Nicotine composition, preparation method thereof and buccal product

Abstract

The invention belongs to the technical field of nicotine compositions, and relates to a nicotine composition, a preparation method thereof and a buccal product. The nicotine composition comprises the following materials: nicotine, poloxamer, and at least one of a polybasic sugar alcohol and a metal complex. In the application, poloxamer can form a micellar structure to fully wrap nicotine, so that the finally formed nicotine composition can be better absorbed by oral mucosa; the nicotine composition can be kept in a stable form by the aid of the polyhydric sugar alcohol; the metal complex can reduce the catalytic oxidation effect of metal ions on nicotine, so that the product is not easy to oxidize and discolor, and the stability of the nicotine composition is further improved. In conclusion, the nicotine composition is long in storage time and appropriate in release time.

Description

Technical Field

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

[0003] Nicotine in oral products usually exists in the form of tobacco extracts, free nicotine, liquid nicotine salts, etc. The above forms of nicotine are less stable, resulting in a too fast release rate after being taken. When users take oral products, the taste is stronger in the early stage, and the strength is significantly weakened in the later stage, and then the smoke quickly fades, resulting in a poor user experience; at the same time, because the nicotine in oral products is released too quickly, the free nicotine enters the stomach and intestines along with saliva, which will irritate the mouth and gastrointestinal tract, causing discomfort in the body; then, as time goes by, nicotine in the form of tobacco extracts, various nicotine salts, etc. will continue to be released, causing the product to oxidize and turn yellow and darken in color. At the same time, the nicotine smell is obvious, which seriously affects the aroma and taste of oral products, and thus has a greater negative impact on the quality of the product.

[0004] In summary, the existing nicotine compositions have a nicotine release rate that is too fast and a short storage time that is poor. Summary of the invention

[0005] The technical problem to be solved by the embodiments of the present application is that the existing nicotine compositions have an excessively fast nicotine release rate and a short storage time.

[0006] In order to solve the above technical problems, the present application provides a nicotine composition, which adopts the following technical solution:

[0007] A nicotine composition, the material of the nicotine composition comprising:

[0008] Nicotine and poloxamer, and at least one of polyols and metal complexes.

[0009] Further, the polyol includes one or more of glycerol, mannitol, erythritol, sorbitol, maltitol, lactitol, and xylitol; and / or,

[0010] The metal complex comprises one or more of disodium ethylenediaminetetraacetate, pentasodium diethylenetriaminepentaacetate, trisodium nitrilotriacetate, and tetrasodium ethylene glycol bis(2-aminoethyl ether)tetraacetate; and / or,

[0011] The poloxamer includes one or more of poloxamer 407, poloxamer 188, poloxamer 184 and poloxamer 124.

[0012] Furthermore, the nicotine composition further comprises reducing sugar; and / or,

[0013] The nicotine composition also includes an organic acid.

[0014] Further, the organic acid includes one or more of formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, oxalic acid, citric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, benzoic acid, pyruvic acid, levulinic acid, tartaric acid, lactic acid, malonic acid, succinic acid, fumaric acid, gluconic acid, saccharic acid, salicylic acid, sorbic acid, malonic acid or malic acid; and / or,

[0015] The reducing sugar includes one or more of glucose, fructose, galactose, lactose and maltose; and / or,

[0016] In the nicotine composition, the content of nicotine is 10% to 20%, the content of reducing sugar is 3% to 6%, the content of polyol is 1% to 3%, the content of metal complex is 0.1% to 0.5%, the content of organic acid is 0.2% to 0.8%, and the content of poloxamer is 69.7% to 85.7%.

[0017] Accordingly, the present application also provides a method for preparing a nicotine composition, the method comprising the steps of:

[0018] Provides nicotine, poloxamer and first substance;

[0019] Performing a first stirring process on nicotine, poloxamer and the first substance to form a first mixture;

[0020] Performing a heating process and a second stirring process on the first mixture until nicotine and poloxamer are melted, thereby obtaining a second mixture;

[0021] Cooling and solidifying the second mixture to obtain a nicotine composition;

[0022] Wherein, the first substance includes at least one of polyols and metal complexes.

[0023] Further, the temperature of the first stirring treatment is 20° C. to 30° C.; and / or,

[0024] The temperature of the heating treatment is 70°C to 85°C; and / or,

[0025] The temperature of the cooling and curing treatment is 20°C to 30°C; and / or,

[0026] The stirring speed of the first stirring treatment is 600 r / min to 800 r / min; and / or,

[0027] The first stirring treatment time is 5 min to 30 min; and / or,

[0028] The stirring speed of the second stirring treatment is 600 r / min to 800 r / min; and / or,

[0029] The second stirring treatment time is 4 h to 6 h.

