CN-121986956-A - Buccal tablet and preparation method thereof

CN121986956ACN 121986956 ACN121986956 ACN 121986956ACN-121986956-A

Abstract

The application belongs to the technical field of oral products, and particularly relates to a buccal tablet and a preparation method thereof. The buccal tablet comprises a first supporting layer, a functional layer and a second supporting layer which are sequentially stacked, wherein at least one of the first supporting layer and the second supporting layer is a liquid permeable layer, the functional layer comprises corn silk, and the functional layer further comprises an active ingredient and/or a flavoring agent. Because the corn silk is of a porous network structure, compared with the existing buccal product, the corn silk can better lock saliva, and further the problem that the corn silk enters the stomach to generate discomfort is solved.

Inventors

HE HAIBO
HU ZHENG
PAN ZHAOHUA
Miao Xiushi
ZHANG BIN
YAN XINYANG
Request for anonymity
CHEN LIANGXIN

Assignees

爱奇迹创造有限公司

Dates

Publication Date: 20260508
Application Date: 20260206

Claims (10)

1. The buccal tablet is characterized by comprising a first supporting layer, a functional layer and a second supporting layer which are sequentially laminated; at least one of the first supporting layer and the second supporting layer is a liquid permeable layer, the functional layer comprises corn silk, and the functional layer further comprises an active ingredient and/or a flavoring agent.
2. The lozenge of claim 1, wherein the functional layers comprise at least two sub-functional layers, and at least one of the sub-functional layers comprises corn silk.
3. The buccal tablet according to claim 2, wherein an isolation layer is arranged between two adjacent sub-functional layers; and/or the thickness of the sub-functional layer is 25-300 mu m; And/or, the first supporting layer and the second supporting layer are both liquid permeable layers.
4. A buccal tablet according to any one of claims 1 to 3, wherein the particle size of the corn silk is d90≤50 μm; And/or the mass ratio of the corn silk in the functional layer is 1% -25%; and/or, the moisture content of the buccal tablet is less than or equal to 10%.
5. A buccal tablet according to any one of claims 1 to 3, wherein the functional layer further comprises at least one of a film forming matrix, a softener, a pH adjuster and an antioxidant.
6. A buccal tablet according to claim 5, wherein the active ingredient comprises nicotine and/or a nicotine derivative; And/or, the flavoring agent comprises at least one of essence, sweetener, cooling agent, sour agent and salty agent; and/or the film forming matrix comprises at least one of hypromellose, sodium alginate, gelatin, acacia, pregelatinized starch, pullulan and hyprolose; And/or the softener comprises at least one of glycerol and polyethylene glycol; and/or the pH regulator comprises at least one of sodium bicarbonate, sodium carbonate, sodium citrate and malic acid; And/or the antioxidant comprises at least one of vitamin E, ascorbyl palmitate, tertiary butyl p-hydroxy anisole and di-tertiary butyl p-cresol.
7. The buccal tablet according to claim 1, wherein the functional layer comprises, in parts by mass, 1 to 25 parts of the corn silk, 0.5 to 20 parts of the active ingredient, 0.3 to 13 parts of the flavoring agent, 0.1 to 5 parts of the softener, 0.1 to 2 parts of the pH regulator, 3 to 38 parts of the film forming matrix, and 0.01 to 5 parts of the antioxidant.
8. A method for preparing a buccal tablet according to any one of claims 1 to 7, comprising: Obtaining a film forming liquid, wherein the film forming liquid comprises corn silk, and the film forming liquid further comprises an active ingredient and/or a flavoring agent; coating and forming the film forming liquid into a functional layer; and respectively covering the first supporting layer and the second supporting layer on two sides of the functional layer which are oppositely arranged to obtain the buccal tablet, wherein at least one of the first supporting layer and the second supporting layer is a liquid permeable layer.
9. The method according to claim 8, wherein the obtaining the film-forming liquid comprises: Dissolving a film-forming matrix in water, and obtaining a first mixed solution through first stirring; adding active ingredients, softening agents, flavoring agents and antioxidants into the first mixed solution, and obtaining a second mixed solution through second stirring; adding corn silk into the second mixed solution, and obtaining a third mixed solution through third stirring; and adding a pH regulator into the third mixed solution, and obtaining the film forming solution through fourth stirring, wherein the pH value of the film forming solution is 4-9.
10. The method according to claim 8, wherein the functional layer includes a first sub-functional layer and a second sub-functional layer, and an isolation layer is further disposed between the first sub-functional layer and the second sub-functional layer, and the step of coating the film forming solution to form the functional layer includes: Respectively obtaining a first film forming liquid and a second film forming liquid, wherein at least one of the first film forming liquid and the second film forming liquid comprises corn silk; And coating the first film forming liquid and the second film forming liquid on the first surface and the second surface which are oppositely arranged on the isolation layer respectively to form a first sub-functional layer and a second functional layer.

