(3) summary of the invention
[problem that will solve]
One of purpose of the present invention just provides a kind of Chinese medicine composition for the treatment of epileptics, and this Chinese medicine composition is the outbreak of Taking Control of Epilepsy disease effectively, and at a specified future date do not have bounce-back, and have no side effect.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
[technical scheme]
The inventor is through clinical practice for many years and experimental study, think that the basic pathogeny of epileptics is that wind, fire, expectorant three are for high, and expectorant turbidly closes thinking for suffering from, covering, scurries away due to the passages through which vital energy circulates, so founded relieving convulsion relieving dizziness, high fever, infantile convulsions, epilepsy, etc., the treatment rule of waking up the patient from unconsciousness by dissipating phlegm, prescription in addition under the guidance of this treatment rule.
Chinese medicine composition of the present invention comprises the raw material of following weight parts:
Rhizoma Gastrodiae 30-90 part Arisaema Cum Bile 60-100 part Radix Polygalae 60-110 part
Herba Lophatheri 30-90 part Radix Ginseng 10-40 part Rhizoma Acori Graminei 130-170 part
Bulbus Fritillariae Cirrhosae 20-50 part Scorpio 30-90 part Rhizoma Zingiberis Recens 50-70 part
Borneolum Syntheticum 5-20 part Bombyx Batryticatus 70-100 part Radix Salviae Miltiorrhizae 90-120 part
Radix Ophiopogonis 80-100 part succinum 20-50 part artificial Calculus Bovis 8-20 part.
The consumption proportion of described raw material is preferably:
90 parts of 90 parts of Radix Polygalaes of 60 parts of Arisaema Cum Bile of Rhizoma Gastrodiae
150 parts of 30 parts of Rhizoma Acori Graminei of 60 parts of Radix Ginsengs of Herba Lophatheri
60 parts in 60 portions of Rhizoma Zingiberis Recenss of 30 portions of Scorpios of Bulbus Fritillariae Cirrhosae
100 parts of 90 parts of Radix Salviae Miltiorrhizaes of 10 parts of Bombyx Batryticatus of Borneolum Syntheticum
15 parts of 30 parts of artificial Calculus Boviss of 90 parts of succinums Radix Ophiopogonis.
The source of the Chinese crude drug that above-mentioned embodiment is mentioned is as follows:
1, Rhizoma Gastrodiae: be the dry tuber of orchid Rhizoma Gastrodiae, tool suppressing the hyperactive liver to relieve the wind syndrome relieving convulsion, the effect of suppressing the hyperactive liver and subsiding YANG.
2, Arisaema Cum Bile:, or process through fermentation for Arisaema Cum Bile fine powder and cattle, sheep, pig for fine powder and cattle, sheep or the Fel Sus domestica of Rhizoma Arisaematis (processed) processes from strand.Removing heat-phlegm is arranged, the effect of dispelling wind and relieving convulsion.
3, Radix Polygalae: be the root of milk wort Radix Polygalae.The Fructus Alpiniae Oxyphyllae of calming the nerves is arranged, eliminate the phlegm, the repercussive effect.
4, Herba Lophatheri: be the dry stem and leaf of Herba Lophatheri.Clearing heat and relieving fidgetness is arranged, the effect of diuresis.
5, Radix Ginseng: be the dry root of Araliaceae Radix Ginseng.Big complement blood is arranged, nourishing blood to promote the production of body fluid, the effect of the mind calming and mentality promoting.
6, Rhizoma Acori Graminei: be the dry rhizome of acorus gramineus araceae plant.Resuscitation inducing and mind tranquilizing is arranged, the effect of removing dampness appetizing.
7, Bulbus Fritillariae Cirrhosae: be the dry bulb of liliaceous plant Bulbus Fritillariae Cirrhosae.Clearing heat and moistening lung are arranged, the effect of preventing phlegm from forming and stopping coughing.
8, Scorpio: be the dry body of Buthidae animal Scorpio.The wind of suffering from spasmolytic is arranged, dispersing pathogen accumulation, the effect of removing obstruction in the collateral to relieve pain.
9, Rhizoma Zingiberis Recens: be the fresh rhizome of zingiber.The cold expelling of inducing sweat is arranged, warming middle-JIAO to arrest vomiting, the effect of preventing phlegm from forming and stopping coughing.
