CN102652815A - Medicament composite for improving memory as well as preparation method and application thereof - Google Patents
Medicament composite for improving memory as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a medicament composite and a preparation method thereof, wherein the medicament composite is prepared from bulk drugs as follows: bitter caramon, Chinese dates, soya lecithin, fish oil and taurine. The preparation method comprises the following steps of: adding water, and performing distilling, extracting, filtrating, concentrating, mixing and the like on the bulk drugs, adding general auxiliary materials, and preparing capsules, granules, troche, pills, oral administration liquid preparations or injections according to the conventional process. The medicament composite provided by the invention can improve the memory, the quality is stable, the effect is exact, and the security is high.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, particularly a kind of pharmaceutical composition that has raising and improve memory function.
Background technology
Dysmnesia refer to that the individual is in a kind ofly can not be remembered or the state of memory information or technical ability, might be the permanent or temporary dysmnesia that cause owing to reason Pathophysiology property or situation property.Hypomnesis is a kind of dysmnesia, morely clinically sees, can show as going down of memory far away and nearly memory.Cause the reason of hypomnesis to have a variety of.Note not concentrating causing hypomnesis during the normal because memorize of neurastheniac; Brain organic disease patient then be owing to the brain cell damage effect memory the maintenance process cause hypomnesis; Human various function reduction and physiologic derangement phenomenon appear in body in aging course, and learning and memory is accompanied by the aging of body, also can fade; In addition, because factors such as learning life cause spiritual high-pressure, or brain overwork makes neural fatigue also can cause hypomnesis continuously.
In recent years, since the development of aged tendency of population, the increase of rhythm of life quickening and learning life pressure, and the people of hypomnesis is more and more.Improving and improve and remember, is a lot of hypomnesis persons, especially old people and student's urgent hope.Active drug and health food that research and development help to improve and improve memory become the problem that modern medicine is paid close attention to.
Summary of the invention
The objective of the invention is to disclose a kind of pharmaceutical composition, another purpose of the present invention is to disclose this preparation of drug combination method, the present invention also aims to disclose the purposes of this pharmaceutical composition.。
The present invention seeks to realize through following technical scheme:
Pharmaceutical composition crude drug of the present invention consists of:
Fructus Alpiniae Oxyphyllae 30-80 weight portion Fructus Jujubae 10-50 weight portion soybean phospholipid 5-30 weight portion
Fish oil 5-15 weight portion taurine 2-10 weight portion
Pharmaceutical composition crude drug composition of the present invention is preferably:
Fructus Alpiniae Oxyphyllae 50 weight portion Fructus Jujubaes 30 weight portion soybean phospholipids 15 weight portions
Fish oil 10 weight portion taurines 5 weight portions
Pharmaceutical composition crude drug composition of the present invention is preferably:
Fructus Alpiniae Oxyphyllae 40 weight portion Fructus Jujubaes 40 weight portion soybean phospholipids 28 weight portions
Fish oil 8 weight portion taurines 8 weight portions
Pharmaceutical composition crude drug composition of the present invention is preferably:
Fructus Alpiniae Oxyphyllae 70 weight portion Fructus Jujubaes 15 weight portion soybean phospholipids 18 weight portions
Fish oil 12 weight portion taurines 8 weight portions
Get the above-mentioned raw materials medicine, add conventional adjuvant, process capsule, granule, tablet, pill, slow releasing preparation, oral liquid or injection according to common process.
Preparation of drug combination method of the present invention comprises the steps:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 6-10 times of weight water distillation 2-4 hour, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 6-10 times of weight decocting and boil 1-3 time, and each 0.5-1.5 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
B, get 6 ~ 48 weight portion starch and 1 ~ 9 weight portion micropowder silica gel, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use or get formula ratio fish oil and add conventional adjuvant, is prepared into Powdered fish oil, subsequent use;
The processing of C, soybean phospholipid: with the starch mix homogeneously of formula ratio soybean phospholipid and 10 ~ 50 weight portions, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: the formula ratio taurine is pulverized, crossed 80 mesh sieves, subsequent use;
E, with the fish oil of handling well among step B, C, the D or fish oil powder, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, with subsequent use granule, add 0.2 ~ 3 parts by weight of micro silica gel powder mix homogeneously, add conventional adjuvant, process capsule, granule, tablet, pill, slow releasing preparation, oral liquid or injection according to common process.
