CN111821100A - Medical covering film, system containing same, use method and application of medical covering film - Google Patents
Medical covering film, system containing same, use method and application of medical covering film Download PDFInfo
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- CN111821100A CN111821100A CN201910300866.7A CN201910300866A CN111821100A CN 111821100 A CN111821100 A CN 111821100A CN 201910300866 A CN201910300866 A CN 201910300866A CN 111821100 A CN111821100 A CN 111821100A
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- 239000010410 layer Substances 0.000 claims abstract description 131
- 238000002360 preparation method Methods 0.000 claims abstract description 67
- 239000012790 adhesive layer Substances 0.000 claims abstract description 45
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 39
- 230000004888 barrier function Effects 0.000 claims abstract description 26
- 238000001179 sorption measurement Methods 0.000 claims abstract description 19
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- 239000010408 film Substances 0.000 claims description 75
- 239000000203 mixture Substances 0.000 claims description 74
- 238000009472 formulation Methods 0.000 claims description 71
- 239000003292 glue Substances 0.000 claims description 27
- 208000002193 Pain Diseases 0.000 claims description 21
- 230000036407 pain Effects 0.000 claims description 21
- 239000007787 solid Substances 0.000 claims description 21
- 239000013039 cover film Substances 0.000 claims description 19
- 239000000853 adhesive Substances 0.000 claims description 14
- 230000001070 adhesive effect Effects 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 9
- 239000006071 cream Substances 0.000 claims description 6
- 208000007514 Herpes zoster Diseases 0.000 claims description 4
- 230000003444 anaesthetic effect Effects 0.000 claims description 4
- 239000004745 nonwoven fabric Substances 0.000 claims description 4
- 230000002093 peripheral effect Effects 0.000 claims description 4
- 230000000699 topical effect Effects 0.000 claims description 4
- 230000002745 absorbent Effects 0.000 claims description 3
- 239000002250 absorbent Substances 0.000 claims description 3
- 239000005038 ethylene vinyl acetate Substances 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 201000008482 osteoarthritis Diseases 0.000 claims description 3
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 claims description 3
- 238000005507 spraying Methods 0.000 claims description 3
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- 201000005569 Gout Diseases 0.000 claims description 2
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- 208000005890 Neuroma Diseases 0.000 claims description 2
- 208000004983 Phantom Limb Diseases 0.000 claims description 2
- 206010056238 Phantom pain Diseases 0.000 claims description 2
- 239000004698 Polyethylene Substances 0.000 claims description 2
- 208000026137 Soft tissue injury Diseases 0.000 claims description 2
- 206010012601 diabetes mellitus Diseases 0.000 claims description 2
- 230000003100 immobilizing effect Effects 0.000 claims description 2
- 230000008764 nerve damage Effects 0.000 claims description 2
- 208000004296 neuralgia Diseases 0.000 claims description 2
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- 239000002362 mulch Substances 0.000 claims 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims 1
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- 230000009471 action Effects 0.000 abstract description 6
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 239000002985 plastic film Substances 0.000 description 12
- 229920006255 plastic film Polymers 0.000 description 12
- 239000000499 gel Substances 0.000 description 9
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 8
- 230000000694 effects Effects 0.000 description 8
- 239000003589 local anesthetic agent Substances 0.000 description 7
- 238000010521 absorption reaction Methods 0.000 description 5
- 210000003127 knee Anatomy 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 235000011187 glycerol Nutrition 0.000 description 3
- 230000035699 permeability Effects 0.000 description 3
- 206010002091 Anaesthesia Diseases 0.000 description 2
- 206010013786 Dry skin Diseases 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 239000004354 Hydroxyethyl cellulose Substances 0.000 description 2
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 description 2
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 description 2
- 206010036376 Postherpetic Neuralgia Diseases 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 230000037005 anaesthesia Effects 0.000 description 2
- 229960001193 diclofenac sodium Drugs 0.000 description 2
- 230000037336 dry skin Effects 0.000 description 2
- 108010025899 gelatin film Proteins 0.000 description 2
- 230000005484 gravity Effects 0.000 description 2
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- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
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- JGMJQSFLQWGYMQ-UHFFFAOYSA-M sodium;2,6-dichloro-n-phenylaniline;acetate Chemical compound [Na+].CC([O-])=O.ClC1=CC=CC(Cl)=C1NC1=CC=CC=C1 JGMJQSFLQWGYMQ-UHFFFAOYSA-M 0.000 description 2
