Medicine for treating depression disease and preparation method thereof

Abstract

The invention relates to a medicine for treating depression diseases and a preparation method thereof, belongs to the technical field of traditional Chinese medicine preparation, and aims at solving the problems that an existing traditional Chinese medicine prescription is not remarkable enough in curative effect, indefinite in action mechanism and unreasonable in formula. According to the technical scheme, the medicine is prepared from 8-12 parts of radix bupleuri, 4-6 parts of rhizoma cyperi, 8-10 parts of pericarpium citri reticulatae, 8-12 parts of radix scutellariae, 8-12 parts of radix curcumae, 8-12 parts of fructus alpiniae oxyphyllae, 8-12 parts of polygala tenuifolia, 8-10 parts of chinaberry seeds, 8-12 parts of rhizoma anemarrhenae, 7-9 parts of coptis chinensis, 8-12 parts of fructus gardeniae, 12-18 parts of spina date seeds, 8-12 parts of hairyvein agrimony, 7-9 parts of cortex acanthopanacis, 8-12 parts of fructus aurantii, 5-7 parts of liquorice, 12-18 parts of radix rehmanniae, 8-12 parts of cortex magnoliae officinalis and 8-12 parts of semen boitae. The preparation method comprises the following steps: crushing the radix bupleuri, rhizoma cyperi and other components, performing water extraction and concentration, performing alcohol extraction and concentration on the fructus alpiniae oxyphyllae, polygala tenuifolia and other components, and mixing to obtain clear paste. The traditional Chinese medicine composition is mainly used for treating depression.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a medicine for treating depression and a preparation method thereof. BACKGROUND

[0002] In the theory of traditional Chinese medicine, depression is mostly classified into the category of "liver qi stagnation", and its onset is closely related to the dysfunction of liver, spleen and heart. The main manifestations are low mood, decreased interest, slow thinking, self-blame and self-accusation, which seriously affect the quality of life and social function of patients.

[0003] At present, the methods for treating depression in clinic mainly include western medicine treatment, psychological treatment and traditional Chinese medicine treatment. The western medicine treatment has the problems of large side effects, easy drug resistance and dependence, etc., although it has a rapid effect. Some patients will have adverse reactions such as drowsiness, dry mouth and gastrointestinal discomfort after taking the medicine. The traditional Chinese medicine treatment has the advantages of overall conditioning and small side effects, but the existing traditional Chinese medicine prescriptions have the problems of insufficient curative effect, unclear mechanism and unreasonable formula, which are difficult to meet the clinical treatment needs. Therefore, it has important clinical significance and application value to develop a traditional Chinese medicine for treating depression with exact curative effect, small side effect and scientific formula. SUMMARY

[0004] The present application provides a medicine for treating depression and a preparation method thereof, and the technical problems to be solved are to improve the problems of the existing traditional Chinese medicine prescriptions, such as insufficient curative effect, unclear mechanism and unreasonable formula.

[0005] In order to achieve the above application purposes, the technical scheme adopted by the present application is as follows:

[0006] In a first aspect, a medicine for treating depression is prepared from the following components by weight: 8-12 parts of Radix Bupleuri, 4-6 parts of Rhizoma Cyperi, 8-10 parts of Pericarpium Citri Reticulatae Viride, 8-12 parts of Radix Scophulariae, 8-12 parts of Radix Curcumae, 8-12 parts of Fructus Evodiae, 8-12 parts of Radix Notoginseng, 8-12 parts of Radix Pseudostellariae, 7-9 parts of Radix Ampelopsis, 8-12 parts of Fructus Aurantii, 12-18 parts of Semen Ziziphi Spinosae, 8-12 parts of Herba Viola, 7-9 parts of Radix et Rhizoma Acanthopanacis Senticosi, 5-7 parts of Radix Glycyrrhizae, 12-18 parts of Radix Moutan, 8-12 parts of Radix Pteroxygoni Multifidi, 8-12 parts of Semen Platycladi.

