Buccal product and preparation method thereof

Abstract

The invention provides a buccal product and a preparation method thereof, and relates to the field of buccal products. The preparation method of the buccal product comprises the following steps: mixing an active substance with a porous carrier, so that the porous carrier adsorbs the active substance to obtain an active component load; in the process of preparing the active component load and / or after the active component load is obtained, auxiliary materials are added and mixed, and the buccal product loaded with the active substances is obtained. The form of the active substance comprises a solid state or a liquid state, and when the active substance is in the solid state, the ratio of the average particle size of the active substance to the average particle size of the porous carrier is less than or equal to 1: 2. By adding the porous carrier with a porous structure and high adsorbability, active substances including nicotine can be adsorbed, and effective fixation of the active substances is realized. In the preparation process, a heating process is not adopted, so that the volatilization loss of active substances is remarkably reduced, and the content and the stability of effective components of the product are improved.

Description

Technical Field

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

[0002] In the current tobacco substitute market, oral products, as an emerging product, are gradually gaining attention because they can provide users with an alternative way to ingest tobacco active ingredients (such as nicotine).

[0003] Oral preparations are mainly divided into two categories: dry granules and wet granules. When producing dry granule products, common processes include wet granulation plus fluidized bed drying process or fluidized bed granulation process. However, these processes have significant problems in the drying process of active ingredients: active ingredients such as nicotine will volatilize in large quantities due to heat, and the volatilization loss can reach more than 40%, which not only leads to a significant reduction in the effective ingredients of the product, but also increases production costs. In addition, since active ingredients such as nicotine are highly irritating and toxic, during the production process, workers often suffer from discomfort reactions, such as irritation to the eyes, pain, coughing, etc., which not only affects the health of the workers, but also reduces production efficiency. Although the existing technology alleviates these problems by strengthening workshop exhaust and requiring workers to wear protective masks, these methods cannot fundamentally solve the volatilization of active ingredients and potential threats to personnel health. Summary of the invention

[0004] The purpose of the present application is to provide an oral product and a preparation method thereof to solve the above-mentioned problems.

[0005] A method for preparing an oral product, comprising: mixing an active substance with a porous carrier, allowing the porous carrier to adsorb the active substance to obtain an active ingredient loaded substance;

[0006] During the process of preparing the active ingredient loading material and / or after obtaining the active ingredient loading material, adding auxiliary materials and mixing to obtain an oral product loaded with the active substance;

[0007] The active substance may be in a solid state or a liquid state. When the active substance is in a solid state, the ratio of the average particle size of the active substance to the average particle size of the porous carrier is less than or equal to 1:2.

[0008] In some embodiments, the average particle size of the active material is less than or equal to 100 μm;

[0009] and / or, the average particle size of the porous carrier is greater than or equal to 100 μm;

[0010] and / or, the difference between the average particle size of the porous carrier and the average particle size of the auxiliary material is greater than or equal to 50 μm;

[0011] And / or, the porosity of the porous carrier is 50% - 90%, and the pore size of the porous carrier is 10nm - 500nm.

[0012] In some embodiments, preparing the active ingredient loading includes: preliminarily mixing the active substance with a part of the porous carrier to obtain a preliminary mixture, and then secondarily mixing the preliminary mixture with the remaining porous carrier.

[0013] In some embodiments, when performing the preliminary mixing, the mass ratio of the active substance to the porous carrier is 1:5 - 1:10;

[0014] And / or, the excipient includes a binder, and the method further includes: adding the binder when performing the secondary mixing to mix the preliminary mixture with the remaining porous carrier and the binder.

[0015] In some embodiments, the time of the preliminary mixing is 3 - 60 min, and the rate of the preliminary mixing is 10 - 15 rpm;

[0016] And / or, the time of the secondary mixing is 10 - 30 min, and the rate of the secondary mixing is 10 - 15 rpm.

[0017] In some embodiments, the active substance includes nicotine compounds, and the nicotine compounds include at least one of nicotine and nicotine derivatives;

[0018] And / or, the porous carrier includes at least one of microcrystalline cellulose, porous lactose, and porous mannitol.

