Nicotine hard candy and manufacturing method thereof

Abstract

The invention discloses a nicotine hard candy and a manufacturing method thereof. The nicotine hard candy comprises the following raw materials in parts by mass: 1-9 parts of a nicotine active material; 1-2 parts of a green tea extract; 1 to 2 parts of microencapsulated capsaicin; 5-15 parts of a first sweetening agent; and 60-80 parts of a carrier material. The nicotine hard candy can effectively inhibit appetite and control body weight.

Description

Technical Field

[0001] The present application relates to the technical field of buccal tablets, and in particular to a nicotine hard candy and a method for manufacturing the same. Background Art

[0002] With the improvement of public health awareness, more and more consumers are seeking effective smoking cessation products. However, although traditional nicotine replacement therapies (such as nicotine hard candies, nicotine bags, nicotine gum and patches) can meet consumers' nicotine needs, they often cannot effectively help consumers control their weight. Many consumers will experience weight gain after quitting smoking, mainly due to increased appetite and decreased metabolic rate caused by quitting smoking, which makes consumers face the trouble of weight gain during the smoking cessation process and affects the success rate of quitting smoking. Summary of the invention

[0003] The technical problem to be solved by the present application is to provide a nicotine hard candy that satisfies consumers' demand for nicotine and helps to control body weight.

[0004] The technical solution adopted by the present application to solve the technical problem is: to provide a nicotine hard candy, including raw materials and their mass fractions as follows:

[0005] 1 to 9 parts of nicotine active material;

[0006] 1-2 parts of green tea extract;

[0007] 1-2 parts of microencapsulated capsaicin;

[0008] 5 to 15 parts of the first sweetener; and

[0009] 60 to 80 parts of carrier material.

[0010] In one embodiment, the nicotine active material includes at least one of nicotine and a nicotine derivative.

[0011] In one embodiment, the carrier material comprises sorbitol.

[0012] In one embodiment, the first sweetener comprises xylitol.

[0013] In one embodiment, the raw materials of the microencapsulated capsaicin include capsaicin, capsule wall material and solvent; the capsule wall material includes at least one of gum arabic, pectin, maltodextrin and hydroxypropyl methylcellulose.

[0014] In one embodiment, the nicotine hard candy further comprises the following raw materials and their mass fractions:

[0015] 1 to 5 parts of pH adjuster.

[0016] In one embodiment, the pH adjuster includes at least one of sodium carbonate, sodium bicarbonate, citric acid, phosphoric acid, malic acid and lactic acid.

[0017] In one embodiment, the nicotine hard candy further comprises the following raw materials and their mass fractions:

[0018] 1 to 7 parts of edible flavoring.

[0019] In one embodiment, the edible flavor includes at least one of a fruit flavor, a flower flavor, and a coffee flavor.

[0020] In one embodiment, the nicotine hard candy further comprises the following raw materials and their mass fractions:

[0021] 1 to 3 parts of lubricant.

[0022] In one embodiment, the lubricant comprises magnesium stearate.

[0023] In one embodiment, the nicotine hard candy further comprises the following raw materials and their mass fractions:

[0024] 1 to 3 parts of coating material.

[0025] In one embodiment, the coating material includes at least one of gelatin, hydroxypropyl methylcellulose, chitosan and sodium alginate.

[0026] In one embodiment, the nicotine hard candy further comprises the following raw materials and their mass fractions:

[0027] 0.05-0.15 parts of the second sweetener;

[0028] The caloric content of the second sweetener is higher than the caloric content of the first sweetener.

[0029] The present application also provides a method for manufacturing nicotine hard candy, comprising: fully mixing the raw materials and then granulating them to obtain a granular process product, drying the granular process product and tableting it to obtain a sheet-like candy, so as to obtain nicotine hard candy; the raw materials include nicotine active material, green tea extract, microencapsulated capsaicin, a first sweetener and a carrier material.

