CN102652815B - 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 have raising and improve pharmaceutical composition of memory function and its production and use.
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 due to permanent or temporary dysmnesia Pathophysiology or that reason situation causes.Hypomnesis is a kind of dysmnesia, and is more common clinically, can show as going down of memory far away and nearly memory.Cause the reason of hypomnesis to have a variety of.Neurastheniac is noted not concentrating during often due to memorize and is caused hypomnesis; The brain organic Disease be due to the brain cell damage effect memory keep-process cause hypomnesis; The mankind are in aging course, and various function reduction and physiologic derangement phenomenon appear in body, and learning and memory is accompanied by the aging of body, also can fade; In addition, because the factors such as learning life cause spiritual high-pressure, or brain overwork makes neural fatigue also can cause hypomnesis continuously.
In recent years, due to the development of aged tendency of population, the increase of rhythm of life quickening and learning life pressure, the people of hypomnesis is more and more.Improving and improve memory, 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 modern medicine problems of concern.
Summary of the invention
The object of the invention is to disclose a kind of pharmaceutical composition, another purpose of the present invention is to disclose the preparation method of this pharmaceutical composition, the present invention also aims to disclose the purposes of this pharmaceutical composition.。
The present invention seeks to be achieved through the following technical solutions:
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 Jujubae 30 weight portion soybean phospholipid 15 weight portions
Fish oil 10 weight portion taurine 5 weight portions
Pharmaceutical composition crude drug composition of the present invention is preferably:
Fructus Alpiniae Oxyphyllae 40 weight portion Fructus Jujubae 40 weight portion soybean phospholipid 28 weight portions
Fish oil 8 weight portion taurine 8 weight portions
Pharmaceutical composition crude drug composition of the present invention is preferably:
Fructus Alpiniae Oxyphyllae 70 weight portion Fructus Jujubae 15 weight portion soybean phospholipid 18 weight portions
Fish oil 12 weight portion taurine 8 weight portions
Get the above-mentioned raw materials medicine, add conventional adjuvant, make capsule, granule, tablet, pill, slow releasing preparation, oral liquid or injection according to common process.
The preparation method of pharmaceutical composition 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, standby after 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, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
B, get 6 ~ 48 weight portion starch and 1 ~ 9 weight portion micropowder silica gel, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, standby or get formula ratio fish oil and add conventional adjuvant, is prepared into Powdered fish oil, standby;
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, standby;
The processing of D, taurine: the formula ratio taurine is pulverized, crossed 80 mesh sieves, standby;
E, with fish oil or fish oil powder, soybean phospholipid and the taurine mix homogeneously handled well in step B, C, D, be placed in the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, standby;
F, with standby granule, add the micropowder silica gel mix homogeneously of 0.2 ~ 3 weight portion, add conventional adjuvant, make capsule, granule, tablet, pill, slow releasing preparation, oral liquid or injection according to common process.
The preparation method of pharmaceutical composition of the present invention is preferably as follows step:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, standby after extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
The processing of B, fish oil: get 20 weight portion starch, 5 weight portion micropowder silica gels, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, and is standby; Or get formula ratio fish oil and add conventional adjuvant, be prepared into Powdered fish oil, standby;
The processing of C, soybean phospholipid: with the formula ratio soybean phospholipid, add 20 weight portion starch mix homogeneously, cross 80 mesh sieves, standby;
The processing of D, taurine: the formula ratio taurine is pulverized, crossed 80 mesh sieves, standby;
E, with fish oil or fish oil powder, soybean phospholipid and the taurine mix homogeneously handled well in step B, C, D, be placed in the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, standby;
F, with the micropowder silica gel mix homogeneously of standby granule and 1 weight portion, add conventional adjuvant, make capsule, granule, tablet, pill, slow releasing preparation, oral liquid or injection according to common process.
The preparation method of pharmaceutical composition of the present invention can also be preferably as follows step:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 6 times of weight water distillation 3.5 hours, collect volatile oil, standby after 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, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
The processing of B, fish oil: get the micropowder silica gel of 12 weight portion starch and 7 weight portions, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, and is standby; Or get formula ratio fish oil and add conventional adjuvant, be prepared into Powdered fish oil, standby;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 25 weight portion starch mix homogeneously, cross 80 mesh sieves, standby;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is standby;
E, with fish oil or fish oil powder, soybean phospholipid and the taurine mix homogeneously handled well in step B, C, D, be placed in the one-step palletizing motor spindle, above-mentioned extractum is sprayed into, spray granulation, drying, with 20 mesh sieve granulate, standby;
F, with the micropowder silica gel mix homogeneously of standby granule and 1.5 weight portions, add conventional adjuvant, make 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.
