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CN101849990A - Pharmaceutical composition with function of improving memory and preparation method thereof - Google Patents

Pharmaceutical composition with function of improving memory and preparation method thereof Download PDF

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Publication number
CN101849990A
CN101849990A CN200910081284A CN200910081284A CN101849990A CN 101849990 A CN101849990 A CN 101849990A CN 200910081284 A CN200910081284 A CN 200910081284A CN 200910081284 A CN200910081284 A CN 200910081284A CN 101849990 A CN101849990 A CN 101849990A
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test
pharmaceutical composition
lecithin
vitamin
memory
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Inventor
李仕幸
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Beijing Increase Pharmaceutical Technology Co Ltd
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Beijing Increase Pharmaceutical Technology Co Ltd
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Abstract

The invention discloses a pharmaceutical composition with a function of improving the memory and a preparation method thereof. The pharmaceutical composition is prepared with the following raw materials according to a certain weight ratio: lecithin, taurine, flaxseed oil and vitamin E. Moreover, the pharmaceutical composition is prepared as soft capsules and has the function of assisting to improve the human memory.

Description

A kind of have pharmaceutical composition of improving the memory function and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition of improving the memory function and preparation method thereof that has.The invention belongs to field of health care food.
Background technology
Along with the continuous development of present society, people are working condition, quality of life increasingly competitive of self, make spirit in tension always, thereby cause harmful effects such as hypomnesis.In addition, the old people is owing to brain aging, and the child is because factors such as malnutrition also all can cause the situation of hypomnesis.Though occurred much having the memory of improvement health care foods in the market, it is single all to exist prescription, shortcomings such as DeGrain.So develop a kind of enhancing brain function that has simultaneously, delay brain aging, the health food that improves effects such as insomnia forgetfulness, neurasthenia and raising intelligence is particularly important.
Summary of the invention
Purpose of the present invention just provides a kind of pharmaceutical composition that improves the memory function that has.
Another object of the present invention has provided this preparation of drug combination method.
The present invention is achieved by the following technical solutions:
A kind of have a pharmaceutical composition that improves the memory function: be made up of lecithin, taurine, oleum lini and vitamin E.
Be preferably: lecithin 2-10 part, taurine 1-8 part, oleum lini 1-5 part, vitamin E 0.005-0.03 part.
More preferably: lecithin 4-7.5 part, taurine 3-5 part, oleum lini 2.5-4 part, vitamin E 0.01-0.02 part.
Described preparation of drug combination method, step is as follows:
Lecithin, taurine, oleum lini and vitamin E are put into rustless steel container by formula proportion, stir, be heated to 40 ℃ stand-by.Mixed liquor after the heating grinds well with colloid mill, transfers bubble, reduces to room temperature, gets medicinal liquid, and is standby.Other gets gelatin, glycerol, water, antiseptic and puts in right amount and be heated to 80 ℃ of dissolvings in the appropriate vessel, filter, rubber solution, 60 ℃ of insulations are standby; Get above-mentioned medicinal liquid and rubber solution, be pressed into ball, be drying to obtain with the soft capsule production equipment.
Each drug mechanism is as follows among the present invention:
Lecithin: being described as and protein, vitamin " the 3rd nutrient " arranged side by side, is the basic substance of life.Lecithin is present among each cell, more is to concentrate on vitals such as brain and nervous system, blood circulation, immune system and liver, the heart, kidney.Lecithin is one of important member in the phospholipid family, and brain is to contain the maximum organ of phospholipid.Lecithin can be kept the brain cell normal function, for neurocyte furnishes ample material, strengthens brain and neural function.Information transmission speed between the cerebral nerve is accelerated, made the people resourceful, the brain vigor obviously improves; Can eliminate brain fag, improve learning capacity and work efficiency, improve attention.
Taurine: the content of taurine in brain is abundant, widely distributed, can obviously promote neural growth promoter and cell proliferation, differentiation, and be dose dependent, plays an important role in the cranial nerve cell growth course.Can effectively promote the cerebral tissue and the intelligence development of infant.Taurine can also promote pituitary hormone secretion in addition, the activation pancreatic function, thereby improve the state of organism endocrine system, to organism metabolism with useful adjusting; And enhancing and antifatigue effect with promotion organism immunity.
Oleum lini: contain abundant alpha-linolenic acid, alpha-linolenic acid is to maintain the life core substance that human brain is evolved, and is the important component that constitutes human tissue cell.It still maintains human body and evolves, the essential fatty acid that keeps fit, participate in vivo phospholipid synthetic, metabolism, be converted into the vital activity factor D HA and the EPA of needed by human, be basic, the most primary material in the life evolutionary process.Alpha-linolenic acid has very strong growth intelligence, vision protection, blood fat reducing, cholesterol, slow down aging, antiallergic, effects such as the generation of inhibition cancer and transfer.
