Traditional Chinese medicine compositions for improving sleep, their preparation methods and applications

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for improving sleep, its preparation method, and its application. To address the technical problem of insomnia caused by damp-heat and phlegm-heat disturbance, this invention provides a traditional Chinese medicine composition for improving sleep, comprising the following components by weight: 10-15 parts of Ziziphus jujuba seed, 10-15 parts of Poria cocos, 5-10 parts of bamboo shavings, 3-10 parts of dried tangerine peel, 3-10 parts of patchouli, and 2-10 parts of licorice root. This invention uses food-medicine homologous substances as raw materials in a rationally formulated combination. Its preparation process is simple, and the resulting traditional Chinese medicine composition has a high content of active ingredients in its extract, exhibiting good antioxidant activity. Furthermore, the compound wine prepared by using this composition as a base liquor also has a significant effect on improving sleep.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for improving sleep, its preparation method, and its application. Background Technology

[0002] Sleep disorders are various functional impairments induced by disruption of the body's normal sleep-wake rhythm, such as insomnia, hypersomnia, and parasomnias, which are typical clinical manifestations. Insomnia is the most common sleep disorder, characterized by difficulty falling asleep, difficulty maintaining sleep, and early awakening. Treatments for insomnia include drug therapy, cognitive behavioral therapy, and dietary supplements. Currently, sedative and hypnotic drugs are often used to indirectly or directly affect neuronal excitability to promote sleep; however, frequent use can lead to drug dependence and may be accompanied by adverse reactions such as palpitations and headaches. Traditional Chinese medicine (TCM) has a long history of treating insomnia and has demonstrated unique efficacy. In TCM, insomnia is called "bumei," and its location is in the heart, related to the liver, gallbladder, spleen, and kidneys. Clinically, there are many types of insomnia, among which damp-heat type is common. Damp-heat disturbs the mind, and prolonged dampness can lead to phlegm, which obstructs the heart. Furthermore, epidemiological surveys show that the prevalence of damp-heat syndrome in the population is as high as 10.55%–12.6%, highlighting the importance of daily heat-clearing, dampness-removing, and phlegm-resolving methods.

[0003] Alcohol is one of the oldest foods and drinks consumed by humankind, and its consumption has been passed down and developed to become an indispensable part of life. Moderate alcohol consumption can promote cardiovascular health and protect lung function, but it can also lead to secondary insomnia, characterized by significantly earlier awakenings and difficulty falling back asleep quickly. From the perspective of Traditional Chinese Medicine, alcohol is considered to have a damp-heat nature; long-term drinking may lead to internal damp-heat, phlegm accumulation, and heat in the stomach and intestines, causing sleep disorders. Modern research shows that alcohol can also stimulate neurotransmitters in the brain involved in sleep-wake cycles, such as dopamine and gamma-aminobutyric acid (GABA), which are substances involved in regulating sleep-wake cycles.

[0004] Regarding the relationship between alcohol consumption and sleep, current focus is often on alcohol poisoning, typically addressed by consuming substances that accelerate alcohol metabolism or alleviate damage before or after drinking. Few products address the damp-heat properties of alcohol, focusing on dispelling dampness and clearing heat to help alleviate sleep disturbances such as premature awakening after drinking. With the industry's shift towards healthier and more scientific practices, health-preserving wines (liqueurs) are emerging as a prominent product. These wines incorporate medicinal and edible ingredients or natural extracts into their production process, offering a greater chance to counteract or reduce the burden of alcohol consumption compared to ordinary wines, and potentially providing multifaceted effects on the body. Furthermore, few publicly available traditional Chinese medicine compositions address insomnia caused by damp-heat or phlegm-heat disturbances. Therefore, developing a traditional Chinese medicine composition that can aid sleep and retain this effect after being incorporated into alcohol, or one that can alleviate the burden on the body caused by alcohol consumption, is of significant importance. Summary of the Invention

[0005] The purpose of this application is to provide a traditional Chinese medicine composition for improving sleep, its preparation method and application, aiming to assist sleep and address the technical problems of the body accompanied by damp-heat and phlegm-heat symptoms.

