CN114010676A

CN114010676A - Composition for reducing blood fat and improving memory and preparation method thereof

Info

Publication number: CN114010676A
Application number: CN202111186208.3A
Authority: CN
Inventors: 钟茂团; 常小平; 薛雪; 何德中; 钟小莉
Original assignee: SICHUAN FENGCHUN PHARMACEUTICAL CO LTD
Current assignee: SICHUAN FENGCHUN PHARMACEUTICAL CO LTD
Priority date: 2021-10-12
Filing date: 2021-10-12
Publication date: 2022-02-08

Abstract

The invention provides a composition for reducing blood fat and improving memory and a preparation method thereof, relates to the fields of food, health care products and medicines, and aims to solve the problems of poor quality, excessive residual solvent, reduced content of effective components and the like of a product in the health care product for reducing blood fat or improving memory in the prior art due to the problems of raw materials, extraction by using a harmful solvent, overhigh temperature in a technological process and the like, so that the final product cannot well play the treatment and health care functions of reducing blood fat and improving memory. The invention mainly comprises walnut oil, soybean lecithin, ginkgo leaf extract, natural vitamins, soybean oil, beeswax, gelatin, glycerol, purified water, titanium dioxide and cocoa shell pigment, and is preferably prepared into soft capsules. The composition provided by the invention has the advantages of reasonable formula, simple and feasible process, convenience in taking, small dosage, obvious effects on improving memory and reducing blood fat, no toxic or side effect and wide application.

Description

Composition for reducing blood fat and improving memory and preparation method thereof

Technical Field

The invention relates to the fields of food, health care products and medicines, in particular to a composition for reducing blood fat and improving memory and a preparation method thereof.

Background

Hyperlipidemia is a common disease, the incidence rate of which is gradually increased, atherosclerosis can be caused, various diseases are induced, and the hyperlipidemia has serious harm to human bodies. Currently, about 9000 ten thousand people in China have hyperlipidemia, but the awareness rate is less than 25%, and people often cannot find the hyperlipidemia in time because the pathogenesis of the hyperlipidemia is a slow process. At present, most of the hyperlipidemia is treated by medicines, but because of great side effects of the medicines, more and more people need healthy lipid-lowering products without side effects.

Learning and memory are one of the high-level functions of human brain and are the main functional components of human intelligence, but with the development of society, the pressure on human beings is more and more, and many people can cause hypomnesis due to physical organic diseases or mental reasons. In addition, memory also declines with age. With the aging of the social population, the proportion of people with memory deterioration is also increasing year by year. Therefore, memory improving products with health and no side effects are also being noticed by more people.

Modern medical research shows that hyperlipidemia can cause the function damage of cerebral artery and capillary endothelial cells, reduce cerebral blood flow, reduce oxygen and nutrition supply of brain, increase the risk of cognitive dysfunction and dementia, and directly influence the neuron degeneration related to cognitive function, so that clinically, the proportion of people accompanied with hyperlipidemia in senile dementia patients is higher, and the occurrence of hyperlipidemia and dementia is also shown to have a certain correlation. Most of the patients with hyperlipidemia are accompanied by the symptoms of memory decline.

Therefore, people hope that products which are convenient to take and can reduce blood fat and improve memory can meet the requirements, and research and development of products with double functions of reducing blood fat and improving memory can be carried out as soon as possible, so that the method has important social significance.

Walnut is a plant of Juglans of Juglandaceae, and enjoys the beauty of fructus alpiniae oxyphyllae, pecan and treasure for nourishing people. The walnut oil has the essence of walnut and multiple health care and medicinal effects. The rich polyunsaturated fatty acid is a special bioactive substance, and has good health promotion and therapeutic effects on cardiovascular and cerebrovascular diseases. Guan Wei et al indicate that linoleic acid is a precursor substance for synthesizing prostaglandin by human body, and has the functions of regulating blood fat, reducing cholesterol, improving memory and the like. The Li Jian Ke et al studied the effect of walnut oil on mouse blood lipid, and as a result, the serum Triglyceride (TG), Total Cholesterol (TC) and Arteriosclerosis Index (AI) of the mice in the walnut oil test group were all lower than those in the high-lipid model group in different degrees, while the high-density lipoprotein (HDL-C) was significantly higher than those in the high-lipid model group. The results show that the walnut oil has the function of obviously reducing blood fat. The Daiyi and the like research the blood fat reducing effect of the alpha-linolenic acid and the gamma-linolenic acid on the hyperlipemia population, and the result shows that the alpha-linolenic acid and the gamma-linolenic acid have the function of assisting in reducing blood fat. Zhangqingan and the like research the influence of walnut oil on the learning and memory ability of mice, and the result shows that the walnut oil can obviously improve the learning and memory ability of the mice.

Soybean phospholipids are a generic term for various phosphoglycerides and their derivatives present in soybean, and include two major classes, glycerophospholipids and neurotropic phospholipids. The soybean lecithin has wide physiological activity, can regulate human cell membranes, keep the fluidity of vascular wall cells, prevent and treat arteriosclerosis, improve lipid metabolism, clarify blood and prevent and treat hyperlipidemia; improving and enhancing nerve function, and preventing senile dementia. The prevention effect of soybean phospholipid on rat experimental hyperlipidemia is researched by the He Xinxia and the like, when the rat eats high-fat feed, the soybean phospholipid is infused, the serum HDL-C concentration is obviously increased, and the LDL-C concentration is obviously reduced, which shows that the soybean phospholipid has the prevention effect on rat experimental hyperlipidemia. The effects of soybean phospholipids on the learning and memory of mice and the content of hippocampal fatty acid are researched by sclarerin and the like, and the results show that the learning and memory abilities of the mice in high and medium dose groups are obviously enhanced compared with those in a control group; the memory of the mice in the low-dose group is obviously improved. The result shows that the soybean lecithin can obviously improve the learning and memory ability of the mouse. Animal experiments of soybean lecithin on improving memory have been studied by battery level, etc., and the soybean lecithin has the function of improving memory.

Folium Ginkgo is dry leaf of Ginkgo biloba of Ginkgoaceae. Modern researches show that the ginkgo leaf extract has the effects of resisting platelet activating factors, resisting cerebral ischemia and anoxia, reducing blood fat, removing free radicals, relaxing bronchial smooth muscle, resisting inflammation, enhancing nervous system activity and the like, and has obvious prevention and treatment effects on diseases related to heart and cerebral vessels, such as coronary heart disease, hypertension, angina, arteriosclerosis, cerebral hypofunction, senile dementia and the like. The Zhang Qi and the like research the lipid regulating mechanism of the ginkgo leaf extract on the experimental hyperlipidemia rats, and the ginkgo leaf extract has obvious prevention and treatment effects on the experimental hyperlipidemia rats. Wu Yu et al studied the effect of ginkgo leaf extract on the learning and memory of rats, and the result showed that ginkgo leaf extract can enhance the activities of SOD and GSH-Px in ischemic brain tissues, reduce the content of MDA, remove oxygen free radicals, inhibit nerve cell apoptosis and improve the learning and memory ability of rats with vascular dementia. The research on the improvement effect of the ginkgo biloba extract on learning and memory disorders of the aged mice proves that the ginkgo biloba extract has obvious improvement effect on the learning and memory disorders of the aged mice.

Vitamin E is one of the most prominent antioxidants. It has effects in enhancing immunity, resisting oxidation, regulating blood lipid, and improving memory. The results of researches on the prevention effect of vitamin E on the hyperlipidemia of mice show that the vitamin E can reduce low-density lipoprotein, regulate the absorption rate of cholesterol and increase the excretion of lipid, thereby achieving the effect of obviously reducing the blood fat. The influence of vitamin E on blood fat of cerebrovascular diseases is researched by Wangzaihua and the like, and research results show that the vitamin E is a free radical scavenger, has an antioxidant effect and can regulate abnormal lipid metabolism. Zhaolin and the like research the influence of vitamin E on the learning and memory abilities of mice with Alzheimer disease models, and as a result, the vitamin E can prevent the damage of the learning and memory abilities of the chemically induced mice, and the mechanism is related to the improvement of SOD activity, the reduction of MDA content, the reduction of AchE activity and the like. The treatment effect of vitamin E on cognitive dysfunction of epileptic rats is researched by Xianxinhua and the like, and as a result, the vitamin E can improve the cognitive function of the rats after status epilepticus persists.

