CN101143181B - Traditional Chinese medicinal composition for treating senile dementia and preparation method and application thereof - Google Patents
Traditional Chinese medicinal composition for treating senile dementia and preparation method and application thereof Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a combination of traditional Chinese medicine for remedying the senile dementia, which comprises the medicinal materials of a common cnidium fruit, a ginseng, a barbary wolfberry fruit, a glossy privet fruit etc. The invention also discloses the preparation method and purpose of the combination of traditional Chinese medicine.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of Chinese medicine composition for the treatment of alzheimer disease and its production and use.
Background technology
Alzheimer disease (Alzheimer disease, AD) be the neuropsychiatric disease of a kind of geratic period and presenium onset, with the latent loss of memory, aphasia, visual space technical ability infringement, abstract thinking and calculating infringement, personality and behavior change of attacking onset is the cerebral retrogressive type disease of feature, and part patient in a certain stage of morbidity depressive symptom and mental symptom can take place.
China has striden into the society of the aged, China over-65s alzheimer disease patient estimates to surpass 5,000,000 people, account for 1/4th of the total case load in the world, because the alzheimer disease patient need take medicine for a long time to delay disease process, the quality of making the life better, the developing target market of senile dementia treatment medicine has a extensive future.The traditional Chinese medical science is divided into following type substantially for the Therapeutic Method of alzheimer disease at present:
Control from kidney opinion: many doctors think that the basic cause of disease of disease is for suffering from a deficiency of the kidney, so based on the kidney invigorating, the compatibility other medicines are treated, traditional prescription such as Sancaifengsui medicinal pellet, Bolus as a Kidney-Yin-Tonic etc.Modern method of treatment has invigorating kidney, promoting blood circulation method, invigorating kidney, promoting blood circulation blood stasis dispersing and phlegm expelling method, kidney tonifying, essence replenishing benefit marrow method, the kidney invigorating brain-strengthening method etc. [Xu Hao, Ma Lingyun, from kidney opinion punish-old dementia progress [J], Chinese medicine journal 1996,24 (4): 59] of having one's ideas straightened out.
Control from the liver opinion: [Wu Zhengzhi, Zhang Shuifeng such as Wu Zhengzhi.The purging liver-fire method is in the shadow of memory of senile dementia model learning and maincenter monoamine neurotransmitter [J].China's TCM basis medical journal, 1998,4 (12): 25-28] with of the research of purging liver-fire method to the influence of memory of animal senile dementia model learning and maincenter monoamine neurotransmitter, the result shows: the purging liver-fire method can obviously be improved the learning memory disorder of animal pattern, improve NA and 5-HT level, especially 5-HT is had tangible regulating action.
Control from the expectorant opinion: Yue Jianping [Yue Jianping.Effect of Ditan Huayu Decoction is treated senile cerebrovascular dementia disease 20 examples [J].The Hubei Journal of Traditional Chinese Medicine, 1996,18 (3): 2818] intend clearing away phlegm and removing blood stasis collateral dredging soup certainly for square substantially: the Radix Astragali, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Semen Persicae, Pheretima, Radix Curcumae, Rhizoma Acori Graminei, Radix Polygalae, Rhizoma Gastrodiae, Scorpio, Scolopendra etc. are with card plus-minus treatment 20 these type of patients of example, produce effects 11 examples, effective 7 examples, invalid 2 examples.
Control from stasis of blood opinion: Yan Qianlin [face universe squama.Alzheimer disease is distinguished the cognition of controlling [J] from the stasis of blood.Journal of Traditional Chinese Medicine, 1995,36] treatment qi stagnation and blood stasis type madness awakening decoction; Qi deficiency blood stasis type is added and subtracted with the red SIWU TANG of yiqi clever soup walnut; Expectorant stasis of blood interlocking type closes sensible Tonga with the Rhizoma Coptidis WEIDANTANG and subtracts; The empty blood stasis type of marrow is with intending brain-care soup certainly.
Still the specific drug that does not have the treatment alzheimer disease at present both at home and abroad, compound Chinese medicinal preparation are blank especially.No matter the compound of Chinese medicine alzheimer disease is on curative effect or certain advantage is all being arranged aspect the expense expenditure.Inventor's process studies for a long period of time, and by the clinical trial checking, has found the oral medicinal herb medicine of better healing alzheimer disease finally, thereby finished the present invention.
Summary of the invention
The object of the invention is to provide a kind of Chinese medicine composition of more efficiently treatment alzheimer disease.
Another purpose of the present invention has been to provide the preparation method of this Chinese medicine composition.
Another object of the present invention has been to provide the purposes of this traditional Chinese medicine composition for treating alzheimer disease.
The Chinese medicine composition of a kind of the kidney invigorating Fructus Alpiniae Oxyphyllae of the present invention is made of following component by weight ratio:
50～250 parts of Fructus Cnidiis, 50～250 parts of Radix Ginsengs, 50～150 parts of Fructus Lycii, 50～150 parts of Fructus Ligustri Lucidi, 50～150 parts of Radix Polygoni Multiflori Preparatas, 50～150 parts of Cortex Moutans, 0.1～5 part of Borneolum Syntheticum.
