Buccal product and preparation method thereof
By using a dual antioxidant system of β-glucan and antioxidants in oral products, the oxidation problem of oral products during storage and use is solved, and the stability of active substances and the taste are improved.
Patent Information
- Application Number
- CN202510698498.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-05-28
- Publication Date
- 2025-10-21
AI Technical Summary
Existing oral products are prone to generating undesirable chemicals due to oxidation reactions during storage and use, leading to taste and safety issues.
β-glucan is used as the first embedding layer to isolate the active substance from the external environment through a physical barrier. It is combined with antioxidants such as vitamin C and its derivatives, rosemary extract, tea polyphenols, etc. to form a dual antioxidant system to reduce the risk of oxidation.
Significantly slows down the oxidation rate of active substances, improves product stability and safety, improves taste, and enhances user experience.
Smart Images
Figure CN120814666A_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of smokeless products, and in particular to an oral product and a preparation method thereof. Background Art
[0002] Oral products come in a variety of flavors and can be used to replace traditional nicotine intake methods, achieving smoke-free use. Common oral products include orally disintegrating films, nicotine pouches, and lozenges.
[0003] However, existing oral products are susceptible to oxidation during storage and use due to exposure to air and humidity, producing undesirable chemicals such as amines and aldehydes. Therefore, developing a formulation and packaging technology that can significantly slow the oxidation process of oral products has become a pressing issue. Summary of the Invention
[0004] The embodiments of the present application provide an oral product and a preparation method thereof, which can slow down the oxidation rate of the core material of the oral product by embedding the core material of the oral product.
[0005] The embodiment of the present application provides an oral product, which comprises: a first embedding material, a filler and an antioxidant, wherein:
[0006] The first embedding material includes an active substance and a first embedding layer, the first embedding layer is used to coat the active substance to isolate the active substance from the outside of the first embedding layer, and the first embedding layer includes β-glucan.
[0007] In some embodiments, the antioxidant is coated on the outer layer of the first embedding object.
[0008] In some embodiments, the antioxidant includes at least one of vitamin C and its derivatives, rosemary extract, tea polyphenols, citric acid, and vitamin E.
[0009] In some embodiments, the oral product further comprises a hygroscopic agent, which is used to control the humidity of the oral product. The hygroscopic agent comprises at least one of silica gel powder and montmorillonite.
[0010] In some embodiments, the oral product further comprises at least one of a pH adjuster, a sweetener, a flavor, and a binder.
[0011] In some embodiments, the active substance comprises at least one of nicotine and a nicotine derivative; and / or,
[0012] The filler comprises at least one of modified microcrystalline cellulose and polyvinyl alcohol; and / or,
[0013] The pH regulator includes at least one of sodium carbonate, sodium bicarbonate, citric acid, and sodium citrate; and / or,
[0014] The sweetener includes at least one of aspartame, neotame, acesulfame potassium, sucralose, and steviol glycosides; and / or,
[0015] The adhesive includes at least one of sodium alginate and starch.
[0016] In some embodiments, the oral preparation includes, measured by mass, 0.1-4 parts of active substance, 1-30 parts of first embedding layer, 0.2-3 parts of antioxidant, 50-75 parts of filler, 1-3 parts of hygroscopic agent, 1-20 parts of pH adjuster, 0.1-30 parts of sweetener, 5-8 parts of adhesive, and 3-8 parts of flavors and fragrances.
[0017] In some embodiments, the oral product further comprises a permeable pouch that is permeable to saliva.
[0018] The present invention also provides a method for preparing an oral product, which is used to prepare the oral product as described above, comprising:
[0019] Obtaining a carrier solution comprising β-glucan, adding an active substance to the carrier solution, and then granulating to obtain a first embedding material, wherein the first embedding material comprises the active substance and a first embedding layer, and the first embedding layer comprises β-glucan;
[0020] The first embedding material is mixed with a filler and an antioxidant to prepare the oral product.
[0021] In some embodiments, the step of mixing the first embedding material with a filler and an antioxidant to prepare the oral product comprises:
[0022] obtaining an antioxidant solution containing an antioxidant, and coating the first embedding object with the antioxidant solution to obtain an antioxidant embedding object;
[0023] The filler and the antioxidant embedding material are added to a solvent and mixed, and then extruded and formed, and dried and crushed to obtain the oral product.
