CN219332937U - Quick-separation slow-release microneedle patch - Google Patents

Abstract

The utility model relates to the field of medical equipment and discloses a quick-release micro-needle patch which comprises a basal layer, a water-soluble layer and a soluble needle body, wherein the basal layer comprises a first surface and a second surface which are oppositely arranged, the basal layer is provided with a water-permeable hole penetrating through the first surface and the second surface, the water-soluble layer is horizontally arranged along the second surface, at least one water-soluble layer is horizontally arranged on the second surface, and at least one soluble needle body is arranged on the water-soluble layer.

Description

Quick-separation slow-release microneedle patch

Technical Field

The utility model relates to the field of medical instruments, in particular to a rapid-separation slow-release microneedle patch.

Background

The transdermal drug delivery preparation is a dosage form for drug delivery through skin, can avoid the interference of gastrointestinal environment on drug effect and liver first pass effect, maintain constant optimal blood concentration or physiological effect, prolong effective action time, reduce drug administration times, and has independent drug delivery and good compliance. The soluble microneedle as a novel painless transdermal drug delivery technology can create a micron-sized drug transmission channel on skin painlessly, enhance the permeability of skin to active drugs, especially macromolecular active ingredients, and represents the development direction of the transdermal drug delivery in the future due to the advantages of painless, safety, easy operation and the like, and is one of research and development hot spots in the field of transdermal drug delivery. The soluble microneedle drug patch manufactured by the technology solves the problems of low drug conduction efficiency, obvious pain feeling and the like of the existing transdermal drug delivery technology, brings a painless, safe and efficient brand-new transdermal drug delivery mode for consumers, has very obvious economic and social benefits, and is widely applied to the beauty field and the medicine field.

The traditional soluble microneedle patch is characterized in that the added soluble polymer is usually used for being added, after penetrating into the skin, the dissolving rate of the microneedle body is slower, more than several hours are needed for complete dissolution, after the soluble microneedle body is dissolved, the substrate can be torn off, the skin is isolated from air and water for a long time, the skin surface is stuffy and wet, the applied foreign body feel is heavy, the use experience of a user is affected, the patent CNCN105596287B discloses an active separation type soluble microneedle body, a soluble layer is added between the soluble microneedle body and the substrate, the soluble layer is dissolved through absorbing the moisture on the skin surface and tissue fluid oozed out by the skin, so that the separation of the soluble microneedle body and a substrate sheet is completed, however, under the conventional condition, the moisture exhaled by the skin surface is limited, the dissolving rate of the soluble layer is not much faster than the dissolving rate of the needle body, and the rapid separation of the substrate layer and the microneedle body cannot be completed.

Disclosure of Invention

Therefore, it is necessary to provide a rapid-separation slow-release microneedle patch, which solves the problem that the conventional separation microneedle device has a slow dissolution of a soluble layer, so that the slow-release microneedle patch needs to be applied for a long time, and is inconvenient for users to use.

In order to achieve the above object, the present utility model provides a rapid-release sustained-release microneedle patch comprising:

the water permeable membrane comprises a basal layer and a water permeable membrane, wherein the basal layer comprises a first surface and a second surface which are oppositely arranged, and water permeable holes penetrating through the first surface and the second surface are formed in the basal layer;

the water-soluble layer is tiled along the second surface, and at least one water-soluble layer is tiled on the second surface;

and the water-soluble layer is provided with at least one soluble needle body.

The water-soluble layer can be made of hydrophilic macromolecular material, the hydrophilic macromolecular material is dissolved in water, and the hydrophilic macromolecular material can be selected from one or more of carbomer, sodium hydroxymethyl cellulose, hydroxypropyl methylcellulose, pectin, gelatin, alginic acid and poloxamer.

The shape of the soluble needle body can be various shapes which are favorable for penetrating the skin, and the common shape of the needle body of the soluble needle body is cone, pyramid, multi-section cone and bullet-shaped. The soluble needle body is made of a soluble high polymer material, the soluble needle body is loaded with medicines distributed, and after the soluble needle body is penetrated into the skin, the soluble needle body slowly dissolves to play a role of slow release drug delivery, and can also be dissolved to transfer macromolecular compounds into the skin layer, for example, the soluble needle body can be composed of sodium hyaluronate.