The weight proportion of described each component is preferably:
100～200 parts of Fructus Cnidiis, 100～200 parts of Radix Ginsengs, 75～125 parts of Fructus Lycii, 75～125 parts of Fructus Ligustri Lucidi, 75～125 parts of Radix Polygoni Multiflori Preparatas, 75～125 parts of Cortex Moutans, 0.5～2 part of Borneolum Syntheticum.
The weight optimum ratio of described each component is:
150 parts of Fructus Cnidiis, 150 parts of Radix Ginsengs, 100 parts of Fructus Lycii, 100 parts of Fructus Ligustri Lucidi, 100 parts of Radix Polygoni Multiflori Preparatas, 100 parts of Cortex Moutans, 1 part of Borneolum Syntheticum;
Another optimum ratio of described each composition weight is:
148.8 parts of Fructus Cnidiis, 148.8 parts of Radix Ginsengs, 99.3 parts of Fructus Lycii, 99.3 parts of Fructus Ligustri Lucidi, 99.3 parts of Radix Polygoni Multiflori Preparatas, 99.3 parts of Cortex Moutans, 1 part of Borneolum Syntheticum.
According to the method for traditional Chinese medicine, pharmaceutical composition of the present invention can be made decoction and directly take, also can be processed into extract and make any preparation on the pharmaceutics with suitable adjuvant through extraction.As tablet, capsule, granule, injection, injectable powder, transfusion, drop pill.Be preferably capsule.
For the ease of making preparation, the medical material of respectively distinguishing the flavor of in the pharmaceutical composition of the present invention both can extract separately also and can combination in any extract, and did not influence the therapeutic effect of this pharmaceutical composition.
Particularly, the present invention also provides a kind of preparation method of above-mentioned composition, and this method comprises the following steps:
A. by weight ratio, get following raw material ready: 50～250 parts of Fructus Cnidiis, 50～250 parts of Radix Ginsengs, 50～150 parts of Fructus Lycii, 50～150 parts of Fructus Ligustri Lucidi, 50～150 parts of Radix Polygoni Multiflori Preparatas, 50～150 parts of Cortex Moutans, 0.1～5 part of Borneolum Syntheticum;
B. get the Cortex Moutan vapor distillation, get paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and concentrates, and the alcohol precipitation filters, and filtrate decompression is condensed into extractum, and is standby;
C. get Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata alcohol reflux, filter, merging filtrate reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is standby;
D. get the Fructus Lycii extracting in water, filter, collecting decoction concentrates, and adds chitosan-acetic acid solution, insulation is placed, and filters, and the polyamide or the macroporous resin column of anticipating on the filtrate are separated, wash with water to effluent closely colourlessly earlier, merge, concentrate standby by liquid and water lotion; The reuse ethanol elution is collected eluent, reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is standby; The cation exchange resin column of having handled well on the above-mentioned concentrated solution washes with water to effluent closely colourlessly earlier, and reuse ammonia spirit eluting is collected eluent, and concentrating under reduced pressure becomes extractum;
E. merge with above-mentioned extractum, add paeonol, Borneolum Syntheticum fine powder, mixing is made preparation.
Wherein, preserve down in 3-5 ℃ Cortex Moutan distillation back among the step b, the dry paeonol that gets of sucking filtration thing, and being concentrated into relative density is 1.05～1.10 (60 ℃ of surveys), add ethanol to containing alcohol amount 50%-70%, filtrate is concentrated into 1.20-1.40 (60 ℃ of surveys), is preferably, and preserve down in 4 ℃ Cortex Moutan distillation back, the dry paeonol that gets of sucking filtration thing, being concentrated into relative density is 1.08 (60 ℃ of surveys), adds ethanol to containing alcohol amount 60%, and filtrate is concentrated into 1.30 (60 ℃ of surveys).
Among the step c, the concentration of Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata alcohol reflux is 70%-90%, extract 1-3 time, reclaiming ethanol, to be concentrated into relative density be 1.20-1.40 (60 ℃ of surveys), is preferably to use 80% alcohol reflux 2 times 6 times of the dose of making a living for the first time, extracted 1.5 hours, make a living for the second time 5 times of dose extracted 1.0 hours, and it is 1.30 (60 ℃ of surveys) that recovery ethanol is concentrated into relative density.
