Composition of health food, dietary supplement or nutritious food

Abstract

The invention relates to a composition of health-care food, dietary supplement or nutritional food, and belongs to the technical field of health-care food. The health-care product composition disclosed by the invention is prepared from the following raw materials in parts by weight: 100 to 250 parts of GPC (L-alpha-glycerophosphorylcholine), 60 to 150 parts of PS (phosphatidylserine), 40 to 75 parts of tea leaf theanine, 30 to 80 parts of DHA (docosahexaenoic acid), 200 to 400 parts of lipoic acid, 10 to 25 parts of PQQ (pyrroloquinoline quinone) and 80 to 200 parts of coenzyme Q10. The health-care product disclosed by the invention has the functions of improving brain functions, relieving pressure and anxiety, improving sleep quality and preventing neurodegenerative diseases; the required raw materials are safe to eat, scientific in formula and remarkable in effect.

Description

Technical Field

[0001] The invention belongs to the technical field of health food and relates to a composition of health food, dietary supplement or nutritional food. Background Art

[0002] In the current social context, as the pace of life continues to accelerate, people's awareness of healthy diet is relatively insufficient, and the problem of population aging is becoming increasingly serious. The public's demand for improving brain function, relieving stress and anxiety, improving sleep quality, and preventing neurodegenerative diseases is showing a significant growth trend. In addition to traditional drug treatments and professional psychotherapy, preventive and early intervention measures have also received more and more attention.

[0003] Scientific research has found that a reasonable diet plays a vital role in maintaining brain health. In particular, foods rich in glycerophosphocholine (L-α-GPC), phosphatidylserine (PS), docosahexaenoic acid (DHA), pyrroloquinoline quinone (PQQ), lipoic acid (LA), coenzyme Q10, B vitamins, and a variety of antioxidants can provide the brain with essential nutritional support and help maintain the normal function of the nervous system. They can not only relieve stress and anxiety, improve sleep quality, but also enhance memory, and show positive effects in delaying the progression of Alzheimer's disease.

[0004] Given the significant benefits of these nutrients, developing functional foods that can be safely taken for a long time to improve brain cognition, memory, relieve stress and anxiety, improve sleep quality, and delay the progression of Alzheimer's disease not only has important health significance, but also contains huge market potential. According to market research institutions, with the improvement of consumers' health awareness and the increase in demand for functional foods, the market in this field will usher in significant growth in the next few years.

[0005] Specific ingredients and effects: L-α-glycerophosphorylcholine (L-α-GPC) is a water-soluble small molecule substance present in the human body. It is a biosynthetic precursor of acetylcholine, which is an important neurotransmitter in the central nervous system. Clinical studies have shown that L-α-GPC has a variety of clinical effects on the human body. It can increase the release of neurotransmitters, not only improve people's memory and cognition, but also has significant therapeutic effects on neurodegenerative diseases and Alzheimer's disease, so it is called the "anti-aging nutrient" of the brain. L-α-GPC has good safety, has passed safety assessments in many countries, and is approved for use as a food supplement. It was approved as a new food ingredient in March 2024.

[0006] Phosphatidylserine (PS) is an important membrane phospholipid that is commonly found in cell membranes. It is especially found in brain cells and has a variety of regulatory effects on the physiological activities of the brain. PS can regulate the conduction of nerve impulses and enhance brain memory function. It can make brain cells more active by increasing the number of brain spikes, enhancing the fluidity of brain cell membranes, and promoting the metabolism of glucose in brain cells, thereby helping to improve brain operation efficiency, stimulate the activation state of the brain, concentrate attention, and improve memory. PS also has the effect of soothing vascular smooth muscle cells, which can increase blood supply to the brain and relieve brain fatigue. Studies have found that PS can prevent the accumulation of beta-amyloid protein in the brain, which helps prevent or slow the progression of Alzheimer's disease. In addition, PS also has a strong antioxidant effect and can regulate the function of phagocytes. PS has good safety and is widely used in food, health products, medicine and feed industries around the world.

