CN115192628A

CN115192628A - Composition and preparation with memory enhancing effect and preparation method thereof

Info

Publication number: CN115192628A
Application number: CN202211021142.7A
Authority: CN
Inventors: 付文斌; 王庆; 李春艳
Original assignee: Liaoning Huakang Xingchen Pharmaceutical Technology Co ltd
Current assignee: Liaoning Huakang Xingchen Pharmaceutical Technology Co ltd
Priority date: 2022-08-24
Filing date: 2022-08-24
Publication date: 2022-10-18

Abstract

The invention belongs to the technical field of pharmaceutical compositions, and relates to a composition with a memory-enhancing effect, a preparation and a preparation method thereof, wherein the composition with the memory-enhancing effect comprises the following raw materials in parts by weight: 115 to 190 parts of DHA algae oil, 100 to 150 parts of lecithin, 15 to 55 parts of taurine, 145 to 220 parts of walnut oil and 5 to 15 parts of beeswax. The invention aims to disclose a composition with a memory enhancing function, a preparation and a preparation method thereof, which can improve the energy supply of cells, promote the nutrient absorption of brain cells, repair damaged brain cells, improve the activity of the brain cells, greatly enhance the memory and are healthy and safe.

Description

Composition and preparation with memory enhancing effect and preparation method thereof

Technical Field

The invention belongs to the technical field of pharmaceutical compositions, and relates to a composition with a memory enhancing effect, a preparation and a preparation method thereof.

Background

The memory is the ability to remember, maintain, reconsider and reproduce the content and experience reflected by objective things, the memory is the basis of all intellectual activities, all knowledge is obtained as memory, the memory is a bridge for developing from perceptual knowledge to rational knowledge, the memory of one person is poor, and the learning and the life of the person are limited; with good memory, people can well store past reflection, can link up the prior experience, continuously accumulate, enlarge, perfect or correct the past reflection, and have more guiding value for the existing action.

During learning, the learning memory of a person begins to decline, and through research and analysis, the causes of decline of the memory are roughly divided into: (1) Other diseases caused by diseases, such as cerebrovascular diseases, immune encephalitis, diseases of the mental system and the like, for example, cerebral infarction, can cause serious memory loss, and patients can also have dizziness, nausea, blurred vision, limb numbness and weakness with abnormal behaviors, dysfunction and the like; furthermore, mental diseases such as schizophrenia can also cause memory impairment, and many common diseases affect memory clinically; (2) With the continuous increase of age, the memory of human body is gradually reduced, which belongs to physiological change, mainly caused by the slow metabolism of human cells, the supply of oxygen and blood to the brain by cell circulation, the slow speed of energy supply and the reduction of the activity of brain cells; (3) Environmental factors and psychological factors, if the brain is in a nervous learning atmosphere for a long time, when the brain is under high pressure and is under excessive anxiety and tension, the brain is always in a fatigue state, and memory decline also occurs.

At the present stage, a plurality of methods are provided for the problem of decline of learning memory, and the memory is memorized through hearing, so that the integration of labor and ease is ensured, sufficient sleep is kept, and the mind is ensured to be clear; some foods effective in enhancing memory of human body are often eaten, aerobic exercises are often done, and in addition, memory is improved by means of medicines, but the methods have the following problems: the traditional Chinese medicine composition is not used for treating symptoms and root causes, the degree of improving the memory is limited, and the medicine for improving the memory possibly contains antidepressant and tranquilizer components and is easy to generate dependence after long-term administration, so that the research on a healthy, green and safe way and a method capable of improving the memory fundamentally is the objective of attention of researchers.

Disclosure of Invention

The invention aims to disclose a composition with a memory enhancing function, a preparation and a preparation method thereof, which can improve the energy supply of cells, promote the nutrient absorption of brain cells, repair damaged brain cells, improve the activity of the brain cells, greatly enhance the memory and are healthy and safe.

In order to achieve the purpose, the invention adopts the technical scheme that:

a composition with a memory enhancing effect comprises the following raw materials in parts by weight: 115 to 190 parts of DHA algae oil, 100 to 150 parts of lecithin, 15 to 55 parts of taurine, 145 to 220 parts of walnut oil and 5 to 15 parts of beeswax.

Further, the composition with the function of enhancing memory comprises the following raw materials in parts by weight: 130 to 165 parts of DHA algae oil, 110 to 140 parts of lecithin, 20 to 40 parts of taurine, 160 to 200 parts of walnut oil and 8 to 12 parts of beeswax.

Further, the composition with the function of enhancing memory comprises the following raw materials in parts by weight: 150 parts of DHA algal oil, 120 parts of lecithin, 30 parts of taurine, 190 parts of walnut oil and 10 parts of beeswax.

A preparation with memory enhancing effect comprises the composition with memory enhancing effect and capsule shell material; the weight ratio of the composition with the memory enhancing effect to the capsule shell material is 5:4.

further, the weight ratio of the leather materials of the bag is 5:5:2, gelatin and glycerin.

