Traditional Chinese medicine composition for improving sleep, pillow and preparation method thereof

Abstract

The present invention discloses a Chinese medicine composition for improving sleep, a pillow, and a preparation method thereof. The Chinese medicine composition is composed of the following raw materials in parts by weight: 75 to 150 parts of Acorus calamus, 75 to 150 parts of Polygala tenuifolia, 75 to 150 parts of Polygonum multiflorum, 10 to 50 parts of Nardostachys serrata, 50 to 100 parts of Dragon Bone, and 50 to 100 parts of Ostreae confusa. The Chinese medicine composition of the present invention is based on the causes and pathogenesis of insomnia and is dialectically combined with the mechanism of action of nourishing the heart and calming the mind and invigorating the spleen through aromatic properties. It can effectively prevent, improve, and / or treat insomnia, greatly improves user compliance and enhances user comfort, and does not cause toxic side effects or dependence, thus having great clinical significance.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and more specifically, the present invention relates to a traditional Chinese medicine composition for improving sleep, a pillow for improving sleep and a preparation method thereof. Background Art

[0002] Sleep disorders refer to a syndrome characterized by impaired sleep initiation and maintenance, resulting in sleep quality failing to meet individual physiological needs and significantly impacting daytime activities. Currently, sleep disorders not only affect patients' daily work efficiency and quality of life, but can also lead to emotional symptoms such as low mood, depression, difficulty concentrating, anxiety, and irritability. If sleep quality fails to improve significantly over time, it can even lead to cardiovascular and cerebrovascular diseases. Improving sleep has become a pressing issue for many people.

[0003] Traditional Chinese Medicine theory states that the heart governs blood and serves as its home. Heart Qi propels blood through the veins, providing the driving force behind its continuous circulation. Heart blood deficiency, resulting in disharmony of Qi and blood, leads to a lack of nourishment for the mind and heart, leading to insomnia. The heart governs consciousness and is the home of the spirit. The heart is the master of the five internal organs and the master of the spirit, overseeing all mental and cognitive activities. A stable heart Qi stabilizes the internal organs. Abnormal heart function governing consciousness leads to sleep disorders. Balanced heart Yin and Yang, Qi, and blood allow for normal sleep and wakefulness. Insomnia stems from insufficient heart Yin, excessive heart Yang, and restless mind. "Insomnia without evil in the body must be due to a deficiency of Ying Qi. Ying Qi governs blood, and blood deficiency prevents nourishment for the heart. A weak heart causes restlessness in the mind." This can be caused by insufficient endowment, a weak heart, timidity, and a predominant Yin constitution. Excessive sexual activity can also deplete kidney Yin, preventing it from reaching the heart. This imbalance of water and fire leads to hyperactivity of heart Fire. Alternatively, liver and kidney Yin deficiency can lead to hyperactivity of liver Yang, resulting in excessive fire and restlessness, leading to a disharmony between the heart and kidney, and a restless mind. As stated in "Xizhu: The Origin of Miscellaneous Diseases: Insomnia and Excessive Sleeping," "There are those who are fearful and timid, easily startled by things, have many ominous dreams, and suffer from restlessness and insomnia." As stated in "Insomnia" in "The Complete Works of Jingyue": "When the true yin, essence, and blood are deficient, yin and yang are not in harmony, and the spirit is restless." Some people suffer from insomnia or poor sleep due to a weak heart, fear, sudden shock, and restlessness. The spleen and stomach, located in the middle burner, are the source of qi and blood production and transformation. Therefore, the spleen is called the foundation of the acquired constitution. The spleen is responsible for ascending the clear, regulating blood circulation, transforming qi and blood, and ascending and descending qi. Abnormal spleen and stomach function, resulting in impaired digestion and absorption, insufficient qi and blood production, abnormal blood circulation, and imbalanced water metabolism, can lead to an inability to transport and transform qi and blood. This leads to a lack of support for the spirit and nourishment for the heart, resulting in insomnia. "Suwen: The Theory of Reverse Tiao" states, "If the stomach is not in harmony, one will be restless." Spleen and stomach disharmony leads to dysfunctional ascending and descending functions in the middle burner, preventing turbid qi from descending, which disturbs the mind and causes insomnia. An irregular diet can damage the spleen and stomach, causing stagnation and congestion in the heart, disrupting stomach qi and causing yang qi to rise externally, leading to restless sleep. Alternatively, overeating rich, sweet foods can generate phlegm and heat, disturbing the mind and causing insomnia. Alternatively, an irregular diet can damage the spleen and stomach, leading to poor spleen function, insufficient qi and blood production, insufficient heart blood, and a lack of nourishment for the heart, causing insomnia. Therefore, insomnia stems from emotional and dietary damage, illness, advanced age, insufficient endowment, and timidity, all of which lead to a lack of nourishment or restlessness.