Preferably, the second surface is tiled with a layer of water-soluble layer, and the plurality of soluble needle bodies are jointly arranged on the same water-soluble layer. All the water-soluble layers form an integral structure, and when the production is carried out, only a complete water-soluble layer is adhered to the basal layer, so that the production is convenient.

Preferably, a plurality of water-soluble layers are tiled on the second surface, at least one soluble needle body is arranged on each water-soluble layer, and a spacing gap is formed between every two adjacent water-soluble layers. The spacing gap separates the water-soluble layers of a plurality of small blocks, so that the dissolution speed of the water-soluble layers can be increased, and the quick separation of the basal layer and the soluble needle body is facilitated.

Preferably, the area of the water-soluble layer is smaller toward the center of the second surface on the second surface. The water-soluble layer is close to the border position of stratum basale, except the moisture in the hole transport air that permeates water, and the water-soluble layer that is located the central point is more less soluble, in this scheme, toward second surface central point more, the water-soluble layer area is less can guarantee that the dissolution time of water-soluble layer is comparatively unanimous.

Preferably, the shape of the plurality of water-soluble layers on the second surface is one or more of triangle, square, rectangle, parallelogram, pentagon and hexagon.

Preferably, the soluble needle body comprises a drug-carrying needle point and a support separation layer, wherein the support separation layer is connected with the basal layer and the drug-carrying needle point, and the support separation layer is the water-soluble layer. The water-soluble layer becomes a part of the needle body of the soluble needle body, and when the soluble needle body is dissolved and separated, only the water-soluble layer part on the soluble needle body is dissolved, so that the separation of the soluble needle body is quickened.

Preferably, the water absorbing layer is arranged on the basal layer, and the water absorbing layer is contacted with the water soluble layer and the external air at the same time. The water absorption layer has good water absorption effect, can effectively absorb the moisture in the air through the water permeable holes, and guide the moisture to the water-soluble layer so as to accelerate the dissolution of the water-soluble layer.

Preferably, the water absorption layer is tiled on the second surface, the two opposite side surfaces of the water absorption layer are respectively provided with a first water guide strip and a second water guide strip, the first water guide strips are extended and embedded in the water permeable holes, and the second water guide strips are extended and embedded in the water soluble layer. The first water guide strip is used for adsorbing and guiding moisture in the outside air to the water absorption layer, and the second water guide strip is used for guiding the moisture on the water absorption layer into the water soluble layer.

Preferably, the water absorbing layer is embedded in the water soluble layer, a first water guide strip is arranged on the side surface of the water absorbing layer, facing the basal layer, and the first water guide strip extends to be embedded in the water permeable hole. The water absorbing layer is embedded into the water-soluble layer, which is beneficial to the uniform dissolution of the water-soluble layer.

Preferably, the water permeable holes are uniformly or unevenly arranged on the substrate layer. The distribution of the soluble needle arrays on the basal layer can be uniformly or unevenly according to the requirement, and the distribution of the water soluble layer and the water permeable holes corresponds to the distribution of the soluble needle arrays.

Preferably, the water permeable holes are spaced from each other at a smaller distance from each other toward the center of the base layer. Ensures that the dissolution speed of the water-soluble layer paved on the second surface is more consistent, and improves the use experience of the microneedle patch.

Preferably, the central axis of the soluble needle body and the plane of the water-soluble layer have an included angle alpha, and the included angle alpha is in the range of 30 degrees or more and 90 degrees or less. When the included angle alpha is smaller than 90 degrees, the soluble needle body is obliquely arranged, and the micro needle is more difficult to separate from the skin after penetrating into the skin.

Preferably, the water permeable holes are holes of the substrate layer or holes processed by perforation.

Preferably, the diameter of the water permeable hole is 1-300 μm, and the thickness of the water soluble layer is 1-500 μm.

The technical scheme has the following beneficial effects:

in the utility model, the soluble needle body is stuck on the microneedle and is adhered to the basal layer through the water-soluble layer, the water-permeable hole is arranged on the basal layer, when the microneedle is stuck on the skin of a human body, the water-permeable hole on the basal layer can absorb water molecules in the air, and the water-soluble layer can be quickly dissolved after meeting water, so that the basal layer can be separated from the soluble needle body, and the soluble needle body can be torn off and is left in the skin for continuous administration.

Drawings

Fig. 1 is a structural diagram of a microneedle patch according to an embodiment.

Fig. 2 is a cross-sectional view of a microneedle patch according to an embodiment.

FIG. 3 is a distribution of water permeable pores on a first surface of a substrate layer according to an embodiment.