10, Borneolum Syntheticum: be the process of resin product of Dipterocarpaceae plant borneo camphor tree.The refreshment of having one's ideas straightened out is arranged, the effect of clearing away heat to alleviate pain.
11, Bombyx Batryticatus: the larva that is the insecticide silkworm 4-5 of silkworm pretty young woman section age infects, muscardine and lethal dry polypide.Expelling wind to relieve convulsion is arranged, the effect of dissipating phlegm and resolving masses.
12, Radix Salviae Miltiorrhizae: be the dry bucket and the rhizome of labiate Radix Salviae Miltiorrhizae.Blood circulation promoting and blood stasis dispelling is arranged, removing heat from blood eliminating carbuncle, the effect of nourishing blood to tranquillize the mind.
13, Radix Ophiopogonis: be the dry tuber of liliaceous plant dwarf lilyturf.YIN nourishing and the production of body fluid promoting is arranged, the effect that lung moistening clears away heart-fire.
14, succinum: the resin for the taxodiaceae plant in ancient times is transformed under the burial ground year in year out for a long time.Mind tranquilizing and the heart calming is arranged, the effect for the treatment of stranguria blood stasis dispelling.
15, artificial Calculus Bovis: be to form by the cholic acid of cattle and Fel Sus domestica, cholesterol, bilirubin, inorganic salt etc.Have to clear away heart-fire, eliminating phlegm is had one's ideas straightened out, cool liver, endogenous wind stopping, antidotal effect.
Above-mentioned prescription of the present invention can directly be pulverized or be refining as the active component for the treatment of epilepsy medicament through the extraction of the conventional extractive technique in this area such as decoction and alcohol sedimentation technique or ethanol extract from water precipitation.Described active component can be made various pharmaceutical formulations such as powder, pill, tablet, oral liquid, granule, capsule, injection or the like with pharmaceutically acceptable carrier or excipient composition.Wherein said pharmaceutically acceptable carrier or excipient are selected according to different dosage forms.These used carriers or excipient can determine for the those of ordinary skill of pharmaceutical field.
Active ingredient in pharmaceutical of the present invention can prepare according to following three kinds of methods:
First method comprises the steps: to take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Other is ground into fine powder except that artificial Calculus Bovis, Borneolum Syntheticum carefully grind with above-mentioned Chinese crude drug; Above-mentioned whole fine powders are being pressed described mixed evenly as active component.Then above-mentioned active component is made various dosage forms with pharmaceutically acceptable excipient.
Second method comprises the steps: to take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Get succinum, Scorpio, Radix Ginseng, Bombyx Batryticatus earlier and be crushed to 120 purpose fine powders; Again Rhizoma Gastrodiae, Arisaema Cum Bile, Radix Polygalae, Herba Lophatheri, Rhizoma Acori Graminei, Bulbus Fritillariae Cirrhosae, Rhizoma Zingiberis Recens, Radix Salviae Miltiorrhizae, Radix Ophiopogonis are decocted with water secondary, each 2 hours, merge and decoct, obtain extracting solution and filtration, the gained extracting solution is condensed into thick paste, adds above-mentioned fine powder, mixing, drying and crushing to 120 purpose fine powder carefully grinds artificial Calculus Bovis, Borneolum Syntheticum again; Above-mentioned whole fine powders are pressed described mixed evenly as active component; Above-mentioned active component is made various dosage forms with pharmaceutically acceptable excipient.
The third method comprises the steps: to take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Other is ground into coarse powder except that artificial Calculus Bovis, Borneolum Syntheticum carefully grind with above-mentioned Chinese crude drug, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, drying is ground into fine powder; Above-mentioned whole fine powders are pressed described mixed evenly as active component.Make various dosage forms as active component with pharmaceutically acceptable excipient with above-mentioned.
[beneficial effect]
Pharmaceutical composition of the present invention has relieving convulsion relieving dizziness, high fever, infantile convulsions, epilepsy, etc., the waking up the patient from unconsciousness by dissipating phlegm effect.The total effects of the pharmaceutical treatment epileptics of making as active component with said composition powder or its extract is 64.7%.Through acute and long term toxicity test, be increased to usual amounts and show for 200 times and have no side effect.How tame the preparation that experiment showed, pharmaceutical composition of the present invention through hospital's more than ten years clinical research be fairly obvious to the epileptics curative effect, total effective rate nearly 98%.