The preparation method of the preparation with the function of enhancing memory comprises the following steps:

1) Preparing the following raw materials in parts by weight: DHA algae oil, walnut oil, beeswax, lecithin, purified water, gelatin and glycerol;

2) Mixing and melting DHA algae oil, walnut oil, beeswax and lecithin at 70 +/-0.5 ℃, then cooling to 45 +/-0.5 ℃, mixing with taurine for 25-30 min, stirring uniformly, grinding for 2 times by using a colloid, sieving by using a 100-mesh sieve, standing, vacuumizing, discharging bubbles, and degassing in vacuum to obtain capsule core feed liquid;

3) Uniformly stirring purified water and glycerol, heating to 70 +/-0.5 ℃, adding gelatin, heating to 70-72 ℃, sealing and stirring until uniform glue solution is formed, vacuum degassing, pressurizing to obtain glue, sieving with a 100-mesh sieve, and keeping the obtained glue solution at 60 ℃ to serve as a capsule shell material for later use;

4) And (4) pelleting the capsule core material and the capsule shell material by a pelleting device, and sequentially carrying out shaping, washing and drying to obtain the preparation.

Furthermore, in the step 2) and the step 3), the vacuum degree of vacuum degassing is-0.05-0.08 MPa.

Further, in the step 4), the pelleting conditions are as follows: the temperature is 18-26 ℃, and the relative humidity is 30-40%; the setting conditions are that the temperature is 18-26 ℃ and the relative humidity is 30-40%; the pill washing adopts 95% alcohol; the drying conditions are as follows: the time is 10 to 25 hours, the temperature is 24 to 28 ℃, and the relative humidity is 18 to 30 percent.

The invention has the beneficial effects that:

1. the composition with the memory enhancing function provided by the invention comprises DHA algae oil, lecithin, taurine, walnut oil and beeswax, wherein the DHA algae oil can supplement nutrient substances of cranial nerve cells, and the lecithin can accelerate information transfer while providing nutrition for the cranial nerve cells; taurine increases transmitter content, and can be used as brain metabolism reactivator; the walnut oil can improve the metabolism function of cells and resist MAO oxidation of brain tissues; the beewax is beneficial to the growth and development of an organism and can improve the disease resistance of the organism, the five substances act together to realize synergistic interaction, the metabolism can be fundamentally accelerated, the cell circulation is improved to supply oxygen and blood to the brain, energy is provided, the activation and development of the brain cells are effectively promoted, the damaged brain cells are repaired, the activity of the brain cells is improved, the memory is greatly enhanced, and the raw materials are food-grade, safe, free of side effects and free of dependence; the composition of the invention supplements brain nutrients, resists brain tissue oxidation, assists in improving memory and thereby improves learning and memory.

2. The invention provides a capsule preparation prepared by adding purified water, gelatin and glycerol on the basis of the composition with the function of enhancing memory, which is convenient to use, prolongs the storage time and has good stability. Meanwhile, the invention discloses a preparation method of the preparation, and large-scale production is realized.

Detailed Description

The composition with the memory enhancing function provided by the invention comprises DHA algae oil, lecithin, taurine, walnut oil and beeswax.

DHA algal oil: it contains rich DHA, is an important part of brain, and is also an essential substance for normal nerve function. DHA is mainly present in the components of Phosphatidylethanolamine (PE) and Phosphatidylserine (PS), while PE is in turn the main phospholipid component of the nerve cell membrane.

Lecithin: the phospholipid mixture is composed of phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidylserine and other components, wherein the first three components are most typical, and the phospholipid is an important component of cell membranes and brain nerve cells, can effectively improve brain functions, enhance information transfer among brain neurons, accelerate memory and maintain high level of thinking ability and intelligence quotient.

Taurine, which is selectively distributed in the brain, cerebellum and hippocampus, is an important excitatory neurotransmitter next to glutamate in the brain.

The walnut oil is mainly linoleic acid and alpha-linolenic acid, and the abundant linoleic acid and linolenic acid can remove impurities metabolized in blood vessels, purify blood and provide fresh blood for brains. The walnut oil can increase the content of serum T-SOD and reduce the effects of serum MDA and brain tissue MAO. The walnut oil has the effects of strengthening and nourishing brain, and can effectively prevent the occurrence of senile dementia.

Beeswax: wax secreted by Apiceranea Fabricius or Apismellifera Linnaeus, an insect of the family Apidae; the beeswax and the emulsion thereof have the functions of bacteriostasis and corrosion prevention; the beeswax also has the characteristics of good plasticity, good release property, filming, water resistance, moisture resistance, oxidation and deterioration resistance and the like. The main chemical components comprise: esters (70% -72%) formed from alkanol and alkanoic acid, free fatty acid (14% -15%) and hydrocarbon (12%) using saturated hydrocarbon as main component, also includes partial free fatty alcohol, water and mineral substance and small quantity of flavone, vitamin and pigment, etc.

Furthermore, on the basis of the composition with the memory enhancing effect, purified water, gelatin and glycerol are added to obtain a preparation with the memory enhancing effect, and the preparation is in a capsule shape, is convenient to use, prolongs the storage time and has good stability. Meanwhile, the preparation method disclosed by the invention realizes large-scale production and promotes digestion and absorption of the composition.

Gelatin: the hydrolysate of collagen is a high protein without fat, does not contain cholesterol, and is a natural nutritional food thickener; after being eaten, people can not become fat, and the physical strength can not be reduced; gelatin is also a strong protective colloid, has strong emulsifying power, and can inhibit coagulation of proteins such as milk and soybean milk due to gastric acid after entering stomach, thereby facilitating digestion of food.