[0030] Furthermore, the first substance also includes an organic acid; and / or,

[0031] The first substance further comprises reducing sugar; and / or,

[0032] The step of cooling and solidifying the second mixture is specifically:

[0033] Cooling and solidifying the second mixture to obtain a third mixture;

[0034] The third mixture is crushed to obtain the nicotine composition.

[0035] Further, the organic acid includes one or more of formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, oxalic acid, citric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, benzoic acid, pyruvic acid, levulinic acid, tartaric acid, lactic acid, malonic acid, succinic acid, fumaric acid, gluconic acid, saccharic acid, salicylic acid, sorbic acid, malonic acid or malic acid; and / or,

[0036] The reducing sugar includes one or more of glucose, fructose, galactose, lactose and maltose; and / or,

[0037] In the first mixture, the content of nicotine is 10% to 20%, the content of reducing sugar is 3% to 6%, the content of polyol is 1% to 3%, the content of metal complex is 0.1% to 0.5%, the content of organic acid is 0.2% to 0.8%, and the content of poloxamer is 69.7% to 85.7%.

[0038] Accordingly, the present application also provides an oral product, the material of which includes a nicotine composition, and the nicotine composition is the nicotine composition described in any one of the above embodiments, or the nicotine composition is prepared by the preparation method of the nicotine composition described in any one of the above embodiments.

[0039] Furthermore, the material of the oral product also includes one or more of microcrystalline cellulose, propylene glycol, water, food flavor, sodium chloride, sodium carbonate, acesulfame potassium, aspartame and vitamin E; or,

[0040] The materials of the oral product also include microcrystalline cellulose, propylene glycol, water, food flavor, sodium chloride, sodium carbonate, acesulfame potassium, aspartame and vitamin E;

[0041] Among them, the content of the nicotine composition is 6% to 10%, the content of the microcrystalline cellulose is 55% to 65%, the content of the propylene glycol is 3% to 5%, the content of the water is 10% to 20%, the content of the food flavor is 5% to 10%, the content of the sodium chloride is 1% to 3%, the content of the sodium carbonate is 1% to 2%, the content of the acesulfame potassium is 2% to 4%, the content of aspartame is 1% to 2%, and the content of the vitamin E is 1% to 2%.

[0042] Compared with the prior art, the embodiments of the present application have the following beneficial effects:

[0043] In the present application, poloxamer can form a micellar structure, thereby fully encapsulating nicotine, so that the final nicotine composition can be better absorbed by the oral mucosa; polyols can enable the nicotine composition to maintain a stable form; metal complexes can reduce the catalytic oxidation of nicotine by metal ions, making the product less prone to oxidation and discoloration, thereby improving the stability of the nicotine composition. In summary, the nicotine composition has a long storage time and a suitable release time. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In order to more clearly illustrate the scheme of the present application, a brief introduction is given below to the drawings required for use in the description of the embodiments. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0045] Figure 1 is a flow chart of a method for preparing a nicotine composition according to an embodiment of the present application;

[0046] Figure 2 is a schematic diagram of a nicotine composition prepared in Example 1 of the nicotine composition of the present application;

[0047] Figure 3 is a schematic diagram of a nicotine composition prepared in Nicotine Composition Example 9 of the present application;

[0048] Figure 4 is a schematic diagram of a nicotine composition prepared in Comparative Example 1 of the nicotine composition of the present application;

[0049] Figure 5 is a schematic diagram of a nicotine composition prepared in Comparative Example 2 of the nicotine composition of the present application;

[0050] Figure 6 is a schematic diagram of a nicotine composition prepared in Comparative Example 4 of the nicotine composition of the present application;

[0051] Figure 7 is a schematic diagram of a nicotine composition prepared in Comparative Example 6 of the nicotine composition of the present application;

[0052] Figure 8 is a schematic diagram of a nicotine composition prepared in Comparative Example 8 of the nicotine composition of the present application;

[0053] Fig. 9 is a schematic diagram of a nicotine composition prepared in Comparative Example 10 of the nicotine composition of the present application;

[0054] Fig.10 is a schematic diagram of an oral product prepared in Example 1 of the oral product of the present application;

[0055] Fig.11 This is a schematic diagram of the oral product prepared in Example 1 of the oral product of the present application after being left for a period of time;

[0056] Fig.12 It is a schematic diagram of the oral product prepared in comparative example 1 of the oral product of the present application;

[0057] Fig.13 This is a schematic diagram of the oral product prepared in comparative example 1 of the oral product of the present application after being left for a period of time. DETAILED DESCRIPTION

[0058] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by technicians in the technical field of this application; the terms used in the specification of the application herein are only for the purpose of describing specific embodiments and are not intended to limit this application; the terms "including" and "having" and any variations thereof in the specification and claims of this application and the above-mentioned drawings are intended to cover non-exclusive inclusions. The terms "first", "second", etc. in the specification and claims of this application or the above-mentioned drawings are used to distinguish different objects, not to describe a specific order.