[0006] To achieve the above-mentioned objectives, the technical solution adopted in this application is as follows:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for improving sleep, which, by weight, comprises the following components:

[0008] Sour jujube seed 10-15 parts, Poria cocos 10-15 parts, bamboo shavings 5-10 parts, dried tangerine peel 3-10 parts, patchouli 3-10 parts, licorice 2-10 parts.

[0009] Preferably, the traditional Chinese medicine composition for improving sleep comprises, by weight, the following components:

[0010] 10 parts of jujube seed, 10 parts of poria cocos, 6 parts of bamboo shavings, 5 parts of dried tangerine peel, 3 parts of patchouli, and 5 parts of licorice.

[0011] More preferably, the traditional Chinese medicine composition further includes 3 parts by weight of gardenia, 6 parts by weight of kudzu root, and 3 parts by weight of honeysuckle.

[0012] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: pulverizing and sieving jujube seed, poria cocos, bamboo shavings, tangerine peel, patchouli, and licorice into powders, mixing them, soaking them in base wine, then ultrasonically crushing them, using the base wine as a solvent for heating and extraction, and centrifuging the extract to obtain the final product.

[0013] In the preparation method, the powder mixture also includes powders prepared by pulverizing and sieving gardenia, kudzu root and honeysuckle respectively.

[0014] The base liquor is at least one of strong-aroma, light-aroma, or sauce-aroma type base liquor. Preferably, the base liquor is a strong-aroma type base liquor.

[0015] The base liquor has an alcohol content of 60-70 v / v%. Preferably, the base liquor has an alcohol content of 70 v / v.

[0016] In the soaking process, the ratio of the mixed medicinal powder to the base liquor is 1:(30-50)g / mL.

[0017] The soaking time is 0.5 to 2 hours.

[0018] The ultrasonic crushing process has a power of 200-400W and a duration of 8-15 minutes.

[0019] The heating extraction is performed 2 to 3 times.

[0020] The heating extraction temperature is 60-70℃, and the extraction time is 0.5-1h per extraction.

[0021] Thirdly, the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for improving sleep quality.

[0022] Fourthly, the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a health-preserving wine for improving sleep quality.

[0023] The health-preserving wine is prepared by freeze-drying the above-mentioned traditional Chinese medicine composition to obtain freeze-dried extract powder, which is then dissolved in a base wine with an alcohol content of 38-60 v / v%. Preferably, the base wine has an alcohol content of 43 v / v%.

[0024] The sleep improvement described in this invention is to improve sleep disorders caused by damp-heat evil and phlegm-heat internal disturbance.

[0025] Beneficial effects:

[0026] (1) This invention provides a traditional Chinese medicine composition, which, by weight, comprises the following components: 10-15 parts of Ziziphus jujuba seed, 10-15 parts of Poria cocos, 5-10 parts of bamboo shavings, 3-10 parts of dried tangerine peel, 3-10 parts of patchouli, and 2-10 parts of licorice. In addition to nourishing the heart and calming the mind, the traditional Chinese medicine composition obtained by this invention also has the effects of clearing heat, removing dampness, and resolving phlegm. It can not only assist sleep but also alleviate the burden caused by long-term alcohol consumption leading to internal damp-heat and phlegm production.

[0027] (2) This invention combines traditional Chinese medicine theory and uses food and medicine homologous substances as raw materials to form a reasonable formula. Its preparation process is simple, and the extract of the obtained traditional Chinese medicine composition has a high content of active ingredients and good antioxidant activity.

[0028] (3) Through experimental comparison, the prepared concentrated extract of traditional Chinese medicine compound can not only synergistically increase the percentage of sleep in mice with subthreshold doses of sodium pentobarbital, but also shorten the sleep latency of suprathreshold doses, prolong sleep time, and thus improve sleep quality.

[0029] (4) The freeze-dried powder of the compound extract of traditional Chinese medicine prepared in this invention, when reconstituted with base wine, also has the effect of improving sleep, which is manifested in delayed wake-up after drinking, and other indicators are also improved. Attached Figure Description

[0030] Figure 1 Example 2: The scavenging ability of the original extract of traditional Chinese medicine compound at different dilution ratios on DPPH free radicals;

[0031] Figure 2 This study examines the scavenging ability of the extracts of traditional Chinese medicine compound at different dilution ratios against ABTS free radicals in Example 2.

