Traditional Chinese medicine essential oil composition for preventing and / or treating insomnia as well as preparation method and application of traditional Chinese medicine essential oil composition

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine essential oil composition for preventing and / or treating insomnia and a preparation method and application thereof. The traditional Chinese medicine essential oil composition is prepared from vetiver, benzoin, polygala tenuifolia, agilawood, bitter orange flowers, lavender, longan aril, poria cocos, lotus seeds, ganoderma lucidum, radix ophiopogonis and amber. Comprising 10-20 parts of vetiver, 10-20 parts of benzoin, 1-5 parts of polygala tenuifolia, 5-15 parts of agilawood, 0.5-1 part of bitter orange flower, 0.5-2 parts of lavender, 5-15 parts of longan aril, 10-20 parts of poria cocos, 10-20 parts of lotus seeds, 1-5 parts of ganoderma lucidum, 1-5 parts of radix ophiopogonis and 3-8 parts of amber. By limiting the proportion of the raw materials in the prescription, the synergistic effect of the components can be better exerted, the advantages are enhanced, the disadvantages are avoided, and the best effect of treating insomnia is achieved to the maximum extent.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine essential oil composition for preventing and / or treating insomnia, and a preparation method and application thereof. Background Art

[0002] In modern society, the fast-paced lifestyle has caused people to face increasing work and life pressures, and sleep problems have become more common. Sleep disorders such as insomnia, shallow sleep, and dreaming not only seriously affect people's daily quality of life, but long-term accumulation may also cause a series of health risks, such as reduced immunity, mental depression, and memory loss. At present, there are many types of products on the market to improve sleep, but they all have certain limitations. Although pharmaceutical products can improve sleep to a certain extent, they are often accompanied by side effects, and long-term use may cause damage to the body; ordinary sleep aids, such as earplugs, eye masks, etc., can only make limited improvements in the external environment, and it is difficult to fundamentally solve sleep problems.

[0003] Essential oils are natural plant essences with volatility and biological activity. They can regulate physiological and psychological states through olfactory nerves and percutaneous absorption, and have broad application prospects in improving sleep. However, the existing sleep-aiding essential oils still have a lot of room for improvement in formula and efficacy, and cannot fully meet consumers' demand for safe, efficient, and natural sleep-aiding products. It is urgent to develop a new and more effective sleep-aiding essential oil. Summary of the invention

[0004] Therefore, the technical problem to be solved by the present invention is to overcome the defect of the prior art that there is a lack of an effective Chinese medicinal essential oil composition for preventing and / or treating insomnia, thereby providing a Chinese medicinal essential oil composition for preventing and / or treating insomnia and a preparation method and application thereof.

[0005] In a first aspect, the present application provides a Chinese herbal essential oil composition, the raw materials of which include: vetiver, benzoin, polygala, agarwood, bitter orange flower, lavender, longan pulp, Poria cocos, lotus seeds, Ganoderma lucidum, Ophiopogon japonicus and amber.

[0006] Furthermore, the raw materials of the Chinese medicine essential oil composition include, by weight: 10-20 parts of vetiver, 10-20 parts of benzoin, 1-5 parts of polygala, 5-15 parts of agarwood, 0.5-1 parts of bitter orange flower, 0.5-2 parts of lavender, 5-15 parts of longan pulp, 10-20 parts of Poria cocos, 10-20 parts of lotus seeds, 1-5 parts of Ganoderma lucidum, 1-5 parts of Ophiopogon japonicus and 3-8 parts of amber.

[0007] Among them, the vetiver is the dried root of Chrysopogon zizanioides (Linnaeus) Roberty, a plant of the genus Chrysopogon in the Poaceae family.

[0008] Lavender: A plant of the genus Lavandula in the Lamiaceae family, with the Latin name Lavandula angustifolia Mill. The lavender selected in this invention refers to the parts of lavender except the roots.

[0009] Amber: A fossil-like substance formed by the resin of ancient pine plants, such as maple trees and pine trees, buried underground for many years. When used, it is ground into fine powder.

[0010] Ganoderma lucidum: The dried fruiting body of the fungus Ganoderma lucidum (Leyss. ex Fr.) Karst. or Ganoderma sinense Zhao, Xu et Zhang in the family Polyporaceae.

[0011] Bitter orange flower: The white petals of the plant Citrus bigarradia in the Rutaceae family.

[0012] Lotus seed: The dried and mature seeds of the plant Nelumbo nucifera Gaertn. in the Nymphaeaceae family.

[0013] Poria cocos: The dried sclerotium of the fungus Poria cocos (Schw.) Wolf in the family Polyporaceae.

[0014] Longan aril: The aril of the plant Dimocarpus longan Lour. in the Sapindaceae family.

[0015] Agarwood: The wood containing resin of the plant Aquilaria sinensis (Lour.) Gilg in the Thymelaeaceae family.

[0016] Benzoin: The dried resin of the plant Styrax tonkinensis (Pierre) Craib ex Hart. in the family Styracaceae.

[0017] Dwarf lilyturf tuber: The dried tuberous roots of the plant Ophiopogon japonicus (L.f) Ker-Gawl. in the Liliaceae family.

[0018] Polygala root: The dried roots of the plants Polygala tenuifolia Willd. or Polygala sibirica L. in the family Polygalaceae.

