CN102793760A - Medicinal composition for improving non-dyskinesia of Parkinson disease - Google Patents
Medicinal composition for improving non-dyskinesia of Parkinson disease Download PDFInfo
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Abstract
The invention relates to a medicinal composition for improving depression and sleep disorder in non-dyskinesia of Parkinson disease. The medicinal composition comprises the following components in parts by weight: 1 to 60 parts of epimedium extract, 1 to 300 parts of common cephalanoplos herb flower aqueous extract, 1 to 300 parts of liquorice aqueous extract, and 10 to 600 parts of white paeony root alcoholic extract, wherein the epimedium extract, the liquorice aqueous extract and the white peony root alcoholic extract have the effect of inhibiting depression, while the common cephalanoplos herb flower aqueous extract has a remarkable effect for treating agrypnia. Interaction with medicaments for treating Parkinson disease, such as dopamine precursor, levodopa and a dopamine receptor stimulant, can be reduced due to the compatibility of the components, and the effects of inhibiting depression and sleep disorder can be strengthened. The composition can be produced into solid preparation and/or liquid preparation, and can be applied to preparation of medicaments for improving depression and/or sleep disorder in the non-dyskinesia of Parkinson disease.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for the auxiliary treatment of Parkinson's disease, particularly relate to a kind of non-dyskinetic pharmaceutical composition of parkinson disease that is used to improve.
Background technology
Parkinson disease (Parkinson Disease; PD) be the chronic neurological degenerative disease; Clinical mainly show as tremble, stiff, bradykinesia and posture be unstable, sickness rate increases along with the aging of population gradually, 60 years old and above old man PD prevalence are about 1%.To PD have at present that Drug therapy, operation damage that pallidum, brain depth electrode bury, electrostimulation, cell transplantation and gene therapy etc.Because several factors restriction, Drug therapy is still main method, clinical in the most frequently used Western medicine have madopar, breath peaceful etc., belong to replacement therapy.Western medicine is rapid-action, to the patient of initial application, can improve motor symptoms very soon.The treatment of parkinson disease (PD) is main with Western medicine at present, but these medicines all can not stop the progress of the state of an illness, and along with disease progression, dosage can increase gradually, and severe complications and side effect can appear in many patients.Untoward reaction comprises the untoward reaction of periphery property such as gastrointestinal tract, cardiovascular, and curative effect goes down (agent end phenomenon), central untoward reaction such as symptom fluctuates (on-off phenomenon, unusual fluctuation disease), mental symptom.Existing dopaminergic or the treatment of non-dopaminergic are almost invalid to these symptoms.
Clinical research major part about parkinson disease (PD) all is dyskinetic assessment and treats as main object of study both at home and abroad; Discovered in recent years PD patient often is associated with mental disorder like depression, anxiety, cognitive dysfunction, psychotic disease symptom and sleep disorder etc.; These symptoms increase the weight of and directly influence patient's quality of life with PD; In patient's PD while in hospital or after leaving hospital, emotional disturbance, especially depressed; Appreciable impact patient rehabilitation; Depressive state (depression in parkinson disease, PDD) admitted by people already, is to have a strong impact on parkinson patient's the quality of life and the factors of prognosis of disease by its existence.Being shown in the report of nineteen twenty-two Patrick and Levy ' s the earliest about the description of the incidence rate of PDD, is 7%, after this; Foreign literature is to this 4%-70% that is reported as; Slaughter summarizes 45 pieces of documents of 1922-1998, relates to 5991 of patients altogether, and wherein depressive patient is 1835; Incidence rate is 30.6%, and the incidence rate of bibliographical information is 40%-50% mostly recently.The difference of incidence rate is different relevant with patient's selection and source, diagnostic criteria and evaluation and test scale.
The most obvious in PD patient's the non-dyskinesia with sleep disorder, the most common in the sleep disorder with insomnia.Bring serious economy, mental burden for family and society.Result of study shows that the incidence rate of in PD patient, having a sleepless night reaches 68.8%, and in normal elderly population, the prevalence scope of insomnia is 23%-40%.In the form of expression of PD patient's insomnia, it is the highest to keep the obstacle incidence rate with sleep, reaches 65.7%, secondly shortens for total sleep time and the sleep prolongation of latency.Its cause of disease possibly stand up that nocturia increases due to the high reaction of difficulty, bladder for bradykinesia causes, limbs and myalgia, mental state mood change etc., and the seriality of final sleep is suffered to destroy with Sleep architecture and caused having a sleepless night.
