JP2014097163A - Method of manufacturing microneedle array - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method of manufacturing a microneedle array, which enables efficient mass-production of the microneedle array having a microneedle assuming a pointed shape.SOLUTION: This method of manufacturing a microneedle array includes steps of: protruding a large number of resin ultrathin columnar bodies 2p as a group on a surface of a sheet-like basis material 11a; molding a group of microneedles 2G by forming at least a tip of each ultrathin columnar body 2p in a pointed shape by a chemical solution; and forming a base material 1 in a constant shape by cutting the basis material 11a on the periphery of the group of microneedles 2G.

Description

  The present invention relates to a method of manufacturing a microneedle array for manufacturing a microneedle array in which a large number of microneedles that puncture the skin are provided on a substrate.

  As a method for administering a drug into the human body, there is a transdermal administration method in which the drug is absorbed into the body by applying the drug to the skin. As a transdermal administration method, a method in which a microneedle is punctured to the skin epidermis layer or the skin stratum corneum by about 0.2 to 0.8 mm has been proposed.

  The microneedles are formed into a pointed shape with a metal or resin, and are used in a state where a drug is applied. Alternatively, the microneedle is formed into a tip shape using a material containing a drug in skin components such as collagen and hyaluronic acid.

  In any case, a microneedle array in which a large number of microneedles are provided on a substrate is called a microneedle array, and a product obtained by adding an adhesive sheet or a packaging material (cover sheet) to the substrate of the microneedle array is a microneedle. It is called a patch. This type of microneedle patch can maintain a state in which the microneedle is punctured into the skin by the adhesive sheet being stably adhered to the skin for a long time. The microneedle patch is sealed in a sterile state by the packaging material until the microneedle array is used.

  Here, the microneedle patch described in Patent Document 1 will be described with reference to FIG. This microneedle patch P has a configuration in which an adhesive layer 120 is laminated on a microneedle array 110.

  The microneedle array 110 includes an ultra-thin disc-shaped substrate 111, a thick holding portion 111a formed at the center of the surface of the substrate 111, and a large number of microneedles 112 protruding from the holding portion 111a. I have. The substrate 111 is formed from a polyester medical tape. And the adhesive bond layer 120 is laminated | stacked on the surface of the base material 111 except the holding | maintenance part 111a. The adhesive layer 120 is laminated so as not to protrude from the surface of the holding portion 111a.

  For transdermal administration using such a microneedle patch P, the drug is applied directly to the skin, or the drug is applied to the microneedle 112 and the microneedle 112 is punctured into the skin. Further, the microneedle patch P is brought into close contact with the skin by the adhesive layer 120, the state where the microneedle 112 is punctured into the skin is maintained, and the drug is administered into the body.

Japanese translation of PCT publication No. 2008-522731

  Various methods, including Patent Document 1, have been proposed for individually manufacturing the microneedle array 110. However, since a method for mass-producing the microneedle array 110 has not been proposed, the microneedle array 110 is expensive.

  Then, this invention makes it a subject to provide the manufacturing method of the microneedle array which enabled mass production of the microneedle array which has a microneedle of a pointed shape efficiently.

  The method for producing a microneedle array according to the present invention is a method for producing a microneedle array for producing a microneedle array in which a large number of microneedles are provided on the surface of a substrate, and the method is provided on the surface of a sheet-like substrate. And a step of forming a group of microneedles by making at least the tip of each ultrafine columnar body into a pointed shape with a chemical solution.

  According to this method for manufacturing a microneedle array, a chemical solution is used to form microneedles having a pointed shape from a resin-made ultra-thin columnar body that is projected in large numbers on the surface of a sheet-like substrate. Although it is relatively easy to form a very fine columnar body, it was difficult to form a pointed microneedle. Microneedles can be easily formed. The distal end shape may be reduced only in the distal end portion or may be a conical shape reduced in diameter from the proximal end portion.

  Further, as one aspect of the method for manufacturing the microneedle array, a plurality of strips are formed by cutting the sheet-like substrate with a constant width so that the group of ultrafine columnar bodies are arranged in one or a plurality of rows. It is possible to employ a configuration including a step and a step of manufacturing a long substrate by joining the strips in the length direction before the step of forming a group of microneedles.

