Composition with efficacy of improving sleep quality during pregnancy and application thereof

Abstract

The invention relates to a composition with an effect of improving sleep quality during pregnancy and application of the composition. The composition comprises aminobutyric acid, tea leaf theanine, casein hydrolysate and spearmint extract. The aminobutyric acid, the tea theanine, the casein hydrolysate and the spearmint extract are compounded for use, so that the problem that a single-mechanism sleep-aiding product has a limited effect on insomnia during pregnancy is solved, the sleep structure is improved to a great extent, and the sleep quality is improved.

Description

A composition with the effect of improving sleep quality during pregnancy and its application Technical Field

[0001] This invention belongs to the field of functional food technology, specifically relating to a composition that improves sleep quality during pregnancy and its application. Background Technology

[0002] Sleep disorders during pregnancy refer to disturbances in sleep patterns and behaviors that occur during pregnancy. These primarily include insomnia, nighttime awakenings, parasomnias (mainly restless legs syndrome and snoring), and hypersomnia. Current research has found that most pregnant women experience changes in their sleep structure during pregnancy, mainly manifested as increased insomnia and decreased daytime alertness. Sleep disorders in pregnant women are caused by physiological and anatomical changes, including urinary frequency, nausea, vomiting, fetal movement, and pain. Furthermore, hormonal changes during pregnancy are also a contributing factor to insomnia. Estrogen and progesterone affect sleep by acting on smooth muscle, the respiratory system, and the nervous system, primarily influencing the sleep-wake cycle.

[0003] Currently, there are numerous products and solutions on the market aimed at improving sleep, but most are common sedative medications. These medications often contain melatonin, valerian root extract, and other sleep-aiding ingredients that are contraindicated for pregnant women. Furthermore, while single-ingredient supplements such as butyric acid gummies and magnesium supplements are generally safer, they cannot comprehensively improve sleep quality in pregnant women.

[0004] Therefore, developing a safe composition that synergistically improves sleep quality during pregnancy through multiple mechanisms has become one of the urgent technical problems to be solved. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the purpose of this invention is to provide a composition and its application that improves sleep quality during pregnancy.

[0006] To achieve this objective, the present invention adopts the following technical solution:

[0007] In a first aspect, the present invention provides a composition that improves sleep quality during pregnancy, the composition comprising aminobutyric acid, tea theanine, casein hydrolysate, and spearmint extract.

[0008] As a major inhibitory neurotransmitter in the central nervous system, GABA can act on the central nervous system through the gut-brain axis and brain tissue transport proteins, shortening sleep latency, increasing non-rapid eye movement (NREM) sleep time, and inhibiting nerve excitation (reducing β waves and increasing α waves). It is also highly safe and non-addictive. Theanine in tea can upregulate the expression of GABA receptors in the brain, while reducing anxiety-related nerve signal transmission and prolonging sleep duration. It also has no sedative side effects, avoiding the risk of excessive central nervous system inhibition during pregnancy. Casein hydrolysate can reduce the release of stress hormones by regulating the gut microbiota-gut-brain axis, while enhancing GABAergic nerve conduction, thus alleviating sleep interruptions caused by hormonal fluctuations and physical burden during pregnancy. Spearmint extract can reduce the interference of oxidative stress on the nervous system during pregnancy and can also relieve mood swings.

[0009] This invention creatively discovers that the combination of GABA, tea theanine, casein hydrolysate, and spearmint extract has a significant synergistic effect in improving sleep quality and prolonging nighttime sleep time and deep sleep time.

[0010] Preferably, the aminobutyric acid includes γ-aminobutyric acid.

[0011] Preferably, the composition comprises, by weight parts, 1.2-2 parts of GABA, 1-1.5 parts of tea theanine, 1-3 parts of casein hydrolysate and 1-2 parts of spearmint extract.

[0012] Specifically, the specific point values ​​for 1.2-2 parts can be 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, etc.; the specific point values ​​for 1-1.5 parts can be 1, 1.1, 1.2, 1.3, 1.4, 1.5, etc.; the specific point values ​​for 1-3 parts can be 1, 1.3, 1.6, 1.9, 2.2, 2.5, 2.8, 3, etc.; and the specific point values ​​for 1-2 parts can be 1, 1.2, 1.4, 1.6, 1.8, 2, etc.