[0019] Further, by weight parts, the raw materials of the traditional Chinese medicine essential oil composition include: 15 parts of vetiver, 15 parts of benzoin, 3 parts of polygala root, 10 parts of agarwood, 0.8 part of neroli, 1.5 parts of lavender, 10 parts of longan pulp, 15 parts of poria cocos, 15 parts of lotus seeds, 3 parts of ganoderma lucidum, 3 parts of ophiopogon japonicus, and 4 parts of amber; or,

[0020] the raw materials of the traditional Chinese medicine essential oil composition include: 18 parts of vetiver, 18 parts of benzoin, 2 parts of polygala root, 8 parts of agarwood, 1 part of neroli, 1 part of lavender, 8 parts of longan pulp, 18 parts of poria cocos, 18 parts of lotus seeds, 2 parts of ganoderma lucidum, 2 parts of ophiopogon japonicus, and 5 parts of amber; or,

[0021] the raw materials of the traditional Chinese medicine essential oil composition include: 10 parts of vetiver, 20 parts of benzoin, 1 part of polygala root, 15 parts of agarwood, 0.5 part of neroli, 2 parts of lavender, 5 parts of longan pulp, 20 parts of poria cocos, 10 parts of lotus seeds, 1 part of ganoderma lucidum, 5 parts of ophiopogon japonicus, and 3 parts of amber; or,

[0022] the raw materials of the traditional Chinese medicine essential oil composition include: 20 parts of vetiver, 10 parts of benzoin, 5 parts of polygala root, 5 parts of agarwood, 1 part of neroli, 0.5 part of lavender, 15 parts of longan pulp, 10 parts of poria cocos, 20 parts of lotus seeds, 5 parts of ganoderma lucidum, 1 part of ophiopogon japonicus, and 8 parts of amber.

[0023] Further, the traditional Chinese medicine essential oil composition includes an extract obtained by extracting the raw materials by a conventional extraction method;

[0024] Optionally, the conventional extraction method includes one or more of supercritical carbon dioxide extraction method, distillation method, solvent extraction method, cold pressing method, microwave-assisted method, ultrasonic-assisted method, and enzyme-assisted method.

[0025] In a second aspect, the present application also provides a preparation method of the traditional Chinese medicine essential oil composition described in any one of the above, including the following steps: weighing vetiver, benzoin, polygala root, agarwood, neroli, lavender, longan pulp, poria cocos, lotus seeds, ganoderma lucidum, ophiopogon japonicus, and amber according to the selected weight parts, mixing and then extracting by a conventional extraction method or separately extracting by a conventional extraction method and then mixing to obtain the product.

[0026] Further, the conventional extraction method includes one or more of supercritical carbon dioxide extraction method, distillation method, solvent extraction method, cold pressing method, microwave-assisted method, ultrasonic-assisted method, and enzyme-assisted method.

[0027] Further, the preparation method of the traditional Chinese medicine essential oil composition includes:

[0028] (1) Weigh the raw materials according to the selected weight parts and set aside;

[0029] (2) Extract agarwood with supercritical carbon dioxide for 100 - 300 minutes under the conditions of an extraction temperature of 50 - 65°C, a pressure of 31 - 39 Mpa, and a separation pressure of 6 - 12 Mpa to obtain an agarwood extract;

[0030] (3) Mix, crush vetiver, neroli, lavender, and longan pulp, and then extract with supercritical carbon dioxide for 150 - 240 minutes under the conditions of an extraction temperature of 35 - 37.5°C, a pressure of 29 - 31 Mpa, and a separation pressure of 8 - 10 Mpa to obtain a mixed extract A;

[0031] (4) Mix, crush benzoin, poria, lotus seeds, ganoderma lucidum, ophiopogon japonicus, and polygala tenuifolia, then mix with amber powder, and extract with supercritical carbon dioxide for 180 - 270 minutes under the conditions of an extraction temperature of 42 - 44°C, a pressure of 30 - 36 Mpa, and a separation pressure of 8 - 10 Mpa to obtain a mixed extract B;

[0032] (5) Mix the agarwood extract, mixed extract A, and mixed extract B to prepare a traditional Chinese medicine essential oil composition.

[0033] Furthermore, the preparation method of the traditional Chinese medicine essential oil composition includes:

[0034] (1) Weigh the raw materials according to the selected parts by weight and set aside;

[0035] (2) First extract agarwood with supercritical carbon dioxide for 70 minutes under the conditions of an extraction temperature of 50°C, a pressure of 31 Mpa, and a separation pressure of 6 Mpa, then extract for 95 minutes under the conditions of an extraction temperature of 56°C, a pressure of 35 Mpa, and a separation pressure of 8 Mpa, and then extract for 75 minutes under the conditions of an extraction temperature of 65°C, a pressure of 39 Mpa, and a separation pressure of 12 Mpa to obtain an agarwood extract;

[0036] (3) Mix, crush vetiver, neroli, lavender, and longan pulp, and then extract with supercritical carbon dioxide. First extract for 63 minutes under the conditions of an extraction temperature of 37°C, a pressure of 29 Mpa, and a separation pressure of 8 Mpa, then extract for 63 minutes under the conditions of an extraction temperature of 37.5°C, a pressure of 30 Mpa, and a separation pressure of 10 Mpa, and then extract for 75 minutes under the conditions of an extraction temperature of 35°C, a pressure of 31 Mpa, and a separation pressure of 10 Mpa to obtain a mixed extract A;

[0037] (4) Mix benzoin, poria cocos, lotus seeds, ganoderma lucidum, ophiopogon japonicus, and polygala tenuifolia, crush them, and then mix with amber powder. Extract with supercritical carbon dioxide for 75 minutes under the conditions of an extraction temperature of 44°C, a pressure of 30 Mpa, and a separation pressure of 8 Mpa, extract for 70 minutes under the conditions of an extraction temperature of 44°C, a pressure of 35 Mpa, and a separation pressure of 10 Mpa, and extract for 95 minutes under the conditions of an extraction temperature of 42°C, a pressure of 36 Mpa, and a separation pressure of 10 Mpa to obtain a mixed extract B;

[0038] (5) Mix the agarwood extract, the mixed extract A, and the mixed extract B to prepare a traditional Chinese medicine essential oil composition.

