A traditional Chinese medicine composition with the function of calming the nerves, its preparation method and uses

Abstract

The present invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with a sedative effect, a preparation method thereof, and uses thereof. The traditional Chinese medicine composition with a sedative effect of the present invention is prepared from the following raw materials: sandalwood essential oil, lavender essential oil, tea tree oil from Australia, rose essential oil, zizyphus jujuba seed essential oil, peppermint essential oil, astragalus membranaceus essential oil, coptis chinensis essential oil, cinnamon essential oil, and base oil. The traditional Chinese medicine composition of the present invention utilizes the traditional Chinese medicine compatibility theory, enabling the various essential oils in the formula to be compatibly combined with each other to exert a synergistic effect. The experimental results show that the traditional Chinese medicine composition of the present invention has the effects of soothing nerves, relaxing emotions, and improving sleep quality. The curative effect of the traditional Chinese medicine composition of the present invention is stable and the price is low. In addition, clinically, it is found that it also has a good auxiliary effect on astringing catarrhal secretions.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with a soothing effect, a preparation method thereof, and uses thereof. Background Art

[0002] Insomnia refers to a continuous condition where the quality or quantity of sleep is unsatisfactory, caused by excessive thinking, nervousness, terror, overwork, change of circumstances, or neuropathological damage, etc. Clinical manifestations include difficulty in falling asleep, light sleep, easy awakening, early awakening, frequent dreams, fatigue after waking up, or lack of a sense of wakefulness, drowsiness during the day, etc. Insomnia is the most common nocturnal sleep disorder, and as a primary or secondary state, it is both a symptom and a disease. Insomnia can lead to daytime functional deficiencies and a significant reduction in the quality of life. Long-term insomnia often leads to a decline in the body's immunity and memory, and generates adverse emotions such as fear and anxiety. At the same time, it is also prone to induce hypertension, neurasthenia, and even cause sudden death. With the rapid development of the economic society and the continuous acceleration of the pace of life, the incidence of insomnia is increasing continuously, and the treatment of insomnia has received more and more attention. The goal of treating insomnia is to help patients restore good sleep quality and improve their physical and mental health to the greatest extent.

[0003] Commonly used Western medical treatment methods include drug treatment, behavioral therapy, and psychotherapy, etc. Western medical drugs for treating insomnia mainly include the first-generation barbiturates, the second-generation benzodiazepines, and the third-generation non-benzodiazepines. Among them, benzodiazepine drugs are the most widely used hypnotics in clinical practice at present. However, the treatment of insomnia with Western medicine has great limitations. It only treats the symptoms but not the root cause. Long-term use is likely to cause adverse reactions such as psychomotor impairment, memory impairment, drug addiction, and recurrence of the disease after drug withdrawal. The side effects are large, and the clinical application is limited.

[0004] As one of the traditional treatment methods, traditional Chinese medicine has unique advantages in the clinical application of treating insomnia with the characteristics of overall conditioning, syndrome differentiation and treatment, treating both the symptoms and the root cause, good curative effect, and few adverse reactions. However, traditional Chinese medicine usually takes effect slowly and requires a certain treatment course. In addition, traditional Chinese medicine decoctions have a strong taste and large dosage, and may also cause irritation to the gastrointestinal tract, and are inconvenient to carry, resulting in poor medication compliance of patients, making it difficult for patients to adhere to long-term use. Therefore, the commonly used traditional Chinese medicines for preventing and treating insomnia in clinical practice still cannot meet the needs of patients.

[0005] In view of this, the present invention is proposed. Summary of the Invention

[0006] In order to overcome the defects and deficiencies existing in the prior art, the present invention utilizes the compatibility theory of traditional Chinese medicine and provides a traditional Chinese medicine composition with a sedative effect, its preparation method and uses. The various essential oils in the formula of the present invention are formulated with each other to play a synergistic effect, making the traditional Chinese medicine composition of the present invention have a significant and stable curative effect in preventing and treating insomnia, and no toxic and side effects.

[0007] To achieve the purpose of this invention, the present invention adopts the following technical solutions:

[0008] In the first aspect, the present invention provides a traditional Chinese medicine composition with a sedative effect, which is prepared from the following raw materials in parts by weight: 1-5 parts of sandalwood essential oil, 1-5 parts of lavender essential oil, 1-5 parts of Australian tea tree essential oil, 1-5 parts of rose essential oil, 1-5 parts of ziziphus jujuba seed essential oil, 0.1-3 parts of peppermint essential oil, 0.1-3 parts of astragalus essential oil, 1-5 parts of coptis essential oil, 1-5 parts of cinnamon essential oil, and 200 parts of base oil.

