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 food. The buccal product comprises a permeable bag and a composition encapsulated in the permeable bag, the composition comprises a natural base material, a filling agent and an active agent, the natural base material is used for providing natural caffeine, and the filling agent comprises a water-insoluble material; the composition is prepared from the following components in parts by mass: 10 to 50 parts of natural base material, 43 to 70 parts of filling agent and 0.5 to 30 parts of active agent. According to the embodiment of the invention, the bitterness and irritation of the natural caffeine component provided by the natural base material and the refreshing active component provided by the active agent can be reduced, the natural flavor of the buccal product is enhanced, the taste of the buccal product is improved, a mild refreshing effect is provided for a user, and the taste and safety of the buccal product are improved.

Description

Technical Field

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

[0002] Caffeine oral products are products that contain caffeine and allow consumers to ingest caffeine through oral administration.

[0003] In the related art, caffeine-containing oral products mainly use pure caffeine monomer as raw material; however, pure caffeine monomer has a strong bitter taste and is highly irritating, and when the caffeine monomer content is high, it will have adverse effects on human health (for example, causing symptoms such as tachycardia, insomnia, and anxiety), resulting in safety risks in caffeine-containing oral products. Summary of the Invention

[0004] The present application provides an oral product and a preparation method thereof, which are used to solve the problems of low safety and poor taste of caffeine oral products in the related art.

[0005] To solve the above technical problems, the present application provides an oral product, which includes a permeable bag and a composition encapsulated in the permeable bag, wherein the composition includes a natural base material, a filler and an active agent, wherein the natural base material is used to provide natural caffeine, and the filler includes a water-insoluble material; in the composition, measured by mass, the natural base material is 10 to 50 parts, the filler is 43 to 70 parts, and the active agent is 0.5 to 30 parts.

[0006] In one embodiment, the active agent includes at least one of caffeine monomer, theophylline, theobromine, paratheobromine, quercetin, ephedrine, pseudoephedrine, modafinil and methylphenidate; and / or the natural substrate includes at least one of coffee powder, tea powder and guarana powder.

[0007] In one embodiment, the filler includes a main filler and an auxiliary filler; in the composition, measured by mass, the main filler is 30 parts to 50 parts, and the auxiliary filler is 13 parts to 20 parts.

[0008] In one embodiment, the main filler includes at least one of microcrystalline cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, micropowdered silica gel and modified starch; and / or the auxiliary filler includes at least one of xylitol, mannitol, lactitol, maltitol, erythritol, isomalt, calcium phosphate and calcium sulfate.

[0009] In one embodiment, the composition further comprises at least one of a binder, a pH regulator, a salting agent, a sweetener, a cooling agent, and a flavor.

[0010] In one embodiment, the binder includes at least one of sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, sodium alginate, gum arabic, β-cyclodextrin and pectin; and / or, the acid-base regulator includes at least one of sodium carbonate, sodium bicarbonate, citric acid and lactic acid; and / or, the salting agent includes at least one of sodium chloride and potassium chloride; and / or, the sweetener includes sucralose, neotame, aspartame, acesulfame potassium, steviol glycosides, xylitol, iglesia, mannitol, sorbitol, erythritol, maltitol, lactitol, saccharin sodium , at least one of mongoose, sukram, agave sugar, maple syrup, fructose, alitame, cyclamate, monk fruit sweet and glycoside advantam; and / or, the cooling agent includes at least one of N-ethyl-(2-isopropyl-5-methyl)cyclohexaneamide, N,2,3-trimethyl-2-(1-methylethyl)butanamide, N-(ethoxycarbonylmethyl)-p-menthane-3-carboxamide, N-ethyl-2,2-diisopropylbutanamide, N-(4-methoxyphenyl)-p-menthyl-3-carboxamide, menthols and isomenthol.

[0011] In one embodiment, the composition further includes a binder, an acid-base regulator, a salting agent, a sweetener, a cooling agent and a flavor; in the composition, measured by mass, the binder is 1 to 10 parts, the acid-base regulator is 0.5 to 5 parts, the salting agent is 0.2 to 3 parts, the sweetener is 0.2 to 2 parts, the cooling agent is 0.1 to 2 parts, and the flavor is 0.1 to 5 parts.

[0012] In one embodiment, the water content of the composition is less than or equal to 35 wt %.

[0013] The present application provides a method for preparing an orally contained product, the method comprising: obtaining crushed natural substrates, wherein the natural substrate is used to provide natural caffeine; mixing a filler, an active agent, and the crushed substrate to prepare a solid mixture product, wherein the filler comprises a water-insoluble material; granulating the solid mixture product to prepare a composition, wherein, in the composition, the natural substrate accounts for 10 to 50 parts, the filler accounts for 43 to 70 parts, and the active agent accounts for 0.5 to 30 parts, measured by mass; and packaging the composition into a permeation bag to obtain an orally contained product.

[0014] In one embodiment, the granulation based on the solid mixture product to prepare the composition includes: preparing a liquid mixture product, wherein the liquid mixture product includes at least one of a binder, a salting agent, a sweetener, a cooling agent and a flavor; and mixing and granulating the solid mixture product with the liquid mixture product to prepare the composition.

[0015] The oral preparation provided by the present application includes a permeable bag and a composition encapsulated in the permeable bag, wherein the composition includes a natural base material, a filler, and an active agent, and the mass fraction of each component in the composition is controlled so that the ratio between the natural base material, the filler, and the active agent in the composition is appropriate; wherein the natural base material can provide a natural caffeine component, and as the composition in the oral preparation disintegrates in the oral cavity, the natural caffeine provided by the natural base material can be released in the oral cavity, providing a mild refreshing effect for the user, and the active agent can provide a refreshing active ingredient. By adjusting the mass fraction of the active agent in the composition, on the basis of the refreshing effect of the natural caffeine component, The refreshing effect of the oral preparation is further improved by the refreshing active ingredients. In addition, the natural base material also has a natural aroma, which is beneficial to enhancing the natural flavor of the oral preparation and improving the taste of the oral preparation; the filler includes a water-insoluble material, which can improve the physical stability of the composition, improve the disintegration and solubility of the composition in the oral cavity, and make the release process of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition more uniform, which is beneficial to reduce the bitterness and irritation of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent, thereby improving the taste and safety of the oral preparation provided in the embodiment of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 A flowchart of the steps of a method for preparing an oral product provided in this application;