Fig. 4 is a cross-sectional view of a microneedle patch according to an embodiment.

Fig. 5 is a structural diagram of a microneedle patch according to an embodiment.

Fig. 6 is a graph showing a distribution of the water-soluble layer on the second surface according to the embodiment.

Fig. 7 is a graph showing a distribution of the water-soluble layer on the second surface according to the embodiment.

Fig. 8 is a cross-sectional view of a microneedle patch according to an embodiment.

Fig. 9 is a cross-sectional view of a microneedle patch according to an embodiment.

Fig. 10 is a cross-sectional view of a microneedle patch according to an embodiment.

Fig. 11 is a cross-sectional view of a microneedle patch according to an embodiment.

Fig. 12 is a cross-sectional view of a microneedle patch according to an embodiment.

Fig. 13 is a cross-sectional view of a microneedle patch according to an embodiment.

Fig. 14 is a cross-sectional view of a microneedle patch according to an embodiment.

Reference numerals illustrate:

1. a base layer; 11. a first surface; 12. a second surface; 13. a water permeable hole; 2. a water-soluble layer; 21. spacing the void; 3. a dissolvable needle; 31. a drug-carrying needle tip; 32. supporting the separation layer; 4. a water-absorbing layer; 41. a first water guide strip; 42. and a second water guide strip.

Detailed Description

In order to describe the technical content, constructional features, achieved objects and effects of the technical solution in detail, the following description is made in connection with the specific embodiments in conjunction with the accompanying drawings.

Example 1

As shown in fig. 1-3, this embodiment provides a fast-separating sustained-release microneedle patch, which comprises a substrate layer 1, a water-soluble layer 2 and a soluble needle body 3, wherein the substrate layer 1 comprises a first surface 11 and a second surface 12 which are oppositely arranged, a water permeable hole 13 penetrating through the first surface 11 and the second surface 12 is formed in the substrate layer 1, the water-soluble layer 2 is horizontally arranged along the second surface 12, at least one water-soluble layer 2 is horizontally arranged on the second surface 12, and at least one soluble needle body 3 is arranged on the water-soluble layer 2.

The shape of the soluble needle body 3 can be various shapes which are favorable for penetrating the skin, and the common shape of the needle body 3 is cone, pyramid, multi-section cone or bullet-shaped, or can be a combination pattern of various cones. In some embodiments, a single soluble needle sheet may be composed of a single soluble needle 3 or may be composed of soluble needles 3 having different shapes.

The water soluble layer 2 can be made of hydrophilic macromolecular material which is dissolved in water, and the hydrophilic macromolecular material can be one or more selected from carbomer, sodium hydroxymethyl cellulose, hydroxypropyl methylcellulose, pectin, gelatin, alginic acid and poloxamer.

The soluble needle body 3 is made of a soluble high polymer material, drug molecules are distributed in the soluble high polymer material, and after the soluble needle body 3 is penetrated into the skin, the soluble needle body is slowly dissolved, and the component materials of the soluble needle body or the drug loaded on the soluble needle body are slowly transferred into the skin layer. In some embodiments, the soluble high molecular polymer may be hyaluronic acid, sodium hyaluronate, polyvinyl alcohol, polyvinylpyrrolidone, or the like.

In some embodiments, the water permeable holes 13 are uniformly or non-uniformly disposed on the substrate layer. The soluble needle bodies 3 on the substrate layer 1 may be uniformly distributed or unevenly distributed as required.

As shown in fig. 1-2, the soluble needle 3 and the water permeable holes 13 are arranged in a uniform array.

In some embodiments, the soluble needle bodies 3 may be distributed in various forms on the water-soluble layer 2 in an array manner, such as a circular array or a square array, the shapes of the water-soluble layer 2 and the substrate layer 1 may be circular or square, and other polygonal shapes, such as fig. 1-2, the water-soluble layer 2 and the substrate layer 1 are rectangular, the area of the second surface 12 of the substrate layer 1 is larger than that of the water-soluble layer 2, and the surface of the second surface 12, which exceeds the water-soluble layer 2, may be provided as an adhesive surface, so that the product is conveniently applied.

In the finished microneedle patch, as shown in fig. 14, release paper 14 is adhered to the first surface of the base layer 1, the water permeable hole 13 is closed, the release paper 14 is torn off after the soluble needle body 3 is pierced into the skin, the water permeable hole is opened, and the release paper 14 is torn off after the water-soluble layer is dissolved.

