Traditional Chinese medicine composition for treating insomnia as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating insomnia and a preparation method and application thereof. The traditional Chinese medicine composition is mainly prepared from, by weight, 5-15 parts of fried spina date seeds, 3-10 parts of salvia miltiorrhiza, 1-4 parts of ligusticum wallichii, 1-4 parts of roses, 3-10 parts of poria cocos, 2-6 parts of rhizoma anemarrhenae, 0.5-3 parts of licorice roots, 3-10 parts of mulberries, 3-10 parts of lilies, 3-10 parts of lotus seeds and 3-10 parts of longan aril. The composition is high in safety, treats both symptoms and root causes according to the theory of traditional Chinese medicine, is used for treating insomnia, and can effectively improve sleep disorders such as difficulty in falling asleep, shallow sleep, easy awakening and dreaminess and relieve accompanying symptoms such as vexation and anxiety. The invention has the advantages of scientific formula, safety, reliability, no addiction, easily acceptable taste, simple preparation process and suitability for industrial production, and provides a new scheme for developing safe and effective sleep-aiding medicines or functional foods.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and specifically relates to a traditional Chinese medicine composition for treating insomnia, its preparation method, and its application. Background Technology

[0002] Insomnia is the most common sleep disorder in clinical practice, characterized by difficulty falling asleep, difficulty maintaining sleep, or early awakening, leading to impaired daytime functioning. Long-term insomnia can cause anxiety, depression, cognitive decline, and an increased risk of cardiovascular and cerebrovascular diseases. Western medicine treatment mainly uses sedative-hypnotic drugs such as benzodiazepines, but these have side effects such as dependence, tolerance, and drowsiness the following day, and are not suitable for long-term use.

[0003] Traditional Chinese medicine has a long history and unique advantages in treating insomnia, emphasizing the "holistic view" and "treatment based on syndrome differentiation". However, many existing Chinese medicine compound prescriptions for treating insomnia have the following problems: (1) They contain toxic medicinal materials (such as cinnabar, processed polygala, etc.), and the safety of long-term use is questionable; (2) The prescriptions are complex, with many medicinal ingredients (often more than 15), which makes them costly and difficult to popularize; (3) They have poor taste and low patient compliance; (4) Some prescriptions lack modern pharmacodynamic evaluation basis. Summary of the Invention

[0004] Objective of the Invention: To address the problems existing in the prior art, this invention provides a traditional Chinese medicine composition for treating insomnia, its preparation method, and its application. The traditional Chinese medicine raw materials used in this invention possess both nutritional value and pharmacological activity, exhibit high safety, and are suitable for long-term treatment. This traditional Chinese medicine composition has a simple formulation, definite efficacy, and high safety, and can effectively treat insomnia.

[0005] Technical solution: To achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0006] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating insomnia, the composition being mainly made from the following raw materials in parts by weight:

[0007] 5-15 parts stir-fried jujube seeds, 3-10 parts salvia miltiorrhiza, 1-4 parts chuanxiong rhizome, 1-4 parts rose petals, 3-10 parts poria cocos, 2-6 parts anemarrhena asphodeloides, 0.5-3 parts licorice root, 3-10 parts mulberry, 3-10 parts lily bulb, 3-10 parts lotus seeds, and 3-10 parts longan pulp.

[0008] Preferably, the traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight:

[0009] 5-15 parts stir-fried jujube seeds, 3-10 parts salvia miltiorrhiza, 1-4 parts chuanxiong rhizome, 1-4 parts rose petals, 5 parts poria cocos, 3 parts anemarrhena asphodeloides, 1 part licorice root, 5 parts mulberry, 5 parts lily bulb, 5 parts lotus seeds, and 5 parts longan pulp.

[0010] Preferably, the traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight:

[0011] 9 parts stir-fried jujube seed, 5 parts salvia miltiorrhiza, 2 parts chuanxiong rhizome, 2 parts rose petals, 3-10 parts poria cocos, 2-6 parts anemarrhena asphodeloides, 0.5-3 parts licorice root, 3-10 parts mulberry, 3-10 parts lily bulb, 3-10 parts lotus seed, and 3-10 parts longan pulp.

