JP2009273772A - Microneedle sheet, and method and device for manufacturing the same - Google Patents
Microneedle sheet, and method and device for manufacturing the same Download PDFInfo
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- JP2009273772A JP2009273772A JP2008129820A JP2008129820A JP2009273772A JP 2009273772 A JP2009273772 A JP 2009273772A JP 2008129820 A JP2008129820 A JP 2008129820A JP 2008129820 A JP2008129820 A JP 2008129820A JP 2009273772 A JP2009273772 A JP 2009273772A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
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Abstract
Description
本発明は、シート部の裏面に、複数の円錐形状又は角錐形状のマイクロニードルが形成された医薬品用途並びに化粧品用途のマイクロニードルシート並びにその製造方法及び製造装置に関するものである。特に皮膚表層及び皮膚角質層において、簡便に、安全かつ効率的に薬剤などを注入することが可能なものである。 The present invention relates to a microneedle sheet for use in pharmaceuticals and cosmetics in which a plurality of conical or pyramidal microneedles are formed on the back surface of a sheet portion, a manufacturing method and a manufacturing apparatus therefor. Particularly, in the skin surface layer and the skin stratum corneum, it is possible to inject drugs and the like simply, safely and efficiently.
従来、経皮的に薬剤等を投与する方法として、生体内溶解性を有する高分子物質を基剤として目的とする機能性物質を内包又は含有したマイクロパイルを、皮膚に突き刺し挿入して基剤が自己溶解することによって目的とする機能性物質を皮膚内に投与する機能性マイクロパイル及びその製造方法が特許文献１に開示されている。 Conventionally, as a method for transdermally administering a drug or the like, a base is prepared by inserting a micropile containing or containing a target functional substance into a skin with a polymer substance having in vivo solubility as a base, and inserting it into the skin. Patent Document 1 discloses a functional micropile in which a target functional substance is administered into the skin by self-dissolving and a manufacturing method thereof.
また、特許文献１にはスタンパー（成形型）に樹脂ポリマーを溶解させた溶液を塗布し、乾燥し、スタンパーから剥離することにより、樹脂ポリマー凝固体であるマイクロニードルシートの製造方法及び製造装置が開示されている。
しかしながら、特許文献１に開示された発明では、塗布工程で微小針部と樹脂ポリマー部とを同時に塗布して一体的に成型するため、樹脂ポリマー部にも目的とする機能性材料が含まれることになる。機能性材料は微小針部の皮膚へ突き刺し挿入する部分にだけに含まれていればよく樹脂ポリマー部にも含まれる機能性材料は全く無駄となっていた。特に高価なインスリンなどの機能性材料の場合には高コストになってしまうといった問題点があった。 However, in the invention disclosed in Patent Document 1, since the microneedle part and the resin polymer part are simultaneously applied and integrally molded in the application process, the resin material part also contains the intended functional material. become. The functional material only needs to be included in the portion of the microneedle portion that is pierced and inserted into the skin, and the functional material included in the resin polymer portion is completely useless. In particular, in the case of expensive functional materials such as insulin, there is a problem that the cost becomes high.
他に、製造時の乾燥工程においては微小針と樹脂ポリマー部とを乾燥して凝固させる必要があるが、樹脂ポリマー部の体積が大きいため乾燥時間が長くかかって、生産性に乏しく高コストになってしまうといった問題点があった。 In addition, in the drying process at the time of manufacture, it is necessary to dry and solidify the microneedles and the resin polymer part, but since the volume of the resin polymer part is large, the drying time is long, resulting in poor productivity and high cost. There was a problem of becoming.
請求項１に記載の発明は、シート部の裏面に、複数の円錐形状又は角錐形状のマイクロニードルが形成された医薬品用途並びに化粧品用途のマイクロニードルシートにおいて、前記シート部が水溶性樹脂フィルムからなることを特徴とする医薬品用途並びに化粧品用途のマイクロニードルシートである。 The invention according to claim 1 is a microneedle sheet for pharmaceutical use and cosmetic use in which a plurality of conical or pyramidal microneedles are formed on the back surface of the sheet part, and the sheet part is made of a water-soluble resin film. This is a microneedle sheet for pharmaceutical use and cosmetic use.