[0030] In one embodiment, the method for manufacturing nicotine hard candy further comprises: spraying the coating solution onto the surface of the flake candy in the form of a spray to form a coating on the surface of the flake candy.

[0031] In one embodiment, the microencapsulated capsaicin is obtained by the following preparation method:

[0032] The capsule wall material and the solvent are mixed to form a microcapsule wall material solution, capsaicin is added into the microcapsule wall material solution, mixed and heated, and spray-dried in an atomization reaction box to form microencapsulated capsaicin.

[0033] In one embodiment, the inlet air temperature of the spray drying is controlled at 150°C to 180°C, and the outlet air temperature is controlled at 70°C to 90°C.

[0034] Beneficial effects of the present application: Nicotine hard candy formed by nicotine active material, microencapsulated capsaicin, green tea extract and other auxiliary agents can meet the user's need for nicotine and have an appetite suppressant effect, solve the problem that nicotine substitutes on the current market lack weight control or weight loss functions, and help users effectively suppress appetite and control weight during the process of quitting smoking, thereby reducing the weight gain problem that may be caused by quitting smoking. Microencapsulated capsaicin can effectively control the release rate of capsaicin in the oral cavity, avoid excessive stimulation of the user's oral cavity, and make the action time of capsaicin longer, and more continuously exert the effect of increasing energy consumption and suppressing appetite. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The present application will be further described below with reference to the accompanying drawings and embodiments, in which:

[0036] Figure 1 is a comparison chart of the release curves of nicotine hard candies in the examples of the present application;

[0037] Figure 2 This is a comparison chart of the peak release time of nicotine hard candies in the examples of the present application. DETAILED DESCRIPTION

[0038] The nicotine hard candy of the present application includes the following raw materials and their mass fractions:

[0039] 1 to 9 parts of nicotine active material;

[0040] 1-2 parts of green tea extract;

[0041] 1-2 parts of microencapsulated capsaicin;

[0042] 5 to 15 parts of the first sweetener; and

[0043] 60 to 80 parts of carrier material.

[0044] Among them, nicotine active materials are used to replace nicotine in tobacco or e-liquid, and can dissolve in the user's body (for example, dissolved in saliva in the mouth) to release nicotine, simulating the satisfaction brought by nicotine when smoking, and helping users reduce their dependence on tobacco and other products during the process of quitting smoking. At the same time, nicotine also has a certain effect of suppressing appetite, which helps users control their weight.

[0045] The nicotine active material includes at least one of nicotine and nicotine derivatives. Among them, nicotine further includes natural nicotine and synthetic nicotine; nicotine derivatives include but are not limited to nicotine salts, nicotine substitutes, and salts of nicotine substitutes. Nicotine salts further include but are not limited to nicotine tartrate (nicotine tartaric acid dihydrate salt), nicotine benzoate, nicotine lactate, etc. Nicotine substitutes refer to nicotine containing substituents, such as 6-methyl nicotine. The salt of nicotine substitutes refers to the product of nicotine containing substituents combined with acid, such as 6-methyl nicotine benzoate.

[0046] Green tea extract contains catechins and caffeine, which can increase metabolism and suppress appetite, and can slow down the oxidation of nicotine. Green tea extract is also a natural antioxidant, which can further slow down or inhibit the oxidation of nicotine.

[0047] The first sweetener is used to provide sweetness, preferably xylitol, which has the advantage of low calories.

[0048] The carrier material is the main base material of nicotine hard candy, and sorbitol is preferably used, which not only fills and stabilizes the formula, but also effectively absorbs nicotine. The small particle size of sorbitol brings about a large bottom surface area, which can slow down the release rate of nicotine, increase the time for users to feel nicotine, and improve user experience.

[0049] Microencapsulated capsaicin in nicotine hard candy helps increase energy consumption, increases the appetite suppressant effect of nicotine hard candy, and can supplement the lack of nicotine stimulation. Microencapsulated capsaicin is formed by microencapsulation of capsaicin.

