Traditional Chinese medicine composition for preventing and treating depression and preparation method thereof

Through the combination of drugs such as Bupleurum, Baishao and other drugs and water decoction and decompression concentration technology, a Chinese medicine composition with significant effects on prevention and treatment of depression was prepared, which solved the drug resistance and adverse reactions of Western medicine in the treatment of depression, and realized traditional Chinese medicine The systematic preparation of traditional Chinese medicine combined agents improves efficacy and safety.

CN119185489AInactive Publication Date: 2024-12-27SHANXI JIANSHUO FOOD & DRUG RES INST CO LTD
View PDF 6 Cites 0 Cited by

Patent Information

Application Number
CN202411484301.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-23
Publication Date
2024-12-27
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The current Western medicines have problems such as drug resistance, major adverse reactions, and recurrence due to stopping the drug. Traditional Chinese medicines have high safety, good efficacy, but lack systematic preparation methods for combination agents.

Method used

The traditional Chinese medicine composition consisting of medicines such as Bupleurum, White Peony, Xiangfu, Tulip, Sprigium, Morinica, Schisandra chinensis, Hehuan peel, Gardenia, Roasted Licorice, etc. is prepared by decocting water and concentrating under reduced pressure. It is made into an oral dosage form with the effects of relieving liver and regulating qi, strengthening spleen and kidneys, relieving depression and calming the mind.

Benefits of technology

It significantly improves the prevention and treatment effect of depression, reduces adverse reactions, enhances patient compliance, and realizes the systematic preparation of combined agents in traditional Chinese medicine, ensuring the stability and safety of drug efficacy.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure BDA0005098325100000071
    Figure BDA0005098325100000071
  • Figure BDA0005098325100000073
    Figure BDA0005098325100000073
  • Figure BDA0005098325100000082
    Figure BDA0005098325100000082
Patent Text Reader

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for preventing and treating depression and a preparation method thereof. The invention aims to give play to traditional Chinese medicine compatibility and use. The traditional Chinese medicine is composed of radix bupleuri, radix paeoniae alba, rhizoma cyperi, radix curcumae, radix acanthopanacis semticosi, radix morindae officinalis, schisandra chinensis, cortex albiziae, fructus gardeniae and honey-fried licorice root. The preparation method comprises the following steps: adding 8-12 times of water into the medicines in parts by weight, decocting, filtering, concentrating filtrate under reduced pressure, drying and crushing to obtain dry paste powder; and adding a proper amount of auxiliary materials into the prepared dry paste powder, uniformly mixing, and preparing into an oral dosage form by using a conventional process. The whole formula has the effects of soothing the liver, regulating qi, strengthening the spleen, tonifying the kidney, relieving depression and soothing the nerves; functional tests prove that the traditional Chinese medicine composition has an obvious effect of preventing and treating depression.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] The invention belongs to the technical field of medicine, and particularly relates to a Chinese medicine composition for preventing and treating depression and a preparation method thereof. Background Art

[0002] Depression is a common clinical emotional disorder, and patients are often characterized by low mood, loss of will and slow thinking. In clinical practice, Western medicine for depression has a relatively simple mechanism of action. Therefore, while exerting its limited efficacy, it also has the disadvantages of easy drug resistance, large adverse reactions, and easy relapse after discontinuation of medication. Traditional Chinese medicine for depression has the advantages of high safety, good efficacy, few adverse reactions, and high patient compliance.

[0003] Traditional Chinese medicine has a history of more than 2,000 years in the understanding and diagnosis of depression. Depression belongs to the category of "depression syndrome" in traditional Chinese medicine. It is a disease caused by qi stagnation and blood stasis, and organ dysfunction, with depression, restlessness, chest fullness, restlessness, rib pain, irritability, and foreign body sensation in the throat as the main manifestations. The records in Ye Tianshi's "Clinical Guide Medical Cases: Depression" are all about emotional depression, and the treatment involves soothing the liver and regulating qi, bitter and pungent herbs to promote descending, calming the liver and extinguishing wind, clearing the heart and purging fire, strengthening the spleen and stomach, promoting blood circulation and unblocking collaterals, resolving phlegm and eliminating fluid, and replenishing qi and nourishing yin. Depression is mainly located in the liver, and it is also easy to affect the heart, spleen, kidney and other organs. It can be seen that depression mainly treats the liver and spleen, and in treatment, drugs such as Bupleurum and White Peony Root are often used to soothe the liver and relieve depression, nourish blood and soften the liver.