[0009] As an optional way, in the above traditional Chinese medicine composition, it is prepared from the following raw materials in parts by weight: 1.5-2.5 parts of sandalwood essential oil, 1.5-2.5 parts of lavender essential oil, 1.5-2.5 parts of Australian tea tree essential oil, 1.5-2.5 parts of rose essential oil, 1.5-2.5 parts of ziziphus jujuba seed essential oil, 0.5-1.5 parts of peppermint essential oil, 0.5-1.5 parts of astragalus essential oil, 1.5-2.5 parts of coptis essential oil, 1.5-2.5 parts of cinnamon essential oil, and 200 parts of base oil.

[0010] As an optional way, in the above traditional Chinese medicine composition, it is prepared from the following raw materials in parts by weight: 2 parts of sandalwood essential oil, 2 parts of lavender essential oil, 2 parts of Australian tea tree essential oil, 2 parts of rose essential oil, 2 parts of ziziphus jujuba seed essential oil, 1 part of peppermint essential oil, 1 part of astragalus essential oil, 2 parts of coptis essential oil, 2 parts of cinnamon essential oil, and 200 parts of base oil.

[0011] As an optional way, in the above traditional Chinese medicine composition, the base oil is selected from one or more of the following: grape seed oil, sweet almond oil, jojoba oil or wheat germ oil.

[0012] In the second aspect, the present invention provides a preparation method of the traditional Chinese medicine composition described in the first aspect above. The preparation method includes the following steps: adding various essential oils into the base oil according to the parts by weight and fully mixing and stirring to obtain.

[0013] In the third aspect, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect above or the traditional Chinese medicine composition prepared by using the preparation method described in the second aspect above in the preparation of a drug for preventing or treating insomnia.

[0014] As an alternative, in the above uses, the insomnia is chronic insomnia, intractable insomnia, primary insomnia, menopausal insomnia or senile insomnia.

[0015] As an alternative, in the above uses, the drug is an external preparation.

[0016] As an alternative, in the above uses, the external preparation is a nasal drop, a gel, an ointment, a patch, a liniment, a tincture, a lotion or a film-forming agent.

[0017] As an alternative, in the above uses, the external preparation is an essential oil patch.

[0018] More preferably, the external preparation is an essential oil acupoint patch. For example, the administration acupoint can be the Sanyinjiao acupoint.

[0019] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0020] The present invention utilizes the theory of compatibility of traditional Chinese medicine and provides a traditional Chinese medicine composition with a sedative effect, its preparation method and uses. The various essential oils in the formula of the present invention are compatible with each other to exert a synergistic effect, so that the traditional Chinese medicine composition of the present invention has remarkable curative effect, stable effect in preventing or treating insomnia, and no toxic and side effects.

[0021] Experimental results show that the traditional Chinese medicine composition of the present invention has the effects of soothing nerves, relaxing emotions and improving sleep quality. The traditional Chinese medicine composition of the present invention has stable curative effect and low price. In addition, it is clinically found that it also has a good auxiliary effect on astringing catarrhal secretions.

[0022] The traditional Chinese medicine composition of the present invention uses essential oil as a raw material, has a simple preparation method, few preparation processes and high production efficiency.

[0023] The traditional Chinese medicine composition of the present invention has a simple usage method. Patients can play the roles of soothing nerves, relaxing emotions and improving sleep quality through nasal application or essential oil acupoint patch administration methods, can significantly improve the quality of life of patients, and has good application prospects. Description of the Drawings

[0024] The drawings are used to provide further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation to the present invention. In the drawings:

[0025] Figure 1 : Schematic diagram of the use of the essential oil acupoint patch of the traditional Chinese medicine composition of the present invention.

[0026] Figure 2 : Physical photo of the essential oil acupoint patch of the traditional Chinese medicine composition of the present invention. Detailed Embodiments

[0027] Among the various essential oil raw materials used in the traditional Chinese medicine composition of the present invention, sandalwood essential oil has the effects of sedation and relaxation; lavender essential oil can relieve stress and promote sleep; tea tree oil from Australia can reduce anxiety and tension; rose essential oil helps to soothe the mood and relieve tension; jujube seed essential oil can soothe the nervous system and promote sleep; peppermint essential oil has a refreshing and cooling effect; astragalus essential oil can enhance physical strength and improve immunity; coptis and cinnamon essential oils are based on the traditional Chinese medicine theory of the intersection of the heart and kidney, clearing heart fire, warming kidney water, and promoting sleep. Grape seed oil, as a base oil, has the functions of moisturizing, lubricating, and diluting essential oils.

