WO2007123131A1 - Iontophoresis system - Google Patents

Iontophoresis system Download PDF

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Publication number
WO2007123131A1
WO2007123131A1 PCT/JP2007/058362 JP2007058362W WO2007123131A1 WO 2007123131 A1 WO2007123131 A1 WO 2007123131A1 JP 2007058362 W JP2007058362 W JP 2007058362W WO 2007123131 A1 WO2007123131 A1 WO 2007123131A1
Authority
WO
WIPO (PCT)
Prior art keywords
working
drug
ion
electrode structure
viscous liquid
Prior art date
Application number
PCT/JP2007/058362
Other languages
French (fr)
Japanese (ja)
Inventor
Yuriko Watanabe
Mitsugu Yamauchi
Original Assignee
Tti Ellebeau, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tti Ellebeau, Inc. filed Critical Tti Ellebeau, Inc.
Priority to JP2008512122A priority Critical patent/JPWO2007123131A1/en
Publication of WO2007123131A1 publication Critical patent/WO2007123131A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0428Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
    • A61N1/0444Membrane

Definitions

  • the present invention relates to an iontophoresis system including an iontophoresis device for administering drug ions to a living body by applying a voltage, and in particular, the skin of the living body and the iontophoresis device.
  • the present invention relates to an iontophoresis system that can easily improve the adhesion of an ion-selective membrane and deliver drug ions evenly.
  • a working electrode structure As an iontophoresis device for administering drug ions to a living body by applying a voltage, as described in WO03037425 (Patent Document 1), a working electrode structure and a non-action Some have side electrode structures that allow medicinal ions to be administered to the skin and mucous membranes from the ion exchange membrane of the working electrode structure.
  • the working electrode structure in the iontophoresis device described in Patent Document 1 includes, from the contact side with the skin or mucous membrane, an ion exchange membrane, a chemical solution holding unit, an ion exchange membrane, an electrolyte holding unit, The working side electrodes are stacked in this order.
  • the non-working side electrode structure is formed by laminating an ion exchange membrane, an electrolytic solution holding unit, an ion exchange membrane, an electrolytic solution holding unit, and a non-working side electrode in this order from the contact side with the skin or mucous membrane. Configured.
  • the present invention can easily deliver drug ions to the skin by simply interposing a contact liquid, eliminating the gap between the ion-selective membrane such as an ion exchange membrane and the skin and improving adhesion.
  • the problem to be solved is to provide technologies that can be used.
  • the present invention comprises a DC power supply, a working electrode structure connected to one of an anode and a cathode of the DC power supply, and a non-working electrode structure connected to the other, and the working electrode
  • An iontophoresis device for administering a drug ion held in a structure to a living body by a voltage from the DC power source, wherein the working electrode structure has the same kind of polarity as the drug ion.
  • a working electrode connected to an anode or a cathode; a drug solution holding unit electrically connected to the working side electrode for holding a drug to be the drug ion; and electrically connected to the drug solution holding unit;
  • An iontophoresis device having at least a working ion selective membrane that selectively allows the same kind of ions as drug ions to pass through, and a living body side of the working ion selective membrane of the iontophoresis device
  • the order to cover characterized by comprising a release liner viscous liquid holding portion is provided, the Onto Foret over cis system ⁇ Koyori is obtained by solving the above problems.
  • the present invention is also composed of a DC power source, a working side electrode structure connected to one of an anode and a cathode of the DC power source and a non-working side electrode structure connected to the other, An iontophoresis device for administering drug ions held in a working electrode structure to a living body by a voltage from the DC power source, wherein the non-working electrode structure is opposite to the drug ions.
  • a non-working-side electrode connected to the anode or cathode, an electrolyte-holding unit electrically connected to the working-side electrode and holding the electrolyte, and an electrical connection with the electrolyte-holding unit
  • An iontophoresis device having at least a non-working side ion selective membrane connected and selectively allowing ions opposite to the drug ions to pass therethrough, and non-working side ion selection of the iontophoresis device
  • the biological side of the membrane For bars, and release liner viscous liquid holding portion is provided by I O cement Foret over cis system comprising the one in which the above-mentioned problems are eliminated.
  • the viscous liquid holding portion may include a continuous foamed body such as a sponge disposed in a recess of the release liner.
  • the viscous liquid may be a mixture of water and a water-soluble polymer.
  • the viscous liquid may include the same drug as the drug in the drug holding unit or the same electrolytic solution as the electrolytic solution in the electrolytic solution holding unit.
  • the viscous liquid is retained using the release liner having the viscous liquid retaining portion, so that the viscous liquid can be easily attached to the ion selective membrane. It improves the adhesion between the selective membrane and the skin and allows sufficient delivery of drug ions to the skin.
  • FIG. 1 is an exploded perspective view showing an iontophoresis system according to an embodiment of the present invention.
  • FIG. 2 is a working side electrode and a non-working side in an iontophoresis device of the iontophoresis system. Plan view showing enlarged electrode part
  • FIG.5 Sectional view showing the assembled state of the iontophoresis system
  • FIG. 6 Cross-sectional view showing the state of wearing the release liner of the iontophoresis system
  • FIG. 7 Cross-sectional view showing the wearing state of the iontophoresis device on the skin
  • An iontophoresis device 10 constituting the iontophoresis system is connected to a DC power source 12, a working electrode structure 20 connected to one of an anode and a cathode of the DC power source 12, and the other.
  • the non-working side electrode structure 40 is configured to administer drug ions held in the working side electrode structure 20 to the living body by the voltage from the DC power source 12.
  • the working electrode structure 20 and the non-working electrode structure 40 are formed by superposing constituent members such as a chemical solution holding unit, and each of them is a base that also has a resin sheet force. It is configured to be sandwiched between the end support 14 and the intermediate support 16 or housed in a through hole formed in the intermediate support 16 and the tip support 18.
  • the proximal support 14 and the intermediate support 16 are the same size, and the distal support 18 is formed larger than these. It is.
  • the base end support body 14, the intermediate support body 16 and the front end support body 18 are all provided with adhesive layers 14A, 16A and 18A on the lower surface in FIG.
  • the adhesive layer 18A of the tip support 18 is made to adhere to the skin or mucous membrane!
  • the intermediate support 16 is a sheet-like member that constitutes a part of the working electrode structure 20 and a part of the non-working electrode structure 40.
  • the tip support 18 is a sheet-like member that constitutes a part of the working electrode structure 20 and a part of the non-working electrode structure 40.
  • the working electrode structure 20 includes a working electrode 24 having the same polarity as the drug ions in the DC power source 12 and connected to the anode or the cathode, and a separator 26 disposed in front of the working electrode 24. And an intermediate ion-selective membrane 28 that is disposed in front of the separator 26 and selectively passes ions having opposite signs to the drug ions, and is disposed on the front surface of the intermediate ion-selective membrane 28 to become drug ions.
  • a drug solution holding unit 30 that holds a drug and a working ion selective membrane 32 that is disposed in front of the drug solution holding unit 30 and selectively passes the same type of ions as the drug ions are stacked in this order. Has been.
  • the working side electrode 24 is connected to the DC power source 12, and the working side current collector 24A made of a material containing a film-like carbon formed on the front surface of the resin sheet 36 by printing, and this action It is composed of a working side polarizable electrode 24B arranged in electrical connection with the front surface of the side current collector 24A.
  • Electrode connected includes not only the case of direct connection but also the case of connection via a conductive material such as a conductive adhesive (the same applies hereinafter).
  • the intermediate support 16 also has a grease material force having a thickness substantially equal to that of the working-side polarizable electrode 24B, and the working-side intermediate through having substantially the same shape as the outer shape of the working-side polarizable electrode 24B in plan view.
  • the working side polarizable electrode 24B has a hole 21A and is accommodated in the working side intermediate through hole 21A.
  • the tip support 18 also has a resin material force having a thickness substantially equal to that of the chemical solution holding part 30, and the working tip through-hole 22A having substantially the same shape as the planar shape of the working polarizable electrode 24B.
  • the drug solution holding part 30 is accommodated in the working side front end through hole 22A.
  • the non-working side electrode structure 40 includes a non-working side electrode 44 connected to an anode or a cathode having a polarity opposite to that of the drug ion in the DC power source 12 from the base support 14 side.
  • Electrode-side electrolyte holder 46 that holds the electrolyte
  • the tip-side electrolyte holder 48 that holds the same electrolyte
  • ions with the opposite sign to the drug ions A non-working side ion selective membrane 50 that is allowed to pass therethrough is laminated in this order.
  • the non-working electrode 44 is a non-working material made of carbon-containing material printed on the front surface of the resin sheet 36 and spaced from the working current collector 24A of the working electrode 24. It is composed of a side current collector 44A and a non-working side polarizable electrode 44B arranged in electrical connection with the front surface of the non-working side current collector 44A.
  • the non-working-side polarizable electrode 44B has the same thickness as the intermediate support 16, and is accommodated in the non-working-side intermediate through hole 41A formed therein.
  • the tip side electrolyte solution holding part 48 has the same thickness as the tip end support 18 and is accommodated in a non-working side tip through hole 42 A formed in the tip support 18.
  • the through holes 22A, 21A, 41A, 42A are all circular, and further, the working side electrode 24, the separator 26, the intermediate ion selective membrane 28, the chemical solution holding unit 30, and the working side ion selection.
  • the membrane 32 also has a circular membrane! /, Which is a sheet! /.
  • the non-working side electrode 44, the electrode side electrolyte holding unit 46, the tip side electrolyte holding unit 48, and the non-working side ion selective membrane 50 are also formed into a circular membrane or a sheet. .
  • the resin sheet 36 includes a working current collector 24A in the working electrode 24 and a non-working current collector 44A in the non-working electrode 44.
  • a working side conductor 19A and a non-working side conductor 19B made of a material containing carbon formed by continuous printing in a film form are connected to each other.