[0004] At present, the Chinese patent medicines that can be used in synergistic antidepressant in clinic include Yueju Pills, Chaihu Shugan Powder, Jieyu Anshen Granules, Xiaoyao Pills, Morinda Officinalis Oligosaccharide Capsules, etc. Summary of the invention

[0005] The invention provides a traditional Chinese medicine composition for preventing and treating depression and a preparation method thereof.

[0006] Another object of the present invention is to provide a method for preparing the Chinese medicine composition.

[0007] The purpose of the present invention is to give full play to the compatibility of traditional Chinese medicine, which is composed of ten herbs: bupleurum, white peony root, cyperus rotundus, curcuma, acanthopanax senticosus, Morinda officinalis, schisandra chinensis, julibrissin bark, gardenia jasminoides, and licorice root; the whole formula can play the functions of soothing the liver and regulating qi, strengthening the spleen and tonifying the kidney, relieving depression and calming the mind; functional tests have confirmed that the present invention has obvious effects on the prevention and treatment of depression.

[0008] The technical solution adopted by the present invention is a Chinese medicine composition for preventing and treating depression and a preparation method thereof, which is made from the following medicinal ingredients in parts by weight:

[0009] 3-20 parts of bupleurum, 6-30 parts of white peony root, 5-20 parts of cyperus, 3-20 parts of curcuma, 10-30 parts of acanthopanax, 6-20 parts of morinda officinalis, 2-12 parts of schisandra, 6-20 parts of julibrissin bark, 6-15 parts of gardenia, and 3-9 parts of roasted liquorice.

[0010] The preparation method of the Chinese medicine composition for preventing and treating depression of the present invention comprises the following steps, calculated by weight:

[0011] The first step is to take 3-20 parts of bupleurum, 6-30 parts of white peony root, 5-20 parts of cyperus, 3-20 parts of curcuma, 10-30 parts of acanthopanax, 6-20 parts of Morinda officinalis, 2-12 parts of Schisandra chinensis, 6-20 parts of Albizzia julibrissin, 6-15 parts of Gardenia jasminoides, and 3-9 parts of licorice root in the above weight parts; add 8-12 times the amount of water to the above weight parts of the medicinal flavors, decoct 1-3 times, each time for 1-2 hours, filter through 200 mesh, and concentrate the filtrate under reduced pressure at a temperature of -0.06-0.08MPa and 60-70°C until it is concentrated to a thick paste with a relative density of 1.30; and measure the relative density value at 60°C; the thick paste is dried under reduced pressure at a temperature of -0.06-0.08MPa and 70-80°C, and crushed into fine powder for standby use;

[0012] The second step is to add appropriate amount of auxiliary materials to the prepared dry paste powder and mix it evenly, and make it into an oral dosage form using conventional technology.

[0013] Furthermore, the auxiliary material is: one of microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, micro-powder silica gel, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch, or a mixture of any of them.

[0014] The above-mentioned drugs can be made into any other oral preparations in pharmacy, such as tablets, granules, capsules, powders, pills, oral liquids, etc.

[0015] The pharmacological effects of the components and their combinations are analyzed as follows:

[0016] The purpose of the present invention is to give full play to the compatibility of Chinese medicine. The Bupleurum in the prescription is bitter and slightly cold. It enters the liver and gallbladder meridians. It soothes the liver and relieves depression, and raises yang. White peony root tastes bitter and sour, is slightly cold in nature, enters the liver and spleen meridians, nourishes liver blood to make the liver body supple, and restrains liver yin to suppress liver yang. The two are the monarchs, soothing the liver and relieving depression. Cyperus rotundus tastes pungent, slightly bitter, and sweet, is flat in nature, enters the liver, spleen, and triple burner meridians, and is "the general manager of qi disease and the commander of gynecology", and has the functions of promoting qi and relieving depression, and relieving and relieving. Curcuma is pungent, bitter, and cold. It enters the liver, heart, and lung meridians, and promotes qi and relieves depression. Cyperus rotundus and Curcuma help Bupleurum to soothe the liver and regulate qi, regulate qi and blood, make qi and blood smooth, and harmonize yin and yang, and are the ministers. Acanthopanax is slightly bitter and warm in nature. It enters the spleen, kidney, and heart meridians, replenishes qi and strengthens the spleen, and nourishes the kidney and calms the mind. Morinda officinalis is slightly warm in nature, sweet and pungent in taste. It enters the kidney meridian and liver meridian. It can tonify kidney yang and strengthen tendons and bones. Schisandrae Chinensis is sweet and sour, warm in nature, and enters the heart and kidney meridians, nourishes the kidney and produces body fluid, and prevents liver fire from consuming body fluid and damaging yin. Albizzia Julibrissin bark is sweet and flat. It enters the heart, liver, and lung meridians. It can relieve depression and calm the mind. Gardenia jasminoides is bitter and cold. It enters the heart, lung, and triple burner meridians. It can purge fire and relieve restlessness, and prevent liver depression from turning into fire. The above ingredients are used as adjuvants. Licorice is used to harmonize the other medicines. The whole formula can play the role of soothing the liver and regulating qi, strengthening the spleen and tonifying the kidney, relieving depression and calming the mind; functional tests have confirmed that the present invention has obvious effects in preventing and treating depression.

[0017] Modern pharmacological research has confirmed that:

[0018] Bupleurum, slightly bitter in taste, is mainly used to soothe the liver; it has the effects of soothing the liver and relieving depression, and promoting the flow of liver qi. Modern pharmacological studies have shown that Bupleurum can exert antidepressant effects by regulating the neuroendocrine system and improving inflammatory signaling pathways. Su et al. injected lipopolysaccharide (LPS, 0.83 mg / kg) to induce a depression model in male ICR mice, and conducted a behavioral test experiment similar to depression. The results showed that Bupleurum saponin D in Bupleurum can improve the inflammatory signaling pathway and effectively alleviate LPS-induced inflammation-related depression behavior. Chao et al. induced a male Sprague-Dawley rat depression model by using unpredictable chronic mild stress, and conducted SPT, FST, TST and open field test (OFT). The results showed that Bupleurum saponin D can improve the depression behavior of rats induced by UCMS through the NFκB / miR-155 / FGF2 axis. Chen et al. selected female Wistar rats, also created a UCMS rat depression model, and conducted SPT test, FST test and novelty-suppressed feeding test (OFT). test, NSFT); the results showed that saikosaponin A exerts its antidepressant effect by improving the neuroendocrine, neuroinflammatory and neurotrophic systems.

[0019] White peony root nourishes blood and regulates menstruation, restrains yin and stops sweating, softens the liver and relieves pain, and calms liver yang; Bupleurum and white peony root are commonly used clinical compatibility drugs; the two drugs were first recorded in Shennong's Herbal Classic, and Bupleurum is a drug for dispelling exterior pathogens, which can regulate liver qi and regulate gastrointestinal qi; although Bupleurum and peony have different functions, they are used together in the same prescription, which is a basic prescription for dispelling exterior pathogens, soothing the liver and relieving depression; clinical application has anti-depression and anti-insomnia effects. Chen Guixia used Bupleurum and white peony root as the basic prescription to treat post-stroke depression. After 8 weeks of treatment, the total effective rate of the treatment group was 86.7%, and that of the control group was 71.1% (P<0.05), indicating that the combination of Bupleurum and white peony root in the prescription is effective in treating post-stroke depression. Li Yuelan et al. divided the decoction of Paeonia lactiflora into high, medium and low concentration groups to study its effects on brain neurotransmitters in rats with chronic stress depression. The results showed that with the increase of the concentration of Paeonia lactiflora, the expression levels of DA, NE and 5-HT in depressed rats can be gradually improved, and it has a significant therapeutic effect on depressed rats.