[0050] Microencapsulation (microencapsulation) can effectively protect capsaicin from external environmental factors (such as light, heat, oxygen, etc.), prevent its oxidation and degradation, and extend the shelf life of the product. The wall material of the microcapsule can be selected in different materials and thicknesses as needed to achieve the slow release of capsaicin in the mouth, which helps to reduce the burning sensation caused by capsaicin directly stimulating the mouth, while making the action time of capsaicin longer and more continuously exert the effect of increasing energy consumption and suppressing appetite. In the mouth, the microencapsulation treatment will not release a strong spicy taste immediately, but will be gradually released with chewing and the rupture of the microcapsules, making it easier for users to accept the taste of the product.

[0051] When preparing microencapsulated capsaicin, a capsule wall material and a solvent are mixed to form a microencapsule wall material solution, capsaicin is added to the microencapsule wall material solution, mixed and heated, and spray-dried in an atomization reaction box to form microencapsulated capsaicin. The capsule wall material includes at least one of gum arabic, pectin, maltodextrin and hydroxypropyl methylcellulose; the solvent is selected according to the capsule wall material. Suitable solvents, such as water, etc.

[0052] In one embodiment of preparing microencapsulated capsaicin, gum arabic, maltodextrin and water are mixed to form a microcapsule wall material solution, capsaicin is added to the microcapsule wall material solution and mixed evenly, then heated to 60°C, and spray-dried in an atomization reaction box to form microencapsulated capsaicin. The inlet air temperature of the spray drying can be controlled at 150°C-180°C, and the outlet air temperature is 70°C-90°C.

[0053] In some embodiments, the nicotine hard candy also includes a second sweetener, which provides additional sweetness compared to the first sweetener, further increases the sweetness of the nicotine hard candy, and meets the needs of different users. The mass fraction of the second sweetener can be 0.05 to 0.15 parts. For low-calorie xylitol as the first sweetener, the calories of the second sweetener are higher than the calories of the first sweetener. Specifically, sweeteners in the prior art can be selected, including but not limited to one or more of acesulfame potassium, sucralose, neotame, stevia, licorice, disodium glycyrrhizinate, tripotassium glycyrrhizinate and trisodium glycyrrhizinate.

[0054] In some embodiments, the nicotine hard candy further includes a pH adjuster for adjusting the pH of the nicotine hard candy, and the weight fraction thereof is 1 to 5. Further, the pH adjuster may include at least one of sodium carbonate, sodium bicarbonate, citric acid, phosphoric acid, malic acid and lactic acid.

[0055] Nicotine hard candy can also include 1 to 7 portions of edible flavors to provide corresponding aroma and taste for the nicotine hard candy and improve the user experience. Edible flavors use various existing flavors that can be added to food, including but not limited to at least one of fruit flavors, flower flavors, and coffee flavors; fruit flavors include strawberry flavors, various berry flavors, mixed berry flavors, mango flavors, lemon flavors, watermelon flavors, grape flavors, peach flavors, pear flavors, banana flavors, citrus flavors, and apple flavors, etc. Flower flavors include flower flavors and herbal flavors, further including but not limited to mint flavors, vanilla flavors, licorice flavors, lavender flavors, and jasmine, rose, camellia, gardenia, and other flower flavors.

[0056] In some embodiments, the flavor is combined with a corresponding pH adjuster according to the pH requirement of its volatilization, and the options include: strawberry flavor combined with sodium carbonate, mixed berry flavor combined with sodium bicarbonate, citrus flavor combined with citric acid, coffee flavor combined with phosphoric acid, apple flavor combined with malic acid, and mint flavor combined with lactic acid.

[0057] In one embodiment, the nicotine hard candy further comprises 1 to 3 parts of a lubricant to ensure the uniformity and stability of the nicotine hard candy. The lubricant includes but is not limited to magnesium stearate.