請求項２に記載の発明は、シート部の裏面に、複数の円錐形状又は角錐形状のマイクロニードルが形成された医薬品用途並びに化粧品用途のマイクロニードルシートにおいて、前記水溶性樹脂フィルムからなるシート部と、水溶性高分子物質からなるマイクロニードル部と、水溶性樹脂シートに接着した支持体シート部とからなることを特徴とする医薬品用途並びに化粧品用途のマイクロニードルシートである。 The invention according to claim 2 is a microneedle sheet for pharmaceutical use and cosmetic use in which a plurality of conical or pyramidal microneedles are formed on the back surface of the sheet part, the sheet part comprising the water-soluble resin film, A microneedle sheet for pharmaceutical use and cosmetic use, characterized by comprising a microneedle part made of a water-soluble polymer substance and a support sheet part bonded to the water-soluble resin sheet.
請求項３に記載の発明は、前記水溶性樹脂フィルムが多糖類から成ることを特徴とする請求項１及び請求項２に記載のマイクロニードルシートである。 The invention according to claim 3 is the microneedle sheet according to claim 1 or 2, wherein the water-soluble resin film is made of a polysaccharide.
請求項４に記載の発明は、前記水溶性高分子物質から成るマイクロニードルが、生体内溶解性又は生体内分解性の高分子物質と、目的とする機能性物質とから成ることを特徴とする請求項１及び請求項２に記載のマイクロニードルシートである。 The invention according to claim 4 is characterized in that the microneedle comprising the water-soluble polymer substance comprises a polymer substance that is soluble or biodegradable in a living body and a target functional substance. A microneedle sheet according to claim 1 and claim 2.
請求項５に記載の発明は、前記マイクロニードルの基底から先端までの長さが１００〜１０００μｍで、マイクロニードルの長さと根元径又は根元対角長とのアスペクト比が１．５〜３．５であることを特徴とする請求項１、請求項２及び請求項４に記載のマイクロニードルシートである。 In the invention according to claim 5, the length from the base to the tip of the microneedle is 100 to 1000 μm, and the aspect ratio of the length of the microneedle to the root diameter or the root diagonal length is 1.5 to 3.5. The microneedle sheet according to claim 1, 2, or 4, wherein the microneedle sheet is a microneedle sheet.
請求項６に記載の発明は、前記マイクロニードルの側面に凹部を設けたことを特徴とする請求項１から請求項５に記載のマイクロニードルシートである。 A sixth aspect of the present invention is the microneedle sheet according to any one of the first to fifth aspects, wherein a concave portion is provided on a side surface of the microneedle.
請求項７に記載の発明は、前記支持体シートは柔軟性があり、その片面に接着剤を有する事を特徴とする請求項１から請求項６に記載のマイクロニードルシート。 The invention according to claim 7 is the microneedle sheet according to any one of claims 1 to 6, wherein the support sheet is flexible and has an adhesive on one side thereof.
請求項８に記載の発明は、前記マイクロニードルシートの製造方法において、マイクロニードルを成形するための成形型に設けた複数の逆円錐又は逆角錐形状の細孔に、前記水溶性高分子物質の水溶液を滴下充填する工程と、滴下充填された水溶性高分子物質の水溶液に水溶性樹脂フィルムを圧接溶着する工程と、乾燥する工程と、乾燥することにより固化一体化して形成されるマイクロニードルシートのシート部に、表面に粘着剤が塗布された支持体シートを接着する工程と、マイクロニードルシートを成形型より剥離する工程と、により製造されるマイクロニードルシートの製造方法である。 According to an eighth aspect of the present invention, in the method of manufacturing a microneedle sheet, the water-soluble polymer substance is formed in a plurality of inverted cone or inverted pyramid-shaped pores provided in a mold for molding the microneedle. A microneedle sheet formed by solidifying and integrating by a step of dropping and filling an aqueous solution, a step of pressure-welding a water-soluble resin film to the aqueous solution of the water-soluble polymer substance dropped and filled, a step of drying, and a drying It is the manufacturing method of the microneedle sheet | seat manufactured by the process of adhere | attaching the support sheet | seat with which the adhesive was apply | coated to the sheet | seat part, and the process of peeling a microneedle sheet | seat from a shaping | molding die.
