Medicine for treating periodic psychosis

Abstract

The invention relates to the technical field of medicines, and discloses a medicine for treating periodic psychosis, which comprises the following components: pinellia ternate, pericarpium citri reticulatae, poria cocos, immature bitter orange, bamboo shavings, liquorice, ginger, Chinese date, theanine and a cortex albiziae extract. Through the rapid sedation effect of the theanine and the long-acting emotion regulation effect of the cortex albiziae extract, the multi-target synergistic effect is achieved, and the anxiety, depression, emotion fluctuation and sleep disorder symptoms of a patient are effectively improved; according to the composition, a modern extraction and processing technology is adopted, the bioavailability of the medicine is improved, multiple dosage forms such as granules, capsules and tablets are developed, and the compliance of patients is improved. The traditional Chinese medicine composition has the advantages of high efficiency, safety, low side effect and the like, not only can be used for treating periodic psychosis such as bipolar affective disorder and periodic depression, but also is suitable for adjuvant therapy of other affective disorders, and the dependence of patients on traditional western medicines is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of medicine, in particular to a medicine for treating periodic psychosis. Background Art

[0002] With the accelerated pace of life and increasing pressure in modern society, the incidence of periodic mental illnesses (such as bipolar disorder, periodic depression, etc.) has increased year by year, seriously affecting the physical and mental health and quality of life of patients. Such mental illnesses are often manifested as extreme mood swings, including depression, anxiety, mania and other symptoms. The patient's mood swings occur periodically and are often difficult to control. These diseases not only bring pain to the patients themselves, but also increase the burden on their families and society. Effective and safe treatments are urgently needed.

[0003] At present, the treatment methods for periodic psychosis are mainly based on Western medicine. The mechanism of action of Western medicine is usually to regulate emotions by directly affecting the levels of neurotransmitters (such as serotonin, dopamine, etc.) to achieve the effect of relieving symptoms. However, Western medicine is often accompanied by many side effects during treatment, such as drowsiness, weight gain, metabolic disorders, dependence, etc., which not only affects the daily life of patients, but also easily leads to drug dependence. With long-term use of Western medicine, patients may also face the risk of gradual weakening of the efficacy of the medicine, and the treatment effect is difficult to maintain stability. Some patients even choose to interrupt treatment due to severe side effects. In addition, the treatment mode of Western medicine is usually symptomatic treatment. Although it is effective in controlling symptoms in the acute phase, it is often difficult to fundamentally regulate the patient's mood swings and long-term mental state.

[0004] In contrast, Chinese medicine has its unique advantages in the treatment of mental illness. Chinese medicine emphasizes overall conditioning, and regulates emotional state from the overall level of the body by regulating the functions of internal organs, unblocking the qi, replenishing qi and blood, calming the mind and relieving depression, so as to achieve the effect of treating both the symptoms and the root causes. The treatment of Chinese medicine has relatively small side effects and is suitable for long-term conditioning, so it has gradually received attention in the treatment of mental illness. However, traditional Chinese medicine also has certain limitations in efficacy, especially in terms of symptom control in the acute phase. Compared with Western medicine, it takes longer to take effect and is difficult to meet patients' needs for rapid relief. In addition, the concentration of active ingredients and the mechanism of action of traditional Chinese medicine formulas often lack the support of modern science, making it difficult to accurately regulate the balance of neurotransmitters. Summary of the invention

[0005] In view of the deficiencies of the prior art, the present invention provides a drug for treating periodic psychosis, and provides a Chinese medicine composition that can quickly relieve anxiety, stabilize emotions for a long time, and has high efficiency and low side effects, which is used to treat periodic psychosis and related emotional disorders.

[0006] To achieve the above objectives, the present invention is implemented through the following technical scheme: a Chinese medicine composition for treating periodic psychosis, comprising the following components: pinellia, tangerine peel, poria, immature bitter orange, bamboo shavings, licorice, ginger, jujube, theanine and julibrissin bark extract.

[0007] Preferably, the weight proportions of each component are: 10-15 parts of Pinellia, 6-9 parts of Tangerine Peel, 9-12 parts of Poria, 6-9 parts of Citrus Aurantium, 6-9 parts of Rhizoma Anemarrhenae, 3-5 parts of Licorice, 6-9 parts of Ginger, 3-5 parts of Jujube, 0.1-0.2 parts of Theanine, and 0.15-0.3 parts of Albizzia Julibrissin Bark Extract.

[0008] Preferably, the weight proportions of each component are: 12 parts of Pinellia, 8 parts of Tangerine Peel, 11 parts of Poria, 8 parts of Citrus Aurantium, 8 parts of Rhizoma Anemarrhenae, 4 parts of Licorice, 8 parts of Ginger, 4 parts of Jujube, 0.15 parts of Theanine, and 0.25 parts of Albizzia Julibrissin Bark Extract.

[0009] Preferably, the preparation method of each component is as follows: Pinellia tuber, dried orange peel, Poria cocos, immature bitter orange, bamboo shavings, liquorice, ginger, jujube: take the corresponding Chinese medicinal materials, wash and dry them, grind them into coarse powder, add 10 times the amount of water and boil them twice, each time for 1-2 hours, combine the decoctions, filter and concentrate under reduced pressure to obtain Chinese medicinal extracts; Albizzia julibrissin bark extract: The bark was dried and crushed to 20-40 mesh. 2 Extraction, pressure of 20-30MPa, temperature of 35-45°C, extraction for 2-3 hours to obtain an extract; Theanine: Use purified theanine powder and add directly to mix.