[0058] According to the requirement that the nicotine hard candy is in the form of a lozenge, the nicotine hard candy also includes 1 to 3 parts of coating material. The coating material forms the outermost structure of the nicotine hard candy, and coats the main body formed by mixing other raw materials inside, which helps to closely combine the raw materials and further prolong the sustained release effect, so that nicotine and weight control can play a role more continuously and efficiently.

[0059] The coating material includes at least one of gelatin, hydroxypropyl methylcellulose, chitosan and sodium alginate.

[0060] The manufacturing method of nicotine hard candy of the present application comprises: fully mixing the raw materials and then granulating them to obtain a granular process product, drying the granular process product and tableting it to obtain a sheet-like candy, so as to obtain nicotine hard candy.

[0061] The manufacturing method of the nicotine hard candy of the present application may further include coating the nicotine hard candy, that is, preparing a coating material to form a coating solution, spraying the coating solution onto the surface of the flake candy (i.e., nicotine hard candy) in a spray form, and forming a coating on the surface of the flake candy.

[0062] Taking nicotine-tartrate as an example, the specific operation of making nicotine hard candy is as follows:

[0063] Step 1: Mixing and granulation.

[0064] Add nicotine-tartrate, sorbitol, xylitol, microencapsulated capsaicin and pH regulator into a high-efficiency wet mixing granulator and mix them through the high-efficiency wet mixing granulator; in the high-efficiency wet mixing granulator, the stirring paddle is at a low speed, and the corresponding frequency is 2Hz; the cutting paddle is at a low speed, and the corresponding frequency is 25Hz; mix for 5 minutes. After mixing, granulate through the high-efficiency wet mixing granulator, the material temperature after mixing is 50°C, the stirring paddle of the high-efficiency wet mixing granulator is at a high speed, and the corresponding frequency is 5Hz; the cutting paddle of the high-efficiency wet mixing granulator is at a high speed, and the corresponding frequency is 30Hz; run for 1 minute.

[0065] Step 2: Drying.

[0066] After granulation, the pellets were dried in a forced air drying oven. Drying temperature: 45°C ± 5°C, drying time: 40 minutes, moisture content LOD ≤ 5.0%.

[0067] In order to obtain granules with better uniformity, the granulated and dried granules are subjected to rotary granulation by a rotary granulator to remove granules that do not meet the specifications.

[0068] Step 3: Total mixing.

[0069] According to the need to add additional sweetness or fragrance, the whole granules are placed in a three-dimensional mixer, and the required sweeteners, edible flavors and magnesium stearate are added and mixed. The mixing time can be but not limited to 10 minutes, and the frequency corresponding to the mixing speed can be but not limited to 30 Hz.

[0070] Step 4: tableting.

[0071] The above-obtained granules are placed in a rotary tablet press for tableting. The tablet weight to be pressed is determined according to the granule content, and the tablet weight difference limit is ±5.0%. Calculation method: tablet weight to be pressed (g) = 0.65 × 100% ÷ content.

[0072] The turntable speed is 30 rpm, the filling depth is 10 mm, and the pressure is 50 kN.

[0073] Step 5: Coating.

[0074] Slowly sprinkle the coating material powder into water preheated to about 60°C to avoid the formation of lumps. Continue stirring until the coating material powder is completely dissolved, which usually takes 20 minutes to 30 minutes, and the concentration of the formed coating solution ranges from 1% to 5%. The stirring speed is moderate to ensure uniform mixing, for example, it can be 300rpm-500rpm. At 40°C, spray the coating solution onto the surface of the flaky nicotine hard candy obtained by tableting, and form a coating layer on the surface of the nicotine hard candy after solidification. Wherein, the spray rate is 1ml / min, and the coating time is 30 minutes.

[0075] The present application is further described below with reference to specific embodiments.