[0032] Figure 3The total reducing power of the herbal compound extracts at different dilution ratios in Example 2;

[0033] Figure 4 The effect of different doses of concentrated extract of traditional Chinese medicine compound on the sleep latency of mice is shown in Figure 1.

[0034] Figure 5 The effect of different doses of concentrated extract of traditional Chinese medicine compound on sleep duration in mice is shown in Figure 1.

[0035] Figure 6 The effect of different doses of concentrated extract of traditional Chinese medicine compound on mouse body weight is shown in Figure 1.

[0036] Figure 7 The effect of different doses of the compound Chinese medicine wine on the sleep latency of mice is shown in Figure 2.

[0037] Figure 8 The effect of different doses of the compound Chinese medicine wine on the sleep duration of mice is shown in Figure 2.

[0038] Figure 9 The effect of different doses of the compound Chinese medicine wine on the body weight of mice is shown in Figure 2.

[0039] Figure 10 The effect of different doses of the compound Chinese medicine wine on ALT in mouse liver is shown in Figure 2.

[0040] Figure 11 The effect of different doses of the compound Chinese medicine wine on AST in mouse liver is shown in Figure 2.

[0041] Figure 12 The effect of different doses of the compound Chinese medicine wine on the inflammatory factor IL-1β in the liver of mice is shown in Figure 2.

[0042] Figure 13 The effect of different doses of the compound Chinese medicine wine on the inflammatory factor IL-6 in the liver of mice is shown in Figure 2.

[0043] Figure 14 The figure shows the effect of different doses of the compound Chinese medicine wine on the inflammatory factor TNF-α in the liver of mice in Example 2. Detailed Implementation

[0044] To make the technical problems, solutions, and beneficial effects of this application clearer, the following detailed description is provided in conjunction with the embodiments. Unless otherwise defined, all technical terms used herein have the same meaning as understood by one of ordinary skill in the art.

[0045] The term "traditional Chinese medicine composition" used in this invention is also called "traditional Chinese medicine compound".

[0046] In one embodiment of the present invention, a traditional Chinese medicine composition is provided, which, in addition to nourishing the heart and calming the mind, also has the effects of clearing heat, removing dampness, and resolving phlegm. It can not only help with sleep but also relieve the burden caused by long-term drinking, such as internal damp-heat and phlegm production.

[0047] In a preferred embodiment of the present invention, the provided traditional Chinese medicine composition comprises the following components by weight:

[0048] Sour jujube seed 10-15 parts, Poria cocos 10-15 parts, bamboo shavings 5-10 parts, dried tangerine peel 3-10 parts, patchouli 3-10 parts, licorice 2-10 parts.

[0049] In a preferred embodiment of the present invention, the traditional Chinese medicine composition for improving sleep comprises, by weight, the following components: 10 parts of jujube seed, 10 parts of poria cocos, 6 parts of bamboo shavings, 5 parts of dried tangerine peel, 3 parts of patchouli, and 5 parts of licorice.

[0050] In a more preferred embodiment of the present invention, the traditional Chinese medicine composition further includes 3 parts by weight of gardenia, 6 parts by weight of kudzu root, and 3 parts by weight of honeysuckle.

[0051] In the above-mentioned traditional Chinese medicine compound of the present invention, jujube seed can enter the heart and liver meridians, nourishing heart yin, benefiting liver blood, and calming the mind. Together with poria cocos, it promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind, serving as the principal medicine. Bamboo shavings, tangerine peel and patchouli are used as assistant medicines to dispel dampness and resolve phlegm. Licorice is sweet and mild in nature, enters the heart, lung, spleen and stomach meridians, and can tonify the spleen and replenish qi, clear heat and detoxify, and harmonize the other medicines, serving as the guiding medicine. Gardenia, kudzu root and honeysuckle can further enhance the effects of clearing heat, relieving alcohol and protecting the liver, serving as adjuvant medicines.

[0052] In one embodiment of the present invention, the antioxidant activity of the above-mentioned traditional Chinese medicine compound was verified; at the same time, the effect of the concentrated extract prepared from the above-mentioned traditional Chinese medicine compound on the sleep latency and sleep duration of mice was verified.