[0039] In a third aspect, the present invention also provides the traditional Chinese medicine essential oil composition described in any one of the above, or the traditional Chinese medicine essential oil composition prepared by the preparation method described in any one of the above;

[0040] Optionally, the traditional Chinese medicine preparation is selected from an oil preparation, a solution, a spray, an emulsion, a cream, a gel, a patch, a tincture, an ointment, a drop, a powder, a liniment, a film-forming agent, a cyclodextrin clathrate, a microcapsule, a microsphere, a liposome, or a dry powder inhaler.

[0041] The emulsion can be a Pickering emulsion, a microemulsion, a nanoemulsion, etc.

[0042] In a fourth aspect, the present invention also provides the application of the traditional Chinese medicine essential oil composition described in any one of the above, or the traditional Chinese medicine essential oil composition prepared by the preparation method described in any one of the above, or the traditional Chinese medicine preparation in the preparation of a drug for preventing and / or treating insomnia.

[0043] In a fifth aspect, the present invention also provides the application of the traditional Chinese medicine essential oil composition described in any one of the above, or the traditional Chinese medicine essential oil composition prepared by the preparation method described in any one of the above, or the traditional Chinese medicine preparation in the preparation of a drug for improving sleep quality and / or prolonging sleep time.

[0044] The technical solution of the present invention has the following advantages:

[0045] 1. The Chinese medicine essential oil composition provided by the present invention comprises the following raw materials: vetiver, benzoin, Polygala, agarwood, bitter orange flower, lavender, longan pulp, Poria, lotus seed, red ganoderma, Ophiopogon and amber. Vetiver, benzoin and Polygala root are the main drugs in the prescription, which lay the keynote of promoting blood circulation and regulating qi, calming the mind and settling the spirit for the overall prescription. Agarwood, Poria and lotus seed are the ministerial drugs, which can warm the middle and promote qi, strengthen the spleen and nourish the heart. Bitter orange flower, lavender, longan pulp, red ganoderma, Ophiopogon and amber are the adjuvant drugs, which have the effects of relaxing, soothing, nourishing qi and blood, nourishing and calming the mind. Among them, Ophiopogon can also regulate the yin and yang balance of the human body, and the blood circulation and diuretic effects of amber are helpful to improve the blood circulation and water metabolism of the body, so that the effect of the prescription is more perfect. All the drugs are used together to play the effect of calming the mind and regulating qi.

[0046] 2. The Chinese medicine essential oil composition provided by the present invention comprises, by weight, the raw materials of the Chinese medicine essential oil composition: 10-20 parts of Vetiver, 10-20 parts of Benzoin, 1-5 parts of Polygala, 5-15 parts of Aquilaria, 0.5-1 parts of Bitter Orange Flower, 0.5-2 parts of Lavender, 5-15 parts of Longan Meat, 10-20 parts of Poria, 10-20 parts of Lotus Seed, 1-5 parts of Ganoderma Lucidum, 1-5 parts of Radix Ophiopogonis and 3-8 parts of Amber. By limiting the proportion of each raw material in the prescription, the synergistic effect between the components can be better exerted, the advantages are enhanced and the disadvantages are avoided, and the best effect of the prescription for treating insomnia is achieved to the greatest extent.

[0047] 3. The Chinese medicinal essential oil composition provided by the present invention also has the following effects:

[0048] (1) Natural and safe: All ingredients are derived from plants. No chemical synthetic ingredients are added during the entire production process. It has no toxic side effects on the human body and is suitable for long-term use. Consumers do not need to worry about health risks.

[0049] (2) Highly effective sleep aid: Through the synergistic effect of multiple plant ingredients, it can regulate the physiological and psychological state of the human body from multiple dimensions. On the one hand, it soothes the nervous system, reduces anxiety and tension, and relaxes the human mind; on the other hand, it significantly improves sleep quality, shortens the time to fall asleep, prolongs deep sleep time, and reduces the number of awakenings at night, allowing users to enjoy better quality and more stable sleep.

[0050] (3) Convenient to use: The original form of the product is essential oil, which can be used in a variety of ways. For example, an aromatherapy machine can be used to diffuse the fragrance, allowing the fragrance to evenly permeate the entire room, creating a comfortable and relaxing sleeping environment; it can also be applied for massage, and absorbed through the skin to achieve the effect of relaxing the body and mind and relieving fatigue, meeting the usage habits and needs of different consumers.

[0051] (4) Environmentally friendly and sustainable: In terms of raw material selection, renewable plant resources are preferentially selected to ensure the sustainable supply of resources; in the preparation process, carbon dioxide, an inert and non-flammable gas, is used as a solvent for extraction, which is harmless to the environment and human body and meets the requirements of modern society for environmental protection and sustainable development.