  According to this method for manufacturing a microneedle array, a long substrate can be manufactured by forming a strip from a sheet-like substrate and connecting the strips in the length direction. A long substrate is easy to store by being wound in a roll shape, and further, the operation of cutting the substrate in a subsequent process can be made efficient by feeding it out in the length direction.

  Moreover, as another aspect of the manufacturing method of the microneedle array, a configuration including a step of forming a base material having a fixed shape by cutting the substrate around the group of microneedles can be adopted.

  According to this method for producing a microneedle array, a substrate having a fixed shape is formed by cutting the substrate, but a group of ultra-thin columnar bodies project on the surface of a sheet-like or long substrate with a fixed interval. Therefore, the ultrathin columnar body is not cut. Therefore, no load is applied to the cutting blade used for cutting, and the substrate can be cut into a predetermined shape.

  Moreover, as another aspect of the manufacturing method of the microneedle array, there are provided a step of facing two substrates using a fabric with a space therebetween, and a plurality of locations so as to sew a filamentous filament between the two substrates It is possible to adopt a configuration including a step of spanning and a step of projecting a large number of ultrafine columnar bodies as a group on the surface of the substrate by cutting a large number of filaments between the two substrates.

  According to this microneedle array manufacturing method, thread-like filaments are bridged at a number of locations between two substrates facing each other at an interval, and the filaments are cut between the two elements. In particular, the ultrafine columnar body can be protruded from the surface of the substrate. According to this method, it is possible to manufacture two sets of a large number of ultra-thin columnar bodies projected on the substrate by cutting the filament.

  Moreover, as another aspect of the manufacturing method of the drug-added microneedle array, a configuration in which the base, the ultrathin columnar body, and the resin are integrally molded by injection molding may be employed.

  According to this microneedle array manufacturing method, since the base material is made of the same resin as the ultrathin columnar body, the microneedle patch can be efficiently manufactured by injection molding. In the injection molding, a mold is used, but the mold is formed with recesses corresponding to the thickness of the substrate, a plurality of elongated holes are formed in the recesses, and the elongated holes are filled with a molten resin to be melted. As the resin solidifies, a large number of ultra-thin columnar bodies are molded together.

  As another aspect of the method for producing the microneedle array, a step of laminating a drug impregnated layer on the surface of the substrate with the tip of the ultrafine columnar body exposed, and impregnating the drug impregnated layer with the drug A configuration including steps can be employed.

  According to this method for manufacturing a microneedle array, a drug-impregnated layer is laminated on the surface of the substrate, and the drug-impregnated layer is impregnated with the drug, whereby the manufactured microneedle array is in a state in which the drug is added. Therefore, in this method, it is not necessary to add a drug to the manufactured microneedle array in a separate process.

  Further, as a preferred embodiment of the method for producing the drug-added microneedle array, it is possible to adopt a configuration in which the ultrafine columnar body is made of a polyester resin and the chemical solution is an alkaline aqueous solution.

  According to this method for producing a drug-added microneedle array, a tip-shaped microneedle can be easily and efficiently produced from an ultrathin columnar body. That is, the extra fine columnar body made of polyester resin is attached by being immersed in an alkaline aqueous solution, so that the extra fine columnar body is gradually decomposed from the surface by the alkaline aqueous solution. That is, when polyester comes into contact with an aqueous alkali solution, it is hydrolyzed to produce an aromatic dibasic acid and a dihydric alcohol, and the dibasic acid is further converted into an alkali salt by the aqueous alkali solution. Since both the alkali salt and the dihydric alcohol are dissolved in the alkaline aqueous solution, the ultrathin columnar body is decomposed from the surface to have a pointed shape.

  According to the present invention, microneedle arrays having pointed microneedles can be mass-produced one after another efficiently.