The below's experiment and embodiment are used for further illustrating but being not limited to the present invention.
Experimental example one: Ergonomy experiment
1 material
1.1 sample: pharmaceutical composition of the present invention (embodiment 1 preparation) is 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: SPF level Kunming mouse, body weight 18-22g, female, 240, animal credit number: SYXK(Hubei Province are provided by Hubei Province's Experimental Animal Center) No. 2003-0014,24 ℃ 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 gavage mice of 0.2ml/10gBW, be made into respective concentration with distilled water, matched group gavage distilled water, the gavage capacity is identical with the animal subject group, and gavage is 30 days continuously
1.4 instrument: the diving tower instrument, keep away dark instrument, 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 dosage groups and a blank group at random, and each dosage treated animal is 10 every group.Gavage is carried out the diving tower training after 30 days continuously.Animal was put into the reaction chamber endoadaptation 3 minutes, passes to immediately 36 volts of alternating currents, record the number of times (errors number of animal) that in 3 minutes, every Mus is shocked by electricity, with this as school grade.Cyclical test after 24 hours, number of animals, the errors number in the incubation period of jumping off for the first time platform and 3 minutes that record is shocked by electricity.
2.2 keep away dark test:
Animal is selected, the test grouping, and dosage, approach, time is same step down test all.Continuously gavage begins to keep away dark training after 30 days, records every Mus and enters the darkroom and shocked by electricity required time, i.e. incubation period from putting into bright chamber.The errors number in incubation period, 5 minutes of every Mus and the number of animals that enters the darkroom are recorded in cyclical test after 24 hours.
2.3 water maze test:
Animal is selected, the test grouping, and dosage, approach, time is same step down test all.Gavage begins training after 30 days continuously, 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 ladder for the first time, it is climbed up 3 times automatically, before each training, animal is placed near ladder later on, 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.When training for the first time, in the beginning of A place, training for the second time lengthens distance, begins from B, and this distance is approximately trained 3 times, trains altogether 4 times, reaches home to 80% above animal.Last is trained from starting point, records 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 processed.
3 results
3.1 the impact on Mouse Weight:
The impact of table 1 pharmaceutical composition of the present invention on Mouse Weight---active experiment (water maze test)
The impact of table 2 pharmaceutical composition of the present invention on Mouse Weight---by dynamic test (step down test)
The impact of table 3 pharmaceutical composition of the present invention on Mouse Weight---by dynamic test (keeping away dark test)
By table 1, table 2, as seen from Table 3, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, active experiment (water maze test) and by each dosage treated animal body weight of dynamic test (step down test and keep away dark test) and matched group comparison, there are no significant for difference (P＞0.05).
3.2 impact---the water maze test on the mouse memory acquisition:
Impact---the water maze test that table 4 pharmaceutical composition of the present invention obtains mouse memory
By as seen from Table 4, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, and the time that each dosage group mice of active experiment (water maze test) is reached home and errors number are all less than matched group, wherein, middle and high dosage group and matched group compare, and difference all has significance (P＜0.05, P＜0.05).The number of animals of reaching home in 2min and matched group relatively, each dosage group all has growth, but difference there are no significant (P＞0.05).
3.3 the impact on the mouse memory acquisition---keep away dark test:
Table 5 pharmaceutical composition of the present invention is kept away the preclinical impact of dark test to mice
By as seen from Table 5, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in keeping away dark test, during each dosage group training of mice, incubation period and matched group compare, and there are no significant for difference (P＞0.05), tests incubation period after 24 hours, each dosage group 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 impact of dark experimental mistake number of times on mice
By as seen from Table 6, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in keeping away dark test, during each dosage group training of mice, average error number of times and matched group compare, and there are no significant for difference (P＞0.05), test average error number of times after 24 hours, each dosage group 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 impact of dark experimental mistake response rate on mice
By as seen from Table 7, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in keeping away dark test, during each dosage group training of mice, wrong reaction rate and matched group are relatively, there are no significant for difference (P＞0.05), test wrong reaction rate after 24 hours, each dosage group is all less than matched group, and there are no significant for difference (P＞0.05).
3.4 impact---the step down test on the mouse memory acquisition:
Table 8 pharmaceutical composition of the present invention is on the preclinical impact of mice step down test
By as seen from Table 8, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in step down test, during each dosage group training of mice, incubation period and matched group are relatively, there are no significant for difference (P＞0.05), tests incubation period after 24 hours, and each dosage group all is longer than matched group incubation period.Wherein, middle and high dosage group and matched group compare, and difference has significance (P＜0.05, P＜0.05).
