CN105998649A - Compound traditional Chinese medicine micro needle transdermal patch for treating scapulohumeral periarthritis and preparation method - Google Patents
Compound traditional Chinese medicine micro needle transdermal patch for treating scapulohumeral periarthritis and preparation method Download PDFInfo
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- CN105998649A CN105998649A CN201610478620.5A CN201610478620A CN105998649A CN 105998649 A CN105998649 A CN 105998649A CN 201610478620 A CN201610478620 A CN 201610478620A CN 105998649 A CN105998649 A CN 105998649A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8969—Polygonatum (Solomon's seal)
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- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
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- A61K9/51—Nanocapsules; Nanoparticles
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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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
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract
The invention discloses a compound traditional Chinese medicine micro needle transdermal patch for treating scapulohumeral periarthritis and a preparation method. The compound traditional Chinese medicine micro needle transdermal patch is prepared from medical materials including poria, manyflower solomonseal rhizomes, cortex eucommiae, cortex cinnamomi, herba schizonepetae, rhizoma chuanxiong, roots or stems of smoothfruit ventilago, Japanese creeper, leaves or roots of dentate wampee, silvery aleuritopteris and radix angelicae pubescentis and auxiliaries including polysorbate-80, granulesten, glycerin monostearate and tacrolimus. The patch is composed of a base plate, medicament, an ointment blank patch body and an ointment back patch body, the front face of the base plate is provided with a plurality of micro needles, micro needle gaps are formed among the micro needles, the medicament is stored in the micro needle gaps and a porous structure of the base plate, the back face of the base plate is pasted to the inner surface of the ointment blank patch body, the inner surface of the ointment back patch body is arranged on the front face of the base plate in a covering mode, and the inner surface of the ointment blank patch body and the inner surface of the ointment back patch body are fixedly connected in a pasting mode. The invention further discloses preparation steps of the micro needle transdermal patch. The micro needle transdermal patch has the advantages of being precise in medicine composition, free of pain, capable of being released slowly, efficient and convenient to apply.
Description
Technical field
The present invention relates to tcm field, particularly relate to a kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture and preparation method.
Background technology
Scapulohumeral periarthritis is the chronic aseptic inflammation of the soft tissues such as shoulder joint Surrounding muscles, tendon, synovial bursa and joint capsule.Inflammation causes
The outer adhesion of intraarticular, thus affect the activity of shoulder joint.Its lesion characteristic is extensive, i.e. pain is extensive, function limitation extensive,
Tenderness is extensive.The full name of scapulohumeral periarthritis is scapulohumeral periarthritis.
In terms of doctor trained in Western medicine, the clinical characters of primary disease, it is more common in the crowd above middle age that shoulder activity gradually decreases, doctor trained in Western medicine is to scapulohumeral periarthritis
Mainly expectant treatment.Such as composite treatments such as oral anti-inflammatory analgesic, naturopathy, pain spot partial closure, self-massages.West
Although doctor's Therapeutic Method pain relieving instant effect, but can only take stopgap measures, it is impossible to effecting a permanent cure, simply temporary relief of symptoms, after drug withdrawal, majority can be answered
Send out.
In Chinese medicine, primary disease claims " scapulohumeral periarthritis ", " scapulohumeral periarthritis " etc., belongs to arthromyodynia category.Many bodies the most with age are empty, wind-cold damp pathogen take advantage of a weak point in opponent's defence and
Enter, cause to hinder through BI-syndrome involved the blood vessels;Or tumbling down damage, in blood stasis stays, QI and blood is not all right, and muscles along the regular meridians effect is not normal and causes primary disease.The traditional Chinese medical science at present
Main with expelling wind and cold, spasmolytic dredging collateral, activating blood circulation to dissipate blood stasis is Therapeutic Method, is used mostly the treatment means of external application, this treatment hands
Although section instant effect, but radical cure difficulty, need the long-term drug of topical application to treat, and easily recur, and external application serves inconvenience to life band.
A kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture that the present invention relates to is that one optimizes existing microneedle transdermal patch
Novel formulation.On the least area, with micron-sized porous microneedle keratodermatitis, make to be stored in micropin loose structure
Chinese medicine penetrates infiltration epidermal area.Avoid the chemical permeation enhancers overstimulation to skin, simplify percutaneous importing process simultaneously,
It is coated filling liquid using solid lipid nanoparticle suspension as the micropin of ingredient, it is possible to achieve ingredient essence in said preparation
Really, painless, slow release, efficiently, be advantageously administered.