[0007] Further, the medicine is prepared from the following components by weight: 10 parts of Radix Bupleuri, 5 parts of Rhizoma Cyperi, 9 parts of Pericarpium Citri Reticulatae Viride, 10 parts of Radix Scophulariae, 10 parts of Radix Curcumae, 10 parts of Fructus Evodiae, 10 parts of Radix Notoginseng, 10 parts of Radix Pseudostellariae, 9 parts of Rhizoma Ampelopsis, 10 parts of Radix et Rhizoma Acanthopanacis Senticosi, 8 parts of Radix Glycyrrhizae, 15 parts of Radix Moutan, 10 parts of Radix Pteroxygoni Multifidi, 10 parts of Semen Platycladi.

[0008] In a second aspect, a method for preparing a medicament for treating depression comprises the following steps:

[0009] S1, each Chinese medicine component is weighed according to claim 1 or 2, and is respectively pulverized and passed through an 80-120 mesh sieve to obtain each Chinese medicine powder;

[0010] S2, Bupleurum, Cyperus, Pericarpium Citri Reticulatae, Scutellaria, Radix Curcumae, Semen Pruni, Anemarrhena, Rhizoma Coptidis, Gardenia, Fructus Aurantii, Magnolia officinalis, and Semen Platycladi are mixed, 8-10 times the amount of water is added, and after being soaked for 30-60 min, heating is performed to boiling, a state of slight boiling is maintained for 1.5-2 h, and filtration is performed to obtain a first filtrate and a residue;

[0011] S3, 6-8 times the amount of water is added to the residue, heating is performed to boiling, a state of slight boiling is maintained for 1-1.5 h, and filtration is performed to obtain a second filtrate;

[0012] S4, the first filtrate and the second filtrate are combined, and vacuum concentration is performed to a clear extract with a relative density of 1.10-1.15;

[0013] S5, Fructus Schisandrae, Polygala, Semen Ziziphi Spinosae, Herba Impatientis, Radix Acanthopanacis Senticosi, Radix Glycyrrhizae, and Radix Rehmanniae are mixed, 6-8 times the amount of 70%-80% ethanol is added, and after being soaked for 30-60 min, heating is performed to reflux extraction for 1-1.5 h, and filtration is performed to obtain a first alcohol extract and a residue;

[0014] S6, 4-6 times the amount of 70%-80% ethanol is added to the residue, heating is performed to reflux extraction for 0.5-1 h, and filtration is performed to obtain a second alcohol extract;

[0015] S7, the first alcohol extract and the second alcohol extract are combined, ethanol is recovered under vacuum, and concentration is performed to a clear extract with a relative density of 1.10-1.15;

[0016] S8, the water extract clear extract obtained in step S4 and the alcohol extract clear extract obtained in step S7 are uniformly mixed to obtain the medicament.

[0017] Further, in step S1, the mesh number of the sieve is 100.

[0018] Further, in step S2, 9 times the amount of water is added, soaking is performed for 45 min, and a state of slight boiling is maintained for 1.8 h.

[0019] Further, in step S3, 7 times the amount of water is added, and a state of slight boiling is maintained for 1.2 h.

[0020] Further, in step S5, 7 times the amount of 75% ethanol is added, soaking is performed for 45 min, and heating is performed to reflux extraction for 1.2 h.

[0021] Further, in step S6, 5 times of 75% ethanol is added, and heated to reflux extraction for 0.8h.

[0022] Advantages:

[0023] 1. The formula is scientific and reasonable.

[0024] From the scientific nature of the formula, the drug is based on the core pathogenesis of "stagnation of liver qi" in TCM theory of depression, combined with the pathogenesis of modern medicine that stress stimulation leads to low mood, hormone imbalance (such as decreased adrenaline), and precise compatibility. The three ingredients of Chaihu, Xiangfu and Chenpi work together to relieve liver stagnation, among which Chenpi has the function of invigorating the spleen and stomach, can promote drug absorption and reduce the metabolic burden of the body, and embodies the overall conditioning thinking of "treating liver and considering spleen"; Huangling and Yujin help liver and gallbladder to discharge and regulate the imbalance of viscera function; Yiziren, Yuzhi, Zhizi and Suanzaoren work together to regulate the nervous system and hormone endocrine of the body, achieve the effects of opening the orifices, benefiting the heart and soothing the nerves; In view of the characteristics of most qi-regulating drugs being dry, Huangling, Shengdi and Zhimu are added to nourish yin and dryness, neutralize dryness, and avoid damaging yin; Chuanhoupu can not only regulate qi, but also lead the medicine upward to enhance the concentration of the drug in the lesion; The combination of Zhisheng and Chenpi further strengthens the spleen- invigorating effect and ensures the source of blood and qi production. The 18 kinds of traditional Chinese medicines play their own roles and cooperate with each other, and the whole formula closely follows the principles of "relieving liver and regulating qi, nourishing yin and dryness, and soothing the nerves and benefiting the heart", with strict compatibility logic, in line with the theory of TCM syndrome differentiation and treatment and modern pathophysiological characteristics, so the formula is scientific and reasonable.

