A composition containing saffron and its use in improving sleep

Abstract

The application discloses a composition containing saffron powder and application thereof in improving sleep, and components of the composition include saffron powder, chamomile powder and green tea extract, and the composition can be any two components compounded in a specific proportion or three components compounded in a specific proportion, and the composition has a significant improvement effect on sleep of mice; when the composition is the combination of the three components, the composition is composed of the saffron powder 0.1-11 parts, the chamomile powder 0.08-8 parts and the green tea extract 0.21-21 parts by weight, and the improvement effect of the three components compounded is more significant and is equivalent to the effect of melatonin. The components of the composition are all derived from food raw materials, are safe and reliable, the preparation process is simple and easy to implement, and the composition is easy to be industrialized and popularized.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of biological medicine and health food, in particular to a composition containing saffron and application thereof in improving sleep. BACKGROUND

[0002] According to the results of the China Sleep Research Report 2024, Chinese residents are facing serious sleep problems. Shallow sleep, difficulty falling asleep, and easy waking are the most common sleep quality problems. Sleep disorders can lead to a variety of health problems such as poor skin, memory loss, emotional disorders, dry eyes, and hair loss. In recent years, numerous literature reports that a variety of food raw materials have the potential to improve sleep disorders.

[0003] For example, patent document CN104366510 A discloses a health food composition mainly composed of tea chamomile, gamma-aminobutyric acid, DHA algal oil, taurine 30-70 parts, and vitamins. The main function is to effectively relieve physical and mental stress, relax mood, improve memory, and reduce blood pressure. After work, a short rest can quickly relieve fatigue. Patent document US8211674 discloses a method for producing chamomile by microbial fermentation to replace the traditional tea extraction method, solving the problems of high raw material cost and low efficiency. Patent document EP17709170.9 discloses a saffron extract containing crocin and saffronic acid for treating sleep disorders in humans. The content of crocin in the saffron extract is at least 2% of the total weight of dry matter. Patent CN117256865 A discloses tea chamomile, jujube kernel powder, egg yolk lecithin, casein hydrolysate, propolis, beeswax, and mixed fermentation.

[0004] However, the existing products have the problems of complex compound components, complicated preparation process, or lack of sleep improvement synergy and lack of experimental data support. SUMMARY

[0005] The present application provides a composition containing saffron and application thereof in improving sleep. The composition has a significant synergistic effect on improving sleep quality, and the components are simple and easy to prepare.

[0006] Combination Index (CI) is a method for quantitatively evaluating drug interactions. The combination index (CI value) is calculated by a mathematical model to judge the effect of drug combination: CI < 1 for synergistic effect, CI = 1 for additive effect, and CI > 1 for antagonistic effect.

[0007] The present application is screened from a series of food raw materials, and based on the joint index method, the synergistic effect of a variety of food raw materials with sleep improvement effect is explored, and a more efficient and safer sleep improvement food composition is developed. The composition of the composition includes saffron powder, chamomile powder and green tea extract, which can be any two components compounded in a specific ratio, or three components compounded in a specific ratio, which can significantly improve the sleep of mice, and the improvement effect of three components is more significant, which is comparable to the effect of melatonin.

[0008] A composition for improving sleep, the composition is a combination of three components, and the composition is composed of saffron powder 0.1-11 parts, chamomile powder 0.08-8 parts, and green tea extract 0.21-21 parts by weight.

[0009] The source of each component in the composition can be obtained by purchase, or can be prepared by conventional processing method in the art. The form of each component includes but is not limited to powder, and can also be extract, extract, concentrate, slice, etc. The extract can be water extract, or alcohol extract, preferably water extract, and the skilled person in the art can adjust the compounding according to the actual situation. The preparation method of the composition is conventional mixing, for example, uniformly mixing each powdered raw material, and compounding two components first and then compounding with the third component.

