A dynamic diaphragm controlled release type nicotine pouch and a method of preparing the same

Abstract

The application discloses a dynamic diaphragm controlled-release type nicotine bag and a preparation method thereof. The nicotine bag comprises a nicotine content and a saliva-permeable pouch. The nicotine content comprises a nicotine source and a controlled-release agent. The controlled-release agent can swell to form a viscous paste diaphragm in the saliva-permeable pouch within 20 seconds after meeting water or saliva. The release rate of the nicotine source is controlled by the dissolution rate of the viscous paste diaphragm, so that the nicotine source cannot be rapidly released through the viscous paste diaphragm and the saliva-permeable pouch, and the initial burst release of the nicotine source is avoided. The dynamic viscosity of the viscous paste diaphragm is greater than or equal to 20,000 mPa·s, and the total dissolution time of the viscous paste diaphragm is greater than or equal to 30 minutes. The industry problem of "initial burst release stimulation and insufficient release in the later period" of the existing nicotine bag is solved from the root, the nicotine is uniformly and gradiently released, the overall taste experience of the user is further improved, and the production process of the nicotine bag is simplified.

Description

Technical Field

[0001] This application belongs to the technical field of oral nicotine products, specifically relating to a dynamic diaphragm controlled-release nicotine bag and its preparation method. Background Technology

[0002] As a core category of smoking cessation products, the controllability of nicotine release rate is a key indicator determining product safety, user experience, and physiological satisfaction. Currently, mainstream nicotine pouch products on the market complete the main nicotine release process within 10 minutes. Excessive nicotine release reduces the effective consumption time and can easily cause acute discomfort such as oral irritation, dizziness, and nausea.

[0003] Currently, mainstream nicotine sustained-release technologies in the industry are mainly divided into three categories: matrix-embedded sustained-release technology, ion exchange adsorption sustained-release technology, and non-woven fabric pre-coating modification technology, but all have shortcomings. Among them, matrix-embedded sustained-release technology: the release curve is prone to imbalance, generally exhibiting initial burst release and insufficient release in the later stages. In commercially available products and related patented formulations, the cumulative nicotine release within 5 minutes generally exceeds 70%, easily causing oral irritation and physical discomfort; it relies on a complex system of "compound binder + compound dispersant," resulting in cumbersome formulations, high raw material costs, and large batch-to-batch fluctuations in release effects; it completely disregards the synergistic effect between non-woven fabric and matrix sustained-release materials, relying solely on internal matrix regulation, leading to an extremely low upper limit for sustained-release effect; ion exchange adsorption sustained-release technology... Nicotine release rate is highly dependent on the ion concentration and secretion of the user's saliva. Individual differences lead to huge fluctuations in the effect of use. The release amount of the same product can vary by up to 40% among different users in 30 minutes. Moreover, ion exchange resin can easily cause a foreign body sensation and bitter taste in the mouth, resulting in a poor taste experience and low acceptance among the audience. Non-woven fabric pre-coating modification technology: It adopts a static pre-coated coating, which can only achieve single-stage controlled release. After the coating dissolves, the saliva penetration rate becomes uncontrollable, making it difficult to control the later release of nicotine. In addition, it does not form a combination with the matrix material, resulting in poor overall sustained release.

[0004] Meanwhile, all existing technologies treat nonwoven fabrics merely as ordinary packaging carriers, failing to establish a synergistic matching system between "in-matrix sustained-release materials and nonwoven fabric pore size." For example, patent document CN121128957A discloses an oral nicotine pouch product and its preparation method, including contents and outer packaging. The contents include nicotine source and acidic pH adjuster, and the outer packaging is a saliva-permeable pouch used to seal the contents. This ignores the fact that the pore size of the nonwoven fabric is one of the core parameters for regulating saliva permeability and determining the sustained-release effect, further leading to the industry's inability to break through the technical bottleneck of "unstable controlled release and poor user experience."

[0005] Therefore, it is necessary to reconstruct the nicotine controlled-release mechanism, break away from the existing technology of locking nicotine in the matrix for slow release, and fundamentally solve the industry problem of "initial burst release stimulation and insufficient release in the later stage" of existing nicotine bags through the reciprocating controlled-release mechanism of dynamic diaphragms. This will enable the uniform and gradient controllable release of nicotine throughout the process, further improve the overall taste experience for users, and simplify the production process of nicotine bags. Summary of the Invention

[0006] The purpose of this application is to provide a dynamic diaphragm controlled-release nicotine bag and its preparation method. By using the reciprocating controlled-release mechanism of the dynamic diaphragm, the application aims to fundamentally solve the industry problem of "initial burst release stimulation and insufficient release in the later stage" in existing nicotine bags, achieve uniform and gradient controllable release of nicotine throughout the process, further improve the overall taste experience for users, and simplify the production process of nicotine bags.

[0007] To solve the above-mentioned technical problems, this application provides the following technical solution: This application provides a dynamic diaphragm controlled-release nicotine bag, which includes nicotine contents and a saliva-permeable pouch; The nicotine contents include the nicotine source and the controlled-release agent. The controlled-release agent swells within the saliva-permeable sachet within 20 seconds after contact with water or saliva, forming a viscous paste-like membrane. This membrane regulates the release rate of the nicotine source. The release rate of the nicotine source is controlled by the dissolution rate of the paste-like membrane. The nicotine source cannot be rapidly released through the paste-like membrane and the saliva-permeable sachet, thus preventing a burst release of nicotine source at the initial stage of consumption. The dynamic viscosity of the paste-like membrane is ≥20000 mPa·s, the paste-like membrane can be completely dissolved in saliva, and the cumulative time for the paste-like membrane formed by nicotine contents to be completely dissolved in saliva is ≥30 min.

[0008] Furthermore, it can be understood that the controlled-release agent swells within the saliva-permeable pouch within 20 seconds of contact with water or saliva, causing the nicotine contents to form a viscous paste-like membrane. The release rate of the nicotine source is regulated by the dissolution rate of the paste-like membrane in saliva, thereby achieving uniform release of the nicotine source through the paste-like membrane and the saliva-permeable pouch, avoiding a burst release of nicotine source in the initial stage of consumption.

[0009] Furthermore, the saliva-permeable pouches include food-grade nonwoven fabric.

[0010] Furthermore, the pore size of food-grade nonwoven fabrics is 10-20 μm, 20-25 μm, 25-30 μm, 30-35 μm or 35-50 μm.

[0011] Furthermore, food-grade nonwoven fabrics have an air permeability of 800-900 L / m². 2·s、900-1100 L / m 2 ·s or 1100-1200 L / m 2 ·s.

[0012] Furthermore, this is to prevent the nicotine contents from leaking out through the pores of the saliva-permeable pouch before forming a paste-like septum.

