CN104414975B - Transdermal spray agent of plasticity mist membranization and preparation method thereof - Google Patents
Transdermal spray agent of plasticity mist membranization and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of transdermal spray agent of plasticity mist membranization and preparation method thereof, the transdermal spray agent of the plasticity mist membranization, it is made up of the component of following parts by weight percentage：Medicine 2%~20%, meso-porous nano aerosil 2%~20%, dispersant 2%~30%, Alevaire 1%~15%, film forming agent 1%~15%, solvent flashing 35%~90%.Meso-porous nano aerosil is controlled release meso-porous nano carrier, porosity 90% 99.8%；Aperture is 20~100nm；Three-dimensional manometer particle diameter is 2~70nm；The 1000m of specific surface area 1002/g；Density 0.003g 30g/cm3；The 0.018w/mk of thermal conductivity factor 0.01.The present invention can effectively realize the sustained transdermal of medicine long period, maintain constant blood concentration, and preparation percutaneous absorption rate is fast, and Transdermal absorption amount is high, have the characteristics of stable, efficient.
Description
Technical field
The present invention relates to a kind of plasticity mist membranization transdermal spray agent and its system using meso-porous nano silica as carrier
Preparation Method.
Background technology
At present, deposited by interaction in vitro in the conventional preparation containing medicine of human body, mainly patch, gel, emulsifiable paste
In many defects, if patch is to skin irritation caused by the closure function of skin；Medicine caused by crystallization of the medicine in patch
Quality problem；And after the administration of large area patch product, influence attractive in appearance etc..Semisolid dosage form such as gel and ointment, it is most
Major problem is that can not dosed administration exactly, easily removed because of friction, not only influence transdermal effect, and pollution clothes,
Reduce patient's compliance.
Ketoprofen, brufen etc. are conventional NSAIDs (NSAIDs).Ketoprofen has a chiral centre, and one
As Clinical practice is supplied all in the form of racemic modification, but only d-isomer just has anti-inflammatory antirheumatic and analgesic activity, left-handed
Body does not almost have pharmacological activity.Exploitation of the developed country to single enantiomer is extremely paid attention to, and most of drugmakers start to consider
Chiral drug branch is established in their drug development portion.FDA has early just issued the guidance about chiral drug in 1992
Principle, new drug research from now on develop the direction increasingly towards single enantiomer.The use of dexketoprofen advantageously reduces
The toxicity of medicine and influencing each other between nonactive enantiomer, can because his activity is 2 times of racemic modification
To supply Clinical practice using the dosage of racemic modification half, it can so mitigate the burden of liver and the formation of whole metabolin.
There is potential acylation reaction between the acyl glucose aldehydic acid metabolin and protein of other Ketoprofen, easily induce Immune Sensibility
With the selective toxicity of tissue, and d-isomer because eliminating the acyl glucose aldehydic acid of levo form so as to reducing this active generation
Thank to the quantity of product, this patient bad to those hepatic and renal functions is especially useful.
Dexketoprofen is developed by Italian Menarini companies, is listed first in Spain in 1996.So far, there is the right side
Revolve the oral formulations and injection of Ketoprofen.
Studying data at home and abroad shows that Ketoprofen has the selectivity of height to COX-1 inhibitory action.Experiment in vitro table
Bright, stronger to COX-2 inhibitory action, its IC50 is 0.024 μm of ol/L, by contrast, levo form in very high concentration (>1μ
Mol/L could produce 40% inhibitory action, it is believed that it is relevant to contain micro d-isomer with it.Observe to intact cell COX-2
Inhibitory action, it is found that suppression IC50 of the d-isomer to monocyte COX-2 is 2~25 μm of ol/L, be levo form 100~
500 times.It can therefore be concluded that going out, chiral NSAIDs has certain selectivity to COX-1 and COX-2 inhibitory action, in the past
Observed racemic modification is as caused by d-isomer to COX-2 inhibitory action.
