A traditional Chinese medicine composition for improving insomnia, a traditional Chinese medicine preparation and a preparation method thereof

Abstract

The present application relates to the field of traditional Chinese medicine composition, and specifically discloses a traditional Chinese medicine composition for improving insomnia, a preparation method and a traditional Chinese medicine preparation. The traditional Chinese medicine composition comprises the following raw material components in mass fractions: 1-5 parts of Allium victorialis var. platyspathum, 1-20 parts of Rosa rubus, 1-15 parts of Caesalpinia sappan, 1-15 parts of Magnolia grandiflora, 1-15 parts of Ficus racemosa and 1-15 parts of Eclipta prostrata. The present application effectively treats insomnia through the combined action of the monarch, minister and auxiliary drugs. The traditional Chinese medicine preparation prepared by using the traditional Chinese medicine composition has the advantages of being less likely to cause drug resistance, having minimal toxic and side effects, being able to effectively improve the symptoms of insomnia, and enhancing the immune function of the body. The present application effectively solves the problems of poor body tolerance and high drug dependence caused by long-term medication of insomnia in the prior art, and the problems of high drug cost and limited efficacy of traditional Chinese medicine in treating insomnia, thereby providing a new idea and theoretical basis for the treatment of insomnia.

Description

Technical Field

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

[0002] Common clinical manifestations of insomnia include prolonged sleep latency, sleep maintenance disorders, early awakening, decreased sleep quality, shortened total sleep time, and daytime dysfunction. Among the more than 90 sleep disorders covered by the International Classification of Sleep Disorders, insomnia is the most common sleep disorder. Insomnia patients often suffer from sleep problems, and their excessive focus on sleep and overly high expectations for an ideal sleep state can lead to negative emotions such as depression, anxiety, and fear, causing significant harm to their physical and mental health. With socioeconomic development and the accelerated pace of life, people face increasing pressure from life, work, and study, resulting in a growing number of people suffering from insomnia, and a more pronounced trend of younger onset.

[0003] Currently, Western medicine mainly uses sedative-hypnotic drugs, anti-anxiety drugs, antidepressants, and hormone replacement therapy to treat insomnia. However, adverse reactions during medication have always been a challenge for these treatments, such as memory loss, decreased attention, fatigue, decreased quality of life, withdrawal reactions, and tolerance and dependence issues after long-term use. These are all reasons why insomnia patients have a negative attitude towards these drugs.

[0004] With the development of the traditional Chinese medicine (TCM) industry, more and more studies have shown that TCM treatment for insomnia has good clinical efficacy. One report describes a TCM composition for treating insomnia using a combination of herbs including Bupleurum, Curcuma longa, Salvia miltiorrhiza, Lilium brownii, Albizia julibrissin, stir-fried Ziziphus jujuba seeds, fossilized teeth, Polygonum multiflorum, Cornus officinalis, Cuscuta chinensis, Rehmannia glutinosa (raw and processed), Dioscorea opposita, Poria cocos, Gardenia jasminoides, Dipsacus asper, Cinnamomum cassia, Coptis chinensis, Schisandra chinensis, Magnetite, Scutellaria baicalensis, and Gentiana scabra, with significant and reliable efficacy. Another report describes a TCM composition for treating insomnia due to deficiency of both heart and spleen using a combination of herbs including Astragalus membranaceus, Atractylodes macrocephala, Angelica sinensis, Citrus reticulata peel, Crataegus pinnatifida, Hordeum vulgare, Raphanus sativus seeds, Cyperus rotundus, Polygonum multiflorum, Ziziphus jujuba seeds, Poria cocos, Glycyrrhiza uralensis, Poria cocos (raw and processed), Rehmannia glutinosa (processed), Ligusticum chuanxiong, Polygala tenuifolia, Fritillaria cirrhosa, Arisaema cum bile, Bupleurum chinense, and Anemarrhena asphodeloides. There are many reports of similar traditional Chinese medicine combinations for treating insomnia. However, they all use a combination of multiple drugs, and many of them contain expensive medicinal materials, which increases the cost of the drugs. Moreover, their effect on treating insomnia is limited, and they cannot effectively improve insomnia even after long-term use.

[0005] Therefore, developing a traditional Chinese medicine composition that can quickly and effectively relieve and treat insomnia symptoms at an affordable price is of great practical significance for the treatment of insomnia. Summary of the Invention

[0006] To address the problems of poor tolerance and high drug dependence caused by long-term use of Western and traditional Chinese medicine in treating insomnia, and the high cost and limited efficacy of traditional Chinese medicine in treating insomnia, this invention provides a traditional Chinese medicine composition, preparation, and preparation method for improving insomnia. The traditional Chinese medicine preparation made from the aforementioned composition has advantages such as low likelihood of drug resistance, minimal toxicity and side effects, effective improvement of insomnia symptoms, and enhancement of the body's immune function, providing a new approach and theoretical basis for the treatment of insomnia.

[0007] To solve the above-mentioned technical problems, the technical solution provided by the present invention is as follows: The first aspect of the present invention provides a traditional Chinese medicine composition for improving insomnia, the traditional Chinese medicine composition comprising the following raw material components in parts by weight: 1-5 parts of Zephyranthes candida, 1-20 parts of Rosa rugosa, 1-15 parts of Sappanwood, 1-15 parts of Magnolia grandiflora, 1-15 parts of Ficus hirta and 1-15 parts of Eclipta prostrata.

[0008] This invention uses *Zephyranthes candida*, *Rosa rugosa*, and *Caesalpinia sappan* as principal herbs, and *Magnolia grandiflora*, *Ficus hirta*, and *Eclipta prostrata* as assistant herbs. *Zephyranthes candida* is sweet and neutral in nature, and enters the liver meridian, possessing the effects of calming the liver, soothing the mind, calming the nerves, and relieving wind and sedation. *Rosa rugosa* enters the liver and spleen meridians, possessing the effects of soothing the liver and relieving depression, regulating the spleen and stomach, promoting blood circulation and qi flow, and calming the nerves and promoting sleep. *Caesalpinia sappan* is sweet and salty, neutral in nature, and non-toxic, entering the heart, liver, and spleen meridians; it possesses the effects of promoting blood circulation, breaking up blood stasis, reducing swelling, relieving pain, and inducing sleep. *Magnolia grandiflora* is pungent and warm in nature, entering the lung, stomach, and liver meridians; it possesses the effects of dispelling wind and cold, promoting qi circulation and relieving pain. *Ficus hirta* is sweet and slightly warm in nature, entering the spleen, lung, and liver meridians; it possesses the effects of strengthening the spleen and lungs, promoting qi circulation and removing dampness, and relaxing muscles and tendons. *Eclipta prostrata* is sweet and sour, cold in nature, and enters the liver and kidney meridians; it possesses the effects of nourishing the liver and kidneys, cooling the blood and stopping bleeding, and calming the nerves and removing dampness.