Patent documents disclose some health care products for reducing blood fat or improving memory, most of which have simple formulas and are difficult to achieve the effect of simultaneously having double functions of reducing blood fat and improving memory. For example, the Chinese patent with application number of CN201510685443.3 discloses a health food for improving memory function, the formula is prepared by using ginkgo leaf, kudzuvine root and hawthorn as main raw materials and crushing and sterilizing the raw materials, the health food has the advantages of simple process, large dosage, no function verification and safety evaluation, nominal memory improving function and no function of reducing blood fat. The invention discloses a traditional Chinese medicine composition for reducing blood fat viscosity with application number 201510234146.7, a preparation method and an application patent thereof, and discloses a preparation method of a product containing ginkgo leaf and kudzuvine root raw materials for reducing blood fat, wherein the number of the used medicinal materials is as high as 38, the formula is excessively numerous and complicated, only ginkgo leaf and kudzuvine root are used as main functional raw materials, the process is simple, the evaluation data of function and safety tests are lacked, the function of reducing blood fat is difficult to evaluate, and only the function of reducing blood fat is nominally realized, and the function of improving memory is not realized. Therefore, these products are mostly formulated products with single-side effect of improving memory or reducing blood lipid. In order to achieve the dual functions of reducing blood fat and improving memory, part of the products select a plurality of plant raw materials, for example, a Chinese medicinal composition for reducing blood fat and/or improving memory with application number of CN201810149312.7 and application thereof, the Chinese medicinal composition is composed of ginkgo leaves, kudzuvine roots, hawthorns, grape seeds, gingers and green tea or extracts of the ginkgo leaves, the kudzuvine roots, the hawthorns, the grape seeds, the gingers and the green tea, but because the Chinese medicinal composition is a plant or an extract thereof, in order to achieve a certain effect, 6 plants have to be selected, the dosage has to be extremely large, and in addition, because the grape seeds, the gingers and the green tea are materials with large tastes, the mouth feel is not good, people are unwilling to take the Chinese medicinal composition and are difficult to exert the health-care effect. In addition, some documents disclose methods for preparing walnut oil, soybean lecithin, ginkgo biloba extract and natural vitamin E, but these methods often have the problems of selecting leftovers as raw materials, using harmful solvents for extraction, high temperature in the process, and the like, and finally the problems of poor quality, excessive residual solvents, reduced content of effective components and the like of the product are caused, so that the final product cannot well play the health care and treatment effects of reducing blood fat and improving memory. In addition, the final product is not verified by a safety toxicology experiment, and the safety of the final product cannot be guaranteed.

In conclusion, in the health care products with the functions of reducing blood fat or improving memory in the prior art, some components are too simple to achieve the effect, some components are too complex, the dosage is large, the function and safety evaluation is lack, the effect is difficult to evaluate, and most of the components have single effect. Even if the individual formula is used for achieving the dual effects of reducing blood fat and improving memory, the effect is difficult to play due to too large dosage and bad taste. And problems of poor quality, excessive residual solvent, reduced content of effective components and the like can be caused finally due to some problems in the preparation process, so that the treatment and health care effects of reducing blood fat and improving memory can not be well exerted.

The traditional method for preparing the walnut oil is a hot bar method, and the method has the advantages of low oil extraction rate, severe oil oxidation and more byproducts. At present, solvent extraction is widely used, but the method has serious problems of solvent residue and the like and has poor quality. The extraction method of walnut oil with patent number CN201711109798.3 uses a relatively complex process, adds enzyme and surfactant, has more by-products and chemical residue, and is not a good method.

There are various methods for preparing soybean phospholipids, one of which is obtained by processing the byproducts generated during the preparation of soybean oil, and the quality of the obtained soybean phospholipids cannot be guaranteed because the previous processing process only concerns the yield and quality of soybean oil. In addition, there are organic solvent extraction methods and ion exchange resin methods, which may leave residues of solvents and additives. Although the traditional soybean oil pressure rod process avoids the problem of solvent residue, in order to eliminate beany flavor and other peculiar smells in the product and increase the oil yield, the soybeans are subjected to heating denaturation treatment, so that the unsaturated fatty acid, VE and the like in the soybeans are subjected to heat loss, the oil produced by the rod is deep in color and rich in impurities, the quality is influenced, and the health-care function is influenced. The membrane method extraction process of soybean lecithin with application number CN201610845460.3 also has the problems of excessive impurities because soybeans are directly extracted without being processed and the concentration of the filtrate to be filtered is not controlled well and the filtering pressure is not controlled well.

The natural vitamin E is prepared by various methods, one method is that the natural vitamin E is processed by using byproducts in the deodorization process of soybean oil preparation, and the impurities are more and the quality is poor. In addition, the organic solvent extraction method and the urea precipitation method both have residues of the solvent and the additive; it is catalyzed by zinc chloride and tetrahydropyran, however, both substances are highly toxic; in addition, distillation and rectification methods also cause problems of heat loss and increase of impurities, thereby affecting the efficacy of the method.

Aiming at the problems in the prior art, the invention selects raw materials suitable for health care products and selects a proper process, and the prepared walnut oil is pure natural, has no additive, is not oxidized and has no byproducts. The prepared soybean phospholipid has no additive, no oxidation, no by-product, no solvent and additive residue, high purity and good effect. The prepared natural vitamin E has no solvent and additive residues, no heat loss and high purity, completely retains four tocopherol components of the natural vitamin E, plays a role in synergy and exerts the health care effect to the maximum extent. According to the characteristic that the walnut oil and the natural vitamin E in the raw materials of the product are oily, a proper soft capsule formulation is preferably selected, the defects are avoided, the problems in the prior art are solved, and the prepared product has the following advantages: the absorption is fast; the content is accurate; the bioavailability is high, and the dosage of a patient is reduced; the stability is good, and moisture absorption is not easy; the sealing performance is good, and the bad smell of the medicine is covered; convenient taking, beautiful appearance and popular with people. The product obtained by the technology passes animal experiments and human body feeding experiments, and is verified by toxicological experiments, so that the product has good safety and effectiveness, can better play the roles of reducing blood fat and improving memory, and has better economic and social benefits.

Disclosure of Invention

The invention provides a composition for reducing blood fat and improving memory and a preparation method thereof, aiming at solving the problems that in the prior art, in a health-care product for reducing blood fat or improving memory, some components are too simple to achieve the effect, some components are too complex in formula, large in dosage, lack in function and safety evaluation, and difficult to evaluate the effect, but also has the problem of single effect, solves the problem that the individual formula has the double effects of reducing blood fat and improving memory, however, the dosage is too large, the taste is not good, the function is difficult to play, the problems of poor quality, excessive residual solvent, reduced content of effective components and the like of the product are caused by selecting leftovers as raw materials, using harmful solvent for extraction, over-high temperature in the process, and the like, so that the final product cannot well play the treatment and health care functions of reducing blood fat and improving memory.

The technical scheme of the invention is as follows:

the invention provides a composition for reducing blood fat and improving memory, which is mainly prepared from walnut oil, soybean lecithin, a ginkgo leaf extract and natural vitamin E as raw materials, and proper auxiliary materials through a scientific and reasonable production process, so that the functional effects of reducing blood fat and improving memory are achieved, wherein the auxiliary materials are soybean oil, beeswax, gelatin, glycerol, purified water, titanium dioxide and cocoa shell pigment.

The preferred dosage form of the invention is a soft capsule.

The composition comprises, by weight, 300 parts of walnut oil and 340 parts of soybean lecithin, 55-65 parts of soybean lecithin, 20-24 parts of ginkgo leaf extract and 5.6-6.6 parts of natural vitamin E; the auxiliary materials comprise 180 parts of 170-180 parts of soybean oil, 16-18 parts of beeswax, 540 parts of gelatin, 230 parts of glycerol 210, 500 parts of purified water 460, 1.7-1.9 parts of titanium dioxide and 0.75-0.85 part of cocoa shell pigment in parts by weight.

Preferably, the formula proportion of the composition comprises, by weight, 320 parts of walnut oil, 60 parts of soybean lecithin, 22 parts of ginkgo biloba extract, 6 parts of natural vitamin E, 175 parts of soybean oil, 17 parts of beeswax, 520 parts of gelatin, 220 parts of glycerol, 480 parts of purified water, 1.8 parts of titanium dioxide and 0.8 part of cocoa shell pigment.

The preparation method of the composition for reducing blood fat and improving memory comprises the following steps:

(1) mixing the walnut oil and the soybean oil, stirring to mix uniformly, heating to 70-80 ℃, adding beeswax to completely melt the beeswax, and stirring to mix uniformly to obtain an oil-wax mixed solution;

(2) adding the ginkgo leaf extract, soybean lecithin and natural vitamin E into the oil-wax mixed solution in the step (1), stirring for 30min, processing for 3 times by a colloid mill, filtering by a 100-mesh filter screen, and vacuumizing and defoaming under the condition of vacuum degree of-0.06 Mpa to obtain capsule core feed liquid;

(3) adding purified water into a gelatin melting tank, heating to 60 deg.C, adding gelatin and glycerol, heating to 70 deg.C, stirring to obtain uniform gelatin solution, adding cocoa shell pigment and titanium dioxide, stirring, mixing, maintaining the temperature for 2 hr, vacuumizing under vacuum degree of-0.06 Mpa for removing bubbles, filtering with 100 mesh filter screen to obtain capsule shell gelatin solution, and keeping at 60-65 deg.C;

(4) taking the capsule core material liquid and the capsule shell glue liquid, pelleting by a pelleting machine to prepare 0.6 g/capsule, shaping the capsule at the temperature of 18-26 ℃ and the humidity of 30-40%, then washing the capsule by 95% ethanol, drying the washed capsule at the temperature of 20-25 ℃ and the humidity of 20-30%, picking out unqualified capsules such as flat capsule, oil leakage pill and the like, and packaging the qualified capsules into 90 capsules/bottle to obtain the finished soft capsule.

