CN103877230A - A medicine extract product used for preventing and/or treating senile dementia, a preparing method thereof, preparations thereof and applications thereof - Google Patents
A medicine extract product used for preventing and/or treating senile dementia, a preparing method thereof, preparations thereof and applications thereof Download PDFInfo
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Abstract
The invention discloses a medicine extract product used for preventing and/or treating senile dementia, a preparing method thereof, preparations thereof and applications thereof. The medicine extract product is prepared by blending following raw material medicines by weight: 400-600 parts of herba erigerontis, 400-600 parts of gaultheria cumingiana, 400-600 parts of ginkgo leaf and 100-300 parts of pseudo-ginseng, extracting with water, performing alcohol precipitation, concentrating and drying. Powder, tablets, granules, capsules, pills and injections can be prepared by adding pharmaceutically acceptable accessory materials into the medicine extract product. The applications are applications in preparation of medicines preventing and/or treating the senile dementia. Tests prove that: the medicine extract product can significantly improve cognitive ability and physical performance of senile dementia patients, effectively relive clinical symptoms caused by qi-stagnation and blood stasis of the patients, largely shorten the P300 incubation period in different parts of the patients, and reduce the LDL-C (low density lipoprotein) level and the TC (total cholesterol) level of cerebral infarction patients.
Description
Technical field
The invention belongs to Chinese drug preparation technique field, be specifically related to a kind of for preventing and/or treating drug extract of senile dementia and preparation method thereof, preparation and application.
Background technology
Senile dementia is to occur in the intelligence infringement syndrome that senilism phase and senile disordered brain function take progressive dementia as feature produce.Comprise alzheimer disease, be again Alzheimer's disease (Alzheimer disease is called for short AD) and vascular dementia (Vascular dementia is called for short VD) two classes.Wherein AD is a kind of primary central nervous system regression disease that betides middle-aged and elderly people; VD is the dementia causing because of the cerebral lesion that cerebrovascular disease causes.The cause of disease of VD relates to two aspects, i.e. cerebrovascular and risk factor.Risk factor comprises that risk factor (hypertension, hyperlipidemia, heart disease, diabetes, universality arteriosclerosis, smoking), apoplexy, patient with ischaemic leukoaraiosis pathological changes, advanced age and the schooling of cerebrovascular is low etc.
According to incompletely statistics, the ratio of suffering from severe alzheimer disease in over-65s crowd is 5%～8%, and by 80 years old, this ratio just rose to 15%～20%.China's patients with Alzheimer disease has 6,000,000 people at present, account for 1/3 of global patient's sum, annual neopathy approximately 1,800,000 people, extremely forget 105.6 ten thousand people, morbidity situation is very severe, having become modern society and caused the main cause that old people is disabled and can not live on one's own life, is one of four large diseases of serious threat senior health and fitness.
Treat up to now alzheimer disease still without good plan, if the drug main cholinergic drug, the medicine that improves cerebral blood circulation and brain cell metabolism etc. that have or be about to appear on the market on current domestic and international market, common is mainly cholinesterase inhibitor.Tacrine (trade name group can cause) is the medicine that the first is approved for senile dementia treatment, but the hepatotoxicity of this medicine is larger, now gradually not by clinical use.Donepezil (trade name aricept) is safer effective compared with tacrine, and general recommendations takes before sleeping at night, but the patient of insomnia is advised taking medicine daytime.The conventional medicine that improves cerebral blood circulation and brain cell metabolism has duxil, Dihydroergotoxine Mesylate sheet etc., duxil is almitrine (almitrine) and raubasine (Raubasine) mix preparation by a certain percentage, due to problems such as curative effects, State Food and Drug Administration announced on May 20th, 2011, duxil will be stopped in producing and selling and the use of China, and its approval documentary evidence is also cancelled.
The effect of chemical drugs is more direct, but indication conventionally can be more single, is not so good as the comprehensive adjustment capability of Chinese medicine strong.Therefore, develop a kind of Chinese medicine preparation that is suitable for preventing and/or treating senile dementia, be very important for senile dementia is clinical.