[0007] Theanine is a unique free amino acid that mainly exists in tea leaves, especially in green tea. It has a variety of health benefits. Theanine exerts an antidepressant effect by affecting the secretion of monoamine neurotransmitters, which can help relieve stress and improve sleep quality. Theanine can also protect nerve cells and prevent neurological diseases such as Alzheimer's disease and Parkinson's disease. In addition, theanine can also lower blood lipids and cholesterol, prevent cardiovascular diseases, and has antioxidant, anti-inflammatory and antibacterial effects.

[0008] DHA (Docosahexaenoic acid) is a polyunsaturated fatty acid and one of the main structural fats in the brain. It has important physiological functions and effects on the human body. DHA helps protect nerve cells from oxidative stress and inflammatory damage, has a positive effect on cognitive function and memory in adults, and helps maintain cognitive health in the elderly. DHA has a positive effect on improving emotional state, relieving anxiety and stress, and helps maintain a calm and happy mood.

[0009] Pyrroloquinoline quinone (PQQ) is a compound with multiple biological functions. It is widely present in nature and plays an important role in the human body. It can promote the production of neurotrophic factors, protect neurons from damage by neurotoxic substances, reduce apoptosis of nerve cells and improve cerebral blood flow.

[0010] Alpha-Lipoic Acid (LA) is a coenzyme existing in mitochondria. It is fat-soluble and water-soluble. It can eliminate free radicals that accelerate aging and cause disease. It can reach any part of the cell after being absorbed through the intestine. Alpha-Lipoic Acid is an important coenzyme in the body. It is an important auxiliary factor of pyruvate dehydrogenase, ketoglutarate dehydrogenase and aminocaproate dehydrogenase. It is one of the indispensable substances in the tricarboxylic acid cycle. It has antioxidant, hypoglycemic, nerve protection, liver protection and anti-inflammatory effects.

[0011] Coenzyme Q10 (Coenzyme Q10), also known as Ubiquinone, is a fat-soluble quinone compound present in the mitochondria of human cells and has important biological functions. It plays a key role in cellular energy metabolism and antioxidant defense system. It has the effects of anti-oxidation, cardiovascular and cerebrovascular protection, anti-fatigue, anti-aging, and immune regulation. It is suitable for mental workers, remote mobilization, cardiovascular disease patients and the middle-aged and elderly. Summary of the invention

[0012] The object of the present invention is to provide a composition of health food, dietary supplement or nutritional food.

[0013] Another object of the present invention is to provide a composition of a health food, a dietary supplement or a nutritious food and a preparation method thereof.

[0014] To achieve the above object, the present invention adopts the following technical solution: A composition of health food, dietary supplement or nutritional food comprises the following raw materials in parts by weight: 100-250 parts of GPC, 60-150 parts of PS, 40-75 parts of tea theanine, 30-80 parts of DHA, 200-400 parts of lipoic acid, 10-25 parts of PQQ and 80-200 parts of coenzyme Q10.

[0015] According to the above composition, the following raw materials are included in parts by weight: 120-160 parts of GPC, 80-120 parts of PS, 45-60 parts of tea theanine and 80-120 parts of DHA, 250-330 parts of lipoic acid, 15-25 parts of PQQ, and 80-120 parts of coenzyme Q10.

[0016] According to the above composition, the following raw materials are included in parts by weight: 150 parts of GPC, 100 parts of PS, 50 parts of tea theanine, 100 parts of DHA, 300 parts of lipoic acid, 20 parts of PQQ, and 100 parts of coenzyme Q10.

[0017] According to the above-mentioned composition, it is characterized in that it comprises the composition according to any one of claims 1 to 3, and a pharmaceutically acceptable excipient or food additive. Wherein, the excipient comprises at least one of the following: gelatin, pectin, beeswax, glycerin, titanium dioxide, starch, dextrin, microcrystalline cellulose, cross-linked cellulose, sodium carboxymethyl starch, sodium carboxymethyl cellulose, magnesium stearate, talc and micro-powdered silica. For edible excipients or food additives, as food additives that can be used and meet relevant standards, they must comply with the provisions of the "National Food Safety Standard for the Use of Food Additives" (GB2760-2024) of the People's Republic of China.

