Essential oil capable of soothing nerves and helping sleep and preparation method of essential oil
Through scientific formulation and precise extraction, the calming and sleep-aiding essential oil utilizes natural plant ingredients such as jojoba oil and sweet almond oil to form a four-fold synergistic mechanism. This solves the problems of arbitrary formulation and uncertain efficacy of existing calming and sleep-aiding essential oils, achieving highly effective and safe sleep improvement.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-03-09
- Publication Date
- 2026-04-17
AI Technical Summary
Existing calming and sleep-aiding essential oil formulas are highly arbitrary, lack synergistic effects of ingredients, and lack scientific proportions and process optimization, resulting in uncertain efficacy and issues related to safety and dependence with long-term use.
Using natural plant extracts, this calming and sleep-aiding essential oil is prepared through scientific formulation and precise extraction methods. It contains ingredients such as jojoba oil, sweet almond oil, and silver fir oil. The dosage and ingredient ratio are controlled by processes such as steam distillation and cold pressing to form a four-fold synergistic mechanism (nerve calming, mood soothing, neurotransmitter regulation, and autonomic nervous system balance) to improve insomnia.
It achieves a comprehensive, multi-target synergistic mechanism, rapidly improving symptoms such as difficulty falling asleep and frequent awakenings, enhancing the stability and persistence of sleep quality, avoiding the side effects of chemical drugs, and ensuring the safety and efficacy of long-term use.
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Abstract
Description
Technical Field
[0001] This invention belongs to the field of medicine, specifically relating to a calming and sleep-aiding essential oil and its preparation method. Background Technology
[0002] Insomnia, difficulty falling asleep, light sleep, frequent awakenings, vivid dreams, and morning fatigue are common sleep disorders among modern people. These disorders are caused by a variety of factors, including mental stress, anxiety, environmental disturbances, and physiological dysfunction. Long-term sleep disorders can lead to a series of physical and mental health problems, such as decreased immunity, memory loss, and irritability, which seriously affect the quality of life.
[0003] Currently, methods to improve sleep mainly include Western medicine treatment, traditional Chinese medicine conditioning, and psychological intervention, but each also has some shortcomings.
[0004] Although Western medicines such as benzodiazepines have a fast onset of action, long-term use can easily lead to dependence, drug resistance, and side effects such as dizziness and drowsiness.
[0005] Traditional Chinese medicine treatment requires diagnosis and treatment based on syndrome differentiation, and its effects are relatively slow and its taste is not good, resulting in low patient compliance.
[0006] Psychological intervention is limited by professional resources and individual cooperation.
[0007] Essential oils, as an important form of external treatment in Traditional Chinese Medicine, act on the body through inhalation, application, and aromatherapy. They offer advantages such as gentleness, convenience, and minimal side effects, complementing conventional treatments and aiding sleep. However, existing calming and sleep-aiding essential oils on the market suffer from problems such as arbitrary formulations, insufficient synergistic effects of ingredients, and uncertain efficacy. There is a lack of scientifically formulated and optimized essential oils. For example, lavender essential oil has a single mechanism of action, failing to provide comprehensive sleep aid effects, and lacks experimentally verified safety thresholds. Therefore, developing a calming and sleep-aiding essential oil with natural ingredients, a scientifically formulated recipe, and significant efficacy is of significant practical importance. Summary of the Invention
[0008] The purpose of this invention is to provide a calming and sleep-aiding essential oil and its preparation method. The essential oil uses natural plant extracts and achieves the effects of calming the mind and aiding sleep by regulating the nervous system and soothing emotions. It is safe, non-addictive, and suitable for long-term use.
[0009] To achieve the above objectives, the technical solution of the present invention is as follows: A calming and sleep-aiding essential oil comprises the following components in parts by weight: jojoba oil 55-70 parts, sweet almond oil 30-50 parts, silver fir essential oil 0.5-1.0 parts, Atlantic cedarwood essential oil 0.5-1.0 parts, mimosa flower essential oil 0.5-1.0 parts, bergamot essential oil 0.5-1.0 parts, Australian eucalyptus essential oil 0.5-1.0 parts, and vetiver / vetiver essential oil 0.5-1.0 parts. 0 parts, 0.1-0.5 parts lavender essential oil, 0.1-0.5 parts Australian sandalwood essential oil, 0.5-1.0 parts rosewood essential oil, 0.5-1.0 parts bitter orange leaf essential oil, 0.05-0.1 parts chamomile essential oil, 0.05-0.2 parts neroli essential oil, 0.01-0.05 parts magnolia essential oil, 0.2-0.6 parts benzoin essential oil, and 0.3-0.8 parts jasmine essential oil.
[0010] The method for preparing the calming and sleep-aiding essential oil of the present invention includes the following steps: a. Take equal masses of Cathaya argyrophylla, Atlantic cedar, Australian eucalyptus, vetiver / vetiver, lavender, Australian sandalwood, rosewood, petitgrain, neroli, chamomile, magnolia, benzoin, and jasmine. Clean them and crush them separately to obtain corresponding plant solid fragments. Use steam distillation to extract each plant solid fragment separately. Filter the extracted products and collect the filtrate to obtain Cathaya argyrophylla essential oil, Atlantic cedar essential oil, Australian eucalyptus essential oil, vetiver / vetiver essential oil, lavender essential oil, Australian sandalwood essential oil, rosewood essential oil, petitgrain essential oil, neroli essential oil, chamomile essential oil, magnolia essential oil, benzoin essential oil, and jasmine essential oil. b. Take mimosa flowers of equal mass to those in step a), clean them, and extract them using a cold pressing method to obtain mimosa flower essential oil. The temperature during the extraction process is controlled at 5-10℃. c. Take sweet almonds of equal mass to those in step a), remove the shells, wash and grind them into a paste. Heat at 60-80℃ to extract the oil. Remove the solvent by distillation and then perform de-mucilage, de-acidification and decolorization treatments. Finally, perform high-temperature vacuum distillation, filter the extracted product and collect the filtrate to obtain sweet almond oil. The vacuum distillation temperature is 240-280℃. d. Take jojoba seeds of equal mass to those in step a), clean them, and extract jojoba oil by cold pressing. The cold pressing pressure should be controlled at 20-30 MPa, the temperature at 40-60℃, and the extraction time at 30-60 minutes. e. Take equal weights of bergamot peel from each of the raw materials in step a), clean them, and extract them using a cold pressing method to obtain bergamot essential oil. The temperature during the extraction process is controlled at 5-10℃. f. Mix the above-obtained Cathaya argyrophylla essential oil, Atlantic cedarwood essential oil, Australian eucalyptus essential oil, vetiver / vetiver essential oil, lavender essential oil, Australian sandalwood essential oil, rosewood essential oil, bitter orange leaf essential oil, neroli essential oil, chamomile essential oil, magnolia essential oil, mimosa essential oil, bergamot essential oil, sweet almond essential oil, and jojoba essential oil according to the above ingredients.
[0011] Preferably, in step a), when extracting the essential oils of each plant using steam distillation, the mass ratio of water to plant solid fragments is 4-6:1, and more preferably, the mass ratio of water to mimosa flower solid fragments is 5-6:1.
[0012] Preferably, the crops used for extracting essential oils are all organic crops.
[0013] People with insomnia have reduced tolerance to environmental stimuli (such as emotions and stress) in their central nervous system, making them prone to a state of "nervous tension." The calming and sleep-aiding essential oil described in this invention contains: Lavender essential oil contains linalool and linalyl acetate, which can inhibit central nervous system excitation through the olfactory pathway and reduce nerve sensitivity. Experimental studies have found that adding lavender essential oil to this application can reduce excessive discharge of the cerebral cortex and alleviate the problem of "the brain not stopping when falling asleep".
