CN105194352A - Traditional Chinese medicine composition capable of improving learning and memory abilities and preparation method thereof - Google Patents

Traditional Chinese medicine composition capable of improving learning and memory abilities and preparation method thereof Download PDF

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Publication number
CN105194352A
CN105194352A CN201510753667.3A CN201510753667A CN105194352A CN 105194352 A CN105194352 A CN 105194352A CN 201510753667 A CN201510753667 A CN 201510753667A CN 105194352 A CN105194352 A CN 105194352A
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chinese medicine
medicine composition
preparation
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traditional chinese
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CN105194352B (en
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赵友兴
孔凡栋
周丽曼
马青云
黄圣卓
戴好富
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Institute of Tropical Bioscience and Biotechnology Chinese Academy of Tropical Agricultural Sciences
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Institute of Tropical Bioscience and Biotechnology Chinese Academy of Tropical Agricultural Sciences
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Abstract

The invention relates to the field of traditional Chinese medicines and discloses a traditional Chinese medicine composition as well as a preparation method and application thereof. The traditional Chinese medicine composition disclosed by the invention is prepared from 4-12 parts of ganoderma lucidum, 2-5 parts of rhizoma gastrodiae, 3-7 parts of morinda root, 2-5 parts of astragalus root and 3-8 parts of pseudo-ginseng. The traditional Chinese medicine composition disclosed by the invention is prepared from ganoderma lucidum, rhizoma gastrodiae, morinda root, astragalus root and pseudo-ginseng as raw materials and is simple in formula. The raw materials interact and are synergistic to play a good role in improving memory. The traditional Chinese medicine composition is free of toxic or side effect to a human body, is free of drug dependence, and can be widely used for preparing medicines capable of improving learning and memory abilities and treating senile dementia. The preparation method of the traditional Chinese medicine composition, disclosed by the invention, comprises the steps of mixing the ganoderma lucidum, the rhizoma gastrodiae, the morinda root, the astragalus root and the pseudo-ginseng according to a certain proportion and then extracting with ethanol. Effective ingredients of all the raw materials are farthest kept. The prepared traditional Chinese medicine composition has an obvious effect on improving memory, is simple in operation and is suitable for industrial production.

Description

A kind of Chinese medicine composition improving learning and memory and preparation method thereof
Technical field
The present invention relates to tcm field, be specifically related to a kind of Chinese medicine composition improving learning and memory and its preparation method and application.
Background technology
Modern society's rhythm of life is accelerated gradually, increasingly competitive, causes amnesia crowd to grow with each passing day.Along with the fast development of economic society, China just steps into aging society, there is hypomnesis phenomenon in increasing old man, even suffer from senile dementia, the old man that data show about 5%-15% suffers from senile dementia in various degree, brings very large mental burden and financial burden to society and family.Senile dementia has become the fourth-largest killer of old man's death, and prevention and therapy senile dementia is very urgent.
One of main manifestations of senile dementia is significantly going down of learning and memory function.Learning and Memory is all the Premium Features of brain, and the experimental results shows that all there is inseparable contacting in many specific paries of brain such as cerebral hippocampus district etc. with Learning and Memory function.But Learning and Memory is two not identical nervous process be closely connected: in learning process, the nervous system of body constantly accepts external environment change, therefrom obtains new information and experience, and changes self behavior as guidance; Memory Process is then the experience obtained in learning process and information are carried out storing, keeping and reproduced in good time in brain.Learning and memory has reacted human and animal to objective external cognitive function, is also that the mankind can adapt to and transform the primary condition of external environment, is the important indicator weighing level of intelligence.Therefore, the improvement of learning and memory ability is the important goal for the treatment of senile dementia, find can the medicine of improving studing ability also significant to research treatment senile dementia.
