CN106806777A - A kind of pharmaceutical composition for treating antimigraine - Google Patents
A kind of pharmaceutical composition for treating antimigraine Download PDFInfo
- Publication number
- CN106806777A CN106806777A CN201611272376.3A CN201611272376A CN106806777A CN 106806777 A CN106806777 A CN 106806777A CN 201611272376 A CN201611272376 A CN 201611272376A CN 106806777 A CN106806777 A CN 106806777A
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- fine powder
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- medicine
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Abstract
Pharmaceutical composition of antimigraine and preparation method thereof is treated the present invention relates to a kind of, the pharmaceutical composition is made up of the medicine of following weight portion：Cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, folium sennae, bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, when medicine, red halloysite, it is made up of techniques such as alcohol extracting, water extractions, treatment migraineur 100, total effective rate is up to 98%, effect is obvious, and it was found that adverse reaction and toxic and side effect, illustrate that medicine composite for curing migraineur aspect of the present invention is evident in efficacy, with good promotional value.
Description
Technical field
The present invention relates to field of medicine invention, and in particular to a kind of pharmaceutical composition for treating antimigraine and its preparation side
Method.
Background technology
Antimigraine is a kind of common chronic forms vascular conditions, caused by being nerve-vasomotor dysfunction, with
The disease that recurrent exerbation, inclined side or bilatenal headache are characterized, it breaks out bitterly, and pain gesture acutely, with n and V, or extends to facial muscle and arrests
It is anxious numb, have a strong impact on the life quality of patient.The World Health Organization is serious migraine and quadriplegia, phrenoblabia, silly
Stay the chronic functional obstacle disease for being listed as most serious.
Increasingly accelerate the continuous increase with operating pressure with rhythm of life, the incidence of disease of antimigraine shows constantly rising
Trend, it has also become the common disease of puzzlement modern.At present, western countries' migraine attack rate is higher, and about 10% people suffers from
This disease, the women that there are about 30% is tormented by the antimigraine relevant with menstruation, and is difficult to cure.In the U.S., antimigraine year
Illness rate is 11%, wherein, the illness rate of women antimigraine is 17.6%, and male is 6%.In Britain, there is 18.3% women
Male with 7.6% suffers from antimigraine.According to incompletely statistics, the illness rate of China adult antimigraine is up to 7.7%~18.7%,
Wherein female patient is 3~4 times more than male patient, and most onsets are in puberty.
Antimigraine can betide any age, and statistics shows, the incidence of disease of Children with Migraine is about 3% within 3~7 years old；
Separately there are some researches show antimigraine is inseparable with inherent cause, and familial cases account for 34%-90%.
The pathogenesis of antimigraine is extremely complex, and easily recurs.At present, although the medicine and method of antimigraine very
It is many, but curative effect is not highly desirable, also lacks etiotropic treatment means, can only symptomatic treatment, prevention is noted, particularly to controlling long
Intractable patient more, does not also lack effective treatment method.
Therefore, the present inventor have developed a kind of new drug in order to solve the above problems.
The content of the invention
It is an object of the invention to provide a kind of pharmaceutical composition for treating antimigraine.
It is a further object of the present invention to provide a kind of preparation method of the pharmaceutical composition for treating antimigraine.
The present invention provides a kind of pharmaceutical composition for treating antimigraine, the pharmaceutical composition by following weight portion medicine system
Into：Cynomorium songaricum 20-60 parts, Gorgon fruit 15-50 parts, folium callicarpae pedunculatae 10-40 parts, Galanga Galangal Seed 15-60 parts, folium sennae 5-20 parts, bark of tree of heaven 20-50
Part, fringed pink 10-50 parts, pyrrosia lingua 10-45 parts, anisetree bark 20-60 parts, when medicine 15-60 parts, red halloysite 10-50 parts.
Preferably, pharmaceutical composition of the present invention is made up of the medicine of following weight portion：Cynomorium songaricum 25-55 parts, Gorgon fruit
20-45 parts, folium callicarpae pedunculatae 13-37 parts, Galanga Galangal Seed 20-55 parts, folium sennae 7-18 parts, bark of tree of heaven 25-45 parts, fringed pink 15-45 parts, pyrrosia lingua
15-40 parts, anisetree bark 25-55 parts, when medicine 20-55 parts, red halloysite 15-45 parts.
