JP5886535B2 - Manufacturing method of microneedle sheet - Google Patents

Description

  The present invention relates to a microneedle sheet for injecting a drug into the epidermis of the skin and a method for producing the same.

  The microneedle sheet is obtained by arranging minute needles (microneedles) at a predetermined density on a sheet substrate. The microneedle is generally formed in a conical shape having a length from the base to the tip of about 1 μm to 600 μm and a diameter of the base of about 0.3 μm to 400 μm. 1): It has a high aspect ratio of (1.5 to 3). The microneedle sheet is used for injecting a drug by placing the microneedle into the epidermis portion of the skin by applying it to the skin portion of the human body.

  The length of the microneedle is about several hundred μm as described above, and can be used with almost no colic. Further, when the microneedle sheet is separated from the skin, the microneedle portion is formed of a self-dissolving substance so that the human body is not affected even if the microneedle remains in the skin.

  Among drugs injected into the human body using such microneedles, expensive drugs are included. Therefore, it has been proposed that the microneedle is formed in a multilayer structure so that the drug is included only in the tip portion of the microneedle and the drug is not included in the portion other than the tip portion (see, for example, Patent Document 1).

  A conventional method for producing a microneedle sheet having such a multi-layered microneedle will be described with reference to FIG.

  First, a stamper 90 in which a plurality of conical recesses 91 are formed is prepared. The stamper 90 is formed by pressing a flat original plate on which protrusions corresponding to the individual microneedles are formed against the stamper base material. In the stamper base material, a plurality of conical recesses corresponding to the plurality of protrusions of the original plate are formed, and these become the stamper 90. Each protrusion of the original plate is formed by a method such as micromachining, vacuum processing, or photolithography. The protrusion has a conical shape or a pyramid shape having a cross-sectional shape such as a circle, a corner, or an ellipse.

  A first needle material 92 containing a drug is filled in each recess 91 of the stamper 90. The first needle raw material 92 is filled in a fixed amount by using, for example, a dispenser at the tip portion in each recess 91 and then dried.

  Next, the second needle raw material 93 not containing a drug is filled in each of the recesses 91 filled with the first needle raw material 92. The second needle raw material 93 is filled on the first needle raw material 92 using, for example, a squeegee 94 and then dried.

  Then, a fixed base is affixed on the stamper 90, and the needle raw materials filled in the respective recesses 91 are fixed to the fixed base. By separating the fixed base from the stamper 90, a microneedle sheet having a two-layer structure including a first layer containing a drug made of the first needle raw material 92 and a second layer made of the second needle raw material 93 is obtained. Complete.

JP 2010-94414 A

  However, the conventional method for manufacturing a microneedle sheet having a microneedle having a multilayer structure has the following problems. The needle material filled in the recess is a first needle that has been previously filled with a shearing force at the time of filling with a drying stress, a squeegee or the like in a series of steps including a drying step, a filling step for the next layer, and a drying step. There is a case where the raw material is detached from the inside of the concave portion (for example, an example of separation by a shearing force at the time of filling is shown in FIG. 10). In the drying process of drying the needle material filled in the recess, if the needle material shrinks in volume, the needle material is not fixed in the recess due to the drying stress, and an external force (shearing force due to squeegee etc.) Etc.) may be added to the needle material from the recess. Furthermore, if the second needle material is filled in a state where the previously filled first needle material is not fixed in the recess, a predetermined needle height may not be obtained. That is, in any case, there is a problem that the predetermined drug amount varies. In addition, such a problem is not limited to a microneedle having a multilayer structure, and the same problem exists in a microneedle having a single layer structure.

  Accordingly, an object of the present invention is to solve the above-described problems, and to provide a method for manufacturing a microneedle sheet and a microneedle sheet that suppress variation in the amount of drug contained in the tip portion of the microneedle.

  In order to achieve the above object, the present invention is configured as follows.