[0010] Preferably, the Chinese medicine composition is prepared into granules or capsules for clinical use.

[0011] Preferably, the preparation of the Chinese medicine composition into granules for clinical use comprises the following steps: Mix the extracts of pinellia tuber, dried orange peel, poria, immature bitter orange, bamboo shavings, liquorice, ginger, jujube, Albizzia julibrissin bark extract and theanine powder evenly according to the weight ratio; Wet granulation was carried out at a temperature of 50-60°C, and the particle size was controlled at 0.3-0.5 mm; The wet granules are dried in a hot air drying oven at 60-70°C until the moisture content is less than 5%.

[0012] Preferably, the preparation of the Chinese medicine composition into capsules for clinical use comprises the following steps: Mix the extracts of pinellia tuber, dried orange peel, poria, immature bitter orange, bamboo shavings, liquorice, ginger, jujube, jujube bark extract and theanine powder evenly according to the formula ratio; Add microcrystalline cellulose as a filler and stir well; Carry out vacuum drying to control the moisture content below 5%; The dry mixture is put into capsules.

[0013] Preferably, the Chinese medicine composition is prepared into tablets for clinical use.

[0014] Preferably, the preparation of the Chinese medicine composition into tablets for clinical use comprises the following steps: Mix the extracts of pinellia tuber, dried orange peel, poria, immature bitter orange, bamboo shavings, liquorice, ginger, jujube, jujube bark extract and theanine powder evenly according to the formula ratio; Add microcrystalline cellulose, sodium carboxymethyl starch and povidone K30 and stir well; Add appropriate amount of ethanol or purified water to moisten, make granules, and dry until the moisture content is less than 5%; Add magnesium stearate lubricant and stir evenly; The dried granules are compressed into tablets to obtain the product.

[0015] The present invention also provides application of the Chinese medicinal composition for treating periodic psychosis in preparing medicine for treating periodic psychosis.

[0016] The present invention provides a drug for treating periodic psychosis. It has the following beneficial effects: 1. The present invention achieves multi-target synergistic effects by introducing theanine and Albizzia julibrissin extract on the basis of traditional Wendan Decoction. Theanine quickly calms the body and Albizzia julibrissin extract regulates the body over a long period of time. The combination of the two significantly enhances the effect of the Chinese medicine composition in relieving anxiety, depression and mood swings. Compared with traditional formulas, the overall therapeutic effect is stronger.

[0017] 2. Theanine has the ability to quickly cross the blood-brain barrier and can quickly increase the level of GABA in the brain, thereby quickly relieving anxiety and improving emotional stability. The improved formula of the present invention can effectively reduce the patient's anxiety symptoms in a short period of time by adding theanine, providing a rapid intervention method for acute mood swings.

[0018] 3. Albizzia julibrissin bark extract is rich in flavonoids and saponins, which can regulate the balance of neurotransmitters and promote the release of serotonin and dopamine, thereby improving depression. The present invention utilizes the long-term action mechanism of Albizzia julibrissin bark to effectively reduce the frequency of mood swings and depression recurrence rate of patients, and improve the continuity and stability of the overall treatment effect.

[0019] 4. All ingredients in the present invention are derived from natural plants, which are safer and less prone to side effects than chemically synthesized drugs. Long-term use will not lead to dependence and addiction, and is more suitable for patients who need long-term mood regulation, thereby reducing the burden of drug side effects.

[0020] 5. Theanine and Albizzia julibrissin extract in the improved Chinese medicine composition not only help relieve anxiety and depression, but also effectively improve the patient's sleep quality. Theanine brings a relaxing effect by regulating GABA levels, and Albizzia julibrissin regulates the balance of neurotransmitters over a long period of time, allowing patients to fall asleep faster and sleep more deeply, which helps improve the patient's overall quality of life.

[0021] 6. The present invention optimizes the extraction and processing steps through modern preparation technology, improves the bioavailability of the drug, makes the active ingredients more fully absorbed in the body, and has a more significant effect. At the same time, a variety of dosage forms such as granules, capsules and tablets have been developed to facilitate patients to take and improve drug compliance.

[0022] 7. The present invention combines the advantages of traditional Chinese medicine with the essence of modern plant extracts to construct an innovative treatment plan that combines the overall conditioning of traditional Chinese medicine with modern pharmacological mechanisms. This combination of Chinese and Western medicine can fundamentally regulate the nervous system, treat both the symptoms and the root causes, and provide a new treatment idea for periodic mental illness.

[0023] 8. The Chinese medicine composition of the present invention improves the patient's physical condition as a whole by regulating the functions of the internal organs, unblocking the qi mechanism, and strengthening the physical fitness, thereby treating both the symptoms and the root causes. Its anti-anxiety and anti-depression effects can not only take effect quickly in the short term, but also gradually restore the patient's physical and mental balance through long-term conditioning and reduce the recurrence of symptoms.

[0024] 9. Traditional treatments for mental illnesses often rely on Western medicine, which may cause side effects such as drowsiness, weight gain, metabolic disorders, etc. The present invention provides a natural, effective alternative or auxiliary treatment solution that can reduce patients' dependence on traditional Western medicine and reduce the adverse reactions caused by long-term use of Western medicine.