[0076] 1. The raw materials and contents of nicotine hard candy are shown in Table 1.

[0077] Table 1. Raw materials and content of nicotine hard candy

[0078] raw material Content range Nicotine-tartrate 2.84％ Green Tea Extract 1-2％ Microencapsulated capsaicin 1-2％ Sorbitol 63.3～77.3％ Xylitol 5-15％ pH Adjusters 4.76％ Sweeteners 0.05～0.15％ Food flavors 1～7％ Magnesium Stearate 1～3％ gelatin 1～3％

[0079] The above raw materials were used to prepare nicotine hard candies (9 mg / piece) in the form of a sheet having a coating layer.

[0080] It can be understood that the above raw materials and their contents are only a representative embodiment of the present application, and the same applies within the raw material content range of the present application.

[0081] 2. Verification

[0082] (1) Verification of the weight loss effect of nicotine hard candy

[0083] Objective: To evaluate the effectiveness of nicotine hard candy for weight management and appetite suppression.

[0084] Subjects: 20 healthy adult smokers, aged 22-45 years, with a body mass index (BMI) in the overweight range (between 25 and 30).

[0085] The subjects were randomly divided into two groups: an experimental group (who took nicotine hard candy one hour before each dinner) and a control group (who took nicotine-free placebo hard candy one hour before each dinner).

[0086] The trial lasted for 8 weeks, during which food intake from daily buffet dinners was recorded and weight changes were tracked.

[0087] The changes in food intake and body weight of the experimental group and the control group are shown in Table 2 and Table 3, respectively.

[0088] Table 2. Changes in food intake in the experimental and control groups

[0089]

[0090] Table 3. Body weight changes in the experimental and control groups

[0091]

[0092] Verification results:

[0093] From the analysis of food intake, the food intake of the experimental group decreased significantly, from 719 in week 0 to 589 in week 8, indicating that nicotine hard candy significantly suppressed appetite. The food intake of the control group only decreased slightly.

[0094] From the analysis of weight changes, at the end of the 8th week, the average weight of the experimental group was 80.0kg, a total weight loss of 5.0kg compared to 85.0kg at the beginning of the trial. The weight change of the control group was relatively small, only decreasing by 0.5kg.

[0095] It can be understood that the raw materials and their contents shown in Table 1 are only a representative embodiment of the present application, and other embodiments within the raw material content range of the present application can also achieve the effects of suppressing appetite, etc. of the aforementioned representative embodiments.

[0096] (2) Verify the sustained release effect of nicotine hard candy - dissolution curve test

[0097] Equipment: Dissolution apparatus - paddle method.

[0098] Samples: 1g nicotine hard candy, three sets of parallel samples. 1g uncoated nicotine hard candy, one set of control samples.

[0099] Dissolution medium: artificial saliva - pH 6.8.

[0100] Sampling points: 1min, 3min, 5min, 10min, 20min, 30min, 45min, 60min.

[0101] Test conditions: heating temperature 37°C, speed 100r / min.

[0102] Analysis method: High performance liquid chromatography was used to detect nicotine content.

[0103] The results are shown in Table 4.

[0104] Table 4. Nicotine release of nicotine hard candy parallel samples and control samples over time

[0105]

[0106]

[0107] Fitting release dynamic function: y = 100a(1-e -bt ).

[0108] The time when 80% of the total nicotine release is taken as the peak time.

[0109] The release curves of nicotine hard candy parallel samples 1, 2, 3 and the control sample are as follows Figure 1 As shown, Figure 1 In the figure, curves 1, 2, and 3 are release curves of nicotine hard candy parallel samples 1, 2, and 3, respectively, and curve 4 is the release curve of the control sample. The peak times of nicotine hard candy parallel samples 1, 2, and 3 and the control sample are shown in FIG. Figure 2 shown.