[0013] Furthermore, the basis weight of food-grade nonwoven fabric is 25-30 g / m². 2 30-32 g / m 2 Or 30-35 g / m 2。

[0014] Furthermore, the thickness of food-grade nonwoven fabric is 0.20-0.22 mm, 0.22-0.26 mm, 0.26-0.28 mm, 0.28-0.30 mm, 0.30-0.33 mm or 0.33-0.36 mm.

[0015] Furthermore, nicotine contents also include fillers and flavorings; per 100 servings of nicotine contents, it includes: Nicotine source: 0.1-1.0 part, 1.0-2.0 part, 2.0-3.0 part, or 3.0-5.0 part; 65-70 parts, 70-75 parts, or 75-80 parts of filler; 3-5 parts, 5-10 parts, or 10-20 parts of controlled-release agent; Seasoning 1-3 parts; 3-8 parts or 8-12 parts.

[0016] Furthermore, the controlled-release agent includes one or more combinations of cellulose ethers, natural plant gums, pregelatinized starch, or sodium alginate.

[0017] Furthermore, cellulose ethers include one or more combinations of hydroxyethyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, or hydroxypropyl cellulose; natural plant gums include one or more combinations of xanthan gum, guar gum, locust bean gum, carrageenan, gum arabic, or konjac gum.

[0018] Furthermore, nicotine sources include one or more combinations of nicotine salts, nicotine bases, or tobacco extracts.

[0019] Furthermore, nicotine salts include nicotine hydrochloride, nicotine dihydrochloride, nicotine phosphate, nicotine sulfate, nicotine hydrogen tartrate, nicotine hydrogen tartrate dihydrate, nicotine pyruvate, nicotine formate, nicotine oxalate, nicotine ascorbate, nicotine glycolate, nicotine acetate, nicotine isovalerate, nicotine valerate, nicotine propionate, nicotine caprylate, nicotine lactate, nicotine levulinate, nicotine sorbate, nicotine malate, nicotine fumarate, nicotine salicylate, nicotine glycinate, nicotine tartrate, nicotine succinate, and nicotine citrate. Nicotine benzoate, nicotine resinate, nicotine oleate, nicotine aconitate, nicotine butyrate, nicotine cinnamate, nicotine caprate, nicotine 3,7-dimethyl-6-octenate, nicotine 1-glutamate, nicotine heptamate, nicotine hexanoate, nicotine 3-hexenoate, nicotine trans-2-hexenoate, nicotine isobutyrate, nicotine laurate, nicotine 2-methylbutyrate, nicotine 2-methylvalerate, nicotine myristate, nicotine nonanoate, nicotine palmitate, nicotine 4-pentenoate, nicotine phenylacetate, or nicotine 3-phenylpropionate, or one or more combinations thereof.

[0020] Furthermore, the filler includes microcrystalline cellulose.

[0021] Furthermore, flavoring agents include one or more combinations of flavorings, flavoring agents, and cooling agents.

[0022] Furthermore, the flavoring and fragrance components are in the amount of 3-6 parts by weight, the flavoring agent is in the amount of 1-3 parts by weight, and the cooling agent is in the amount of 1-3 parts by weight.

[0023] Furthermore, the flavorings include one or more combinations of food-grade peppermint flavoring, fruit flavoring, herbal flavoring, or tobacco flavoring; the flavoring agents include one or more combinations of edible salt, steviol glycosides, sucralose, neotame, aspartame, acesulfame potassium, cyclamate, sodium saccharin, sodium cyclohexylsulfamate, disodium glycyrrhizate, or tripotassium and trisodium glycyrrhizate; and the cooling agents include one or more combinations of menthol, mentholamide, or W23.

[0024] Furthermore, the amount of nicotine contents in the nicotine pouch is 0.1-0.3 g, 0.3-0.4 g, or 0.4-0.5 g, so that the cumulative release rate of the nicotine source in the nicotine pouch is 10-20% in the first 0-5 minutes, 30-50% in the second 5-10 minutes, and ≥90% in the third 30 minutes.

[0025] This application also provides a method for preparing a dynamic diaphragm controlled-release nicotine bag, comprising the following steps: Step A: Pre-treat the nicotine source, controlled-release agent, filler, and flavoring agent by passing them through an 80-100 mesh sieve to obtain pre-treated nicotine source, pre-treated controlled-release agent, pre-treated filler, and pre-treated flavoring agent, respectively. Step B: Mix the pretreated nicotine source, pretreated controlled-release agent, pretreated filler and pretreated flavoring agent in a mass ratio of (1-5):(3-20):(65-80):(1-12). The amount of pretreated controlled-release agent, pretreated filler and pretreated flavoring agent increases with the amount of pretreated nicotine source added to obtain nicotine contents. Step C: Fill the nicotine contents into saliva-permeable pouches, and obtain nicotine pouches after heat sealing and ultraviolet sterilization.

[0026] Furthermore, in step B, the homogeneity of the nicotine contents is 2.0-2.2%, 2.2-2.5%, or 2.5-3.0%.

[0027] Furthermore, in step C, the heat-sealing temperature is 130-140℃, 140-145℃, or 145-150℃, and the heat-sealing time is 0.5-0.7 s, 0.7-0.8 s, or 0.8-1.0 s.

[0028] Furthermore, the materials used for saliva-permeable pouches include one or more combinations of polypropylene fibers, polyester fibers, polyamide fibers, polytetrafluoroethylene fibers, and glass fibers.

[0029] Compared with the prior art, this application has the following beneficial technical effects: This application provides a dynamic diaphragm controlled-release nicotine pouch and its preparation method. After the controlled-release agent inside the nicotine pouch comes into contact with saliva, a paste-like diaphragm is formed in real time on the inner side of the non-woven fabric. The nicotine release rate is determined by the dissolution rate of the diaphragm, and the nicotine is released slowly through a repetitive process of "diaphragm formation-dissolution-reformation". This fundamentally solves the industry problem of "initial burst release stimulation and insufficient release in the later stage" in existing nicotine pouches, and achieves uniform and gradient controllable release of nicotine throughout the process, further improving the overall taste experience for users and simplifying the production process of nicotine pouches. Attached Figure Description

[0030] The above description of this application and the following detailed embodiments will be better understood when read in conjunction with the accompanying drawings. It should be noted that the drawings are merely examples of the claimed technical solutions.

[0031] Figure 1 This is a flowchart illustrating the preparation process of the dynamic diaphragm controlled-release nicotine bag in a specific embodiment of this application; Figure 2This is a schematic diagram of the structure of the dynamic diaphragm controlled-release nicotine bag in a specific embodiment of this application; Figure 3 This is a process diagram illustrating the preparation of the dynamic diaphragm controlled-release nicotine bag in a specific embodiment of this application.

