CN102258753B - Chinese medicinal composition for treating poststroke depression and preparation method thereof - Google Patents
Chinese medicinal composition for treating poststroke depression and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal composition for treating poststroke depression. The raw materials of the active ingredients of the Chinese medicinal composition comprise the following components in percentage by weight: bupleurum, grassleaf sweelflag rhizome, turmeric root tuber, cortex albiziae, morinda officinalis and thin leaf milkwort root bark. The Chinese medicinal composition is exact in treatment effect and small in toxic and side effect and avoids arousing dependence; and thus, the Chinese medicinal composition can be taken safely and reliably for a long time. The invention also discloses the preparation method of the Chinese medicinal composition comprises the following steps: weighing the components of the raw materials; crushing bupleurum for later use; decocting other five Chinese medicines in water twice, combining filtrate obtained at first time and the filtrate obtained at the second time, concentrating the obtained filtrate into paste, drying the paste at a low temperature, crushing into fine powder, sieving and collecting the undersize powder for later use; and fully mixing the obtained powdered material to obtain the active ingredients of the Chinese medicinal composition, and preparing required preparations by the conventional preparation method. The steps are simple, the method is easy to implement, and the process is stable.
Description
Technical field
The invention belongs to Chinese patent drug technique field, be specifically related to a kind of Chinese medicine composition for the treatment of poststroke depression, the invention still further relates to the preparation method of this Chinese medicine composition.
Background technology
1, the harm of apoplexy
Apoplexy is harm humans life and healthy commonly encountered diseases and frequently-occurring disease, has the advantages that sickness rate is high, mortality rate is high, disability rate is high, relapse rate is high, occupies the 3rd of mankind's cause of death and first of the reason of disabling." the Third National residents " of China's Ministry of Public Health announcement in 2008 shows: cerebrovascular is first cause of the death, accounts for 22.45%; Annual new 2,000,000 people, dead 1,500,000 people, 75% disables, and relapse rate 41% in 5 years; Existing patient 6,000,000-7,000,000 people, annual direct medical cost expenditure is 20,000,000,000 yuan.Because apoplexy not only causes great misery to patient's body and mind, and bring huge spirit and financial burden for society and family, therefore, medical circle is more and more paid close attention to generation, development and the prophylactico-therapeutic measures research to apoplexy.
2, poststroke depression is to affect the key factor that apoplexy recovers
Poststroke depression (Post-Stroke Depression, PSD) refer to the rear depression that causes of apoplexy (for the tranquillization apoplexy) of obvious clinical symptoms, show as sad or gloomy, depressed, be to a kind of abnormal negative emotions reaction of losing, disappointed or failure produces.The evidence-based medical of multicenter, international clinical trial shows, being emotionally stable of patients with cerebral apoplexy plays a part crucial to rehabilitation and the treatment of apoplexy.Studies show that, the mortality rate of poststroke depression is 3-4 times of non-poststroke depression, not only brings body and spiritual misery to the patient, has also increased the burden of family and society.Along with transformation and the arrival in global aging stage of biologic and psychogenic society medicine pattern, the research of poststroke depression is obtained the extensive concern of Chinese scholars.
3, the prophylactico-therapeutic measures progress of poststroke depression
The progress of relevant antidepressant drug is very fast in recent years, and the new drug of exploitation is more.Mainly contain ten large class medicines and can supply selection of clinical.At present for poststroke depression take the treatment apoplexy as the basis, coordinate traditional tricyclic antidepressant, 5-HT reuptake inhibitor, psychostimulant and other therapies (as electrofit).These antidepressants curative effects are close, heart and brain toxic and side effects is in various degree all arranged, and cause allergy and drug withdrawal syndrome, therefore clinical practice is often restricted.So determined curative effect, the Chinese medicine that toxic and side effects is less more and more become the emphasis of clinical practice, and are accepted by vast clinical position person and patient with its unique advantage, obtain satisfactory effect.
