JP2010069270A - Device for administration of functional medicine and method and apparatus for manufacturing the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To solve the problem that conventionally, in the administration of a tonic or a medicinal medicine by an intravenous drip, a skin injury is likely to occur since an injection needle is used, especially when the intravenous drip is repeatedly performed, a skin injury section spreads too much and puts excessive corporal and mental burdens on a patient, and the development of a new means and a new method for the administration of the tonic, etc. which can replace the intravenous drip, is an important problem, and moreover, in the case of applying the technique of a conventional fine carbohydrate needle as the administration means of those, etc., and the way for embodying is a very important subject. <P>SOLUTION: In the device for administration of functional medicine, since maltose or carbohydrate containing the tonic and a medicinal medicine is used as the principal component of the carbohydrate of the fine carbohydrate needle and furthermore the fine carbohydrate needle is in a minute form, the carbohydrate of the fine carbohydrate needle, which remains on the inside of the skin, dissolves and becomes the tonic and the transdermal administration of the tonic, etc. can be simply and continuously carried out in the state of analgesia, and moreover, because of a manufacturing method which produces the fine carbohydrate needle on a mount in predetermined conditions, an effect capable of manufacturing it with high accuracy, at a low cost, and in a simple way is provided. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

本発明は、人体に栄養剤や医薬剤を経皮投与することを目的とする機能剤投与デバイス、その製造方法及び製造装置に関するものである。また本発明は、機能剤投与デバイスの主要部である糖質を主成分とする微細針、すなわち微細糖質針自体が栄養剤としての機能を有し、その微細糖質針による栄養剤の経皮投与技術に関するものである。さらに本発明は、その微細糖質針の糖質に医薬剤を含有させて人体に投与する医薬剤の経皮投与技術に関するものである。  The present invention relates to a functional agent administration device for the purpose of transdermally administering a nutrient or a pharmaceutical agent to the human body, a method for producing the device, and a production apparatus. The present invention also provides a fine needle mainly composed of a saccharide, which is a main part of the functional agent administration device, that is, the fine saccharide needle itself has a function as a nutrient, and the nutrition of the nutrient by the fine saccharide needle. It relates to the skin administration technology. Furthermore, the present invention relates to a transdermal administration technique of a pharmaceutical agent that is administered to a human body by containing the pharmaceutical agent in the carbohydrate of the fine sugar needle.

従来、人体への栄養剤や医薬剤投与の安全な代表的手段は、人がベッドに横たわって行う輸液化した栄養剤や医薬剤の点滴であった。しかし、災害時や事故時等ならびに過度なスポーツによる疲労時において、現場では点滴器具等がないにしても、その応急処置として早急に栄養剤や医薬剤の迅速投与が必要なことが各メディア等で大きく報じられている。  Conventionally, a safe representative means of administration of nutrients and pharmaceutical agents to the human body has been infusion of infused nutrients and pharmaceutical agents performed by a person lying on a bed. However, in the event of a disaster or accident, or during fatigue due to excessive sports, even if there is no infusion device etc. on site, it is necessary to promptly administer nutrients and pharmaceuticals as an emergency measure. It is reported greatly in.

このような社会的ニーズを背景として、近年においては微細糖質針の製造技術が進展し、応用面での発展も伴い、新たな試みであるが、点滴の代用として微細糖質針の技術が応用できるか否かが問われていた。ただし、微細糖質針が栄養剤等を投与できる量には限界があるので、必要な栄養剤等投与量の確保を可能とするデバイスが求められていた。この投与量の確保には複数の微細針を設けることによって解決できるのであるが、その際には量産化によるコスト低減を可能とする技術の開発が重要となる。  Against the background of such social needs, in recent years, the manufacturing technology of fine sugar needles has progressed, and with the development in application, it is a new attempt. It was questioned whether it could be applied. However, since there is a limit to the amount of fine sugar needles that can administer nutrients and the like, there has been a demand for a device that can secure the necessary dose of nutrients and the like. The securing of this dose can be solved by providing a plurality of fine needles, but in that case, it is important to develop a technology that enables cost reduction by mass production.

かかる微細糖質針の量産化技術の開発において、従来の引き伸ばし方式を用いた生分解性物質（マルトースを主成分材料とする）からなる皮膚用針の製造では、加熱溶融した主成分材料を微細なノズルより押し出し、押し出された微細な主成分材料部分を基板（紙、テープ、プラスティック性又は金属性シート等）に付着させた後、その部分を引き伸ばすことにより、一個々々ごとに皮膚用針を製造する方法及び装置（例えば、特許文献１参照）が提供されている。
再公表特許（Ａ１） ＪＰ ＷＯ２００６／０７７７４２号公報 In the development of mass production technology for such fine sugar needles, in the manufacture of skin needles made of biodegradable substances (with maltose as the main ingredient) using a conventional stretching method, the heat-melted main ingredient is finely divided. After extruding from a simple nozzle, and attaching the extruded fine main component material part to a substrate (paper, tape, plastic or metal sheet, etc.), the part is stretched to make a needle for each skin individually. A method and apparatus (see, for example, Patent Document 1) are provided.
Republished patent (A1) JP WO2006 / 077742

一般に、栄養剤等の補給手段としては経口投与が中心であるが、経口投与が困難な場合は、静脈に打つ点滴によって栄養剤を投与するが、注射針を使って静脈点滴を行うので、注射針の傷による皮膚表面の損傷が起こり、点滴による栄養剤投与を繰り返し何度も施行すると、皮膚表面の損傷部位が大きく広がりすぎて、患者に過度の肉体的かつ精神的負担をかけることになり、また点滴自体の続行が極めて困難となり、このことが点滴の大きな問題であった。そこで、このような点滴の問題を克服するべく、点滴に代わり得る新たな手段、方法の開発が課題となっており、特に従来の微細糖質針の技術を如何にして応用するかが喫緊の課題でもあった。  Generally, oral administration is the main means of supplementing nutrients, etc., but when oral administration is difficult, nutrients are administered by intravenous infusion, but intravenous infusion is performed using a syringe needle. If the skin surface is damaged by a needle wound, and repeated administration of nutrients by instillation is repeated many times, the damaged part of the skin surface will spread too much, putting an excessive physical and mental burden on the patient. In addition, it was extremely difficult to continue the infusion itself, which was a big problem with infusion. Therefore, in order to overcome such drip problems, the development of new means and methods that can replace drip has become an issue, and it is particularly urgent how to apply the technology of conventional fine sugar needles. It was also an issue.

従来の多数の微細糖質針を基板上に立設する場合では、上記の特許文献１に記載されているように、基板は粘着性のあるもので耐熱性及び伸縮性を有した、紙、テープ、プラスティック性又は金属性シート等が使用されていたので、微細糖質針の基板への接着強度は十分ではなく、その為に微細糖質針が基板から脱落し易くなったり、皮膚挿入時に折れ易くなったりし、製品歩留りは低迷することとなり、この問題を解決する手段の開発が課題となっていた。  In the case where many conventional fine sugar needles are erected on a substrate, as described in Patent Document 1 above, the substrate is sticky and has heat resistance and stretchability, Since tape, plastic or metal sheets were used, the adhesion strength of the fine sugar needle to the substrate was not sufficient, which made it easy for the fine sugar needle to come off the substrate, or when inserting the skin The product yield tends to be sluggish, and the development of means for solving this problem has been an issue.

また、従来、基板上に糖質微細針を直接設けるため、ノズルより加熱溶融した糖質材をノズルより押し出し、押し出された微細な糖質材部分を基板に接着し、ノズルを基板より徐々に引き離すことにより、すなわち糖質材部分を引き伸ばすことにより基板上に微細糖質針を立設したが、加熱溶融した糖質材を押し出す微細なノズルは極めて精密に加工する必要があるため、コンピュータ制御によるノズル加工、ノズルからの押し出し量制御及びノズルの移動制御を含めると高価な製造装置となり、その分コスト高の要因となった。また、複数の微細糖質針を基板上に立設するには、同数のノズルを必要とするため、さらにコスト高を招く要因ともなった。さらに複数のノズルは、個々のノズル差から現れるノズル間のバラツキが、微細糖質針のバラツキになり、量産化あるいは均一化における阻害要因ともなった。従って、これらの問題を解決する手段の開発が課題であった。  Also, conventionally, since a saccharide fine needle is directly provided on a substrate, the saccharide material heated and melted from the nozzle is extruded from the nozzle, the extruded fine saccharide material portion is adhered to the substrate, and the nozzle is gradually moved from the substrate. The fine sugar needles were erected on the substrate by pulling them apart, that is, by extending the sugar material part, but the fine nozzle that pushes the heated and melted sugar material needs to be processed with great precision, so computer control Including the nozzle processing by the nozzle, the extrusion amount control from the nozzle, and the movement control of the nozzle, it becomes an expensive manufacturing apparatus, which causes a high cost. In addition, since the same number of nozzles are required to stand a plurality of fine saccharide needles on the substrate, it is a factor that further increases the cost. Furthermore, among the plurality of nozzles, the variation between the nozzles that appears due to the difference between the individual nozzles became the variation of the fine sugar needles, which became an obstacle to mass production or homogenization. Therefore, the development of means for solving these problems has been an issue.

さらには、栄養剤等の経皮投与量を確保するために従来の微細糖質針の本数を増やす構造をとる場合、同数のノズルを必要とするが、ノズル外形の微細化限界に起因して、ノズル領域確保のため基板上において単位面積当りの微細糖質針の個数密度（集積度）に限界があり、このことも解決すべき課題となっていた。  Furthermore, when taking a structure that increases the number of conventional fine sugar needles to secure the transdermal dosage of nutrients, etc., the same number of nozzles is required, but due to the limit of miniaturization of the nozzle outer shape. In order to secure the nozzle area, there is a limit to the number density (integration degree) of fine sugar needles per unit area on the substrate, which is also a problem to be solved.

また、従来の多数の微細糖質針を基板上に設ける場合、コストを抑えるため、単一ノズルのみで、各針を設ける位置に移動しながら微細針を設け、多数の糖質針を形成する方法もあるが、移動機構付加および移動時間がかさみ、生産効率に限界が生じ、この分のコスト高は無視できず、この問題を解決する手段の開発も課題であった。  In addition, when a large number of conventional fine sugar needles are provided on a substrate, in order to reduce costs, a single needle is used to provide a fine needle while moving to the position where each needle is provided, thereby forming a large number of sugar needles. Although there is a method, the addition of the moving mechanism and the moving time are increased, and the production efficiency is limited. The high cost is not negligible, and the development of a means for solving this problem has been an issue.

次に、従来のノズルによる引き伸ばし方式では、ノズル部と基板設置部の２箇所に加熱用ヒータを設ける必要があり、装置規模の温度制御機構を２箇所必要とするので、装置が複雑で装置規模も大きくなり、コスト面で不利となった。また、複数のノズルを設ける場合は、その数だけ温度制御機構を必要とし、さらにコスト高を導くこととなり、これらの問題を解決する手段の開発も重要課題となっていた。  Next, in the conventional stretching method using a nozzle, it is necessary to provide heating heaters at two locations, the nozzle portion and the substrate placement portion, and two temperature control mechanisms for the device scale are required. Also, the cost was disadvantageous. Further, when a plurality of nozzles are provided, the number of temperature control mechanisms is required, which leads to higher costs, and the development of means for solving these problems has become an important issue.

前述の様々な課題を解決するべく、本発明者らは鋭意研究開発を行ったところ、本発明においては、これらの課題を解決するための手段、方法として、
（１）多糖類からなる基板上に、台座高さ１０μｍ〜２ｍｍ、台座上面の直径３０μｍ〜１ｍｍ、前記基板と接する台座底面の直径４０μｍ〜１．５ｍｍである略円柱形状の多糖類からなる台座を複数個設け、前記台座上に、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、前記台座上面と接する針底面の直径３０μｍ〜１ｍｍである略円錐形状又は釣鐘形状の微細糖質針を設けた構造であることを特徴とする機能剤投与デバイス、並びに、
（２）多糖類からなる基板上に、台座高さ１０μｍ〜２ｍｍ、台座上面の直径３０μｍ〜１ｍｍ、前記基板と接する台座底面の直径４０μｍ〜１．５ｍｍである略円柱形状の多糖類からなる台座を複数個設け、前記台座上に、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、前記台座上面と接する針底面の直径３０μｍ〜１ｍｍ、針長さ方向における略中間部の最大直径が５０μｍ〜１．５ｍｍである宝珠形状の微細糖質針を設けた構造であることを特徴とする機能剤投与デバイス、並びに、
（３）多糖類からなる基板上に、台座高さ１０μｍ〜２ｍｍ、台座上面が直径３０μｍ〜１ｍｍの円に内接又は外接し、前記基板と接する台座底面が直径４０μｍ〜１．５ｍｍの円に内接又は外接する略多角柱形状の多糖類からなる台座を複数個設け、前記台座上に、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、針底面が該台座上面と同一形状である略多角錐形状又は略釣鐘形状の微細糖質針を設けた構造であることを特徴とする機能剤投与デバイス、並びに、
（４）多糖類からなる基板上に、台座高さ１０μｍ〜２ｍｍ、台座上面が直径３０μｍ〜１ｍｍの円に内接又は外接し、前記基板と接する台座底面が直径４０μｍ〜１．５ｍｍの円に内接又は外接する略多角柱形状の多糖類からなる台座を複数個設け、前記台座上に、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、針底面が該台座上面と同一形状で、針長さ方向における略中間部が直径５０μｍ〜１．５ｍｍの円に内接又は外接する略多角形である略宝珠形状の微細糖質針を設けた構造であることを特徴とする機能剤投与デバイス、並びに、
（５）前記多糖類がプルラン又はカルボキシメチルセルロースであり、前記微細糖質針の糖質がマルトースであることを特徴とする前記（１）から（４）いずれか記載の機能剤投与デバイス、並びに、
（６）前記多糖類がプルラン又はカルボキシメチルセルロースであり、前記微細糖質針の糖質が主成分をマルトースとし、他成分をグルコース又はトレハロースとする糖質混合物であることを特徴とする前記（１）から（４）いずれか記載の機能剤投与デバイス、並びに、
（７）前記微細糖質針の糖質に、ビタミンＡ、ビタミンＢ複合体、ビタミンＣ、ビタミンＤ、ビタミンＥ、ビタミンＫ、グルタミン、必須アミノ酸、非必須アミノ酸、γ−アミノ酪酸、タウリン、脂肪酸、核酸、アドレナリン、から選択される１又は２以上の栄養剤を含有させたことを特徴とする前記（５）又は（６）記載の機能剤投与デバイス、並びに、
（８）前記微細糖質針の糖質に、鎮痛薬剤、消炎薬剤、解熱鎮痛消炎薬剤、抗真菌剤、抗菌剤、抗ウィルス薬、強心薬、血栓溶解剤、止血剤、利尿薬、高血圧治療薬、麻酔剤、鎮静剤、睡眠薬、抗痙攣薬、抗不安薬、酔い止め薬、精神安定剤、抗うつ剤、睡眠鎮静剤、抗原虫薬剤、から選択される１の医薬剤を含有させたことを特徴とする前記（５）又は（６）記載の機能剤投与デバイス、並びに、
（９）前記多糖類からなる基板上に、金型成型による前記多糖類からなる台座を複数個成形した後、昇降制御機構を有し水平面に沿うステージに、前記基板を前記台座が鉛直下向き方向を指すように取り付け、前記台座上面を静置状態の９０℃〜１２０℃に温度制御された糖質加熱容器内の溶融した前記糖質の上面に接触させた後、前記ステージを昇降させることにより前記台座上面に前記微細糖質針を成形することを特徴とする前記（１）から（８）いずれか記載の機能剤投与デバイスの製造方法、並びに、
（１０）前記多糖類からなる基板上に、金型成型による前記多糖類からなる台座を複数個成形した後、昇降制御機構を有し水平面に沿うステージに、前記基板を前記台座が鉛直下向き方向を指すように取り付け、前記台座上面を静置状態の９０℃〜１２０℃に温度制御された糖質加熱容器内の溶融した前記糖質の上面に接触させた後、前記ステージを昇降させることにより前記台座上面に前記微細糖質針を成形することを特徴とする機能剤投与デバイスの製造方法による前記（１）から（８）いずれか記載の機能剤投与デバイス、並びに、
（１１）前記ステージの昇降移動距離をデジタル式に微小に区切り、前記昇降移動距離を任意に変更して前記ステージ昇降の移動速度を微調整する制御方法により、前記台座上面に前記微細糖質針を高精度に成形することを特徴とする前記（９）記載の機能剤投与デバイスの製造方法、並びに、
（１２）前記（９）記載の機能剤投与デバイスの製造方法において、前記ステージの昇降移動距離をデジタル式に微小に区切り、前記昇降移動距離を任意に変更して前記ステージ昇降の移動速度を微調整する制御方法により、前記台座上面に前記微細糖質針を高精度に成形することを特徴とする機能剤投与デバイスの製造方法による前記（１）から（８）いずれか記載の機能剤投与デバイス、並びに、
（１３）前記機能剤投与デバイスの製造装置において、９０℃〜１２０℃の温度制御機構を有する糖質加熱容器、及び前記基板を前記台座が鉛直下向き方向を指すように取付けることが可能な昇降制御機構を有する水平面に沿うステージであり、更に前記台座上面と溶融した前記糖質の上面との距離を任意に位置決めする位置合わせ制御機構を有する前記ステージ、から構成されることを特徴とする前記（１）から（８）いずれか記載の機能剤投与デバイスの製造装置、
としたものである。In order to solve the various problems described above, the present inventors have conducted extensive research and development.In the present invention, as means and methods for solving these problems,
(1) A pedestal made of a substantially cylindrical polysaccharide having a pedestal height of 10 μm to 2 mm, a pedestal top surface diameter of 30 μm to 1 mm, and a pedestal bottom surface diameter of 40 μm to 1.5 mm on the substrate made of polysaccharide. On the pedestal, a substantially conical or bell-shaped fine sugar having a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, and a needle bottom surface diameter of 30 μm to 1 mm in contact with the pedestal top surface A functional agent administration device characterized by having a structure provided with a needle, and
(2) A pedestal made of a substantially cylindrical polysaccharide having a pedestal height of 10 μm to 2 mm, a pedestal top surface diameter of 30 μm to 1 mm, and a pedestal bottom surface diameter of 40 μm to 1.5 mm on the substrate made of polysaccharide. And a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, a needle bottom surface diameter of 30 μm to 1 mm in contact with the top surface of the needle, and a maximum at the middle part in the needle length direction. A functional agent administration device characterized by having a structure provided with a jewel-shaped fine sugar needle having a diameter of 50 μm to 1.5 mm, and
(3) On a substrate made of polysaccharide, a pedestal height of 10 μm to 2 mm, a pedestal top surface is inscribed or circumscribed in a circle with a diameter of 30 μm to 1 mm, and a pedestal bottom surface in contact with the substrate is a circle with a diameter of 40 μm to 1.5 mm A plurality of pedestals made of a substantially polygonal-pillar-shaped polysaccharide that is inscribed or circumscribed are provided. On the pedestal, a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, and a needle bottom surface are the same as the top surface of the pedestal A functional agent administration device, characterized in that it is a structure provided with a fine saccharide needle having a substantially polygonal pyramid shape or a substantially bell-shaped shape, and
(4) On a substrate made of polysaccharide, a pedestal height of 10 μm to 2 mm, a pedestal top surface is inscribed or circumscribed in a circle with a diameter of 30 μm to 1 mm, and a pedestal bottom surface in contact with the substrate is a circle with a diameter of 40 μm to 1.5 mm A plurality of pedestals made of a substantially polygonal-pillar-shaped polysaccharide that is inscribed or circumscribed are provided. On the pedestal, a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, and a needle bottom surface are the same as the top surface of the pedestal The shape is a structure in which an approximately pearl-shaped fine sugar needle having a substantially polygonal shape that is inscribed or circumscribed to a circle having a diameter of 50 μm to 1.5 mm is provided in a substantially middle portion in the needle length direction. Functional agent administration device, and
(5) The functional agent administration device according to any one of (1) to (4), wherein the polysaccharide is pullulan or carboxymethylcellulose, and the sugar of the fine sugar needle is maltose, and
(6) The polysaccharide as described above, wherein the polysaccharide is pullulan or carboxymethylcellulose, and the carbohydrate of the fine sugar needle is a carbohydrate mixture containing maltose as a main component and glucose or trehalose as another component. ) To (4) any one of the functional agent administration devices, and
(7) Carbohydrates of the fine sugar needles include vitamin A, vitamin B complex, vitamin C, vitamin D, vitamin E, vitamin K, glutamine, essential amino acid, non-essential amino acid, γ-aminobutyric acid, taurine, fatty acid A functional agent administration device according to (5) or (6) above, which contains one or more nutrients selected from nucleic acids, adrenaline, and
(8) To the sugar of the fine saccharide needle, analgesic agent, anti-inflammatory agent, antipyretic analgesic anti-inflammatory agent, antifungal agent, antibacterial agent, antiviral agent, cardiotonic agent, thrombolytic agent, hemostatic agent, diuretic agent, hypertension treatment 1 pharmaceutical agent selected from drugs, anesthetics, sedatives, sleeping pills, anticonvulsants, anti-anxiety drugs, sickness medicines, tranquilizers, antidepressants, sleep sedatives, antiprotozoal drugs The functional agent administration device according to (5) or (6) above, and
(9) After forming a plurality of pedestals made of the polysaccharide by mold molding on the substrate made of the polysaccharide, the pedestal is placed in a vertically downward direction on a stage having a lift control mechanism along a horizontal plane. By attaching the upper surface of the pedestal to the upper surface of the molten saccharide in the saccharide heating container whose temperature is controlled to 90 ° C. to 120 ° C. in a stationary state, and then raising and lowering the stage The method for producing a functional agent administration device according to any one of (1) to (8), wherein the fine sugar needle is molded on the pedestal upper surface, and
(10) After forming a plurality of pedestals made of the polysaccharide by die molding on the substrate made of the polysaccharide, the pedestal is placed in a vertically downward direction on a stage having a lifting control mechanism and along a horizontal plane. By attaching the upper surface of the pedestal to the upper surface of the molten saccharide in the saccharide heating container whose temperature is controlled to 90 ° C. to 120 ° C. in a stationary state, and then raising and lowering the stage The functional agent administration device according to any one of (1) to (8) according to the method for producing a functional agent administration device, wherein the fine sugar needle is formed on the pedestal upper surface, and
(11) The fine sugar needle is placed on the upper surface of the pedestal by a control method in which the up / down movement distance of the stage is minutely divided digitally, and the up / down movement distance is arbitrarily changed to finely adjust the movement speed of the stage up / down movement. Is produced with high accuracy, and the method for producing a functional agent administration device according to (9) above, and
(12) In the method for manufacturing a functional agent administration device according to (9), the moving distance of the stage is finely divided in a digital manner, and the moving speed of the moving of the stage is reduced by arbitrarily changing the moving distance. The functional agent administration device according to any one of (1) to (8) according to the method for producing a functional agent administration device, wherein the fine sugar needle is formed on the pedestal upper surface with high accuracy by an adjustment control method. As well as
(13) In the manufacturing apparatus of the functional agent administration device, the carbohydrate heating container having a temperature control mechanism of 90 ° C. to 120 ° C., and the elevation control capable of attaching the substrate so that the pedestal points in the vertically downward direction A stage along a horizontal plane having a mechanism, and further comprising the stage having an alignment control mechanism for arbitrarily positioning a distance between the upper surface of the pedestal and the upper surface of the molten saccharide. 1) to (8) a device for producing a functional agent administration device according to any one of
It is what.

