CN110478517A - A kind of loading nano silvery and the medical dressing of bioactie agent and preparation method thereof - Google Patents
A kind of loading nano silvery and the medical dressing of bioactie agent and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/44—Medicaments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
- A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L2300/104—Silver, e.g. silver sulfadiazine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
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Abstract
The present invention relates to a kind of preparation method of chronic wound dressing, a kind of specifically a kind of loading nano silvery and the medical dressing of bioactie agent and preparation method thereof.Dressing includes that calcium alginate, chitosan or chitosan derivatives are matrix, loading nano silvery bacteria inhibiting composition particle and growth factor EGF.It is added dropwise in preparation to calcium chloride solution and is mixed with the calcium alginate core microballoon for obtaining package growth factor in the sodium alginate soln of growth factor.Microballoon is added to chitosan-acetic acid solution and forms compound polyelectrolyte.Compound polyelectrolyte and nano silver, chitosan are mixed again, is added in sodium alginate and is crosslinked, is freeze-dried, ultimately forms the chronic wound dressing of loading nano silvery and growth factor.The method of the present invention raw material is cheap and easy to get, preparation process is stablized, and chronic wound dressing bacteriostasis property is good, and wound repair ability is excellent, for the treatment of all kinds of chronic wounds caused by cancer radiation therapy and diabetes, ischemic etc., surface of a wound cleaning is induced to repair.
Description
Technical field
The invention belongs to medical dressing fields, are related to a kind of medical dressing repaired applied to chronic wound cleaning, specifically
It is a kind of loading nano silvery and chronic wound dressing of bioactivity growth factor and preparation method thereof.
Background technique
Skin divides epidermis and two layers of corium, and epidermis can be divided into cuticula and germinal layer two parts in skin surface.Epidermis
Belong to stratified squamous epithelium, corium is then dense connective tissue, and there are many elastic fibers and collagenous fibres, has elasticity and toughness.
Corium is thicker than epidermis, there is blood vessel and nerve abundant.There is subcutaneous tissue below skin, belongs to loose connective tissue, there is significant quantities of fat
Cell.Skin can protect in-vivo tissue to damage from the external world；Progress metabolism is such as absorbed, is perspired, sebum secreted and row are rushed down
Waste etc.；Skin is also adjustable body temperature, the stimulations such as impression pain, touching, pressure, and has immunization.Natural life individual is inevitable
Ground will receive operation wound after the different wound of various weights, especially wound, natural calamity and illness often caused by.Closely
The illness rate of Nian Lai, various chronic diseases increase year by year, cause associated pressure sore, diabetes, venous leg ulcers,
The skins chronic wound such as residual wound, radiation ulcer, cancerous ulcer also shows high incidence after burn or wound.Chronic wound
Interference of the face agglutination by various factors, with pathogenesis complexity, the course of disease is long, it is multidisciplinary to be related to, treatment difficulty is big, controls
Treat the features such as costly.How high efficiency cleans the important subject for repairing that chronic wound is always medical domain high-effectly
One of.Severe trauma, the surface of a wound covering after large-area burns, orthopedic have become a particularly significant problem.
The debridement of chronic wound is cleaned faces test first in clinical application, removes the foreign matter in open wound, excision
Necrosis, inactivation or the tissue seriously polluted, sew up a wound, can provide the wet environment of wound healing, be allowed to reduce dirt to the greatest extent
Dye even becomes clean wound, the environment for keeping it moderately to moisten under airtightness and semi-hermetic dressing and suitable temperature,
The recovery of the function and form of advantageous injury.It is big with high molecular material two to be broadly divided into tradition for debridement wound dressing at present
Class: traditional dressing change method is mainly after debridement is rinsed using physiological saline cotton gauze flap coverage, and surface of a wound environment is relatively
It is dry, it is also poor to the isolation effect of bacterium intrusion, it is unfavorable for wound healing, and be easy induction wound and be adhered, destroys new raw meat
Bud tissue, sepage ability are limited；In recent years the research for the novel mode of dressing change of chronic ulcer and dressing is also more and more, artificial to close
At high molecular polymer dressing, joined bacteriostatic agent as functional components, though mechanical strength is good, biocompatibility
Difference, imbibition easily reach saturation state, and Wound exudate is easily deposited in wound and causes to infect, and synthesize the price phase of high molecular material
To more expensive.For antiseptic dressing relatively common on the market, general added antibacterials are quaternary ammonium salt and glucose
Sour Chlorhexidine etc., fungicidal spectrum is relatively narrow, abuses in current antibiotic, and superpower bacterium infection danger outburst instantly, is easier in institute
There is the problems such as generation and cross-infection of drug-fast bacteria.
After wound debridement is antibacterial, the problem of chronic wound reparative regeneration encounters, comes one after another.Wound inflammatory reaction is cured
The conjunction stage, it is various generate the factors release (such as platelet derived growth factor, transforming growth factor, epidermal growth factor, at fibre
Dimension Porcine HGF and interleukin-11 etc.) it can promote injury immune response, reinforce cell self-regeneration epidermis agglutination.
