Application traditional Chinese medicine composition for treating insomnia

Abstract

The invention discloses an application traditional Chinese medicine composition for treating insomnia. The traditional Chinese medicine composition comprises coptis chinensis, lily, poria with hostwood, rhizoma acori graminei, prepared polygala tenuifolia, prepared fructus evodiae, cinnamon, mint and the like. The traditional Chinese medicine patch comprises a spunlace non-woven fabric blank patch and an extract coated in the middle of the spunlace non-woven fabric blank patch, the extract comprises an active component and a dressing, and the active component can be powder obtained by crushing a traditional Chinese medicine composition and can also be an extract of the traditional Chinese medicine composition. According to the traditional Chinese medicine composition, the coptis chinensis, the coptis chinensis-prepared fructus evodiae and the coptis chinensis-cortex cinnamomi are mainly used for guiding fire to the origin, the lily and the poria with hostwood are matched for clearing away the heart-fire and calming the nerves, the rhizoma acori graminei and the prepared polygala tenuifolia are used for traffic of the heart and the kidney, and the fragrant mint is used for assisting in improving the effects of the medicines. All the medicines are compatible and complement each other to jointly achieve the effects of regulating the heart and kidney, soothing the nerves and helping sleep, and the traditional Chinese medicine has the advantages of being good in nerve soothing and sleep helping effect, remarkable in effect, exact in medicine effect and high in effect taking speed and has excellent clinical application and popularization value.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a Chinese medicine composition for applying for treating insomnia. Background Art

[0002] With the rapid development of modern society and economy, more and more people are suffering from insomnia. WHO research shows that almost 30% of people in the world suffer from insomnia, which is recognized as one of the public health problems that has not been fully valued and well solved in the world.

[0003] At present, the main Western medicines for the clinical treatment of insomnia include benzodiazepines Drugs, non-benzodiazepines There are many types of drugs for insomnia, such as antidepressants, melatonin receptor agonists, and antidepressants with hypnotic effects. Although there are many drug treatments for insomnia, there are still some limitations. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating insomnia, so as to solve the problems of dependence and addiction, side effects, unstable efficacy and limited long-term effect when using existing drugs to treat insomnia.

[0005] The objective of the present invention is achieved through the following technical solutions:

[0006] <First aspect>

[0007] The invention provides a traditional Chinese medicine composition, comprising coptis root, processed evodia rutaecarpa, cinnamon bark, lily, poria, calamus, processed polygala root and mint.

[0008] "When yang enters yin, one sleeps; when yang leaves yin, one wakes up." Insomnia is caused by the failure of yang to communicate with yin. The heart is a fire organ, the yang among yang, and the kidney is a water organ, the yin among yin. If the heart fire is too strong and cannot communicate with the kidney, it will be difficult to fall asleep; if the kidney yang is insufficient and cannot draw up the heart fire, one will not sleep deeply; if phlegm and dampness are generated internally, the communication between the heart and kidney is blocked, which can cause snoring. Therefore, the prescription uses coptis root and lily to clear the heart fire, nourish the heart yin, and directly suppress the upward fire. It also uses cinnamon and evodia rutaecarpa to warm the kidney yang, reduce the virtual fire, and guide the fire back to the origin; it is matched with the mild poria as a messenger to nourish the heart qi and calm the mind; in order to promote the penetration of the application, the prescription is supplemented with aromatic mint to increase the efficacy of the medicines, so as to achieve the effect of communicating the heart and kidney, guiding the yang to communicate with the yin, and calming the mind and helping sleep.