The genesis mechanism of concurrent depression of PD and sleep disorder is the coefficient result of multiple factor, promptly has biochemistry, neuro pathology to change, and the social psychology factor is arranged again.PD is a kind of central nervous system's degeneration, and the infringement of any point on the dopaminergic pathway from ventral tegmental area (VTA) to frontal lobe and prefrontal cortex all can cause depressed the generation.Therefore, the dopaminergic path possibly be one of depressed pathogenesis unusually, and 5-hydroxy tryptamine can change, in PD patient is occurred together depressed mechanism, play certain function.Substantia nigra dopaminergic neuron is lost in PD patient's brain, causes the interior mediator of brain unbalance, is the biochemical basis that causes sleep disorder.Night dysfunction can to occur in parkinson disease early stage; Disease causes the night movement obstacle; Especially see with patients with terminal that bradykinesia and myotonia make the patient stand up number of times minimizing or trismus dolorificus night, cause awakening more; Non-motion " pass " phase dependency symptom possibly followed these symptom fluctuations at night, the development of hypnotic obstacle.Periodic leg movements and REM sleep behavior disorder etc. all can influence sleep in anti-Parkinson medicine, Parkinsonian's autonomic nervous function imbalance, restless legs syndrome, the sleep.The medicine of treatment PD such as Dopar (breath is peaceful), dopamine discharge promoter; Majority is prone to cause the untoward reaction such as unusual grade of mental act; More common is uneasy; Insomnia, bad dream and depression etc., cause Sleep efficiency to reduce and the preclinical prolongation types of medicines of sleeping many more, these untoward reaction are easy displaying more just.
At present, do not make things convenient for the patient to take, treat depression and the Chinese medicine patent medicine of sleep disorder in the non-dyskinesia of parkinson disease simultaneously.
Summary of the invention
The problem that the present invention need solve provides a kind of Chinese prescription that improves the Parkinsonian non-dyskinesia like depressed and sleep disorder etc.; This prescription is used for Parkinsonian auxiliary treatment, has the effect of non-dyskinetic depression of anti-Parkinson disease and sleep disorder simultaneously.
A kind of non-dyskinetic pharmaceutical composition of parkinson disease that improves, composed of the following components:
Herba Epimedii extract 1-60 weight portion Herba Cirsii water extract 1-300 weight portion
Liquorice beverage extract 1-300 weight portion Radix Paeoniae Alba alcohol extract 10-600 weight portion
In this prescription:
Herba Epimedii is the warming the kidney to invigorate YANG conventional Chinese medicine, and as the main active of Herba Epimedii, icariin has shown antidepressant effect in multiple classical depression model.Kong Lingdong etc. discover; Herba Epimedii extract (containing icariin 54.56%) can suppress to force the activity of outstanding tail Mouse Liver and cerebral tissue MAOA (MAO-A) and MAO-B (MAO-B). and reverse the rising of murine liver tissue MDA level, the effect of prompting Herba Epimedii extract might be through suppressing the MAO activity and weakening radical pair neural tissue injury degree realization.
At present, (Parkinson disease, PD) main Therapeutic Method is the alternate symptomatic treatment of dopamine to parkinson disease.Monoamine oxidase B inhibitors (MAO-BI) suppresses endogenous through selectivity, specificity and exogenous dopamine decomposes, and prolongs the action time of dopamine, thereby improves clinical symptoms, the auxiliary treatment after can be used for the early stage single therapy of PD and the symptom fluctuation occurring.In addition, preclinical study finds that also MAO-BI has neuroprotective.
Simultaneously, because many merging are depressed in the parkinson disease, and depressive patient neutral function obstacle sickness rate is than higher.Herba Epimedii is as kidney invigorating and YANG supporting Chinese medicine commonly used; People such as Xiong Yuebin are through having studied icariin to the endocrine influence of arrenotoky at the rat testicle Interstitial cell of body mice childhood and isolated culture; Find that icariin can make mouse epididymis and seminal vesicle weightening finish, point out this maybe be relevant with the yang invigorating functions of Herba Epimedii.Simultaneously, through to the pharmacological experiment study of Herba Epimedii, prove that Herba Epimedii all has benefiting action in above-mentioned each side for human body at cardio-cerebrovascular, blood system, immune system, reproductive system, bone marrow system and defying age, anti-tumor aspect.
Radix Glycyrrhizae is a kind of tonification Chinese herbal medicine.Medicinal part is a root and rhizome, and medical material character root is cylindrical, long 25～l00cm, diameter 0.6～3.5cm.The crust degree of tightness differs, the brown or taupe brown of surface red.Rhizome is cylindrical, and there is the bud trace on the surface, and there is marrow at the section middle part.Feeble QI, it is sweet and special to distinguish the flavor of.Function cures mainly heat-clearing and toxic substances removing, expelling phlegm for arresting cough, gastral cavity abdomen etc.Happiness sunlight is abundant, the low dry climate of long temperature at sunshine.Radix Glycyrrhizae is grown in arid, semiarid desert steppe, desert edge and loess hill area more.
