Composition containing saffron crocus and application of composition in sleep improvement

Abstract

The invention discloses a composition containing saffron crocus powder and application of the composition in sleep improvement, the composition comprises the saffron crocus powder, chamomile powder and green tea extract, any two components can be compounded according to a specific proportion, or any three components can be compounded according to a specific proportion, the composition has a remarkable improvement effect on the sleep of mice, and the effect of improving the sleep of the mice is achieved. The composition is prepared from the following three components in parts by weight: 0.1-11 parts of saffron crocus powder, 0.08-8 parts of chamomile powder and 0.21-21 parts of green tea extract when being combined, and the improvement effect of compounding the three components is more remarkable and is equivalent to that of melatonin. The components of the composition are all derived from food raw materials, and are safe and reliable; the preparation process is simple and easy to implement, and industrial production and popularization are easy.

Description

Technical Field

[0001] This application relates to the fields of biomedicine and health food technology, specifically to a composition containing saffron and its application in improving sleep. Background Technology

[0002] According to the "China Sleep Research Report 2024," Chinese residents face serious sleep problems, with shallow sleep, difficulty falling asleep, and frequent awakenings being the most common sleep quality issues. Sleep disorders can lead to various health problems such as poor skin, memory loss, mood swings, dry and itchy eyes, and hair loss. In recent years, numerous studies have reported the potential of various food ingredients to improve sleep disorders.

[0003] For example, patent document CN104366510 A discloses a health food composition mainly composed of tea leaves, chamomile, γ-aminobutyric acid, DHA algal oil, 30-70 parts of taurine, and vitamins. Its main functions are to effectively relieve mental and physical stress, relax the mind, improve memory, lower blood pressure, and quickly relieve fatigue after a short rest. Patent document US8211674 discloses a method for producing chamomile through microbial fermentation, replacing traditional tea extraction methods and solving the problems of high raw material costs and low efficiency. Patent document EP17709170.9 discloses a saffron extract containing crocin and crocinic acid, used to treat human sleep disorders. The crocin content in the saffron extract is at least 2% of the total dry weight of the extract. Patent CN117256865 A discloses tea leaves, chamomile, jujube seed powder, egg yolk lecithin, casein hydrolysate, propolis, beeswax, and a mixed fermentation product.

[0004] However, existing products suffer from problems such as complex compound components, cumbersome preparation processes, lack of experimental data to support their synergistic effect on improving sleep, and low credibility. Summary of the Invention

[0005] This application provides a composition containing saffron and its application in improving sleep. Experiments have verified that the composition has a significant synergistic effect on improving sleep quality, and the components are simple and easy to prepare.

[0006] The Combination Index (CI) is a method for quantitatively evaluating drug interactions. It uses a mathematical model to calculate the combination index (CI value) to determine the combined effect of drugs: CI < 1 indicates a synergistic effect, CI = 1 indicates an additive effect, and CI > 1 indicates an antagonistic effect.

[0007] This application involved extensive screening of a range of food ingredients to identify a synergistic effect. Based on the combined index method, it explored the synergistic effects of various food ingredients with sleep-improving properties, developing a more efficient and safer food composition for improving sleep. The composition comprises saffron powder, chamomile powder, and green tea extract. Any two components can be combined in a specific ratio, or all three components can be combined in a specific ratio. Both compositions significantly improved sleep in mice, with the three-component combination showing a more pronounced effect, comparable to that of melatonin.

[0008] A composition for improving sleep, comprising three components in parts by weight: 0.1-11 parts saffron powder, 0.08-8 parts chamomile powder, and 0.21-21 parts green tea extract.

[0009] The components in the composition can be obtained commercially or prepared using conventional processing methods in the art. The forms of the components include, but are not limited to, powders, and can also be extracts, pastes, concentrates, slices, etc. Extracts can be water extracts or alcohol extracts, preferably water extracts. Those skilled in the art can adjust the formulation according to the actual situation. The preparation method of the composition is conventional mixing, for example, uniformly mixing the powdered raw materials. When compounding the three components, two components are compounded first, and then the third component is compounded.