[0059] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0060] In order to solve the above problems, the present application provides a nicotine composition, and the materials of the nicotine composition include:

[0061] Nicotine and poloxamer, and at least one of polyols and metal complexes.

[0062] In this embodiment, firstly, poloxamer can form a micellar structure, thereby fully encapsulating nicotine to form a water-soluble oil-in-water gel, and the water solubility of nicotine is increased through the surface activity, thereby enabling the final nicotine composition to be better absorbed by the oral mucosa; secondly, the polyol has good moisturizing, anti-crystallization and chemical stability, and can enable the nicotine composition to maintain a stable form, thereby improving the stability of the nicotine composition; and then, the metal complex can reduce the catalytic oxidation effect of metal ions on nicotine, making the product less prone to oxidation and discoloration, thereby improving the stability of the nicotine composition.

[0063] In summary, when the nicotine composition includes nicotine and poloxamer, and at least one of a polyol and a metal complex, the release rate of nicotine can be effectively reduced while increasing the storage time of the nicotine composition.

[0064] Further, the polyol includes one or more of glycerol, mannitol, erythritol, sorbitol, maltitol, lactitol, and xylitol; and / or,

[0065] The metal complex comprises one or more of disodium ethylenediaminetetraacetate, pentasodium diethylenetriaminepentaacetate, trisodium nitrilotriacetate, and tetrasodium ethylene glycol bis(2-aminoethyl ether)tetraacetate; and / or,

[0066] The poloxamer includes one or more of poloxamer 407, poloxamer 188, poloxamer 184, and poloxamer 124.

[0067] In this embodiment, these polyols have the functions of moisturizing, anti-crystallization, physical support and enhanced chemical stability, which help maintain the morphological stability, suitable taste and stable chemical properties of the nicotine composition. Metal complexes are effective metal ion chelators that can chelate metal ions in the system to prevent metal ions from catalyzing oxidation or decomposition reactions of other components, thereby improving the chemical stability of the composition. Poloxamer materials can form micellar structures to encapsulate nicotine, increase the water solubility of nicotine, have emulsification and dispersion capabilities, adjust rheological properties or act as solubilizers, which are beneficial to the stable presence of nicotine, uniform dispersion, control the release rate and enhance the overall stability of the composition.

[0068] Furthermore, the nicotine composition further comprises reducing sugar; and / or,

[0069] The nicotine composition also includes an organic acid.

[0070] In this embodiment, reducing sugar can play an antioxidant role, preventing nicotine from being oxidized by heating during the preparation of the nicotine composition, thereby improving the stability and yield of the nicotine composition. Organic acid can maintain the acidity of the system during the preparation of the nicotine composition, so that the nicotine composition contains a small amount of nicotine salt, thereby improving the chemical stability of the nicotine composition.

[0071] Further, the organic acid includes one or more of formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, oxalic acid, citric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, benzoic acid, pyruvic acid, levulinic acid, tartaric acid, lactic acid, malonic acid, succinic acid, fumaric acid, gluconic acid, saccharic acid, salicylic acid, sorbic acid, malonic acid or malic acid; and / or,

[0072] The reducing sugar includes one or more of glucose, fructose, galactose, lactose and maltose; and / or,

[0073] In the nicotine composition, the content of nicotine is 10% to 20%, the content of reducing sugar is 3% to 6%, the content of polyol is 1% to 3%, the content of metal complex is 0.1% to 0.5%, the content of organic acid is 0.2% to 0.8%, and the content of poloxamer is 69.7% to 85.7%.

[0074] In this embodiment, the selected organic acid can effectively maintain the acidic environment during the preparation of the nicotine composition, thereby improving the chemical stability of the nicotine composition. The selection of reducing sugar can have a higher antioxidant property, prevent nicotine oxidation caused by heating, and help improve the stability and yield of the composition. In the nicotine composition, the content of nicotine and poloxamer can make the nicotine composition have a suitable taste, and can be completely wrapped by poloxamer to reduce the nicotine release rate. The content of polyols, organic acids, reducing sugars, and metal complexes can make the nicotine composition have a higher stability, so as to increase the storage time of the nicotine composition and reduce the release rate.

