Mouth nicotine product and preparation method thereof

Abstract

The invention discloses a buccal nicotine product and a preparation method thereof, the buccal nicotine product comprises a nicotine composition and a permeation bag, the nicotine composition is packaged in the permeation bag, the permeation bag comprises a bag body and a moisturizing medium, and the moisturizing medium is used for keeping the humidity of the nicotine composition in the bag body. In the buccal nicotine product of the present application, the nicotine composition has a reduced risk of caking.

Description

Technical Field

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

[0002] Currently, there are nicotine bag products on the market, including dry granules and wet granules. Among them, wet granules adopt wet granulation process. The granules prepared by wet granulation have stable quality, uniform particle size and shape, which is conducive to product quality control. The current wet granulation process is roughly as follows: after nicotine and nicotine fillers are made into granules, the granules are packaged in small bags.

[0003] However, the moisture content of the granules produced by the current wet granulation process is usually high, between 20% and 40%. Granules with high moisture content are prone to agglomeration, which will cause large differences in the amount of packaging during the subsequent bagging process. The nicotine content of each bag fluctuates greatly, and the agglomeration of granules will slow down the release rate of nicotine, causing flavor attenuation. Although low moisture content can reduce the agglomeration of granules, it affects the solubility and release rate of the granules and cannot meet user needs. Summary of the invention

[0004] Based on the above problems, the purpose of the present application is to provide an oral nicotine product and a preparation method thereof that can reduce the occurrence of agglomeration of a nicotine composition.

[0005] This application adopts the following technical solutions:

[0006] The present application discloses an oral nicotine product, comprising a nicotine composition and an osmotic bag, wherein the nicotine composition is encapsulated in the osmotic bag, and the osmotic bag comprises a bag body and a moisturizing medium, wherein the moisturizing medium is used to maintain the humidity of the nicotine composition in the bag body.

[0007] In one implementation of the present application, the water content of the oral nicotine product is greater than or equal to the water content of the nicotine composition in the bag body.

[0008] In one implementation of the present application, the water content of the nicotine composition is 10% to 20%, and the water content of the oral nicotine product is 30% to 40%.

[0009] In one implementation of the present application, the moisturizing medium includes water or an aqueous solution containing a moisturizer with a mass fraction of 0.1% to 10%.

[0010] In one implementation of the present application, the moisturizing agent includes at least one of sodium alginate, sodium hyaluronate, hydroxypropyl methylcellulose, coconut oil, glycerin, gum arabic, porous starch, maltodextrin and polyvinyl alcohol.

[0011] In one implementation of the present application, the moisturizing medium includes at least one of a sodium alginate aqueous solution with a mass fraction of 0.1% to 2%, a sodium hyaluronate aqueous solution with a mass fraction of 0.05% to 2%, and a hydroxypropyl methylcellulose aqueous solution with a mass fraction of 0.1% to 10%.

[0012] In one implementation of the present application, the moisturizing medium is sprayed on the outer surface of the bag body, or the moisturizing medium infiltrates the bag body.

[0013] In one implementation of the present application, the nicotine composition includes a functional substance, a filler and water, and the nicotine composition further includes at least one of a binder, a sweetener, a cooling agent, a flavor, an antibacterial agent and a pH adjuster, wherein the functional substance includes nicotine and / or a nicotine derivative.

[0014] In one implementation of the present application, the nicotine composition includes, by weight: 1 to 20 parts of the functional substance, 30 to 99 parts of the filler, 0 to 10 parts of the binder, 0.1 to 10 parts of the sweetener, 0.1 to 10 parts of the flavor, 0.1 to 5 parts of the antibacterial agent, and 0.1 to 10 parts of the pH adjuster.

