WO2020211763A1 - 覆盖膜、含其的系统及其使用方法、应用 - Google Patents

覆盖膜、含其的系统及其使用方法、应用 Download PDF

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Publication number
WO2020211763A1
WO2020211763A1 PCT/CN2020/084858 CN2020084858W WO2020211763A1 WO 2020211763 A1 WO2020211763 A1 WO 2020211763A1 CN 2020084858 W CN2020084858 W CN 2020084858W WO 2020211763 A1 WO2020211763 A1 WO 2020211763A1
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WO
WIPO (PCT)
Prior art keywords
layer
skin
preparation
area
covering film
Prior art date
Application number
PCT/CN2020/084858
Other languages
English (en)
French (fr)
Inventor
张洁
唐培克
Original Assignee
湖州依诺唯新药物制剂有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201920508226.0U external-priority patent/CN210644323U/zh
Priority claimed from CN201910300866.7A external-priority patent/CN111821100A/zh
Application filed by 湖州依诺唯新药物制剂有限公司 filed Critical 湖州依诺唯新药物制剂有限公司
Priority to EP20791271.8A priority Critical patent/EP3957285A4/en
Priority to US17/603,014 priority patent/US20220202736A1/en
Priority to CN202080021978.XA priority patent/CN113573674A/zh
Publication of WO2020211763A1 publication Critical patent/WO2020211763A1/zh

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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
    • A61F13/02—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
    • 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
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
    • 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
    • A61F13/0226—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0208—Tissues; Wipes; Patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A61P23/02—Local anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/007—Preparations for dry skin

