Film product and oral film product
By setting a sheet layer in the film agent product to improve tension, the problem of dissolution, shrinkage, deformation or adhesion of the film agent product when it fails to reach the target position is solved, and the stability and use effect of the product are improved.
Patent Information
- Application Number
- CN202411999617.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-31
- Publication Date
- 2025-06-03
AI Technical Summary
Film agent products are prone to dissolve, shrink, deform or stick when they fail to reach the target position, affecting the use effect.
By setting a sheet in the film agent product, it increases its tension and delays dissolution and deformation caused by liquid contact, ensuring that the product does not disintegrate quickly after reaching the target position.
Effectively prevent the film agent product from shrinking, deformation, adhesion and other problems during use, ensure its integrity and effectiveness in the target position, and reduce the cost of use.
Smart Images

Figure CN120078747A_ABST
Abstract
Description
Technical Field
[0001] This application relates to the technical field of film products, specifically to film products and oral film products. Background Art
[0002] Due to advantages such as convenient use, light weight, local effect, fast onset, and high efficiency, film products have received extensive attention and have gradually moved from simple pharmaceuticals to various consumer and health care product scenarios. When users use film products, they usually directly hold the film product and then use their fingers to place or attach it to the target position. During this process, once the film product comes into contact with liquids such as sweat and saliva, it will absorb moisture and start releasing active ingredients, resulting in the film product dissolving, or wrinkling, deforming, or sticking before reaching the target position, which greatly affects the use effect of the film product. Summary of the Invention
[0003] The present invention aims to solve to a certain extent one of the technical problems in the related art, such as the film product dissolving before reaching the target position, the film product being prone to wrinkling, deforming, sticking and being difficult to attach to the target position, and the film product rapidly disintegrating after contacting a liquid. For this purpose, the present invention provides a film product and an oral film product that are not easily wrinkled or deformed, not easily adhered or stuck, can control the release rate of active ingredients, or are easy to package and store.
[0004] In the first aspect of this application, a film product is provided. According to an embodiment of this application, the film product includes: a functional film layer containing active ingredients, the active ingredients being adapted to be released from the functional film layer and act on the target position; a sheet layer, the sheet layer including a first sheet layer, the first sheet layer being disposed on at least a part of the surface of the functional film layer; and / or, the first sheet layer is embedded in the functional film layer. Specifically, by providing the sheet layer, the tensile strength of the film product can be improved, and the problem of the film product being prone to wrinkling and deforming can be improved by using the sheet layer that can maintain its shape for a long time, reducing the degree of deformation of the film product before reaching the target position; at the same time, due to the increase in tensile strength, the film product will no longer rapidly disintegrate after being placed at the target position, and the effect of withdrawing a relatively complete film product from the target position during use can be achieved; it can also effectively improve the situation where the film product rapidly deforms, adheres, breaks or disintegrates when contacting a liquid, making it difficult to be placed at the target position. During the placement process, the film product can be moved by the user multiple times until it is aligned with the target position, and basically one film product can be attached to the target position, significantly reducing the use cost of the film product.
[0005] According to an embodiment of this application, the first sheet layer covers one surface of the functional film layer.
[0006] According to an embodiment of the present application, the sheet further includes a second sheet, and the first sheet and the second sheet are disposed on two opposite surfaces of the functional film layer.
[0007] According to an embodiment of the present application, the edges of at least two of the first sheet, the functional film layer, and the second sheet are aligned.
[0008] According to an embodiment of the present application, partial edges of the first sheet and the second sheet are connected to each other to jointly form a first bag-like structure having an opening on at least one side. A first accommodation space is provided in the first bag-like structure, and at least a part of the functional film layer is disposed in the first accommodation space.
[0009] According to an embodiment of the present application, the edges of the first sheet and the second sheet are connected to each other to jointly form a second bag-like structure having no opening at the edge. A second accommodation space is provided in the second bag-like structure, and the functional film layer is accommodated in the second accommodation space.
[0010] According to an embodiment of the present application, at least one of the first sheet and the second sheet is provided with a through hole.
[0011] According to an embodiment of the present application, the first sheet includes a plurality of first sub-sheets stacked on each other.
[0012] According to an embodiment of the present application, the second sheet includes a plurality of second sub-sheets stacked on each other.
[0013] By different sheet setting methods, the requirements of different usage scenarios can be met, providing a more diverse experience.
[0014] According to an embodiment of the present application, the adjacent first sub-sheets are detachably connected; and / or the adjacent second sub-sheets are detachably connected.
[0015] According to an embodiment of the present application, the first sub-sheet is provided with a first disassembly portion.
[0016] According to an embodiment of the present application, partial edges of two connected first sub-sheets are not sealed.
[0017] According to an embodiment of the present application, the second sub-sheet is provided with a second disassembly portion.
[0018] According to an embodiment of the present application, partial edges of two connected second sub-sheets are not sealed.
[0019] According to an embodiment of the present application, the first sheet includes a first detachable area and a first non-detachable area, and the first detachable area and the first non-detachable area are connected by a first weak connection structure.
[0020] According to an embodiment of the present application, the second sheet layer includes a second detachable area and a second non-detachable area, and the second detachable area and the second non-detachable area are connected by a second weak connection structure.
[0021] Specifically, through the detachable connection, the user can adjust the number of sheet layers according to their own experience during actual use. For example, different stimulation intensities can be selected, so as to better meet the usage requirements of different users.
[0022] According to an embodiment of the present application, the film agent product further includes: a waterproof layer.
[0023] In some embodiments, the film agent product includes a functional film layer and a first sheet layer, and the waterproof layer is disposed on the surface of the first sheet layer away from the functional film layer or on the surface of the functional film layer not covered by the first sheet layer.
[0024] In some embodiments, the film agent product includes a functional film layer, a first sheet layer, and a second sheet layer. The functional film layer is sandwiched between the first sheet layer and the second sheet layer, and the waterproof layer is disposed on the surface of the first sheet layer away from the functional film layer, on the surface of the second sheet layer away from the functional film layer, or on the surface of the functional film layer not covered by the first sheet layer and the second sheet layer.
[0025] By providing the waterproof layer, the delivery of the active ingredient released from the functional film layer to non-target positions can be reduced. For example, it can enter the digestive tract through the oral cavity, and promote the active ingredient released from the functional film layer to act through the side facing the target position, so that more active ingredient can be absorbed by the target position.
[0026] According to an embodiment of the present application, the film agent product further includes: a water-swellable substance, and the water-swellable substance is disposed on at least one of the following positions: the surface of the first sheet layer, the surface of the second sheet layer, the pores of the first sheet layer, and the pores of the second sheet layer. After the water-swellable substance absorbs water and swells, the overall tensile strength of the film agent product can be improved, which is convenient for the user to move the film agent product and improves the usability of the film agent product.
[0027] According to an embodiment of the present application, the first sheet layer and the second sheet layer are the same.
[0028] According to an embodiment of the present application, at least one of the water permeability, porosity, thickness, material, tensile strength, and number of layers of the first sheet layer and the second sheet layer is different. Thus, different release rates of the active ingredient can be provided on both surfaces of the film agent product, enriching the user experience and meeting the personalized usage requirements of more usage scenarios and more users.
[0029] According to an embodiment of the present application, the first sheet layer and the second sheet layer each independently have water permeability; or do not have water permeability and are provided with water-permeable channels. Thus, it can effectively facilitate the active ingredient in the functional film layer to act on the target position.
[0030] According to an embodiment of the present application, the water-permeable channel includes a through-hole, or the water-permeable channel includes a through-hole and a porous layer detachably disposed on the through-hole.
[0031] According to an embodiment of the present application, the first sheet layer and the second sheet layer each independently include at least one of non-woven fabric, special paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh cloth, foamed resin film, reticular resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet provided with a water-permeable channel, and rubber sheet provided with a water-permeable channel.
[0032] According to an embodiment of the present application, the functional film layer includes a plurality of sub-functional film layers. In some embodiments, the plurality of sub-functional film layers are the same. Specifically, when the thickness of a single functional film layer is limited, a greater thickness and a greater dose of active ingredient can be achieved by providing a plurality of sub-functional film layers. In other embodiments, at least one of the types and concentrations of active ingredients contained in the plurality of sub-functional film layers is different. Thus, a variety of different active ingredients or active ingredients with different concentrations can be combined and used in a film product, realizing a flexible combination between the types of active ingredients and the concentrations of active ingredients, and providing a richer experience for customers.
[0033] In some embodiments, the sub-functional film layer includes at least one of a first sub-functional film layer and a second sub-functional film layer, and a plurality of first sub-functional film layers are stacked, and / or a plurality of second sub-functional film layers are arranged in a tiled manner on the first surface.
[0034] According to an embodiment of the present application, the adjacent first sub-functional film layers are detachably connected; and / or the second sub-functional film layer and the sheet layer are detachably connected. Thus, the user can flexibly adjust the types and quantities of the sub-functional film sheets according to personal actual needs, better meeting the personalized needs of the user.
[0035] According to an embodiment of the present application, the first sub-functional film layer is provided with a third disassembly portion.
[0036] According to an embodiment of the present application, partial edges of two connected first sub-functional film layers are unsealed.
[0037] According to an embodiment of the present application, the second sub-functional film layer is provided with a fourth disassembly portion.
[0038] According to an embodiment of the present application, partial edges of the second sub-functional film layer and the sheet layer are unsealed.
[0039] According to an embodiment of the present application, the first layer includes a plurality of third sub-layers, the plurality of third sub-layers are substantially parallel to the first surface, and the orthographic projection of each third sub-layer on the first surface overlaps with the orthographic projection of at least one second sub-functional film layer on the first surface; at least one of the water permeability, material, porosity, tensile strength, thickness, and number of layers of the plurality of third sub-layers is different. Thus, different second sub-functional film layers can have different active ingredient release rates, better meeting user needs and enriching the user experience.
[0040] According to an embodiment of the present application, the layer further includes at least one third layer, and the third layer is sandwiched between two adjacent first sub-functional film layers
[0041] According to an embodiment of the present application, at least one of the water permeability, material, porosity, thickness, tensile strength, and number of layers of the plurality of third layers is different.
[0042] According to an embodiment of the present application, the film product further includes a holding portion. The user can hold the holding portion by hand to attach the film product to the target position or take it out midway, improving the usability of the film product.
[0043] According to an embodiment of the present application, the holding portion includes at least one of a traction line and a handle.
[0044] According to an embodiment of the present application, the holding portion is located at the edge of the film product.
[0045] According to an embodiment of the present application, the holding portion includes a part of the layer.
[0046] According to an embodiment of the present application, the holding portion includes a part of the layer and a part of the functional film layer.
[0047] According to an embodiment of the present application, graphic information is printed on the film product. Thus, it is convenient for users to identify graphic information, brand information, etc., making it more convenient to use.
[0048] According to an embodiment of the present application, the film product includes at least one of an oral buccal film product, a sublingual film product, a supra-lingual film product, an oral mucosa film product, a gingival film product, a dental patch product, a nasal cavity film product.
[0049] According to an embodiment of the present application, the outer contour shape of the film product includes at least one of a square, a rectangle, a circle, a triangle, a polygon, and an irregular shape.
[0050] According to an embodiment of the present application, the maximum size of the outer contour of the film product is 0.1 cm to 8 cm, and the minimum size is 0.1 cm to 1.5 cm. In some embodiments, the maximum size of the film product is 0.8 cm to 3 cm, and the minimum size is 0.6 cm to 1.2 cm.
[0051] According to an embodiment of the present application, the functional film layer includes at least one of a completely dissolved film layer, a partially dissolved film layer, and a swelling film layer.
[0052] According to an embodiment of the present application, the active ingredient includes at least one of a pharmaceutical ingredient, a nutraceutical ingredient, a food ingredient, a daily chemical ingredient, and an alkaloid.
[0053] According to an embodiment of the present application, the pharmaceutical ingredient includes at least one of an oral ulcer drug, a psychiatric drug, an analgesic, an anti-inflammatory drug, cannabinoids and their derivatives, a nasal drug, a respiratory drug, and sildenafil.
[0054] According to an embodiment of the present application, the nutraceutical ingredient includes at least one of American ginseng extract, Schisandra chinensis extract, Ganoderma lucidum extract, arginine, propolis, melatonin, glutathione, and taurine.
[0055] According to an embodiment of the present application, the food ingredient includes at least one of tea extract, coffee extract, and vitamins.
[0056] According to an embodiment of the present application, the daily chemical ingredient includes at least one of papain, catalase, a tooth whitening ingredient, an oral repair ingredient, and an anti-aging ingredient.
[0057] According to an embodiment of the present application, the alkaloid includes at least one of nicotine and its derivatives, caffeine and its analogs, arecoline and its analogs, and hexamethyl nicotine.
[0058] Thus, the film agent product has a wide range of uses, can play different roles, and meet the usage requirements of different usage scenarios.