Though the definite cause of disease of parkinson morbidity is still unclear at present, research shows that its major lesions is on black substance and striatum dopamine nervous pathway.Because carrying out property of dopamine (DA) serotonergic neuron degeneration in big substantia nigra-striatum system; Cause in the striatal primary motor area territory neurotransmitter dopamine to be exhausted and the cholinergic system activeness is strengthened relatively; Therefore, improving the content of dopamine among the central nervous system or the imbalance of correction dopaminergic nerve and cholinergic nerve two big systemic-functions is starting points of treatment PD.
And the effect of Radix Glycyrrhizae water extract maybe be relevant with the level of regulating NE and DA.Discover; The main active liquirtin of Radix Glycyrrhizae antidepressant effect; It can obviously reverse the infringement of chronic stress to rat behavior, and possibly be to Hippocampal Neurons infringement realization through the peroxidating that improves body superoxide dismutase activity, removing free radical, prevention lipid, the generation that reduces malonaldehyde, reduction chronic stress.
(formal name used at school: Paeonia sterniana Fletcher in Journ.) also claim Paeonia sterniana Fletcher in Journ., be Ranunculaceae Paeonia plant to the Radix Paeoniae Alba.At the existing long cultivation history of China, have won fame both at home and abroad, its root also is used as medicine.Perennial herb or undershrub, underground part is block or slightly thick; Phyllopodium gives birth to or stem is given birth to, and is big, alternate, pinniform or trifoliolate leaf or drastic crack; Spend big and beautiful, singly be born in branch top or bunchy sometimes, white; Sepal 5, deposit the place; Petal 5-10, but normal in cultigen is polyphyll; Stamen is most; Floral disc ring-type or cup-shaped; Carpel 2-5, centrifugal growth, Bian is the Follicle radish in the time of as a result, and each has seed number.Be born in the bushes or thick grass in hillside, mountain valley.Ground such as Chinese Anhui, Heilungkiang, Jilin, Liaoning, Hebei, Henan, Shandong, Shanxi, Shaanxi, the Inner Mongol distribute.
The Radix Paeoniae Alba is a kind of conventional plant amedica.Its cold nature, the liver spleen channel is returned in bitter in the mouth acid.The master contains active ingredients such as peoniflorin, oxypaeoniflorin, lactone glucoside of Radix Paeoniae, paeonol.Has the effect that nourishing blood to suppress the hyperactive liver, slow middle pain relieving, clots absorbing, removing heat from blood, detumescence and yin fluid astringing are received antiperspirant.Clinically be used for that treatment is had a dizzy spell, disease curative effects such as flank pain, limb pain twin are better.
Radix Paeoniae Alba ethanol extract can significantly shorten mice 90, during the dosage of 45mg/kg and force the dead time in outstanding tail and the mice forced swimming test, and tangible dose-effect relationship is arranged; When 45 mg/kg dosage, its effect is compared with fluoxetine has advantage.Peoniflorin and lactone glucoside of Radix Paeoniae might be the effective ingredient of its antidepressant effect in the Radix Paeoniae Alba extract.
Herba Cirsii is the dry aerial parts of feverfew field thistle Cirsium setosum (Wild.) MB., different name cat Ji, blue or green field thistle, thousand needle grass, field thistle dish etc.; Be widely distributed in all over China, Heilongjiang Province's resource is very abundant." its sweet in the mouth of 2005 editions records of Chinese pharmacopoeia, hardship, cool in nature, GUIXIN, Liver Channel; Effect with cooling blood for hemostasis, removing blood stasis to reduce swelling.
Hou Yunfen etc. use Herba Cirsii treatment intractable insomnia, and through clinical practice in 3 years, determined curative effect was not found untoward reaction.Generally taking 15min can fall asleep, hold time more than 8 h, if disrupted sleep or wake up after, no sense of discomfort, do not have influence to thinking and emotion daytime.
Herba Epimedii has the effect of antidepressant, tonifying YANG among this side, and Radix Glycyrrhizae has antidepressant and the effect that improves the parkinson disease symptom, and the Radix Paeoniae Alba has antidepressant effect equally, and little thistle then has the effect of outstanding Cure for insomnia.Because Herba Epimedii has the active effect that suppresses monoamine oxidase, MAO; Through the adjusting of liquirtin to the DA level; Can better bring into play its antidepressant; Improve the non-dyskinetic effect of parkinson disease, reduced and Parkinsonian medicine such as dopamine precursor: levodopa etc. reach the interaction of dopamine-receptor stimulant, have strengthened the effect of antidepressant and anti-sleep disorder.