[0018] The dosage form of the above composition is tablets, soft capsules, hard capsules, soft candies (candies), solid beverages, liquid beverages and any other forms of oral consumption.

[0019] The preparation method of the tablet comprises the following steps: (1) Mixing, crushing and sieving the composition and auxiliary materials; (2) Mix the mixed powder and a wetting agent or a binder to make a soft material, pass it through a 20-mesh sieve to make wet granules and dry them; (3) Sieve the dried granules and compress them into tablets, and monitor the hardness and quality of the tablets; (4) Film-coat the tablets and package them after quality inspection.

[0020] The method for preparing the soft candy (candy) comprises the following steps: (1) Mixing the composition with other auxiliary materials, grinding and setting aside; (2) Vacuuming and degassing gelatin, glycerin, purified water and colorant sol to obtain a gelatin solution; (3) The mixture of step (1) is pressed into a mold by mixing with glue, and then dried, demoulded, and then quality inspected and packaged.

[0021] Test data

[0022] 1. Mouse toxicity experiment 1. Source of materials: 20 SPF Kunming mice, 16-20 g, half male and half female.

[0023] 2. Test method: Take 33 g of the composition prepared in Example 1 of the present invention, add distilled water to 200 mL, and orally gavage mice, 10 mL / kg·BW each time, 1 time every 24 hours, and the cumulative dose is 1.65 g / kg·BW (equivalent to 100 times the recommended daily intake of 0.0164 g / kg·BW for humans). Observe the poisoning symptoms and death symptoms of the animals within 2 weeks.

[0024] 3. Results and analysis: No obvious poisoning symptoms were observed in the 20 mice, and no death occurred. According to the acute toxicity classification of "Procedures and Methods for Toxicological Evaluation of Food Safety" (2003 edition), the health product of the present invention is non-toxic.

[0025] 2. 90-day feeding trial 1. Experimental animals: 80 SPF Wistar rats, 60-75 g, half male and half female.

[0026] 2. Sample: a sample prepared according to the formulation and process described in Example 1. The proposed human dose is 0.82 g / 50 kg·BW·day.

[0027] 3. Experimental method: Rats were randomly divided into three test groups and one control group, with 20 rats in each group, half male and half female. The control group was fed with normal basic block feed, while the test group was fed with samples mixed with different doses, and given orally for 13 consecutive weeks, once a day. The daily intake of rats in the low, medium and high dose groups was 0.41, 0.82 and 1.64 g / kg·BW respectively (equivalent to 25 times, 50 times and 100 times the intended human dose respectively). The observation was continued for 90 days.

[0028] 4. Observation indicators and results: General observation: The performance, behavior, toxicity and death of the animals were observed every day. The animals were weighed once a week, and the weekly food utilization rate and total food utilization rate were calculated. Results The growth and development and activities of the animals in each group were normal, without toxicity and death. There were no statistical differences in the weekly body weight, weekly weight gain, weekly food intake and weekly food utilization rate of the animals in each group, as well as the total weight gain, total food intake and total food utilization rate (P>0.05).

[0029] 5. Hematological examination: Determination of hemoglobin content (Hgb), red blood cell (RBC) and white blood cell (WBC) counts, and classification of white blood cells (lymphocytes, monocytes, neutrophils, eosinophils, and basophils). At the end of the experiment, all hematological indicators were within the normal range, and there was no statistical difference in hemoglobin, red blood cell and white blood cell counts, and white blood cell classification between the animals in each group and the control group (P>0.05).

[0030] 6. Determination of biochemical indices: Determination of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea nitrogen (BUN), cholesterol (CHO), triglyceride (TG), blood glucose (GLU), total protein (TP), albumin (ALB), and creatinine (CRE). At the end of the experiment, all biochemical indices of the experimental animals were within the normal range, and there was no statistical difference in the blood biochemical indices of the animals in each group compared with the control group (P>0.05).