FIG. 1 is a first embodiment of a method of manufacturing a microneedle array according to the present invention, in which (a) is a schematic cross-sectional view showing an initial process, (b) is a schematic cross-sectional view showing an intermediate process, (C) is a schematic sectional drawing which shows an intermediate | middle process. FIG. 2 is a schematic perspective view showing the first step in the first embodiment of the method of manufacturing the microneedle array. FIG. 3 is a schematic perspective view showing an intermediate step in the first embodiment of the manufacturing method of the microneedle array. FIG. 4 is a schematic perspective view showing an intermediate step in the first embodiment of the manufacturing method of the microneedle array. FIG. 5 is a schematic front view showing an example of a microneedle patch manufacturing apparatus. FIG. 6 is a partially cutaway schematic perspective view showing a state in which a concave portion is formed in the support raw material while the microneedle patch is being manufactured by the microneedle patch manufacturing apparatus. FIG. 7 is a schematic cross-sectional front view showing a state in which the microneedle array is housed in the recessed portion of the support original while the microneedle patch is being manufactured by the microneedle patch manufacturing apparatus. FIG. 8 shows a stage in which a microneedle patch is being manufactured by a microneedle patch manufacturing apparatus and a pressure sensitive adhesive sheet is overlapped with a support material, and (a) is a partially broken schematic perspective view. (B) is a schematic sectional front view. FIG. 9 is a partially broken schematic perspective view showing a stage in which a cut is made in the adhesive sheet raw material while the microneedle patch is being manufactured by the microneedle patch manufacturing apparatus. FIG. 10 is a partially broken schematic perspective view and a schematic perspective view of a microneedle patch with a support. FIG. 11 is a second embodiment of the method of manufacturing a microneedle array according to the present invention, in which (a) is a schematic cross-sectional front view showing a mold used in the second embodiment, and (b) is a first view. FIG. 4C is a schematic cross-sectional front view showing the process, FIG. 4C is a schematic cross-sectional front view showing the intermediate process, and FIG. 4D is a schematic cross-sectional view showing the intermediate process. FIG. 12 is a schematic perspective view showing an example of a conventional microneedle patch.

[First Embodiment]
A first embodiment of a method for manufacturing a microneedle array according to the present invention will be described with reference to FIGS. Each drawing is schematically drawn.

  The manufacturing method of the microneedle array of the first embodiment is a manufacturing method in which a group of resin microneedles 2 (hereinafter referred to as “microneedle group”) 2G is provided on a base material 1 of a fabric. As the fabric, a net cloth or a woven fabric is used, and the base material 1 is formed by cutting the sheet-shaped base (simple) 11a.

  As shown in FIG. 1A, a drug impregnated layer 11b is previously laminated on the surface of the substrate 11a, and a drug shielding layer 11c is laminated on the back surface of the substrate 11a. Hereinafter, the three-layer body of the bonded drug-impregnated layer 11b, the substrate 11a, and the drug-shielding layer 11c is referred to as a laminate 11.

  A liquid or viscous drug penetrates into the drug-impregnated layer 11b in a later step. Therefore, the drug-impregnated layer 11b is formed into a fabric shape with hygienic and hygroscopic cotton, hemp, silk, sponge, and the like.

  In addition, since the base material 1 is a fabric, the liquid or viscous drug that has penetrated into the drug-impregnated layer 11b does not bleed out from the base material 1, so that the liquid or viscous substance does not penetrate. The shielding layer 11c is bonded to the back surface of the substrate 11a. Therefore, the drug shielding layer 11c is formed of a plastic film or the like.

  As shown in FIG. 1B, the stacked body 11 is arranged so that the drug-impregnated layers 11b face each other with a space therebetween. The distance between the drug-impregnated layers 11b facing each other is, for example, about 0.2 to 1.5 mm.

  Then, in order to project the planar microneedle group 2G from the substrate 11a, as shown in FIG. 1A, a thread-like filament 2f is bridged between the two laminates 11, and the two laminates 11 are integrated. Turn into. A monofilament is preferably used as the filament 2f, but a multifilament may be used. In FIG. 2, a filament bridge portion 2K for forming the microneedle group 2G is illustrated, and the filament bridge portion 2K is illustrated as being provided in a circular shape, but may be provided in a square shape or the like. .