[0024] The beneficial effects of the present application are as follows: the present application uses β-glucan as the first embedding layer for the active substance to isolate the active substance from contact with the outside of the first embedding layer, that is, it can effectively isolate the active substance from contact with the external air, and reduce the risk of oxidation of the active substance through physical barrier protection. At the same time, β-glucan has certain antioxidant properties, and by adding antioxidants and utilizing the characteristics of antioxidants, the oxidation of the oral preparation can be further reduced. The dual antioxidant mechanisms can effectively slow down the oxidation rate of the active substance. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.
[0026] Figure 1 This is a schematic diagram of the structure of the oral product according to one embodiment of the present application;
[0027] Figure 2 This is a schematic diagram of the structure of the oral product in another embodiment of the present application;
[0028] Figure 3 This is a preparation flow chart of an embodiment of the present application;
[0029] Figure 4 This is a preparation flow chart of another embodiment of the present application.
[0030] Explanation of the reference numerals: 10 - first embedding substance; 20 - antioxidant embedding substance; 100 - active substance; 200 - first embedding layer; 300 - second embedding layer. DETAILED DESCRIPTION
[0031] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.
[0032] First, referring to the aforementioned background art, while oxidation processes can be controlled to some extent during production, they cannot be completely avoided. Developing a formulation and packaging technology that can significantly slow nicotine oxidation has become a pressing issue. Therefore, to address this issue, this application provides the following embodiments.
[0033] Please refer to Figure 1 One embodiment of the present application provides an oral product, which includes: a first embedding material 10, a filler and an antioxidant, wherein the first embedding material 10 includes an active substance 100 and a first embedding layer 200, and the first embedding layer 200 is used to encapsulate the active substance 100 to isolate the active substance 100 from the outside of the first embedding layer 200, that is, to effectively isolate the active substance 100 from contact with the external air, and the first embedding layer 200 includes β-glucan.
[0034] In this embodiment, the active substance 100 in the first embedded material 10 is described as a neuromodulator. In one embodiment, the active substance 100 is a natural alkaloid, such as nicotine or nornicotine. In another embodiment, the active substance 100 is a synthetic derivative, such as a nicotine salt or a structural analogue, wherein nicotine salts include nicotine citrate and structural analogues include vilantrine. In yet another embodiment, the active substance 100 is a plant extract, such as a nicotine-containing tobacco extract or other Solanaceae plant extract. In this embodiment, the active substance 100 is capable of releasing nicotine upon use.
[0035] In some embodiments, the active substance may also be an active substance with specific medical properties. In some embodiments, the active substance may also be other active substances with specific properties, such as caffeine, capsaicin, theophylline, etc., to meet different user needs.
[0036] In this embodiment, β-glucan refers to a type of soluble β-glucan extracted from cereals (such as oats, barley, rye, corn, etc.) or other plants. In another embodiment, the cereal extract is oat β-glucan, which has strong antioxidant properties. In this embodiment, β-glucan is used as the microcapsule wall material of active substance 100.
[0037] In this embodiment, β-glucan is a natural polysaccharide with certain antioxidant properties. It is soluble in water to form a viscous solution. Furthermore, the molecular chains of β-glucan form a three-dimensional network structure through hydrogen bonding or hydrophobic interactions, which can encapsulate the active substance 100 and form a dense film on the surface of the active substance 100, forming a physical protective barrier and reducing the oxidation rate of the oral product before use. β-glucan can also be degraded by the human body and microorganisms, thus ensuring safety and environmental protection.
[0038] In this embodiment, β-glucan is used as the first embedding layer 200 in the first embedding material to embed the active substance 100. In addition to the antioxidant properties of β-glucan itself, β-glucan can isolate the active substance 100 from contact with external substances, thereby improving the antioxidant capacity of the oral product and reducing oxidation caused by direct exposure of the active substance 100 in the oral product. At the same time, β-glucan can also gradually release the embedded active substance 100 under specific pH or enzymatic hydrolysis conditions, thereby controlling the sustained release of the active substance 100. In addition, the non-toxic nature of β-glucan as the first embedding layer 200 can improve the safety of the oral product and reduce the risk of the oral product.
[0039] In one embodiment, β-glucan is coated on the surface of the active material 100 by an encapsulation technique.
[0040] In this embodiment, the filler can be used as a substance that provides support and filling capabilities in the oral product, can provide sufficient support capacity for the oral product, and enable the first embedding layer 200 to better cover the active substance.
[0041] In this embodiment, the addition of an antioxidant to the oral product can further enhance its antioxidant properties. In this embodiment, the antioxidant, when mixed with the first embedding material 100, can reduce the oxidation rate of the first embedding material 100, inhibiting oxidation of the first embedding material 100. This, in turn, allows the first embedding material 100 to maintain its structural integrity and physical properties, ensuring its long-term stability and effectiveness.
