Composition with sleep aiding and memory improving effects as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of development of health care products or medicines, and particularly relates to a composition with sleep-aiding and memory-improving effects as well as a preparation method and application of the composition. The composition is prepared from the following components in parts by weight: 6 to 15 parts of magnesium ion source, 2 to 6 parts of ferrous sulfate, 0.2 to 2 parts of vitamin B6, 0.8 to 6 parts of gamma-aminobutyric acid, 1 to 6 parts of L-theanine, 1 to 5 parts of urolithin A, 0.5 to 5 parts of fisetin and 2 to 8 parts of plant extract. The magnesium ion source compound is combined with the ferrous sulfate, the urolithin A, the fisetin and other active ingredients to prepare the composition with the sleep aiding and memory improving effects, the composition is screened according to a scientific formula, the sleep quality can be effectively improved, the memory can be improved, meanwhile, the composition has the anti-depression effect, and after the composition is taken, sleepiness and inattention do not occur. The traditional Chinese medicine composition ensures that a user can keep good vigor and state in daily life.

Description

Technical Field

[0001] The invention belongs to the technical field of health care product or medicine development, and in particular relates to a composition with the effects of aiding sleep and improving memory, and a preparation method and application thereof. Background Art

[0002] Sleep takes up a large part of life, and adequate sleep is essential for good mental or physical health. It can restore body functions, improve immunity, reduce the risk of cardiovascular disease, and promote metabolism and muscle recovery. Poor sleep quality can lead to adverse physical symptoms including fatigue, attention deficit, memory loss, depression, anxiety, etc. In addition, it increases the risk of heart and metabolic diseases, including obesity, diabetes and hypertension. Sleep quality is affected by many physiological, psychological and social factors. Diseases that may cause insomnia include psychological stress, chronic pain, heart failure, hyperthyroidism, heartburn, restless legs syndrome, menopause, etc. According to statistics from the World Health Organization, about one-third of people worldwide suffer from sleep problems. Among them, the problem of insufficient sleep is particularly prominent. A survey in 2019 showed that 40% of Japanese people sleep less than 6 hours; more than half of Australian teenagers do not get enough sleep; 62% of adults in Singapore believe that they do not get enough sleep. The survey results released by the China Sleep Research Society show that the incidence of insomnia among Chinese adults is as high as 38.2%, which means that more than 300 million Chinese people have sleep disorders, among which young people have more prominent sleep problems.

[0003] There are many ways to improve sleep quality, including taking medications and dietary supplements. Sleeping pills are usually divided into two categories: benzodiazepines (such as diazepam, alprazolam) and non-benzodiazepines (such as zopiclone, zolpidem), which can help people with insomnia fall asleep faster, but they will have side effects such as dizziness, fatigue, drowsiness, and lack of energy after waking up. In addition, drugs can make people dependent, and long-term use may affect sleep quality. Compared with drugs, dietary supplements are safer and have fewer side effects, but the efficacy of most sleep-aiding dietary supplements on the market is unclear. Most products simply combine ingredients with sleep-aiding effects, and have not studied the dosage of each ingredient and the synergistic effects of each ingredient. Their efficacy has not been verified, resulting in insufficient dosage and no effect, or excessive dosage and drowsiness, lack of concentration, and mental fatigue. Poor sleep quality is usually accompanied by symptoms such as memory loss, depression, anxiety, and emotional instability. Therefore, a product with clear sleep-aiding, memory-improving, and mood-regulating effects can better solve the pain points of people with insomnia. Summary of the invention

[0004] The purpose of the present invention is to overcome the shortcomings of the above-mentioned prior art and provide a composition with the effects of helping sleep and improving memory, as well as its preparation method and application, so as to effectively improve sleep quality and improve memory, and at the same time have anti-depressant effects. After taking it, there is no side effect of drowsiness, lack of concentration, and mental depression, and it has good safety, no dependence and tolerance.

[0005] To achieve the above objectives, the technical solutions adopted by the present invention include:

[0006] In a first aspect, the present invention provides a composition having the effects of aiding sleep and improving memory, the composition comprising the following components in parts by weight: 6-15 parts of a magnesium ion source, 2-6 parts of ferrous sulfate, 0.2-2 parts of vitamin B6, 0.8-6 parts of γ-aminobutyric acid, 1-6 parts of L-theanine, 1-5 parts of urolithin A, 0.5-5 parts of fisetin and 2-8 parts of a plant extract.

