Polymer microneedle preparation device and polymer microneedle preparation method

Abstract

The invention provides a polymer microneedle preparation device and a polymer microneedle preparation method. The polymer microneedle preparation device comprises a mold base body and a plurality of silica gel female molds, the silica gel female die is a geometry with a bottom surface, and the outer contour of the silica gel female die shrinks in the direction away from the bottom surface; a plurality of grooves matched with the outer contour shapes of the silica gel female dies are formed in the die base body, the silica gel female dies are contained in the grooves in a one-to-one correspondence mode, and the bottom faces of the silica gel female dies are flush with openings of the grooves; the silica gel female die is provided with a microneedle cavity formed in the bottom face, the microneedle cavity is provided with an opening, and the microneedle cavity shrinks in the direction away from the opening. By means of the configuration, the problems that a silica gel mold is prone to deformation at high temperature, not resistant to high pressure and difficult to be used for hot pressing are solved, and the defect that a metal mold is low in precision is overcome.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a polymer microneedle preparation device and a polymer microneedle preparation method. Background Art

[0002] The existing molds used for polymer microneedle manufacturing usually use pure silicone molds or metal molds. Silicone molds are suitable for preparing soluble microneedles by casting, but cannot be used in polymer melt molding, such as injection molding, hot pressing, etc. The processing cost of metal microneedle negative molds is very high, but the accuracy is difficult to achieve the accuracy of silicone molds. Summary of the invention

[0003] The purpose of the present invention is to provide a polymer microneedle preparation device and a polymer microneedle preparation method to solve the problems existing in the existing polymer microneedle manufacturing mold.

[0004] In order to solve the above technical problems, the present invention provides a polymer microneedle preparation device, which comprises: a mold base and a plurality of silicone female molds;

[0005] The silicone female mold is a geometric body with a bottom surface, and the outer contour of the silicone female mold shrinks in the direction away from the bottom surface; the mold base is provided with a plurality of grooves adapted to the outer contour shape of the silicone female mold, and the plurality of silicone female molds are accommodated in the plurality of grooves in a one-to-one correspondence, and the bottom surface of the silicone female mold is flush with the opening of the groove;

[0006] The silicone female mold has a microneedle cavity opened on the bottom surface, the microneedle cavity has an opening, and the microneedle cavity shrinks in a direction away from the opening.

[0007] Optionally, the polymer microneedle preparation device further comprises a ventilation structure opened in the mold base, wherein the ventilation structure communicates with the groove and the outer surface of the mold base and is used to be connected to the negative pressure end.

[0008] Optionally, the ventilation structure includes a ventilation channel or a porous structure.

[0009] Optionally, the microneedle cavity and the groove are both conical, and the microneedle cavity and the groove are coaxially arranged.

[0010] Optionally, the polymer microneedle preparation device further comprises a laminate, which is used to be stacked on the mold base; the laminate has a plurality of through holes, and the number and arrangement positions of the through holes and the grooves correspond one to one.

[0011] Optionally, the polymer microneedle preparation device further includes a pressing piece, which is used to move toward the microneedle cavity to press the polymer raw material into the microneedle cavity.

[0012] Optionally, the polymer microneedle preparation device further includes a baffle and an overflow channel;

[0013] The enclosure is arranged on the mold base, enclosing all the microneedle cavities to form a receiving cavity adapted to the outer contour shape of the pressing piece; the pressing piece is movably received in the receiving cavity, and the outer peripheral wall of the pressing piece abuts against the inner peripheral wall of the enclosure; the overflow channel is opened on the enclosure.

[0014] Optionally, the cavity wall of the microneedle cavity is parallel to the groove wall of the groove.

[0015] Optionally, the microneedle cavity has a drug loading groove convex mold protruding inwardly on its own cavity wall.

[0016] In order to solve the above technical problems, the present invention also provides a method for preparing a polymer microneedle, which uses the polymer microneedle preparation device as described above; the polymer microneedle preparation method comprises:

[0017] The polymer raw material is placed into the microneedle cavity, and the polymer raw material is molded into a polymer microneedle by using a hot pressing method and / or a casting method.

[0018] Optionally, the hot pressing method comprises:

[0019] Heating the polymer raw material to melt the polymer raw material;

[0020] Pressing the molten polymer raw material into the microneedle cavity;

[0021] The polymer raw material in the microneedle cavity is cooled and molded into the polymer microneedle or a part of the polymer microneedle.