(4) specific embodiment
Further describe the present invention by embodiment and test example down.
Embodiment 1: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
90 parts of 90 parts of Radix Polygalaes of 60 parts of Arisaema Cum Bile of Rhizoma Gastrodiae
150 parts of 30 parts of Rhizoma Acori Graminei of 60 parts of Radix Ginsengs of Herba Lophatheri
60 parts in 60 portions of Rhizoma Zingiberis Recenss of 30 portions of Scorpios of Bulbus Fritillariae Cirrhosae
100 parts of 90 parts of Radix Salviae Miltiorrhizaes of 10 parts of Bombyx Batryticatus of Borneolum Syntheticum
15 parts of 30 parts of artificial Calculus Boviss of 90 parts of succinums Radix Ophiopogonis
Chinese medicine artificial Calculus Bovis, Borneolum Syntheticum carefully are ground into fine powder respectively; All the other Chinese crude drugs are dried and crushed into fine powder;
With above-mentioned whole fine powder mix homogeneously, make.
Embodiment 2: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
90 parts of 90 parts of Radix Polygalaes of 60 parts of Arisaema Cum Bile of Rhizoma Gastrodiae
150 parts of 30 parts of Rhizoma Acori Graminei of 60 parts of Radix Ginsengs of Herba Lophatheri
60 parts in 60 portions of Rhizoma Zingiberis Recenss of 30 portions of Scorpios of Bulbus Fritillariae Cirrhosae
100 parts of 90 parts of Radix Salviae Miltiorrhizaes of 10 parts of Bombyx Batryticatus of Borneolum Syntheticum
15 parts of 30 parts of artificial Calculus Boviss of 90 parts of succinums Radix Ophiopogonis
Chinese crude drug succinum, Scorpio, Radix Ginseng, Bombyx Batryticatus are crushed to 120 purpose fine powders; Secondary will be decocted with water Chinese crude drug Rhizoma Gastrodiae, Arisaema Cum Bile, Radix Polygalae, Herba Lophatheri, Rhizoma Acori Graminei, Bulbus Fritillariae Cirrhosae, Rhizoma Zingiberis Recens, Radix Salviae Miltiorrhizae, Radix Ophiopogonis, each 2 hours, merge and decoct, obtain extracting solution and filtration, the gained extracting solution is condensed into thick paste, add above-mentioned fine powder, mixing drying and crushing to 120 purpose fine powder carefully is being ground into fine powder respectively with Chinese medicine artificial Calculus Bovis, Borneolum Syntheticum; Above-mentioned whole fine powders are even by described mixed, make.
Embodiment 3: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
90 parts of 90 parts of Radix Polygalaes of 60 parts of Arisaema Cum Bile of Rhizoma Gastrodiae
150 parts of 30 parts of Rhizoma Acori Graminei of 60 parts of Radix Ginsengs of Herba Lophatheri
60 parts in 60 portions of Rhizoma Zingiberis Recenss of 30 portions of Scorpios of Bulbus Fritillariae Cirrhosae
100 parts of 90 parts of Radix Salviae Miltiorrhizaes of 10 parts of Bombyx Batryticatus of Borneolum Syntheticum
15 parts of 30 parts of artificial Calculus Boviss of 90 parts of succinums Radix Ophiopogonis
Other is ground into coarse powder except that artificial Calculus Bovis, Borneolum Syntheticum carefully grind with Chinese crude drug, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, drying is ground into fine powder; Above-mentioned whole fine powders are even by described mixed, make.