[0007] The present invention uses magnesium ion source compounds combined with active ingredients such as ferrous sulfate, urolithin A and fisetin to prepare a composition with the effects of helping sleep and improving memory. The composition is screened through a scientific formula and can effectively improve sleep quality and memory. It also has an anti-depressant effect. After taking it, there is no side effect of drowsiness, lack of concentration, and mental depression, ensuring that users maintain good energy and state in daily life. Compared with traditional sedative drugs, the composition of the present invention has higher safety, does not produce dependence and tolerance, and long-term use will not have a negative impact on the body.

[0008] In addition, the inventors have discovered through a large number of experiments and investigations that there is an obvious synergistic effect between the magnesium ion source compound, ferrous sulfate, urolithin A and fisetin active components in the composition. The cooperation of the four components can significantly enhance the sleep-inducing and memory-improving effects of the composition. When any one or more of the four components are missing, the sleep-inducing effect of the product will be weakened, and the memory-improving effect will also deteriorate.

[0009] In addition, the inventors explored the dosage of each component and found that when the dosage ratio of the above four active components exceeds the specified range of the present invention, the synergistic effect between the components is not obvious and even produces a certain antagonistic effect, which leads to a decrease in the sleep-inducing and memory-improving effects of the composition, indicating that the above four components have an ideal synergistic effect within the preferred range of the present invention.

[0010] Preferably, the composition comprises the following components in parts by weight: 8-11 parts of magnesium ion source, 3.5-4.5 parts of ferrous sulfate, 0.5-1.2 parts of vitamin B6, 1.2-3.5 parts of γ-aminobutyric acid, 2-4 parts of L-theanine, 2-4 parts of urolithin A, 0.8-3 parts of fisetin and 3-6 parts of plant extract.

[0011] Preferably, the composition comprises the following components in parts by weight: 10 parts of magnesium ion source, 4 parts of ferrous sulfate, 0.8 parts of vitamin B6, 1.5 parts of γ-aminobutyric acid, 2 parts of L-theanine, 2.5 parts of urolithin A, 1 part of fisetin and 4.2 parts of plant extract.

[0012] It has been found through experimental research that when the components of the present invention are combined in the optimal dosage ratio defined above, the prepared composition has the best effects of helping sleep and improving memory.

[0013] Preferably, the magnesium ion source includes at least one of magnesium bisglycinate, magnesium taurate, magnesium malate and magnesium threonate.

[0014] Preferably, the magnesium ion source is magnesium bisglycinate, magnesium taurate and magnesium malate.

[0015] Preferably, the mass ratio of magnesium bisglycinate, magnesium taurate and magnesium malate is (6-8):(1-2):(1-2).

[0016] More preferably, the mass ratio of the magnesium bisglycinate, magnesium taurate and magnesium malate is 8:1:1.

[0017] Through experimental exploration, it was found that when the above-defined magnesium ion source compound is compounded with other components, the composition can ensure that it has better sleep-aiding and memory-improving effects. When magnesium bisglycinate, magnesium taurine and magnesium malate are compounded as magnesium ion sources under the above-mentioned optimal ratio conditions, the sleep time of experimental mice can be extended to the greatest extent and their memory can be significantly improved, making the product have great potential in improving sleep quality and enhancing cognitive function.

[0018] Preferably, the plant extract comprises at least one of chamomile extract, ashwagandha extract, valerian extract, centella asiatica extract, ginkgo leaf extract and kava root extract.

[0019] Preferably, the plant extract is chamomile extract, ashwagandha extract and ginkgo leaf extract.

[0020] Preferably, the mass ratio of the chamomile extract, the ashwagandha extract and the ginkgo biloba extract is 2:1.2:1.

[0021] Chamomile extract contains active ingredients such as flavonoids, especially apigenin, which has a calming and relaxing effect on nerves, can help relieve anxiety and improve sleep quality; South African somnolence extract contains some specific compounds, such as flavonoids, which have a calming and hypnotic effect, can help relax nerves and relieve stress; Ginkgo biloba extract is rich in flavonoids, terpenes and other active chemicals, which have a strong antioxidant effect, can improve brain blood circulation, promote neuroprotection, and thus help improve cognitive function. It was found through experimental exploration that the present invention uses the above three components in a specific amount ratio range, and can form a complementary effect on the basis of their respective effects, further enhancing the dual improvement effect of magnesium ion source compounds and other active components on sleep and memory.

[0022] In a second aspect, the present invention provides use of the composition in preparing a product for aiding sleep or improving memory.