Senile dementia pathogeny it be unclear that, but more research think may with nervous system reduce produce neurotransmitter acetylcholine relevant.Current clinical treatment senile dementia mainly adopts western medical treatment, and western medical treatment senile dementia mainly adopts cholinesterase inhibitor (as donepezil, galantamine etc.).But this kind of medicine life-time service has certain toxic and side effects, and easily produce dependency to medicine, thus searching can improve learning and memory, prevent the natural drug of senile dementia very necessary.
Compared with Western medicine, Chinese medicine has higher safety.At present, the Chinese medicine preparation for the treatment of dysmnesia and senile dementia need exploitation.Therefore, the tcm product researching and developing a kind of efficient, safe improvement learning and memory and prevention senile dementia has significant Social and economic benef@prospect to human society.
Summary of the invention
In view of this, the object of the invention is to provide a kind of Chinese medicine composition improving learning and memory and preparation method thereof and application.
For realizing object of the present invention, the present invention adopts following technical scheme:
A kind of Chinese medicine composition, be made up of the raw material of following weight portion:
Ganoderma 4-12 part, Rhizoma Gastrodiae 2-5 part, Radix Morindae Officinalis 3-7 part, Radix Astragali 2-5 part, Radix Notoginseng 3-8 part.
In some embodiments, Chinese medicine composition of the present invention is made up of following raw material:
Ganoderma 5 parts, 2 parts, Rhizoma Gastrodiae, Radix Morindae Officinalis 3 parts, the Radix Astragali 2 parts, Radix Notoginseng 3 parts.
Present invention also offers a kind of preparation method of Chinese medicine composition, with parts by weight, get Ganoderma 4-12 part, Rhizoma Gastrodiae 2-5 part, Radix Morindae Officinalis 3-7 part, Radix Astragali 2-5 part, Radix Notoginseng 3-8 part, ethanol extraction, filter, collect filtrate.
In some embodiments, the preparation method of Chinese medicine composition of the present invention, described ethanol extraction is alcohol reflux.
In some preferred embodiments, the preparation method of Chinese medicine composition of the present invention, described alcohol reflux is extract crude drug 1-2 time, each 60min with crude drug gross weight 5-7 50%-90% alcohol heating reflux doubly.
In some embodiments, the preparation method of Chinese medicine composition of the present invention, is also included in the step that filtrate is condensed into thick paste by less than 60 DEG C.
In some preferred embodiments, the preparation method of Chinese medicine composition of the present invention, the relative density of described thick paste is 1.10-1.15.
Present invention also offers compositions prepared by described preparation method.
Present invention also offers the application that described compositions is improved learning and memory in preparation and treated in the medicine of senile dementia.
Present invention also offers a kind of pharmaceutical preparation, be made up of the Chinese medicine composition of the present invention of effective dose and pharmaceutically acceptable adjuvant.
Preferably, described pharmaceutical preparation is tablet, granule, capsule, powder, pill or oral liquid.
Chinese medicine composition of the present invention selects Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng to be that raw material is made, and formula is simple, and influence each other, synergism, plays the effect of good Improving memory power.The preparation method of Chinese medicine composition of the present invention is by obtained for the mixed ethanol extraction by a certain percentage of Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng, farthest remain the effective ingredient of each raw material, the Chinese medicine composition Improving memory power effect Be very effective prepared, simultaneously simple to operate, be suitable for suitability for industrialized production.
Detailed description of the invention
Below in conjunction with the embodiment of the present invention, be clearly and completely described the technical scheme in the embodiment of the present invention, obviously, described embodiment is only the present invention's part embodiment, instead of whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art, not making the every other embodiment obtained under creative work prerequisite, belong to the scope of protection of the invention.
For realizing object of the present invention, the present invention adopts following technical scheme:
A kind of Chinese medicine composition, be made up of the raw material of following weight portion:
Ganoderma 4-12 part, Rhizoma Gastrodiae 2-5 part, Radix Morindae Officinalis 3-7 part, Radix Astragali 2-5 part, Radix Notoginseng 3-8 part.
