CN101732585A - Medicinal composition for treating migraine, preparation method and application thereof - Google Patents
Medicinal composition for treating migraine, preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a medicinal composition for treating migraine, which comprises the following medicaments in part by weight: 4 to 27 parts of Szechuan lovage rhizome, 3 to 26 parts of tall gastrodia tuber, 4 to 28 parts of chrysanthemum, 2 to 24 parts of simpleleaf shrub chastetree fruit, 2 to 24 parts of glossy privet fruit, 2 to 24 parts of twotooth achyranthes root, 2 to 24 parts of Chinese ligusticum rhizome, 3 to 25 parts of white paeony root, 4 to 26 parts of danshen root and 5 to 27 parts of yerbadetajo herb. The invention also provides a preparation method of the medicinal composition, and application of the medicinal composition in calming liver wind, activating blood and dissolving stasis, and treating the migraine of liver wind with phlegm. The medicinal composition not only has the effects of activating blood and dissolving stasis, calming wind and relieving pain, and calming liver wind, but also has the effects of nourishing yin blood of liver and kidney, and clearing heat. The medicinal composition has the main effects of activating blood and dissolving stasis, and calming liver wind.
Description
Technical field
The present invention relates to the migrainous pharmaceutical composition of a kind of treatment, particularly relating to a kind of is the migrainous pharmaceutical composition of treatment that raw material is made with the vegetable Chinese herbal medicine, and the present invention this preparation of drug combination method and purposes.
Background technology
Migraine is a kind of common clinically disease, and doctor trained in Western medicine belongs to angioneurotic headache.The traditional Chinese medical science thinks, head be " confluence of all yang-channels ", " mansion of clear sun ", and is the brain place, the blood of all the five internal organs elite, and six internal organs are the gas of sun clearly, annotates in head on all.So no matter be that prolonged illness is lost and supported, injure Liver and kidney, or congenital defect, hepatic and renal YIN deficiency, liver-wind stirring up internally, excessive rising of liver-YANG, follow through on disturb key clearly, still because of depressed rage impairing the liver, pathogen usually intruding into collateral in protracted disease, stagnation of QI congestion, the impatency channels all can cause migraine.And because this disease is many by all disease development of internal injury, the cause of disease is not removed, and must lead through obstinate, shows effect repeatedly, so this clinical common diseases is brought great misery to the patient.
The blood of the five internal organs elite, the gas of the clear sun of six internal organs is annotated in head on all, if QI and blood fills, the negative and positive lifting is as usual, and the sense nothing but time does not the outward have the symptom of headache, if prolonged illness injures Liver and kidney or congenital defect or the Liver and kidney essence and blood of lacking of proper care after one's birth loses empty, the moon is not made sun, and is moving in the wind sun of liver, on disturb clearly key and then have a headache; Or because of pathogen usually intruding into collateral in protracted disease, or depressed rage impairing the liver, the stagnation of QI is blood stasis then, blood vessels are obstructed, close the YIN pulse network, general rule headache also can attack because of the wind sun and cause clearly in upper orifices that unfavorable of key is headache, and clinical more above often several combined factors effects or several cause of disease of seeing coexists more, thereby form existing Liver and kidney deficiency of YIN-blood, liver-wind stirring up internally is arranged again, and the outer of existing ailment said due to cold or exposure attacked, and the internal resistance of blood stasis is arranged again, therefore the existing headache of seeing altogether of clinical manifestation, that disturbs on the visible again liver-wind has a dizzy spell, both disease tongue pulse conditions of visible blood-stasis internal-depression, and visible again Liver and kidney loses sun and sees not clear, tinnitus, soreness of the waist and knees.But its basic sick position of comprehensive all diseases is at brain, sick this liver, basic pathogenesis mainly is the liver-wind folder stasis of blood, so be main method of treatment with promoting blood circulation and stopping pain, suppressing the hyperactive liver to relieve the wind syndrome in treatment.
Summary of the invention
The purpose of this invention is to provide a kind of promoting blood circulation and stopping pain, suppressing the hyperactive liver to relieve the wind syndrome cures mainly the migrainous pharmaceutical composition that liver-wind presss from both sides blood stasis syndrome.
Another object of the present invention provides the migrainous preparation of drug combination method of a kind of treatment.
A further object of the present invention provides a kind of application for the treatment of migrainous pharmaceutical composition at the migrainous medicine of treatment liver-wind folder blood stasis syndrome.
Technical scheme of the present invention with reference to inventor's experience for many years, filters out the energy promoting blood circulation and stopping pain based on the understanding of motherland's medical science to migraine mechanism, and suppressing the hyperactive liver to relieve the wind syndrome cures mainly the migrainous pharmaceutical composition that liver-wind presss from both sides blood stasis syndrome.
The raw material of pharmaceutical composition of the present invention contains following medicaments in part by weight:
4 to 27 parts of Rhizoma Chuanxiongs, 3 to 26 parts in Rhizoma Gastrodiae, 4 to 28 parts of Flos Chrysanthemis, 2 to 24 parts of Fructus Viticises, 2 to 24 parts of Fructus Ligustri Lucidi, 2 to 24 parts of Radix Achyranthis Bidentataes, 2 to 24 parts of Rhizoma Ligusticis, 3 to 25 parts of the Radix Paeoniae Albas, 4 to 26 parts of Radix Salviae Miltiorrhizaes, 5 to 27 parts of Herba Ecliptaes.
Preferred weight part ratio range is: 3 to 7 parts of Rhizoma Chuanxiongs, 2 to 6 parts in Rhizoma Gastrodiae, 4 to 6 parts of Flos Chrysanthemis, 2 to 5 parts of Fructus Viticises, 2 to 5 parts of Fructus Ligustri Lucidi, 2 to 5 parts of Radix Achyranthis Bidentataes, 2 to 5 parts of Rhizoma Ligusticis, 3 to 5 parts of the Radix Paeoniae Albas, 3 to 7 parts of Radix Salviae Miltiorrhizaes, 5 to 7 parts of Herba Ecliptaes.
Aforementioned pharmaceutical compositions can further contain pharmaceutically acceptable carrier, as beta-schardinger dextrin-, starch, magnesium stearate, carboxymethyl starch sodium, carboxymethyl cellulose sodium, microcrystalline Cellulose, Fructus Citri Limoniae essence etc.
Pharmaceutical composition of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations, and capsule, granule, tablet, pill, solution, suspending agent, Emulsion are arranged.
Preparation of drug combination method of the present invention (one) is: get Rhizoma Gastrodiae and be broken into fine powder; Radix Salviae Miltiorrhizae adds 50% alcohol reflux twice of 7 times of parts by weight again with 85% alcohol reflux of 9 times of parts by weight 1 to 2 hour, and each 1 to 2 hour, merging filtrate, decompression recycling ethanol, dry extract gets Radix Salviae Miltiorrhizae dry extract; Rhizoma Chuanxiong, Fructus Viticis, Rhizoma Ligustici are shredded with the Flos Chrysanthemi distillating extracting oil, and be standby, and the aqueous solution that distills after 3 to 5 hours filters, and it is 1.20 to 1.25 (60 ℃) that filtrate is concentrated into relative density, gets filtrate one; The medicinal residues and the Radix Paeoniae Alba, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae decoct with water three times, add 6 to 8 times of amounts of water respectively, extract 1 to 2 hour at every turn, filter, collecting decoction, being evaporated to relative density is 1.20 to 1.25 (60 ℃), get filtrate two, merge with filtrate one, put coldly, adding ethanol is 65% weight fraction to containing the alcohol amount, fully stir, leave standstill more than 20 hours, get the supernatant concentrating under reduced pressure, dryly must mix dry extract; Get Rhizoma Gastrodiae fine powder, Radix Salviae Miltiorrhizae dry extract, mixing dry extract and appropriate amount of starch, spray into volatile oil, mix homogeneously sealed 3 to 5 hours, and 60 ℃ of dryings are made pharmaceutical composition.