Embodiment 4: the preparation of capsule
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
90 parts of 90 parts of Radix Polygalaes of 60 parts of Arisaema Cum Bile of Rhizoma Gastrodiae
150 parts of 30 parts of Rhizoma Acori Graminei of 60 parts of Radix Ginsengs of Herba Lophatheri
60 parts in 60 portions of Rhizoma Zingiberis Recenss of 30 portions of Scorpios of Bulbus Fritillariae Cirrhosae
100 parts of 90 parts of Radix Salviae Miltiorrhizaes of 10 parts of Bombyx Batryticatus of Borneolum Syntheticum
15 parts of 30 parts of artificial Calculus Boviss of 90 parts of succinums Radix Ophiopogonis
Chinese crude drug succinum, Scorpio, Radix Ginseng, Bombyx Batryticatus are crushed to 120 purpose fine powders; Secondary will be decocted with water Chinese crude drug Rhizoma Gastrodiae, Arisaema Cum Bile, Radix Polygalae, Herba Lophatheri, Rhizoma Acori Graminei, Bulbus Fritillariae Cirrhosae, Rhizoma Zingiberis Recens, Radix Salviae Miltiorrhizae, Radix Ophiopogonis, each 2 hours, merge and decoct, obtain extracting solution and filtration, the gained extracting solution is condensed into thick paste, add above-mentioned fine powder, mixing drying and crushing to 120 purpose fine powder carefully is being ground into fine powder respectively with Chinese medicine artificial Calculus Bovis, Borneolum Syntheticum; Above-mentioned whole fine powders are even by described mixed, the hard capsule case of packing into.
Embodiment 5: the preparation of capsule
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
90 parts of 90 parts of Radix Polygalaes of 60 parts of Arisaema Cum Bile of Rhizoma Gastrodiae
150 parts of 30 parts of Rhizoma Acori Graminei of 60 parts of Radix Ginsengs of Herba Lophatheri
60 parts in 60 portions of Rhizoma Zingiberis Recenss of 30 portions of Scorpios of Bulbus Fritillariae Cirrhosae
100 parts of 90 parts of Radix Salviae Miltiorrhizaes of 10 parts of Bombyx Batryticatus of Borneolum Syntheticum
15 parts of 30 parts of artificial Calculus Boviss of 90 parts of succinums Radix Ophiopogonis
Other is ground into coarse powder except that artificial Calculus Bovis, Borneolum Syntheticum carefully grind with Chinese crude drug, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, drying is ground into fine powder; Above-mentioned whole fine powders are even by described mixed, the hard capsule case of packing into.
Embodiment 6: the preparation of tablet
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
90 parts of 90 parts of Radix Polygalaes of 60 parts of Arisaema Cum Bile of Rhizoma Gastrodiae
150 parts of 30 parts of Rhizoma Acori Graminei of 60 parts of Radix Ginsengs of Herba Lophatheri
60 parts in 60 portions of Rhizoma Zingiberis Recenss of 30 portions of Scorpios of Bulbus Fritillariae Cirrhosae
100 parts of 90 parts of Radix Salviae Miltiorrhizaes of 10 parts of Bombyx Batryticatus of Borneolum Syntheticum
15 parts of 30 parts of artificial Calculus Boviss of 90 parts of succinums Radix Ophiopogonis
Chinese crude drug succinum, Scorpio, Radix Ginseng, Bombyx Batryticatus are crushed to 120 purpose fine powders; Secondary will be decocted with water Chinese crude drug Rhizoma Gastrodiae, Arisaema Cum Bile, Radix Polygalae, Herba Lophatheri, Rhizoma Acori Graminei, Bulbus Fritillariae Cirrhosae, Rhizoma Zingiberis Recens, Radix Salviae Miltiorrhizae, Radix Ophiopogonis, each 2 hours, merge and decoct, obtain extracting solution and filtration, the gained extracting solution is condensed into thick paste, add above-mentioned fine powder, mixing drying and crushing to 120 purpose fine powder carefully is being ground into fine powder respectively with Chinese medicine artificial Calculus Bovis, Borneolum Syntheticum; Above-mentioned whole fine powders are even by described mixed, add the excipient carboxymethyl cellulose, granulate, and compacting is made in flakes.
Embodiment 7: the preparation of tablet
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
90 parts of 90 parts of Radix Polygalaes of 60 parts of Arisaema Cum Bile of Rhizoma Gastrodiae
150 parts of 30 parts of Rhizoma Acori Graminei of 60 parts of Radix Ginsengs of Herba Lophatheri
60 parts in 60 portions of Rhizoma Zingiberis Recenss of 30 portions of Scorpios of Bulbus Fritillariae Cirrhosae
100 parts of 90 parts of Radix Salviae Miltiorrhizaes of 10 parts of Bombyx Batryticatus of Borneolum Syntheticum
15 parts of 30 parts of artificial Calculus Boviss of 90 parts of succinums Radix Ophiopogonis
Other is ground into coarse powder except that artificial Calculus Bovis, Borneolum Syntheticum carefully grind with Chinese crude drug, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, drying is ground into fine powder; Above-mentioned whole fine powders are even by described mixed, add the excipient cyclodextrin, to granulate, compacting is made in flakes.