[0020] Cyperus rotundus can soothe the liver and relieve depression, regulate qi and relieve fullness, and is used for liver depression and qi stagnation. Modern research has further confirmed that the main ingredients of Chaihu Shugan San (Bupleurum-Cyperus rotundus) have significant therapeutic effects in anti-depressant treatment. Further studies have found that Chaihu Shugan San can improve the depressive state of rats through multiple mechanisms such as increasing the expression level of 5-HT in the hippocampus and increasing brain-derived neurotrophic factor.

[0021] Curcuma has the effects of promoting blood circulation, activating qi and relieving pain, clearing the heart and relieving depression. It has the effects of regulating neurotransmitters, inhibiting neuroinflammation, protecting neurons, regulating neuroendocrine, and anti-thrombosis, which can prevent and treat post-stroke depression through multiple components, multiple targets, and multiple pathways. β-sitosterol is a major plant sterol contained in Curcuma. Studies have found that β-sitosterol can significantly increase the levels of 5-HT and NE in the brains of depressed mice and relieve the depressive-like behavior of mice. However, due to the chemical structure of plant sterols, the solubility of β-sitosterol in water and oils is extremely low, which limits its application. Therefore, Liu Xiaofeng et al. used four organic acids to react with β-sitosterol to generate corresponding lipid derivatives, which increased the solubility of β-sitosterol. They found that the lipid derivatives of β-sitosterol and salicylic acid can significantly increase the levels of 5-HT and dopamine (DA) in the brains of depressed mice and improve the depressive-like behavior of mice.

[0022] Acanthopanax, mainly belongs to the spleen, kidney and heart meridians, and has the effects of invigorating qi and strengthening spleen, nourishing kidney and calming the mind; it is frequently used as a tonic drug to treat depression; most people with depression tendency and patients with depression will experience the above symptoms, so Acanthopanax and its preparations are often seen in clinical and experimental studies of depression. Zhou Jinli used Acanthopanax injection for acupoint injection to treat 96 patients with depression, with a significant efficacy of 79.17% and an effective rate of 95.83%; Lan Likang et al. observed the efficacy and safety of Acanthopanax for mild and moderate depression and found that the effective rates of the Acanthopanax group and the Delexin group were 77% and 80%, respectively, and there was no difference in efficacy between the groups; Acanthopanax extracts and chemical components have a dual effect of improving vascular disease and depression symptoms for diseases with cerebrovascular disease combined with depression, such as vascular depression and post-stroke depression.

[0023] Morinda officinalis can replenish kidney yang and strengthen muscles and bones. Studies have found that Morinda officinalis contains a variety of active ingredients, such as sugars, anthraquinones, cyclopentane and amino acids. The sugar components in Morinda officinalis can not only improve the body's immunity and memory, but also have antioxidant and anti-aging effects and show good anti-depressant activity. Among them, the oligosaccharide components show good anti-depressant activity. The results show that Morinda officinalis oligosaccharides can significantly promote the regeneration of hippocampal neurons in adult mice and increase the number of dendrites and branches of primary cultured hippocampal neurons. This regulation of hippocampal neural plasticity may be one of its anti-depressant mechanisms. In addition, the anti-depressant mechanism of Morinda officinalis oligosaccharides may also be achieved by affecting the neurotrophic factor pathway and regulating synaptic plasticity.

[0024] Schisandra chinensis has the effects of astringency, replenishing qi and promoting the production of body fluid, nourishing the kidney and calming the mind, and can be used for palpitations and insomnia. The study by Xu Fangmin et al. showed that the use of schisandrae alcohol A to intervene in depressed mice significantly reduced the depressive behavior compared with the normal group. The study by Yan et al. found that Schisandra chinensis has a therapeutic effect on the depressive behavior caused by unpredictable stress stimulation in rats and the anxious behavior caused by sleep deprivation. Xie Gang et al. used the forced swimming experiment in rats and the tail suspension experiment in mice to study the antidepressant effect of Schisandra chinensis. The above models induce a depressive-like state of despair in mice by exposing them to inescapable stress. The results showed that Schisandra chinensis extract can effectively enhance the excitability of mice, reduce the occurrence of the above state of despair in mice, and has a significant antidepressant effect.