The most common adverse reactions of NSAIDs are gastrointestinal toxicities, especially most common with the elderly and long-term prescription person.Most
Serious adverse reaction is hemorrhage of gastrointestinal tract, in addition also protein reduction, bile malabsorption etc..Toxicity research shows,
Rat 10~20mg/kg of single oral dose d-isomers do not influence on intestinal mucosa, and 20~40mg/kg racemic modification is to small intestine
There are a significantly damages with cecum mucosa, caused by this toxicity is probably the synergy between levo form and d-isomer.Medicine generation
Dynamics research shows that health volunteer's single takes 12.5mg or 25mg, can reach peak in 0.25-0.75 hours blood concentration
Value, Cmax is respectively 1.4mg/L and 3.1mg/L.Dexketoprofen is mainly with prototype medicine, hydroxylation metabolism thing and corresponding grape
The form of glycuronide metabolin is present.About 70-80% medicine is mainly latter 12 hours in clothes in the form of glucuronide conjugate
Drained from urine.
Rheumatoid arthritis is the frequently-occurring disease of serious threat human health, common disease, be using multi-joint chronic inflammation as
The autoimmune disease mainly showed, disability rate are higher.Pain is one of most common symptom of malignant tumor patient.According to generation
Boundary health organization statistics, the annual new cancer patient 7,000,000 in the whole world, wherein 30%-50% is with different degrees of pain, seriously
Influence the daily life of patient.The pain of cancer patient can be alleviated by implementing tumour analgesia therapy.It is demonstrated experimentally that KPF is a kind of slow
The active drug of solution and treatment of cancer pain, oral KPF analgesic effect is quite or better than morphine.Dexketoprofen has analgesia concurrently
And antipyretic properties, clinically it is mainly used in treating ankylosing rachitis, rheumatoid arthritis and osteoarthritis, foreign countries are also
For postoperative analgesia, dentistry pain, acute visceral pain, acute injury of muscle, chronic cancer pain and primary dysmenorrhea etc..
The content of the invention
It is an object of the invention to provide a kind of transdermal spray agent of plasticity mist membranization and preparation method thereof, to improve patient
The compliance of medication.
The transdermal spray agent of described plasticity mist membranization, is made up of the component of following parts by weight percentage：
Preferably
The meso-porous nano aerosil is controlled release meso-porous nano carrier, porosity 90%-99.8%；Aperture is 20
~100nm；Three-dimensional manometer particle diameter is 2~70nm；Specific surface area 100-1000m2/g；Density 0.003g-30g/cm3；Thermal conductivity factor
0.01-0.018w/m·k。
The meso-porous nano aerosil, the hydrophobic of Germany and Britain Ai Lisheng Asia-Pacific Electronics Co., Ltd. production can be used
Property, hydrophily or the aerosil of both sexes；Density 12.5-18kg/m3, specific surface area 500-650m2/ g, porosity 95-
98%, aperture 10-70nm, pore volume 3.5ml/g, thermal conductivity factor 0.01-0.018w/mk.
The dispersant includes isopropanol, ethanol, propane diols, glycerine, n-octyl alcohol or n-dodecanol；It is preferred that propane diols；
Described Alevaire is selected from sulfoxide type, pyrrolones, terpenes, amine, phosphide class, Laurocapram, surface work
Property agent, sldium lauryl sulfate, aliphatic acid or fatty acid ester；
The sulfoxide type is selected from dimethyl sulfoxide (DMSO) or Kui methyl sulfoxide；
The pyrrolones include 2- pyrrolones, 5- methyl -2- pyrrolones, 1,5- dimethyl -2- pyrrolones, N- methyl pyrroles
Iron alkanone；
The terpenes include cineole, limonene or flores aurantii tree alcohol；
The phosphide class includes lecithin, Fabaceous Lecithin or phosphatidyl glycerol；
The aliphatic acid includes oleic acid or laurate；
The fatty acid ester includes LA, isopropyl myristate, propylene glycol dipelargonate or decanedioic acid two
Ethyl ester；
Most preferably, Alevaire possesses the ability of excellent dissolution medicine thoroughly, selected from isopropyl myristate, azone or bay
Alcohol lactate；
The film forming agent is alcohol-soluble hydrophilic macromolecule, including cellulose derivative such as acrylic resin, hydroxypropyl are fine
Tie up element, copolyvidone, preferably low molecular weight polyvinyl pyrrolidone, polyvinylpyrrolidone（PVP-K12、PVP-K15、PVP-
K30）.There is good compatibility with the solvent in decoction and Alevaire.And it is administered after acting on skin, can has and hold well
Attached property, resist washing property and good outward appearance.
Described volatile solvent, can be ethyl acetate, low molecule alcohol etc..