[0032] The reference numerals in the attached figures are explained as follows: Nicotine bags: 10; Nonwoven fabrics: 11; Nicotine bag contents: 12; Horizontal seam: 13; Longitudinal joint: 14; Equipment for manufacturing bagged products for oral use: 20; Packaging materials roll: 21; Packaging materials: 22; Feed port: 23; Management institutions: 24; First seam mechanism: 25; Second seam mechanism: 26. Detailed Implementation

[0033] The following detailed description of the features and advantages of this application is sufficient to enable any person skilled in the art to understand the technical content of this application and implement it accordingly. Based on the specification, claims and drawings disclosed in this specification, those skilled in the art can easily understand the related objectives and advantages of this application.

[0034] In this specification and claims, several terms will be used, and unless otherwise indicated, these terms will be defined to have the following meanings: Dynamic membrane controlled release: This refers to a controlled release technology in which the controlled release agent inside the nicotine pouch forms a paste-like membrane in real time on the inner side of the adaptable nonwoven fabric after contacting saliva. Through the repeated process of "membrane formation-dissolution-reformation", the release rate of nicotine is precisely controlled. Its achievement depends on the precise matching between the water solubility state of the controlled release additive and the pore size of the nonwoven fabric.

[0035] Controlled-release agent: refers to food-grade polymeric material that can rapidly swell to form a viscous paste upon contact with water. It is the core functional material for achieving dynamic membrane controlled release. Its judgment criteria are: in an artificial saliva environment at 37℃ and pH 6.8, the test material rapidly forms a high-viscosity paste-like liquid upon contact with saliva (dynamic viscosity ≥20000 mPa·s).

[0036] All figures used to represent component amounts, properties (e.g., weight-average molecular weight), reaction conditions, etc., should be considered to be modified in all cases by the terms "within the unavoidable margin of error" or "about". Therefore, the numerical values ​​set forth herein are approximate and may vary depending on the desired properties sought to be obtained in this application. The principle of equivalents, which is applied to a minimum and not intended to limit the scope of the claims, should be applied, for example, each value should be interpreted at least according to the reported significant digits and by applying conventional rounding techniques.

[0037] All other terms used herein for special definition are intended to have the general meaning understood by one of ordinary skill in the art, in particular, meaning that one of ordinary skill in the art can directly and without doubt determine how the technical solution of this application can be implemented after reading the claims, description and drawings of this application.

[0038] Even if there are incomplete descriptions, omissions, or ambiguities in the grammar, words, punctuation, graphics, symbols, etc. of the claims, description, and drawings of this application, those skilled in the art can still arrive at the only correct understanding by reading the claims, description, and drawings as a whole without extensive reasoning or experimentation, and effectively exclude various incorrect interpretations that are not aimed at achieving the purpose of this application.

[0039] The "range" disclosed herein is defined by a lower limit and an upper limit. A given range is defined by selecting a lower limit and an upper limit, which define the boundaries of a particular range. Ranges defined in this way can include or exclude endpoints and can be arbitrarily combined; that is, any lower limit can be combined with any upper limit to form a range. For example, if ranges of 60-120 and 80-110 are listed for a specific parameter, it is expected that ranges of 60-110 and 80-120 are also expected. Furthermore, if minimum range values ​​of 1 and 2 are listed, and if maximum range values ​​of 3, 4, and 5 are listed, then the following ranges are all expected: 1-3, 1-4, 1-5, 2-3, 2-4, and 2-5. In this application, unless otherwise stated, the numerical range "ab" represents a shortened representation of any combination of real numbers between a and b, where a and b are real numbers. For example, the numerical range "0-5" indicates that all real numbers between "0-5" have been listed in this article; "0-5" is simply a shortened representation of these numerical combinations. Furthermore, when a parameter is stated as an integer ≥2, it is equivalent to disclosing that the parameter is, for example, an integer such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, etc.

[0040] Unless otherwise specified, all embodiments and preferred embodiments mentioned herein can be combined to form new technical solutions.

[0041] Unless otherwise specified, all the technical features and preferred features mentioned herein can be combined to form new technical solutions.

[0042] Unless otherwise specified, all steps mentioned herein may be performed sequentially or randomly, but are preferably performed sequentially. For example, the method includes steps (a) and (b), indicating that the method may include steps (a) and (b) performed sequentially, or it may include steps (b) and (a) performed sequentially. For example, the mention that the method may also include step (c) indicates that step (c) may be added to the method in any order; for example, the method may include steps (a), (b), and (c), or it may include steps (a), (c), and (b), or it may include steps (c), (a), and (b), etc.

[0043] Unless otherwise specified, the terms "comprising" and "including" as used herein can be open-ended or closed-ended. For example, "comprising" and "including" may mean that other components not listed may also be included, or that only the listed components may be included.

[0044] In the description of this article, it should be noted that, unless otherwise stated, "above" and "below" include the number itself, and "several" in "one or more" means two or more.

[0045] In this description, unless otherwise stated, the term "or" is inclusive. For example, the phrase "A or B" means "A, B, or both A and B". More specifically, the condition "A or B" is satisfied by any of the following conditions: A is true (or exists) and B is false (or does not exist); A is false (or does not exist) and B is true (or exists); or both A and B are true (or exist).

[0046] Unless otherwise specified, percentages (%) in this document refer to percentages by mass relative to the composition.

[0047] Unless otherwise stated herein, the sum of the contents of the components in the composition is 100%.

[0048] In this document, unless otherwise stated, “combination of” means a multi-component mixture of the elements, such as two, three, four, and up to the maximum possible multi-component mixture.

[0049] Unless otherwise specified, the term "a" as used in this specification means "at least one".

[0050] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0051] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0052] To make the objectives, technical solutions, and advantages of the present invention clearer, the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings. Unless otherwise specified, the experimental methods described in the embodiments of the present invention are conventional methods, and the materials and reagents used in the following embodiments are commercially available unless otherwise specified.

[0053] like Figure 1 As shown, this application provides a dynamic diaphragm controlled-release nicotine bag and its preparation method, including the following steps: (1) The nicotine source, filler, controlled release agent and flavoring agent are passed through an 80-100 mesh screen, and the moisture content is controlled to be ≤5%. The production environment temperature is 20-25℃ and the relative humidity is ≤45% to avoid the raw materials from absorbing moisture and clumping. The pretreated raw materials of the corresponding components are obtained respectively.