Glycerol: the edible glycerin is a biological refined glycerin, contains reducing sugar such as esters and glucose besides glycerol, belongs to polyol glycerin, and has the special effects of moisture retention, high activity, oxidation resistance, alcoholization promotion and the like. The glycerin is a sweetening agent and a humectant which are commonly used in the food processing industry, can rapidly decompose bitter and astringent peculiar smell in fruit juice and fruit vinegar beverage, improves the thick taste and the fragrance of the fruit juice, and has bright appearance and palatable sour and sweet taste; in the using process, the glycerol can not change the blood sugar level and the insulin level after being absorbed by a human body.

The invention provides a composition with a memory enhancing effect, which comprises the following raw materials in parts by weight: 115 to 190 parts of DHA algae oil, 100 to 150 parts of lecithin, 15 to 55 parts of taurine, 145 to 220 parts of walnut oil and 5 to 15 parts of beeswax.

Preferably, the composition with the memory enhancing effect consists of the following raw materials in parts by weight: 130 to 165 parts of DHA algae oil, 110 to 140 parts of lecithin, 20 to 40 parts of taurine, 160 to 200 parts of walnut oil and 8 to 12 parts of beeswax.

More preferably, the composition with the function of enhancing memory comprises the following raw materials in parts by weight: 150 parts of DHA algal oil, 120 parts of lecithin, 30 parts of taurine, 190 parts of walnut oil and 10 parts of beeswax.

A preparation with memory improving effect comprises composition with memory improving effect and capsule shell material; the weight ratio of the composition with the memory enhancing effect to the capsule shell material is 5:4. the capsule shell material of the invention comprises the following components in percentage by weight: 5:2, gelatin and glycerin.

The preparation method of the preparation with the function of enhancing memory provided by the invention comprises the following steps:

1) Preparing raw materials in parts by weight: DHA algae oil, walnut oil, beeswax, lecithin, purified water, gelatin and glycerol;

2) Mixing and melting DHA algae oil, walnut oil, beeswax and lecithin at 70 +/-0.5 ℃, then cooling to 45 +/-0.5 ℃, mixing with taurine for 25-30 min, stirring uniformly, grinding for 2 times by using colloid, sieving by using a 100-mesh sieve, standing, vacuumizing, discharging bubbles, and degassing in vacuum to obtain a capsule core feed liquid;

4) And (3) pelleting the capsule core material and the capsule shell material by a pelleting device, and sequentially carrying out sizing, pill washing and drying to obtain the preparation.

In the step 2) and the step 3), the vacuum degree of vacuum degassing is-0.05-0.08 MPa.

In the step 4), the pelleting conditions are as follows: the temperature is 18-26 ℃, and the relative humidity is 30-40%; the setting conditions are that the temperature is 18-26 ℃ and the relative humidity is 30-40%; the pill washing adopts 95% alcohol; the drying conditions were: the time is 10 to 25 hours, the temperature is 24 to 28 ℃, and the relative humidity is 18 to 30 percent.

The preparation with the memory enhancing function provided by the invention has a synergistic interaction effect, accelerates metabolism, supplements brain nutrients, resists brain tissue oxidation, improves cell circulation to supply oxygen and blood to the brain, provides energy, effectively promotes activation and development of brain cells, repairs damaged brain cells, enhances activity of the brain cells, assists in improving memory, improves learning memory and assists in improving learning memory.

The present invention will be described in detail with reference to specific examples.

Examples 1 to 7

The compositions with memory enhancing effect provided in examples 1 to 7 all consist of DHA algal oil, lecithin, taurine, walnut oil and beeswax, and the weight parts are shown in table 1.

DHA content in the DHA algae oil raw material is more than or equal to 35%; in the lecithin raw material, the content of phosphatidylcholine is more than or equal to 45 percent; the taurine raw material contains 98.8-101.5% of taurine, 50-69% of linoleic acid and 6.5-18% of linolenic acid.

TABLE 1 weight ratio of compositions with memory enhancing effect provided in examples 1-7

	Example 1	Example 2	Example 3	Example 4	Example 5	Example 6	Example 7
								DHA algae oil	115	125	130	150	160	175	190
Lecithin	150	145	140	120	110	105	100
								Taurine	15	18	20	30	40	50	55
Walnut oil	220	210	200	190	160	152	145
								Beeswax (Cera flava)	5	7	8	10	12	14	15

The content of the main functional components in the composition with the effect of enhancing memory is determined by the existing detection method, and the content is shown in table 2.

TABLE 2 content of effective component in each composition

Referring to table 2, the content of taurine in the compositions provided in examples 1 to 7 increases with the amount of the taurine, while the content of several functional components including DHA, phosphatidylcholine, linoleic acid and linolenic acid increases and decreases, and the content is the highest when the formulation of example 4 is used, which indicates that example 4 is the preferable amount ratio of the present invention.

Example 8

The embodiment provides a preparation with memory enhancing effect, which consists of a composition with memory enhancing effect and a capsule shell material; the composition with the memory enhancing effect adopts the mixture ratio of the embodiment 4 by weight, namely: 150 parts of DHA algae oil, 120 parts of lecithin, 30 parts of taurine, 190 parts of walnut oil and 10 parts of beeswax, wherein the weight ratio of the composition with the memory enhancing effect to the capsule shell material is 5:4.

in the embodiment, the weight ratio of the bladder shell material is 5:5:2, gelatin and glycerin.

