CN106822326A - New medicine patch cervicodynia emplastrum and preparation method thereof - Google Patents
New medicine patch cervicodynia emplastrum and preparation method thereof Download PDFInfo
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- CN106822326A CN106822326A CN201510887536.4A CN201510887536A CN106822326A CN 106822326 A CN106822326 A CN 106822326A CN 201510887536 A CN201510887536 A CN 201510887536A CN 106822326 A CN106822326 A CN 106822326A
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Classifications
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- A61K36/236—Ligusticum (licorice-root)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract
The invention discloses a kind of cervicodynia patch new medicine patch and preparation method thereof, contained drug ingedient mainly includes Ligusticum wallichii, caulis sinomenii, the root of Chinese clematis, the radix paeoniae rubrathe, corydalis tuber, the ethanol solution extract and camphor, menthol of pericarpium zanthoxyli in the cervicodynia patch;Wherein carrying medicine adhesive each component includes:SIS and styrene-isoprene di-block copolymer, tackifier, softening agent, antioxidant.Cervicodynia of the invention patch has that skin is non-stimulated, stickup without allergy, long-term save medicine good stability and skin is good, it is repeatable paste, meet water it is not inharmonious the features such as.The present invention also provides a kind of novel process for preparing above-mentioned cervicodynia paster, with following features:Medicine heated time is short, only needs 10s-50s, and heating temperature is relatively low, can effectively protect thermal sensitivity drug ingedient therein not to be lost in because volatilizing or being heated oxygen destruction, to effectively improve and do not need organic solvent in the validity and security of medicine, and process.
Description
Technical field
The present invention relates to a kind of cervicodynia patch drug transdermal paster and its pharmaceutical carrier adhesive and its drug transdermal paster
A kind of preparation method, be used to treat a kind of drug transdermal paster of cervical spondylopathy, specific effect has promoting blood circulation and removing obstruction in channels, promoting blood circulation and removing blood stasis,
Dispelling cold and removing dampness, swelling and pain relieving, for cervical spondylopathy(Spondylotic radiculopathy)Hemostasis is stagnated, syndrome of cold-dampness blocking collaterals, symptoms include neck pain, shoulder arm pain
Bitterly, neck activity is unfavorable, the tired effect such as again of extremity numbness, aversion to cold and cold limbs, limbs.
Background technology
Cervical spondylopathy, also known as cervical spine syndrome, is osteoarthritis of cervical spine, proliferative cervical spondylosis, cervical syndrome, cervical vertebra
The general name of Spondylosis disease, is a kind of illness that basis is changed into degeneration pathology.Strained for a long time mainly due to cervical vertebra, sclerotin
Hyperplasia, or Disc herniation, ligament are thickened, and cause cervical vertebra spinal cord, nerve root or vertebral artery to be pressurized, and a series of dysfunctions occur
Clinical syndrome.Show as intervertebral disc degradation in itself and its Secondary cases a series of pathological changes, such as vertebra section unstability, pine
It is dynamic;Nucleus pulposus or abjection;Spur is formed;A series of lesions that plump and secondary spinal canal stenosis of ligament etc. should be sent out.It is one
Common the diseases of middle -and old -aged person is planted, the long-term worker for bending over the desk that bows also is mainly in.With advancing age, cervical intervertebral disk is moved back
Row becomes, so as to influence the stability of cervical vertebra and a series of pathology for producing are sexually revised, these changes directly stimulate, compressing or logical
Crossing influences blood transportation to cause the infringement in nerve root, spinal cord, vertebral artery or sympathetic nerve generating function or the structure of neck, draws
Play corresponding clinical symptoms.Nerve root cervical vertebra sickness is because of cervical intervertebral disk Nucleus pulposus, centrum trailing edge and uncovertebral joint spur shape
The unilateral or bilateral root compression that causes into factors such as, cervical spine instabilies or it is stimulated caused by, show as and nerve root distribution one
The sensation of cause, reflection and dyskinesia.Incidence of disease highest of the nerve root cervical vertebra sickness in all kinds of myelopathies, account for 50%~
60%。
The etiology and pathogenesis of cervical spondylopathy:Traditional Chinese medicine mainly has for the understanding of this sick etiology and pathogenesis:1. the evil invasion and attack of cold-dampness;2. labor
Damage;3. cervical posture is bad;4. wound;5. sphagiasmus.This disease is the card of asthenia in origin and asthenia in superficiality, more by actual situation and miscellaneous combined into disease.
It is caused by liver and kidney deficiency, is designated as the evil invasion and attack of wind, cold, wet and stagnation of blood stasis, at the same strain, wound etc. be also fall ill it is important because
Element.QI invigorating that the rules for the treatment of are soothing the liver, promoting blood circulation and removing blood stasis, dispelling cold and removing dampness, swelling and pain relieving is mainly used in hemostasis stagnation, cold dampness accumulation pattern nerve root
The treatment of cervical spondylopathy.
Treatment of the modern medicine to cervical spondylopathy typically has endo-medicine and non-operative treatment such as to draw, physiotherapy, closing, but
Because cervical spondylopathy pathology is complicated, curative effect is typically undesirable.
Similar cervicodynia pastes this kind of chemical feeding quantity than larger Chinese medicine extract or the Chinese medicine transdermal patch of medicinal extract class at present, typically
All it is that, with natural rubber cream or hydrogel as carrier matrix is prepared from, but this kind of carrier matrix is in security, easy to use
The everyways such as property have problems.
Natural rubber cream is susceptible to allergy, not reproducible stickup, meets inharmonious water, stripping pain, sticks for a long time easily
The problems such as there is " sweat is detained disease ".
The stickup poor performance of hydrogel, it is impossible to stick for a long time, there is also the problem that can not repeat to paste.
Traditional cervicodynia patch preparation technology is typically medicine and is prepared from after being fried under 220-240 DEG C of high temperature, in high temperature
Under cause drug failure serious, such as refer to fry part using high temperature in patent CN1359704A, CN1248454A
Drug ingedient.
The content of the invention
In view of the above problems, the purpose of the present invention is to overcome the deficiencies in the prior art, there is provided a kind of new treatment cervical spondylopathy
Cervicodynia patch, it has functions that remove rheumatism, dredging the channel, the analgesic of promoting blood circulation and removing blood stasis, relaxing muscles and tendons, can directly be externally applied to cervical vertebra ache
Lesion, with good curative effect, and has no toxic side effect.
