CN105709194A - Traditional Chinese medicine composition for treating stroke and external preparation thereof and preparation method of external preparation - Google Patents
Traditional Chinese medicine composition for treating stroke and external preparation thereof and preparation method of external preparation Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating a stroke and an external preparation thereof and an preparation method of the external preparation. The traditional Chinese medicine composition is prepared from 14 traditional Chinese medicines of rhizoma typhonii, earthworms, centipedes, bombyx batryticatus, rhizoma corydalis, radix angelicae dahuricae, radix angelicae sinensis, radix paeoniae rubra, rhizoma et radix notopterygii, ginger and the like, and the preparation form is adhesive plasters or cataplasms or ointments or plasters. The invention further provides the preparation method of the external preparation of the traditional Chinese medicine composition. The traditional Chinese medicine composition and the preparation thereof have the effects of dispelling wind, activating the blood, soothing channels and activating the collaterals and can be used for treating facial paralysis, drooling, stiff tongue and impeded speech, muscular numbness and arthralgia and myalgia of the stroke caused by wind pathogen and apoplexy involving the collaterals, the treatment effect is significant, the safety is high, no side effect exists, use is convenient, and the price is low.
Description
Technical field
The present invention relates to and a kind of treat the Chinese medicine composition of apoplexy, its external preparation and preparation method, belong to technical field of Chinese medicine.
Background technology
Apoplexy is the commonly encountered diseases of person in middle and old age, is that the mankind are endangered one of maximum three kind disease by the world today, is characterized in that sickness rate is high, mortality rate is high, disability rate is high, complication is many, therefore also known as " more than three-hypers one " disease, the health of the serious threat mankind.Although stroke patient is through active treatment, mostly yet suffering from sequela, i.e. apoplexy sequela, upper and lower extremities paralysis in common side is unable, munbness, and muscle is numb, facial hemiparalysis, and sialorrhea, shallow complexion, stiff tongue language is stuttering, bones and muscles pain.If not as good as early treatment, then limbs spasm gradually is stiff, and the generation useless property of limbs is tetanic, contracture, causes cacomelia and afunction etc., so improving the prophylactic treatment level of apoplexy, reducing the sickness rate of apoplexy, disability rate, treatment and the conditioning of strengthening cerebral apoplexy sequela are the task of top priority.
Apoplexy have exogenous wind and endogenous wind point, exogenous wind is because experiencing caused by external ailment said due to cold or exposure；Modern general alleged apoplexy, refer to endogenous wind more, belong to diseases caused by internal damage, also known as apoplexy, apoplexy etc., how because QI and blood is inverse disorderly, brain BI-syndrome involved the blood vessels hinders or blood oozing from the body openings or subcuta neous tissue is in caused by brain, it be suddenly faint, syncope, facial hemiparalysis, dysphonia, hemiplegia or the nothing of occurring together is fainted and the class disease that hemiplegia is cardinal symptom is occurred suddenly, and has onset urgency, change soon, such as the disease of the feature of ailment said due to cold or exposure benefaction number change.
In prior art, the Therapeutic Method for apoplexy has dietetic therapy, acupuncture, oral Chinese and Western patent medicine etc..Western medicine for anti-stroke is mainly Thrombolytic Drugs and channel blocker, has advantage rapid-action, with strong points more, but its model of action is single, and mostly can produce drug resistance and side effect, and the unsuitable long-term taking of patient, therefore long-term treatment effects is unsatisfactory.For the Chinese medicine instructed, not only there is the feature that curative effect is steady, definite, side effect is low with Chinese medical theory, and substantial amounts of scientific experiments also shows to improve the immunologic function of body, repair cranial nerve cell function, play the effect of Comprehensive Treatment；Although having many Chinese patent medicines for apoplexy at present on the market, but general dose being relatively big, cost is high, and mechanism of action is indefinite.
CN101357155A provides a kind of Traditional Chinese medicine liniment treating apoplexy.CN104784398A discloses a kind of external-applied ointment treating apoplexy sequela.This type of Chinese medicine for external application all to embrocate, the mode such as stranding use, dosage is big and uses and is inconvenient for.
Summary of the invention
For the deficiencies in the prior art, the present invention provides a kind of Chinese medicine composition treating apoplexy and external preparation thereof.
This medicine and preparation have and dispel the wind, invigorate blood circulation, soothing the channels and quicking the network vessels effect, can be used for treating the facial hemiparalysis of apoplexy caused by ailment said due to cold or exposure appoplexy involving the collateral, sialorrhea, stiff tongue language is stuttering, muscle is numb, the treatment of bones and muscles pain, its therapeutic effect is notable, safety is high, has no side effect, easy to use, cheap.All medicine reasonable compatibilities in the present invention, complementary collaborative, dialectical treatment, the various symptoms for Sequela of Strike have good curative effect, overcome existing treatment apoplexy medicine above shortcomings.
The preparation method that the present invention also provides for the Chinese medicine composition external preparation of this treatment apoplexy.
Technical scheme is as follows:
A kind of external medicine composition treating apoplexy, is made up of the raw material of following weight portion:
Rhizoma Typhonii 20-100 part, Pheretima 20-100 part, Scolopendra 10-80 part, Bombyx Batryticatus 10-80 part, Rhizoma Corydalis 10-80 part, Radix Angelicae Dahuricae 20-80 part, Radix Angelicae Sinensis 10-80 part, Radix Paeoniae Rubra 10-80 part, Rhizoma Et Radix Notopterygii 20-100 part, Rhizoma Zingiberis Recens 20-100 part, Camphora 5-20 part, Borneolum Syntheticum 5-20 part, Mentholum 1-10 part, thymol 1-10 part.
