Medicine patch and medicine controlled release method

Abstract

The invention discloses a medicine patch and a medicine controlled release method, and belongs to the technical field of clinical medicine. The medicine patch comprises a substrate, a microneedle assembly arranged at the bottom of the substrate and a controlled release layer arranged at the top of the substrate, the controlled release layer can release medicine to the microneedle assembly layer at a first speed, then the microneedle assembly layer can penetrate through the cuticle of the skin and deliver the medicine to the corium layer of the skin, and diffusion of the medicine to the skin is completed; therefore, the medicine diffusion efficiency can be improved without depending on a chemical penetration enhancer, and skin irritation is avoided. And the controlled release layer can also control the first speed of releasing the medicine to the microneedle assembly layer according to the skin state, so that the effect of dynamically controlling the medicine release is realized.

Description

Technical Field

[0001] The present application belongs to the field of clinical medical technology, and in particular relates to a drug patch and a drug controlled release method. Background Art

[0002] Drug patches (transdermal drug delivery systems) can achieve sustained release by utilizing drug diffusion within a polymer matrix. Related art drug patches rely on passive diffusion, which is inefficient in penetrating the stratum corneum and requires chemical penetration enhancers, which can cause skin irritation. Furthermore, related art drug patches cannot dynamically control drug release based on skin conditions. Summary of the Invention

[0003] The present application aims to solve at least one of the technical problems existing in the prior art. To this end, the present application proposes a drug patch and a drug controlled release method that can improve drug diffusion efficiency without relying on chemical penetration enhancers, avoid causing skin irritation, and can achieve dynamic controlled drug release based on skin conditions.

[0004] In a first aspect, the present application provides a drug patch, comprising:

[0005] a microneedle assembly layer disposed at the bottom of the substrate;

[0006] A controlled-release layer is provided on top of the substrate, and the controlled-release layer can release the drug to the microneedle component layer at a first rate. The microneedle component layer can penetrate the stratum corneum of the skin and deliver the drug to the dermis of the skin, wherein the controlled-release layer can adjust the first rate according to the skin condition.

[0007] In some embodiments, the controlled-release layer is formed with a drug storage cavity and a drug release port that are connected to each other, the drug storage cavity is used to store the drug, the drug release port is located on the side of the controlled-release layer close to the substrate, and the controlled-release layer releases the drug to the microneedle assembly layer through the drug release port;

[0008] The volume of the medicine storage cavity is adjusted according to the skin condition to adjust the first rate.

[0009] In some embodiments, the volume of the drug storage cavity decreases as the skin temperature increases to increase the first rate.

[0010] In some embodiments, the plurality of drug release ports are arranged along a first direction and a second direction on a side of the controlled-release layer close to the substrate, and the first direction and the second direction are parallel to the substrate.

[0011] In some embodiments, the drug storage cavity is divided into several independent sub-drug storage cavities by a diaphragm, and the several sub-drug storage cavities are used to store different drugs.

[0012] In some embodiments, the numbers of the drug release openings corresponding to the two drug storage sub-cavities are not equal.

[0013] In some embodiments, the controlled-release layer includes a drug storage layer and a biofeedback layer stacked sequentially in a direction away from the substrate, the drug storage layer is formed with a connected drug storage cavity and a drug release port, the drug storage cavity is used to store the drug, the drug release port is located on the side of the drug storage layer close to the substrate, and the drug storage layer releases the drug to the microneedle assembly layer through the drug release port;

[0014] The biofeedback layer has a biosensor, a controller and a microcontrol circuit. The biosensor can detect the skin condition and send the skin condition information to the controller. The controller can adjust the size of the microcurrent applied by the microcontrol circuit to the drug according to the skin condition information to adjust the first rate.

[0015] In some embodiments, the biosensor can detect at least one of temperature, humidity, and pH of the skin.

[0016] In some embodiments, the microneedle assembly layer includes a plurality of microneedles arranged along a third direction and a fourth direction, wherein the third direction and the fourth direction are parallel to the substrate, and the ends of the microneedles away from the substrate have a first distance to the substrate, and at least some of the microneedles have unequal first distances.

