Buccal product and preparation method thereof

Abstract

The invention discloses a buccal product and a preparation method thereof, and belongs to the technical field of smokeless tobacco products. The buccal product comprises a buccal content, the buccal content comprises a base material, an active agent and an adhesive, the base material is a water-soluble porous base material, the active agent is attached to pores of the base material and / or the surface of the base material, the adhesive coats the active agent and the base material, and the base material, the active agent and the adhesive are 40-90 parts by mass, 0.5-10 parts by mass and 3-7 parts by mass respectively.

Description

Technical Field

[0001] The present application relates to the technical field of smokeless tobacco products, and in particular to an oral product and a preparation method thereof. Background Art

[0002] Oral products are smokeless products containing nicotine. Oral products usually do not need to be burned. Instead, they are placed in the mouth so that nicotine is absorbed by the oral mucosa, providing consumers with a certain nicotine satisfaction through oral administration. Existing oral products have different dissolution rates in the mouth, resulting in unstable nicotine release rates, which affects the user experience. Summary of the invention

[0003] The present application provides an oral product and a preparation method thereof, which can solve the technical problem of unstable nicotine release rate of the oral product.

[0004] In order to solve the above-mentioned technical problems, the present application provides an oral product on the one hand, which includes an oral content, and the oral content includes a substrate, an active agent and an adhesive, wherein the substrate is a water-soluble porous substrate, the active agent is attached to the pores of the substrate and / or the surface of the substrate, and the adhesive coats the active agent and the substrate. In terms of mass parts, the substrate, the active agent and the adhesive are 40-90 parts, 0.5-10 parts and 3-7 parts, respectively.

[0005] In one embodiment, the particle size of the oral contents is 120 μm-320 μm.

[0006] In one embodiment, the substrate comprises at least one of porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose.

[0007] In one embodiment, the pore size of the substrate is 5 μm-30 μm.

[0008] In one embodiment, the particle size of the substrate is 100 μm-300 μm.

[0009] In one embodiment, the active agent includes at least one of synthetic nicotine, natural nicotine, and nicotine derivatives; and / or the binder includes at least one of sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose; and / or the oral preparation further includes at least one of 1-3 parts of a sweetener, 0.5-2 parts of an edible flavor, 0.1-0.5 parts of a preservative, and 0.3-1 parts of an acid-base regulator in parts by mass.

[0010] In one embodiment, the time when 80% of the active ingredient of the active agent in the oral preparation is released is taken as the peak time, and the peak time of the oral preparation is 4 min-32 min.

[0011] On the other hand, the present application provides a method for preparing an oral product, comprising: mixing raw materials to obtain a mixture, wherein the raw materials include the following components, measured by weight: 40-90 parts of a base material and 0.5-10 parts of an active agent, and the base material is a water-soluble porous base material; dissolving a binder in a solvent to obtain a coating solution, wherein, measured by weight, the binder is 3-7 parts and the solvent is 1-40 parts; coating the mixture with the coating solution to obtain coated particles; treating the coated particles to obtain oral contents, and using the oral contents to prepare the oral product.

[0012] In one embodiment, the particle size of the oral contents is 120 μm-320 μm.

[0013] In one embodiment, the substrate comprises at least one of porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose.

[0014] In one embodiment, the pore size of the substrate is 5 μm-30 μm.

[0015] In one embodiment, the particle size of the substrate is 100 μm-300 μm.

[0016] In one embodiment, the raw materials further include at least one of 1-3 parts of a sweetener, 0.5-2 parts of an edible flavor, 0.1-0.5 parts of a preservative, and 0.3-1 parts of an acid-base regulator, in parts by mass.

[0017] In one embodiment, in the step of mixing the raw materials to obtain a mixture, the rotation speed of the mixed raw materials is 300rpm-400rpm, and the mixing time is 15min-20min; and / or, in the step of dissolving the binder in the solvent to obtain a coating solution, the dissolution temperature is 20℃-30℃, the stirring speed is 450rpm-550rpm, and the dissolution time is 1.0h-2.0h; and / or, in the step of coating the mixture with the coating solution to obtain coated particles, the coating treatment temperature is 40℃-50℃, the spray rate is 1.0mL / min-2.0mL / min, and the coating treatment time is 15min-25min; and / or, in the step of treating the coated particles to obtain oral contents, the coated particles are dried using a microwave dryer, the microwave power is 1kg raw material / 3-6kW, and the drying time is 10min-20min.