  According to the first aspect of the present invention, there is provided a method for producing a microneedle sheet, wherein a plurality of conical recesses taper from the front surface to the back surface of a sheet-like base material, and the bottoms of the respective recesses A stamper preparation step for preparing a sheet-like stamper having a through-hole penetrating from the back surface to the back surface, a suction step for sucking from the through-hole on the back surface of the base material, and filling the needle material into the respective recesses from the surface of the stamper Provided is a method for producing a microneedle sheet, which includes a filling step and a needle raw material drying step for drying a needle raw material filled in a recess, and performing a suction step at least during the needle raw material drying step.

  According to the second aspect of the present invention, there is provided a method of manufacturing a microneedle sheet, wherein a plurality of conical recesses taper from the front surface to the back surface of the sheet-like base material, and the bottoms of the respective recesses. A stamper preparation step for preparing a sheet-like stamper having a through-hole penetrating from the back surface to the back surface, a suction step for sucking from the through-hole on the back surface of the base material, and filling the needle material into the respective recesses from the surface of the stamper The filling process, the adhesive material arrangement process for arranging the adhesive material on the surface of the stamper, and the fixed base arrangement for attaching the fixed base to the adhesive material and fixing the needle material in each recess to the fixed base via the adhesive material A method for producing a microneedle sheet, wherein the suction step is performed at least during the execution of the adhesive material arranging step.

  According to a third aspect of the present invention, the method according to the second aspect, further comprising an adhesive material drying step for drying the adhesive material after the fixed substrate arranging step, and performing the suction step during the implementation of the adhesive material drying step. A method for producing a microneedle sheet is provided.

  According to the 4th aspect of this invention, the manufacturing method of the microneedle sheet | seat as described in any one of the 1st aspect to the 3rd aspect which implements a suction process during implementation of a filling process is provided.

  According to the fifth aspect of the present invention, there is provided a method for manufacturing a microneedle sheet, wherein a plurality of conical recesses taper from the front surface to the back surface of the sheet-like base material, and the bottoms of the respective recesses A stamper preparation step for preparing a sheet-shaped stamper having a through hole penetrating from the back surface to the back surface, a suction step for sucking from the through hole on the back surface of the base material, and the first needle raw material into each recess from the surface of the stamper And a second filling step for filling the second needle raw material into each of the recesses filled with the first needle raw material, and at least a suction step during the second filling step. A method for producing a microneedle sheet is provided.

  According to the sixth aspect of the present invention, there is provided a method for manufacturing a microneedle sheet, wherein a plurality of conical recesses taper from the front surface to the back surface of a sheet-like base material, and the bottoms of the respective recesses. A stamper preparation step for preparing a sheet-shaped stamper having a through hole penetrating from the back surface to the back surface, a suction step for sucking from the through hole on the back surface of the base material, and the first needle raw material into each recess from the surface of the stamper A first filling step for filling the first needle raw material, a second filling step for filling the second needle raw material into the respective recesses filled with the first needle raw material, and an adhesive material arranging step for arranging the adhesive material on the surface of the stamper And a fixing base arrangement step of attaching a fixing base to the adhesive material and fixing the needle material in each recess to the fixing base via the adhesive material, and at least performing the adhesive material arrangement step Implementing a suction process, to provide a method of manufacturing a microneedle sheet.

  According to a seventh aspect of the present invention, there is provided a method for manufacturing a microneedle sheet, wherein a plurality of conical recesses taper from the front surface to the back surface of a sheet-like base material, and the bottoms of the respective recesses A stamper preparation step for preparing a sheet-shaped stamper having a through hole penetrating from the back surface to the back surface, a suction step for sucking from the through hole on the back surface of the base material, and the first needle raw material into each recess from the surface of the stamper A first filling step for filling the first needle raw material filled in the recess, a first raw material drying step for drying the first needle raw material filled in the concave portion, and a second needle raw material in each concave portion filled with the first needle raw material. A suction step during at least the first raw material drying step or the second raw material drying step, including a second filling step of filling and a second raw material drying step of drying the second needle raw material filled in the recess. The fruit To provide a method for producing a microneedle sheet.