Post-apoplectic belongs to the traditional Chinese medical science " melancholia " category.To its etiology and pathogenesis, ancient Chinese medicine doctor is discussed a lot of." ancient Chinese medical classics trace back back collection five strongly fragrant opinions " cloud: " rising of all diseases is also many due to strongly fragrant, strongly fragrant person, stagnant and obstructed meaning ", explicitly point out depression and stagnation of QI obstructed for melancholia because of." danxi's experiential therapy " proposes saying of " six kinds of stagnation-syndromes ", points out: " QI and blood punching and, ten thousand diseases are not given birth to, one strokes strongly fragrantly, all diease occurrences are here ", emphasized the effect of disharmony between QI and blood in the melancholia morbidity.Jing-Yue Complete Works with the strongly fragrant of the interior life in pathological process with become the lesion to be divided into " stagnation of QI-blood due to disease " and " disease due to stagnation of QI-blood " because of feelings pent-up that will is hindered, point out: " all five gas strongly fragrant, all diseases all have, due to illness and also strongly fragrant this.As for feelings will is strongly fragrant, always by the heart this because of strongly fragrant and sick also." along with deepening continuously to Post-apoplectic research; the formation of modern Chinese medicine scholar centering wind Depression and the relation between apoplexy and depression have had more deep understanding; proposed many new viewpoints; make Post-apoplectic etiology and pathogenesis theory constantly perfect, promoted the development of traditional Chinese medical science science.Post-apoplectic belongs to the combination of syndromes of Chinese medicine " melancholia " and " apoplexy ", with regard to its cause effect relation, " melancholia " is the deteriorated case of " apoplexy ", on the basis of apoplexy, because the pent-up of fighting of wind, the stasis of blood, expectorant, fiery glue causes QI and blood stasis not smooth, irritability is lost it and is reached that gods are lost its clear exhibition and depressed, forms melancholia.Depressed existing strongly fragrant state of an illness will is not relaxed therefore apoplexy merges, the characteristics of functional activity of QI being not smooth, and the characteristics of apoplexy are arranged again, with disorder of QI and blood, phlegm and blood stasis, on disturb clearly key, mind disorder is relevant.Apoplexy is sent out the initial stage patient owing to being subjected to the invalid puzzlement of body, depression, and feelings will is not smooth, and the depression and stagnation of QI liver is lost bar and reaches, and the course of disease with the passing of time easily causes void and causes the stasis of blood.Caused by liver and kidney deficiency, essence and blood secretly consume, brain lose to be supported, and unsuccessful, the irritability stasis of feelings will, qi depression to blood stasis, the god of unit lose foster or disturbed and causes the generation of melancholia in addition.Therefore Post-apoplectic belongs to " due to illness and strongly fragrant ", forefathers' said " melancholia " more refer to " because of strongly fragrant and sick ", and both etiology and pathogenesis are incomplete same.Zhi Shi etc. carry out clinical observation and analysis to 240 routine patients with cerebral infarction, the relation of Cerebral infarction Syndrome Types of TCM and depression, and the result demonstration, the sickness rate that obstruction of collateral caused by windphlegm type and Qi deficiency blood stasis type merge depression is relatively high.Show that apoplexy merges melancholia in close relations with " void, expectorant, the stasis of blood ", " void, expectorant, the stasis of blood " played very important effect between apoplexy and melancholia.
The Western medicine that is used for the treatment of clinically at present depression mainly divides following a few class: 1. tricyclic antidepressants down, as imipramine, amitriptyline etc.; Oxidase inhibitor is as benzene hydrazine, Clorgiline etc.; 2. monoamine cell reabsorption inhibitor is as serotonin, NRI maprotiline, selectivity norepinephrine cell reabsorption inhibitor fluoxetine, paroxetine etc.; 3. tetracyclic antidepressant such as mianserin, triazolone etc.; 4. the antidepressant of other types such as Phenylpiperazine derivatives nefazodone and aminoketones antidepressant amfebutamone etc., because present doctor trained in Western medicine antidepressants obviously exist side effect serious, the problems such as onset is slow, and is expensive make its application have significant limitation.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition for the treatment of poststroke depression, determined curative effect, toxic and side effects is little, no dependence, long-term taking is safe and reliable.
Another object of the present invention is to provide the preparation method of above-mentioned Chinese medicine composition.
The technical solution adopted in the present invention is, a kind of Chinese medicine composition for the treatment of poststroke depression, the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 14%～20%, Rhizoma Acori Graminei 14%～20%, Radix Curcumae 14%～20%, Cortex Albiziae 14%～20%, Radix Morindae Officinalis 14%～20%, Radix Polygalae 12%～18%, the percentage by weight summation of above each component is 100%.
Further, this Chinese medicine composition is capsule preparations.