  In the microneedle group 2G, one filament 2f is bent toward the drug-impregnated layer 11b along the outer surface of one drug shielding layer 11c, for example, about 1 mm, and is formed on the outer surface of the other drug shielding layer 11c. A large number of filaments 2f are formed in two layers by being sewed in a meandering manner so as to be bent through the outer surface of the other drug shielding layer 11c, for example, about 1 mm toward the drug impregnated layer 11b. A filament bridging portion 2 </ b> K in a state of being spanned between 11 is provided.

  In this filament bridging portion 2K, a large number of filaments 2f project vertically as a group from one drug-impregnated layer 11b toward the other drug-impregnated layer 11b, but one filament 2f is sewn and provided in a group. Alternatively, a plurality of filaments 2f may be sewn and provided in a group.

  In any case, a plurality of groups of filament bridging portions 2K are partially provided in the laminate 11 as shown in FIG. A line connecting the plurality of filament bridging portions 2K is linear. In other words, the plurality of filament bridging portions 2K are scattered so as to be arranged in a straight line.

  The filament 2f is, for example, a polyester resin and has a diameter of, for example, about 0.05 to 0.5 mm.

  And in 1st Embodiment, the filament 2f of the some filament bridge | crosslinking part 2K is cut | disconnected collectively. That is, the filament 2f is cut in the middle of the two drug-impregnated layers 11b as shown by a two-dot chain line in FIG. 1 (a), and as shown in FIG. A number of ultrafine columnar bodies 2p are projected as a group. Each ultrathin columnar body 2p has a cylindrical shape protruding from the substrate 11a by, for example, 0.025 to 0.25 mm, and the tip is not sharp.

  Moreover, the two laminated bodies 11 which were integrated are isolate | separated into the two laminated bodies 11 by the filament 2f being cut | disconnected. Each laminated body 11 is in a state in which a plurality of ultrafine columnar bodies 2p (hereinafter referred to as “extrafine columnar body group 2Q”), each grouping, are projected in a plurality of groups. Subsequently, each stacked body 11 is cut so that the ultra-thin columnar body groups 2Q are arranged in a line to form a strip-shaped body 12. This belt-like body 12 has a structure in which a belt-like drug-impregnated layer 11b is laminated on the surface of a belt-like substrate 11a, and a belt-like drug shielding layer 11c is laminated on the back surface of the belt-like substrate 11a. In addition, the strip | belt shaped object 12 is good also as what arranged the ultra-thin columnar body group 2Q in 2 or more rows.

  As shown in FIG. 3, the plurality of strips 12 are joined in the length direction to form a long substrate 13. Of course, the ultrathin columnar body 2p protrudes from the long substrate 13 in the same direction, and the ultrathin columnar body 2p penetrates the chemical liquid impregnated layer 11b.

  And the front-end | tip part of this ultrafine columnar body 2p is immersed in the chemical | medical solution L, as shown in FIG.1 (c). As the chemical liquid L, for example, an alkaline aqueous solution is used. The ultra-thin columnar body 2p is formed with a constant outer diameter from the root portion to the tip portion by a polyester resin. However, polyester is hydrolyzed by contact with an aqueous alkali solution to produce an aromatic dibasic acid and a dihydric alcohol. And a dibasic acid becomes an alkali salt further by aqueous alkali solution.

  Both alkali salts and dihydric alcohols are dissolved in an alkaline aqueous solution. Therefore, the ultrathin columnar body 2p is disassembled from the surface, and becomes a microneedle 2 having a pointed shape as shown in FIG. A large number of microneedles 2 are collectively formed by immersing the ultra-thin columnar body group 2Q in an alkaline aqueous solution.

  A long substrate 13 provided with a large number of microneedles 2 as a group and spaced apart is wound and stored as a microneedle array raw fabric 14 in a roll shape.

  And the microneedle array original fabric 14 is set to the array supply mechanism 40 with which the microneedle patch manufacturing apparatus as shown in FIG. 5 was equipped. The array supply mechanism 40 is a cutter that allows a liquid or viscous drug to permeate the drug-impregnated layer 11b laminated on the microphone needle array original fabric and cuts the microneedle array original fabric 14 around a large number of microneedle groups 2G. (Not shown).