The specific embodiment
The non-dyskinetic pharmaceutical composition of parkinson disease that improves of the present invention, preferably composed of the following components:
Herba Epimedii extract 1-10 weight portion Herba Cirsii water extract 1-50 weight portion
Liquorice beverage extract 1-50 weight portion Radix Paeoniae Alba alcohol extract 10-100 weight portion
Aforementioned pharmaceutical compositions, more preferably composed of the following components:
Herba Epimedii extract 5.5 weight portion Herba Cirsii water extracts 11 weight portions
Liquorice beverage extract 18 weight portion Radix Paeoniae Alba alcohol extracts 49 weight portions
Wherein, Herba Epimedii extract adopts the Herba Epimedii decocte with water, and medicinal liquid concentrates, and processing proportion is 1.2-1.8g/cm
3Thick paste, add the ethanol precipitate with ethanol, filter, make after filtrating concentrates to be diluted with water to 2-10 times of volume of medical material weight, through D
101Macroporous resin column, working concentration are 20-95 volume % ethanol elution, merge ethanol elution, concentrate, and crushed after being dried promptly gets;
The Herba Cirsii water extract adopts the Herba Cirsii decocte with water, and medicinal liquid concentrates, and processing proportion is 1.5-1.8 g/cm
3Thick paste, crushed after being dried promptly gets;
The liquorice beverage extract adopts the Radix Glycyrrhizae decocte with water, and medicinal liquid concentrates, and processing proportion is 1.5-1.8 g/cm
3Thick paste, crushed after being dried promptly gets;
Radix Paeoniae Alba alcohol extract adopts 40-80 volume % ethanol, reflux, extract,, and merge extractive liquid, concentrates, and crushed after being dried promptly gets.
Adopt the Herba Epimedii extract of aforesaid way preparation, the content of Herba Epimedii total flavones wherein can reach more than 60%, and content Determination of Icariin can be greater than 10%.Adopt the Radix Glycyrrhizae water extract of aforesaid way preparation, wherein, the glycyrrhizic acid in the medical material and the extraction ratio of liquirtin can be greater than 90%, and used water to save industrial resources as the extraction solvent.Peoniflorin has good water-solubility, but it is more to adopt water to carry the gelatinized starch grain, filtration difficulty, and it is on the low side to cause measuring the result.So adopt alcohol extraction comparatively suitable.The Radix Paeoniae Alba alcohol extract of aforesaid way preparation, wherein, content of paeoniflorin is 10-98 weight %.
Aforementioned pharmaceutical compositions can be processed solid preparation and/or liquid preparation; Wherein, solid preparation is selected from one or more in the group of being made up of tablet, granule, capsule, drop pill and soft capsule, and liquid preparation is selected from one or more in the group of being made up of oral liquid, injection and injectable powder.
Aforementioned pharmaceutical compositions is improved the application in the non-dyskinetic medicine of parkinson disease in preparation.For the non-dyskinesia of parkinson disease; Give Western medicine simultaneously clinically or Chinese medicine is treated; Due to the viability that the dyskinesia causes but PDD is not descends; And more point out parkinson disease and depression to have common biochemistry and pathology mechanism; Use antidepressant and the Western medicine that improves sleep in order to improve the Parkinsonian non-dyskinesia, interact, increased the extrapyramidal system untoward reaction of medicine or increased the weight of parkinson symptom with levodopa or dopamine-receptor stimulant.If, can bring certain influence to the treatment of its parkinson symptom so use Western medicine to treat simultaneously for the depression and the sleep disorder of disturbances in patients with Parkinson disease.Will cause that untoward reaction increases, the consequence that the patient can't tolerate.Chinese medicine has the characteristics of wholistic therapy, through the adjustment to the human body yang blood and qi, makes it to improve symptom near balance, has reflected the coordination of the inherent function of human body, therefore is difficult for repeatedly.The characteristics of this treating both the principal and secondary aspects of a disease have Western medicine and are difficult to substituted advantage, and the deficiency and the western medicine that can remedy western medicine have very big complementarity.
Herba Epimedii, little thistle, Radix Glycyrrhizae and Radix Paeoniae are adopted the form of extract in this side.Wherein Herba Epimedii adopts the form of Herba Epimedii extract; Give full play to the antidepressant effect of effective site, reduce the influence at other positions, the Herba Cirsii water extract that same Herba Cirsii is adopted; The Radix Paeoniae Alba adopts ethanol extract all to give full play to the effect of effective site, has reduced the influence at other positions.And this side in use notes the content of effective site, can guarantee drug effect.In practical application, has good effect.