Summary of the invention
It is an object of the invention to overcome the deficiencies in the prior art, it is provided that a kind of cure scapulohumeral periarthritis herbal mixture is microneedle cutaneous
Patch and preparation method, deposit solving common Chinese liniment, liniment, patch and the micropin patch medicine when preparation or actual application
The technical problems such as reserves are little, the sustained release time is short and propose.
The present invention is achieved by the following technical solutions:
A kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture disclosed by the invention, including substrate, medicament, ointment blank patch
With ointment back of the body patch, substrate is positioned at the centre of ointment blank patch and ointment back of the body patch, and substrate uses the material with loose structure, substrate
Front be provided with more than one micropin, the top of micropin is provided with sharp portion, and micropin is vertically fixed on substrate, between micropin have
Having micropin gap, medicament is stored among micropin gap and loose structure, and the back side of substrate is plane, and the back side of substrate is pasted onto
On the inner surface of ointment blank patch, the inner surface of ointment back of the body patch covers on the front of substrate, the inner surface of ointment blank patch and medicine
The inner surface of cream back of the body patch is fixedly connected by the way of pasting.In use, can directly open backing layer will contain patient
The adhesive layer of medicament is attached to affected part, thus realizes the purpose for the treatment of.
Further, in order to ensure the convenience of the microneedle cutaneous patch of herbal mixture and improve therapeutic efficiency, microneedle array is
Multiple, the length of microneedle array and width are all for being designed as 0.5cm, and the spacing between microneedle array is adjacent is 0.1cm, in actual production
In, it is also possible to according to market demand be designed as all size and shape to plaster.
Further, in order to ensure to store more medicine component and the time of increase medicament sustained release, substrate to plaster
The material selected is the one in porous silicon, POROUS TITANIUM or expanded polystyrene or other composites.The selection of substrate is wanted
Possess the loose structure skin simultaneously to human body and will not produce the material of secondary injury.
A kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture disclosed by the invention and preparation method, including following preparation process:
1, the preparation of extracting solution liquid
1) Poria 60~80g, Rhizoma Polygonati 50~70g, the Cortex Eucommiae 60~70g, Cortex Cinnamomi 50~60g, Rhizoma Chuanxiong 40~50g, blood are weighed
Radix seu Caulis fici Martinii 40~50g, Radix seu Caulis Parthenocissi tricuspidatae 40~50g, Folium seu Radix Clausenae dentatae 30~40g, Aleuritopteris argentea (Gmel.) Fee 20~30g, Radix Angelicae Pubescentis 10~20g, mixing is pulverized
After, add the concentration of Ingredients Weight 5~10 times be 50~80% ethanol solution soak at room temperature 3~5 days, cross leaching liquid, then will
Extracting solution rotary evaporation is concentrated into the concentrated solution that water content is 5%~10%.
2) weigh Herba Schizonepetae 40~60g and put in there-necked flask, with extraction by steam distillation 1h, distillate is centrifuged, takes
Layer fluid, obtains Herba Schizonepetae volatile oil.
2, the preparation of herbal mixture solid lipid nanoparticle:
1) take concentrated solution, dissolve with 200~1000ml purified water and 10~50ml Tween-80s, ultrasonic disperse 30 minutes,
It is heated to 65~75 DEG C of insulations standby, prepares aqueous phase.
2) soybean phospholipid and glyceryl monostearate mixture 10~30 grams are weighed in the ratio of 1:1~3:1, with 200~500ml
Ratio be the ethanol/dichloromethane mixture of 4:1 (volume ratio) be that solvent dissolves, add Herba Schizonepetae volatile oil and 0.5~1 gram he
Ke Mosi crude drug continues stirring, and ultrasonic dissolution disperses 15 minutes, prepares oil phase.
3) oil phase injection is being stirred and in the aqueous phase of water bath heat preservation, mixing speed 1500~2000rpm, forming milky white color contamination
Suspension.After continuing insulated and stirred evaporation of organic solvent, ultrasonic disperse 30 minutes, obtain lipid nanoparticle suspension crude product.