[0013] Preferably, the casein hydrolysate is prepared using a method comprising the following steps:

[0014] (1) Mix casein raw material with water and microwave it. After microwave treatment, filter and collect the filtrate to obtain pretreated solution.

[0015] (2) The pretreatment solution is mixed with the compound enzyme and enzymatic hydrolysis is carried out to obtain the enzymatic hydrolysate. The enzymatic hydrolysate is filtered and the filtrate is collected to obtain casein hydrolysate.

[0016] In the preparation of casein hydrolysate, this invention first microwaves the casein raw material and then enzymatically hydrolyzes the microwave-treated product, which can better hydrolyze the casein and the resulting mixture of small molecule peptides has a better effect on improving sleep quality.

[0017] Preferably, the ratio of casein raw material to water in step (1) is 1:10-1:30 g / mL, for example, it can be 1:10 g / mL, 1:15 g / mL, 1:20 g / mL, 1:25 g / mL, 1:30 g / mL, etc.

[0018] Preferably, the power of the microwave treatment in step (1) is 100-300 W (e.g., 100 W, 150 W, 200 W, 250 W, 300 W, etc.), and the microwave treatment time is 10-30 min (e.g., 10 min, 15 min, 20 min, 25 min, 30 min, etc.).

[0019] Preferably, the complex enzyme in step (2) includes papain, aminopeptidase and trypsin.

[0020] Papain is a cysteine ​​protease that can hydrolyze a variety of protein substrates. It has relatively broad specificity for peptide bonds and tends to break peptide bonds between amino acids such as arginine, lysine, phenylalanine, and tyrosine. Aminopeptidase is an enzyme that catalyzes the cleavage of amino acids from the amino terminus of proteins or peptide substrates. It achieves protein hydrolysis by selectively hydrolyzing the N-terminal amino acid residues of proteins and polypeptides. Trypsin is a serine protease that can hydrolyze peptide bonds at the carboxyl terminus of basic amino acids such as lysine and arginine in proteins.

[0021] This invention creatively discovers that the combined use of papain, aminopeptidase, and trypsin to enzymatically hydrolyze the product of microwave treatment of casein can better retain the functional components of casein that improve sleep quality during pregnancy, while also being highly compatible with other components in the composition such as GABA, tea theanine, and spearmint.

[0022] Preferably, the mass ratio of papain, aminopeptidase and trypsin is (1-5):(1-5):(1-5).

[0023] Among them, the specific point values ​​in 1-5 can be selected as 1, 2, 3, 4, 5, etc.

[0024] Preferably, the mass percentage of the complex enzyme in the pretreatment solution is 1-5% (e.g., 1%, 2%, 3%, 4%, 5%, etc.).

[0025] Preferably, the temperature of the enzymatic hydrolysis reaction is 45-55℃ (e.g., 45℃, 47℃, 49℃, 51℃, 53℃, 55℃, etc.), and the time of the enzymatic hydrolysis reaction is 1-3 h (e.g., 1 h, 1.5 h, 2 h, 2.5 h, 3 h, etc.).

[0026] Preferably, the spearmint extract is prepared by a method comprising the following steps:

[0027] Spearmint raw material was mixed with water and subjected to microjet extraction to obtain spearmint extract; the spearmint extract was filtered, the filtrate was collected and dried to obtain spearmint extract;

[0028] Preferably, the ratio of spearmint raw material to water is 1:5 to 1:20 g / mL (e.g., 1:5 g / mL, 1:10 g / mL, 1:15 g / mL, 1:20 g / mL, etc.).

[0029] This invention utilizes microfluidic extraction to better extract the active ingredients from spearmint, thereby enhancing the sleep-improving effect of spearmint extract.

[0030] Preferably, the pressure of the microjet extraction is 100-200 MPa (e.g., 100 MPa, 120 MPa, 140 MPa, 160 MPa, 180 MPa, 200 MPa, etc.), the temperature of the microjet extraction is 20-40℃ (e.g., 20℃, 25℃, 30℃, 35℃, 40℃, etc.), and the number of material circulations in the microjet extraction is 3-6 times (e.g., 3 times, 5 times, or 6 times).

[0031] Preferably, the composition further includes plant-derived components.