The defect undesirable to the curative effect improving learning and memory for existing traditional Chinese medicine preparation product, Western medicine toxic and side effects is larger, under guidance of traditional Chinese medicine theory, applicant is in conjunction with modern Chinese medicine pharmacy and research practice experience for many years, select Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali and Radix Notoginseng Chinese medicine of the five flavours material to be raw material, make according to constant weight prescription.
Wherein, Ganoderma is also known as Lin Zhongling (formal name used at school: GanodermaLucidumKarst), best with the Ganoderma grown in woods.Profile is umbrella, cap kidney shape, semicircle or subcircular, is the sporophore of On Polyporaceae Ganoderma.Ganoderma sweet in the mouth is put down, and enters heart channel, has effect of invigorating QI and tranquilization, relieving cough and asthma, can be used for malaise, insomnia cardiopalmus, asthenia cough with asthma.
Rhizoma Gastrodiae (formal name used at school: GastrodiaelataBl.), have another name called rhizoma gastrodiae, solely shake sesame, Bai Longpi etc., it is the orchid family Gastrodia herbaceos perennial, sweet in the mouth, property are flat, enter Liver Channel, there is endogenous wind stopping, arresting convulsion, cure mainly dizzy+dizzy pupil, wind syndrome of head headache, numb limbs and tense tendons, hemiplegia, aphasia, pediatric epilepsy scared wind symptom.
Radix Morindae Officinalis is the dry root of Maguireothamnus speciosus Radix Morindae Officinalis Morindaojj:icinalisHow, sweet in the mouth, pungent, slightly warm in nature, returns kidney, Liver Channel, has kidney-replenishing, bone and muscle strengthening, the effects such as wind-damp dispelling, menoxenia infertile for impotence and seminal emission, cold womb, few abdomen cold type of pain, rheumatic arthralgia, muscles and bones flaccidity are soft.
The Radix Astragali has another name called Radix Astragali, for leguminous herbaceous plant's Radix Astagali, Radix Astragali dry root, warm in nature, sweet in the mouth, return lung, spleen channel, there is the effects such as invigorating QI to consolidate the body surface resistance, diuretic detumescent, expelling pus and toxin by strengthening QI, granulation promoting, chronic diarrhea proctoptosis, spontaneous perspiration, edema weak for the deficiency of vital energy, sub-official prolapsus, chronic nephritis proteinuria, diabetes, open sore part disunion of a specified duration.
Radix Notoginseng is the dry root welding technology of panax araliaceae plant Panaxnotoginseng (Burk.) F.H.Chen.Radix Notoginseng sweet in the mouth, micro-hardship, warm in nature, return liver, stomach warp, there is dissipating blood stasis hemostasis, subduing swelling and relieving pain, cure mainly spitting of blood, haematemesis, epistaxis, have blood in stool, metrorrhagia, traumatic hemorrhage, breast ventral spine bitterly, tumbling and swelling.
In Chinese medicine composition of the present invention, Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng influence each other, synergism, significantly can improve learning and memory.Compositions of the present invention medical material used is both without any toxicity, and also without any drug dependence, long-term edible dependency is little, and cheap, and applicable ordinary consumer eats, and has wide market prospect.
Ganoderma described in the present invention, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng well known to a person skilled in the art, can by commercial sources buy from a medical store obtain or by method disclosed in prior art cultivation, gathering prepares, its specification meets country or industry standard.
In embodiments more provided by the invention, compositions of the present invention is made up of following raw material:
Ganoderma 5 parts, 2 parts, Rhizoma Gastrodiae, Radix Morindae Officinalis 3 parts, the Radix Astragali 2 parts, Radix Notoginseng 3 parts.
Present invention also offers the preparation method of described compositions.