[0059] In the second aspect of the present application, an oral film product is provided. According to an embodiment of the present application, the oral film product includes: an oral film containing an active ingredient, which is adapted to be released from the oral film and act on a target position; a sheet material, the sheet material includes a first sheet material, and the first sheet material is disposed on at least a part of the surface of the oral film; and / or, the first sheet material is embedded inside the oral film, wherein the sheet material may be the same as the sheet layer described above, and the oral film may be the same as the functional film layer described above. Specifically, by providing the sheet material, the tensile strength of the oral film product can be improved, and the problem that the oral film product is prone to wrinkling and deformation can be improved by using the sheet material that can maintain its shape for a long time, and the degree of deformation of the oral film product before reaching the target position can be reduced; at the same time, the oral film product will not disintegrate quickly after being placed at the target position, and the effect of facilitating the withdrawal of the oral film product from the target position during use can be achieved; it can also effectively improve the situation that the oral film product comes into contact with liquid and quickly deforms, adheres, breaks or disintegrates, resulting in difficulty in fitting to the target position; the oral film product can be moved multiple times and is more easily fitted to the target position. Basically, one oral film product can be used to fit to the target position, and the use cost can be significantly reduced.
[0060] The present application has at least the following beneficial effects:
[0061] By providing the sheet layer / sheet material, the tensile strength of the film product / oral film product can be improved, and the problem that the film product / oral film product is prone to wrinkling and deformation can be improved by using the sheet layer / sheet material that can maintain its shape for a long time, and the degree of deformation of the film product / oral film product before reaching the target position can be reduced; at the same time, the film product / oral film product will not disintegrate quickly after being placed at the target position, and the effect of withdrawing the film product / oral film product from the target position during use can be achieved; it can also effectively improve the situation that the film product / oral film product comes into contact with liquid and quickly deforms, adheres, breaks or disintegrates, resulting in difficulty in fitting to the target position. The film product / oral film product can be moved multiple times and is more easily fitted to the target position. Basically, one film product / oral film product can be used to fit to the target position, and the use cost can be significantly reduced. BRIEF DESCRIPTION OF THE DRAWINGS
[0062] Figure 1 It is a schematic structural diagram of a film product according to an embodiment of the present application. Among them, the upper figure is a schematic plan view of the film product, and the lower figure is a schematic cross-sectional view taken along line A-A in the upper figure.
[0063] Figure 2 It is a schematic structural diagram of a film product according to an embodiment of the present application. Among them, the upper figure is a schematic plan view of the film product, and the lower figure is a schematic cross-sectional view taken along line B-B in the upper figure.
[0064] Figure 3It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0065] Figure 4 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0066] Figure 5 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0067] Figure 6 It is a schematic plan structure diagram of a film agent product according to an embodiment of the present application.
[0068] Figure 7 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0069] Figure 8 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0070] Figure 9 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0071] Figure 10 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0072] Figure 11 It is a schematic plan structure diagram of a film agent product according to an embodiment of the present application.
[0073] Figure 12 It is a schematic plan structure diagram of a film agent product according to an embodiment of the present application.
[0074] Figure 13 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0075] Figure 14 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0076] Figure 15 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0077] Figure 16 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0078] Figure 17 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0079] Figure 18 It is a schematic cross-sectional structure diagram of a film agent product according to an embodiment of the present application.
[0080] Figure 19It is a schematic cross-sectional structure diagram of a film product according to an embodiment of the present application.
[0081] Figure 20 It is a schematic cross-sectional structure diagram of a film product according to an embodiment of the present application.
[0082] Figure 21 It is a schematic plan structure diagram of a film product according to an embodiment of the present application.
[0083] Figure 22 It is a schematic cross-sectional structure diagram of a film product according to an embodiment of the present application.
[0084] Figure 23 It is a schematic plan structure diagram of a film product according to an embodiment of the present application.
[0085] Figure 24 It is a photo of the nicotine functional film layer in Example 1.
[0086] Figure 25 It is a photo of the film product for the n1 port in Example 1.
[0087] Figure 26 It is a photo of the film product for the n2 port in Example 1.
[0088] Figure 27 It is the nicotine relative dissolution rate-time curve in Example 1.
[0089] Figure 28 It is the nicotine relative dissolution rate-time curve in Example 1.
[0090] Figure 29 It is a photo of the propolis film in Example 2.
[0091] Figure 30 It is a photo of the propolis film product encapsulated with non-woven fabric in Example 2.
[0092] Figure 31 It is a schematic diagram of the action position of the propolis film in Example 2.
[0093] Figure 32 It is a photo of the soluble dental patch in Example 3.
[0094] Figure 33 It is a photo of the soluble dental patch product encapsulated with non-woven fabric in Example 3.
[0095] Figure 34 It is a photo of the nicotine film product encapsulated with non-woven fabric in Example 5.
[0096] Figure 35 It is a photo of the nicotine film product encapsulated with non-woven fabric in Example 5.
[0097] Figure 36 It is a photo of the nicotine film product encapsulated with non-woven fabric in Example 5.
[0098] Figure 37 It is a photo of the nicotine film product encapsulated with non-woven fabric in Example 5.
[0099] Figure 38 It is a photo of the nicotine film product encapsulated with non-woven fabric in Example 5.
[0100] Figure 39 It is a photo of the swelling film in Example 6.
[0101] Figure 40 It is a photo of the swelling film product after encapsulation and printed with graphic information in Example 6.
[0102] Figure 41 It is a photo of the swelling film product after encapsulation and printed with graphic information in Example 6.
[0103] Figure 42 It is a photo of the swelling film product after encapsulation and printed with graphic information in Example 6.
[0104] Figure 43 It is a photo of the local shrinkage of the swelling film after contacting water in Example 6.
[0105] Figure 44 It is a photo of the nasal patch product in Example 9.
[0106] Figure 45 It is a schematic structural diagram of a film product group according to an embodiment of the present application.
[0107] Reference numerals:
[0108] 11: The first layer 110: The third sub-layer 111: The first sub-layer 112: The first detachment part 113: The first detachable area 114: The first non-detachable area 115: The first weak connection structure 12: The second layer 121: The second sub-layer 122: The second detachment part 123: The second detachable area 124: The second non-detachable area 125: The second weak connection structure 13: The third layer 14: The first opening 15: The porous layer 16: The through hole 100: The first accommodation space 20: The functional film layer 21: The first sub-functional film layer 22: The second sub-functional film layer 200: The second accommodation space 30: The waterproof layer 40: The water-swellable substance 50: The holding part Detailed Description of the Embodiments
[0109] The embodiments of the present invention will be described in detail below, and the examples of the embodiments are shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to explain the present invention, and should not be construed as limiting the present invention.
[0110] This application is completed based on the following discoveries and understandings of the inventors:
[0111] The film agent product can only exert its efficacy after dissolving or disintegrating at the target position. In this case, there is a technical prejudice that requires the film agent product to dissolve as quickly as possible. The inventors of this application found that when users use the film agent product, they usually directly hold the film agent product and place it or attach it to the target position (such as oral mucosa, teeth, gums, tongue, sublingual area, nasal mucosa, etc.). During this process, the film agent product may encounter liquids in the environment and dissolve, shrink, or deform prematurely. The user can only replace the new film agent product or move the film agent product with sticky hands. That is to say, in order to smoothly attach the film agent product to the target position, the film agent product does not dissolve as quickly as possible. In addition, the inventors of this application also found that the existing film agent products do not consider the need to withdraw midway. Therefore, the current film agent products can no longer meet the usage requirements of multiple scenarios and need to be further improved.
[0112] After long-term research, the inventors of this application proposed to add lamellae physically to improve the tensile strength of the film agent product, so as to enhance the ability of the film agent product to maintain its shape, and to improve the problems of shrinkage, deformation, difficulty in attaching to the target position, and difficulty in withdrawing midway during the use of the film agent product.
[0113] In view of this, in the first aspect of this application, a film agent product is provided. According to the embodiments of this application, the film agent product includes a functional film layer and a lamella. The functional film layer contains active ingredients, and the active ingredients are adapted to be released from the functional film layer and act on the target position. In some embodiments, the lamella includes a first lamella, and the first lamella is disposed on at least a part of the surface of the functional film layer. In other embodiments, the first lamella is embedded in the functional film layer.
[0114] In this film agent product, by setting the lamella, it can play a supporting role for the functional film layer, thereby improving the tensile strength of the film agent product, enhancing the ability of the film agent product to maintain its shape, and further making it less likely to have problems such as deformation, shrinkage, fragmentation, and adhesion. It can be flexibly moved to adjust the position, so as to be more accurately attached to the target position and is easy to withdraw during use.
[0115] In this article, the tensile strength, also known as the tensile strength or breaking strength, refers to the ability of a material to withstand the maximum stress without breaking when subjected to a tensile force.
[0116] Furthermore, the lamella disposed on the surface of the functional film layer can play a certain isolation role, thereby improving the adhesion problem between multiple film agent products and reducing the packaging cost. During use, the user can hold the position of the film agent product where the lamella is provided, so that the functional film layer is not easily in direct contact with the liquid on the user's hand and does not prematurely dissolve, deform, shrink, break, adhere, etc. This is beneficial to the accurate placement or attachment of the film agent product and can improve the usability of the film agent product.
[0117] In addition, after the first lamella disposed on the surface of the functional film layer contacts liquids such as saliva and body fluids, it can delay the time for the liquid to reach the functional film layer, reducing the possibility of the functional film layer dissolving before reaching the target position and resulting in the loss of active ingredients. After reaching the target position, the risk of causing discomfort to the user due to the rapid disintegration and release of a large amount of active ingredients and bringing too strong a stimulus is also reduced.
[0118] It can be understood that the functional film layer refers to a film-like preparation made by processing an active ingredient (such as a raw drug) and a suitable film-forming material. During use, the active ingredient in the functional film layer can be released from the functional film layer and act on the target position to play a role. The film agent product in this article refers to a product containing a functional film layer and a lamella, and the active ingredient in the functional film layer is suitable for being released from the functional film layer and acting on the target position.
[0119] Specifically, a part of the surface of the functional film layer can be exposed (i.e., not covered by the lamella) so that the active ingredient is released and acts on the target position. The lamella can also have water permeability. Specifically, the lamella itself can have water permeability, or the lamella does not have water permeability, but there are water-permeable channels provided on the lamella. Thus, liquids such as body fluids and saliva can infiltrate the functional film layer through the lamella or the water-permeable channels, so that the active ingredient in the functional film layer can dissolve, release, and act on the target position.
[0120] Specifically, in some embodiments, the first lamella can only cover a part of the surface of the functional film layer. At this time, the first lamella can be located at the edge of the functional film layer or in the middle of the functional film layer. With such a setting, during use, the position on the surface of the functional film layer where the first lamella is provided can be used for holding, and the first lamella can delay the liquid from reaching the functional film layer, thereby reducing the risk of wrinkles, deformation, and adhesion during the attachment process of the film agent product. And a part of the functional film layer is not covered by the first lamella, which can ensure the rapid dissolution and release of the active ingredient.
[0121] In other embodiments, the first lamella can also cover the entire surface of the functional film layer. In a specific example, refer to Figure 1, The following figure is a schematic cross-sectional view of the A-A section in the above figure. It can be seen that the first layer 11 covers one side surface of the functional film layer 20. Thus, the user can hold the side of the film product provided with the first layer 11, conveniently move the film product, and improve the problem that the film product is easy to stick to the hand. The surface of the functional film layer 20 not covered by the first layer 11 still maintains good adhesiveness and can be more easily attached to the target position.
[0122] According to an embodiment of the present application, referring to Figure 2 , The following figure is a schematic cross-sectional view of the B-B section in the above figure. It is not difficult to find that the layer can further include a second layer 12, and the first layer 11 and the second layer 12 are disposed on two opposite surfaces of the functional film layer 20. Thus, the first layer 11 and the second layer 12 act together, and the film product has greater tensile strength, which can better improve the problems that the film product is easy to wrinkle and deform; and the first layer 11 and the second layer 12 are located on two opposite surfaces of the functional film layer 20, which can delay the time for the liquid to reach the functional film layer and isolate between the functional film layers 20 of adjacent two film products. Thereby, the risk of adhesion of the functional film layer 20 during attachment, transportation, and storage can be reduced, it is more convenient for the user to move the film product during use, and the risk of loss of active ingredients due to dissolution of the film product before reaching the target position can also be reduced, thereby improving the usability of the film product. When the first layer 11 and the second layer 12 are not provided, adjacent two functional film layers 20 need to be isolated by a packaging structure such as aluminum foil to prevent adhesion. Therefore, by providing the first layer 11 and the second layer 12, the packaging cost of the film product can also be reduced.
[0123] It can be understood that the relative sizes, specific setting methods, etc. of the first layer 11, the functional film layer 20, and the second layer 12 can be flexibly adjusted according to actual use needs.
[0124] In some embodiments, the edges of at least two of the first layer 11, the functional film layer 20, and the second layer 12 are aligned. Specifically, it can be that the edges of the first layer 11 and the functional film layer 20 are aligned, or the edges of the second layer 12 and the functional film layer 20 are aligned, or the first layer and the second layer are aligned, or the edges of the first layer 11, the functional film layer 20, and the second layer 12 are aligned (refer to Figure 2 ). Thus, the first layer 11 and the second layer 12 can effectively play the role of improving the performance of the film product, while having a low cost and being easy to implement.