Definitions

  • the invention relates to a cover film, a system containing the cover film, and a method of use and application thereof.
  • water-containing semi-solid preparations (such as gels, emulsions) ideally need to be fixed and sealed on the skin surface for a long time.
  • a semi-solid and water-containing (eg gel, cream) local anesthetic preparation on the skin of the affected area for more than 6 hours, or even more than 12 hours, to obtain The duration of the patient's satisfactory analgesic effect.
  • the local anesthetic preparation must not flow out of the skin of the affected area, and the volatilization of water in the local anesthetic preparation must be controlled below a certain amount. Otherwise, the duration of the effect of local anesthetics will be greatly reduced.
  • the existing method is to cover the local anesthetic preparation layer applied on the skin with a plastic film (such as cling film) (for example, EMLA cream for skin anesthesia before surgery, usually The method of use is to be covered by plastic film for 1-1.5 hours).
  • a plastic film such as cling film
  • the method of covering with plastic film has serious problems: (1) The plastic film does not fix and absorb the water-containing semi-solid preparation. The ability of a solid preparation, so the covered semi-solid preparation containing water will leave the place where it was originally applied when subjected to gravity or squeezing; (2) The plastic film itself does not have the ability to fix on the skin, so additional tape must be used Fix the plastic film on the skin; (3) The boundary of the water-containing semi-solid preparation covered by the plastic film is in communication with the outside air, so the water in the water-containing semi-solid preparation will evaporate.
  • the transdermal absorption rate of its active ingredients may be greatly reduced.
  • the water-containing semi-solid preparation is covered with a glue-filled film, the part of the film that is in contact with the water-containing semi-solid preparation does not have the ability to absorb the water-containing semi-solid preparation, so the water-containing semi-solid preparation is subject to external forces (such as gravity or extrusion). ) Will also leave the affected skin. Therefore, the method of covering the semi-solid local anesthetic preparation with a plastic film or a plastic film filled with glue is not ideal.
  • the technical problem to be solved by the present invention is to overcome the inability of the prior art method of covering with plastic film or plastic film to fix the water-containing semi-solid preparation on the skin, and the inability to maintain the moisture in the preparation
  • the covering film can well fix the water-containing semi-solid preparation on the skin of the affected area, is not easy to be squeezed away from the target skin area by the action of external force, and can well maintain the moisture in the water-containing semi-solid preparation.
  • the present invention provides a cover film, which includes a barrier film layer and an adsorption layer.
  • the "covering film” includes a “medical cover film”.
  • a medical cover film is used.
  • the cover film for example, a medical cover film
  • the cover film contains a crosslinking agent.
  • the crosslinking agent is preferably dispersed in the material of the adsorption layer.
  • the covering film (such as a medical covering film) contains a crosslinking agent higher than 0.01 mg/per square centimeter, more preferably higher than 0.1 mg/per square centimeter, or 0.01 mg-100 mg/per square centimeter, or 0.02-0.2mg/per square centimeter.
  • the crosslinking agent is a boron-containing substance (such as sodium borate), glutaraldehyde, glyoxal, maleic acid, citric acid, trisodium trimetaphosphate, sodium hexametaphosphate, dianhydride, Succinic acid, sulfosuccinic acid, or N,N'-methylenebisacrylamide (N,N'-methylenebisacrylamide).
  • boron-containing substance such as sodium borate
  • glutaraldehyde such as glutaraldehyde
  • glyoxal maleic acid
  • citric acid trisodium trimetaphosphate
  • sodium hexametaphosphate sodium hexametaphosphate
  • dianhydride Trisodium trimetaphosphate
  • Succinic acid sodium hexametaphosphate
  • sulfosuccinic acid or N,N'-methylenebisacrylamide (N,N'-methylenebisacrylamide).
  • the cover film for example, a medical cover film
  • the purpose is to achieve a better use effect of the cover film in the following use scenarios: the cover film covers/wraps the skin coated with a cream-like preparation layer
  • the surface layer (invasive or non-invasive), the preparation layer contains a substance that can be cross-linked (if the substance that can be cross-linked is a glue, it can be called a glue that can be cross-linked).
  • the cross-linking agent diffuses from the cover film into the preparation layer, the cross-linking agent can undergo a cross-linking reaction with the corresponding "cross-linkable substance" in the preparation layer to make the preparation
  • the layer is cured.
  • the crosslinking agent such as a substance containing boron element
  • the cross-linking reaction of the cross-linked substance causes the formulation to solidify and adhere to the cover film (such as a medical cover film).
  • the covering film for example, medical covering film
  • the preparation that has been cured and attached to the covering film for example, medical covering film
  • the crosslinking agent is a substance containing boron-containing elements, such as sodium borate; in this case, the preparation preferably contains polyvinyl alcohol.
  • the crosslinking agent is N,N'-methylene bisamide amide, and in this case, the preparation contains polyvinylpyrrolidone.
  • the covering film contains a boron-containing substance preferably higher than 0.01 mg/per square centimeter, more preferably higher than 0.1 mg/per square centimeter, or 0.01 mg -100mg/per square centimeter, or 0.02-2mg/per square centimeter; at this time, the mass percentage of polyvinyl alcohol in the preparation is preferably 0.2-30%, more preferably 0.5-15%, and still more preferably The ground is 1%-5%.
  • the cover film (such as a medical cover film) further includes a mesh glue layer, one side of the adsorption layer is compounded on the barrier film, and the mesh glue layer is compounded on the barrier film.
  • the barrier film layer is a barrier film conventionally used in the medical field, and the material of the barrier film may be a material impermeable to water vapor or a material with limited water vapor permeability, such as polyethylene Film, ethylene-vinyl acetate copolymer film (referred to as EVA film) or polyurethane film.
  • the adsorption layer may be a material capable of adsorbing or retaining a preparation in the prior art, such as a water-containing semi-solid preparation, for example, a non-woven fabric with strong absorption.
  • the net-like adhesive layer only needs to have an area without adhesive and an area with adhesive.
  • the glued area of the network glue layer is a glue net composed of curves and/or straight lines.
  • the glued area of the mesh glue layer is a glue net composed of a set of parallel warp threads and a set of parallel weft threads. More preferably, the warp threads and the weft threads are perpendicular to each other. More preferably, the distance between two adjacent warp threads is equal to the distance between two adjacent weft threads.
  • each of the warp threads and each of the weft threads is 0.5 mm-1 mm.
  • the warp threads and the weft threads on the net-like glue layer constitute areas with glue, and the other areas on the net-like glue layer except the warp threads and the weft threads constitute no glue. area.
  • the glue of the net-like glue layer may be a medical pressure-sensitive glue that is insoluble in water, preferably organic silica gel and/or acrylic glue.
  • one side of the adsorption layer can be glued to the barrier film layer, and one side of the adsorption layer can also be composited on the barrier film layer by hot pressing.
  • the network adhesive layer can be adhered to the other side of the adsorption layer by spraying in the prior art.
  • the area of the non-adhesive area of the mesh adhesive layer accounts for more than 30% of the total area of the mesh adhesive layer. More preferably, the area of the glue-free area of the network adhesive layer accounts for more than 50% of the total area of the network adhesive layer. More preferably, the area of the glue-free area of the network adhesive layer accounts for more than 70% of the total area of the network adhesive layer, for example, it may be 70%-90%.
  • the present invention also provides a system for fixing the preparation on the skin, the system comprising the aforementioned covering film (for example, a medical covering film) and a layer for coating the preparation on the skin of the affected area; the covering film (for example, Medical covering film) is used to cover the skin of the affected area coated with the preparation layer in such a way that the mesh glue layer faces the skin of the affected area; the central area of the mesh glue layer is used to The preparation layer is in contact; the edge area of the network glue layer is used to bond with the skin of the affected area or the skin outside the preparation layer, so as to fix the preparation layer on the skin of the affected area or the skin outside the affected area And the preparation layer is completely enclosed in a closed space composed of the covering film (such as a medical covering film) and the skin outside the affected area or the skin.
  • the covering film for example, Medical covering film
  • the formulation is preferably an aqueous semi-solid formulation.
  • the above system can achieve two goals at the same time: 1.
  • the above system can make the preparation (such as water-containing semi-solid preparation) contact the adsorption layer of the cover film (such as medical cover film), so that the preparation (such as water-containing semi-solid preparation) It is not easy to be squeezed away from the target skin area by external force;
  • the covering film (such as medical covering film) of the above system covers the preparation (such as a water-containing semi-solid preparation), so that the preparation (such as a water-containing semi-solid preparation) can be maintained And fix the formulations (such as water-containing semi-solid formulations) on the skin.
  • the covering material in the prior art cannot achieve the above two purposes at the same time: if a commonly used plastic film (that is, a medical film coated with glue) is used, the second objective can be achieved but the first one cannot be achieved. Purpose: If gauze is used, the first purpose above can be achieved but the second purpose above cannot be achieved.
  • the length of the outer edge of the covering film (for example, medical covering film) away from the outer edge of the preparation layer (for example, a water-containing semi-solid preparation layer) is more than 5 mm, for example, it may be 2 cm- 4cm.
  • the present invention also provides a system for fixing the formulation on the skin, the system comprising the aforementioned covering film (for example, medical covering film); wherein, the covering film (for example, medical covering film) comprises a barrier film layer and an adsorption layer, But it does not include a network glue layer; the crosslinking agent is dispersed in the material of the adsorption layer; the system also includes a preparation layer for coating the skin on the affected area; wherein the preparation contains a glue And/or substances that can be crosslinked.
  • the covering film for example, medical covering film
  • the covering film comprises a barrier film layer and an adsorption layer, But it does not include a network glue layer
  • the crosslinking agent is dispersed in the material of the adsorption layer
  • the system also includes a preparation layer for coating the skin on the affected area; wherein the preparation contains a glue And/or substances that can be crosslinked.
  • the formulation is preferably an aqueous semi-solid formulation.
  • the water-containing semi-solid preparation and “the length of the outer edge of the covering film (for example, medical covering film) away from the outer edge of the preparation layer (for example, the water-containing semi-solid preparation layer)"
  • the scheme is as described earlier.
  • cross-linkable substance when it is a glue, it can be called a cross-linkable glue.
  • the formulation contains a substance that can be crosslinked and the covering film (for example, a medical covering film) contains a corresponding crosslinking agent.
  • the covering film for example, a medical covering film
  • the material that can be cross-linked is polyvinyl alcohol, and the corresponding cross-linking agent is sodium borate.
  • the crosslinkable substance is polyvinylpyrrolidone, and the corresponding crosslinking agent is N,N'-methylenebisamide amide.
  • the cover film (for example, a medical cover film) will be fixed on the preparation layer, and no additional fixing method is required. Specifically, after the covering film (for example, a medical covering film) contacts the preparation layer, the crosslinking agent in the covering film (for example, a medical covering film) diffuses into the preparation layer and interacts with the crosslinkable substance therein. A cross-linking reaction occurs, curing the formulation layer and making the cured formulation layer adhere to the cover film (for example, a medical cover film).
  • the formulation is not completely enclosed in a closed space because the edge of the formulation layer is not sealed with the skin by the mesh glue layer in the aforementioned system.
  • the edge portion of the preparation layer for example, a water-containing semi-solid preparation layer