[0025] 10. The present invention is not only applicable to cyclical mental illnesses such as bipolar disorder, but also to other emotional disorders such as anxiety, depression, mood swings, sleep disorders, etc. Through the comprehensive treatment of multiple symptoms, the application breadth of the Chinese medicine composition is improved, providing a safe and effective comprehensive solution for patients with various mental and emotional diseases. DETAILED DESCRIPTION

[0026] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only 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 making creative work are within the scope of protection of the present invention.

[0027] The present invention relates to a drug for treating periodic psychosis, which is a formula combining traditional Chinese medicine with modern plant extracts and is used for comprehensive therapy for treating patients with periodic psychosis. The present invention is described in detail below through specific embodiments.

[0028] The Chinese medicine composition of the present invention mainly comprises the following components: pinellia tuber, dried orange peel, poria, immature bitter orange, bamboo shavings, liquorice, ginger, jujube, theanine and albizzia bark extract. The composition is based on the principle of TCM syndrome differentiation and treatment, combined with modern plant extracts, with the main functions of soothing the liver and relieving depression, resolving phlegm and regulating qi, nourishing internal organs, calming the mind and relieving depression, improving patients' mood swings, anxiety, depression symptoms, and enhancing the overall therapeutic effect.

[0029] The specific formula is designed by weight as follows: Element Weight range Preferred weight parts Pinellia 10-15 12 Tangerine peel 6-9 8 Poria 9-12 11 Citrus aurantium 6-9 8 Bamboo Ru 6-9 8 Licorice 3-5 4 Ginger 6-9 8 Jujube 3-5 4 Theanine 0.1-0.2 0.15 Albizia Julibrissin Bark Extract 0.15-0.3 0.25 In the Chinese medicine composition for treating periodic psychosis of the present invention, each component has its own unique effect, and through reasonable compatibility, the overall therapeutic effect is exerted. The following is a detailed description of each component: Pinellia: Pinellia has the functions of drying dampness and resolving phlegm, relieving adverse reactions and stopping vomiting, and dissolving lumps and knots. Chinese medicine believes that mental illness is often related to internal phlegm and dampness. Pinellia can dissolve phlegm and dredge the qi, which helps to improve symptoms such as anxiety and depression. Pinellia can clear the accumulated phlegm and dampness in the body, dredge the meridians, and harmonize the spleen and stomach, thereby relieving symptoms such as depression and chest tightness.

[0030] Tangerine peel: Tangerine peel is mainly used to regulate qi and strengthen the spleen, dry dampness and resolve phlegm, soothe the liver and regulate qi, and regulate the function of the digestive system. Chinese medicine believes that emotional discomfort often leads to liver qi stagnation, and tangerine peel can dredge the qi mechanism, relieve anxiety and emotional instability caused by qi stagnation, and work with other medicinal materials to regulate emotions.

[0031] Poria: Poria has the effects of promoting water and removing dampness, strengthening the spleen and stomach, and calming the mind. Long-term mental stress can affect the spleen and stomach function. Poria can strengthen the spleen and remove dampness, regulate the function of the digestive system, improve the body's water and moisture metabolism, and the calming effect of Poria can help relieve symptoms such as insomnia and anxiety, while improving physical and mental fatigue caused by spleen deficiency and dampness.

[0032] Citrus aurantium: Citrus aurantium can break up qi and eliminate stagnation, resolve phlegm and remove dampness. It is suitable for chest tightness, depression and other symptoms caused by phlegm and dampness. Citrus aurantium helps to dredge the qi of the chest and abdomen, relieve the inner depression, and has a good regulating effect on anxiety and depression caused by poor qi.

[0033] Bamboo Shavings: Bamboo Shavings are used to clear away heat and resolve phlegm, relieve restlessness and stop vomiting. They are suitable for treating restlessness, mood swings and other problems caused by phlegm-heat disturbing the heart. Bamboo Shavings can clear the heart and reduce internal heat, and calm the mind by resolving phlegm and clearing heat, relieving mood swings and anxiety symptoms.

[0034] Licorice: Licorice has the functions of harmonizing various medicines, tonifying the spleen and replenishing qi, clearing away heat and detoxifying, and relieving pain. It is a commonly used coordinating medicine in traditional Chinese medicine formulas. Licorice is used in this formula to harmonize various medicines and help other medicinal materials to play their role. At the same time, the detoxification and qi-tonifying effects of licorice can further enhance the patient's physical fitness and improve the body's disease resistance.

[0035] Ginger: Ginger is used to dispel cold, warm the middle and stop vomiting, and resolve phlegm and stop coughing. Ginger can stimulate the body's yang energy and invigorate the spirit. The warming and cold-dispelling effect of ginger helps to dispel the cold and dampness in the body, harmonize the spleen and stomach, and at the same time soothe the nerves and relieve depression.

[0036] Jujube: Jujube has the effect of nourishing the middle qi, replenishing blood and calming the mind. Jujube is often used in compatibility to nourish qi and blood and regulate the overall state of the body. Jujube can enhance the body's anti-stress ability, help relieve physical discomfort and depression caused by stress, and improve immunity and body energy levels.

[0037] Theanine: Theanine is an amino acid naturally found in tea leaves that has significant sedative and anti-anxiety effects, can help relax and improve sleep. Theanine helps relieve anxiety, enhance relaxation, and help improve concentration and reduce mental stress by regulating the levels of neurotransmitters such as GABA (gamma-aminobutyric acid), serotonin and dopamine in the brain.

