A composition helpful for improving sleep function, its preparation method and uses

Abstract

The present invention provides a composition helpful for improving sleep function, which is prepared from raw materials in the following weight ratios: 1-5 parts of cedar essential oil, 1-3 parts of frankincense essential oil, 0.5-2 parts of dalbergia odorifera essential oil, 0.5-2 parts of nutmeg essential oil, 0.3-1 part of costus root essential oil, 0.1-0.3 part of agarwood essential oil, 0.5-5 parts of sweet orange essential oil, and 1-5 parts of chamomilla recutita flower essential oil. The present invention also provides a preparation method and uses of the composition. Through formula optimization and adjustment, the composition of the present invention removes components and bad odors that may cause adverse reactions, increases tolerance and scope of application; at the same time, by changing the dosage of agarwood, the curative effect can be guaranteed and the cost can be reduced, achieving the purpose of reducing costs and increasing efficiency; the formula is scientifically compatible, safe and effective, convenient to use, non-toxic and side-effect-free, and non-irritating.

Description

Technical Field

[0001] The present invention relates to a composition helpful for improving sleep function. Background Art

[0002] Insomnia is a common subjective sleep disorder. Research results show that with the accelerating pace of life and increasing pressure, the incidence rate has been rising year by year. More and more people have sleep problems, and it gradually shows a trend of being younger and more widespread. Long-term insomnia may cause memory loss, inattention, and decreased immunity, leading to adverse emotions such as anxiety and depression. In severe cases, it can induce hypertension, diabetes, coronary heart disease, dementia, and even sudden death, seriously affecting physical and mental health and quality of life. Currently, the clinical treatment methods for insomnia include drug treatment, acupuncture, massage, acupoint application, psychological intervention, etc., among which drug treatment is the main method. Western medicine commonly uses sedative, antidepressant, and anti-anxiety drugs for treatment. Although the effect is obvious in the short term, it is extremely prone to problems such as adverse reactions, drug dependence, and addiction. Traditional Chinese medicine aromatherapy has a long history and is an important part of external treatment methods in traditional Chinese medicine. Aromatic traditional Chinese medicines are helpful for regulating emotions and overcoming adverse emotions, and are of great significance for preventing and treating insomnia. Compared with Western medicine treatment, traditional Chinese medicine aromatherapy for treating insomnia has definite curative effects, is easy to use, has no dependence or addiction, and has no toxic and side effects. It can be used as an auxiliary method for treating insomnia or can be used alone.

[0003] The patent application with the publication number CN116196375A discloses a compound essential oil and its composition for preventing and / or treating insomnia. The compound essential oil contains the following components in parts by weight: 1 - 2 parts of frankincense essential oil, 0.5 - 1 part of costus root essential oil, 1 - 2 parts of lavender essential oil, 0.5 - 1 part of vetiver root essential oil, 0.25 - 0.5 part of chamomile essential oil, 0.5 - 1 part of agarwood essential oil, 1 - 2 parts of nardostachys jatamansi essential oil, 1 - 2 parts of geranium essential oil. This patent shows that agarwood essential oil, lavender essential oil, and the compound essential oil have good therapeutic effects on insomnia. Nardostachys jatamansi in the formula has a strong smell of stinky feet, and the smell is not good. Some users are intolerant to its smell. Although lavender essential oil and agarwood essential oil have good sleep-aiding effects, lavender essential oil contains chemical components that affect the endocrine system and may affect the normal development of children, so it is not suitable for children to use. Moreover, the planting area of agarwood is small, it is difficult to form agarwood, and the price is expensive. Agarwood essential oil is mainly extracted by distillation, and the yield is low. Only 1L of essential oil can be obtained from 150kg of agarwood, making agarwood essential oil even rarer and more precious. The dosage in the formula is large and the cost is high, which is not enough to meet the market demand. Therefore, it is of great significance to develop a product with a wide range of applicable people, high tolerance, low cost, safety, and effectiveness. Summary of the Invention

[0004] The present invention provides a new composition helpful for improving sleep function, and also provides a preparation method and use of the composition.

[0005] The present invention provides a composition that helps improve sleep function, which is prepared from raw materials in the following weight ratios:

[0006] 1 - 5 parts of cedar essential oil, 1 - 3 parts of frankincense essential oil, 0.5 - 2 parts of dalbergia odorifera essential oil, 0.5 - 2 parts of nutmeg essential oil, 0.3 - 1 part of costus root essential oil, 0.1 - 0.3 part of agarwood essential oil.