[0017] Figure 2 A comparison chart of caffeine content test results provided in this application;

[0018] Figure 3 A comparison chart of pH value test results provided in this application;

[0019] Figure 4 A comparison chart of oral epithelial cell survival rate test results provided in this application;

[0020] Figure 5 This is a caffeine dissolution curve diagram of Example 1 provided in this application;

[0021] Figure 6 This is a caffeine dissolution curve diagram of Example 2 provided in this application;

[0022] Figure 7 This is a caffeine dissolution curve diagram of Example 3 provided in this application;

[0023] Figure 8 This is a caffeine dissolution curve diagram of Example 4 provided in this application. DETAILED DESCRIPTION

[0024] The present application is further described in detail below by means of specific embodiments in conjunction with the accompanying drawings. In the following embodiments, many detailed descriptions are provided to enable the present application to be better understood. However, those skilled in the art will readily appreciate that some of the features may be omitted in different circumstances, or may be replaced by other materials or methods. In some cases, some operations related to the present application are not shown or described in the specification. This is to avoid overwhelm the core of the present application with excessive descriptions, and for those skilled in the art, it is not necessary to describe these related operations in detail. They can fully understand the related operations based on the description in the specification and the general technical knowledge in the art.

[0025] In addition, the features, operations, or characteristics described in the specification may be combined in any appropriate manner to form various embodiments. Furthermore, the steps or actions in the method description may be reordered or adjusted in a manner readily apparent to those skilled in the art. Therefore, the various sequences in the specification and drawings are provided solely for the purpose of clearly describing a particular embodiment and are not intended to be mandatory, unless otherwise specified.

[0026] The serial numbers assigned to the components in this document, such as "first", "second", etc., are only used to distinguish the objects described and do not have any order or technical meaning.

[0027] In the related art, caffeine-containing oral products mainly use pure caffeine monomer as raw material; however, pure caffeine monomer has a strong bitter taste and is highly irritating, which seriously affects the taste of the oral products. In addition, when the caffeine monomer content is high, it can also have adverse effects on human health (for example, causing symptoms such as tachycardia, insomnia, and anxiety), resulting in safety risks in caffeine-containing oral products.

[0028] In addition, pure caffeine monomer is not stable enough under certain environmental conditions and is easily affected by factors such as light, humidity, and temperature, causing problems such as decomposition, deterioration, moisture absorption, and agglomeration, further reducing the taste of oral products.

[0029] To address the above-mentioned issues, the present invention provides an oral product comprising a natural base material, a filler, and an active agent. In the composition, the natural base material comprises 10 to 50 parts, the filler comprises 43 to 70 parts, and the active agent comprises 0.5 to 30 parts by weight.

[0030] In the embodiments of the present application, a natural substrate is used to provide natural caffeine. As the composition in the oral preparation disintegrates in the oral cavity, the natural caffeine provided by the natural substrate can be released in the oral cavity and absorbed by the oral mucosa, providing the user with a mild refreshing effect. The present application utilizes a natural substrate to provide natural caffeine, which can avoid the problem of strong irritation of caffeine monomers in related technologies; furthermore, the natural substrate also has a natural aroma, which is beneficial to enhancing the natural flavor of the oral preparation, improving the taste richness of the oral preparation, and thereby improving the taste of the oral preparation.

[0031] The active agent is used to provide a refreshing active ingredient, which can act on the central nervous system, antagonize adenosine receptors, and improve alertness; the refreshing active ingredients can include but are not limited to: methylxanthine compounds, flavonoid compounds, alkaloids and central nervous system stimulants, etc.; in the embodiments of the present application, by adjusting the mass fraction of the active agent in the composition, the refreshing effect of the oral preparation can be further improved by the refreshing active ingredient on the basis of the refreshing effect of natural caffeine, thereby improving the refreshing effect of the oral preparation while ensuring the safety of the oral preparation and reducing the drug control risk of the oral preparation, avoiding the problems of bitterness and strong stimulation caused by the use of a single caffeine monomer as a raw material in the related art, improving the applicability of the oral preparation, and expanding the application range of the oral preparation.

[0032] The filler includes a water-insoluble material, which can reduce the hygroscopicity of the composition in the oral product, prevent the composition from caking due to moisture absorption, and improve the physical stability, disintegration and solubility of the composition, so that the release process of the natural caffeine provided by the natural base material and the refreshing active ingredients provided by the active agent in the oral cavity is more uniform and stable, which is conducive to further improving the taste and refreshing effect of the oral product during consumption.

[0033] In some embodiments, the permeable bag in the oral product is used to encapsulate the composition. When the oral product is placed in the mouth, saliva can penetrate the permeable bag, causing some of the composition to dissolve in the saliva and then be released through the permeable bag to the outside for consumption by the user. Specifically, the natural caffeine component provided by the natural substrate and the active ingredient provided by the active agent can be released into the saliva within the permeable bag, then permeate through the saliva to the outside of the permeable bag for absorption or consumption by the user.

[0034] In some embodiments, the permeable bag is insoluble in water; specifically, the permeable bag may be a heat-sealable small bag, and the material of the permeable bag may include but is not limited to non-woven fabrics.

[0035] The oral product provided in the embodiment of the present application includes a permeable bag and a composition encapsulated in the permeable bag, wherein the composition includes a natural base material, a filler and an active agent, and the mass fraction of each component in the composition is controlled so that the ratio between the natural base material, the filler and the active agent in the composition is appropriate; wherein the natural base material can provide a natural caffeine component, and as the composition in the oral product disintegrates in the oral cavity, the natural caffeine provided by the natural base material can be released in the oral cavity, providing the user with a mild refreshing effect, and the active agent can provide a refreshing active ingredient. By adjusting the mass fraction of the active agent in the composition, on the basis of the refreshing effect of the natural caffeine component, The refreshing active ingredients further improve the refreshing effect of the oral preparation. In addition, the natural base material also has a natural aroma, which is beneficial to enhancing the natural flavor of the oral preparation and improving the taste of the oral preparation. Furthermore, the filler includes a water-insoluble material, which can improve the physical stability of the composition, improve the disintegration and solubility of the composition in the oral cavity, and make the release process of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition more uniform, which is beneficial to reduce the bitterness and irritation of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent, thereby improving the taste and safety of the oral preparation provided by the embodiment of the present application.