[0025] 2. It has definite therapeutic effect.

[0026] From the exactness of the curative effect, through clinical comparative test verification, the total effective rate of the drug prepared by the embodiment of the application in treating depression can reach 90.0%-96.7%, which is significantly higher than that of the marketed traditional Chinese medicine prescription (70.0%), western medicine antidepressant (80.0%) and blank control group (10.0%), and can effectively reduce the Hamilton Depression Scale (HAMD) score, significantly improve the core symptoms such as low mood and decreased interest, and fully prove its exact therapeutic effect on depression.

[0027] 3. Small side effects.

[0028] From the safety of side effects, the test data shows that the incidence of adverse reactions of the drug is only 3.3%-6.7%, which is much lower than that of western medicine antidepressants (20.0%) and some marketed traditional Chinese medicine prescriptions (10.0%), and no serious adverse reactions have been found. This is due to the mild nature of traditional Chinese medicine compatibility: the dryness of the qi-regulating drugs is neutralized by the yin-nourishing and dryness-soothing drugs such as Huangling, Shengdi and Zhimu, reducing the stimulation to the body; The spleen-invigorating and harmonizing drugs such as Chenpi and Gancao reduce the burden on the gastrointestinal tract, so that the drug can maximize the therapeutic effect while minimizing the side effects.

[0029] 4. The effect of the "liver-spleen" closed-loop synergy compatibility of the liver-soothing drugs and spleen-strengthening drugs: The existing traditional Chinese medicine treatment of depression often ignores the theory of "liver wood invading spleen earth", leading to weak spleen and stomach affecting drug absorption and qi and blood production, and aggravating depressive somatic symptoms. The application adds dried tangerine or orange peel (8-10 parts, close to the weight parts of bupleurum), fructus aurantii (8-12 parts), and licorice (5-7 parts) on the basis of bupleurum and turmeric liver-soothing module. The dried tangerine or orange peel promotes drug absorption, and the licorice reduces gastrointestinal irritation. This compatibility improves the somatic depressive symptoms such as "fatigue, loss of appetite" of the depression patients, reduces the risk of "somatic discomfort inducing depression recurrence", and realizes the synergy effect of "liver-soothing-spleen-strengthening-depression treatment".

[0030] 5. The effect of the linkage compatibility of multi-target calming drugs and liver-soothing drugs: The existing calming traditional Chinese medicine only targets the "insomnia" symptoms of depression patients, and the mechanism is unclear, which cannot improve the core symptoms such as "slowed thinking and decreased interest". The application selects jujube seed (12-18 parts, the highest weight part among calming drugs), polygala (8-12 parts), yizhi-fruit (8-12 parts), and bai-fruit (8-12 parts). The jujube seed and bai-fruit relieve central nervous inhibition, the polygala regulates the cholinergic system in the brain to improve slowed thinking, and the yizhi-fruit regulates the HPA axis to relieve decreased interest. The compatibility cooperates with liver-soothing drugs to improve "restless mind" from the root cause of the disease, improves the core symptoms of depression such as "slowed thinking and decreased interest", solves the problem of "short-term sleep aid and recurrence after drug withdrawal", and realizes the durability and comprehensiveness of the calming effect.

[0031] 6. The effect of the precise combination compatibility of channel drugs and somatic symptom targets: The existing drugs for treating depression focus on mental symptoms and ignore somatic symptoms such as "chest pain and body aches", and lack of channel drugs design leads to scattered efficacy. The application adds chuanhoupu (8-12 parts) to undertake the "drug ascending" function, guide liver-soothing and calming drugs to the central nervous system, and cooperates with chuanjiangzi (8-10 parts) to regulate qi and stop pain, xianhecao (8-12 parts) to regulate qi and blood, and wujiaoku (7-9 parts) to improve body aches. The compatibility relieves the somatic symptoms such as "chest pain and body aches" of the depression patients, realizes the dual-dimension treatment of depression "mental symptoms + somatic symptoms", and meets the overall rehabilitation needs of the patients. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 The preparation method flowchart of the application. DETAILED DESCRIPTION

[0033] In order to make the content of the application more easily understood, the technical solutions in the embodiments of the application are clearly and completely described.

