A composition for preventing alzheimer's disease, and a method of preparing the same and use thereof

Abstract

The application discloses a composition for preventing Alzheimer's disease and a preparation method and application thereof, and belongs to the technical fields of functional food, health food and medicines. The composition comprises a basic component and a functional component. The basic component is 50-80 parts of wheat green pigment, and the functional component is 2-10 parts and is composed of saffron extract and spearmint extract. The weight ratio of the saffron extract to the spearmint extract is 1.2:1-1.8:1. The composition has the effects of preventing or treating Alzheimer's disease or delaying the disease condition of Alzheimer's disease, can be applied to health food or functional food in the future, and has a medicinal potential.

Description

Technical Field

[0001] This invention relates to the fields of functional foods, health foods, and pharmaceuticals, and in particular to a composition for preventing Alzheimer's disease, its preparation method, and its uses. Background Technology

[0002] Alzheimer's disease (AD), also known as senile dementia or dementia, primarily affects the elderly. Globally, there are currently 50 million patients, making it the third leading cause of disability and death among the elderly, after cardiovascular disease and malignant tumors. With the aging population, this number is expected to soon surpass 100 million, and there is a trend towards younger patients. my country currently has approximately 10 million Alzheimer's patients, the largest number in the world, equivalent to the total number of patients in all developed countries. Experts predict that the number of Alzheimer's patients in China will continue to increase with the aging population, reaching nearly 20 million by 2030.

[0003] The unclear pathogenesis, complex causes, long course, and continuous progression of Alzheimer's disease are the main challenges in the development of AD drugs. Alzheimer's disease has been known for over 100 years, but only five drugs are currently available for clinical treatment globally: donepezil, rivastigmine, galantamine hydrobromide, memantine, and GV-971 (sodium mannoside capsules), which was launched in China at the end of 2019. Cholinesterase inhibitors are currently the main drugs used to improve cognitive function in mild to moderate patients. Representative drugs include donepezil and galantamine. Cholinesterase inhibitors work by inhibiting acetylcholinesterase in the synaptic cleft, thereby reducing the hydrolysis of acetylcholine released from presynaptic neurons into the synaptic cleft, and thus enhancing stimulation of cholinergic receptors. NMDA receptor antagonists, represented by memantine, have the effect of regulating glutamate activity and are used to treat patients in the middle and late stages. Brain metabolism activators, such as piracetam, are sometimes used clinically.

[0004] However, health supplements and functional foods for the prevention of Alzheimer's disease are still very scarce on the market. Currently, brain health products are mainly composed of unsaturated fatty acids and phospholipids such as fish oil and krill oil, which are prone to oxidation and rancidity, have difficult-to-blend flavors, and are mostly in capsule form, resulting in a limited product range. Summary of the Invention

[0005] To address the aforementioned problems, the present invention provides a composition for the prevention and / or treatment of Alzheimer's disease, wherein the composition comprises a basic component and a functional component; by weight, the basic component is 50-80 parts of wheatgrass, and the functional component is 2-10 parts, composed of saffron extract and spearmint extract, wherein the weight ratio of the saffron extract to the spearmint extract is 1.2:1 to 1.8:1; each 100g of the wheatgrass contains 800 The extract contains 1000mg-1800mg of chlorophyll, 1-12mg of B vitamins, and 1000mg-1800mg of total flavonoids with an SOD activity of 5000U-100000U; the saffron extract contains 3%wt-5%wt of crocin and 2%wt-3.5%wt of crocin aldehyde; the spearmint extract contains 14.5%wt-17.5%wt of rosmarinic acid and 24%wt-37%wt of total polyphenols.

[0006] In a preferred embodiment of the present invention, the weight ratio of saffron extract to spearmint extract in the composition is 1.5:1. More preferably, the composition comprises 4.5 parts by weight of saffron extract and 3 parts by weight of spearmint extract.

[0007] In this application, "wheatgrass" refers to a cellular nutrient with high nutritional and health benefits. For example, research has found that wheatgrass not only contains all the essential nutrients for human cells, such as proteins, amino acids, and vitamins, but also hundreds of active enzymes, mainly including superoxide dismutase (SOD), cytochrome oxidase, lipase, protease, amylase, catalase, nitrogen alkaloid oxidase, and aspartate aminotransferase. Wheatgrass is also considered the king of alkaline foods among plant-based foods, possessing immune-boosting properties, acting as an immune regulator, and also exhibiting antioxidant, detoxifying, cardiovascular disease prevention, liver protection, ulcer relief, wound healing promotion, anti-fatigue, anti-inflammatory and analgesic, antiviral, rheumatoid arthritis prevention and treatment, skin disease treatment, and deodorizing functions.