[0032] The plant-derived components include any one or a combination of at least two of lily, lotus seed or pistachio, preferably a combination of lily, lotus seed and pistachio.

[0033] Lily contains lily saponins, polysaccharides, and other components, which have a clear sedative and hypnotic effect. It can prolong the sleep time induced by sodium pentobarbital, shorten the sleep latency, and regulate the level of serotonin in the brain, thus relieving irritability during pregnancy. The core active ingredients of lotus seeds can calm the mind and soothe the nerves, and improve "restlessness and insomnia" during pregnancy by regulating the balance of neurotransmitters in the central nervous system. Pistachios contain natural melatonin, which can directly regulate the sleep rhythm center of the suprachiasmatic nucleus of the hypothalamus, supplement the insufficient melatonin secretion during pregnancy, and help establish a regular sleep-wake cycle.

[0034] This invention has found that the above-mentioned plant-derived components can further regulate the sleep-wake cycle and improve the sleep quality of pregnant women; and that lily, lotus seed and pistachio have a significant synergistic effect in prolonging nighttime sleep time and deep sleep time.

[0035] In this invention, lily is added to the composition in the form of fleshy scale leaf powder, lotus seed is added to the composition in the form of mature lotus seed powder, and pistachio is added to the composition in the form of pistachio kernel powder.

[0036] Preferably, the mass ratio of lily bulbs, lotus seeds and pistachios is (1-3):(1-3):(1-3).

[0037] Among them, the specific point values ​​in 1-3 can be selected as 1, 1.5, 2, 2.5, 3, etc.

[0038] Preferably, the composition further includes vitamin B6 and / or magnesium gluconate.

[0039] Vitamin B6 promotes neurotransmitter synthesis and reduces anxiety during pregnancy, preventing a vicious cycle of tension and insomnia. Magnesium gluconate relieves muscle tension and reduces nerve excitability during pregnancy. Both components are essential nutrients for pregnancy and are highly safe. This invention, by adding vitamin B6 and / or magnesium gluconate to the composition, further enhances the overall effect of the composition on improving sleep quality.

[0040] Preferably, the composition includes GABA, tea theanine, casein hydrolysate, spearmint extract, lily, lotus seed, pistachio, vitamin B6, and magnesium gluconate.

[0041] Preferably, the composition comprises, by weight parts, 1.2-2 parts of GABA, 1-1.5 parts of tea theanine, 1-3 parts of casein hydrolysate, 1-2 parts of spearmint extract, 0.01-0.03 parts of lily, 0.01-0.03 parts of lotus seed, 0.01-0.03 parts of pistachio, 0.0001-0.0002 parts of vitamin B6, and 0.06-0.08 parts of magnesium gluconate.

[0042] Specifically, for the 1.2-2 parts, the specific point values ​​can be 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2 parts, etc.; for the 1-1.5 parts, the specific point values ​​can be 1, 1.1, 1.2, 1.3, 1.4, or 1.5 parts, etc.; for the 1-3 parts, the specific point values ​​can be 1, 1.3, 1.6, 1.9, 2.2, 2.5, 2.8, or 3 parts, etc.; and for the 1-2 parts, the specific point values ​​can be 1, 1.2, 1.4, or 1... For 0.01-0.03 parts, specific point values ​​can be selected as 0.01, 0.015, 0.02, 0.025, 0.03 parts, etc. For 0.0001-0.0002 parts, specific point values ​​can be selected as 0.0001, 0.00013, 0.00016, 0.00019, 0.0002 parts, etc. For 0.06-0.08 parts, specific point values ​​can be selected as 0.06, 0.065, 0.07, 0.075, 0.08 parts, etc.

[0043] In a second aspect, the present invention provides a liquid beverage comprising water and the composition described in the first aspect.

[0044] Preferably, in the liquid beverage, the composition of the first aspect has a mass percentage content of 10-30% (e.g., 10%, 15%, 20%, 25%, 30%, etc.).

[0045] Preferably, the liquid beverage further includes a flavor modifier.

[0046] Preferably, the flavor modifier includes any one or a combination of at least two of erythritol, lemon concentrate, and blueberry concentrate.

