Traditional Chinese medicine acupoint patch for insomnia and anxiety and preparation method of traditional Chinese medicine acupoint patch

Abstract

The invention discloses a traditional Chinese medicine acupoint patch for insomnia and anxiety and a preparation method thereof. The traditional Chinese medicine acupoint patch mainly comprises 20 g of raw dens draconis and 10 g of schisandra chinensis. The auxiliary materials of the traditional Chinese medicine acupoint patch are medicinal powder, honey and corn oil. The preparation method comprises the following steps: crushing the raw dens draconis and the Chinese magnoliavine fruit into fine powder according to the prescription dosage, sieving with a 100-mesh sieve, uniformly mixing the medicinal powder, the honey and the corn oil according to the prescription proportion of 4.5: 6: 0.1, stirring into water-honeyed pills, sealing in plastic balls with the diameter of about 2.5 cm, and storing for later use. The traditional Chinese medicine acupoint patch has the advantages that the traditional Chinese medicine acupoint patch is simple to manufacture and operate, the sleep time of an insomnia patient is remarkably shortened, the sleep time is prolonged, the sleep quality, sleep disorder and depression emotion are improved, palpitation, fatigue, weakness symptoms and syncope feeling are relieved, the anxiety state is relieved, and the life quality of the patient is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine acupoint patch for insomnia and anxiety and a preparation method thereof. Background Art

[0002] Some current situations of insomnia and anxiety disorders in China at present:

[0003] Prevalence of insomnia disorder: Insomnia is one of the most common sleep disorders, and its incidence gradually increases with age. Among the elderly population over 60 years old, nearly half have complained of difficulty falling asleep or maintaining sleep, and 12% - 20% of them are diagnosed with sleep disorders. The survey results released by the Chinese Sleep Association show that about 300 million people in China have sleep disorders, and the population with completely no sleep disorders only accounts for 19%. Poor sleep quality can lead to the occurrence of multi-system diseases such as cardiovascular and cerebrovascular, mental psychology, cognitive memory, metabolism, and immunity. Sleep disorders have become an important problem that urgently needs to be solved in modern society.

[0004] Average sleep duration of Chinese residents: The "2024 White Paper on Sleep Health of Chinese Residents" shows that the average sleep duration of Chinese residents is only 6.75 hours, and as high as 28% of residents have a nighttime sleep duration of no more than 6 hours, far lower than the recommended healthy sleep time.

[0005] Diagnosis and treatment guidelines for insomnia: To standardize the diagnosis and treatment of insomnia in China, experts in related fields published the "Expert Consensus (Draft) on the Definition, Diagnosis, and Pharmacological Treatment of Insomnia in China" in 2006, and launched the "Diagnosis and Treatment Guidelines for Insomnia in Chinese Adults" in 2012, and updated the content of the guidelines in 2018 and 2024. These guidelines can provide comprehensive and standardized insomnia diagnosis and treatment plans for clinicians based on pharmacological treatment, psychotherapy, physical therapy, and traditional Chinese ethnic medicine treatment. However, the effectiveness and safety of long-term treatment plans still need to be verified.

[0006] High incidence and prevalence of anxiety disorders: Anxiety disorders are one of the most common mental health problems in today's society. According to statistics, about 4% of the global population is troubled by anxiety disorders. The results of the national epidemiological survey of mental disorders released in 2019 showed that the prevalence rate of anxiety disorders in China was 4.98%, ranking first among all mental disorders. At the same time, its lifetime prevalence rate is as high as 7.6%, which means that about 1 in every 13 Chinese adults has experienced anxiety disorders. Anxiety disorders have become a public health problem that cannot be ignored.

[0007] Diagnosis and Treatment Guidelines for Anxiety Disorders: To improve the diagnosis and treatment level of anxiety disorders in China, the Anxiety Disorders Collaborative Group of the Chinese Medical Association's Psychiatry Branch issued the "Chinese Guidelines for the Prevention and Treatment of Anxiety Disorders" in 2010 and updated it in 2023 in combination with the latest research progress at home and abroad. At present, there are still some bottleneck problems in anti-anxiety treatment, such as the clinical cure rate being lower than 30%, more drug adverse reactions, affecting treatment compliance, some patients interrupting treatment due to being unable to tolerate the adverse reactions, and the high price also increasing the economic burden on patients. Optimizing the treatment plan for anxiety disorders has become an important problem of common concern in society and the medical field.