[0018] The oral preparation provided in the present application is based on the selection of raw material components and the control of the proportional relationship between the raw material components. The substrate is a water-soluble porous substrate, the active agent is attached to the substrate, and the adhesive coats the active agent and the substrate. First, the adhesive forms a coating film outside the substrate, so that the adhesive can control the contact speed between the substrate and water, and then control the release rate of the active ingredient in the active agent attached to the substrate; secondly, the water-soluble porous substrate can be dissolved in water, so that the substrate can further control the release of the active ingredient in the active agent attached to the substrate, thereby stably controlling the release rate of the active ingredient. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0020] Figure 1 It is a schematic diagram of a process of an embodiment of a preparation method provided by the present application;

[0021] Figure 2 is a schematic flow chart of another embodiment of the preparation method provided by the present application;

[0022] Figure 3 is a comparison chart of the dissolution test results of Example A and Comparative Example a;

[0023] Figure 4 is a comparison chart of the dissolution test results of Example A and Comparative Example B;

[0024] Figure 5 is a comparison chart of the dissolution test results of Example A and Comparative Example C;

[0025] Figure 6 is a comparison chart of the dissolution test results of Example A and Comparative Example d;

[0026] Figure 7 is a comparison chart of the dissolution test results of Example A and Comparative Example e;

[0027] Figure 8 2 is a comparison chart of the dissolution test results of Examples AD. DETAILED DESCRIPTION

[0028] The present application is further described in detail below in conjunction with the accompanying drawings and examples. It is particularly noted that the following examples are only used to illustrate the present application, but are not intended to limit the scope of the present application. Similarly, the following examples are only some embodiments of the present application rather than all embodiments, and all other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of the present application.

[0029] In the description of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise clearly and specifically limited. The terms "first", "second", and "third" in the embodiments of the present application are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first", "second", and "third" can explicitly or implicitly include at least one of the features. In the embodiments of the present application, all directional indications (such as up, down, left, right, front, back...) are only used to explain the relative position relationship, movement, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication also changes accordingly. The terms "including" and "having" in the embodiments of the present application and any of their variations are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but optionally also includes steps or units that are not listed, or optionally also includes other steps or components inherent to these processes, methods, products, or devices.

[0030] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0031] The present application provides a method for preparing an oral product. Figure 1 , the preparation method may include steps S10-S40:

[0032] S10, mixing the raw materials to obtain a mixture. Thoroughly mixing the raw materials can make the components in the prepared oral product more evenly distributed, thereby improving the taste of the oral product. The components of the raw materials include a substrate and an active agent. The substrate can be used as a carrier for the active agent. The active agent, as a main active ingredient, can release the active ingredient. The substrate is a water-soluble porous substrate, which can adsorb the active agent. During the mixing of the raw materials, the active agent adheres to the pores of the substrate and / or the surface of the substrate. The water-soluble porous substrate can be dissolved in water. When the oral product is placed in the oral cavity, the main component of saliva is water, and the saliva can dissolve the substrate, so that the substrate can control the release of the active ingredient in the active agent attached to the substrate.

[0033] Wherein, by weight: 40-90 parts of substrate, 0.5-10 parts of active agent. Based on the selection of raw material components and the control of the ratio between the raw material components, the active agent can be attached to the substrate, and in the subsequent coating process, the adhesive can cover the active agent and the substrate.

[0034] In one embodiment, the mass proportion of the substrate may be 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, etc., or a range consisting of any two of the above values, for example, 40-55, 60-85, 50-70, 75-90, etc.

[0035] In one embodiment, the mass proportion of the active agent can be 0.5 parts, 1 parts, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, etc., or a range consisting of any two of the above values, for example, it can be 0.5 parts-5 parts, 6 parts-9 parts, 3 parts-6 parts, 7 parts-10 parts, etc.

[0036] S20, dissolving the binder in a solvent to obtain a coating solution. The binder stabilizes the structure of the oral product, thereby controlling the release rate of the active ingredient. Dissolving the binder in a solvent can fully dissolve the binder, which is beneficial for the binder to be uniformly coated on the active agent and the substrate in the subsequent coating process, thereby enhancing the structural stability of the oral product.

[0037] Wherein, according to the mass parts, the binder is 3-7 parts, and the solvent is 1-40 parts.

