Oral products and methods for their manufacture

Abstract

This application discloses a mouth-held product and its preparation method, relating to the field of food technology. The mouth-held product includes a substrate and a printed layer. The substrate includes a first support layer, a second support layer, and a functional layer, wherein the functional layer is located between the first and second support layers, at least one of the first and second support layers is a water-permeable layer, and the functional layer includes an active agent. The printed layer is formed on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer. The printed layer includes a printed logo, includes starch and / or starch derivatives, and is orally dissipable. The embodiments of this application can improve the recognizability of the mouth-held product while improving the uniformity of the distribution of the active agent and the consistency of the mouthfeel during oral use.

Description

Technical Field

[0001] This application relates to the field of food technology, specifically to a mouth-held product and its preparation method. Background Technology

[0002] With the widespread use of oral care products in oral care, health care, nicotine replacement and nutritional supplementation, the visual distinctiveness of oral care products has gradually gained attention.

[0003] In related technologies, molds are generally used to press the functional layer surface of oral products to prepare patterns on the functional layer surface. However, during the pressing process of the functional layer surface using molds, the pressing pressure will cause the functional layer to be compressed and deformed, resulting in a decrease in the uniformity of the distribution of active ingredients in the functional layer, which in turn leads to a decrease in the oral taste of the oral product. Summary of the Invention

[0004] This application provides a mouth-held product and its preparation method, which solves the problem that the preparation of patterns directly on the surface of the functional layer of the mouth-held product in related technologies leads to a decrease in the uniformity of the distribution of active ingredients in the mouth-held product and a decrease in mouth-held taste.

[0005] To address the aforementioned technical problems, this application provides a mouthpiece comprising a substrate and a printed layer; the substrate comprises a first support layer, a second support layer, and a functional layer, wherein the functional layer is located between the first support layer and the second support layer, at least one of the first support layer and the second support layer is a water-permeable layer, the functional layer comprises an active agent, and the printed layer is formed on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer; the printed layer includes a printed logo, the printed layer comprises starch and / or a starch derivative, and the printed layer is orally dissipable.

[0006] In one embodiment, the printed layer further includes a colloid; and / or, the printed layer further includes at least one of a plasticizer, a stabilizer, a disintegrant, and a food coloring; and / or, the printed layer is adhered to the outer surface of the substrate; and / or, the thickness of the printed layer is 0.05 mm to 0.15 mm.

[0007] In one embodiment, the starch comprises at least one selected from corn starch, potato starch, tapioca starch, rice starch, wheat starch, and sweet potato starch; and / or, the starch derivative comprises at least one selected from hydroxypropyl starch phosphate, sodium carboxymethyl starch, starch acetate, cross-linked starch, hydroxypropyl starch, oxidized starch, pregelatinized starch, and cyclodextrin; and / or, the activator comprises at least one selected from nicotine and nicotine derivatives; and / or, the colloid comprises gelatin, pectin, carrageenan, gum arabic, xanthan gum, guar gum, chitosan, and alginate. The plasticizer comprises at least one of sodium, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl starch phosphate, methylcellulose, hydroxypropyl starch, sodium carboxymethyl starch, polyvinylpyrrolidone, polyethylene glycol, sodium polyacrylate, and povidone-iodine; and / or the plasticizer comprises at least one of glycerol, sodium hyaluronate, and propylene glycol; and / or the stabilizer comprises at least one of sodium alginate, xanthan gum, and microcrystalline cellulose; and / or the disintegrant comprises at least one of crospovidone, sodium carboxymethyl starch, crospovidone carboxymethyl cellulose, and hydroxypropyl cellulose.

[0008] In one embodiment, the relative deviation of the surfactant content in the functional layer is less than or equal to 5%; and / or the water content of the oral product is less than or equal to 10%.

[0009] In one embodiment, the functional layer includes at least two sub-functional layers.

[0010] In one embodiment, a waterproof layer is also provided between adjacent sub-functional layers.

[0011] In one embodiment, the thickness of the waterproof layer is 0.15mm to 0.25mm; and / or, the thickness of the functional layer is 0.15mm to 0.3mm; and / or, the thickness of the first support layer is 0.1mm to 0.12mm; and / or, the thickness of the second support layer is 0.1mm to 0.12mm; and / or, the thickness of the sub-functional layer is 0.15mm to 0.3mm.

[0012] In one embodiment, the functional layer further includes a film-forming substrate; and / or, the functional layer further includes at least one of a filler, an antioxidant, a flavoring agent, a plasticizer, and a pH adjuster.

[0013] This application also provides a method for preparing a mouthpiece, for preparing the mouthpiece as described above, the method comprising: obtaining a substrate, the substrate comprising a first support layer, a second support layer and a functional layer, the functional layer being located between the first support layer and the second support layer, at least one of the first support layer and the second support layer being a water-permeable layer, the functional layer comprising an active agent; obtaining a printing layer paste, the printing layer paste comprising starch and / or starch derivatives; using the printing layer paste, forming a printing layer on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer to obtain the mouthpiece, wherein the printing layer comprises a printed mark and the printing layer is orally dissipable.

[0014] In one embodiment, forming a printed layer on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer using the printing layer paste includes: applying the printing layer paste to the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer to form a coating layer; subjecting the coating layer to a first curing treatment to obtain a first cured layer; performing a first embossing treatment on the outer surface of the first cured layer to prepare the printed mark on the outer surface of the first cured layer to obtain a first printed cured layer; and subjecting the first printed cured layer to a second curing treatment. The printing layer is obtained by processing the printing paste into a film; or, the printing paste is cast into a film to obtain a cast film; the cast film is subjected to a third curing treatment to obtain a second cured layer; a second embossing treatment is performed on either side of the second cured layer to prepare the printed mark on the second cured layer to obtain a second printed cured layer; the second printed cured layer is laminated with the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer, and a fourth curing treatment is performed to form the printing layer on the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer.

[0015] The oral article provided in this application includes a substrate and a printed layer. The substrate includes a first support layer, a second support layer, and a functional layer. The functional layer is located between the first and second support layers. At least one of the first and second support layers is a water-permeable layer. The functional layer includes an active agent. The printed layer is formed on the outer surface of the first support layer facing away from the functional layer and / or the outer surface of the second support layer facing away from the functional layer. The first and second support layers provide mechanical support for the oral article. During the preparation of the printed markings in the printed layer, the first and second support layers can buffer the pressure applied to the functional layer, reduce the pressure transmitted to the functional layer, reduce the degree of deformation of the functional layer and the deviation in the content of the active agent caused by the deformation of the functional layer, improve the uniformity of the distribution of the active agent in the oral article, and ensure consistent taste during oral use. The first and second support layers are permeable layers, allowing saliva to penetrate into the functional layer and release the surfactants in the functional layer, providing users with surfactant satisfaction. The printed layer not only provides a carrier for the printed markings on the oral product, improving the recognizability of the oral product, but also the starch and / or starch derivatives in the printed layer can improve the mechanical strength of the printed layer, enabling the printed layer to withstand the pressure exerted on the oral product during the printing process, providing further mechanical support for the oral product, further improving the uniformity of surfactant distribution in the oral product and the consistency of taste during oral use. The printed layer has oral dissipability, allowing it to dissipate quickly during oral use, promoting the release process of surfactants in the functional layer, reducing the stickiness of the printed layer during oral use, and improving the oral taste of the oral product. Attached Figure Description

[0016] Figure 1 A cross-sectional structural diagram of a mouthpiece provided in this application Figure 1 ; Figure 2 A cross-sectional structural diagram of a mouthpiece provided in this application Figure 2 ; Figure 3 A cross-sectional structural diagram of a mouthpiece provided in this application Figure 3 ; Figure 4 A cross-sectional structural diagram of a mouthpiece provided in this application Figure 4 ; Figure 5 A cross-sectional structural diagram of a mouthpiece provided in this application Figure 5 ; Figure 6 A flowchart illustrating the steps of a method for preparing an oral product provided in this application.

[0017] Explanation of reference numerals in the attached figures: 10-Oral product; 11-Matrix; 111-First support layer; 112-Second support layer; 113-Functional layer; 1131-Sub-functional layer; 12-Printed layer; 13-Waterproof layer. Detailed Implementation

[0018] The present application will now be described in further detail with reference to specific embodiments and accompanying drawings. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other materials or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0019] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0020] The serial numbers assigned to components in this article, such as "first" and "second", are used only to distinguish the objects being described and have no sequential or technical meaning.

[0021] In related technologies, to improve the visual recognition of oral products, molds are generally used to press the functional layer surface of the oral product to form a pattern on the functional layer surface. However, during the pressing process of the functional layer surface using a mold, the pressing pressure will directly act on the functional layer containing active ingredients, causing the functional layer to be compressed and deformed. This will not only lead to uneven distribution of active ingredients in the functional layer, affecting the efficacy and consistency of active ingredients in the functional layer, but also lead to increased local density and decreased overall flexibility of the oral product, resulting in a decrease in the oral taste and oral comfort.

[0022] Furthermore, since oral products are relatively soft, during the process of pressing the surface of the functional layer using a mold, there may be a problem where the front is smooth but the back is wrinkled, resulting in a decrease in the appearance quality of the oral product.