[0014] Australian sandalwood essential oil (0.2-0.5 parts) contains santalol, which gently calms the nerves and can slowly regulate nerve excitability, avoiding rebound awakening caused by excessive stimulation. It is suitable for people with sensitive insomnia.
[0015] Chronic insomnia is often accompanied by anxiety, which in turn worsens insomnia, creating a vicious cycle. Atlantic cedarwood essential oil (0.6-1.0 parts) contains cedrol, which can inhibit the overactivation of the hypothalamic-pituitary-adrenal (HPA) axis, reduce cortisol (stress hormone) secretion, and alleviate pre-sleep anxiety and tension. Benzoin essential oil contains benzyl benzoate, which can relieve muscle tension and calm the central nervous system; bergamot essential oil's citronellal component can transmit olfactory signals to the limbic system (emotional center), promoting the release of neurotransmitters related to pleasure and improving the common problem of "depressed mood or irritability" in people with insomnia.
[0016] People with insomnia commonly have abnormal neurotransmitter regulation. Orange blossom essential oil contains methyl anthranilate, which can promote the secretion of serotonin precursors by the hypothalamus, indirectly increasing melatonin synthesis and improving "difficulty falling asleep and poor sleep maintenance". Jasmine essential oil contains benzyl alcohol and linalool, which promote the production of serotonin precursors and relieve anxiety. The active ingredients in mimosa flower essential oil can inhibit the excessive activation of dopamine receptors, reduce nerve excitability, and reduce symptoms of "frequent awakenings and vivid dreams at night".
[0017] People with insomnia often experience an imbalance between sympathetic nerve excitation and parasympathetic nerve inhibition (manifested as rapid heart rate and muscle tension). Vetiver essential oil, containing vetiverol, can regulate the autonomic nervous system through the vagus nerve, promoting parasympathetic nerve excitation and relieving muscle tension; petitgrain essential oil contains linalool, which can reduce heart rate variability and improve the physiological discomfort of "pre-sleep palpitations and body tension"; chamomile essential oil has a soothing effect on the nerves and reduces anxiety, which can help regulate the balance of the autonomic nervous system and further enhance the relaxation effect.
[0018] The dosage of each component in the calming and sleep-aiding essential oil described in this invention needs to be strictly controlled, mainly based on the tolerance of insomniacs to the essential oil components, the onset threshold, and the safety of long-term use, to avoid stimulation due to excessive dosage or ineffectiveness due to insufficient dosage.
[0019] Lavender essential oil can soothe nerves and promote relaxation. The amount of lavender essential oil added should be controlled between 0.1 and 0.5 parts. Low doses (0.1 to 0.2 parts) are suitable for people with mild insomnia, as they relax nerves through their gentle aroma. Medium to high doses (0.3 to 0.5 parts) are for moderate to severe insomnia, which enhances the central inhibitory effect without exceeding the safety threshold, thus avoiding excessive sedation that may lead to drowsiness the next day.
[0020] Australian sandalwood essential oil has a calming and soothing effect. The amount added should be controlled at 0.1-0.5 parts. Its fat-soluble components take effect slowly but last for a long time. The medium dose (0.3 parts) is suitable for people with insomnia to "maintain sleep" and avoid waking up at night; the high dose (0.5 parts) is designed for people with long-term insomnia to improve their nerve tolerance and enhance the calming effect.
[0021] People with insomnia have a lower tolerance for stimulating ingredients. While neroli essential oil can regulate mood, high doses may cause dizziness. In essential oil blends, neroli essential oil should be controlled at 0.05-0.2 parts to achieve its "anxiety-relieving" effect without overstimulating sensitive nerves. Magnolia essential oil has a long-lasting aroma but is highly active. Adding a small amount (0.01-0.05 parts) can help improve sleep depth without interfering with the respiratory center, making it especially suitable for people with insomnia and respiratory sensitivity. Chamomile essential oil should be added at 0.05-0.1 parts to gently soothe nerves while avoiding irritation to the respiratory tract and skin.
[0022] The base oils are refined jojoba oil (50-70 parts) and refined sweet almond oil (30-50 parts). Since the skin and mucous membranes (such as the nasal cavity) of insomniacs may be in a sensitive state due to long-term anxiety, refined jojoba oil and refined sweet almond oil are used as base oils. The low allergenicity and high permeability of refined jojoba oil reduce the risk of irritation from direct contact with mucous membranes. Sweet almond oil contains vitamin E, which can soothe dry skin caused by nervous tension (such as the "pre-sleep itching" common in insomniacs), improve comfort, and indirectly aid relaxation, thus promoting sleep.
[0023] This invention utilizes a scientifically formulated blend of various essential oils with synergistic effects. It can not only quickly improve symptoms such as difficulty falling asleep and frequent awakenings, but also regulate the nervous system as a whole, achieving a synergistic effect of "soothing, calming, and promoting sleep," thereby enhancing the stability and duration of sleep quality.
[0024] The four-target synergistic mechanism of the calming and sleep-aiding essential oil described in this invention: - Hypersensitivity of the nerves: Lavender essential oil reduces electrical activity in the cerebral cortex.
[0025] - Emotional anxiety: Bergamot essential oil + cedarwood essential oil to reduce cortisol.
[0026] - Neurotransmitter regulation: Orange blossom essential oil + mimosa essential oil increase 5HT and decrease DA.
[0027] - Autonomic nervous system: Vetiver essential oil + bitter orange leaf essential oil + chamomile essential oil reduce sleep fragmentation.
[0028] This invention employs precisely tailored extraction methods for different plant materials.
[0029] Silver fir, Atlantic cedar, Australian eucalyptus, vetiver / vetiver, lavender, Australian sandalwood, rosewood, bitter orange leaf, orange blossom, chamomile, magnolia, etc. are treated with steam distillation, with the water-to-solid-plant fragment mass ratio strictly controlled at 4-6:1.
[0030] The mimosa flowers are cold-pressed, with the temperature controlled at 5-10℃, to retain the volatile aroma components and active substances to the maximum extent.
[0031] Sweet almond oil is purified through extraction at specific temperatures (60-80℃) and high-temperature vacuum distillation (240-280℃); refined jojoba oil is stabilized through cold pressing, hydrolysis, and fractionation (25-30 trays, reflux index 2-9).
[0032] The beneficial effects of this invention are: The essential oils of this invention achieve a comprehensive, multi-target synergistic mechanism: the formula is not a single essential oil or a simple combination, but rather intervenes in the physiological and psychological causes of insomnia through a four-pronged synergistic pathway (nerve calming, mood soothing, neurotransmitter regulation, and autonomic nervous system balance), forming a synergistic effect of "soothing-calming-sleep-aiding," thereby improving the stability and persistence of sleep quality. This invention designs the dosage range for each essential oil based on its specific function, avoiding arbitrary formulation and ensuring the stability and predictability of therapeutic effects.
[0033] All ingredients in this invention are plant extracts, containing no chemically synthesized drugs, thus reducing the risk of adverse reactions from the source. It improves sleep through natural pathways of nerve regulation and mood soothing, avoiding the dependence, drug resistance, and side effects such as drowsiness and dizziness commonly found in Western medicines like benzodiazepines.
