CN105031147B - A kind of Chinese medicine composition and its preparation method and application - Google Patents
A kind of Chinese medicine composition and its preparation method and application Download PDFInfo
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Abstract
The invention discloses a kind of Chinese medicine composition.The Chinese medicine composition is made up of following raw materials calculated by weight：187.5 ± 10 parts of cynomorium songaricum, 120 ± 8 parts of Semen Cuscutae, 25 ± 3 parts of Chinese cassia tree, 120 ± 8 parts of Morinda officinalis, 120 ± 8 parts of the Radix Astragali, 150 ± 8 parts of Chinese yam, 25 ± 3 parts of monkshood, 187.5 ± 10 parts of the fruit of Chinese wolfberry, 200 ± 10 parts of Radix Codonopsis, 150 ± 8 parts of barrenwort.Described Chinese medicine composition is significantly improved treat primary thrombocytopenic purpura the effect of.Chinese medicine composition of the present invention has good kidney tonifying, QI invigorating and Wen Yang effects simultaneously, and tired various symptoms tool is improved significantly.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, more particularly it relates to which one kind treats essential thrombocythemia reduction
The Chinese medicine composition of property purpura, while the invention further relates to the preparation method and applications of the Chinese medicine composition.
Technical background
Thrombocytopenic purpura is a kind of common hemorrhagic disease, is characterized in that blood platelet substantially reduces, with skin
Skin mucous membrane purpura, severe patient can have other position bleedings such as nosebleed, Gingival blood oozing, woman in menstrual period amount excessive or it is serious spit blood,
Spit blood, have blood in stool, symptom, the Intracranial hemorrhage such as hematuria are the lethal causes of disease of this disease.Thrombocytopenic purpura is divided into primary
With the class of Secondary cases two.Primary thrombocytopenic purpura is a kind of immunity syndrome, is common hemorrhagic disease, its
Feature is antiplatelet antibody in blood circulation be present, makes platelet destruction excessive, causes purpura, and megacaryocyte is normal in marrow
Or increase, primitivization.It can clinically be divided into acute and chronic two kinds, the two pathogenesis and be presented with dramatically different.Acute
Less than 10 years old children are mainly in, both sexes indifference, are fallen ill more in winter, spring, it is before disease to have virus infection history more, with the upper respiratory tract
Infection, rubella, measles, varicella are in the majority, also can be after vaccine inoculation.Incubation period between infection and purpura is more in 1~3 week.Into
People's acute is rare, often relevant with medicine, and the state of an illness is more serious than children, and onset is hurried, can there is heating, and predominantly skin, mucous membrane goes out
Blood, it is often more serious.Dermatorrhagia is in the petechia to differ in size, skewness, is more using four limbs；Mucosal bleeding has nosebleed epistaxis, tooth
Oulorrhagia, oral cavity periglottis bleeding blister；Often there are alimentary canal, uropoiesis gastrointestinal hemorrhage, eye combination film bleed bottom, a small number of retinal hemorrhages.Ridge
Marrow is intracranialed hemorrhage common, and crural paralysis or intracranial hypertension can be caused to show, can threat to life.Chronic type is relatively conventional, accounts for original
The 80% of hair property thrombocytopenic purpura, mostly 10~40 years old, women was 3~4 times of male.Insidious onset, patient can have
Continued hemorrhage or recurrent exerbation, some show as local hemorrhagic tendency, such as repeated massive epistaxis or menorrhalgia.Petechia and ecchymosis
The skin and mucous membrane at any position can occur, but it is more with distal limbs.Can there are alimentary canal and uropoiesis gastrointestinal hemorrhage.After wound
It may occur in which deep hemotoncus.Intracranial hemorrhage more rare, but can still occur in acute attack.Spleen is occasionally accessible in deep air-breathing.
The cause of disease and pathogenesis of primary thrombocytopenic purpura, are not yet elucidated with so far.Be considered it is a kind of with
Immune relevant disease, acute after Acute viral upper respiratory infection recovery from illness, prompt decrease of platelet with
Immune response to primary infection is relevant.About half can be measured and have antiplatelet antibody in serum in chronic type patient.