[0009] Modern pharmacology shows that Coptis chinensis contains rich alkaloid components, among which berberine is the most representative. Studies have shown that the active ingredients in Coptis chinensis can penetrate the blood-brain barrier and inhibit the central nervous system, thereby reducing the excitability of the nervous system and helping to improve sleep quality. Coptis chinensis may exert a sedative and hypnotic effect by regulating the levels of neurotransmitters in the brain, such as γ-aminobutyric acid (GABA). GABA is an important inhibitory neurotransmitter in the central nervous system and is closely related to the regulation of the sleep-wake cycle. Lily mainly contains biologically active ingredients such as steroidal saponins, polysaccharides, alkaloids and phenols. Modern pharmacology shows that lily saponins may be the main pharmacological material basis for lily to exert its sedative and hypnotic effect. Poria contains polysaccharides, triterpenes, gums, proteins and fatty acids, as well as ergosterol, choline, adenine, lecithin, histidine, pachymannan decomposing enzymes, proteases and inorganic elements such as calcium, magnesium, phosphorus, iron, sodium, potassium and manganese. It has sedative, hypnotic, heart-nourishing and tranquilizing effects, and can counteract the excited state caused by caffeine, so it is used for neurasthenia, insomnia, and dreaminess. In addition to treating insomnia, modern applications of Poria can also be used for mental system diseases with emotional or mental disorders as the main manifestations. Studies have found that the decoction of Acorus calamus and the de-oiled decoction can significantly reduce the spontaneous activity of mice, and have a significant synergistic effect with subthreshold hypnotic doses of sodium pentobarbital. At the same time, the extract of the ethyl acetate part of Polygala tenuifolia has a central sedative, hypnotic and anti-anxiety effect on mice with subthreshold hypnotic doses of sodium pentobarbital. Polygala tenuifolia can exert an inhibitory effect on the central nervous system of mice by synergizing with sodium pentobarbital. Application of Yongquan acupoints with Evodia rutaecarpa can improve the sleep quality of patients with insomnia, and berberine is the main effective compound for its therapeutic effect. It mainly acts on key genes such as CRP, IL-6, and 5-HT, and then exerts sedative, hypnotic, and anti-anxiety and depression effects through various neurotransmitter receptors, synaptic cell components, and ligand-receptor interaction signal transduction pathways. Modern research has found that cinnamaldehyde contained in cinnamon has a significant sedative effect on mice, which is manifested as a decrease in spontaneous activity. Wu Mingxia et al. used thin layer chromatography to identify and compare the chemical components of coptis chinensis, cinnamon, and combined use, and found that compared with single herbs, the berberine content of "coptis chinensis-cinnamon" combined use was significantly reduced, but the content of sedative and hypnotic components (cinnamaldehyde) was significantly increased.

[0010] As a unique ingredient in topical medicines, mint is pungent and cool in nature, and enters the lung and liver meridians. The volatile oil components contained in mint, such as menthol and menthol, can promote drug penetration through structural changes in the stratum corneum lipids, thereby improving transdermal absorption. This lays a good foundation for the topical application of acupoint patching.

[0011] The present invention reasonably matches the above components, and the drug formula is rigorous, and the pathogenesis of insomnia is accurately determined: yang does not communicate with yin, and the mind is restless. The main pathogenesis is used to play the function of connecting the heart and kidney, calming the nerves and helping sleep. Through clinical data verification, the clinical efficacy of the prescription is definite, and no obvious adverse reactions and toxic side effects are observed. The Chinese medicine composition of the present invention can shorten the sleep latency, reduce the number of awakenings, improve the patient's sleep efficiency, and improve the sleep quality by connecting the heart and kidney, calming the nerves and helping sleep, thereby alleviating clinical symptoms.

[0012] As an embodiment of the present invention, the composition comprises 15-50 parts of coptis root, 3-9 parts of processed evodia rutaecarpa, 3-6 parts of cinnamon bark, 6-30 parts of lily, 10-30 parts of poria, 3-10 parts of calamus, 3-10 parts of processed polygala tenuifolia and 3-6 parts of mint.

[0013] As one embodiment of the present invention, a clinically acceptable pharmaceutical preparation is prepared according to a conventional preparation method of a traditional Chinese medicine composition.

[0014] As an embodiment of the present invention, the pharmaceutical preparation is an external dosage form.

[0015] As an embodiment of the present invention, the external dosage form is an ointment, a paste, a powder or a gel.

[0016] <Second Aspect>

[0017] The present invention also provides an application of the traditional Chinese medicine composition in preparing a medicine for preventing and / or treating insomnia.

[0018] <Third Aspect>

[0019] The present invention also provides a medicine for preventing and / or treating insomnia, wherein the medicine is prepared from the above-mentioned traditional Chinese medicine composition.

[0020] As an embodiment of the present invention, the medicament further comprises a pharmaceutically acceptable adjuvant.

[0021] <Fourth Aspect>

[0022] The present invention also provides a Chinese medicine patch for preventing and / or treating insomnia, wherein the Chinese medicine patch is made of the above-mentioned Chinese medicine composition.