It is further preferred that pharmaceutical composition of the present invention is made up of the medicine of following weight portion：Cynomorium songaricum 30-50
Part, Gorgon fruit 25-40 parts, folium callicarpae pedunculatae 17-33 parts, Galanga Galangal Seed 25-50 parts, folium sennae 9-16 parts, bark of tree of heaven 28-42 parts, fringed pink 20-40
Part, pyrrosia lingua 20-35 parts, anisetree bark 30-50 parts, when medicine 25-50 parts, red halloysite 20-40 parts.
Still more preferably, pharmaceutical composition of the present invention is made up of the medicine of following weight portion：Cynomorium songaricum 35-45
Part, Gorgon fruit 28-36 parts, folium callicarpae pedunculatae 20-30 parts, Galanga Galangal Seed 30-45 parts, folium sennae 11-15 parts, bark of tree of heaven 32-38 parts, fringed pink 25-
35 parts, pyrrosia lingua 23-32 parts, anisetree bark 35-45 parts, when medicine 30-45 parts, red halloysite 25-35 parts.
Still more preferably, pharmaceutical composition of the present invention is made up of the medicine of following weight portion：40 parts of cynomorium songaricum,
32 parts of Gorgon fruit, 25 parts of folium callicarpae pedunculatae, 38 parts of Galanga Galangal Seed, 13 parts of folium sennae, 35 parts of bark of tree of heaven, 30 parts of fringed pink, 28 parts of pyrrosia lingua, anisetree bark 40
Part, when 38 parts of medicine, 30 parts of red halloysite.
Pharmaceutical composition of the present invention also contains pharmaceutically acceptable carrier or diluent.
Pharmaceutical composition of the present invention is solid pharmaceutical preparation or liquid preparation；The solid pharmaceutical preparation is capsule, particle
Agent, tablet, the liquid preparation are oral liquid, spray.
The preparation method of pharmaceutical composition of the present invention is comprised the following steps：By cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed,
Folium sennae, bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, pulverize and sieve when medicine, red halloysite, with pharmaceutically acceptable carrier or diluent
It is well mixed, it is prepared into preparation.
The preparation method of pharmaceutical composition of the present invention is comprised the following steps：
1) red halloysite is ground into fine powder, plus 2-5 times is measured water and soaked 1-3 days, filtering, filtrate concentration dry, pulverize into thin
Powder is standby；
2) folium sennae is soaked in water 0.5-2 hours, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add 3-6 times to measure decocting cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed to boil 2-5 times, each 0.5-2 hours, filtering is closed
And filtrate, filtrate concentrate drying, it is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, when medicine add 3-6 times measure 75% ethanol soak 10-16 hour, filter,
Filtrate concentrate drying, is ground into fine powder standby；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and adds pharmaceutically acceptable carrier or diluent mixing
Uniformly, it is made preparation.
It is further preferred that the preparation method of pharmaceutical composition of the present invention is comprised the following steps：
1) red halloysite is ground into fine powder, plus 3 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 4 times of amounts to boil 3 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 4 times of ethanol of amount 75% to soak 13 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and adds pharmaceutically acceptable carrier or diluent mixing
Uniformly, it is made preparation.
The parts by weight can be unit of weight known to the field of medicaments such as μ g, mg, g, kg.
The implication of amount refers to the weight ratio of medicinal material again.
The pharmaceutically acceptable carrier or diluent refer to the conventional pharmaceutical carrier of pharmaceutical field, selected from filler,
One or more in adhesive, disintegrant, lubricant, surfactant or flavouring.
Wherein described filler is selected from starch, sucrose, lactose, mannitol, sorbierite, xylitol, microcrystalline cellulose or Portugal
Grape sugar etc.；
Described adhesive is selected from cellulose derivative, alginates, gelatin or polyvinylpyrrolidone etc.；
The disintegrant is selected from microcrystalline cellulose, sodium carboxymethyl starch, polyvinylpyrrolidone, low substituted hydroxy-propyl fiber
Element or Ac-Di-Sol；
The lubricant is selected from stearic acid, polyethylene glycol, calcium carbonate, sodium acid carbonate, silica, talcum powder or stearic acid
Magnesium；
The surfactant is selected from neopelex, stearic acid, Pluronic F68, fat
Sorb is smooth or polysorbate (tween) etc. for fat acid；
The flavouring is selected from Aspartame, Sucralose or saccharin sodium.