[0012] Preferably, the traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight:

[0013] 9 parts stir-fried jujube seeds, 5 parts salvia miltiorrhiza, 2 parts chuanxiong rhizome, 2 parts rose petals, 5 parts poria cocos, 3 parts anemarrhena asphodeloides, 1 part licorice root, 5 parts mulberry, 5 parts lily bulb, 5 parts lotus seeds, and 5 parts longan pulp.

[0014] Secondly, the present invention provides a method for preparing the aforementioned traditional Chinese medicine composition for treating insomnia, comprising the following steps:

[0015] A. Weigh out the roasted jujube seeds, salvia miltiorrhiza, chuanxiong rhizome, rose petals, poria cocos, anemarrhena rhizome, licorice root, mulberry, lily bulb, lotus seeds, and longan pulp. Grind the roasted jujube seeds into a coarse powder and mix all the raw materials together.

[0016] B. Water extraction: Add 5-10 times the total weight of the medicinal materials to the above raw materials, heat to boiling over high heat, then reduce to low heat and extract 2-4 times. After each extraction, filter out the liquid, add 5-10 times the total weight of the medicinal materials to the residue, and continue to heat and extract using the above method.

[0017] C. Combine the medicinal liquids obtained each time, and concentrate them under reduced pressure to a thick paste with a relative density of 1.3-1.6 to obtain the Chinese herbal composition.

[0018] Preferably, in step B, the active pharmaceutical ingredient is extracted by heating three times, as follows:

[0019] First extraction: Add 6-10 times the total weight of the herbs to the herbs, heat over high heat until boiling, then reduce to low heat and heat for 50-70 minutes to extract the first time;

[0020] Second extraction: Filter out the liquid, add 6-10 times the total weight of the medicinal materials to the residue, heat over high heat until boiling, then reduce to low heat and heat for 50-70 minutes to extract the second time;

[0021] Third extraction: Filter out the liquid again, add 5-8 times the total weight of the medicinal materials to the residue, heat over high heat until boiling, then reduce to low heat and heat for 50-70 minutes for the third extraction.

[0022] More preferably, in step B, the active pharmaceutical ingredient is heated and extracted three times, as follows:

[0023] First extraction: Add water to the herbs in an amount equal to 8 times their total weight, heat over high heat until boiling, then reduce to low heat and heat for 60 minutes to extract the first batch.

[0024] Second extraction: Filter out the liquid, add water equal to 8 times the total weight of the herbs to the residue, heat over high heat until boiling, then reduce to low heat and heat for 60 minutes for the second extraction;

[0025] Third extraction: Filter out the liquid again, add water equal to 6 times the total weight of the medicinal materials to the residue, heat over high heat until boiling, then reduce to low heat and heat for 60 minutes for the third extraction.

[0026] In step C, the mixture is concentrated under reduced pressure (temperature 55-75℃, vacuum degree -0.07 to -0.1 MPa) until it reaches a thick paste consistency (relative density range 1.3-1.6 (measured at 60-80℃), or determined empirically by methods such as "hanging a flag" or by ensuring the paste does not spread when dropped onto filter paper with a glass rod). This thick paste is the basic form (clear paste) of the composition of this invention.

[0027] Thirdly, the present invention provides a medicine or health food comprising the traditional Chinese medicine composition as described in the claims, wherein the traditional Chinese medicine composition is the active ingredient of the medicine or health food.

[0028] By adding appropriate pharmaceutical excipients (such as sucralose) or food additives (such as potassium sorbate) to the above-mentioned Chinese herbal composition (Qinggao), it can be made into a drug or health food for treating or assisting in the treatment of insomnia.

[0029] As a specific implementation plan, the dosage form of the drug or health food is selected from one of the following: decoction, granules, capsules, tablets, oral liquid, and decoction paste.

[0030] Fourthly, the present invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of drugs or health foods for treating insomnia.

[0031] Beneficial effects: Compared with the prior art, the present invention has the following advantages:

[0032] 1. Unique formulation and precise matching:

[0033] Chief herb: Ziziphus jujuba seed (nourishes the heart and liver, calms the mind and stops sweating) — targeting the core pathogenesis of insomnia (restlessness of mind).

[0034] Assistant herbs: Salvia miltiorrhiza (invigorates blood and removes blood stasis, clears the mind and relieves irritability), Ligusticum chuanxiong (invigorates blood and promotes qi circulation, relieves depression), rose (promotes qi circulation and relieves depression, harmonizes blood) — soothes the liver and relieves depression, invigorates blood and regulates qi and blood, and eliminates insomnia caused by "stagnation" and "blood stasis".