- 239000000230 xanthan gum Substances 0.000 description 2
- 229920001285 xanthan gum Polymers 0.000 description 2
- 235000010493 xanthan gum Nutrition 0.000 description 2
- 229940082509 xanthan gum Drugs 0.000 description 2
- 229940019097 EMLA Drugs 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 239000004820 Pressure-sensitive adhesive Substances 0.000 description 1
- 206010039509 Scab Diseases 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 239000003522 acrylic cement Substances 0.000 description 1
- 238000001949 anaesthesia Methods 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
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- 238000007731 hot pressing Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
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- 210000005067 joint tissue Anatomy 0.000 description 1
- 229960004194 lidocaine Drugs 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
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- 239000007858 starting material Substances 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/025—Adhesive bandages or dressings characterised by the skin-adhering layer having a special distribution arrangement of the adhesive
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a medical covering film, a system containing the medical covering film, a using method and application of the medical covering film. The medical covering film comprises a barrier film layer, an adsorption layer and a reticular rubber layer, wherein one surface of the adsorption layer is compounded on the barrier film layer, and the reticular rubber layer is compounded on the other surface of the adsorption layer; the area of the adhesive-free area of the mesh adhesive layer accounts for more than 10% of the total area of the mesh adhesive layer and is not 100%. The using method comprises the following steps: coating the water-containing semisolid preparation on the central area of the reticular rubber layer of the medical covering film; then covering the affected part with the medical covering film, and contacting the preparation with the affected part skin, wherein the edge region of the reticular rubber layer is adhered to the skin except the affected part skin. The medical covering film can well fix the preparation on the skin of an affected part, is not easy to be extruded from a target skin area by the action of external force, and can well keep the moisture in the preparation.
Description
Technical Field
The invention relates to a medical covering film, a system containing the medical covering film, a using method and application of the medical covering film.
Background
In many disease treatment and skin nutrition applications, aqueous semisolid formulations (e.g., gels, creams) ideally need to be immobilized and enclosed on the skin surface for extended periods of time.
For example, in the management of postherpetic neuralgia, it is desirable to maintain a semisolid and aqueous (e.g., gel, cream) local anesthetic preparation on the affected skin for more than 6 hours, even more than 12 hours, to obtain a satisfactory duration of analgesic effect for the patient. During such a long period of application, the local anesthetic preparation must not flow out of the affected skin, and the volatilization of water in the local anesthetic preparation must be controlled to a certain amount or less. Otherwise, the duration of the effect of the local anesthetic will be greatly reduced.
In order to maintain the local anesthetic preparation on the skin of the affected part, there is a method of covering a layer of the local anesthetic preparation applied on the skin with a plastic film (e.g., EMLA cream for preoperative skin anesthesia, which is generally used by covering with a plastic film for 1 to 1.5 hours).
However, many times, it is necessary to keep the aqueous semisolid preparation on the affected skin for more than 6 hours or even more than 12 hours, and the method using the plastic film covering has a serious problem: (1) the plastic film has no ability to fix and adsorb the aqueous semisolid preparation, so that the covered aqueous semisolid preparation can leave the original place to be coated when being subjected to gravity or extrusion; (2) the plastic film itself has no ability to be fixed to the skin, so that it must be fixed to the skin with an additional tape; (3) the boundary of the aqueous semisolid preparation covered with the plastic film is in communication with the outside air, so that the water in the aqueous semisolid preparation is evaporated, however, when the water in the aqueous semisolid preparation is below a certain value, the transdermal absorption rate of the active ingredient may be greatly reduced. If the aqueous semisolid preparation is covered with a gel film filled with a gel, the portion of the gel film contacted with the aqueous semisolid preparation does not have the ability to adsorb the aqueous semisolid preparation, so that the aqueous semisolid preparation also leaves the affected skin by an external force such as gravity or squeezing. Therefore, it is not desirable to cover the semisolid local anesthetic formulation with a plastic film or a plastic film that is coated with glue.