The preferred following steps of preparation of drug combination method of the present invention:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
The processing of B, fish oil: get 20 weight portion starch, 5 weight portion micropowder silica gels, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use; Or get formula ratio fish oil and add conventional adjuvant, be prepared into Powdered fish oil, subsequent use;
The processing of C, soybean phospholipid: with the formula ratio soybean phospholipid, add 20 weight portion starch mix homogeneously, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: the formula ratio taurine is pulverized, crossed 80 mesh sieves, subsequent use;
E, with the fish oil of handling well among step B, C, the D or fish oil powder, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, with subsequent use granule and 1 parts by weight of micro silica gel powder mix homogeneously, add conventional adjuvant, process capsule, granule, tablet, pill, slow releasing preparation, oral liquid or injection according to common process.
Preparation of drug combination method of the present invention is following steps preferably:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 6 times of weight water distillation 3.5 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 9 times of weight decoctings and boil 2 times, and each 0.5 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
The processing of B, fish oil: get 12 weight portion starch and 7 parts by weight of micro silica gel powder, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use; Or get formula ratio fish oil and add conventional adjuvant, be prepared into Powdered fish oil, subsequent use;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 25 weight portion starch mix homogeneously, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is subsequent use;
E, with the fish oil of handling well among step B, C, the D or fish oil powder, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, with subsequent use granule and 1.5 parts by weight of micro silica gel powder mix homogeneously, add conventional adjuvant, process capsule, granule, tablet, pill, slow releasing preparation, oral liquid or injection according to common process.
Pharmaceutical composition of the present invention has the function that improves and improve memory, steady quality, and exact efficacy, safe.
Experiment and embodiment are used to further specify but are not limited to the present invention below.
Experimental example one: Ergonomy experiment
1 material
1.1 sample: pharmaceutical composition of the present invention (embodiment 1 preparation) is a hard capsule, and content is faint yellow to sepia coarse powder or granule, and net content is the 0.3g/ grain.Room temperature preservation is for experiment.
1.2 laboratory animal: provide by Hubei Province's Experimental Animal Center, SPF level Kunming mouse, body weight 18-22g, female, 240, animal credit number: SYXK (Hubei Province) 2003-0014 number, 24 ℃ of experimental temperature: 22-, humidity 65-80%.
1.3 dosage is selected: human body recommended amounts every day is 1.8g/30kgBW, establishes basic, normal, high three dosage with these 10,20,30 times, is respectively 0.6,1.2, l.8g/kgBW.Press the volume of 0.2ml/10gBW and irritate the stomach mice, be made into respective concentration with distilled water, matched group is irritated the stomach distilled water, and the filling gastric capacity is identical with the animal subject group, continuous irrigation stomach 30 days
1.4 instrument: the diving tower appearance, keep away dark appearance, water maze.
2 experimental techniques
2.1 step down test:
Body weight 18-22g Kunming mouse is divided into 0.6,1.2, l.8g/kgBW three dose groups and a blank group at random, and each dose groups animal is 10 every group.The continuous irrigation stomach carries out the diving tower training after 30 days.Animal was put into the reaction chamber endoadaptation 3 minutes, passes to 36 volts of alternating currents immediately, write down the number of times (errors number of animal) that every Mus is shocked by electricity in 3 minutes, with this as school grade.Cyclical test after 24 hours, is for the first time jumped off errors number in incubation period and 3 minutes of platform at the number of animals that record is shocked by electricity.
2.2 keep away dark test:
Animal is selected, and test is divided into groups, all same step down test of dosage, approach, time.The continuous irrigation stomach begins to keep away dark training after 30 days, write down every Mus and shocked by electricity required time, i.e. incubation period from putting into entering darkroom, bright chamber.Cyclical test after 24 hours, the number of animals that writes down the errors number in incubation period, 5 minutes of every Mus and get into the darkroom.
