CN111346074A - Novel medical hydrogel eye-protecting patch and preparation method thereof - Google Patents
Novel medical hydrogel eye-protecting patch and preparation method thereof Download PDFInfo
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- CN111346074A CN111346074A CN201811575882.9A CN201811575882A CN111346074A CN 111346074 A CN111346074 A CN 111346074A CN 201811575882 A CN201811575882 A CN 201811575882A CN 111346074 A CN111346074 A CN 111346074A
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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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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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
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Abstract
The invention relates to a novel medical hydrogel eye-protecting patch and a preparation method thereof, wherein the novel medical hydrogel eye-protecting patch comprises a dressing body and a plastic uptake tray; the dressing body comprises an upper release film protective layer, an adhesive layer, a lower release paper layer (outer ring), a non-woven fabric layer (inner ring) and a hydrogel layer from top to bottom; the hydrogel layer is transparent hydrogel with a flat upper surface and a concave lower surface and is in a flat concave structure; the non-woven fabric layer is a middle bridging layer of the flat surface of the hydrogel layer and the sticking layer; covering release paper on the outer ring of the adhesive surface of the adhesive layer along the non-woven edge cloth; the plastic suction tray is attached to the hydrogel, so that the shape of the whole product is supported; wherein the hydrogel layer is composed of hydrophilic high molecular polymer skeleton material, and optionally functional high molecular material, humectant and therapeutic agent are added; the gel is prepared by sol, filling, repeated freeze thawing and irradiation crosslinking; the invention provides a novel medical hydrogel eye protection patch, which can provide a closed moisturizing environment for the eyes of a patient in operation and observe the damage condition of the eyes at any time so as to take treatment measures in time; the flat concave structure does not press the eyeball.
Description
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to a novel medical hydrogel eye-protecting patch.
Background
Under the action of the general anesthesia operation sleepy anesthetic drug muscle relaxant, eyelids are loosened, eyelids can not be normally closed, and cornea is exposed, so that the exposed keratitis is a common complication in the general anesthesia operation period, symptoms such as foreign body sensation, photophobia, ache, lacrimation and the like are common in eyes after the operation, keratitis and even corneal ulcer can be caused in severe cases, delayed recovery and extra pain are caused, the eyes are protected in the operation process, and the eye complication can be effectively prevented.
The hydrogel is formed by physically crosslinking medical high polymer materials and has water retention; the eye patch covers the outside of the eye, plays a role in physically isolating and covering the eye in the whole operation process, and can enable the eye to be in a relatively closed and moist environment; has effects in moistening cornea and preventing exposed keratitis.
Hydrogel eye patches are developed by a plurality of research institutions at present and used for protecting eyes, and the products relieve the phenomenon of exposed eye injury in clinic, but have poor application practicability in clinic and have the following problems:
the poor adhesion and the poor tightness cause that the disinfectant enters eyes through the gap between the eye patch and the skin to stimulate the eyes;
the transparency is poor, doctors cannot judge the bleeding condition of the eyes in time through observation, and measures cannot be taken pertinently, so that the injury is aggravated.
Disclosure of Invention
The purpose of the invention is as follows: in order to overcome the defects of the prior art, the invention provides a novel medical hydrogel eye protection patch which can provide a closed moisturizing environment for the eyes of a patient in operation and observe the damage condition of the eyes at any time so as to take treatment measures in time; the flat concave structure does not press the eyeball.
The technical scheme is as follows: in order to realize the technical purpose, the invention provides a novel medical hydrogel eye-protecting plaster, which comprises a dressing body and a plastic uptake tray; the dressing body comprises an upper release film protective layer, an adhesive layer, a lower release paper layer (outer ring), a non-woven fabric layer (inner ring) and a hydrogel layer from top to bottom; the hydrogel layer is transparent hydrogel with a flat upper surface and a concave lower surface and is in a flat concave structure; the non-woven fabric layer is a middle bridging layer of the flat surface of the hydrogel layer and the sticking layer; covering release paper on the outer ring of the adhesive surface of the adhesive layer along the non-woven edge cloth; the plastic uptake tray is attached to the hydrogel, and the shape of the whole product is supported.
Specifically, the hydrogel layer is pasted on the non-woven fabric layer, then the non-woven fabric layer is compounded with the pasting layer, the non-woven fabric layer and the pasting layer are hollowed at positions corresponding to pupils of two eyes, the two hollowed-out edges are aligned, the hollowed-out area is enough to enable the two eyes to be exposed, and the hollowed-out area is not larger than the surface area of the hydrogel layer. And a visual window is formed by utilizing the characteristic that the hydrogel layer is highly transparent.