Western medical treatment thrombocytopenic purpura and anaphylactoid purpura choice drug are hormones at present, take rear blood platelet one
As can raise, but the side effect of hormone is very very big, can increase many new diseases again while increased platelets counts, as centripetal
Property obesity, hypertension, diabetes, osteoporosis etc., and after hormone decrement, blood platelet can reduce again, still can be repeatedly after drug withdrawal
Breaking-out.Splenectomy surgical risk is big, and patient is difficult to receive in itself.Spleen is human immunity organ, causes patient to be immunized after cutting spleen
Hypofunction, easily cause severe infections, to patient body and mentally bring great pain, cut the recurrence rate after spleen 58%
Left and right.
CN200810115420.9 discloses a kind of Chinese medicine composition being made up of Chinese medicines such as cynomorium songaricums, and it has treatment former
The effects such as hair property thrombocytopenic purpura, but the Chinese medicine composition still has much room for improvement to the good efficiency of the disease treatment.
The content of the invention
The invention aims to overcome the deficiencies in the prior art, there is provided a kind of Chinese medicine composition, the Chinese medicine composition
To treating primary thrombocytopenic purpura significant effect.
It is another object of the present invention to provide the preparation method of the Chinese medicine composition.
Another object of the present invention is to provide the application of the Chinese medicine composition.
The purpose of the present invention is achieved by the following technical programs：
A kind of Chinese medicine composition, the Chinese medicine composition are made up of following raw materials calculated by weight：
187.5 ± 10 parts of cynomorium songaricum, 120 ± 8 parts of Semen Cuscutae, 25 ± 3 parts of Chinese cassia tree, 120 ± 8 parts of Morinda officinalis, the Radix Astragali 120 ± 8
Part, 150 ± 8 parts of Chinese yam, 25 ± 3 parts of monkshood, 187.5 ± 10 parts of the fruit of Chinese wolfberry, 200 ± 10 parts of Radix Codonopsis, 150 ± 8 parts of barrenwort.
Preferably, the Chinese medicine composition is made up of following raw materials calculated by weight：
187.5 parts of cynomorium songaricum, 120 parts of Semen Cuscutae, 25 parts of Chinese cassia tree, 120 parts of Morinda officinalis, 120 parts of the Radix Astragali, 150 parts of Chinese yam, monkshood
25 parts, 187.5 parts of the fruit of Chinese wolfberry, 200 parts of Radix Codonopsis, 150 parts of barrenwort.
Cynomorium songaricum, also known as HERBA CYNOMORII, it is plant cynomorium songaricum Cynomorium songaricum Rupr. dry meat stem.Spring
Season excavates, and removes inflorescence, segment, dries.There is kidney-replenishing, benefiting essence-blood, the effect of relaxing bowel, for waist knee impotence, impotence is slided
Essence, intestinal dryness are just done.
Semen Cuscutae, it is the annual parasitic prehensile herbaceous plant Semen Cuscutae Cuscutachinessis Lam.'s of Convolvulaceae
Mature seed, plant is harvested during autumn fruit maturation, is dried, lay seed, remove impurity.There is tonifying kidney and benefiting sperm, nourish the liver to improve visual acuity, pacify
The effect of tire, for diseases such as caused by liver and kidney deficiency, soreness of waist and knee joint, impotence and seminal emission, frequent urination and enuresis, two eyes dims, fetal irritabilities.
Chinese cassia tree, be canella Chinese cassia tree Cinnamomum cassia Presl. bark, more than autumn strip cultivation 5~
The bark and branch skin of 10 years, dries or dries in the shade, and has a mends fire supporing yang, let the fire back to its origin, eliminating cold to stop pain, the effect of invigorate blood circulation, is used for
Impotence, official are cold, trusted subordinate's crymodynia, cold of insufficiency type vomiting and diarrhea, Amenorrhea, dysmenorrhoea, warming meridians and promoting circulation of qi.
Morinda officinalis, it is madder wort Morinda officinalis Morinda officinalis How. root, whole year can excavate, remove
Fibrous root is removed, is shone to 6 seventy percent dry, gently beats flat, is dried.Have a kidney-replenishing, strengthening the bones and muscles, the effect of wind-damp dispelling, for impotence and seminal emission,
Uterus cold infertile, irregular menstruation, few abdomen crymodynia, arthralgia pain due to rheumatism, muscles and bones impotence.
The Radix Astragali, it is the dry root of legume astragalus mongolicus or Astragalus membranacus, there is invigorating qi for strengthening superficies, hidroschesis detoxification, myogenic, profit
The effect of urine, detumescence.For treating treatment deficiency of vital energy weak, the sinking of qi of middle-jiao, rush down prolapse of the anus for a long time, uterine bleeding of having blood in stool, exterior deficiency spontaneous perspiration, ulcer is difficult to burst,
Burst for a long time and does not holds back, blood deficiency chlorosis, Heat Diabetes, chronic nephritis, albuminuria, diabetes etc..