[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 is that the saffron powder and chamomile powder are compounded at a weight ratio of 20:1, and then compounded with the green tea extract at a weight ratio of 10:1 to 1:10 of the total weight of the two to the weight of the green tea extract. Further preferably, the saffron powder and chamomile powder are compounded at a weight ratio of 20:1, and then compounded with the green tea extract at a weight ratio of 10:1 or 1:10 of the total weight of the two to the weight of the green tea extract.

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

[0013] In another preferred combination of three, the green tea extract and the saffron powder are combined at a weight ratio of 7:1, and then combined with the chamomile powder at a weight ratio of 10:1 to 1:10 of the total weight of the two to the weight of the chamomile powder. Further preferably, the green tea extract and the saffron powder are combined at a weight ratio of 7:1, and then combined with the chamomile powder at a weight ratio of 10:1 or 1:10 of the total weight of the two to the weight of the chamomile powder.

[0014] When the composition is combined two by two, the combination of the green tea extract and the saffron powder is preferably combined at a weight ratio of 7:1, and then combined with the chamomile powder at a weight ratio of 10:1 to 1:10 of the total weight of the two to the weight of the chamomile powder.

[0015] In one combination, the saffron powder and the chamomile powder are combined at a weight ratio of 1:20 to 20:1. Preferably, they are combined at a weight ratio of 1:20, 2:1 or 20:1, respectively.

[0016] In another combination, the green tea extract and the chamomile powder are combined at a weight ratio of 1:10 to 10:1. Preferably, they are combined at a weight ratio of 1:10, 1:1 or 10:1, respectively.

[0017] In another combination, the green tea extract and the chamomile powder are combined at a weight ratio of 1:10 to 10:1. Preferably, they are combined at a weight ratio of 1:10, 1:1 or 10:1, respectively.

[0018] The present application also provides a use of the composition in the preparation of a sleep improvement product.

[0019] Optionally, the sleep improvement includes, but is not limited to, improving sleep improvement rate, increasing sleep round number, sleep duration and average sleep duration.

[0020] Optionally, the sleep improvement product is a drug or a health food.

[0021] For the preparation of a health food, the composition can be prepared with food acceptable adjuvants according to conventional food preparation methods. The adjuvants include solvents, binders, fillers, sugars and sweeteners, etc., which can be selected according to different needs. The type of health food can be any one of tablets, capsules, oral liquids, tablet candies, solid beverages, pills, granules, decoctions, pastes, lotions, dripping pills or syrups or tea bags. Further optionally, the health food is a solid beverage, a tablet candy or an oral liquid.

[0022] Further preferably, the composition comprises, by weight: 0.7 parts of green tea extract, 0.1 parts of saffron powder and 8 parts of chamomile powder. When it is used to prepare an oral liquid, the green tea extract is added in an amount of 0.84 mg / mL, the saffron powder is added in an amount of 0.12 mg / mL and the chamomile powder is added in an amount of 9.6 mg / mL.

[0023] For the preparation of the medicine, the composition can be prepared with pharmaceutically acceptable adjuvants according to conventional medicine preparation methods, including buffers, emulsifiers, suspending agents, decomposing agents, disintegrating agents, dispersing agents, binding agents, excipients, stabilizing agents, chelating agents, diluents, gelling agents, preservatives, wetting agents, lubricants, absorption retardants, liposomes, etc., which can be selected according to different needs. The dosage form of the medicine includes granules, tablets, capsules, granules, granules, oral liquids, dripping pills, micro-pellets or injections, etc.

[0024] In the above health food and medicine, the addition amount and addition ratio of the composition and related adjuvants of the application can be adjusted according to actual needs.

