Buccal product and preparation method thereof

Abstract

The invention discloses a buccal product and a preparation method thereof, and relates to the technical field of foods or medicines. The buccal product comprises at least one slow-release layer and at least one functional layer which are laminated in the thickness direction, the functional layer comprises a film-forming base material and a functional substance, the film-forming base material is an edible hot melt adhesive, and the functional substance comprises at least one of an active agent and a flavoring agent; the functional layer and the slow release layer are combined through a pressure combination process. The buccal product disclosed by the invention adopts a composite structure combining the functional layer and the slow-release layer, so that stable loading and release of functional substances are ensured, and the mechanical strength and flexibility of the buccal product are also ensured.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of food or medicine, and particularly relates to a mouth product and a preparation method. BACKGROUND

[0002] The mouth product is a new type of oral mucosa drug preparation. Functional substances are combined with excipients to form a film. When used, the film is attached to the oral mucosa. Nicotine is absorbed into the blood circulation through the mucosa, achieving rapid effect.

[0003] In related technologies, a solvent evaporation method is used to prepare a nicotine mouth product. Specifically, nicotine, a film-forming base material, a plasticizer, and other excipients are dissolved in an organic solvent or an aqueous solution to form a uniform film solution. Then, the film solution is coated and dried by heating to remove the solvent. In this way, the film-forming base material and the plasticizer fully extend during the solvent evaporation process, and a nicotine mouth product with high mechanical strength is obtained.

[0004] However, this method relies on high-temperature drying to evaporate the solvent, but at the same time, nicotine and flavors with similar volatility as the solvent are also lost with the solvent. This not only affects the uniformity of the content, but also may cause solvent vapor accumulation due to local high temperature, posing a safety hazard in production. SUMMARY

[0005] The purpose of the embodiments of the present application is to provide a mouth product and a preparation method, which at least solve the problem that functional substances are also lost when the solvent is dried at high temperature in the existing preparation method.

[0006] In a first aspect, the embodiments of the present application provide a mouth product, comprising at least one sustained-release layer and at least one functional layer stacked in the thickness direction; the functional layer contains a film-forming base material and a functional substance, the film-forming base material is selected from edible hot melt adhesive, and the functional substance includes at least one of an active agent and a flavoring agent; the functional layer and the sustained-release layer are combined by a pressure bonding process.

[0007] In some embodiments, the sustained-release layer includes a first sustained-release layer and a second sustained-release layer.

[0008] The functional layer, the first sustained-release layer, and the second sustained-release layer are stacked, and the functional layer is arranged between the first sustained-release layer and the second sustained-release layer.

[0009] In some embodiments, the functional layer includes a plurality of functional layers, and the mouth product further includes a spacer layer, the spacer layer is stacked between different functional layers; at least one functional layer is arranged between the spacer layer and the sustained-release layer; when the number of spacer layers is greater than or equal to two, at least one functional layer is arranged between adjacent two spacer layers.

[0010] In some embodiments, the functional layer comprises a first functional layer comprising a first sub-functional layer; and / or, the functional layer comprises a second functional layer comprising at least a second sub-functional layer and a third sub-functional layer, the second sub-functional layer and the third sub-functional layer being arranged in a stack.

[0011] In some embodiments, the active agent comprises at least one of nicotine, nicotine derivatives; and / or, the film-forming base is at least one of gelatin, glycerol monostearate; and / or, the flavoring agent comprises at least one of a sweetener, a cooling agent, a flavoring; and / or,

[0012] The functional layer further comprises a softening agent; and / or, the functional layer further comprises a pH adjusting agent; and / or, the spacer layer, the first sustained-release layer and the second sustained-release layer are all non-woven fabrics with a thickness of 50-300 μm; and / or, the pressure bonding process is a rolling process.

[0013] In some embodiments, in terms of mass fraction, the fraction of the active agent in the oral preparation is 0.5-20 parts, the fraction of the film-forming base is 20-90 parts, the fraction of the softening agent is 0-30 parts, the fraction of the pH adjusting agent is 0.1-5 parts, the fraction of the sweetener is 1-3 parts, the fraction of the cooling agent is 0.5-1 part, and the fraction of the flavoring is 3-5 parts.

[0014] In a second aspect, the embodiments of the present application provide a preparation method of an oral preparation, comprising: obtaining a functional substance, the functional substance comprising at least one of an active agent, a flavoring agent; obtaining a film-forming base, the film-forming base being selected from edible hot-melt glue; configuring a functional liquid, heating the film-forming base into a fluid state to form a colloid, adding the functional substance into the colloid to form the functional liquid; obtaining a functional layer, coating the functional liquid on a surface of a release carrier and cooling to form the functional layer; obtaining a sustained-release layer; stacking and bonding, stacking the functional layer and the sustained-release layer and bonding by a pressure bonding process to obtain the oral preparation.

[0015] In some embodiments, the step of laminating and combining the functional layer and the slow release layer by pressure bonding process comprises: step S1: laminating one sub-functional layer on a first slow release layer, and applying pressure to combine the sub-functional layer and the first slow release layer to obtain a snus product or snus material; after step S1, the following step S2 is selectively not performed or performed one or more times: step S2: laminating one sub-functional layer on a side of a sub-functional layer of the snus material away from the first slow release layer to obtain a snus product or snus material; after step S1 or after one or more steps S2, the following steps S3, S4, and S5 are selectively not performed or performed one or more times: step S3: obtaining a spacer layer, laminating the spacer layer on a side of a sub-functional layer of the snus material away from the first slow release layer, and applying pressure to combine the spacer layer and the sub-functional layer to obtain a new snus material; step S4: laminating one sub-functional layer on the spacer layer of the snus material, and applying pressure to combine the sub-functional layer and the spacer layer to obtain a new snus material or snus product; step S5: selectively not performing or performing at least one of the above step S2 to obtain a snus material or snus product; after step S1, or after one or more steps S2, or after one or more of the steps S3, S4, and S5, the following step S6 is selectively not performed or performed once: step S6: laminating a second slow release layer on a side of a sub-functional layer of the snus material away from the first slow release layer, and applying pressure to combine the second slow release layer and the sub-functional layer to obtain a snus product.

