System for preparing microneedle patch

Abstract

The utility model provides a system for preparing a microneedle patch, and the system sequentially comprises a unit for forming a groove array, which is used for forming the groove array on a microneedle patch substrate; the raw material injection unit is used for injecting raw materials in the groove array; the electric lifting unit is used for conducting electric lifting on the groove array containing the raw materials to form the microneedle patch, the system can rapidly and continuously prepare the microneedle patch, batch preparation is achieved, operation is easy, and the microneedle patch with the larger area can be prepared.

Description

Technical Field

[0001] This utility model relates to the field of biomedical materials technology, and in particular to a system for rapidly and in batches preparing large-area microneedle patches using roll-to-roll and electro-lifting techniques. Background Technology

[0002] Microneedles are an emerging and effective transdermal drug delivery technology. Soluble and biodegradable microneedle patches based on polymer materials have been widely used in transdermal drug delivery and other fields in recent years. Currently, commonly used methods for preparing polymer material microneedle patches include molding, mechanical lifting, and 3D or 4D printing; however, these methods suffer from problems such as low preparation efficiency, high cost, complex processes, and inability to achieve mass production or continuous manufacturing. Summary of the Invention

[0003] To address the technical problems existing in the prior art, this utility model provides a system for preparing microneedle patches, which is based on roll-to-roll and electro-lifting technology, and can prepare microneedle patches in a large area and continuously.

[0004] The specific technical solution of this utility model is as follows:

[0005] This invention provides a system for preparing microneedle patches, which comprises, in sequence:

[0006] A unit for forming a groove array, used to form a groove array on a microneedle patch substrate;

[0007] A unit for injecting raw materials, used for injecting raw materials into a groove array; and

[0008] An electro-lifting unit is used to electro-lift an array of grooves containing raw materials to form microneedle patches.

[0009] Preferably, in the system described above, the unit for forming the groove array includes a pair of rotating shafts, which are respectively disposed on both sides of the substrate, and one of the rotating shafts is provided with a boss array at intervals for forming a groove array on the microneedle patch substrate.

[0010] Preferably, in the system described above, the electric lifting unit includes a first detection device, a first high-voltage device, and a first rotating device with an array of electrode needles;

[0011] The first rotating device is used to fully align the electrode needle array with the groove array containing raw material that has been rotated to the electric lifting unit;

[0012] The first high-pressure device is used to form the raw material in the groove array into a liquid cone shape;

[0013] The first detection device is used to detect whether the electrode needle array is completely aligned with the groove array containing raw material that is rotated to the electric lifting unit.

[0014] Preferably, in the system described above, the system further includes a curing unit for curing the array of liquid cones after electrolifting to form microneedle patches.

[0015] Preferably, in the system described above, the curing and molding unit includes a second detection device, a second high-pressure device, and a second rotating device equipped with an electrode needle array;

[0016] The second rotating device is used to fully align the electrode needle array with the liquid cone-shaped array that has been rotated to the curing unit;

[0017] The second high-pressure device is used to maintain the shape of the liquid cone;

[0018] The second detection device is used to detect whether the electrode needle array is completely aligned with the array of liquid cone shapes that rotate to the curing unit.

[0019] Preferably, for any of the above-described systems, the system further includes a heating device for curing the array of liquid cones, preferably the heating device is located on one side of the microneedle patch substrate and is opposite to the electric lifting unit and the curing unit, respectively.

[0020] Preferably, for any of the above-described systems, the system further includes a cutting unit for cutting the cured microneedle array into microneedle patches.

[0021] Preferably, for any of the systems described above, the system further includes a surface treatment unit for surface treating the formed groove array.

[0022] Preferably, for any of the above-described systems, the system further includes a plurality of supporting rotation shafts for supporting the substrate forming the microneedle patch.

[0023] This invention discloses a method for preparing microneedle patches, which includes the following steps:

[0024] A groove array is formed on a microneedle patch substrate using units that form a groove array;

[0025] The material is injected into the groove array using the injection material unit; and

[0026] Electro-lifting units are used to electro-lift an array of grooves containing raw materials to form microneedle patches.

[0027] Preferably, in the method described above, the unit for forming the groove array includes a pair of rotating shafts, which are respectively disposed on both sides of the substrate, and one of the rotating shafts is provided with a boss array at intervals to form a groove array on the microneedle patch substrate.