2.3 water maze test:
Animal is selected, and test is divided into groups, all same step down test of dosage, approach, time.The continuous irrigation stomach begins training after 30 days, the training period successive administration, once a day.Labyrinth swimming lane depth of water 9cm, 25 ± 1 ℃ of water temperatures.Before the training animal is placed near the ladder for the first time, it is climbed up 3 times automatically, before each later on training animal is placed near the ladder, it is climbed up 1 time automatically.Training is carried out stage by stage, and apparent motion thing school grade progressively increases the lengthening distance.The beginning at A place when training for the first time, training lengthening distance begins from B for the second time, and this distance is trained 3 times approximately, trains altogether 4 times, reaches home to 80% above animal.Last is trained from starting point, writes down the errors number of every animal, the time of reaching home and number of animals.Remember the test of disappearing after one week.
2.4 the processing of experimental data:
Experimental data adopts variance analysis or X
2Check analysis is handled.
3 results
3.1 influence to the mice body weight:
Table 1 pharmaceutical composition of the present invention is to the influence of mice body weight---active experiment (water maze test)
Table 2 pharmaceutical composition of the present invention is to the influence of mice body weight---by dynamic test (step down test)
Table 3 pharmaceutical composition of the present invention is to the influence of mice body weight---by dynamic test (keeping away dark test)
Visible by table 1, table 2, table 3; Pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days; Active experiment (water maze test) and by each dose groups the weight of animals of dynamic test (step down test with keep away dark test) and matched group comparison, there are no significant for difference (P＞0.05).
3.2 influence---water maze test to the mouse memory acquisition:
Influence---the water maze test that table 4 pharmaceutical composition of the present invention obtains mouse memory
Visible by table 4, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, and time that each dose groups mice of active experiment (water maze test) is reached home and errors number are all less than matched group; Wherein, Middle and high dose groups and matched group compare, and difference all has significance (P＜0.05, P＜0.05).The number of animals of reaching home in the 2min and matched group relatively, each dose groups all has growth, but difference there are no significant (P＞0.05).
3.3 influence to the mouse memory acquisition---keep away dark test:
Table 5 pharmaceutical composition of the present invention is kept away the preclinical influence of dark test to mice
Visible by table 5, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, in keeping away dark test; Incubation period and matched group compare during each dose groups training of mice, and there are no significant for difference (P＞0.05), tests incubation period after 24 hours; Each dose groups and matched group are relatively; Difference all has significance (P＜0.05, P＜0.05, P＜0.05).
Table 6 pharmaceutical composition of the present invention is kept away the influence of dark experimental mistake number of times to mice
Visible by table 6, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, in keeping away dark test; Average error number of times and matched group compare during each dose groups training of mice, and there are no significant for difference (P＞0.05), test average error number of times after 24 hours; Each dose groups is all less than matched group; Wherein, high dose group and matched group compare, and difference has significance (P＜0.05).
Table 7 pharmaceutical composition of the present invention is kept away the influence of dark experimental mistake response rate to mice
Visible by table 7; Pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, and in keeping away dark test, wrong reaction rate and matched group are relatively during each dose groups training of mice; There are no significant for difference (P＞0.05); Test wrong reaction rate after 24 hours, each dose groups is all less than matched group, and there are no significant for difference (P＞0.05).
3.4 influence---step down test to the mouse memory acquisition:
Table 8 pharmaceutical composition of the present invention is to the preclinical influence of mice step down test
Visible by table 8, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, in step down test; Incubation period and matched group are relatively during each dose groups training of mice; There are no significant for difference (P＞0.05), tests incubation period after 24 hours, and each dose groups all is longer than matched group incubation period.Wherein, middle and high dose groups and matched group compare, and difference has significance (P＜0.05, P＜0.05).
Table 9 pharmaceutical composition of the present invention is to the influence of mice step down test errors number
Visible by table 9, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, and in step down test, average error number of times and matched group compare during each dose groups training of mice, and there are no significant for difference (P＞0.05).Test average error number of times after 24 hours, each dose groups is all less than matched group, and wherein, high dose group and matched group compare, and difference has significance (P＜0.05).