[0017] In a second aspect, the present application provides a method for controlled drug release, which is applied to a drug patch, wherein the drug patch comprises a substrate, a microneedle assembly layer disposed at the bottom of the substrate, and a controlled release layer disposed at the top of the substrate, wherein the controlled release layer can release the drug to the microneedle assembly layer at a first rate, and the microneedle assembly layer can penetrate the stratum corneum of the skin and deliver the drug to the dermis of the skin, the method comprising:

[0018] If the skin condition changes, the first rate is adjusted.

[0019] The present application provides a drug patch and a controlled drug release method. The drug patch includes a substrate, a microneedle assembly disposed at the bottom of the substrate, and a controlled release layer disposed at the top of the substrate. The controlled release layer can release the drug to the microneedle assembly layer at a first rate. The microneedle assembly layer can then penetrate the stratum corneum of the skin and deliver the drug to the dermis of the skin, completing the diffusion of the drug into the skin. This improves the drug diffusion efficiency without relying on chemical penetration enhancers and avoids causing skin irritation. The controlled release layer can also control the first rate of drug release to the microneedle assembly layer based on the skin condition, thereby achieving the effect of dynamic controlled drug release.

[0020] Additional aspects and advantages of the present application will be given in part in the description below, and in part will become obvious from the description below, or will be learned through practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above and / or additional aspects and advantages of the present application will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

[0022] Figure 1 is a schematic cross-sectional view of a drug patch provided in an embodiment of the present application;

[0023] Figure 2 is a schematic cross-sectional view of another drug patch provided in an embodiment of the present application;

[0024] Figure 3 This is a schematic cross-sectional view of another drug patch provided in an embodiment of the present application.

[0025] Figure 4 This is a schematic cross-sectional view of another drug patch provided in an embodiment of the present application:

[0026] Figure 5 is a schematic cross-sectional view of another drug patch provided in an embodiment of the present application;

[0027] Figure 6 This is a schematic flow chart of the drug controlled release method provided in the examples of the present application. DETAILED DESCRIPTION

[0028] The following describes in detail embodiments of the present application. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application and are not to be construed as limiting the present application.

[0029] Unless otherwise specified, the front-to-back direction in this application is the longitudinal direction of the drug patch, i.e., the X direction; the left-right direction is the transverse direction of the drug patch, i.e., the Y direction; and the up-down direction is the vertical direction of the drug patch, i.e., the Z direction.

[0030] Drug patches (transdermal drug delivery systems) can achieve sustained release by utilizing the diffusion of drugs in a polymer matrix. Lidocaine has a large molecular weight and limited lipid solubility. Drug patches of related technologies rely on passive diffusion, which is not efficient enough to penetrate the stratum corneum and requires chemical penetration enhancers, such as laurocapram. Chemical penetration enhancers may cause skin irritation. Studies have shown that only about 3% of lidocaine in traditional lidocaine patches is absorbed systemically, and more than 95% remains in the patch, resulting in excessively high local concentrations and limited systemic efficacy. In addition, drug patches of related technologies cannot achieve dynamic controlled release of drugs according to skin conditions.

[0031] In view of this, the present application provides a drug patch and a drug controlled release method, which can improve drug diffusion efficiency without relying on chemical penetration enhancers, avoid causing skin irritation, and can achieve dynamic controlled drug release according to skin conditions.

[0032] In a first aspect, the present invention provides a drug patch. Figure 1 This is a schematic cross-sectional view of a drug patch provided in an embodiment of the present application. Figure 1 As shown, the drug patch includes a substrate 10, a microneedle assembly layer 20 disposed at the bottom of the substrate 10, and a controlled release layer 30 disposed on the top of the substrate 10. In other words, the microneedle assembly layer 20, the substrate 10, and the controlled release layer 30 of the drug patch are stacked and distributed in a bottom-to-top direction (direction Z).