[0075] Accordingly, please refer to Figure 1 The present application also provides a method for preparing a nicotine composition, the method comprising the steps of:

[0076] S100, providing nicotine, poloxamer, and first substance;

[0077] S200, performing a first stirring process on nicotine, poloxamer and the first substance to form a first mixture;

[0078] S300, performing a heating process and a second stirring process on the first mixture until the nicotine and the poloxamer are melted to obtain a second mixture;

[0079] S400, cooling and solidifying the second mixture to obtain a nicotine composition;

[0080] Wherein, the first substance includes at least one of polyols and metal complexes.

[0081] In this embodiment, poloxamer can form a micellar structure, thereby fully encapsulating nicotine to form a water-soluble gel of oil-in-water type, and the water solubility of nicotine is increased through the surface activity, so that the final nicotine composition can be better absorbed by the oral mucosa; secondly, the polyol in the first substance has good moisture retention, anti-crystallization, and chemical stability, which can enable the nicotine composition to maintain a stable form to improve the stability of the nicotine composition; then, the metal complex can reduce the catalytic oxidation of nicotine by metal ions, so that the product is not easy to oxidize and discolor, thereby improving the stability of the nicotine composition. In summary, the nicotine composition prepared by the preparation method of this embodiment includes nicotine and poloxamer, and at least one of the polyol and the metal complex, which can effectively reduce the release rate of nicotine and increase the storage time of the nicotine composition.

[0082] It should be understood that, compared with the solution of preserving nicotine in the form of microcapsules in the prior art, the solution of this embodiment has a simple preparation process, so the production cost is low and the production efficiency is high; at the same time, during the preparation of the nicotine composition of this embodiment, no solvent such as edible ethanol is added, so there is no solvent residue on the surface of the nicotine composition, and the taste is better.

[0083] Further, the temperature of the first stirring treatment is 20°C to 30°C; and / or,

[0084] The temperature of the heating treatment is 70°C to 85°C; and / or,

[0085] The temperature of the cooling and curing treatment is 20°C to 30°C; and / or,

[0086] The stirring speed of the first stirring treatment is 600 r / min to 800 r / min; and / or,

[0087] The first stirring treatment time is 5min to 30min; and / or,

[0088] The stirring speed of the second stirring treatment is 600 r / min to 800 r / min; and / or,

[0089] The second stirring treatment time is 4h to 6h.

[0090] In this embodiment, the temperature, stirring speed and stirring time of the first stirring treatment can make the materials in the first mixture mix evenly, thereby improving the yield of the nicotine composition; the temperature of the heating treatment can melt nicotine and poloxamer so that the poloxamer can wrap nicotine. The time and speed of the second stirring treatment can make the poloxamer in the second mixture fully wrap nicotine, thereby improving the stability of the nicotine composition.

[0091] Furthermore, the first substance also includes an organic acid; and / or,

[0092] The first substance further comprises a reducing sugar; and / or,

[0093] The steps of cooling and solidifying the second mixture are specifically as follows:

[0094] Cooling and solidifying the second mixture to obtain a third mixture;

[0095] The third mixture is pulverized to obtain a nicotine composition.

[0096] Further, the organic acid includes one or more of formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, oxalic acid, citric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, benzoic acid, pyruvic acid, levulinic acid, tartaric acid, lactic acid, malonic acid, succinic acid, fumaric acid, gluconic acid, saccharic acid, salicylic acid, sorbic acid, malonic acid or malic acid; and / or,

[0097] The reducing sugar includes one or more of glucose, fructose, galactose, lactose and maltose; and / or,

[0098] In the first mixture, the nicotine content is 10% to 20%, the reducing sugar content is 3% to 6%, the polyol content is 1% to 3%, the metal complex content is 0.1% to 0.5%, the organic acid content is 0.2% to 0.8%, and the poloxamer content is 69.7% to 85.7%.

[0099] In this embodiment, reducing sugar can play an antioxidant role, preventing nicotine from being oxidized by heating during the preparation of the nicotine composition, thereby improving the stability and yield of the nicotine composition. Organic acid can maintain the acidity of the system during the preparation of the nicotine composition, so that the nicotine composition contains a small amount of nicotine salt, thereby improving the chemical stability of the nicotine composition.