[0052] (5) Commercial diversification: When commercially developing this product, diversification can be achieved. The essential oil can be made into a spray, added to body wash, made into a lotion or cream by using an emulsifier, or added to a hydrogel for topical application. This creates a huge space for the commercial development of the product.

[0053] 4. Most existing sleep aid products, such as derivatives of lavender and neroli, mainly focus on relaxing and soothing emotions, or can only slightly improve the anxiety and tension of volunteers with severe insomnia. They have little effect on improving the sleep quality of ordinary people. The traditional Chinese medicine essential oil composition of the present invention not only has obvious curative effects on insomnia volunteers, but also has the effect of improving sleep quality for ordinary people (non-insomnia volunteers).

[0054] Although ordinary people are not diagnosed with insomnia, there may be differences in the quality of sleep, such as light sleep and still feeling tired after waking up. However, they do not need to "seek medical treatment" for this, and considering the side effects, there is no need to take sleeping pills. But the use of this product can help them achieve deep sleep from "being able to notice when their roommate turns over" to "not being able to notice when their roommate washes, talks, boils water, etc.".

[0055] The N3 stage is slow-wave sleep, which is important for physical development, muscle regeneration, and the immune system; while the REM stage is important for cognition, memory, and emotions. The traditional Chinese medicine essential oil composition of the present invention can better promote the normal development and maintenance of the overall health status of ordinary people by improving the quality of insomnia. Detailed implementation manners

[0056] The following embodiments are provided to better understand the present invention further. They are not limited to the best implementation manner, and do not limit the content and protection scope of the present invention. Any product that is the same as or similar to the present invention obtained by anyone under the inspiration of the present invention or by combining the features of the present invention with other prior art features falls within the protection scope of the present invention.

[0057] For those not specifying specific experimental steps or conditions in the embodiments, the operations or conditions of the conventional experimental steps described in the literature in this field can be followed. For reagents or instruments not indicating the manufacturer, they are all conventional reagent products that can be obtained through commercial purchase.

[0058] Example 1

[0059] This embodiment provides a traditional Chinese medicine essential oil composition, which includes the following raw materials: 15 g of vetiver, 15 g of benzoin, 3 g of polygala root, 10 g of agarwood, 0.8 g of neroli, 1.5 g of lavender, 10 g of longan pulp, 15 g of poria cocos, 15 g of lotus seeds, 3 g of ganoderma lucidum, 3 g of ophiopogon japonicus, and 4 g of amber.

[0060] The preparation method is as follows:

[0061] (1) Strictly screen various plant raw materials, carefully remove the deteriorated, damaged and parts that do not meet the quality standards, and then conduct in-depth cleaning to remove the dust, impurities and microorganisms on the surface to ensure the purity of the raw materials. Weigh vetiver, benzoin, polygala root, agarwood, neroli, lavender, longan pulp, poria cocos, lotus seeds, ganoderma lucidum, ophiopogon japonicus and amber according to the dosage of each raw material in the above traditional Chinese medicine essential oil composition for standby;

[0062] (2) Crush the agarwood, and after passing through a 70-mesh sieve, extract it with supercritical carbon dioxide for 70 minutes under the conditions of an extraction temperature of 50 °C, a pressure of 31 Mpa, and a separation pressure of 6 Mpa, then extract it for 95 minutes under the conditions of an extraction temperature of 56 °C, a pressure of 35 Mpa, and a separation pressure of 8 Mpa, and then extract it for 75 minutes under the conditions of an extraction temperature of 65 °C, a pressure of 39 Mpa, and a separation pressure of 12 Mpa to obtain an agarwood extract.

[0063] (3) Mix, crush vetiver, neroli, lavender and longan pulp, and after passing through an 85-mesh sieve, extract it with supercritical carbon dioxide for 63 minutes under the conditions of an extraction temperature of 37 °C, a pressure of 29 Mpa, and a separation pressure of 8 Mpa, extract it for 63 minutes under the conditions of an extraction temperature of 37.5 °C, a pressure of 30 Mpa, and a separation pressure of 10 Mpa, and extract it for 75 minutes under the conditions of an extraction temperature of 35 °C, a pressure of 31 Mpa, and a separation pressure of 10 Mpa to obtain a mixed extract A.

[0064] (4) Mix, crush benzoin, poria cocos, lotus seeds, ganoderma lucidum, ophiopogon japonicus, polygala root, and then mix with amber powder. Extract it with supercritical carbon dioxide for 75 minutes under the conditions of an extraction temperature of 44 °C, a pressure of 30 Mpa, and a separation pressure of 8 Mpa, extract it for 70 minutes under the conditions of an extraction temperature of 44 °C, a pressure of 35 Mpa, and a separation pressure of 10 Mpa, and extract it for 95 minutes under the conditions of an extraction temperature of 42 °C, a pressure of 36 Mpa, and a separation pressure of 10 Mpa to obtain a mixed extract B;

[0065] (5) Mix the agarwood extract, the mixed extract A and the mixed extract B to prepare a traditional Chinese medicine essential oil composition.

[0066] Example 2

[0067] This embodiment provides a traditional Chinese medicine essential oil composition, comprising the following raw materials: 18 g of vetiver, 18 g of benzoin, 2 g of polygala root, 8 g of agarwood, 1 g of neroli flower, 1 g of lavender, 8 g of longan pulp, 18 g of poria cocos, 18 g of lotus seed, 2 g of ganoderma lucidum, 2 g of ophiopogon japonicus, and 5 g of amber.

[0068] Its preparation method is the same as that of Example 1.