[0047] Compared with the prior art, the present invention has the following beneficial effects:

[0048] This invention develops a composition that improves sleep quality during pregnancy. By combining aminobutyric acid, tea theanine, casein hydrolysate, and spearmint extract, it solves the problem that single-mechanism sleep aids have limited effects on insomnia during pregnancy, and greatly improves sleep structure and enhances sleep quality. Detailed Implementation

[0049] To further illustrate the technical means and effects of the present invention, the following describes the technical solution of the present invention in conjunction with preferred embodiments of the present invention. However, the present invention is not limited to the scope of the embodiments.

[0050] In the following specific embodiments, lily is added to the composition in the form of lily fleshy scale leaf powder, lotus seed is added to the composition in the form of mature lotus seed powder, and pistachio is added to the composition in the form of pistachio kernel powder.

[0051] The sources of raw materials / components involved in the following specific embodiments are shown in Table 1.

[0052] Table 1

[0053]

[0054] Preparation Example 1-1

[0055] This preparation example provides a casein hydrolysate, prepared by the following method:

[0056] (1) Mix casein and water at a ratio of 1:20 g / mL and microwave (power 200 W, time 20 min). After microwave treatment, filter and collect the filtrate to obtain the pretreated solution.

[0057] (2) Add 3% of the mass of the pretreatment solution of the compound enzyme (papain, aminopeptidase and trypsin in a mass ratio of 1:1:1) to the pretreatment solution and carry out the enzymatic hydrolysis reaction (react at 50℃ for 2 h) to obtain the enzymatic hydrolysate. Filter the enzymatic hydrolysate, collect the filtrate, and dry it to obtain casein hydrolysate.

[0058] Preparation Examples 1-2

[0059] This preparation example provides a casein hydrolysate, prepared by the following method:

[0060] (1) Mix casein and water at a ratio of 1:10 g / mL and microwave (100 W power for 30 min). After microwave treatment, filter and collect the filtrate to obtain the pretreated solution.

[0061] (2) Add 5% of the mass of the pretreatment solution of the compound enzyme (papain, aminopeptidase and trypsin in a mass ratio of 1:5:1) to the pretreatment solution and carry out the enzymatic hydrolysis reaction (react at 45℃ for 3 h) to obtain the enzymatic hydrolysate. Filter the enzymatic hydrolysate, collect the filtrate, and dry it to obtain casein hydrolysate.

[0062] Preparation Examples 1-3

[0063] This preparation example provides a casein hydrolysate, prepared by the following method:

[0064] (1) Mix casein and water at a ratio of 1:30 g / mL and microwave (300 W power for 10 min). After microwave treatment, filter and collect the filtrate to obtain the pretreated solution.

[0065] (2) Add 5% of the mass of the pretreatment solution of the compound enzyme (papain, aminopeptidase and trypsin in a mass ratio of 5:1:5) to the pretreatment solution and carry out the enzymatic hydrolysis reaction (react at 55℃ for 1 h) to obtain the enzymatic hydrolysate. Filter the enzymatic hydrolysate, collect the filtrate, and dry it to obtain casein hydrolysate.

[0066] Preparation Examples 1-4

[0067] This preparation example provides a casein hydrolysate, which differs from preparation example 1-1 only in that, in step (1), casein is mixed with water and then subjected to ultrasonic extraction (power of 200 W and time of 20 min), and the filtrate is collected after ultrasonic extraction to obtain a pretreated solution. The remaining steps are consistent with preparation example 1-1.

[0068] Preparation Examples 1-5

[0069] This preparation example provides a casein hydrolysate, which differs from preparation example 1-1 only in that the complex enzyme in step (2) is adjusted to a mass ratio of papain and aminopeptidase of 1:1, while the remaining steps are consistent with preparation example 1-1.

[0070] Preparation Examples 1-6

[0071] This preparation example provides a casein hydrolysate, which differs from preparation example 1-1 only in that the complex enzyme in step (2) is adjusted to a mass ratio of papain and trypsin of 1:1, while the remaining steps are consistent with preparation example 1-1.

[0072] Preparation Examples 1-7

[0073] This preparation example provides a casein hydrolysate, which differs from preparation example 1-1 only in that, in step (2), the complex enzyme is adjusted to a mass ratio of aminopeptidase and trypsin of 1:1, and the remaining steps are consistent with preparation example 1-1.