The invention has the beneficial effects that: through the visual window, doctors can observe the change condition of the eyes of patients at any time conveniently in the operation, and a good totally-enclosed micro-wet environment can be provided for the eyes.
On the basis of the technical scheme, the invention can be further improved as follows.
Further, the hydrogel layer is made of 5-25% by mass of a hydrophilic high polymer framework material, and 0.01-10% by mass of a functional high polymer material can be optionally added.
The hydrophilic high molecular polymer skeleton material comprises polyvinyl alcohol, polyacrylic acid, polyacrylate or a mixture of polyvinyl alcohol and polyvinylpyrrolidone.
The functional polymer material comprises one or more of chitin and derivatives thereof, gelatin, starch, alginate, cellulose and derivatives thereof, hyaluronic acid and derivatives thereof, and the like.
The hydrogel component material can be optionally added with a humectant which is 0.1-10% by mass, wherein the humectant comprises but is not limited to one or a mixture of more than two of propylene glycol, glycerol or sorbitol.
The hydrogel component material can be optionally added with 0.001% -2% of therapeutic agents in percentage by mass, wherein the therapeutic agents include but are not limited to one or more of analgesic drugs, hormone drugs, anti-allergy drugs, antibiotics, antiviral drugs, growth factors and inorganic salts.
The invention has the beneficial effects that:
⑴ good biocompatibility, no sensitization, no irritation, and no cytotoxicity;
⑵ has long moisture retention time, and can retain moisture for more than 20 hours;
⑶ has good adhesion, and can be adhered to eye with high adhesion;
⑷ can protect eyes and simultaneously play a corresponding role in treatment or maintenance;
a method for preparing the novel medical hydrogel eye-protecting patch comprises the following steps:
⑴, pouring 5-25% of hydrophilic high molecular polymer and 0.1-10% of humectant into a vacuum reaction kettle, fully dissolving to form a solution, and stirring at 70 ℃ under the vacuum condition until the solution is viscous;
⑵, fully dissolving 0.01-10 wt% of functional polymer material and 0.001-2 wt% of therapeutic agent at normal temperature to form a solution;
⑶ cooling the viscous solution prepared in step ⑴ to below 60 deg.C, adding the solution prepared in step ⑵, and stirring to mix completely;
⑷ injecting the mixed solution prepared in step ⑶ into a plastic tray, and cooling to semi-gel state;
⑸ coating the cut nonwoven fabric on the semi-gel hydrogel viscous solution prepared in step ⑶;
⑹ repeatedly freezing and thawing the non-woven fabric-coated hydrogel-state viscous solution prepared in step ⑸ for 1-3 times to form a hydrogel semi-finished product;
⑺ coating the semi-finished product of hydrogel prepared in step ⑹ with the cut adhesive layer with release paper on the outer ring of the adhesive surface, and bonding with non-woven fabric to obtain semi-finished product of eye protecting patch;
⑻, irradiating the hydrogel eye protection paste prepared in the step ⑺ under electron beams with the dosage of 25-35 kGy, and thus obtaining the novel hydrogel eye protection paste.
The invention has the beneficial effects that:
1. the hydrogel subjected to freeze thawing and irradiation crosslinking has high transparency, and the change of eyes can be directly observed through the hydrogel;
2. the irradiation crosslinking and the irradiation sterilization are combined into a whole, so that the hydrogel can be crosslinked to form a three-dimensional network structure, the water locking capacity is improved, the sterilization effect is achieved while the crosslinking is carried out, the energy is saved, and the production efficiency is improved.
Drawings
Fig. 1 is a schematic view of the overall structure of the medical hydrogel eye-protecting patch with partially visible part;
the list of components represented by the various reference numbers in the figures is as follows: 1. The plastic-absorbing plastic tray comprises a release film layer, 2 a sticking layer, 2-1 a sticking layer hollow 3, a non-woven fabric layer, 3-1 a lower isolation paper layer, 3-2 a non-woven fabric hollow 4, a hydrogel layer, 5 and a plastic-absorbing tray.