[0042] Please continue to refer to Figure 1 In one embodiment, the antioxidant is coated on the outer layer of the first embedding material.
[0043] In this embodiment, the antioxidant can serve as the second embedding layer 300 of the active material 100, further coating the surface of the first embedding layer 200 to obtain the antioxidant embedding material 20. In this case, the antioxidant coats the surface of the first embedding material 10. In this manner, the surface of the active material 100 comprises two embedding layers, including the first embedding layer 200 and the second embedding layer 300. In this embodiment, the first embedding layer 200 is provided, and the β-glucan in the first embedding layer 200 can embed the active material 100 to form a dense polysaccharide network, thereby forming a physical protective barrier, thereby isolating the active material 100 from oxidative stimulation from external environmental factors such as oxygen and metal ions. In this embodiment, the second embedding layer 300 is provided, and the antioxidant in the second embedding layer 300 can directly scavenge free radicals or block oxidative chain reactions by providing electrons or hydrogen atoms, thereby reducing oxidation of internal substances. Therefore, in this embodiment, the dual antioxidant system of the physical barrier of the first embedding layer 200 and the chemical defense of the second embedding layer 300 can be combined to achieve antioxidant effect through different mechanisms, further improving the stability of the active substance and further slowing down the oxidation rate of the active substance.
[0044] Specifically, antioxidants are a class of substances that can inhibit or delay oxidation reactions. They protect active ingredients by scavenging free radicals, blocking chain reactions, or chelating metal ions, thereby helping the active substance 100 reduce the risk of oxidation and retain and protect its activity.
[0045] In one embodiment, the antioxidant includes at least one of vitamin C and its derivatives, rosemary extract, tea polyphenols, citric acid, and vitamin E.
[0046] In one example, the antioxidant is a natural antioxidant, such as vitamin C, vitamin E, polyphenols (such as tea polyphenols, resveratrol), carotenoids (such as lycopene, β-carotene), etc. In another embodiment, the antioxidant is a synthetic antioxidant, such as butylated hydroxyanisole or butylated hydroxytoluene, etc. In yet another embodiment, the antioxidant is an enzyme antioxidant, such as superoxide dismutase or glutathione peroxidase, etc.
[0047] In another example, three antioxidants may be included: the first being a mixture of one or more of vitamin E, rosemary extract, and tea polyphenols; the second being a mixture of one or more of citric acid and sodium ascorbate; and the third being a combination of the first and second antioxidants. In this embodiment, each of the three antioxidants can be independently combined with the first embedding material in the manner described above, i.e., can be provided as the second embedding layer 300 covering the first embedding material, or can be provided as a mixture with the first embedding material.
[0048] In another example, the antioxidant includes a primary antioxidant and a secondary antioxidant, wherein the primary antioxidant is one or a mixture of vitamin E, rosemary extract, and tea polyphenols. The secondary antioxidant is one or a mixture of citric acid and sodium ascorbate. The combination of these two antioxidants with the first embedding material can further enhance the antioxidant properties of the oral product.
[0049] In another example, the antioxidant comprises a combination of any of the three aforementioned examples and citric acid. In this example, citric acid is a relatively weak antioxidant that forms chelates with metal ions, thereby enhancing the antioxidant properties of antioxidants such as vitamin C and tea polyphenols. Furthermore, citric acid enables the antioxidant to be stably coated on the surface of the first embedding material to form the second embedding layer 300, thereby enhancing the structural stability of the antioxidant as the second embedding layer 300 and thereby increasing the strength of the second embedding layer 300.
[0050] In one embodiment, the first embedding layer 200 and the second embedding layer 300 can be prepared by embedding technology.
[0051] In one embodiment, the oral product further includes a hygroscopic agent, which is used to control the humidity of the oral product. The hygroscopic agent includes at least one of silica gel powder and montmorillonite.
[0052] In this embodiment, the function of the hygroscopic agent is to absorb excess moisture in the oral product packaging to reduce the occurrence of oxidative conditions, thereby further enhancing the anti-oxidative properties of the oral product.
[0053] In this embodiment, silica gel powder and / or montmorillonite are used as hygroscopic substances, which can absorb moisture in the oral product by physical adsorption, maintain a dry environment in the bag, thereby preventing the components in the oral product from clumping, avoiding the internal substances from sticking together due to moisture absorption, and ensuring the uniform texture of the oral product. At the same time, it can extend the shelf life and control the release performance of the stable active substance 100.
[0054] In one embodiment, the oral preparation further comprises at least one of a pH adjuster, a sweetener, a flavor, and a binder.