This example provides a method for preparing a formulation with memory enhancing effect, comprising the steps of:

1) Preparing raw materials in parts by weight: DHA algal oil, walnut oil, beeswax, lecithin, purified water, gelatin and glycerin.

2) Under the heating condition, uniformly stirring DHA algae oil, walnut oil, beeswax and lecithin, adding taurine, uniformly stirring, grinding by a colloid mill, and degassing in vacuum to obtain a capsule core material for later use.

Heating DHA algae oil, walnut oil, soybean phospholipid and beeswax to 70 ℃ to melt the DHA algae oil, the walnut oil, the soybean phospholipid and the beeswax, then cooling to 45 ℃ to mix with taurine for 30 minutes, stirring uniformly, passing through a colloid mill for 2 times, sieving through a 100-mesh sieve, standing, vacuumizing, discharging bubbles, and degassing in vacuum (the vacuum degree is-0.05-0.08 Mpa), thus obtaining the capsule core feed liquid.

3) Heating purified water, adding gelatin and glycerol, stirring, vacuum degassing, filtering, and keeping at 60 deg.C to obtain capsule shell material.

Adding purified water and glycerol into a vacuum stirring tank in sequence, heating, adding gelatin, covering and sealing, starting a stirring paddle for stirring, continuously heating to 70-72 ℃, keeping the temperature and stirring to obtain uniform glue solution, stopping stirring, standing, vacuumizing and degassing, discharging bubbles in the glue solution, pressurizing to discharge the glue solution, sieving by a 100-mesh sieve, injecting the glue solution into a heat-preservation barrel, keeping the temperature (60 ℃) for placing, and carrying out visual inspection to ensure that no bubbles and impurities exist.

Specifically, pelleting: the prepared capsule core feed liquid is conveyed to a storage tank of the soft capsule machine, and the prepared capsule shell glue liquid is conveyed to a liquid storage tank of the soft capsule machine for heat preservation (60 ℃). After the capsule core material liquid and the capsule shell glue liquid are prepared, a soft capsule machine is started to press the capsules, the thickness of the capsule shell and the weight of the content of each capsule are controlled to be 0.5g, the temperature is 18-26 ℃, and the relative humidity is 30-40%. In a clean zone of 10 ten thousand levels.

Shaping: the pressed capsule is conveyed into a rolling cage, the capsule rolls along with the rolling cage for 3 to 4 hours, the capsule is cooled, the moisture on the surface of the capsule is removed, the capsule is shaped, the temperature between operations is 18 to 26 ℃, and the relative humidity is 30 to 40 percent. In a clean zone of 10 ten thousand levels.

Washing pills: cleaning the shaped capsule with 95% ethanol, and volatilizing ethanol.

And (3) drying: placing the soft capsules into a drying tray, and placing the soft capsules into a drying chamber for drying for 10 to 25 hours, wherein the temperature of the drying chamber is between 24 and 28 ℃, and the relative humidity is between 18 and 30 percent. 10 ten thousand grades of clean zone.

And (4) checking pills after drying, specifically putting the dried soft capsules on a lamp inspection machine, manually selecting unqualified pills such as irregular pills, shrunken pills, thin-wall pills and pills with inconsistent sizes, and packaging the qualified soft capsules.

To illustrate the memory enhancing assistance of the memory enhancing formulation provided in this example, the following test was performed.

Test 1

1. Sample preparation: the preparation prepared in example 8 is used as a test sample of the experiment, and the sample property is yellow oily paste; sealing the sample, and storing the sample in a cool and dry place; the recommended human dose for the test sample is 2.0 g/person/day.

2. Experimental animals: 240 SPF-grade CI/F1-generation healthy male mice were selected.

The first experimental animal is 120 mice, the initial weight range of each parallel experimental group is 19.0-21.9 g, the mice are randomly divided into three large groups of I, II and III according to the weight, each large group is 40 mice, and the mice are divided into 4 dosage groups, and each dosage group is 10 mice. The group I is subjected to a mouse jump test, the group II is subjected to a mouse dark avoidance test, and the group III is subjected to a mouse water maze test.

The initial weight range of each parallel experimental group is 19.0-21.9 g, the mice are randomly divided into three large groups I, II and III according to the weight, each large group comprises 40 mice, each large group comprises 4 dosage groups, and each dosage group comprises 10 mice. The group I is subjected to a mouse jump test, the group II is subjected to a mouse dark avoidance test, and the group III is subjected to a mouse water maze test.

The test animals are raised in a barrier environment with the temperature of 20-25 ℃ and the relative humidity of 40-70%.

3. Dosage selection and subject administration

The recommended human dose of the test sample is 2.0 g/human/day (based on 60kg body weight), three dose groups of 0.17 g/kg-bw/d and 0.33 g/kg-bw/d are respectively 1.00 g/kg-bw/d (corresponding to 5 times, 10 times and 30 times of the recommended human intake of the test sample respectively), and corn oil is used for replacing the test sample in the 0 g/kg-bw/d group.

The tested sample is prepared by corn oil sterile water, the preparation concentration of low, medium and high dose is respectively 17mg/mL,33mg/mL and 100mg/mL, the tested sample with corresponding dose is orally administered to a mouse once a day, and the intragastric administration amount of the mouse is 0.1mL/10g & bw. After 1 month continuously, various indexes for improving memory function are measured.

4. Test method

The method is carried out according to the auxiliary memory function test method in the technical Specification for health food test and evaluation (2003 edition).