[0028] Preferably, in the method described above, the electric lifting unit includes a first detection device, a first high-voltage device, and a first rotating device with an array of electrode needles;

[0029] The first rotating device is used to fully align the electrode needle array with the groove array containing raw material that has been rotated to the electric lifting unit;

[0030] The first high-pressure device is used to shape the raw material in the groove array into a liquid cone shape;

[0031] The first detection device is used to detect whether the electrode needle array is completely aligned with the groove array containing raw material that is rotated to the electric lifting unit.

[0032] Preferably, in the method described above, the method further includes using a curing unit to cure and shape the array of liquid cones after electrolifting to form microneedle patches.

[0033] Preferably, in the method described above, the curing and molding unit includes a second detection device, a second high-pressure device, and a second rotating device equipped with an electrode needle array;

[0034] The second rotating device is used to fully align the electrode needle array with the liquid cone-shaped array that has been rotated to the curing unit;

[0035] A second high-pressure device is used to maintain the shape of the liquid cone;

[0036] The second detection device is used to detect whether the electrode needle array is completely aligned with the array of liquid cone shapes that are rotated to the curing unit.

[0037] Preferably, in the method described above, the rotational speed of the shaft in the unit forming the groove array is adjusted to completely solidify the liquid cone-shaped array.

[0038] Preferably, in any of the above methods, the injection amount of the injection material is 105-110% of the volume of a single groove in the groove array.

[0039] Preferably, in any of the above methods, the method further includes a step of curing the array of liquid cones using a heating device, wherein the heating device is disposed on one side of the microneedle patch substrate and is respectively opposite to the electric lifting unit and the curing unit.

[0040] Preferably, for any of the methods described above, the method further includes a step of surface treatment of the formed groove array.

[0041] Preferably, in any of the above methods, the method further includes the step of cutting the cured microneedle array to obtain a microneedle patch.

[0042] Preferably, in any of the above methods, the method further includes supporting the substrate for forming the microneedle patch to allow the substrate to rotate continuously to obtain the microneedle patch.

[0043] The effects of the invention

[0044] The system and method described in this invention can rapidly and continuously prepare microneedle patches, enabling batch production, and are simple to operate.

[0045] The system and method described in this invention can prepare microneedle patches with a larger area, comparable in size to commonly used medical dressings or gel patches, and can serve as an effective alternative to these treatment options. It is particularly significant for treating large-area skin nerve pain caused by diseases such as large skin wounds, burns, and shingles.

[0046] The system and method described in this invention can be used to prepare soluble and biodegradable microneedle patches. Attached Figure Description

[0047] Figure 1 This is a schematic diagram of a specific embodiment of the present invention for preparing microneedle patches.

[0048] Figure 2 This is a magnified view of a portion supporting the rotating shaft.

[0049] Figure 3 This is a schematic diagram of the cutting unit, where 1-a unit forming a groove array, 2-a boss array, 3 and 4-a pair of rotating shafts in the unit forming the groove array, 5-groove array, 6-a unit for injecting raw material, 7-raw material, 8-a supporting rotating shaft, 9-substrate, 10-raw material rotating shaft, 11-a surface treatment unit, 12-electric lifting unit, 13-curing and molding unit, 14-an electrode needle array in the electric lifting unit, 15-a first detection device, 16-a first high-pressure device, 17-a rotating shaft in the electric lifting unit, 18-an electrode needle array in the curing and molding unit, 19-a second detection device, 20-a second high-pressure device, 21-a rotating shaft in the curing and molding unit, 22-a heating device, 23-a cutting unit, 24-a microneedle patch, and 25-an end rotating shaft. Detailed Implementation

[0050] The present invention will now be described in detail with reference to the described embodiments. While specific embodiments of the present invention have been shown, it should be understood that the present invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0051] It should be noted that certain terms are used in the specification and claims to refer to specific components. Those skilled in the art will understand that different terms may be used to refer to the same component. This specification and claims do not distinguish components based on differences in terminology, but rather on differences in function. The terms "comprising" or "including" used throughout the specification and claims are open-ended and should be interpreted as "comprising but not limited to." The following descriptions are preferred embodiments of the present invention; however, these descriptions are intended to illustrate the general principles of the specification and are not intended to limit the scope of the present invention. The scope of protection of this invention shall be determined by the appended claims.

[0052] This invention provides a system for preparing microneedle patches, which comprises, in sequence:

[0053] A unit for forming a groove array, used to form a groove array on a microneedle patch substrate;

[0054] A unit for injecting raw materials, used for injecting raw materials into a groove array; and

[0055] An electro-lifting unit is used to electro-lift an array of grooves containing raw materials to form microneedle patches.

