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 as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 12-17 parts of spica prunellae, 7-11 parts of rhizoma acori graminei, 4-8 parts of herba cepbalanoplosis segeti, 7-13 parts of semen boitae and 4-8 parts of caulis bambusae in taeniam. The traditional Chinese medicine composition is prepared from five specific traditional Chinese medicines, namely selfheal serving as a monarch, rhizoma acori graminei and herba cepbalanoplosis segeti serving as ministers and semen boitae and caulis bambusae in taeniam serving as assistants and guides, and the selfheal with the effect of clearing away liver fire, the rhizoma acori graminei with the effects of inducing resuscitation, eliminating phlegm, inducing resuscitation and benefiting intelligence, the herba cepbalanoplosis segeti and the semen boitae with the effects of strengthening clearing away liver fire and tranquilizing mind by nourishing the heart and the sweet and cold caulis bambusae in taeniam are combined and preparing the traditional Chinese medicine preparation for treating insomnia. The traditional Chinese medicine composition has the effects of soothing the liver, discharging heat, relieving restlessness and soothing the nerves, has a remarkable curative effect on sleep dysfunction caused by hyperactivity of liver fire and yin deficiency of phlegm-heat, and can help patients to relieve insomnia symptoms and improve sleep quality through endogenous treatment.

Description

Technical Field

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

[0002] Insomnia is very common in clinical practice. Having a good sleep is the basic guarantee for the normal operation of various necessary physiological functions such as maintaining immunity, protecting the brain, repairing the body, replenishing physical strength, and relieving fatigue. Insomnia can lead to cognitive impairment, depression, obesity, reproductive dysfunction, and a series of cardiovascular and cerebrovascular diseases.

[0003] Although the western medicine currently used to treat insomnia has a definite sedative and hypnotic effect, it often shows many side effects after taking it, and is prone to addiction and tolerance. Traditional Chinese medicine has a long history in treating insomnia, with reliable clinical efficacy and good safety. With the increasing demand for insomnia treatment, the development of Chinese patent medicines with more definite clinical effects and clearer mechanisms of action has important clinical value and market demand.

[0004] According to TCM theory, sleep itself is a process of transition from yang to yin, from movement to stillness, from opening to closing, so it needs to be restrained and calm. From the perspective of TCM, the causes of insomnia may be caused by liver depression and qi stagnation, phlegm-fire disturbing the heart, yin deficiency and hyperactivity of fire, deficiency of both heart and spleen, and disharmony between heart and kidney. Modern people live at a faster pace, with problems such as high work pressure and uncontrolled eating and drinking. Coupled with factors such as climate, it is easy to produce heat syndrome. Heat is a yang evil, which is easy to dissipate and agitate. Therefore, fire in the body is most likely to consume the heart and mind and cause insomnia, which in turn leads to insomnia due to excess syndrome. At present, the traditional Chinese medicine insomnia preparations produced by pharmaceutical factories are mostly aimed at patients with insomnia due to deficiency syndrome, mainly focusing on nourishing the heart and calming the mind, replenishing qi and tonifying the kidney (such as sour jujube seed paste, Wuling capsule, Bailemian capsule, Liuwei Anshen capsule, etc.). According to the clinical experience of Professor Wang Qingguo, a master of traditional Chinese medicine, more than one-third of insomnia patients suffer from the two excess syndromes of liver depression and internal disturbance of phlegm and heat, but there is still a lack of effective and fast-acting traditional Chinese medicine preparations for insomnia due to excess syndrome on the market. Summary of the invention

[0005] In order to overcome the problems existing in the above-mentioned prior art, one of the purposes of the present invention is to provide a Chinese medicine composition. The second purpose of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition. The third purpose of the present invention is to provide an application of the Chinese medicine composition.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is:

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition, which is prepared by comprising the following raw materials in parts by weight: 12-17 parts of Prunella Vulgaris, 7-11 parts of Acorus calamus, 4-8 parts of Cirsium japonicum, 7-13 parts of Platycladus orientalis seeds, and 4-8 parts of Bambusa shavings.