Beneficial effect of the present invention：
The present invention can reduce Migraine index, the time for shortening Headache attacks duration every month, alleviating headache, reduce head
Pain monthly attack times, reduce platelet aggregation rate, and effective percentage reaches 98%, effect substantially, and do not find adverse reaction with
Toxic and side effect, is the new drug being worthy to be popularized.
Specific embodiment
Following examples are used to illustrate the present invention, but are not limited to the scope of the present invention.
Embodiment 1
Prescription：Cynomorium songaricum 20g, Gorgon fruit 15g, folium callicarpae pedunculatae 10g, Galanga Galangal Seed 15g, folium sennae 5g, bark of tree of heaven 20g, fringed pink 10g, stone
Wei 10g, anisetree bark 20g, as medicine 15g, red halloysite 10g.
Preparation method：
1) red halloysite is ground into fine powder, plus 2 times of amount water soak 1 day, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 0.5 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) decocting of 3 times of amounts is added to boil 2 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 0.5 hour every time, filtering merged filter
Liquid, filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 3 times of ethanol of amount 75% to soak 10 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/9, dress
Enter capsule, be made capsule.
Embodiment 2
Prescription：Cynomorium songaricum 60g, Gorgon fruit 50g, folium callicarpae pedunculatae 40g, Galanga Galangal Seed 60g, folium sennae 20g, bark of tree of heaven 50g, fringed pink 50g, stone
Wei 45g, anisetree bark 60g, as medicine 60g, red halloysite 50g.
Preparation method：
1) red halloysite is ground into fine powder, plus 5 times of amount water soak 3 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 2 hours, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 6 times of amounts to boil 5 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 2 hours every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 6 times of ethanol of amount 75% to soak 16 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/9, dress
Enter capsule, be made capsule.
Embodiment 3
Prescription：Cynomorium songaricum 25g, Gorgon fruit 20g, folium callicarpae pedunculatae 13g, Galanga Galangal Seed 20g, folium sennae 7g, bark of tree of heaven 25g, fringed pink 15g, stone
Wei 15g, anisetree bark 25g, as medicine 20g, red halloysite 15g.
Preparation method：
1) red halloysite is ground into fine powder, plus 3 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 4 times of amounts to boil 3 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 4 times of ethanol of amount 75% to soak 12 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/9, dress
Enter capsule, be made capsule.
Embodiment 4
Prescription：Cynomorium songaricum 55g, Gorgon fruit 45g, folium callicarpae pedunculatae 37g, Galanga Galangal Seed 55g, folium sennae 18g, bark of tree of heaven 45g, fringed pink 45g, stone
Wei 40g, anisetree bark 55g, as medicine 55g, red halloysite 45g.
Preparation method：
1) red halloysite is ground into fine powder, plus 4 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 5 times of amounts to boil 4 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 5 times of ethanol of amount 75% to soak 14 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/9, dress
Enter capsule, be made capsule.
Embodiment 5
Prescription：Cynomorium songaricum 30g, Gorgon fruit 25g, folium callicarpae pedunculatae 17g, Galanga Galangal Seed 25g, folium sennae 9g, bark of tree of heaven 28g, fringed pink 20g, stone
Wei 20g, anisetree bark 30g, as medicine 25g, red halloysite 20g.
Preparation method：
1) red halloysite is ground into fine powder, plus 3 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 4 times of amounts to boil 3 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 4 times of ethanol of amount 75% to soak 13 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/5, mixes
Even, granulation is dried, and whole grain obtains the granule of the application.
Embodiment 6
Prescription：Cynomorium songaricum 50g, Gorgon fruit 40g, folium callicarpae pedunculatae 33g, Galanga Galangal Seed 50g, folium sennae 16g, bark of tree of heaven 42g, fringed pink 40g, stone
Wei 35g, anisetree bark 50g, as medicine 50g, red halloysite 40g.
Preparation method：
1) red halloysite is ground into fine powder, plus 3 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 4 times of amounts to boil 3 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 4 times of ethanol of amount 75% to soak 13 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/5, mixes
Even, granulation is dried, and whole grain obtains the granule of the application.