[0009] Preferably, the traditional Chinese medicine composition further includes the following raw material components in parts by weight: 1-16 parts of Polygonum multiflorum, 1-16 parts of Ziziphus jujuba var. spinosa, 1-12 parts of Salvia miltiorrhiza, 1-10 parts of Poria cocos, 1-5 parts of dragon bone, 1-5 parts of amber, and 1-5 parts of licorice.

[0010] This invention also uses Polygonum multiflorum, Ziziphus jujuba var. spinosa, and Salvia miltiorrhiza as adjuvants, and Poria cocos, fossilized bone, amber, and licorice as guiding herbs. Among them, Polygonum multiflorum is sweet and slightly bitter, neutral in nature, and enters the heart and spleen meridians; it has the effects of nourishing the heart and calming the mind, dispelling wind and unblocking the meridians; Ziziphus jujuba var. spinosa is sweet and sour, neutral in nature, and enters the liver, gallbladder and heart meridians; it has the effects of nourishing the heart and liver, calming the mind and soothing the mind, and clearing heat and relieving irritability; Salvia miltiorrhiza is pungent and slightly warm in nature, and enters the heart, liver and lung meridians; it has the effects of promoting blood circulation and regeneration, warming and unblocking the meridians, relieving irritability and calming the mind, and nourishing the heart and stabilizing the will; Poria cocos is sweet and bland in nature, neutral in nature; it enters the heart and spleen meridians, and has the effects of calming the mind, soothing the mind, and promoting diuresis; Os draconis is sweet and astringent in nature, neutral in nature; it enters the heart and liver meridians; it has the effects of calming the mind and soothing the nerves, calming the liver and suppressing yang, and astringing and consolidating; Amber is sweet in nature, neutral in nature; it enters the heart, liver and bladder meridians, and has the effects of calming the mind and soothing the nerves, promoting blood circulation and removing blood stasis, and promoting diuresis; Glycyrrhiza uralensis is neutral in nature and sweet in taste, enters the foot Taiyin and Jueyin meridians, and has the effects of dispelling external cold, removing pathogenic heat, relieving stagnation of qi, and nourishing yin and blood.

[0011] This invention utilizes the synergistic effects of principal, assistant, adjuvant, and guiding herbs to achieve a significant therapeutic effect on symptoms such as insomnia, excessive dreaming, difficulty falling asleep, shallow sleep with frequent awakenings, and depression or anxiety caused by sleep disorders. This effectively avoids the toxic side effects and adverse reactions that may result from Western medicine treatments for insomnia. More importantly, the herbal composition provided by this invention uses inexpensive and readily available medicinal materials, has a simple formulation, and exhibits good efficacy. The herbal preparations made using the herbal composition provided by this invention are less likely to develop drug resistance, have minimal toxic side effects, effectively improve insomnia symptoms, and enhance the body's immune function, providing new ideas and theoretical basis for the treatment of insomnia.

[0012] More preferably, the traditional Chinese medicine composition comprises the following raw material components in parts by weight: 2-3 parts of Zephyranthes candida, 8-15 parts of Rosa rugosa, 3-9 parts of Sappanwood, 4-12 parts of Magnolia grandiflora, 2-8 parts of Ficus hirta, 6-12 parts of Eclipta prostrata, 9-12 parts of Polygonum multiflorum, 10-12 parts of Ziziphus jujuba var. spinosa, 9-11 parts of Salvia miltiorrhiza, 3-6 parts of Poria cocos, 2-4 parts of fossilized bone, 2-4 parts of amber, and 2-4 parts of licorice.

[0013] A second aspect of the present invention provides a method for preparing the aforementioned traditional Chinese medicine composition for improving insomnia, comprising the following steps: Step 1: Dry the Zephyranthes candida, rose rosé, and sappanwood separately at 60℃-70℃, then pulverize them to obtain Zephyranthes candida powder, rose rosé powder, and sappanwood powder. Step 2: Immerse the *Allium tuberosum* powder in an alcohol solution to obtain a suspension; add a compound enzyme preparation to the suspension and perform microwave extraction at 25℃-30℃, followed by solid-liquid separation to obtain *Allium tuberosum* extract; Step 3: Immerse the dark red rose powder in an alcohol solution to obtain a suspension; add a compound enzyme preparation to the suspension and perform microwave extraction at 25℃-30℃, followed by solid-liquid separation to obtain dark red rose extract; Step 4: Immerse the sappanwood powder in an alcohol solution to obtain a suspension; add a compound enzyme preparation to the suspension and perform microwave extraction at 25℃-30℃, followed by solid-liquid separation to obtain sappanwood extract; Step 5: Mix all raw material components except for Zephyranthes candida, Rosa rugosa and Sappanwood evenly, crush them, and sieve them to obtain the first mixture; soak the first mixture in deionized water, boil it, boil for 10-15 minutes, and then decoct it at 60℃-70℃ to separate the solid and liquid, and obtain the filter residue and the first medicinal liquid. Step 6: Add the filter residue to the alcohol solution, soak for 1-3 hours, boil, boil for 5-10 minutes, then decoct at 55-65℃, filter, discard the filter residue, and obtain the second medicinal solution. Step 7: Mix the first medicinal liquid, the second medicinal liquid, the extract of Zephyranthes candida, the extract of Rosa rugosa, and the extract of Sappanwood evenly, and concentrate them at 50℃-75℃ to obtain a traditional Chinese medicine composition for improving insomnia.

[0014] Preferably, in step one, the drying time is 1-3 hours.

[0015] Preferably, in step one, the particle size of the pulverized Allium tuberosum powder is 100μm-250μm.

[0016] Preferably, in step one, the particle size of the pulverized dark red rose powder is 300μm-500μm.

[0017] Preferably, in step one, the particle size of the sappanwood powder after pulverization is 200μm-300μm.