[0053] In one embodiment of the present invention, the efficacy of the traditional Chinese medicine compound wine prepared by dissolving the freeze-dried powder of the extract prepared by the above-mentioned traditional Chinese medicine compound into base wine in improving sleep was verified.

[0054] In one embodiment of the present invention, a commonly used combination of medicinal and edible herbs—Poria cocos, licorice root, and jujube seed—was selected, supplemented with ingredients possessing the effects of dispelling dampness, resolving phlegm, clearing heat, and protecting the liver, such as tangerine peel, bamboo shavings, patchouli, gardenia, honeysuckle, and kudzu root, in order to achieve the same sleep-aiding effect when added to alcohol. Studies have shown that alcohol consumption can stimulate neurotransmitters in the brain, such as dopamine and γ-aminobutyric acid (GABA), and long-term alcohol consumption may cause changes in inflammatory factors in the body. The applicant designed experiments and found that the herbal compound of the present invention may regulate insomnia through targets such as IL-6, IL-1β, TNF, AKT1, and IL-10. Possible signaling pathways include neuroactive ligand-receptor interactions, cholinergic synapses, and dopaminergic synapses. This may be one of the factors that allows the herbal compound of the present invention to improve sleep quality even when added to alcohol.

[0055] The following specific embodiments will be provided to explain the solution of the present invention. Those skilled in the art will understand that the following embodiments are for illustrative purposes only and should not be considered as limiting the scope of the invention. Where specific techniques or conditions are not specified in the embodiments, they are performed according to the techniques or conditions described in the literature in the field or according to the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be obtained commercially. The base liquor is a strong-aroma type base liquor.

[0056] Example 1: Preparation of a Traditional Chinese Medicine Compound Extract for Improving Sleep

[0057] Raw material pretreatment: High-quality jujube seed, poria cocos, bamboo shavings, tangerine peel, patchouli, licorice, gardenia, kudzu root, and honeysuckle raw materials are dried at 60℃.

[0058] Raw material crushing: Take the dried raw materials, crush them through a 40-mesh sieve to obtain raw material powders, and store them for later use;

[0059] Soaking: Weigh out 10 parts of jujube seed, 10 parts of poria cocos, 6 parts of bamboo shavings, 5 parts of dried tangerine peel, 3 parts of patchouli, 5 parts of licorice, 3 parts of gardenia, 6 parts of kudzu root, and 3 parts of honeysuckle. Mix the powdered raw materials to obtain a Chinese medicine mixture. Soak the mixture for 1 hour at a ratio of 1 (Chinese medicine mixture amount / g): 30 (70v / v% base wine amount / mL).

[0060] Ultrasonic treatment: The raw material mixture after soaking was subjected to ultrasonic cell disruption treatment, and ultrasonication was performed at 335W ultrasonic power for 11 minutes;

[0061] Heating extraction: After sonication, the mixture was heated at 60°C for 1 hour in a constant temperature water bath. The extract was obtained by centrifugation. The residue was then extracted once by heating with 30 times the amount of 70v / v% base wine as the extraction solvent. The extract was obtained by centrifugation. The two extracts were combined to obtain the original extract of the traditional Chinese medicine compound.

[0062] Example 2: In vitro antioxidant activity of the original extract of traditional Chinese medicine compound

[0063] The in vitro antioxidant activity of the herbal compound extract obtained in Example 1 was characterized, including the following:

[0064] (1) DPPH free radical scavenging ability of the original extract of traditional Chinese medicine compound

[0065] Detection method: Take the original extract of the traditional Chinese medicine compound and dilute it with water 8, 12, 16, 20, and 24 times to obtain the test sample solution; add different concentrations of sample and reagent according to Table 1, mix well, and incubate in the dark for 30 min, then measure the absorbance at 517 nm. Use 2,6-di-tert-butyl-p-cresol (BHT) as a control. Each sample solution is repeated 3 times, and the average value is taken. Preparation of 0.35 mM DPPH solution (weigh a certain amount of 1,1-diphenyl-2-trinitrophenylhydrazine, first prepare a DPPH stock solution with anhydrous ethanol, then take the DPPH stock solution and mix it with an equal volume of ultrapure water to prepare a 0.35 mM DPPH working solution, and then dilute the DPPH working solution with 50% ethanol to make the OD value of the microplate reader 0.7-0.8 before use). BHT is prepared with anhydrous ethanol.

