Buccal product and preparation method thereof

Abstract

The invention discloses a buccal product and a preparation method thereof, and belongs to the technical field of smokeless tobacco products. The buccal product comprises a composition, and the composition comprises the following components in parts by mass: 1-10 parts of a nicotine active component, 20-40 parts of a medicinal component, 20-40 parts of a slow-release component, 0.5-10 parts of a binder, 0.1-10 parts of a flavoring agent, 0.1-5 parts of a sweetening agent and 0.1-5 parts of an acid-base regulator, wherein the medicinal components comprise anti-oxidation Chinese herbal medicines, the anti-oxidation Chinese herbal medicines are powdery, and the particle size of the anti-oxidation Chinese herbal medicines is 50-300 [mu] m. According to the buccal product provided by the invention, on the basis of selection of the raw material components and the proportional relation among the raw material components, the risk that the nicotine active component is oxidized in the storage of the buccal product can be reduced, stable and continuous release of the nicotine active component is facilitated, and the release speed of the nicotine active component can be stably controlled.

Description

Technical Field

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

[0002] Oral products are smokeless products containing nicotine. Oral products usually do not need to be burned. Instead, they are placed in the mouth so that nicotine is absorbed by the oral mucosa, providing consumers with a certain nicotine satisfaction through oral administration. Existing oral products are prone to oxidation and discoloration, and their dissolution rate in the mouth varies, resulting in unstable nicotine release rate, affecting the user experience. Summary of the invention

[0003] The present application provides an oral product and a preparation method thereof, which can solve the technical problems that the oral product is easily oxidized and discolored and the nicotine release rate is unstable.

[0004] In order to solve the above technical problems, the present application provides an oral product on the one hand, which includes a composition, which includes, by weight: 1-10 parts of nicotine active ingredient, 20-40 parts of medicinal ingredients, 20-40 parts of sustained-release ingredients, 0.5-10 parts of binder, 0.1-10 parts of flavoring agent, 0.1-5 parts of sweetener, and 0.1-5 parts of acid-base regulator; wherein the medicinal ingredients include antioxidant Chinese herbal medicine, the antioxidant Chinese herbal medicine is in powder form, and the particle size of the antioxidant Chinese herbal medicine is 50μm-300μm.

[0005] In one embodiment, the antioxidant Chinese herbal medicine includes at least one of honeysuckle, dandelion, perilla, aloe, chrysanthemum, mint, liquorice, forsythia, scutellaria and isatis root.

[0006] In one embodiment, the sustained-release component includes at least one of microcrystalline cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, sodium hydroxymethyl cellulose, polyvinyl pyrrolidone, sodium alginate, methylcellulose, hydroxyethyl cellulose, cellulose acetate phthalate, xylitol, mannitol, sorbitol, xylitol, erythritol, maltitol, lactitol, starch and sucrose; and / or, the nicotine active ingredient includes at least one of nicotine salt, sodium nicotinate, potassium nicotinate, nicotine and hexamethyl nicotine; and / or, the binder includes The invention relates to a method for preparing the present invention which comprises the following: the method comprises: comprising: providing a sweetener comprising at least one of povidone, hydroxypropyl methylcellulose and sodium carboxymethyl cellulose; and / or the sweetener comprises at least one of stevia, xylitol, ignol, aspartame, mannitol, sorbitol, erythritol, maltitol, lactitol, saccharin sodium, mongoose, sukram, agave sugar, maple syrup, fructose, neotame, alitame, aspartame, cyclamate, acesulfame potassium, steviol glycosides, monk fruit sweetener and adventitone; and / or the acid-base regulator comprises at least one of sodium carbonate, sodium bicarbonate, citric acid and lactic acid.

[0007] In one embodiment, the particle size of the oral preparation is 50 μm-500 μm or 100 μm-1000 μm.

[0008] In one embodiment, the oral preparation further comprises a osmotic bag, wherein the osmotic bag is used to package the composition.