[0125] In some embodiments, part of the edges of the first layer 11 and the second layer 12 are connected to jointly form a first bag-like structure with at least one side edge open. A first accommodation space 100 is provided in the first bag-like structure, and at least part of the functional film layer is disposed in the first accommodation space 100. Specifically, referring toFigure 3 , part of the functional film layer 20 can be accommodated in the first accommodation space 100, and another part of the functional film layer 20 can be located outside the first accommodation space 100. It is also possible that the entire functional film layer 20 is accommodated in the first accommodation space 100 (refer to Figure 4 ).
[0126] With the structure provided by this embodiment, when the film agent product comes into contact with liquids such as body fluids and saliva, the sheet layer can preferentially absorb and infiltrate the liquid or isolate the liquid, delaying the contact between the functional film layer 20 placed in the first accommodation space 100 and the liquid. While delaying the rapid and massive release of the active ingredient in the functional film layer 20, the film agent product can also be moved arbitrarily according to requirements to accurately move to the target position, so that the active ingredient contained in the functional film layer 20 can mainly act on the target position. Even if the functional film layer 20 in the first accommodation space 100 wrinkles, deforms, breaks, disintegrates, etc. due to contact with the liquid, the first bag-like structure can play a certain limiting role on this part of the functional film layer 20, making it difficult for the functional film layer 20 to come into contact and adhere to non-target positions outside, reducing the risk of rapid dispersion of a large amount of dissolved or disintegrated functional film layer 20 causing physiological discomfort to users, and enabling the film agent product to withdraw from the target position at any time during use, improving the usability of the film agent product.
[0127] In some embodiments, the edges of the first sheet layer 11 and the second sheet layer 12 are connected to jointly form a second bag-like structure without an opening at the edge. A second accommodation space 200 is provided inside the second bag-like structure, and the functional film layer 20 is accommodated in the second accommodation space 200 (refer to Figure 5 ).
[0128] With the structure provided by this embodiment, when the film agent product comes into contact with liquids such as body fluids and saliva, the sheet layer can preferentially absorb and infiltrate the liquid or isolate the liquid, delaying the contact between the functional film layer 20 placed in the second accommodation space 200 and the liquid. While delaying the rapid and massive release of the active ingredient in the functional film layer 20, the film agent product can also be moved arbitrarily according to requirements to accurately move to the target position, so that the active ingredient contained in the functional film layer 20 can mainly act on the target position. Even if the functional film layer 20 in the second accommodation space 200 wrinkles, deforms, breaks, disintegrates, etc. due to contact with the liquid, the second bag-like structure can play a certain limiting role on the functional film layer 20, making it difficult for the functional film layer 20 to come into contact and adhere to non-target positions outside, reducing the risk of rapid dispersion of a large amount of dissolved or disintegrated functional film layer 20 causing physiological discomfort to users, and enabling the film agent product to withdraw from the target position at any time during use, improving the usability of the film agent product.
[0129] According to an embodiment of the present application, at least one of the first layer 11 and the second layer 12 has a first opening 14 according to the needs of different use positions, and a part of the functional film layer 20 is exposed through the first opening 14. Thus, the functional film layer 20 at the position corresponding to the first opening 14 is not covered by the layer, and the bonding performance with the target position is better. At the same time, the exposure of the functional film layer 20 at the position corresponding to the first opening 14 can appropriately increase the release rate of the active ingredient in the functional film layer 20 to meet different use requirements.
[0130] It can be understood that the first opening 14 can be provided only on the first layer 11 (refer to Figure 6 ), only on the second layer 12, or provided on both the first layer 11 and the second layer 12 at the same time.
[0131] In addition, there are no particular restrictions on the specific size, contour shape, and number of the first openings 14. For example, the contour shape can be rectangular, square, circular, diamond-shaped, triangular, polygonal, or irregular, and the number can be 1, 2, 3, 4, 5, etc., which can be flexibly adjusted according to actual use requirements.
[0132] According to an embodiment of the present application, according to the demand for the release rate of the active ingredient, the first layer 11 and the second layer 12 are each independently a single-layer structure or a multi-layer structure. Specifically, both the first layer 11 and the second layer 12 can be single-layer structures (refer to Figure 5 ).
[0133] In some embodiments, at least one of the first layer 11 and the second layer 12 includes a multi-layer structure. In some embodiments, the first layer 11 includes a plurality of first sub-layers stacked. In some embodiments, the second layer 12 includes a plurality of second sub-layers stacked.
[0134] Specifically, the first layer 11 can be a single-layer structure and the second layer 12 can be a multi-layer structure (refer to Figure 7 ). It is also possible that the first layer 11 is a multi-layer structure and the second layer 12 is a single-layer structure (refer to Figure 8 ). It is also possible that both the first layer 11 and the second layer 12 are multi-layer structures (refer to Figure 9 ).
[0135] Specifically, by setting the number of layers of the first sheet layer 11 and the second sheet layer 12, the release rate of the active ingredient can be adjusted. It can be understood that the more the number of layers of the first sheet layer 11 and / or the second sheet layer 12, the greater the resistance when the active ingredient is released from the functional film layer 20 to the outside, and the slower the release rate of the active ingredient. On the contrary, the fewer the number of layers of the first sheet layer 11 and / or the second sheet layer 12, the smaller the resistance when the active ingredient is released from the functional film layer 20 to the outside, and the faster the release rate of the active ingredient. For the multi-layer first sheet layer 11 and / or second sheet layer 12, when designing the film agent product, the sustained release and controlled release of the active ingredient can be achieved by adjusting the specific number of layers of the sheet layer.
[0136] According to the embodiments of the present application, the adjacent first sub-sheet layers 111 are detachably connected; and / or the adjacent second sub-sheet layers 121 are detachably connected. Specifically, through the detachable connection, the user can adjust the number of layers of the first sub-sheet layer 111 and / or the second sub-sheet layer 121 according to their own experience during actual use, and thus can better meet the usage requirements of different users.
[0137] It can be understood that there is no particular limitation on the specific manner of the detachable connection, as long as the detachable function can be achieved.
[0138] In some embodiments, referring to Figure 10 , the first sub-sheet layer 111 is provided with a first detachment portion 112. Thus, the user can conveniently tear off the first sub-sheet layer 111 by holding the first detachment portion 112.
[0139] In the text, the "first detachment portion" refers to a structure suitable for the user to hold, clamp, and by applying an external force to the first detachment portion 112, the first sub-sheet layer 111 connected to the first detachment portion 112 can be torn off. Similarly, the second detachment portion, the third detachment portion, the fourth detachment portion, the fifth detachment portion, and the sixth detachment portion mentioned later are the same as the first detachment portion, and will not be elaborated one by one later.
[0140] In some embodiments, the partial edges of two adjacent first sub-sheet layers 111 are not sealed, that is, some edges are exposed. Thus, the user can clearly identify the number of layers of the first sub-sheet layer 111 through the unsealed position, and can use the unsealed position to tear off the first sub-sheet layer 111.
[0141] In some embodiments, referring to Figure 10 , the second sub-sheet layer 121 is provided with a second detachment portion 122. Thus, the user can conveniently tear off the second sub-sheet layer 121 by holding the second detachment portion 122.
[0142] In some embodiments, partial edges of two adjacent second sub-sheet layers 121 are unsealed, that is, partial edges are open structures. Thus, users can clearly identify the number of layers of the second sub-sheet layer 121 through the unsealed positions and can hold the unsealed positions to tear off the second sub-sheet layer 121.
[0143] In some embodiments, referring to Figure 11 , the first sheet layer 11 includes a first detachable area 113 and a first non-detachable area 114, and the first detachable area 113 and the first non-detachable area 114 are connected by a first weak connection structure 115. Thus, users can tear off the first detachable area 113 along the first weak connection structure.
[0144] In this text, the first detachable area 113 refers to an area on the first sheet layer 11 that is suitable for being detached through certain operations, and the first non-detachable area 114 refers to an area on the first sheet layer 11 that is fixedly connected to other parts of the film product and is not suitable for being detached. The meanings of the second detachable area 123, the second non-detachable area 124, the fifth detachable area, the fifth non-detachable area, the sixth detachable area, and the sixth non-detachable area mentioned below are the same, and will not be elaborated one by one hereinafter.
[0145] In some embodiments, referring to Figure 12 , the second sheet layer 121 includes a second detachable area 123 and a second non-detachable area 124, and the second detachable area 123 and the second non-detachable area 124 are connected by a second weak connection structure 125. Thus, users can tear off the second detachable area 123 along the second weak connection structure.
[0146] In the text, the first weak connection structure and the second weak connection structure refer to structures with relatively weak connection strength or stability, and the weak connection structures can be damaged by simple tearing during use. As an example, the first weak connection structure and the second weak connection structure can independently be indentations, grooves, multiple spaced holes distributed along a contour line, etc.
[0147] According to an embodiment of the present application, the film product further includes: a waterproof layer 30. The waterproof layer can reduce the possibility that the active ingredients released from the functional film layer 20 enter non-target positions and cause discomfort, and enable more active ingredients to be absorbed by the target positions.
[0148] According to an embodiment of the present application, the specific setting position of the waterproof layer can be selected according to actual needs. Specifically, during actual use, users can choose to set the waterproof layer at corresponding non-target positions so that the waterproof layer is isolated between the non-target positions and the functional film layer.
[0149] In this text, the target position refers to the position where the active ingredient is desired to act; the non-target position refers to the position outside the target position, that is, the position where the active ingredient is not desired to act. For example, taking a film product for treating oral ulcers as an example, the position where oral ulcers occur is the target position, and the position outside where oral ulcers occur is the non-target position.
[0150] In some embodiments, the film product includes a functional film layer 20 and a first sheet layer 11, and a waterproof layer 30 is disposed on the surface of the first sheet layer 11 away from the functional film layer 20 or on the surface of the functional film layer 20 not covered by the first sheet layer 11. Specifically, the waterproof layer 30 is disposed on the surface of the functional layer 20 away from the first sheet layer 11 (refer to Figure 13 ) or on the surface of the functional film layer 20 not covered by the first sheet layer 11.
[0151] In some embodiments, the film product includes a functional film layer 20, a first sheet layer 11, and a second sheet layer 12. The functional film layer 20 is sandwiched between the first sheet layer 11 and the second sheet layer 12, and the waterproof layer 30 is disposed on the surface of the first sheet layer 11 away from the functional film layer 20 (refer to Figure 14 ), on the surface of the second sheet layer 12 away from the functional film layer 20 (refer to Figure 15 ), or on the surface of the functional film layer 20 not covered by the first sheet layer 11 and the second sheet layer 12.
[0152] By providing the waterproof layer 30, the delivery of the active ingredient released from the functional film layer 20 to the non-target position can be reduced. For example, the active ingredient that needs to be absorbed through the oral mucosa in the functional film layer 20 entering the digestive tract with saliva can be reduced. The active ingredient released from the functional film layer 20 mainly acts on the target position.
[0153] According to an embodiment of the present application, the film product further includes: a water-swellable substance 40, and the water-swellable substance 40 is disposed at at least one of the following positions: the surface of the first sheet layer 11, the surface of the second sheet layer 12, the pores of the first sheet layer 11, and the pores of the second sheet layer 12. Specifically, the water-swellable substance 40 can be disposed on the surface of the first sheet layer 11 close to the functional film layer 20 and / or on the surface of the second sheet layer 12 close to the functional film layer 20 (refer to Figure 16 ). After the water-swellable substance 40 absorbs water and swells, the overall tensile strength of the film product can be improved, which is convenient for the user to move the film product and improves the usability of the film product.
[0154] According to an embodiment of the present application, the first sheet layer 11 and the second sheet layer 12 are the same. Thus, the release rate of the active ingredient on both surfaces of the film product is consistent, and a stable experience can be provided for the user.
[0155] According to an embodiment of the present application, in order to meet the requirements of different usage scenarios and enrich the user experience, the first sheet layer 11 and the second sheet layer 12 may have different properties, so as to achieve different usage experiences and usage effects. According to an embodiment of the present application, at least one of the water permeability, porosity, thickness, material, tensile strength, and number of layers of the first sheet layer 11 and the second sheet layer 12 is different. Thereby, different active ingredient release rates can be provided on both surfaces of the film product, enriching the user experience and meeting the personalized usage needs of more usage scenarios and more users.
[0156] According to an embodiment of the present application, there is no particular limitation on the materials of the first sheet layer 11 and the second sheet layer 12, as long as the usage requirements of the target position are met. For example, for a film product used in the oral cavity, the first sheet layer 11 and the second sheet layer 12 can adopt flexible materials so that the film product can fit the shape inside the oral cavity as much as possible to avoid causing discomfort to the user.