本発明の機能剤投与デバイスにおいては、点滴による応急処置が必要なとき、本発明における微細糖質針を点滴の代用として皮膚に挿入した場合、容易に皮膚内に挿入し、かつ前記台座上面及び前記針底面の接触部近傍で微細糖質針が容易に折れて皮膚内に残留し、皮膚内部に残留した微細糖質針自体が栄養剤や医薬剤となり、消化器官を通さずに栄養剤等を患部に無痛状態で簡易的に投与することが可能となり、患者への肉体的かつ精神的負担を大きく低減することができた。また、本発明の機能剤投与デバイスにおける微細糖質針は、糖質針自体が微小なため、皮膚を損傷させたり、変形させたりすることもなく、皮膚に対して継続して使用することが可能となった。さらには、本発明の機能剤投与デバイスにおいては、微細糖質針の糖質に他の栄養剤や医薬剤を容易に含有させることもでき、このことにより本機能剤投与デバイスの機能性において自由度を大きく向上させ得たものである。  In the functional agent administration device of the present invention, when an emergency treatment by infusion is required, when the fine sugar needle of the present invention is inserted into the skin as a substitute for infusion, it is easily inserted into the skin, and the upper surface of the pedestal and The fine sugar needle easily breaks in the vicinity of the contact portion on the bottom surface of the needle and remains in the skin, and the fine sugar needle remaining in the skin itself becomes a nutrient or a pharmaceutical agent. Can be easily and painlessly administered to the affected area, and the physical and mental burden on the patient can be greatly reduced. Further, the fine sugar needle in the functional agent administration device of the present invention can be continuously used on the skin without damaging or deforming the skin because the sugar needle itself is minute. It has become possible. Furthermore, in the functional agent administration device of the present invention, other nutrients and pharmaceutical agents can be easily contained in the carbohydrate of the fine saccharide needle, thereby freeing the functionality of the functional agent administration device. The degree can be greatly improved.

本発明の機能剤投与デバイスにおいては、微細糖質針を基板上に直接に設けることをせず、多糖類からなる基板上に多糖類からなる台座を複数個設け、各々の台座上に一個ずつ微細糖質針を設けることにより、高い溶接性を有する多糖類と糖質との高接着性の為、微細糖質針の台座への接着が強力なものとなり、微細糖質針の製品歩留まりを向上させることが可能となった。また、従来、微細糖質針の形状は主として円錐形状や多角錐形状であり、これでは栄養剤や医薬剤等の投与量に制限があったが、本発明では釣鐘形状、宝珠形状、またそれらの略形状をも採用することにより、栄養剤等の投与量を大きく増加させることが可能となった。  In the functional agent administration device of the present invention, without providing the fine sugar needles directly on the substrate, a plurality of pedestals made of polysaccharides are provided on the substrate made of polysaccharides, one on each pedestal. By providing a fine sugar needle, the high adhesion between the polysaccharide and sugar with high weldability, the adhesion of the fine sugar needle to the pedestal becomes strong, and the product yield of the fine sugar needle is increased. It became possible to improve. In addition, conventionally, the shape of the fine sugar needle is mainly a cone shape or a polygonal pyramid shape, and there has been a limit to the dosage of nutrients, pharmaceutical agents, etc., but in the present invention, a bell shape, a jewel shape, By adopting this general shape, it has become possible to greatly increase the dose of nutrients and the like.

本発明の機能剤投与デバイスの製造方法においては、前記多糖類からなる基板上に、金型成型による前記多糖類からなる台座を複数個成形した後、昇降制御機構を有し水平面に沿うステージに、前記基板を前記台座が鉛直下向き方向を指すように取り付け、前記台座上面を静置状態の９０℃〜１２０℃に温度制御された糖質加熱容器内の溶融した前記糖質の上面に接触させた後、前記ステージを昇降させることにより前記台座上面に前記微細糖質針を成形することとしたため、従来の引き伸ばし方式で必要なノズル機構を一切必要とせず、このことにより大幅なコスト低減が可能となった。また、前記基板に設けた微細な前記台座は、金型によって成形するので、台座間のバラツキは金型のバラツキ程度に十分小さく抑えることができ、１回の前記ステージの昇降による微細糖質針の成形につき、多数の微細糖質針を同時並行に成形することが可能となり、微細糖質針の均一化、量産化を成し得たものである。尚、本発明においては、微細等質針の針底面が該台座上面と同一形状であることになるが、これは該台座上面に溶接された溶融糖質材を前記ステージの昇降により引き伸ばして微細糖質針を成形することに起因するものである。  In the method for producing a functional agent administration device of the present invention, a plurality of pedestals made of the polysaccharide by molding are formed on the substrate made of the polysaccharide, and then a stage along the horizontal plane having an elevation control mechanism. The substrate is attached so that the pedestal points in a vertically downward direction, and the upper surface of the pedestal is brought into contact with the upper surface of the molten saccharide in a saccharide heating container whose temperature is controlled at 90 ° C. to 120 ° C. in a stationary state. After that, the fine sugar needle is formed on the pedestal upper surface by moving the stage up and down, so there is no need for the nozzle mechanism necessary for the conventional stretching method, and this can greatly reduce the cost. It became. In addition, since the fine pedestal provided on the substrate is molded by a mold, the variation between the pedestals can be suppressed to a sufficiently small degree of variation of the mold, and the fine saccharide needle by raising and lowering the stage once. As a result of this molding, a large number of fine sugar needles can be molded simultaneously in parallel, and the fine sugar needles can be made uniform and mass-produced. In the present invention, the bottom surface of the fine homogeneous needle has the same shape as the top surface of the pedestal. This is because the molten saccharide material welded to the top surface of the pedestal is stretched by raising and lowering the stage. This is caused by molding a sugar needle.

本発明の機能剤投与デバイスにおいては、栄養剤や医薬剤の投与量を確保するため微細糖質針の本数を増やす構造をとるが、金型により複数の台座を高精度に作製できるので、台座は金型の製作の高精度化によって、基板面上の台座について単位面積あたりの個数密度を上げて成形することでき、これにより微細糖質針の基板単位面積あたりの個数密度が高い高集積化構造をとることが可能となった。  The functional agent administration device of the present invention has a structure in which the number of fine sugar needles is increased in order to ensure the dosage of a nutritional agent or a pharmaceutical agent, but since a plurality of pedestals can be produced with high precision by a mold, the pedestal Can be molded by increasing the number density per unit area of the pedestal on the substrate surface by increasing the precision of the mold production, thereby increasing the number density of the fine sugar needles per unit area of the substrate It became possible to take the structure.

本発明の機能剤投与デバイスの製造方法においては、基板上に成形された複数の台座上に微細糖質針を設ける方式を採用しているため、糖質加熱部は前記糖質を加熱溶融させるために１箇所のみに収めることができるので、装置構造の簡略化が図れ、大幅なコスト低減化を可能とした。  In the method for producing a functional agent administration device of the present invention, since a method in which fine sugar needles are provided on a plurality of pedestals formed on a substrate is adopted, the sugar heating unit heats and melts the sugar. Therefore, since it can be accommodated in only one place, the structure of the apparatus can be simplified and the cost can be greatly reduced.

本発明の機能剤投与デバイスを点滴の代用として患者に使用した場合、すなわち患者の皮膚へ微細糖質針を挿入した場合、皮膚内部に残留した微細糖質針自体が栄養剤や医薬剤となり、栄養剤等を患部に無痛状態で簡易的に投与でき、患者への肉体的かつ精神的負担を大きく低減することができるという効果が得られた。また、本発明の機能剤投与デバイスにおける微細糖質針は、糖質針自体が微小なため、皮膚を損傷させたり、変形させたりすることもなく、皮膚に対して継続して使用できるという効果も得られた。さらには、本発明の機能剤投与デバイスにおいては、微細糖質針の糖質に他の栄養剤や医薬剤を容易に含有させることもでき、このことにより本機能剤投与デバイスの機能性において自由度を大きく増加させ得るという効果をも得られた。  When the functional agent administration device of the present invention is used for a patient as a substitute for infusion, that is, when a fine sugar needle is inserted into the patient's skin, the fine sugar needle remaining in the skin itself becomes a nutrient or a pharmaceutical agent, It was possible to easily administer nutrients and the like to the affected area in a painless state, and the physical and mental burden on the patient could be greatly reduced. In addition, the fine sugar needle in the functional agent administration device of the present invention has an effect that it can be continuously used on the skin without damaging or deforming the skin because the sugar needle itself is minute. Was also obtained. Furthermore, in the functional agent administration device of the present invention, other nutrients and pharmaceutical agents can be easily contained in the carbohydrate of the fine saccharide needle, thereby freeing the functionality of the functional agent administration device. The effect that the degree can be greatly increased was also obtained.

本発明の機能剤投与デバイスにより、多糖類からなる基板上に多糖類からなる台座を複数個設け、各々の台座上に一個ずつ微細糖質針を設けることによって、高い溶接性を有する多糖類と糖質との高接着性の為、微細糖質針の台座への接着が強力なものとなり、微細糖質針の製品歩留りを向上させ得るという効果が得られた。また、本発明では釣鐘形状、宝珠形状、またそれらの略形状をも採用することにより、栄養剤等の投与量を飛躍的に増加させ得るという効果も得られた。  By providing a plurality of pedestals made of polysaccharides on a substrate made of polysaccharides by using the functional agent administration device of the present invention, and providing a fine saccharide needle one by one on each pedestal, a polysaccharide having high weldability and Due to the high adhesion to sugar, the adhesion of the fine sugar needle to the pedestal became strong, and the effect of improving the product yield of the fine sugar needle was obtained. Moreover, in this invention, the effect that the dosage of nutrients etc. can be increased dramatically was also acquired by adopting a bell shape, a jewel shape, and those approximate shapes.

本発明の機能剤投与デバイスの製造方法では、前記多糖類からなる基板上に、金型成型による前記多糖類からなる台座を複数個成形した後、昇降制御機構を有し水平面に沿うステージに、前記基板を前記台座が鉛直下向き方向を指すように取り付け、前記台座上面を静置状態の９０℃〜１２０℃に温度制御された糖質加熱容器内の溶融した前記糖質の上面に接触させた後、前記ステージを昇降させることにより前記台座上面に前記微細糖質針を成形することとしたため、大幅にコスト低減し得るという効果が得られた。また、本発明の製造方法では、１回の前記ステージの昇降による微細糖質針の成形につき、多数の微細糖質針を同時並行に成形することが可能となり、微細糖質針の均一化、量産化を成し得るという効果をもたらせた。  In the method for producing a functional agent administration device of the present invention, on the substrate made of the polysaccharide, after forming a plurality of pedestals made of the polysaccharide by mold molding, on the stage along the horizontal plane having an elevation control mechanism, The substrate was attached so that the pedestal points in a vertically downward direction, and the upper surface of the pedestal was brought into contact with the upper surface of the molten saccharide in a saccharide heating container whose temperature was controlled at 90 ° C. to 120 ° C. in a stationary state. Thereafter, the fine sugar needle was formed on the upper surface of the pedestal by moving the stage up and down, so that the effect of significantly reducing the cost was obtained. Further, in the production method of the present invention, it becomes possible to simultaneously mold a large number of fine sugar needles for forming a fine sugar needle by raising and lowering the stage once, It was possible to achieve mass production.

本発明の機能剤投与デバイスでは、金型により複数の台座を高精度に作製できるので、台座は金型の製作の高精度化によって、基板面上の台座について単位面積あたりの個数密度を上げて成形することでき、これにより微細糖質針の基板単位面積あたりの個数密度が高い高集積化構造をとり得るという効果が得られた。  In the functional agent administration device of the present invention, since a plurality of pedestals can be produced with high precision by using a mold, the number of pedestals on the substrate surface can be increased by increasing the number density per unit area by making the molds highly accurate. As a result, it was possible to obtain a highly integrated structure in which the number density of fine sugar needles per substrate unit area was high.

本発明の機能剤投与デバイスの製造方法では、基板上に成形された複数の台座上に微細糖質針を設ける方式を採用しているため、糖質加熱部は前記糖質を加熱溶融させるために１箇所のみに収めることができ、装置構造の簡略化が図れ、大幅なコスト低減化をなし得るという効果をも得られた。  In the method for producing a functional agent administration device of the present invention, a method in which fine saccharide needles are provided on a plurality of pedestals formed on a substrate is employed, so that the saccharide heating unit heats and melts the saccharide. Thus, the device structure can be simplified and the cost can be greatly reduced.