[0066] Table 1. DPPH Determination Methods

[0067] serial number Sample reaction system A1 200 μL of 0.35 mM DPPH solution + 25 μL of sample solution A2 200 μL of 50% ethanol solution + 25 μL of sample solution A3 200 μL of 0.35 mM DPPH solution + 25 μL of ultrapure water

[0068] Calculation of DPPH radical scavenging rate

[0069]

[0070] (2) ABTS free radical scavenging ability of the extract of traditional Chinese medicine compound

[0071] Detection method: Same as (1) dilute the original extract of traditional Chinese medicine compound, add samples and reagents of different concentrations according to Table 2, mix well, react at room temperature in the dark for 6 min, and measure the absorbance at a wavelength of 734 nm. Vitamin C (V C) As a positive control, each sample was repeated three times, and the average value was taken. The ABTS reaction solution was diluted with PBS solution at pH 6.6. The ABTS reaction solution was a 1:1 mixture of 7 mM ABTS solution and 2.4 mM potassium persulfate solution, kept at room temperature in the dark for at least 16 hours, and then diluted with PBS solution at pH 6.6. The absorbance of the solution measured at 734 nm using a microplate reader was 0.7-0.8.

[0072] Table 2 ABTS Measurement Methods

[0073] serial number Sample reaction system A1 200 μL ABTS reaction solution + 20 μL sample solution A0 200 μL of pH 6.6 PBS solution + 20 μL of sample solution A2 200 μL ABTS reaction solution + 20 μL ultrapure water

[0074] ABTS + Calculation of clearance rate

[0075]

[0076] (3) Total reducing power of the original extract of traditional Chinese medicine compound

[0077] Detection method: The iron ion reducing power determination method was used. 100 μL of sample solutions of different concentrations were added to 100 μL of 1% K3Fe(CN)6 solution, mixed thoroughly, and reacted in a 50℃ constant temperature water bath for 20 min. Then, 10% trichloroacetic acid, 300 μL of ultrapure water, and 60 μL of 0.1% FeCl3 were added, mixed thoroughly, and reacted in a 50℃ constant temperature water bath for 30 min. 200 μL of the reaction solution was taken and the absorbance value A1 was measured at 700 nm. The reaction mixture obtained by replacing the sample solution with ultrapure water served as the control group, and the absorbance value A2 was measured. Calculation formula: Total reducing power = A1 - A2.

[0078] Depend on Figure 1-2 It is evident that the scavenging ability of the extract from the traditional Chinese medicine compound decreases with increasing dilution factor, targeting both DPPH and ABTS free radicals. The IC50 of the extract against DPPH free radicals... 50 To dilute the stock solution 5.972 times, the IC50 of BHT was used as a reference. 50 The concentration was 0.066 mg / mL. The IC50 of the original extract of the traditional Chinese medicine compound against ABTS free radicals was... 50 To dilute the stock solution 34.541 times, control V C IC 50 The concentration ranged from 0.027 to 0.034 mg / mL. This indicates that the extract of the traditional Chinese medicine compound has a certain ability to scavenge DPPH and ABTS free radicals. Figure 3 The total reducing power of the extract from the traditional Chinese medicine compound is shown, indicating a negative correlation between dilution factor and total reducing power. Overall, this extract from the traditional Chinese medicine compound exhibits certain antioxidant activity.

[0079] Example 3: Preparation of concentrated extract of traditional Chinese medicine compound

[0080] The original extract of the traditional Chinese medicine compound from Example 1 was concentrated to obtain a concentrated extract of the traditional Chinese medicine compound at a concentration of 1 g / mL based on the initial weight of the raw materials. The specific steps are as follows:

[0081] The original extract of the traditional Chinese medicine compound obtained in Example 1 was first concentrated by rotary evaporation at 60°C until the solvent collection in the recovery bottle was slow. Then, the temperature was raised to 70°C and rotary evaporation was continued until the above condition was reached. Finally, the concentration was stopped at 75°C until the relative concentration of the extract was below 1 g / mL. Ultrapure water was added to make the concentration of the extract 1 g / mL based on the weight of the raw materials, thus obtaining the concentrated extract of the traditional Chinese medicine compound.