[0054] The nicotine source includes one or more combinations of nicotine salts, free nicotine bases, or tobacco extracts; nicotine salts include nicotine hydrochloride, nicotine dihydrochloride, nicotine phosphate, nicotine sulfate, nicotine hydrogen tartrate, nicotine hydrogen tartrate dihydrate, nicotine pyruvate, nicotine formate, nicotine oxalate, nicotine ascorbate, nicotine glycolate, nicotine acetate, nicotine isovalerate, nicotine valerate, nicotine propionate, nicotine caprylate, nicotine lactate, nicotine acetylpropionate, nicotine sorbate, nicotine malate, nicotine fumarate, nicotine salicylate, nicotine glycinate, nicotine tartrate, etc. Nicotine succinate, nicotine citrate, nicotine benzoate, nicotine resinate, nicotine oleate, nicotine aconitate, nicotine butyrate, nicotine cinnamate, nicotine caprate, nicotine 3,7-dimethyl-6-octenate, nicotine 1-glutamate, nicotine heptarate, nicotine hexanoate, nicotine 3-hexenoate, nicotine trans-2-hexenoate, nicotine isobutyrate, nicotine laurate, nicotine 2-methylbutyrate, nicotine 2-methylvalerate, nicotine myristate, nicotine nonanoate, nicotine palmitate, nicotine 4-pentenoate, nicotine phenylacetate, or nicotine 3-phenylpropionate, or one or more combinations thereof.

[0055] The filler includes microcrystalline cellulose.

[0056] The controlled-release agent includes one or more combinations of cellulose ethers, natural plant gums, pregelatinized starch, or sodium alginate; the cellulose ethers include one or more combinations of hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC), sodium carboxymethyl cellulose (CMC), or hydroxypropyl cellulose (HPC); the natural plant gums include one or more combinations of xanthan gum, guar gum, locust bean gum, carrageenan, gum arabic, or konjac gum.

[0057] Flavoring agents include one or more combinations of flavorings, flavoring agents, and cooling agents; flavorings include one or more combinations of food-grade peppermint flavoring, fruit flavoring, herbal flavoring, or tobacco flavoring; fruit flavorings are a non-exhaustive list, including coconut, green apple, blueberry, mango, grapefruit, orange, lime, bergamot, lemon, pineapple, strawberry, raspberry, cherry, watermelon, pear, peach, apricot, raspberry, lime, plum, etc.; herbal flavorings include cinnamon, cumin, pepper, deer hoof grass, eucalyptus, clove, bay leaf, fennel, thyme, cedar leaf oil, nutmeg, vanilla, licorice, etc.; flavoring agents include one or more combinations of edible salt, steviol glycosides, sucralose, neotame, aspartame, acesulfame potassium, cyclamate, sodium saccharin, sodium cyclohexylsulfamate, disodium glycyrrhizate, or tripotassium and trisodium glycyrrhizate; cooling agents include one or more combinations of menthol, mentholamide, or W23.

[0058] (2) Taking 100 parts of nicotine contents as the mass, the above-mentioned pretreated raw materials: 0.1-5.0 parts of nicotine source, 65-80 parts of filler, 3-20 parts of controlled release agent and 1-12 parts of flavoring agent are placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed is 18-20 r / min, 20-22 r / min or 22-25 r / min, and the time is 25-30 min, 30-35 min or 35-40 min, so as to ensure that each component can be evenly dispersed, so that the mixing uniformity RSD is 2.0-2.2%, 2.2-2.5% or 2.5-3.0%, and the premixed material is the nicotine contents.

[0059] The seasoning, which is 1-12 parts by weight, includes: 3-6 parts by weight of flavoring and fragrance, 1-3 parts by weight of flavoring agent, and 1-3 parts by weight of cooling agent.

[0060] In some specific embodiments, a controlled-release agent with a high nicotine release rate is preferably a low-viscosity agent with a slightly faster dissolution rate, the low viscosity range being 20,000-30,000 mPa·s; including HPMC, HPC, CMC, HEC, and sodium alginate, with an addition amount preferably of 10-20 parts; a controlled-release agent with a low nicotine release rate is preferably a high-viscosity agent with stronger paste-forming and water-locking properties, the high viscosity range being >30,000 mPa·s; including guar gum, xanthan gum, carrageenan, locust bean gum, gum arabic, pregelatinized starch, and konjac gum, with an addition amount preferably of 3-10 parts.

[0061] (3) Using existing fully automated nicotine bag production equipment, the nicotine contents obtained in step (2) above are filled into saliva-permeable bags. The saliva-permeable bags include food-grade non-woven fabric. After heat sealing and ultraviolet sterilization, the nicotine bags are obtained.

[0062] The structure of nicotine bag 10 is as follows Figure 2 As shown, the nicotine bag 10 is typically made of non-woven fabric 11 or other non-woven materials, and the nicotine contents 12 prepared above are wrapped in it using specialized equipment. The nicotine bag 10 has serrated transverse seams 13 on both sides and a longitudinal seam 14 in the middle.

[0063] The manufacturing process of nicotine pouch 10 is as follows: Figure 3As shown, nicotine pouches 10 are manufactured using a bag-making equipment 20, which combines packaging materials and nicotine contents 12. A roll 21 of packaging material is unrolled into a strip 22 and fed into a tube-forming mechanism 24, gradually forming a non-woven tube with a tubular structure. A longitudinal seam 14 is formed by high-temperature rollers on a first seam mechanism 25, thus shaping the pouch into a saliva-permeable bag. A measured amount of nicotine contents 12 is periodically fed into the saliva-permeable pouch through a feeding port 23. Then, a second seam mechanism 26 is activated, using its high-temperature clamps to form a new transverse seam at the upper end of the saliva-permeable pouch. The pouch is then serrated, with the lower half forming the transverse seam 13 at the upper end of the nicotine pouch 10, and the upper half forming the transverse seam 14 at the lower end of a new nicotine pouch 10. The nicotine contents 12 are fed in again, and this process is repeated continuously to manufacture nicotine pouches 10.

[0064] The nicotine content is 0.1-0.3 g, 0.3-0.4 g, or 0.4-0.5 g, the heat-sealing temperature is 130-140℃, 140-145℃, or 145-150℃, and the heat-sealing time is 0.5-0.7 s, 0.7-0.8 s, or 0.8-1.0 s.

[0065] The basis weight of food-grade spunlace nonwoven fabric is 25-30 g / m². 2 30-32 g / m 2 Or 30-35 g / m 2 The pore size is 10-20 μm, 20-25 μm, 25-30 μm, 30-35 μm or 35-50 μm, the thickness is 0.20-0.22 mm, 0.22-0.26 mm, 0.26-0.28 mm, 0.28-0.30 mm, 0.30-0.33 mm or 0.33-0.36 mm, and the air permeability is 800-900 L / m³. 2 ·s、900-1100 L / m 2 ·s or 1100-1200 L / m 2 •s; This range ensures that the paste formed upon contact with water will not be lost through the pores, and can stably accumulate on the inside of the nonwoven fabric to form a continuous and dense paste membrane, while not completely blocking saliva penetration and nicotine release, thus balancing the sustained-release effect and the user experience.

[0066] When the nonwoven fabric has low permeability, the pore size is 10-25 μm, the thickness is 0.3-0.4 mm, and the basis weight is 30-35 g / m². 2 Breathability 800-1000 L / m 2 •s; Low permeability leads to a slow saliva penetration rate, and the formation of a paste-like membrane excessively blocks substance exchange, ultimately resulting in insufficient nicotine release.