Most preferably, ethanol and propane diols are selected from security consideration, solvent flashing；
The medicine is dexketoprofen or brufen；
The preparation method of the transdermal spray agent of described plasticity mist membranization, comprises the following steps：
(1) membrane material is added in solvent flashing, and adds Alevaire, form uniform solution system；
(2) medicine is added in dispersant, forms uniform drug containing dispersion；
(3) controlled release meso-porous nano carrier material is put into（2）In the dispersion of preparation, ultrasound 20~40 minutes, make Jie
Hole nano carrier material effectively adsorbs medicine, forms the controlled release system for containing medicine；
(4) will（1）The solution system of preparation with（3）The controlled release system mixing of preparation, ultrasound degassing, you can described in obtaining
The transdermal spray agent of plasticity mist membranization.
The mechanism of action of the present invention is such：
Decoction acts on skin, and then solvent volatilizees, and forms drug-reservoir, and then medicine slowly discharges.
The transdermal spray agent of the plasticity mist membranization of invention, can by constant displacement pump, by the decoction of correct dose with vaporific or
The form of person's liquid acts on skin, and after administration, the plastic membrane of atomization is formed in skin surface, and solvent evaporates rapidly in decoction,
Medicine then forms " stealthy bank " in skin surface.Therefore, solution system, which is applied to cutaneous penetration, to be produced because of closure function
The raw excitant to skin, also, combine the use of constant displacement pump, moreover it is possible to solve the problems, such as dosed administration.
In order to solve in spraying system application process, because solvent volatilization causes the quick crystallization of medicine, so as to influence medicine
Transdermal absorption, inventor find, using the mesoporous absorption of aerosil and Drug controlled release, load can be increased simultaneously
Dose.
The architectural feature of the aerosil is to possess the cylindrical shape multi-branched nanoporous three of high-permeability
Network structure, possess high hole ratio, extremely low density, high-specific surface area, superelevation pore volume rate, its volume density is in 0.003-
0.500g/cm3In the range of it is adjustable（The density of air is 0.0129g/cm3）.Possessed by mesopore silicon dioxide nano material greatly
Specific surface area, higher porosity, regular orderly pore passage structure, make it the advantages that homogeneous adjustable aperture and physiological-toxicity-free
As the excellent carrier of medicine.Wherein there is MCM-41 and SBA-15 (Santa as pharmaceutical carrier most study is most representational
Barbava USA, SBA) two kinds of Metaporous silicon dioxide materials.In general, mesoporous silicon oxide utilizes its huge surface area
And strong adsorption capacity, drug molecule can be carried on inside its nano pore, and slowly lasting release medicine；To the present invention
For patent drug, by the regulation to mesoporous silicon oxide aperture and internal gutter topological structure, its nanometer can be relied on
Duct or three-dimensional structure, medicine is present in inside duct with molecule or amorphous absorption, so as to effectively control medicine
Rate of release, increase drugloading rate, suppress crystallization.
Decoction shows that the composition, spray type and operating condition of the plastic membrane and atomized liquid to be formed have in skin
Close.Solution relative density and viscosity play the part of less role in sprayer output quantity, due to it is most of be aqueous solvent, but work as mist
When changing viscosity higher solution, viscosity is exactly an important factor.Research shows, for low viscosity liquid, caused liquid is big
It is small directly proportional to liquid viscosity, and influence of the relative density to droplet size is smaller.Influence of the viscosity to the size of drop is more
It is complicated.Sprayer for giving solution, operating pressure are to determine the principal element of sprayer output quantity.Result of the test shows to grasp
The output quantity for making pressure and medicine has functional relation.
For the spraying system of the present invention in use, dosage is once a day, one time one spray, is suitable using area as 12-24cm2
Preferably.Dexketoprofen metered dose preparation provided by the invention, dispersant allow medicament to be uniformly dispersed in solvent system,
Film forming agent can help product closely to paste skin, and wherein Alevaire helps to open skin passage, the transdermal suction of significantly increasing medicament
Receive；Meso-porous nano carrier material effectively adsorbs medicine, forms the controlled release system for containing medicine, realizes the controlled release of medicine, and
And after volatilizing the solvent flashing short time, drug concentration increases sharply, the presence of meso-porous nano carrier material can suppress medicine
Crystallization.