According to currently preferred, the external medicine composition of described treatment apoplexy, it is made up of the raw material of following weight portion:
Rhizoma Typhonii 20-80 part, Pheretima 20-80 part, Scolopendra 10-60 part, Bombyx Batryticatus 10-60 part, Rhizoma Corydalis 20-60 part, Radix Angelicae Dahuricae 20-60 part, Radix Angelicae Sinensis 10-50 part, Radix Paeoniae Rubra 10-50 part, Rhizoma Et Radix Notopterygii 20-70 part, Rhizoma Zingiberis Recens 20-70 part, Camphora 5-15 part, Borneolum Syntheticum 5-15 part, Mentholum 2-10 part, thymol 2-10 part.
According to the present invention, a preferred embodiment, the external medicine composition of described treatment apoplexy, it is made up of the raw material of following weight portion:
Rhizoma Typhonii 50 parts, Pheretima 50 parts, Scolopendra 50 parts, Bombyx Batryticatus 50 parts, Rhizoma Corydalis 40 parts, the Radix Angelicae Dahuricae 40 parts, Radix Angelicae Sinensis 40 parts, Radix Paeoniae Rubra 40 parts, Rhizoma Et Radix Notopterygii 40 parts, 30 parts of Rhizoma Zingiberis Recens, Camphora 10 parts, Borneolum Syntheticum 10 parts, Mentholum 5 parts, thymol 5 parts.
According to the present invention, another preferred embodiment, the external medicine composition of described treatment apoplexy, it is made up of the raw material of following weight portion:
Rhizoma Typhonii 60 parts, Pheretima 60 parts, Scolopendra 50 parts, Bombyx Batryticatus 50 parts, Rhizoma Corydalis 50 parts, the Radix Angelicae Dahuricae 40 parts, Radix Angelicae Sinensis 40 parts, Radix Paeoniae Rubra 30 parts, Rhizoma Et Radix Notopterygii 30 parts, 30 parts of Rhizoma Zingiberis Recens, Camphora 5 parts, Borneolum Syntheticum 10 parts, Mentholum 10 parts, thymol 5 parts.
According to the present invention, another preferred embodiment, the external medicine composition of described treatment apoplexy, it is made up of the raw material of following weight portion:
Rhizoma Typhonii 50 parts, Pheretima 50 parts, Scolopendra 60 parts, Bombyx Batryticatus 60 parts, Rhizoma Corydalis 30 parts, the Radix Angelicae Dahuricae 30 parts, Radix Angelicae Sinensis 30 parts, Radix Paeoniae Rubra 40 parts, Rhizoma Et Radix Notopterygii 40 parts, 40 parts of Rhizoma Zingiberis Recens, Camphora 10 parts, Borneolum Syntheticum 5 parts, Mentholum 10 parts, thymol 5 parts.
In each component of above-mentioned Chinese medicine composition:
Rhizoma Typhonii, for the dry tuber of aroid Herba Typhonii gigantei TyphoniumgiganteumEngl..Effect is dispeled the wind expectorant, and arresting convulsion is jerked, detoxicating and resolving stagnation of pathogens, pain relieving.Stopping up for middle wind-phlegm, mouth eye is oblique, dysphasia, infantile convulsion epilepsy, tetanus, and syncope due to accumulation of phlegm is had a headache, migraine and general headache, scrofula sucutaneous nodule, venom.
Pheretima, for the dry body of Ju Yin section animal Pheretima aspergillum Pheretimaaspergillum (E.Perrier), popular Pheretimatschiliensis PheretimavulgarisChen, power simulation Pheretimaguillelmi (Michaelsen) or the blind Pheretimatschiliensis PheretimapectiniferaMichaelsen of comb.Effect heat clearing away is calmed the frightened, and dredging collateral is relievingd asthma, diuresis.For unconsciousness due to high fever, infantile convulsion is twitched, arthralgia, numb limbs and tense tendons, hemiplegia, dyspnea and cough due to lung-heat, edema oliguria.
Scolopendra, for the dry body of Scolopendridae animal Scolopendpa Subspinipes Mutilans L. KOCH ScolopendrasubspinipesmutilansL.Koch.Effect endogenous wind stopping spasmolytic, removing obstruction in the collateral to relieve pain, dispersing pathogen accumulation.For liver-wind stirring up internally, spasm is twitched, infantile convulsion, middle air port, hemiplegia, tetanus, rheumatoid arthritis stubborn, migraine and general headache, skin infection, scrofula, snake bite and insect sting.
Bombyx Batryticatus, infects (or artificial vaccination) muscardine Beauveriaassiana (Bals.) Vuillant and lethal dry body for the larva in Bombycidae insecticide silkworm BombyxmoriLinnaeus4～5 ages.Effect endogenous wind stopping relieving convulsion, wind-expelling pain-stopping, dissipating phlegm and resolving masses.Pressing from both sides expectorant for liver-wind, infantile convulsion is twitched, acute infantile convulsion, tetanus, middle air port, headache due to pathogenic wind-heat, conjunctival congestion pharyngalgia, rubella pruritus, maxillofacial sore mumps.
Rhizoma Corydalis, for the dry tuber of papaveraceae plant corydalis CorydalisyanhusuoW.T.Wang.Effect is invigorated blood circulation, circulation of qi promoting, pain relieving.For the breast side of body, epigastric pain, obstruction of qi in the chest and cardialgia, amenorrhea dysmenorrhea, postpartum stagnation, tumbling and swelling.
The Radix Angelicae Dahuricae, for the dry root of samphire Radix Angelicae Dahuricae Angelicadahurica (Fisch.exHoffm.) Benth.etHook.f. or Radix angelicae dahuricae Angelicadahurica (Fisch.exHoffm.) Benth.etHook.f.var.formosana (Boiss.) ShanetYuan.Effect is induced sweat cold expelling, wind-expelling pain-stopping, declares clearing the nasal passage, dampness leukorrhagia stopping, detumescence and apocenosis.For headache due to common cold, supraorbital bone pain, watery nasal discharge of having a stuffy nose, allergic rhinitis, nasal sinusitis, toothache, leukorrhagia, skin infection swells and ache.