本発明の機能剤投与デバイス、その製造方法及び製造装置の実施形態について以下に詳述するが、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。  Embodiments of the functional agent administration device, the production method thereof, and the production apparatus of the present invention will be described in detail below, 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、機能剤とは栄養剤又は医薬剤を意味するものであり、また機能剤投与デバイスとは微細糖質針の皮膚内挿入、残留後の皮膚内溶解により、栄養剤又は医薬剤を人体内へ投与するデバイスを意味し、更には栄養剤等を人体内へ経皮投与する治具を意味するものである。すなわち、本発明の機能剤投与デバイスは、多糖類からなる基板、基板上に複数個設けられた多糖類からなる台座、及びその各々の台座に１個ずつ設けられた微細糖質針から構成されるものである。尚、図１は従来の引き伸ばし方式により基板上に設けた微細糖質針の概略図であるが、ノズルを用いた従来の引き伸ばし方式による微細糖質針１は基板２上に直接立設されていることがわかる。この基板２の材質には、前記の特許文献１の記載のように、粘着性であり、耐熱性及び伸縮性を有した、紙、テープ、プラスティック性又は金属性シート等が使用されてきたため、微細糖質針の基板への接着強度は十分ではなく、それ故に微細糖質針が基板から脱落し易く、また皮膚挿入時に折れ易いものであった。さらに、前記の引き伸ばし方式における押し出しノズルを高精度に加工したとしても、それらノズルを高精度に集積化して押し出しノズル機構を製作することは極めて困難であり、図１に示す通り、ある程度の間隔をあけて微細糖質針を基板上に立設することとなる。この場合、微細糖質針自体の高集積化は望むべくもないこととなる。従って、ノズルを用いた従来の引き伸ばし方式による微細糖質針では、栄養剤等の投与量の向上は期待できない。  In the present invention, the fine saccharide needle means a fine needle composed of a saccharide, the functional agent means a nutrient or a pharmaceutical agent, and the functional agent administration device means an intradermal skin of the fine saccharide needle. It means a device that administers a nutrient or a pharmaceutical agent into the human body by dissolution in the skin after insertion or residue, and further means a jig for transdermally administering the nutrient or the like into the human body. That is, the functional agent administration device of the present invention is composed of a polysaccharide substrate, a plurality of polysaccharide pedestals provided on the substrate, and a fine saccharide needle provided on each pedestal. Is. FIG. 1 is a schematic view of a fine sugar needle provided on a substrate by a conventional stretching method, but the fine sugar needle 1 by a conventional stretching method using a nozzle is directly erected on a substrate 2. I understand that. As the material of the substrate 2, as described in the above-mentioned Patent Document 1, paper, tape, plasticity, or a metallic sheet that is adhesive and has heat resistance and stretchability has been used. The adhesion strength of the fine saccharide needle to the substrate was not sufficient, and therefore the fine saccharide needle was easily removed from the substrate, and was easily broken when inserted into the skin. Furthermore, even if the extrusion nozzles in the stretching method are processed with high accuracy, it is extremely difficult to integrate the nozzles with high accuracy to produce an extrusion nozzle mechanism. As shown in FIG. The fine sugar needle is opened and is erected on the substrate. In this case, high integration of the fine sugar needle itself is not desired. Therefore, it is not possible to expect an improvement in the dosage of a nutrient or the like with a fine sugar needle by a conventional stretching method using a nozzle.

本発明において多糖類からなる基板とは、特にその大きさ、基板を真上から見た形状は限定されず、基板状のものであれば任意の大きさ、形状で良い。尚、その多糖類には、プルラン、カルボキシメチルセルロース、アミロース、ヒアルロン酸、コンドロイチン硫酸、グリコサミノグリカンなどが使用され得るが、特には、プルラン、カルボキシメチルセルロースが高い溶接性であり、安全性及び安定性が高く、入手容易な製品であるという理由から好適である。次に、本発明において多糖類からなる台座には、その多糖類としてプルラン、カルボキシメチルセルロース、アミロース、ヒアルロン酸、コンドロイチン硫酸、グリコサミノグリカンなどが使用され得るが、特には、プルラン、カルボキシメチルセルロースが高い溶接性であり、安全性及び安定性が高く、入手容易な製品であるという理由から好適である。また、基板と台座の材質（多糖類）には同じ多糖類又は異なる多糖類を用いても良いが、低コスト化のために基板と台座を一体化製造する場合は同じ多糖類を用いることが好適となる。次に、本発明において多糖類からなる台座には、台座高さ１０μｍ〜２ｍｍ、台座上面の直径３０μｍ〜１ｍｍ、前記の基板と接する台座底面の直径４０μｍ〜１．５ｍｍである略円柱形状のものが好適に使用される。この台座高さが１０μｍより小さい場合には、台座成形用の微細金型の加工に過剰なコスト高を招くという理由から好ましくなく、台座高さが２ｍｍより大きい場合には、台座及び微細糖質針が大きくなり過ぎて微細性を失うという理由から好ましくない。また、この台座上面の直径が３０μｍより小さい場合には、台座成形用の微細金型の加工に過剰なコスト高を招くという理由から好ましくなく、台座上面の直径が１ｍｍより大きい場合には、台座上に設ける微細糖質針の先端を鋭利にする引き伸ばし加工が困難になるという理由から好ましくない。さらに、前記の台座底面の直径が４０μｍより小さい場合には、台座成形用の微細金型の加工に過剰なコスト高を招くという理由から好ましくなく、前記底面の直径が１．５ｍｍより大きい場合には、台座上面の直径を３０μｍ〜１ｍｍの範囲内に金型成形加工することが困難になるという理由から好ましくない。尚、台座の形状は特に限定されないが、加工が容易で、かつ加工精度も高いという観点からは、略円柱形状や後述の略多角柱形状が好適である。ちなみに、本発明における前記の略円柱形状、略多角柱形状には、円柱又は多角柱において底面積よりも上面積が大きい場合又は小さい場合、更には同じ場合が含まれ、それ故に略円柱、略多角柱としていることに留意する必要がある。  In the present invention, the substrate made of a polysaccharide is not particularly limited in size and shape when the substrate is viewed from directly above, and may be any size and shape as long as it is a substrate. As the polysaccharide, pullulan, carboxymethylcellulose, amylose, hyaluronic acid, chondroitin sulfate, glycosaminoglycan and the like can be used. In particular, pullulan and carboxymethylcellulose have high weldability and are safe and stable. It is suitable because it is highly productive and easily available. Next, pullulan, carboxymethylcellulose, amylose, hyaluronic acid, chondroitin sulfate, glycosaminoglycan and the like can be used as the polysaccharide for the pedestal comprising the polysaccharide in the present invention, and in particular, pullulan and carboxymethylcellulose are used. It is suitable for the reason that it has high weldability, high safety and stability, and is an easily available product. In addition, the same polysaccharide or different polysaccharides may be used for the material of the substrate and the pedestal (polysaccharide), but the same polysaccharide may be used when the substrate and the pedestal are manufactured integrally for cost reduction. Preferred. Next, in the present invention, the pedestal made of polysaccharide has a substantially cylindrical shape having a pedestal height of 10 μm to 2 mm, a pedestal top surface diameter of 30 μm to 1 mm, and a pedestal bottom surface diameter of 40 μm to 1.5 mm in contact with the substrate. Are preferably used. If this pedestal height is smaller than 10 μm, it is not preferable because it causes excessive cost to process the fine mold for forming the pedestal. If the pedestal height is larger than 2 mm, the pedestal and the fine carbohydrate are not preferred. This is not preferable because the needle becomes too large and loses fineness. Further, when the diameter of the upper surface of the pedestal is smaller than 30 μm, it is not preferable because it causes excessive cost for processing a fine mold for forming the pedestal, and when the diameter of the upper surface of the pedestal is larger than 1 mm, it is not preferable. This is not preferable because the drawing process for sharpening the tip of the fine sugar needle provided on the needle becomes difficult. Furthermore, when the diameter of the pedestal bottom surface is smaller than 40 μm, it is not preferable because it causes excessive cost to process a fine mold for pedestal molding, and when the diameter of the bottom surface is larger than 1.5 mm. Is not preferable because it is difficult to mold the pedestal upper surface within the range of 30 μm to 1 mm. The shape of the pedestal is not particularly limited, but from the viewpoint of easy processing and high processing accuracy, a substantially cylindrical shape or a substantially polygonal column shape described later is preferable. Incidentally, the substantially cylindrical shape and the substantially polygonal column shape in the present invention include a case where the upper area is larger or smaller than the bottom area in the cylinder or the polygonal column, and the same case is included. It should be noted that it is a polygonal prism.

本発明において糖質からなる微細糖質針には、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、前記の台座上面と接する針底面の直径３０μｍ〜１ｍｍである略円錐形状、釣鐘形状等のものが好適に使用される。この針先端の直径が０．５μｍより小さい場合には、超微細な引き伸ばし加工に過剰なコスト高を招くという理由から好ましくなく、針先端の直径が２０μｍより大きい場合には、針先を皮膚に挿入することが困難であり、かつ針挿入時に痛みを伴うという理由から好ましくない。また、この針長さが５０μｍより小さい場合には、針先端の微細な引き伸ばし加工が高コストになるという理由から好ましくなく、針長さが２ｍｍより大きい場合には、引き伸ばし加工により針径が太くなって針の皮膚挿入時の痛みが大きくなるという理由から好ましくない。さらに、前記の針底面の直径が３０μｍより小さい場合には、針を皮膚に挿入する際に脆くなるという理由から好ましくなく、前記底面の直径が１ｍｍより大きい場合には、台座上に設ける微細糖質針の先端を鋭利に引き伸ばし加工することが困難になるという理由から好ましくない。尚、微細糖質針の形状は特に限定されないが、本製造法による加工のし易さ及び台座上面が略円形状であるという観点からは、略円錐形状、釣鐘形状、宝珠形状が好適である。このうち、釣鐘形状、宝珠形状は、略円錐形状の場合と比べて、微細糖質針自体の体積が大きく、栄養剤等の投与量を増加させるには好適である。この宝珠形状には、前述の微細糖質針の大きさにおける数値範囲に加えて、針長さ方向における略中間部の最大直径が５０μｍ〜１．５ｍｍが好適であるが、この最大直径が５０μｍより小さい場合には、微細曲線に引き伸ばし加工する上で精度に限界があるという理由から好ましくなく、最大直径が１．５ｍｍより大きい場合には、針の皮膚挿入時に痛みを伴うという理由から好ましくない。次に、本発明における微細糖質針の糖質には、人体内で容易に溶解し、生体に適合しやすい栄養剤であるという理由から、主成分としてマルトース、他成分としてグルコース、トレハロース等の糖類が好適に使用される。尚、図２は本発明の機能剤投与デバイスにおける基板上台座（略円柱形状）の概略図であるが、この図では多糖類からなる基板６上に、略円柱形状の多糖類からなる台座３が９個設けられており、各台座においては台座上面４、台座底面５の位置関係が図示されている。これらの台座は、台座上面が台座底面より小さい面積を有する略円柱形状となっている。また、図３は本発明の略円錐形状の微細糖質針を有する機能剤投与デバイスの概略図であるが、この図では図２で示された多糖類からなる台座３の各上面に略円錐形状の微細糖質針７が１個ずつ設けられており、前記の微細糖質針７が９個示されている。次に図４は、図３の機能剤投与デバイスについて、台座及び基板を一体化製造した機能剤投与デバイスの断面を示す概略図である。この図４では、一体化製造された台座及び基板８が示されているが、この場合には基板と台座は同じ多糖類の材質からなり、従って基板と台座の境界はなく、それらは一体化して図示されている。さらに図５は、図３の機能剤投与デバイスについて、台座及び基板を分離製造した機能剤投与デバイスの断面を示す概略図である。この図５では、分離製造された基板１０及び分離製造された台座９が示されているが、この場合には基板１０と台座９は異なる多糖類の材質からなり、従って基板１０と台座９には境界があり、それらは分離して図示され、それ故に台座底面５は明瞭に示される。次に、図６は本発明の釣鐘形状の微細糖質針を有する機能剤投与デバイスの概略図であるが、この図では図２で示された多糖類からなる台座３の各上面に釣鐘形状の微細糖質針１１が１個ずつ設けられており、前記の微細糖質針１１が９個示されている。また、図７は本発明の宝珠形状の微細糖質針を有する機能剤投与デバイスの概略図であるが、この図では図２で示された多糖類からなる台座３の各上面に宝珠形状の微細糖質針１２が１個ずつ設けられており、前記の微細糖質針１２が９個示されている。  In the present invention, the fine sugar needle made of sugar has a substantially conical shape with a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, and a needle bottom surface diameter of 30 μm to 1 mm in contact with the pedestal top surface, A bell shape or the like is preferably used. When the diameter of the needle tip is smaller than 0.5 μm, it is not preferable because it leads to excessive cost for ultra-fine stretching. When the diameter of the needle tip is larger than 20 μm, the needle tip is placed on the skin. It is not preferable because it is difficult to insert the needle and is painful when the needle is inserted. Further, when the needle length is smaller than 50 μm, it is not preferable because fine stretching of the needle tip is expensive, and when the needle length is larger than 2 mm, the needle diameter is increased by the stretching process. This is not preferable because the pain when the needle is inserted into the skin increases. Further, when the diameter of the bottom surface of the needle is smaller than 30 μm, it is not preferable because it becomes brittle when the needle is inserted into the skin. When the diameter of the bottom surface is larger than 1 mm, the fine sugar provided on the pedestal is not preferable. This is not preferable because it is difficult to sharply extend the tip of the quality needle. The shape of the fine saccharide needle is not particularly limited, but from the viewpoint of ease of processing by this production method and the pedestal upper surface having a substantially circular shape, a substantially conical shape, a bell shape, and a jewel shape are preferred. . Among these, the bell shape and the jewel shape have a larger volume of the fine sugar needle itself than the substantially conical shape, and are suitable for increasing the dosage of nutrients and the like. In addition to the numerical range of the size of the fine sugar needle described above, the maximum diameter of the substantially intermediate portion in the needle length direction is preferably 50 μm to 1.5 mm, but this maximum diameter is 50 μm. If the diameter is smaller, it is not preferable because the accuracy is limited in stretching to a fine curve, and if the maximum diameter is larger than 1.5 mm, it is not preferable because it causes pain when the needle is inserted into the skin. . Next, the carbohydrate of the fine sugar needle in the present invention is a nutrient that easily dissolves in the human body and is easily adapted to the living body, so that maltose as the main component, glucose, trehalose as the other component, etc. Saccharides are preferably used. FIG. 2 is a schematic view of the base on the substrate (substantially cylindrical shape) in the functional agent administration device of the present invention. In this figure, the base 3 made of a substantially columnar polysaccharide on the substrate 6 made of the polysaccharide. 9 are provided, and in each pedestal, the positional relationship between the pedestal top surface 4 and the pedestal bottom surface 5 is shown. These pedestals have a substantially cylindrical shape in which the upper surface of the pedestal has an area smaller than the bottom surface of the pedestal. FIG. 3 is a schematic view of a functional agent administration device having a substantially corn-shaped fine saccharide needle of the present invention. In this figure, a substantially cone is formed on each upper surface of the base 3 made of the polysaccharide shown in FIG. One fine sugar needle 7 having a shape is provided, and nine fine sugar needles 7 are shown. Next, FIG. 4 is a schematic view showing a cross section of the functional agent administration device in which the pedestal and the substrate are integrally manufactured with respect to the functional agent administration device of FIG. In FIG. 4, the pedestal and the substrate 8 manufactured in an integrated manner are shown. In this case, the substrate and the pedestal are made of the same polysaccharide material, so there is no boundary between the substrate and the pedestal, and they are integrated. Is shown. FIG. 5 is a schematic view showing a cross section of the functional agent administration device in which the pedestal and the substrate are separately manufactured with respect to the functional agent administration device of FIG. In FIG. 5, the separated substrate 10 and the separately produced pedestal 9 are shown. In this case, the substrate 10 and the pedestal 9 are made of different polysaccharide materials, and thus the substrate 10 and the pedestal 9 are attached to each other. Are bounded and they are shown separately, so the pedestal bottom 5 is clearly shown. Next, FIG. 6 is a schematic view of a functional agent administration device having a bell-shaped fine sugar needle of the present invention. In this figure, a bell shape is formed on each upper surface of the pedestal 3 made of the polysaccharide shown in FIG. The fine sugar needles 11 are provided one by one, and nine fine sugar needles 11 are shown. FIG. 7 is a schematic view of a functional agent administration device having a jewel-shaped fine saccharide needle of the present invention. In this figure, a jewel-shaped device is formed on each upper surface of the base 3 made of the polysaccharide shown in FIG. One fine sugar needle 12 is provided, and nine fine sugar needles 12 are shown.