The impact of table 9 pharmaceutical composition of the present invention on mice step down test errors number
By as seen from Table 9, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in step down test, and average error number of times and matched group comparison during each dosage group training of mice, there are no significant for difference (P＞0.05).Test average error number of times after 24 hours, each dosage group is all less than matched group, and wherein, high dose group and matched group compare, and difference has significance (P＜0.05).
The impact of table 10 pharmaceutical composition of the present invention on mice step down test wrong reaction rate
By as seen from Table 10, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in step down test, and test wrong reaction rate and matched group comparison during each dosage group training of mice and after 24 hours, 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 re-started once.
The impact of table 11 pharmaceutical composition of the present invention on Mouse Weight---water maze (repetition) test
The impact of table 12 pharmaceutical composition of the present invention on Mouse Weight---diving tower (repetition) test
The impact of table 13 pharmaceutical composition of the present invention on Mouse Weight---keep away dark (repetition) test
By table 11, table 12, as seen from Table 13, the continuous gavage of pharmaceutical composition 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 dosage treated animal body weight and matched group comparison, and there are no significant for difference (P＞0.05).
The impact that table 14 pharmaceutical composition of the present invention obtains mouse memory---water maze (repetition) test
By as seen from Table 14, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, and water maze (repetition) is tested time that each dosage group mice reaches home and errors number all less than matched group, wherein, middle and high dosage group and matched group compare, and difference all has significance (P＜0.05, P＜0.05).The number of animals of reaching home in 2min and matched group relatively, each dosage group 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 impact
By as seen from Table 15, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in keeping away dark (repetition) test, during each dosage group training of mice, incubation period and matched group compare, and there are no significant for difference (P＞0.05), tests incubation period after 24 hours, each dosage group 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 impact of (repetition) dark experimental mistake number of times on mice
By as seen from Table 16, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in keeping away dark (repetition) test, during each dosage group training of mice, average error number of times and matched group compare, and there are no significant for difference (P＞0.05), test average error number of times after 24 hours, each dosage group 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 impact of secretly (repetition) experimental mistake response rate on mice
By as seen from Table 17, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in keeping away (repetition) dark test, during each dosage group training of mice, wrong reaction rate and matched group are relatively, there are no significant for difference (P＞0.05), test wrong reaction rate after 24 hours, each dosage group is all less than matched group, and there are no significant for difference (P＞0.05).
Table 18 pharmaceutical composition of the present invention on the mice diving tower (repetition) test preclinical impact
By as seen from Table 18, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in diving tower (repetition) test, during each dosage group training of mice, incubation period and matched group compare, and there are no significant for difference (P＞0.05), tests incubation period after 24 hours, each dosage group 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.
The impact of table 19 pharmaceutical composition of the present invention on mice diving tower (repetition) experimental mistake number of times
By as seen from Table 19, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in diving tower (repetition) test, and average error number of times and matched group comparison during each dosage group training of mice, there are no significant for difference (P＞0.05).Test average error number of times after 24 hours, each dosage group is all less than matched group, and wherein, high dose group and matched group compare, and difference has significance (P＜0.05).
The impact of table 20 pharmaceutical composition of the present invention on mice diving tower (repetition) experimental mistake response rate
By as seen from Table 20, the continuous gavage of pharmaceutical composition of the present invention is after 30 days, in diving tower (repetition) test, and test wrong reaction rate and matched group comparison during each dosage group training of mice and after 24 hours, 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 gavage SPF level Kunming mouse of 0.2ml/10gBW, be made into respective concentration with distilled water, matched group gavage distilled water, the gavage capacity is identical with the animal subject group, and gavage is 30 days continuously.Result shows:
(1) each dosage group compares impact and the matched group of Mouse Weight, and there are no significant for difference (P＞0.05);
(2) in water maze test, time and errors number that middle and high dosage group 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 energy of each dosage group 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 dosage group 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 energy of each dosage group 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 dosage group 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 the effect that improves and improve memory to SPF level Kunming mouse.
Experimental example two: clinical experimental study
1 materials and methods
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 the memory pointed to and learning by association and tape, picture material (minute 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.The subjects schooling is basically identical, does not accept similar test, does not take in a short time medicine or the health food relevant with this product function.
1.4 test grouping and usage and dosage: double-blind method is adopted in this test, the experimenter is divided into 2 groups at random, gets rid of and ends for some reason the experimenter midway, 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 status 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.Looked into scale score in original minute with each subtest after test, each subtest scale score addition gets total scale score, looks into memory quotient according to total scale score.The effect index is as follows
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 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 satisfy normal state or variance neat after, carry out t with the data of conversion and check; 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 large (as CV＞50%) is used rank test.