[0074] Preparation Example 2-1

[0075] This preparation example provides a spearmint extract, prepared by the following method:

[0076] Spearmint powder and water were mixed at a material-to-liquid ratio of 1:10 g / mL and subjected to microfluidic extraction (pressure 150 MPa, temperature 30℃, material circulation 5 times) to obtain spearmint extract; the spearmint extract was filtered, the filtrate was collected and dried to obtain spearmint extract.

[0077] Preparation Example 2-2

[0078] This preparation example provides a spearmint extract, prepared by the following method:

[0079] Spearmint powder and water were mixed at a material-to-liquid ratio of 1:5 g / mL and subjected to microfluidic extraction (pressure 100 MPa, temperature 20℃, material circulation 6 times) to obtain spearmint extract; the spearmint extract was filtered, the filtrate was collected and dried to obtain spearmint extract.

[0080] Preparation Examples 2-3

[0081] This preparation example provides a spearmint extract, prepared by the following method:

[0082] Spearmint powder and water were mixed at a material-to-liquid ratio of 1:20 g / mL and subjected to microfluidic extraction (pressure 200 MPa, temperature 40℃, material circulation 3 times) to obtain spearmint extract; the spearmint extract was filtered, the filtrate was collected and dried to obtain spearmint extract.

[0083] Preparation Examples 2-4

[0084] This preparation example provides a spearmint extract, which differs from Preparation Example 2-1 only in that the pressure of the microfluidic extraction is adjusted to 80 MPa, while the rest of the steps are the same as those in Preparation Example 2-1.

[0085] Preparation Examples 2-5

[0086] This preparation example provides a spearmint extract, which differs from Preparation Example 2-1 only in that the pressure of the microfluidic extraction is adjusted to 120 MPa, while the rest of the steps are the same as those in Preparation Example 2-1.

[0087] Preparation Examples 2-6

[0088] This preparation example provides a spearmint extract, which differs from Preparation Example 2-1 only in that the spearmint powder is mixed with water and then heated and refluxed for extraction three times, with each extraction lasting 1 hour, to obtain a spearmint extract. The remaining steps are consistent with Preparation Example 2-1.

[0089] Example 1

[0090] This embodiment provides a composition comprising, by weight parts, 1.5 parts of γ-aminobutyric acid, 1.3 parts of tea theanine, 2 parts of casein hydrolysate provided in Preparation Example 1-1, 1 part of spearmint extract provided in Preparation Example 2-1, 0.02 parts of lily, 0.02 parts of lotus seed, 0.02 parts of pistachio, 0.00015 parts of vitamin B6, and 0.07 parts of magnesium gluconate.

[0091] Example 2

[0092] This embodiment provides a composition comprising, by weight parts, 1.2 parts of γ-aminobutyric acid, 1.5 parts of tea theanine, 1 part of casein hydrolysate provided in Preparation Examples 1-2, 2 parts of spearmint extract provided in Preparation Examples 2-2, 0.01 parts of lily, 0.03 parts of lotus seed, 0.01 parts of pistachio, 0.0001 parts of vitamin B6, and 0.08 parts of magnesium gluconate.

[0093] Example 3

[0094] This embodiment provides a composition comprising, by weight parts, 2 parts of γ-aminobutyric acid, 1 part of tea theanine, 3 parts of casein hydrolysate provided in Preparation Examples 1-3, 1 part of spearmint extract provided in Preparation Examples 2-3, 0.03 parts of lily, 0.01 parts of lotus seed, 0.03 parts of pistachio, 0.0001 parts of vitamin B6, and 0.08 parts of magnesium gluconate.

[0095] Examples 4 to 7

[0096] Examples 4 through 7 each provide a composition, which differs from Example 1 only in that the casein hydrolysate provided in Preparation Example 1-1 is replaced with the casein hydrolysate provided in Preparation Examples 1-4 through 1-7 in equal mass, while the rest of the formulation remains the same as in Example 1.

[0097] Examples 8 to 10

[0098] Examples 8 to 10 each provide a composition, which differs from Example 1 only in that the spearmint extract provided in Preparation Example 2-1 is replaced with the spearmint extract provided in Preparation Examples 2-4 to 2-6 in equal mass, while the rest of the formulation remains the same as in Example 1.