[0035] Adjuvant herbs: Poria cocos (strengthens the spleen and calms the mind, eliminates dampness), Anemarrhena asphodeloides (nourishes yin and reduces fire, relieves irritability), Glycyrrhiza uralensis (harmonizes the herbs, invigorates qi and replenishes the middle jiao) — strengthens the spleen and eliminates dampness, clears deficiency heat and relieves irritability, harmonizes the properties of the herbs.

[0036] The adjuvant herbs are: mulberry (nourishes yin, replenishes blood and promotes body fluid production), lily (nourishes yin, clears the heart and calms the mind), lotus seed (tonifies the spleen, nourishes the heart and kidneys), and longan pulp (tonifies the heart and spleen, nourishes blood and calms the mind)—nourishing the yin and blood of the liver, kidneys, heart and spleen, strengthening the foundation and cultivating the source, while significantly improving the taste (sweetness) and increasing patient compliance.

[0037] This formula offers a comprehensive approach: It prioritizes calming the mind and stabilizing the spirit (using jujube seed, lily bulb, lotus seed, and longan pulp); it assists in soothing the liver, relieving depression, and promoting blood circulation (using salvia miltiorrhiza, chuanxiong rhizome, and rose); it is further aided by strengthening the spleen, eliminating dampness, and relieving irritability (using poria cocos, anemarrhena rhizome, and licorice root); and it nourishes yin and blood (using mulberry). It is suitable for various common insomnia patterns, including "restlessness and insomnia," "liver stagnation and blood deficiency," "heart and spleen deficiency," and "yin deficiency with excessive fire."

[0038] 2. Mature and stable preparation process: It adopts conventional water decoction and vacuum concentration process, with clear steps and parameters, which is easy to standardize production and quality control.

[0039] 3. Significant effects (see example data): Animal experiments have confirmed that the composition of the present invention can significantly prolong the sleep time induced by sodium pentobarbital in mice and shorten the sleep latency. Behavioral experiments have shown that the composition of the present invention can improve anxiety and depression symptoms in mice. Attached Figure Description

[0040] Figure 1 This is a flowchart of the preparation process of the traditional Chinese medicine composition of the present invention.

[0041] Figure 2 This is a graph showing the changes in body weight of mice in each group during animal experiments.

[0042] Figure 3 This is a diagram showing the results of a sodium pentobarbital-induced sleep experiment in animals.

[0043] Figure 4 This is a diagram showing the results of an open field activity experiment in animal experiments.

[0044] Figure 5 This is a diagram showing the results of an elevated cross maze experiment in animal experiments.

[0045] Figure 6 The image shows the results of measuring the levels of DA and 5-HT in mouse serum during animal experiments.

[0046] Figure 7 This image shows the HE staining results of the dg region of the mouse hippocampus in an animal experiment.

[0047] Figure 8 This is a diagram showing the HE staining results of the Ca1 region of the mouse hippocampus in an animal experiment. Detailed Implementation

[0048] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0049] Example 1: Preparation of a fixed-ratio core prescription (clear paste)

[0050] Ingredients: 4788g roasted jujube seeds, 2660g salvia miltiorrhiza, 1064g chuanxiong rhizome, 1064g rose petals, 2660g poria cocos, 1596g anemarrhena asphodeloides, 532g licorice root, 2660g mulberry, 2660g lily bulb, 2660g lotus seeds, 2660g longan pulp (scaled up 532 times according to the optimal ratio), totaling 25kg.

[0051] Preparation process: 1. Weigh the above-mentioned medicinal materials, grind the jujube seed into coarse powder and mix it with other medicinal materials.

[0052] 2. First extraction: Add water equal to 8 times the total weight of the mixed herbs (approximately 200 kg of water, or 200 L), heat to boiling, then reduce to a simmer and extract for 60 minutes. Filter out the liquid (liquid 1, approximately 150 L).

[0053] Second decoction: Add 8 times the amount of water (200L) to the dregs, heat to boiling, then reduce to a simmer and extract for 60 minutes. Filter out the liquid (liquid 2, approximately 200L).

[0054] Third decoction: Add 6 times the amount of water (150L) to the dregs, heat to boiling, then reduce to a simmer and extract for 60 minutes. Filter out the liquid (liquid 3, approximately 150L).