[0038] In one embodiment, the mass parts of the adhesive can be 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, etc., or a range consisting of any two of the above values, for example, it can be 3 parts-5 parts, 6 parts-7 parts, 4 parts-6 parts, 5 parts-7 parts, etc.

[0039] In one embodiment, the mass parts of the solvent can be 1 part, 5 parts, 10 parts, 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, etc., or a range consisting of any two of the above values, for example, it can be 1 part-20 parts, 25 parts-40 parts, 5 parts-15 parts, 10 parts-30 parts, etc.

[0040] S30, coating the mixture with a coating solution to obtain coated particles.

[0041] Through the coating process, the adhesive covers the active agent and the substrate, and the adhesive forms a coating film outside the substrate, so that the adhesive can control the contact speed between the substrate and water, and further control the release speed of the active ingredient in the active agent attached to the substrate.

[0042] S40, treating the coated particles to obtain an oral content, and preparing an oral product using the oral content.

[0043] The oral preparation may also include a liquid-permeable bag in which the oral contents are enclosed. The liquid-permeable bag can allow saliva to penetrate, and the saliva can dissolve the substrate, thereby releasing the active ingredient in the active agent attached to the substrate.

[0044] The preparation method provided in the present application is based on the selection of raw material components and the control of the proportional relationship between the raw material components. The substrate is a water-soluble porous substrate, the active agent is attached to the substrate, and the adhesive coats the active agent and the substrate. First, the adhesive forms a coating film outside the substrate, so that the adhesive can control the contact speed between the substrate and water, and then control the release rate of the active ingredient in the active agent attached to the substrate; secondly, the water-soluble porous substrate can be dissolved in water, so that the substrate can further control the release of the active ingredient in the active agent attached to the substrate, thereby stably controlling the release rate of the active ingredient.

[0045] In one embodiment, the substrate includes at least one of porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose. Experiments show that porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose have different dissolution rates in water, so the above substrates can be used to prepare products with different active ingredient release rates to meet the personalized needs of users.

[0046] As the adhesive dissolves in the oral cavity, the active ingredients in the active agent attached to the substrate are continuously released, and the time when the active ingredients of the active agent in the oral product are released by 80% can be taken as the peak time. In one embodiment, the peak time of the oral product is 4min-32min. Specifically, when the substrate is porous gum arabic, the peak time of the oral product is 4min-6min, such as 4min, 5min, 6min, etc., or a range consisting of any two of the above values, such as 4min-5min, 5min-6min, etc., the release rate of the active ingredient is fast, and a quick-release product can be prepared; when the substrate is porous maltodextrin, the peak time of the oral product is 8min-12min, such as 8min, 10min, 12min, etc., or a range consisting of any two of the above values, such as 8min-10min, 10min-12min, etc., the release rate of the active ingredient is faster, and a faster-release product can be prepared; when the substrate is porous maltodextrin, the peak time of the oral product is 8min-12min, such as 8min, 10min, 12min, etc., or a range consisting of any two of the above values, such as 8min-10min, 10min-12min, etc., the release rate of the active ingredient is faster, and a faster-release product can be prepared; when the substrate is When porous starch is used, the peak time of the oral preparation is 18min-22min, such as 18min, 20min, 22min, etc., or a range consisting of any two of the above values, such as 18min-20min, 20min-22min, etc. The release rate of the active ingredient is slow, and a slower release product can be prepared; when the substrate is porous carboxymethyl cellulose, the peak time of the oral preparation is 28min-32min, such as 28min, 30min, 32min, etc., or a range consisting of any two of the above values, such as 28min-30min, 30min-32min, etc. The release rate of the active ingredient is slow, and a slow release product can be prepared. It can be seen that the peak time of the products prepared using the above substrates is different, which can meet the personalized needs of users.

[0047] In one embodiment, the active agent includes at least one of synthetic nicotine, natural nicotine, and nicotine derivatives. Nicotine derivatives include nicotine salts, nicotine substitutes, or salts of nicotine substitutes. Nicotine substitutes include 6-methyl nicotine, and the salts of nicotine substitutes include 6-methyl nicotine salts, such as 6-methyl nicotine tartrate and 6-methyl nicotine benzoate. The active ingredient released by the above-mentioned active agent includes nicotine, thereby providing consumers with a certain nicotine satisfaction.