[0009] On the other hand, the present application provides a method for preparing an oral product, which comprises: obtaining an antioxidant Chinese herbal medicine in powder form with a particle size of 50 μm-300 μm; mixing the raw materials to obtain a mixture, wherein the raw materials comprise, by weight, 20-40 parts of a sustained-release component, 1-10 parts of a nicotine active ingredient, 20-40 parts of an antioxidant Chinese herbal medicine, 0.5-10 parts of a binder, 0.1-10 parts of a flavoring agent, 0.1-5 parts of a sweetener, and 0.1-5 parts of an acid-base regulator; adding a solvent to the mixture to obtain a mixed solution, wherein the solvent comprises 10-20 parts by weight; granulating the mixed solution to obtain solid particles; and crushing the solid particles and sieving them to obtain the oral product.

[0010] In one embodiment, obtaining antioxidant Chinese herbal medicine in powder form with a particle size of 50 μm-300 μm includes: disinfecting and sterilizing the antioxidant Chinese herbal medicine; drying the antioxidant Chinese herbal medicine; and grinding the antioxidant Chinese herbal medicine so that the particle size of the antioxidant Chinese herbal medicine is 50 μm-300 μm.

[0011] In one embodiment, the disinfection and sterilization is steam disinfection, the temperature of steam disinfection is 110℃-130℃, and the time is 15min-20min; and / or the temperature of drying the antioxidant Chinese herbal medicine is 50℃-70℃, and the moisture content of the antioxidant Chinese herbal medicine after drying is less than or equal to 5%.

[0012] In one embodiment, the granulation process includes a fluidized granulation process or a wet granulation process.

[0013] In one embodiment, the time when 80% of the nicotine active ingredient in the oral product is released is taken as the peak time, and the peak time of the oral product is 5 min-20 min, or the peak time of the oral product is 20 min-35 min.

[0014] The oral preparation provided by the present application is based on the selection of raw material components and the proportional relationship between the raw material components, and the antioxidant Chinese herbal medicine is in powder form, and the particle size of the antioxidant Chinese herbal medicine is 50μm-300μm, so that the antioxidant Chinese herbal medicine can reduce the risk of oxidation of the nicotine active ingredient during storage of the oral preparation; and because the powdered antioxidant Chinese herbal medicine is in a solid state, the release rate of the active ingredient is more stable, and by controlling the particle size of the antioxidant Chinese herbal medicine, the release rate of the active ingredient in the antioxidant Chinese herbal medicine meets the requirements, which is beneficial to the stable and continuous release of the nicotine active ingredient, and the release rate of the nicotine active ingredient can be stably controlled. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0016] Figure 1 It is a schematic diagram of a process of an embodiment of a method for preparing an oral product provided by the present application;

[0017] Figure 2 It is a schematic flow chart of an embodiment of a method for preparing an antioxidant Chinese herbal medicine provided by the present application;

[0018] Figure 3 is a comparison chart of the dissolution test results of Example A and Comparative Example a;

[0019] Figure 4 is a comparison chart of the dissolution test results of Example A and Comparative Example B;

[0020] Figure 5 is a comparison chart of the dissolution test results of Example A and Comparative Example C;

[0021] Figure 6 is a comparison chart of the dissolution test results of Example A and Comparative Example d;

[0022] Figure 7 is a comparison chart of the dissolution test results of Example A and Comparative Example e;

[0023] Figure 8 2 is a comparison chart of the dissolution test results of Examples AD. DETAILED DESCRIPTION

[0024] The present application is further described in detail below in conjunction with the accompanying drawings and examples. It is particularly noted that the following examples are only used to illustrate the present application, but are not intended to limit the scope of the present application. Similarly, the following examples are only some embodiments of the present application rather than all embodiments, and all other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of the present application.

[0025] In the description of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise clearly and specifically limited. The terms "first", "second", and "third" in the embodiments of the present application are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first", "second", and "third" can explicitly or implicitly include at least one of the features. In the embodiments of the present application, all directional indications (such as up, down, left, right, front, back...) are only used to explain the relative position relationship, movement, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication also changes accordingly. The terms "including" and "having" in the embodiments of the present application and any of their variations are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but optionally also includes steps or units that are not listed, or optionally also includes other steps or components inherent to these processes, methods, products, or devices.