[0008] Insomnia and anxiety often occur together, and the two are mutually causal, synergistically aggravating the condition. Epidemiological studies have shown that patients with insomnia accompanied by anxiety account for 20% - 30%, and 40% - 92% of insomnia symptoms are caused by mental illnesses. Insomnia is an independent risk factor for anxiety disorders. Long-term lack of sleep will weaken an individual's psychological stress ability and increase the risk of anxiety symptoms; conversely, anxiety disorders may also lead to persistent sleep disorders by affecting the neurotransmitter levels and brain activities of patients.

[0009] The comprehensive intervention of insomnia and anxiety is the key to disease treatment. The overall conditioning method of traditional Chinese medicine shows unique value in this field. The present invention can provide simple, convenient, effective, inexpensive, and safe treatment options for patients. Summary of the Invention

[0010] The purpose of the present invention is to provide a traditional Chinese medicine acupoint application preparation for treating insomnia and anxiety disorders and its preparation method. The main raw materials are composed of raw dragon's teeth and Schisandra chinensis, and the rest are auxiliary materials. The weight ratio of raw dragon's teeth to Schisandra chinensis is 2:1. The auxiliary materials of the traditional Chinese medicine acupoint patch are medicinal powder, honey, and corn oil.

[0011] Further, the raw dragon's teeth are 20g, and the Schisandra chinensis is 10g.

[0012] Further, this traditional Chinese medicine acupoint patch is placed on the Yongquan acupoint.

[0013] Currently, traditional Chinese medicine believes that the common pathogenesis of insomnia and anxiety is restlessness of the mind. Based on this, the present formula selects raw dragon's teeth that enter the heart and liver meridians to calm the mind and relieve uneasiness, and also to remove vexation; it is combined with Schisandra chinensis that soothes the nerves and calms the mind. The two medicines are used together, with simple ingredients and strong efficacy. They can not only make the mind calm and help with sleep; raw dragon's teeth are sweet and cool, and can also remove the dry-heat nature of those with anxiety disorders, and have good clinical efficacy.

[0014] Preparation method of traditional Chinese medicine acupoint application preparation for treating insomnia and anxiety disorders: Grind the prescribed amounts of raw dragon teeth and Schisandra chinensis into fine powder, pass through a 100-mesh sieve, mix the medicinal powder, honey, and corn oil according to the prescription ratio of 4.5:6:0.1, stir into honeyed pills, and store them sealed in plastic balls with a diameter of about 2.5 cm for later use. The dressing for acupoint application consists of a 5 cm * 5 cm base film, a 1 cm * 5 cm adhesive layer, a circular drug layer with a diameter of about 3 cm, and a 5 cm * 5 cm waterproof film.

[0015] In summary, the present invention has the following beneficial effects: 1. The production and operation of the present invention are both simple and inexpensive. 2. The present invention can relieve the tension and panic emotions of patients, reduce physical symptoms, improve the quality of life, and effectively improve the anxiety state of patients. At the same time, the present invention can also relieve the depression emotions of patients and physical symptoms such as palpitation and fatigue, improve the sleep quality, and show the potential to improve the depressive state. Specific embodiments

[0016] The following further elaborates on the present invention in combination with the embodiments: Clinical observation study on the improvement of insomnia and anxiety disorders in patients by Anshen Plaster.

[0017] 1 Research method: Single-arm clinical study

[0018] 2 Case source: Outpatients and inpatients of Xiyuan Hospital, China Academy of Chinese Medical Sciences.

[0019] 3 Inclusion criteria:

[0020] (1) Meet the diagnostic criteria for insomnia or anxiety disorders;

[0021] (2) Meet the diagnostic criteria for the syndrome of restlessness of the mind;

[0022] (3) Willing to accept the treatment of this study.