  According to an eighth aspect of the present invention, the method according to the sixth aspect, further comprising an adhesive material drying step of drying the adhesive material after the fixed base plate arranging step, and performing the suction step during the execution of the adhesive material drying step. A method for producing a microneedle sheet is provided.

  According to a ninth aspect of the present invention, there is provided the method for producing a microneedle sheet according to any one of the fifth aspect to the eighth aspect, wherein the suction step is performed during the first filling step.

  According to the tenth aspect of the present invention, in the suction step, by sucking the porous member disposed on the back surface of the stamper, the suction of the concave portion through each through hole is performed via the porous member. A method for producing a microneedle sheet according to any one of the first to ninth aspects is provided.

  According to an eleventh aspect of the present invention, in a microneedle sheet comprising a sheet-like fixing member and a plurality of conical needles fixed to the surface of the fixing member, the needle is disposed at the conical tip. A first needle layer and a second needle layer that forms a part of a cone and is fixed to the first needle layer, the tip diameter of the first needle layer being in the range of 1 to 20 μm And the tip of the first needle layer is formed in a flat shape or a convex shape.

  In the present invention, the back surface of the base material is penetrated at the timing when a process such as a drying stress or a shearing force is applied to the needle raw material filled in the recess formed on the surface of the stamper base material. A suction step of sucking from the hole is performed. Therefore, since the needle material is fixed in the recess by suction through the through hole, it is possible to prevent the needle material from being detached from the recess against a force such as a drying stress or a shearing force. Therefore, a predetermined number of microneedles is secured, and fluctuations in drug amount can be suppressed.

Sectional drawing of the stamper used with the manufacturing method of the microneedle sheet | seat concerning embodiment of this invention Sectional drawing of the base member used with the manufacturing method of this Embodiment The flowchart which shows the procedure of the manufacturing method of this Embodiment Explanatory drawing of the 1st needle raw material filling process in the manufacturing method of this Embodiment Explanatory drawing of the 1st needle raw material drying process in the manufacturing method of this Embodiment Explanatory drawing of the 2nd needle raw material filling process in the manufacturing method of this Embodiment Explanatory drawing of the 2nd needle raw material drying process in the manufacturing method of this Embodiment Explanatory drawing of the adhesive material arrangement | positioning process in the manufacturing method of this Embodiment Explanatory drawing of the fixed base | substrate arrangement | positioning process in the manufacturing method of this Embodiment Explanatory drawing of the microneedle sheet peeling process in the manufacturing method of this Embodiment Sectional drawing of the microneedle manufactured by the manufacturing method of this Embodiment Sectional drawing of the microneedle of another form manufactured by the manufacturing method of this Embodiment Cross-sectional view of comparative example microneedle Sectional drawing of the microneedle of another form manufactured by the manufacturing method of this Embodiment Explanatory drawing of the manufacturing method of the conventional microneedle sheet Explanatory drawing of the manufacturing method of the conventional microneedle sheet

  Embodiments according to the present invention will be described below in detail with reference to the drawings.

  A schematic diagram of a stamper 1 used in the method of manufacturing a microneedle sheet according to an embodiment of the present invention is shown in FIG.

  As shown in FIG. 1, the stamper 1 is a sheet-like base material 2 having a conical recess 3 formed therein. The material of the base material 2 is not particularly limited. However, since the microneedle sheet is a pharmaceutical, a material that is not easily contaminated (contaminated) or a material that does not affect the human body is preferable. For example, SUS316L and Hastelloy are suitably used for metals, and PTFE, polypropylene, polyethylene, and the like are suitably used for plastics.