Many aqueous semisolid preparations, such as some preparations for treating skin diseases, preparations for inflammation of joint muscles, and preparations for nourishing skin, are required to be fixed and sealed on the skin for a long time.
Disclosure of Invention
The technical problem to be solved by the invention is to overcome the defects that the method adopting the plastic film or the plastic film for covering in the prior art can not well fix the water-containing semisolid preparation on the skin and can not keep the water in the preparation, and provide a novel medical covering film, a system containing the medical covering film, a using method and application of the medical covering film. The medical covering film can well fix the water-containing semisolid preparation on the skin of an affected part, is not easy to extrude away from a target skin area under the action of external force, and can well keep the water in the water-containing semisolid preparation.
The invention solves the technical problems through the following technical scheme:
the invention provides a medical covering film which comprises a barrier film layer, an adsorption layer and a reticular rubber layer, wherein one surface of the adsorption layer is compounded on the barrier film, and the reticular rubber layer is compounded on the other surface of the adsorption layer; the area of the adhesive-free area of the mesh adhesive layer accounts for more than 10% of the total area of the mesh adhesive layer and is not 100%.
In the medical covering film, the barrier film layer is a barrier film conventionally used in the medical field, and the material of the barrier film can be a material which is impermeable to water vapor or has a limited water vapor permeability, such as a polyethylene film, an ethylene-vinyl acetate copolymer film (EVA film for short) or a polyurethane film.
In the medical covering film, the absorbent layer may be a material capable of absorbing or retaining a semisolid preparation containing water in the prior art, and may be, for example, a nonwoven fabric having high absorbency.
In the medical covering film, the reticular rubber layer only needs to be provided with a rubber-free area and a rubber-containing area. For example, the adhesive area of the reticular adhesive layer is an adhesive net consisting of curves and/or straight lines. Preferably, the adhesive area of the reticular adhesive layer is an adhesive net consisting of a group of parallel warps and a group of parallel wefts. More preferably, the warp and the weft are perpendicular to each other. More preferably, the distance between two adjacent warps is equal to the distance between two adjacent wefts. Still more preferably, each of the warp threads and each of the weft threads has a width of 0.5mm to 1 mm. Here, the warp threads and the weft threads on the mesh-like adhesive layer constitute adhesive regions, and the other regions of the mesh-like adhesive layer than the warp threads and the weft threads constitute adhesive-free regions.
In the medical covering film, the thickness of the mesh-like adhesive layer is preferably 0.05mm to 0.75mm, and more preferably 0.25mm to 0.75 mm.
In the medical covering film, the adhesive of the mesh adhesive layer can be a water-insoluble medical pressure-sensitive adhesive, preferably an organic silicon adhesive and/or an acrylic adhesive.
In the medical covering film, one surface of the adsorption layer can be adhered to the barrier film layer through glue, and one surface of the adsorption layer can also be compounded on the barrier film layer through hot pressing.
In the medical covering film, the reticular rubber layer can be adhered to the other surface of the adsorption layer by a spraying mode in the prior art.
In the medical covering film, preferably, the area of the adhesive-free region of the mesh-shaped adhesive layer accounts for more than 30% of the total area of the mesh-shaped adhesive layer. More preferably, the area of the non-glue area of the mesh-like glue layer accounts for more than 50% of the total area of the mesh-like glue layer. More preferably, the area of the adhesive-free region of the mesh adhesive layer accounts for more than 70% of the total area of the mesh adhesive layer, and may be, for example, 70% to 90%.
In the medical cover film, the medical cover film preferably has a length elongation of 10% or more in all directions, and may be, for example, 10% to 30%. The medical cover film having the above stretching ratio is comfortable when used in the joint muscle and the like.