[0069] Example 3

[0070] This embodiment provides a traditional Chinese medicine essential oil composition, comprising the following raw materials: 10 g of vetiver, 20 g of benzoin, 1 g of polygala root, 15 g of agarwood, 0.5 g of neroli flower, 2 g of lavender, 5 g of longan pulp, 20 g of poria cocos, 10 g of lotus seed, 1 g of ganoderma lucidum, 5 g of ophiopogon japonicus, and 3 g of amber.

[0071] Its preparation method is the same as that of Example 1.

[0072] Example 4

[0073] This embodiment provides a traditional Chinese medicine essential oil composition, comprising the following raw materials: 20 g of vetiver, 10 g of benzoin, 5 g of polygala root, 5 g of agarwood, 1 g of neroli flower, 0.5 g of lavender, 15 g of longan pulp, 10 g of poria cocos, 20 g of lotus seed, 5 g of ganoderma lucidum, 1 g of ophiopogon japonicus, and 8 g of amber.

[0074] Its preparation method is the same as that of Example 1.

[0075] Comparative Example 1

[0076] This comparative example provides a traditional Chinese medicine essential oil composition, comprising the following raw materials: 43 g of sweet almond, 0.8 g of neroli flower, 1.5 g of lavender, 10 g of longan pulp, 15 g of poria cocos, 15 g of lotus seed, and 3 g of ophiopogon japonicus.

[0077] Its preparation method is as follows:

[0078] (1) Strictly screen various plant raw materials, carefully remove the deteriorated, damaged, and non - compliant parts, and then conduct in - depth cleaning to remove the dust, impurities, and microorganisms on the surface to ensure the purity of the raw materials. Weigh the sweet almond, neroli flower, lavender, longan pulp, poria cocos, lotus seed, and ophiopogon japonicus according to the dosage of each raw material in the above traditional Chinese medicine essential oil composition for standby;

[0079] (2) Crush the sweet almonds. After passing through a 70-mesh sieve, use supercritical carbon dioxide to extract for 70 minutes first under the conditions of an extraction temperature of 50 °C, a pressure of 31 Mpa, and a separation pressure of 6 Mpa, then extract for 95 minutes under the conditions of an extraction temperature of 56 °C, a pressure of 35 Mpa, and a separation pressure of 8 Mpa, and then extract for 75 minutes under the conditions of an extraction temperature of 65 °C, a pressure of 39 Mpa, and a separation pressure of 12 Mpa to obtain sweet almond extract.

[0080] (3) Mix, crush the bitter orange flowers, lavender and longan pulp. After passing through an 85-mesh sieve, use supercritical carbon dioxide to extract for 63 minutes first under the conditions of an extraction temperature of 37 °C, a pressure of 29 Mpa, and a separation pressure of 8 Mpa, extract for 63 minutes under the conditions of an extraction temperature of 37.5 °C, a pressure of 30 Mpa, and a separation pressure of 10 Mpa, and extract for 75 minutes under the conditions of an extraction temperature of 35 °C, a pressure of 31 Mpa, and a separation pressure of 10 Mpa to obtain mixed extract A.

[0081] (4) Mix, crush Poria cocos, lotus seeds and Ophiopogon japonicus. After passing through a 70-mesh sieve, mix with amber powder. Use supercritical carbon dioxide to extract for 75 minutes under the conditions of an extraction temperature of 44 °C, a pressure of 30 Mpa, and a separation pressure of 8 Mpa, extract for 70 minutes under the conditions of an extraction temperature of 44 °C, a pressure of 35 Mpa, and a separation pressure of 10 Mpa, and extract for 95 minutes under the conditions of an extraction temperature of 42 °C, a pressure of 36 Mpa, and a separation pressure of 10 Mpa to obtain mixed extract B;

[0082] (5) Mix the sweet almond extract, mixed extract A and mixed extract B to prepare a traditional Chinese medicine essential oil composition.

[0083] Experimental Example 1

[0084] 1. Clinical data

[0085] Recruit 4 insomnia volunteers aged 18 to 65 years old and 4 healthy volunteers. Each group has an equal number of men and women.

[0086] Inclusion criteria for insomnia volunteers: Meeting the diagnostic criteria for insomnia disorder in the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) of the American Academy of Sleep Medicine. Specifically, it is manifested as difficulty falling asleep (sleep latency exceeding 30 minutes), difficulty maintaining sleep (number of nocturnal awakenings ≥ 2 times or early morning awakening), decreased sleep quality (frequent dreams, light sleep, easy to wake up), and the above symptoms lasting for no less than 3 months, occurring at least 3 times a week. All volunteers have normal cognitive functions, can understand and cooperate with the completion of various assessment questionnaires and related examinations, and the Mini-Mental State Examination (MMSE) scale score is within the normal range to ensure that patients can accurately feedback their sleep status and feelings after treatment. Sleep monitoring data: Confirmed by polysomnography (PSG), the sleep efficiency (actual sleep time / time in bed × 100%) is lower than 85%; or the Pittsburgh Sleep Quality Index (PSQI) score ≥ 7 points. This scoring system can comprehensively evaluate the sleep quality of patients in the past 1 month, and the higher the score, the more serious the sleep problem.

[0087] Exclusion criteria for insomnia volunteers: (1) Primary sleep disorders: Exclude similar insomnia symptoms caused by other primary sleep disorders, such as sleep apnea hypopnea syndrome (apnea hypopnea index ≥ 5 times / hour monitored by PSG), restless legs syndrome (with typical leg discomfort and a strong desire to move the legs, the symptoms are relieved after movement and aggravated during night rest), etc.