[0018] Preferably, in step two, the alcohol solution is a 65%-70% ethanol solution; the mass-to-volume ratio of the allium leaf powder to the alcohol solution is 1g:4mL-1g:7mL.

[0019] Preferably, in step three, the alcohol solution is a 50%-60% ethanol solution; the mass-to-volume ratio of the dark red rose powder to the alcohol solution is 1g:3mL-1g:5mL.

[0020] Preferably, in step four, the alcohol solution is a 55%-65% ethanol solution, and the mass-to-volume ratio of the sappanwood powder to the alcohol solution is 1g:5mL-1g:8mL.

[0021] Preferably, in steps two, three, and four, the microwave extraction power is 200W-300W and the microwave extraction time is 5min-10min.

[0022] Preferably, in steps two, three, and four, the compound enzyme preparation consists of cellulase, pectinase, and protease in a mass ratio of 1:1:0.3 to 1:1:0.5.

[0023] Preferably, in steps two, three and four, the amount of the compound enzyme preparation added is 3wt%-5wt% of the suspension.

[0024] More preferably, in steps two, three and four, the enzyme activity of the cellulase is 15000U / g-20000U / g.

[0025] More preferably, in steps two, three and four, the activity of the pectinase is 20000U / g-30000U / g.

[0026] More preferably, in steps two, three and four, the enzyme activity of the protease is 3000 U / g-5000 U / g.

[0027] Preferably, in step five, the particle size of the first mixture is 100μm-200μm.

[0028] Preferably, the mass-to-volume ratio of the first mixture to deionized water is 1g:10mL to 1g:25mL.

[0029] Preferably, in step five, the simmering time is 1-3 hours.

[0030] Preferably, in step six, the alcohol solution is a 40%-55% ethanol solution; the mass-to-volume ratio of the filter residue to the alcohol solution is 1g:10mL-1g:20mL.

[0031] Preferably, in step six, the simmering time is 1-2 hours.

[0032] Preferably, in step seven, the relative density of the traditional Chinese medicine composition for improving insomnia is 1.08-1.10.

[0033] A third aspect of the present invention provides a traditional Chinese medicine preparation for improving insomnia, comprising the aforementioned traditional Chinese medicine composition for improving insomnia.

[0034] Preferably, the dosage form of the traditional Chinese medicine preparation is any one of granules, tablets, capsules, ointments, oral liquids, or pills.

[0035] In summary, this invention provides a traditional Chinese medicine composition, preparation, and preparation method for improving insomnia. It utilizes the principles of traditional Chinese medicine (TCM) principles (principal, assistant, adjuvant, and guide) to effectively treat insomnia. More importantly, the TCM composition provided by this invention uses inexpensive and readily available medicinal materials, has a simple formulation, and exhibits significant efficacy. The TCM preparation prepared using the TCM composition of this invention has advantages such as low likelihood of drug resistance, minimal toxicity and side effects, effective improvement of insomnia symptoms, and enhancement of the body's immune function. The technical solution of this invention effectively solves the problems of poor tolerance and high drug dependence caused by long-term use of Western medicine in treating insomnia, as well as the problems of high drug costs and limited efficacy in TCM treatment of insomnia, providing new ideas and theoretical basis for the treatment of insomnia. Detailed Implementation

[0036] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0037] Example 1 This embodiment provides a traditional Chinese medicine composition for improving insomnia, the details of which are as follows: The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 3g of Allium tuberosum, 12g of Rosa rugosa, 9g of Sappanwood, 9g of Magnolia grandiflora, 6g of Ficus hirta, 7g of Eclipta prostrata, 10g of Polygonum multiflorum, 10g of Ziziphus jujuba var. spinosa, 10g of Salvia miltiorrhiza, 4g of Poria cocos, 2g of fossilized bone, 2g of amber, and 2g of licorice.

[0038] The preparation method of the traditional Chinese medicine composition for improving insomnia includes the following steps: Step 1: Dry the Zephyranthes candida, rose rosé, and sappanwood at 65℃ for 2 hours, then pulverize them to obtain Zephyranthes candida powder with a particle size of 200μm, rose rosé powder with a particle size of 350μm, and sappanwood powder with a particle size of 250μm. Step 2: Disperse the Allium tuberosum powder in 10 mL of 70% ethanol solution and stir well to obtain a suspension; add 0.4 g of compound enzyme preparation to the suspension and perform microwave extraction at 28℃ and 250 W for 6 min, then separate the solid and liquid to obtain Allium tuberosum extract; Step 3: Disperse the dark red rose powder in 40 mL of 55% ethanol solution to obtain a suspension; add 1.4 g of compound enzyme preparation to the suspension, and perform microwave extraction at 25℃ and 250W for 6 min, then separate the solid and liquid to obtain dark red rose extract. Step 4: Disperse the sappanwood powder in 60 mL of 60% ethanol solution to obtain a suspension; add 2.2 g of compound enzyme preparation to the suspension, and perform microwave extraction at 29℃ and 250 W for 8 min, followed by solid-liquid separation to obtain sappanwood extract; Step 5: Mix all raw material components except for Zephyranthes candida, Rosa rugosa and Sappanwood evenly, crush and sieve to obtain a first mixture with a particle size of 150μm. Soak the first mixture in 950mL of deionized water, boil, boil for 12min, and then decoct at 65℃ for 2h. Separate the solid and liquid to obtain the filter residue and the first medicinal liquid. Step 6: Add the filter residue to 750 mL of 50% ethanol solution, soak for 2 hours, boil, boil for 6 minutes, then decoct at 60°C for 1.5 hours, filter, discard the filter residue, and obtain the second medicinal solution. Step 7: Mix the first medicinal liquid, the second medicinal liquid, the extract of Zephyranthes candida, the extract of Rosa rugosa, and the extract of Sappanwood evenly, and concentrate at 65°C. Stop the concentration when the relative density is 1.09, cool, and obtain the traditional Chinese medicine composition for improving insomnia.

[0039] The compound enzyme preparation comprises cellulase, pectinase, and protease in a mass ratio of 1:1:0.4; the cellulase has an enzyme activity of 20,000 U / g; the pectinase has an enzyme activity of 25,000 U / g; and the protease has an enzyme activity of 4,000 U / g.