(1) Diving tower test

Each dose group animal was gavaged continuously for 1 month. The next day after the last sample feeding, the mouse is placed in a reaction box to adapt for 3min, then the mouse is placed on a copper grid in the reaction box, 36v of alternating current is immediately conducted, the mouse is shocked, and the mouse jumps back to the platform. After training once, the mice are placed on a platform in a reaction box, and the time (namely the latency) for each mouse to jump off the platform for the first time and the error times for jumping off the platform within 5min are recorded. And (5) retesting for 24h, placing the mice on the platform, recording the latency period of the first time each mouse jumps off the platform, the number of times of electric shock in 3min of each mouse and the total number of the electric shock mice, and calculating the percentage of the mice with error reaction. And after stopping training for 5d, repeating the test once according to the retest method.

If the test sample group is compared with the control group, the incubation period is obviously prolonged, the number of errors or the number of animals jumping down the platform is obviously less than that of the control group, the difference is significant, and the test can be judged to be positive if any index of the three indexes is positive.

(2) Dark avoidance test

Each dose group animal was gavaged continuously for 1 month. The next day after the last sample administration training was started. The mouse face back to the opening is placed in the bright room and the timer is started. The mouse passes through the hole and enters the darkroom to be shocked, the timer is stopped, the mouse is taken out, the shocked time (namely the latency) from the time when each mouse is placed in the brightroom to the time when the mouse enters the darkroom for the first time is recorded, and the shocked time within 5min is recorded. The test was repeated for 24h and the latency, number of shocks received within 5min and percentage of mice entering the dark room within 5min were recorded for each mouse. And after stopping training for 5d, repeating the test once according to the retest method.

If the latency period of the mice of the test sample group entering the dark room is obviously longer than that of the control group, the number of errors entering the dark room within 5min or the number of animals entering the dark room within 5min is less than that of the control group, the difference is significant, and the test can be judged to be positive if any one of the three indexes is positive.

(3) Water maze test

Each dose group animal was gavaged continuously for 1 month. The next day after the last sample administration training was started. The water depth of the maze lane is 9cm, and the water temperature is 20 ℃. The mouse training time was limited to 120s. Before each training, the mouse was placed near the ladder, back on the stairs, and allowed to climb up automatically 1 time. The test is started from A, and the time from A to the end point and the number of errors are recorded. The second test training was started 3 times from B, and the time from B to the end and the number of errors were recorded 3 times. The last time was from the starting point, the mice were placed back to the end point at the starting point, and the time from the starting point to the end point and the number of errors occurred were recorded. Repeat tests were performed from the starting point after 5 days of training cessation.

Compared with the control group, the time taken for the test group to reach the end point or the error frequency before the end point is reached is obviously less than that of the control group, or the number of animals reaching the end point within 2min is obviously more than that of the control group, and the difference is significant through statistical test. The positive result of any index can be judged.

The above three tests were repeated once with another batch of mice. The method is the same as (1), (2) and (3). The test conditions were: the test environment is a special behavior laboratory with sound insulation and light resistance, the temperature of the laboratory is 20-25 ℃, and the relative humidity is 40-70%.

5. Test results

(1) The effect of the samples on body weight in the first and second trials in three groups I, II, III of mice is shown in tables 3-5.

TABLE 3 Effect of samples on body weight in group I mice

TABLE 4 Effect of samples on body weight in group II mice

TABLE 5 Effect of samples on body weight in group III mice

As can be seen from the results shown in tables 3 to 5, the initial body weights, low dose group, medium dose group and high dose group of the first and second test animals were statistically insignificant (p > 0.05) compared with the control group. I.e. the initial body weights of the test animals were more balanced between the groups.

The method comprises the steps of orally administering different doses of test samples to a mouse for 1 month, carrying out the homogeneity test of variance on the body weight increasing value of each dose group in the first test and the second test to meet the requirement of homogeneity of variance, and carrying out statistical treatment by using a pairwise comparison method of mean values between a plurality of experimental groups and a control group in a single-factor variance analysis method. Compared with the control group, the low-dose group, the medium-dose group and the high-dose group have no statistical significance (P > 0.05), and the weight of the mice is not influenced by the samples.

(2) The results of the jump test in the first and second tests are shown in tables 6 to 9.

TABLE 6 sample vs. SmallEffect of mouse diving platform test training test (

N＝10)

Table 7 effect of samples on mouse jump bench test 24h retest (

N＝10)

TABLE 8 Effect of samples on mouse retesting after 5 days of bench test: (

N＝10)

Table 9 comparison of number of animals jumping off the platform in the mouse diving platform test (N = 10)

Different doses of samples were given orally to mice for 1 month, and in the first experiment, the incubation period during training of mice did not meet the requirement of homogeneity of variance, and statistical treatment was performed by the rank sum test. And other indexes meet the requirement of homogeneity of variance, and statistical treatment is carried out by using a one-factor variance analysis method. And (5) counting the number of animals jumping off the platform in the case of retesting after 24h and 5d by using an exact probability method. As can be seen from tables 6-9, the low, medium and high dose groups had no statistical difference in latency, number of errors and number of animals in the jumping platform in each period compared with the control group (P > 0.05).