[0016] In some embodiments, the functional substance comprises at least one of an active agent, a flavoring agent, the step of heating the film-forming base into a fluid form to form a colloid, and adding the functional substance into the colloid comprises the following steps:

[0017] heating the film-forming base into a fluid form to form a colloid at 65-70°C, adding the functional substance into the colloid, and stirring until mixed uniformly; adding a pH adjuster to adjust the pH value to 7-9 to obtain the functional liquid; and / or,

[0018] the step of obtaining the functional layer comprises the following steps: coating the functional liquid onto a surface of a release carrier, and cooling to semi-solid state to obtain the functional layer attached to the surface of the release carrier; and / or,

[0019] the step of laminating and combining the functional layer and the slow release layer by pressure bonding process comprises: laminating the functional layer and the slow release layer, and applying pressure by a roller pressing process to combine the functional layer and the slow release layer.

[0020] In some embodiments, the temperature during the cooling and molding is set to 20-25℃; and / or, the pressure applied in the rolling process is set to 0.3-0.6 MPa.

[0021] In the embodiments of the present application, the oral product comprises at least one slow-release layer and at least one functional layer stacked in the thickness direction; the functional layer comprises a film-forming base material and a functional substance, the film-forming base material is edible hot melt adhesive, and the functional substance comprises at least one of an active agent and a flavoring agent; the functional layer and the slow-release layer are combined by a pressure bonding process, no solvent is added in the oral product, hot melt adhesive is directly used as the base material, the functional substance is added in the hot melt adhesive in a flowable state, the temperature is reduced, the hot melt adhesive is changed into a non-flowable state, no additional heating and drying process is needed, and thus the problem that the functional substance is easy to volatilize in the high-temperature drying and solvent-removing process of the traditional oral film product is avoided, the content of the active ingredient is ensured to be stable; meanwhile, the oral product adopts the composite structure of the functional layer and the double-layer slow-release layer, the stable loading and release of the functional substance are ensured, and the mechanical strength and flexibility of the oral product are ensured. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 is a preparation method flowchart of the oral product provided by the embodiments of the present application. DETAILED DESCRIPTION

[0023] In order to make the above-mentioned objects, features and advantages of the present application more obvious and easy to understand, the present application is further described in detail below with reference to the drawings and specific embodiments.

[0024] The terms "first", "second" in the description and claims of the present application can explicitly or implicitly include one or more features. In the description of the present application, unless otherwise specified, the meaning of "a plurality of" is two or more. In addition, "and / or" in the description and claims means at least one of the connected objects, and the character " / ", generally means that the front and rear associated objects are in an "or" relationship.

[0025] In the process of preparing the oral product, the use of the solvent plays a key role, which is not only a carrier of the film-forming material, but also a medium for uniform dispersion of the active ingredient. Through the solvent evaporation method, the functional substance, the film-forming base material and other high molecular materials can be fully extended to form a dense structure film, thereby giving the oral product good mechanical strength and stability.

[0026] However, due to the solvent evaporation relies on high-temperature drying, and the volatility of active ingredients such as nicotine and flavors is similar to that of the solvent, the active ingredients are easily lost with the solvent during the drying process. This not only causes the actual content of the active ingredients to deviate from the designed value, but also may cause the content of the active ingredients to fluctuate between batches, affecting the uniformity and stability of the product.

[0027] In addition, the volatilization conditions also affect the performance and quality of the finished product. If the temperature is too high, the solvent volatilizes too quickly, which may cause the surface of the film to dry quickly while the solvent remains inside, forming structural defects; but if the temperature is lower, although the volatilization amount of components such as nicotine and flavors is reduced, the production cycle is prolonged, and the production efficiency is reduced. Therefore, how to reduce the loss of active ingredients while ensuring the quality of the film has become an important direction for process optimization.

[0028] To solve the above problems, the embodiments of the present application provide a oral product comprising at least one sustained-release layer and at least one functional layer stacked in the thickness direction. The functional layer contains a film-forming substrate and a functional substance, the film-forming substrate is selected from edible hot melt adhesive, and the functional substance includes at least one of active agent and flavoring agent; the functional layer and the sustained-release layer are combined by pressure bonding process.

[0029] In the present embodiment, the functional layer serves as the core layer, mainly bearing the load and release function of the functional substance, and the film-forming substrate determines the mechanical strength and drug diffusion rate of the oral product. Since at least one functional layer and at least one sustained-release layer are stacked, the rapid release of drugs can be avoided, and stable delivery can be ensured, and the sustained-release layer can also ensure the mechanical strength of the oral product. It should be noted that the functional layer in the present embodiment can be a single-layer functional layer, or two-layer functional layer, or a multi-layer functional layer with more than two layers.

[0030] Unlike the technology of directly coating the functional layer on the sustained-release layer, the liquid of the functional layer seeps through the sustained-release layer during coating, affecting the appearance and use experience of the product. The functional layer and the sustained-release layer of the present embodiment are combined by pressure bonding process, which can prevent the functional liquid for preparing the functional layer from seeping through the sustained-release layer, affecting the appearance or taste.

[0031] In some embodiments, the sustained-release layer includes a first sustained-release layer and a second sustained-release layer, and the functional layer, the first sustained-release layer, and the second sustained-release layer are stacked, wherein the functional layer is arranged between the first sustained-release layer and the second sustained-release layer.

[0032] In some embodiments, the functional layer comprises a plurality of functional layers, and the oral use article further comprises a spacer layer, which is arranged between different functional layers in a stacked manner; wherein at least one functional layer is arranged between the spacer layer and the slow-release layer; when the number of spacer layers is greater than or equal to two, at least one functional layer is arranged between any two adjacent spacer layers. The spacer layer can separate the functional layers, reduce the mutual influence of substances between the functional layers, ensure the stability of the drug in the functional layer, prolong the shelf life, avoid rapid release of the drug, ensure stable delivery, optimize the release behavior of the functional substance, and ensure the mechanical strength of the oral use article to a certain extent.

[0033] In some embodiments, the functional layer comprises a first functional layer, which is composed of only a first sub-functional layer, i.e., a single-layer structure, and the first sub-functional layer is tightly combined with the first slow-release layer and the second slow-release layer on both sides, thereby improving the overall strength of the oral use article and preventing interlayer peeling or breaking.

[0034] In some embodiments, the functional layer comprises a second functional layer, which comprises at least a second sub-functional layer and a third sub-functional layer, and the second sub-functional layer and the third sub-functional layer are arranged in a stacked manner, the first slow-release layer is arranged on the side of the second sub-functional layer away from the third sub-functional layer, and the second slow-release layer is arranged on the side of the third sub-functional layer away from the second sub-functional layer.

[0035] In this embodiment, the second functional layer is composed of the second sub-functional layer and the third sub-functional layer in a stacked manner, i.e., a multi-layer structure, wherein the second sub-functional layer can serve as a rapid-release layer to meet the initial demand, and the third sub-functional layer serves as a slow-release layer to prolong the action time.