4) above-mentioned lipid nanoparticle suspension crude product is injected high pressure homogenizer, to solid in cold water (2~6 DEG C) circulator bath
Lipid nanoparticle suspension crude product carries out high pressure homogenize, sets operating pressure as 2000Bar, after the even concentration of homogenized milk, obtains compound recipe
Solid lipid nanoparticles loaded with traditional Chinese medicine.
3, the preparation of the microneedle cutaneous patch of herbal mixture:
Use laser-etching method that the one side of porous silicon, POROUS TITANIUM or expanded polystyrene baseplate material is cut into microneedle array,
Porous microneedle unit is made with 0.5*0.5cm size;Described microneedle unit is placed on described herbal mixture solid lipid nanoparticle
In, through being coated, filling, take out after drying, described microneedle unit is fixed on the inner surface of ointment blank patch, then is covered with medicine
The cream back of the body pastes and i.e. obtains the microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture.
Further, microneedle array is the arrangement of square formation formula, and unit interval 0.1cm, scope of structuring the formation 2*2cm to 4*4cm are giving birth to
Quantitative flexible selection can be given by different size during product.
Further, the front of substrate forms many micropins after laser-etching method in its surface, and these micropins are on substrate
Forming one group of rectangular-shaped microneedle array, microneedle array is more than one, and the length of microneedle array and width are all 0.5cm, adjacent micropin battle array
Spacing between row is 0.1cm.
Further, the composite of one or more during baseplate material can be selected for porous silicon, POROUS TITANIUM or expanded polystyrene.
The present invention by solid lipid nanoparticle technology and micropin percutaneous technique R. concomitans in percutaneous administration patch, by by slightly solubility
Composition makes solid lipid nanoparticle, improves medicine carrying efficiency, and porous micropin is also equipped with the slow release effect of similar porous microsphere, permissible
Avoiding patient's repeat administration, the pain, the congestive edema that cause various arthritis, hyperosteogeny, traumatic injury etc. extend drug effect.With
Prior art is compared and is had the advantage that, with Chinese medicine as base stock, applicating modern times technology develops a new generation's external subcutaneous administration
Patch, directly acts on subcutaneous by medicine active component, by microneedle cutaneous, has that therapeutic effect is good, its instant effect, right
Human body skin is almost without damage, and have no side effect feature, is the direction of Development of Chinese Medicine.
Accompanying drawing explanation
Fig. 1 is substrate back structural representation;
Fig. 2 is microneedle array structural representation;
Fig. 3 is the product structure schematic diagram of the present invention;
Fig. 4 is the scanning electron microscope (SEM) photograph of substrate loose structure.
Detailed description of the invention
Elaborating embodiments of the invention below, the present embodiment is implemented under premised on technical solution of the present invention,
Give detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.This
Bright include: ointment blank patch inner surface 1, substrate 2, ointment back of the body patch 3, medicament, microneedle array gap 4, sharp portion 5, micro-
Pin 6 and micropin gap 7;
Embodiment 1
As Figure 1-4, substrate 2 is positioned at the centre of ointment blank patch and ointment back of the body patch, and the front of substrate is through laser-etching method
After form many micropins 6 in its surface, these micropins 6 form one group of rectangular-shaped microneedle array on a substrate 2.Substrate 2 is adopted
With having the porous silica material of loose structure, the top of micropin 6 is provided with sharp portion 5, and micropin 6 is vertically fixed on substrate 2,
Having micropin gap 7 between micropin 6, medicament is stored among micropin gap 7 and loose structure, and the back side of substrate 2 is plane,
The back side of substrate 2 is pasted onto on the inner surface 1 of ointment blank patch, and the inner surface of ointment back of the body patch 3 covers on the front of substrate 2,
The inner surface 1 of ointment blank patch is fixedly connected by the way of pasting with the inner surface of ointment back of the body patch, sets between microneedle array
Having microneedle array gap 4, the spacing of adjacent microneedle array is 0.1cm, and the size of microneedle array is 0.5*0.5cm, scope of structuring the formation
2*2cm。
Embodiment 2
In the present embodiment, the material that substrate 2 uses is expanded polystyrene, and substrate 2 has loose structure, the front warp of substrate
Forming many micropins 6 after crossing laser-etching method in its surface, these micropins 6 form one group of rectangular-shaped micropin battle array on a substrate 2
Row, microneedle array is to be arranged in order by multiple micropins 6 to form, and the top of micropin 6 is provided with sharp portion 5, and microneedle array is vertical
Fixing have micropin gap 7 on a substrate 2 between micropin 6, medicament is stored among micropin gap 7 and loose structure, base
The back side of plate 2 is plane, and the back side of substrate 2 is pasted onto on ointment blank patch inner surface 1, and ointment back of the body patch 3 covering is at substrate 2
Front on, ointment blank patch inner surface 1 and ointment the back of the body patch 3 size and shape adapt and opposing parallel setting, micropin
Being provided with microneedle array gap 4 between array, the spacing of adjacent microneedle array is 0.1cm, and the size of microneedle array is 0.5*0.5cm,
The scope of structuring the formation is 4*4cm, in order to paste closely by plaster, can leave 1cm size in the surrounding of ointment blank patch inner surface 1
Paste district, so can improve the sealing effectiveness of plaster, prevent because surrounding covered with dust causes stickup property the strongest.