Chinese yam, it is the rhizome of Dioscoreaceae yam Chinese yam, is excavated after winter cauline leaf is withered, cut root head, cleaned, done
It is dry.Strengthen the spleen and stomach, for treating tired weakness of the spleen and the stomach, diarrhea, body, deficiency of food, abnormal sweating.
Monkshood, for the processed goods of ranunculaceae plant rhizome of Chinese monkshood Aconitum carmichaeli Debx. root, late June
Excavated to early August, remove female root, fibrous root and silt, practised and claim " mud monkshood ".There are recuperating depleted yang, mends fire supporing yang, by wind-cold damp pathogen
The effect of, collapse, cold weak pulse of limb, impotence, Gong Leng, trusted subordinate's crymodynia, cold of insufficiency type vomiting and diarrhea, cold sensation of the genitalia oedema, deficiency of yang diseases caused by external factors, tremble with fear for yang depletion
Arthritis with fixed pain caused by dampness pain, cloudy subcutaneous ulcer sore.
The fruit of Chinese wolfberry, is the ripening fruits of dicotyledon medicine matrimony vine of solanaceae plant, is plucked when summer, autumn fruit maturation, is removed
Carpopodium, put after shady place dries in the air to pericarp and corrugate, then be exposed to the sun to crust is stiff, pulp is soft and produce.There is a tonifying kidney and benefiting sperm, nourishing the liver is bright
Mesh, blood-enriching tranquillizing, promote the production of body fluid to quench thirst, the effect of moistening the lung and relieve the cough, for treating liver-kidney Yin deficiency, soreness and weakness of waist and knees is dizzy, dizzy, blurred vision
More tears, cough due to consumptive disease, quench one's thirst, seminal emission.
Radix Codonopsis, this product are Campanulaceae Radix Codonopsis Codonopsis pilosula (Franch.) Nannf. dry root,
There is the effect of tonifying middle-Jiao and Qi, strengthening spleen and tonifying lung, for spleen and lung weakness, shortness of breath palpitations, anorexia and loose stool, virtual asthma cough, Heat Diabetes.
Barrenwort, it is Berberidaceae plant Epimedium brevicornum Epimedium brevicornum Maxim. drying overground part
Point, summer, autumn cauline leaf are tapped when luxuriant, are removed thick stalk and impurity, are dried or dry in the shade.There are kidney-replenishing, strengthening the bones and muscles, the work(of wind-damp dispelling
Effect, for impotence and seminal emission, muscles and bones impotence, arthralgia pain due to rheumatism, numbness contracture and climacteric hypertension.
Although CN200810115420.9 has been disclosed for the Chinese medicine group being made up of according to a certain percentage above-mentioned 10 taste Chinese medicine
Compound is to treatment primary thrombocytopenic purpura effective percentage up to 90%, but its effective and good efficiency is less than 40%, existing skill
It is also disclosed in art using compound cynomorium Chongji for Treatment primary thrombocytopenic purpura, its obvious effective rate is 45%, good efficiency
30%；Generally speaking, the disclosed formula of prior art has the effect of certain to treatment primary thrombocytopenic purpura, can be with
Patient is broken away from the dependence to hormone, but fail to reach significant effect.
For inventor by studying for a long period of time, compatibility relationship and ratio to above-mentioned formulation of drug, which make repeated attempts, compares hair
It is existing, reduce the monkshood containing alkaloid component, while have adjusted cynomorium songaricum, Radix Codonopsis, barrenwort, Semen Cuscutae, the Radix Astragali, Chinese yam and Chinese holly
The ratio of matrimony vine, using the Chinese medicine composition of formula of the present invention, it can more effectively treat idiopathic thrombocytopenic purple
Purplish or white patches on the skin.Chinese medicine composition of the present invention has good kidney tonifying, QI invigorating and Wen Yang effects, has to tired various symptoms obvious
Improvement result.
One kind made of the Chinese medicine composition tablet, capsule, soft capsule, granule, oral liquid, syrup,
Pill or pill.