But the injury of chronic wound patient, every normal mechanism index are all weakened ability decline, more have cancer patient undergoing radiotherapy due to
The mutation for being caused certain DNA to generate irreversibilities by radiation exposure when treating causes permanent disability, thus how the external topical application of drug
Outside applies or stimulates the generation of the various factors, and it is popular to also become a big research clinical research.Lot of experiments shows
Mesenchymal stem cells (mesenchymal stem cells, MSC) have epidermal cell differentiation potential, can promote being cured for the skin that is wound
It closes.They have self-renewing, tissue repair, adjust immune ability, and can be to other spectrums such as epidermal cell, blood vessel endothelium
Confluent monolayer cells differentiation；And cell is easy to expand in vitro, has relatively stable differentiation capability and proliferative capacity after amplification, is suitble to
Large scale preparation.MSCs is coated with self MSCs suspension in the surface of a wound of the patient of deep burn by clinical application in sufferer at present,
It can promote the new life of skin regeneration and blood vessel.The growth factor of industrially prepared stem cell secretion is widely present in human skin
Into the cell, the bioactivity of these small molecular proteins is larger by different external environment influences, and to heat and acid-sensitive, property is not
Stablize, be easy by enzyme hydrolysis, half-life period is very short in vivo, and bioavilability is low when whole body is applied.Function as wound dressing
When additive, curative effect is usually barely satisfactory due to its lower bioavilability.
It can be seen from the above, the skin repair healing whole process of chronic wound is along with more complicated pathophysiological change.Most
Ideal skin wound repair function dressing should have the property that no antigen, a wider spectrum antibacterial ability, preferable soft
Toughness provides Moist healing environment, can induce autologous skin regeneration, is easy to save that drug effect is permanent, cost performance is high.It is cured in conjunction with wound
Conjunction process, if broad-spectrum antibacterial ingredient and rush can be cured the factor is incorporated into same system, it is believed that can meet and improve the first of curative effect
Inner feelings.The one kind of nano silver as nanotechnology has great specific surface area, small-size effect and quantum size effect, simultaneously
Have the advantages that broad spectrum antibacterial and bacterium have no drug resistance to it, the antibacterial activity for having other materials incomparable, and it is right
Some fungies, virus etc. also have stronger killing effect, and do not generate drug resistance, can be used for a long time, and numerous zooperies and face
Bed is research shows that its physicochemical property safety and stability, has no adverse effects to human body.Chitosan (CTS) is a kind of alkaline polysaccharide, can be incited somebody to action
Blood platelet in blood is separated, to promote blood clotting, therefore can be used as hemostat；With antibacterial, promote to be cured, stop blooding etc.
Feature；Alginic acid is a kind of natural polyanions polysaccharide, wherein most commonly seen is alginic acid sodium salt, sodium alginate has preferable
Biocompatibility, with environment liquid without interfacial tension.The hydration for being conducive to tissue in the debridement phase accelerates the dissolution of necrotic tissue
And it absorbs；The phase is formed in granulation tissue, the release of various growth factors is can promote, stimulates the regeneration of capillary；In epithelium
The change phase, the speed that epidermal cell migrates in wet environment is accelerated, and has the function of repairing corium rapidly.Pass through electrostatic interaction
Chitin-sodium alginate slow-release microcapsule made of crosslinking substantially strengthens the mechanical strength and densification of hydrogel from material
Property, drug and extraneous environment can be isolated, reduce the adverse effects of the environmental factors to object is contained such as acid and protease, keep containing
The activity of object improves the bioavilability and stability of drug, enhances its slow releasing function.The present invention selects chitin-alginic acid
Sodium loads epidermal growth factor (EGF), fibroblast growth factor (FGF), vascular endothelial growth factor as spansule
(VEGF) etc., these bioactie agents can quickly activate the skin adult stem cell of suspend mode and promote its growth, while can
To adjust microenvironment in body, advantageous growth conditions is provided for Skin Cell.Outer layer attached nanofiber silver bacteria inhibiting composition is used as
It is antibacterial that the first floor acts on debridement.The synergistic effect of these matrix, nanosecond science and technology material and all kinds of factors greatly improves induction wound
The ability of face healing.
Summary of the invention
The present invention proposes a kind of loading nano silvery and medical dressing of bioactie agent and preparation method thereof.The dressing
Be using calcium alginate, chitosan or chitosan derivatives as matrix, loading nano silvery bacteria inhibiting composition particle and bioactivity because
Son etc. is prepared.In preparation to calcium chloride solution dropwise addition be mixed in the sodium alginate soln of growth factor obtain package growth because
The calcium alginate core microballoon of son.Microballoon is added to chitosan-acetic acid solution and forms compound polyelectrolyte.Again by poly- electrolysis
Matter compound and nano silver, chitosan are mixed, and are added in sodium alginate and are crosslinked, are freeze-dried, ultimately form negative
The chronic wound dressing of carrying nano silver and growth factor.The method of the present invention raw material is cheap and easy to get, preparation process is stablized, chronic wound
Dressing bacteriostasis property is good, and wound repair ability is excellent, for all kinds of slow caused by cancer radiation therapy and diabetes, ischemic etc.
Property the surface of a wound treatment, induction the surface of a wound cleaning repair.
In order to solve the above technical problems, the technical scheme is that
A kind of medical dressing of loading nano silvery and bioactie agent, the medical dressing include nano material, matrix and
Bioactie agent is mixed by proper proportion, is applied on medical non-woven fabrics, is transferred to press seal on medical adhesive tape and is prepared.
The nano material is nano-silver bacteriostatic composition particle, and averagely using concentration is 30ppm.