[0157] Specifically, according to the different setting methods of the first sheet layer 11 and the second sheet layer 12, the material selection is also different. If at least part of the functional film layer 20 is not wrapped by the first sheet layer 11 and the second sheet layer 12, there is no limitation on the water permeability of the first sheet layer 11 and the second sheet layer 12. The first sheet layer 11 and the second sheet layer 12 may have water permeability or may not have water permeability. If the first sheet layer 11 and the second sheet layer 12 wrap the functional film layer 20 completely, it is required that at least one of the first sheet layer 11 and the second sheet layer 12 has water permeability, or the first sheet layer 11 and the second sheet layer 12 do not have water permeability but are provided with water-permeable channels, such as through holes provided on a plastic sheet layer without water permeability. Thereby, it can be ensured that the active ingredients in the functional film layer 20 can be effectively released and act on the target position.
[0158] According to an embodiment of the present application, the water-permeable channel includes a through hole 16, or includes a through hole 16 and a porous layer 15 detachably covering the through hole 16. Figure 17 The situation where the porous layer 15 completely covers the through hole 16 is shown. During use, the user can choose whether to open the porous layer 15. When the porous layer 15 is opened, the active ingredients released by the functional film layer 20 can be more absorbed by the target position through the through hole 16, obtaining a stronger stimulation. When the porous layer 15 is not opened, the active ingredients released by the functional film layer 20 need to pass through the porous layer 15 and be released and act on the target position, and the release rate of the active ingredients is relatively slow.
[0159] According to an embodiment of the present application, the first sheet layer 11 and the second sheet layer 12 each independently include at least one of non-woven fabric, special paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh cloth, woven fabric, foamed resin film, reticular resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet provided with the water permeable channel, and rubber sheet provided with the water permeable channel. Thus, the sheet layer has good liquid permeability, which is beneficial for the functional film layer 20 to contact with the liquid and release the active ingredient to act on the target position.
[0160] In this text, the swellable sheet refers to a sheet having swellability, and the swellable mesh refers to a mesh having swellability. Both can absorb and retain liquid, that is, they can absorb liquid and lock the liquid in the swellable sheet and the swellable mesh. As an example, it may include edible film, edible gum mesh, such as carrageenan film, carrageenan mesh, etc.
[0161] According to an embodiment of the present application, in order to better meet the usage requirements, the functional film layer 20 may include a plurality of sub-functional film layers, and the plurality of sub-functional film layers are the same, or at least one of the types and concentrations of the active ingredients contained in the plurality of sub-functional film layers is different. Thus, in the case where the thickness of a single functional film layer is limited, by setting a plurality of sub-functional film layers, a greater thickness and a greater dose of the active ingredient can be achieved. When the plurality of sub-functional film layers are different, the film agent product can have multiple effects or different usage experiences. Specifically, if the active ingredients in the plurality of sub-functional film layers are different, different usage effects can be achieved, and if the concentrations of the active ingredients in the plurality of sub-functional film layers are different, different release rates of the active ingredients can be achieved at different stages of the usage process, enriching the user experience and usage effect.
[0162] According to an embodiment of the present application, there is no particular limitation on the specific setting method of the plurality of sub-functional film layers. They can be stacked or arranged in a flat manner on one surface. In some embodiments, the sub-functional film layer includes at least one of the first sub-functional film layer 21 and the second sub-functional film layer 22, wherein a plurality of first sub-film layers 21 are stacked in sequence, and a plurality of second sub-functional film layers 22 are arranged in a flat manner on the first surface. Specifically, the functional film layer 20 may only include a plurality of first sub-functional film layers 21 (refer to Figure 18 ); the functional film layer may only include a plurality of second sub-functional film layers 22 (refer to Figure 19 ); the functional film layer may also include a plurality of first sub-functional film layers 21 and at least one second sub-functional film layer 22 at the same time (refer to Figure 20 ).
[0163] It can be understood that during the actual use of the film agent product, the release of the active ingredient proceeds in the order from the outside to the inside and from the periphery to the middle. Based on this, by setting different components, different concentrations, and different setting methods of the sub-functional film layers, a more abundant usage experience and usage effect can be achieved.
[0164] It should be noted that the description method "tiled and arranged in a plane" adopted in this text can be tiled and arranged in a plane or in a curved surface.
[0165] According to an embodiment of the present application, adjacent first sub-functional film layers 21 are detachably connected to each other; and / or the second sub-functional film layer 22 and the sheet are detachably connected. Thus, the user can flexibly adjust the types and quantities of the sub-functional film layers according to personal actual needs, better meeting the personalized needs of the user.
[0166] According to an embodiment of the present application, the first sub-functional film layer 21 is provided with a third disassembly part. Thus, the user can conveniently tear off the first sub-functional film layer 21 through the third disassembly part, better meeting the personalized needs of the user.
[0167] According to an embodiment of the present application, the partial edges of two connected first sub-functional film layers 21 are not sealed. Thus, the user can clearly identify the number of layers of the first sub-functional film layer 21 through the unsealed position, and can hold the unsealed position to tear off the first sub-functional film layer 21.
[0168] According to an embodiment of the present application, the second sub-functional film layer 22 is provided with a fourth disassembly part. Thus, the user can conveniently tear off the second sub-functional film layer 22 through the fourth disassembly part, better meeting the personalized needs of the user.
[0169] According to an embodiment of the present application, the partial edges of the second sub-functional film layer 22 and the sheet are not sealed. Thus, the user can clearly identify the number of layers of the second sub-functional film layer 22 through the unsealed position, and can hold the unsealed position to tear off the second sub-functional film layer 22.
[0170] According to an embodiment of the present application, referring to Figure 21 , the first sheet 11 includes a plurality of third sub-sheets 110. The plurality of third sub-sheets 110 are substantially parallel to the first surface. The orthographic projection of each third sub-sheet 110 on the first surface and the orthographic projection of at least one second sub-functional film layer 22 on the first surface have an overlapping area; at least one of the water permeability, material, porosity, tensile strength, thickness and number of layers of the plurality of third sub-sheets 110 is different. Thus, different second sub-functional film layers 22 can have different active ingredient release rates, better meeting the needs of the user and enriching the user experience.
[0171] In the text, the third sub-sheet layer 110 being substantially parallel to the first surface means that the third sub-sheet layer 110 is parallel to the first surface, or the distance between any position on the third sub-sheet layer 110 and the first surface fluctuates within a relatively small reasonable range, such as reasonable measurement errors, etc. Specifically, for example, the percentage difference in the distances between any two points on the third sub-sheet layer 110 and the first surface (the absolute value of the difference between the two values / the average of the two values × 100%) is not greater than 5%, etc.
[0172] According to an embodiment of the present application, referring to Figure 22 , the sheet further includes at least one third sheet layer 13, and the third sheet layer 13 is sandwiched between two adjacent first sub-functional film layers 21. Thus, the third sheet layer 13 can play an isolation role between the adjacent first sub-functional film layers 21. At the same time, the presence of the third sheet layer will also increase a certain resistance to the release of the active ingredient, and can achieve the effect of controlling different release rates of the active ingredient in different first sub-functional film layers.
[0173] According to an embodiment of the present application, at least one of the water permeability, material, porosity, thickness, tensile strength, and number of layers of the plurality of third sheet layers 13 is different. Thus, due to the differences in the above parameters of the third sheet layer, the resistance of the active ingredient to penetrate the third sheet layer is different, and different release rates of the active ingredient can be achieved, enriching the user experience.
[0174] According to an embodiment of the present application, referring to Figure 23 , the film product may further include a holding part 50. Thus, the user can move the film product by holding the holding part, so as to be able to accurately place it at the target position during use, and can take out the film product in advance by holding the holding part during use, enabling the film product to adapt to diverse usage requirements and greatly improving the usability of the film product.
[0175] According to an embodiment of the present application, the specific form of the holding part may not be particularly limited as long as it is convenient to hold during the process of fitting the film product. In some embodiments, the holding part includes at least one of a traction line and a handle. Specifically, a traction line can be sewn or pasted on the sheet to form a structure similar to a tea bag; or the handle can be formed by the sheet or the sheet and the functional film layer together. Thus, the structure is simple and the use is convenient.
[0176] According to an embodiment of the present application, referring to Figure 23 , the holding part 50 is located at the edge of the film product. Specifically, the holding part can be located at one end of the film product, opposite ends, or multiple spaced holding parts can be provided on one side edge of the film product, etc. Thus, the film product can be moved more flexibly through the holding part, and the mobility of the film product can be improved.
[0177] According to an embodiment of the present application, the holding part includes a part made of a sheet layer, or the holding part includes a part of the sheet layer and a part of the functional film layer. Specifically, by providing the sheet layer, the tensile strength of the film product is enhanced and the mechanical strength is higher. A part of the film product, that is, the sheet layer and the functional film layer together form the holding part, can be directly held. In some other embodiments, the holding part can be formed by making the sheet layer exceed a part of the functional film layer, and the exceeding part constitutes the holding part.
[0178] According to an embodiment of the present application, graphic and text information is printed on the film product. Thereby, it is convenient to use. Specifically, the graphic and text information can include any information such as pictures, textures, and words. As an example, the graphic and text information can include the type of active ingredient, the concentration of active ingredient, taste, expiration date, instructions for use, brand logo, decorative pattern, etc. of the functional film layer. Users can identify the uses, dosages, etc. of the film product according to the graphic and text information such as the type of active ingredient, the concentration of active ingredient, and taste; the brand logo is suitable for merchants to establish brand awareness; and the decorative pattern can increase the aesthetic feeling of the appearance of the film product.
[0179] Specifically, the graphic and text information can be formed on the sheet layer or can be formed on the sheet layer and the functional film layer at the same time. In some embodiments, the graphic and text information can be printed or can be the traces formed by ultrasonic embossing treatment. The traces can include at least one of indentations, protrusions, and hollowings, and the traces can be used to represent the graphic and text information.
[0180] According to an embodiment of the present application, the film product includes at least one of buccal film products, sublingual film products, supra-lingual film products, oral mucosa film products, gingival film products, dental patch products, and nasal cavity film products.
[0181] In this article, a buccal film product refers to a film product that is pasted on the oral mucosa at the posterior position of both corners of the mouth and exerts local or systemic effects after being absorbed through the mucosa. A sublingual film product refers to a film product designed to be quickly absorbed through the sublingual mucosa. A supra-lingual film product refers to a film product designed to be quickly absorbed through the supra-lingual mucosa. An oral mucosa film product refers to a film product that can be placed on the oral mucosa and absorbs active ingredients through the oral mucosa to exert local or systemic therapeutic effects. A gingival film product refers to a film product that can be applied to the gums. A dental patch refers to a film product that can be applied to the tooth body. A nasal cavity film refers to a film product that can be placed in the nasal cavity and absorbs active ingredients through the nasal mucosa to exert local or systemic therapeutic effects.
[0182] According to an embodiment of the present application, the outer contour shape of the film agent product includes at least one of a square, a rectangle, a circle, a triangle, a polygon, and an irregular shape. It can be understood that for different use parts, the shape of the film agent product can be designed according to ergonomics and convenience. For example, for mucosal positions such as buccal film products and sublingual film products where the area is relatively wide, circular or square film agent products can be used; for the gingiva, a long and narrow film agent product can be used; for the alveolar bone, a wider film agent product can be used, and so on.
[0183] According to an embodiment of the present application, the maximum size of the outer contour of the film agent product is 0.1 - 8 cm, specifically it can be 0.8 cm - 3 cm, and more specifically it can be 0.1 cm, 0.5 cm, 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm, 7 cm, 7.5 cm, 8 cm, etc.; the minimum size is 0.1 - 1.5 cm, specifically it can be 0.6 cm - 1.2 cm, and more specifically it can be 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 0.6 cm, 0.7 cm, 0.8 cm, 0.9 cm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.4 cm, 1.5 cm, etc. It should be noted that the maximum size refers to the maximum distance between any two points on the outer contour line of the film agent product, and the minimum size refers to the minimum distance between any two points on the outer contour line of the film agent product. Within the above size range, it can meet the usage requirements of multiple parts such as the oral cavity and nasal cavity.
[0184] According to an embodiment of the present application, the functional film layer includes at least one of a completely dissolved film layer, a partially dissolved film layer, or a swollen film layer. Specifically, the film agent product provided by the present application can adopt the above different types of functional film layers, with a wider range of functions, and at the same time can meet the usage requirements of different usage scenarios, and has higher usage convenience.
[0185] In this article, the completely dissolved film layer means that the entire functional film layer is completely dissolved in the usage environment of the film agent product, no longer existing in the original form of the functional film layer, but becoming a molecular or ionic state uniformly dispersed in the solvent. The partially dissolved film layer means that only a part of the functional film layer dissolves, and another part remains relatively intact; this may be due to different chemical properties of different regions of the functional film layer or different degrees of interaction with the solvent. The swollen film layer means that when the functional film layer comes into contact with the liquid in the usage environment of the film agent product, it absorbs these liquids and swells in volume, but does not really dissolve. The functional film layer still maintains a certain integrity, only the size becomes larger, and its basic structure and performance may change.