[0010] Optionally, the green tea extract has a theanine content of not less than 20%; the chamomile powder has a chamomile polysaccharide content of not less than 5%; and the saffron powder has a crocin content of not less than 3.5%.

[0011] A preferred three-component compounding scheme involves mixing saffron powder and chamomile powder at a weight ratio of 20:1, and then further mixing the total weight of the two powders with the green tea extract at a weight ratio of 10:1 to 1:10. More preferably, the saffron powder and chamomile powder are mixed at a weight ratio of 20:1, and then further mixed with the green tea extract at a weight ratio of 10:1 or 1:10.

[0012] Another preferred three-component compounding scheme involves mixing the green tea extract and chamomile powder at a weight ratio of 10:1, and then further mixing the total weight of the two with saffron powder at a weight ratio of 10:1 to 1:10. More preferably, the green tea extract and chamomile powder are mixed at a weight ratio of 10:1, and then further mixed with saffron powder at a weight ratio of 10:1 or 1:10.

[0013] Another preferred formulation involves blending the green tea extract and saffron pollen at a weight ratio of 7:1, followed by blending the total weight of the two with chamomile powder at a weight ratio of 10:1 to 1:10. More preferably, the green tea extract and saffron pollen are blended at a weight ratio of 7:1, followed by blending the total weight of the two with chamomile powder at a weight ratio of 10:1 or 1:10.

[0014] When the composition is a pairwise combination: A compound formulation in which saffron powder and chamomile powder are compounded at a weight ratio of 1:20 to 20:1. Preferably, they are compounded at ratios of 1:20, 2:1, or 20:1.

[0015] Another formulation involves blending the green tea extract with chamomile powder at a weight ratio of 1:10 to 10:1. Preferably, the ratios are 1:10, 1:1, or 10:1, respectively.

[0016] Another compounding method involves mixing the green tea extract with saffron powder at a weight ratio of 1:7 to 7:1. Preferably, the ratios are 1:7, 1:1, or 7:1.

[0017] This application also provides the use of the composition in the preparation of sleep-improving products.

[0018] Optionally, the improvement of sleep includes, but is not limited to, increasing the sleep improvement rate, increasing the number of sleep rounds, sleep duration, and average sleep duration.

[0019] Optionally, the sleep-improving product may be a medicine or a health food.

[0020] When used in the preparation of health food products, the composition can be prepared with food-acceptable excipients according to conventional food preparation methods. The excipients include solvents, binders, fillers, sugars, and sweeteners, which can be selected according to different needs. The type of health food product can be any one of tablets, capsules, oral liquids, compressed candies, solid beverages, pills, granules, decoctions, pastes, syrups, drop pills, or tea bags. Further optionally, the health food product can be a solid beverage, compressed candy, or oral liquid.

[0021] More preferably, the composition, by weight, comprises: 0.7 parts green tea extract, 0.1 parts saffron powder, and 8 parts chamomile powder. When used to prepare an oral liquid, the amount of green tea extract added to the oral liquid is 0.84 mg / mL, the amount of saffron powder added is 0.12 mg / mL, and the amount of chamomile powder added is 9.6 mg / mL.

[0022] When used in pharmaceutical preparation, the composition can be prepared with pharmaceutically acceptable excipients according to conventional pharmaceutical preparation methods. Pharmaceutically acceptable excipients include buffer solutions, emulsifiers, suspending agents, disintegrants, disintegrants, dispersants, binders, excipients, stabilizers, chelating agents, diluents, gelling agents, preservatives, wetting agents, lubricants, absorption delay agents, liposomes, etc., which can be selected according to different needs. The dosage forms of the pharmaceutical product include granules, tablets, capsules, powders, oral liquids, pellets, microcapsules, or injections.

[0023] In the aforementioned health foods and pharmaceuticals, the amount and proportion of the composition and related excipients of the present invention can be adjusted according to actual needs.