[0023] In a third aspect, the present invention provides a hard capsule having the effects of aiding sleep and improving memory, wherein the hard capsule comprises contents and a plant hard capsule shell, wherein the contents comprise the composition having the effects of aiding sleep and improving memory.

[0024] Preferably, the contents further include tricalcium phosphate, silicon dioxide and magnesium stearate, and the mass ratio of the tricalcium phosphate, silicon dioxide and magnesium stearate to the magnesium ion source in the composition having the effects of aiding sleep and improving memory is (0.1-0.25):(0.05-0.1):(0.05-0.08):1.

[0025] In a fourth aspect, the present invention provides a method for preparing the hard capsule having the effects of aiding sleep and improving memory, comprising the following steps:

[0026] S1. Weigh each component in the content respectively, pass each component through a 60-80 mesh sieve, and stir for 30-40 minutes to mix evenly to obtain the content;

[0027] S2, filling the contents into the plant hard capsule shell to obtain the hard capsule.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] The present invention uses magnesium ion source compounds combined with active ingredients such as ferrous sulfate, urolithin A and fisetin to prepare a composition with the effects of helping sleep and improving memory. The composition is screened through a scientific formula and can effectively improve sleep quality and memory. It also has an anti-depressant effect. After taking it, there is no side effect of drowsiness, lack of concentration, and mental depression, ensuring that users maintain good energy and state in daily life. Compared with traditional sedative drugs, the composition of the present invention has higher safety, does not produce dependence and tolerance, and long-term use will not have a negative impact on the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 This is an appearance diagram of the hard capsule prepared in Example 1 and its contents. DETAILED DESCRIPTION

[0031] To better illustrate the purpose, technical solutions and advantages of the present invention, the present invention will be further described below in conjunction with specific embodiments. It should be understood by those skilled in the art that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0032] Unless otherwise specified, all raw materials involved in the following examples and comparative examples are commercially available general raw materials.

[0033] Example 1

[0034] The present embodiment provides a hard capsule with the effects of helping sleep and improving memory, comprising the following components in parts by weight: 8 parts of magnesium bisglycinate, 1 part of magnesium taurine, 1 part of magnesium malate, 4 parts of ferrous sulfate, 0.8 parts of vitamin B6, 1.5 parts of γ-aminobutyric acid, 2 parts of L-theanine, 2.5 parts of urolithin A, 1 part of fisetin, 2 parts of chamomile extract, 1.2 parts of ashwagandha extract, 1 part of ginkgo leaf extract, 1.2 parts of tricalcium phosphate, 0.5 parts of silicon dioxide and 0.5 parts of magnesium stearate.

[0035] The preparation method of the hard capsule comprises the following steps:

[0036] S1. Weigh each component in the content respectively, pass each component through a 60-80 mesh sieve, and stir for 30-40 minutes to mix evenly to obtain the content;

[0037] S2, filling the contents into the plant hard capsule shell to obtain the hard capsule.

[0038] Example 2

[0039] The present embodiment provides a hard capsule with the effects of aiding sleep and improving memory, comprising the following components in parts by weight: 6 parts of magnesium bisglycinate, 2 parts of ferrous sulfate, 2 parts of vitamin B6, 6 parts of γ-aminobutyric acid, 6 parts of L-theanine, 1 part of urolithin A, 0.5 parts of fisetin, 2 parts of chamomile extract, 3 parts of ashwagandha extract, 2 parts of ginkgo leaf extract, 1 part of kava extract, 1.5 parts of tricalcium phosphate, 0.6 parts of silicon dioxide and 0.48 parts of magnesium stearate.

[0040] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0041] Example 3

[0042] The present embodiment provides a hard capsule with the effects of aiding sleep and improving memory, comprising the following components in parts by weight: 15 parts of magnesium bisglycinate, 6 parts of ferrous sulfate, 0.2 parts of vitamin B6, 0.8 parts of γ-aminobutyric acid, 1 part of L-theanine, 1 part of urolithin A, 0.5 parts of fisetin, 2 parts of chamomile extract, 1.5 parts of tricalcium phosphate, 0.75 parts of silicon dioxide and 0.75 parts of magnesium stearate.

[0043] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0044] Example 4

[0045] The present embodiment provides a hard capsule with the effects of aiding sleep and improving memory, comprising the following components in parts by weight: 8 parts of magnesium bisglycinate, 3.5 parts of ferrous sulfate, 1.2 parts of vitamin B6, 3.5 parts of γ-aminobutyric acid, 4 parts of L-theanine, 2 parts of urolithin A, 0.8 parts of fisetin, 2 parts of Centella asiatica extract, 1 part of kava extract, 1 part of tricalcium phosphate, 0.4 parts of silicon dioxide and 0.4 parts of magnesium stearate.