2.4 result is judged: before test under the prerequisite of two groups of memory quotient equilibriums, after test, the memory quotient of test group is higher than matched group, and difference has significance, memory quotient after test group test simultaneously is higher than the front memory quotient of test, and difference has significance, can judge that sample has the effect that improves memory.
3. result
3.1 physical data: after test, the situations such as test group spirit, sleep, diet all have certain improvement, compare no significant difference with matched group.
3.2 safety indexes observed result
Hemogram and liver, renal function change (X ± SD) before and after table 21 test-meal
Stool, urine 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 test, * P＜0.05
The comparison of memory quotient before and after table 25 test (X ± SD)
Compare * * P＜0.01 before and after test, compare ##P＜0.01 between test group,
3. brief summary
Select 110 high school students, random, double-blind trial method is divided into test group and matched group, actually enters 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: test front two groups of memory quotient balanced; 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 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 test, each safety indexes does not all produce ANOMALOUS VARIATIONS, does not observe untoward reaction.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
Pharmaceutical composition preparation 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, standby after extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
The processing of B, fish oil: get 20g starch and 5g micropowder silica gel, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, and is standby;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 20g starch mix homogeneously, cross 80 mesh sieves, standby;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is standby;
E, the fish oil with handling well in step B, C, D, soybean phospholipid and taurine mix homogeneously are placed in the one-step palletizing motor spindle, above-mentioned extractum sprayed into, and spray granulation, drying, with 20 mesh sieve granulate, standby;
F, filling: with standby granule and 1g micropowder silica gel mix homogeneously, filled capsules namely gets medicament composition capsule agent of the present invention.
Embodiment two: the preparation of medicinal composition tablets of the present invention
Fructus Alpiniae Oxyphyllae 40g Fructus Jujubae 40g soybean phospholipid 28g
Fish oil 8g taurine 8g
Pharmaceutical composition preparation 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, standby after 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, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
The processing of B, fish oil: get 12g starch and 7g micropowder silica gel, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, and is standby;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 25g starch mix homogeneously, cross 80 mesh sieves, standby;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is standby;
E, the fish oil with handling well in step B, C, D, soybean phospholipid and taurine mix homogeneously are placed in the one-step palletizing motor spindle, above-mentioned extractum sprayed into, and spray granulation, drying, with 20 mesh sieve granulate, standby;
F, with the micropowder silica gel mix homogeneously of standby granule and 1.5g, add conventional adjuvant, according to common process, make 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
Pharmaceutical composition preparation 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, standby after extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
The processing of B, fish oil: get 20g starch and 8g micropowder silica gel, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, and is standby;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 20g starch mix homogeneously, cross 80 mesh sieves, standby;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is standby;
E, the fish oil with handling well in step B, C, D, soybean phospholipid and taurine mix homogeneously are placed in the one-step palletizing motor spindle, above-mentioned extractum sprayed into, and spray granulation, drying, with 20 mesh sieve granulate, standby;
F, with standby granule and 1g micropowder silica gel mix homogeneously, add conventional adjuvant, according to common process, the granulation agent.
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, standby after extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
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 standby;
C, get formula ratio fish oil and add conventional adjuvant, be prepared into Powdered fish oil, standby;
D, add fish oil powder and 7.5g micropowder silica gel in above-mentioned granule, mixing adds conventional adjuvant, makes 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, standby after extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
B, get formula ratio soybean phospholipid, taurine, fish oil and above-mentioned extractum, add conventional adjuvant, make 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, standby after extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
B, get formula ratio soybean phospholipid, taurine, fish oil and above-mentioned extractum, add conventional adjuvant, make 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, standby after extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
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 standby;
C, get formula ratio fish oil and add conventional adjuvant, be prepared into Powdered fish oil, standby;
D, add in above-mentioned granule the fish oil powder and and the 1.5g micropowder silica gel, mixing is filled, and adds conventional adjuvant, makes capsule according to common process.
Claims (7)
1. one kind has the preparation method that improves and improve the pharmaceutical composition of memory, it is characterized in that the preparation method of this pharmaceutical composition comprises the steps:
Get the crude drug of described pharmaceutical composition:
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;
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 6-10 times of weight water distillation 2-4 hour, collect volatile oil, standby after 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, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
B, get 6～48 weight portion starch and 1～9 weight portion micropowder silica gel, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, and is standby;
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, standby;
The processing of D, taurine: the formula ratio taurine is pulverized, crossed 80 mesh sieves, standby;
E, the fish oil with handling well in step B, C, D, soybean phospholipid and taurine mix homogeneously are placed in the one-step palletizing motor spindle, above-mentioned extractum sprayed into, and spray granulation, drying, with 20 mesh sieve granulate, standby;
F, with standby granule, add the micropowder silica gel mix homogeneously of 0.2～3 weight portion, add conventional adjuvant, make capsule, granule, tablet, pill, oral liquid or injection according to common process.