The matrix is chitosan and its derivative and sodium alginate, is mixed in a certain ratio, wherein chitosan spreads out
Biology selects carboxymethyl chitosan, hydroxypropyl chitosan or chitosan quaternary ammonium salt one such.
The matrix configuration method, chitosan be dissolved in the acetum that mass fraction is 1.0% be configured to 1%~
The chitosan solution of 2.5% (W/V), is then added 1%~4% (W/V) CaCl2 solution, and stirring and dissolving obtains chitosan chlorination
Calcium mixed solution；The sodium alginate soln of 1%~2.5% (W/V) is prepared, it is poly- to form shell for filtration washing after at the uniform velocity stirring 30min
Sugar is 1:2~2:1 with calcium alginate mass ratio, wherein chitosan can be replaced with chitosan derivatives.
The bioactie agent be one or more of cells of embryonic stem cell or adult stem cell during the cultivation process
Secretion contains epidermal growth factor (EGF), fibroblast growth factor (FGF), platelet derived growth factor (PDGF), blood vessel
The multiple effective components such as endothelial growth factors (VEGF), transforming growth factor (TGF).
Derived from embryonic stem cells is in human or animal；Adult stem cell is the cord blood stem cell from human or animal, sheep
Water stem cell, peripheral blood hematopoietic stem cells, mesenchymal stem cell one or more.
Medical non-woven fabrics needs to carry out immersion 12h with 1%~2.5% sodium alginate soln before use.
The mixed method of bioactie agent, matrix and nano material, the growth factor for taking logarithmic phase to secrete, with 1:1's
Ratio is dissolved in sodium alginate soln, obtains the compound polyelectrolyte that bioactie agent concentration is 200ug/g~400ug/g
Be embedded in sodium alginate chitosan microball, then with the nano-silver bacteriostatic composition particle of 30ppm, 1%~2.5% (W/V)
Chitosan solution obtains mixed liquor after mixing evenly.
The hybrid reaction is in pH=7.0, and temperature carries out under the conditions of being 37 DEG C, Percentage bound highest under this environment.
The mixed liquor is uniformly applied on the medical non-woven fabrics handled well, passes through the method for ambient self-crosslinking 30min
Obtain growth factor-loaded and nano-Ag particles water-setting adhesive plasters.
The medical adhesive tape is the PU membrane adhesive tape with pressure sensitive adhesive, will be medical not with the non-woven fabrics of hydrogel crosslinking and PU film
Pressure sensitive adhesive adhesion on adhesive tape, barrier paper cover hydrogel, have obtained the medical dressing of loading nano silvery and growth factor.
A kind of medical dressing preparation method of loading nano silvery and bioactie agent, step:
A. the preparation of matrix: chitosan is dissolved in the acetum that mass fraction is 1.0% and is configured to 1%~2.5%
(W/V) chitosan solution, is then added 1%~4% (W/V) CaCl2 solution, and it is mixed to obtain chitosan calcium chloride for stirring and dissolving
Close solution；Prepare 1%~2.5% (W/V) sodium alginate soln, at the uniform velocity stirring 30min after filtration washing formed chitosan with
Calcium alginate mass ratio is 1:2~2:1, wherein chitosan can also be replaced with chitosan derivatives；
B. the preparation of stem cell factor: using the DMEM culture medium (complete medium) for containing 10% fetal calf serum, in
37 DEG C, routine culture is carried out to stem cell under conditions of 5%CO2, reach 90% or so, cell concentration to cell fusion degree and reach
When 1~10 × 106, the culture solution containing stem cell factor is drawn, is centrifuged, after abandoning precipitating takes supernatant to be freeze-dried
It is spare；
C., the growth activity factor is dissolved in wherein to obtain the sodium alginate containing bioactie agent molten with the ratio of 1:1
Liquid.The sodium alginate soln that certain EGF is extracted using 10ml syringe is added drop-wise in above-mentioned chitosan calcium chloride mixed solution,
The concentration of bioactie agent is the compound polyelectrolyte of 200ug/g~400ug/g --- the sea of embedding bioactie agent
Mosanom chitosan core microballoon；
D. by the nano silver antibacterial group of the obtained growth factor-loaded sodium alginate chitosan core microballoon and 30ppm of c
Polymer beads, 1%~2.5% chitosan solution obtain mixed liquor after mixing evenly；
E. after carrying out immersion 12h to medical non-woven fabrics with the sodium alginate soln of 1%~2.5% (W/V), by above-mentioned mixing
Liquid is uniformly applied on the non-woven fabrics handled well, and ambient self-crosslinking 30min forms load epithelical cell growth factor EGF and nanometer
The water-setting adhesive plaster of silver-colored bacteria inhibiting composition particle；
F. the water-setting adhesive plaster for loading epithelical cell growth factor EGF and nano-silver bacteriostatic composition particle is transferred to pressure
On the PU film medical adhesive tape of quick glue, by with hydrogel crosslinking non-woven fabrics and PU film medical adhesive tape on pressure sensitive adhesive adhesion, every
Hydrogel is covered from paper, has obtained loading nano silvery and the chronic wound dressing of epithelical cell growth factor EGF；
G. by the handy 20kGy dosage 60Co irradiation sterilization of e step institute.
It is compared with existing technology, the invention has the benefit that present invention employs alginate and chitosan etc. are more
Kind biocompatibility natural polymer prepares chronic wound and applies as matrix, loading nano silvery particle and epidermal growth factor EGF
The disadvantages of material, the present invention solve existing dressing poor biocompatibility, and bacteriostasis antibiosis performance is weak, drug effect is single, imbibition ability is poor,
Fill up that the dressing domain set surface of a wound is antibacterial and epidermal growth reparation is in the blank of one.The method of the present invention raw material is cheap and easy to get, grasps
Make that mild condition, operating procedure are simple, process is stable, chronic wound dressing bacteriostasis property is good, and wound repair ability is excellent, can
Applied in the treatment of various chronic wounds caused by cancer radiation therapy and diabetes, ischemic etc..