[0056] Microneedle patches are a novel type of transdermal drug delivery device. They resemble a band-aid, with their surface covered in grooves filled with medication and tiny needles. Simply place the patch on the skin, and these tiny needles penetrate the outermost layer of the skin, the stratum corneum, delivering the medication to the subcutaneous cells. Because the stratum corneum lacks pain receptors, the microneedles cause virtually no pain during penetration.

[0057] In this invention, no restrictions are placed on the substrate of the microneedle patch. Those skilled in the art can make conventional selections as needed. For example, the substrate of the microneedle patch can be various thermoplastic film materials such as PET film, PE film, PMMA film, and thermoplastic TPU.

[0058] In this invention, no limitation is made on the thickness of the substrate. Those skilled in the art can make conventional selections as needed. For example, the thickness of the substrate can be 500-1000μm.

[0059] For example, the thickness of the substrate can be 500μm, 550μm, 600μm, 650μm, 700μm, 750μm, 800μm, 850μm, 900μm, 950μm, 1000μm, etc.

[0060] In this invention, no restrictions are placed on the size of the bottom of a single groove in the groove array or on the depth of the groove. Those skilled in the art can make conventional selections as needed, as long as the depth is not too large relative to the thickness of the substrate to avoid deformation of the substrate during hot pressing. For example, the shape of the bottom of a single groove can be a rectangle with a side length of 0.5mm–2mm, a circle with a diameter of 0.5mm–2mm, or other shapes within this size range, and the groove depth can be 0.1mm–0.5mm.

[0061] In this invention, no restrictions are placed on the raw materials, as long as they are liquid. For example, an exemplary raw material could be poly(lactic-co-glycolic acid) (PLGA) dissolved in dimethyl carbonate and mixed with lidocaine to form a liquid microneedle raw material.

[0062] Electrospinning refers to a microstructure fabrication method that utilizes the deformation or movement of a liquid under a strong electric field. This principle is widely used in fields such as electrospinning. In this invention, the strong electric field generated by the needle tip drives the liquid material directly below it to deform upwards. The combined effect of this electric field and gravity causes the droplet to form a cone shape that is pointed at the top and thicker at the bottom.

[0063] In some embodiments, the unit forming the groove array includes a pair of rotating shafts respectively disposed on both sides of the substrate, one of the rotating shafts having a spaced array of bosses for forming a groove array on the microneedle patch substrate.

[0064] In this application, the array of bosses may be one or more.

[0065] In some embodiments, the array of protrusions spaced apart on one of the rotating shafts has a heating function, and the pair of rotating shafts exert pre-pressure on the substrate. When the rotating shafts rotate, the array of protrusions comes into contact with the substrate, and under the action of heating and pressure, the array of protrusions is pressed into the substrate to form a groove.

[0066] In this invention, no restrictions are placed on the heating temperature and pressure. Those skilled in the art can select appropriate heating temperature and pressure based on actual needs and the properties of the substrate. For example, the heating temperature is usually controlled between the glass transition temperature and melting point of the substrate; the pressure is usually controlled between 10 kPa and 500 kPa to ensure the quality of the groove and to prevent the substrate from being damaged by high temperature melting or excessive pressure.

[0067] Compared with processes such as 3D printing, laser engraving, and photolithography that first prepare a mold, then solidify it in the mold and demold to prepare microneedles, the system provided by this utility model can prepare larger area groove arrays in batches at low cost and quickly.

[0068] In this invention, the pair of rotating shafts move synchronously along the substrate, and one of the rotating shafts is provided with a boss array at intervals to form a groove array on the substrate.

[0069] In this invention, there are no restrictions on the spacing between the two protrusion arrays. Those skilled in the art can make conventional selections as needed, as long as it can be cut when preparing the microneedle patch. In addition, there are no restrictions on the distance between individual protrusions in the protrusion array. For example, the center-to-center distance between two adjacent protrusions is 1 mm or more to ensure that the needle tips do not interfere with each other.

[0070] In some embodiments, the boss array is located in the middle of the width direction of the pivot shaft to ensure that the formed groove array is located in the middle of the substrate in the width direction of the substrate.

[0071] In this invention, the number of bosses in the boss array is not limited. Those skilled in the art can set it as needed. For example, the boss array can be a square array of 20×20, 40×40, 50×50 or a rectangular array of 50×200 formed in the length and width directions of the rotating shaft.