A preparation method for Chinese medicine composition, with parts by weight, gets Ganoderma 4-12 part, Rhizoma Gastrodiae 2-5 part, Radix Morindae Officinalis 3-7 part, Radix Astragali 2-5 part, Radix Notoginseng 3-8 part, ethanol extraction, filters, and collects filtrate.
Wherein, described raw material medicines in portions by weight number is preferably:
Ganoderma 5 parts, 2 parts, Rhizoma Gastrodiae, Radix Morindae Officinalis 3 parts, the Radix Astragali 2 parts, Radix Notoginseng 3 parts.
The alcohol extraction procedure adopted in preparation method of the present invention is this area general extraction methods, can be percolation, infusion process or reflux extraction.As preferably, ethanol extraction described in preparation method of the present invention is alcohol reflux.
In some embodiments, described alcohol reflux is preferably and extracts crude drug 1-2 time, each 60min with crude drug gross weight 5-7 50%-90% alcohol heating reflux doubly.。
In addition, make various medicament more easily for the ease of Chinese medicine composition of the present invention, preparation method of the present invention is also included in less than 60 DEG C, and the filtrate of gained after ethanol extraction is condensed into thick paste.
Wherein, in some preferred embodiments, the relative density of described thick paste is preferably 1.10-1.15.
Present invention also offers Chinese medicine composition prepared by above-mentioned preparation method.
In a specific embodiment, the present invention adopts Jumping test to detect the effect of Chinese medicine composition of the present invention to the learning and memory of mice aging model and detects, result shows Chinese medicine composition of the present invention in step down test, incubation period increases, errors number reduces, and Learning and Memory achievement is obviously improved.
In a specific embodiment, the present invention adopts water maze laboratory to detect the space exploration ability of Chinese medicine composition of the present invention to mice aging model, result display exhausted mining areas is after taking Chinese medicine composition of the present invention continuously, space exploration ability is obviously improved, and declining to old and feeble caused Spatial memory power improves significantly.
Cerebral hippocampal district is the important brain district of learning and memory, take part in the Learning and Memory of various ways.In mouse brain hippocampal tissue, acetylcholinesterase (AChE) activity is the important indicator that evaluation medicine affects learning and memory.In a specific embodiment, the present invention have detected step down test and water maze test terminate after Hippocampus of Mice in, acetylcholinesterase (AChE) is active, and result shows acetylcholinesterase (AChE) activity in the Hippocampus of Mice of Chinese medicine composition test group of the present invention and obviously suppressed.
Meanwhile, in the acute toxicity of Chinese medicine composition of the present invention and the research of long term toxicity, do not find that Chinese medicine composition of the present invention has any untoward reaction, to each organ not damaged.In clinical trial, Chinese medicine composition of the present invention has significant curative effect to improving learning memory, and has no side effect and drug dependence.
Therefore, present invention also offers the application that described Chinese medicine composition improves learning and memory in preparation and treats in the medicine of senile dementia.
Chinese medicine composition of the present invention can be prepared into various conventional formulation clinically by this area conventional formulation method, such as, pharmaceutically acceptable adjuvant can be added in the Chinese medicine composition of effective dose of the present invention, such as disintegrating agent, lubricant, adhesive, dispersant etc., with conventional formulation method, be prepared into various common dosage forms.The present invention preferably makes tablet, granule, capsule, powder, pill or oral liquid.
To those skilled in the art, when knowing active component, according to the formulation method of routine, various pharmaceutical products can be made easily, the adjuvant simultaneously adopted in preparation is also well known in the art, as carboxymethyl starch sodium, cane sugar powder, Mel, Semen Sesami wet goods.
Using dosage and the using method of Chinese medicine composition of the present invention depend on factors, comprise the subjective judgment of the age of user, body weight, sex, natural health situation, nutriture, the activity intensity of compound, service time, metabolic rate, the course of disease order of severity and diagnosis and treatment doctor.Those skilled in the art easily can determine using dosage and the using method of described Chinese medicine composition according to above-mentioned factor.