The transdermal spray agent of plasticity mist membranization provided by the invention, the compliance of patient medication can be improved.Animal is tried
Verify the transdermal spray agent of bright, of the invention plasticity mist membranization, the insoluble drug release that 24 hours can be continued and transdermal.Given at this
Medicine is released into human body by skin in medicine system plays drug effect, while is able to maintain that stable blood concentration, and reduction is taken
Frequency, increase the compliance and compliance of patient；Transdermal route avoids first cross of the drug oral through intestines and stomach and liver and imitated simultaneously
Should, there is higher bioavilability, had a clear superiority in medical applications.Holding for medicine long period can effectively be realized
It is continuous transdermal, constant blood concentration is maintained, and preparation percutaneous absorption rate is fast, Transdermal absorption amount is high, has stable, efficient special
Point.
Brief description of the drawings
Fig. 1 is accumulation dermal penetration rate figure of the medicine in 24 hours.
Embodiment
Prescription is shown in Table 1, table 2 and table 3.Table 1 is decentralized system, and table 2 is controlled release system, and table 3 is respectively：Embodiment 1+7=reality
Apply example 13, embodiment 2+8=embodiment 14, by that analogy.
Table 1, embodiment 1-6
Table 2, embodiment 7-12
Embodiment 13-18 is the mixture of two solution systems of Tables 1 and 2.After mixing, ultrasound degassing, efficiently moulded
The transdermal spray system of property mist membranization.Select different sprayer units.Composition is as follows：
Table 3, embodiment 13-18
Successively embodiment 1-18 detect using measurement of size of aerosol standard, the results are shown in Table 4：
Table 4, atomized flow is adjusted, in 4L/min, 8L/min, with the particle diameter of the above-mentioned prescription aerosol of laser diffractometry measure
As a result prove that mass size medians of embodiment 13-18 when 4L/min, 8L/min atomized flow meets that this is
The quality requirement of system administration.
With reference to metered dose agent, quality evaluation is carried out to embodiment 13-18：
Administration area evaluation after administration every time, weighing area is 100cm2The quality of the paper of (10 × 10cm), it is
0.8952g.To prepare metered dose agent from same blank sheet of paper 5cm at, decoction is sprayed on paper.The portion of humidity is will appear from paper
Point, cut the part along margin line after profile is sketched the contours with pen and weigh.It is repeated 6 times, then active area is administered every time with following public affairs
Formula calculates：
Ax=0.8952×100/Wx
It the results are shown in Table 5：
The measure of active area is administered in the metered dose agent of table 5（n=6）
Embodiment 13-18 preparation prescriptions are put in 30 ° of inclinations, weighed after 3 days, tilts with not 30 ° and claimed when putting before 3 days
Weight results contrast.Unknown significance difference.
Homogeneity per spray amount is investigated.Weighed in metered dose agent after 0,1,5,10,20,40 time.Per spray amount
Weight is the number of reduced weight divided by ejection.Experimental result is as follows：
The above results show that the present invention provides the new preparation capable of permeating skin using penetrating agent as pharmaceutical carrier, can improve patient
The compliance of medication.The sustained transdermal of medicine long period can be effectively realized, maintains constant blood concentration, and preparation is transdermal
Absorption rate is fast, and Transdermal absorption amount is high, has the characteristics of stable, efficient.
The present invention and relative theory are equally applicable to the medicine of similar physicochemical properties, such as brufen.
According to《Percutaneous dosing novel form》（Zheng Jun democracy is compiled, and People's Health Publisher publishes）The method of middle offer, use
Franz diffusion cells, selection and the immediate in vitro porcine skin of application on human skin carry out permeation test in vitro, measure embodiment 13~18
Preparation is in the infiltration rate of in vitro porcine skin, and as a result such as table 4, accumulation dermal penetration rate of the embodiment preparation in 24 hours is shown in
Fig. 1.
The dermal penetration rate of medicine in 6 different embodiments of table
。
Claims (7)
1. the transdermal spray agent of plasticity mist membranization, it is characterised in that be made up of the component of following parts by weight percentage：
The percentage sum of component is 100%；
The meso-porous nano aerosil is controlled release meso-porous nano carrier, porosity 90%-99.8%；Aperture be 20~
100nm；Three-dimensional manometer particle diameter is 2~70nm；Specific surface area 100-1000m2/g；Density 0.003g-30g/cm3；Thermal conductivity factor
0.01-0.018w/m·k；
The medicine is dexketoprofen or brufen.