The preparation method of the Chinese medicine composition, comprises the following steps：
S1. Chinese cassia tree is extracted into volatile oil, it is standby；
S2. the dregs of a decoction add water to cook 1~5 time with remaining material, and 1~3 hour every time, collecting decoction filtered, and filtrate is concentrated into
Relative density is 1.1~1.25 liquid at 80 DEG C, is let cool, and adds the ethanol that alcohol content is 30~70 volume %, stirs evenly, quiet
Put, take supernatant, reclaim ethanol and be condensed into the clear cream that relative density at 80 DEG C is 1.30~1.35；
S3. volatile oil described in S1 is mixed with clear cream described in S2, the Chinese medicine composition is made.
Preferably, in S2, the dregs of a decoction add 3 decoctions of moisture, 3 hours first times, second and third time each 1 with remaining material
Hour.
Preferably, in S2, the filtrate is concentrated into the liquid that relative density at 80 DEG C is 1.1~1.2.
Preferably, in S2, the alcohol content of the ethanol is 50 volume %.
Preferably, in S2, the relative density at 80 DEG C of the clear cream is 1.32 ~ 1.34.
Preferably, in S2, the solid-liquid ratio of decoction is 1:8~1:10.
The Chinese medicine composition is preparing the application in treating thrombocytopenic purpura medicine.
Compared with prior art, the present invention has the advantages that：
Chinese medicine composition of the present invention, by the compatibility relationship of middle medicine and the adjustment of ratio, significantly improve medicine
Treat primary thrombocytopenic purpura the effect of, good efficiency significantly improves thing, and total effective rate also gets a promotion.This
The described Chinese medicine composition of invention has good kidney tonifying, QI invigorating and Wen Yang effects, has to tired various symptoms and significantly changes
Kind effect.
Embodiment
The present invention is further described with reference to specific embodiment, but embodiment is not limit the scope of the invention.
Test method used in following embodiments is conventional method unless otherwise specified；Used raw material, reagent etc., such as
Without specified otherwise, being can be from the raw material and reagent that routinely the commercial sources such as purchased in market obtain.
In of the invention and embodiment, the monkshood is cooked aconite.
Embodiment 1
Raw material is as follows：
Cynomorium songaricum 197.5g, Semen Cuscutae 128g, Chinese cassia tree 28g, Morinda officinalis 128g, Radix Astragali 128g, Chinese yam 158g, monkshood 28g, Chinese holly
Matrimony vine 197.5g, Radix Codonopsis 210g, barrenwort 158g.
Chinese medicine composition is made as follows：
S1. Chinese cassia tree is extracted into volatile oil, it is standby；
S2. the dregs of a decoction add water to cook 1 time with remaining material, and each solid-liquid ratio is 1:8, decoct 3 hours, collecting decoction, filtration,
Filtrate is concentrated into the liquid that relative density at 80 DEG C is 1.2, lets cool, and adds the ethanol that alcohol content is 30 volume %, stirs evenly, quiet
Put, take supernatant, reclaim ethanol and be condensed into the clear cream that relative density at 80 DEG C is 1.30；
S3. volatile oil described in S1 is mixed with clear cream described in S2, the Chinese medicine composition is made.
Embodiment 2
Raw material is as follows：
Cynomorium songaricum 177.5g, Semen Cuscutae 112g, Chinese cassia tree 22g, Morinda officinalis 112g, Radix Astragali 112g, Chinese yam 142g, monkshood 22g, Chinese holly
Matrimony vine 177.5g, Radix Codonopsis 190g, barrenwort 142g.
Chinese medicine composition is made as follows：
S1. Chinese cassia tree is extracted into volatile oil, it is standby；
S2. the dregs of a decoction add water to cook 5 times with remaining material, and each solid-liquid ratio is 1:10, it is 1 hour every time, collecting decoction,
Filtration, filtrate are concentrated into the liquid that relative density at 80 DEG C is 1.25, let cool, and add the ethanol that alcohol content is 70 volume %, stir
It is even, stand, take supernatant, reclaim ethanol and be condensed into the clear cream that relative density at 80 DEG C is 1.35；
S3. volatile oil described in S1 is mixed with clear cream described in S2, the Chinese medicine composition is made.
Embodiment 3
Raw material is as follows：
Cynomorium songaricum 187.5g, Semen Cuscutae 120g, Chinese cassia tree 25g, Morinda officinalis 120g, Radix Astragali 120g, Chinese yam 150g, monkshood 25g, Chinese holly
Matrimony vine 187.5g, Radix Codonopsis 200g, barrenwort 150g.