[0015] The present application also provides a method for preparing an oral nicotine product, comprising: obtaining a nicotine composition, wherein the nicotine composition comprises a functional substance, a filler and water; wherein the functional substance comprises nicotine and / or a nicotine derivative; placing the nicotine composition into a bag body; wherein the bag body is a small bag permeable to saliva; and spraying a moisturizing medium onto at least a portion of the surface of the bag body containing the nicotine composition to obtain the oral nicotine product, wherein the moisturizing medium is used to maintain the humidity of the nicotine composition in the bag body.

[0016] The beneficial effects of this application are:

[0017] The preparation method of the oral nicotine product of the present application, after the nicotine composition is loaded into the bag body, the surface of the bag body is sprayed with a moisturizing medium, which can increase the water content of the oral nicotine product, and the moisturizing medium on the surface of the bag body can further help maintain the humidity of the nicotine composition in the bag body. Compared with the first step of preparing a nicotine composition with a high water content and easy to agglomerate, the preparation method of the present application can reduce the occurrence of agglomeration of the nicotine composition, making the product properties more stable. In addition, the surface of the bag body is sprayed with a moisturizing medium, which can reduce the roughness of the bag body at the entrance and improve the user experience. In the oral nicotine product of the present application, the nicotine composition is encapsulated in a permeable bag, and the permeable bag has a moisturizing medium. The moisturizing medium can help maintain the humidity of the nicotine composition located in the bag body, and can reduce the risk of agglomeration of the nicotine composition in the bag body. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a physical picture of the nicotine composition particles of Example 1 of the present application.

[0019] Figure 2 This is a physical picture of the nicotine composition particles of Comparative Example 1 of the present application.

[0020] Figure 3 This is a physical picture of the nicotine composition particles of Comparative Example 2 of the present application.

[0021] Figure 4 This is a physical picture of the nicotine composition particles of Comparative Example 3 of the present application.

[0022] Figure 5 It is a dissolution curve diagram of the oral nicotine products of Example 1, Example 2, Comparative Example 1 and Comparative Example 2 of the present application. DETAILED DESCRIPTION

[0023] The present invention is further described in detail below by specific embodiments in conjunction with the accompanying drawings. In the following embodiments, many detailed descriptions are intended to enable the present application to be better understood. However, those skilled in the art can effortlessly recognize that some of the features can be omitted in different situations, or can be replaced by other materials and methods. In some cases, some operations related to the present application are not shown or described in the specification, in order to avoid the core part of the present application being overwhelmed by too much description, and for those skilled in the art, it is not necessary to describe these related operations in detail, and they can fully understand the related operations according to the description in the specification and the general technical knowledge in the art.

[0024] In addition, the features, operations or characteristics described in the specification can be combined in any appropriate manner to form various implementations. At the same time, the steps or actions in the method description can also be interchanged or adjusted in a manner that is obvious to those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing a certain embodiment and are not meant to be a required sequence, unless otherwise specified that a certain sequence must be followed.

[0025] The serial numbers assigned to the components in this article, such as "first", "second", etc., are only used to distinguish the objects described and do not have any order or technical meaning.

[0026] In the related art, nicotine bag products include dry granules and wet granules. Among them, wet granule products use a wet granulation process, and their water content can be as high as 20% to 40%, but granules with high water content are prone to agglomeration, which will cause large differences in the amount of filling and large fluctuations in the content during the bagging process. In addition, after the product agglomerates, the release rate of nicotine will be slowed down, causing taste attenuation. At present, the common process to solve the above problem is to remove products with unqualified filling after bagging, which has high requirements for equipment and is wasteful.

