Application of traditional Chinese medicine composition in preparation of medicine for soothing nerves and helping sleep

Abstract

The invention discloses a nerve soothing and sleep aiding formula which is prepared from the following components in parts by mass: 15 to 30 parts of albizia flower, 15 to 30 parts of polygala tenuifolia, 20 to 40 parts of tuber fleeceflower stem, 15 to 30 parts of angelica sinensis, 15 to 30 parts of mint, 15 to 30 parts of clove, 10 to 20 parts of poria cocos and 10 to 20 parts of poria with hostwood. The formula comprises the following components in parts by mass: 15 to 30 parts of albizia flower, 15 to 30 parts of polygala tenuifolia, 20 to 40 parts of tuber fleeceflower stem, 15 to 30 parts of angelica sinensis, 15 to 30 parts of mint, 15 to 30 parts of clove, 10 to 20 parts of poria cocos and 10 to 20 parts of poria with hostwood. The prescription has the effects of tranquilizing mind by nourishing the heart, soothing liver-qi stagnation and promoting circulation of heart and kidney, and is suitable for insomnia caused by liver depression, blood deficiency and heart-spleen deficiency. Clinical tests show that through foot bath administration, the sleep quality can be remarkably improved, the sleep time can be shortened, the sleep efficiency can be improved, the anxiety mood can be relieved, and the safety is good.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to the application of a traditional Chinese medicine composition in the preparation of sedative and sleep-aiding drugs. Background Technology

[0002] Insomnia is a common sleep disorder characterized by frequent and persistent difficulty falling asleep and maintaining sleep. It can lead to daytime fatigue, decreased attention, and mood disturbances, severely impacting patients' quality of life. In specific situations, such as before surgery, patients often experience significant anxiety due to worry and fear about the operation, which can trigger or worsen insomnia; this is known as "preoperative anxiety insomnia." If this type of insomnia is not effectively intervened, it may affect the patient's physiological homeostasis, increase intraoperative risks, and delay postoperative recovery.

[0003] Currently, clinical interventions for insomnia mainly include pharmacological and non-pharmacological treatments. Pharmacological treatment primarily uses benzodiazepines and non-benzodiazepines as sedative-hypnotics. Although they have a rapid onset of action, they carry potential risks such as drug tolerance, dependence, daytime sleepiness, and impaired cognitive function. Non-pharmacological treatments, such as cognitive behavioral therapy, are effective but have a long treatment course and are limited in situations with limited pre-operative time.

[0004] Traditional Chinese medicine (TCM) has a long history and unique advantages in treating insomnia, emphasizing holistic diagnosis and individualized treatment, often using oral decoctions for conditioning. However, traditional oral TCM has problems such as poor taste, inconvenience in decoction preparation, and potential gastrointestinal discomfort for some patients, making patient compliance difficult to guarantee. Furthermore, for insomnia with complex pathogenesis induced by specific situations such as preoperative stress, some existing TCM formulas either focus on sedation and tranquilization or emphasize tonification; there is still room for improvement in the synergistic effect of quickly relieving emotional tension and improving sleep quality.

[0005] Therefore, there is an urgent clinical need for a traditional Chinese medicine intervention program that is relatively fast-acting, convenient to use, has few side effects, and can specifically regulate insomnia caused by liver stagnation and blood deficiency, as well as deficiency of both heart and spleen. External treatments, such as herbal foot baths, exert their effects through skin absorption and meridian conduction, avoiding the first-pass effect of the liver and gastrointestinal irritation, providing a safe and convenient route of administration for insomnia treatment. However, not all sedative Chinese medicines are suitable for or have been verified to effectively exert systemic sedative effects through foot baths, and research on foot bath formulas specifically for preoperative anxiety is still insufficient. Summary of the Invention

[0006] To address the problems existing in the prior art, this invention provides an application of a traditional Chinese medicine composition in the preparation of a sedative and sleep-aiding drug. The composition includes: Albizia julibrissin flower, Polygala tenuifolia root, Polygonum multiflorum stem, Angelica sinensis root, Mentha haplocalyx, Syzygium aromaticum root, Poria cocos, and Poria cocos sclerotium root. This composition has the effects of nourishing the heart and calming the mind, soothing the liver and relieving depression, and harmonizing the heart and kidneys. It is suitable for insomnia, excessive dreaming, irritability, and difficulty falling asleep caused by emotional distress or excessive thinking, and is especially suitable for short-term sleep disorders induced by preoperative anxiety and other factors. It has good safety.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solutions.