[0040] Example 2 This embodiment provides a traditional Chinese medicine composition for improving insomnia, the details of which are as follows: The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 2g of Allium tuberosum, 15g of Rosa rugosa, 6g of Sappanwood, 10g of Magnolia grandiflora, 6g of Ficus hirta, 10g of Eclipta prostrata, 12g of Polygonum multiflorum, 11g of Ziziphus jujuba var. spinosa, 9g of Salvia miltiorrhiza, 3g of Poria cocos, 3g of Os draconis, 3g of Amber, and 4g of Glycyrrhiza uralensis.

[0041] The preparation method of the traditional Chinese medicine composition for improving insomnia includes the following steps: Step 1: Dry roast the Zephyranthes candida, rose rosé, and sappanwood at 65℃ for 2 hours, then pulverize them to obtain Zephyranthes candida powder with a particle size of 200μm, rose rosé powder with a particle size of 350μm, and sappanwood powder with a particle size of 250μm. Step 2: Disperse the Allium tuberosum powder in 10 mL of 70% ethanol solution and stir well to obtain a suspension; add 0.4 g of compound enzyme preparation to the suspension and perform microwave extraction at 28℃ and 250 W for 6 min, then separate the solid and liquid to obtain Allium tuberosum extract; Step 3: Disperse the dark red rose powder in 40 mL of 55% ethanol solution to obtain a suspension; add 1.4 g of compound enzyme preparation to the suspension, and perform microwave extraction at 25℃ and 250W for 6 min, then separate the solid and liquid to obtain dark red rose extract. Step 4: Disperse the sappanwood powder in 60 mL of 60% ethanol solution to obtain a suspension; add 2.1 g of compound enzyme preparation to the suspension, and perform microwave extraction at 29℃ and 250 W for 8 min, followed by solid-liquid separation to obtain sappanwood extract; Step 5: Mix all raw material components except for Zephyranthes candida, Rosa rugosa and Sappanwood evenly, crush and sieve to obtain a first mixture with a particle size of 150μm. Soak the first mixture in 1300mL of deionized water, boil, boil for 15min, and then decoct at 70℃ for 3h. Separate the solid and liquid to obtain the filter residue and the first medicinal liquid. Step 6: Add the filter residue to 1000mL of 50% ethanol solution, soak for 2 hours, boil, boil for 8 minutes, then decoct at 60℃ for 1.5 hours, filter, discard the filter residue, and obtain the second medicinal solution. Step 7: Mix the first medicinal liquid, the second medicinal liquid, the extract of Zephyranthes candida, the extract of Rosa rugosa, and the extract of Sappanwood evenly, and concentrate at 65°C. Stop the concentration when the relative density is 1.08, cool, and you will get a traditional Chinese medicine composition for improving insomnia.

[0042] The compound enzyme preparation comprises cellulase, pectinase, and protease in a mass ratio of 1:1:0.5; the cellulase has an enzyme activity of 15000 U / g; the pectinase has an enzyme activity of 20000 U / g; and the protease has an enzyme activity of 5000 U / g.

[0043] Example 3 This embodiment provides a traditional Chinese medicine composition for improving insomnia, the details of which are as follows: The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 2g of Allium tuberosum, 12g of Rosa rugosa, 8g of Sappanwood, 9g of Magnolia grandiflora, 7g of Ficus hirta, 7g of Eclipta prostrata, 11g of Polygonum multiflorum, 10g of Ziziphus jujuba var. spinosa, 9g of Salvia miltiorrhiza, 3g of Poria cocos, 2g of Os draconis, 2g of Amber, and 4g of Glycyrrhiza uralensis.

[0044] The preparation method of the traditional Chinese medicine composition for improving insomnia includes the following steps: Step 1: Dry roast the Zephyranthes candida, rose rosé, and sappanwood at 65℃ for 2 hours, then pulverize them to obtain Zephyranthes candida powder with a particle size of 200μm, rose rosé powder with a particle size of 350μm, and sappanwood powder with a particle size of 250μm. Step 2: Disperse the Allium tuberosum powder in 10 mL of 70% ethanol solution and stir well to obtain a suspension; add 0.4 g of compound enzyme preparation to the suspension and perform microwave extraction at 28℃ and 250 W for 6 min, then separate the solid and liquid to obtain Allium tuberosum extract; Step 3: Disperse the dark red rose powder in 40 mL of 55% ethanol solution to obtain a suspension; add 1.3 g of compound enzyme preparation to the suspension, and perform microwave extraction at 25℃ and 250 W for 6 min, then separate the solid and liquid to obtain dark red rose extract. Step 4: Disperse the sappanwood powder in 60 mL of 60% ethanol solution to obtain a suspension; add 2.3 g of compound enzyme preparation to the suspension, and perform microwave extraction at 29℃ and 250 W for 8 min, followed by solid-liquid separation to obtain sappanwood extract; Step 5: Mix all raw material components except for Zephyranthes candida, Rosa rugosa and Sappanwood evenly, crush and sieve to obtain a first mixture with a particle size of 150μm. Soak the first mixture in 1300mL of deionized water, boil, boil for 12min, and then decoct at 70℃ for 3h. Separate the solid and liquid to obtain the filter residue and the first medicinal liquid. Step 6: Add the filter residue to 950 mL of 45% ethanol solution, soak for 2 hours, boil, boil for 8 minutes, then decoct at 60°C for 2 hours, filter, discard the filter residue, and obtain the second medicinal solution. Step 7: Mix the first medicinal liquid, the second medicinal liquid, the extract of Zephyranthes candida, the extract of Rosa rugosa, and the extract of Sappanwood evenly, and concentrate at 70°C. Stop the concentration when the relative density is 1.10, cool, and obtain the traditional Chinese medicine composition for improving insomnia.

[0045] The compound enzyme preparation comprises cellulase, pectinase, and protease in a mass ratio of 1:1:0.3; the cellulase has an enzyme activity of 20,000 U / g; the pectinase has an enzyme activity of 30,000 U / g; and the protease has an enzyme activity of 3,000 U / g.

[0046] Comparative Example 1 This comparative example provides a traditional Chinese medicine composition for improving insomnia. The composition replaces the Allium tuberosum in Example 1 with an equal amount of Citronella, while keeping other components and preparation process unchanged. Specifically, it includes the following contents.

