JP2009178531A - Carbohydrate microneedle, and method and device for manufacturing the same - Google Patents
Carbohydrate microneedle, and method and device for manufacturing the same Download PDFInfo
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- JP2009178531A JP2009178531A JP2008048703A JP2008048703A JP2009178531A JP 2009178531 A JP2009178531 A JP 2009178531A JP 2008048703 A JP2008048703 A JP 2008048703A JP 2008048703 A JP2008048703 A JP 2008048703A JP 2009178531 A JP2009178531 A JP 2009178531A
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- needle
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- sugar
- fine needle
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
Landscapes
- Health & Medical Sciences (AREA)
- Dermatology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Medical Informatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Surgical Instruments (AREA)
Abstract
Description
本発明は、皮膚の治療及び改善、更には生体改質等を目的として、皮膚内に医薬剤、栄養補助剤、化粧材、生体物質等を微細糖質針により挿入する経皮系投薬、投与技術に関し、また、美容のために人の皮膚内に化粧材を微細糖質針の挿入により行う肌修飾技術に関するものである。 The present invention is a transdermal dosage / administration in which a pharmaceutical agent, nutritional supplement, cosmetic material, biological material, etc. is inserted into the skin with a fine sugar needle for the purpose of treatment and improvement of the skin, and further biomodification, etc. The present invention also relates to a skin modification technique in which a cosmetic material is inserted into a human skin for beauty by inserting a fine sugar needle.
従来、経皮系投薬を目的として微細針の研究開発が盛んに行われ、主に微細針の素材として金属やプラスチックのような工業材料を使うものが大半であったが、近年においては実用性が高く、生体に馴染む糖質素材の微細針、すなわち微細糖質針が製品化される段階へと進展しつつある。 Conventionally, research and development of microneedles has been actively conducted for the purpose of transdermal administration, and most of them used industrial materials such as metals and plastics as the material of microneedles. Therefore, the fine needles of carbohydrate materials that are high and adaptable to living bodies, that is, fine sugar needles are being developed.
微細糖質針への薬剤等の保持方法としては、薬剤等を微細針の素材である糖質に混在させる方法や、微細糖質針の表面に薬剤等を付着させる方法が採用されてきた。しかしながら、単一の微細針における上記の混在、付着の方法では、十分な医薬剤投与量を確保することが困難であった。 As a method for retaining a drug or the like on the fine sugar needle, a method of mixing the drug or the like with a sugar as a material of the fine needle and a method of attaching the drug or the like to the surface of the fine sugar needle have been adopted. However, it has been difficult to ensure a sufficient dose of the pharmaceutical agent by the above-described mixing and adhesion method using a single fine needle.
そこで、十分な医薬剤投与量を確保するため、薬材等を混在、付着させた上記微細針をマイクロパイル化した微細針、剣山形状化した微細針、更には一列に微細針を並べて櫛形状化した微細針が採用され、その製法としては射出成形法が適用されてきたが、薬剤等が微細針以外に基板にも含有されるという無駄が発生し、実用上問題であった。 Therefore, in order to secure a sufficient amount of pharmaceutical agent, the above-mentioned fine needles mixed and adhering to medicinal materials are micropile-shaped microneedles, sword-shaped microneedles, and comb-shaped with fine needles arranged in a row Fine needles have been adopted, and an injection molding method has been applied as a manufacturing method thereof. However, there has been a waste in that a drug or the like is contained in the substrate in addition to the fine needles, which is a problem in practical use.
上記のマイクロパイル化した皮膚用微細針の開発事例としては、糖質のマルトースが主成分の微細針集合体である、機能性マイクロパイル及びその製造方法(例えば、特許文献1参照)があるが、これは皮膚表面又は皮膚角質層への機能付与の際に、無痛状態にて皮膚機能再生に向けての簡便性、安全性を大きく向上させたものである。
従来の薬剤等を混在させる微細糖質針においては、針を設ける基板も糖質で針と連係したものであるため、基板にも薬剤等が無駄に入り込むこととなる。そこで、針と基板を分離すべく、糖質とは異なる素材を基板に使用し、薬剤等が無駄に基板へ混入することを防ぐことができるが、その際、針部と基板の接着が脆弱になり、針部を皮膚に挿入させる際、針部がその脆弱な接着部位近傍で折れて皮膚に刺さらずに実用性が極度に落ちるという点が課題となっていた。このため、最も実用性の高い形状として一列に並んだ櫛形状の微細糖質針においてさえ、皮膚に挿入する時には折れるほど脆く、実用性に耐えるものではなかった。ちなみに、従来の櫛形状の微細糖質針の外形及びその断面を図1及び図2に示すが、ここでは微細糖質針1の材質(糖質)と基板2の材質が異なり、微細糖質針1と基板2とは接着状態にあり、その接着部位3が脆くなり、皮膚挿入時に微細針が接着部位3近傍で非常に折れ易くなるという欠点がある。 In a conventional fine sugar needle in which a drug or the like is mixed, the substrate on which the needle is provided is also sugar and linked to the needle, so that the drug or the like enters the substrate wastefully. Therefore, in order to separate the needle and the substrate, it is possible to use a material different from carbohydrates for the substrate, and to prevent drugs and the like from being mixed into the substrate unnecessarily, but in this case, the adhesion between the needle part and the substrate is fragile. Thus, when the needle part is inserted into the skin, the problem is that the needle part breaks in the vicinity of the fragile adhesion site and does not pierce the skin, and the practicality is extremely reduced. For this reason, even the comb-shaped fine saccharide needles arranged in a row as the most practical shape are so brittle that they are broken when inserted into the skin, and the practicality cannot be endured. Incidentally, the external shape and cross section of a conventional comb-shaped fine sugar needle are shown in FIGS. 1 and 2, but here the material of the fine sugar needle 1 (sugar) and the material of the
また、従来の微細糖質針においては、微細針部と基板部を分けて微細糖質針を製作する場合、微細針上面と基板上面とに段差が生じることに起因して、微細針の根元において十分に平滑な面の成形ができないため、微細針の根元の強度が低下し、その脆弱な根元近傍で微細針が非常に折れ易くなり、皮膚に刺さらないという点が課題であった。 Further, in the conventional fine sugar needle, when the fine sugar needle is manufactured by dividing the fine needle portion and the substrate portion, there is a step between the upper surface of the fine needle and the upper surface of the substrate. However, since a sufficiently smooth surface cannot be formed, the strength of the root of the fine needle is lowered, and the fine needle is very easy to break in the vicinity of the fragile root, and the problem is that it does not pierce the skin.
尚、従来、美容のための微細糖質針を皮膚角質層に限定させて挿入するためには、微細針の長さを角質層の厚さに等しい程度に十分微小にする必要があった。しかしながら、このような微細針では、皮膚の角質層内に挿入できる部分の体積が小さ過ぎるため、糖質からなる針部に混在させた薬剤だけでは、十分な投与量が確保できなかった。そこで、この点を解決するべく、微細針に薬剤や化粧材を混在させた上で、更には薬剤や化粧材を断片(チップ)化し、これを微細針に搭載又は内包させたものが開発されてきたが、微細針が微小のため、上記の薬剤チップや化粧材チップも微小化され、その分だけ薬剤等の皮膚への投与量が制約されるという点が課題となっていた。ちなみに、従来の薬剤チップを搭載した微細糖質針の断面を図3に示すが、ここでは微細糖質針1の上面にのみ薬剤チップ4が搭載されるので、薬剤チップ4の大きさが制限され、これに応じて皮膚への薬剤投与量が制約を受けることとなる。 Conventionally, in order to insert a fine sugar needle for cosmetic purposes only in the skin stratum corneum, it has been necessary to make the length of the fine needle sufficiently small to be equal to the thickness of the stratum corneum. However, with such a fine needle, since the volume of the portion that can be inserted into the stratum corneum of the skin is too small, a sufficient dose cannot be ensured only with the drug mixed in the needle portion made of sugar. Therefore, in order to solve this problem, a drug or cosmetic material mixed with fine needles, and further a drug or cosmetic material fragmented (chip), which is mounted or encapsulated in a fine needle has been developed. However, since the fine needles are very small, the above-mentioned drug chips and cosmetic material chips are also miniaturized, and the dose of drugs and the like to the skin is limited accordingly. Incidentally, FIG. 3 shows a cross section of a conventional fine sugar needle loaded with a drug chip. Here, since the
更には、糖質のような加熱溶解を必要とする素材で微細針を成形する際、混在させる薬剤、化粧材等によっては、成形時の加熱に耐えることができない薬剤等もあり、薬剤等の種類が限定されるという点が課題であった。 Furthermore, when molding fine needles with materials that require heating and dissolution, such as carbohydrates, there are drugs that cannot withstand the heating during molding depending on the drugs and cosmetics to be mixed, such as drugs. The problem was that the types were limited.