Detailed description of the invention
Attached drawing 1 prepares chronic wound dressing for loading nano silvery particle and epidermal growth factor EGF obtained in embodiment 1
Structure chart；
Attached drawing 2 is 5 nano silvers of embodiment/epithelical cell growth factor EGF/ carboxymethyl chitosan/chronic wound of sodium alginate
Face dressing anti-microbial property bacterium colony figure；
Nano silver/epithelical cell growth factor EGF/ carboxymethyl chitosan/seaweed is used when attached drawing 3 is in Application Example
Observation in sour sodium chronic wound dressing the 3rd day and record wound healing situation map；
Nano silver/epithelical cell growth factor EGF/ carboxymethyl chitosan/seaweed is used when attached drawing 4 is in Application Example
Observation in sour sodium chronic wound dressing the 14th day and record wound healing situation map；
Fig. 5 is Xi Er Lingshui Spring gel dressing and commonly surface of a wound microbial flora changes ratio after being used 10 days with medical accessory
Compared with figure；
Fig. 6 be Xi Er Lingshui Spring gel dressing and commonly with medical accessory using surface of a wound microbial flora type after 10 days and
Abundance compares figure.
Note: X group is Xi Er Lingshui Spring gel dressing group, and the common medical dressing group of Y group
Specific embodiment
Below in conjunction with specific embodiment, the present invention will be further described.
Embodiment 1
Nano silver/epidermal growth factor EGF/ chitosan/sodium alginate chronic wound dressing preparation:
A. first chitosan be dissolved in mass fraction be 1.0% acetum be configured to 1.5% (W/V) chitosan it is molten
Liquid, is then added 3%CaCl2 (W/V) solution, and stirring and dissolving obtains chitosan calcium chloride mixed solution；Prepare 2.5% (W/V)
Sodium alginate soln, epithelical cell growth factor EGF is dissolved in the ratio of 1:1 and wherein obtains the sodium alginate containing EGF
Solution；
B. the preparation of stem cell factor: using the DMEM culture medium (complete medium) for containing 10% fetal calf serum, in
37 DEG C, routine culture is carried out to stem cell under conditions of 5%CO2, reach 90% or so, cell concentration to cell fusion degree and reach
1~10 × 106When, the culture solution containing stem cell factor is drawn, is centrifuged, after abandoning precipitating takes supernatant to be freeze-dried
It is spare；
C. the sodium alginate soln that certain EGF is extracted using 10ml syringe is added drop-wise to above-mentioned chitosan calcium chloride mixing
In solution, filtration washing forms chitosan after at the uniform velocity stirring 30min and calcium alginate mass ratio is 2:1, epidermal growth factor
The concentration of EGF is the compound polyelectrolyte of 200ug/g --- the sodium alginate chitosan core microballoon of embedding EGF；
D. carry EGF sodium alginate chitosan core microballoon and 30ppm nano-Ag particles, 1.5% chitosan solution
Mixed liquor is obtained after mixing evenly；
E. after carrying out immersion 12h to medical non-woven fabrics with the sodium alginate soln of 2.5% (W/V), above-mentioned mixed liquor is equal
Even to be applied on the non-woven fabrics handled well, ambient self-crosslinking 30min forms load epidermal growth factor EGF and nano silver antibacterial
The water-setting adhesive plaster of composition grain；
F. the water-setting adhesive plaster for loading epidermal growth factor EGF and nano-silver bacteriostatic composition particle is transferred to band pressure sensitive adhesive
PU film medical adhesive tape on, by with hydrogel crosslinking non-woven fabrics and PU film medical adhesive tape on pressure sensitive adhesive adhesion, barrier paper
Hydrogel is covered, loading nano silvery and the chronic wound dressing of epithelical cell growth factor EGF have been obtained；
