CN109330977A - Lipid substance-coated drug-loaded nanofiber and preparation method thereof - Google Patents
Lipid substance-coated drug-loaded nanofiber and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0092—Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
- D01F8/00—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof
- D01F8/02—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from cellulose, cellulose derivatives, or proteins
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- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
- D01F8/00—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof
- D01F8/04—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from synthetic polymers
- D01F8/14—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from synthetic polymers with at least one polyester as constituent
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- D—TEXTILES; PAPER
- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
- D01F8/00—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof
- D01F8/18—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof from other substances
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Abstract
The invention provides a lipid substance-coated drug-loaded nanofiber and a preparation method thereof. The lipid substance-coated drug-loaded nanofiber is characterized by comprising a core layer and a sheath layer coated outside the core layer, wherein the core layer is the drug-loaded nanofiber, and the raw materials for preparing the sheath layer contain the lipid substance and do not contain drugs. The method has the advantages of simple preparation process, single-step effectiveness, clear structure, small diameter, good linearity, uniform diameter distribution, smooth fiber surface, no bad phenomena of string beads, particles or silk grains mixing and the like of the prepared electrospun drug-carrying nano-fibers wrapped by lipid substance thin layers, and capability of providing good zero-order controlled release effect of the drug. Meanwhile, the method is based on the improved coaxial electrospinning technology, has a simple process and single-step effectiveness, and is suitable for industrial expanded production.
Description
Technical field
The invention belongs to materialogy fields, are related to a kind of electrospinning medicament-carrying nano-fiber with lipid material thin layer package.
Background technique
Medicinal slow controlled-release material is always biological medicine material due to the advantage in " safely, effectively, conveniently " administration
Popular research development object.But since past half a century, the most common method is that drug is dispersed in carrier material
In, by the physicochemical property of carrier material come the slow release of regulating medicine.Wherein most commonly seen carrier material is polymer,
Including which kind of natural polymer and artificial-synthetic copolymer.And on the other hand, due to the biocompatibility of height, lecithin is also normal
Commonly use the sustained and controlled release carrier material of drug.In the exploitation of various drug delivery systems, polymer and lecithin have the phase of oneself
To advantage.Therefore in recent years, some researchs are keen to by polymer and lecithin together use in conjunction, to obtain better medicine
Object delivers effect.In these drug delivery systems, the overwhelming majority is all the hybrid systems of the two, i.e. lecithin-polymer and drug
Multiple components are homogenously mixed together, and these systems mainly exist in the form of particle, especially nanoparticle
(K.Hadinoto,A.Sundaresan,W.S.Cheow,Lipid–polymer hybrid nanoparticles as a
new generation therapeutic delivery platform:a review,Eur.J.Pharm.Biopharm.85
(2013)427–443).
The development of current nanosecond science and technology increasingly emphasizes that nanostructure is assigning the supporting role in material nano function.?
In various complexity nanostructures, core sheath structure be at present most widely used structure feature (N.Kamaly, B.Yameen, J.Wu,
O.C.Farokhzad,Degradable controlled-release polymers and polymeric
nanoparticles:mechanisms of controlling drug release,Chem.Rev.116(2016)2602-
2663.).If can be special in the enterprising step control lecithin of spatial distribution of nano material and the positional structure of polymer material
Sign, forms certain core sheath structure feature, it would be possible to which obtain being blended than common lecithin-polymer is mixed in the better function of material
It can nanometer product.Wherein coaxial electrostatic spinning technology can single step be effectively prepared the function nanos of various core sheath structure features
Material.