[0036] In some embodiments, the active agent comprises a medicament with medical properties, such as lidocaine for treating oral ulcers, methyl salicylate for relieving inflammation and pain, chlorhexidine for sterilization and disinfection, menthol for relieving throat discomfort, etc.

[0037] In some embodiments, the active agent is at least one of nicotine or a nicotine derivative, which can be rapidly released in the oral cavity and act on the nervous system to bring the user a sense of pleasure, thereby effectively relieving the withdrawal symptoms of smokers and assisting the smoking cessation process.

[0038] The nicotine includes natural nicotine and / or synthetic nicotine, and the nicotine derivative includes one or more of nicotine salt, nicotine in a matrix such as a sugar matrix or an organic metal complex, nicotine-resin combination, nicotine inclusion complex, and non-covalently bound nicotine. Among them, the non-covalently bound nicotine includes nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin inclusion complex, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, nicotine benzoate, etc. The nicotine derivative also includes nicotine containing a substituent group, such as one or more of hexamethyl nicotine, hexamethyl nicotine lactate, hexamethyl nicotine malate, hexamethyl nicotine salicylate, hexamethyl nicotine cyclodextrin inclusion complex, hexamethyl nicotine hydrochloride, hexamethyl nicotine dihydrochloride, hexamethyl nicotine tartrate, hexamethyl nicotine tartrate dihydrate, hexamethyl nicotine sulfate, hexamethyl nicotine zinc chloride, and hexamethyl nicotine benzoate. These nicotine derivatives generally have more stable chemical properties or more optimized release performance, and can prolong the action time or improve the use experience.

[0039] In some embodiments, the film-forming base material is at least one of gelatin and glycerol behenate.

[0040] In the present embodiment, gelatin and glycerol behenate are selected as the film-forming base material in the oral preparation. The gelatin and glycerol behenate are edible hot-melt adhesives, and have good film-forming property, biocompatibility, and controllable phase change characteristics. These base materials can form a flexible and structurally stable film, ensuring that the oral preparation maintains its complete form in the oral environment while gradually releasing the active ingredients, and its adhesion helps the film to adhere to the oral mucosa, prolonging the action time. More importantly, the melting temperature of gelatin is 50-66℃, and the melting temperature of glycerol behenate is 65-70℃, which can be uniformly melted without additional water or solvent, greatly simplifying the production process and reducing energy consumption, and avoiding the risk of solvent residue, improving the safety of the product.

[0041] In some embodiments, the flavoring agent comprises at least one of a sweetener, a cooling agent, and a flavor. The sweetener comprises at least one of xylitol, sorbitol, mannitol, isomalt, lactitol, maltitol, isomaltulose, erythritol, maltotriitol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, and steviol glycoside. The sweetener system covers polyols and high potency sweeteners. The polyols not only provide a mild sweetness, but also have the functions of moisturizing and improving the texture of the mouthfeel. The high potency sweeteners can precisely adjust the sweetness level while avoiding excessive calorie intake. The cooling agent comprises at least one of menthol, N-ethyl-2-isopropyl-5-methylcyclohexanecarboxamide, menthyl lactate, menthyl acetate, and menthone glycerol acetal. The flavor comprises at least one of fruit flavor and mint flavor.

[0042] In the oral product, the sweetener provides a mild sweetness, and the cooling agent produces a cooling sensation by activating the cold receptors in the mouth. The cooling stimulation not only effectively masks the pungent taste of nicotine, but also provides a refreshing effect, which positively correlates with the oral needs during smoking cessation. The flavor builds a rich flavor profile through the fruit flavor and / or the mint flavor. For example, the sweet aroma of the fruit flavor can neutralize the bitterness of nicotine, and the mint flavor can enhance the cooling experience and provide fresh breath.

[0043] In some embodiments, the functional layer further comprises a softening agent. The softening agent, such as glycerol and sorbitol, mainly reduces brittleness by retaining moisture or lubricating the molecular chain, ensuring the flexibility of the oral product, preventing brittle cracking, and providing a soft and comfortable mouthfeel. In addition, the softening agent can adjust the release rate of the functional substance.

[0044] In some embodiments, the functional layer further comprises a pH adjuster. The pH adjuster comprises at least one of sodium bicarbonate, sodium carbonate, and sodium citrate. The pH adjuster not only neutralizes the irritation of acidic ingredients, reduces the burning sensation on the oral cavity, and maintains a weak alkaline environment, but also makes nicotine non-ionic in an alkaline environment (pH 8-9), which is less likely to degrade and more easily absorbed through the oral mucosa, thereby enhancing the bioavailability and prolonging the shelf life.

[0045] In some embodiments, the softening agent, the pH adjuster, the sweetener, the cooling agent, and the flavor are auxiliary materials in oral products. The addition of various auxiliary materials can optimize product performance and improve user experience. In terms of mass fraction, the fraction of the active agent in the oral product is 0.5-20 parts, the fraction of the film-forming substrate is 20-90 parts, the fraction of the softening agent is 0-30 parts, the fraction of the pH adjuster is 0.1-5 parts, the fraction of the sweetener is 1-3 parts, the fraction of the cooling agent is 0.5-1 part, and the fraction of the flavor is 1-15 parts.

[0046] In this embodiment, the proportion of the active agent, film-forming base material and other components needs to be accurately controlled. The active agent is the core functional component, and the weight proportion is 0.5-20 parts. If the content is too low, the effect will be insufficient, and if it is too high, it may cause irritation or excessive risk. The film-forming base material is the main structure of the product, and the weight proportion is 20-90 parts. If the proportion is too small, the film strength will be insufficient and easy to break, and if the proportion is too large, it may affect the release rate and taste.

[0047] The softening agent is used to balance flexibility and viscosity, and the weight proportion is 0.5-20 parts. Excessive amount will cause the film formed by the film-forming base material to be too soft to operate, and insufficient amount will cause the film to be brittle. The pH regulator is used to adjust the pH of the functional layer to 7-9, and the weight proportion is 0.1-5 parts. Exceeding the range will change the nicotine release characteristics or cause oral mucosa discomfort. The use of 1-3 parts of sweetener and 0.5-1 part of cooling agent can effectively improve the flavor and avoid the generation of odor or excessive irritation. The use of 1-15 parts of essence can ensure that the flavor is natural and lasting, and too much essence may mask the effect of active ingredients, and too little essence will not be enough.