[0031] 7. Pathological examination: The liver, kidney, spleen, testicle (or ovary), stomach and duodenum of all animals were removed, fixed with 12% formalin, embedded in paraffin, sliced, stained with HE, and histologically examined under a light microscope. No significant pathological changes were found in the major organs (heart, liver, spleen, lung, kidney, stomach, intestine, etc.).

[0032] 8. Conclusion: The health care product of the present invention is non-toxic.

[0033] 3. Assisted improvement of memory function test 1. Sample: soft candy (candy) prepared according to the formula and process described in Example 1. The proposed human dose is 0.82 g / 50 kg·BW·day.

[0034] 2. Kunming mice, weighing 18-23g. The mice were randomly divided into 4 groups: control group, low, medium and high (0.164g / kg·BW, 0.328g / kg·BW, 0.492g / kg·BW) dose groups, with half of the mice in each group being male and half female. The experimental observation began after continuous gavage for 30 days, and the animals in the control group were gavaged with distilled water. The platform jumping test and dark avoidance test were selected as observation indicators.

[0035] 3. Platform jumping test: A copper grid is installed at the bottom of the reaction box, and both ends of the grid are connected to a 36V power supply. The normal reaction of animals after receiving electric shock is to jump to the insulating platform in the box to avoid electric shock. Most animals may jump to the copper grid again or multiple times, and then quickly jump back to the platform after receiving electric shock. This training lasts for 5 minutes, and the number of times each mouse receives electric shock (or the number of errors) is recorded. Repeat the measurement after 24 hours, which is the memory retention test.

[0036] 4. Dark avoidance experiment The device is designed based on the dark-loving habits of mice. Half of the device is a dark room and the other half is a light room. There is a small hole connecting the light and dark rooms. The bottom of the dark room is equipped with an electrified copper grid and is connected to a timer that automatically records the latency time. The mice are shocked when they enter the dark room, and the timer stops automatically. The training starts the day after the last administration. During the experiment, the mice are placed in the light room with their backs facing the hole, and the timer is started at the same time. The animals pass through the hole and enter the dark room and are shocked. The timer stops automatically, the experiment ends, and the mice are removed. The interval time from the time each mouse is placed in the light room to the time it enters the dark room and is shocked, i.e. the latency period, is recorded. Repeat the measurement after 24 hours, and record the latency period for each animal to enter the dark room and the number of times it is shocked within 5 minutes.

[0037] 5. The results of the sample mouse jumping test are as follows (`X±S=10): Group Training latency (s) Test latency(s) Number of training errors (times) Number of test errors (times) Control group 41.0±28.5 108.31±50.5 3.2±1.1 1.3±1.0 Low dose group 41.8±24.4 131.7±43.2 3.1±1.1 1.2±1.0 Medium dose group 43.1±15.6 137.4±33.8 3.1±1.0 0.9±0.7 High dose group 43.7±20.3 141.6±31.4* 3.2±1.2* 0.6±0.4* *P<0.05

[0038] 6. The results of the light avoidance experiment on sample mice are as follows (`X±S=10): Group Training latency (s) Test latency(s) Number of training errors (times) Number of test errors (times) Control group 43.0±21.7 185.4±77.4 2.9±1.2 1.4±0.8 Low dose group 42.2±22.4 212.6±65.6 3.1±1.1 1.2±0.9 Medium dose group 40.9±23.0 225.8±62.3 2.8±1.1 0.6±0.6 High dose group 41.7±21.3 244.1±58.5* 2.9±1.0* 0.5±0.3* *P<0.05 7. The experimental results show that the test results of the experimental group are better than those of the control group, and the test results of the high-dose group are all better, indicating that the health food of the present invention has the effect of improving memory.

[0039] IV. Clinical Trials The finished product of the present invention was used to clinically treat patients in a hospital in Beijing, and the therapeutic effect was fully confirmed.

