JP2010184102A - Endermic injector device, and needle organizer used for the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an endermic method for surely performing endermism of drugs and chemicals even if a microneedle is short, a needle organizer for use in the method, and an endermic injector device. <P>SOLUTION: The needle organizer 1 provided, on the surface thereof, with a microneedle collective portion 3 where a plurality of microneedles 2 are arranged collectively is applied to a part of skin 18 from which a stratum corneum is stripped, and then drugs and chemicals are injected into the skin from the microneedles 2 in the microneedle collective portion 3. The microneedle collective portion 3 where a plurality of microneedles 2 are arranged collectively and a flat or a convex surface is formed on the surface thereof is formed on the top of the surface, and one or more liquid passing holes 4 are formed to penetrate the needle organizer from the back surface to the front surface or the convex surface. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a transdermal administration device for transdermally administering a drug solution and a needle forming body used in the transdermal administration device.

  Conventionally, injection has been used to administer drugs and drugs that cannot be administered orally (hereinafter referred to as drug solutions). However, the method using injection has a problem that it is highly invasive and painful. there were. In addition, a method of transdermal administration using a patch containing a drug solution has been used, but this method has a problem that it takes time until the drug effect is developed and the types of drug solutions that can be used are limited. .

  In order to solve these problems, techniques called microneedles and microblades have recently been developed.

  The medicinal solution administration method using microneedles (Japanese Patent Laid-Open No. 2006-149818, Patent Document 1) directly administers the medicinal solution to the living cell layer of the epidermis (the epidermis layer below the spinous cell layer), thereby increasing the drug efficacy time. The purpose is to shorten. In addition, it may be used for the purpose of shortening the time of drug efficacy expression of drugs such as insulin and anesthetics as well as physiologically active substances such as DNA, RNA, protein, and peptides, based on the same principle.

  A microneedle is generally a fine needle having a tip diameter of 10 μm, a height of 100 μm, and a skirt diameter of 100 μm, and is a micro structure having a large aspect ratio. Therefore, the medicinal solution administration method using microneedles has an advantage that it does not feel pain when inserted into the human body because it penetrates through the stratum corneum of the skin but does not reach the pain point. Thus, conventional methods using microneedles have focused on the invasion of the body by a syringe, particularly the relief of pain due to needle sticks.

JP 2006-149818 A

  However, although the microneedle is extremely small as described above, in order to administer the drug solution, it must first penetrate the stratum corneum on the surface layer of the epidermis. Therefore, the microneedle needs to have a length (or height) sufficient to penetrate the stratum corneum. In addition, since the stratum corneum is relatively hard and has elasticity, the microneedles need to be thin enough to penetrate the stratum corneum in order to penetrate the stratum corneum. However, if the length and the thinness are requested at the same time, the strength of the microneedle becomes insufficient. Since the microneedle may break or break in the living body when the drug solution is administered, it is necessary to prevent the microneedle from remaining in the body. Thus, it is not easy to produce a microneedle that is long, thin, and has sufficient strength.

  Furthermore, since the conventional dispensing device using microneedles only presses the device against the skin, there is a drawback that a large amount of the chemical solution remains on the skin surface and the chemical solution is not effectively used.

  The present invention has been made to solve the above problems, and an object of the present invention is to provide a transdermal administration device that can reliably administer a drug solution transdermally even when the length of the microneedle is short.

  Another object of the present invention is to provide a transdermal administration device that can effectively use a chemical solution and can reliably transdermally administer a small amount of the chemical solution.

  Another object of the present invention is to provide a needle forming body used in the transdermal administration device.

  In order to solve the above problems, the present invention is characterized by the following.

  Item 1. Press the needle-forming body provided on the surface with a microneedle assembly formed by collecting and arranging a plurality of microneedles against the part of the skin where the stratum corneum is peeled off, and administer the drug solution from the microneedle of the microneedle assembly to the epidermis It is characterized by doing.