2. a kind of preparation method that improves and improve the pharmaceutical composition of memory that has as claimed in claim 1, is characterized in that the preparation method of this pharmaceutical composition comprises the steps:
A, extraction: get the formula ratio Fructus Alpiniae Oxyphyllae, add 8 times of weight water distillation 3 hours, collect volatile oil, standby after extracting liquid filtering; Medicinal residues and Fructus Jujubae add 8 times of weight decoctings and boil 2 times, and each 1 hour, to filter, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
The processing of B, fish oil: get 20 weight portion starch, 5 weight portion micropowder silica gels, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, and is standby;
The processing of C, soybean phospholipid: with the formula ratio soybean phospholipid, add 20 weight portion starch mix homogeneously, cross 80 mesh sieves, standby;
The processing of D, taurine: the formula ratio taurine is pulverized, crossed 80 mesh sieves, standby;
E, the fish oil with handling well in step B, C, D, soybean phospholipid and taurine mix homogeneously are placed in the one-step palletizing motor spindle, above-mentioned extractum sprayed into, and spray granulation, drying, with 20 mesh sieve granulate, standby;
F, with the micropowder silica gel mix homogeneously of standby granule and 1 weight portion, add conventional adjuvant, make capsule, granule, tablet, pill, oral liquid or injection according to common process.
3. a kind of preparation method that improves and improve the pharmaceutical composition of memory that has as claimed in claim 1, is characterized in that the preparation method of this pharmaceutical composition 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, standby after 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, filtrate and the merging of Fructus Alpiniae Oxyphyllae extracting solution under 60 ± 5 ℃, are evaporated to relative density and are 1.16～1.18 extractum, and is standby;
The processing of B, fish oil: get the micropowder silica gel of 12 weight portion starch and 7 weight portions, then mixing adds formula ratio fish oil, and mixing is crossed 80 mesh sieves, and is standby;
The processing of C, soybean phospholipid: with formula ratio soybean phospholipid and 25 weight portion starch mix homogeneously, cross 80 mesh sieves, standby;
The processing of D, taurine: taurine is pulverized, and crosses 80 mesh sieves, and is standby;
E, the fish oil with handling well in step B, C, D, soybean phospholipid and taurine mix homogeneously are placed in the one-step palletizing motor spindle, above-mentioned extractum sprayed into, and spray granulation, drying, with 20 mesh sieve granulate, standby;
F, with the micropowder silica gel mix homogeneously of standby granule and 1.5 weight portions, add conventional adjuvant, make capsule, granule, tablet, pill, oral liquid or injection according to common process.
4. described a kind of preparation method that improves and improve the pharmaceutical composition of memory that has as arbitrary in claim 1-3 is characterized in that the crude drug of described pharmaceutical composition consists of:
Fructus Alpiniae Oxyphyllae 50 weight portion Fructus Jujubae 30 weight portion soybean phospholipid 15 weight portions
Fish oil 10 weight portion taurine 5 weight portions.
5. described a kind of preparation method that improves and improve the pharmaceutical composition of memory that has as arbitrary in claim 1-3 is characterized in that the crude drug of described pharmaceutical composition consists of:
Fructus Alpiniae Oxyphyllae 40 weight portion Fructus Jujubae 40 weight portion soybean phospholipid 28 weight portions
Fish oil 8 weight portion taurine 8 weight portions.
6. described a kind of preparation method that improves and improve the pharmaceutical composition of memory that has as arbitrary in claim 1-3 is characterized in that the crude drug of described pharmaceutical composition consists of:
Fructus Alpiniae Oxyphyllae 70 weight portion Fructus Jujubae 15 weight portion soybean phospholipid 18 weight portions
Fish oil 12 weight portion taurine 8 weight portions.
7. a kind of preparation method that improves and improve the pharmaceutical composition of memory that has as claimed in claim 1 is characterized in that in the preparation method of this pharmaceutical composition, fish oil adds conventional adjuvant, is prepared into Powdered fish oil.
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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 |
| 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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| 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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| 无.康馨宝牌倍轻灵胶囊.《易达保健品网，http://www.1188bjp.com/news/newsDetail.php?id=8056》.2012,第1页第4行至第13行. * |
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