CN104288370A - Novel medicinal application of Sailuotong capsule - Google Patents
Novel medicinal application of Sailuotong capsule Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
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- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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Abstract
The invention relates to a novel medicinal application of a known traditional Chinese medicine composition, and particularly relates to application of a known traditional Chinese medicine composition in preparation of a medicine for preventing and treating depression. Experiments prove that the traditional Chinese medicine composition has a remarkable curative effect on anti-depression, is quick in response and small in toxic and side effect, and is a safe anti-depression medicine. In the prior art, the traditional Chinese medicine composition is developed and prepared into a Sailuotong capsule for treating ischemic cerebrovascular diseases, vascular dementia and senile dementia diseases, while a novel medicinal application is provided to the Sailuotong capsule.
Description
Technical field
The present invention relates to the new medical usage of Chinese medicine composition, particularly relate to the purposes of a kind of Chinese medicine composition in preparation treatment or prevention of depression medicine.
Background technology
Depression is a kind of to continue the depressed spiritual feelings will obstacle disease for cardinal symptom, and having the advantages that prevalence is high, relapse rate is high, homicide rate is high, is one of global public health problem, is subject to the extensive attention of international community and countries in the world.This disease occupies second in China's disease financial burden rank, is 6.2%.The core symptom of depression comprises: depressive mood, hebetude, sense of guilt and valueless sense, sleep disordered and appetite decline, movablely reduce, aprosexia and suicidal idea etc.The quickening of China along with modern life rhythm and the aggravation of social competition, the prevalence of mental sickness is in ascendant trend year by year.China's depression rate is 3-5%, existing suffer from depression more than 2,600 ten thousand people, direct and the indirect economic loss caused every year reaches 8,000,000,000 dollars, in 3.4 hundred million children and adolescents of less than 17 years old, about has 3,000 ten thousand people to be subject to the puzzlement of emotion and psychological problems.A joint study of World Health Organization (WHO), the World Bank and Ha Fu university shows, depression has become the second largest disease of Chinese Disease Spectrum.According to World Health Organization's statistics, the incidence rate of whole world depression is 3.1%, in developed country close to 6%, there is depressive illness patient about 3.4 in the whole world, become the fourth-largest illness in the world, expected the year two thousand twenty, depression is only second to the second largest disease of cardiovascular and cerebrovascular disease by becoming.Depression seriously annoyings normal work, the studying and living of people, brings white elephant to patient home and society, and its high homicide rate tendency also directly affects social stability.
Main and the biochemical factor of the morbidity of depression, inherited genetic factors, society is relevant with the factor such as environment, its pathogenesis is still not fully aware of, nervus centralis norepinephrine (NE) in brain, 5-hydroxy tryptamine (5-HT), the neurotransmitter regulator such as dopamine (DA) reduce and corresponding receptor hypo-function, cerebral hippocampus regional neuronal occurs to reduce or atrophy, neuroglia density lowers and prefrontal cortex neuron volume reduces, and hypothalmus-pituitary-adrenal axis (HPA) imbalance, Brain Derived Neurotrophic Factor (BDNF) is expressed and is declined, all may cause the generation of depression.The antidepressant drug of current Clinical practice mainly comprises heterocyclic antidepressants (TCAs), oxidase inhibitor (MAOIs), NE reuptake inhibitor (SNRIs), selectivity 5-HT reuptake inhibitor (SSRIs), non-selective reuptake inhibitor (NSRIs), dopamine and norepinephrine reuptake inhibitor (DNRIs), 5-HT receptor modulators (SRMs) and other antidepressants such as three ring Fourth Rings as types such as tianeptines.These antidepressants are mainly based on the chemical synthetic drug of monoamine hypothesis, and long-term taking there will be serious toxic and side effects, also have that narrow, the onset of antidepressant spectrum is slow, remission not thoroughly, the easy shortcoming such as recurrence.As the TACs such as imipramine, amitriptyline can cause, patient's retina is fuzzy, platycoria, dysuria, abnormal liver function, agranulocytosis etc., and with central nervous system toxicity and cardiovascular system toxicity; The selectivity such as Iproniazid, cyclopropylamine MAOIs can cause nausea, have a sleepless night, the untoward reaction such as postural hypotension, edema; The representative medicine venlafaxine of SNRIs cause manic may, often with feeling sick, xerostomia, weak, anxiety, to tremble and sexual impotence etc.And the Chinese medicine knowledge of natural environment that is people in long term medical practice utilize natural product, action temperature and, few side effects, therefore, in the manufacture and exploit of antidepressant drug, pay attention to conventional medicament and natural drug gradually both at home and abroad.
The patent No. is the compositions that ZL02131435.7 patent of invention provides the Chinese medicines such as a kind of Radix Ginseng, Folium Ginkgo and Stigma Croci containing treatment effective dose, is used for the treatment of ischemic cerebrovascular and vascular dementia, senile dementia etc.Applicant have developed " plug ruton capsules " (its initial trade name is weinakang) and is in clinical stage at present based on this patent.In development, applicant finds that said composition also has good antidepressant effect, and this effect not yet has open report at present.