Another technical scheme of the present invention is that the preparation method of the Chinese medicine composition of this treatment poststroke depression comprises the following steps:
Step 1: take by weight percentage following material component: the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 14%～20%, Rhizoma Acori Graminei 14%～20%, Radix Curcumae 14%～20%, Cortex Albiziae 14%～20%, Radix Morindae Officinalis 14%～20%, Radix Polygalae 12%～18%, the percentage by weight summation of above each component is 100%;
Step 2: the Radix Bupleuri that step 1 takes is pulverized, standby;
Step 3, Rhizoma Acori Graminei, Radix Curcumae, Cortex Albiziae, Radix Morindae Officinalis and Radix Polygalae Chinese medicine of the five flavours that step 1 is taken decoct with water 2 times, add for the first time the decocting of 10 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1～2 hour, filter, add for the second time the decocting of 8 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1～2 hour, filter, merge filtrate twice, with gained filtrate be condensed into temperature 50 ℃ the time, relative density is 1.25～1.30 thick paste, and is standby;
Step 4, the Chinese Thorowax Root that step 2 is obtained and and the thick paste that obtains of step 3 fully mix, make required preparation according to the conventional formulation method.
Further, in step 4, in the mixture that obtains, add appropriate amount of starch, mixing, granule processed, drying, granulate incapsulates, and namely gets capsule.
It is rigorous that the present invention treats the full side's compatibility of Chinese medicine composition of poststroke depression, giving consideration to both the incidental and fundamental.Its pioneering refreshment resolving depression, the treatment poststroke depression of invigorating blood circulation reduces phlegm, treating both the principal and secondary aspects of a disease, Long-term Clinical Observation and lot of experiments curative effect are certainly, can alleviate Degree of Depression, the neurologic impairment that can have the efficient recovery apoplexy to cause again, promote limb functional recover, improve life in patients, reduce disability rate.Be pure Chinese medicinal preparation, toxic and side effects is little, but long-term taking, and no dependence has safety, effective, the advantage for the treatment of both the principal and secondary aspects of a disease.
The present invention treats the preparation method of the Chinese medicine composition of poststroke depression, and step is simple, easily implements process stabilizing.
The specific embodiment
The present invention is described in detail below in conjunction with the specific embodiment.
The present invention treats the Chinese medicine composition of poststroke depression, the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 14%～20%, Rhizoma Acori Graminei 14%～20%, Radix Curcumae 14%～20%, Cortex Albiziae 14%～20%, Radix Morindae Officinalis 14%～20%, Radix Polygalae 12%～18%, the percentage by weight summation of above each component is 100%.
In the present invention, take Rhizoma Acori Graminei as monarch drug, Xin Wen is with the removing dampness eliminating phlegm.Rhizoma Acori Graminei, Radix Polygalae mutual reinforcement between, are eliminated the phlegm and are had one's ideas straightened out at the refreshment resolving depression.Being equipped with Radix Curcumae, Radix Bupleuri, Cortex Albiziae is ministerial drug, bitter in the mouth, cool in naturely enters the heart, Liver Channel with liver-smoothing, qi-regulating, promoting QI circulation for relieving depression.Radix Morindae Officinalis is assistant, and reinforcing the kidney and supporting YANG, nourishing the liver and kidney are to effect a permanent cure.Full side's compatibility is rigorous, giving consideration to both the incidental and fundamental; Regulate the flow of vital energy righting effecting a permanent cure, the refreshment resolving depression, reduce phlegm and invigorate blood circulation to take stopgap measures.
In Chinese medicine composition of the present invention, the character of each component and main pharmacological are:
Radix Bupleuri: mainly contain the compositions such as volatile oil, fatty oil, bupleurumol, Radix Bupleuri glycosides, rutin.Modern pharmacological research shows, the zoopery liver damage due to Radix Bupleuri is mould etc. to carbon tetrachloride, antityphoid vaccine, penicillium has remarkable antagonism.Saikoside has to hepatocyte device film the effect that makes it stable, and is particularly remarkable to the effect of plasmalemma, microsomal membrane, mitochondrial membrane.Saikoside α has peroxidization in the liver of inhibition, and the damaging action of minimizing radical pair liver has the outer malicious ability of the liver of promotion, the effect of lipid metabolism in protection hepatocyte and promotion liver.For stablizing of preparation, Radix Bupleuri is advisable with pulverizing.