[0023] In related technologies, patterns are also printed on the surface of oral products. For example, a xylitol-based printing process is used to print patterns on the surface of oral products. Although this method applies less printing pressure to the film containing the active ingredients, the hygroscopicity and fluidity of materials such as xylitol can lead to ink diffusion and blurred edges during the printing process, resulting in low resolution and unclear patterns. In addition, during storage and transportation, the printed patterns are prone to peeling or smearing due to friction, which not only affects the appearance of the oral product but also causes a foreign body sensation in the mouth due to the pattern peeling off, reducing the user's oral experience.

[0024] To address the aforementioned problems, this application provides a mouthpiece, as described in the embodiments below. Figures 1-3 The oral article 10 includes a base 11 and a printed layer 12.

[0025] The substrate 11 includes a first support layer 111, a second support layer 112 and a functional layer 113, wherein the functional layer 113 is located between the first support layer 111 and the second support layer 112, at least one of the first support layer 111 and the second support layer 112 is a water-permeable layer, and the functional layer 113 includes an active agent.

[0026] In some embodiments, both the first support layer 111 and the second support layer 112 are permeable layers; in some embodiments, the first support layer 111 is a permeable layer and the second support layer 112 is a non-permeable layer; in some embodiments, the first support layer 111 is a non-permeable layer and the second support layer 112 is a permeable layer. The permeable layer may include, but is not limited to, food-grade nonwoven fabric, permeable paper, porous fiber layer, porous membrane, woven fabric, nonwoven fabric, etc., while the non-permeable layer may include, but is not limited to, food-grade impermeable paper, food-grade plastic sheet, edible film, dense polymer membrane, etc.

[0027] The first support layer 111 and the second support layer 112 can provide mechanical support for the oral article 10. During the preparation of the printed markings in the printed layer 12, the first support layer 111 and the second support layer 112 can buffer the pressure applied to the functional layer 113, reduce the pressure transmitted to the functional layer 113, reduce the degree of deformation of the functional layer 113 and the deviation of the content of the active agent caused by the deformation of the functional layer 113, improve the uniformity of the distribution of the active agent in the oral article 10 and the consistency of the taste of the oral article 10 during the oral process. Furthermore, at least one of the first support layer 111 and the second support layer 112 is a water-permeable layer. The water-permeable layer is permeable, and liquids such as saliva can permeate from one side of the water-permeable layer 113 to the other side, thereby allowing saliva to contact the functional layer 113 and promoting the release of the active agent in the functional layer 113. In some embodiments, the permeable layer has a certain water-locking function, which can improve the uniformity of saliva distribution on the surface of the functional layer 113 and regulate the release rate of the active agent in the functional layer 113, thereby reducing oral discomfort caused by strong stimulation due to the excessively rapid release rate of the active agent. This can not only prolong the duration of action of the active agent, but also further improve the oral comfort of the oral product 10.

[0028] In some embodiments, the permeable layer 113 is a non-woven fabric. Non-woven fabric not only has water permeability and water-locking functions, but also skin-friendly properties, which can further improve the oral experience of the oral product 10. Furthermore, non-woven fabric has good durability in moist environments such as the oral cavity, which can improve the structural stability of the oral product 10 during oral use. In some embodiments, the non-woven fabric may include, but is not limited to, natural cellulose, synthetic cellulose, polyethylene terephthalate (PET), polyethylene (PE), etc.

[0029] In some embodiments, the active agent may include, but is not limited to, nicotine compounds, oral care agents, anti-inflammatory agents, nutritional supplements, etc. The functional layer 113 serves as a storage and release layer for the active agent. During the oral administration of the oral product 10, the orally dispersible / oral dissipating printed layer 12 rapidly dissipates, allowing saliva to permeate through the permeable layer to the functional layer 113. As the functional layer 113 disintegrates / dissolves / swells, the active agent dissolves in the saliva and reaches the oral mucosa, acting on the tissue cells of the oral mucosa to provide the user with a sense of satisfaction from the active agent, thereby achieving the expected therapeutic effect.

[0030] The printed layer 12 is formed on the outer surface of the first support layer 111 facing away from the functional layer 113 and / or the outer surface of the second support layer 112 facing away from the functional layer 113. In some embodiments, refer to… Figure 1The printed layer 12 is formed on the outer surface of the first support layer 111 opposite to the functional layer 113. In some embodiments, refer to Figure 2 The printed layer 12 is formed on the outer surface of the second support layer 112 opposite to the functional layer 113. In some embodiments, refer to Figure 3 The printed layer 12 is formed on the outer surface of the first support layer 111 opposite to the outer surface of the functional layer 113 and the second support layer 112 opposite to the outer surface of the functional layer 113.

[0031] The printed layer 12 includes a printed logo, comprises starch and / or starch derivatives, and is orally dispersible. Orally dispersible refers to the property that, upon placement in the oral environment, the printed layer 12 can undergo physical or chemical changes within a short time, transforming from a solid state to a liquid, particulate state, or completely disappearing, solely through the action of saliva (and slight tongue movements) without the need for additional drinking water. In some embodiments, orally dispersible properties include water solubility and / or disintegration.

[0032] In some embodiments, the printed mark in the printed layer 12 is disposed on the surface of the printed layer 12 facing away from the substrate 11. In some embodiments, the printed mark is a printed mark obtained by cold pressing on the surface of the printed layer 12 facing away from the substrate 11 using a printing mold. The edge of the printed mark has a high degree of sharpness and contrast, which can improve the clarity of the printed mark in the printed layer 12. Moreover, the printed mark is not prone to problems such as peeling and smearing during storage and transportation, and has high durability, which is beneficial to improving the appearance quality of the oral product 10 and enhancing the attractiveness and competitiveness of the oral product 10.

[0033] A printing mold is a mold with printed markings on its surface. Printed markings may include, but are not limited to, brand logos, anti-counterfeiting marks, place of origin marks, batch marks, efficacy marks, flavor marks, usage scenario marks, anti-slip textures, dosage marks, etc.

[0034] In some embodiments, the printing layer 12 includes starch and / or starch derivatives. The molecular chains of starch and / or starch derivatives contain a large number of active groups such as hydroxyl and carboxyl groups. During the film formation process of the printing layer 12, the active groups can form a dense three-dimensional network structure through at least one of hydrogen bonding, hydrophobic interaction, and chemical cross-linking, filling the internal pores of the printing layer 12 and enhancing the intermolecular bonding force of the printing layer 12. This improves the mechanical strength of the printing layer 12 without sacrificing its flexibility. Furthermore, the film formed after the starch and / or starch derivatives are formed has a uniform texture, which can reduce defects (e.g., micropores, cracks, etc.) inside the printing layer 12, improve the density of the printing layer 12, and thus enhance the mechanical stability of the printing layer 12. With the improved mechanical strength of the printed layer 12, the printed layer 12 located on the outside of the oral product 10 can provide further mechanical support for the oral product 10. During the preparation of the printed label, the printed layer 12 can bear the pressure acting on the oral product 10, reducing the pressure transmitted to the substrate 11, thereby further reducing the pressure on the functional layer 113 and the degree of deformation of the functional layer 113. This not only reduces the deviation in the content of the active agent caused by the deformation of the functional layer 113, but also improves the uniformity of the distribution of the active agent in the oral product 10 and the consistency of the mouthfeel during the oral process, ensuring that the therapeutic effect of the active agent is effectively exerted. It can also avoid the problem of local density increase of the substrate 11 under pressure, improve the flexibility of the oral product 10, improve the mouthfeel and oral comfort of the oral product 10, and, with the high mechanical strength of the printed layer 12, also reduce the problem of the oral product 10 being smooth on the front but wrinkled on the back, improving the smoothness and appearance quality of the outer surface of the oral product 10.

[0035] Furthermore, starch and / or starch derivatives can also give the printed layer 12 local rigidity and brittleness. Combined with cold pressing technology, clear and precise printed markings can be formed on the surface of the printed layer 12, thereby improving the appearance quality of the oral product 10.

[0036] In some embodiments, the printed layer 12 is a glutinous rice paper layer.

[0037] In some embodiments, the printed layer 12 has oral dissipability, which allows the printed layer 12 to dissolve and / or disintegrate rapidly during oral administration, reducing the obstruction to the release process of the active agent in the functional layer 113. Moreover, the homogeneous system formed during the dissipation of the printed layer 12 can promote the uniform diffusion of the active agent, thereby promoting the release process of the active agent in the functional layer 113. In addition, the rapid dissipation of the printed layer 12 during oral administration also reduces the unpleasant stickiness caused by the residue of the printed layer 12, which is beneficial to improving the oral smoothness and refreshingness of the oral product 10.

[0038] In some embodiments, the thickness of the printed layer 12 is 0.05 mm to 0.15 mm. This not only maintains the flexibility of the printed layer 12 but also improves its mechanical strength, reduces the pressure transmitted to the substrate 11 during the printing process, reduces the deformation of the functional layer 113 and the deviation in the content of the active agent caused by the deformation of the functional layer 113, and improves the uniformity of the distribution of the active agent in the oral product 10 and the consistency of the mouthfeel during oral use. In some embodiments, the thickness of the printed layer 12 can be one of 0.05 mm, 0.08 mm, 0.1 mm, 0.13 mm, and 0.15 mm, or any value between two of these.