  • the edge portion of the preparation layer will lose part of the water contained therein due to evaporation, which may affect the absorption of the drug.
  • the decrease in drug absorption in a small part of the edge area will not affect its overall efficacy.
  • a cover film without a network glue layer (such as a medical cover film) is easier to manufacture and has a lower cost.
  • the preparation for example, an aqueous semi-solid preparation
  • the barrier film used in the barrier film layer is a material impermeable to water vapor
  • the water in the formulation such as a water-containing semi-solid formulation
  • the barrier film used in the barrier film layer has a certain water vapor permeability
  • the water in the formulation such as a water-containing semi-solid formulation
  • the method of use can also be carried out as follows: the covering film (for example, medical covering film) is covered with the preparation layer (water-containing semi-solid) in such a manner that the mesh glue layer faces the affected skin.
  • the solid preparation layer) is completely enclosed in a closed space composed of the covering film (such as a medical covering film) and the skin other than the patient's skin or the skin.
  • the covering film for example, medical covering film
  • the net-like glue layer of the covering film faces the skin of the affected area
  • the covering film for example, medical covering film
  • the covering film can completely cover the preparation layer (aqueous semi-solid preparation) Layer), and the central area of the network adhesive layer is in contact with the preparation layer (water-containing semi-solid preparation layer).
  • the edge area of the network glue layer that is not in contact with the preparation (for example, an aqueous semi-solid preparation) is adhered to the skin outside the affected area or on the skin not covered by the preparation layer, so that the preparation (for example, water-containing semi-solid preparations) fixation on the skin.
  • the preparation for example, water-containing semi-solid preparations
  • the present invention also provides a kind of the aforementioned covering film (such as medical covering film) for preparing and treating herpes zoster pain, post-herpetic 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, pain caused by incision after surgery, pain caused by skin breakage caused by disease or trauma, burn pain, or pain during burn scab removal Applications.
  • a covering film such as medical covering film
  • the present invention also provides a method of using the aforementioned system for fixing the preparation on the skin, characterized in that the preparation is applied to the skin of the affected area to form a preparation layer; and the covering film (such as a medical covering film) Cover the preparation layer until the crosslinking agent and the crosslinkable substance undergo a crosslinking reaction, so that the preparation layer is cured.
  • the covering film such as a medical covering film
  • the curing of the preparation layer includes the entire process of allowing the crosslinking agent in the cover film (for example, the medical cover film) to diffuse into the preparation layer, and cross-linking reaction with the crosslinkable substance in the preparation layer.
  • affected skin refers to the skin on the human body that is covered by the pharmaceutical preparation and can bring about therapeutic effects.
  • the skin of the affected part of shingles is the skin of the herpes area
  • the skin of the affected part of joint pain is the skin covering the joint and the vicinity of the joint
  • the skin of the affected part of the surgical incision is the skin of the surgical incision itself and nearby.
  • the positive progress effect of the present invention lies in: the present invention provides a cover film, a system containing it, and a method of use and application thereof.
  • the covering film can well fix the preparation on the skin of the affected area, is not easy to be squeezed away from the target skin area by the action of external force, and can well maintain the moisture in the preparation.
  • FIG. 1 is a schematic diagram of the structure of each layer of the medical covering film of Examples 1-6;
  • Figure 3 is a top view of a medical covering film coated with a layer of a water-containing semi-solid preparation
  • FIG. 4 is a cross-sectional view of the medical covering film coated with a water-containing semi-solid preparation layer in application examples 1-4 when in use;
  • Example 7 is a schematic diagram of the structure of the medical covering film of Example 7.
  • the side length a refers to the side length of each square constituting the glue-free area 31; the ratio b refers to the ratio of the area of the glue-free area 31 to the total area of the network adhesive layer 30.
  • the medical cover film as shown in Figures 1 and 2, the medical cover film includes a barrier film layer 10, an adsorption layer 20 and a network glue layer 30.
  • the adsorption layer 20 is compounded on the barrier film layer 10, and the network glue layer 30 is compounded on On the adsorption layer 20.
  • the mesh adhesive layer 30 is composed of a set of parallel warp threads and a set of parallel weft threads.
  • the warp threads and the weft threads are perpendicular to each other, and the distance between two adjacent warp threads is equal to the distance between two adjacent weft threads.
  • the warp and weft threads on the net-like glue layer 30 constitute a glue area 32, and the other areas on the net-like glue layer 30 except for the warp and weft constitute a glue-free area 31.
  • the adsorption layer 20 is adhered to the barrier film layer 10 by glue, and the network glue layer 30 is adhered to the adsorption layer 20 by spraying.
  • the material of the barrier film layer 10 and the material of the adsorption layer 20, the type of glue of the net-like glue layer 30, the thickness of the net-like glue layer 30, and the area of the glue-free area 31 of the net-like glue layer 30 account for the net glue layer
  • the ratio of 30 total area is shown in Table 1.
  • the raw materials of the aqueous semi-solid preparation (formulation E) used are shown in the following table, and the preparation method is to mix the components uniformly.
  • the non-woven fabric contains 0.2 mg sodium borate, 1 mg glycerin, and 1 mg maltodextrin per square centimeter (as shown in Figure 5).
  • the sodium borate in the medical covering film diffuses into the preparation layer and cross-links with the polyvinyl alcohol in the preparation, thereby making the formula E Cured and adhered to the medical cover film.
  • removing the medical covering film can simultaneously remove the formula E that has been cured and attached to the medical covering film. In this way, there is no residual water-containing semi-solid preparation on the skin, so the patient does not need to wash the skin.
  • the method of using the medical covering film of Example 4 is as follows: As shown in Fig. 3, a layer of formula A with a thickness of 2 mm is applied to a 10 cm ⁇ 10 cm mesh adhesive layer 30 of the medical covering film of Example 4 , Formulation A covers an area of 6 cm ⁇ 6 cm in the central area of the network adhesive layer 30.
  • the medical covering film with formula A was attached to the back skin of a human subject.
  • the 2 cm wide edge area around formula A and the mesh adhesive layer 30 directly touched the skin, and the edge area of the mesh adhesive layer 30 A flat square enclosed space is formed with the skin, and the middle 6 ⁇ 6 cm formula A layer (that is, the water-containing semi-solid preparation layer 40 shown in Figure 4) is enclosed in this enclosed space, forming a 4 shown in the state.
  • Part of the formula A in the closed space is absorbed by the non-woven fabric layer through the non-adhesive area 31 of the mesh adhesive layer 30, thereby being fixed in place.
  • the medical covering film can well fix formula A on the skin of the affected area during use, is not easy to be squeezed away from the target skin area by external force, and can well maintain the moisture in formula A, which is used by formula A
  • the covered skin was anesthetized about 90 minutes later, and the formula A was removed from the skin 24 hours after the start of the medication.
  • the skin covered by formula A was still anesthetized when formula A was removed and one hour after removal.
  • the method of using the medical covering film of Example 5 is as follows: a patient's back skin has suffered from herpes zoster neuralgia for more than 8 years.
  • the skin of the affected area is about 15 cm ⁇ 30 cm rectangle.
  • a roll of 20 cm wide and 200 cm long medical covering film of Example 5 was cut 35 cm long to obtain a 20 cm ⁇ 35 cm medical covering film.
  • formula A was applied on the 16 cm ⁇ 31 cm area of the central area of the mesh adhesive layer 30 to form a 1 mm thick layer.
  • Use this medical covering film with formula A to cover the skin of the affected area so that the skin of the affected area is completely covered by the formula A layer.
  • the 2 cm wide edge area around the mesh glue layer 30 directly contacts the skin and forms a flat square enclosed space with the skin, while the middle 16 cm x 31 cm formula A layer (that is, the water-containing layer shown in Figure 4)
  • the semi-solid preparation layer 40 is enclosed in this closed space, forming a state as shown in FIG. 4.
  • Part of the formula A in the closed space is absorbed by the non-woven fabric layer through the non-adhesive area 31 of the mesh adhesive layer 30, thereby being fixed in place.
  • the method of using the medical covering film of Example 3 is as follows: In order to reduce the pain caused by knee osteoarthritis, the medical staff applied a layer of formula C on the knee joint of the patient to form a 15 cm width around the knee joint Then use the medical cover film of Example 3 to cover formula C (the edge area of the medical cover film does not touch the formula to fix the medical cover film and formula on the skin), formula C (that is, as shown in Figure 4 The illustrated water-containing semi-solid preparation layer 40) is enclosed in a closed space composed of the medical covering film and the skin. The combination of this cover film and formula C is kept on the patient's knee joint for 16 hours a day and used every day.
  • the anti-inflammatory drug diclofenac sodium in formula C is absorbed into the joint tissues through the skin. After two to three days, the patient felt a significant reduction in pain. This is because in 16 hours of application, the cover film prevents evaporation of moisture in the formulation. Moreover, the stretchability of the covering film in all directions makes the movement of the patient's joints unrestricted.
  • the medical covering film can well fix the formula C on the skin of the affected area during use, is not easy to be squeezed away from the target skin area by external force, and can well maintain the moisture in the formula C.
  • a person has very dry skin on his elbows.
  • the medical staff applied formula D about 2 mm thick on dry skin, and covered the formula D with the medical covering film of Examples 1-6 (the edge area of the medical covering film did not touch the formula to fix the medical covering film and the formula on On the skin), the formula D (that is, the water-containing semi-solid preparation layer 40 shown in FIG. 4) is enclosed in the closed space composed of the medical covering film and the skin, forming the state shown in FIG.
  • the medical covering film can well fix the formula D containing moisture and glycerin and other moisturizing skin ingredients on the affected skin during use, is not easy to be squeezed away from the target skin area by external force, and can be well maintained Moisture in Formulation D.
  • the patient kept formula D on the skin for 18 hours. This patient repeats the above-mentioned skin moisturizing operation once a day, and the effect is very satisfactory.
  • the use method of the medical covering film in Example 8 is as follows: In order to reduce the pain caused by knee osteoarthritis, the medical staff applied a layer of formula G on the knee joint of the patient to form a 15 cm circumference around the knee joint. Then use the medical covering film in Example 8 to cover formula G (the edge area of the medical covering film that does not touch the formula fixes the medical covering film and the formula on the skin), and the formula G (also shown in Figure 4 The water-containing semi-solid preparation layer 40) shown in the figure is enclosed in a closed space composed of the medical covering film and the skin. The combination of this cover film and formula G is kept on the patient's knee joint for 16 hours a day and used every day.
  • formula G contains polyvinyl alcohol
  • the adsorption layer of the medical cover film contains sodium borate
  • when the medical cover film covers the formula G layer sodium borate diffuses into the formula layer and crosslinks with the polyvinyl alcohol inside.
  • the formulation G layer is cured and adhered to the medical covering film. In this way, the formula G layer will be removed at the same time when the cover film is removed, leaving no residual formula G on the skin.
  • the anti-inflammatory drug diclofenac sodium in formula G is absorbed into joint tissues through the skin. After two to three days, the patient felt a significant reduction in pain. This is because in 16 hours of application, the cover film prevents evaporation of moisture in the formulation. Moreover, the stretchability of the covering film in all directions allows the patient's joint movement without restriction.
  • the medical covering film can well fix the formula G on the skin of the affected area during use, is not easy to be squeezed away from the target skin area by external force, and can well maintain the moisture in the formula G.