Summary of the invention
The present invention is in order to overcome the deficiencies in the prior art, it is a kind of for preventing and/or treating the drug extract of senile dementia that the first object is to provide, the second object is to provide the preparation method of said extracted thing, the 3rd object is to provide the preparation of said extracted thing, and the 4th object is to provide said extracted thing to prevent and/or treat in senile dementia and apply in preparation
The first object of the present invention is to realize like this, following crude drug by weight ratio: 400 ~ 600 parts of Herba Erigerontiss, 400 ~ 600 parts of MANSHANXIANG, 400 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng, prepare described drug extract through water extraction, precipitate with ethanol, concentrate drying operation.
As optimal technical scheme, described crude drug is pressed following weight portion proportioning: 505 ~ 600 parts of Herba Erigerontiss, 505 ~ 600 parts of MANSHANXIANG, 400 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng.Or described crude drug is pressed following weight portion proportioning: 505 ~ 600 parts of Herba Erigerontiss, 505 ~ 600 parts of MANSHANXIANG, 555 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng.
The second object of the present invention is achieved in that and comprises raw material preparation, water extraction, precipitate with ethanol, concentrate drying operation, is specially:
A, raw material are prepared: crude drug after treatment is mixed in proportion;
B, water extraction: in raw material, add the water of 2 ~ 5 times of weight ratios, soak 3 ~ 5h; Then decoct 2 ~ 4 times, decoct 1 ~ 3h at every turn, merge decoction liquor, filter;
C, precipitate with ethanol: in the decoction liquor after filtering, add ethanol, to ethanol content in decoction liquor be till 60 ~ 80%, leave standstill 20 ~ 30h, filter, reclaim ethanol;
D, concentrate drying: by the filtrate concentrate drying reclaiming after ethanol, obtain the drug extract of powdery.
The 3rd object of the present invention is achieved in that described drug extract adds pharmaceutically acceptable adjuvant to make powder, tablet, granule, capsule, pill and injection.
The 4th object of the present invention is achieved in that the described application that prevents and/or treats alzheimer disease disease drug for preventing and/or treating the drug extract of senile dementia in preparation.
The present invention adopts Herba Erigerontis, MANSHANXIANG, Folium Ginkgo, Radix Notoginseng compatibility, and wherein Herba Erigerontis, Folium Ginkgo are monarch drug, cold expelling removing toxic substances, expelling wind and removing dampness, activating collaterals to relieve pain; MANSHANXIANG is ministerial drug, has vital energy regualting and blood circulation-promoting and relaxes through the effectiveness of dredging collateral, reducing swelling and alleviating pain; Radix Notoginseng, for assistant makes, has dissipating blood stasis hemostasis, the effect of subduing swelling and relieving pain, and full side share common performance promoting flow of QI and blood, effect of dissipating blood stasis dredging collateral.For apoplexy apoplex involving the channels and collaterals, syndrome of static blood blocking collaterals.
Herba Erigerontis has another name called Herba Erigerontis, is the herb of feverfew Erigeron breviscapus (Vant.) Hand.-Mazz.; Micro-hardship, Gan Wenxin, have effect of expelling cold and relieving exterior syndrome, expelling wind and removing dampness, blood circulation promoting and blood stasis dispelling, dredge the meridian passage, anti-inflammatory analgetic.Be recorded in the earliest that " the southern regions of the Yunnan Province book on Chinese herbal medicine "---Herba Erigerontis is used for traumatic injury, there is effect of the cold expelling of delivering, anti-inflammatory analgetic.Herba Erigerontis injection, clinically except being mainly used in diseases of cardiovascular and cerebrovascular systems, also has good curative effect in the treatment of diabetes, nephropathy, cervical vertigo, Senile disease at present.
MANSHANXIANG is for being Schisandraceae Schisandraceae Schizandra (Schisandra) plant MANSHANXIANG.Acrid in the mouth, puckery, property is flat.There is the effect of invigorating blood circulation and relaxing through dredging collateral, reducing swelling and alleviating pain.