[0040] This group of 60 patients, 30 males and 30 females, aged between 26 and 53 years old, were randomly selected and had a history of infection with the new coronavirus. After recovery, they felt that their attention, memory, and reaction speed decreased. They took the health care product of Example 1 of the invention, 2 capsules each time, once a day, and 1 month was a course of treatment. After taking a course of treatment, no toxic side effects occurred. Among the 60 patients, 52 had reduced symptoms, more focused attention, and improved memory and reaction speed, with an effective rate of 87%.

[0041] This group of 46 patients, 20 males and 26 females, were randomly selected, aged between 28 and 32 years old, all of whom were engaged in mental work, working 44-52 hours per week, and often felt brain fatigue, sleepiness, difficulty falling asleep at night, and easy to wake up from dreams during sleep. Taking the health care product of Example 1 of the invention, 2 capsules each time, once a day, 1 month as a course of treatment, after taking a course of treatment, there was no toxic side effect, 39 of the 60 patients had reduced symptoms, improved sleep quality, reduced fatigue, and an effective rate of 85%.

[0042] This group of 37 patients, 17 males and 20 females, were randomly selected, aged between 63 and 71 years old. The health care product of Example 1 of the invention was taken, 2 capsules each time, once a day, 1 month as a course of treatment, and after taking a course of treatment, there was no toxic side effect, 39 out of 60 patients, with an effective rate of 85%. DETAILED DESCRIPTION

[0043] The present invention is further described below in conjunction with some specific embodiments. Example 1

[0044] A composition of a health food, a dietary supplement or a nutritional food comprises the following raw materials in parts by weight: 150 g of GPC, 100 g of PS, 50 g of tea theanine, 100 g of DHA, 300 g of lipoic acid, 20 g of PQQ and 100 g of coenzyme Q10.

[0045] The preparation method of the composition comprises the following steps: (1) The drug and excipients are crushed to the required fineness, and then sieved through a sieve. The crushed drug and excipients are mixed evenly in a certain proportion, and the drug powder is mixed with a wetting agent or adhesive to form a soft material, which is then sieved through a 20-mesh sieve to form wet granules, which are then dried. (2) The dried granules are again sieved through a 20-mesh sieve for sorting. The prepared granules are pressed into tablets by a tablet press. The hardness and quality of the tablets are monitored in the process. The compressed tablets are coated by a film coating method.

[0046] (3) The dried granules are screened again with a 20-mesh sieve. The prepared granules are compressed into tablets by a tablet press. The hardness and quality of the tablets are monitored during the process. The compressed tablets are coated by a film coating method. The finished tablets are packaged after quality inspection.

[0047] Example 2 A composition of a health food, a dietary supplement or a nutritional food comprises the following raw materials in parts by weight: 100 g of GPC, 100 g of PS, 100 g of tea theanine, 100 g of DHA, 300 g of lipoic acid, 50 g of PQQ and 100 g of coenzyme Q10.

[0048] The preparation method of the composition comprises the following steps: (1) Weigh each component according to the formula and mix them evenly. Soak gelatin in purified water for 30 minutes and heat to 70℃±5℃ to dissolve. Soak agar in purified water for 1-2 hours and heat to 80-90℃ to dissolve.

[0049] (2) Mix sugar, glucose syrup and purified water and heat to 110-115°C. Add gelatin solution and agar solution, then add active ingredient mixture and stir evenly. Add citric acid and flavoring, and pour the mixture into a mold.

[0050] (3) After cooling, dry at 25-30℃ and 30%-40% humidity to a moisture content of 15%-20%. After demolding, the soft candy (candy) is packaged with moisture-proof and airtight packaging materials.