[0055] In this embodiment, the pH adjuster, sweetener, flavor, and adhesive are all mixed with the first embedding material 10 or the antioxidant embedding material 20 in other embodiments.
[0056] In this embodiment, the pH adjuster is used to adjust the pH value of the active substance 100 so as to increase the proportion of the non-ionic state of the active substance 100 , thereby improving the utilization and absorption efficiency of the active substance 100 .
[0057] In this embodiment, the sweetener is used to provide sweetness to the oral preparation and matches the sustained-release effect of the active substance 100 to improve the taste of the oral preparation and enhance the user experience.
[0058] In this embodiment, flavors and fragrances are used to enrich the taste of the oral product. Furthermore, since active substances 100, such as nicotine, inherently have a bitter and pungent taste, flavors and fragrances can effectively mask these negative taste experiences by providing a rich flavor, such as mint, fruit, or herbal aroma, thereby improving the mouthfeel, masking unpleasant tastes, and enhancing the user experience.
[0059] In this embodiment, the adhesive is used to maintain the physical stability of the oral product and can bind other substances in the oral product. Furthermore, the adhesive has swelling and slow solubility, which can slow the release rate of the active substance 100 and prolong its duration of action. Furthermore, the adhesive can give the active substance 100 a soft or slightly elastic texture, reducing the gritty feel of the oral product during use. Furthermore, the adhesive can serve as a carrier for pH regulators, flavors, fragrances, or sweeteners, ensuring uniform distribution and simultaneous release of the various substances in the oral product.
[0060] In one embodiment, the active substance 100 includes at least one of nicotine and a nicotine derivative. Nicotine includes natural nicotine and synthetic nicotine. Nicotine derivatives include one or more of nicotine salts, nicotine in a matrix (such as a sugar matrix) or an organometallic complex, a nicotine-resin composition, a nicotine inclusion complex, and non-covalently bound nicotine. Non-covalently bound nicotine includes nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin inclusion complex, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, nicotine benzoate, and the like. Nicotine derivatives also include nicotine containing substituents, such as hexamethyl nicotine, hexamethyl nicotine lactate, hexamethyl nicotine malate, hexamethyl nicotine salicylate, hexamethyl nicotine cyclodextrin embedded complex, hexamethyl nicotine hydrochloride, hexamethyl nicotine dihydrochloride, hexamethyl nicotine tartrate, hexamethyl nicotine tartrate dihydrate, hexamethyl nicotine sulfate, hexamethyl nicotine zinc chloride, and hexamethyl nicotine benzoate. One or more mixtures thereof.
[0061] In some embodiments, the active substance 100 may be an active substance with specific medical properties; the active substance 100 may also be other active substances with specific properties, such as caffeine, theophylline, capsaicin, etc., to meet different user needs.
[0062] In one embodiment, the filler comprises at least one of modified microcrystalline cellulose and polyvinyl alcohol. The modified microcrystalline cellulose can provide structural support and good flowability as a filler, while the polyvinyl alcohol can enhance the strength and moisture retention of the oral product.
[0063] In one embodiment, the pH adjuster includes at least one of sodium carbonate, sodium bicarbonate, citric acid, and sodium citrate. Sodium bicarbonate can optimize the release and absorption of the active substance 100 by increasing the alkalinity (pH 8-9) of the oral product environment. It can also promote the conversion of nicotine into a free state, thereby improving the mouthfeel of the oral product and making it milder. Furthermore, sodium bicarbonate can stabilize the release rate, preventing premature or delayed release due to pH fluctuations.
[0064] In one embodiment, the sweetener includes at least one of aspartame, neotame, acesulfame potassium, sucralose, and steviol glycosides. Aspartame is characterized by its high sweetness, providing significant sweetness at low dosages. Neotame has high sweetness and strong stability. Acesulfame potassium can synergistically enhance sweetness, offering a refreshing sweetness without aftertaste and is resistant to high temperatures and acid and alkali. Sucralose offers excellent stability, a pure sweetness, is calorie-free, and does not react with nicotine. Steviosides are naturally derived from stevia and have a moderate sweetness.
[0065] In one embodiment, the binder includes at least one of sodium alginate and starch.
[0066] In one embodiment, the oral product further comprises a permeable bag permeable to saliva, wherein the permeable bag is the outermost structure of the oral product and is used to package the above-mentioned substances, making it an oral product that is easy to carry and use.
[0067] In one embodiment, the oral product is a nicotine pouch. In another embodiment, the permeable pouch is made of non-woven fabric. The non-woven fabric is breathable and moisture-permeable, maintaining the shape of the oral product while remaining non-reactive with the active substance 100, ensuring the safety and stability of the oral product.