Radix Angelicae Sinensis, for the dry root of umbelliferae angelica Angelicasinensis (Oliv.) Diels.Effect replenishing and activating blood, menstruction regulating and pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizziness cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, rheumatic arthralgia, injury from falling down, ulcer sores, dryness of the intestine constipation.
Radix Paeoniae Rubra, for the dry root of ranunculaceae plant Radix Paeoniae PaeonialactifloraPall. or river Radix Paeoniae Rubra PaeoniaveitchiiLynch.Effect clearing away heat and cooling blood, eliminating stasis to stop pain.Entering nutrient blood, maculae caused by violent heat pathogen, hematemesis and epistaxis, conjunctival congestion and swelling pain, hypochondriac pain due to stagnation of liverQI, amenorrhea dysmenorrhea for heat, abdominal mass is suffered from abdominal pain, injury from falling down, carbuncle skin infection.
Rhizoma Et Radix Notopterygii, for dry rhizome and the root of samphire Rhizoma Et Radix Notopterygii NotopterygiumincisumTingexH.T.Chang or Radix et Rhizoma Notopterygii NotopterygiumfranchetiiH.deBoiss..Effect is induced sweat cold expelling, expelling wind and removing dampness, pain relieving.For anemofrigid cold, stiffness of the nape of having a headache, rheumatic arthralgia, aching pain in shoulder and back.
Rhizoma Zingiberis Recens, for the fresh rhizome of zingiber ZingiberofficinaleRosc..Effect is induced sweat cold expelling, warming middle-JIAO to arrest vomiting, preventing phlegm from forming and stopping coughing, solving toxin of fish and crab.For anemofrigid cold, gastrofrigid vomiting, cold-phlegm is coughed, and fish Eriocheir sinensis is poisoning.
Camphora, composition is (1R, 4R)-1,7,7-trimethyl bicyclo-[2.2.1] heptane-2-ketone, is extract to prepare in canella.This product is dermerethistica.
Borneolum Syntheticum, for borneolum syntheticum, effect is had one's ideas straightened out refreshment, clearing away heat to alleviate pain.For calentura coma, convulsions, apoplexy syncope due to accumulation of phlegm, stagnation of QI sudden syncope, attacked by pestiferous factors is gone into a coma, and obstruction of qi in the chest and cardialgia, conjunctival congestion, aphtha, laryngopharynx swelling and pain, auditory meatus is suppurated.
Mentholum, a kind of saturated cyclic alcohol that this product is the fresh stem of labiate Herba Menthae MenthahaplocalyxBriq. and Ye Jing vapor distillation, freezing, recrystallization obtain, for l-1-methyl-4-isopropyl cyclohexanol-3.
Thymol, composition is 5-isopropyl phenol.This product is Cidex-7, is mainly used in fungal infection.
The prescription of the present invention is made up of Rhizoma Typhonii, Pheretima, Scolopendra, Bombyx Batryticatus, Rhizoma Corydalis, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Et Radix Notopterygii, Rhizoma Zingiberis Recens, Camphora, Borneolum Syntheticum, Mentholum, thymol.The reasonable scientific compatibility of each component of the present invention, complementary collaborative, dialectical treatment, the various symptoms for Sequela of Strike have good curative effect.The present inventor, according to the cause of disease of this type of disease and pathogenesis, is studied by modern pharmacology, test result indicate that scientific and reasonable compatibility, and medicine can not only be made to play the collaborative reinforced effects of drug effect, and can also significantly reduce medicine make consumption.
According to the present invention, a kind of Chinese medicine composition external preparation, its dosage form is rubber-emplastrum, cataplasma, ointment or plaster.
The external medicine composition of the present invention and preparation thereof are for treating the external used medicine of apoplexy sequela patient, during use, the preparations such as rubber-emplastrum, cataplasma, ointment or plaster are sticked or are coated on the relevant acupuncture point of Ipsilateral.Before sticking, by relevant acupuncture point place's warm water cleaning or alcohol disinfecting.
According to the present invention, the preparation method of a kind of Chinese medicine composition external preparation, comprise the steps:
(1) weigh each raw material components in proportion, pulverize；Taking Rhizoma Typhonii therein, Pheretima, Scolopendra, Bombyx Batryticatus, Rhizoma Corydalis, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Et Radix Notopterygii, Rhizoma Zingiberis Recens mixing, gained mixed powder alcohol solvent extracts, concentration, makes Chinese medicine fluid extract, standby；
(2) taking paste substrate, add Chinese medicine fluid extract and Camphora, Borneolum Syntheticum, Mentholum, the thymol of step (1), glue cream is made in refine.
Described paste substrate is rubber-emplastrum substrate, ground substance of plaster ointment, ointment base or plaster substrate.The material composition of shown substrate is by state of the art.The present invention is preferably as follows substrate:
A. rubber-emplastrum substrate: the mixing thing of rubber, Colophonium, zinc oxide and vaseline and/or lanoline；
B. ground substance of plaster ointment: sodium polyacrylate, sodium carboxymethyl cellulose, citric acid, polyvidone, glycerol and micropowder silica gel；
C. ointment base: stearic acid, glyceryl monostearate, glycerol, Polysorbate and triethanolamine soaps；
D. plaster substrate: Oleum Sesami and Plumbum preparatium.
According to the preparation method that the present invention is above-mentioned, it is preferable that step (1) is that to carry out extraction be adopt percolation to carry out percolation to solvent with ethanol, collects percolate, concentrating under reduced pressure, reclaim ethanol, make Chinese medicine fluid extract.Further preferred that
Described alcohol solvent volumetric usage is 1-1.5 times of mixed powder gross mass, volume: mass ratio unit is ml/g or rise/kilogram.After mixed powder and alcohol solvent being stirred, airtight placement infiltrates 1-3 hour, makes medical material fully expand；Then take the mixed powder after infiltration and load percolator, add alcohol solvent and continue airtight placement dipping 24～48 hours, make the abundant diffusion of solvent, then proceed by percolation.