[0034] Example 1

[0035] A medicine for treating depression disease, which is composed of the following components in parts by weight: Radix Bupleuri 10g, Rhizoma Cyperi 5g, Pericarpium Citri Reticulatae 9g, Radix Scutellariae 10g, Radix Notoginseng 10g, Fructus Evodiae 9g, Radix Anemarrhenae 10g, Rhizoma Coptidis 8g, Fructus Gardeniae 10g, Semen Ziziphi Spinosae 15g, Herba Agrimoniae 10g, Cortex Radicis Acanthopanacis 8g, Fructus Aurantii 10g, Radix Glycyrrhizae 6g, Radix Rehmanniae 15g, Radix Magnoliae Officinalis 10g, Semen Platycladi 10g.

[0036] The preparation method comprises the following steps:

[0037] S1, the components of each traditional Chinese medicine are weighed according to the above weight parts, respectively crushed, and sieved through a 100 mesh screen to obtain each traditional Chinese medicine powder;

[0038] S2, Radix Bupleuri, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Radix Scutellariae, Radix Notoginseng, Fructus Evodiae, Radix Anemarrhenae, Rhizoma Coptidis, Fructus Gardeniae, Fructus Aurantii, Radix Magnoliae Officinalis and Semen Platycladi are mixed, 9 times the amount of water is added, soaked for 45 minutes, heated to boiling, and kept in a state of micro-boiling for 1.8 hours, filtered to obtain the first filtrate and drug residue;

[0039] S3, 7 times the amount of water is added to the above drug residue, heated to boiling, and kept in a state of micro-boiling for 1.2 hours, filtered to obtain the second filtrate;

[0040] S4, the first filtrate and the second filtrate are combined, and concentrated under reduced pressure to a clear extract with a relative density of 1.12 (60°C);

[0041] S5, Fructus Evodiae, Radix Anemarrhenae, Semen Ziziphi Spinosae, Herba Agrimoniae, Cortex Radicis Acanthopanacis, Radix Glycyrrhizae and Radix Rehmanniae are mixed, 7 times the amount of 75% ethanol is added, soaked for 45 minutes, heated to reflux extraction for 1.2 hours, filtered to obtain the first alcohol extract and drug residue;

[0042] S6, 5 times the amount of 75% ethanol is added to the above drug residue, heated to reflux extraction for 0.8 hours, filtered to obtain the second alcohol extract;

[0043] S7, the first alcohol extract and the second alcohol extract are combined, ethanol is recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.12 (60°C);

[0044] S8, the water extract clear extract obtained in step S4 and the alcohol extract clear extract obtained in step S7 are mixed evenly to obtain the medicine.

[0045] Example 2

[0046] A medicine for treating depression disease, which is composed of the following components in parts by weight: Radix Bupleuri 12g, Rhizoma Cyperi 6g, Pericarpium Citri Reticulatae Viride 10g, Radix Scutellariae 12g, Radix Notoginseng 12g, Fructus Evodiae 10g, Radix Anemarrhenae 12g, Rhizoma Coptidis 9g, Fructus Gardeniae 12g, Semen Ziziphi Spinosae 18g, Herba Agrimoniae 12g, Radix et Rhizoma Acanthopanacis Senticosi 9g, Fructus Aurantii 12g, Radix Glycyrrhizae 7g, Radix Rehmanniae 18g, Radix Magnoliae Officinalis 12g, Semen Platycladi 12g.