[0082] Example 4: Herbal Compound Wine

[0083] The concentrated extract of traditional Chinese medicine compound prepared in Example 3 was dispensed and frozen in a refrigerator at -20°C. After freezing, it was subjected to vacuum freeze-drying at -45°C for 48 hours to obtain freeze-dried powder of traditional Chinese medicine compound extract. An appropriate amount of freeze-dried powder was dissolved in 43% v / v% base wine to obtain traditional Chinese medicine compound wines of different concentrations.

[0084] Example of effect 1

[0085] Sixty healthy male ICR mice, 6 weeks old and weighing 20±2g, were acclimatized for one week under an environment of 24±2℃, 50%–60% relative humidity, 12 hours of alternating light and dark, and free access to water and food. They were then randomly divided into a control group (pure water) and three dosage experimental groups: a high-dose group (1g / mL) of extract (concentrated extract of traditional Chinese medicine compound), a medium-dose group (0.5g / mL) of extract, and a low-dose group (0.25g / mL) of extract, with 15 mice in each group. The mice in each experimental group were administered the corresponding solution by gavage at a volume of 0.1mL / 10g BW.

[0086] (1) Direct sleep test

[0087] Each group was administered the drug by gavage once daily for 7 consecutive days. After the last administration, the mice's sleep status was observed to conduct a direct sleep test. The number of mice falling asleep in each dose group and the blank group was 0, indicating that the Chinese herbal extract had no direct sleep effect on mice at the doses set in the experiment.

[0088] (2) Subthreshold dose hypnotic test with sodium pentobarbital

[0089] Each group was administered the drug once daily by gavage for 14 consecutive days. A subthreshold dose-induced hypnotic test of sodium pentobarbital was conducted 45–60 minutes after the last administration. Mice were intraperitoneally injected with sodium pentobarbital solution (36 mg / kg, injection volume 0.1 mL / 10 g), and the incidence of sleep in each group was recorded using the disappearance of the righting reflex as an indicator.

[0090] The experimental results are shown in Table 3. As can be seen from Table 3, the sleep rate of all extract groups was higher than that of the normal group, indicating that the extract can improve the sleep rate of mice. The high-dose extract group had the highest sleep rate of 73.3%.

[0091] Table 3. Effects of extracts on sleep rate in mice at subthreshold doses of sodium pentobarbital.

[0092] Group Laboratory animals / only Number of people falling asleep Sleep rate Blank group 15 3 20％ Low-dose extract group 15 9 60％ Medium dose group of extract 15 9 60％ High-dose extract group 15 11 73.3％

[0093] (3) Suprathreshold dose sleep test of sodium pentobarbital

[0094] Each group was administered the drug once daily by gavage for 21 consecutive days. A suprathreshold dose sleep test of sodium pentobarbital was conducted 45–60 minutes after the last administration. Mice were intraperitoneally injected with sodium pentobarbital solution (50 mg / kg, injection volume 0.1 mL / 10 g). The disappearance and recovery of the righting reflex were used as indicators, and the sleep latency and sleep duration of the mice were recorded.

[0095] The experimental results are shown in Table 4. Figure 4 , Figure 5 As shown in Table 4, compared with the blank group, the sleep latency of each dose group of the extract was shortened and there was a significant difference. Compared with the blank group (53.80±10.80) min, the sleep duration of each dose group of the extract was increased. Each dose group of the extract significantly prolonged the sleep time of mice, such as the high dose group (78.75±9.18) min.

[0096] Table 4. Effects of the extract on sleep at suprathreshold doses of sodium pentobarbital in mice.

[0097] Group Sleep latency / min Sleep duration / min Blank group <![CDATA[5.69±1.20 a ]]> <![CDATA[53.80±10.80 b ]]> Low-dose extract group <![CDATA[4.33±0.62 b ]]> <![CDATA[70.83±12.40 a ]]> Medium dose group of extract <![CDATA[3.80±0.54 b ]]> <![CDATA[72.54±11.93 a ]]> High-dose extract group <![CDATA[3.77±0.58 b ]]> <![CDATA[78.75±9.18 a ]]>

[0098] (4) Effects of concentrated extracts of traditional Chinese medicine compound on mouse body weight

[0099] Each group was administered the drug once daily by gavage for 30 consecutive days. During this period, the body weight of mice in each group was recorded, and changes in body weight were observed. Results are shown below. Figure 6 . Figure 6 It can be seen that the trend of weight change in each group of mice is basically the same, indicating that the extract has no effect on the normal growth of mice at the dose designed in this experiment.