[0024] The active ingredients in saffron, such as crocin, crocinic acid, and crocin glycosides, significantly improve sleep-related indicators such as sleep onset time, sleep quality, and sleep duration through multiple pathways, including regulating neurotransmitters, promoting melatonin secretion, relieving anxiety and depression, and improving blood circulation. Green tea extract, rich in theanine, a natural non-protein amino acid, significantly improves sleep quality by regulating neurotransmitter balance, promoting alpha wave activity, and synergistically working with gamma-aminobutyric acid (GABA). Chamomile powder contains flavonoids (such as apigenin) and terpenoids (such as bisabolol) that can bind to benzodiazepine receptors and GABA receptors, regulating neurotransmitter levels (such as GABA and serotonin), thereby producing a calming and relaxing effect and promoting sleep.

[0025] Saffron powder, green tea extract, and chamomile powder improve sleep phenotypes such as sleep onset time, sleep quality, and sleep duration through melatonin receptor, γ-aminobutyric acid receptor, and benzodiazepine receptor pathways, respectively, and have significant synergistic potential to promote sleep.

[0026] Compared with the prior art, this application has the following beneficial effects: This application verifies the effect of the composition on improving sleep in accordance with the standard method of "Methods for Testing and Evaluating the Functions of Health Products". The results show that the compound powder of green tea extract, saffron powder and chamomile powder improves sleep in mice by increasing 5-hydroxytryptamine level and γ-aminobutyric acid / glutamate ratio, and decreasing glutamate level.

[0027] This application also evaluated the sleep-improving effects of a pilot-scale beverage prepared based on the compound composition of green tea extract, saffron powder, and chamomile powder by recruiting volunteers. The results showed that after 7 days of consumption of the compound beverage, 86% of the subjects experienced a shorter time to fall asleep, 88% experienced a longer total sleep time, 87% experienced improved sleep quality, and 90% experienced improved mental state upon waking. Sleep data recordings over 7 consecutive days showed that with prolonged consumption, the subjects' time to fall asleep, total sleep time, sleep quality, and mental state upon waking all continued to improve.

[0028] When the three components of this application are combined, their sleep-improving effect on mice can reach the level of melatonin under specific ratios.

[0029] The components of the composition in this application are all derived from food raw materials, making them safe and reliable; the preparation process is also simple and easy to carry out, facilitating industrial production and promotion. Detailed Implementation

[0030] The technical solution of this application will be clearly and completely described below with reference to specific embodiments. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0032] Saffron powder, chamomile powder, and green tea extract can be obtained directly from the market. In the following examples and comparative examples, the saffron powder (crocin content not less than 3.5%), green tea extract (theanine content not less than 20%), and chamomile powder (chamomile polysaccharide content not less than 5%) used were all purchased from the market and are in powder form. In the two-component combinations, the two powder raw materials are thoroughly mixed according to the specified ratio; in the three-component combinations, two components are mixed according to a specific ratio before being thoroughly mixed with the third component.

[0033] In addition to the above-mentioned purchase channels, saffron powder, chamomile powder, and green tea extract can also be prepared by purchasing the corresponding raw materials and extracting them at home. The qualified saffron, green tea and chamomile were pulverized into micro powders. They were then extracted in a multi-functional extraction tank at a suitable material-liquid ratio (1:10-1:40) with water or a low proportion of ethanol as solvents. The extraction was carried out at 45-100℃ for 1 hour, filtered through gauze, concentrated through a membrane and freeze-dried to obtain powders, namely saffron powder, green tea extract and chamomile powder, or a mixture extract could be obtained directly.

[0034] The formulations of the compositions in Examples 1-15 are shown in the table: Table 1 Composition Formulation

[0035] Experimental Example 1 Six-day-old wild-type AB strain zebrafish were selected. A pentylenetetrazol-induced insomnia model was used, with melatonin as a positive control. The melatonin concentration was set at 100 μM. The compound ingredients and results are shown in Table 2. Among them, green tea extract (EC50: 45.4 μg·mL⁻¹) was included. -1 ), Saffron pollen (EC50: 322.4 μg·mL) -1 ) and chamomile powder (EC50 is 160 μg·mL) -1 Dosage was set according to their respective EC50 values; the dosage of passion fruit extract was set at 200 μg / mL. -1 The dosage of tryptophan was set at 30 μg / mL. -1 The dosage of jujube powder was set at 300 μg / mL. -1 .