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Abstract

一种医用覆盖膜、系统及其使用方法、应用。该医用覆盖膜包括屏障膜层(10)、吸附层(20)和网状胶层(30)，吸附层(20)的一面复合在屏障膜层(10)上，网状胶层(30)复合在吸附层(20)的另一面；网状胶层(30)的无胶区域(31)的面积占网状胶层(30)总面积的10％以上，且不为100％。使用方法如下：将含水的半固体制剂(40)涂覆于医用覆盖膜的网状胶层(30)的中心区域；再将医用覆盖膜覆盖患处皮肤，并使得制剂与患处皮肤接触，而网状胶层(30)的边缘区域与患处皮肤之外的皮肤粘合。该医用覆盖膜能够很好的将制剂固定在患处皮肤，不容易被外力的作用挤离靶点皮肤区域，且能够很好地保持制剂中的水分。

Description

覆盖膜、含其的系统及其使用方法、应用
本申请要求申请日为2019年4月15日的中国专利申请CN201910300866.7和CN201920508226.0的优先权。本申请引用上述中国专利申请的全文。
技术领域
本发明涉及一种覆盖膜、含其的系统及其使用方法、应用。
背景技术
在许多疾病治疗和皮肤营养的应用中，含水的半固体制剂(如凝胶，乳剂)理想地需要被固定并被封闭在皮肤表面很长时间。
比如，在控制带状疱疹后遗神经痛的过程中，需要将半固体且含水的(如凝胶，乳膏)局麻药制剂保持在患处皮肤长达6小时以上，甚至12小时以上，以获得病人满意的镇痛效果持续时间。在如此长的用药期间，局麻药制剂必须不能从患处皮肤流开，局麻药制剂中水分的挥发也必须控制在一定的量以下。否则，局麻药的效果持续时间会大大减少。
为了将局麻药制剂保持在患处皮肤，现有的方法是用塑料薄膜(如保鲜膜)覆盖住涂抹在皮肤上的局麻药制剂层(例如，用于手术前皮肤麻醉的EMLA乳膏，通常的使用方法是被塑料薄膜覆盖1-1.5小时)。
但是，很多时候，需要将含水的半固体制剂保持在患处皮肤长达6小时以上甚至12小时以上，采用塑料薄膜覆盖的方法存在很严重的问题：(1)塑料薄膜没有固定和吸附含水的半固体制剂的能力，所以被覆盖的含水的半固体制剂在受到重力作用或挤压时会离开原来涂抹的地方；(2)塑料薄膜本身没有固定在皮肤上的能力，所以，必须用另外的胶带把塑料薄膜固定在皮肤上；(3)塑料薄膜覆盖下的含水的半固体制剂的边界与外界空气相通，故含水的半固体制剂中的水分会蒸发，然而，当含水的半固体制剂中的水分低于一定的值后，其有效成分的透皮吸收速度就可能会大大下降。如果用涂满胶的胶膜覆盖含水的半固体制剂，被含水的半固体制剂接触的胶膜部分没有吸附含水的半固体制剂的能力，所以含水的半固体制剂在外力(如重力或挤压)的作用下也会离开患处皮肤。因此，采用塑料薄膜或涂满胶的塑料胶膜覆盖半固体局麻药制剂的方法的是很不理想的。
许多含水的半固体制剂，如一些治疗皮肤病的制剂，关节肌肉炎症的制剂，和营养皮肤的制剂，需要长时间地被固定和封闭在皮肤上。
发明内容
本发明要解决的技术问题是为了克服现有技术中采用塑料薄膜或塑料胶膜覆盖的方法不能够很好的将含水的半固体制剂固定在皮肤上、且不能够保持所述制剂中的水分的缺陷，而提供一种新型的覆盖膜、含其的系统及其使用方法、应用。该覆盖膜能够很好的将含水的半固体制剂固定在患处皮肤，不容易被外力的作用挤离靶点皮肤区域，且能够很好地保持含水的半固体制剂中的水分。
本发明是通过下述技术方案来解决上述技术问题：
本发明提供了一种覆盖膜，所述覆盖膜包括屏障膜层和吸附层。
本发明中，“覆盖膜”包括“医用覆盖膜”，当所述覆盖膜用于医药用途时，本领域技术人员知晓使用的是医用覆盖膜。
上述覆盖膜(例如医用覆盖膜)中，较佳地，所述覆盖膜(例如医用覆盖膜)含有交联剂。所述交联剂较佳地分散于所述吸附层的材料中。
较佳地，所述覆盖膜(例如医用覆盖膜)包含交联剂高于0.01mg/每平方厘米，更佳地高于0.1mg/每平方厘米，或0.01mg-100mg/每平方厘米，或0.02-0.2mg/每平方厘米。
较佳地，所述交联剂为含硼元素的物质(例如硼酸钠)、戊二醛、乙二醛、马来酸、柠檬酸、三偏磷酸三钠、六偏磷酸钠、二酐、丁二酸、磺基丁二酸、或N,N'-亚甲基双酰胺酰胺(N,N'-methylenebisacrylamide)。
所述覆盖膜(例如医用覆盖膜)含有交联剂时，目的在于，用于实现覆盖膜在下述使用场景具有更好的使用效果：覆盖膜覆盖/包裹涂覆有膏状的制剂层的皮肤表层(有创口或无创口)，所述制剂层含有可被交联的物质(如果可被交联的物质是胶剂，可称为可被交联的胶剂)。当所述交联剂从所述覆盖膜扩散进入所述制剂层后，所述交联剂可以与在制剂层中的相应的“可被交联的物质”发生交联反应，使所述制剂层固化。
当覆盖膜(例如医用覆盖膜)覆盖住所述制剂层后，有如下过程发生：覆盖膜中所述交联剂(如含硼元素的物质)扩散到制剂中去，引起与制剂中的可被交联的物质(如聚乙烯醇)的交联反应，从而使制剂固化并且附着在覆盖膜(例如医用覆盖膜)上。这样，当计划的给药时间结束后，揭下覆盖膜(例如医用覆盖膜)就可以同时揭下已经固化并且附在覆盖膜(例如医用覆盖膜)上的制剂。这样，皮肤上没有残留的制剂，病人也不用清洗皮肤。
较佳地，所述交联剂为含有含硼元素的物质，如硼酸钠；此时，制剂优选含有聚乙烯醇。
较佳地，所述交联剂为N,N'-亚甲基双酰胺酰胺，此时，制剂含有聚乙烯吡咯烷酮。
所述交联剂为含硼元素的物质时，所述覆盖膜包含含硼元素的物质较佳地高于0.01mg/每平方厘米，更佳地高于0.1mg/每平方厘米，或0.01mg-100mg/每平方厘米，或0.02-2mg/每平方厘米；此时，所述制剂中聚乙烯醇的质量百分比较佳地为0.2-30％，更佳地为0.5-15％，进一步更佳地为1％-5％。
上述覆盖膜(例如医用覆盖膜)中，所述覆盖膜(例如医用覆盖膜)还包括网状胶层，所述吸附层的一面复合在所述屏障膜上，所述网状胶层复合在所述吸附层的另一面；所述网状胶层的无胶区域的面积占所述网状胶层总面积的10％以上，且不为100％。
上述覆盖膜(例如医用覆盖膜)中，所述屏障膜层即为医用领域常规使用的屏障膜，所述屏障膜的材质可为不透水蒸气或有限水蒸气通透率的材料，如聚乙烯薄膜、乙烯-醋酸乙烯共聚物薄膜(简称，EVA薄膜)或聚氨酯薄膜。
上述覆盖膜(例如医用覆盖膜)中，所述吸附层可为现有技术中能够吸附或滞留制剂，例如含水的半固体制剂的材料，例如可为吸收性强的无纺布。
上述覆盖膜(例如医用覆盖膜)中，所述网状胶层只要具有无胶区域和有胶区域即可。例如，所述网状胶层的有胶区域为由曲线和/或直线组成的胶网。较佳地，所述网状胶层的有胶区域为由一组互相平行的经线和一组互相平行的纬线组成的胶网。更佳地，所述经线和所述纬线互相垂直。进一步更佳地，相邻两个经线的间距与相邻两个纬线的间距相等。再进一步更佳地，每一所述经线和每一所述纬线的宽度均为0.5mm-1mm。此处，需要说明的是，所述网状胶层上的所述经线和所述纬线构成有胶区域，所述网状胶层上除所述经线和所述纬线外的其他区域构成无胶区域。
上述覆盖膜(例如医用覆盖膜)中，所述网状胶层的厚度较佳地为0.01mm-0.75mm，更佳地为0.05mm-0.75mm，进一步更佳地为0.25mm-0.75mm。
上述覆盖膜(例如医用覆盖膜)中，所述网状胶层的胶可为不溶解于水的医用压敏胶，较佳地为有机硅胶和/或丙烯酸胶。
上述覆盖膜(例如医用覆盖膜)中，所述吸附层的一面可通过胶粘合在所述屏障膜层上，所述吸附层的一面也可通过热压复合在所述屏障膜层上。
上述覆盖膜(例如医用覆盖膜)中，所述网状胶层可通过现有技术中的喷涂的方式粘合在所述吸附层的另一面。
上述覆盖膜(例如医用覆盖膜)中，较佳地，所述网状胶层的无胶区域的面积占所述网状胶层总面积的30％以上。更佳地，所述网状胶层的无胶区域的面积占所述网状胶层总面积的50％以上。进一步更佳地，所述网状胶层的无胶区域的面积占所述网状胶层总面积的为70％以上，例如可为70％-90％。
上述覆盖膜(例如医用覆盖膜)中，较佳地，所述覆盖膜(例如医用覆盖膜)在所有方向上的长度拉伸率为10％以上，例如可为10％-30％。具有上述拉伸率的覆盖膜(例如医用覆盖膜)，在用于关节肌肉等部位时，会较为舒适。
本发明还提供一种将制剂固定在皮肤上的系统，所述系统包括前述的覆盖膜(例如医用覆盖膜)和一层用于涂覆在患处皮肤上的制剂层；所述覆盖膜(例如医用覆盖膜)用于以所述网状胶层朝向所述患处皮肤的方式覆盖在涂覆有所述制剂层的所述患处皮肤上；所述网状胶层的中心区域用于与所述制剂层接触；所述网状胶层的边缘区域用于与患处皮肤或者所述制剂层之外的皮肤粘合，以将所述制剂层固定在所述患处皮肤或者患处皮肤之外的皮肤上、并将所述制剂层完全封闭在所述覆盖膜(例如医用覆盖膜)与所述患处皮肤之外的皮肤或者皮肤组成的封闭空间内。