Detailed Description
The present invention will be further described with reference to the following embodiments. Example 1
⑴ pouring 10 wt% polyvinyl alcohol, 5 wt% polyvinylpyrrolidone, 1.5 wt% glycerol, and 1 wt% sorbitol into a vacuum reaction kettle, dissolving to obtain a solution, and stirring at 70 deg.C under vacuum condition until the solution is viscous;
⑵ dissolving 0.05 wt% hyaluronic acid and 0.01 wt% growth factor in purified water at room temperature to obtain solution;
⑶ cooling the viscous solution prepared in step ⑴ to below 60 deg.C, adding the solution prepared in step ⑵, and stirring to mix completely;
⑷ injecting the mixed solution prepared in step ⑶ into a plastic tray, and cooling to semi-gel state;
⑸ coating the cut nonwoven fabric on the semi-gel hydrogel viscous solution prepared in step ⑶;
⑹ repeatedly freezing and thawing the viscous solution coated with the non-woven fabric hydrogel state obtained in step ⑸ for 3 times to form a hydrogel semi-finished product;
⑺ coating the semi-finished product of hydrogel prepared in step ⑹ with the cut adhesive layer with release paper on the outer ring of the adhesive surface, and bonding with non-woven fabric to obtain semi-finished product of eye protecting patch;
⑻, irradiating the hydrogel eye protection paste prepared in the step ⑺ under electron beams with the dosage of 25-35 kGy, and thus obtaining the novel hydrogel eye protection paste.
Example 2
⑴ pouring 15 wt% sodium polyacrylate and 2.5 wt% glycerol into a vacuum reaction kettle, dissolving in purified water to form a solution, and stirring at 70 deg.C under vacuum condition until the solution is viscous;
⑵ dissolving 5 wt% of gelatin and 0.005 wt% of anti-allergy medicine in purified water at room temperature to obtain solution;
⑶ cooling the viscous solution prepared in step ⑴ to below 60 deg.C, adding the solution prepared in step ⑵, and stirring to mix completely;
⑷ injecting the mixed solution prepared in step ⑶ into a plastic tray, and cooling to semi-gel state;
⑸ coating the cut nonwoven fabric on the semi-gel hydrogel viscous solution prepared in step ⑶;
⑹ repeatedly freezing and thawing the viscous solution coated with the non-woven fabric hydrogel state obtained in step ⑸ for 3 times to form a hydrogel semi-finished product;
⑺ coating the semi-finished product of hydrogel prepared in step ⑹ with the cut adhesive layer with release paper on the outer ring of the adhesive surface, and bonding with non-woven fabric to obtain semi-finished product of eye protecting patch;
⑻, irradiating the hydrogel eye protection paste prepared in the step ⑺ under electron beams with the dosage of 25-35 kGy, and thus obtaining the novel hydrogel eye protection paste.
Example 3
⑴ pouring 15% polyvinyl alcohol and 2% glycerol into a vacuum reaction kettle, dissolving to form a solution, and stirring at 70 deg.C under vacuum condition until the solution is viscous;
⑵ dissolving 0.05 wt% hyaluronic acid and 0.005 wt% analgesic in purified water at room temperature to obtain solution;
⑶ cooling the viscous solution prepared in step ⑴ to below 60 deg.C, adding the solution prepared in step ⑵, and stirring to mix completely;
⑷ injecting the mixed solution prepared in step ⑶ into a plastic tray, and cooling to semi-gel state;
⑸ coating the cut nonwoven fabric on the semi-gel hydrogel viscous solution prepared in step ⑶;
⑹ repeatedly freezing and thawing the viscous solution coated with the non-woven fabric hydrogel state obtained in step ⑸ for 3 times to form a hydrogel semi-finished product;
⑺ coating the semi-finished product of hydrogel prepared in step ⑹ with the cut adhesive layer with release paper on the outer ring of the adhesive surface, and bonding with non-woven fabric to obtain semi-finished product of eye protecting patch;
⑻, irradiating the hydrogel eye protection paste prepared in the step ⑺ under electron beams with the dosage of 25-35 kGy, and thus obtaining the novel hydrogel eye protection paste.
Example 4
⑴ pouring 10 wt% polyvinyl alcohol, 1.5 wt% glycerol, and 1 wt% propylene glycol into a vacuum reaction kettle, dissolving to obtain a solution, and stirring at 70 deg.C under vacuum condition until the solution is viscous;
⑵ dissolving sodium alginate 5 wt% and growth factor 0.005 wt% in purified water at room temperature to form solution;
⑶ cooling the viscous solution prepared in step ⑴ to below 60 deg.C, adding the solution prepared in step ⑵, and stirring to mix completely;
⑷ injecting the mixed solution prepared in step ⑶ into a plastic tray, and cooling to semi-gel state;
⑸ coating the cut nonwoven fabric on the semi-gel hydrogel viscous solution prepared in step ⑶;
⑹ repeatedly freezing and thawing the viscous solution coated with the non-woven fabric hydrogel state obtained in step ⑸ for 3 times to form a hydrogel semi-finished product;
⑺ coating the semi-finished product of hydrogel prepared in step ⑹ with the cut adhesive layer with release paper on the outer ring of the adhesive surface, and bonding with non-woven fabric to obtain semi-finished product of eye protecting patch;
⑻, irradiating the hydrogel eye protection paste prepared in the step ⑺ under electron beams with the dosage of 25-35 kGy, and thus obtaining the novel hydrogel eye protection paste.