Wherein:

the extraction method of walnut oil comprises removing shell from walnut to obtain walnut kernel, cleaning walnut kernel, drying, pulverizing into coarse particles with diameter of 0.2-0.6 cm, cold pressing directly with cold pressing type oil press under 28-38MPa to obtain walnut oil, standing walnut oil for 18-24 hr, collecting supernatant, centrifuging at 2600 and 3200 rpm with high-speed centrifuge, collecting supernatant, filtering with 80-200 mesh filter screen, removing filter residue, and bottling filtrate to obtain walnut oil product.

The more excellent walnut oil extraction method comprises the steps of removing shells of walnut fruits with good quality to obtain walnut kernels, cleaning the walnut kernels, drying, crushing into coarse particles with the diameter of 0.3-0.5 cm, directly cold-pressing by adopting a cold-pressing type oil press at the pressure of 28-38MPa to obtain walnut oil, standing the walnut oil for 18-24 hours, taking supernate, centrifuging at the rotating speed of 2600 plus materials per minute by using a high-speed centrifuge, taking supernate, filtering by using a 100-mesh filter screen, removing filter residues, filling filtrate to obtain the walnut oil product.

The extraction method of soybean phospholipid comprises selecting mature and full high-quality soybean with uniform size, cleaning with clear water, placing into an oven, drying at 50-70 deg.C, pulverizing into fine powder with an ultrafine pulverizer, adding 10% cellulase solution with soybean powder weight ratio of 2.0-4.0%, adding water 1 times volume of the soybean powder, stirring, keeping at 45-60 deg.C for 1-2 hr, adding water 2.5-3.5 times volume of the soybean powder, stirring, filtering with 40-70 mesh screen, removing large granule impurities, adding the remaining solution into nanofiltration membrane, performing nanofiltration under 0.75-0.95MPa, collecting filtrate, and concentrating under reduced pressure at 65-78 deg.C to obtain soybean phospholipid product.

The more excellent extraction method of soybean phospholipid comprises the steps of selecting mature and full high-quality soybeans with uniform size, cleaning the soybeans with clear water, putting the soybeans into an oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into fine powder by using an ultrafine crusher, adding a 10% cellulase solution with the weight ratio of 2.5-3.3% of the soybean powder, adding 1 time volume of water of the soybean powder, stirring the mixture uniformly, keeping the temperature at the temperature of 45-60 ℃ for 1-2 hours, adding 3 times volume of water of the soybean powder into the solution, stirring the mixture uniformly, filtering the mixture by using a 60-mesh screen, removing large-particle impurities, adding the remained solution into a nanofiltration membrane, performing nanofiltration by adopting the pressure of 0.80-0.90MPa, collecting filtrate, and performing reduced pressure concentration at the temperature of 68-75 ℃ to obtain a finished product.

The preparation method of the ginkgo leaf extract comprises the steps of selecting clean and impurity-free ginkgo leaves, adding 70% ethanol in an amount which is 2.5-3.5 times of the amount of the ginkgo leaves, carrying out reflux extraction for 1-2 hours, filtering, combining filtrate, recovering ethanol, adding water in an amount which is 1.3-1.8 times of the amount of the ginkgo leaves, uniformly stirring, centrifuging, filtering supernate, enabling the filtrate to pass through a macroporous adsorption resin column, keeping the filtrate higher than resin, keeping for 2-4 hours, washing with 2.5-3.5 times of the amount of the ginkgo leaves, eluting with 65-75% ethanol in an amount which is 3.5-4.5 times of the amount of the ginkgo leaves, collecting 65-75% ethanol eluent, recovering ethanol, concentrating to extract liquid with the relative density of 1.06-1.14, carrying out spray drying to obtain dry extract powder, crushing and sieving to obtain the ginkgo leaf extract.

The more preferable ginkgo leaf extract is prepared by selecting clean and impurity-free ginkgo leaves, adding 70% ethanol of 3 times of the ginkgo leaves, carrying out reflux extraction for 2 hours, filtering, combining filtrates, recovering ethanol, adding water of 1.5 times of the ginkgo leaves, uniformly stirring, centrifuging, filtering supernatant, passing the filtrate through a macroporous adsorption resin column, keeping the filtrate higher than resin for 3 hours, washing with 3 times of the ginkgo leaves, eluting with 4 times of 70% ethanol of the ginkgo leaves, collecting 70% ethanol eluate, recovering ethanol, concentrating to obtain extract liquid with the relative density of 1.08-1.12, carrying out spray drying to obtain dry extract powder, crushing, and sieving to obtain the ginkgo leaf extract.

The preparation method of the natural vitamin E comprises the steps of selecting mature, full and uniform high-quality soybeans, cleaning the soybeans with clear water, putting the soybeans into a drying oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into coarse powder passing through a 40-80-mesh screen, directly cold pressing the coarse powder by using a cold pressing type oil press under the pressure of 32-50MPa, pressing the coarse powder to remove oil, discarding the oil, adding 1.3-1.8 times of water into the solid materials after oil removal, uniformly stirring and mixing the mixture, putting the mixture into a wiped film evaporator, evaporating the mixture under the vacuum degree of-0.06-0.08 MPa to remove water and volatile substances in the solid materials, adding 2 times of ethanol into the treated oily materials, uniformly stirring and mixing the mixture, taking potassium sorbate with the weight of 0.035-0.045% of the oily materials and liquid maltitol with the weight of 0.045-0.065% of the oily materials as materials A, taking 54-68% ethanol water solution 5-8 times of the total weight of the material A as a material B, slowly adding the material B into the material A under the condition of continuous stirring, then fully stirring to uniformly mix the material A and the material B, taking the material C as a material C, slowly adding the material C into the oily matter under the condition of continuous stirring, stirring at room temperature for 15-25 minutes to fully mix the material C, standing for 20-28 hours, filtering through a 60-100 mesh screen, adding 0.8-1.2 times of ethanol into the filter residue to dissolve the filter residue, adding 0.08-0.12 times of 8-12% acetic acid water solution into the filter residue, stirring and mixing uniformly, heating to 45-55 ℃, keeping the temperature and stirring for 1.5-2.5 hours, standing for 20-28 hours, filtering through a 80-160 mesh screen, evaporating and concentrating the filtrate under the condition of vacuum degree of-0.04-0.08 MPa, obtaining the natural vitamin E product.

The more excellent natural vitamin E is prepared by selecting mature, full and uniform high-quality soybeans, cleaning the soybeans with clear water, putting the soybeans into an oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into coarse powder passing through a 60-mesh screen, directly cold-pressing the coarse powder by using a cold-pressing oil press under the pressure of 36-46MPa to remove oil, discarding the oil, adding 1.5 times of water into the solid materials after oil removal, uniformly stirring and mixing the mixture, putting the mixture into a wiped film evaporator, evaporating the mixture under the vacuum degree of-0.07 MPa to remove water and volatile substances in the wiped film evaporator, adding 2 times of ethanol into the treated oily matter, uniformly stirring and mixing the ethanol, taking potassium sorbate with the weight of 0.038-0.042% of the oily matter and liquid maltitol with the weight of 0.052-0.059% of the oily matter as a material A, taking 58-63% of ethanol aqueous solution with the weight of 5.5-7.5 times of the total weight of the material A as a material A, and as a material B, slowly adding the material B into the material A under the condition of continuous stirring, fully stirring again to uniformly mix the material A and the material B, as a material C, slowly adding the material C into the oily matter under the condition of continuous stirring, stirring at room temperature for 18-22 minutes to fully mix, standing for 24 hours, filtering through 80 meshes, adding 1 time of ethanol into the filter residue to dissolve the filter residue, adding 0.1 time of 10% acetic acid aqueous solution into the filter residue, stirring uniformly, heating to 45-55 ℃, keeping the temperature for stirring for 2 hours, standing for 24 hours, filtering through 100 meshes, and evaporating and concentrating the filtrate under the condition of vacuum degree of-0.06 Mpa to obtain the natural vitamin E product.

The composition for reducing blood fat and improving memory provided by the invention is used for preparing food and health-care products acceptable oral preparations, including but not limited to soft capsules, granules, tablets, pills, oral liquid and the like.

The composition for reducing blood fat and improving memory is applied to medicines, foods or health-care products for improving memory and reducing blood fat.

One or more or all of walnut oil, soybean lecithin, ginkgo leaf extract and natural vitamin E used by the invention can be prepared by self or purchased from the market.

The invention has the beneficial effects that:

the composition for reducing blood fat and improving memory provided by the invention has the advantages of reasonable formula, simple and feasible process, convenience in taking, small dosage, obvious effects on improving memory and reducing blood fat, no toxic or side effect and wide application.