[0047] The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: citron 3g, dark red rose 12g, sappanwood 9g, magnolia 9g, five-finger peach 6g, eclipta prostrata 7g, night-blooming jasmine 10g, jujube seed 10g, salvia miltiorrhiza 10g, poria cocos 4g, dragon bone 2g, amber 2g, and licorice 2g.

[0048] The preparation method of the traditional Chinese medicine composition for improving insomnia includes the following steps: Step 1: Dry roast citron, dark red rose and sappanwood at 65℃ for 2 hours, then pulverize to obtain citron powder with a particle size of 200μm, dark red rose powder with a particle size of 350μm and sappanwood powder with a particle size of 250μm. Step 2: Disperse citron powder in 10 mL of 70% ethanol solution and stir evenly to obtain a suspension; add 0.4 g of compound enzyme preparation to the suspension and perform microwave extraction at 28℃ and 250W for 6 min, then separate the solid and liquid to obtain citron extract. Step 3: Disperse the dark red rose powder in 40 mL of 55% ethanol solution to obtain a suspension; add 1.4 g of compound enzyme preparation to the suspension, and perform microwave extraction at 25℃ and 250W for 6 min, then separate the solid and liquid to obtain dark red rose extract. Step 4: Disperse the sappanwood powder in 60 mL of 60% ethanol solution to obtain a suspension; add the compound enzyme preparation to the suspension and perform microwave extraction at 29℃ and 250W for 8 min, then separate the solid and liquid to obtain the sappanwood extract. Step 5: Mix all raw material components except citron, dark red rose and sappanwood evenly, crush and sieve to obtain a first mixture with a particle size of 150μm. Soak the first mixture in 950mL of deionized water, boil, boil for 12min, and then decoct at 65℃ for 2h. Separate the solid and liquid to obtain the filter residue and the first medicinal liquid. Step 6: Add the filter residue to 750 mL of 50% ethanol solution, soak for 2 hours, boil, boil for 6 minutes, then decoct at 60°C for 1.5 hours, filter, discard the filter residue, and obtain the second medicinal solution. Step 7: Mix the first medicinal liquid, the second medicinal liquid, the citron extract, the dark red rose extract, and the sappanwood extract evenly, and concentrate them at 65°C. Stop the concentration when the relative density is 1.09, cool, and you will get a traditional Chinese medicine composition for improving insomnia.

[0049] The compound enzyme preparation comprises cellulase, pectinase, and protease in a mass ratio of 1:1:0.4; the cellulase has an enzyme activity of 20,000 U / g; the pectinase has an enzyme activity of 25,000 U / g; and the protease has an enzyme activity of 4,000 U / g.

[0050] Comparative Example 2 This comparative example provides a traditional Chinese medicine composition for improving insomnia, in which the dark red rose in Example 1 is replaced with an equal amount of Albizia bark, while other components and preparation processes remain unchanged, specifically including the following contents.

[0051] The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 3g of Allium tuberosum, 12g of Albizia julibrissin bark, 9g of Sappanwood, 9g of Magnolia grandiflora, 6g of Ficus hirta, 7g of Eclipta prostrata, 10g of Polygonum multiflorum, 10g of Ziziphus jujuba var. spinosa, 10g of Salvia miltiorrhiza, 4g of Poria cocos, 2g of fossilized bone, 2g of amber, and 2g of licorice.

[0052] The preparation method of the traditional Chinese medicine composition for improving insomnia includes the following steps: Step 1: Dry-roast the celery, albizia bark, and sappanwood at 65℃ for 2 hours, then pulverize them to obtain celery powder with a particle size of 200μm, albizia bark powder with a particle size of 350μm, and sappanwood powder with a particle size of 250μm. Step 2: Disperse the Allium tuberosum powder in 10 mL of 70% ethanol solution and stir well to obtain a suspension; add 0.4 g of compound enzyme preparation to the suspension and perform microwave extraction at 28℃ and 250 W for 6 min, then separate the solid and liquid to obtain Allium tuberosum extract; Step 3: Disperse the Albizia bark powder in 40 mL of 55% ethanol solution to obtain a suspension; add 1.4 g of compound enzyme preparation to the suspension, and perform microwave extraction at 25℃ and 250W for 6 min, followed by solid-liquid separation to obtain Albizia bark extract; Step 4: Disperse the sappanwood powder in 60 mL of 60% ethanol solution to obtain a suspension; add the compound enzyme preparation to the suspension and perform microwave extraction at 29℃ and 250W for 8 min, then separate the solid and liquid to obtain the sappanwood extract. Step 5: Mix all raw material components except for Allium tuberosum, Albizia julibrissin bark and Sappanwood evenly, crush and sieve to obtain a first mixture with a particle size of 150μm. Soak the first mixture in 950mL of deionized water, boil, boil for 12min, and then decoct at 65℃ for 2h. Separate the solid and liquid to obtain the filter residue and the first medicinal liquid. Step 6: Add the filter residue to 750 mL of 50% ethanol solution, soak for 2 hours, boil, boil for 6 minutes, then decoct at 60°C for 1.5 hours, filter, discard the filter residue, and obtain the second medicinal solution. Step 7: Mix the first medicinal solution, the second medicinal solution, the extract of Allium tuberosum, the extract of Albizia julibrissin bark, and the extract of Sappanwood evenly, and concentrate at 65°C. Stop the concentration when the relative density is 1.09, cool, and obtain the traditional Chinese medicine composition for improving insomnia.

[0053] The compound enzyme preparation comprises cellulase, pectinase, and protease in a mass ratio of 1:1:0.4; the cellulase has an enzyme activity of 20,000 U / g; the pectinase has an enzyme activity of 25,000 U / g; and the protease has an enzyme activity of 4,000 U / g.

[0054] Comparative Example 3 This comparative example provides a traditional Chinese medicine composition for improving insomnia, in which the sappanwood in Example 1 is replaced with an equal amount of tribulus terrestris, while other components and preparation processes remain unchanged. Specifically, it includes the following: The raw materials for preparing this traditional Chinese medicine composition include the following components in parts by weight: 3g of Allium tuberosum, 12g of Rosa rugosa, 9g of Tribulus terrestris, 9g of Magnolia grandiflora, 6g of Ficus hirta, 7g of Eclipta prostrata, 10g of Polygonum multiflorum, 10g of Ziziphus jujuba var. spinosa, 10g of Salvia miltiorrhiza, 4g of Poria cocos, 2g of fossilized bone, 2g of amber, and 2g of licorice.