[0051] It should be noted that the embodiments provided in this patent specification are only used to illustrate the specific implementation of the present invention, and are not the only limitation of the present invention. Those skilled in the art should understand that the present invention can be implemented in a variety of different forms, not limited to the specific embodiments described in this specification. The purpose of providing these embodiments is to make the disclosure of the present invention more thorough and comprehensive. In fact, it is obvious to those of ordinary skill in the art that various modifications, equivalent substitutions and improvements can be made to the present invention without departing from the scope or spirit of the present invention. For example, the features described as an embodiment in this specification can also be applied to other embodiments to produce further embodiments. The protection scope of the present invention is not limited to the above-mentioned specific embodiments, but also includes all modifications, equivalent substitutions and improvements within the spirit and principles of the present invention. Specifically, the above-mentioned technical features can continue to be combined with each other to form other embodiments not listed in this specification, and these embodiments are also regarded as the scope of the present invention. Further, for those of ordinary skill in the art, appropriate improvements or changes can be made according to the description of this specification, and all these improvements and changes should belong to the protection scope of the claims attached to the present invention.

Claims

1. A composition of a health food, a dietary supplement or a nutritious food, characterized in that: The invention comprises the following raw materials in parts by weight: 100-250 parts of GPC (L-α-glycerophosphorylcholine, the same below), 60-150 parts of PS (phosphatidylserine, the same below), 40-75 parts of tea theanine and 80-150 parts of DHA (docosahexaenoic acid, the same below), 200-400 parts of lipoic acid, 10-25 parts of PQQ (pyrroloquinoline quinone, the same below), and 80-200 parts of coenzyme Q10.

2. The composition according to claim 1, characterized in that The invention comprises the following raw materials in parts by weight: 120-160 parts of GPC, 80-120 parts of PS, 45-60 parts of tea theanine, 80-120 parts of DHA, 250-330 parts of lipoic acid, 15-25 parts of PQQ and 80-120 parts of coenzyme Q10.

3. The composition according to claim 2, characterized in that The weight proportions of the active ingredients are: 150 parts of GPC, 100 parts of PS, 50 parts of tea theanine, 100 parts of DHA, 300 parts of lipoic acid, 20 parts of PQQ, and 100 parts of coenzyme Q10.

4. A composition of a health food, a dietary supplement or a nutritious food, characterized in that: The composition comprises any one of claims 1 to 3, and a pharmaceutically acceptable adjuvant or food additive. The adjuvant comprises at least one of the following: gelatin, pectin, beeswax, glycerin, titanium dioxide, starch, dextrin, microcrystalline cellulose, cross-linked cellulose, sodium carboxymethyl starch, sodium carboxymethyl cellulose, magnesium stearate, talc and micro-powdered silica. For edible adjuvants or food additives, as food additives that can be used and meet relevant standards, they must comply with the provisions of the National Food Safety Standard for the Use of Food Additives of the People's Republic of China (GB 2760-2024).

5. The composition according to claims 1-3, characterized in that The dosage form is tablets, soft capsules, hard capsules, soft candies (candies), solid beverages, liquid beverages, and any other forms of oral consumption. The preparation method is not particularly limited, and a known method can be used.

6. The composition according to claim 5, when the dosage form is a tablet, the preparation method thereof comprises the following steps: (1) Mixing, crushing and sieving the composition according to any one of claims 1 to 3 with auxiliary materials; (2) Mix the powder and the wetting agent or adhesive to make a soft material, pass through a 20-mesh sieve to make wet granules and dry; (3) Sieve the dried granules and compress them into tablets, and monitor the hardness and quality of the tablets; (4) Film-coat the tablets and package them after quality inspection.

7. The composition according to claim 5, when the dosage form is soft candy (candy), the preparation method thereof comprises the following steps: (1) Mix the composition according to any one of claims 1 to 3 with its auxiliary materials, grind and set aside; (2) Vacuuming and degassing gelatin, glycerin, purified water and colorant sol to obtain a glue solution; (3) The mixture of step (1) is pressed with glue to form soft candy (candy), which is then dried, demoulded, and then quality inspected and packaged.

8. Applications of the composition of any one of claims 1 to 3 include, but are not limited to: enhancing memory and cognitive function, improving learning and information processing ability, resisting fatigue and enhancing physical fitness, relieving anxiety and stabilizing emotions, improving cerebrovascular health, improving sleep quality, protecting nerves and resisting aging, promoting neurotransmitter synthesis, increasing growth hormone secretion, maintaining normal brain function, and combating age-related cognitive decline, etc.