Rhizoma Acori Graminei: mainly contain volatile ingredient and other.Modern pharmacological research shows, Rhizoma Acori Graminei water decoction and go the water decoction of volatile oil all to have the antagonism pentetrazole to cause the convulsion effect of mice.α in contained volatile oil-asaricin pentetrazole and electrofit also have obvious inhibitory action.Rhizoma Acori Graminei is advisable with water extraction.
Radix Curcumae: mainly contain volatile oil, curcumin chemical compounds and other.Modern pharmacological research shows, the contained volatile oil of Radix Curcumae has the bile secretion of promotion and Excretion, reduces the urobilinogen in urine.Radix Curcumae decocting liquid has inhibitory action to multiple pathogenic fungus.Radix Curcumae is advisable with water extraction.
Cortex Albiziae: mainly contain saponin, tannin etc.Modern pharmacological research shows, Cortex Albiziae can not Cure for insomnia, and consumption hour due to the compatibility of the sedatives such as Semen Ziziphi Spinosae, can not show the excitation of Cortex Albiziae; After heavy dose of the application, Cortex Albiziae has suppressed the effect of other sedative Cure for insomnia, obviously demonstrates the excitation of Cortex Albiziae.This has good effect to patients with depression.Cortex Albiziae is advisable with water extraction.
Radix Morindae Officinalis: mainly contain anthraquinone, steroidal, aminoacid, saccharide etc.Modern pharmacology studies show that, the Radix Morindae Officinalis herbal decoction can significantly be improved Levels of Monoamine Transmitters in all signs of reserpinization mice and brain thereof, and its water solubility extract and isolated 5 monomers all have significant antidepressant activity.Existing laboratory research and clinical observation think that all the water extract of Radix Morindae Officinalis has antidepressant pharmacologically active, and toxic and side effects is little, better tolerance, and its kidney tonifying functions is conducive to the recovery of apoplexy primary disease.Radix Morindae Officinalis is advisable with water extraction.
Radix Polygalae: mainly contain triterpene saponin, also contain alkaloid, sugar etc.Modern pharmacological research shows, Radix Polygalae has stronger anticonvulsant action.Radix Polygalae has multiple effect to nervous system, the Radix Polygalae root bark, does not go the full root of Radix Polygalae and the root core of core to barbiturate, synergism to be arranged all.Radix Polygalae is advisable with water extraction.
Function cures mainly: the refreshment resolving depression, reduce phlegm and invigorate blood circulation, regulate the flow of vital energy righting.Be used for after apoplexy feelings will unsuccessful due to melancholia, the depressions such as that disease sees that post-stroke occurs is depressed, bradyphrenia, speech action minimizing.
Usage and dosage: the capsule that oral Chinese medicine composition of the present invention is made, one time 3, every contains crude drug 0.35g, 3 times on the one.(PLSCONFM herein)
The preparation method of this Chinese medicine composition comprises the following steps:
Step 1: take by weight percentage following material component: the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 14%～20%, Rhizoma Acori Graminei 14%～20%, Radix Curcumae 14%～20%, Cortex Albiziae 14%～20%, Radix Morindae Officinalis 14%～20%, Radix Polygalae 12%～18%, the percentage by weight summation of above each component is 100%;
Step 2: the Radix Bupleuri that step 1 takes is pulverized, standby;
Step 3, Rhizoma Acori Graminei, Radix Curcumae, Cortex Albiziae, Radix Morindae Officinalis and Radix Polygalae Chinese medicine of the five flavours that step 1 is taken decoct with water 2 times, add for the first time the decocting of 10 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1～2 hour, filter, add for the second time the decocting of 8 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1～2 hour, filter, merge filtrate twice, with gained filtrate be condensed into temperature 50 ℃ the time, relative density is 1.25～1.30 thick paste, and is standby;
Step 4, the Chinese Thorowax Root that step 2 is obtained and and the thick paste that obtains of step 3 fully mix, make required preparation according to the conventional formulation method.
Wherein, the effective ingredient (position) of Radix Bupleuri, Rhizoma Acori Graminei, Radix Curcumae, Cortex Albiziae, Radix Morindae Officinalis, Radix Polygalae medicine is all its water soluble ingredients, therefore adopt water boiling and extraction; Radix Bupleuri adopt to be pulverized and to be used as medicine, and can guarantee that effective ingredient (position) gives full play to its drug action, can satisfy the preparation requirement again.Preparation method therefore of the present invention adopts water boiling and extraction to be used as medicine with pulverizing and combines, and gives full play to its drug action to guarantee effective ingredient (position).