本発明において多糖類からなる台座には、上記の略円柱形状の台座とは異なる別態様として、台座高さ１０μｍ〜２ｍｍ、台座上面が直径３０μｍ〜１ｍｍの円に内接又は外接し、前記の基板と接する台座底面が直径４０μｍ〜１．５ｍｍの円に内接又は外接する略多角柱形状のものが好適に使用される。この台座高さが１０μｍより小さい場合には、台座成形用の微細金型の加工に過剰なコスト高を招くという理由から好ましくなく、台座高さが２ｍｍより大きい場合には、台座及び微細糖質針が大きくなり過ぎて微細性を失うという理由から好ましくない。また、台座上面が内接又は外接する円の直径が３０μｍより小さい場合には、台座成形用の微細金型の加工に過剰なコスト高を招くという理由から好ましくなく、前記円の直径が１ｍｍより大きい場合には、台座上に設ける微細糖質針の先端を鋭利にする引き伸ばし加工が困難になるという理由から好ましくない。さらに、前記の台座底面が内接又は外接する円の直径が４０μｍより小さい場合には、台座成形用の微細金型の加工に過剰なコスト高を招くという理由から好ましくなく、前記円の直径が１．５ｍｍより大きい場合には、台座上面の直径を３０μｍ〜１ｍｍの範囲内に金型成形加工することが困難になるという理由から好ましくない。尚、台座の形状は特に限定されないが、加工が容易で、かつ加工精度も高いという観点からは、前述の略円柱形状や略多角柱形状が好適である。次に、本発明において糖質からなる微細糖質針には、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、針底面が該台座上面と同一形状である略多角錐形状又は略釣鐘形状等のものが好適に使用される。これらの好適な数値範囲の理由については前述と同様である。尚、微細糖質針の形状は特に限定されないが、本製造法による加工のし易さ及び台座上面が略多角形状であるという観点からは、略多角錐形状、略釣鐘形状、略宝珠形状が好適である。このうち、略釣鐘形状、略宝珠形状は、略多角錐形状の場合と比べて、微細糖質針自体の体積が大きく、栄養剤等の投与量を増加させるには好適である。この略宝珠形状には、前述の微細糖質針の大きさ及び形状に加えて、針長さ方向における略中間部が直径５０μｍ〜１．５ｍｍの円に内接又は外接する略多角形であることが好適であるが、前記直径が５０μｍより小さい場合には、微細曲線に引き伸ばし加工する上で精度に限界があるという理由から好ましくなく、前記直径が１．５ｍｍより大きい場合には、針の皮膚挿入時に痛みを伴うという理由から好ましくない。尚、針長さ方向における略中間部が直径５０μｍ〜１．５ｍｍの円に内接又は外接する略多角形であることとは、前記の略中間部の位置において水平面で微細糖質針を切断した時の断面が略多角形であり、かつこの略多角形が直径５０μｍ〜１．５ｍｍの円に内接又は外接するということを意味するものである。また、この微細糖質針においては、前述の釣鐘形状、宝珠形状の微細糖質針を水平面で切断した時の断面が略円形（台座上面が略円形のため）であるのに対し、前記の略釣鐘形状、略宝珠形状を同様に切断した時の断面が略多角形（台座上面が略多角形状のため）であるという点で異なり、それ故に本発明では略釣鐘形状、略宝珠形状と記すことに留意を要する。尚、図８は本発明の略四角錐形状の微細糖質針を有する機能剤投与デバイスの概略図であるが、この図では略四角柱形状の多糖類からなる台座３の各上面に略四角錐形状の微細糖質針１３が１個ずつ設けられており、前記の微細糖質針１３が９個示されている。次に、図９は本発明の略釣鐘形状の微細糖質針を有する機能剤投与デバイスの概略図であるが、この図では略四角柱形状の多糖類からなる台座３の各上面に略釣鐘形状の微細糖質針１４が１個ずつ設けられており、前記の微細糖質針１４が９個示されている。また、図１０は本発明の略宝珠形状の微細糖質針を有する機能剤投与デバイスの概略図であるが、この図では略四角柱形状の多糖類からなる台座３の各上面に略宝珠形状の微細糖質針１５が１個ずつ設けられており、前記の微細糖質針１５が９個示されている。  In the present invention, the pedestal made of polysaccharide is inscribed or circumscribed in a circle having a pedestal height of 10 μm to 2 mm and a top surface of the pedestal of 30 μm to 1 mm as a different aspect from the above substantially cylindrical pedestal, A base having a substantially polygonal column shape in which the pedestal bottom contacting the substrate is inscribed or circumscribed in a circle having a diameter of 40 μm to 1.5 mm is preferably used. If this pedestal height is smaller than 10 μm, it is not preferable because it causes excessive cost to process the fine mold for forming the pedestal. If the pedestal height is larger than 2 mm, the pedestal and the fine carbohydrate are not preferred. This is not preferable because the needle becomes too large and loses fineness. Further, when the diameter of the circle inscribed or circumscribed by the upper surface of the pedestal is smaller than 30 μm, it is not preferable because of excessive cost for processing the fine mold for forming the pedestal, and the diameter of the circle is less than 1 mm. In the case where it is large, it is not preferable because the drawing process for sharpening the tip of the fine sugar needle provided on the pedestal becomes difficult. Furthermore, when the diameter of the circle inscribed or circumscribed by the base of the pedestal is smaller than 40 μm, it is not preferable because it causes excessive cost to process a fine mold for forming the pedestal, and the diameter of the circle is not preferable. When the diameter is larger than 1.5 mm, it is not preferable because it is difficult to mold the pedestal upper surface within the range of 30 μm to 1 mm. The shape of the pedestal is not particularly limited, but from the viewpoint of easy processing and high processing accuracy, the above-described substantially cylindrical shape or substantially polygonal column shape is preferable. Next, in the present invention, the fine saccharide needle made of saccharide has a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, and a substantially polygonal pyramid shape in which the needle bottom is the same shape as the top surface of the pedestal. A substantially bell shape or the like is preferably used. The reason for these preferable numerical ranges is the same as described above. The shape of the fine saccharide needle is not particularly limited, but from the viewpoint of ease of processing by this production method and the pedestal upper surface being a substantially polygonal shape, a substantially polygonal pyramid shape, a substantially bell shape, and a substantially jewel shape are Is preferred. Among these, the substantially bell shape and the substantially jewel shape have a larger volume of the fine sugar needle itself than the substantially polygonal pyramid shape, and are suitable for increasing the dosage of nutrients and the like. In addition to the size and shape of the fine sugar needle described above, the substantially jewel shape is a substantially polygonal shape in which a substantially middle portion in the needle length direction is inscribed or circumscribed to a circle having a diameter of 50 μm to 1.5 mm. However, when the diameter is smaller than 50 μm, it is not preferable because the accuracy is limited in drawing to a fine curve, and when the diameter is larger than 1.5 mm, it is not preferable. It is not preferable because it is painful when the skin is inserted. In addition, the fact that the substantially middle part in the needle length direction is a substantially polygon that is inscribed or circumscribed to a circle having a diameter of 50 μm to 1.5 mm means that the fine sugar needle is cut in a horizontal plane at the position of the substantially middle part. This means that the cross section is substantially polygonal and that this polygon is inscribed or circumscribed to a circle having a diameter of 50 μm to 1.5 mm. Further, in this fine sugar needle, the cross-section when the above-mentioned bell-shaped and jewel-shaped fine sugar needles are cut in a horizontal plane is substantially circular (because the upper surface of the base is substantially circular), The cross section when the substantially bell shape and the approximately jewel shape are similarly cut is substantially polygonal (because the upper surface of the pedestal is approximately polygonal), and therefore in the present invention, it is described as the approximately bell shape and approximately jewel shape. Note that. FIG. 8 is a schematic view of a functional agent administration device having a fine saccharide needle having a substantially quadrangular pyramid shape according to the present invention. In FIG. One pyramid-shaped fine sugar needle 13 is provided, and nine of the fine sugar needles 13 are shown. Next, FIG. 9 is a schematic view of a functional agent administration device having a substantially bell-shaped fine sugar needle of the present invention. In this figure, a substantially bell is formed on each upper surface of the pedestal 3 made of a polysaccharide having a substantially quadrangular prism shape. One fine sugar needle 14 having a shape is provided, and nine of the fine sugar needles 14 are shown. FIG. 10 is a schematic diagram of a functional agent administration device having a substantially jewel-shaped fine sugar needle of the present invention. In this figure, a substantially jewel-shaped shape is formed on each upper surface of a base 3 made of a substantially quadrangular prism-shaped polysaccharide. The fine sugar needles 15 are provided one by one, and nine fine sugar needles 15 are shown.

本発明において微細糖質針の糖質に含有させる栄養剤には、ビタミンＡ、ビタミンＢ複合体、ビタミンＣ、ビタミンＤ、ビタミンＥ、ビタミンＫ、グルタミン、必須アミノ酸、非必須アミノ酸、γ−アミノ酪酸、タウリン、脂肪酸、核酸、アドレナリン、から選択される１又は２以上の栄養剤であることが好適である。特に、レチノール、レチナールなどのビタミンＡ、チアミン、リボフラビン、ナイアシン、アデニン、パントテン酸、ピリドキシン、ピリドキサミン、ビオチン、アデニル酸、葉酸、葉酸と他のビタミンＢ化合物との混合物、ビタミンＳ、シアノコバラミン、ピリミジン−５−カルボン酸、ビタミンＢ−１４及びＢ−１０及びＢ−１１の混合物、ジメチルグリシン、アミグダリン、ビタミンＢ−２２、葉酸、ビタミンＢ−９、イノシトール、Ｌ−カルニチン、ビオチン、パラアミノ安息香酸などのビタミンＢ複合体、Ｌ−アスコルビン酸などのビタミンＣ、エルゴカルシフェロールなどのビタミンＤ、トコフェロールなどのビタミンＥ、フィロキノンなどのビタミンＫ、トリプトファン、リシン、メチオニン、フェニルアラニン、トレオニン、イソロイシン、ロイシン、ヒスチジンなどの必須アミノ酸、アラニン、アルギニン、アスパラギン酸、セリン、システイン、グルタミン、グリシン、プロリン、チロシンなどの非必須アミノ酸、アミノエチルスルホン酸などのタウリン、ブタン酸、ヘキサドコサン酸などの脂肪酸、ＤＮＡ、ＲＮＡなどの核酸、カテコールアミンなどのアドレナリン、などが好適に使用され得る。尚、微細糖質針の糖質に栄養剤を含有させる方法としては特に限定されないが、微細糖質針の糖質原料に前記栄養剤を混合した後にその加熱溶融混合物を微細糖質針化する方法や、加熱溶融した糖質原料に前記栄養剤を混合させた後にその加熱溶融混合物を微細糖質針化する方法等があるが、前記栄養剤の機能を損ねない方法であれば何れの方法でも良い。  In the present invention, the nutrients contained in the sugar of the fine sugar needle include vitamin A, vitamin B complex, vitamin C, vitamin D, vitamin E, vitamin K, glutamine, essential amino acid, non-essential amino acid, γ-amino. One or more nutrients selected from butyric acid, taurine, fatty acids, nucleic acids, and adrenaline are preferred. In particular, vitamin A such as retinol and retinal, thiamine, riboflavin, niacin, adenine, pantothenic acid, pyridoxine, pyridoxamine, biotin, adenylic acid, folic acid, folic acid and a mixture of other vitamin B compounds, vitamin S, cyanocobalamin, pyrimidine- 5-carboxylic acid, vitamin B-14 and a mixture of B-10 and B-11, dimethylglycine, amygdalin, vitamin B-22, folic acid, vitamin B-9, inositol, L-carnitine, biotin, paraaminobenzoic acid, etc. Vitamin B complex, vitamin C such as L-ascorbic acid, vitamin D such as ergocalciferol, vitamin E such as tocopherol, vitamin K such as phylloquinone, tryptophan, lysine, methionine, phenylalanine, threonine Essential amino acids such as isoleucine, leucine and histidine, non-essential amino acids such as alanine, arginine, aspartic acid, serine, cysteine, glutamine, glycine, proline and tyrosine, fatty acids such as taurine such as aminoethyl sulfonic acid, butanoic acid and hexadocosanoic acid , Nucleic acids such as DNA and RNA, adrenaline such as catecholamine, and the like can be suitably used. In addition, there is no particular limitation on the method of adding a nutrient to the sugar of the fine sugar needle, but after mixing the nutrient with the sugar raw material of the fine sugar needle, the heated and melted mixture is made into a fine sugar needle. There is a method, a method of mixing the nutrient with the heated and melted carbohydrate raw material, and then making the heated melt mixture into a fine sugar needle, etc., but any method as long as it does not impair the function of the nutrient But it ’s okay.

本発明において微細糖質針の糖質に含有させる医薬剤には、鎮痛薬剤、消炎薬剤、解熱鎮痛消炎薬剤、抗真菌剤、抗菌剤、抗ウィルス薬、強心薬、血栓溶解剤、止血剤、利尿薬、高血圧治療薬、麻酔剤、鎮静剤、睡眠薬、抗痙攣薬、抗不安薬、酔い止め薬、精神安定剤、抗うつ剤、睡眠鎮静剤、抗原虫薬剤、から選択される１の医薬剤であることが好適である。特に、アセトアミノフェン、サリチル酸塩、モルヒネなどの鎮痛薬剤、アスピリン、サリチル酸、ジクロフェナク、インドメタシン、イブプロフェン、ケトプロフェン、ナプロキセン、ピロキシカムなどの消炎薬剤、アセトアミノフェンなどの解熱鎮痛消炎薬剤、アンフォテリシンＢ、フルシトシン、エコナゾール、ミコナゾール、フルコナゾール、イトラコナゾール、ミカファンギン、塩酸テルビナフィン、リラナフタート、ブテナフィン、アモロルフィン、グリセオフルビンなどの抗真菌剤、スルファメチゾール、ベンジルペニシリン、クロロテトラサイクリン、クロラムフェニコールなどの抗菌剤、アシクロビール、ガンシクロビル、フォスカルネットなどの抗ウィルス薬、ジギタリスなどの強心薬、ヘパリン、ワルファリン、ウロキナーゼなどの血栓溶解剤、トラネキサム酸、コラーゲンなどの止血剤、濃グリセリン、ヒドロクロロサイアザイド、トリクロルメチアジド、インダパミド、クロルタリドン、スピロノラクトンカンレノ酸カリウム、エプレレノン、アセタゾラミド、塩酸ドパミン、アミノフィリン、カルペリチド、塩酸クロルプロマジンなどの利尿薬、トリクロルメチアジド、ヒドロクロロチアジド、フロセミド、ブメタニド、エタクリン酸、スピロノラクトン、トリアムテレン、アムロジピン、ジルチアゼムなどの高血圧治療薬、クエン酸フェンタニル、ベンゾジアゼピン、ジアゼバム、塩酸プロメタジン、リドカインなどの麻酔剤、チオペタールなどの鎮静剤、トリアゾラム、エキゾラム、ベントバルビタール、フルニトラゼバム、フルラゼバムなどの睡眠薬、フェノバルビタールなどの抗痙攣薬、エキゾラム、ロラゼバム、クロキサゾラム、プラゼバムなどの抗不安薬、塩酸ジフェンヒドラミン、塩酸プロメタジン、ロラタジンなどの酔い止め薬、メジートランキライザなどの精神安定剤、塩酸ププロピオン、塩酸トラゾドン、スルピリドなどの抗うつ剤、トリアゾラム、エスタゾラム、アモバルビタール、酒石酸ゾルビデムなどの睡眠鎮静剤、スルファドキシン−ピリメタミンなどの抗原虫薬剤、などが好適に使用され得る。尚、微細糖質針の糖質に医薬剤を含有させる方法としては特に限定されないが、微細糖質針の糖質原料に前記医薬剤を混合した後にその加熱溶融混合物を微細糖質針化する方法や、加熱溶融した糖質原料に前記医薬剤を混合させた後にその加熱溶融混合物を微細糖質針化する方法等があるが、前記医薬剤の機能を損ねない方法であれば何れの方法でも良い。  In the present invention, the pharmaceutical agent contained in the carbohydrate of the fine saccharide needle includes an analgesic agent, an anti-inflammatory agent, an antipyretic analgesic / anti-inflammatory agent, an antifungal agent, an antibacterial agent, an antiviral agent, a cardiotonic agent, a thrombolytic agent, a hemostatic agent, 1 doctor selected from diuretics, antihypertensives, anesthetics, sedatives, sleeping pills, anticonvulsants, anxiolytics, anti-anxiety drugs, tranquilizers, antidepressants, sleep sedatives, antiprotozoal drugs Preferably it is a drug. In particular, analgesics such as acetaminophen, salicylate, morphine, aspirin, salicylic acid, diclofenac, indomethacin, ibuprofen, ketoprofen, naproxen, piroxicam, antipyretic analgesics such as acetaminophen, amphotericin B, flucytosine, Antifungal agents such as econazole, miconazole, fluconazole, itraconazole, micafungin, terbinafine hydrochloride, rylanaphthalate, butenafine, amorolfine, griseofulvin, antibacterial agents such as sulfamethizole, benzylpenicillin, chlorotetracycline, chloramphenicol, acyclobeer, Antiviral drugs such as ganciclovir and Foscarnet, cardiotonic drugs such as digitalis, heparin, warfarin, uroki Thrombolytic agents such as sesame, hemostatic agents such as tranexamic acid and collagen, concentrated glycerin, hydrochlorothiazide, trichlormethiazide, indapamide, chlorthalidone, spironolactone canrenoic acid potassium, eplerenone, acetazolamide, dopamine hydrochloride, aminophylline, carperitide, hydrochloric acid Diuretics such as chlorpromazine, anti-hypertensives such as trichlormethiazide, hydrochlorothiazide, furosemide, bumetanide, ethacrynic acid, spironolactone, triamterene, amlodipine, diltiazem, anesthetics such as fentanyl citrate, benzodiazepine, diazebam, promethazine hydrochloride, lidocaine, thiopetal Sleepers such as sedatives such as triazolam, exolam, bentobarbital, flunitrazebum, flurazebam Drugs, anticonvulsants such as phenobarbital, anti-anxiety drugs such as exolam, lorazebum, cloxazolam, and prazebam, anti-anxiety drugs such as diphenhydramine hydrochloride, promethazine hydrochloride, loratadine, tranquilizers such as meji tranquilizer, proppropion hydrochloride, Antidepressants such as trazodone hydrochloride and sulpiride, sleep sedatives such as triazolam, estazolam, amobarbital, zolvidem tartrate, antiprotozoal drugs such as sulfadoxine-pyrimethamine, and the like can be suitably used. The method for containing the pharmaceutical agent in the saccharide of the fine saccharide needle is not particularly limited, but after mixing the pharmaceutical agent with the saccharide raw material of the fine saccharide needle, the heated melt mixture is made into a fine saccharide needle. There is a method, a method of mixing the pharmaceutical agent with a heated and melted saccharide raw material, and then making the heated molten mixture into a fine saccharide needle, and any method as long as it does not impair the function of the pharmaceutical agent But it ’s okay.