[0048] In one embodiment, the active agent includes at least one of caffeine and capsaicin. When the active agent includes capsaicin, the active ingredient released by the active agent includes capsaicin; when the active agent includes caffeine, the active ingredient released by the active agent includes caffeine, which can meet various needs of users.

[0049] In one embodiment, the adhesive includes a substance or component with adhesive ability, and the adhesive itself can be attached to the surface of the substrate to form a coating film outside the substrate.

[0050] In one embodiment, the adhesive has no adhesive ability in a non-dissolved state. After being dissolved in a solvent, the adhesive forms a coating solution, and the coating solution has adhesive ability. The mixture is coated with the coating solution, and the adhesive is coated on the outside of the substrate, thereby forming a coating film outside the substrate.

[0051] In one embodiment, the binder includes at least one of sodium carboxymethylcellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose.

[0052] The solvent may include ethanol. In one embodiment, the solvent includes water. Compared with ethanol, the oral product prepared with solvent water has a milder mouthfeel and can reduce irritation to the oral cavity.

[0053] In one embodiment, the raw materials further include at least one of 1-3 parts of sweetener, 0.5-2 parts of edible flavor, 0.1-0.5 parts of preservative and 0.3-1 parts of acid-base regulator in parts by mass. Sweeteners can increase the diversity of taste in oral products. Edible flavors are used to adjust the taste. Preservatives can make oral products less prone to deterioration, thereby ensuring the long-term safety of oral products. Acid-base regulators are used to adjust the pH value of oral products to optimize the stability and release efficiency of active ingredients.

[0054] In one embodiment, the mass proportion of the sweetener may be 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, etc., or a range consisting of any two of the above values, for example, 1 part-2 parts, 2 parts-3 parts, 1 part-2.5 parts, 1.5 parts-3 parts, etc.

[0055] In one embodiment, the sweetener includes at least one of xylitol, sorbitol, mannitol, igltol, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, cyclamate, alitame, steviol glycosides, arabitol, and monk fruit sweetener.

[0056] In one embodiment, the mass proportion of the edible flavor can be 0.5 parts, 0.8 parts, 1 parts, 1.2 parts, 1.5 parts, 1.8 parts, 2 parts, etc., or a range consisting of any two of the above values, for example, it can be 0.5 parts-1 parts, 1.2 parts-2 parts, 0.8 parts-1.5 parts, 1 parts-1.5 parts, etc.

[0057] In one embodiment, the edible flavor includes at least one of mint flavor, watermelon flavor, apple flavor, lemon flavor, vanilla flavor, and citrus flavor.

[0058] In one embodiment, the mass proportion of the preservative can be 0.1 part, 0.2 part, 0.3 part, 0.4 part, 0.5 part, etc., or a range consisting of any two of the above values, for example, it can be 0.1 part-0.3 part, 0.4 part-0.5 part, 0.2 part-0.4 part, 0.3 part-0.5 part, etc.

[0059] In one embodiment, the preservative includes at least one of benzalkonium chloride, sodium chloride, sorbic acid, benzoic acid and its sodium salt, parabens and its sodium salt, disodium edetate, and sodium acetate.

[0060] In one embodiment, the mass fraction of the acid-base regulator can be 0.3 parts, 0.5 parts, 0.7 parts, 0.9 parts, 1 parts, etc., or a range consisting of any two of the above values, for example, it can be 0.3 parts-0.7 parts, 0.7 parts-1 parts, 0.5 parts-0.7 parts, 0.5 parts-0.9 parts, etc.

[0061] In one embodiment, the acid-base regulator includes at least one of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, phosphate, hydroxide, and tris(hydroxymethyl)aminomethane.

[0062] See also Figure 2 In one embodiment, step S05 is further included before step S10:

[0063] S05, screening the substrate to control the particle size of the substrate to be between 100 μm and 300 μm. The substrate can be screened using a raw material screening machine. Screening the substrate can ensure the consistency of the particle size of the substrate, thereby making the dissolution rate of the substrate relatively stable and the peak time of the product in line with expectations.