In another embodiment, the finished product of the microneedle patch can be packaged in a vacuum-dried environment (such as a packaging bag), and can be taken out when in use.

In some embodiments, as shown in fig. 3, the water permeable holes 13 are spaced from each other at a smaller distance from each other as they go toward the center of the substrate layer 1 on the substrate layer 1. Ensures that the dissolution speed of the water-soluble layer 2 paved on the second surface 12 is more consistent, and improves the use experience of the microneedle patch. In fig. 3, there is shown an annular array of water permeable holes 13, wherein the smaller the gap between the water permeable holes 13, the denser the distribution of the water permeable holes 13.

In some embodiments, the water permeable holes 13 are holes or holes machined by punching, which are provided in the substrate layer 1 itself.

In a specific embodiment, the substrate layer 1 is a flexible plastic sheet with a certain thickness, and the water permeable holes 13 penetrate through the flexible plastic sheet. The water permeable holes 13 may be formed by punching a flexible plastic sheet.

In a specific embodiment, the substrate layer 1 is a nonwoven fabric, and the holes on the nonwoven fabric form the water permeable holes 13 in this embodiment.

In a specific embodiment, the substrate layer 1 is a hydrogel, and the pores of the hydrogel itself form the water permeable pores 13 in this embodiment.

In some embodiments, the substrate layer 1 is a circular sheet and the water permeable holes 13 are arranged in a circular array on the substrate layer.

In some embodiments, the pore size of the water permeable pores 13 is 1-300 μm, and the pore size of a particular water permeable pore 13 may be 1 μm, 10 μm, 50 μm, 100 μm, 120 μm, 150 μm, 180 μm, 200 μm, 220 μm, 250 μm, 280 μm, 300 μm.

In some embodiments, the thickness of the water-soluble layer 2 is 1-500 μm. The thickness of the specific water-soluble layer 2 may be 1 μm, 10 μm, 50 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, 500 μm.

As shown in fig. 1-3, a water-soluble layer 2 is laid on the second surface 12, and all the soluble needle bodies 3 are arranged on the same water-soluble layer 2 in a common array. All the water-soluble layers 2 form an integral structure, and when the water-soluble layer is produced, only one complete water-soluble layer 2 is adhered to the substrate layer 1, so that the water-soluble layer is convenient to produce.

Example 2

As shown in fig. 4-7, this embodiment provides a rapid-release sustained-release microneedle patch, which is different from embodiment 1 in that a plurality of water-soluble layers 2 are tiled on a second surface 12 of a substrate layer 1, at least one soluble needle body 3 is disposed on each water-soluble layer 2, and a space 21 is formed between adjacent water-soluble layers 2. The spacing gap 21 separates the water-soluble layers 2 of a plurality of small blocks, so that the dissolution speed of the water-soluble layers 2 can be increased, and the quick separation of the substrate layer 1 and the soluble needle body 3 is facilitated. As shown in fig. 5, each water-soluble layer 2 comprises two rows of soluble needles 3 on its area.

In some embodiments, the smaller the area of the water-soluble layer 2 on the second surface 12, the further toward the center of the second surface 12. The water-soluble layer 2 is close to the edge position of the basal layer 1, except the water-permeable hole 13 for conveying the water in the air, the edge can also contact the air, so the water-soluble layer 2 at the central position is not easy to dissolve, in the scheme, the smaller the area of the water-soluble layer 2 is, the more towards the central position of the second surface 12 is, and the more consistent the dissolution time of the water-soluble layer 2 is ensured.

As shown in fig. 7, the spacing gaps 21 are distributed in a plurality of concentric diamond shapes, and the smaller the diamond shape is, the smaller the spacing gaps 21 are distributed in the diamond shape.

In some embodiments, the shape of the plurality of water-soluble layers 2 on the second surface 12 is one or more of triangular, square, rectangular, parallelogram, pentagon, and hexagon.

As shown in fig. 6, the plurality of water-soluble layers 2 are divided into hexagonal distribution on the second surface 12 by the space 21.

In some particular embodiments, the second surface 12 has a plurality of small square water soluble layers 2 tiled thereon.