  Since the microneedle array raw fabric 14 projects the microneedle group 2G at regular intervals, it has a portion where the microneedle group 2G does not project. Therefore, the cutter cuts the microneedle array raw fabric 14 around the microneedle group 2G without cutting the microneedles 2.

  A mechanism for impregnating the drug-impregnated layer 11b with the drug may be provided separately from the array supply mechanism 40, and the drug-impregnated layer 11b may be wound in a roll and stored in a state in which the drug-impregnated layer 11b is impregnated.

  As shown in FIG. 5, the microneedle patch manufacturing apparatus is an apparatus for manufacturing a microneedle patch P in which the microneedle array 110 is packaged by causing the support original 101 and the adhesive sheet 105 to advance in the length direction. It is.

  For this reason, the microneedle patch manufacturing apparatus is provided with a support material supply mechanism 20 that feeds the support material 101 wound in a roll shape in the length direction at the uppermost stream, and a recess is formed on the downstream side. The mechanism 30, the array supply mechanism 40, the adhesive sheet original fabric supply mechanism 50, and the cutting mechanism 60 are arranged in order in the horizontal direction.

  The recessed portion forming mechanism 30 forms a large number of recessed portions (not shown) on the outer peripheral surface center line of a cylindrical forming drum 31 that rotates in the circumferential direction, and pushers (not shown) enter and leave the recessed portions. It is supposed to be configured. The support original fabric 101 is partially wound around the outer peripheral surface of the forming drum 31, and the pusher enters and exits into the recess through the support original fabric 101. A strip-shaped molded sheet 103 provided with continuous recesses 103a is formed at regular intervals.

  A stepped portion 103b on which the peripheral portion of the microneedle array 110 is placed is formed in the recessed portion 103a. Even if the tip portion of the microneedle 2 is housed in the recessed portion 103a downward, the outer peripheral portion of the microneedle array 110 is placed on the stepped portion 103b, so that the tip portion of the microneedle 2 moves the bottom portion 103c of the recessed portion 103a. It is possible not to pierce and pierce, and to prevent the tip shape from being crushed.

  The array supply mechanism 40 supplies the microneedle array 110 manufactured by cutting the microneedle array original fabric 14 into the recessed portion 103 a of the molded sheet 103. That is, the recessed portion 103a of the molded sheet 103 passes below the array supply mechanism 40 at a certain timing. Therefore, the array supply mechanism 40 supplies the microneedle array 110 into the recess 103a at the timing when the recess 103a of the molded sheet 103 passes as shown in FIG.

  And the adhesive sheet original fabric supply mechanism 50 overlaps the adhesive sheet original fabric 105 on the shaping | molding sheet 103, as shown in FIG. The pressure-sensitive adhesive sheet original fabric 105 is provided with a pressure-sensitive adhesive layer only on the back surface, and this back surface is bonded to the molded sheet 103. By this bonding, the microneedle array 110 in the recess 103a is sealed. The microneedle array 110 is laminated with a drug impregnated layer 11b impregnated with a drug, but the drug does not soak into the adhesive sheet original 105 by the drug shielding layer 11c.

  Then, as shown in FIG. 9, the cutting mechanism 60 includes a first cutting mechanism 61 (see FIG. 5) for making a cut 105a only in the original adhesive sheet 105 bonded to the molded sheet 103, and as shown in FIG. In addition, a second cutting mechanism 62 (see FIG. 5) for cutting the molded sheet 103 is combined.

  The adhesive sheet 5 is formed by making a cut 105 a in the adhesive sheet original fabric 105 by the first cutting mechanism 61, and the scrap 105 s formed around the adhesive sheet 5 is peeled off from the molded sheet 103. Further, the second cutting mechanism 62 cuts the molded sheet 103 slightly larger than the pressure-sensitive adhesive sheet 5, thereby separating the molded sheet scrap 103 s to complete the microneedle patch P having the support 3.

  The microneedle patch P hygienicly seals the microneedle array 110. In use, the microneedle array 110 is taken out from the recessed portion 103 a of the support 3 by peeling the adhesive sheet 5 from the support 3.