In step 4, in the mixture that obtains Chinese Thorowax Root and thick paste, add appropriate amount of starch, mixing, granule processed, drying, granulate incapsulates, and namely gets capsule.
Consider the effect characteristics of each material component, and guarantee that drug release is fast, be beneficial in body and absorb, therefore select drug release fast, store, carry, taking convenience, and the good capsule of medicine stability, as the suitable dosage forms of this product.
Pharmacodynamic experiment
One: to the impact of poststroke depression (Post-Stroke Depression, PSD) rat monoamine neurotransmitters and hippocampus pathological change
Purpose: for illustrating the mechanism of traditional Chinese medicine composition for treating poststroke depression of the present invention.Research, inquire into Chinese medicine composition of the present invention to the impact of monoamine neurotransmitters in the PSD rat brain by experiment, and monoamine neurotransmitters can obviously raise in experiment.Therefore, traditional Chinese medicine composition for treating PSD of the present invention improves depressive symptom by improving monoamine neurotransmitters, recovers neurologic impairment, improves cure rate.Conclusion: research by experiment, the large, medium and small dosage of the capsule that Chinese medicine composition of the present invention is made and fluoxetine all can be treated PSD.Dosage big or middle and fluoxetine curative effect are better than low dose, big or middle dosage and fluoxetine therapeutic equivalence.The possible mechanism of traditional Chinese medicine composition for treating PSD of the present invention is to improve patients who suffered with depression by monoamine neurotransmitters in the raising brain, and the neurologic impairment that apoplexy causes is improved significantly.Improve the clinical efficacy of poststroke depression by determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs.
Two: on the experiment of post-stroke depression rat BDNF, NGF impact
Purpose: by experiment, study Chinese medicine composition of the present invention to the impact of PSD rat brain derived neurotrophic factor (BDNF) and nerve growth factor (NGF), to illustrate the possible mechanism of action of its treatment post-stroke depression.conclusion: find treatment group rat brain cortex of frontal lobe and Hippocampus NGF in experiment, the BDNF positive cell number significantly increases, the form rule, express and strengthen, pointing out Chinese medicine composition of the present invention may be by raising NGF, BDNF is in cortex, the expression of hippocampus, improve 5-hydroxy tryptamine, the noradrenaline level, coordinate the balance between 5-hydroxy tryptamine and noradrenaline, and protect 5-hydroxy tryptamine and noradrenaline neuron to avoid the Neuronal Damage that stress cause, promote neuronic regeneration, increase mediator concentration, improve its activity, promotion functions recovers, improve nerve injury and antidepressant effect thereby reach, but its more the mechanism of action of deep layer remain further research.
Three: the structure of post-stroke depression animal model
Purpose: set up post-stroke depression animal model.Conclusion: select one-sided common carotid artery Incomplete ligation method to set up the apoplexy animal model, the hemiplegia mild degree is fit to proceed drug-induced and lonely foster method, and operation is simple, and mortality rate is low, and the repeatability of model better.Stroke model and drug-induced and lonely foster method are combined, set up the post-stroke depression animal model.Observe in experiment and the slight dysfunction of focus contralateral limbs namely occurred after rat operation anesthesia is regained consciousness; Irritability appears in postoperative 1-2 week; The all limb functions of postoperative 1 recover to some extent; 4 weeks of postoperative, namely lonely support and the injection reserpine after 3 weeks the appearance activity reduce, often roll up less moving, anhedonia, prompting PSD rat model is set up.This model has that operation method is simple, and mortality rate is low, and neurological functional deficit is light, the advantage of favorable repeatability.In conjunction with reserpine antagonism and lonely method duplicating model of supporting, method is simple and reliable, easily operation; Simulate the core symptom of mankind's post-stroke depressions, met the clinical onset characteristics.The treatment effect on post-stroke depression persistent period is longer, is conducive to carry out observation of curative effect and the research on mechanism of medicine.