[0068] In some embodiments, the oral product may also be an orally dissolving film, an oral tablet, a chewing gum, or other products in other forms.
[0069] Some examples are provided below to introduce the specific components of the oral preparation:
[0070] In one embodiment, the oral preparation includes, by weight percentage, 0.1-4 parts of active substance 100, 1-30 parts of first embedding layer 200, 0.2-3 parts of antioxidant (or 0.5-2 parts of antioxidant), 50-75 parts of filler, 1-3 parts of hygroscopic agent, 1-20 parts of pH regulator, 0.1-30 parts of sweetener, 5-8 parts of adhesive (or 2-12 parts of adhesive), and 3-8 parts of flavors and fragrances.
[0071] In one embodiment, the first embedded material of the active substance 100 after being embedded in β-glucan is 5 to 15 parts by mass.
[0072] In one embodiment, the filler comprises, by weight, 40-60 parts of modified microcrystalline cellulose and 10-15 parts of polyvinyl alcohol. In another embodiment, 50-75 parts of the filler comprises, by weight, 40-50 parts of modified microcrystalline cellulose and 10-15 parts of polyvinyl alcohol. In yet another embodiment, 50-75 parts of the filler comprises, by weight, 45-60 parts of modified microcrystalline cellulose and 10-15 parts of polyvinyl alcohol.
[0073] In one embodiment, the antioxidant comprises, by weight, 0.5-2 parts of one or a mixture of more than one of vitamin E, rosemary extract, and tea polyphenols; and 0.2-1 part of one or a mixture of citric acid and sodium ascorbate.
[0074] In one embodiment, the moisture absorbent comprises, by weight, 1 to 3 parts of silica gel powder or montmorillonite.
[0075] In one embodiment, the solvent comprises, by weight, 8 to 12 parts of water and 2 to 3 parts of glycerol.
[0076] Next, the specific components of the oral preparation are optimized in detail. In one embodiment, the oral preparation includes, by mass, the following: a filler (including 54.2 parts of modified microcrystalline cellulose and 12 parts of polyvinyl alcohol); 10 parts of a first embedding material; an antioxidant (including 1.5 parts of vitamin E, 1 part of tea polyphenols, and 5-10 parts of citric acid); a hygroscopic agent (including 2 parts of silica gel powder); a pH regulator (including 1 part of sodium bicarbonate); a sweetener (including 0.3 parts of acesulfame potassium); a binder (including 3 parts of sodium alginate); a flavoring agent (including 5 parts of essence); and a solvent (including 10 parts of water and 2 parts of glycerin).
[0077] In another embodiment, the oral preparation includes, by mass, the following: a filler (including 54.9 parts of modified microcrystalline cellulose and 10 parts of polyvinyl alcohol); 8 parts of a first embedding material; an antioxidant (including 2 parts of vitamin E, 1 part of tea polyphenols, and 5-10 parts of citric acid); a hygroscopic agent (including 2 parts of silica gel powder); a pH regulator (including 2 parts of sodium bicarbonate); a sweetener (including 0.1 parts of acesulfame potassium); a binder (including 2 parts of sodium alginate); a flavoring agent (including 6 parts of essence); and a solvent (including 10 parts of water and 2 parts of glycerin).
[0078] In another embodiment, the oral preparation includes, by mass, the following: a filler (including 45.8 parts of modified microcrystalline cellulose and 10 parts of polyvinyl alcohol); 15 parts of a first embedding material; an antioxidant (including 1 part of vitamin E, 1 part of tea polyphenols, and 5-10 parts of citric acid); a hygroscopic agent (including 3 parts of montmorillonite); a pH regulator (including 1 part of sodium bicarbonate); a sweetener (including 0.2 parts of acesulfame potassium); a binder (including 3 parts of sodium alginate); a flavoring agent (including 8 parts of essence); and a solvent (including 10 parts of water and 2 parts of glycerol).
[0079] In another embodiment, the oral preparation includes, by mass, the following: a filler (including 46.8 parts of modified microcrystalline cellulose and 13 parts of polyvinyl alcohol); 5 parts of a first embedding material; a hygroscopic agent (including 2 parts of silica gel powder); a pH regulator (including 2 parts of sodium bicarbonate); a sweetener (including 0.2 parts of acesulfame potassium); a binder (including 12 parts of sodium alginate); a flavoring agent (including 5 parts of essence); and a solvent (including 10 parts of water and 2 parts of glycerol).
[0080] In one embodiment, the β-glucan is 2.5% (w / v) food-grade oat β-glucan, wherein w / v is weight / volume percentage, ie, the percentage of solute mass to the total volume of the solution.