Chinese medicine composition of the present invention selects Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng to be that raw material is made, and formula is simple, and influence each other, synergism, plays the effect well improving learning and memory.The preparation method of Chinese medicine composition of the present invention is by obtained for the mixed ethanol extraction by a certain percentage of Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng, farthest remain the effective ingredient of each raw material, it is remarkable that the Chinese medicine composition prepared improves learning and memory action effect, simultaneously simple to operate, be suitable for suitability for industrialized production.
For a better understanding of the present invention, below in conjunction with specific embodiment, the present invention is described in detail.
Embodiment 1: Chinese medicine composition of the present invention
By following weight take each raw material (unit: g):
Ganoderma 500, Rhizoma Gastrodiae 200, Radix Morindae Officinalis 300, the Radix Astragali 200, Radix Notoginseng 300.
Preparation method: get Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng, add 6 times to 80% alcohol reflux 2 times of crude drug gross weight, each 60min, filter, filtrate is evaporated to the thick paste that relative density is 1.10-1.15 below 60 DEG C, spraying dry.
Embodiment 2: Chinese medicine composition of the present invention
By following weight take each raw material (unit: g):
Ganoderma 700, Rhizoma Gastrodiae 300, Radix Morindae Officinalis 400, the Radix Astragali 300, Radix Notoginseng 400.
Preparation method: get Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng, add 5 times to 60% alcohol reflux 2 times of crude drug gross weight, each 60min, filter, filtrate is evaporated to the thick paste that relative density is 1.10-1.15 below 60 DEG C, spraying dry.
Embodiment 3: Chinese medicine composition of the present invention
By following weight take each raw material (unit: g):
Ganoderma 1200, Rhizoma Gastrodiae 500, Radix Morindae Officinalis 700, the Radix Astragali 500, Radix Notoginseng 800.
Preparation method: get Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng, add 7 times to 50% alcohol reflux 2 times of crude drug gross weight, each 60min, filter, filtrate is evaporated to the thick paste that relative density is 1.10-1.15 below 60 DEG C, spraying dry.
Embodiment 4: Chinese medicine composition of the present invention
By following weight take each raw material (unit: g):
Ganoderma 1000, Rhizoma Gastrodiae 400, Radix Morindae Officinalis 600, the Radix Astragali 400, Radix Notoginseng 700.
Preparation method: get Ganoderma, Rhizoma Gastrodiae, Radix Morindae Officinalis, the Radix Astragali, Radix Notoginseng, adds 6 times to 90% alcohol reflux 1 time of crude drug gross weight, 60min, filters, filtrate is evaporated to the thick paste that relative density is 1.10-1.15 below 60 DEG C, spraying dry.
Embodiment 5: Chinese medicine composition of the present invention is to the pharmacy test of mice
1, experimental animal: Kunming mouse 100, purchased from Hainan Medical College's Experimental Animal Center, male and female half and half, average weight is 20g.
2, test grouping: mice is divided into 5 groups at random, is respectively Chinese medicine composition group described in matched group, aging model group, embodiment 1, positive controls (containing two groups: huperzine A group, piracetam group), often organizes male and female half and half.Wherein, Chinese medicine composition group and positive controls described in aging model group, embodiment 1 respectively with 0.5%D-galactose according to the capable lumbar injection of the dosage of 50mg/kg, every day 1 time, continuously injection 6 weeks, to make aging model, matched group injects normal saline.In injection the 4th week, to take medicine thing or distilled water 4 weeks according to dosage to continuously respectively each group of mouse stomach, once a day.
3, experimental technique:
3.1 mice step down tests: the 4th week that takes medicine continuously, start after administration 1.5h to carry out mice step down test.Mice is put into diving tower instrument, conform 3min, passes to the alternating current of 36V immediately.After being shocked by electricity, most mice meeting rebound platform is to hide injury.In record 5min, mice first time jumps off mice in time (incubation period) of platform, time in Safe period and jumps off platform number of times (errors number), in this, as school grade.After 24h, carry out memory consolidation test, be first put on platform by mice, record mice first time jumps off the time mice in (incubation period), time in Safe period and jumps off platform number of times (errors number), in this, as Memory result.