[0027] The present application creatively proposes an oral nicotine product and its preparation process, firstly preparing nicotine composition particles with a low water content, because the water content is low, the nicotine composition at this time is less likely to agglomerate; after bagging, spraying a suitable moisturizing medium externally, so that the bag body absorbs part of the moisturizing medium and locks part of the water (in a specific embodiment, the bag body can lock 10% to 15% of the water of the permeation bag mass, for example, if the bag body mass is 35 mg, the bag body can lock about 4 mg of water), after the bag body is saturated with the water, the remaining moisturizing medium can be infiltrated into the bag body again, so as to increase the water content of the oral nicotine product. It should be noted that the applicant has found that by preparing particles with a low water content and less likely to agglomerate in the first step, the agglomeration phenomenon in the later stage will be significantly reduced, and even if agglomerates are formed, the agglomerates are relatively soft and easy to disperse. Since the nicotine composition in the bag body is not stirred after bagging, the moisturizing medium that slowly infiltrates into the bag body from the surface of the bag body will not cause the nicotine composition in the bag body to agglomerate. In summary, compared to preparing a nicotine composition that is easy to agglomerate at high humidity in the first step, the nicotine composition is first prepared at a relatively low humidity and then humidified in the present application, which can significantly reduce the final agglomeration of the nicotine composition particles and make the product properties more stable. In addition, the moisturizing layer formed by the moisturizing medium on the surface of the bag body can reduce the roughness of the bag body at the entrance and improve the user experience; during storage and transportation, this moisturizing layer may evaporate a small amount of water, but the humidity of the contents inside the bag body remains relatively constant. Thus, the problem of high-water content particles being easy to agglomerate in the prior art, which in turn leads to unstable filling and attenuation of nicotine taste, is solved.

[0028] It should be noted that in the present application, water content refers to the mass fraction of water. For example, if the water content of an oral nicotine product is 40%, it means that the mass of water accounts for 40% of the total mass of the oral nicotine product.

[0029] The present application relates to an oral nicotine product, which comprises an osmotic bag and a nicotine composition encapsulated in the osmotic bag.

[0030] In a specific embodiment, the nicotine composition includes a functional substance and a filler. The functional substance includes nicotine and / or nicotine derivatives, and the nicotine derivatives include nicotine salts and nicotine containing substituents, such as nicotine tartrate salts, nicotine lactate salts, hexamethyl nicotine, etc. The filler is mainly used as an excipient and adsorbent to provide a stable matrix to evenly distribute nicotine and other ingredients. The filler is usually water-insoluble and water-absorbent, such as microcrystalline cellulose. Microcrystalline cellulose has good water absorption and swelling properties, can accelerate the disintegration of particles, and promote the release of nicotine. Microcrystalline cellulose can include microcrystalline cellulose of models such as 101, 102, 112, 200, etc.

[0031] In a specific embodiment, the osmotic bag includes a bag body and a moisturizing medium.

[0032] In one embodiment, the moisturizing medium is used to maintain the humidity of the nicotine composition in the bag body.

[0033] In a specific embodiment, the moisturizing medium is used to keep the humidity change of the nicotine composition in the bag body less than 10%. For example, the moisturizing medium can reduce the humidity of the nicotine composition in the bag body by less than 10%.

[0034] In a specific embodiment, the bag body is a saliva-permeable pouch. It should be noted that the bag body allows saliva to pass through, and the water-soluble nicotine and / or nicotine derivatives and other soluble substances dissolve in the saliva and then pass through the bag body into the oral cavity for consumption by the user.

[0035] In a specific embodiment, the bag body is insoluble in water. Thus, the bag body does not need to be dissolved, and nicotine and / or nicotine derivatives and other soluble substances in the nicotine composition can enter the oral cavity from the bag body through saliva.

[0036] In a specific embodiment, the bag body is a heat-sealable pouch, preferably a heat-sealable nonwoven bag body.

[0037] In a specific embodiment, the bag body is made of fiber.

[0038] In a specific embodiment, the bag body is non-woven fabric.

[0039] In a specific embodiment, the width of the bag body is in the range of about 8 mm to about 20 mm; preferably, about 10 mm to about 16 mm. The length of the bag body is in the range of about 20 mm to about 40 mm; preferably, about 25 mm to about 35 mm. It should be noted that this size is conducive to placing the bag body in the oral cavity, such as between the cheek and the gum or between the lips and the gum. Thus, nicotine is released from the bag body and absorbed into the body. In a specific embodiment, the mass of the bag body is 30 mg to 50 mg.