[0072] In some embodiments, the electric lifting unit includes a first detection device, a first high-voltage device, and a first rotating device with an array of electrode needles;

[0073] The first rotating device is used to fully align the electrode needle array with the groove array containing raw material that has been rotated to the electric lifting unit;

[0074] The first high-pressure device is used to form the raw material in the groove array into a liquid cone shape;

[0075] The first detection device is used to detect whether the electrode needle array is completely aligned with the groove array containing raw material that is rotated to the electric lifting unit.

[0076] In this application, the electrode needle array may be one or more.

[0077] In this invention, no restrictions are placed on the first detection device, as long as it can detect whether the electrode needle array and the groove array containing the raw material rotated to the electric lifting unit are completely aligned. For example, the first detection device can be a camera, a laser alignment instrument, or a photoelectric sensor. For example, a laser source and a photoelectric sensor can be placed on the electrode needle array side and the groove array side respectively, and the photoelectric sensor can be used to determine whether the two are completely aligned by receiving light intensity.

[0078] In this invention, no restrictions are placed on the first high-pressure device; it is only required to enable the raw material in the groove array to form a liquid cone shape. For example, the first high-pressure device can be a high-pressure module. In this invention, no restrictions are placed on the temperature of the first high-pressure device. Those skilled in the art can set the temperature of the first high-pressure device according to the material of the substrate and the raw material to ensure the liquid cone shape of the raw material and to ensure that the substrate as a whole does not undergo significant plastic deformation.

[0079] Under the action of the first high-pressure device, the raw material in the groove array will deform upward, forming a liquid cone that is smaller at the top and larger at the bottom.

[0080] In this invention, the first rotating device with an electrode array has an electrode needle array on it, which is used to completely align the groove array containing raw material with the electrode needle array when the groove array containing raw material rotates to the electric lifting unit.

[0081] The first rotating device includes a pair of rotating shafts and a belt. An array of electrode needles is arranged on the belt. The rotating shafts drive the belt to rotate so as to align the groove array containing raw material with the electrode needle array.

[0082] The electrode needle array is positioned on the belt in the same way as the boss array is positioned on the rotating shaft.

[0083] In this invention, the height of a single electrode needle in the electrode needle array is not limited. Those skilled in the art can make conventional selections as needed. The height should ensure that the part that adsorbs the droplet is concentrated at the needle tip. For example, the height of a single electrode needle can be 1cm–5cm. Similarly, the distance between the tip of a single electrode needle and the surface of the substrate is not limited. Those skilled in the art can make conventional selections as needed. For example, the distance between the tip of the electrode needle and the surface of the substrate can be set to 0.5–1.5mm.

[0084] In this invention, the electro-lifting unit includes several first high-voltage devices, which correspond to the electrode needle array to form the raw material in the groove array into a liquid cone shape. Each first high-voltage device can independently control the voltage applied to each microneedle array.

[0085] This invention employs an electric lifting unit, uses a first detection device to fully align the groove array with the electrode needle array in the first rotating device, and uses a first high-pressure device for curing, which can form the raw material in the groove array into a liquid cone shape.

[0086] In some embodiments, the system further includes a curing unit for curing an array of electrically pulled liquid cones to form microneedle patches.

[0087] In this invention, the curing and molding unit is used to further cure the array of liquid cone shapes after electrolifting to form microneedle patches.

[0088] In some embodiments, the curing and molding unit includes a second detection device, a second high-pressure device, and a second rotating device equipped with an array of electrode needles;

[0089] The second rotating device is used to fully align the electrode needle array with the liquid cone-shaped array that has been rotated to the curing unit;

[0090] The second high-voltage device is used to maintain the shape of the liquid cone; the second high-voltage device can independently control the magnitude of the voltage applied to each microneedle array.

[0091] The second detection device is used to detect whether the electrode needle array is completely aligned with the array of liquid cone shapes that rotate to the curing unit.

[0092] The electrode needle array can be one or more.

[0093] In this invention, the second rotating device, the second high-pressure device, and the second detection device are the same as the first rotating device, the first high-pressure device, and the first detection device in the electric lifting unit.

[0094] In this invention, the distance between the tip of a single electrode needle in the electrode needle array of the second rotating device and the substrate can also be conventionally selected by those skilled in the art as needed. For example, the distance between the tip of a single electrode needle in the electrode needle array and the substrate can be set to 1 cm so that the liquid cone-shaped array can be further solidified and formed.

[0095] In this invention, the use of a curing unit can improve the quality of the liquid cone-shaped array and ensure that the liquid cone shape does not shrink back.