The present invention also provides a system for immobilizing an aqueous semisolid formulation on the skin, said system comprising the aforementioned medical drape and a layer of aqueous semisolid formulation for application to the skin of an affected area; the medical cover film is used for covering the skin of the affected part coated with the aqueous semisolid preparation layer in a manner that the reticular gel layer faces the skin of the affected part; the central region of the network gel layer is used for contacting with the aqueous semisolid preparation layer; the edge region of the mesh-like adhesive layer is used for adhering to the skin other than the affected skin to fix the aqueous semisolid preparation layer on the skin other than the affected skin and to completely enclose the aqueous semisolid preparation layer in the enclosed space formed by the medical covering film and the skin other than the affected skin.
The system can simultaneously achieve two purposes: 1. the system enables the aqueous semisolid preparation to be in contact with the adsorption layer of the medical covering film, so that the aqueous semisolid preparation is not easy to squeeze away from a target skin area under the action of external force; 2. the medical drape of the above system covers the aqueous semisolid preparation so that it is able to retain moisture in the aqueous semisolid preparation and to fix the aqueous semisolid preparation to the skin. However, the covering materials of the prior art do not achieve the above two objectives simultaneously: if a common plastic film (i.e., a medical film coated with a plastic film) is used, the above-mentioned 2 nd object can be achieved but the above-mentioned 1 st object cannot be achieved; if gauze is used, the above 1 st object can be achieved but the above 2 nd object cannot be achieved.
In the above system, the aqueous semisolid formulation refers to a formulation that contains water and has a viscosity greater than that of water but is not completely solid. The aqueous semi-solid formulation is a gel, cream or viscous liquid; alternatively, the aqueous semi-solid formulation is a skin-nourishing formulation or a topical anesthetic formulation.
In the above system, preferably, the length of the outer edge of the medical covering film from the outer edge of the aqueous semisolid preparation layer is 5mm or more, and may be, for example, 2cm to 4 cm.
The invention also provides a using method of the medical covering film, which comprises the following steps: applying an aqueous semi-solid formulation to a central region of a network gel layer of the medical drape such that edge regions of the network gel layer are not coated by the aqueous semi-solid formulation, resulting in a medical drape with an aqueous semi-solid formulation layer; and covering the medical covering film with the water-containing semisolid preparation layer on the skin of the affected part, enabling the water-containing semisolid preparation layer to be in contact with the skin of the affected part, and enabling the edge area to be adhered to the skin outside the affected part, so that the water-containing semisolid preparation layer is fixed on the skin outside the affected part and is completely enclosed in the enclosed space formed by the medical covering film and the skin outside the affected part.
The use method can achieve the two purposes at the same time like the system. However, none of the prior art methods of use achieve both of these objectives.
In the above method of use, the aqueous semi-solid formulation is completely enclosed in the enclosed space. When the barrier film used for the barrier film layer is a material impermeable to water vapor, the water in the aqueous semisolid formulation does not evaporate, so that the water in the aqueous semisolid formulation can be well maintained. When the barrier membrane used in the barrier membrane layer has a certain water vapor permeability, the water in the water-containing semisolid preparation can evaporate, and at the moment, the water vapor permeability of the barrier membrane can be reasonably selected according to the water content in the water-containing semisolid preparation and the required use time, and the barrier membrane selected according to the principle can ensure that the transdermal absorption speed of the active ingredients in the water-containing semisolid preparation is not influenced within the required use time.
The use method can also be carried out according to the following steps: covering the medical covering film on the skin of the affected part coated with the aqueous semisolid preparation layer in such a manner that the mesh-shaped adhesive layer faces the skin of the affected part, the center region of the mesh-shaped adhesive layer being in contact with the aqueous semisolid preparation layer, and the edge region of the mesh-shaped adhesive layer being adhered to the skin other than the skin of the affected part, so as to fix the aqueous semisolid preparation layer on the skin other than the skin of the affected part and completely enclose the aqueous semisolid preparation layer in the enclosed space composed of the medical covering film and the skin other than the skin of the affected part.
Here, it should be noted that, as will be understood by those skilled in the art, when the medical cover film is used, the mesh-like glue layer of the medical cover film is directed to the skin of the affected part, and after the medical cover film is adhered to the skin other than the skin of the affected part, the medical cover film can completely cover the aqueous semisolid preparation layer, and the center region of the mesh-like glue layer is in contact with the aqueous semisolid preparation layer, and the edge region of the mesh-like glue layer which is not in contact with the aqueous semisolid preparation layer is adhered to the skin other than the skin of the affected part, so that the fixation of the aqueous semisolid preparation can be achieved.