Further describe the present invention below in conjunction with specific embodiment, advantage of the present invention and characteristics will be more clear along with description.But these embodiment only are exemplary, scope of the present invention are not constituted any restriction.It will be understood by those skilled in the art that and down can make amendment with form or replace without departing from the spirit and scope of the present invention, but these modifications and replacing all fall in protection scope of the present invention the details of technical scheme of the present invention.
Embodiment improves the non-dyskinetic tablet of parkinson disease for 1 one kinds
Content Determination of Icariin assay method: use liquid phase analysis method to detect content Determination of Icariin.With PERKIN-EIMER-SH/5C
18Post is an analytical column, and use acetonitrile: water: 36% acetic acid (25:73.5:1.5) is made mobile phase, flow velocity 1.0ml/min, and it is 270nm that UV detects wavelength.
Take by weighing reference substance W
1G uses methanol to be made into reference substance solution, and the area of Liquid Detection icariin is A
1, taking by weighing sample is W
2G, same procedure is made into sample solution, and the area of icariin is A
2, according to icariin content=A
2* W
1* 100%/(A
1* W
2).
The content assaying method of Herba Epimedii total flavones: measure according to the pharmacopeia method, promptly use determined by ultraviolet spectrophotometry.
The content assaying method of glycyrrhizic acid: use liquid phase analysis method to detect the content of the glycyrrhizic acid in the Radix Glycyrrhizae water extract.Use ODS chromatographic column (4.6 mm * 25cm, 5 μ m), detect wavelength 254 nm, detected temperatures is a room temperature, mobile phase methanol: 3% glacial acetic acid is 75/25 (V/V), flow velocity 1.0ml/min, sample size 10 μ L.
The content assaying method of liquirtin: use liquid phase analysis method to detect the content of the liquirtin in the Radix Glycyrrhizae water extract.Chromatographic column is Supelco Discovery (4.6mm * 150mm 5 μ m) C
18Post; Column temperature: room temperature; Mobile phase: 3% glacial acetic acid/acetonitrile (80:20); Flow velocity: 0.8ml/min; Detect wavelength: 276nm, sample size 20 μ l.
The content of paeoniflorin assay method: the liquid phase analysis method detects the content of paeoniflorin in the peonol extract.Chromatographic column Zorbacsb-C
18(4.6 * 150mm, 5 μ m); Mobile phase is acetonitrile: 0.1% phosphoric acid solution (14: 86), and the detection wavelength is 230nm, and flow velocity is 1.0ml/min, and column temperature is a room temperature, sample size 20 μ l.
1, the preparation of Herba Epimedii extract, Herba Cirsii water extract, liquorice beverage extract and Radix Paeoniae Alba alcohol extract
Herba Epimedii extract: get Herba Epimedii 120g, use 2.4L water, decoct 3 times, each 3 hours, merge decocting liquid, concentrate, making proportion is 1.6g/cm
3Thick paste, use 75% ethanol precipitation.Get filtrating, reclaim ethanol, the extractum that is dissolved in water transfers to cumulative volume 960ml, filters the D of filtrating through having handled
101Macroporous resin column, using distilled water and concentration respectively is 90 volume % ethanol elutions, collects 90 volume % ethanol elution, reclaims ethanol, concentrates, crushed after being dried gets Herba Epimedii extract 5.5g, icariin content 21%, Herba Epimedii total flavones content 62%.
The Herba Cirsii water extract: get Herba Cirsii 120g, use 1.4L water, decoct 3 times, each 2 hours, merge decocting liquid, concentrate, making proportion is 1.6g/cm
3Thick paste, use vacuum drying oven, under 800Pa, temperature is 80 ℃, is dried to water content less than 3 weight %, pulverizes, and crosses 60 mesh sieves, obtains Herba Cirsii water extract 11g.
The liquorice beverage extract: extracting liquorice 200g, use 3L water, decoct 3 times, each 2 hours, merge decocting liquid, concentrate, making proportion is 1.6g/cm
3Thick paste, use vacuum drying oven, under 800Pa, temperature is 80 ℃, is dried to water content less than 3 weight %, pulverizes, and crosses 60 mesh sieves, obtains 18g dry powder, glycyrrhizic acid content is 28.2%, liquirtin content is 4.2%.
Radix Paeoniae Alba alcohol extract: get Radix Paeoniae Alba 200g, use 50% ethanol 1.6L, decoct 2 times, each 2 hours, merge alcohol extract, reclaim ethanol, concentrating under reduced pressure, making proportion is 1.58g/cm
3Thick paste, use vacuum drying oven, under 800Pa, temperature is 80 ℃, is dried to water content less than 3 weight %, pulverizes, and crosses 60 mesh sieves, obtains 49g dry powder, paeoniflorin content is 81.63mg/g.