[0064] Specifically, when the substrate is porous gum arabic or porous maltodextrin, the particle size of the substrate is controlled between 100 μm and 300 μm, such as 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, etc., or a range consisting of any two of the above values, such as 100 μm-200 μm, 200 μm-300 μm, 150 μm-200 μm, 250 μm-300 μm, etc.; when the substrate is porous starch, the particle size of the substrate is controlled between 100 μm and 300 μm, such as 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, etc. The particle size of the substrate is controlled between 150μm and 250μm; when the substrate is porous carboxymethyl cellulose, the particle size of the substrate is controlled between 200μm and 300μm, for example, 200μm, 220μm, 250μm, 280μm, 300μm, etc., or a range consisting of any two of the above values, for example, 200μm-250μm, 250μm-300μm, 220μm-250μm, 250μm-280μm, etc.

[0065] In one embodiment, the pore size of the substrate is 5 μm-30 μm. By controlling the pore size of the substrate, the consistency of the pore size of the substrate can be ensured, thereby making the dissolution rate of the substrate relatively stable and the peak time of the product in line with expectations.

[0066] Specifically, when the substrate is porous gum arabic, the pore size of the substrate is controlled between 5 μm and 15 μm, such as 5 μm, 8 μm, 10 μm, 12 μm, 15 μm, etc., or a range consisting of any two of the above values, such as 5 μm-10 μm, 10 μm-15 μm, 8 μm-12 μm, 10 μm-12 μm, etc.; when the substrate is porous maltodextrin, the pore size of the substrate is controlled between 5 μm and 10 μm, such as 5 μm, 8 μm, 10 μm, etc., or a range consisting of any two of the above values, such as 5 μm-8 μm, 8 μm-10 μm, etc.; when the substrate is porous maltodextrin, the pore size of the substrate is controlled between 5 μm and 10 μm, such as 5 μm, 8 μm, 10 μm, etc., or a range consisting of any two of the above values, such as 5 μm-8 μm, 8 μm-10 μm, etc. When it is porous starch, the pore size of the substrate is controlled between 10μm-15μm, for example, 10μm, 12μm, 15μm, etc., or it is a range composed of any two of the above values, for example, it can be 10μm-12μm, 12μm-15μm, etc.; when the substrate is porous carboxymethyl cellulose, the pore size of the substrate is controlled between 20μm-30μm, for example, 20μm, 22μm, 25μm, 28μm, 30μm, etc., or it is a range composed of any two of the above values, for example, it can be 20μm-25μm, 25μm-30μm, 22μm-25μm, 25μm-28μm, etc.

[0067] In one embodiment, a high-speed mixer is used to mix the raw materials. In the step of mixing the raw materials to obtain the mixture, the rotation speed of the mixed raw materials is 300rpm-400rpm, and the mixing time is 15min-20min. Exemplarily, the rotation speed can be 300rpm, 320rpm, 350rpm, 380rpm, 400rpm, etc., or a range consisting of any two of the above values, such as 300rpm-350rpm, 350rpm-400rpm, 320rpm-350rpm, 380rpm-400rpm, etc.; the mixing time can be 15min, 18min, 20min, etc., or a range consisting of any two of the above values, such as 15min-18min, 18min-20min, etc. By controlling the rotation speed and mixing time of the mixed raw materials, the raw materials can be fully mixed, so that the components in the prepared oral product are distributed more evenly, thereby improving the taste of the oral product.

[0068] In one embodiment, a double-shaft mixer is used to prepare the coating solution. In the step of dissolving the binder in the solvent to obtain the coating solution, the dissolution temperature is 20°C-30°C, the stirring speed is 450rpm-550rpm, and the dissolution time is 1.0h-2.0h. Exemplarily, the dissolution temperature can be 20°C, 22°C, 25°C, 28°C, 30°C, etc., or a range consisting of any two of the above values, for example, it can be 20°C-25°C, 25°C-30°C, 22°C-25°C, 28°C-30°C, etc.; the stirring speed can be 450rpm, 480rpm, 500rpm, 520rpm, 550rpm, etc., or a range consisting of any two of the above values, for example, it can be 450rpm-500rpm, 500rpm-550rpm, 480rpm-520rpm, 500rpm-520rpm, etc.; the dissolution time can be 1.0h, 1.2h, 1.5h, 1.8h, 2.0h, etc., or a range consisting of any two of the above values, for example, it can be 1.0h-1.5h, 1.5h-2.0h, 1.2h-1.8h, 1.5h-1.8h, etc. Based on the control of the dissolution temperature, stirring speed and dissolution time of the coating solution, the adhesive can be fully dissolved, so that the adhesive can better coat the active agent and the substrate, thereby enhancing the structural stability of the oral product.