上述系统中，所述制剂较佳地为含水的半固体制剂。
上述系统，能够同时达到两个目的：1、上述系统能够使制剂(如含水的半固体制剂)与覆盖膜(例如医用覆盖膜)的吸附层接触，如此，制剂(如含水的半固体制剂)不容易被外力的作用挤离靶点皮肤区域；2、上述系统的覆盖膜(例如医用覆盖膜)覆盖制剂(如含水的半固体制剂)，如此，能够保持制剂(如含水的半固体制剂)中的水分并将制剂(如含水的半固体制剂)固定在皮肤上。然而，现有技术中的覆盖材料不能同时达到上述两个目的：如果用常用的塑料胶膜(也即，涂满胶的医用薄膜)，可以达到上述第2个目的但是不能达到上述第1个目的；如果用纱布，可以达到上述第1个目的但是不能达到上述第2个目的。
上述系统中，所述含水的半固体制剂指含有水分的，粘度大于水但又不完全是固体的制剂。所述含水的半固体制剂可以为凝胶、乳膏或粘滞液体；或者，所述含水的半固体制剂可以为营养皮肤的制剂或局麻药制剂。
上述系统中，较佳地，所述覆盖膜(例如医用覆盖膜)的外缘离开所述制剂层(例如含水的半固体制剂层)的外缘的长度为5毫米以上，例如可为2cm-4cm。
本发明还提供一种将制剂固定在皮肤上的系统，所述系统包括前述的覆盖膜(例如医用覆盖膜)；其中，所述覆盖膜(例如医用覆盖膜)包括屏障膜层和吸附层，但不包括网状胶层；所述交联剂分散于所述吸附层的材料中；所述系统还包括一层用于涂覆在患处皮肤上的制剂层；其中，所述制剂含有胶剂和/或可被交联的物质。
上述系统中，所述制剂较佳地为含水的半固体制剂。
“所述含水的半固体制剂”和“所述覆盖膜(例如医用覆盖膜)的外缘离开所述制剂层(例如含水的半固体制剂层)的外缘的长度”的优选和更优选的方案如前所述。
上述系统中，当所述可被交联的物质为胶剂，可称为可被交联的胶剂。
较佳地，所述制剂含有可被交联的物质而且所述覆盖膜(例如医用覆盖膜)含有相应的交联剂。
更佳地，所述可被交联的物质为聚乙烯醇，所述相应的交联剂为硼酸钠。
更佳地，所述可被交联的物质为聚乙烯吡咯烷酮，所述相应的交联剂为N,N'-亚甲基双酰胺酰胺。
由于所述制剂含有胶剂，所述覆盖膜(例如医用覆盖膜)会被固定在所述制剂层上，不需要另外固定方法。具体地，所述覆盖膜(例如医用覆盖膜)接触所述制剂层后，覆盖膜(例如医用覆盖膜)中的交联剂扩散到所述制剂层中，与其中的可被交联的物质发生交联反应，使所述制剂层固化并使固化了的制剂层粘附在所述覆盖膜(例如医用覆盖膜)上。
所以，使用这个系统时，要等待足够的时间以让所述固化过程完成。使用这个系统时，所述制剂没有被完全封闭在一个封闭空间，因为制剂层的边缘没有被前述系统中的网状胶层与皮肤密封。理论上来说，所述制剂层(例如含水的半固体制剂层)的边缘部分会由于蒸发而失去其所含的部分水分，从而可能会影响药物的吸收。但是，对于比较大面积的制剂层来说，小部分的边缘区域的药物吸收下降不会影响其总的功效。而没有网状胶层的覆盖膜(例如医用覆盖膜)更容易制造，成本更低。
本发明还提供一种前述的覆盖膜(例如医用覆盖膜)的使用方法，所述使用方法包括如下步骤：将制剂(例如含水的半固体制剂)涂覆于所述覆盖膜(例如医用覆盖膜)的网状胶层的中心区域而使得所述网状胶层的边缘区域不被所述制剂(例如含水的半固体制剂)涂覆，获得带有制剂层(例如含水的半固体制剂层)的覆盖膜(例如医用覆盖膜)；再将所述带有制剂层(例如含水的半固体制剂层)的覆盖膜(例如医用覆盖膜)覆盖在患处皮肤上，并使得所述制剂层(例如含水的半固体制剂层)与所述患处皮肤接触，所述边缘区域与患处皮肤之外或者不被制剂层(例如含水的半固体制剂层)覆盖的皮肤粘合，以将所述制剂层(例如含水的半固体制剂层)固定在所述患处皮肤或者所述患处皮肤之外的皮肤上、并将所述制剂层(例如含水的半固体制剂层)完全封闭在所述覆盖膜(例如医用覆盖膜)与所述皮肤或者所述患处皮肤之外的皮肤组成的封闭空间内。
上述使用方法如上述系统一样，能够同时达到上述两个目的。然而，现有技术中的使用方法均不能同时达到上述两个目的。
上述使用方法中，所述制剂(例如含水的半固体制剂)被完全封闭在所述封闭空间中。当所述屏障膜层所使用的屏障膜是不透水蒸气的材料，那么，所述制剂(例如含水的 半固体制剂)中的水分就不会蒸发，如此即可很好地保持制剂(例如含水的半固体制剂)中的水分。当所述屏障膜层所使用的屏障膜有一定的水蒸气通透率，所述制剂(例如含水的半固体制剂)中的水分会蒸发，此时，根据所述制剂(例如含水的半固体制剂)中的水分含量及所需的使用时间即可合理选择屏障膜的水蒸汽通透率，按照上述原则选择出的屏障膜会保证所述制剂(例如含水的半固体制剂)中的有效成分的透皮吸收速度在所需的使用时间内不受影响。
上述使用方法，所述使用方法还可按如下步骤进行：将所述覆盖膜(例如医用覆盖膜)以所述网状胶层朝向患处皮肤的方式覆盖在涂覆有制剂层(含水的半固体制剂层)的患处皮肤和周围的皮肤上，所述网状胶层的中心区域与所述制剂层(含水的半固体制剂层)接触，所述网状胶层的边缘区域与患处皮肤之外或者没有被制剂层覆盖的皮肤粘合，以将所述制剂层(含水的半固体制剂层)固定在所述患处皮肤或者患处皮肤之外的皮肤上、并将所述制剂层(含水的半固体制剂层)完全封闭在所述覆盖膜(例如医用覆盖膜)与所述患者皮肤之外的皮肤或者皮肤组成的封闭空间内。
此处，需要说明的是，本领域技术人员须知，所述覆盖膜(例如医用覆盖膜)在使用时，所述覆盖膜(例如医用覆盖膜)的网状胶层向着患处皮肤，而且所述覆盖膜(例如医用覆盖膜)与患处皮肤之外或者被制剂层覆盖处之外的皮肤粘合后，所述覆盖膜(例如医用覆盖膜)能够完全覆盖所述制剂层(含水的半固体制剂层)，且所述网状胶层的中心区域与所述制剂层(含水的半固体制剂层)接触。同时，不与所述制剂(例如含水的半固体制剂)接触的所述网状胶层的边缘区域粘合在患处皮肤之外或者没有被制剂层覆盖的皮肤上，如此可实现所述制剂(例如含水的半固体制剂)在皮肤上的固定。
上述使用方法中，较佳地，所述覆盖膜(例如医用覆盖膜)与所述患处皮肤之外或者没有被制剂层覆盖的皮肤粘合后，所述覆盖膜(例如医用覆盖膜)的外缘离开所述制剂层(含水的半固体制剂层)的外缘的距离或者长度为5毫米以上，例如可为2cm-4cm。
上述使用方法中，所述含水的半固体制剂指含有水分的，粘度大于水但又不完全是固体的制剂。所述含水的半固体制剂可为凝胶、乳膏或粘滞液体；或者，所述含水的半固体制剂可为营养皮肤的制剂或局麻药制剂。
上述系统及上述使用方法中，所述中心区域指的是所述网状胶层上不与所述制剂层相接触的区域，所述边缘区域指的是所述网状胶层上非所述中心区域的区域。
本发明还提供一种前述的覆盖膜(例如医用覆盖膜)在制备治疗带状疱疹疱疹期疼痛、带状疱疹后神经损害疼痛、神经瘤疼痛、幻肢痛、糖尿病周围神经痛、关节疼痛、骨性关节炎疼痛、背部疼痛、痛风所引起的疼痛、软组织损伤所引起的疼痛、手术后切口疼 痛、疾病或创伤引起的皮肤破损的疼痛、烧伤疼痛或烧伤去痂时的疼痛的医疗器械中的应用。
本发明还提供了一种前述的将制剂固定在皮肤上的系统的使用方法，其特征在于，将所述制剂涂抹在患处皮肤上，形成制剂层；将所述覆盖膜(例如医用覆盖膜)覆盖在所述制剂层上，直至所述交联剂和所述可被交联的物质发生交联反应，使得所述制剂层固化。
其中，所述制剂层固化包括让覆盖膜(例如医用覆盖膜)中的交联剂扩散到所述制剂层中，与制剂层中的可被交联物质发生交联反应的全部过程。
本发明中，“患处皮肤”是指被所述药物制剂覆盖能带来治疗效果的人体处的皮肤。例如，带状疱疹的患处皮肤是疱疹区域的皮肤，关节疼痛的患处皮肤是覆盖该关节和该关节附近的皮肤，手术切口的患处皮肤是手术切口本身和附近的皮肤。
本发明中，皮肤包括完整皮肤，粘膜，和疾病或创伤引起的破损的皮肤和粘膜。
本发明的积极进步效果在于：本发明提供一种覆盖膜、含其的系统及其使用方法、应用。该覆盖膜能够很好的将制剂固定在患处皮肤，不容易被外力的作用挤离靶点皮肤区域，且能够很好地保持制剂中的水分。
附图说明
图1为实施例1-6的医用覆盖膜的各层的结构示意图；
图2为实施例1-6的医用覆盖膜的结构示意图；
图3为涂覆有含水的半固体制剂层的医用覆盖膜的俯视图；
图4为应用实施例1-4中涂覆有含水的半固体制剂层的医用覆盖膜在使用状态时的剖视图；
图5为实施例7的医用覆盖膜的结构示意图。
附图标记说明：
屏障膜层 10
吸附层 20
含硼酸钠的无纺布层 201
网状胶层 30
无胶区域 31
有胶区域 32
含水的半固体制剂层 40
具体实施方式
下面通过实施例的方式进一步说明本发明，但并不因此将本发明限制在所述的实施例范围之中。下列实施例中未注明具体条件的实验方法，按照常规方法和条件，或按照商品说明书选择。
表1各实施例的医用覆盖膜的材质及结构参数
Figure PCTCN2020084858-appb-000001