[0019] In some embodiments, the binder includes at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, and povidone;

[0020] And / or, the excipient further includes at least one of a lubricant, a sweetener, a flavor, and a pH regulator;

[0021] After obtaining the active ingredient loading, the method further includes: mixing the active ingredient loading with at least one of a lubricant, a sweetener, a flavor, and a pH regulator to obtain an oral preparation.

[0022] In some embodiments, the sweetener includes at least one of xylitol, sorbitol, mannitol, erythritol, lactitol, maltitol, isomaltulose, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, sodium cyclamate, alitame, stevioside, arabinitol, and mogroside;

[0023] And / or, the pH regulator includes at least one of citric acid and sodium bicarbonate;

[0024] And / or, the lubricant includes at least one of talcum powder, colloidal silicon dioxide, and magnesium stearate;

[0025] And / or, the content of the active substance is 1 to 20 parts by weight, the content of the porous carrier is 50 to 99 parts by weight, and the content of the binder is 1 to 3 parts by weight;

[0026] And / or, the content of the lubricant is 0.5 to 3 parts by weight;

[0027] And / or, the content of the sweetener is 0.1 to 3 parts by weight;

[0028] And / or, the content of the essence is 0.1 to 20 parts by weight;

[0029] And / or, the content of the pH regulator is 0.1 to 5 parts by weight.

[0030] The present application also provides an orally held product, which is prepared by the preparation method of the orally held product described above.

[0031] Compared with the prior art, the beneficial effects of the present application include:

[0032] The present application proposes a novel preparation method for an orally held product. By adding a porous carrier with a porous structure and high adsorption performance, the method can adsorb active substances including nicotine, achieving effective fixation of the active substances.

[0033] Compared with the existing methods, the present application does not adopt a heating process during the preparation process, significantly reducing the volatilization loss of the active substances, thereby increasing the content and stability of the active ingredients in the product. Moreover, the preparation process of the present application is simple, without the need for complex heating and drying steps, reducing the production difficulty and cost, and improving the production efficiency. In addition, the method of the present application can reduce the volatilization amount of the active substances, thereby improving the air environment in the production workshop and being beneficial to ensuring the physical health of the staff. Description of the Drawings

[0034] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings required for the embodiments. It should be understood that the following drawings only show some embodiments of the present application and should not be regarded as limiting the scope of the present application.

[0035] Figure 1 It is a comparison chart of the dissolution curves of the orally held products of Examples 1 - 3 and Comparative Example 1. Detailed Embodiments

[0036] As used herein, the terms "comprising", "including", "having", "containing" or any other variation thereof are intended to cover non-exclusive inclusion. For example, a composition, step, method, article or apparatus containing the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article or apparatus.

[0037] When an equivalent, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper preferred values and lower preferred values, this should be understood to specifically disclose all ranges formed by any pairing of any range upper limit or preferred value with any range lower limit or preferred value, regardless of whether the ranges are separately disclosed. For example, when the range "1 to 5" is disclosed, the described range should be interpreted to include ranges "1 to 4", "1 to 3", "1 to 2", "1 to 2 and 4 to 5", "1 to 3 and 5", etc. When a numerical range is described herein, unless otherwise stated, the range is intended to include its end values and all integers and fractions within the range.

[0038] In these examples, unless otherwise specified, the parts and percentages are by mass.

[0039] "Parts by mass" refers to the basic measurement unit representing the mass ratio relationship of multiple components. 1 part can represent any unit mass, such as 1 g or 2.689 g, etc. If we say that the mass part of component A is a parts and the mass part of component B is b parts, it means the mass ratio of component A to component B is a:b. Or, it means the mass of component A is aK and the mass of component B is bK (K is any number representing a multiple factor). It should not be misunderstood that the sum of the mass parts of all components is not limited to 100 parts.

[0040] "And / or" is used to indicate that one or both of the stated circumstances may occur. For example, A and / or B includes (A and B) and (A or B).

[0041] Currently, the oral products on the market include dry granule and wet granule products. Among them, the dry granule products adopt the wet granulation plus fluidized bed drying process or the fluidized bed granulation process. During the drying process, there will be volatilization of the active ingredient, and the loss can reach more than 40%. Moreover, the volatilization of the active ingredient will also cause discomfort reactions in production personnel, such as stinging eyes, coughing and other symptoms.