Embodiment 3
In embodiment 3, the material that substrate 2 uses is porous titanium material, and substrate 2 has loose structure, and the front of substrate 2 sets
Having microneedle array, microneedle array is to be arranged in order by multiple micropins 6 to form, and the top of micropin 6 is provided with sharp portion 5, spine
The big I in portion 5 adjusts the precision of laser-etching according to actual needs and is realized, and microneedle array is vertically fixed on substrate 2, micro-
Having micropin gap 7 between pin 6, medicament is stored among micropin gap 7 and loose structure, and the back side of substrate 2 is plane,
The back side of substrate 2 is pasted onto on the inner surface 1 of ointment blank patch, and the inner surface of ointment back of the body patch 3 covers on the front of substrate 2,
The inner surface 1 of ointment blank patch is fixedly connected by the way of pasting with the inner surface of ointment back of the body patch, sets between microneedle array
Having microneedle array gap 4, the spacing of adjacent microneedle array is 0.1cm, and the size of microneedle array is 0.5*0.5cm, scope of structuring the formation
For 4*4cm.
Embodiment 4
1) weigh Poria 60g, Rhizoma Polygonati 50g, Cortex Eucommiae 60g, Cortex Cinnamomi 50g, Rhizoma Chuanxiong 40g, Radix seu Caulis Verntilaginis Leiocarpae 40g, Radix seu Caulis Parthenocissi tricuspidatae 40g,
Folium seu Radix Clausenae dentatae 30g, Aleuritopteris argentea (Gmel.) Fee 20g, Radix Angelicae Pubescentis 10g, after mixing is pulverized, add 50% ethanol solvent of Ingredients Weight 5 times at room temperature
Soak 5 days, cross leaching liquid, then extracting solution rotary evaporation is concentrated into the concentrated solution that water content is 5%.
2) weigh Herba Schizonepetae 40g, with extraction by steam distillation 1h, distillate is centrifuged, takes upper strata fluid and obtain Herba Schizonepetae volatile oil.
3) take concentrated solution, dissolve with 500ml purified water and 20ml Tween-80, ultrasonic disperse 30 minutes, be heated to 65 DEG C
It is incubated standby, prepares aqueous phase.
4) soybean phospholipid and 20 grams of glyceryl monostearate the mixture, (body with 300ml ratio as 4:1 are weighed in the ratio of 1:1
Long-pending than) ethanol/dichloromethane mixture be that solvent dissolves, add Herba Schizonepetae volatile oil and 0.5 gram of tacrolimus continue stirring, super
Sound dissolves dispersion 15 minutes, prepares oil phase.
5) oil phase injection is being stirred and in the aqueous phase of water bath heat preservation, mixing speed 1500rpm, forming milky suspension.
After continuing insulated and stirred evaporation of organic solvent, ultrasonic disperse 30 minutes, obtain lipid nanoparticle suspension crude product.
6) above-mentioned lipid nanoparticle suspension crude product is injected high pressure homogenizer, to lipid nanoparticle in 2 DEG C of circulating chilled water water-baths
Suspension crude product carries out high pressure homogenize, sets operating pressure as 2000Bar, after the even concentration of homogenized milk, obtains herbal mixture solid fat
Matter nanoparticle.