[0007] Furthermore, it is prepared from raw materials in the following weight ratios:

[0008] 1 - 5 parts of cedar essential oil, 1 - 3 parts of frankincense essential oil, 0.5 - 2 parts of dalbergia odorifera essential oil, 0.5 - 2 parts of nutmeg essential oil, 0.3 - 1 part of costus root essential oil, 0.1 - 0.3 part of agarwood essential oil.

[0009] Even more preferably, it is prepared from raw materials in the following weight ratios:

[0010] 2.0 parts of cedar essential oil, 1.5 parts of frankincense essential oil, 1.0 part of dalbergia odorifera essential oil, 1.0 part of nutmeg essential oil, 0.5 part of costus root essential oil, 0.2 part of agarwood essential oil.

[0011] Among them, the raw materials further contain sweet orange essential oil and chamomile essential oil, and their weight ratios are:

[0012] 0.5 - 5 parts of sweet orange essential oil, 1 - 5 parts of chamomile essential oil.

[0013] More preferably, it is prepared from raw materials in the following weight ratios:

[0014] 1.6 - 2.4 parts of cedar essential oil, 1.2 - 1.8 parts of frankincense essential oil, 0.8 - 1.2 parts of dalbergia odorifera essential oil, 0.8 - 1.2 parts of nutmeg essential oil, 0.4 - 0.6 part of costus root essential oil, 0.16 - 0.24 part of agarwood essential oil, 1.2 - 1.8 parts of sweet orange essential oil, 1.2 - 1.8 parts of chamomile essential oil.

[0015] Even more preferably, it is prepared from raw materials in the following weight ratios:

[0016] 2.0 parts of cedar essential oil, 1.5 parts of frankincense essential oil, 1.0 part of dalbergia odorifera essential oil, 1.0 part of nutmeg essential oil, 0.5 part of costus root essential oil, 0.2 part of agarwood essential oil, 1.5 parts of sweet orange essential oil, 1.5 parts of chamomile essential oil.

[0017] The composition of the present invention is prepared from raw materials in the following weight ratios: It is a preparation prepared by using the above raw materials as active ingredients and adding excipients or auxiliary components acceptable in pharmaceuticals or health products.

[0018] Among them, the preparation is an inhalation preparation or a topical preparation.

[0019] Further preferably, the inhalation preparation includes an aerosol, an inhaled powder, an atomized inhalation, an inhaled liquid preparation, a nasal spray, an aromatherapy agent; the topical preparation includes an aqueous solution, an emulsion, a cream, an ointment, an oil, a liniment.

[0020] The present invention also provides a method for preparing the composition helpful for improving sleep function, which comprises the following steps:

[0021] a. Weigh the raw materials in each weight ratio;

[0022] b. After mixing, add an excipient or an auxiliary component acceptable in pharmacy or health products to prepare a preparation.

[0023] The present invention also provides the use of the composition in preparing a health product or a cosmetic helpful for improving sleep function.

[0024] The present invention also provides the use of the composition in preparing a drug for preventing and / or treating insomnia.

[0025] The raw material frankincense essential oil in the composition of the present invention contains components such as octyl acetate and linalool. The natural linalool has a pure, sweet and elegant smell and has the effect of calming the nerves. Costus root essential oil contains components such as dehydrocostus lactone and costus lactone and has the effect of warming the middle-jiao and regulating the stomach, and is mainly used for treating syndromes such as qi stagnation in the spleen and stomach. Dalbergia odorifera essential oil has the highest nerolidol content and has the effects of calming the nerves, relieving depression and strengthening the spleen. Cedarwood essential oil has the effects of improving mood and soothing sleep. Agarwood essential oil contains terpenoids, eucalyptol, baillonal and chromone compounds, has a long-lasting fragrance and the fragrance enters the spleen, and has the effects of clearing the mind and regulating qi, warming the stomach and strengthening the spleen. Nutmeg essential oil contains compounds such as terpinene-4-ol, myristicin, elemicin, safrole, methyl eugenol, etc., is mild, spicy and fragrant, and has the effects of promoting qi flow and warming the middle-jiao, strengthening the spleen and promoting appetite, sedation and hypnosis, etc. Sweet orange essential oil has a soft smell and has the effects of sedation and soothing, etc. Roman chamomile essential oil, that is, chamomile essential oil, has a mild effect and can be used to soothe the mood.