The invention reside in a kind of novel head pain patch percutaneous plaster is provided, its drug ingedient includes Ligusticum wallichii, caulis sinomenii, Wheeling
The medicinal extract that mixing camphor, menthol are prepared into after the extract solution of celestial being, the radix paeoniae rubrathe, corydalis tuber, pericarpium zanthoxyli etc. is concentrated;It carries medicine matrix
Adhesive with SIS as framework material, the two mixes under certain process conditions
Uniform being attached on backing cloth is prepared from, and it has promoting blood circulation and removing obstruction in channels, promoting blood circulation and removing blood stasis, dispelling cold and removing dampness, swelling and pain relieving, for cervical vertebra
Disease(Spondylotic radiculopathy)Hemostasis stagnate, syndrome of cold-dampness blocking collaterals, symptoms include neck pain, shoulder arm pain, unfavorable neck activity, extremity numbness,
The tired effect such as again of aversion to cold and cold limbs, limbs.It also has sticking performance excellent, non-stimulated without allergy, painless during stripping, can be again
Copy/paste, chemical feeding quantity is big, and sweat delay disease is reduced into sufficiently low level, while using novel preparation process side
Method, can, medicine heated time relatively low in temperature it is extremely short(Between about 10s-60s)Under conditions of be prepared from, low temperature
Degree, farthest protect effective ingredient in the short time, it is to avoid destruction of the high temperature to medicine.
It is an object of the present invention to provide one kind with SIS or/and benzene
Ethene-isoprene di-block copolymer is the adhesive of framework material as host material, outside the Chinese medicine for being used to prepare pastille
With transdermal patch and select with treat the medicine of cervical spondylopathy be model drug be prepared for cervicodynia paste percutaneous plaster.
The present invention has carried out very deep system research to reach the purpose of above-mentioned preparation cervicodynia patch percutaneous plaster, wraps
Include drug extract extraction process, the formula of matrix adhesive, percutaneous plaster moulding process etc. to the release of medicine and transdermal effect,
Active constituent content influence, the influence to medicine stability each side, so as to complete the present invention.
That is, percutaneous plaster is pasted it is an object of the present invention to provide a kind of cervicodynia for treating cervical spondylopathy, the paster is main
By the pressure-sensitive adhesive with adhesive property, after the extract solution of Ligusticum wallichii, caulis sinomenii, the root of Chinese clematis, the radix paeoniae rubrathe, corydalis tuber etc. is concentrated
The medicinal extract that mixing camphor, menthol are prepared into, the backing cloth adhered to adhesive and medicinal mixture and mould release membrance composition.Its
In the above-mentioned adhesive with pressure-sensitive be with SIS and/or styrene-isoamyl
The elastomer of diene di-block copolymer is good for framework material, tackifier, caking property macromolecular material and above-mentioned each component have
The oil of good compatibility is constituted as softening agent, antioxidant, inorganic filler such as calcium carbonate, zinc oxide and talcum powder etc..
It is another object of the present invention to provide a kind of preparation of the Chinese medicine preparation and its drug extract for treating cervical spondylopathy
The drug extract of method, wherein drug ingedient including Ligusticum wallichii, caulis sinomenii, the root of Chinese clematis, the radix paeoniae rubrathe, corydalis tuber, pericarpium zanthoxyli etc., also including camphor tree
Brain and menthol.Specifically the preparation method of Chinese medical concrete is:Above five tastes medicine in addition to camphor, menthol is ground into slightly
Powder, is run through with water, and the ethanol for plus 95% soaks 2 hours, diacolation, collects percolate;Continue to be oozed with 75% ethanol percolation and collection
Filter liquid, merge percolate, be concentrated under reduced pressure into the medicinal extract that relative density is 1.25~1.3, it is standby.
The proportioning of each raw medicinal material for being used to prepare drug extract in cervicodynia patch of the invention is as follows:200~400g of Ligusticum wallichii,
100~300g of caulis sinomenii, 100~300g of pericarpium zanthoxyli, 100~300g of the root of Chinese clematis, 100~300g of the radix paeoniae rubrathe, 50~150g of corydalis tuber, camphor tree
60~100g of brain, 20~50g of menthol.
Ligusticum wallichii in the present invention:Taste is pungent gas fragrance warm in nature, Return liver, courage, pericardium channel.With pungent-warm row dissipate, fragrant Wen Xuantong it
Work(, can rise to dissipate, and can lead to manage it, and walk without keeping, the up head of energy, assign the sea of blood, and outer thorough fur bypasses four limbs, is gas in blood
Medicine.Kind scattered ailment said due to cold or exposure, qi and blood circulation promotion, relieving stagnation, promoting blood circulation, therefore have blood-activating and qi-promoting, wind-expelling pain-stopping effect.It is longer than treatment headache and chill
Shi Paralysis limbs pains.If the diseases such as treatment Feng Shi Paralysis resistances, podomere pain, numbness, can be with notopterygium root, cassia twig, coix seed, Wheeling
The dispelling wind and removing obstruction in the meridians medicine compatibility such as celestial being, bark of ash, caulis piperis futokadsurae.”
Caulis sinomenii in the present invention:Property it is bitter, pungent, put down, Return liver, the spleen channel.With wind-damp dispelling, degrading the channel, diuresis.For rheumatism numbness
Bitterly, arthroncus, benumbs itch.Ligusticum wallichii and caulis sinomenii compatibility, are complemented each other in side, and wind-damp dispelling, degrading the channel, the promoting flow of qi and blood circulation are led to
Paralysis is relieved pain, and is just accord with this product and is cured mainly the cause of disease of disease, the interpretation of the cause, onset and process of an illness, therefore Ligusticum wallichii is monarch drug in a prescription with amounting to the medicine of caulis sinomenii two.
The root of Chinese clematis in the present invention:Taste is pungent saltiness temperature, returns bladder warp.Have pungent scattered temperature lead to salty soft property, therefore can wind-damp dispelling, lead to
Channels and collaterals Er Zhi Paralysis are bitterly.Bitterly, joint stuffiness is apathetic for all Feng Shi Paralysis, no matter upper under, or can be applied inner in table, therefore
It is Feng Shi Paralysis pain key medicines.The heresy for being applied to rheumatism stops up stagnant numb in Paralysis pains caused by passages through which vital energy circulates, the disease such as muscles and bones is ached, often can be alone
The root of Chinese clematis is end, and heat wine is taken after mixing with liquid;Also can compatibility Radix Angelicae Sinensis, osmanthus heart be ball clothes, such as god answers ball.Now many and notopterygium root, windproof, Ligusticum wallichii, ginger
The medicine compatibility application such as Huang.Modern pharmacological research this product has analgesia, antidiuretic activity.
The radix paeoniae rubrathe in the present invention:Bitter, is slightly cold, return liver warp.With clearing heat and cooling blood, blood stasis removing analgesic.For febrile virulent maculae, tell
Blood bleeding from five sense organs or subcutaneous tissue, red eye, swell pain, liver-depressed hypochondrium pain, closed dysmenorrhea, abdominal mass stomachache, injury from falling down, carbuncle swells sore.The radix paeoniae rubrathe can purify the blood point real
Heat, scattered blood stasis are detained.The radix paeoniae rubrathe is invigorated blood circulation, and property dissipates and rushes down, and promoting blood circulation to remove blood stasis analgesic is good at.
Corydalis tuber in the present invention:Taste is pungent, hardship, it is warm in nature.Return liver, the spleen channel.There is promoting blood circulation, promoting the circulation of qi, analgesic.Cure mainly
The all pains of trusted subordinate's waist and knee;Irregular menstruation;Abdominal mass;Metrorrhagia;Postpartum anemic fainting;Lochiorrhagia;Traumatic injury.The above root of Chinese clematis, the radix paeoniae rubrathe, prolong
The combination of Hu Suosan medicines brings out the best in each other, and is altogether ministerial drug.