[0008] "Wheatgrass" can be made from the green leaves of plants such as barley seedlings, wheat seedlings, barley seedlings, buckwheat seedlings, rye seedlings, oat seedlings, and wild oats. For example, it can be made by physically breaking cell walls to extract juice and vacuum drying at room temperature, so that the activity of various nutrients in the green leaves of these plants can be preserved and easily absorbed by the human body.

[0009] In one specific embodiment of the present invention, barley seedlings with a growth cycle of 60-90 days and a length of 18-35cm are used as raw materials; preferably, pure overwintered barley seedlings are used as raw materials.

[0010] In one specific embodiment of the present invention, overwintered barley seedlings (25-35cm in length) are taken, rinsed with clean water in a three-stage washing tank, and then sterilized by continuous rinsing with ozone (at 3% of the water volume) in the third-stage washing tank. The leaves are then taken out and transported through a hot air cabinet, where hot air at 60-85°C (preferably 80°C) is used to remove the surface moisture of the leaves. After solid-liquid separation, the leaves are filtered, the filtrate is collected, concentrated under reduced pressure, and the concentrate is dried under vacuum at room temperature to obtain wheatgrass.

[0011] The preparation of wheatgrass can be carried out using methods already disclosed in the art, and is not limited to the present invention.

[0012] In this application, "saffron (scientific name: Crocus sativus L.)," also known as crocus or saffron crocus, is a perennial flowering plant belonging to the genus Crocus in the family Iridaceae. It is an aromatic plant native to southwestern Asia, first cultivated in Greece, and currently mainly grown in Shanghai, Zhejiang, Henan, and Hubei provinces in my country. Saffron is a valuable traditional Chinese medicine. According to the Compendium of Materia Medica, it is neutral in nature and sweet in taste, and has the functions of promoting blood circulation, nourishing blood, dispersing blood stasis, reducing swelling and relieving pain, cooling blood and detoxifying, relieving depression and calming the mind, and regulating qi and strengthening the stomach.

[0013] "Saffron extract" is an extract rich in active ingredients obtained from the stigma or petals of saffron. Modern scientific research has confirmed that some chemical substances in the stigma and petals of saffron, such as crocin, crocinaldehyde, crocin glycoside, crocinin, and crocin bitter substances, have anti-depressant and anti-anxiety effects on mental disorders, cerebrovascular diseases such as cerebral infarction, cerebral ischemia, and traumatic brain injury; neurodegenerative diseases such as Parkinson's disease and Alzheimer's disease (specifically, inhibiting the progression of AD, improving AD symptoms, protecting neurons, reducing the formation and aggregation of amyloid-derived protein, improving brain degenerative diseases, and reducing oxidative stress damage to brain cells); cardiovascular diseases such as myocardial ischemia and hypertrophy; anti-atherosclerosis; regulating blood lipids; anti-diabetes; and also have pharmacological effects such as enhancing immunity and lowering low-density lipoprotein and cholesterol.

[0014] Regarding "saffron extract," commercially available products can be used, such as... Saffron extract, Saffron Saffron extract, Safr'inside TM Saffron extracts, etc., can also be prepared using methods already disclosed in existing technologies, such as supercritical CO2 extraction, enzyme-assisted extraction, and ultrasound-assisted extraction.

[0015] In one specific embodiment of the present invention, saffron stigmas and petals are weighed, ground, sieved, and placed in an extraction vessel. Saffron extract is obtained using supercritical CO2 extraction. In another specific embodiment of the present invention, an enzyme-assisted extraction method is used. The pH of the extract is adjusted to 3.0–6.5, the temperature to 30–60°C, and 1%–3% (w / w) of enzyme is added. The enzymatic hydrolysis time is 1 hour, then the temperature is adjusted to 50–70°C, the material-to-liquid ratio is adjusted to 1:20, and extraction is carried out for 12 hours to obtain the extract. This extract is then filtered, purified, and dried to obtain the saffron extract. In yet another specific embodiment of the present invention, an ultrasonic-assisted extraction method is used to prepare the saffron extract. The extract is placed in an ultrasonic cleaner and ultrasonically treated at 45°C for 60 minutes. After extraction, filtration, purification, and drying, the saffron extract is obtained.

[0016] The preparation method of saffron extract can be any method disclosed in the art and is not limited to the present invention.