[0036] Before the behavioral experiment began, pentylenetetrazol solution was added to the water in each group of animals, and melatonin stock solution and treatment group stock solution were added drop by drop in time to ensure that the dosage met the experimental setting.

[0037] The movement trajectories of zebrafish were recorded using a behavioral analyzer over one hour. Movement speed was categorized as follows: below 0.5 cm / s was considered slow, 0.5–2 cm / s was medium, and above 2 cm / s was high. Slow movement lasting ≥6 seconds within one hour was counted as one sleep cycle. The total number of sleep cycles was the total number of sleep rounds, and the sleep duration was the sum of all sleep times. The average sleep duration was the average of the total sleep duration.

[0038] The formula for calculating sleep improvement rate is as follows: Sleep improvement rate = 100 × (total high-speed movement distance of the model group - total high-speed movement distance of the treatment group) / total high-speed movement distance of the model group.

[0039] Table 2. Screening of raw materials for sleep-improving compound formulations based on zebrafish insomnia model.

[0040] Note: " / " indicates no numerical value; statistical differences compared to the model group are marked with *. p <0.05,** p <0.01, *** p <0.001; a statistically significant difference compared to the control group is denoted as #. p <0.05, ## p <0.01, ### p <0.001.

[0041] This experimental study evaluated the effects of six food ingredients (green tea extract, saffron powder, chamomile powder, passionflower extract, tryptophan, and jujube powder) on improving the insomnia phenotype. The indicators are ranked as follows: Sleep improvement rate: Green tea extract > Chamomile powder > Saffron powder > Passionflower extract > Jujube powder > Tryptophan; Number of sleep rounds: Green tea extract > Saffron powder > Chamomile powder > Jujube powder > Passionflower extract > Tryptophan; Sleep duration: Saffron powder > Chamomile powder > Green tea extract > Jujube powder > Passionflower extract > Tryptophan.

[0042] The results showed that green tea extract and chamomile powder could improve sleep improvement rate, and their combination may have a synergistic effect, reducing the effective dosage; green tea extract and saffron powder significantly increased the number of sleep rounds, and their combination may produce a synergistic effect; saffron powder and chamomile powder significantly prolonged sleep duration, and their combination may have a synergistic effect.

[0043] Taking into account the improvement effects and contribution rates of each ingredient, this study selected green tea extract, chamomile powder, and saffron powder as the core ingredients of the sleep-improving compound formula. Based on verifying the combined effect of two ingredients, a third ingredient was further combined to confirm the synergistic effect of the three ingredients.

[0044] Experimental Example 2 The experimental method was the same as in Experiment 2. The compound raw materials and results are shown in Table 3.

[0045] Table 3. Effects of saffron pollen and chamomile complex on sleep in zebrafish.

[0046] Note: The dosages used in Examples 1, 2, and 3 are all 50% effective doses; " / " indicates no numerical value; statistical differences compared to the model group are marked with *. p <0.05,** p <0.01, *** p <0.001.

[0047] As shown in Table 3, zebrafish treated with saffron pollen and chamomile alone experienced a 51.6% and 50.7% increase in sleep duration, respectively, compared to the model group. Based on the EC50 (median effective concentration), this study set the compound ratios of saffron pollen and chamomile at 2:1, 1:20, and 20:1. The results showed that the compound improved sleep duration by 55.4% (2:1), 62.4% (1:20), and 64.7% (20:1), respectively, with corresponding combination indices (CI values) of 0.69, 0.71, and 0.76, all less than 1. This indicates that within the ratio range of 1:20 to 20:1, saffron pollen and chamomile powder have a synergistic effect on improving sleep duration. Furthermore, the complex increased the number of sleep rounds by 30.4% (2:1), 35.4% (1:20), and 38.6% (20:1), respectively, corresponding to sleep improvement rates of 43.8%, 47.7%, and 50.4%, and an increase in average sleep duration of 19.4%, 20.4%, and 19.4%, respectively. These results further confirm the synergistic effect of the saffron pollen and chamomile powder complex on zebrafish sleep. Both saffron pollen and chamomile powder significantly improved sleep quality in zebrafish at different ratios, exhibiting a synergistic effect within the range of 1:20 to 20:1, but there was still a certain gap compared to the positive control melatonin.