[0004] Currently, Western medicine often uses sedatives such as alprazolam, estazolam, and eszopiclone to treat this condition. While these medications are effective for some patients, they often come with significant side effects and can easily lead to relapses after discontinuation. Traditional Chinese medicine (TCM) treatments for this condition are often long, and traditional acupuncture and Chinese medicine methods often have poor patient compliance.

[0005] Pillows are essential sleep aids, and their comfort impacts sleep quality and overall well-being. Pillow cores are the fillings within pillows, and there are many different types of fillings, depending on personal preference. The use of medication to aid sleep has a long history, and Traditional Chinese Medicine (TCM) has been used for both oral and topical applications.

[0006] A key external treatment method is the use of medicated pillows to aid sleep. The head and neck are where the twelve meridians and the Chong, Ren, and Du meridians converge. Medicated pillows, through prolonged contact with the skin and tissue of the neck and shoulders, stimulate specific acupoints, unblocking the meridians and thus exerting their therapeutic effects. They also embody the traditional Chinese medicine practice of "healing through fragrance." Medicated vapors enter the body through breathing, penetrate the skin through various acupoints on the head, and penetrate deep into the internal organs, slowly and continuously exerting their effects, while balancing efficacy and convenience.

[0007] Existing medicated pillows are mostly filled with herbs or gluten. Some also use traditional Chinese medicine compositions as fillers, but the formulas are relatively complex and lack rigor, resulting in unsatisfactory sleep-inducing effects. Therefore, it is particularly important to select a traditional Chinese medicine composition with a simple formula and ideal sleep-inducing effects for medicated pillows. Summary of the Invention

[0008] Based on this, one of the purposes of the present invention is to provide a Chinese medicine composition for improving sleep, which has a simple formula, has a good tranquilizing effect, and helps to improve sleep.

[0009] The specific technical solutions for achieving the above-mentioned invention objectives are as follows:

[0010] A traditional Chinese medicine composition for improving sleep is composed of the following raw materials in parts by weight: 75-150 parts of Acorus calamus, 75-150 parts of Polygala tenuifolia, 75-150 parts of Polygonum multiflorum, 10-50 parts of Nardostachys chinensis, 50-100 parts of Dragon Bone, and 50-100 parts of Ostreae confusa.

[0011] In some embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 100 to 130 parts of Acorus calamus, 100 to 130 parts of Polygala tenuifolia, 75 to 130 parts of Polygonum multiflorum, 20 to 40 parts of Nardostachys grandiflora, 50 to 75 parts of Dragon Bone, and 50 to 75 parts of Ostreae conchae.

[0012] In some embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 100 to 105 parts of Acorus calamus, 100 to 105 parts of Polygala tenuifolia, 95 to 100 parts of Polygonum multiflorum, 25 to 30 parts of Nardostachys grandiflora, 60 to 65 parts of Dragon Bone, and 55 to 60 parts of Ostreae conchae.

[0013] In some embodiments, the keel is a raw keel, and the oyster is a raw oyster.

[0014] The invention also provides a pillow for improving sleep.