Embodiment 7
Prescription：Cynomorium songaricum 35g, Gorgon fruit 28g, folium callicarpae pedunculatae 20g, Galanga Galangal Seed 30g, folium sennae 11g, bark of tree of heaven 32g, fringed pink 25g, stone
Wei 23g, anisetree bark 35g, as medicine 30g, red halloysite 25g.
Preparation method：
1) red halloysite is ground into fine powder, plus 3 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 4 times of amounts to boil 3 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 4 times of ethanol of amount 75% to soak 13 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/5, mixes
Even, granulation is dried, and whole grain obtains the granule of the application.
Embodiment 8
Prescription：Cynomorium songaricum 45g, Gorgon fruit 36g, folium callicarpae pedunculatae 30g, Galanga Galangal Seed 45g, folium sennae 15g, bark of tree of heaven 38g, fringed pink 35g, stone
Wei 32g, anisetree bark 45g, as medicine 45g, red halloysite 35g.
Preparation method：
1) red halloysite is ground into fine powder, plus 3 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 4 times of amounts to boil 3 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 4 times of ethanol of amount 75% to soak 13 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/5, mixes
Even, granulation is dried, and whole grain obtains the granule of the application.
Embodiment 9
Prescription：Cynomorium songaricum 40g, Gorgon fruit 32g, folium callicarpae pedunculatae 25g, Galanga Galangal Seed 38g, folium sennae 13g, bark of tree of heaven 35g, fringed pink 30g, stone
Wei 28g, anisetree bark 40g, as medicine 38g, red halloysite 30g.
Preparation method：
1) red halloysite is ground into fine powder, plus 3 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add the decocting of 4 times of amounts to boil 3 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filter, merging filtrate,
Filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, add 4 times of ethanol of amount 75% to soak 13 hours when medicine, filtering, filtrate is dense
It is standby that contracting dry, pulverize into fine powder；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and addition accounts for the starch of well mixed fine powder weight 1/5, mixes
Even, granulation is dried, and whole grain obtains the granule of the application.
In order to further sketch beneficial effects of the present invention, inventor has done clinical test, and experiment follows evidence-based medicine EBM and faces
The basic principle of bed research, intends carrying out clinical research using random packet, the test method of double blind control.
1. case selection
1.1 diagnostic criteria
1.1.1 tcm diagnosis standard：With reference to State Administration of Traditional Chinese Medicine's encephalopathic acute disease cooperative groups formulation in 1992《Head wind
Diagnosis and efficacy assessment standard》
(1) primary symptom：Repeated relapsing headache, the course of disease more than 6 months or at least 5 times breaking-outs.
1. ache that sick position is more to be tossed about in bed to break out or in full headache in head side volume temporo, forehead, temporo top, or left or right.
2. the property of pain is generally and jumps pain, shouting pain, distending pain, dusk pain, secret anguish, or headache such as to split.
3. have a headache sustainable several minutes, a few hours, a couple of days of breaking out every time, the person that also has continued for several weeks can spontaneous remission.
(2) acute or subacute onset, start-stop is variable.
(3) disease hair can have inducement, often have premonitory symptom before the hair of end.
(4) through NC and physics and chemistry, CT, MRI, DSA check can except cranial injury and intracerebral organic disease
Causer.
1.1.2 Western medicine diagnostic criteria：With reference to the antimigraine diagnostic criteria that international head pain association is drafted for 1988.
(plain edition) of absence of aura：
(1) break out at least more than 5 times；
(2) if do not treated, breaking-out every time continues 4~72 hours；
(3) with following characteristics, at least 2：1. it is Unilateral；2. pulsation；3. during degree is or severe (daily life is received
Limit stops)；4. because going upstairs or other similar daily bodies activities and exacerbation of having a headache.
(4) it is at least one of following during breaking out：1. nausea and/or vomiting；2. photophobia and phonophobia
(5) with following characteristics one：1. organic disease foundation has not been pointed out in medical history and physical examination；
2. medical history and physical examination prompting have organic disease foundation, but have been excluded through related laboratory examination；
Although 3. there is certain organic disease, the first attack of antimigraine is with the disease without substantial connection.