In the second repeated test, the mice do not meet the requirement of homogeneity of variance in the latency period in 24h retest and the latency period and error frequency in 5d retest, and are subjected to statistical treatment by the rank sum test. And other indexes meet the requirement of homogeneity of variance, and statistical treatment is carried out by using a one-factor variance analysis method. And (5) counting the number of animals jumping off the platform in the case of retesting after 24h and 5d by using an exact probability method. As can be seen from tables 6-9, the latency of the high dose groups after 24h and 5d was longer than that of the control group, and the number of errors of the high dose groups after 5d was less than that of the control group, and the difference was statistically significant (P < 0.05). The number of animals jumping off the platform in the low dose group, the medium dose group and the high dose group after 24h and 5d are compared with the control group, and the difference is not statistically significant (P is more than 0.05).

(3) The results of the dark avoidance test in the first and second tests are shown in tables 10-13.

TABLE 10 Effect of samples on mouse avoidance test training test(s) ((

N＝10)

TABLE 11 Effect of samples on mouse avoidance test 24h retest (

N＝10)

TABLE 12 Effect of samples on mouse Dedarkening test 5d later remeasurement: (

N＝10)

Table 13 comparison of the number of animals entering the dark box in the mouse avoidance test (N = 10)

Different doses of samples are orally given to the mice for 1 month, in the first test, the incubation period of the mice in 24h and 5d post-retesting and the error times in 5d post-retesting do not meet the requirement of homogeneity of variance, and statistical treatment is carried out by using a rank sum test. And other indexes meet the requirement of homogeneity of variance, and statistical treatment is carried out by using a one-factor variance analysis method. The number of animals entering the dark box at 24h and 5d later re-test was statistically processed by an exact probability method. As can be seen from tables 10-13, the latency of the mice in the high dose group after 24h retest was longer than that in the control group, the number of errors was smaller than that in the control group, the difference was statistically significant (P < 0.05), and the number of animals in the high dose group after 24h retest entered the dark box was smaller than that in the control group, and the difference was statistically significant (P < 0.05).

In the second repeated test, the error times of the mice in 24h retesting and the latent period and error times in 5d retesting do not meet the requirement of homogeneity of variance, and statistical treatment is carried out by using the rank sum test. And other indexes meet the requirement of homogeneity of variance, and statistical treatment is carried out by using a one-factor variance analysis method. The number of animals entering the dark box at 24h and 5d later re-test was statistically processed by an exact probability method. As can be seen from tables 10-13, the latency period of the re-test after 5d in the high-dose mice is longer than that of the control group, the error frequency is less than that of the control group, and the difference is statistically significant (P < 0.05). The number of animals in the dark box at 24h and 5d retesting was statistically insignificant (P > 0.05) compared to the control group for the low, medium and high dose groups.

(4) The results of the water maze test in the first and second tests are shown in tables 14-17.

TABLE 14 Effect of samples on mouse Water maze test: (

N = 10) (first test 5 total results)

TABLE 15 Effect of samples on the mouse Water maze test: (

N = 10) (first test 5d later retest)

TABLE 16 Effect of samples on the mouse Water maze test: (

N = 10) (second test 5 total scores)

TABLE 17 Effect of samples on the mouse Water maze test: (

N = 10) (second test 5d later retest)

Different doses of samples are orally given to the mice for 1 month, in the first test, the time reaching the end point and the error times during retesting after 5d of the water maze test of the mice do not meet the requirement of homogeneity of variance, and statistical treatment is carried out by using the rank sum test. And other indexes meet the requirement of homogeneity of the variance, and statistical treatment is carried out by using a one-factor variance analysis method. The number of animals reaching the endpoint was statistically processed by exact probability. As can be seen from tables 14-17, the number of errors in the 5 total performances and the 5 post-retest error times in the low and high dose groups was less than that in the control group, and the differences were statistically significant (P < 0.05). The number of animals reaching the end point within 2min when retesting after 5d in the high dose group was greater than in the control group, and the difference was statistically significant (P < 0.05).

In the second test, the total score of 5 times in the training period of the mouse water maze test, the time of reaching the end point when retesting after 5d and the error times meet the requirement of homogeneity of variance, a single-factor variance analysis method is used for carrying out statistical treatment, and the number of animals reaching the end point is subjected to statistical treatment by an exact probability method. As can be seen from tables 14-17, the time and error times for the 5 total performances in the training period of the high dose group to reach the end point are less than those of the control group, the error times in the retest after the 5d low dose group and the high dose group are less than those of the control group, and the differences are statistically significant (P < 0.05). The number of animals reaching the end point within 2min of the training period in the low dose group, the medium dose group and the high dose group is greater than that in the control group, and the difference is statistically significant (P < 0.05).

As can be seen from the above results, the dark avoidance test and the water maze test have positive results, and the repeated test results are consistent. According to the judgment of the result of the auxiliary memory improving function test of health food inspection and evaluation technical specification, the preparation with the memory enhancing function provided by the invention has the auxiliary memory improving function under the test condition.

Test 2

Test 4 antioxidant human test

1. Sample (I)

The formulation provided in example 8 and placebo, size 0.5 g/capsule, were taken 2 times daily in humans, 2 capsules each, with a human recommended amount of 2.0 g/person/day.

2. Subject selection

Selecting volunteer subjects from a group with approximately the same influence factors in all aspects in a comparative set; the culture degree is basically consistent; if the Chinese characters belong to the same age group, the corresponding amount is corrected if the Chinese characters are not in the same age group; those who have not received similar tests; the results were not affected by the short-term intake of the test-related products.