[0047] The preparation method comprises the following steps:

[0048] S1, each traditional Chinese medicine component is weighed according to the above weight parts, respectively crushed, and sieved through a 120 mesh screen to obtain each traditional Chinese medicine powder;

[0049] S2, Radix Bupleuri, Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Notoginseng, Fructus Evodiae, Radix Anemarrhenae, Rhizoma Coptidis, Fructus Gardeniae, Fructus Aurantii, Radix Magnoliae Officinalis and Semen Platycladi are mixed, 10 times the amount of water is added, soaked for 60 minutes, heated to boiling, kept in a state of micro-boiling for 2 hours, filtered to obtain the first filtrate and dregs;

[0050] S3, 8 times the amount of water is added to the above dregs, heated to boiling, kept in a state of micro-boiling for 1.5 hours, filtered to obtain the second filtrate;

[0051] S4, the first filtrate and the second filtrate are combined, and concentrated under reduced pressure to a clear extract with a relative density of 1.15 (60°C);

[0052] S5, Fructus Evodiae, Radix Anemarrhenae, Semen Ziziphi Spinosae, Herba Agrimoniae, Radix et Rhizoma Acanthopanacis Senticosi, Radix Glycyrrhizae and Radix Rehmanniae are mixed, 8 times the amount of 80% ethanol is added, soaked for 60 minutes, heated to reflux extraction for 1.5 hours, filtered to obtain the first alcohol extract and dregs;

[0053] S6, 6 times the amount of 80% ethanol is added to the above dregs, heated to reflux extraction for 1 hour, filtered to obtain the second alcohol extract;

[0054] S7, the first alcohol extract and the second alcohol extract are combined, ethanol is recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.15 (60°C);

[0055] S8, the water extract clear extract obtained in step S4 and the alcohol extract clear extract obtained in step S7 are mixed evenly to obtain the medicine.

[0056] Example 3

[0057] A medicine for treating depression disease, which is composed of the following components in parts by weight: Radix Bupleuri 8g, Rhizoma Cyperi 4g, Pericarpium Citri Reticulatae Viride 8g, Radix Scutellariae 8g, Radix Notoginseng 8g, Fructus Evodiae 8g, Radix Anemarrhenae 8g, Radix Paeoniae Alba 8g, Radix Paeoniae Rubra 7g, Fructus Gardeniae 8g, Semen Ziziphi Spinosae 12g, Herba Agrimoniae 8g, Radix et Rhizoma Acanthopanacis Senticosi 7g, Fructus Aurantii 8g, Radix Glycyrrhizae 5g, Radix Rehmanniae 12g, Radix Phellodendri 8g, Semen Platycladi 8g.

[0058] The preparation method comprises the following steps:

[0059] S1, the components of each traditional Chinese medicine are weighed according to the above weight parts, respectively pulverized, and passed through an 80-mesh sieve to obtain each traditional Chinese medicine powder;

[0060] S2, Radix Bupleuri, Rhizoma Cyperi, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Notoginseng, Fructus Evodiae, Radix Anemarrhenae, Radix Paeoniae Alba, Radix Paeoniae Rubra, Fructus Gardeniae, Fructus Aurantii, Radix Glycyrrhizae, Radix Rehmanniae, Radix Phellodendri and Semen Platycladi are mixed, 8 times the amount of water is added, soaked for 30 min, heated to boiling, kept in a state of micro-boiling for 1.5 h, filtered to obtain the first filtrate and dregs;

[0061] S3, 6 times the amount of water is added to the above dregs, heated to boiling, kept in a state of micro-boiling for 1 h, filtered to obtain the second filtrate;

[0062] S4, the first filtrate and the second filtrate are combined, concentrated under reduced pressure to a clear extract with a relative density of 1.10 (60℃);

[0063] S5, Radix Rehmanniae, Fructus Evodiae, Semen Ziziphi Spinosae, Herba Agrimoniae, Radix et Rhizoma Acanthopanacis Senticosi, Radix Glycyrrhizae, and Radix Rehmanniae are mixed, 6 times the amount of 70% ethanol is added, soaked for 30 min, heated to reflux extraction for 1 h, filtered to obtain the first alcohol extract and dregs;

[0064] S6, 4 times the amount of 70% ethanol is added to the above dregs, heated to reflux extraction for 0.5 h, filtered to obtain the second alcohol extract;

[0065] S7, the first alcohol extract and the second alcohol extract are combined, ethanol is recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.10 (60℃);

[0066] S8, the water extract clear extract obtained in step S4 and the alcohol extract clear extract obtained in step S7 are mixed evenly to obtain the medicine.

[0067] Comparative Example 1

[0068] A commercially available anti-depression traditional Chinese medicine prescription is used, and the main components are Radix Bupleuri, Angelica sinensis, Radix Paeoniae Alba, Poria cocos, etc.