Preparation of drug combination method of the present invention (two) is: get Rhizoma Gastrodiae and be broken into fine powder; Radix Salviae Miltiorrhizae adds 50% alcohol reflux twice of 7 times of parts by weight again with 85% alcohol reflux of 9 times of parts by weight 1 to 2 hour, and each 1 to 2 hour, merging filtrate, decompression recycling ethanol, dry extract gets Radix Salviae Miltiorrhizae dry extract; Rhizoma Chuanxiong, Fructus Viticis, Rhizoma Ligustici are shredded with the Flos Chrysanthemi distillating extracting oil, and the volatile oil beta-cyclodextrin inclusion compound is standby, and the aqueous solution that distills after 3 to 5 hours filters, and relative density was 1.20 to 1.25 when filtrate was concentrated into 60 ℃, got filtrate three; The medicinal residues and the Radix Paeoniae Alba, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae decoct with water three times, add 6 to 8 times of amounts of water respectively, extract 1 to 2 hour at every turn, filter, collecting decoction, relative density is 1.20 to 1.25 when being evaporated to 60 ℃, get filtrate four, filtrate four merges with filtrate three, puts coldly, and adding ethanol is 65% weight fraction to containing the alcohol amount, fully stir, leave standstill more than 20 hours, get the supernatant concentrating under reduced pressure, dryly must mix dry extract; Get Rhizoma Gastrodiae fine powder, Radix Salviae Miltiorrhizae dry extract, mixing dry extract and appropriate amount of starch, add Benexate Hydrochloride, mix homogeneously sealed 3 to 5 hours, and 60 ℃ of dryings are made pharmaceutical composition.
Wherein said Rhizoma Chuanxiong is the dry rhizome of samphire Rhizoma Chuanxiong Ligusticum chuanxiong Hort..Main product in Sichuan, ground such as Jiangxi, Hubei, Shaanxi.
Rhizoma Gastrodiae is the dry tuber of orchid Rhizoma Gastrodiae Gastrodia elata Bl..Main product in Dabie Mountain, Anhui, Shaanxi Qin crust mountain area, Sichuan, Yunnan, Guizhou.
Flos Chrysanthemi is the dry capitulum of feverfew chrysanthemum Chrysanthemum morifolium Ramat..Main product in Hebei, ground such as Henan, Shandong, Anhui.
Fructus Viticis is the dry mature fruit of Verenaceae plant Vitex rotundifolia Vitex trifolia L. var.simplicifolia Cham. or wild pepper Vitex trifolia L..Main product Shandong, Jiangxi, Zhejiang, Fujian and Yunnan.
Fructus Ligustri Lucidi is the dry mature fruit of Oleaceae plant Fructus Ligustri Lucidi Ligustrum lucidum Ait..Distribution East China, south China, southwest and various places, Central China.
Radix Achyranthis Bidentatae is the dry root of amaranthaceous plant Radix Achyranthis Bidentatae Achyranthes bidentata BL..Main product in Sichuan, ground such as Guizhou and Yunnan.
Dry rhizome and the root of Rhizoma Ligustici samphire Rhizoma Ligustici Ligusticum sinense Oliv. or Rhizoma Ligustici Ligusticum jeholenseNakai et Kitag..Ground such as main product Hubei, Hunan, Sichuan, Liaoning, Hebei, Xinjiang.
The Radix Paeoniae Alba is the dry root of ranunculaceae plant Radix Paeoniae Paeonia lactiflora Pall..Ground such as main product Zhejiang, Anhui, Sichuan.
Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge..Main product in Jiangsu, ground such as Anhui, Hebei, Sichuan, Shandong.
Herba Ecliptae is the dry aerial parts of feverfew Eclipta prostrata Eclipta prostrata L., taps when the flowers are in blossom, dries.Main product in Jiangsu, Zhejiang, Jiangxi, Hubei, Guangdong.
Be monarch drug with the Rhizoma Chuanxiong in the prescription of the present invention.Rhizoma Chuanxiong, fragrance is hot to loose, blood-activating and qi-promoting, the pain relieving that relieves dizziness, high fever, infantile convulsions, epilepsy, etc. is the medicine that the six channels headache must be used, the stagnation of QI in the Rhizoma Chuanxiong promoting the circulation of blood, the current twelve regular channels has thin QI and blood, the merit of the pain that relieves the pain.
The ministerial drug Rhizoma Gastrodiae, sweet gentle profit, kind energy suppressing liver-YANG, pain relieving relieves dizziness, high fever, infantile convulsions, epilepsy, etc.Flos Chrysanthemi is hot cool bitter sweet, can rise and can fall, and advocates catharsis and reaches in the top, mountain peak, receives to pick up empty sun and belong to Liver and kidney, can suppressing the hyperactive liver, put out endogenous wind, and press down the perverse and unreasonable manner of wood gas, floating on the empty sun of picking up, to wind heat, liver-fire, liver-yang, the headache due to the deficiency of YIN, blood deficiency dizzyly all can be used." herbal classic " says " main all dizziness due to wind, swell and ache, order desires to take off lacrimation ".Fructus Viticis, toil is relieved inflammation or internal heat and not quick-fried, the head wind heat of loosing, it is heavy to control head, dusk vexed pain, three medicine compatibilities are held concurrently with suppressing the hyperactive liver to relieve the wind syndrome and are evacuated exogenous wind, share with monarch drug and play altogether, treatment headache, dizzy, promoting blood circulation and stopping pain, the effect of suppressing the hyperactive liver to relieve the wind syndrome, this three medicine is ministerial drug altogether.
The adjuvant drug Radix Paeoniae Alba goes into the liver blood branch, the yin nourishing of enriching blood, and the suppressing the hyperactive liver pain relieving, acid can restrain, and bitter cold expels the heat-evil, and can change the moon and enrich blood and seek yin fluid astringing, moist liver spleen, foster passages through which vital energy circulates softens.Rhizoma Ligustici relieves dizziness, high fever, infantile convulsions, epilepsy, etc. pain relieving to control exogenous wind, and " Rhizoma Ligustici, acrid in the mouth, hardship, temperature are said in " book on Chinese herbal medicine covers bamboo fish trap " record.The gas savoury is thin, rises also, and sun also.", grasp hot diffusing property with it, the up head of energy, removing obstruction in the collateral to relieve pain, the particularly key medicine of top, mountain peak headache.Rhizoma Ligustici is " also false tying-in " in this drug regimen, must join cold and cool product such as the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Fructus Ligustri Lucidi, Fructus Viticis, can supervise its hot using warming therapy, belong to the justice of " going property is taken " in compatibility, get it and walk key clearly, yang invigoratingization is turbid, removing obstruction in the collateral to relieve pain thinks that messenger drug reaches the usefulness of disease institute.Fructus Ligustri Lucidi sweetness and bitterness is slightly cold, goes into the cloudy liquid of Liver and kidney, nourish liver and kidney, grows and oiliness the deficiency-heat of liver heat removing kidney, heat clearing away and do not decrease yang-energy, but nourishing YIN suppressing the hyperactive liver and subsiding YANG again.Liver and kidney tonifying is grown in the yin nourishing of Herba Ecliptae removing heat from blood, two to mutual reinforcement between be usefulness, increase the merit of liver and kidney tonifying.Because of adopting day of Fructus Ligustri Lucidi Winter Solstice, the receiving day of Herba Ecliptae Summer Solstice, the elite in collection summer in winter has the wonderful of the negative and positive of complying with, and four medicines must be joined, and educate positive YANG hyperactivity suppressing, moisten the moon of nourishing the liver and kidney, and liver must moisten then wind sun self-gravitation, and water can be contained wooden, does not have the trouble of Yuanyang certainly.Above four Chinese medicine is adjuvant drug altogether.