[0096] In some embodiments, the system further includes a heating device for curing the array of liquid cones, preferably the heating device being located on one side of the microneedle patch substrate and opposite the electro-lifting unit and the curing unit, respectively.

[0097] In this invention, the heating device is used to heat the raw material in the groove array to increase the viscosity of the raw material in the groove array and form a liquid cone shape.

[0098] In this invention, the heating temperature of the heating device can be conventionally selected by those skilled in the art as needed. For example, in the electric lifting unit, the heating device is used to heat the substrate to 35-40°C to solidify the raw material and form a liquid cone shape; in the curing and molding unit, the heating device is used to heat the substrate to 45°C to further solidify and mold it.

[0099] In this invention, the rotational speed of the rotating shaft in the groove array unit is adjusted so that the raw material in the groove array is completely solidified.

[0100] In some embodiments, the system further includes a cutting unit for cutting the cured microneedle array into microneedle patches.

[0101] This invention does not impose any restrictions on the cutting unit. Those skilled in the art can choose conventional devices for cutting as needed. For example, the cutting unit includes laser cutting to obtain microneedle patches.

[0102] In some embodiments, the system further includes a surface treatment unit for surface treatment of the formed array of grooves.

[0103] In this invention, the surface treatment unit performs surface treatment on the groove array, which can clean the groove array and improve the hydrophilicity of the groove array surface.

[0104] In some embodiments, the system further includes several supporting rotation axes for supporting the substrate forming the microneedle patch.

[0105] The supporting rotation shaft is used to support the substrate so that the substrate can rotate and ultimately form a microneedle patch.

[0106] Figure 1 This is a schematic diagram of a system for preparing microneedle patches according to a specific embodiment of the present invention, which sequentially includes a unit 1 for forming a groove array, which is used to form a groove array 5 on a microneedle patch substrate;

[0107] Unit 6 for injecting raw material, which is used to inject raw material 7 into the groove array; and

[0108] Electro-lifting unit 12 is used to electro-lift an array of grooves (not shown) containing raw materials to form microneedle patches (not shown).

[0109] The unit 1 that forms the groove array includes a pair of rotating shafts 3 and 4, which are respectively disposed on both sides of the substrate 9. One of the rotating shafts 3 is provided with a boss array 2 at intervals to form a groove array 5 on the microneedle patch substrate.

[0110] The injection unit 6 injects raw material 7 into the groove array 5 to obtain a groove array containing raw material.

[0111] The electric lifting unit 12 includes a first detection device 15, a first high-pressure device 16, and a first rotating device (not shown in the figure) with an electrode needle array 14. The first rotating device is used to make the electrode needle array 14 completely aligned with the groove array containing raw material that has been rotated to the electric lifting unit.

[0112] The first high-pressure device 16 is used to form the raw material in the groove array into a liquid cone shape;

[0113] The first detection device 15 is used to detect whether the electrode needle array 14 is completely aligned with the groove array containing raw material that is rotated to the electric lifting unit. The first detection device 15 may be, for example, a camera.

[0114] The first rotating device includes a pair of rotating shafts 17 and a belt (not shown in the figure). An electrode needle array 14 is provided on the belt. The pair of rotating shafts 17 rotate to drive the belt to rotate, thereby driving the electrode needle array 14 to rotate, so that the electrode needle array 14 is completely aligned with the groove array containing the raw material.

[0115] In some embodiments, the system further includes a curing unit 13 for further curing the electrically pulled liquid cone-shaped array to obtain a microneedle patch. The curing unit 13 includes a second detection device 19, a second high-voltage device 20, and a second rotating device with an electrode needle array 18.

[0116] The second rotating device is used to fully align the electrode needle array 18 with the liquid cone-shaped array that has been rotated to the curing unit;

[0117] The second high-pressure device 20 is used to maintain the shape of the liquid cone;

[0118] The second detection device 19 is used to detect whether the electrode needle array 18 is completely aligned with the liquid cone-shaped array rotated to the curing unit. The second detection device 19 can be, for example, a camera.

[0119] The second rotating device includes a pair of rotating shafts 21 and a belt, on which an array of electrode needles 18 is disposed. The rotating shafts 21 rotate to drive the belt to move, thereby driving the array of electrode needles 18 on the belt to be fully aligned with the array of liquid cones.

[0120] The system also includes a heating device 22 for curing a cone-shaped array of liquid. For example, the heating device 22 is disposed on one side of the microneedle patch substrate 9 and is opposite to the electric lifting unit 12 or the electric lifting unit 12 and the curing unit 13, respectively.

