阅读说明：本技术 一种按压式双储药层的微针贴片 (Push type microneedle patch with double drug storage layers ) 是由 蒋乐伦 龚霞 黄冠豪 曹宇奇 于 2021-09-02 设计创作，主要内容包括：本发明涉及医疗设备技术领域,公开了一种按压式双储药层的微针贴片,包括粘贴层,安装在粘贴层上的微针阵列模块和固定连接在微针阵列模块上的载药层模块；还公开了一种对所述微针阵列药贴制备方法,包括对所述微针阵列药贴的组合步骤。本发明集涂布、穿刺和传输三个过程为一体,解决了现有技术领域亟需一种既可以解决统的透皮治疗脱发方式给药效率较低,又可以不造成疼痛,不造成伤疤的治疗设备的问题。(The invention relates to the technical field of medical equipment, and discloses a push type microneedle patch with double drug storage layers, which comprises an adhesive layer, a microneedle array module arranged on the adhesive layer and a drug-loaded layer module fixedly connected to the microneedle array module; also discloses a preparation method of the micro-needle array patch, which comprises the step of combining the micro-needle array patch. The invention integrates three processes of coating, puncturing and transmission, and solves the problem that the prior art needs a treatment device which can solve the problems of low administration efficiency, no pain and no scar caused by a traditional alopecia transdermal treatment mode.)

1. The utility model provides a micropin paster on two medicine storage layers of push type which characterized in that: comprises an adhesive layer (5), a microneedle array module (1) arranged on the adhesive layer (5) and a drug-loaded layer module (2) fixedly connected on the microneedle array module.

2. The microneedle patch with the pressing type double drug storage layers as claimed in claim 1, wherein: the adhesive layer (5) comprises an inner surface and an outer surface, wherein the inner surface of the adhesive layer (5) is an adhesive surface, and the outer surface is a non-adhesive surface; the microneedle array module (1) is smaller in size than the adhesive layer (5) and the microneedle array module (1) is mounted on the inner surface of the adhesive layer (5).

3. The microneedle patch with the pressing type double drug storage layers as claimed in claim 1, wherein: the microneedle array module (1) comprises a substrate (3) and a microneedle array (4); the microneedle array (4) is used for fixedly connecting the bottom of the microneedle array (4) with the upper surface of the substrate (3) in a direction vertical to the substrate (3) to form a microneedle array module.

4. The microneedle patch with the pressing type double drug storage layers as claimed in claim 1, wherein: the drug-loaded layer module (2) comprises a first drug-loaded layer (6), a second drug-loaded layer (7) and a diaphragm (8); the lower bottom surface of the second drug-loaded layer (7) is fixedly connected with the upper surface of the diaphragm (8), and the lower surface of the diaphragm (8) is fixedly connected with the upper surface of the first drug-loaded layer (6); the first drug-loaded layer (6) is fixedly connected with the substrate (8) through the lower surface of the first drug-loaded layer.

5. The microneedle patch with the pressing type double drug storage layers as claimed in claim 4, wherein: the first drug-loaded layer (6) comprises a first drug storage layer (9) and a first anti-seepage gasket (10); the first anti-seepage gasket (10) is fixedly connected to the upper surface of the substrate (3) and is fixedly connected with the first medicine storage layer (9) by surrounding the first medicine storage layer (9); the lower surface of the first medicine storage layer (9) is fixedly connected with the substrate (3); the micro-needle array (4) is fixedly connected with the first medicine storage layer (9) by inserting the first medicine storage layer (9).

6. The microneedle patch with the pressing type double drug storage layers as claimed in claim 4, wherein: the second drug-loaded layer (7) comprises a second drug storage layer (11) and a second anti-seepage gasket (12);

the lower bottom surface of the second anti-seepage gasket (12) is fixedly connected with the upper surface of the diaphragm (8), and the second anti-seepage gasket (12) is fixedly connected with the second medicine storage layer (11) by surrounding the second medicine storage layer (11).

7. The microneedle patch with the pressing type double drug storage layers as claimed in claim 5, wherein: the first anti-seepage gasket (10) is soft and is arranged into a hollow structure; and the first impermeable gasket (10) has a height exceeding the height of the microneedle array (4).