[0046] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0047] Example 5

[0048] The present embodiment provides a hard capsule with the effects of aiding sleep and improving memory, comprising the following components in parts by weight: 11 parts of magnesium bisglycinate, 4.5 parts of ferrous sulfate, 0.5 parts of vitamin B6, 1.2 parts of γ-aminobutyric acid, 2 parts of L-theanine, 4 parts of urolithin A, 3 parts of fisetin, 2 parts of ashwagandha extract, 2 parts of ginkgo leaf extract, 2 parts of kava extract, 1.5 parts of tricalcium phosphate, 0.55 parts of silicon dioxide and 0.55 parts of magnesium stearate.

[0049] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0050] Example 6

[0051] This embodiment provides a hard capsule with the effects of helping sleep and improving memory. The components thereof are different from those of Example 1 in that only magnesium bisglycinate is used as a magnesium ion source, the weight portion of magnesium bisglycinate is 10 parts, and the remaining components and amounts are the same as those of Example 1.

[0052] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0053] Example 7

[0054] This embodiment provides a hard capsule with the effects of helping sleep and improving memory. The components thereof are different from those of Example 1 in that 6 parts of magnesium bisglycinate, 2 parts of magnesium taurine and 2 parts of magnesium malate are used as magnesium ion sources, and the remaining components and amounts are the same as those of Example 1.

[0055] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0056] Example 8

[0057] This embodiment provides a hard capsule with the effects of helping sleep and improving memory. The components thereof are different from those of Example 1 in that 4 parts of magnesium bisglycinate, 3 parts of magnesium taurate and 3 parts of magnesium malate are used as magnesium ion sources, and the remaining components and amounts are the same as those of Example 1.

[0058] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0059] Example 9

[0060] This embodiment provides a hard capsule with the effects of helping sleep and improving memory. The components thereof are different from those of Example 1 in that 8 parts of magnesium bisglycinate and 2 parts of magnesium threonate are used as magnesium ion sources, and the remaining components and amounts are the same as those of Example 1.

[0061] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0062] Example 10

[0063] This embodiment provides a hard capsule with the effects of helping sleep and improving memory. The difference between its components and those of Example 1 is that 2 parts of chamomile extract, 1.2 parts of valerian extract and 1 part of Centella asiatica extract are used as plant extracts, and the remaining components and amounts are the same as those of Example 1.

[0064] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0065] Comparative Example 1

[0066] This comparative example provides a hard capsule with the effects of helping sleep and improving memory. The components of the hard capsule are different from those of Example 1 in that the magnesium ion source compound is different, and an equal amount of magnesium oxide is used as the magnesium ion source to replace the magnesium bisglycinate, magnesium taurine and magnesium malate in Example 1. The remaining components and amounts are the same as those in Example 1.

[0067] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0068] Comparative Example 2

[0069] This comparative example provides a hard capsule with the effects of aiding sleep and improving memory. The components of the hard capsule differ from those of Example 1 in that it does not contain urolithin A and fisetin components, and the weight parts of magnesium bisglycinate, magnesium taurine, magnesium malate, and ferrous sulfate in the magnesium ion source are 8 parts, 2 parts, and 2 parts, respectively, and the weight parts are 5.5 parts, while the total weight parts of this comparative example and Example 1 are kept the same.

[0070] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0071] Comparative Example 3

[0072] This comparative example provides a hard capsule with the effects of aiding sleep and improving memory. The components thereof differ from those of Example 1 in that: it does not contain a ferrous sulfate component, and the weight portion of urolithin A is 4.5 parts, the weight portion of fisetin is 3 parts, and the total weight portion of this comparative example is kept the same as that of Example 1.

[0073] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0074] Comparative Example 4

[0075] This comparative example provides a hard capsule with the effects of aiding sleep and improving memory. The difference between its components and those of Example 1 is that an equal amount of maltodextrin is used to replace the magnesium ion source in Example 1, that is, this comparative example does not contain a magnesium ion source component, and the remaining components and amounts are the same as those in Example 1.