[0017] In this application, "spearmint (scientific name: *Mentha spicata* Linn.)" refers to a perennial herb belonging to the genus *Mentha* of the Lamiaceae family. It primarily grows in tropical and subtropical regions and has a pungent, sweet, and slightly warm nature. It possesses aromatic properties that promote blood circulation, dispel wind and cold, resolve blood stasis and detoxify, regulate qi, relieve pain, reduce swelling, and detoxify. Spearmint is a natural plant with no toxic side effects, low cost, and rapid efficacy. Historical herbal texts rarely mention it, only occasionally. Currently, spearmint is not included in pharmacopoeias domestically or internationally, nor is it used as a clinical drug.

[0018] Spearmint extract is extracted from spearmint leaves and contains more than 50 phenolic compounds, such as rosmarinic acid, salvianolic acid, shikonin, and caffeic acid, with rosmarinic acid being the main component. Studies have shown that rosmarinic acid can inhibit the phosphorylation of Tau protein and the formation of β-amyloid protein in the brain. Animal experiments have also shown that pre-administration of rosmarinic acid can counteract learning and memory impairment and hippocampal nerve damage in rats induced by intraventricular injection of Aβ, has a protective effect against spatial memory and recognition memory impairment and anxiety changes induced by Aβ1-42, and inhibits Aβ-induced astrocyte damage and the release of inflammatory factors.

[0019] Regarding "spearmint extract," commercially available products such as Neumentix can be used. TM Spearmint extract can also be obtained using methods commonly used in existing technologies, such as immersion extraction, ultrasonic-assisted immersion extraction, enzyme-assisted immersion extraction, and supercritical CO2 extraction. For example, the spearmint plant is washed, ground evenly with water, placed in an extraction device, and the spearmint extract is obtained through processes such as extraction, filtration, concentration, and drying.

[0020] The preparation method of spearmint extract can be any method disclosed in the art and is not limited to the present invention.

[0021] In another preferred embodiment of the present invention, the composition further comprises, by weight, 1-10 parts of a secondary functional component A. Secondary functional component A may be selected from oily neurotrophic components or nervonic acid disclosed in the prior art. The secondary functional component A is selected from any one or any combination of phosphatidylserine, cis-15-tetracosenoic acid, DHA algal oil, krill oil, arachidonic acid oil, fish oil, and extracts. Preferably, the secondary functional component A is phosphatidylserine or cis-15-tetracosenoic acid or a combination thereof, and by weight, the secondary functional component A is 4-7 parts.

[0022] In another preferred embodiment of the present invention, the composition further comprises, by weight, 1 to 4 parts of a secondary functional component B; the secondary functional component B may be selected from neurotrophic components extracted from plants or produced by fermentation; the secondary functional component B is selected from any one or any combination of green oat extract, γ-aminobutyric acid, green coffee extract, astaxanthin, ginkgo leaf extract, tea theanine, and bamboo leaf extract.

[0023] In a preferred embodiment of the invention, the composition further comprises excipients acceptable for pharmaceuticals, health foods, or functional foods.

[0024] As used herein, an acceptable excipient for a pharmaceutical, health food, or functional food may be any suitable excipient known in the art for the preparation of a pharmaceutical, health food, or functional food, provided that it is non-toxic to the recipient and does not interfere with the activity of other components of the pharmaceutical, health food, or functional food.

[0025] In a preferred embodiment of the present invention, the dosage form of the composition is powder, granules, tablets, hard capsules, soft capsules, or pills.

[0026] Regarding the powder, well-known powder formulation preparation processes in the art can be used. In a specific embodiment of the present invention, the above-mentioned basic components and functional components, and optionally secondary functional components A and B, can be prepared or commercially obtained through processes such as pretreatment, extraction or non-extraction, synthesis or non-synthesis, encapsulation or non-encapsulation, drying, pulverization, and sieving. The components are weighed in proportion, mixed, and packaged to prepare the powder.

[0027] Regarding granules, well-known granule formulation preparation processes can be used. In one specific embodiment of the present invention, the above-mentioned basic components and functional components, optional secondary functional components A and B, are mixed with granule excipients (e.g., sugars, dextrins, lactose, or sugar alcohols), granulated by dry or wet methods, and then dried at around 60-80°C with the moisture content controlled to within about 4%. The mixture is then sieved and granulated to obtain granules.