[0036] In some embodiments, the active agent may include at least one of caffeine monomer, theophylline, theobromine, paratheobromine, quercetin, ephedrine, pseudoephedrine, modafinil and methylphenidate. Thus, on the basis of the refreshing effect of the natural caffeine component, the refreshing active ingredient provided by the active agent can further improve the refreshing effect of the oral preparation.

[0037] In some embodiments, the active agent may include at least one of nicotine and a nicotine derivative. Nicotine includes at least one of synthetic nicotine and natural nicotine. Nicotine derivatives include one or more of nicotine salts, nicotine in a matrix such as a sugar matrix or an organometallic complex, a nicotine-resin combination, a nicotine inclusion complex, and non-covalently bound nicotine. Among them, 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. Nicotine derivatives also include nicotine containing substituents, such as hexamethyl nicotine, hexamethyl nicotine lactate, hexamethyl nicotine malate, hexamethyl nicotine salicylate, hexamethyl nicotine cyclodextrin embedded 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. One or more mixtures thereof.

[0038] In some embodiments, the natural base material in the oral product includes at least one of coffee powder, tea powder and guarana powder, thereby providing natural caffeine in the composition, which not only provides a mild refreshing effect to the user, but also increases the richness of the taste of the oral product and improves the taste of the oral product.

[0039] In some embodiments, the filler in the buccal preparation includes a primary filler and a secondary filler.

[0040] Among them, the main filler is mainly an insoluble, tasteless, and calorie-free filler, and the main filler has good compressibility, disintegration and low hygroscopicity, which is beneficial to improving the uniformity and fluidity of the composition powder in the oral preparation, improving the compressibility, disintegration and solubility of the composition, and thus improving the stability and uniformity of the release process of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition; in addition, the main filler can also enhance the physical stability of the composition, prevent the composition from absorbing moisture and agglomerating, and help further improve the taste and refreshing effect of the oral preparation during taking.

[0041] In some embodiments, in the composition, the main filler is 30 to 50 parts by mass. Within this range, the main filler can fully exert its effect in improving the physical stability, compressibility, disintegration, solubility of the composition, and the stability and uniformity of the release process.

[0042] In some embodiments, the primary filler comprises at least one of microcrystalline cellulose, sodium carboxymethyl cellulose, hypromellose, ethyl cellulose, micronized silica, and modified starch.

[0043] The auxiliary filler is a compound with stability, low hygroscopicity, and sweetness (or no sweetness). The auxiliary filler not only helps to improve the taste of the composition, reduce the bitterness and irritation of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent, but also can regulate the hygroscopicity of the composition, improve the processing stability of the composition, and prevent the occurrence of problems such as premature dissolution or agglomeration of the composition.

[0044] In some embodiments, the auxiliary filler in the composition is measured in parts by mass at 13 to 20 parts. Within this range, the auxiliary filler can fully play its role in improving the taste of the composition and enhancing the stability of the composition.

[0045] In some embodiments, the secondary filler includes at least one of xylitol, mannitol, lactitol, maltitol, erythritol, isomalt, calcium phosphate, and calcium sulfate.

[0046] In some embodiments, the composition further comprises at least one of a binder, a pH adjuster, a salting agent, a sweetener, a cooling agent, and a flavor.

[0047] Among them, the adhesive can provide bonding, film-forming, thickening or gelling effects, enhance the stability of the composition structure, ensure the slow release of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition, reduce the instantaneous irritation of the natural caffeine component and the refreshing active ingredient, and improve the durability of the refreshing effect of the natural caffeine component and the refreshing active ingredient; in addition, by adjusting the mass fraction of the adhesive in the composition, the solubility of the composition in the oral cavity can also be improved, making the oral disintegration process of the composition smoother, avoiding the feeling of powder residue, and thereby improving the oral comfort of the oral product, so that the oral product provided in the embodiment of the present application can achieve a balance in taste, refreshing effect and safety, and provide an oral product with rich taste, stable release, lasting refreshing effect and high safety.

[0048] The acid-base regulator is used to adjust the pH value of the composition to prevent the composition from causing excessive irritation in the oral cavity, protect the oral mucosa, and improve the comfort of taking the oral product; as an example, the pH value of the composition can be 6 to 11.

[0049] The salty agent is used to balance the overall flavor of the composition and thus enhance the palatability of the oral preparation.

[0050] The sweetener is used to mask the bitter taste of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition, and further optimize the mouthfeel of the oral product.

[0051] The cooling agent is used to provide a cooling sensation, reduce the burning sensation caused by the active agent, and enhance the overall oral comfort of the composition.

[0052] Flavoring is used to enhance the flavor of the composition and make the oral product more attractive.

[0053] In some embodiments, the binder includes at least one of sodium carboxymethylcellulose, hydroxypropylmethylcellulose, sodium alginate, gum arabic, beta-cyclodextrin, and pectin.

[0054] In some embodiments, the acid-base adjusting agent includes at least one of sodium carbonate, sodium bicarbonate, citric acid, and lactic acid.

[0055] In some embodiments, the salting agent includes at least one of sodium chloride and potassium chloride.

[0056] In some embodiments, the sweetener includes at least one of sucralose, neotame, aspartame, acesulfame potassium, steviol glycosides, xylitol, iglete, mannitol, sorbitol, erythritol, maltitol, lactitol, saccharin sodium, montanem, sukram, agave, maple syrup, fructose, alitame, cyclamate, monk fruit sweeten, and advantame.

[0057] In some embodiments, the cooling agent includes at least one of N-ethyl-(2-isopropyl-5-methyl)cyclohexaneamide (WS-3), N,2,3-trimethyl-2-(1-methylethyl)butanamide (WS-23), N-(ethoxycarbonylmethyl)-p-menthane-3-carboxamide (WS-5), N-ethyl-2,2-diisopropylbutanamide (WS-27), N-(4-methoxyphenyl)-p-menthyl-3-carboxamide (WS-12), menthols, and isomenthol.