Preferably, when the mixed powder after above-mentioned infiltration loads percolator, mixed powder gradation is uniformly loaded percolator (degree of tightness is suitable for)；Open percolator end opening switch, slowly add alcohol solvent, the closing switch when there being liquid to flow out from end opening from top, to get rid of the interstitial air of medicated powder, continuously add alcohol solvent to exceeding mixed powder upper surface 1-10 centimetre.
Preferably, above-mentioned when proceeding by percolation, control percolation speed, make effluent per hour be equivalent to the 1/48～1/24 of percolator dischargeable capacity, and constantly add alcohol solvent from top, keep solvent liquid level higher than mixed powder upper surface.Collect 5～6 times amount that percolate volume is mixed powder gross mass, unit: ml/g, or rise/kilogram.
According to the preparation method that the present invention is above-mentioned, it is preferable that in step (1), described thickening temperature is 50～85 DEG C.The relative density of described Chinese medicine fluid extract is 1.05～1.10, and reference density is water, 50～65 DEG C of surveys.
According to the preparation method that the present invention is above-mentioned, it is preferable that in step (1), described alcohol solvent is the ethanol of volume fraction 70-90, it is preferred that the ethanol of volume fraction 85%.
According to the preparation method that the present invention is above-mentioned, it is preferable that in described step (1), described crude drug is ground into coarse powder, whole mistake 24 mesh sieves and wherein can cross 65 mesh sieves less than the 40% of coarse powder gross mass.
According to the preparation method that the present invention is above-mentioned, when dosage form is rubber-emplastrum, cataplasma or plaster, also include step (3): take glue cream prepared by step (2) and be coated on backing cloth, cutting, lid lining (sealing coat), section, encapsulation.
Chinese medicine preparation be prepared by a complicated system, particularly extract, technological parameter in concentration different, obtained ingredient is just different, is thus told on also different.Currently preferred preparation process thereof step and parameter declaration are as follows:
The granularity that Raw medicated powder of the present invention is broken into medicated powder has special requirement, most widely suited to be ground into coarse powder, and described coarse powder refers to all through 24 mesh sieves, but is wherein mixed with a little fine powder that can pass through 65 mesh sieves, the fine powder total amount powder less than 40%.As medicated powder is excessively thick, not easily compressing during dress percolator (cylinder), during percolation, solvent-oil ratio is big, leaches composition incomplete, and leaching effect is poor；Easy blocking percolator as meticulous in medicated powder, affects percolation speed, and extraction efficiency is low.
In the present invention, preferred percolation and concentrating under reduced pressure prepare Chinese medicine fluid extract has special requirement to medicated powder immersion and percolation operation, the medical material that appropriateness is pulverized is put in percolator, solvent is constantly added by top, solvent oozed the method leaching medicinal ingredient in the dynamic process of medical material sulfate layer flows downhill, Dynamic Leaching extracts, solvent utilization rate is high, effective ingredient leaches completely, and can directly collect leachate, compared with decocting cooking method, the composition unrelated with therapeutical effect such as polysaccharide can be substantially reduced, protein, tannin, the proposition of phlegmatic temperament etc., it also avoid postorder and remove the tedious steps of invalid components, reduce cost, improve economic benefit；Preparing Chinese medicine fluid extract in conjunction with concentrating under reduced pressure, during percolate concentration, heating-up temperature is low, and heated time is short, and effective ingredient destroys few, and reservation is many, keeping curative effect simultaneously, can reduce again the volume of manufactured goods.Medicated powder infiltration, charging, dipping and percolation technological parameter main points: 1. infiltration medicated powder: appropriate wet with solvent should first be used by medicated powder, so as to fully expand, it is to avoid expand at percolator Chinese medicine powder and result in blockage；2. charging: the medicated powder gradation of swells is loaded percolator, answers degree of tightness to be suitable for, uniformly flattens；First open percolator end opening switch during solubilizer, add solvent from medicated powder top and flow out from outlet to percolate, get rid of the interstitial air of medicated powder, continue solubilizer submergence medicated powder surface several centimeters, close percolate outlet.3. medicated powder dipping: impregnate 24～48h in percolator, make the abundant diffusion of solvent, be beneficial to the leaching of effective ingredient during percolation.4. percolation speed: during percolation, controls percolation speed, percolation excessive velocities, leaches composition incomplete, consume quantity of solvent big；Speed is excessively slow, affects extraction efficiency.
Beneficial effects of the present invention:
1, Chinese medicine composition of the present invention is that one has and dispels the wind, invigorates blood circulation, the Chinese medicine for external application of soothing the channels and quicking the network vessels effect, for treating the muscular paralysis of apoplexy caused by ailment said due to cold or exposure appoplexy involving the collateral, Bekhterev's symptom and through contraction disease, disease sees facial hemiparalysis, sialorrhea, stiff tongue language is stuttering, muscle is numb, bones and muscles pain etc., its therapeutic effect is notable.The treatment of this disease at present, the therapies such as oral drugs such as meticorten, and acupuncture-moxibustion that adopt more, take inconvenience, side effect is big, unsuitable life-time service.Selecting rubber-emplastrum, cataplasma, ointment or plaster to stick acupuncture point and affected part local application, by Transdermal absorption, the meridians made regulate and reach therapeutical effect, have safety height, have no side effect, advantage easy to use.
2, containing multi-medicament component in Chinese medicine composition of the present invention, by being pasted on the relevant acupuncture point of patient, Transdermal absorption, action target spot is numerous, as sticked Sibai, Yingxiang, the sun, ShiShimonoseki, the medium acupoint therapy facial hemiparalysis of people, stick the acupoint therapy muscle such as chize, connected valleys, shou san li, tsu san li, gb 34 numb, stick Ashi point treatment bones and muscles pain etc., compared with existing Chinese medicine rapid-action, sphere of action is wide.Pharmacodynamics test shows: after this drug percutaneous skin absorbs, local big and small vessel is had and substantially expands use, make blood flow increase, local muscle has the impact of physiological property.Animal experiment proves, this product can increase rabbit sciatic nerves motor conduction velocity, can shorten incubation period；Evoked ptential action time-histories can be shortened；Evoked ptential wave amplitude height can be improved, so neural quickening conduction velocity can be made and improves irritability.