Messenger drug Radix Salviae Miltiorrhizae promoting blood circulation to disperse blood clots and relieves pain, " book on Chinese herbal medicine converges and says " said: " be apt to control blood system, remove the tissue regeneration promoting that stagnates, regulating menstruation along the feeling pulse medicine also ".The Radix Achyranthis Bidentatae nourishing the liver and kidney, clots absorbing is promoted blood circulation." Bencao Jingshu ": " Radix Achyranthis Bidentatae is walked and can be mended, and so property is kind descending, go into Liver and kidney " and this property of medicine are walked and to exercise liver-yang down not high, and liver-wind is easily flat, with Radix Salviae Miltiorrhizae with the blood circulation promoting and blood stasis dispelling of strengthening the monarch drug Rhizoma Chuanxiong in common, the merit of pain relieving, more than two medicines of distinguishing the flavor of be messenger drug altogether.
The existing blood circulation promoting and blood stasis dispelling of comprehensive all medicines we, the analgesic effect that relieves dizziness, high fever, infantile convulsions, epilepsy, etc. have the merit of suppressing the hyperactive liver to relieve the wind syndrome again, and the cloudy blood of existing nourishing the liver and kidney has the merit of heat clearing away again, and summing up the main effect of above monarch-minister drug and the main effect of effect we of adjuvant is promoting blood circulation and stopping pain, suppressing the hyperactive liver to relieve the wind syndrome.
Pharmaceutical composition of the present invention can be used for suppressing the hyperactive liver to relieve the wind syndrome, and blood circulation promoting and blood stasis dispelling cures mainly the migraine that liver-wind presss from both sides blood stasis syndrome.
The specific embodiment:
The several embodiment of various details, but content of the present invention is not limited to this.
Embodiment one
Get Rhizoma Chuanxiong 6 weight portions, Rhizoma Gastrodiae 4 weight portions, Flos Chrysanthemi 5 weight portions, Fructus Viticis 3 weight portions, Fructus Ligustri Lucidi 3 weight portions, Radix Achyranthis Bidentatae 4 weight portions, Rhizoma Ligustici 4 weight portions, the Radix Paeoniae Alba 4 weight portions, Radix Salviae Miltiorrhizae 5 weight portions, Herba Ecliptae 6 weight portions, all crude drug are 4328g altogether.Rhizoma Gastrodiae powder is broken into fine powder, and Radix Salviae Miltiorrhizae adds 50% alcohol reflux twice again with 85% alcohol reflux 1.5 hours, and each 1 hour, merging filtrate, decompression recycling ethanol, dry dry extract.Rhizoma Chuanxiong, Fructus Viticis, Rhizoma Ligustici are shredded with the Flos Chrysanthemi distillating extracting oil, and the volatile oil beta-cyclodextrin inclusion compound is standby, and the aqueous solution that distills after 4 hours filters, and filtrate is concentrated into relative density and is 1.20 to 1.25 (60 ℃), and is standby; The medicinal residues and the Radix Paeoniae Alba, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae decoct with water three times, add 8,6,6 times of amounts of water respectively, extract 2,1,1 hours, filter, collecting decoction, being evaporated to relative density is 1.20 to 1.25 (60 ℃), merges with decocting liquid such as Rhizoma Chuanxiong, put cold, adding ethanol is 65% to containing the alcohol amount, fully stirs, and leaves standstill 24 hours, get the supernatant concentrating under reduced pressure, the dry dry extract that gets.Get Rhizoma Gastrodiae fine powder, tanshinol promotion cream fine powder, the dried cream fine powder of water extract-alcohol precipitation and appropriate amount of starch, add Benexate Hydrochloride, mix homogeneously behind the granulate seals and carries out the capsule filling after 4 hours, makes 1000.
Embodiment two
Get Rhizoma Chuanxiong 4 weight portions, Rhizoma Gastrodiae 3 weight portions, Flos Chrysanthemi 8 weight portions, Fructus Viticis 3 weight portions, Fructus Ligustri Lucidi 3 weight portions, Radix Achyranthis Bidentatae 3 weight portions, Rhizoma Ligustici 3 weight portions, the Radix Paeoniae Alba 7 weight portions, Radix Salviae Miltiorrhizae 8 weight portions, Herba Ecliptae 10 weight portions, all crude drug are 4328g altogether.Rhizoma Gastrodiae powder is broken into fine powder, and Radix Salviae Miltiorrhizae adds 50% alcohol reflux secondary again with 85% alcohol reflux 1.5 hours, and each 1 hour, merging filtrate, decompression recycling ethanol, dry dry extract.Rhizoma Chuanxiong, Fructus Viticis, Rhizoma Ligustici are shredded with the Flos Chrysanthemi distillating extracting oil, and the volatile oil beta-cyclodextrin inclusion compound is standby, and the aqueous solution that distills after 4 hours filters, and filtrate is concentrated into relative density and is 1.20 to 1.25 (60 ℃), and is standby; The medicinal residues and the Radix Paeoniae Alba, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae decoct with water three times, add 8,6,6 times of amounts of water respectively, extract 2,1,1 hours, filter, collecting decoction, being evaporated to relative density is 1.20 to 1.25 (60 ℃), merges with decocting liquid such as Rhizoma Chuanxiong, put cold, adding ethanol is 65% to containing the alcohol amount, fully stirs, and leaves standstill 24 hours, get the supernatant concentrating under reduced pressure, the dry dry extract that gets.Get Rhizoma Gastrodiae fine powder, tanshinol promotion cream fine powder, the dried cream fine powder of water extract-alcohol precipitation, add Benexate Hydrochloride and appropriate amount of starch, microcrystalline Cellulose, magnesium stearate, carboxymethyl starch sodium mix homogeneously, make granule with ethanol, soft material is granulated with 16 mesh sieves, 60 ℃ of dryings 25 minutes, granulate, always mixed 20 minutes, be pressed into 1000, make tablet.
Embodiment three
Get Rhizoma Chuanxiong 27 weight portions, Rhizoma Gastrodiae 26 weight portions, Flos Chrysanthemi 28 weight portions, Fructus Viticis 24 weight portions, Fructus Ligustri Lucidi 24 weight portions, Radix Achyranthis Bidentatae 24 weight portions, Rhizoma Ligustici 24 weight portions, the Radix Paeoniae Alba 25 weight portions, Radix Salviae Miltiorrhizae 26 weight portions, Herba Ecliptae 27 weight portions, all crude drug are 4328g altogether.Rhizoma Gastrodiae powder is broken into fine powder, and Radix Salviae Miltiorrhizae adds 50% alcohol reflux secondary again with 85% alcohol reflux 1.5 hours, and each 1 hour, merging filtrate, decompression recycling ethanol, dry dry extract.Rhizoma Chuanxiong, Fructus Viticis, Rhizoma Ligustici are shredded with the Flos Chrysanthemi distillating extracting oil, and the volatile oil beta-cyclodextrin inclusion compound is standby, and the aqueous solution that distills after 4 hours filters, and filtrate is concentrated into relative density and is 1.20 to 1.25 (60 ℃), and is standby; The medicinal residues and the Radix Paeoniae Alba, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae decoct with water three times, add 8,6,6 times of amounts of water respectively, extract 2,1,1 hours, filter, collecting decoction, being evaporated to relative density is 1.20 to 1.25 (60 ℃), merges with decocting liquid such as Rhizoma Chuanxiong, put cold, adding ethanol is 65% to containing the alcohol amount, fully stirs, and leaves standstill 24 hours, get the supernatant concentrating under reduced pressure, the dry dry extract that gets.Get Rhizoma Gastrodiae fine powder, tanshinol promotion cream fine powder, the dried cream fine powder of water extract-alcohol precipitation and appropriate amount of starch, add Benexate Hydrochloride, make granule with ethanol, soft material is granulated with 16 mesh sieves, and 60 ℃ of dryings 25 minutes, were always mixed 20 minutes granulate, the aluminum-plastic composite membrane bag of packing into, is made granule by 200 bags.