表1中，边长a指的是构成无胶区域31的每一正方形的边长；比例b指的是，无胶区域31的面积占网状胶层30总面积的比例。
下述实施例中所用的含水的半固体制剂(配方A、B、C、D)的原料如下表所示，且其制备方法为将各组分混合均匀即可。
表2配方A的原料
成分 质量百分比或摩尔浓度
利多卡因 5wt％
磷酸氢二钠 0.094mol/L
磷酸二氢钠 0.006mol/L
黄原胶 4wt％
氢氧化钠 0.08wt％
水 补足至100wt％
表3配方B的原料
成分 质量百分比或摩尔浓度
布比卡因 8wt％
磷酸氢二钠 0.094mol/L
磷酸二氢钠 0.006mol/L
氢氧化钠 0.08wt％
羟乙基纤维素 3wt％
甘油 15wt％
水 补足至100wt％
表4配方C的原料
成分 质量百分比
双氯芬酸钠 2wt％
乙醇 20wt％
羟乙基纤维素 3wt％
甘油 15wt％
水 补足至100wt％
表5配方D的原料
成分 质量百分比
黄原胶 2wt％
羟乙基纤维素 3wt％
甘油 35wt％
水 补足至100wt％
表6配方F的原料
成分 质量百分比或摩尔浓度
布比卡因 8wt％
磷酸氢二钠 0.094mol/L
磷酸二氢钠 0.006mol/L
氢氧化钠 0.08wt％
羟乙基纤维素 3wt％
聚乙烯醇 10wt％
水 补足至100wt％
表7配方G的原料
成分 质量百分比
双氯芬酸钠 2wt％
乙醇 20wt％
羟乙基纤维素 3wt％
聚乙烯醇 5wt％
水 补足至100wt％
实施例1-7
如图1和图2所示的医用覆盖膜，医用覆盖膜包括屏障膜层10、吸附层20和网状胶层30，吸附层20复合在屏障膜层10上，网状胶层30复合在吸附层20上。
其中，网状胶层30由一组互相平行的经线和一组互相平行的纬线组成，经线和纬线互相垂直，且相邻两个经线的间距与相邻两个纬线的间距相等。网状胶层30上的经线和纬线构成有胶区域32，网状胶层30上除经线和纬线外的其他区域构成无胶区域31。
其中，吸附层20通过胶粘合在屏障膜层10上，网状胶层30通过喷涂的方式粘合在吸附层20上。
其中，屏障膜层10的材料和吸附层20的材料，网状胶层30的胶的种类，网状胶层30的厚度，网状胶层30的无胶区域31的面积占网状胶层30总面积的比例见表1。
实施例8
一种覆盖膜和一种含水的半固体制剂
此实施例中，所用的含水的半固体制剂(配方E)的原料如下表所示，且其制备方法 为将各组分混合均匀即可。
表8配方E的原料
成分 质量百分比或摩尔浓度
利多卡因 5％
聚乙烯醇 7.5％
氢氧化钠 0.64％
黄原胶 1.6％
水 补足至100％
医用覆盖膜的材质及结构参数均与实施例1相同，额外地，其中无纺布每平方厘米含有0.2mg硼酸钠(sodium borate)，1mg甘油，1mg麦芽糊精(如图5所示)。当所述医用覆盖膜覆盖在一层涂抹在患处皮肤的配方E后，医用覆盖膜里的硼酸钠通过扩散进入该制剂层，与该制剂中的聚乙烯醇发生交联反应，从而使配方E固化并且附着在医用覆盖膜上。这样，当计划的给药时间结束后，揭下医用覆盖膜就可以同时揭下已经固化并且附在医用覆盖膜上的配方E。这样，皮肤上没有残留的含水的半固体制剂，所以病人不用清洗皮肤。
应用实施例1
实施例4的医用覆盖膜的使用方法如下：如图3所示，将一层2毫米厚的配方A涂抹在一块10厘米×10厘米的实施例4的医用覆盖膜的网状胶层30上，配方A覆盖了网状胶层30的中心区域的6厘米×6厘米的区域。这个带有配方A的医用覆盖膜被贴在一个人类受试者的背部皮肤上，配方A和网状胶层30四周的2厘米宽的边缘区域直接接触皮肤，网状胶层30的边缘区域与皮肤一起形成一个扁的方形的封闭空间，而中间的6×6厘米配方A层(也即图4中所示的含水的半固体制剂层40)被封闭在这个封闭空间内，形成如图4所示的状态。部分在封闭空间里的配方A通过网状胶层30的无胶区域31被中间的无纺布层吸附，从而被固定在原处。
技术效果：该医用覆盖膜在使用期间能够很好的将配方A固定在患处皮肤，不容易被外力的作用挤离靶点皮肤区域，且能够很好地保持配方A中的水分，被配方A覆盖的皮肤在约90分钟后被麻醉，在开始用药24小时后，配方A被从皮肤上取下。被配方A覆盖的皮肤在配方A被取下时和取下一小时后都还是处于被麻醉的状态。
应用实施例2
实施例5的医用覆盖膜的使用方法如下：一个病人的背部皮肤已经患带状疱疹后遗神经痛8年以上。患处皮肤约为15厘米×30厘米的长方形。从一卷20厘米宽，200厘米长的实施例5的医用覆盖膜上裁剪35厘米长，得到一块20厘米×35厘米的医用覆盖膜。如图3所示，将配方A涂抹在网状胶层30的中心区域16厘米×31厘米的区域上，形成1毫米厚的一层。用这个带有配方A的医用覆盖膜覆盖患处皮肤，使患处皮肤被配方A层完全覆盖。网状胶层30四周的2厘米宽的边缘区域直接接触皮肤并与皮肤一起形成一个扁的方形的封闭空间，而中间的16厘米×31厘米配方A层(也即图4中所示的含水的半固体制剂层40)被封闭在这个封闭空间内，形成如图4所示的状态。部分在封闭空间里的配方A通过网状胶层30的无胶区域31被中间的无纺布层吸附，从而被固定在原处。
技术效果：约90分钟以后，该病人的疼痛感开始明显减轻。该病人将配方A和医用覆盖膜在皮肤上维持了18小时，在这18小时的用药期间，该医用覆盖膜能够很好地保持配方A中的水分，她的日常活动和睡觉都没有使配方A离开原来的涂抹处，因为配方层的大部分局麻药制剂被无纺布层吸附在原涂抹处。在接下来的数月中，她反复用同样方法使用了配方A和B，并且都取得了类似的满意效果。
应用实施例3
实施例3的医用覆盖膜的使用方法如下：为了减轻膝关节骨性关节炎引起的疼痛，医护人员把一层配方C涂覆在该患者的膝关节上，形成一个绕膝关节的15厘米宽的环状带，然后用实施例3的医用覆盖膜覆盖住配方C(医用覆盖膜的不接触配方的边缘区域把医用覆盖膜和配方固定在皮肤上)，配方C(也即图4中所示的含水的半固体制剂层40)被封闭在医用覆盖膜与皮肤组成的封闭空间中。此覆盖膜和配方C的组合保持在病人的膝关节上每天16小时，并且每天都使用。
技术效果：配方C中的消炎药双氯芬酸钠透过皮肤被吸收到关节组织里。两到三天以后，病人明显地感觉到了疼痛的减轻。这是因为在16个小时的应用中，所述覆盖膜防止了配方中的水分的蒸发。而且覆盖膜在所有方向上的可拉伸性使病人关节的活动不受限制。该医用覆盖膜在使用期间能够很好的将配方C固定在患处皮肤，不容易被外力的作用挤离靶点皮肤区域，且能够很好地保持配方C中的水分。
应用实施例4
一个人的手臂肘部皮肤非常干燥。医护人员把约2毫米厚的配方D涂抹在干燥的皮肤上，并用实施例1-6的医用覆盖膜覆盖住配方D(医用覆盖膜的不接触配方的边缘区 域把医用覆盖膜和配方固定在皮肤上)，配方D(也即图4中所示的含水的半固体制剂层40)被封闭在医用覆盖膜与皮肤组成的封闭空间中，形成如图4所示的状态。
技术效果：该医用覆盖膜在使用期间能够很好的将含有水分和甘油等滋润皮肤成分的配方D固定在患处皮肤，不容易被外力的作用挤离靶点皮肤区域，且能够很好地保持配方D中的水分。该病人将配方D在皮肤上保持了18小时。这位病人以后每天重复一次上述的滋润皮肤操作，效果非常满意。
应用实施例5
实施例8中的医用覆盖膜的使用方法如下：为了减轻膝关节骨性关节炎引起的疼痛，医护人员把一层配方G涂覆在该患者的膝关节上，形成一个绕膝关节的15厘米宽的环状带，然后用实施例8中的医用覆盖膜覆盖住配方G(医用覆盖膜的不接触配方的边缘区域把医用覆盖膜和配方固定在皮肤上)，配方G(也即图4中所示的含水的半固体制剂层40)被封闭在医用覆盖膜与皮肤组成的封闭空间中。此覆盖膜和配方G的组合保持在病人的膝关节上每天16小时，并且每天都使用。由于配方G中含有聚乙烯醇，而且该医用覆盖膜的吸附层中含有硼酸钠，当该医用覆盖膜覆盖配方G层时，硼酸钠通过扩散进入配方层，与里面的聚乙烯醇发生交联反应，使配方G层固化并粘附在该医用覆盖膜上。这样，取下覆盖膜时会同时取下配方G层，不留残余的配方G在皮肤上。
技术效果：配方G中的消炎药双氯芬酸钠透过皮肤被吸收到关节组织里。两到三天以后，病人明显地感觉到了疼痛的减轻。这是因为在16个小时的应用中，所述覆盖膜防止了配方中的水分的蒸发。而且覆盖膜在所有方向上的可拉伸性使病人关节的活动不受限制。该医用覆盖膜在使用期间能够很好的将配方G固定在患处皮肤，不容易被外力的作用挤离靶点皮肤区域，且能够很好地保持配方G中的水分。
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这仅是举例说明，本发明的保护范围是由所附权利要求书限定的。本领域的技术人员在不背离本发明的原理和实质的前提下，可以对这些实施方式做出多种变更或修改，但这些变更和修改均落入本发明的保护范围。