Example 5
⑴ pouring 5 wt% polyvinyl pyrrolidone 2.5 wt% glycerol into vacuum reaction kettle, dissolving to obtain solution, and stirring at 70 deg.C under vacuum condition until the solution is viscous;
⑵ dissolving sodium alginate 20 wt% and hormone medicine 0.002 wt% in purified water at room temperature to form solution;
⑶ cooling the viscous solution prepared in step ⑴ to below 60 deg.C, adding the solution prepared in step ⑵, and stirring to mix completely;
⑷ injecting the mixed solution prepared in step ⑶ into a plastic tray, and cooling to semi-gel state;
⑸ coating the cut nonwoven fabric on the semi-gel hydrogel viscous solution prepared in step ⑶;
⑹ repeatedly freezing and thawing the viscous solution coated with the non-woven fabric hydrogel state obtained in step ⑸ for 3 times to form a hydrogel semi-finished product;
⑺ coating the semi-finished product of hydrogel prepared in step ⑹ with the cut adhesive layer with release paper on the outer ring of the adhesive surface, and bonding with non-woven fabric to obtain semi-finished product of eye protecting patch;
⑻, irradiating the hydrogel eye protection paste prepared in the step ⑺ under electron beams with the dosage of 25-35 kGy, and thus obtaining the novel hydrogel eye protection paste.
And (3) performance testing:
the physical properties of the novel hydrogel eye-protection patches prepared in examples 1 to 5 of the present invention, including biocompatibility test, moisture-retaining effect measurement and light transmittance measurement, were measured, respectively, and the results are shown in table 1.
And (3) biocompatibility test:
according to GB/T16886.5-2003 part 5 of medical device biology evaluation: in vitro cytotoxicity test, cytotoxicity test was performed;
according to GB/T16886.10-2005 Bioevaluation of medical devices-part 10: stimulation and delayed hypersensitivity tests, intradermal stimulation tests;
according to GB/T16886.10-2005 Bioevaluation of medical devices-part 10: irritation and delayed hypersensitivity test the skin sensitization test was performed.
And (3) testing the moisturizing effect:
the eye patch is pasted on a steel plate, the steel plate is placed in a constant temperature and humidity test box with the temperature of 25 +/-1 ℃ and the relative humidity of 50 +/-5 percent (simulating the temperature and humidity condition of an operating room), and the electronic humidity probe is used for measuring the relative closed humidity covered by the eye patch after 20 hours.
TABLE 1 Performance test
As can be seen from the table above, the novel hydrogel eye-protecting patch prepared by the invention has good biocompatibility, good moisturizing performance and lasting moisturizing effect.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (8)
1. A novel medical hydrogel eye-protecting patch is characterized by comprising a dressing body and a plastic uptake tray; the dressing body comprises an upper release film protective layer, an adhesive layer, a lower release paper layer (outer ring), a non-woven fabric layer (inner ring) and a hydrogel layer from top to bottom; the hydrogel layer is transparent hydrogel with a flat upper surface and a concave lower surface and is in a flat concave structure; the non-woven fabric layer is a middle bridging layer of the flat surface of the hydrogel layer and the sticking layer; covering release paper on the outer ring of the adhesive surface of the adhesive layer along the non-woven edge cloth; the plastic uptake tray is attached to the hydrogel, and the shape of the whole product is supported.
2. The hydrogel layer of claim 1 is adhered to the non-woven fabric layer and then combined with the adhesive layer through the non-woven fabric layer, wherein the non-woven fabric layer and the adhesive layer are hollowed at positions corresponding to pupils of two eyes, and the hollowed edges of the two layers are aligned, and the hollowed area is enough to expose the two eyes and is not larger than the surface area of the hydrogel layer; forming a visual window by utilizing the characteristic that the hydrogel layer is highly transparent; the hydrogel layer is adhered to the non-woven fabric layer and then is compounded with the adhering layer through the non-woven fabric layer, the non-woven fabric layer and the adhering layer are hollowed at positions corresponding to pupils of two eyes, the hollowed edges of the two layers are aligned, and the hollowed area is enough to enable the two eyes to be exposed and is not larger than the surface area of the hydrogel layer; and a visual window is formed by utilizing the characteristic that the hydrogel layer is highly transparent.