  Each recess 3 extends in a tapered manner from the surface (one surface (upper surface in FIG. 1)) of the base material 2 toward the back surface (the other surface (lower surface in FIG. 1)). The recess 3 is formed as a conical or pyramidal space having a cross-sectional shape such as a circle, corner, or ellipse. A through hole 4 penetrating the back surface of the base material 2 is formed at the bottom (tip portion) of the recess 3.

  Such a stamper 1 is formed by pressing a flat original plate on which conical projections corresponding to individual microneedles are formed against the stamper base material 2. Alternatively, the stamper 1 may be formed by a method such as injection molding in which a mold is made of a resin melted in an original plate. Although the material of the original plate is not particularly limited, it may be a metal having excellent durability during the production of a stamper or a material with high machinability and low cost. For example, stainless steel, titanium, tungsten, hastelloy, copper, aluminum, nickel, silicon and the like can be used. Further, the protrusion may be formed by a method using photolithography in addition to processing by cutting out from the main body.

  The projections of the original plate have a height of about 1 μm to 500 μm. The height of the protrusion is suitably determined by the body part to be transdermally administered and the specification of the drug. Further, the protrusion has a needle shape in which the ratio of the root cross-sectional diameter to the length has a relatively high aspect ratio in the range of (1) :( 1.5 to 3). The protrusion has a conical shape or a pyramid shape having a cross-sectional shape such as a circle, a corner, or an ellipse. In the stamper base material 2, a plurality of conical recesses 3 corresponding to the plurality of protrusions of the original plate are formed, and these become the stamper 1.

  After the recess 3 is formed in the stamper 1, the through hole 4 is formed in the bottom of the recess 3. The through hole 4 can be formed by a micro drill. Note that the through hole 4 may be formed using a micro drill having a needle-like protrusion on which a spiral blade is not formed.

  Instead of forming the through-hole 4 using a microdrill in this way, the thickness of the base material 2 is made smaller than the height of the projection of the original plate, and the original plate is pressed against the stamper base material 2 to form a recess. A through hole 4 may be formed together.

  Next, FIG. 2 shows a schematic diagram of the base member 5 on which such a stamper 1 is placed in the manufacturing process of the microneedle sheet.

  As shown in FIG. 2, in the base member 5, a concave groove portion 6 is formed on the mounting surface of the stamper 1, and a suction force is applied to the plurality of through holes 4 through the porous member 7 disposed in the groove portion. It is possible to make it. A suction hole 8 is formed at the bottom of the groove 6, and the suction hole 8 is connected to a suction device 10 through a suction pipe 9 and the like. In addition, the porous member 7 is preferably formed of a relatively hard material so that the filling amount does not vary in a filling process using a squeegee of needle raw material, which will be described later. Examples of the porous member 7 include porous polyethylene, ceramic, and metal filter. The base member 5 used here is a metal plate such as stainless steel or aluminum, but the groove 6 can be omitted by using a porous plate such as ceramic.

  Next, the manufacturing method of the microneedle sheet of this Embodiment is demonstrated concretely. In the description, a flowchart showing the procedure of the microneedle sheet manufacturing method is shown in FIG. 3, and schematic explanatory views of the state of the stamper and the like in each procedure (process) are shown in FIGS. 4A to 4G.

  First, in step S1 of the flowchart of FIG. 3, the stamper 1 having the configuration shown in FIG. 1 is prepared, and this stamper 1 is placed on the base member 5 having the configuration shown in FIG. As shown in FIG. 4A, the stamper 1 is placed on the base member 5 so that the respective through holes 4 formed on the back surface of the stamper 1 are located on the porous member 7 disposed in the groove 6 of the base member 5. Placed on top.

  Next, the suction device 10 is operated to apply a suction force to the porous member 7 through the suction tube 9 and the suction hole 8. As a result, suction through the through-holes 4 is started with respect to the respective recesses 3 of the stamper 1 (step S2). In addition, since the suction with respect to the respective through holes 4 is performed through the common porous member 7, the suction force (negative pressure) applied to the respective recesses 3 is almost uniform.