[0055] The preparation method of the traditional Chinese medicine composition for improving insomnia includes the following steps: Step 1: Dry roast the celestial lily, dark red rose and white tribulus at 65℃ for 2 hours, then pulverize them to obtain celestial lily powder with a particle size of 200μm, dark red rose powder with a particle size of 350μm and white tribulus powder with a particle size of 250μm. Step 2: Disperse the Allium tuberosum powder in 10 mL of 70% ethanol solution and stir well to obtain a suspension; add 0.4 g of compound enzyme preparation to the suspension and perform microwave extraction at 28℃ and 250 W for 6 min, then separate the solid and liquid to obtain Allium tuberosum extract; Step 3: Disperse the dark red rose powder in 40 mL of 55% ethanol solution to obtain a suspension; add 1.4 g of compound enzyme preparation to the suspension, and perform microwave extraction at 25℃ and 250W for 6 min, then separate the solid and liquid to obtain dark red rose extract. Step 4: Disperse Tribulus terrestris powder in 60 mL of 60% ethanol solution to obtain a suspension; add a compound enzyme preparation to the suspension and perform microwave extraction at 29℃ and 250W for 8 min, then separate the solid and liquid to obtain Tribulus terrestris extract. Step 5: Mix all raw material components except for Zephyranthes candida, rose 'Dark Red' and Tribulus terrestris evenly, crush and sieve to obtain a first mixture with a particle size of 150μm. Soak the first mixture in 950mL of deionized water, boil, boil for 12min, and then decoct at 65℃ for 2h. Separate the solid and liquid to obtain the filter residue and the first medicinal liquid. Step 6: Add the filter residue to 750 mL of 50% ethanol solution, soak for 2 hours, boil, boil for 6 minutes, then decoct at 60°C for 1.5 hours, filter, discard the filter residue, and obtain the second medicinal solution. Step 7: Mix the first medicinal liquid, the second medicinal liquid, the extract of Zephyranthes candida, the extract of Rosa rugosa, and the extract of Tribulus terrestris evenly, and concentrate them at 65°C. Stop the concentration when the relative density is 1.09, cool, and you will get a traditional Chinese medicine composition for improving insomnia.

[0056] The compound enzyme preparation comprises cellulase, pectinase, and protease in a mass ratio of 1:1:0.4; the cellulase has an enzyme activity of 20,000 U / g; the pectinase has an enzyme activity of 25,000 U / g; and the protease has an enzyme activity of 4,000 U / g.

[0057] Comparative Example 4 This comparative example provides a commercially available diazepam tablet in a 2.5mg strength.

[0058] Experimental Example 1 This experimental example provides a traditional Chinese medicine granule for improving insomnia, using the traditional Chinese medicine composition provided in Example 1, specifically including the following steps: Add 30g of medicinal starch, 0.5g of sodium carboxymethyl cellulose, and 0.3g of β-cyclodextrin to 10g of the traditional Chinese medicine composition obtained in Example 1, mix well, and granulate to obtain traditional Chinese medicine granules for improving insomnia.

[0059] Experimental Example 2 This experimental example provides a traditional Chinese medicine tablet for improving insomnia, using the traditional Chinese medicine composition provided in Example 1, specifically including the following steps: Add 150g of medicinal starch, 2.5g of sodium carboxymethyl cellulose, and 1.5g of β-cyclodextrin to 50g of the traditional Chinese medicine composition obtained in Example 1, mix evenly, granulate, and compress into tablets to obtain traditional Chinese medicine tablets for improving insomnia.

[0060] The traditional Chinese medicine compositions obtained in Examples 2-3 and Comparative Examples 1-3 can also be used to prepare traditional Chinese medicine preparations of relevant dosage forms through experimental methods, which will not be elaborated here.

[0061] To demonstrate the technical effects of the present invention, the drugs obtained in Examples 1-3 and Comparative Examples 1-4 were tested as follows: 1.1 Safety Test Test animals: SD rats, weighing 180-220g, 10 rats per group, half male and half female.

[0062] Test drug: Traditional Chinese medicine granules prepared using the traditional Chinese medicine compositions for improving insomnia obtained in Examples 1-3 and Comparative Examples 1-3.

[0063] Blank control group: physiological saline.

[0064] Administration method: Gavage administration. The test drugs of Examples 1-3 and Comparative Examples 1-3 were mixed evenly with physiological saline to prepare a test solution with a concentration of 100 mg / kg. The dosage based on the rat's body weight was 20 mL / kg, once a day for 7 consecutive days. During the administration period, the rats were fed a normal diet, kept at a temperature of 25±1℃ and a relative humidity of 60%-70%.

[0065] Group 1: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 1; Group 2: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 2; Group 3: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 3; Group 4: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 1; Group 5: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 2; Group 6: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 3; Group 7: Blank control group (physiological saline).

[0066] Detailed records were kept of rat mortality, weight, food intake, water intake, fur, activity, eyes, feces, mental state, and any toxic reactions. Rats were sacrificed after 7 days, and changes in major organs were observed. The test results are shown in Table 1.

[0067] Table 1. Results of toxicity tests

[0068] 1.2 Acute toxicity test Test animals: SD rats, weighing 180-220g, 10 rats per group, half male and half female.

[0069] Test drug: Traditional Chinese medicine granules prepared using the traditional Chinese medicine compositions for improving insomnia obtained in Examples 1-3 and Comparative Examples 1-3.

[0070] Blank control group: physiological saline.

[0071] Administration method: Gavage administration. The test drugs of Examples 1-3 and Comparative Examples 1-3 were mixed evenly with physiological saline to prepare a test solution with a concentration of 100 mg / kg. The initial dose based on rat body weight was 20 mL / kg. Rats were then administered drugs at 100, 140, 160, 180, 200, and 220 times the clinical daily dose, respectively. During the administration period, rats were kept on a normal diet, at a temperature of 25±1℃, and with a relative humidity of 60%-70%.

[0072] Group 1: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 1; Group 2: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 2; Group 3: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 3; Group 4: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 1; Group 5: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 2; Group 6: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 3; Group 8: Blank control group (physiological saline).

[0073] Seven days after the last administration, rats were observed, and detailed records were kept of their mortality, weight, food intake, water intake, fur, activity, eyes, feces, mental state, and any toxic reactions. After seven days, the rats were sacrificed, and changes in major organs were observed. The results showed that no animals died and no obvious toxic reactions were observed.