[0026] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0027] The present application provides an oral product. The oral product includes a composition, which includes, by weight, 1-10 parts of nicotine active ingredients, 20-40 parts of medicinal ingredients, 20-40 parts of sustained-release ingredients, 0.5-10 parts of binders, 0.1-10 parts of flavoring agents, 0.1-5 parts of sweeteners, and 0.1-5 parts of acid-base regulators. The nicotine active ingredient may include nicotine or a nicotine derivative, which is used to provide nicotine or a substance with a similar effect to nicotine. When the oral product is placed in the oral cavity, the nicotine active ingredient can release nicotine or a substance with a similar effect to nicotine, thereby providing a certain nicotine satisfaction to the consumer. The sustained-release ingredient can serve as a carrier of the nicotine active ingredient, thereby adjusting the release rate of the nicotine active ingredient. The binder stabilizes the structure of the oral product and is used to improve the taste consistency of the oral product. The flavoring agent is used to adjust the taste, and the sweetener can increase the diversity of the taste of the oral product. Acid-base regulators are used to adjust the pH value of oral preparations to optimize the stability and release efficiency of the nicotine active ingredient.

[0028] The medicinal ingredients are used to reduce the risk of oxidation of the active ingredient of nicotine during the storage of oral products, and can adjust the release rate of the active ingredient of nicotine. Among them, the medicinal ingredients include antioxidant Chinese herbal medicines, which are in powder form and have a particle size of 50μm-300μm. The experiment found that if the particle size of the antioxidant Chinese herbal medicine is less than 50μm, the particle size of the antioxidant Chinese herbal medicine is small, and under the same mass fraction conditions, the number of particles of the antioxidant Chinese herbal medicine is large, and more particles are mixed with the nicotine active ingredient, it will cause the nicotine active ingredient to be difficult to contact with saliva, and the release rate of the nicotine active ingredient is slow, and it is difficult to meet the requirements of the release rate of the nicotine active ingredient; if the particle size of the antioxidant Chinese herbal medicine is greater than 300μm, the particle size of the antioxidant Chinese herbal medicine is large, and under the same mass fraction conditions, the number of particles of the antioxidant Chinese herbal medicine is small, and fewer particles are mixed with the nicotine active ingredient, it will cause the nicotine active ingredient to contact too much with the saliva, and the release rate of the nicotine active ingredient is fast, which is also difficult to meet the requirements of the release rate of the nicotine active ingredient. In some embodiments, the particle size of the antioxidant Chinese herbal medicine is 50 μm, 80 μm, 100 μm, 120 μm, 150 μm, 180 μm, 200 μm, 220 μm, 250 μm, 280 μm or 300 μm, which is not specifically limited here. Compared with chemical extracts, since the powdered antioxidant Chinese herbal medicine is in a solid state, the release rate of the active ingredient is more stable, and by controlling the particle size of the antioxidant Chinese herbal medicine, the release rate of the active ingredient in the antioxidant Chinese herbal medicine meets the requirements, which is conducive to the stable and sustained release of the nicotine active ingredient.

[0029] The oral preparation provided by the present application is based on the selection of raw material components and the proportional relationship between the raw material components, and the antioxidant Chinese herbal medicine is in powder form, and the particle size of the antioxidant Chinese herbal medicine is 50μm-300μm, so that the antioxidant Chinese herbal medicine can reduce the risk of oxidation of the nicotine active ingredient during storage of the oral preparation; and because the powdered antioxidant Chinese herbal medicine is in a solid state, the release rate of the active ingredient is more stable, and by controlling the particle size of the antioxidant Chinese herbal medicine, the release rate of the active ingredient in the antioxidant Chinese herbal medicine meets the requirements, which is beneficial to the stable and continuous release of the nicotine active ingredient, and the release rate of the nicotine active ingredient can be stably controlled.

[0030] In one embodiment, the composition further comprises 10-20 parts by weight of a solvent.

[0031] In one embodiment, the antioxidant Chinese herbal medicine includes at least one of honeysuckle, dandelion, perilla, aloe, chrysanthemum, mint, licorice, forsythia, scutellaria and isatis root. The above medicinal materials have antioxidant properties and can reduce the risk of oxidation of the nicotine active ingredient during storage of oral products; and after the above medicinal materials are processed into powder, the release rate of the active ingredient is conducive to the stable and continuous release of the nicotine active ingredient.