There is tendency (typical case) antimigraine
(1) meet following 2, break out at least 2 times.
(2) following characteristics, at least 3 are met：1. have limitation cortex or (and) 1 or 1 of dysfunction of brain stem with
On premonitory symptom；2. at least 1 premonitory symptom, gradually develops, and continues more than 4 minutes, or has two or two of generation in succession
Symptom more than individual；3. premonitory symptom duration ＜ 60 minutes；4. premonitory symptom and Headache attacks Non-intermittent phase.
(3) with following characteristics 1：1. organic disease foundation has not been pointed out in medical history and physical examination；2. medical history and body
Lattice inspection prompting has organic disease foundation, but has been excluded through related laboratory examination；
Although 3. there is certain organic disease, the first attack of antimigraine is with the disease without substantial connection.
1.1.3 CM syndrome differentiation criterion：With reference to reference to State Administration of Traditional Chinese Medicine's encephalopathic acute disease cooperative groups formulation in 1992《Head wind
Diagnosis and efficacy assessment standard》The wind stasis of blood waits diagnostic criteria.
The wind stasis of blood is waited：With the passing of time, recurrent exerbation, stabbing opthalmalgia knife is cut for headache, or jumps pain, and sore spot is fixed and do not moved, insomnia and dreamful sleep, woman
Female's irregular menstruation has clot with stomachache, purplish tongue or band ecchymosis, petechia, and sublingual train of thought is livid purple, and deeptensepulse is puckery or string.
1.1.4 have a headache strength grading：With reference to International Headache association standard in 1988.
I grades：Not bitterly.
II grades：Mild pain, but activity is not influenceed.
III level：Moderate pain, but do not sign off.
IV grades：Moderate pain, it is impossible to activity.
1.2 inclusive criterias
(1) patient's aspiration is participated in and the person that signs Informed Consent Form；
(2) above-mentioned traditional Chinese and western medicine diagnostic criteria is met；
(3) with following one：Seizure frequency at least monthly 3 times, pain degree it is serious, influence working and learning, in the past
Analgesic drug product is failed to respond to any medical treatment or adverse reaction is serious；
(4) wind stasis syndrome standard (there are two deputy director traditional Chinese physicians or more academic title personnel to approve jointly) is met；
(5) age is at 18-70 Sui.
1.3 exclusion standards：
(1) headache that other diseases cause；
(2) severe cardiac, liver, kidney diaseases, gestation or women breast-feeding their children；
(3) allergic constitution or (and) have drug allergy history person；
(4) being unwilling, receiving research measure or other reasonses is unable to partner；
(5) specific type of antimigraine, such as ophthalmoplegic migraine, hemiplegia type antimigraine；
(6) age was under-18s or more than 70 years old.
1.4 subjects exit the condition of experiment
What 1.4.1 researcher determined exits
(1) during clinical test, subject there occurs the change of some complication, complication or special physiological, uncomfortable
The person that preferably continues reception test；
(2) subject's compliance is poor, influences validity and security judgement person；
(3) in double-blind trial, unblinding or blind situation is promptly taken off.
1.4.2 subject voluntarily exits experiment
According to the regulation of Informed Consent Form, subject has the right to drop by the wayside experiment, though or subject not yet explicitly proposition is exited
Experiment, but no longer receives medication and detection and lost to follow-up, and these situations should also count the case that exits or come off.Should understand as far as possible
The reason for it is exited, can be divided into conscious unsatisfactory curative effect, adverse reaction is difficult to stand, economic problems, other reasonses can not continue
Reception test, undeclared reason etc., and recorded.
2nd, case source
Outpatient service and inpatient of the case from three hospitals such as our hospital.
3rd, group technology
Using multicenter, stratified random, the method for designing of double blind controling test.Selection migraineur 200, is divided into and controlling
Treatment group, placebo, carry out clinical observation.Using random, double blinding, the method for placebo, double blind random table by special messenger's design and
Control, and carry out whole end take off it is blind and statistics.Age, sex, family history, trauma history, medication history, merging tendency to being selected in patient
Situations such as symptom is layered, balanced management.
3.1 estimation of sample size
Estimated as sample size using " to two difference of sample rate, the size table of sample size needed for the meaning that takes statistics inspection "
Calculate, and estimated case depigmentation rate is 20%, this experiment about needs case 200.