本発明は、前述の課題を解決するための手段として、
(1)針先端部から針底面部までの垂線長が100μmから2mm、針底面部横幅が20μmから1mm、針底面部縦幅が20μmから1mmの糖質からなる微細針を、前記糖質とは異なる素材からなる基板の上面側端部に溶接された前記糖質からなる微細針取付け代の側面に、1個又は櫛形状に複数個配列した構造であることを特徴とする微細糖質針、並びに、
(2)針先端部から針底面部までの垂線長が100μmから2mm、針底面部横幅が20μmから1mm、針底面部縦幅が20μmから1mmの糖質からなる微細針を、前記糖質とは異なる素材からなる基板の上面食い込み部に溶接された前記糖質からなる微細針取付け代の側面に、1個又は櫛形状に複数個配列し、かつ前記微細針上面と前記微細針取付け代上面とが連続して平滑した構造であることを特徴とする微細糖質針、並びに、
(3)請求項2記載の微細糖質針において、前記微細針取付け代上面と前記基板上面とが連続して平滑した構造であることを特徴とする微細糖質針、並びに、
(4)前記(2)又は(3)記載の微細糖質針において、前記微細糖質針が同方向を指すように前記基板を複数個重ねた剣山状構造であることを特徴とする微細糖質針、並びに、
(5)前記基板が複数層からなることを特徴とする前記(1)から(4)いずれかの微細糖質針、並びに、
(6)前記基板の素材が、プラスチック、木、金属、紙、多糖材、ゼラチン、蛋白固形物、から選ばれる1又は2以上であることを特徴とする前記(1)から(5)いずれかの微細糖質針、並びに、
(7)前記糖質がマルトースであり、前記基板の素材が紙であることを特徴とする前記(1)から(5)いずれかの微細糖質針、並びに、
(8)前記微細針上面と連続平滑面をなす前記微細針取付け代上面の両上面にグルコースを被覆し、前記グルコース被覆面上に薬剤を搭載したことを特徴とする前記(1)から(7)いずれかの微細糖質針、並びに、
(9)前記微細針内部に薬剤を含有したことを特徴とする前記(1)から(7)いずれかの微細糖質針、並びに、
(10)前記薬剤が、アスコルビン酸ナトリウム、アスコルビン酸マグネシウム、ヒアルロン酸、コラーゲン、ヒトIgG、ヒトIgM、抗体医薬、核酸医薬、色素、ビタミンA、ビタミン類、インスリン、ホルモン、から選ばれる1又は2以上であることを特徴とする前記(8)又は(9)記載の微細糖質針、並びに、
(11)前記微細針上面と連続平滑面をなす前記微細針取付け代上面の両上面にグルコースを被覆し、前記グルコース被覆面上に生体物質を搭載したことを特徴とする前記(1)から(7)いずれかの微細糖質針、並びに、
(12)前記微細針内部に生体物質を内包したことを特徴とする前記(1)から(7)いずれかの微細糖質針、並びに、
(13)前記生体物質が、DNA、アミノ酸、蛋白質、ヒトIgG抗体、ワクチン、細胞内微小体、細胞、微生物、から選ばれる1又は2以上であることを特徴とする前記(11)又は(12)の微細糖質針、並びに、
(14)微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の前記微細針上面と、前記基板上面側端部又は前記基板上面食い込み部に設けた前記微細針取付け代上面と、前記基板上面とを平滑面とするべく、前記微細針上面と前記微細針取付け代上面と前記基板上面とを加圧して平坦化させる方法を用いることを特徴とする微細糖質針の製造方法、並びに、
(15)微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の前記微細針上面と、前記基板上面側端部又は前記基板上面食い込み部に設けた前記微細針取付け代上面と、前記基板上面とを平滑面とするべく、前記微細針上面と前記微細針取付け代上面と前記基板上面とを加圧して平坦化させる方法に供する加圧機構を有することを特徴とする微細糖質針の製造装置、並びに、
(16)微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の前記微細針上面と、前記基板上面側端部又は前記基板上面食い込み部に設けた前記微細針取付け代上面と、前記基板上面とを平滑面とするべく、前記微細針上面と前記微細針取付け代上面と前記基板上面とを掃引して平坦化させる方法を用いることを特徴とする微細糖質針の製造方法、並びに、
(17)微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の前記微細針上面と、前記基板上面側端部又は前記基板上面食い込み部に設けた前記微細針取付け代上面と、前記基板上面とを平滑面とするべく、前記微細針上面と前記微細針取付け代上面と前記基板上面とを掃引して平坦化させる方法に供する掃引機構を有することを特徴とする微細糖質針の製造装置、並びに、
(18)微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の前記微細針上面と、前記基板上面側端部又は前記基板上面食い込み部に設けた前記微細針取付け代上面と、前記基板上面とを平滑面とするべく、前記微細針上面と前記微細針取付け代上面と前記基板上面とを回転ローラにより加圧して平坦化させる方法を用いることを特徴とする微細糖質針の製造方法、並びに、
(19)微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の前記微細針上面と、前記基板上面側端部又は前記基板上面食い込み部に設けた前記微細針取付け代上面と、前記基板上面とを平滑面とするべく、前記微細針上面と前記微細針取付け代上面と前記基板上面とを回転ローラにより加圧して平坦化させる方法に供する回転ローラを有することを特徴とする微細糖質針の製造装置、並びに、
(20)微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の前記微細針上面と、前記基板上面側端部又は前記基板上面食い込み部に設けた前記微細針取付け代上面と、前記基板上面とを平滑面とするべく、前記微細針上面と前記微細針取付け代上面と前記基板上面とを可動シートにより掃引して平坦化させる方法を用いることを特徴とする微細糖質針の製造方法、並びに、
(21)微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の前記微細針上面と、前記基板上面側端部又は前記基板上面食い込み部に設けた前記微細針取付け代上面と、前記基板上面とを平滑面とするべく、前記微細針上面と前記微細針取付け代上面と前記基板上面とを可動シートにより掃引して平坦化させる方法に供する可動シートを有することを特徴とする微細糖質針の製造装置、としたものである。As a means for solving the above-mentioned problems, the present invention provides:
(1) A fine needle made of a saccharide having a perpendicular length from the needle tip to the needle bottom of 100 μm to 2 mm, a needle bottom width of 20 μm to 1 mm, and a needle bottom length of 20 μm to 1 mm is Is a structure in which one or a plurality of combs are arranged on the side surface of the sugar fine needle mounting allowance welded to the upper surface side end of a substrate made of a different material. As well as
(2) A fine needle composed of a saccharide having a perpendicular length from the needle tip portion to the needle bottom portion of 100 μm to 2 mm, a needle bottom portion lateral width of 20 μm to 1 mm, and a needle bottom portion vertical width of 20 μm to 1 mm, Are arranged on the side surface of the sugar fine needle attachment allowance welded to the upper bite portion of the substrate made of a different material, and arranged in one or a plurality of comb shapes, and the fine needle upper surface and the fine needle attachment allowance upper surface And a fine sugar needle characterized by having a continuously smooth structure, and
(3) The fine sugar needle according to
(4) The fine sugar needle according to (2) or (3), wherein the fine sugar needle has a sword mountain-like structure in which a plurality of the substrates are stacked so that the fine sugar needle points in the same direction. Quality needles, and
(5) The fine sugar needle according to any one of (1) to (4), wherein the substrate comprises a plurality of layers, and
(6) Any one of (1) to (5) above, wherein the material of the substrate is one or more selected from plastic, wood, metal, paper, polysaccharide material, gelatin and protein solids Fine sugar needles, and
(7) The fine sugar needle according to any one of (1) to (5), wherein the sugar is maltose, and the material of the substrate is paper, and
(8) The above (1) to (7), wherein glucose is coated on both upper surfaces of the fine needle mounting allowance surface that forms a continuous smooth surface with the upper surface of the fine needle, and a drug is mounted on the glucose-coated surface. ) Any fine sugar needle, and
(9) The fine sugar needle according to any one of (1) to (7), wherein a drug is contained in the fine needle, and
(10) 1 or 2 wherein the drug is selected from sodium ascorbate, magnesium ascorbate, hyaluronic acid, collagen, human IgG, human IgM, antibody drug, nucleic acid drug, dye, vitamin A, vitamins, insulin, hormone The fine sugar needle according to (8) or (9) above, and
(11) From (1) to (1), wherein glucose is coated on both upper surfaces of the fine needle mounting allowance surface forming a continuous smooth surface with the fine needle upper surface, and a biological material is mounted on the glucose coated surface. 7) any fine sugar needle, and
(12) The fine sugar needle according to any one of (1) to (7), wherein a biological material is encapsulated in the fine needle, and
(13) The biological material is one or more selected from DNA, amino acid, protein, human IgG antibody, vaccine, intracellular microbody, cell, and microorganism, (11) or (12) ) Fine sugar needles, and
(14) In a method of independently using a mold dedicated to a fine needle separated from a substrate when producing a fine sugar needle, the upper surface of the fine needle after the mold separation and the upper end side of the substrate upper surface or the upper surface of the substrate A method of pressing and flattening the upper surface of the fine needle, the upper surface of the fine needle attachment, and the upper surface of the substrate is used so that the upper surface of the fine needle attachment margin provided in the biting portion and the upper surface of the substrate are smooth. A method for producing a fine saccharide needle, and
(15) In a method of independently using a mold dedicated to a fine needle separated from a substrate when manufacturing a fine sugar needle, the upper surface of the fine needle after separation of the mold and the upper surface side end of the substrate or the upper surface of the substrate A method for pressurizing and flattening the upper surface of the fine needle, the upper surface of the fine needle attachment, and the upper surface of the substrate so that the upper surface of the fine needle attachment margin provided on the biting portion and the upper surface of the substrate are smooth surfaces. Fine sugar needle manufacturing apparatus characterized by having a pressurizing mechanism, and
(16) In a method of independently using a mold dedicated to a fine needle separated from a substrate when manufacturing a fine sugar needle, the upper surface of the fine needle after separation of the mold and the upper end of the substrate upper surface or the upper surface of the substrate A method of sweeping and flattening the upper surface of the fine needle, the upper surface of the fine needle attachment, and the upper surface of the substrate is used so that the upper surface of the fine needle attachment margin provided on the biting portion and the upper surface of the substrate are smooth. A method for producing a fine saccharide needle, and
(17) In a method of independently using a mold dedicated to a fine needle separated from a substrate when manufacturing a fine sugar needle, the upper surface of the fine needle after the mold separation and the upper end of the substrate upper surface or the upper surface of the substrate A method for sweeping and flattening the upper surface of the fine needle, the upper surface of the fine needle attachment, and the upper surface of the substrate so as to make the upper surface of the fine needle attachment margin provided in the biting portion and the upper surface of the substrate smooth. Fine sugar needle manufacturing apparatus characterized by having a sweep mechanism, and
(18) In a method of independently using a mold dedicated to a fine needle separated from a substrate when manufacturing a fine sugar needle, the upper surface of the fine needle after the mold separation and the upper end of the substrate upper surface or the upper surface of the substrate The upper surface of the fine needle, the upper surface of the fine needle attachment, and the upper surface of the substrate are flattened by applying pressure to the upper surface of the fine needle, the upper surface of the fine needle, and the upper surface of the substrate so as to make the upper surface of the fine needle attachment surface and the upper surface of the substrate smooth. A method for producing a fine sugar needle characterized by using the method, and
(19) In a method of independently using a mold dedicated to a fine needle separated from a substrate when manufacturing a fine sugar needle, the upper surface of the fine needle after separation of the mold, the upper surface side end of the substrate, or the upper surface of the substrate The upper surface of the fine needle, the upper surface of the fine needle attachment, and the upper surface of the substrate are flattened by applying pressure to the upper surface of the fine needle, the upper surface of the fine needle, and the upper surface of the substrate so as to make the upper surface of the fine needle attachment surface and the upper surface of the substrate smooth. A fine sugar needle manufacturing apparatus characterized by having a rotating roller for use in the method, and
(20) In a method of independently using a mold dedicated to a fine needle separated from a substrate when manufacturing a fine sugar needle, the upper surface of the fine needle after the mold separation and the upper surface side end of the substrate or the upper surface of the substrate The upper surface of the fine needle, the upper surface of the fine needle, and the upper surface of the substrate are swept and flattened by a movable sheet so that the upper surface of the fine needle mounting allowance provided on the biting portion and the upper surface of the substrate are smooth. A method for producing a fine sugar needle characterized by using the method, and
(21) In a method of independently using a mold dedicated to a fine needle separated from a substrate when producing a fine sugar needle, the upper surface of the fine needle after the mold separation and the upper end of the substrate upper surface or the upper surface of the substrate The upper surface of the fine needle, the upper surface of the fine needle, and the upper surface of the substrate are swept and flattened by a movable sheet so that the upper surface of the fine needle mounting allowance provided on the biting portion and the upper surface of the substrate are smooth. An apparatus for producing a fine carbohydrate needle, characterized by having a movable sheet for use in the method.