[0067] When the nonwoven fabric has high permeability, the pore size is 25-50 μm, the thickness is 0.2-0.3 mm, and the basis weight is 25-30 g / m². 2 Breathability 1000-1200 L / m 2 •s; If the permeability is too low, the paste formed when exposed to water will be lost in large quantities through the pores of the nonwoven fabric, making it impossible to form a continuous and stable paste membrane on the inside of the nonwoven fabric. The physical barrier function will be completely ineffective, ultimately leading to the problem of nicotine burst release.

[0068] Food-grade nonwoven fabrics are made of one or more combinations of polypropylene fibers, polyester fibers, polyamide fibers, polytetrafluoroethylene fibers, and glass fibers.

[0069] In some other embodiments, the material of the saliva-permeable pouch may also be one of Lyocell, Modal, or Tencel.

[0070] The controlled-release principle of nicotine in the nicotine bag prepared by the method described in this application is as follows: (1) Initial contact stage: After the nicotine bag product is placed in the mouth, saliva seeps into the bag through the pores of the non-woven fabric and comes into contact with the controlled-release additive in the matrix. The additive absorbs water to form a viscous paste. (2) Diaphragm formation stage: The paste accumulates in the pores and inner surface of the nonwoven fabric along the direction of saliva penetration. Because the pore size of the nonwoven fabric is precisely matched with the viscosity of the paste, the paste will not be lost quickly through the pores. Moreover, the paste itself dissolves slowly, thus forming a continuous and dense paste diaphragm, which inhibits the rapid penetration of saliva and the rapid dissolution of nicotine in the mechanism through physical barrier. (3) Synchronous release stage: The infiltrated saliva gradually dissolves the nicotine in the paste matrix on the non-woven fabric, and the dissolved nicotine is released into the oral cavity and absorbed by the mucosa; the release rate of nicotine in this stage is determined by the dissolution rate of the paste membrane and the pore size of the non-woven fabric, so as to achieve uniform release. (4) Reciprocating cycle stage: As saliva continues to wash and dissolve in the mouth, the surface paste-like membrane on the inner side of the non-woven fabric slowly dissolves, the physical barrier effect weakens, and new saliva seeps into the bag again, comes into contact with the undissolved controlled-release additives inside the matrix, and forms a new paste-like membrane again, re-establishing a stable barrier effect. (5) Release endpoint: As the controlled-release additives are completely dissolved, the paste membrane no longer forms, and the nicotine in the matrix is ​​completely released, achieving a gradient, uniform, and controllable sustained-release effect throughout the process.

[0071] Example 1

[0072] (1) Nicotine malate, microcrystalline cellulose, sodium carboxymethyl cellulose (CMC), peppermint flavor, sucralose and menthol were passed through an 80-mesh sieve to obtain pretreated raw materials of the corresponding components. The moisture content of the pretreated raw materials was found to be 4.2%.

[0073] (2) Taking 100 parts of nicotine contents as the mass, the above-mentioned pretreated raw materials: 4 parts of nicotine malate, 75 parts of microcrystalline cellulose, 15 parts of sodium carboxymethyl cellulose (CMC), 3 parts of peppermint flavoring, 1 part of sucralose and 2 parts of menthol are placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed is 18 r / min and the time is 30 min to ensure that each component can be evenly dispersed, so that the mixing uniformity RSD is 2.7%, and the premixed material is the nicotine contents.

[0074] (3) Using existing fully automated nicotine bag production equipment, the nicotine contents obtained in step (2) above are filled into saliva-permeable pouches. The saliva-permeable pouches are made of food-grade non-woven fabric and are obtained after heat sealing and ultraviolet sterilization.

[0075] The nicotine content is 0.5 g, the heat-sealing temperature is 130℃, and the heat-sealing time is 1.0 s; the basis weight of the food-grade spunlace nonwoven fabric is 32 g / m². 2 It has a pore size of 18 μm, a thickness of 0.35 mm, and an air permeability of 920 L / m³. 2 ·s.

[0076] Example 2

[0077] (1) Nicotine tartrate, microcrystalline cellulose, konjac gum, peppermint flavor, maltitol and mentholamide were passed through an 80-mesh sieve to obtain pretreated raw materials of the corresponding components. The moisture content of the pretreated raw materials was found to be 3.8%.

[0078] (2) Taking 100 parts of nicotine contents as the mass, the above-mentioned pretreated raw materials: 2 parts of nicotine tartrate, 75 parts of microcrystalline cellulose, 15 parts of konjac gum, 5 parts of peppermint flavor, 1 part of maltitol and 2 parts of mentholamide are placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed is 20 r / min and the time is 25 min to ensure that each component can be evenly dispersed, so that the mixing uniformity RSD is 2.4%, and the premixed material is the nicotine contents.

[0079] (3) Using existing fully automated nicotine bag production equipment, the nicotine contents obtained in step (2) above are filled into saliva-permeable pouches. The saliva-permeable pouches are made of food-grade non-woven fabric and are obtained after heat sealing and ultraviolet sterilization.

[0080] The nicotine content is 0.5 g, the heat-sealing temperature is 135℃, and the heat-sealing time is 0.8 s; the basis weight of the food-grade spunlace nonwoven fabric is 28 g / m². 2 It has a pore size of 32 μm, a thickness of 0.25 mm, and an air permeability of 1150 L / m³. 2 ·s.

[0081] Example 3

[0082] (1) Nicotine free base, microcrystalline cellulose, xanthan gum, lemon flavoring, sucralose and edible salt were passed through an 80-mesh sieve to obtain the corresponding pre-treated raw materials. The moisture content of the pre-treated raw materials was 4.2%.

[0083] (2) Taking 100 parts of nicotine contents as the mass, the above-mentioned pretreated raw materials: 3 parts of nicotine free base, 78 parts of microcrystalline cellulose, 12 parts of xanthan gum, 4 parts of lemon flavoring, 1 part of sucralose and 2 parts of edible salt are placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed is 18 r / min and the time is 30 min to ensure that each component can be evenly dispersed, so that the mixing uniformity RSD is 2.7%, and the premixed material is the nicotine contents.

[0084] (3) Using existing fully automated nicotine bag production equipment, the nicotine contents obtained in step (2) above are filled into saliva-permeable pouches. The saliva-permeable pouches are made of food-grade non-woven fabric and are obtained after heat sealing and ultraviolet sterilization.

[0085] The nicotine content is 0.5 g, the heat-sealing temperature is 140℃, and the heat-sealing time is 0.6 s; the basis weight of the food-grade spunlace nonwoven fabric is 30 g / m². 2 It has a pore size of 22 μm, a thickness of 0.30 mm, and an air permeability of 880 L / m³. 2 ·s.