3.2, mice Morris water maze test: the 4th week of successive administration, starts after administration 3h to carry out Morris water maze test.Performance testing comprises (1) location navigation test: allow mice free swimming 2min in pond, test lasts 4d, and record finds the time (escape latency) of platform and path of swimming at every turn.Then drawn upper mounting plate as can not find platform in 120s, incubation period is designated as 120s; (2) space exploration test: the 5th afternoon removes platform, the swimming path of Mus in pond and time in record 2min, swimming time in original platform quadrant swim time, 40cm ring centered by platform, and analyze the percentage ratio accounting for total path length in original platform quadrant swim path.With the change of above-mentioned index observing space learning, memory.
3.3, the mensuration that Hippocampus of Mice acetylcholinesterase (AChE) is active: after mice step down test and water maze test all terminate, put to death each group of mice immediately, take out the Hippocampus in Mice brain tissues, put in glass homogenizer and add the cerebral hippocampal homogenate that pre-cold saline makes 10% (g/mL), with the centrifugal 10min of 3600r/min, get supernatant.Acetylcholinesterase (AChE) in Hippocampus of Mice is detected active by test kit description method.
4, experimental result
4.1 mice step down tests the results are shown in Table 1.
Table 1 medicine is on the impact of mice step down test
Note: * * P<0.01, compared with aging model group
As shown in Table 1, compare with aging model group, described in the embodiment of the present invention 1, the mice of Chinese medicine composition test group is in step down test, and incubation period increases, errors number reduces, and Learning and Memory achievement is obviously improved, with Western medicine group effect no significant difference.
According to the method described above, carry out mice step down test respectively to the Chinese medicine composition described in embodiment 2-4, result is similar to the Chinese medicine composition effect described in embodiment 1.Show that Chinese medicine composition of the present invention effectively can improve the ability of learning and memory of mice.
4.2 mice Morris water maze tests the results are shown in Table 2, table 3.
Table 2 respectively group mice 4d average escape latency compares
Grouping Dosage (g/kg) Number of cases Average latency
Blank group - 17 31.43±14.68**
Aging model group - 16 60.57±23.75
Embodiment 1 Chinese medicine composition group 4 16 40.63±20.63**
Huperzine A group 0.04 14 37.64±18.41**
Piracetam group 0.4 15 39.52±20.39**
Note: * * P<0.01, compared with aging model group
From table 2, aging model group mice average escape latency obviously extends than blank group, and Chinese medicine composition group described in embodiment 1 significantly shortens than aging model group, and there was no significant difference between Western medicine group piracetam.
Table 3 is group mice original platform quadrant swim time, path percentage when swimming time in 40cm ring respectively
Note: * * P<0.01, compared with aging model group
From table 3, aging model group mice primary image limits swimming time in swimming time and 40cm ring obviously to shorten than blank group, primary image limit path also obviously shortens, and Chinese medicine composition group described in embodiment 1 is than aging model group significant prolongation, primary image limit path also significant prolongation, and there was no significant difference between Western medicine group.
According to the method described above, carry out water maze test in mice test respectively to the Chinese medicine composition described in embodiment 2-4, result is similar to the Chinese medicine composition effect described in embodiment 1.
Comprehensive above-mentioned Mice water maze experimental result, exhausted mining areas finds platform and space exploration energy force rate blank group obviously goes down, and exhausted mining areas is taking Chinese medicine composition of the present invention after 4 weeks continuously, has clear improvement than aging model group.Especially being outstanding in space exploration process, the swimming track of exhausted mining areas mostly is does cisterna ambiens swimming around pool side, also have Chi Zhongzuo shuttle back and forth sample swimming, and it is similar with Western medicine group to take this Chinese medicine composition, how repeatedly to find near original platform position, swimming time significant prolongation in original platform quadrant and 40cm ring, the swimming path of original platform quadrant also obviously extends.Therefore, Chinese medicine composition of the present invention improves significantly to old and feeble caused Spatial memory power decline.