3, the Chinese medicine for external application preparation method of the present invention, take into full account the effective ingredient of each component, at utmost to retain effective ingredient, adopt percolation and the concentrating under reduced pressure technology of advanced person simultaneously, both improve production efficiency, shorten man-hour, reduce again energy consumption, achieve the combination of comprehensive Social benefit and economic benefit.
Detailed description of the invention
Below in conjunction with embodiment, technical scheme is described further, but institute of the present invention protection domain is not limited to this.Raw material in embodiment is commercially available product, and wherein said " volume: quality " proportional units is ml/g or rise/kilogram.
Embodiment 1
The rubber-emplastrum of a kind of Chinese medicine composition treating apoplexy, is made up of the material component of following weight parts:
Rhizoma Typhonii 50 parts, Pheretima 50 parts, Scolopendra 50 parts, Bombyx Batryticatus 50 parts, Rhizoma Corydalis 40 parts, the Radix Angelicae Dahuricae 40 parts, Radix Angelicae Sinensis 40 parts, Radix Paeoniae Rubra 40 parts, Rhizoma Et Radix Notopterygii 40 parts, 30 parts of Rhizoma Zingiberis Recens, Camphora 10 parts, Borneolum Syntheticum 10 parts, Mentholum 5 parts, thymol 5 parts.
The preparation method of the rubber-emplastrum of this Chinese medicine composition described, comprises the steps:
1, weigh each raw material components in proportion, Rhizoma Typhonii therein, Pheretima, Scolopendra, Bombyx Batryticatus, Rhizoma Corydalis, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Et Radix Notopterygii, Rhizoma Zingiberis Recens powder are broken into coarse powder, standby；
2, taking the mixing of above-mentioned coarse powder, add the ethanol of volume fraction 85%, ethanol dosage is the 1 times amount volume (proportional units for ml/g) of coarse powder gross weight, after stirring, and airtight placement infiltration 2～3 hours；Then the medicine coarse powder gradation of infiltration is uniformly loaded percolator, make degree of tightness be suitable for；Open percolator end opening switch, the ethanol of volume fraction 85% is slowly added from top, the closing switch when liquid flows out from end opening, continuously add solvent paramount go out above medicated powder 3-5 centimetre, airtight dipping of placing, after 48 hours, carries out percolation, and controlling percolation speed is that effluent is approximately equivalent to the 1/24 of percolator dischargeable capacity and is advisable per hour, and alcohol solvent is constantly added from top, keep alcohol solvent higher than medicated powder upper surface.Collect 5 times amount that percolate volume is mixed powder gross mass, volume/mass unit: ml/g；Stop percolation.The percolate concentrating under reduced pressure collected, reclaims ethanol, controls thickening temperature 50～85 DEG C, is concentrated into the Chinese medicine fluid extract that relative density is 1.07～1.10 (50 DEG C of surveys, reference density is water), standby.
3, taking rubber and carry out pretreatment, plasticating in rubber mixing machine reticulates thin slice, then carries out mixing with Colophonium, zinc oxide, vaseline, lanoline, obtains rubber mass.
4, take mixing after rubber mass, add the Camphora pulverized, Chinese medicine fluid extract that Borneolum Syntheticum, Mentholum, thymol and step 2 prepare, glue cream is made in refine.
5, take glue cream and be coated on backing cloth, cutting, lid lining (sealing coat), cut into pieces, encapsulation, to obtain final product.
Embodiment 2, a kind of Chinese medicine preparation treating apoplexy, be made up of the material component of following weight parts:
Rhizoma Typhonii 60 parts, Pheretima 60 parts, Scolopendra 50 parts, Bombyx Batryticatus 50 parts, Rhizoma Corydalis 50 parts, the Radix Angelicae Dahuricae 40 parts, Radix Angelicae Sinensis 40 parts, Radix Paeoniae Rubra 30 parts, Rhizoma Et Radix Notopterygii 30 parts, 30 parts of Rhizoma Zingiberis Recens, Camphora 5 parts, Borneolum Syntheticum 10 parts, Mentholum 10 parts, thymol 5 parts.
The preparation method that above-mentioned external medicine composition is made rubber-emplastrum, step is as follows:
Step 1: with embodiment 1；
Step 2: take the mixing of above-mentioned coarse powder, adds the ethanol (ethanol volume: the proportional units of coarse powder gross weight be ml/g) of coarse powder gross weight 1 times amount 70%, after stirring, and airtight placement infiltration 1～2 hour；Then the flavour of a drug coarse powder gradation of infiltration is uniformly loaded percolator, make degree of tightness be suitable for；Open percolator end opening switch again, the ethanol of volume fraction 70% is slowly added from top, the closing switch when liquid flows out from end opening, continuously add solvent paramount go out 6 centimetres of medicated powder face, airtight dipping of placing, after 24 hours, carries out percolation, and controlling percolation speed is that effluent is approximately equivalent to the 1/48 of the effective container of percolator and is advisable per hour, and alcohol solvent is constantly added from top, keep solvent higher than medicated powder upper surface.Collect 6 times amount that percolate volume is mixed powder gross mass, volume/mass unit: ml/g；The percolate concentrating under reduced pressure collected, reclaims ethanol, controls thickening temperature 50～85 DEG C, is concentrated into the Chinese medicine fluid extract that relative density is 1.05～1.08 (65 DEG C of surveys, reference density is water), standby.
Step 3-5: identical with embodiment 1.