[0022] Optionally, the casting method includes:

[0023] spraying the polymer raw material into the microneedle cavity;

[0024] configuring the interior of the groove to have a negative pressure relative to the microneedle cavity;

[0025] The polymer raw material in the microneedle cavity is dried and molded into the polymer microneedle or a part of the polymer microneedle.

[0026] In summary, in the polymer microneedle preparation device and polymer microneedle preparation method provided by the present invention, the polymer microneedle preparation device includes a mold base and a plurality of silicone female molds; the silicone female mold is a geometric body with a bottom surface, and the outer contour of the silicone female mold shrinks in the direction away from the bottom surface; the mold base is provided with a plurality of grooves adapted to the outer contour shape of the silicone female mold, and the plurality of silicone female molds are accommodated in the plurality of grooves one by one, and the bottom surface of the silicone female mold is flush with the opening of the groove; the silicone female mold has a microneedle cavity opened on the bottom surface, the microneedle cavity has an opening, and the microneedle cavity shrinks in the direction away from the opening.

[0027] With this configuration, since multiple silicone female molds are set in the grooves of the mold base, and the microneedle cavity is opened on the silicone female mold, the difficulty of silicone molds being easily deformed at high temperatures, not resistant to high pressure, and difficult to use for hot pressing is overcome, and the defect of low precision of metal molds is overcome. It can have the precision of silicone molds and can be used in polymer molding methods such as hot pressing and injection molding. It is particularly suitable for preparing composite microneedles with high-precision casting needle tips and hot pressing bases.

[0028] Furthermore, since the outer contour of the silicone female mold shrinks away from the bottom surface to form a pointed tip, the distance between the microneedle cavity and the outer contour of the silicone female mold can be shortened, which is beneficial to improving the air permeability inside the microneedle cavity and improving the molding accuracy of the polymer microneedles.

[0029] In addition, since the multiple silicone negative molds are independently set in different grooves, by customizing different silicone negative molds, polymer microneedles of different shapes, heights, and densities can be customized on a microneedle sheet. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0031] Figure 1 It is a schematic diagram of a polymer microneedle manufacturing mold according to the present invention;

[0032] Figure 2 is a cross-sectional schematic diagram of a polymer microneedle preparation device according to an embodiment of the present invention, which does not include a pressing part and a surrounding block;

[0033] Figure 3 is a partial enlarged schematic diagram of a silicone female mold in an embodiment of the present invention accommodated in a groove;

[0034] Figure 4 is a three-dimensional schematic diagram of a polymer microneedle preparation device according to an embodiment of the present invention, which does not include a pressing part and a surrounding block;

[0035] Figure 5 Schematic diagram of a silicone female mold according to an embodiment of the present invention;

[0036] Figure 6 Schematic diagram of preparing a silicone female mold according to an embodiment of the present invention;

[0037] Figure 7 is a schematic diagram of a lamination according to an embodiment of the present invention;

[0038] Figure 8 is a cross-sectional schematic diagram of a polymer microneedle preparation device according to an embodiment of the present invention, which includes a pressing part and a surrounding block;

[0039] Fig. 9 is a three-dimensional schematic diagram of a polymer microneedle preparation device according to an embodiment of the present invention, which includes a pressing part and a surrounding block;

[0040] Fig.10 is a schematic diagram of a first preferred example of a microneedle product according to an embodiment of the present invention;

[0041] Fig.11 is a schematic diagram of a second preferred example of a microneedle product according to an embodiment of the present invention;

[0042] Fig.12 yes Fig.11 A schematic diagram of a microneedle sheet of a microneedle product shown;

[0043] Fig.13 Schematic diagram of a third preferred example of the microneedle product according to an embodiment of the present invention.