Chinese medicine composition is made as follows：
S1. Chinese cassia tree is extracted into volatile oil, it is standby；
S2. the dregs of a decoction add water to cook 3 times with remaining material, and each solid-liquid ratio is 1:9, it is for the first time 3 hours, second, the
It is respectively 1 hour three times, collecting decoction, filtration, it is 1.2 liquid that filtrate, which is concentrated into relative density at 80 DEG C, lets cool, adds containing alcohol
Measure as 50 volume % ethanol, stir evenly, stand, take supernatant, it is 1.32 to reclaim ethanol and be condensed into relative density at 80 DEG C
Clear cream；
S3. volatile oil described in S1 is mixed with clear cream described in S2, the Chinese medicine composition is made.
Embodiment 4
Raw material is same as Example 3.
Chinese medicine composition is made as follows：
S1. Chinese cassia tree is extracted into volatile oil, it is standby；
S2. the dregs of a decoction add water to cook 3 times with remaining material, and each solid-liquid ratio is 1:9, it is 1 hour every time, collecting decoction,
Filtration, filtrate are concentrated into the liquid that relative density at 80 DEG C is 1.1, let cool, and add the ethanol that alcohol content is 30 volume % and stir evenly,
Stand, take supernatant, reclaim ethanol and be condensed into the clear cream that relative density at 80 DEG C is 1.32；
S3. volatile oil described in S1 is mixed with clear cream described in S2, the Chinese medicine composition is made.
Embodiment 5
Raw material is same as Example 3,
Chinese medicine composition is made as follows：
S1. Chinese cassia tree is extracted into volatile oil, it is standby；
S2. the dregs of a decoction add water to cook 3 times with remaining material, and each solid-liquid ratio is 1:10, it is 3 hours every time, collecting decoction,
Filtration, filtrate are concentrated into the liquid that relative density at 80 DEG C is 1.2, let cool, and add the ethanol that alcohol content is 70 volume % and stir evenly,
Stand, take supernatant, reclaim ethanol and be condensed into the clear cream that relative density at 80 DEG C is 1.34；
S3. volatile oil described in S1 is mixed with clear cream described in S2, the Chinese medicine composition is made.
Comparative example 1
Raw material is as follows：
Cynomorium songaricum 120g, Semen Cuscutae 150g, Chinese cassia tree 25g, Morinda officinalis 120g, Radix Astragali 187.5g, Chinese yam 187.5g are attached
Sub- 62.5g, fruit of Chinese wolfberry 150g, Radix Codonopsis 187.5g, barrenwort 187.5g.
Preparation technology is same as Example 3.
Activity experiment：
Zoopery 1
Animal：Kun Ming mice.
Instrument is clamored：721 type spectrophotometers, the analytical instrument factory of Shanghai the 3rd.
Method and result：Each experiment takes 70 mouse, male and female half and half, 20.0 ± 2.0g of body weight, is divided into 7 groups, every group
L0 is only.The g/kg of Chinese medicine composition 4.65 prepared by administration group A gavages embodiment 1, Chinese medicine prepared by administration group B gavages embodiment 2
Composition 4.65g/kg, Chinese medicine composition 4.65g/kg prepared by administration group C gavages embodiment 3, administration group D gavages embodiment 4
The Chinese medicine composition 4.65g/kg of preparation, Chinese medicine composition 4.65g/kg prepared by administration group E gavages embodiment 5., control group A
Gavage physiological saline, Chinese medicine composition 4.65g/kg prepared by control group B gavages comparative example 1, is administered once a day, continuous 7 days.
1. Phagocytosis By The Peritoneal Macrophages In Mice determines
It is administered the 8th day and 3.5% starch Broth solution 1.0ml is injected intraperitoneally per mouse, next day is injected intraperitoneally once again, is spaced
Cervical dislocation puts to death mouse after 5h, every mouse peritoneal injection 5% chicken red blood cell solution 0.5ml, 50min, cuts open the belly and draws abdomen
Liquid 0.5ml drop pieces, Wright's staining, oil mirror observation, calculate phagocytic index.