Embodiment 3, a kind of Chinese medicine composition external preparation (cataplasma) treating apoplexy, be made up of the material component of following weight parts:
Rhizoma Typhonii 50 parts, Pheretima 50 parts, Scolopendra 60 parts, Bombyx Batryticatus 60 parts, Rhizoma Corydalis 30 parts, the Radix Angelicae Dahuricae 30 parts, Radix Angelicae Sinensis 30 parts, Radix Paeoniae Rubra 40 parts, Rhizoma Et Radix Notopterygii 40 parts, 40 parts of Rhizoma Zingiberis Recens, Camphora 10 parts, Borneolum Syntheticum 5 parts, Mentholum 10 parts, thymol 5 parts.
Above-mentioned Chinese medicine composition is made cataplasma, and its preparation methods steps is as follows:
1, weighing each raw material components in proportion, Rhizoma Typhonii therein, Pheretima, Scolopendra, Bombyx Batryticatus, Rhizoma Corydalis, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Et Radix Notopterygii, Rhizoma Zingiberis Recens powder are broken into coarse powder, mixing uniformly, obtains mixed powder, standby；
2, take described mixed powder, add the alcohol solvent (ethanol volume: the proportional units of coarse powder gross weight be ml/g) of mixed powder gross mass 1 times amount, described alcohol solvent volume fraction 80%, after stirring, airtight placement infiltration 2～3 hours；Then the flavour of a drug coarse powder gradation of infiltration is uniformly loaded percolator, make degree of tightness be suitable for；Open percolator end opening switch again, 80% alcohol solvent is slowly added from top, the closing switch when liquid flows out from end opening, continuously add solvent paramount go out 6 centimetres of medicated powder face, airtight dipping of placing, after 36 hours, carries out percolation, and controlling percolation speed is that effluent is approximately equivalent to the 1/36 of percolator dischargeable capacity and is advisable per hour, and described alcohol solvent is constantly added from top, keep solvent higher than medicated powder upper surface.Collect 5.5 times amount that percolate volume is mixed powder gross mass, volume/mass unit: ml/g；The percolate concentrating under reduced pressure collected, reclaims ethanol, controls thickening temperature 50～85 DEG C, is concentrated into the Chinese medicine fluid extract that relative density is 1.06～1.09 (60 DEG C of surveys, reference density is water), standby.
3, take sodium polyacrylate, sodium carboxymethyl cellulose, citric acid, polyvidone, glycerol and micropowder silica gel host material and carry out mixing, make uniform ground substance of plaster ointment.
4, take mixing after ground substance of plaster ointment, add the Camphora pulverized, Chinese medicine fluid extract that Borneolum Syntheticum, Mentholum, thymol and step 2 prepare, glue cream is made in refine.
5, take glue cream and be coated on backing cloth, cutting, lid lining (sealing coat), section, encapsulation.
Experimental example 1, tuerculoderma
External medicine composition preparation for reagent product: embodiment of the present invention 1-3
1, Skin Irritation Test: experimental animal is rabbit.
Test method: take rabbit 24 (each use of experiment 8 of each embodiment), body weight 2.0～2.3kg, ♀ ♂ dual-purpose, in being administered first 24 hours by animal spinal column both sides unhairing, every day is administered twice, administration district, left side, right side blank Matrix controls district, continuous 7 days, observes dermoreaction situation every day, examine with or without erythema, edema, protuberance, eschar formation etc., Continuous Observation 3 days again after drug withdrawal.
Result of the test: rabbit was successive administration 7 days, and agents area skin has no rubescent, the irritative symptoms such as erythema, edema does not occur, compare with bare substrate check plot and have no obvious diversity, after all rabbit skin drug withdrawals 72 hours, also have no erythema and edema, also have no pigmentation etc..Other symptom all no abnormality seens such as the rabbit mental status, activity, breathing, food ration, body weight, outward appearance, stool, urine shape and color, dorsal body setae, the colour of skin, nose, eye, oral cavity also secretions without exception, it was demonstrated that for reagent product without skin wound repair.
2, skin anaphylactic test: experimental animal is albino guinea-pig.
Extracting waste Cavia porcellus, male and female half and half, body weight 290～320g, takes off in administration for first 24 hours by guinea pig back spinal column diamond wool.Experimental animal is randomly divided into 5 groups, often 10 (male and female half and half) of group, each treated animal coats tested material (first group respectively, second group and the 3rd group respectively embodiment 1, 2, 3), bare substrate (the 4th group), 1%2.4-dinitrochlorobenzene (the 5th group, positive controls) it was repeated once every 2 hours, coating is washed away with clear water after 6 hours, all animals all sub-cage rearings, 7th day, within 14th day, it is repeated once, in provocative test in the 28th day, opposite side tested material respectively at experimental animal spinal column, bare substrate, 0.1%2.4-dinitrochlorobenzene, coating is removed after 6 hours, i.e. observable skin allergy situation, afterwards in 24 hours, 48 hours, within 72 hours, again observe anaphylaxis situation, with reference to dermoreaction standards of grading, observe with or without erythema, edema, animal is stood situation, whether there is asthma, shock etc..Skin anaphylactic test result: administration group (first group, second group and the 3rd group), bare substrate (the 4th group) are without anaphylaxiss such as erythema, edema, animal astasia, asthma and shocks, positive controls (the 5th group) sensitization rate reaches 100%, it was demonstrated that for reagent product without skin allergy.
Experimental example 2, clinical trial
Therapeutic Method: external curing apoplexy sequela patient, is pasted on the relevant acupuncture point of Ipsilateral.Before sticking, by relevant acupuncture point place's warm water cleaning or alcohol disinfecting.
The diagnostic criteria of apoplexy sequela:
1. primary symptom: hemiplegia, crooked mouth and tongue, god knows unconsciousness, and stiff tongue speech is not smoothgoing or in silence, hemianesthesia；
2. Acute onset；
3. sick sending out has inducement more, often has premonitory symptom before not sending out；
4. send out well the age many more than 40 years old；
Having primary symptom two or more, Acute onset, namely the feature in conjunction with aspects such as tongue, arteries and veins, inducement, tendency, ages can determine that diagnosis, does not possess conditions above, also can make a definite diagnosis in conjunction with imaging examination result.