[0025] The active ingredients such as crocin, crocetin and crocin in saffron can significantly improve sleep-related indicators such as sleep onset time, sleep quality and duration through multiple pathways such as regulating neurotransmitters, promoting melatonin secretion, relieving anxiety and depression, and improving blood circulation. Theanine, rich in green tea extract, is a natural non-protein amino acid, which can significantly improve sleep quality by regulating neurotransmitter balance, promoting alpha wave activity, and synergistic effect with gamma-aminobutyric acid. Flavonoids (such as apigenin) and terpenes (such as bisabolol) in chamomile powder can bind to benzodiazepine receptors and gamma-aminobutyric acid (GABA) receptors, regulate the levels of neurotransmitters (such as GABA and serotonin), and produce sedative and relaxing effects, thereby promoting sleep.

[0026] Saffron powder, green tea extract and chamomile powder can improve sleep phenotypes such as sleep onset time, sleep quality and duration from melatonin receptor, gamma-aminobutyric acid receptor and benzodiazepine receptor pathways, respectively, and have significant synergistic sleep-promoting potential.

[0027] Compared with the prior art, the present application has the following beneficial effects:

[0028] According to the standard method of "Health Product Function Test and Evaluation Method", the effect of the composition on improving sleep is verified, and the results show that the green tea extract, saffron powder and chamomile powder compound powder can significantly shorten the sleep latency, increase the sleep time and improve the sleep of mice by increasing the 5-hydroxytryptamine level and the ratio of gamma-aminobutyric acid / glutamic acid and reducing the glutamic acid level.

[0029] The application also evaluates the sleep improvement effect of the pilot drink prepared based on the three-component combination composition by recruiting volunteers. The results show that after taking the green tea extract, saffron powder and chamomile powder composite drink for 7 days, 86% of the subjects have shortened sleep time, 88% of the subjects have prolonged total sleep time, 87% of the subjects have improved sleep quality, and 90% of the subjects have improved mental state after waking up. The sleep data record for 7 consecutive days shows that as the taking time is prolonged, the sleep time, total sleep time, sleep quality and mental state after waking up of the subjects are continuously improved.

[0030] When the composition of the application is combined with three components, the sleep improvement effect on mice can reach the level of melatonin at a specific ratio.

[0031] The components of the composition of the application are all derived from food raw materials, which are safe and reliable. The preparation process is also simple and easy to implement, and is easy to industrialize and popularize. DETAILED DESCRIPTION

[0032] The technical solutions of the application will be described below in conjunction with specific examples. Obviously, the described examples are only part of the examples of the application, not all examples. Based on the examples in the application, all other examples obtained by those skilled in the art without creative labor are within the scope of protection of the application.

[0033] 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 the application belongs. The terms used in the specification of the application herein are only for the purpose of describing specific examples and are not intended to limit the application.

[0034] Saffron powder, chamomile powder and green tea extract can be directly purchased from the market. The saffron powder (saffron glycoside content not less than 3.5%), green tea extract (tea amino acid content not less than 20%) and chamomile powder (chamomile polysaccharide content not less than 5%) used in the following examples and comparative examples are all derived from market purchase, in the form of powdered extract. The two-component combination composition is prepared by mixing the two powdered raw materials according to the ratio; the three-component combination composition is prepared by mixing two components according to a specific ratio and then mixing with the third component.

[0035] In addition to the above purchase methods, saffron powder, chamomile powder and green tea extract can also be prepared by purchasing corresponding raw materials and extracting them by themselves:

[0036] The qualified saffron, green tea and chamomile are respectively crushed into micro-powder, respectively using water or low proportion of ethanol as solvent, then according to the appropriate solid-liquid ratio (1:10-1:40), in the multifunctional extraction tank, the circulation extraction (45-100℃, 1 hour) is carried out, the gauze is filtered, the membrane is concentrated, the freeze-drying is carried out to prepare the powder, and the saffron powder, green tea extract and chamomile powder are respectively obtained, or the mixture extract is directly prepared.