In the above method of use, preferably, after the medical cover film is adhered to the skin other than the skin of the affected part, the length of the outer edge of the medical cover film from the outer edge of the aqueous semisolid preparation layer is 5mm or more, and may be, for example, 2cm to 4 cm.
In the above method of use, the aqueous semisolid formulation refers to a formulation that contains water and has a viscosity greater than that of water but is not completely solid. The aqueous semi-solid formulation is a gel, cream or viscous liquid; alternatively, the aqueous semi-solid formulation is a skin-nourishing formulation or a topical anesthetic formulation.
In the above system and the above method, the central area refers to an area of the mesh-like adhesive layer that is not in contact with an outer edge of the mesh-like adhesive layer, and the edge area refers to another area of the mesh-like adhesive layer that is not in the central area.
The invention also provides application of the medical covering film in preparing medical instruments for treating pain in herpes zoster stage, pain of nerve damage after herpes zoster, neuroma pain, phantom limb pain, neuralgia around diabetes, arthralgia, osteoarthritis pain, back pain, pain caused by gout, pain caused by soft tissue injury, postoperative incision pain, burn pain or pain during burn scab removal.
The positive progress effects of the invention are as follows: the invention provides a medical covering film, a system containing the medical covering film, a using method and application of the medical covering film. The medical covering film can well fix the water-containing semisolid preparation on the skin of an affected part, is not easy to extrude away from a target skin area under the action of external force, and can well keep the water in the water-containing semisolid preparation.
Drawings
Fig. 1 is a schematic structural view of each layer of the medical covering film of examples 1 to 6;
FIG. 2 is a schematic structural view of the medical coverlay of examples 1-6;
fig. 3 is a top view of a medical drape coated with a layer of aqueous semisolid formulation;
fig. 4 is a sectional view of the medical cover film coated with the aqueous semisolid formulation layer in application examples 1 to 4 in a use state.
Description of reference numerals:
Glue free area 31
Aqueous semi-solid formulation layer 40
Detailed Description
The invention is further illustrated by the following examples, which are not intended to limit the scope of the invention. The experimental methods without specifying specific conditions in the following examples were selected according to the conventional methods and conditions, or according to the commercial instructions.
TABLE 1 Material and structural parameters of medical covering film of each example
In table 1, the side length a refers to the side length of each square constituting the glue-free area 31; the ratio b is the ratio of the area of the adhesive-free region 31 to the total area of the mesh-like adhesive layer 30.
The starting materials for the aqueous semisolid formulation used in the examples below (formulation A, B, C, D) are shown in the table below and were prepared by mixing the ingredients well.
TABLE 2 raw materials for formulation A
Composition (I) | Mass percent or molar concentration |
Lidocaine | 5wt% |
Disodium hydrogen phosphate | 0.094mol/L |
Sodium dihydrogen phosphate | 0.006mol/L |
Xanthan gum | 4wt% |
Sodium hydroxide | 0.08wt% |
Water (W) | Make up to 100 wt% |
TABLE 3 raw materials for formulation B
TABLE 4 raw materials for formulation C
Composition (I) | Mass percent |
Diclofenac sodium | 2wt% |
Ethanol | 20wt% |
Hydroxyethyl cellulose | 3wt% |
Glycerol | 15wt% |
Water (W) | Make up to 100 wt% |
TABLE 5 raw materials for formulation D
Composition (I) | Mass percent |
Xanthan gum | 2wt% |
Hydroxyethyl cellulose | 3wt% |
Glycerol | 35wt% |
Water (W) | Make up to 100 wt% |
Examples 1 to 6
As shown in fig. 1 and 2, the medical covering film comprises a barrier film layer 10, an adsorption layer 20 and a mesh adhesive layer 30, wherein the adsorption layer 20 is compounded on the barrier film layer 10, and the mesh adhesive layer 30 is compounded on the adsorption layer 20.