[0055] Combined liquid: approximately 500L.

[0056] Vacuum concentration: The liquid medicine is concentrated in a vacuum concentration tank to a thick paste (temperature 70-90℃, vacuum degree -0.070~-0.080MPa). The relative density is measured to be 1.5, yielding approximately 16.6kg of clear paste (yield approximately 40%). Store in a sealed container.

[0057] Example 2: Preparation of the strip paste

[0058] Raw materials: 16.6 kg of the extract obtained in Example 1.

[0059] Process: While the paste is still hot, add 0.01% sucralose (flavoring agent) and 0.05% potassium sorbate (preservative) to the paste and stir well. Place 16.6 kg of paste into a strip-making machine and dispense it into strips of about 11 g each, producing a total of about 1000 strips.

[0060] Example 3: Animal Experimental Pharmacodynamics Study

[0061] 1. Experimental Materials and Methods

[0062] 1.1 Medicines and Reagents

[0063] In Example 2, the ingredients included ointment, diazepam, p-chlorophenylalanine (PCPA), Tween 80, 5% NaHCO3 aqueous solution, sodium pentobarbital, physiological saline, and purified water.

[0064] 1.2 Animals

[0065] Adult male SPF-grade BALB / c mice, weighing (20±2) g, were housed in the SPF-grade Animal Center of Jiangsu Provincial Hospital of Integrated Traditional and Western Medicine. They underwent acclimatization for 7 days at an ambient temperature of (23±1)℃ and relative humidity of (60±5)%. During this period, they were fed standard feed, had free access to water, and their bedding was kept dry and the environment quiet. The animal experiments were approved by the Animal Ethics Committee of Jiangsu Provincial Hospital of Integrated Traditional and Western Medicine.

[0066] 1.3 Instruments

[0067] Elevated cross maze (Shanghai Fanbi Intelligent Technology Co., Ltd.), open field test chamber (Shanghai Jiliang Software Technology Co., Ltd.), high-speed refrigerated centrifuge.

[0068] 1.4 Drug Preparation

[0069] Preparation of extract: The strip extract from Example 2 was diluted with purified water to a solution with a relative density of 1 g / ml;

[0070] Preparation of PCPA suspension: Prepare a weakly alkaline physiological saline solution with pH 7-8 using 5% NaHCO3 aqueous solution; weigh 3.5g of PCPA powder and dissolve it in the weakly alkaline physiological saline solution, add a small amount of Tween 80, sonicate for 15min, and make up to 100ml to obtain a PCPA suspension of 35mg / ml, and store it in a refrigerator at 4℃.

[0071] Diazepam solution: Dissolve diazepam tablets in physiological saline to prepare a 2.5 mg / kg solution, and store at 4°C for later use.

[0072] Sodium pentobarbital solution: Dissolve sodium pentobarbital powder in physiological saline to prepare the required concentration. The solution should be prepared and used immediately.

[0073] 1.5 Preliminary Experiment

[0074] In the preliminary experiment, mice were randomly divided into 3 groups of 10 each, and injected with sodium pentobarbital at doses of 50 mg / kg, 55 mg / kg, and 60 mg / kg, respectively. The final dose of sodium pentobarbital was determined to ensure that 100% of the mice fell asleep without causing excessive sleep time.

[0075] 2. Experimental Methods

[0076] 2.1 Animal grouping, model preparation, and drug administration

[0077] Mice were randomly divided into 6 groups of 6 mice each: a control group, a model group, a positive control group, a low (10-fold) dose group, a medium (20-fold) dose group, and a high (30-fold) dose group. Except for the control group, all mice were subjected to unpredictable stressors including: tail clamping (5 minutes), swimming in cold water (4°C water, 5 minutes), food deprivation (24 hours), dehydration (24 hours), wet sawdust bedding (24 hours), cage tilting at 45° (24 hours), limb restraint (2 hours), and horizontal shaking (5 minutes). Mice were exposed to 1-2 of these stressors daily for 14 days, with no use of the same stressor for two consecutive days. Each group of mice was then injected intraperitoneally with PCPA (350 mg / ml) suspension once daily for 3 days to establish a mouse model of insomnia. After modeling, the mice's behavior was observed. Successful modeling was indicated by abnormal mental state, rough fur, dull coat, irritability, cloudy urine, and slow weight gain in the model group. After successful modeling, mice in the control group and model group were administered pure water by gavage daily, while other groups were administered the corresponding drugs by gavage.