High-voltage electrostatic spinning technology is the nano-fabrication technique of a kind of (top-down) from top to bottom, passes through extra electric field power
Overcome spray head tip drop surface tension of liquid and viscoelastic power and form jet stream, in electrostatic repulsion, Coulomb force and surface tension
Under collective effect, the liquid jet after being atomized is drafted thousands of times by high frequency flexural, drawing, division within a few tens of milliseconds, warp
Solvent, which volatilizees, or melt is cooling obtains nano-scale fiber in receiving end.The technical matters process is simple, manipulation is convenient, selection material
In extensive range, controllability is strong and can pass through the nanofiber that sprinkler design preparation has microstructure characteristic, it is considered to be
A kind of most possible method for realizing continuous nano-fibre industrialized production prepares functional nano-fiber with good using the technology
Good prospect.
As the progress of nanosecond science and technology is increasingly by the preparation and application of complicated nano structure material, correspondingly,
The high-voltage electrostatic spinning technology of multi-fluid and the prepared nanofiber with labyrinth feature also become various countries competitively
The popular domain of research and development, especially coaxial electrically spun technology and corresponding core sheath structure nanofiber.Traditional coaxial electrically spun
In, outer sheath fluid must have good electrospinning fibre-forming performance, since this quasi polymer is considerably less, significantly limit tradition
The nanostructure preparative capacibility of coaxial electrically spun technology.In recent years, Yu et al. successfully develops modified coaxial electrically spun technology (Deng-
Guang Yu,Jiao-Jiao Li,Gareth R.Williams,and Min Zhao.Electrospun amorphous
solid dispersions of poorly water-soluble drugs:A review.Journal of
Controlled Release, 2018, Doi:10.1016/j.jconrel.2018.08.016), in the implementation of the technology,
Outer sheath fluid can not have fibre-forming performance.Due to do not have fibre-forming performance fluid it is infinite it is more (such as various small molecule solutions, lotion,
Suspension, dilute polymer etc.), therefore electrospinning is greatly expanded in the preparation of core sheath structure function nano material
Ability.
Summary of the invention
The object of the present invention is to provide a kind of medicament-carrying nano-fiber and preparation method thereof, which has good life
Object compatibility can effectively overcome the Initial burst effect of drug, be conducive to drug slow controlled release for a long time.
In order to achieve the above object, the present invention provides a kind of medicament-carrying nano-fiber of lipid material package, feature exists
In including sandwich layer and the sheaths being wrapped in outside sandwich layer；The sandwich layer is medicament-carrying nano-fiber；The raw material for preparing of sheaths includes
Lipid material does not include drug.
The lipid material may be selected various greases and lipoid, preferably beeswax, tristerin, soybean lecithin,
Egg yolk lecithin and cholesterol etc. be edible and at least one of medicinal lipid material.
The raw material of the medicament-carrying nano-fiber include polymer and drug, the polymer be it is various have electrospinning at
The pharmaceutically acceptable polymer auxiliary material of fine performance, preferred cellulose and its derivative, chitosan, edible protein, ε-polycaprolactone and
At least one of polylactic acid etc..
The present invention also provides the preparation methods of the medicament-carrying nano-fiber of above-mentioned lipid material package, which is characterized in that
Including lipid material to be dissolved in solvent, as sheath portion spinning solution；Drug and polymer are dissolved in solvent, as core spinning
Liquid；Coaxial electrostatic spinning is carried out, the medicament-carrying nano-fiber of lipid material package is prepared.
The present invention has found on the basis of material, medical applications, nanostructure, electrohydrodynamics technology multi-crossed disciplines
Can be with application enhancements type coaxial electrically spun technology, a kind of electrospinning with lipid material thin layer package for going preparation to be invented carries medicine and receives
Rice fiber.The modified coaxial electrically spun technique be a kind of inner core fluid have electrospinning fibre-forming performance and outer sheath fluid does not have
The modified coaxial electrically spun technique of spinning property.The present invention uses modified coaxial electrically spun technique, will not have electrospinning fibre forming property
Can lipid material with for sheath fluid, by the mixed solution with fibre-forming performance polymer and drug with for core liquid, implementation is electric together
Spinning process.By the supper-fast stretching and drying of electro-spinning process, core sheath structure nanofiber, the surface of the nanofiber are prepared
For the lipid material of thin layer, lipid material does not contain drug；The inner core of fiber is the compound of drug and polymer.Due to lipid
Thin layer changes the surface layer enrichment phenomenon of drug, simultaneously because the hydrophobic effect of lipid material, therefore can improve drug from poly-
The performance for closing slow controlled release in object, obtains good medicine controlled releasing effect.