[0028] Regarding tablets, a tablet preparation process well known in the art can be used. In one specific embodiment of the present invention, the above-mentioned basic components and functional components, and optionally secondary functional component B, are weighed in proportion. The components are then sequentially added to a granulator and mixed. Using sodium carboxymethyl cellulose aqueous solution as a binder, dry granulation is performed. After granulation, the material is dried, sieved, and the particle size is controlled. Then, optionally, it is mixed with secondary functional component A, resistant dextrin, and magnesium stearate, and compressed into tablets to produce tablets.

[0029] Regarding hard capsules, well-known hard capsule dosage form preparation processes in the art can be used. In a specific embodiment of the present invention, empty capsules are first prepared, for example, using gelatin as a raw material. The preparation process of empty capsules includes sol-gelatinization, gelatin dipping for embryo formation, drying, shell removal, cutting, and finishing. Then, the above-mentioned basic components and functional components, optional secondary functional components A and B, diluents (sucrose, lactose, dextrin, etc.), and lubricants (microcrystalline cellulose, silica, modified starch, etc.) are weighed according to the proportion, mixed to prepare filling material, and the material is filled into the empty capsules. After the material is filled, the capsules are sealed. The sealing methods commonly used are flat sealing or lock sealing.

[0030] Regarding soft capsules, there are two production methods: compression and dripping. Well-known soft capsule formulation preparation processes can be used. In one specific embodiment of this invention, the soft capsule shell is first prepared, for example, using gelatin, glycerin, and water as a colloid, and then gelatinized to form a gelatin solution. Next, the above-mentioned basic components and functional components are weighed in proportion, and optional secondary functional components A and B are mixed evenly with soybean oil and beeswax to prepare a suspension of contents. This suspension is then mixed with the gelatin solution, compressed, shaped, washed, evaporated, and sorted to obtain the soft capsule.

[0031] Regarding the pills, weigh the above-mentioned basic components and functional components according to the proportions, optionally add secondary functional components A and B, sieve and premix, add appropriate amounts of wetting agent and binder (such as honey, liquid sugar alcohol, starch gelatinization liquid, fruit paste, jam, etc.), stir and mix to form a soft material, pellet it through a pelleting machine, dry it, granulate it, and then, with or without polishing and coating, the pills are obtained.

[0032] Preferably, the composition is in the form of a tablet, and the excipients include resistant dextrin, sodium carboxymethyl cellulose, and magnesium stearate. More preferably, in the composition, the excipients comprise, by weight, 10-20 parts of resistant dextrin, 0.1-1 parts of sodium carboxymethyl cellulose, and 0.1-1 parts of magnesium stearate.

[0033] Another aspect of the present invention provides a method for preparing the above composition, wherein the method comprises: granulating the wheatgrass with saffron extract, spearmint extract, and optionally the secondary functional component B, and then mixing and tableting with optionally other materials.

[0034] Unbound by theory, it is understood that granulation can increase the compressibility of materials and improve tableting stability. Furthermore, the granulation process also includes adding an aqueous solution of sodium carboxymethyl cellulose to assist in granulation.

[0035] Regarding granulation, it is generally necessary to control the appropriate particle size. This is to ensure that the granulating agent is mixed evenly with other materials and to control the flowability of the material to facilitate feeding.

[0036] In one specific embodiment of the present invention, the material drying temperature during the granulation process is controlled at 40-60°C to protect the activity of the active ingredients in wheatgrass extract, saffron extract, and spearmint extract.

[0037] In another aspect, the present invention also provides the use of the compositions described herein in the preparation of medicaments for the prevention and / or treatment of Alzheimer's disease.

[0038] In another aspect, the present invention also provides the use of the compositions described herein in the preparation of health foods or functional foods for the prevention of Alzheimer's disease and / or for the delay of the progression of Alzheimer's disease.

[0039] The composition of the present invention has the effect of preventing or treating Alzheimer's disease, or delaying the progression of Alzheimer's disease, and can be applied to health foods or functional foods in the future, and also has pharmaceutical potential. Detailed Implementation

[0040] The present invention will be further illustrated below with reference to specific embodiments, but the embodiments do not limit the present invention in any way. Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in this technical field.

[0041] Examples 1-5

[0042] Examples 1-5 provide a composition for preventing Alzheimer's disease, comprising a basic component and a functional component.

[0043] In the compositions of Examples 1-5, by weight, the basic component is 65 parts wheatgrass and the functional component is 7.5 parts. The functional component consists of 4.5 parts saffron extract and 3 parts spearmint extract.

