Hydrogel eye protection sticking dressing and preparation method thereof
Technical field
The invention belongs to medical wound dressing and its preparation field, more particularly to a kind of being applied to stick general anesthesia operation disease
Outside the eye of people or depth coma patient, relatively closed wet environment is provided to patient, prevent the water-setting of exposure keratitises
Glue eye protection sticking dressing and preparation method thereof.
Background technology
Exposure keratitises refer to cornea lose eyelid protection expose in atmosphere, cause be dried, exuviation and after
The Corneal inflammation of infection is sent out, severe patient can cause corneal ulcer.Be embodied in ocular photophobia, shed tears, foreign body sensation and regard thing
It is fuzzy, a certain degree of pain is brought to patient.Research shows exposure keratitises occur in 70% patient with general anesthesia art
Ratio be up to 40%~60%, therefore general anesthesia in the prevention of exposure keratitises should cause enough attention.
Therapeutic Method substantially has three kinds at present:One is normal saline gauze cladding process, i.e., the little yarn for being soaked with normal saline
Cloth covers its eyes, to provide moist environment.But gauze is easily dried, action time is short(20-30 minutes), frequently need to change, greatly
The workload of medical personnel is increased greatly, and saline easily enters eye, discomfort is caused to patient;Two is Drug therapy, mainly
Antibiotic Eye Ointment is smeared, so as to play prophylactic action.But which need to defer to the operation of standardization coating, and medicine itself has slightly
The untoward reaction symptom such as excitement, anaphylaxiss, hyperemia, ophthalmic pruritus, edema, which is up to the eye of 8h not after can also causing anesthesia
It is suitable, such as viscid sense of furious, blurred vision, eye etc..Three is using hydrogel eye paste, because which can closely be covered on the outer of eye
Portion, can play a part of physical isolation in whole operation process, cover to eye, can make eye again in relatively closed
Moist environment, with moistening cornea, prevents effect of exposure keratitises.
It is published on July 8th, 2009《A kind of special hydrogel eye plaster of patient with general anesthesia》(CN101474169A)
Disclose a kind of emplastrum hydrogel eye pad pasting with crosslinking or partial cross-linked water-soluble high-molecular compound as substrate.Announce
In on December 28th, 2011《The preparation technology and purposes of a kind of protector》(CN102293697A)Disclose it is a kind of by
Hold the eye protector of layer, gel layer and sealing coat up of three layers.Eye protector described in two patents of the above is used equally to entirely
Body Anesthetic Patients art patient, can prevent, control the generation of exposure keratitises, protect patient's eye not by foreign object damage, but
There is poor transparency, there is the harmful substances such as cross-linking agent residual.It is published in September in 2009 2 days《Medical moisturized eye
Patch and preparation method thereof》(CN101518481A)Disclose a kind of chilled, solidification of thawing, the medical moisturized shield of irradiated crosslinking
Eye sticker, the moisturized eye paste meet the shape of human body circumference of eyes structure, disposable to operate, and use time is long, can provide relative
Closed wet environment, with transparent, ventilative, waterproof, not with tissue adhesion, with good biocompatibility, with rear without residual
Stay, it is not necessary to clean patient skin and hair;But the technique is chilled, thaw, preparation technology is time-consuming longer, at the same cost of manufacture compared with
It is high.
At present, it is for the defect of tradition prevention exposure keratitises method, various with macromolecule hydrogel layer as main work
Come out one after another with the eye paste of substrate.Hydrogel eye paste has obvious compared with traditional prevention exposure keratitises method
It is progressive, but simple hydrogel is inadequate with the adhesion strength of skin, easily comes off during operation process.If being solidifying entirely inside and outside product
Glue, towards the one side of air, no any covering, operation towel or other articles are tended to stick to above, and by which from eyes
On take away, or make which come off;And be easily adhered on the finger of doctor, it has not been convenient to use;Product does not have complete support layer, machine
Tool intensity is poor.