2. the transdermal spray agent of plasticity mist membranization, it is characterised in that be made up of the component of following parts by weight percentage：
The percentage sum of component is 100%；
The meso-porous nano aerosil is controlled release meso-porous nano carrier, porosity 90%-99.8%；Aperture be 20~
100nm；Three-dimensional manometer particle diameter is 2~70nm；Specific surface area 100-1000m2/g；Density 0.003g-30g/cm3；Thermal conductivity factor
0.01-0.018w/m·k；
The medicine is dexketoprofen or brufen.
3. the transdermal spray agent of plasticity mist membranization according to claim 1, it is characterised in that the meso-porous nano dioxy
SiClx aeroge is hydrophobicity, hydrophily or the aerosil of both sexes.
4. the transdermal spray agent of plasticity mist membranization according to claim 2, it is characterised in that the meso-porous nano dioxy
SiClx aeroge is hydrophobicity, hydrophily or the aerosil of both sexes.
5. the transdermal spray agent of plasticity mist membranization according to claim 1, it is characterised in that the dispersant is selected from different
Propyl alcohol, ethanol, propane diols, glycerine, n-octyl alcohol or n-dodecanol.
6. the transdermal spray agent of plasticity mist membranization according to claim 1, it is characterised in that described Alevaire is selected from
Sulfoxide type, pyrrolones, terpenes, amine, phosphide class, Laurocapram, surfactant, aliphatic acid or fatty acid ester；
The sulfoxide type is selected from dimethyl sulfoxide (DMSO) or Kui methyl sulfoxide；
The pyrrolones are selected from 2- pyrrolones, 5- methyl -2- pyrrolones, 1,5- dimethyl -2- pyrrolones, N- methyl pyrroles and iron alkane
Ketone；
The terpenes are selected from cineole, limonene or flores aurantii tree alcohol；
The phosphide class is selected from lecithin, Fabaceous Lecithin or phosphatidyl glycerol；
The aliphatic acid includes oleic acid or laurate；
The fatty acid ester is selected from LA, isopropyl myristate, propylene glycol dipelargonate or diethyl sebacate；
The film forming agent is acrylic resin, hydroxypropyl cellulose, copolyvidone, low molecular weight polyvinyl pyrrolidone；
Described volatile solvent, it is ethyl acetate or low mass molecule alcohol.
7. the preparation method of the transdermal spray agent of the plasticity mist membranization according to any one of claim 1~6, its feature exist
In comprising the following steps：
(1) film forming agent is added in solvent flashing, and adds Alevaire, form uniform solution system；
(2) medicine is added in dispersant, forms uniform drug containing dispersion；
(3) controlled release meso-porous nano carrier material is put into the dispersion of (2) preparation, ultrasound 20~40 minutes, makes mesoporous receive
Rice carrier material effectively adsorbs medicine, forms the controlled release system for containing medicine；
(4) solution system prepared by (1) is mixed with controlled release system prepared by (3), ultrasound degassing, you can obtain described plasticity
The transdermal spray agent of mist membranization.
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| CN105906435A (en) * | 2016-04-27 | 2016-08-31 | 安徽乙地生态科技有限公司 | Fogging agent for spraying and preparation method thereof |
| CN109755113B (en) * | 2017-11-01 | 2021-08-10 | 天津环鑫科技发展有限公司 | Primary diffusion process for adjusting diffusion atmosphere |
| CN109911907A (en) * | 2017-12-13 | 2019-06-21 | 天津龙华诚信粉体技术有限公司 | A kind of preparation method and product of ultra-fine high oil absorption value food grade silicon dioxide |
| CN111743976A (en) * | 2020-07-03 | 2020-10-09 | 广西医科大学 | Application of silicon dioxide aerogel in preparation of osteoarthritis treatment drug |
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| CN102018671A (en) * | 2011-01-05 | 2011-04-20 | 浙江大学 | Estradiol transdermal spray and preparation method thereof |
| CN102199312A (en) * | 2011-03-07 | 2011-09-28 | 青岛大学 | Mesoporous silica particle compound carrier with controlled-release function as well as preparation method and application thereof |
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| CN102018671A (en) * | 2011-01-05 | 2011-04-20 | 浙江大学 | Estradiol transdermal spray and preparation method thereof |
| CN102199312A (en) * | 2011-03-07 | 2011-09-28 | 青岛大学 | Mesoporous silica particle compound carrier with controlled-release function as well as preparation method and application thereof |
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