  • These working-side conducting wire 19A and non-working-side conducting wire 19B are connected to the DC power source 12 via a connector 19C at their tips.
  • an insulating film 19D having a polyimide film force, for example, is adhered to the side surfaces of the working side conductor 19A and the non-working side conductor 19B opposite to the resin sheet 36.
  • the insulating film 19D has a length that covers a range of the working-side conductor 19A and the non-working-side conductor 19B in contact with the resin sheet 36 and a certain range of a protruding portion from the resin sheet 36. In this embodiment, as shown in FIGS.
  • each circular member is arranged in the thickness direction in each of the working electrode structure 20 and the non-working electrode structure 40.
  • the iontophoresis device 10 is configured by overlapping and integrating, and as shown in FIG. 5, an iontophoresis system is configured by attaching a later-described release liner 58.
  • Reference numeral 56 in FIG. 4 denotes an adhesive, and this adhesive 56 is disposed across an intermediate portion between the active and non-active current collectors 24A and 44A in the insulating film 19D, Rum 19D and the intermediate support 16 are bonded, and the insulating film 19D and the intermediate support 16 are separated from the working side and the non-working side.
  • a release liner 58 provided with recesses 60 and 62 at positions corresponding to the working side ion selective membrane 32 and the non-working side ion selective membrane 50, respectively, can be peeled off.
  • a release liner 58 provided with recesses 60 and 62 at positions corresponding to the working side ion selective membrane 32 and the non-working side ion selective membrane 50, respectively, can be peeled off.
  • sponge 64 and 66 forces soaked with viscous liquid are respectively held.
  • the chemical solution holding unit 30 is configured by impregnating a PP (polypropylene) non-woven fabric with a viscous liquid containing a drug.
  • the drug impregnated in the drug solution holding unit 30 contains positive or negative ions (drugs that dissociate into drug ions (including drug precursors)) by dissolving in a solvent such as water.
  • positive or negative ions drugs that dissociate medicinal components into positive ions
  • examples of drugs that dissociate medicinal components into positive ions include lidocaine hydrochloride, which is an anesthetic, and morphine hydrochloride, which is an anesthetic, and vitamins that can be used to dissociate medicinal ingredients into anions. Examples include ascorbic acid and the like.
  • the electrode side electrolyte solution holding part 46 in the non-working side electrode structure 40 is made of a PP non-woven fabric with an electrolyte solution.
  • the tip side electrolyte solution holding part 48 is also made by impregnating a PP liquid nonwoven with a viscous liquid containing the same electrolyte solution.
  • the electrolyte used for the electrode side electrolyte holding part 46 and the tip side electrolyte holding part 48 is an electrolytic solution.
  • the main component of this electrolyte is an electrolyte that is more susceptible to oxidation or reduction than water electrolysis (oxidation at the anode and reduction at the cathode), such as ascorbic acid (vitamin C) and sodium ascorbate.
  • vitamin C ascorbic acid
  • the viscous liquid containing the drug or the electrolyte impregnated in the chemical solution holding unit 30 or the electrolyte solution holding units 46 and 48 is, for example, water (ion exchange water), HPC (hydroxypropyl cellulose) ( For example, Nippon Soda Co., Ltd.'s H-Type), or Metrose (for example, 9 OSH from Shin-Etsu Chemical Co., Ltd.) that has been treated with water-insoluble cellulose to form a water-soluble polymer. It can be produced by mixing 2% by mass or more of a thickener such as 10000SR).
  • a thickener such as 10000SR
  • the viscous liquid contained in the sponges 64 and 66 is, for example, water (ion exchange water), HPC (hydroxypropylcellulose) (for example, H-Type of Nippon Soda Co., Ltd.), or water. Manufactured by mixing 2% by mass or more of a thickener such as Metroise (for example, 90SH-10000SR from Shin-Etsu Chemical Co., Ltd.), which is a water-soluble polymer by chemically treating insoluble cellulose. Can do.
  • the viscous liquid contained in sponge 64 can be produced by calcining HPC with the chemical solution in water.
  • the viscous liquid contained in sponge 66 is obtained by adding HPC to the electrolyte solution in water. May be manufactured.
  • the method for producing the viscous liquid is not limited to the above method.
  • the viscous liquid may be a solution having a viscosity obtained by uniformly dissolving the water-soluble polymer in water.
  • Viscous liquid containing chemical solution is acceptable as long as it contains chemical solution, water, and water-soluble polymer.
  • Viscous liquid containing electrolyte solution is that containing electrolytic solution, water, and water-soluble polymer. That's fine.
  • the water-soluble polymer functions as a thickener. An appropriate amount of a water-soluble polymer is blended to adjust the viscosity of the electrolytic solution or chemical solution.
  • the water-soluble polymer used here is not particularly limited as long as the polymer is soluble in water.
  • Water-soluble polymers are classified into natural polymers, semi-synthetic polymers, and synthetic polymers. Can be any.
  • the water-soluble polymer can be layered into a ionic water-soluble polymer, a cationic water-soluble polymer, and a nonionic polymer according to electrical properties.
  • a ionic water-soluble polymer a cationic water-soluble polymer
  • a nonionic polymer a nonionic polymer according to electrical properties.
  • Use of nonionic water-soluble polymer is preferable to prevent gelling caused by pH change.
  • water-soluble polymers include cellulose polymers, polysaccharide polymers, water-soluble proteins, starch polymers, alginic acid polymers, acrylic polymers, vinyl polymers, and glycols. Based polymers and the like. In the present invention, it is preferable to use at least one selected from these water-soluble polymer forces.
  • Cellulosic polymers include methylcellulose (nonionic), ethylcellulose (nonionic), carboxymethylcellulose (aion), hydroxyethylcellulose (nonionic), hydroxypropylcellulose ( Nonionic), hydroxypropyl methylcellulose (nonionic), nitrocellulose (nonionic), cationized cellulose (cationic) and the like.
  • Polysaccharide polymers include gum arabic (a-on), carrageenan (a-on), guar gum (non-ionic), locust bean gum (non-ionic), pectin (non-ionic) ), Tragacanth, corn starch (non-ionic), xanthan gum (non-ionic), dextrin (non-ionic), cationic guagua gum (cationic), sodium hyaluronate (non-ionic), sodium chondroitin sulfate A, sodium chondroitin sulfate B, sodium chondroitin sulfate C (all of which are on), chitosan, chitosan derivatives, chitin, chitin derivatives and the like.
  • water-soluble protein examples include gelatin, elastin, collagen, BSA and the like.
  • starch-based polymer examples include phosphate starch.
  • alginic acid-based polymer examples include sodium alginate (a-on type), propylene glycol alginate (nonionic), and the like.
  • Acrylic polymers include sodium polyacrylate (a-on), carboxyvinyl polymer (non-ionic), polyacrylamide (non-ionic), and acrylamide 'atrely Copolymer (anionic) and the like.
  • bur polymer examples include polyvinyl pyrrolidone (nonionic), polybulu alcohol.
  • Nonionic vinylpyrrolidone vinylacetic acid copolymer (PVPZVA copolymer) (nonionic) and the like.
  • glycol polymers include polyethylene glycol (with a molecular weight of 20,000 to 5,000,000) (both are nonionic), a copolymer of polypropylene glycol and polyethylene glycol (PEO—PPO—PEO, Pluronic). , Proxamer) and the like.
  • hydroxyalkyl celluloses such as hydroxychetinoresenorelose, hydroxypropinoresenorelose, hydroxypropinoremethinocellulose and the like are more preferably used. Is particularly preferred.
  • Hydroxyalkyl cellulose can be produced by a known method, for example, by reacting an alkali cellulose with an alkylene oxide such as ethylene oxide or propylene oxide. Moreover, what was acquired as a commercial item can also be used as it is.
  • the amount of the water-soluble polymer to be used is not particularly limited as long as the water-soluble polymer to be used is in a range that can be uniformly dissolved in water. By increasing or decreasing the amount of the water-soluble polymer used within the range in which the water-soluble polymer used is uniformly dissolved in water, the viscosity of the resulting viscous liquid can be brought to a desired value.
  • the amount of the water-soluble polymer used is usually 0.1 to 50% by weight, preferably 1 to L0% by weight, more preferably 2 to 5% by weight, based on the whole viscous liquid.
  • the viscosity of the resulting viscous liquid is usually 0.05 Pa's or more.
  • the working-side polarizable electrode 24B in the working-side electrode 24 and the non-working-side polarizable electrode 44B in the non-working-side electrode 44 are both formed of activated carbon, preferably carbon fiber or carbon fiber paper! It is composed mainly of a conductive base material.
  • the layer may be formed by combining cloth and felt made of activated carbon fiber.
  • a layer in which activated carbon is dispersed in a binder polymer may be laminated on the conductive substrate.
  • the activated charcoal may have a specific surface area of 10m 2 Zg or more.
  • the working side polarizable electrode 24B has the same drug as the drug held in the drug solution holding unit 30.
  • the non-working-side polarizable electrode 44B is impregnated with a viscous liquid containing the same electrolytic solution as the electrolytic solution held in the electrode-side electrolytic solution holding part 46.
  • Both the working side current collector 24A in the working side electrode 24 and the non-working side current collector 44A in the non-working side electrode 44 are printed by mixing a PET (polyethylene terephthalate) material with carbon and an adhesive. Formed.
  • PET polyethylene terephthalate
  • the working current collector 24A and the non-working current collector 44A may be made of conductive materials such as gold, platinum, silver, copper, and zinc, in addition to carbon as long as they have conductivity. Other metals may be used. In addition, a conductive material itself such as carbon or gold that is printed can be used as the current collector. The same applies to the material of the working conductor 19A and the non-working conductor 19B.
  • the separator 26 is obtained by impregnating a PP non-woven fabric with a viscous liquid containing the same drug as the drug held in the drug solution holding unit 30, and includes the working side polarizable electrode 24B and the intermediate ion selective membrane. By interposing between the two, physical contact between the two is prevented.