Summary of the invention
The object of the present invention is to provide the purposes of a kind of Chinese medicine composition be made up of Radix Ginseng, Folium Ginkgo, Stigma Croci in preparation treatment or prevention of depression medicine.Second object of the present invention is in the purposes providing a kind of Chinese medicine composition be made up of Radix Ginseng, Folium Ginkgo, Stigma Croci, Radix Salviae Miltiorrhizae in preparation treatment or prevention of depression medicine.
A technical scheme of the present invention: by the Chinese medicine composition that is made up of Radix Ginseng, Folium Ginkgo, Stigma Croci for the preparation of in the medicine for the treatment of or prevention of depression.
Described Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 10-150 part, Folium Ginkgo 10-200 part and Stigma Croci 0.1-50 part, above number is weight portion.
Preferred Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 20-100 part, Folium Ginkgo 20-150 part and Stigma Croci 0.1-40 part, above number is weight portion.
Preferred Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 30-50 part, Folium Ginkgo 30-120 part and Stigma Croci 0.4-10 part, above number is weight portion.
Most preferred Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 40 parts, Folium Ginkgo 60 parts and Stigma Croci 5 parts, above number is weight portion.
Another technical scheme of the present invention: by the Chinese medicine composition that is made up of Radix Ginseng, Folium Ginkgo, Stigma Croci, Radix Salviae Miltiorrhizae for the preparation of in the medicine for the treatment of or prevention of depression.
Described Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 10-150 part, Folium Ginkgo 10-200 part and Stigma Croci 0.1-50 part, and Radix Salviae Miltiorrhizae 10-50 part (preferred 15-30 part), above number is weight portion.
Preferred Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 20-100 part, Folium Ginkgo 20-150 part and Stigma Croci 0.1-40 part, and Radix Salviae Miltiorrhizae 10-50 part (preferred 15-30 part), above number is weight portion.
Preferred Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 30-50 part, Folium Ginkgo 30-120 part and Stigma Croci 0.4-10 part, and Radix Salviae Miltiorrhizae 10-50 part (preferred 15-30 part), above number is weight portion.
Further preferred Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 40 parts, Folium Ginkgo 60 parts and Stigma Croci 5 parts, Radix Salviae Miltiorrhizae 10-50 part (preferred 15-30 part), above number is weight portion.
In second technical scheme, most preferred Chinese medicine composition is prepared from by the raw material of following weight portion: Radix Ginseng 80 parts, Folium Ginkgo 100 parts and Stigma Croci 4 parts, Radix Salviae Miltiorrhizae 10, above number is weight portion.
In addition, the compositions described in above-mentioned two kinds of technical schemes can be prepared into liquid preparation, solid and semi-solid preparation, gaseous formulation with the pharmaceutically acceptable adjuvant of at least one.Described liquid preparation comprises oral liquid, suspension, syrup, injection, medicated wine, tincture, described solid and semi-solid preparation comprise tablet, pill, unguentum, sublimed preparation, powder, granule, suppository, powder, Emulsion, masticatory and capsule, and described gaseous formulation comprises aerosol and inhalant.
Finally, the compositions described in technique scheme most preferably dosage form is capsule.
Chinese medicine composition described in technique scheme and the preparation method of relative medicine are: take various crude drug in proportion, and its preparation process is the specific embodiment method of ZL02131435.7 patent of invention see the patent No..
Compared with prior art, tool of the present invention has the following advantages:
(1) present invention finds the new medical usage of known Chinese medicine composition, use it for depression, and treatment or the medicine of prevention of depression or health food can be prepared, thus the new field that has been the application extension of this Chinese medicine composition.
(2) Chinese medicine composition of the present invention and corresponding pharmaceutical dosage form thereof, adopt different animal models, a large amount of zooperies has been carried out by oral injecting pathway, experimental result shows: a. Chinese medicine composition of the present invention significantly can shorten mouse tail suspension dead time and forced swimming dead time, and obviously in dose-effect relationship; B. the temperature decline of reserpine induction can significantly be reduced; C. significantly can suppress the weight loss of chronic stress depression rat, to the decline of sugar consumption amount, significantly reduce depression rat diving tower errors number, significantly increase the score that rat opens the horizontal and vertical motion of case activity; D. significantly can increase monoamine neurotransmitter norepinephrine, the 5-hydroxy tryptamine content in depression rat brain, show that Chinese medicine composition of the present invention has stronger antidepressant effect.
Chinese medicine composition toxic and side effects of the present invention is little, security performance good, can long-term taking, there is good prospect in medicine.
Specific embodiments
Following is in conjunction with specific embodiments and experimental example, sets forth the present invention further.But these embodiments and experimental example are only limitted to the present invention instead of for limiting the scope of the invention is described.The experimental technique of unreceipted specific experiment condition in the following example and experimental example, usually conveniently condition, or according to the condition that manufacturer advises.