Folium Ginkgo is the blade of ginkgo, has astringing the lung, relievings asthma, the effect such as blood circulation promoting and blood stasis dispelling, pain relieving, can be used for the diseases such as cough and asthma due to lung deficiency, coronary heart diseases and angina pectoris, hyperlipidemia, to a certain extent can memory reinforcing.
Radix Notoginseng, Araliaceae herbaceos perennial, has another name called Radix Notoginseng, mountain paint, Radix Stephaniae Sinicae (Radix Stephaniae Dielsianae), Herba Wedeliae Wallichii, Panax pseudoginseng etc., sweet in the mouth, micro-hardship, warm in nature.Return Liver Channel, stomach warp; There is dissipating blood stasis hemostasis, the swollen analgesic therapy effect of pin; Cure mainly clinically to fall and flutter congestive edema, thoracic obstruction angor, lump in the abdomen, blood stasis amenorrhea, dysmenorrhea, the cloudy stomachache of the stasis of blood in puerperal, sore, carbuncle and painful swelling.
By evidence; of the present invention for preventing and/or treating the drug extract of senile dementia; can obviously improve cognitive competence, the executive capability of old dementia patients; effectively reduction of patient is due to the caused clinical symptoms of qi depression to blood stasis; as abnormal in headache as thorn, livid purple, the hypomnesis of lip onyx, sleep disorder, anxious state of mind etc.; and can obviously shorten P300 incubation period of patient's different parts, reduce cerebral infarction patient's LDL-C(low density lipoprotein, LDL), TC(T-CHOL) level.Drug extract of the present invention can be processed into various dosage forms according to pharmaceutics conventional production process, meets different dosing patient's needs, has onset rapid, and curative effect is outstanding, has no side effect, feature easy to use.
Accompanying drawing explanation
The process flow diagram of Fig. 1 drug extract preparation method of the present invention.
The specific embodiment
Below in conjunction with drawings and Examples, the present invention is further illustrated, but never in any form the present invention is limited, and any conversion or the replacement done based on training centre of the present invention, all belong to protection scope of the present invention.
Following crude drug by weight ratio of the present invention: 400 ~ 600 parts of Herba Erigerontiss, 400 ~ 600 parts of MANSHANXIANG, 400 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng, will prepare described drug extract through water extraction, precipitate with ethanol, concentrate drying operation.
As preferential embodiment: described crude drug is by following weight portion proportioning: 505 ~ 600 parts of Herba Erigerontiss, 505 ~ 600 parts of MANSHANXIANG, 400 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng.
Described crude drug is pressed following weight portion proportioning: 505 ~ 600 parts of Herba Erigerontiss, 505 ~ 600 parts of MANSHANXIANG, 555 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng.
Of the present inventionly comprise raw material preparation, water extraction, precipitate with ethanol, concentrate drying operation for preventing and/or treating the preparation method of drug extract of senile dementia, be specially:
A, raw material are prepared: crude drug after treatment is mixed in proportion;
B, water extraction: in raw material, add the water of 2 ~ 5 times of weight ratios, soak 3 ~ 5h; Then decoct 2 ~ 4 times, decoct 1 ~ 3h at every turn, merge decoction liquor, filter;
C, precipitate with ethanol: in the decoction liquor after filtering, add ethanol, to ethanol content in decoction liquor be till 60 ~ 80%, leave standstill 20 ~ 30h, filter, reclaim ethanol;
D, concentrate drying: by the filtrate concentrate drying reclaiming after ethanol, obtain the drug extract of powdery.
Immersion described in B step is the water that adds 3 ~ 4 times of weight ratios, and temperature is 10 ~ 30 ℃, described bag type filtering, plate-and-frame filtration or the screen filtration of being filtered into.
In C step, adding ethanol to ethanol content in decoction liquor is till 70%, leaves standstill 24h; The described membrane filtration that is filtered into, filter membrane aperture is 0.2 ~ 15 μ m.Recovery ethanol described in C step is to reclaim or embrane method recovery by thermal evaporation.
Concentrate drying described in D step is constant pressure and dry or drying under reduced pressure, takes that spraying is dry, one or more combination in lyophilization, microwave drying, forced air drying, hygroscopic desiccation.