[0037] The composition formula of example 1-15 is shown in the table:

[0038] Table 1 composition formula

[0039]

[0040] Experimental example 1

[0041] The 6-day-old wild type AB zebrafish is selected, the pentyrazole is used to induce the sleepless model, the melatonin is used as a positive control, the concentration of the melatonin is set to 100 μM, the raw materials and results are shown in table 2, wherein, the green tea extract (EC50 is 45.4 μg·mL -1 ), the saffron powder (EC50 is 322.4 μg·mL -1 ) and the chamomile powder (EC50 is 160 μg·mL -1 ) are set according to the respective EC50 values; the dose of passion fruit extract is set to 200 μg·mL -1 , the dose of tryptophan is set to 30 μg·mL -1 , and the dose of jujube powder is set to 300 μg·mL -1 .

[0042] Before the behavior experiment starts, the pentyrazole solution is added in the water of each group, and the melatonin mother liquor and the treatment group mother liquor are timely dropped respectively, so that the dose meets the experimental setting dose.

[0043] The behavior analysis instrument is used to record the movement trajectory of zebrafish for 1 hour, and the movement speed is classified: less than 0.5 cm / s is slow, 0.5~2 cm / s is medium, and more than 2 cm / s is high. Within 1 hour, the slow movement lasting ≥6 seconds is recorded as a sleep, the total number of sleep is the number of sleep rounds, the sleep time is the sum of all sleep times, and the average sleep time is the average value of the total sleep time.

[0044] The sleep improvement rate calculation formula is as follows:

[0045] Sleep improvement rate = 100 x (total distance of high-speed movement of model group-total distance of high-speed movement of treatment group) / total distance of high-speed movement of model group.

[0046] Table 2 raw materials of sleep improvement composite formula based on zebrafish sleepless model

[0047]

[0048] Note: " / " means no value; statistical differences compared with the model group are marked as p <0.05, p <0.01, p <0.001; statistical differences compared with the control group are marked as p <0.05, p <0.01, p <0.001.

[0049] The present experimental example evaluates the improvement effect of 6 food raw materials (green tea extract, saffron powder, chamomile powder, passion fruit extract, tryptophan, and jujube powder) on the insomnia phenotype, and the ranking of each index is as follows:

[0050] Sleep improvement rate: green tea extract > chamomile powder > saffron powder > passion fruit extract > jujube powder > tryptophan;

[0051] Sleep round number: green tea extract > saffron powder > chamomile powder > jujube powder > passion fruit extract > tryptophan;

[0052] Sleep duration: saffron powder > chamomile powder > green tea extract > jujube powder > passion fruit extract > tryptophan.

[0053] The results show that green tea extract and chamomile powder can improve the sleep improvement rate, and the combination may have a synergistic effect, reducing the effective dosage; green tea extract and saffron powder significantly increase the sleep round number, and the combination may have a synergistic effect; saffron powder and chamomile powder significantly prolong the sleep duration, and the combination may have a synergistic effect.

[0054] Considering the improvement effect and contribution rate of each raw material, the present study selects green tea extract, chamomile powder, and saffron powder as the core raw materials for improving sleep composite formula. On the basis of verifying the combination effect of two raw materials, further combination with the third raw material is carried out to confirm the synergistic effect of the three raw materials.

[0055] Experimental Example 2

[0056] The experimental method is the same as that in Experimental Example 2, and the combination raw materials and results are shown in Table 3.

[0057] Table 3 Effect of Saffron Powder and Chamomile Compound on Zebrafish Sleep

[0058]

[0059] 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.

[0060] 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.

[0061] Experimental Example 3

[0062] The experimental method was the same as in Experiment 1. The compound raw materials and results are shown in Table 4.

[0063] Table 4. Effects of green tea extract and chamomile powder complex on sleep in zebrafish.

[0064]

[0065] 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.