3. The preparation method of the novel medical hydrogel eye patch as claimed in claim 1, wherein the hydrogel layer is made of 5-25% by mass of hydrophilic polymer skeleton material, and 0.01-10% by mass of functional polymer material is optionally added.
4. The method for preparing a novel medical hydrogel eye patch according to claim 3, wherein the hydrophilic high molecular polymer skeleton material comprises polyvinyl alcohol, polyacrylic acid, polyacrylate or a mixture of polyvinyl alcohol and polyvinylpyrrolidone.
5. The novel medical hydrogel eye patch according to claim 3, wherein the functional polymer material comprises chitin and its derivatives, gelatin, starch, alginate, cellulose and its derivatives, hyaluronic acid and its derivatives, etc.
6. The novel medical hydrogel eye patch as claimed in claim 3, wherein a humectant is optionally added to the hydrogel component material in an amount of 0.1% to 10% by mass, wherein the humectant includes but is not limited to one or a mixture of two or more of propylene glycol, glycerol, and sorbitol.
7. The preparation method of the novel medical hydrogel eye patch as claimed in claim 3, wherein 0.001% -2% by mass of a therapeutic agent is optionally added to the hydrogel component materials, and the therapeutic agent includes but is not limited to one or more of analgesic drugs, hormone drugs, anti-allergy drugs, antibiotics, antiviral drugs, growth factors, and inorganic salts.
8. The preparation method of the novel medical hydrogel eye patch according to claim 1, which is characterized by comprising the following steps:
⑴, pouring 5-25% of hydrophilic high molecular polymer and 0.1-10% of humectant into a vacuum reaction kettle, fully dissolving to form a solution, and stirring at 70 ℃ under the vacuum condition until the solution is viscous;
⑵, fully dissolving 0.01-10 wt% of functional polymer material and 0.001-2 wt% of therapeutic agent at normal temperature to form a solution;
⑶ cooling the viscous solution prepared in step ⑴ to below 60 deg.C, adding the solution prepared in step ⑵, and stirring to mix completely;
⑷ injecting the mixed solution prepared in step ⑶ into a plastic tray, and cooling to semi-gel state;
⑸ coating the cut nonwoven fabric on the semi-gel hydrogel viscous solution prepared in step ⑶;
⑹ repeatedly freezing and thawing the non-woven fabric-coated hydrogel-state viscous solution prepared in step ⑸ for 1-3 times to form a hydrogel semi-finished product;
⑺ coating the semi-finished product of hydrogel prepared in step ⑹ with the cut adhesive layer with release paper on the outer ring of the adhesive surface, and bonding with non-woven fabric to obtain semi-finished product of eye protecting patch;
⑻, irradiating the hydrogel eye protection paste prepared in the step ⑺ under electron beams with the dosage of 25-35 kGy, and thus obtaining the novel hydrogel eye protection paste.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103494668A (en) * | 2013-09-30 | 2014-01-08 | 长沙海润生物技术有限公司 | Medical hydrogel moisturizing eye care mask and preparation method thereof |
| CN103893157A (en) * | 2014-04-09 | 2014-07-02 | 山东赛克赛斯药业科技有限公司 | Hydrogel eye protective pad dressing and preparation method thereof |
| CN205108056U (en) * | 2015-11-18 | 2016-03-30 | 长春吉原生物科技有限公司 | Moist eye of aquogel pastes |
| CN206334009U (en) * | 2016-06-28 | 2017-07-18 | 邯郸沃伦多科技开发有限公司 | One kind extension medical eye paste of moisturizing |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103494668A (en) * | 2013-09-30 | 2014-01-08 | 长沙海润生物技术有限公司 | Medical hydrogel moisturizing eye care mask and preparation method thereof |
| CN103893157A (en) * | 2014-04-09 | 2014-07-02 | 山东赛克赛斯药业科技有限公司 | Hydrogel eye protective pad dressing and preparation method thereof |
| CN205108056U (en) * | 2015-11-18 | 2016-03-30 | 长春吉原生物科技有限公司 | Moist eye of aquogel pastes |
| CN206334009U (en) * | 2016-06-28 | 2017-07-18 | 邯郸沃伦多科技开发有限公司 | One kind extension medical eye paste of moisturizing |
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