  • the working-side ion-selective membrane 32 is configured to include an ion-exchange resin into which an ion-exchange group has been introduced so that ions having the same sign as drug ions can be selectively passed therethrough. That is, the working side ion-selective membrane 32 contains a cation exchange resin when dissociating into a chemical force S cation of the chemical solution holding unit 30, and contains an anion exchange resin when dissociating into a cation.
  • the intermediate ion selective membrane 28 is configured to contain an ion exchange resin into which an ion exchange group has been introduced so as to selectively pass ions having the opposite signs to the drug ions. That is, the intermediate ion-selective membrane 28 contains anion exchange resin when dissociating into the chemical force S cation of the chemical solution holding unit 30, and contains cation exchange resin when dissociating into the cation.
  • the non-working side ion-selective membrane 50 is an ion-exchange resin in which an ion-exchange group has been introduced so as to selectively pass drug ions and ions having opposite signs. It is comprised including. That is, the non-working side ion selective membrane 50 contains an anion exchange resin when dissociating into the chemical force S cation of the chemical solution holding unit 30 and contains a cation exchange resin when dissociating into the cation. Out.
  • Examples of the cation exchange resin include a three-dimensional network structure such as a polystyrene resin, a fluorocarbon resin having a perfluorocarbon skeleton, such as a hydrocarbon resin such as an acrylic resin.
  • An ion exchange resin in which a cation exchange group (an exchange group in which the counter ion is a cation) such as a sulfonic acid group, a carboxylic acid group, or a phosphonic acid group is introduced into a polymer having a structure may be used without limitation. I'll do it.
  • anion exchange resin a polymer having a three-dimensional network structure similar to that of the cation exchange resin may be added to primary to tertiary amine groups, quaternary ammonia groups, and pyrzyl.
  • An ion exchange resin into which a cation exchange group (an exchange group in which the counter ion is an anion) such as a group, an imidazole group, a quaternary pyridinium group, or a quaternary imidazolium group can be used without limitation.
  • the constituent members are arranged and stacked, or are stored in the through-holes, and the proximal support 14, intermediate The support body 16 and the tip support body 18 are sequentially stacked, and these are adhered and fixed by the adhesive layers 16A and 14A. Further, the release liner 58 is attached to the tip support body 18 to complete the assembly.
  • a button battery or a thin battery disclosed in, for example, Japanese Patent Application Laid-Open No. 11 067236, US Patent Publication No. 2004Z0185667A1, US Patent No. 6855441, or the like can be used. It is not limited to the structure of this embodiment.
  • the working current collector 24A and the non-working current collector 44A were printed electrodes on which a PET material mixed with carbon and an adhesive was printed.
  • an activated carbon fiber layer composed of a circular carbon having a diameter of 17 mm and a thickness of 1. Omm was formed.
  • the activated carbon fiber layer was impregnated with a viscous liquid in which water, HPC, and hydrochloric acid were mixed to form a working side polarizable electrode 24B.
  • the activated carbon fiber layer was impregnated with a viscous liquid in which water, HPC, and NaCl were mixed to form the non-working side polarizable electrode 44B.
  • the weight of each was 120-125 mg.
  • the separator 26 was composed of a PP nonwoven fabric having a diameter of 18 mm and a thickness of 0.1 mm, and was impregnated with a viscous liquid obtained by mixing HPC and lidocaine hydrochloride in water.
  • the intermediate ion selective membrane 28 was a key-on exchange membrane having a diameter of 21 mm and a thickness of 30 m.
  • the chemical solution holding unit 30 was obtained by impregnating a PP nonwoven fabric having a thickness of 1. Omm and a diameter of 17 mm with a viscous liquid obtained by mixing water, HPC, and lidocaine hydrochloride, and the weight was 250 to 320 mg.
  • the working ion selective membrane 32 was a cation exchange membrane having a thickness of 30 ⁇ m and a diameter of 19 mm.
  • the area of the working ion selective membrane 32 is determined in consideration of the current value. For example, if the current value is 1 mA, a diameter 19 mm, the current density is 0. 35mAZcm 2.
  • a medicinal cation (lid power in) is substituted with an ion exchange group.
  • the electrode-side electrolyte holding part 46 in the non-working-side electrode structure 40 has a configuration in which a PP non-woven fabric is impregnated with the same viscous liquid containing NaCl as that used in the non-working-side polarizable electrode 44B, and has a diameter of 18 mm. The thickness was 100 m. Further, the tip side electrolyte solution holding part 48 is obtained by impregnating a PP non-woven fabric having a diameter of 17 mm and a thickness of 1 mm with the same viscous liquid as described above, and the weight is 250 to 320 mg.
  • the non-acting side ion selective membrane 50 is a key-on exchange membrane having a thickness of 30 m and a diameter of 21 mm, in which chloride ions are substituted with ion exchange groups.
  • the viscous liquid 70 is held in the sponges 64 and 66 provided in the recesses 60 and 62 of the release liner 58, so that the viscous liquid 70 is easily ionized. It can be attached to the selective membrane 32, 50. Therefore, when the iontophoresis device 10 is attached to the skin of a living body, the release liner 58 is peeled off so that a viscous liquid 70 is not formed between the ion selective membranes 32 and 50 and the skin as shown in FIG. A living body contact portion 72 is formed. Therefore, it is possible to easily attach a viscous liquid as compared with attaching a release liner by attaching a viscous liquid to an ion selective membrane.
  • the viscous liquid 70 improves the adhesion between the skin and the ion-selective membranes 32 and 50, can exhibit the performance of the ion-selective membrane, and sufficiently delivers the drug ions in the drug holding unit 30 to the skin. be able to.
  • the amount of the viscous liquid 70 adhering to the ion selective membranes 32 and 50 can be adjusted by adjusting the amount of the viscous liquid 70 to be immersed in the sponge.
  • the method of interposing the viscous liquid 70 is not limited to the above-described embodiment, and the V-deviation or one of the sponges 64, 66 can be omitted. Also, immediately before mounting on the living body, the mounting surface side of the iontophoresis device 10 is covered with the release liner 58, and the viscous liquid 70 is ionized. The biological contact portion 72 can also be formed by attaching the iontophoresis device 10 to the skin in a state of being attached to the attachment surface of the tophoresis device 10.
  • the viscous liquid 70 is soaked in the sponges 64 and 66, which are continuous foams, and covered with the release liner 58, so that the remaining amount can be controlled and drying during storage is prevented. it can. Further, since the sponges 64 and 66 are accommodated in the recesses 60 and 62, the viscous liquid 70 can be prevented from spreading too much, and a desired amount of viscous liquid per area can be secured. Furthermore, it does not adhere to unnecessary places and is easy to handle.
  • the force provided with the separator 26 prevents direct contact between the working polarizable electrode 24B and the intermediate ion-selective membrane 28. This is to prevent the occurrence of bubbles such as chlorine gas in the vicinity of the intermediate ion-selective membrane 28 and thereby impair the conductivity in the electrode structure, and direct contact can be prevented by other means. The case is not necessary. Even if the working side polarizable electrode 24B and the intermediate ion selective membrane 28 are in direct contact with each other, bubbles such as chlorine gas are not generated near the intermediate ion selective membrane 28 when energized. In some cases, no means for preventing direct contact between the two, such as separator 26, is required.
  • the electrode side electrolyte solution holding part 46 and the tip side electrolyte solution holding part 48 are common to the configuration in which a PP nonwoven fabric is impregnated with a viscous liquid containing an electrolyte solution. May be configured.
  • the present invention relates to a tomatophoresis system comprising an iontophoresis device for administering drug ions to a living body by applying a voltage, and more particularly, to the skin of an organism and the iontophoresis device ion. It is possible to provide an iontophoresis system that can easily improve the adhesion of a selective membrane and deliver drug ions evenly.

Abstract

In order to apply to the skin of a living body an iontophoresis system (10) which comprises a DC power supply (12), a working side electrode structure (20) connected with one of the anode and cathode of the DC power supply, and a non-working side electrode structure (40) connected with the other, and which doses the living body with drug ions held on the working side electrode structure by applying a voltage from the DC power supply, a release liner (58) provided with the holding portions (sponges (64, 66) in recesses (60, 62)) of viscous liquid (70) covering the living body sides of the working side ion selectivity film (32) and the non-working side ion selectivity film (50) of the iontophoresis system (10) is employed. Consequently, adhesion between the skin and the ion selectivity films is enhanced simply, and delivery of drug ions can be increased by exhibiting the performance of ion selectivity films sufficiently.

Description

明 細 書  Specification
イオントフォレーシスシステム  Iontophoresis system
技術分野  Technical field
[0001] 本発明は、薬物イオンを、電圧を印加することによって生体に投与するためのィォ ントフォレーシス装置を備えたイオントフォレーシスシステムに係り、特に、生体の皮 膚とイオントフォレーシス装置のイオン選択性膜の密着性を簡単に高めて、薬物ィォ ンをむらなく送達することが可能なイオントフォレーシスシステムに関する。  TECHNICAL FIELD [0001] The present invention relates to an iontophoresis system including an iontophoresis device for administering drug ions to a living body by applying a voltage, and in particular, the skin of the living body and the iontophoresis device. The present invention relates to an iontophoresis system that can easily improve the adhesion of an ion-selective membrane and deliver drug ions evenly.
背景技術  Background art
[0002] 薬物イオンを、電圧を印加することによって生体に投与するためのイオントフォレー シス装置としては、 WO03037425号公報 (特許文献 1)に記載されるように、作用側 電極構造体及び非作用側電極構造体を有し、作用側電極構造体のイオン交換膜か ら薬液イオンを、皮膚や粘膜に投与させるものがある。  [0002] As an iontophoresis device for administering drug ions to a living body by applying a voltage, as described in WO03037425 (Patent Document 1), a working electrode structure and a non-action Some have side electrode structures that allow medicinal ions to be administered to the skin and mucous membranes from the ion exchange membrane of the working electrode structure.