[0026] In the raw material formulation of the composition of the present invention, frankincense is used as the monarch drug, which enters the liver, heart, and spleen meridians. The formulation adopts the idea of suppressing after promoting. Frankincense is used to activate blood circulation and promote qi movement. Then, cedar is used as the minister drug to balance the excessive warming and dredging property of frankincense, achieving the sleep effect of yang entering yin and yin-yang balance. "If the stomach is not in harmony, sleep will be disturbed." recorded in "Plain Questions · Theory of Counter-Regulation of Disorders". Aucklandia lappa is pungent, bitter, and warm; it enters the spleen, stomach, large intestine, triple energizer, and gallbladder meridians; it promotes qi movement to relieve pain, warms the middle-jiao and harmonizes the stomach. Dalbergia odorifera is pungent and warm; it enters the liver and spleen meridians; it promotes qi movement and activates blood circulation, relieves pain, and stops bleeding. Aquilaria sinensis is pungent, bitter, and slightly warm; it enters the spleen, stomach, and kidney meridians; it promotes qi movement to relieve pain, warms the middle-jiao to stop vomiting, and absorbs qi to relieve asthma. Amomum kravanh is pungent and warm; it enters the lung, spleen, and stomach meridians; it promotes qi movement to eliminate dampness, warms the middle-jiao to stop vomiting, and promotes appetite and digestion. Aucklandia lappa, Dalbergia odorifera, Aquilaria sinensis, and Amomum kravanh together serve as adjuvant drugs to achieve the effect of smooth and peaceful qi and blood, and jointly play a role in synergistic enhancement. Sweet orange and chamomile have soft and fragrant odors, guiding each drug into the zang-fu organs and qi and blood, helping yang enter yin, so as to make yin and yang peaceful. The compatibility of various drugs follows the treatment principle of "aromatic qi-promoting" in traditional Chinese medicine aromatherapy, with qi and blood harmonized, blood returning to the liver, and jointly achieving the effect of tranquilizing sleep.

[0027] Through formula adjustment, removing the components and bad odors that may cause adverse reactions, and at the same time changing the dosage of Aquilaria sinensis, it can not only ensure the curative effect but also reduce the cost, achieving the purpose of cost reduction and efficiency improvement; the formula is scientifically compatible, safe and effective, convenient to use, non-toxic and side effects, and non-irritating. Detailed implementation method

[0028] Use common extraction methods for aromatic essential oils such as supercritical CO2 extraction method, steam distillation method, and pressing method to extract single essential oils.

[0029] Use the steam distillation method to extract frankincense, Aucklandia lappa, Dalbergia odorifera, cedar, chamomile, Aquilaria sinensis, and nutmeg essential oils. Place the raw materials in a volatile oil extraction tank, perform steam distillation for 2 - 4 hours, let it stand, and after the oil and water are completely separated, separate the essential oil.

[0030] Use the cold pressing method to extract sweet orange essential oil. Place sweet orange in a pressing machine for pressing, and separate the sweet orange essential oil.

[0031] The raw materials in the composition of the present invention can be extracted by the above methods or purchased commercially.

[0032] The beneficial effects of the present invention are demonstrated by the following specific efficacy tests.

[0033] Test Example 1 Coarse screening test on the compatibility prescription and ratio of the raw materials of the present invention

[0034] Composition 1: 2.0 g of cedar essential oil, 1.5 g of frankincense essential oil, 1.0 g of Dalbergia odorifera essential oil, 1.0 g of nutmeg essential oil, 0.5 g of Aucklandia lappa essential oil;

[0035] Composition 2: 2.0 g of cedar essential oil, 1.5 g of frankincense essential oil, 1.0 g of dalbergia odorifera essential oil, 1.0 g of nutmeg essential oil, 0.5 g of costus root essential oil, 0.2 g of agarwood essential oil;

[0036] Composition 3: 2.0 g of cedar essential oil, 1.5 g of frankincense essential oil, 1.0 g of dalbergia odorifera essential oil, 1.0 g of nutmeg essential oil, 0.5 g of costus root essential oil, 0.2 g of agarwood essential oil, 1.5 g of sweet orange essential oil, 1.5 g of chamomile essential oil;