As a result：The phagocytosis of control group A, control group B, administration group A, administration group B, administration group C, administration group D, administration group E refers to
Number respectively is 3.43 ± 0.66,7.09 ± 0.61,7.80 ± 0.63,7.82 ± 0.61,7.91 ± 0.68,7.86 ±
0.52、7.82±0.54.(as can be seen that compared with blank control group A, control group B, administration group A, administration group B, administration group C,
Administration group D, administration group E show the effect for the phagocytic index for improving Turnover of Mouse Peritoneal Macrophages.Administration group and blank control
The more equal P of group<0.01, there is significant difference),（Compared with control group B, administration group A, administration group B, administration group C, administration group
D, administration group E shows that the phagocytic index of Turnover of Mouse Peritoneal Macrophages is above control group B）, illustrate Chinese traditional medicine composition of the present invention
Thing can significantly improve the phagocytic index of Turnover of Mouse Peritoneal Macrophages, and effect is better than prior art.
2. mouse carbon particle clearance is tested
2min and 20min is quiet after socket of the eye respectively after the 1h after last dose, tail vein injection burnt black ink 0.1ml/10g
Arteries and veins clump takes blood 2ml, is dissolved in the Na of 2ml 0.1%2CO3Shaken up in solution, 721 type spectrophotometers (600nm) measure optical density, meter
Calculate phagocyte imdex K values.
As a result：Control group A, control group B, administration group A, administration group B, administration group C, administration group D, administration group E K values successively
Respectively 0.62 ± 0.19,0.92 ± 0.34,1.26 ± 0.34,1.33 ± 0.21,2.01 ± 0.22,1.32 ± 0.31,1.29
±0.27.(as can be seen that compared with blank control group A, control group B, administration group A, administration group B, administration group C, administration group D, give
Medicine group E shows the effect (P for improving the clear index K values in carbon granules corridor<0.01), compared with control group B, administration group A, administration group
B, administration group C, administration group D, administration group E show the effect for improving the clear index K values in carbon granules corridor.
3. preventing and treating of the Chinese medicine composition of the present invention to essential thrombocytopenia rabbit
Rabbit 64 is taken, is randomly divided into 8 groups, Normal group, model group, the Chinese medicine composition group of the embodiment of the present invention 1
(1.8ml/kg), the Chinese medicine composition group (1.8ml/kg) of embodiment 2, the Chinese medicine composition group (1.8ml/kg) of embodiment 3, embodiment
4 Chinese medicine composition groups (1.8ml/kg), the Chinese medicine composition group (1.8ml/kg) of embodiment 5, the Chinese medicine composition group of comparative example 1
(1.8ml/kg), every group 8, male and female are used in combination.First it is administered 3 days, every rabbit is disposable in ear vein in addition to Normal group within the 4th day
Antiserum 2.5ml is injected, Normal group rabbit injects normal saline, while daily gavage (ig) administration, normal and mould
The capacity distilled water such as type control group, continuous ig 8 days.Measure administration before, injection antiserum after 90 min and the 5th days each rabbits blood
Platelet number and platelet surface associated antibodies PAIgG.
As a result：The result of table 1 shows, compared with normal group, platelet count of the model group rabbit at the min of modeling 90 and the 5th day
It is obvious to reduce；Compared with model group, Chinese medicine composition of the present invention can substantially make the blood platelet of immune thrombocytopenia rabbit
Number recovers to normal range (NR), and by contrasting Chinese medicine composition of the present invention and the Chinese medicine composition of comparative example 1, Chinese traditional medicine composition of the present invention
The positive effect of thing is better than the Chinese medicine composition of comparative example 1.
The Chinese medicine composition of table 1 influences (× 10/L, n=8) to essential thrombocytopenia Rabbit Blood Platelets number
Contrasted with normal group, * * P<0.01,1 group of 1-5 of embodiment of the present invention groups and comparative example, the * P compared with model group<
0.05, embodiment 1-5 groups are compared with 1 group of comparative example, * P<0.05,1 group pair of Chinese medicine composition 1-5 groups of the present invention and comparative example
Than,# P <0.05。
The result of table 2 shows, compared with normal group, 90min and the 5th day model group Rabbit Blood Platelets surface is related after modeling
Antibody is significantly raised, and Chinese medicine composition of the present invention can obviously reduce the level of the platelet surface associated antibodies of rabbit, and pass through
Chinese medicine composition of the present invention and the Chinese medicine composition of comparative example 1 are contrasted, the positive effect of Chinese medicine composition of the present invention is better than comparative example 1
Chinese medicine composition.
Influence (ng/10 of the Chinese medicine composition of table 2 to essential thrombocytopenia Rabbit Blood Platelets surface associated antibodies7
Pl, n=7)
With normal group contrast * * P<0.01, embodiment 1-5 Chinese medicine compositions and the Chinese medicine composition group of comparative example 1, with model
Group compares * P<0.05, embodiment 1-5 Chinese medicine compositions are compared with the Chinese medicine composition of comparative example 1, * P<0.05.