[0015] The specific technical solutions for achieving the above-mentioned invention objectives are as follows:

[0016] A pillow for improving sleep, comprising a pillowcase and a pillow core, and also comprising the above-mentioned traditional Chinese medicine composition for improving sleep.

[0017] The present invention also provides a method for preparing the pillow for improving sleep.

[0018] The specific technical solutions for achieving the above-mentioned invention objectives are as follows:

[0019] A method for preparing a pillow for improving sleep comprises the following steps:

[0020] (1) uniformly mix the raw materials of the Chinese medicine composition in parts by weight and grind them into powder;

[0021] (2) Pour the powder from step (1) into the inner bag and seal it;

[0022] (3) Place the inner bag described in step (2) in the pillowcase and place it on the pillow core.

[0023] In some embodiments, the particle size of the powder in step (1) is 3 mm to 5 mm.

[0024] In some embodiments, the inner bag in step (2) is made of breathable gauze with a density of 50.

[0025] In some embodiments, the amount of powder loaded into the inner bag in step (2) is 335 g to 700 g.

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

[0027] 1. The present invention starts from the cause and pathogenesis of insomnia, and dialectically combines the action mechanisms of nourishing the heart and calming the mind and aromatically invigorating the spleen, thereby obtaining a traditional Chinese medicine composition that can prevent, improve and treat insomnia. The prescription of the traditional Chinese medicine composition includes Acorus gramineus, Polygala tenuifolia, Polygonum multiflorum, raw dragon bone, raw oyster and Nardostachys grandiflora. In the prescription, Polygala tenuifolia is bitter and warm but not dry, aromatic and clear, pungent and warm, can tranquilize the mind and calm the mind, dissipate depression and resolve phlegm, can activate kidney qi to ascend to the heart orifices, and can open up kidney qi to the heart; Acorus gramineus is pungent and disperses the liver and is fragrant and soothes the spleen, can resolve phlegm and reduce turbidity, unclog the orifices, and has a calming and tranquilizing effect. Together with Polygala tenuifolia, it calms the mind and nourishes the heart, communicates up and down, and works together as the main medicine; Polygonum multiflorum, also known as Shouwu vine, has a soft and dense texture, a sweet taste that enters the heart, can nourish the heart and calm the mind, and is good at treating insomnia. Insomnia and dreaminess; Dragon bone is sweet, flat and astringent in nature, enters the heart, liver and kidney meridians, can restrain floating Yang Qi, and has the functions of nourishing the kidney and calming the soul, calming the liver and suppressing Yang; oyster is the counterpart of dragon bone, and the two medicines work together to calm down and suppress Yang; sweet pinellia is an aromatic substance, good at entering the spleen and stomach meridians, and because of its dispersing nature, it has the functions of dispelling turbidity and removing filth, and dispersing and moving the orifices, thereby stimulating its Qi to circulate throughout the body. Under the action of aromatic substances, the trapped spleen can rise again with clear Yang, and the spleen can circulate freely, that is, it can "awaken the spleen" and thus "calm the mind". Dragon bone can be used to reduce thunder and fire, calm the liver and suppress Yang, and replenish essence and nourish marrow, and work together with oyster to calm down and suppress Yang; the 6 herbs in the Chinese medicine composition of the present invention work together to resolve phlegm and wake up the spleen, wake up the spleen and relieve depression, nourish the heart and calm the mind, and can significantly improve the patient's sleep condition.

[0028] 2. The inventors of the present invention have conducted extensive exploration on the dosage of various raw materials of the traditional Chinese medicine composition and obtained the optimal formula, which can not only adjust the qi and blood functions of the human organs, nourish the heart and calm the mind, and invigorate the spleen, but also greatly improve the user's compliance and enhance the comfort of use. There will be no odor of a single ingredient or the texture will be too rough. It effectively improves the patient's sleep state and does not cause toxic side effects and dependence. It has great clinical significance.