[0040] In a specific embodiment, the moisturizing medium is water or an aqueous solution containing a moisturizing agent with a mass fraction of 0.1% to 10%. For example, the moisturizing medium is an aqueous solution containing a moisturizing agent with a mass fraction of 0.1%, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10%. It should be noted that the moisturizing medium can be water or an aqueous solution containing a moisturizing agent, wherein water as a moisturizing medium can also humidify the bag body and its contents, but the moisturizing effect is relatively general, and the moisturizing medium is preferably an aqueous solution containing a moisturizing agent.

[0041] In a specific embodiment, the moisturizing agent includes at least one of sodium alginate, sodium hyaluronate, hydroxypropyl methylcellulose, coconut oil, glycerin, gum arabic, porous starch, maltodextrin and polyvinyl alcohol, thereby achieving a good moisturizing effect.

[0042] In one embodiment, the moisturizers are all food grade.

[0043] In a specific embodiment, the moisturizing medium is at least one of a sodium alginate aqueous solution with a mass fraction of 0.1% to 2%, a sodium hyaluronate aqueous solution with a mass fraction of 0.05% to 2%, and a hydroxypropyl methylcellulose aqueous solution with a mass fraction of 0.1% to 10%. For example, the moisturizing medium can be a sodium alginate aqueous solution with a mass fraction of 0.1%, 0.5%, 1%, 1.5% or 2%; and / or, a sodium hyaluronate aqueous solution with a mass fraction of 0.05%, 0.1%, 0.5%, 1%, 1.5% or 2%; and / or, a hydroxypropyl methylcellulose aqueous solution with a mass fraction of 0.1%, 0.5%, 1%, 1.5% or 2%.

[0044] In a specific embodiment, the moisturizing medium is a sodium alginate aqueous solution with a mass fraction of 0.1%, or a sodium hyaluronate aqueous solution with a mass fraction of 0.1% to 1.5%, or a hydroxypropyl methylcellulose aqueous solution with a mass fraction of 0.1%.

[0045] In a specific embodiment, the nicotine composition is in the form of particles with a particle size of 100 μm to 500 μm.

[0046] In a specific embodiment, the nicotine composition is also in other forms, such as powder, fiber, microcapsule, sheet, etc.

[0047] In one embodiment, the nicotine composition is prepared by wet granulation. Wet granulation is a commonly used granulation technique that promotes the formation of particles by adding an appropriate amount of liquid (such as water or solvent) to the powder mixture. Therefore, in one embodiment, the nicotine composition includes water.

[0048] In a specific embodiment, the water content of the nicotine composition is 10% to 20%.

[0049] In one specific embodiment, the water content of the oral nicotine product is 20% to 50%.

[0050] In one specific embodiment, the water content of the oral nicotine product is 30% to 40%.

[0051] In a specific embodiment, the nicotine composition further comprises at least one of a binder, a sweetener, a cooling agent, a flavor, an antibacterial agent, and a pH adjuster.

[0052] In a specific embodiment, the nicotine composition includes, by weight: 1 to 20 parts of functional substances, 30 to 99 parts of fillers, 0 to 10 parts of adhesives, 0.1 to 10 parts of sweeteners, 0.1 to 10 parts of flavors, 0.1 to 5 parts of antibacterial agents, and 0.1 to 10 parts of pH adjusters.

[0053] In a specific embodiment, the binder includes at least one of natural plant glue, animal glue, polyvinyl alcohol, polyvinyl pyrrolidone, cellulose derivatives, povidone, sodium alginate and gum arabic.

[0054] In a specific embodiment, the sweetener can be selected from at least one of the following substances: xylitol, sorbitol, mannitol, igloool, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriose, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, sodium cyclamate, alitame, steviol glycosides, arabitol and monk fruit sweetener. The sweetener can also be selected from other edible grade substances, which will not be described one by one in this article.