3.2 random devices
The research method compareed using completely random, table of random number is produced with SAS8.0 software programmings, according to what is produced
Table of random number and case include order and are divided into control group and treatment group patient respectively.
After 150 patients are by 1: 1: 1 pro rate to three centers, each center selects 1 outside agency's keeping password
Envelope be randomly assigned card, when Eligible subjects enter to be studied, sequence number identical envelope is taken apart in their order, according to wherein blocking
The packet of piece regulation is treated, and must not make any change.
3.3 contrast methods
Because lacking the Chinese medicine preparation of energy rapid-onset at present, this research uses blank.
3.4 blind
Using double-blind study, this development test group is identical with the liquid color of control group, packaging, and dose is equal, and administration
Approach, method, number of times, consumption are consistent.Random cipher envelope is managed by custodian, after opening envelope decision packet, custodian association
Medicine is given in the case of secrecy clinical observation librarian use with Drug monitoring personnel.It is (non-that each center sets a supervisor
The professional not in the know of seminar), supervisor's supervision sets the implementation management of blind process and blind, and clinical research is not participated in directly
Observation and Data Collection.Each center sets the full-time efficacy evaluation served as by the professional and technical personnel with statistical theory knowledge
Personnel (non-subject study personnel), are responsible for evaluation curative effect.After clinical research terminates and completes data statistic analysis, by random cipher
Custodial staff carries out taking off blind.Taking off blind process should have Subject Design people, researcher, supervisor, efficacy evaluation person and store keeping
Director is on the scene.
4th, treatment method
4.1 medicines：Treatment group's medicine of the present invention；
Control group blank, using external packing same with medicine of the present invention, same quality, same dose of placebo.
4.2 administrated methods：Two groups of cases are using oral administration, the pharmaceutical composition of the embodiment of the present invention 1,3g/ times, one day
3 times, share medicine 20 days.Give medicine during Headache attacks temporarily respectively, and record onset time and headache extinction time.Treatment
Period prohibits the use of other treatment medicine, such as analgestic, sedative, calcium ion antagonist, ergotamine preparation.
5th, observation index
5.1 safety observations：
(2) blood, urine, feces routine test and Liver and kidney function inspection, each 1 time before and after treatment；
(3) adverse reaction.
5.2 health giving qualities are observed：
(1) Migraine index；
(2) platelet aggregation rate
(3) brain blood flow is observed through cranium Doppler (TCD)；
(4) after times of headache, degree, duration, administration headache relief time；
6th, Outcome measure
6.1 efficacy evaluations use point-score：(with reference to the Ministry of Public Health《New Chinese medicine treats antimigraine guideline of clinical investigations》
Antimigraine point system)
Primary part observation times of headache, degree, the duration, while observe simultaneous phenomenon.
(1) times of headache：Calculated with the moon, it is 6 points monthly to break out more than 5 times, and 3 times -5 times is 4 points, is 2 less than 2 times
Point.
(2) headache degree：It is 6 points that need to be liied in bed during breaking-out, and it is 4 points that work is influenceed during breaking-out, and it is 2 not influence work during breaking-out
Point.
(3) have a headache the duration：Continue more than 2 days for 6 points, continue to be within 12-48 hours 4 points, the duration is small less than 12
When be 2 points.
6.2 total effectses evaluation criteria are (with reference to the Ministry of Public Health《New Chinese medicine treats antimigraine guideline of clinical investigations》Inclined head
Pain point system) use Nimodipine method：
[integration before (being integrated after integration-treatment before treatment)/treatment] × 100%
(1) clinical recovery：The course for the treatment of terminates without paroxysmal hemicrania symptom, and drug withdrawal is not recurred for 1 month.
(2) it is effective：Integrated after treatment and reduce more than 50%.
(3) effectively：Integrated after treatment and reduce 21%-50%.
(4) it is invalid：Integrated after treatment and reduce less than 20%.
7th, statistical analysis
All data are input into IBM/PC microcomputers, use dBASE data base administrations, data analysis 6.12 editions softwares of SAS,
Grouped data is checked with X2, and ranked data are analyzed with Ridit, and all measurement datas are using t inspections (being represented with X ± S).