[0038] Albizzia Julibrissin Extract: Albizzia Julibrissin Extract has the effects of calming the nerves, relieving depression, and relieving pain. It is often used to treat mental disorders such as insomnia, anxiety, and depression. The flavonoids and saponins in Albizzia Julibrissin can regulate the nervous system and increase the levels of dopamine and serotonin in the brain, thereby relieving depression and anxiety and improving emotional stability.

[0039] The core idea of ​​the design of this Chinese medicine composition is to regulate the overall state of the body through the synergistic effect of multiple Chinese medicinal materials, and fundamentally improve the mood swings, anxiety and depression symptoms of patients with periodic mental illness. The following is the synergistic effect principle of each ingredient in the formula: Regulating Qi and eliminating phlegm, harmonizing Qi: Pinellia tuber, dried orange peel, immature bitter orange, bamboo shavings and ginger work together to resolve phlegm and regulate qi, and improve chest tightness, qi stagnation and other symptoms by regulating the spleen and stomach and unblocking qi. These herbs help relieve the inner depression caused by emotional discomfort, help patients release stress and regulate their physical and mental state.

[0040] Soothes the mind and relieves depression, improves mood: Poria, jujube and Albizzia julibrissin extracts work together to calm the mind and relieve depression, with the focus on soothing nerves, improving insomnia and mood swings. In particular, the addition of Albizzia julibrissin extract enhances the ability to relieve depression symptoms.

[0041] The rapid calming effects of theanine quickly reduce anxiety levels, synergizing with the effects of Poria cocos and Albizzia julibrissin to create a formula that balances fast-acting effects with long-lasting relief.

[0042] Nourish the internal organs and strengthen the body: Licorice, ginger, and jujube can nourish the spleen and stomach, harmonize the internal organs, improve the adverse effects of long-term emotional disorders on the body, and enhance overall disease resistance.

[0043] The tonic effects of these herbs can help patients regain their strength, improve their mental state, and further consolidate the mood-enhancing effects.

[0044] Multi-target action, overall regulation: The various herbal ingredients in this formula regulate a variety of neurotransmitters (such as serotonin, GABA, dopamine, etc.) through different mechanisms of action, helping to quickly relieve anxiety while improving mood swings and depression in the long term.

[0045] Ingredients such as Albizzia Julibrissin bark, theanine, and Poria cocos enhance the tranquilizing and calming effects in different ways, constructing a multi-level treatment plan that can effectively reduce the recurrence frequency of periodic mental illness.

[0046] The present invention selectively combines Chinese medicinal materials with the functions of resolving phlegm and regulating qi, calming the nerves and relieving depression, and nourishing the internal organs, and combines them with modern plant extracts to develop a Chinese medicine composition with multi-target effects. Each medicinal material plays a synergistic effect in regulating the functions of the internal organs, improving mood and strengthening physical fitness, which not only improves the therapeutic effect, but also reduces the burden of side effects on patients, thereby providing a safe and effective drug option for the comprehensive treatment of periodic mental illness.

[0047] The Chinese medicine composition of the present invention combines scientific compatibility with modern extraction technology, and introduces the preparation process of each step in detail to ensure the effectiveness and stability of the medicine. The following is a specific preparation method, including extraction process, mixing process, molding process, etc., to form a variety of clinical application forms of granules, capsules and tablets.

[0048] Extraction process of Chinese medicine composition Extracts of pinellia tuber, tangerine peel, poria, immature bitter orange, bamboo shavings, liquorice, ginger, and jujube: 1. Raw materials preparation: Take each component in the formula (Pinellia, dried tangerine peel, Poria, Citrus aurantium, Rhizoma Anemarrhenae, Licorice, Ginger, and Jujube), remove impurities, and rinse them separately with clean water.

[0049] Place the washed Chinese medicinal materials in a cool place to dry, and grind them into coarse powder (60-80 mesh).

[0050] 2. Soaking and decoction: Mix the processed Chinese medicinal materials according to the formula ratio, add 10 times the amount of pure water and soak for 30-60 minutes.

[0051] After soaking, boil the mixture, control the temperature at 95-100°C, and keep boiling for 1-2 hours.

[0052] After the first decoction is completed, the extract is filtered and the residue is retained.

[0053] 3. Secondary decoction: Add 8 times the amount of water to the residue and repeat the above decoction steps for 1 hour.

[0054] The extracts from the two decoctions were combined and filtered through a 200-mesh filter to remove the residue and ensure the purity of the extract.

[0055] 4. Concentration: The combined extracts were concentrated by vacuum distillation at 60-70°C to a thick paste, with the concentration ratio controlled at 10:1.

[0056] By reducing pressure and concentrating, the activity of active ingredients can be effectively retained and the damage of high temperature to heat-sensitive ingredients can be reduced.

[0057] 5. Drying: The concentrated extract is spray dried using a spray drying device with the drying temperature set at 60-80°C to obtain a fine powdered extract.

[0058] The dried Chinese medicine powder should be stored in a sealed, dry, light-proof container to prevent moisture absorption and oxidation.

[0059] Preparation of Albizzia Julibrissin Bark Extract: 1. Raw material processing: Take the bark of Albizzia julibrissin, dry it, and grind it into 20-40 mesh fine powder to ensure the extraction rate of the active ingredients.

[0060] 2. Supercritical CO 2 extraction: The Albizzia julibrissin powder was placed in supercritical CO 2 In the extraction device, the extraction conditions are set to 20-30 MPa pressure, 35-45°C temperature, and the extraction time is 2-3 hours.