[0081] In one embodiment, the mass ratio of the flavor to the filler is 1:7 to 1:8.
[0082] In this embodiment, the oral product using the above structure has a relatively stable antioxidant capacity, and through the combined design of the antioxidant structure of the above antioxidant, the barrier structure of the first embedding layer 200, and the specific embedding technology, it can significantly reduce the oxidation rate of the active substance 100, such as nicotine salt, while ensuring the product appearance and release performance. Specifically, the first embedding layer 200 forms a physical protective barrier on the surface of the active substance 100. At the same time, the antioxidant as the second embedding layer 300 further increases the antioxidant properties of the active substance 100. Through the different action mechanisms of the double-layer embedding, the oxidation risk of the active substance 100 can be significantly reduced. In one embodiment, the storage stability of the product is improved by more than 30 parts. At the same time, the oral product in this application can provide an excellent user experience through the above-mentioned multi-layer structure design, while increasing personalized choices, such as increasing the type of active substances to enrich the personalized experience of the product.
[0083] Please refer to Figure 3 One embodiment of the present application provides a preparation method for preparing the oral product in any one of the above embodiments, comprising the following steps:
[0084] S10, obtaining a carrier solution including β-glucan, adding an active substance to the carrier solution, and then granulating to obtain a first embedded object 10, wherein the first embedded object 10 includes the active substance 100 and a first embedding layer 200, and the first embedding layer 200 includes β-glucan;
[0085] S20, mixing the first embedded material 10 with a filler and an antioxidant to prepare an oral product.
[0086] In step S10 of this embodiment, the active substance 100 of the oral preparation is coated, and β-glucan is used as the first embedding layer 200 to coat the active substance 100. The natural components of β-glucan form a dense network structure, which significantly isolates oxygen and moisture, thereby improving the stability of the active ingredient. In this embodiment, deionized water, glycerol and other solvents can be added for preparation. Specifically, β-glucan is fully dissolved in deionized water at a preset temperature, and glycerol is added and stirred evenly to obtain a carrier solution. The solution of active substance 100 is slowly added to the carrier solution, stirred evenly, and then spray-dried to obtain a first embedding material 10.
[0087] In one embodiment, the β-glucan is 2.5% (w / v) food-grade oat β-glucan. The preset temperature is 40°C. The amount of glycerol is controlled within a range of approximately 1% to 5% (w / v) of the carrier solids to balance product flexibility and drying process efficiency. In one embodiment, 2% (w / v) food-grade glycerol is used to obtain a 2%-3% (w / v) nicotine solution (i.e., carrier solution).
[0088] In one embodiment, the mass ratio of nicotine (active substance 100) to the solid of the carrier solution is 1:7 to 1:8. At the same time, a high-speed homogenizer (10,000 to 15,000 rpm, 3 to 5 minutes) is used for stirring to make the mixed solution uniform. The spray drying parameters are: the inlet temperature is set at about 150°C, and the outlet temperature is controlled at about 80°C. This can not only quickly dry into micro-powder capsules, but also effectively avoid nicotine degradation due to overheating. The specific stirring and spray drying process parameters are related to the actual production process and can be adaptively adjusted. This application will no longer make specific restrictions. Finally, using HPLC or GC detection, it can be measured that the nicotine loading rate reaches 10% to 15%.
[0089] In step S20 of this embodiment, the first embedding material 10 obtained in step S10 is mixed with a filler and an antioxidant to obtain the desired oral product. In this case, the antioxidant can be used as a mixture mixed with the first embedding material 10.
[0090] Please continue to refer to Figure 1 In one embodiment, step S20 further includes:
[0091] S21, obtaining an antioxidant solution containing an antioxidant, and coating the first embedded object 10 with the antioxidant solution to obtain an antioxidant embedded object 20;
[0092] S22, adding the filler and the antioxidant embedding material into a solvent and mixing them, then extruding and shaping them, drying and crushing them to obtain an oral product.
[0093] In this embodiment, step S20 is further optimized. Specifically, after step S10, the antioxidant is used to secondary embed the active substance 100 to further improve the antioxidant property of the oral preparation.
[0094] In step S21 of one embodiment, the antioxidant can be vitamin C or tea polyphenols. First, the vitamin C or tea polyphenols is dissolved in an appropriate solvent to form a uniform antioxidant solution, and then the antioxidant solution and the first embedding material are embedded. During the embedding, 5 to 10 parts of citric acid can be added to ensure its cross-linking effect. In this embodiment, the antioxidant embedding material 20 can also be heated and kept warm at a preset heating temperature and a preset heating time to form a stable cross-linked structure. In one embodiment, the heating temperature is 60°C and the heating time is 2 hours. Then, the double-layer embedding of the active substance 100 is completed.