[0039] In some embodiments, the thickness of the substrate 11 is 0.65 mm to 1.09 mm, which can increase the content of the active agent in the functional layer 113 and prolong the release time of the active agent in the oral article 10 while ensuring that the overall size of the oral article 10 meets the design requirements.

[0040] In some embodiments, the thickness of the oral article 10 is 0.75mm to 1.39mm, which can not only improve the mechanical strength of the oral article 10, but also reduce the foreign body sensation of the user during the oral process of holding the oral article 10 in their mouth, thereby improving the oral comfort of the oral article 10.

[0041] In some embodiments, the printed layer 12 further includes an colloid.

[0042] The colloid can include, but is not limited to, natural colloids, semi-synthetic colloids, and synthetic colloids. The colloid can form a double network gel structure with starch and / or starch derivatives through intermolecular forces. While improving the flexibility of the printing layer 12, it can also increase the mechanical strength of the printing layer 12 by a factor of two. This allows the printing layer 12 to effectively bear and buffer the instantaneous pressure generated during the preparation of the printed label, avoid damage to the printing layer 12 itself, reduce the pressure transmission to the substrate 11, reduce the degree of deformation of the functional layer 113 and the deviation of the surfactant content caused by the deformation of the functional layer 113, improve the uniformity of surfactant distribution in the oral product 10 and the consistency of taste of the oral product 10 during oral use.

[0043] In some embodiments, the colloid may include at least one of gelatin, pectin, carrageenan (CGN), gum arabic, xanthan gum (XG), guar gum, chitosan, sodium alginate (SA), hydroxypropyl methylcellulose (HPMC), sodium carboxymethylcellulose (CMC-Na), hydroxypropyl starch phosphate, methylcellulose (MC), hydroxypropyl starch, sodium carboxymethyl starch (CMS-Na), polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), sodium polyacrylate, and povidone iodine (PVP-I).

[0044] In some embodiments, the printed layer 12 further includes at least one of a plasticizer, a stabilizer, a disintegrant, and a food coloring.

[0045] The plasticizer can be embedded between the molecular chains of the dual network gel structure formed by the colloid and starch and / or starch derivatives, weakening the cohesive force of the dual network gel structure, further improving the flexibility and extensibility of the printing layer 12, while reducing the glass transition temperature of the printing layer 12, improving the processing fluidity of the printing layer 12, so that the printed logo prepared on the printing layer 12 can accurately replicate the logo texture of the printing mold, and improve the clarity and recognizability of the printed logo in the printing layer 12.

[0046] In some embodiments, the plasticizer includes at least one of glycerol (Gly), sodium hyaluronate (SH), and propylene glycol (PG).

[0047] Stabilizers are used to improve the stability of the printed layer 12 during storage and use, and to extend the duration of action of the printed layer 12.

[0048] In some embodiments, the stabilizer includes at least one of sodium alginate, xanthan gum, and microcrystalline cellulose (MCC).

[0049] The disintegrant can accelerate the penetration of saliva into the printed layer 12 through water absorption and swelling or capillary action after contact with saliva, destroy the film structure of the printed layer 12, promote the rapid breakage and dispersion of the molecular chains inside the printed layer 12, and shorten the dissipation time of the printed layer 12. At the same time, the disintegrant can also avoid the stickiness caused by the slow stretching of molecular chains and the gelatinization of starch and / or starch derivatives during the dissipation of the colloid in the printed layer 12, thereby improving the mouthfeel of the oral product 10.

[0050] In some embodiments, the disintegrant includes at least one of crosslinked polyvinylpyrrolidone (PVPP), sodium carboxymethyl starch, sodium crosslinked carboxymethyl cellulose (CCMC-Na), and hydroxypropyl cellulose (HPC).

[0051] Food coloring is used to develop the printed markings in the printed layer 12. The food coloring forms clear and bright printed markings by stably combining with the colloidal-starch composite matrix, further enhancing the recognizability of the oral product 10.

[0052] In some embodiments, the food coloring includes at least one of curcumin, carmine, beetroot red, sodium copper chlorophyll, gardenia yellow, gardenia blue, anthocyanin, carotene, shellac red, tartrazine (E102), sunset yellow (E110), amaranth (E123), allura red (E129), brilliant blue (E133), erythrosine (E127), and indigo (E132).

[0053] In some embodiments, starch includes at least one of corn starch, potato starch, tapioca starch, rice starch, wheat starch, and sweet potato starch.

[0054] In some embodiments, the starch derivative includes at least one of hydroxypropyl starch phosphate (HPSP), sodium carboxymethyl starch, starch acetate (SA), crosslinked starch (CLS), hydroxypropyl starch (HPS), oxidized starch (OS), pregelatinized starch (PGS), and cyclodextrin.

[0055] In some embodiments, the printed layer 12 comprises, by weight, 50 to 70 parts of starch and / or starch derivatives, 10 to 20 parts of plasticizer, 0.1 to 1.5 parts of stabilizer, and 20 to 30 parts of solvent.

[0056] In some embodiments, the printed layer 12 comprises, by weight, 45 to 60 parts of starch and / or starch derivatives, 5 to 15 parts of colloid, 8 to 15 parts of plasticizer, 0.5 to 2 parts of stabilizer, and 25 to 35 parts of solvent.

[0057] In some embodiments, the printed layer 12 comprises, by weight, 60 to 75 parts of starch and / or starch derivatives, 15 to 22 parts of colloid, 0.1 to 0.2 parts of disintegrant, and 25 to 35 parts of solvent.

[0058] In some embodiments, the printed layer 12 comprises, by weight, 45 to 60 parts of starch and / or starch derivatives, 5 to 15 parts of colloid, 8 to 15 parts of plasticizer, 0.5 to 2 parts of food coloring, and 25 to 35 parts of solvent.

[0059] In some embodiments, the printed layer 12 comprises, by weight parts, 45 to 75 parts of starch and / or starch derivatives, 5 to 22 parts of colloid, 8 to 15 parts of plasticizer, 0.1 to 2 parts of stabilizer, 0.1 to 0.2 parts of disintegrant, 0.5 to 2 parts of food coloring, and 20 to 35 parts of solvent.

[0060] In some embodiments, the active agent includes at least one of nicotine and nicotine derivatives. The nicotine derivatives may include at least one of nicotine salts, substituted nicotine, and substituted nicotine salts. Nicotine salts may include at least one of nicotine benzoate, nicotine lactate, nicotine citrate, nicotine malate, nicotine maleate, nicotine succinate, nicotine alicyclic carboxylate, nicotine acetylpropionate, nicotine gentianate, and nicotine tartrate. Substituted nicotine may be 6-methylnicotine. Substituted nicotine salts may be 6-methylnicotine salts, such as 6-methylnicotine benzoate. In some embodiments, the active agent may be present as crystalline particles formed from nicotine and / or nicotine derivatives.

[0061] In some embodiments, the active agent may also be a substance with medical properties or other specific active properties, such as vitamins, caffeine, tea polyphenols, theophylline, etc.

[0062] In some embodiments, the printed layer 12 and / or functional layer 113 further include a solvent, wherein the solvent includes at least one of drinking water, glycerin, propylene glycol, polyethylene glycol, sorbitol, maltitol, edible ethanol, polyglycerol fatty acid ester, polysorbate 80, honey, plant extracts and fruit juice.

[0063] In some embodiments, the printed layer 12 is adhered to the outer surface of the substrate 11. In some embodiments, an edible adhesive can be sprayed onto the side of the printed layer 12 where the printed marking is not prepared, and the printed layer 12 can be adhered to the outer surface of the substrate 11 using the edible adhesive. The printed marking in the printed layer 12 can be prepared before being laminated with the substrate 11, thereby avoiding the pressure on the substrate 11 during the preparation of the printed marking. This helps to further reduce the degree of deformation of the functional layer 113 in the substrate 11 and the deviation in the content of the active agent caused by the deformation of the functional layer 113, thereby improving the uniformity of the distribution of the active agent in the oral product 10 and the consistency of the taste of the oral product 10 during oral use. The edible adhesive may include, but is not limited to, sodium alginate, carrageenan, xanthan gum, guar gum, gum arabic, pectin, cold-cured gum, gelatin, shellac, dammar resin, etc.

[0064] In some embodiments, the relative deviation of the active agent content in functional layer 113 is less than or equal to 5%. By controlling the relative deviation of the active agent content in functional layer 113 to be less than or equal to 5%, the uniformity of the active agent distribution in the oral product 10 and the consistency of the mouthfeel during oral administration can be further improved, promoting the effective exertion of the active agent's therapeutic effect. The relative deviation of the active agent content in functional layer 113 refers to the relative standard deviation (RSD) between the active agent contents at different locations in functional layer 113, expressed as a percentage (%). The active agent content in functional layer 113 refers to the mass fraction of the active agent in functional layer 113.