[0048] Experimental Example 3 The experimental method was the same as in Experiment 1. The compound raw materials and results are shown in Table 4.

[0049] Table 4. Effects of green tea extract and chamomile powder complex on sleep in zebrafish.

[0050] Note: The dosages used in Examples 4, 5, and 6 were all 50% effective doses; " / " indicates no numerical value; statistical differences compared to the model group are marked with *. p <0.05,** p <0.01, *** p <0.001.

[0051] According to Table 4, the sleep improvement rates of zebrafish treated with green tea extract and chamomile powder alone were 42.5% and 30.8%, respectively. Based on the EC50 value, this study set three compound ratios: 1:1, 10:1, and 1:10. The experimental results showed that the compound improved the sleep improvement rate by 45.3% (1:1), 51.1% (10:1), and 58.3% (1:10), respectively, with corresponding CI values ​​of 0.52, 0.44, and 0.43, all less than 1. This indicates that within the ratio range of 1:10 to 10:1, the green tea extract and chamomile powder compound significantly improved the sleep improvement rate and exhibited a synergistic effect. Furthermore, the complex increased the number of sleep rounds by 37.8% (1:1), 34.6% (10:1), and 36.5% (1:10), respectively; the total sleep duration increased by 53.4% ​​(1:1), 55.6% (10:1), and 58.6% (1:10), respectively; and the average sleep duration increased by 11.6% (1:1), 15.8% (10:1), and 16.3% (1:10), respectively. These results further confirm the significant effect of the green tea extract and chamomile powder complex on improving sleep quality in zebrafish. Within a compound ratio range of 1:10 to 10:1, green tea extract and chamomile powder significantly improved the sleep improvement rate in zebrafish, increased the number of sleep rounds, total sleep duration, and average sleep duration, and showed a synergistic effect, but there was still a certain gap compared with the positive control melatonin.

[0052] Experiment Example 4 The experimental method was the same as in Experiment 1. The compound raw materials and results are shown in Table 5.

[0053] Table 5. Effects of green tea extract and saffron pollen complex on sleep in zebrafish.

[0054] Note: The dosages used in Examples 7, 8, and 9 were all 50% effective doses; " / " indicates no numerical value; statistical differences compared to the model group are marked with *. p <0.05,** p <0.01, *** p <0.001.

[0055] According to the data in Table 5, the number of sleep rounds in zebrafish treated with green tea extract and saffron pollen alone increased by 31.4% and 28.9% respectively compared to the model group, showing potential for improving the number of sleep rounds. Based on EC50 values, this study set three compound ratios: 1:1, 7:1, and 1:7. The results showed that the compound's effect on improving the number of sleep rounds was 36.5% (1:1), 42.1% (7:1), and 47.8% (1:7), respectively, with corresponding combination indices of 0.82, 0.69, and 0.73, all less than 1. This indicates that within the ratio range of 1:7 to 7:1, the green tea extract and saffron pollen compound have a synergistic effect on improving the number of sleep rounds. Furthermore, the sleep improvement rates of the complex were 50.3% (1:1), 57.2% (7:1), and 64.2% (1:7), respectively, with sleep duration increasing by 1.6-fold (1:1), 1.7-fold (7:1), and 1.8-fold (1:7), respectively, and average sleep duration increasing by 19.8% (1:1), 16.6% (7:1), and 19.3% (1:7), respectively. These results further confirm the significant effect of the green tea extract and saffron complex on improving sleep quality in zebrafish. Within a compound ratio range of 1:7 to 7:1, green tea extract and saffron significantly increased the number of sleep rounds, sleep improvement rate, sleep duration, and average sleep duration in zebrafish, exhibiting a synergistic effect, but still showing a certain gap compared to the positive control melatonin.