Of the present invention for preventing and/or treating the preparation of drug extract of senile dementia, be to add pharmaceutically acceptable adjuvant to make powder, tablet, granule, capsule, pill and injection at described drug extract.
The application that prevents and/or treats alzheimer disease disease drug for preventing and/or treating the drug extract of senile dementia in preparation of the present invention.
Embodiment 1
Get Herba Erigerontis 60kg after treatment, MANSHANXIANG 40kg, Folium Ginkgo 60kg, Radix Notoginseng 10kg mixing; Add the water of 340kg, at 10 ℃, soak 5h; Then decoct 4 times, decoct 3h at every turn, merge decoction liquor, filter with filter bag; In the decoction liquor after filtering, add ethanol, to ethanol content in decoction liquor be till 60%, leave standstill 30h, with membrane filtration, thermal evaporation reclaims ethanol; By the filtrate microwave drying and the hygroscopic desiccation combination drying under normal pressure operating mode that reclaim after ethanol, obtain the drug extract of powdery.
Embodiment 2
Get Herba Erigerontis 50.5kg after treatment, MANSHANXIANG 50.5kg, Folium Ginkgo 555kg, Radix Notoginseng 20kg mixing; Add the water of 530kg, at 30 ℃, soak 3h; Then decoct 3 times, decoct 2h at every turn, merge decoction liquor, filter with filter bag; In the decoction liquor after filtering, add ethanol, to ethanol content in decoction liquor be till 70%, leave standstill 24h, with the membrane filtration of 0.45 ~ 15 μ m, embrane method recovery ethanol; By the filtrate microwave drying under normal pressure operating mode reclaiming after ethanol, obtain the drug extract of powdery.
Embodiment 3
Get Herba Erigerontis 40kg after treatment, MANSHANXIANG 60kg, Folium Ginkgo 40kg, Radix Notoginseng 30kg mixing; Add the water of 850kg, at 25 ℃, soak 4h; Then decoct 4 times, decoct 2h at every turn, merge decoction liquor, with the filter bag filtration of 0.3 μ m; In the decoction liquor after filtering, add ethanol, to ethanol content in decoction liquor be till 80%, leave standstill 20h, filter thermal evaporation recovery ethanol with the mixed cellulose ester microporous membrane of 0.45 ~ 1.2 μ m; By filtrate lyophilization under decompression operating mode of reclaiming after ethanol, obtain the drug extract of powdery.
Embodiment 4
Get Herba Erigerontis 50kg after treatment, MANSHANXIANG 50kg, Folium Ginkgo 50kg, Radix Notoginseng 20kg mixing; Add the water of 680kg, at 20 ℃, soak 4h; Then decoct 3 times, decoct 2h at every turn, merge decoction liquor, with the filter bag filtration of 0.4 μ m; In the decoction liquor after filtering, add ethanol, to ethanol content in decoction liquor be till 70%, leave standstill 24h, with the polyvinylidene fluoride film membrane filtration of 0.2 ~ 0.45 μ m, thermal evaporation recovery ethanol; Filtrate after recovery ethanol is sprayed under normal pressure operating mode dry, obtained the drug extract of powdery.
Embodiment 5
Get drug extract prepared by embodiment 1, powder is made in pack.
Embodiment 6
Get drug extract prepared by embodiment 2, add pharmaceutically acceptable adjuvant to make tablet.
Embodiment 7
Get drug extract prepared by embodiment 3, add pharmaceutically acceptable adjuvant to make capsule.
Embodiment 8
Get drug extract prepared by embodiment 4, add pharmaceutically acceptable adjuvant granulation agent.
Embodiment 9
Get drug extract prepared by embodiment 2, add pharmaceutically acceptable adjuvant to make loose pill.
Embodiment 10
Get drug extract prepared by embodiment 4, add pharmaceutically acceptable adjuvant to make injection.