The influence that the Chinese medicine composition of zoopery 2 is acted on mouse anti-reflecting fatigue
The selection of experimental animal：
Select healthy Kunming kind female mice 84,19 ~ 22g of body weight.
Experimental method：
Every batch of animal is randomly divided into negative control group by body weight（Give deionized water）, the Chinese medicine composition group of comparative example 1
Control group, every group 12, oral gavage, 1 times/day, continuous 30 days, after last gives mouse tested material 30min, carry out each finger
Mapping is determined.Walking weight load measure swimming with a load attached to the body experiment：By mouse tail heavy burden 5%, 45cm × 65cm × 40cm ponds are placed in
Went swimming, depth of water 30cm, 25 DEG C ± 0.5 DEG C of water temperature, per 6, pond mouse, record mouse swimming starts to the death time as small
Mouse walking weight load.
Statistical analysisRepresent, compare between group and examined with t, experimental result is as shown in table 3：
Influence of the Chinese medicine composition of table 3 to the mice burden swimming time
Note：Compared with negative control group, * P<0.05, every kilogram of dosage of mouse is adult（Average 60kg）Every kilogram of recommendation
12 times of dosage.From experimental result, Chinese medical extract has the effect of different degrees of fatigue-relieving, with negative control group
Compare, difference has conspicuousness.The effect of embodiment group is more more notable than control group.As fully visible, Chinese medicine composition of the present invention
Fatigue-relieving various symptoms tool improves significantly.
Clinical trial
1 clinical data
1594 are observed altogether, inpatient 606, outpatient 988, are randomly divided into seven groups, the wherein Chinese medicine of embodiment 1
Composition treatment group A 223, the traditional Chinese medicine composition for treating group B 348 of embodiment 2, the traditional Chinese medicine composition for treating group C of embodiment 3
318, the traditional Chinese medicine composition for treating group D 309 of embodiment 4, the traditional Chinese medicine composition for treating group E243 examples of embodiment 5, Ampeptide Elemente treatment
Control group A 51, the traditional Chinese medicine composition for treating control group B102 examples of comparative example 1
Case follows random principle packet, and two groups same together in sex, age, the state of an illness etc. condition, there is comparativity.
2 test methods
This observation is using random packet, positive drug control, single blind viewing test method.
2.1 dosage regimen
2.1.1 test drug
By reagent：The Chinese medicine composition prepared by embodiment 1 ~ 5 is separately added into auxiliary material, and 1000g granules are made.
Comparison medicine：Ampeptide Elemente, the Chinese medicine composition of comparative example 1 add auxiliary material, and 1000g granules are made.
2.1.2 usage and dosage
Test group：Each 20g, 2 times a day, orally.
Control group：5 tablets once for Ampeptide Elemente, 3 times a day, orally.The Chinese medicine composition of comparative example 1, each 20g, 2 times a day,
Orally.
2.1.3 the course for the treatment of：
Treatment group, control group, for a course for the treatment of, observe 3 courses for the treatment of altogether with 1 month.
2.1.4 disturbing factor controls
During observation, variable factor is controlled, guarantee individually takes observation medicine.
3 observational techniques
3.1 health giving quality observation indexs
Hb, Rbc, Bpc are determined.
Platelet-associated antibody PAIgG, PAIgA, PAIgM are determined.
3.2 security observation indexs
General physical examination：Bp, R, P etc..
Three big routine inspections：Blood, urine, feces are conventional.
Hepatic and renal function, Electrocardioscopy.
The observation of 3.3 adverse reactions：Adverse reaction in detail during the medication of the record object of observation after kimonos medicine, and follow the trail of sight
Examine.
4 results and analysis
4.1 curative effect judging standards and its foundation
With reference to " new Chinese medicine treats the guideline of clinical investigations of qi deficiency ", " new Chinese medicine treats the clinic of Blood deficiency
Research guideline ", " new Chinese medicine treats the guideline of clinical investigations of Blood stasis " are formulated.
（1）Good effect：Symptom, sign are obviously improved；More than 91% is reduced before symptom integral is relatively treated after treatment, items check
Index recovers normal.
（2）It is effective：70%~90% is reduced before symptom integral is relatively treated after treatment, every Index for examination recovers just substantially
Often.