[0121] The system also includes a surface treatment unit 11 for surface treatment of the formed groove array 5 to clean the groove array 5 and improve the hydrophilicity of the groove array 5.

[0122] The system also includes several supporting rotating shafts 8 for supporting the substrate 9, thereby transporting the substrate 9 to the unit 1 forming the groove array, the injection material 6, the electric lifting unit 12 or the electric lifting unit 12 and the curing unit 13 to form microneedle slices; in addition, the system also includes a material rotating shaft 10 wound with the substrate 9 for providing the substrate 9.

[0123] Figure 2 This is an enlarged structural schematic diagram of the structure supporting the rotating shaft 8.

[0124] like Figure 3 As shown, the system also includes a cutting unit 23 for cutting the microneedle patch 24 off the substrate. In this invention, the cutting unit 23 may be a laser cutter, for example. The system may also include an end shaft 25 for collecting unused substrate 9.

[0125] The system described in this invention can rapidly and extensively prepare microneedle patches, and because the substrate can be infinitely extended, it can prepare a large number of microneedle patches.

[0126] This invention provides a method for preparing microneedle patches, which includes the following steps:

[0127] A groove array is formed on a microneedle patch substrate using units that form a groove array;

[0128] The material is injected into the groove array using the injection material unit; and

[0129] An electro-lifting unit is used to electro-lift a groove array containing raw material to form a microneedle patch. In some embodiments, the unit for forming the groove array includes a pair of rotating shafts, respectively disposed on both sides of a substrate, with one shaft having a spaced array of bosses to form the groove array on the microneedle patch substrate. In some embodiments, the electro-lifting unit includes a first detection device, a first high-voltage device, and a first rotating device with an array of electrode needles.

[0130] The first rotating device is used to fully align the electrode needle array with the groove array containing raw material that has been rotated to the electric lifting unit;

[0131] The first high-pressure device is used to shape the raw material in the groove array into a liquid cone shape;

[0132] The method uses a first detection device to detect whether the electrode needle array is completely aligned with the groove array containing raw material rotated to the electro-lifting unit. In some embodiments, the method further includes using a curing unit to cure the electro-lifted liquid cone-shaped array to form a microneedle patch. In some embodiments, the curing unit includes a second detection device, a second high-pressure device, and a second rotating device with the electrode needle array.

[0133] The second rotating device is used to fully align the electrode needle array with the liquid cone-shaped array that has been rotated to the curing unit;

[0134] A second high-pressure device is used to maintain the shape of the liquid cone;

[0135] A second detection device is used to detect whether the electrode needle array is completely aligned with the liquid cone-shaped array rotated to the curing unit. In some embodiments, the rotational speed of the shaft in the unit forming the groove array is adjusted to ensure complete curing of the liquid cone-shaped array. In some embodiments, the injection amount of the injected material is 105%-110% of the volume of a single groove in the groove array to compensate for the reduction of liquid in the grooves after lifting. In some embodiments, the method further includes a step of curing the liquid cone-shaped array using a heating device, preferably the heating device being disposed on one side of the microneedle patch substrate and opposite to the electric lifting unit and the curing unit, respectively. In some embodiments, the method further includes a step of surface treatment of the formed groove array. In some embodiments, the method further includes a step of cutting the cured microneedle array to obtain microneedle patches. In some embodiments, the method further includes supporting the substrate forming the microneedle patch to continuously rotate the substrate to obtain the microneedle patch.

[0136] The method described in this invention uses roll-to-roll and electro-lifting to quickly and in batches prepare microneedle patches. Since the substrate is wound on the raw material shaft, as long as there is enough substrate wound on the raw material shaft, microneedle patches can be prepared indefinitely. The method is simple to operate.

[0137] The system and method described in this invention employ a two-stage lifting technique, which avoids the drawbacks of excessively thick and short microneedles after single-stage lifting and solidification. The resulting microneedles have longer tips and thinner bases, making them easier to penetrate the skin.

[0138] Existing soluble transdermal drug delivery microneedle patches are typically only 1–2 cm in size, while the system and method described in this invention can prepare much larger microneedle patches, such as those with a width of 5 cm and a length exceeding 10 cm. These large-area microneedle patches are significantly larger than currently reported drug-loaded microneedle patches (approximately 1–2 cm on each side) and are comparable in size to commonly used medical dressings or gel patches, making them an effective alternative to these treatment options. This is particularly significant for treating extensive skin wounds, burns, and large-area cutaneous nerve pain caused by diseases such as shingles.