[0044] In the attached figure:

[0045] 01-silicone upper mold; 011-cavity; 02-metal lower mold; 03-upper template; 031-metal microneedle positive mold; 04-lower template; 041-silicone mold cavity; 10-mold base; 11-groove; 20-silicone female mold; 21-bottom surface; 22-microneedle cavity; 30-ventilation structure; 40-laminate; 41-through hole; 50-pressed part; 60-enclosure; 61-overflow channel; 70-polymer microneedle; 71-polymer microneedle ring; 72-inner core; 73-microneedle sheet; 74-rectangular functional module; 75-drug loading tank. DETAILED DESCRIPTION

[0046] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0047] As used in the present invention, the singular forms "one", "an", "one" and "the" include plural objects, the term "or" is usually used to include the meaning of "and / or", the term "several" is usually used to include the meaning of "at least one", and the term "at least two" is usually used to include the meaning of "two or more". In addition, the terms "first", "second" and "third" are used only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which include not only endpoints. In addition, as used in the present invention, "installed", "connected", "connected", and one element "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or one side of another element, unless the content clearly indicates otherwise. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used relative to the exemplary embodiments as shown in the figures, with the upward or upper direction toward the top of the corresponding figure, and the downward or lower direction toward the bottom of the corresponding figure.

[0048] The purpose of the present invention is to provide a polymer microneedle preparation device and a polymer microneedle preparation method to solve the problems existing in the existing polymer microneedle manufacturing mold.

[0049] Please refer to Figure 1 , which shows a polymer microneedle manufacturing mold, which includes a silicone upper mold 01 with multiple cavities 011, and a metal lower mold 02. The metal lower mold 02 can provide support for the silicone upper mold 01, thereby allowing the entire polymer microneedle manufacturing mold to be used for preparing polymer microneedles by hot pressing. Since the cavity 011 is located on the silicone upper mold 01, the tip of the polymer microneedle prepared using it can reach 10μm to 20μm, which is higher than the tip of the polymer microneedle prepared by the metal mold.

[0050] However, research has found that the thinner the thickness of silicone, the better the breathability. Figure 1In the polymer microneedle manufacturing mold shown, the farther the cavity 011 is from the bottom surface of the silicone upper mold 01, the thicker the silicone outside the cavity 011 is, and the worse the air permeability is. Figure 1 The polymer microneedle manufacturing mold shown cannot achieve uniform air permeability, resulting in the polymer microneedles prepared using the mold possibly containing defects such as bubbles, thereby reducing the preparation accuracy of the polymer microneedles.

[0051] To resolve this issue, refer to Figures 2 to 5 An embodiment of the present invention provides a polymer microneedle preparation device, which includes: a mold base 10 and a plurality of silicone female molds 20; the silicone female mold 20 is a geometric body with a bottom surface 21, and the outer contour of the silicone female mold 20 shrinks in a direction away from the bottom surface 21; the mold base 10 is provided with a plurality of grooves 11 adapted to the outer contour shape of the silicone female mold 20, and the plurality of silicone female molds 20 are accommodated in the plurality of grooves 11 in a one-to-one correspondence, and the bottom surface 21 of the silicone female mold 20 is flush with the opening of the groove 11; the silicone female mold 20 has a microneedle cavity 22 opened on the bottom surface 21, the microneedle cavity 22 has an opening, and the microneedle cavity 22 shrinks in a direction away from the opening.

[0052] The bottom surface 21 is preferably a plane, but the present embodiment does not limit the bottom surface 21 to be a plane, and it may also be a curved surface. A plurality of grooves 11 are preferably provided on a surface of the mold base 10, and the surface is preferably a plane, but the present embodiment does not limit the surface to be a plane, and it may also be a curved surface. The outer contour of the silicone female mold 20 may shrink linearly or nonlinearly in the direction away from the bottom surface 21. For example, the shrinkage of the outer contour of the silicone female mold 20 may also be in an arc shape. The outer contour of the silicone female mold 20 may shrink in the direction away from the bottom surface 21 in its entirety, or only a portion of the outer contour of the silicone female mold 20 may shrink in the direction away from the bottom surface 21. Those skilled in the art may make their own choices based on actual conditions, and the present embodiment does not impose any restrictions on this.

[0053] With such configuration, since a plurality of silicone female molds 20 are arranged in the groove 11 of the mold base 10, and the microneedle cavity 22 is opened on the silicone female mold 20, the difficulty of silicone molds being easily deformed at high temperatures, not resistant to high pressure, and difficult to use for hot pressing is overcome, and the defect of low precision of metal molds is overcome, and it can have both the precision of silicone molds and can be applied to polymer molding methods such as hot pressing and injection molding. It is particularly suitable for preparing composite microneedles of high-precision casting needle tips and hot pressing bases. Furthermore, since the outer contour of the silicone female mold 20 shrinks in the direction away from the bottom surface 21, the distance between the microneedle cavity 22 and the outer contour of the silicone female mold 20 can be shortened, which is conducive to improving the air permeability effect inside the microneedle cavity 22 and improving the molding precision of polymer microneedles.