3. Test method

The method is carried out according to human body food trial experiment regulations in health food inspection and evaluation technical Specification (200 years edition) for assisting in improving memory function, and the memory quotient of a testee is determined by adopting a clinical memory scale according to test requirements.

4. Test meter

The clinical memory scale revised by the psychological institute of Chinese academy of sciences in 1996 is adopted.

5. Test food design and grouping

Selecting the people who are 18-65 years old, have good physical health condition and are matched with the volunteers under test. The subject gave informed consent. Two control designs, self and group, were used. Randomly dividing the test food group and the control group according to Memory Quotient (MQ), and performing balance test by considering main factors influencing results such as age, gender and the like as much as possible to ensure comparability among the groups. The subjects who completed the feeding trial and included statistics were 102, with 51 subjects in the feeding trial group and 51 subjects in the control group. 102 of the enrollees were enrolled, of which 51 in the diet group, 15 men, 36 women, the average age was 50.8 years; 51 control cases, 16 men and 31 women, mean age 51.1 years old; compared with the control group, the two groups had a balanced comparability of MQ, age, sex and culture degree before eating.

6. Dosage and time of administration

The test group received the test sample and the control group received the placebo. The administration method is oral, 2 times per day, 2 granules each time. The observation time of the test food is 30 days.

7. Safety index and results

(1) General conditions:

the health condition of the subject is inquired in detail before the test, the conditions of the subject such as spirit, sleep, diet, defecation and the like are known, and the weight, the blood pressure, the heart rate and the like are measured. All subjects were subjected to routine physical examination and the necessary laboratory examination.

The subjects were asked for mental, sleep, diet, and stool and urine, and were counted in good, normal, and differential levels, and blood pressure and heart rate were measured. The sample has no adverse effect on the general conditions of human body such as spirit, sleep, diet, blood pressure, heart rate and the like during the test eating period.

(2) Routine examination of blood, urine and feces.

The hematology and blood biochemistry indexes of the test group and the control group are basically in a normal range before and after the test; the urine routine before and after the test feeding of the test feeding group and the control group is basically normal, which shows that the sample has no adverse effect on the blood, urine routine and blood biochemical indexes of the human body.

(3) Chest X-ray, electrocardiogram, and B-ultrasonic examination of abdomen.

No obvious abnormality is found in chest X-ray, electrocardiogram and B-ultrasonic examination of abdomen of two groups of subjects before eating the trial.

8. Efficacy index and results

The clinical memory scale is used and comprises a pointing memory scale score, a associative learning scale score, an image free recall scale score, a meaningless image recognization scale score and a portrait characteristic contact recall scale score. And testing the original sub-scale by using the tested sub-scales, adding the sub-scale to obtain a total scale, and testing the memory quotient by using the total scale.

On the premise that the two groups of memory quotient are balanced before the test, the memory quotient of the test food group after the test food is higher than that of the control group, the difference is significant, and the memory quotient of the test food group after the test food is higher than that of the memory quotient of the test food group before the test food is higher than that of the test food group before the test food is significant, so that the test sample can be judged to have the function of assisting in improving the memory function.

The pointed memory scale score, the associative learning scale score, the image free recall scale score, the meaningless image recall scale score, the human image characteristic associative recall scale score and the influence result of memory quotient are shown in tables 18-23.

Influence of the samples of Table 18 on the pointing memory Scale scores

As can be seen from Table 18, the pre-test group had no statistical significance in comparing the memory-oriented amount to the control group (P > 0.05). After the test diet, the index memory score of the test diet group is higher than that of the control group, and the difference has statistical significance (P < O.US). The self-pairing comparison before and after the test eating is carried out, the difference of the test eating group after the test eating group points to the memory scale is higher than that before the test eating, and the difference has statistical significance (P is less than 0.05); the difference after the reference group was scored on the memory scale was statistically significant (P < 0.05) above before the test diet.

TABLE 19 Effect of samples on associative learning Scale scores

As can be seen from Table 19, the associative study of the pre-test group was not statistically different from the control group (P >0, 05). After the test diet, the association learning scale of the test diet group is higher than that of the control group, and the difference has statistical significance (P is less than 0.05). The self-pairing comparison before and after the test eating is carried out, the difference after the test eating group association learning scale is higher than that before the test eating, and the difference has statistical significance (P is less than 0.05); the difference after the test diet was lower than before the test diet for the associative learning scale of the control group had statistical significance (P < 0.05).

TABLE 20 Effect of samples on image free recall Scale scores

As can be seen from Table 20, the images of the pre-feeding groups showed no statistical difference in the free recall ratio compared to the control group (P > 0.05). After the test diet, the picture of the test diet group is higher than that of the control group in free memory scale, and the difference has statistical significance (P is less than 0.05). The self-pairing comparison before and after the test is carried out, the difference of the test group image after the free memory scale is higher than that before the test is carried out, and the difference has statistical significance (P is less than 0.05); the difference between the control group images after the free memory scale is eaten and before the eating is compared with the control group images before the eating (P > 0.05).

Influence of the Table 21 samples on the meaningless graphical recognizability of the score

As can be seen from Table 21, the meaningless graphical reassurance of the amount in the pre-test group compared to the control group showed no statistical difference (P > 0.05). After the test diet, the meaningless graph reconsideration score of the test diet group is higher than that of the control group, and the difference has statistical significance (P is less than 0.05). Before and after the test eating, the self-pairing comparison is carried out, the meaningless graph of the test eating group is considered, the test eating amount is higher than that before the test eating, and the difference has statistical significance (P is less than 0.05); after reauthentication of the control group's meaningless graph, the differences were statistically insignificant (P > 0.05) compared to pre-test diets.