[0032] In one embodiment, the sustained-release component includes at least one of microcrystalline cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, sodium hydroxymethylcellulose, polyvinyl pyrrolidone, sodium alginate, methylcellulose, hydroxyethyl cellulose, cellulose acetate phthalate, xylitol, mannitol, sorbitol, xylitol, erythritol, maltitol, lactitol, starch and sucrose.

[0033] In one embodiment, the nicotine active ingredient includes at least one of nicotine salt, sodium nicotinate, potassium nicotinate, nicotine and hexamethyl nicotine. The nicotine active ingredient may also include other nicotine derivatives, which are not described here. The nicotine salt may be nicotine tartrate, nicotine benzoate, nicotine lactate, nicotine valerate, nicotine salicylate, and the like.

[0034] In one embodiment, the binder includes at least one of povidone, hydroxypropyl methylcellulose and sodium carboxymethylcellulose.

[0035] In one embodiment, the flavoring agent includes flavors, such as mint flavor, chrysanthemum flavor, citric acid flavor, fruit flavor, coffee flavor, tobacco flavor and other edible flavors.

[0036] In one embodiment, the sweetener includes at least one of stevia, xylitol, ignitol, aspartame, mannitol, sorbitol, erythritol, maltitol, lactitol, saccharin sodium, mongoose, sukram, agave sugar, maple syrup, fructose, neotame, alitame, aspartame, cyclamate, acesulfame potassium, steviol glycosides, monk fruit sweeten and adventitone.

[0037] In one embodiment, the acid-base adjuster includes at least one of sodium carbonate, sodium bicarbonate, citric acid and lactic acid.

[0038] In one embodiment, the solvent includes at least one of water, ethanol, propylene glycol and glycerol.

[0039] In one embodiment, the particle size of the oral product is 50 μm-500 μm or 100 μm-1000 μm. In one embodiment, the particle size of the oral product obtained by fluidized granulation is 50 μm-500 μm. In another embodiment, the particle size of the oral product obtained by wet granulation is 100 μm-1000 μm. By controlling the particle size of the oral product, the consistency of the oral product can be ensured, thereby making the release rate of the nicotine active ingredient of the product meet expectations.

[0040] The composition in the oral product can be in the form of powder, paste, gel, oral dissolving film, tablet or hard candy. In one embodiment, the oral product also includes a permeable bag, which is used to package the composition. When the oral product is placed in the oral cavity, saliva can penetrate the permeable bag, and some substances in the composition are dissolved in the saliva, and then released to the outside through the permeable bag for consumption by the user. That is, the nicotine active ingredient is released into the saliva in the permeable bag, and then penetrates to the outside of the permeable bag with the saliva, and is absorbed or consumed by the user.

[0041] The present application provides a method for preparing an oral product. Figure 1 The preparation method may include steps S10-S50:

[0042] S10, obtaining a powdered antioxidant Chinese herbal medicine with a particle size of 50 μm-300 μm. Compared with chemical extracts, the powdered antioxidant Chinese herbal medicine is in a solid state, and the release rate of the active ingredient is more stable. Furthermore, by controlling the particle size of the antioxidant Chinese herbal medicine, the release rate of the active ingredient in the antioxidant Chinese herbal medicine meets the requirements, which is conducive to the stable and sustained release of the nicotine active ingredient.

[0043] S20, mixing the raw materials to obtain a mixture, wherein the raw materials include, by weight, 20-40 parts of sustained-release ingredients, 1-10 parts of nicotine active ingredients, 20-40 parts of antioxidant Chinese herbal medicines, 0.5-10 parts of binders, 0.1-10 parts of flavoring agents, 0.1-5 parts of sweeteners, and 0.1-5 parts of acid-base regulators. Fully mixing the raw materials can make the distribution of ingredients in the prepared oral product more uniform, thereby improving the taste of the oral product. Based on the selection of raw material components and the proportional relationship between the raw material components, the release rate of the nicotine active ingredient can be stably controlled.

[0044] S30, adding a solvent to the mixed material to obtain a mixed solution, wherein the solvent accounts for 10-20 parts by mass.