[0066] 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 EC50values, three compound ratios were set in this study: 1:1, 10:1, and 1:10. The experimental results showed that the sleep improvement rates of the compounds were increased by 45.3% (1:1), 51.1% (10:1), and 58.3% (1:10), respectively, and the corresponding CI values were 0.52, 0.44, and 0.43, respectively, all of which were less than 1, indicating that the green tea extract and chamomile powder compound significantly improved the sleep improvement rate and exhibited a synergistic effect within the ratio range of 1:10 to 10:1. In addition, the sleep round times of the compounds were increased by 37.8% (1:1), 34.6% (10:1), and 36.5% (1:10), respectively, the total sleep times were increased by 53.4% (1:1), 55.6% (10:1), and 58.6% (1:10), respectively, and the average sleep times were increased by 11.6% (1:1), 15.8% (10:1), and 16.3% (1:10), respectively. These results further confirmed the significant improvement of the green tea extract and chamomile powder compound on the sleep quality of zebrafish. Within the compound ratio range of 1:10 to 10:1, the green tea extract and chamomile powder significantly improved the sleep improvement rate of zebrafish, increased the sleep round times, total sleep times, and average sleep times, and exhibited a synergistic effect, but there was still a certain gap compared with the positive control melatonin.

[0067] Experimental Example 4

[0068] The experimental method was the same as that in Experimental Example 1, and the compound raw materials and results are shown in Table 5.

[0069] Table 5 Effect of green tea extract and saffron powder compound on sleep of zebrafish

[0070]

[0071] Note: The dosage of Example 7, Example 8, and Example 9 was 50% effective dose; " / " indicates no numerical value; statistical difference compared with the model group is marked as * p <0.05,** p <0.01,*** p <0.001. <0.001.

[0072] Based on the data in Table 5, the sleep round times of zebrafish treated with green tea extract and saffron powder alone were increased by 31.4% and 28.9% respectively compared with the model group, showing the potential to improve sleep round times. Based on the EC50 values, three compound ratios were set in this study: 1:1, 7:1 and 1:7. The results showed that the improvement effect of the compound on sleep round times was 36.5% (1:1), 42.1% (7:1) and 47.8% (1:7) respectively, and the corresponding joint indexes were 0.82, 0.69 and 0.73 respectively, all less than 1, indicating that within the ratio range of 1:7 to 7:1, the compound of green tea extract and saffron powder had a synergistic effect on improving sleep round times. In addition, the sleep improvement rates of the compound were 50.3% (1:1), 57.2% (7:1) and 64.2% (1:7) respectively, the sleep duration was increased by 1.6 times (1:1), 1.7 times (7:1) and 1.8 times (1:7) respectively, and the average sleep duration was increased by 19.8% (1:1), 16.6% (7:1) and 19.3% (1:7) respectively. These results further confirmed the significant improvement effect of the compound of green tea extract and saffron on the sleep quality of zebrafish. Within the ratio range of 1:7 to 7:1, green tea extract and saffron powder significantly improved the sleep round times, sleep improvement rate, sleep duration and average sleep duration of zebrafish, and showed a synergistic effect, but there was still a certain gap compared with the positive control melatonin.

[0073] Experimental Example 5

[0074] The experimental method was the same as that in Experimental Example 1, and the compound raw materials and results are shown in Table 6.

[0075] Table 6 Effect of green tea extract, saffron powder and chamomile powder compound on sleep of zebrafish

[0076]

[0077] Note: The dosage of each example was 50% effective dose; " / " indicates no value; statistical difference compared with the model group is marked as * p <0.05,** p <0.01,*** p <0.001.

[0078] As shown in Table 6, the sleep improvement rates of zebrafish treated with green tea extract, saffron powder and chamomile powder alone were 48.5%, 26.3% and 37.1% respectively, and the sleep round times, sleep duration and average sleep duration were all significantly increased compared with the model group, showing the potential to improve sleep.