4.3 Hippocampus of Mice acetylcholinesterase (AChE) active testings the results are shown in Table 4.
Table 4 respectively group Hippocampus of Mice acetylcholinesterase (AChE) is active
Note: * P<0.05, compared with aging model group
As shown in Table 4, aging model group is compared with blank group, acetylcholinesterase (AChE) activity significantly improves, and in the Hippocampus of Mice of Chinese medicine composition test group described in the embodiment of the present invention 1, acetylcholinesterase (AChE) activity is obviously suppressed, and effect is better than Western medicine group piracetam.
According to the method described above, carry out Hippocampus of Mice acetylcholinesterase (AChE) active testing respectively to the Chinese medicine composition described in embodiment 2-4, result is similar to the Chinese medicine composition effect described in embodiment 1.In the Hippocampus of Mice of Chinese medicine composition test group described in embodiment of the present invention 2-4, acetylcholinesterase (AChE) activity is obviously suppressed.Show that compositions of the present invention can obviously improve learning and memory of little mouse power.
Embodiment 6: Chinese medicine composition toxicity research of the present invention
1, studies on acute toxicity
Get Kunming mouse, give medicine of the present invention (Chinese medicine composition prepared by embodiment 1) by 10g/kg gavage, 1 day successive administration 4 times, every minor tick 6h, then give normal diet, pathologic inspection is carried out to each organ, does not find organ disease.
2, long term toxicity research
Get Kunming mouse, in pressing, heavy dose of group of (4g/kg, 8g/kg) gavage gives medicine of the present invention (Chinese medicine composition prepared by embodiment 1), every day 1 time, successive administration is after 14 days, measure the indexs such as Mouse Weight, cardiac function, liver function, renal function, electrocardiogram, administration group compares with matched group respectively, shows no obvious abnormalities.The internal organs such as the pathological examination heart, liver,kidney,spleen, lung, Stomach duodenum, large intestine, small intestinal, adrenal gland and genitals, administration group compares with matched group respectively, is showed no obvious toxic and changes.
According to the method described above, respectively the acute toxicity of the Chinese medicine composition described in embodiment 2-4 and long term toxicity are detected, do not find that Chinese medicine composition described in embodiment of the present invention 2-4 has any untoward reaction, to each organ not damaged.Above result shows Chinese medicine composition safety non-toxic of the present invention, can be used for clinical.
Embodiment 7: the capsule of Chinese medicine composition of the present invention
Chinese medicine composition described in Example 1, adds carboxymethylstach sodium, fully mixes, and makes granule, loads No. 1 capsule, obtains capsule.
Embodiment 8: the tablet of Chinese medicine composition of the present invention
Chinese medicine composition described in Example 2, adds carboxymethylstach sodium, fully mixes, and sends into tablet machine and makes tablet.
Embodiment 9: the granule preparing Chinese medicine composition of the present invention
Chinese medicine composition described in Example 3, then adds the mixture of cane sugar powder and carboxymethylstach sodium, and mixing, makes granule.
Embodiment 10: the pill of Chinese medicine composition of the present invention
Chinese medicine composition described in Example 4, then adds pure Oleum sesami or Mel mixing, delivers to centrifugal making in ball machine and make pill.
Embodiment 11: clinical trial
1, subjects data
40 routine patients: age 65-80 year, 72 years old mean age; Male 22 example, women 18 example; Course of disease 1-10, average 5 years; Meet " Chinese Spirit classification of diseases scheme and diagnostic criteria "; Clinical manifestation is that hypomnesis, faculty of understanding and judgment decline.All cases confirm selected through mini-mental state inspection (MMSE), Chang Gu river Dementia scale (HDS), Congnitive scale (CAS).