請求項９に記載の発明は、前記乾燥する工程が、成形型を減圧環境下で且つ回転による遠心力によって加圧することを特徴とする請求項８に記載のマイクロニードルシートの製造方法である。 The invention according to claim 9 is the method for producing a microneedle sheet according to claim 8, wherein the drying step pressurizes the mold in a reduced pressure environment by a centrifugal force by rotation.
請求項１０に記載の発明は、前記マイクロニードルシートの製造装置において、マイクロニードルを成形するための成形型に設けた複数の逆円錐又は逆角錐形状の細孔に、水溶性高分子物質の水溶液を滴下充填する滴下充填部と、滴下充填された水溶性高分子物質の水溶液に水溶性樹脂フィルムを被せて圧接溶着する圧接溶着工程と、空気流により乾燥する乾燥部と、乾燥することにより固化一体化して形成されるマイクロニードルシートのシート部の表面に、粘着剤が塗布された支持体シートを接着する接着部と、マイクロニードルシートを成形型より剥離する剥離部と、により製造されるマイクロニードルシートの製造装置である。 The invention according to claim 10 is an apparatus for producing a microneedle sheet, wherein an aqueous solution of a water-soluble polymer substance is provided in a plurality of inverted cone or inverted pyramid-shaped pores provided in a mold for molding the microneedle. Solidified by drying, a dropping filling part for dropping and filling, a pressure welding process for pressure welding by applying a water-soluble resin film to an aqueous solution of the water-soluble polymer substance dropped and filled, a drying part for drying by air flow A micro manufactured by an adhesive part that adheres a support sheet coated with an adhesive to a surface of a sheet part of a microneedle sheet that is integrally formed, and a peeling part that peels the microneedle sheet from a mold. This is a needle seat manufacturing apparatus.
以上により、本発明によるマイクロニードルシートは、マイクロニードル部にのみ機能性材料を含有させることができ特に高価な機能性材料の無駄が無くなるという効果がある。 As described above, the microneedle sheet according to the present invention has an effect that the functional material can be contained only in the microneedle portion, and particularly the expensive functional material is not wasted.
また、シート部が水溶性樹脂フィルムで形成されているため製造時の乾燥時間を大幅に短縮でき製造コストを低くできる効果がある。 Further, since the sheet portion is formed of a water-soluble resin film, there is an effect that the drying time at the time of manufacture can be greatly shortened and the manufacturing cost can be reduced.
他に、シート部が柔軟性に富んだ薄い水溶性樹脂フィルムであるため、貼付時、皮膚面の凹凸に倣い易くマイクロニードルの突き刺し挿入が確実となる。また、マイクロニードル部の側面に凹部を設けたため突き刺し挿入後くさび効果により皮膚面から剥がれ難く、目的とする機能性物質の投与が確実に行なわれる効果がある。 In addition, since the sheet portion is a thin water-soluble resin film rich in flexibility, it is easy to follow the unevenness of the skin surface when sticking, and the insertion of the microneedle is ensured. Further, since the concave portion is provided on the side surface of the microneedle portion, it is difficult to peel off from the skin surface due to the wedge effect after insertion and insertion, and there is an effect that the intended functional substance can be reliably administered.
以下、本発明の実施形態について図１を参照しながら具体的に説明する。
本実施形態のマイクロニードルシート１は、シート部３の裏面に複数の円錐形状又は角錐形状のマイクロニードル２が形成され、前記水溶性樹脂フィルムからなるシート部３と、水溶性高分子物質からなるマイクロニードル部２と、水溶性樹脂シートに接着した支持体シート部４からなる医薬品用途並びに化粧品用途のマイクロニードルシート１である。
Hereinafter, an embodiment of the present invention will be specifically described with reference to FIG.
The microneedle sheet 1 of the present embodiment has a plurality of conical or pyramidal microneedles 2 formed on the back surface of the sheet portion 3, and is composed of the sheet portion 3 made of the water-soluble resin film and a water-soluble polymer substance. This is a microneedle sheet 1 for pharmaceutical use and cosmetic use comprising a microneedle part 2 and a support sheet part 4 bonded to a water-soluble resin sheet.