Table 10 pharmaceutical composition of the present invention is to the influence of mice step down test wrong reaction rate
Visible by table 10, pharmaceutical composition continuous irrigation stomach of the present invention in step down test, was test wrong reaction rate and matched group relatively after 30 days when each dose groups of mice is trained and after 24 hours, and there are no significant for difference (P＞0.05).
3.5 the result of repeated trials
For checking the repeatability of above test, above test is carried out once again.
Table 11 pharmaceutical composition of the present invention is to the influence of mice body weight---water maze (repetition) test
Table 12 pharmaceutical composition of the present invention is to the influence of mice body weight---diving tower (repetition) test
Table 13 pharmaceutical composition of the present invention is to the influence of mice body weight---keep away dark (repetition) test
Visible by table 11, table 12, table 13; Pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days; Water maze (repetition) test, diving tower (repetition) are tested, are kept away dark (repetition) and test each dose groups the weight of animals and matched group comparison, and there are no significant for difference (P＞0.05).
The influence that table 14 pharmaceutical composition of the present invention obtains mouse memory---water maze (repetition) test
Visible by table 14, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, and water maze (repetition) is tested time that each dose groups mice reaches home and errors number all less than matched group; Wherein, Middle and high dose groups and matched group compare, and difference all has significance (P＜0.05, P＜0.05).The number of animals of reaching home in the 2min and matched group relatively, each dose groups all has growth, but difference there are no significant (P＞0.05).
Table 15 pharmaceutical composition of the present invention is kept away secretly (repetition) to mice and is tested preclinical influence
Visible by table 15, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, in keeping away dark (repetition) test; Incubation period and matched group compare during each dose groups training of mice, and there are no significant for difference (P＞0.05), tests incubation period after 24 hours; Each dose groups and matched group are relatively; Difference all has significance (P＜0.05, P＜0.05, P＜0.01).
Table 16 pharmaceutical composition of the present invention is kept away the influence of (repetition) dark experimental mistake number of times to mice
Visible by table 16, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, in keeping away dark (repetition) test; Average error number of times and matched group compare during each dose groups training of mice, and there are no significant for difference (P＞0.05), test average error number of times after 24 hours; Each dose groups is all less than matched group; Wherein, high dose group and matched group compare, and difference has significance (P＜0.05).
Table 17 pharmaceutical composition of the present invention is kept away the influence of secretly (repetition) experimental mistake response rate to mice
Visible by table 17; Pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, and in keeping away (repetition) dark test, wrong reaction rate and matched group are relatively during each dose groups training of mice; There are no significant for difference (P＞0.05); Test wrong reaction rate after 24 hours, each dose groups is all less than matched group, and there are no significant for difference (P＞0.05).
Table 18 pharmaceutical composition of the present invention to the mice diving tower (repetition) test preclinical influence
Visible by table 18, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, in diving tower (repetition) test; Incubation period and matched group compare during each dose groups training of mice, and there are no significant for difference (P＞0.05), tests incubation period after 24 hours; Each dose groups all is longer than matched group incubation period; With the matched group comparing difference significance (P＜0.05, P＜0.05, P＜0.05) is arranged all.
Table 19 pharmaceutical composition of the present invention is to the influence of mice diving tower (repetition) experimental mistake number of times
Visible by table 19, pharmaceutical composition continuous irrigation stomach of the present invention is after 30 days, and in diving tower (repetition) test, average error number of times and matched group compare during each dose groups training of mice, and there are no significant for difference (P＞0.05).Test average error number of times after 24 hours, each dose groups is all less than matched group, and wherein, high dose group and matched group compare, and difference has significance (P＜0.05).
