Traditional Chinese medicine preparation for treating or improving depression

Abstract

The invention provides a traditional Chinese medicine preparation for treating or improving depression, and relates to the technical field of traditional Chinese medicine pharmacy. The traditional Chinese medicine preparation is prepared from the following ten medicinal materials: semen aesculi, fructus citri, fructus toosendan, semen celosiae, herba commelinae, herba senecionis scandentis, fructus liquidambaris, semen pruni, common fenugreek seed and liquorice root, and all the medicinal materials are combined to achieve the effects of soothing liver and regulating qi, clearing liver and purging fire, regulating liver and spleen simultaneously, dredging meridians and collaterals and warming kidney yang, so that liver depression can be relieved, qi activity can be smooth, liver fire can be cleared and depression syndrome can be removed. The traditional Chinese medicine preparation disclosed by the invention has a remarkable improvement effect on depression-like behaviors of mice with depression and has a remarkable inhibition effect on neuroinflammation. Meanwhile, the traditional Chinese medicine preparation is combined with western medicines to treat depression, the effect is remarkable, the HAMD-17, HAMA and TESS scores of treated depression patients can be remarkably reduced, depression and anxiety moods of the patients are remarkably improved, adverse reactions are relieved, and the traditional Chinese medicine preparation provides a new thought for treating depression through traditional Chinese medicine.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical preparation, and in particular to a traditional Chinese medicine preparation for treating or improving depression. Background Art

[0002] Depression is a common mental disorder that endangers human physical and mental health. Its main clinical manifestations are low mood, slow thinking and behavior, slow reaction, loss of interest, pessimism and despair, etc. It has the characteristics of high prevalence, high recurrence rate, and high disability rate. According to statistics from the World Health Organization, 3% to 5% of the world's population suffers from the disease, with a prevalence rate of 4.4%, while the prevalence rate in my country is 4.2%, which has become a serious public social problem. At present, Western medicine mainly uses antidepressant chemical drugs such as fluoxetine, paroxetine, escitalopram, etc. to treat depression. Although Western medicine has a certain antidepressant effect, it still has problems such as slow onset, obvious side effects, strong dependence, and even some depression resistance.

[0003] In traditional Chinese medicine, "depression" is classified as "depression disease", which is an emotional disease in traditional Chinese medicine. The meaning of depression disease can be divided into broad and narrow meanings. In a broad sense, it refers to the body's poor qi movement, the six external evil spirits, and the stagnation of emotions, including five-movement depression, viscera depression, and six depressions; in a narrow sense, depression syndrome is mostly caused by emotional frustration or poor qi movement, which leads to long-term stagnation, such as visceral agitation and plum pit qi, with depression, grievance and easy crying, and insomnia as the main clinical manifestations, and can also be accompanied by physical symptoms, such as chest and flank fullness and discomfort, throat as if there is something stuck, etc. The disease is mainly located in the liver, and is closely related to the heart and spleen. At present, most of the traditional Chinese medicines used in the clinic for the treatment of depression start with "soothing the liver" and achieve "resolving depression" through "soothing the liver", and are mostly used as auxiliary medicines for the treatment of depression. Traditional Chinese medicine and its traditional Chinese medicine compound have achieved significant therapeutic effects in the treatment of depression due to their characteristics of multi-pathway, multi-component, multi-target synergy, and small side effects, such as Jieyu Pills, Danzhi Xiaoyao Powder, Shugan Jieyu Capsules and other Chinese patent medicines. The present invention aims to provide a safe, effective, and excellently effective traditional Chinese medicine preparation for the treatment or improvement of depression. Summary of the invention

[0004] 1. Technical issues to be solved

[0005] In view of the deficiencies of the prior art, the present invention provides a safe, effective and excellent Chinese medicine preparation for treating or improving depression.

[0006] (II) Technical solution

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] The invention provides a traditional Chinese medicine preparation for treating or improving depression. The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 5-25 parts of sago seeds, 5-25 parts of citron, 5-25 parts of toosendan seeds, 1-20 parts of liquidambar formosana, 1-20 parts of Prunus mume seeds, 5-25 parts of communis, 1-20 parts of senecio, 5-25 parts of amaranthus, 1-20 parts of fenugreek, and 1-10 parts of liquorice.