[0074] 1.3 Animal Model Experiments of p-Chlorophenylalanine (PCPA) p-Chlorophenylalanine (PCPA), as an inhibitor of tryptophan hydroxylase, can block and deplete the synthesis of serotonin in the brain, thereby inducing insomnia. PCPA was dissolved in physiological saline to prepare a suspension, and rats were injected intraperitoneally at a dose of 250 mg / (kg·rat) once daily for 3 consecutive days. Observations revealed that the rats exhibited a loss of circadian rhythm, with constant activity day and night, reduced or absent sleep, increased food and water intake, disheveled fur, lethargy, and significantly weakened resistance upon re-stimulation. Overall, the rats showed marked differences from normal animals, indicating successful model establishment.

[0075] Experimental animals: SD rats, weighing 180-220g, 10 rats per group, half male and half female.

[0076] Administration method: Gavage administration. The drugs provided in Examples 1-3 and Comparative Examples 1-4 were prepared into samples with a concentration of 100 mg / kg using physiological saline as a solvent. Each administration was 20 mL / kg based on the rat's body weight. The normal control group and the model control group were given the same volume of physiological saline. The administration was once a day for 7 days. During the administration period, the rats were fed a normal diet, kept at a temperature of 25±1℃, and a relative humidity of 60%-70%.

[0077] Experimental group: Group 1: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 1; Group 2: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 2; Group 3: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 3; Group 4: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 1; Group 5: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 2; Group 6: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Comparative Example 3; Group 7: The Western medicine group provided in Comparative Example 4; Group 8: Normal control group; Group 9: Model control group.

[0078] Effects on rat body weight and spontaneous activity: Behavioral changes in rats were observed daily, and rat body weight was measured and recorded. The results are shown in Table 2.

[0079] Table 2. Statistics on rat weight changes

[0080] Notes: * indicates comparison with the normal control group, P < 0.05; # indicates comparison with the model control group, P < 0.05; ! indicates comparison with the Western medicine group provided in Comparative Example 4, P < 0.05.

[0081] As shown in Table 2, after modeling, compared with the normal control group, the body weight of rats in the model control group and the drug administration groups of Examples 1-3 and Comparative Examples 1-4 was significantly reduced, and the differences were statistically significant (P < 0.05). After drug treatment, compared with the normal control group, the body weight of rats in the model control group was significantly increased, and the difference was statistically significant (P < 0.05). Compared with the model control group, the body weight gain of rats in the drug administration groups of Examples 1-3 and Comparative Examples 1-4 was significantly increased, and the differences were statistically significant (P < 0.05). Compared with the western medicine control group provided in Comparative Example 4, the degree of body weight gain of rats in the drug administration groups of Examples 1-3 was significantly greater than that in the western medicine group of Comparative Example 4, and the differences were statistically significant (P < 0.05).

[0082] Pentobarbital sodium sleep duration test: 30 minutes after the last administration, each group of rats was given 40 mg / kg of pentobarbital sodium via intraperitoneal injection. The rats' sleep patterns were recorded, and the righting reflex was observed within 30 minutes. The absence of the righting reflex for more than 1 minute was considered as the occurrence of sleep phenomenon, and the number of sleeping mice was recorded. The time from intraperitoneal injection of sodium pentobarbital to the disappearance of the righting reflex was taken as the sleep latency. The time from the disappearance of the righting reflex to its recovery was taken as the sleep time of the rat. The sleep status of the rats was observed and recorded, and the results are shown in Table 3.

[0083] Table 3. Statistics on sleep patterns in rats

[0084] Notes: * indicates comparison with the normal control group, P < 0.05; # indicates comparison with the model control group, P < 0.05; ! indicates comparison with the Western medicine group provided in Comparative Example 4, P < 0.05.

[0085] As shown in Table 3, compared with the normal control group, the sleep latency of rats in the model control group was significantly increased and the sleep duration was significantly shortened, with statistically significant differences (P < 0.05), indicating successful model establishment. Compared with the model control group, the sleep latency of rats in each drug administration group was significantly shortened and the sleep duration was significantly prolonged, with statistically significant differences (P < 0.05). Compared with the Western medicine group provided in Comparative Example 4, the sleep latency of rats in each group of Examples 1-3 of this invention was slightly prolonged and the sleep duration was slightly shortened, with statistically significant differences (P < 0.05).

[0086] 1.4 Tolerance Test Experimental animals: SD rats, weighing 180-220g, 10 rats per group, half male and half female.

[0087] Rat Model Establishment: Parachlorophenylalanine (PCPA), as an inhibitor of tryptophan hydroxylase, can block and deplete the synthesis of serotonin in the brain, thereby inducing insomnia. PCPA was dissolved in physiological saline to prepare a suspension, and rats were injected intraperitoneally at a dose of 250 mg / (kg·rat) once daily for 3 consecutive days. Observations revealed that the rats' diurnal rhythm was lost, with constant activity day and night, reduced or even absent sleep, increased food and water intake, disheveled fur, and lethargy. Upon re-stimulation, resistance was significantly weakened. Overall, the rats showed significant differences from normal animals, indicating successful model establishment.

[0088] Administration method: Gavage administration. The drugs provided in Examples 1-3 and Comparative Example 4 were prepared into samples with a concentration of 100 mg / kg using physiological saline as a solvent. Each administration was 20 mL / kg based on the rat's body weight. The normal control group and the model control group were given the same volume of physiological saline. The administration was once a day for 7 days. During the administration period, the rats were fed a normal diet, kept at a temperature of 25±1℃, and a relative humidity of 60%-70%.

[0089] Experimental group: Group 1: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 1; Group 2: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 2; Group 3: Traditional Chinese medicine granules prepared using the traditional Chinese medicine composition for improving insomnia obtained in Example 3; Group 4: The Western medicine group provided in Comparative Example 4; Group 5: Model control group.

[0090] Each group was administered the drug continuously for 30 days. On the 10th, 20th and 30th days, 30 minutes after gavage administration, the sleep latency and sleep duration of rats were measured to observe the tolerance of the drug to sleep improvement. The results are shown in Table 4.

[0091] Table 4. Tolerance test results

[0092] Note: * indicates comparison with the model control group, P < 0.05; △ indicates comparison between day 10 and day 20, P < 0.05; ☆ indicates comparison between day 20 and day 30, P < 0.05.