[0008] The present invention is based on the theories of traditional Chinese medicine of "replenishing the deficiency and purging the excess" and "treating the disease must seek the root cause", and cleverly uses the complementarity of different medicines to target the cause of the disease from multiple aspects, and adopts the law of "spicy, sweet, bitter and cold". The herb Prunella vulgaris with the effect of clearing and purging liver fire, the herb Acorus calamus with the effects of opening the orifices, resolving phlegm, refreshing the mind and improving intelligence, and other Chinese medicines that can enhance the effects of clearing and purging liver fire and nourishing the heart and calming the mind are added with the sweet and cold bamboo shavings to make a Chinese medicine preparation for treating insomnia.

[0009] In the Chinese medicine prescription of the present invention, Prunella vulgaris is the monarch, Acorus calamus and Thistle are the ministers, and Platycladus orientalis and Rhizoma Anemarrhenae are the assistants. Prunella vulgaris is the monarch, clearing away liver fire and nourishing liver blood; Acorus calamus is the assistant, calming the mind and improving intelligence; Thistle is the assistant, cooling blood and removing blood stasis; Platycladus orientalis is the assistant, calming the mind and tranquilizing the nerves; Rhizoma Anemarrhenae is the assistant, clearing away heat and removing phlegm, calming the mind and relieving depression, and harmonizing various medicines.

[0010] Prunella vulgaris: pungent, bitter, and cold, it can clear the liver and reduce fire, improve eyesight, disperse stagnation and reduce swelling. It is the dried fruit spike of the Lamiaceae plant Prunella vulgaris (scientific name: Prunella vulgaris L.).

[0011] Acrorus tatarinowii Schott: pungent, bitter, warm, it can open up the orifices and eliminate phlegm, wake up the mind and improve intelligence, eliminate dampness and stimulate the appetite. It is the dried rhizome of Acrorus tatarinowii Schott (scientific name: Acrorus tatarinowii Schott), a plant of the Araceae family.

[0012] Cirsium setosum: sweet, bitter, cool, cools blood and stops bleeding, disperses blood stasis, detoxifies and eliminates carbuncle. It is the dried aerial part of the Asteraceae plant Cirsium setosum (scientific name: Cirsium setosum (Willd.) MB.).

[0013] Platycladus orientalis (L.) Franco, a plant of the Cupressaceae family, is a dried mature seed of the Platycladus orientalis (L.) Franco.

[0014] Bamboo Rhus: sweet, slightly cold, clears away heat and resolves phlegm, relieves restlessness and stops vomiting. It is the dried middle layer of the stems of the Poaceae plants Bambusatuldoides Munro (scientific name: Bambusatuldoides Munro), Sinocalamus beecheyanus (Munro) McClurevar. Pubescens PFLi or Phyllostachys nigra (Lodd.) Munro var. henonis (Mitf.) Stapf ex Rendle.

[0015] Preferably, the active ingredient is prepared from the following raw materials in parts by mass: 13-16 parts of Prunella Vulgaris, 8-10 parts of Acorus calamus, 5-7 parts of Cirsium cyrtonema, 8-12 parts of Platycladus orientalis seeds, and 5-7 parts of Bambusa shavings.

[0016] Preferably, a pharmaceutically acceptable excipient is also included.

[0017] For those skilled in the art, the above-mentioned pharmaceutically acceptable pharmaceutical excipients are used to improve drug stability or give the drug an appropriate dosage form for transportation, carrying, storage or administration, such as surfactants, lubricants, preservatives, etc. The types of pharmaceutically acceptable pharmaceutical excipients, as well as the selection criteria and selection methods are well known to those skilled in the art. Through design methods such as orthogonal experiments, those skilled in the art do not need creative labor and can select suitable pharmaceutical excipients and their proportions and preparation processes through limited experiments. For pharmaceutically acceptable pharmaceutical excipients for Chinese medicine compound prescriptions, see Cui Lide's "Pharmaceutics" (Beijing: People's Medical Publishing House, published in 2007), Zhang Zhaowang's "Chinese Medicine Pharmacy" (Beijing: China Traditional Chinese Medicine Press, published in 2007), etc. For Chinese medicine oral granules, commonly used pharmaceutical excipients include starch, lactose, micropowder silica gel, microcrystalline cellulose, etc., and their uses and usage in preparations are well known to those skilled in the art, and their dosage is that those skilled in the art do not need creative labor and can directly obtain it through limited experiments.