[0076] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0077] Comparative Example 5

[0078] This comparative example provides a hard capsule with the effects of helping sleep and improving memory. The components thereof are different from those of Example 1 in that the hard capsule does not contain γ-aminobutyric acid and L-theanine components, and an equal amount of maltodextrin is used to replace the γ-aminobutyric acid and L-theanine in Example 1. The remaining components and amounts are the same as those in Example 1.

[0079] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0080] Comparative Example 6

[0081] This comparative example provides a hard capsule with the effects of aiding sleep and improving memory. The difference between this comparative example and Example 1 is that the weight portions of the magnesium ion source, ferrous sulfate, urolithin A and fisetin are different, namely 2.7 parts of magnesium bisglycinate, 0.35 parts of magnesium taurine, 0.35 parts of magnesium malate, 8 parts of ferrous sulfate, 6 parts of urolithin A and 0.1 parts of fisetin, while the total weight portions of this comparative example and Example 1 are kept the same.

[0082] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0083] Comparative Example 7

[0084] This comparative example provides a hard capsule with the effects of aiding sleep and improving memory. The difference between this comparative example and Example 1 is that the weight portions of the magnesium ion source, ferrous sulfate, urolithin A and fisetin are different, namely 12.8 parts of magnesium bisglycinate, 1.6 parts of magnesium taurine, 1.6 parts of magnesium malate, 1 part of ferrous sulfate, 0.45 parts of urolithin A and 0.05 parts of fisetin, while the total weight portions of this comparative example and Example 1 are kept the same.

[0085] The preparation method of the hard capsule is similar to that of Example 1, except that the formula is different.

[0086] Effect Example 1

[0087] This effect example uses an animal evaluation test of the auxiliary sleep function to test the sleep-aiding effect of the sample. The specific method is as follows:

[0088] 1. Sample: The hard capsules prepared in Examples 1-10 and Comparative Examples 1-7 are recommended to be taken by humans at a dosage of 4 capsules / day (2800 mg / day), and the body weight is calculated as 60 kg, and the equivalent dosage is 0.047 g / kg.bw; the contents of the hard capsules are taken for testing.

[0089] 2. Experimental animals: SPF grade Kunming mice, weighing 18-22 g.

[0090] 3. Administration method: The dosage is 10 times the recommended human dose (0.47 g / kg.bw). When preparing the test solution, take 9.4 g of the hard capsule content, add pure water to dissolve and make up to 200 ml. The test group is given the corresponding test sample by oral gavage, and the gavage volume is 0.1 ml / 10 g.bw. The blank control group is given the same dose of distilled water.

[0091] 4. Specific experimental methods:

[0092] 1) Direct sleep experiment: 180 healthy male mice were taken and randomly divided into a test group and a blank control group, with 10 mice in each group. The test group was gavaged with the test solution prepared with the contents of the hard capsules described in Examples 1-10 and Comparative Examples 1-7. Once a day for 30 consecutive days, after the last administration, observe whether the animals show signs of sleep. Sleep is indexed by the disappearance of the righting reflex. When the mouse is placed in a dorsal position, it can turn right immediately. If it cannot turn right for more than 30-60 seconds, it is considered that the righting reflex has disappeared and it has entered sleep. The recovery of the righting reflex means that the animal has awakened, and the period from the disappearance of the righting reflex to the recovery is the animal's sleep time. The number of sleeping animals and the sleep time of the blank control group and the test sample group were recorded. The results are shown in Table 1.

[0093] 2) Experiment on prolonging the sleeping time of sodium pentobarbital: 180 healthy male mice were randomly divided into a test group and a blank control group, with 10 mice in each group. The test group was gavaged with the test solution prepared by the contents of the hard capsules described in Examples 1-10 and Comparative Examples 1-7. Once a day for 30 consecutive days, 30 minutes after the last administration, each group of animals was intraperitoneally injected with sodium pentobarbital 40 mg / kg.bw, with an injection volume of 0.2 mL / 20 g. The disappearance of the righting reflex was used as an indicator to observe whether the test sample could prolong the sleeping time of sodium pentobarbital. The results are shown in Table 1.

[0094] 3) Sodium barbital sleep latency experiment: 180 healthy male mice were randomly divided into a test group and a blank control group, with 10 mice in each group. The test group was gavaged with the test solution prepared by the contents of the hard capsules described in Examples 1-10 and Comparative Examples 1-7. Once a day for 30 consecutive days, 15 minutes after the last administration, each group of animals was intraperitoneally injected with 250 mg / kg.bw of sodium barbital, with an injection volume of 0.2 mL / 20 g. The disappearance of the righting reflex was used as an indicator to observe the effect of the test sample on the sodium barbital sleep latency. The results are shown in Table 1.