[0009] Furthermore, the Chinese medicine preparation is made of the following raw materials in parts by weight: 10-20 parts of sago seeds, 10-20 parts of citron, 10-20 parts of toosendan seeds, 5-15 parts of rhizoma liquidambar formosana, 5-15 parts of prunus mume seeds, 10-20 parts of communis, 5-15 parts of semen scabra, 10-20 parts of amaranthus seeds, 5-15 parts of fenugreek, and 5-10 parts of licorice.

[0010] Furthermore, the Chinese medicine preparation is made of the following raw materials in parts by weight: 12 parts of sarophore seeds, 12 parts of citron, 12 parts of toosendan seeds, 10 parts of rhizoma liquidambar formosana, 12 parts of prunus mume seeds, 15 parts of communis, 10 parts of semen serrata, 12 parts of amaranthus seeds, 10 parts of fenugreek, and 6 parts of liquorice.

[0011] The Chinese medicine preparation provided by the present invention is used to prepare a drug for treating or improving depression. The Chinese medicine preparation is prepared into granules, powders, oral liquids, pills, decoctions, lyophilized powders or other pharmaceutically acceptable oral dosage forms according to conventional pharmaceutical preparation methods in pharmacy and with medically acceptable adjuvants.

[0012] Sauerkraut seeds: warm in nature, sweet in taste, and enter the liver and stomach meridians; it has the effects of relieving fullness, regulating qi, harmonizing the stomach, and relieving pain; it mainly contains triterpenoid saponins, flavonoids, coumarins, indole alkaloids, fatty oils and other ingredients; modern pharmacological research shows that Sauerkraut seeds have multiple pharmacological activities such as anti-inflammatory, antioxidant, anti-tumor, and neuroprotection.

[0013] Citron: It tastes pungent, bitter, and sour, and is warm in nature. It enters the liver, spleen, and lung meridians. It has the effects of soothing the liver and regulating qi, relieving fullness, and resolving phlegm. It is used for liver and stomach qi stagnation, chest and flank pain, abdominal distension, vomiting and belching, cough with sputum, etc. Citron contains a variety of active chemical substances such as volatile oils, flavonoids, coumarins, alkaloids, etc., which have various pharmacological effects such as antioxidant, antibacterial, anti-diabetic, and lipid-lowering.

[0014] Toosendan fruit: bitter and cold in nature, slightly toxic, enters the liver, small intestine and bladder meridians; has the effects of soothing the liver and relieving heat, promoting qi and relieving pain, and killing insects; mainly contains volatile oils, lignans, organic acids, flavonoids, limonoids and other ingredients; modern pharmacological studies have shown that Toosendan fruit has anti-inflammatory, analgesic, neuroprotective effects on the central nervous system, as well as antioxidant, insecticidal, antibacterial, antiviral, and anti-tumor effects.

[0015] Lulutong: bitter, neutral; enters the liver and kidney meridians; has the effects of dispelling wind and dampness, soothing the liver and activating collaterals, promoting diuresis and dredges the menstruation, etc., and is used for symptoms such as water swelling, less milk, and amenorrhea. Lulutong mainly includes betulinic acid, gallic acid, lulutong ketone A and other terpenes, aliphatic, aromatic and other ingredients; has anti-inflammatory, neuroprotective, antioxidant, anti-tumor and other pharmacological effects.

[0016] Prunus mume seeds: pungent, bitter, sweet, neutral. Enters the spleen, large intestine, and small intestine meridians. Moisturizes and lubricates the intestines, relieves qi, and promotes diuresis. Used for dry intestines due to lack of body fluid, food accumulation and qi stagnation, abdominal distension and constipation, edema, beriberi, and difficulty urinating. It has the effects of moisturizing and lubricates the intestines, relieves qi and relieves stagnation, and promotes diuresis and reduces swelling; it mainly contains flavonoids, fatty acids, amino acids, glycosides, and mineral elements; it has multiple pharmacological effects such as moisturizing and lubricates the intestines, anti-inflammatory, analgesic, antioxidant, anti-aging, and anti-tumor.