Part I: the preparation of Chinese medicine composition and preparation thereof
Embodiment 1
Chinese medicine composition:
Radix Ginseng 10 parts
Folium Ginkgo 10 parts
Stigma Croci 0.1 part
Its corresponding preparations preparation method: extract by method disclosed in patent of invention ZL02131435.7 embodiment 1, and be prepared into granule, capsule, injection respectively in a conventional way.
Embodiment 2
Chinese medicine composition:
Radix Ginseng 10 parts
Folium Ginkgo 200 parts
Stigma Croci 50 parts
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 3
Chinese medicine composition:
Radix Ginseng 150 parts
Folium Ginkgo 10 parts
Stigma Croci 0.1 part
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 4
Chinese medicine composition:
Radix Ginseng 150 parts
Folium Ginkgo 10 parts
Stigma Croci 50 parts
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 5
Chinese medicine composition:
Radix Ginseng 20 parts
Folium Ginkgo 20 parts
Stigma Croci 0.1 part
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 6
Chinese medicine composition:
Radix Ginseng 20 parts
Folium Ginkgo 150 parts
Stigma Croci 40 parts
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 7
Chinese medicine composition:
Radix Ginseng 100 parts
Folium Ginkgo 20 parts
Stigma Croci 0.1 part
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 8
Chinese medicine composition:
Radix Ginseng 100 parts
Folium Ginkgo 150 parts
Stigma Croci 0.1 part
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 9
Chinese medicine composition:
Radix Ginseng 30 parts
Folium Ginkgo 30 parts
Stigma Croci 0.4 part
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 10
Chinese medicine composition:
Radix Ginseng 30 parts
Folium Ginkgo 120 parts
Stigma Croci 10 parts
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 11
Chinese medicine composition:
Radix Ginseng 50 parts
Folium Ginkgo 30 parts
Stigma Croci 0.4 part
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 12
Chinese medicine composition:
Radix Ginseng 50 parts
Folium Ginkgo 120 parts
Stigma Croci 10 parts
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 13
Chinese medicine composition:
Radix Ginseng 40 parts
Folium Ginkgo 60 parts
Stigma Croci 5 parts
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 14
Chinese medicine composition:
Its corresponding preparations preparation method: extract by method disclosed in patent of invention ZL02131435.7 embodiment 4, and be prepared into granule, capsule, injection respectively in a conventional way.
Embodiment 15
Chinese medicine composition:
Its corresponding preparations is by method preparation described in the embodiment of the present invention 14.
Embodiment 16
Chinese medicine composition:
Its corresponding preparations is by method preparation described in the embodiment of the present invention 14.
Embodiment 17
Chinese medicine composition:
Its corresponding preparations is by method preparation described in the embodiment of the present invention 14.
Embodiment 18
Chinese medicine composition:
Its corresponding preparations is by method preparation described in the embodiment of the present invention 14.
Embodiment 19
Chinese medicine composition:
Radix Ginseng 150 parts
Folium Ginkgo 200 parts
Stigma Croci 50 parts
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 20
Chinese medicine composition:
Radix Ginseng 100 parts
Folium Ginkgo 150 parts
Stigma Croci 40 parts
Its corresponding preparations is by method preparation described in the embodiment of the present invention 1.
Embodiment 21
Chinese medicine composition:
Its corresponding preparations is by method preparation described in the embodiment of the present invention 14.
Embodiment 22
Chinese medicine composition:
Its corresponding preparations is by method preparation described in the embodiment of the present invention 14.
Part II pharmacodynamic experiment
Test example 1 Chinese medicine composition gastric infusion of the present invention is on the impact of Tail suspension test
1. experiment material
ICR mice, male, body weight 18 ~ 20g, is provided by dimension tonneau China animal experimental center.
Chinese medicine composition of the present invention (self-control is prepared into corresponding preparation by the method described in various embodiments of the present invention before using); Positive drug: fluoxetine hydrochloride capsules (fluoxetine hydrochloride capsules), Xin Gang pharmaceutical factory of Shanghai Westen and Chinese Tranditional Medicine Pharamacentic Co., Ltd.
JZ type 300g tonotransducer (Gaobeidian City newly navigate accumulation equipment company limited), Medlab System of organism signal (Nanjing is easily beautiful).
2. test method and result
Normal mouse is divided into 17 groups at random by body weight, often organize 20, i.e. model group, positive drug fluoxetine hydrochloride capsules (0.0035g/kg/d), embodiment 1 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 10 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 14 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 18 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 21 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group.Each group all by 0.2mL/10g body weight gastric infusion, successive administration 2 days.
After the 2nd day administration 1h, use immobilization with adhesive tape on the line of 100g tonotransducer mice tail end (apart from tail point 2cm place), it is made to be the state of hanging by the feet, head separating test platform is about 15cm, tests 2 animals at every turn simultaneously, separates each other with cardboard.Transducer is connected to Medlab System of organism signal, and after adapting to 2min, the result within record 6min, is converted into the time (s) by motionless state.