[0034] This invention employs appropriate extraction methods and precise processes to extract essential oils from different plant materials, ensuring the activity of the effective components, improving product purity and stability, and guaranteeing therapeutic efficacy. Clear ranges are defined for key steps (such as distillation temperature, pressure, time, and water-to-material ratio) to ensure process reproducibility and provide a reliable basis for industrial production. Detailed Implementation
[0035] Example 1: A method for preparing a calming and sleep-aiding essential oil, comprising the following steps: a. Take 100g each of the following plants: Cathaya argyrophylla, Atlantic cedarwood, Australian eucalyptus, vetiver / vetiver, lavender, Australian sandalwood, rosewood, petitgrain, neroli, chamomile, magnolia, benzoin, and jasmine. Clean them and crush them separately to obtain corresponding plant solid fragments. Extract each plant solid fragment separately using steam distillation. Filter the extracted products and collect the filtrates to obtain Cathaya argyrophylla essential oil, Atlantic cedarwood essential oil, Australian eucalyptus essential oil, vetiver / vetiver essential oil, lavender essential oil, Australian sandalwood essential oil, rosewood essential oil, petitgrain essential oil, neroli essential oil, chamomile essential oil, magnolia essential oil, benzoin essential oil, and jasmine essential oil. The mass ratio of water to plant solid fragments during the extraction process is 4:1. b. Take 100g of mimosa flowers, wash them clean, and extract them using the cold pressing method. During the extraction process, the temperature is controlled at 5℃ to obtain mimosa flower essential oil. c. Take 100g of sweet almonds, remove the shells, wash and crush them into a paste. Heat at 60℃ to extract the oil. Remove the solvent by distillation and then de-mucilage, de-acidification and decolorization. Finally, perform high-temperature vacuum distillation at 240℃. Filter the extracted product and collect the filtrate to obtain sweet almond essential oil. d. Take 100g of jojoba seeds, wash them clean, and extract jojoba oil using the cold pressing method. The cold pressing pressure is controlled at 20MPa, the temperature is 40℃, and the extraction time is 30 minutes. e. Mix 50 parts of jojoba essential oil, 30 parts of sweet almond oil, 1 part of silver fir essential oil, 1 part of Atlantic cedarwood essential oil, 1 part of mimosa essential oil, 1 part of bergamot essential oil, 1 part of Australian eucalyptus essential oil, 0.5 parts of vetiver essential oil, 0.5 parts of lavender essential oil, 0.5 parts of Australian sandalwood essential oil, 0.5 parts of rosewood essential oil, 0.5 parts of bitter orange leaf essential oil, 0.1 parts of chamomile essential oil, 0.2 parts of neroli essential oil, 0.05 parts of magnolia essential oil, 0.2 parts of benzoin essential oil, and 0.3 parts of jasmine essential oil to obtain the essential oil.
[0036] Example 2: A method for preparing a calming and sleep-aiding essential oil, comprising the following steps: a. Take 150g each of the following plants: Cathaya argyrophylla, Atlantic cedarwood, Australian eucalyptus, vetiver / vetiver, lavender, Australian sandalwood, rosewood, petitgrain, neroli, chamomile, magnolia, benzoin, and jasmine. Clean them and crush them separately to obtain corresponding plant solid fragments. Extract each plant solid fragment separately using steam distillation. Filter the extracted products and collect the filtrates to obtain Cathaya argyrophylla essential oil, Atlantic cedarwood essential oil, Australian eucalyptus essential oil, vetiver essential oil, lavender essential oil, Australian sandalwood essential oil, rosewood essential oil, petitgrain essential oil, neroli essential oil, benzoin essential oil, jasmine essential oil, and mimosa essential oil. The mass ratio of water to plant solid fragments during the extraction process is 5:1. b. Take 150g of Albizia julibrissin flowers, wash them clean, and extract them using the cold pressing method. During the extraction process, the temperature is controlled at 8℃ to obtain bergamot essential oil. c. Take 150g of sweet almonds, remove the shells, wash and crush them into a paste. Heat at 70℃ to extract the oil. Remove the solvent by distillation and then perform de-mucilage, de-acidification and decolorization treatments. Finally, perform high-temperature vacuum distillation at 260℃. Filter the extracted product and collect the filtrate to obtain refined sweet almond essential oil. d. Take 150g of jojoba seeds, wash them clean, and extract jojoba oil using the cold pressing method. The cold pressing pressure is controlled at 25MPa, the temperature is 50℃, and the extraction time is 45 minutes. e. Mix 60 parts of jojoba essential oil, 40 parts of sweet almond oil, 0.8 parts of silver fir essential oil, 0.8 parts of Atlantic cedarwood essential oil, 0.8 parts of mimosa essential oil, 0.8 parts of bergamot essential oil, 0.8 parts of Australian eucalyptus essential oil, 0.3 parts of vetiver essential oil, 0.3 parts of lavender essential oil, 0.3 parts of Australian sandalwood essential oil, 0.3 parts of rosewood essential oil, 0.3 parts of bitter orange leaf essential oil, 0.08 parts of chamomile essential oil, 0.15 parts of neroli essential oil, 0.03 parts of magnolia essential oil, 0.4 parts of benzoin essential oil, and 0.5 parts of jasmine essential oil to obtain the essential oil.
[0037] Example 3: A method for preparing a calming and sleep-aiding essential oil, comprising the following steps: a. Take 200g each of the following plants: Cathaya argyrophylla, Atlantic cedarwood, Australian eucalyptus, vetiver / vetiver, lavender, Australian sandalwood, rosewood, petitgrain, neroli, chamomile, magnolia, benzoin, and jasmine. Clean them and crush them separately to obtain corresponding plant solid fragments. Extract each plant solid fragment separately using steam distillation. Filter the extracted products and collect the filtrates to obtain Cathaya argyrophylla essential oil, Atlantic cedarwood essential oil, Australian eucalyptus essential oil, vetiver essential oil, lavender essential oil, Australian sandalwood essential oil, rosewood essential oil, petitgrain essential oil, neroli essential oil, benzoin essential oil, jasmine essential oil, and mimosa essential oil. The mass ratio of water to plant solid fragments during the extraction process is 6:1. b. Take 200g of Albizia julibrissin flowers, wash them clean, and extract them using the cold pressing method. During the extraction process, the temperature is controlled at 10℃ to obtain bergamot essential oil. c. Take 200g of sweet almonds, remove the shells, wash and crush them into a paste. Heat at 80℃ to extract the oil. Remove the solvent by distillation and then de-mucilage, de-acidification and decolorization. Finally, perform high-temperature vacuum distillation at 280℃. Filter the extracted product and collect the filtrate to obtain refined sweet almond essential oil. d. Take 200g of jojoba seeds, wash them clean, and extract jojoba oil using the cold pressing method. The cold pressing pressure is controlled at 30MPa, the temperature is 60℃, and the extraction time is 60 minutes. e. Mix 70 parts of jojoba essential oil, 50 parts of sweet almond oil, 0.5 parts of silver fir essential oil, 0.5 parts of Atlantic cedarwood essential oil, 0.5 parts of mimosa flower essential oil, 0.5 parts of bergamot essential oil, 0.5 parts of Australian eucalyptus essential oil, 0.1 parts of vetiver essential oil, 0.1 parts of lavender essential oil, 0.1 parts of Australian sandalwood essential oil, 0.1 parts of rosewood essential oil, 0.1 parts of bitter orange leaf essential oil, 0.05 parts of chamomile essential oil, 0.05 parts of neroli essential oil, 0.01 parts of magnolia essential oil, 0.6 parts of benzoin essential oil, and 0.8 parts of jasmine essential oil to obtain the essential oil.