Embodiment four
Get Rhizoma Chuanxiong 8 weight portions, Rhizoma Gastrodiae 6 weight portions, Flos Chrysanthemi 7 weight portions, Fructus Viticis 5 weight portions, Fructus Ligustri Lucidi 5 weight portions, Radix Achyranthis Bidentatae 5 weight portions, Rhizoma Ligustici 5 weight portions, the Radix Paeoniae Alba 7 weight portions, Radix Salviae Miltiorrhizae 9 weight portions, Herba Ecliptae 11 weight portions, all crude drug are 4328g altogether.Rhizoma Gastrodiae powder is broken into fine powder, and Radix Salviae Miltiorrhizae adds 50% alcohol reflux secondary again with 85% alcohol reflux 1.5 hours, and each 1 hour, merging filtrate, decompression recycling ethanol, dry dry extract.Rhizoma Chuanxiong, Fructus Viticis, Rhizoma Ligustici are shredded with the Flos Chrysanthemi distillating extracting oil, and the volatile oil beta-cyclodextrin inclusion compound is standby, and the aqueous solution that distills after 4 hours filters, and filtrate is concentrated into relative density and is 1.20 to 1.25 (60 ℃), and is standby; The medicinal residues and the Radix Paeoniae Alba, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae decoct with water three times, add 8,6,6 times of amounts of water respectively, extract 2,1,1 hours, filter, collecting decoction, being evaporated to relative density is 1.20 to 1.25 (60 ℃), merges with decocting liquid such as Rhizoma Chuanxiong, put cold, adding ethanol is 65% to containing the alcohol amount, fully stirs, and leaves standstill 24 hours, get the supernatant concentrating under reduced pressure, the dry dry extract that gets.Get Rhizoma Gastrodiae fine powder, tanshinol promotion cream fine powder, the dried cream fine powder of water extract-alcohol precipitation, add the Benexate Hydrochloride mix homogeneously, grind well, add the Fructus Citri Limoniae essence mixing and make suspension, promptly get oral liquid with an amount of carboxymethyl cellulose sodium rubber cement.
Essence for a better understanding of the present invention will illustrate that it is in the excellent effect aspect the treatment migraine with the Experiment of Zoology of the pharmacological effect toxicity of pharmaceutical composition of the present invention and clinical pharmacology experiment and result below.
Get 1000 pharmaceutical compositions that embodiment one makes, it is 5.4g that the every gram of medicated powder contains the crude drug amount, is mixed with 0.2g/ml with distilled water during experiment.The administration capacity is 10ml/kg, and the positive control drug ZHENNAONING JIAONANG is Tonghua, Jilin Bai Shan pharmacy five factory's products, and lot number 930916 (it is identical that ZHENNAONING JIAONANG and this pharmaceutical composition cure mainly, functional similarity, dosage form is identical with route of administration).
Animal: Kunming mouse, body weight are 18 to 22g, the male and female dual-purpose, and source Jilin Prov. Inst. of Chinese Medicine and Chinese Medical Science animal housing, the certification of fitness number is 93000005.
Instrument: GJ-8402 type hot plate dolorimeter, the zxc-4 type is from the movable analyzer in side, and RM-6000 four leads the physiological measurement instrument, CM-1200 type electromagnetic flowmeter, WX-7533 type multi-section position microscope, L-100 type hemorheology is learned detector.
Experimental data is all handled through the t check, and the result represents with X ± SD.
Method and result:
One, analgesic activity experiment
1, to the influence (hot plate method) of mice burning pain threshold value
Get female mice, on 55 ± 1 ℃ of hot plates, screen, choose pain threshold 50 of mices in 10 to 30 seconds, be divided into 5 groups at random, wherein irritate stomach respectively and give pharmaceutical composition 2.0,1.0 of the present invention and 0.5g/kg and ZHENNAONING JIAONANG 1.0g/kg for 4 groups, matched group is given equal-volume water, every day 1 time, continuous 3 days.Write down before the administration respectively and the last administration after pain threshold per hour in 5 hours.The results are shown in Table 1.
Table 1 result shows that pharmaceutical composition of the present invention and ZHENNAONING JIAONANG all can improve the mice pain threshold, and especially effect is more obvious in the time of 3 and 4 hours, and is remarkable with the matched group comparing difference.
2, the influence (method of acetic acid) that mouse writhing is reacted
Get 50 of mices, be divided into 5 groups at random, press the gastric infusion of dosage shown in the table 2, every day 1 time, continuous 3 days.After the last administration 1 hour, lumbar injection 1% acetic acid 10ml/kg observed 10 minutes mouse writhing reaction times, the results are shown in Table 2.
The influence that table 2 pharmaceutical composition of the present invention reacts mouse writhing (X ± SD)
| Group (g/kg) | Number of animals (only) | The writhing response number of times | The P value |
| Contrast | ??10 | ??32.3±8.98 | |
| ZHENNAONING JIAONANG 1.0 | ??10 | ??21.30±7.63 | ??＜0.05 |
| Pharmaceutical composition 2.0 of the present invention | ??10 | ??19.00±9.26 | ??＜0.01 |
| Pharmaceutical composition 1.0 of the present invention | ??10 | ??21.00±9.26 | ??＜0.01 |
| Pharmaceutical composition 0.5 of the present invention | ??10 | ??21.00±8.51 | ??＜0.01 |
Table 2 is the result show, pharmaceutical composition of the present invention can reduce the mouse writhing reaction times that acetic acid causes, and is remarkable with the matched group comparing difference, has obvious analgesic activity in conjunction with above-mentioned two pain threshold measurement results explanation this product.
Two, to the influence of mice sedation
1, to the influence of mice autonomic activities number of times
Get 50 of mices, be divided into 5 groups at random, press the gastric infusion of dosage shown in the table 3, every day 1 time, continuous 7 days.After the last administration 1 hour, mice is inserted ZXC-4 type autonomic activities analyzer, adapt to 3 minutes, survey mice autonomic activities number of times in 5 minutes.The results are shown in Table 3.
Table 3 pharmaceutical composition of the present invention is to the influence of mice autonomic activities (X ± SD)
| Group (g/kg) | Number of animals (only) | The autonomic activities number of times | The P value |
| Contrast | ??10 | ??92.70±13.45 | |
| ZHENNAONING JIAONANG 1.0 | ??10 | ??35.22±21.28 | ??＜0.001 |
| Pharmaceutical composition 2.0 of the present invention | ??10 | ??50.80±18.14 | ??＜0.001 |
| Pharmaceutical composition 1.0 of the present invention | ??10 | ??59.00±36.57 | ??＜0.001 |
| Pharmaceutical composition 0.5 of the present invention | ??10 | ??56.30±23.98 | ??＜0.001 |
The result shows that pharmaceutical composition of the present invention can obviously reduce mice autonomic activities number of times.
2, to the influence of the length of one's sleep of sub-threshold dose pentobarbital sodium
Get 49 of mices, be divided into 5 groups at random, press the gastric infusion of dosage shown in the table 5, every day 1 time, continuous 7 days.After the last administration 1 hour, lumbar injection pentobarbital sodium 30mg/kg observed 15 minutes mice sleep numbers, and its result is through X
2Check the results are shown in Table 4.
Table 4 pharmaceutical composition of the present invention is to the influence of mice sub-threshold dose pentobarbital sodium sleep
| Group (g/kg) | Number of animals (only) | Sleeping number of elements | The end number of elements of sleeping | ??％ | The P value |
| Contrast | ??10 | ??1 | ??9 | ??10.0 | |
| ZHENNAONING JIAONANG 1.0 | ??10 | ??7 | ??3 | ??70.0 | ??＜0.05 |
| Pharmaceutical composition 2.0 of the present invention | ??10 | ??7 | ??3 | ??70.0 | ??＜0.05 |
| Pharmaceutical composition 1.0 of the present invention | ??9 | ??4 | ??5 | ??44.4 | ??＞0.05 |
| Pharmaceutical composition 0.5 of the present invention | ??10 | ??3 | ??7 | ??30.1 | ??＞0.05 |
The result shows that pharmaceutical composition of the present invention can obviously increase the sleep number that gives sub-threshold dose pentobarbital sodium mice.In conjunction with its influence, illustrate that this product has tangible sedation to the mice autonomic activities.