[0069] In one embodiment, a fluidized bed coating machine is used to prepare coated particles. In the step of coating the mixture with a coating solution to obtain coated particles, the coating treatment temperature is 40°C-50°C, the spray rate is 1.0mL / min-2.0mL / min, and the coating treatment time is 15min-25min. Exemplarily, the coating treatment temperature can be 40°C, 42°C, 45°C, 48°C, 50°C, etc., or a range consisting of any two of the above values, for example, 40°C-45°C, 45°C-50°C, 42°C-48°C, 45°C-48°C, etc.; the spray rate can be 1.0mL / min, 1.2mL / min, 1.5mL / min, 1.8mL / min, 2.0mL / min, etc., or a range consisting of any two of the above values, for example, 1.0mL / min- 1.5mL / min, 1.5mL / min-2.0mL / min, 1.2mL / min-1.8mL / min, 1.5mL / min-1.8mL / min, etc.; coating treatment time is 15min, 18min, 20min, 22min, 25min, etc., or a range consisting of any two of the above values, for example, it can be 15min-20min, 20min-25min, 18min-22min, 20min-22min, etc. By controlling the treatment temperature, spray rate and treatment time in the coating treatment process, the adhesive can coat the active agent and the substrate, thereby effectively regulating the release rate of the active ingredient and stably controlling the release rate of the active ingredient.

[0070] In one embodiment, in the step of treating the coated particles to obtain oral contents, a microwave dryer is used to dry the coated particles, the microwave power is 1kg raw material / 3-6kW, and the drying time is 10min-20min. Exemplarily, the microwave power of 1kg raw material can be 3kW, 4kW, 5kW, 6kW, etc., or a range consisting of any two of the above values, for example, 3kW-4kW, 5kW-6kW, 3kW-5kW, 4kW-6kW, etc.; the drying time can be 10min, 12min, 15min, 18min, 20min, etc., or a range consisting of any two of the above values, for example, 10min-15min, 15min-20min, 12min-18min, 15min-18min, etc. The microwave dryer can ensure accurate moisture control of the product during the production process, thereby extending the shelf life of the product.

[0071] In one embodiment, in the step of processing the coated particles to obtain the oral contents, the dried coated particles are sieved to control the particle size of the oral contents to be between 120 μm and 320 μm. By sieving the coated particles and removing unqualified particles, the consistency of the oral product can be ensured, thereby ensuring that the peak time of the product meets expectations.

[0072] Specifically, when the substrate is porous gum arabic or porous maltodextrin, the mesh number of the sieve is 70-100 mesh, and a finer sieve is used. The particle size of the oral contents is controlled between 100 μm and 300 μm, such as 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, etc., or a range consisting of any two of the above values, such as 100 μm-200 μm, 200 μm-300 μm. μm, 150μm-250μm, 200μm-250μm, etc., so that the particle size of the oral contents is relatively small, and a fast or relatively fast release product can be prepared; when the substrate is porous starch, the mesh number is 60-80 mesh, and a medium mesh is used. The particle size of the oral contents is controlled between 150μm-250μm, such as 150μm, 180μm, 200μm, 220μm, 250μm, etc. Or it can be a range consisting of any two of the above values, for example, it can be 150μm-200μm, 200μm-250μm, 180μm-220μm, 200μm-220μm, etc., so that the particle size of the oral contents is moderate, and the prepared product can balance the release speed and durability; when the substrate is porous carboxymethyl cellulose, the mesh size is 50-70 mesh, and a coarser mesh is used. The particle size of the oral contents is controlled between 200μm-300μm, for example, 200μm, 220μm, 250μm, 280μm, 300μm, etc., or it can be a range consisting of any two of the above values, for example, it can be 200μm-250μm, 250μm-300μm, 220μm-250μm, 250μm-280μm, etc., so that the particle size of the oral contents is larger, and a product with a long release time can be prepared.

[0073] The present application provides an oral product, which includes an oral content, and the oral content includes a substrate, an active agent and an adhesive, wherein the substrate is a water-soluble porous substrate, the active agent is attached to the pores of the substrate and / or the surface of the substrate, and the adhesive covers the active agent and the substrate, and the substrate, the active agent and the adhesive are 40-90 parts, 0.5-10 parts, and 3-7 parts, respectively, by weight. The oral product can be prepared by the preparation method described above. The oral product provided by the present application, based on the selection of raw material components and the control of the proportional relationship between the raw material components, the active agent is attached to the substrate, and the adhesive covers the active agent and the substrate. First, the adhesive forms a coating film outside the substrate, so that the adhesive can control the contact speed of the substrate with water, and then control the release rate of the active ingredient in the active agent attached to the substrate; secondly, the water-soluble porous substrate can be dissolved in water, so that the substrate can further control the release of the active ingredient in the active agent attached to the substrate, thereby stably controlling the release rate of the active ingredient.