[0025] Albizzia julibrissin bark is used to relieve depression and soothe the mind, and is used to treat restlessness, depression and insomnia. Modern pharmacological studies have shown that Albizzia julibrissin bark can improve the conduction of nerve signals by enhancing the functions of neurotransmitters such as serotonin (5-HT) and γ-aminobutyric acid (GABA), thereby relieving mental symptoms such as anxiety and depression. Secondly, it has an effect similar to that of antidepressants, regulating the balance of neurochemical substances in the brain and improving emotional stability. Liao Ying et al. used Albizzia julibrissin bark extract to demonstrate antidepressant effects on the mouse tail suspension model, forced swimming model and reserpine-induced depression model.

[0026] Gardenia jasminoides can relieve fire and relieve restlessness, clear away heat and remove dampness; modern pharmacological studies have found that gardenia jasminoides has anti-inflammatory and choleretic effects, and its chemical components include iridoids, monoterpenoids, diterpenoids, triterpenoids, flavonoids, etc. Among them, the iridoid component gardenia glycoside and its aglycone genipin, and the diterpenoid compound crocin are its main antidepressant components; there are also reports that hydroxyisogarabinoside can be used to treat depression by regulating the HPA axis.

[0027] Roasted licorice root is warm in nature and can replenish qi and nourish the middle, nourish the spleen and stomach, and restore qi and pulse. It is used for people with weak spleen and stomach, deficiency of qi and blood, and imbalance of yin and yang, and has a good effect. Modern medical research shows that roasted licorice root has anti-depression, improves immune function, regulates arrhythmia, anti-tumor, and anti-inflammatory effects. A large number of literatures show that licorice glycosides and total flavonoids of licorice are the basic substances for licorice to exert its anti-depression effect, and the content of total flavonoids and licorice glycosides in roasted licorice root is higher, which is more suitable for the treatment of depression.

[0028] In order to demonstrate the effect of the present invention on the prevention and treatment of depression, the clinical trial report of the present invention is provided as follows:

[0029] 1. Research subjects

[0030] 1.1 Selection criteria

[0031] ①According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-Ⅳ-TR), the patient meets the diagnostic criteria for a depressive episode.

[0032] ②The total score of Hamilton Depression Rating 17 (HAMD-17) scale is ≥17 points and ≤24 points.

[0033] ③The number of depressive episodes is ≤ 3 times, and the duration of this depressive episode is < 2 years.

[0034] ④Chinese medicine diagnosis is liver depression and kidney deficiency syndrome.

[0035] ⑤Age: 18 to 65 years old, no gender restrictions.

[0036] ⑥After a 1-week placebo run-in period, the HAMD score reduction rate compared with the screening score was <25%.

[0037] ⑦ Those who voluntarily sign the informed consent form.

[0038] 1.2 Exclusion criteria

[0039] ① Suicidal tendencies (HAMD scale item 3 “Suicide” score > 1).

[0040] ② Severe anxiety (HAMA anxiety scale>21 points).

[0041] ③ Patients with depressive episodes or bipolar disorder secondary to other mental or physical illnesses.

[0042] ④ Patients with severe or unstable heart, liver, kidney, endocrine, blood and other medical diseases; patients with epilepsy; those with liver function test >1.5 times the upper limit of normal value.

[0043] ⑤ Those who have been addicted to alcohol or drugs within 1 year.

[0044] ⑥ Those who have taken sedatives, antidepressants or liver-soothing and depression-relieving Chinese medicine one week before enrollment; those who have taken monoamine oxidase inhibitors, fluoxetine, clozapine, or received electric shock therapy within 4 weeks.

[0045] ⑦ Those with poor compliance and unable to take medication as prescribed by the doctor.

[0046] ⑧People with allergic constitution.

[0047] ⑨ Pregnant or lactating women or those planning to become pregnant.