Table 20 pharmaceutical composition of the present invention is to the influence of mice diving tower (repetition) experimental mistake response rate
Visible by table 20, pharmaceutical composition continuous irrigation stomach of the present invention in diving tower (repetition) test, was test wrong reaction rate and matched group relatively after 30 days when each dose groups of mice is trained and after 24 hours, and there are no significant for difference (P＞0.05).4 conclusions
Pharmaceutical composition human body recommended amounts every day of the present invention is 1.8g/30kgBW, establishes basic, normal, high three dosage with these 10,20,30 times, is respectively 0.6,1.2, l.8g/kgBW.Press the volume of 0.2ml/10gBW and irritate stomach SPF level Kunming mouse, be made into respective concentration with distilled water, matched group is irritated the stomach distilled water, and the filling gastric capacity is identical with the animal subject group, continuous irrigation stomach 30 days.The result shows:
(1) each dose groups compares the influence and the matched group of mice body weight, and there are no significant for difference (P＞0.05);
(2) in water maze test, time and errors number that middle and high dose groups mice is reached home all are significantly less than matched group, compare with matched group, and difference has significance (P＜0.05, P＜0.05).And the repeated trials result is consistent;
(3) in keeping away dark test, compare with matched group the incubation period that the equal ability of each dose groups significant prolongation mice was test after 24 hours, difference has significance (P＜0.05, P＜0.05, P＜0.05).Test average error number of times after 24 hours, each dose groups is all less than matched group, and wherein, high dose group and matched group compare, and difference has significance (P＜0.05).And the repeated trials result is consistent;
(4) in step down test, compare with matched group the incubation period that the equal ability of each dose groups significant prolongation mice was test after 24 hours, difference has significance (P＜0.05, P＜0.05, P＜0.05).Test average error number of times after 24 hours, each dose groups is all less than matched group, and wherein, high dose group and matched group compare, and difference has significance (P＜0.05).And the repeated trials result is consistent.
Above result of the test shows that pharmaceutical composition of the present invention has raising and improves memory impairments SPF level Kunming mouse.
Experimental example two: clinical experimental study
1 material and method
1.1 sample: pharmaceutical composition of the present invention (according to embodiment one preparation) and placebo sample lot number: 20051201.Two kinds of basic zero differences of sample packaging, profile and character.
1.2 test material: record has the instruction of memory pointed to and learning by association and tape, picture material (branch first, second two covers), recorder, stopwatch, the recorder chart of stimulus words.
1.3 subjects: select 16 ~ 18 years old age Sophomore 110 people as subjects.Subjects schooling basically identical is not accepted similar test, does not take medicine or the health food relevant with these article function in a short time.
1.4 test is divided into groups and usage and dosage: double-blind method is adopted in this test, at random the experimenter is divided into 2 groups, gets rid of and ends the experimenter midway for some reason, actual experiment group 55 examples, matched group 50 examples.Test group is taken doubly agile capsule, and matched group is taken placebo, every day 3 times, each 2.45 days observing times
2 observation index
2.1 safety indexes
2.1.1 general situation comprises spirit, sleep, diet, defecation, blood pressure etc.
2.1.2 blood, urine, just routine examination
2.1.3 liver, kidney function test
2.1.4 Chest X-rays, electrocardiogram, Abdominal B type ultrasonography inspection (pretest inspection once)
2.2 effect index: unified use Chinese Academy of Sciences's psychology the Clinical Memory scale.The original branch of each subtest with after the test is looked into scale score, and each subtest scale score addition gets total scale score, looks into memory quotient according to total scale score.The effect index is following
2.2.1 point to the memory scale score
2.2.2 learning by association scale score
The scale score 2.2.3 image is freed recall
2.2.4 random shape is re-recognized scale score
2.2.5 scale score is recalled in the contact of portrait characteristics
2.2.6 memory quotient
2.3 date processing: this test data is a measurement data, and two groups of each subtest scale scores and memory quotient are analyzed with the t check.Own control is adopted 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 or variance, use t instead
2Check or rank test; But the coefficient of variation too data of big (like CV＞50%) is used rank test.
2.4 the result judges: before test under two groups of isostatic prerequisites of memory quotient; The memory quotient of test back test group is higher than matched group; And difference has significance; Memory quotient after the test group test simultaneously is higher than the memory quotient before the test, and difference has significance, can judge that sample has the memory impairments of improvement.