[0058] In some embodiments, the flavor is an edible flavor, which can be of any flavor and is not specifically limited in this application. For example, the flavor can include mint flavor, chrysanthemum flavor, citric acid flavor, fruit flavor, coffee flavor, tobacco flavor, etc.

[0059] In some embodiments, the flavor includes at least one of a natural flavor, a synthetic flavor, or a compound flavor.

[0060] In some embodiments, the composition further includes a binder, an acid-base regulator, a salting agent, a sweetener, a cooling agent and a flavor, and in the composition, measured by mass, the binder is 1 to 10 parts, the acid-base regulator is 0.5 to 5 parts, the salting agent is 0.2 to 3 parts, the sweetener is 0.2 to 2 parts, the cooling agent is 0.1 to 2 parts, and the flavor is 0.1 to 5 parts.

[0061] In some embodiments, the water content of the composition is less than or equal to 35 wt %, which not only improves the comfort of placing the oral product in the oral cavity, but also enables the release rate of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition to reach the expected effect, thereby improving the refreshing effect of the oral product.

[0062] The present application provides a method for preparing an oral product, such as Figure 1 As shown, the method includes the following steps:

[0063] Step S101: Obtain crushed natural substrate.

[0064] Step S102: mixing the filler, the active agent and the crushed material to prepare a solid mixed product.

[0065] Step S103: Granulating the solid mixed product to prepare a composition.

[0066] Step S104: packaging the composition into a permeation bag to obtain an oral product.

[0067] The method for preparing the oral product provided in the embodiments of the present application can realize the preparation of the oral product as described in any one of the above items.

[0068] In step S101, the natural base material can be mechanically crushed and sieved, and powder with a size of 15 or larger can be taken as the crushed natural base material. This can improve the uniformity of the particle size of the natural base material, and further improve the uniformity of the distribution of the natural base material in the oral product.

[0069] Among them, the natural base material is used to provide natural caffeine. As the composition in the oral product disintegrates in the oral cavity, the natural caffeine provided by the natural base material can be released in the oral cavity and absorbed by the oral mucosa, providing the user with a mild refreshing effect. The present application uses a natural base material to provide natural caffeine, and can also avoid the strong irritation problem of caffeine monomer in the related art; furthermore, the natural base material also has a natural aroma, which is conducive to enhancing the natural flavor of the oral product, improving the taste richness of the oral product, and thus improving the taste of the oral product.

[0070] In some embodiments, the natural substrate includes at least one of coffee grounds, tea grounds, and guarana powder.

[0071] In step S102, a specified weight of crushed natural substrate, filler, and active agent can be weighed and added to a mixer, and the crushed natural substrate, filler, and active agent are mixed using the mixer to obtain a solid mixed product. In the embodiment of the present application, the speed of the mixer is 200 rpm to 500 rpm, and the mixing time is 10 min to 20 min to improve the uniformity of the distribution of the components in the solid mixed product and improve the fluidity of the solid mixed product. It should be noted that the specific process parameters of the mixing can be adjusted according to actual production conditions and are not specifically limited in this application.

[0072] In some embodiments, the composition further includes an acid-base regulator, which is used to adjust the pH value of the composition, prevent the composition from causing excessive irritation in the oral cavity, protect the oral mucosa, and improve the comfort of taking the oral product; in the application scenario where the composition also includes an acid-base regulator, in step S102, the filler, acid-base regulator, active agent and crushed material can be mixed to prepare a solid mixture product.

[0073] In step S103 , a wet granulation process or a dry granulation process may be used to perform granulation based on the solid mixed product, and the granulated powder is determined as a composition; wherein the dry granulation process includes fluidized bed spray granulation.

[0074] In some embodiments, the water content of the composition is less than or equal to 35 wt %. This not only improves the comfort of placing the oral product in the oral cavity, but also enables the release rate of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition to reach the expected effect, thereby improving the refreshing effect of the oral product.

[0075] In some embodiments, in the composition prepared by step S103, the natural base material is 10 to 50 parts, the filler is 43 to 70 parts, and the active agent is 0.5 to 30 parts, measured by mass.

[0076] In some embodiments, the composition further includes an acid-base regulator. In the composition prepared in step S103, the acid-base regulator is present in an amount of 0.5 to 5 parts by mass.

[0077] In some embodiments, the filler includes a main filler and a secondary filler, and in the composition prepared by step S103, the main filler is 30 parts to 50 parts, and the secondary filler is 13 parts to 20 parts by mass.

[0078] In step S104, first, the composition prepared in step S103 is passed through a 15-mesh sieve, and the composition with more than 15 mesh is sent to a bag sealing production line. After filling and sealing in a permeation bag, boxing, and plastic sealing, an oral product is obtained. In this way, particles with too small a size and powder particles with too large a size in the composition obtained in step S103 can be removed, and the uniformity of the particle size of the composition in the oral product can be improved. In addition, the consistency of the oral product prepared in step S104 can be improved, and the problem of roughness of the oral product can be avoided.

[0079] The preparation method of the oral product provided in the embodiment of the present application utilizes granulation of the solid mixture product obtained by mixing the crushed filler, active agent and natural base material to prepare the composition, so that the composition can be uniformly formed, which is beneficial to improving the fluidity of the composition, and further improving the compressibility, disintegration and solubility of the composition, and improving the stability and uniformity of the release process of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition in the oral cavity. While providing users with a mild refreshing effect, it can also avoid the accumulation of bitterness and rough taste of the oral product, and is beneficial to reducing the bitterness and irritation of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent. In addition, the natural base material also has a natural aroma, which is beneficial to enhancing the natural flavor of the oral product, improving the taste of the oral product, and further improving the taste and safety of the oral product prepared by the embodiment of the present application.

[0080] In some embodiments, the step S103 of granulating the solid mixture product to prepare the composition comprises:

[0081] Step S1031: preparing a liquid mixture product.

[0082] Step S1032: Mix and granulate the solid mixed product and the liquid mixed product to prepare a composition.

[0083] In an embodiment of the present application, the composition further comprises at least one of a binder, a salting agent, a sweetener, a cooling agent and a flavor.