[0054] It should be noted that in some embodiments, the multiple silicone female molds 20 included in the polymer microneedle preparation device can be the same or different. Since the multiple silicone female molds 20 are independently arranged in different grooves 11, by customizing different silicone female molds 20, that is, by forming different microneedle cavities in the silicone female mold 20 to customize polymer microneedles of different shapes and heights, it is also possible to customize polymer microneedles of different shapes, heights and densities on a microneedle sheet.

[0055] Preferably, the polymer microneedle preparation device also includes a ventilation structure 30 opened in the mold base 10, and the ventilation structure 30 connects the groove 11 and the outer surface of the mold base 10. It can be understood that the provision of the ventilation structure 30 is conducive to further improving the ventilation effect inside the microneedle cavity 22. Preferably, the ventilation structure 30 connects the groove 11 and the outer surface of the mold base 10 opposite to the side where the groove 11 is opened. Further, the ventilation structure 30 is preferably arranged inside the mold base 10. Optionally, the ventilation structure 30 includes a ventilation channel or a porous structure. In one exemplary embodiment, as Figure 2 and Figure 3 As shown, the mold base 10 is a metal base, that is, it is made of metal material, and the ventilation structure 30 includes a ventilation channel, which can be opened through the mold base 10, one end of the ventilation channel is connected to the groove 11, and the other end is opened at the outer surface of the mold base 10. The ventilation channel is preferably a circular hole. Optionally, the part where the ventilation channel is connected to the groove 11 can be, for example, the side wall of the groove 11. In other embodiments, the ventilation structure 30 is not limited to the ventilation channel, and part or all of the mold base 10 can also be composed of a porous structure, so that the ventilation structure 30 is formed by the porous structure. The porous structure can be, for example, a structural foamed polymer, which has a certain strength and does not require additional processing of the ventilation channel, and can also achieve a certain ventilation effect.

[0056] In some embodiments, the ventilation structure 30 can be directly connected to the atmosphere on the outer surface of the mold base 10. In other embodiments, the ventilation structure 30 is connected to the negative pressure end on the outer surface of the mold base 10. The negative pressure end can be, for example, a vacuum pump or other vacuum equipment, or a negative pressure pipeline provided by a production plant, etc., which is not limited in this embodiment. In a preferred example, the pressure of the negative pressure end is -10kPa to -90kPa.

[0057] The study found that when a liquid polymer raw material is placed in the microneedle cavity 22 to prepare a polymer microneedle, a capillary phenomenon will occur under the action of surface tension, causing the top of the liquid surface of the polymer raw material (i.e., the side of the opening of the microneedle cavity 22) to form a concave surface, and as the polymer raw material cools or dries, the concave surface gradually becomes larger, which will cause the molded polymer microneedle needle body to have a larger concave cavity. In the subsequent microneedle product molding process, when the adhesive is difficult to completely fill these concave cavities, the prepared microneedle product will have bubbles, affecting the puncture mechanical properties. On the other hand, when the polymer raw material is placed in the microneedle cavity 22, the polymer raw material may be difficult to fully fill the tip of the microneedle cavity 22, resulting in poor precision in the needle tip shape of the molded microneedle needle body. When the ventilation structure 30 is connected to the negative pressure end, the gas in the microneedle cavity 22 will be extracted through the silicone female mold 20. When the pressure of the polymer raw material in the microneedle cavity 22 formed by the pressure difference is greater than the surface tension of the polymer raw material, the concave surface formed by the surface tension is destroyed and can be more concentrated on the tip of the microneedle cavity 22, thereby improving the shape accuracy of the needle tip of the polymer microneedle and overcoming the defect of forming a concave cavity in the needle body of the polymer microneedle during molding.