It is published on March 2nd, 2011《A kind of eye protector》(CN201752452U)One kind is disclosed by supporting layer(Material
Matter is non-woven fabrics or gas permeable polymers film)With coating gel layer in the above, and gel layer another side cover every
Absciss layer(Material is the release paper or glass-film for scribbling silicone)The eye protector of up of three layers.It is published on October 5th, 2011
《A kind of Self-adhesive moisturizing eye patch》(CN201996737U)A kind of Self-adhesive moisturizing eye patch, including eye sticker are disclosed, is high
Molecule hydrogel layer;The annular belt of Design of Reinforcement is provided with around eye sticker, the two ends of belt are provided with overhanging proposition part, interior
Side is coated with medical pressure-sensing glue-line, and one layer of release paper is coated with pressure-sensitive adhesive layer.Eye protector described in two patents of the above
Can effectively solving poor adhesion, no appearance protective layer and supporting layer, mechanicalness it is poor, operation inconvenience the problems such as;But above-mentioned two
Plant design and be most common design, there is sample and eye is closely sealed tight, be pasted not strongly solid shortcoming.
The content of the invention
It is an object of the invention to provide it is a kind of transparent, ventilative, waterproof, not good with tissue adhesion, pliability, with good
Biocompatibility, and preparation process is simple, cost of manufacture it is relatively low suitable for general anesthesia operation patient or depth coma patient, energy
Prevention, the hydrogel eye protection sticking dressing of the generation of control exposure keratitises.
The invention discloses it is a kind of transparent, ventilative, waterproof, not good with tissue adhesion, pliability, with good biofacies
Capacitive energy, it is adaptable to general anesthesia operation patient or depth coma patient, can prevent, control the water-setting of the generation of exposure keratitises
Glue eye protection sticking dressing and preparation method thereof.Hydrogel eye protection sticking dressing, successively by adhesion layer, enhancement layer, gel layer and sealing coat
Four layers of composition, enhancement layer are glasses frame-type, and adhesion layer and sealing coat overall dimensions are more than gel layer and enhancement layer, the shape of adhesion layer
Shape exceeds gel layer, is partially coated with viscose glue beyond the adhesion layer of gel layer, more meets human engineering through particular design, edge
Principle.
Gel layer main component be water miscible high molecular polymer, with pseudoplastic functional polymer, wetting agent and
Water, Jing series of process by its it is molten be integrated, solution pour into a mould in a mold, after solidification Jing irradiation sterilizations obtain.Properties of product are examined
Survey, moistening effect experimental test result shows that the present invention has good biocompatibility, make without sensitization, non-stimulated, nontoxic pair
With, and with good moisture retention, be retentive of moisture more than 90% at least 8 hours.
The invention provides a kind of hydrogel eye protection sticking dressing, includes gel layer, its main component is water miscible height
Molecularly Imprinted Polymer, with pseudoplastic functional polymer, wetting agent and water.
Specifically, the gel layer of above-mentioned hydrogel eye protection sticking dressing is made up of following component by mass percentage:Water
Soluble macromolecular polymer 2%-15%, pseudoplastic behavior high molecular polymer 0.1%-5%, wetting agent 0.1%-10%, remaining is
Water, each component sum are 100%, the wherein preferred 2%-4% of pseudoplastic behavior high molecular polymer.
Above-mentioned high molecular weight water soluble polymer can be one or more in the high molecular polymer of natural and synthesis, or
For a combination of both.
Above-mentioned water-soluble high molecular polymer can be Chitosan-phospholipid complex, alginic acid and its derivant and transparent
The combination of one or more in matter acid and its derivant etc.;Chitosan derivatives may be selected from hydroxypropyl chitosan, carboxymethyl shell
Polysaccharide and succinyl-chitosan etc.;Alginic acid derivative may be selected from sodium alginate, alginic acid magnesium, calcium alginate and potassium alginate
Deng;Derivatives of hyaluronic acids may be selected from hyaluronic acid, hyaluronate sodium, calcium hyauronate and Curiosin etc..
Water-soluble high molecular polymer has unique biocompatibility and biological activity, can be used as hydrogel eye protection
The effective ingredient of sticking dressing.When radiation method prepares medical aquogel eye protection sticking dressing, add a certain proportion of water-soluble height
Molecularly Imprinted Polymer, can improve the biocompatibility of hydrogel:Meanwhile, water-soluble natural high molecular polymer is under actinism
Can be filled in gel network space after degraded, play a part of to improve gel strength.