[0023] 4 Exclusion criteria

[0024] (1) Those with severe skin diseases or allergic to this product;

[0025] (2) Unwilling to accept the treatment of this study.

[0026] 5 Experimental drug: The application preparation provided by the present invention, including 20 g of raw dragon teeth, 10 g of Schisandra chinensis, and excipients. Preparation method of the present invention: Grind the prescribed amounts of raw dragon teeth and Schisandra chinensis into fine powder, pass through a 100-mesh sieve, mix the medicinal powder with 40 g of honey and 0.67 g of corn oil, stir into honeyed pills, and store them sealed in plastic balls with a diameter of about 2.5 cm for later use. The dressing for acupoint application consists of a 5 cm * 5 cm base film, a 1 cm * 5 cm adhesive layer, a circular drug layer with a diameter of about 3 cm, and a 5 cm * 5 cm waterproof film.

[0027] 6 Acupoint application operation method: The patient takes a sitting or supine position. The operator selects Yongquan acupoint, takes out the drug sealed in the plastic ball and places it on the dressing in advance. After cleaning the patient's skin, acupoint application treatment is carried out once a day for 6 - 8 hours each time.

[0028] 7 Observation indicators: Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS). The patients fill them out before acupoint application treatment and 2 weeks after treatment.

[0029] 8 Statistical methods: SPSS 25.0 is used for statistical analysis. Measurement data are expressed as mean ± standard deviation. For the comparison of two groups of data conforming to normal distribution, t-test is used; for the comparison of two groups of data not conforming to normal distribution, Wilcoxon signed-rank test is used. For count data, cross-tab chi-square test is used. When n≥40 and T≥5, chi-square test is used; when n≥40 and at least one 1≤T<5, corrected chi-square test is used; when n<40 or at least one T<1, Fisher's exact test is used. It is stipulated that P<0.05 indicates a statistically significant difference.

[0030] 9 Results:

[0031] 9.1 Pittsburgh Sleep Quality Index

[0032] A total of 30 patients with insomnia and anxiety were included in this study. The Wilcoxon signed-rank test was used to compare and analyze the results of the PSQI scale before and after acupoint application in patients. The results showed that after acupoint application treatment, the sleep quality, sleep onset time, sleep duration, sleep disorder and total PSQI score of the patients were lower than those before treatment, and the difference between the two groups was statistically significant (P<0.05). After treatment, the scores of sleep efficiency, use of hypnotic drugs and daytime dysfunction were lower than those before treatment, but the differences were not statistically significant (P = 0.056, P = 0.083, P = 0.097). It shows that acupoint application treatment can shorten the sleep onset time of patients, prolong the sleep duration, improve sleep quality and sleep disorder. At the same time, it also has the tendency to improve daytime dysfunction, improve sleep efficiency and reduce the use of hypnotic drugs. (See Table 1)

[0033] Table 1 Comparison of Pittsburgh Sleep Quality Index scores before and after treatment in patients

[0034]

[0035] Note: P is the result of between-group difference comparison using Wilcoxon signed-rank test; *Indicates that the difference is statistically significant with P < 0.05

[0036] 9.2 Self-Rating Anxiety Scale

[0037] The Wilcoxon signed-rank test was used to compare and analyze the results of the SAS scale before and after acupoint application in patients. The results showed that after treatment, the scores of items 1, 3, 5, 7, 8, 10, 15, 20 and the total score of the SAS scale in patients were lower than those before treatment, and the difference between the two groups was statistically significant (P < 0.05). It indicates that acupoint application treatment can relieve the tension and panic emotions of patients, improve physical symptoms, and improve the quality of life. (See Table 2)

[0038] Table 2 Comparative analysis of SAS scale scores in patients before and after treatment

[0039]

[0040] Table 2 Comparative analysis of SAS scale scores in patients before and after treatment (continued)

[0041]

[0042] Note: P is the result of the between-group difference comparison using the Wilcoxon signed-rank test; * Indicates that the difference is statistically significant with P < 0.05