[0084] In step S1031, the specified weight of adhesive, salting agent, sweetener, cooling agent and flavor can be stirred and mixed with the solvent until they are completely dissolved to obtain a liquid mixture product, thereby improving the bonding effect of the adhesive and providing a liquid phase bonding system for the granulation process in step S103.

[0085] The solvent is used to dissolve the adhesive, salty agent, sweetener, cooling agent and flavor in the process of preparing the oral product, thereby improving the consistency and stability of the distribution of the adhesive, salty agent, sweetener, cooling agent and flavor in the composition; in some embodiments, the solvent includes at least one of pure water and ethanol.

[0086] In the application scenario where the composition also includes a binder, a salting agent, a sweetener, a cooling agent and a flavor, in the composition, measured by mass, the binder is 1 to 10 parts, the salting agent is 0.2 to 3 parts, the sweetener is 0.2 to 2 parts, the cooling agent is 0.1 to 2 parts, and the flavor is 0.1 to 5 parts.

[0087] In step S1032 , the solid mixed product and the liquid mixed product are mixed and granulated in a manner including but not limited to wet granulation and dry granulation.

[0088] In some embodiments, the step S1032 of mixing and granulating the solid mixed product and the liquid mixed product to prepare a composition comprises:

[0089] Step A11: transferring the solid mixture product to a wet granulation device, and using the wet granulation device to stir the solid mixture product at a first rotation speed.

[0090] Step A12: starting the shearing function of the wet granulation equipment, and when the shear speed of the wet granulation equipment reaches a second rotation speed, adding the liquid mixture product to the solid mixture product, so as to granulate the mixture of the solid mixture product and the liquid mixture product by the wet granulation equipment to obtain an initial granulated powder.

[0091] Step A13: drying the initial granulated powder to obtain a composition.

[0092] In the embodiment of the present application, the solid mixed product and the liquid mixed product can be wet granulated to prepare the composition through the operations corresponding to steps A11 to A13.

[0093] In step A11, the first rotational speed of stirring the solid mixture product using the wet granulation equipment is 100 rpm to 500 rpm; illustratively, the first rotational speed can be one or any two of 100 rpm, 200 rpm, 300 rpm, 400 rpm and 500 rpm.

[0094] In an embodiment of the present application, after the solid mixture product is stirred at a first speed for a first period of time using a wet granulation device in step A11, the operation corresponding to step A12 can be continued to improve the uniformity of dispersion of the components in the solid mixture product; in some embodiments, the first period of time is greater than or equal to 5 minutes.

[0095] In step A12, the shearing function of the wet granulation equipment is started, and when the shear speed of the wet granulation equipment reaches the second rotation speed, the liquid mixture product prepared in step S1031 is gradually pumped into the solid mixture product, so that the solid mixture product and the liquid mixture product are fully and evenly mixed by the shearing action of the wet granulation equipment at the second rotation speed to obtain a mixture of the solid mixture product and the liquid mixture product; thereafter, the mixture of the solid mixture product and the liquid mixture product is granulated to obtain an initial granulated powder.

[0096] The initial granulated powder is powder particles that have not been dried, and the mass proportion of the solvent in the initial granulated powder is greater than 35wt%.

[0097] The second rotational speed of the wet granulation equipment is 500 rpm to 2000 rpm; illustratively, the second rotational speed of the wet granulation equipment can be one or any two of 500 rpm, 800 rpm, 1000 rpm, 1500 rpm and 2000 rpm. Within this range, the liquid mixture product added to the solid mixture product can be fully mixed with the solid mixture product, which is beneficial to improving the uniformity of distribution of each component in the composition.

[0098] In step A12, the granulation time for granulating the mixture of the solid mixture product and the liquid mixture product by the wet granulation equipment is 10 minutes to 30 minutes; illustratively, in step A12, the granulation time for granulating the mixture of the solid mixture product and the liquid mixture product by the wet granulation equipment can be one or two range values of 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes. Within this range, the solid mixture product and the liquid mixture product can be fully mixed, the consistency of the particle size of the initial granulated powder can be improved, and the particle size distribution width of the initial granulated powder can be reduced; in addition, controlling the granulation time within this range can also allow the initial granulated powder to have sufficient time to form a certain internal structure and binding force, so that the initial granulated powder has appropriate strength and is not easily broken or pulverized in subsequent drying, screening and other processes.

[0099] After the initial granulated powder is obtained through step A12, step A13 can be performed; in step A13, the initial granulated powder can be blown dried at 50°C to 70°C to obtain a composition with a water content less than or equal to 35wt%; wherein the blown drying time can be 10min to 60min.

[0100] The preparation method of the oral product provided in the embodiment of the present application adopts a wet granulation method to prepare the composition, which can increase the bulk density of the composition and is suitable for application scenarios where the composition includes highly viscous and / or poorly soluble components.

[0101] In some embodiments, the step S1032 of mixing and granulating the solid mixed product and the liquid mixed product to prepare a composition comprises:

[0102] Step A21: transferring the solid mixture product to a fluidized bed device, and using the fluidized bed device to stir the solid mixture product at a third rotation speed.

[0103] Step A22: keeping the solid mixture product in a suspended state under the action of airflow.

[0104] Step A23: using the spray system of the fluidized bed equipment to atomize the liquid mixture product and spray it onto the surface of the solid mixture product to obtain an initial granulated powder.

[0105] Step A24: drying the initial granulated powder online to obtain a composition.

[0106] In the embodiment of the present application, the solid mixture product and the liquid mixture product can be used to perform fluidized bed granulation through the operations corresponding to steps A21 to A24 to prepare the composition.

[0107] In step A21, the third rotational speed of stirring the solid mixture product using the fluidized bed equipment is 50 rpm to 200 rpm; illustratively, the third rotational speed can be a range of one or any two of 50 rpm, 100 rpm, 150 rpm, 180 rpm and 200 rpm.

[0108] In an embodiment of the present application, after the solid mixture product is stirred at a third speed for a second period of time using a fluidized bed device in step A21, the operation corresponding to step A22 can be continued to improve the uniformity of dispersion of the components in the solid mixture product; in some embodiments, the second period of time is greater than or equal to 5 minutes, wherein the second period of time may be the same as or different from the first period of time, and the embodiment of the present application does not specifically limit this.