[0088] (2) Mental illnesses: Currently suffering from severe mental illnesses, such as patients in the acute episode of schizophrenia, bipolar disorder, etc.; or those with severe depression and suicidal tendencies. The insomnia symptoms of such patients may be related to the severity of mental illnesses and complex pathological mechanisms, making it difficult to simply evaluate the treatment effect for insomnia.

[0089] (3) Physical diseases: Exclude insomnia caused by severe physical diseases, such as advanced malignant tumors, severe cardiovascular and cerebrovascular diseases (such as unstable angina, acute cerebral infarction in the acute phase, etc.), liver and kidney failure, etc. The pain, discomfort, etc. during these physical diseases themselves and their treatment processes will significantly interfere with sleep, and the physical condition of patients is unstable and unable to effectively participate in the study.

[0090] (4) Drug and substance abuse: Having used long-acting benzodiazepine drugs (such as chlordiazepoxide, diazepam, etc.) or other psychoactive drugs that may affect sleep assessment within 1 month before screening; or having a history of alcohol, drug, etc. substance abuse and still not completely abstaining within 3 months before screening. The residual effects or withdrawal reactions of drugs and substances may affect the judgment of the treatment effect for insomnia.

[0091] ​(5) Pregnant and lactating women: Women who are pregnant or lactating are excluded because drugs or treatments may have potential adverse effects on the fetus or infant.

[0092] (6) Others: Patients with cognitive impairment or communication disorders who are unable to cooperate with the study-related assessments and examinations; patients who have participated in other clinical trials within the past 3 months to avoid mutual interference between different trials.

[0093] The main complaints of the four insomnia volunteers are as follows: P1: female, 32 years old. Main complaint: "It takes more than 2 hours to fall asleep, I wake up 3-4 times every night, and I can't fall asleep at 4 am. I have headaches, poor concentration, and anxiety during the day." P2: male, 45 years old, main complaint: "Although I can fall asleep quickly, my sleep is very shallow and I wake up at the slightest sound. After getting up in the morning, I feel as tired as if I didn't sleep, and I often take naps during the day." P3: female, 28 years old, main complaint: "I wake up on time at 1 am every day, and I can't fall asleep again. I can only lie down until dawn. I feel weak all over during the day, which affects my work efficiency." P4: male, 38 years old, main complaint: "My sleep is intermittent, I always feel like I'm dreaming, and I feel anxious after waking up. I feel groggy during the day, but I'm afraid I can't fall asleep at night, forming a vicious cycle."

[0094] The ages of the four healthy volunteers are as follows: V1: female, 25 years old. V2: male, 30 years old. V3: female, 27 years old. V4: male, 33 years old.

[0095] 2. Treatment methods

[0096] The eight volunteers underwent multiple sleep experiments before and during the medication treatment (i.e., using a g.tec USBAmplifier to collect EEG during sleep and obtain the sleep time of each sleep stage), and the subjective sleep quality was evaluated using a standardized scale after the sleep experiment.

[0097] 8 volunteers were medicated as follows: 1 ml of the Chinese medicine essential oil composition was taken before going to bed and applied to the neck and nose, the administration frequency was once a day, and they fell asleep after applying. Specifically, 8 volunteers first applied the Chinese medicine essential oil composition prepared in Comparative Example 1 for 3 consecutive days, and after a 2-week washout period, they applied the Chinese medicine essential oil composition prepared in Example 1 for 3 consecutive days. After each application of the Chinese medicine essential oil composition, the electrodes of the USB Amplifier were placed in the corresponding positions before falling asleep (the specific operation steps and electrode placement positions are shown in the evaluation indicators below), and after each test, the volunteers used the following standardized scales to evaluate the subjective sleep quality: Visual Analog Scale (VAS), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI).

[0098] 3. Evaluation Metrics

[0099] (1) Operating steps based on g.tec USBAmplifier

[0100] Channel selection: Select a 16-channel electroencephalogram system. The hybrid active electrodes are placed at 8 positions, namely F3, F4, C3, C4, O1, O2, P3, and P4 according to the 10-20 system for electroencephalogram recording. At the same time, additional electrooculogram (EOG) channels, including the left eye (LO) and the right eye (RO), and an electromyogram (EMG) channel (submental muscle position) are set up to measure muscle tension through EMG. Sampling rate setting: Set the sampling rate to 1200 Hz, which can capture signal details more accurately. Signal preprocessing - filtering operation: Apply a band-pass filter of 0.5 - 40 Hz to filter the collected data to effectively remove interference signals outside the specific frequency range. Artifact removal: Carefully exclude artifacts caused by electromyogram interference (such as interference caused by blinking and swallowing) and electrode drift through professional algorithms and manual review to ensure the accuracy of the data. Manual staging - time segment analysis: Analyze in units of 30-second epochs according to the standard process. Mark the sleep stage for each 30-second time period according to relevant industry standards to accurately evaluate the sleep state.

[0101] (2) After collecting sleep electroencephalogram signals using g.tec USBAmplifier, organize and distinguish the N1, N2, N3, and REM sleep stages based on electroencephalogram signal characteristics (frequency, amplitude, waveform) and in combination with sleep staging criteria (such as the AASM guidelines). Thus, analyze the data of total sleep time (TST), each sleep stage (N1, N2, N3, REM), and wake after sleep onset (WASO). The N1 stage is the stage between sleep and wakefulness, N2 is light sleep, N3 is slow-wave sleep also known as deep sleep, and REM is rapid eye movement. When "evaluating" the sleep situation, the duration of N3 and REM reflects the quality of sleep.