[0065] In some embodiments, the water content of the oral product 10 is less than or equal to 10%, which not only helps to improve the mechanical strength of the oral product 10, reduce the breakage rate of the oral product 10 during cutting, packaging and transportation, and improve the appearance quality of the oral product 10, but also improves the stability of each component in the oral product 10, inhibits the growth of microorganisms in the oral product 10, and extends the shelf life of the oral product 10.

[0066] In some embodiments, the water content of the oral article 10 refers to the total content of solvents in the oral article 10.

[0067] In some embodiments, refer to Figure 4The functional layer 113 includes at least two sub-functional layers 1131. Through the layered structural design, the surfactant can be carried in separate zones. Furthermore, the at least two sub-functional layers 1131 can work synergistically with the first support layer 111 and the second support layer 112 to enhance the overall structural strength of the oral product 10, effectively buffer against external forces during the printing process, reduce the probability of deformation of the functional layer 113, and further improve the uniformity of surfactant distribution and the stability of surfactant release in the oral product 10, providing users with a more stable oral experience. It should be noted that the thickness, composition, and content of each component in the different sub-functional layers 1131 within the functional layer 113 can be the same or different.

[0068] In some embodiments, refer to Figure 5 A waterproof layer 13 is also provided between adjacent sub-functional layers 1131. The waterproof layer 13 is waterproof and can prevent the penetration of liquids such as saliva. Figure 5 In the oral product 10 shown, the waterproof layer 13 separates the two adjacent sub-functional layers 1131, which can reduce the mutual reaction of the two adjacent sub-functional layers 1131 under the dissolving action of saliva, prevent the structure of the oral product 10 from collapsing, and help improve the structural stability of the oral product 10.

[0069] The waterproof layer 13 can also support the sub-functional layers 1131 set on both sides thereon, reduce the probability of deformation of the sub-functional layers 1131, improve the structural stability of the functional layer 113, and further improve the uniformity of the distribution of the active agent in the oral product 10 and the consistency of the taste of the oral product 10 during the oral process.

[0070] In some embodiments, the waterproof layer 13 is a water-repellent fabric or a release film.

[0071] In some embodiments, the thickness of the waterproof layer 13 is 0.15 mm to 0.25 mm. Within this range, the waterproof layer 13 can not only be given a certain mechanical strength to support the sub-functional layer 1131, but also ensure that the waterproof layer 13 has a certain degree of flexibility, thereby improving the overall flexibility and oral comfort of the oral article 10. In some embodiments, the thickness of the waterproof layer 13 can be one of 0.15 mm, 0.18 mm, 0.2 mm, 0.23 mm, and 0.25 mm, or any value between two of them.

[0072] In some embodiments, the thickness of the functional layer 113 is 0.15 mm to 0.3 mm. Within this range, the content of the active agent in the functional layer 113 can be increased and the release time of the active agent in the functional layer 113 can be prolonged, while ensuring that the overall size of the oral article 10 meets the design requirements. In some embodiments, the thickness of the functional layer 113 can be one of 0.15 mm, 0.20 mm, 0.23 mm, 0.27 mm, and 0.3 mm, or any value between two of them.

[0073] In some embodiments, the thickness of the first support layer 111 is 0.1 mm to 0.12 mm. Within this range, it is beneficial to fully utilize the role of the first support layer 111 in providing mechanical support for the oral article 10, reducing the degree of deformation of the functional layer 113, and reducing the deviation in the content of the active agent caused by the deformation of the functional layer 113.

[0074] In some embodiments, the thickness of the second support layer 112 is 0.1 mm to 0.12 mm. Within this range, it is beneficial to fully utilize the role of the second support layer 112 in providing mechanical support for the oral article 10, reducing the degree of deformation of the functional layer 113, and reducing the deviation in the content of the active agent caused by the deformation of the functional layer 113.

[0075] In some embodiments, the thickness of the sub-functional layer 1131 is 0.15mm to 0.3mm. Within this range, it is beneficial for the sub-functional layers 1131 to adhere smoothly to each other, improve the overall structural stability and molding effect of the oral article 10, and promote the joint improvement of the oral article 10 in terms of active agent release efficiency, mechanical strength and oral taste.

[0076] In some embodiments, the functional layer 113 further includes a film-forming substrate. The film-forming substrate serves as the film-forming framework of the functional layer 113, and is used to construct a stable film structure through intermolecular hydrogen bonds, van der Waals forces, or cross-linking, uniformly disperse the active agent and other components in the functional layer 113, promote the film formation of the functional layer 113, and improve the structural stability of the functional layer 113 during storage and oral administration.

[0077] In some embodiments, the film-forming substrate includes at least one of polysaccharide polymers, colloids, cellulose derivatives, and polyolefin polymers. The polysaccharide polymers may include at least one of gum arabic, xanthan gum, carrageenan, sodium alginate, pectin, chitosan, starch, starch derivatives, and pullulan; the cellulose derivatives may include at least one of methylcellulose, hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), sodium carboxymethyl cellulose, carboxyethyl cellulose (CEC), and hydroxypropyl methylcellulose; the polyolefin polymers may include at least one of polyvinyl alcohol (PVA), polyvinylpyrrolidone, polyethylene glycol, povidone-iodine, polyethylene oxide (PEO), and food-grade polyacrylic acid resin (PAR).

[0078] In some embodiments, the functional layer 113 further includes at least one of a filler, an antioxidant, a flavoring agent, a plasticizer, and a pH adjuster.

[0079] The filler is used to fill the gaps between molecules in the film-forming substrate, improve the density and uniformity of the functional layer 113 film, reduce defects such as uneven film thickness and pores caused by insufficient viscosity of the film-forming substrate or loose molecular chains, and improve the mechanical strength and flexibility of the functional layer 113.

[0080] In some embodiments, the filler may include at least one of mannitol, xylitol, maltitol, sorbitol, glucose, sucrose, lactose, microcrystalline cellulose, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose (EC), dicalcium phosphate (CaHPO4), calcium carbonate (CaCO3), and silicon dioxide (SiO2).

[0081] Antioxidants can reduce the probability of oxidation of the active agent in the functional layer 113 and extend the shelf life of the oral product 10.

[0082] In some embodiments, the antioxidant includes at least one selected from pine bark extract, rosemary extract, grape seed extract, resveratrol, coenzyme, anthocyanin, quercetin, protocatechuic acid (PCA), tocopherol, apple polyphenols, ascorbic acid (AA), tea polyphenols (TP), astaxanthin, propyl gallate (PG), butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tert-butylhydroquinone (TBHQ), ethylparaben, and sodium erythrothorbate (SE).

[0083] Flavoring agents are used to mask the unpleasant taste of surfactants, such as bitterness and astringency, neutralize the irritation of surfactants, and alleviate the irritation of surfactants to the oral mucosa.

[0084] In some embodiments, the flavoring agent includes at least one of a sweetener, a cooling agent, a savory agent, and a flavoring.

[0085] The sweetener is used to mask the bitterness, astringency, and irritation of the active agent through a sweet taste signal, while constructing the basic flavor of the oral product 10. The sweetener may include at least one of sucralose, neotame, aspartame, acesulfame potassium, steviol glycosides, xylitol, iodine, mannitol, sorbitol, erythritol, maltitol, lactitol, sodium saccharin, mongosaccharin, sucram, agave, maple syrup, fructose, alitane, cyclamate, mogroside, advanyl acetate, and ammonium glycyrrhizate.

[0086] Cooling agents are used to produce a cooling sensation by stimulating oral cold receptors, thereby enhancing oral pleasure of the oral product 10 and masking the irritation of the active agent; the cooling agents may include at least one of N-ethyl-(2-isopropyl-5-methyl)cyclohexaneamide (WS-3), N,2,3-trimethyl-2-(1-methylethyl)butanamide (WS-23), N-(ethoxycarbonylmethyl)-p-menthane-3-carboxamide (WS-5), N-ethyl-2,2-diisopropylbutanamide (WS-27), N-(4-methoxyphenyl)-p-menthyl-3-carboxamide (WS-12), menthol, and isomenthol.

[0087] Salting agents are used to improve the smoothness of sweeteners, reduce the cloying sweetness of sweeteners, and enhance the harmony of complex flavors. At the same time, salting agents can also inhibit the perception of bitterness and metallic taste by taste receptors, thereby improving the mouthfeel of oral product 10. Salting agents may include at least one of sodium chloride (NaCl), potassium chloride (KCl), potassium dihydrogen phosphate (KH2PO4), and dipotassium hydrogen phosphate (K2HPO4).

[0088] Flavorings are flavoring additives composed of a variety of aromatic substances, which can impart a specific flavor to functional layer 113 and mask the odor of active agents. Flavorings are edible flavorings and can be of any flavor; this application does not specifically limit this. In some embodiments, flavorings include naturally extracted flavorings, synthetic flavorings, and compound flavorings; wherein, naturally extracted flavorings may include, but are not limited to, peppermint oil, lemon oil, linalool, licorice extract, tea polyphenols, clove oil, etc.; synthetic flavorings may include, but are not limited to, ethyl acetate, vanillin, menthol, geraniol, coumarin, etc.; compound flavorings may include flavorings obtained by secondary blending of various flavorings.