The invention well solves the problems of the prior art, and the prepared walnut oil is pure natural, has no additive, no oxidation and no by-product; the prepared soybean phospholipid has no additive, no oxidation, no by-product, no solvent and additive residue, high purity and good effect; the prepared natural vitamin E has no solvent and additive residues, no heat loss and high purity, completely retains four tocopherol components of the natural vitamin E, plays a role in synergy and exerts the health care effect to the maximum extent; by the advantages, the product produced by the technology is pure natural, high in purity and free of pollution, and meets the requirements of people on pursuing naturalness and health at present. The preferred dosage form soft capsule of the technology is most suitable for the characteristics of a plurality of oily components of the technology, and the prepared product has the following advantages: the absorption is fast; the content is accurate; the bioavailability is high, and the dosage of a patient is reduced; the stability is good, and moisture absorption is not easy; the sealing performance is good, and the bad smell of the medicine is covered; convenient taking, beautiful appearance and popular with people. The product obtained by the technology passes animal experiments and human body feeding experiments, and is verified by toxicological experiments, so that the product has good safety and effectiveness, and the effects of reducing blood fat and improving memory of the product can be better played. After the technology is popularized and applied, hyperlipidemia can be well prevented, and the problems that atherosclerosis is caused and various diseases are induced due to the gradual rise of the incidence rate of hyperlipidemia are solved. Can solve the problem of hypomnesis and reduce the risk of cognitive dysfunction and dementia. The results are helpful for improving the health and life quality of the masses, and have good economic and social benefits.

Detailed Description

The following are specific embodiments of the present invention, which are intended to further illustrate the invention and not to limit it.

Example 1

A composition for reducing blood fat and improving memory is prepared by taking corresponding materials according to the following formula proportion: 320 parts of walnut oil, 60 parts of soybean lecithin, 22 parts of ginkgo leaf extract, 6 parts of natural vitamin E, 175 parts of soybean oil, 17 parts of beeswax, 520 parts of gelatin, 220 parts of glycerol, 480 parts of purified water, 1.8 parts of titanium dioxide and 0.8 part of cocoa shell pigment.

The preparation method comprises the following steps of preparing walnut oil, soybean lecithin, a ginkgo leaf extract and natural vitamin E according to the following technical scheme:

extracting walnut oil: removing the shell of walnut to obtain walnut kernel, cleaning walnut kernel, drying, pulverizing into coarse granules with diameter of 0.3-0.5 cm, directly cold-pressing by using cold-pressing oil press at 28-38MPa to obtain walnut oil, standing walnut oil for 18-24 hr, taking supernatant, centrifuging at 2600 and 3200 rpm by using high-speed centrifuge, taking supernatant, filtering by using 100-mesh filter screen, removing filter residue, and filling filtrate to obtain walnut oil product.

Extracting soybean lecithin: selecting mature and full high-quality soybeans with uniform size, cleaning the soybeans with clear water, putting the soybeans into an oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into fine powder by using an ultrafine crusher, adding 10% of cellulase solution with the weight ratio of the soybean powder being 2.8-3.5%, adding 1 time volume of water, uniformly stirring the mixture, preserving the heat at the temperature of 45-60 ℃ for 1-2 hours, adding 2 times volume of water into the solution, uniformly stirring the mixture, filtering the mixture by using a 60-mesh screen to remove large-particle impurities, adding the remained solution into a nanofiltration membrane, performing nanofiltration by using the pressure of 0.75-0.95MPa, collecting filtrate, and performing reduced pressure concentration at the temperature of 65-78 ℃ to obtain a finished product of soybean lecithin.

Preparing a ginkgo leaf extract: selecting clean and impurity-free ginkgo leaves, adding 70% ethanol in an amount which is 3 times that of the ginkgo leaves, carrying out reflux extraction for 2 hours, filtering, combining filtrates, recovering ethanol, adding 1.5 times of water by volume, uniformly stirring, centrifuging, filtering supernate, passing the filtrate through a macroporous adsorption resin column, keeping the filtrate higher than the resin for 3 hours, then washing with 3 times of water, eluting with 4 times of 70% ethanol, collecting 70% ethanol eluent, recovering ethanol, concentrating to obtain extract liquid with the relative density of 1.08-1.12, carrying out spray drying to obtain dry extract powder, crushing, and sieving to obtain the ginkgo leaf extract.

Preparing natural vitamin E: selecting mature, full and uniform high-quality soybeans, cleaning the soybeans with clear water, putting the soybeans into an oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into coarse powder passing through a 60-mesh screen, directly cold pressing the coarse powder by using a cold pressing type oil press under the pressure of 36-46MPa to remove oil and fat, discarding the oil and fat, adding 1.5 times of water into the solid materials after oil removal, uniformly stirring and mixing the mixture, putting the mixture into a wiped film evaporator, evaporating the mixture under the vacuum degree of-0.07 MPa to remove water and volatile substances in the evaporated mixture, adding 2 times of ethanol into the treated oily materials, uniformly stirring and mixing the mixture, taking potassium sorbate with the weight of 0.039% of the oily materials and liquid maltitol with the weight of 0.058% of the oily materials as a material A, taking a 60% of ethanol aqueous solution with the weight of 6.5 times of the total weight of the material A as a material B, slowly adding the material B into the material A under the condition of continuous stirring, and then fully stirring to uniformly mix the material A and the material B, taking the mixture as a material C, slowly adding the material C into the oily matter under the condition of continuous stirring, stirring for 20 minutes at room temperature to fully mix the materials uniformly, standing for 24 hours, filtering through a 80-mesh sieve, adding 1 time of ethanol into filter residues to dissolve the filter residues, adding 0.1 time of 10% acetic acid aqueous solution, stirring and uniformly mixing, heating to 45-55 ℃, keeping the temperature and stirring for 2 hours, standing for 24 hours, filtering through a 100-mesh sieve, and evaporating and concentrating the filtrate under the condition of vacuum degree of-0.06 Mpa to obtain the natural vitamin E product.

Preparing the soft capsule:

mixing oleum Juglandis and soybean oil, stirring, heating to 70-80 deg.C, adding Cera flava to melt Cera flava completely, and stirring to obtain mixed solution of oil and wax. Adding folium Ginkgo extract, soybean phospholipid, and natural vitamin E into the above oil and wax mixed solution, stirring for 30min, processing with colloid mill for 3 times, filtering with 100 mesh filter screen, and removing bubbles under vacuum degree of-0.06 Mpa to obtain capsule core material liquid.

Adding purified water into gelatin melting tank, heating to 60 deg.C, adding gelatin and glycerol, heating to 70 deg.C, stirring to obtain uniform gelatin solution, adding cocoa shell pigment and titanium dioxide, stirring, mixing, maintaining the temperature for 2 hr, vacuumizing under-0.06 Mpa, removing bubbles, filtering with 100 mesh filter screen to obtain capsule shell gelatin solution, and keeping at 60-65 deg.C.

Making into capsule with the above capsule core material solution and capsule shell glue solution by pill making machine to obtain capsule of 0.6 g/capsule, shaping at 18-26 deg.C and humidity of 30-40%, washing with 95% ethanol, drying at 20-25 deg.C and humidity of 20-30%, picking out unqualified capsule such as flat capsule and oil leakage pill, and packaging into 90 capsules/bottle to obtain the final product.

Example 2

A composition for reducing blood fat and improving memory is prepared by taking corresponding materials according to the following formula proportion: 300 parts of walnut oil, 65 parts of soybean phospholipid, 20 parts of ginkgo leaf extract, 5.6 parts of natural vitamin E, 170 parts of soybean oil, 16 parts of beeswax, 500 parts of gelatin, 210 parts of glycerol, 500 parts of purified water, 1.9 parts of titanium dioxide and 0.75 part of cocoa shell pigment.

The walnut oil, the soybean lecithin and the ginkgo leaf extract are prepared according to the following technical scheme:

Extracting soybean lecithin: selecting mature and full high-quality soybeans with uniform size, cleaning the soybeans with clear water, putting the soybeans into an oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into fine powder by using an ultrafine crusher, adding 10% of cellulase solution with the weight ratio of the soybean powder being 2.0-3.0%, adding water with the volume being 1 time of the soybean powder, uniformly stirring the mixture, preserving the heat at the temperature of 45-60 ℃ for 1-2 hours, adding water with the volume being 2 times of the soybean powder into the solution, uniformly stirring the mixture, filtering the mixture by using a 60-mesh screen, removing large-particle impurities, adding the remaining solution into a nanofiltration membrane, performing nanofiltration by using the pressure of 0.75-0.95MPa, collecting filtrate, and performing reduced pressure concentration at the temperature of 65-78 ℃ to obtain a finished product of soybean lecithin.

Preparing a ginkgo leaf extract: selecting clean and impurity-free ginkgo leaves, adding 70% ethanol in an amount which is 2.5 times that of the ginkgo leaves, carrying out reflux extraction for 2 hours, filtering, combining filtrate, recovering ethanol, adding water in an amount which is 1.5 times that of the ginkgo leaves, uniformly stirring, centrifuging, filtering supernatant, passing the filtrate through a macroporous adsorption resin column, keeping the filtrate higher than the resin for 2 hours, washing with 2.5 times that of the ginkgo leaves, eluting with 75% ethanol in an amount which is 4.5 times that of the ginkgo leaves, collecting 75% ethanol eluent, recovering ethanol, concentrating to obtain extract liquid with the relative density of 1.08-1.12, carrying out spray drying to obtain dry extract powder, crushing, and sieving to obtain the ginkgo leaf extract.