[0038] Comparative Example 1 The difference from Embodiment 1 of this invention is that Australian sandalwood essential oil was not added. The raw material composition of each component of the essential oil includes: 50 parts jojoba essential oil, 30 parts sweet almond oil, 1 part silver fir essential oil, 1 part Atlantic cedarwood essential oil, 1 part mimosa essential oil, 1 part bergamot essential oil, 1 part Australian eucalyptus essential oil, 0.5 parts vetiver essential oil, 0.5 parts lavender essential oil, 0.5 parts rosewood essential oil, 0.5 parts bitter orange leaf essential oil, 0.2 parts neroli essential oil, 0.1 parts chamomile essential oil, 0.05 parts magnolia essential oil, 0.2 parts benzoin essential oil, and 0.3 parts jasmine essential oil.
[0039] Comparative Example 2 The difference from Embodiment 1 of the present invention is that Atlantic cedarwood essential oil and bergamot essential oil are missing. The raw material composition of each component of the essential oil includes: 50 parts of jojoba essential oil, 30 parts of sweet almond oil, 1 part of silver fir essential oil, 1 part of mimosa essential oil, 1 part of Australian eucalyptus essential oil, 0.5 parts of vetiver essential oil, 0.5 parts of lavender essential oil, 0.5 parts of Australian sandalwood essential oil, 0.5 parts of rosewood essential oil, 0.5 parts of bitter orange leaf essential oil, 0.2 parts of neroli essential oil, 0.1 parts of chamomile essential oil, 0.05 parts of magnolia essential oil, 0.4 parts of benzoin essential oil, and 0.5 parts of jasmine essential oil.
[0040] Comparative Example 3 The difference from Embodiment 1 of the present invention is that orange blossom essential oil and mimosa essential oil are missing. The raw material composition of each component of the essential oil includes: 50 parts jojoba essential oil, 30 parts sweet almond oil, 1 part silver fir essential oil, 1 part Atlantic cedarwood essential oil, 1 part bergamot essential oil, 1 part Australian eucalyptus essential oil, 0.5 parts vetiver essential oil, 0.5 parts lavender essential oil, 0.5 parts Australian sandalwood essential oil, 0.5 parts rosewood essential oil, 0.5 parts bitter orange leaf essential oil, 0.1 parts chamomile essential oil, 0.05 parts magnolia essential oil, 0.6 parts benzoin essential oil, and 0.8 parts jasmine essential oil.
[0041] Comparative Example 4 The difference from Embodiment 1 of the present invention is that vetiver essential oil and bitter orange leaf essential oil are missing. The raw material composition of each component of the essential oil includes: 50 parts jojoba essential oil, 30 parts sweet almond oil, 1 part silver fir essential oil, 1 part Atlantic cedarwood essential oil, 1 part mimosa essential oil, 1 part bergamot essential oil, 1 part Australian eucalyptus essential oil, 0.5 parts lavender essential oil, 0.5 parts Australian sandalwood essential oil, 0.5 parts rosewood essential oil, 0.2 parts neroli essential oil, 0.1 parts chamomile essential oil, 0.05 parts magnolia essential oil, 0.2 parts benzoin essential oil, and 0.3 parts jasmine essential oil.
[0042] Comparative Example 5 The difference from Embodiment 1 of the present invention is that the magnolia essential oil and chamomile essential oil are missing. The raw material composition of each component of the essential oil includes: 50 parts jojoba essential oil, 30 parts sweet almond oil, 1 part silver fir essential oil, 1 part Atlantic cedarwood essential oil, 1 part mimosa essential oil, 1 part bergamot essential oil, 1 part Australian eucalyptus essential oil, 0.5 parts vetiver essential oil, 0.5 parts lavender essential oil, 0.5 parts Australian sandalwood essential oil, 0.5 parts rosewood essential oil, 0.5 parts bitter orange leaf essential oil, 0.2 parts neroli essential oil, 0.2 parts benzoin essential oil, and 0.3 parts jasmine essential oil.
[0043] I. Animal Experiments 1. Animal model preparation, drug administration, and monitoring 1.1 Animal selection and rearing conditions Strain and specifications: SPF grade ICR mice (specific pathogen-free grade), 6-8 weeks old, half male and half female, weighing 18-22g.
[0044] Husbandry environment: All mice were housed in separate cages (5 mice per cage, same sex). The temperature in the housing was controlled at 22-25℃ and the relative humidity at 50%-60%. A 12-hour light-dark cycle was adopted (lighting time 7:00-19:00). They were allowed free access to standard mouse feed and sterile drinking water. Cages and bedding were changed twice a week. The mice were allowed to acclimatize for 3 days before the experiment to eliminate the interference of environmental stress on the experimental results.
[0045] Sample size determination basis: Referring to the "Guideline for Estimating Sample Size in Laboratory Animal Science", and combined with the preliminary experimental results (the standard deviation of the sleep duration of mice after PCPA modeling was 8.2 min, the expected difference between the experimental group and the model group was ≥15 min, α=0.05, β=0.2), the sample size was calculated using the formula n=2×(Zα / 2+Zβ)²×σ² / δ². Each group required at least 8 mice. To avoid the impact of modeling failure or accidental death on the data, 10 mice were actually set in each group to ensure statistical power.
[0046] 1.2 Animal Model Preparation (PCPA-Induced Insomnia Model) 1.2.1 Preparation of Modeling Drugs Preparation of PCPA suspension: Weigh PCPA powder (purity ≥98%, purchased from Sigma-Aldrich), add 0.5% sodium carboxymethyl cellulose (CMC-Na) solution (solvent is sterile physiological saline), stir magnetically for 30 min until uniformly suspended, and prepare a suspension with a concentration of 90 mg / mL (prepare immediately and leave at room temperature for no more than 2 h), ensuring that each milliliter of suspension contains 90 mg of PCPA, meeting the requirement of "gavage volume of 5 mL / kg at a dose of 450 mg / kg" (the routine single gavage volume for mice is ≤10 mL / kg to avoid gastrointestinal damage).
[0047] Preparation of sodium pentobarbital solution: Weigh sodium pentobarbital powder (purity ≥99%, purchased from Shanghai Yuanye Biotechnology), prepare a 4.5 mg / mL solution with sterile physiological saline, store at 4℃ protected from light, and warm to room temperature before use to avoid repeated freeze-thaw cycles affecting efficacy.
[0048] 1.1.2 Modeling Operation Process Grouping and Baseline Recording: After the acclimatization period, mice were randomly divided into four groups using a random number table: normal control group, PCPA (parachlorophenylalanine, insomnia modeling drug) group, basal oil only group (blank control), diazepam positive drug group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, and Comparative Example 5 group, with 10 mice in each group. Animals in each group were housed separately. Before the experiment, the baseline weight and spontaneous activity frequency (number of squares traversed within 3 minutes) of all mice were recorded to ensure no statistically significant differences between groups (P>0.05).
[0049] PCPA Intraperitoneal Injection Modeling: Except for the normal control group, all other groups of mice underwent intraperitoneal injection (IP): PCPA suspension was drawn up with a 1 mL sterile syringe (No. 4 needle), the mice were fixed with their abdomens facing upwards (the thumb and index finger of the left hand were used to fix the mouse's shoulder, and the ring finger was used to fix the abdomen), the needle was inserted at a 30° angle to the abdominal skin (avoiding the bladder and liver), and the drug was slowly injected at a dose of 450 mg / kg, once a day for 2 consecutive days (fixed at 10:00 am); the normal control group was injected with an equal volume of physiological saline, and the operation method was the same.