[0186] According to an embodiment of the present application, the functional film layer contains active ingredients, and the active ingredients include at least one of pharmaceutical ingredients, nutraceutical ingredients, food ingredients, daily chemical ingredients, and alkaloids. Through the structure provided by this embodiment, functions such as treatment, nutraceutical care, consumption, beauty and skin care, and fatigue relief can be effectively exerted.
[0187] In this text, the pharmaceutical ingredient refers to a drug with a certain therapeutic effect. According to an embodiment of the present application, the pharmaceutical ingredients include at least one of oral ulcer drugs, psychiatric drugs, painkillers, anti-inflammatory drugs, cannabinoids and their derivatives, nasal medications, respiratory medications, and sildenafil.
[0188] In this text, the nutraceutical ingredient refers to an ingredient that can supplement nutrition for the human body and is beneficial to maintaining human health. According to an embodiment of the present application, the nutraceutical ingredients include at least one of American ginseng extract, Schisandra chinensis extract, Ganoderma lucidum extract, arginine, propolis, melatonin, glutathione, and taurine.
[0189] In this text, the food ingredient refers to a substance that can be ingested orally and can maintain life, development, that is, provide energy and form or replace tissues. According to an embodiment of the present application, the food ingredients include at least one of tea extract, coffee extract, and vitamins.
[0190] In this text, the daily chemical ingredient refers to an ingredient used for daily use such as beauty and skin care, tooth whitening, etc. According to an embodiment of the present application, the daily chemical ingredients include at least one of papain, catalase, tooth whitening ingredients, oral repair ingredients, and anti-aging ingredients.
[0191] In this text, alkaloids are a class of nitrogen-containing organic compounds that exist in many plants, animals, and microorganisms in nature. They are usually alkaline and can react with acids to form salts. According to an embodiment of the present application, the alkaloids include at least one of nicotine and its derivatives, caffeine and its analogs, arecoline and its analogs, and hexamethyl nicotine.
[0192] It should be noted that when multiple active ingredients are used simultaneously in a film product, it is necessary to ensure that there is no mutually exclusive relationship among the multiple active ingredients. The absence of a mutually exclusive relationship can mean that there are no side reactions among the multiple active ingredients that may have an adverse effect on the usage effect, or that the multiple active ingredients do not have opposite effects, or that the combined action of the multiple active ingredients will not cause adverse effects on the human body, etc. Specifically, when multiple active ingredients are used simultaneously in a film product, it is necessary to comply with the treatment specifications of the active ingredients, such as the regulations of the pharmacopoeia, so that the product meets the requirements of industry compliance or mandatory standards.
[0193] Thus, the film product has a wide range of uses and can meet the needs of diverse usage scenarios.
[0194] It can be understood that the film agent products are independent individuals, and multiple film agent products can be packaged into a single packaging box. In some embodiments, multiple independent film agent products can be directly packaged into a single packaging box. In other embodiments, multiple film agent products can be connected to form a group of film agent products, and then one or more groups of film agent products can be packaged into a single packaging box.
[0195] In some embodiments, multiple film agent products can be connected by a weak connection structure to form a group of film agent products. In other embodiments, multiple film agent products can be connected to a support body by a weak connection structure to form a group of film agent products. In still other embodiments, multiple film agent products are connected to each other and to the support body by a weak connection structure to form a group of film agent products. This can facilitate the packaging, storage, and counting of the film agent products. As an example, Figure 45 shows a case of a group of film agent products in which multiple film agent products are connected by a weak connection structure in one embodiment.
[0196] Specifically, the group of film agent products can be a string of connected film agent products, or multiple film agent products arranged in a matrix, or multiple film agent products forming other irregular shapes, such as dendritic (with the branches as the support body and the leaves as the film agent products), etc. In addition, the group of film agent products can be placed flat in the packaging box, or folded and placed in the packaging box, or wound and placed in the packaging box.
[0197] In this document, the support body refers to a structure that connects multiple film agent products together, enables multiple film agent products to be connected and forms a group of film agent products. As an example, the film agent products can be formed by cutting and encapsulating a large sheet base material and a functional film layer base material. At this time, the shapes of the film agent products and the support body can be cut, and the film agent products and the support body are connected by a weak connection structure. The weak connection structure refers to a structure with relatively weak connection strength or stability, and the weak connection structure can be destroyed by simple tearing during use. As an example, the weak connection structure can be an indentation, a groove, multiple spaced holes distributed along the contour line, etc. The weak connection structure can be formed by ultrasonic embossing treatment or other means.
[0198] In the second aspect of the present application, an oral film product is provided. According to the embodiments of the present application, the oral film product includes an oral film and a sheet. The oral film contains an active ingredient, and the active ingredient is adapted to be released from the oral film and act on the target position. In some embodiments, the sheet includes a first sheet, and the first sheet can be disposed on at least a part of the surface of the oral film. In other embodiments, the first sheet can also be embedded inside the oral film.
[0199] Specifically, by setting the sheet material, the tensile strength of the oral film product can be improved, and the problem of easy wrinkling and deformation of the oral film product can be improved by using a sheet layer that can maintain its shape for a long time, reducing the degree of deformation of the oral film product when it does not reach the target position. At the same time, the oral film product will not disintegrate quickly after being placed at the target position, and the effect of withdrawing the oral film product from the target position during use can be achieved. It can also effectively improve the situation where the oral film product quickly deforms, adheres, breaks or disintegrates when contacting a liquid, making it difficult to fit to the target position. The oral film product can be moved multiple times and is easier to fit to the target position. Basically, one oral film product can be used to fit to the target position, and the use cost can be significantly reduced.
[0200] Furthermore, the sheet material provided on the surface of the oral film can play a certain isolation role, thus improving the adhesion problem between multiple oral film products and reducing the packaging cost. During use, the user can hold the position of the oral film product where the sheet material is provided, so that the oral film is not easily directly contacted with the liquid on the user's hand and does not dissolve, deform, shrink, break, adhere, etc. in advance, which is beneficial to the accurate placement or attachment of the oral film product and can improve the usability of the oral film product.
[0201] In addition, after the first sheet layer provided on the surface of the oral film contacts liquids such as saliva and body fluids, the time for the liquid to reach the oral film can be delayed, reducing the possibility of loss of active ingredients due to the dissolution of the oral film before reaching the target position, and also reducing the risk of causing discomfort to the user due to the rapid disintegration and release of a large amount of active ingredients after reaching the target position.
[0202] It can be understood that the oral film is a film agent whose action site is in the oral cavity, including "oral soluble film, buccal film, sublingual film, supra-lingual film, oral mucosa film, gingival film, dental patch", etc. Specifically, the oral film can be a film preparation for oral use made by processing an active ingredient (such as a raw drug) and a suitable film-forming material. During use, the active ingredient in the oral film can be released and act on the target position to play a role. Among them, the oral soluble film is a dosage form that uses a soluble film to absorb the active ingredient in the oral cavity (cheek or sublingual).
[0203] The oral film product in this article refers to a product containing an oral film and a sheet material, and the active ingredient in the oral film is suitable for being released from the oral film and acting on the target position. Specifically, a part of the surface of the oral film can be exposed (i.e., not covered by the sheet material) so that the active ingredient is released to act on the target position; or the sheet material can have water permeability. Specifically, the sheet material can have water permeability, or the sheet material does not have water permeability, but there are water-permeable channels provided on the sheet material. Thus, saliva can infiltrate the oral film through the sheet material, and then the oral film dissolves and releases the active ingredient to act on the target position.
[0204] Specifically, in some embodiments, the first sheet may only cover a partial surface of the oral film. At this time, the first sheet may be located at the edge of the oral film or in the middle of the oral film. With such a setting, during use, the position of the oral film surface where the first sheet is provided can be used for gripping, and the first sheet can delay the liquid from reaching the oral film, thereby reducing the risks of wrinkles, deformation, and adhesion during the attachment process of the oral film product. And the part of the oral film not covered by the first layer can ensure the rapid dissolution and release of the active ingredient.
[0205] In other embodiments, the first sheet may also cover the entire surface of the oral film. In a specific example, the first sheet covers one side surface of the oral film. Thus, the user can hold the side of the oral film product where the first sheet is provided, conveniently move the oral film product, and improve the problem that the oral film product is prone to sticking to the hand. And the surface of the oral film not covered by the first sheet still maintains good adhesiveness and can be more easily attached to the target position.
[0206] According to an embodiment of the present application, the sheet further includes a second sheet, and the first sheet and the second sheet are disposed on two opposite surfaces of the oral film. Thus, the first sheet and the second sheet act together, and the oral film product has greater tensile resistance and can better improve the problems that the oral film product is prone to wrinkles and deformation. And the first sheet and the second sheet are located on two opposite surfaces of the oral film, which can delay the time for the liquid to reach the oral film and isolate between the oral films of adjacent two oral film products, thereby reducing the risk of adhesion during the attachment, transportation, and storage of the oral film, making it more convenient for the user to move the oral film product during use. It can also reduce the risk of loss of active ingredient due to dissolution of the oral film product before reaching the target position, thereby improving the usability of the oral film product. When the first sheet and the second sheet are not provided, adjacent two oral films need to be isolated by a packaging structure such as aluminum foil to prevent adhesion. Therefore, by providing the first sheet and the second sheet, the packaging cost of the oral film product can also be reduced.
[0207] It can be understood that the relative sizes, specific setting methods, etc. of the first sheet, the oral film, and the second sheet can be flexibly adjusted according to actual use needs.
[0208] In some embodiments, the edges of at least two of the first sheet, the oral film, and the second sheet are aligned. Specifically, the edges of the first sheet and the oral film can be aligned; the edges of the second sheet and the oral film can also be aligned; or the edges of the first sheet, the oral film, and the second sheet can be aligned. Thus, the first sheet and the second sheet can effectively play the role of improving problems such as wrinkles, deformation, adhesion, and rapid dissolution of the oral film, and at the same time, the cost is low and it is easy to implement.
[0209] In some embodiments, the first sheet and the second sheet are connected at partial edges to jointly form a third bag-like structure with an opening at least on one side edge. A third accommodation space is provided inside the third bag-like structure, and at least part of the oral film is disposed in the third accommodation space. Specifically, part of the oral film can be accommodated in the third accommodation space, and another part of the oral film can be located outside the third accommodation space. Or the entire oral film can be accommodated in the third accommodation space.
[0210] With the structure provided by this embodiment, when the oral film product comes into contact with liquids such as body fluids and saliva, the sheet can preferentially absorb and infiltrate the liquid or isolate the liquid, delaying the contact and dissolution of the oral film placed in the third accommodation space with saliva. While delaying the rapid and massive release of the active ingredients in the oral film, the oral film product can also be moved around as needed to accurately move to the target position, enabling the active ingredients contained in the oral film to mainly act on the target position. Even if the oral film in the third accommodation space wrinkles, deforms, breaks, disintegrates, etc. due to contact with the liquid, the third bag-like structure can play a certain limiting role on this part of the oral film, making it difficult for the oral film to come into contact and adhere to non-target positions outside, reducing the risk of causing physiological discomfort to the user due to the rapid dispersion of a large amount of dissolved or disintegrated oral film, and enabling the oral film product to exit the target position at any time during use, improving the usability of the oral film product.
[0211] In some embodiments, the first sheet and the second sheet are connected at the edges to jointly form a fourth bag-like structure without an opening at the edge. A fourth accommodation space is provided inside the fourth bag-like structure, and the oral film is accommodated in the fourth accommodation space.
[0212] With the structure provided by this embodiment, when the oral film product comes into contact with liquids such as body fluids and saliva, the sheet can preferentially absorb and infiltrate the liquid or isolate the liquid, delaying the contact and dissolution of the oral film placed in the third accommodation space with saliva. While delaying the rapid and massive release of the active ingredients in the oral film, the oral film product can also be moved around as needed to accurately move to the target position, enabling the active ingredients contained in the oral film to mainly act on the target position. Even if the oral film in the third accommodation space wrinkles, deforms, breaks, disintegrates, etc. due to contact with the liquid, the third bag-like structure can play a certain limiting role on this part of the oral film, making it difficult for the oral film to come into contact and adhere to non-target positions outside, reducing the risk of causing physiological discomfort to the user due to the rapid dispersion of a large amount of dissolved or disintegrated oral film, and enabling the oral film product to exit the target position at any time during use, improving the usability of the oral film product.
[0213] According to an embodiment of the present application, at least one of the first sheet and the second sheet has a second opening according to the needs of different use positions, and a part of the oral film is exposed through the second opening. Thus, the oral film at the position corresponding to the second opening is not covered by the sheet layer, and the bonding performance with the target position is better. At the same time, the exposure of the oral film at the second opening position can appropriately increase the release rate of the active ingredient in the oral film to meet different use requirements.
[0214] It can be understood that the second opening can be provided only on the first sheet, only on the second sheet, or on both the first sheet and the second sheet at the same time.
[0215] In addition, there are no specific limitations on the specific size, contour shape, and number of the second openings. For example, the contour shape can be rectangular, square, circular, diamond-shaped, triangular, polygonal, or irregular, and the number can be 1, 2, 3, 4, 5, etc., which can be flexibly adjusted according to actual use requirements.