  Item 2. The surface is formed in a convex shape, and a microneedle assembly portion formed by collecting and arranging a plurality of microneedles is formed at the top of the surface, and one or more chemical solution dropping holes are formed through the back surface or the convex surface. It is characterized by that.

  Item 3. In item 2, the microneedle is made of a thermoplastic resin and has a skirt diameter of Φ10 to 1000 μm (preferably 50 to 200 μm), a tip diameter of Φ10 to 100 μm, and a height of 10 to 1000 μm (preferably 50 to 100 μm). It is characterized by that.

  Item 4. Item 2 is characterized in that 1 to 10,000 (preferably 100 to 650) microneedles are provided at a pitch of 0.1 to 20 mm (preferably 0.5 to 1 mm) in the microneedle assembly. And

  Item 5. A syringe having a microneedle assembly portion formed by collecting and arranging a plurality of microneedles provided on the surface of the needle formation body, which can be moved up and down within a certain range at the inner lower portion of the cylindrical body, and inserted into the cylindrical body The tip of the needle is integrally fixed to the needle-forming body, the syringe is pumped, and the microneedles below the needle-forming body are pierced into the skin, thereby reaching the microneedle from the syringe through the needle-forming body. Is administered to the living cell layer of the epidermis (the epidermis layer below the spinous cell layer).

  Item 6. In item 5, the needle forming body is integrally fixed to a pedestal provided at a lower part inside the cylindrical body so as to be movable up and down within a certain range, and the tip of the syringe is fixed to the pedestal, Is characterized in that a communication hole for communicating the tip of the syringe with the needle forming body is formed.

  Item 7. In item 6, the cylindrical body or pedestal is formed with an opening that leaves an engagement piece in the middle, and the engagement part that is formed to protrude from the pedestal or cylindrical body is engaged with the engagement piece, The pedestal is biased upward by the elasticity of the engaging piece.

  Item 8. In any one of Items 5 to 7, the lower end opening of the cylindrical body is provided with a skin expanding means for expanding the skin when the cylindrical body is pressed against the skin.

  That is, the present invention is a transdermal administration device having a cylindrical body into which a syringe filled with a medicinal solution is movably inserted, and a needle forming body attached to the distal end portion of the syringe. Connected to the cylindrical body via an elastic member, the needle forming body has a needle forming body main body, and a plurality of microneedles disposed at least in the center of the surface of the needle forming body main body, The needle forming body main body is formed with one or more chemical solution dropping holes running from the back surface side to the front surface side of the main body, thereby achieving the above object.

  In one embodiment, the surface of the needle forming body is formed in a convex shape.

  In one embodiment, the syringe may vibrate relative to the cylindrical body.

  In one embodiment, the elastic member is a substantially cylindrical pedestal fixed to the tip of the syringe, and a needle forming body is fixed to the lower surface of the pedestal, and a drug solution in the syringe is placed on the pedestal on the side of the needle forming body. A communication hole to be sent to is formed.

  In one embodiment, an opening is formed in the cylindrical body, an engagement piece extends from a part of the periphery of the opening to the opening, and the engagement part formed around the base is the engagement. It is engaged with the piece.

  In one embodiment, the lower end opening of the cylindrical body is provided with a skin expanding means for expanding the skin when the cylindrical body is pressed against the skin.

  In one embodiment, the elastic member is a spring or a spring interposed between the syringe and the cylindrical body.

  In addition, another transdermal administration device of the present invention includes a cylindrical body into which a syringe filled with a medical solution is movably inserted, and a needle forming body attached to the tip of the syringe. The needle forming body has a needle forming body main body having a convex surface and a plurality of microneedles arranged at least in the center of the surface of the needle forming main body, One or more liquid passage holes running from the back surface side to the front surface side of the main body are formed through the needle forming body.

  Further, the needle forming body of the present invention has a needle forming body main body whose surface is formed in a convex shape, and a plurality of microneedles arranged at least in the center of the surface of the needle forming main body, One or more chemical solution dropping holes running from the back surface side to the front surface side of the main body are formed through the needle forming body.

