combined with SSRI antidepressants is more effective than SSRI antidepressants alone for the acute treatment of depression. The Montgomery Depression Rating Scale (MADRS) total score is calculated from Changes from baseline to 8 weeks were measured.

Test the hypothesis that antihidrosis combined with SSRI antidepressants is more effective than SSRI antidepressants alone for symptoms of autonomic nervous system dysfunction such as excessive sweating and dreaminess.

2. Objects and methods

2.1 Research objects: A total of 102 patients with acute episodes of depressive disorder who were outpatients and inpatients in the Third Affiliated Hospital of Sun Yat-sen University from October 2016 to December 2020 were collected. Excluding those who fell off for some reason, did not take the medicine once, and did not complete a complete visit, there were 5 people in the sweating and cessation group and 2 people in the control group.

2.1.1 Inclusion criteria:

① Male or female outpatients or inpatients, 18-65 years old; ② Meet the diagnostic criteria of single episode or recurrent unipolar depressive disorder without psychotic symptoms according to DSM-IV-TR clinical evaluation. The diagnostic conclusion needs to be confirmed through a structured diagnostic interview using the Mini International Neuropsychiatric Interview (MINI) depression module and mental disorders and mood disorders (with psychotic characteristics module); ③ Women of childbearing potential must agree to participate in the study during and at the end Use a medically approved method of contraception or refrain from sexual activity for one month after a dose of study drug. ④ The researcher judges to be reliable and has sufficient understanding to conduct all tests or examinations required by the trial protocol, understand the nature of the research, and sign the informed consent form; ⑤ The total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) ≥ 22; ⑥No unstable and serious physical diseases.

2.1.2 Exclusion criteria:

① Diagnosed with Parkinson's disease or related disorders; ② According to DSM-IV-TR criteria, currently or have been diagnosed with any of the following diseases in life: schizophrenia, schizophreniform disorder, schizoaffective disorder, Delusional disorder, mental disorder not otherwise specified, bipolar I or II disorder, delirium of any type, dementia of any type, any mental disorder due to systemic medical illness (unless there is clear evidence that the patient has been misdiagnosed) ; ③ Current diagnosis of postpartum depression or seasonal depressive disorder according to DSM-IV-T criteria; ④ Paranoid, schizophrenic, schizotypal, antisocial or borderline personality disorder according to DSM-IV-TR criteria (Axis II) as a comorbidity or principal diagnosis; ⑤ Psychotic symptoms within one month of visit based on clinical judgment based on MINI results completed at Visit 1; ⑥ Substance dependence/abuse (excluding nicotine or coffee (Due to dependence); ⑦ The researcher determines that there is a strong or active idea of suicide; ⑧ Pregnant or lactating women; ⑨ Suffering from acute angle-closure glaucoma; ⑩ A history of allergy to SSRI antidepressants or sweating in the past;

Have received electroconvulsive therapy (MECT) during this depressive episode, or have a history of failure of MECT therapy after a sufficient course of treatment;

If the patient receives psychotherapy or light therapy and requests to change the frequency, intensity or termination of the treatment during the study. Note: Patients who are not receiving any of these treatments at study entry cannot initiate any of these treatments during the study period;

Received monoamine oxidase inhibitor (MAIO) treatment within 1 month before participating in the study.

2.1.3 Termination:

1. If a patient is judged to have violated the exclusion criteria after entering the study, the patient will be terminated from the study at the next visit (or sooner if it is a safety exclusion criterion);

2. Patients need to use more than one benzodiazepine at the same time;

3. The researcher believes that the patient should withdraw;

4. The patient requests to withdraw from the study;

5. For any reason, the patient requires the use of other therapeutic agents that have been proven to be effective in the treatment of the study indications. Terminate the study before taking a new agent;

6. The patient is pregnant;

7. The patient withdraws his or her informed consent to participate in the study;

2.2 Observation indicators

2.2.1 Montgomery Depression Rating Scale (MADRS)

The primary efficacy endpoint and several secondary efficacy endpoints were based on the total MADRS score.