Example 3

As shown in fig. 8, this embodiment provides a rapid-release sustained-release microneedle patch, which is different from embodiment 1 in that the soluble needle body 3 includes a drug-loaded needle tip 31 and a support separation layer 32, the support separation layer 32 connects the substrate layer 1 and the drug-loaded needle tip 31, and the support separation layer 32 is a water-soluble layer 2. When the water-soluble layer 2 becomes a part of the soluble needle body 3 and the micro needle is dissolved and separated, only the part of the water-soluble layer 2 corresponding to the soluble needle body 3 is needed to be dissolved, so that the separation of the soluble needle body 3 and the basal layer is quickened.

Example 4

The central axis of the soluble needle body 3 and the plane of the water-soluble layer 2 have an included angle alpha, and the included angle alpha is more than or equal to 30 degrees and less than or equal to 90 degrees. Specifically, the angle of the included angle α may be 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, 70 °, 75 °, 80 °, 85 °, or 90 °.

In embodiments 1-3, the soluble needle 3 is perpendicular to the water-soluble layer 2, i.e. the included angle α is 90 °, as shown in fig. 9, this embodiment provides a rapid-release slow-release microneedle patch, unlike embodiment 1, in this embodiment, the soluble needle 3 is obliquely disposed, i.e. the included angle α is smaller than 90 °, and when the soluble needle 3 penetrates the skin, the obliquely disposed soluble needle 3 is less likely to separate from the skin.

Example 5

As shown in fig. 10, this embodiment provides a rapid-release sustained-release microneedle patch, which, unlike embodiment 1, further includes a water-absorbent layer 4, the water-absorbent layer 4 being disposed on the second surface 12 of the base layer 1, and water-permeable holes 13 being disposed so as to permeate water through the water-absorbent layer 4 to the water-soluble layer 2. The water absorption layer 4 has good water absorption effect, and can effectively absorb water in the air by contacting the air through the water penetration holes 13 and guide the water to the water-soluble layer 2 so as to accelerate the dissolution of the water-soluble layer 2.

The water-absorbing layer 4 can be a water-absorbing fiber or sponge material, and when the water-absorbing layer 4 contacts the external air through the water-permeable holes 13, water molecules are rapidly guided to the water-soluble layer 2, so that the water-soluble layer 2 is promoted to be rapidly dissolved.

Example 6

As shown in fig. 11, this embodiment provides a rapid-release sustained-release microneedle patch, unlike embodiment 5, the water-absorbent layer 4 is tiled on the second surface 12, two opposite sides of the water-absorbent layer 4 are respectively provided with a first water guiding strip 41 and a second water guiding strip 42, the first water guiding strip 41 is extended and embedded in the water permeable hole 13, and the second water guiding strip 42 is extended and embedded in the water-soluble layer 2. The first water guiding strip 41 is used for absorbing and guiding moisture in the external air to the water absorbing layer 4, and the second water guiding strip 42 is used for guiding the moisture on the water absorbing layer 4 into the water soluble layer 2.

The first water guiding strip 41, the second water guiding strip 42 and the water absorbing layer 4 may be made of the same material, or the hydrophilicity of the first water guiding strip 41, the water absorbing layer 4 and the second water guiding strip 42 may be sequentially enhanced, so that water can be guided into the water soluble layer 2.

In another embodiment, as shown in fig. 12, since the water absorbing layer 4 is disposed in the solution, the capability of the microneedle patch for absorbing water is enhanced, the water absorbing layer 4 can also be beneficial to dispersing water in the water soluble layer 2 everywhere, so as to ensure uniform dissolution of the water soluble layer 2, at this time, the base layer 1 does not need to be provided with too many water permeable holes 13 of the array, as shown in fig. 12, the base layer 1 is provided with several sparse water permeable holes 13, so that the first water guiding strips 41 can be conveniently embedded, and the other surface of the water absorbing layer 4 is provided with a plurality of array second water guiding strips 42, which is beneficial to uniform water guiding.

In this embodiment, the first water guiding strip and the second water guiding strip may have various shapes such as a main body or a cylinder.

In another embodiment, the first water guiding strip may extend to protrude from the first surface of the substrate layer, and be tiled on the first surface to form a plane, so as to increase the contact area with the moisture, and further improve the dissolution rate of the water-soluble layer.

Example 7

As shown in fig. 13, this embodiment provides a rapid-release sustained-release microneedle patch, unlike embodiment 5, the water-absorbent layer 4 is embedded in the water-soluble layer 2, the side of the water-absorbent layer 4 facing the substrate layer 1 is provided with first water guiding strips 41, and the first water guiding strips 41 extend and are embedded in the water-permeable holes 13. The water absorbing layer 4 is embedded into the water soluble layer 2, which is beneficial to the uniform dissolution of the water soluble layer 2.