2, has the tablet that improves the non-dyskinesia effect of parkinson disease
2.1 the proportioning of pharmaceutical composition
Herba Epimedii extract 5.5g Herba Cirsii water extract 11g
Liquorice beverage extract 18g Radix Paeoniae Alba alcohol extract 49g
2.2 the preparation of tablet
With Herba Epimedii extract in 2.1, the Herba Cirsii water extract, liquorice beverage extract and Radix Paeoniae Alba alcohol extract mix homogeneously add amylopectin 40g, microcrystalline Cellulose 20g, sodium carboxymethyl cellulose 4g, dextrin 8g pulverizes, and crosses 120 mesh sieves.Use 5% PVP to prepare soft material, granulate, drying, granulate adds magnesium stearate 0.8g, mix homogeneously, tabletting promptly gets, and suppresses 200 altogether, and tablet weight is the 0.75-0.82g/ sheet.
The effect of the depressive symptom of tablet in improving the non-dyskinesia of parkinson disease of preparation among embodiment 2 embodiment 1
1 material and method
1.1 object of study
The diagnosis of PD meets Martila and proposes that two in following four classical symptoms will be arranged at least, i.e. static tremor, hypokinesia, muscular hypertonia and postural reflex obstacle are got rid of symptomatic PD and previously be mentally ill.
1.2 research method
PD patient adopts state of an illness classification and international uniform evaluation criterion of therapeutical effect (UPDS) to evaluate its degree that is in a bad way; Depressed 17 versions of HAMD (HAMD) that adopt; 0～8 fen no depressive symptom, 9～16 are divided into slight depression, 17 be divided in-severe depression; >=16 fens inclusion criterias are got rid of the patient of serious cardiopulmonary, hepatic and renal function pathological changes.Be divided into treatment group and matched group, treatment group income patient 30 examples, matched group income patient 30 examples.
1.3 medicine
The treatment group is used the tablet (every contains Herba Epimedii extract 27.5mg, Herba Cirsii water extract 55mg, liquorice beverage extract 90mg, Radix Paeoniae Alba alcohol extract 245mg) and the conventional PD medication of preparation among the embodiment 1; Matched group does not use any antidepressant drug, uses conventional PD medication.Among the embodiment 1 preparation tablet be oral administration, one day three times, one time 4, fixed dosage.
1.4 evaluation methodology
Before treatment, carry out HAMD scoring and untoward reaction observation the 6th week with the treatment back.
1.5 efficacy evaluation
1. the antidepressant curative effect is divided into recovery from illness, the HAMD minimizing of marking>75%; 2. produce effects, the HAMD minimizing of marking>50%; Effectively, the HAMD scoring reduces>25%; Invalid, HAMD scoring < 25%.All scale evaluations are by accomplishing through the physician after the scale evaluation training.
1.6 untoward reaction is observed
Observe gastrointestinal reaction, hypotension, electrocardiogram and routine blood test, liver, kidney function test.
1.7 statistical method: handle the t check with software SPSS 9.0.
2 experimental results
The preceding variation of marking of table 1 treatment with 6 week of treatment back HAMD
| ? | Before the HAMD treatment | After the HAMD treatment | Comparison before and after the HAMD treatment |
| The treatment group | 24.12±5.89 | 15.31±6.23 | P<0.01 |
| Matched group | 22.45±7.02 | 20.97±7.44 | P>;0.05 |
| T-Text | P>;0.05 | P<0.05 | ? |
Table 2 liang group antidepressant curative effect
| ? | The treatment group | Matched group |
| Recovery from illness | 3 | 0 |
| Produce effects | 15 | 2 |
| Effectively | 8 | 7 |
| Invalid | 4 | 21 |
| Amount to significant figure | 26 | 9 |
| Total effective rate (%) | 86.7 | 30 |
3, conclusion
Can see by above-mentioned 2 forms; Used among the embodiment 1 between the HAMD before and after its treatment of treatment group of tablet of preparation and had significant difference; P 0.01, and HAMD and the HAMD value of matched group after 6 weeks that the treatment group was treated after 6 weeks have significant difference, and P < 0.05.Two groups of antidepressant curative effects, through statistics, total effective rate is respectively 86.7% and 30%, and obvious difference is arranged.The compositions of using in the illustrative embodiment 1 can be improved the depressive state in the non-dyskinesia of parkinson disease, has tangible antidepressant curative effect.