[0110] From the comparison of release curves, it can be seen that the curves of parallel samples 1, 1 and 3 are relatively gentle, gradually approaching the maximum release within 14 minutes, reflecting the characteristics of the slow-release formula. This release characteristic is suitable for nicotine release that requires a longer duration, helping users maintain a more stable nicotine absorption level, and helping to improve the appetite suppression effect. The curve of the control sample rises rapidly, approaching the maximum release of nicotine within 8 minutes, and the duration is shorter than that of parallel samples 1 to 3, indicating that the coating helps the sustained release of the active ingredients of nicotine hard candy.

[0111] from Figure 2 The peak time graph of the nicotine hard candy control sample is shorter than the peak time of the nicotine hard candy parallel samples 1 to 3, which is 8 minutes, indicating that its release speed is fast. In the present application, the peak time of the nicotine hard candy parallel samples 1 to 3 is longer, and the longest time is close to 14 minutes, indicating that its release speed is slow, meeting the slow release requirements.

[0112] In summary, the nicotine hard candy of the present application can effectively suppress appetite and reduce weight, meeting the needs of users at different levels. At the same time, its sustained-release effect helps to maintain a more stable nicotine absorption level and improve user experience.

[0113] The above descriptions are merely embodiments of the present application and are not intended to 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. A nicotine hard candy, characterized in that: The raw materials and their mass fractions are as follows:

2. The nicotine hard candy according to claim 1, characterized in that The nicotine active material comprises at least one of nicotine and a nicotine derivative; and / or, The carrier material comprises sorbitol; and / or, The first sweetener includes xylitol.

3. The nicotine hard candy according to claim 1, characterized in that The raw materials of the microencapsulated capsaicin include capsaicin, capsule wall material and solvent; the capsule wall material includes at least one of gum arabic, pectin, maltodextrin and hydroxypropyl methylcellulose.

4. The nicotine hard candy according to claim 1, characterized in that The nicotine hard candy also includes raw materials and their mass fractions are as follows:

5. The nicotine hard candy according to claim 4, characterized in that The pH adjuster includes at least one of sodium carbonate, sodium bicarbonate, citric acid, phosphoric acid, malic acid and lactic acid; and / or, The edible flavor includes at least one of a fruit flavor, a flower flavor and a coffee flavor; and / or, The lubricant comprises magnesium stearate; and / or, The coating material comprises at least one of gelatin, hydroxypropyl methylcellulose, chitosan and sodium alginate.

6. The nicotine hard candy according to any one of claims 1 to 5, characterized in that: The nicotine hard candy also includes raw materials and their mass fractions are as follows: 0.05-0.15 parts of the second sweetener; The caloric content of the second sweetener is higher than the caloric content of the first sweetener.

7. A method for preparing nicotine hard candy, for preparing the nicotine hard candy according to any one of claims 1 to 6, characterized in that: include: The raw materials are fully mixed and then granulated to obtain a granular process product, and the granular process product is dried and tableted to obtain a flake candy to obtain nicotine hard candy; The raw materials include nicotine active material, green tea extract, microencapsulated capsaicin, a first sweetener and a carrier material.

8. The method for producing nicotine hard candy according to claim 7, characterized in that: After the tableting is performed to obtain the flake sugar, the method further comprises: spraying a coating solution onto the surface of the flake sugar in a spraying form to form a coating layer on the surface of the flake sugar.

9. The method for producing nicotine hard candy according to claim 7 or 8, characterized in that: The microencapsulated capsaicin is obtained by the following preparation method: The capsule wall material and the solvent are mixed to form a microcapsule wall material solution, capsaicin is added into the microcapsule wall material solution, mixed and heated, and spray-dried in an atomization reaction box to form microencapsulated capsaicin.

10. The method for producing nicotine hard candy according to claim 9, characterized in that: The inlet air temperature of spray drying is controlled at 150℃~180℃, and the outlet air temperature is controlled at 70℃~90℃.

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