The MADRS is designed for use by psychiatrists to rate the overall severity of depressive symptoms in patients with depression. This scale is widely used in antidepressant clinical drug trials and has been found to be as sensitive as the Hamilton Depression Rating Scale in determining antidepressant effectiveness.

The MADRS has 10 items (observed depression, self-reported depression, inner tension, decreased sleep, decreased appetite, difficulty concentrating, fatigue, inability to feel, pessimism, and suicidal ideation). Each item is rated on a fixed scale from 0 to 6. Within each item, fixed descriptions were tried for levels 0, 2, 4, and 6 to normalize response traces. The total MADRS score ranges from 0 to 60. The higher the MADRS total score, the more severe the depressive symptoms are.

Response is defined as >50% decrease in MADRS total score from baseline and remission is defined as MADRS total score <10. Response and remission will be evaluated at each scheduled visit to determine time to first response and Time of first remission.

2.2.3.1Sheehan Disability Scale

The Sheehan Disability Scale (SDS) will be completed by patients at the beginning and end of the study and can assess the extent to which the patient's symptoms have interfered with their work/school, social life and home life/family responsibilities over the past week (Sheehan et al 1996). This scale consists of 3 items (work/study, social life/leisure activities, family life/family responsibilities). Responses to "not thinking" were graded from 0 (not at all a hindrance) to 10 (extremely a hindrance). The higher the score, the greater the impairment in each area of life. Item scores >5 are associated with significant functional impairment. The maximum total score for this scale is 30. The SDS assessment also includes two additional questions to determine: 1) how many days in the past week the patient was unable to attend school/work or perform their normal duties (days absent) because of their symptoms; 2) how many days in the past week the patient was absent Feel that his symptoms have affected his work/study efficiency (number of unproductive days).

2.2.3.2 Brief Health Questionnaire

The Brief Health Questionnaire (SF-36; second edition) is a patient self-report questionnaire designed to assess patients' perceptions of their functional health (Ware et al. 1993). The SF-36 will be completed by patients at the beginning and end of the study. It consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations due to physical problems, role limitations due to emotions, physical functioning, physical pain, mental health, social functioning, and vitality. The score of each subscale is calculated by summing the scores of each item and converting it into a score on a scale of 0-100, with higher scores indicating better health status or function. Two total scores, the physical health summary (PCS) and the mental health summary (MCS), will be constructed based on the eight SF-36 subscales. The individual scores of the eight subscales as well as the MCS and PCS will be included in the analysis.

2.2.4 Safety evaluation

Prevalence and severity of extrapyramidal symptoms (EPS) assessed using the Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS), and suicidality assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) The incidence and severity of related thoughts and behaviors.

2.2.4.2 Barnes Akathisia Scale

The Barnes Akathisia Scale (BAS) is used to assess drug-induced akathisia, observable movement restlessness, and the patient's combined perception of restlessness and distress associated with akathisia (Barnes 1989). The BAS consists of the following three items: an objective assessment of akathisia symptoms; the patient's supervisory perception of inner restlessness; and an overall clinical assessment of akathisia. The first two items are scored using a 5-point scale from 0 (no akathisia) to 5 (severe akathisia).

2.2.4.3 Abnormal involuntary movement scale

The Abnormal Involuntary Movement Scale (AIMS) is a 12-item scale designed to assess the presence and severity of movement disorders throughout the body and in different parts of the body through a standardized examination procedure (Guy 1976; Munetz and Benjamin 1988). Items 1 to 8 are scored using a 5-point scale from 0 (no dyskinesia) to 4 (severe dyskinesia). For each of these items, score the highest level of spontaneous abnormality observed on examination, with the severity of abnormal movements occurring during stimulation (e.g., finger tapping) being scored one point lower than those occurring spontaneously (McEvoy 2000 ). The 9th item assesses the patient's functional loss due to abnormal movement, and the 10th item assesses the patient's awareness of abnormal movement and accompanying distress. Items 9 and 10 are scored using a 5-point scale from 0 (no or no awareness) to 4 (severe or awareness, severe distress). The 11th and 12th items are yes/no questions about the patient's dental condition. The total score is the sum of the 12 items, so the possible total score range is 0-42. The higher the total score, the more severe the movement disorder.