Three, to the influence of cat cerebral blood flow, blood pressure and heart rate
25 of cats, be divided into 5 groups at random, give 3% pentobarbital sodium 1ml/kg intraperitoneal injection of anesthesia respectively, ligation left side external carotid artery is put the left carotid place with the electromagnetic flowmeter probe, presses the administration respectively of dosage shown in the table 6, through the PM-6000 physiograph, 5,30,45,60,90,120 and 150 timesharing common carotid artery blood flow, blood pressure and heart rate after the record administration, and calculate cerebral blood flow (ml/100gmin), mean blood pressure (kpa) and cerebral vascular resistance the results are shown in Table 5 and table 6.
Table 5 is the result show, pharmaceutical composition of the present invention can obviously increase the cat cerebral blood flow and bring high blood pressure down, and more obvious when it acts on 60,120 minutes, pharmaceutical composition of the present invention does not have obvious influence to the cat heart rate.Cerebral vascular resistance had obvious reduction when table 6 result showed after administration 45120 minutes.
Four, to the microvascular influence of mouse ear
Get 32 of mices, be divided into 4 groups at random, press the gastric infusion of dosage shown in the table 8, every day 1 time, continuous 7 days.After the last administration 30 minutes, lumbar injection pentobarbital sodium 50mg/kg, after the Animal Anesthesia Mice Auricle placed following 80 times of WX-7533 type multilocation microcirculation microscope, measure ear artery and vein vascular diameter, getting artery diameter is that 5 μ m and vein diameter are the blood vessel observation of 10 μ m, intravenous injection epinephrine 100 μ g/kg, 2,5, the 10 and 20 minutes blood vessel diameters in record injection back the results are shown in Table 7.
Experimental result shows that vasoconstriction has antagonism to pharmaceutical composition of the present invention to Mice Auricle, illustrates that this product has the microcirculation improvement effect.
Five, to the influence of rat blood viscosity
Get 40 of rats, be divided into 5 groups at random, press the gastric infusion of dosage shown in the table 9, matched group is given equal-volume water, every day 1 time, continuous 15 days.Fasting is 16 hours before the experiment, and 1 hour blood sampling 4ml (heparin sodium anticoagulant) detects plasma viscosity and whole blood viscosity after the last administration, the results are shown in Table 8.
Table 8 result shows that pharmaceutical composition of the present invention can make the rat whole blood viscosity reduce, and is remarkable with the matched group comparing difference.
Conclusion
By hot plate method, method of acetic acid and mechanical tenderness method experimental results show that pharmaceutical composition of the present invention has obvious analgesic activity.Do the observation of hypnosis time of sub-threshold dose pentobarbital sodium is illustrated that pharmaceutical composition of the present invention has obvious sedation that this effect is beneficial to the performance of its analgesic activity by the experiment of mice autonomic activities.
By the observation of cat cerebral blood flow, illustrate pharmaceutical composition of the present invention obviously the cerebral blood flow increasing amount, bring high blood pressure down, but heart rate is not had obvious influence.Learn detection by microcirculation and hemorheology, but pharmaceutical composition microcirculation improvement of the present invention is described and reduces whole blood viscosity.Above-mentioned experimental result may be a medicine composite for curing headache mechanism of the present invention.
In a word, pharmaceutical composition of the present invention has obvious analgesia, sedation, but cerebral blood flow increasing amount in addition bring high blood pressure down and whole blood viscosity, microcirculation improvement, these pharmacological actions provide theoretical foundation for this product clinical treatment liver-yang and headache due to blood stasis.
Clinical experiment
Researcher:
Clinical trial unit: Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ, Provincial Medicine Research Institute, Jilin, Attached Hospital, Changchun Chinese Medicinal College, the attached institute of traditional Chinese medicine of Luzhou Medical College
Dosage regimen:
The treatment group: medicament composition capsule of the present invention, oral, each 5 (0.4g/ grain), every day 3 times
Matched group: ZHENNAONING JIAONANG (product batch number: 19971201), authentication code: defend the accurate word Z-19 of medicine number, and Bai Shan pharmacy five factories in Tonghua, Jilin produce, and are oral, each 5 (0.3g/ grain), every day 3 times by (92)
The course of treatment: six weeks
Test specimen is provided by Si Chuan Zi Tong medicine pharmaceutical Co. Ltd, and lot number is: 971005.
Case is selected
One, diagnostic criteria
(1) traditional Chinese medical science head wind disease diagnostic criteria: (formulating) by " wind syndrome of head diagnosis and efficacy assessment standard " that the whole nation encephalopathy emergency case cooperative groups discussion of national Department of Health is formulated
1. main symptom: the repeated relapsing headache, the course of disease is more than 6 months or have 5 outbreaks at least.
(1) painful area is how left or right at head one side volume temporo, forehead, top, mountain peak, tosses about in bed to show effect or be full headache.
(2) character of pain mostly is jumping pain, twinge, distending pain, dusk pain, dull pain or headache as splits etc.
(3) the each outbreak of headache continues several minutes, a few hours, and a couple of days, lasting several weeks of person is also arranged, but spontaneous remission.
2. characteristics of incidence: acute or subacute onset, start-stop impermanence.
3. predisposing factors: premonitory symptom is often arranged before not sending out.
4. check: through neurologic check and biochemistry, CT, MRI check and can get rid of organic disease causer in cranial injury and the brain.
Have main symptom (1) (2) (3) and 2,3,4 and can determine diagnosis.
(2) differential diagnosis in tcm standard
The diagnostic criteria of wind blood stasis syndrome syndrome:
The wind blood stasis syndrome: headache with the passing of time, outbreak repeatedly, aching as needle stabbing lancinates, or jumping pain, distending pain, sore spot is fixing not to be moved, dizzy, susceptible to lose temper due to restlessness, insomnia and dreamful sleep, dry mouth with bitter taste, or increase the weight of on the occasion of the menstrual phase headache, menoxenia or clot is arranged is with stomachache; Purplish tongue or band ecchymosis, petechia Sublingual venation is livid purple, deep and hesitant pulse or string.
(3) doctor trained in Western medicine vascular headache (migraine) diagnostic criteria: (draft by history Yuquan work " practical neurological " record " international headache classification ".
1. repeated relapsing vascular headache, the situation and the similar process of each outbreak show effect more than 5 times/month at least, and outbreak is intermittently normal.
Outbreak can with or without premonitory symptom, the locality cortex of shown as completely reversibility of tendency and/or the handicapped premonitory symptom of brain stem such as dizzy, tinnitus are arranged, look ataxia etc. more.
3. outbreak must be had a headache and be had binomial in the following each point at least
(1) is positioned at a side;
(2) pulsation;
(3) to the order of severity, seriously have a headache in: must lie in bed during pain; Moderate headache: influence work during headache; Slight headache: do not influence work during pain.
(4) going upstairs or similar daily physical exertion increase the weight of to some extent.
4. simultaneous phenomenon: feel sick during headache, vomiting, photophobia, phonophobias etc. are with more than one or one.
5. persistence headache outbreak
Two, include the case standard in
(1) meets wind syndrome of head tcm diagnosis and the dialectical standard person of wind blood stasis syndrome;
(2) meet migraine (vascular headache) diagnostic criteria and belong to the patient of stage of attack.
The patient who meets above-mentioned two standards can include the test case in.
Three, get rid of the case standard
(1) non-cephalagra type vascular headache such as hypertension, cerebrovascular, the vascular headache that general disease faintness, anoxia, poisoning etc. cause, temporal arteritis headache, intracranial position pathological changes, the patient behind the head trauma.
(2) merge serious primary disease such as liver, kidney, cardiovascular and hemopoietic system, psychotic.
(3) age is less than 18 years old, greater than 65 years old person.Gestation or women breast-feeding their children, allergic constitution reaches this medicine allergy sufferers.
Four, reject the case standard: all standards of including in that do not meet, not medication in accordance with regulations can't judge that curative effect or data are not congruent, affects the treatment or safety judgement person.