Vitamin E: vitamin E acts on the most extensive in human body, and is all bigger than any nutrient, so the title of " escorting ambassador " is arranged.In health, have good non-oxidizability, promptly reduce cell senescence, promote cell synthetic, the effect of antipollution etc.Share with above-mentioned three kinds of compositionss, can better promote human body to synthesize DHA, thereby improve quality of life.
The present invention relates to a kind of pharmaceutical composition that is used to improve memory, is a kind of nutrient substance that has no side effect of pure natural, is different from the like product of being made by chemical constituent.
Below example illustrates beneficial effect of the present invention by experiment.
Soft capsule with the preparation of the method for the embodiment of the invention 1 experimentizes:
Experimental example:
Human trial is the result show, the experimenter takes soft capsule content of the present invention after 30 days continuously, each subtest scale score of test group and memory quotient and take preceding comparison, all be higher than test before, and difference has significance (P<0.01 or P<0.05).According to " health food check and assessment technique standard " evaluation criterion, the effect of pointing out soft capsule content of the present invention to have auxiliary improvement human body memory function.
Soft capsule content auxiliary improving memory function human experiment laboratory report of the present invention
Sample
Soft capsule content of the present invention and placebo, random labelling are No. 1, No. 2.
The experimenter
Be selected from certain middle school student, healthy, no dysnoesia, informed consent also is ready to give one's cooperation, and the age was not accepted similarly test between 12-14 year, and did not take medicine or the health food relevant with improving memory in 1 year.
Experimental design and grouping
Adopt contrast, double blinding, method for designing at random.Method by cluster at random extracts two classes of the same grade from certain middle school, the colony that living environment is close, carry out the test first time before the clothes sample, just line up by memory quotient,, even number strange by ordering is divided into two groups, and randomly drawing wherein one group then is test group, and another group is matched group, test group 50 people wherein, matched group 50 people.
Test method
With the compound 100 routine trial volunteers of including standard in and guaranteeing compatibility test, be divided at random and be subjected to examination group and matched group.Be subjected to examination group and matched group that above-mentioned sample that provides and placebo all are provided, every day 2 times, each 1, observed continuously 30 days.
Key instrument, reagent and test environment require:
Test equipment:
(1) record has the memory of sensing and the instruction of learning by association and the tape of stimulus words;
(2) picture material: random shape is re-recognized picture, is equipped with to present for the first time with 20 in target stimulus picture, and being equipped with to present with target stimulus when re-recognizing for the second time and sneak into stimulates each 20 in picture, totally 40, adds up to 60 pictures (branch first, second two covers); Free recall each 15 in two groups in image picture of image, totally 30 (dividing first, second two covers); Picture is recalled in the contact of portrait characteristics, is used black and white for the first time fully and delineates people's face as 6, and the people's face that presents when recalling fully is as 6, and both contents are identical, order is different, amount to 12; Every portrait picture back side indicates surname, occupation, hobby, the characteristics (branch first, second two covers) of this portrait.
(3) machine, stopwatch, recorder chart between the record.
Method of testing: for avoiding existing between first, the second two cover test questions influence of difficulty or ease difference, half experimenter is for the first time with first cover topic during test, and with second cover topic, second half experimenter with second cover topic, inscribes with the first cover for the first time for the second time for the second time.Forward and backward twice test of each experimenter reduces systematic error by same experimenter testing.The test time point: forward and backward twice test of each experimenter carried out at same time point, avoids the influence of biorhythm.When testing for the second time, the experimenter does not see the grouping list, blind method test.
General requirement during test: test by the personnel that were subjected to specialized training; Test should be carried out in a quiet room.Except that experimenter and experimenter, avoided other people on the scene as far as possible; Three subtests relevant with vision are arranged in this scale, and indoor light must guarantee to see clearly Chu stimulates picture; Get rid of because of audition or dysphotia as far as possible and influence the memory achievement; Must be noted that the mental status the when experimenter is tested, carry out under the situation that test needs normally, not oppose to accept to test in experimenter's emotion, attention is relatively concentrated; Whether whether whether the experimenter is tired, and whether attention is concentrated, cooperate, nervous to test, and whether confident the grade all need be recorded on the homepage of recorder chart; Same experimenter's test request is once finished; When comparing the subtest achievement, must be noted that what whether different subtests carried out under the identical mental status with the age scale branch.Errorless can the inserting in the original subitem of original branch check of every subtest achievement.