Preparing natural vitamin E: selecting mature, full and uniform high-quality soybeans, cleaning the soybeans with clear water, putting the soybeans into an oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into coarse powder passing through a 80-mesh screen, directly cold pressing the coarse powder by using a cold pressing type oil press under the pressure of 36-46MPa to remove oil and fat, discarding the oil and fat, adding 1.8 times of water to the solid materials after oil removal, uniformly stirring and mixing the mixture, putting the mixture into a wiped film evaporator, evaporating the mixture under the vacuum degree of-0.08 MPa to remove water and volatile substances in the mixture, adding 2 times of ethanol to the treated oily materials, uniformly stirring and mixing the mixture, taking potassium sorbate with the weight of the oily materials being 0.041% and liquid maltitol with the weight of 0.062% as a material A, taking 58% of ethanol aqueous solution with the weight of 5.5 times of the total weight of the material A as a material B, and continuously stirring the mixture, slowly adding the material B into the material A, fully stirring to uniformly mix the material A and the material B, taking the material B as a material C, slowly adding the material C into the oily matter under the condition of continuous stirring, stirring for 22 minutes at room temperature to fully and uniformly mix, standing for 28 hours, filtering by a 100-mesh sieve, adding 1.2 times of ethanol into filter residue to dissolve the filter residue, adding 0.12 times of 12% acetic acid aqueous solution, uniformly stirring and mixing, heating to 45-55 ℃, keeping the temperature and stirring for 2.5 hours, standing for 28 hours, filtering by a 160-mesh sieve, and evaporating and concentrating the filtrate under the condition of vacuum degree of-0.08 MPa to obtain the natural vitamin E product.

Preparing the soft capsule:

mixing oleum Juglandis and soybean oil, stirring, heating to 70-80 deg.C, adding Cera flava to melt Cera flava completely, and stirring to obtain mixed solution of oil and wax. Adding folium Ginkgo extract, soybean phospholipid, and natural vitamin E into the above oil and wax mixed solution, stirring for 30min, processing for 3 times by colloid mill, filtering with 100 mesh filter screen, and removing bubbles under vacuum degree of-0.06 Mpa to obtain capsule core material liquid;

adding purified water into a gelatin melting tank, heating to 60 deg.C, adding gelatin and glycerol, heating to 70 deg.C, stirring to obtain uniform gelatin solution, adding cocoa shell pigment and titanium dioxide, stirring, mixing, maintaining the temperature for 2 hr, vacuumizing under vacuum degree of-0.06 Mpa for removing bubbles, filtering with 100 mesh filter screen to obtain capsule shell gelatin solution, and keeping at 60-65 deg.C;

Example 3

A composition for reducing blood fat and improving memory is prepared by taking corresponding materials according to the following formula proportion: 340 parts of walnut oil, 55 parts of soybean phospholipid, 24 parts of ginkgo leaf extract, 6.6 parts of natural vitamin E, 180 parts of soybean oil, 18 parts of beeswax, 540 parts of gelatin, 230 parts of glycerol, 460 parts of purified water, 1.7 parts of titanium dioxide and 0.85 part of cocoa shell pigment.

Preparing a soft capsule: mixing oleum Juglandis and soybean oil, stirring, heating to 72-78 deg.C, adding Cera flava to melt Cera flava completely, and stirring to obtain mixed solution of oil and wax. Adding folium Ginkgo extract, soybean phospholipid, and natural vitamin E into the above oil and wax mixed solution, stirring for 25min, processing by colloid mill for 3 times, filtering with 100 mesh filter screen, and removing bubbles under vacuum degree of-0.05 Mpa to obtain capsule core material liquid;

adding purified water into gelatin melting tank, heating to 58 deg.C, adding gelatin and glycerol, heating to 68 deg.C, stirring to obtain uniform gelatin solution, adding cocoa shell pigment and titanium dioxide, stirring, mixing, maintaining the temperature for 2.5 hr, vacuumizing under vacuum degree of-0.05 Mpa for removing bubbles, filtering with 100 mesh filter screen to obtain capsule shell gelatin solution, and keeping the temperature at 61-66 deg.C;

making into capsule with the above capsule core material solution and capsule shell glue solution by pill making machine to obtain capsule of 0.6 g/capsule, shaping at 20-28 deg.C and humidity of 35-45%, washing with 95% ethanol, drying at 23-29 deg.C and humidity of 22-32%, and packaging into 90 capsules/bottle.

Example 4

A composition for reducing blood fat and improving memory is prepared by taking corresponding materials according to the following formula proportion: 320 parts of walnut oil, 75 parts of soybean lecithin, 25 parts of ginkgo leaf extract, 6 parts of natural vitamin E, 180 parts of soybean oil, 100 parts of glycerol, 600 parts of purified water, 10 parts of almond essence and 5 parts of sodium cyclamate.

Mixing oleum Juglandis, soybean oil and glycerol, stirring, heating to 75-85 deg.C, adding Cera flava to melt Cera flava completely, and stirring to obtain mixed solution of oil and wax. Adding folium Ginkgo extract, soybean phospholipid, and natural vitamin E into the above mixed solution, stirring for 25min, processing with colloid mill for 3 times, and filtering with 100 mesh filter screen to obtain mixed solution A.

Adding purified water into semen Armeniacae amarum essence and sodium cyclamate, stirring for 25min to dissolve and mix well to obtain mixed solution B.

Adding the mixed solution B into the mixed solution A, stirring for 25min to uniformly mix the two mixed solutions, and subpackaging into 100 ml/bottle to obtain the finished product.

Experiment 1: the composition of the invention has the function of reducing blood fat, and is observed in human body test feeding experiments

In order to verify the blood fat reducing effect of the composition, the inventor conducts human body feeding experiments to show that the composition has the blood fat reducing effect and has no toxic or side effect, and the report is as follows.

1. Materials and methods

Capsules No. 1 and No. 2, which have substantially the same appearance and taste, wherein No. 1 is the composition capsule prepared by the invention, and No. 2 is a placebo. The recommended dose for oral administration to human is 3 times daily, 3 granules each time.

2. Design and grouping of experiments

The test subject is not limited in sex, the test subject is 18-65 years old, blood is collected twice within half a year, the total cholesterol in serum of the two times is more than or equal to 5.2mmol/L or the triglyceride in serum of the two times is more than or equal to 1.65mmol/L, and the test subject is simple in dyslipidemia and has no obvious diseases of brain, heart, liver, lung, kidney and blood and no long-term medicine taking history. Two control designs, self and group, were used. The blood lipid levels of the subjects are randomly divided into a composition capsule test feeding group and a placebo control group, and main factors influencing the results, such as age, sex, diet and the like, are considered as much as possible to carry out balance test so as to ensure comparability among the groups. The test eating was performed by the double-blind method.

3. Test method

The subjects took the samples at the recommended dose daily for 45 consecutive days. The original diet habit was not changed during the test period, and the diet was normal.

4. Results

See tables 1, 2, 3. Blood is collected twice in half a year, which is respectively the blood fat data before 1 and 2, and the blood fat level of 2 before the test sample is taken is grouped and counted according to the date. The serum CHOL and TG levels of the control group and the test group are compared before the test, the difference is not significant (P >0.05), and the comparability between the two groups is suggested. Compared with CHOL and TG after the test feeding of the test feeding group and before the test feeding and after the test feeding of the control group, the differences are significant (P is less than 0.05). HDL-C levels did not change significantly before and after the test (P > 0.05).

TABLE 1 serum CHOL, TG, HDL-C levels prior to feeding trials

TABLE 2 serum CHOL, TG, HDL-C levels before and after the feeding trial

Note: comparison of P <0.05 # with control group before test feeding

TABLE 3 serum CHOL, TG, HDL-C changes before and after tasting

Index (I)	Control group	Test food group
			TG reduction (%)	1.56	16.25
CH0L decrease (%)	0.75	10.57
			HDL-C increase value (mmol/L)	0.01	0.05

The human body test results show that after the subject continuously takes the composition capsule for 45 days, the memory scale of the test group and the memory quotient are improved compared with the control group and the sample taken by the subject, and the difference is significant (P is less than 0.05). According to the evaluation standard of health food inspection and evaluation technical specification (2003 edition), the composition capsule provided by the invention is suggested to have the effect of assisting in improving the memory function (adults).

Experiment 2: human body test food experimental observation for improving memory effect of composition of the invention

In order to verify the memory improving effect of the composition, the inventor conducts human body feeding test, and shows that the composition has the memory improving effect and has no toxic or side effect, and the report is as follows.

1. Materials and methods

Capsules No. 1 and No. 2, which are substantially identical in packaging, appearance, color and mouthfeel, one of which is a capsule of the composition of the present invention and the other is a placebo. The recommended dose is 3 times daily, 3 capsules each time.

2. Design and grouping of experiments

The subjects were 18-65 years old, with no restriction. The health condition is good, no obvious diseases of brain, heart, liver, lung, kidney and blood exist, and no long-term history of taking medicine exists; similar tests (memory quotient and intelligence quotient tests) are not received, medicines or health-care foods related to memory improvement are not taken within one year, and the cooperation is voluntarily guaranteed by the test.