[0099] Example 11

[0100] This embodiment provides a composition that differs from Example 1 only in that lily bulbs are removed, and the mass fractions of lotus seeds and pistachios are each adjusted to 0.03 parts. The rest of the formula remains the same as in Example 1.

[0101] Example 12

[0102] This embodiment provides a composition that differs from Example 1 only in that lotus seeds are removed, and the mass fractions of lily bulbs and pistachios are each adjusted to 0.03 parts. The rest of the formula remains the same as in Example 1.

[0103] Example 13

[0104] This embodiment provides a composition that differs from Example 1 only in that pistachios are removed, and the mass fractions of lily bulbs and lotus seeds are each adjusted to 0.03 parts. The rest of the formula remains the same as in Example 1.

[0105] Example 14

[0106] This embodiment provides a composition that differs from Example 1 only in that vitamin B6 is removed, while the rest of the formulation remains the same as in Example 1.

[0107] Example 15

[0108] This embodiment provides a composition that differs from Example 1 only in that magnesium gluconate is removed, while the rest of the formulation remains the same as in Example 1.

[0109] Example 16

[0110] This embodiment provides a composition comprising, by mass parts, 1.5 parts of γ-aminobutyric acid, 1.3 parts of tea theanine, 2 parts of casein hydrolysate provided in Preparation Example 1-1, and 1 part of spearmint extract provided in Preparation Example 2-1.

[0111] Comparative Example 1

[0112] This comparative example provides a composition that differs from Example 1 only in that γ-aminobutyric acid is removed, and the reduced mass fraction is made up by tea theanine, casein hydrolysate, and spearmint extract in a mass ratio of 1.3:2:1. All other formulations are consistent with Example 1.

[0113] Comparative Example 2

[0114] This comparative example provides a composition that differs from Example 1 only in that the theanine in tea leaves is removed, and the reduced mass fraction is made up by γ-aminobutyric acid, casein hydrolysate, and spearmint extract in a mass ratio of 1.5:2:1. All other formulations are consistent with Example 1.

[0115] Comparative Example 3

[0116] This comparative example provides a composition that differs from Example 1 only in that casein hydrolysate is removed, and the reduced mass fraction is made up by γ-aminobutyric acid, tea theanine, and spearmint extract in a mass ratio of 1.5:1.3:1. All other formulations are consistent with Example 1.

[0117] Comparative Example 4

[0118] This comparative example provides a composition that differs from Example 1 only in that spearmint extract is removed, and the reduced mass fraction is made up by γ-aminobutyric acid, tea theanine, and casein hydrolysate in a mass ratio of 1.5:1.3:2. The rest of the formulation remains the same as in Example 1.

[0119] Application Example 1

[0120] This application example provides a liquid beverage comprising, by weight percentage 100%, 30% of the composition provided in Example 1, 5% erythritol, 10% blueberry concentrate, 1% lemon concentrate, and the remainder being water.

[0121] Application Example 2

[0122] This application example provides a liquid beverage comprising, by weight percentage, 20% of the composition provided in Example 2, 2% erythritol, 15% blueberry concentrate, 0.7% lemon concentrate, and the remainder being water.

[0123] Application Example 3

[0124] This application example provides a liquid beverage comprising, by weight percentage 100%, 10% of the composition provided in Example 3, 10% erythritol, 8% blueberry concentrate, 1.5% lemon concentrate, and the balance being water.

[0125] Application Examples 4-16

[0126] Application Examples 4-16 each provide a liquid beverage, the only difference from Application Example 1 being that the composition provided in Example 1 is replaced with the compositions provided in Examples 4-16 respectively, while the rest of the formulation remains the same as in Application Example 1.

[0127] Comparative Application Examples 1-4

[0128] Comparative Application Examples 1-4 each provide a liquid beverage, the only difference from Application Example 1 being that the composition provided in Example 1 is replaced with the compositions provided in Comparative Examples 1-4 respectively, while the rest of the formulation remains the same as Application Example 1.

[0129] Test Example 1

[0130] Security testing:

[0131] (1) Test sample: Weigh 12 g of the liquid beverage provided in each application example and the control application example, add pure water to prepare 25 mL of test solution.