[0074] The present application is described below through specific examples, in which oral products are prepared according to the above preparation method. The following examples are only partial examples of the present application and are not intended to limit the present application.

[0075] Example A, the formula is shown in Table 1.

[0076] Table 1 Example A formula

[0077]

[0078] Example B, the formula is shown in Table 2.

[0079] Table 2 Example B formula

[0080]

[0081]

[0082] Example C, the formula is shown in Table 3.

[0083] Table 3 Example C formula

[0084]

[0085]

[0086] Example D, the formula is shown in Table 4.

[0087] Table 4 Example D formula

[0088]

[0089] A comparative example was set according to Example A, and the formula of the comparative example is shown in Table 5.

[0090] Table 5 Comparative Example and Example A

[0091]

[0092]

[0093] The oral preparations prepared in the examples and comparative examples were subjected to dissolution tests.

[0094] Equipment: Dissolution apparatus-paddle method;

[0095] Sample: 1g of each of the powders of Examples A, B, C, D and Comparative Examples a, b, c, d, e;

[0096] Dissolution medium: artificial saliva-pH 6.8;

[0097] Sampling points: 0.5min, 1min, 2min, 5min, 10min, 15min, 20min, 30min, 40min, 60min;

[0098] Test conditions: heating temperature 37°C, speed 100r / min;

[0099] Analysis method: Nicotine content was determined using high performance liquid chromatography.

[0100] The test results are shown in Table 6, Table 7 and Figure 3-Figure 8 shown.

[0101] Table 6 Example test results

[0102]

[0103]

[0104] Table 7 Comparative test results

[0105] Time(min) a(mg) b(mg) c(mg) d(mg) e(mg) 0.5 7.55 3.28 0.33 12.47 6.32 1 9.33 13.42 1.25 36.45 8.64 2 22.52 16.79 1.64 44.21 20.87 5 25.47 28.36 2.25 74.81 25.49 10 28.83 29.22 2.57 85.43 28.85 15 29.12 29.53 2.79 86.07 28.52 20 29.38 29.87 2.95 88.64 29.67 30 29.97 29.63 2.94 88.87 29.95 40 29.69 29.96 2.92 89.96 29.92 60 29.95 29.94 2.97 89.84 29.98

[0106] from Figure 3-Figure 8It can be seen that in comparative examples ad, due to the mismatch in the ratio between the raw material components, the active agent is difficult to adhere to the substrate, or the adhesive is not coated with the active agent and the substrate, the dissolution curve is bent, and the release rate of the active ingredient (nicotine) of the active agent is unstable; in comparative example e, due to the lack of a coating process, the adhesive is difficult to coat the active agent and the substrate, the dissolution curve is bent, and the release rate of nicotine is unstable; relative to comparative example ae, the dissolution curve of Example AD is relatively smooth, that is, the release rate of nicotine in Example AD is more stable. The test results show that the preparation method provided in the present application is based on the selection of raw material components and the control of the proportional relationship between the raw material components. The substrate is a water-soluble porous substrate, the active agent is attached to the substrate, and the adhesive coats the active agent and the substrate, which can stably control the release rate of the active ingredient.

[0107] In addition, from Figure 8 It can be seen that in Examples AD, the substrates are porous gum arabic, porous maltodextrin, porous starch and porous carboxymethyl cellulose, respectively, and the time when 80% of the active ingredient (nicotine) of the active agent in the oral preparation is released is taken as the peak time, and the peak time of the oral preparation is 4min-32min. Specifically, when the substrate is porous gum arabic, the peak time of the oral preparation is 4min-6min, the release rate of nicotine is fast, and the porous gum arabic substrate can be used for fast-release products; when the substrate is porous maltodextrin, the peak time of the oral preparation is 8min-12min, the release rate of nicotine is faster, and the porous maltodextrin substrate can be used for fast-release products; when the substrate is porous starch, the peak time of the oral preparation is 18min-22min, the release rate of nicotine is slower, and the porous starch substrate can be used for slower-release products; when the substrate is porous carboxymethyl cellulose, the peak time of the oral preparation is 28min-32min, the release rate of nicotine is slow, and the porous carboxymethyl cellulose substrate can be used for slow-release products. The products prepared using the above substrates have different peak times, which can meet the personalized needs of users.