[0095] In step S22 of this embodiment, the antioxidant embedding material 20 can be mixed with the filler. A solvent such as water can be added during mixing to homogenize the mixture and ensure uniform distribution of the ingredients. Extrusion molding and drying are then performed to complete the oral product molding process. In one embodiment, the semi-finished oral product after extrusion molding is dried to a moisture content of 10%-15%.
[0096] In step S22 of this embodiment, a crushing and screening process is performed on the semi-finished oral product to make the powder particle size of the finished oral product uniform. In one embodiment, the semi-finished oral product needs to be crushed into a powder of 20-150 mesh.
[0097] In one embodiment, the final packaging process of the oral product is performed to bag the powder of the oral product and promptly pack it into a sealed packaging box to reduce contact with air.
[0098] Below, an experimental report of this application is provided to verify the effect of this application.
[0099] 1. Experimental group and control group:
[0100] Experimental groups: Experimental groups 1 to 4; Control group: Control group 1. The content ranges shown are measured in parts by mass. The details are as follows:
[0101] Experimental Group 1:
[0102] Element use Mass fraction microcrystalline cellulose Main fillers 54.2 copies polyvinyl alcohol Fillers 12 servings Vitamin E antioxidants 1.5 servings Tea polyphenols antioxidants 1 serving silica gel powder Desiccant 2 servings Sodium bicarbonate pH adjusters 1 serving Acesulfame K sweeteners 0.3 parts Nicotine after embedding Active substances 10 servings Sodium alginate adhesives 3 servings essence Flavors and Fragrances 5 servings water solvent 10 servings
[0103] Experimental Group 2:
[0104] Element use Mass fraction microcrystalline cellulose Main fillers 54.90 servings polyvinyl alcohol Fillers 10 servings Vitamin E antioxidants 2 servings Tea polyphenols antioxidants 1 serving silica gel powder Desiccant 2 servings Sodium bicarbonate pH adjusters 2 servings Acesulfame K sweeteners 0.1 part Nicotine after embedding Active substances 8 servings Sodium alginate adhesives 2 servings essence Flavors and Fragrances 6 servings water solvent 12 servings
[0105] Experimental Group 3:
[0106] Element use Mass fraction microcrystalline cellulose Main fillers 45.8 servings polyvinyl alcohol Fillers 10 servings Vitamin E antioxidants 1 serving Tea polyphenols antioxidants 1 serving Montmorillonite Desiccant 3 servings Sodium bicarbonate pH adjusters 1 serving Acesulfame K sweeteners 0.2 servings Nicotine after embedding Active substances 15 servings Sodium alginate adhesives 3 servings essence Flavors and Fragrances 8 servings water solvent 12 servings
[0107] Experimental Group 4:
[0108] Element use Mass fraction microcrystalline cellulose Main fillers 46.8 servings polyvinyl alcohol Fillers 13 servings Vitamin E antioxidants 2 servings Tea polyphenols antioxidants 1 serving silica gel powder Desiccant 2 servings Sodium bicarbonate pH adjusters 2 servings Acesulfame K sweeteners 0.2 servings Nicotine after embedding Active substances 5 servings Sodium alginate adhesives 12 servings essence Flavors and Fragrances 5 servings water solvent 11 servings
[0109] Control group 1:
[0110] Element use Mass fraction microcrystalline cellulose Main fillers 54.2 copies polyvinyl alcohol Fillers 12 servings Vitamin E antioxidants 1.5 servings Tea polyphenols antioxidants 1 serving silica gel powder Desiccant 2 servings Sodium bicarbonate pH adjusters 1 serving Acesulfame K sweeteners 0.3 parts Unencapsulated nicotine Active substances 10 servings Sodium alginate adhesives 3 servings essence Flavors and Fragrances 5 servings water solvent 10 servings
[0111] 2. Nicotine accelerated oxidation test:
[0112] 1. Place the sealed sample product in the test box.
[0113] 2. Adjust the temperature of the test box from room temperature to 60℃±2℃ within 30 minutes and store it for 2 hours. Then cool it down to -20℃±2℃ within 30 minutes and store it for 2 hours. Return to 25℃±2℃ within 30 minutes for one cycle.
[0114] 3. A total of 16 cycles need to be performed, and the product should be taken out and placed in an environment of 25℃±2℃ for 2 hours.
[0115] 3. Sensory test indicators:
[0116] Overall odor rating (10-point scale): The freshness of the overall aroma of the oral product.