  In one embodiment, the microneedle is made of a thermoplastic resin, and the base diameter of the microneedle is Φ10 to 1000 μm, the tip diameter is 10 to 100 μm, and the height is 10 to 1000 μm.

  In one embodiment, the base diameter Φ of the microneedle is 50 to 200 μm, the tip diameter is 10 to 100 μm, and the height is 50 to 100 μm.

  In one embodiment, 1 to 10,000 microneedles are provided at a pitch of 0.1 to 20 mm.

  In one embodiment, 100 to 650 microneedles are provided at a pitch of 0.5 to 1 mm.

  The present invention has the following effects.

  A needle forming body provided with a microneedle assembly portion formed by arranging a plurality of microneedles having a height of 10 to 1000 μm (preferably 50 to 100 μm) on the surface is pressed against the part of the skin where the stratum corneum is peeled off. Since the drug solution is administered from the microneedle to the living cell layer of the epidermis (the epidermis layer below the spinous cell layer), it is not necessary to penetrate the stratum corneum, which was the most problematic for the microneedle. The height can be reduced, and sufficient strength can be ensured even when the diameter of the microneedle is narrow. As a result, it is possible to shorten the time of drug efficacy expression of drugs such as insulin and anesthetics, and physiologically active substances such as DNA, RNA, protein, and peptide.

  Since the stratum corneum is always peeled off and reborn to a new one in a certain cycle, it is easy to peel off this part artificially and without pain. Therefore, the burden on the patient is very light.

  Since the surface provided with the microneedle assembly portion is formed in a convex shape (curvature radius R10 to 100 mm, preferably 30 to 40 mm), when the microneedle assembly portion is pressed against human skin, all or part of Since the microneedles enter evenly without unevenness, efficiency is high. In addition, since one or more liquid passage holes are formed penetrating from the back surface to the surface or convex surface, when the chemical solution is supplied from the back side, the chemical solution moves to the surface side and flows along the convex surface or from the middle of the convex surface. It flows out and moves to the base of the microneedle. Therefore, the medicinal solution can be administered along the microneedle to the living cell layer of the epidermis (the epidermis layer below the spinous cell layer).

  The microneedle is made of a thermoplastic resin and has a base diameter of Φ10 to 1000 μm (preferably 50 to 200 μm), a tip diameter of Φ10 to 100 μm, and a height of 10 to 1000 μm (preferably 50 to 100 μm). It has sufficient strength to enter the living cell layer of the epidermis excluding the stratum corneum as much as possible (the epidermis layer below the spinous cell layer) and has a height of 10 to 1000 μm (preferably 50 to 100 μm) Therefore, the chemical solution can reach the skin in a short time.

  Since the microneedles are provided with 1 to 10,000 (preferably 100 to 650) microneedles at a pitch of 0.1 to 20 mm (preferably 0.5 to 1 mm) in the microneedle assembly portion, It can be supplied to the living cell layer of the epidermis (the epidermis layer below the spinous cell layer).

  A syringe having a microneedle assembly portion formed by collecting and arranging a plurality of microneedles provided on the surface of the needle formation body, which can be moved up and down within a certain range at the inner lower portion of the cylindrical body, and inserted into the cylindrical body The drug solution that has reached the microneedle from the syringe through the needle forming body by integrally fixing the tip of the needle to the needle forming body, pumping the syringe, and piercing the skin with the microneedles below the needle forming body Is administered to the living cell layer of the epidermis (the epidermis layer below the spinous cell layer), so a commercially available syringe can be used, so the cost can be kept low and the administration operation is also easy .

  The needle forming body is integrally fixed to a pedestal provided at the inner lower part of the cylindrical body so as to be movable up and down within a certain range, the tip of the syringe is fixed to the pedestal, and the tip of the syringe is fixed to the pedestal. Since the communication hole for communicating with the needle forming body is formed, the needle forming body can have a simple structure, and the manufacture becomes easy.