[0058] Please refer to Figure 6 , which exemplarily shows a preparation device of a silicone female mold 20, which includes an upper template 03 and a lower template 04, wherein the upper template 03 has a plurality of metal microneedle male molds 031, and the lower template 04 has a plurality of silicone mold cavities 041. After the silicone mold cavity 041 is filled with silicone raw materials, the upper template 03 and the lower template 04 are molded close to each other, and the silicone raw materials can be cured by heating or after a certain period of time to obtain the silicone female mold 20. In some embodiments, the lower template 04 can directly use the mold base 10, and directly use the groove 11 as the silicone mold cavity 041. At this time, after the silicone raw materials are cured, no additional demolding is required, and it can be left in the groove 11 of the mold base 10. In other embodiments, after the silicone raw materials are cured, the silicone female mold 20 can be removed from the silicone mold cavity 041 and placed in the groove 11 of the mold base 10. At this time, the silicone female mold 20 can be selectively arranged and adjusted according to the shape and density actually required by the polymer microneedles.

[0059] Please continue to refer to Figure 3 It can be understood that, when the metal microneedle male mold 031 remains unchanged, the wall thickness dimension d of the silicone female mold 20 can be adjusted by changing the size of the lower silicone mold cavity 041, and the wall thickness dimension d is preferably 0.001mm to 1.000mm. Of course, in other embodiments, the wall thickness dimension d of the silicone female mold 20 can also be adjusted by adjusting the size of the metal microneedle male mold 031 while the silicone mold cavity 041 remains unchanged.

[0060] Preferably, the microneedle cavity 22 and the groove 11 are both conical, and the microneedle cavity 22 and the groove 11 are coaxially arranged. It should be noted that the cone here includes a cone, a pyramid or a quadratic cone such as an elliptical cone. The axis of the cone is the line connecting its vertex and the center of its bottom surface. The coaxial arrangement of the microneedle cavity 22 and the groove 11 means that the axes of the two coincide on the same straight line. Further, the cavity wall of the microneedle cavity 22 is parallel to the groove wall of the groove 11. It should be noted that the cavity wall or groove wall refers to the wall surface connected between the vertex and the bottom surface of the cone. When the cavity wall of the microneedle cavity 22 is parallel to the groove wall of the groove 11, it can be understood that the microneedle cavity 22 can be understood to be similar to the groove 11 at this time. At this time, the distance between the cavity wall of the microneedle cavity 22 and the outer wall of the silicone female mold 20 is kept uniform, which can make the silicone female mold 20 more uniformly permeable and further improve the precision of the prepared polymer microneedle.

[0061] It can be understood that in some embodiments, the groove 11 does not necessarily have to be a cone similar to the microneedle cavity 22, and its tip can also be platform-shaped. For example, when the microneedle cavity 22 is a cone, the groove 11 can be a truncated cone. As long as the groove 11 tends to gradually shrink away from its opening, the effect of improving the air permeability of the silicone female mold 20 can be achieved.

[0062] Optionally, the microneedle cavity 22 has a drug-carrying groove convex mold (not shown) protruding inwardly on its own cavity wall. The preparation of the drug-carrying groove convex mold can be achieved by laser engraving a pit on the metal microneedle positive mold 031. In this case, the microneedle cavity 22 of the silicone female mold 20 made by silicone mold re-molding has a drug-carrying groove convex mold. Furthermore, the polymer microneedle 70 prepared based on the microneedle cavity 22 with the drug-carrying groove convex mold has a drug-carrying groove 75 (please refer to Fig.12 ).

[0063] Optionally, the polymer microneedle preparation device further includes a laminate 40, which is used to be stacked on the mold base 10; the laminate 40 has a plurality of through holes 41, and the number and arrangement position of the through holes 41 and the grooves 11 correspond one to one. Preferably, the through hole 41 is coaxially arranged with the corresponding groove 11. It can be understood that the through hole 41 is also coaxially connected with the microneedle cavity 22 of the silicone female mold 20 set in the groove 11. Optionally, the cross-sectional shape of the through hole 41 can be the same as the opening shape of the microneedle cavity 22, so that the length of the needle body of the prepared polymer microneedle can be increased by setting the laminate 40. Optionally, the cross-sectional shape of the through hole 41 can be different from the opening shape of the microneedle cavity 22, so that by setting the laminate 40, a cavity with a different shape from the microneedle cavity 22 can be formed in the part of the microneedle cavity 22 away from the tip, thereby changing the bottom shape of the prepared polymer microneedle. For example, if the through hole 41 is square and the microneedle cavity 22 is conical, the bottom of the needle body of the finally prepared polymer microneedle is a quadrangular prism and the needle tip is conical.

