The utility model content
The purpose of this utility model is the deficiency that exists at the above table dressing, provides a kind of and has the curved surface that adapts with eyeball and form close eye-surface biological film with people's cornea, conjunctiva.
The technical solution of the utility model is: a kind of eye-surface biological film, and for having the animal membrane to the similar curved surface of eyeball.
Be provided with the medicament slow release layer in the described biomembrane curved surface.
Have in the described biomembrane curved surface by the ventilative micropore of biomembrane natural micropore through suitably enlarging.
In the described biomembrane curved surface lubricating layer is set.
This utility model is achieved in that a kind of eye-surface biological film, is made into by following steps:
(1) the animal membrane material is got in selection;
(2) pretreatment: prune and remove excess tissue, fiber or fine hair etc.;
(3) ungrease treatment: with organic solvent extraction fatty impurity wherein;
(4) take off cell: under the protectant effect of collagen, decompose cell with surfactant or protease;
(5) the multi-faceted antigen that removes is handled: combine with being in active group certain special position, that cause immune rejection in some active nucleopilic reagents and the collagen protein, with its sealing, and use strong hydrogen bonding and form agent destruction and cause antigenic special conformation;
(6) fixing: as with epoxide the collagen in the film material to be carried out crosslinked fixing, to improve its stability;
(7) curved surface forming: making film material forming with the sphere mould is corresponding curved surface with eyeball;
(8) finishing;
(9) packing;
(10) virus of going out: gamma-radiation irradiation sterilization;
(11) finished product.
The animal membrane material of being got comprises pericardium, goldbeater's skin, fat nethike embrane, the placenta amnion of animals such as pig, cattle, sheep;
Described pretreatment is to prune to remove excess tissue, fiber or fine hair etc.;
Described ungrease treatment is that organic solvent can be acetate esters, chloroform, carbon tetrachloride, ether, acetone, dehydrated alcohol with organic solvent extraction fatty impurity wherein;
Described take off cell be with the surfactant elution method and in the presence of collagen is protectant enzymatic isolation method, both use separately or both should be used for realizing simultaneously; Surfactant is ethylenediaminetetraacetic acid, benzyl fluosulfonic acid, Triton X-100 (Tritonx100), Tris (Tris), and the used enzyme of enzymatic isolation method is a protease, can be trypsin and pepsin etc.
The described multi-faceted antigen that removes is handled, be in certain special position with in some active nucleopilic reagents and the collagen protein, cause that the active group of immune rejection combines, with its sealing, and application strong hydrogen bonding formation agent destruction causes antigenic special conformation; Active group described here mainly is-OH
*,-NH
2 *,-SH
*Deng; Applicable active nucleopilic reagent has anhydride, amide, epoxide etc.; Applicable strong hydrogen bonding forms agent guanidine compound.
The fixing processing of described epoxy is meant with epoxide carries out crosslinked fixing to the collagen protein in the film material, to improve its stability.Used epoxide can be the carbochain epoxide
R=C wherein
nH
2n+1-,
N=0,1~10, also can be carbon oxygen chain epoxide
R=C wherein
nH
2n+1-,
R '=H, CH
3-(C
2H
5)
n-, n=0,1,2 ... n, x=0,1,2 ... x.Compare with traditional glutaraldehyde fixation, the fixed cross-bond of epoxy is stable, can not discharge deleterious aldehydes, non-residual toxicity during degraded.
Described molding is that to make film material forming with the sphere mould be corresponding curved surface with eyeball.
In addition, this product also can increase the finishing of slow release treatment medicine according to the treatment needs after molding, and method is with the slow release lapping medicine to be wrapping on the product; Or the modification of increase lubricity, method is that hyaluronic acid is introduced this biomembrane; Maybe can increase the finishing of breathability, method is to make with the multi tension typing method that micropore suitably enlarges in the film.
At last product is packed with the double-layer plastic bag, the reuse sufficient dosage (as>30KGy) gamma-radiation irradiation sterilization, to kill the exogenous or animal derived virus and the pathogenic bacteria that may exist.
It is raw material with the animal membrane material that this utility model provides a kind of, replace glutaraldehyde to fix with epoxide, use the multi-faceted antigen technology of removing and remove antigen, carry out effective deactivation with the radiating classical sterilization of 25KGy gamma-radiation to the potential virus of possibility, again the sphere biomembrane that makes through molding with certain curvature radius.The utlity model has the curved surface similar, can be close to eyeball to eyeball; No antigen, histocompatibility is good, can participate in the agglutination of eye table wound, helps wound healing; Have air permeability and good and antibacterial filtering simultaneously, can play the good protection therapeutical effect the eye table; Have better intensity, can paste and can stitch, easy to use; Finishing by medicament slow release in addition, but also can be made into the therapeutic type eye-surface biological film of slow release anti-infectives.
The specific embodiment
Below in conjunction with the specific embodiment this utility model is described in detail.