[0078] 2.2 Observation of the physiological condition of mice

[0079] After the experiment began, the mice were weighed every 3 days to observe their activity, fur, mental state, etc.

[0080] 2.3 Sodium pentobarbital-assisted sleep experiment

[0081] One day before the end of the experiment, 30 minutes after administration, each group of mice was intraperitoneally injected with sodium pentobarbital at a dose of 55 mg / kg, as determined in the preliminary experiment. The sleep latency (the time from the injection of sodium pentobarbital to the disappearance of the righting reflex) and sleep duration (the time from the disappearance of the righting reflex to awakening) were observed. The disappearance of the righting reflex was defined as the mouse remaining in a supine position for up to 60 seconds without being able to right itself.

[0082] 2.4 Open Field Experiment (OFT)

[0083] Two days before the end of the experiment, 30 minutes after drug administration, mice underwent Off-The-Field (OFT) treatment. The mice were placed in the center of a reaction chamber measuring 40cm x 40cm with 50cm high side walls. The interior of the chamber was blue, and the bottom area was divided into 16 chambers. After acclimatizing in the chambers for 1 minute, the activities of each group of mice were recorded over 5 minutes. The total distance traveled within the chamber, average speed, percentage of distance traveled into the central area, and percentage of time spent in the central area were used as evaluation indicators. The experiment was conducted in a quiet environment with stable lighting. After each mouse's experiment, the inner walls and bottom of the chamber were wiped with 75% ethanol to prevent the retention of odors and excrement.

[0084] 2.5 Cross Maze Experiment (EPM)

[0085] Three days before the end of the experiment, mice underwent EPM (Extended Particulate Detection) 30 minutes after drug administration. The EPM consisted of two open arms and two closed arms, each 30 cm long, with a central area of ​​a 7 cm × 7 cm square grid and a height of 50 cm. During the experiment, the mice were removed, gently placed face-up in the central area with the open arms facing out, and the animal behavior analysis software Tracking Master was used to track the mice's movements over 5 minutes, recording the number of times and the time spent entering the open arms. Percentage of time spent in open arms = (Total time spent in open arms / (Total time spent in open arms + Total time spent in closed arms) × 100%; Percentage of number of times a mouse entered an open arm = (Number of times a mouse entered an open arm / (Number of times a mouse entered an open arm + Number of times a mouse entered a closed arm) × 100%.

[0086] 2.6 Determination of DA and 5-HE levels in peripheral serum

[0087] Twelve hours after the last administration, all mice were fasted for 12 hours, and peripheral blood serum was collected by blood sampling from the eyeballs. The levels of DA and 5-HT in the serum were measured according to the ELISA kit instructions.

[0088] 2.7 HE staining of hippocampal sections

[0089] After blood collection, the mice were placed on ice to remove their brains. The hemibrain was fixed in 4% paraformaldehyde solution and stored at room temperature. The fixed hemibrain tissue was then routinely embedded in paraffin, sectioned, dewaxed, rehydrated with graded ethanol, stained with hematoxylin-eosin, dehydrated, and mounted with neutral resin. The pathological changes of hippocampal cells were observed under a light microscope.

[0090] 3. Experimental Results

[0091] 3.1 Physiological condition of mice

[0092] During the modeling period, the model group mice exhibited abnormal mental state, rough fur, dull coat color, irritability, cloudy urine, and slow weight gain; Figure 2It was found that during the administration period, compared with the blank group mice, the model group mice had a persistently abnormal mental state, persistently dark and rough fur, and slow weight gain (P<0.001); compared with the model group, the positive drug group and the mice given low, medium and high concentrations of the traditional Chinese medicine composition had gradually improved mental state, their fur gradually became soft and smooth, and their weight gradually increased (P<0.001).

[0093] 3.2 Sodium pentobarbital-assisted sleep experiment

[0094] Depend on Figure 3 It was found that, compared with the blank control group, the sleep latency of the model group mice was significantly prolonged (P<0.0001) and the sleep time was significantly shortened (P<0.005), indicating that the model group mice had sleep disorders. Compared with the model group mice, the sleep latency of the diazepam positive drug group and the high, medium and low concentration groups of the traditional Chinese medicine composition were significantly shortened, and the difference was statistically significant (P<0.0001). Compared with the model group mice, the sleep time of the diazepam positive drug group and the high, medium and low concentration groups of the traditional Chinese medicine composition were significantly prolonged, and the difference was statistically significant (P<0.05).