8. The microneedle patch with the pressing type double drug storage layers as claimed in claim 6, wherein: the second impermeable gasket (12) is rigid and is arranged into a hollow structure; the second impermeable gasket (12) is lower than the microneedle array (4).

9. The microneedle patch with the push type double drug storage layers as claimed in any one of claims 5 or 6, wherein: the first medicine storage layer (9) and the second medicine storage layer (11) are both porous soft bodies; the first medicine storage layer (9) stores a first medicine; the second medicine storage layer (11) stores a second medicine.

10. The microneedle patch with the pressing type double drug storage layers as claimed in claim 9, wherein the microneedle patch with the pressing type double drug storage layers is prepared by the following steps: when in use, the microneedle array (4) sequentially penetrates through the upper surface of the first drug-loaded layer (6), the diaphragm (8) and the second drug-loaded layer (7).

Technical Field

The invention relates to the technical field of medical equipment, in particular to a push type microneedle patch with double drug storage layers.

Background

Alopecia is a common disease that currently exists. The currently used way of treating hair loss is to apply drugs directly to the hair loss area, but the stratum corneum is the physical barrier of the skin and allows only highly lipophilic small molecule substances with molecular weights below 500 daltons to pass through. Therefore, the traditional mode for treating alopecia through skin penetration has low administration efficiency and insignificant effect.

In order to solve the problem of low efficiency of applying medicines to the stratum corneum by the traditional treatment mode, two major modern permeation-promoting technologies, namely chemical permeation-promoting technology and physical permeation-promoting technology, exist at present. Among them, the physics is such as Chinese patent publication No. CN201239422Y, published Japanese 2009.05.20 discloses a special medicine applying device for treating leukotrichia and alopecia, which comprises a medicine applying device body, a medicine applying needle, a medicine tooth head, medicine applying teeth and a sealing plug; the patent combines the medicine feeding needle and the medicine feeding teeth to realize the purpose of promoting the medicine penetration; however, the current physical penetration-enhancing technique causes pain, reduces the compliance of people with the method, and the skin-piercing microchannels do not heal quickly, which is prone to scarring and inflammation. Therefore, there is a need in the art for a treatment device that can solve the problems of low administration efficiency, no pain, and no scar caused by the conventional transdermal alopecia treatment.

Disclosure of Invention

The invention provides a pressing type microneedle patch with double drug storage layers and a preparation method thereof, aiming at solving the problems that the traditional transdermal alopecia treatment mode is low in drug delivery efficiency, does not cause pain and scars, and needs a treatment device.

In order to achieve the purpose of the invention, the technical scheme is as follows:

a microneedle patch with push-type double drug storage layers comprises a pasting layer, a microneedle array module and a drug-carrying layer module, wherein the microneedle array module is installed on the pasting layer, and the drug-carrying layer module is fixedly connected to the microneedle array module.

Preferably, the adhesive layer comprises an inner surface and an outer surface, wherein the inner surface of the adhesive layer is an adhesive surface and the outer surface is a non-adhesive surface; the microneedle array module has a size smaller than that of the adhesive layer and is mounted on the inner surface of the adhesive layer.

Further, the microneedle array module comprises a substrate and a microneedle array; the microneedle array is formed by fixedly connecting the bottom of the microneedle array and the upper surface of the substrate in a direction perpendicular to the substrate.

Furthermore, the first medicine-carrying layer comprises a first medicine storage layer and a first anti-seepage gasket; the first anti-seepage gasket is fixedly connected to the upper surface of the substrate and is fixedly connected with the first medicine storage layer by surrounding the first medicine storage layer; the lower surface of the first medicine storage layer is fixedly connected with the substrate; the microneedle array is fixedly connected with the first drug storage layer by inserting the first drug storage layer

Furthermore, the second medicine-carrying layer comprises a second medicine storage layer and a second anti-seepage gasket; the lower bottom surface of the second anti-seepage gasket is fixedly connected with the upper surface of the diaphragm and fixedly connected with the second medicine storage layer by surrounding the second medicine storage layer.

Furthermore, the first impermeable gasket is of a soft material hollow structure; and the first impermeable gasket height exceeds the microneedle array height.

Furthermore, the second impermeable gasket is a rigid material hollow structure; and the second impermeable gasket is lower than the microneedle array.