[0003] この特許文献 1に記載されるイオントフォレーシス装置における作用側電極構造体 は、皮膚や粘膜との接触側から、イオン交換膜、薬液保持部、イオン交換膜、電解液 保持部、作用側電極を、この順で積層して構成されている。 [0003] The working electrode structure in the iontophoresis device described in Patent Document 1 includes, from the contact side with the skin or mucous membrane, an ion exchange membrane, a chemical solution holding unit, an ion exchange membrane, an electrolyte holding unit, The working side electrodes are stacked in this order.
[0004] 又、非作用側電極構造体は、皮膚や粘膜との接触側から、イオン交換膜、電解液 保持部、イオン交換膜、電解液保持部及び非作用側電極を、この順で積層して構成 されている。 [0004] Further, the non-working side electrode structure is formed by laminating an ion exchange membrane, an electrolytic solution holding unit, an ion exchange membrane, an electrolytic solution holding unit, and a non-working side electrode in this order from the contact side with the skin or mucous membrane. Configured.
[0005] この特許文献 1記載のイオントフォレーシス装置では、生体の皮膚とイオン交換膜 は密着させるもので、間に物が入らない方が良いとされていた力 特に皮膚の凹凸が 大きい場合には、イオン交換膜と皮膚に隙間が生じて密着が十分でなぐイオン交換 膜の性能を十分に発揮できず、薬物イオンを十分に送達することができな 、と 、う問 題点がある。  [0005] In the iontophoresis device described in Patent Document 1, the skin of the living body and the ion exchange membrane are brought into close contact with each other. However, there is a problem in that the ion exchange membrane with sufficient gap due to a gap between the ion exchange membrane and the skin cannot be fully used and drug ions cannot be delivered sufficiently. .
[0006] なお、イオントフォレーシス装置装着前にイオントフォレーシス装置側又は皮膚に接 触用液体を塗布して皮膚との密着性を高めることも考えられるが、装着前に一々液 体を塗布するのは面倒である。  [0006] It is also conceivable to apply a contact liquid to the iontophoresis device side or the skin before wearing the iontophoresis device to improve the adhesion to the skin. It is troublesome to apply.
発明の開示 [0007] この発明は、簡易に接触用液体を介在させて、イオン交換膜等のイオン選択性膜と 皮膚の隙間を無くして密着性を高め、薬物イオンを十分に皮膚に送達することができ る技術を提供することを解決課題とする。 Disclosure of the invention [0007] The present invention can easily deliver drug ions to the skin by simply interposing a contact liquid, eliminating the gap between the ion-selective membrane such as an ion exchange membrane and the skin and improving adhesion. The problem to be solved is to provide technologies that can be used.
[0008] 本発明は、直流電源と、この直流電源の陽極及び陰極の一方に接続された作用側 電極構造体及び他方に接続された非作用側電極構造体とから構成され、前記作用 側電極構造体に保持される薬物イオンを、前記直流電源からの電圧によって生体に 投与するためのイオントフォレーシス装置であって、前記作用側電極構造体は、前記 薬物イオンと同種の極性の、前記陽極又は陰極に接続された作用側電極と、この作 用側電極と電気的に接続され、前記薬物イオンとなる薬物を保持する薬液保持部と 、前記薬液保持部と電気的に接続され、前記薬物イオンと同種のイオンを選択的に 通過させる作用側イオン選択性膜と、を少なくとも有してなるイオントフォレーシス装 置と、該イオントフォレーシス装置の作用側イオン選択性膜の生体側をカバーするた めの、粘性液体保持部が設けられたリリースライナーと、を備えたことを特徴とするィ オントフォレーシスシステム〖こより、上記課題を解決したものである。  The present invention comprises a DC power supply, a working electrode structure connected to one of an anode and a cathode of the DC power supply, and a non-working electrode structure connected to the other, and the working electrode An iontophoresis device for administering a drug ion held in a structure to a living body by a voltage from the DC power source, wherein the working electrode structure has the same kind of polarity as the drug ion. A working electrode connected to an anode or a cathode; a drug solution holding unit electrically connected to the working side electrode for holding a drug to be the drug ion; and electrically connected to the drug solution holding unit; An iontophoresis device having at least a working ion selective membrane that selectively allows the same kind of ions as drug ions to pass through, and a living body side of the working ion selective membrane of the iontophoresis device The order to cover, characterized by comprising a release liner viscous liquid holding portion is provided, the Onto Foret over cis system 〖Koyori is obtained by solving the above problems.
[0009] 本発明は、又、直流電源と、この直流電源の陽極及び陰極の一方に接続された作 用側電極構造体及び他方に接続された非作用側電極構造体とから構成され、前記 作用側電極構造体に保持される薬物イオンを、前記直流電源からの電圧によって生 体に投与するためのイオントフォレーシス装置であって、前記非作用側電極構造体 は、前記薬物イオンと反対の極性の、前記陽極又は陰極に接続された非作用側電 極と、この作用側電極と電気的に接続され、電解液を保持する電解液保持部と、この 電解液保持部と電気的に接続され、前記薬物イオンと反対のイオンを選択的に通過 させる非作用側イオン選択性膜と、を少なくとも有してなるイオントフォレーシス装置と 、該イオントフォレーシス装置の非作用側イオン選択性膜の生体側をカバーするため の、粘性液体保持部が設けられたリリースライナーと、を備えたことを特徴とするィォ ントフォレーシスシステムにより、上記課題を解決したものである。  [0009] The present invention is also composed of a DC power source, a working side electrode structure connected to one of an anode and a cathode of the DC power source and a non-working side electrode structure connected to the other, An iontophoresis device for administering drug ions held in a working electrode structure to a living body by a voltage from the DC power source, wherein the non-working electrode structure is opposite to the drug ions. A non-working-side electrode connected to the anode or cathode, an electrolyte-holding unit electrically connected to the working-side electrode and holding the electrolyte, and an electrical connection with the electrolyte-holding unit An iontophoresis device having at least a non-working side ion selective membrane connected and selectively allowing ions opposite to the drug ions to pass therethrough, and non-working side ion selection of the iontophoresis device The biological side of the membrane For bars, and release liner viscous liquid holding portion is provided by I O cement Foret over cis system comprising the one in which the above-mentioned problems are eliminated.
[0010] 前記粘性液体保持部は、リリースライナーの凹部に配設されたスポンジ等の連続発 泡体を含むことができる。  [0010] The viscous liquid holding portion may include a continuous foamed body such as a sponge disposed in a recess of the release liner.
[0011] 又、前記粘性液体は、水に水溶性高分子を混合したものとすることができる。 [0012] 更に、前記粘性液体に、薬物保持部の薬物と同じ薬物又は電解液保持部の電解 液と同じ電解液を含めることもできる。 [0011] The viscous liquid may be a mixture of water and a water-soluble polymer. [0012] Further, the viscous liquid may include the same drug as the drug in the drug holding unit or the same electrolytic solution as the electrolytic solution in the electrolytic solution holding unit.
[0013] この発明にお ヽては、粘性液体保持部を有するリリースライナーを用いて粘性液体 を保持するようにしたので、イオン選択性膜に簡易に粘性液体を付着させることがで き、イオン選択性膜と皮膚の密着性を高めて、薬物イオンを皮膚に十分に送達するこ とがでさる。 [0013] In the present invention, the viscous liquid is retained using the release liner having the viscous liquid retaining portion, so that the viscous liquid can be easily attached to the ion selective membrane. It improves the adhesion between the selective membrane and the skin and allows sufficient delivery of drug ions to the skin.
図面の簡単な説明  Brief Description of Drawings
[0014] [図 1]本発明の実施の形態に係るイオントフォレーシスシステムを示す分解斜視図 [図 2]同イオントフォレーシスシステムのイオントフォレーシス装置における作用側電 極及び非作用側電極部分を拡大して示す平面図  FIG. 1 is an exploded perspective view showing an iontophoresis system according to an embodiment of the present invention. FIG. 2 is a working side electrode and a non-working side in an iontophoresis device of the iontophoresis system. Plan view showing enlarged electrode part
[図 3]図 2の III III線に沿う拡大断面図  [Figure 3] Enlarged sectional view along line III-III in Figure 2
[図 4]同イオントフォレーシスシステムを示す分解断面図  [Fig.4] Exploded sectional view showing the iontophoresis system
[図 5]同イオントフォレーシスシステムの組立状態を示す断面図  [Fig.5] Sectional view showing the assembled state of the iontophoresis system
[図 6]同イオントフォレーシスシステムのリリースライナーの装着状態を示す断面図 [図 7]イオントフォレーシス装置の皮膚への装着状態を示す断面図  [Fig. 6] Cross-sectional view showing the state of wearing the release liner of the iontophoresis system [Fig. 7] Cross-sectional view showing the wearing state of the iontophoresis device on the skin
発明を実施するための最良の形態  BEST MODE FOR CARRYING OUT THE INVENTION
[0015] 次に、図 1〜図 4を参照して、本発明の実施の形態の例に係るイオントフォレーシス システムについて詳細に説明する。  Next, an iontophoresis system according to an example of an embodiment of the present invention will be described in detail with reference to FIGS.
[0016] このイオントフォレーシスシステムを構成するイオントフォレーシス装置 10は、直流 電源 12と、この直流電源 12の陽極及び陰極の一方に接続された作用側電極構造 体 20及び他方に接続された非作用側電極構造体 40とから構成され、作用側電極構 造体 20に保持される薬物イオンを、直流電源 12からの電圧によって生体に投与する ものである。  An iontophoresis device 10 constituting the iontophoresis system is connected to a DC power source 12, a working electrode structure 20 connected to one of an anode and a cathode of the DC power source 12, and the other. The non-working side electrode structure 40 is configured to administer drug ions held in the working side electrode structure 20 to the living body by the voltage from the DC power source 12.