[0045] S40, granulating the mixed solution to obtain solid particles. Granulating the mixed solution allows the nicotine active ingredient to adhere to the sustained-release component, and the binder bonds the raw materials together to form a stable structure, which is conducive to the stable and sustained release of the nicotine active ingredient and improves the taste consistency of the oral product.

[0046] S50, crushing the solid particles and sieving them to obtain an oral product. By crushing and sieving the solid particles, the consistency of the oral product can be ensured, so that the release rate of the nicotine active ingredient of the product meets expectations.

[0047] In one embodiment, see Figure 2 , obtaining the antioxidant Chinese herbal medicine in powder form with a particle size of 50 μm-300 μm includes steps S11-S13:

[0048] S11, disinfect and sterilize the antioxidant Chinese herbal medicines. The raw materials of antioxidant Chinese herbal medicines are usually grown in the wild and may be mixed with viruses or bacteria. Disinfection and sterilization can prevent viruses or bacteria from being mixed into the antioxidant Chinese herbal medicines.

[0049] S12, drying the antioxidant Chinese herbal medicine. For example, a fluidized bed dryer can be used to dry the antioxidant Chinese herbal medicine. Through the drying process, the moisture content in the antioxidant Chinese herbal medicine can be reduced, which is convenient for controlling the consistency of the raw materials.

[0050] S13, grinding the antioxidant Chinese herbal medicine to make the particle size of the antioxidant Chinese herbal medicine be 50 μm-300 μm. By controlling the particle size of the antioxidant Chinese herbal medicine, the release rate of the active ingredients in the antioxidant Chinese herbal medicine meets the requirements, which is conducive to the stable and continuous release of the nicotine active ingredient.

[0051] In one embodiment, the sterilization is steam sterilization, and the temperature of steam sterilization is 110° C.-130° C., and the time is 15 min-20 min. Sterilization under steam makes the antioxidant Chinese herbal medicine have a certain moisture content, which can prevent the antioxidant Chinese herbal medicine from decomposing at high temperature.

[0052] In one embodiment, the temperature for drying the antioxidant Chinese herbal medicine is 50°C-70°C, and the moisture content of the antioxidant Chinese herbal medicine after drying is less than or equal to 5%. Controlling the drying temperature to 50°C-70°C can prevent the antioxidant Chinese herbal medicine from decomposing at high temperatures. Controlling the moisture content of the antioxidant Chinese herbal medicine to 5% or less can reduce the effect of moisture in the antioxidant Chinese herbal medicine on the proportion of each raw material component, which is conducive to ensuring the consistency of the oral product.

[0053] In one embodiment, the granulation process includes a fluidized granulation process or a wet granulation process. By using the vulcanization granulation process or the wet granulation process, the nicotine active ingredient can be evenly mixed with the antioxidant Chinese herbal medicine, and the nicotine active ingredient is attached to the sustained-release component, which is conducive to the stable and sustained release of the nicotine active ingredient.

[0054] In one embodiment, the time when 80% of the nicotine active ingredient in the oral product is released is taken as the peak time, and the peak time of the oral product is 5min-20min, or the peak time of the oral product is 20min-35min. Specifically, the peak time of the oral product obtained by fluidized granulation can be 5min-20min, and the peak time of the oral product obtained by wet granulation can be 20min-35min. The peak time of products prepared by different granulation processes is different, which can meet the personalized needs of users.

[0055] The present application is described below through specific examples, in which oral products are prepared according to the above preparation method. The following examples are only partial examples of the present application and are not intended to limit the present application.

[0056] Example A, the formula is shown in Table 1.

[0057] Table 1 Example A formulation (fluidized granulation)

[0058]

[0059] Example B, the formula is shown in Table 2.

[0060] Table 2 Example B formulation (fluidized granulation)

[0061]

[0062]

[0063] Example C, the formula is shown in Table 3.

[0064] Table 3 Example C formulation (wet granulation)

[0065]

[0066] Example D, the formula is shown in Table 4.

[0067] Table 4 Example D formulation (wet granulation)

[0068]

[0069]

[0070] A comparative example was set according to Example A, and the formula of the comparative example is shown in Table 5.