[0048] In some embodiments, the spacer layer, the first sustained-release layer and the second sustained-release layer are all flexible porous material layers, and the thickness is 50-300 μm.

[0049] In this embodiment, the spacer layer, the first sustained-release layer and the second sustained-release layer are made of non-woven fabric with a thickness of 50-300 μm. The material of the non-woven fabric can be natural cellulose, modified cellulose, synthetic cellulose, polyethylene terephthalate (PET), polyethylene (PE) and the like.

[0050] Taking non-woven fabric as an example, non-woven fabric with a porosity control range of 30-60%, a pore size distribution of 2-7 μm and a thickness of 50-300 μm is selected as the sustained-release layer. It can not only ensure the flexibility of the oral product and ensure comfort without foreign body sensation during use, but also can control the diffusion rate of functional substances through the pore structure of the non-woven fabric.

[0051] In some embodiments, the spacer layer, the first sustained-release layer and the second sustained-release layer are functional support structures, and the main function is to regulate the release behavior of the active ingredients in the functional layer. They do not directly participate in the sustained-release process. By sandwiching the functional layer containing functional substances between the spacer layer and the spacer layer, between the spacer layer and the first sustained-release layer, and / or between the spacer layer and the second sustained-release layer, the release kinetic characteristics of the active ingredients can be significantly optimized.

[0052] In some embodiments, the structure parameters of the non-woven fabric are designed differently, i.e., the first slow-release layer has a relatively high porosity as the oral contact surface, and the spacer layer and the second slow-release layer have a lower porosity. The gradual change in the porosity structure can establish a phased release barrier: the first slow-release layer with a higher porosity allows relatively faster initial release, while the spacer layer and the second slow-release layer with a lower porosity form a stronger barrier to subsequent release, achieving a more stable and sustained release. Furthermore, the mouthpiece product made therefrom has excellent flexibility and tear resistance, ensuring that it does not break during use; and it has a soft texture that perfectly fits the curves of the oral cavity, providing a nearly imperceptible comfortable experience. At the same time, the spacer layer, the first slow-release layer and the second slow-release layer are formed by interlacing fibers, which can quickly absorb excess saliva, reduce the direct impact of the oral cavity on the layered structure of the mouthpiece product, prevent the functional layer from disintegrating too early, and at the same time, avoid the discomfort of "saliva accumulation" and maintain a moderate degree of mucosal moisture.

[0053] In some embodiments, the pressure bonding process is a rolling process. The rolling process is a continuous processing method that applies uniform pressure to the material by pressure rollers. It mainly uses a combination of steel rollers and silicone rollers to implement the transfer of the functional layer and the combination of the functional layer with the slow-release layer, the functional layer with the functional layer, or the functional layer with the spacer layer. At the same time, the rolling process uses a continuous rolling operation method, which improves production efficiency and ensures the stability and continuity of speed and pressure during the rolling process, ensuring the consistency and reliability of the combination between layers.

[0054] In some embodiments, as shown in Figure 1 The preparation method of the mouthpiece product provided by the present embodiment includes steps S101-S106:

[0055] Step S101: obtaining a functional substance, the functional substance including at least one of an active agent and a flavoring agent.

[0056] In some embodiments, when preparing a nicotine mouthpiece product, the functional substance includes at least one of nicotine and a nicotine derivative.

[0057] Step S102: obtaining a film-forming substrate, the film-forming substrate being selected from edible hot-melt glue.

[0058] In some embodiments, gelatin and glyceryl behenate can be selected as the film-forming substrate.

[0059] Step S103: configuring a functional liquid, heating the film-forming substrate into a fluid state to form a colloid, and adding the functional substance to the colloid to form the functional liquid.

[0060] In some embodiments, the film-forming material is placed in a constant temperature water bath, slowly heated to 65-70°C, and continuously stirred to become a fluid form, forming a uniform transparent colloid. After heating to a fluid form, the colloid is transferred to a constant temperature storage container, maintaining the temperature in the range of 65-70°C to prevent the colloid from increasing in viscosity or gelling after cooling, to ensure the smooth progress of the subsequent process. The fluid form is a liquid state with a certain viscosity that can flow.

[0061] The active agent or flavoring agent is added to the colloid, and a mechanical stirrer is used to continuously stir at a speed of 50-200 rpm for 15-20 minutes, until the functional liquid is uniform and free of visible particles or agglomerates.

[0062] In some embodiments, the functional layer further comprises at least one of a softening agent, a sweetener, a cooling agent, and a flavoring agent. At least one of nicotine or a nicotine derivative, and at least one of a softening agent, a pH adjuster, a sweetener, a cooling agent, and a flavoring agent are added to the colloid, and a mechanical stirrer is used to continuously stir at a speed of 50-200 rpm for 15-20 minutes, until the functional liquid is uniform and free of visible particles or agglomerates.

[0063] In some embodiments, the pH of the system is monitored in real time using a pH meter, and the pH is adjusted to the target range of 7-9 by adding a pH adjuster dropwise, with sufficient stirring. The stirrer speed is 50-100 rpm, and after each addition of the pH adjuster, the system is allowed to stabilize for 30 seconds before the next adjustment. The final functional liquid is clear and transparent, with no phase separation and stable pH.

[0064] Step S104: obtaining the functional layer, coating the functional liquid on the surface of the release carrier and cooling to form the functional layer.

[0065] In this step, a release film is selected as the release carrier, and the surface of the release film is divided into a high-gloss front surface and a rough back surface. Before coating, the functional liquid is added to the hopper of the coating machine, and an automatic coating machine is used to coat the functional liquid on the front surface of the release film. During coating, the functional liquid is coated to a thickness of 25-300 μm by adjusting the knife gap and coating head pressure, and the coating speed is stably maintained at 0.1-0.3 m / min. After coating is completed, the release film coated with the functional liquid is naturally cooled at room temperature (20-25°C) to gradually solidify the functional liquid from a liquid state to a semi-solid or solid functional layer. The semi-solid state is a state in which the functional liquid is initially formed without flowing.

[0066] In specific applications, the semi-solid functional layer has certain structural strength and plasticity, making it easier to realize layering and improve the operation convenience of the rolling process. Meanwhile, the semi-solid functional layer has lost obvious fluidity, and the functional liquid of the functional layer will not penetrate through the slow-release layer when subjected to external pressure or long-term static state, thereby avoiding the problem of easy loss of active substances caused by the penetration of the functional liquid of the functional layer.

[0067] Step S105: obtaining a slow-release layer.