水溶性高分子物質からなるマイクロニードル２に適用可能な生体内溶解性の高分子物質として、例えば多糖類、ポリビニルアルコールが挙げられる。 Examples of in vivo soluble polymer materials applicable to the microneedles 2 made of a water-soluble polymer material include polysaccharides and polyvinyl alcohol.
水溶性高分子物質からなるマイクロニードル２適用可能な生体内分解性の高分子物質として、例えばポリアクリル酸ナトリウムが挙げられる。 An example of a biodegradable polymer substance that can be applied to the microneedle 2 made of a water-soluble polymer substance is sodium polyacrylate.
マイクロニードル２に適用可能な医薬用の機能性物質として、例えばエリスロポエチン、インスリン、ヘパリン、及びビタミンなどが挙げられる。 Examples of pharmaceutical functional substances applicable to the microneedle 2 include erythropoietin, insulin, heparin, and vitamins.
マイクロニードル２に適用可能な化粧用の機能性物質として、例えばヒアルロンサン及びコラーゲンなどが挙げられる。 Examples of functional functional substances applicable to the microneedles 2 include hyaluronic sun and collagen.
前記物質を少なくとも一つ以上混合溶解した水溶性高分子物質の水溶液を成形型内に滴下充填し乾燥固化しマイクロニードル２を成形する。 An aqueous solution of a water-soluble polymer substance in which at least one substance is mixed and dissolved is dropped into the mold and dried and solidified to form the microneedle 2.
これにより、例えばマイクロニードルを突き刺し挿入した際、折損して患者の体内に残存した場合であっても生体内で溶解又は分解され、生体へのリスクが軽減されることが期待できる。 Thereby, for example, when a microneedle is pierced and inserted, it can be expected to be dissolved or decomposed in the living body even if it breaks and remains in the patient's body, thereby reducing the risk to the living body.
前記シート部３は水溶性樹脂フィルムからなり、マイクロニードル２の基底部に溶着後、乾燥固化してマイクロニードルシート１を形成する。 The sheet portion 3 is made of a water-soluble resin film, and is welded to the base portion of the microneedle 2 and then dried and solidified to form the microneedle sheet 1.
シート部３に適用可能な水溶性樹脂フィルムとして、例えば多糖類のフィルムが挙げられる。林原製の商品名プルランなどが好適である。 Examples of the water-soluble resin film applicable to the sheet portion 3 include a polysaccharide film. The product name Pullulan manufactured by Hayashibara is suitable.
シート部３は柔軟性に富むため皮膚面の凹凸に倣い易く良好に密着するのでマイクロニードル２が確実に均等に突き刺ささり挿入できる。 Since the sheet part 3 is rich in flexibility, it easily follows the unevenness of the skin surface and adheres well, so that the microneedles 2 can be inserted evenly and reliably.
前記マイクロニードル２は、その基底部から先端までの長さ寸法が略１００〜１０００μｍで、長さと円錐形状の根元径又は多角錐形状の根元対角長さとのアスペクト比が略１．５〜３．５に設定され先端が鋭く尖っているので、皮膚面へ確実に突き刺し易い形状となっている。 The microneedle 2 has a length dimension from the base to the tip of approximately 100 to 1000 μm, and an aspect ratio of approximately 1.5 to 3 of the length and the cone-shaped root diameter or the polygonal pyramid-shaped root diagonal length. Since the tip is sharp and sharp, it has a shape that is surely easy to pierce the skin surface.
マイクロニードル２は、必要に応じて、図５に示す通り、円錐形状又は多角錐形状の側面の任意の部位の円周方向に少なくとも一つの凹部例えば断面Ｖ字形状の溝を設けているので、皮膚面へ突き刺した後容易に抜け難い形状とすることができる。 Since the microneedle 2 is provided with at least one concave portion, for example, a groove having a V-shaped cross section in the circumferential direction of an arbitrary portion of the side surface of the cone shape or the polygonal pyramid shape as shown in FIG. It can be made into a shape that is not easily removed after piercing the skin surface.