[0086] Example 4

[0087] (1) Nicotine malate, microcrystalline cellulose, sodium carboxymethyl cellulose (CMC), peppermint flavor, sucralose and menthol were passed through an 80-mesh sieve to obtain pretreated raw materials of the corresponding components. The moisture content of the pretreated raw materials was found to be 4.2%.

[0088] (2) Taking 100 parts of nicotine contents as the mass, the above-mentioned pretreated raw materials: 5 parts of nicotine malate, 65 parts of microcrystalline cellulose, 20 parts of sodium carboxymethyl cellulose (CMC), 5 parts of peppermint flavoring, 2 parts of sucralose and 3 parts of menthol are placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed is 18 r / min and the time is 30 min to ensure that each component can be evenly dispersed, so that the mixing uniformity RSD is 2.7%, and the premixed material is the nicotine contents.

[0089] (3) Using existing fully automated nicotine bag production equipment, the nicotine contents obtained in step (2) above are filled into saliva-permeable pouches. The saliva-permeable pouches are made of food-grade non-woven fabric and are obtained after heat sealing and ultraviolet sterilization.

[0090] The nicotine content is 0.5 g, the heat-sealing temperature is 130℃, and the heat-sealing time is 1.0 s; the basis weight of the food-grade spunlace nonwoven fabric is 32 g / m². 2 It has a pore size of 18 μm, a thickness of 0.35 mm, and an air permeability of 920 L / m³. 2 ·s.

[0091] Comparative Example 1

[0092] Compared with Example 1, the difference is that the controlled-release agent in this comparative example is replaced with low-viscosity sodium carboxymethyl cellulose, i.e., the viscosity is: the dynamic viscosity of the paste formed within 20 s is 8000 mPa·s. The nicotine bag is prepared by the following method: (1) Nicotine malate, microcrystalline cellulose, low viscosity sodium carboxymethyl cellulose (CMC), peppermint flavor, sucralose and menthol were passed through an 80-mesh sieve to obtain the corresponding pre-treated raw materials. The moisture content of the pre-treated raw materials was found to be 4.2%.

[0093] (2) Taking 100 parts of nicotine contents as the mass, the above-mentioned pretreated raw materials: 4 parts of nicotine malate, 75 parts of microcrystalline cellulose, 15 parts of low viscosity sodium carboxymethyl cellulose (CMC), 3 parts of peppermint flavoring, 1 part of sucralose and 2 parts of menthol are placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed is 18 r / min and the time is 30 min to ensure that each component can be evenly dispersed, so that the mixing uniformity RSD is 2.7%, and the premixed material is the nicotine contents.

[0094] (3) Using existing fully automated nicotine bag production equipment, the nicotine contents obtained in step (2) above are filled into saliva-permeable pouches. The saliva-permeable pouches are made of food-grade non-woven fabric and are obtained after heat sealing and ultraviolet sterilization.

[0095] The nicotine content is 0.5 g, the heat-sealing temperature is 130℃, and the heat-sealing time is 1.0 s; the basis weight of the food-grade spunlace nonwoven fabric is 32 g / m². 2 It has a pore size of 18 μm, a thickness of 0.35 mm, and an air permeability of 920 L / m³. 2 ·s.

[0096] Comparative Example 2

[0097] Compared with Example 1, the difference is that the pore size of the nonwoven fabric in this comparative example is 70 μm, and the nicotine bag is prepared by the following method: (1) Nicotine malate, microcrystalline cellulose, sodium carboxymethyl cellulose (CMC), peppermint flavor, sucralose and menthol were passed through an 80-mesh sieve to obtain pretreated raw materials of the corresponding components. The moisture content of the pretreated raw materials was found to be 4.2%.

[0098] (2) Taking 100 parts of nicotine contents as the mass, the above-mentioned pretreated raw materials: 4 parts of nicotine malate, 75 parts of microcrystalline cellulose, 15 parts of sodium carboxymethyl cellulose (CMC), 3 parts of peppermint flavoring, 1 part of sucralose and 2 parts of menthol are placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed is 18 r / min and the time is 30 min to ensure that each component can be evenly dispersed, so that the mixing uniformity RSD is 2.7%, and the premixed material is the nicotine contents.

[0099] (3) Using existing fully automated nicotine bag production equipment, the nicotine contents obtained in step (2) above are filled into saliva-permeable pouches. The saliva-permeable pouches are made of food-grade non-woven fabric and are obtained after heat sealing and ultraviolet sterilization.

[0100] The nicotine content is 0.5 g, the heat-sealing temperature is 130℃, and the heat-sealing time is 1.0 s; the basis weight of the food-grade spunlace nonwoven fabric is 32 g / m². 2 It has a pore size of 70 μm, a thickness of 0.35 mm, and an air permeability of 920 L / m³. 2 ·s.

[0101] Comparative Example 3

[0102] Compared with Example 1, the difference is that this comparative example uses the product formula of commercially available nicotine bags. The mass of the contents of the nicotine bag is 100 parts, including 4 parts of nicotine salt, 88 parts of microcrystalline cellulose, and 8 parts of flavoring agent. The non-woven fabric has a pore size of 40 μm and no pore size-controlled release agent matching design to prepare the nicotine bag.

[0103] Comparative Example 4

[0104] Compared with Example 1, the difference is that this comparative example uses the method described in Example 1 of the patent document with publication number CN121128957A to prepare nicotine bags. The nicotine bags include contents and outer packaging. The contents include nicotine source, pH adjuster, filler, excipient, sweetener and flavoring. The outer packaging is a saliva-permeable pouch.

[0105] Test Example 1: Nicotine Dissolution Test

[0106] To further illustrate the advantages of the preparation method described in the embodiments of this application, the nicotine dissolution test was conducted on the nicotine bags prepared in Examples 1-4 and Comparative Examples 1-4 using a dissolution apparatus-paddle method. Simulated artificial saliva was used as the dissolution medium, with a pH of 6.8. The dissolution of nicotine in the nicotine bags was detected within 5-60 minutes at a temperature of 37±0.5℃ and a rotation speed of 50 r / min.

[0107] The results are shown in Table 1. The nicotine leaching from the nicotine bags of Examples 1-4 showed a significantly more stable release compared to the nicotine leaching from the nicotine bags of Comparative Examples 1-4. However, since the nicotine release from the nicotine bag of Example 4 is similar to that of the nicotine bag of Example 1, and the nicotine release from the nicotine bag of Comparative Example 4 is similar to that of the nicotine bag of Comparative Example 3, Examples 4 and Comparative Example 4 will not be further described in Table 1 and the results description.

[0108] The nicotine bag in Example 1 showed a cumulative nicotine release rate of 14.8% within 5 minutes, 38.2% within 10 minutes, an effective nicotine release rate of 92.7% at 30 minutes, and an effective nicotine release rate of 99.1% at 60 minutes.