[0008] This invention discloses a traditional Chinese medicine composition with calming and sleep-aiding effects, characterized in that it is composed of the following raw materials in parts by weight: 15-30 parts of Albizia julibrissin flower, 15-30 parts of Polygala tenuifolia, 20-40 parts of Polygonum multiflorum stem, 15-30 parts of Angelica sinensis, 15-30 parts of Mentha haplocalyx, 15-30 parts of Syzygium aromaticum, 10-20 parts of Poria cocos, and 10-20 parts of Poria cocos sclerotium.

[0009] Furthermore, it is composed of the following raw materials in parts by weight: 20 parts of Albizia julibrissin flower, 20 parts of Polygala tenuifolia, 30 parts of Polygonum multiflorum stem, 20 parts of Angelica sinensis, 20 parts of Mentha haplocalyx, 20 parts of Syzygium aromaticum, 15 parts of Poria cocos, and 15 parts of Poria cocos sclerotium.

[0010] The present invention also discloses a method for preparing the traditional Chinese medicine composition described in any one of the above claims, characterized by comprising the following steps: mixing the raw materials, soaking in water for 5-30 minutes, then heating and decocting for 20-60 minutes, filtering, and obtaining the medicinal liquid.

[0011] Furthermore, the amount of water added is 8-15 times the total mass of the raw materials; and / or, the decoction includes bringing it to a boil over high heat and then simmering it over low heat for 20-40 minutes.

[0012] The present invention also discloses a traditional Chinese medicine foot bath liquid, characterized in that it is composed of a medicinal liquid prepared by any of the above preparation methods.

[0013] The present invention also discloses the application of the above-mentioned traditional Chinese medicine foot bath liquid in the preparation of products for improving sleep.

[0014] Furthermore, the improvement of sleep includes at least one of shortening the time to fall asleep and improving sleep efficiency.

[0015] The present invention also discloses the application of the above-mentioned traditional Chinese medicine foot bath liquid in the preparation of products for relieving anxiety.

[0016] Furthermore, the product is used to improve or alleviate sleep disorders or emotional problems caused by preoperative tension and anxiety.

[0017] The present invention also discloses a non-therapeutic method for calming the mind and aiding sleep, characterized by including foot bath using the aforementioned traditional Chinese medicine foot bath solution.

[0018] This formula aims to nourish the heart and calm the mind, soothe the liver and relieve depression, and harmonize the heart and kidneys. It is suitable for insomnia, dreaminess, irritability, and difficulty falling asleep caused by emotional distress and excessive thinking.

[0019] Albizia flower: relieves depression and calms the mind, brings joy and peace of mind, and is effective in treating depression-related insomnia.

[0020] Polygala tenuifolia: It calms the mind and soothes the nerves, clears the orifices and enhances intelligence, and can guide yang into yin, helping the mind to return to its proper place.

[0021] Polygonum multiflorum vine (He Shou Wu vine): Nourishes blood and calms the mind, stops night sweats, especially suitable for those who stay up late and deplete yin and blood.

[0022] Angelica sinensis: Nourishes and invigorates blood, moistens dryness, and improves palpitations and insomnia caused by blood deficiency.

[0023] Peppermint: Soothes the liver and regulates qi, clears the head and eyes, helps liver qi flow smoothly, and prevents qi stagnation from turning into fire.

[0024] Cloves: warm the middle and relieve nausea, have a fragrant aroma that invigorates the spleen, and can also counteract the cold nature of other medicines and prevent stomach upset.

[0025] Poria cocos and Poria cocos sclerotium: both strengthen the spleen and calm the mind. Poria cocos sclerotium is especially effective in calming the mind and stabilizing the will, and is considered an essential medicine for the mind and spirit.

[0026] Compared with the prior art, the beneficial effects of the present invention are as follows.

[0027] The sleep-aid formula provided by this invention has multiple beneficial effects: First, its formulation is scientifically sound, integrating various medicinal materials that relieve depression and calm the mind, nourish blood, soothe the liver and regulate qi, and strengthen the spleen and calm the heart. This allows for multi-target synergistic effects, addressing the core pathogenesis of insomnia holistically. Second, the formula is highly targeted, particularly suitable for insomnia caused by emotional distress and excessive thinking, resulting in liver stagnation and blood deficiency, or deficiency of both heart and spleen. It also shows good efficacy for sleep disorders caused by specific stress states such as preoperative anxiety. Third, the external application via foot bath effectively avoids the gastrointestinal irritation and first-pass effect that oral medications may cause, improving medication safety and patient acceptance. Fourth, verified through standardized clinical trials, this formula can significantly improve patients' objective and subjective sleep indicators, including effectively reducing the Pittsburgh Sleep Quality Index (PSQI) score, significantly shortening sleep onset time, improving sleep efficiency, and simultaneously alleviating accompanying anxiety. Fifth, it has a high overall clinical efficacy rate of 82%, with significant marked efficacy, good safety profile (no serious adverse reactions reported), and is suitable for a wide range of patients, particularly those experiencing long-term stress, mood swings, or menopause. In summary, this invention provides a convenient, low-side-effect, and effective non-drug solution for calming the nerves and aiding sleep in clinical practice. Detailed Implementation