[0095] 5. Data statistics: SPSS statistical software was used to perform statistical processing and analysis on the data obtained in this study. The measurement data were expressed as mean ± standard deviation and the t test was used. The counting data were tested using the chi-square test. When P < 0.05, the difference was considered to be significant and statistically significant.

[0096] 6. Experimental results: As shown in Table 1, compared with the blank control group, the compositions described in Examples 1-10 can prolong the sleep time of sodium pentobarbital and the sleep latency time of sodium pentobarbital, with very significant differences (P < 0.01), especially the composition described in Example 1 has the best sleep-aiding effect; while in Comparative Example 1, the magnesium ion source compound selected by the present invention is replaced by other conventional magnesium ion sources, and in Comparative Examples 2-4, any one or two of the active components of urolithin A, fisetin, ferrous sulfate and magnesium ion source of the present invention are missing, respectively, the prepared compositions have the best effects on prolonging the sleep time of sodium pentobarbital and The sleep latency time of sodium barbital is significantly decreased compared with that in the embodiment, that is, the sleep-aiding effect of the composition is significantly deteriorated. When the dosage ratio of the above four active components in Comparative Examples 6-7 exceeds the specified range of the present invention, the sleep-aiding effect of the composition is also significantly deteriorated. The above results show that the active components of urolithin A, fisetin, ferrous sulfate and a specific magnesium ion source are compounded within the preferred range of the present invention. The four components cooperate with each other and can play a synergistic role, thereby significantly enhancing the sleep-aiding effect of the composition. The four components are indispensable, and the presence of γ-aminobutyric acid and L-theanine can further assist the sleep-improving effect of the active components.

[0097] Table 1

[0098]

[0099]

[0100] Note: Compared with the control group *P<0.05, **P<0.01

[0101] Effect Example 2

[0102] This effect example uses an animal evaluation experiment to assist in improving memory function to test the memory improvement effect of the sample. The specific method is as follows:

[0103] 1. Sample: The hard capsules prepared in Examples 1-10 and Comparative Examples 1-7 are recommended to be taken by humans at a dosage of 4 capsules / day (2800 mg / day), and the body weight is 60 kg, so the equivalent dosage is 0.047 g / kg.bw. The contents of the hard capsules are taken for testing.

[0104] 2. Experimental animals: SPF grade Kunming mice, weighing 18-22 g.

[0105] 3. Administration method: The dosage is 10 times the recommended human dose (0.47 g / kg.bw). When preparing the test solution, take 9.4 g of the hard capsule content, add pure water to dissolve and make up to 200 ml. The test group is given the corresponding test sample by oral gavage, and the gavage volume is 0.1 ml / 10 g.bw. The blank control group is given the same dose of distilled water.

[0106] 4. Experimental methods:

[0107] Water maze test: 180 male mice were randomly divided into a test group and a control group, with 10 mice in each group. The water maze test was started 30 days after the test substance was given. The test substance was continued to be given during the training period. Training was performed once a day for 5 consecutive days. Before the first day of training, the mice were placed near the ladder and allowed to climb up automatically 3 times. Before each subsequent training, the mice were placed near the ladder and allowed to climb up automatically once. On the first day of training, a baffle was used to block point A, and training was started from point A; on the second day, it started from point B, and this route was trained for 3 days until 80% of the animals reached the end point within 2 minutes; training started from the starting point on the fifth day; and finally the total learning performance of 5 days was evaluated. Extinction test was performed 5 days after stopping training.

[0108] 5. Experimental data statistics: SPSS statistical software was used to perform statistical processing and analysis on the data obtained in this study. The measurement data were expressed as mean ± standard deviation and the t test was used. The counting data were tested using the chi-square test. When P < 0.05, the difference was considered to be significant and statistically significant.

[0109] 6. Experimental results: As shown in Table 2, the time to reach the end point and the number of errors before reaching the end point of the mice taking the composition described in Examples 1-10 were significantly different from those of the blank control group. The above experimental results show that the composition prepared by the technical solution of the present invention has an effective function of improving memory. In the comparative examples, due to the lack of the limited components in the present invention or the amount of the components exceeding the preferred range of the present invention, the memory improvement effect of the prepared composition decreased.