[0064] Preferably, the thickness of the laminate 40 is 0.01 mm to 1.00 mm. It is understandable that by stacking different laminates 40 on the mold base 10, the needle length of the polymer microneedle or the bottom shape of the polymer microneedle can be changed without developing a new mold. Through the combination of the microneedle cavity 22 and the through hole 41, the segmented design adjustment and preparation of the polymer microneedle is achieved.

[0065] In some application scenarios, if the casting method is used to prepare the polymer microneedle, the polymer microneedle preparation device may only include the mold base 10 and the silicone female mold 20. In other application scenarios, if the hot pressing method is used to prepare the polymer microneedle, the polymer microneedle preparation device preferably also includes a pressing member 50, which is used to move toward the microneedle cavity 22 to press the polymer raw material into the microneedle cavity 22. Optionally, the pressing pressure of the pressing member 50 on the polymer raw material is 0.1MPa to 1.0MPa.

[0066] For further information, please refer to Figure 8 , Fig. 9The polymer microneedle preparation device further includes a baffle 60 and an overflow channel 61; the baffle 60 is arranged on the mold base 10, enclosing all the microneedle cavities 22 to form a receiving cavity adapted to the circumferential outer contour of the pressing piece 50; the pressing piece 50 is movably received in the receiving cavity, and the outer peripheral wall of the pressing piece 50 abuts against the inner peripheral wall of the baffle 60; the overflow channel 61 is opened on the baffle 60. The baffle 60 is used to limit the polymer raw material, and when the pressing pressure of the pressing piece 50 is high, the excess polymer raw material can flow out through the overflow channel 61. In some embodiments, when the stack 40 is provided, the baffle 60 can be indirectly provided on the mold base 10 by being stacked on the stack 40.

[0067] The embodiment of the present invention further provides a method for preparing a polymer microneedle, which uses the polymer microneedle preparation device as described above; the polymer microneedle preparation method comprises:

[0068] The polymer raw material is placed into the microneedle cavity 22, and the polymer raw material is molded into polymer microneedles by hot pressing and / or casting.

[0069] Optionally, the hot pressing method comprises:

[0070] Step SA1: heating the polymer raw material to melt the polymer raw material;

[0071] Step SA2: Pressing the molten polymer raw material into the microneedle cavity 22;

[0072] Step SA3: The polymer raw material in the microneedle cavity 22 is cooled and then molded into the polymer microneedle or a part of the polymer microneedle.

[0073] The polymer raw materials applicable to the hot pressing method are mainly high-viscosity polymers, such as PLA, PP, etc., which can be hot-melted into a liquid with a certain viscosity, so that the pressed piece 50 is pressed into the microneedle cavity 22. Furthermore, when the mold base 10 is a metal base, it can quickly achieve a heat conduction effect and quickly melt the high-viscosity polymer. Optionally, the high-viscosity polymer can be hot-melted under a negative pressure environment of -90kPa. At this time, the negative pressure environment can fully fill the microneedle cavity 22 with the high-viscosity polymer through the ventilation structure 30. In step SA3, after maintaining the pressure of the pressed piece 50 for 5 minutes, the polymer microneedle preparation device can be moved to a cooling table and cooled by water cooling or air cooling.

[0074] Optionally, the casting method includes:

[0075] Step SB1: spraying the polymer raw material into the microneedle cavity 22;

[0076] Step SB2: configuring the groove 11 to have a negative pressure relative to the microneedle cavity 22;

[0077] Step SB3: The polymer raw material in the microneedle cavity 22 is dried and then molded into the polymer microneedle or a part of the polymer microneedle.

[0078] The polymer raw materials applicable to the casting method are mainly low-viscosity polymers, such as polymer solutions. Example formula 1 of polymer solution: PVP (polyvinyl pyrrolidone): PVA (polyvinyl alcohol): API (raw material): HA (sodium hyaluronate): H2O = 2:1:0.1:1:5.9. Example formula 2 of polymer solution: First, PVP, PVA, and CMC (sodium carboxymethyl cellulose) are mixed at a ratio of 2:1:0.5 to prepare a matrix solution, and then the water-soluble API and the matrix solution are mixed at a ratio of 1:99 to prepare a polymer solution.