[0028] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the scope of the present invention.

[0029] For those where specific techniques or conditions are not indicated in the embodiments, they shall be in accordance with the techniques or conditions described in the literature in this field or in accordance with the product instructions. For reagents or instruments whose manufacturers are not indicated, they are all conventional products that can be obtained through regular channels.

[0030] The experimental methods in the following examples are all conventional methods unless otherwise specified. The test materials used in the following examples are all commercially available products unless otherwise specified. Preparation example:

[0031] Example 1:

[0032] A traditional Chinese medicine composition with a calming effect is prepared from the following raw materials in parts by weight: 2 parts of sandalwood essential oil, 2 parts of lavender essential oil, 2 parts of tea tree oil from Australia, 2 parts of rose essential oil, 2 parts of jujube seed essential oil, 1 part of peppermint essential oil, 1 part of astragalus essential oil, 2 parts of coptis essential oil, 2 parts of cinnamon essential oil, and 200 parts of grape seed oil.

[0033] The preparation method of the traditional Chinese medicine composition includes the following steps: adding various essential oils to grape seed oil according to the parts by weight and mixing and stirring thoroughly to obtain.

[0034] Example 2:

[0035] A traditional Chinese medicine composition with a calming effect is prepared from the following raw materials in parts by weight: 2.5 parts of sandalwood essential oil, 1.5 parts of lavender essential oil, 1.5 parts of tea tree oil from Australia, 2.5 parts of rose essential oil, 2 parts of jujube seed essential oil, 1 part of peppermint essential oil, 1 part of astragalus essential oil, 2 parts of coptis essential oil, 2 parts of cinnamon essential oil, and 200 parts of grape seed oil.

[0036] The preparation method of the traditional Chinese medicine composition includes the following steps: adding various essential oils to grape seed oil according to the parts by weight and mixing and stirring thoroughly to obtain.

[0037] Comparative Example 1:

[0038] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 4 parts of sandalwood essential oil, 2 parts of tea tree oil from Australia, 2 parts of rose essential oil, 2 parts of ziziphus jujuba seed essential oil, 1 part of peppermint essential oil, 1 part of astragalus essential oil, 2 parts of coptis chinensis essential oil, 2 parts of cinnamon essential oil, and 200 parts of grape seed oil.

[0039] The preparation method of the traditional Chinese medicine composition comprises the following steps: adding various essential oils into grape seed oil according to the parts by weight, and fully mixing and stirring to obtain the composition.

[0040] Comparative Example 2:

[0041] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2 parts of sandalwood essential oil, 2 parts of lavender essential oil, 2 parts of tea tree oil from Australia, 2 parts of rose essential oil, 2 parts of poria cocos essential oil, 1 part of peppermint essential oil, 1 part of astragalus essential oil, 2 parts of coptis chinensis essential oil, 2 parts of cinnamon essential oil, and 200 parts of grape seed oil.

[0042] The preparation method of the traditional Chinese medicine composition comprises the following steps: adding various essential oils into grape seed oil according to the parts by weight, and fully mixing and stirring to obtain the composition.

[0043] Effect Example:

[0044] Effect Example 1: The effect of the traditional Chinese medicine composition of the present invention on improving insomnia

[0045] 1. Experimental animals:

[0046] Healthy male SD rats of SPF grade, with body weight of 200 - 220 g.

[0047] 2. Main experimental drugs:

[0048] The traditional Chinese medicine compositions used in the effect examples are all prepared by the above-mentioned preparation examples. Esazolam tablets are purchased from Huazhong Pharmaceutical Co., Ltd.