[0029] 3. The sleep-improving pillow of the present invention contains a traditional Chinese medicine composition for improving sleep. The pillow is in contact with the skin tissue of the neck and shoulders for a long time, and the medicinal gas penetrates into the skin through various acupuncture points on the head and penetrates into the internal organs. The medicinal gas enters the body through breathing, thereby achieving a slow and continuous effect of the medicine, preventing, improving, and / or treating insomnia, and taking into account both efficacy and convenience. DETAILED DESCRIPTION

[0030] To facilitate understanding of the present invention, the present invention will be described more fully below. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the present disclosure more thorough and comprehensive.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification are for the purpose of describing specific embodiments only and are not intended to limit the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0032] The present invention will be further described in detail below with reference to specific examples. The equipment used in the following examples, unless otherwise specified, are all commonly used equipment in the art, and the methods used, unless otherwise specified, are all commonly used methods in the art.

[0033] Example 1 A Chinese medicine composition and pillow for improving sleep

[0034] The Chinese medicine composition for improving sleep in this embodiment is composed of the following raw materials by weight:

[0035] 100g of Acorus calamus, 100g of Polygala tenuifolia, 100g of Polygonum multiflorum, 30g of Nardostachys grandiflora, 60g of raw dragon bone, and 60g of raw oyster.

[0036] The sleep-improving pillow of this embodiment is prepared as follows:

[0037] (1) Mix the raw materials uniformly according to the above weight, pour them into a high-speed grinder and grind them into 3mm to 5mm coarse powder.

[0038] (2) Pour all the ground coarse powder into an inner bag made of 50-count breathable gauze and seal it.

[0039] (3) Place the pillow core in the pillowcase, and then place the inner bag on the pillow core to obtain the pillow for improving sleep of this embodiment.

[0040] Example 2 A Chinese medicine composition and pillow for improving sleep

[0041] The Chinese medicine composition for improving sleep in this embodiment is composed of the following raw materials by weight:

[0042] 100g of Acorus calamus, 100g of Polygala tenuifolia, 150g of Polygonum multiflorum, 30g of Nardostachys grandiflora, 60g of raw dragon bone, and 60g of raw oyster.

[0043] The preparation method of the sleep-improving pillow of this embodiment is the same as that of Example 1.

[0044] Example 3 A Chinese medicine composition and pillow for improving sleep

[0045] The Chinese medicine composition for improving sleep in this embodiment is composed of the following raw materials by weight:

[0046] 100g of Acorus calamus, 100g of Polygala tenuifolia, 100g of Polygonum multiflorum, 50g of Nardostachys grandiflora, 100g of raw dragon bone, and 100g of raw oyster.

[0047] The preparation method of the sleep-improving pillow of this embodiment is the same as that of Example 1.

[0048] Comparative Example 1

[0049] The Chinese medicine composition of this comparative example is composed of the following raw materials by weight:

[0050] 100g of Polygonum multiflorum, 30g of Nardostachys grandiflora, 60g of raw dragon bone, and 60g of raw oyster.

[0051] The pillow of Comparative Example 1 has an inner bag containing the above-mentioned Chinese medicine composition. The preparation method is similar to that of Example 1.

[0052] Comparative Example 2

[0053] The Chinese medicine composition of this comparative example is composed of the following raw materials by weight:

[0054] 100g of Acorus calamus, 100g of Polygala tenuifolia, 30g of Nardostachys grandiflora, 60g of raw dragon bone, and 60g of raw oyster.

[0055] The pillow of Comparative Example 2 has an inner bag containing the above-mentioned Chinese medicine composition. The preparation method is similar to that of Example 1.

[0056] Comparative Example 3

[0057] The Chinese medicine composition of this comparative example is composed of the following raw materials by weight:

[0058] 100g of Acorus calamus, 100g of Polygala tenuifolia, 100g of Polygonum multiflorum, 60g of raw dragon bone, and 60g of raw oyster.

[0059] The pillow of Comparative Example 3 has an inner bag containing the above-mentioned Chinese medicine composition. The preparation method is similar to that of Example 1.