前記支持体シート４はその片面に接着剤を有する柔軟性のあるシート状材料ある。適用可能な材料として紙、樹脂フィルム、サージカルテープなどが挙げられる。 The support sheet 4 is a flexible sheet-like material having an adhesive on one side. Applicable materials include paper, resin film, and surgical tape.
支持体シート４は、その接着剤でシート部３の表面に接着するとともに、支持体シート４を用いてマイクロニードルシート１を成形型９から剥離する。支持体シート４の接着剤はマイクロニードルシート１を皮膚面へ接着し固定するために用いられる。 The support sheet 4 is adhered to the surface of the sheet portion 3 with the adhesive, and the microneedle sheet 1 is peeled from the mold 9 using the support sheet 4. The adhesive of the support sheet 4 is used to adhere and fix the microneedle sheet 1 to the skin surface.
次に、前記のマイクロニードルシート１の製造方法及び製造装置について説明する。
図２は本実施の形態のフローチャートであり、図3は製造のために用いられる製造装置の一例である。
Next, the manufacturing method and manufacturing apparatus of the microneedle sheet 1 will be described.
FIG. 2 is a flowchart of the present embodiment, and FIG. 3 is an example of a manufacturing apparatus used for manufacturing.
最初に、図２に示すステップＳ１０１の原版作成工程を行なう。具体的には、マイクロニードルシート１を製造のための成形型９の原版６を作成する工程を図４（ａ）に示す。 First, the original plate creating process of step S101 shown in FIG. 2 is performed. Specifically, FIG. 4A shows a process of creating the original plate 6 of the mold 9 for manufacturing the microneedle sheet 1.
この原版６はマイクロニードル原版７と、マイクロニードル原版支持部８とから成り、それぞれ公知の機械加工法を用いて作成する。 This original plate 6 is composed of a microneedle original plate 7 and a microneedle original plate support portion 8, and each is prepared using a known machining method.
マイクロニードル原版７は細い金属丸棒、例えばステンレス鋼を旋盤による切削加工で端部を円錐形状に切削して作成する。これら複数のマイクロニードル原版７を作成して用意する。 The microneedle original plate 7 is formed by cutting a thin metal round bar, for example, stainless steel into a conical shape by cutting with a lathe. A plurality of microneedle masters 7 are prepared and prepared.
マイクロニードル原版支持部８は金属板、例えばアルミ板にマイクロニードル原版７と略等しい径の孔を複数開け、そこにマイクロニードル原版７を挿入位置決めしてから接着剤で固定する。この方法によれば、原版６を安価に効率よく製造することができる。 The microneedle original plate support portion 8 is formed with a plurality of holes having a diameter substantially equal to that of the microneedle original plate 7 on a metal plate, for example, an aluminum plate, and the microneedle original plate 7 is inserted and positioned therein and then fixed with an adhesive. According to this method, the original plate 6 can be efficiently manufactured at low cost.
他に金属板、例えばステンレス鋼板から公知の機械切削加工で複数の角錐形状のマイクロニードルを有する原版を一体的に削りだして作成することもできる。 In addition, an original plate having a plurality of pyramidal microneedles can be integrally cut out from a metal plate, for example, a stainless steel plate, by a known mechanical cutting process.
前記マイクロニードル原版７は、必要に応じてマイクロニードル原版７の側面の任意の位置に任意の形状の溝、例えば図５に示す断面Ｖ字形状の溝を加工することができる。 The microneedle original plate 7 can be processed into a groove having an arbitrary shape, for example, a V-shaped groove shown in FIG. 5, at an arbitrary position on the side surface of the microneedle original plate 7 as required.
次に、図２に示すステップＳ１０２の成形型作成工程を行なう。原版６に、シリコーン樹脂に硬化剤を添加撹拌して流し込み図４（ｂ）、硬化した後原版６より剥離して成形型９を得る。成形型９の内部に気泡が残存すると空洞の欠陥を生じるので、シリコーン樹脂に硬化剤を添加撹拌後、及び成形型９に流し込み後、減圧環境下で脱泡することが望ましい。 Next, a forming mold creating process of step S102 shown in FIG. 2 is performed. A curing agent is added to the original plate 6 with stirring and poured into a silicone resin. FIG. 4 (b) is cured and peeled from the original plate 6 to obtain a mold 9. If bubbles remain inside the mold 9, void defects are generated. Therefore, it is desirable to defoam in a reduced pressure environment after adding and stirring the curing agent to the silicone resin and pouring into the mold 9.