[0069] Comparative Example 2

[0070] A certain western medicine anti-depression drug (sertraline) is used.

[0071] Test Example

[0072] 180 patients with depression were selected and randomly divided into 6 groups, 30 cases in each group, which were Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group and blank control group (without using any medicine). There was no significant difference in age, gender, disease duration and other aspects (P>0.05) among the patients in each group, which were comparable.

[0073] The administration method was as follows: the patients in Example 1 group, Example 2 group and Example 3 group took the medicine prepared by Example 1, 2 and 3 of the application, respectively, 3 times a day, 10g each time; the patients in Comparative Example 1 group took a certain anti-depression traditional Chinese medicine prescription on the market, 3 times a day, 10g each time; the patients in Comparative Example 2 group took sertraline, once a day, 50mg each time; and the patients in blank control group did not use any medicine. Each group was treated for 8 weeks continuously.

[0074] Therapeutic effect determination standard:

[0075] Recovery: depression symptoms completely disappeared, and the Hamilton depression scale (HAMD) score was reduced by ≥75%;

[0076] Marked effect: depression symptoms were obviously improved, and the HAMD score was reduced by 50%-74%;

[0077] Effectiveness: depression symptoms were improved, and the HAMD score was reduced by 25%-49%;

[0078] Ineffectiveness: depression symptoms were not obviously improved or aggravated, and the HAMD score was reduced by <25%.

[0079] Total effective rate = (number of recovery cases + number of marked effect cases + number of effective cases) / total number of cases × 100%.

[0080] At the same time, the occurrence of adverse reactions (such as nausea, vomiting, dizziness, somnolence, etc.) of the patients in each group during the treatment was recorded.

[0081] The test results are shown in the following table:

[0082] From the above test results, it can be seen that the total effective rate of the medicine prepared by Example 1-3 of the application for treating depression is significantly higher than that of Comparative Example 1 group, Comparative Example 2 group and blank control group, and the incidence of adverse reactions is low, which shows that the medicine of the application has the advantages of significant curative effect and small side effect, and is worthy of clinical popularization and application.

[0083] From the perspective of formula science, the medicine for treating depression is based on the core pathogenesis of "stagnation of liver qi" in traditional Chinese medicine theory, combined with the pathogenesis of modern medicine that stress stimulation leads to low mood and hormone level imbalance (such as decrease of adrenaline), and precise compatibility is carried out. The three ingredients of Chaihu, Xiangfu and Chenpi in the prescription synergize to achieve the effect of soothing liver and relieving depression. Chenpi has the function of invigorating spleen and stomach, can promote drug absorption and reduce the metabolic burden of the body, and embodies the whole regulation thinking of "treating liver and considering spleen"; Huangling, Yujin help liver and gallbladder to discharge and regulate the imbalance of viscera function; Yizhi, Yuanzhi, Zhizi and Suanzaoren synergize to regulate the nervous system and hormone endocrine of the body, achieve the effect of opening the orifices and benefiting wisdom, and nourishing the heart and tranquilizing the mind; In view of the characteristics of most qi-regulating drugs being dry, Huangling, Shengdi and Zhimu are added to nourish yin and dryness, neutralize dryness, and avoid damaging yin; Chuanhoupu can not only regulate qi, but also lead the drug upward to improve the concentration of the drug in the lesion; The combination of Zhisheng and Chenpi further strengthens the effect of invigorating the spleen and guarantees the source of qi and blood. The 18 kinds of traditional Chinese medicines play their respective roles and synergize with each other. The whole prescription closely follows the therapeutic principle of "soothing liver and regulating qi, nourishing yin and dryness, and tranquilizing the mind and benefiting wisdom", and the compatibility logic is rigorous, which is consistent with the theory of traditional Chinese medicine syndrome differentiation and treatment and the modern pathophysiological characteristics, so the formula is scientific and reasonable.

[0084] From the perspective of exact curative effect, through clinical comparative test verification, the total effective rate of the medicine prepared by the embodiment of the present application for treating depression can reach 90.0%-96.7%, which is significantly higher than that of the marketed traditional Chinese medicine prescription (70.0%), western medicine antidepressant (80.0%) and blank control group (10.0%), and can effectively reduce the Hamilton Depression Scale (HAMD) score, significantly improve the core symptoms such as low mood and decreased interest, and fully prove its exact therapeutic effect on depression.