Embodiment 11
The capsule that the drug extract of preparing with embodiment 3 is prepared through embodiment 7 carries out clinical observation on the therapeutic effect test.Adopt the method for standard drug parallel control, randomized, double-blind, dual analog, the clinical research of single center.Test group 36 examples are set, and oral 2 tablets/time, 3 times/day, experimental period is 90 ± 7 days; Matched group 36 examples, oral Dihydroergotoxine Mesylate sheet, each 2mg/ sheet, 3 times/day, experimental period is 90 ± 7 days.
Clinical test results and analysis:
1, MMSE, MoCA, ADL-R quantize grade form relatively in table 1, table 2, table 3, table 4, table 5
Table 1: compare in treatment MMSE, MoCA, ADL-R front and that treat 6 weeks organize
Table 1 shows: MMSE (mini-mental state examination, MMSE simple intelligent mental status examination method), the cognitive assessment in MoCA(Montreal Montreal cognitive assessment when two groups of patient treatments 6 weeks, MoCA
), ADL-R(daily life active ability activity of daily living scale) scale scoring compared with before treatment, all have significant difference (
p<0.01).Prompting: two kinds of Drug therapy dementia syndrome of qi stagnation and blood stasis first meeting curative effect in the time taking 6 weeks.
Table 2: compare in treatment MMSE, MoCA, ADL-R front and that treat 12 weeks organize
Table 2 shows: MMSE, MoCA when two groups of patient treatments 12 weeks, the scoring of ADL-R scale compared with before treatment, all have significant difference (
p<0.01).
Table 3: treat and organize relatively interior with treatment MMSE, the MoCA of 12 weeks, ADL-R in 6 weeks
Table 3 shows: compared with when MMSE, MoCA when two groups of patient treatments 12 weeks, the scoring of ADL-R scale and treatment 6 weeks, all have significant difference (
p<0.01).Prompting: two kinds of medicines in improvement group aspect patient's cognitive function, the curative effect when curative effect while taking 12 weeks is better than taking 6 weeks.
Table 4: compare between treatment group and the treatment of control group MMSE of 6 weeks, MoCA, ADL-R group
| Project | Treatment group 6 weeks (n=36) | Matched group 6 weeks (n=36) | Average difference | t | P |
| MMSE | 24.64±2.06 | 24.56±1.98 | 0.083 | 0.175 | 0.861 |
| MOCA | 22.94±1.93 | 23.11±1.97 | -0.167 | 0.363 | 0.718 |
| ADL-R | 24.78±3.93 | 24.86±3.91 | -0.083 | 0.090 | 0.928 |
Table 4 shows: two groups of patients took medicine after 6 weeks, treatment group compared with matched group, MMSE, MoCA, ADL-R scale mark equal no difference of science of statistics (
p>0.05).Prompting: two groups of drug administrations are after 6 weeks, is improving therapeutic equivalence aspect cognitive function of patients.
Table 5: compare between treatment group and the treatment of control group MMSE of 12 weeks, MoCA, ADL-R group
| Project | Treatment group 12 weeks (n=36) | Matched group 12 weeks (n=36) | Average difference | t | P |
| MMSE | 25.89±1.60 | 25.72±1.56 | 0.167 | 0.447 | 0.656 |
| MOCA | 23.97±1.46 | 24.06±1.74 | -0.083 | 0.220 | 0.827 |
| ADL-R | 24.25±3.95 | 24.19±3.89 | 0.056 | 0.060 | 0.952 |
Table 5 shows: two groups of patients took medicine after 12 weeks, treatment group compared with matched group, MMSE, MoCA, ADL-R scale mark equal no difference of science of statistics (
p>0.05).Prompting: two groups of drug administrations are after 12 weeks, is improving therapeutic equivalence aspect cognitive function of patients.
2, P
300curative effect is relatively in table 6, table 7, table 8, table 9, table 10
Table 6: the front P with treating 6 weeks for the treatment of
300in group, compare
Table 6 shows: P when two groups of patient treatments 6 weeks
300numerical value with treatment before compared with, all have significant difference (
p<0.05).Prompting: two kinds of medicines all can improve brain function, first meeting curative effect in the time treating 6 weeks.
Table 7: the front P with treating 12 weeks for the treatment of
300in group, compare
Table 7 shows: P when two groups of patient treatments 12 weeks
300numerical value with treatment before compared with, all have significant difference (
p<0.05).