3. result
3.1 physical data: situations such as test back test group spirit, sleep, diet all have certain improvement, compare with matched group, and difference does not have significance.
3.2 safety indexes observed result
Hemogram and liver, renal function change (X ± SD) before and after table 21 test-meal
Large and small just routine and electrocardiogram, Chest X-rays, ultrasound diagnosis result before and after table 22 test-meal
3.3 effect index observing result
Each group memory scale score before table 23 test-meal (X ± SD)
Each group memory scale score after table 24 test-meal (X ± SD)
Compare * * P＜0.01 before and after the test, * P＜0.05
The comparison of memory quotient before and after table 25 test (X ± SD)
Compare * * P＜0.01 before and after the test, compare ##P＜0.01 between test group,
3. brief summary
Select 110 high school students, at random, the double-blind trial method is divided into test group and matched group, actually go into group 105 people, test group 55 people, matched group 50 people.Adopt Chinese Academy of Sciences's psychology the Clinical Memory scale carry out the test of memory quotient.Result of the test is: it is balanced to test preceding two groups of memory quotient; The difference (the P value is all less than 0.01) that highly significant is more all arranged before and after the index tests such as the sensing memory of test group, learning by association, image are freed recall, random shape is re-recognized, the contact of portrait characteristics is recalled, total scale score, memory quotient; Except that image was freed recall, other indexs and matched group more all had the difference (the P value is all less than 0.01) of highly significant; Before and after the test, each safety indexes does not all produce ANOMALOUS VARIATIONS, does not observe untoward reaction.The result shows that pharmaceutical composition of the present invention has the function that improves and improve memory, and safety is good.
Following embodiment all can realize the effect of above-mentioned experimental example.
Embodiment one: the preparation of medicament composition capsule agent of the present invention
Fructus Alpiniae Oxyphyllae 50g Fructus Jujubae 30g soybean phospholipid 15g
Fish oil 10g taurine 5g
Preparation of pharmaceutical compositions method of the present invention comprises the steps:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
The processing of B, fish oil: get 20g starch and 5g micropowder silica gel, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 20g starch mix homogeneously, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is subsequent use;
E, with the fish oil of handling well among step B, C, the D, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, filling: with subsequent use granule and 1g micropowder silica gel mix homogeneously, filled capsules promptly gets medicament composition capsule agent of the present invention.
Embodiment two: the preparation of pharmaceutical composition tablet of the present invention
Fructus Alpiniae Oxyphyllae 40g Fructus Jujubae 40g soybean phospholipid 28g
Fish oil 8g taurine 8g
Preparation of pharmaceutical compositions method of the present invention comprises the steps:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 6 times of weight water distillation 3.5 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 9 times of weight decoctings and boil 2 times, and each 0.5 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
The processing of B, fish oil: get 12g starch and 7g micropowder silica gel, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 25g starch mix homogeneously, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is subsequent use;
E, with the fish oil of handling well among step B, C, the D, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, with the micropowder silica gel mix homogeneously of subsequent use granule and 1.5g, add conventional adjuvant, according to common process, process tablet.
Embodiment three: the preparation of medicament composition granule agent of the present invention
Fructus Alpiniae Oxyphyllae 70g Fructus Jujubae 15g soybean phospholipid 18g
Fish oil 12g taurine 8g
Preparation of pharmaceutical compositions method of the present invention comprises the steps:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
The processing of B, fish oil: get 20g starch and 8g micropowder silica gel, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 20g starch mix homogeneously, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is subsequent use;
E, with the fish oil of handling well among step B, C, the D, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, with subsequent use granule and 1g micropowder silica gel mix homogeneously, add conventional adjuvant, according to common process, process granule.
Embodiment four: the preparation of pharmaceutical composition pill of the present invention
Fructus Alpiniae Oxyphyllae 50g Fructus Jujubae 30g soybean phospholipid 15g
Fish oil 10g taurine 5g
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
B, get formula ratio soybean phospholipid, taurine, starch, 7.5g micropowder silica gel and mix, pulverize, cross 80 mesh sieves, put the one-step palletizing motor spindle, spray into above-mentioned extractum, drying, granule is subsequent use;
C, get formula ratio fish oil and add conventional adjuvant, be prepared into Powdered fish oil, subsequent use;
D, adding fish oil powder and 7.5g micropowder silica gel in above-mentioned granule, mixing adds conventional adjuvant, processes pill according to common process.