In the steps d, Fructus Lycii water extraction 1-3 time, collecting decoction is concentrated into 1: 0.3-0.5,40-60 ℃ adds the 0.5-1.5% chitosan-acetic acid solution, be incubated 0.4-1 hour, the polyamide or the macroporous resin column of anticipating on the filtrate are separated, and merge by liquid and water lotion behind the eluting, are concentrated into 1: 0.5-1.5, the ethanol elution of reuse 70%-80%, collect eluent, reclaim ethanol, concentrating under reduced pressure becomes the extractum of 1.20-1.40 (60 ℃ of surveys), the 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution, with 3-7% ammonia spirit eluting, collect eluent, concentrating under reduced pressure becomes the extractum of 1.20-1.40 (60 ℃ of surveys);
Preferred extraction process is that Fructus Lycii decocts with water 2 times, 6 times for the first time, 5 times for the second time, decocted 1.0 hours at every turn, filter, collecting decoction is concentrated into 1: 0.4, and 50 ℃ add 1% chitosan-acetic acid solution, is incubated 0.5 hour, place, filter, polyamide of anticipating on the filtrate or D101 macroporous resin column are separated, wash with water to effluent closely colourless earlier, merge by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys).
Among the step e, preferably adopt following method to make capsule: add micropowder silica gel, vacuum drying adds paeonol and Borneolum Syntheticum, incapsulates.
The preferred for preparation method of the Chinese medicine composition of a kind of the kidney invigorating Fructus Alpiniae Oxyphyllae of the present invention is taked following steps:
A. by weight ratio, get following raw material ready: 50～250 parts of Fructus Cnidiis, 50～250 parts of Radix Ginsengs, 50～150 parts of Fructus Lycii, 50～150 parts of Fructus Ligustri Lucidi, 50～150 parts of Radix Polygoni Multiflori Preparatas, 50～150 parts of Cortex Moutans, 0.1～5 part of Borneolum Syntheticum;
B. get the Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying gets paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby, the medicinal liquid after the distillation filters, being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. get Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata with 80% alcohol reflux 2 times, 6 times for the first time, extracted 5 times of the second time 1.5 hours, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. get Fructus Lycii and decoct with water secondary, 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, polyamide of anticipating on the filtrate or D101 macroporous resin column wash with water to effluent closely colourlessly earlier, merge by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add paeonol, Borneolum Syntheticum fine powder, mixing is made preparation.
In order to guarantee therapeutic effect, which kind of preparation no matter pharmaceutical composition of the present invention make, and the medicine of taking its every day is calculated as 30g～40g according to the crude drug amount, is preferably 35.05g.Medicining times is decided on the state of an illness and preparation type, general every day 2-3 time.
Pharmaceutical composition of the present invention is made up of Fructus Cnidii, Fructus Lycii, Fructus Ligustri Lucidi, Radix Ginseng, the Radix Polygoni Multiflori, Cortex Moutan, Borneolum Syntheticum.Be monarch drug with Fructus Cnidii, Fructus Lycii, Fructus Ligustri Lucidi in the side, flat tonifying kidney-yin kidney yang, benefiting essence and marrow; Radix Ginseng, the Radix Polygoni Multiflori are ministerial drug, benefiting QI and nourishing blood; Assistant is with the Cortex Moutan removing heat from blood and promoting blood circulation, and it is hot and suffocating in purifying the blood that eliminating blood stasis and smoothing collaterals is double; The Borneolum Syntheticum refreshment of having one's ideas straightened out, and the characteristic of borrowing its fragrance to go on guide many medicines to go directly in the brain mansion, altogether department's merit of refreshment of having one's ideas straightened out.This side takes into account the deficiency of elderly patients' QI and blood based on flat tonifying kidney-yin kidney yang, blood circulation and channel invigorating, and the refreshment of having one's ideas straightened out effectively at the etiology and pathogenesis of alzheimer disease, must fill patient's brains, and QI and blood must be mended, and the stasis of blood stagnates to such an extent that disappear, and clear key must be opened, and gods are personal.
Below by to clinical observation, further specify beneficial effect of the present invention.
(call in the following text: for estimating pharmaceutical composition of the present invention the kidney invigorating Fructus Alpiniae Oxyphyllae side) at memory that improves patient AD and cognitive function, or delay the effect of patient's aspects such as cognitive disorder, adopt multicenter, randomized controlled test method, carried out 141 routine the kidney invigorating Fructus Alpiniae Oxyphyllae sides treatment alzheimer disease patient clinical research year October in JIUYUE, 1998 to 2000.Case derives from No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ (Guangdong Provincial TCM Hospital), Guangzhou nursing homes, Tongji Hospital, Tongji Medical Univ, The People's Hospital, second Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi.Comprehensive therapeutic effect is the result show, the kidney invigorating Fructus Alpiniae Oxyphyllae side obvious effective rate is 61.9%, and effective percentage is 9.5%, and coefficient of stabilization is 15.9%, and progression rates is 12.7%, compares with matched group to have statistical significance.
One, case diagnosis standard: adopt that Americanism disease association works out about AD standard [American PsychiathricAssociation:Dementia, in Diagnostic and Statistical Manual-f Mental Disorders Fourth Edition, DSM-IV; P133-143,1994] and the state-run nerve of the U.S. and language disease and apoplexy study AD diagnostic criteria [the Guy Mckhann of dull-witted and relevant disease association (NINCDS-ADRDA) formulation of U.S. in one's power, David Drachman, Marshall Fdstein, et al.Clinical Diagnisis ofAlzheimer ' s disease:Report ofthe NINCDS-ADRDA Work Group under the Auspices ofDepartment ofHealth and Human Services Task Force onAlzheimer ' s Disease.Neurology; 1984; 34:839-44].