本発明の微細糖質針においては、微細針と同素材の糖質からなる微細針取付け代の側面に、1個の微細針を配列し、又はその微細針を櫛形状に複数個配列し、その微細針取付け代が微細針の糖質と異なる素材からなる基板の上面側端部に溶接された構造とすることにより、微細針とこの溶接による微細針取付け代が同素材の糖質からなる一体構造となるために、微細針を皮膚へ挿入させる際、微細針は折れ難く、皮膚へ刺さり易くなることが可能となった。この溶接による取付け代を有する微細糖質針の一例の外形を図4に示すが、ここでは、微細針5と基板2の上面側端部に溶接された微細針取付け代6とが一体構造となっており、微細針を皮膚へ挿入させる際、微細針は折れ難く、皮膚へ刺さり易くなる。その後、皮膚内に刺さった微細針は皮膚内で容易に折れ、皮膚内に残留した微細針自体は溶解するので安全である。ちなみに、図4は、微細針5の上面と微細針取付け代6の上面とが連続した平滑面となっている場合を示すが、これらの広い平滑面上に薬剤、化粧材、生体物質を多量に搭載することが可能である。尚、上記微細糖質針の別例を図5に示すが、ここでは微細針5の上面と微細針取付け代6の上面とは連続した平滑面をなしておらず、この狭い微細針上面に薬剤、栄養補助剤、化粧材、生体物質を多量に搭載することは困難であるが、この場合でも薬剤等を微細針内部に含有させることは可能である。 In the fine sugar needle of the present invention, one fine needle is arranged on the side surface of the fine needle mounting allowance made of the same material as the fine needle, or a plurality of the fine needles are arranged in a comb shape, By adopting a structure in which the fine needle mounting allowance is welded to the upper surface side end portion of the substrate made of a material different from the sugar of the fine needle, the fine needle and the fine needle mounting allowance by this welding are made of the same material sugar. Due to the integral structure, when the fine needle is inserted into the skin, the fine needle is difficult to break and can be easily pierced into the skin. FIG. 4 shows an outline of an example of a fine sugar needle having an attachment allowance by welding. Here, the
本発明の微細糖質針においては、微細針と同素材の糖質からなる微細針取付け代の側面に1個の微細針を配列し、又はその微細針を櫛形状に複数個配列し、その微細針取付け代が微細針の糖質と異なる素材からなる基板の上面食い込み部に溶接され、かつその微細針上面とこの微細針取付け代上面とが連続して平滑した構造とすることにより、微細針と食い込みによる微細針取付け代が同素材の糖質からなる一体構造となるために微細針を折れ難くすることが可能となった。これにより、微細針を皮膚へ挿入させる際、微細針は折れ難く、皮膚へ刺さり易くなることが可能となった。この食い込みによる取付け代を有する微細糖質針の一例の外形及びその断面を図6、図7に示すが、この図では共通の食い込み代を有する櫛形状の微細糖質針を示す。ここでは、微細針5と基板2の上面食い込み部に溶接された微細針取付け代7とが一体構造となっており、微細針5を皮膚へ挿入させる際、微細針5は折れ難く、皮膚へ刺さり易くなる。その後、皮膚内に刺さった微細針は皮膚内で容易に折れ、皮膚内に残留した微細針自体は溶解するので安全である。また、本発明において、微細針部位とは、図6に示された波線状円内で囲まれた微細針の部位を意味し、本発明の微細糖質針とは、この微細針部位と微細針取付け代部位と基板部位から構成される。尚、共通の食い込み代を有しない微細糖質針の一例の外形を図8、図9に示すが、ここでは微細針5の上面と微細針取付け代7の上面とが連続した平滑面となっているので、これらの広い平滑面上に薬剤、化粧材、生体物質を多量に搭載することが可能である。また、異なる形状の食い込み代を有する微細糖質針の各種一例の断面を図10、図11、図12、図13に示す。これら各種形状の微細糖質針は、微細針の根元近傍や、微細針取付け代と基板との接合部位近傍の強度を高く保持したい場合、製造コストを下げたい場合等の目的に応じて、これらの形状を使い分けすることが可能である。すなわち、例えば図13のような階段状の微細針取付け代の場合、図10に示す場合に比べて、基板との接触面積はさらに増加するため、糖質の溶接による基板との接着強度は大きくなる。 In the fine saccharide needle of the present invention, one fine needle is arranged on the side surface of the fine needle attachment allowance made of the same material as the fine needle, or a plurality of the fine needles are arranged in a comb shape, The fine needle mounting allowance is welded to the top biting portion of the substrate made of a material different from the sugar of the fine needle, and the fine needle upper surface and the fine needle attaching allowance upper surface are continuously smoothed to achieve a fine structure. The fine needle mounting allowance by the needle and bite becomes an integral structure made of the same material sugar, making it possible to make the fine needle difficult to break. As a result, when the fine needle is inserted into the skin, the fine needle is difficult to break and can be easily pierced into the skin. FIG. 6 and FIG. 7 show an outer shape and a cross section of an example of a fine sugar needle having an attachment allowance due to this biting, and this figure shows a comb-shaped fine sugar needle having a common bite allowance. Here, the
また、本発明の微細糖質針においては、更に、微細取付け代上面と基板上面をも共に段差なく一致させるように平坦化して滑らかに繋げば、微細針と取付け代とが一体化してさらに強固になり、ほとんどクラックが入り難く、皮膚挿入の際に微細針が折れず、皮膚に刺さり易くなることが可能となった。 Further, in the fine sugar needle of the present invention, if the fine attachment allowance upper surface and the substrate upper surface are both flattened and smoothly connected so as not to be stepped, the fine needle and the attachment allowance are integrated and further strengthened. Thus, cracks hardly occur and the fine needles do not break during skin insertion, making it easier to pierce the skin.
本発明の微細糖質針においては、微細糖質針の針部が同方向を指すように、その基板を複数個重ねた剣山状構造の微細糖質針の外形を図14に示すが、この図では上記基板を3個重ねたものを示す。これにより、皮膚に刺さる微細針の数が増加するため、微細糖質針に搭載される薬剤等のチップ数も増加し、また、微細糖質針に含有される薬剤等の重量も増えるため、皮膚に対して多量の薬剤、栄養補助材、化粧材、生体物質を投与することが可能となる。
尚、図15は、基板そのものが複数層からなる微細糖質針の外形を示すが、複数層からなる基板を採用することにより、薄い層であっても複数層化することで、微細糖質針をさらに強固にすることが可能となり、また、基板を複数層とすることにより、既存のプラスチック、木、金属、紙、多糖材、ゼラチン、蛋白固形物を利用して厚さ調整することが可能となる。In the fine sugar needle of the present invention, the outer shape of a fine sugar needle having a sword-like structure in which a plurality of substrates are stacked so that the needle portion of the fine sugar needle points in the same direction is shown in FIG. In the drawing, three substrates are stacked. As a result, the number of fine needles that pierce the skin increases, so the number of chips such as drugs mounted on the fine saccharide needles also increases, and the weight of drugs etc. contained in the fine saccharide needles also increases. A large amount of drugs, nutritional supplements, cosmetics, and biological substances can be administered to the skin.
FIG. 15 shows the outer shape of a fine carbohydrate needle in which the substrate itself is composed of a plurality of layers. By adopting a substrate composed of a plurality of layers, a thin carbohydrate can be formed into a plurality of layers, thereby forming a fine carbohydrate. The needle can be made stronger, and the thickness of the substrate can be adjusted using existing plastic, wood, metal, paper, polysaccharides, gelatin, and protein solids by using multiple layers. It becomes possible.
本発明の微細糖質針においては、微細針上面と微細針取付け代上面に、薬剤や化粧材等をチップ化してグルコースによって接着させる構造とし、更に微細針上面と基板上面が平滑に繋がっておれば、そのチップを基板上面まで覆い被さって延長でき、薬剤等の投与の量的な拡大が可能となる。これと同時に、加熱溶解による成形後に薬剤あるいは化粧材の搭載が容易になるので、薬剤等の加熱劣化をも避けることが可能となった。この薬剤等を搭載した微細糖質針の一例の断面を図16、図17に示すが、図16は基板上面側端部に溶接された微細針取付け代を有する微細糖質針、図17は基板上面食い込み部に溶接された微細針取付け代を有する微細糖質針、を示すものである。 The fine sugar needle of the present invention has a structure in which a drug, a cosmetic material or the like is made into a chip and adhered by glucose on the fine needle upper surface and the fine needle mounting allowance upper surface, and the fine needle upper surface and the substrate upper surface are connected smoothly. For example, the chip can be covered and extended up to the upper surface of the substrate, so that the dose of a drug or the like can be expanded. At the same time, since it becomes easy to mount the medicine or the cosmetic material after the molding by heating and melting, it becomes possible to avoid the heat deterioration of the medicine or the like. FIGS. 16 and 17 show cross-sections of an example of a fine sugar needle loaded with this medicine, etc. FIG. 16 shows a fine sugar needle having a fine needle mounting allowance welded to the upper surface side end portion, and FIG. The fine saccharide needle | hook which has the fine needle attachment allowance welded to the board | substrate upper surface biting part is shown.
本発明の微細糖質針においては、微細針上面と微細針取付け代上面と基板上面とを段差なく一致させて滑らかな平滑面とするための製法として、微細針上面と微細針取付け代上面と基板上面を段差なく一致させて平坦化するために、それらの上面に対して種々の加圧や掃引を行うことにより達成することが可能となった。 In the fine sugar needle of the present invention, as a manufacturing method for making the upper surface of the fine needle, the upper surface of the fine needle mounting allowance, and the upper surface of the substrate coincide with each other without any step, the upper surface of the fine needle and the upper surface of the fine needle attachment allowance In order to flatten the upper surfaces of the substrates by making them coincide with each other without any level difference, it has become possible to achieve them by performing various pressurizations and sweeps on the upper surfaces.