[0018] Preferably, the dosage form of the Chinese medicine composition is an oral preparation or a transdermal absorbent; wherein the oral preparation is selected from granules, powders, tablets, pills, oral liquids or capsules.

[0019] More preferably, the dosage form of the Chinese medicine composition is a granule, specifically a Chinese medicine solid granule, which is obtained by mixing and granulating the following raw materials: Acorus calamus volatile oil, Platycladus chinensis volatile oil, dry extract, and other preparation excipients; the dry extract is prepared from Acorus calamus residue, Platycladus chinensis residue, Prunella vulgaris, Thistle and Bamboo Shavings.

[0020] Further preferably, the Acorus calamus volatile oil and Semen Platycladi volatile oil are included in the inclusion complex prepared by using β-cyclodextrin.

[0021] The second aspect of the present invention provides a method for preparing the Chinese medicine composition according to the first aspect, comprising the following steps:

[0022] S1. Extracting volatile oil from Acorus calamus and Semen Platycladi by steam distillation to obtain volatile oil, medicinal residues and medicinal solution;

[0023] S2, combining the medicinal residues with Prunella vulgaris, Thistle and Bamboo Shavings to perform water extraction and / or alcohol extraction 1, and then combining the medicinal solution and the extract to concentrate to obtain an extract; the number of water extractions is single or multiple;

[0024] S3, combining the volatile oil and the extract to obtain the Chinese medicine composition;

[0025] Alternatively, the method comprises the following steps: combining the raw materials and performing single or multiple alcohol extractions 2 to obtain the traditional Chinese medicine composition.

[0026] The volatile oil contained in the medicinal material of Acorus calamus has a certain central nervous system inhibitory effect, and the volatile oil of the cypress seed has the effect of nourishing the heart and calming the mind, and has a good effect on insomnia. The water extracts of the two also have ingredients with hypnotic effect. Therefore, in the preparation process of the present invention, the volatile oil of Acorus calamus and the cypress seed is first extracted, the residue is mixed with other raw materials, boiled in water, the water-soluble effective ingredients are extracted, and the water-soluble effective ingredients are combined to prepare the traditional Chinese medicine composition.

[0027] Preferably, the mass ratio of the amount of water used in the steam distillation to the sum of the Acorus calamus and the Semen Platycladi is (15-20):1.

[0028] Preferably, the steam distillation time is 5-7h.

[0029] Preferably, the mass ratio of the amount of water used in the water extraction to the sum of the medicinal residues and other raw materials is (15-25):1.

[0030] Preferably, the water extraction time is 1-2 hours.

[0031] Preferably, the water extraction temperature is 90-100°C.

[0032] Preferably, the water extraction is performed 2-3 times.

[0033] More preferably, step S2 is: combining the medicinal residue with Prunella vulgaris, Thistle and Rhizoma Anemarrhenae to perform water extraction 2-3 times, and then combining the medicinal solution and the extract to concentrate to obtain an extract.

[0034] Preferably, the method further comprises the following steps: preparing the volatile oil into an inclusion compound, and then combining the inclusion compound with the extract.

[0035] More preferably, the preparation method of the inclusion compound is: using a saturated aqueous solution method to carry out β-cyclodextrin inclusion of volatile oil.

[0036] Preferably, the concentration is to concentrate the combined solution of the drug solution and the water extract to a relative density of 1.10-1.15.

[0037] Preferably, step S2 further comprises: combining the medicinal solution and the extract to concentrate, and performing alcohol precipitation to obtain an extract.

[0038] More preferably, the alcohol precipitation is performed by adding ethanol dropwise to the concentrated solution obtained by concentration until the alcohol content reaches 60%-80%.