[0049] 3. Experimental methods:

[0050] 3.1 Grouping of experimental animals and drug administration:

[0051] 70 SD rats are divided into 7 groups according to the random number table method, with 10 rats in each group. They are randomly divided into a normal control group, a model group, an esazolam group, an Example 1 group, an Example 2 group, a Comparative Example 1 group, and a Comparative Example 2 group. The Example 1 group, the Example 2 group, the Comparative Example 1 group, and the Comparative Example 2 group are all administered 20 μL by nasal drip once a day. The normal control group and the model group are given grape seed oil with the same scheme. After the rats are successfully modeled, they are continuously administered for 7 days. The esazolam group is administered by gavage for 7 days. The dosage of esazolam tablets for rats is calculated according to the body surface area formula for adult drug dosage, and the dosage for rats is 0.18 mg / kg.

[0052] 3.2 Model establishment and identification:

[0053] 3.2.1 Establishment of insomnia rat model:

[0054] An insomnia model was prepared by intraperitoneal injection of p-chlorophenylalanine (PCPA): PCPA suspension was intraperitoneally injected from 8:00 to 9:00 in the morning, once a day for 2 consecutive days. PCPA is an inhibitor of tryptophan hydroxylase (TDH). By blocking 5-HT synthesis, it causes a decrease in the content of 5-HT in the rat brain, thereby eliminating the circadian rhythm.

[0055] 3.2.2 Model identification:

[0056] If the circadian rhythm of the rats is disordered, they are active during the day, more sensitive to external stimuli such as sound and light, with increased excitability and aggression, and at the same time, their diet and defecation and urination increase, and the feces color is grayish white, showing obvious differences compared with the blank group, it proves that the model establishment is successful.

[0057] 3.3 Threshold dose of pentobarbital sodium and cooperative hypnosis time:

[0058] In the experiment, the disappearance of the righting reflex of the animals for 1 min was used as the sleep onset index, and the flipping 3 times within 30 s was used as the sleep end index. The time from the disappearance of the righting reflex to the recovery of each rat was recorded as the sleep time. After model establishment and after the treatment intervention, a cooperative hypnosis test was carried out with the determined threshold dose of pentobarbital sodium (in previous studies, the threshold dose of pentobarbital sodium was determined to be 40 mg / kg according to the minimum dose at which all rats fell asleep within 15 min after intraperitoneal injection of pentobarbital sodium). Parameters such as sleep latency and sleep time were used to judge the replication of the model and the effect of the treatment intervention on the cooperative sleep of rats with the threshold dose of pentobarbital sodium, so as to judge whether the treatment intervention has an effect of inducing sleep.

[0059] 3.4 Macroscopic sign evaluation:

[0060] The mental state, fur color, sleep, diet, drinking water and other behavioral changes of the rats were dynamically observed before and after model establishment. And the body weights of the 7 groups of rats were weighed before and after model establishment and after the intervention ended, and recorded.

[0061] 3.5 Statistical analysis method:

[0062] SPSS 22.0 statistical software was used, and all experiments were repeated 3 times. Measurement data were expressed as One-way ANOVA was used for comparison among multiple groups, and LSD-t test was used for pairwise comparison. p < 0.05 was considered statistically significant.

[0063] 4. Experimental results:

[0064] 4.1 Effects of the traditional Chinese medicine composition of the present invention on the hypnotic effect of rats induced by supra-threshold dose of pentobarbital sodium:

[0065] The experimental results are shown in Table 1. The results indicate that, compared with the normal control group, the sleep latency of the rats in the model group was significantly prolonged (p < 0.01), while the sleep time was less (p < 0.01). Compared with the model group, the sleep latency of the rats in the Example 1 group, the Example 2 group and the estazolam group was significantly shortened (p < 0.01), and the shortening of the sleep latency of the rats in the Example 1 group was slightly better than that of the positive control drug estazolam group. For the Comparative Example 1-2 groups, they were significantly inferior to the Example 1 group, the Example 2 group and the positive control group in both sleep latency and sleep time. These results show that the types of each medicinal flavor in the traditional Chinese medicine composition of the present invention are all very closely related to its effect in treating insomnia. Therefore, subtracting and replacing some medicinal flavors may reduce the efficacy of the traditional Chinese medicine composition of the present invention.