Experimental data is used
represent, experimental result SPSS11.5 statistical software (purchased from American SPSS Inc.) carries out variance analysis.Experimental result is in table 1.
Table 1 gastric infusion Chinese medicine composition of the present invention on the impact of mouse tail suspension dead time (
)
Note: compared with model group
*p<0.05;
*p<0.01
Experimental result shows: gastric infusion Chinese medicine composition of the present invention object height, middle dosage group all significantly can shorten the mouse tail suspension dead time and (compare with model group, P<0.01, P<0.05), and in obvious dose-effect relationship, point out Chinese medicine composition of the present invention to have good antidepressant function.
Test example 2 Chinese medicine composition gastric infusion of the present invention is on the impact of Mouse Forced Swim Test
1. experiment material
ICR mice, male, body weight 18 ~ 20g, is provided by dimension tonneau China animal experimental center.
Chinese medicine composition of the present invention (self-control is prepared into corresponding preparation by the method described in various embodiments of the present invention before using); Positive drug: fluoxetine hydrochloride capsules (fluoxetine hydrochloride capsules), Xin Gang pharmaceutical factory of Shanghai Westen and Chinese Tranditional Medicine Pharamacentic Co., Ltd.
Thermometer, stopwatch, glass jar, Plato's digital camera head, notebook computer.
2. experimental technique
Normal mouse is divided into 17 groups at random by body weight, often organize 20, i.e. model group, positive drug fluoxetine hydrochloride capsules (0.0035g/kg/d), embodiment 1 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 10 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 14 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 18 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 21 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group.Each group all by 0.2mL/10g body weight gastric infusion, successive administration 2 days, blank group is to deionized water.
By single for the mice water vat putting into high 20cm, diameter 18cm, depth of water 10cm, water temperature 23 ± 2 DEG C after the 2nd day administration 1h, observe 7min, adapt to 2min, the accumulative dead time (s) in 5min after record.
Experimental data is used
represent, experimental result SPSS11.5 statistical software process, by One-Way ANOVA method, homogeneity of variance LSD and SNK inspection.Experimental result is in table 2.
Table 2 gastric infusion Chinese medicine composition of the present invention on the impact of mouse forced swimming test (
)
Note: compared with model group
*p<0.05;
*p<0.01
Experimental result shows, gastric infusion Chinese medicine composition of the present invention object height, middle dosage group all obviously can shorten the mouse forced swimming test dead time and (compare with model group, P<0.01, P<0.05), and in obvious dose-effect relationship, point out Chinese medicine composition of the present invention to have good antidepressant function; The effect of Chinese medicine composition high dose group of the present invention is suitable with positive drug effect.
Test example 3 Chinese medicine composition lumbar injection of the present invention is on the impact of Mouse Forced Swim Test
1. experiment material
ICR mice, male, body weight 18 ~ 20g, is provided by dimension tonneau China animal experimental center.
Chinese medicine composition of the present invention (self-control is prepared into corresponding preparation by the method described in various embodiments of the present invention before using); Positive drug, fluoxetine hydrochloride capsules (fluoxetine hydrochloride capsules), Xin Gang pharmaceutical factory of Shanghai Westen and Chinese Tranditional Medicine Pharamacentic Co., Ltd.
JZ type 300g tonotransducer (Gaobeidian City newly navigate accumulation equipment company limited), Medlab System of organism signal (Nanjing is easily beautiful).
2. test method and result
Normal mouse is divided into 17 groups at random by body weight, often organize 20, i.e. model group, positive drug fluoxetine hydrochloride capsules (0.0035g/kg), embodiment 1 Chinese medicine composition object height (46g/kg), in (23g/kg), low (11.5g/kg) dosage group, embodiment 10 Chinese medicine composition object height (46g/kg), in (23g/kg), low (11.5g/kg) dosage group, embodiment 14 Chinese medicine composition object height (46g/kg), in (23g/kg), low (11.5g/kg) dosage group, embodiment 18 Chinese medicine composition object height (46g/kg), in (23g/kg), low (11.5g/kg) dosage group, embodiment 21 Chinese medicine composition object height (46g/kg), in (23g/kg), low (11.5g/kg) dosage group.Each group all by the administration of 0.2mL/10g body weight.
Intraperitoneal injection group administration 30min tests.Use immobilization with adhesive tape on the line of 100g tonotransducer mice tail end (apart from tail point 2cm place), make it be the state of hanging by the feet, head separating test platform is about 15cm, tests 2 animals at every turn simultaneously, separates each other with cardboard.Transducer is connected to Medlab System of organism signal, and after adapting to 2min, the result within record 6min, is converted into the time (s) by motionless state.
Experimental data is used
represent, experimental result SPSS11.5 statistical software (purchased from American SPSS Inc.) carries out variance analysis.Experimental result is in table 3.