Staging scale:
1. acute stage: after morbidity within 2 weeks.Hitting Viscera is the longest to 1 month.
2. convalescent period: fall ill 2 weeks or within 1 month to half a year.
3. sequela stage: more than half a year of falling ill.
Effect for the treatment of sequela of apoplexy evaluation criteria:
Adopt scoring method: be conceived to the recovery extent of mind, language, motor function.
One, point system:
1. mind state: conscious 4 points；Staring spells (drowsy, wake up after can and people's words) 3 points；Mind mist (drowsiness, exhale answer imprecise) 2 points；Coma 1 point；Muddle-headed (coma has the depletion syndrome concurrently simultaneously) 0 point.
2. language performance: normal 4 points；General Expression, anomia 3 points；Speak and form a complete sentence and express incomplete 2 points；Word, phrase 1 point can not be said；Language can not or substantially can not 0 point.
3. upper limb shoulder joint: normal 4 points；Upper act is complete and muscular strength differs from 3 points；Upper act is flat takes on or skips over shoulder 2 points；Upper act is less than shoulder 1 point；Inactive or front and back slightly swing 0 point.
4. upper limb articulations digitorum manus: normal 4 points；Finger action respectively effectively and muscular strength differs from 3 points；Clench fist and stretch 2 points of finger；Count on one's fingers, can not hold fist, 1 point will not be stretched；0 point will not be moved.
5. lower limb hip joint: normal 4 points；Raise more than 45 ° 3 points；Less than 45 ° 2 points；Swing can translate 1 point；Inactive 0 point.
6. lower limb toe joint: normal 4 points；Stretch and bend freely, weak 3 points of power；Stretch and bend incomplete 2 points；Slightly dynamic 1 point；0 point will not be moved.
7. comprehensive function: life can be taken care of oneself, open end interview 4 points；Live on one's own life simple work and have incomplete 3 points of partial function；Can walking, partial self-help, the people that still needs assists 2 points；Can stand and take a step, need people to take care of 1 point at any time；Lie in bed 0 point.
Two, efficacy evaluation:
Full marks 28 points, starting point is divided the highest less than 18 points, its efficacy evaluation:
1. worsen: aggravation integration reduces or died；
2. invalid: integration increases less than 4 points of persons；
3. effective: integration increases above more than 4 points persons；
4. effective: integration increases above 10 points of persons；
5. it is almost recovered: integration reaches more than 24 points persons.
Three, clinical trial:
1. treatment group:
A. applying the external medicine composition preparation for treating apoplexy sequela of the embodiment of the present invention 1, be pasted on the relevant acupuncture point of Ipsilateral, treatment cycle is three months.Treating altogether after 354 example apoplexy in disease patient, male patient 252 example, female patient 102 example, the age is between 40 years old～70 years old.Be almost recovered 64 examples, cure rate 18.1%；Effective 178 examples, obvious effective rate 50.3%；Effective 319 examples, effective percentage 90.1%；Invalid 35 examples, inefficiency 9.9%, worsens 0 example.Total effective rate is 90.1%.
B. the external medicine composition preparation for treating apoplexy sequela applying the embodiment of the present invention 2 is pasted on the relevant acupuncture point of Ipsilateral, and treatment cycle is three months.Treating altogether after 307 example apoplexy in disease patient, male patient 213 example, female patient 94 example, the age is between 40 years old～75 years old.Be almost recovered 54 examples, cure rate 17.6%；Effective 154 examples, obvious effective rate 50.2%；Effective 278 examples, effective percentage 90.6%；Invalid 29 examples, inefficiency 9.4%, worsens 0 example.Total effective rate is 90.6%.
C. the external medicine composition preparation for treating apoplexy sequela applying the embodiment of the present invention 3 is pasted on the relevant acupuncture point of Ipsilateral, and treatment cycle is three months.Treating altogether after 323 example apoplexy in disease patient, male patient 225 example, female patient 98 example, the age is between 40 years old～70 years old.Be almost recovered 57 examples, cure rate 17.7%；Effective 159 examples, obvious effective rate 49.2%；Effective 293 examples, effective percentage 90.7%；Invalid 30 examples, inefficiency 9.3%, worsens 0 example.Total effective rate is 90.7%.
2. matched group: selecting areal apoplexy sequela patient 90 example, the age is between 40～75 years old.Male patient 70 example, women 20 example, application hospital routine western medicines in treatment three months is treatment cycle.Be almost recovered 10 examples, cure rate 11.1%；Effective 32 examples, obvious effective rate 35.6%；Effective 74 examples, effective percentage 82.2%；Invalid 16 examples, inefficiency 17.8%, worsens 0 example.Total effective rate is 82.2%.
Statistical result shows: treatment group and matched group significant difference.Clinical trial shows: Chinese medicine composition of the present invention is that one has and dispels the wind, invigorates blood circulation, the Chinese medicine preparation of soothing the channels and quicking the network vessels effect, this medicine reasonable compatibility, complementary collaborative, dialectical treatment, can be used for treating the muscular paralysis of apoplexy caused by ailment said due to cold or exposure appoplexy involving the collateral, Bekhterev's symptom and through contraction disease, disease sees facial hemiparalysis, sialorrhea, stiff tongue language is stuttering, muscle is numb, bones and muscles pain etc., and effect is notable.
Claims (10)
1. the external medicine composition treating apoplexy, it is characterised in that be made up of the raw material of following weight portion:
Rhizoma Typhonii 20-100 part, Pheretima 20-100 part, Scolopendra 10-80 part, Bombyx Batryticatus 10-80 part, Rhizoma Corydalis 10-80 part, Radix Angelicae Dahuricae 20-80 part, Radix Angelicae Sinensis 10-80 part, Radix Paeoniae Rubra 10-80 part, Rhizoma Et Radix Notopterygii 20-100 part, Rhizoma Zingiberis Recens 20-100 part, Camphora 5-20 part, Borneolum Syntheticum 5-20 part, Mentholum 1-10 part, thymol 1-10 part.