[0061] By regulating CO 2 The flow rate and extraction time are optimized to ensure efficient extraction of flavonoids and saponins active ingredients in the bark of Albizzia julibrissin.

[0062] After the extraction is completed, the extract is collected, cooled and dried for later use.

[0063] Theanine treatment: Directly use purified theanine powder, weigh it according to the formula ratio, and store it in a sealed container to ensure that it is not exposed to moisture during the preparation process.

[0064] Mixing process of Chinese medicine composition 1. Weigh each extract powder (Pinellia tuber, dried orange peel, Poria cocos, Citrus aurantium, Rhizoma Anemarrhenae, Licorice, Ginger, Jujube, Albizzia julibrissin peel extract, Theanine) according to the formula ratio to ensure the accuracy of each ingredient.

[0065] 2. Place the weighed components in a high-speed blender and mix at 50-60°C for 20-30 minutes to ensure uniform distribution of the ingredients.

[0066] The mixture can be further processed by ultrasonic homogenization equipment for 5-10 minutes to improve the mixing uniformity of the components and ensure the stability of the active ingredients in each dose.

[0067] Granule preparation process: 1. Wet granulation: The evenly mixed extract powder is placed in a granulator according to proportion, and an appropriate amount of 70-80% ethanol is gradually added as a binder to form wet granules.

[0068] The particle diameter is controlled at 0.3-0.5 mm by a rotary granulator to ensure uniform particle size.

[0069] 2. Drying: The wet granules are sent into a hot air drying oven with the drying temperature set at 60-70°C for 4-6 hours until the moisture content of the granules is less than 5%.

[0070] The dried particles should have a smooth surface, not easy to break and have good fluidity.

[0071] 3. Packaging: The prepared granules are sealed and packaged in a clean environment to ensure that the granules are moisture-proof and pollution-free.

[0072] Capsule preparation process: 1. Mixing and drying: After mixing all the components in proportion, add microcrystalline cellulose (10-15%) as a filler and mix again for 10-15 minutes.

[0073] The mixture was dried in a vacuum drying oven at 50-60°C for 2-4 hours to ensure that the moisture content was less than 5%.

[0074] 2.Capsule filling: Use an automatic capsule filling machine to fill the dried mixture into size 0 capsules, each capsule weighing 0.5-1.0 g.

[0075] After the capsules are filled, they are sealed and sampled and tested to ensure the stability and quality of each batch of products.

[0076] Tablet preparation process: 1. Granule mixing and granulation: Evenly mix the extracts of pinellia tuber, tangerine peel, poria, immature bitter orange, bamboo shavings, licorice, ginger, jujube, jujube bark extract and theanine powder according to the formula ratio.

[0077] Add microcrystalline cellulose, sodium carboxymethyl starch and povidone K30 in a ratio of 5-10% and stir to mix.

[0078] Add appropriate amount of 70% ethanol or purified water to moisten and make granules with a particle size of 0.5-1.0 mm.

[0079] 2. Drying and lubrication: The wet granules were dried in a hot air drying oven at 60-70°C until the moisture content was less than 5%.

[0080] Add magnesium stearate (0.5-1%) as a lubricant and mix well.

[0081] 3. Tablet forming: Use an automatic tablet press to press the dried granules into tablets, control the weight of each tablet to 0.5-1.0g, and ensure that the tablet surface is smooth, the hardness is moderate, and the disintegration is good.

[0082] 4. Coating (optional): The tablets can be film-coated with polyethylene glycol and hydroxypropyl methylcellulose as the coating materials, and spray-coated at 35-45°C.

[0083] The coated tablets have good appearance and taste, which enhances the patient's taking experience.

[0084] 5. Packaging and storage: The finished tablets are packaged in aluminum-plastic blisters or sealed bottles in a closed, sterile environment and stored in a cool and dry place to ensure stable efficacy.

[0085] Through the above-mentioned preparation process, the Chinese medicine composition of the present invention can be scientifically formulated, rationally extracted and efficiently processed to be made into a variety of dosage forms for patients to choose and use. The modern technology in the preparation process ensures the stability and safety of product quality, and provides a new high-efficiency, low-side effect drug option for the comprehensive treatment of periodic mental illness.

[0086] The Chinese medicine composition of the present invention can be used to treat periodic mental illness, including bipolar disorder, periodic depression and anxiety. On the basis of conventional treatment, the patient orally takes the granules, capsules or tablets of the present invention 2-3 times a day for a course of 4-6 weeks. By continuously taking the Chinese medicine composition, the patient's mood swings, anxiety and depression symptoms are significantly improved, the sleep quality is improved, and the recurrence rate of periodic mental illness is reduced.

[0087] Experimental Example 1: Neurotransmitter Level Regulation Experiment Objective: To verify the regulatory effect of the improved Chinese medicine composition of the present invention on neurotransmitters (such as serotonin, GABA, dopamine), and to prove its role in anti-anxiety, anti-depression and mood stabilization.

[0088] Experimental Materials Cell line: PC12 neural cells Experimental drugs: Traditional Wendan Decoction Extract (Control Group) Improved Chinese herbal medicine composition extract (containing theanine and Albizzia julibrissin bark extract) Pure theanine, Albizzia julibrissin extract Culture medium: DMEM high glucose medium containing 10% fetal bovine serum Neurotransmitter detection kits: GABA, serotonin, and dopamine ELISA kits Experimental equipment: cell culture box, high-speed centrifuge, microplate reader Experimental setup 1. Experimental group: Blank control group: cultured PC12 cells without any drug treatment.