本発明の微細糖質針における平坦化のための加圧には、微細針上面と微細針取付け代上面と基板上面とを同時に、重石部品あるいは圧力板等によって加圧して面同士を一致させる方法があり、これらの方法を用いることにより、上記の平坦化が可能となった。また、上記の平坦化のための掃引には、微細針上面から基板上面へ、あるいは逆の方向に掃引ヘラで面を擦りながら移動させる方法、微細針上面から基板上面へ、あるいは逆の方向に回転ローラで押えながら移動させる方法、可動シートの面を基板上面から微細針上面に掃引させて面同士を揃える方法、等々のいずれかの方法を用いることにより、上記の平坦化が可能となった。更には、これら上記の平坦化の方法に供する、加圧機構、掃引機構を有する微細針の製造装置を用いることにより、上記の平坦化が成された微細糖質針の製造が可能となった。ちなみに、上記の平坦化の方法の概略を示す模式図を、図18、図19、図20、図21に示す。ここでは、図18には重石部品又は圧力板を用いた加圧による平坦化の方法、図19には掃引ヘラを用いた掃引による平坦化の方法、図20には回転ローラを用いた加圧による平坦化の方法、図21には可動シートとして回転ローラによる巻きシートを用いた掃引による平坦化の方法を示す。これらの方法により、微細針上面と微細針取付け代上面と基板上面とを平坦化させ、連続する滑らかな平滑面とすることができる。更には、これらの平坦化の方法に供する、重石部品又は圧力板を用いた加圧機構、掃引ヘラ、掃引ブラシ、掃引ブレードを用いた掃引機構、回転して加圧するためのローラ、掃引のために用いた回転ローラによる巻きシートである可動シート、を有する製造装置を用いて、本発明の微細糖質針を精緻に、低コストで、効率よく製造することが可能となった。 In the pressurization for flattening in the fine sugar needle of the present invention, a method of pressurizing the upper surface of the fine needle, the upper surface of the fine needle attachment and the upper surface of the substrate simultaneously with a cobblestone or a pressure plate, etc. By using these methods, the above-described planarization is possible. In addition, the above sweeping for flattening includes a method of moving the surface from the top surface of the fine needle to the top surface of the substrate or in the opposite direction by rubbing the surface with a sweeping spatula, the top surface of the fine needle to the top surface of the substrate, or the reverse direction. By using one of the methods such as a method of moving while pressing with a rotating roller, a method of sweeping the surface of the movable sheet from the upper surface of the substrate to the upper surface of the fine needles, and the like, the above flattening can be performed. . Furthermore, by using a fine needle manufacturing apparatus having a pressurizing mechanism and a sweeping mechanism for use in the above-described flattening method, it is possible to manufacture a fine sugar needle having the above flattened structure. . Incidentally, schematic diagrams showing an outline of the above-described planarization method are shown in FIG. 18, FIG. 19, FIG. 20, and FIG. Here, FIG. 18 shows a flattening method using pressure using a heavy stone part or a pressure plate, FIG. 19 shows a flattening method using a sweeping spatula, and FIG. 20 shows pressurizing using a rotating roller. FIG. 21 shows a flattening method by sweeping using a wound sheet of a rotating roller as a movable sheet. By these methods, the fine needle upper surface, the fine needle mounting allowance upper surface, and the substrate upper surface can be flattened to form a continuous smooth surface. Furthermore, for these flattening methods, a pressurizing mechanism using a heavy stone part or a pressure plate, a sweeping spatula, a sweeping brush, a sweeping mechanism using a sweeping blade, a roller for rotating and pressurizing, for sweeping The fine sugar needle of the present invention can be precisely manufactured at low cost and efficiently using a manufacturing apparatus having a movable sheet that is a wound sheet by a rotating roller used in the above.
本発明の微細糖質針においては、微細針と同素材の糖質からなる微細針取付け代の側面に、1個の微細針を配列し、又はその微細針を櫛形状に複数個配列し、その微細針取付け代が微細針の糖質と異なる素材からなる基板の上面側端部に溶接された構造とすることにより、微細針とこの溶接による微細針取付け代が同素材の糖質からなる一体構造となるために、微細針を皮膚へ挿入させる際、微細針は折れ難く、皮膚へ刺さり易くなるという効果が得られ、これにより微細糖質針の実用性が飛躍的に向上した。 In the fine sugar needle of the present invention, one fine needle is arranged on the side surface of the fine needle mounting allowance made of the same material as the fine needle, or a plurality of the fine needles are arranged in a comb shape, By adopting a structure in which the fine needle mounting allowance is welded to the upper surface side end portion of the substrate made of a material different from the sugar of the fine needle, the fine needle and the fine needle mounting allowance by this welding are made of the same material sugar. Due to the integrated structure, when the fine needle is inserted into the skin, the fine needle is difficult to break and can be easily pierced into the skin, thereby dramatically improving the practicality of the fine sugar needle.
本発明の微細糖質針においては、微細針と同素材の糖質からなる微細針取付け代の側面に1個の微細針を配列し、又はその微細針を櫛形状に複数個配列し、その微細針取付け代が微細針の糖質と異なる素材からなる基板の上面食い込み部に溶接され、かつその微細針上面とこの微細針取付け代上面とが連続して平滑した構造とすることにより、微細針とこの食い込みによる微細針取付け代が同素材の糖質からなる一体構造となるために微細針を折れ難く、微細針を皮膚へ挿入させる際、微細針は折れ難く、皮膚へ刺さり易くなるという効果が得られ、これにより微細糖質針の実用性が飛躍的に向上した。 In the fine saccharide needle of the present invention, one fine needle is arranged on the side surface of the fine needle attachment allowance made of the same material as the fine needle, or a plurality of the fine needles are arranged in a comb shape, The fine needle mounting allowance is welded to the top biting portion of the substrate made of a material different from the sugar of the fine needle, and the fine needle upper surface and the fine needle attaching allowance upper surface are continuously smoothed to achieve a fine structure. Because the needle and the fine needle mounting allowance by this bite are integrated structure made of sugar of the same material, it is difficult to break the fine needle, and when inserting the fine needle into the skin, the fine needle is difficult to break and is easy to pierce the skin As a result, the practicality of the fine saccharide needles has been dramatically improved.
本発明の微細糖質針においては、更に、微細取付け代上面と基板上面をも共に段差なく一致させるように平坦化して滑らかに繋げば、微細針と取付け代とが一体化してさらに強固になり、ほとんどクラックが入り難く、皮膚挿入の際に微細針が折れず、皮膚に刺さり易くなるという効果が得られ、これにより微細糖質針の実用性が大きく向上した。そして、本発明の剣山状構造を有する微細糖質針においては、皮膚に刺さる微細針の数が増加するため、微細糖質針に搭載される薬剤等のチップ数も増加し、又は微細糖質針に含有される薬剤等の重量も増えるため、皮膚に対して多量の薬剤、栄養補助材、化粧材、生体物質を投与し易くなるという効果が得られ、これにより微細糖質針の実用性がより大きく向上した。更に、本発明の微細糖質針においては、複数層からなる基板を採用することにより、薄い層であっても複数層化することで、微細糖質針をさらに強固にするという効果が得られ、これにより微細糖質針の実用性がさらに大きく向上した。 In the fine sugar needle of the present invention, if the fine attachment allowance surface and the substrate upper surface are both flattened and smoothly connected so that there is no step, the fine needle and the attachment allowance are integrated and become stronger. As a result, cracks hardly occur, the fine needles do not break during skin insertion, and it is easy to pierce the skin, thereby greatly improving the practicality of the fine sugar needles. And, in the fine saccharide needle having the sword-like structure of the present invention, the number of fine needles that pierce the skin increases, so the number of chips such as drugs mounted on the fine saccharide needle also increases, or the fine saccharides Since the weight of the drug contained in the needle also increases, the effect of facilitating the administration of a large amount of drug, nutritional supplement, cosmetic material, and biological substance to the skin is obtained, thereby the practicality of the fine sugar needle Improved significantly. Furthermore, in the fine saccharide needle of the present invention, the effect of further strengthening the fine saccharide needle can be obtained by adopting a substrate composed of a plurality of layers, so that even a thin layer is formed into a plurality of layers. This greatly improved the practicality of the fine sugar needle.
本発明の微細糖質針においては、微細針上面と微細針取付け代上面に、薬剤や化粧材等をチップ化してグルコースによって接着させる構造とし、更に微細針上面と基板上面が平滑に繋がっておれば、そのチップを基板上面まで覆い被さって延長でき、薬剤等の投与の量的な拡大が可能になるという効果が得られた。この効果ともに、加熱溶解による成形後に薬剤あるいは化粧材の搭載が容易になるので、薬剤等の加熱劣化をも避けることが可能になるという効果が得られ、これらの効果により、微細糖質針の実用性が飛躍的に向上した。 The fine sugar needle of the present invention has a structure in which a drug, a cosmetic material or the like is made into a chip and adhered by glucose on the fine needle upper surface and the fine needle mounting allowance upper surface, and the fine needle upper surface and the substrate upper surface are connected smoothly. In this case, the chip can be covered and extended to the upper surface of the substrate, and the effect that the amount of administration of a drug or the like can be expanded is obtained. In addition to this effect, since it becomes easy to mount the drug or cosmetic material after molding by heat dissolution, the effect that it is possible to avoid heat deterioration of the drug etc. is obtained. Practicality has improved dramatically.
本発明の微細糖質針においては、微細針上面と微細針取付け代上面と基板上面とを段差なく一致させて滑らかな平滑面とするための製法として、微細針上面と微細針取付け代上面と基板上面を段差なく一致させて平坦化するために、それらの上面に対して種々の加圧や掃引を行うことにより達成し得るという効果が得られた。また、これらの平坦化の方法に供する、重石部品又は圧力板を用いた加圧機構、掃引ヘラ、掃引ブラシ、掃引ブレードを用いた掃引機構、回転して加圧するためのローラ、掃引のために用いた回転ローラによる巻きシートである可動シート、を有する製造装置を用いて、本発明の微細糖質針を精緻に、低コストで、効率よく製造し得るという効果が得られた。 In the fine sugar needle of the present invention, as a manufacturing method for making the upper surface of the fine needle, the upper surface of the fine needle mounting allowance, and the upper surface of the substrate coincide with each other without any step, the upper surface of the fine needle and the upper surface of the fine needle attachment allowance In order to flatten the upper surfaces of the substrates by making them coincide with each other without any step, an effect is obtained that can be achieved by performing various pressurizations and sweeps on the upper surfaces. For these flattening methods, pressurization mechanism using weight parts or pressure plate, sweep spatula, sweep brush, sweep mechanism using sweep blade, roller for rotating and pressurizing, for sweeping Using the manufacturing apparatus having the movable sheet that is a wound sheet by the used rotating roller, an effect that the fine sugar needle of the present invention can be manufactured precisely, at low cost and efficiently was obtained.
以下に、本発明における微細糖質針、その製造法及び製造装置の実施形態について説明を行うが、本発明は以下の実施形態に何ら限定されるものではない。 Hereinafter, embodiments of the fine sugar needle, the production method, and the production apparatus of the present invention will be described, but the present invention is not limited to the following embodiments.