Embodiment five: the preparation of drug composition oral liquid of the present invention
Fructus Alpiniae Oxyphyllae 50g Fructus Jujubae 30g soybean phospholipid 15g
Fish oil 10g taurine 5g
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
B, get formula ratio soybean phospholipid, taurine, fish oil and above-mentioned extractum, add conventional adjuvant, process oral liquid according to common process.
Embodiment six: the preparation of drug combination injection of the present invention
Fructus Alpiniae Oxyphyllae 70g Fructus Jujubae 15g soybean phospholipid 18g
Fish oil 12g taurine 8g
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
B, get formula ratio soybean phospholipid, taurine, fish oil and above-mentioned extractum, add conventional adjuvant, process injection according to common process.
Embodiment seven: the preparation of medicament composition capsule agent of the present invention
Fructus Alpiniae Oxyphyllae 40g Fructus Jujubae 40g soybean phospholipid 28g
Fish oil 8g taurine 8g
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
B, soybean phospholipid, taurine, starch and 7.5g micropowder silica gel mix, and pulverize, and cross 80 mesh sieves, put the one-step palletizing motor spindle, spray into above-mentioned extractum, drying, and granule is subsequent use;
C, get formula ratio fish oil and add conventional adjuvant, be prepared into Powdered fish oil, subsequent use;
D, adding fish oil powder and 1.5g micropowder silica gel in above-mentioned granule, mixing is filled, and adds conventional adjuvant, processes capsule according to common process.
Claims (10)
1. one kind has the pharmaceutical composition that improves and improve memory, it is characterized in that the crude drug of this pharmaceutical composition consists of:
Fructus Alpiniae Oxyphyllae 30-80 weight portion Fructus Jujubae 10-50 weight portion soybean phospholipid 5-30 weight portion
Fish oil 5-15 weight portion taurine 2-10 weight portion.
2. a kind of pharmaceutical composition that improves and improve memory that has as claimed in claim 1 is characterized in that the crude drug of this pharmaceutical composition consists of:
Fructus Alpiniae Oxyphyllae 50 weight portion Fructus Jujubaes 30 weight portion soybean phospholipids 15 weight portions
Fish oil 10 weight portion taurines 5 weight portions.
3. a kind of pharmaceutical composition that improves and improve memory that has as claimed in claim 1 is characterized in that the crude drug of this pharmaceutical composition consists of:
Fructus Alpiniae Oxyphyllae 40 weight portion Fructus Jujubaes 40 weight portion soybean phospholipids 28 weight portions
Fish oil 8 weight portion taurines 8 weight portions.
4. a kind of pharmaceutical composition that improves and improve memory that has as claimed in claim 1 is characterized in that the crude drug of this pharmaceutical composition consists of:
Fructus Alpiniae Oxyphyllae 70 weight portion Fructus Jujubaes 15 weight portion soybean phospholipids 18 weight portions
Fish oil 12 weight portion taurines 8 weight portions.
5. like the arbitrary described pharmaceutical composition of claim 1-4, it is characterized in that getting crude drug, add conventional adjuvant, process capsule, granule, tablet, pill, oral liquid or injection according to common process.
6. like the arbitrary described preparation of drug combination method of claim 1-4, it is characterized in that this preparation of drug combination method comprises the steps:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 6-10 times of weight water distillation 2-4 hour, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 6-10 times of weight decocting and boil 1-3 time, and each 0.5-1.5 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
B, get 6 ~ 48 weight portion starch and 1 ~ 9 weight portion micropowder silica gel, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use;
The processing of C, soybean phospholipid: with the starch mix homogeneously of formula ratio soybean phospholipid and 10 ~ 50 weight portions, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: the formula ratio taurine is pulverized, crossed 80 mesh sieves, subsequent use;
E, with the fish oil of handling well among step B, C, the D, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, with subsequent use granule, add 0.2 ~ 3 parts by weight of micro silica gel powder mix homogeneously, add conventional adjuvant, process capsule, granule, tablet, pill, oral liquid or injection according to common process.