[0089] Traditional Wen Dan Tang group: cultured PC12 cells, added with the extract of Traditional Wen Dan Tang.

[0090] Improved Chinese medicine composition group: cultured PC12 cells were added with the improved Chinese medicine composition extract.

[0091] Theanine group: cultured PC12 cells, added with pure theanine.

[0092] Albizzia Julibrissin Bark Extract Group: cultured PC12 cells were added with Albizzia Julibrissin Bark Extract.

[0093] 2. Treatment dose: Traditional Wendan Decoction Extract: 50 µg / mL Improved Chinese herbal medicine extract: 50 µg / mL Theanine: 10 µg / mL Albizia Julibrissin Bark Extract: 10 µg / mL 3. Processing time: 48 hours Experimental procedures 1. Cell culture: PC12 cells were inoculated into culture plates and cultured in DMEM high-glucose medium (containing 10% fetal bovine serum) at 37°C and 5% CO 2 Incubate under 4% CO2.

[0094] The cells were treated with the experiment when they reached the logarithmic growth phase.

[0095] 3. Drug treatment: Each group of cell culture plates was set up in the experiment, and the corresponding drugs were added according to the above dosages, while the blank control group was not added with drugs.

[0096] After 48 h of treatment, the cell culture medium was collected and the supernatant was collected after centrifugation using a high-speed centrifuge (3000 rpm, 10 min).

[0097] 4. Neurotransmitter detection: GABA, serotonin, and dopamine ELISA kits were used to detect the neurotransmitter concentrations in the supernatant of each group according to the kit instructions.

[0098] The results were read on a microplate reader and the neurotransmitter levels of each group were recorded.

[0099] The experimental results are shown in the following table: Experimental Group GABA (ng / mL) Serotonin (ng / mL) Dopamine (ng / mL) Blank control group 150 ± 10 120 ± 8 90 ± 6 Traditional Wendan Decoction Group 180 ± 12 145 ± 10 110 ± 8 Improved Chinese medicine combination group 240 ± 15 190 ± 12 150 ± 10 Theanine group 220 ± 13 175 ± 11 130 ± 9 Albizzia Julibrissin Extract Group 210 ± 14 160 ± 10 125 ± 8 From the data in the above table, we can get: 1. Analysis of changes in neurotransmitter levels: In the improved Chinese medicine composition group, the levels of GABA, serotonin and dopamine were significantly higher than those in the blank control group and the traditional Wen Dan Tang group, indicating its enhanced effect in regulating neurotransmitters.

[0100] Theanine and Albizzia Julibrissin extract groups also significantly increased neurotransmitter levels, especially GABA and serotonin, when used alone, demonstrating the roles of these two ingredients in anti-anxiety, anti-depression and mood stabilization.

[0101] 2. Innovative advantages of improved Chinese medicine compositions: GABA level: Theanine in the modified Chinese medicine composition significantly increases GABA levels (240 ng / mL) by promoting the synthesis and release of GABA, allowing cells to exhibit stronger sedative and inhibitory neurotransmitter effects after drug treatment, helping to reduce anxiety and calm the mind.

[0102] Serotonin levels: Theanine and Albizzia Julibrissin extract work synergistically to promote the activation of the serotonin synthesis pathway, thereby increasing the serotonin level in neurons (190 ng / mL), which has a direct effect on mood regulation and the relief of depressive symptoms.

[0103] Dopamine level: In the improved combination, the flavonoids in the Albizia Julibrissin bark extract help enhance dopamine synthesis. The experimental results showed that the dopamine level reached 150 ng / mL, which was significantly higher than that of the traditional group and the single group, helping to enhance patients' sense of pleasure and anti-depressant effect.

[0104] 3. Theanine of the present invention can quickly cross the blood-brain barrier and directly act on the GABA receptors in the brain, promoting the synthesis and release of GABA, thereby increasing the level of inhibitory neurotransmitters and bringing about a relaxing and soothing effect. In addition, theanine can further enhance the anti-anxiety and anti-depressant effects by increasing the levels of serotonin and dopamine.

[0105] The flavonoids and saponins in Albizzia Julibrissin extract can regulate the nervous system and activate the synthesis pathways of neurotransmitters, especially serotonin and dopamine. The increase of serotonin helps to improve mood stability, and the increase of dopamine helps to enhance pleasure and anti-depressant effects.

[0106] The combination of theanine and Albizzia Julibrissin bark extract can synergistically increase the overall level of neurotransmitters through different pathways, significantly improving psychiatric symptoms such as anxiety, depression, and mood swings. Theanine provides rapid sedation and relaxation effects, while Albizzia Julibrissin bark extract stabilizes patients' emotions through long-term neuromodulatory effects. This synergistic effect is significantly better than traditional Wendan Decoction, which is difficult to achieve by simply increasing the conventional effects of Chinese medicine components.

[0107] The experimental results clearly show that the improved Chinese medicine composition (containing theanine and Albizzia Julibrissin bark extract) can significantly increase the levels of GABA, serotonin and dopamine in cells, and enhance the effects of anti-anxiety, anti-depression and mood regulation through the synergistic effects of multiple neurotransmitter pathways. This shows that the improved Chinese medicine composition can not only achieve rapid sedation and long-term mood stability, but also has innovative effects that are significantly better than traditional formulas, providing a better choice for the comprehensive treatment of patients with periodic mental illness.