A control, double-blind and random design method is adopted. The first test is carried out before taking the sample, the sample is randomly divided into a test food group and a control group according to memory quotient, the balance of main factors influencing the result, such as culture level, age and the like, is considered as much as possible to ensure comparability among the groups, and after the balance of the two groups of memory quotient is checked, one group is randomly selected to be the test food group, and the other group is the control group.

3. Test method

The test group and the control group take samples according to the recommended dosage. The special person is responsible for taking samples and supervising administration. Health food or medicine related to memory improvement is not taken during the feeding period, and memory quotient or intelligence quotient test which is not related to the test is not participated. A second test was performed 45 days after the continuous sample.

Testing using a clinical memory scale, testing the original score scale with each score after testing: pointing memory, association learning, free image memory, meaningless figure recognization and portrait feature association memory. And adding the test scale points to obtain a total scale point, and checking the memory quotient by using the total scale point.

A magnetic tape recording guide words and stimulating words pointing to memory and associative learning; picture material, picture freely remembering object picture, two groups are 15 pieces each, 30 pieces total (divided into two groups A and B); re-recognizing pictures with meaningless figures, namely 20 pictures of target stimulation for first presentation, and 40 pictures of target stimulation for second re-recognition and 20 pictures of mixed stimulation pictures respectively, wherein the total number of the pictures is 60 (divided into two sets of pictures A and B); the portrait characteristics are related to the recall picture, 6 human faces are sketched in black and white for the first presentation, and 6 human faces are presented for the second recall, wherein the contents of the human faces and the human faces are the same, and the sequence is different, and the total number of the human faces is 12; the back of each portrait picture is marked with the characteristics of the portrait, such as surname, occupation, hobby and the like (divided into two sets, namely A and B). Recorder, stopwatch, recording paper.

The front and back tests of each subject are carried out by the same main tester; and reducing the system error. And (3) testing time point: the test of each subject is carried out at the same time point, so as to avoid the influence of biological rhythm. And in the second test, the main tester does not see the grouping list and tests in a blind method.

Testing the subject in a quiet room by trained personnel; except for the subject and the main tester, the presence of other people is avoided as much as possible; three sub-tests related to vision are arranged in the scale, and indoor light must ensure that a clear stimulating picture can be seen; the influence on memory performance caused by poor hearing or eyesight is eliminated as much as possible; attention must be paid to the mental state of the subject, and the test is carried out under the conditions that the subject is normal in mood, does not object to the test and is relatively concentrated in attention; whether the subject is tired, whether the attention is concentrated, whether the test is matched, whether the test is tense or not, whether the test is confident or not and the like are recorded on the first page of the recording paper; the test of the same subject requires to be finished at one time; in comparing the score test results with the age scale scores, care must be taken as to whether different tests are performed under the same mental state. The original score of each score test result can be filled in the original score without error.

4. Data statistics

The test data is measured data, and two groups of test amount and memory quotient can be analyzed by t test. The self-contrast can be subjected to paired t test, parallel comparison between groups is carried out by t test of mean of two samples, the latter needs to be subjected to homogeneity of variance test, appropriate variable conversion is carried out on data with non-normal distribution or uneven variance, and after the normal distribution or the uniform variance is met, t test is carried out on the converted data; if the converted data can not meet the requirement of normal variance, the t' test or the rank sum test is adopted; but data with too large a coefficient of variation (e.g., CV > 50%) apply rank-sum tests. And performing statistics by using INSTAT and SPSS statistical software.

5. Test results

As can be seen from Table 4, the directed memory amount of the test group before the sample administration was compared with the control group, and the difference was not significant (P > 0.05); after the sample is taken, the directional memory content of the test group is compared with that of the control group and the test group before the sample is taken, and the difference is significant (P is less than 0.05).

TABLE 4 Effect of the composition capsules of the invention on the pointing memory Scale

Group of	Before testing	After the test
			Control group	23.11±6.75	23.21±6.22
Test food group	23.00±7.51	24.34±5.16

As can be seen from Table 5, the associative study content of the test group before the sample administration was compared with the control group, and the difference was not significant (P > 0.05); the association study amount of the test group after the sample is taken is compared with that of the control group and the test group before the sample is taken, and the difference is not significant (P is more than 0.05).

TABLE 5 Effect of the composition capsules of the invention on associative learning scale

As can be seen from Table 6, the image free recall ratio of the test group before the sample was taken was compared with the control group, and the difference was not significant (P > 0.05); the image free memory scale of the test food group after the sample is taken is compared with that of the control group and the test food group before the sample is taken, and the difference is not significant (P is more than 0.05).

TABLE 6 Effect of capsules of the composition of the invention on the image free recall scale

Group of	Before testing	After the test
			Control group	10.51±6.52	11.64±6.32
Test food group	10.79±5.23	12.62±6.13

As can be seen from Table 7, the meaningless graph reconsideration scores of the test-eating group before the sample was taken were compared with the control group, and the difference was not significant (P > 0.05); the meaningless graph reconsideration amount of the test food group after the sample is taken is compared with that of the control group and the test food group before the sample is taken, and the difference is not significant (P is more than 0.05).

TABLE 7 Effect of capsules of the compositions of the present invention on the meaningless graphical recognizability of the fraction

Group of	Before testing	After the test
			Control group	14.02±4.09	14.25±3.47
Test food group	13.98±4.43	14.70±4.25

As can be seen from Table 8, the human image characteristics of the test group before the sample administration are compared with the recall amount and the control group, and the difference is not significant (P is more than 0.05); the human image characteristics of the test group after the sample is taken are compared with the memory scale before the sample is taken with the contrast group and the sample is taken, and the difference is not significant (P is more than 0.05).

TABLE 8 influence of the composition capsules of the invention on the human image characteristics in relation to the recall scale scores

Group of	Before testing	After the test
			Control group	18.04±6.99	18.23±6.66
Test food group	18.81±6.88	19.66±7.51

As can be seen from Table 9, the difference between the memory quotient of the test group before the sample administration and the control group is not significant (P > 0.05); the difference between the memory quotient of the test-eating group after the sample is taken and the memory quotient of the control group and the group before the sample is taken is significant (P < 0.05).

TABLE 9 Effect of the inventive composition capsules on memory quotient

Group of	Before testing	After the test
			Control group	81.02±14.70	84.62±15.00
Test food group	81.00±15.47	90.62±13.27

The human body test results show that after the subject continuously takes the composition capsule for 45 days, the memory scale of the test group and the memory quotient are improved compared with the control group and the sample before the test group takes the sample, and the difference is significant (P is less than 0.05). According to the evaluation standard of health food inspection and evaluation technical specification (2003 edition), the composition capsule provided by the invention is suggested to have the effect of assisting in improving the memory function (adults).

Experiment 3: toxicological safety observations of the compositions of the invention

To verify the safety of the composition of the present invention, the inventors have conducted safety toxicology experiments, which show that it is safe and has no toxic side effects, and the following reports are reported.

Acute oral toxicity test, three genetic toxicity tests (Ames test, mouse myeloadephagia polycythemia micronucleus test and mouse teratospermia test), 30-day feeding test, and the conclusion of the test in health food inspection and evaluation technical specification (2003 edition):

the following toxicological tests were carried out in the laboratory on the capsules of the composition according to the invention, the results being as follows:

1. acute oral toxicity test: the Maximum Tolerated Dose (MTD) of female and male mice of Kunming species is more than 18.72g/kg bw, belonging to nontoxic grade.

2. Three genotoxicity tests: the Ames test, mouse marrow pleochromocyte micronucleus test and mouse sperm malformation test result are all negative.

3. Feeding test for 30 days: the samples are added into the feed for feeding rats for 30 days according to the proportion of 2.25%, 4.50% and 9.00%, the animals grow well in the experimental period, and the weight, the weight gain, the food utilization rate, the blood conventional index, the blood biochemical index, the visceral weight and the ratio of the visceral weight to the body weight of each dosage group are compared with those of a control group, so that no significant difference exists (P is more than 0.05). Gross anatomy and histopathological examination revealed no obvious sample-related abnormal changes. The capsule of the composition of the invention is prompted to have no obvious toxic and side effect on rats after being fed for 30 days.

Materials and methods

The sample is the composition capsule, the oral administration recommended dose of the human is 5.4g per day, the weight is calculated according to 60kg, and the reduced dose is 0.09 g/kg-bw. The experimental environment of SPF Kunming mouse and SD rat is a barrier environment, the temperature of the experimental environment is 22-24 deg.C and the humidity is 50-56% during the experiment.

(1) Acute toxicity test of mice:

adopting a maximum tolerated dose method, selecting 20 SPF Kunming mice with the weight of 18 g-22 g, and half of the mice. The content of the soft capsule is taken to be orally administered to a mouse for intragastric administration for 1 time, the intragastric administration volume is 0.2ml/10g · bw, the measured specific gravity is 0.936g/ml, and the reduced dose is 18.72g/kg · bw. Fasting was carried out for 16 hours before gavage, and two weeks after gavage were observed continuously, and the toxic manifestation and death were recorded.