[0109] The nicotine bag in Example 2 showed a cumulative nicotine release rate of 10.3% within 5 minutes, 34.7% within 10 minutes, an effective nicotine release rate of 90.2% at 30 minutes, and an effective nicotine release rate of 98.4% at 60 minutes.

[0110] The nicotine bag in Example 3 showed a cumulative nicotine release rate of 12.6% within 5 minutes, 36.1% within 10 minutes, an effective nicotine release rate of 91.8% at 30 minutes, and an effective nicotine release rate of 98.7% at 60 minutes.

[0111] In summary, the nicotine contents in the nicotine bags prepared in Examples 1-3 can form a stable paste-like membrane, with no initial burst of nicotine release, a stable release rate, and low irritation.

[0112] In Comparative Example 1, the nicotine bag achieved a cumulative nicotine release rate of 62.7% within 5 minutes, 85.3% within 10 minutes, and an effective nicotine release rate of 94.2% after 30 minutes. Compared to Examples 1-3, the viscosity of the controlled-release agent in the nicotine contents of the nicotine bag in Comparative Example 1 was lower. During the dissolution test, it was unable to form a paste-like membrane within the nicotine bag, leading to a severe initial nicotine burst. These results further confirm that the viscosity of the controlled-release agent in the nicotine contents of the nicotine bag plays a crucial role in the nicotine release rate. When the viscosity of the controlled-release agent is lower than the standard defined in this application, the nicotine contents cannot effectively form a paste-like membrane to control the release rate, thus triggering a severe initial nicotine burst, resulting in significantly increased oral irritation and a marked decrease in product comfort.

[0113] In Comparative Example 2, the nicotine bag achieved a cumulative nicotine release rate of 58.4% within 5 minutes, 82.6% within 10 minutes, and an effective nicotine release rate of 93.7% after 30 minutes. Compared to Examples 1-3 above, the nicotine bag in Comparative Example 2 had excessively large pore sizes in its nonwoven fabric, causing a significant loss of nicotine contents through the pores. Simultaneously, the controlled-release agent also leaked out, failing to form a stable membrane within the nicotine bag, thus leading to a severe initial burst of nicotine release. The above results further confirm that the pore size of the saliva-permeable pouch in the nicotine pouch has a crucial impact on the nicotine release rate. When the pore size is larger than the standard defined in this application, a large amount of nicotine content is lost, and a paste-like membrane cannot be effectively formed to control the release rate, thereby causing severe initial nicotine burst release, resulting in significantly enhanced oral irritation and a marked decrease in product comfort. In other words, when the pore size is smaller than the standard defined in this application, although a paste-like membrane can be formed in the nicotine pouch to control the release rate and avoid initial burst release, the nicotine release rate is too low, and an effective nicotine concentration cannot be achieved in the short term during the initial use, making it difficult for users to obtain the expected satisfaction and pleasure in a short period of time, and significantly reducing product attractiveness and user compliance.

[0114] In Comparative Example 3, the nicotine pouch achieved a cumulative nicotine release rate of 74.6% within 5 minutes, 89.2% within 10 minutes, and an effective nicotine release rate of 92.1% after 30 minutes. Compared to Examples 1-3, the nicotine pouch in Comparative Example 3 still exhibited severe initial burst release, and this initial burst release was significantly increased compared to Comparative Examples 1-2. This indicates that by synergistically limiting parameters such as the viscosity of the controlled-release agent within the nicotine pouch and the pore size of the saliva-permeable pouch, this application can effectively prevent initial burst release of nicotine, ensuring a continuous release of nicotine at an appropriate rate. This approach guarantees user comfort while providing the expected satisfaction, thus addressing the pain point of initial burst release of nicotine in nicotine pouches in the industry.

[0115] Table 1. Statistical table of nicotine leaching from nicotine bags in different embodiments and comparative examples.

[0116] Therefore, it can be concluded that this application provides a dynamic diaphragm controlled-release nicotine bag and its preparation method. After the controlled-release agent inside the nicotine bag comes into contact with saliva, a paste-like diaphragm is formed in real time on the inner side of the non-woven fabric. The nicotine release rate is determined by the dissolution rate of the diaphragm, and the nicotine is released slowly through the repetitive process of "diaphragm formation-dissolution-reformation". This fundamentally solves the industry problem of "initial burst release stimulation and insufficient release in the later stage" in existing nicotine bags, and achieves uniform and gradient controllable release of nicotine throughout the process, further improving the overall taste experience for users and simplifying the production process of nicotine bags.

[0117] In the foregoing description of exemplary embodiments / specific implementations of this application, various features of this application are sometimes combined in a single embodiment / specification or its figures and description, with the aim of simplifying the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, the descriptive approach of this application should not be construed as reflecting an intention that the claimed features are more than expressly stated in each claim, except where expressly stated otherwise or in obvious technical contradictions or exclusions are found. Rather, the inventive aspects reflected in the claims lie in not all features of a single foregoing disclosed embodiment / specification. Therefore, the claims following the detailed description are hereby expressly incorporated into this detailed description, each claim existing independently as a separate embodiment / specification of this application.

[0118] The terms and expressions used in this specification are illustrative and not limiting. Their use is not intended to exclude any equivalents of the shown and described features or portions thereof, but rather to facilitate the understanding that various modifications may be possible within the scope of the claims. Therefore, it should be understood that while this application has been specifically disclosed through preferred embodiments, exemplary embodiments, and optional features, variations or modifications of the concepts disclosed herein may be adopted by those skilled in the art, and such variations and modifications are therefore considered to be within the scope of this application as defined by the appended claims. The specific embodiments given in this specification are examples of useful embodiments of this application, and it will be apparent to those skilled in the art that this application can be implemented using many variations of the devices, device components, and method steps disclosed herein.

[0119] The foregoing description of specific embodiments has fully disclosed the general features of this application, enabling others to easily modify and / or adapt such embodiments for various applications by applying knowledge within the scope of the art, without excessive experimentation or deviation from the general concept of this application. Therefore, based on the teachings and guidance provided herein, it is intended that such modifications and alterations be included within the meaning and scope of equivalents of the disclosed embodiments. It should be understood that the wording or terminology used herein is for descriptive purposes and is not intended to be limiting; thus, the wording or terminology in this specification will be interpreted by those skilled in the art based on the foregoing teachings and guidance.

[0120] Furthermore, the scope of this application should not be limited to any of the exemplary embodiments described above, but only to the appended claims and their equivalents.