Table 8: treat 6 weeks with the treatment P of 12 weeks
300in group, compare
Table 8 shows: the numerical value at treatment group treatment top (CZ) after 12 weeks has been compared notable difference (p<0.05), forehead (FZ), occipitalia (PZ) numerical value no significant difference (P>0.05) when treating 6 weeks; Notable difference (p<0.05), the numerical value no significant difference (P>0.05) of top (CZ) when the numerical value of forehead (FZ), occipitalia (PZ) was with treatment 6 weeks after treatment of control group 12 weeks, are compared.Prompting: test group medicine is effective for improving brain top function.
Table 9: treatment group and the treatment of control group P of 6 weeks
300between group, compare
| Project | Treatment group 6 weeks (n=36) | Matched group 6 weeks (n=36) | Average difference | t | P |
| Forehead | 352.31±44.73 | 365.56±38.05 | -13.250 | 1.354 | 0.180 |
| Top | 355.86±39.48 | 358.36±41.46 | -2.500 | 0.262 | 0.794 |
| Occipitalia | 357.67±48.33 | 367.00±41.62 | -9.333 | 0.878 | 0.383 |
Table 9 shows: two groups of patient treatments are after 6 weeks, treatment group compared with matched group, P
300each position numerical value no difference of science of statistics (
p>0.05).Prompting: while treating 6 weeks, two groups of medicines are improving brain in patients function aspects therapeutic equivalence.
Table 10: treatment group and the treatment of control group P of 12 weeks
300between group, compare
| Project | Treatment group 12 weeks (n=36) | Matched group 12 weeks (n=36) | Average difference | t | P |
| Forehead | 350.17±56.98 | 350.50±33.81 | -0.333 | 0.030 | 0.976 |
| Top | 346.28±45.00 | 355.92±35.42 | -9.639 | 1.010 | 0.316 |
| Occipitalia | 349.39±40.34 | 356.72±37.61 | -7.333 | 0.798 | 0.428 |
Table 10 shows: two groups of patient treatments are after 12 weeks, treatment group compared with matched group, P
300each position numerical value no difference of science of statistics (
p>0.05).Prompting: treat after 12 weeks, two groups of medicines are improving brain in patients function aspects therapeutic equivalence.
3, LDL-C result is relatively in table 11
Table 11: treat in front and the treatment LDL-C of 12 weeks group and compare between group
Table 11 shows: two groups of patient treatments LDL-C(low density lipoprotein, LDL after 12 weeks) numerical value compared with before treatment, treatment group have significant difference (
p<0.01); Matched group no difference of science of statistics (
p>0.05).Treat after 12 weeks, treatment group compared with matched group, LDL-C numerical value no difference of science of statistics (
p>0.05).Prompting: test group medicine can improvement group in patient's LDL-C level.
4, tcm syndrome integration and curative effect are relatively in table 12, table 13, table 14, table 15, table 16, table 17
Table 12: relatively interior with the treatment tcm syndrome integration group of 6 weeks before treatment
Table 12 shows: tcm syndrome integration when two groups of patient treatments 6 weeks compared with before treatment, all have significant difference (
p<0.01).Prompting: two kinds of medicines are in the time taking 6 weeks, for the tcm clinical practice syndrome first meeting curative effect of patient in improvement group.
Table 13: relatively interior with the treatment tcm syndrome integration group of 12 weeks before treatment
Table 13 shows: tcm syndrome integration when two groups of patient treatments 12 weeks compared with before treatment, all have significant difference (
p<0.01).Prompting: two kinds of medicines were taken after 12 weeks, patient's tcm clinical practice syndrome in obviously improvement group.
Table 14: treat and compare with the treatment tcm syndrome integration group of 12 weeks is interior for 6 weeks
Table 14 shows: compared with when tcm syndrome integration when two groups of patient treatments 12 weeks and treatment 6 weeks, all have significant difference (
p<0.01).Prompting: two kinds of medicines are improving aspect tcm syndrome, the curative effect when curative effect while taking 12 weeks is better than taking 6 weeks.