[0033] The substrate 10 may include a base layer 101 and an adhesive layer 102 . The base layer 101 may be cylindrical, and the adhesive layer 102 may be ring-shaped. The adhesive layer 102 is attached to the bottom of the base layer 101 .

[0034] Substrate layer 101 serves as the substrate of the entire drug patch. Substrate layer 101 can be made of a breathable and water-permeable non-woven fabric or a porous hydrogel. The porous hydrogel is also breathable and water-permeable. Therefore, the drug released from controlled-release layer 30 can pass through substrate 10 and be released into microneedle assembly layer 20.

[0035] The adhesive layer 102 may have adhesive material on both sides, so that the side of the adhesive layer 102 facing the substrate layer 101 is adhered to the substrate layer 101 through the adhesive material, and the side of the adhesive layer 102 facing away from the substrate layer 101 is adhered to the skin through the adhesive material, thereby achieving the goal of adhering the drug patch to the skin and preventing the drug patch from falling off.

[0036] Figure 1 The microneedle assembly layer 20 is equivalent to being disposed at the bottom of the adhesive layer 102, and the end of the microneedle assembly layer 20 can protrude from the side of the adhesive layer 102 facing away from the substrate layer 101. In this way, when the adhesive material is attached to the skin, the microneedle assembly layer 20 can penetrate the skin layer. The end of the microneedle assembly layer 20 can also not protrude from the side of the adhesive layer 102 facing away from the substrate layer 101. When the adhesive material is attached to the skin, a force toward the skin surface can be applied to the middle of the drug patch, while the adhesive layer 102 is not subjected to this force, causing the drug patch to bend toward the skin. In this way, the microneedle assembly layer 20 can also penetrate the skin layer.

[0037] Because substrate 10 is made of a breathable and water-permeable material, the controlled-release layer located on top of substrate 10 can release the drug at a first rate toward microneedle assembly layer 20. Microneedle assembly layer 20 then penetrates the stratum corneum of the skin and delivers the drug to the dermis. This improves drug diffusion efficiency without relying on chemical penetration enhancers.

[0038] In addition, the controlled-release layer 30 of the embodiment of the present application can adjust the first rate according to the skin condition, that is, the controlled-release layer 30 can adjust the rate at which the microneedle assembly layer 20 releases the drug according to the skin condition, thereby achieving dynamic controlled release of the drug.

[0039] The drug patch provided herein includes a substrate 10, a microneedle assembly layer 20 disposed at the bottom of the substrate 10, and a controlled-release layer 30 disposed at the top of the substrate. The controlled-release layer 30 can release the drug to the microneedle assembly layer 20 at a first rate. The microneedle assembly layer 20 can then penetrate the stratum corneum of the skin and deliver the drug to the dermis of the skin, completing the diffusion of the drug into the skin. This improves the drug diffusion efficiency without relying on chemical penetration enhancers and avoids causing skin irritation. The controlled-release layer 30 can also control the first rate of drug release to the microneedle assembly layer 20 based on the skin condition, thereby achieving the effect of dynamic controlled drug release.

[0040] There are several different ways to implement the controlled-release layer 30 to adjust the first rate according to the skin condition.

[0041] In some embodiments, see Figure 1 , Figure 1 The controlled-release layer 30 is formed with a connected drug reservoir 301 and a drug release port 302. The drug reservoir 301 is used to store the drug, and the drug release port 302 is located on the side of the controlled-release layer 30 close to the substrate 10. Therefore, the controlled-release layer 30 can release the drug to the microneedle assembly layer 20 through the drug release port 302. In other words, the drug in the drug reservoir 301 flows through the drug release port 302, reaches the substrate layer 101, and then passes through the substrate layer 101 to reach the microneedle assembly layer 20. The microneedle assembly layer 20 penetrates the stratum corneum of the skin and finally delivers the drug to the dermis of the skin, completing drug diffusion.

[0042] Figure 1 The volume of the drug storage cavity 301 shown can be adjusted according to the skin condition, thereby adjusting the first rate. Specifically, the controlled-release layer 30 can be made of at least one of a temperature-sensitive material, a pH-sensitive material, and a humidity-sensitive material.