Camphor in the present invention:Taste is pungent heat, the thoughts of returning home, the spleen channel.Can be dehumidified desinsection, still have warming and odynolysis to act on.With camphor
Steeping in wine, outer painting, controls traumatic injury.Its gas fragrance is pungent strong, and external application is kind to dehumidify, desinsection, antipruritic, and has the work(of swelling and pain relieving.It is interior
What clothes had a class borneol wards off the dirty effect having one's ideas straightened out.This product is applied to skin a refrigerant sense, and have analgesic, antipruritic and faint local anaesthesia and
Antisepsis.There is stimulation to intestines and stomach, largely then produce n and V.Because hot poisonous, can not excessively apply, take orally suitable
It is careful.
Menthol in the present invention, taste is pungent is cool in nature, return lung, Liver Channel.This product is pungent cool frivolous, is good at dispelling wind and heat from the body, head clearing, and
Energy soothing liver-qi stagnation, for headache due to pathogenic wind-heat, dry throat swells and ache and TCM liver depression Breast bilges frowsty about pain.Because of its aromatic refrigerant, can excited maincenter
Nerve, external application can stimulate nerve endings cold receptor and produce local refrigerant sense, and reflexive cause deep tissue blood vessel
Change and play anti-inflammatory, analgesic, itching-relieving action, to virus and pathogenic bacteria have suppression and killing action, moreover it is possible to play rush infiltration
And choleretic effect.Above camphor, the medicine of menthol two, are altogether the transdermal synergy of external preparation, the product of sterilization and anticorrosion, altogether for assistant makes
Medicine.
Pericarpium zanthoxyli in the present invention, taste is pungent is warm in nature, returns spleen, stomach, kidney channel.Warm in pain, desinsection is antipruritic.Its pungent scattered temperate-dryness is long
In middle benefit gas eliminating dampness, eliminating cold to stop pain.
Pharmaceutical carrier adhesive in the present invention is characterised by that its framework material styrene-isoprene-phenylethene is embedding
Section copolymer number-average molecular weight Mn between 70000~250000, preferred number average molecular weight Mn 75000~200000 it
Between, more preferably number-average molecular weight Mn is between 80000~160000, and preferably linear structure, the wherein content of combinated styrene content
It is 10%~30%, is 14%~30% preferably in combination with styrene-content.Select the styrene-isoprene-phenylethene of this structure
Block copolymer has appropriate cohesive force, if its molecular weight Mn is less than 70000 or the content of combinated styrene content is less than
When 10%, the cohesive force of framework material is relatively small, and the pad pasting being prepared into is susceptible to strike-through, excessive glue, the problem using residual,
If molecular weight higher than 250000 and combinated styrene content content be more than 30% when framework material cohesive force it is relatively large, can make
Into pad pasting applicating property it is poor, drug ingedient release performance is poor, percutaneous abilities can further be deteriorated.Benzene second in matrix adhesive
The weight/mass percentage composition of alkene-isoprene-styrene block copolymer between 10%~55%, between preferably 14%~50%, more
Between preferably 17%~42%, between more preferably 20%~34%.Parents' gel material when weight/mass percentage composition is less than 10%
The cohesive force of material becomes excessively poor, it is prepared into pad pasting glue-line be susceptible to the problem of damaged, rotten glue, strike-through, excessive glue, and
Drugloading rate very little;When weight/mass percentage composition is more than 55%, the cohesive force of parents' gel rubber material is excessive, poor processability, processing
Temperature is too high, and heat sensitive drugs nutritional ingredient can be damaged, and can also influence release and the percutaneous abilities of drug ingedient.
Pharmaceutical carrier adhesive in the present invention is characterised by wherein being used for the styrene-different of framework material property regulation
The number-average molecular weight Mn of pentadiene di-block copolymer between 30000~200000, between preferably 50000~140000,
Wherein combinated styrene content content is 10%~30%, is 14%~30% preferably in combination with styrene-content, selects the benzene second of this structure
Alkene-isoprene di-block copolymer is advantageous in that can either preferably adjust framework material styrene-isoprene-benzene second
The processing characteristics of alkene, reduce its softening point, make it that there is with skin good sticking performance, but destruction its cohesion will not be caused
The weight/mass percentage composition of the problem of power, wherein styrene-isoprene block copolymer between 0~50%, preferably 0~35%
Between, between more preferably 0~25%.
The framework material softening agent that pharmaceutical carrier adhesive in the present invention is characterised by selected exists including molecular weight
Between 100~1000 low-molecular-weight polyisobutylene, naphthenic oil, atoleine, soybean oil and its derivative such as epoxidized soybean oil and
One or more in the mineral oil such as oil with hydrogenated soybean, olive oil, apricot kernel oil, grape-kernel oil, wheat-germ oil or vegetable oil,
It is preferred that it is relatively good with framework material SIS and styrene-isoprene compatibility and
And there is between in temperature being 130 DEG C~200 DEG C the grease type of good thermo-oxidative stability, preferred molecular weight is 100~1000
Between low-molecular-weight polyisobutylene, naphthenic oil, atoleine, soybean oil and its derivative such as epoxidized soybean oil and hydrogenated soybean
One or several in oil, more preferably in low-molecular-weight polyisobutylene, atoleine of the molecular weight between 400~1000
One or two kinds of.Weight/mass percentage composition of the softening agent in pharmaceutical carrier adhesive between 12%~55%, preferably 17%~
Between 45%, between more preferably 20%~32%, through our experimental studies, when the weight/mass percentage composition of softening agent is this it
Between when, pharmaceutical carrier adhesive has preferable cohesive force, to framework material styrene-isoprene-phenylethene and styrene-
Isoprene has good solute effect, while prepared adhesive has relatively low softening point, at a lower temperature
There is preferable processing characteristics, low softening point and preferable processing characteristics have in the process of product to drug ingedient
Have protective effect, especially for hot oxygen is unstable or volatile drug ingedient, can substantially reduce its due to high temperature quilt
Oxidation or the volatilization of the degree decomposed or reduction effumability drug ingedient, if the weight/mass percentage composition of softening agent is less than
The solute effect of 12% styrene-isoprene-phenylethene is poor, and dissolution time is greatly increased, and can destroy framework material
Structure, while the softening point of the pharmaceutical carrier adhesive being prepared into is higher, cohesive force is big, poor processability, and high temperature can break
Bad medicine nutritional ingredient, particularly hot oxygen is unstable or effumability medicine nutritional ingredient, is not suitable for adding drug ingedient, while
The release transdermal of drug ingedient can be deteriorated;When the weight/mass percentage composition of softening agent is more than 55%, then its cohesive force is deteriorated, adhesive
Embossability be deteriorated, the problems such as easily there is strike-through, excessive glue, skin and remain.