Table 15: compare between treatment group and the matched group tcm syndrome integration group of 6 weeks
| Project | Treatment group 6 weeks | Matched group 6 weeks | Average difference | t | P |
| Tcm syndrome integration | 9.64±3.15 | 10.69±3.85 | -1.056 | 1.275 | 0.207 |
Table 15 shows: treatment group compared with matched group, the tcm syndrome integral contrast no difference of science of statistics 6 weeks time of taking medicine (
p>0.05).Prompting: take medicine after 6 weeks, two kinds of medicines are improving therapeutic equivalence aspect tcm syndrome.
Table 16: compare between treatment group and the matched group tcm syndrome integration group of 12 weeks
| Project | Treatment group 12 weeks | Matched group 12 weeks | Average difference | t | P |
| Tcm syndrome integration | 7.19±3.71 | 9.31±4.82 | -2.111 | 2.082 | 0.041 |
Table 16 shows: treatment group compared with matched group, the tcm syndrome integral contrast of taking medicine after 12 weeks have significant difference (
p<0.05).Prompting: take medicine after 12 weeks, test group medicine is better than Dihydroergotoxine Mesylate sheet improving aspect tcm syndrome.
Table 17: compare between the group of tcm syndrome curative effect
Table 17 shows: the tcm syndrome curative effect for the treatment of group and matched group is distributed and forms (effective percentage) and compare, its result have significant difference (
p<0.01).Prompting: test group medicine is improving aspect tcm syndrome, and curative effect is better than Dihydroergotoxine Mesylate sheet.
5, safety evaluatio is in table 18, table 19
Table 18: blood cell analysis index comparison
Table 19: blood biochemical analysis index comparison
Table 18,19 shows: blood cell analysis data after 12 weeks of two groups of patient treatments and blood biochemical analytical data are compared with before treatment, the TC numerical value for the treatment of group has significant difference (P<0.05), the more equal no difference of science of statistics of all the other every data (P>0.05) compared with before treatment.
At duration of test, the toxicity of the medicine that two groups of patients are taken is observed simultaneously, and treatment group has 1 routine patient to occur dizziness, because of symptom very slight, therefore do not discontinue medication, cause due to hypertension by proving because missing depressor, irrelevant with medicine for treatment; Matched group patient has no obvious adverse effect at the viewing duration of taking medicine.
Conclusion: test group medicine is treated senile dementia clinical observation through clinical trial and confirmed, test group Drug therapy senile dementia significant effective can strengthen patient's cognitive competence and improve patient's clinical symptoms, has no obvious side reaction and occurs.Therefore, test group medicine can, for prevention and treatment senile dementia, be a kind of compound Chinese medicinal preparation safe, evident in efficacy, clinic application.
Embodiment 12
Powder, tablet, granule with embodiment 5,6,8 preparations have carried out respectively the test of embodiment 11, and its result of the test is very approaching, all can prove that drug extract prepared by the present invention can be for prevention and treatment senile dementia.
Claims (10)
1. one kind for preventing and/or treating the drug extract of senile dementia, it is characterized in that following crude drug by weight ratio: 400 ~ 600 parts of Herba Erigerontiss, 400 ~ 600 parts of MANSHANXIANG, 400 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng, prepare described drug extract through water extraction, precipitate with ethanol, concentrate drying operation.
2. according to claim 1 for preventing and/or treating the drug extract of senile dementia, it is characterized in that described crude drug is by following weight portion proportioning: 505 ~ 600 parts of Herba Erigerontiss, 505 ~ 600 parts of MANSHANXIANG, 400 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng.
3. according to claim 1 for preventing and/or treating the drug extract of senile dementia, it is characterized in that described crude drug is by following weight portion proportioning: 505 ~ 600 parts of Herba Erigerontiss, 505 ~ 600 parts of MANSHANXIANG, 555 ~ 600 parts of Folium Ginkgos, 100 ~ 300 parts of Radix Notoginseng.