Furthermore, the first medicine storage layer and the second medicine storage layer are both made of porous soft materials; the first medicine storage layer stores a first medicine; the second medicine storage layer stores a second medicine.

Further, when in use, the microneedle array sequentially penetrates through the upper surface of the first drug-loaded layer, the diaphragm and the second drug-loaded layer.

The invention has the following beneficial effects:

the invention provides the microneedle therapy patch which integrates three processes of coating, puncturing and transmitting into a whole and improves the absorption efficiency of therapeutic substance components by combining the microneedle array module and the drug-loaded layer module positioned on the microneedle array. Solves the problem that the prior art needs a treatment device which can solve the problems of low administration efficiency, no pain and no scar caused by the traditional alopecia transdermal treatment mode.

Drawings

Fig. 1 is a schematic structural view of the present invention.

FIGS. 2-4 are schematic views illustrating the operation of the present invention.

In the figure, 1-microneedle array module, 2-drug-loaded layer module, 3-substrate, 4-microneedle array, 5-adhesive layer, 6-first drug-loaded layer, 7-second drug-loaded layer, 8-diaphragm, 9-first drug-storage layer, 10-first impermeable gasket, 11-second drug-storage layer, and 12-second impermeable gasket.

Detailed Description

The invention is described in detail below with reference to the drawings and the detailed description.

Example 1

The utility model provides a micropin paster on two medicine storage layers of push type which characterized in that: comprises an adhesive layer 5, a microneedle array module 1 arranged on the adhesive layer 5 and a drug-loaded layer module 2 fixedly connected on the microneedle array module.

The adhesive layer 5 comprises an inner surface and an outer surface, wherein the inner surface of the adhesive layer 5 is an adhesive surface, and the outer surface is a non-adhesive surface; the microneedle array module 1 is smaller in size than the adhesive layer 5 and the microneedle array module 1 is mounted on the inner surface of the adhesive layer 5

The microneedle array module 1 comprises a substrate 3, a microneedle array 4 arranged on the upper surface of the substrate 3 and an adhesive layer 5 arranged on the lower surface of the microneedle array 4; the microneedle array 4 is formed by fixedly connecting the needle bottom of the microneedle array 4 and the upper surface of the substrate in a direction perpendicular to the substrate 3. In this embodiment, the substrate 3 may be made of silica gel, and the adhesive layer 5 may be a medical adhesive tape.

In this embodiment, the microneedle array 4 can be made of metal, biocompatible polymer material such as stainless steel, PMMA material, epoxy resin, and various composite materials with biocompatible coating or plating. Meanwhile, in order to ensure that the cuticle and the epidermis are pierced and the dermis is reached, the length of the microneedle is 1.4 mm, the microneedle is composed of a cylinder with the radius of 0.2 mm and the height of 0.4 mm and a cone with the height of 1 mm, and the distance between every two adjacent microneedles is 1.2 mm.

The drug-loaded layer module 2 comprises a first drug-loaded layer 6, a second drug-loaded layer 7 and a diaphragm 8; the second medicine-carrying layer 7 is positioned above the first medicine-carrying layer 6 and is separated by the diaphragm 8; the lower bottom surface of the second drug-loaded layer 7 is fixedly connected with the upper surface of the diaphragm (8), and the lower surface of the diaphragm 8 is fixedly connected with the upper surface of the first drug-loaded layer 6; the first drug-loaded layer 6 is fixedly connected with the substrate 8 through the lower surface thereof

Furthermore, the first drug-loaded layer 6 comprises a first drug storage layer 9 and a first anti-seepage gasket 10; the first impermeable gasket 10 is fixedly connected to the upper surface of the substrate 3 and fixedly connected with the first medicine storage layer 9 by surrounding the first medicine storage layer 9; the lower surface of the first medicine storage layer 9 is fixedly connected with the substrate 3; the microneedle array 4 is fixedly connected with the first drug storage layer 9 by inserting the first drug storage layer 9.

The second drug-loaded layer 7 comprises a second drug storage layer 11 and a second impermeable gasket 12; the lower bottom surface of the second impermeable gasket 12 is fixedly connected with the upper surface of the diaphragm 8, and the second impermeable gasket 12 is fixedly connected with the second medicament storage layer 11 by surrounding the second medicament storage layer 11.