[0056] Experimental Example 5 The experimental method was the same as in Experiment 1. The compound raw materials and results are shown in Table 6.

[0057] Table 6. Effects of green tea extract, saffron pollen, and chamomile powder complex on sleep in zebrafish.

[0058] Note: The dosages used in each example are 50% of the effective dose; " / " indicates no numerical value; statistical differences compared to the model group are marked with *. p <0.05,** p <0.01, *** p <0.001.

[0059] As shown in Table 6, the sleep improvement rates of zebrafish treated with green tea extract, saffron powder, and chamomile powder individually were 48.5%, 26.3%, and 37.1%, respectively. Moreover, the number of sleep rounds, sleep duration, and average sleep duration were all significantly increased compared with the model group, showing the potential to improve sleep.

[0060] Based on the experimental results, the combination of green tea extract, saffron powder, and chamomile powder in pairs showed significant synergistic effects. This study used fixed-ratio combinations of powders for experiments: saffron and chamomile powder (20:1), green tea extract and chamomile powder (10:1), and green tea extract and saffron powder (7:1). The results showed that the sleep improvement rates of the combination powders were 40.2%, 47.5%, and 53.7%, respectively, with CI values ​​of 0.79, 0.74, and 0.69, all less than 1, indicating a synergistic effect in each combination. Furthermore, the combination powders improved the number of sleep rounds, sleep duration, and average sleep duration by: 33.8%, 36.3%, and 36.9% in the number of sleep rounds; 50.8%, 49.8%, and 52.1% in sleep duration; and 12.4%, 9.7%, and 11.3% in average sleep duration.

[0061] Further experiments showed that when saffron and chamomile compound powder (20:1) was combined with green tea extract at a ratio of 10:1, the number of sleep rounds increased by 39.4%, sleep duration increased by 60.9%, average sleep duration increased by 15.6%, and the sleep improvement rate was 59.8%, with a CI value of 0.66; when combined at a ratio of 1:10, the number of sleep rounds increased by 41.3%, sleep duration increased by 63.3%, average sleep duration increased by 15.6%, and the sleep improvement rate was 64.3%, with a CI value of 0.63.

[0062] When green tea extract and chamomile compound powder (10:1) were combined with saffron powder, the following results were observed: at a 10:1 ratio, the number of sleep rounds increased by 42.5%, sleep duration increased by 75.0%, average sleep duration increased by 22.6%, sleep improvement rate was 68.5%, and CI value was 0.62; at a 1:10 ratio, the following results were observed: the number of sleep rounds increased by 44.4%, sleep duration increased by 80.4%, average sleep duration increased by 24.7%, sleep improvement rate was 72.6%, CI value was 0.5, and the improvement effect was comparable to that of the positive control melatonin.

[0063] When the green tea extract and saffron compound powder (7:1) was combined with chamomile powder at a ratio of 10:1, the sleep improvement rate was 75.6% (CI value 0.39); the number of sleep rounds increased by 45.6%, sleep duration increased by 84.7%, and average sleep duration increased by 26.9%. At a ratio of 1:10, the sleep improvement rate was 78.1% (CI value 0.33); the number of sleep rounds increased by 46.9%, sleep duration increased by 87.7%, and average sleep duration increased by 27.4%. All compound combinations had CI values ​​less than 1, indicating a significant synergistic effect. Furthermore, the green tea extract and saffron compound powder (7:1) combined with chamomile powder at a ratio of 10:1 showed a better improvement effect than the positive control melatonin.