[0132] (2) Test method:

[0133] SPF-grade ICR mice (starting weight 18-22 g) were randomly divided into 20 groups of 3 mice each. They were acclimatized to the environment (temperature 20-25℃, relative humidity 30-70%, controlled light and dark for 12 hours each). Then, each mouse was administered a single dose of one of the 20 test solutions at 10000 mg / kg body weight via gavage (fasting was allowed before the experiment, but water intake was not restricted), followed by a 3-hour fast. Animals were observed daily for 14 consecutive days. They were weighed weekly, and gross necropsies were performed on dead animals and surviving animals at the end of the observation period.

[0134] (3) Test results:

[0135] None of the mice showed death or abnormal symptoms within 14 days, and their weight remained normal. Gross necropsy and visual inspection of the animals after the experiment showed no abnormalities. Specific information is shown in Table 2. The acute oral LD50 of each test sample in mice was >10000 mg / kg body weight. According to the limit method stipulated in GB 15193.3-2014 "National Food Safety Standard Acute Oral Toxicity Test", no acute oral toxicity was observed.

[0136] Table 2

[0137]

[0138] Test Example 2

[0139] Evaluation of its sleep aid efficacy:

[0140] (1) Test samples: liquid beverages provided in each application example and the comparative application example.

[0141] (2) Test method:

[0142] One hundred female subjects aged 25-40 years were selected and divided into 20 groups of 5 people each. Each group drank a different liquid beverage.

[0143] Each participant sat quietly for 30 minutes before bedtime each night, then drank 25 mL of the tested liquid beverage once a day for 21 consecutive days. Participants were prohibited from taking other similar preparations, such as sleeping pills or tranquilizers; they were also prohibited from ingesting any sleep-affecting preparations via intravenous drip, injection, oral administration, or any other form. Sleep patterns were monitored using a fitness tracker.

[0144] (3) Test indicators:

[0145] Deep sleep, also known as slow-wave sleep or non-rapid eye movement (NREM) sleep stage 3, is a crucial stage in the sleep cycle. Light sleep, namely NREM sleep stages 1 and 2, constitutes the largest portion of the sleep cycle and plays an important role in sleep quality. Rapid eye movement (REM) sleep is the most neurally active stage of the sleep cycle and is closely related to higher cognitive functions such as dreams and memory consolidation. The total duration of nighttime sleep is the sum of the duration of deep sleep, light sleep, and REM sleep, representing the total duration of sleep throughout the night.

[0146] The duration of deep sleep, light sleep, REM sleep, and nighttime sleep were measured on day 0 and day 21 using fitness trackers, and the growth rate of sleep duration for each subject was calculated.

[0147] The sleep duration growth rate = (T1-T0) / T0×100%; where T1 is the deep sleep duration, light sleep duration, REM sleep duration or nighttime sleep duration on day 21, and T0 is the deep sleep duration, light sleep duration, REM sleep duration or nighttime sleep duration on day 0.

[0148] (4) Test results:

[0149] The average growth rate of various sleep durations of the five subjects who drank the tested liquid beverages was calculated, and the results are shown in Table 3.

[0150] Table 3

[0151]

[0152] The data from Application Example 1 and Comparative Application Examples 1-4 show that the combination of GABA, tea theanine, casein hydrolysate, and spearmint extract has a significant synergistic effect in improving sleep quality and prolonging nighttime sleep time and deep sleep time.

[0153] A comparison of the data from Application Example 1 and Application Examples 4-7 shows that microwave treatment of casein raw materials during the preparation of casein hydrolysate can better extract the active ingredients in casein and improve the sleep-promoting effect of the product. In addition, the enzymatic hydrolysis of microwave-treated products by combining papain, aminopeptidase and trypsin can better retain the active ingredients in casein that improve sleep quality during pregnancy, and the product has a better sleep-promoting effect.

[0154] A comparison of the data from Application Example 1 and Application Examples 8-10 shows that the preparation process of spearmint extract can better extract the active ingredients in spearmint, thereby improving the effect of spearmint extract on sleep quality. In addition, controlling the pressure of microfluidic extraction within the range of 100-200 MPa can further improve the extraction effect of sleep-promoting active ingredients in spearmint.

[0155] A comparison of the data from Application Example 1 and Application Examples 11-13 shows that lily bulbs, lotus seeds, and pistachios have a significant synergistic effect in prolonging nighttime sleep time and deep sleep time.