[0089] The pH adjuster is used to maintain the pH value of the functional layer 113 in a weakly alkaline state. This not only neutralizes the irritation of the acidic components in the functional layer 113 and reduces the burning sensation of the acidic components in the oral cavity, but also ensures that the active agents such as nicotine are in a non-ionic state in the alkaline environment, which is not easily degraded and is more easily absorbed by the oral mucosa. This is beneficial to improving the bioavailability of the oral product 10 and extending the shelf life of the oral product 10.

[0090] In this application, the pH detection value refers to the value obtained by mixing the functional layer 113 with water or other suitable solvent and then detecting it using a pH electrode, pH test paper, or acid-base titration solution. For example, the pH detection value of the functional layer 113 can be measured according to the test method in the national standard GB / T12456-2008, "Determination of Total Acidity in Food".

[0091] In some embodiments, the pH adjuster includes at least one selected from citric acid (CA), sodium citrate (Na3C6H5O7), sodium tartrate (Na2C4H4O6), sodium dihydrogen phosphate (NaH2PO4), disodium hydrogen phosphate (Na2HPO4), sodium lactate (C3H5NaO3), sodium bicarbonate (NaHCO3), and sodium carbonate (Na2CO3).

[0092] Plasticizers can penetrate into the molecular chains of the film-forming substrate, destroying or weakening intermolecular hydrogen bonds, van der Waals forces, and other forces, reducing the molecular chain aggregation density, improving the flexibility of the functional layer 113, and thus improving the overall flexibility of the oral product 10 and the oral comfort of the oral product 10.

[0093] In some embodiments, the plasticizer may include at least one of glycerin, sodium hyaluronate, and propylene glycol.

[0094] In some embodiments, the functional layer 113 comprises, by mass parts, 16 to 45 parts film-forming substrate, 1 to 5 parts activator, 4 to 15 parts filler, 0.2 to 0.5 parts antioxidant, 2 to 13 parts flavoring agent, 5 to 25 parts plasticizer, 1 to 2 parts pH adjuster, and 30 to 45 parts solvent.

[0095] This application provides a method for preparing a mouth-held product, such as... Figure 6 As shown, the preparation method includes the following steps: Step S101: Obtain a substrate, which includes a first support layer, a second support layer and a functional layer. The functional layer is located between the first support layer and the second support layer. At least one of the first support layer and the second support layer is a water-permeable layer. The functional layer includes an active agent.

[0096] Step S102: Obtain the printing layer paste, which includes starch and / or starch derivatives.

[0097] Step S103: Using printing paste, a printing layer is formed on the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer to obtain an oral article, wherein the printing layer includes a printed mark and the printing layer is orally repellent.

[0098] The method for preparing the oral article provided in this application can realize the preparation of the oral article as described in any of the above embodiments. The oral article includes a substrate and a printed layer. The substrate includes a first support layer, a second support layer and a functional layer. The functional layer is located between the first support layer and the second support layer. At least one of the first support layer and the second support layer is a water-permeable layer. The functional layer includes an active agent. The printed layer is formed on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer. The printed layer includes a printed mark. The printed layer includes starch and / or starch derivatives. The printed layer is orally dissipable.

[0099] In step S101, firstly, the components used to prepare the functional layer are added to a solvent and mechanically stirred at 500 rpm to 1000 rpm for 30 to 45 minutes to form a uniform viscous liquid. After standing to remove bubbles, a functional layer slurry is obtained. Then, the functional layer slurry is uniformly coated to form a functional coating layer. Next, the functional coating layer is pre-dried at 40°C to 60°C for 5 to 10 minutes. Afterward, the pre-dried functional coating layer is placed in a drying oven (e.g., a tunnel oven) and dried at a preset temperature and wind speed for 15 minutes to remove most of the solvent, thus obtaining the functional layer. Finally, the first support layer and the second support layer are applied to the opposite sides of the functional layer and rolled at 0.5 kg / cm². 2 ~2kg / cm 2 Under pressure, the first support layer, the second support layer, and the functional layer are initially bonded together. After bonding, drying continues for 10 minutes to obtain the substrate. It should be noted that the specific production process parameters can be adjusted according to the specific production equipment and conditions, and this application does not impose specific limitations.

[0100] In some embodiments, the functional layer includes at least two sub-functional layers, and a waterproof layer is provided between adjacent sub-functional layers. In step S101, firstly, a functional layer slurry is obtained; then, the functional layer slurry is uniformly coated on both sides of the waterproof layer to obtain a coating layer of adjacent sub-functional layers; then, the coating layer of the sub-functional layers is pre-dried; then, the pre-dried coating layer of the sub-functional layers is sent to a drying oven and dried for 15 minutes at a preset temperature and wind speed to remove most of the solvent in the coating layer of the sub-functional layers, resulting in sub-functional layers disposed on both sides of the waterproof layer; finally, a first support layer is covered on the outer surface of the sub-functional layer located on one side of the waterproof layer away from the outer surface of the waterproof layer, and a second support layer is covered on the outer surface of the sub-functional layer located on the other side of the waterproof layer away from the outer surface of the waterproof layer, and the layers are rolled at 0.5 kg / cm². 2 ~2kg / cm 2 Under pressure, the first support layer, the second support layer, and the sub-functional layer are initially bonded together. After bonding, drying continues for 10 minutes to obtain the substrate. It should be noted that the specific production process parameters can be adjusted according to the specific production equipment and conditions, and this application does not impose specific limitations.

[0101] In some embodiments, the thickness of the coating layer of the functional coating layer and / or sub-functional layer is 0.2 mm to 0.5 mm; the preset temperature is 70°C to 90°C.

[0102] In some embodiments, the ambient humidity during the preparation of the functional layer is less than or equal to 40% to prevent the functional layer from absorbing moisture.

[0103] In some embodiments, the components used to prepare the functional layer, measured by mass parts, include 16 to 45 parts of film-forming substrate, 1 to 5 parts of activator, 4 to 15 parts of filler, 0.2 to 0.5 parts of antioxidant, 2 to 13 parts of flavoring agent, 5 to 25 parts of plasticizer, and 1 to 2 parts of pH adjuster.

[0104] In step S102, the component materials used to prepare the printing layer can be added to a solvent to prepare the printing layer paste. The component materials used to prepare the printing layer include starch and / or starch derivatives.

[0105] In some embodiments, the component materials used to prepare the printing layer further include at least one of colloid, plasticizer, stabilizer, disintegrant, and food coloring; in some embodiments, the component materials used to prepare the printing layer, measured by mass parts, include 45 to 75 parts of starch and / or starch derivatives, 5 to 22 parts of colloid, 8 to 15 parts of plasticizer, 0.1 to 2 parts of stabilizer, 0.1 to 0.2 parts of disintegrant, and 0.5 to 2 parts of food coloring.

[0106] In step S103, the printing paste is first formed into a film to obtain an initial film layer. Then, the printing mold is used to press the printing mark on the outer surface of the initial film layer away from the first support layer and / or away from the outer surface of the second support layer. After drying, the printing layer is formed.

[0107] In some embodiments, after obtaining the oral article through step S103, the entire oral article can be cut into standard sizes (e.g., 10mm × 10mm) using a die-cutting device, and the oral articles with standard sizes can be packed into packaging bags and sealed to improve the stability of the oral article during storage and transportation.

[0108] The method for preparing oral products provided in this application utilizes a printing layer paste to form a printing layer on the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer in the substrate, thereby obtaining an oral product. This method can improve the clarity and durability of the printed markings while reducing the pressure transmitted to the functional layer in the substrate during the printing marking preparation process. This reduces the degree of deformation of the functional layer and the deviation in the content of the surfactant caused by the deformation of the functional layer, thereby improving the uniformity of the surfactant distribution in the oral product and the consistency of the taste during the oral product's use.

[0109] In some embodiments, the printing layer further includes a colloid and / or a stabilizer. Step S102, obtaining the printing layer paste, includes: Step S1021: Dissolve or swell the colloid and / or stabilizer to prepare a first dispersion.

[0110] Step S1022: Mix starch and / or starch derivatives with the first dispersion to prepare the printing layer paste.

[0111] In the embodiments of this application, in scenarios where the printing layer also includes colloids and / or stabilizers, during the preparation of the printing layer paste, the colloids and stabilizers can first be dissolved or swollen in step S1021 to uniformly disperse the colloid molecules and stabilizer molecules to form a stable first dispersion. Then, in step S1022, starch and starch derivatives are mixed with the first dispersion to prepare the printing layer paste. This helps to promote the uniform dispersion of starch and starch derivatives in the first dispersion, reduce the probability of starch and starch derivatives clumping, improve the uniformity and stability of the printing layer paste system, and thus improve the film quality of the printing layer prepared using the printing layer paste.

[0112] In scenarios where the printing layer also includes other component materials besides colloids, stabilizers, starch, and starch derivatives, in step S1022, starch, starch derivatives, and other component materials can be mixed with the first dispersion to prepare the printing layer paste. In some embodiments, the other component materials include at least one of plasticizers, disintegrants, and food colorings.