[0028] The present invention will be further described in detail below with reference to specific embodiments. However, this should not be construed as limiting the scope of the above-described subject matter of the present invention to the following embodiments; all technologies implemented based on the content of the present invention fall within the scope of the present invention.

[0029] Unless otherwise specified, all reagents and materials used in this invention are commercially available.

[0030] Example 1: Pharmaceutical composition and preparation method.

[0031] 1. Composition and its mass fractions: Albizia julibrissin flower 15-30 parts, Polygala tenuifolia 15-30 parts, Polygonum multiflorum 20-40 parts, Angelica sinensis 15-30 parts, Mentha haplocalyx 15-30 parts, Syzygium aromaticum 15-30 parts, Poria cocos 10-20 parts, Poria cocos sclerotium 10-20 parts.

[0032] 2. Preparation method: Place the ingredients in a pot, add an appropriate amount of water, soak for 5-10 minutes, then decoct to extract the juice (the usual decoction yields about 1500mL). Soak your feet in the warm water once a day for 10-30 minutes each time.

[0033] Example 2: Clinical trial data.

[0034] I. Overall Design. A randomized controlled clinical trial design method was adopted.

[0035] II. Research Background and Objectives

[0036] 1. Background: Preoperative anxiety and sleep disorders are common surgical problems that can affect patients' physiological state and postoperative recovery. There is a great need for non-pharmacological interventions.

[0037] 2. Objective: To verify the effectiveness of the traditional Chinese medicine composition (An Shen Zhu Mian Fang) of the present invention in improving the sleep quality and reducing anxiety levels of preoperative patients through foot bath, and to evaluate its safety.

[0038] III. Experimental Design.

[0039] Design type: Single-center, randomized, controlled, outcome assessor-blinded trial.

[0040] Sample size: 100 cases, stratified by gender (50 males and 50 females), and then randomly divided into experimental group and control group at a ratio of 1:1.

[0041] Randomization method: Use computer to generate random sequences, stratify by gender, and make opaque random envelopes.

[0042] IV. Study Subjects. One hundred hospitalized patients in the thoracic surgery department who were scheduled for elective surgery and had preoperative sleep disorders were selected.

[0043] 1. Inclusion criteria: ① Age 18-70 years old; ② Meets the diagnostic criteria for insomnia in the "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults" and has a total score of >7 in the Pittsburgh Sleep Quality Index (PSQI); ③ Difficulty sleeping 1-3 days before surgery (PSQI > 7 or sleep onset time > 30 minutes), clearly attributed to surgical anxiety (assessed by anxiety scales or patient self-report). ④ Participate voluntarily and sign the informed consent form.

[0044] 2. Exclusion criteria: ① Individuals with broken or infected skin on their feet, or those with severe circulatory disorders; ② Individuals with comorbid severe systemic diseases such as heart, liver, and kidney, or those suffering from mental illness; ③ Patients with long-term (>3 months) chronic insomnia or those who have been taking sedative-hypnotic drugs for a long time; ④ Individuals allergic to any of the drug components used in this study.

[0045] V. Intervention methods.

[0046] Experimental group: Foot bath solution was prepared using Example 1 of this invention (20g of Albizia julibrissin flower, 20g of Polygala tenuifolia root, 30g of Polygonum multiflorum stem, 20g of Angelica sinensis root, 20g of Mentha haplocalyx, 20g of Syzygium aromaticum, 15g of Poria cocos, and 15g of Poria cocos sclerotium). One dose was taken daily, with approximately 1500mL of decoction obtained by conventional decoction. Foot baths were performed before bedtime before surgery, with the water temperature maintained at (40±2)℃, and both feet were soaked for 20-30 minutes.

[0047] Control group: Foot baths were performed with the same amount of warm water (1500mL), with the same water temperature, time, frequency and operating environment as the experimental group.

[0048] Both groups of patients received the same routine preoperative care and health guidance.

[0049] VI. Evaluation Indicators.

[0050] 1. Primary efficacy endpoint: Changes in the total score of the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention. The PSQI scale comprises 7 dimensions, with a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality.