  An opening is formed in the cylindrical body or pedestal, leaving an engagement piece in the middle, and an engagement portion formed to project from the pedestal or cylindrical body is engaged with the engagement piece, Since the pedestal is urged upward by elasticity, it is not necessary to provide means for urging the pedestal specially, and the structure can be simplified.

  In the lower end opening of the cylindrical body, when the cylindrical body is pressed against the skin, the skin corresponding to the microneedle is stretched thinly by being spread by the skin expanding means. The drug solution can be administered by entering the living cell layer of the epidermis (the epidermis layer below the spinous cell layer).

  That is, according to the present invention, when the syringe is connected to the cylindrical body via an elastic member, the lower part of the cylindrical body is pressed against the skin surface, and the syringe is pumped (reciprocated) in this state. At the same time, the drug solution in the syringe flows to the surface of the needle forming body through the liquid passage hole of the needle forming body, and at the same time, the plurality of microneedles arranged on the surface of the needle forming body are pierced into the skin. Therefore, even a small amount of drug solution can be reliably transdermally administered. In particular, after peeling off the stratum corneum of the skin using an adhesive tape, etc., as described above, when the lower part of the cylindrical body is pressed against the skin surface and the syringe is pumped, the drug solution that has reached the microneedles is absorbed in the epidermis. Can be administered to a cell layer (epidermal layer below spinous cell layer). Moreover, since it is said structure, since a commercially available syringe can be utilized, cost can be restrained low and administration operation is also easy.

  Furthermore, by providing a skin expansion means that spreads the skin when the cylindrical body is pressed against the skin at the lower end opening of the cylindrical body, the microneedles can more reliably have a living cell layer of the epidermis (below the spinous cell layer). The medicinal solution can be administered.

(a) and (b) are the side view and top view of a needle formation body, respectively. The side view which showed a part of microneedle gathering part simply. The expanded sectional view of a microneedle. The perspective view of a transdermal administration device. Sectional drawing of a transdermal administration device. The expanded sectional view of a part of transdermal administration device. The expanded sectional view of a microneedle.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

  FIGS. 1 (a) and 1 (b) show the principle diagram of a transdermal administration method, in which the reference numeral 1 denotes a needle forming body. On the surface of the needle forming body 1, there is provided a microneedle assembly portion 3 formed by collectively arranging a plurality of microneedles 2 having a height of 10 to 1000 μm (50 to 100 μm).

  The administration site is the skin, but the stratum corneum as much as possible is peeled off beforehand. Since the stratum corneum is always in a natural state, the old one is peeled off to become red and reborn to a new one, so it is easy to peel off this part artificially and without pain. The thickness of the stratum corneum is 10 to 20 μm, but varies slightly depending on the age, sex and the like. The same applies to the elasticity of the stratum corneum.

  Next, as shown in FIG. 1, the needle forming body 1 is a disk-shaped or square member having a convex surface and a diameter or side of 10 to 50 mm (preferably 20 to 40 mm). At the top of the surface, there is provided a microneedle assembly 3 in which a plurality of microneedles 2 are arranged together. The microneedle assembly 3 has a convex surface with a radius of curvature R0 to 100 mm (preferably 10 to 40 mm, more preferably 30 to 40 mm).

  As shown in FIG. 3, the microneedle 2 is formed in a truncated cone shape, the base diameter L1 is Φ10 to 1000 μm (preferably 50 to 200 μm), the needle tip diameter L2 is 10 to 100 μm, and the length (height) H Is 10 to 1000 μm (preferably 50 to 100 μm).

  As shown in FIGS. 2 and 3, the microneedle assembly 3 has 1 to 10,000 (preferably 100) microneedles 2 at a pitch of 0.1 to 20 mm (preferably 0.5 to 1 mm). ˜650) are provided.

  Furthermore, one or more liquid passage holes 4 are formed through the central portion of the needle forming body 1 from the back surface to the front surface or convex surface. The diameter of the hole may be Φ5 mm or less, so that the chemical solution from above does not drip down and oozes out. The position of the liquid passage hole 4 is not limited to the central portion. It may be provided around the microneedle assembly 3 or on a convex surface.