[0017] このイオントフォレーシス装置 10において、作用側電極構造体 20及び非作用側電 極構造体 40は、薬液保持部等の構成部材を、重ね合わせた、いずれも榭脂シート 力もなる基端支持体 14と中間支持体 16との間に挟持し、あるいは中間支持体 16及 び先端支持体 18に形成される貫通孔に収納して構成されている。基端支持体 14と 中間支持体 16とは同一の大きさとされ、又、先端支持体 18はこれらより大きく形成さ れている。 [0017] In the iontophoresis device 10, the working electrode structure 20 and the non-working electrode structure 40 are formed by superposing constituent members such as a chemical solution holding unit, and each of them is a base that also has a resin sheet force. It is configured to be sandwiched between the end support 14 and the intermediate support 16 or housed in a through hole formed in the intermediate support 16 and the tip support 18. The proximal support 14 and the intermediate support 16 are the same size, and the distal support 18 is formed larger than these. It is.
[0018] 基端支持体 14、中間支持体 16及び先端支持体 18は、いずれも図 4において下側 面に粘着層 14A、 16 A, 18Aが設けられていて、相互に粘着されるとともに、先端支 持体 18の粘着層 18Aは、皮膚又は粘膜に粘着するようにされて!、る。  [0018] The base end support body 14, the intermediate support body 16 and the front end support body 18 are all provided with adhesive layers 14A, 16A and 18A on the lower surface in FIG. The adhesive layer 18A of the tip support 18 is made to adhere to the skin or mucous membrane!
[0019] ここで、中間支持体 16は、作用側電極構造体 20の一部、及び、非作用側電極構 造体 40の一部を構成する一枚のシート状部材とされている。  Here, the intermediate support 16 is a sheet-like member that constitutes a part of the working electrode structure 20 and a part of the non-working electrode structure 40.
[0020] 同様に、先端支持体 18は、作用側電極構造体 20の一部、及び、非作用側電極構 造体 40の一部を構成する一枚のシート状部材とされている。  Similarly, the tip support 18 is a sheet-like member that constitutes a part of the working electrode structure 20 and a part of the non-working electrode structure 40.
[0021] 作用側電極構造体 20は、直流電源 12における薬物イオンと同種の極性の、陽極 又は陰極に接続された作用側電極 24と、この作用側電極 24の前面に配置されたセ パレータ 26と、このセパレータ 26の前面に配置され、薬物イオンと反対符号のイオン を選択的に通過させる中間イオン選択性膜 28と、この中間イオン選択性膜 28の前 面に配置され、薬物イオンとなる薬物を保持する薬液保持部 30と、薬液保持部 30の 前面に配置され、薬物イオンと同種のイオンを選択的に通過させる作用側イオン選 択性膜 32とを、この順で積層して構成されている。  [0021] The working electrode structure 20 includes a working electrode 24 having the same polarity as the drug ions in the DC power source 12 and connected to the anode or the cathode, and a separator 26 disposed in front of the working electrode 24. And an intermediate ion-selective membrane 28 that is disposed in front of the separator 26 and selectively passes ions having opposite signs to the drug ions, and is disposed on the front surface of the intermediate ion-selective membrane 28 to become drug ions. A drug solution holding unit 30 that holds a drug and a working ion selective membrane 32 that is disposed in front of the drug solution holding unit 30 and selectively passes the same type of ions as the drug ions are stacked in this order. Has been.
[0022] 作用側電極 24は、直流電源 12に接続され、且つ、榭脂シート 36の前面に印刷に より形成された膜状の炭素を含む材料からなる作用側集電体 24Aと、この作用側集 電体 24Aの前面に電気的に接続して配置された作用側分極性電極 24Bとから構成 されている。  [0022] The working side electrode 24 is connected to the DC power source 12, and the working side current collector 24A made of a material containing a film-like carbon formed on the front surface of the resin sheet 36 by printing, and this action It is composed of a working side polarizable electrode 24B arranged in electrical connection with the front surface of the side current collector 24A.
[0023] なお、「電気的に接続」とは、直接接続して!/ヽる場合のみでなぐ導電体、例えば導 電性接着剤等を介して接続する場合も含むものである (以下同じ)。  “Electrically connected” includes not only the case of direct connection but also the case of connection via a conductive material such as a conductive adhesive (the same applies hereinafter).
[0024] 中間支持体 16は、作用側分極性電極 24Bとほぼ等しい厚さの榭脂材料力もなり、 且つ、この作用側分極性電極 24Bの平面形状における外形とほぼ同一形状の作用 側中間貫通孔 21 Aを有し、作用側分極性電極 24Bは、作用側中間貫通孔 21A内に 収納されている。  [0024] The intermediate support 16 also has a grease material force having a thickness substantially equal to that of the working-side polarizable electrode 24B, and the working-side intermediate through having substantially the same shape as the outer shape of the working-side polarizable electrode 24B in plan view. The working side polarizable electrode 24B has a hole 21A and is accommodated in the working side intermediate through hole 21A.
[0025] 又、先端支持体 18は、薬液保持部 30とほぼ等しい厚さの榭脂材料力もなり、作用 側分極性電極 24Bの平面形状における外形とほぼ同一形状の作用側先端貫通孔 2 2Aを有し、この作用側先端貫通孔 22A内に、薬液保持部 30が収納されている。 [0026] 非作用側電極構造体 40は、基端支持体 14側から、直流電源 12における、薬物ィ オンと反対の極性の、陽極又は陰極に接続された非作用側電極 44と、この非作用側 電極 44の前面に配置され、電解液を保持する電極側電解液保持部 46と、同様の電 解液を保持する先端側電解液保持部 48と、薬物イオンと反対符号のイオンを選択的 に通過させる非作用側イオン選択性膜 50とを、この順で積層して構成されて!ヽる。 [0025] The tip support 18 also has a resin material force having a thickness substantially equal to that of the chemical solution holding part 30, and the working tip through-hole 22A having substantially the same shape as the planar shape of the working polarizable electrode 24B. The drug solution holding part 30 is accommodated in the working side front end through hole 22A. [0026] The non-working side electrode structure 40 includes a non-working side electrode 44 connected to an anode or a cathode having a polarity opposite to that of the drug ion in the DC power source 12 from the base support 14 side. Select the electrode-side electrolyte holder 46 that holds the electrolyte, the tip-side electrolyte holder 48 that holds the same electrolyte, and ions with the opposite sign to the drug ions. A non-working side ion selective membrane 50 that is allowed to pass therethrough is laminated in this order.
[0027] 非作用側電極 44は、榭脂シート 36の前面に、作用側電極 24の作用側集電体 24 Aと離間して膜状に印刷された炭素を含む材料カゝらなる非作用側集電体 44Aと、こ の非作用側集電体 44Aの前面に電気的に接続して配置された非作用側分極性電 極 44Bとから構成されて!、る。  [0027] The non-working electrode 44 is a non-working material made of carbon-containing material printed on the front surface of the resin sheet 36 and spaced from the working current collector 24A of the working electrode 24. It is composed of a side current collector 44A and a non-working side polarizable electrode 44B arranged in electrical connection with the front surface of the non-working side current collector 44A.
[0028] 非作用側分極性電極 44Bは、中間支持体 16と等しい厚さとされ、これに形成され た非作用側中間貫通孔 41Aに収納されている。又、先端側電解液保持部 48は、先 端支持体 18と等しい厚さとされ、先端支持体 18に形成された非作用側先端貫通孔 42Aに収納されている。  [0028] The non-working-side polarizable electrode 44B has the same thickness as the intermediate support 16, and is accommodated in the non-working-side intermediate through hole 41A formed therein. The tip side electrolyte solution holding part 48 has the same thickness as the tip end support 18 and is accommodated in a non-working side tip through hole 42 A formed in the tip support 18.
[0029] この実施例において、貫通孔 22A、 21A、 41A、 42Aはいずれも円形とされ、更に 、作用側電極 24、セパレータ 26、中間イオン選択性膜 28、薬液保持部 30及び作用 側イオン選択性膜 32も、円形膜状ある!/、はシート状とされて!/、る。  In this embodiment, the through holes 22A, 21A, 41A, 42A are all circular, and further, the working side electrode 24, the separator 26, the intermediate ion selective membrane 28, the chemical solution holding unit 30, and the working side ion selection. The membrane 32 also has a circular membrane! /, Which is a sheet! /.
[0030] 同様に、非作用側電極 44、電極側電解液保持部 46、先端側電解液保持部 48及 び非作用側イオン選択性膜 50も、円形の膜あるいはシート状とされて 、る。  [0030] Similarly, the non-working side electrode 44, the electrode side electrolyte holding unit 46, the tip side electrolyte holding unit 48, and the non-working side ion selective membrane 50 are also formed into a circular membrane or a sheet. .
[0031] 図 2、図 3に拡大して示されるように、榭脂シート 36には、作用側電極 24における作 用側集電体 24A及び非作用側電極 44における非作用側集電体 44Aに、連続的に 膜状に印刷して形成された炭素を含む材料からなる作用側導線 19A及び非作用側 導線 19Bがそれぞれ接続されている。  [0031] As shown in FIGS. 2 and 3 in an enlarged manner, the resin sheet 36 includes a working current collector 24A in the working electrode 24 and a non-working current collector 44A in the non-working electrode 44. In addition, a working side conductor 19A and a non-working side conductor 19B made of a material containing carbon formed by continuous printing in a film form are connected to each other.