[0064] In summary, green tea extract, saffron powder, and chamomile powder, when combined in pairs or in all three proportions within the range of 1:7 to 7:1, can significantly improve sleep and exhibit synergistic effects. When combined in all three proportions, they have an even better synergistic effect, and their improvement effect is comparable to that of the positive control melatonin.

[0065] Experimental Example 6 To determine the effects of a complex of green tea extract, saffron pollen, and chamomile powder on sleep phenotypes and biochemical indicators, and to provide data support for subsequent product development, this study, based on the compound formulation and dosage validated in zebrafish experiments, converted the dosage into mouse intake doses according to the dosage conversion method in patent CN113496071A, and verified its sleep-improving effect according to the standard method of "Methods for Functional Testing and Evaluation of Health Products". The specific results are as follows: Table 7. Effects of green tea extract, saffron pollen, and chamomile powder complex on sleep and related indicators in mice.

[0066] Note: " / " indicates no numerical value; statistical differences compared to the model group are marked with *. p <0.05,** p <0.01, *** p <0.001.

[0067] According to the data in Table 6, diazepam, as a positive control, shortened the sleep latency by 32.4%, increased the sleep duration by 78.6%, increased the 5-hydroxytryptamine level by 41.0%, increased the γ-aminobutyric acid / glutamate ratio by 20.0%, and decreased the glutamate level by 31.2% in mice, indicating that it significantly improved the sleep phenotype in mice.

[0068] A blend of saffron and chamomile powder (20:1) and green tea extract: At a 10:1 ratio: sleep latency decreased by 13.9%, sleep duration increased by 27.8%, serotonin levels increased by 12.7%, the GABA / glutamate ratio increased by 6.2%, and glutamate levels decreased by 10.3%. At a 1:10 ratio: sleep latency decreased by 20.2%, sleep duration increased by 24.1%, serotonin levels increased by 15.5%, the GABA / glutamate ratio increased by 9.2%, and glutamate levels decreased by 7.3%.

[0069] A blend of green tea extract and chamomile powder (10:1) with saffron: At a 10:1 ratio: sleep latency decreased by 22.2%, sleep duration increased by 35.6%, serotonin levels increased by 20.6%, the GABA / glutamate ratio increased by 12.3%, and glutamate levels decreased by 15.2%. At a 1:10 ratio: sleep latency decreased by 23.8%, sleep duration increased by 38.4%, serotonin levels increased by 25.8%, the GABA / glutamate ratio increased by 13.8%, and glutamate levels decreased by 17.3%.

[0070] A mixture of green tea extract and saffron powder (7:1) with chamomile: At a ratio of 10:1, sleep latency decreased by 28.9%, sleep duration increased by 56.0%, serotonin levels increased by 30.1%, the GABA / glutamate ratio increased by 18.5%, and glutamate levels decreased by 22.2%. At a ratio of 1:10, sleep latency decreased by 31.2%, sleep duration increased by 72.6%, serotonin levels increased by 38.9%, the GABA / glutamate ratio increased by 15.4%, and glutamate levels decreased by 27.7%, approaching the levels of the positive control diazepam.

[0071] In summary, the compound powder of green tea extract, saffron, and chamomile significantly shortened sleep latency and increased sleep duration by increasing serotonin levels and the γ-aminobutyric acid / glutamate ratio, and decreasing glutamate levels, thus improving sleep in mice. The formulation in Example 15 showed effects similar to the positive control. According to the standard "Methods for Functional Testing and Evaluation of Health Foods," the composition of this invention has significant sleep-improving effects.

[0072] Experimental Example 6 This experiment recruited 65 volunteers through a work group and assessed their sleep quality using the Pittsburgh Sleep Quality Index (PSQI) questionnaire and polysomnography (PSG). After screening, 30 volunteers with PSQI scores of 7-10 (mild sleep disorder) and 10-15 (moderate sleep disorder) were selected as test subjects. No control group was included in the experiment; the sleep improvement effect was tracked only after the test subjects continuously consumed a pilot-scale production beverage (formulation as in Example 15, containing 21 mg of green tea extract, 3 mg of saffron powder, and 240 mg of chamomile powder dissolved in 25 ml of purified water, sterilized and packaged, and administered to volunteers 10-30 minutes before bedtime) for 7 days. A total of 30 valid questionnaires were collected, and the statistical results are as follows: Table 8. Clinical trials of the formula in Example 15 to improve sleep and its sustained improvement over 7 days.