  Further, as shown in FIG. 7 (a), the liquid passage hole 4 may be formed so as to pass through the microneedle 2, or as shown in FIG. 7 (b), the needle does not pass through the microneedle 2. You may form in the position which passes the main body 1a of the formation body 1. FIG. When the liquid passage hole 4 passes through the microneedle 2, it may pass through the tip of the microneedle 2 or may be formed offset from the tip of the microneedle 2. That is, you may form so that the liquid hole 4 may pass through the slope of the microneedle 2. FIG. As shown in FIG. 7C, one microneedle 2 may be provided, or two or more microneedles 2 may be provided.

  The needle forming body 1 may be manufactured by injection molding or imprint molding using a thermoplastic resin such as polycarbonate, polypropylene, ABS resin, or polystyrene.

  In addition, since it is necessary to make many holes of micron order in a metal mold | die, a metal mold | die is manufactured by the cutting process by micron bite, the casting process by a punching tool, electric discharge process, etching process, or electroforming process.

  Next, the needle forming body 1 is used by being attached to the transdermal administration device 5 shown in FIGS.

  In this dosing device, the syringe 7 is inserted from the upper part of the cylindrical body 6, screwed and fixed to the pedestal 8, and after the medical solution is soaked into the microneedle assembly 3, the syringe 7 is pumped to the pedestal 8. The microneedle 2 of the needle-forming body 1 welded at the welded portion is pierced into the skin, and the above-mentioned chemical solution is supplied to the living cell layer of the epidermis (the epidermal layer below the spinous cell layer).

  That is, the needle forming body 1 is integrally fixed to a pedestal 8 that is movably provided at the inner lower portion of the cylindrical body 6. The pedestal 8 is formed in a short cylindrical shape having a cylindrical portion 10 at the center, and a male screw 11 a is formed on the outer end of the cylindrical portion 10. The male screw 11a is formed in such a size that it can be screwed into the female screw 11b inside the outer peripheral edge 12a formed on the outer periphery of the injection needle mounting portion 12 at the tip of the syringe 7.

  The needle forming body 1 is welded and fixed to the lower surface of the base 8. The pedestal-equipped needle-forming body 1 is fitted into a cylindrical body 6. The tubular body 6 is formed with an opening 14 with an engagement piece 13 remaining in the middle, and a rod-like or round engagement portion 15 is formed on the outer side of the upper portion of the pedestal 8. The engaging portion 15 is engaged on the engaging piece 13. As a result, the needle-forming body 1 with a pedestal is urged upward by the elasticity of the engagement piece 13, and is provided so as to be movable up and down within a certain range.

  The cylindrical body 6 is formed with an accommodating portion 16 for accommodating the pedestal-equipped needle forming body 1 so as to be movable up and down, and the upper portion of the accommodating portion 16 is sized so that the cylinder 17 of the syringe 7 can be inserted. Is formed. In addition, an annular edge 20 is formed at the lower end opening of the cylindrical body 6 as a skin enlargement means that spreads the skin when the cylindrical body 6 is pressed against the skin 18.

  When using the skin dosing device 5, first, the piston 19 of the syringe 7 is pulled out, and the drug solution 21 is injected and filled into the cylinder 17. Then, the distal end of the syringe 7 is inserted by inserting the syringe 7 upward into the cylindrical body 6 and screwing the male screw 11a of the cylindrical portion 10 of the base 8 with the female screw 11b of the distal outer peripheral edge 12a of the syringe 7. Is attached to the base 8. Thereby, the said injection needle attachment part 12 and the cylinder part 10 of the base 8 are connected.