本発明の機能剤投与デバイスの製造方法においては、前記の多糖類からなる基板上に、金型成型による前記の多糖類からなる台座を複数個成形した後、昇降制御機構を有し水平面に沿うステージに、前記基板を前記台座が鉛直下向き方向を指すように取り付け、前記台座上面を静置状態の９０℃〜１２０℃に温度制御された糖質加熱容器内の溶融した前記糖質の上面に接触させた後、前記ステージを昇降させることにより前記台座上面に前記微細糖質針を成形することが好適になされる。この前記の昇降制御機構は、微細な鉛直方向の制御性が必要であるという理由から、微細なデジタル駆動が可能なステップモータによる制御機構などが好適に使用され得る。また、この前記の糖質加熱容器は、安定に糖質溶融温度を保持するという理由から、恒温特性を有するステンレス製加熱容器などが好適に使用され得る。さらには、この前記の糖質加熱容器の制御温度が９０℃より小さい場合、十分に糖質が溶融されずに凝固部が残るという理由から好ましくなく、前記制御温度が１２０℃より大きい場合、糖質が変性するという理由から好ましくない。尚、本発明において好適に使用され得る糖質の主成分であるマルトース、他成分であるグルコース又はトレハロースのうち、主成分のマルトースと他成分のグルコースは前記の温度制御範囲内にて溶融状態とすることができるが、他成分のトレハロースは溶融せず、従ってマルトース及びトレハロースの糖質混合物は前記の温度制御範囲内にて溶融マルトース内に結晶トレハロースが混合したものとなる。また、本発明において微細糖質針の糖質に好適に含有され得る前記の栄養剤や医薬剤は、いずれも前記の温度制御範囲内で変質することなく、かつそれらの機能も保持され得るものである。  In the method for producing a functional agent administration device of the present invention, a plurality of pedestals made of the above-mentioned polysaccharides by molding are formed on the substrate made of the above-mentioned polysaccharides, and then have an elevation control mechanism and follow a horizontal plane. On the stage, the substrate is attached so that the pedestal points in the vertically downward direction, and the upper surface of the pedestal is placed on the upper surface of the molten saccharide in the saccharide heating container whose temperature is controlled to 90 ° C. to 120 ° C. After the contact, the fine sugar needle is preferably formed on the upper surface of the pedestal by raising and lowering the stage. As the above-described lift control mechanism, a control mechanism using a step motor capable of fine digital driving can be suitably used because fine vertical controllability is necessary. As the sugar heating container, a stainless steel heating container having a constant temperature characteristic can be suitably used because it stably maintains the sugar melting temperature. Furthermore, when the control temperature of the sugar heating container is lower than 90 ° C., it is not preferable because the saccharide is not sufficiently melted and a solidified part remains, and when the control temperature is higher than 120 ° C., It is not preferable because the quality is denatured. In addition, maltose which is a main component of a carbohydrate that can be preferably used in the present invention, among glucose or trehalose as another component, maltose as a main component and glucose as another component are in a molten state within the above temperature control range. However, the other component trehalose does not melt, so that the sugar mixture of maltose and trehalose is a mixture of crystalline trehalose in the molten maltose within the above temperature control range. Further, in the present invention, any of the above-mentioned nutrients and pharmaceutical agents that can be suitably contained in the sugar of the fine sugar needle can be maintained within the above temperature control range and can retain their functions. It is.

本発明の機能剤投与デバイスの製造方法においては、前記ステージの昇降移動距離をデジタル式に微小に区切り、前記の昇降移動距離を任意に変更して前記ステージ昇降の移動速度を微調整する制御方法により、前記台座上面に前記微細糖質針を高精度に成形することが好適になされる。この前記移動速度を微調整する制御方法には、速度の可変が必要であるという理由から、コンピュータより所定信号を得て駆動する数値制御（ＮＣ制御）方法などが好適に使用され得る。尚、本発明の機能剤投与デバイスにおいては、微細糖質針の形状を制御するに際し、前記台座上面を溶融した前記糖質上面に接触させた後、高速に前記ステージを上昇させることにより、微細糖質針はアスペクト比の高い（細く、かつ長い）形状となり、一方、低速に前記ステージを上昇させることにより、微細糖質針はアスペクト比の低い（太く、かつ短い）形状となる。すなわち、前記ステージの上昇速度を高速又は低速に制御することにより、前記台座上面が円形の場合はアスペクト比が高い又は低い円錐形状の微細糖質針となり、前記台座上面が多角形の場合はアスペクト比が高い又は低い多角錐形状の微細糖質針となる。また、前記ステージの上昇速度を初期段階から中期段階まで低速とし、後期段階で高速に制御すると、前記台座上面が円形の場合は釣鐘形状の微細糖質針となり、前記台座上面が多角形の場合は略釣鐘形状の微細糖質針となる。さらには、前記ステージを一旦上昇させて停止し、次に前記ステージを降下させることにより、微細糖質針の幅を大きくすることが可能であり、このようなステージの昇降制御を行うことにより、前記の宝珠、略宝珠形状における湾曲下部を成形することができ、その後は前記ステージを定速に上昇させることにより、前記台座上面が円形の場合は宝珠形状の微細糖質針となり、前記台座上面が多角形の場合は略宝珠形状の微細糖質針となる。要するに、本発明の機能剤投与デバイスの製造方法においては、上述の通り、前記ステージの昇降制御を種々に組合せて所定の昇降制御を行うことにより、微細糖質針の形状を種々に制御することが可能となる。  In the method for producing a functional agent administration device of the present invention, the control method for finely adjusting the moving speed of the stage ascending / descending by arbitrarily dividing the moving distance of the stage in a digital manner and arbitrarily changing the moving distance of the stage Thus, it is preferable to mold the fine sugar needle on the pedestal upper surface with high accuracy. As the control method for finely adjusting the moving speed, a numerical control (NC control) method for obtaining and driving a predetermined signal from a computer can be suitably used because the speed needs to be varied. In the functional agent administration device of the present invention, when controlling the shape of the fine saccharide needle, the upper surface of the pedestal is brought into contact with the molten saccharide upper surface, and then the stage is raised at a high speed to thereby finely adjust the shape of the fine saccharide needle. The sugar needle has a shape with a high aspect ratio (thin and long), while the fine sugar needle has a shape with a low aspect ratio (thick and short) by raising the stage at a low speed. That is, by controlling the ascending speed of the stage at a high speed or a low speed, when the pedestal top surface is circular, the aspect ratio is high or low, resulting in a cone-shaped fine sugar needle, and when the pedestal top surface is polygonal, the aspect ratio It becomes a fine sugar needle of a polygonal pyramid shape with a high or low ratio. In addition, when the ascending speed of the stage is slow from the initial stage to the middle stage and is controlled at a high speed in the late stage, if the pedestal upper surface is circular, it becomes a bell-shaped fine sugar needle, and the pedestal upper surface is polygonal Becomes a fine sugar needle with a substantially bell shape. Furthermore, it is possible to increase the width of the fine sugar needle by temporarily raising and stopping the stage and then lowering the stage, and by performing such an elevation control of the stage, The curved lower part in the above-mentioned jewel, approximately jewel shape can be molded, and then the stage is raised at a constant speed, so that when the pedestal upper surface is circular, it becomes a jewel-shaped fine sugar needle, and the pedestal upper surface When is a polygonal shape, it becomes a fine sugar needle having a substantially jewel shape. In short, in the method for producing a functional agent administration device of the present invention, as described above, the shape of the fine sugar needle can be variously controlled by performing predetermined elevation control by combining the elevation control of the stage variously. Is possible.

本発明の機能剤投与デバイスの製造装置においては、９０℃〜１２０℃の温度制御機構を有する糖質加熱容器、及び前記基板を前記台座が鉛直下向き方向を指すように取付けることが可能な昇降制御機構を有する水平面に沿うステージであり、更に前記台座上面と溶融した前記糖質の上面との距離を任意に位置決めする位置合わせ制御機構を有する前記ステージ、から構成されるものが好適である。また、この前記の糖質加熱容器は、前述の通り、安定に糖質溶融温度を保持するという理由から、恒温特性を有するステンレス製加熱容器などが好適に使用され得る。さらに、この前記の位置合わせ制御機構には、微細な位置の検出が可能であるという理由から、例えば、波長サイズで変動するレーザ光の干渉強度の検出、光を利用するエンコーダ、機械式ではノギス機構などを利用した位置合わせ制御装置が好適に使用され得る。尚、図１１は従来の引き伸ばし方式に基づく微細糖質針製造装置による微細糖質針の作製途中状態を示す概略模式図であるが、この図では溶融糖質材供給機１７に設けられている２個のノズル１８から溶融糖質材１９が、基板加熱ヒータ２０により加熱されている基板２上に押し出された後、溶融糖質材供給機の昇降制御機構１６により溶融糖質材１９が引き伸ばされて前記微細糖質針１が２個作製される途中状態が示されており、基板２上には前記微細糖質針１で作製完了のものが２個、作製途中のものが２個図示されている。かかる従来の引き伸ばし方式に基づく微細糖質針製造装置では、溶融糖質材供給機１７に高精度加工したノズル１８を設けることは難しく、かつその分高コストとなるため、一度に多くの微細糖質針を基板２上に作製することは困難であることが理解でき得る。ちなみに図１１では糖質材を明瞭にする為、ドット表示による陰影をつけて糖質材を図示しているが、これは下記の図１２及び図１３においても同様である。また、図１２は本発明の機能剤投与デバイスの製造装置による微細糖質針の作製途中状態を示す概略模式図であるが、この図では多糖類からなる基板６上に、金型成型による前記の多糖類からなる台座３を３個成形した後、基板取付けステージの昇降制御機構２１を有し水平面に沿う基板取付けステージ２２に、前記基板６を前記台座３が鉛直下向き方向を指すように取り付け、前記台座３の上面を静置状態の９０℃〜１２０℃に温度制御された糖質加熱容器２３内の溶融した前記糖質（溶融糖質材１９）の上面に接触させた後、前記ステージ２２を昇降させることにより前記台座３の上面に前記微細糖質針を３個作製する途中状態、すなわち溶融糖質材の引き伸ばし途中の微細糖質針２４が３個示されている。ちなみに、この図においては、前記ステージ２２は前記台座３と溶融した前記糖質（溶融糖質材１９）の上面との距離を任意に位置決めする位置合わせ制御機構として、レーザ光干渉による位置合わせ制御機構２５を有するが、この前記制御機構２５からは往復レーザ光２６が前記距離を位置決めするべく鉛直下向きに照射されている状態について、その概略が図示されていることに留意を要する。尚、往復レーザ光２６は、前記の台座上面４と前記の溶融糖質材１９の上面との距離を任意に位置決めするためのものであるが、直接に両上面間の距離を往復レーザ光２６で計測することは難しく、その代わりに、図１２の通り、前記ステージ面（基板が取付けられていない面）に往復レーザ光を照射してステージ位置計測を行ない、例えば、前記台座上面が静置状態にある前記溶融糖質の上面と接触した時点におけるステージ位置を基準位置として往復レーザ光２６により計測し、その基準位置からの台座の移動距離をレーザ光干渉による位置合わせ制御機構２５を用いて微調整すれば良い。前記の制御機構２５により、ステージ位置の昇降、すなわち前記の溶融糖質材１９と接触している台座上面４の昇降を制御して、微細糖質針の形状を略円錐、釣鐘、宝珠、略多角錐、略釣鐘、略宝珠の形状に作製することとなる。さらには、図１３は本発明の機能剤投与デバイスの製造装置による微細糖質針の作製完了状態を示す概略模式図であるが、この図では前記ステージ２２を昇降させることにより前記台座３の上面に前記微細糖質針を３個作製した完了状態、すなわち溶融糖質材の引き伸ばしによる微細糖質針２７が３個示されている。このように、本発明の機能剤投与デバイスの製造装置では、従来の引き伸ばし方式で必要であった溶融糖質材の押し出し用のノズルが全く不要であるため、その分低コストであり、また一度に多くの前記微細糖質針２７を前記基板６上に設けられた前記台座３上に容易に高精度で作製することができることとなる。  In the functional agent administration device manufacturing apparatus of the present invention, the carbohydrate heating container having a temperature control mechanism of 90 ° C. to 120 ° C., and the elevation control capable of attaching the substrate so that the pedestal points in the vertically downward direction Preferably, the stage includes a mechanism along a horizontal plane, and further includes the stage having an alignment control mechanism that arbitrarily positions a distance between the upper surface of the base and the upper surface of the molten carbohydrate. As the sugar heating container, as described above, a stainless steel heating container having a constant temperature characteristic or the like can be suitably used because it stably maintains the sugar melting temperature. In addition, this alignment control mechanism is capable of detecting a fine position, for example, detecting the interference intensity of a laser beam that fluctuates depending on the wavelength size, an encoder that uses light, and a caliper for a mechanical type. An alignment control device using a mechanism or the like can be suitably used. FIG. 11 is a schematic diagram showing a state in the process of producing a fine sugar needle by a fine sugar needle manufacturing apparatus based on a conventional stretching method. In FIG. 11, this is provided in the molten sugar material supply machine 17. After the molten sugar material 19 is pushed out from the two nozzles 18 onto the substrate 2 heated by the substrate heater 20, the molten sugar material 19 is stretched by the elevation control mechanism 16 of the molten sugar material supply machine. 2 shows a state in which two of the fine sugar needles 1 are being produced. On the substrate 2, two fine sugar needles 1 have been produced, and two of them are being produced. Has been. In the conventional fine sugar needle manufacturing apparatus based on such a stretching method, it is difficult to provide the high-precision processed nozzle 18 in the molten sugar material supply machine 17 and the cost is correspondingly high. It can be understood that it is difficult to fabricate a quality needle on the substrate 2. Incidentally, in FIG. 11, in order to clarify the saccharide material, the saccharide material is illustrated with shading by dot display, but this is the same in FIGS. 12 and 13 below. FIG. 12 is a schematic diagram showing a state in the process of producing a fine sugar needle by the apparatus for producing a functional agent administration device of the present invention. In this figure, on the substrate 6 made of a polysaccharide, the mold is molded. After the three pedestals 3 made of the polysaccharides are molded, the substrate 6 is mounted on the substrate mounting stage 22 that has the elevation control mechanism 21 of the substrate mounting stage along the horizontal plane so that the pedestal 3 points in the vertically downward direction. After the upper surface of the pedestal 3 is brought into contact with the upper surface of the molten saccharide (the molten saccharide material 19) in the saccharide heating container 23 whose temperature is controlled to 90 ° C. to 120 ° C. in a stationary state, the stage A state in which three fine sugar needles are being produced on the upper surface of the pedestal 3 by moving up and down 22, that is, three fine sugar needles 24 in the middle of stretching the molten sugar material are shown. Incidentally, in this figure, the stage 22 serves as an alignment control mechanism for arbitrarily positioning the distance between the pedestal 3 and the upper surface of the molten saccharide (the molten saccharide material 19). Although it has a mechanism 25, it should be noted that the control mechanism 25 schematically shows a state in which the reciprocating laser beam 26 is irradiated vertically downward to position the distance. The reciprocating laser beam 26 is used for arbitrarily positioning the distance between the pedestal upper surface 4 and the upper surface of the molten sugar material 19. Instead, as shown in FIG. 12, the stage surface (the surface on which the substrate is not attached) is irradiated with a reciprocating laser beam to measure the stage position. For example, the upper surface of the pedestal is left stationary. The stage position at the time of contact with the upper surface of the molten sugar in the state is measured by the reciprocating laser beam 26 as a reference position, and the movement distance of the pedestal from the reference position is measured using the alignment control mechanism 25 by laser beam interference. Just fine-tune. The control mechanism 25 controls the raising / lowering of the stage position, that is, the raising / lowering of the pedestal upper surface 4 in contact with the molten sugar material 19, so that the shape of the fine sugar needle is substantially cone, bell, jewel, It will be made in the shape of a polygonal pyramid, an approximate bell, and an approximate jewel. Furthermore, FIG. 13 is a schematic diagram showing a completed production state of a fine sugar needle by the apparatus for manufacturing a functional agent administration device of the present invention. In this figure, the upper surface of the pedestal 3 is lifted by moving the stage 22 up and down. 3 shows a completed state in which three fine sugar needles are produced, that is, three fine sugar needles 27 by stretching a molten sugar material. As described above, in the apparatus for manufacturing a functional agent administration device of the present invention, the nozzle for extruding the molten sugar material, which was necessary in the conventional stretching method, is completely unnecessary. In addition, a large number of the fine sugar needles 27 can be easily manufactured with high accuracy on the base 3 provided on the substrate 6.

本発明について以下に実施例により具体的説明を行うが、本発明は以下の実施例に何ら限定されるものではない。  EXAMPLES The present invention will be specifically described below with reference to examples, but the present invention is not limited to the following examples.