[0023] As an embodiment of the present invention, the Chinese medicine patch includes a spunlace non-woven fabric blank patch and an extract coated on the spunlace non-woven fabric blank patch; the extract includes an active ingredient and a dressing, and the active ingredient is the Chinese medicine composition.

[0024] As an embodiment of the present invention, the active ingredient is the powder of the Chinese medicine composition after being crushed, or is the extract of the Chinese medicine composition.

[0025] In some specific implementation examples, the raw materials in the above-mentioned traditional Chinese medicine composition are crushed, passed through an 80-100 mesh drying net, and the powder is mixed evenly for use; an appropriate amount of vaseline is added to the powder, mixed evenly, and a soft material is prepared; pills with a diameter of 2-3 cm are prepared according to needs, and a blank patch is placed therein.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] 1) The Chinese medicine composition of the present invention can improve the clinical symptoms of insomnia patients, shorten the sleep latency, reduce the number of awakenings, improve the patients' sleep efficiency, and improve sleep quality.

[0028] 2) The Chinese medicine composition of the present invention reuses coptis root, coptis root-processed evodia rutaecarpa, coptis root-cinnamon double drug pair to guide fire back to the origin, and is further matched with lily and poria to calm the mind, calamus and processed polygala to connect the heart and kidney, and is supplemented with aromatic mint to enhance the effects of the various drugs. The compatibility of the various drugs complements each other, and together play the role of connecting the heart and kidney, calming the mind and helping sleep, with good calming and helping sleep effect, quick effect, and has the advantages of significant effect, definite efficacy, quick effect, and small side effects. DETAILED DESCRIPTION

[0029] The present invention is described in detail below in conjunction with embodiments. The following embodiments will help those skilled in the art to further understand the present invention, but are not intended to limit the present invention in any form. It should be noted that, for those of ordinary skill in the art, some adjustments and improvements can also be made without departing from the concept of the present invention. These all belong to the protection scope of the present invention.

[0030] Example 1

[0031] This embodiment relates to a traditional Chinese medicine composition, including 15 parts of coptis root, 3 parts of processed evodia rutaecarpa, 3 parts of cinnamon bark, 10 parts of lily, 15 parts of poria, 9 parts of calamus, 6 parts of processed polygala and 3 parts of mint.

[0032] The present embodiment also relates to a Chinese medicine patch for preventing and / or treating insomnia containing the above composition, and the Chinese medicine patch includes a spunlace non-woven fabric blank patch. The raw materials in the above Chinese medicine composition are crushed, passed through an 80-mesh drying net, and the powder is mixed evenly for use; the powder is added with an appropriate amount of vaseline, mixed evenly, and a soft material is prepared; pills with a diameter of 2-3 cm are prepared according to needs and placed in the patch.

[0033] Example 2

[0034] This embodiment relates to a traditional Chinese medicine composition, including 50 parts of coptis root, 9 parts of processed evodia rutaecarpa, 6 parts of cinnamon bark, 20 parts of lily, 20 parts of poria, 10 parts of calamus, 10 parts of processed polygala tenuifolia and 5 parts of mint.

[0035] This embodiment also relates to a Chinese medicine patch for preventing and / or treating insomnia containing the above composition, and the Chinese medicine patch includes a spunlace non-woven fabric blank patch. The raw materials in the above Chinese medicine composition are crushed, passed through a 100-mesh drying net, and the powder is mixed evenly for use; the powder is added with an appropriate amount of vaseline, mixed evenly, and a soft material is prepared; pills with a diameter of 2-3 cm are prepared according to needs and placed in the patch.

[0036] Example 3

[0037] This embodiment relates to a traditional Chinese medicine composition, including 30 parts of coptis root, 5 parts of processed evodia rutaecarpa, 3 parts of cinnamon bark, 30 parts of lily, 30 parts of poria, 9 parts of calamus, 6 parts of processed polygala and 6 parts of mint.

[0038] The present embodiment also relates to a Chinese medicine patch for preventing and / or treating insomnia containing the above composition, and the Chinese medicine patch includes a spunlace non-woven fabric blank patch. The raw materials in the above Chinese medicine composition are crushed, passed through an 80-mesh drying net, and the powder is mixed evenly for use; the powder is added with an appropriate amount of vaseline, mixed evenly, and a soft material is prepared; pills with a diameter of 2-3 cm are prepared according to needs and placed in the patch.