Experimental result shows: lumbar injection Chinese medicine composition of the present invention object height, middle dosage group all significantly can shorten the mouse tail suspension dead time and (compare with model group, P<0.01, P<0.05), and in obvious dose-effect relationship, point out Chinese medicine composition of the present invention to have good antidepressant function; The effect of Chinese medicine composition high dose group of the present invention is suitable with positive drug effect.
Table 3 lumbar injection Chinese medicine composition of the present invention on the impact of mouse tail suspension dead time (
)
Note: compared with model group
*p<0.05;
*p<0.01
The impact that test example 4 Chinese medicine composition of the present invention is tested mice reserpine induction temperature decline
1. experiment material
ICR mice, male, body weight 20.0 ~ 22g, is provided by dimension tonneau China animal experimental center.
Chinese medicine composition of the present invention (self-control is prepared into corresponding preparation by the method described in the embodiment of the present invention before using); Positive drug: paroxetine (seroxat), Sino-America Tianjin Shike Pharmaceutical Co., Ltd.'s product; Reserpine: Guangdong Bang Min pharmaceutical Co. Ltd.
GM222 type electronic thermometer, stopwatch.
2. test method and result
Normal mouse is divided into 17 groups at random by body weight, often organize 10, i.e. model group normal saline group, paroxetine matched group (0.003g/kg/d), embodiment 1 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 10 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 14 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 18 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 21 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group.
Within 1 hour after administration in the 8th day, measure mice anus temperature, then through lumbar injection reserpine 2mg/kg, within 4 hours, measure mice anus temperature again in injection reserpine.Each thermometric chronothermometer inserts the degree of depth of mice anus and the time homogeneously causes.
Experimental data is used
represent, experimental result SPSS11.5 statistical software (purchased from American SPSS Inc.) carries out variance analysis.Experimental result is in table 4.
Table 4 Chinese medicine composition of the present invention on the impact of mice reserpine induction temperature decline (
)
Note: compared with model group
*p<0.05;
*p<0.01
Experimental result shows: Chinese medicine composition object height of the present invention, middle dosage group and positive drug control group (paroxetine group) all significantly can reduce the temperature decline of reserpine induction, (high, middle dosage group compares P<0.01 with model group to have significant difference, P<0.05), point out Chinese medicine composition antidepressant effect of the present invention may with to affect tuber on content of monoamine transmitters relevant.
Test example 5 Chinese medicine composition of the present invention is on the impact of chronic stress depression rat body weight and behavior
1. experiment material
SD rat, male, body weight 180.0 ~ 220g, is provided by dimension tonneau China animal experimental center.
Chinese medicine composition of the present invention (self-control is prepared into corresponding preparation by the method described in various embodiments of the present invention before using); Positive drug: fluoxetine hydrochloride capsules (fluoxetine hydrochloride capsules), Xin Gang pharmaceutical factory of Shanghai Westen and Chinese Tranditional Medicine Pharamacentic Co., Ltd.
Sucrose, purchased from China of Beijing state chemical reagent factory.
Baking oven, rat fix cage, mosquito forceps, bucket, thermometer, vola click case, and 1/100 stopwatch, rat behavior observes spacious case, rat jumping response case.
2. experimental technique
Normal rat gives 1% sucrose water, measures the consumption in 1 hour after within 24 hours, prohibiting water non-fasting.18 groups are divided at random by body weight, namely blank group, model group, fluoxetine Hydrochloride matched group (0.0035g/kg/d), embodiment 1 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 10 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 14 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 18 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 21 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group.Modeling is gastric infusion simultaneously, once a day, and successive administration 21 days.Each group, all by the administration of 1.0ml/100g body weight, claims a body weight weekly.
Reference literature method (Xu Jing, Li Xiaoqiu, the foundation of chronic stress depression model and evaluation thereof, Chinese hehavioral medical science, 2003, 12 (1): 14 ~ 16) modeling (namely adopting CUMS method to make animal models of depression) is carried out: vola of shocking by electricity (36 volts of voltages, every 1 minute electric shock once, once continue 10 seconds, totally 20 times), 4 DEG C of frozen water swimming (5 minutes), 45 DEG C of baking the affected part after applying some drugs (5 minutes), folder tail (1 minute), moist raising (moist bedding and padding), put upside down round the clock (24 hours), fasting (24 hours), fasting (24 hours) etc. stimulate random arrangement in 21 days, give a kind of stimulation every day, except blank group, all single cage of all the other animals is raised, free diet, room temperature (24 ± 1) DEG C, relative humidity (60 ± 10) %.
2.1 animal behavioral study
2.1.1 sucrose water consumption
After each taboo water, measure 1% sucrose water consumption in every treated animal 1 hour.
2.1.2 Open field test (open-field)
Spacious case height 40cm, length and be widely 80cm, uncovered, be black at the bottom of perisporium and case, bottom surface is divided into 25 pieces of grids of area equation.Using animal travels number of squares as horizontal anomalous movement score, with upright number of times for Vertical movements score (liftoff more than the 1cm of two forelimbs).Every animal carries out 1 time and measures, each 3 minutes.