A kind of eye-surface biological film as shown in Figure 1, is the animal membrane 1 that has to the similar curved surface of eyeball, can directly be affixed on ocular surface, is used for the treatment and the nursing of eye's cornea and conjunctival damage, inflammation, and the nursing after the corneal transplantation.According to the needs of treatment, be provided with the medicament slow release layer 2 of slow release treatment medicine in the animal membrane curved surface by finishing, as shown in Figure 2.Medicament slow release layer 2 is for to be wrapping to medicine on the animal membrane with the slow release lapping.In addition, animal membrane can be introduced lubricating layer, and to increase lubricity, lubricating layer can be a hyaluronic acid; Or the micropore of expansion is set by the multi tension typing method, to increase breathability.
It has the curved surface similar to eyeball a kind of eye-surface biological film of the present utility model, can be close to eyeball, its no antigen, and histocompatibility is good, can participate in the agglutination of eye table wound, helps wound healing; Have air permeability and good and antibacterial filtering, can play the good protection therapeutical effect the eye table; Have better intensity, can paste and can stitch, easy to use.Finishing by medicament slow release in addition, but also can be made into the therapeutic type eye-surface biological film of slow release anti-infectives.
A kind of eye-surface biological film of the present utility model is made into by following steps:
(1) get the animal membrane material: the animal membrane material that can choose comprises pericardium, goldbeater's skin, fat nethike embrane, placenta amnion of animals such as pig, cattle, sheep etc.;
(2) pretreatment: prune and remove impurity such as excess tissue, fiber or fine hair, with convenient follow-up processing;
(3) ungrease treatment: with organic solvent extraction fatty impurity wherein, the organic solvent that extracts fat can be dehydrated alcohol, ethyl acetate, acetone, chloroform etc.;
(4) take off cell: be with the surfactant elution method and in the presence of collagen is protectant enzymatic isolation method, both use separately or both should be used for realizing simultaneously; Surfactant is ethylenediaminetetraacetic acid, benzyl fluosulfonic acid, Triton X-100 (Tritonx100), Tris (Tris), and the used enzyme of enzymatic isolation method is a protease, can be trypsin and pepsin etc.
(5) the multi-faceted antigen that removes is handled: combine with being in active group certain special position, that cause immune rejection in some active nucleopilic reagents and the collagen protein, with its sealing, and use strong hydrogen bonding and form agent and destroy and cause antigenic special conformation, active group described here mainly is-OH
*,-NH
2 *,-SH
*Deng; Nucleopilic reagent can be anhydride, amide, epoxide etc.; It can be guanidine compound that strong hydrogen bonding forms agent.
(6) fixing: as with the carbochain epoxide collagen protein in the film material to be carried out crosslinked fixing, to improve its stability; Used epoxide can be the carbochain epoxide
R=C wherein
nH
2n+1-,
N=0,1~10, also can be carbon oxygen chain epoxide
R=C wherein
nH
2n+1-,
R '=H, CH
3-(C
2H
5)
n-, n=0,1,2 ... n, x=0,1,2 ... x.Compare with traditional glutaraldehyde fixation, the fixed cross-bond of epoxy is stable, can not discharge deleterious aldehydes, non-residual toxicity during degraded.
(7) curved surface forming: making film material forming with the sphere mould is corresponding curved surface with eyeball;
(8) finishing: can be according to the treatment needs, the animal membrane after molding increases the finishing of slow release treatment medicine, can be with the slow release lapping medicine to be wrapping on the animal membrane; Also can increase the modification of lubricity, as hyaluronic acid is introduced in the film body; Maybe can increase the finishing of breathability, make by the multi tension typing method that micropore suitably enlarges in the film.
(9) packing: product is packed with the double-layer plastic bag;
(10) virus of going out: with the gamma-radiation irradiation sterilization of sufficient dosage, to kill the exogenous or animal derived virus and the pathogenic bacteria that may exist, the dosage of used gamma-radiation is no less than 30KGy;
(11) finished product.
Embodiment 1
Get fresh pig pericardium or pig small intestine film, put into preservative specially and soak sterilization fresh, carefully remove the impurity on the striping, drain away the water, put into organic solvents such as dehydrated alcohol, ethyl acetate, acetone, chloroform, extracting is more than 6 hours, to remove fatty impurity wherein.Reuse protease hydrolyzed method removes wherein cell, and protease can be used trypsin, pepsin or both mixing.Hydrolysis temperature is 18-25 ℃, and enzymolysis time is more than 2 hours.Reuse is epoxy crosslinked fixing, and used epoxide is
Here R=C
nH
2n+1-or
N=0,1,2, n cleans, and drains, and reuse butyryl oxide. or butyl chloride seal active antigen group, and active here antigen group mainly is to contain-OH-NH
2, the specific activity group of-SH is to remove its antigenicity.Clean, the spherical film tool of reuse is pressed into curved surface and drawing and setting and forms as shown in Figure 1 the
animal membrane 1 to the similar curved surface of eyeball of having.Packing, the gamma-radiation radiation sterilization promptly gets product.