[0100] Accordingly, the present application also provides an oral product, the material of the oral product includes a nicotine composition, the nicotine composition is the nicotine composition of any one of the above embodiments, or the nicotine composition is prepared by the preparation method of the nicotine composition of any one of the above embodiments.

[0101] In this embodiment, since the material of the oral product includes the above-mentioned nicotine composition, the oral product has a strong antioxidant capacity, and before being taken into the mouth, the nicotine smell of the oral product is wrapped and hidden by poloxamer, so it will not affect the aroma of the oral product, thereby improving the taste of the oral product.

[0102] Furthermore, the materials of the oral product also include one or more of microcrystalline cellulose, propylene glycol, water, food flavor, sodium chloride, sodium carbonate, acesulfame potassium, aspartame and vitamin E; or,

[0103] The materials of oral products also include microcrystalline cellulose, propylene glycol, water, food flavors, sodium chloride, sodium carbonate, acesulfame potassium, aspartame and vitamin E;

[0104] Among them, the content of nicotine composition is 6% to 10%, the content of microcrystalline cellulose is 55% to 65%, the content of propylene glycol is 3% to 5%, the content of water is 10% to 20%, the content of food flavor is 5% to 10%, the content of sodium chloride is 1% to 3%, the content of sodium carbonate is 1% to 2%, the content of acesulfame potassium is 2% to 4%, the content of aspartame is 1% to 2%, and the content of vitamin E is 1% to 2%.

[0105] In this embodiment, the materials of the oral product and the content range thereof can make the oral product have suitable nicotine, flavor and taste, thereby improving the quality of the oral product.

[0106] To facilitate understanding of the nicotine composition of the above examples of the present application, the betel nut chewing gum in the examples of the present application is specifically described below through experimental comparison.

[0107] Embodiment 1:

[0108] This embodiment provides a method for preparing a nicotine composition, which comprises the following steps:

[0109] Step 1, providing raw materials: providing raw materials required for the nicotine composition, wherein nicotine 20g, poloxamer (P407) 72.4g, glucose 5g, mannitol 2g, EDTA-disodium 0.2g, oxalic acid 0.4g;

[0110] Step 2, first stirring treatment: nicotine, poloxamer (P407), glucose, mannitol, EDTA-disodium and oxalic acid are placed in a glass container, and a first stirring treatment is performed at room temperature of 25° C. until the mixture is uniform, the stirring time of the first stirring treatment is 10 min, and the stirring speed is 700 r / min, to obtain a first mixture;

[0111] Step 3, second stirring treatment: raising the temperature of the glass container to 75° C., and performing a second stirring treatment on the first mixture, wherein the stirring time of the second stirring treatment is 5 hours, and the stirring speed is 700 r / min, until the nicotine and poloxamer are melted, to obtain a second mixture;

[0112] Step 4: Granulation: Cool the glass container to room temperature (25°C) to solidify the second mixture, and crush the second mixture to obtain Figure 2 Nicotine composition shown (white powder).

[0113] Embodiment 2:

[0114] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 20 g, poloxamer (P407) 71.4 g, glucose 4.6 g, mannitol 2.9 g, EDTA-disodium 0.5 g, and oxalic acid 0.8 g are added.

[0115] Embodiment 3:

[0116] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 10 g, poloxamer (P407) 85.5 g, glucose 3 g, mannitol 1 g, EDTA-disodium 0.2 g, and oxalic acid 0.3 g are added.

[0117] Embodiment 4:

[0118] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 10 g, poloxamer (P407) 83.4 g, glucose 4.3 g, mannitol 1.6 g, EDTA-disodium 0.3 g, and oxalic acid 0.4 g are added.

[0119] Embodiment 5:

[0120] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 15 g, poloxamer (P407) 78.2 g, glucose 4.5 g, mannitol 1.7 g, EDTA-disodium 0.2 g, and oxalic acid 0.4 g are added.

[0121] Embodiment 6:

[0122] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 15 g, poloxamer (P407) 79.1 g, glucose 3.4 g, mannitol 1.8 g, EDTA-disodium 0.3 g, and oxalic acid 0.4 g are added.

[0123] Embodiment 7:

[0124] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 18 g, poloxamer (P407) 74.4 g, glucose 4.6 g, mannitol 2.2 g, EDTA-disodium 0.3 g, and oxalic acid 0.5 g are added.

[0125] Embodiment 8:

[0126] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 18 g, poloxamer (P407) 73.3 g, glucose 5.1 g, mannitol 2.6 g, EDTA-disodium 0.4 g, and oxalic acid 0.6 g are added.