2.1.3 Jumping test
Experimental provision is the reaction chamber that a rectangle black plastic plate is made, and is divided between two.Bottom surface is copper grid, and spacing is 0.8cm, can be energized, and voltage is controlled by a transformator.Between every, a high 5cm is put at right back angle, diameter is the wooden platform of 8cm.Animal is put into reaction chamber endoadaptation environment 3 minutes, then lead to 36V alternating current immediately, animal is shocked by electricity, and normal reaction jumps onto platform to hide noxious stimulation.Most animals may skip on copper grid again or repeatedly, and snap back again after being shocked by electricity platform, so training 5 minutes, and records the time that every rat jumps onto platform, i.e. the response time; Jump off the incubation period of platform for the first time; The number of times shocked by electricity is errors number, first time jump off platform after on the inherent copper grid of 5min cumulative time of staying and the time of staying in this, as school grade.24 as a child reformed test, and namely this remember and keep test, is placed in by rat on platform, energising timing, and record first time adjusts incubation period of lower platform; Errors number on copper grid in the time of staying and 5min.
Institute's testing index all adopt mean ± standard deviation (
) represent, use the variance analysis (ANOVA) in SPSS12.0 software to test, P<0.05 represents that difference has significance.
3. result
3.1 Chinese medicine compositions of the present invention are on the impact of chronic stress depression rat body weight
Table 5 Chinese medicine composition of the present invention on the impact of chronic stress depression rat body weight (
g)
Note: compared with model group
*p<0.05
Experimental result is in table 5.Result shows, tests the 0th day, 7 days each treated animal body weight no significant differences (P>0.05); Test and organize comparison model group rat body weight significantly reduce (P<0.05) with blank for the 14th day, the middle and high dosage group of Chinese medicine composition of the present invention and positive drug group rat body weight significantly increase (P<0.05) compared with model group; Test and organize comparison model group rat body weight significantly reduce (P<0.05) with blank for the 21st day, the middle and high dosage group of Chinese medicine composition of the present invention and positive drug group rat body weight significantly increase (P<0.05) compared with model group.
3.2 Chinese medicine compositions of the present invention are on the impact of chronic stress depression rat sucrose water consumption
Result shows, tests the 0th day, 7 days each treated animal sucrose water consumptions no significant difference (P>0.05); Test and compare with model group for the 14th day, the middle and high dosage group of Chinese medicine composition of the present invention and positive drug group rat sucrose water consumption significantly increase (P<0.05); Test and organize comparison model group rat sucrose water consumption significantly reduce (P<0.01) with blank for the 21st day, the middle and high dosage group of Chinese medicine composition of the present invention and positive drug group rat sucrose water consumption significantly increase (P<0.01) compared with model group.Experimental result is in table 6.
Table 6 Chinese medicine composition of the present invention on the impact of chronic stress depression rat sucrose water consumption (
mg)
Note: compared with model group
*p<0.05;
*p<0.01
3.3 Chinese medicine compositions of the present invention open the impact of case crawler behavior on chronic stress depression rat
Result shows, compared with blank group, model group rats horizontal movement score, the score that moves both vertically significantly reduce (P<0.05); Compare with model group, the middle and high dosage group of Chinese medicine composition of the present invention and positive drug group rat horizontal movement score, the score that moves both vertically significantly increase (P<0.05).Experimental result is in table 7.
Table 7 Chinese medicine composition of the present invention on chronic stress depression rat open case activity impact (
)
Note is compared with model group
*p<0.05
3.4 Chinese medicine compositions of the present invention are on the impact of chronic stress depression rat diving tower behavior
Result shows, model group rats training period errors number and testing period errors number significantly increase (P<0.01) than blank group; Compare with model group, in Chinese medicine composition of the present invention, dosage group compares remarkable minimizing (P<0.05) with positive drug group rat.Experimental result is in table 8.
Table 8 Chinese medicine composition of the present invention on the impact of chronic stress depression rat diving tower behavior (
)
Note: compared with model group
*p<0.05;
*p<0.01
4. conclusion
It stress be one of pathogenic factors of depression, the animal models of depression that application CUMS manufactures, the change such as behavioristics and neuroendocrine and human depression are similar in its simulation, have become one of animal model of the pathogenesis of discussion depression both at home and abroad and antidepressants mechanism of action and extensive use.But in the past in research the Stress model that adopted mostly be single form stress, as constraint, forced swimming etc.In order to avoid animal produces adaptation to same stressor, this research have employed multifactorial Chronic Stress Model, different stress stimulations is acted on animal by every day at random, make its unpredictable stress time of origin and type, promote that the mechanism of the generation of depression and development is more close with chronic in human depression, low-level stressor.Combine lonely foster, change social animal living environment on this basis, more ensure the success of model.Rat model horizontal anomalous movement and Vertical movements score significantly reduce, and sucrose solution consumption obviously reduces, and illustrate that Animal performance goes out depressive state, and hebetude, exploratory behavior reduce and anhedonia, show rat depression model modeling success.