Pharmaceutical carrier adhesive is characterised by that selected tackifier mainly include rosin resin and its spread out in the present invention
Biological species such as ester gum, hydrogenated rosin etc., C5 Petropols and its derivative, C9 Petropols, terpene resin class, molecule
Amount low-molecular-weight polyisobutylene between 1000~20000, middle-molecular-weihydroxyethyl polyisobutene of the molecular weight between 20,000~50,000, point
High molecular weight polyisobutylene of the son amount between 50,000~200,000, polyurethanes is polyamide-based, epoxy resin, polyacrylic acid
Class, one or more in silicone.It is preferred that rosin resin and its derivative such as ester gum and hydrogenated rosin, C5 oil trees
Fat and its derivative, molecular weight low-molecular-weight polyisobutylene between 1000~20000, during molecular weight is between 20,000~50,000
Molec weight polyisobutylene, high molecular weight polyisobutylene of the molecular weight between 50,000~200,000, polyurethanes, polyacrylic, silicon
One or more in ketone.More preferably rosin resin and its derivative such as ester gum and hydrogenated rosin etc., point
Son amount between 1000~20000 middle-molecular-weihydroxyethyl polyisobutene between 20,000~50,000 of low-molecular-weight polyisobutylene, molecular weight,
One or more in high molecular weight polyisobutylene of the molecular weight between 50,000~200,000, and added tackifier quality hundred
Point content between 10%~60%, between preferably 15%~55%, between more preferably 25%~45%, more preferably 32%
Between~45%.If the content of tackifier is less than the 10% of adhesive gross mass, it is impossible to enough that effective stickup performance is provided, no
The need for meeting as drug transdermal patch, when the content of tackifier is higher than 60%, its peeling force is excessive, skin during stripping
There are serious pain, heavy damage epidermal structure, while having the cohesive force of adhesive compared with havoc, have influence on it and carry medicine
Amount, there is excessive glue phenomenon around paster when using, skin surface residual is serious.
Pharmaceutical carrier adhesive in the present invention is characterised by wherein including antioxidant, is used to prevent skeleton material
Material is oxidized destruction, and then influences the drugloading rate of adhesive, cohesive force, stripping performance, skin to stick effect, it is also possible to influence
To the shelf-life of medicine, trigger the quality problems of medicine, wherein antioxidant includes BHT264, antioxidant 1010 etc., pharmaceutical carrier
Weight/mass percentage composition shared by antioxidant in adhesive is between the 0.01%~2.5% of contained framework material gross mass, preferably
Between 0.1%~2%, between more preferably 0.4%~1.2%.
Pharmaceutical carrier adhesive is characterised by it is also an option that addition water-soluble high-molecular material or hydrophilic in the present invention
Property material further improves itself and the sticking performance of skin and the affine performance of medicine, particularly with mostly alcohol extracting or water extraction
Chinese herbal medicine extract between affine performance, this can improve this kind of medicine scattered stability in carrier adhesive, really
Curative effect of medication is protected, security is improved, and is effective to extending the shelf-life of medicine.This kind of hydroaropic substance includes compound
Monomer, oligomer, high polymer.Can be from the point of view of from source synthesis, or natural extraction as various animals and plants carry
Take thing etc..Specifically there are propane diols, glycerine, polyacrylate and its esters, hyaluronic acid and its esters, cellulose family, starch
Class, poly-aspartic-acid, algin class such as sodium alginate etc., Aloe Vera Gel, polyvinyl alcohol, hydrolyzed polyacrylamide, polyethylene pyrrole
The water-soluble macromolecules such as pyrrolidone, other natural plant gum, animal glue, also including cross linked polyacrylate and its esters, acrylic acid
With one or more in the absorptive substance such as the copolymer of starch, vinyl alcohol etc..The above water-soluble high-molecular material and
Weight/mass percentage composition of the hydroaropic substance in carrier adhesive between 0~10%, between preferably 0.5~5%.
Pharmaceutical carrier adhesive in the present invention be characterised by wherein can also include other have improve its embossability,
The special auxiliary agent of the function demands such as cohesive force, the medicine dispersion effect such as filler such as calcium carbonate, titanium dioxide, zinc oxide, talcum powder, its
Weight/mass percentage composition in adhesive between 0~10%, between preferably 1%~6%.
In the present invention cervicodynia patch be characterised by drug ingedient therein account for glue medicine mixture gross mass 5%~30% it
Between, between preferably 8%~25%.
Cervicodynia patch is characterised by that its coating is prepared into backing cloth used during pad pasting and includes non-woven fabrics, weaving in the present invention
Cloth, bidirectional elastic cloth and unidirectional stretch fabric, polyurethanes film etc., the thickness of selected backing cloth are excellent between 5 μm~1500 μm
Elect as between 100 μm~1000 μm, the backing cloth in thickness range is selected more than, the premise of preferable support force can be provided
It is lower to seem " thick and heavy " again, and the effect for preferably being sticked with skin can be provided.
In the present invention cervicodynia patch be characterised by its coating be prepared into release membrane material used during pad pasting including PET, PE,
The mould release membrance and release liners of the non-papery class such as PP, PU, PC, these mould release membrances or release liners can be one side it is release can also be
It is two-sided release, the thickness of mould release membrance used between 0.01mm~0.5mm, between preferably 0.03mm~0.3mm.Selection is thick
Spend interval mould release membrance more than has preferable advantage in the realization of product preparation process, while can also provide enough branch
Support force.
The present invention also aims to provide a kind of method of the cervicodynia patch prepared in the present invention, this preparation medicine patch
Method have medicine heated time short, it is only necessary to 10s~60s, medicine heating temperature is relatively low, below 120 DEG C,
This low temperature and the short process conditions of medicine heated time have very to the drug ingedient of effumability therein and thermal sensitivity
Good protective effect, can to greatest extent avoid these compositions from being destroyed, and improve the validity and safety in utilization of medicine, tool
Body technology flow is as follows:
1)The various components that will prepare adhesive according to certain ratio mix, and according to the order of addition general of each raw material for determining
The various components prepared used by adhesive are added in the reactor with agitator, in certain temperature, certain mixing speed
Under be completely dissolved and be well mixed to framework material, it is standby;
2)Camphor, menthol are added to the medicinal extract extraction of Ligusticum wallichii, caulis sinomenii, the root of Chinese clematis, the radix paeoniae rubrathe, corydalis tuber according to the amount for determining
It is well mixed and make camphor, menthol dissolving complete in liquid, it is standby;
3)By 1)In the adhesive for preparing be added in the glue melting box with precision metering pump and set glue melting box to certain
Temperature constant state;By 2)In the drug extract for preparing be added in the explosive box with precision metering pump and agitating paddle and according to one
Fixed requirement stirring liquid;
4)Coating machine is opened, during drug extract and glue accurately pumped into screw machine respectively through glue pump and Teat pipette, in a constant temperature
Glue and drug extract are quickly well mixed under degree;
5)The glue medicine mixture that will be mixed uniformly is applied on backing cloth and covers mould release membrance, and is die-cut to the paster of certain specification
.
Specific embodiment
Some embodiments of the present invention are described below, to be further understood that the present invention.