[0032] これらの作用側導線 19A及び非作用側導線 19Bは、その先端においてコネクタ 19 Cを介して直流電源 12に接続されている。又、作用側導線 19A及び非作用側導線 1 9Bの榭脂シート 36と反対側面には、例えばポリイミドフィルム力もなる絶縁フィルム 1 9Dが粘着されている。この絶縁フィルム 19Dは、作用側導線 19A及び非作用側導 線 19Bの、榭脂シート 36と接触する範囲及び榭脂シート 36からの突出部分の一定 範囲を覆う長さとされている。 [0033] この実施形態においては、図 1、図 4に示されるように、円形の各部材を作用側電 極構造体 20と非作用側電極構造体 40のそれぞれにお ヽて厚さ方向に重ねて配置 し、一体的にして、イオントフォレーシス装置 10が構成され、更に、図 5に示されるよう に、後出リリースライナー 58を貼り付けてイオントフォレーシスシステムが構成されて いる。 [0032] These working-side conducting wire 19A and non-working-side conducting wire 19B are connected to the DC power source 12 via a connector 19C at their tips. Also, an insulating film 19D having a polyimide film force, for example, is adhered to the side surfaces of the working side conductor 19A and the non-working side conductor 19B opposite to the resin sheet 36. The insulating film 19D has a length that covers a range of the working-side conductor 19A and the non-working-side conductor 19B in contact with the resin sheet 36 and a certain range of a protruding portion from the resin sheet 36. In this embodiment, as shown in FIGS. 1 and 4, each circular member is arranged in the thickness direction in each of the working electrode structure 20 and the non-working electrode structure 40. The iontophoresis device 10 is configured by overlapping and integrating, and as shown in FIG. 5, an iontophoresis system is configured by attaching a later-described release liner 58.
[0034] 図 4の符号 56は接着剤を示し、この接着剤 56は、絶縁フィルム 19Dにおける作用 側及び非作用側集電体 24A、 44Aの間の中間部分を横断して配置され、絶縁フィ ルム 19Dと中間支持体 16を接着し、絶縁フィルム 19Dと中間支持体 16との間を作 用側と非作用側とに隔絶させるものである。  [0034] Reference numeral 56 in FIG. 4 denotes an adhesive, and this adhesive 56 is disposed across an intermediate portion between the active and non-active current collectors 24A and 44A in the insulating film 19D, Rum 19D and the intermediate support 16 are bonded, and the insulating film 19D and the intermediate support 16 are separated from the working side and the non-working side.
[0035] 前記先端支持体 18の前面には、作用側イオン選択性膜 32及び非作用側イオン選 択性膜 50にそれぞれ対応する位置に凹部 60、 62が設けられたリリースライナー 58 力 剥離可能に貼り付けられて、イオントフォレーシスシステムが構成される。図 6に 示す如ぐこのリリースライナー 58の凹部 60、 62の中には、粘性液体を染み込ませ たスポンジ 64、 66力 それぞれ保持されている。  [0035] On the front surface of the tip support 18, a release liner 58 provided with recesses 60 and 62 at positions corresponding to the working side ion selective membrane 32 and the non-working side ion selective membrane 50, respectively, can be peeled off. To form an iontophoresis system. As shown in FIG. 6, in the recesses 60 and 62 of the release liner 58, sponge 64 and 66 forces soaked with viscous liquid are respectively held.
[0036] 次に、上記各構成要素の材料、成分等について説明する。  [0036] Next, materials, components, and the like of the respective constituent elements will be described.
[0037] この実施形態において、薬液保持部 30は、 PP (ポリプロピレン)不織布に薬物を含 む粘性液体を含浸させて構成されている。又、薬液保持部 30に含浸された薬物は、 水等の溶媒に溶解するなどにより薬効成分が陽又は陰のイオン (薬物イオンに解離 する薬剤 (薬剤の前駆体を含む) )を含有し、薬効成分が陽のイオンに解離する薬剤 としては、麻酔薬である塩酸リドカイン、麻酔薬である塩酸モルヒネ等を例示すること ができ、薬効成分が陰イオンに解離する薬剤としては、ビタミン剤であるァスコルビン 酸等を例示することができる。  In this embodiment, the chemical solution holding unit 30 is configured by impregnating a PP (polypropylene) non-woven fabric with a viscous liquid containing a drug. In addition, the drug impregnated in the drug solution holding unit 30 contains positive or negative ions (drugs that dissociate into drug ions (including drug precursors)) by dissolving in a solvent such as water. Examples of drugs that dissociate medicinal components into positive ions include lidocaine hydrochloride, which is an anesthetic, and morphine hydrochloride, which is an anesthetic, and vitamins that can be used to dissociate medicinal ingredients into anions. Examples include ascorbic acid and the like.
[0038] 又、上記の他に、ホルモン、 DNA、 RNA、蛋白質、アミノ酸、ミネラル類、リポソ一 ムも含むものとする。 [0038] In addition to the above, hormones, DNA, RNA, proteins, amino acids, minerals, and liposomes are also included.
[0039] 非作用側電極構造体 40における電極側電解液保持部 46は、 PP不織布に電解液  [0039] The electrode side electrolyte solution holding part 46 in the non-working side electrode structure 40 is made of a PP non-woven fabric with an electrolyte solution.
(詳細後述)を含む粘性液体を含浸させたものである。又、先端側電解液保持部 48 も、 PP不織布に同様の電解液を含む粘性液体を含浸させたものである。  It is impregnated with a viscous liquid containing (described later in detail). The tip side electrolyte solution holding part 48 is also made by impregnating a PP liquid nonwoven with a viscous liquid containing the same electrolyte solution.
[0040] 電極側電解液保持部 46及び先端側電解液保持部 48に用いられる電解液は電解 質を主成分とし、この電解質は、水の電解反応(陽極での酸ィ匕及び陰極での還元)よ りも酸化又は還元され易い電解質、例えば、ァスコルビン酸 (ビタミン C)やァスコルビ ン酸ナトリウム等の医薬剤、乳酸、シユウ酸、リンゴ酸、コハク酸、フマル酸等の有機 酸及び Z又はその塩を使用することが特に好ましぐこれにより酸素ガスや水素ガス の発生を抑制することが可能であり、又、溶媒に溶解した際に緩衝電解液となる組合 せの複数種の電解質を配合することにより、通電中における pHの変動を抑制するこ とがでさる。 [0040] The electrolyte used for the electrode side electrolyte holding part 46 and the tip side electrolyte holding part 48 is an electrolytic solution. The main component of this electrolyte is an electrolyte that is more susceptible to oxidation or reduction than water electrolysis (oxidation at the anode and reduction at the cathode), such as ascorbic acid (vitamin C) and sodium ascorbate. It is particularly preferable to use pharmaceutical agents such as lactic acid, oxalic acid, malic acid, succinic acid, fumaric acid and the like and Z or a salt thereof, thereby suppressing the generation of oxygen gas and hydrogen gas. It is possible to suppress fluctuations in pH during energization by blending multiple types of electrolytes that are combined into a buffer electrolyte when dissolved in a solvent.
[0041] ここで、薬液保持部 30あるいは電解液保持部 46、 48に含浸される、薬物あるいは 電解液を含む粘性液体は、例えば水 (イオン交換水)に、 HPC (ヒドロキシプロピルセ ルロース) (例えば日本曹達 (株)の H— Type)、あるいは、水に溶けないセルロース をィ匕学的に処理して水溶性の高分子としたメトローズ (例えば信越ィ匕学工業 (株)の 9 OSH— 10000SR)等の増粘剤を 2質量%以上混合して製造することができる。  [0041] Here, the viscous liquid containing the drug or the electrolyte impregnated in the chemical solution holding unit 30 or the electrolyte solution holding units 46 and 48 is, for example, water (ion exchange water), HPC (hydroxypropyl cellulose) ( For example, Nippon Soda Co., Ltd.'s H-Type), or Metrose (for example, 9 OSH from Shin-Etsu Chemical Co., Ltd.) that has been treated with water-insoluble cellulose to form a water-soluble polymer. It can be produced by mixing 2% by mass or more of a thickener such as 10000SR).
[0042] 又、スポンジ 64、 66に含ませる粘性液体は、例えば水 (イオン交換水)に、 HPC (ヒ ドロキシプロピルセルロース)(例えば日本曹達 (株)の H— Type)、あるいは、水に溶 けないセルロースをィ匕学的に処理して水溶性の高分子としたメトローズ (例えば信越 化学工業 (株)の 90SH— 10000SR)等の増粘剤を 2質量%以上混合して製造する ことができる。又、スポンジ 64に含ませる粘性液体は、水に薬液をカロえたものに HPC をカロえて製造したものでもよぐスポンジ 66に含ませる粘性液体は、水に電解液をカロ えたものに HPCを加えて製造したものでもよい。  [0042] The viscous liquid contained in the sponges 64 and 66 is, for example, water (ion exchange water), HPC (hydroxypropylcellulose) (for example, H-Type of Nippon Soda Co., Ltd.), or water. Manufactured by mixing 2% by mass or more of a thickener such as Metroise (for example, 90SH-10000SR from Shin-Etsu Chemical Co., Ltd.), which is a water-soluble polymer by chemically treating insoluble cellulose. Can do. In addition, the viscous liquid contained in sponge 64 can be produced by calcining HPC with the chemical solution in water.The viscous liquid contained in sponge 66 is obtained by adding HPC to the electrolyte solution in water. May be manufactured.
[0043] また、粘性液体を作製する方法は上記方法に限定されるものではな 、。粘性液体 は、水溶性高分子が水に均一に溶解してなる粘性を有する溶液であればよい。薬液 を含有する粘性液体は、薬液、水及び水溶性高分子を含有するものであればよぐ 電解液を含有する粘性液体は、電解液、水及び水溶性高分子を含有するものであ ればよい。  [0043] Further, the method for producing the viscous liquid is not limited to the above method. The viscous liquid may be a solution having a viscosity obtained by uniformly dissolving the water-soluble polymer in water. Viscous liquid containing chemical solution is acceptable as long as it contains chemical solution, water, and water-soluble polymer. Viscous liquid containing electrolyte solution is that containing electrolytic solution, water, and water-soluble polymer. That's fine.