[0017] Commelina: sweet, light in taste, cold in nature, enters the lung, stomach, and small intestine meridians, has the effects of clearing away heat and purging fire, detoxifying, promoting diuresis and reducing swelling, and is used for colds and fever, fever and thirst, delayed swelling and pain, edema and oliguria, hot stranguria and painful stranguria, etc.; its main active ingredients are flavonoids and alkaloids, and it has multiple pharmacological effects such as antioxidant, antihypertensive, lipid metabolism regulation, anti-inflammatory and analgesic, antiviral, and antibacterial.

[0018] Senecio: bitter in taste, cold in nature, enters the lung and liver meridians; has the effects of clearing away heat and detoxifying, improving eyesight, promoting dampness, killing insects and relieving pain; used for carbuncle, fever and cold, red and swollen eyes, diarrhea, dysentery, skin eczema and other diseases; mainly contains senecioine, seneciophylline, lupenone, oleanane, β-sitosterol, carotene, alkaloids, p-hydroxyphenylacetic acid, hyperoside, montmorillonol, oleanol, quercetin, racemic syringaresinol, rhubarb, chlorogenic acid, caffeic acid and other ingredients, has a strong antibacterial effect on Staphylococcus aureus, Salmonella typhi, Salmonella paratyphi A, Salmonella paratyphi B, Shigella dysenteriae, Shigella boydii and Shigella sonnei.

[0019] Celosia chinensis: bitter, slightly cold. Enters the liver meridian. Clears the liver, improves eyesight, and removes cataracts. Used for liver heat, red eyes, cataracts, blurred vision, and liver fire dizziness. Modern pharmacological studies have shown that Celosia chinensis has multiple effects such as liver protection, anti-cataract, anti-tumor, immunomodulatory, anti-diabetic, and antibacterial.

[0020] Fenugreek: warm in nature, bitter in taste; has the effects of warming the kidney, dispelling cold and relieving pain; used for symptoms such as kidney deficiency and cold, cold pain in the lower abdomen, small intestinal hernia, cold and damp athlete's foot, etc.; it mainly contains steroidal saponins, flavonoids, terpenes, alkaloids, fats and oils, amino acids and proteins and other active ingredients; modern pharmacological research shows that fenugreek has multiple effects such as lowering blood sugar, lowering blood lipids, anti-oxidation, anti-tumor, analgesia and anti-inflammatory.

[0021] Licorice: sweet in taste, neutral in nature, enters the heart, spleen, lung, and stomach meridians; has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving acute pain, and harmonizing various medicines; used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, carbuncles, sores and other symptoms. Licorice is also good at harmonizing the properties of medicines and alleviating the toxicity of drugs.

[0022] (III) Beneficial effects

[0023] The Chinese medicine preparation of the present invention is made of ten medicinal materials in total, namely, sago seed, citron, toosendan seed, amaranth seed, communis herb, senecio radix, fennel seed, fenugreek and liquorice. In the prescription, sago seed can soothe the liver and regulate qi, harmonize the stomach and relieve pain, citron can dry out dampness and resolve phlegm, enter the spleen and stomach to promote qi and relieve fullness, and the two medicines can be used together to soothe the liver and relieve depression to relieve stagnation, regulate qi, relieve fullness and harmonize the spleen and stomach, and are the main medicines; toosendan seed can soothe the liver and purge heat, promote qi and relieve pain, amaranth seed can clear the liver and purge fire, communis herb can clear dampness and heat, and senecio radix can clear heat and detoxify, improve eyesight and relieve dampness, and the four can be used together to promote each other, can clear liver fire, promote qi stagnation, and have the effects of clearing heat and purging fire, calming liver yang, and relieving dryness and restlessness. The four herbs are used as adjuvants. The combination of the above herbs can relieve liver qi, clear liver fire, regulate liver and spleen, dredge meridians, and warm kidney yang, so that liver depression can be relieved, qi can be smooth, liver fire can be cleared, and depression syndrome can be eliminated.