Embodiment 1
This experiment with SIS that combinated styrene content content is 15% as framework material,
Atoleine is softening agent, and hydrogenated rosin glyceride is prepared for Chinese medicine transdermal patch pharmaceutical carrier adhesive for tackifier, tool
Body is as follows:
Gluing agent prescription used:
Ingredient names | Styrene and isoprene block copolymer | Hydrogenated rosin glyceride | Atoleine | Antioxidant | Other function additives |
Content Wt/% | 31 | 33 | 29 | 0.2 | 6.8 |
With SIS " for framework material prepares medical transdermal patch adhesive, add
Plus tackifier, softening agent, antioxidant, other specific function auxiliary agents such as inorganic filler, hydroaropic substance etc..Specific auxiliary agent raw material is such as
Under:
Tackifier:In the present embodiment tackifier used can also be it is following in use cooperatively for one or more, including:Rosin tree
Lipid, hydrogenated rosin resin class, C5Petropols class, hydrogenation C5Petropols class, terpene resin class, C9Resinae, C5—C9Tree
Lipid, polyisobutene, middle-molecular-weihydroxyethyl polyisobutene, low-molecular-weight polyisobutylene of HMW etc..
Softening agent:In the present embodiment softening agent used can be it is following in use cooperatively for one or more, including:Liquid
Body paraffin class, cycloalkanes oils, hydrogenated soybean oils, epoxy soybean oils, low-molecular-weight polyisobutylene, other suitable mineral oil
Class.
Other function additives have:The inorganic fillers such as calcium carbonate, talcum powder, zinc oxide, hydrophilic macromolecule, water imbibition thing
Matter, amphiphilic macromolecular, the surfactant of small molecule, inorganic filler, specific function auxiliary agent are as improving certain performance
Nanometer materials, synthetic rubber class etc..Other function additives are used cooperatively comprising one or more following materials:It is hydrophilic
Property macromolecule, absorptive substance, amphiphilic macromolecular, the surfactant of small molecule, inorganic filler, specific function auxiliary agent as use
In nanometer materials, synthetic rubber class for improving certain performance etc., such as 1)Water-soluble macromolecule:It is with natural animal-plant
Raw material is extracted and obtained:Such as starch, cellulose, natural plant gum, animal glue;2)Naturally(Or chemical modification)Polymer:Mainly have
Biogum such as algin etc., modified starch and modified cellulose, such as algin, Aloe Vera Gel, chitin, CMS, acetic acid
Starch, hydroxymethyl cellulose, carboxymethylcellulose calcium, cyclodextrin etc.; 3)Synthetic polymer:There are polymer resin and condensation class tree
The class of fat two, such as polyacrylamide (PAM), hydrolyzed polyacrylamide (HPAM)), polyvinylpyrrolidone (PVP), methacrylic acid
Beta-hydroxy ethyl ester (HEMA), long-chain aliphatic acrylate (RA), super absorbent resin(Such as crosslinked salt polyacrylate class, starch-poly-
Acrylate copolymer, acrylic acid-ethenol copolymer, polyoxyethylene crosslinked, cross-linked isobutylene-maleate copolymer
System etc.)Deng;
The specific preparation method of adhesive is as described below:
1)To adding SIS in reactor, and stirring is opened simultaneously;
2)By auxiliary agent powder(Antioxidant etc.)Add in atoleine, added after homogeneous in a reservoir in reactor, continue to stir;
3)Continuously add hydrogenated rosin glyceride Petropols;
4)After charging is finished, the temperature for setting oil bath pan is 160 DEG C, starts clock reaction 3.5h, rear plastic emitting, you can.
Embodiment 2
This experiment is with SIS that combinated styrene content content is 15% and styrene-different
Pentadiene di-block copolymer is framework material, molecular weight be 400 low-molecular-weight polyisobutylene for softening agent, hydrogenated rosin is sweet
The polyisobutene of grease and different molecular weight is prepared for cervicodynia patch pharmaceutical carrier adhesive for tackifier, specific as follows:
Gluing agent prescription used:
Ingredient names | SIS and styrene-isoprene di-block copolymer | Hydrogenated rosin glyceride | Middle-molecular-weihydroxyethyl polyisobutene | Polyisobutene Mn=400 | Antioxidant | Other function additives |
Content Wt/% | 36 | 21 | 10 | 28 | 0.1 | 4.9 |
With SIS and styrene-isoprene di-block copolymer as framework material
Prepare medical transdermal patch adhesive, addition tackifier, softening agent, antioxidant, inorganic filler, other specific function auxiliary agents
Deng.Specific auxiliary agent raw material is as described in example 1 above:
The specific preparation method of adhesive is as described below:
1)To adding SIS in reactor, and stirring is opened simultaneously;
2)By auxiliary agent powder(Antioxidant etc.)Add in the polyisobutene of molecular weight Mn=400, add reaction after homogeneous in a reservoir
In kettle, continue to stir;
3)Continuously add hydrogenated rosin glyceride Petropols and middle-molecular-weihydroxyethyl polyisobutene;
4)After charging is finished, the temperature for setting oil bath pan is 160 DEG C, starts clock reaction 3.5h, rear plastic emitting, you can.
Embodiment 3
This experiment is prepared for the cervicodynia patch drug extract for the purpose for the treatment of cervical spondylopathy, and specific composition and its preparation technology are as follows:
The drug prescription of cervicodynia patch includes:Ligusticum wallichii 330g, caulis sinomenii 250g, root of Chinese clematis 280g, radix paeoniae rubrathe 200g, corydalis tuber 120g,
Pericarpium zanthoxyli 250g, camphor 80g, menthol 35g totally 8 herbal medicine.
Medicinal extract preparation technology:Above six medicaments will be ground into meal in addition to camphor, menthol, be run through with water, plus 95%
Ethanol immersion certain hour, diacolation, collect percolate;Continue, with 75% ethanol percolation, to collect percolate, merge percolate,
The medicinal extract that relative density is 1.25-1.3 is concentrated under reduced pressure into, it is standby.
Embodiment 4
This experiment is prepared for cervicodynia patch percutaneous plaster using for preparing the new-type heat-melting method preparation technology of externally applied transdermal paster, this
Kind new transdermal patch preparation technology has medicine heated time extremely short, is between 30 seconds~60 seconds, homogeneous is quick, processing temperature
The characteristics of spending low, can effectively protect drug ingedient, it is ensured that product quality.Pharmaceutical carrier adhesive used is preparation in embodiment 1
Gained, specific preparation technology is as follows:
1)The adhesive prepared in embodiment 1 is added in the glue melting box with precision metering pump, melt adhesive temperature as 115 is set
DEG C, it is standby after adhesive melts completely;
2)By camphor, menthol is added in the drug extract extracted in embodiment 3 according to the amount for determining makes camphor, menthol molten
Solution is complete and is well mixed, and is added in the explosive box with precision metering pump and agitating paddle and stirs medicine according to certain requirement
Liquid, it is standby;
3)Coating machine is opened, during drug extract and glue accurately pumped into screw machine respectively through glue pump and Teat pipette, in a constant temperature
Glue and drug extract are quickly well mixed under degree, incorporation time is 40s;
4)The glue medicine mixture that will be mixed uniformly is applied on backing cloth according to the standard of 180g/ ㎡ and covers mould release membrance, and mould
It is cut into the paster of certain specification.