  Since the microneedle array 110 includes a drug-impregnated layer 11b containing a drug, the drug can be transdermally administered by puncturing the microneedle 2 into the skin. Moreover, the state in which the microneedle 2 punctured the skin is maintained by the adhesive sheet 5 sticking to the skin.

[Second Embodiment]
A second embodiment of the microneedle array manufacturing method according to the present invention will be described with reference to FIG. In addition, FIG. 11 is drawn typically.

  The manufacturing method of the microneedle array of 2nd Embodiment is a method of providing the resin-made microneed group in the resin-made base material 1. FIG. Therefore, when the microneedle 2 is formed of a polyester resin, the substrate 1 is also formed of a polyester resin.

  Since the base 1 and the microneedles 2 are formed from the same resin, the microneedle array 110 is manufactured by injection molding. That is, in the second embodiment, a mold 80 as shown in FIG. 11A is used. In this mold 80, a concave portion 81 corresponding to the thickness of the substrate is formed on a flat plate, and a large number of elongated holes 82 are formed in the concave portion 81. The inner diameter of the elongated hole 82 is the same as the outer diameter of the microneedle 2, and the depth of the elongated hole 82 is the same as the length of the microneedle 2.

  By pouring and solidifying the molten resin into the large number of the elongated holes 82 and the recesses 81, as shown in FIG. 11B, a large number of ultra-thin columnar bodies 2p project from the sheet-like substrate 11a. . As in the first embodiment, a large number of extra-fine columnar bodies 2p are provided so as to form an extra-thin columnar body group 2Q and are scattered at a certain interval in the sheet-like substrate 11a. Therefore, the line connecting the ultra-thin columnar body groups 2Q is linear.

  Then, the base body 11a is cut with a certain width so that the ultrathin columnar body groups 2Q are arranged in one row, thereby forming the strip-like body 12. As described in the first embodiment, the strip 12 is joined in the length direction to form a long substrate 13 (see FIG. 3). The long substrate 13 is formed by projecting the ultrathin columnar body group 2Q in the same direction with a certain interval.

  And as demonstrated in 1st Embodiment, the tip part of the extra-fine columnar body 2p was made into the pointed shape as shown in FIG.11 (c) by immersing the front-end | tip part of the extra-fine columnar body 2p in a chemical | medical solution. The microneedle 2 is formed. When the ultra-thin columnar body is formed of a polyester-based resin, a large number of microneedles 2 can be collectively formed as described in the first embodiment by using, for example, an alkaline aqueous solution as a chemical solution. it can.

  And as shown in FIG.11 (d), the strip | belt-shaped chemical | medical agent impregnation layer 11b is piled up on the surface of the elongate base 13. FIG. Since the microneedle 2 formed on the long substrate 13 has a pointed shape, the drug-impregnated layer 11b pierces the microneedle 2, overlaps the surface of the long substrate 13, and the drug-impregnated layer 11b The tip is protruding. Thereafter, the drug-impregnated layer 11b is impregnated with a liquid or viscous drug. However, the drug-impregnated layer 11b impregnated with the drug may be superposed on the surface of the strip.

  In the second embodiment, the base material 1 is made of resin, and the drug impregnated in the drug impregnated layer 11b does not enter the base material 1. Therefore, the drug shielding layer 11c is not provided.

  Also in the second embodiment, as described in the first embodiment, the microneedle array original fabric 14 is set in the array supply mechanism 40 of the microneedle patch manufacturing apparatus shown in FIG. The microneedle array 110 is manufactured by cutting around the microneedle group 2G. As described in the first embodiment, since the microneedle array 2G does not protrude over the entire length, the microneedle array raw fabric 14 cuts the long substrate 13 at a portion where the microneedle array 110 does not protrude. can do.

  In the second embodiment, the microneedle patch P including the microneedle array 110 is manufactured as described in the first embodiment.

[Other Embodiments]
The present invention can be variously modified without being limited to the first and second embodiments. For example, the microneedle array 110 does not necessarily include the drug impregnated layer 11b. When manufacturing the microneedle array 110 that does not include the drug-impregnated layer 11b, the microneedle patch manufacturing apparatus includes a drug filling mechanism (not shown).