From spacious case inquiry activity, diving tower behavior, body weight with show sucrose solution consumption test result, Chinese medicine composition of the present invention effectively can improve the Depressive behavior of depression model rat, have therapeutical effect to depression, the action effect of high dose group and positive drug are substantially suitable.
Test example 6 Chinese medicine composition of the present invention on monoamine neurotransmitter in chronic stress rat brain impact
1. experiment material
SD rat, male, body weight 220 ~ 240g.Thered is provided by dimension tonneau China animal experimental center.
Chinese medicine composition of the present invention (self-control is prepared into corresponding preparation by the method described in various embodiments of the present invention before using); Positive drug: fluoxetine hydrochloride capsules (fluoxetine hydrochloride capsules), Xin Gang pharmaceutical factory of Shanghai Westen and Chinese Tranditional Medicine Pharamacentic Co., Ltd, rat consumption is 0.0025g/kg.
Norepinephrine (NE, Serva company); Dopamine (DA, Fluka company); 5-hydroxy tryptamine (5-HT, Sigma company); DOPAC (DOPAC, Sigma company); 3,4-dihydroxy benzylamine (DHBA, Sigma company); Di-n-butylamine (Solution on Chemical Reagents in Shanghai factory), D-8 ion-pairing agent (Tianjin chemical reagent two factory), methanol (top grade is pure, Beijing Chemical Plant), other reagent are domestic analytical pure.
Waters510 pump, M464 electrochemical detector DL-822 chromatographic work station, MSE150 type ultrasonic disintegrator.
2. experimental technique
2.1 grouping and administrations
SD rat, 24h gives 1% sucrose water after prohibiting water non-fasting, measures the consumption in 1h.17 groups are divided at random according to sucrose water consumption, often organize 12, namely blank group, model group, fluoxetine Hydrochloride matched group (0.0025g/kg/d), embodiment 1 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 10 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 14 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 18 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group, embodiment 21 Chinese medicine composition object height (46g/kg/d), in (23g/kg/d), low (11.5g/kg/d) dosage group.Modeling is gastric infusion simultaneously, once a day, and successive administration 21 days.Each group, all by the administration of 1.0mL/100g body weight, claims a body weight weekly.
2.2 modeling
Normal group 6/cage is raised, and normal diet is drunk water, and does not give any stimulation.
Other five groups, 1/cage is raised, and accepts 21 days unpredictable stress stimulations, comprising: frozen water is swum, baking the affected part after applying some drugs, folder tail, and moist raising, puts upside down, fasting round the clock, prohibits water etc.Often organize and give a kind of stimulation every day at random.
Often kind stress concrete operation method:
(1) frozen water swimming: animal is put into the bucket filling 4 DEG C of cold water (frozen water mixing), depth of water 15cm, rat toe just can touch drum head, is taken out by animal after 5min.
(2) baking the affected part after applying some drugs: oven temperature is adjusted to 45 DEG C and fixes, and animal is put into baking oven, is taken out by animal after 5min.
(3) press from both sides tail: rat is put into fixing cage, exposes tail, clamp apart from tail heel 1cm place (firmly not excessive, to make rat send and whine) with mosquito forceps, continue 1min.
(4) moistly to raise: morning 8 point, in mouse cage, add 200ml water, change to next day 8.
(5) put upside down round the clock: morning 8 point, rat is put into dark case, turns on lamp illumination at 8 in evening, to early 8 points next day.
(6) fasting: 24 fractures.
(7) water is prohibited: 24h cuts off the water supply.
2.3 sample preparations and detection
Animal sacrificed by decapitation, peels off brain on ice rapidly, gets prefrontal cortex, weighs rearmountedly to organize in cryovial with after liquid nitrogen quick freezing, puts into-70 DEG C of Refrigerator stores to measuring.
According to the weight of cerebral tissue, the 0.1mol/L adding pre-cooling crosses chloric acid (including 0.3mM EDETATE SODIUM and 0.5mM sodium sulfite), 2 μ g/mL DHBA, be mixed with 800 μ L, ultrasonic homogenate, the centrifugal 10min of 11000rpm, supernatant is used for neurotransmitter and measures.
Adopt high-efficient liquid phase chromatogram-electrochemical detector system (HPLC-ECD) to measure, chromatographic condition is: chromatographic column is 4 × 150mm, Nova-pak C18,5 μm; Mobile phase is 50mM citric acid-sodium acetate buffer pH3.5 (including 1.0mM B-8 ion-pairing agent, 1.8mM di-n-butylamine, 0.3mM EDETATE SODIUM, 4% methanol), flow velocity 1.0mL/min, glassy carbon working electrode, and detection cell voltage is+0.75V; 3,4-dihydroxy benzylamine DHBA is internal standard substance, and in sample, each key component internal standard method carries out quantitatively.
Detect data with
represent, with SPSS 13.0 software processes, by One-Way ANOVA method, testing result is in table 9,10.