[0216] According to an embodiment of the present application, according to the requirement of the release rate of the active ingredient, the first sheet and the second sheet are each independently a single-layer structure or a multi-layer structure. Specifically, both the first sheet and the second sheet can be single-layer structures.
[0217] In some embodiments, at least one of the first sheet and the second sheet includes a multi-layer structure. In some embodiments, the first sheet includes a plurality of first sub-sheets stacked on top of each other. In some embodiments, the second sheet includes a plurality of second sub-sheets stacked on top of each other.
[0218] Specifically, the first sheet can be a single-layer structure and the second sheet can be a multi-layer structure. Or the first sheet can be a multi-layer structure and the second sheet can be a single-layer structure. It is also possible that both the first sheet and the second sheet are multi-layer structures.
[0219] Specifically, by setting the number of layers of the first sheet and the second sheet, the release rate of the active ingredient can be adjusted. It can be understood that the more layers the first sheet and / or the second sheet have, the greater the resistance when the active ingredient is released from the oral film to the outside, and the slower the release rate of the active ingredient. On the contrary, the fewer layers the first sheet and / or the second sheet have, the smaller the resistance when the active ingredient is released from the oral film to the outside, and the faster the release rate of the active ingredient. For the multi-layer first sheet and / or second sheet, when designing the oral film product, the sustained release and controlled release of the active ingredient can be achieved by adjusting the specific number of layers of the sheet.
[0220] According to an embodiment of the present application, the adjacent first sub-sheets are detachably connected; and / or the adjacent second sub-sheets are detachably connected. Specifically, through the detachable connection, the user can adjust the number of layers of the first sub-sheets and / or the second sub-sheets according to their own experience during actual use, so as to better meet the usage requirements of different users.
[0221] It can be understood that there is no particular limitation on the specific manner of the detachable connection, as long as the detachable function can be realized.
[0222] In some embodiments, the first sub-sheet is provided with a fifth detachment portion. Thus, the user can conveniently tear off the first sub-sheet by holding the fifth detachment portion.
[0223] In some embodiments, the partial edges of two adjacent first sub-sheets are not sealed, that is, the partial edges are of an open structure. Thus, the user can clearly identify the number of layers of the first sub-sheets through the unsealed positions, and can hold the unsealed positions to tear off the first sub-sheets.
[0224] In some embodiments, the second sub-sheet is provided with a sixth detachment portion. Thus, the user can conveniently tear off the second sub-sheet by holding the sixth detachment portion.
[0225] In some embodiments, the partial edges of two adjacent second sub-sheets are not sealed, that is, the partial edges are of an open structure. Thus, the user can clearly identify the number of layers of the second sub-sheets through the unsealed positions, and can hold the unsealed positions to tear off the second sub-sheets.
[0226] In some embodiments, the first sheet includes a fifth detachable region and a fifth non-detachable region, and the fifth detachable region and the fifth non-detachable region are connected by a fifth weak connection structure. Thus, the user can tear off the fifth detachable region along the fifth weak connection structure.
[0227] In some embodiments, the second sheet includes a sixth detachable region and a sixth non-detachable region, and the sixth detachable region and the sixth non-detachable region are connected by a sixth weak connection structure. Thus, the user can tear off the sixth detachable region along the sixth weak connection structure.
[0228] In the text, the fifth weak connection structure and the sixth weak connection structure refer to structures with relatively weak connection strength or stability, and the weak connection structures can be damaged by simple tearing during use. As an example, the fifth weak connection structure and the sixth weak connection structure can independently be indentations, grooves, a plurality of spaced holes distributed along a contour line, etc.
[0229] According to an embodiment of the present application, the oral film product further includes: a waterproof layer. The waterproof layer can reduce the entry of the active ingredients released by the oral film into non-target positions and cause discomfort, and enable more active ingredients to be absorbed by the target positions.
[0230] According to an embodiment of the present application, the specific setting position of the waterproof layer can be selected according to actual needs. Specifically, during actual use, the user can choose to set the waterproof layer at a corresponding non-target position so that the waterproof layer is isolated between the non-target position and the oral film.
[0231] In some embodiments, the oral film product includes an oral film and a first sheet, and the waterproof layer is disposed on the surface of the first sheet away from the oral film or on the surface of the oral film not covered by the first sheet.
[0232] In some embodiments, the oral film product includes an oral film, a first sheet, and a second sheet. The oral film is sandwiched between the first sheet and the second sheet, and the waterproof layer is disposed on the surface of the first sheet away from the oral film, on the surface of the second sheet away from the oral film, or on the surface of the oral film not covered by the first sheet and the second sheet.
[0233] Setting the waterproof layer can reduce the delivery of the active ingredient released from the oral film to the non-target position. For example, it can reduce the entry of drugs that need to be absorbed through the oral mucosa in the oral film into the digestive tract with saliva. The active ingredient released from the oral film mainly acts on the target position, enabling more of the active ingredient to be absorbed by the target position.
[0234] According to an embodiment of the present application, the oral film product further includes: a water-swellable substance, and the water-swellable substance is disposed at least one of the following positions: the surface of the first sheet, the surface of the second sheet, the pores of the first sheet, and the pores of the second sheet. Specifically, the water-swellable substance can be disposed on the surface of the first sheet close to the oral film and / or on the surface of the second sheet close to the oral film. After the water-swellable substance absorbs water and swells, it can improve the overall tensile strength of the oral film product, facilitate the user to move the oral film product, and improve the usability of the oral film product.
[0235] According to an embodiment of the present application, the first sheet and the second sheet are the same. Thus, the release rate of the active ingredient on both surfaces of the oral film product is consistent.
[0236] According to an embodiment of the present application, in order to meet the requirements of different usage scenarios and enrich the user experience, the first sheet and the second sheet can have different properties, so as to achieve different usage experiences and usage effects. According to an embodiment of the present application, at least one of the water permeability, porosity, thickness, material, tensile strength, and number of layers of the first sheet and the second sheet is different. Thus, different release rates of the active ingredient can be provided on both surfaces of the oral film product, enriching the user experience and meeting the personalized usage needs of more usage scenarios and more users.
[0237] According to an embodiment of the present application, there is no particular limitation on the materials of the first sheet and the second sheet, as long as the usage requirements of the target position are met. For example, the first sheet and the second sheet can be made of a flexible material so that the oral film product can conform to the shape inside the oral cavity as much as possible, avoiding discomfort to the user.
[0238] Specifically, according to the different settings of the first sheet and the second sheet, the material selection is also different. If at least part of the oral film is not wrapped by the first sheet and the second sheet, there is no limitation on the water permeability of the first sheet and the second sheet. The first sheet and the second sheet can have water permeability or not. If the first sheet and the second sheet wrap the oral film completely, it is required that at least one of the first sheet and the second sheet has water permeability, or the first sheet and the second sheet do not have water permeability but are provided with water-permeable channels, such as through holes, openings, etc. provided on a plastic sheet without water permeability. Thus, it can be ensured that the active ingredients in the oral film can be effectively released and act on the target position.
[0239] According to an embodiment of the present application, the water-permeable channel includes a through hole, or includes a through hole and a porous layer detachably covered on the through hole. During use, the user can choose whether to open the porous layer. When the porous layer is opened, the active ingredients released by the oral film can be more absorbed by the target position through the through hole, obtaining a stronger stimulation. When the porous layer is not opened, the active ingredients released by the oral film need to pass through the porous layer and act on the target position, and the release speed of the active ingredients is relatively slow.
[0240] According to an embodiment of the present application, the first sheet and the second sheet each independently include at least one of non-woven fabric, special paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh cloth, woven fabric, foamed resin film, reticulated resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet provided with a water-permeable channel, and rubber sheet provided with a water-permeable channel. Thus, the sheet has good liquid permeability, which is beneficial for the oral film to contact with the liquid and release the active ingredients to act on the target position.
[0241] According to an embodiment of the present application, in order to better meet the usage requirements, the oral film can include a plurality of sub-oral films. The plurality of sub-oral films are the same, or at least one of the types and concentrations of the active ingredients contained in the plurality of sub-oral films is different. Thus, in the case where the thickness of a single oral film is limited, a larger thickness and a larger dose of active ingredients can be achieved by providing a plurality of sub-oral films. When the plurality of sub-oral films are different, the oral film product can have multiple effects or different usage experiences. Specifically, if the active ingredients in the plurality of sub-oral films are different, different usage effects can be achieved, and if the concentrations of the active ingredients in the plurality of sub-oral films are different, different active ingredient release speeds can be achieved at different stages during use, enriching the user's experience and usage effect.
[0242] According to an embodiment of the present application, there is no particular limitation on the specific setting manner of the multiple sub-port films. They can be stacked or arranged flat in one plane. In some embodiments, the sub-port film includes at least one of a first sub-port film and a second sub-port film. Among them, multiple first sub-films are stacked, and multiple second sub-port films are arranged flat on the first surface. Specifically, the port film can only include multiple first sub-port films; the port film can only include multiple second sub-port films; the port film can also include multiple first sub-port films and at least one second sub-port film at the same time.
[0243] It can be understood that during the actual use of the port film product, the release of the active ingredient proceeds in the order from the outside to the inside and from the periphery to the middle. Based on this, by setting different components, different concentrations, and different setting manners of the sub-port film, a richer use experience and use effect can be achieved.
[0244] It should be noted that the description method "arranged flat in one plane" used herein can be arranged flat in a plane or arranged flat in a curved surface.
[0245] According to an embodiment of the present application, adjacent first sub-port films are detachably connected; and / or the second sub-port film is detachably connected to the sheet. Thus, the user can flexibly adjust the types and quantities of the sub-functional film sheets according to personal actual needs, better meeting the personalized needs of the user.
[0246] According to an embodiment of the present application, the first sub-port film is provided with a seventh detachment portion. Thus, the user can conveniently tear off the first sub-port film through the seventh detachment portion, better meeting the personalized needs of the user.
[0247] According to an embodiment of the present application, the partial edges of two connected first sub-port films are not sealed. Thus, the user can clearly identify the number of layers of the first sub-port film through the unsealed position and can hold the unsealed position to tear off the first sub-port film.
[0248] According to an embodiment of the present application, the second sub-port film is provided with an eighth detachment portion. Thus, the user can conveniently tear off the second sub-port film through the eighth detachment portion, better meeting the personalized needs of the user.
[0249] According to an embodiment of the present application, the partial edges of the second sub-port film and the sheet are not sealed. Thus, the user can clearly identify the number of layers of the second sub-port film through the unsealed position and can hold the unsealed position to tear off the second sub-port film.
[0250] According to an embodiment of the present application, the first sheet includes a plurality of third sub-sheets, the plurality of third sub-sheets are parallel to the first surface, and the orthographic projection of each third sub-sheet on the first surface overlaps with the orthographic projection of at least one second sub-mouth film on the first surface; at least one of the water permeability, material, porosity, tensile strength, thickness, and number of layers of the plurality of third sub-sheets is different. Thus, different second sub-mouth films can have different active ingredient release rates, better meeting user needs and enriching the user experience.
[0251] According to an embodiment of the present application, the sheet further includes at least one third sheet, and the third sheet is sandwiched between two adjacent layers of the first sub-mouth film. Thus, the third sheet can play an isolation role between the adjacent first sub-mouth films, and at the same time, the release of the active ingredient by the third sheet will also increase a certain resistance, which can achieve the effect of adjusting the release rate of the active ingredient.
[0252] According to an embodiment of the present application, at least one of the water permeability, material, porosity, thickness, tensile strength, and number of layers of the plurality of third sheets is different. Thus, due to the different above parameters of the third sheet, the resistance of the active ingredient passing through the third sheet is different, and thus different active ingredient release rates can be achieved, enriching the user experience.
[0253] According to an embodiment of the present application, the oral film product may further include a holding part. Thus, the user can conveniently move the oral film product by hand holding the holding part, so that it can be accurately placed at the target position during use, and can be taken out in advance during use by hand holding the holding part, enabling the oral film product to adapt to diverse usage requirements and greatly improving the usability of the oral film product.
[0254] According to an embodiment of the present application, the specific form of the holding part may not be particularly limited as long as it is convenient to hold during the process of fitting the oral film product. In some embodiments, the holding part includes at least one of a traction line and a handle. Specifically, a traction line can be sewn or pasted on the sheet to form a structure similar to a tea bag; or the handle can be formed by the sheet or the sheet and the oral film together. Thus, the structure is simple and easy to use.
[0255] According to an embodiment of the present application, the holding part is located at the edge of the oral film product. Specifically, the holding part can be located at one end of the oral film product, opposite ends, or multiple spaced holding parts can be provided on one side edge of the oral film product, etc. Thus, the oral film product can be moved more flexibly through the holding part, thereby improving the mobility of the oral film product and being more convenient for preparation and use.