[0055] In a specific embodiment, the cooling agent can be selected from at least one of the following substances: menthol, isomenthol, WS-3, WS-5, WS-23, WS-27 and WS-12. The cooling agent can also be selected from other edible grade substances, which will not be described in detail herein.

[0056] In a specific embodiment, the flavor is an edible flavor, which may include at least one of bergamot flavor, eucalyptus flavor, citrus flavor, lemon flavor, peppermint flavor, mint flavor, menthol, licorice flavor, wintergreen flavor, tobacco flavor, coffee flavor, vanilla flavor, lime flavor, apple flavor, peach flavor, mango flavor, cherry flavor, blueberry flavor, strawberry flavor, cola flavor, cinnamon flavor, vanilla flavor, and watermelon flavor. The flavor may also be other types of edible flavors, which will not be described in detail herein.

[0057] In a specific embodiment, the antibacterial agent can be selected from at least one of the following substances: ethyl paraben, benzoic acid, sodium benzoate, potassium sorbate. The antibacterial agent can also be selected from other edible antibacterial substances, which will not be described in detail herein.

[0058] In a specific embodiment, the pH adjuster includes at least one of sodium carbonate, sodium bicarbonate, potassium carbonate, magnesium carbonate, potassium bicarbonate, tromethamine and phosphate buffer.

[0059] The oral nicotine product of the present application is described below in conjunction with the preparation method of the oral nicotine product. In a specific embodiment, the oral nicotine product involved in the present application can be prepared by the following preparation method.

[0060] The present application relates to a method for preparing an oral nicotine product (referred to as "preparation method" for short).

[0061] In a specific embodiment, the preparation method includes obtaining a nicotine composition, a bagging step, and a surface treatment step of the bag body.

[0062] In a specific embodiment, in the step of obtaining the nicotine composition, the nicotine composition is prepared into particles according to a recipe.

[0063] In a specific embodiment, in the step of obtaining the nicotine composition, the nicotine composition is prepared into particles with a water content of 10% to 20% by a wet granulation process. In this case, the nicotine composition is first made into particles with a lower water content, which can reduce the phenomenon of agglomeration, and then the nicotine composition is bagged and moisturized after bagging.

[0064] In a specific embodiment, specifically, the granulation step may include:

[0065] 1) Dissolution: According to the formula, add the functional substance, flavor, antibacterial agent, sweetener and pH adjuster into water and dissolve them, stirring until the solution becomes clear.

[0066] 2) Dry mixing: Add the formulated amount of filler and binder into the wet granulation pot and mix evenly; mixing time: 1 to 5 minutes, stirring speed: 100 rpm to 200 rpm.

[0067] 3) Wet granulation: granulation is carried out in a wet granulation pot, liquid spraying, mixing time: 1min to 10min, stirring speed: 100rpm to 200rpm, cutting speed: 500rpm to 2000rpm, to obtain granules with a water content of 10 to 20%.

[0068] It should be noted that the nicotine composition particles prepared by the granulation step of the present application use less water in the formula, and are first prepared by a wet granulation process to form particles with a lower water content. Due to the lower water content (also referred to as "low humidity"), the agglomeration of the particles can be reduced. Therefore, the particles prepared by the granulation process of the present application are less likely to agglomerate.

[0069] In one specific embodiment, in the bagging step, the nicotine composition is filled into a bag body.

[0070] In a specific embodiment, in the bagging step, the prepared particles are evenly distributed into the bag body. The filling amount of the nicotine composition per bag can be 100 mg to 500 mg, and can also be calculated and filled according to other weighing standards.

[0071] In a specific embodiment, in the bag body surface treatment step, a moisturizing medium is sprayed on at least a portion of the surface of the bag body containing the nicotine composition to obtain an oral nicotine product. Preferably, the moisturizing medium is sprayed on most or all of the surface of the bag body.