[0066] Table 1: Effects of the traditional Chinese medicine composition of the present invention on the hypnotic effect of rats induced by supra-threshold dose of pentobarbital sodium

[0067]

[0068] Note: Compared with the normal control group, ## p < 0.01; compared with the model group, * p < 0.05, ** p < 0.01. 4.2 Effects of the traditional Chinese medicine composition of the present invention on the macroscopic signs of rats

[0069] The rats in the control group had good mental state, sensitive response, shiny hair color, normal diet, drinking water and body weight. The sleep rhythm was obvious, showing active at night and resting during the day. Compared with the control group, the rats in the model group began to show poor mental state, dull hair color, shrill calls within 1 week after injecting PCPA, and sometimes were manic, irritable, aggressive, with increased standing confrontation and biting times, disappearance of the circadian rhythm, reduced food intake, and significantly decreased body weight (p < 0.01, specific data not listed). Compared with the model group, the confrontation and biting times of the rats in the Example 1 group, the Example 2 group and the positive control drug estazolam group decreased, the cleaning behavior was basically flexible, the calls were soft, the hair was shiny, the food intake increased, the circadian rhythm was basically restored, and the body weight continued to increase (p < 0.01, specific data not listed). The above results show that the traditional Chinese medicine composition of the present invention can effectively regulate the mental state and behavioral performance of insomnia rats and increase their body weight. For each comparative example group, their body weight indexes were significantly inferior to those of the Example 1-2 groups after treatment. These results show that the types of each medicinal flavor in the traditional Chinese medicine composition of the present invention are all very closely related to its effect in treating insomnia. Therefore, subtracting and replacing some medicinal flavors may reduce the efficacy of the traditional Chinese medicine composition of the present invention.

[0070] Effect Example 2: Comparative clinical experimental data of the traditional Chinese medicine composition (Example 1) of the present invention in the treatment of insomnia

[0071] 1. General information:

[0072] A total of 101 insomnia patients admitted to the First People's Hospital of Kunshan from January 2021 to December 2022 were reviewed. The efficacy of the Anshen Patch was observed. They were randomly divided into two groups. There were 50 cases in the experimental group and 51 cases in the control group. In the control group, there were 25 males and 26 females, with an average age of (43.18 ± 7.11) years and an average disease course of (0.83 ± 0.23) years. In the experimental group, there were 23 males and 27 females, with an average age of (46.25 ± 6.14) years and an average disease course of (0.93 ± 0.26) years. When comparing the general information of the two groups of patients, the differences were not statistically significant (p > 0.05), and they were comparable.

[0073] 2. Treatment methods:

[0074] Those using the formula of this application (prepared from the traditional Chinese medicine composition described in Example 1) were in the experimental group, and those using the adjusted formula ① (prepared from the traditional Chinese medicine composition described in Comparative Example 1) were in the control group. They were applied to the bilateral Sanyinjiao acupoints in the form of essential oil acupoint application, used every night before going to bed, removed in the morning, applied for about 8 hours, once a night. The average treatment days in the experimental group were (20.3 ± 0.5) days, and the average treatment days in the control group were (21.9 ± 0.3) days. When comparing the treatment days of the general information of the two groups of patients, the differences were not statistically significant (p > 0.05), and they were comparable.

[0075] 3. Observation indicators:

[0076] The efficacy was judged based on the sleep time and the reduction rate of the Pittsburgh Sleep Quality Index (PSQI) score. Recovery: Sleep returned to normal or the nighttime sleep time was more than 6 hours, and the PSQI reduction rate > 75%; Marked effect: Sleep improved significantly, the sleep time increased by more than 3 hours, and most of the accompanying symptoms disappeared, 50% < PSQI reduction rate ≤ 75%; Effective: Sleep improved, but the increase in sleep time was less than 3 hours compared with before, 25% < PSQI reduction rate ≤ 50%; Ineffective: Sleep did not improve, the accompanying symptoms were not improved, and the PSQI reduction rate ≤ 25%. Adverse reactions included papules, congestion and swelling, itching and stinging, etc.

[0077] 4. Conclusion:

[0078] The total effective rate of the experimental group for clinical efficacy was 92.0%, which was higher than 80.4% of the control group, and the difference was statistically significant (p < 0.05). See Table 2. Before treatment, there was no statistically significant difference in the symptom and sign scores between the two groups of patients (p > 0.05). After treatment, the nocturnal sleep time of both groups of patients increased compared with that before treatment, and the control group was higher than the experimental group, with a statistically significant difference (P < 0.05), as shown in Table 3. The PSQI scores of both groups of patients decreased compared with those before treatment, and the control group was lower than the experimental group, with a statistically significant difference (p < 0.05), as shown in Table 4. Conclusion: The treatment with the traditional Chinese medicine composition of the present invention can improve the effective rate of insomnia treatment.