[0110] Table 2

[0111]

[0112] Note: Compared with the control group *P<0.05, **P<0.01

[0113] Effect Example 3

[0114] This effect example uses an experiment to improve the depressive-like behavior of mice caused by sleep deprivation to test the antidepressant effect of the sample. The specific method is as follows:

[0115] 1. Sample: The hard capsules prepared in Examples 1-5 are recommended to be taken by humans at a dosage of 4 capsules / day (2800 mg / day), and the body weight is 60 kg, so the equivalent dosage is 0.047 g / kg.bw. The contents of the hard capsules are taken for testing.

[0116] 2. Experimental animals: SPF grade Kunming mice, weighing 18-22 g.

[0117] 3. Administration method: The dosage is 10 times the recommended human dose (0.47 g / kg.bw). When preparing the test solution, take 9.4 g of the hard capsule content, add pure water to dissolve and make up to 200 ml. The test group is given the corresponding test sample by oral gavage every day, and the gavage volume is 0.1 ml / 10 g.bw. The blank and model control groups are given the same dose of distilled water every day.

[0118] 4. Experimental methods:

[0119] 1) Establishment of sleep deprivation model: The sleep deprivation model was established using the classic modified multi-platform method. 70 mice were divided into 7 groups, namely, blank group, model control group, and experimental group, with 10 mice in each group. During the sleep deprivation process, the mice in the sleep deprivation group were placed on a small platform from 18:00 to 14:00 the next day for 5 consecutive days to ensure that they were awake for 20 consecutive hours; at the same time, the mice in the control group were placed in a mouse cage and raised normally. Five mice were placed in each sleep deprivation box, and all mice were free to drink water and eat. During the experiment, the temperature, humidity, and water temperature in the water tank were kept appropriate and consistent, and the water quality was clean.

[0120] 2) Mouse tail suspension experiment: Before the experiment, tape was wrapped around the tip of the mouse's tail about 1 cm away, and the mouse was hung upside down on an iron hook. It was first allowed to adapt for 2 minutes, and then the system automatically recorded the time the mouse was immobile within 4 minutes.

[0121] 3) Mouse forced swimming test: The experiment was conducted on the second day after the tail suspension experiment, and the test was performed 1 hour after the drug administration on the same day. After debugging the treatment system, the mice were placed in a constant temperature swimming apparatus and the system recorded the immobility time of the mice within 4 minutes.

[0122] 5. Experimental data statistics: SPSS statistical software was used to perform statistical processing and analysis on the data obtained in this study. The measurement data were expressed as mean ± standard deviation and the t test was used. The counting data were tested using the chi-square test. When P < 0.05, the difference was considered to be significant and statistically significant.

[0123] 6. Experimental results: As shown in Table 3, the immobility time of the mice in the sleep deprivation control group in the tail suspension test and the forced swimming test was significantly different from that of the blank control group (P < 0.01), indicating that the sleep deprivation mice developed depression symptoms during the modeling period; the immobility time of the mice in Examples 1-5 in the tail suspension test and the forced swimming test was significantly different from that of the model control group (P < 0.01), indicating that the contents of the hard capsules in Examples 1-5 can effectively improve the depressive state of mice.

[0124] Table 3

[0125]

[0126]

[0127] Note: Compared with the model control group *P<0.05, **P<0.01; compared with the blank control group #P<0.05, ##P<0.01 Effect Example 4

[0128] This effect example uses toxicological safety animal tests to test the cytotoxicity of the samples. The specific method is as follows:

[0129] 1. Sample: The hard capsules prepared in Examples 1-10 are recommended to be taken by humans at a dosage of 4 capsules / day (2800 mg / day), and the body weight is 60 kg, so the equivalent dosage is 0.047 g / kg.bw. The contents of the hard capsules were taken for testing.

[0130] 2. Experimental animals: SPF grade Kunming mice, weighing 18-22 g.

[0131] 3. Preparation of test samples: Take 10 g of the contents of the hard capsule, dissolve it in pure water and make up to 15 ml to prepare a test sample with a concentration of 0.67 g / mL.

[0132] 4. Experimental methods: Acute toxicity test in mice: The maximum tolerated dose method was used, and 40 Kunming mice weighing 18g-22g were selected. Half of them were male and half were female. The mice were orally gavaged with the test sample once, with a gavage volume of 0.2ml / 10g.bw, equivalent to a dose of 13.33g / kg.bw. They were fasted for 16 hours before gavage, and observed for 2 weeks after gavage, and the symptoms of poisoning and death were recorded.

[0133] 5. Experimental data statistics: SPSS statistical software was used to perform statistical processing and analysis on the data obtained in this study. The measurement data were expressed as mean ± standard deviation and the t test was used. The counting data were tested using the chi-square test. When P < 0.05, the difference was considered to be significant and statistically significant.