Test example 1: the capsule of thing of the present invention (sheet, diffusing) is to the clinical efficacy of treatment epileptics
The material method:
(1) object of study: 356 examples: male 125 examples, women 231 examples, 22 years old mean age, the morbidity history reaches 15 years most, and the shortest is 2 years, and sickness rate is up to 37 times/day, and minimum 5 times/day, the time is the longest 15 minutes, and is the shortest 2 minutes.
Matched group: Yixian pill matched group 5 examples, epilepsy ball 50 examples.
(2) Therapeutic Method:
The treatment group gives 3 of the epilepsy recovering capsules one time of the embodiment of the invention 4, and 3 times on the one, one month is a course of treatment.The matched group Yixian pill is obeyed 1 ball every day, every day secondary, one month is a course of treatment.
Matched group epilepsy ball is obeyed 1 ball every day, every day secondary, one month is a course of treatment.
The matched group Renshen Guipi Wan is obeyed 1 ball every day, every day secondary, one month is a course of treatment.
(3) observational technique:
Each organizes patient's period in a medicine, does blood, urine, just routine test and trace element chemical examination each course of treatment before and after the record, does the heart, liver, kidney function test and EEG (electrocardiogram) examination, does the CT scan inspection in case of necessity.
(4) curative effect index:
The result:
1, thing of the present invention causes epilepsy total effective rate 83.8% to the wind-phlegm impatency, and (P<0.05=is high, sees Table one than matched group Yixian pill 34%.
The sanatory observation of curative effect one of table one thing of the present invention
Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Effective percentage % |
Thing group of the present invention | 118 | 57 | 32 | 10 | 19 | 83.8% |
Matched group | 50 | 2 | 5 | 10 | 33 | 34% |
2, thing of the present invention causes epilepsy total effective rate 88% to disturbing in the phlegm-fire, and (P<0.05=is high, sees Table two than matched group epilepsy ball 38%.
The observation of curative effect two of table two thing treatment of the present invention epilepsy
Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Effective percentage % |
Thing group of the present invention | 134 | 70 | 25 | 23 | 16 | 88% |
Matched group | 50 | 3 | 4 | 12 | 31 | 38% |
3, thing of the present invention causes disease total effective rate 82.6% to deficiency of both the heart and spleen, and (P<0.05=is high, sees Table three than matched group Renshen Guipi Wan 8%.
The observation of curative effect three of table three thing treatment of the present invention epilepsy
Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Effective percentage % |
Thing group of the present invention | 104 | 48 | 25 | 13 | 18 | 82.6% |
Matched group | 50 | 0 | 1 | 3 | 46 | 8% |
By 356 routine patients are observed, its total effective rate is 85.1%, obviously is better than its matched group medicine, and to comprehensive tetanic---clonicity patient effect is better.
One, pharmacodynamic study
1, EMS there is tangible antagonism, reduces the convulsions incidence rate, compare P<0.01 with matched group.
2, MET there is obvious effect, can prolongs and the convulsions time occurs, with matched group P<0.01 relatively.
3, this product has the effect of collaborative calmine sleep inducing, compares P<0.01 with matched group.
But 4, this product significant prolongation anoxia in mice time-to-live etc. also is with matched group P<0.01 relatively.
To sum up, this product is to comprehensive---and tonic clonic seizure, simple partial seizures, complex partial seizures all have remarkable effect.
Two, toxicologic study
With adult 50,100 times of consumption mice is carried out acute toxicity test, the rat long term toxicity test was observed three months, its body weight gain, blood parameters, main organs index, the heart, liver, spleen, lung, nephridial tissue structure inspection no abnormality seen.Clinical patients continuous use a year and a half is not seen untoward reaction.
Three, clinical research
Observe 305 examples by clinical case, capsule of the present invention is controlled epileptics and is had significant curative effect, and cure rate is 64.7%, total effective rate 98%.