2. the external medicine composition treating apoplexy as claimed in claim 1, it is characterised in that be made up of the raw material of following weight portion: Rhizoma Typhonii 20-80 part, Pheretima 20-80 part, Scolopendra 10-60 part, Bombyx Batryticatus 10-60 part, Rhizoma Corydalis 20-60 part, Radix Angelicae Dahuricae 20-60 part, Radix Angelicae Sinensis 10-50 part, Radix Paeoniae Rubra 10-50 part, Rhizoma Et Radix Notopterygii 20-70 part, Rhizoma Zingiberis Recens 20-70 part, Camphora 5-15 part, Borneolum Syntheticum 5-15 part, Mentholum 2-10 part, thymol 2-10 part.
3. the external medicine composition treating apoplexy as claimed in claim 1, it is characterised in that be made up of the raw material of following weight portion: Rhizoma Typhonii 50 parts, Pheretima 50 parts, Scolopendra 50 parts, Bombyx Batryticatus 50 parts, Rhizoma Corydalis 40 parts, the Radix Angelicae Dahuricae 40 parts, Radix Angelicae Sinensis 40 parts, Radix Paeoniae Rubra 40 parts, Rhizoma Et Radix Notopterygii 40 parts, 30 parts of Rhizoma Zingiberis Recens, Camphora 10 parts, Borneolum Syntheticum 10 parts, Mentholum 5 parts, thymol 5 parts；Or,
Rhizoma Typhonii 60 parts, Pheretima 60 parts, Scolopendra 50 parts, Bombyx Batryticatus 50 parts, Rhizoma Corydalis 50 parts, the Radix Angelicae Dahuricae 40 parts, Radix Angelicae Sinensis 40 parts, Radix Paeoniae Rubra 30 parts, Rhizoma Et Radix Notopterygii 30 parts, 30 parts of Rhizoma Zingiberis Recens, Camphora 5 parts, Borneolum Syntheticum 10 parts, Mentholum 10 parts, thymol 5 parts；Or,
Rhizoma Typhonii 50 parts, Pheretima 50 parts, Scolopendra 60 parts, Bombyx Batryticatus 60 parts, Rhizoma Corydalis 30 parts, the Radix Angelicae Dahuricae 30 parts, Radix Angelicae Sinensis 30 parts, Radix Paeoniae Rubra 40 parts, Rhizoma Et Radix Notopterygii 40 parts, 40 parts of Rhizoma Zingiberis Recens, Camphora 10 parts, Borneolum Syntheticum 5 parts, Mentholum 10 parts, thymol 5 parts.
4. the external medicine composition preparation described in any one of claim 1-3, it is characterised in that described dosage form is rubber-emplastrum, cataplasma, ointment or plaster.
5. the preparation method of the external preparation of the Chinese medicine composition described in any one of claim 1-3, comprises the steps:
(1) weigh each raw material components in proportion, pulverize；Taking Rhizoma Typhonii therein, Pheretima, Scolopendra, Bombyx Batryticatus, Rhizoma Corydalis, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Et Radix Notopterygii, Rhizoma Zingiberis Recens mixing, gained mixed powder alcohol solvent extracts, concentration, makes Chinese medicine fluid extract, standby；
(2) taking paste substrate, add Chinese medicine fluid extract and Camphora, Borneolum Syntheticum, Mentholum, the thymol of step (1), glue cream is made in refine；
Preferably, described paste substrate is rubber-emplastrum substrate, ground substance of plaster ointment, ointment base or plaster substrate.
6. the preparation method of the external preparation of Chinese medicine composition as claimed in claim 5, it is characterized in that in step (1) with ethanol being that to carry out extraction be adopt percolation to carry out percolation to solvent, collect percolate, concentrating under reduced pressure, reclaim ethanol, make Chinese medicine fluid extract.
7. the preparation method of the external preparation of the Chinese medicine composition as described in claim 5 or 6, it is characterised in that described alcohol solvent volumetric usage is 1-1.5 times of mixed powder gross mass, volume: quality than unit is ml/g or rise/kilogram；After mixed powder and alcohol solvent being stirred, airtight placement infiltrates 1-3 hour, makes medical material fully expand；Then take the mixed powder after infiltration and load percolator, add alcohol solvent and continue airtight placement dipping 24～48 hours, make the abundant diffusion of solvent, then proceed by percolation.
8. the preparation method of the external preparation of Chinese medicine composition as claimed in claim 7, it is characterised in that when the mixed powder after infiltration loads percolator, mixed powder gradation is uniformly loaded percolator；Open percolator end opening switch, slowly add alcohol solvent, the closing switch when there being liquid to flow out from end opening from top, to get rid of the interstitial air of medicated powder, continuously add alcohol solvent to exceeding mixed powder upper surface 1-10 centimetre.
9. the preparation method of the external preparation of Chinese medicine composition as claimed in claim 7, it is characterized in that, when proceeding by percolation, control percolation speed, effluent per hour is made to be equivalent to the 1/48～1/24 of percolator dischargeable capacity, and alcohol solvent is constantly added from top, keep solvent liquid level higher than mixed powder upper surface；Collect 5～6 times amount that percolate volume is mixed powder gross mass, unit: ml/g, or rise/kilogram.
10. the preparation method of the external preparation of Chinese medicine composition as claimed in claim 7, it is characterised in that in step (1), described thickening temperature is 50～85 DEG C；
The relative density of described Chinese medicine fluid extract is 1.05～1.10, and reference density is water, 50～65 DEG C of surveys；
Described alcohol solvent is the ethanol of volume fraction 70-90；
Described crude drug is ground into coarse powder, whole mistake 24 mesh sieves and wherein can cross 65 mesh sieves less than the 40% of coarse powder gross mass.
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