CN-121987599-A - Nicotine oral dissolving film and preparation method thereof

CN121987599ACN 121987599 ACN121987599 ACN 121987599ACN-121987599-A

Abstract

The patent discloses a nicotine oral solution and a preparation method thereof, wherein the nicotine oral solution comprises the steps of A, stirring and mixing a nicotine source, an electrolyte solution and an additive to obtain a nicotine oral solution, B, carrying out water bath treatment on the nicotine oral solution to obtain a pretreatment solution, carrying out electrochemical treatment on the pretreatment solution to enable the electrolyte to be ionized so as to be defoamed, thus obtaining the defoamed nicotine oral solution, and C, carrying out post treatment on the defoamed nicotine oral solution to obtain the nicotine oral solution. The electrochemical parameter method is used for defoaming treatment, so that the introduction of impurities is reduced, the defoaming time is shortened, the transparency of the solution is improved to be more than 88%, the size of bubbles is reduced to be 5-10 mu m, the number of bubbles is reduced to 8/mL, and the solution still has higher stability after being stored for about 1 month under different temperature conditions. The prepared nicotine oral-dissolving film product has high transparency, uniform nicotine release and obviously enhanced consumption experience.

Inventors

HONG JUNJIE
LI RUOXI
ZHANG YIMING
LIU LEI
Xiong zhe
XIAO QIAN
SHI QIUXIANG
Li Guchun

Assignees

湖北中烟工业有限责任公司

Dates

Publication Date: 20260508
Application Date: 20260304

Claims (10)

1. A method for preparing a nicotine oral-dissolving film, which is characterized by comprising the following steps: step A, stirring and mixing a nicotine source, an electrolyte solution and an additive to obtain a nicotine oral solution; Step B, carrying out water bath treatment on the nicotine oral solution to obtain a pretreatment solution, and carrying out electrochemical treatment on the pretreatment solution to ionize and defoam electrolyte so as to obtain a defoamed nicotine oral solution; and C, carrying out post-treatment on the defoamed nicotine oral solution to obtain the nicotine oral solution.
2. The method for preparing a nicotine oral film according to claim 1, wherein in the step B, The defoaming treatment conditions are that the current is set to be 40 mA-50 mA, the voltage is set to be 0.7-1.0V, 1.0-1.2V, 1.2-1.4V or 1.4-1.7V, and the defoaming treatment is kept for 10-15 min.
3. The method for preparing a nicotine oral solution according to claim 2, wherein the transparency of the defoamed nicotine oral solution is improved by 88% or more, the size of bubbles in the defoamed nicotine oral solution is 5-10 μm, and the number of bubbles in the defoamed nicotine oral solution is less than or equal to 8/mL.
4. The method for preparing a nicotine oral film according to claim 1, wherein in the step a, the addition amount of the nicotine source is 0.3-1.0%, the addition amount of the additive is 33-48%, and the addition amount of the electrolyte solution is 0.1-0.3 mol/L based on 100% of the mass percentage of the nicotine oral film solution; The pH value of the nicotine oral solution is 7.0+/-0.2.
5. The method of preparing a nicotine oral film of claim 4, wherein the additive comprises a film-forming material and a plasticizer; The addition amount of the film forming material is 30-40%, and the film forming material comprises one or a combination of more of hypromellose, polyvinyl alcohol, polyoxyethylene or polyvinylpyrrolidone; the addition amount of the plasticizer is 1.0-2.5%, and the plasticizer comprises one or more of glycerol, polyethylene glycol, tween 80 or propylene glycol.
6. The method for preparing a nicotine oral film according to claim 5, wherein the additive further comprises 0.03-0.10% by mass of sweetener, 0.05-0.10% by mass of pH regulator and 0.5-1.0% by mass of flavoring essence and spice.
7. The method for preparing a nicotine oral film according to claim 1, wherein the rotation speed of stirring and mixing is 300-800 rpm/min, and the stirring and mixing time is 10-30 min.
8. The method for preparing an orosol film according to claim 1, wherein in the step C, the post-treatment is specifically: Coating the defoamed nicotine oral solution on a coating plane with a release film by using a coating machine, wherein the coating speed is 4-8 mm/s, the temperature of the coating plane is 40-45 ℃, and cutting the film after drying at 50-60 ℃ to obtain the nicotine oral solution; the size of the nicotine oral dissolving film is (10-15) mm; the nicotine oral film is capable of long term storage for at least 28 days.
9. A nicotine oral film, characterized in that the nicotine oral film is prepared by the preparation method of the nicotine oral film according to any one of the above claims 1-8; The nicotine oral-dissolving film comprises free electrolyte ions, wherein the free electrolyte ions are generated by an electrolyte solution under the electrolytic condition, and the electrolyte solution comprises one or a combination of a plurality of potassium chloride solution, potassium bromide solution, sodium chloride solution or potassium nitrate solution.
10. The nicotine oral solution of claim 9, wherein the cumulative dissolution rate of nicotine in the nicotine oral solution at 0 th to 5 th minutes is 50% or more, and the cumulative dissolution rate of nicotine in the nicotine oral solution at 0 th to 10 th minutes is 95% or more.