[0071] Table 5 Comparative Example and Example A

[0072] Differences from Example A Comparative Example a Honeysuckle powder 15, water 27 Comparative Example b Honeysuckle powder 45, mannitol 20 Comparative Example c The particle size of honeysuckle powder is 20-45μm Comparative Example d The particle size of honeysuckle powder is 320-400μm Comparative Example e Honeysuckle Extract

[0073] The oral preparations prepared in the examples and comparative examples were subjected to dissolution tests.

[0074] Equipment: Dissolution apparatus-paddle method;

[0075] Sample: 1g of each of the powders of Examples A, B, C, D and Comparative Examples a, b, c, d, e;

[0076] Dissolution medium: artificial saliva-pH 6.8;

[0077] Sampling points: 0.5min, 1min, 2min, 5min, 10min, 15min, 30min, 45min, 60min;

[0078] Test conditions: heating temperature 37°C, speed 100r / min;

[0079] Analysis method: Nicotine content was determined using high performance liquid chromatography.

[0080] The test results are shown in Table 6, Table 7 and Figure 3-Figure 8 shown.

[0081] Table 6 Example test results

[0082] Time(min) A(mg) B(mg) C(mg) D(mg) 0.5 0.46 0.55 1.41 0.77 1 5.82 1.1 3.85 1.54 2 12.4 2.2 11.67 8.08 5 19.35 5.5 19.35 14.77 10 28.99 11 27.63 19.46 15 37.98 16.5 36.55 23.11 30 39.19 18.92 40.55 26.26 45 39.85 19.38 46.25 28.36 60 39.78 19.69 48.97 29.47

[0083] Table 7 Comparative test results

[0084] Time(min) a(mg) b(mg) c(mg) d(mg) e(mg) 0.5 1.32 0.23 0.15 1.82 2.96 1 7.73 3.68 2.77 8.58 10.73 2 9.56 8.16 12.38 10.49 12.81 5 18.27 23.24 16.93 17.77 24.32 10 32.23 32.35 31.54 30.35 31.68 15 36.19 36.58 37.67 34.92 34.14 30 38.25 38.05 38.18 37.63 36.27 45 39.43 38.74 39.26 38.37 37.54 60 39.85 39.62 39.89 39.59 39.86

[0085] from Figure 3-Figure 8It can be seen that in Comparative Examples ad, the dissolution curve forms a bend, and the release rate of the nicotine active ingredient is unstable. The reasons for the unstable release rate of the nicotine active ingredient mainly include the mismatch between the ratios of the raw material components (such as Comparative Examples a and b), the particle size of the antioxidant Chinese herbal medicine is too large or too small (such as Comparative Examples c and d), and the antioxidant Chinese herbal medicine is an extract (such as Comparative Example e). Compared with Comparative Examples ae, the dissolution curves of Examples AD are relatively smooth, that is, the release rate of the nicotine active ingredient in Examples AD is more stable. The test results show that the oral preparation provided by the present application is based on the selection of raw material components and the proportional relationship between the raw material components, and the antioxidant Chinese herbal medicine is in powder form, and the particle size of the antioxidant Chinese herbal medicine is 50μm-300μm, so that the antioxidant Chinese herbal medicine can reduce the risk of oxidation of the nicotine active ingredient during storage of the oral preparation; and because the powdered antioxidant Chinese herbal medicine is in a solid state, the release rate of the active ingredient is more stable, and by controlling the particle size of the antioxidant Chinese herbal medicine, the release rate of the active ingredient in the antioxidant Chinese herbal medicine meets the requirements, which is beneficial to the stable and continuous release of the nicotine active ingredient, and the release rate of the nicotine active ingredient can be stably controlled.

[0086] In addition, from Figure 8 It can be seen that in Examples AD, the time when 80% of the nicotine active ingredient in the oral product is released is taken as the peak time, the peak time of the oral product obtained by fluidized granulation is 5min-20min (Examples A and B), and the peak time of the oral product obtained by wet granulation is 20min-35min (Examples C and D). The products prepared by different granulation processes have different peak times, which can meet the personalized needs of users.