The utility model is used when:

the user faces the soluble needle body 3 towards the skin of a human body, then applies the soluble needle body 3 to the skin, presses the basal layer 1 forcefully, ensures that the soluble needle body 3 pierces the skin, and then the water in the air can contact with the water-soluble layer 2 through the water-permeable holes 13, thereby accelerating the dissolution of the water-soluble layer 2 and realizing the separation of the basal layer 1 and the soluble needle body 3. In order to accelerate the dissolution rate of the water-soluble layer 2, after application, a user can wet the first surface 11 of the substrate layer 1 with water, increase the water passing through the water-permeable holes 13, improve the separation rate of the substrate layer 1 and the soluble needle body 3, and tear off the substrate layer 1 after the water-soluble layer 2 is dissolved, so that the soluble needle body 2 is left in the skin, and the drug loaded on the soluble needle body or the soluble needle body is slowly dissolved, so that slow release drug delivery is realized, and meanwhile, the substrate layer does not need to be applied on the skin for a long time, and the use experience of the user is improved.

It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or terminal that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or terminal. Without further limitation, an element defined by the statement "comprising … …" or "comprising … …" does not exclude the presence of additional elements in a process, method, article or terminal device comprising the element. Further, herein, "greater than," "less than," "exceeding," and the like are understood to not include the present number; "above", "below", "within" and the like are understood to include this number.

While the embodiments have been described above, other variations and modifications will occur to those skilled in the art once the basic inventive concepts are known, and it is therefore intended that the foregoing description and drawings illustrate only embodiments of the utility model and not limit the scope of the utility model, and it is therefore intended that the utility model not be limited to the specific embodiments described, but that the utility model may be practiced with their equivalent structures or with their equivalent processes or with their use directly or indirectly in other related fields.

Claims (9)

1. A rapid-release, slow-release microneedle patch comprising:

the water permeable membrane comprises a basal layer and a water permeable membrane, wherein the basal layer comprises a first surface and a second surface which are oppositely arranged, and water permeable holes penetrating through the first surface and the second surface are formed in the basal layer;

the water-soluble layer is tiled along the second surface, and at least one water-soluble layer is tiled on the second surface;

a soluble needle body, at least one soluble needle body is arranged on the water soluble layer,

the distance between the water permeable holes on the basal layer is smaller as the water permeable holes go to the central position of the basal layer.

2. The rapid separation slow release microneedle patch of claim 1, wherein the second surface is tiled with a layer of the water-soluble layer, and all of the soluble needle bodies are disposed together on the same water-soluble layer.

3. The rapid separation slow release microneedle patch of claim 1, wherein a plurality of said water-soluble layers are tiled on said second surface, each of said water-soluble layers having at least one soluble needle thereon, and wherein there are spaced-apart gaps between adjacent ones of said water-soluble layers.

4. A rapid release slow release microneedle patch according to claim 3, wherein the water soluble layer area is smaller on the second surface toward the center of the second surface.

5. The rapid separation slow release microneedle patch of claim 1, wherein the dissolvable needle comprises a drug loaded needle tip and a support separation layer, the support separation layer connecting the substrate layer and the drug loaded needle tip, the support separation layer being the water-soluble layer.

6. The rapid release, slow release microneedle patch of claim 1, further comprising a water-absorbing layer disposed on the substrate layer, the water-absorbing layer contacting both the water-soluble layer and the ambient air.

7. The rapid separation slow release microneedle patch of claim 6, wherein the water absorbing layer is tiled on the second surface, wherein the opposite sides of the water absorbing layer are respectively provided with a first water guiding strip and a second water guiding strip, the first water guiding strip extends and is embedded in the water permeable hole, and the second water guiding strip extends and is embedded in the water soluble layer.

8. The rapid separation slow release microneedle patch of claim 6, wherein the water absorbing layer is embedded in the water soluble layer, a side of the water absorbing layer facing the substrate layer is provided with a first water guiding strip, and the first water guiding strip extends and is embedded in the water permeable hole.

9. The rapid separation slow release microneedle patch of any one of claims 1-8, wherein the central axis of the dissolvable needle body has an included angle α with the plane of the water soluble layer, the included angle α being in the range of 30 ° or more and 90 ° or less.

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