[0048] ⑩Patients who have participated in other drug clinical trials within the past month.

[0049] 2. Research design

[0050] Test group: Capsules of this product

[0051] Control group: capsule simulant of this product

[0052] The two groups used the same outer packaging, and the color and smell of the contents were basically the same.

[0053] Dosage method: 1-week lead-in period, taking the capsule simulation of this product. After the 1-week lead-in period, patients whose HAMD-17 reduction rate compared with baseline is <25% and whose medication compliance is >80% will enter an 8-week treatment period.

[0054] 3. Dosage regimen

[0055] 3.1 Introduction period (1 week): Both groups took the simulated capsule of this product, 3 capsules / time, 3 times / day.

[0056] 3.2 Treatment period (8 weeks):

[0057] Experimental group: Take this product capsule, 3 capsules / time, 3 times / day.

[0058] Control group: Take the simulated capsule of this product, 3 capsules / time, 3 times / day.

[0059] 3.3 Treatment and Medication Provisions During the trial, any antipsychotic drugs, antidepressants, mood stabilizers (sodium valproate, lithium carbonate), electric shock and transcranial magnetic stimulation treatments are prohibited. Other Chinese herbal decoctions and related preparations with the effects of soothing the liver and regulating qi, invigorating qi and strengthening the spleen, and tonifying the kidneys are not allowed.

[0060] 4. Efficacy evaluation

[0061] Main efficacy evaluation index: HAMD-17 scale score reduction value at the 8th week of treatment;

[0062] Secondary evaluation indicators: score reduction values ​​at the end of 1, 2, 4, and 6 weeks after treatment and the score reduction rate at each time point;

[0063] The efficacy of TCM syndrome and single symptom.

[0064] HAMD-17 score reduction rate = (baseline total score - total score after treatment) / baseline total score × 100%. Clinical recovery: HAMD-17 total score ≤ 7 points

[0065] Effective: Reduction rate ≥ 50%

[0066] Invalid: Reduction rate < 50%

[0067] 5. Safety evaluation

[0068] Observation of general physical examination items, routine blood test, routine urine test, routine stool test, electrocardiogram, liver function test (ALT, AST, GGT, ALP, TBIL), renal function test (BUN, Cr) and adverse events.

[0069] 6. Statistical methods

[0070] SAS 9.4 software was used for statistical analysis.

[0071] The full analysis set (FAS) was used for demographics, other baseline characteristics, main variables and comprehensive efficacy; the safety set (SS) was used for safety evaluation.

[0072] Quantitative data were described as mean ± standard deviation, and categorical count data were described as percentages. Paired t-test was used for intra-group comparison, and analysis of variance was used for inter-group comparison. Count data were described as frequency, and chi-square test or rank sum test was used. Covariance analysis model was used to compare the HAMD-17 score reduction values ​​at different time points after treatment.

[0073] 7. Test results

[0074] 7.1 Subject Enrollment and Completion Status

[0075] A total of 116 cases were enrolled in the two groups, 6 of whom dropped out, with a dropout rate of 5.17%. Among them, 2 cases dropped out in the experimental group, with a dropout rate of 1.72%, and 4 cases dropped out in the control group, with a dropout rate of 3.44%.

[0076] Table 1. Subjects enrollment and completion status

[0077]

[0078] 7.2 Analysis of inter-group balance before enrollment

[0079] 7.2.1 General data comparison

[0080] There was no statistically significant difference in the general data (gender, age, height, weight, body temperature, respiration, heart rate, blood pressure, and course of disease) of the two groups (P>0.05), indicating that the general data of the two groups before enrollment were comparable.

[0081] Table 2-1 Comparison of general data between the two groups

[0082]

[0083] 7.2.2 Comparison of diagnosis and HAMD scores before enrollment

[0084] There was no significant difference in the diagnosis, HAMD baseline score and HAMD reduction rate between the two groups before enrollment (P>0.05), indicating that the conditions were comparable to a certain extent at the time of enrollment.

[0085] Table 2-2 Comparison of diagnosis, HAMD baseline score and HAMD reduction rate between the two groups

[0086]

[0087] 7.3 Observation

[0088] 7.3.1 The changes in HAMD-17 scores and their reduction values ​​before and after treatment are shown in Table 3-1.