[0044] 水溶性高分子は増粘剤として機能するものである。水溶性高分子を適量配合して 上記電解液又は薬液の粘度を調整する。  [0044] The water-soluble polymer functions as a thickener. An appropriate amount of a water-soluble polymer is blended to adjust the viscosity of the electrolytic solution or chemical solution.
[0045] ここで用いる水溶性高分子としては、水に溶解する高分子であれば特に制限され ない。水溶性高分子は、天然高分子、半合成高分子、及び合成高分子に分類する ことができ、いずれであってもよい。 [0045] The water-soluble polymer used here is not particularly limited as long as the polymer is soluble in water. Water-soluble polymers are classified into natural polymers, semi-synthetic polymers, and synthetic polymers. Can be any.
[0046] また、水溶性高分子は、電気的性質に応じて、ァ-オン性の水溶性高分子、カチ オン性の水溶性高分子、非イオン性の高分子に層別することもできる。 pHが変化す ることによるゲルィ匕を防止する上では、非イオン性の水溶性高分子の使用が好ましい  [0046] In addition, the water-soluble polymer can be layered into a ionic water-soluble polymer, a cationic water-soluble polymer, and a nonionic polymer according to electrical properties. . Use of nonionic water-soluble polymer is preferable to prevent gelling caused by pH change.
[0047] 水溶性高分子の具体例としては、セルロース系高分子、多糖類系高分子、水溶性 タンパク質、デンプン系高分子、アルギン酸系高分子、アクリル系高分子、ビニル系 高分子、及びグリコール系高分子等が挙げられる。本発明においては、これらの水溶 性高分子力 なる群力も選ばれる少なくとも一種を用いるのが好ましい。 [0047] Specific examples of water-soluble polymers include cellulose polymers, polysaccharide polymers, water-soluble proteins, starch polymers, alginic acid polymers, acrylic polymers, vinyl polymers, and glycols. Based polymers and the like. In the present invention, it is preferable to use at least one selected from these water-soluble polymer forces.
[0048] セルロース系高分子としては、メチルセルロース(非イオン性)、ェチルセルロース( 非イオン性)、カルボキシメチルセルロース(ァ-オン性)、ヒドロキシェチルセルロー ス(非イオン性)、ヒドロキシプロピルセルロース(非イオン性)、ヒドロキシプロピルメチ ルセルロース(非イオン性)、ニトロセルロース(非イオン性)、カチオン化セルロース( カチオン性)等が挙げられる。  [0048] Cellulosic polymers include methylcellulose (nonionic), ethylcellulose (nonionic), carboxymethylcellulose (aion), hydroxyethylcellulose (nonionic), hydroxypropylcellulose ( Nonionic), hydroxypropyl methylcellulose (nonionic), nitrocellulose (nonionic), cationized cellulose (cationic) and the like.
[0049] 多糖類系高分子としては、アラビアガム (ァ-オン性)、カラギーナン (ァ-オン性)、 グァガム(非イオン性)、ローカストビーンガム (非イオン性)、ぺクチン (非イオン性)、 トラガント、トウモロコシデンプン(非イオン性)、キサンタンガム(ァ-オン性)、デキスト リン (非イオン性)、カチオンィ匕グァガム (カチオン性)、ヒアルロン酸ナトリウム(ァ -ォ ン性)、コンドロイチン硫酸ナトリウム A、コンドロイチン硫酸ナトリウム B、コンドロイチン 硫酸ナトリウム C (いずれもァ-オン性)、キトサン、キトサン誘導体、キチン、キチン誘 導体等が挙げられる。  [0049] Polysaccharide polymers include gum arabic (a-on), carrageenan (a-on), guar gum (non-ionic), locust bean gum (non-ionic), pectin (non-ionic) ), Tragacanth, corn starch (non-ionic), xanthan gum (non-ionic), dextrin (non-ionic), cationic guagua gum (cationic), sodium hyaluronate (non-ionic), sodium chondroitin sulfate A, sodium chondroitin sulfate B, sodium chondroitin sulfate C (all of which are on), chitosan, chitosan derivatives, chitin, chitin derivatives and the like.
[0050] 水溶性タンパク質としては、ゼラチン、エラスチン、コラーゲン、 BSA等が挙げられ る。  [0050] Examples of the water-soluble protein include gelatin, elastin, collagen, BSA and the like.
[0051] デンプン系高分子としては、リン酸ィ匕デンプン等が挙げられる。  [0051] Examples of the starch-based polymer include phosphate starch.
[0052] アルギン酸系高分子としては、アルギン酸ナトリウム(ァ-オン性)、アルギン酸プロ ピレンダリコール (非イオン性)等が挙げられる。  [0052] Examples of the alginic acid-based polymer include sodium alginate (a-on type), propylene glycol alginate (nonionic), and the like.
[0053] アクリル系高分子としては、ポリアクリル酸ナトリウム(ァ-オン性)、カルボキシビ- ルポリマー(非イオン性)、ポリアクリル酸アミド (非イオン性)、アクリルアミド'アタリレー ト共重合体 (ァニオン性)等が挙げられる。 [0053] Acrylic polymers include sodium polyacrylate (a-on), carboxyvinyl polymer (non-ionic), polyacrylamide (non-ionic), and acrylamide 'atrely Copolymer (anionic) and the like.
[0054] ビュル系高分子としては、ポリビニルピロリドン(非イオン性)、ポリビュルアルコール  [0054] Examples of the bur polymer include polyvinyl pyrrolidone (nonionic), polybulu alcohol.
(非イオン性)、ビニルピロリドンビニル酢酸共重合体 (PVPZVA共重合体)(非ィォ ン性)等が挙げられる。  (Nonionic), vinylpyrrolidone vinylacetic acid copolymer (PVPZVA copolymer) (nonionic) and the like.
[0055] また、グリコール系高分子としては、ポリエチレングリコール(分子量が 2万〜 500万 のもの)(いずれも非イオン性)、ポリプロピレングリコールとポリエチレングリコールの 共重合体(PEO— PPO— PEO、 Pluronic、 Proxamer)等が挙げられる。  [0055] In addition, glycol polymers include polyethylene glycol (with a molecular weight of 20,000 to 5,000,000) (both are nonionic), a copolymer of polypropylene glycol and polyethylene glycol (PEO—PPO—PEO, Pluronic). , Proxamer) and the like.
[0056] これらの中でも、セルロース系高分子の少なくとも一種を用いるのがより好ましぐヒ ドロキシェチノレセノレロース、ヒドロキシプロピノレセノレロース、ヒドロキシプロピノレメチノレ セルロース等のヒドロキシアルキルセルロースを用いるのが特に好まし 、。  [0056] Among these, it is more preferable to use at least one kind of cellulosic polymer. Hydroxyalkyl celluloses such as hydroxychetinoresenorelose, hydroxypropinoresenorelose, hydroxypropinoremethinocellulose and the like are more preferably used. Is particularly preferred.
[0057] ヒドロキシアルキルセルロースは、公知の方法、例えば、アルカリセルロースに、ェ チレンオキサイドやプロピレンオキサイド等のアルキレンオキサイドを反応させることに より製造することができる。また、市販品として入手したものをそのまま使用することも できる。  [0057] Hydroxyalkyl cellulose can be produced by a known method, for example, by reacting an alkali cellulose with an alkylene oxide such as ethylene oxide or propylene oxide. Moreover, what was acquired as a commercial item can also be used as it is.
[0058] 水溶性高分子の使用量は、用いる水溶性高分子が水に均一に溶解する範囲であ れば、特に制限されない。水溶性高分子の使用量を、用いる水溶性高分子が水に 均一に溶解する範囲内にお 、て増減することにより、得られる粘性液体の粘度を所 望の値にすることができる。水溶性高分子の使用量は、粘性液体全体に対して、通 常 0. 1〜50重量%、好ましくは 1〜: L0重量%、より好ましくは 2〜5重量%である。得 られる粘性液体の粘度は、通常 0. 05Pa' s以上である。  [0058] The amount of the water-soluble polymer to be used is not particularly limited as long as the water-soluble polymer to be used is in a range that can be uniformly dissolved in water. By increasing or decreasing the amount of the water-soluble polymer used within the range in which the water-soluble polymer used is uniformly dissolved in water, the viscosity of the resulting viscous liquid can be brought to a desired value. The amount of the water-soluble polymer used is usually 0.1 to 50% by weight, preferably 1 to L0% by weight, more preferably 2 to 5% by weight, based on the whole viscous liquid. The viscosity of the resulting viscous liquid is usually 0.05 Pa's or more.
[0059] 作用側電極 24における作用側分極性電極 24B及び非作用側電極 44における非 作用側分極性電極 44Bは、共に、活性炭、好ましくは炭素繊維又は炭素繊維紙によ り形成されて!ヽる導電性基材を主成分として構成されて!ヽる。作用側及び非作用側 分極性電極 24B、 44Bとして、活性炭繊維のみを用いる場合は、活性炭繊維からな る布及びフェルトを組み合わせて層を形成すると良い。又、導電性基材に対して、例 えばバインダーポリマー中に活性炭を分散させた層を積層させても良 ヽ。上記活性 炭は比表面積が 10m2Zg以上のものを用いてもょ 、。 [0059] The working-side polarizable electrode 24B in the working-side electrode 24 and the non-working-side polarizable electrode 44B in the non-working-side electrode 44 are both formed of activated carbon, preferably carbon fiber or carbon fiber paper! It is composed mainly of a conductive base material. When only the activated carbon fiber is used as the working and non-working polarizable electrodes 24B and 44B, the layer may be formed by combining cloth and felt made of activated carbon fiber. For example, a layer in which activated carbon is dispersed in a binder polymer may be laminated on the conductive substrate. The activated charcoal may have a specific surface area of 10m 2 Zg or more.