[0060] Comparative Example 4

[0061] The Chinese medicine composition of this comparative example is composed of the following raw materials in parts by weight:

[0062] 100g of Pinellia ternata, 100g of Magnolia officinalis, 100g of Polygonum multiflorum, 30g of Nardostachys grandiflora, 60g of raw dragon bone, and 60g of raw oyster.

[0063] The pillow of Comparative Example 4 has an inner bag containing the above-mentioned Chinese medicine composition. The preparation method is similar to that of Example 1.

[0064] Comparative Example 5

[0065] This comparative example is an ordinary pillow, that is, an ordinary pillow core is built into the pillowcase.

[0066] Study on the effect of the pillows of Examples 1 to 3 and Comparative Examples 1 to 5 on improving the sleep quality of insomnia patients

[0067] This experiment studied the effects of the pillows of Examples 1 to 3 and Comparative Examples 1 to 5 on improving the sleep quality of insomniacs.

[0068] 1. Clinical Data

[0069] 1. Source of cases

[0070] All patients were hospitalized at the Affiliated Brain Hospital of Guangzhou Medical University. They voluntarily participated in this study and signed informed consent. A total of 200 patients were randomly divided into a control group and a treatment group according to the order of admission.

[0071] 2. Disease diagnostic criteria

[0072] The diagnostic criteria for non-organic sleep disorders were formulated with reference to the 10th edition of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).

[0073] 3. Case inclusion criteria

[0074] Those who meet the disease diagnostic criteria, have no abnormal EEG examination, no history of physical illness, and have signed the informed consent form.

[0075] 4. Case exclusion criteria

[0076] (1) Does not meet the diagnostic criteria

[0077] (2) Patients with serious primary diseases of the heart, brain, lung, kidney or hematopoietic system

[0078] (3) Pregnant or lactating women

[0079] (4) Alcoholics or sedative abusers

[0080] (5) Those who refused to cooperate or discontinued treatment were not included in the scope of this study.

[0081] 2. Treatment Methods

[0082] 1. Experimental Grouping

[0083] The patients who met the inclusion criteria were divided into the following groups according to the principle of randomization and control:

[0084] Treatment Group 1 (using the pillow of Example 1)

[0085] Treatment Group 2 (using the pillow of Example 2)

[0086] Treatment Group 3 (using the pillow of Example 3)

[0087] Control group 1 (using the pillow of comparative example 1)

[0088] Control group 2 (using the pillow of comparative example 2)

[0089] Control group 3 (using the pillow of comparative example 3)

[0090] Control group 4 (using the pillow of comparative example 4)

[0091] Control group 5 (using the ordinary pillow of comparative example 5)

[0092] There were 25 cases in each group, for a total of 200 cases.

[0093] Before bedtime (21:00), patients used the pillows provided by the nurses, Examples 1-3, and Control Groups 1-4, as their headrests instead of their regular pillows. Control Group 5 used a regular pillow. The pillows were used for ≥8 hours per day and night. A course of treatment consisted of 7 days, with two courses of treatment being used consecutively.

[0094] The control group and the treatment group were given conventional sedatives every night as basic treatment. 2 There was no significant difference in age, gender and disease course between the two groups after statistical processing (X 2 There was no significant difference between the two samples.

[0095] 2. Observation indicators

[0096] (1) Evaluation of therapeutic efficacy

[0097] The sleep quality of the subjects was assessed using the Athens Insomnia Scale (AIS), and the effects of the tranquilizing pillows of Examples 1 to 3 and Comparative Examples 1 to 5 on their sleep quality were recorded. The total score ranged from 0 to 24, with higher scores indicating more severe insomnia.

[0098] (2) Safety evaluation

[0099] It includes blood routine, biochemistry (liver function, kidney function, electrolytes, myocardial enzymes, blood lipids), electrocardiogram, chest X-ray, B-ultrasound and other examinations; the side effects of insomnia subjects are assessed using the side effect scale.