[0039] Preferably, the mass ratio of the amount of alcohol used in the alcohol extraction 2 to the sum of the medicinal residues and other raw materials is (15-25):1;

[0040] Preferably, the alcohol extraction 2 is carried out for 1-2 hours.

[0041] Preferably, the temperature of the alcohol extraction 2 is 70-80°C.

[0042] Preferably, the alcohol extraction 2 is performed 2-3 times.

[0043] Preferably, the alcohol extraction 2 uses an ethanol aqueous solution with a concentration of 40%-60%.

[0044] The third aspect of the present invention provides use of the Chinese medicine composition described in the first aspect in preparing a medicine for treating insomnia.

[0045] Preferably, the insomnia is an insomnia disorder characterized by liver depression transforming into fire and / or phlegm-fire disturbing the heart according to TCM syndrome differentiation.

[0046] The beneficial effects of the present invention are:

[0047] The invention provides a Chinese medicine composition, which is composed of five specific Chinese medicines, with Prunella vulgaris as the main ingredient, Acorus calamus and Thistle as the subordinate ingredients, and Platycladus orientalis and Rhizoma Anemarrhenae as the adjuvants, and Prunella vulgaris with the effect of clearing liver fire, Acorus calamus with the effects of opening the mind and removing phlegm, refreshing the mind and improving intelligence, and other Thistle orientalis and Platycladus orientalis that strengthen clearing liver fire and nourishing the heart and calming the mind, and Rhizoma Anemarrhenae with the effects of sweet and cold, are prepared into a Chinese medicine preparation for treating insomnia. The Chinese medicine composition of the invention has the functions of soothing the liver and venting heat, eliminating restlessness and calming the mind, has a significant therapeutic effect on sleep dysfunction caused by hyperactivity of liver fire and phlegm-heat and yin deficiency, and can help patients relieve insomnia symptoms and improve sleep quality through endogenous treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 The following is a process flow of the preparation method of the Chinese medicine granules of Example 1;

[0049] Figure 2 The results of the sleep experiment induced by sodium pentobarbital; (a) is the result of the sleep latency experiment, and (b) is the result of the sleep duration experiment;

[0050] Figure 3 The results of repeated synergistic sodium pentobarbital-induced sleep experiments; (a) is the result of the sleep latency experiment, and (b) is the result of the sleep duration experiment;

[0051] Figure 2 and Figure 3 Compared with the blank group, *P<0.05, **P<0.01, *P<0.001, n=10. DETAILED DESCRIPTION

[0052] The present invention is further described in detail below through specific examples. The raw materials used in the following examples, unless otherwise specified, can be obtained from conventional commercial sources or prepared and separated by simple synthesis; the processes used, unless otherwise specified, are conventional processes in the art.

[0053] Example 1

[0054] This embodiment provides a Chinese medicine granule (solid granule), the weight ratio of the effective ingredients of Chinese medicine is: 15 parts of Prunella Vulgaris, 9 parts of Acorus Calamus, 6 parts of Cirsium cyrtonema, 10 parts of Platycladus orientalis, and 6 parts of Rhizoma Anemarrhenae. Figure 1 The preparation method of the Chinese medicine granules of Example 1 is as follows:

[0055] S1, taking Acorus calamus and Semen Platycladi, extracting volatile oil by steam distillation, the mass ratio of water used for steam distillation to the sum of Acorus calamus and Semen Platycladi is 16:1, the time of steam distillation is 6h, and the obtained medicinal solution 1, medicinal residue and volatile oil are respectively stored for standby use;

[0056] S2, mix Prunella vulgaris, thistle, bamboo shavings and the residue, add 18 times the amount of deionized water, soak for 1 hour, heat at 100℃ and reflux for 1.5 hours, filter, and obtain filtrate 2; add 18 times the amount of deionized water again, heat at 100℃ and reflux for 1.5 hours, filter, and obtain filtrate 3, combine the medicinal solution 1, filtrate 2, and filtrate 3, and concentrate the medicinal solution to a relative density of 1.10-1.15. Add ethanol to the above concentrated solution until the alcohol content reaches 70%, let it stand for a certain period of time, centrifuge, take the supernatant, recover the solvent, and reduce the pressure to dry to obtain a dry extract for standby use.