Data processing method: will record branch (original branch) and be converted into scale score, the scale score of every subtest between comparing two groups, calculate total scale score, check in after the memory quotient the relatively difference between two groups, the contrast dual mode carries out statistical analysis between employing own control and group, eliminates the influence of transfer learning.
Observation index
Each measures once every observation index when test-meal on-test and end.
Safety indexes
Ordinary circumstance: perquisition experimenter health status before the test, situations such as understanding experimenter's spirit, sleep, diet, defecation.
Routine blood test: red blood cell count(RBC), numeration of leukocyte, content of hemoglobin mensuration etc.
Routine urinalysis: pH value, leukocyte etc.
Stool for routine: worm's ovum inspection etc.
Effect index: use the test of Clinical Memory scale, look into scale score with the original branch of each subtest after the test: sensing memory, learning by association, image are freed recall, random shape is re-recognized, the contact of portrait characteristics is recalled.Each subtest scale score addition gets total scale score, looks into memory quotient with total scale score.
Data statistics: this test data is a measurement data; Can analyze with the t check two groups of each subtest scale scores and memory quotient.Own control can adopt paired t-test, the parallel t check of relatively adopting two sample means between group, the latter need carry out homogeneity test of variance, and the data of nonnormal distribution or heterogeneity of variance are carried out suitable variable conversion, wait to satisfy normal state or variance neat after, carry out the t check with data converted; If translation data still can not satisfy the neat requirement of normal state variance, use t ' check or rank test instead; But the data that the variation system is too big is used rank test.Add up with the STATA statistical software.
The result judges: before test under two groups of isostatic prerequisites of memory quotient, the memory quotient of test-meal group is higher than matched group after the test-meal, and difference has significance, memory quotient after the test of the group of test-meal simultaneously is higher than the memory quotient before its test, and difference has significance, can judge that this given the test agent has the effect of auxiliary improving memory function.
The result
Double-blind method is observed and is finished to make known: take No. 2 persons and be soft capsule of the present invention, take No. 1 person and be placebo.
Ordinary circumstance: initial trial crowd's test group 50 people, matched group 50 people, after test in 30 days, test group has 1 routine experimenter not screened out entirely because of judging curative effect or data, and matched group has 1 routine experimenter to take because of interruption do not screened out entirely by test product or data.Last efficiency test crowd test group 49 examples, matched group 49 examples.The test group age 13.57 ± 0.53, the matched group age 13.19 ± 0.83; Test group man/woman is 25/24, and matched group man/woman is 28/21.Equal Non Apparent Abnormality such as experimenter's mental status, diet situation, sleep quality and mental activity before and after the test, situations such as its spirit of test back, diet, sleep and mental activity do not have significant change.
Safety is observed
Routine blood test, routine urinalysis, stool routine examination index: see Table 1.
Take and tried thing 1 month, test-meal group and matched group routine blood test, routine urinalysis, stool routine examination index are in normal range: point out soft capsule of the present invention that body health is not had obvious damage.
Routine blood test index situation of change before and after table 1 test-meal (X ± S)
Figure B2009100812840D0000051
Soft capsule of the present invention sees Table 2-7 to the influence of human body memory effect index.
Table 2 soft capsule of the present invention is to the influence of pointing to the memory scale score (X ± SD)
Figure B2009100812840D0000052
By table 2 as seen, the sensing of test group memory scale score and matched group compare before the test-meal, and difference does not have significance (P>0.05); The sensing of test group memory scale score is significantly higher than matched group (P<0.01) after the test-meal; Relatively, difference has significance (P<0.01) before sensing memory scale score after the test group test-meal and the test-meal.
Table 3 soft capsule of the present invention is to the influence of learning by association scale score (X ± SD)
Figure B2009100812840D0000053
By table 3 as seen, the learning by association scale score of test group and matched group compare before the test-meal, and difference does not have significance (P>0.05); The learning by association scale score of test group and matched group comparing difference have significance (P<0.05) after the test-meal; Relatively, difference has significance (P<0.01) before learning by association scale score after the test group test-meal and the test-meal.