[0085] From the perspective of side effect safety, the test data shows that the incidence of adverse reactions of the medicine is only 3.3%-6.7%, which is much lower than that of western medicine antidepressants (20.0%) and some marketed traditional Chinese medicine prescriptions (10.0%), and no serious adverse reactions have been found. This is due to the mild nature of traditional Chinese medicine compatibility: the dryness of the qi-regulating drugs is neutralized by the yin-nourishing and dryness-soothing drugs such as Huangling, Shengdi and Zhimu, reducing the stimulation to the body; The burden of the gastrointestinal tract is reduced by the spleen-invigorating and harmonizing drugs such as Chenpi and Gancao, so that the medicine can maximize the reduction of side effects while exerting its therapeutic effect.

[0086] In addition, the persistent regulating effect of "soothing liver without damaging yin". Long-term use of conventional qi-regulating drugs can easily lead to loss of yin fluid, causing side effects such as restlessness and insomnia. However, the precise proportion of Huangling, Shengdi, Zhimu and qi-regulating drugs in this formula not only neutralizes the dryness, but also provides sustained nutrition for nerve cells through the yin-nourishing effect of Shengdi, making the effect of soothing liver and relieving depression more stable. This dynamic balance of "regulating qi and nourishing yin" cannot be achieved by a single component.

[0087] The spleen and stomach function improvement strengthens the effect of soothing the nerves. The spleen-boosting effect of Chenpi and Shicheng is not only to assist digestion, but also to provide raw materials for the synthesis of neurotransmitters in the brain by improving the absorption of nutrients by the spleen and stomach, thereby indirectly enhancing the soothing nerves effect of Suanzaoren and Ruzhizhi. In the test, the improvement rate of the formula on symptoms such as "reduced interest, slow thinking" was significantly higher than that of simple soothing nerves drugs, which verified this synergistic effect.

[0088] Balancing of low side effects and high efficiency. The antidepressant drugs of western medicine are easy to cause drowsiness and gastrointestinal discomfort due to the strong effect of single component, while the formula of the present application inhibits the irritability of qi-regulating drugs through the heat-clearing effect of Huanglian and Zhizi and the harmonizing effect of Gancao, and reduces the discomfort of the body through the mild effect of Xianhecao and Wujiapi, so that the incidence of adverse reactions is only 3.3%-6.7%, while maintaining an overall effective rate of more than 90%, achieving the unexpected balance of "high efficiency-low toxicity".

[0089] Synergistic improvement of somatic symptoms. Depressed patients often have somatic symptoms such as insomnia, fatigue, and somatic pain. In the formula, Chuanhoupu enhances central regulation by ascending, Xianhecao relieves somatic discomfort by regulating qi and blood, and the soothing nerves effect of Suanzaoren is synergistic, so that the improvement rate of somatic symptoms is significantly higher than that of simple antidepressant western medicine. This synchronous regulation of "mind-body" is an unexpected effect of the overall synergy of the formula.

[0090] As a traditional Chinese medicine with the effect of nourishing the heart and soothing the nerves in the formula, Baoziren synergizes with Suanzaoren, Ruzhizhi and other drugs to enhance the effect of regulating the nervous system of the brain, and helps to improve the symptoms such as low mood, insomnia, and slow thinking that are common in patients with depression. During the preparation process, Baoziren is treated with water extraction together with Chaihu and Xiangfu and other liver-soothing and qi-regulating drugs, and its effective components cooperate with other drug components to not only assist and strengthen the soothing nerves effect, but also balance the dryness of qi-regulating drugs, thereby providing support for the synergistic effect of the whole formula of "soothing the nerves without stagnation of qi, regulating qi without damaging yin", so as to help improve the treatment effect on depression.

[0091] In summary, the drug of the present application realizes the synergistic effect of multiple components through scientific formula design, and is verified by tests to be able to definitely improve the symptoms of depression with small side effects, and is a traditional Chinese medicine drug for treating depression with definite curative effect, small side effects and scientific formula.