[0068] In this embodiment, the slow-release layer comprises a non-woven fabric with a thickness of 50-300 pm. In specific applications, the non-woven fabric is first dried, and after drying, the surface floating hair is removed using high-pressure airflow. Subsequently, the non-woven fabric is accurately cut using an automatic cutting machine. The cutting width should be 1-2 mm wider than the release film, and a 5-10 mm margin should be reserved in the length direction. The cutting edge should be smooth without burrs.

[0069] Step S106: layering and combining, layering the functional layer and the slow-release layer and combining them through a pressure combining process to obtain a mouth product.

[0070] In this step, the rolling process is used for flattening and compounding to combine the functional layer and the slow-release layer, thereby obtaining the mouth product.

[0071] In some embodiments, the layering and combining of the functional layer and the slow-release layer in step S106 through the pressure combining process comprises:

[0072] Step S1: layering a sub-functional layer on a first slow-release layer and applying pressure to combine the sub-functional layer with the first slow-release layer to obtain a mouth product or a mouth material.

[0073] After step S1, the following step S2 is optionally not performed or performed one or more times:

[0074] Step S2: layering a sub-functional layer on a side of a sub-functional layer of the mouth material away from the first slow-release layer to obtain a mouth product or a mouth material.

[0075] After step S1 or after one or more steps S2, the following steps S3, S4, and S5 are optionally not performed or performed one or more times:

[0076] Step S3: obtaining a spacer layer, layering the spacer layer on a side of a sub-functional layer of the mouth material away from the first slow-release layer, and applying pressure to combine the spacer layer with the sub-functional layer to obtain a new mouth material.

[0077] Step S4: Laminating a sub-function layer on the interval layer of the oral material, and applying pressure to combine the sub-function layer with the interval layer, to obtain a new oral material or oral product.

[0078] Step S5: Optionally not performing or performing at least once the above step S2, to obtain an oral material or oral product.

[0079] After step S1, or after one or more steps S2, or after one or more of the steps S3, S4, S5, optionally not performing or performing once the following step S6:

[0080] Step S6: Laminating a second slow-release layer on a side of a sub-function layer of the oral material away from the first slow-release layer, and applying pressure to combine the second slow-release layer with the sub-function layer, to obtain an oral product.

[0081] In the present embodiment, the pressure is applied specifically by a rolling process to combine the first slow-release layer with a sub-function layer, a sub-function layer with a sub-function layer, a sub-function layer with an interval layer, or a sub-function layer with the second slow-release layer.

[0082] It should be noted that in the present embodiment, various structural forms can be produced by combinations of different steps, specifically including the following possible cases:

[0083] The first case is to perform only step S1, at this time a double-layer structure is formed, i.e. a direct composite of the first slow-release layer and a single sub-function layer, which is suitable for a basic oral product.

[0084] The second case is to perform once step S2 after step S1, to form a three-layer structure, i.e. first slow-release layer-sub-function layer-sub-function layer. In the present embodiment, the oral product includes two sub-function layers and a first slow-release layer, and the components contained in the two sub-function layers and the ratio of each component can be different, which improves the diversity of the functional layer, enriches the user experience, and at the same time, the multiple sub-function layers can also increase the amount of functional substances added in the oral product, prolonging the slow-release time.

[0085] The third case is to perform step S2 multiple times after step S1, to build a gradient structure of multiple layers of sub-function layer stacking, and each time step S2 is added, a layer of sub-function is added, and the oral product thus produced can achieve progressive release.

[0086] The fourth case is the combination of step S1-step S3-step S4, and a new sub-function layer is continuously stacked on the interval layer to form a structure of first slow-release layer-sub-function layer-interval layer-sub-function layer, to achieve spatial separation of the functional area.

[0087] The fifth case is a combination of steps S1-S3-S4-S5, specifically, a sub-function layer is added on the basis of the four-layer structure obtained in the fourth case, to obtain a structure of "first slow-release layer-sub-function layer-separation layer-sub-function layer-sub-function layer", creating a more complex multi-layer alternating system, and each functional layer is physically isolated by the separation layer.

[0088] The sixth case is to perform step S5 multiple times on the basis of the structure obtained in the fifth case, and each time step S5 is added, a sub-function layer is added.

[0089] The seventh case is to continue step S6 on the basis of the structure obtained in any one of the first to sixth cases, specifically, a second slow-release layer is stacked on the side of the sub-function layer opposite to the first slow-release layer, and a closed terminal is formed by adding the second slow-release layer, and the second slow-release layer and the first slow-release layer together form a complete controlled-release system.

[0090] The above flexible construction method can create a customized oral preparation structure that meets the requirements of a specific release curve.

[0091] In order to more clearly illustrate the structure and preparation process of the oral preparation in various cases, one of the seventh cases will be described in detail. One of the seventh cases refers to the process of continuing step S6 on the basis of the structure obtained in the first case, including the following steps:

[0092] Step S611: Coating a functional liquid on the surface of the release carrier and curing to form a first sub-function layer, and transferring the first sub-function layer to the first slow-release layer.

[0093] Step S612: Covering a second slow-release layer on the side of the first sub-function layer away from the first slow-release layer to obtain an oral preparation with a structure of first slow-release layer-first sub-function layer-second slow-release layer.

[0094] In this embodiment, before coating, the functional liquid is added to the hopper of the coating machine, and the automatic coating machine is used to coat on the smooth surface of the release film. During coating, the functional liquid is coated to a thickness of 25-300 μm by adjusting the knife gap and coating head pressure, and the coating rate is stably maintained at 0.1-0.3 m / min. After coating, the release film coated with the functional liquid is placed in a room temperature (20-25°C) environment for natural cooling, so that the functional liquid gradually solidifies from a liquid to a semi-solid or solid first sub-function layer, obtaining a composite structure of first sub-function layer-release film.

[0095] Subsequently, the first slow-release layer is evenly coated on the side of the first sub-functional layer away from the release film, and is flattened and transferred using a roller press, wherein the upper roller of the roller press is a silica gel press roller, the lower roller is a steel roller, and the composite pressure is set to 0.3-0.6 MPa, so that the first sub-functional layer is completely transferred to the first slow-release layer, and a composite structure of the first slow-release layer-first sub-functional layer is obtained.

[0096] Finally, the second slow-release layer is coated on the side of the first sub-functional layer away from the first slow-release layer, and is flattened and compounded by roller pressing, and finally a mouthpiece product of the first slow-release layer-first sub-functional layer-second slow-release layer is obtained.