[0043] When one of the skin's temperature, pH, or humidity changes, the controlled-release layer 30 expands. This expansion compresses the drug storage cavity 301, reducing its volume. The drug stored in the drug storage cavity 301 is then squeezed out of the cavity 301, thereby increasing the initial rate of drug release from the drug release port 302. This achieves the effect of dynamically adjusting the drug release rate based on skin conditions.

[0044] For example, the controlled-release layer 30 can be made of a temperature-sensitive material (e.g., poloxamer). When the skin temperature rises, the controlled-release layer 30 undergoes a phase change as the temperature rises. Specifically, the controlled-release layer 30 expands. After the controlled-release layer 30 expands, it squeezes the drug storage cavity 301, reducing the volume of the drug storage cavity 301. The drug stored in the drug storage cavity 301 is squeezed out of the drug storage cavity 301, thereby increasing the first rate of drug release from the drug release port 302.

[0045] Controlled-release layer 30 can also be made of a pH-sensitive hydrogel (e.g., sodium polyacrylate). When the skin's pH rises (due to increased concentrations of skin inflammatory markers), the sensitive hydrogel swells. This expansion compresses drug reservoir 301, reducing its volume. The drug stored in drug reservoir 301 is squeezed out of it, thereby increasing the initial release rate of the drug from release port 302 and relieving acute pain.

[0046] In some embodiments, a plurality of drug release openings 302 are arranged along a first direction and a second direction on a side of the controlled-release layer 30 near the substrate 10, with the first direction and the second direction being parallel to the substrate. Specifically, the first direction and the second direction are parallel to the X-direction. The first direction and the second direction can be perpendicular to each other or form a non-perpendicular angle. This formation of a patch of drug release openings 302 can improve drug release efficiency.

[0047] In some embodiments, the pore sizes of the drug release openings 302 can vary. For example, the pore size of the drug release openings 302 located in the center of the controlled-release layer 30 is relatively large, while the pore size of the pores located at the edge of the controlled-release layer 30 is relatively small. In other words, the pore sizes of the drug release openings 302 gradually decrease from the center to the edge. This allows the drug to be released in a concentrated manner in the center, reducing drug waste.

[0048] In some embodiments, as Figure 2As shown, the shape of the drug storage cavity 301 can also be set to an irregular shape, which can increase the volume of the drug storage cavity 301 and the amount of drug contained. It can also make the liquid flow channel of the drug release port 302 located in the middle of the controlled release layer 30 shorter, making it easier for the drug to flow out of the drug release port 302 located in the middle of the controlled release layer 30. This structure makes it easier for the drug to be released in the middle.

[0049] In some embodiments, the drug storage cavity 301 can be divided into several independent sub-drug storage cavities by a diaphragm 305, and the several sub-drug storage cavities are used to store different drugs. In this way, different drugs can be stored in the several sub-drug storage cavities. In addition, the number of drug release ports corresponding to the several independent sub-drug storage cavities is unequal, or the drug release ports corresponding to the several independent sub-drug storage cavities have different pore sizes, so that different drugs can be released into the microneedle assembly layer 20 at different rates.

[0050] For example, Figure 3 As shown, drug storage cavity 301 is divided into two independent sub-drug storage cavities by diaphragm 305, each storing drug A and drug B. The sub-drug storage cavity corresponding to drug A has fewer drug release openings 302 or smaller pore sizes, while the sub-drug storage cavity corresponding to drug B has more drug release openings 302 or larger pore sizes. Based on this structure, the release rate of drug B is greater than that of drug A.

[0051] This structure can also be set as a quick-release layer and a slow-release layer. Figure 3 The two sub-drug storage chambers shown both store drug A. The left sub-drug storage chamber has fewer drug release openings 302 or smaller diameter drug release openings 302, while the right sub-drug storage chamber has more drug release openings 302 or larger diameter drug release openings 302. Therefore, the left sub-drug storage chamber is a sustained-release zone, and the right sub-drug storage chamber is a rapid-release zone.