7. preparation of drug combination method as claimed in claim 6 is characterized in that this preparation of drug combination method comprises the steps:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
The processing of B, fish oil: get 20 weight portion starch, 5 weight portion micropowder silica gels, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use;
The processing of C, soybean phospholipid: with the formula ratio soybean phospholipid, add 20 weight portion starch mix homogeneously, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: the formula ratio taurine is pulverized, crossed 80 mesh sieves, subsequent use;
E, with the fish oil of handling well among step B, C, the D, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, with subsequent use granule and 1 parts by weight of micro silica gel powder mix homogeneously, add conventional adjuvant, process capsule, granule, tablet, pill, oral liquid or injection according to common process.
8. preparation of drug combination method as claimed in claim 6 is characterized in that this preparation of drug combination method comprises the steps:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 6 times of weight water distillation 3.5 hours, collect volatile oil, subsequent use behind the extracting liquid filtering; Medicinal residues and Fructus Jujubae add 9 times of weight decoctings and boil 2 times, and each 0.5 hour, to filter, filtrating merges with the Fructus Alpiniae Oxyphyllae extracting solution, under 60 ± 5 ℃, is evaporated to relative density and is 1.16～1.18 extractum, and is subsequent use;
The processing of B, fish oil: get 12 weight portion starch and 7 parts by weight of micro silica gel powder, mixing adds formula ratio fish oil then, and mixing is crossed 80 mesh sieves, and is subsequent use;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 25 weight portion starch mix homogeneously, cross 80 mesh sieves, subsequent use;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is subsequent use;
E, with the fish oil of handling well among step B, C, the D, soybean phospholipid and taurine mix homogeneously, place the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, subsequent use;
F, with subsequent use granule and 1.5 parts by weight of micro silica gel powder mix homogeneously, add conventional adjuvant, process capsule, granule, tablet, pill, oral liquid or injection according to common process.
9. preparation of drug combination method as claimed in claim 6 is characterized in that fish oil adds conventional adjuvant in this preparation of drug combination method, is prepared into Powdered fish oil.
10. has the application in the medicine that improves and improve memory like the described pharmaceutical composition of claim 1-5 in preparation.
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| CN106063540A (en) * | 2016-06-24 | 2016-11-02 | 湖北丽生堂生物科技有限公司 | A kind of beverage improving memory function and preparation method thereof |
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| CN1939439A (en) * | 2006-09-29 | 2007-04-04 | 李志民 | Juglone and jujube capsules with memory-improving function and preparation thereof |
| KR100832675B1 (en) * | 2006-09-22 | 2008-05-26 | 한상왕 | Nutritive supplement |
| CN101485445A (en) * | 2009-02-23 | 2009-07-22 | 梁德昌 | Health care food |
| CN101849990A (en) * | 2009-03-31 | 2010-10-06 | 北京因科瑞斯医药科技有限公司 | Pharmaceutical composition with function of improving memory and preparation method thereof |
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| WO2001041732A1 (en) * | 1999-12-06 | 2001-06-14 | Gore Stanley L | Compositions and methods for intranasal delivery of active agents to the brain |
| KR100832675B1 (en) * | 2006-09-22 | 2008-05-26 | 한상왕 | Nutritive supplement |
| CN1939439A (en) * | 2006-09-29 | 2007-04-04 | 李志民 | Juglone and jujube capsules with memory-improving function and preparation thereof |
| CN101485445A (en) * | 2009-02-23 | 2009-07-22 | 梁德昌 | Health care food |
| CN101849990A (en) * | 2009-03-31 | 2010-10-06 | 北京因科瑞斯医药科技有限公司 | Pharmaceutical composition with function of improving memory and preparation method thereof |
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| CN106063540A (en) * | 2016-06-24 | 2016-11-02 | 湖北丽生堂生物科技有限公司 | A kind of beverage improving memory function and preparation method thereof |
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