G. by the handy 20kGy dosage 60Co irradiation sterilization of f step institute.
Embodiment 2
Nano silver/epidermal growth factor EGF/ carboxymethyl chitosan/sodium alginate chronic wound dressing preparation:
A. carboxymethyl chitosan is dissolved in the acetum that mass fraction is 1.0% and is configured to 1.5% (W/V's) first
Carboxymethyl chitosan solution, is then added 3%CaCl2 (W/V) solution, and it is mixed to obtain carboxymethyl chitosan calcium chloride for stirring and dissolving
Close solution；The sodium alginate soln for preparing 2.5% (W/V), epidermal growth factor EGF is dissolved in the ratio of 1:1 and is wherein obtained
Sodium alginate soln containing EGF；
B. the preparation of stem cell factor: using the DMEM culture medium (complete medium) for containing 10% fetal calf serum, in
37 DEG C, routine culture is carried out to stem cell under conditions of 5%CO2, reach 90% or so, cell concentration to cell fusion degree and reach
1~10 × 106When, the culture solution containing stem cell factor is drawn, is centrifuged, after abandoning precipitating takes supernatant to be freeze-dried
It is spare；
C. the sodium alginate soln that certain EGF is extracted using 10ml syringe is added drop-wise to above-mentioned carboxymethyl chitosan chlorination
In calcium mixed solution, filtration washing forms carboxymethyl chitosan after at the uniform velocity stirring 30min and calcium alginate mass ratio is 2:1, table
The concentration of skin growth factor EGF is the compound polyelectrolyte of 200ug/g --- the sodium alginate carboxymethyl chitosan of embedding EGF
Core microballoon；
D. carry the sodium alginate carboxymethyl chitosan core microballoon of EGF and the nano-Ag particles of 30ppm, 1.5% shell it is poly-
Sugar juice obtains mixed liquor after mixing evenly；
E. after carrying out immersion 12h to medical non-woven fabrics with the sodium alginate soln of 2.5% (W/V), above-mentioned mixed liquor is equal
Even to be applied on the non-woven fabrics handled well, ambient self-crosslinking 30min forms load epidermal growth factor EGF and nano silver antibacterial
The water-setting adhesive plaster of composition grain；
F. the water-setting adhesive plaster for loading epidermal growth factor EGF and nano-silver bacteriostatic composition particle is transferred to band pressure sensitive adhesive
PU film medical adhesive tape on, by with hydrogel crosslinking non-woven fabrics and PU film medical adhesive tape on pressure sensitive adhesive adhesion, barrier paper
Hydrogel is covered, loading nano silvery and the chronic wound dressing of epithelical cell growth factor EGF have been obtained；
G. by the handy 20kGy dosage 60Co irradiation sterilization of f step institute.
Embodiment 3
Nano silver/epidermal growth factor EGF/ carboxylic propyl chitosan/sodium alginate chronic wound dressing preparation:
A. carboxylic propyl chitosan is dissolved in the acetum that mass fraction is 1.0% and is configured to 1.5% (W/V's) first
Carboxylic propyl chitosan solution, is then added 3%CaCl2 (W/V) solution, and it is mixed to obtain carboxylic propyl chitosan calcium chloride for stirring and dissolving
Close solution；The sodium alginate soln for preparing 2.5% (W/V), epidermal growth factor EGF is dissolved in the ratio of 1:1 and is wherein obtained
Sodium alginate soln containing EGF；
B. the preparation of stem cell factor: using the DMEM culture medium (complete medium) for containing 10% fetal calf serum, in
37 DEG C, routine culture is carried out to stem cell under conditions of 5%CO2, reach 90% or so, cell concentration to cell fusion degree and reach
1~10 × 106When, the culture solution containing stem cell factor is drawn, is centrifuged, after abandoning precipitating takes supernatant to be freeze-dried
It is spare；
C. the sodium alginate soln that certain EGF is extracted using 10ml syringe is added drop-wise to above-mentioned carboxylic propyl chitosan chlorination
In calcium mixed solution, filtration washing forms carboxylic propyl chitosan after at the uniform velocity stirring 30min and calcium alginate mass ratio is 2:1, table
The concentration of skin growth factor EGF is the compound polyelectrolyte of 200ug/g --- the sodium alginate carboxylic propyl chitosan of embedding EGF
Core microballoon；
D. carry EGF sodium alginate carboxylic propyl chitosan core microballoon and 30ppm nano-Ag particles, 1.5% carboxylic third
Base chitosan solution obtains mixed liquor after mixing evenly；
E. after carrying out immersion 12h to medical non-woven fabrics with the sodium alginate soln of 2.5% (W/V), above-mentioned mixed liquor is equal
Even to be applied on the non-woven fabrics handled well, ambient self-crosslinking 30min forms load epidermal growth factor EGF and nano silver antibacterial
The water-setting adhesive plaster of composition grain；
F. the water-setting adhesive plaster for loading epidermal growth factor EGF and nano-silver bacteriostatic composition particle is transferred to band pressure sensitive adhesive
PU film medical adhesive tape on, by with hydrogel crosslinking non-woven fabrics and PU film medical adhesive tape on pressure sensitive adhesive adhesion, barrier paper
Hydrogel is covered, loading nano silvery and the chronic wound dressing of epithelical cell growth factor EGF have been obtained；