[0100] (5) Effects of concentrated extracts of traditional Chinese medicine compound on organ indices in mice

[0101] Each group was administered the drug once daily by gavage for 30 consecutive days, followed by a 12-hour fast. Mice were then euthanized, their organs were removed and weighed, and the organ index was calculated. The organ index was calculated using the formula: Organ Index = Organ Index (mg) / Mouse Body Weight (g). The organ indices of each group are shown in Table 5. There were no statistically significant differences in organ indices among the groups, indicating that the dosage of the extract had no effect on the normal growth of mice at the designed experimental dose.

[0102] Table 5. Effects of the extract on organ indices in mice.

[0103] Group Heart Index Liver index Spleen index Lung Index Kidney Index Blank group 5.59±0.71 53.10±3.47 4.27±0.90 5.95±0.62 18.26±1.43 Low-dose extract group 5.47±0.70 53.00±4.89 4.44±0.83 6.37±0.95 18.15±1.18 Medium dose group of extract 5.14±0.44 51.41±5.30 3.68±1.05 6.19±0.84 19.17±1.62 High-dose extract group 5.09±0.50 49.92±3.14 4.08±0.86 6.01±0.66 19.23±1.80

[0104] Example 2

[0105] Seventy-five healthy male ICR mice, 6 weeks old and weighing 20±2g, were acclimatized for one week under an environment of 24±2℃, 50%–60% relative humidity, 12 hours of alternating light and dark, and free access to water and food. They were then randomly divided into three groups: a blank control group (pure water), a negative control group (base liquor), and three dosage experimental groups: a high-dose compound liquor group (3g / 50mL), a medium-dose compound liquor group (1.5g / 50mL), and a low-dose compound liquor group (0.75g / 50mL), with 15 mice in each group. Mice in each experimental group were administered the corresponding solution by gavage at a volume of 0.1mL / 10g BW. (The concentration of each dosage of compound liquor is calculated as: weight of the lyophilized powder of the compound herbal extract (g) / 43v / v% base liquor (mL)).

[0106] (1) Effects of different doses of compound wine on the subthreshold dose of sodium pentobarbital for hypnotic test in mice

[0107] Each group was administered the drug once daily by gavage for 21 consecutive days. A subthreshold dose-induced hypnotic test of sodium pentobarbital was conducted 45–60 minutes after the last administration. Mice were intraperitoneally injected with sodium pentobarbital solution (36 mg / kg, injection volume 0.1 mL / 10 g). The incidence of sleep in each group was recorded using the disappearance of the righting reflex as an indicator. The results are shown in Table 6.

[0108] Table 6. Effects of compound wine on sleep rate in mice at subthreshold doses of sodium pentobarbital.

[0109] Group Laboratory animals / only Falling asleep Sleep rate Blank group 15 2 20％ Base wine group 15 15 100％ low-dose compound wine group 15 15 100％ Compound wine medium dose group 15 15 100％ High-dose compound wine group 15 15 100％

[0110] Because all mice in the experimental groups except the control group fell asleep after intraperitoneal injection of sodium pentobarbital, the sleep latency and sleep duration of each group were recorded, as shown in Table 7. Figure 7 , Figure 8 As shown in the table, a significant analysis was performed on the base wine group and each dose of compound wine group. It can be seen from the table that each dose of compound wine group can significantly shorten the sleep latency and prolong the sleep duration of mice compared with the base wine group.

[0111] Table 7. Effects of compound wine on sleep latency and sleep duration in mice.