本発明において、微細糖質針とは糖質からなる微細針を意味し、微細針の具体的な大きさとしては、針先端部から針底面部までの垂線長が100μmから2mm、針底面部横幅が20μmから1mm、針底面部縦幅が20μmから1mmが好ましい。尚、図22は、図6に示した微細針部位8(波線状円内)を拡大した概略図であるが、針先端部から針底面部までの垂線長19、針底面部横幅20、針底面部縦幅21は図示の通りである。また、針底面部の形状は三角形状、多角形状、半円形状等、様々な形状をとることができ、特に形状は限定されない。ここで、針先端部から針底面部までの垂線長が100μmより小さい場合は、皮膚表面の凹凸による厚さより小さいという理由から、上記の垂線長が2mmより大きい場合は、皮膚への挿入が困難になり痛みが発生するという理由から好ましくない。また、針底面部横幅が20μmより小さい場合は、針が脆弱になるという理由から、上記の針底面部横幅が1mmより大きい場合は、皮膚への挿入が困難になり痛みが発生するという理由から好ましくない。更に、針底面部縦幅が20μmより小さい場合は、針が脆弱になるという理由から、上記の針底面部縦幅が1mmより大きい場合は、皮膚への挿入が困難になり痛みが発生するという理由から好ましくない。 In the present invention, the fine saccharide needle means a fine needle composed of a saccharide, and the specific size of the fine needle is as follows: the perpendicular length from the needle tip to the needle bottom is 100 μm to 2 mm, the needle bottom The lateral width is preferably 20 μm to 1 mm, and the needle bottom portion vertical width is preferably 20 μm to 1 mm. FIG. 22 is an enlarged schematic view of the fine needle portion 8 (inside the wavy circle) shown in FIG. 6, but the
本発明における微細糖質針は、微細針と同素材の糖質からなる取付け代の側面に1個の上記微細針を配列し、又はその微細針を櫛形状に複数個配列し、その微細針取付け代が微細針の糖質と異なる素材からなる基板の上面側端部に溶接された構造を有する。尚、ここでいう溶接とは、文字通り、取付け代の素材である糖質が吸湿や熱により溶けた状態で、糖質とは異なる素材である基板と接着することを意味し、この場合、溶けた状態の糖質が接着剤の様な役割を担うことになる。 The fine saccharide needle in the present invention is arranged such that one fine needle is arranged on the side surface of the mounting allowance made of the same material as the fine needle, or a plurality of fine needles are arranged in a comb shape. It has a structure in which the mounting allowance is welded to the upper surface side end portion of the substrate made of a material different from the sugar of the fine needle. The term “welding” as used herein literally means that the saccharide, which is the material of the mounting allowance, is melted by moisture absorption or heat, and is bonded to the substrate, which is a material different from the saccharide. Carbohydrates in the state of a role play a role like an adhesive.
本発明における微細糖質針は、微細針と同素材の糖質からなる微細針取付け代の側面に1個の上記微細針を配列し、又はその微細針を櫛形状に複数個配列し、その微細針取付け代が微細針の糖質と異なる素材からなる基板の上面食い込み部に溶接され、かつその微細針上面とこの微細針取付け代上面とが連続して平滑した構造を有する。更には、その微細糖質針において、微細針取付け代上面と基板上面とが連続して平滑した構造を有する。尚、ここでいう溶接とは、前述の溶接と同様の意味であり、溶けた状態の糖質が接着剤の役割を担うことになる。また、別態様の微細糖質針としては、上記の微細糖質針において、微細糖質針が同方向を指すように基板を複数個重ねた剣山状構造を有する。更には、別態様の微細糖質針としては、上記の微細糖質針の基板が複数層からなる構造を有する。ちなみに、上記基板の上面食い込み部は、二酸化炭素レーザー加工(出力が5Wから100W程度)により作製することができる。 The fine saccharide needle in the present invention is arranged such that one fine needle is arranged on the side surface of the fine needle mounting allowance made of the same material as the fine needle, or a plurality of the fine needles are arranged in a comb shape, The fine needle mounting allowance is welded to the upper biting portion of the substrate made of a material different from the sugar of the fine needle, and the upper surface of the fine needle and the upper surface of the fine needle attaching allowance are continuously smooth. Furthermore, the fine sugar needle has a structure in which the upper surface of the fine needle mounting allowance and the upper surface of the substrate are continuously smooth. In addition, welding here has the same meaning as the above-mentioned welding, and the dissolved saccharide plays a role of an adhesive. In another aspect, the fine sugar needle has a sword mountain structure in which a plurality of substrates are stacked such that the fine sugar needles point in the same direction. Furthermore, another embodiment of the fine sugar needle has a structure in which the substrate of the fine sugar needle is composed of a plurality of layers. Incidentally, the top biting portion of the substrate can be produced by carbon dioxide laser processing (output is about 5 W to 100 W).
本発明における微細糖質針は、その基板の素材が、プラスチック、木、金属、紙、多糖材、ゼラチン、蛋白固形物から選ばれる1又は2以上であることを特徴とする。ここで、プラスチックとしてはポリプロピレン、ポリエチレン、ポリ乳酸のような生分解性プラスチック、木としては折り詰め弁当の板木、バルサ材、金属としてはスチール、ステンレス、白金、銀、多糖材としてはプルラン、CMC、蛋白固形物としてはコラーゲン、ヒアルロン酸、キトサン、が好適に使用され得る。 The fine sugar needle of the present invention is characterized in that the substrate material is one or more selected from plastic, wood, metal, paper, polysaccharide material, gelatin, and protein solid. Here, biodegradable plastics such as polypropylene, polyethylene, and polylactic acid are used as plastics, wooden boards for folded lunch boxes, balsa materials as wood, steel, stainless steel, platinum, silver as metals, pullulan and CMC as polysaccharide materials. As the protein solid, collagen, hyaluronic acid, and chitosan can be preferably used.
本発明における微細糖質針は、その糖質がマルトースであり、該基板の素材が紙であることを特徴とする。ここで、マルトースとしては無水非結晶マルトース、紙としては紙コップに使用される食品用衛生紙、が好適に使用され得る。 The fine sugar needle in the present invention is characterized in that the sugar is maltose and the material of the substrate is paper. Here, anhydrous amorphous maltose can be suitably used as maltose, and sanitary paper for food used for paper cups can be suitably used as paper.
本発明における微細糖質針は、その微細針上面と連続平滑面をなす取付け代上面の両上面にグルコースを被覆し、そのグルコース被覆面上に薬剤を搭載したことを特徴とする。また、本発明における微細糖質針は、その微細針内部に薬剤を含有したことを特徴とする。 The fine sugar needle according to the present invention is characterized in that glucose is coated on both upper surfaces of the upper surface of the attachment allowance which forms a continuous smooth surface with the upper surface of the fine needle, and the drug is mounted on the glucose coated surface. The fine saccharide needle of the present invention is characterized in that a drug is contained in the fine needle.
本発明における微細糖質針は、その薬剤が、アスコルビン酸ナトリウム、アスコルビン酸マグネシウム、ヒアルロン酸、コラーゲン、ヒトIgG、ヒトIgM、抗体医薬、核酸医薬、色素、ビタミンA、ビタミン類、インスリン、ホルモン、から選ばれる1又は2以上であることを特徴とする。ここで、ヒトIgGとしては血液障害のための薬剤等、ヒトIgMとしては異物に対応する消炎薬剤等、抗体医薬としては主に抗癌剤等、核酸医薬としてはDNA治療薬剤等、色素としては藍等の植物性色素、刺青用色素、ビタミン類としてはビタミンB、ビタミンD等があり、これらが好適に使用され得る。 The fine sugar needle in the present invention is composed of sodium ascorbate, magnesium ascorbate, hyaluronic acid, collagen, human IgG, human IgM, antibody drug, nucleic acid drug, dye, vitamin A, vitamins, insulin, hormone, It is 1 or 2 or more chosen from these, It is characterized by the above-mentioned. Here, human IgG is a drug for blood disorders, human IgM is an anti-inflammatory drug corresponding to a foreign substance, an antibody drug is mainly an anticancer drug, a nucleic acid drug is a DNA therapeutic drug, a dye is indigo, etc. Examples of plant pigments, tattoo pigments, and vitamins include vitamin B and vitamin D, which can be suitably used.
本発明における微細糖質針は、その微細針上面と連続平滑面をなす取付け代上面の両上面にグルコースを被覆し、そのグルコース被覆面上に生体物質を搭載したことを特徴とする。本発明における微細糖質針は、その微細針内部に生体物質を内包したことを特徴とする。 The fine sugar needle according to the present invention is characterized in that glucose is coated on both upper surfaces of the upper surface of the attachment allowance that forms a continuous smooth surface with the upper surface of the fine needle, and a biological material is mounted on the glucose coated surface. The fine sugar needle in the present invention is characterized in that a biological substance is encapsulated in the fine needle.
本発明における微細糖質針は、その生体物質が、DNA、アミノ酸、蛋白質、ヒトIgG抗体、ワクチン、細胞内微小体、細胞、微生物から選ばれる1又は2以上であることを特徴とする。ここで、細胞微小体としてはゴルジ体、ミトコンドリア等、細胞としては皮膚細胞、毛根細胞、幹細胞等、微生物としては乳酸菌、青カビ等、が好適に使用され得る。 The fine carbohydrate needle in the present invention is characterized in that the biological material is one or more selected from DNA, amino acid, protein, human IgG antibody, vaccine, intracellular microbody, cell and microorganism. Here, Golgi bodies, mitochondria, etc. can be suitably used as the cell microparticles, skin cells, hair root cells, stem cells, etc. as the cells, and lactic acid bacteria, green molds, etc. as the microorganisms.
本発明における微細糖質針は、その製造方法としては、微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の微細針上面と、基板上面側端部又は基板上面食い込み部に設けた微細針取付け代上面と、基板上面とを平滑面とするべく、微細針上面と微細針取付け代上面と基板上面とを加圧して平坦化させる方法を用いることを特徴とする。また、本発明における微細糖質針は、その製造装置としては、上記の平坦化させる方法に供する加圧機構を有することを特徴とする。ここで、加圧機構としては重石部品又は圧力板が好適に使用され得る。 The method for producing the fine sugar needle in the present invention includes a method for independently using a die dedicated to the fine needle separated from the substrate when the fine sugar needle is manufactured. , Pressurize and flatten the fine needle upper surface, the fine needle attachment allowance surface, and the substrate upper surface so that the fine needle attachment allowance surface provided on the upper surface side edge of the substrate or the upper surface biting portion of the substrate and the upper surface of the substrate become a smooth surface. It is characterized by using the method to make. Moreover, the fine carbohydrate needle | hook in this invention has a pressurization mechanism with which it uses for said flattening method as the manufacturing apparatus. Here, a heavy stone part or a pressure plate can be suitably used as the pressurizing mechanism.