[0044] In Examples 1-5, the wheatgrass was processed and produced by Jiangsu Boke Biotechnology Development Co., Ltd., and the specific preparation method is as follows:

[0045] Take overwintered barley seedlings (25-35cm in length), rinse them with clean water in a three-stage washing tank, and then sterilize them by rinsing with ozone (continuously) at 3% of the water volume in the third-stage washing tank. Take out the leaves and transport them through a hot air cabinet to remove the surface moisture of the leaves with hot air at 60-85℃. After solid-liquid separation, filter the solution, collect the filtrate, concentrate it under reduced pressure, and dry the concentrate under vacuum at room temperature to obtain wheatgrass.

[0046] The "wheatgrass" raw material obtained through extraction and drying was identified by the Zhejiang Gongzheng Testing Center as containing approximately 1300 mg of chlorophyll and 8 mg of B vitamins (including 1.2 mg of vitamin B1 and 2.6 mg of vitamin B2) per 100 g. The total flavonoid content was approximately 1400 mg and the SOD activity was approximately 20000 U. The obtained "wheatgrass" raw material served as the basic component of Examples 1-5.

[0047] In Examples 1-5, the saffron extract used was commercially available Saffron. Saffron extract. In Examples 1-5, the saffron extracts used contained approximately 4% wt of crocin and approximately 2.7% wt of crocin aldehyde.

[0048] In Examples 1-5, the spearmint extract used was commercially available Neumentix. TM Spearmint extract. In Examples 1-5, the spearmint extract used contained approximately 16% wt of rosmarinic acid and approximately 32% wt of total polyphenols.

[0049] Specifically, the composition (parts by weight) of the composition in Example 1 is: 65 parts wheatgrass, 4.5 parts saffron extract and 3 parts spearmint extract.

[0050] The compositions of Examples 2-3, based on the composition of Example 1, further include subfunctional component A and excipients.

[0051] In Example 2, the secondary functional component A is 5 parts phosphatidylserine. To facilitate tableting, the composition of Example 2 also includes 15 parts resistant dextrin as an excipient. Specifically, the composition (parts by weight) of Example 2 is: 65 parts wheatgrass, 4.5 parts saffron extract, 3 parts spearmint extract, 5 parts phosphatidylserine, and 15 parts resistant dextrin.

[0052] In Example 3, the secondary functional component A consisted of 3 parts phosphatidylserine and 2 parts cis-15-tetracosenoic acid. Specifically, the composition (parts by weight) of the composition in Example 3 was as follows: 65 parts wheatgrass, 4.5 parts saffron extract, 3 parts spearmint extract, 3 parts phosphatidylserine, 2 parts cis-15-tetracosenoic acid, 14 parts resistant dextrin, 0.4 parts sodium carboxymethyl cellulose, and 0.3 parts magnesium stearate.

[0053] The composition of Example 4, based on the composition of Example 1, further includes a secondary functional component B and excipients. In Example 4, secondary functional component B is 2 parts of green oat extract. Specifically, the composition (parts by weight) of the composition of Example 4 is: 65 parts wheatgrass, 4.5 parts saffron extract, 3 parts spearmint extract, 2 parts green oat extract, 16 parts resistant dextrin, 0.6 parts sodium carboxymethyl cellulose, and 0.2 parts magnesium stearate.

[0054] The composition of Example 5, based on the composition of Example 1, further includes subfunctional component A, subfunctional component B, and excipients. Specifically, the composition of Example 5 (parts by weight) is as follows: 65 parts wheatgrass, 4.5 parts saffron extract, 3 parts spearmint extract, 7 parts phosphatidylserine, 3 parts γ-aminobutyric acid, 17 parts resistant dextrin, 0.5 parts sodium carboxymethyl cellulose, and 0.5 parts magnesium stearate.

[0055] The phosphatidylserine, cis-15-tetracosenoic acid, green oat extract, γ-aminobutyric acid, and excipients (resistant dextrin, sodium carboxymethyl cellulose, and magnesium stearate) mentioned above are all commercially available products.

[0056] Examples 6-13

[0057] Examples 6-13 provide a composition for the prevention of Alzheimer's disease, the composition of which is shown in Table 1 below.

[0058] Table 1

[0059]

[0060]

[0061] In Examples 6-9, the saffron extract used was commercially available. Saffron extract; In Examples 10-13, the saffron extract used was commercially available Safr'inside. TM Saffron extract.

[0062] In Examples 6-13, spearmint extract was prepared by ultrasonic-assisted extraction. Spearmint and ethanol solution were mixed at a material-to-liquid ratio of 1:20, extracted at 35°C for 40 min, centrifuged to remove the precipitate, and the supernatant was concentrated under reduced pressure and freeze-dried under vacuum to obtain spearmint extract.