栄養剤投与デバイスの作製及び皮膚内挿入試験
台座及び基板を一体化製造するべく、所定の金型成形加工により、プルランからなる基板（縦横長さ共に５ｍｍの正方形状、厚さ５００μｍ）上に、プルランからなる台座（略円柱形状にて、台座高さ１００μｍ、台座上面の直径３００μｍ、台座底面の直径４００μｍである）を縦３列及び横３列でピッチ１ｍｍ間隔にて各列で３個ずつ計９個作製（その外形の概略は図２に示された通り）した。これらの台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の１００℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（略円錐形状にて、針先端の直径５μｍ、針長さ６００μｍ、針底面の直径３００μｍである）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する栄養剤投与デバイスを作製（その外形及び断面の概略は図３及び図４に示された通り）した。尚、本実施例における製造方法及び製造装置の概略を示す模式図は、図１２及び図１３に示された通りであり、ステージ昇降を微調整する制御方法には、コンピュータより所定信号を得て駆動する数値制御方法を用い、前記台座上面と溶融した前記糖質の上面との距離を任意に位置決めする位置合わせ制御機構には、レーザ光の干渉強度の検出を利用した位置合わせ制御機構を使用し、以下の実施例２〜実施例１２においても同様とした。但し、図１２及び図１３には簡略化の為に、略円錐形状の微細糖質針を図示している点に留意すべきである。次に、本栄養剤投与デバイスについて皮膚内挿入試験を行なうべく、微細糖質針に指があたらない様に基板の向い合う両端部を二指で挟み、被験者の左腕上腕皮膚部位に微細糖質針があたるように、前記皮膚部位を本栄養剤投与デバイスで押さえて微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．１３ｍｇのマルトースを投与すること）ができた。本皮膚内挿入試験により、皮膚内に残留した微細糖質針は溶解し、栄養剤として体内に吸収されることとなり、また挿入後に本栄養剤投与デバイスを前記皮膚部位から引き離したところ、前記皮膚部位に傷跡は残らなかったが、これらは以下の実施例１〜実施例６においても同様であった。Preparation of nutritional administration device and insertion test in skin In order to integrally manufacture pedestal and substrate, on a substrate made of pullulan (a square shape of 5 mm in length and width, thickness 500 μm) by a predetermined mold forming process, Three pedestals made of pullulan (substantially cylindrical, pedestal height 100 μm, pedestal top diameter 300 μm, pedestal bottom diameter 400 μm) in three rows and three rows in each row at a pitch of 1 mm. A total of nine were produced (the outline of the outline is as shown in FIG. 2). The board | substrate with which these bases were provided was attached to the stage which has a raising / lowering control mechanism and follows a horizontal surface so that these bases may point a perpendicular downward direction. Next, after these upper surfaces of the pedestal are brought into contact with the upper surface of the molten saccharide (using maltose in this embodiment) in a saccharide heating container whose temperature is controlled to 100 ° C. in a stationary state, the stage is moved to a predetermined state. By controlling the elevation, fine sugar needles (in a substantially conical shape, having a needle tip diameter of 5 μm, a needle length of 600 μm, and a needle bottom diameter of 300 μm) are simultaneously molded one by one, that is, A nutrient solution administration device having nine fine sugar needles at a time was prepared (the outline of the outline and the cross section is as shown in FIGS. 3 and 4). In addition, the schematic diagram which shows the outline of the manufacturing method and manufacturing apparatus in a present Example is as having shown by FIG.12 and FIG.13, and a predetermined signal is obtained from the computer in the control method which finely adjusts stage raising / lowering. A positioning control mechanism that uses the detection of the interference intensity of laser light is used for the positioning control mechanism that arbitrarily positions the distance between the top surface of the pedestal and the top surface of the melted carbohydrate by using a numerical control method for driving. The same applies to Examples 2 to 12 below. However, it should be noted that in FIG. 12 and FIG. 13, a substantially conical fine sugar needle is illustrated for the sake of simplicity. Next, in order to perform an intradermal insertion test on this nutrient solution administration device, the opposite ends of the substrate are sandwiched with two fingers so that the finger does not touch the fine sugar needle, and the fine carbohydrate is placed on the left arm upper arm skin site of the subject. When the fine saccharide needle is inserted into the skin by pressing the skin part with this nutrient solution administration device so that the needle hits, the skin can be inserted painlessly and all fine saccharide needles remain in the skin. (That is, about 0.13 mg of maltose was administered into the body). In this skin insertion test, the fine sugar needle remaining in the skin dissolves and is absorbed into the body as a nutrient, and when the nutrient administration device is pulled away from the skin site after insertion, the skin Although no scar was left on the site, these were the same in Examples 1 to 6 below.

栄養剤投与デバイスの作製及び皮膚内挿入試験
台座及び基板を分離製造するべく、所定の金型成形加工により、プルランからなる基板（縦横長さ共に５ｍｍの正方形状、厚さ５００μｍ）上に、カルボキシメチルセルロース（ＣＭＣ）からなる台座（略円柱形状にて、台座高さ１００μｍ、台座上面の直径３００μｍ、台座底面の直径４００μｍである）を縦３列及び横３列でピッチ１ｍｍ間隔にて各列で３個ずつ計９個作製（その外形の概略は図２に示された通り）した。これらの台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の９５℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１０重量％グルコースを混合させた糖質混合物を使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（釣鐘形状にて、針先端の直径７μｍ、針長さ６００μｍ、針底面の直径３００μｍである）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する栄養剤投与デバイスを作製（その外形の概略は図６に示された通り）した。次に、本栄養剤投与デバイスについて皮膚内挿入試験を行なうべく、実施例１と同様にして微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．１７ｍｇのマルトースと約０．０２ｍｇのグルコースを同時に投与すること）ができた。Preparation of nutrient solution administration device and skin insertion test In order to separate and manufacture the pedestal and the substrate, a predetermined mold molding process was carried out on a substrate made of pullulan (a square shape 5 mm in length and width, thickness 500 μm). Pedestals made of methylcellulose (CMC) (substantially cylindrical, with a pedestal height of 100 μm, a pedestal top diameter of 300 μm, and a pedestal bottom diameter of 400 μm) are arranged in 3 rows and 3 rows in a 1 mm pitch interval in each row. Nine pieces were produced in total (three outlines as outlined in FIG. 2). The board | substrate with which these bases were provided was attached to the stage which has a raising / lowering control mechanism and follows a horizontal surface so that these bases may point a perpendicular downward direction. Next, the top surface of these pedestals was allowed to stand in a stationary state at a temperature of 95 ° C. in a heated saccharide container (in this example, a sugar mixture in which 10% by weight glucose was mixed with maltose was used). After making contact with the upper surface, the stage is controlled to move up and down in a predetermined manner, whereby fine sugar needles (with a bell shape, a needle tip diameter of 7 μm, a needle length of 600 μm, and a needle bottom surface diameter of 300 μm are controlled on the pedestal. One) was molded at a time, that is, a nutrient administration device having nine fine saccharide needles at a time (the outline of the outline was as shown in FIG. 6). Next, in order to conduct a skin insertion test on the nutrient solution administration device, when a fine saccharide needle was inserted into the skin in the same manner as in Example 1, it was possible to insert the skin in a painless state, and all the fine sugars entered the skin. The needle could be left (ie, about 0.17 mg of maltose and about 0.02 mg of glucose administered simultaneously in the body).

栄養剤投与デバイスの作製及び皮膚内挿入試験
台座及び基板を一体化製造するべく、所定の金型成形加工により、プルランからなる基板（縦横長さ共に５ｍｍの正方形状、厚さ５００μｍ）上に、プルランからなる台座（略円柱形状にて、台座高さ１００μｍ、台座上面の直径３００μｍ、台座底面の直径４００μｍである）を縦３列及び横３列でピッチ１ｍｍ間隔にて各列で３個ずつ計９個作製（その外形の概略は図２に示された通り）した。これらの台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の１１０℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに３重量％トレハロースを混合させた糖質混合物を使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（宝珠形状にて、針先端の直径７μｍ、針長さ６００μｍ、針底面の直径３００μｍ、針長さ方向における略中間部の最大直径が５００μｍである）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する栄養剤投与デバイスを作製（その外形の概略は図７に示された通り）した。次に、本栄養剤投与デバイスについて皮膚内挿入試験を行なうべく、実施例１と同様にして微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．２ｍｇのマルトースと約６μｇのトレハロースを同時に投与すること）ができた。Preparation of nutritional administration device and insertion test in skin In order to integrally manufacture pedestal and substrate, on a substrate made of pullulan (a square shape of 5 mm in length and width, thickness 500 μm) by a predetermined mold forming process, Three pedestals made of pullulan (substantially cylindrical, pedestal height 100 μm, pedestal top diameter 300 μm, pedestal bottom diameter 400 μm) in three rows and three rows in each row at a pitch of 1 mm. A total of nine were produced (the outline of the outline is as shown in FIG. 2). The board | substrate with which these bases were provided was attached to the stage which has a raising / lowering control mechanism and follows a horizontal surface so that these bases may point a perpendicular downward direction. Next, the molten sugar in a sugar heating container whose temperature is controlled to 110 ° C. with the pedestal upper surface being stationary (in this example, a sugar mixture in which 3 wt% trehalose is mixed with maltose is used) After making contact with the upper surface, the stage is controlled to move up and down in a predetermined manner, whereby fine sugar needles (in the shape of jewels, with a needle tip diameter of 7 μm, a needle length of 600 μm, a needle bottom diameter of 300 μm, (The maximum diameter of the substantially middle part in the needle length direction is 500 μm), one by one, that is, a nutrient administration device having nine fine sugar needles at a time is manufactured (the outline of the outline is shown in FIG. 7). As indicated). Next, in order to conduct a skin insertion test on the nutrient solution administration device, when a fine saccharide needle was inserted into the skin in the same manner as in Example 1, it was possible to insert the skin in a painless state, and all the fine sugars entered the skin. The needle could be left (ie, about 0.2 mg of maltose and about 6 μg of trehalose were administered simultaneously in the body).

栄養剤投与デバイスの作製及び皮膚内挿入試験
台座及び基板を一体化製造するべく、所定の金型成形加工により、プルランからなる基板（縦横長さ共に５ｍｍの正方形状、厚さ５００μｍ）上に、プルランからなる台座（略四角柱形状にて、台座高さ１００μｍ、直径４２４μｍの円に内接する一辺３００μｍの略正方形の台座上面、直径５６５μｍの円に内接する一辺４００μｍの略正方形の台座底面である）を縦３列及び横３列でピッチ１ｍｍ間隔にて各列で３個ずつ計９個作製した。これらの台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の１００℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに５重量％アスコルビン酸リン酸マグネシウム（ビタミンＣ）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（略四角錐形状にて、針先端の直径５μｍ、針長さ６００μｍ、針底面が該台座上面と同一の略正方形状である）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する栄養剤投与デバイスを作製（その外形の概略は図８に示された通り）した。次に、本栄養剤投与デバイスについて皮膚内挿入試験を行なうべく、微細糖質針に指があたらない様に基板の向い合う両端部を二指で挟み、被験者の顔皮膚のシミ部位に微細糖質針があたるように、前記シミ部位を本栄養剤投与デバイスで押さえて微細糖質針を顔皮膚内に挿入したところ、無痛状態で皮膚挿入でき、顔皮膚内に全ての微細糖質針を残留させること（すなわち、顔皮膚内に約０．１６ｍｇのマルトースと約８μｇのアスコルビン酸リン酸マグネシウムを同時に投与すること）ができた。また、本皮膚内挿入試験を週一回にて３ヶ月続けたところ、前記のビタミンＣ投与により、前記シミ部位についてシミを目立たないところまで薄める効果があることが確認された。Preparation of nutritional administration device and insertion test in skin In order to integrally manufacture pedestal and substrate, on a substrate made of pullulan (a square shape of 5 mm in length and width, thickness 500 μm) by a predetermined mold forming process, A pedestal made of pullulan (substantially square column shape, pedestal height 100 μm, inferior to a circle having a diameter of 424 μm, a substantially square pedestal top surface with a side of 300 μm, and a bottom surface of a substantially square pedestal with 400 μm side inscribed in a circle with a diameter of 565 μm. ) Was produced in a total of 9 pieces in 3 rows and 3 rows in each row at a pitch of 1 mm. The board | substrate with which these bases were provided was attached to the stage which has a raising / lowering control mechanism and follows a horizontal surface so that these bases may point a perpendicular downward direction. Next, these pedestal upper surfaces were allowed to stand, and the molten sugar in a sugar heating container whose temperature was controlled at 100 ° C. (in this example, maltose was mixed with 5 wt% magnesium ascorbate phosphate (vitamin C)). After making contact with the upper surface of the sample, the stage is controlled to move up and down in a predetermined manner, so that fine sugar needles (approximately quadrangular pyramid shape, needle tip diameter of 5 μm, needle length) 600 μm, the bottom of the needle is the same square shape as the top of the pedestal), one by one, that is, a nutrient administration device having nine fine sugar needles at a time (the outline of the outline is shown in the figure) 8). Next, in order to conduct a skin insertion test on the nutrient solution administration device, the opposite ends of the substrate are sandwiched with two fingers so that the finger does not touch the fine sugar needle, and the fine sugar is applied to the spot on the subject's face skin. When the fine sugar needle is inserted into the facial skin by pressing the stain site with this nutrient solution administration device so that the needle touches, the skin can be inserted painlessly, and all fine sugar needles are placed in the facial skin. (Ie, about 0.16 mg of maltose and about 8 μg of magnesium ascorbate phosphate were simultaneously administered into the facial skin). Further, when this intradermal insertion test was continued once a week for 3 months, it was confirmed that the above-mentioned vitamin C administration had an effect of thinning the stain site to an inconspicuous place.

栄養剤投与デバイスの作製及び皮膚内挿入試験
台座及び基板を一体化製造するべく、所定の金型成形加工により、プルランからなる基板（縦横長さ共に５ｍｍの正方形状、厚さ５００μｍ）上に、プルランからなる台座（略四角柱形状にて、台座高さ１００μｍ、直径４２４μｍの円に内接する一辺３００μｍの略正方形の台座上面、直径５６５μｍの円に内接する一辺４００μｍの略正方形の台座底面である）を縦３列及び横３列でピッチ１ｍｍ間隔にて各列で３個ずつ計９個作製した。これらの台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の１００℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１０重量％レチノール（ビタミンＡ）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（略釣鐘形状にて、針先端の直径７μｍ、針長さ６００μｍ、針底面が該台座上面と同一の略正方形状である）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する栄養剤投与デバイスを作製（その外形の概略は図９に示された通り）した。次に、本栄養剤投与デバイスについて皮膚内挿入試験を行なうべく、微細糖質針に指があたらない様に基板の向い合う両端部を二指で挟み、被験者の左腕上腕皮膚部位に微細糖質針があたるように、前記皮膚部位を本栄養剤投与デバイスで押さえて微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．１９ｍｇのマルトースと約２０μｇのレチノールを同時に投与すること）ができた。Preparation of nutritional administration device and insertion test in skin In order to integrally manufacture pedestal and substrate, on a substrate made of pullulan (a square shape of 5 mm in length and width, thickness 500 μm) by a predetermined mold forming process, A pedestal made of pullulan (substantially square column shape, pedestal height 100 μm, inferior to a circle having a diameter of 424 μm, a substantially square pedestal top surface with a side of 300 μm, and a bottom surface of a substantially square pedestal with 400 μm side inscribed in a circle with a diameter of 565 μm. ) Was produced in a total of 9 pieces in 3 rows and 3 rows in each row at a pitch of 1 mm. The board | substrate with which these bases were provided was attached to the stage which has a raising / lowering control mechanism and follows a horizontal surface so that these bases may point a perpendicular downward direction. Next, molten saccharides in a saccharide heating container whose temperature is controlled to 100 ° C. with the pedestal upper surface stationary (in this example, maltose containing 10 wt% retinol (vitamin A) is used. ), The stage is controlled to move up and down in a predetermined manner, whereby a fine sugar needle (substantially bell-shaped, needle tip diameter 7 μm, needle length 600 μm, needle bottom The same shape as the upper surface of the pedestal is formed at the same time, ie, a nutrient administration device having nine fine sugar needles at a time (the outline of the outline is shown in FIG. 9). Street). Next, in order to perform an intradermal insertion test on this nutrient solution administration device, the opposite ends of the substrate are sandwiched with two fingers so that the finger does not touch the fine sugar needle, and the fine carbohydrate is placed on the left arm upper arm skin site of the subject. When the fine saccharide needle is inserted into the skin by pressing the skin part with this nutrient solution administration device so that the needle hits, the skin can be inserted painlessly and all fine saccharide needles remain in the skin. (That is, about 0.19 mg of maltose and about 20 μg of retinol were simultaneously administered into the body).

栄養剤投与デバイスの作製及び皮膚内挿入試験
台座及び基板を一体化製造するべく、所定の金型成形加工により、プルランからなる基板（縦横長さ共に５ｍｍの正方形状、厚さ５００μｍ）上に、プルランからなる台座（略四角柱形状にて、台座高さ１００μｍ、直径４２４μｍの円に内接する一辺３００μｍの正方形の台座上面、直径５６５μｍの円に内接する一辺４００μｍの正方形の台座底面である）を縦３列及び横３列でピッチ１ｍｍ間隔にて各列で３個ずつ計９個作製した。これらの台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の９５℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１０重量％ナイアシン（ビタミンＢ複合体）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（略宝珠形状にて、針先端の直径７μｍ、針長さ６００μｍ、針底面が該台座上面と同一の略正方形状で、針長さ方向における略中間部が直径７０７μｍの円に内接する一辺５００μｍの略正方形である）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する栄養剤投与デバイスを作製（その外形の概略は図１０に示された通り）した。次に、本栄養剤投与デバイスについて皮膚内挿入試験を行なうべく、実施例５と同様にして微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．２３ｍｇのマルトースと約２５μｇのナイアシンを同時に投与すること）ができた。Preparation of nutritional administration device and insertion test in skin In order to integrally manufacture pedestal and substrate, on a substrate made of pullulan (a square shape of 5 mm in length and width, thickness 500 μm) by a predetermined mold forming process, A pedestal made of pullulan (in the shape of a substantially quadrangular prism, a pedestal height of 100 μm, a square pedestal with a side of 300 μm inscribed in a circle with a diameter of 424 μm, and a square pedestal bottom with a side of 400 μm inscribed in a circle with a diameter of 565 μm) A total of 9 pieces were produced, 3 in each row and 3 in each row at a pitch of 1 mm in 3 rows and 3 rows. The board | substrate with which these bases were provided was attached to the stage which has a raising / lowering control mechanism and follows a horizontal surface so that these bases may point a perpendicular downward direction. Next, molten saccharides (in this example, maltose containing 10% by weight niacin (vitamin B complex) in a saccharide heating container whose temperature was controlled at 95 ° C. while the upper surfaces of the pedestals were allowed to stand were controlled. Are used, and the stage is controlled to be moved up and down in a predetermined manner, whereby fine sugar needles (substantially jewel-shaped, needle tip diameter of 7 μm, needle length of 600 μm, needles) The bottom surface is substantially the same square shape as the top surface of the pedestal, and the substantially middle portion in the needle length direction is a substantially square having a side of 500 μm inscribed in a circle having a diameter of 707 μm). A nutrient solution administration device having a fine saccharide needle was prepared (the outline of the outline was as shown in FIG. 10). Next, in order to conduct a skin insertion test on the nutrient solution administration device, when a fine saccharide needle was inserted into the skin in the same manner as in Example 5, it was possible to insert the skin in a painless state, and all the fine sugars entered the skin. The needle could be left (ie, about 0.23 mg maltose and about 25 μg niacin administered simultaneously in the body).