[0139] Compared to the mold method (which uses the most common method of preparing a mold, filling with liquid, curing and demolding, if the microneedle length-to-thinness ratio is too large and the curing area is too large, the microneedle may fail to demold, and a broken part may remain in the mold, resulting in a low success rate of microneedle molding and the mold cannot be reused), the system and method described in this utility model have a higher microneedle molding rate.

[0140] Example

[0141] This utility model provides a general and / or specific description of the materials and test methods used in the experiments. In the following examples, unless otherwise specified, % represents wt%, i.e., weight percentage. Reagents or instruments used without a specified manufacturer are all commercially available conventional reagent products.

[0142] Example 1 uses a system without a curing unit to fabricate microneedle patches.

[0143] use Figure 1 and Figure 3 The exemplary system is prepared as follows:

[0144] The system sequentially includes a raw material rotating shaft 10 containing a substrate 9, a unit 1 forming a groove array, a surface treatment unit 11, a raw material injection unit 6, an electric lifting unit 12, and a cutting unit 23.

[0145] The substrate 9 is a PE film with a thickness of 500μm and a width of 10cm;

[0146] The unit 1 forming the groove array includes a pair of rotating shafts 3 and 4, which are respectively disposed on both sides of the substrate 9. One of the rotating shafts 3 is provided with a boss array 2 at intervals to form a groove array 5 on the microneedle patch substrate 9. The boss array 2 is a 20×20 array in the length and width directions of the substrate. The bottom dimension of a single boss in the boss array 2 is 0.5mm×0.5mm, the height is 0.2mm, and the distance between two adjacent bosses is 1mm.

[0147] The surface treatment unit 11 cleans the surface of the formed groove array 5 and can improve the hydrophilicity of the groove array 5.

[0148] The raw material is obtained by dissolving poly(lactic-co-glycolic acid) (50:50) in dimethyl carbonate and mixing it with the desired drug; the loading amount of the raw material is 105% of the groove volume.

[0149] The electro-lifting unit 12 is used to electro-lift a groove array (not shown in the figure) containing raw materials to form a microneedle patch (not shown in the figure). The electro-lifting unit 12 includes a first detection device 15, a first high-voltage device 16, and a first rotating device (not shown in the figure) with an electrode needle array 14. The first rotating device is used to make the electrode needle array 14 completely aligned with the groove array containing raw materials that has been rotated to the electro-lifting unit 12. The rotating device includes a pair of rotating shafts 17 and a belt (not shown in the figure). The electrode needle array 14 is disposed on the belt. The pair of rotating shafts 17 rotate to drive the belt to rotate, thereby driving the electrode needle array 14 to rotate, so as to make it completely aligned with the groove array containing raw materials.

[0150] The first high-pressure device 16 is used to form the raw material in the groove array into a liquid cone shape;

[0151] The first detection device 15 is used to detect whether the electrode needle array 14 is completely aligned with the groove array containing raw material that is rotated to the electric lifting unit. The first detection device 15 may be, for example, a camera.

[0152] A heating device 22 is provided on the side opposite to the electric lifting unit 12. The heating device 22 is used to solidify the array of liquid cones.

[0153] The cutting unit 23 is used to cut the formed microneedle patch, and the end shaft 25 is used to collect unused microneedle patch substrate 9.

[0154] The system also includes several support shafts 8 for supporting the substrate 9, thereby transporting the substrate 9 to the unit 1 forming the groove array, the injection material 6, and the electro-lifting unit 12 to form microneedle slices;

[0155] The rotational speeds of the shafts 3 and 4 in the unit 1 that forms the groove array are set so that the liquid cone-shaped array moving into the electric lifting 12 is solidified to obtain the microneedle patch.

[0156] The specific steps are as follows:

[0157] The raw material shaft 10 containing the substrate 9 rotates. When it reaches the unit 1 that forms the groove array, the boss array in the unit 1 forms the groove array 5 on the substrate. After being treated by the surface treatment 11, the raw material 7 is injected into the groove array 5 by the raw material injection unit 6 to form a groove array containing the raw material. When the groove array containing the raw material reaches the electric lifting unit 12, the electrode needle array in the electric lifting point 12 is completely aligned with the groove array containing the raw material. The first high-pressure device 16 and the heating device 22 are used to electrically lift the raw material, so that the raw material forms a liquid cone shape to obtain a microneedle patch. Then, the cutting unit 23 is used to cut the microneedle patch on the substrate to obtain a microneedle patch.