Heretofore described nanofiber is collectively constituted by lipid material and drug-carrying polymer fiber hybrid, lipid material
Medicament-carrying nano-fiber surface, which is wrapped in, with thin layer approach forms core sheath structure feature.The nanofiber can effectively eliminate general
The drug Initial burst effect of logical medicament-carrying nano-fiber, obtains better medicine sustained and controlled release performance.This fiber have surface without
The characteristics of medicine, good biocompatibility.
Compared with prior art, the beneficial effects of the present invention are:
The characteristics of nanofiber of the invention, is: 1) lipid film package not drug containing, so that fiber surface is without drug；2)
Lipid material has good biocompatibility；3) under human body temperature, lipid material is easily dispersed；4) drug can effectively be overcome
Initial burst effect；4) be conducive to drug slow controlled release for a long time.The method of the present invention preparation process is simple, and single step is effective, makes
The electrospinning medicament-carrying nano-fiber of standby lipid material thin layer package is clear in structure, diameter is small, good linearity, diameter are evenly distributed, fine
Dimension table face is smooth, mixes etc. bad phenomenons without a beading, particle or silk grain, is capable of providing good drug Zero order controlled releasing effect.
Simultaneously the present invention is based on coaxial electrically spun technology is improved, simple process, single step is effective, is suitable for industrial expanded production.
Detailed description of the invention
The schematic diagram of the section structure of the medicament-carrying nano-fiber of Fig. 1 lipid material package；
Fig. 2 modified coaxial electrically spun schematic diagram.
Fig. 3 has the scanning electron microscope diagram (500 ×) of the electrospinning medicament-carrying nano-fiber of lipid material thin layer package.
Fig. 4 has the transmission electron microscope figure (200,000 of the electrospinning medicament-carrying nano-fiber of lipid material thin layer package
×)。
The external medicine controlled releasing figure of Fig. 5 electrospinning medicament-carrying nano-fiber: the common electrospinning medicament-carrying nano-fiber of a-；B- is of the invention
Electrospinning beeswax thin layer wraps up brufen/ethyl cellulose nanofiber.
Specific embodiment
Present invention will be further explained below with reference to specific examples.It should be understood that these embodiments are merely to illustrate the present invention
Rather than it limits the scope of the invention.In addition, it should also be understood that, after reading the content taught by the present invention, those skilled in the art
Member can make various changes or modifications the present invention, and such equivalent forms equally fall within the application the appended claims and limited
Range.
Embodiment 1: modified coaxial electrically spun device is built
According to document, (Xu Fangliang, Xu Ying, the remaining wide dilute polymer circulation coaxial electrically spun of lamp prepare drug Zero order controlled releasing
Nanofiber Shanghai University of Science and Technology journal, 2015,37 (2): 165-168.) modified coaxial electrically spun device is built, described changes
Include two axis stream syringe pumps, a coaxial spinneret into type coaxial electrically spun device, a fiber receives plate and a high pressure
Electrostatic potential source, two axis stream syringe pumps, wherein being equipped with core liquid syringe on a platform, which can be directly connected to coaxial spinning
Head.Sheath liquid syringe is housed on another platform, and sheath fluid is transported to by coaxial spinneret, high-pressure electrostatic electricity by high elasticity silica sebific duct
Source is connected by alligator forceps with coaxial spinneret, and fiber receives plate ground connection.
Embodiment 2: the allotment of spinning solution and the implementation of modified coaxial electrically spun
5.0g beeswax is dissolved in 100 milliliters of DMAC N,N' dimethyl acetamides (DMAc) and ethyl alcohol at normal temperature, and (volume ratio is
In the mixed solvent 30:70), mixes yellow solution, as sheath portion spinning solution.