Table 4 soft capsule of the present invention is to the image influence (X ± SD) of scale score that frees recall
Figure B2009100812840D0000054
By table 4 as seen, the image of test group free recall scale score and matched group comparison before the test-meal, difference does not have significance (P>0.05); The image of test group is freed recall scale score and matched group relatively after the test-meal, and difference has significance (P<0.01); Image after the test group test-meal is freed recall before scale score and the test-meal relatively, and difference has significance (P<0.01).
Table 5 soft capsule of the present invention is re-recognized the influence (X ± SD) of scale score to random shape
Figure B2009100812840D0000061
By table 5 as seen, the random shape of the preceding test group of test-meal re-recognizes scale score and matched group compares, and difference does not have significance (P>0.05); Test group and matched group compare after the test-meal, and difference has significance (P<0.05); Random shape after the test group test-meal compares before re-recognizing scale score and test-meal, and difference has significance (P<0.05).
The influence of table 6 soft capsule portrait of the present invention characteristics contact memory scale score (X ± SD)
Figure B2009100812840D0000062
By table 6 as seen, the contact of the portrait characteristics of test group is with recalling scale score and matched group relatively before the test-meal, and difference does not have significance (P>0.05); The portrait characteristics of test group contact memory scale score is significantly higher than matched group (P<0.01) after the test-meal; The contact of portrait characteristics after the test group test-meal is recalled scale score and is significantly higher than (P<0.01) before the test-meal.
Table 7 soft capsule of the present invention is to the influence of memory quotient (X ± SD)
Figure B2009100812840D0000063
By table 7 as seen, the memory quotient of test group and matched group compare before the test-meal, and difference does not have significance (P>0.05); The memory quotient of test group is significantly higher than matched group (P<0.01) after the test-meal; Memory quotient after the test group test-meal is significantly higher than (P<0.01) before the test-meal.
Human trial is the result show, the experimenter takes soft capsule of the present invention after 30 days continuously, and before each subtest scale score and memory quotient all are higher than test-meal after the test group test-meal, and difference has significance; Every test scale score and memory quotient all are higher than matched group after the test group test-meal, and difference all has significance.According to " health food check and assessment technique standard " evaluation criterion, the effect of pointing out soft capsule of the present invention to have auxiliary improvement human body memory function.
The specific embodiment
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1:
5 parts in lecithin, 4.5 parts of taurines, 3.5 parts of oleum linis, vitamin E are put into rustless steel container for 0.01 part in proportion, stir, be heated to 40 ℃ stand-by.Mixed liquor after the heating grinds well with colloid mill, transfers bubble, reduces to room temperature, gets medicinal liquid, and is standby.Other gets gelatin, glycerol, water, antiseptic and puts in right amount and be heated to 80 ℃ of dissolvings in the appropriate vessel, filter, rubber solution, 60 ℃ of insulations are standby; Get above-mentioned medicinal liquid and rubber solution, be pressed into ball, be drying to obtain with the soft capsule production equipment.
Embodiment 2:
5 parts in lecithin, 4.5 parts of taurines, 3 parts of oleum linis, vitamin E are put into rustless steel container for 0.02 part in proportion, stir, be heated to 40 ℃ stand-by.Mixed liquor after the heating grinds well with colloid mill, transfers bubble, reduces to room temperature, gets medicinal liquid, and is standby.Other gets gelatin, glycerol, water, antiseptic and puts in right amount and be heated to 80 ℃ of dissolvings in the appropriate vessel, filter, rubber solution, 60 ℃ of insulations are standby; Get above-mentioned medicinal liquid and rubber solution, be pressed into ball, be drying to obtain with the soft capsule production equipment.
Embodiment 3:
6 parts in lecithin, 4.5 parts of taurines, 3 parts of oleum linis, vitamin E are put into rustless steel container for 0.02 part in proportion, stir, be heated to 40 ℃ stand-by.Mixed liquor after the heating grinds well with colloid mill, transfers bubble, reduces to room temperature, gets medicinal liquid, and is standby.Other gets gelatin, glycerol, water, antiseptic and puts in right amount and be heated to 80 ℃ of dissolvings in the appropriate vessel, filter, rubber solution, 60 ℃ of insulations are standby; Get above-mentioned medicinal liquid and rubber solution, be pressed into ball, be drying to obtain with the soft capsule production equipment.
Embodiment 4:
6 parts in lecithin, 4 parts of taurines, 3 parts of oleum linis, vitamin E are put into rustless steel container for 0.02 part in proportion, stir, be heated to 40 ℃ stand-by.Mixed liquor after the heating grinds well with colloid mill, transfers bubble, reduces to room temperature, gets medicinal liquid, and is standby.Other gets gelatin, glycerol, water, antiseptic and puts in right amount and be heated to 80 ℃ of dissolvings in the appropriate vessel, filter, rubber solution, 60 ℃ of insulations are standby; Get above-mentioned medicinal liquid and rubber solution, be pressed into ball, be drying to obtain with the soft capsule production equipment.