[0050] Model establishment verification: 0.5 hours after intraperitoneal injection of ipPCPA on day 2, administer ip sodium pentobarbital (45 mg / kg). Observe the duration of sleep in mice (i.e., from the disappearance to the recovery of the righting reflex). A decrease of more than 30% in total sleep time within 24 hours indicates successful modeling. Criteria for the loss of righting reflex: If a mouse is placed supine on a flat table and cannot roll over to a prone position on its own within 1 minute, the righting reflex is considered to be lost. Criteria for righting reflex recovery: If a mouse can maintain its prone position for more than 5 minutes without lying on its back again, it is considered that the righting reflex has recovered.
[0051] 1.3 Administration Method Following the second intraperitoneal PCPA (IP), the positive control group received diazepam tablets (0.92 mg / kg) via intragastric administration (ig). Groups 1, 2, 3, 1 (Comparative Example), 2 (Comparative Example), 3 (Comparative Example), 4 (Comparative Example), and 5 (Comparative Example) received corresponding intraperitoneal sleep-aid essential oils (doses of 1.67 g / kg, 3.34 g / kg, 6.68 g / kg, 1.67 g / kg, 1.67 g / kg, 1.67 g / kg, 1.67 g / kg, and 1.67 g / kg, respectively). The base oil-only group received an intraperitoneal administration of a base oil containing 50 parts refined jojoba oil and 30 parts refined sweet almond oil (dosage 1.67 g / kg). The normal control group and the PCPA model group received the same volume of normal saline (NS) via intraperitoneal administration (ig) once daily for 7 consecutive days.
[0052] 1.4 Monitoring Indicators and Detection Methods 1.4.1 Weight monitoring (dynamic assessment of mouse physiological status) Monitoring tools and frequency: The mice were weighed daily at 8:00 AM on an electronic balance (fasting for 2 hours before weighing, with free access to water) for 7 consecutive days. During the recording, the bedding and feces on the surface of the mice were removed to ensure data accuracy.
[0053] Abnormal handling: If a mouse loses more than 10% of its body weight for two consecutive days, or exhibits abnormalities such as lethargy or ruffled fur, it should be immediately isolated for observation to rule out the influence of disease or drug toxicity. If necessary, the experiment should be terminated and an autopsy performed.
[0054] 1.4.2 Measurement of sleep duration Measurement time and operation: 60 minutes after gavage on the 6th day of drug administration (to ensure drug absorption), all mice were intraperitoneally injected with sodium pentobarbital solution (45 mg / kg). A "blind observation" method was used (the observer did not know the group of mice). The righting reflex was recorded every 5 minutes, accurate to the second, and the sleep duration was calculated. If the sleep duration of a mouse exceeded 360 minutes, it was recorded as 360 minutes (to avoid the risk of death caused by sodium pentobarbital overdose).
[0055] Data correction: If more than two mice in the same group have abnormal sleep duration (exceeding the mean ± 2 standard deviations within the group), the mice in that group need to be retested to exclude operational errors.
[0056] 1.4.3 Behavioral tests (open field test, to assess autonomic nervous system and emotional state) a. Experimental setup and environment Open field box specifications: Customized acrylic open field box (50cm×50cm×30cm), the bottom surface is divided into 25 10cm×10cm squares with a black marker, a high-definition camera is installed on the top of the box and connected to behavioral analysis software; the test environment is kept quiet (noise ≤50dB) and the lighting intensity is 200 lux.
[0057] b. Testing Process 1. Adaptation period: 60 minutes after gavage on the 7th day of administration, mice were placed in a transparent observation box outside the open field box for 5 minutes to adapt and reduce stress from unfamiliar environment.
[0058] 2. Testing period: Place the mice in the center square of the open field box, immediately start the camera and software, and record behavioral indicators within 3 minutes: Horizontal activity score: When a mouse crosses an adjacent square more than 3 times, it is counted as 1 time. The software automatically counts the total number of squares crossed. Vertical activity score: The mouse's forelimbs leaving the ground (hindlimbs standing) is counted once. The software recognizes when the height of the forelimbs raised is greater than or equal to 1 / 2 of the body height. Modification activity score: The number of times the mouse performed grooming, ear scratching, cheek scratching, and other cleaning behaviors was manually recorded, and the number of fecal particles within 3 minutes was counted. The sum of the two was the modification activity score.
[0059] c. Cleaning and Repetition: After each mouse is tested, wipe the inner wall and bottom of the open field box with 75% ethanol. Wait for the ethanol to evaporate before testing the next mouse to avoid residual odor affecting the behavior of subsequent mice.
[0060] 1.4.4 Detection of monoamine neurotransmitters in brain tissue a. Sample collection and processing 1. Sacrifice and tissue collection: 24 hours after the last administration, mice were anesthetized by intraperitoneal injection of 10% chloral hydrate solution (3 mL / kg). After the corneal reflex disappeared, the mice were quickly decapitated. The hippocampus and brainstem tissues were separated on an ice table. The surface bloodstains were rinsed with pre-cooled physiological saline, the moisture was absorbed with filter paper, and the mice were immediately placed in liquid nitrogen for flash freezing (≥10 min). They were then transferred to an ultra-low temperature freezer at -80℃ for storage.
[0061] 2. Preparation of tissue homogenate: Take 50 mg each of frozen hippocampus and brainstem tissue, add 1 mL of pre-cooled 0.1 mol / L hydrochloric acid solution (containing 0.1 mmol / L EDTA-2Na to prevent neurotransmitter oxidation), homogenize using a tissue homogenizer (12000 rpm) in an ice bath for 30 s, pause for 30 s, repeat 3 times to prepare a homogenate; centrifuge the homogenate at 4℃ and 12000 rpm for 15 min, take the supernatant, filter through a 0.22 μm organic phase filter membrane, place the filtrate in a sample vial, and store at 4℃ in the dark until detection.
[0062] b. High-performance liquid chromatography-electrochemical detection (HPLC-ECD) Instruments and reagents: High performance liquid chromatograph (Shimadzu LC-20AD), electrochemical detector (ECD-3000), chromatographic column (Shim-pack VP-ODS C18 column, 4.6 mm × 150 mm, 5 μm); mobile phase was "0.1 mol / L potassium dihydrogen phosphate solution (containing 0.02 mmol / L EDTA-2Na, pH adjusted to 3.0 with phosphoric acid): methanol = 85:15 (v / v)", flow rate 1.0 mL / min, column temperature 30℃, detection potential +0.7 V.
[0063] Standard curve and quantification: Prepare a mixed solution of standards for NE (norepinephrine), DOPAC (dihydroxyphenylacetic acid), DA (dopamine), HIAA (5-hydroxyindoleacetic acid), HVA (homovanillic acid), and 5-HT (serotonin) (concentration gradient 0.1, 0.5, 1, 5, 10, 50 ng / mL), inject 20 μL, and plot the standard curve (R). 2 ≥0.999); 20 μL of sample was injected, and the concentration of each neurotransmitter was calculated based on the peak area (unit: ng / g tissue). Each sample was tested three times, and the average value was taken.
[0064] 1.4.5 Serum cortisol detection (validation of the target of mood anxiety) a. Serum collection Simultaneously with brain tissue collection, after anesthetizing mice, blood was collected from the posterior orbital venous plexus using capillary tubes (0.5–1 mL per mouse), placed in a coagulation-promoting tube, and allowed to stand at room temperature for 30 minutes to allow the blood to coagulate. The blood was then centrifuged at 4°C and 3000 rpm for 10 minutes, and the supernatant serum was collected, aliquoted into 0.5 mL centrifuge tubes, and stored at -80°C to avoid repeated freeze-thaw cycles.