[0102] Among them, the period before treatment is recorded as the baseline period, the treatment period when applying the traditional Chinese medicine essential oil composition of Comparative Example 1 is recorded as the placebo period, and the treatment period when applying the traditional Chinese medicine essential oil composition of Example 1 is recorded as the intervention period.

[0103] (3) After each sleep test, the volunteers will use the following standardized scales to evaluate subjective sleep quality: Visual Analogue Scale (VAS), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI): used to evaluate insomnia symptoms.

[0104] 4. Experimental results

[0105] Through repeated measures analysis of variance, the total sleep time (TST) and the deep sleep stage (N3, i.e., slow wave sleep SWS) during the intervention period were prolonged to varying degrees, and the number and duration of awakenings during sleep were significantly reduced, improving the continuity of sleep. Moreover, the VAS score decreased significantly, indicating that the subjective sleep quality of the volunteers improved; the ESS score decreased significantly, meaning that daytime sleepiness was alleviated; and the ISI score also decreased significantly, indicating that the insomnia symptoms of the volunteers were relieved.

[0106] From the experimental results, it can be seen that the essential oil of Comparative Example 1 did not show an obvious improvement effect on the insomnia group, while compared with Comparative Example 1, the traditional Chinese medicine essential oil composition provided in the examples of the present invention had a significantly improved curative effect on the insomnia group. Moreover, the traditional Chinese medicine essential oil composition provided in the examples of the present application had an obvious effect on both insomnia volunteers and healthy volunteers, with strong universality.

[0107] Table 1 Insomnia Volunteers

[0108]

[0109]

[0110] * indicates p < 0.05 compared with the baseline period data, # indicates p < 0.05 compared with the placebo period data, ↑ indicates an increase, and ↓ indicates a decrease.

[0111] Table 2 Healthy Volunteers

[0112]

[0113] * indicates p < 0.05 compared with the baseline period data, # indicates p < 0.05 compared with the placebo period data, ↑ indicates an increase, and ↓ indicates a decrease.

[0114] Table 3 Comparison of Subjective Scales (Insomnia Volunteers vs Healthy Volunteers)

[0115]

[0116]

[0117] In the table, ↓ indicates a decrease.

[0118] Among them, the experimental results of the placebo period and the intervention period in Tables 1 - 3 are the experimental data on the first day of applying the traditional Chinese medicine essential oil composition. After testing, there are no obvious differences in the experimental results of each group on the first day and the following two days.

[0119] Obviously, the above embodiments are merely examples given for clear illustration and are not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or alterations can be made based on the above description. It is not necessary and impossible to enumerate all the implementation manners here. And the obvious changes or alterations derived therefrom still fall within the protection scope of the present invention.

Claims

1. A Chinese medicine essential oil composition, characterized in that, The raw materials of the traditional Chinese medicine essential oil composition include: vetiver, benzoin, polygala, agarwood, bitter orange flower, lavender, longan pulp, tuckahoe, lotus seed, red ganoderma, ophiopogon and amber.

2. The Chinese medicinal essential oil composition according to claim 1, characterized in that The raw materials of the traditional Chinese medicine essential oil composition include 10-20 parts of vetiver, 10-20 parts of benzoin, 1-5 parts of polygala, 5-15 parts of agarwood, 0.5-1 parts of bitter orange flower, 0.5-2 parts of lavender, 5-15 parts of longan pulp, 10-20 parts of poria, 10-20 parts of lotus seeds, 1-5 parts of red ganoderma, 1-5 parts of ophiopogon and 3-8 parts of amber by weight.

3. The Chinese medicinal essential oil composition according to claim 2, characterized in that, The raw materials of the Chinese medicine essential oil composition include, by weight: 15 parts of vetiver, 15 parts of benzoin, 3 parts of polygala, 10 parts of agarwood, 0.8 parts of bitter orange flower, 1.5 parts of lavender, 10 parts of longan pulp, 15 parts of tuckahoe, 15 parts of lotus seeds, 3 parts of red ganoderma, 3 parts of ophiopogon and 4 parts of amber; or, The raw materials of the Chinese medicine essential oil composition include: 18 parts of vetiver, 18 parts of benzoin, 2 parts of polygala, 8 parts of agarwood, 1 part of bitter orange flower, 1 part of lavender, 8 parts of longan pulp, 18 parts of tuckahoe, 18 parts of lotus seeds, 2 parts of red ganoderma, 2 parts of ophiopogon and 5 parts of amber; or, The raw materials of the Chinese medicine essential oil composition include: 10 parts of vetiver, 20 parts of benzoin, 1 part of polygala, 15 parts of agarwood, 0.5 parts of bitter orange flower, 2 parts of lavender, 5 parts of longan pulp, 20 parts of tuckahoe, 10 parts of lotus seeds, 1 part of red ganoderma, 5 parts of ophiopogon and 3 parts of amber; or, The raw materials of the Chinese medicine essential oil composition include: 20 parts of vetiver, 10 parts of benzoin, 5 parts of polygala, 5 parts of agarwood, 1 part of bitter orange flower, 0.5 parts of lavender, 15 parts of longan pulp, 10 parts of tuckahoe, 20 parts of lotus seeds, 5 parts of red ganoderma, 1 part of ophiopogon and 8 parts of amber.