[0072] In a specific embodiment, during the surface treatment step of the bag body, the bag body is kept stationary. Thus, the agitation of the nicotine composition particles in the bag body caused by the movement or shaking of the bag body can be reduced, thereby preventing the sprayed moisturizing medium from causing the nicotine composition particles to absorb the moisture in the moisturizing medium quickly, resulting in the nicotine composition particles agglomerating. For example, the bag body can be fixedly placed on an operating table or clamped in an operating space, and the moisturizing medium spraying device can be moved to spray the moisturizing medium on the surface of the bag body.

[0073] In a specific embodiment, in the bag body surface treatment step, an atomizing spray gun may be used to spray the moisturizing medium, thereby spraying more evenly.

[0074] In a specific embodiment, in the bag body surface treatment step, the nozzle aperture is 0.4 mm to 1.5 mm. For example, the nozzle aperture can be 0.4 mm, 0.6 mm, 0.8 mm, 1 mm, 1.2 mm or 1.5 mm. Thus, droplets of appropriate size can be generated to spray the surface of the bag body.

[0075] In a specific embodiment, in the bag body surface treatment step, the atomization pressure is 0.02Mpa to 0.2Mpa. For example, the atomization pressure may be 0.02Mpa, 0.06Mpa, 0.1Mpa, 0.12Mpa, 0.15Mpa, 0.18Mpa or 0.2Mpa. Thus, droplets with appropriate pressure can be sprayed on the surface of the bag body. Too high atomization pressure may cause the bag body to be blown.

[0076] In a specific embodiment, in the step of surface treatment of the bag body, the amount of the moisturizing medium used is calculated according to the final overall water content of the oral nicotine product. For example, the water content of the nicotine composition particles obtained after granulation is 10%, and a specific volume or a specific mass of moisturizing medium is sprayed on the surface of the bag body, so that the final overall water content of the oral nicotine product is 40%.

[0077] In a specific embodiment, during the surface treatment step of the bag body, the final overall moisture content of the oral nicotine product is 20% to 50%.

[0078] In a specific embodiment, during the surface treatment step of the bag body, the final overall moisture content of the oral nicotine product is 30% to 40%.

[0079] It should be noted that in the present application, particles with low water content are first prepared by a wet granulation process, and after bagging, a moisturizing medium is sprayed on the surface of the bag body. The sprayed moisturizing medium can form a smooth and moist moisturizing layer on the surface of the bag body. After the bag body absorbs part of the water, the remaining water penetrates into the bag body to humidify the particles. The applicant found that by preparing particles with low relative humidity that are not easy to agglomerate, the agglomeration phenomenon in the later stage will be significantly reduced, and even if agglomerates are formed, the agglomerates are relatively soft and easy to disperse. Therefore, compared with directly preparing particles with high humidity that are easy to agglomerate, the particles with low relative humidity are first prepared in the present application and then humidified, which can significantly reduce the final agglomeration phenomenon of the nicotine composition particles, making the product properties more stable. In addition, the moisturizing layer on the surface of the bag body can improve the roughness of the bag body at the entrance and improve the user experience; during storage and transportation, this moisturizing layer may evaporate a small amount of water, but the humidity of the contents inside the bag body remains relatively constant.

[0080] The present application is further described in detail below by specific examples and comparative examples. The following examples are only further described for the present application and should not be construed as limiting the present application. In the present 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.

[0081] Embodiment 1:

[0082] The ingredients and contents used in the oral nicotine product of Example 1 are as follows:

[0083]

[0084]

[0085] The process steps are as follows:

[0086] Dissolution: Add appropriate amount of water to dissolve functional substances, flavors, antibacterial agents, sweeteners and pH adjusters, and stir until the solution becomes clear.

[0087] Dry mixing: Add filler and binder into the wet granulation pot and mix evenly; mixing time: 3min, stirring speed: 150rpm.