[0063] In Examples 6-13, the source of wheatgrass is the same as in Examples 1-5, and will not be repeated here. All other components are derived from commercially available products.

[0064] Regarding the composition of Example 1, simply mix all the solid powder components evenly.

[0065] The compositions of Examples 2-13 can be prepared by mixing or by formulation. The excipients selected for tableting formulations in Examples 2-13 can be prepared by tableting.

[0066] Specifically, the above-mentioned basic components and functional components, as well as optional secondary functional component B, are weighed according to the weight proportions. Each component is then added to a granulator in sequence, mixed, and dry granulation is performed using sodium carboxymethyl cellulose aqueous solution as a binder.

[0067] After granulation, the material is dried, sieved, and the particle size is controlled. Then, it is randomly mixed with secondary functional component A, resistant dextrin, and magnesium stearate, and compressed into tablets.

[0068] Comparative Examples 1a-1d

[0069] Comparative Example 1a differs from Example 1 in that it contains only 65 parts by weight of wheatgrass.

[0070] Comparative Example 1b differs from Example 1 in that it contains only 4.5 parts saffron extract and 3 parts spearmint extract.

[0071] Comparative Examples 1c-1d differ from Example 1 in that the composition of the functional components is different.

[0072] Comparative Example 1c contains 65 parts by weight of wheatgrass, 5.5 parts by weight of saffron extract, and 2 parts by weight of spearmint extract;

[0073] Comparative Example 1 contained 65 parts by weight of wheatgrass, 2 parts by weight of saffron extract, and 5.5 parts by weight of spearmint extract;

[0074] Apart from the difference in components, the preparation methods of the compositions of Comparative Examples 1a-1d are as described in Example 1 above.

[0075] Verification experiments and results analysis:

[0076] (1) Models: The rapid aging dementia model mouse SAMP8 and the normal aging model mouse SAMR1 were selected;

[0077] (2) Methods: The normal control group and the AD model group were administered 0.1 mL / 10 g BW of physiological saline by gavage daily, while the experimental group was administered 100 mg / kg BW of the sample (the composition of Examples 1-13 and Comparative Examples 1a-1d, dissolved in physiological saline) by gavage once daily for 8 consecutive weeks. The normal control group used SAMR1 mice, while the AD model group and the experimental group used SAMP8 mice, a rapid aging dementia model. The body weight of each animal was recorded weekly, and the injection dosage was adjusted accordingly.

[0078] (3) Tests and Results:

[0079] The Morris water maze model was used to test the improvement of spatial memory and learning ability in AD model mice. The Morris water maze consists of three parts: a circular pool, a platform, and a recording system. Twenty-four hours after the last gavage, a four-day training trial began, with four training sessions held daily at fixed times.

[0080] ① Orientation and Navigation Experiment: Before the experiment, mice were placed in a pool (without a platform) and allowed to swim freely for 2 minutes to familiarize themselves with the maze environment. At the start of training, a platform was placed in the pool, and mice were placed facing the pool wall from the four quadrants in a random order each time. The time it took for the mouse to find the platform was recorded by a video recording system; this was the escape latency (s) of the orientation and navigation experiment. If a mouse found the platform or could not find it within 120 seconds (the latency was recorded as 120 seconds), the experimenter would place it on the platform. The average latency of the mouse in four training sessions each day was taken as the mouse's latency for that day.

[0081] ② Space exploration experiment: After the incubation period test is completed, the mouse platform crossing test is carried out, that is, the underwater platform is removed and the number of times the mouse crosses the platform within 120 seconds is recorded.

[0082] Table 2: Test Results of the Morris Water Maze Model Method

[0083]

[0084]

[0085] ② Biochemical index determination: The effect of the sample on the level of antioxidant components in SAMP8 brain tissue was studied. The activities of superoxide dismutase (SOD) and catalase (CAT), and the contents of glutathione (GSH) and malondialdehyde (MDA) were detected by taking mouse brain tissue.

[0086] After the water maze test, the mice were anesthetized and euthanized, and the brain tissue was separated. The weight of the brain tissue to be tested was accurately weighed, and 9 times the amount of physiological saline was added at a weight (g) : volume (ml) ratio of 1 : 9. The tissue was homogenized under ice bath conditions to prepare a 10% tissue homogenate. After centrifugation at 10000 r / min for 20 min, the supernatant was collected, and the activities of SOD and CAT and the contents of GSH and MDA were detected according to the kit instructions.