[0256] According to an embodiment of the present application, the holding part is composed of a sheet, or jointly composed of a sheet and an oral film. Specifically, by providing the sheet, the tensile resistance of the oral film product is enhanced and the mechanical strength is higher, and a part of the oral film product, that is, the sheet and the oral film jointly constitute the holding part; in some other embodiments, the sheet can exceed a part of the oral film, and the exceeding part constitutes the holding part.
[0257] According to an embodiment of the present application, graphic and text information is printed on the oral film product. Thereby, it is convenient to use. Specifically, the graphic and text information can include any information such as pictures, textures, and characters. As an example, the graphic and text information can include the type of active ingredient of the oral film, the concentration of the active ingredient, the taste, the expiration date, the instructions for use, the brand logo, and so on. Users can identify the uses, dosages, etc. of the oral film product according to the graphic and text information such as the type of active ingredient, the concentration of the active ingredient, the taste, etc.; the brand logo is suitable for merchants to establish brand awareness; and the decorative pattern can increase the aesthetic feeling of the appearance of the oral film product.
[0258] Specifically, the graphic and text information can be formed on the sheet, or can be formed on the sheet and the oral film at the same time. In some embodiments, the graphic and text information can be printed, or can be the traces formed by ultrasonic embossing. The traces (characters, patterns) can include at least one of indentations, protrusions, and hollowings, and the traces can be used to represent the graphic and text information.
[0259] According to an embodiment of the present application, the outer contour shape of the oral film includes at least one of a square, a rectangle, a circle, a triangle, and a polygon. It can be understood that the shape of the oral film can be designed according to ergonomics and convenience for different use parts. For example, the mucosal positions such as the buccal film and the sublingual film are wide, and circular or square oral film products can be used. For the gums, a narrow and long oral film product can be used, and for the alveolar ridge, a wider oral film product can be used, and so on.
[0260] According to an embodiment of the present application, the maximum size of the outer contour of the oral film product is 0.1 - 8 cm (specifically, such as 0.1 cm, 0.5 cm, 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm, 7 cm, 7.5 cm, 8 cm, etc.), and the minimum size is 0.1 - 1.5 cm (specifically, such as 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 0.6 cm, 0.7 cm, 0.8 cm, 0.9 cm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.4 cm, 1.5 cm, etc.). It should be noted that the maximum size refers to the maximum distance between any two points on the outer contour line of the oral film product, and the minimum size refers to the minimum distance between any two points on the outer contour line of the oral film product. Within the above size range, the use requirements of different parts of the oral cavity can be met.
[0261] According to an embodiment of the present application, the oral film includes at least one of a completely dissolvable film layer, a partially dissolvable film layer, or a swelling film layer. Specifically, the oral film product provided by the present application can adopt the above different types of film layers, with a wider range of usage functions, and can meet the usage requirements of different usage scenarios, and has higher usage convenience.
[0262] It should be noted that the main difference between the completely dissolvable film layer, the partially dissolvable film layer, and the swelling film layer is the swelling rate. The completely dissolvable film layer has the lowest swelling rate, the swelling rate of the partially dissolvable film layer is between that of the completely dissolvable film layer and the swelling film layer, and the swelling film layer can be a hydrogel.
[0263] Therefore, the oral film product has a wide range of uses and can meet the needs of diverse usage scenarios.
[0264] The embodiments of the present application will be described in detail below.
[0265] Example 1
[0266] Provide a slow-release nicotine functional film layer (FASTA, commercially available from Shenzhen Wuxin Technology Co., Ltd., see photo Figure 24 ): The nicotine content is 4 mg / pcs, the tablet weight is 70 mg, the thickness is 120 μm, the length is 3 cm, the width is 1 cm, and the main film-forming agents are pullulan, gelatin, PEG, water, nicotine, and flavoring substances.
[0267] In the experimental group, the nicotine functional film layer was completely enclosed in a permeable fabric, and two non-woven fabrics, n1 (FDA30, commercially available from Huzhou Ruilan New Materials Co., Ltd.) and n2 (FDA34, commercially available from Huzhou Ruilan New Materials Co., Ltd.), as well as polylactic acid film (S05020, commercially available from Dongguan Rifu Fiber Co., Ltd.), special paper (product number 789, Guangzhou Xili Industrial Co., Ltd.), and food-grade nylon filter mesh (product number HN-NLWD, Zhejiang Huarui Mesh Co., Ltd.) were used for encapsulation respectively to obtain multiple oral film products, which were respectively set as the n1 oral film product group (see photo Figure 25 ), the n2 oral film product group (see photo Figure 26 ), the polylactic acid film oral film product group, the special paper oral film product group, and the food-grade nylon filter mesh oral film product group. The control group was only the original nicotine functional film layer.
[0268] The physical and chemical parameters of n1 non-woven fabric, n2 non-woven fabric, polylactic acid film, special paper, and food-grade nylon filter mesh are as follows:
[0269]
[0270] Dissolution experiment method:
[0271] Place multiple oral film products on a mesh carrier and suspend them on the surface of the solution in a beaker containing 100 ml of artificial saliva, ensuring wetting. Place the beaker on a temperature-controlled magnetic stirrer, set it to 130 revolutions per minute and 37 degrees Celsius. At specified time points, such as 0.1 min, 0.3 min, 0.5 min, 1 min, 2 min, 3 min, 5 min, 8 min, 12 min, 18 min, 25 min, 35 min. Collect 100 μl of samples, measure the concentration of the active ingredient, calculate the dissolution amount of the active ingredient, combine with the content determination results, and draw a curve of the release characteristics of the active ingredient, see Figure 27 and Figure 28 .
[0272] It can be clearly seen from the dissolution data that after adding the non-woven fabric, the release of the nicotine active ingredient is more gentle, but the overall release rate is not greatly affected. Especially in the range of 0 - 1 min, there is no release in the experimental group within 30 s, and the release amount is relatively low at 1 min. It can be considered that this process is the non-woven fabric absorbing water and wetting, buffering the rapid release of the nicotine functional film layer in contact with saliva, and this process gives the user an opportunity to move the film to the optimal body feeling position.
[0273] Then, select the n1 oral film product that is closer to the release of the original nicotine functional film layer and conduct a user experience test with the original nicotine functional film layer:
[0274] Before starting, the subjects will be instructed on the correct attachment method:
[0275] First, ensure that the subject's hands are dry and there is no obvious liquid such as sweat, and then take out the film agent;
[0276] The subject holds the film with one hand and uses the other hand to lift or push open the buccal mucosa or the upper lip near the upper gum;
[0277] Attach the film agent to the gum and lower the buccal mucosa and lip;
[0278] Record the usage time, number of times, and number of movements when the subject successfully attaches to the gum and buccal mucosa. Interview the subject about the convenience of use, the feeling of adhesion (the stronger the sticky feeling, the lower the score), the time when nicotine takes effect, the irritation of the throat, and ask the subject to record the experience during use and score it from 0 to 6 points. Among them, the stronger the sticky feeling, the lower the score, and the better the convenience, the higher the score.
[0279]
[0280]
[0281]
[0282] Generally speaking, during the attachment process, the subject needs to move 2 to 3 times. When adding non-woven fabric, almost all subjects can attach a film product to the appropriate position with just one. Without adding non-woven fabric, the subject is allowed to move once on average, and the user needs to waste 1.83 original nicotine functional film layers before they may be able to attach it to the appropriate position. After adding non-woven fabric, the time it takes for nicotine to take effect is slowed down by 1.5 minutes, improving the convenience for users to withdraw midway and achieving a certain sustained-release and controlled-release effect.
[0283] Since non-woven fabric has a certain water retention property, after adding non-woven fabric, it can reduce the phenomenon that the nicotine functional film layer dissolves rapidly with saliva and enters the throat, causing strong irritation. Adding non-woven fabric greatly improves the convenience of use and reduces the discomfort caused by the adhesiveness and residue of the nicotine film product.
[0284] Example 2
[0285] In the experimental group, a commercially available propolis film was completely enclosed in a non-woven fabric. Photos of the propolis oral film product after being wrapped by the propolis film and non-woven fabric can be seen in Figure 29 and Figure 30 , respectively. For this test, the subject needs to take out the propolis oral film product and attach it to the position of the buccal mucosa in the oral cavity. The target position of the propolis oral film product is the oral ulcer, and the position is as shown in Figure 31 .
[0286] Six subjects were counted to see how many times they could successfully attach to the target position.
[0287] Original propolis film Propolis oral film product Subject 1 3 1 Subject 2 2 1 Subject 3 3 1 Subject 4 1 1 Subject 5 4 1 Subject 6 1 1 Average 2.33
[0288] After adding a permeable non-woven fabric, it is easier for users to attach the oral film product to the appropriate position. When directly using the original propolis film, most subjects have difficulty because the original propolis film becomes damp and deformed after entering the oral cavity, sticks to the hand, and is difficult to separate, making it impossible to place it in the target position. Or after multiple attempts, the film absorbs water and breaks.
[0289] Example 3
[0290] A soluble dental film (photos can be seen in Figure 32 ), and a non-fully enclosed non-woven fabric sleeve was added to the dental film (photos can be seen in Figure 33 ) to obtain a dental film product, and the attachment position is the lower tooth surface.
[0291] The number of times the subject completed a successful attachment was counted.
[0292] Original dental film Dental film product Subject 1 3 1 Subject 2 4 1 Subject 3 2 1 Subject 4 1 1 Subject 5 3 1 Subject 6 2 1 Average 2.5 1
[0293] Adding a non-woven fabric sleeve can better protect the dental film from sticking to the inner side of the lip during the attachment process, reducing waste caused by curling and sticking of the dental film to the inner side of the lip or the gums during the attachment process, and greatly facilitating the use by the subjects.
[0294] Example 4
[0295] Experimental group: Ten nicotine functional film layers in Example 1 wrapped with non-woven fabric were further placed into a barrier aluminum foil bag for encapsulation.
[0296] Control group: Ten nicotine functional film layers in Example 1 without being wrapped with non-woven fabric were directly encapsulated into an aluminum foil bag.
[0297] Both the experimental group and the control group were placed in a constant temperature and humidity chamber (37 °C and 75% humidity) for testing.
[0298] After 45 days of testing, it was found that the nicotine functional film layers in the control group had adhered together and could not be peeled off, while those in the experimental group could be well dispersed and peeled off.
[0299] Example 5
[0300] Using the nicotine functional film layer in Example 1, the above-mentioned nicotine functional film layer was encapsulated in different forms with non-woven fabric, specifically as follows:
[0301] The non-woven fabric forms a bag-like structure with a single-sided opening, and the nicotine orally dissolving film is entirely accommodated in the accommodation space of the bag-like structure. See the photo at Figure 34 ;
[0302] The non-woven fabric forms a bag-like structure with openings on opposite sides, and the nicotine orally dissolving film is entirely accommodated in the accommodation space of the bag-like structure. See the photo at Figure 35 ;
[0303] The non-woven fabric forms a bag-like structure with openings on opposite sides, and the middle part of the nicotine orally dissolving film is accommodated in the accommodation space of the bag-like structure, with both ends extending beyond the non-woven fabric. See the photo at Figure 36 ;
[0304] The non-woven fabric forms a bag-like structure with a single-sided opening, and a part of the nicotine orally dissolving film is accommodated in the accommodation space of the bag-like structure, with one end extending beyond the non-woven fabric from the opening. See the photo at Figure 37 ;
[0305] The non-woven fabric forms a bag-like structure with no openings around, and the nicotine orally dissolving film is accommodated in the accommodation space of the bag-like structure. Three openings are provided on one surface of the bag-like structure. See the photo at Figure 38 .
[0306] Example 6
[0307] Provide a swollen oral film (see the photo atFigure 39 After sufficient contact with water, the swollen oral film presents a uniform swelling into a gel state. The nicotine content is 2 mg / piece, the tablet weight is 70 mg, the thickness is 120 μm, the length is 3 cm, the width is 1 cm, and the main film-forming agents are chitosan, gelatin, PEG, water, nicotine, and flavoring substances.
[0308] The oral film is encapsulated in non-woven fabric by ultrasonic encapsulation to obtain oral film products of different shapes. See the photos in Figure 40 , Figure 41 and Figure 42 . As can be seen from the figure, the obtained oral film products are printed with graphic and text information such as different brand logos.
[0309] When the above-mentioned oral film and the oral film product encapsulated in non-woven fabric are partially contacted with water, it can be found that when the above-mentioned original oral film is partially contacted with water, local shrinkage is likely to occur (see the photo in Figure 43 ). If it is encapsulated by non-woven fabric, the water can be evenly diffused, the shrinkage and agglomeration caused by uneven swelling can be reduced, and at the same time, the rigidity of the oral film can be improved, and the problems caused by the shrinkage of the oral film can also be improved.
[0310] Example 7
[0311] A common plastic film with a thickness of 100 μm and mainly composed of polyethylene is used. Holes (i.e., water-permeable channels) are formed on the surface layer as needed. Then, a hot air blower or an ultrasonic encapsulation machine is used to encapsulate the nicotine functional film layer in Example 1 in the plastic film.