Description

Buccal tablet and preparation method thereof Technical Field The application belongs to the technical field of oral products, and particularly relates to a buccal tablet and a preparation method thereof. Background There are various types of buccal tablets, among which, the orosol film is a novel film structure, does not need chewing, and can be rapidly dissolved in saliva of the oral cavity. However, the orosol film or the double-layered orosol film is easy to swallow to the stomach after dissolving in saliva, resulting in stomach discomfort. In order to solve the problem, the prior art adopts a form of externally-added non-woven fabric to lock the colloid solution after dissolving the oral dissolving film, but the colloid solution is too much beyond the water absorption capacity of the non-woven fabric, so that part of colloid solution enters the stomach to generate discomfort. Disclosure of Invention The application aims to provide a buccal tablet and a preparation method thereof, which are used for solving the problem that saliva after dissolving an orolytic membrane is difficult to lock, so that the saliva enters the stomach to cause discomfort. In order to solve the technical problems, the application provides a buccal tablet, which comprises a first supporting layer, a functional layer and a second supporting layer which are sequentially stacked, wherein at least one of the first supporting layer and the second supporting layer is a liquid permeable layer, the functional layer comprises corn silk, and the functional layer further comprises an active ingredient and/or a flavoring agent. In one embodiment, the functional layer comprises at least two sub-functional layers, and at least one of the sub-functional layers comprises corn silk. In one embodiment, an isolation layer is arranged between two adjacent sub-functional layers, and/or the thickness of the sub-functional layers is 25-300 μm, and/or the first supporting layer and the second supporting layer are liquid permeable layers. In one embodiment, the corn silk has a particle size D90 of 50 μm or less, and/or the corn silk accounts for 1% -25% of the functional layer by mass, and/or the buccal tablet has a water content of 10% or less. In one embodiment, the functional layer further comprises at least one of a film forming matrix, a softening agent, a pH adjuster, and an antioxidant. In one embodiment, the active ingredient comprises nicotine and/or nicotine derivatives, and/or the flavoring agent comprises at least one of essence, sweetener, cooling agent, acidulant and salty agent, and/or the film forming matrix comprises at least one of hypromellose, sodium alginate, gelatin, acacia, pregelatinized starch, pullulan, and hydroxypropyl cellulose, and/or the softening agent comprises at least one of glycerol and polyethylene glycol, and/or the pH regulator comprises at least one of sodium bicarbonate, sodium carbonate, sodium citrate, and malic acid, and/or the antioxidant comprises at least one of vitamin E, ascorbyl palmitate, tert-butyl p-hydroxyanisole, and di-tert-butyl p-cresol. In one embodiment, the functional layer comprises, by mass, 1-25 parts of corn silk, 0.5-20 parts of the active ingredient, 0.3-13 parts of the flavoring agent, 0.1-5 parts of the softener, 0.1-2 parts of the pH regulator, 3-38 parts of the film forming matrix and 0.01-5 parts of the antioxidant. The application also provides a preparation method of the buccal tablet, which comprises the steps of obtaining a film forming liquid, wherein the film forming liquid comprises corn silk, the film forming liquid further comprises active ingredients and/or flavoring agents, coating and forming the film forming liquid into a functional layer, and respectively covering a first supporting layer and a second supporting layer on two opposite sides of the functional layer to obtain the buccal tablet, wherein at least one of the first supporting layer and the second supporting layer is a liquid permeable layer. In one embodiment, the film forming liquid is obtained by dissolving a film forming matrix in water, obtaining a first mixed liquid through first stirring, adding an active ingredient, a softening agent, a flavoring agent and an antioxidant into the first mixed liquid, obtaining a second mixed liquid through second stirring, adding corn silk into the second mixed liquid, obtaining a third mixed liquid through third stirring, adding a pH regulator into the third mixed liquid, and obtaining the film forming liquid through fourth stirring, wherein the pH value of the film forming liquid is 4-9. In one embodiment, the functional layer comprises a first sub-functional layer and a second sub-functional layer, an isolation layer is further arranged between the first sub-functional layer and the second sub-functional layer, the film forming liquid is coated and formed into the functional layer, the method comprises the steps of respectively obtaining a first film forming liquid and