Table 9 Chinese medicine composition of the present invention on the impact of methylepinephrine in chronic stress depression rat brain (
)
Note: compared with model group
*p<0.05
Table 10 Chinese medicine composition of the present invention on the impact of serotonin in chronic stress depression rat brain (
)
Note: compared with model group
*p<0.05
Experimental data in table 9, table 10 shows, successive administration, after 21 days, obviously reduces (P<0.05) with monoamine neurotransmitter norepinephrine, 5-hydroxy tryptamine content in blank group comparison model group rat brain; Compare high dose group in Chinese medicine composition of the present invention to close monoamine neurotransmitter norepinephrine, 5-hydroxy tryptamine content in positive drug group rat brain obviously raise (P<0.05) with model group.
Monoamine transmitters in brain, as norepinephrine.The insufficiency of function such as 5-hydroxy tryptamine and dopamine, causes depression.The reason causing depression while reserpine blood pressure lowering is exactly make due to reserpine caused by the norepinephrine exhaustion in presynaptic membrane vesicle.In this experimentation display chronic stress rat brain, 5-hydroxy tryptamine, Noradrenaline Contents obviously reduce, and Chinese medicine composition of the present invention can significantly improve the content of 5-hydroxy tryptamine, norepinephrine.The above effect of prompting may be one of important mechanisms of the antidepressant effect of Chinese medicine composition of the present invention.
Test example 7 Chinese medicine composition emergency toxicology experiment of the present invention
Rat Fast 16 as a child, with the dosage of Cmax (57.5mg/mL), maximum volume (20mL/kg body weight), (24h) on the one interior gastric infusion 2 times, in one day, maximum dosage-feeding is 2300mg/kg body weight, is equivalent to 670 times of clinical people's consumption (240mg/ day).Continuous Observation 14 days, none example is dead.6 months are taken to rat by the dosage of 70,35,17.5 times intending clinical people's consumption, within 4 weeks, carry out general status, body weight, food ration, routine blood test, blood coagulation, blood biochemical, electrocardiogram, main organs index and pathology respectively after administration after 3 months, 6 months and drug withdrawal substantially and under mirror to check, all do not find obvious pathological change.Toxicologic study shows, Chinese medicine composition safety of the present invention, low toxicity.
Claims (10)
1. the application of following pharmaceutical composition in the medicine preparing treatment or prevention of depression,
Radix Ginseng 10-150 part Folium Ginkgo 10-200 part
Stigma Croci 0.1-50 part
Above-mentioned number is weight portion.
2. apply as claimed in claim 1, it is characterized in that consisting of of described compositions:
Radix Ginseng 20-100 part Folium Ginkgo 20-150 part
Stigma Croci 0.1-40 part
Above-mentioned number is weight portion.
3. apply as claimed in claim 2, it is characterized in that consisting of of described compositions:
Radix Ginseng 30-50 part Folium Ginkgo 30-120 part
Stigma Croci 0.4-10 part
Above-mentioned number is weight portion.
4. apply as claimed in claim 3, it is characterized in that consisting of of described compositions:
Radix Ginseng 40 parts of Folium Ginkgos 60 parts
Stigma Croci 5 parts
Above-mentioned number is weight portion.
5. the application as described in claim 1-4, is characterized in that the Radix Salviae Miltiorrhizae of described compositions also containing 10-50 part.
6. apply as claimed in claim 5, it is characterized in that the Radix Salviae Miltiorrhizae of described compositions also containing 15-30 part.
7. apply as claimed in claim 1, it is characterized in that consisting of of described compositions:
Radix Ginseng 80 parts of Folium Ginkgos 100 parts
Stigma Croci 4 parts of Radix Salviae Miltiorrhizaes 10 parts
Above-mentioned number is weight portion.
8. the application as described in claim 1-7, is characterized in that described compositions and the pharmaceutically acceptable adjuvant of at least one are prepared into liquid preparation, solid and semi-solid preparation, gaseous formulation.
9. apply as claimed in claim 8, it is characterized in that described liquid preparation comprises oral liquid, suspension, syrup, injection, medicated wine, tincture, described solid and semi-solid preparation comprise tablet, pill, unguentum, sublimed preparation, powder, granule, suppository, powder, Emulsion, masticatory and capsule, and described gaseous formulation comprises aerosol and inhalant.
10. apply as claimed in claim 9, it is characterized in that described compositions can be prepared into capsule.
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| CN1413656A (en) * | 2002-10-14 | 2003-04-30 | 刘建勋 | Weinakang for treating ischemic cerebrovascular disease and senile dementia and its preparation method |
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| CN1413656A (en) * | 2002-10-14 | 2003-04-30 | 刘建勋 | Weinakang for treating ischemic cerebrovascular disease and senile dementia and its preparation method |
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| WO2016107540A1 (en) * | 2014-12-30 | 2016-07-07 | 神威药业集团有限公司 | Chinese medicinal composition for preventing or treating cardiovascular and cerebrovascular diseases or dementia, and preparation method and use thereof |
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