本発明における微細糖質針は、その製造方法としては、微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の微細針上面と、基板上面側端部又は基板上面食い込み部に設けた微細針取付け代上面と、基板上面とを平滑面とするべく、微細針上面と微細針取付け代上面と基板上面とを掃引して平坦化させる方法を用いることを特徴とする。また、本発明における微細糖質針は、その製造装置としては、上記の平坦化させる方法に供する掃引機構を有することを特徴とする。ここで、掃引機構としては掃引ヘラ、掃引ブラシ、掃引ブレードが好適に使用され得る。 The method for producing the fine sugar needle in the present invention includes a method for independently using a die dedicated to the fine needle separated from the substrate when the fine sugar needle is manufactured. In order to make the fine needle mounting allowance upper surface provided on the upper surface side edge or the substrate upper bite and the upper surface of the substrate smooth, the upper surface of the fine needle, the upper allowance surface of the fine needle, and the upper surface of the substrate are swept and flattened. It is characterized by using the method to make. In addition, the fine sugar needle in the present invention is characterized in that, as a manufacturing apparatus thereof, has a sweep mechanism used for the above-described flattening method. Here, a sweeping spatula, a sweeping brush, or a sweeping blade can be suitably used as the sweeping mechanism.
本発明における微細糖質針は、その製造方法としては、微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の微細針上面と、基板上面側端部又は基板上面食い込み部に設けた微細針取付け代上面と、基板上面とを平滑面とするべく、微細針上面と微細針取付け代上面と基板上面とを回転ローラにより加圧して平坦化させる方法を用いることを特徴とする。また、本発明における微細糖質針は、その製造装置としては、上記の平坦化させる方法に供する回転ローラを有することを特徴とする。 The method for producing the fine sugar needle in the present invention includes a method for independently using a die dedicated to the fine needle separated from the substrate when the fine sugar needle is manufactured. The fine needle top surface, the fine needle mounting allowance surface, and the substrate top surface are pressurized by a rotating roller so that the fine needle mounting allowance surface provided on the upper surface side edge of the substrate or the substrate upper surface biting portion and the substrate upper surface are smooth. And using a flattening method. In addition, the fine sugar needle according to the present invention is characterized in that the production apparatus has a rotating roller for use in the above-described flattening method.
本発明における微細糖質針は、その製造方法としては、微細糖質針を製作する際、基板より分離した微細針専用の金型を独立に用いる方法において、金型分離後の微細針上面と、基板上面側端部又は基板上面食い込み部に設けた微細針取付け代上面と、基板上面とを平滑面とするべく、微細針上面と微細針取付け代上面と基板上面とを可動シートにより掃引して平坦化させる方法を用いることを特徴とする。また、本発明における微細糖質針は、その製造装置としては、上記の平坦化させる方法に供する可動シートを有することを特徴とする。ここで、可動シートとしては回転ローラによる巻きシートが好適に使用され得る。 The method for producing the fine sugar needle in the present invention includes a method for independently using a die dedicated to the fine needle separated from the substrate when the fine sugar needle is manufactured. The top surface of the fine needle, the top surface of the fine substrate, and the top surface of the fine substrate are swept by a movable sheet so as to make the top surface of the fine needle mounting surface and the top surface of the substrate top surface smooth. And using a flattening method. Moreover, the fine carbohydrate needle | hook in this invention has the movable sheet | seat used for said flattening method as the manufacturing apparatus, It is characterized by the above-mentioned. Here, a wound sheet by a rotating roller can be suitably used as the movable sheet.
以下に、本発明について実施例により具体的な説明を行うが、本発明は以下の実施例に何ら限定されるものではない。 Hereinafter, the present invention will be described in detail with reference to examples, but the present invention is not limited to the following examples.
針先端部から針底面部までの垂線長が500μm、針底面部横幅が100μm、針底面部縦幅が100μmの無水非結晶マルトースからなる微細針30本(針底面部形状は三角形)について、微細針部の成形と基板部の成形を分離して行うため、個別の金型を独立に使う方法による製作において、上記垂線と上記縦幅を通る面で切った際の断面が山形状(上記垂線方向に沿う底辺500μm、上記縦幅方向に沿う高さ100μm)の無水非結晶マルトースからなる微細針取付け代の側面に櫛形状に設け、この微細針取付け代を溶接により、食品用衛生紙からなる基板(上記横幅方向に沿う横長さ10mm、上記底辺方向に沿う縦長さ10mm、厚さ0.5mm)の上面側端部に設けた構造を有する微細針(その外形の概略図は図5の通り)を作製した。この微細糖質針を用いて皮膚挿入試験を行ってみたところ、微細針は十分な強度があり、30本の微細針の全てが折れることなく、更には痛みを伴わずに、安全に皮膚に刺さることが確認された。尚、これらの皮膚内に残留した微細針は全て、糖質であるために挿入後すみやかに皮膚内で溶解することとなった。 About 30 fine needles made of anhydrous amorphous maltose with a vertical length of 500 μm from the needle tip to the needle bottom, a needle bottom width of 100 μm, and a needle bottom length of 100 μm (the needle bottom is triangular) Since the forming of the needle part and the forming of the substrate part are performed separately, in the production by the method of using individual molds independently, the cross section when cut by the plane passing through the vertical line and the vertical width is a mountain shape (the vertical line) A substrate made of food sanitary paper by welding the fine needle attachment allowance by welding on the side of the fine needle attachment allowance made of anhydrous amorphous maltose with a base of 500 μm along the direction and a height of 100 μm along the vertical width direction) (Fine needle having a structure provided on the upper surface side end portion of the horizontal length of 10 mm along the width direction, the vertical length of 10 mm along the bottom direction, and the thickness of 0.5 mm). Make did. When a skin insertion test was performed using this fine sugar needle, the fine needle had sufficient strength, and all 30 fine needles did not break, and even without pain, it was safely applied to the skin. It was confirmed to be stabbed. In addition, since all of these fine needles remaining in the skin were carbohydrates, they immediately dissolved in the skin after insertion.
針先端部から針底面部までの垂線長が500μm、針底面部横幅が100μm、針底面部縦幅が100μmの無水非結晶マルトースからなる微細針20本(針底面部形状は三角形)について、微細針部の成形と基板部の成形を分離して行うため、個別の金型を独立に使う方法による製作において、上記垂線と上記縦幅を通る面で切った際の断面が長方形状(上記垂線方向に沿う底辺500μm、上記縦幅方向に沿う高さ100μm)の無水非結晶マルトースからなる微細針取付け代の側面に櫛形状に設け、この微細針取付け代を溶接により、食品用衛生紙からなる基板(上記横幅方向に沿う横長さ10mm、上記底辺方向に沿う縦長さ10mm、厚さ0.5mm)の上面食い込み部に設け、かつ微細針上面と微細針取付け代上面とが連続して平滑した構造を有する微細針(その外形の概略図は図6の通り)を作製した。尚、上記の基板上面食い込み部は、二酸化炭素レーザー加工(出力が10W程度)により作製した。更に、上記の平滑構造のために用いた平坦化方法として、圧力板をテフロン板とした加圧機構を有する装置により、微細針上面と微細針取付け代上面とを同時に加圧して行い、これら上面を段差のない平滑面とした。この時、これら上面の粗さを±5μm以内の面精度にすることができた。この微細糖質針を用いて皮膚挿入試験を行ってみたところ、微細針は十分な強度があり、20本の微細針の全てが折れることなく、更には痛みを伴わずに、安全に皮膚に刺さることが確認された。尚、これらの皮膚内に残留した微細針は全て、糖質であるために挿入後すみやかに皮膚内で溶解することとなった。 About 20 fine needles made of anhydrous amorphous maltose with a perpendicular length from the needle tip to the needle bottom of 500 μm, a needle bottom width of 100 μm, and a needle bottom length of 100 μm (the needle bottom is triangular) Since the forming of the needle part and the forming of the substrate part are performed separately, in the production by the method of using individual molds independently, the cross section when cut by the plane passing through the vertical line and the vertical width is rectangular (the vertical line) A substrate made of food sanitary paper by welding the fine needle attachment allowance by welding on the side of the fine needle attachment allowance made of anhydrous amorphous maltose with a base of 500 μm along the direction and a height of 100 μm along the vertical width direction) Provided in the upper bite portion (
針先端部から針底面部までの垂線長が500μm、針底面部横幅が100μm、針底面部縦幅が100μmの無水非結晶マルトースからなる微細針20本(針底面部形状は三角形)について、微細針部の成形と基板部の成形を分離して行うため、個別の金型を独立に使う方法による製作において、上記垂線と上記縦幅を通る面で切った際の断面が長方形状(上記垂線方向に沿う底辺500μm、上記縦幅方向に沿う高さ100μm)の無水非結晶マルトースからなる微細針取付け代の側面に櫛形状に設け、この微細針取付け代を溶接により、食品用衛生紙からなる基板(上記横幅方向に沿う横長さ10mm、上記底辺方向に沿う縦長さ10mm、厚さ0.5mm)の上面食い込み部に設け、かつ微細針上面と微細針取付け代上面とが連続して平滑し、更に、微細針取付け代上面と基板上面とが連続して平滑した構造を有する微細針(その外形の概略図は図6の通り)を作製した。尚、上記の基板上面食い込み部は、二酸化炭素レーザー加工(出力が10W程度)により作製した。更に、上記の平滑構造のために用いた平坦化方法として、テフロンからなる掃引ヘラ(厚さ500μm)とした掃引機構を有する装置により、微細針上面と微細針取付け代上面と基板上面とを掃引して行い、これら上面を段差のない平滑面とした。この時、これら上面の粗さを±10μm以内の面精度にすることができた。この微細糖質針を用いて皮膚挿入試験を行ってみたところ、微細針は十分な強度があり、20本の微細針の全てが折れることなく、更には痛みを伴わずに、安全に皮膚に刺さることが確認され、これらの皮膚内に残留した微細針は全て、糖質であるために挿入後すみやかに皮膚内で溶解することとなった。 About 20 fine needles made of anhydrous amorphous maltose with a perpendicular length from the needle tip to the needle bottom of 500 μm, a needle bottom width of 100 μm, and a needle bottom length of 100 μm (the needle bottom is triangular) Since the forming of the needle part and the forming of the substrate part are performed separately, in the production by the method of using individual molds independently, the cross section when cut by the plane passing through the vertical line and the vertical width is rectangular (the vertical line) A substrate made of food sanitary paper by welding the fine needle attachment allowance by welding on the side of the fine needle attachment allowance made of anhydrous amorphous maltose with a base of 500 μm along the direction and a height of 100 μm along the vertical width direction) Provided in the upper bite portion (
上記実施例2の微細糖質針を上記実施例2と同様の方法にて3個作製し、微細糖質針が同方向を指すように、これらの基板を3個重ねることにより、剣山状構造を有する微細糖質針(その外形の概略図は図14の通り)を作製した。この微細糖質針を用いて皮膚挿入試験を行ってみたところ、微細針は十分な強度があり、60本の微細針の全てが折れることなく、更には痛みを伴わずに、安全に皮膚に刺さることが確認された。尚、これらの皮膚内に残留した微細針は全て、糖質であるために挿入後すみやかに皮膚内で溶解することとなった。 Three fine sugar needles of Example 2 were produced by the same method as in Example 2, and three of these substrates were stacked so that the fine sugar needles pointed in the same direction, whereby a sword mountain structure A fine sugar needle having a shape (a schematic view of its outer shape is as shown in FIG. 14). When a skin insertion test was performed using this fine sugar needle, the fine needle had sufficient strength, and all 60 fine needles did not break, and even without pain, it was safely applied to the skin. It was confirmed to be stabbed. In addition, since all of these fine needles remaining in the skin were carbohydrates, they immediately dissolved in the skin after insertion.