[0097] In this embodiment, the functional layer is composed of the first sub-functional layer, i.e., a single-layer mechanism, and the two sides of the first sub-functional layer are tightly combined with the first slow-release layer and the second slow-release layer, respectively, so as to improve the overall strength of the film and prevent interlayer peeling or fracture.

[0098] In some embodiments, the seventh case is further exemplified. One of the seventh case refers to continuing the process of step S6 on the basis of the structure obtained in the second case, including the following steps: the functional layer includes a second functional layer, and the second functional layer includes at least a second sub-functional layer and a third sub-functional layer.

[0099] Step S621: coating a functional liquid on the surface of the release carrier and solidifying to form a second sub-functional layer, and then transferring the second sub-functional layer to the first slow-release layer.

[0100] Step S622: coating a functional liquid on the surface of the release carrier and solidifying to form a third sub-functional layer, and then transferring the third sub-functional layer to the side of the second sub-functional layer away from the first slow-release layer.

[0101] Step S623: covering a second slow-release layer on the side of the third sub-functional layer away from the first slow-release layer.

[0102] In this embodiment, before coating, the functional liquid is added to the hopper of the coating machine, and the automatic coating machine is used to coat on the smooth surface of the release film. During coating, the functional liquid coating thickness is controlled in the range of 25-300 μm by adjusting the knife gap and coating head pressure, and the coating rate is stably maintained at 0.1-0.3 m / min. After coating, the release film coated with the functional liquid is placed in a room temperature (20-25°C) environment for natural cooling, so that the functional liquid gradually solidifies from liquid to semi-solid or solid second sub-functional layer, and a release film coated with the second sub-functional layer is obtained. The same method is repeated to obtain a release film coated with the third sub-functional layer.

[0103] Subsequently, the first slow-release layer is evenly coated on the side of the second sub-functional layer away from the release film, and is pressed flat and transferred using a roller press, wherein the upper roller of the roller press is a silica gel press roller, the lower roller is a steel roller, and the composite pressure is set to 0.3-0.6 MPa, so that the first sub-functional layer is completely transferred to the first slow-release layer, and a composite structure of the first slow-release layer-second sub-functional layer is obtained.

[0104] The side of the third sub-functional layer away from the first slow-release layer is further covered with the second slow-release layer, and is pressed flat and compounded by roller pressing, to obtain a mouthpiece with a first slow-release layer-second sub-functional layer-third sub-functional layer-second slow-release layer. In this embodiment, the functional layer is composed of the second sub-functional layer and the third sub-functional layer, i.e., a multi-layer structure, wherein the second sub-functional layer can serve as a rapid-release layer to meet the initial demand, and the third sub-functional layer serves as a slow-release layer to prolong the action time.

[0105] The side of the third sub-functional layer away from the first slow-release layer is further covered with the second slow-release layer, and is pressed flat and compounded by roller pressing, to obtain a mouthpiece with a first slow-release layer-second sub-functional layer-third sub-functional layer-second slow-release layer. In this embodiment, the functional layer is composed of the second sub-functional layer and the third sub-functional layer, i.e., a multi-layer structure, wherein the second sub-functional layer can serve as a rapid-release layer to meet the initial demand, and the third sub-functional layer serves as a slow-release layer to prolong the action time.

[0106] Based on the detailed description of the above two typical embodiments, those skilled in the art can easily deduce all other possible structure combinations and corresponding processes by analogy. Although the arrangement and combination of specific steps can produce various changes, the process principles are consistent. The spacer layer can be considered as a slow-release layer in terms of functional nature. For other cases not explicitly listed, the skilled person can deduce the corresponding preparation process and final product structure by adjusting the stacking order and number of each functional unit based on the basic operation logic of steps S1-S6.

[0107] In some embodiments, the mouthpiece is cut to obtain a finished product with an area of 20 mm x 10 mm, and the finished product is sealed and packaged. The packaged product is stored in a dry environment with a humidity of <30% RH to ensure the stability of the product within the shelf life.

[0108] In order to make the purposes, technical solutions and beneficial effects of the present application clearer, the present application will be further described below with reference to examples. It should be understood that these examples are only used to illustrate the present application and do not limit the scope of the present application.

[0109] The present application will be described in detail below through examples.

[0110] Examples 1-4

[0111] The mouthpiece was prepared based on the formulations shown in Table 1 (the components in the formulations were measured by mass fraction) according to the following preparation process:

[0112] Step 1: Place behenicol glyceryl ester in a constant temperature water bath and slowly heat to 65°C while continuously stirring to ensure it reaches a fluid state, forming a uniform and transparent colloid. After reaching a fluid state, transfer the colloid to a constant temperature storage container and maintain the temperature within the range of 65°C.

[0113] Step 2: Prepare the functional liquid by adding nicotine, glycerin, sucralose, sweetener and flavoring to the colloid. Stir continuously for 15-20 minutes at a speed of 50-200 rpm using a mechanical stirrer until the functional liquid is homogeneous and free of visible particles or agglomerates.

[0114] Step 3: Use a pH meter to monitor the acidity and alkalinity of the system in real time. Adjust the pH value to the target range of 7-9 by adding pH adjuster drop by drop. When adjusting, add the pH adjuster drop by drop and stir thoroughly. The stirrer speed should be 50-100 rpm. After each addition of pH adjuster, wait 30 seconds for the pH meter reading to stabilize before making further adjustments. The final functional liquid should be clear and transparent, without phase separation and with a stable pH value.

[0115] Step 4: Add the functional liquid to the hopper of the coating machine and apply it to the smooth surface of the release film using an automatic coating machine. During coating, control the coating thickness of the functional liquid within the range of 25-300μm by adjusting the doctor blade gap and the coating head pressure, and maintain a stable coating rate of 0.1-0.3m / min. After coating, place the release film coated with the functional liquid at room temperature (20-25℃) for natural cooling, allowing the functional liquid to gradually solidify from a liquid state into a semi-solid or solid sub-functional layer, resulting in two release films coated with sub-functional layers, hereinafter referred to as the first release film coating and the second release film coating.

[0116] Step 5: Flatly cover the first sustained-release layer over the side of the neutron functional layer opposite to the release film in the first release film coating, and transfer it using a roller press. The upper roller of the roller press is a silicone roller, and the lower roller is a steel roller. The composite pressure is set to 0.3-0.6MPa to completely transfer the neutron functional layer in the first release film coating to the first sustained-release layer, thus obtaining a composite structure of the first sustained-release layer and the neutron functional layer.