4. a method of preparing described in claim 1,2 or 3 drug extract for preventing and/or treating senile dementia, is characterized in that comprising raw material preparation, water extraction, precipitate with ethanol, concentrate drying operation, is specially:
A, raw material are prepared: crude drug after treatment is mixed in proportion;
B, water extraction: in raw material, add the water of 2 ~ 5 times of weight ratios, soak 3 ~ 5h; Then decoct 2 ~ 4 times, decoct 1 ~ 3h at every turn, merge decoction liquor, filter;
C, precipitate with ethanol: in the decoction liquor after filtering, add ethanol, to ethanol content in decoction liquor be till 60 ~ 80%, leave standstill 20 ~ 30h, filter, reclaim ethanol;
D, concentrate drying: by the filtrate concentrate drying reclaiming after ethanol, obtain the drug extract of powdery.
5. preparation method according to claim 4, is characterized in that the immersion described in B step is the water that adds 3 ~ 4 times of weight ratios, and temperature is 10 ~ 30 ℃, described bag type filtering, plate-and-frame filtration or the screen filtration of being filtered into.
6. preparation method according to claim 4, it is characterized in that adding in C step ethanol to ethanol content in decoction liquor is till 70%, leaves standstill 24h; The described membrane filtration that is filtered into, filter membrane aperture is 0.2 ~ 15 μ m.
7. preparation method according to claim 4, is characterized in that: the recovery ethanol described in C step is to reclaim or embrane method recovery by thermal evaporation.
8. preparation method according to claim 4, is characterized in that: the concentrate drying described in D step is constant pressure and dry or drying under reduced pressure, takes that spraying is dry, one or more combination in lyophilization, microwave drying, forced air drying, hygroscopic desiccation.
9. a preparation for drug extract described in claim 1,2 or 3, is characterized in that: described drug extract adds pharmaceutically acceptable adjuvant to make powder, tablet, granule, capsule, pill and injection.
10. described in a claim 1,2 or 3, drug extract prevents and/or treats the application in alzheimer disease disease drug in preparation.
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| CN201210561380.7A CN103877230A (en) | 2012-12-21 | 2012-12-21 | A medicine extract product used for preventing and/or treating senile dementia, a preparing method thereof, preparations thereof and applications thereof |
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| CN201210561380.7A CN103877230A (en) | 2012-12-21 | 2012-12-21 | A medicine extract product used for preventing and/or treating senile dementia, a preparing method thereof, preparations thereof and applications thereof |
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| CN201210561380.7A Pending CN103877230A (en) | 2012-12-21 | 2012-12-21 | A medicine extract product used for preventing and/or treating senile dementia, a preparing method thereof, preparations thereof and applications thereof |
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| CN (1) | CN103877230A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105963568A (en) * | 2016-07-04 | 2016-09-28 | 青岛贝瑞康生物科技有限公司 | Medicine for treating Alzheimer's disease and preparation method thereof |
| CN114470061A (en) * | 2020-10-23 | 2022-05-13 | 昆药集团股份有限公司 | New extraction process of 'Dingyinnaotong' pharmaceutical composition and new applicable crowd thereof |
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| CN1317331A (en) * | 2000-04-08 | 2001-10-17 | 昆明制药股份有限公司 | Chinese medicine for treating cerebral arteriosclerosis and its preparing process |
| CN1651008A (en) * | 2004-12-27 | 2005-08-10 | 张自超 | Chinese medicine for treating blood vessel nature feeble-mindedness |
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| CN1317331A (en) * | 2000-04-08 | 2001-10-17 | 昆明制药股份有限公司 | Chinese medicine for treating cerebral arteriosclerosis and its preparing process |
| CN1768772A (en) * | 2004-10-15 | 2006-05-10 | 贵阳云岩西创药物科技开发有限公司 | Compound formulation of breviscapine for treating cardiovascular and cerebrovascular diseases. its preparing process and application |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105963568A (en) * | 2016-07-04 | 2016-09-28 | 青岛贝瑞康生物科技有限公司 | Medicine for treating Alzheimer's disease and preparation method thereof |
| CN114470061A (en) * | 2020-10-23 | 2022-05-13 | 昆药集团股份有限公司 | New extraction process of 'Dingyinnaotong' pharmaceutical composition and new applicable crowd thereof |
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