上記実施例3の微細糖質針を上記実施例3と同様の方法にて3個作製し、微細糖質針が同方向を指すように、これらの基板を3個重ねることにより、剣山状構造を有する微細糖質針(その外形の概略図は図14の通り)を作製した。この微細糖質針を用いて皮膚挿入試験を行ってみたところ、微細針は十分な強度があり、60本の微細針の全てが折れることなく、更には痛みを伴わずに、安全に皮膚に刺さることが確認され、これらの皮膚内に残留した微細針は全て、糖質であるために挿入後すみやかに皮膚内で溶解することとなった。 Three fine sugar needles of Example 3 were prepared by the same method as in Example 3, and three of these substrates were stacked so that the fine sugar needles pointed in the same direction. A fine sugar needle having a shape (a schematic view of its outer shape is as shown in FIG. 14). When a skin insertion test was performed using this fine sugar needle, the fine needle had sufficient strength, and all 60 fine needles did not break, and even without pain, it was safely applied to the skin. All of the fine needles remaining in the skin were confirmed to be stabbed and dissolved in the skin immediately after insertion because they were carbohydrates.
基板の最下層をポリエチレン(厚さ100μm)として、その上に順番に食品衛生紙(厚さ300μm)、同食品衛生紙(厚さ300μm)、ポリプロピレン(厚さ100μm)を重ねたものを基板に用い、それ以外は全て上記実施例3と同様の方法にて、基板が4層からなる微細糖質針(その断面の概略図は図15の通り)を作製した。これにより、食品衛生紙である基板が直接に指で触れられることなく、プラスチックフィルム被覆による強度の高い基板を有する微細糖質針となった。この微細糖質針を用いて皮膚挿入試験を行ってみたところ、微細針は十分な強度があり、20本の微細針の全てが折れることなく、更には痛みを伴わずに、安全に皮膚に刺さることが確認された。尚、これらの皮膚内に残留した微細針は全て、糖質であるために挿入後すみやかに皮膚内で溶解することとなった。 The bottom layer of the substrate is polyethylene (thickness 100 μm), and on the substrate, food hygiene paper (thickness 300 μm), food hygiene paper (thickness 300 μm), and polypropylene (thickness 100 μm) are used for the substrate. Except that, a fine sugar needle having a four-layered substrate (schematic cross-sectional view as shown in FIG. 15) was prepared in the same manner as in Example 3 above. As a result, the substrate, which is food sanitary paper, was not directly touched with a finger, and a fine sugar needle having a substrate with high strength by plastic film coating was obtained. When a skin insertion test was performed using this fine sugar needle, the fine needle had sufficient strength, and all of the 20 fine needles did not break, and even without pain, it was safely applied to the skin. It was confirmed to be stabbed. In addition, since all of these fine needles remaining in the skin were carbohydrates, they immediately dissolved in the skin after insertion.
平滑構造のために用いた平坦化方法として、直径1cmのテフロンシートを巻いたローラを有する装置により、微細針上面と微細針取付け代上面と基板上面とを上記の回転ローラにより加圧して、これら上面を段差のない平滑面とし、それ以外は全て上記実施例3と同様の方法にて、これらの3上面が連続して平滑した構造を有する微細糖質針(その外形の概略図は図6の通り)を作製した。この時、これら上面の粗さを±10μm以内の面精度にすることができた。この微細糖質針を用いて皮膚挿入試験を行ってみたところ、微細針は十分な強度があり、20本の微細針の全てが折れることなく、更には痛みを伴わずに、安全に皮膚に刺さることが確認された。尚、これらの皮膚内に残留した微細針は全て、糖質であるために挿入後すみやかに皮膚内で溶解することとなった。 As a flattening method used for the smooth structure, an apparatus having a roller wound with a Teflon sheet having a diameter of 1 cm is used to press the upper surface of the fine needle, the upper surface of the fine needle mounting surface, and the upper surface of the substrate with the above rotating roller. A fine sugar needle having a structure in which the upper surface is a smooth surface having no step and the other three upper surfaces are continuously smoothed in the same manner as in Example 3 above (a schematic diagram of the outer shape is shown in FIG. 6). As shown in FIG. At this time, the surface roughness of these upper surfaces could be made within ± 10 μm. When a skin insertion test was performed using this fine sugar needle, the fine needle had sufficient strength, and all of the 20 fine needles did not break, and even without pain, it was safely applied to the skin. It was confirmed to be stabbed. In addition, since all of these fine needles remaining in the skin were carbohydrates, they immediately dissolved in the skin after insertion.
平滑構造のために用いた平坦化方法として、厚さ50μmのテフロンシートを巻いたステンレスのローラを可動シートとして有する装置により、微細針上面と微細針取付け代上面と基板上面とを上記回転ローラのテフロンシートにより掃引して、これら上面を段差のない平滑面とし、それ以外は全て上記実施例3と同様の方法にて、これらの3上面が連続して平滑した構造を有する微細糖質針(その外形の概略図は図6の通り)を作製した。この時、これら上面の粗さを±3μm以内の面精度にすることができた。この微細糖質針を用いて皮膚挿入試験を行ってみたところ、微細針は十分な強度があり、20本の微細針の全てが折れることなく、更には痛みを伴わずに、安全に皮膚に刺さることが確認された。尚、これらの皮膚内に残留した微細針は全て、糖質であるために挿入後すみやかに皮膚内で溶解することとなった。 As a flattening method used for the smooth structure, a fine needle upper surface, a fine needle mounting allowance upper surface and a substrate upper surface are connected to the rotating roller by an apparatus having a stainless steel roller wound with a 50 μm thick Teflon sheet as a movable sheet. A fine sugar needle having a structure in which these upper surfaces are continuously smoothed by the same method as in Example 3 except that the upper surfaces are made smooth with no step by sweeping with a Teflon sheet. The outline of the outline is as shown in FIG. At this time, the roughness of these upper surfaces was able to be a surface accuracy within ± 3 μm. When a skin insertion test was performed using this fine sugar needle, the fine needle had sufficient strength, and all of the 20 fine needles did not break, and even without pain, it was safely applied to the skin. It was confirmed to be stabbed. In addition, since all of these fine needles remaining in the skin were carbohydrates, they immediately dissolved in the skin after insertion.
加熱溶解法(80℃に一定加熱後、被溶解物を溶解させる)により、無水非結晶マルトースにアスコルビン酸ナトリウムを3重量%含有させたものを原料素材として用い、それ以外は全て上記実施例7と同様の方法にて、アスコルビン酸ナトリウムを含有した微細糖質針(その外形の概略図は図6の通り)を作製した。この微細糖質針について、顔面における肌美白を目的として、50才代の女性被験者の顔の皮膚の一部に1日1回の挿入試験を行ったところ、微細針挿入部位付近における皮膚の写真撮影による比較検討の結果、100日後に美白効果が確認された。 Example 7 was used except that 3% by weight of sodium ascorbate was added to anhydrous amorphous maltose as a raw material by the heating dissolution method (after constant heating at 80 ° C. to dissolve the material to be dissolved). In the same manner as above, a fine sugar needle containing sodium ascorbate (schematic diagram of its outer shape is as shown in FIG. 6) was prepared. This fine sugar needle was subjected to an insertion test once a day on a part of the face skin of a female test subject in the 50s for the purpose of skin whitening on the face. As a result of comparative examination by photographing, a whitening effect was confirmed after 100 days.
微細針上面と微細針取付け代上面の両上面にグルコースを、塗布用微細ハケを用いて被覆し、その20ヶ所の被覆面上の各々に、アスコルビン酸ナトリウムを円板形状(直径50μm、厚さ20μm)に断片(チップ)化したものを1個ずつ搭載させ、それ以外は全て上記実施例7と同様の方法にて、アスコルビン酸ナトリウムのチップを搭載した微細糖質針(その断面の概略図は図17の通り)を作製した。この微細糖質針について、顔面における肌美白を目的として、女性被験者(実施例9と同様)の顔の皮膚の一部に1日1回の挿入試験を行ったところ、微細針挿入部位付近における皮膚の写真撮影による比較検討の結果、60日後に美白効果が確認された。このことは、アスコルビン酸リン酸ナトリウムのような加熱分解しやすい特性のあるビタミンCは、実施例9による方法ではその一部が加熱により分解し美白効果が多少減少するが、本実施例のようにチップ化して上記グルコース被覆面上に搭載させれば、加熱過程を経ることがないので分解せず、美白効果が十分に発揮し得ることが確認された。 Glucose is coated on both upper surfaces of the fine needle upper surface and the fine needle mounting allowance surface using a fine brush for application, and sodium ascorbate is formed in a disk shape (diameter 50 μm, thickness on each of the 20 coated surfaces. 20 μm), each of the fragments (chips) is mounted one by one, and the rest is all in the same manner as in Example 7 above, and a fine saccharide needle mounted with a sodium ascorbate chip (schematic diagram of its cross section) Was prepared as shown in FIG. This fine sugar needle was subjected to an insertion test once a day on a part of the facial skin of a female subject (similar to Example 9) for the purpose of skin whitening on the face. As a result of comparative examination by taking a photograph of the skin, a whitening effect was confirmed after 60 days. This is because vitamin C, which is easily decomposed by heating, such as sodium ascorbate phosphate, is partially decomposed by heating in the method according to Example 9, and the whitening effect is somewhat reduced. It was confirmed that if it was made into a chip and mounted on the glucose-coated surface, it did not undergo a heating process and therefore it was not decomposed and the whitening effect could be sufficiently exhibited.
加熱溶解法(80℃に一定加熱後、被溶解物を溶解させる)により、無水非結晶マルトースにアスコルビン酸マグネシウムを2重量%含有させたものを原料素材として用い、それ以外は全て上記実施例7と同様の方法にて、アスコルビン酸マグネシウムを含有した微細糖質針(その外形の概略図は図6の通り)を作製した。この微細糖質針について、顔面におけるしみ取りを目的として、女性被験者(実施例9と同様)の顔の皮膚の一部(しみ部)に1日1回の挿入試験を行ったところ、微細針挿入部位付近における皮膚の写真撮影による比較検討の結果、60日後に顔面の褐色しみが薄まっていることが確認された。 Example 7 In which 7% by weight of anhydrous ascorbate magnesium was added to anhydrous amorphous maltose as a raw material by the heating dissolution method (after constant heating at 80 ° C., dissolution was performed) In the same manner as above, a fine sugar needle containing magnesium ascorbate (a schematic diagram of its outer shape is as shown in FIG. 6) was produced. With respect to this fine sugar needle, an insertion test was conducted once a day on a part (stain part) of the skin of the face of a female subject (similar to Example 9) for the purpose of removing stains on the face. As a result of a comparative examination by photographing the skin in the vicinity of the insertion site, it was confirmed that the brown stain on the face had faded after 60 days.