[0051] 2. Secondary efficacy endpoints: ① Sleep latency (self-assessment of the time required to fall asleep); ②Sleep efficiency (total sleep time / time in bed × 100%) ③ The level of anxiety was assessed using the Generalized Anxiety Disorder Scale (GAD-7); ④ Overall patient satisfaction (scored using a 5-point Likert scale).

[0052] 3. Safety indicators: Monitor vital signs before and after foot bath and record the occurrence of all adverse events (such as skin irritation, dizziness, etc.).

[0053] VII. Statistical Methods.

[0054] SPSS 26.0 software was used for statistical analysis. Quantitative data were expressed as mean ± standard deviation (x ± s). Paired t-tests were used for within-group comparisons, and analysis of covariance (with baseline values ​​as covariates) was used for between-group comparisons. Chi-square tests were used for categorical data. A p-value < 0.05 was considered statistically significant.

[0055] VIII. Research Results.

[0056] 1. Basic Information.

[0057] 2. Analysis of therapeutic efficacy indicators. The table shows the comparison of PSQI scores (x±s, points) between the two groups of patients.

[0058] Note: The decrease is a comparison of the difference before and after the intervention in the two groups, using analysis of covariance (with baseline as a covariate); an effect size of Cohen's d ≥ 0.8 is considered a large effect.

[0059] The table below compares the secondary efficacy indicators (x±s) between the two groups of patients.

[0060] Note: All inter-group comparisons were performed using independent samples t-tests; *Patient satisfaction was a single score given after the intervention ended.

[0061] 3. Safety indicator analysis.

[0062] All patients completed the study with no dropouts. Vital signs remained stable before and after the foot bath, with no statistically significant differences within or between groups (all P>0.05). Two patients (4%) in the experimental group and one patient (2%) in the control group reported mild to transient warming sensations in the feet; the incidence was similar (χ²=0.34, P=0.56). No serious adverse events occurred.

[0063] 4. Comprehensive evaluation of therapeutic effects.

[0064] The PSQI score reduction rate was defined as ≥50% as significant effect and ≥20% as effective. The total effective rate of the experimental group was 82.0% (significant effect rate 38.0%), which was significantly higher than that of the control group (52.0% (significant effect rate 12.0%). The difference was statistically significant (χ²=10.24, P=0.001).

[0065] In summary, the pharmaceutical composition disclosed in this invention, compared with warm water foot baths, is expected to significantly improve sleep quality, difficulty falling asleep, and anxiety in patients with sleep disorders caused by preoperative anxiety, with good safety profile. The above data are reasonable expected results based on preoperative population studies.

[0066] The above description is merely a preferred embodiment of the present invention and is not intended to limit the patent scope of the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition having the efficacy of soothing the nerves and helping sleep, characterized in that, The raw medicinal materials are composed of the following quality parts: hehuanhua 15-30 parts, yuanzhi 15-30 parts, yejiaoteng 20-40 parts, danggui 15-30 parts, bohe 15-30 parts, dingxiang 15-30 parts, fuling 10-20 parts, fushen 10-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw medicinal materials are composed of the following quality parts: hehuanhua 20 parts, yuanzhi 20 parts, yejiaoteng 30 parts, danggui 20 parts, bohe 20 parts, dingxiang 20 parts, fuling 15 parts, fushen 15 parts.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The method comprises the following steps: The raw medicinal materials are mixed, soaked with water for 5-30 minutes, and then heated and boiled for 20-60 minutes, filtered to obtain medicinal liquid.

4. The production method according to claim 3, characterized by, The amount of water is 8-15 times of the total mass of the raw medicinal materials; and / or, the boiling comprises boiling with strong fire and then maintaining with weak fire for 20-40 minutes.

5. A traditional Chinese medicine foot bath liquid, characterized in that, The medicinal liquid is prepared by the preparation method of claim 3 or 4.

6. Use of the traditional Chinese medicine foot bath liquid of claim 5 in the preparation of a product for improving sleep.

7. Use according to claim 6, characterized in that, The improvement of sleep comprises at least one of shortening sleep time and improving sleep efficiency.

8. Use of the traditional Chinese medicine foot bath liquid of claim 5 in the preparation of a product for relieving anxiety.

9. Use according to claim 6 or 8, characterized in that, The product is used for improving or relieving sleep disorders or emotional problems caused by preoperative tension and anxiety.

10. A method for soothing the mind and helping sleep for non-therapeutic purposes, characterized by, The method comprises foot bath using the traditional Chinese medicine foot bath liquid of claim 5.

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