医薬剤投与デバイスの作製及び皮膚内挿入試験
実施例１と同様にして、台座及び基板を一体化製造し、これら９個の台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の１００℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１重量％インドメタシン（消炎薬剤）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（略円錐形状にて、針先端の直径５μｍ、針長さ６００μｍ、針底面の直径３００μｍである）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する医薬剤投与デバイスを作製（その外形及び断面の概略は図３及び図４に示された通り）した。次に、本医薬剤投与デバイスについて皮膚内挿入試験を行なうべく、微細糖質針に指があたらない様に基板の向い合う両端部を二指で挟み、被験者の打ち身による痛みを伴う左腕上腕皮膚部位に微細糖質針があたるように、前記皮膚部位を本医薬剤投与デバイスで押さえて微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．１３ｍｇのマルトースと約１．３μｇのインドメタシンを投与すること）ができた。また、本皮膚内挿入試験後、暫くして徐々に被験者の打ち身による痛みが緩和され、インドメタシンによる消炎効果が確認された。本皮膚内挿入試験により、皮膚内に残留した微細糖質針の主成分は溶解し、栄養剤及び医薬剤が体内に吸収されることとなり、また挿入後に本医薬剤投与デバイスを前記皮膚部位から引き離したところ、前記皮膚部位に傷跡は残らなかったが、これらは以下の実施例７〜実施例１２においても同様であった。Production of pharmaceutical agent administration device and insertion test into skin In the same manner as in Example 1, a pedestal and a substrate were integrally manufactured, and a substrate provided with these nine pedestals was provided with a lift control mechanism along a horizontal plane. These pedestals were attached so as to point in the vertically downward direction. Next, melted saccharides in a saccharide heating container whose temperature is controlled to 100 ° C. with the pedestal upper surface stationary (in this example, maltose containing 1 wt% indomethacin (anti-inflammatory drug)) is used. ), The stage is controlled to move up and down in a predetermined manner, so that fine sugar needles (approximately conical shape, needle tip diameter 5 μm, needle length 600 μm, needle bottom surface) (With a diameter of 300 μm) are molded at the same time, that is, a pharmaceutical agent administration device having nine fine sugar needles at a time is produced (the outline and cross section are schematically shown in FIGS. 3 and 4). did. Next, in order to conduct an intradermal insertion test for the pharmaceutical agent administration device, the opposite arm of the substrate is sandwiched with two fingers so that the finger does not touch the fine sugar needle, and the left upper arm skin with pain due to the subject's bruise When the fine saccharide needle is inserted into the skin by pressing the skin part with the present pharmaceutical agent administration device so that the fine saccharide needle hits the part, the skin can be inserted painlessly, and all fine saccharides in the skin The needle was allowed to remain (ie, about 0.13 mg maltose and about 1.3 μg indomethacin were administered into the body). In addition, the pain due to the subject's bruise was gradually relieved for a while after the intradermal insertion test, and the anti-inflammatory effect of indomethacin was confirmed. According to this intradermal insertion test, the main component of the fine sugar needle remaining in the skin is dissolved, and the nutrient and pharmaceutical agent are absorbed into the body, and after the insertion, the pharmaceutical agent administration device is removed from the skin site. When pulled apart, no scars were left on the skin site, but these were the same in Examples 7 to 12 below.

医薬剤投与デバイスの作製及び皮膚内挿入試験
実施例２と同様にして、台座及び基板を分離製造し、これら９個の台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の１００℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１重量％リドカイン（麻酔剤）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（釣鐘形状にて、針先端の直径７μｍ、針長さ６００μｍ、針底面の直径３００μｍである）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する医薬剤投与デバイスを作製（その外形の概略は図６に示された通り）した。次に、本医薬剤投与デバイスについて皮膚内挿入試験を行なうべく、微細糖質針に指があたらない様に基板の向い合う両端部を二指で挟み、被験者の右腕上腕皮膚部位に微細糖質針があたるように、前記皮膚部位を本医薬剤投与デバイスで押さえて微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．１６ｍｇのマルトースと約１．６μｇのリドカインを同時に投与すること）ができた。また、本皮膚内挿入試験後、徐々に被験者の前記皮膚部位の感覚が麻痺し、リドカインによる麻酔効果が確認された。Preparation of pharmaceutical agent administration device and skin insertion test In the same manner as in Example 2, the pedestal and the substrate were separately manufactured, and the substrate provided with these nine pedestals was placed on a stage having a lifting control mechanism along a horizontal plane. These pedestals were attached so as to point vertically downward. Next, molten saccharides in a saccharide heating container whose temperature is controlled to 100 ° C. with the pedestal upper surface being stationary (in this embodiment, maltose containing 1 wt% lidocaine (anesthetic agent) is used. ) And then the stage is controlled to move up and down in a predetermined manner, whereby fine sugar needles (with a bell shape, needle tip diameter 7 μm, needle length 600 μm, needle bottom diameter) 300 μm) were simultaneously molded one by one, that is, a pharmaceutical agent administration device having nine fine sugar needles at a time was produced (the outline of the outline is as shown in FIG. 6). Next, in order to perform an intradermal insertion test on this pharmaceutical agent administration device, the opposite ends of the substrate are sandwiched with two fingers so that the finger does not touch the fine sugar needle, and the fine sugar is placed on the skin of the right arm upper arm of the subject. When the fine saccharide needle is inserted into the skin by pressing the skin site with this pharmaceutical agent administration device so that the needle hits, the skin can be inserted painlessly and all fine saccharide needles remain in the skin. (That is, about 0.16 mg of maltose and about 1.6 μg of lidocaine were simultaneously administered into the body). In addition, after this intracutaneous test, the sensation of the skin part of the subject gradually became paralyzed, and the anesthetic effect by lidocaine was confirmed.

医薬剤投与デバイスの作製及び皮膚内挿入試験
実施例３と同様にして、台座及び基板を一体化製造し、これら９個の台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の９５℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１重量％塩酸ジフェンヒドラミン（酔い止め薬）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（宝珠形状にて、針先端の直径７μｍ、針長さ６００μｍ、針底面の直径３００μｍ、針長さ方向における略中間部の最大直径が５００μｍである）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する医薬剤投与デバイスを作製（その外形の概略は図７に示された通り）した。次に、本医薬剤投与デバイスについて皮膚内挿入試験を行なうべく、微細糖質針に指があたらない様に基板の向い合う両端部を二指で挟み、車酔いしている被験者の左腕上腕皮膚部位に微細糖質針があたるように、前記皮膚部位を本医薬剤投与デバイスで押さえて微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．１９ｍｇのマルトースと約１．９μｇの塩酸ジフェンヒドラミンを同時に投与すること）ができた。また、本皮膚内挿入試験後、暫くして徐々に被験者の車酔いは改善され、塩酸ジフェンヒドラミンによる酔い止め効果が確認された。Preparation of pharmaceutical agent administration device and insertion test in skin In the same manner as in Example 3, a base and a substrate were manufactured in an integrated manner, and the substrate provided with these nine bases was provided with a lift control mechanism along a horizontal plane. These pedestals were attached so as to point in the vertically downward direction. Next, these pedestal upper surfaces were allowed to stand in a stationary state and were heated in a sugar-heated container whose temperature was controlled to 95 ° C. (in this example, maltose contained 1% by weight diphenhydramine hydrochloride (sickness medicine)) Are used, and the stage is controlled to move up and down in a predetermined manner, whereby fine sugar needles (jewel-shaped, needle tip diameter 7 μm, needle length 600 μm, needle bottom surface) Each having a diameter of 300 μm and a maximum diameter of approximately the middle part in the needle length direction of 500 μm), one at a time, that is, producing a pharmaceutical agent administration device having nine fine sugar needles at one time The outline is as shown in FIG. Next, in order to conduct an intracutaneous insertion test for this pharmaceutical agent administration device, the opposite arm of the substrate is sandwiched between two fingers so that the finger does not touch the fine sugar needle, and the left arm upper arm skin of a subject who is intoxicated When the fine saccharide needle is inserted into the skin by pressing the skin part with the present pharmaceutical agent administration device so that the fine saccharide needle hits the part, the skin can be inserted painlessly, and all fine saccharides in the skin The needle was allowed to remain (ie, about 0.19 mg maltose and about 1.9 μg diphenhydramine hydrochloride were administered simultaneously in the body). In addition, after the insertion test in the skin, the car sickness of the subject gradually improved after a while, and the effect of sickness prevention by diphenhydramine hydrochloride was confirmed.

医薬剤投与デバイスの作製及び皮膚内挿入試験
実施例４と同様にして、台座及び基板を一体化製造し、これら９個の台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の１００℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１重量％ウロキナーゼ（血栓溶解剤）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（略四角錐形状にて、針先端の直径５μｍ、針長さ６００μｍ、針底面が該台座上面と同一の略正方形状である）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する栄養剤投与デバイスを作製（その外形の概略は図８に示された通り）した。次に、本医薬剤投与デバイスについて皮膚内挿入試験を行なうべく、微細糖質針に指があたらない様に基板の向い合う両端部を二指で挟み、被験者の顔頬の皮膚部位に微細糖質針があたるように、前記皮膚部位を本医薬剤投与デバイスで押さえて微細糖質針を頬皮膚内に挿入したところ、無痛状態で皮膚挿入でき、頬皮膚内に全ての微細糖質針を残留させること（すなわち、頬皮膚内に約０．１５ｍｇのマルトースと約１．５μｇのウロキナーゼを同時に投与すること）ができた。また、本皮膚内挿入試験後、前記の頬皮膚部位にて採取した血液の顕微鏡観察より、血栓の溶解現象を観察することができ、ウロキナーゼによる血栓溶解効果が確認された。Production of pharmaceutical agent administration device and insertion test in skin In the same manner as in Example 4, a base and a substrate are manufactured integrally, and a substrate provided with these nine bases is provided with a lift control mechanism and a stage along a horizontal plane. These pedestals were attached so as to point in the vertically downward direction. Next, these pedestal upper surfaces were allowed to stand in a stationary state and heated in a sugar heating container whose temperature was controlled at 100 ° C. (in this example, maltose containing 1 wt% urokinase (thrombolytic agent)) After making contact with the upper surface of the use, the stage is controlled to move up and down in a predetermined manner, whereby a fine carbohydrate needle (approximately quadrangular pyramid shape, needle tip diameter 5 μm, needle length 600 μm, The bottom surface is substantially the same square shape as the top surface of the pedestal, and is simultaneously molded one by one, that is, a nutrient administration device having nine fine sugar needles at a time is produced (the outline of the outline is shown in FIG. 8). As you did). Next, in order to perform an intracutaneous insertion test on this pharmaceutical agent administration device, the opposite ends of the substrate are sandwiched with two fingers so that the finger does not touch the fine sugar needle, and the fine sugar is applied to the skin region of the subject's face cheek. When the fine saccharide needle is inserted into the buccal skin while pressing the skin part with this pharmaceutical agent administration device so that the needle touches, the skin can be inserted painlessly, and all the fine saccharide needles are placed in the buccal skin. Could be left (ie, about 0.15 mg maltose and about 1.5 μg urokinase administered simultaneously in the buccal skin). In addition, after the intradermal test, the thrombus dissolution phenomenon could be observed by microscopic observation of blood collected at the cheek skin site, and the thrombolytic effect of urokinase was confirmed.

医薬剤投与デバイスの作製及び皮膚内挿入試験
実施例５と同様にして、台座及び基板を一体化製造し、これら９個の台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の９５℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１重量％トリアゾラム（睡眠薬）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（略釣鐘形状にて、針先端の直径７μｍ、針長さ６００μｍ、針底面が該台座上面と同一の略正方形状である）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する栄養剤投与デバイスを作製（その外形の概略は図９に示された通り）した。次に、本医薬剤投与デバイスについて皮膚内挿入試験を行なうべく、微細糖質針に指があたらない様に基板の向い合う両端部を二指で挟み、被験者の左腕上腕皮膚部位に微細糖質針があたるように、前記皮膚部位を本医薬剤投与デバイスで押さえて微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．１８ｍｇのマルトースと約１．８μｇのトリアゾラムを同時に投与すること）ができた。また、本皮膚内挿入試験が終了して６０分後、被験者は眠気を感じて暫時眠ることとなり、トリアゾラムによる睡眠効果が確認された。Preparation of pharmaceutical agent administration device and insertion test into skin In the same manner as in Example 5, the pedestal and the substrate were integrally manufactured, and the substrate provided with these nine pedestals was equipped with a lift control mechanism along a horizontal plane. These pedestals were attached so as to point in the vertically downward direction. Next, molten sugar in a sugar heating container whose temperature is controlled to 95 ° C. with the upper surface of the pedestal stationary (in this example, maltose containing 1 wt% triazolam (sleeping medicine) is used) After making contact with the upper surface of the needle, the stage is controlled to move up and down in a predetermined manner, whereby fine sugar needles (approximately bell-shaped, needle tip diameter 7 μm, needle length 600 μm, needle bottom surface The same shape as the upper surface of the pedestal is formed at the same time, that is, a nutrient administration device having nine fine sugar needles at a time is manufactured (the outline of the outline is as shown in FIG. 9). )did. Next, in order to perform an intradermal insertion test for this pharmaceutical agent administration device, the opposite ends of the substrate are sandwiched with two fingers so that the finger does not touch the fine sugar needle, and the fine sugar is placed on the left arm upper arm skin site of the subject. When the fine saccharide needle is inserted into the skin by pressing the skin site with this pharmaceutical agent administration device so that the needle hits, the skin can be inserted painlessly and all fine saccharide needles remain in the skin. (That is, about 0.18 mg of maltose and about 1.8 μg of triazolam were simultaneously administered into the body). In addition, 60 minutes after the completion of the intradermal insertion test, the subject felt sleepy and slept for a while, and the sleep effect of triazolam was confirmed.

医薬剤投与デバイスの作製及び皮膚内挿入試験
実施例６と同様にして、台座及び基板を一体化製造し、これら９個の台座が設けられた基板を、昇降制御機構を有し水平面に沿うステージに、これらの台座が鉛直下向き方向を指すように取り付けた。次に、これら台座上面を静置状態の９５℃に温度制御された糖質加熱容器内の溶融した糖質（本実施例ではマルトースに１重量％トリクロルメチアジド（高血圧治療薬）を含有させたものを使用）の上面に接触させた後、前記ステージを所定の昇降制御することにより、これら各台座上面に微細糖質針（略宝珠形状にて、針先端の直径７μｍ、針長さ６００μｍ、針底面が該台座上面と同一の略正方形状で、針長さ方向における略中間部が直径７０７μｍの円に内接する一辺５００μｍの略正方形である）を１個ずつ同時に成形し、すなわち一度に９個の微細糖質針を有する医薬剤投与デバイスを作製（その外形の概略は図１０に示された通り）した。次に、本医薬剤投与デバイスについて皮膚内挿入試験を行なうべく、実施例１１と同様にして微細糖質針を皮膚内に挿入したところ、無痛状態で皮膚挿入でき、皮膚内に全ての微細糖質針を残留させること（すなわち、体内に約０．２２ｍｇのマルトースと約２．２μｇのトリクロルメチアジドを同時に投与すること）ができた。また、本皮膚内挿入試験が終了して４５分後、普段の平均最大血圧値が１８０Ｈｇである被験者の血圧を測定したところ、１５０Ｈｇより低い血圧域で血圧安定効果が比較的良好に現れ、最大血圧値が１６０Ｈｇ以上の危険領域に達する時間がかなり減少し、トリクロルメチアジドによる血圧の安定及び抑制効果が確認された。Preparation of pharmaceutical agent administration device and insertion test into skin In the same manner as in Example 6, the pedestal and the substrate were integrally manufactured, and the substrate provided with these nine pedestals was equipped with a lift control mechanism along a horizontal plane. These pedestals were attached so as to point in the vertically downward direction. Next, the top surface of these pedestals was allowed to stand, and the molten sugar in a sugar heating container whose temperature was controlled to 95 ° C. (in this example, maltose was allowed to contain 1 wt% trichloromethiazide (antihypertensive agent)). After making contact with the upper surface of the material used), the stage is controlled to move up and down in a predetermined manner, so that a fine sugar needle (substantially jewel-shaped, needle tip diameter 7 μm, needle length 600 μm, The needle bottom surface is substantially the same square shape as the top surface of the pedestal, and the substantially middle portion in the needle length direction is a substantially square having a side of 500 μm inscribed in a circle having a diameter of 707 μm. A pharmaceutical agent administration device having a single fine sugar needle was prepared (the outline of the outline is as shown in FIG. 10). Next, in order to conduct a skin insertion test on the pharmaceutical agent administration device, a fine saccharide needle was inserted into the skin in the same manner as in Example 11. As a result, it was possible to insert the skin in a painless state, and all the fine sugars were inserted into the skin. The needle could be left (ie, about 0.22 mg maltose and about 2.2 μg trichlormethiazide were administered simultaneously in the body). Further, 45 minutes after the completion of the intradermal insertion test, when the blood pressure of a subject whose average maximum blood pressure value is 180 Hg was measured, a blood pressure stabilizing effect appeared relatively well in a blood pressure range lower than 150 Hg, and the maximum The time to reach a dangerous area where the blood pressure value was 160 Hg or more was considerably reduced, and the effect of stabilizing and suppressing blood pressure by trichlormethiazide was confirmed.