[0042] To improve the above technical problems, the present application provides a method for preparing an oral product, comprising: mixing an active substance with a porous carrier so that the porous carrier adsorbs the active substance to obtain an active ingredient loading.

[0043] During the preparation of the active ingredient load and / or after obtaining the active ingredient load, excipients are added and mixed to obtain an orally held product loaded with the active substance;

[0044] The form of the active substance includes solid or liquid. When the active substance is solid, the ratio of the average particle size of the active substance to the average particle size of the porous carrier is less than or equal to 1:2.

[0045] In some embodiments, the preparation method of the present application does not require heating.

[0046] The present application uses a porous carrier to adsorb the active substance. When the active substance is solid, the average particle size of the porous carrier is larger than that of the active substance, and the surface of the carrier has a loose and porous structure, which can firmly adsorb the active substance. In the process of preparing the orally held product, the present application does not adopt a temperature-raising process, and the volatilization amount of the active ingredient is small. Moreover, the present application also has the advantage of simple process.

[0047] In some embodiments, the average particle size of the active substance is less than or equal to 100 μm;

[0048] In some embodiments, the average particle size of the porous carrier is greater than or equal to 100 μm.

[0049] In some embodiments, the difference between the average particle size of the porous carrier and the average particle size of the excipient is greater than or equal to 50 μm.

[0050] In some embodiments, the porosity of the porous carrier is 50% - 90%, and the pore size of the porous carrier is 10 nm - 500 nm.

[0051] In some embodiments, the preparation of the active ingredient load includes: preliminarily mixing the active substance with a part of the porous carrier to obtain a preliminary mixture, and then secondarily mixing the preliminary mixture with the remaining porous carrier.

[0052] In some embodiments, when performing the preliminary mixing, the mass ratio of the active substance to the porous carrier is 1:5 - 1:10;

[0053] In some embodiments, the excipient includes a binder, and the method further includes: adding the binder during the secondary mixing to mix the preliminary mixture with the remaining porous carrier and the binder.

[0054] In some embodiments, the time for the preliminary mixing is 3 - 60 min, and the rate of the preliminary mixing is 10 - 15 rpm;

[0055] In some embodiments, the time for the secondary mixing is 10 - 30 min, and the rate of the secondary mixing is 10 - 15 rpm.

[0056] In some embodiments, the active substance includes nicotine compounds, and the nicotine compounds include at least one of nicotine and nicotine derivatives;

[0057] Furthermore, nicotine includes at least one of natural nicotine and synthetic nicotine;

[0058] Nicotine derivatives include one or several of nicotine salts, nicotine in a matrix such as a sugar matrix or an organometallic complex, nicotine-resin combinations, nicotine inclusion complexes, 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 ditartrate, nicotine tartrate dihydrate, nicotine ditartrate dihydrate, nicotine sulfate, nicotine zinc chloride, nicotine benzoate, etc. Nicotine derivatives also include nicotine with substituents, such as hexamethyl nicotine, hexamethyl nicotine lactate, hexamethyl nicotine malate, hexamethyl nicotine salicylate, hexamethyl nicotine cyclodextrin inclusion complex, hexamethyl nicotine hydrochloride, hexamethyl nicotine dihydrochloride, hexamethyl nicotine tartrate, hexamethyl nicotine tartrate dihydrate, hexamethyl nicotine sulfate, hexamethyl nicotine zinc chloride, hexamethyl nicotine benzoate, and one or more mixtures thereof.

[0059] In some embodiments, the porous carrier includes at least one of microcrystalline cellulose, porous lactose, and porous mannitol.

[0060] Exemplarily, the models of microcrystalline cellulose include microcrystalline cellulose 102, microcrystalline cellulose 112, and microcrystalline cellulose 200, the models of porous lactose include lactose 80 and lactose 100, and the models of porous mannitol include mannitol 100.

[0061] In some embodiments, the binder includes at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, and polyvinylpyrrolidone;

[0062] In some embodiments, the excipients further include at least one of a lubricant, a sweetener, a flavor, and a pH regulator;

[0063] After obtaining the active ingredient load, the method of the present application further includes: mixing the active ingredient load with at least one of a lubricant, a sweetener, a flavor, and a pH regulator to obtain an oral product.