The first impermeable gasket 10 is soft and is arranged into a hollow structure; and the first impermeable gasket 10 has a height exceeding the height of the microneedle array 4; in this embodiment, the second impermeable gasket may be a soft medical water-absorbing double-sided adhesive tape.

The second impermeable gasket 12 is rigid and is provided in a hollow structure; and the second impermeable gasket 12 is lower than the microneedle array 4; the second impermeable gasket in this embodiment may be a hard medical water-absorbing double-sided adhesive tape.

The first medicine storage layer 9 and the second medicine storage layer 11 are both made of porous soft materials. In this embodiment, the first drug storage layer 9 and the second drug storage layer 11 are made of materials with good biocompatibility, such as porous hydrogel; the first medicine storage layer 9 stores a first medicine; the second medicine storage layer 11 stores a second medicine. In this embodiment, the first and second drugs are typically macromolecular therapeutic drugs such as: finasteride, triamcinolone acetonide, tofacitinib citrate, and the like.

In this embodiment, the first drug reservoir 93 may be loaded with the diffusible drug 1 in a volume of about 150 μ L, and the second drug reservoir 114 may be loaded with the diffusible drug 2 in a volume of about 150 μ L. The first drug is uniformly distributed in the first drug storage layer 9 and released from the porous structure of the first drug storage layer 9, and the second drug is uniformly distributed in the second drug storage layer 11 and released from the porous structure of the second drug storage layer 11.

When in use, the microneedle array 4 sequentially penetrates through the upper surface of the first drug-loaded layer 6, the diaphragm 8 and the second drug-loaded layer 7.

The preparation method comprises the following steps:

s1, preparing a microneedle array 4 by methods such as micro-electro-mechanical processing and micro-mould pressing, wherein a biocompatibility modifier is required to be used for cleaning and disinfecting the surface of the microneedle array 4;

s2, fixedly mounting the lower surface of the first anti-seepage gasket 10 on the upper surface of the substrate 3;

s3, placing a first medicine storage layer 6 added with a first medicine into a hollow area of the first anti-seepage gasket 10;

s4, placing a layer of diaphragm 8 on the upper surface of the first anti-seepage gasket 10 and fixedly connecting the lower surface of the diaphragm 8 with the upper surface of the first medicine-carrying layer 6;

s5, fixedly mounting the lower surface of a second impermeable gasket 12 on the upper surface of the diaphragm 8, and aligning the second impermeable gasket 12 with the upper surface of the first impermeable gasket 10;

s6, placing a second medicine storage layer 7 added with a second medicine into a hollow area of the second impermeable gasket 12;

and S7, adhering the lower surface of the substrate 3 to the center of the adhesive inner surface of the adhesive layer 5.

When the micro-needle array 4 patch is used, the patch is attached to the skin, the adhesive inner surface of the adhesive layer is attached to the surface of the skin, the drug-loaded layer is attached to the surface of the skin by the adhesive layer 5, the outer surface of the external adhesive layer 5 is pressed, and under the action of pressure, the first drug-loaded layer 6 is compressed, so that the needle tops of the micro-needle arrays 4 penetrate through the diaphragm 8 and penetrate through the upper surface of the second drug-loaded layer 7 and penetrate into the skin to form a micro-pore array drug delivery channel. The pressure is removed after the certain time is kept, the first drug-loaded layer 6 restores the original shape after the pressing is finished, the microneedle array 4 exits from the skin and returns to the first drug-loaded layer 6, and the drug in the second drug storage layer 11 is continuously administrated through the micropore administration channel as the second drug-loaded layer 7 contains the drug and is directly contacted with the skin; meanwhile, the drug of the first drug reservoir layer 9 penetrates the membrane and enters the second drug reservoir layer 11 for continuous administration due to piercing of the membrane 8. When the medicine needs to be administered again at an appropriate time interval, the compression is administered again, and the medicine delivery rate and amount can be effectively controlled by the compression frequency, compression time, and the like. The invention solves the problem that the prior art needs a treatment device which can solve the problems of low administration efficiency, no pain and no scar caused by a traditional alopecia transdermal treatment mode by combining the microneedle array module 1 and the drug-loaded layer module 2 positioned on the microneedle array 4.

It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.