  Next, the direction of the dosing device is returned and its tip is applied to the part of the skin 18 where the stratum corneum 18 has been peeled off, and the piston 19 of the syringe 7 is pushed to feed the drug solution 21 from the cylinder 17 through the fluid passage hole 4 and Let it exude over the skin. Then, by pumping the piston 19 of the syringe 7, the drug solution 21 is supplied along the microneedles 2 to the living cell layer of the epidermis (the epidermis layer below the spinous cell layer). Moreover, since the annular edge 20 of the lower end opening of the cylindrical body 6 is pressed against the skin 18 by pumping, the skin 18 is spread and thinly stretched, and the microneedles 2 are more reliably attached to the living cell layer of the epidermis. The medicinal solution 21 can be administered by entering the epidermis layer below the spinous cell layer, and the annular rim 20 can be in close contact with the skin 18, thereby preventing the medicinal solution 21 from flowing out during the administration. .

  When the syringe 7 is pushed to the skin side, the cylindrical body 6 is pressed against the skin 18 by the pressing force, and the engaging portion 15 of the base 8 deflects the engaging piece 13 of the cylindrical body 6 downward. As a result, the microneedle 2 pierces the skin 18.

  When the pressing force is released, the engagement piece 13 returns to its original position due to its inherent elasticity, so that the base 8 also moves upward relative to the cylindrical body 6.

  The pedestal 8 and the needle forming body 1 may be formed integrally instead of separately and the tip of the syringe 7 may be fixed to the needle forming body 1.

  The pedestal-equipped needle forming body 1 may be biased upward by a spring.

  According to the above configuration, since it is not necessary to penetrate through the entire stratum corneum layer 18a, the skin 18 is thinned by the thickness of the peeled stratum corneum, and the skin 18 is pushed and spread at the time of administration, so that the skin 18 is further thinned. Therefore, by setting the height of the microneedles 2 to 10 to 1000 μm (preferably 50 to 100 μm), all or most of the microneedles 2 are living cell layers of the epidermis (epidermal layers below the spinous cell layer). It was confirmed that it reached the state reached. The microneedle assembly 3 is provided with 1 to 10,000 microneedles 2 at 9 pitches of 0.1 to 20 mm (preferably 0.5 to 1 mm). Can be supplied to the cell layer (the epidermal layer below the spinous cell layer).

  Moreover, since the length of the microneedle 2 can be kept low, even if it is not made thick, specifically, the skirt diameter is Φ10 to 1000 μm (preferably 50 to 200 μm), and the tip diameter is 10 to 100 μm. Sufficient strength can be ensured, and it is possible to prevent the microneedles 2 from being broken or broken in the living body at the time of drug solution administration and remaining in the body.

  Furthermore, since the surface of the needle forming body 1 is formed in a convex shape, when pressed against the skin, the microneedle assembly part 3 is intensively and strongly pressed, and the pressure is not dispersed. Therefore, most of the microneedles 2 are inserted into the skin, and the drug solution 21 can be efficiently supplied into the skin 18.

  As a result, it is possible to shorten the drug expression time of drugs such as insulin and anesthetics, and physiologically active substances such as DNA, RNA, proteins, and peptides.

  In addition, there is no pain in the exfoliation (peeling) treatment of the stratum corneum, and even if the microneedle 2 is stabbed, the pain point is not reached, so the load on the patient is very light.

  In addition, the needle forming body 1 may not be circular, but may be rectangular, oval, elliptical or the like, and the needle assembly portion 3 that is a skin contact surface is not limited to a convex surface. It may be formed in a planar shape. Further, the shape of the microneedle 2 is not limited to that described above. Furthermore, the needle portion may not be in the shape of a truncated cone, but may be a triangular frustum, a quadrangular frustum, or the like, and a groove for passing a drug solution to be administered in the height direction may be cut. Furthermore, there may be a through hole from the vicinity of the tip of the needle portion to the back surface of the needle forming body 1.

  Hereinafter, the present invention will be described in more detail.

  The transdermal administration device of the present invention has a cylindrical body 6 into which a syringe 7 filled with a drug solution is movably inserted, and a needle forming body 1 attached to the tip of the syringe 7.

  A flange is formed at the upper end of the tubular body 6, a housing part 16 having a slightly larger diameter is formed at the lower part of the tubular body 6, and a skin expansion means 20 is formed at the lower end of the housing part 16. Are integrally provided with an inclination.