[0109] In step A22, a fluidized bed apparatus can be used to keep the solid mixture product in a suspended state under the action of an airflow of 0.8 m / s to 1.5 m / s, and the bed temperature of the fluidized bed apparatus can be controlled to 30° C. to 50° C. This not only allows the solid mixture product to be evenly distributed in the bed layer, avoiding local accumulation and uneven concentration, but also improves the uniformity of the liquid mixture product sprayed on the surface of the solid mixture product after atomization in step A23, which is conducive to the uniform distribution of the components in the liquid mixture product in the composition.

[0110] When the solid mixture product is kept in suspension under the action of the 0.8 m / s to 1.5 m / s airflow and the bed temperature of the fluidized bed equipment is controlled to reach 30° C. to 50° C., step A23 may be continued.

[0111] In step A23, the liquid mixture product is atomized at a pressure of 0.2 MPa to 0.4 MPa using the spray system of the fluidized bed equipment, so that the atomized product of the liquid mixture product is sprayed out in the form of tiny droplets and fully contacts the solid mixture product in a suspended state, which is beneficial to improving the mixing effect between the solid mixture product and the liquid mixture product; by controlling the spray rate of the fluidized bed spray system to 5 g / min to 50 g / min, the contact area between the atomized product of the liquid mixture product and the solid mixture product can be increased, further improving the mixing effect between the solid mixture product and the liquid mixture product.

[0112] In step A23, the granulation time is 10 minutes to 30 minutes; illustratively, in step A23, the granulation time can be a range value of one or any two of 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes. Within this range, the solid mixture product and the liquid mixture product can be fully mixed and agglomerated in the fluidized bed, so that the particle size of the generated initial granulation powder is more uniform and consistent, and the particle size distribution width of the initial granulation powder is reduced; in addition, controlling the granulation time within this range can also allow the initial granulation powder to have sufficient time to form a certain internal structure and binding force, so that the initial granulation powder has appropriate strength and is not easily broken or pulverized in subsequent drying, screening and other processes.

[0113] When the initial granulated powder is obtained by step A23, step A24 can be performed to dry the initial granulated powder online under air flow at 50°C to 80°C for 10min to 30min using a fluidized bed device to obtain a composition with a water content less than or equal to 5wt%.

[0114] The preparation method of the oral product provided in the embodiment of the present application adopts a fluidized bed granulation method to prepare the composition, which can simplify the process flow of preparing the composition, improve the uniformity of the particle size of the composition, and more accurately control the water content of the composition. It is suitable for application scenarios with high requirements on the fluidity and particle size uniformity of the composition.

[0115] The present application is further described in detail below through specific examples and comparative examples, so as to prepare an oral product by the above-mentioned method for preparing an oral product.

[0116] The following examples are only some examples of the present application and are not intended to limit the present application. In the examples and comparative examples, unless otherwise specified, the reagents and instruments used are all commercially available, and the experimental operations are carried out in accordance with the product instructions and conventional experimental specifications.

[0117] Examples 1 to 4

[0118] (1) Obtaining crushed natural substrates:

[0119] The coffee powder is mechanically crushed and sieved, and the powder with a mesh size of 15 or above is taken as the crushed coffee powder.

[0120] (2) Preparation of solid mixed product:

[0121] Specified weights of crushed coffee powder, microcrystalline cellulose, xylitol, caffeine, and sodium carbonate were weighed and added to a mixer, and the crushed coffee powder, microcrystalline cellulose, xylitol, caffeine, and sodium carbonate were mixed using the mixer to obtain a solid mixed product; wherein the mixer rotates at 300 rpm and the mixing time is 15 minutes.

[0122] (3) Preparation of liquid mixed product:

[0123] Specified weights of sodium carboxymethyl cellulose, sodium chloride, sucralose, WS-3, compound flavor, and a 50% ethanol aqueous solution are stirred and mixed until the sodium carboxymethyl cellulose, sodium chloride, sucralose, WS-3, and compound flavor are completely dissolved in the 50% ethanol aqueous solution to obtain a liquid mixture product.

[0124] (4) Preparation of composition:

[0125] First, the solid mixture product prepared in step (2) is transferred to a wet granulator, and the solid mixture product is stirred for more than 5 minutes at a first speed using the wet granulator; the first speed is 100 rpm to 500 rpm;

[0126] Then, starting the shearing function of the wet granulation equipment, and when the shearing speed of the wet granulation equipment reaches a second rotation speed, adding the liquid mixture product prepared by step (3) to the solid mixture product, so as to granulate the mixture of the solid mixture product and the liquid mixture product by the wet granulation equipment to obtain an initial granulated powder; wherein the second rotation speed is 500 rpm to 2000 rpm, and the granulation time is 10 min to 30 min;

[0127] Finally, the initial granulated powder is subjected to forced air drying at 60° C. for 10 to 60 minutes to obtain a composition having a water content of less than or equal to 35 wt %.

[0128] (5) Preparation of oral products:

[0129] First, the composition prepared in step (4) is passed through a 15-mesh sieve, and the composition with mesh size above 15 is taken and sent to a bag sealing production line. After filling and sealing into a permeation bag, boxing, and plastic sealing, it is stored to obtain an oral product.

[0130] The mass ratios of the components in the compositions of the oral products prepared in Examples 1 to 4 are shown in Table 1.

[0131] Table 1

[0132]

[0133] Comparative Example 1

[0134] A caffeine-based oral product with the product model number “Berserker Energy Pouches-Apple Danish-Caffeine Infused-100 mg Per Pouch” in the related art was used as the oral product provided in Comparative Example 1.

[0135] Detection method:

[0136] (1) Caffeine content detection: High Performance Liquid Chromatography (HPLC) was used for detection, referring to the "Determination of Caffeine in Foods" GB 5009.139-2014, using a C18 column, methanol-water or phosphate buffer as the mobile phase, and the caffeine content in the oral preparation was determined under a 273 nm UV detector to ensure the accuracy and reproducibility of the test results.