[0312] Example 8
[0313] A slow-soluble dental film is provided (a dental film launched by Qingjiuye, which uses bioactive enzymes such as papain and catalase as the main active ingredients to act on the bacteria on the tooth surface to achieve a whitening effect. The recommended use time is 30 min - 1 hour). After being sewn with non-woven fabric, a dental film product is obtained. Among them, both opposite ends of the non-woven fabric extend beyond a part of the dental film to form a holding part, so as to avoid direct contact between the hand and the dental film, reduce the influence of hand body fluids on the dental film, and even damage the dental film itself. And it is convenient for users to move the dental film after fitting.
[0314] Six subjects were counted to use 3 samples each, which were attached to the upper teeth, and the number of times when the holding part did not shrink and deform and was well attached was recorded.
[0315] The subjects were not restricted from making slight movements to facilitate good fitting.
[0316] Original dental film Dental film product Subject 1 1 3 Subject 2 0 3 Subject 3 2 2 Subject 4 1 3 Subject 5 0 3 Subject 6 1 3 Average 0.83 2.83
[0317] After adding the holding part, users can move the dental film product very well and fit it smoothly, and the holding part is hardly damaged. Even if the subject needs to move to fit it well, the requirement can still be met.
[0318] Example 9
[0319] Provide special paper (same as in Example 1), with the composition of wood pulp and a small amount of food-grade heat-sealing material, polypropylene. Use ultrasonic encapsulation and pattern welding, and internally encapsulate a nicotine functional film layer in Example 1. The photo of the obtained nasal film product is shown in Figure 44 , the diameter of the disc-shaped nasal film product is 0.8 cm and the thickness is 120 μm.
[0320] Subjects used the nasal film products with the original nicotine functional film layer and those encapsulated with special paper respectively, applied them to the nasal cavity for nicotine absorption and aroma perception, and withdrew after 10 minutes of use. Statistics were made on the nasal irritation, nicotine perception, withdrawability and convenience felt by the subjects.
[0321]
[0322]
[0323] After being encapsulated with special paper, the nasal film product can be applied to the inner part of the nasal cavity with the help of a small amount of nasal mucus. When the special paper is moved, it is not damaged. At the same time, due to its good moisture buffering function, it promotes the early water absorption of the nicotine functional film layer, helps the nicotine functional film layer to swell, dissolve, and reduces the liquid dissolved in the nicotine functional film layer from dripping into the nasal cavity to cause discomfort through its water storage and encapsulation functions. At the same time, the nicotine perception of the subjects is slightly slower than that of the original nicotine functional film layer, more comfortable, and avoids adverse reactions caused by excessive nicotine intake.
[0324] Example 10
[0325] For the dental film in the same implementation case 8, sandwich the dental film between a plastic film mainly composed of polypropylene (product number - DYM002, food wrap, Dongguan Mingye Packaging Products Co., Ltd.) and a 25g polylactic acid film with permeability, and perform full encapsulation to obtain a dental film product.
[0326] During the use by the subjects, the degree of the active ingredient acting on the tooth surface was examined, mainly using the whiteness of the teeth becoming white after the subjects used the product for 30 minutes according to the operation instructions as an index.
[0327] Dental film product Original dental film Subject 1 4 3 Subject 2 5 4 Subject 3 3.5 2 Subject 4 3 3 Subject 5 4 2.5 Subject 6 4 3 Average 3.91 2.91
[0328] Since a completely impermeable plastic film is used on one side, the active ingredients of the dental film are successfully prevented from contacting the lip part and from flowing into non-tooth parts through excessive saliva. A polylactic acid film is used on the other side. This film has water permeability, can permeate saliva, helps dissolve the dental film, and at the same time slows down the outflow rate of the active ingredients, enabling the active ingredients to act on the tooth surface for a longer time, which is beneficial for the effect to be exerted.
[0329] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation of the present invention.
[0330] In addition, the terms "first" and "second" are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present invention, the meaning of "plural" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.
[0331] In the present invention, unless otherwise clearly specified and limited, the terms such as "installed", "connected", "connected to", "fixed" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection, an electrical connection, or communicable with each other; it may be directly connected, or indirectly connected through an intermediate medium, and it may be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
[0332] In the present invention, unless otherwise clearly specified and limited, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on" the second feature may be that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "under" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature has a lower horizontal height than the second feature.
[0333] In the description of this specification, the descriptions referring to terms such as "one embodiment", "some embodiments", "examples", "specific examples", or "some examples", etc., mean that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, without contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.
[0334] Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those of ordinary skill in the art can make changes, modifications, substitutions, and variations to the above embodiments within the scope of the present invention.
Claims
1. A film product, characterized in that: The film product comprises: A functional film layer, wherein the functional film layer contains an active ingredient, and the active ingredient is suitable for being released from the functional film layer and acting on a target location; The sheet layer includes a first sheet layer, the first sheet layer is arranged on at least a portion of the surface of the functional film layer; and / or the first sheet layer is embedded in the functional film layer.
2. The film product according to claim 1, characterized in that: The first sheet layer covers one side surface of the functional film layer.
3. The film product according to claim 1, characterized in that: The sheet layer further includes a second sheet layer, and the first sheet layer and the second sheet layer are arranged on two opposite surfaces of the functional film layer.
4. The film product according to claim 3, characterized in that: The edges of at least two of the first sheet layer, the functional film layer and the second sheet layer are aligned.
5. The film product according to claim 3, characterized in that: The film product meets any one of the following conditions: The first sheet layer and the second sheet layer are partially connected at their edges to form a first bag-like structure with an opening at least on one edge, a first accommodation space is provided in the first bag-like structure, and at least part of the functional film layer is arranged in the first accommodation space; The first sheet layer and the second sheet layer are connected at their edges to jointly form a second bag-like structure without an opening at the edge; a second accommodation space is provided in the second bag-like structure, and the functional film layer is accommodated in the second accommodation space.
6. The film product according to claim 3, characterized in that: At least one of the first sheet layer and the second sheet layer is provided with a first opening.
7. The film product according to claim 3, characterized in that: The film product meets at least one of the following conditions: The first sheet layer includes a plurality of first sub-sheet layers stacked in layers; The second sheet layer includes a plurality of second sub-sheet layers stacked together.
8. The film product according to claim 7, characterized in that: Adjacent first sub-sheet layers are detachably connected to each other; and / or adjacent second sub-sheet layers are detachably connected to each other.
9. The film product according to claim 8, characterized in that: The film product meets at least one of the following conditions: The first sub-sheet layer is provided with a first disassembly portion; The edges of two connected first sub-sheet layers are not sealed; The second sub-sheet layer is provided with a second disassembly portion; The edges of two connected second sub-sheet layers are not sealed.
10. The film product according to claim 3, characterized in that: The film product meets at least one of the following conditions: The first sheet layer includes a first detachable area and a first non-detachable area, and the first detachable area is connected to the first non-detachable area via a first weak connection structure; The second sheet layer includes a second detachable area and a second non-detachable area, and the second detachable area is connected to the second non-detachable area via a second weak connection structure.
11. The film product according to claim 3, characterized in that: The film product further includes: a waterproof layer, and the waterproof layer satisfies any one of the following conditions: The film product comprises the functional film layer and the first sheet layer, and the waterproof layer is arranged on the surface of the first sheet layer away from the functional film layer or on the surface of the functional film layer not covered by the first sheet layer; The film product includes the functional film layer, the first sheet layer and the second sheet layer, the functional film layer is sandwiched between the first sheet layer and the second sheet layer, and the waterproof layer is arranged on at least one of the surface of the first sheet layer away from the functional film layer, the surface of the second sheet layer away from the functional film layer, and the surface of the functional film layer not covered by the first sheet layer and the second sheet layer.
12. The film product according to claim 3, characterized in that: The film product further includes: a water-swellable substance, wherein the water-swellable substance is disposed on at least one of the following positions: a surface of the first sheet layer; a surface of the second sheet layer; In the pores of the first sheet; The second sheet is in the pores.
13. The film product according to claim 3, characterized in that: The film product meets any one of the following conditions: The first sheet layer and the second sheet layer are the same; The first sheet layer and the second sheet layer are different in at least one of water permeability, porosity, thickness, material, tensile strength and number of layers.
14. The film product according to claim 3, characterized in that: The first sheet layer and the second sheet layer each independently satisfy any one of the following conditions: Water permeable; It is not water-permeable and is provided with a water-permeable channel.
15. The film product according to claim 14, characterized in that: The water permeable channel includes a through hole, or the water permeable channel includes the through hole and a porous layer detachably covering the through hole.
16. The film product according to claim 14, characterized in that: The first sheet layer and the second sheet layer each independently include at least one of non-woven fabric, special paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh cloth, foamed resin film, mesh resin film, porous resin film, swellable sheet, swellable net, plastic sheet provided with the water permeable channel, and rubber sheet provided with the water permeable channel.
17. The film product according to claim 1, characterized in that: The functional film layer includes a plurality of sub-functional film layers, and the plurality of sub-functional film layers are the same; or The multiple sub-functional film layers contain at least one of the type and concentration of the active ingredients different from each other, and the sub-functional film layers include at least one of a first sub-functional film layer and a second sub-functional film layer, wherein the multiple first sub-functional film layers are stacked, and / or the multiple second sub-functional film layers are arranged flat on the first surface.
18. The film product according to claim 17, characterized in that: Adjacent first sub-functional film layers are detachably connected to each other; and / or the second sub-functional film layer and the sheet layer are detachably connected to each other.
19. The film product according to claim 18, characterized in that: The film product meets at least one of the following conditions: The first sub-functional film layer is provided with a third disassembly portion; Partial edges of two connected first sub-functional film layers are not sealed; The second sub-functional film layer is provided with a fourth disassembly portion; Part of the edges of the second sub-functional film layer and the sheet layer are not sealed.
20. The film product according to claim 17 or 18, characterized in that: The first sheet layer includes a plurality of third sub-sheet layers, the plurality of third sub-sheet layers are substantially parallel to the first surface, and an orthographic projection of each of the third sub-sheet layers on the first surface has an overlapping area with an orthographic projection of at least one of the second sub-functional film layers on the first surface; and at least one of the water permeability, material, porosity, tensile strength, thickness and number of layers of the plurality of third sub-sheet layers is different.
21. The film product according to claim 17, characterized in that: The sheet layer further includes at least one third sheet layer, and the third sheet layer is sandwiched between two adjacent layers of the first sub-functional film layer.
22. The film product according to claim 21, characterized in that: The plurality of third sheets have different water permeability, material, porosity, thickness, tensile strength and number of layers.
23. The film product according to claim 1, characterized in that: The film product also includes a grip portion.
24. The film product according to claim 23, characterized in that: The grip portion satisfies at least one of the following conditions: The gripping portion includes at least one of a traction line and a gripping handle; The gripping portion is located at the edge of the film product; The gripping portion includes a portion of the sheet layer; The holding portion includes a portion of the sheet layer and a portion of the functional film layer.
25. The film product according to claim 1, characterized in that: Graphic information is printed on the film product.
26. The film product according to claim 1, characterized in that: The film product includes at least one of a buccal film product, a sublingual film product, a supralingual film product, an oral cavity wall film product, a gingival film product, a tooth film product, and a nasal film product.
27. The film product according to claim 1, characterized in that: The film product meets at least one of the following conditions: The outer contour shape of the film product includes at least one of a square, a rectangle, a circle, a triangle, a polygon, and an irregular shape; The maximum dimension of the outer contour of the film product is 0.1 to 8 cm, and the minimum dimension is 0.1 to 1.5 cm; The functional film layer includes at least one of a fully dissolving film layer, a partially dissolving film layer, and a swelling film layer.
28. The film product according to claim 1, characterized in that: The active ingredient comprises at least one of a pharmaceutical ingredient, a nutritional health ingredient, a food ingredient, a daily chemical ingredient, and an alkaloid.
29. The film product according to claim 28, characterized in that: The drug ingredients include at least one of oral ulcer drugs, psychotropic drugs, analgesics, anti-inflammatory drugs, nasal drugs, cannabinoids and their derivatives, respiratory drugs, and sildenafil; The nutritional health care ingredients include at least one of American ginseng extract, Schisandra chinensis extract, Ganoderma lucidum extract, arginine, propolis, melatonin, glutathione, and taurine; The food ingredients include at least one of tea extract, coffee extract and vitamins; The daily chemical ingredients include at least one of papain, catalase, teeth whitening ingredients, oral repair ingredients, and anti-aging ingredients; The alkaloids include at least one of nicotine and its derivatives, caffeine and its analogs, arecoline and its analogs, and hexamethylnicotine.
30. An oral film product, characterized in that: The oral film product comprises: An oral film containing an active ingredient, wherein the active ingredient can be released from the oral film and act on a target site; Sheets, the sheet materials comprising a first sheet material, the first sheet material being arranged on at least a portion of the surface of the oral membrane; and / or the first sheet material being embedded in the interior of the oral membrane; The sheet material is the same as the sheet layer defined in any one of claims 1 to 27, and the oral film is the same as the functional film layer defined in any one of claims 1 to 25 and 27 to 28.
Citation Information
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