[0127] Embodiment 9:

[0128] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 20g, poloxamer (P188) 73.2g, glucose 4g, mannitol 2.1g, EDTA-disodium 0.2g, oxalic acid 0.5g are added. In step 4, the following is obtained: Figure 3 White powder shown.

[0129] Embodiment 10:

[0130] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 20 g, poloxamer (P407) 71.4 g, glucose 5.5 g, xylitol 2.2 g, EDTA-disodium 0.3 g, and oxalic acid 0.6 g are added.

[0131] Embodiment 11:

[0132] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 20 g, poloxamer (P407) 72.55 g, glucose 5 g, mannitol 1.9 g, NTA trisodium 0.2 g, and oxalic acid 0.35 g are added.

[0133] Embodiment 12:

[0134] The preparation method is basically the same as that in Example 1, except that: in step 1, nicotine 20 g, poloxamer (P407) 72.55 g, glucose 4.5 g, mannitol 2.2 g, NTA trisodium 0.2 g, and citric acid 0.25 g are added.

[0135] Embodiment 13:

[0136] The preparation method is basically the same as that of Example 1, except that: in step 1, nicotine 20 g, poloxamer (P407) 72.55 g, fructose 4.5 g, mannitol 2.2 g, NTA trisodium 0.2 g, and citric acid 0.25 g are added.

[0137] Comparative Example 1:

[0138] The preparation method is basically the same as that in Example 1, except that in step 1, only 20 g of nicotine and 80 g of poloxamer (P407) are contained to obtain Figure 3 In step 4, the nicotine composition is obtained as shown in Figure 4 The brown-yellow powder shown, at this point, the nicotine is oxidized.

[0139] Comparative Example 2:

[0140] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 20g, poloxamer (P407) 72.55g, glucose 5g, mannitol 2g, EDTA-disodium 0.05g, oxalic acid 0.4g. In step 4, obtain Figure 5 The yellow powder shown, at this point, the nicotine is oxidized.

[0141] Comparative Example 3:

[0142] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 20g, poloxamer (P407) 72.6g, glucose 5g, mannitol 2g, oxalic acid 0.4g. In step 4, similar Figure 5 The yellow powder shown, at this point, the nicotine is oxidized.

[0143] Comparative Example 4:

[0144] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 20g, poloxamer (P407) 75.9g, glucose 1.5g, mannitol 2g, EDTA-disodium 0.2g, oxalic acid 0.4g. In step 4, obtain Figure 6 The light yellow powder shown, at this point, the nicotine is oxidized.

[0145] Comparative Example 5:

[0146] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 20g, poloxamer (P407) 77.4g, mannitol 2g, EDTA-disodium 0.2g, oxalic acid 0.4g. In step 4, a similar Figure 6 The light yellow powder shown, at this point, the nicotine is oxidized.

[0147] Comparative Example 6:

[0148] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 20g, poloxamer (P407) 73.9g, glucose 5g, mannitol 0.5g, EDTA-disodium 0.2g, oxalic acid 0.4g. In step 4, obtain Figure 7The yellow powder shown, at this point, the nicotine is oxidized.

[0149] Comparative Example 7:

[0150] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 20g, poloxamer (P407) 74.4g, glucose 5g, EDTA-disodium 0.2g, oxalic acid 0.4g. In step 4, similarly Figure 7 The yellow powder shown, at this point, the nicotine is oxidized.

[0151] Comparative Example 8:

[0152] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 20g, poloxamer (P407) 72.75g, glucose 5g, mannitol 2g, EDTA-disodium 0.2g, oxalic acid 0.05g. In step 4, obtain Figure 8 Yellow powder as shown.

[0153] Comparative Example 9:

[0154] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 20g, poloxamer (P407) 72.8g, glucose 5g, mannitol 2g, EDTA-disodium 0.2g. In step 4, similar Figure 8 The yellow powder shown, at this point, the nicotine is oxidized.

[0155] Comparative Example 10:

[0156] The preparation method is basically the same as that in Example 1, except that: in step 1: 30 g nicotine, 62.4 g poloxamer (P407), 5 g glucose, 2 g mannitol, 0.2 g EDTA-disodium, 0.4 g oxalic acid. In step 4, a similar Fig. 9 The yellow viscous semi-solid shown, at this time, the nicotine is oxidized and the nicotine is not completely encapsulated.