[0100] 3. Observation time

[0101] Evaluation was conducted once at the beginning of treatment and once after 2 weeks of treatment.

[0102] 4. Efficacy evaluation criteria

[0103] (1) Clinical cure: No significant insomnia symptoms at the end of the treatment.

[0104] (2) Markedly effective: The score decreased by more than 50% after treatment.

[0105] (3) Effective: The score decreased by 20% to 50% after treatment.

[0106] (4) Ineffective: The score decreased by less than 20% after treatment.

[0107] The total effective rate was calculated by taking the sum of clinical cure, marked effect and effectiveness as the effective value.

[0108] Statistical Analysis: SPSS for Windows software was used to analyze the efficacy statistics of each group of insomnia subjects before and after treatment. The rank sum ratio method was used to conduct a comprehensive evaluation of the statistical data of each group.

[0109] 3. Experimental Results

[0110] 1. Efficacy evaluation

[0111] After two courses of treatment, the gender, first AIS score and last AIS score of each group are shown in Tables 1 to 8, respectively.

[0112] Table 1 AIS scores and reduction statistics of treatment group 1

[0113]

[0114]

[0115] Table 2 AIS scores and reduction statistics of treatment group 2

[0116]

[0117]

[0118] Table 3 AIS scores and reduction statistics of treatment group 3

[0119]

[0120]

[0121] Table 4 AIS scores and reduction statistics of control group 1

[0122]

[0123]

[0124] Table 5 AIS scores and reduction statistics of control group 2

[0125]

[0126]

[0127] Table 6 AIS scores and reduction statistics of control group 3

[0128]

[0129]

[0130] Table 7 AIS scores and reduction statistics of control group 4

[0131]

[0132]

[0133] Table 8 AIS scores and reduction statistics of control group 5

[0134] serial number gender First AIS score Last AIS score Decrease 1 male 12 11 8％ 2 female 13 13 0％ 3 male 9 7 22％ 4 female 17 15 12％ 5 male 15 13 13％ 6 female 15 13 13％ 7 male 8 7 13％ 8 female 7 6 14％ 9 female 8 8 0％ 10 male 9 8 11％ 11 male 18 15 17％ 12 female 14 14 0％ 13 male 15 13 13％ 14 female 10 9 10％ 15 male 10 9 10％ 16 female 16 9 44％ 17 male 9 8 11％ 18 female 7 4 43％ 19 female 11 9 18％ 20 male 12 12 0％ 21 male 14 12 14％ 22 male 11 10 9％ 23 female 17 14 18％ 24 male 6 5 17％ 25 male 15 13 13％

[0135] The efficacy of the insomnia subjects in each treatment group and control group in Tables 1 to 8 was statistically analyzed, and the results are shown in Table 9.

[0136] Table 9 Statistics of the efficacy of each group of insomnia subjects before and after treatment

[0137]

[0138] The rank sum ratio method was used to further analyze the efficacy statistical results of each group in Table 9. The following steps were included:

[0139] The first step is to calculate the RSR values of each item in Table 9. The results are shown in Table 10.

[0140] Table 10 RSR value calculation results

[0141]

[0142] In the second step, after the RSR value is calculated, the RSR distribution value is first obtained by combining the RSR value, and the frequency, cumulative frequency and average rank value of each distribution value are obtained; according to the average rank / n value, the probability distribution Probit value is calculated; the results are shown in Table 11.

[0143] Table 11 RSR distribution value and Probit value results

[0144]

[0145]

[0146] The third step is to perform linear regression using the RSR distribution value as the independent variable and the Probit value as the dependent variable; see Table 12.

[0147] Table 12 Regression model analysis

[0148]

[0149] The fourth step is to calculate the percentile critical value, probit critical value, and RSR critical value based on the regression model, as shown in Table 13.