8th, subjects interest protection
This research follow Declaration of Helsinki (in October, 2000 Edinburg version) clinical research test specification relevant with China,
Regulation is performed.Clinical Study Protocol can be implemented through testing after the Ethics Committee of responsible department ratifies.
Before each subject enrollment, researcher must complete to subject, comprehensively introduce the purpose of research, degree and can
The risk of energy.Subject is allowed to know that he has the right to exit at any time experiment without being made reprisals.Every subjects signed portion is asked before selected
Informed Consent Form.
9th, quality control and guarantee
Give training before the study, be to participate in researcher research approach and indices content are fully understood and recognized
Know, for the indices for specifying, the time and method that should specify according to scheme are checked, it should be noted that observation adverse reaction
Or unexpected fortuitous event.Each central task is inspected periodically, confirms that the implementation status of various indexs, confirmation scheme are implemented to reach
To appraisal standards, the authenticity and integrity of inspection record, and check that subjects interest protects situation.
10th, result
The medicine group of the present invention of table 1 treats the change of front and rear Migraine index with placebo
Compare * P ＜ 0.01 with placebo, and compare ☆ P ＜ 0.01 before treatment.
Table 2 treats the front and rear Headache attacks every month duration
Compare * P ＜ 0.05 with placebo, and compare ☆ P ＜ 0.05 before treatment.
The time of headache relief after the treatment of table 3
Compare * P ＜ 0.01 with placebo, and compare ☆ P ＜ 0.01 before treatment.
Table 4 treats front and rear headache monthly attack times
Compare * P ＜ 0.01 with placebo, and compare ☆ P ＜ 0.01 before treatment.
Observation before and after the treatment of the platelet aggregation rate of table 5
Compare * P ＜ 0.01 with placebo, and compare ☆ P ＜ 0.01 before treatment.
The clinical total effectses of table 6 compare (number of cases)
It is of the invention to reduce Migraine index, shorten Headache attacks duration every month, alleviate headache to sum up with described
Time, headache monthly attack times are reduced, reduce platelet aggregation rate, effective percentage reaches 98%, and effect substantially, and does not find
Adverse reaction and toxic and side effect, are the new drugs being worthy to be popularized.
Although above having used general explanation, specific embodiment and experiment, the present invention is made to retouch in detail
State, but on the basis of the present invention, some modifications or improvement can be made to it, this is to those skilled in the art aobvious and easy
See.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to claimed
Scope.
Claims (10)
1. a kind of pharmaceutical composition for treating antimigraine, it is characterised in that the pharmaceutical composition by following weight portion medicine system
Into：Cynomorium songaricum 20-60 parts, Gorgon fruit 15-50 parts, folium callicarpae pedunculatae 10-40 parts, Galanga Galangal Seed 15-60 parts, folium sennae 5-20 parts, bark of tree of heaven 20-50
Part, fringed pink 10-50 parts, pyrrosia lingua 10-45 parts, anisetree bark 20-60 parts, when medicine 15-60 parts, red halloysite 10-50 parts.
2. pharmaceutical composition according to claim 1, it is characterised in that the pharmaceutical composition by following weight portion medicine
It is made：Cynomorium songaricum 25-55 parts, Gorgon fruit 20-45 parts, folium callicarpae pedunculatae 13-37 parts, Galanga Galangal Seed 20-55 parts, folium sennae 7-18 parts, bark of tree of heaven 25-
45 parts, fringed pink 15-45 parts, pyrrosia lingua 15-40 parts, anisetree bark 25-55 parts, when medicine 20-55 parts, red halloysite 15-45 parts.
3. pharmaceutical composition according to claim 2, it is characterised in that the pharmaceutical composition by following weight portion medicine
It is made：Cynomorium songaricum 30-50 parts, Gorgon fruit 25-40 parts, folium callicarpae pedunculatae 17-33 parts, Galanga Galangal Seed 25-50 parts, folium sennae 9-16 parts, bark of tree of heaven 28-
42 parts, fringed pink 20-40 parts, pyrrosia lingua 20-35 parts, anisetree bark 30-50 parts, when medicine 25-50 parts, red halloysite 20-40 parts.