[0137] (2) pH value detection: According to GB / T 9724-2007 “General Rules for the Determination of pH Value of Chemical Reagents”, the pH value of the aqueous solution of the oral product was measured using a pH meter. The instrument was calibrated with a standard buffer solution and the measurement was performed at 25°C to ensure the accuracy and repeatability of the test.

[0138] (3) Oral epithelial cell survival rate detection: Refer to GB / T 16886.5-2017 "Biological evaluation of medical devices Part 5: In vitro cytotoxicity test", use MTT colorimetric method or CCK-8 method, after contact with oral products in the cell culture system, evaluate the survival rate by measuring the cell metabolic activity to determine the cytotoxic effect of oral products on oral epithelial cells.

[0139] (4) Caffeine dissolution test: The caffeine dissolution test was performed using the Blume Method in accordance with the Chinese Pharmacopoeia or GB / T 20031-2021 standard, using a dissolution apparatus in a simulated oral environment. The test conditions were as follows:

[0140] Medium: pH 6.8 phosphate buffer;

[0141] Temperature: 37 ± 0.5°C;

[0142] Stirring rate: 50 rpm;

[0143] Sampling time points: 1 min, 3 min, 5 min, 10 min, 20 min, 30 min, 45 min, 60 min;

[0144] Detection method: High performance liquid chromatography, detection wavelength 273nm.

[0145] Test results:

[0146] (1) Caffeine content detection: The caffeine content of the oral products prepared in Examples 1 to 4 was detected. The test results are as follows: Figure 2 As shown, refer to Figure 2The caffeine content of the oral preparation prepared by Example 3 is the highest (30.16 mg / g), which will bring a stronger refreshing effect after disintegration in the oral cavity, while the caffeine content of the oral preparations prepared by Examples 1, 2 and 4 is relatively low (below 5 mg / g), which is suitable for mild refreshing needs.

[0147] (2) pH value detection: The pH value of the oral products prepared in Examples 1 to 4 was detected. The test results are as follows: Figure 3 As shown, refer to Figure 3 The pH value of the oral preparation prepared by Example 3 is the lowest, which is 6.97. The pH value of the oral preparation prepared by Example 2 is the highest, which is 10.21. The pH values of the oral preparations prepared by Examples 1 and 4 are between 7 and 8. It can be seen that the pH of the oral preparations prepared by the examples of the present application can be maintained in the range of 6 to 11, which is beneficial to prevent the oral preparations from producing excessive irritation in the oral cavity, protect the oral mucosa, and improve the comfort of taking the oral preparations.

[0148] (3) Oral epithelial cell survival rate test: The oral products prepared by Examples 1 to 4 and the oral product provided by Comparative Example 1 were subjected to oral epithelial cell survival rate test. The test results are as follows: Figure 4 As shown in the figure, the survival rate of oral epithelial cells reflects the cytotoxicity of oral products and the irritation of oral products to cells. Figure 4 The oral epithelial cell survival rate of the oral product prepared by Example 3 was 55%, indicating that when the mass proportion of the active agent in the oral product is high (30wt%), the oral product will cause relatively greater stimulation to the cells, while the oral epithelial cell survival rate of the oral product prepared by Example 2 was the highest, which was 77%, indicating that the oral product prepared by Example 2 has higher biocompatibility; the oral products prepared by Examples 1 and 4 performed more balanced, and the cell survival rate was maintained in the range of 65% to 68%, while the oral epithelial cell survival rate of the oral product provided in Comparative Example 1 was only 51%. It can be seen that the embodiments of the present application can provide users with a mild refreshing effect and improve the safety of oral products.

[0149] (4) Caffeine dissolution test: The caffeine dissolution test was performed on the oral preparations prepared in Examples 1 to 4. The test data are shown in Table 2.

[0150] Table 2

[0151]

[0152] By performing curve fitting on the test data in Table 2, the caffeine dissolution curve of Example 1 can be obtained (e.g. Figure 5As shown), the caffeine component dissolution curve of Example 2 (as shown Figure 6 As shown), the caffeine component dissolution curve of Example 3 (as shown Figure 7 ) and the caffeine dissolution curve of Example 4 (as shown in Figure 8 shown).

[0153] Reference Figure 5 The dissolution rate of caffeine in the oral preparation prepared by Example 1 was relatively slow, with 0.3 mg / g dissolved in 1 minute, 0.9 mg / g dissolved in 3 minutes, 2.6 mg / g dissolved in 10 minutes, 3.7 mg / g dissolved in 20 minutes, 3.91 mg / g dissolved in 30 minutes, and finally the maximum dissolution amount reached 3.99 mg / g in 60 minutes, which was close to the total caffeine content in the oral preparation. Figure 5 It can be seen that the dissolution and release process of the caffeine component in the oral preparation prepared by Example 1 is relatively smooth, and can provide a relatively stable and mild refreshing effect.

[0154] Reference Figure 6 The dissolution rate of caffeine in the oral preparation prepared by Example 2 was slower than that in Example 1, with 0.05 mg / g dissolved in 1 minute, 0.35 mg / g dissolved in 5 minutes, 0.53 mg / g dissolved in 20 minutes, and the dissolution amount reached 0.55 mg / g in 60 minutes, which was close to the total caffeine content in the oral preparation. Figure 6 It can be seen that the dissolution and release process of the caffeine component in the oral preparation prepared by Example 2 is gentler and smoother, and is suitable for application scenarios that require low stimulation, a slow release process and a long duration.

[0155] Reference Figure 7 The dissolution rate of caffeine in the oral preparation prepared by Example 3 was relatively fast, with 2.02 mg / g dissolved in 1 minute, 6.52 mg / g dissolved in 3 minutes, and reaching 10.85 mg / g in 5 minutes, 19.68 mg / g dissolved in 10 minutes, 26.56 mg / g dissolved in 20 minutes, and 29.68 mg / g dissolved in 60 minutes, which was close to the total caffeine content in the oral preparation; Figure 7 It can be seen that the caffeine component in the oral preparation prepared by Example 3 has a fast dissolution and release rate, and can quickly release a large amount of caffeine, which is suitable for application scenarios that require strong instantaneous stimulation.