[0024] The Chinese medicine preparation of the present invention has a significant improvement effect on the depressive-like behavior of depression mice; it can significantly reduce the content of pro-inflammatory factors in the hippocampus of depression mice, significantly increase the content of anti-inflammatory factors in the hippocampus of depression mice, and can also significantly inhibit the pro-inflammatory M1 polarization of microglia in the DG brain region of the hippocampus of depression mice, and has a significant inhibitory effect on neuroinflammation. At the same time, the Chinese medicine preparation of the present invention is significantly effective in treating depression in combination with Western medicine, can significantly improve the total effective rate of treating depression, can significantly reduce the HAMD-17, HAMA and TESS scores of depression patients after treatment, significantly improve the depression and anxiety of patients, and reduce adverse reactions. The Chinese medicine preparation of the present invention provides a new idea for the treatment of depression with traditional Chinese medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 These are the results of fluorescence detection of pro-inflammatory M1 polarized microglia in the DG region of the hippocampus of mice in each group. The white arrows indicate M1 polarized cells.

[0026] Figure 2 Comparison of HAMD-17 scores between the two groups before and after treatment; compared with the same group before treatment, **P<0.01; compared with the control group, ## P<0.01.

[0027] Figure 3Comparison of HAMA scores between the two groups of patients before and after treatment; compared with the same group before treatment, **P<0.01; compared with the control group, ## P<0.01.

[0028] Figure 4 Comparison of TESS scores between the two groups of patients after 8 weeks of treatment; compared with the control group, *P<0.05. DETAILED DESCRIPTION

[0029] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0030] Example 1

[0031] A traditional Chinese medicine preparation for treating or improving depression, the traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 8 parts of sarophore seeds, 8 parts of citron, 8 parts of toosendan seeds, 4 parts of liquidambar formosana, 8 parts of Prunus mume seeds, 8 parts of communis, 8 parts of senecio, 8 parts of amaranthus, 8 parts of cyperus rotundus, 4 parts of fenugreek, and 2 parts of liquorice.

[0032] The Chinese medicine preparation provided by the present invention is used to prepare a drug for treating or improving depression. The Chinese medicine preparation is prepared into granules, powders, oral liquids, pills, decoctions, lyophilized powders or other pharmaceutically acceptable oral dosage forms according to conventional pharmaceutical preparation methods in pharmacy and with medically acceptable adjuvants.

[0033] Example 2

[0034] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following raw materials in parts by weight: 24 parts of sarophore seeds, 22 parts of citron, 22 parts of toosendan seeds, 18 parts of rhizoma liquidambar formosana, 16 parts of Prunus mume seeds, 22 parts of Commelina communis, 16 parts of Senecio grandiflora, 22 parts of Amaranthus acutus seeds, 16 parts of fenugreek, and 8 parts of liquorice.

[0035] Example 3

[0036] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following raw materials in parts by weight: 16 parts of sarophore seeds, 14 parts of citron, 14 parts of toosendan seeds, 12 parts of rhizoma liquidambar formosana, 16 parts of Prunus mume seeds, 18 parts of Commelina communis, 16 parts of Senecio grandiflora, 14 parts of Amaranthus acutus seeds, 16 parts of fenugreek, and 7 parts of liquorice.

[0037] Example 4

[0038] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following raw materials in parts by weight: 10 parts of sarophore seeds, 10 parts of citron, 10 parts of toosendan seeds, 5 parts of rhizoma liquidambar formosana, 5 parts of Prunus mume seeds, 10 parts of communis, 5 parts of semen serrata, 10 parts of amaranthus seeds, 5 parts of fenugreek, and 5 parts of liquorice.

[0039] Example 5

[0040] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following raw materials in parts by weight: 20 parts of sarophore seeds, 20 parts of citron, 20 parts of toosendan seeds, 15 parts of rhizoma liquidambar formosana, 15 parts of prunus mume seeds, 20 parts of communis, 15 parts of semen serrata, 20 parts of amaranthus seeds, 15 parts of fenugreek, and 10 parts of liquorice.

[0041] Example 6

[0042] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following raw materials in parts by weight: 16 parts of sarophore seeds, 16 parts of citron, 14 parts of toosendan seeds, 10 parts of rhizoma liquidambar formosana, 12 parts of Prunus mume seeds, 14 parts of Commelina communis, 12 parts of Senecio grandiflora, 16 parts of Amaranthus acutus seeds, 8 parts of fenugreek, and 8 parts of liquorice.

[0043] Example 7

[0044] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following raw materials in parts by weight: 12 parts of sarophore seeds, 12 parts of citron, 12 parts of toosendan seeds, 10 parts of rhizoma liquidambar formosana, 12 parts of Prunus mume seeds, 15 parts of communis, 10 parts of semen serrata, 12 parts of amaranthus seeds, 10 parts of fenugreek, and 6 parts of liquorice.