  The needle forming body 1 is connected to the tip of a syringe 7 via a base 8. This needle-forming body 1 has a substantially lens-shaped needle-forming body main body having a convex surface and a plurality of microneedles 2 arranged at least at the center of the surface of the needle-forming main body. The microneedles 2 may be arranged on the entire surface of the main body excluding the peripheral edge of the needle forming body.

  One or more chemical solution dropping holes 4 running from the back surface side to the front surface side of the main body are formed through the central portion of the needle forming body.

  The pedestal 8 is formed in a substantially cylindrical shape, and includes a cylindrical portion 10, an outer cylinder, an annular coupling body that couples the cylindrical portion 10 and the outer cylinder, and an engaging portion 15 that extends outward from the outer cylinder. And having. A communication hole is formed in the cylindrical portion 10. The needle forming body 1 is fixed to the lower surface of the connecting body, and the chemical solution administration hole 4 and the communication hole formed in the needle forming body 1 are continuous.

  As shown in FIG. 4, a male screw 1a is formed at the end of the outer cylinder, and the female screw 11b formed at the tip of the syringe 7 as described above is screwed into the male screw 11a.

  An opening 14 is formed at a position facing the accommodating portion 16 formed at the distal end portion of the syringe 7. An engagement piece 13 extends in a horizontal direction from a part of the periphery of the opening 14. And the engaging part 15 of the said base 8 is inserted in the opening part 14 so that this engaging piece 13 may be engaged. Therefore, the engaging piece 13 can be elastically deformed in the vertical direction, so that the pedestal 8 can move in the vertical direction within the accommodating portion 16.

  When the lower part of the cylindrical body 6 is applied to the skin surface and the syringe 7 is pressed against the skin, the pedestal 8 and the needle forming body 1 provided at the lower end thereof move downward, and the microneedle 2 enters the skin. When the pressing force to the syringe 7 is released, the syringe 7 is pushed upward by the restoring force of the engagement piece 13, and the microneedle 2 is removed from the skin. By repeating (pumping) this operation, the microneedle 2 is pierced into the skin or removed from the skin.

EXAMPLES Hereinafter, the present invention will be specifically described with reference to examples, but the present invention is not limited to these examples.
Example 1
A microneedle forming body 1 was prepared by arranging 121 microneedles 2 made of polycarbonate having a frustoconical shape having a height of 100 μm, a base diameter of Φ200 μm, and a tip diameter of 20 μm on a base portion having an outer diameter of Φ20 mm and a wall thickness of 1 mm. .

  After the adhesive sheet was attached to the skin, the stratum corneum layer of the skin was removed by peeling the adhesive sheet from the skin. This removed about 80 percent of the stratum corneum of the skin.

  What contained 1, 10, and 20 mg of histamine (product made from sigma) per 1 g of hydrophilic ointment was apply | coated to skin.

Thereafter, when the microneedles of the microneedle forming body were attached to the skin surface and administered through the skin, urticaria occurred. Thus, it was verified that the needle of the microneedle 2 surely passed through the stratum corneum and reached the living cell layer (skin layer below the spinous cell layer) of the skin.
(Example 2)
121 micronized polycarbonate needles 2 with a height of 100 μm, a skirt diameter of Φ70 μm, and a tip diameter of 10 μm are arranged at a pitch of 1 mm at the base of an outer diameter of Φ20 mm and a convex shape (thickness up to the convex top is 4 mm and R39 mm). Thus, a microneedle forming body 1 was prepared.

  After the adhesive sheet was attached to the skin, the stratum corneum layer of the skin was removed by peeling the adhesive sheet from the skin. This removed about 80 percent of the stratum corneum of the skin.

  What contained 1, 10 and 20 mg of histamine (manufactured by Sigma) per 1 g of hydrophilic ointment was applied to the skin.