[0065] b. Detection methods Serum cortisol concentration was detected using enzyme-linked immunosorbent assay (ELISA) with a mouse cortisol ELISA kit, strictly following the kit instructions. 1. Standard dilution: Dilute the cortisol standard to a gradient concentration of 0, 2, 4, 8, 16, and 32 ng / mL using the reagent kit's diluent; 2. Sample addition and incubation: Add 50 μL each of standard and serum sample (1:10 dilution) to the microplate, then add 50 μL of enzyme-labeled antibody, and incubate at 37°C for 60 min; 3. Washing and color development: Wash the microplate 5 times with washing solution (immersion for 30 seconds each time), pat dry, add 100 μL of substrate solution, and incubate at 37°C in the dark for 15 min; 4. Measurement: Add 50 μL of stop solution and measure the absorbance (OD value) of each well using an ELISA reader (wavelength 450 nm) within 10 min. Calculate the serum cortisol concentration (unit: ng / mL) based on the standard curve.
[0066] Quality control and data management 1. Experimental repeatability control: The same batch of experiments is performed by the same operator. SOPs (Standard Operating Procedures) are established for key steps such as gavage, weighing, and behavioral observation to avoid human error. One quality control sample (a mixed standard of neurotransmitters with known concentrations) is set up for each batch of experiments to ensure the accuracy of the test results.
[0067] 2. Data Recording and Statistics: All raw data (weight, sleep duration, behavioral indicators, and detection concentration) were recorded in an electronic data acquisition spreadsheet (Excel), with the experimental date, operator, and instrument number noted. Data statistics were performed using SPSS 26.0 software. Quantitative data were expressed as mean ± standard deviation (x̄ ± s), and one-way ANOVA was used for comparisons between groups.
[0068] 2 Experimental Results 2.1 Effects of sleep-aiding essential oils on sleep duration and behavior in insomnia-prone mice Table 1 Note: n=10, xˉ±s; compared with the PCPA model group, * represents P<0.05, ** represents P<0.01; compared with the normal group, * represents P<0.05, ** represents P<0.01. As shown in Table 1, compared with the PCPA model group, the sleep duration in the positive drug group and the groups of Example 1, Example 2, and Example 3 was significantly prolonged (P<0.05 or P<0.01). Furthermore, the sleep duration tended to increase with increasing dosage of the calming and sleep-aiding essential oil, indicating that the essential oil has a clear sedative-hypnotic effect. The increase in sleep duration in the high-dose group was close to that in the positive drug group. The sleep duration in Comparative Examples 1-5 and the base oil-only group was not significantly prolonged (P>0.05) and was significantly shorter than that in Example 1-2 groups (P<0.05).
[0069] Compared with the normal control group, the horizontal and vertical activity scores of the PCPA model group, the base oil-only group, and Comparative Examples 1-4 were significantly reduced (P<0.01); the horizontal and vertical activity scores of Comparative Example 5 were slightly improved (P<0.05), but still lower than those of the Example group. Compared with the PCPA model group, the horizontal and vertical activity scores of the positive drug group, Example 2 group, Example 3 group, and Comparative Example 5 were significantly increased (P<0.05 or P<0.01), while there was no significant difference in Example 1 group; there was no significant improvement in Comparative Examples 1-4 and the base oil-only group (P>0.05). There were no significant differences in modification activity scores among the groups.
[0070] 2.2 Effects of sleep-aiding essential oils on monoamine neurotransmitters and cortisol in the brain tissue of insomnia mice. The experimental results are shown in Table 2 (hippocampus) and Table 3 (brainstem).
[0071] Table 2 Note: n=10, xˉ±s; compared with the PCPA model group, ** represents P<0.01; compared with the normal group, # represents P<0.05, ## represents P<0.01. Table 3 Note: n=10, xˉ±s; compared with the PCPA model group, ** represents P<0.01; compared with the normal group, ** represents P<0.05, and ** represents P<0.01. Comparison between Embodiment 1 of the present invention and Comparative Examples 1 to 5: "Serum cortisol level detection" (to specifically verify the regulatory effect of "Atlantic cedar + bergamot" on the target of mood and anxiety), the specific indicators are as follows: Sleep duration measurement: 60 minutes after administration by gavage on the 6th day, mice in each group were injected intraperitoneally with sodium pentobarbital (45 mg / kg), and the time from the disappearance to the recovery of the righting reflex was recorded to evaluate the sedative and hypnotic effect of the essential oil. Behavioral tests: 60 minutes after gavage on day 7 of drug administration, the horizontal activity score, vertical activity score, and modified activity score of mice within 3 minutes were recorded using the open field test to assess the autonomic nervous system and activity status of the mice. Neurotransmitter detection: 24 hours after the last administration, mice were anesthetized and sacrificed, and the hippocampus and brainstem tissues were quickly harvested. The contents of monoamine neurotransmitters such as NE (norepinephrine), DA (dopamine), and 5-HT (5-hydroxytryptamine) in the tissues were determined using a high performance liquid chromatography-electrochemical detection system. Cortisol detection: 24 hours after the last administration, mouse serum was collected to detect cortisol levels, verifying the inhibitory effect of "Atlantic Cedar + Bergamot" on excessive activation of the HPA axis. The detection indicators are shown in Table 4. Table 4 As can be seen from Table 4, Verification of indivisibility: The vertical activity score (9.20) of the group lacking Australian sandalwood essential oil (Comparative Example 1) was close to that of the PCPA model group (vertical activity score of 8.70 in the PCPA group in Table 1), indicating that the lack of Australian sandalwood caused autonomic dysfunction in mice, verifying its core necessity.
[0072] The hippocampal 5-HT content (289.56 ng / g) in the comparative group 3 (orange blossom and mimosa flower missing group) was only 62.6% of that in the example group 1, proving that this combination is the key to neurotransmitter regulation and that the absence of it cannot effectively increase 5-HT levels; all indicators of the base oil group were close to those of the PCPA model group, further verifying that essential oil components are a necessary condition for achieving sleep-aiding effects.
[0073] Synergy verification: The serum cortisol level in Comparative Group 2 (lacking Atlantic cedar + bergamot) (72.9 ng / mL) was significantly higher than that in Example 1 (45.2 ng / mL), indicating that the absence of this combination could not inhibit the overactivation of the HPA axis and the failure of the target for mood anxiety, demonstrating the synergistic regulatory effect of the two on stress hormones.
[0074] The vertical activity score of the comparative group 4 (the group lacking vetiver + bitter orange leaf) (9.80) was only 59% of that of the group in Example 1, demonstrating that the combination synergistically promotes parasympathetic nerve excitation and improves muscle tension, and that the autonomic balance could not be maintained after its absence.
[0075] The improvement effects of all indicators in the five comparative groups (the group lacking magnolia and chamomile) were weaker than those in the first example group, indicating that the synergistic effect of chamomile essential oil and other ingredients is of great significance in improving the sleep-aiding effect.
[0076] II. Population Experiment 1. Experimental Design Eighty patients with sudden hearing loss and sleep disorders admitted to the Department of Otolaryngology at Zhejiang Provincial Hospital of Traditional Chinese Medicine between March and July 2024 were randomly divided into four groups of 20 patients each: control group, estazolam group, lavender essential oil group, and example group.
[0077] Control group: No additional intervention was used.
[0078] Estazolam group: once every night, half an hour before bedtime.
[0079] Lavender essential oil group: 3 times daily, 2 during the day (4 hours apart), and 1 before bedtime, for a total of 2 courses of treatment. Daytime intervention method: Use an aromatherapy diffuser. Add 5 drops of the prepared essential oil to 20mL of purified water in the diffuser. This allows the essential oil molecules to diffuse more fully into the air and be better inhaled by the patient. Each inhalation lasts 30 minutes. Bedtime intervention method: The third inhalation is at 20:00 daily (before bedtime). The operator puts 2 drops of the prepared essential oil onto each of two moistened, defatted cotton balls, placing them 20cm away from the patient's nose. The patient takes 10 deep, slow breaths and relaxes. Then, place the two cotton balls at opposite ends of the patient's pillowcase and remove them the next morning.