[0037] Composition 4: 1.0 g of cedar essential oil, 1.5 g of frankincense essential oil, 0.5 g of dalbergia odorifera essential oil, 1.0 g of nutmeg essential oil, 0.5 g of costus root essential oil, 0.1 g of agarwood essential oil, 0.5 g of sweet orange essential oil, 1.0 g of chamomile essential oil;

[0038] Composition 5: 4.0 g of cedar essential oil, 3.0 g of frankincense essential oil, 2.0 g of dalbergia odorifera essential oil, 2.0 g of nutmeg essential oil, 1.0 g of costus root essential oil, 0.3 g of agarwood essential oil, 5.0 g of sweet orange essential oil, 5.0 g of chamomile essential oil;

[0039] When the components in the composition are formulated, the selection of their dosages needs to comprehensively consider factors such as the efficacy, properties, aroma, safety, and irritation after the formulation of each component.

[0040] Preliminary pre - test of the pharmacodynamic experiment shows that Compositions 1 - 5 all have a sleep - promoting effect, and the effects of Compositions 2 - 5 are better than that of Composition 1;

[0041] The top note of Composition 2 is faint, and the base note has a strong woody fragrance. The fragrance is light at first and heavy later, with relatively poor softness.

[0042] Compositions 3 - 5 use sweet orange essential oil and chamomile essential oil to blend the top note.

[0043] Comparing Compositions 3 - 5, Composition 3 has the best sleep - promoting effect, fragrance, safety, etc.; Composition 4 reduces the dosages of cedar essential oil and agarwood essential oil, and its sleep - promoting effect is slightly worse; Composition 5 reduces the proportion of agarwood essential oil and increases the proportions of sweet orange essential oil and chamomile essential oil, and the top - note smell is too strong, with the fragrance being heavy at first and light later.

[0044] Test Example 2 Animal tests of the drugs of the present invention

[0045] 1 Comparative study on efficacy

[0046] A rat insomnia model was induced by p - chlorophenylalanine (PCPA). The sleep latency and sleep duration before and after treatment were compared through the pentobarbital sodium sleep experiment. The contents of 5 - hydroxytryptamine (5 - HT) in the hypothalamus and hippocampus and dopamine (DA) in the hypothalamus and striatum of rats in each group were detected by enzyme - linked immunosorbent assay (ELISA).

[0047] 1.1 Test drugs

[0048] Compound essential oil 1: The compound essential oil of composition 1.

[0049] Compound essential oil 2: The compound essential oil of composition 2.

[0050] Compound essential oil 3: The compound essential oil of composition 3.

[0051] 1.2 Grouping and model establishment

[0052] Forty-eight male SD rats, weighing 200 ± 20 g, were randomly divided into 6 groups, namely the normal control group, the model control group, the positive control group, the compound essential oil 1 group, the compound essential oil 2 group, and the compound essential oil 3 group, with 8 rats in each group. After one week of adaptive feeding, a insomnia model was induced by p-chlorophenylalanine (PCPA). Except for the normal control group, the rats in the other groups were intraperitoneally injected with PCPA at 9:00 - 10:00 am on the 8th and 9th days to replicate the model, with an injection dose of 300 mg / kg. The normal control group was intraperitoneally injected with the same volume of normal saline. 30 hours after the first intraperitoneal injection, the rats were observed for hyperactivity, increased activity, dull and lusterless hair, and disappearance of the circadian rhythm, indicating successful model replication.

[0053] 1.3 Treatment methods

[0054] The rats in the blank control group were normally fed daily without any treatment. After the rats in the model control group, the positive control group, and the experimental groups were modeled, they were placed in a self-made breeding box. The breeding box should be relatively airtight and not affect the rats' breathing. The diffuser was fixed in the breeding box. According to the above grouping method, 10 mg of compound essential oil was dropped into the diffuser in the experimental groups, and diffused for 15 minutes. 2 drops of distilled water were dropped in the model group. The positive group was intragastrically administered with a 1.5 mg / kg concentration of diazepam solution for 7 consecutive days.

[0055] 1.4 Behavioral evaluation

[0056] One hour after the end of the drug administration on the 7th day, a pentobarbital sodium sleep experiment was conducted. The pentobarbital sodium solution was intraperitoneally injected at a dose of 35 mg / kg, and the differences in sleep latency and sleep time among groups were recorded according to the disappearance of the righting reflex for more than 30 s.