[0150] Table 13 Critical value table for grading

[0151] Grade Percentile critical value Probit critical value RSR critical value (fitted value) 1st gear <15.866 <4 <0.341 Gear 2 15.866～ 4～ 0.341～ Gear 3 84.134～ 6～ 0.700～

[0152] By comparing the RSR fitting value with the RSR critical (fitting value) in Table 13, the grading level is obtained, as shown in Table 14.

[0153] Table 14 Ranking results of grade levels

[0154]

[0155]

[0156] The variance consistency test was performed on the best grading results, and the test result P≤0.1, that is, the differences between each grade were statistically significant.

[0157] Assuming total effective rate and clinical cure rate as high-quality indicators, and marked effective rate and efficacy rate as low-quality indicators, we calculated the RSR value, calculated the RSR distribution, constructed the fitting model, and obtained the tier ranking critical values and tier ranking results, as shown in Tables 10 to 14. In Table 14, higher RSR fitting values, higher RSR rankings, and larger tier level numbers indicate higher levels, that is, better effects.

[0158] As can be seen from the results in Table 14, the RSR fitting values of Examples 1 and 3 are significantly greater than those of Comparative Examples 1-5, and their grading levels are also higher than those of Comparative Examples 1-5, indicating that the pillows of Examples 1 and 3 have significantly improved and treated insomnia compared to the pillows of Comparative Examples 1-4. Although Example 2 has the same grading level of 2 as Comparative Examples 1-4, its RSR fitting value is significantly higher than that of Comparative Examples 1-4, statistically indicating that the pillow of Example 2 also has significantly improved and treated insomnia compared to the pillows of Comparative Examples 1-4. Based on Tables 9 and 14, the six medicinal ingredients in the traditional Chinese medicine composition of the present invention work synergistically to resolve phlegm and invigorate the spleen, invigorate the spleen and relieve depression, and nourish the heart and calm the mind, significantly improving patients' sleep. The traditional Chinese medicine composition and pillow of Example 1 are the most effective.

[0159] 2. Safety evaluation

[0160] During the clinical observation process, the safety observation indicators of each treatment group (including blood routine, liver and kidney function, electrocardiogram, etc.) were all within the normal range, and no adverse toxic and side effects were found in the Chinese medicine composition of the present invention, indicating that the Chinese medicine composition of the present invention and the pillow prepared therefrom are safe and effective.

[0161] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0162] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A Chinese medicine composition for improving sleep, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 100-105 parts of Acorus calamus, 100-105 parts of Polygala tenuifolia, 95-100 parts of Polygonum multiflorum, 25-30 parts of Nardostachys odoratus, 60-65 parts of Dragon's bones, and 55-60 parts of Ostreae conchae.

2. The Chinese medicine composition for improving sleep according to claim 1, characterized in that The dragon bone is a raw dragon bone, and the oyster is a raw oyster.

3. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a pillow for improving sleep.

4. A pillow for improving sleep, characterized in that: The pillow comprises the Chinese medicinal composition for improving sleep according to claim 1 or 2; and the preparation method of the pillow for improving sleep comprises the following steps: (1) Evenly mix the raw materials of the Chinese medicine composition in parts by weight and grind them into powder of 3 mm to 5 mm; (2) Pour the powder from step (1) into the inner bag and seal it; (3) Place the inner bag described in step (2) in the pillowcase and place it on the pillow core.

5. A method for preparing the pillow for improving sleep according to claim 4, characterized in that: The following steps are involved: (1) uniformly mix the raw materials of the Chinese medicine composition in parts by weight and grind them into powder; (2) Pour the powder from step (1) into the inner bag and seal it; (3) Place the inner bag described in step (2) in the pillowcase and place it on the pillow core.

6. The method for preparing a pillow for improving sleep according to claim 5, characterized in that: The particle size of the powder in step (1) is 3 mm to 5 mm.

7. The method for preparing a pillow for improving sleep according to claim 5, characterized in that: The inner bag in step (2) is made of breathable gauze.

8. The method for preparing a pillow for improving sleep according to claim 5, characterized in that: The amount of powder loaded into the inner bag in step (2) is 335g~700g.

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