[0052] In some embodiments, the controlled-release layer 30 includes a drug storage layer 303 and a biofeedback layer 304 stacked in sequence in a direction away from the substrate, the drug storage layer 303 is formed with a connected drug storage cavity 301 and a drug release port 302, the drug storage cavity 301 is used to store the drug, and the drug release port 302 is located on the side of the drug storage layer 303 close to the substrate 10, and the drug storage layer 303 releases the drug to the microneedle assembly layer 20 through the drug release port 302.

[0053] The biofeedback layer 304 includes a biosensor 3041, a controller 3042, and a microcontroller circuit 3043. The biosensor 3041 can detect skin conditions and transmit the skin condition information to the controller 3042. The controller 3042 can adjust the magnitude of the microcurrent applied to the drug by the microcontroller circuit 3043 based on the skin condition information to adjust the first rate. The biosensor 3041 can detect at least one of skin temperature, humidity, and pH.

[0054] It should be noted that biosensor 3041 can be a temperature sensor, a humidity sensor, or a pH sensor, or a combination of these sensors. In this way, biosensor 3041 can simultaneously detect at least one of skin temperature, humidity, and pH. In embodiments of the present application, biosensor 3041 can be a flexible biosensor (e.g., a graphene electrode array) that can monitor skin temperature, pH, and inflammatory markers in real time.

[0055] For example, biosensor 3041 can be a temperature sensor, and thus can detect skin temperature. When the skin temperature increases, biosensor 3041 detects the temperature increase, generates a temperature increase signal, and then transmits the temperature increase signal to controller 3042. Controller 3042 processes the temperature increase signal and transmits the processed signal to microcontroller circuit 3043.

[0056] The processed signal can be a current increase signal. Based on the current increase signal, the microcontrol circuit 3043 adjusts the magnitude of the microcurrent applied to the drug in the drug reservoir 301 (the microcontrol circuit is electrically connected to the drug, for example, via conductive silver glue). Specifically, the magnitude of the applied microcurrent can be increased to increase the first rate of drug flow into the microneedle assembly layer 20.

[0057] The controller 3042 of the embodiment of the present application adjusts the magnitude of the microcurrent applied to the drug by the microcontrol circuit 3043 according to the skin state information to adjust the first rate based on iontophoresis technology. Iontophoresis is a physical process in which an ion flow diffuses in a medium driven by an electric field force. The microcurrent applied by the microcontrol circuit 3043 to the drug can be applied continuously or in the form of pulses, so that the drug can be released to the dermis in the form of pulses to adapt to patients with different pain thresholds. In addition, by microcurrent (0.1-0.5mA / cm 2 ) drives the directional migration of charged drug molecules, breaking through the traditional 600Da molecular weight limit and supporting the transdermal absorption of large molecule drugs.

[0058] It should be noted that the first rate can be adjusted by adjusting the magnitude of the microcurrent in the present embodiment. The first rate can also be adjusted by adjusting the aperture size of the drug release port 302. For example, a microelectromechanical system (MEMS) can be added to the biofeedback layer. The MEMS includes a micromotor and a micromechanical structure. The controller 3042 adjusts the aperture size of the drug release port 302 by controlling the micromotor and the micromechanical structure.

[0059] In some embodiments, the microneedle assembly layer 20 includes a plurality of microneedles 201 arranged along a third direction and a fourth direction, wherein the third direction and the fourth direction are parallel to the substrate. The third direction and the fourth direction may be parallel to the direction X. The third direction may be the same as the first direction, and the fourth direction may be the same as the second direction.

[0060] The end of the microneedle 201 away from the substrate 10 has a first distance d from the substrate 10, and at least some of the microneedles 201 have different first distances d. Figure 5 As shown, the microneedle assembly layer 20 has two types of microneedles 201 with a first distance d, and the two types of microneedles 201 with the first distance d are staggered on the bottom of the substrate 10. In this way, the microneedle assembly layer 20 can adapt to the uneven skin surface, and more microneedles 201 can penetrate the stratum corneum of the skin and deliver the drug to the dermis of the skin, thereby improving the diffusion efficiency of the drug.