The clinical verification method
One, the contrast therapeutic test stage is adopted randomized controlled trial, each 30 example of treatment group and matched group case, 1: 1 random packet.
(1) oral pharmaceutical composition of the present invention is organized in treatment, and each 5, every day 3 times.
(2) the oral ZHENNAONING JIAONANG of matched group patient, each 4, every day 3 times.
(3) treatment group and matched group were for two weeks the course of treatment, but headache number of times, headache intensity, the observation of headache persistent period are needed to follow up a case by regular visits to first quarter moon at treatment 2 Zhou Houzai.
Two, enlarge contrast therapeutic test stage employing randomized controlled trial, case is distributed by table of random number, carries out in three tame hospitals respectively, and every family hospitalize group case is 90 examples, and the matched group case is 30 examples, 3: 1 random packet.
(1) oral pharmaceutical composition of the present invention is organized in treatment, and each 5, every day 3 times.
(2) the oral Yiganning capsule of forcing into submission of matched group patient, each 4, every day 3 times.
(3) treatment group and the matched group course of treatment in all main 2 weeks, but need after treatment finishes, follow up a case by regular visits to for 2 weeks again to headache number of times, headache intensity, the observation of headache persistent period, amounting to one month, i.e. observation finished after all the other symptom treatments finished.
(4) two groups of patients must not use other medicine relevant with primary disease except that above treatment.
Three, observation index and observed and recorded method
(1), observation index
1. safety observation, each is done once before and after the treatment.
(1) general health check-up project
(2) blood, urine, just routine test.
(3) heart, liver, renal function detect: ECG, ECG, BUN, Cr, ALT (only making the treatment group, at least 1/3 case).
2. health giving quality observation:
(1) persistent period of head pain, attack times, degree, position and character respectively write down 1 time before and after the treatment.
(2) simultaneous phenomenon: insomnia and dreamful sleep, menoxenia etc., respectively write down 1 time before and after the treatment.
(3) variation of tongue arteries and veins, the treatment before, the treatment after respectively write down 1 time.
(4) hemorheology is measured, and respectively writes down 1 time before and after the treatment.
(2) observation, recording method
1. adopt clinic case and inpatient to combine, inpatient is no less than 1/3, and clinic case should be controlled variable factor.
2. fill in the observation table weekly once after the treatment beginning, headache is by headache scoring method record, other symptom and sign of the traditional Chinese medical science with in the hierarchical table of committing suicide (+, ++, +++) fill in after representing, remember 1,2,3 fen respectively.
3. Zhen Duan establishment and treatment back efficacy evaluation should be made the above academic title of the observation table person of filling in tool resident at least jointly by an attending doctor and a resident.
Measurement data is checked with T, and efficacy determination is analyzed with Ridit, enumeration data X
2Check is to relatively concluding before and after the treatment and between group.
(4) untoward reaction is observed
As find untoward reaction, and answer the symptom of itemized record untoward reaction, whether the character of symptom, degree and development thereof, and definite untoward reaction drug-induced whether need to handle, and whether need drug withdrawal etc.
Therapeutic outcome
One, curative effect determinate standard: (formulate by the whole nation encephalopathy emergency case cooperative groups discussion of national Chinese Medicine Pharmacy: " wind syndrome of head diagnosis and efficacy assessment standard " formulated)
(1), headache scoring method:
Mainly be conceived to pain degree, the persistent period, the alleviation situation of outbreak frequency:
1, headache strength grading
Slightly (+): slightly can stand, not influence life and work, count 2 fens
Moderate (++): heavylier still can stand, the work life is affected, and counts 4 fens
Severe (+++): severe pain or bore spine, big with the life and work influence, counted 6 fens
2, headache outbreak persistent period scoring method
Several minutes to 2 hours (containing 2 hours), meter was 1 minute
2 hours to 6 hours (containing 6 hours), meter was 2 minutes
6 hours to 24 hours (containing 24 hours), meter was 3 minutes
24 hours to 72 hours (containing 72 hours), meter was 4 minutes
Counted 5 fens greater than 72 hours persons
If headache disappears, the intensity of no matter having a headache or headache persistent period are all remembered 0 fen,
3, headache number of times: the number of times record with outbreak around every is observed in the table.
4, headache index:
The intensitometer branch that equals each headache outbreak multiply by the long-pending addition of each headache persistent period score.
Index=1 * (F promptly has a headache
1* D
1)+2 * (F
2* D
2)+3 * (F
3* D
3)
Wherein 1,2,3 all light, in, the accent pain.
F represents 4 all times of headache.
D
1, D
2, D
3The average duration of seizure of severe during representative is light.
(2) wind syndrome of head (vascular headache (migraine)) total effects standard
1, prison bed control: curative effect percent is＞90%, and simultaneous phenomenon significantly alleviates.
2, produce effects: curative effect percent is that 55%～90% (not containing 90%) simultaneous phenomenon significantly alleviates.
3, effective: curative effect percent is that 20%～55% (not containing 55%) simultaneous phenomenon alleviates.
4, invalid: curative effect percent＜20%, simultaneous phenomenon does not have change.
(4) tcm syndrome efficacy assessment standard
1, other symptom efficacy evaluation of the traditional Chinese medical science adopts the classification scoring method
(1) dizzy
Slightly (+): idol has generation, can tolerate.Counted 1 fen
Moderate (++): happen occasionally, need medication treatment.Counted 2 fens
Severe (+++): often take place, need medication treatment to alleviate.Counted 3 fens
(2) susceptible to lose temper due to restlessness
Slightly (+): tired anger takes place once in a while, and emotion is stable inadequately.Counted 1 fen
Moderate (++): often tired angry, still can the oneself control.Counted 2 fens
Severe (+++): tired anger is difficult to oneself's control.Counted 3 fens
(3) insomnia and dreamful sleep
Slightly (+): sleep night and easily wake up, have dream.Counted 1 fen
Moderate (++): the dreaminess of sleeping night, do not have enough sleep 4 hours, but can adhere to work.Counted 2 fens
Severe (+++): lie awake all night or make nightmare all night, be difficult to adhere to work.Counted 3 fens
(4) xerostomia, bitter taste
Slightly (+): idol has the xerostomia hardship.Counted 1 fen
Moderate (++): frequent xerostomia hardship.Counted 2 fens
Severe (+++): feel the xerostomia hardship all day.Counted 3 fens
(5) menoxenia or clot is arranged
Slightly (+): the mild pain warp, the menses darkish complexion, idol has clot.Counted 1 fen
Moderate (++): dysmenorrhea, menses darkish complexion, the more or disorder of menstrual cycle of clot.Counted 2 fens
Severe (+++): amenorrhea.Counted 3 fens
(6) abdominal pain in menstruation
Slightly (+): idol has slight stomachache.Counted 1 fen
Moderate (++): moderate stomachache happens occasionally.Counted 2 fens
Severe (+++): unbearably painful, outbreak is toss about and feel uneasy repeatedly.Counted 3 fens
(7) picture of the tongue
Body of the tongue: normal.Counted 0 fen
Body of the tongue is unusual: dim red, or purple dim, or the Sublingual venation is livid purple, or tongue has petechia, or hold ecchymosis under the arm.Counted 1 fen
(8) pulse condition: normal.Counted 0 fen
Heavy or string meter 1 minute
2, tcm syndrome criterion of therapeutical effect:
(1) clinical recovery: treatment back clinical symptoms all disappears.
(2) produce effects: treatment back total mark value descends more than 2/3
(3) effective: treatment back total mark value descends 1/3～2/3
(4) invalid: treatment back total mark value decline less than 1/3
Two, total effects
(1) the two groups of patient's total effectses in treatment back are relatively shown in table 9-1:
Two groups of patient's total effectses of table 9-1 relatively
Two groups of patient's total effectses are analyzed through RIDIT, and R controls=39, and R is right=and 0.515, U=0.69, P＞0.05, difference does not have significance, illustrates that two groups of total effectses are similar.