  Next, as shown in FIG. 4A, the first needle raw material 11 is supplied onto the surface of the stamper 1, and the squeegee 13 is moved along the surface of the stamper 1, so that a predetermined amount is obtained in each recess 3. The first needle material 11 is filled (step S3). During the filling process of the first needle raw material 11, filling is performed while air is discharged through the respective through holes 4. Accordingly, the first needle material 11 can be smoothly filled in the recess 3 without air bubbles (air) accumulating. Further, since the common porous member 7 is disposed for the through holes 4 of the plurality of recesses 3, the first needle raw material 11 can be uniformly filled into the respective recesses 3 by the squeegee 13. In the present embodiment, the case where the first needle raw material 11 is filled using the squeegee 13 is illustrated, but filling may be performed using a dispenser. The first needle material 11 may be configured by mixing a drug in a base material common to a second needle material described later. Here, the drug refers to a pure chemical substance having a physiological activity, for example, peptide protein drugs such as insulin, growth hormone, erythropoietin, and interferon, polymer drugs, vitamins, etc. It may be a thing. The first and second needle raw materials are preferably materials that are discharged without remaining in the body.

  Thereafter, as shown in FIG. 4B, the filled first needle material 11 is dried (step S4). This drying process is performed by controlling the drying speed while controlling the evaporation speed from the first needle material 11 by arranging the stamper 1 in a predetermined temperature and humidity environment, for example. As a result, the first needle raw material 11 is solidified in a substantially conical shape at the tip portion in each recess 3, and the first layer 11 of the microneedle (the same reference numeral as the first needle raw material 11 is used). ) Is formed.

  Next, as shown in FIG. 4C, the second needle raw material 12 is supplied onto the surface of the stamper 1, and the squeegee 14 is moved along the surface of the stamper 1, thereby forming the first layer 11. The second needle material 12 is filled in the recess 3 (step S5). During the filling process of the second needle material 12, an external force generated by the movement of the squeegee 14 is applied to the first layer 11 in the recess 3 through the second needle material 12. However, since a suction force is applied to the first layer 11 through the through hole 4 in the recess 3, the first layer 11 is fixed to the tip portion of the recess 3 against such an external force. Become. Therefore, it is possible to prevent the first layer 11 previously filled from being detached from the recess 3 during the filling process of the second needle raw material 12 using the squeegee 14.

  Thereafter, as shown in FIG. 4D, the filled second needle raw material 12 is dried (step S6). In each recess 3, the solvent is evaporated from the second needle raw material 12 to solidify, and a second layer 12 (using the same reference numerals as the second needle raw material 12) joined to the first layer 11 is formed. Is done. In particular, by using a compatible material as a common polymer material for the first needle raw material 11 and the second needle raw material 12, the bonding between the first layer 11 and the second layer 12 can be improved, The integrity of the microneedle having a multilayer structure can be enhanced.

  Next, as shown in FIG. 4E, the adhesive material 16 is disposed using the squeegee 15 on the surface of the stamper 1 in the state where the second layer 12 is formed in each of the recesses 3 (step S7). For example, the squeegee 15 is used in the step of arranging the adhesive material 16. However, since the suction force is continuously applied to the concave portion 3 through the through hole 4, the first layer 11 and the second layer 12 are formed. The separation from the recess 3 is prevented.

  Thereafter, as shown in FIG. 4F, the fixed base 17 is attached on the adhesive material 16 (step S8), and the adhesive material 16 is dried. Thereafter, the suction by the suction device 10 is stopped (step S9), and the fixed base 17 and the adhesive material 16 are peeled off from the surface of the stamper 1. Thereby, the microneedle sheet | seat 20 provided with the some microneedle 21 fixed on the fixed base | substrate 17 via the adhesive material 16 can be obtained (FIG. 4G, step S10). Each microneedle 21 is formed as an integral cone-shaped needle having a two-layer structure including a first layer 11 and a second layer 12.