[0080] Example Group: Using the essential oil described in Example 1, the intervention course was as follows: 3 times a day, 2 times during the daytime with a 4-hour interval between the two inhalations, and 1 time before bedtime; 1 week constitutes 1 course of treatment, and a total of 2 courses of treatment were administered. The method of use was the same as that of the lavender essential oil group.
[0081] Evaluation Indicator: Pittsburgh Sleep Quality Index (PSQI). The PSQI was the subjective indicator collection tool for this study. It used 19 self-report items to calculate the sum of scores for sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep disorders, hypnotic medication use, and daytime dysfunction. The total PSQI score was calculated, and sleep quality was determined based on the PSQI rating. Test results are shown in Table 5.
[0082] Table 5 As shown in Table 5, the Pittsburgh Sleep Quality Index (PSQI) scores of the four groups of patients before intervention were not statistically different (P>0.05) according to one-way ANOVA.
[0083] Within-group data showed that after 2 weeks of intervention, the PSQI score in the control group remained essentially unchanged (difference of only 0.1 points); the estazolam group, lavender essential oil group, and the example group all showed significant improvement compared to before the intervention, and the intra-group comparisons were all statistically significant (P<0.05). The inter-group comparison results are shown in Table 6.
[0084] Table 6 As shown in Table 6, after 2 weeks of intervention, one-way ANOVA of the PSQI scores of the four groups showed statistically significant differences between groups (P<0.05). The intergroup comparison results indicated that the estazolam group showed the best improvement, with the PSQI score decreasing to 5.8. The improvement in the example group was similar to that of the estazolam group, with a PSQI score difference of only 0.4 points between the two groups, which was not statistically significant (P>0.05). Although the lavender essential oil group showed improvement, the effect was weaker than that of the estazolam group and the example group; all intergroup comparisons showed statistically significant differences (P<0.05).
[0085] 2. Examples and Comparative Analysis 2.1 Experimental subjects and grouping Inclusion criteria strictly followed the population experiment logic described above: meeting the diagnostic criteria for primary insomnia in the "Guidelines for the Diagnosis and Treatment of Insomnia Disorders in China", having a PSQI score of 12-15 (moderate insomnia), not using any sleep aids in the past month, and excluding those with skin allergies, respiratory sensitivities, or serious underlying diseases.
[0086] 2.2 Group Design and Intervention Program Example 1 Group (Positive Control): The whole component essential oil of Example 1 was used for intervention. The intervention method was the same as described above (aromatherapy 3 times a day, 2 times during the day with an interval of 4 hours, and once before going to sleep; during the day, 20mL of purified water was added to an aromatherapy diffuser and 5 drops of essential oil were inhaled for 30 minutes; before going to sleep, 2 drops of essential oil were put on a moistened cotton ball, held 20cm away from the nostrils, and inhaled deeply 10 times before placing it on both ends of the pillowcase). The intervention period was 2 weeks. The core verification goal was to provide a reference for the baseline efficacy.
[0087] Comparative Example 1 (lacking Australian sandalwood essential oil): The essential oil used in the comparative example was used for intervention. The other intervention methods and cycles were the same as those in Example 1. The core verification objective was to verify the indivisibility of Australian sandalwood essential oil in "maintaining sleep continuity".
[0088] Comparative Example 3 (lacking neroli essential oil and mimosa essential oil): The essential oils of Comparative Example 3 were used for intervention. The other intervention methods and cycles were the same as those of Example 1. The core verification objective was to verify the synergistic effect of this combination on "improving difficulty falling asleep and reducing nighttime awakenings".
[0089] Comparative Example 4 (lacking vetiver essential oil and bitter orange leaf essential oil): The essential oils of Comparative Example 4 were used for intervention. The other intervention methods and cycles were the same as those of Example 1. The core verification objective was to verify the synergistic effect of this combination on "relieving muscle tension and improving sleep fragmentation".
[0090] Lavender oil-only group: The intervention consisted of "0.5 parts lavender essential oil + 50 parts refined jojoba essential oil + 30 parts refined sweet almond oil". The other intervention methods and cycles were the same as those in the original Example 1 group. The core verification goal was to compare the therapeutic differences between single essential oil and multi-essential oil combination and highlight the synergistic advantages.
[0091] Blank control group: The intervention was performed using only an aromatherapy diffuser to diffuse purified water. All other intervention methods and cycles were the same as those in the original Example 1 group. The core verification goal was to eliminate the placebo effect and confirm the actual therapeutic effect of the essential oil components.
[0092] Key indicators: The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality before and 2 weeks after the intervention. The total score and scores for six dimensions, namely sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep disorders, and daytime dysfunction, were calculated, consistent with the scoring criteria mentioned above.
[0093] Secondary indicators: Sleep latency (time from preparing to fall asleep to actually falling asleep) and number of awakenings per night were recorded in patients' sleep logs; changes in anxiety before and after the intervention were assessed using the Self-Rating Anxiety Scale (SAS) to verify the effect of essential oils on improving anxiety associated with insomnia. Test results are shown in Table 7. Table 7 Analysis of the results in Table 7: Indivisibility verification: The PSQI reduction (2.5 points) of Comparative Example 1 (lacking Australian sandalwood essential oil) was only 41.7% of that of Example 1, and the number of nighttime awakenings (2.1 times / night) was close to that of the blank control group (2.8 times / night), proving that Australian sandalwood essential oil is indispensable for "maintaining sleep continuity and reducing nighttime awakenings". The sleep latency of Comparative Group 3 (lacking neroli essential oil and mimosa essential oil) (58.9 min) was significantly longer than that of Example 1 (28.5 min), indicating that the absence of this combination could not effectively promote the synthesis of 5-HT and melatonin, and the symptoms of difficulty falling asleep could not be improved, thus verifying its indivisibility.
[0094] Synergistic verification: The PSQI reduction of the group in Example 1 (6.0 points) was significantly higher than that of the lavender oil-only group (3.3 points), and the improvement in sleep latency, number of nighttime awakenings and SAS score was also better, proving that the therapeutic effect of the "multi-essential oil combination" through the synergistic effect of four targets is far superior to that of a single essential oil. The PSQI reduction (2.3 points) of the comparative group 4 (lacking vetiver essential oil and bitter orange leaf essential oil) was only 38.3% of that of the original example group 1. The problem of sleep fragmentation was not effectively alleviated, which reflects the synergistic effect of the combination in "balancing the autonomic nervous system and reducing sleep fragmentation", and further verifies the necessity of multi-component synergy. The improvement effects of all indicators in the five comparative groups (lacking magnolia essential oil and chamomile essential oil) were not as good as those in the first example group, indicating that chamomile essential oil plays an important role in synergistically improving sleep and relieving anxiety, and its combination with other ingredients is indispensable.
[0095] III. Specific Cases Case 1: A young female patient with insomnia Age: 28 Course of illness: Primary insomnia for 6 months, without any systematic treatment. Key symptoms: prolonged sleep latency (60-120 minutes), 2-3 awakenings per night, time to fall back asleep after waking up >30 minutes, accompanied by persistent dizziness and general weakness during the day, PSQI score of 13.2, meeting the diagnostic criteria for moderate insomnia.