[0134] 6. Experimental results: As shown in Table 4, after gavage of the contents of the hard capsule at a dose of 13.33 g / kg.bw to Kunming mice of both sexes, no obvious symptoms of poisoning were observed, and no death was observed for 14 days. At the end of the observation period, the test animals were killed and anatomical examinations were performed, and no obvious abnormal changes were observed in the main organs such as the liver, spleen, kidney, stomach, intestines, heart, and lungs. It is thus judged that the hard capsule prepared by the technical solution of the present invention belongs to the non-toxic grade.

[0135] Table 4

[0136] gender Number of animals Number of deaths (individuals) MTD(g / kg.bw) male 20 0 ＞13.33 female 20 0 ＞13.33

[0137] Effect Example 5

[0138] This effect example uses the hard capsule prepared in Example 1 as a sample to test its stability. Test sample specifications: 0.7g / capsule, 120 capsules / bottle; stability test conditions: temperature: 37℃±1℃, humidity: 75%±2%; test items: vitamin B6, urolithin A, fisetin. The specific results are described in Table 5.

[0139] Table 5

[0140]

[0141] The stability test results are shown in Table 5. Under high temperature and high humidity conditions, after 3 months, the content state and the content of the characteristic components of the hard capsule described in Example 1 were within the quality control range without obvious loss, and it was determined to be a qualified product.

[0142] Finally, it should be noted that the above embodiments are intended to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention may be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. A composition having the effects of aiding sleep and improving memory, characterized in that: The composition comprises the following components in parts by weight: 6-15 parts of a magnesium ion source, 2-6 parts of ferrous sulfate, 0.2-2 parts of vitamin B6, 0.8-6 parts of gamma-aminobutyric acid, 1-6 parts of L-theanine, 1-5 parts of urolithin A, 0.5-5 parts of fisetin, and 2-8 parts of a plant extract; The magnesium ion source is at least one of magnesium bisglycinate, magnesium taurine, magnesium malate and magnesium threonate.

2. The composition according to claim 1, characterized in that The composition comprises the following components in parts by weight: 8-11 parts of magnesium ion source, 3.5-4.5 parts of ferrous sulfate, 0.5-1.2 parts of vitamin B6, 1.2-3.5 parts of γ-aminobutyric acid, 2-4 parts of L-theanine, 2-4 parts of urolithin A, 0.8-3 parts of fisetin and 3-6 parts of plant extract.

3. The composition according to claim 2, characterized in that The composition comprises the following components in parts by weight: 10 parts of magnesium ion source, 4 parts of ferrous sulfate, 0.8 parts of vitamin B6, 1.5 parts of gamma-aminobutyric acid, 2 parts of L-theanine, 2.5 parts of urolithin A, 1 part of fisetin and 4.2 parts of plant extract.

4. The composition according to claim 1, characterized in that The magnesium ion source is magnesium bisglycinate, magnesium taurine and magnesium malate.

5. The composition according to claim 4, characterized in that The mass ratio of magnesium bisglycinate, magnesium taurine and magnesium malate is (6-8):(1-2):(1-2).

6. The composition according to any one of claims 1 to 3, characterized in that The plant extract comprises at least one of chamomile extract, ashwagandha extract, valerian extract, centella asiatica extract, ginkgo leaf extract and kava root extract.

7. Use of the composition according to any one of claims 1 to 6 in preparing a product for aiding sleep or improving memory.

8. A hard capsule having the effects of helping sleep and improving memory, characterized in that: The hard capsule comprises contents and a plant hard capsule shell, wherein the contents comprise the composition having the effects of aiding sleep and improving memory according to any one of claims 1 to 6.

9. The hard capsule according to claim 8, characterized in that The contents also include tricalcium phosphate, silicon dioxide and magnesium stearate, and the mass ratio of the tricalcium phosphate, silicon dioxide and magnesium stearate to the magnesium ion source in the composition having the effects of aiding sleep and improving memory is (0.1-0.25): (0.05-0.1): (0.05-0.08):

1.

10. The method for preparing the hard capsule having the functions of helping sleep and improving memory according to claim 8 or 9, characterized in that: The following steps are involved: S1. Weigh each component in the content respectively, pass each component through a 60-80 mesh sieve, and stir for 30-40 minutes to mix evenly to obtain the content; S2, filling the contents into the plant hard capsule shell to obtain the hard capsule.

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