[0064] In some embodiments, the sweetener includes at least one of xylitol, sorbitol, mannitol, erythritol, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, sodium cyclamate, alitame, stevioside, arabitol, mogroside;

[0065] In some embodiments, the pH regulator includes at least one of citric acid and sodium bicarbonate, and the pH value can be controlled between 4 and 9 by adjusting the ratio.

[0066] In some embodiments, the lubricant includes at least one of talc, colloidal silica, and magnesium stearate;

[0067] In some embodiments, the content of the active substance is 1 to 20 parts by weight, the content of the porous carrier is 50 to 99 parts by weight, and the content of the binder is 1 to 3 parts by weight;

[0068] Exemplarily, the content of the active substance can be 1 part by weight, 5 parts by weight, 10 parts by weight, 15 parts by weight, 20 parts by weight, or any value between 1 and 20 parts by weight; the content of the porous carrier can be 50 parts by weight, 55 parts by weight, 60 parts by weight, 65 parts by weight, 70 parts by weight, 75 parts by weight, 80 parts by weight, 85 parts by weight, 90 parts by weight, 95 parts by weight, 99 parts by weight, or any value between 50 and 99 parts by weight; the content of the binder can be 1 part by weight, 2 parts by weight, 3 parts by weight, or any value between 1 and 3 parts by weight.

[0069] In some embodiments, the content of the lubricant is 0.5 to 3 parts by weight;

[0070] Exemplarily, the content of the lubricant can be 0.5 part by weight, 1 part by weight, 2 part by weight, 3 part by weight, or any value between 0.5 and 3 parts by weight.

[0071] In some embodiments, the content of the sweetener is 0.1 to 3 parts by weight;

[0072] In some embodiments, the content of the essence is 0.1 to 20 parts by weight;

[0073] In some embodiments, the content of the pH regulator is 0.1 to 5 parts by weight.

[0074] The present application also provides an oral product, which is prepared by the preparation method of the oral product described above.

[0075] The implementation scheme of the present application will be described in detail below in conjunction with specific embodiments. However, those skilled in the art will understand that the following embodiments are only used to illustrate the present application and should not be regarded as limiting the scope of the present application. For those conditions not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. For reagents or instruments not specified by the manufacturer, they are all conventional products that can be obtained through commercial purchase.

[0076] I. Preparation of Oral Products

[0077] Example 1

[0078] Example 1 provides an oral product, including a porous carrier, an active substance and excipients. The active substance is nicotine (liquid state), and the excipients include a binder, a lubricant, a sweetener, a flavoring agent, and a pH regulator. Among them, the average particle size of the porous carrier is 190 - 300 μm. The formula of the oral product in Example 1 is shown in Table 1 below.

[0079] Table 1 Formula Table of the Oral Product in Example 1

[0080]

[0081] Example 1 also provides a preparation method of an oral product, including:

[0082] (1) Weigh each component according to the formula ratio shown in Table 1. Mix the active substance with a part of the porous carrier so that the active substance is adsorbed onto the porous carrier. Control the mass ratio of the active ingredient to the porous carrier to be 1:5, pass through a 40-mesh sieve three times, mix for 5 minutes, and the mixing rate is 10 - 15 rpm for later use;

[0083] (2) Then mix the material obtained in step (1) with the remaining porous carrier and the binder in an upper cone or three-dimensional mixer. The mixing time is 10 - 30 minutes, and the mixing rate is 10 - 15 rpm for later use;

[0084] (3) Then mix the sweetener and the pH regulator with the material obtained in step (2). The mixing time is 10 - 30 minutes, and the mixing rate is 10 - 15 rpm for later use;

[0085] (4) Mix the material obtained in step (3) with the lubricant and the flavoring agent. The mixing time is 3 minutes, and the mixing rate is 10 - 15 rpm for later use;

[0086] (5) Load the material obtained in step (4) into a fiber bag according to a filling amount of 400 - 500 mg to obtain the oral product.