本発明の機能剤投与デバイス、その製造方法及び製造装置は、前述の通り様々な特徴的効果を有するが、これらの効果により栄養剤や医薬剤を用いる美容分野、医療分野等において実用的に利用できる。また、本発明の機能剤投与デバイス、その製造方法及び製造装置は量産実施が可能なものであり、産業上利用できるものである。  The functional agent administration device, the production method and the production apparatus of the present invention have various characteristic effects as described above, and are practically used in the beauty field, the medical field, and the like using nutrients and pharmaceutical agents due to these effects. it can. Moreover, the functional agent administration device, the production method and the production apparatus of the present invention can be mass-produced and can be used industrially.

従来の引き伸ばし方式により基板上に設けた微細糖質針の概略図である。  It is the schematic of the fine sugar needle | hook provided on the board | substrate by the conventional extending | stretching system. 本発明の機能剤投与デバイスにおける基板上台座（略円柱形状）の概略図である。  It is the schematic of the board | substrate upper base (substantially cylindrical shape) in the functional agent administration device of this invention. 本発明の略円錐形状の微細糖質針を有する機能剤投与デバイスの概略図である。  1 is a schematic view of a functional agent administration device having a substantially conical fine sugar needle of the present invention. FIG. 台座及び基板を一体化製造した機能剤投与デバイスの断面を示す概略図である。  It is the schematic which shows the cross section of the functional agent administration device which integratedly manufactured the base and the board | substrate. 台座及び基板を分離製造した機能剤投与デバイスの断面を示す概略図である。  It is the schematic which shows the cross section of the functional agent administration device which manufactured the base and the board | substrate separately. 本発明の釣鐘形状の微細糖質針を有する機能剤投与デバイスの概略図である。  1 is a schematic view of a functional agent administration device having a bell-shaped fine sugar needle of the present invention. 本発明の宝珠形状の微細糖質針を有する機能剤投与デバイスの概略図である。  It is the schematic of the functional agent administration device which has the jewel-shaped fine sugar needle | hook of this invention. 本発明の略四角錐形状の微細糖質針を有する機能剤投与デバイスの概略図である。  1 is a schematic view of a functional agent administration device having a substantially quadrangular pyramid-shaped fine sugar needle of the present invention. FIG. 本発明の略釣鐘形状の微細糖質針を有する機能剤投与デバイスの概略図である。  1 is a schematic view of a functional agent administration device having a substantially sugar-shaped fine sugar needle of the present invention. 本発明の略宝珠形状の微細糖質針を有する機能剤投与デバイスの概略図である。  It is the schematic of the functional agent administration device which has a substantially jewel-shaped fine sugar needle of the present invention. 従来の引き伸ばし方式に基づく微細糖質針製造装置による微細糖質針の作製途中状態を示す概略模式図である。  It is a schematic diagram which shows the state in the middle of preparation of the fine sugar needle by the fine sugar needle manufacturing apparatus based on the conventional enlargement system. 本発明の機能剤投与デバイスの製造装置による微細糖質針の作製途中状態を示す概略模式図である。  It is a schematic diagram which shows the state in the middle of preparation of the fine sugar needle | hook by the manufacturing apparatus of the functional agent administration device of this invention. 本発明の機能剤投与デバイスの製造装置による微細糖質針の作製完了状態を示す概略模式図である。  It is a schematic diagram which shows the production completion state of the fine carbohydrate needle | hook by the manufacturing apparatus of the functional agent administration device of this invention.

符号の説明Explanation of symbols

１ 従来の引き伸ばし方式による微細糖質針
２ 基板
３ 多糖類からなる台座
４ 台座上面
５ 台座底面
６ 多糖類からなる基板
７ 略円錐形状の微細糖質針
８ 一体化製造された台座及び基板
９ 分離製造された台座
１０ 分離製造された基板
１１ 釣鐘形状の微細糖質針
１２ 宝珠形状の微細糖質針
１３ 略四角錐形状の微細糖質針
１４ 略釣鐘形状の微細糖質針
１５ 略宝珠形状の微細糖質針
１６ 溶融糖質材供給機の昇降制御機構
１７ 溶融糖質材供給機
１８ ノズル
１９ 溶融糖質材
２０ 基板加熱ヒータ
２１ 基板取付けステージの昇降制御機構
２２ 基板取付けステージ
２３ 糖質加熱容器
２４ 溶融糖質材の引き伸ばし途中の微細糖質針
２５ レーザ光干渉による位置合わせ制御機構
２６ 往復レーザ光
２７ 溶融糖質材の引き伸ばしによる微細糖質針DESCRIPTION OF SYMBOLS 1 Fine sugar needle by conventional stretching method 2 Substrate 3 Pedestal made of polysaccharide 4 Pedestal top surface 5 Pedestal bottom surface 6 Substrate made of polysaccharide 7 Substantially conical fine sugar needle 8 Pedestal and substrate manufactured integrally 9 Separation Produced pedestal 10 Separately manufactured substrate 11 Bell-shaped fine sugar needle 12 Jewel-shaped fine sugar needle 13 Substantially pyramid-shaped fine saccharide needle 14 Substantially bell-shaped fine saccharide needle 15 Substantially jewel-shaped Fine carbohydrate needle 16 Elevation control mechanism 17 of molten sugar material supply machine Molten sugar material supply machine 18 Nozzle 19 Molten sugar material 20 Substrate heater 21 Elevation control mechanism 22 of substrate attachment stage 23 Substrate attachment stage 23 Sugar heating container 24 Fine carbohydrate needle 25 during stretching of molten sugar material 25 Positioning control mechanism 26 by laser beam interference Reciprocating laser beam 27 Fine sugar needle by stretching molten sugar material

Claims (13)

多糖類からなる基板上に、台座高さ１０μｍ〜２ｍｍ、台座上面の直径３０μｍ〜１ｍｍ、該基板と接する台座底面の直径４０μｍ〜１．５ｍｍである略円柱形状の多糖類からなる台座を複数個設け、該台座上に、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、該台座上面と接する針底面の直径３０μｍ〜１ｍｍである略円錐形状又は釣鐘形状の微細糖質針を設けた構造であることを特徴とする機能剤投与デバイス。  A plurality of pedestals made of a substantially cylindrical polysaccharide having a pedestal height of 10 μm to 2 mm, a pedestal top surface diameter of 30 μm to 1 mm, and a pedestal bottom surface diameter of 40 μm to 1.5 mm on the substrate made of polysaccharide. On the pedestal, a fine cone needle having a substantially conical or bell shape with a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, and a needle bottom surface diameter of 30 μm to 1 mm in contact with the pedestal top surface is provided. A functional agent administration device having a provided structure. 多糖類からなる基板上に、台座高さ１０μｍ〜２ｍｍ、台座上面の直径３０μｍ〜１ｍｍ、該基板と接する台座底面の直径４０μｍ〜１．５ｍｍである略円柱形状の多糖類からなる台座を複数個設け、該台座上に、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、該台座上面と接する針底面の直径３０μｍ〜１ｍｍ、針長さ方向における略中間部の最大直径が５０μｍ〜１．５ｍｍである宝珠形状の微細糖質針を設けた構造であることを特徴とする機能剤投与デバイス。  A plurality of pedestals made of a substantially cylindrical polysaccharide having a pedestal height of 10 μm to 2 mm, a pedestal top surface diameter of 30 μm to 1 mm, and a pedestal bottom surface diameter of 40 μm to 1.5 mm on the substrate made of polysaccharide. Provided on the pedestal, the diameter of the needle tip is 0.5 μm to 20 μm, the needle length is 50 μm to 2 mm, the diameter of the needle bottom surface in contact with the pedestal upper surface is 30 μm to 1 mm, and the maximum diameter at the approximate middle in the needle length direction is 50 μm. A functional agent administration device having a structure in which a jewel-shaped fine sugar needle having a diameter of ˜1.5 mm is provided. 多糖類からなる基板上に、台座高さ１０μｍ〜２ｍｍ、台座上面が直径３０μｍ〜１ｍｍの円に内接又は外接し、該基板と接する台座底面が直径４０μｍ〜１．５ｍｍの円に内接又は外接する略多角柱形状の多糖類からなる台座を複数個設け、該台座上に、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、針底面が該台座上面と同一形状である略多角錐形状又は略釣鐘形状の微細糖質針を設けた構造であることを特徴とする機能剤投与デバイス。  On a substrate made of a polysaccharide, a pedestal height of 10 μm to 2 mm, a pedestal top surface is inscribed or circumscribed in a circle having a diameter of 30 μm to 1 mm, and a pedestal bottom surface in contact with the substrate is inscribed in a circle having a diameter of 40 μm to 1.5 mm A plurality of pedestals made of a polysaccharide having a substantially polygonal column shape that is circumscribed are provided. On the pedestal, a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, and a needle bottom surface have the same shape as the top surface of the pedestal. A functional agent administration device having a structure in which a fine sugar needle having a substantially polygonal pyramid shape or a bell shape is provided. 多糖類からなる基板上に、台座高さ１０μｍ〜２ｍｍ、台座上面が直径３０μｍ〜１ｍｍの円に内接又は外接し、該基板と接する台座底面が直径４０μｍ〜１．５ｍｍの円に内接又は外接する略多角柱形状の多糖類からなる台座を複数個設け、該台座上に、針先端の直径０．５μｍ〜２０μｍ、針長さ５０μｍ〜２ｍｍ、針底面が該台座上面と同一形状で、針長さ方向における略中間部が直径５０μｍ〜１．５ｍｍの円に内接又は外接する略多角形である略宝珠形状の微細糖質針を設けた構造であることを特徴とする機能剤投与デバイス。  On a substrate made of a polysaccharide, a pedestal height of 10 μm to 2 mm, a pedestal top surface is inscribed or circumscribed in a circle having a diameter of 30 μm to 1 mm, and a pedestal bottom surface in contact with the substrate is inscribed in a circle having a diameter of 40 μm to 1.5 mm A plurality of pedestals made of a polysaccharide having a substantially polygonal column shape that circumscribes the pedestal, a needle tip diameter of 0.5 μm to 20 μm, a needle length of 50 μm to 2 mm, and a needle bottom surface having the same shape as the top surface of the pedestal, Administration of a functional agent, characterized in that a substantially saccharide-shaped fine saccharide needle having a substantially polygonal shape in which a substantially middle portion in the needle length direction is inscribed or circumscribed in a circle having a diameter of 50 μm to 1.5 mm is provided. device. 該多糖類がプルラン又はカルボキシメチルセルロースであり、該微細糖質針の糖質がマルトースであることを特徴とする請求項１から４いずれか一項記載の機能剤投与デバイス。  The functional agent administration device according to any one of claims 1 to 4, wherein the polysaccharide is pullulan or carboxymethylcellulose, and the sugar of the fine sugar needle is maltose. 該多糖類がプルラン又はカルボキシメチルセルロースであり、該微細糖質針の糖質が主成分をマルトースとし、他成分をグルコース又はトレハロースとする糖質混合物であることを特徴とする請求項１から４いずれか一項記載の機能剤投与デバイス。  5. The polysaccharide according to claim 1, wherein the polysaccharide is pullulan or carboxymethylcellulose, and the sugar of the fine sugar needle is a carbohydrate mixture containing maltose as a main component and glucose or trehalose as another component. The functional agent administration device according to claim 1. 該微細糖質針の糖質に、ビタミンＡ、ビタミンＢ複合体、ビタミンＣ、ビタミンＤ、ビタミンＥ、ビタミンＫ、グルタミン、必須アミノ酸、非必須アミノ酸、γ−アミノ酪酸、タウリン、脂肪酸、核酸、アドレナリン、から選択される１又は２以上の栄養剤を含有させたことを特徴とする請求項５又は６記載の機能剤投与デバイス。  To the carbohydrates of the fine sugar needle, vitamin A, vitamin B complex, vitamin C, vitamin D, vitamin E, vitamin K, glutamine, essential amino acid, non-essential amino acid, γ-aminobutyric acid, taurine, fatty acid, nucleic acid, The functional agent administration device according to claim 5 or 6, further comprising one or more nutrients selected from adrenaline. 該微細糖質針の糖質に、鎮痛薬剤、消炎薬剤、解熱鎮痛消炎薬剤、抗真菌剤、抗菌剤、抗ウィルス薬、強心薬、血栓溶解剤、止血剤、利尿薬、高血圧治療薬、麻酔剤、鎮静剤、睡眠薬、抗痙攣薬、抗不安薬、酔い止め薬、精神安定剤、抗うつ剤、睡眠鎮静剤、抗原虫薬剤、から選択される１の医薬剤を含有させたことを特徴とする請求項５又は６記載の機能剤投与デバイス。  Analyzing drugs, anti-inflammatory drugs, antipyretic analgesic / anti-inflammatory drugs, antifungal drugs, antibacterial drugs, antiviral drugs, cardiotonic drugs, thrombolytic drugs, hemostatic drugs, diuretics, antihypertensive drugs, anesthesia 1 pharmaceutical agent selected from an agent, a sedative, a sleeping pill, an anticonvulsant, an anxiolytic, a sickness-stopper, a tranquilizer, an antidepressant, a sleep sedative, and an antiprotozoal The functional agent administration device according to claim 5 or 6. 該多糖類からなる基板上に、金型成型による該多糖類からなる台座を複数個成形した後、昇降制御機構を有し水平面に沿うステージに、該基板を該台座が鉛直下向き方向を指すように取り付け、該台座上面を静置状態の９０℃〜１２０℃に温度制御された糖質加熱容器内の溶融した該糖質の上面に接触させた後、該ステージを昇降させることにより該台座上面に該微細糖質針を成形することを特徴とする請求項１から８いずれか一項記載の機能剤投与デバイスの製造方法。  After forming a plurality of pedestals made of the polysaccharide by mold molding on the substrate made of the polysaccharide, the pedestal is placed on a stage along a horizontal plane having an elevation control mechanism so that the pedestal points in a vertically downward direction. The pedestal upper surface is brought into contact with the upper surface of the molten saccharide in the saccharide heating container whose temperature is controlled at 90 ° C. to 120 ° C. in a stationary state, and then the stage is moved up and down to raise the pedestal upper surface. The method for producing a functional agent administration device according to any one of claims 1 to 8, wherein the fine saccharide needle is molded into the same. 該多糖類からなる基板上に、金型成型による該多糖類からなる台座を複数個成形した後、昇降制御機構を有し水平面に沿うステージに、該基板を該台座が鉛直下向き方向を指すように取り付け、該台座上面を静置状態の９０℃〜１２０℃に温度制御された糖質加熱容器内の溶融した該糖質の上面に接触させた後、該ステージを昇降させることにより該台座上面に該微細糖質針を成形することを特徴とする機能剤投与デバイスの製造方法による請求項１から８いずれか一項記載の機能剤投与デバイス。  After forming a plurality of pedestals made of the polysaccharide by mold molding on the substrate made of the polysaccharide, the pedestal is placed on a stage along a horizontal plane having an elevation control mechanism so that the pedestal points in a vertically downward direction. The pedestal upper surface is brought into contact with the upper surface of the molten saccharide in the saccharide heating container whose temperature is controlled at 90 ° C. to 120 ° C. in a stationary state, and then the stage is moved up and down to raise the pedestal upper surface. The functional agent administration device according to any one of claims 1 to 8, wherein the fine agent needle is molded into a functional agent administration device manufacturing method. 該ステージの昇降移動距離をデジタル式に微小に区切り、該昇降移動距離を任意に変更して該ステージ昇降の移動速度を微調整する制御方法により、該台座上面に該微細糖質針を高精度に成形することを特徴とする請求項９記載の機能剤投与デバイスの製造方法。  The fine sugar needle is placed on the upper surface of the pedestal with a high accuracy by a control method that finely divides the vertical movement distance of the stage into a digital type and finely adjusts the vertical movement speed by arbitrarily changing the vertical movement distance. The method for producing a functional agent administration device according to claim 9, wherein the functional agent administration device is formed into a shape. 請求項９記載の機能剤投与デバイスの製造方法において、該ステージの昇降移動距離をデジタル式に微小に区切り、該昇降移動距離を任意に変更して該ステージ昇降の移動速度を微調整する制御方法により、該台座上面に該微細糖質針を高精度に成形することを特徴とする機能剤投与デバイスの製造方法による請求項１から８いずれか一項記載の機能剤投与デバイス。  10. The method of manufacturing a functional agent administration device according to claim 9, wherein the vertical movement distance of the stage is finely divided digitally, and the vertical movement speed is finely adjusted by arbitrarily changing the vertical movement distance. The functional agent administration device according to claim 1, wherein the fine sugar needle is formed with high accuracy on the upper surface of the pedestal by the method for producing a functional agent administration device. 該機能剤投与デバイスの製造装置において、９０℃〜１２０℃の温度制御機構を有する糖質加熱容器、及び該基板を該台座が鉛直下向き方向を指すように取付けることが可能な昇降制御機構を有する水平面に沿うステージであり、更に該台座上面と溶融した該糖質の上面との距離を任意に位置決めする位置合わせ制御機構を有する該ステージ、から構成されることを特徴とする請求項１から８いずれか一項記載の機能剤投与デバイスの製造装置。  The apparatus for manufacturing a functional agent administration device includes a sugar heating container having a temperature control mechanism of 90 ° C. to 120 ° C., and a lift control mechanism capable of attaching the substrate so that the pedestal points in a vertically downward direction. 9. The stage along a horizontal plane, and further comprising the stage having an alignment control mechanism for arbitrarily positioning a distance between the upper surface of the base and the upper surface of the molten carbohydrate. An apparatus for manufacturing a functional agent administration device according to any one of the above.

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