G. by the handy 20kGy dosage 60Co irradiation sterilization of f step institute.
Embodiment 4
Nano silver/epidermal growth factor EGF/ chitosan quaternary ammonium salt/sodium alginate chronic wound dressing preparation:
A. chitosan quaternary ammonium salt is dissolved in the acetum that mass fraction is 1.0% and is configured to 1.5% (W/V's) first
Chitosan quaternary ammonium salting liquid, is then added 3%CaCl2 (W/V) solution, and it is mixed to obtain chitosan quaternary ammonium salt calcium chloride for stirring and dissolving
Close solution；The sodium alginate soln for preparing 2.5% (W/V), epidermal growth factor EGF is dissolved in the ratio of 1:1 and is wherein obtained
Sodium alginate soln containing EGF；
B. the preparation of stem cell factor: using the DMEM culture medium (complete medium) for containing 10% fetal calf serum, in
37 DEG C, routine culture is carried out to stem cell under conditions of 5%CO2, reach 90% or so, cell concentration to cell fusion degree and reach
1~10 × 106When, the culture solution containing stem cell factor is drawn, is centrifuged, after abandoning precipitating takes supernatant to be freeze-dried
It is spare；
C. the sodium alginate soln that certain EGF is extracted using 10ml syringe is added drop-wise to above-mentioned chitosan quaternary ammonium salt chlorination
In calcium mixed solution, filtration washing forms chitosan quaternary ammonium salt after at the uniform velocity stirring 30min and calcium alginate mass ratio is 2:1, table
The concentration of skin growth factor EGF is the compound polyelectrolyte of 200ug/g --- the sodium alginate chitosan quaternary ammonium salt of embedding EGF
Core microballoon；
D. carry the sodium alginate chitosan quaternary ammonium salt core microballoon of EGF and the nano-Ag particles of 30ppm, 1.5% shell it is poly-
Sugared quaternary ammonium salt solution obtains mixed liquor after mixing evenly；
E. after carrying out immersion 12h to medical non-woven fabrics with the sodium alginate soln of 2.5% (W/V), above-mentioned mixed liquor is equal
Even to be applied on the non-woven fabrics handled well, ambient self-crosslinking 30min forms load epidermal growth factor EGF and nano silver antibacterial
The water-setting adhesive plaster of composition grain；
F. the water-setting adhesive plaster for loading epidermal growth factor EGF and nano-silver bacteriostatic composition particle is transferred to band pressure sensitive adhesive
PU film medical adhesive tape on, by with hydrogel crosslinking non-woven fabrics and PU film medical adhesive tape on pressure sensitive adhesive adhesion, barrier paper
Hydrogel is covered, loading nano silvery and the chronic wound dressing of epithelical cell growth factor EGF have been obtained；
G. by the handy 20kGy dosage 60Co irradiation sterilization of f step institute.
Embodiment 5
Nano silver/epidermal growth factor EGF/ carboxymethyl chitosan/sodium alginate chronic wound dressing performance test-is anti-
The antibacterial test of bacterium
Respectively in five culture dishes 100 microlitres of even spread 105-106Cfu/ml golden yellow staphylococcus, large intestine angstrom are uncommon
Bacterium, bacillus subtilis, pseudomonas aeruginosa, Candida albicans, loading nano silvery and epidermis obtained in embodiment 2 is raw
The disk that the slow wound dressing of the long factor is cut into diameter 10mm is put into culture dish, cultivated at 37 DEG C 24 hours observation bacteriums whether there is or not
Bacterium colony generates (attached drawing 2), then does identical parallel laboratory test twice and verified, prepared by the example 1 of this implementation according to the experimental results
Chronic wound dressing work well.
Note: √ indicates that bacterium colony is formed, × indicate that no bacterium colony is formed
Embodiment 6
Nano silver/epidermal growth factor EGF/ carboxymethyl chitosan/sodium alginate chronic wound dressing performance test-suction
Wet performance test
It is modified slightly with reference to People's Republic of China (PRC) pharmaceuticals industry standard YY/T0471.2-2004 and carries out moisture-vapor transmission
Test.Make the salable test container that a Circularhole diameter is 1cm, add water to the water surface between hydrogel sample at a distance from for 5
± 1mm, hydrogel sample is covered in the concave edge of test container, clamps sample, and sample is avoided to generate deformation.It weighs afterwards for 24 hours
And the gross mass (W1) of container, sample and liquid is recorded, it is put into 37 DEG C of constant incubators, sample is upward.To container after 72h
Sample and liquid weigh again, record quality (W2), every kind sample test 5 times, weigh the time accurately in 5min, take it flat
Mean value.Using formula W T=(W1-W2)/T × 10000 × 4 carry out that moisture-vapor transmission is calculated.
0.5g aerogel dressing is immersed in 37 DEG C of PBS buffer solution and carries out water absorption and swelling, taken out after 120min molten
Gel after swollen, after the moisture that excess surface is sucked with filter paper, weighing.The swelling ratio (SR) of t moment hydrogel is calculated as follows:
SR=(Wt-W0)/W0× 100%
In formula, SR is the swelling ratio of hydrogel；WtFor the quality g of wet gel after swelling；W0For the matter for being swollen preceding xerogel
Amount.
Application Example 1
Nano silver/epithelical cell growth factor EGF/ chitosan/sodium alginate chronic wound dressing clinical application
1. case selection
It has been controlled in institute's surface of a wound through various in First Affiliated Hospital Of Nanchang University 20~60 years old since selection 2018~2019 years
The chronic wound Patients with 300 Cases more or in two or three months not healed completely carries out clinical observation, chronic wound within treatment 1 month or more
Type includes diabetes, II degree of burn and scald, bedsore, the cancer radiation therapy surface of a wound, traumatic ulcer.Patient is randomly divided into treatment
Group and two groups of control group, treatment group 150, control group 150, the age of two groups of cases for the treatment of group and control group, gender wound
Type and wound rank random distribution.
2. therapeutic scheme
Treatment group patient uses nano silver/epithelical cell growth factor EGF/ carboxylic first obtained in example 2 in the present invention
Base enclosure glycan/sodium alginate chronic wound dressing through the surface of a wound thoroughly it is pure and fresh after, stick this dressing in chronic wound, change within every 3 days
Medicine is primary；Mentor Corp., control group Denmark produces the dressing of alginates silver, and every dressing in 3 days is primary.It continuous dressing 21 days, is seeing
Examine the efficacy situation of experimental group and two groups of control group；The the 3rd, 5,7,14,21 day observe and record wound healing situation and
Speed (attached drawing 3, attached drawing 4).The diet of strict control patient during treating.