4. pharmaceutical composition according to claim 3, it is characterised in that the pharmaceutical composition by following weight portion medicine
It is made：Cynomorium songaricum 35-45 parts, Gorgon fruit 28-36 parts, folium callicarpae pedunculatae 20-30 parts, Galanga Galangal Seed 30-45 parts, folium sennae 11-15 parts, bark of tree of heaven
32-38 parts, fringed pink 25-35 parts, pyrrosia lingua 23-32 parts, anisetree bark 35-45 parts, when medicine 30-45 parts, red halloysite 25-35 parts.
5. pharmaceutical composition according to claim 4, it is characterised in that the pharmaceutical composition by following weight portion medicine
It is made：40 parts of cynomorium songaricum, 32 parts of Gorgon fruit, 25 parts of folium callicarpae pedunculatae, 38 parts of Galanga Galangal Seed, 13 parts of folium sennae, 35 parts of bark of tree of heaven, 30 parts of fringed pink, stone
28 parts of Wei, 40 parts of anisetree bark, when 38 parts of medicine, 30 parts of red halloysite.
6. the pharmaceutical composition according to claim any one of 1-5, it is characterised in that the pharmaceutical composition also contains pharmacy
Upper acceptable carrier or diluent.
7. pharmaceutical composition according to claim 6, it is characterised in that described pharmaceutical composition is solid pharmaceutical preparation or liquid
Preparation；The solid pharmaceutical preparation is capsule, granule, tablet, the liquid preparation are oral liquid, spray.
8. a kind of method for preparing the pharmaceutical composition described in claim any one of 1-5, it is characterised in that the method include with
Lower step：By cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, folium sennae, bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, when medicine, red halloysite crush
Sieving, is well mixed with pharmaceutically acceptable carrier or diluent, is prepared into preparation.
9. a kind of method for preparing claim 1-5 any one described pharmaceutical compositions, it is characterised in that the method includes following
Step：
1) red halloysite is ground into fine powder, plus 2-5 times is measured water and soaked 1-3 days, filtering, filtrate concentration dry, pulverize into fine powder standby
With；
2) folium sennae is soaked in water 0.5-2 hours, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) add 3-6 times to measure decocting cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed to boil 2-5 times, each 0.5-2 hours, filtering merges filter
Liquid, filtrate concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, when medicine add 3-6 times measure 75% ethanol soak 10-16 hour, filter, filtrate
Concentrate drying, is ground into fine powder standby；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and adds pharmaceutically acceptable carrier or diluent mixing equal
It is even, it is made preparation.
10. the preparation method of pharmaceutical composition according to claim 9, it is characterised in that the method is comprised the following steps：
1) red halloysite is ground into fine powder, plus 3 times of amount water soak 2 days, filtering, filtrate concentration dry, pulverize into fine powder standby；
2) folium sennae is soaked in water 1 hour, is filtered, filtrate concentration dry, pulverize into fine powder, standby；
3) decocting of 4 times of amounts is added to boil 3 times cynomorium songaricum, Gorgon fruit, folium callicarpae pedunculatae, Galanga Galangal Seed, 1 hour every time, filtering, merging filtrate, filtrate
Concentrate drying, is ground into fine powder standby；
4) by bark of tree of heaven, fringed pink, pyrrosia lingua, anisetree bark, when medicine adds 4 times of ethanol of amount 75% to soak 13 hours, filtering, filtrate concentration is dry
It is dry, it is ground into fine powder standby；
5) by step 1) 2) 3) 4) standby fine powder is well mixed, and adds pharmaceutically acceptable carrier or diluent mixing equal
It is even, it is made preparation.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106668762A (en) * | 2016-12-12 | 2017-05-17 | 金乡县金醫堂保健食品有限公司 | Traditional Chinese medicinal preparation with effect of removing chloasma, sore-toxin and acnes |
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| CN1559591A (en) * | 2004-03-10 | 2005-01-05 | 山东中医药大学 | Medicine for treating hemicrania |
| CN105213690A (en) * | 2015-11-10 | 2016-01-06 | 张在芬 | One treats migrainous Chinese medicine composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106668762A (en) * | 2016-12-12 | 2017-05-17 | 金乡县金醫堂保健食品有限公司 | Traditional Chinese medicinal preparation with effect of removing chloasma, sore-toxin and acnes |
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