[0057] 1.5 Specimen collection

[0058] After the pentobarbital sodium sleep experiment was over, the rats in each group were decapitated on an ice table to remove the brain, and the hypothalamus and hippocampal tissues were taken. The contents of 5-HT in the hypothalamus and hippocampus, and the contents of DA in the hypothalamus and striatum were measured by ELISA method.

[0059] 2. Results and conclusions of the efficacy comparison research experiment

[0060] 2.1 Results of behavioral evaluation

[0061] Compared with the blank control group, the sleep latency of rats in the model control group increased significantly, and the sleep duration decreased significantly. The difference was statistically significant (P < 0.01), indicating that the model was successfully established. Compared with the model control group, the sleep latency decreased (P < 0.01) and the sleep duration increased (P < 0.01) in the compound essential oil 1 group, compound essential oil 2 group, compound essential oil 3 group, and positive control group. Compared with the positive control group, the sleep latency increased and the sleep duration decreased (P < 0.05) in the compound essential oil 1 group, compound essential oil 2 group, and compound essential oil 3 group, indicating that the efficacy of compound essential oil 1, compound essential oil 2, and compound essential oil 3 was lower than that of diazepam at this dose, but all could improve the sleep status of insomnia rats, and the effect of compound essential oil 2 was better than that of compound essential oil 1. The results are shown in Table 1:

[0062] Table 1 Effects on sleep latency and sleep time of rats( n = 8)

[0063]

[0064]

[0065] (Note: Compared with the model control group, * P < 0.05, ** P < 0.01; compared with the blank control group, # P < 0.05, ## P < 0.01; compared with the positive control group: ▲ P < 0.05, ▲▲ P < 0.01)

[0066] 2.2 Effects on the contents of 5-HT and DA in insomnia rats

[0067] Compared with the blank control group, the content of 5-HT in the hypothalamus and hippocampus of rats in the model control group decreased significantly, and the content of DA in the hypothalamus and striatum increased significantly. The difference was statistically significant (P < 0.01). Compared with the model control group, the content of 5-HT in the hypothalamus and hippocampus of rats in the experimental group and positive control group increased (P < 0.05), and the content of DA in the hypothalamus and striatum decreased (P < 0.05). Compared with the positive control group, compound essential oil 1, compound essential oil 2, and compound essential oil 3 all had the effect of improving or treating rat insomnia, and the drug effects of compound essential oil 2 and compound essential oil 3 were better than that of compound essential oil 1. The results are shown in Table 2:

[0068] Table 2 Contents of 5-HT and DA in rats (ng / g)( n = 8)

[0069]

[0070] (Note: Compared with the model control group, * P < 0.05, ** P < 0.01; compared with the blank control group, # P < 0.05, ## P < 0.01; compared with the positive control group: ▲ P < 0.05, ▲▲ P < 0.01)

[0071] According to the above experimental results: Compound essential oil 1, compound essential oil 2 and compound essential oil 3 can all significantly shorten the sleep latency of insomnia rats, prolong the sleep duration, regulate the levels of 5-HT and DA in the body of insomnia rats, and effectively improve insomnia symptoms; Composition 2 adds agarwood essential oil on the basis of Composition 1. The experimental results confirm that the curative effect of compound essential oil 2 is significantly better than that of compound essential oil 1, indicating that the addition of agarwood essential oil has a synergistic effect; Composition 3 adds sweet orange essential oil and chamomile essential oil on the basis of Composition 2 to adjust the aroma, which can not only ensure the curative effect, but also improve the aroma and enrich the odor level.

[0072] Test Example 3 Clinical trial of the composition of the present invention

[0073] 1. Comparison of clinical use of different formula compositions

[0074] Comparative Composition 1: The compound essential oil in Example 3 of Patent CN116196375A: 1 g of frankincense essential oil, 1 g of costus root essential oil, 1 g of agarwood essential oil, 1 g of lavender essential oil, 0.5 g of vetiver root essential oil, 1 g of nardostachys jatamansi essential oil, 1 g of geranium essential oil, 0.5 g of chamomile essential oil.

[0075] Composition 3: The compound essential oil in the preferred proportion of Formula 3.