[0088] Wet granulation: Granulation was carried out in a wet granulation pot, liquid spraying, mixing time: 5 min, stirring speed: 150 rpm, cutter speed: 1000 rpm, and granules with a water content of 15% were obtained.

[0089] Bagging: Fill the prepared granules into fiber bags (fiber bag weight 35 mg) at a filling amount of 600 mg / bag, and seal them. The longitudinal sealing temperature is 200±10℃, the front sealing temperature is 150±10℃, and the rear sealing temperature is 130±10℃.

[0090] Bag surface treatment: Place the fiber bag on the operating table and spray the moisturizer onto the bag surface through a spray gun with a nozzle aperture of 1 mm and an atomization pressure of 0.1 MPa; the spraying amount is such that the final water content of the oral nicotine product is about 40% (meaning that the weight of water accounts for 40% of the total weight of the oral nicotine product).

[0091] Embodiment 2:

[0092] The difference between the components and contents used in Example 2 and Example 1 is that the moisturizer used is a 0.1% sodium hyaluronate solution, and the rest is the same as Example 1. The process steps of Example 2 are also the same as those of Example 1.

[0093] Comparative Example 1 and Comparative Example 2 are two nicotine pouch products purchased on the market and prepared by a wet granulation process.

[0094] Comparative Example 3:

[0095] The components and contents used in Comparative Example 3 differ from those in Example 1 in that the mass fraction of water used is 40%, and no humectant is used, and the remaining components are the same as those in Example 1. The process steps of Comparative Example 1 differ from those of Example 1 in that granules with a water content of about 40% are directly prepared by granulation, and there is no step of "bag surface treatment".

[0096] The particles obtained in the examples and comparative examples were observed. Figure 1 is a physical picture of the nicotine composition particles of Example 1 of the present application, Figure 2 is a physical picture of the nicotine composition particles of Comparative Example 1 of the present application, Figure 3 is a physical picture of the nicotine composition particles of Comparative Example 2 of the present application, Figure 4 3 is a physical picture of the nicotine composition particles of Comparative Example 3 of the present application. Figures 1 to 3 The particles prepared in Example 1 of the present application are uniformly dispersed in shape, with very little agglomeration, and the agglomerates are relatively soft and can be dispersed by rubbing; while the particles prepared in Comparative Examples 1 and 2 have obvious agglomeration phenomenon, and the agglomerates are not easy to rub apart. Figure 4 The nicotine composition particles of Comparative Example 3 had a very serious agglomeration phenomenon and could not be accurately sampled at all, so they could not be put into a small bag.

[0097] Nicotine content and water content detection:

[0098] The nicotine content in each oral nicotine product was tested by high performance liquid chromatography, and the water content in each oral nicotine product was tested by weight comparison before and after drying. The results are as follows:

[0099] project Comparative Example 1 Comparative Example 2 Example 1 Example 2 Nicotine label 10mg 12mg 12mg 12mg Actual amount of nicotine 8.5mg 10.5mg 11.7mg 11.9mg Water content 36.2％ 38.5％ 39.6％ 39.2％

[0100] Dissolution curve analysis:

[0101] The dissolution apparatus-paddle method was used to test the nicotine dissolution rate of the oral nicotine products of Example 1, Example 2, Comparative Example 1 and Comparative Example 2 at different time points. The dissolution medium was 500 mL of a phosphate solution of pH 6.8, and the oral nicotine product was placed in the dissolution medium at a temperature of 37° C. and a rotation speed of 50 r / min. Samples were taken at different time points, and the nicotine content was detected by a high performance liquid chromatograph. The sampling points were: 0.5 min, 1 min, 2 min, 5 min, 10 min, 15 min, 20 min, 30 min, 40 min, and 60 min.