[0113] In step S1021, the colloid and stabilizer can be dissolved in a solvent, allowed to stand and swell, to obtain the first dispersion.

[0114] In step S1022, starch, starch derivatives and other component materials can be first dispersed evenly in an appropriate amount of solvent to form a second dispersion. Then, the second dispersion is mixed with the first dispersion, stirred evenly and degassed to obtain the printing layer paste.

[0115] In some embodiments, an initial film layer can be prepared on the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer in the substrate using a printing layer paste. Then, a printing mold is used to press a printed mark onto the outer surface of the initial film layer away from the first support layer and / or the outer surface of the second support layer. After drying, a printed layer formed on the outer surface of the substrate is obtained, thereby obtaining the oral article provided in this application. In some embodiments, step S103, which uses a printing layer paste to form a printed layer on the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer, includes: Step S1031: Apply the printing paste to the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer to form a coating layer.

[0116] Step S1032: Perform a first curing treatment on the coating layer to obtain a first cured layer.

[0117] Step S1033: Perform a first embossing process on the outer surface of the first cured layer to prepare a printed mark on the outer surface of the first cured layer, so as to obtain the first printed cured layer.

[0118] Step S1034: Perform a second curing treatment on the first printed curing layer to obtain the printed layer.

[0119] In this embodiment, the printing paste can be directly applied to the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer in the substrate to form a coating layer. A printing mold is then used to prepare a printing mark on the outer surface of the first cured layer formed by the first curing treatment of the coating layer to obtain the first printed cured layer. Finally, the first printed cured layer is subjected to a second curing treatment to obtain the printing layer in the oral product. This not only simplifies the preparation process of the oral product, but also allows the first cured layer to bear the pressure exerted on the oral product by the first imprinting process during the printing mark preparation process, reducing the pressure transmitted to the substrate by the first imprinting process, reducing the degree of deformation of the functional layer and the deviation in the content of the surfactant caused by the deformation of the functional layer, improving the uniformity of the surfactant distribution in the oral product and the consistency of the taste of the oral product during the oral process.

[0120] In step S1031, the printing layer paste can be applied to the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer in the substrate using a roller coating device to form a coating layer.

[0121] In some embodiments, the thickness of the coating layer is 0.1 mm to 0.3 mm. Within this range, the printing paste can uniformly cover the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer, better adapting to the first imprinting process and improving the accuracy and clarity of the printed mark prepared on the outer surface of the first cured layer.

[0122] In step S1032, the coating layer is subjected to a first curing treatment, which can solidify and shape the coating layer, giving the first cured layer a certain mechanical strength and rigidity. This prevents the first cured layer from collapsing and deforming during the first imprinting process in step S1033, while improving the clarity of the printed marking texture prepared on the outer surface of the first cured layer.

[0123] In some embodiments, the temperature of the first curing treatment is 50°C to 70°C, and the duration of the first curing treatment is 10 min to 15 min. Within this range, about 80% of the solvent in the coating layer can be removed, so that the components in the printing layer paste form a stable structure with preliminary cross-linking, thereby improving the mechanical strength, flexibility and printing mark transfer rate of the first cured layer, and thus improving the printing efficiency and printing quality of the first imprinting treatment performed on the outer surface of the first cured layer in step S1033.

[0124] In step S1033, a printing mold can be used to perform a first imprinting process on the outer surface of the first cured layer, thereby forming a printed mark on the outer surface of the first cured layer, thus obtaining a first printed cured layer. The outer surface of the first cured layer includes the outer surface of the first cured layer that faces away from the first support layer, and / or, the outer surface of the first cured layer that faces away from the second support layer.

[0125] In some embodiments, the pressure of the first imprinting process is 0.5MPa~2MPa, the temperature of the first imprinting process is 40℃~60℃, and the duration of the first imprinting process is 1s~5s. Within this range, the first imprinting process is a cold imprinting process, which can ensure that the printing mold and the outer surface of the first cured layer are fully adhered, forming a clear and complete printed mark on the outer surface of the first cured layer, improving the clarity of the printed mark prepared on the outer surface of the first cured layer. It can also reduce the pressure transmitted to the substrate by the first imprinting process, reduce the degree of deformation of the functional layer and the deviation of the surfactant content caused by the deformation of the functional layer, improve the uniformity of surfactant distribution in the oral product and the consistency of taste of the oral product during the oral process.

[0126] In step S1034, by performing a second curing treatment on the first printing curing layer, most of the solvent in the first curing layer can be removed, promoting the formation of a tightly cross-linked network structure of the components in the printing layer paste, further improving the mechanical strength and flexibility of the printing layer formed by the second curing treatment of the first printing curing layer, and shaping the printed markings in the printing layer, reducing the deformation and damage of the printed markings during subsequent processing, transportation and storage, and improving the recognizability and stability of the printed markings in oral products.

[0127] In some embodiments, the second curing process includes ultraviolet curing or natural drying; wherein the duration of ultraviolet curing is 10s to 30s, and the ultraviolet wavelength is 365nm.

[0128] In some embodiments, a printing layer can be formed on any smooth plane using a printing layer paste, and then the printing layer is laminated with the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer in the substrate to obtain the oral article provided in this application. In some embodiments, step S103, which uses a printing layer paste to form a printing layer on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer, includes: Step S1035: Cast the printing layer paste into a film to obtain a cast film.

[0129] Step S1036: Perform a third curing treatment on the cast film to obtain a second cured layer.

[0130] Step S1037: Perform a second embossing process on either side of the second cured layer to prepare a printed mark on the second cured layer, thereby obtaining the second printed cured layer.

[0131] Step S1038: The second printing curing layer is laminated with the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer, and a fourth curing treatment is performed to form a printing layer on the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer.

[0132] In this embodiment, the second printing curing layer is first obtained through steps S1035 to S1037, which avoids the pressure on the substrate during the preparation of the printed mark. Then, in step S1038, the second printing curing layer is composited with the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer in the substrate, and a fourth curing treatment is performed to obtain the printed layer in the oral product. This embodiment improves the recognizability of the oral product by printing the mark in the printed layer, while further reducing the degree of deformation of the functional layer in the substrate and the deviation of the surfactant content caused by the deformation of the functional layer, thereby improving the uniformity of surfactant distribution in the oral product and the consistency of taste during the oral product.

[0133] In step S1035, the printing paste can be cast onto a smooth surface to form a film, thereby obtaining a cast film. In some embodiments, the smooth surface includes the surface of a mirror-finished steel strip.

[0134] In some embodiments, the thickness of the cast film is 0.1 mm to 0.3 mm. Within this range, the uniformity of the cast film can be improved, better adapting to the second imprinting process, and improving the accuracy and clarity of the printed markings prepared on the outer surface of the second cured layer.

[0135] In step S1036, the cast film undergoes a third curing treatment, and the second cured layer is obtained by peeling off the film. By performing a third curing treatment on the cast film, the cast film can be cured and shaped, giving the second cured layer a certain mechanical strength and rigidity. This prevents the second cured layer from collapsing and deforming during the second imprinting process in step S1037, while improving the clarity of the printed marking texture prepared on the outer surface of the second cured layer.

[0136] In some embodiments, the temperature of the third curing process is 60°C to 80°C. Within this temperature range, about 80% of the solvent in the cast film can be removed, allowing the components in the printing layer paste to form a stable structure with preliminary cross-linking, thereby improving the mechanical strength, flexibility, and printing mark transfer rate of the second cured layer, and thus improving the printing efficiency and printing quality of the second imprinting process performed on the outer surface of the second cured layer in step S1037.

[0137] In step S1037, a second embossing process can be performed on either side of the second cured layer using a printing mold, thereby preparing a printed mark on either side of the second cured layer to obtain a second printed cured layer.

[0138] In some embodiments, the pressure of the second imprinting process is 0.5 MPa to 1.5 MPa, and the temperature of the second imprinting process is room temperature (20°C to 30°C). Within this range, the second imprinting process is a cold imprinting process, and the surface viscosity of the second cured layer is low. During the imprinting process, it is not easy to form jagged and blurred edges at the printed mark, which is beneficial to improve the imprinting accuracy of the lines in the printed mark, thereby improving the clarity of the printed mark prepared on the surface of the second cured layer. Furthermore, the second imprinting process only imprints the second cured layer and does not exert pressure on the substrate, which is beneficial to further reduce the degree of deformation of the functional layer in the substrate and the deviation of the surfactant content caused by the deformation of the functional layer, thereby improving the uniformity of surfactant distribution in the oral product and the consistency of the taste of the oral product during the oral process.

[0139] In step S1038, an edible adhesive can be sprayed onto the side of the second printed curing layer where the printed mark is not prepared using an optical alignment system. Then, the side of the second printed curing layer where the printed mark is not prepared is combined with the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer, and a fourth curing treatment is performed. This allows the edible adhesive between the second curing layer and the substrate, as well as the components in the second curing layer and the substrate, to form a dense cross-linked network structure. This forms a printed layer on the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer, resulting in a mouth-held product. This process helps improve the bonding strength between the printed layer and the substrate in the mouth-held product, as well as the overall mechanical strength of the mouth-held product. In addition, the fourth curing treatment can also shape the printed mark in the printed layer, reducing the deformation and damage of the printed mark during subsequent processing, transportation, and storage, and improving the recognizability and stability of the printed mark in the mouth-held product.