[0039] Example 4

[0040] This embodiment relates to a traditional Chinese medicine composition, including 25 parts of coptis root, 5 parts of processed evodia rutaecarpa, 5 parts of cinnamon bark, 15 parts of lily, 15 parts of poria, 10 parts of calamus, 10 parts of processed polygala tenuifolia and 5 parts of mint.

[0041] The present embodiment also relates to a Chinese medicine patch for preventing and / or treating insomnia containing the above composition, and the Chinese medicine patch includes a spunlace non-woven fabric blank patch. The raw materials in the above Chinese medicine composition are crushed, passed through an 80-mesh drying net, and the powder is mixed evenly for use; the powder is added with an appropriate amount of vaseline, mixed evenly, and a soft material is prepared; pills with a diameter of 2-3 cm are prepared according to needs and placed in the patch.

[0042] Example 5

[0043] This embodiment relates to a traditional Chinese medicine composition, including 40 parts of coptis root, 8 parts of processed evodia rutaecarpa, 5 parts of cinnamon bark, 20 parts of lily, 15 parts of poria, 9 parts of calamus, 6 parts of processed polygala tenuifolia and 4 parts of mint.

[0044] This embodiment also relates to a Chinese medicine patch for preventing and / or treating insomnia containing the above composition, and the Chinese medicine patch includes a spunlace non-woven fabric blank patch. The raw materials in the above Chinese medicine composition are crushed, passed through a 100-mesh drying net, and the powder is mixed evenly for use; the powder is added with an appropriate amount of vaseline, mixed evenly, and a soft material is prepared; pills with a diameter of 2-3 cm are prepared according to needs and placed in the patch.

[0045] Comparative Example 1

[0046] This comparative example relates to a Chinese medicine composition, including 30 parts of coptis root, 5 parts of processed evodia rutaecarpa, 3 parts of cinnamon bark, 30 parts of lily, 30 parts of spiny jujube seeds, 30 parts of tuberculosis, 9 parts of calamus, 6 parts of processed polygala and 6 parts of mint. Among them, 30 parts of spiny jujube seeds and 30 parts of tuberculosis are recommended for the best effect.

[0047] The method for preparing the Chinese medicine patch is basically the same as that in Example 1.

[0048] Comparative Example 2

[0049] This comparative example relates to a traditional Chinese medicine composition, comprising 40 parts of coptis root, 20 parts of lily, 15 parts of poria, 9 parts of calamus, 6 parts of processed polygala and 4 parts of mint.

[0050] The method for preparing the Chinese medicine patch is basically the same as that in Example 2.

[0051] Comparative Example 3

[0052] This comparative example relates to a traditional Chinese medicine composition, comprising 6 parts of coptis root, 6 parts of processed evodia rutaecarpa, 6 parts of cinnamon bark, 15 parts of lily, 15 parts of poria, 10 parts of calamus, 10 parts of processed polygala tenuifolia and 5 parts of mint.

[0053] The method for preparing the Chinese medicine patch is basically the same as that in Example 1.

[0054] Comparative Example 4

[0055] This comparative example relates to a Chinese medicine composition, comprising 30 parts of lily, 15 parts of poria, 10 parts of calamus, 10 parts of processed polygala and 5 parts of mint. Among them, 30 parts of lily is the recommended optimal dosage.

[0056] The method for preparing the Chinese medicine patch is basically the same as that in Example 1.

[0057] Comparative Example 5

[0058] This comparative example relates to a traditional Chinese medicine composition, comprising 20 parts of processed Evodia rutaecarpa, 30 parts of lily, 30 parts of Poria, 9 parts of Acorus calamus, 6 parts of processed Polygala tenuifolia and 6 parts of mint.

[0059] The method for preparing the Chinese medicine patch is basically the same as that in Example 1.

[0060] Comparative Example 6

[0061] This comparative example relates to a traditional Chinese medicine composition, comprising 15 parts of cinnamon bark, 30 parts of lily, 30 parts of poria, 9 parts of calamus, 6 parts of processed polygala and 6 parts of mint.

[0062] The method for preparing the Chinese medicine patch is basically the same as that in Example 1.