The high molecular weight water soluble polymer of above-mentioned synthesis can be polyurethane, polyacrylamide, polyvinyl alcohol, polyvinyl pyrrole
The combination of one or more in alkanone, polyethylene glycol oxide and sodium polyacrylate, wherein more preferably high molecular polymer is poly-
Vinyl alcohol and polyvinylpyrrolidone.
The high molecular weight water soluble polymer of synthesis is because of its good biocompatibility, mechanical performance and safety, and extensive
It is applied in medical industry.The hydrogel being such as produced from it having extensively in terms of ophthalmology, wound dressing and artificial joint
Using, with unique strong adherence, pliability, flatness, oil resistivity, solvent resistance, protecting colloid, wearability and
It is specially treated that there is resistance to water.
Above-mentioned can be the one kind in agar powder, agarose, gelatin and carrageenan etc. with pseudoplastic high molecular polymer
Or several combinations.
Such polymer have dissolve in hot water in form solution, and after lowering the temperature, then form the property of false solid, to sample
Product play a part of pre- solid, are convenient for the operation of next step.
Above-mentioned wetting agent is the moisture that can effectively absorb the external world, and keeps the material of moisture, may be selected from polyalcohols moisturizing
One or more in agent, nature moisturizing factor, amino acidses wetting agent and macromolecule biochemistry class wetting agent, wherein more preferably
Wetting agent is nature moisturizing factor or macromolecule biochemistry class wetting agent;Polyalcohols wetting agent can be Propylene Glycol, glycerol, poly- second
Glycol, xylitol etc.;Nature moisturizing factor can be 2-pyrrolidone-5-carboxylic acid, pyrrolidone sodium carboxylate, sodium lactate, carbamide etc.;Amino
Acids wetting agent can be protide, such as:Vegetable protein, soybean protein, animal proteinum, hydrolyzed protein etc.;Macromolecule biochemistry class is protected
Humectant can be collagen protein, matter acid, hyaluronic acid, mucin and chondroitin sulfate etc., the wherein acid of preferably clear matter and collagen egg
In vain.
Above-mentioned water is purified water(Clean deionized water or distilled water).
It is a further object to provide a kind of method for preparing above-mentioned hydrogel eye protection sticking dressing, specifically may include
Following steps:
1)Gel layer each component is weighed by formula;
2)By high molecular weight water soluble polymer and have pseudoplastic high molecular polymer it is soluble in water, the water more than 90 DEG C
Backflow in bath forms homogeneous solution A, then wetting agent is dissolved in solution A, supplies ad pond om with water, is stirred into homogeneous molten
Liquid;
3)By step 2)In uniform solution carry out defoaming treatment, defoaming process keeping temperature is higher than 50 DEG C, maintains which equal
One solution state, pours into after froth breaking in shaping dies, is cooled into pseudoplastic behavior solid, and defoaming process keeping temperature is higher than 50 DEG C;
4)To step 3)In pseudoplastic behavior solid carry out cross-linking radiation and sterilizing at room temperature, form gel layer, irradiation side
Formula can be 60Co gamma-radiations or high-power electron beam ray, and exposure time is 10-40min, and irradiation dose is 10K-70K;
5)In order adhesion layer, enhancement layer, gel layer and sealing coat are combined, hydrogel eye protection sticking dressing is made.
In above-mentioned preparation method, the step 3)In defoaming treatment mode can be to stand froth breaking, ultrasonic froth breaking or true
Empty de-bubble.
In place of the positive progress of the present invention it is:
(1)The hydrogel eye protection sticking dressing is synchronously completed with sterilizing by radiation mode crosslinking, and preparation method is simple, significantly
Manufacturing cycle, and products pure are shortened, the gelatinous transparent degree height of gained, intensity are high.
(2)The present invention chooses agar powder, agarose, gelatin, carrageenan etc. with pseudoplastic high molecular polymer
One or more, make sample precuring at room temperature, form false gel, beneficial to the packaging before irradiation process and transport.
(3)Polyalcohols wetting agent, nature moisturizing factor, amino acidses wetting agent can be added in hydrogel in the present invention
Or one or more in macromolecule biochemistry class wetting agent, product water retention property can be strengthened.