Thereafter, when the microneedles of the microneedle forming body were attached to the skin surface and administered through the skin, urticaria occurred. Thus, it was verified that the needle of the microneedle 2 surely passed through the stratum corneum and reached the living cell layer (skin layer below the spinous cell layer) of the skin.
(Example 3)
After affixing the adhesive sheet to the skin, the stratum corneum of the skin was removed by peeling the adhesive sheet from the skin. This removed about 80 percent of the stratum corneum of the skin.

  The microneedle forming body used in Example 1 was pressed against the skin, and the microneedle forming body was peeled off.

  Thereafter, 1 mg of two sigma protein peroxidases and ovalbumin (OVA) dissolved in physiological saline was applied to the skin. When the skin was observed after 24 hours, the presence of protein peroxidase and OVA was found in the living cell layer of the skin below the stratum corneum (the epidermis layer below the spinous cell layer), and pores by microneedles penetrating the stratum corneum Confirmed to be open.

  When the cross section of the skin was observed with a hematoxylin / eosin stained section under an optical microscope, it was found that the needle of the microneedle 2 had reached the living cell layer of the epidermis (the epidermal layer below the spinous cell layer). When the skin was observed by continuous sections, it was found that a hole was opened by the needle of the microneedle 2.

DESCRIPTION OF SYMBOLS 1 Needle formation body 1a Needle formation body main body 2 Microneedle 3 Needle assembly part 4 Fluid passage hole 5 Percutaneous administration apparatus 18 Skin

Claims (13)

A transdermal administration device having a cylindrical body into which a syringe filled with a medical solution is movably inserted, and a needle forming body attached to the tip of the syringe,
The syringe is connected to the cylindrical body via an elastic member,
The needle forming body has a needle forming body main body and a plurality of microneedles arranged at least at the center of the surface of the needle forming body main body, and the needle forming body main body is a surface from the back side of the main body. A percutaneous administration device in which one or more drug solution dropping holes running to the side are formed. The transdermal administration device according to claim 1, wherein a surface of the needle forming body is formed in a convex shape. The transdermal administration device according to claim 1, wherein the syringe can vibrate with respect to the cylindrical body. The elastic member is a substantially cylindrical pedestal fixed to the distal end portion of the syringe, and a needle forming body is fixed to the lower surface of the pedestal, and a communication hole through which the drug solution in the syringe is sent to the needle forming body side The transdermal administration device according to claim 1, wherein An opening is formed in the cylindrical body, an engagement piece extends from a part of the periphery of the opening to the opening, and an engagement part formed around the base is engaged with the engagement piece. The transdermal administration device according to claim 4. The transdermal administration device according to any one of claims 1 to 5, wherein a skin expanding means is provided at a lower end opening of the cylindrical body to expand the skin when the cylindrical body is pressed against the skin. The transdermal administration device according to claim 1, wherein the elastic member is a spring or a spring interposed between the syringe and the cylindrical body. A transdermal administration device having a cylindrical body into which a syringe filled with a medical solution is movably inserted, and a needle forming body attached to the tip of the syringe,
The needle forming body includes a needle forming body main body having a convex surface and a plurality of microneedles disposed at least in the center of the surface of the needle forming body main body. A percutaneous administration device in which one or more liquid passage holes running from the back side to the front side of the main body are formed. A needle-forming body main body having a convex surface and a plurality of microneedles arranged at least in the center of the surface of the needle-forming main body. A needle forming body in which one or more chemical solution dropping holes running from the side to the surface side are formed therethrough. The needle forming body according to claim 9, wherein the microneedle is made of a thermoplastic resin, and the base diameter of the microneedle is Φ10 to 1000 µm, the tip diameter is 10 to 100 µm, and the height is 10 to 1000 µm. The needle forming body according to claim 10, wherein the base diameter of the microneedle is Φ50 to 200 µm, the tip diameter is 10 to 100 µm, and the height is 50 to 100 µm. The needle forming body according to claim 10, wherein 1 to 10,000 microneedles are provided at a pitch of 0.1 to 20 mm. The needle forming body according to claim 10, wherein 100 to 650 microneedles are provided at a pitch of 0.5 to 1 mm.

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