[0140] Edible adhesives may include, but are not limited to, sodium alginate, carrageenan, xanthan gum, guar gum, gum arabic, pectin, cold-setting gum, gelatin, shellac, dammar resin, etc.

[0141] In some embodiments, the pressure at which the second printing curing layer is bonded to the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer is 0.1 MPa to 0.3 MPa. In this embodiment, the second printing curing layer can be bonded to the substrate with a smaller pressure, which can reduce the degree of deformation of the functional layer in the substrate and the deviation of the surfactant content caused by the deformation of the functional layer.

[0142] In some embodiments, the fourth curing process includes ultraviolet curing or natural drying; wherein the duration of ultraviolet curing is 10s to 30s, and the ultraviolet wavelength is 365nm.

[0143] The present application will be further described in detail below through specific embodiments and comparative examples, so as to obtain oral products by the above-described method for preparing oral products.

[0144] The following embodiments are only some embodiments of this application and are not intended to limit this application. In the embodiments and comparative examples, unless otherwise specified, the reagents and instruments used are all commercially available, and the experimental operations are all performed in accordance with the product instructions and conventional experimental procedures.

[0145] Example 1 (1) Preparation of the matrix: First, the components used to prepare the functional layer are added to a solvent and mechanically stirred at 800 rpm for 40 minutes to form a uniform viscous liquid. After standing to remove bubbles, a functional layer slurry is obtained. Then, the functional layer slurry is evenly coated onto both sides of the water-repellent fabric to obtain the coating layer of the sub-functional layer. Next, the coating layer of the sub-functional layer is pre-dried at 50°C for 8 minutes. Afterward, the pre-dried coating layer of the sub-functional layer is placed in a tunnel oven and dried at 80°C for 15 minutes to obtain the sub-functional layer. Finally, non-woven fabric is placed over the outer surface of each sub-functional layer facing away from the water-repellent fabric and pressed using a roller press at 1.2 kg / cm². 2 The nonwoven fabric and the sub-functional layer are initially bonded under pressure, and then dried for 10 minutes to obtain the substrate. The thickness of the coating layer of the sub-functional layer is 0.3 mm. The components of the functional layer slurry are shown in Table 1.

[0146] Table 1

[0147] (2) Preparation of printing layer paste: First, the colloid and stabilizer are dissolved in a solvent and allowed to swell to obtain a first dispersion. Then, the starch and plasticizer are dispersed evenly in an appropriate amount of solvent to form a second dispersion. Finally, the second dispersion is mixed with the first dispersion, stirred evenly, and degassed to obtain the printing layer paste. The components of the printing layer paste are shown in Table 2.

[0148] Table 2

[0149] (3) Preparation of the printing layer: First, the printing paste prepared in step (2) is coated onto the outer surface of the nonwoven back ion functional layer in the substrate using a roller coating equipment to form a coating layer with a thickness of 0.2 mm. Then, the coating layer is subjected to a first curing treatment to obtain a first cured layer. The temperature of the first curing treatment is 60°C and the duration of the first curing treatment is 13 min. After that, a printing mold with an "M" shaped printing mark is used to perform a first imprinting treatment on the outer surface of the first cured layer to prepare the printing mark on the outer surface of the first cured layer, thereby obtaining the first printed cured layer. The pressure of the first imprinting treatment is 1.5 MPa, the temperature of the first imprinting treatment is 50°C, and the duration of the first imprinting treatment is 2 s.

[0150] (4) Preparation of oral products: The first printed curing layer is subjected to a second curing treatment to obtain a printed layer, thereby obtaining a mouthpiece including the printed layer; wherein, the printed layer is a glutinous rice paper layer, the second curing treatment is ultraviolet curing, the ultraviolet curing time is 20s, the ultraviolet wavelength is 365nm, in the mouthpiece, the thickness of the printed layer is 0.1mm, the thickness of the water-repellent cloth is 0.2mm, the thickness of the sub-functional layer is 0.2mm, and the thickness of the non-woven fabric is 0.11mm.

[0151] Examples 2-3 The difference between Examples 2 and 3 and Example 1 is as follows: In step (2), the types and contents of each component material in the printing layer paste are adjusted. The components of the printing layer paste prepared by Example 2 are shown in Table 3, and the components of the printing layer paste prepared by Example 3 are shown in Table 4.

[0152] Table 3

[0153] Table 4

[0154] Example 4 The difference between Example 4 and Example 1 is as follows: In step (3), firstly, the printing paste is cast onto a smooth mirror steel strip to form a film, and the thickness of the cast film is 0.2 mm; then, the cast film is subjected to a third curing treatment to obtain a second cured layer, and the temperature of the third curing treatment is 70°C; then, a printing mold with an "M" shaped printing mark is used to perform a second imprinting treatment on either side of the second cured layer to prepare a printing mark on one side of the second cured layer to obtain a second printed cured layer; wherein, the pressure of the second imprinting treatment is 1 MPa and the temperature of the second imprinting treatment is 25°C.

[0155] In step (4), sodium alginate solution is sprayed onto the side of the second printing curing layer where the printed mark is not prepared using an optical alignment system. Then, the side of the second printing curing layer where the printed mark is not prepared is combined with the outer surface of the nonwoven back ion functional layer in the substrate under a pressure of 0.2 MPa, and a fourth curing treatment is performed to obtain a printed layer formed on the outer surface of the nonwoven back ion functional layer, thereby obtaining a mouth-held product including the printed layer. The fourth curing treatment is ultraviolet curing, the ultraviolet curing time is 20s, and the ultraviolet wavelength is 365nm.

[0156] Comparative Example 1 The difference between Comparative Example 1 and Example 1 is as follows: Step (2) is excluded; In step (3), a printing mold with an "M" shaped printing mark is used to perform a third embossing treatment on the outer surface of the nonwoven back ion functional layer in the substrate to prepare the printing mark on the outer surface of the substrate. The pressure of the third embossing treatment is 3MPa, the temperature of the third embossing treatment is 80℃, and the duration of the third embossing treatment is 5s. In step (4), the substrate with printed markings on its outer surface is subjected to a second curing treatment to obtain a mouth-held product.

[0157] Test method: (1) Clarity test of printed logo: The surface of the oral product, including the printed logo, was scanned under standard lighting conditions using a high-resolution flatbed scanner (1200 dpi). Image analysis software (e.g., ImageJ) was used to quantitatively analyze the edge sharpness and contrast of the printed logo (taking "M" as an example) and to perform visual scoring. Edge sharpness was determined by measuring the distance (in pixels) from 10% to 90% of the grayscale value at the edge of the printed logo; a smaller distance indicates a sharper edge and higher edge sharpness. Contrast was determined by calculating the difference in average grayscale values ​​between the logo area and the background area; a larger difference in average grayscale values ​​indicates higher contrast and clearer logo. The visual scoring was conducted by three trained evaluators who independently scored the integrity, edge burrs, and overall clarity of the printed logo under a standard observation lightbox, comparing it to a standard clarity card (1-5 points, with 5 being the best).

[0158] (2) Dissolution and corrosion performance test: Disintegration time: Referring to the pharmacopoeia disintegration time limit method, the oral product was placed in artificial saliva (pH=6.8) at 37°C, and the time for complete disintegration or perforation of the oral product was recorded.

[0159] Solubility: Accurately weigh the oral product (W0), then fix the oral product on the stirring paddle, stir at a low speed of 50 rpm in artificial saliva at 37°C, remove after 30 seconds, blot dry the surface moisture, and weigh (W0). t ), calculate the dissolution rate = (W0 - W t ) / W0×100%.

[0160] (3) Physicochemical tests: Active agent content test: The active agent content in the oral products was determined according to the High Performance Liquid Chromatography (HPLC) method in the Chinese Pharmacopoeia. Ten tablets of the oral products prepared in each example and comparative example were randomly selected, crushed, dissolved, and diluted to a certain volume before being injected for analysis to determine the active agent content in the oral products.

[0161] pH test: Dissolve one lozenge in 100mL of purified water and stir until completely dissolved. Measure the pH value of the solution using a precision pH meter. This pH value is used as the pH test value of the lozenge.

[0162] Moisture content test: Place a piece of oral medication into a calibrated Karl Fischer instrument and titrate to determine the moisture content value.

[0163] (4) Softness test: The softness of oral products is measured using a texture analyzer. The smaller the bending force output by the texture analyzer, the softer the oral product.

[0164] (5) Tasting test: Three trained evaluators conducted a double-blind tasting test on the oral products prepared through the examples and comparative examples, and scored the oral products on three aspects: smoothness of mouthfeel, overall acceptability, and preference for printed labels.

[0165] Test results: (1) The clarity of printed markings was tested on the oral products prepared by Example 1, Example 4 and Comparative Example 1. The test results are shown in Table 5.