7) use laser-etching method that the one side of porous silicon-base panel material is cut into microneedle array, make many with 0.5*0.5cm size
Hole microneedle unit;Described microneedle unit is placed in described herbal mixture solid lipid nanoparticle, through being coated, filling, takes
Go out after drying, described microneedle unit is fixed on described adhesive layer, then be covered with described backing layer and i.e. obtain cure scapulohumeral periarthritis herbal mixture
Microneedle cutaneous patch.
Embodiment 5
1) weigh Poria 80g, Rhizoma Polygonati 70g, Cortex Eucommiae 70g, Cortex Cinnamomi 60g, Rhizoma Chuanxiong 50g, Radix seu Caulis Verntilaginis Leiocarpae 50g, Radix seu Caulis Parthenocissi tricuspidatae 50g,
Folium seu Radix Clausenae dentatae 40g, Aleuritopteris argentea (Gmel.) Fee 30g, Radix Angelicae Pubescentis 20g, after mixing is pulverized, the concentration adding Ingredients Weight 10 times is that 80% ethanol is molten
Matchmaker, soak at room temperature 3 days, crosses leaching liquid, then extracting solution rotary evaporation is concentrated into the concentrated solution that water content is 10%.
2) weigh Herba Schizonepetae 60g and put in there-necked flask, with extraction by steam distillation 1h, distillate is centrifuged, take upper strata oil
Liquid obtains Herba Schizonepetae volatile oil.
3) take concentrated solution, dissolve with 1000ml purified water and 50ml Tween-80, ultrasonic disperse 30 minutes, be heated to
75 DEG C of insulations are standby, prepare aqueous phase.
4) soybean phospholipid and 30 grams of glyceryl monostearate the mixture, (body with 500ml ratio as 4:1 are weighed in the ratio of 3:1
Long-pending than) ethanol/dichloromethane mixture be that solvent dissolves, add Herba Schizonepetae volatile oil and 1 gram of tacrolimus continue stirring, ultrasonic
Dissolve dispersion 15 minutes, prepare oil phase.
5) oil phase injection is being stirred and in the aqueous phase of water bath heat preservation, mixing speed 2000rpm, forming milky suspension.
After continuing insulated and stirred evaporation of organic solvent, ultrasonic disperse 30 minutes, obtain lipid nanoparticle suspension crude product.
6) above-mentioned lipid nanoparticle suspension crude product is injected high pressure homogenizer, to lipid nanoparticle in 6 DEG C of circulating chilled water water-baths
Suspension crude product carries out high pressure homogenize, sets operating pressure as 2000Bar, after the even concentration of homogenized milk, obtains herbal mixture solid fat
Matter nanoparticle.
7) use laser-etching method that the one side of expanded polystyrene is cut into microneedle array, make porous with 0.5*0.5cm size
Microneedle unit;Described microneedle unit is placed in described herbal mixture solid lipid nanoparticle, through being coated, filling, takes out
After drying, described microneedle unit is fixed on described adhesive layer, then being covered with described backing layer, i.e. to obtain cure scapulohumeral periarthritis herbal mixture micro-
Pin transdermal administration pastes.
Embodiment 6
1) weigh Poria 70g, Rhizoma Polygonati 60g, Cortex Eucommiae 65g, Cortex Cinnamomi 55g, Rhizoma Chuanxiong 50g, Radix seu Caulis Verntilaginis Leiocarpae 45g, Radix seu Caulis Parthenocissi tricuspidatae 45g,
Folium seu Radix Clausenae dentatae 35g, Aleuritopteris argentea (Gmel.) Fee 25g, Radix Angelicae Pubescentis 15g, after mixing is pulverized, the concentration adding Ingredients Weight 10 times is that 75% ethanol is molten
Matchmaker, soak at room temperature 3 days, crosses leaching liquid, then extracting solution rotary evaporation is concentrated into the concentrated solution that water content is 10%.
2) weigh Herba Schizonepetae 50g, with extraction by steam distillation 1h, distillate is centrifuged, takes upper strata fluid and obtain Herba Schizonepetae volatile oil.