2, Therapeutic Method and the standard of curative effect evaluation: Chinese medicinal composition capsules of the present invention (embodiment 7), oral, consumption is 1.5g/ time, sooner or later respectively once, within two months, is a course for the treatment of.
Therapeutic evaluation is carried out according to the increase and decrease point situation of mini-mental state inspection (MMSE) after patient treatment.
Effective: to increase and divide >=8 points, or reach 28 points
Effective: to increase and divide 4 ~ 7 points
Invalid: to increase and divide≤3 points
Worsen: increase a point < 0 point
3, observed result
Table 5 clinical efficacy
Result shows, Chinese medicinal composition capsules agent of the present invention 61 days, and therapeutic effect reaches effective, effective standard person and has 87.5%; Oral administration Chinese medicinal composition capsules agent of the present invention 122 days, therapeutic effect reaches effective, effective standard person and has 97.5% (table 5).After most of patients takes Chinese medicinal composition capsules agent one of the present invention course for the treatment of, the mental status has had obvious improvement, attention comparatively before more concentrated, memory comparatively before had obvious improvement.
4, toxic and side effects observed result: treat 40 routine patients, do not have a routine patient to occur any untoward reaction, rate that sb.'s illness took a turn for the worse is 0, illustrates that Chinese medicinal composition capsules agent of the present invention is safe to human body.
According to the method described above, detect respectively to the clinical efficacy of the pharmaceutical preparation described in embodiment 8-10, result is similar to the Chinese medicinal composition capsules agent effect described in embodiment 7, and the clinical effectiveness of Improving memory power is remarkable.
Above-mentioned clinical observation result shows that the pharmaceutical preparation treatment senile dementia of Chinese medicine composition of the present invention is evident in efficacy, and have no side effect, without drug dependence, drug safety, has actual clinical meaning.Therefore, Chinese medicine composition of the present invention effectively can be applied to senile dementia, evident in efficacy.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, under the premise without departing from the principles of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.

Claims (10)

1. a Chinese medicine composition, be made up of the raw material of following weight portion:
Ganoderma 4-12 part, Rhizoma Gastrodiae 2-5 part, Radix Morindae Officinalis 3-7 part, Radix Astragali 2-5 part, Radix Notoginseng 3-8 part.
2. Chinese medicine composition according to claim 1, described raw material medicines in portions by weight number is:
Ganoderma 5 parts, 2 parts, Rhizoma Gastrodiae, Radix Morindae Officinalis 3 parts, the Radix Astragali 2 parts, Radix Notoginseng 3 parts.
3. a preparation method for Chinese medicine composition, with parts by weight, gets Ganoderma 4-12 part, Rhizoma Gastrodiae 2-5 part, Radix Morindae Officinalis 3-7 part, Radix Astragali 2-5 part, Radix Notoginseng 3-8 part, ethanol extraction, filters, and collects filtrate.
4. preparation method according to claim 3, described ethanol extraction is alcohol reflux.
5. preparation method according to claim 4, described alcohol reflux is extract crude drug 1-2 time, each 60min with crude drug gross weight 5-7 50%-90% alcohol heating reflux doubly.
6. the preparation method according to claim 3-5 any one, is also included in the step that filtrate is condensed into thick paste by less than 60 DEG C.
7. preparation method according to claim 6, the relative density of described thick paste is 1.10-1.15.
8. the Chinese medicine composition that the preparation method described in claim 3-7 prepares.
9. Chinese medicine composition described in claim 1,2 or 8 improves the application in the medicine of learning and memory and treatment senile dementia in preparation.
10. a pharmaceutical preparation, be made up of Chinese medicine composition described in the claim 1,2 or 8 of effective dose and pharmaceutically acceptable adjuvant, it is tablet, granule, capsule, powder, pill or oral liquid.
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