Four: on the impact of Poststroke Depression rat model Hippocampus GDNF mrna expression
Set up the PSD animal model with reference to middle cerebral artery occlusion art (MCAO) the associating gentle stress stimulation of chronic imprevision (CUMS) and the lonely method of supporting.Use the capsule that Chinese medicine composition of the present invention makes the PSD rat is intervened, the behavioristics of observing the test of rat body weight and wilderness and sucrose water consumption test changes and adopts the GDNFmRNA expression in fluorescence real-time quantitative PCR detection rat hippocampus district.After CUMS stimulated 28 days, the capsule treatment group that Chinese medicine composition of the present invention is made increased (P＜0.05), wilderness test score increase (P＜0.05) and sucrose water consumption test ratio than PSD group body weight gain amplitude and increases (P＜0.05); The GDNF mrna expression level for the treatment of group hippocampus is 3.37 times of PSD model group, has increased by 6.2 times than the expression of stroke groups hippocampus GDNF mRNA.Chinese medicine composition of the present invention can obviously improve PSD rat model depressive symptom, and the PSD injured neuron is had protection and repair, and its mechanism may be relevant with GDNFmRNA expression in the rise brain.
Five: on the impact of post-stroke depression rat hippocampus 5-HT1AR and 5-HT2AR mRNA horizontal expression
Experiment behavioristics marks according to the wilderness, and the SD rat is divided into 6 groups at random: blank group, model group, prozac group, the large, medium and small dosage group of the capsule that Chinese medicine composition of the present invention is made.All carry out middle cerebral artery line bolt method and stress (CUMS) method set up the PSD rat model with the lonely method of supporting in conjunction with chronic unpredictalbe mildness except the blank group.GP TH 29 days is respectively organized respectively body weight, sucrose solution consumption and the wilderness experiment score of rat, and was put to death whole rats in the 29th day in measurement in the 1st day, the 15th day, the 29th day for the treatment of, adopt the real-time fluorescence quantitative RT-PCR method to detect rat hippocampus 5-HT
1AR and 5-HT
2AR mRNA level is to observe Chinese medicine composition of the present invention to PSD rat body weight, behavioristics, 5-HT
1AR and 5-HT
2AThe impact of R mRNA horizontal expression.Dosage big or middle and prozac all can obviously improve PSD rat hippocampus 5-HT
1AR mrna expression level, reduction 5-HT
2AR mrna expression level (P＜0.05); Dosage big or middle and prozac are without significant difference (P＞0.05); Low dose of effect is not obvious.Traditional Chinese medicine composition for treating PSD mechanism of the present invention may be by raising 5-HT
1AR mRNA, downward 5-HT
2AThe depressive symptoms such as R mRNA improves in the expression of hippocampus that weight in patients alleviates, interest decline, spontaneous activity and exploratory behavior minimizing.
Long-term toxicity test for animals
Purpose: make evaluation for the safety to Chinese medicine composition of the present invention, provide foundation to clinical experiment, carried out the long term toxicity test of this medicine.Conclusion: show through the rat chronic toxicity test result, the capsule larger dose made from Chinese medicine composition of the present invention (25 times, 50 times and 100 times of amounts of adult's dosage) is given the rat continuous oral longer course for the treatment of (90d and 180d), to growth promoter (body weight gain), hemopoietic function, liver function and the renal function non-toxic reaction of rat, the organs such as the rat heart, liver, lung, kidney, brain are also found no the toxicity damage sexually transmitted disease (STD) manage change in organization.Show that the longer course for the treatment of and large dose oral administration toxicity are very low, safety.In addition, also observe in this test the present invention and have the strong effects such as appetite stimulator, the growth of promotion growing animal, excited hematopoietic function (rising hemoglobin and RBC number).
Acute toxicity testing
Purpose: make evaluation for the safety to Chinese medicine composition of the present invention, provide foundation to clinical experiment, carried out the acute toxicity testing of this medicine, determine median lethal dose(LD 50) (LD50) or maximum tolerated dose.Conclusion: three acute toxicity testing results demonstrations, the maximum tolerated dose of mouse stomach administration is 24.30g/kg/d, is equivalent to 2700 times of people's clinical application every day amount.The maximum tolerated dose of rat oral gavage administration is 12.96g/kg/d, is 1400 times of people's quantity every day; Mouse peritoneal drug administration by injection LD50 is 5.99g/kg, is equivalent to 666 times of people's quantity every day, illustrates that it is safe that Chinese medicine composition of the present invention is used for clinical.