3) take concentrated solution, dissolve with 1000ml purified water and 50ml Tween-80, ultrasonic disperse 30 minutes, be heated to
75 DEG C of insulations are standby, prepare aqueous phase.
4) soybean phospholipid and 30 grams of glyceryl monostearate the mixture, (body with 500ml ratio as 4:1 are weighed in the ratio of 2:1
Long-pending than) ethanol/dichloromethane mixture be that solvent dissolves, add Herba Schizonepetae volatile oil and 1 gram of tacrolimus continue stirring, ultrasonic
Dissolve dispersion 15 minutes, prepare oil phase.
5) oil phase injection is being stirred and in the aqueous phase of water bath heat preservation, mixing speed 2000rpm, forming milky suspension.
After continuing insulated and stirred evaporation of organic solvent, ultrasonic disperse 30 minutes, obtain lipid nanoparticle suspension crude product.
6) above-mentioned lipid nanoparticle suspension crude product is injected high pressure homogenizer, to lipid nanoparticle in 4 DEG C of circulating chilled water water-baths
Suspension crude product carries out high pressure homogenize, sets operating pressure as 2000Bar, after the even concentration of homogenized milk, obtains herbal mixture solid fat
Matter nanoparticle.
7) use laser-etching method that the one side of POROUS TITANIUM is cut into microneedle array, make porous micropin list with 0.5*0.5cm size
Unit;Described microneedle unit is placed in described herbal mixture solid lipid nanoparticle, through being coated, filling, takes out after drying,
Described microneedle unit is fixed on described adhesive layer, then be covered with described backing layer i.e. obtain cure scapulohumeral periarthritis herbal mixture micropin transdermal to
Plaster.
Claims (8)
1. the preparation method of the microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture, it is characterised in that include following preparation process:
1) Poria, Rhizoma Polygonati, the Cortex Eucommiae, Cortex Cinnamomi, Rhizoma Chuanxiong, Radix seu Caulis Verntilaginis Leiocarpae, Radix seu Caulis Parthenocissi tricuspidatae, Folium seu Radix Clausenae dentatae, Aleuritopteris argentea (Gmel.) Fee and Radix Angelicae Pubescentis are weighed, pulverize after mixing, with concentration be 50~80% ethanol solution to mixture soak 3~5 days, filter, after collecting filtrate and described filtrate being evaporated solvent, obtain compound Chinese medicine extract I;
2) weigh Herba Schizonepetae and put in there-necked flask, distillation, to distillate centrifugal treating, stand after being centrifuged, take upper strata fluid, obtain active Chinese drug component thing Herba Schizonepetae volatile oil II;
3) compound Chinese medicine extract I mixed liquor of purified water and Tween-80 is dissolved, ultrasonic disperse 30 minutes, be heated to 65~75 DEG C of insulations, prepare aqueous phase A;
4) by after soybean phospholipid that mass ratio is 1:1~3:1 and glyceryl monostearate mixing, obtain mixture B, with the ethanol/dichloromethane mixed liquor that volume ratio is 4:1, described mixture B is dissolved, obtain solution C, by step 2) in the Herba Schizonepetae volatile oil II of gained and tacrolimus crude drug mix with described solution C three, after ultrasonic disperse, prepare oil phase D;
5) oil phase D injection is being stirred and in the described aqueous phase A of water bath heat preservation, stirring, forming milky suspension E, after insulated and stirred evaporation of organic solvent, ultrasonic disperse, obtain lipid nanoparticle suspension crude product F;
6) by described lipid nanoparticle suspension crude product F injection high pressure homogenizer carries out high pressure homogenize, after concentration, herbal mixture solid lipid nanoparticle G is obtained;
7) use laser-etching method that the front of substrate cuts into the microneedle unit of 0.5*0.5cm size, described microneedle unit is placed in described herbal mixture solid lipid nanoparticle, after being coated, fill and drying, the back side of the substrate after etch processes is pasted on ointment blank patch and has the sticking side, described microneedle unit ointment back of the body exchange premium row covers, it is middle with described ointment back of the body patch that described substrate is positioned at described ointment blank patch, three is fixedly connected by the way of pasting, and obtains the microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture.