[0156] Reference Figure 8Compared with Examples 1 to 3, the dissolution rate of caffeine in the oral preparation prepared by Example 4 was more balanced, with 0.75 mg / g dissolved in 1 minute, 1.23 mg / g dissolved in 3 minutes, 1.69 mg / g dissolved in 5 minutes, 2.55 mg / g dissolved in 10 minutes, 2.98 mg / g dissolved in 20 minutes, and finally 4.13 mg / g dissolved in 60 minutes, which was close to the total caffeine content in the oral preparation; Figure 8 It can be seen that the dissolution and release rate of the caffeine component in the oral preparation prepared by Example 4 is moderate, which can provide a moderate degree of stimulation and is suitable for application scenarios requiring a balanced refreshing effect.

[0157] In summary, the oral preparation provided in the embodiment of the present application includes a permeable bag and a composition encapsulated in the permeable bag, wherein the composition includes a natural base material, a filler and an active agent, and the mass fraction of each component in the composition is controlled so that the ratio between the natural base material, the filler and the active agent in the composition is appropriate; wherein the natural base material can provide a natural caffeine component, and as the composition in the oral preparation disintegrates in the oral cavity, the natural caffeine provided by the natural base material can be released in the oral cavity, providing the user with a mild refreshing effect, and the active agent can provide a refreshing active ingredient, and by adjusting the mass fraction of the active agent in the composition, the refreshing effect of the natural caffeine component can be enhanced. On the basis of the above, the refreshing effect of the oral preparation is further improved by the refreshing active ingredients. In addition, the natural base material also has a natural aroma, which is beneficial to enhancing the natural flavor of the oral preparation and improving the taste of the oral preparation; the filler includes a water-insoluble material, which can improve the physical stability of the composition, improve the disintegration and solubility of the composition in the oral cavity, and make the release process of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent in the composition more uniform, which is beneficial to reduce the bitterness and irritation of the natural caffeine component provided by the natural base material and the refreshing active ingredient provided by the active agent, thereby improving the taste and safety of the oral preparation provided by the embodiment of the present application.

[0158] The above content is a further detailed description of the present application in conjunction with specific implementation methods, and the specific implementation of the present application cannot be considered to be limited to these descriptions. For ordinary technicians in the technical field to which the present application belongs, several simple deductions or substitutions can be made without departing from the concept of the present application.

Claims

1. An oral product, characterized in that: A permeable bag and a composition encapsulated in the permeable bag, the composition comprising a natural base material, a filler and an active agent, the natural base material being used to provide natural caffeine, the filler comprising a water-insoluble material; In the composition, measured by mass, the natural base material is 10 to 50 parts, the filler is 43 to 70 parts, and the active agent is 0.5 to 30 parts.

2. The oral product according to claim 1, wherein The active agent comprises at least one of caffeine monomer, theophylline, theobromine, paratheobromine, quercetin, ephedrine, pseudoephedrine, modafinil and methylphenidate; and / or, The natural base material includes at least one of coffee powder, tea powder and guarana powder.

3. The oral product according to claim 1, characterized in that The filler includes a main filler and an auxiliary filler; in the composition, measured by mass, the main filler accounts for 30 to 50 parts, and the auxiliary filler accounts for 13 to 20 parts.

4. The oral product according to claim 3, characterized in that The main filler comprises at least one of microcrystalline cellulose, sodium carboxymethyl cellulose, hypromellose, ethyl cellulose, micropowdered silica gel and modified starch; and / or, The auxiliary filler includes at least one of xylitol, mannitol, lactitol, maltitol, erythritol, isomalt, calcium phosphate and calcium sulfate.

5. The oral product according to claim 1, wherein The composition further comprises at least one of a binder, a pH regulator, a salting agent, a sweetener, a cooling agent and a flavor.

6. The oral product according to claim 5, characterized in that The binder comprises at least one of sodium carboxymethylcellulose, hydroxypropylmethylcellulose, sodium alginate, gum arabic, β-cyclodextrin and pectin; and / or, The acid-base regulator includes at least one of sodium carbonate, sodium bicarbonate, citric acid and lactic acid; and / or, The salting agent includes at least one of sodium chloride and potassium chloride; and / or, The sweetener comprises at least one of sucralose, neotame, aspartame, acesulfame potassium, steviol glycosides, xylitol, ignol, mannitol, sorbitol, erythritol, maltitol, lactitol, saccharin sodium, mongoose, sukram, agave sugar, maple syrup, fructose, alitame, cyclamate, monk fruit sweetener and glycoside advantam; and / or, The cooling agent includes at least one of N-ethyl-(2-isopropyl-5-methyl)cyclohexaneamide, N,2,3-trimethyl-2-(1-methylethyl)butyramide, N-(ethoxycarbonylmethyl)-p-menthane-3-carboxamide, N-ethyl-2,2-diisopropylbutyramide, N-(4-methoxyphenyl)-p-menthyl-3-carboxamide, menthols and isomenthol.

7. The oral product according to claim 1, characterized in that The composition further comprises a binder, an acid-base regulator, a salting agent, a sweetener, a cooling agent and a flavor; In the composition, measured by mass, the binder is 1 to 10 parts, the acid-base regulator is 0.5 to 5 parts, the salting agent is 0.2 to 3 parts, the sweetener is 0.2 to 2 parts, the cooling agent is 0.1 to 2 parts, and the flavor is 0.1 to 5 parts.

8. The oral product according to any one of claims 1 to 7, characterized in that The water content of the composition is less than or equal to 35 wt %.

9. A method for preparing an oral product, characterized in that: The method comprises: Obtaining a crushed product of a natural substrate, wherein the natural substrate is used to provide natural caffeine; Mixing a filler, an active agent, and the crushed material to prepare a solid mixed product, wherein the filler comprises a water-insoluble material; Granulating the solid mixed product to prepare a composition, wherein, in the composition, the natural base material is 10 to 50 parts, the filler is 43 to 70 parts, and the active agent is 0.5 to 30 parts by weight; The composition is packaged into an osmotic bag to obtain an oral product.

10. The method according to claim 9, characterized in that The method of preparing a composition by granulating the solid mixed product comprises: preparing a liquid mixed product, wherein the liquid mixed product comprises at least one of a binder, a salting agent, a sweetener, a cooling agent, and a flavor; The solid mixed product and the liquid mixed product are mixed and granulated to prepare a composition.

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