このようにして製作された成形型９を図４（ｃ）に示す。この方法によれば、成形型９には原版６の形状が正確に転写されると共に、成形型９は何度でも容易に、安価に製造することができる。 The mold 9 produced in this way is shown in FIG. According to this method, the shape of the original 6 is accurately transferred to the mold 9 and the mold 9 can be easily and inexpensively manufactured any number of times.
次に、図２に示すステップＳ１０３の水溶性高分子物質の水溶液５の滴下充填工程を行なう。具体的には成形型作成工程により製作された成形型９のマイクロニードル原版７に対応した逆円錐形状の細孔に略同じ体積の水溶性高分子物質の水溶液５を分注機例えば武蔵エンジニアリング製を用いて滴下充填する。滴下充填後の成形型９の状態を図４（ｄ）に示す。上記方法によれば、水溶性高分子物質の水溶液５は逆円錐形状の細孔部のみに充填できるので材料の無駄が無く安価に製造することができる。 Next, the dropping filling step of the aqueous solution 5 of the water-soluble polymer substance in step S103 shown in FIG. 2 is performed. Specifically, an aqueous solution 5 of a water-soluble polymer substance having substantially the same volume is poured into an inverted conical pore corresponding to the microneedle master plate 7 of the mold 9 produced by the mold making process, for example, manufactured by Musashi Engineering. And drop-fill using. FIG. 4 (d) shows the state of the mold 9 after dropping and filling. According to the above method, since the aqueous solution 5 of the water-soluble polymer substance can be filled only in the inverted conical pores, the material is not wasted and can be manufactured at low cost.
次に、図２に示すステップＳ１０４の水溶性樹脂フィルムの溶着工程を行なう。具体的には成形型９の逆円錐形状の細孔に滴下充填した水溶性高分子物質の水溶液５の面上に水溶性樹脂フィルムを被せ軽く圧接する。水溶性樹脂フィルムは水溶性高分子物質の水溶液５の水分を吸収し溶解する。水溶性樹脂フィルム溶着後の成形型９の状態を図４（ｅ）に示す。 Next, the welding process of the water-soluble resin film in step S104 shown in FIG. 2 is performed. Specifically, a water-soluble resin film is placed on the surface of the aqueous solution 5 of the water-soluble polymer substance dropped and filled into the inverted conical pores of the mold 9 and lightly pressed. The water-soluble resin film absorbs and dissolves water in the aqueous solution 5 of the water-soluble polymer substance. The state of the mold 9 after the water-soluble resin film is welded is shown in FIG.
次に、図２に示すステップＳ１０５の水溶性高分子物質の水溶液５の圧入乾燥工程を行なう。具体的には、成形型９の水溶性高分子物質の水溶液５に溶着した水溶性樹脂フィルムの上面に空気を吹きつけることにより乾燥させる。温風を吹き付けることで乾燥効果を更に高める事ができる。乾燥工程の成形型９の状態を図４（ｆ）に示す。 Next, the press-in drying process of the aqueous solution 5 of the water-soluble polymer substance in step S105 shown in FIG. 2 is performed. Specifically, it is dried by blowing air onto the upper surface of the water-soluble resin film welded to the aqueous solution 5 of the water-soluble polymer substance of the mold 9. The drying effect can be further enhanced by blowing warm air. The state of the mold 9 in the drying process is shown in FIG.