[0076] There are obvious differences in the properties and fragrances between Comparative Composition 1 and Composition 3. Comparative Composition 1 is a yellowish-brown transparent oily liquid, and Composition 3 is a reddish-brown transparent oily liquid. After diffusion by the diffusion method, Comparative Composition 1 has a slightly foot odor in the top note.

[0077] Prepare creams with Comparative Composition 1 and Composition 3, using stearic acid, vaseline, glycerol, triethanolamine, and distilled water as the matrix. Heat glycerol, triethanolamine, and distilled water to 80°C, slowly add the heated and dissolved stearic acid and vaseline, continuously stir to mix the two phases evenly, add an appropriate amount of the composition, stir evenly, and let it cool to prepare the cream. (Each 100 g of the finished product contains 2 g of the compound essential oil.)

[0078] Both are creamy pastes, with a soft, mild texture and easy to spread, and there are no obvious differences in the two properties.

[0079] 1.1 Case source

[0080] Select 240 insomnia patients admitted to a certain tertiary hospital in Chengdu from October 2022 to October 2023, and randomly divide them into 4 groups, with 60 patients in each group. Among them, 2 groups are given aromatherapy with combination 1 and composition 3, and the remaining two groups use facial cream for facial administration. There is no significant difference in the gender, age, course of disease and condition of the patients in each group (P>0.05), and they are comparable.

[0081] 1.2 Diagnostic criteria

[0082] Refer to the "Diagnostic Criteria for Adult Insomnia" formulated in the latest domestic version of the "Diagnosis and Treatment Guidelines for Adult Insomnia in China" in 2017.

[0083] 1.3 Inclusion criteria

[0084] (1) Meet the diagnostic criteria for insomnia and be in the attack period;

[0085] (2) Aged 18 to 70 years old;

[0086] (3) Be able to correctly describe their own wishes, voluntarily fill in the informed consent form, and agree to participate in clinical trials;

[0087] (4) Have not participated in other clinical studies;

[0088] Those who meet all of the above 4 criteria can be included.

[0089] 1.4 Exclusion criteria

[0090] (1) Do not meet the diagnostic criteria for insomnia;

[0091] (2) Pregnant or lactating women or women preparing for pregnancy;

[0092] (3) Patients with malignant tumors or mental illnesses;

[0093] (4) Patients with poor compliance;

[0094] (5) Those who are unwilling to sign the informed consent form;

[0095] (6) Those who have received other relevant treatments that may affect the observation of the effect indicators of this study.

[0096] 1.5 Exclusion criteria

[0097] (1) During the trial, it is found that the subject meets the exclusion criteria or does not meet the inclusion criteria;

[0098] (2) During the trial, the subject self-administers other treatments that may affect the experimental results;

[0099] (3) Various patients who cannot cooperate with the treatment.

[0100] 1.6 Treatment methods

[0101] For the aromatherapy group, contrast combination 1 and composition 3 were used for atomizing aromatherapy before going to bed every night. 2 - 3 drops (about 0.04 - 0.06 g essential oil) were added each time, and atomizing aromatherapy was carried out for 20 min. Continuous use for 7 days was regarded as one course of treatment.

[0102] For the cream group, contrast combination 1 cream and composition 3 cream were used for smearing before going to bed every night. After facial cleansing, they were evenly smeared on the face, once a day, 0.5 g (0.01 g essential oil) each time. Continuous use for 7 days was regarded as one course of treatment.

[0103] 1.7 Evaluation method

[0104] A single - blind experiment was adopted. Before and after drug administration, the Pittsburgh Sleep Quality Index (PSQI) sleep evaluation method, which is internationally common, was used for sleep evaluation (see Appendix 1 and Appendix 2). PSQI is usually used to evaluate the sleep quality in the recent 1 month. It consists of 19 self - rating items and 5 other - rating items. Among them, the 19th self - rating item and 5 other - rating items do not participate in scoring. The 18 self - rating items for scoring form 7 components. Each component is scored on a scale of 0 - 3 points. "0" points mean no difficulty, and "3" points mean very difficult. The scores of each component are added up to get the total PSQI score. The total score ranges from 0 to 21. The higher the score, the worse the sleep quality. "0" points mean no difficulty, and "21" points mean very difficult in all aspects.

[0105] According to the PSQI score, the curative effect was judged as follows: cured: curative effect index ≥ 75%; markedly effective: 50% ≤ curative effect index < 75%; effective: 25% ≤ curative effect index < 50%; ineffective: curative effect index < 25%.