  Here, the structure of the microneedle 21 which the microneedle sheet | seat 20 manufactured in this way has is demonstrated using the schematic diagram of FIGS.

  In the manufacturing method of the present embodiment, when the first needle raw material 11 is filled, suction through the through hole 4 is performed in the recess 3. Therefore, the first needle raw material 11 filled in the recess 3 is adsorbed and fixed by a minute suction force. Therefore, a flat surface 21a can be formed at the tip of the microneedle 21 as shown in FIG. 5, or a convex portion 21b slightly protruding at the tip can be formed as shown in FIG.

  On the other hand, when the first needle raw material 11 is filled without applying a suction force, there is a high tendency to form a recess 81a at the tip as in the microneedle 81 shown in FIG. This is presumed that the first needle material 11 is dominated by the interfacial tension with the stamper base material 2 because the through hole 4 is formed in the recess 3 but no suction force is applied. .

  In order to penetrate the skin, the tip diameter of the microneedle 21 is preferably 20 μm or less, more preferably about 10 μm. Furthermore, it is preferable that the tip of the microneedle 21 is sharpened. By performing suction through the through-hole 4 during filling and drying of the first needle raw material 11, it is possible to suppress the separation of the microneedle 21 and to sharpen the tip of the microneedle 21. In addition, the diameter of each through-hole 4 is set according to the front-end | tip diameter of the microneedle 21 requested | required, for example, is set in the range of 1 micrometer-20 micrometers.

  5 and FIG. 6, the layer interface between the first layer 11 and the second layer 12 in the microneedle 21 is a substantially flat surface. In this way, when the interface is a flat surface, it becomes easy to manage the filling amount of the first needle raw material 11 in each recess 3 with the volume based on the shape of the first layer 11 after filling. On the other hand, in the microneedle 21 shown in FIG. 8, this layer interface is not flat but curved. When the layer interface is curved as described above, the contact area between the first layer 11 and the second layer 12 can be increased, and the bonding strength can be increased. In addition, the form of such a layer interface can be controlled to a desired shape by the suction force through the through hole 4, the drying time of the first needle material 11 (for example, temperature and humidity environment conditions), and the like.

  According to the microneedle sheet manufacturing method of the present embodiment, the surface of the stamper 1 using the squeegee 14 while sucking through the through hole 4 with respect to the concave portion 3 of the stamper 1 filled with the first needle material 11. The second needle raw material 12 is filled into the respective recesses 3. When the second needle material 12 is filled, the first needle material 11 (first layer 11) previously filled is fixed to the tip portion in the recess 3 by suction through the through-hole 4; Therefore, when filling the 2nd needle raw material 12 using the squeegee 14, it can prevent that the 1st layer 11 detaches | leaves out of the recessed part 3, and can obtain predetermined | prescribed needle height. Therefore, the amount of drug contained in the tip portion can be kept uniform between the microneedles 21.

  In addition, when the adhesive material 16 is disposed on the surface of the stamper 1 using the squeegee 15, since the suction force is applied to the recess 3 through the respective through holes 4, the first layer 11 and It is possible to prevent the second layer 12 from separating.

  Furthermore, when filling the first needle raw material 11 into the concave portion 3, the inside of the concave portion 3 is sucked through the through hole 4, so the first needle raw material 11 is filled to the tip of the conical concave portion 3. can do. Therefore, it is possible to prevent the tip from becoming concave, and the sharpened microneedle 21 can be formed. Furthermore, the microneedle 21 can be sharpened by sucking the inside of the recess 3 through the through hole 4 when the first needle raw material 11 is dried.