The effect of the sleep disorder of tablet in improving the non-dyskinesia of parkinson disease of preparation among embodiment 3 embodiment 1
1 material and method
1.1 object of study
Physical data: parkinson disease (Hoehn-Yahr divides I level～V level) companion sleep disorder patient 60 examples, wherein male 34 examples, women 26 examples.45 years old～83 years old age (62.25 years old ± 6.70 years old), the course of disease 1.50～12.00 (scholar was 2.65 years in 3.25).Hoben-Yanr classification: I level 4 examples, II level 19 examples. III level 23 examples, IV level 10 examples, V level 4 examples.
Inclusion criteria: all cases all meet (the United Kingdom Parkinson Disease Society of Britain parkinson disease association; UKPDS) diagnostic criteria; Be slow morbidity; Have in 3 symptoms such as static tremor, muscle rigidity and bradykinesia at least 2, levodopa treatment test reacting positive.
Exclusion standard: get rid of parkinson's syndrome and parkinson supraposition syndrome, get rid of other nervous system disease, mental sickness, getting rid of has cognitive disorder and can not the person of scoring.
1.2 research method: the main type of parkinson disease sleep scale (PDSS) evaluation Parkinsonian sleep disorder is insomnia, and wherein difficulty falling asleep 18 examples (30%) are slept and kept difficult 26 examples (43.33%), early awakening 12 examples (20%).Accompany the sleep disorder patient to be divided into two groups parkinson disease, be respectively treatment group and matched group.Wherein treatment group is 30 examples, and matched group is 30 examples.
1.3 medicine
The treatment group is used the tablet (every contains Herba Epimedii extract 27.5mg, Herba Cirsii water extract 55mg, liquorice beverage extract 90mg, Radix Paeoniae Alba alcohol extract 245mg) and the conventional PD medication of preparation among the embodiment 1; Matched group only uses conventional PD medication.Before going into group, two groups of patients all cut out other sedative hypnotic drugs.Among the embodiment 1 preparation tablet be oral administration, one day three times, one time 4, fixed dosage.
1.4 evaluation methodology
PDSS marks and the untoward reaction observation to carrying out with matched group with the treatment group in the 4th week of treatment and the 8th week before treating.
1.5 untoward reaction is observed
Observe gastrointestinal reaction, hypotension, electrocardiogram and routine blood test, liver, kidney function test.
1.7 statistical method: measurement data is represented with mean ± standard deviation, adopts the t check.
2 experimental results
The preceding variation of marking of table 3 treatment with 4 weeks of treatment, 8 week back PDSS
| Scale | n | Before the treatment | Treated for 4 weeks | Treated for 8 weeks |
| The treatment group | 30 | 120.4±19.8 | 130.7±15.6* | 142.1±13.1* |
| Matched group | 30 | 128.3±21.1 | 130.2±17.2 | 131.3±14.4 |
Remarks: after 4 weeks of * treatment group treatment with before the treatment significant difference is arranged relatively
After 8 weeks of treatment group treatment with before the treatment significant difference is arranged relatively
The treatment of treatment group relatively has significant difference with matched group after 8 weeks
3, conclusion
Can see by form 3, used among the embodiment 1 preparation tablet the treatment group its treat 4 weeks, 8 week the back with treatment before PDSS value between have significant difference, and treatment group treatment 4 is all and treat between 8 all PDSS values and have marked difference equally.And matched group does not all have significant difference after treating for 4 weeks and treating for 8 weeks with before treating.Treatment group patient treatment has significant difference with the matched group patient after 8 weeks after 8 weeks.Explaining has positive effect aspect the sleep disorder of tablet in improving the Parkinsonian non-dyskinesia that uses preparation among the embodiment 1.Onset time is short, and the lasting improvement that can bring Parkinsonian's sleep disorder.
Claims (8)
1. one kind is improved the non-dyskinetic pharmaceutical composition of parkinson disease, composed of the following components:
Herba Epimedii extract 1-60 weight portion Herba Cirsii water extract 1-300 weight portion
Liquorice beverage extract 1-300 weight portion Radix Paeoniae Alba alcohol extract 10-600 weight portion.
2. pharmaceutical composition according to claim 1, composed of the following components:
Herba Epimedii extract 1-10 weight portion Herba Cirsii water extract 1-50 weight portion
Liquorice beverage extract 1-50 weight portion Radix Paeoniae Alba alcohol extract 10-100 weight portion.
3. pharmaceutical composition according to claim 2, composed of the following components:
Herba Epimedii extract 5.5 weight portion Herba Cirsii water extracts 11 weight portions
Liquorice beverage extract 18 weight portion Radix Paeoniae Alba alcohol extracts 49 weight portions.