[0079] The polymer solution can be sprayed into the microneedle cavity 22 by spraying (single or multiple times). Until the polymer solution and the opening of the microneedle cavity 22 are at the same horizontal plane. Then, the groove 11 is configured to be negative pressure, for example, the ventilation structure 30 is connected to the negative pressure end on the outer surface of the mold base 10, and the duration is 30 minutes. The gas in the microneedle cavity 22 will pass through the silicone female mold 20 into the ventilation structure 30 and be extracted. After the duration is reached, the ventilation structure 30 can be closed on the outer surface of the mold base 10, for example, a film material is used to seal and isolate the gas exchange inside and outside the mold base 10, so that the mold base 10 can maintain a local vacuum negative pressure state. The preparation is completed after the polymer solution in the microneedle cavity 22 is dried.

[0080] In some embodiments, hot pressing and casting can be used in combination to prepare polymer microneedles comprising two or more composite sections, i.e., composite microneedles. Different sections of the composite microneedle (such as the needle tip, needle body, microneedle sheet substrate, etc.) can be prepared using different molding steps. In an exemplary embodiment of a composite microneedle, the needle tip and / or needle body are prepared by casting, and the needle body and / or microneedle sheet substrate are prepared by hot pressing. Therefore, the first step can be to prepare the needle tip and / or needle body by casting and drying according to steps SA1 to SA3, and then the second step can be to prepare the needle body and / or microneedle sheet substrate by hot pressing according to steps SB1 to SB3.

[0081] In some application scenarios, silicone female molds 20 of different shapes and sizes can be prepared first. Since each silicone female mold 20 is independently embedded in the groove 11 of the mold base 10, the silicone female molds 20 of different shapes or sizes can be individually transferred to the microneedle sheet substrate using precision equipment. The microneedle sheet substrate is coated with an adhesive, such as UV glue or high-concentration HA. After the polymer microneedles in the silicone female mold 20 are fully in contact with the adhesive on the microneedle sheet substrate and solidified, the silicone female mold 20 can be removed to form a microneedle sheet with polymer microneedles of different heights and shapes.

[0082] Figures 10 to 13 Several exemplary examples of microneedle products are shown, wherein the polymer microneedles contained therein are prepared by the polymer microneedle preparation device provided in this embodiment according to the above-mentioned polymer microneedle preparation method.

[0083] Fig.10 The microneedle product shown comprises a plurality of polymer microneedle circles 71 , each of which comprises a plurality of polymer microneedles 70 arranged circumferentially. Preferably, the polymer microneedles 70 have drug loading grooves 75 .

[0084] Fig.11 The microneedle product shown comprises a cylindrical inner core 72 and a microneedle sheet 73 attached to the outer periphery of the inner core 72. The microneedle sheet 73 is preferably arranged along the axial direction of the inner core 72. The unfolded shape thereof is as follows: Fig.12 As shown, the microneedle sheet 73 has a plurality of polymer microneedles 70 , and preferably, the polymer microneedles 70 have drug loading grooves 75 .

[0085] Fig.13 The microneedle product shown includes a cuboid functional module 74 and a microneedle sheet 73 disposed on the cuboid functional module 74. The cuboid functional module 74 may optionally have a heating resistor wire or a linear motor filled therein to provide vibration action.

[0086] certainly Figures 10 to 13 The microneedle product shown is only an example of the polymer microneedles prepared by the polymer microneedle preparation device provided in this embodiment and is not intended to be limiting. Those skilled in the art may also apply the polymer microneedles prepared by the polymer microneedle preparation device provided in this embodiment to other microneedle products.