3. observation index
1) curative effect determinate standard
It is formulated referring to the guideline of clinical investigations of " Chinese Clinical rehabilitation ":
Cure: the surface of a wound heals completely, only stays pigmentation and scar person.
Effective: 70% or more skin lesion healing, remaining is glossy or dry table fester.
Effective: skin lesion healing 40%-70%, remaining epidermis or corium all lack, wound visible dermis adipose tissue, but
Not yet penetrate bone, tendon or muscle layer.
Invalid: 30% or less skin lesion healing adds severe one, full epidermis missing, including exposed bone, tendon or muscle,
Slough or eschar often have the presence moved under water with sinus.
2) surface of a wound bacterium picking out rate: judging whether there is infection depending on surface of a wound situation over the course for the treatment of, and 3 after wound, 5,7,
14,21d is respectively to 3 groups of carry out wound secretion Bacteria Cultures and identification
3) each time point Wound healing rate
Calculation formula are as follows: Wound healing rate=(surface of a wound original area-surface of a wound residual area)/surface of a wound original area ×
100%.For the original surface of a wound and residual wound, the method for drawing surface of a wound shape with transparent graph paper, using Adobe
Photoshop7.0 and Osiris software carries out areal calculation.
4) adverse drug reaction: record local stimulation, allergic reaction.
5) surface of a wound microbial load changes: micro- after different dressing treatments using the microorganism genome sequencing analysis surface of a wound
The variation of bioburden, type and abundance.
4. statistical method
Using SPSS18.0 system software statistic data；Wherein measurement data is usedIt indicates, and is examined with t
It tests；Enumeration data is indicated with [n (%)], and uses χ2It examines, indicates that difference is statistically significant with P < 0.05.
5. interpretation of result
5.1 treatment groups and control group curative effect compare,
The effective percentage for the treatment of group is 97.3%, and the effective percentage of control group is 86%, and two groups of the efficient for the treatment of compare, difference
Statistically significant (P < 0.05), is shown in Table 1.
1 treatment group of table and control group curative effect compare
5.2 treatment groups and the comparison of control group surface of a wound bacterium picking out rate
The bacterium picking out rate for the treatment of group is obviously significantly lower than control group, and difference is statistically significant (P < 0.05), is shown in Table 2
2 treatment group of table and control group surface of a wound bacterium picking out rate (%)
| Group | Number of cases | Positive [%/(n/n)] |
| Treatment group | 150 | 7.3% (11/150) |
| Control group | 150 | 21.3% (32/150) |
The comparison of 5.3 treatment groups and control group different time points Wound healing rate
Treatment group's healing rate is compared with control group height, and healing rate has significant (P < 0.05) compared to difference after 14d, sees
Table 3.
The comparison of 3 treatment group of table and control group different time points Wound healing rate (%)
5.4 adverse drug reactions:
For the control group surface of a wound without allergic reaction, there is local burn feeling after having 1 patient with diabetic feet dressing in treatment group,
Symptom is voluntarily alleviated after 20min.
5.5 surface of a wound Tiny ecosystem Flora dynamics:
The analysis of microorganism genome sequencing (NGS) display is carried out to the surface of a wound, after treatment 10 days, control group surface of a wound microorganism
Carrying capacity is significantly higher than Xi Er Lingshui Spring gel dressing treatment group (Fig. 5), and shows to microbe species and enrichment analysis, Xi Er Lingshui Spring
The microbe species and abundance of the gel dressing treatment group surface of a wound are significantly higher than control group (Fig. 6), show Xi Er Lingshui Spring gel dressing
Can significantly reduce the microbial load of the surface of a wound, and by increase microbe species and abundance fight single pathogen infection and
Invasion facilitate the quick healing and recovery of the surface of a wound.
Claims (12)
1. the medical dressing of a kind of loading nano silvery and bioactie agent, it is characterised in that: the medical dressing includes nanometer material
Material, matrix and bioactie agent are mixed by proper proportion, are applied on medical non-woven fabrics, are transferred to press seal on medical adhesive tape
It is prepared.
2. the medical dressing of loading nano silvery and bioactie agent according to claim 1, it is characterised in that: described receives
Rice material is nano-silver bacteriostatic composition particle, and averagely using concentration is 30ppm.
3. the medical dressing of loading nano silvery and bioactie agent according to claim 1, it is characterised in that: the matrix
It for chitosan and its derivative and sodium alginate, is mixed in a certain ratio, wherein chitosan derivatives select carboxymethyl shell
Glycan, hydroxypropyl chitosan or chitosan quaternary ammonium salt are one such.
4. the medical dressing of loading nano silvery and bioactie agent according to claim 3, it is characterised in that: the matrix
Configuration method, chitosan be dissolved in mass fraction be 1.0% acetum be configured to 1%~2.5%(W/V) chitosan solution,
Then 1%~4%(W/V is added) CaCl2Solution, stirring and dissolving obtain chitosan calcium chloride mixed solution；Prepare 1%~2.5%
(W/V) sodium alginate soln, after at the uniform velocity stirring 30min filtration washing formed chitosan and calcium alginate mass ratio be 1:2~
2:1, wherein chitosan can be replaced with chitosan derivatives.