2.2.5 Columbia Suicide Severity Scale

All patients being treated with antidepressants for any indication should be appropriately monitored and observed closely for clinical exacerbations, suicidality, and unusual behavioral changes, particularly during the initial months of drug treatment or during When dosage is changed. In this study, the Columbia-Suicide Severity Rating Scale (C-SSRS) will be completed at each scheduled visit starting at Visit 2 to assess suicidal ideation and behaviors. In addition, investigators should inform patients, families, and caregivers of unusual changes in patient behavior—such as worsening depression or suicidal ideation—and report such symptoms to investigators, especially if these symptoms are severe, occur suddenly, or are not Part of the patient's existing symptoms.

The Columbia-Suicide Severity Scale (C-SSRS) assesses the presence, severity, and frequency of suicidal thoughts and behaviors (Posner et al. 2007). The scale includes suggested questions to ask for information needed to determine whether suicidal ideation or behavior is occurring.

2.3 Treatment methods

The patients in the control group were treated with SSRI antidepressants alone, and the patients in the Xuhanting group were treated with Xuhanting in combination with SSRI antidepressants. In the two treatment groups, the starting dose of SSRI antidepressants is shown in Table 1, and the starting dose of Xuhanting is used according to the instructions, that is: taken with boiled water, 10 grams at a time, 3 times a day. Both groups continued treatment for 8 weeks, with a total of 6 visits during this period. Among them, visit 1 is the 0th day of treatment; visits 2-6 are the 7th, 14th, 21st, 28th and 56th days of treatment respectively. During study treatment, dose level 1 is the lowest allowable dose level for the 4 weeks prior to study treatment. Dose level 2 is the lowest allowable dose level for weeks 5-8 unless the patient has responded to dose level 1 by the end of week 4. Patients who are unable to tolerate the lowest study drug dose level during study treatment will be discontinued from the study.

According to the research of Sackheim (2001) and Virani et al. (2009) and combined with relevant Chinese drug instructions, the acceptable antidepressants and sufficient doses for this study are shown in Table 1:

Table 1

3Statistical analysis

SPSS 22.0 statistical software was used for processing, and the measurement data were tested by Shapiro-Wilk for normality and showed a normal distribution.

Otherwise, it is expressed as the median; the comparison of the means of the two groups of numerical variable data uses the t test or the rank sum test. If it conforms to the normal distribution, the t test is used, otherwise the rank sum test is used; the chi-square test is used for the categorical variables; for the baseline Uneven indicators were corrected by covariance analysis, with different treatment methods as fixed factors and baseline values as covariates, thereby eliminating interference caused by uneven baselines. P<0.05 was considered a statistically significant difference.

Results: Except for age, there were no significant differences in other demographic characteristics between the groups. The experimental results showed that at baseline, there was no significant difference in MADRS, SF-36, and SDS between groups (p>0.05). After 8 weeks of treatment, compared with the control group, combined use of Xuhanting could significantly reduce the patient's MADRS score (p=0.048), and the 95% CI of the reduced score was -5.50 (8.15, -2.85). Compared with the control group, at visit points 2-6 (i.e., 7 days, 14 days, 21 days, 28 days and 56 days after enrollment), combined use of Xuhanting can significantly increase the average MADRS score reduction ( p<0.05). After 8 weeks of treatment, compared with the control group, combined use of Xuhanting could significantly reduce the patient's SDS score (p=0.013) and SF-36 score (p=0.006). In visits 3-5 (i.e. 14 days, 21 days and 28 days after enrollment), compared with the control group, combined use of Xuhanting can significantly improve the treatment effectiveness within the group (p<0.05). In terms of safety, there was no significant difference in the decrease in CSSRS in the Xuhan Stop group; compared with the control group, combined use of Xuhan Stop at visit points 3-6 (i.e., 14 days, 21 days, 28 days and 56 days after enrollment) had a significant Reduce BAS and AIMS scores (p<0.01).