Claims

1. A dynamic diaphragm controlled-release nicotine bag, characterized in that, The dynamic diaphragm controlled-release nicotine bag includes nicotine contents and a saliva-permeable pouch; The nicotine contents include a nicotine source and a controlled-release agent. The controlled-release agent swells within the saliva-permeable pouch within 20 seconds of contact with water or saliva, causing the nicotine contents to form a viscous paste-like membrane. The release rate of the nicotine source is controlled by the dissolution rate of the paste-like membrane. The nicotine source cannot be rapidly released through the paste-like membrane and the saliva-permeable pouch, thus avoiding a burst release of the nicotine source at the initial stage of consumption. The dynamic viscosity of the paste-like membrane is ≥20000 mPa·s, and the cumulative time for the paste-like membrane formed by the nicotine contents to completely dissolve in saliva is ≥30 min.

2. The dynamic diaphragm controlled-release nicotine bag according to claim 1, characterized in that, The saliva-permeable pouch comprises food-grade non-woven fabric; The pore size of the food-grade nonwoven fabric is 10-20 μm, 20-25 μm, 25-30 μm, 30-35 μm or 35-50 μm; The air permeability of the food-grade nonwoven fabric is 800-900 L / m. 2 ·s、900-1100 L / m 2 ·s or 1100-1200 L / m 2 ·s; This prevents the nicotine contents from leaking through the pores of the saliva-permeable pouch before forming the paste-like diaphragm.

3. The dynamic diaphragm controlled-release nicotine bag according to claim 2, characterized in that, The weight of the food-grade nonwoven fabric is 25-30 g / m². 2 30-32 g / m 2 Or 30-35 g / m 2 ; The thickness of the food-grade nonwoven fabric is 0.20-0.22 mm, 0.22-0.26 mm, 0.26-0.28 mm, 0.28-0.30 mm, 0.30-0.33 mm or 0.33-0.36 mm.

4. The dynamic diaphragm controlled-release nicotine bag according to claim 3, characterized in that, The nicotine contents also include fillers and flavorings; based on 100 parts by weight of the nicotine contents, it includes: The nicotine source is present in amounts of 0.1-1.0 parts, 1.0-2.0 parts, 2.0-3.0 parts, or 3.0-5.0 parts; The filler is 65-70 parts, 70-75 parts, or 75-80 parts; The controlled-release agent is 3-5 parts, 5-10 parts, or 10-20 parts; The seasoning is 1-3 parts; 3-8 parts; or 8-12 parts.

5. The dynamic diaphragm controlled-release nicotine bag according to claim 4, characterized in that, The controlled-release agent includes one or more combinations of cellulose ethers, natural plant gums, pregelatinized starch, or sodium alginate. The cellulose ethers include one or more combinations of hydroxyethyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, or hydroxypropyl cellulose; the natural plant gums include one or more combinations of xanthan gum, guar gum, locust bean gum, carrageenan, gum arabic, or konjac gum.

6. The dynamic diaphragm controlled-release nicotine bag according to claim 5, characterized in that, The nicotine source includes one or more combinations of nicotine salts, nicotine free bases, or tobacco extracts; The nicotine salts include nicotine hydrochloride, nicotine dihydrochloride, nicotine phosphate, nicotine sulfate, nicotine tartrate, nicotine tartrate dihydrate, nicotine pyruvate, nicotine formate, nicotine oxalate, nicotine ascorbate, nicotine glycolate, nicotine acetate, nicotine isovalerate, nicotine valerate, nicotine propionate, nicotine caprylate, nicotine lactate, nicotine acetylpropionate, nicotine sorbate, nicotine malate, nicotine fumarate, nicotine salicylate, nicotine glycinate, nicotine tartrate, nicotine succinate, nicotine citrate, and nicotine succinate. The nicotine benzoate, nicotine resinate, nicotine oleate, nicotine aconitate, nicotine butyrate, nicotine cinnamate, nicotine caprate, nicotine 3,7-dimethyl-6-octenate, nicotine 1-glutamate, nicotine heptamate, nicotine hexanoate, nicotine 3-hexenoate, nicotine trans-2-hexenoate, nicotine isobutyrate, nicotine laurate, nicotine 2-methylbutyrate, nicotine 2-methylvalerate, nicotine myristate, nicotine nonanoate, nicotine palmitate, nicotine 4-pentenoate, nicotine phenylacetate, or nicotine 3-phenylpropionate, or one or more combinations thereof.

7. The dynamic diaphragm controlled-release nicotine bag according to claim 4, characterized in that, The filler includes microcrystalline cellulose; The flavoring agent includes one or more of the following: flavorings, flavoring agents, and cooling agents; the flavorings are present in a mass fraction of 3-6 parts, the flavoring agents in a mass fraction of 1-3 parts, and the cooling agents in a mass fraction of 1-3 parts. The flavorings include one or more combinations of food-grade peppermint flavoring, fruit flavoring, herbal flavoring, or tobacco flavoring; the flavoring agents include one or more combinations of edible salt, steviol glycosides, sucralose, neotame, aspartame, acesulfame potassium, cyclamate, sodium saccharin, sodium cyclohexylsulfamate, disodium glycyrrhizate, or tripotassium and trisodium glycyrrhizate; the cooling agents include one or more combinations of menthol, mentholamide, or W23.

8. The dynamic diaphragm controlled-release nicotine bag according to any one of claims 1-7, characterized in that, The amount of nicotine contents in the nicotine bag is 0.1-0.3 g, 0.3-0.4 g, or 0.4-0.5 g, such that the cumulative release rate of the nicotine source in the nicotine bag is 10-20% in the first 0-5 minutes, 30-50% in the first 5-10 minutes, and ≥90% in the last 30 minutes.

9. A method for preparing a dynamic diaphragm controlled-release nicotine bag as described in claim 8, characterized in that, Includes the following steps: Step A: Pre-treat the nicotine source, controlled-release agent, filler, and flavoring agent by passing them through an 80-100 mesh sieve to obtain pre-treated nicotine source, pre-treated controlled-release agent, pre-treated filler, and pre-treated flavoring agent, respectively. Step B: Mix the pretreated nicotine source, the pretreated controlled-release agent, the pretreated filler, and the pretreated flavoring agent in a mass ratio of (1-5):(3-20):(65-80):(1-12). The amount of pretreated controlled-release agent, pretreated filler, and pretreated flavoring agent increases with the amount of pretreated nicotine source added, to obtain the nicotine contents. Step C: Fill the nicotine contents into the saliva-permeable pouch, and obtain the nicotine pouch after heat sealing and ultraviolet sterilization.

10. The preparation method according to claim 9, characterized in that, In step B, the mixing uniformity of the nicotine contents is 2.0-2.2%, 2.2-2.5%, or 2.5-3.0%. In step C, the heat-sealing temperature is 130-140℃, 140-145℃, or 145-150℃, and the heat-sealing time is 0.5-0.7 s, 0.7-0.8 s, or 0.8-1.0 s; the material of the saliva-permeable pouch includes one or more combinations of polypropylene fiber, polyester fiber, polyamide fiber, polytetrafluoroethylene fiber, and glass fiber.

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