[0089] Table 3-1 Comparison of HAMD-17 deduction values

[0090]

[0091] The reduction value = HAMD-17 total score at each time point - baseline total score, compared with the baseline of this group.

[0092] 7.3.2 Comparison of Effectiveness

[0093] Table 3-2 Comparison of effective rate n / %

[0094]

[0095]

[0096] 7.4 Safety evaluation

[0097] At the end of the 8th week of treatment, the body temperature, heart rate, respiration, systolic blood pressure, diastolic blood pressure, body weight and other indicators of the patients in each group showed no statistically significant difference compared with those before treatment (P>0.05). No clinically significant changes were found in blood routine, urine routine, stool routine + occult blood test, liver function, kidney function and electrocardiogram before and after treatment.

[0098] No adverse events or serious adverse events were observed in both groups. DETAILED DESCRIPTION

[0099] Example 1

[0100] The Chinese medicine composition for preventing and treating depression described in this embodiment is made of the following medicinal ingredients in parts by weight:

[0101] 3 parts of bupleurum, 6 parts of white peony root, 5 parts of cyperus, 3 parts of curcuma, 10 parts of acanthopanax, 6 parts of morinda officinalis, 2 parts of schisandra, 6 parts of julibrissin bark, 6 parts of gardenia, and 3 parts of roasted liquorice.

[0102] The specific preparation method comprises the following steps, calculated by weight:

[0103] The first step is to take 3 parts of bupleurum, 6 parts of white peony root, 5 parts of cyperus, 3 parts of curcuma, 10 parts of acanthopanax, 6 parts of Morinda officinalis, 2 parts of Schisandra chinensis, 6 parts of Albizzia julibrissin, 6 parts of Gardenia jasminoides, and 3 parts of licorice root in the above weight parts; add 8 times the amount of water to the above weight parts of the medicinal flavors and boil for 1 hour, filter through 200 mesh, and concentrate the filtrate under reduced pressure at a temperature of -0.06MPa and 60°C until it is concentrated to a thick paste with a relative density of 1.30; and measure the relative density value at 60°C; the thick paste is dried under reduced pressure at a temperature of -0.06MPa and 70°C, and crushed into fine powder for standby use;

[0104] In the second step, the prepared dry paste powder is added with an appropriate amount of microcrystalline cellulose and mixed evenly, and then made into an oral dosage form using conventional technology.

[0105] Example 2

[0106] The Chinese medicine composition for preventing and treating depression described in this embodiment is made of the following medicinal ingredients in parts by weight:

[0107] 20 parts of bupleurum, 30 parts of white peony root, 20 parts of cyperus, 20 parts of curcuma, 30 parts of acanthopanax, 20 parts of morinda officinalis, 12 parts of schisandra, 20 parts of julibrissin bark, 15 parts of gardenia, and 9 parts of roasted liquorice.

[0108] The specific preparation method comprises the following steps, calculated by weight:

[0109] The first step is to take 20 parts of bupleurum, 30 parts of white peony root, 20 parts of cyperus, 20 parts of curcuma, 30 parts of acanthopanax, 20 parts of Morinda officinalis, 12 parts of schisandra, 20 parts of julibrissin bark, 15 parts of gardenia, and 9 parts of licorice root in the above weight parts; add 12 times the amount of water to the above weight parts of the medicinal flavors and boil them 3 times, each time for 2 hours, filter through 200 mesh, and concentrate the filtrate under reduced pressure at 0.08MPa and 70°C until it is concentrated to a thick paste with a relative density of 1.30; and measure the relative density value at 60°C; the thick paste is dried under reduced pressure at 0.08MPa and 80°C, and crushed into fine powder for standby use;

[0110] In the second step, the prepared fine powder is added with an appropriate amount of starch and mixed evenly, and then made into an oral dosage form using conventional technology.