[0087] In summary, in the polymer microneedle preparation device and polymer microneedle preparation method provided by the present invention, the polymer microneedle preparation device includes a mold base and a plurality of silicone female molds; the silicone female mold is a geometric body with a bottom surface, and the outer contour of the silicone female mold shrinks in the direction away from the bottom surface; the mold base is provided with a plurality of grooves adapted to the outer contour shape of the silicone female mold, and the plurality of silicone female molds are accommodated in the plurality of grooves one by one, and the bottom surface of the silicone female mold is flush with the opening of the groove; the silicone female mold has a microneedle cavity opened on the bottom surface, the microneedle cavity has an opening, and the microneedle cavity shrinks in the direction away from the opening. In this configuration, since the plurality of silicone female molds are arranged in the grooves of the mold base, and the microneedle cavity is opened on the silicone female mold, the difficulty of silicone molds being easy to deform at high temperature, not resistant to high pressure, and difficult to use for hot pressing is overcome, and the defect of low precision of metal molds is overcome, and it can have both the precision of silicone molds and can be applied in polymer molding methods such as hot pressing and injection molding. It is particularly suitable for preparing composite microneedles composed of high-precision casting needle tips and hot-pressed substrates. Furthermore, since the outer contour of the silicone female mold shrinks away from the bottom surface, the distance between the microneedle cavity and the outer contour of the silicone female mold can be shortened, which is beneficial to improving the air permeability inside the microneedle cavity and improving the molding accuracy of the polymer microneedles. In addition, since multiple silicone female molds are independently arranged in different grooves, by customizing different silicone female molds, polymer microneedles of different shapes, heights, and densities can be customized on a microneedle sheet.

[0088] It should be noted that the above embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the protection scope of the present invention.

Claims

1. A polymer microneedle preparation device, characterized in that: include: A mold base and a plurality of silicone female molds; The silicone female mold is a geometric body having a bottom surface, and the outer contour of the silicone female mold shrinks in a direction away from the bottom surface; The mold base is provided with a plurality of grooves matching the outer contour of the silicone female mold, and the plurality of silicone female molds are accommodated in the plurality of grooves in a one-to-one correspondence, and the bottom surface of the silicone female mold is flush with the opening of the groove; The silicone female mold has a microneedle cavity opened on the bottom surface, the microneedle cavity has an opening, and the microneedle cavity shrinks in a direction away from the opening.

2. The polymer microneedle preparation device according to claim 1, characterized in that: The polymer microneedle preparation device also includes a ventilation structure opened in the mold base, the ventilation structure is connected with the groove and the outer surface of the mold base, and is used to connect with the negative pressure end.

3. The polymer microneedle preparation device according to claim 2, characterized in that: The ventilation structure includes a ventilation channel or a porous structure.

4. The polymer microneedle preparation device according to claim 1, characterized in that: The microneedle cavity and the groove are both conical, and the microneedle cavity and the groove are coaxially arranged.

5. The polymer microneedle preparation device according to claim 1, characterized in that: The polymer microneedle preparation device also includes a laminate, which is used to be stacked on the mold base; the laminate has a plurality of through holes, and the number and arrangement positions of the through holes and the grooves correspond one to one.

6. The polymer microneedle preparation device according to claim 1, characterized in that: The polymer microneedle preparation device also includes a pressing piece, which is used to move toward the microneedle cavity to press the polymer raw material into the microneedle cavity.

7. The polymer microneedle preparation device according to claim 6, characterized in that: The polymer microneedle preparation device also includes a baffle and an overflow channel; The enclosure is arranged on the mold base, enclosing all the microneedle cavities to form a receiving cavity adapted to the circumferential outer contour shape of the pressing piece; the pressing piece is movably received in the receiving cavity, and the outer peripheral wall of the pressing piece abuts against the inner peripheral wall of the enclosure; the overflow channel is opened on the enclosure.

8. The polymer microneedle preparation device according to claim 1, characterized in that: The cavity wall of the microneedle cavity is parallel to the groove wall of the groove.

9. The polymer microneedle preparation device according to claim 1, characterized in that: The microneedle cavity has a drug loading groove convex mold protruding inwardly on its own cavity wall.

10. A method for preparing a polymer microneedle, characterized in that: A polymer microneedle preparation device according to any one of claims 1 to 9; the polymer microneedle preparation method comprises: The polymer raw material is placed into the microneedle cavity, and the polymer raw material is molded into polymer microneedles by hot pressing and / or casting.

11. The method for preparing a polymer microneedle according to claim 10, characterized in that: The hot pressing method comprises: Heating the polymer raw material to melt the polymer raw material; Pressing the molten polymer raw material into the microneedle cavity; The polymer raw material in the microneedle cavity is cooled and molded into the polymer microneedle or a part of the polymer microneedle.

12. The method for preparing polymer microneedles according to claim 10, characterized in that: The pouring method comprises: Spraying the polymer raw material into the microneedle cavity; configuring the interior of the groove to have a negative pressure relative to the microneedle cavity; The polymer raw material in the microneedle cavity is dried and molded into the polymer microneedle or a part of the polymer microneedle.

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