[0117] Odor intensity (5-point scale): The degree of noticeability of the odor (odor caused by oxidation). The lower the score, the better.
[0118] Aroma stability (10 points): the persistence and stability of aroma during storage.
[0119] User acceptance (10-point scale): The degree of acceptance of the aroma and overall sensory experience.
[0120] 4. Test results:
[0121]
[0122] 5. Results Analysis
[0123] 1. Overall odor score: After 90 days of storage, the overall odor score of experimental group 1 remained above 8 points, which was significantly better than that of control group 1. The overall odor scores of experimental groups 2-4 also continued to be significantly higher than that of control group 1.
[0124] 2. Odor intensity: The odor score of experimental group 1 was consistently lower than that of control group 1, and the odor scores of experimental groups 2-4 were also lower than that of control group 1, demonstrating that the experimental groups exhibited excellent antioxidant properties and effectively suppressed the odor caused by nicotine oxidation.
[0125] 3. Aroma stability: The aroma stability score of experimental group 1 was significantly higher than that of control group 1, and the aroma stability scores of experimental groups 2-4 were also significantly higher than that of control group 1, indicating that the antioxidant system of the present application has a good effect on retaining aroma during long-term storage.
[0126] 4. User acceptance: The user acceptance score of experimental group 1 was always higher than 9 points, significantly better than control group 1 (only 4 points after 90 days), and experimental groups 2-4 also continued to outperform control group 1.
[0127] In summary, the above experimental data show that the formula of the present application has a good anti-moisture absorption effect and can slow down the phenomenon of easy moisture absorption during storage.
[0128] The above description is merely an embodiment of the present application and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present application.
Claims
1. An oral product, characterized in that: The oral product comprises: a first embedding material, a filler and an antioxidant, wherein: The first embedding material includes an active substance and a first embedding layer, the first embedding layer is used to coat the active substance to isolate the active substance from the outside of the first embedding layer, and the first embedding layer includes β-glucan.
2. The oral product according to claim 1, wherein The antioxidant is coated on the outer layer of the first embedding object.
3. The oral product according to claim 1, characterized in that The antioxidant comprises at least one of vitamin C and its derivatives, rosemary extract, tea polyphenols, citric acid and vitamin E.
4. The oral product according to claim 1, wherein The oral product further comprises a hygroscopic agent, which is used to control the humidity of the oral product. The hygroscopic agent comprises at least one of silica gel powder and montmorillonite.
5. The oral product according to any one of claims 1 to 4, characterized in that The oral product further comprises at least one of a pH regulator, a sweetener, an essence and a fragrance, and an adhesive.
6. The oral product according to claim 5, characterized in that The active substance includes at least one of nicotine and a nicotine derivative; and / or, The filler comprises at least one of modified microcrystalline cellulose and polyvinyl alcohol; and / or, The pH regulator includes at least one of sodium carbonate, sodium bicarbonate, citric acid, and sodium citrate; and / or, The sweetener includes at least one of aspartame, neotame, acesulfame potassium, sucralose, and steviol glycosides; and / or, The adhesive includes at least one of sodium alginate and starch.
7. The oral product according to claim 1, characterized in that Measured by mass, the oral preparation includes 0.1 to 4 parts of active substance, 1 to 30 parts of the first embedding layer, 0.2 to 3 parts of antioxidant, 50 to 75 parts of filler, 1 to 3 parts of hygroscopic agent, 1 to 20 parts of pH regulator, 0.1 to 30 parts of sweetener, 5 to 8 parts of adhesive, and 3 to 8 parts of flavors and fragrances.
8. The oral product according to any one of claims 1 to 4, characterized in that The oral product further comprises a permeable bag that is permeable to saliva.
9. A method for preparing an oral product, characterized in that: Used to prepare the oral product according to any one of claims 1 to 8, characterized in that it comprises: Obtaining a carrier solution comprising β-glucan, adding an active substance to the carrier solution, and then granulating to obtain a first embedding material, wherein the first embedding material comprises the active substance and a first embedding layer, and the first embedding layer comprises β-glucan; The first embedding material is mixed with a filler and an antioxidant to prepare the oral product.
10. The preparation method according to claim 9, characterized in that The method of mixing the first embedding material with a filler and an antioxidant to prepare the oral product comprises: obtaining an antioxidant solution containing an antioxidant, and coating the first embedding object with the antioxidant solution to obtain an antioxidant embedding object; The filler and the antioxidant embedding material are added to a solvent and mixed, and then extruded and formed, and dried and crushed to obtain the oral product.