[0045] Test Example 1

[0046] 1 Materials and methods

[0047] 1.1 Preparation of experimental animals and depression mouse model

[0048] 60 SPF male ICR mice, weighing 20±2 g, were provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd.

[0049] The mice were adaptively fed for 1 week and randomly divided into a normal group (10 mice) and a model group (50 mice). The model group was housed in a single cage and given random chronic unpredictable mild stimulation to establish a depression model. The main methods of chronic unpredictable mild stimulation were: inclined cage (45°), wet cage (24h), strobe (300flash / min), noise (70dB), water deprivation (12h), all-night lighting (12h), restraint (4h), day and night reversal (24h), paired feeding (12h), empty bottle stimulation (1h), ice water swimming (4℃, 5min). 3-4 kinds of stimulation were randomly given every day for 6 consecutive weeks, and the stimulation order was randomly adjusted.

[0050] 1.2 Trial Drugs

[0051] The Chinese medicine preparation of the present invention is as follows: weigh the following raw materials according to the following weight proportions: 12 parts of sarophora seeds, 12 parts of citron, 12 parts of toosendan seeds, 10 parts of fennel seeds, 12 parts of rhizoma lycopersicum, 15 parts of coleus, 10 parts of semen serrata, 12 parts of amaranthus seeds, 10 parts of fenugreek seeds, 6 parts of liquorice, wash, soak in 3 times of deionized water for 30 minutes, then decoct for 40 minutes, repeat the decoction for more than 2 times, collect the decoction, concentrate the decoction to 1g / mL (1mL contains 1g of crude drug), store at 4°C for standby use.

[0052] Western medicine comparison: paroxetine

[0053] Chinese medicine comparison: Danzhi Xiaoyao Powder

[0054] 1.3 Experimental Grouping and Treatment

[0055] After 6 weeks of chronic unpredictable mild stimulation, the 50 mice with successful modeling were randomly divided into 5 groups, namely, model group, western medicine positive control group (paroxetine, 20 mg / kg), Chinese medicine positive control group (Danzhi Xiaoyaosan, 7 g / kg), high-dose group of Chinese medicine preparation of the present invention (8.6 g / kg, referred to as high-dose group), and low-dose group of Chinese medicine preparation of the present invention (4.3 g / kg, referred to as low-dose group); 10 mice in each group were continuously gavaged for 4 weeks, and chronic mild stimulation was continued during the administration period. 10 healthy mice were the blank control group, and the same dose of normal saline was gavaged. After the last administration of each group of mice, the depressive-like behavior of each group of mice was evaluated by sugar water preference, forced swimming, tail suspension test and open field test. After the behavioral test, the mice were killed, serum was collected, and the brain hippocampus tissue was separated on ice and stored in a refrigerator at -80°C for subsequent experiments.

[0056] 1.4 Detection indicators

[0057] 1.4.1 Sugar Preference Test (SPT)

[0058] After the last drug administration, mice were deprived of water and food for 24 hours, and then given 1% sugar water and tap water weighed in advance. After 6 hours, the water bottles were swapped. After 12 hours, the water bottles were collected and weighed, and the intake of sugar water and tap water was calculated. Sugar water preference was defined as the sugar water intake divided by the sum of sugar water and tap water intake.

[0059] 1.4.2 Behavioral testing

[0060] 1.4.2.1 Forced swim test (FST)

[0061] The mice need to adapt to the test behavior environment for 2 hours in advance. The mice are placed in a 5L glass container with a transparent cup body, a diameter of 18cm, a height of 26.5cm, a water depth of about 15cm, and a water temperature of 25℃. The mice after drug administration are gently placed in the water. The activity of the mice within 6 minutes is recorded by video, and the activity of the mice in the last 4 minutes is selected to calculate the continuous swimming time and immobility time.

[0062] 1.4.2.2 Tail suspension test (TST)

[0063] Place the mouse gently in the palm of your hand and let it calm down for 5 minutes. Then use tape to gently fix the mouse's tail to the top of the experimental frame. Record the mouse's struggle within 6 minutes with a video. Select the time in the last 4 minutes when the mouse's limbs and trunk are completely motionless.