[0117] Step 6: Flatten the spacer layer and cover the side of the sub-functional layer away from the first sustained-release layer in the first release film coating. Use a roller press to flatten and composite the sub-functional layer and the first sustained-release layer to transfer them completely to the spacer layer, thus obtaining a composite structure of first sustained-release layer-sub-functional layer-spacer layer.

[0118] Step 7: Cover the side of the second release film coated with the neutron functional layer away from the release film with the side of the spacer layer obtained in step 6, and use a roller press to flatten and transfer it, so that the second release film coated with the neutron functional layer and the composite structure obtained in step 6 form a strong interface bond, and obtain a composite structure of first sustained-release layer-subfunctional layer-spacer layer-subfunctional layer.

[0119] Step 8: The outermost sub-functional layer of the composite structure obtained in step 7 is covered with a second slow-release layer on the side away from the spacer layer, and a roller press is used to flatten and compound, obtaining a mouthpiece with the structure of first slow-release layer-sub-functional layer-spacer layer-sub-functional layer-second slow-release layer.

[0120] Step 9: The mouthpiece is cut to obtain multiple samples with an area of 20x10 mm, and the samples are tested for nicotine volatilization, nicotine dissolution, peel strength, and flavor.

[0121] Table 1

[0122]

[0123] Comparative Example 1

[0124] A nicotine oral film was selected.

[0125] The samples prepared in Examples 1-4 and Comparative Example 1 were tested as follows:

[0126] (1) The nicotine volatilization of the samples of Examples 1-4 and Comparative Example 1 was tested: First, the samples of the examples and the comparative example were all cut into 10 mm x 10 mm specifications and placed in a constant temperature and humidity chamber at 25°C and 60% relative humidity for accelerated volatilization experiments. Then, after sampling at different time points, methanol-phosphate buffer mixed solution was used for ultrasonic assisted extraction, and the test solution was obtained after centrifugal filtration. Then, HPLC analysis was continued on a C18 reverse phase chromatographic column, with acetonitrile-phosphate buffer as the mobile phase for gradient elution, and the nicotine characteristic absorption peak was detected at a wavelength of 260 nm. Quantitative calculation was carried out by the previously established 0.1-10 μg / mL nicotine standard curve, and the volatilization rate was calculated based on the nicotine content in the sample stored in a sealed container, and the results are shown in Table 2.

[0127] (2) The nicotine dissolution of the samples of Examples 1-4 and Comparative Example 1 was tested: The samples were placed in a dissolution instrument (paddle method, USP II), then 500 mL of simulated saliva (pH 6.8, containing 0.5% SDS) was added, the temperature was controlled at 37°C±0.5°C, and the rotation speed was 100 rpm, then the sample solution was filtered through a 0.22 μm filter at 0.5, 1, 3, 5, 10, 15, 30, 60 minutes, and then the filtrate was sent to HPLC (C18 column, detection wavelength 260 nm) to detect the nicotine concentration, and the cumulative release rate (%) was calculated as [(total nicotine content detection concentration x dissolution medium volume) ÷ total nicotine content] x 100, and the results are shown in Table 3.

[0128] (3) The peeling force of the samples prepared in Examples 1-4 was tested using a universal material testing machine: first, check the configuration state of the peeling fixture, ensure that the upper clamp is a small special fixture, and the lower clamp is correctly selected according to the test requirements 90° peeling force fixture or 180° fixture; second, check the installation direction of the electronic push-pull force meter, confirm that the display panel "pull" (pulling force) mark is facing down, and firmly install the instrument on the test support; finally, clamp the sample flat between the upper and lower fixtures, keep the sample force direction aligned with the fixture center line, start the test program for measurement, repeat three times, take the average value, and the results are shown in Table 4.

[0129] (4) The aroma of the samples of Examples 1-4 and Comparative Example 1 was evaluated respectively: first, select 15 panelists with high taste recognition ability and good health without disease for sensory evaluation. The panelists should not smoke, drink or eat food with strong odor within 2 hours before evaluation. Each sample was placed between the upper lip and gum, the aroma of the sample was perceived and evaluated. Each sample was tasted for 5 minutes, then spit out, rinsed the mouth until there was no residual taste, and the next sample was measured after 10 minutes, and the final comprehensive evaluation result was taken as the test result. The test results are shown in Table 5.

[0130] Table 2

[0131]

[0132] Table 3

[0133]

[0134]

[0135] Table 4

[0136]

[0137] Table 5

[0138]

[0139] From the nicotine volatilization rate test results in Table 2, it can be seen that the nicotine content of the comparative nicotine oral film showed a rapid downward trend with the extension of time under open storage conditions, confirming that there was a significant volatilization loss phenomenon, while the nicotine volatilization rate of the samples in the present application was smaller.

[0140] As can be seen from the test results of the cumulative release amount of nicotine in Table 3, with the increase of the glycerol content, the release rate of nicotine of the oral product is significantly accelerated. Example 1 does not contain glycerol, and the release of nicotine is the slowest, with a cumulative release amount of 82.51% at 30 minutes; while Example 4 contains 30 parts of glycerol, the release of nicotine is close to complete (98.45%) at the same time, and the release rate in the first 30 minutes is significantly higher than that of other groups. This shows that glycerol as a hydrophilic component can promote the dissolution and diffusion of functional substances, thereby affecting the onset time of the product.

[0141] As can be seen from the mechanical property test results in Table 4, the addition of glycerol significantly improves the peel force of the oral product. When Example 1 does not contain glycerol, the peel force is only 1.01 N, and with the increase of the glycerol content from 0 parts to 30 parts, the peel force increases from 4.25 N (Example 2) to 7.05 N (Example 4). This change trend shows that glycerol plays a plasticizing role in the system, which can improve the flexibility and cohesive strength of the glycerol behenate matrix, making the functional layer more easily attached and not easily broken.

[0142] As can be seen from the sensory evaluation results in Table 5, the oral product designed by the present application with a double-layer slow-release structure combined with an intermediate functional layer exhibits a significant advantage in aroma retention. By arranging the functional layer between the two slow-release layers, not only is the effective control of active ingredients such as nicotine achieved, but more importantly, a barrier protection for volatile components is formed, reducing the loss of volatile components such as fragrances, so that the product maintains a stable aroma intensity throughout the use process. Compared with the rapid aroma decay problem of the oral film product of the comparative example, the structural design of the present application achieves the technical effect of long-lasting and stable aroma through the synergistic effect of physical barrier and controlled release.