[0087] Example 2

[0088] Prepare the buccal product according to the preparation method of Example 1. Among them, in Example 2, the average particle size of the porous carrier is 380-530 μm, the average particle size of the active substance is 50 μm, the average particle size of the sweetener is 100-300 μm. The formula of the buccal product in Example 2 is shown in Table 2 for details.

[0089] Table 2 Formula Table of the Buccal Product in Example 2

[0090]

[0091] Example 3

[0092] Prepare the buccal product according to the preparation method of Example 1. Among them, in Example 3, the average particle size of the porous carrier is 380-530 μm, the average particle size of the active substance is 100 μm, the average particle size of the sweetener is 100-300 μm. The formula of the buccal product in Example 3 is shown in Table 3 for details.

[0093] Table 3 Formula Table of the Buccal Product in Example 3

[0094]

[0095] Comparative Example 1

[0096] Prepare the buccal product by the traditional method in Comparative Example 1. The formula table of the buccal product in Comparative Example 1 is shown in Table 4.

[0097] Table 4 Formula Table of the Buccal Product in Comparative Example 1

[0098]

[0099] Use each component in Table 4 as raw materials to prepare the buccal product. Among them, the average particle size of the porous carrier is 190-300 μm, and the average particle size of the sweetener is 200 μm.

[0100] The method for preparing the buccal product in Comparative Example 1 includes the following steps:

[0101] (1) Pour nicotine, hydroxypropyl cellulose, acesulfame potassium, essence and sodium bicarbonate into a beaker containing an appropriate amount of purified water, and stir to dissolve.

[0102] (2) Add microcrystalline cellulose 102 into the fluidized bed, and spray the solution in (1) onto the surface of microcrystalline cellulose through a spray gun.

[0103] Fluidized bed parameters: Inlet air temperature: 40-50 °C; Inlet air volume: 40-60 m 3 / h; Liquid spraying rate: 3-10 g / min.

[0104] (3) Dry the particles completed by fluidized granulation, and control the moisture content ≤ 5%.

[0105] (4) Pass through a 20-mesh sieve.

[0106] (5) Mix the materials prepared by the fluidized bed with mannitol for 30 minutes.

[0107] (6) Add magnesium stearate to (5) and mix for 3 minutes.

[0108] (7) Bagging, controlling the filling amount to be 400 mg - 500 mg per bag.

[0109] II. Performance Testing of Buccal Products

[0110] 1. Determination of the Content of Active Ingredients in Buccal Products

[0111] Use high performance liquid chromatography to detect the buccal products of Examples 1 - 3 and Comparative Example 1, and obtain the content of active ingredients in the buccal products. The test results are shown in Table 5 below.

[0112] Table 5 Comparison Table of the Content of Active Ingredients in Buccal Products of Examples 1 - 3 and Comparative Example 1

[0113] Project Example 1 Example 2 Example 3 Comparative Example 1 Nicotine content 99.8％ 99.9％ 99.8％ 56.1％

[0114] It can be seen from Table 5 that the content of active ingredients in the buccal products of Examples 1 - 3 is significantly higher than that in the buccal product of Comparative Example 1, indicating that compared with the traditional method, the content of active substances in the buccal products prepared by the method of this application is higher, that is, the loss rate of active ingredients in the preparation method of this application is lower.

[0115] 2. Determine the dissolution curve of the buccal product

[0116] Determine the dissolution curve of the buccal products prepared in Examples 1 - 3 and Comparative Example 1.

[0117] Equipment: Dissolution tester - paddle method;

[0118] Samples: Buccal product of Example 1, buccal product of Example 2, buccal product of Example 3, buccal product of Comparative Example 1;

[0119] Dissolution medium: pH6.8, 900 ml phosphate medium;

[0120] Sampling points: 0.5 min, 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min;

[0121] Test conditions: Heating temperature 37°C, rotation speed 50 r / min;

[0122] Analysis method: Use a high performance liquid chromatograph to detect the nicotine content;

[0123] The test results are shown in Figure 1 and Table 6 below.

[0124] Table 6 Comparison Table of Dissolution Effects of Oral Products in Examples 1-3 and Comparative Example 1

[0125]

[0126] Among them, the dissolution degree of the samples in Table 6 refers to the percentage of the nicotine content released into the dissolution medium in the theoretical feeding amount.