TABLE 22 influence of samples on human image trait association recall scale scores

As can be seen from Table 22, the image characteristics of the pre-test group were compared with the recall scale and the control group, and the difference was not statistically significant (P > 0.05). After the test diet, the human image characteristics of the test diet group are higher than those of the control group in relation to the recall scale, and the difference has statistical significance (P is less than 0.05). The self-pairing comparison before and after the test eating is carried out, the human image characteristics of the test eating group are higher than those of the test eating group before the test eating in relation with the recall scale, and the difference has statistical significance (P is less than 0.05); the comparison between the human image characteristics of the control group after the dietary test and the human image characteristics of the control group before the dietary test in relation to the recall scale shows that the difference has no statistical significance (P is more than 0.05).

TABLE 23 Effect of samples on memory quotient

As can be seen from Table 23, the difference between the memory quotient of the pre-test group and the control group was not statistically significant (P > 0.05). After the test diet, the memory quotient of the test diet group is higher than that of the control group, and the difference has statistical significance (P is less than 0.05). The self-pairing comparison before and after the test eating is carried out, the difference after the test eating group memorizes the test eating of the merchant is higher than that before the test eating, and the difference has statistical significance (P is less than 0.05); the difference between the control group after the commercial test diet and before the test diet is not statistically significant (P > 0.05).

As can be seen from tables 19-23, comparisons between groups: after the test is eaten, the point memory scale score, the associative learning scale score, the image free recall scale score, the meaningless image recognition scale score, the portrait character associative recall scale score and the memory commercial test eating group are all higher than those of the control group, and the difference has statistical significance (P is less than 0.05). Self pairing comparison: the test food group points to the memory scale score, the association learning scale score, the image free recall scale score, the meaningless graph recognizability scale score, the portrait character association recall scale score and the memory merchant test food, and the difference is higher than that before the test food, and the difference has statistical significance (P is less than 0.05). The difference of the reference group is higher after the reference memory scale is eaten before the reference memory scale is eaten, and is lower than that before the reference memory scale is eaten after the reference memory scale is eaten, the difference of the reference memory scale is eaten before the reference memory scale is eaten, and the difference of the reference memory scale and the reference memory scale is eaten after the reference memory scale is eaten, so that the difference has no statistical significance (P < 0.05), and the comparison difference of other indexes by self pairing has no statistical significance (P > 0.05).

116 people are selected from the test diet group, 58 people are selected from the test diet group, and 58 people are selected from the control group; the subjects who completed the test diet and included the statistics are 102 cases, wherein 51 cases of the test diet group and 51 cases of the control group; 7 patients are out of the test group after the test diet is finished, 7 patients are out of the control group, and the total out-of-date rate is 12.07 percent.

According to the judgment of the results of the human body eating trial test for assisting in improving the memory function in the technical Specification for health food inspection and evaluation (2003 edition), the preparation provided by the embodiment has the function of assisting in improving the memory.

Claims

1. The composition with the memory enhancing effect is characterized by comprising the following raw materials in parts by weight: 115 to 190 parts of DHA algae oil, 100 to 150 parts of lecithin, 15 to 55 parts of taurine, 145 to 220 parts of walnut oil and 5 to 15 parts of beeswax.

2. The composition with the memory enhancing effect as claimed in claim 1, wherein the composition with the memory enhancing effect is prepared from the following raw materials in parts by weight: 130 to 165 parts of DHA algae oil, 110 to 140 parts of lecithin, 20 to 40 parts of taurine, 160 to 200 parts of walnut oil and 8 to 12 parts of beeswax.

3. The composition with the memory enhancing effect as claimed in claim 2, wherein the composition with the memory enhancing effect is prepared from the following raw materials in parts by weight: 150 parts of DHA algal oil, 120 parts of lecithin, 30 parts of taurine, 190 parts of walnut oil and 10 parts of beeswax.

4. A preparation with memory enhancing effect, which is characterized by comprising the composition with memory enhancing effect of any one of claims 1 to 3 and capsule shell material; the weight ratio of the composition with the memory enhancing effect to the capsule shell material is 5:4.

5. the preparation with memory enhancing effect according to claim 4, wherein the capsule shell material is prepared from the following raw materials in a weight ratio of 5:5:2, gelatin and glycerin.

6. A method for preparing the preparation with the effect of enhancing memory according to claim 5, wherein the preparation method comprises the following steps:

1) Preparing the following raw materials in parts by weight according to claim 5: DHA algae oil, walnut oil, beeswax, lecithin, purified water, gelatin and glycerol;

7. The method according to claim 6, wherein the vacuum degree of vacuum degassing in each of the steps 2) and 3) is-0.05 to 0.08MPa.

8. The method according to claim 7, wherein the pelleting conditions in the step 4) are as follows: the temperature is 18-26 ℃, and the relative humidity is 30-40%; the setting conditions are that the temperature is 18-26 ℃ and the relative humidity is 30-40%; the pill washing adopts 95% alcohol; the drying conditions are as follows: the time is 10 to 25 hours, the temperature is 24 to 28 ℃, and the relative humidity is 18 to 30 percent.