(2) Ames test:

the four strains of the salmonella typhimurium histidine-deficient strain TA97, TA98, TA100 and TA102 which are identified to meet the requirements are adopted for the test. Rat liver microsomal enzyme (S-9) induced by polychlorinated biphenyl (PCB) is adopted as an in-vitro metabolism activation system. Five doses were set for the test, 5000. mu.g/dish, 1000. mu.g/dish, 200. mu.g/dish, 40. mu.g/dish, 8. mu.g/dish, together with spontaneous regression, solvent control and positive mutagen control. When the sample is prepared, 1.25g of soft capsule content is taken and added with dimethyl Asia blockhouse to 25ml, the soft capsule content is placed in a water bath at 60 ℃ for 30 minutes and is fully and uniformly mixed, filter membrane suction filtration sterilization is carried out, the dosage is 5000 mu g/vessel, sterile DMSO is added to 25ml to prepare 1000 mu g/vessel by taking 5ml of the soft capsule content in aseptic operation, and the following three dosages are prepared by analogy. During the test, 0.1ml of test strain enrichment liquid, 0.1ml of test substance solution and 0.5ml of S-9 mixed solution (when metabolic activation is needed) are added into top agar, mixed uniformly and poured onto a bottom culture medium plate. The culture was incubated at 37 ℃ for 48 hours, and the number of colonies per dish was counted. If the number of the test object's retrogradation colonies exceeds the number of the spontaneous retrogradation colonies by more than 2 times, and the test object has a dose-response relationship, the test object is determined to be positive. Three parallel dishes were set for each dose and the whole set of experiments was repeated under the same experimental conditions.

(3) Mouse marrow pleochromocyte micronucleus test:

the test was performed by oral gavage twice at intervals of 24 hours. 50 Kunming mice with the weight of 25 g-30 g are randomly divided into 5 groups, each group comprises 10 mice, and the mice are half female and half male. Cyclophosphamide at a dose of 0.04 g/kg-bw was used as a positive control, and vegetable oil was used as a negative control. The high, medium and low doses of the test group are respectively 10.00g/kg · bw, 5.00g/kg · bw and 2.50g/kg · bw, 50.00g, 25.00g and 12.50g of samples are respectively taken and vegetable oil is added to 100ml, and corresponding test solution is prepared to be used for stomach filling (0.20ml/10g · bw) of the mice. Animals were sacrificed by cervical dislocation 6 hours after the last sample administration, and sternal bone marrow was diluted with calf serum and smeared, fixed with methanol, and stained with Giemsa. Under an optical microscope, 1000 pleochromophilic erythrocytes (PCE) were counted per animal, and the micronucleus incidence was measured in PCE per mille containing micronucleus. 200 pleochromophilic erythrocytes were counted, and the ratio of pleochromophilic erythrocytes to mature erythrocytes (PCE/NCE) was calculated. Statistical analysis was performed using Spssll.0 software.

(4) Mouse teratospermia test:

25 male Kunming mice with the weight of 25 g-35 g are randomly divided into 5 groups, and each group comprises 5 mice. Cyclophosphamide at a dose of 0.04 g/kg-bw was used as a positive control, and vegetable oil was used as a negative control. The high, medium and low doses of the test group are respectively 10.00g/kg · bw, 5.00g/kg · bw and 2.50g/kg · bw, samples are respectively taken, 50.00g, 25.00g and 12.50g of vegetable oil are added to 100ml, corresponding test solution is prepared to be used for intragastric administration (0.20ml/10g · bw) to mice, the mice are intragastric administered once a day for 5 days continuously, the animals are killed on the 30 th day after the last intragastric administration, epididymal smears are taken and stained with eosin, 1000 sperms with complete structures are counted in each animal, and the incidence rate of the abnormal sperms is calculated. Statistical analysis was performed using Spssll.0 software.

(5) Feeding test for 30 days:

80 SD rats were selected, half female and half male. Experimental animals were randomly divided into four groups, i.e., a control group and three test subject groups, each group containing 20 animals each with half of males and females. The low, medium and high doses are respectively 2.25g/kg · bw, 4.50g/kg · bw and 9.00g/kg · bw, which respectively correspond to 25, 50 and 100 times of the recommended dose for human body. The sample is mixed into feed for sample feeding, the samples are added into a low dosage group, a medium dosage group and a high dosage group according to the proportion of 2.25 percent, 4.50 percent and 9.00 percent respectively, the protein content of the feed is 22 percent, and the casein is added into the feed of the high dosage group 0.98 percent. The control group was fed basal diet for 30 consecutive days.

During the experiment, all animals are fed in a single cage, freely eat drinking water, the activities and growth conditions of the animals are observed every day, the animals are fed for 2 times every week, the food feeding amount and the food remaining amount are recorded, the weight is weighed once every week, the food feeding amount and the food utilization rate are calculated, and the animals are fed for 30 days and then are fasted for 16 hours for blood taking. Animals were weighed before and after fasting (before blood withdrawal). During blood collection, each rat picks up eyeballs and collects two blood: anticoagulated blood was measured by haemoglobin (Hb) and Hematocrit (HCT) using an yapei CD3700 fully automatic blood cell counter, and Red Blood Cells (RBC), White Blood Cells (WBC), and Platelets (PLT) were counted and WBC was classified. The non-anticoagulated blood serum was separated and TP, ALB, ALT, Cr, BUN, AST, CHOL, TG and GLU were measured by an OLYMPUSAU400 full-automatic biochemical analyzer. The animal is subjected to gross anatomy by dislocation of the cervical vertebra after blood sampling, the weight of the liver, the kidney, the spleen and the testis is weighed, the ratio of the viscera to the body is calculated, and the liver, the kidney, the spleen, the stomach, the duodenum, the testis and the ovary are taken for pathological section examination. When general examination of animals in each dose group shows no obvious lesion and no change of biochemical indexes, histopathological examination of main organs of animals in the highest dose group and the control group is only carried out, and corresponding organs and tissues in the lower dose group are examined if lesions are found.

Statistical analysis was performed using Excel2003, Spssll.0, INSTAT software. During analysis, the data are subjected to homogeneity of variance test, if the variances are uniform, overall comparison is carried out by adopting one-factor analysis of variance, and two-two comparison between the mean values of a plurality of dose groups and a control group is carried out by using a Dunnett method after the differences are found. If the variances are not uniform, proper variable conversion is carried out on the original data, and after the homogeneity of the variances is tested, statistics is carried out by using the converted data; if the purpose of uniform variance is not achieved after variable conversion, statistics is carried out by using a rank and test, and the overall comparison is found to be different, two-by-two comparison is carried out by using a Tamhane' sT2 test which does not require uniform variance.

Secondly, the results

TABLE 10 sample results of acute oral toxicity test mouse body weight: (

g)

Table 11 sample mouse acute toxicity test results

Sex	Animal number (only)	Pathway(s)	Dosage (g/kg bw)	Death number (only)	MTD(g/kg·bw)
						Male part	10	Through the mouth	18.72	0	>18.72
Female part	10	Through the mouth	18.72	0	>18.72

As can be seen from tables 10 and 11, the composition capsule of the present invention at a dose of 18.72g/kg · bw showed no significant toxic symptoms after intragastric administration to Kunming mice of both sexes, and no death was observed for 14 days. At the end of the observation period, the tested animals are sacrificed and subjected to anatomical examination, and no obvious abnormal changes are seen in main organs such as liver, spleen, kidney, stomach, intestine, heart, lung and the like. The Maximum Tolerated Dose (MTD) of the composition capsules of the invention to female and male mice of Kunming species is greater than 18.72g/kg bw. According to the acute toxicity grading standard in the technical Specification for health food inspection and evaluation (2003 edition), the traditional Chinese medicine belongs to the non-toxic grade.

TABLE 12 sample Ames test results (first time)

TABLE 13 sample Ames test results (second)

As can be seen from tables 12 and 13, the number of the colony of each sample dose group after the addition of S-9 was not more than 2 times of the number of the colony of spontaneous regression with respect to the four test strains TA97, TA98, TA100 and TA102, and there was no dose-response relationship.

TABLE 14 Effect of samples on mouse bone marrow micronucleus incidence

P <0.01 in comparison with negative control group

As can be seen from Table 14, the micronucleus rates of the samples of the respective dose groups were not significantly different from those of the negative control group (P >0.05), while those of the cyclophosphamide group were significantly different from those of the negative control group (P < 0.01).

TABLE 15 Effect of samples on mouse incidence of teratospermia

P <0.01 in comparison with negative control group

As can be seen from Table 15, the rate of teratospermia of mice in each dose group was not significant (P >0.05) compared with the negative control group, while the rate of teratospermia of mice in the cyclophosphamide positive control group was significant (P <0.01) compared with the negative control group.

Feeding test for 30 days: during the feeding period of 30 days, the animals in each group grow well without abnormal behaviors and toxic symptoms and death.

The effect of the samples on the conventional indices of the rat blood is shown in tables 16-18. The hemoglobin, total number of red blood cells, hematocrit, platelet number, total number of white blood cells and classification of the male and female rats in each dose group are compared with those in the control group, and the difference is not significant (P > 0.05).