Claims (7)

1. one kind has the pharmaceutical composition that improves the memory function, it is characterized in that, this pharmaceutical composition is made up of lecithin, taurine, oleum lini and vitamin E.
2. pharmaceutical composition according to claim 1 is characterized in that, lecithin 2-10 part, taurine 1-8 part, oleum lini 1-5 part, vitamin E 0.005-0.03 part.
3. pharmaceutical composition according to claim 1 is characterized in that, lecithin 4-7.5 part, taurine 3-5 part, oleum lini 2.5-4 part, vitamin E 0.01-0.02 part.
4. according to the described pharmaceutical composition of claim 1-3, it is characterized in that, be prepared into acceptable clinically peroral dosage form, as granule, tablet, capsule, soft capsule, oral liquid, pill, powder, drop pill etc.
5. according to the described pharmaceutical composition of claim 1-3, it is characterized in that, be prepared into soft capsule.
6. according to the described preparation of drug combination method of claim 1-3, it is characterized in that, lecithin, taurine, oleum lini and vitamin E put into rustless steel container by formula proportion, stir, be heated to 40 ℃ stand-by.Mixed liquor after the heating grinds well with colloid mill, transfers bubble, reduces to room temperature, gets medicinal liquid, and is standby.Other gets gelatin, glycerol, water, antiseptic and puts in right amount and be heated to 80 ℃ of dissolvings in the appropriate vessel, filter, rubber solution, 60 ℃ of insulations are standby; Get above-mentioned medicinal liquid and rubber solution, be pressed into ball, be drying to obtain with the soft capsule production equipment.
7. the described pharmaceutical composition of claim 1-3 is used to prepare the application that improves memory, promotion child and teenager brain development, delays old people's brain aging.
CN200910081284A 2009-03-31 2009-03-31 Pharmaceutical composition with function of improving memory and preparation method thereof Pending CN101849990A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102652815A (en) * 2012-05-09 2012-09-05 武汉市健恒生物科技有限责任公司 Medicament composite for improving memory as well as preparation method and application thereof
CN103393702A (en) * 2013-08-16 2013-11-20 中国人民解放军兰州军区乌鲁木齐总医院 Drug composition for enhancing memory of people rapidly exposed to high altitude, and preparation method thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1582947A (en) * 2004-05-26 2005-02-23 内蒙古草原兴发股份有限公司 Capsules of alpha-linolinic acid
CN1679593A (en) * 2005-02-04 2005-10-12 海南国栋药物研究所有限公司 Composite preparation containing alpha-linolenic acid free acid, soybean phospholipid and vitamin E

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1582947A (en) * 2004-05-26 2005-02-23 内蒙古草原兴发股份有限公司 Capsules of alpha-linolinic acid
CN1679593A (en) * 2005-02-04 2005-10-12 海南国栋药物研究所有限公司 Composite preparation containing alpha-linolenic acid free acid, soybean phospholipid and vitamin E

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102652815A (en) * 2012-05-09 2012-09-05 武汉市健恒生物科技有限责任公司 Medicament composite for improving memory as well as preparation method and application thereof
CN102652815B (en) * 2012-05-09 2013-11-06 武汉市健恒生物科技有限责任公司 Medicament composite for improving memory as well as preparation method and application thereof
CN103393702A (en) * 2013-08-16 2013-11-20 中国人民解放军兰州军区乌鲁木齐总医院 Drug composition for enhancing memory of people rapidly exposed to high altitude, and preparation method thereof
CN103393702B (en) * 2013-08-16 2016-01-13 中国人民解放军兰州军区乌鲁木齐总医院 A kind ofly strengthen pharmaceutical composition of Acute Exposed Altitude crowd memory and preparation method thereof

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Application publication date: 20101006