Embodiment 5
This experiment is prepared for cervicodynia patch percutaneous plaster, traditional hot melt transdermal patch using traditional transdermal patch preparation technology
The drawbacks of preparation technology is that medicine is heated at least in 3h, and processing temperature is of a relatively high, and it is right that medicine is heated for a long time at high temperature
The drug ingedient destruction of heat-sensitive ingredients therein and effumability is serious, and then has influence on release and the transdermal effect of medicine,
Affect the treatment, this be also currently marketed treatment cervical spondylopathy external use plaster curative effect it is bad the reason for one of.Meanwhile, traditional heat
The heated time of adhesive is also lengthened in molten method preparation technology, causes adhesive to aoxidize in itself, influences its cohesive force, occurs to overflow
The phenomenons such as glue, strike-through.This experiment using traditional hot melt preparation technology be prepared for cervicodynia paste, be used to comparing it is therein effectively into
Point and effumability composition content, carry out influence of the reacting processing temperature and time to medicine patch quality.Medicine wherein used
Carrier adhesive is preparation gained in embodiment 1, specific as follows:
1)The adhesive prepared in embodiment 1 is added in the reactor with agitating paddle, and sets melt adhesive temperature as 125 DEG C
Melted completely to adhesive, it is standby;
2)The drug extract prepared in embodiment 3 and menthol, camphor are added to 1 according to the ratio for determining)In reactor
In, 2h is persistently stirred in the case where 125 DEG C of constant temperature is kept well mixed to glue medicine;
3)Coating machine is opened, well mixed glue medicine mixture is uniformly applied to through precision metering pump according to the standard of 180g/ ㎡
On backing cloth and mould release membrance is covered, and be die-cut to the paster of certain specification.
Embodiment 6
In prepared by traditional externally applied transdermal paster, generally also use a kind of solvent method preparation technology, this preparation technology be by
After the dissolving of the organic solvents such as adhesive gasoline, ethyl acetate, add drug ingedient to be well mixed, then be coated, then will
Coated coiled material dries a kind of method for obtaining finished product in high temperature drying tunnel, generally the temperature of drying tunnel 110 DEG C~
Between 120 DEG C, a length of 20m of drying tunnel or so, medicine heated time is 5min or so, although this moulding process causes receiving for medicine
The hot time is shorter than traditional hot melt, but because it is heated in the case where non-fully closing, while coated product
Because its glue medicine layer is very thin, it is easier to make effumability composition and thermal instability component damages, and volatilization is organic molten
Agent can not be reclaimed, and to the seriously polluted of environment, be existed because the organic solvents such as gasoline are inflammable and explosive, in production process serious
Potential safety hazard.Its concrete technology is as follows:
1)The adhesive prepared in embodiment 1 is added in the reactor with agitating paddle, and is added according to the ratio for determining
Ethyl acetate, opens stirring until adhesive is completely dissolved;
2)The drug extract and menthol, camphor that are prepared in embodiment 3 are added to 1 according to determination ratio)In, stir;
3)By 2)In the glue medicine mixture for preparing uniformly be applied on backing cloth according to the standard of 180g/ ㎡;
4)By 115 DEG C of high temperature drying tunnels by 3)In organic solvent drying in coated semi-finished product, mould release membrance in covering;
5)Cut into slices according to certain specification, packaging.
Embodiment 7
This experiment is to cervicodynia patch transdermal patch obtained in the Different Preparation employed in embodiment 4, embodiment 5 and embodiment 6
The content of effumability composition camphor and borneol in piece detected, compares new transdermal patch preparation technology and traditional
Influence of the transdermal patch preparation technology to effumability or the content of active component of thermally labile type, it is specific as follows:
Wherein product specification is:Paste containing amount --- 1.25g/ is pasted, and patch specification is 7cm × 10cm.
Drawn by above experimental result, with the medicine in the cervicodynia paster in the present invention prepared by new-type heat-melting method moulding process
Thing effumability composition, the content of heat-sensitive ingredients are higher than and prepare cervicodynia paster with traditional solvent and conventional hot melt method.Say
It is bright preferably to protect effumability composition therein, thermal sensitivity in patch forming process with new-type heat-melting method moulding process
Composition, while can also effectively protect adhesive to prevent it to be excessively oxidated influence, it pastes performance.
Embodiment 8
Embodiment 4 is have selected in this experiment(Sample 1- new-type heat-melting method moulding process), embodiment 5(Sample 2- conventional hot melt methods
Moulding process), embodiment 6(Sample 3- traditional solvent moulding process)Cervicodynia exchange premium row prepared by middle different moulding process
45 person-portions(Three groups are equally divided into, every group of 15 person-portions are tested)Clinic examination patch Contrast on effect, concrete outcome is as follows:
Cervicodynia prepared by table, Different Preparation pastes the contrast of 20 person-portion clinical therapeutic efficacies
As can be seen from the above results, the cervicodynia patch percutaneous plaster prepared with new-type heat-melting method moulding process in the present invention has
Relieve the pain therapeutic action well, all has the obvious effect of relieving the pain, the cervicodynia in using 3 present invention for general pain
After patch percutaneous plaster, the effective percentage to pain therapy has reached 86.7%.Be can also be seen that into by above clinical observation result
The stability and availability influence of the drug ingedient that type technique is pasted to cervicodynia are larger, molten with conventional hot melt method moulding process and tradition
Cervicodynia paster prepared by agent method moulding process, it uses the effective percentage after 3 times to pain therapy to be respectively 6.7% and 40%.
Embodiment 9
This experiment has carried out the test of related stickup performance to cervicodynia patch percutaneous plaster prepared in embodiment 4, mainly includes
Initial bonding strength, holding power, the aspect of peel strength three, it is specific as follows:
Initial bonding strength/steel ball number | Holding power/min | Peel strength/(N/mm) |
22 | 793 | 0.47 |
From the point of view of test data of experiment result, the cervicodynia patch in the present invention has preferably pastes performance and stripping performance.
Embodiment 10
This experiment cuts into the paster that specification is 7cm × 10cm and has carried out human body stickup to cervicodynia patch prepared in embodiment 4
Performance test, specific method of testing and result are as follows:
Table, cervicodynia patch human body adhesiveness and pain test result when peeling off
Drawn by above experimental result, the cervicodynia paster in the present invention has preferable affine performance and stickup property with human body skin
Can, peel strength is moderate, will not cause stronger pain, and also without allergic stimulated phenomenon, its combination property is preferable.With compared with
Relatively preferably, there is not excessive glue yet in good adhesive property, cohesive force, does not occur residual after use, repeats stickup property and can reach
More than five times, comfort is relatively preferable.
Embodiment 11
Heat resistance is tested:Cervicodynia 2, the sample of patch prepared in Example 4(Specification is 7cm × 10cm), mould release membrance is removed,
60 DEG C are heated 2 hours, and after letting cool naturally, without permeability phenomenon, sense that cream face is glossy touches still toughness, still with finger at the back side high
Repeatability is noticed more than 5 times.Meet《Chinese Pharmacopoeia》To the quality requirement of rubber ointment.