[0143] In summary, the oral product provided by the embodiments of the present application avoids the addition of solvents, thereby avoiding the problem of volatilization of functional substances caused by high-temperature drying in the traditional solvent volatilization method, ensuring the stability of the content of active ingredients; at the same time, the oral product adopts a composite structure of a functional layer and a double-layer slow-release layer, which not only ensures the stable loading and release of functional substances, but also ensures the mechanical strength and flexibility of the oral product.

[0144] Although the preferred embodiments of the embodiments of the present application have been described, those skilled in the art can make additional changes and modifications to these embodiments once they know the basic creative concept. Therefore, the claims are intended to include the preferred embodiments and all changes and modifications falling within the scope of the embodiments of the present application.

[0145] The above describes in detail the oral product and the preparation method thereof provided by the present application. The principles and implementation manners of the present application are described by using specific examples. The above description of the examples is only used to help understand the method of the present application and the core idea thereof. Meanwhile, for those skilled in the art, the specific implementation manners and application ranges will be changed according to the idea of the present application. In conclusion, the content of the present description should not be understood as a limitation on the present application.

Claims

1. A mouthpiece, characterized in that The oral product comprises at least one slow-release layer and at least one functional layer stacked in the thickness direction; the functional layer comprises a film-forming base material and a functional substance, the film-forming base material is edible hot melt adhesive, and the functional substance comprises at least one of an active agent and a flavoring agent; the functional layer is combined with the slow-release layer through a pressure bonding process.

2. A smokeless tobacco product according to claim 1, wherein The slow-release layer comprises a first slow-release layer and a second slow-release layer. The functional layer, the first slow-release layer, and the second slow-release layer are stacked, and the functional layer is arranged between the first slow-release layer and the second slow-release layer.

3. A smokeless tobacco product according to claim 2, wherein The functional layer comprises a plurality of functional layers, and the oral product further comprises a spacer layer stacked between different functional layers; at least one functional layer is arranged between the spacer layer and the slow-release layer; when the number of spacer layers is greater than or equal to two, at least one functional layer is arranged between adjacent two spacer layers.

4. A mouthpiece according to any one of claims 1 to 3, characterised in that, The functional layer comprises a first functional layer, and the first functional layer comprises a first sub-functional layer; and / or, The functional layer comprises a second functional layer, and the second functional layer comprises at least a second sub-functional layer and a third sub-functional layer, and the second sub-functional layer and the third sub-functional layer are stacked.

5. The oral product according to claim 4, wherein, The active agent comprises at least one of nicotine and a nicotine derivative; and / or, The film-forming base material is at least one of gelatin and glycerol monostearate; and / or, The flavoring agent comprises at least one of a sweetener, a cooling agent, and a flavoring essence; and / or, The functional layer further comprises a softening agent; and / or, The functional layer further comprises a pH adjuster; and / or, The spacer layer, the first slow-release layer, and the second slow-release layer are all non-woven fabrics with a thickness of 50-300 μm; and / or, The pressure bonding process is a rolling process.

6. A smokeless tobacco product according to claim 5, wherein In terms of mass fraction, the fraction of the active agent in the oral product is 0.5-20 parts, the fraction of the film-forming base material is 20-90 parts, the fraction of the softening agent is 0-30 parts, the fraction of the pH adjuster is 0.1-5 parts, the fraction of the sweetener is 1-3 parts, the fraction of the cooling agent is 0.5-1 part, and the fraction of the flavoring essence is 3-5 parts.

7. A method of making a mouthpiece, characterized in that The method comprises: obtaining a functional substance comprising at least one of an active agent and a flavoring agent; obtaining a film-forming base material selected from edible hot melt adhesive; configuring a functional liquid by heating the film-forming base material into a fluid state to form a colloid, and adding the functional substance into the colloid to form the functional liquid; obtaining a functional layer by coating the functional liquid on the surface of a release carrier and cooling to form the functional layer; obtaining a slow-release layer; stacking and combining the functional layer and the slow-release layer through a pressure bonding process to obtain the oral product.

8. The preparation method of the oral product according to claim 7, wherein, the stacking and combining the functional layer and the slow-release layer through a pressure bonding process comprises: Step S1: laminating a sub-function layer on the first slow-release layer, and applying pressure to combine the sub-function layer with the first slow-release layer, to obtain a mouthpiece or a mouthpiece material; Optionally, after step S1, or after one or more steps S2, the following steps S3, S4, S5 are optionally not performed or performed one or more times: Step S2: laminating a sub-function layer on the side of the mouthpiece material away from the first slow-release layer, to obtain a mouthpiece or a mouthpiece material; Optionally, after step S1, or after one or more steps S2, the following steps S3, S4, S5 are optionally not performed or performed one or more times: Step S3: obtaining a spacer layer, laminating the spacer layer on the side of the mouthpiece material away from the first slow-release layer, and applying pressure to combine the spacer layer with the sub-function layer, to obtain a new mouthpiece material; Step S4: laminating a sub-function layer on the spacer layer of the mouthpiece material, and applying pressure to combine the sub-function layer with the spacer layer, to obtain a new mouthpiece material or a mouthpiece; Step S5: optionally not performing or performing at least once the above step S2, to obtain a mouthpiece material or a mouthpiece; Optionally, after step S1, or after one or more steps S2, or after one or more steps S3, S4, S5, the following step S6 is optionally not performed or performed once: Step S6: laminating a second slow-release layer on the side of the mouthpiece material away from the first slow-release layer, and applying pressure to combine the second slow-release layer with the sub-function layer, to obtain a mouthpiece.

9. The method of claim 7 or 8, wherein the functional substance comprises at least one of an active agent and a flavoring agent, the heating of the film-forming base into a fluid form to form a colloid, and the adding of the functional substance into the colloid comprise the following steps: heating the film-forming base into a fluid form at 65-70°C to form a colloid, adding the functional substance into the colloid, and stirring until mixed uniformly; adding a pH adjuster to adjust the pH value to 7-9, to obtain the functional liquid; and / or the obtaining of the functional layer comprises the following steps: coating the functional liquid onto the surface of a release carrier, and cooling to semi-solid state to obtain the functional layer attached to the surface of the release carrier; and / or the laminating of the functional layer with the slow-release layer and the combining by pressure comprise: laminating the functional layer with the slow-release layer, and applying pressure by a rolling process to combine the functional layer with the slow-release layer.

10. The method of claim 9, wherein the temperature during the cooling and shaping is set to 20-25°C; and / or the pressure applied by the rolling process is set to 0.3-0.6 MPa. ​ ​ ​

Images