[0064] 1.4.2.3 Open Field Test (OFT)

[0065] The activity status of the animals was evaluated by observing their voluntary activities, and the number of activities, number of standing times, center activity distance, center stay time, and total activity distance were recorded and analyzed.

[0066] 1.4.3 Detection of inflammatory factors in hippocampal tissue

[0067] Elisa kits were used to detect the expression changes of pro-inflammatory factors (TNF-α, IL-1β) and anti-inflammatory factors (IL4, IL10) in hippocampal tissue protein homogenate.

[0068] 1.4.4 Detection of microglial inflammatory polarization

[0069] The hippocampal tissue paraffin sections were immunofluorescently stained with antibodies to microglial M1 polarization marker proteins (Iba-1, CD68), and photographed under a laser confocal microscope.

[0070] 1.5 Statistical analysis

[0071] SPSS 21.0 was used for statistical analysis, and one-way analysis of variance was used for inter-group comparisons. The results are expressed as mean ± standard deviation The data were analyzed using t-test. P < 0.05 was considered statistically significant.

[0072] 2 Results

[0073] 2.1 Effect of the Chinese medicine preparation of the present invention on the depressive-like behavior of the depression mouse model

[0074] The results are shown in Table 1. Compared with the blank control group, the sugar water preference rate of the model group mice was significantly reduced (P<0.05), the immobility time of the forced swimming and tail suspension tests was significantly increased (P<0.01), the total movement distance in the open field test remained unchanged, but the central movement distance of the open field was significantly shortened (P<0.01), indicating that the model was successfully established. Compared with the model group, the depressive-like behavior of the mice in each drug-treated group was significantly improved, among which the western medicine positive control group, high and low dose groups and low dose group significantly increased the sugar water preference rate (P<0.05); compared with the model group, the Chinese medicine positive control group, the western medicine positive control group, the low dose group and the high dose group significantly reduced the forced swimming and tail suspension immobility time of the depressed mice (P<0.05 or P<0.01), and increased the central movement distance of the open field (P<0.05 or P<0.01). The above results show that the Chinese medicine preparation of the present invention can significantly improve the depressive-like behavior of depression mice. The behavioral experimental results suggest that the Chinese medicine composition of the present invention has the effect of significantly improving depressive-like behavior, and the effect is better than the Chinese medicine Danzhi Xiaoyao Powder and equivalent to the Western medicine paroxetine.

[0075] Table 1 Results of sugar water preference and depressive-like behavior test in each group of mice

[0076]

[0077] Note: Compared with the blank control group, #: P<0.05, ##: P<0.01; compared with the model group, *: P<0.05, **: P<0.05; the same below.

[0078] 2.2 Effects of the Chinese medicine preparation of the present invention on inflammatory factors in the hippocampus of a mouse model of depression

[0079] As shown in Table 2, compared with the blank control group, the pro-inflammatory cytokines (TNF-α, IL-1β) of the model group mice were significantly increased (P<0.01, P<0.01), and the anti-inflammatory cytokines (IL-4, IL-10) were significantly reduced (P<0.01, P<0.01). Compared with the model group, the Chinese medicine positive control group, the Western medicine positive control group, the high and low dose groups all significantly reduced pro-inflammatory cytokines (TNF-α, IL-1β) (P<0.05 or P<0.01), and significantly increased anti-inflammatory cytokines (IL-4, IL-10) (P<0.05 or P<0.01). This result shows that the Chinese medicine preparation of the present invention has a specific and significant inhibitory effect on hippocampal neuroinflammation.

[0080] Table 2 Contents of anti-inflammatory and pro-inflammatory cytokines in the hippocampal tissue of mice in each group

[0081]

[0082] 2.3 Effect of the Chinese medicine preparation of the present invention on the pro-inflammatory M1 polarization of hippocampal microglia in a mouse model of depression

[0083] Neuroinflammatory disorders mediated by proinflammatory M1 polarization of hippocampal microglia are important pathogenic factors for depression. Figure 1 As shown in the figure, compared with the blank control group, the pro-inflammatory M1 polarization of microglia in the DG region of the hippocampus of the model group mice (Iba + +CD68) was significantly increased; compared with the model group, the Chinese medicine positive control group, the Western medicine positive control group, the high-dose group and the low-dose group all significantly reduced the pro-inflammatory M1 polarization of microglia in the hippocampal DG brain region.