Three, tcm syndrome, symptom curative effect
(1) the two groups of patient's tcm syndrome curative effects in treatment back are relatively shown in table 10-1
Two groups of patient's traditional Chinese medical science of table 10-1 curative effect relatively
Two groups of patient's tcm syndrome curative effects are analyzed through RIDIT, and R controls=0.4918, and R is right=and 0.5201, U=0.92, P＞0.05, difference does not have significance, illustrates that two groups of patients are similar to the curative effect of tcm syndrome.
(2) the two groups of patient's tcm symptom curative effects in treatment back are relatively shown in table 10-2:
Two groups of patient's tcm symptoms of table 10-2 curative effect relatively
Two groups of each individual event tcm symptoms of patient in treatment back and tongue pulse condition curative effect compare, through X
2Check, P value is equal＞and 0.05, difference does not have significance.
Tcm symptom integration and average reduction value are relatively shown in table 10-3 behind (three) two groups of patient treatments:
Tcm symptom integration and average reduction value are relatively behind two groups of patient treatments of table 10-3
The two groups of patient's symptom integral in treatment back and average than symptom integral before self treatment and average obvious reduction is arranged, the reduction value own control of treatment group tcm symptom integration and average relatively, t=31.11, there is the utmost point significance P＜0.01, difference, illustrate that the treatment group is unusual to dizzy, susceptible to lose temper due to restlessness, insomnia and dreamful sleep, xerostomia tongue hardship and picture of the tongue, abnormal pulse condition improve determined curative effect, two groups of tcm symptom integrations and average reduction value relatively, t=1.15, P＞0.05, difference does not have significance.
(4) the two groups of patients in treatment back have a headache the character curative effect relatively shown in table 10-4:
Two groups of patients of table 10-4 have a headache the character curative effect relatively
Treatment back two groups of patient's heads twinge (or fix and do not move) and head distending pain (or jumping pain) all improve, and two groups of curative effects compare, through X
2Check, matched group is better than the treatment group to the curative effect of head twinge (or fixing do not move), but to the head distending pain (or) curative effect of jumping pain, two groups of curative effects relatively, P＞0.05, difference does not have significance.
(5) comparison of the two groups of patient's irregular menstruation in treatment back:
The patient was 2 weeks at course of treatment of taking medicine, and followed up a case by regular visits to for 2 weeks after the treatment, and in totally 4 weeks, observing time is shorter, was not enough to women's irregular menstruation is made conclusion more accurately, so irregular menstruation is made the health giving quality statistics.
Four. headache onset time analgesic time is analyzed
(1) the two groups of patients in treatment back have a headache onset time relatively shown in table 11-1:
Table 11-1 headache onset time comparison (X ± S)
The two groups of patients in treatment back have a headache onset time relatively, through the t check, and P＞0.05, difference does not have significance, illustrates that the onset time of two groups of treatment headaches is close.
(2) the two groups of patients in treatment back have a headache analgesic time relatively shown in table 11-2:
The comparison of table 11-2 headache analgesic time (X ± S)
The two groups of patients in treatment back analgesic time table of having a headache is relatively backward, through the t check, and P＞0.05, difference does not have significance, illustrates that the analgesic times of two groups of treatment headaches are close.
Five. the headache number of times (inferior/month) relatively
The two groups of patients in treatment back number of times of having a headache is more as shown in table 12:
Table 12 a liang group patient has a headache number of times (inferior/moon) relatively
Two groups of patient's traffic law pain number of times are organized in treatment all has obvious minimizing than the preceding headache of self treatment number of times, the minimizing value own control of treatment group headache number of times relatively, t=13.99, P＜0.01, difference has utmost point significance, illustrates that the treatment group can reduce the attack times of headache, and two groups of headache number of times minimizing values relatively, t=1.01 P＞0.05, difference does not have significance.
Six. score of headache intensity and the score of headache persistent period are relatively
(1) two group of patient has a headache the intensitometer branch relatively shown in table 13-1:
Table 13-1 two groups of patients intensitometer of having a headache divides relatively (X ± S)
The two groups of patients in treatment back have a headache all has obvious reduction before the intensity score is treated than self, treatment group patient have a headache intensity score reduction value own control relatively,, t=21.43, P＜0.01, difference has utmost point significance, illustrate that the treatment group can reduce the score value of headache intensity, two groups of headache intensity score reduction values compare t=1.20, P＞0.05, difference does not have significance.
(2) two groups of patients have a headache the persistent period score relatively shown in table 13-2:
Table 13-2 two groups of patients relatively (X ± S) of persistent period score that has a headache
The two groups of patients in treatment back have a headache all has obvious reduction before the persistent period score is treated than self, treatment group patient have a headache persistent period score reduction value own control relatively, t=22.39, there is the utmost point significance P＜0.01, difference, illustrate that the treatment group has definite curative effect to reducing the headache persistent period, score reduction value relatively between two groups of headaches continued, t=0.72, P＞0.05, difference does not have significance.
In this clinical experiment process, there are 170 routine patients before and after treatment, to carry out blood, urine, just conventional sense among the 302 routine treatment group patients, 136 routine patients have carried out liver function, renal function detects, 141 routine patients have carried out Electrocardioscopy, do not find the untoward reaction of drug-induced, in the drug administration process, have 1 routine patient slight erythra to occur, continue to disappear after the medication not influence treatment.
One, passes through 425 routine wind syndrome of head [vascular headache (migraine)] patient's clinical experiment, the result shows: the obvious effective rate of this medicine composite for curing wind syndrome of head and effective percentage are respectively 66.57%, 84.44%, the obvious effective rate of matched group and effective percentage are respectively 61.79%, 82.93%, two groups of total treatments are similar, analyze P＞0.05 through RIDIT; The treatment group is respectively 69.54%, 86.42% to the obvious effective rate and the effective percentage of tcm syndrome, and it is similar that matched group is respectively 65.04%, 82.11%, two group of tcm syndrome curative effect, analyzes P＞0.05 through RIDIT.
Two, clinical experiment also shows, this pharmaceutical composition can reduce wind syndrome of head [vascular headache (migraine)] patient's headache intensity and the headache persistent period, improve patient's clinical symptoms such as head twinge, distending pain, jumping pain, dizzy, dry mouth with bitter taste, insomnia and dreamful sleep, susceptible to lose temper due to restlessness and the picture of the tongue of performance unusually all had better curative effect.
Three, this pharmaceutical composition has some improvement to wind syndrome of head [vascular headache (migraine)] the higher hemorheology index of patient, to the height that wherein raises cut whole blood viscosity, the low whole blood viscosity, plasma viscosity, erythrocyte rigidity index, erythrocyte aggregation index of cutting all has the reduction effect.
Four, " vascular headache (migraine) " belongs to motherland's medical science " wind syndrome of head " category, is mainly in after the middle age, and deficiency in origin and excess in superficiality is a basic pathogenesis, and deficiency in origin is the deficiency of vital energy, the deficiency of YIN or yang deficiency, and mark is real to be seen on liver-wind or the liver-yang more and disturbs, it is main stopping in the double blood stasis.Liver-wind, liver-yang belong to wood, pathogen upward attacking orifices in head, and QI and blood is disorderly contrary, the retardance of muscle arteries and veins, stagnation of QI and blood may bring about pain, the property of wind wood is apt to change, so the headache oncoming force is very fast, and the clinical manifestation of head wind disease wind blood stasis syndrome is arranged.
Modern medicine study also shows, blood stasis has important function in the development process of wind syndrome of head, show that the every index of blood samples of patients rheology all has rising in various degree, blood is " dense, sticking, poly-, coagulate " state in various degree, so blood circulation promoting and blood stasis dispelling becomes one of important method of treatment of wind syndrome of head.
This pharmaceutical composition is at migrainous etiology and pathogenesis, suppressing the hyperactive liver to relieve the wind syndrome, activating blood circulation to dissipate blood stasis and dredge the collateral, and form through modern crafts are refining, so to the headache twinge due to the wind syndrome of head wind blood stasis syndrome fixingly do not move, dizzy, susceptible to lose temper due to restlessness, insomnia and dreamful sleep, dry mouth with bitter taste, and the body of the tongue stasis of blood is dim, deep and hesitant pulse etc. has obvious curative effects, and can improve patient's's " dense, sticking, poly-, coagulate " hemorheological property, so be used for wind syndrome of head wind blood stasis syndrome, determined curative effect.