[0079] Based on the experimental results, the green tea extract, saffron powder and chamomile powder showed obvious synergy after being compounded with each other. In this study, the fixed ratio of compound powder was used for experiment: saffron and chamomile compound powder (20:1), green tea extract and chamomile compound powder (10:1), green tea extract and saffron compound powder (7:1). The results showed that the sleep improvement rate of compound powder was 40.2%, 47.5% and 53.7% respectively, and the CI value was 0.79, 0.74 and 0.69 respectively, all less than 1, indicating that the two two-compound powders had synergistic effect. In addition, the improvement effect of compound powder on sleep round number, sleep time and average sleep time was as follows: sleep round number increased by 33.8%, 36.3% and 36.9%; sleep time increased by 50.8%, 49.8% and 52.1%; average sleep time increased by 12.4%, 9.7% and 11.3%.

[0080] Further experiments showed that when saffron and chamomile compound powder (20:1) was compounded with green tea extract, the sleep round number increased by 39.4%, the sleep time increased by 60.9%, the average sleep time increased by 15.6%, the sleep improvement rate was 59.8%, and the CI value was 0.66 when compounded at a ratio of 10:1; the sleep round number increased by 41.3%, the sleep time increased by 63.3%, the average sleep time increased by 15.6%, the sleep improvement rate was 64.3%, and the CI value was 0.63 when compounded at a ratio of 1:10.

[0081] When green tea extract and chamomile compound powder (10:1) was compounded with saffron powder, the sleep round number increased by 42.5%, the sleep time increased by 75.0%, the average sleep time increased by 22.6%, the sleep improvement rate was 68.5%, and the CI value was 0.62 when compounded at a ratio of 10:1; the sleep round number increased by 44.4%, the sleep time increased by 80.4%, the average sleep time increased by 24.7%, the sleep improvement rate was 72.6%, and the CI value was 0.5 when compounded at a ratio of 1:10, and the improvement effect was equivalent to that of positive control melatonin.

[0082] When green tea extract and saffron compound powder (7:1) was compounded with chamomile powder, the sleep improvement rate was 75.6% and the CI value was 0.39 when compounded at a ratio of 10:1; the sleep round number increased by 45.6%, the sleep time increased by 84.7%, and the average sleep time increased by 26.9%; the sleep improvement rate was 78.1% and the CI value was 0.33 when compounded at a ratio of 1:10; the sleep round number increased by 46.9%, the sleep time increased by 87.7%, and the average sleep time increased by 27.4%. The CI value of all compound combinations was less than 1, indicating that the three compounds had significant synergy, and the improvement effect of green tea extract and saffron compound powder (7:1) compounded with chamomile powder at a ratio of 10:1 was better than that of positive control melatonin.

[0083] In summary, green tea extract, saffron powder and chamomile powder can significantly improve sleep when they are compounded in the ratio of 1:7 to 7:1, and the combination of the three has a better synergistic effect, which is comparable to the positive control melatonin.

[0084] Experimental Example 6

[0085] To determine the effects of green tea extract, saffron powder and chamomile powder compound on sleep phenotype and biochemical indicators, and to provide data support for subsequent product development, based on the compound formula and dose verified by zebrafish experiments, the dose was converted into mouse intake dose according to the dose conversion method of patent CN113496071A, and the effect of improving sleep was verified according to the standard method of "Health Care Product Function Test and Evaluation Method". The specific results are as follows:

[0086] Table 7 Effect of green tea extract, saffron powder and chamomile powder compound on sleep and related indicators of mice

[0087]

[0088] Note: " / " means no value; statistical difference compared with the model group is marked as * p <0.05,** p <0.01,*** p <0.001.

[0089] According to the data in Table 6, diazepam as a positive control can shorten the sleep latency of mice by 32.4%, increase the sleep duration by 78.6%, increase the 5-hydroxytryptamine level by 41.0%, increase the ratio of gamma-aminobutyric acid / glutamic acid by 20.0%, and reduce the glutamic acid level by 31.2%, indicating that it significantly improves the sleep phenotype of mice.