Claims (14)

  1. 一种覆盖膜，其特征在于，所述覆盖膜包括屏障膜层和吸附层。
  2. 如权利要求1所述的覆盖膜，其特征在于，所述覆盖膜为医用覆盖膜。
  3. 如权利要求1或2所述的覆盖膜，其特征在于，所述覆盖膜含有交联剂；所述交联剂较佳地分散于所述吸附层的材料中；
    较佳地，所述覆盖膜包含交联剂高于0.01mg/每平方厘米，更佳地高于0.1mg/每平方厘米，或0.01mg-100mg/每平方厘米，或0.02mg-2mg/每平方厘米；
    较佳地，所述交联剂为含硼元素的物质、戊二醛、乙二醛、马来酸、柠檬酸、三偏磷酸三钠、六偏磷酸钠、二酐、丁二酸、磺基丁二酸、或N,N'-亚甲基双酰胺酰胺；所述含硼元素的物质较佳地为硼酸钠；
    更佳地，所述覆盖膜包含含硼元素的物质高于0.01mg/每平方厘米，进一步更佳地高于0.1mg/每平方厘米，或0.01mg-100mg/每平方厘米，或0.02mg-2mg/每平方厘米。
  4. 如权利要求1-3任一项中所述的覆盖膜，其特征在于，所述覆盖膜还包括网状胶层，所述吸附层的一面复合在所述屏障膜上，所述网状胶层复合在所述吸附层的另一面；所述网状胶层的无胶区域的面积占所述网状胶层总面积的10％以上，且不为100％；
    或者，所述医用覆盖膜还包括网状胶层，所述吸附层的一面复合在所述屏障膜上，所述网状胶层复合在所述吸附层的另一面；所述网状胶层的无胶区域的面积占所述网状胶层总面积的10％以上，且不为100％。
  5. 如权利要求1-4任一项中所述的覆盖膜，其特征在于，所述屏障膜层的屏障膜的材质为聚乙烯薄膜、乙烯-醋酸乙烯共聚物薄膜或聚氨酯薄膜；
    和/或，所述吸附层为能够吸附或滞留含水的半固体制剂的材料，较佳地为无纺布；
    和/或，所述网状胶层的有胶区域为由曲线和/或直线组成的胶网；
    和/或，所述网状胶层的厚度为0.01mm-0.75mm，较佳地为0.05mm-0.75mm，更佳地为0.25mm-0.75mm；
    和/或，所述网状胶层的有胶区域为由一组互相平行的经线和一组互相平行的纬线组成的胶网；较佳地，所述经线和所述纬线互相垂直；更佳地，相邻两个所述经线的间距与相邻两个所述纬线的间距相等；进一步更佳地，每一所述经线和每一所述纬线的宽度均为0.5mm-1mm；
    和/或，所述网状胶层的胶为不溶解于水的医用压敏胶，较佳地为有机硅胶和/或丙烯酸胶；
    和/或，所述吸附层的一面通过胶粘合在所述屏障膜层上或者所述吸附层的一面通过热压复合在所述屏障膜层上；所述网状胶层通过喷涂的方式粘合在所述吸附层的另一面；
    和/或，所述网状胶层的无胶区域的面积占所述网状胶层总面积的30％以上；较佳地，所述网状胶层的无胶区域的面积占所述网状胶层总面积的50％以上；更佳地，所述网状胶层的无胶区域的面积占所述网状胶层总面积的为70％以上；进一步更佳地，所述网状胶层的无胶区域的面积占所述网状胶层总面积的为70％-90％。
  6. 如权利要求1所述的覆盖膜，其特征在于，所述覆盖膜在所有方向上的长度拉伸率为10％以上；较佳地，所述覆盖膜在所有方向上的长度拉伸率为10％-30％；
    或者，所述医用覆盖膜在所有方向上的长度拉伸率为10％以上；较佳地，所述医用覆盖膜在所有方向上的长度拉伸率为10％-30％。
  7. 一种将制剂固定在皮肤上的系统，其特征在于，所述系统包括如权利要求1-6任一项所述的覆盖膜和一层用于涂覆在患处皮肤上的制剂层；
    所述覆盖膜用于以所述网状胶层朝向所述患处皮肤的方式覆盖在涂覆有所述制剂层的所述患处皮肤上；所述网状胶层的中心区域用于与所述制剂层接触；所述网状胶层的边缘区域用于与患处皮肤或者所述制剂层之外的皮肤粘合，以将所述制剂层固定在所述患处皮肤或者患处皮肤之外的皮肤上、并将所述制剂层完全封闭在所述医用覆盖膜与所述患处皮肤之外的皮肤或者皮肤组成的封闭空间内；
    或者，所述医用覆盖膜用于以所述网状胶层朝向所述患处皮肤的方式覆盖在涂覆有所述制剂层的所述患处皮肤上；所述网状胶层的中心区域用于与所述制剂层接触；所述网状胶层的边缘区域用于与患处皮肤或者所述制剂层之外的皮肤粘合，以将所述制剂层固定在所述患处皮肤或者患处皮肤之外的皮肤上、并将所述制剂层完全封闭在所述医用覆盖膜与所述患处皮肤之外的皮肤或者皮肤组成的封闭空间内。
  8. 一种将制剂固定在皮肤上的系统，其特征在于，所述系统包括如权利要求1-6任一项所述的覆盖膜；
    其中，所述覆盖膜包括屏障膜层和吸附层，但不包括网状胶层；所述交联剂分散于所述吸附层的材料中；所述系统还包括一层用于涂覆在患处皮肤上的制剂层；其中，所述制剂含有胶剂和/或可被交联的物质；较佳地，所述制剂含有可被交联的物质而且所述覆盖膜含有相应的交联剂；
    或者所述医用覆盖膜包括屏障膜层和吸附层，但不包括网状胶层；所述交联剂分散于所述吸附层的材料中；所述系统还包括一层用于涂覆在患处皮肤上的制剂层；其中，所述制剂含有胶剂和/或可被交联的物质；较佳地，所述制剂含有可被交联的物质而且医 用覆盖膜含有相应的交联剂；
    更佳地，所述可被交联的物质为聚乙烯醇，所述相应的交联剂为硼酸钠；
    进一步更佳地，所述制剂中聚乙烯醇的质量百分比为0.2-30％，较佳地为0.5-15％，更佳地为1％-5％；
    更佳地，所述可被交联的物质为聚乙烯吡咯烷酮，所述相应的交联剂为N,N'-亚甲基双酰胺酰胺。
  9. 如权利要求7或8所述的系统，其特征在于，所述制剂为含水的半固体制剂；
    较佳地，所述含水的半固体制剂为凝胶、乳膏或粘滞液体，较佳地为营养皮肤的制剂或局麻药制剂；
    和/或，所述覆盖膜的外缘离开所述含水的半固体制剂层的外缘的长度为5毫米以上，较佳地为2cm-4cm；或者，所述医用覆盖膜的外缘离开所述含水的半固体制剂层的外缘的长度为5毫米以上，较佳地为2cm-4cm。
  10. 一种如权利要求1-6任一项所述的覆盖膜的使用方法，其特征在于，所述使用方法包括如下步骤：将制剂涂覆于所述覆盖膜的网状胶层的中心区域而使得所述网状胶层的边缘区域不被所述制剂涂覆，获得带有制剂层的覆盖膜；再将所述带有制剂层的覆盖膜覆盖在患处皮肤上，并使得所述制剂层与所述患处皮肤接触，所述边缘区域与或者不被制剂层覆盖的皮肤粘合，以将所述制剂层固定在所述患处皮肤或者所述患处皮肤之外的皮肤上、并将所述制剂层完全封闭在所述覆盖膜与所述皮肤或者所述患处皮肤之外的皮肤组成的封闭空间内；
    或者，所述使用方法包括如下步骤：将制剂涂覆于所述医用覆盖膜的网状胶层的中心区域而使得所述网状胶层的边缘区域不被所述制剂涂覆，获得带有制剂层的医用覆盖膜；再将所述带有制剂层的医用覆盖膜覆盖在患处皮肤上，并使得所述制剂层与所述患处皮肤接触，所述边缘区域与或者不被制剂层覆盖的皮肤粘合，以将所述制剂层固定在所述患处皮肤或者所述患处皮肤之外的皮肤上、并将所述制剂层完全封闭在所述医用覆盖膜与所述皮肤或者所述患处皮肤之外的皮肤组成的封闭空间内；
    较佳地，所述制剂为含水的半固体制剂，所述制剂层为含水的半固体制剂层。
  11. 如权利要求10所述的覆盖膜的使用方法，其特征在于，所述使用方法包括如下步骤：将所述覆盖膜以所述网状胶层朝向患处皮肤的方式覆盖在涂覆有制剂层的患处皮肤和周围的皮肤上，所述网状胶层的中心区域与所述制剂层接触，所述网状胶层的边缘区域与患处皮肤之外或者没有被制剂层覆盖的皮肤粘合，以将所述制剂层固定在所述患处皮肤或者患处皮肤之外的皮肤上、并将所述制剂层完全封闭在所述覆盖膜与所述患者皮 肤之外的皮肤或者皮肤组成的封闭空间内；
    或者，将所述医用覆盖膜以所述网状胶层朝向患处皮肤的方式覆盖在涂覆有制剂层的患处皮肤和周围的皮肤上，所述网状胶层的中心区域与所述制剂层接触，所述网状胶层的边缘区域与患处皮肤之外或者没有被制剂层覆盖的皮肤粘合，以将所述制剂层固定在所述患处皮肤或者患处皮肤之外的皮肤上、并将所述制剂层完全封闭在所述医用覆盖膜与所述患者皮肤之外的皮肤或者皮肤组成的封闭空间内；
    较佳地，所述制剂为含水的半固体制剂，所述制剂层为含水的半固体制剂层。
  12. 如权利要求10或11所述的覆盖膜的使用方法，其特征在于，所述覆盖膜的外缘离开所述含水的半固体制剂层或者所述制剂层的外缘的长度为5毫米以上，较佳地为2cm-4cm；
    或者，所述医用覆盖膜的外缘离开所述含水的半固体制剂层或者所述制剂层的外缘的长度为5毫米以上，较佳地为2cm-4cm。
  13. 一种如权利要求1-6任一项中所述的覆盖膜在制备治疗带状疱疹疱疹期疼痛、带状疱疹后神经损害疼痛、神经瘤疼痛、幻肢痛、糖尿病周围神经痛、关节疼痛、骨性关节炎疼痛、背部疼痛、痛风所引起的疼痛、软组织损伤所引起的疼痛、手术后切口疼痛、疾病或创伤引起的皮肤破损的疼痛、烧伤疼痛或烧伤去痂时的疼痛的医疗器械中的应用；所述覆盖膜例如为医用覆盖膜。
  14. 一种如权利要求7-9任一项中所述的将制剂固定在皮肤上的系统的使用方法，其特征在于，将所述制剂涂抹在患处皮肤上，形成制剂层；将所述覆盖膜或者所述医用覆盖膜覆盖在所述制剂层上；直至所述交联剂和所述可被交联的物质发生交联反应，使得所述制剂层固化。
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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060193900A1 (en) * 2005-02-28 2006-08-31 Hisamitsu Pharmaceutical Co., Inc. Pressure sensitive adhesive and patch
CN102327161A (zh) * 2011-06-16 2012-01-25 安美得生医股份有限公司 创伤敷料的制备工艺
CN102600013A (zh) * 2012-03-21 2012-07-25 苏州博创同康生物工程有限公司 一种医用植绒止血材料及其制备和应用
CN103596560A (zh) * 2010-11-09 2014-02-19 张洁 薄层和液体结合的透皮给药系统
US20140336557A1 (en) * 2013-05-10 2014-11-13 Biovation Ii, Llc Biopolymer multi-layer multi-functional medical dressing and method of making same
CN108030592A (zh) * 2017-12-15 2018-05-15 温州市人民医院 一种易撕医用胶布
CN108420605A (zh) * 2018-04-19 2018-08-21 葛纪宏 一种自带内生拉力、应力的医用功能敷料