4. According to any one of claims 1 to 3, the Chinese medicinal essential oil composition is characterized in that: The Chinese herbal medicine essential oil composition comprises an extract obtained by extracting the raw material by a conventional extraction method; Optionally, the conventional extraction method includes one or more of supercritical carbon dioxide extraction, distillation, solvent extraction, cold pressing, microwave-assisted method, ultrasound-assisted method, and enzyme-assisted method.

5. A method for preparing the Chinese medicinal essential oil composition according to any one of claims 1 to 4, characterized in that: The method comprises the following steps: weighing vetiver, benzoin, polygala, agarwood, bitter orange flower, lavender, longan pulp, tuckahoe, lotus seed, red ganoderma, ophiopogon and amber according to selected weight proportions, mixing and extracting according to a conventional extraction method or extracting respectively according to a conventional extraction method and then mixing to obtain the product.

6. The method for preparing the Chinese medicine essential oil composition according to claim 5, wherein The conventional extraction method includes one or more of supercritical carbon dioxide extraction, distillation, solvent extraction, cold pressing, microwave-assisted extraction, ultrasonic-assisted extraction, and enzyme-assisted extraction.

7. The method for preparing the Chinese medicine essential oil composition according to claim 6, wherein The preparation method of the Chinese medicine essential oil composition comprises: (1) weighing the raw materials according to the selected weight parts and setting aside; (2) extracting the agarwood with supercritical carbon dioxide at an extraction temperature of 50-65° C., a pressure of 31-39 MPa, and a separation pressure of 6-12 MPa for 100-300 minutes to obtain an agarwood extract; (3) mixing and crushing vetiver, bitter orange flower, lavender and longan pulp, and extracting them with supercritical carbon dioxide at an extraction temperature of 35-37.5° C., a pressure of 29-31 MPa and a separation pressure of 8-10 MPa for 150-240 minutes to obtain a mixed extract A; (4) mixing and crushing benzoin, Poria cocos, lotus seeds, Ganoderma lucidum, Ophiopogon japonicus, and Polygala tenuifolia with amber powder, and extracting with supercritical carbon dioxide at an extraction temperature of 42-44° C., a pressure of 30-36 MPa, and a separation pressure of 8-10 MPa for 180-270 minutes to obtain a mixed extract B; (5) The agarwood extract, the mixed extract A and the mixed extract B are mixed to prepare a Chinese medicine essential oil composition.

8. The method for preparing the Chinese medicine essential oil composition according to claim 7, wherein The preparation method of the Chinese medicine essential oil composition comprises: (1) weighing the raw materials according to the selected weight parts and setting aside; (2) extracting the agarwood with supercritical carbon dioxide at an extraction temperature of 50° C., a pressure of 31 MPa, and a separation pressure of 6 MPa for 70 minutes, then extracting at an extraction temperature of 56° C., a pressure of 35 MPa, and a separation pressure of 8 MPa for 95 minutes, and then extracting at an extraction temperature of 65° C., a pressure of 39 MPa, and a separation pressure of 12 MPa for 75 minutes to obtain an agarwood extract; (3) Vetiver, bitter orange flower, lavender and longan pulp are mixed and crushed, and then extracted with supercritical carbon dioxide at an extraction temperature of 37° C., a pressure of 29 MPa and a separation pressure of 8 MPa for 63 minutes, at an extraction temperature of 37.5° C., a pressure of 30 MPa and a separation pressure of 10 MPa for 63 minutes, and at an extraction temperature of 35° C., a pressure of 31 MPa and a separation pressure of 10 MPa for 75 minutes to obtain a mixed extract A; (4) mixing and crushing benzoin, tuckahoe, lotus seed, red ganoderma, ophiopogon japonicus, and polygala tenuifolia with amber powder, extracting with supercritical carbon dioxide at an extraction temperature of 44° C., a pressure of 30 MPa, and a separation pressure of 8 MPa for 75 minutes, extracting at an extraction temperature of 44° C., a pressure of 35 MPa, and a separation pressure of 10 MPa for 70 minutes, and extracting at an extraction temperature of 42° C., a pressure of 36 MPa, and a separation pressure of 10 MPa for 95 minutes to obtain a mixed extract B; (5) The agarwood extract, the mixed extract A and the mixed extract B are mixed to prepare a Chinese medicine essential oil composition.

9. A Chinese medicine preparation, characterized in that: A Chinese medicinal essential oil composition comprising any one of claims 1 to 4 or a Chinese medicinal essential oil composition prepared by the preparation method of any one of claims 5 to 8; Optionally, the Chinese medicine preparation is selected from oils, solutions, sprays, emulsions, creams, gels, patches, tinctures, ointments, drops, powders, liniments, coatings, cyclodextrin inclusion compounds, microcapsules, microspheres, liposomes or dry powder inhalers.

10. Use of the Chinese medicinal essential oil composition described in any one of claims 1 to 4, or the Chinese medicinal essential oil composition prepared by the preparation method described in any one of claims 5 to 8, or the Chinese medicinal preparation described in claim 9 in the preparation of a medicament for preventing and / or treating insomnia.

11. Use of a Chinese medicinal essential oil composition as described in any one of claims 1 to 4, a Chinese medicinal essential oil composition obtained by the preparation method as described in any one of claims 5 to 8, or a Chinese medicinal preparation as described in claim 9 in the preparation of a medicine for improving sleep quality and / or prolonging sleep time.

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