1. General demographic characteristics between groups

As shown in Table 2, there were 46 subjects in the Xuhantan group and 49 subjects in the control group. There were no significant differences in gender ratio, height, weight and BMI between groups. However, there was a significant difference in age (p<0.01).

Table 2

2. Effect evaluation of main efficacy indicators and secondary efficacy indicators between groups

The primary outcome index of this trial is the average change in the Montgomery Depression Rating Scale (MADRS) total score after taking the drug for 8 weeks compared with baseline; the secondary outcome index includes the average change in MADRS at previous visit points. Mean change in SDS and SF-36 total score from baseline. As shown in Table 3, there was no significant difference in MADRS baseline between groups (p>0.05). After 8 weeks of treatment, compared with the control group, combined use of Xuhanting could significantly reduce the patient's MADRS score (p=0.048), and the 95% CI of the reduced score was -5.50 (8.15, -2.85). As shown in Figure 1, co-administration of Xuhanting significantly enhanced the mean change in MADRS compared with the control group at different visit points (p<0.05).

As shown in Table 3, there was no significant difference in the baseline of SF-36 and SDS scales between groups (p>0.05). After 8 weeks of treatment, compared with the control group, combined use of Xuhanting can significantly reduce the patient's SDS score (p=0.013), and the 95% CI of the score reduction value is -4.02 (-6.04, -2.00); it can significantly reduce the patient's SDS score (p=0.013). SF-36 score (p=0.006), the 95% CI of the reduced score was 3.05 (0.90, 5.21).

Table 3. Baseline values of MADRS, SF-36 and SDS scales, and average changes from baseline to end point after interpolation using the last observation carried forward method.

*The analysis of variance results show analysis of covariance (ANCOVA), using the baseline of the corresponding scale as a covariate, and examining the interaction effect between baseline and group to obtain the corresponding statistics.

3. Effect evaluation of main efficacy indicators and secondary efficacy indicators between groups

Effective was defined as a ≥50% decrease in MADRS total score from baseline. Effectiveness was evaluated at each planned visit to determine effectiveness between groups. As shown in Figure 2, at visits 3-5 (i.e. 14 days, 21 days and 28 days after enrollment), compared with the control group, combined use of Xuhanting can significantly improve the treatment effectiveness within the group (p<0.05) ; After 8 weeks of treatment, the effective rates of the treatment group and the control group were 95.7% (44/46) and 83.7% (41/49) respectively. The treatment group showed a trend of improving the effective rate, but there was no significant difference ( p=0.057).

4. Combined SSRI dosage between groups at baseline and study endpoint

As shown in Table 4, at baseline, compared with the control group, the SSRI dosage in the Xuhanting group was significantly less than that in the control group (p<0.01). Because there was a large difference in baseline, analysis of covariance was used to balance the SSRI doses between the two groups. Compared with the control group, combined use of Xuhanting had a tendency to reduce the dose of combined SSRIs, but there was no significant difference (p>0.05).

Table 4 Baseline and study endpoint SSRI combined dosage between groups

*The analysis of variance results show analysis of covariance (ANCOVA), using the baseline of the corresponding scale as a covariate, and examining the interaction effect between baseline and group to obtain the corresponding statistics. At baseline, compared with the control group, the SSRI dosage in the Xuhanting group was significantly less than that in the control group (p<0.01).

5. Security status of CSSRS, BAS and AIMS between groups

As shown in Figure 3, at baseline, compared with the control group, there was no significant difference in the decrease in CSSRS in the Xuhanting group. Compared with the control group, combined use of antiperspirant therapy at visit points 3-6 (i.e., 14 days, 21 days, 28 days and 56 days after enrollment) significantly reduced BAS and AIMS scores (p<0.01).