[0093] As shown in Table 4, compared with the model control group, the sleep latency of rats in each group of Examples 1-3 and the Western medicine control group was significantly shortened, and the sleep duration was significantly prolonged. All differences in the model control group were statistically significant (P < 0.05). With prolonged medication, the sleep latency of the model control group was significantly prolonged, and the sleep duration was significantly shortened, with statistically significant differences. In contrast, the sleep latency of rats in each group of Examples 1-3 was significantly shortened, and the sleep duration was significantly prolonged, with statistically significant differences (P < 0.05). While the sleep latency of the Western medicine control group did not differ significantly with prolonged medication, the sleep duration was significantly shortened, with statistically significant differences (P < 0.05). It can be seen that the traditional Chinese medicine preparation for improving insomnia prepared using the traditional Chinese medicine composition provided in the examples of this invention has good tolerability compared to Western medicine.

[0094] As can be seen from the above, the traditional Chinese medicine preparation made using the traditional Chinese medicine composition for improving insomnia provided by this invention can effectively improve insomnia symptoms, with significant efficacy. It is comparable to commercially available Western medicines and does not cause problems such as poor body tolerance and high drug dependence, thus providing a new treatment approach for insomnia.

[0095] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for improving insomnia, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 2-3 parts of Zephyranthes candida, 8-15 parts of Rosa rugosa, 3-9 parts of Sappanwood, 4-12 parts of Magnolia grandiflora, 2-8 parts of Ficus hirta, 6-12 parts of Eclipta prostrata, 9-12 parts of Polygonum multiflorum, 10-12 parts of Ziziphus jujuba var. spinosa, 9-11 parts of Salvia miltiorrhiza, 3-6 parts of Poria cocos, 2-4 parts of fossilized bone, 2-4 parts of amber, and 2-4 parts of licorice.

2. A method for preparing a traditional Chinese medicine composition for improving insomnia as described in claim 1, characterized in that: Includes the following steps: Step 1: Dry the Zephyranthes candida, rose rosé, and sappanwood separately at 60℃-70℃, then pulverize them to obtain Zephyranthes candida powder, rose rosé powder, and sappanwood powder. Step 2: Immerse the *Allium tuberosum* powder in an alcohol solution to obtain a suspension; add a compound enzyme preparation to the suspension and perform microwave extraction at 25℃-30℃, followed by solid-liquid separation to obtain *Allium tuberosum* extract; Step 3: Immerse the dark red rose powder in an alcohol solution to obtain a suspension; add a compound enzyme preparation to the suspension and perform microwave extraction at 25℃-30℃, followed by solid-liquid separation to obtain dark red rose extract; Step 4: Immerse the sappanwood powder in an alcohol solution to obtain a suspension; add a compound enzyme preparation to the suspension and perform microwave extraction at 25℃-30℃, followed by solid-liquid separation to obtain sappanwood extract; Step 5: Mix all raw materials except for Allium tuberosum, Rosa rugosa and Sappanwood evenly, crush them, and sieve them to obtain the first mixture; soak the first mixture in deionized water, boil it, boil for 10-15 minutes, and then decoct it at 60℃-70℃ to separate the solid and liquid, and obtain the filter residue and the first medicinal liquid. Step 6: Add the filter residue to the alcohol solution, soak for 1-3 hours, boil, boil for 5-10 minutes, then decoct at 55-65℃, filter, discard the filter residue, and obtain the second medicinal solution. Step 7: Mix the first medicinal liquid, the second medicinal liquid, the extract of Zephyranthes candida, the extract of Rosa rugosa, and the extract of Sappanwood evenly, and concentrate them at 50℃-75℃ to obtain a traditional Chinese medicine composition for improving insomnia.

3. The method for preparing the traditional Chinese medicine composition for improving insomnia as described in claim 2, characterized in that: In step one, the drying time is 1-3 hours; and / or In step two, the alcohol solution is a 65%-70% ethanol solution; the mass-to-volume ratio of the allium leaf powder to the alcohol solution is 1g:4mL-1g:7mL; and / or In step three, the alcohol solution is a 50%-60% ethanol solution; the mass-to-volume ratio of the dark red rose powder to the alcohol solution is 1g:3mL-1g:5mL; and / or In step four, the alcohol solution is a 55%-65% ethanol solution; the mass-to-volume ratio of the sappanwood powder to the alcohol solution is 1g:5mL-1g:8mL.

4. The method for preparing the traditional Chinese medicine composition for improving insomnia as described in claim 2, characterized in that: In steps two, three, and four, the microwave extraction power is 200W-300W, and the microwave extraction time is 5min-10min; and / or In steps two, three, and four, the compound enzyme preparation consists of cellulase, pectinase, and protease in a mass ratio of 1:1:0.3 to 1:1:0.5; and / or In steps two, three, and four, the amount of the compound enzyme preparation added is 3wt%-5wt% of the suspension.

5. The method for preparing the traditional Chinese medicine composition for improving insomnia as described in claim 4, characterized in that: In steps two, three, and four, the cellulase activity is 15000 U / g-20000 U / g; and / or In steps two, three, and four, the pectinase activity is 20,000 U / g-30,000 U / g; and / or In steps two, three, and four, the enzyme activity of the protease is 3000 U / g-5000 U / g.

6. The method for preparing the traditional Chinese medicine composition for improving insomnia as described in claim 2, characterized in that: In step five, the particle size of the first mixture is 100 μm-200 μm; and / or In step five, the mass-to-volume ratio of the first mixture to deionized water is 1g:10mL to 1g:25mL; and / or In step five, the simmering time is 1-3 hours; and / or In step six, the alcohol solution is a 40%-55% ethanol solution; the mass-to-volume ratio of the filter residue to the alcohol solution is 1g:10mL-1g:20mL; and / or In step six, the simmering time is 1-2 hours; and / or In step seven, the relative density of the traditional Chinese medicine composition for improving insomnia is 1.08-1.

10.

7. A traditional Chinese medicine preparation for improving insomnia, characterized in that: It is made from the traditional Chinese medicine composition for improving insomnia as described in claim 1.

8. The traditional Chinese medicine preparation for improving insomnia as described in claim 7, characterized in that: The dosage form of the traditional Chinese medicine preparation is any one of granules, tablets, capsules, ointments, oral liquids, or pills.

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