The mesh-like adhesive layer 30 is composed of a group of parallel warps and a group of parallel wefts, wherein the warps and the wefts are perpendicular to each other, and the distance between two adjacent warps is equal to the distance between two adjacent wefts. The warp and weft threads of the mesh-like rubber layer 30 constitute the rubber-covered regions 32, and the other regions of the mesh-like rubber layer 30 except the warp and weft threads constitute the rubber-free regions 31.
Wherein, the absorption layer 20 is adhered on the barrier film layer 10 by glue, and the reticular rubber layer 30 is adhered on the absorption layer 20 by spraying.
Wherein, the material of the barrier film layer 10 and the material of the absorption layer 20, the kind of glue of the mesh-shaped glue layer 30, the thickness of the mesh-shaped glue layer 30, the ratio of the area of the glue-free region 31 of the mesh-shaped glue layer 30 to the total area of the mesh-shaped glue layer 30, and the length stretch ratio of the medical covering film in all directions are shown in table 1.
Application example 1
The method of using the medical drape of example 4 is as follows: as shown in fig. 3, a 2 mm thick layer of formulation a was applied to a 10 cm x 10 cm piece of the mesh adhesive layer 30 of the medical drape of example 4, covering a 6 cm x 6 cm area of the central area of the mesh adhesive layer 30. The medical drape with formulation a was applied to the back skin of a human subject with the formulation a and the 2cm wide peripheral area of the mesh adhesive layer 30 in direct contact with the skin, the peripheral area of the mesh adhesive layer 30 forming a flat square enclosure with the skin, and the middle 6 x 6 cm layer of formulation a (i.e., the aqueous semi-solid formulation layer 40 shown in fig. 4) enclosed in this enclosure to form the condition shown in fig. 4. Part of the formulation a in the enclosed space is absorbed by the non-woven fabric layer in the middle through the non-glue areas 31 of the web-glue layer 30, and thus fixed in place.
The technical effects are as follows: the medical covering film can well fix the formula A on the skin of an affected part during use, the skin is not easy to be extruded from a target skin area by external force, the moisture in the formula A can be well kept, the skin covered by the formula A is anesthetized after about 90 minutes, and the formula A is taken down from the skin after 24 hours of administration. The skin covered by formula a was still under anaesthesia both when and one hour after formula a was removed.
Application example 2
The method of using the medical drape of example 5 is as follows: one patient had postherpetic neuralgia on the back skin for over 8 years. The affected skin is approximately a 15 cm x 30 cm rectangle. A20 cm wide by 200 cm long roll of the medical drape of example 5 was cut 35 cm long to provide a 20 cm by 35 cm piece of medical drape. As shown in fig. 3, formulation a was applied to a central 16 cm x 31 cm area of the network layer 30 to form a 1mm thick layer. The affected skin was covered with the medical cover film with formulation A so that the affected skin was completely covered with the formulation A layer. The 2cm wide peripheral region of the adhesive network 30 directly contacts the skin and forms a flat, square enclosure with the skin, while the middle 16 cm x 31 cm layer of formulation a (i.e., the aqueous semi-solid formulation layer 40 shown in fig. 4) is enclosed within this enclosure, forming the condition shown in fig. 4. Part of the formulation a in the enclosed space is absorbed by the non-woven fabric layer in the middle through the non-glue areas 31 of the web-glue layer 30, and thus fixed in place.
The technical effects are as follows: after about 90 minutes, the patient began to experience a significant reduction in pain. The patient maintained formula a and the medical drape on the skin for 18 hours, during which 18 hours the medical drape was able to maintain moisture in formula a well, she did not leave formula a from the original application during her daily activities and sleep because most of the topical anesthetic of the formula was adsorbed by the nonwoven layer. In the next months, she repeatedly used formulations a and B in the same way and both achieved similar satisfaction.
Application example 3
The method of using the medical drape of example 3 is as follows: to alleviate the pain caused by osteoarthritis in the knee, the health care professional applied a layer of formulation C to the patient's knee to form a 15 cm wide annular band around the knee, and then covered formulation C with the medical drape of example 3 (the medical drape and formulation were secured to the skin in the edge area of the medical drape not in contact with the formulation), with formulation C (i.e., the layer 40 of the aqueous semi-solid formulation shown in FIG. 4) enclosed in the enclosed space between the medical drape and the skin. This combination of cover film and formulation C was kept on the patient's knee for 16 hours a day and was used daily.