[0087] The above descriptions are only some embodiments of the present application, and do not limit the protection scope of the present application. Any equivalent device or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. An oral product, characterized in that: The invention comprises a composition, wherein the composition comprises, by weight: 1-10 parts of nicotine active ingredient, 20-40 parts of medicinal ingredients, 20-40 parts of sustained-release ingredients, 0.5-10 parts of binders, 0.1-10 parts of flavoring agents, 0.1-5 parts of sweeteners, and 0.1-5 parts of acid-base regulators; Wherein, the medicinal ingredients include antioxidant Chinese herbal medicines, the antioxidant Chinese herbal medicines are in powder form, and the particle size of the antioxidant Chinese herbal medicines is 50 μm-300 μm.

2. The oral product according to claim 1, characterized in that The antioxidant Chinese herbal medicine includes at least one of honeysuckle, dandelion, perilla, aloe, chrysanthemum, mint, liquorice, forsythia, scutellaria and isatis root.

3. The oral product according to claim 1, characterized in that The sustained-release component includes at least one of microcrystalline cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, sodium hydroxymethyl cellulose, polyvinyl pyrrolidone, sodium alginate, methylcellulose, hydroxyethyl cellulose, cellulose acetate phthalate, xylitol, mannitol, sorbitol, xylitol, erythritol, maltitol, lactitol, starch and sucrose; and / or, The nicotine active ingredient includes at least one of nicotine salt, sodium nicotinate, potassium nicotinate, nicotine and hexamethyl nicotine; and / or, The binder comprises at least one of povidone, hydroxypropyl methylcellulose and sodium carboxymethyl cellulose; and / or, The sweetener comprises at least one of stevioside, xylitol, ignol, aspartame, mannitol, sorbitol, erythritol, maltitol, lactitol, saccharin sodium, mongoose, sukram, agave sugar, maple syrup, fructose, neotame, alitame, aspartame, cyclamate, acesulfame potassium, steviol glycoside, monk fruit sweeten and adventitone; and / or, The acid-base regulator includes at least one of sodium carbonate, sodium bicarbonate, citric acid and lactic acid.

4. The oral product according to claim 1, characterized in that The particle size of the oral product is 50 μm-500 μm or 100 μm-1000 μm.

5. The oral product according to any one of claims 1 to 4, characterized in that: The buccal article further comprises a osmotic bag, wherein the osmotic bag is used to package the composition.

6. A method for preparing an oral product, characterized in that: include: Obtaining antioxidant Chinese herbal medicine in powder form with a particle size of 50 μm-300 μm; The raw materials are mixed to obtain a mixture, wherein the raw materials include, by weight: 20-40 parts of a sustained-release component, 1-10 parts of a nicotine active component, 20-40 parts of the antioxidant Chinese herbal medicine, 0.5-10 parts of a binder, 0.1-10 parts of a flavoring agent, 0.1-5 parts of a sweetener, and 0.1-5 parts of an acid-base regulator; Adding a solvent to the mixture to obtain a mixed solution, wherein the solvent is 10-20 parts by mass; Granulating the mixed solution to obtain solid particles; The solid particles are crushed and sieved to obtain the oral product.

7. The preparation method according to claim 6, characterized in that: The method for obtaining the antioxidant Chinese herbal medicine in powder form with a particle size of 50 μm-300 μm comprises: Disinfecting and sterilizing the antioxidant Chinese herbal medicine; Drying the antioxidant Chinese herbal medicine; The antioxidant Chinese herbal medicine is ground to make the particle size of the antioxidant Chinese herbal medicine be 50 μm-300 μm.

8. The preparation method according to claim 7, characterized in that: The disinfection and sterilization is steam disinfection, the temperature of the steam disinfection is 110° C.-130° C., and the time is 15 min-20 min; and / or, The temperature for drying the antioxidant Chinese herbal medicine is 50° C.-70° C., and the moisture content of the antioxidant Chinese herbal medicine after drying is less than or equal to 5%.

9. The preparation method according to claim 6, characterized in that: The granulation process includes a fluidized granulation process or a wet granulation process.

10. The preparation method according to any one of claims 6 to 9, characterized in that: The time when 80% of the nicotine active ingredient in the oral product is released is taken as the peak time, and the peak time of the oral product is 5min-20min, or the peak time of the oral product is 20min-35min.

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