[0090] Saffron and chamomile compound powder (20:1) and green tea extract: 10:1 compound: sleep latency decreased by 13.9%, sleep duration increased by 27.8%, 5-hydroxytryptamine level increased by 12.7%, gamma-aminobutyric acid / glutamic acid ratio increased by 6.2%, and glutamic acid level decreased by 10.3%. 1:10 compound: sleep latency decreased by 20.2%, sleep duration increased by 24.1%, 5-hydroxytryptamine level increased by 15.5%, gamma-aminobutyric acid / glutamic acid ratio increased by 9.2%, and glutamic acid level decreased by 7.3%.

[0091] Green tea extract and chamomile compound powder (10:1) and saffron: 10:1 compound: sleep latency reduced by 22.2%, sleep duration increased by 35.6%, 5-hydroxytryptamine level increased by 20.6%, gamma-aminobutyric acid / glutamic acid ratio increased by 12.3%, and glutamic acid level decreased by 15.2%. 1:10 compound: sleep latency reduced by 23.8%, sleep duration increased by 38.4%, 5-hydroxytryptamine level increased by 25.8%, gamma-aminobutyric acid / glutamic acid ratio increased by 13.8%, and glutamic acid level decreased by 17.3%.

[0092] Green tea extract and chamomile compound powder (10:1) and saffron: 10:1 compound: sleep latency reduced by 22.2%, sleep duration increased by 35.6%, 5-hydroxytryptamine level increased by 20.6%, gamma-aminobutyric acid / glutamic acid ratio increased by 12.3%, and glutamic acid level decreased by 15.2%. 1:10 compound: sleep latency reduced by 23.8%, sleep duration increased by 38.4%, 5-hydroxytryptamine level increased by 25.8%, gamma-aminobutyric acid / glutamic acid ratio increased by 13.8%, and glutamic acid level decreased by 17.3%.

[0093] In summary, green tea extract, saffron and chamomile compound powder can significantly shorten sleep latency, increase sleep duration, improve mouse sleep by increasing 5-hydroxytryptamine level and gamma-aminobutyric acid / glutamic acid ratio, and reducing glutamic acid level. The formula of Example 15 is close to the effect of the positive control. According to the standard of "Health Food Function Test and Evaluation Method", the composition of the application has a significant sleep improvement effect.

[0094] Experimental Example 6

[0095] In this experiment, 65 volunteers were recruited from a unit work group, and their sleep quality was evaluated by 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 objects. No control group was set in the experiment, only the sleep improvement effect of the test population after continuous consumption of the pilot production beverage (formula: Example 15, green tea extract 21 mg, saffron powder 3 mg, chamomile powder 240 mg dissolved in 25 ml pure water, sterilized and packaged to provide to the volunteers, taken 10-30 minutes before sleep every day) for 7 days was tracked. A total of 30 valid questionnaires were returned, and the statistical results are as follows:

[0096] Table 8 Effect of Example 15 formula on sleep improvement and 7-day continuous sleep improvement in people

[0097]

[0098] As shown in Table 7, after taking the compound beverage of green tea extract, saffron powder and chamomile powder for 7 days, the sleep time of 86% of the subjects was shortened, the total sleep time of 88% of the subjects was prolonged, the sleep quality of 87% of the subjects was improved, and the mental state of 90% of the subjects after sleep was improved. The sleep data record for 7 consecutive days showed that as the taking time was prolonged, the sleep time, total sleep time, sleep quality and mental state after sleep of the subjects were continuously improved. The results showed that the compound beverage had a significant improvement effect on mild and moderate sleep disorders, and the effect was continuously good.

[0099] Comparative Example

[0100] The raw materials of the comparative example and the results are shown in Table 8, and the raw materials are all obtained by market purchase. The specific results are as follows:

[0101] Comparative Example 1

[0102] The components (parts by weight) in this scheme are: passion fruit extract 1 part, and jujube seed powder 8 parts.