[0043] The chi-square test was used to compare and analyze the SAS grading of patients before and after acupoint application. The results showed that the number of patients with mild anxiety, moderate anxiety and severe anxiety decreased after treatment, and the difference before and after treatment was statistically significant (P < 0.05). It indicates that acupoint application treatment can improve the anxiety state of patients. (See Table 3)

[0044] Table 3 Comparative analysis of SAS grading in patients before and after treatment

[0045]

[0046] Note: P is the result of the between-group difference comparison using the chi-square test; * Indicates that the difference is statistically significant with P < 0.05

[0047] 9.3 Self-Rating Depression Scale

[0048] The Wilcoxon signed-rank test was used to compare and analyze the results of the SDS scale before and after acupoint application in patients. The results showed that after treatment, the scores of items 1, 2, 3, 4, 9, 10, 14, 15, 16 and the total score in patients were lower than those before treatment, and the difference between the two groups was statistically significant (P < 0.05). It indicates that acupoint application treatment can relieve the depression emotions of patients, improve physical symptoms such as palpitations and fatigue, and improve sleep quality and quality of life. (See Table 4)

[0049] Comparative Analysis of SDS Scale Scores of Patients before and after Treatment

[0050]

[0051] Note: P is the result of the between-group difference comparison using the Wilcoxon signed-rank test; * Indicates that P < 0.05, and the difference is statistically significant

[0052] The chi-square test was used to compare and analyze the SDS grades of patients before and after acupoint application. The results showed that the number of patients with mild depression, moderate depression, and severe depression all decreased after treatment, but the difference before and after treatment was not statistically significant (P = 0.096). It indicates that acupoint application has a tendency to improve the depressive state. (See Table 5)

[0053] Comparative Analysis of SDS Grades of Patients before and after Treatment

[0054]

[0055] Note: P is the result of the between-group difference comparison using the chi-square test

[0056] The results show that the present invention can relieve the tension and panic emotions of patients, reduce physical symptoms, improve the quality of life, and effectively improve the anxiety state of patients. At the same time, the present invention can also relieve the depressive emotions of patients and physical symptoms such as palpitation and fatigue, improve the sleep quality, and show the potential to improve the depressive state.

[0057] This specific embodiment is only used to explain the present invention and is not a limitation of the present invention. After reading this specification, those skilled in the art can make modifications to this embodiment that do not involve creative contributions according to needs, but as long as it is within the scope of the claims of the present invention, it is protected by the patent law.

Claims

1. A Chinese medicine acupoint patch for insomnia and anxiety, characterized in that: The raw material medicine is composed of raw dragon tooth, schisandra chinensis and auxiliary materials, and the weight ratio of raw dragon tooth to schisandra chinensis is 2:

1.

2. The Chinese medicine acupoint patch for insomnia and anxiety according to claim 1, characterized in that: The raw dragon tooth is 20g and the Schisandra chinensis is 10g.

3. The Chinese medicine acupoint patch for insomnia and anxiety according to claim 1, characterized in that: The auxiliary materials of Chinese medicine acupoint patch are medicine powder, honey and corn oil.

4. The Chinese medicine acupuncture patch for insomnia and anxiety according to claim 2, characterized in that: The acupoint patch preparation is placed on the Yongquan acupoint.

5. A method for preparing a Chinese medicine acupoint patch for insomnia and anxiety, characterized in that: The preparation method comprises the following steps:

1. crushing the prescribed amount of raw dragon tooth and schisandra chinensis into fine powder and passing through a 100-mesh sieve; 2. mixing the powder, honey and corn oil, stirring them into water-honey pills, sealing them in a plastic ball with a diameter of about 2.5 cm and storing them for later use; 3. the acupoint application dressing consists of a 5cm*5cm base film, a 1cm*5cm adhesive layer, a circular drug layer with a diameter of about 3cm, and a 5cm*5cm waterproof film.

6. The method for preparing a Chinese medicine acupoint application preparation for treating insomnia and anxiety disorders according to claim 6, characterized in that: The ratio of medicinal powder, honey and corn oil is 4.5:6:0.1.

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