[0095] 3.3 Open Field Experiment (OFT)

[0096] Depend on Figure 4 As can be seen from this OFT experiment, in Figure A, the total spontaneous activity distance of the model group mice was less than that of the control group. The activity distance of the positive drug group and the low, medium, and high concentration groups of the traditional Chinese medicine composition were all greater than that of the model group, but there was no significant difference. In Figure B, the activity speed of the model group mice was lower than that of the other groups, but no significant difference was observed outside the positive drug group. In Figure C, compared with the control group mice, the proportion of activity distance in the central region of the model group mice was significantly reduced (P < 0.005). Compared with the model group mice, the proportion of activity distance in the central region of the diazepam group and the low, medium, and high concentration groups of the traditional Chinese medicine composition was significantly higher than that of the model group mice (P < 0.01). In Figure D, compared with the control group mice, the proportion of activity time in the central region of the model group mice was significantly reduced (P < 0.01). Compared with the model group mice, the proportion of activity time in the central region of the diazepam group and the low, medium, and high concentration groups of the traditional Chinese medicine composition was significantly higher than that of the model group mice (P < 0.01). The OFT results above indicate that the model group mice exhibited symptoms of depression and anxiety. These symptoms were alleviated after administration of the drug, suggesting that this traditional Chinese medicine composition can improve the symptoms of depression and anxiety in mice caused by insomnia.

[0097] 3.4 Elevated Cross Maze Experiment (EPM)

[0098] Depend on Figure 5As shown in Figure A, compared with the control group, the proportion of time spent entering the open arm in the model group was significantly lower (P < 0.05). Compared with the model group, the proportion of time spent entering the open arm in the positive control group and the low, medium, and high concentration groups of the traditional Chinese medicine composition was significantly higher, and all differences were statistically significant except for the low concentration group (P < 0.005). In Figure B, compared with the control group, the proportion of times the model group mice entered the open arm was significantly lower (P < 0.0005). Compared with the model group, the proportion of time spent entering the open arm in the positive control group and the low, medium, and high concentration groups of the traditional Chinese medicine composition was significantly higher, and all differences were statistically significant (P < 0.05). These EMP results indicate that the model group mice exhibited obvious anxiety symptoms, which were alleviated after administration, suggesting that this traditional Chinese medicine composition can improve the anxiety and tension in insomniac mice.

[0099] 3.5 Peripheral serum DA and 5-HE content

[0100] Depend on Figure 6 As shown in Figure A, compared with the control group, the serum DA content in the model group mice was significantly reduced (P < 0.0001), and compared with the model group, the DA content in the treatment group was significantly higher than that in the model group mice (P < 0.005). In Figure B, the serum DA content in the model group mice was significantly reduced (P < 0.0001), and compared with the model group, the DA content in the treatment group was significantly higher than that in the model group mice (P < 0.001). These results indicate that the reduced DA and 5-HT levels in the model group mice suggest that the insomnia model caused dysfunction of the monoamine neurotransmitter system in mice. The increased levels after drug administration indicate that this traditional Chinese medicine composition can effectively reverse this disordered state.

[0101] 3.6 HE staining of the hippocampus

[0102] Depend on Figure 7 It was found that in the dg region of the hippocampus of mice, compared with the blank group, the model group mice had more dead cells, and the cells were loosely and irregularly arranged. The drug-treated group mice had tightly arranged cells, clear cell membrane edges, and a significantly reduced number of dead cells. Figure 8 It was found that, compared with the control group, the model group mice had loose and irregular cell arrangement, blurred cell membrane edges, and a higher number of dead cells in the CA1 region of the hippocampus. The drug-treated group mice had significantly tighter and more regular cell arrangement, and fewer dead cells than the model group. The results suggest that the cells in the DG and CA1 regions of the hippocampus of the insomnia model mice were damaged, and the symptoms improved after drug administration.