[0061] The microneedle 201 of the embodiment of the present application can be a soluble microneedle array made of a highly stable material such as isomalt, with a needle body height of about 200-800 μm and a tip drug loading of more than 60%. Alternatively, lidocaine can be encapsulated in liposomes / nanogels (e.g., hydroxypropyl cellulose-liposome composite carriers). The microneedle 201 penetrates the stratum corneum to form microchannels, directly delivering drugs to the dermis, circumventing traditional passive diffusion limitations. Nanocarriers improve the transdermal efficiency of fat-soluble drugs and reduce dependence on chemical penetration enhancers. The microneedle assembly layer 20 can be combined with the substrate 10 (elastic fabric or breathable membrane) through a biocompatible adhesive (such as polyacrylates) to ensure the stability of the application.

[0062] The base 10 can be made of elastic cloth or silicone film, and the adhesive layer uses a styrene-isoprene-styrene (SIS) copolymer and a tackifying resin compound (drug loading capacity of 700 mg / patch). It provides breathability and adhesion stability (adhesion force ≥ 1.5 N / cm 2 ), reducing the shedding of the drug patch caused by exercise or sweating.

[0063] Based on the structure of the drug patch of the present application, the drug loading capacity of a single drug patch can also be increased. A single patch with a drug loading of 400mg can achieve the therapeutic effect of a traditional patch of 700mg, the drug utilization rate is increased by 50%, and the residual amount of waste patches is reduced to 20mg (traditionally 665mg), reducing the risk of accidental contact by children or pets. The systemic absorption rate is increased to 15%-20% (traditionally only 3%), reducing skin irritation caused by local high concentrations and reducing the risk of systemic toxicity.

[0064] In some embodiments, the biofeedback layer 304 can also be provided with an alarm device, for example, a miniature alarm signal light can be provided. When the biosensor 3041 detects a change in skin condition, the controller 3042 can control the miniature alarm signal light to sound an alarm, or send an alarm to an external device (such as a smart device) via Bluetooth to reduce the risk of skin irritation.

[0065] In some embodiments, the embodiments of the present application may also provide an APP corresponding to the medicine patch. The user may download the APP corresponding to the medicine patch on a smart device and then use the APP to control the use of the medicine patch.

[0066] For example, the controller 3042 can send the current skin state data to the APP corresponding to the drug patch, for example, sending the current skin state data to the APP corresponding to the drug patch at a preset frequency. The user can view the current skin state data on the APP corresponding to the drug patch. Then, based on the current skin state data, choose whether to adjust the first rate. The first rate can also be specifically set based on the current skin state data. This meets the requirements of drug release at multiple rates, for example, chronic pain requires sustained release of drugs, while anesthesia requires rapid release of drugs.

[0067] In a second aspect, an embodiment of the present application provides a method for controlled drug release, which is applied to a drug patch. The drug patch includes a substrate 10, a microneedle assembly layer 20 disposed at the bottom of the substrate 10, and a controlled release layer 30 disposed on the top of the substrate 10. The controlled release layer 30 can release the drug to the microneedle assembly layer 20 at a first rate. The microneedle assembly layer 20 can penetrate the stratum corneum of the skin and deliver the drug to the dermis of the skin. The method includes:

[0068] Step S101, if the skin condition changes, adjust the first rate;

[0069] Step S102: If the skin condition has not changed, the first rate is not adjusted.

[0070] Therefore, the controlled-release layer 30 can control the first rate of drug release to the microneedle assembly layer 20 according to the skin condition, thereby achieving the effect of dynamic controlled drug release.

[0071] The terms "first," "second," and the like in the specification and claims of this application are used to distinguish similar objects, and are not used to describe a specific order or precedence. It should be understood that the terms used in this manner are interchangeable where appropriate, so that the embodiments of this application can be implemented in an order other than that illustrated or described herein, and that the objects distinguished by "first," "second," and the like are generally of the same type, and do not limit the number of objects; for example, the first object can be one or more. In addition, the term "and / or" in the specification and claims refers to at least one of the connected objects, and the character " / " generally indicates that the objects connected are in an "or" relationship.