4. according to the pharmaceutical composition of claim 1-3 described in each, wherein:
Herba Epimedii extract adopts the Herba Epimedii decocte with water, and medicinal liquid concentrates, and processing proportion is 1.2-1.8g/cm
3Thick paste, add the ethanol precipitate with ethanol, filter, make after filtrating concentrates to be diluted with water to 2-10 times of volume of medical material weight, through D
101Macroporous resin column, working concentration are the ethanol elution of 20-95 volume %, merge ethanol elution, concentrate, and crushed after being dried promptly gets;
The Herba Cirsii water extract adopts the Herba Cirsii decocte with water, and medicinal liquid concentrates, and processing proportion is 1.5-1.8 g/cm
3Thick paste, crushed after being dried promptly gets;
The liquorice beverage extract adopts the Radix Glycyrrhizae decocte with water, and medicinal liquid concentrates, and processing proportion is 1.5-1.8 g/cm
3Thick paste, crushed after being dried promptly gets;
Radix Paeoniae Alba alcohol extract adopts 40-80 volume % ethanol, reflux, extract,, and merge extractive liquid, concentrates, and crushed after being dried promptly gets.
5. according to the pharmaceutical composition of claim 1-3 described in each, it is characterized in that this pharmaceutical composition processes solid preparation and/or liquid preparation; Wherein, solid preparation is selected from one or more in the group of being made up of tablet, granule, capsule, drop pill and soft capsule, and liquid preparation is selected from one or more in the group of being made up of oral liquid, injection and injectable powder.
6. pharmaceutical composition according to claim 4, wherein this pharmaceutical composition is processed solid preparation and/or liquid preparation; Wherein, solid preparation is selected from one or more in the group of being made up of tablet, granule, capsule, drop pill and soft capsule, and liquid preparation is selected from one or more in the group of being made up of oral liquid, injection and injectable powder.
7. pharmaceutical composition according to claim 5 improves the application in the medicine of depression and/or sleep disorder in the non-dyskinesia of parkinson disease in preparation.
8. pharmaceutical composition according to claim 6 improves the application in the medicine of depression and/or sleep disorder in the non-dyskinesia of parkinson disease in preparation.
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| CN201210259176.XA CN102793760B (en) | 2012-07-25 | 2012-07-25 | Medicinal composition for improving non-dyskinesia of Parkinson disease |
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| CN201210259176.XA CN102793760B (en) | 2012-07-25 | 2012-07-25 | Medicinal composition for improving non-dyskinesia of Parkinson disease |
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| CN102793760B CN102793760B (en) | 2015-04-22 |
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| WO2002102397A1 (en) * | 2001-06-15 | 2002-12-27 | Korea Research Institute Of Chemical Technology | Use of an extract of the root of balloon-flower for preventing and treating a degenerative brain disease or for enhancing memory |
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| CN1739743A (en) * | 2005-01-19 | 2006-03-01 | 广东众生药业股份有限公司 | Medicine for treating parkinson's disease and Parkinson's syndrome and its prepn |
| CA2601790A1 (en) * | 2005-03-25 | 2006-09-28 | Beijing Wonner Biotech Ltd. Co. | A pharmaceutical composition for treating depression and method for preparation thereof |
| CN102343038A (en) * | 2010-12-21 | 2012-02-08 | 陈玉堂 | Medicament for treating cerebrosis such as hemiplegic cerebral palsy, falling sickness, Parkinson, headache, insomnia and the like |
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2012
- 2012-07-25 CN CN201210259176.XA patent/CN102793760B/en active Active
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| WO2002102397A1 (en) * | 2001-06-15 | 2002-12-27 | Korea Research Institute Of Chemical Technology | Use of an extract of the root of balloon-flower for preventing and treating a degenerative brain disease or for enhancing memory |
| CN1460684A (en) * | 2003-06-05 | 2003-12-10 | 张利民 | Epimedium extract and its production method |
| CN1739743A (en) * | 2005-01-19 | 2006-03-01 | 广东众生药业股份有限公司 | Medicine for treating parkinson's disease and Parkinson's syndrome and its prepn |
| CA2601790A1 (en) * | 2005-03-25 | 2006-09-28 | Beijing Wonner Biotech Ltd. Co. | A pharmaceutical composition for treating depression and method for preparation thereof |
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| CN102793760B (en) | 2015-04-22 |
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Inventor after: Ren Wei Inventor after: Zhang Dan Inventor after: Zhang Heng Inventor after: Zhang Ge Inventor before: Su Jianli |
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Effective date of registration: 20170828 Address after: 138000 No. 255, Songyuan Road, Songyuan economic and Technological Development Zone, Jilin Patentee after: Jilin century Hank Pharmaceutical Co., Ltd. Address before: 266061 Shandong, Laoshan, Hongkong East Road, No. Pioneering Park, biological park, room 248, No. 239 Patentee before: Qingdao Wenchuang Science & Technology Co., Ltd. |