[0108] The above descriptions are only some embodiments of the present application, and do not limit the protection scope of the present application. Any equivalent device or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. An oral product, characterized in that: The invention comprises oral contents, which include a substrate, an active agent and an adhesive, wherein the substrate is a water-soluble porous substrate, the active agent is attached to the pores of the substrate and / or the surface of the substrate, and the adhesive covers the active agent and the substrate, and in terms of mass parts, the substrate, the active agent and the adhesive are 40-90 parts, 0.5-10 parts and 3-7 parts respectively.

2. The oral product according to claim 1, characterized in that The particle size of the oral contents is 120 μm-320 μm.

3. The oral product according to claim 1, characterized in that The substrate includes at least one of porous gum arabic, porous maltodextrin, porous starch and porous carboxymethyl cellulose.

4. The oral product according to claim 1, characterized in that The pore size of the substrate is 5 μm-30 μm.

5. The oral product according to claim 1, characterized in that The particle size of the substrate is 100 μm-300 μm.

6. The oral product according to claim 1, characterized in that The active agent comprises at least one of synthetic nicotine, natural nicotine, and nicotine derivatives; and / or, The binder comprises at least one of sodium carboxymethylcellulose, hydroxypropyl methylcellulose, microcrystalline cellulose and low-substituted hydroxypropyl cellulose; and / or, The oral product further comprises at least one of 1-3 parts of a sweetener, 0.5-2 parts of an edible flavor, 0.1-0.5 parts of a preservative, and 0.3-1 parts of an acid-base regulator in parts by mass.

7. The oral product according to any one of claims 1 to 6, characterized in that: The time when 80% of the active ingredient of the active agent in the oral preparation is released is taken as the peak time, and the peak time of the oral preparation is 4min-32min.

8. A method for preparing an oral product, characterized in that: include: The raw materials are mixed to obtain a mixture, wherein the raw materials include the following components by weight: 40-90 parts of a substrate and 0.5-10 parts of an active agent, wherein the substrate is a water-soluble porous substrate; Dissolving the binder in the solvent to obtain a coating solution, wherein the binder is 3-7 parts by weight and the solvent is 1-40 parts by weight; Using the coating solution to coat the mixture to obtain coated particles; The coated particles are treated to obtain oral contents, and the oral product is prepared using the oral contents.

9. The method for preparing the oral product according to claim 8, characterized in that: The particle size of the oral contents is 120 μm-320 μm.

10. The method for preparing an oral product according to claim 8, characterized in that: The substrate includes at least one of porous gum arabic, porous maltodextrin, porous starch and porous carboxymethyl cellulose.

11. The method for preparing an oral product according to claim 8, characterized in that: The pore size of the substrate is 5 μm-30 μm.

12. The method for preparing an oral product according to claim 8, characterized in that: The particle size of the substrate is 100 μm-300 μm.

13. The method for preparing an oral product according to claim 8, characterized in that: The raw materials also include at least one of 1-3 parts of sweetener, 0.5-2 parts of edible flavor, 0.1-0.5 parts of preservative and 0.3-1 parts of acid-base regulator in parts by mass.

14. The method for preparing the oral product according to any one of claims 8 to 13, characterized in that: In the step of mixing the raw materials to obtain a mixed material, the rotation speed of mixing the raw materials is 300 rpm-400 rpm, and the mixing time is 15 min-20 min; and / or, In the step of dissolving the binder in a solvent to obtain a coating solution, the dissolution temperature is 20° C.-30° C., the stirring speed is 450 rpm-550 rpm, and the dissolution time is 1.0 h-2.0 h; and / or, In the step of coating the mixture with the coating solution to obtain coated particles, the coating treatment temperature is 40° C.-50° C., the spray rate is 1.0 mL / min-2.0 mL / min, and the coating treatment time is 15 min-25 min; and / or, In the step of processing the coated particles to obtain oral contents, a microwave dryer is used to dry the coated particles, the microwave power is 1kg raw material / 3-6kW, and the drying time is 10min-20min.

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