Two, EXPERIMENTAL DESIGN: adopt multicenter, at random, double blinding, controlled trial
Three, test medication:
Investigational agent: the kidney invigorating Fructus Alpiniae Oxyphyllae side capsule (adopt embodiment 1 in method preparation), each 3g, every day secondary, three months courses of treatment.
The contrast medicine: huperzine A sheet (huperzine A) 0.15mg/ time, every day secondary, three months courses of treatment.
The double blinding medicine is prepared: test group: the kidney invigorating Fructus Alpiniae Oxyphyllae side capsule+placebo (simulation huperzine A)+placebo tablet (redness)
Matched group: huperzine A+placebo (simulation the kidney invigorating Fructus Alpiniae Oxyphyllae side granule)+placebo tablet (redness)
Four, observation item: MMSE, ADL, FAQ, Hachinski ischemia index, neuropsychological test, neurologic check, health check-up, CT, lab index etc.
Five, efficacy determination:
1. comprehensive therapeutic effect is judged
MMSE (brief mental status scale) total points, FAQ (social activity function) total points, ADL (activity of daily living) total points, draw clock (CDT), FOM (object memory test) total points, RVR (test of vocabulary fluency) total points, DST (numerical span test) total points, BNT (Boston names test) total points totally 8 carry out the comprehensive therapeutic effect judgement.
With reference to CGIC (Clinical Global Impression of Change, Guy 1976) classification, curative effect is divided into seven grades:
I (extremely significantly improve): the summation increase that 8 effect indexes are kept the score after the markization is equal to or greater than 25%
II (significantly improve): 8 effect indexes summation increase 15-24% after the markization that keeps the score
III (slight improve): 8 effect indexes summation increase 5-14% after the markization that keeps the score
IV (no change): the summation that 8 effect indexes are kept the score after the markization increases or reduces less than 5%
V (slight worsen): 8 effect indexes summation minimizing 5-14% after the markization that keeps the score
VI (significantly worsen): 8 effect indexes summation minimizing 15-24% after the markization that keeps the score
VII (extremely significantly worsen): the summation minimizing that 8 effect indexes are kept the score after the markization is equal to or greater than 25%
* " increase ": be meant to help the variation of keeping the score that disease takes a turn for the better
" minimizing ": be meant the variation of keeping the score that is unfavorable for that disease takes a turn for the better
The mark method of * index: to MMSE, FAQ, ADL, picture clock, FOM, RVR, DST, BNT, marking.Belonging in the other direction, project is that FAQ, ADL, picture clock are done the direction adjustment when the score markization.
Above-mentioned seven grades are reduced: produce effects: I+II; Effectively: III; Stable: IV; Progress: V+VI+VII
2. compare between the group of difference before and after each single index score value treatment
Six, result
1. two groups of preceding baseline characteristic analyses of treatment
Two groups of sexes, age, education degree, the course of disease, dementia severity, MMSE total points, FAQ total points, ADL total points, picture clock, FOM total points, RVR total points, DST total points, BNT total points compare, difference there are no significant meaning (being P＞0.10) shows that two groups have better comparability.
2. two groups of efficacy analysis
Treat back eight main effects indexs for (1) two group
*Comprehensive therapeutic effect
*Relatively (meet program analysis, Per-Protocol SubjectsAnalyses, PPA)
Table 1. liang back eight the main effects index comprehensive curative effects of group treatment relatively
Rank test (Mann-Whitney) z=1.113 P=0.266
*Eight main effects indexs are pointed out and are known and daily routines, social function etc.: comprise MMSE total points, FAQ total points, ADL total points, draw clock, totally eight of FOM total points, RVR total points, DST total points, BNT total points.
*Comprehensive therapeutic effect is with reference to CGIC (Clinical Global Impression of Change, Guy 1976) classification.
Comprehensive therapeutic effect is the result show, the kidney invigorating Fructus Alpiniae Oxyphyllae side obvious effective rate is 61.9%, and effective percentage is 9.5%, and coefficient of stabilization is 15.9%, and progression rates is 12.7%; Huperzine A (huperzine A) obvious effective rate is 50.0%, and effective percentage is 18.2%, and coefficient of stabilization is 12.1%, and progression rates is 19.7%.Two groups relatively, the difference not statistically significant.
Total points comparison after (2) two groups eight the main effects index markizations (meet program analysis, Per-Protocol Subjects Analyses, PPA)
Eight main effects index markization backs of table 2. liang group total points is (before difference=treatment back-treatment) relatively
*
z 0.801
Rank test between group
P 0.423
*Eight main effects indexs refer to: MMSE, FAQ, ADL, picture clock, FOM, RVR, DST, BNT.Data are sum after the markization before treating in the table, after the treatment.