[0112] Group Sleep latency / min Sleep duration / min Blank group 16.00±1 18.50±1.50 Base wine group <![CDATA[5.50±1.68 a ]]> <![CDATA[44.44±12.25 b ]]> low-dose compound wine group <![CDATA[4.00±1.83 b ]]> <![CDATA[57.75±12.47 ab ]]> Compound wine medium dose group <![CDATA[3.83±1.14 b ]]> <![CDATA[60.90±15.93 a ]]> High-dose compound wine group <![CDATA[3.79±0.67 b ]]> <![CDATA[71.27±14.72 a ]]>

[0113] (2) Effects of different doses of compound wine on mouse body weight

[0114] Each group was administered the drug once daily by gavage for 30 consecutive days. During this period, the body weight of mice in each group was recorded, and changes in body weight were observed. Results are shown below. Figure 9 It can be seen that after about half a month of continuous drinking, the weight of mice showed a steady and gradual decrease, while the high-dose compound alcohol group showed a gradual increase, consistent with the blank group. This indicates that, to some extent, it can alleviate the effects of long-term alcohol consumption on the mice's body or daily diet and water intake.

[0115] (3) Effects of different doses of compound wine on ALT and AST in mouse liver

[0116] Each group was administered the drug once daily by gavage for 30 consecutive days. After fasting for 12 hours, the mice were sacrificed via myelotomy, and liver tissue was removed, rinsed with physiological saline, and surface moisture was blotted off with filter paper before use. The ALT and AST levels in the mouse liver tissue were measured strictly according to the ALT and AST kit instructions. The results are as follows: Figure 10 , 11 As shown in the figure, the levels of ALT and AST in the liver of mice in the base liquor group were significantly higher than those in the control group, indicating that long-term alcohol consumption leads to abnormal liver function. Compared with the base liquor group, the serum ALT and AST levels of mice in each dose of compound liquor group decreased, and the levels in the high-dose compound liquor group were significantly lower than those in the base liquor group. The results indicate that administering base liquor with compound extract can effectively alleviate the damage to the liver caused by alcohol.

[0117] (4) Effects of different doses of compound wine on inflammatory factors IL-1β, IL-6 and TNF-α in mouse liver

[0118] After homogenizing an appropriate amount of liver tissue, the levels of IL-1β, IL-6, and TNF-α were measured using a kit. The results are shown below. Figure 12 , 13 14. Compared with the control group, the levels of IL-1β, IL-6, and TNF-α in the liver tissue of mice that drank alcohol for a long time were significantly increased. The low and medium doses of compound alcohol could reduce the levels of IL-1β, IL-6, and TNF-α, and the high dose of compound alcohol significantly reduced the expression of the above inflammatory factors, indicating that compound alcohol can alleviate the increase in the levels of IL-1β, IL-6, and TNF-α inflammatory factors caused by drinking alcohol.

Claims

1. The use of a traditional Chinese medicine composition in the preparation of a health wine for improving sleep quality, characterized in that, The traditional Chinese medicine composition consists of the following components in parts by weight: 10 parts of Suanzaoren, 10 parts of Fuling, 6 parts of Zhuru, 5 parts of Chenpi, 3 parts of Guanghuoxiang, 5 parts of Gancao, 3 parts of Zhizi, 6 parts of Gegen, and 3 parts of Jinyinhua; The preparation method of the traditional Chinese medicine composition comprises the following steps: Suanzaoren, Fuling, Zhuru, Chenpi, Guanghuoxiang, Gancao, Zhizi, Gegen, and Jinyinhua are respectively crushed and sieved to prepare medicinal powder mixture, soaked in 60-70 v / v% base liquor, then ultrasonically broken, heated and extracted with the base liquor as solvent, and the extracted liquid is obtained by centrifugation; the health wine is prepared by dissolving the freeze-dried powder of the extracted liquid of the traditional Chinese medicine composition in 38-60 v / v% base liquor.

2. Use according to claim 1, characterized in that, The crushed and sieved mixed medicinal powder is soaked in 70 v / v% strong-flavor base liquor.

3. Use according to claim 1, characterized in that, In the preparation method of the traditional Chinese medicine composition, in the soaking process, the solid-liquid ratio of the mixed medicinal powder to the base liquor is 1: (30-50) g / mL; the soaking time is 0.5-2 h; the ultrasonic breaking power is 200-400 W, and the time is 8-15 min; the heating and extracting times are 2-3 times; the heating and extracting temperature is 60-70℃, and the extracting time is 0.5-1 h each time.

4. Use according to claim 1, characterized in that: The base liquor for dissolving the freeze-dried powder has a degree of 43 v / v%.

Images