微細針上面と微細針取付け代上面の両上面にグルコースを、塗布用微細ハケを用いて被覆し、その20ヶ所の被覆面上の各々に、マルトースとプルランの混合素材(混合重量比1:1)にヒトIgG抗体を0.25重量%含有させたものを円板形状(直径50μm、厚さ20μm)に断片(チップ)化したものを1個ずつ搭載させ、それ以外は全て上記実施例7と同様の方法にて、IgG抗体含有チップを搭載した微細糖質針(その外形の断面の概略図は図17の通り)を作製した。この微細糖質針を用いて、ラットの皮膚に投与するIn−Vivo実験を行ったところ、皮膚内にヒトIgG抗体が確認された。この方法により、人への適用試験が可能となった。 Glucose is coated on both upper surfaces of the fine needle upper surface and the fine needle mounting allowance surface using a fine brush for coating, and a mixed material of maltose and pullulan (mixing weight ratio 1: 1) is coated on each of the 20 coated surfaces. ) Containing human IgG antibody in 0.25% by weight in the form of a disc (diameter 50 μm,
加熱溶解法(100℃に一定加熱後、被溶解物を溶解させる)により、無水非結晶マルトースにエストロディオール(ホルモンの一種)を10μg含有させたものを原料素材として用い、それ以外は全て上記実施例7と同様の方法にて、エストロディオールを含有した微細糖質針(その外形の概略図は図6の通り)を作製した。これにより、従来の注射ではμgオーダーのホルモン投与が極めて困難であったものが、ホルモンを含有した微細針の本数を調節することで、精度良く人体へ投薬し得ることが確認された。 Using a raw material that contains 10 μg of estrodiol (a kind of hormone) in anhydrous amorphous maltose by the heat dissolution method (dissolve the material to be dissolved after constant heating at 100 ° C.). In the same manner as in Example 7, a fine sugar needle containing estrodiol (schematic diagram of its outer shape is as shown in FIG. 6) was prepared. As a result, it was confirmed that although it was extremely difficult to administer the hormone in the order of μg by conventional injection, it can be accurately administered to the human body by adjusting the number of fine needles containing the hormone.
加熱溶解法(110℃に一定加熱後、被溶解物を溶解させる)により、無水非結晶マルトースに食用製剤赤色を1重量%含有させたものを原料素材として用い、それ以外は全て上記実施例7と同様の方法にて、上記赤色素を含有した微細糖質針(その外形の概略図は図6の通り)を作製した。この微細糖質針について、安全な刺青が可能か否かを目的として、女性被験者(実施例9と同様)の背中の皮膚の一部に挿入したところ、その皮膚角質層に赤色素が残留し得ることが目視により確認できた。これにより、安全で、かつ簡易な刺青が可能となり、色素を選択することにより、皮膚内へ任意の表記をなし得ることが確認された。 Example 7 In the above-described Example 7 except that 1% by weight of red edible preparation was added to anhydrous amorphous maltose as a raw material by the heat dissolution method (after constant heating at 110 ° C., the material to be dissolved was dissolved). In the same manner as above, a fine sugar needle containing the above red pigment (schematic diagram of its outer shape is as shown in FIG. 6) was prepared. When this fine sugar needle is inserted into a part of the skin of the back of a female subject (similar to Example 9) for the purpose of whether or not safe tattooing is possible, red pigment remains on the skin stratum corneum. It was confirmed visually that it was obtained. As a result, it was confirmed that safe and simple tattooing is possible, and that any notation can be made in the skin by selecting a pigment.
微細針上面と微細針取付け代上面の両上面にグルコースを、塗布用微細ハケを用いて被覆し、その20ヶ所の被覆面上の各々に、ヒアルロン酸を円板形状(直径50μm、厚さ20μm)に断片(チップ)化したものを1個ずつ搭載させ、それ以外は全て上記実施例7と同様の方法にて、ヒアルロン酸チップを搭載した微細糖質針(その断面の概略図は図17の通り)を作製した。この微細糖質針について、顔面における美肌を目的として、女性被験者(実施例9と同様)の顔の皮膚の一部に1日1回の挿入試験を行ったところ、微細針挿入部位付近における皮膚の写真撮影による比較検討の結果、60日後に美肌効果(肌の光沢)が確認された。このことは、ヒアルロン酸のような加熱分解しやすいものでも、本実施例のようにチップ化して上記グルコース被覆面上に搭載させれば、加熱過程を経ることがないので分解せず、美肌効果が十分に発揮し得ることが確認された。 Glucose is coated on both upper surfaces of the fine needle upper surface and the fine needle mounting allowance surface with a fine brush for application, and hyaluronic acid is formed in a disk shape (diameter 50 μm,
微細針上面と微細針取付け代上面の両上面にグルコースを、塗布用微細ハケを用いて被覆し、その20ヶ所の被覆面上の各々に、マルトースにカルテノイド(ビタミンAの一種)を1重量%含有させたものを円板形状(直径50μm、厚さ20μm)に断片(チップ)化したものを1個ずつ搭載させ、それ以外は全て上記実施例7と同様の方法にて、カルテノイドチップを搭載した微細糖質針(その断面の概略図は図17の通り)を作製した。この微細糖質針を用いて、人の上腕の皮膚の一部に投与するIn−Vivo実験を行ったところ、皮膚角質層内に栄養剤であるカルテノイドが残留し得ることが確認された。 Glucose is coated on both upper surfaces of the fine needle upper surface and the fine needle mounting allowance surface using a fine brush for coating, and 1% by weight of carotenoid (a kind of vitamin A) is added to maltose on each of the 20 coated surfaces. Each of the contained elements is mounted in a disk shape (diameter 50 μm,
微細針上面と微細針取付け代上面の両上面にグルコースを、塗布用微細ハケを用いて被覆し、その20ヶ所の被覆面上の各々に、マルトースにインスリンを20重量%含有させたものを円板形状(直径50μm、厚さ20μm)に断片(チップ)化したものを1個ずつ搭載させ、それ以外は全て上記実施例7と同様の方法にて、インスリン含有チップを搭載した微細糖質針(その断面の概略図は図17の通り)を作製した。この微細糖質針を用いて、ラットの皮膚の一部に投与するIn−Vivo実験を行ったところ、皮膚角質層内にインスリンが残留し得ることが確認された。このことは、インスリンのような加熱分解しやすいものでも、本実施例のようにチップ化して上記グルコース被覆面上に搭載させれば、加熱過程を経ることがないので分解せず、インスリンの薬効が人体内でも十分に発揮し得ることが確認された。 Glucose is coated on both upper surfaces of the fine needle upper surface and the fine needle mounting allowance surface using a fine brush for application, and each of the 20 coated surfaces is made of a maltose containing 20% by weight of insulin. Fine sugar needles loaded with insulin-containing chips in the same manner as in Example 7 except that one piece (chip) in a plate shape (diameter 50 μm,
微細針上面と微細針取付け代上面の両上面にグルコースを、塗布用微細ハケを用いて被覆し、その20ヶ所の被覆面上の各々に、コラーゲンを円板形状(直径50μm、厚さ20μm)に断片(チップ)化したものを1個ずつ搭載させ、それ以外は全て上記実施例7と同様の方法にて、コラーゲン含有チップを搭載した微細糖質針(その断面の概略図は図17の通り)を作製した。この微細糖質針を用いて、人の上腕の皮膚の一部に挿入したところ、皮膚角質層内にコラーゲンが残留し得ることが確認された。このことは、蛋白質であるコラーゲンのような加熱分解しやすいものでも、本実施例のようにチップ化して上記グルコース被覆面上に搭載させれば、加熱過程を経ることがないので分解せず、蛋白質を変質させることなく皮膚内に残留させ得ることが確認できた。 Glucose is coated on both upper surfaces of the fine needle upper surface and the fine needle mounting allowance surface using a fine brush for coating, and collagen is formed in a disk shape (diameter 50 μm,
微細針上面と微細針取付け代上面の両上面にグルコースを、塗布用微細ハケを用いて被覆し、その20ヶ所の被覆面上の各々に、マルトースにワクチンを3重量%含有させたものを円板形状(直径50μm、厚さ20μm)に断片(チップ)化したものを1個ずつ搭載させ、それ以外は全て上記実施例7と同様の方法にて、ワクチン含有チップを搭載した微細糖質針(その断面の概略図は図17の通り)を作製した。この微細糖質針を用いて、ラットの皮膚の一部に投与するIn−Vivo実験を行ったところ、皮膚角質層内にワクチンが残留し得ることが確認された。このことは、ワクチンのような加熱分解しやすいものでも、本実施例のようにチップ化して上記グルコース被覆面上に搭載させれば、加熱過程を経ることがないので分解せず、ワクチンの活性度を低下させることなく、皮膚角質層内でワクチンを残留させ得ることが確認された。 Glucose is coated on both upper surfaces of the fine needle upper surface and the fine needle mounting allowance surface with a fine brush for application, and each of the 20 coated surfaces is made of a circle containing 3% by weight of maltose vaccine. Fine saccharide needles loaded with vaccine-containing chips in the same manner as in Example 7 except that one piece (chip) in a plate shape (diameter 50 μm,
本発明の微細糖質針、その製造方法及び製造装置は前述の種々の特徴的効果を有するが、これらにより、医療分野、美容分野、化粧分野において利用できる。また、本発明の微細糖質針は、本発明の製造法方法及び製造装置により量産が可能であり、産業上利用できるものである。 The fine sugar needle, the production method and the production apparatus of the present invention have the above-mentioned various characteristic effects, and can be used in the medical field, the beauty field, and the cosmetic field. The fine sugar needle of the present invention can be mass-produced by the production method and apparatus of the present invention and can be used industrially.
1 微細糖質針
2 基板
3 接着部位
4 薬剤チップ
5 微細針
6 基板上面側端部に溶接された微細針取付け代
7 基板上面食い込み部に溶接された微細針取付け代
8 微細針部位(波線状円内)
9 複数層からなる基板
10 グルコース被覆面
11 重石部品又は圧力板である圧力機構
12 圧力方向を示す矢印
13 掃引ヘラである掃引機構
14 掃引方向を示す矢印
15 回転ローラ
16 回転ローラの移動方向を示す矢印
17 回転ローラによる巻きシート
18 回転ローラの掃引方向を示す矢印
19 針先端部から針底面部までの垂線長
20 針底面部横幅
21 針底面部縦幅DESCRIPTION OF
9 Substrate consisting of
Claims (21)
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