By 5.0g brufen and 20.0g ethyl cellulose (range of viscosities 8-12mPa.s) co-dissolve in 100 milliliters of second
In alcohol, clear solution is formed, as core spinnable solution.
Implement common single fluid electrospinning processes and modified coaxial electrostatic spinning technique under following process conditions, prepares general
It is powered and spins medicament-carrying nano-fiber and beeswax thin layer package brufen/ethyl cellulose nanofiber.Wherein, modified coaxial electrostatic
Spinning technique is using the modified coaxial electrically spun device in embodiment 1.
Beeswax thin layer wraps up brufen/ethyl cellulose nanofiber: core flow velocity is 2.0mL/h, and sheath flow velocity is
0.5mL/h, receiver board are 15cm, voltage 12kV with a distance from spinning nozzle.Environment temperature be (23 ± 1) DEG C, ambient humidity be 62 ±
4%, electro-spinning process is as shown in Figure 2.
As shown in Figure 1, resulting beeswax thin layer package brufen/ethyl cellulose nanofiber includes sandwich layer and package
Sheaths outside sandwich layer, the sandwich layer are medicament-carrying nano-fiber, are made of polymer at fine substrate 3 and drug 2, in sheaths
Comprising beeswax 3, drug is not included.
Common electrospinning medicament-carrying nano-fiber: core flow velocity is 2.0mL/h, and sheath flow velocity is 0mL/h, and receiver board is from spinning nozzle
Distance is 15cm, voltage 12kV.Environment temperature is (23 ± 1) DEG C, and ambient humidity is 62 ± 4%.
Embodiment 3: the pattern and structural characterization of the electrospinning medicament-carrying nano-fiber with lipid material thin layer package
It is observed after carrying out surface spray carbon to fiber prepared by embodiment 2 using field scan Electronic Speculum (FESEM), in amplification 500
Under the conditions of times, as a result as shown in Figure 3.Prepared fiber has good linearity, uniform in size, spindle does not occur or silk grain mixes
Phenomena such as, reflect that prepared beeswax thin layer package brufen/ethyl cellulose nanofiber has good shape characteristic.
Internal structure is further carried out to prepared fiber using transmission electron microscope (TEM), is amplifying 200,000 times of condition
Under, as a result as shown in Figure 4.Fiber core sheath structure feature is obvious, and a thin layer of beeswax layer without drug is wrapped up in outside, ash
Degree is less than the drug-polymer composite layer of core.
Embodiment 4: the external medicine controlled releasing performance evaluation of the electrospinning medicament-carrying nano-fiber with lipid material thin layer package
By 2015 editions annex of Chinese Pharmacopoeia, Ⅹ D drug release determination the second method slurry processes, experiment instrument is intelligently dissolved out using RCZ-8A
It carries out carrying out In Vitro Dissolution test to above-mentioned resulting beeswax thin layer package brufen/ethyl cellulose nanofiber.Control turns
Fast 50rpm, temperature are 37 ± 0.1 DEG C, using the phosphate buffer solution of 900mL pH6.8 as dissolution medium, investigate the body of drug
Slow controlled release properties outside.5mL is sampled on schedule, obtains dissolution fluid sample, and supplements same volume isothermal fresh medium at once.It is right
After sample suitably dilutes, at λ=260nm, ultraviolet determination is carried out using ultraviolet-uisible spectrophotometer, calculates medicine ibuprofen
Accumulation dissolve out percentage, be repeated 6 times.It is as shown in Figure 5 that vitro Drug dissolves out releasing result, it is evident that compared to single Bu Luo
Sweet smell/ethyl cellulose nanofiber, beeswax thin layer, which wraps up brufen/ethyl cellulose nanofiber, has better medicament slow release
Performance is in particular in, essentially eliminates the Initial burst effect of drug, drug release rate is gentler, while drug release
Time it is longer.The reason is that the beeswax thin layer of outside eliminates the fiber surface enrichment phenomenon of drug, simultaneously because beeswax
Hydrophobic effect has delayed diffusion process of the drug from polymeric substrate to dissolution fluid.