[0087] Table 3: Results of Biochemical Indicators Measurement

[0088]

[0089]

[0090] From the results in Tables 2 and 3 above, we can see that:

[0091] 1) Results of evasion incubation period and number of crossings

[0092] The escape latency period reflects the spatial learning and memory consolidation ability of mice; the shorter the time, the stronger the spatial learning and memory consolidation ability of the mice.

[0093] The number of times a mouse crosses a platform reflects its short-term memory and judgment ability regarding spatial location. The more platforms a mouse crosses, the stronger its spatial exploration ability.

[0094] From the latency results of Examples 1-13 (experimental groups given the compositions of Examples 1-13 by gavage), the latency duration on the first day was approximately 103-105 s, on the second day it was approximately 91-93 s, and on the third day it was approximately 73-78 s. On the one hand, the latency duration shortened significantly over time. More importantly, although the latency duration of the experimental groups of Examples 1-13 was significantly higher than the corresponding data of the normal control group (96.41 s, 75.30 s, 44.51 s), it was also significantly lower than the data of the AD model group (110.27 s, 100.03 s, 92.51 s).

[0095] The number of times the table was crossed in Examples 1-13 (the experimental group given the composition of Examples 1-13 by gavage) was not significantly different from that in the normal control group, but was significantly higher than that in the AD model group.

[0096] Based on the data in Table 2, the intake of the compositions of Examples 1-13 of this invention can improve the spatial learning, spatial exploration, and memory consolidation abilities of SAMP8 mice in the rapid aging dementia model.

[0097] 2) Results of biochemical index determination

[0098] Based on the detection results of superoxide dismutase (SOD) and catalase (CAT) activities, glutathione (GSH) and malondialdehyde (MDA) content in mouse brain tissue.

[0099] The SOD activity of Examples 1-13 (experimental groups given the composition of Examples 1-13 by gavage) was approximately 61-63 U / mg, slightly lower than the normal control group (63.11±0.15 U / mg), with no significant difference between the two; however, it was significantly higher than the AD model group (54.71±0.36 U / mg).

[0100] The CAT activity in Examples 1-13 was approximately 16-19 U / mg, and the GSH content was approximately 12-15 nmol / mg. Although these values ​​were lower than those in the normal control group (25.83±0.27 U / mg and 16.09±0.26 nmol / mg, respectively), they were significantly higher than those in the AD model group (11.25±0.23 U / mg and 10.07±0.29 nmol / mg, respectively).

[0101] The MDA content in Examples 1-13 was approximately 29–34 nmol / mg, slightly higher than that in the normal control group (28.03 ± 0.33 nmol / mg), but significantly lower than that in the AD model group (68.19 ± 0.43 nmol / mg).

[0102] Based on the data in Table 3, ingestion of the compositions of Examples 1-13 of this invention significantly increased SOD and CAT activity and GSH content in SAMP8 of rapidly aging dementia model mice, and significantly reduced MDA content, with results closely resembling those of SAMR1 in normal aging model mice. This indicates that ingestion of the compositions of Examples 1-13 of this invention can increase the content of antioxidants in the brain tissue of dementia model mice, reduce the generation of lipid peroxidation product MDA, and thereby enhance the antioxidant capacity of the mice. Therefore, the compositions of Examples 1-13 have the potential to prevent or treat Alzheimer's disease, or to delay the progression of Alzheimer's disease.

[0103] 3) Compare experimental results

[0104] 3a) The composition of Comparative Example 1a differs from that of Example 1 in that it contains only 65 parts by weight of wheatgrass.

[0105] Overall, the results in Tables 2 and 3 show that the data in Comparative Example 1a are slightly better than those in the AD model group. This indicates that wheatgrass, as a basic nutrient, has a certain effect, but no significant improvement effect; specifically, it did not significantly improve the spatial learning, spatial exploration, or memory consolidation abilities of the SAMP8 mice in the rapid aging dementia model; apart from a significant decrease in malondialdehyde (MDA) content in the mouse brain tissue, the activities of superoxide dismutase (SOD) and catalase (CAT), and the content of glutathione (GSH) were only slightly higher than those in the AD model group, with no significant difference (P>0.05).

[0106] 3b) Comparative Example 1b differs from Example 1 in that it contains only 4.5 parts saffron extract and 3 parts spearmint extract.

[0107] Overall, the results in Tables 2 and 3 show that the data in Comparative Example 1b are better than those in the AD model group, demonstrating the role of saffron extract and spearmint extract in the treatment or prevention of AD.