[0073] Table 7 shows that after 7 days of taking a compound beverage of green tea extract, saffron powder, and chamomile powder, 86% of the subjects experienced a shorter time to fall asleep, 88% experienced a longer total sleep time, 87% experienced improved sleep quality, and 90% experienced improved mental state upon waking. Sleep data recorded over 7 consecutive days showed that with prolonged use, the subjects' time to fall asleep, total sleep time, sleep quality, and mental state upon waking all continued to improve. The results indicate that this compound beverage has a significant improving effect on mild and moderate sleep disorders, and the effect continues to improve.

[0074] Comparative Example Table 8 shows the comparative proportions of raw materials and results. All raw materials were obtained through market purchases. Specific results are as follows: Comparative Example 1 The components (parts by weight) in this formula are: 1 part passion fruit extract and 8 parts jujube seed powder.

[0075] Comparative Example 2 The components (parts by weight) in this formula are: 2 parts passionflower extract and 7 parts jujube seed powder.

[0076] Comparative Example 3 The components (parts by weight) in this formula are: 8 parts passionflower extract and 1 part jujube seed powder.

[0077] Comparative Example 4 The components (parts by weight) in this formula are: 8 parts passionflower extract, 1 part jujube seed powder, and 1 part asparagus extract.

[0078] The zebrafish experiment was conducted using the same method as in Experimental Example 1, and the results are as follows: Table 9. Effects of comparative studies on zebrafish sleep

[0079] Table 8 shows that when passion fruit extract, jujube seed powder, and asparagus extract were used alone, sleep duration increased by 20.9%, 23.9%, and 4.6% respectively compared to the model group, with corresponding sleep improvement rates of 18.4%, 21.3%, and 4.2%, indicating that these ingredients, when used individually, have sleep-improving effects. However, when combined in pairs or in all three combinations, although the sleep improvement rate increased, the CI values ​​were 1.44, 1.58, 1.66, and 1.82, respectively, all greater than 1. This indicates that these combinations did not show a synergistic effect, and also suggests that single ingredients with sleep-improving effects may not necessarily produce a synergistic effect when combined.

[0080] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A composition for improving sleep, characterized in that, The composition by weight is: 0.1-11 parts saffron powder, 0.08-8 parts chamomile powder, and 0.21-21 parts green tea extract.

2. The composition according to claim 1, characterized in that, The saffron powder contains no less than 3.5% crocin by mass; the chamomile powder contains no less than 5% chamomile polysaccharide by mass; and the green tea extract contains no less than 20% theanine by mass.

3. The composition according to claim 1, characterized in that, The saffron powder and chamomile powder are compounded at a weight ratio of 20:1, and then compounded with green tea extract at a weight ratio of 10:1 to 1:

10.

4. The composition according to claim 1, characterized in that, The green tea extract and chamomile powder are compounded at a weight ratio of 10:1, and then compounded with saffron powder at a weight ratio of 10:1 to 1:10 based on the total weight of the two.

5. The composition according to claim 1, characterized in that, The green tea extract and saffron powder are compounded at a weight ratio of 7:1, and then compounded with chamomile powder at a weight ratio of 10:1 to 1:

10.

6. The composition according to claim 4, characterized in that, The green tea extract and saffron powder are compounded in a weight ratio of 7:1, and then compounded with chamomile powder in a weight ratio of 10:1 or 1:10 based on the total weight of the two.

7. The use of the composition according to any one of claims 1 to 6 in the preparation of a sleep-improving product.

8. The application according to claim 7, characterized in that, The sleep-improving products mentioned are medicines or health foods.

9. The application according to claim 8, characterized in that, The health food products mentioned are solid beverages, compressed candies, or oral liquids.

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