  This medicine filling mechanism is disposed between the recessed portion forming mechanism 30 and the array supply mechanism 40. The drug filling mechanism fills the recess 103 a formed on the support original fabric 101 by the recess forming mechanism 30 with the drug. And the chemical | medical agent can be transdermally administered from the microneedle 2 because the front-end | tip part of the microneedle 2 of the microneedle array 110 supplied in the recessed part 103a is immersed in a chemical | medical agent.

  In the first and second embodiments, the drug-impregnated layer 11b is impregnated with the drug in the state of the long substrate 13 by the array supply mechanism 40. In the stage before setting the array supply mechanism 40, You may make a chemical | medical agent impregnate the chemical | medical agent impregnation layer 11b laminated | stacked on the sheet-like base material 11a.

  Moreover, you may shape | mold the ultrafine columnar body 2p with a polyamide-type resin etc., without being limited to a polyester-type resin. In addition, the chemical solution is changed from an alkaline aqueous solution to various chemical solutions according to the material of the ultrathin columnar body 2p.

  The substrate 1 may be formed by cutting the sheet-like substrate 11a without cutting the sheet-like substrate 11a and cutting the long substrate 13. Further, although the microneedle 2 is illustrated as having a pointed shape only at the tip portion, it may be formed in a conical shape or a pyramid shape gradually tapering from the root portion to the tip portion. Furthermore, although it is preferable that the microneedle 2 protrudes from the substrate 11a at a constant interval from the viewpoint of productivity, it may protrude unevenly from the substrate 11a.

  In the first embodiment, the filament 2f extends along the exposed surface of the chemical solution shielding layer 11b. However, the filament 2f extends along the back surface of the substrate 11a, and the filament 2f is covered with the chemical solution shielding layer 11b. Also good.

1 ………… Base material 2 ………… Microneedle 2G ………… A group of microneedles (microneedle group)
2K ………… Filament bridging part 2Q ………… A group of extra fine columnar bodies (extra fine columnar group)
2f ………… Filament 2p ………… Extremely thin columnar body 11 ………… Laminated body 11a ………… Base 11b ……… Drug impregnated layer 11c ……… Drug shielding layer 12 ………… Strip 13 …… Long substrate 14 ………… Microneedle array material 110 ……… Microneedle array

Claims (7)

A method for producing a microneedle array for producing a microneedle array having a large number of microneedles on the surface of a substrate,
Projecting a large number of resin-made fine columnar bodies as a group on the surface of a sheet-like substrate, and forming a group of microneedles by forming at least the tip of each ultrafine columnar body with a chemical solution into a pointed shape. A method for producing a microneedle array, comprising:   A step of forming a plurality of strips by cutting the sheet-like substrate at a constant width so that the group of ultra-thin columnar bodies are arranged in one row or a plurality of rows, and joining the strips in the length direction; 2. The method of manufacturing a microneedle array according to claim 1, wherein the step of manufacturing a long substrate is included before the step of forming a group of microneedles.   3. The method of manufacturing a microneedle array according to claim 1, further comprising the step of forming a substrate having a fixed shape by cutting the substrate around the group of microneedles.   A step of facing two substrates using cloth with a space therebetween, a step of crossing yarn-like filaments at a number of places so as to sew between the two substrates, and a large number of fibers between the two substrates The method of manufacturing a microneedle array according to any one of claims 1 to 3, further comprising a step of projecting a number of ultra-thin columnar bodies as a group on the surface of the substrate by cutting the filament. Method.   The method of manufacturing a microneedle array according to any one of claims 1 to 3, wherein the substrate, the ultra-thin columnar body, and the resin are integrally molded by injection molding.   2. The method includes the steps of: laminating a drug impregnated layer on the surface of the substrate with the tip of the ultrafine columnar body exposed; and impregnating the drug impregnated layer with a drug. The manufacturing method of the microneedle array as described in any one of thru | or 5.   The method of manufacturing a microneedle array according to any one of claims 1 to 6, wherein the extra-fine columnar body is made of a polyester resin, and the chemical solution is an alkaline aqueous solution.

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