Embodiment 5: paracetamol/ethyl cellulose nanofiber of electrospinning soybean lecithin package
Referring to embodiment 2,5.0g soybean lecithin is dissolved at normal temperature in 100 milliliters of methylene chloride, is mixed light
Brown solution, as sheath portion spinning solution.By 5.0g paracetamol and 20.0g ethyl cellulose co-dissolve in 100 milliliters of second
In alcohol, clear solution is formed, as core spinnable solution.Implement modified coaxial electrostatic spinning work under following process conditions
Skill, paracetamol/ethyl cellulose nanofiber of preparation electrospinning soybean lecithin package: core flow velocity is 1.0mL/h, sheath fluid
Flow velocity is 0.2mL/h, and receiver board is 20cm, voltage 15kV with a distance from spinning nozzle.Resulting soybean lecithin package flutters hot breath
Bitterly/ethyl cellulose nanofiber includes sandwich layer and the sheaths that are wrapped in outside sandwich layer；The sandwich layer is medicament-carrying nano-fiber,
The raw material for preparing of sheaths includes lipid material soybean lecithin, does not include drug.
Embodiment 6: ferulic acid/ε-polycaprolactone nanofiber of electrospinning beeswax package
Referring to embodiment 2,5.0g beeswax is dissolved in 100 milliliters of n,N-dimethylacetamide (DMAc) and second at normal temperature
The in the mixed solvent of alcohol (volume ratio 30:70), mixes yellow solution, as sheath portion spinning solution.By 5.0g ferulic acid and
10.0g ε-polycaprolactone co-dissolve forms clear solution, as core spinnable solution in 100 milliliters of chloroform.Following
Implement modified coaxial electrostatic spinning technique, ferulic acid/ε-polycaprolactone nanometer of preparation electrospinning beeswax package under process conditions
Fiber: core flow velocity is 2.0mL/h, and sheath flow velocity is 0.5mL/h, and receiver board is 15cm, voltage 8kV with a distance from spinning nozzle.Institute
Ferulic acid/ε-polycaprolactone nanofiber of beeswax package include sandwich layer and the sheaths that are wrapped in outside sandwich layer；Described
Sandwich layer is medicament-carrying nano-fiber, and the raw material for preparing of sheaths includes lipid material beeswax, does not include drug.
Claims (4)
1. a kind of medicament-carrying nano-fiber of lipid material package, which is characterized in that including sandwich layer and the sheath being wrapped in outside sandwich layer
Layer；The sandwich layer is medicament-carrying nano-fiber；The raw material for preparing of sheaths includes lipid material, does not include drug.
2. the medicament-carrying nano-fiber of lipid material as described in claim 1 package, which is characterized in that the lipid material is
At least one of beeswax, tristerin, soybean lecithin, egg yolk lecithin and cholesterol.
3. the medicament-carrying nano-fiber of lipid material package as described in claim 1, which is characterized in that the medicament-carried nano is fine
The raw material of dimension includes polymer and drug, and the polymer is cellulose and its derivates, chitosan, edible protein, ε-
At least one of polycaprolactone and polylactic acid.
4. the preparation method of the medicament-carrying nano-fiber of lipid material package of any of claims 1-3, feature exist
In, including lipid material is dissolved in solvent, as sheath portion spinning solution；Drug and polymer are dissolved in solvent, as core
Spinning solution；Coaxial electrostatic spinning is carried out, the medicament-carrying nano-fiber of lipid material package is prepared.
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| CN110812343A (en) * | 2019-12-13 | 2020-02-21 | 文黎明 | Sustained-release chemotherapy microparticles and preparation method and application thereof |
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