[0092] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A drug for treating depression, characterized in that, It is made from the following components by weight: Bupleurum chinense 8-12 parts, Cyperus rotundus 4-6 parts, Citrus reticulata peel 8-10 parts, Scutellaria baicalensis 8-12 parts, Curcuma longa 8-12 parts, Alpinia oxyphylla 8-12 parts, Polygala tenuifolia 8-12 parts, Melia toosendan 8-10 parts, Anemarrhena asphodeloides 8-12 parts, Coptis chinensis 7-9 parts, Gardenia jasminoides 8-12 parts, Ziziphus jujuba var. spinosa 12-18 parts, Agrimonia pilosa 8-12 parts, Acanthopanax senticosus 7-9 parts, Citrus aurantium 8-12 parts, Glycyrrhiza uralensis 5-7 parts, Rehmannia glutinosa 12-18 parts, Magnolia officinalis 8-12 parts, and Platycladus orientalis 8-12 parts.

2. The medicament for treating depression according to claim 1, characterized in that, It is made from the following components by weight: Bupleurum chinense 10 parts, Cyperus rotundus 5 parts, Citrus reticulata peel 9 parts, Scutellaria baicalensis 10 parts, Curcuma longa 10 parts, Alpinia oxyphylla 10 parts, Polygala tenuifolia 10 parts, Melia toosendan 9 parts, Anemarrhena asphodeloides 10 parts, Coptis chinensis 8 parts, Gardenia jasminoides 10 parts, Ziziphus jujuba var. spinosa 15 parts, Agrimonia pilosa 10 parts, Acanthopanax senticosus 8 parts, Citrus aurantium 10 parts, Glycyrrhiza uralensis 6 parts, Rehmannia glutinosa 15 parts, Magnolia officinalis 10 parts, and Platycladus orientalis 10 parts.

3. A method for preparing a drug for treating depression, characterized in that, Includes the following steps: S1. Weigh each Chinese herbal medicine component according to the weight proportions described in claim 1 or 2, pulverize them separately, and pass them through an 80-120 mesh sieve to obtain each Chinese herbal medicine powder; S2. Mix Bupleurum, Cyperus, Tangerine Peel, Scutellaria, Curcuma, Melia toosendan, Anemarrhena, Coptis, Gardenia, Bitter Orange Peel, Magnolia officinalis, and Platycladus orientalis seeds. Add 8-10 times the amount of water, soak for 30-60 minutes, heat to boiling, and simmer for 1.5-2 hours. Filter to obtain the first filtrate and the dregs. S3. Add 6-8 times the amount of water to the above-mentioned dregs, heat to boiling, maintain a gentle boil and simmer for 1-1.5 hours, filter to obtain the second filtrate. S4. Combine the first and second filtrates and concentrate under reduced pressure to a clear extract with a relative density of 1.10-1.15; S5. Mix Alpinia oxyphylla, Polygala tenuifolia, Ziziphus jujuba var. spinosa, Agrimonia pilosa, Acanthopanax senticosus, Glycyrrhiza uralensis, and Rehmannia glutinosa. Add 6-8 times the amount of 70%-80% ethanol, soak for 30-60 minutes, then heat and reflux for 1-1.5 hours. Filter to obtain the first ethanol extract and the residue. S6. Add 4-6 times the amount of 70%-80% ethanol to the above-mentioned residue, heat and reflux for 0.5-1 h, filter, and obtain the second ethanol extract. S7. Combine the first and second alcohol extracts, recover the ethanol under reduced pressure, and concentrate to a clear extract with a relative density of 1.10-1.

15. S8. Mix the water extract obtained in step S4 and the alcohol extract obtained in step S7 evenly to obtain the drug.

4. The preparation method according to claim 3, characterized in that, In step S1, the mesh size of the sieve is 100 mesh.

5. The preparation method according to claim 3, characterized in that, In step S2, add 9 times the amount of water, soak for 45 minutes, and simmer at a gentle boil for 1.8 hours.

6. The preparation method according to claim 3, characterized in that, In step S3, add 7 times the amount of water and simmer for 1.2 hours at a gentle boil.

7. The preparation method according to claim 3, characterized in that, In step S5, add 7 times the amount of 75% ethanol, soak for 45 minutes, and heat under reflux for 1.2 hours.

8. The preparation method according to claim 3, characterized in that, In step S6, add 5 times the amount of 75% ethanol and heat under reflux for 0.8 h.

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