Description

Nicotine oral dissolving film and preparation method thereof Technical Field The patent belongs to the technical field of nicotine buccal products, and in particular relates to a nicotine oral solution film and a preparation method thereof. Background The nicotine oral dissolving film is used as a novel nicotine delivery system, is generally made of a soluble material, contains a certain amount of nicotine active substances, can be directly applied to different parts such as sublingual parts, gingiva and the like, is absorbed by mucous membrane and can quickly enter blood, and the nicotine oral dissolving film has the advantages of quick effect, convenience in use and the like and is widely focused. The preparation method of the nicotine oral-dissolving film generally comprises the steps of preparing film-forming liquid, coating to form film, drying, cutting and packaging. In the existing film forming liquid preparation process, bubbles in the solution can influence the uniformity and stability of the film, so that the product quality is influenced. The traditional film forming liquid defoaming method mainly comprises stirring, standing, ultrasonic treatment or vacuumizing. The method has the advantages that the stirring, standing or ultrasonic defoaming is low in efficiency, impurities are easy to introduce, the transparency of the film forming liquid is extremely easy to reduce, the appearance of a product is influenced, the stability of the product is reduced, impurities are not introduced in vacuumizing, the efficiency of removing bubbles with smaller diameters, for example, diameters smaller than 50 mu m, is low, the bubbles are slowly and easily recaptured by the film forming liquid due to the rising speed of the bubbles, and the solvent of the vacuumizing defoaming solution volatilizes, so that the viscosity of the vacuumized film forming liquid is increased, and uneven thickness or rough surface can be caused in casting film forming. These problems affect not only the quality of the nicotine orosol film product, but also the user experience. Therefore, there is a need for a defoaming method capable of rapidly removing bubbles in an orosolution without introducing other impurities, improving the transparency of the orosolution, and having good stability, so that the prepared nicotine orosolution product has high transparency, uniform nicotine release and stable quality after long-term storage. Disclosure of Invention The purpose of this patent is to provide a nicotine mouth-soluble film and preparation method thereof, realize not introducing under the circumstances of other impurity, get rid of the bubble in the mouth-soluble film solution fast, improve mouth-soluble film solution's transparency to have good stability's purpose, so that the nicotine mouth-soluble film product's that the preparation obtained transparency is high, and the nicotine release is even, and the product's after long-term storage quality is stable. The technical problem is not solved, and the patent provides the following technical scheme: a method for preparing a nicotine oral dissolving film, comprising the following steps: step A, stirring and mixing a nicotine source, an electrolyte solution and an additive to obtain a nicotine oral solution; Step B, carrying out water bath treatment on the nicotine oral solution to obtain a pretreatment solution, and carrying out electrochemical treatment on the pretreatment solution to ionize and defoam electrolyte so as to obtain the defoamed nicotine oral solution; and C, carrying out post-treatment on the defoamed nicotine oral solution to obtain the nicotine oral solution. Further, in the step B, the conditions of the defoaming treatment are specifically that the current is set to be 40 mA-50 mA, the voltage is set to be 0.7-1.0V, 1.0-1.2V, 1.2-1.4V or 1.4-1.7V, and the defoaming treatment is kept for 10-15 min. Further, the transparency of the defoamed nicotine oral solution is improved by 88% or more, the size of bubbles in the defoamed nicotine oral solution is 5-10 mu m, and the number of bubbles in the defoamed nicotine oral solution is less than or equal to 8/mL. In the step A, the mass percentage of the nicotine oral solution is 100%, the addition amount of the nicotine source is 0.3-1.0%, the addition amount of the additive is 33-48%, and the addition amount of the electrolyte solution is 0.1-0.3 mol/L. Further, the pH value of the nicotine oral solution is 7.0+ -0.2. Further, the additives include a film-forming material and a plasticizer. Further, the addition amount of the film forming material is 30-40%, and the film forming material comprises one or more of hydroxypropyl methylcellulose, polyvinyl alcohol, polyoxyethylene or polyvinylpyrrolidone. Further, the addition amount of the plasticizer is 1.0-2.5%, and the plasticizer comprises one or more of glycerol, polyethylene glycol, tween 80 or propylene glycol. Further, the additive further comprises 0.03-0.10% of sweeten