（3）It is progressive：36%~69% is reduced before symptom integral is relatively treated after treatment, every Index for examination improves.
（4）It is invalid：Symptom, sign are without improvement；≤ 35% is reduced before symptom integral is relatively treated after treatment, physico-chemical examination is without changing
It is kind.
4.2 treatment groups, control group treatment primary thrombocytopenic purpura the effect of and its compare, be shown in Table 4：
The treatment group of table 4, control group clinic therapeutic effect of syndrome and its compare
From table 4, it can be seen that good efficiency of the Chinese medicine composition of the present invention in treatment primary thrombocytopenic purpura
It is obviously improved, total effective rate has also been lifted, and the credit that taken statistics to data analysis, difference has significant, illustrates treatment
The clinical efficacy of group is substantially better than control group.
Claims (11)
1. a kind of treat thrombocytopenic purpura or antifatigue Chinese medicine composition, it is characterised in that the Chinese medicine composition
It is made up of following raw materials calculated by weight：
187.5 ± 10 parts of cynomorium songaricum, 120 ± 8 parts of Semen Cuscutae, 25 ± 3 parts of Chinese cassia tree, 120 ± 8 parts of Morinda officinalis, 120 ± 8 parts of the Radix Astragali, mountain
150 ± 8 parts of medicine, 25 ± 3 parts of monkshood, 187.5 ± 10 parts of the fruit of Chinese wolfberry, 200 ± 10 parts of Radix Codonopsis, 150 ± 8 parts of barrenwort.
2. Chinese medicine composition according to claim 1, it is characterised in that the Chinese medicine composition is calculated by weight by following
Raw material be made：
187.5 parts of cynomorium songaricum, 120 parts of Semen Cuscutae, 25 parts of Chinese cassia tree, 120 parts of Morinda officinalis, 120 parts of the Radix Astragali, 150 parts of Chinese yam, monkshood 25
Part, 187.5 parts of the fruit of Chinese wolfberry, 200 parts of Radix Codonopsis, 150 parts of barrenwort.
3. tablet, capsule, granule, oral liquid, syrup or ball made of the Chinese medicine composition of claim 1 or 2
Agent.
4. soft capsule or pill made of the Chinese medicine composition of claim 1 or 2.
5. a kind of preparation method of the Chinese medicine composition of claim 1 or 2, it is characterised in that comprise the following steps：
S1. Chinese cassia tree is extracted into volatile oil, it is standby；
S2. the dregs of a decoction add water to cook 1~5 time with remaining material, and 1~3 hour every time, collecting decoction filtered, and filtrate is concentrated into 80 DEG C
Lower relative density is 1.1~1.25 liquid, is let cool, and adds the ethanol that alcohol content is 30~70 volume %, stirs evenly, stands, take
Supernatant, reclaim ethanol and be condensed into the clear cream that relative density at 80 DEG C is 1.30~1.35；
S3. volatile oil described in S1 is mixed with clear cream described in S2, the Chinese medicine composition is made.
6. the preparation method of Chinese medicine composition according to claim 5, it is characterised in that in S2, the dregs of a decoction add with remaining material
3 decoctions of moisture, 3 hours for the first time, for the third time second and each 1 hour.
7. the preparation method of Chinese medicine composition according to claim 5, it is characterised in that in S2, the filtrate is concentrated into 80
Relative density is 1.1~1.2 liquid at DEG C.
8. the preparation method of Chinese medicine composition according to claim 5, it is characterised in that in S2, the alcohol content of the ethanol
For 50 volume %.
9. the preparation method of Chinese medicine composition according to claim 5, it is characterised in that in S2, the clear cream at 80 DEG C
Lower relative density is 1.32 ~ 1.34.
10. the preparation method of Chinese medicine composition according to claim 5, it is characterised in that in S2, the solid-liquid ratio of decoction is 1:
8~1:10。
11. any one of claim 1 or 2 Chinese medicine composition is in treatment thrombocytopenic purpura medicine is prepared or anti-tired
Application in labor medicine.
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Non-Patent Citations (2)
| Title |
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| 复方锁阳冲剂类糖皮质激素样作用的临床观察;刘益新;《中国医药学报》;19941231;第9卷(第1期);第49-50、64页 * |
| 抗运动性疲劳中药研究现状;杜朝辉等;《中国运动医学杂志》;20080331;第27卷(第2期);第260-265页 * |
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