(4)Adhesion layer is with the addition of above enhancement layer, the mechanical performance of gel film is not only strengthened, and is glued sample
That what is pasted is more firm, difficult for drop-off.
(5)The design of adhesion layer is more special, only the gluing at the non-woven fabrics not covered by gel layer 2, at the bridge of the nose and
Eye tail both sides are pasted, and only apply gel layer 2, both met the eye-care requirement of different position patients with general anesthesia, together at eyes and eyebrow
When the hair of de- patient will not be also glued when taking off, more conform to base of principle of human engineering.
In sum, hydrogel eye protection sticking dressing of the invention is substantially better than existing eye protection sticking dressing, with preferable
Performance of keeping humidity, action time, transparent, the ventilative, preparation method for extending product is simple, products pure, it is nontoxic, non-stimulated,
The advantages of good biocompatibility, and configuration design more conforms to base of principle of human engineering, suits large area to popularize and applies.
Description of the drawings
General structure schematic diagrams of the Fig. 1 for hydrogel eye protection sticking dressing;
Structural representations of the Fig. 2 for hydrogel eye protection sticking dressing enhancement layer;
Structural representations of the Fig. 3 for hydrogel eye protection sticking dressing gel layer;
Structural representations of the Fig. 4 for hydrogel eye protection sticking dressing adhesion layer;
In figure:1 sealing coat, 2 gel layers, 3 enhancement layers, 4 adhesion layers.
Specific embodiment
With reference to the accompanying drawings and examples the contour structures and preparation method of hydrogel eye protection sticking dressing are retouched in detail
State.
Hydrogel eye protection sticking dressing, from inside to outside successively by sealing coat 1, gel layer 2,4 four layers of group of enhancement layer 3 and adhesion layer
Into sealing coat 1 is the mould release membrance for scribbling silicone, and gel layer 2 is macromolecule hydrogel, and enhancement layer 3, adhesion layer 4 are Non-woven fabrics
Material.Gel layer 2 passes through mould and cross-linking radiation is fixed-type, and the nonwoven cloth material of adhesion layer 4 passes through itself adhesiveness
Combine closely with enhancement layer 3, the nonwoven cloth material of enhancement layer 3 is tight with gel layer 2 by hydrogel cross-linking radiation fixation procedure
Sealing coat 1 is covered with reference to, adhesion layer 4 and 2 top of gel layer.1 size of sealing coat is more than adhesion layer 4, sealing coat 1 and adhesion layer 4
Overall dimensions are more than gel layer 2 and enhancement layer 3,2 periphery sizableness of enhancement layer 3 and gel layer, the only left and right two ends of enhancement layer 3 compared with
Gel layer 2 is slightly longer.Enhancement layer 3 is glasses frame-type, and 4 edge of adhesion layer exceeds gel layer 2, adhesion in left and right, lower section and surface
4 shape of layer through particular design, only beyond gluing at the non-woven fabrics of gel layer 2, at the bridge of the nose and eye tail both sides are pasted, eyes
With at eyebrow only apply gel layer 2, both met the eye-care requirement of different position patients with general anesthesia, while will not also glue when taking off de-
The hair of patient, more conforms to base of principle of human engineering.
Mould release membrance 1 is torn from gel layer 2 during use by hydrogel eye protection sticking dressing, will be solidifying using the viscosity of gel layer
Glue-line is attached to eye, presses lightly on, and makes gel layer combine closely with eye part skin, and is fixed in eye using adhesion layer 4,
Required with the eye-care for meeting different position patients with general anesthesia.
Embodiment is implemented under premised on technical solution of the present invention, gives detailed embodiment and specific
Operating process, embodiment will be helpful to understand the present invention, but protection scope of the present invention is not limited to following embodiments.
In following embodiments, method therefor is conventional method if no special instructions.
Embodiment 1-10, prepare hydrogel eye protection sticking dressing
The gel layer formula of embodiment of the present invention 1-10 hydrogel eye protection sticking dressing and comparative example is as shown in table 1-2
The gel layer formula of 1 embodiment 1-5 hydrogel eye protection sticking dressing of table and comparative example 1
(The grams of each component in per 1000g hydrogels)
The gel layer formula of 2 embodiment 6-10 hydrogel eye protection sticking dressing of table and comparative example 2
(The grams of each component in per 1000g hydrogels)
Test one, particular product performance parameters detection
The performance parameter of the hydrogel eye protection sticking dressing of embodiment 1-10 preparation is detected, the product of embodiment 1-10
Meet claimed below:
1st, outward appearance:For colourless or show slightly milky clear gel.