[0111] Example 3

[0112] The Chinese medicine composition for preventing and treating depression described in this embodiment is made of the following medicinal ingredients in parts by weight:

[0113] 15 parts of bupleurum, 20 parts of white peony root, 15 parts of cyperus, 15 parts of curcuma, 20 parts of acanthopanax, 10 parts of morinda officinalis, 8 parts of schisandra, 15 parts of julibrissin bark, 10 parts of gardenia, and 6 parts of preparatory liquorice.

[0114] The specific preparation method comprises the following steps, calculated by weight:

[0115] The first step is to take 15 parts of bupleurum, 20 parts of white peony root, 15 parts of cyperus, 15 parts of curcuma, 20 parts of acanthopanax, 10 parts of Morinda officinalis, 8 parts of schisandra, 15 parts of julibrissin, 10 parts of gardenia, and 6 parts of licorice root in the above weight parts; add 10 times the amount of water to the above weight parts of the medicinal flavors and boil for 2 times, each time for 1.5 hours, filter through 200 mesh, and concentrate the filtrate under reduced pressure at a temperature of -0.07MPa and 65°C until it is concentrated to a thick paste with a relative density of 1.30; and measure the relative density value at 60°C; the thick paste is dried under reduced pressure at a temperature of -0.07MPa and 75°C, and crushed into fine powder for standby use;

[0116] In the second step, the prepared dry paste powder is added with an appropriate amount of sucrose and mixed evenly, and then made into an oral dosage form using conventional technology.

[0117] The auxiliary material can also be one of lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, micro-powder silica gel, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch, or a mixture of any of them.

Claims

1. A Chinese medicine composition for preventing and treating depression, characterized in that: Made from the following medicinal ingredients by weight: 3-20 parts of bupleurum, 6-30 parts of white peony root, 5-20 parts of cyperus, 3-20 parts of curcuma, 10-30 parts of acanthopanax, 6-20 parts of morinda officinalis, 2-12 parts of schisandra, 6-20 parts of julibrissin bark, 6-15 parts of gardenia, and 3-9 parts of roasted liquorice.

2. A method for preparing the Chinese medicine composition for preventing and treating depression according to claim 1, characterized in that: The method comprises the following steps, calculated by weight: The first step is to take 3-20 parts of bupleurum, 6-30 parts of white peony root, 5-20 parts of cyperus, 3-20 parts of curcuma, 10-30 parts of acanthopanax, 6-20 parts of Morinda officinalis, 2-12 parts of Schisandra chinensis, 6-20 parts of Albizzia julibrissin, 6-15 parts of Gardenia jasminoides, and 3-9 parts of licorice root in the above weight parts; add 8-12 times the amount of water to the above weight parts of the medicinal flavors, decoct 1-3 times, each time for 1-2 hours, filter through 200 mesh, and concentrate the filtrate under reduced pressure at a temperature of -0.06-0.08MPa and 60-70°C until it is concentrated to a thick paste with a relative density of 1.30; and measure the relative density value at 60°C; the thick paste is dried under reduced pressure at a temperature of -0.06-0.08MPa and 70-80°C, and crushed into fine powder for standby use; In the second step, the prepared fine powder is added with appropriate amount of auxiliary materials and mixed evenly, and then made into an oral dosage form by conventional technology.

3. The method for preparing the Chinese medicine composition for preventing and treating depression according to claim 2, characterized in that: The auxiliary materials are: one of microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, micro-powder silica gel, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch, or a mixture of any of them.

4. The method for preparing the Chinese medicine composition for preventing and treating depression according to claim 2, characterized in that: The above-mentioned drugs can be made into any other oral preparations in pharmacy, such as tablets, granules, capsules, powders, pills, oral liquids.

Citation Information

Patent Citations

  • Liver-soothing and qi-regulating traditional Chinese medicine composition used for treating depression, and preparation method thereof

    CN103083505A

  • Traditional Chinese medicine specially used for treating tristimania

    CN104922274A

  • Traditional Chinese medicine for treating liver depression insomnia

    CN105535849A

  • Medicine for soothing liver-qi stagnation to relieve depression

    CN108159352A

  • Chinese medicine for treating depression and anxiety

    CN1395956A