[0103] Comparative Example 2

[0104] The components (parts by weight) in this scheme are: passion fruit extract 2 parts, and jujube seed powder 7 parts.

[0105] Comparative Example 3

[0106] The components (parts by weight) in this scheme are: passion fruit extract 8 parts, and jujube seed powder 1 part.

[0107] Comparative Example 4

[0108] The components (parts by weight) in this scheme are: passion fruit extract 8 parts, jujube seed powder 1 part and asparagus extract 1 part.

[0109] The above comparative examples were subjected to zebrafish experiments by referring to the method of Experimental Example 1, and the experimental results are as follows:

[0110] Table 9 Effect of comparative examples on zebrafish sleep

[0111]

[0112] As shown in Table 8, when passion fruit extract, jujube seed powder and asparagus extract were treated alone, the sleep time was increased by 20.9%, 23.9% and 4.6% respectively compared with the model group, and the corresponding sleep improvement rates were 18.4%, 21.3% and 4.2% respectively, indicating that these raw materials had sleep improvement effect when used alone. However, when combined in pairs or three, the sleep improvement rate increased, but the CI values were 1.44, 1.58, 1.66 and 1.82 respectively, all greater than 1, indicating that these combinations did not show a synergistic effect, and also indicating that the single raw material with sleep improvement effect did not necessarily produce a synergistic effect when combined.

[0113] The above-described embodiments are merely illustrative of several embodiments of the present application, which are described in more detail and in a specific manner, but should not be construed as limiting the scope of the patent. It should be noted that for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present application, and these are all within the scope of the present application. Therefore, the scope of protection of the patent of the present application should be subject to the appended claims.

Claims

1. A composition for improving sleep, characterized by, The saffron powder, chamomile powder and green tea extract are compounded; The saffron powder and chamomile powder are compounded at a weight ratio of 20:1, and then compounded with the green tea extract at a weight ratio of 10:1 to 1:10 of the total weight of the saffron powder and chamomile powder to the weight of the green tea extract; Or The green tea extract and chamomile powder are compounded at a weight ratio of 10:1, and then compounded with the saffron powder at a weight ratio of 10:1 to 1:10 of the total weight of the green tea extract and chamomile powder to the weight of the saffron powder; Or The green tea extract and saffron powder are compounded at a weight ratio of 7:1, and then compounded with the chamomile powder at a weight ratio of 10:1 to 1:10 of the total weight of the green tea extract and saffron powder to the weight of the chamomile powder. The mass percentage of crocin in the saffron powder is not less than 3.5%, the mass percentage of chamomile polysaccharide in the chamomile powder is not less than 5%, and the mass percentage of theanine in the green tea extract is not less than 20%.

2. The composition for improving sleep according to claim 1, wherein The saffron powder and chamomile powder are compounded at a weight ratio of 20:1, and then compounded with the green tea extract at a weight ratio of 10:1 or 1:10 of the total weight of the saffron powder and chamomile powder to the weight of the green tea extract.

3. The composition for improving sleep according to claim 1, wherein The green tea extract and chamomile powder are compounded at a weight ratio of 10:1, and then compounded with the saffron powder at a weight ratio of 10:1 or 1:10 of the total weight of the green tea extract and chamomile powder to the weight of the saffron powder.

4. The composition for improving sleep according to claim 1, wherein The green tea extract and saffron powder are compounded at a weight ratio of 7:1, and then compounded with the chamomile powder at a weight ratio of 10:1 or 1:10 of the total weight of the green tea extract and saffron powder to the weight of the chamomile powder.

5. Use of the composition according to any one of claims 1 to 4 in the preparation of a sleep improvement product.

6. Use according to claim 5, characterized in that, The sleep improvement product is a drug or a health food.

7. Use according to claim 6, characterized in that, The health food is a solid beverage, a pressed candy or an oral liquid.

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