Clinical observation
One: treatment poststroke depression clinical curative effect analysis
Purpose: observe the clinical efficacy to poststroke depression.Conclusion: Chinese medicine composition of the present invention has curative effect preferably to Degree of Depression and the neurologic impairment of poststroke depression.Before and after patient treatment, depression scores and Degree of Depression obviously alleviate before all treating, P＜0.01; Compare with the prozac group, depression scores and Degree of Depression alleviate significantly, P＜0.05.Before and after patient treatment, neurological deficits score and degree obviously alleviate before all treating, P＜0.01; Compare with the blank group, neurological deficits score and degree are improved significantly, P＜0.05.Find by clinical research, traditional Chinese medicine composition for treating poststroke depression of the present invention is evident in efficacy.Can not only improve patients who suffered with depression, and neurologic impairment is had obvious restitution.Cure of depression, curative effect is better than prozac; The treatment apoplexy, curative effect is better than routine clinical treatment.
Two: coordinate psychological consultation treatment poststroke depression clinical curative effect analysis
Purpose: observe the clinical efficacy that coordinates psychological consultation treatment poststroke depression.Result: Chinese medicine composition of the present invention coordinates psychotherapy's group, uses of the present invention group, prozac group patient treatment retarded depression degree cure-remarkable-effectiveness rate to be respectively separately: 73.3%, 63.4%, 56.7%, three group relatively, and difference has significant (P＜0.05).After above-mentioned three groups of patient treatments, the neurologic impairment cure-remarkable-effectiveness rate is respectively: 70.0%, 63.3%, 56.7%, two group relatively, and difference has significant (P＜0.05).Based on " because of strongly fragrant and sick ", we adopt oral Chinese medicine to coordinate the psychological consultation Comprehensive Treatment to obtain satisfactory effect.Good mental status can impel patient's initiative to strengthen limb rehabilitating, and limb function obtains better recovering also the Mental Depression tool to be significantly improved simultaneously.Take in early days psychological intervention, work along both lines, timely.Pay attention to the therapeutic modality that psychology and physiology are laid equal stress on, can obviously improve patient's depressive state, alleviate neurologic impairment, more remarkable than simple oral effect of drugs to the raising of the recovery of its motor function and self care ability.
Embodiment 1
Step 1: take by weight percentage following material component: the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 14%, Rhizoma Acori Graminei 19%, Radix Curcumae 20%, Cortex Albiziae 20%, Radix Morindae Officinalis 15%, Radix Polygalae 12%;
Step 2: the Radix Bupleuri that step 1 takes is pulverized, standby;
Step 3, Rhizoma Acori Graminei, Radix Curcumae, Cortex Albiziae, Radix Morindae Officinalis and Radix Polygalae Chinese medicine of the five flavours that step 1 is taken decoct with water 2 times, add for the first time the decocting of 10 times of amounts of this Chinese medicine of the five flavours gross weight to boil 2 hours, filter, add for the second time the decocting of 8 times of amounts of this Chinese medicine of the five flavours gross weight to boil 2 hours, filter, merge filtrate twice, with gained filtrate be condensed into temperature 50 ℃ the time, relative density is 1.30 thick paste, and is standby;
Step 4, the Chinese Thorowax Root that step 2 is obtained and and after the thick paste that obtains of step 3 fully mixes, in the mixture that obtains, add appropriate amount of starch, mixing, granule processed, drying, granulate incapsulates, and namely gets capsule.
Embodiment 2
Step 1: take by weight percentage following material component: the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 16%, Rhizoma Acori Graminei 14%, Radix Curcumae 15%, Cortex Albiziae 17%, Radix Morindae Officinalis 20%, Radix Polygalae 18%;
Step 2: the Radix Bupleuri that step 1 takes is pulverized, standby;
Step 3, Rhizoma Acori Graminei, Radix Curcumae, Cortex Albiziae, Radix Morindae Officinalis and Radix Polygalae Chinese medicine of the five flavours that step 1 is taken decoct with water 2 times, add for the first time the decocting of 10 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1 hour, filter, add for the second time the decocting of 8 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1 hour, filter, merge filtrate twice, with gained filtrate be condensed into temperature 50 ℃ the time, relative density is 1.25 thick paste, and is standby;
Step 4, the Chinese Thorowax Root that step 2 is obtained and and after the thick paste that obtains of step 3 fully mixes, in the mixture that obtains, add appropriate amount of starch, mixing, granule processed, drying, granulate incapsulates, and namely gets capsule.