2nd, water content:The sample of Example 1-10, according to《Pharmacopoeia of People's Republic of China》(Version two in 2010)It is attached
Recording VIII L " dry weightless mensuration " is carried out.The sample moisture content of embodiment 1-10 is all higher than 80%.
3rd, product itself bacteria-measuring:Method is carried out by GB/T14233.2-2005 pertinent regulations.Measurement result shows to produce
Product itself are aseptic.
4th, Eye irritation is determined:Eye paste is extracted in 0.1g/ml ratios, extraction medium is respectively normal saline and cotton
Seed is oily, and extraction temperature is(37±1)DEG C, extraction time is(72±2)H, takes lixiviating solution according to advising by GB/T16886.10-2005
Fixed method is carried out, should be without Eye irritation.Measurement result shows product without Eye irritation.
5th, sensitization of skin reaction assay:The closed sensitization test (STT) method specified by GB/T16886.10-2005 is carried out,
React without sensitization of skin.Measurement result shows that product does not cause sensitization of skin to react.
Test two, moistening effect test
In order to verify the moistening effect of subject hydrogel eye protection sticking dressing, choosing embodiment carries out moisturizing effect with comparative example
Fruit controlled trial.Concrete test method is as follows:
In temperature(25±1)DEG C, relative humidity(50±5)%(Sham operated room temperature humidity condition)Constant temperature culture test
In case, embodiment is measured with electronics moisture probe and changed with the humidity in the relative confined space under comparative sample, test week
Phase is 8 hours.
As shown in table 3, from following table, the result of humidity draws result of the test:Under prescribed test conditions, in 5 minutes,
In embodiment, sample can make the humidity in local environment up to more than 80%, and in 15 minutes, sample can make wet in local environment
Degree is up to more than 90%, and is retentive of moisture at least 8 hours time more than 90%.By embodiment and comparative example 1, comparative example 2
Comparison of test results analysis, it is known that:The addition of pseudoplastic high molecular polymer, can not only play the work of cold curing
With, also extend moistening effect effect;The addition of wetting agent can then be remarkably reinforced the water retention property of product, make product moisturizing
It is better.
3 moistening effect result of the test of table
Humidity |
5min |
15min |
30min |
2h |
4h |
8h |
Embodiment 1 |
85.3% |
90.6% |
91.0% |
91.1% |
91.5% |
91.4% |
Embodiment 2 |
86.2% |
93.2% |
93.4% |
93.8% |
94.0% |
94.1% |
Embodiment 3 |
85.5% |
90.5% |
90.8% |
91.0% |
91.2% |
91.2% |
Embodiment 4 |
83.4% |
89.7% |
90.0% |
90.1% |
90.5% |
90.6% |
Embodiment 5 |
92.6% |
94.0% |
94.5% |
94.8% |
95.2% |
95.1% |
Embodiment 6 |
91.7% |
93.5% |
94.1% |
94.2% |
94.9% |
95.0% |
Embodiment 7 |
95.0% |
95.1% |
95.3% |
95.2% |
95.4% |
95.5% |
Embodiment 8 |
92.0% |
94.2% |
94.6% |
94.7% |
94.8% |
94.7% |
Embodiment 9 |
87.5% |
90.1% |
90.4% |
90.9% |
91.0% |
91.2% |
Embodiment 10 |
86.8% |
93.4% |
93.5% |
93.9% |
94.3% |
94.5% |
Comparative example 1 |
85.2% |
86.8% |
87.1% |
87.5% |
88.0% |
88.2% |
Comparative example 2 |
64.3% |
65.7% |
66.3% |
67.4% |
68.3% |
70.5% |
In addition, it should be noted that embodiment listed above and comparative example are only the parts of the present invention, but the present invention
It is not limited thereto, more can also be deformed.Therefore, one of ordinary skill in the art can disclose part from the present invention
Other the available deformations directly derived or associate, are accordingly to be regarded as the protection content of the present invention.