Relatively, difference has the significance meaning before and after the total points treatment of eight main effects indexs of treatment group markization back.
Relatively, difference has the significance meaning before and after the total points treatment of eight main effects indexs of matched group markization back.
Relatively, difference does not have the significance meaning between the group of total points treatment front and back, two groups eight main effects index markization backs difference.
(3) two groups of treatment back comprehensive therapeutic effect clinical meanings relatively
In the table 1 two groups of treatment back comprehensive therapeutic effects are carried out statistical analysis, compared the statistical significance after two groups are treated.For two groups of treatment back curative effects, also need use " relative risk reduction rate " (Relative risk reduction, RRR), " the routine number that needs treatment " (Number needed to treat, NTT), carry out " clinical meaning " of two groups of treatment back differences and analyze, further objective evaluation is subjected to the effect of reagent thing.
Specifically be calculated as follows
(4):
" relative risk reduction rate " (Relative risk reduction, RRR)=(matched group deterioration rate-treatment group deterioration rate)/matched group deterioration rate
" absolute risk reduction rate " (Absolute risk reduction, ARR)=matched group deterioration rate-treatment group deterioration rate NNT (Number needed to treat)=1/ (matched group deterioration rate-treatment group deterioration rate)
P
c(matched group " deterioration rate ")=13/66=0.20
P
t(treatment group " deterioration rate ")=8/63=0.13
RRR＝(P
c-P
t)/P
c＝(0.20-0.13)/0.20＝0.35
ARR＝P
c-P
t＝0.20-0.13＝0.07
NNT＝1/0.07＝14
Usually, RRR 〉=25% promptly has been considered to clinical meaning
(4)This research RRR is 35%, can think that the investigational agent and the curative effect difference of contrast medicine have bigger clinical meaning.
NNT=14 shows and whenever treats 14 routine patients AD with investigational agent and can reduce by 1 people sb.'s illness took a turn for the worse also have bigger clinical meaning.
(4) two groups of MMSE total points curative effects relatively
Table 3. liang group MMSE total points curative effect is (before difference=treatment back-treatment) relatively
z 0.420
Rank test between group
P 0.674
Relatively, difference has the significance meaning before and after the treatment of treatment group MMSE total points.Treatment back MMSE total points obviously improves before the treatment.
Relatively, difference has the significance meaning before and after the treatment of matched group MMSE total points.Treatment back MMSE total points obviously improves before the treatment.
Relatively, difference does not have the significance meaning between the group of two groups of MMSE total points treatment front and back differences.
Seven discuss
Among the 141 routine alzheimer disease patients, the kidney invigorating Fructus Alpiniae Oxyphyllae side group 69 examples (wherein lose and visit several 6 examples of example), huperzine A group 72 examples (wherein lose and visit several 6 examples of example).Comprehensive therapeutic effect is the result show, the kidney invigorating Fructus Alpiniae Oxyphyllae side obvious effective rate is 61.9%, and effective percentage is 9.5%, and coefficient of stabilization is 15.9%, and progression rates is 12.7%; Huperzine A (huperzine A) obvious effective rate is 50.0%, and effective percentage is 18.2%, and coefficient of stabilization is 12.1%, and progression rates is 19.7%.Two groups relatively, the difference not statistically significant.
With reference to international therapeutic evaluation standard about AD, the clinical trial therapeutic evaluation should be paid attention to statistical significance, also will pay attention to its clinical meaning.This research is used " relative risk reduction rate " and (RRR) is reached " the routine number that needs treatment " (NNT) to judge the clinical meaning of two groups of curative effect differences.The result shows, RRR is 35% (RRR 〉=25% promptly has been considered to clinical meaning usually), NNT is 14 and (shows and whenever treat 14 routine patients AD with investigational agent and can reduce by 1 people sb.'s illness took a turn for the worse, also have bigger clinical meaning), this shows that the kidney invigorating Fructus Alpiniae Oxyphyllae side and huperzine A curative effect difference have bigger clinical meaning.
It is generally acknowledged, the nature process of patient's AD state of an illness, if with MMSE is measurement, annual average 3 minutes [the Leon J.Thal.Clinical Trial in Alzheimer Desease.in:Robert D.Terry et al.ed.Alzheimer Disease.P431-44New York:Raven Press 1994] that reduce.The variation of MMSE score value can be used as the evaluation index of reflection treatment intervening measure to patient's AD memory and cognitive function effect to a certain extent.This development test group is through trimestral treatment, and the mean scores of its MMSE has increased by 3.17 fens, can think, the trimestral treatment of medicine of the present invention can delay about 2 years disease progression for AD patient.It is substantially parallel with the variation of MMSE that this studies other variations about Memory and Cognition scale score value treatment front and back.
The specific embodiment
Further describe the present invention by the following examples, this embodiment only is used to the present invention is described and to the present invention without limits.