5. the medical dressing of loading nano silvery and bioactie agent according to claim 1, it is characterised in that: the biology
Active factors contain epidermal growth for what one or more of cells of embryonic stem cell or adult stem cell were secreted during the cultivation process
The factor (EGF), fibroblast growth factor (FGF), platelet derived growth factor (PDGF), vascular endothelial growth factor
(VEGF), transforming growth factor (TGF).
6. the medical dressing of loading nano silvery and bioactie agent according to claim 5, it is characterised in that: embryo is dry thin
Born of the same parents derive from human or animal；Adult stem cell is made for the cord blood stem cell, amniotic fluid stem cell, peripheral blood from human or animal
Hemocytoblast, mesenchymal stem cell one or more.
7. the medical dressing of loading nano silvery and bioactie agent according to claim 1, it is characterised in that: medical non-woven
Cloth needs to carry out immersion 12h with 1%~2.5% sodium alginate soln before use.
8. the medical dressing of loading nano silvery and bioactie agent according to claim 1, it is characterised in that: bioactivity
The mixed method of the factor, matrix and nano material, the growth factor for taking logarithmic phase to secrete, is dissolved in sodium alginate with the ratio of 1:1
Solution, obtaining the compound polyelectrolyte that bioactie agent concentration is 200ug/g~400ug/g, to be embedded in sodium alginate shell poly-
In sugared microballoon, then nano-silver bacteriostatic composition particle, 1%~2.5%(W/V with 30ppm) chitosan solution after mixing evenly
Obtain mixed liquor.
9. the medical dressing of loading nano silvery and bioactie agent according to claim 8, it is characterised in that: the mixing
Reaction is in pH=7.0, and temperature carries out under the conditions of being 37 DEG C, Percentage bound highest under this environment.
10. the medical dressing of loading nano silvery and bioactie agent according to claim 8, it is characterised in that: described
Mixed liquor is uniformly applied on the medical non-woven fabrics handled well, by the method for ambient self-crosslinking 30min obtain load growth because
The water-setting adhesive plaster of son and nano-Ag particles.
11. the medical dressing of loading nano silvery and bioactie agent according to claim 1, it is characterised in that: described
Medical adhesive tape is the PU membrane adhesive tape with pressure sensitive adhesive, by the pressure sensitive adhesive on the non-woven fabrics and PU film medical adhesive tape that are not crosslinked with hydrogel
Adhesion, barrier paper cover hydrogel, have obtained the medical dressing of loading nano silvery and growth factor.
12. the medical dressing preparation method of a kind of loading nano silvery and bioactie agent, step:
A. the preparation of matrix: chitosan be dissolved in mass fraction be 1.0% acetum be configured to 1%~2.5%(W/V) shell
Then 1%~4%(W/V is added in glycan solution) CaCl2 solution, stirring and dissolving obtains chitosan calcium chloride mixed solution；It prepares
1%~2.5%(W/V) sodium alginate soln, filtration washing forms chitosan and calcium alginate mass ratio after at the uniform velocity stirring 30min
For 1:2~2:1, wherein chitosan can also be replaced with chitosan derivatives；
B. the preparation of stem cell factor: using contain 10% fetal calf serum DMEM culture medium (complete medium), in 37 DEG C,
Routine culture is carried out to stem cell under conditions of 5%CO2, reaches 90% or so, cell concentration to cell fusion degree and reaches 1~10
When × 106, the culture solution containing stem cell factor is drawn, is centrifuged, abandoned precipitating and take supernatant freeze-dried back；
C. the growth activity factor is dissolved in the ratio of 1:1 and wherein obtains the sodium alginate soln containing bioactie agent；Benefit
The sodium alginate soln that certain EGF is extracted with 10ml syringe is added drop-wise in above-mentioned chitosan calcium chloride mixed solution, biology
The concentration of active factors is the compound polyelectrolyte of 200ug/g~400ug/g --- the alginic acid of embedding bioactie agent
Sodium chitosan core microballoon；
D. by the nano-silver bacteriostatic composition of obtained growth factor-loaded sodium alginate the chitosan core microballoon and 30ppm of c
Particle, 1%~2.5% chitosan solution obtain mixed liquor after mixing evenly；
E. after carrying out immersion 12h to medical non-woven fabrics with the sodium alginate soln of 1%~2.5% (W/V), above-mentioned mixed liquor is uniform
It is applied on the non-woven fabrics handled well, ambient self-crosslinking 30min forms load epithelical cell growth factor EGF and nano silver antibacterial
The water-setting adhesive plaster of composition grain；
F. the water-setting adhesive plaster for loading epithelical cell growth factor EGF and nano-silver bacteriostatic composition particle is transferred to band pressure sensitive adhesive
PU film medical adhesive tape on, by with hydrogel crosslinking non-woven fabrics and PU film medical adhesive tape on pressure sensitive adhesive adhesion, barrier paper
Hydrogel is covered, loading nano silvery and the chronic wound dressing of epithelical cell growth factor EGF have been obtained；
G. by the handy 20kGy dosage 60Co irradiation sterilization of e step institute.
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| CN116549712B (en) * | 2023-04-23 | 2024-04-02 | 清泽医疗科技(广东)有限公司 | Degradable healing-promoting medical adhesive and preparation method thereof |
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