[0166] Table 5

[0167] As can be seen from the test results in Table 5, the clarity of the printed markings in the oral products prepared by Examples 1 and 4 is significantly better than that of Comparative Example 1. The edge sharpness of the printed markings in Example 1 is 5.2 pixels and the contrast is 185 grayscale value. The edge sharpness of the printed markings in Example 4 is 3.9 pixels and the contrast is 210 grayscale value. Compared with Comparative Example 1, the edge sharpness is improved by more than 67% and the contrast is improved by more than 100%. Furthermore, the visual score of the printed markings in the oral products prepared by Examples 1 and 4 is close to full marks. This fully demonstrates the effectiveness of the cold pressing process in preparing printed markings in this application in achieving high-definition and accurate printing, effectively improving the clarity of the printed markings in oral products, and thus improving the recognizability and appearance quality of oral products.

[0168] (2) The solubility and corrosion performance of the oral products prepared by Examples 1-4 and Comparative Example 1 were tested, and the test results are shown in Table 6.

[0169] Table 6

[0170] As can be seen from the test results in Table 6, adding a disintegrant to the printed layer helps to increase the disintegration and dissolution rate of the printed layer on the outer surface of the oral product. This allows the printed layer in Example 2 to disintegrate rapidly in about 18 seconds and achieve a dissolution rate of about 75% within 30 seconds. This helps to accelerate the dissipation of the printed layer during oral use, promotes the release of the active agent in the matrix, avoids the sticky feeling of the printed layer during oral use, and improves the oral taste of the oral product.

[0171] (3) Physicochemical tests were conducted on the oral products prepared by Examples 1-4 and Comparative Example 1. The test results are shown in Table 7.

[0172] Table 7

[0173] As can be seen from the test results in Table 7, the content of active agent, pH value and water content in the oral products prepared by the embodiments of this application were not affected, indicating that the process of the embodiments of this application has good stability.

[0174] (4) The softness of the oral products prepared by Example 1 and Comparative Example 1 was tested. The test results showed that the bending force of the oral product prepared by Example 1 was 14.5N±1.2N, and the bending force of the oral product prepared by Comparative Example 1 was 18.5N±2.5N. It can be seen that the oral products prepared by the examples of this application are softer and are conducive to improving the oral comfort of the oral products. However, due to the large pressure of the printing process of the printed mark in Comparative Example 1, the local structure of the oral product is compact, which leads to a decrease in the overall flexibility of the oral product.

[0175] (5) The oral products prepared by Example 1 and Comparative Example 1 were subjected to taste tests, and the test results are shown in Table 8.

[0176] Table 8

[0177] As can be seen from the test data in Table 8, the oral product prepared by Comparative Example 1 experienced a decrease in oral smoothness due to wrinkling and increased hardness on the reverse side. In contrast, the oral product prepared by Example 1 not only had clear printed markings on its surface but also had a smooth surface and high softness, which improved the smoothness and mouthfeel of the oral product, thereby increasing user acceptance and preference. It is evident that the oral product provided by this application, while improving the clarity of the printed markings, did not sacrifice the taste and comfort of the oral product. On the contrary, due to the smoothness of the starch and / or starch derivatives in the printed layer, the overall texture of the oral product was further optimized, making it more acceptable to users.

[0178] In summary, the oral article provided in this application has a first support layer and a second support layer that provide mechanical support. During the preparation of the printed markings in the printed layer, the first and second support layers can buffer the pressure applied to the functional layer, reduce the pressure transmitted to the functional layer, reduce the degree of deformation of the functional layer and the deviation in the content of surfactants caused by the deformation of the functional layer, improve the uniformity of surfactant distribution in the oral article and the consistency of taste during oral use; at least one of the first and second support layers is a water-permeable layer, allowing saliva to penetrate into the functional layer and release the surfactants in the functional layer, providing users with surfactant satisfaction; The printed layer not only provides a carrier for the printed markings on oral products, improving their recognizability, but the starch and / or starch derivatives in the printed layer also enhance its mechanical strength. This allows the printed layer to withstand the pressure exerted on the oral product during the printing process, providing further mechanical support and improving the uniformity of the active agent distribution and the consistency of the mouthfeel during oral use. The oral dissipability of the printed layer allows it to dissipate quickly during oral use, promoting the release of active agents in the functional layer, reducing the stickiness of the printed layer during oral use, and improving the mouthfeel of the oral product.

[0179] The above description, in conjunction with specific embodiments, provides a further detailed explanation of this application and should not be construed as limiting the specific implementation of this application to these descriptions. Those skilled in the art to which this application pertains can make several simple deductions or substitutions without departing from the concept of this application.

Claims

1. A mouth-held product, characterized in that, Includes the base material and the printed layer; The substrate includes a first support layer, a second support layer, and a functional layer, wherein the functional layer is located between the first support layer and the second support layer, at least one of the first support layer and the second support layer is a water-permeable layer, the functional layer includes an active agent, and the printing layer is formed on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer. The printed layer includes a printed logo, the printed layer comprises starch and / or starch derivatives, and the printed layer is orally dissipable.

2. The oral article according to claim 1, characterized in that, The printed layer further includes an colloid; and / or, The printed layer further includes at least one of plasticizer, stabilizer, disintegrant, and food coloring; and / or; The printed layer is adhered to the outer surface of the substrate; and / or The thickness of the printed layer is 0.05mm to 0.15mm.

3. The oral article according to claim 2, characterized in that, The starch includes at least one selected from corn starch, potato starch, tapioca starch, rice starch, wheat starch, and sweet potato starch; and / or, The starch derivative includes at least one selected from hydroxypropyl starch phosphate, sodium carboxymethyl starch, starch acetate, cross-linked starch, hydroxypropyl starch, oxidized starch, pregelatinized starch, and cyclodextrin; and / or, The active agent includes at least one of nicotine and nicotine derivatives; and / or, The colloid comprises at least one of gelatin, pectin, carrageenan, gum arabic, xanthan gum, guar gum, chitosan, sodium alginate, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl starch phosphate, methylcellulose, hydroxypropyl starch, sodium carboxymethyl starch, polyvinylpyrrolidone, polyethylene glycol, sodium polyacrylate, and povidone-iodine; and / or, The plasticizer includes at least one of glycerin, sodium hyaluronate, and propylene glycol; and / or, The stabilizer includes at least one of sodium alginate, xanthan gum, and microcrystalline cellulose; and / or, The disintegrant includes at least one of crospovidone, sodium carboxymethyl starch, sodium crospovidone carboxymethyl cellulose, and hydroxypropyl cellulose.

4. The oral article according to claim 1, characterized in that, In the functional layer, the relative deviation of the surfactant content is less than or equal to 5%; and / or, The moisture content of the oral product is less than or equal to 10%.

5. The oral article according to any one of claims 1 to 4, characterized in that, The functional layer includes at least two sub-functional layers.

6. The oral article according to claim 5, characterized in that, A waterproof layer is also provided between adjacent sub-functional layers.

7. The oral article according to claim 6, characterized in that, The thickness of the waterproof layer is 0.15mm to 0.25mm; and / or, The thickness of the functional layer is 0.15mm~0.3mm; and / or, The thickness of the first support layer is 0.1mm to 0.12mm; and / or, The thickness of the second support layer is 0.1mm to 0.12mm; and / or, The thickness of the sub-functional layer is 0.15mm to 0.3mm.

8. The oral article according to claim 1, characterized in that, The functional layer further includes a film-forming substrate; and / or, the functional layer further includes at least one of a filler, an antioxidant, a flavoring agent, a plasticizer, and a pH adjuster.

9. A method for preparing a mouth-held product, characterized in that, The method for preparing the oral article as described in any one of claims 1 to 8 comprises: A matrix is ​​obtained, the matrix comprising a first support layer, a second support layer and a functional layer, the functional layer being located between the first support layer and the second support layer, at least one of the first support layer and the second support layer being a water-permeable layer, and the functional layer comprising an active agent; Obtain a printing layer paste, wherein the printing layer paste comprises starch and / or starch derivatives; Using the printing paste, a printing layer is formed on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer to obtain the oral article, wherein the printing layer includes a printed logo and the printing layer is orally dissipable.

10. The preparation method according to claim 9, characterized in that, The step of forming a printing layer on the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer using the printing layer paste includes: The printing paste is applied to the outer surface of the first support layer opposite to the functional layer and / or the outer surface of the second support layer opposite to the functional layer to form a coating layer; the coating layer is subjected to a first curing treatment to obtain a first cured layer; a first embossing treatment is performed on the outer surface of the first cured layer to prepare the printed mark on the outer surface of the first cured layer to obtain a first printed cured layer; the first printed cured layer is subjected to a second curing treatment to obtain the printed layer; or... The printing paste is cast into a film to obtain a cast film; the cast film is subjected to a third curing treatment to obtain a second cured layer; a second embossing treatment is performed on either side of the second cured layer to prepare the printed mark on the second cured layer to obtain a second printed cured layer; the second printed cured layer is laminated with the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer, and a fourth curing treatment is performed to form the printed layer on the outer surface of the first support layer away from the functional layer and / or the outer surface of the second support layer away from the functional layer.

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