Embodiment 1
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Embodiment 2
A. the consumption of filling a prescription: Fructus Cnidii 1000g, Radix Ginseng 1000g, Fructus Lycii 600g, Fructus Ligustri Lucidi 600g, Radix Polygoni Multiflori Preparata 600g, Cortex Moutan 600g, Borneolum Syntheticum 4g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Embodiment 3
A. the consumption of filling a prescription: Fructus Cnidii 200g, Radix Ginseng 200g, Fructus Lycii 200g, Fructus Ligustri Lucidi 200g, Radix Polygoni Multiflori Preparata 200g, Cortex Moutan 200g, Borneolum Syntheticum 4g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Embodiment 4
A. the consumption of filling a prescription: Fructus Cnidii 800g, Radix Ginseng 800g, Fructus Lycii 480g, Fructus Ligustri Lucidi 480g, Radix Polygoni Multiflori Preparata 480g, Cortex Moutan 480g, Borneolum Syntheticum 4g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Embodiment 5
A. the consumption of filling a prescription: Fructus Cnidii 480g, Radix Ginseng 480g, Fructus Lycii 320g, Fructus Ligustri Lucidi 320g, Radix Polygoni Multiflori Preparata 320g, Cortex Moutan 320g, Borneolum Syntheticum 4g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Embodiment 6
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 3 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 50% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.20 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata are with 70% alcohol reflux 1 time, and consumption is 6 times of crude drug amounts, extracts 1.5 hours, filters, and merging filtrate reclaims ethanol, is evaporated to relative density and is the extractum of 1.40 (60 ℃ of surveys), and is standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 0.5% chitosan-acetic acid solution, are incubated 0.4 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 0.5, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 70% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.20 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 3% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.40 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Embodiment 7
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 5 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.09 (60 ℃ of surveys) I clear paste, and adding ethanol is 70% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 90% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,60 ℃ add 1.5% chitosan-acetic acid solution, are incubated 1 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1.5, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 90% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.40 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add starch 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, mixing, and tabletting, promptly.
Embodiment 8
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add lactose 20.0g, stir evenly, drying and granulating is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder and 0.5 magnesium stearate, mixing, and tabletting is made tablet.
Embodiment 9
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add entry and stir evenly evenly, continue to add paeonol and pass through beta cyclodextrin that (the Borneolum Syntheticum mixing of enclose of β-CD) is made injection.
Embodiment 10
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add the 5g meglumine, the dissolving of 5%NalCl solution continues to add paeonol and (the Borneolum Syntheticum mixing of enclose of β-CD), freeze-dried powder is made in lyophilization through beta cyclodextrin.
Embodiment 11
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, (mixed proportion is medicine: Polyethylene Glycol-6000=1: 3), change material for 90 ℃, 8 ℃ of liquid paraffin are condensing agent, drip into drop pill to add paeonol, finely divided ice and Polyethylene Glycol-6000.
Embodiment 12
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, (mixed proportion is medicine: Polyethylene Glycol-6000=1: 3), change material for 90 ℃, 8 ℃ of liquid paraffin are condensing agent, drip into drop pill to add paeonol, finely divided ice and Polyethylene Glycol-6000.
Embodiment 13
A. the consumption of filling a prescription: Fructus Cnidii 625g, Radix Ginseng 625g, Fructus Lycii 417g, Fructus Ligustri Lucidi 417g, Radix Polygoni Multiflori Preparata 417g, Cortex Moutan 417g, Borneolum Syntheticum 4.2g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the polyamide column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Embodiment 14
A. the consumption of filling a prescription: Fructus Cnidii 1000g, Radix Ginseng 1000g, Fructus Lycii 600g, Fructus Ligustri Lucidi 600g, Radix Polygoni Multiflori Preparata 600g, Cortex Moutan 600g, Borneolum Syntheticum 4g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the polyamide column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Embodiment 15
A. the consumption of filling a prescription: Fructus Cnidii 200g, Radix Ginseng 200g, Fructus Lycii 200g, Fructus Ligustri Lucidi 200g, Radix Polygoni Multiflori Preparata 200g, Cortex Moutan 200g, Borneolum Syntheticum 4g;
B. Cortex Moutan vapor distillation, it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying, paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and being evaporated to relative density is 1.08 (60 ℃ of surveys) clear paste, and adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, and filtrate decompression is concentrated into the extractum that relative density is 1.30 (60 ℃ of surveys), and is standby;
C. Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 6 times for the first time, extracted 5 times of the second time 1.5 hours with 80% alcohol reflux 2 times, extracted 1.0 hours, and filtered merging filtrate, reclaim ethanol, be evaporated to relative density and be the extractum of 1.30 (60 ℃ of surveys), standby;
D. Fructus Lycii decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the polyamide column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is the extractum of 1.30 (60 ℃ of surveys), and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, and being evaporated to relative density is the extractum of 1.30 (60 ℃ of surveys);
E. merge with above-mentioned extractum, add micropowder silica gel 15.0g, stir evenly, vacuum drying (vacuum 0.08～0.09Mpa, 60～70 ℃ of temperature) is pulverized, and medicated powder adds paeonol, Borneolum Syntheticum fine powder, and mixing is encapsulated, promptly.