[0057] S3. Add appropriate amount of β-cyclodextrin to embed the volatile oils of Acorus calamus and Platycladus orientalis, prepare saturated aqueous solution with β-cyclodextrin, dissolve the volatile oil in 95% ethanol in a weight ratio, add the volatile oil to the saturated aqueous solution at a ratio of volatile oil: β-cyclodextrin = 1:8, stir at 50°C for 2 hours at a stirring speed of 800 rpm, let stand at 4°C for 24 hours, filter, wash the filter layer with appropriate amount of water and petroleum ether respectively, evaporate the petroleum ether, dry in a vacuum drying oven at 40°C for 4 hours to prepare an inclusion compound, and then mix evenly with the above-mentioned Chinese medicine dry extract, add appropriate amount of dextrin, granulate, dry, and package to obtain a Chinese medicine granule product.

[0058] Example 2

[0059] This embodiment provides a Chinese medicine granule (solid granule), the weight ratio of the effective ingredients of Chinese medicine is: 15 parts of Prunella Vulgaris, 9 parts of Acorus Calamus, 6 parts of Cirsium cyrtonema, 10 parts of Platycladus orientalis, and 6 parts of Rhizoma Anemarrhenae. The specific preparation steps are as follows:

[0060] S1, taking Acorus calamus and Platycladus orientalis, extracting volatile oil by steam distillation, the mass ratio of water used for steam distillation to the sum of Acorus calamus and Platycladus orientalis is 16:1, the time of steam distillation is 6h, and the medicinal solution 1, the medicinal residue and the volatile oil are separately stored for standby use;

[0061] S2. Mix the herbaceous earth, thistle, bamboo shavings and the residues, add 20 times the amount of 50% ethanol (2200 ml), heat to 80°C for reflux extraction for 1.5 hours, filter to obtain filtrate 2; add 18 times the amount of deionized water, heat to 80°C for reflux extraction for 1.5 hours, filter to obtain filtrate 3, combine the medicinal solution 1, filtrate 2 and filtrate 3, concentrate the medicinal solution to a relative density of 1.10-1.15, recover the solvent, dry under reduced pressure to obtain a dry extract for later use.

[0062] S3. Add appropriate amount of β-cyclodextrin to the volatile oils of Acorus calamus and Semen Platycladi for embedding in the same manner as in Example 1, and then mix them evenly with the above-mentioned Chinese medicine dry extract, add appropriate amount of dextrin, granulate, dry, and package to obtain a Chinese medicine granule product.

[0063] Example 3

[0064] This embodiment provides a Chinese medicine composition (i.e., Chinese medicine extract), the Chinese medicine weight ratio of the effective ingredients is: 15 parts of Prunella Vulgaris, 9 parts of Acorus Calamus, 6 parts of Cirsium cyrtonema, 10 parts of Platycladus orientalis, and 6 parts of Rhizoma Anemarrhenae, and the preparation steps are as follows:

[0065] Take Prunella Vulgaris, Acorus calamus, Thistle, Platycladus orientalis, and Rhizoma Anemarrhenae, put them in a 5000ml round-bottom flask, add 20 times the amount of 50% ethanol (2200ml), reflux extraction twice at 80°C, each time for 1.5h, filter, combine the filtrate, concentrate the medicinal solution to a relative density of 1.10-1.15, recover the solvent, dry under reduced pressure to obtain a dry extract, add an appropriate amount of dextrin, granulate, dry, and package to obtain a Chinese medicine granule product.

[0066] Experimental analysis

[0067] The pentobarbital-induced sleep experiment in mice is a widely recognized behavioral method for evaluating the sedative and hypnotic effects of drugs. This experiment used a suprathreshold dose of sodium pentobarbital to synergize the sleep experiment to observe the latency to sleep and the duration of sleep. The animals fell asleep based on the disappearance of the righting reflex. After the drug was administered, when the animals basically stopped moving, their positions were turned over, that is, in a supine position. If the animals lay in a supine position for more than 60 seconds, it was judged that their righting reflex disappeared and they entered a sleep state. After a period of time, when the righting reflex was restored for the first time, it was immediately turned over to a supine position. If it was restored again within 30 seconds, the animal was judged to be awake, and the time of the first restoration of the righting reflex was recorded as the end of sleep.