  Further, when the needle raw materials 11 and 12 filled in the recess 3 and the adhesive material 16 are dried, the needle raw materials 11 and 12 and the adhesive material 16 may shrink in volume. However, since a suction force is applied to the recess 3 through the through hole 4, the needle material is fixed in the recess 3 against the drying stress generated in the needle materials 11, 12 and the adhesive material 16. The Therefore, it is possible to prevent the needle raw material from detaching from the recess 3 during such a drying process.

  The suction force applied to the recess 3 through each through hole 4 is preferably set to such an extent that the first needle material 11 does not escape from the through hole 4. Although it depends on the physical properties of the first needle raw material 11 to be used and the diameter of the through-hole 4, it is preferable to set the suction pressure in the range of −1 kPa to −10 kPa with the atmospheric pressure set to 0 kPa.

  Further, considering that the first needle material 11 is slightly removed from each through-hole 4 and adheres to the porous member 7, only the upper layer to which the material is adhered is replaced with a porous member having a two-layer structure. May be.

  Further, a common porous member 7 may be provided for a group of the plurality of through holes 4, or a common porous member may be provided for a plurality of groups.

  In the above description, the suction into the recess 3 through each through-hole 4 is continuously performed from the filling process (step S3) of the first needle raw material 11 to the placement process (step S8) of the fixed base 17. Although the case is taken as an example, the present invention is not limited to such a case. Step of drying the first needle material 11 (Step S4), Step of filling the second needle material 12 (Step S5), Step of drying the second needle material 12 (Step S6), Step of arranging the adhesive material 16 (Step) S7) If at least suction through the through-hole 4 is performed in any of the steps of drying the adhesive material 16, the first layer 11 or the second layer 12 can be prevented from being detached from the recess 3. .

  In the above description, the microneedle is prevented from being detached by suction. However, if a negative pressure difference from the front surface to the back surface of the stamper base material 2 is generated, the separation can be prevented. It is not limited.

  In addition, the case where the microneedle 21 has a two-layer structure has been described as an example for convenience. Further, a filling method other than the squeegee, for example, an ink jet method in which specific concave portions are discharged and filled, or a filling method by dispensing that is applied to a predetermined position can be used.

  It is to be noted that, by appropriately combining arbitrary embodiments of the various embodiments described above, the effects possessed by them can be produced.

  The present invention can be widely used not only for a microneedle sheet for injecting a drug into the epidermis, but also for a method for forming microprojections on a substrate.

DESCRIPTION OF SYMBOLS 1 Stamper 2 Base material 3 Recessed part 4 Through-hole 5 Base member 6 Groove part 7 Porous member 8 Suction hole 9 Suction pipe 10 Suction device 11 1st needle raw material, 1st layer 12 2nd needle raw material, 2nd layer 13- 15 Squeegee 16 Adhesive Material 17 Fixed Base 20 Microneedle Sheet 21 Microneedle

Claims (9)