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6673363B2 (en) * 1999-12-16 2004-01-06 Dermatrends, Inc. Transdermal and topical administration of local anesthetic agents using basic enhancers
US20060105029A1 (en) * 2004-11-12 2006-05-18 Jie Zhang Instant patch for dermal drug delivery
DE102011013920A1 (de) * 2011-03-14 2012-09-20 Wolfgang Winkelmann Medizinische Hautabdeckung zur Behandlung von Infektionen der Haut
CN103930102B (zh) * 2011-08-25 2016-08-24 尼普洛外用药品株式会社 含水贴剂
WO2013169906A1 (en) * 2012-05-08 2013-11-14 Jie Zhang Sheet and liquid combination systems for dermal delivery of lidocaine, diclofenac, and other drugs
CN203693902U (zh) * 2013-10-25 2014-07-09 稳健实业(深圳)有限公司 一种硅凝胶泡沫敷贴
CN207708089U (zh) * 2017-03-27 2018-08-10 华中科技大学同济医学院附属协和医院 湿敷敷料及医疗用品
CN208598642U (zh) * 2017-11-10 2019-03-15 山东大正医疗器械股份有限公司 一种创口敷贴

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060193900A1 (en) * 2005-02-28 2006-08-31 Hisamitsu Pharmaceutical Co., Inc. Pressure sensitive adhesive and patch
CN103596560A (zh) * 2010-11-09 2014-02-19 张洁 薄层和液体结合的透皮给药系统
CN102327161A (zh) * 2011-06-16 2012-01-25 安美得生医股份有限公司 创伤敷料的制备工艺
CN102600013A (zh) * 2012-03-21 2012-07-25 苏州博创同康生物工程有限公司 一种医用植绒止血材料及其制备和应用
US20140336557A1 (en) * 2013-05-10 2014-11-13 Biovation Ii, Llc Biopolymer multi-layer multi-functional medical dressing and method of making same
CN108030592A (zh) * 2017-12-15 2018-05-15 温州市人民医院 一种易撕医用胶布
CN108420605A (zh) * 2018-04-19 2018-08-21 葛纪宏 一种自带内生拉力、应力的医用功能敷料

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3957285A4

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