[0084] 3 Conclusion

[0085] The above results show that the Chinese medicine preparation of the present invention has a significant improvement effect on the depressive-like behavior of mice with depression; the Chinese medicine preparation of the present invention can significantly reduce the content of pro-inflammatory factors in the hippocampus of mice with depression, and significantly increase the content of anti-inflammatory factors in the hippocampus of mice with depression. At the same time, it can also significantly inhibit the pro-inflammatory M1 polarization of microglia in the DG brain region of the hippocampus of depressed mice. The Chinese medicine preparation of the present invention has a significant inhibitory effect on neuroinflammation. The Chinese medicine preparation of the present invention has a significant therapeutic effect on mice with depression, which is equivalent to the effect of the Western medicine paroxetine, and is better than the Chinese medicine Danzhi Xiaoyaosan.

[0086] Test Example 2

[0087] 1 Materials and methods

[0088] 1.1 General Information

[0089] A total of 78 patients with depression admitted to Pingyu County Hospital of Traditional Chinese Medicine from March 2023 to September 2024 were selected and divided into a control group and an observation group by random number table method, with 39 cases in each group. There were 19 males and 20 females in the control group, with a course of 1-6 years, an average of (3.09±1.58) years; an age of 18 to 55 years, an average of (35.18±6.81) years. There were 22 males and 17 females in the observation group; a course of 2-8 years, an average of (4.87±2.06) years; an age of 18 to 60 years, an average of (38.17±5.91) years. There was no significant difference in general data such as gender, course of disease, and age between the two groups (P>0.05), and they were comparable.

[0090] Inclusion criteria: ① meet the diagnostic criteria for depression in the International Classification of Diseases 10 (ICD-10); ② Hamilton Depression Scale-17 Items (HAMD-17) score ≥ 17 points; ③ age 18 to 60 years old; ④ no personality disorder and good social adaptation function.

[0091] Exclusion criteria: ① There is a serious tendency to harm oneself; ② Allergy or intolerance to the study drug; ③ Received systematic antidepressant treatment in the past 2 months, and the current depression-related symptoms have been basically relieved; ④ Combined with malignant tumors; ⑤ There are serious organic diseases such as heart, lung, liver, and kidney; ⑥ Pregnant or lactating women; ⑦ Hallucinations, delusions, or any psychotic symptoms during this depressive episode; ⑧ Participated in a clinical trial in the past 90 days, or participated in 2 or more clinical trials in the past year.

[0092] 1.2 Methods

[0093] The control group was given oral sertraline hydrochloride tablets, 50 mg / time, once / d.

[0094] On the basis of the treatment of the control group, the observation group was given the Chinese medicine decoction of the present invention, which specifically consisted of 12g of Sauerkraut seeds, 12g of Citron, 12g of Toosendan seeds, 10g of Fructus Lycoris, 12g of Semen Pruni, 15g of Commelina, 10g of Senecio, 12g of Coptidis seeds, 10g of Fenugreek, and 6g of Licorice, decocted in water, one dose per day, taken twice, once in the morning and once in the evening.

[0095] Both groups were treated for 8 weeks.

[0096] 1.3 Observation indicators and efficacy evaluation criteria

[0097] (1) Psychological state: HAMD-17 and Hamilton Anxiety Scale (HAMA) were used to evaluate the psychological state of the two groups of patients before and after treatment.

[0098] (2) Clinical efficacy: The clinical efficacy was evaluated with reference to the HAMD-17 score reduction rate: cure means that depressive symptoms disappear and the mood is normal, with a score reduction rate ≥ 75%; marked effect means that depressive symptoms basically disappear and the mood is basically normal, with a score reduction rate ≥ 50%; effective means that depressive symptoms are alleviated and the mood is relatively stable, with a score reduction rate ≥ 25%; ineffective means that depressive symptoms are not alleviated and the mood is not improved, with a score reduction rate < 25%.