Embodiment 12
Plastic property is tested:Cervicodynia 2, the sample of patch prepared in Example 4(Specification is 7cm × 10cm), 37 DEG C, it is relatively wet
30min is placed in the climatic chamber of degree 64%, is taken out, sample is fixed on a smooth steel plate, the inclination angle of steel plate and horizontal plane
It is 60 DEG C, places 24 hours, cream face is without trickling phenomenon.Meet《Chinese Pharmacopoeia》To the quality requirement of rubber ointment.
Embodiment 13
The security of the cervicodynia patch in the present invention has been investigated in this experiment, and used test sample is according to matching somebody with somebody in embodiment 4 in experiment
Side is prepared for cervicodynia patch, has carried out the skin irritation test of rabbit and cavy, specific as follows in experiment:
Experimental animal:Rabbit, 1.8 ~ 2.0kg, cavy, 250 ~ 300g selects male and female half and half.
Animal feeding requirement:Animal House room temperature should be controlled at 22 ± 2 DEG C, and humidity 55% or so, ammonia density is less than 20ppm,
Using 12h:12h occulting lights shine, timing ventilation.All animals are fed with full nutrition feed, every independent label of animal, raise
In in Rotating Stainless Steel Cage, animal ad lib is drunk water.
Rabbit intact skin and damaged skin single skin irritatin:Healthy rabbits, are divided into normal skin group and damaged skin
Group is each 4, using consubstantiality left and right sides self-contrast method, male and female half and half.24h carries out depilation treatment to administration area before experiment, left
Each one piece, the unhairing scope 3cm × 3cm in the right side.Damaged skin group draws " well " word in agents area, to ooze out blood as degree.Every group of left side
The ketoprofen transdermal paster prepared in this present invention is sticked at depilation, right side is fixed as control with gauze, is removed after 24 hours
Ketoprofen transdermal paster.Examine skin at coating whether there is erythema, oedema respectively at 1h, 24h, 72h, by new drug toxicity technology
The requirement of specification carries out skin irritation evaluation.
Skin irritation is evaluated:
(1)Standards of grading:Erythema:Without 0 point of erythema;Slight erythema(It is visible reluctantly)1 point;Moderate erythema(It is clearly visible)2 points;Weight
3 points of erythema of degree;Aubergine erythema forms 4 points to slight eschar.Oedema:Without 0 point of oedema;Mild edema(It is visible reluctantly)1 point;In
Degree oedema(Substantially swell)2 points;Severe edema(Cutaneous protuberance 1mm, profile understands)3 points;Severe edema(Cutaneous protuberance >
1mm simultaneously has expansion)4 points.8 points of highest point total value.
(2)Skin irritatin intensity evaluation standard:0~0.49 point nonirritant;0.50~2.99 point of slight stimulation;3.00
~5.99 points of moderate excitants;6.00~8.00 points of strong and stimulatings.
Administration terminates rear check plot and the tested area's comparative observation of cervicodynia paster, in recipient site without erythema, dry skin, de-
The IRs such as bits, skin wound repair intensity is equal<0.5 point;
Illustrated by above experimental result, the cervicodynia patch in the present invention can be substantially prevented from the drawbacks of causing skin irritatin generation.
Embodiment 14
Different backing cloth are have selected in this experiment, the experiment of skin applicating property has been carried out, different backing cloth has been investigated to transdermal patch
The influence of the stickup performance of agent, sample used is prepared according to the formula in embodiment 4 in experiment, and have selected grammes per square metre for 50g/
The non-woven fabrics of ㎡, the common weaving cloth without elastic force, unidirectional elastic force weaving cloth, bidirectional elastic weaving cloth are compared, and are had
Body experimental result is as follows:
Table, different backing cloth paste the influence of performance to human body
Backing cloth species | Shoulder back examination patch result | Joint examination patch result | Peel off pain |
The non-woven fabrics of 50g/ ㎡ | Edge is easy to inharmonious | It is overall easily to come off | Peel off pain stronger |
Common inelastic weaving cloth | Patch edges are easy to inharmonious | It is overall easily to come off | Peel off pain stronger |
Unidirectional elastic force weaving cloth | The inharmonious phenomenon of patch edges makes moderate progress | Patch portion comes off | Peel off pain lighter |
Bidirectional elastic weaving cloth | There is not the inharmonious phenomenon of patch edges, the coating performance with skin is excellent | Do not occur coming off and inharmonious phenomenon | Without stripping pain |
As can be seen from the above test results, backing cloth has a significant impact to paster with the effect that sticks of skin, and peel off pain
Pain also has relation with backing cloth, and this is probably because different backing cloth should at the edge during sticking and in stripping process
Power difference causes.In general, selection bidirectional elastic weaving cloth is optimal, and unidirectional elastic force weaving cloth takes second place, common inelastic spinning
Combination property of weaving cotton cloth is general, and non-woven fabrics is worst.
The above is the embodiment for embodying research process of the present invention and result, it is noted that for the art
For those of ordinary skill, on the premise of principle of the present invention is not departed from, some improvements and modifications can also be made, these
Improvements and modifications also should be regarded as protection scope of the present invention.
Claims (18)
1. a kind of cervicodynia paster, it is made up of adhesive and drug ingedient, and wherein drug ingedient includes Ligusticum wallichii, caulis sinomenii, Wheeling
The ethanol solution extract of celestial being, the radix paeoniae rubrathe, corydalis tuber and pericarpium zanthoxyli, camphor, menthol and auxiliary component are made;Wherein in adhesive
Contain the skeleton being made up of SIS and styrene-isoprene di-block copolymer
Material;Both weight/mass percentage compositions are accounted between the 10%~55% of adhesive summation, and the weight/mass percentage composition of tackifier accounts for gluing
Between the 10%~60% of agent summation, the weight/mass percentage composition of softening agent is accounted between the 12%~55% of adhesive summation, antioxidant
Weight/mass percentage composition is between the 0.01%~2.5% of framework material gross mass, the inorganic salts of plastic property to be changed as filler
Weight/mass percentage composition is accounted between the 0~10% of adhesive summation, and the wherein total content of medicine is to account for adhesive and medicinal mixture is total
Between the 4%~30% of quality;Be attached on backing cloth after preferred above-mentioned adhesive and medicine are well mixed and covered from
Type paper, wherein adhesive and medicinal mixture layer content are 70 g/ ㎡~230g/ ㎡.
2. cervicodynia according to claim 1 pastes percutaneous plaster, wherein the consumption of each medicinal material needed for preparing medicine is Ligusticum wallichii
200~400 weight portions, the weight portion of caulis sinomenii 100~300, the weight portion of pericarpium zanthoxyli 100~300, the weight portion of the root of Chinese clematis 100~300,
The weight portion of the radix paeoniae rubrathe 100~300, the weight portion of corydalis tuber 50~150, the weight portion of camphor 60~100, the weight portion of menthol 20~50 it
Between.