[0063] Comparative Example 7

[0064] This comparative example relates to a traditional Chinese medicine composition, comprising 10 parts of coptis root, 10 parts of processed evodia rutaecarpa, 2 parts of cinnamon bark, 15 parts of lily, 15 parts of poria, 10 parts of calamus, 10 parts of processed polygala root and 5 parts of mint.

[0065] The method for preparing the Chinese medicine patch is basically the same as that in Example 1.

[0066] Efficacy verification example

[0067] Clinical trial plan:

[0068] 1. Materials and Methods

[0069] 1. Research subjects

[0070] This trial adopted a randomized, double-blind, placebo-controlled parallel method, followed the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT), and selected 96 patients with depressive disorder-related insomnia who were outpatients or inpatients of the Department of Neurology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine and were willing to follow the treatment methods, including 48 patients in the treatment group and 48 patients in the control group.

[0071] 2. Inclusion criteria:

[0072] ①Age 18-65, no gender limitation;

[0073] ② The main complaint is insomnia, which meets the diagnosis of insomnia in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) ①-⑦;

[0074] ③Meet the diagnostic criteria for mild to moderate depression in the International Classification of Diseases (ICD-10), with a Hamilton Depression Rating Scale (17-item version) score ≥ 7 points and ≤ 24 points.

[0075] ④ Meet the TCM diagnostic criteria for insomnia and depression (refer to the "TCM Internal Medicine Common Diseases Diagnosis and Treatment Guidelines Part on TCM Diseases and Syndromes" ZYYXH / T4~49-2008, issued by the China Association of Traditional Chinese Medicine and published by China Traditional Chinese Medicine Press in 2008)), and meet the diagnostic criteria for the syndrome of heart and gallbladder qi deficiency (refer to the "TCM Clinical Diagnosis and Treatment Terminology Part on Syndromes" GB / T16751.2-1997).

[0076] ⑤The cumulative score of the seven factors of the Pittsburgh Sleep Quality Index (PSQI) is greater than 7 points.

[0077] ⑥ Participate voluntarily and sign the informed consent.

[0078] 3. Exclusion criteria:

[0079] ①Does not meet the above diagnostic criteria and inclusion criteria;

[0080] ② Patients with severe depression, with a baseline Hamilton Depression Rating Scale score of >24, or patients with a history of suicide attempts or current high suicide risk;

[0081] ③ Secondary insomnia, environmental sleep disorders, sleep apnea syndrome; depression caused by depression secondary to other mental illnesses or physical diseases;

[0082] ④ Patients with serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, mental illness or patients with serious suicidal tendencies;

[0083] ⑤Those with alcohol dependence and drug abuse within one year before screening;

[0084] ⑥ Pregnant and lactating women;

[0085] ⑦ Subjects who have participated in or are currently participating in other drug clinical trials within 3 months prior to enrollment;

[0086] ⑧Patients with other conditions that the researcher believes are not eligible for screening.

[0087] 4. Medication regimen

[0088] Both the treatment group and the control group were treated with alprazolam (alprazolam tablets (Shandong Xinyi Pharmaceutical Co., Ltd.), 0.4 mg, once a night, 1 tablet each time, orally) and were required to be relatively stable for at least 3 months before this clinical trial.

[0089] ① Treatment group (anti-depression and sleep-aiding patch group) (48 people): oral alprazolam tablets + external anti-depression and sleep-aiding patch;

[0090] Medication method: Oral alprazolam tablets (0.4 mg once a night) + external depression-relieving and sleep-aiding patch;

[0091] Usage and dosage of depression-relieving and sleep-aiding patch: grind the Chinese medicinal materials in the above embodiments and comparative examples respectively, pass through an 80-mesh drying net, mix the powders evenly, add an appropriate amount of vaseline, mix evenly, and make soft pills with a diameter of 1 cm. Apply to the Laogong and Yongquan points on both sides 1 hour before going to bed, once every night, for 8 hours each time. 8 weeks is a course of treatment.

[0092] ②Control group (48 people): simply take alprazolam tablets orally.

[0093] Dosage: Oral alprazolam tablets (0.4 mg once every night).

[0094] 2. Results

[0095] 2.1 The depression-relieving and sleep-aiding patch of Example 1 was used. After the treatment was completed, the treatment effects of the treatment group and the control group were shown in the following Tables 1-6.