The preparation method of a kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture the most as claimed in claim 1, it is characterized in that, the component content of described Poria, Rhizoma Polygonati, the Cortex Eucommiae, Cortex Cinnamomi, Rhizoma Chuanxiong, Radix seu Caulis Verntilaginis Leiocarpae, Radix seu Caulis Parthenocissi tricuspidatae, Folium seu Radix Clausenae dentatae, Aleuritopteris argentea (Gmel.) Fee, Radix Angelicae Pubescentis, Herba Schizonepetae, soybean phospholipid/glyceryl monostearate mixture, Tween-80 and tacrolimus is:
Poria 60~80g
Rhizoma Polygonati 50~70g
The Cortex Eucommiae 60~70g
Cortex Cinnamomi 50~60g
Rhizoma Chuanxiong 40~50g
Radix seu Caulis Verntilaginis Leiocarpae 40~50g
Radix seu Caulis Parthenocissi tricuspidatae 40~50g
Folium seu Radix Clausenae dentatae 30~40g
Aleuritopteris argentea (Gmel.) Fee 20~30g
Radix Angelicae Pubescentis 10~20g
Herba Schizonepetae 40~60g
Soybean phospholipid/glyceryl monostearate mixture 10~30g
Tween-80 10~50ml
Tacrolimus 0.5~1g.
The preparation method of a kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture the most as claimed in claim 1, it is characterized in that, the component content of described Poria, Rhizoma Polygonati, the Cortex Eucommiae, Cortex Cinnamomi, Rhizoma Chuanxiong, Radix seu Caulis Verntilaginis Leiocarpae, Radix seu Caulis Parthenocissi tricuspidatae, Folium seu Radix Clausenae dentatae, Aleuritopteris argentea (Gmel.) Fee, Radix Angelicae Pubescentis, Herba Schizonepetae, soybean phospholipid/glyceryl monostearate mixture, Tween-80 and tacrolimus is:
Poria 80g
Rhizoma Polygonati 70g
Cortex Eucommiae 70g
Cortex Cinnamomi 60g
Rhizoma Chuanxiong 50g
Radix seu Caulis Verntilaginis Leiocarpae 50g
Radix seu Caulis Parthenocissi tricuspidatae 50g
Folium seu Radix Clausenae dentatae 40g
Aleuritopteris argentea (Gmel.) Fee 30g
Radix Angelicae Pubescentis 20g
Herba Schizonepetae 60g
Soybean phospholipid/glyceryl monostearate mixture 10g
Tween-80 50ml
Tacrolimus 1g.
The preparation method of a kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture the most as claimed in claim 2, it is characterized in that, step 2) described in distill the method used be steam distillation, step 3) described in purified water consumption be 200~1000ml.
5. the microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture, it is characterized in that, the described microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture is to be made by either method in the preparation method of a kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture described in Claims 1 to 4.
null6. a kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture as claimed in claim 5,It is characterized in that,Including substrate、Medicament、Ointment blank patch and ointment back of the body patch,Described substrate is positioned at the centre of described ointment blank patch and described ointment back of the body patch,Described substrate uses the material with loose structure,The front of described substrate is provided with more than one micropin,The top of described micropin is provided with sharp portion,Described micropin is vertically fixed on described substrate,There is between described micropin micropin gap,Described medicament is stored among described micropin gap and described loose structure,The back side of described substrate is plane,The back side of described substrate is pasted onto on the inner surface of described ointment blank patch,The inner surface of described ointment back of the body patch covers on the front of described substrate,The inner surface of described ointment blank patch is fixedly connected by the way of pasting with the inner surface of described ointment back of the body patch.
7. a kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture as claimed in claim 5, it is characterised in that the material that described substrate is selected is the one in porous silicon, POROUS TITANIUM or expanded polystyrene.
8. a kind of microneedle cutaneous patch of cure scapulohumeral periarthritis herbal mixture as claimed in claim 6, it is characterized in that, the arrangement of described micropin forms a rectangular-shaped microneedle array, described microneedle array is more than one, the length of described microneedle array and width are all 0.5cm, and the spacing between adjacent described microneedle array is 0.1cm.
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CN111433001A (en) * | 2017-12-05 | 2020-07-17 | 古河电气工业株式会社 | Functional member and method for manufacturing same |
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CN104740304A (en) * | 2015-04-02 | 2015-07-01 | 霍明昌 | Traditional Chinese medicine pills for treating scapulohumeral periarthritis and preparation method thereof |
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