[0157] Comparative Example 11:

[0158] The preparation method is basically the same as that of Example 1, except that: in step 1: nicotine 5g, poloxamer (P407) 77.4g, glucose 5g, mannitol 2g, EDTA-disodium 0.2g, oxalic acid 0.4g. In step 4, a similar Figure 2 White powder shown.

[0159] Oral product example 1

[0160] This embodiment provides a method for preparing an oral product, which comprises the following steps:

[0161] Step 1, providing raw materials. Provide raw materials for oral products: 10g nicotine composition (product prepared in Example 1), 59.6g microcrystalline cellulose, 4.3g propylene glycol, 12g water, 6g green tea flavor, 1.5g sodium chloride, 1.8g sodium carbonate, 2.6g acesulfame potassium, 1.1g aspartame, and 1.1g vitamin E.

[0162] Step 2: Prepare oral products. Fully mix the above raw materials, sterilize with UV for 3 hours, seal and refrigerate for 24 hours, mix and sieve the materials, take the powder with a particle size of 20 mesh, mix evenly, and pack into 0.5g per bag of oral cigarettes as the finished product. Fig.10 Each bag contains 10mg of nicotine. Fig.11 , the color basically did not change.

[0163] Oral preparation comparative example 1

[0164] This comparative example provides a method for preparing an oral product, which comprises the following steps:

[0165] Step 1, provide raw materials. Provide raw materials for oral products: 5.7g nicotine-tartaric acid dihydrate (nicotine content 35%), 63.9g microcrystalline cellulose, 4.3g propylene glycol, 12g water, 6g green tea flavor, 1.5g sodium chloride, 1.8g sodium carbonate, 2.6g acesulfame potassium, 1.1g aspartame, and 1.1g vitamin E.

[0166] Step 2: prepare oral products. Mix thoroughly and sterilize with UV for 3 hours, seal and refrigerate for 24 hours, mix and sieve the materials, take the powder with a particle size of 20 mesh, mix evenly, and pack into 0.5g per bag of oral cigarettes as the finished product. Fig.12 Each bag contains 10mg of nicotine. After 30 days of storage, Fig.13 , the color turns yellow.

[0167] The pictures of the nicotine compositions obtained in Examples 2 to 8 are similar Figure 2 It is shown as white powder. According to the above Examples 1 to 8 and Comparative Example 1, in the nicotine composition provided by the present application, reducing sugar, organic acid, polyol and metal complex can fully improve the stability of the nicotine composition, thereby increasing its storage time and reducing its nicotine release rate.

[0168] According to Example 1, Examples 9 to 13, Figure 2 and Figure 3 It can be seen that the types of materials such as poloxamer, reducing sugar, organic acid, metal complex and polyol provided in the present application can make the prepared nicotine composition have high stability.

[0169] According to Example 1 and Comparative Examples 2 to 9, Figure 2 , Figures 4 to 8 It can be seen that any one of organic acids, reducing sugars, polyols and metal complexes can improve the stability of the nicotine composition, prevent it from being oxidized, and thus increase its storage time.

[0170] According to Example 1 and Comparative Examples 10 to 11, Figure 2 and Fig. 9 It can be seen that when the nicotine content is too high, poloxamer cannot completely encapsulate nicotine, which makes it easy to be oxidized and releases faster. When the nicotine content is reduced, it does not meet the preparation requirements of oral products and has a poor taste.

[0171] According to oral preparation example 1 and oral preparation comparative example 1, and Figure 10 to Figure 13 It can be seen that the oral product prepared from the nicotine composition prepared in this embodiment has a longer storage time and a better appearance.

[0172] Obviously, the embodiments described above are only some embodiments of the present application, rather than all embodiments. The preferred embodiments of the present application are given in the accompanying drawings, but they do not limit the patent scope of the present application. The present application can be implemented in many different forms. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present application more thorough and comprehensive. Although the present application is described in detail with reference to the aforementioned embodiments, for those skilled in the art, it is still possible to modify the technical solutions recorded in the aforementioned specific implementation methods, or to perform equivalent replacement of some of the technical features therein. Any equivalent structure made using the contents of the specification and drawings of this application, directly or indirectly used in other related technical fields, is similarly within the scope of patent protection of this application.

Claims

1. A nicotine composition, characterized in that: The materials of the nicotine composition include: Nicotine and poloxamer, and at least one of polyols and metal complexes.