[0102] The results are shown in the following table:

[0103]

[0104] Figure 5 is a dissolution curve diagram of the oral nicotine products of Example 1, Example 2, Comparative Example 1 and Comparative Example 2 of the present application, Figure 5 It can be seen that, when the water content of the products is similar, the oral nicotine products of Comparative Examples 1 and 2 release nicotine more slowly than that of Example 1 or Example 2, and have a lower dissolution rate, which may be related to the agglomeration of the products.

[0105] In summary, the oral nicotine product prepared in the embodiment of the present application is first prepared into nicotine composition particles with low relative humidity through a wet granulation process, and then a moisturizing medium is sprayed on the surface of the bag body after bagging. The humidity of the oral nicotine product can be increased and the phenomenon of nicotine composition particles agglomerating can be reduced. At the same time, the bag body absorbs the moisturizing medium, and the surface of the bag body has a smooth and moist moisturizing layer, which can improve the problem of roughness at the entrance of the bag body.

[0106] The above contents are further detailed descriptions of the present application in combination with specific implementation methods, and it cannot be determined that the specific implementation of the present application is 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 nicotine product, characterized in that: The invention comprises a nicotine composition and a permeable bag, wherein the nicotine composition is encapsulated in the permeable bag, and the permeable bag comprises a bag body and a moisturizing medium, wherein the moisturizing medium is used for maintaining the humidity of the nicotine composition in the bag body.

2. The oral nicotine product according to claim 1, characterized in that The water content of the oral nicotine product is greater than or equal to the water content of the nicotine composition in the bag body.

3. The oral nicotine product according to claim 1, characterized in that The water content of the nicotine composition is 10% to 20%, and the water content of the oral nicotine product is 30% to 40%.

4. The oral nicotine product according to claim 1, characterized in that The moisturizing medium includes water or an aqueous solution containing a moisturizing agent with a mass fraction of 0.1% to 10%.

5. The oral nicotine product according to claim 4, characterized in that The moisturizing agent includes at least one of sodium alginate, sodium hyaluronate, hydroxypropyl methylcellulose, coconut oil, glycerin, gum arabic, porous starch, maltodextrin and polyvinyl alcohol.

6. The oral nicotine product according to claim 4, characterized in that The moisturizing medium comprises at least one of a sodium alginate aqueous solution with a mass fraction of 0.1% to 2%, a sodium hyaluronate aqueous solution with a mass fraction of 0.05% to 2%, and a hydroxypropyl methylcellulose aqueous solution with a mass fraction of 0.1% to 10%.

7. The oral nicotine product according to claim 1, characterized in that The moisturizing medium is sprayed on the outer surface of the bag body, or the moisturizing medium infiltrates the bag body.

8. The oral nicotine product according to any one of claims 1 to 7, characterized in that The nicotine composition comprises a functional substance, a filler and water, and the nicotine composition further comprises at least one of a binder, a sweetener, a cooling agent, a flavor, an antibacterial agent and a pH adjuster, wherein the functional substance comprises nicotine and / or a nicotine derivative.

9. The oral nicotine product according to claim 8, characterized in that The nicotine composition comprises, by weight: 1 to 20 parts of the functional substance, 30 to 99 parts of the filler, 0 to 10 parts of the binder, 0.1 to 10 parts of the sweetener, 0.1 to 10 parts of the flavor, 0.1 to 5 parts of the antibacterial agent, and 0.1 to 10 parts of the pH adjuster.

10. A method for preparing an oral nicotine product, characterized in that: include: Obtaining a nicotine composition, wherein the nicotine composition comprises a functional substance, a filler and water; wherein the functional substance comprises nicotine and / or a nicotine derivative; The nicotine composition is placed in a bag body; wherein the bag body is a small bag permeable to saliva; The oral nicotine product is obtained by spraying a moisturizing medium onto at least a portion of the surface of the bag body containing the nicotine composition, wherein the moisturizing medium is used to maintain the humidity of the nicotine composition in the bag body.

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