[0099] (3) Adverse reactions: After 8 weeks of treatment, the Treatment Emergent Symptom Scale (TESS) was used to evaluate the adverse reactions of the two groups of patients, including insomnia, drowsiness, nausea and vomiting, anorexia, dry mouth, and constipation. The severity was divided into 0 to 4 points, with 0 point for no symptom; 1 point for occasional symptom; 2 point for mild, no effect on normal function; 3 point for moderate, affecting normal function; 4 point for severe, significantly impairing normal function.

[0100] 1.4 Statistical analysis

[0101] SPSS 21.0 statistical software was used to express measurement data as mean ± standard deviation, non-independent sample t test was used between groups, paired sample t test was used within groups, count data were expressed as percentages, and inter-group comparisons were performed using the χ 2 Test, P < 0.05 was considered statistically significant.

[0102] 2 Results

[0103] 2.1 Comparison of HAMD-17 and HAMA scores between the two groups before and after treatment

[0104] The results are as follows Figure 2 , Figure 3 As shown in the results, compared with those before treatment, the HAMD-17 and HAMA scores of the two groups of patients after treatment were significantly reduced (P < 0.01); after treatment, the HAMD-17 and HAMA scores of the observation group were significantly lower than those of the control group (P < 0.01).

[0105] 2.2 Comparison of clinical efficacy between the two groups of patients

[0106] The results are shown in Table 3. The total effective rate of the observation group was 94.87%, significantly higher than the total effective rate of the control group (76.92%).

[0107] Table 3 Comparison of clinical efficacy between the two groups of patients (n / %)

[0108] Grouping quantity get well Significant effect efficient invalid Total Effectiveness Observation Group 39 4(10.25) 21(53.84) 12(30.76) 2(5.13) 94.87％ Control group 39 2(5.13) 15(38.46) 13(33.33) 9(23.07) 76.92％

[0109] 2.3 Comparison of TESS scores between the two groups after 8 weeks of treatment

[0110] The results are as follows Figure 4 As shown in the data, the scores of insomnia, sleepiness, nausea and vomiting, dry mouth and constipation in the observation group were significantly lower than those in the control group, among which the scores of insomnia, sleepiness and nausea and vomiting in the observation group were significantly lower than those in the control group (P < 0.05).

[0111] 3 Conclusion

[0112] The preparation of the present invention combined with Western medicine has a significant effect in treating depression, can significantly improve the total effective rate of treating depression, can significantly reduce the HAMD-17, HAMA and TESS scores of patients with depression after treatment, significantly improve the depression and anxiety of patients, and reduce adverse reactions. The Chinese medicine preparation of the present invention provides a new idea for the treatment of depression with traditional Chinese medicine.

[0113] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine preparation for treating or improving depression, characterized in that: The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 5-25 parts of sarophora seeds, 5-25 parts of citron, 5-25 parts of toosendan seeds, 1-20 parts of rhizoma liquidambar formosana, 1-20 parts of prunus mume seeds, 5-25 parts of communis, 1-20 parts of senecio, 5-25 parts of amaranthus seeds, 1-20 parts of fenugreek, and 1-10 parts of liquorice.

2. A Chinese medicine preparation for treating or improving depression according to claim 1, characterized in that: The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 10-20 parts of sarophora seeds, 10-20 parts of citron, 10-20 parts of toosendan seeds, 5-15 parts of rhizoma liquidambar formosana, 5-15 parts of prunus mume seeds, 10-20 parts of communis, 5-15 parts of semen scabra, 10-20 parts of amaranthus seeds, 5-15 parts of fenugreek, and 5-10 parts of liquorice.

3. A Chinese medicine preparation for treating or improving depression according to claim 1, characterized in that: The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 12 parts of sarophora seeds, 12 parts of citron, 12 parts of toosendan seeds, 10 parts of rhizoma liquidambar formosana, 12 parts of prunus mume seeds, 15 parts of communis, 10 parts of semen serrata, 12 parts of amaranthus seeds, 10 parts of fenugreek seeds and 6 parts of liquorice.

4. Use of the Chinese medicine preparation according to any one of claims 1 to 3 in the preparation of a drug for treating or improving depression, characterized in that: The Chinese medicine preparation is prepared into granules, powders, oral liquids, pills, decoctions, lyophilized powders or other pharmaceutically acceptable oral dosage forms by conventional pharmaceutical preparation methods and with medically acceptable adjuvants.

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