Claims (12)
1. Chinese medicine composition for the treatment of alzheimer disease, said composition is prepared from by the medical material of following weight proportion:
100～200 parts of Fructus Cnidiis, 100～200 parts of Radix Ginsengs, 75～125 parts of Fructus Lycii, 75～125 parts of Fructus Ligustri Lucidi, 75～125 parts of Radix Polygoni Multiflori Preparatas, 75～125 parts of Cortex Moutans, 0.5～2 part of Borneolum Syntheticum.
2. compositions according to claim 1, said composition is prepared from by the medical material of following weight proportion:
150 parts of Fructus Cnidiis, 150 parts of Radix Ginsengs, 100 parts of Fructus Lycii, 100 parts of Fructus Ligustri Lucidi, 100 parts of Radix Polygoni Multiflori Preparatas, 100 parts of Cortex Moutans, 1 part of Borneolum Syntheticum.
3. compositions according to claim 1, said composition is prepared from by the medical material of following weight proportion:
148.8 parts of Fructus Cnidiis, 148.8 parts of Radix Ginsengs, 99.3 parts of Fructus Lycii, 99.3 parts of Fructus Ligustri Lucidi, 99.3 parts of Radix Polygoni Multiflori Preparatas, 99.3 parts of Cortex Moutans, 1 part of Borneolum Syntheticum.
4. the compositions any according to claim 1-3, wherein said compositions are made into acceptable preparation on the pharmaceutics.
5. compositions according to claim 4, acceptable preparation is tablet, capsule, granule, injection, drop pill on the wherein said pharmaceutics.
6. compositions according to claim 5, acceptable preparation is a capsule on the wherein said pharmaceutics.
7. the described preparation of compositions method of claim 1 is characterized in that it is to be prepared from by the following step:
By weight ratio, get following raw material ready:
A. 100～200 parts of Fructus Cnidiis, 100～200 parts of Radix Ginsengs, 75～125 parts of Fructus Lycii, 75～125 parts of Fructus Ligustri Lucidi, 75～125 parts of Radix Polygoni Multiflori Preparatas, 75～125 parts of Cortex Moutans, 0.5～2 part of Borneolum Syntheticum;
B. get the Cortex Moutan vapor distillation, get paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby; Medicinal liquid after the distillation filters, and concentrates, and the alcohol precipitation filters, and filtrate decompression is condensed into extractum, and is standby;
C. get Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata alcohol reflux, filter, merging filtrate reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is standby;
D. get the Fructus Lycii extracting in water, filter, collecting decoction concentrates, and adds chitosan-acetic acid solution, and insulation is placed, and filters, and macroporous resin column filtrate on washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, and is concentrated standby;
Macroporous resin column reuse ethanol elution is collected eluent, reclaims ethanol, and concentrating under reduced pressure becomes extractum, and is standby; The cation exchange resin column of having handled well on the above-mentioned concentrated solution washes with water to effluent closely colourlessly earlier, and reuse ammonia spirit eluting is collected eluent, and concentrating under reduced pressure becomes extractum;
E. merge with above-mentioned extractum, add paeonol, Borneolum Syntheticum fine powder, mixing is made preparation.
8. method according to claim 7, wherein preserve down in 3-5 ℃ the distillation of Cortex Moutan described in step b back, and the dry paeonol that gets of sucking filtration thing is broken into fine powder with Borneolum Syntheticum powder, and is standby; Medicinal liquid after the described distillation filters, and being concentrated into relative density is 1.05～1.10, adds ethanol to containing alcohol amount 50%-70%, filters, and filtrate decompression is concentrated into the extractum that relative density is 1.20-1.40, and is standby.
9. method according to claim 7, wherein Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata 70%-90% alcohol reflux 1-3 time among the step c filters, and merging filtrate reclaims ethanol and is concentrated into the extractum that relative density is 1.20-1.40, and is standby.
10. method according to claim 7, wherein Fructus Lycii water extraction 1-3 time in the steps d filters, and collecting decoction is concentrated into 1: 0.3-0.5,40-60 ℃ adds the 0.5-1.5% chitosan-acetic acid solution, be incubated 0.4-1 hour, place, filter, D101 macroporous resin column on the filtrate, wash with water to effluent closely colourlessly earlier, merge, be concentrated into 1: 0.5-1.5 by liquid and water lotion; The ethanol elution of macroporous resin column reuse 70%-80% is collected eluent, reclaims ethanol, and concentrating under reduced pressure becomes relative density to be the extractum of 1.20-1.40, and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 3-7% ammonia spirit eluting is collected eluent, and it is the extractum of 1.20-1.40 that concentrating under reduced pressure becomes relative density.