The technical effects are as follows: the anti-inflammatory agent diclofenac sodium in formulation C was absorbed into the joint tissues through the skin. After two to three days, the patient felt significantly less pain. This is because the cover film prevents evaporation of moisture in the formulation in 16 hours of application. Furthermore, the stretchability of the cover film in all directions allows unrestricted movement of the patient's joints. The medical covering film can well fix the formula C on the skin of an affected part during use, is not easy to be extruded from a target skin area by the action of external force, and can well keep the moisture in the formula C.
Application example 4
One's arm has very dry skin at the elbow. The health care professional applies about 2 mm thick formulation D to dry skin and covers formulation D with the medical drape of examples 1-6 (the edge area of the medical drape not contacting the formulation secures the medical drape and formulation to the skin) and formulation D (i.e., the layer 40 of aqueous semi-solid formulation shown in fig. 4) is enclosed in the enclosed space formed by the medical drape and skin to the state shown in fig. 4.
The technical effects are as follows: the medical covering film can well fix the formula D containing skin moistening components such as moisture, glycerin and the like on the skin of an affected part during use, is not easy to squeeze away from a target skin area by the action of external force, and can well keep the moisture in the formula D. The patient maintained formulation D on the skin for 18 hours. The skin moistening operation is repeated once a day later by the patient, and the effect is very satisfactory.
While specific embodiments of the invention have been described above, it will be appreciated by those skilled in the art that this is by way of example only, and that the scope of the invention is defined by the appended claims. Various changes and modifications to these embodiments may be made by those skilled in the art without departing from the spirit and scope of the invention, and these changes and modifications are within the scope of the invention.
Claims (13)
1. The medical covering film is characterized by comprising a barrier film layer, an adsorption layer and a reticular rubber layer, wherein one surface of the adsorption layer is compounded on the barrier film layer, and the reticular rubber layer is compounded on the other surface of the adsorption layer; the area of the adhesive-free area of the mesh adhesive layer accounts for more than 10% of the total area of the mesh adhesive layer and is not 100%.
2. The medical drape of claim 1 wherein the barrier film of the barrier film layer is a polyethylene film, an ethylene-vinyl acetate copolymer film, or a polyurethane film;
and/or, the adsorption layer is a material capable of adsorbing or retaining the water-containing semisolid preparation, preferably a non-woven fabric;
and/or the glue area of the reticular glue layer is a glue net consisting of curves and/or straight lines;
and/or the thickness of the reticular rubber layer is 0.05mm-0.75mm, preferably 0.25mm-0.75 mm.
3. The medical drape of claim 1 wherein the adhesive areas of the reticulated adhesive layer are an adhesive mesh comprised of a set of parallel warp threads and a set of parallel weft threads; preferably, the warp and the weft are perpendicular to each other; preferably, the distance between two adjacent warp threads is equal to the distance between two adjacent weft threads; even more preferably, each of the warp threads and each of the weft threads has a width of 0.5mm to 1 mm.
4. The medical cover film of claim 1, wherein the glue of the mesh glue layer is a water-insoluble medical pressure sensitive glue, preferably a silicone glue and/or an acrylic glue.
5. The medical cover film of claim 1, wherein one side of the absorbent layer is bonded to the barrier film layer by an adhesive or one side of the absorbent layer is laminated to the barrier film layer by heat pressing; the reticular rubber layer is adhered to the other surface of the adsorption layer in a spraying mode.
6. The medical drape of claim 1 wherein the area of the adhesive-free regions of the mesh adhesive layer comprises more than 30% of the total area of the mesh adhesive layer; preferably, the area of the adhesive-free area of the mesh adhesive layer accounts for more than 50% of the total area of the mesh adhesive layer; more preferably, the area of the non-adhesive region of the mesh adhesive layer accounts for more than 70% of the total area of the mesh adhesive layer; more preferably, the area of the non-adhesive region of the mesh adhesive layer accounts for 70-90% of the total area of the mesh adhesive layer.