Five, this preparation is not found untoward reaction in clinical experiment, takes safety.
Claims (7)
1. the migrainous pharmaceutical composition of treatment is characterized in that the raw material of described pharmaceutical composition contains following medicaments in part by weight: 4 to 27 parts of Rhizoma Chuanxiongs, 3 to 26 parts in Rhizoma Gastrodiae, 4 to 28 parts of Flos Chrysanthemis, 2 to 24 parts of Fructus Viticises, 2 to 24 parts of Fructus Ligustri Lucidi, 2 to 24 parts of Radix Achyranthis Bidentataes, 2 to 24 parts of Rhizoma Ligusticis, 3 to 25 parts of the Radix Paeoniae Albas, 4 to 26 parts of Radix Salviae Miltiorrhizaes, 5 to 27 parts of Herba Ecliptaes.
2. the migrainous pharmaceutical composition of treatment according to claim 1 is characterized in that the raw material of described pharmaceutical composition contains following medicaments in part by weight: 3 to 7 parts of Rhizoma Chuanxiongs, 2 to 6 parts in Rhizoma Gastrodiae, 4 to 6 parts of Flos Chrysanthemis, 2 to 5 parts of Fructus Viticises, 2 to 5 parts of Fructus Ligustri Lucidi, 2 to 5 parts of Radix Achyranthis Bidentataes, 2 to 5 parts of Rhizoma Ligusticis, 3 to 5 parts of the Radix Paeoniae Albas, 3 to 7 parts of Radix Salviae Miltiorrhizaes, 5 to 7 parts of Herba Ecliptaes.
3. according to the migrainous pharmaceutical composition of the described treatment of the arbitrary claim of claim 1 to 2, it is characterized in that described pharmaceutical composition also contains pharmaceutically acceptable carrier.
4. according to the migrainous pharmaceutical composition of the described treatment of the arbitrary claim of claim 1 to 2, it is characterized in that described pharmaceutical composition is any one in capsule, granule, tablet, pill, solution, suspending agent, the Emulsion.
5. the migrainous preparation of drug combination method of the described treatment of the arbitrary claim of claim 1 to 2 is characterized in that: get Rhizoma Gastrodiae powder and be broken into fine powder; Radix Salviae Miltiorrhizae adds 50% alcohol reflux twice of 7 times of parts by weight again with 85% alcohol reflux of 9 times of parts by weight 1 to 2 hour, and each 1 to 2 hour, merging filtrate, decompression recycling ethanol, dry extract gets Radix Salviae Miltiorrhizae dry extract; Rhizoma Chuanxiong, Fructus Viticis, Rhizoma Ligustici are shredded with the Flos Chrysanthemi distillating extracting oil, and be standby, and the aqueous solution after the distillation filters, and relative density was 1.20 to 1.25 when filtrate was concentrated into 60 ℃, gets filtrate one; The medicinal residues and the Radix Paeoniae Alba, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae decoct with water three times, add 6 to 8 times of amounts of water respectively, extract 1 to 2 hour at every turn, filter, collecting decoction, relative density is 1.20 to 1.25 when being evaporated to 60 ℃, get filtrate two, filtrate two merges with filtrate one, puts coldly, and adding ethanol is 65% weight fraction to containing the alcohol amount, fully stir, leave standstill more than 20 hours, get the supernatant concentrating under reduced pressure, dryly must mix dry extract; Get Rhizoma Gastrodiae fine powder, Radix Salviae Miltiorrhizae dry extract, mixing dry extract and appropriate amount of starch, mix homogeneously sprays into volatile oil such as Rhizoma Chuanxiong, seals 3 to 5 hours, and 60 ℃ of dryings are promptly made the migrainous pharmaceutical composition of treatment.
6. the migrainous preparation of drug combination method of the described treatment of the arbitrary claim of claim 1 to 2 is characterized in that: get Rhizoma Gastrodiae powder and be broken into fine powder; Radix Salviae Miltiorrhizae adds 50% alcohol reflux twice of 7 times of parts by weight again with 85% alcohol reflux of 9 times of parts by weight 1 to 2 hour, and each 1 to 2 hour, merging filtrate, decompression recycling ethanol, dry extract gets Radix Salviae Miltiorrhizae dry extract; Rhizoma Chuanxiong, Fructus Viticis, Rhizoma Ligustici are shredded with the Flos Chrysanthemi distillating extracting oil, and the volatile oil beta-cyclodextrin inclusion compound is standby, and the aqueous solution that distills after 3 to 5 hours filters, and relative density was 1.20 to 1.25 when filtrate was concentrated into 60 ℃, got filtrate three; The medicinal residues and the Radix Paeoniae Alba, Herba Ecliptae, Fructus Ligustri Lucidi, Radix Achyranthis Bidentatae decoct with water three times, add 6 to 8 times of amounts of water respectively, extract 1 to 2 hour at every turn, filter, collecting decoction, relative density is 1.20 to 1.25 when being evaporated to 60 ℃, get filtrate two, filtrate two merges with filtrate three, puts coldly, and adding ethanol is 65% weight fraction to containing the alcohol amount, fully stir, leave standstill more than 20 hours, get the supernatant concentrating under reduced pressure, dryly must mix dry extract; Get Rhizoma Gastrodiae fine powder, Radix Salviae Miltiorrhizae dry extract, mixing dry extract and appropriate amount of starch, add Benexate Hydrochloride, mix homogeneously sealed 3 to 5 hours, and 60 ℃ of dryings are promptly made the migrainous pharmaceutical composition of treatment.
7. the purposes of the migrainous pharmaceutical composition of the described treatment of the arbitrary claim of claim 1 to 2, it is characterized in that: described pharmaceutical composition is used for suppressing the hyperactive liver to relieve the wind syndrome, blood circulation promoting and blood stasis dispelling, the migraine of treatment liver-wind folder blood stasis syndrome.
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|---|---|---|---|
| CN201010028076A CN101732585A (en) | 2010-01-12 | 2010-01-12 | Medicinal composition for treating migraine, preparation method and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010028076A CN101732585A (en) | 2010-01-12 | 2010-01-12 | Medicinal composition for treating migraine, preparation method and application thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103893570A (en) * | 2012-12-29 | 2014-07-02 | 葵花药业集团（重庆）有限公司 | Method for preparing traditional Chinese medicine capsule for treating migraine |
| CN104127854A (en) * | 2014-08-19 | 2014-11-05 | 太仓优活生物技术有限公司 | Chinese herbal medicine for treating migraine |
| CN105597069A (en) * | 2016-02-18 | 2016-05-25 | 高思山 | Traditional Chinese medicine for treating qi stagnancy and blood stasis type temporal arteritis |
| CN115998821A (en) * | 2022-12-30 | 2023-04-25 | 成都市双流区中医医院 | Headache treating bolus and its prepn |
-
2010
- 2010-01-12 CN CN201010028076A patent/CN101732585A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103893570A (en) * | 2012-12-29 | 2014-07-02 | 葵花药业集团（重庆）有限公司 | Method for preparing traditional Chinese medicine capsule for treating migraine |
| CN104127854A (en) * | 2014-08-19 | 2014-11-05 | 太仓优活生物技术有限公司 | Chinese herbal medicine for treating migraine |
| CN105597069A (en) * | 2016-02-18 | 2016-05-25 | 高思山 | Traditional Chinese medicine for treating qi stagnancy and blood stasis type temporal arteritis |
| CN115998821A (en) * | 2022-12-30 | 2023-04-25 | 成都市双流区中医医院 | Headache treating bolus and its prepn |
| CN115998821B (en) * | 2022-12-30 | 2024-03-26 | 成都市双流区中医医院 | Headache treating bolus and its prepn |
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Open date: 20100616 |