[0108] However, the data from Comparative Example 1b were significantly inferior to those from Example 1. This indicates that while wheatgrass, as a basic nutrient, does not have a significant effect on improving AD, the combination of wheatgrass with saffron extract and spearmint extract allows wheatgrass to synergistically (or adjuvantly) significantly promote / enhance the therapeutic or preventative effects of saffron extract and spearmint extract on AD.

[0109] Unconstrained by theory, the inventors believe that wheatgrass may promote the absorption and utilization of active ingredients in saffron extract and spearmint extract.

[0110] 3c) Comparative Examples 1c and 1d differ from Example 1 only in the ratio of saffron extract to spearmint extract.

[0111] Overall, based on the results in Tables 2 and 3, the data results of Comparative Examples 1c and 1d are significantly better than those of the AD model group; however, they are significantly worse than those of Example 1, and also significantly worse than those of Examples 2-13.

[0112] During the product development process, the inventors discovered that wheatgrass, as a basic nutrient, has a significant effect on promoting / enhancing the therapeutic or preventative effects of saffron extract and spearmint extract in AD treatment. Subsequently, the inventors also conducted extensive experiments to evaluate the compound ratio of saffron extract and spearmint extract.

[0113] By comparing Comparative Examples 1b and 1c with Example 1, and with the data from Examples 2-13, it can be seen that when saffron extract and spearmint extract meet a specific ratio range (1.2:1 to 1.8:1), the combination of specific weight parts of the basic component (wheatgrass) and the functional components (saffron extract and spearmint extract) has the potential to prevent or treat Alzheimer's disease, or delay the progression of Alzheimer's disease. It can be applied to health foods or functional foods in the future, and also has medicinal potential.

[0114] It should be noted that while the preferred embodiments of the present invention are provided in this specification, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. These embodiments are not intended to impose additional limitations on the content of the present invention; their purpose is to provide a more thorough and comprehensive understanding of the disclosure of the present invention. Furthermore, the above-described technical features can be combined with each other to form various embodiments not listed above, all of which are considered to be within the scope of the present invention. Moreover, those skilled in the art can make improvements or modifications based on the above description, and all such improvements and modifications should fall within the protection scope of the appended claims.

Claims

1. A composition for the prevention and / or treatment of Alzheimer's disease, characterized in that, The composition comprises a basic component and a functional component; The base component, by weight, is 50-80 parts wheatgrass. The functional component is 2 to 10 parts, and is composed of saffron extract and spearmint extract, wherein the weight ratio of saffron extract to spearmint extract is 1.5:

1. Each 100g of the wheatgrass contains 800mg to 1800mg of chlorophyll, 1 to 12mg of B vitamins, 1000mg to 1800mg of total flavonoids, and 5000U to 100000U of SOD activity; The saffron extract contains 3% wt to 5% wt of crocin and 2% wt to 3.5% wt of crocin aldehyde. The spearmint extract contains 14.5% wt to 17.5% wt of rosmarinic acid and 24% wt to 37% wt of total polyphenols. The composition further comprises, by weight, 4-7 parts of a secondary functional component A; the secondary functional component A is phosphatidylserine or cis-15-tetracosenoic acid or a combination thereof. The composition further comprises, by weight, 1 to 4 parts of a secondary functional component B; the secondary functional component B is selected from any one or any combination of green oat extract, γ-aminobutyric acid, green coffee extract, astaxanthin, ginkgo leaf extract, tea theanine, and bamboo leaf extract.

2. The composition according to claim 1, characterized in that, The composition also contains excipients acceptable for pharmaceuticals, health foods, or functional foods.

3. The composition according to claim 2, characterized in that, The formulation of the composition is in the form of powder, granules, tablets, hard capsules, soft capsules, or pills.

4. The composition according to claim 3, characterized in that, The composition is in the form of tablets, and the excipients include resistant dextrin, sodium carboxymethyl cellulose, and magnesium stearate.

5. The composition according to claim 4, characterized in that, In the composition, by weight, the excipients comprise 10-20 parts of resistant dextrin, 0.1-1 parts of sodium carboxymethyl cellulose, and 0.1-1 parts of magnesium stearate.

6. The method for preparing the composition according to claim 1, characterized in that, The preparation method includes: granulating the wheatgrass with saffron extract, spearmint extract, and optionally the secondary functional component B, and then mixing and tableting with optionally other materials.

7. Use of the composition of any one of claims 1-6 in the preparation of a medicament for the prevention and / or treatment of Alzheimer's disease.

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