[0106] Curative effect index = (pre - treatment score - post - treatment score) / pre - treatment score × 100%.

[0107] 2. Clinical trial results and discussion

[0108] The clinical trial volunteers were medicated for 30 days, and the PSQI sleep quality evaluation was carried out. The evaluation results before and after medication were compared. The results are shown in Table 3.

[0109] Table 3 Analysis table of insomnia treatment effect

[0110]

[0111] According to the above experimental results, the two compositions in this study both have good therapeutic effects on insomnia, and there is no significant difference in the aromatherapy administration effect; after being made into creams and smeared on the skin, the administration dose of the compositions is significantly reduced, and the effect of composition 3 is better than that of contrast composition 1.

[0112] The present invention provides an essential oil composition for improving or treating sleep disorders. After the formulation is adjusted, it can reduce costs, reduce toxicity, enhance efficacy, and remove unpleasant odors. Its compatibility is scientific, and each component synergistically plays a role in sedation and relaxation, improving or treating sleep disorders.

[0113] Appendix 1:

[0114] Pittsburgh Sleep Quality Index (PSQI)

[0115] The following questions are about your sleep situation in the recent 1 month. Please choose and fill in the answers that best match your actual situation in the recent 1 month. Please answer the following questions:

[0116]

[0117] Sleep quality score (), Sleep latency score (), Sleep duration score (), Sleep efficiency score ()

[0118] Sleep disorder score (), Hypnotic medication score (), Daytime dysfunction score (), PSQI total score ()

[0119] Examiner:

[0120] Appendix 2:

[0121] Usage and statistical methods of the Pittsburgh Sleep Quality Index

[0122] PSQI is used to evaluate the sleep quality in the recent 1 month. It consists of 19 self-assessment and 5 other-assessment items. Among them, the 19th self-assessment item and 5 other-assessment items do not participate in scoring. The 18 self-assessment items that are scored form 7 components, and each component is scored on a scale of 0 - 3 points. "0" points means no difficulty, and "3" points means very difficult. The scores of each component are added up to the PSQI total score. The total score range is 0 - 21. The higher the score, the worse the sleep quality. "0" points means no difficulty, and "21" points means very difficult in all aspects.

[0123]

[0124] * Sleep efficiency calculation method:

[0125]

[0126] PSQI calculation method:

[0127] PSQI total score = Component A score + Component B score + Component C score + Component D score + Component E score + Component F score + Component G score.

Claims

1. A composition that helps improve sleep function, characterized in that: It is prepared from the following raw materials in the following weight ratios: Cedar essential oil 1.6 - 2.4 parts, frankincense essential oil 1.2 - 1.8 parts, dalbergia odorifera essential oil 0.8 - 1.2 parts, myristica fragrans essential oil 0.8 - 1.2 parts, costus root essential oil 0.4 - 0.6 parts, agarwood essential oil 1.16 - 0.24 parts, sweet orange essential oil 1.2 - 1.8 parts, chamomilla recutita flower essential oil 1.2 - 1.8 parts.

2. The composition according to claim 1, which is helpful for improving sleep function, is characterized in that: It is prepared from the following raw materials in the following weight ratios: Cedar essential oil 2.0 parts, frankincense essential oil 1.5 parts, dalbergia odorifera essential oil 1.0 parts, myristica fragrans essential oil 1.0 parts, costus root essential oil 0.5 parts, agarwood essential oil 0.2 parts, sweet orange essential oil 1.5 parts, chamomilla recutita flower essential oil 1.5 parts.

3. The composition according to claim 1 or 2, which is helpful for improving sleep function, is characterized in that: It is a preparation prepared from the said raw materials as active ingredients and adding pharmaceutically acceptable excipients or auxiliary ingredients.

4. The composition according to claim 3, which is helpful for improving sleep function, characterized in that: The said preparation is an inhalation preparation or a topical preparation.

5. A method for preparing a composition according to any one of claims 1-4 that helps improve sleep function, characterized in that: It comprises the following steps: a. Weigh the raw materials in the respective weight ratios; b. After mixing, add pharmaceutically acceptable excipients or auxiliary ingredients to prepare the preparation.

6. Use of the composition according to any one of claims 1 - 4 in the preparation of a medicament for preventing and / or treating insomnia.

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