[0068] The team used the classic method of synergistic sodium pentobarbital-induced sleep experiment (PIST) to verify the sedative and hypnotic efficacy of the compound. Based on the previous research results, the suprathreshold dose of sodium pentobarbital in ICR mice was determined to be 50 mg / kg, and this experiment continued to use this dose. The dosage was based on 55g of Prunella Vulgaris compound per day for an adult weighing 70kg, and the actual dosage of mice was converted to 0.86g / kg. 50 male ICR mice (8 weeks old, 20-25g, SPF level) were randomly divided into 5 groups, namely blank group, diazepam group, water extraction group, alcohol extraction group and oil group, with 10 mice in each group, of which the oil group was Example 1, the water extraction group was Example 2, and the alcohol extraction group was Example 3. Pharmacodynamic studies were carried out with sleep latency and sleep duration as investigation indicators. Figure 2 and 3 The results of two repeated experiments showed that the preparations of Examples 1-3 had good pharmacological effects in inducing sleep in animals in cooperation with sodium pentobarbital, and could effectively shorten the time it took for mice to fall asleep and increase the length of their sleep, and the effect of the preparation of Example 1 was more significant.

[0069] The product of the present invention is safe. The acute toxicity or maximum tolerated dose experiment was conducted using the granules in Example 1. Twelve male mice were gavaged with the maximum tested concentration (6.88 g / kg) and the maximum tested volume. The maximum tolerated dose was equivalent to 8 times the clinical dosage, and no obvious abnormal reactions or gross pathological changes were observed.

[0070] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be equivalent replacement methods and are included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The invention comprises the following raw materials in parts by weight: 12-17 parts of selfheal, 7-11 parts of calamus, 4-8 parts of thistle, 7-13 parts of cypress seeds and 4-8 parts of bamboo shavings.

2. The Chinese medicine composition according to claim 1, characterized in that: Pharmaceutically acceptable excipients are also included.

3. The Chinese medicine composition according to claim 1, characterized in that The dosage form of the Chinese medicine composition is an oral preparation or a transdermal absorbent; wherein the oral preparation is selected from granules, powders, tablets, pills, oral liquids or capsules.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The steps include: S1. Extracting volatile oil from Acorus calamus and Semen Platycladi by steam distillation to obtain volatile oil, medicinal residues and medicinal solution; S2, combining the medicinal residues with Prunella vulgaris, Thistle and Bamboo Shavings to perform water extraction and / or alcohol extraction 1, and then combining the medicinal solution and the extract to concentrate to obtain an extract; the number of water extractions is single or multiple; S3, combining the volatile oil and the extract to obtain the Chinese medicine composition; Alternatively, the method comprises the following steps: combining the raw materials and performing single or multiple alcohol extractions 2 to obtain the traditional Chinese medicine composition.

5. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The mass ratio of the water used in the steam distillation to the sum of the Acorus calamus and the Semen Platycladi is (15-20):1; And / or, the steam distillation time is 5-7h.

6. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The mass ratio of the amount of water used in the water extraction to the sum of the medicinal residue and other raw materials is (15-25):1; And / or, the water extraction time is 1-2h; And / or, the water extraction temperature is 90-100°C.

7. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The method also comprises the following steps: preparing the volatile oil into an inclusion compound and then combining the inclusion compound with the extract.

8. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The mass ratio of the amount of alcohol used in the alcohol extraction 2 to the sum of the medicinal residue and other raw materials is (15-25):1; And / or, the alcohol extraction 2 takes 1-2 hours; And / or, the temperature of the alcohol extraction 2 is 70-80°C.

9. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicine for treating insomnia.

10. The use according to claim 9, characterized in that: The insomnia is an insomnia disorder characterized by liver depression transforming into fire and / or phlegm-fire disturbing the heart according to TCM syndrome differentiation.

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