[0127] It can be seen from Figure 1 and Table 6 that the dissolution rate of the active ingredients in the oral products of Examples 1-3 is significantly higher than that of Comparative Example 1.

[0128] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than limiting them; although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.

[0129] In addition, those skilled in the art can understand that although some of the embodiments herein include some features included in other embodiments rather than other features, the combination of the features of different embodiments means that it is within the scope of the present application and forms different embodiments. For example, in the claims above, any one of the claimed embodiments can be used in any combination. The information disclosed in this background art section is only intended to deepen the understanding of the overall background art of the present application, and should not be regarded as admitting or implying in any form that this information constitutes the prior art known to those skilled in the art.

Claims

1. A method for preparing an oral product, characterized in that, Comprising: Mixing an active substance with a porous carrier to enable the porous carrier to adsorb the active substance, thereby obtaining an active ingredient-loaded product; Adding excipients during the process of preparing the active ingredient-loaded product and / or after obtaining the active ingredient-loaded product, and mixing to obtain an oral product loaded with the active substance; The form of the active substance includes solid or liquid. When the active substance is solid, the ratio of the average particle size of the active substance to the average particle size of the porous carrier is less than or equal to 1:

2.

2. The preparation method of the oral product according to claim 1, characterized in that, The average particle size of the active substance is less than or equal to 100 μm; And / or, the average particle size of the porous carrier is greater than or equal to 100 μm; And / or, the difference between the average particle size of the porous carrier and the average particle size of the excipients is greater than or equal to 50 μm; And / or, the porosity of the porous carrier is 50% - 90%, and the pore size of the porous carrier is 10 nm - 500 nm.

3. The preparation method of the oral product according to claim 1, characterized in that, Preparing the active ingredient-loaded product includes: preliminarily mixing the active substance with a part of the porous carrier to obtain a preliminary mixture, and then performing secondary mixing of the preliminary mixture with the remaining porous carrier.

4. The preparation method of the oral product according to claim 3, wherein When performing the preliminary mixing, the mass ratio of the active substance to the porous carrier is 1:5 - 1:

10.

5. The preparation method of the oral product according to claim 3, characterized in that, The excipients include a binder, and the method further includes: adding the binder during the secondary mixing to mix the preliminary mixture with the remaining porous carrier and the binder.

6. The preparation method of the oral product according to any one of claims 3-5, characterized in that, The time of the preliminary mixing is 3 - 60 min, and the rate of the preliminary mixing is 10 - 15 rpm; And / or, the time of the secondary mixing is 10 - 30 min, and the rate of the secondary mixing is 10 - 15 rpm.

7. The preparation method of the oral product according to claim 1, characterized in that, The active substance includes nicotine compounds, and the nicotine compounds include at least one of nicotine and nicotine derivatives; And / or, the porous carrier includes at least one of microcrystalline cellulose, porous lactose, and porous mannitol.

8. The manufacturing method of the oral product according to claim 5, characterized in that, The binder includes at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, and polyvinylpyrrolidone; And / or, the excipients further include at least one of a lubricant, a sweetener, a flavor, and a pH regulator.

9. The method for preparing the oral product according to claim 8, characterized in that, The sweetener includes at least one of xylitol, sorbitol, mannitol, erythritol, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, sodium cyclamate, alitame, stevioside, arabinitol, and mogroside; And / or, the pH regulator includes at least one of citric acid and sodium bicarbonate; And / or, the lubricant includes at least one of talc, colloidal silica, and magnesium stearate; And / or, the content of the active substance is 1 - 20 parts by weight, the content of the porous carrier is 50 - 99 parts by weight, and the content of the binder is 1 - 3 parts by weight; And / or, the content of the lubricant is 0.5 - 3 parts by weight; And / or, the content of the sweetener is 0.1 - 3 parts by weight; And / or, the content of the flavor is 0.1 - 20 parts by weight; And / or, the content of the pH regulator is 0.1 to 5 parts by weight.

10. An oral product, characterized in that, The buccal product is prepared by the preparation method of the buccal product according to any one of claims 1-9.

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