7. The medical coverlay of claim 1, wherein the medical coverlay has a length elongation of 10% or more in all directions; preferably, the medical covering film has a length elongation in all directions of 10% to 30%.
8. A system for fixing an aqueous semi-solid formulation on the skin, comprising a medical drape as claimed in any one of claims 1 to 7 and a layer of aqueous semi-solid formulation for application to the skin of a lesion; the medical cover film is used for covering the skin of the affected part coated with the aqueous semisolid preparation layer in a manner that the reticular gel layer faces the skin of the affected part; the central region of the network gel layer is used for contacting with the aqueous semisolid preparation layer; the edge region of the mesh-like adhesive layer is used for adhering to the skin other than the affected skin to fix the aqueous semisolid preparation layer on the skin other than the affected skin and to completely enclose the aqueous semisolid preparation layer in the enclosed space formed by the medical covering film and the skin other than the affected skin.
9. The system for immobilizing an aqueous semisolid formulation onto the skin according to claim 8, wherein the length of the outer edge of the medical cover film from the outer edge of the aqueous semisolid formulation layer is 5mm or more, preferably 2cm to 4 cm;
and/or the aqueous semisolid formulation is a gel, cream or viscous liquid, preferably a skin-nourishing formulation or a topical anesthetic formulation.
10. Method of use of the medical covering film according to any of claims 1-7, comprising the steps of: applying an aqueous semi-solid formulation to a central region of a network gel layer of the medical drape such that edge regions of the network gel layer are not coated by the aqueous semi-solid formulation, resulting in a medical drape with an aqueous semi-solid formulation layer; and covering the medical covering film with the water-containing semisolid preparation layer on the skin of the affected part, enabling the water-containing semisolid preparation layer to be in contact with the skin of the affected part, and enabling the edge area to be adhered to the skin outside the affected part, so that the water-containing semisolid preparation layer is fixed on the skin outside the affected part and is completely enclosed in the enclosed space formed by the medical covering film and the skin outside the affected part.
11. Method of use of the medical covering film according to any of claims 1-7, comprising the steps of: covering the medical covering film on the skin of the affected part coated with the aqueous semisolid preparation layer in such a manner that the mesh-shaped adhesive layer faces the skin of the affected part, the center region of the mesh-shaped adhesive layer being in contact with the aqueous semisolid preparation layer, and the edge region of the mesh-shaped adhesive layer being adhered to the skin other than the skin of the affected part, so as to fix the aqueous semisolid preparation layer on the skin other than the skin of the affected part and completely enclose the aqueous semisolid preparation layer in the enclosed space composed of the medical covering film and the skin other than the skin of the affected part.
12. The method of using medical mulch film according to claim 10 or 11 wherein the length of the outer edge of the medical mulch film away from the outer edge of the layer of aqueous semi-solid formulation is 5mm or more, preferably 2cm-4 cm.
13. Use of the medical drape of any one of claims 1-7 in the manufacture of a medical device for treating pain during herpes zoster, post-herpes zoster nerve damage pain, neuroma pain, phantom limb pain, diabetic peripheral neuralgia, joint pain, osteoarthritis pain, back pain, pain caused by gout, pain caused by soft tissue injury, post-operative incision pain, burn pain, or pain during burn decrustation.
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
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CN201910300866.7A CN111821100A (en) | 2019-04-15 | 2019-04-15 | Medical covering film, system containing same, use method and application of medical covering film |
PCT/CN2020/084858 WO2020211763A1 (en) | 2019-04-15 | 2020-04-15 | Covering film, system comprising same, and usage method and application therefor |
US17/603,014 US20220202736A1 (en) | 2019-04-15 | 2020-04-15 | Covering film, system comprising same, and usage method and application therefor |
EP20791271.8A EP3957285A4 (en) | 2019-04-15 | 2020-04-15 | Covering film, system comprising same, and usage method and application therefor |
CN202080021978.XA CN113573674A (en) | 2019-04-15 | 2020-04-15 | Cover film, system containing same, and use method and application thereof |
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CN201910300866.7A CN111821100A (en) | 2019-04-15 | 2019-04-15 | Medical covering film, system containing same, use method and application of medical covering film |
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