TABLE 16 results of hematological examination of samples fed for 30 days

TABLE 17 Effect of samples on rat WBC count and Classification thereof

TABLE 18 Effect of samples on rat WBC count and Classification thereof

Effect of samples on biochemical indices of rats: see tables 19-20. Total protein, albumin, glutamic-pyruvic transaminase, glutamic-oxalacetic transaminase, cholesterol, triglyceride, urea nitrogen, creatinine and blood sugar of male and female rats in each dose group have no significant difference compared with those in a control group (P > 0.05).

TABLE 19 end-stage Biochemical test results of 30-day feeding test for samples

TABLE 20 end-stage Biochemical test results for 30-day feeding test of samples

Effect of samples on body weight, organ weight and organ/body ratio after rat experiment without fasting: as can be seen from tables 21-22, the weight and absolute liver, kidney, spleen, testis, and liver/body, plate/body, kidney/body, and male mouse testis/body ratios of the rats in each dose group after fasting were not significant (P > 0.05).

TABLE 21 Effect of samples on weight and organ weight after non-fasting rats

TABLE 22 Effect of samples on rat visceral volume ratio

General anatomical examination: the control group and each dose group were examined for 80 rats, female and male halves. After the autopsy, no obvious abnormality is seen in the color, size, morphological structure and the like of the main organs such as heart, lung, liver, spleen, kidney, stomach, intestine, testis (ovary) and the like.

And (3) microscopic examination: the rats in the high dose group and the control group were examined 20 rats each, and the rats in the female and male half.

Liver: the capsule is intact and the lobular structure of the liver is clear. Wherein 1 hepatocyte of the female mouse of the control group has punctate necrosis, and 1 hepatocyte of the female mouse of the high-dose group has a small amount of inflammatory cell infiltration.

Kidney: the capsule is intact, and the glomerulus and renal tubule are normal in structure. Wherein, 1 female mouse in the control group and 1 male mouse in the high-dose group have a small amount of inflammatory cell infiltration in renal interstitium.

Gastrointestinal tract: the structure of each layer is clear, the upper layer of the mucosa is complete, and the lower layer of the mucosa is not abnormal.

Spleen: the capsule is intact, the spleen trabecular structure is normal, the proportion of red and white marrow is normal, and no abnormality is found.

Ovary: the epithelium and the leucoderma are normal, and all levels of follicles develop well without abnormality.

Testis: the spermatogenic cells at all levels in the seminiferous tubules develop well, and the stroma is not abnormal.

The examination results show that no obvious histopathological changes related to the experimental factors are found in the liver, spleen, kidney, stomach, intestine and testis (ovary) of the female rat and the male rat in the high-dose group.

And (3) knotting: under the laboratory condition, the Maximum Tolerated Dose (MTD) of the composition capsule of the invention to female and male Kunming mice is more than 18.72g/kg bw, and the composition capsule belongs to non-toxic grade. The Ames test, mouse marrow pleochromocyte micronucleus test and mouse sperm malformation test result are all negative. The samples are added into the feed for feeding rats for 30 days according to the proportion of 2.25%, 4.50% and 9.00%, the animals grow well in the experimental period, and the weight, the weight gain, the food utilization rate, the blood conventional index, the blood biochemical index, the visceral weight and the ratio of the visceral weight to the body weight of each dosage group are compared with those of a control group, so that no significant difference exists (P is more than 0.05). Gross anatomy and histopathological examination revealed no obvious sample-related abnormal changes. The composition capsule of the invention is prompted to have no obvious toxic and side effect on rats after being fed for 30 days.

Claims

1. A composition for reducing blood fat and improving memory is characterized in that: the composition mainly comprises, by weight, 340 parts of walnut oil, 55-65 parts of soybean phospholipid, 20-24 parts of ginkgo leaf extract, 5.6-6.6 parts of natural vitamin E, 180 parts of soybean oil, 16-18 parts of beeswax, 540 parts of gelatin 500-.

2. The composition for reducing blood lipid and improving memory according to claim 1, wherein: the components comprise, by weight, 320 parts of walnut oil, 60 parts of soybean phospholipid, 22 parts of ginkgo biloba extract, 6 parts of natural vitamin E, 175 parts of soybean oil, 17 parts of beeswax, 520 parts of gelatin, 220 parts of glycerol, 480 parts of purified water, 1.8 parts of titanium dioxide and 0.8 part of cocoa shell pigment.

3. A method for preparing the composition for reducing blood lipid and improving memory according to claim 1 or 2, wherein the method comprises the following steps:

4. The preparation method of the composition for reducing blood lipid and improving memory according to claim 3, wherein the composition comprises the following components: the extraction method of the walnut oil comprises the steps of removing shells of walnut fruits with intact quality to obtain walnut kernels, cleaning the walnut kernels, drying, crushing into coarse particles with the diameter of 0.2-0.6 cm, directly cold-pressing by adopting a cold-pressing type oil press at the pressure of 28-38MPa to obtain the walnut oil, standing the walnut oil for 18-24 hours, taking supernate, centrifuging at the rotating speed of 2600 plus materials per minute and 3200 revolutions by using a high-speed centrifuge, taking supernate, filtering by using a filter screen with 80-200 meshes, discarding filter residues, filling filtrate to obtain a walnut oil finished product.

5. The preparation method of the composition for reducing blood lipid and improving memory according to claim 3, wherein the composition comprises the following components: the extraction method of the soybean phospholipid comprises the steps of selecting mature, full and uniform high-quality soybeans, cleaning the soybeans with clear water, putting the soybeans into an oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into fine powder by using an ultrafine crusher, adding a 10% cellulase solution with the weight ratio of the soybean powder being 2.0-4.0%, adding water with the volume being 1 time of the soybean powder, stirring the mixture uniformly, keeping the temperature for 1-2 hours at the temperature of 45-60 ℃, adding water with the volume being 2.5-3.5 times of the soybean powder into the solution, stirring the mixture uniformly, filtering the mixture by using a 40-70 mesh screen, removing large-particle impurities, adding the remained solution into a nanofiltration membrane, performing nanofiltration under the pressure of 0.75-0.95MPa, collecting filtrate, and performing reduced pressure concentration at the temperature of 65-78 ℃ to obtain a soybean phospholipid finished product.

6. The preparation method of the composition for reducing blood lipid and improving memory according to claim 3, wherein the composition comprises the following components: the preparation method of the ginkgo leaf extract comprises the steps of selecting clean and impurity-free ginkgo leaves, adding 70% ethanol in an amount which is 2.5-3.5 times of the amount of the ginkgo leaves, carrying out reflux extraction for 1-2 hours, filtering, combining filtrate, recovering ethanol, adding water in an amount which is 1.3-1.8 times of the amount of the ginkgo leaves, uniformly stirring, centrifuging, filtering supernate, enabling the filtrate to pass through a macroporous adsorption resin column, keeping the filtrate higher than resin, keeping for 2-4 hours, washing with 2.5-3.5 times of the amount of the ginkgo leaves, eluting with 65-75% ethanol in an amount which is 3.5-4.5 times of the amount of the ginkgo leaves, collecting 65-75% ethanol eluent, recovering ethanol, concentrating to extract liquid with the relative density of 1.06-1.14, carrying out spray drying to obtain dry extract powder, crushing and sieving to obtain the ginkgo leaf extract.

7. The preparation method of the composition for reducing blood lipid and improving memory according to claim 3, wherein the composition comprises the following components: the preparation method of the natural vitamin E comprises the steps of selecting mature, full and uniform-size high-quality soybeans, cleaning the soybeans with clear water, putting the soybeans into a drying oven, drying the soybeans at the temperature of 50-70 ℃, crushing the soybeans into coarse powder passing through a 40-80-mesh screen, directly cold pressing the coarse powder by using a cold pressing type oil press under the pressure of 32-50MPa, pressing the coarse powder to remove oil, discarding the oil, adding 1.3-1.8 times of water into the solid materials after oil removal, uniformly stirring and mixing the mixture, putting the mixture into a wiped film evaporator, evaporating the mixture under the vacuum degree of-0.06-0.08 MPa to remove water and volatile substances in the solid materials, adding 2 times of ethanol into the treated oily materials, uniformly stirring and mixing the mixture, taking potassium sorbate with the weight of 0.035-0.045% of the oily materials and liquid maltitol with the weight of 0.045-0.065% of the oily materials as materials A, taking 54-68% ethanol water solution 5-8 times of the total weight of the material A as a material B, slowly adding the material B into the material A under the condition of continuous stirring, then fully stirring to uniformly mix the material A and the material B, taking the material C as a material C, slowly adding the material C into the oily matter under the condition of continuous stirring, stirring at room temperature for 15-25 minutes to fully mix the material C, standing for 20-28 hours, filtering through a 60-100 mesh screen, adding 0.8-1.2 times of ethanol into the filter residue to dissolve the filter residue, then adding 0.08-0.12 times of 8-12% acetic acid water solution into the filter residue, stirring and uniformly mixing, heating to 45-55 ℃, keeping the temperature and stirring for 1.5-2.5 hours, standing for 20-28 hours, filtering through a 80-160 mesh screen, evaporating and concentrating the filtrate under the condition of vacuum degree of-0.04 to-0.08 Mpa to obtain the natural vitamin E product.