前記乾燥工程中に、水溶性高分子物質の水溶液５の圧入工程を行なうことが望ましい。前記水溶性高分子物質の水溶液５の滴下充填工程において成形型９の逆円錐形の細孔部に水溶性高分子物質の水溶液５が奥まで入り込まず気泡が残ることがあるので、 成形型を減圧環境下で公知の遠心分離機などの回転ドラムにセットして回転による遠心力を加えて圧入することが望ましい。これによりマイクロニードル２に気泡による欠陥が生じることを防ぐ事ができる。 It is desirable to perform a press-fitting step of the aqueous solution 5 of the water-soluble polymer substance during the drying step. In the step of dropping and filling the aqueous solution 5 of the water-soluble polymer substance, the aqueous solution 5 of the water-soluble polymer substance may not enter the interior of the inverted conical pores of the mold 9 and bubbles may remain. It is desirable to set in a rotary drum such as a known centrifuge in a reduced pressure environment and apply pressure by applying centrifugal force by rotation. Thereby, it is possible to prevent the microneedle 2 from being defective due to bubbles.
前記回転によれば、回転による空気流のみで乾燥させることができるので乾燥ファンを省略することができる。また加圧と乾燥を同じ工程で行なうことにより乾燥時間を更に短縮することができる。 According to the rotation, the drying fan can be omitted because it can be dried only by the air flow by the rotation. Moreover, drying time can be further shortened by performing pressurization and drying in the same process.
乾燥の結果、成形型の水溶性高分子物質の水溶液５と水溶性フィルムは乾燥固化し、一体化したマイクロニードルシート１を得ることができる。 As a result of drying, the water-soluble polymer aqueous solution 5 and the water-soluble film of the mold are dried and solidified to obtain an integrated microneedle sheet 1.
次に、図２に示すステップＳ１０７の支持体シート４の接着剥離工程を行なう。具体的には、前記乾燥工程において成形型９上で乾燥固化したマイクロニードルシート１の表面に、粘着層が形成された支持体シート４を接着させた後、端部からめくるようにして剥離する。支持体シート４の接着後の成形型９の状態を図４（ｇ）に示す。また成形型９から剥離後の剥離後マイクロニードルシート１を図４（ｈ）に示す。 Next, the adhesion peeling process of the support body sheet | seat 4 of step S107 shown in FIG. 2 is performed. Specifically, the support sheet 4 on which the adhesive layer is formed is adhered to the surface of the microneedle sheet 1 dried and solidified on the mold 9 in the drying step, and then peeled off so as to be turned from the end. . The state of the mold 9 after the support sheet 4 is bonded is shown in FIG. Moreover, the microneedle sheet 1 after peeling after peeling from the shaping | molding die 9 is shown in FIG.4 (h).
前記剥離工程では微小のマイクロニードルが破壊する事が多々あったが、シリコーン材料で製作された成形型は非常に剥離しやすく、また弾性に富んだ柔らかい材料であるため剥離する際マイクロニードル２にかかる応力を緩和する事ができ成形の歩留まりを向上させることができる。 In the exfoliation process, micro microneedles were often destroyed, but the mold made of silicone material is very easy to exfoliate, and is a soft material rich in elasticity. Such stress can be relaxed and the yield of molding can be improved.
１ マイクロニードルシート
２ マイクロニードル
３ シート部（水溶性樹脂フィルム）
４ 支持体シート
５ 水溶性高分子物質の水溶液
６ 原版
７ マイクロニードル原版
８ マイクロニードル原版支持部
９ 成形型
1 Microneedle sheet 2 Microneedle 3 Sheet part (water-soluble resin film)
4 Support Sheet 5 Aqueous Solution of Water-soluble Polymer Substance 6 Original Plate 7 Microneedle Master Plate 8 Microneedle Master Support Section 9 Mold
Claims (10)
で、マイクロニードルの長さと根元径又は根元対角長とのアスペクト比が１．５〜３．５であることを特徴とする請求項１、から請求項４に記載のマイクロニードルシート。 The length from the base to the tip of the microneedle is 100 to 1000 μm
The microneedle sheet according to any one of claims 1 to 4, wherein the aspect ratio between the length of the microneedle and the root diameter or the root diagonal length is 1.5 to 3.5.
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| JP2008129820A JP2009273772A (en) | 2008-05-16 | 2008-05-16 | Microneedle sheet, and method and device for manufacturing the same |
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| JP2008129820A JP2009273772A (en) | 2008-05-16 | 2008-05-16 | Microneedle sheet, and method and device for manufacturing the same |
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