[0108] Experimental Example 2: Animal Behavior Experiment Objective: To verify the improvement effect of the improved Chinese medicine composition (containing theanine and Albizzia Julibrissin bark extract) of the present invention on anxiety, depression and mood swings through animal behavior experiments, and to evaluate its innovative advantages in mood regulation.

[0109] Experimental Materials 1. Experimental animals: Wistar rats, 6-8 weeks old, weighing 180-200 g, half male and half female 2. Experimental drugs: Traditional Wendan Decoction Extract (Control Group) Improved Chinese herbal medicine composition extract (containing theanine and Albizzia julibrissin bark extract) Pure theanine, Albizzia julibrissin extract 3. Experimental equipment: Elevated Plus Maze Open Field Test Tail Suspension Test Forced Swim Test Experimental setup 1. Experimental groups: Blank control group: Rats did not receive any drugs and were only given normal saline.

[0110] Traditional Wendan Decoction group: Rats were intragastrically administered with 50 mg / kg of Traditional Wendan Decoction extract daily.

[0111] Improved Chinese medicine composition group: Rats were intragastrically administered with 50 mg / kg of the improved Chinese medicine composition extract daily.

[0112] Theanine group: Rats were intragastrically administered with 10 mg / kg of pure theanine daily.

[0113] Albizzia Julibrissin Bark Extract Group: Rats were intragastrically administered with 10 mg / kg Albizzia Julibrissin Bark Extract daily.

[0114] 2. Experimental period: The drug was administered for 14 consecutive days, with intragastric administration at a fixed time every day.

[0115] 3. Experimental Projects: Elevated plus maze test: Detect the anxiety level of rats.

[0116] Open field test: assessing the exploratory behavior and anxiety state of rats.

[0117] Tail suspension test: assessing depressive behavior in rats.

[0118] The forced swim test: assessing helplessness and depressive behavior in rats.

[0119] Experimental steps: 1. Elevated plus maze test The maze consisted of two open arms and two closed arms and was placed in the center of a brightly lit room, 50 cm above the ground.

[0120] Each rat was placed individually in the central area of ​​the maze, facing the open arm side.

[0121] The number of times the rat enters the open arms and the time it stays in the open arms are recorded within 5 minutes. More open arm activity indicates a lower level of anxiety.

[0122] 2. Open field experiment Rats were placed individually in an open field experimental box (60 cm long × 60 cm wide, divided into 16 small grids) with shields on all sides and a bright area in the center.

[0123] The number of times the rat entered the central bright area and the time it stayed there were recorded within 5 minutes. The more the rat explored the central area, the lower its anxiety level.

[0124] 3. Tail suspension test The rats were hung on a rack by their tails, 50 cm above the ground, so that their forelimbs could not touch any objects.

[0125] The time the rats were immobile (immobility time) was recorded within 6 minutes. The longer the immobility time, the more obvious the depressive behavior.

[0126] 4. Forced swimming test Place the rat in a transparent glass barrel with a water depth of 30 cm and a temperature of 25°C, making sure that the rat cannot stand and must swim.

[0127] The time the rats were immobile (immobility time) was recorded within 6 minutes. The longer the immobility time, the more obvious the depressive behavior.

[0128] The experimental data are shown in the following table: Experimental Group Elevated plus maze - open arm dwell time (seconds) Open field test - central area residence time (seconds) Tail suspension test - immobility time (seconds) Forced swimming test - immobility time (seconds) Blank control group 45 ± 5 30 ± 5 150 ± 10 180 ± 15 Traditional Wendan Decoction Group 65 ± 7 50 ± 6 120 ± 12 140 ± 10 Improved Chinese medicine combination group 105 ± 10 90 ± 8 80 ± 8 75 ± 7 Theanine group 90 ± 9 75 ± 7 100 ± 10 110 ± 10 Albizzia Julibrissin Extract Group 85 ± 8 70 ± 7 110 ± 9 105 ± 8 From the data in the above table, we can get: 1. Improvement of anxious behavior: In the elevated plus maze and open field tests, the time that rats in the modified Chinese medicine composition group stayed in the open arms and central area was significantly longer than that in other groups, especially the blank control group and the traditional Wendan Decoction group. This indicates that the modified composition significantly reduced the anxiety level of rats.

[0129] The use of theanine group and Albizzia Julibrissin bark extract group alone also showed significant antianxiety effects, but failed to reach the effect of the improved combination, indicating the enhancement of the synergistic effect of the ingredients in the combination.

[0130] 2. Improvement of depressive behavior: In the tail suspension test and forced swimming test, the immobility time of rats in the modified Chinese medicine composition group was significantly lower than that in other groups, indicating that the composition has a strong improvement effect on the depressive behavior of rats.

[0131] The individual effects of theanine group and Albizzia julibrissin extract group were also significantly better than those of the blank control group and traditional Wen Dan Tang group, but the overall effect of the combined use was better.

[0132] 3. Theanine of the present invention directly affects the balance of neurotransmitters by increasing the levels of GABA, serotonin and dopamine in the brain, promoting sedation and anti-anxiety effects. Its significant effect in animal models verifies that theanine can take effect quickly and provide relaxation and sedation effects.