Embodiment 3
Step 1: take by weight percentage following material component: the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 20%, Rhizoma Acori Graminei 20%, Radix Curcumae 14%, Cortex Albiziae 14%, Radix Morindae Officinalis 14%, Radix Polygalae 18%, the percentage by weight summation of above each component is 100%;
Step 2: the Radix Bupleuri that step 1 takes is pulverized, standby;
Step 3, Rhizoma Acori Graminei, Radix Curcumae, Cortex Albiziae, Radix Morindae Officinalis and Radix Polygalae Chinese medicine of the five flavours that step 1 is taken decoct with water 2 times, add for the first time the decocting of 10 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1.5 hours, filter, add for the second time the decocting of 8 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1.5 hours, filter, merge filtrate twice, with gained filtrate be condensed into temperature 50 ℃ the time, relative density is 1.5 thick paste, and is standby;
Step 4, the Chinese Thorowax Root that step 2 is obtained and and after the thick paste that obtains of step 3 fully mixes, in the mixture that obtains, add appropriate amount of starch, mixing, granule processed, drying, granulate incapsulates, and namely gets capsule.
Embodiment 4
Step 1: take by weight percentage following material component: the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 17%, Rhizoma Acori Graminei 17%, Radix Curcumae 17%, Cortex Albiziae 17%, Radix Morindae Officinalis 17%, Radix Polygalae 15%;
Step 2: the Radix Bupleuri that step 1 takes is pulverized, standby;
Step 3, Rhizoma Acori Graminei, Radix Curcumae, Cortex Albiziae, Radix Morindae Officinalis and Radix Polygalae Chinese medicine of the five flavours that step 1 is taken decoct with water 2 times, add for the first time the decocting of 10 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1.5 hours, filter, add for the second time the decocting of 8 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1.5 hours, filter, merge filtrate twice, with gained filtrate be condensed into temperature 50 ℃ the time, relative density is 1.5 thick paste, and is standby;
Step 4, the Chinese Thorowax Root that step 2 is obtained and and after the thick paste that obtains of step 3 fully mixes, in the mixture that obtains, add appropriate amount of starch, mixing, granule processed, drying, granulate incapsulates, and namely gets capsule.
Study discovery by Long-term clinical, traditional Chinese medicine composition for treating epilepsy treating both the principal and secondary aspects of a disease of the present invention need not monitored blood drug level, and multi-level, many target treatments are evident in efficacy, can obviously reduce the attack times of epilepsy.
Claims (4)
1. Chinese medicine composition for the treatment of poststroke depression, it is characterized in that, the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 14%～20%, Rhizoma Acori Graminei 14%～20%, Radix Curcumae 14%～20%, Cortex Albiziae 14%～20%, Radix Morindae Officinalis 14%～20%, Radix Polygalae 12%～18%, the percentage by weight summation of above each component is 100%.
2. according to the Chinese medicine composition of the described treatment poststroke depression of claim 1, it is characterized in that, described Chinese medicine composition is capsule preparations.
3. the preparation method of the Chinese medicine composition of the described treatment poststroke depression of claim 1, is characterized in that, comprises the following steps:
Step 1: take by weight percentage following material component: the raw material weight percentage ratio of making effective ingredient consists of: Radix Bupleuri 14%～20%, Rhizoma Acori Graminei 14%～20%, Radix Curcumae 14%～20%, Cortex Albiziae 14%～20%, Radix Morindae Officinalis 14%～20%, Radix Polygalae 12%～18%, the percentage by weight summation of above each component is 100%;
Step 2: the Radix Bupleuri that step 1 takes is pulverized, standby;
Step 3: Rhizoma Acori Graminei, Radix Curcumae, Cortex Albiziae, Radix Morindae Officinalis and Radix Polygalae Chinese medicine of the five flavours that step 1 is taken decoct with water 2 times, add for the first time the decocting of 10 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1～2 hour, filter, add for the second time the decocting of 8 times of amounts of this Chinese medicine of the five flavours gross weight to boil 1～2 hour, filter, merge filtrate twice, with gained filtrate be condensed into temperature 50 ℃ the time, relative density is 1.25～1.30 thick paste, and is standby;
Step 4: the thick paste that the Chinese Thorowax Root that step 2 is obtained and step 3 obtain fully mixes, and makes required preparation according to the conventional formulation method.
4. the preparation method of the Chinese medicine composition of the described treatment poststroke depression of claim 3, is characterized in that, in step 4, in the mixture that obtains, adds appropriate amount of starch, mixing, and granule processed, drying, granulate incapsulates, and namely gets capsule.
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