[0156] A comparison of the data from Application Example 1 with Application Examples 14 and 15 shows that the addition of vitamin B6 and magnesium gluconate to the composition can further enhance the overall effect of the composition on improving sleep quality.

[0157] The applicant declares that the technical solution of this invention is illustrated by the above embodiments, but this invention is not limited to the above embodiments, that is, it does not mean that this invention must rely on the above embodiments to be implemented. Those skilled in the art should understand that any improvements to this invention, equivalent substitutions of raw materials for the products of this invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of this invention.

[0158] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the protection scope of the present invention.

[0159] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not describe the various possible combinations separately.

Claims

1. A composition having the effect of improving sleep quality during pregnancy, characterized in that, The composition includes GABA, tea theanine, casein hydrolysate, and spearmint extract.

2. The composition according to claim 1, characterized in that, The composition comprises, by weight parts, 1.2-2 parts of GABA, 1-1.5 parts of tea theanine, 1-3 parts of casein hydrolysate and 1-2 parts of spearmint extract.

3. The composition according to claim 1 or 2, characterized in that, The casein hydrolysate is prepared by a method including the following steps: (1) mixing casein raw material with water, performing microwave treatment, filtering and collecting the filtrate after microwave treatment to obtain a pretreated solution; (2) mixing the pretreated solution with a complex enzyme, performing an enzymatic hydrolysis reaction to obtain an enzymatic hydrolysate, filtering and collecting the filtrate, and drying to obtain the casein hydrolysate.

4. The composition according to claim 3, characterized in that, The ratio of casein raw material to water in step (1) is 1:10-1:30 g / mL; preferably, the power of microwave treatment in step (1) is 100-300 W and the microwave treatment time is 10-30 min.

5. The composition according to claim 3 or 4, characterized in that, The complex enzyme in step (2) includes papain, aminopeptidase and trypsin; preferably, the mass ratio of papain, aminopeptidase and trypsin is (1-5):(1-5):(1-5); preferably, the mass percentage of the complex enzyme in the pretreatment solution is 1-5%; preferably, the temperature of the enzymatic hydrolysis reaction is 45-55℃ and the time of the enzymatic hydrolysis reaction is 1-3 h.

6. The composition according to any one of claims 1-5, characterized in that, The spearmint extract is prepared by a method comprising the following steps: mixing spearmint raw material with water and performing microjets extraction to obtain spearmint extract; filtering the spearmint extract, collecting the filtrate, and drying it to obtain spearmint extract; preferably, the ratio of spearmint raw material to water is 1:5-1:20 g / mL; preferably, the pressure of the microjets extraction is 100-200 MPa, the temperature of the microjets extraction is 20-40℃, and the number of material cycles in the microjets extraction is 3-6 times.

7. The composition according to any one of claims 1-6, characterized in that, The composition further includes plant-derived components; the plant-derived components include any one or a combination of at least two of lily, lotus seed or pistachio, preferably a combination of lily, lotus seed and pistachio; preferably, the mass ratio of lily, lotus seed and pistachio is (1-3):(1-3):(1-3).

8. The composition according to any one of claims 1-7, characterized in that, The composition also includes vitamin B6 and / or magnesium gluconate.

9. The composition according to any one of claims 1-8, characterized in that, The composition comprises GABA, tea theanine, casein hydrolysate, spearmint extract, lily, lotus seed, pistachio, vitamin B6, and magnesium gluconate; preferably, by weight parts, the composition comprises 1.2-2 parts GABA, 1-1.5 parts tea theanine, 1-3 parts casein hydrolysate, 1-2 parts spearmint extract, 0.01-0.03 parts lily, 0.01-0.03 parts lotus seed, 0.01-0.03 parts pistachio, 0.0001-0.0002 parts vitamin B6, and 0.06-0.08 parts magnesium gluconate.

10. A liquid beverage, characterized in that, The liquid beverage comprises water and the composition according to any one of claims 1-9; preferably, the composition according to any one of claims 1-9 comprises 10-30% by mass in the liquid beverage; preferably, the liquid beverage further comprises a flavor modifier; preferably, the flavor modifier comprises any one or a combination of at least two of erythritol, lemon concentrate, and blueberry concentrate.

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