[0079] Table 2: Comparison of clinical efficacy between two groups of insomnia patients

[0080]

[0081] Note: The total effective rate = (cured + markedly effective + effective) / number of cases. The data of the two groups were compared by t-test. p < 0.05 for the comparison between the two groups, with a significant difference. There were no adverse reactions in all 101 cases of the control group and the experimental group.

[0082] Table 3: Comparison of nocturnal sleep time (score, x-±s)

[0083]

[0084] Note: Compared with before treatment in the same group, Δ p < 0.05; compared with after treatment in the control group, ▲ p < 0.05.

[0085] Table 4: Comparison of PSQI scores (score, x - ±s)

[0086]

[0087] Note: Compared with before treatment in the same group, Δ p < 0.05; compared with after treatment in the control group, ▲ p < 0.05. Example of preparation of essential oil patch:

[0088] Production method: Mix 30 mL of the formulated essential oil of the above components (for example, Examples 1-2) evenly, and then mix it evenly with 100 g of magnetite powder and 200 g of vaseline. Let it stand for about 1 hour. Take 0.5 g of the drug and place it in an empty PE film acupoint patch (6 cm * 6 cm, inner circle 2 cm * 2 cm). After pasting, it can be reserved for use.

[0089] Storage method: Store it refrigerated at 4°C in a sealed manner.

[0090] Use period: Within 30 days after production.

[0091] The essential oil acupoint application patch combines the advantages of traditional Chinese medicine and acupuncture. It has the effects of medicine, but is absorbed through the skin, without gastrointestinal reactions such as nausea and vomiting. Moreover, the medicine is mild, has no irritating effect, is easy to operate, and avoids the troubles that many people are afraid of acupuncture and it is difficult to find a good acupuncturist.

[0092] Obviously, the above embodiments are only examples for clearly illustrating the present invention, rather than limitations on the implementation manners of the present invention. Those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition with the function of calming the nerves, characterized in that: It is prepared from the following raw materials in parts by weight: 1-5 parts of sandalwood essential oil, 1-5 parts of lavender essential oil, 1-5 parts of Melaleuca alternifolia (Maiden & Betche) Cheel essential oil, 1-5 parts of rose essential oil, 1-5 parts of Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chow essential oil, 0.1-3 parts of peppermint essential oil, 0.1-3 parts of Astragalus membranaceus (Fisch.) Bunge essential oil, 1-5 parts of Coptis chinensis Franch. essential oil, 1-5 parts of cinnamon essential oil, and 200 parts of base oil, and the base oil is selected from one or more of the following: grape seed oil, sweet almond oil, jojoba oil or wheat germ oil.

2. The traditional Chinese medicine composition according to claim 1, wherein: It is prepared from the following raw materials in parts by weight: 1.5-2.5 parts of sandalwood essential oil, 1.5-2.5 parts of lavender essential oil, 1.5-2.5 parts of Melaleuca alternifolia (Maiden & Betche) Cheel essential oil, 1.5-2.5 parts of rose essential oil, 1.5-2.5 parts of Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chow essential oil, 0.5-1.5 parts of peppermint essential oil, 0.5-1.5 parts of Astragalus membranaceus (Fisch.) Bunge essential oil, 1.5-2.5 parts of Coptis chinensis Franch. essential oil, 1.5-2.5 parts of cinnamon essential oil, and 200 parts of base oil.

3. The traditional Chinese medicine composition according to claim 1, wherein: It is prepared from the following raw materials in parts by weight: 2 parts of sandalwood essential oil, 2 parts of lavender essential oil, 2 parts of Melaleuca alternifolia (Maiden & Betche) Cheel essential oil, 2 parts of rose essential oil, 2 parts of Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chow essential oil, 1 part of peppermint essential oil, 1 part of Astragalus membranaceus (Fisch.) Bunge essential oil, 2 parts of Coptis chinensis Franch. essential oil, 2 parts of cinnamon essential oil, and 200 parts of base oil.

4. The preparation method of the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: adding various essential oils into the base oil according to the parts by weight and fully mixing and stirring to obtain the product.

5. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine composition prepared by using the preparation method according to claim 4 in the preparation of a drug for preventing or treating insomnia.

6. The use according to claim 5, wherein: The drug is an external preparation.

7. The use according to claim 6, characterized in that: The external preparation is a nasal drops, a gel, an ointment, a patch, a liniment, a tincture, a lotion or a film-forming agent.

8. The use according to claim 6, wherein: The external preparation is an essential oil patch.

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