[0096] Intervention Program and Effect Verification Intervention method: Using the essential oil of Example 1 of this invention, a standardized aromatherapy intervention was implemented: 30 minutes before bedtime each night, 2 drops of essential oil were added to a special aromatherapy diffuser and atomized at a rate of 300 ml / h for 30 minutes, for 14 consecutive days.
[0097] Key indicator changes: Before intervention: PSQI total score was 13.2 (3 points for sleep onset time, 3 points for sleep disorder, and 2 points for daytime dysfunction). After intervention: PSQI total score dropped to 6.5 (1 point for sleep onset time dimension, 1 point for sleep disorder dimension, and 0 points for daytime dysfunction dimension); Key improvements: Sleep latency was shortened to <30 minutes, the number of nighttime awakenings was ≤1, daytime function returned to normal, and there were no adverse reactions such as skin irritation or respiratory discomfort during the intervention period.
[0098] Case 2: Stress-induced insomnia in a middle-aged man Age: 45 Course of illness: Chronic insomnia for 1 year, directly related to long-term work stress. Core symptoms: Disrupted sleep structure (light sleep phase >60%), significant dreaming, actual sleep time 4-5 hours / night, sleep efficiency <60%, obvious morning fatigue, attention span score (MMSE) 26, PSQI score 12.8.
[0099] Intervention Program and Effect Verification Intervention method: The essential oil of Example 2 of this invention was applied and the intervention was carried out according to the standardized procedure: 2 drops of essential oil were added to the aromatherapy device at 20:30 every day, and the aroma was released by ultrasonic atomization technology (frequency 1.7MHz). The effect time was 30 minutes, and the intervention was carried out continuously for 14 days.
[0100] Key indicator changes: Before intervention: PSQI total score was 12.8 (3 points for sleep quality, 2 points for sleep duration, and 3 points for sleep efficiency). After intervention: PSQI total score dropped to 5.9 (1 point for sleep quality dimension, 1 point for sleep duration dimension, and 2 points for sleep efficiency dimension). Key improvements: Sleep efficiency increased to >85%, actual sleep time extended to 6-7 hours, light sleep period decreased to <40%, MMSE score improved to 29 points, and there was no risk of drug dependence or adverse neurological reactions.
[0101] Case 3: Sleep Maintenance Disorders in Elderly Women Age: 62 Disease course: Sleep maintenance disorder for 2 years, accompanied by mild anxiety. Key symptoms: poor sleep continuity (sleep fragmentation index > 5 times / hour), sensitivity to environmental noise, difficulty falling back asleep after waking up at night, PSQI score of 14.0, and Pittsburgh sleep log showing continuous sleep time of < 4 hours.
[0102] Intervention Program and Effect Verification Intervention method: Using the essential oil of Example 3 (modified) of this invention, individualized aromatherapy intervention was implemented: the aromatherapy parameters were adjusted based on the physiological characteristics of the elderly, the intervention was started at 21:00 every night, the amount of essential oil used was 2 drops, the aromatherapy device was placed at a height of 1.2m, and the effective radius was 1.5m, and the intervention was carried out continuously for 14 days.
[0103] Key indicator changes: Before intervention: PSQI total score was 14.0 (3 points for sleep onset time, 3 points for sleep efficiency, and 3 points for sleep disorder). After intervention: PSQI total score dropped to 6.8 (1 point for sleep onset time, 2 points for sleep efficiency, and 1 point for sleep disorder). Key improvements: Sleep fragmentation index decreased to <2 times / hour, continuous sleep time increased to more than 6 hours, and the Self-Rating Anxiety Scale (SAS) score decreased from 52 points before intervention to 38 points, verifying the synergistic calming and soothing effect of the modified essential oil.
[0104] The three typical cases mentioned above cover insomnia patients of different ages and disease courses. Through standardized application of the calming and sleep-aiding essential oil of this invention for aromatherapy intervention, all patients achieved a reduction of ≥40% in PSQI score, significant improvement in core sleep indicators (sleep latency, number of awakenings, and sleep efficiency), and no adverse reactions occurred. This fully demonstrates the effectiveness and safety of the modified calming and sleep-aiding essential oil in the intervention of sleep disorders.
Claims
1. A calming and sleep-aiding essential oil, characterized in that, The product comprises the following ingredients by weight: 55-70 parts jojoba oil, 30-50 parts sweet almond oil, 0.5-1.0 parts silver fir essential oil, 0.5-1.0 parts Atlantic cedarwood essential oil, 0.5-1.0 parts mimosa flower essential oil, 0.5-1.0 parts bergamot essential oil, 0.5-1.0 parts Australian eucalyptus essential oil, 0.5-1.0 parts vetiver / vetiver essential oil, 0.1-0.5 parts lavender essential oil, 0.1-0.5 parts Australian sandalwood essential oil, 0.5-1.0 parts rosewood essential oil, 0.5-1.0 parts bitter orange leaf essential oil, 0.05-0.1 parts chamomile essential oil, 0.05-0.2 parts neroli essential oil, 0.01-0.05 parts magnolia essential oil, 0.2-0.6 parts benzoin essential oil, and 0.3-0.8 parts jasmine essential oil.
2. The method for preparing the calming and sleep-aiding essential oil as described in claim 1, characterized in that, Includes the following steps: a. Take equal masses of Cathaya argyrophylla, Atlantic cedar, Australian eucalyptus, vetiver / vetiver, lavender, Australian sandalwood, rosewood, petitgrain, neroli, chamomile, magnolia, benzoin, and jasmine. Clean them and crush them separately to obtain corresponding plant solid fragments. Use steam distillation to extract each plant solid fragment separately. Filter the extracted products and collect the filtrate to obtain Cathaya argyrophylla essential oil, Atlantic cedar essential oil, Australian eucalyptus essential oil, vetiver / vetiver essential oil, lavender essential oil, Australian sandalwood essential oil, rosewood essential oil, petitgrain essential oil, neroli essential oil, chamomile essential oil, magnolia essential oil, benzoin essential oil, and jasmine essential oil. b. Take mimosa flowers of equal mass to those in step a), clean them, and extract them using a cold pressing method to obtain mimosa flower essential oil. The temperature during the extraction process is controlled at 5-10℃. c. Take sweet almonds of equal mass to those in step a), remove the shells, wash and crush them into a paste. Heat at 60-80℃ to extract the oil. Remove the solvent by distillation and then perform de-mucilage, de-acidification and decolorization treatments. Finally, perform high-temperature vacuum distillation, filter the extracted product and collect the filtrate to obtain sweet almond oil. The vacuum distillation temperature is 240-280℃. d. Take jojoba seeds of equal mass to those in step a), clean them, and extract jojoba oil by cold pressing. The cold pressing pressure should be controlled at 20-30 MPa, the temperature at 40-60℃, and the extraction time at 30-60 minutes. e. Take equal weights of bergamot peel from each of the raw materials in step a), clean them, and extract them using a cold pressing method to obtain bergamot essential oil. The temperature during the extraction process is controlled at 5-10℃. f. Mix the above-obtained silver fir essential oil, Atlantic cedar essential oil, Australian eucalyptus essential oil, vetiver / vetiver essential oil, lavender essential oil, Australian sandalwood essential oil, rosewood essential oil, bitter orange leaf essential oil, neroli essential oil, chamomile essential oil, magnolia essential oil, mimosa flower essential oil, bergamot essential oil, refined sweet almond essential oil, and refined jojoba essential oil according to the ingredients described in claim 1.
3. The preparation method according to claim 2, characterized in that, In step a), when extracting the essential oils of each plant using steam distillation, the mass ratio of water to plant solid fragments is 4-6:1, preferably 5-6:
1.
4. The preparation method according to claim 2, characterized in that, The crops used to extract essential oils are all organic crops.