2. The nicotine composition according to claim 1, characterized in that The polyols include one or more of glycerol, mannitol, erythritol, sorbitol, maltitol, lactitol, and xylitol; and / or, The metal complex comprises one or more of disodium ethylenediaminetetraacetate, pentasodium diethylenetriaminepentaacetate, trisodium nitrilotriacetate, and tetrasodium ethylene glycol bis(2-aminoethyl ether)tetraacetate; and / or, The poloxamer includes one or more of poloxamer 407, poloxamer 188, poloxamer 184 and poloxamer 124.

3. The nicotine composition according to claim 2, characterized in that The nicotine composition further comprises a reducing sugar; and / or, The nicotine composition also includes an organic acid.

4. The nicotine composition according to claim 3, characterized in that The organic acid comprises one or more of formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, oxalic acid, citric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, benzoic acid, pyruvic acid, levulinic acid, tartaric acid, lactic acid, malonic acid, succinic acid, fumaric acid, gluconic acid, saccharic acid, salicylic acid, sorbic acid, malonic acid or malic acid; and / or, The reducing sugar includes one or more of glucose, fructose, galactose, lactose and maltose; and / or, In the nicotine composition, the content of nicotine is 10% to 20%, the content of reducing sugar is 3% to 6%, the content of polyol is 1% to 3%, the content of metal complex is 0.1% to 0.5%, the content of organic acid is 0.2% to 0.8%, and the content of poloxamer is 69.7% to 85.7%.

5. A method for preparing a nicotine composition, characterized in that: The steps of the method include: Provides nicotine, poloxamer and first substance; performing a first stirring process on the nicotine, the poloxamer and the first substance to form a first mixture; performing a heating process and a second stirring process on the first mixture until the nicotine and the poloxamer are melted to obtain a second mixture; Cooling and solidifying the second mixture to obtain the nicotine composition; Wherein, the first substance includes at least one of polyols and metal complexes.

6. The method for preparing the nicotine composition according to claim 5, characterized in that: The temperature of the first stirring treatment is 20°C to 30°C; and / or, The temperature of the heating treatment is 70°C to 85°C; and / or, The temperature of the cooling and curing treatment is 20°C to 30°C; and / or, The stirring speed of the first stirring treatment is 600 r / min to 800 r / min; and / or, The first stirring treatment time is 5 min to 30 min; and / or, The stirring speed of the second stirring treatment is 600 r / min to 800 r / min; and / or, The second stirring treatment time is 4 h to 6 h.

7. The method for preparing the nicotine composition according to claim 5, characterized in that: The first substance further comprises an organic acid; and / or, The first substance further comprises reducing sugar; and / or, The step of cooling and solidifying the second mixture is specifically: Cooling and solidifying the second mixture to obtain a third mixture; The third mixture is crushed to obtain the nicotine composition.

8. The method for preparing the nicotine composition according to claim 7, characterized in that: The organic acid comprises one or more of formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, oxalic acid, citric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, benzoic acid, pyruvic acid, levulinic acid, tartaric acid, lactic acid, malonic acid, succinic acid, fumaric acid, gluconic acid, saccharic acid, salicylic acid, sorbic acid, malonic acid or malic acid; and / or, The reducing sugar includes one or more of glucose, fructose, galactose, lactose and maltose; and / or, In the first mixture, the content of nicotine is 10% to 20%, the content of reducing sugar is 3% to 6%, the content of polyol is 1% to 3%, the content of metal complex is 0.1% to 0.5%, the content of organic acid is 0.2% to 0.8%, and the content of poloxamer is 69.7% to 85.7%.

9. An oral product, characterized in that: The material of the oral product includes a nicotine composition, and the nicotine composition is the nicotine composition according to any one of claims 1 to 4, or the nicotine composition is prepared by the preparation method of the nicotine composition according to any one of claims 5 to 8.

10. The oral product according to claim 9, characterized in that The material of the oral product further includes one or more of microcrystalline cellulose, propylene glycol, water, food flavor, sodium chloride, sodium carbonate, acesulfame potassium, aspartame and vitamin E; or, The materials of the oral product also include microcrystalline cellulose, propylene glycol, water, food flavor, sodium chloride, sodium carbonate, acesulfame potassium, aspartame and vitamin E; Among them, the content of the nicotine composition is 6% to 10%, the content of the microcrystalline cellulose is 55% to 65%, the content of the propylene glycol is 3% to 5%, the content of the water is 10% to 20%, the content of the food flavor is 5% to 10%, the content of the sodium chloride is 1% to 3%, the content of the sodium carbonate is 1% to 2%, the content of the acesulfame potassium is 2% to 4%, the content of aspartame is 1% to 2%, and the content of the vitamin E is 1% to 2%.

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