[0133] The flavonoids and saponins in the Albizzia Julibrissin extract promote the synthesis and release of serotonin and dopamine through long-term regulation of the nervous system, thereby stabilizing emotions and reducing depression. The experimental results show that the Albizzia Julibrissin extract has a lasting effect in anti-depression.

[0134] The improved Chinese medicine composition significantly improves the overall therapeutic effect by combining the rapid sedative effect of theanine with the long-term mood-stabilizing effect of the Albizzia Julibrissin bark extract. The short-term sedative effect of theanine can quickly relieve anxiety, while the long-term regulatory mechanism of the Albizzia Julibrissin bark extract can maintain long-term mood stability. This combination is significantly better than the traditional Wendan Decoction group.

[0135] Through animal behavior experiments, it can be determined that the improved Chinese medicine composition of the present invention has significant anti-anxiety and anti-depression effects, especially has obvious advantages in the rapid relief of mood swings and anxiety states. Compared with traditional Chinese medicine, the synergistic effect of theanine and Albizzia Julibrissin extract in the improved composition not only enhances the therapeutic effect, but also shows significant superiority in mood stability and long-term antidepression. The experimental data and behavioral results consistently show that the improved Chinese medicine composition of the present invention provides an effective and innovative treatment for patients with periodic psychosis.

[0136] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating periodic psychosis, characterized in that: The invention comprises the following components: extracts of pinellia tuber, dried orange peel, poria cocos, immature bitter orange, bamboo shavings, licorice, ginger, jujube, theanine and julibrissin peel.

2. The Chinese medicine composition for treating periodic psychosis according to claim 1, characterized in that: The weight proportions of each component are: 10-15 parts of pinellia, 6-9 parts of tangerine peel, 9-12 parts of poria, 6-9 parts of immature bitter orange, 6-9 parts of bamboo shavings, 3-5 parts of licorice, 6-9 parts of ginger, 3-5 parts of jujube, 0.1-0.2 parts of theanine, and 0.15-0.3 parts of julibrissin bark extract.

3. The Chinese medicine composition for treating periodic psychosis according to claim 1, characterized in that: The weight proportions of the components are as follows: 12 parts of pinellia tuber, 8 parts of dried tangerine peel, 11 parts of poria, 8 parts of immature bitter orange, 8 parts of bamboo shavings, 4 parts of licorice, 8 parts of ginger, 4 parts of jujube, 0.15 parts of theanine, and 0.25 parts of julibrissin bark extract.

4. The Chinese medicine composition for treating periodic psychosis according to claim 1, characterized in that: The preparation methods of each component are as follows: Pinellia tuber, dried orange peel, Poria cocos, immature bitter orange, bamboo shavings, liquorice, ginger, jujube: take the corresponding Chinese medicinal materials, wash and dry them, grind them into coarse powder, add 10 times the amount of water and boil them twice, each time for 1-2 hours, combine the decoctions, filter and concentrate under reduced pressure to obtain Chinese medicinal extracts; Albizzia julibrissin bark extract: dry the Albizzia julibrissin bark, crush it into 20-40 mesh, use supercritical CO2 extraction, the pressure is 20-30 MPa, the temperature is 35-45°C, the extraction time is 2-3 hours, and the extract is obtained; Theanine: Use purified theanine powder and add directly to mix.

5. The Chinese medicine composition for treating periodic psychosis according to any one of claims 1 to 4, characterized in that: The Chinese medicine composition is prepared into granules or capsules for clinical use.

6. The Chinese medicine composition for treating periodic psychosis according to claim 5, characterized in that: The preparation of the Chinese medicine composition into granules for clinical use comprises the following steps: Mix the extracts of pinellia tuber, dried orange peel, poria, immature bitter orange, bamboo shavings, liquorice, ginger, jujube, Albizzia julibrissin bark extract and theanine powder evenly according to the weight ratio; Wet granulation was carried out at a temperature of 50-60°C, and the particle size was controlled at 0.3-0.5 mm; The wet granules are dried in a hot air drying oven at 60-70°C until the moisture content is less than 5%.

7. The Chinese medicine composition for treating periodic psychosis according to claim 5, characterized in that: The preparation of the Chinese medicine composition into capsules for clinical use comprises the following steps: Mix the extracts of pinellia tuber, dried orange peel, poria, immature bitter orange, bamboo shavings, liquorice, ginger, jujube, jujube bark extract and theanine powder evenly according to the formula ratio; Add microcrystalline cellulose as a filler and stir well; Carry out vacuum drying to control the moisture content below 5%; The dry mixture is put into capsules.

8. The Chinese medicine composition for treating periodic psychosis according to any one of claims 1 to 4, characterized in that: The Chinese medicine composition is prepared into tablets for clinical use.

9. The Chinese medicine composition for treating periodic psychosis according to claim 8, characterized in that: The preparation of the Chinese medicine composition into tablets for clinical use comprises the following steps: Mix the extracts of pinellia tuber, dried orange peel, poria, immature bitter orange, bamboo shavings, liquorice, ginger, jujube, jujube bark extract and theanine powder evenly according to the formula ratio; Add microcrystalline cellulose, sodium carboxymethyl starch and povidone K30 and stir well; Add appropriate amount of ethanol or purified water to moisten, make granules, and dry until the moisture content is less than 5%; Add magnesium stearate lubricant and stir evenly; The dried granules are compressed into tablets to obtain the product.

10. Use of the Chinese medicine composition for treating periodic psychosis according to any one of claims 1 to 4 in the preparation of a drug for treating periodic psychosis.