[0072] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0073] In the description of this application, "first feature" and "second feature" may include one or more of the features.

[0074] In the description of this application, “plurality” means two or more.

[0075] In the description of the present application, a first feature being “on” or “under” a second feature may include the first and second features being in direct contact with each other, or the first and second features being in contact with each other not directly but via another feature therebetween.

[0076] In the description of this application, a first feature “on”, “above” and “above” a second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature.

[0077] Throughout this specification, reference to terms such as "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples" means that the specific features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

[0078] Although the embodiments of the present application have been shown and described, those skilled in the art will appreciate that various changes, modifications, substitutions, and variations may be made to the embodiments without departing from the principles and intent of the present application, and that the scope of the present application is defined by the claims and their equivalents.

Claims

1. A drug patch, characterized in that: include: substrate; a microneedle assembly layer disposed at the bottom of the substrate; A controlled-release layer is provided on top of the substrate, and the controlled-release layer can release the drug to the microneedle component layer at a first rate. The microneedle component layer can penetrate the stratum corneum of the skin and deliver the drug to the dermis of the skin, wherein the controlled-release layer can adjust the first rate according to the skin condition.

2. The drug patch according to claim 1, characterized in that The controlled-release layer is formed with a drug storage cavity and a drug release port that are connected to each other, the drug storage cavity is used to store the drug, the drug release port is located on the side of the controlled-release layer close to the substrate, and the controlled-release layer releases the drug to the microneedle assembly layer through the drug release port; The volume of the drug storage cavity is adjusted according to the skin condition to adjust the first rate.

3. The drug patch according to claim 2, characterized in that The volume of the drug storage cavity decreases as the skin temperature increases, so as to increase the first rate.

4. The drug patch according to claim 2, characterized in that The drug release ports are arranged along a first direction and a second direction on a side of the controlled-release layer close to the substrate, and the first direction and the second direction are parallel to the substrate.

5. The drug patch according to claim 4, characterized in that The drug storage cavity is divided into a plurality of independent sub-drug storage cavities by a diaphragm, and the plurality of sub-drug storage cavities are used to store different drugs.

6. The drug patch according to claim 5, characterized in that The numbers of the drug release openings correspondingly arranged in the two drug storage sub-cavities are not equal.

7. The drug patch according to claim 1, characterized in that The controlled-release layer includes a drug storage layer and a biofeedback layer stacked in sequence in a direction away from the substrate, wherein the drug storage layer is formed with a drug storage cavity and a drug release port that are connected to each other, wherein the drug storage cavity is used to store the drug, and the drug release port is located on a side of the drug storage layer close to the substrate, and the drug storage layer releases the drug to the microneedle assembly layer through the drug release port; The biofeedback layer has a biosensor, a controller and a microcontrol circuit. The biosensor can detect the skin condition and send the skin condition information to the controller. The controller can adjust the size of the microcurrent applied by the microcontrol circuit to the drug according to the skin condition information to adjust the first rate.

8. The drug patch according to claim 5, characterized in that The biosensor can detect at least one of temperature, humidity, and pH of the skin.

9. The drug patch according to claim 1, characterized in that: The microneedle assembly layer includes a plurality of microneedles arranged along a third direction and a fourth direction, wherein the third direction and the fourth direction are parallel to the substrate, and the ends of the microneedles away from the substrate have a first distance to the substrate, and at least some of the microneedles have unequal first distances.

10. A drug controlled release method, characterized in that: The method is applied to a drug patch, which includes a substrate, a microneedle assembly layer disposed at the bottom of the substrate, and a controlled-release layer disposed at the top of the substrate, wherein the controlled-release layer can release a drug to the microneedle assembly layer at a first rate, and the microneedle assembly layer can penetrate the stratum corneum of the skin and deliver the drug to the dermis of the skin. The method includes: If the skin condition changes, the first rate is adjusted.

Images