The technical features of the above embodiments can be combined in any way. To simplify the description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, All should be considered to be within the scope of this manual.

The above-mentioned embodiments only express several implementation modes of the present invention to facilitate a specific and detailed understanding of the technical solutions of the present invention, but they should not be construed as limiting the scope of protection of the invention patent. It should be noted that, for those of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. It should be understood that technical solutions obtained by those skilled in the art through logical analysis, reasoning or limited testing based on the technical solutions provided by the present invention are within the protection scope of the appended claims of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the contents of the appended claims, and the description and drawings may be used to interpret the contents of the claims.

Claims (10)

1. An application of a traditional Chinese medicine composition in the preparation of drugs for the auxiliary treatment of depression. The traditional Chinese medicine composition includes the following raw materials: astragalus root, floating wheat, jujube, glutinous rice root and calcined oyster.
2. The application of the traditional Chinese medicine composition in preparing drugs for the auxiliary treatment of depression according to claim 1, characterized in that, in terms of parts by mass, the traditional Chinese medicine composition includes the following raw materials: 18 to 28 parts of Astragalus membranaceus, 25 to 35 parts of Flos Vitis vinifera. Wheat, 18-28 parts jujube, 25-35 parts glutinous rice root and 50-70 parts burnt oysters.
3. The application of the traditional Chinese medicine composition in the preparation of drugs for the auxiliary treatment of depression according to claim 2, characterized in that, in terms of parts by mass, the traditional Chinese medicine composition includes the following raw materials: 20 to 25 parts of Astragalus membranaceus, 28 to 33 parts of Flos Vitis vinifera. Wheat, 20-25 parts jujube, 28-33 parts glutinous rice root and 55-65 parts burnt oyster.
4. The application of the traditional Chinese medicine composition in preparing drugs for adjusting intestinal microecology according to claim 3, characterized in that, in terms of parts by mass, the traditional Chinese medicine composition includes the following raw materials: 20 to 22 parts of Astragalus membranaceus, 29 to 31 parts of Astragalus membranaceus Floating wheat, 20-22 parts jujube, 29-31 parts glutinous rice root and 58-62 parts burnt oysters.
5. The application of the traditional Chinese medicine composition in the preparation of drugs for the auxiliary treatment of depression according to claim 1, characterized in that the traditional Chinese medicine composition is an antihidrosis preparation.
6. The application of the traditional Chinese medicine composition in the preparation of drugs for the auxiliary treatment of depression according to claim 1, characterized in that the preparation method of the traditional Chinese medicine composition includes the following steps:

   Decoct astragalus, floating wheat, jujube and glutinous rice roots, and filter to prepare the first filtrate;

   Boil the calcined oysters and filter them to prepare the second filtrate;

   The first filtrate and the second filtrate are combined, concentrated, then mixed with alcohol and filtered.
7. The application of the traditional Chinese medicine composition in preparing drugs for the auxiliary treatment of depression according to claim 1, wherein the auxiliary treatment of depression refers to combined treatment with a selective serotonin reuptake inhibitor.
8. The application of the traditional Chinese medicine composition in preparing drugs for the auxiliary treatment of depression according to claim 7, wherein the selective serotonin reuptake inhibitor is selected from the group consisting of fluoxetine, paroxetine, sertraline, One or more of lafaxine, citalopram and escitalopram.
9. The application of the traditional Chinese medicine composition according to any one of claims 1 to 8 in the preparation of drugs for the auxiliary treatment of depression, characterized in that the components of the drug for the auxiliary treatment of depression also include pharmaceutically acceptable auxiliary materials.
10. The application of the traditional Chinese medicine composition according to any one of claims 1 to 8 in the preparation of drugs for the auxiliary treatment of depression, characterized in that the dosage form of the drug for the auxiliary treatment of depression is granules.

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