11. method according to claim 7 wherein merges with above-mentioned extractum among the step e, adds micropowder silica gel, paeonol, Borneolum Syntheticum fine powder, mixing, and vacuum drying incapsulates, and gets capsule.
12. a preparation method for the treatment of the Chinese medicine composition of alzheimer disease is characterized in that it is to be prepared from by the following step:
A gets 100～200 parts of following raw material Fructus Cnidiis, 100～200 parts of Radix Ginsengs, 75～125 parts of Fructus Lycii, 75～125 parts of Fructus Ligustri Lucidi, 75～125 parts of Radix Polygoni Multiflori Preparatas, 75～125 parts of Cortex Moutans, 0.5～2 part of Borneolum Syntheticum ready by weight ratio;
B gets the Cortex Moutan vapor distillation, and it is an amount of to collect distillate, in 4 ℃ of cold preservations, sucking filtration, sucking filtration thing drying gets paeonol, be broken into fine powder with Borneolum Syntheticum powder, standby, the medicinal liquid after the distillation filters, being evaporated to relative density is 1.08 clear paste, adding ethanol is 60% to containing the alcohol amount, leaves standstill, and filters, it is 1.30 extractum that filtrate decompression is concentrated into relative density, standby;
C gets Fructus Cnidii, Radix Ginseng, Fructus Ligustri Lucidi, Radix Polygoni Multiflori Preparata with 80% alcohol reflux 2 times, and 6 times for the first time, extracted 1.5 hours, 5 times for the second time, extracted 1.0 hours, filtration, merging filtrate, recovery ethanol is evaporated to relative density and is 1.30 extractum, and is standby;
D gets Fructus Lycii and decocts with water secondary, and 6 times for the first time, 5 times for the second time, the each decoction 1.0 hours filters, and collecting decoction is concentrated into 1: 0.4,50 ℃ add 1% chitosan-acetic acid solution, are incubated 0.5 hour, place, filter, the D101 macroporous resin column of having handled well on the filtrate washes with water to effluent closely colourlessly earlier, merges by liquid and water lotion, be concentrated into 1: 1, concentrated solution is standby; The ethanol elution of macroporous resin column reuse 80% is collected eluent, reclaims ethanol, is evaporated to relative density and is 1.30 extractum, and is standby; The 732 type cation exchange resin columns of having handled well on the above-mentioned concentrated solution wash with water to effluent closely colourlessly earlier, and reuse 5% ammonia spirit eluting is collected eluent, are evaporated to relative density and are 1.30 extractum;
The above-mentioned extractum of e merges, and adds micropowder silica gel, paeonol, Borneolum Syntheticum fine powder, and vacuum drying incapsulates, and gets capsule.
13. the application of the described any Chinese medicine composition of claim 1-3 in preparation treatment alzheimer disease medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006101129161A CN101143181B (en) | 2006-09-12 | 2006-09-12 | Traditional Chinese medicinal composition for treating senile dementia and preparation method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006101129161A CN101143181B (en) | 2006-09-12 | 2006-09-12 | Traditional Chinese medicinal composition for treating senile dementia and preparation method and application thereof |
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| CN103479855A (en) * | 2013-09-16 | 2014-01-01 | 青岛中仁药业有限公司 | Preparation method of Chinese materia medica preparation for treating senile dementia |
| CN105148072A (en) * | 2015-09-30 | 2015-12-16 | 郑梅 | Preparation for treating senile dementia and preparation method |
| GB2547241A (en) * | 2016-02-11 | 2017-08-16 | Akl Res & Dev Ltd | Anti-inflammatory formulation |
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| CN1438005A (en) * | 2003-03-14 | 2003-08-27 | 山东中医药大学 | Medicine for vascular denmentia disease and preparation method |
| CN1582979A (en) * | 2003-09-04 | 2005-02-23 | 深圳万基药业有限公司 | Brain and intellectual health care medicine and its preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1438005A (en) * | 2003-03-14 | 2003-08-27 | 山东中医药大学 | Medicine for vascular denmentia disease and preparation method |
| CN1582979A (en) * | 2003-09-04 | 2005-02-23 | 深圳万基药业有限公司 | Brain and intellectual health care medicine and its preparation |
Non-Patent Citations (4)
| Title |
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| 张魁华 等.补肾益智方对老年性痴呆模型动物定位航行学习记忆功能的改善作用.中草药33 10.2002,33(10),917-920. |
| 张魁华等.补肾益智方对老年性痴呆模型动物定位航行学习记忆功能的改善作用.中草药33 10.2002,33(10),917-920. * |
| 高洁 等.补肾益智方对Alzheimer 病模型大鼠脑内β-淀粉样前体蛋白的影响.中国中西医结合杂志22 9.2002,22(9),677-679. |
| 高洁等.补肾益智方对Alzheimer 病模型大鼠脑内β-淀粉样前体蛋白的影响.中国中西医结合杂志22 9.2002,22(9),677-679. * |
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