[0096] (1) Changes in sleep latency before and after treatment

[0097]

[0098]

[0099] Note: A: 10-30 minutes, B: 30-60 minutes, C: 1-2 hours, D: more than 2 hours.

[0100] (2) Changes in sleep duration before and after treatment

[0101]

[0102] Note: A: 7-8 hours, B: 6-7 hours, C: 5-6 hours, D: 3-5 hours, E: <3 hours. (3) Changes in sleep maintenance before and after treatment

[0103]

[0104]

[0105] (4) Changes in daytime function before and after treatment

[0106]

[0107] Note: A: feeling very good, B: feeling better, C: feeling OK, D: feeling bad, E: feeling very bad.

[0108] (5) PSQI scores before and after treatment

[0109]

[0110] (6) HAMD scores before and after treatment

[0111]

[0112] 2.2 The depression-relieving and sleep-aiding patches of Examples 2-5 and Comparative Examples 1-7 were used. After the treatment, the PSQI scores and HAMD scores were shown in Tables 7 and 8 below, respectively.

[0113]

[0114]

[0115]

[0116] The experiment shows that compared with the comparative example, the Chinese medicine composition and Chinese medicine application for treating insomnia provided in the embodiment of the present invention can reduce the total score of the Pittsburgh Sleep Quality Index, shorten the sleep latency, increase the sleep duration, reduce the number of awakenings at night, and improve daytime dysfunction. In the Hamilton Depression Rating Scale (HAMD) evaluation, the embodiment of the present invention can reduce the total score of HAMD, indicating that the present invention can improve the depression of insomnia patients.

[0117] The results of the above examples 1-5 and comparative examples 1-7 show that the present invention reuses coptis root as a feature, and combines coptis root-prepared evodia rutaecarpa and coptis root-cinnamon to synergistically enhance the effect of guiding fire back to the origin and guiding yang into yin, which can effectively relieve and treat the symptoms of irritability and insomnia, shorten the sleep latency, and increase the sleep duration. At the same time, the combination of lily and poria plays the role of clearing the heart, eliminating irritability, and calming the mind, thereby improving the sleep quality and improving the patient's mood and daytime dysfunction.

[0118] The above describes the specific embodiments of the present invention. It should be understood that the present invention is not limited to the above specific embodiments, and those skilled in the art may make various modifications or variations within the scope of the claims, which do not affect the essence of the present invention.

Claims

1. A Chinese medicine composition comprising coptis root, processed evodia rutaecarpa, cinnamon bark, lily, poria, calamus, processed polygala root and mint.

2. The Chinese medicine composition according to claim 1, characterized in that: The composition comprises 15-50 parts of coptis root, 3-9 parts of processed evodia rutaecarpa, 3-6 parts of cinnamon bark, 6-30 parts of lily, 10-30 parts of poria, 3-10 parts of calamus, 3-10 parts of processed polygala root and 3-6 parts of mint.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: The conventional preparation method of Chinese medicine composition is used to prepare a clinically acceptable pharmaceutical preparation.

4. The Chinese medicine composition according to claim 3, characterized in that: The pharmaceutical preparation is an external dosage form.

5. The Chinese medicine composition according to claim 4, characterized in that: The external dosage form is ointment, paste, powder or gel.

6. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for preventing and / or treating insomnia.

7. A drug for preventing and / or treating insomnia, characterized in that: The medicine is prepared from the Chinese medicine composition according to claim 1 or 2; the medicine also includes a pharmaceutically acceptable adjuvant.

8. A Chinese medicine patch for preventing and / or treating insomnia, characterized in that: The Chinese medicine patch is made of the Chinese medicine composition according to claim 1 or 2.

9. The Chinese medicine patch for preventing and / or treating insomnia according to claim 8, characterized in that: The Chinese medicine patch comprises a spunlace non-woven fabric blank patch and an extract coated on the spunlace non-woven fabric blank patch; the extract comprises an active ingredient and a dressing, and the active ingredient is the Chinese medicine composition.

10. The Chinese medicine patch for preventing and / or treating insomnia according to claim 8, characterized in that: The active ingredient is the powder of the pulverized traditional Chinese medicine composition, or is the extract of the traditional Chinese medicine composition.

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