3. cervicodynia patch percutaneous plaster according to claims 1 to 2, wherein styrene-isoprene-phenylethene block copolymerization
The number-average molecular weight Mn of thing is between 70000~250000, and preferred number average molecular weight Mn is more excellent between 75000~200000
Number-average molecular weight Mn is selected between 80000~160000.
4. cervicodynia patch percutaneous plaster according to claims 1 to 3, the styrene-isoprene-benzene second wherein in adhesive
Alkene block copolymer, it is characterised in that number-average molecular weight Mn 80000~90000,90000~100000,100000~
110000th, 110000~120000,120000~130000,130000~140000,140000~150000,150000~
160000。
5. cervicodynia patch percutaneous plaster according to claims 1 to 4, wherein styrene-isoprene di-block copolymer
Between 30000~200000, between 40000~180000, more preferably number is equal for preferred number average molecular weight for number-average molecular weight Mn
Molecular weight is between 50000~140000.
6. cervicodynia according to claims 1 to 5 pastes percutaneous plaster, and the styrene-isoprene-phenylethene in its adhesive is embedding
Section copolymer and styrene-isoprene block copolymer in, combinated styrene content content be 10%~30%, preferably in combination with styrene
Content is 14%~30%.
7. cervicodynia according to claims 1 to 6 pastes percutaneous plaster, wherein SIS
And the combinated styrene content content of styrene-isoprene block copolymer be 14%~15%, 15%~16%, 16%~17%, 17%~
18%th, 18%~19%, 19%~20%, 20%~21%, 21%~22%, 22%~23%, 26%~27%, 27%~28%, 28%~29%,
Between 29%~30%.
8. cervicodynia patch percutaneous plaster according to claims 1 to 7, styrene-isoprene-phenylethene is embedding in its adhesive
Section copolymer and the preferred linear structure of styrene-isoprene block copolymer.
9. cervicodynia patch percutaneous plaster according to claims 1 to 8, wherein styrene-isoprene-phenylethene block copolymerization
The weight/mass percentage composition summation of thing and styrene-isoprene di-block copolymer between 10%~55%, preferably 14%~
Between 50%, between more preferably 17%~42%, between more preferably 20%~34%.
10. cervicodynia patch percutaneous plaster according to claims 1 to 9, wherein styrene-isoprene-phenylethene block is total to
The weight/mass percentage composition summation of polymers and styrene-isoprene di-block copolymer 20%~22%, 22%~24%, 24%~
26%th, between 26%~28%, 28%~30%, 30%~32%, 32%~34%.
11. cervicodynia patch percutaneous plasters according to claims 1 to 10, wherein tackifier used are selected from the poly- isobutyl of low-molecular-weight
Alkene, middle-molecular-weihydroxyethyl polyisobutene, high molecular weight polyisobutylene, rosin, hydrogenated rosin class, rosin esters, C5 Petropols, C9
In the modified resin of Petropols, terpene resin, epoxy resin, polyamide-based, polyurethanes and above species tackifier one
Plant or several, preferably ester gum, hydrogenated rosin glyceride, low-molecular-weight polyisobutylene, middle-molecular-weihydroxyethyl polyisobutene, height
One or more in molec weight polyisobutylene, wherein tackifier account for the weight/mass percentage composition of adhesive between 10%~60%,
Between preferably 15%~55%, between more preferably 25%~45%, between more preferably 32%~45%.
The 12. cervicodynia patch percutaneous plaster according to claim 1~11, the molecular weight of wherein high molecular weight polyisobutylene exists
Between 50000~200000, molecular weight preferred scope be 50000~170000 between, more preferably 50000~120000 it
Between, the weight/mass percentage composition of the high molecular weight polyisobutylene is between 0~11%;The molecular weight of middle-molecular-weihydroxyethyl polyisobutene exists
Between 20000~50000, the weight/mass percentage composition of the middle-molecular-weihydroxyethyl polyisobutene is between 0~15%;Low-molecular-weight it is poly- different
Between 1000~20000, the weight/mass percentage composition of the low-molecular-weight polyisobutylene is between 0~8% for the molecular weight of butylene.
13. according to the cervicodynia described in claim 1~12 with pasting percutaneous plaster, wherein softening agent used includes molecular weight in 100-
The polyisobutene of the low-molecular-weight between 1000, naphthenic oil, atoleine, olive oil, soybean oil, epoxidized soybean oil, hydrogenation are big
One or several in soya-bean oil, preferably the low-molecular-weight of naphthenic oil, atoleine, molecular weight between 400-1000 is poly- different
One or more in butylene, more preferably atoleine, the wherein weight/mass percentage composition of softening agent 12%~55% it
Between, between preferably 17%~45%, more preferably 20%~32%.
The 14. cervicodynia patch percutaneous plaster according to claim 1~13, wherein antioxidant used includes BHT264, antioxygen
Agent 1010 etc., weight/mass percentage composition shared by the antioxidant in pharmaceutical carrier adhesive is the 0.01% of contained framework material gross mass
Between~2.5%, between preferably 0.1%~2%, between more preferably 0.4%~1.2%.
In the 15. cervicodynia patch percutaneous plaster according to claim 1~14, drug ingedient therein accounts for the glue total matter of medicine mixture
Between the 4%~30% of amount, between preferably 8%~25%.
16. cervicodynia paste percutaneous plaster, the adhesive described in any one of the claims 1~15 wherein accompanying on backing cloth
And the glue medicine mixed layer that the mixture of medicine is formed, its glue medicine mixture layer content is 70 g/ ㎡~230g/ ㎡, preferably 120
G/ ㎡~200g/ ㎡, more preferably 150 g/ ㎡~170g/ ㎡.
The preparation method of the cervicodynia patch described in 17. claim 1-16 any one, it is described in detail below:
1)The adhesive that will be prepared is added in the glue melting box with precision metering pump, sets appropriate melt adhesive temperature, treats glue
Glutinous agent is completely dissolved rear standby;
2)Camphor, menthol are added to and make camphor, peppermint in the drug extract extracted in claim 1 according to the amount for determining
Brain dissolving is complete and is well mixed, and is added in the explosive box with precision metering pump and agitating paddle and is stirred according to certain requirement
Liquid is mixed, it is standby;
3)Coating machine is opened, during drug extract and glue accurately pumped into screw machine respectively through glue pump and Teat pipette, in a constant temperature
Glue and drug extract are quickly well mixed under degree, incorporation time is between 20s~80s;
4)The glue medicine mixture that will be mixed uniformly is applied on backing cloth according to the standard of 180g/ ㎡ and covers mould release membrance, and mould
It is cut into the paster of certain specification.
18. a kind of cervicodynia patches, it is characterised in that the consumption for preparing each medicinal material of active component is the weight portion of Ligusticum wallichii 200~400, green grass or young crops
The weight portion of wind rattan 100~300, the weight portion of pericarpium zanthoxyli 100~300, the weight portion of the root of Chinese clematis 100~300, the weight of the radix paeoniae rubrathe 100~300
Part, between the weight portion of corydalis tuber 50~150, the weight portion of camphor 60~100, the weight portion of menthol 20~50.
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