[0103] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition for treating insomnia, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 5-15 parts stir-fried jujube seeds, 3-10 parts salvia miltiorrhiza, 1-4 parts chuanxiong rhizome, 1-4 parts rose petals, 3-10 parts poria cocos, 2-6 parts anemarrhena asphodeloides, 0.5-3 parts licorice root, 3-10 parts mulberry, 3-10 parts lily bulb, 3-10 parts lotus seeds, and 3-10 parts longan pulp.

2. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 5-15 parts stir-fried jujube seeds, 3-10 parts salvia miltiorrhiza, 1-4 parts chuanxiong rhizome, 1-4 parts rose petals, 5 parts poria cocos, 3 parts anemarrhena asphodeloides, 1 part licorice root, 5 parts mulberry, 5 parts lily bulb, 5 parts lotus seeds, and 5 parts longan pulp.

3. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 9 parts stir-fried jujube seed, 5 parts salvia miltiorrhiza, 2 parts chuanxiong rhizome, 2 parts rose petals, 3-10 parts poria cocos, 2-6 parts anemarrhena asphodeloides, 0.5-3 parts licorice root, 3-10 parts mulberry, 3-10 parts lily bulb, 3-10 parts lotus seed, and 3-10 parts longan pulp.

4. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that, The traditional Chinese medicine composition is mainly made from the following raw materials in parts by weight: 9 parts stir-fried jujube seeds, 5 parts salvia miltiorrhiza, 2 parts chuanxiong rhizome, 2 parts rose petals, 5 parts poria cocos, 3 parts anemarrhena asphodeloides, 1 part licorice root, 5 parts mulberry, 5 parts lily bulb, 5 parts lotus seeds, and 5 parts longan pulp.

5. A method for preparing the traditional Chinese medicine composition for treating insomnia according to any one of claims 1-4, characterized in that, Includes the following steps: A. Weigh out the roasted jujube seeds, salvia miltiorrhiza, chuanxiong rhizome, rose petals, poria cocos, anemarrhena rhizome, licorice root, mulberry, lily bulb, lotus seeds, and longan pulp. Grind the roasted jujube seeds into a coarse powder and mix all the raw materials together. B. Water extraction: Add 5-10 times the total weight of the medicinal materials to the above raw materials, heat to boiling over high heat, then reduce to low heat and extract 2-4 times. After each extraction, filter out the liquid, add 5-10 times the total weight of the medicinal materials to the residue, and continue to heat and extract using the above method. C. Combine the medicinal liquids obtained each time, and concentrate them under reduced pressure to a thick paste with a relative density of 1.3-1.6 to obtain the Chinese herbal composition.

6. The method for preparing the traditional Chinese medicine composition for treating insomnia according to claim 5, characterized in that, In step B, the raw material is extracted by heating three times, as follows: First extraction: Add 6-10 times the total weight of the herbs to the herbs, heat over high heat until boiling, then reduce to low heat and heat for 50-70 minutes to extract the first time; Second extraction: Filter out the liquid, add 6-10 times the total weight of the medicinal materials to the residue, heat over high heat until boiling, then reduce to low heat and heat for 50-70 minutes to extract the second time; Third extraction: Filter out the liquid again, add 5-8 times the total weight of the medicinal materials to the residue, heat over high heat until boiling, then reduce to low heat and heat for 50-70 minutes for the third extraction.

7. The method for preparing the traditional Chinese medicine composition for treating insomnia according to claim 5, characterized in that, In step B, the raw material is extracted by heating three times, as follows: First extraction: Add water to the herbs in an amount equal to 8 times their total weight, heat over high heat until boiling, then reduce to low heat and heat for 60 minutes to extract the first batch. Second extraction: Filter out the liquid, add water equal to 8 times the total weight of the herbs to the residue, heat over high heat until boiling, then reduce to low heat and heat for 60 minutes for the second extraction; Third extraction: Filter out the liquid again, add water equal to 6 times the total weight of the medicinal materials to the residue, heat over high heat until boiling, then reduce to low heat and heat for 60 minutes for the third extraction.

8. A drug or health food, characterized in that, The traditional Chinese medicine composition comprises any one of claims 1 to 4, wherein the traditional Chinese medicine composition is the active ingredient of the drug or health food.

9. The drug or health food according to claim 6, characterized in that, The dosage form of the drug or health food is selected from one of the following: decoction, granules, capsules, tablets, oral liquid, or paste.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicine or health food for treating insomnia.

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