A method of manufacturing a microneedle sheet,
A stamper preparation step of preparing a sheet-shaped stamper having a plurality of conical concave portions extending tapered from the front surface to the back surface of the sheet-shaped base material and through holes penetrating from the bottom of each concave portion to the back surface When,
A suction step that sucks from the through hole on the back surface of the base material and creates a negative pressure difference on the back surface side with respect to the front surface side of the base material;
A filling step of filling the needle material into each recess from the surface of the stamper;
A needle raw material drying step of drying the needle raw material filled in the recess,
At least during the needle material drying process ,
A method of manufacturing a microneedle sheet, wherein, in the suction step, the porous member disposed on the back surface of the stamper is sucked so that the recesses are sucked through the respective through-holes through the porous member . A method of manufacturing a microneedle sheet,
A stamper preparation step of preparing a sheet-shaped stamper having a plurality of conical concave portions extending tapered from the front surface to the back surface of the sheet-shaped base material and through holes penetrating from the bottom of each concave portion to the back surface When,
A suction step that sucks from the through hole on the back surface of the base material and creates a negative pressure difference on the back surface side with respect to the front surface side of the base material;
A filling step of filling the needle material into each recess from the surface of the stamper;
An adhesive material placement step of placing an adhesive material on the surface of the stamper;
A fixing base placement step of attaching a fixing base to the adhesive material and fixing the needle material in each recess to the fixing base via the adhesive material,
At least during the implementation of the adhesive material placement process ,
A method of manufacturing a microneedle sheet, wherein, in the suction step, the porous member disposed on the back surface of the stamper is sucked so that the recesses are sucked through the respective through-holes through the porous member . The method further includes an adhesive material drying step of drying the adhesive material after the fixed base plate arranging step,
The manufacturing method of the microneedle sheet | seat of Claim 2 which implements a suction process during implementation of an adhesive material drying process.   The manufacturing method of the microneedle sheet | seat as described in any one of Claim 1 to 3 which implements a suction process during implementation of a filling process. A method of manufacturing a microneedle sheet,
A stamper preparation step of preparing a sheet-shaped stamper having a plurality of conical concave portions extending tapered from the front surface to the back surface of the sheet-shaped base material and through holes penetrating from the bottom of each concave portion to the back surface When,
A suction step that sucks from the through hole on the back surface of the base material and creates a negative pressure difference on the back surface side with respect to the front surface side of the base material;
A first filling step of filling the first needle material into the respective recesses from the surface of the stamper;
A second filling step of filling the second needle raw material into each of the recesses filled with the first needle raw material,
Performing a suction step during at least the second filling step ;
A method of manufacturing a microneedle sheet, wherein, in the suction step, the porous member disposed on the back surface of the stamper is sucked so that the recesses are sucked through the respective through-holes through the porous member . A method of manufacturing a microneedle sheet,
A stamper preparation step of preparing a sheet-shaped stamper having a plurality of conical concave portions extending tapered from the front surface to the back surface of the sheet-shaped base material and through holes penetrating from the bottom of each concave portion to the back surface When,
A suction step that sucks from the through hole on the back surface of the base material and creates a negative pressure difference on the back surface side with respect to the front surface side of the base material;
A first filling step of filling the first needle material into the respective recesses from the surface of the stamper;
A second filling step of filling the second needle raw material into the respective recesses filled with the first needle raw material;
An adhesive material placement step of placing an adhesive material on the surface of the stamper;
A fixing base placement step of attaching a fixing base to the adhesive material and fixing the needle material in each recess to the fixing base via the adhesive material,
At least during the implementation of the adhesive material placement process ,
A method of manufacturing a microneedle sheet, wherein, in the suction step, the porous member disposed on the back surface of the stamper is sucked so that the recesses are sucked through the respective through-holes through the porous member . A method of manufacturing a microneedle sheet,
A stamper preparation step of preparing a sheet-shaped stamper having a plurality of conical concave portions extending tapered from the front surface to the back surface of the sheet-shaped base material and through holes penetrating from the bottom of each concave portion to the back surface When,
A suction step of sucking from the through-hole on the back surface of the base material and creating a negative pressure difference on the back surface with respect to the front surface side of the base material;
A first filling step of filling the first needle material into the respective recesses from the surface of the stamper;
A first raw material drying step of drying the first needle raw material filled in the recess;
A second filling step of filling the second needle raw material into the respective recesses filled with the first needle raw material;
A second raw material drying step of drying the second needle raw material filled in the recess,
Performing the suction step at least during the first raw material drying step or the second raw material drying step ,
A method of manufacturing a microneedle sheet, wherein, in the suction step, the porous member disposed on the back surface of the stamper is sucked so that the recesses are sucked through the respective through-holes through the porous member . The method further includes an adhesive material drying step of drying the adhesive material after the fixed base plate arranging step,
The manufacturing method of the microneedle sheet | seat of Claim 6 which implements a suction process during implementation of an adhesive material drying process.   The method for producing a microneedle sheet according to any one of claims 5 to 8, wherein the suction step is performed during the first filling step.

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