[0158] The resulting microneedle patches have advantages such as larger size, for example, up to 5cm*10cm or larger, and higher microneedle formation rate.

[0159] Example 2 uses a system containing a curing unit to prepare microneedle patches

[0160] The difference between Example 2 and Example 1 is that the system further includes a curing and molding unit 13, which is used to further cure and mold the electrically pulled liquid cone-shaped array to obtain a microneedle patch. The curing and molding unit 13 includes a second detection device 19, a second high-voltage device 20, and a second rotating device with an electrode needle array 18.

[0161] The second rotating device is used to make the electrode needle array 18 completely aligned with the liquid cone-shaped array that rotates to the curing unit. The second rotating device includes a pair of rotating shafts 21 and a belt. The electrode needle array 18 is disposed on the belt. The rotating shafts 21 drive the belt to move, thereby driving the electrode needle array 18 on the belt to be completely aligned with the liquid cone-shaped array.

[0162] The second high-pressure device 20 is used to maintain the shape of the liquid cone;

[0163] The second detection device 19 is used to detect whether the electrode needle array 18 is completely aligned with the array of liquid cone shapes that are rotated to the curing unit. The second detection device may be, for example, a camera.

[0164] The rotational speeds of the shafts 3 and 4 in the unit 2 forming the groove array are set so that the array of liquid cones moving into the curing unit 13 is completely cured to obtain a microneedle patch.

[0165] The specific operation method is the same as in Example 1, except that the array of liquid cones that are electro-lifted is further solidified and shaped under the action of the solidification and molding unit 13 to obtain microneedle patches.

[0166] The resulting microneedle patch has a larger aspect ratio, which can be 3-5 times higher than that of microneedles without secondary lifting.

[0167] In addition, the microneedles with secondary lifting have a more uniform thickness change from the tip to the bottom, avoiding the problem of the bottom being too thick and the tip being too small.

[0168] The above description is merely a preferred embodiment of this utility model and is not intended to limit the utility model in any other way. Any person skilled in the art may make changes or modifications to the above-disclosed technical content to create equivalent embodiments. However, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of this utility model without departing from its technical solution shall still fall within the protection scope of this utility model.

Claims

1. A system for preparing microneedle patches, characterized in that, The system comprises, in sequence: A unit for forming a groove array, used to form a groove array on a microneedle patch substrate; A unit for injecting raw materials, used for injecting raw materials into a groove array; and An electro-lifting unit is used to electro-lift an array of grooves containing raw materials to form microneedle patches.

2. The system according to claim 1, characterized in that, The unit for forming the groove array includes a pair of rotating shafts, which are respectively disposed on both sides of the substrate. One of the rotating shafts is provided with a boss array at intervals to form a groove array on the microneedle patch substrate.

3. The system according to claim 1, characterized in that, The electric lifting unit includes a first detection device, a first high-voltage device, and a first rotating device with an array of electrode needles. The first rotating device is used to fully align the electrode needle array with the groove array containing raw material that has been rotated to the electric lifting unit; The first high-pressure device is used to form the raw material in the groove array into a liquid cone shape; The first detection device is used to detect whether the electrode needle array is completely aligned with the groove array containing raw material that is rotated to the electric lifting unit.

4. The system according to claim 3, characterized in that, The system also includes a curing unit for curing and shaping an array of liquid cones after electrolifting to form microneedle patches.

5. The system according to claim 4, characterized in that, The curing and molding unit includes a second detection device, a second high-pressure device, and a second rotating device equipped with an electrode needle array; The second rotating device is used to fully align the electrode needle array with the liquid cone-shaped array that has been rotated to the curing unit; The second high-pressure device is used to maintain the shape of the liquid cone; The second detection device is used to detect whether the electrode needle array is completely aligned with the array of liquid cone shapes that rotate to the curing unit.

6. The system according to claim 3, characterized in that, The system also includes a heating device for curing an array of cone-shaped liquids.

7. The system according to claim 6, characterized in that, The heating device is located on one side of the microneedle patch substrate and is opposite to the electric lifting unit and the curing unit, respectively.

8. The system according to any one of claims 1-7, characterized in that, The system also includes a cutting unit for cutting the cured microneedle array into microneedle patches.

9. The system according to any one of claims 1-7, characterized in that, The system also includes a surface treatment unit for surface treatment of the formed groove array.

10. The system according to any one of claims 1-7, characterized in that, The system also includes several supporting rotation axes for supporting the substrate on which the microneedle patch is formed.

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