[0060] 作用側分極性電極 24Bには、薬液保持部 30に保持されている薬物と同一の薬物 を含む粘性液体が含浸され、又、非作用側分極性電極 44Bには、電極側電解液保 持部 46に保持される電解液と同一の電解液を含む粘性液体が含浸されて 、る。 [0060] The working side polarizable electrode 24B has the same drug as the drug held in the drug solution holding unit 30. In addition, the non-working-side polarizable electrode 44B is impregnated with a viscous liquid containing the same electrolytic solution as the electrolytic solution held in the electrode-side electrolytic solution holding part 46.
[0061] 作用側電極 24における作用側集電体 24A及び非作用側電極 44における非作用 側集電体 44Aは、共に、 PET (ポリエチレンテレフタレート)素材に炭素と接着剤とを 混ぜたものを印刷して形成されて 、る。  [0061] Both the working side current collector 24A in the working side electrode 24 and the non-working side current collector 44A in the non-working side electrode 44 are printed by mixing a PET (polyethylene terephthalate) material with carbon and an adhesive. Formed.
[0062] なお、作用側集電体 24A、非作用側集電体 44Aの材料としては導電性を有するも のであればよぐ炭素以外に、金、白金、銀、銅、亜鉛等の導電性の金属を用いても 良い。又、印刷によることなぐ炭素、金等の導電性素材そのものを集電体としても良 い。又、作用側導線 19A、非作用側導線 19Bの材料についても同様である。  [0062] The working current collector 24A and the non-working current collector 44A may be made of conductive materials such as gold, platinum, silver, copper, and zinc, in addition to carbon as long as they have conductivity. Other metals may be used. In addition, a conductive material itself such as carbon or gold that is printed can be used as the current collector. The same applies to the material of the working conductor 19A and the non-working conductor 19B.
[0063] セパレータ 26は、 PP不織布に、薬液保持部 30に保持された薬物と同一の薬物を 含有する粘性液体を含浸させたものであり、作用側分極性電極 24Bと中間イオン選 択性膜 28との間に介在させることによって、両者の物理的な接触を防止するもので ある。  [0063] The separator 26 is obtained by impregnating a PP non-woven fabric with a viscous liquid containing the same drug as the drug held in the drug solution holding unit 30, and includes the working side polarizable electrode 24B and the intermediate ion selective membrane. By interposing between the two, physical contact between the two is prevented.
[0064] 作用側イオン選択性膜 32は、薬物イオンと同一符号のイオンを選択的に通過させ るようにイオン交換基が導入されたイオン交換榭脂を含んで構成されて ヽる。即ち、 作用側イオン選択性膜 32は、薬液保持部 30の薬液力 Sカチオンに解離するときは陽 イオン交換榭脂を含み、ァ-オンに解離するときは陰イオン交換榭脂を含んで ヽる。  [0064] The working-side ion-selective membrane 32 is configured to include an ion-exchange resin into which an ion-exchange group has been introduced so that ions having the same sign as drug ions can be selectively passed therethrough. That is, the working side ion-selective membrane 32 contains a cation exchange resin when dissociating into a chemical force S cation of the chemical solution holding unit 30, and contains an anion exchange resin when dissociating into a cation. The
[0065] 中間イオン選択性膜 28は、薬物イオンと反対符号のイオンを選択的に通過させる ようにイオン交換基が導入されたイオン交換榭脂を含有して構成されて ヽる。即ち、 中間イオン選択性膜 28は、薬液保持部 30の薬液力 Sカチオンに解離するときは陰ィ オン交換榭脂を含み、ァ-オンに解離するときは陽イオン交換榭脂を含んで ヽる。  The intermediate ion selective membrane 28 is configured to contain an ion exchange resin into which an ion exchange group has been introduced so as to selectively pass ions having the opposite signs to the drug ions. That is, the intermediate ion-selective membrane 28 contains anion exchange resin when dissociating into the chemical force S cation of the chemical solution holding unit 30, and contains cation exchange resin when dissociating into the cation. The
[0066] 非作用側イオン選択性膜 50は、中間イオン選択性膜 28と同様に、薬物イオンと反 対符号のイオンを選択的に通過させるようにイオン交換基が導入されたイオン交換 榭脂を含んで構成されている。即ち、非作用側イオン選択性膜 50は、薬液保持部 3 0の薬液力 Sカチオンに解離するときは陰イオン交換榭脂を含み、ァ-オンに解離する ときは陽イオン交換榭脂を含んで 、る。  [0066] Similar to the intermediate ion-selective membrane 28, the non-working side ion-selective membrane 50 is an ion-exchange resin in which an ion-exchange group has been introduced so as to selectively pass drug ions and ions having opposite signs. It is comprised including. That is, the non-working side ion selective membrane 50 contains an anion exchange resin when dissociating into the chemical force S cation of the chemical solution holding unit 30 and contains a cation exchange resin when dissociating into the cation. Out.
[0067] 上記陽イオン交換榭脂としては、ポリスチレン榭脂ゃアクリル酸系榭脂等の炭化水 素系榭脂ゃパーフルォロカーボン骨格を有するフッ素系榭脂等の 3次元的な網目構 造を持つ高分子に、スルホン酸基、カルボン酸基、ホスホン酸基等の陽イオン交換基 (対イオンが陽イオンである交換基)が導入されたイオン交換樹脂が制限無く使用す ることがでさる。 [0067] Examples of the cation exchange resin include a three-dimensional network structure such as a polystyrene resin, a fluorocarbon resin having a perfluorocarbon skeleton, such as a hydrocarbon resin such as an acrylic resin. An ion exchange resin in which a cation exchange group (an exchange group in which the counter ion is a cation) such as a sulfonic acid group, a carboxylic acid group, or a phosphonic acid group is introduced into a polymer having a structure may be used without limitation. I'll do it.
[0068] 又、上記陰イオン交換榭脂としては、陽イオン交換樹脂と同様の 3次元的な網目構 造を持つ高分子に、 1〜3級ァミノ基、 4級アンモ-ゥム基、ピルジル基、イミダゾール 基、 4級ピリジゥム基、 4級イミダゾリゥム基等の陽イオン交換基 (対イオンが陰イオン である交換基)が導入されたイオン交換樹脂が制限無く使用できる。  [0068] In addition, as the anion exchange resin, a polymer having a three-dimensional network structure similar to that of the cation exchange resin may be added to primary to tertiary amine groups, quaternary ammonia groups, and pyrzyl. An ion exchange resin into which a cation exchange group (an exchange group in which the counter ion is an anion) such as a group, an imidazole group, a quaternary pyridinium group, or a quaternary imidazolium group can be used without limitation.
[0069] イオントフォレーシスシステムの糸且立時には、図 1あるいは図 4に示される状態で、 各構成部材を配置して積層し、あるいは、貫通孔に収納し、基端支持体 14、中間支 持体 16、先端支持体 18を順次重ねて、これらを粘着層 16A、 14Aにより粘着して固 定し、更に、リリースライナー 58を先端支持体 18に貼り付けて組立を完了する。  [0069] When the iontophoresis system is threaded, in the state shown in Fig. 1 or Fig. 4, the constituent members are arranged and stacked, or are stored in the through-holes, and the proximal support 14, intermediate The support body 16 and the tip support body 18 are sequentially stacked, and these are adhered and fixed by the adhesive layers 16A and 14A. Further, the release liner 58 is attached to the tip support body 18 to complete the assembly.
[0070] 直流電源 12としては、ボタン電池、あるいは、例えば特開平 11 067236号公報、 米国特許公開公報 2004Z0185667A1号公報、米国特許第 6855441号公報等 に開示される薄型の電池を使用することができ、本実施形態の構造に限定されるも のでない。  [0070] As the DC power source 12, a button battery or a thin battery disclosed in, for example, Japanese Patent Application Laid-Open No. 11 067236, US Patent Publication No. 2004Z0185667A1, US Patent No. 6855441, or the like can be used. It is not limited to the structure of this embodiment.
[0071] 次に、イオントフォレーシスによって投与すべき薬物を塩酸リドカインとした場合のィ オントフォレーシスシステムにおける各構成部分の具体例について説明する。  [0071] Next, specific examples of each component in the iontophoresis system when the drug to be administered by iontophoresis is lidocaine hydrochloride will be described.
[0072] 基端支持体 14、中間支持体 16、先端支持体 18は、それぞれ厚さ約 lmmの発泡 ポリウレタンシートを用いた。  [0072] For the base end support 14, the intermediate support 16, and the front support 18, foamed polyurethane sheets each having a thickness of about 1 mm were used.
[0073] 作用側集電体 24A及び非作用側集電体 44Aは PET素材に炭素と接着剤を混ぜ たものを印刷した印刷電極とした。又、直径 17mmの円形で、厚さ 1. Ommの活性炭 繊維カゝらなる活性炭繊維層を構成した。この活性炭繊維層に水と HPC及び塩酸リド 力インを混合した粘性液体を含浸させて作用側分極性電極 24Bとした。又、活性炭 繊維層に、水と HPC及び NaClを混合した粘性液体を含浸させて非作用側分極性 電極 44Bを構成した。各々の重量は 120〜125mgとした。  [0073] The working current collector 24A and the non-working current collector 44A were printed electrodes on which a PET material mixed with carbon and an adhesive was printed. In addition, an activated carbon fiber layer composed of a circular carbon having a diameter of 17 mm and a thickness of 1. Omm was formed. The activated carbon fiber layer was impregnated with a viscous liquid in which water, HPC, and hydrochloric acid were mixed to form a working side polarizable electrode 24B. In addition, the activated carbon fiber layer was impregnated with a viscous liquid in which water, HPC, and NaCl were mixed to form the non-working side polarizable electrode 44B. The weight of each was 120-125 mg.
[0074] セパレータ 26は、直径 18mm、厚さ 0. lmmの PP不織布から構成して、水に HPC 及び塩酸リドカインを混合した粘性液体を含浸させた。中間イオン選択性膜 28は、 直径 21mm、厚さ 30 mのァ-オン交換膜とした。 [0075] 薬液保持部 30は、厚さ 1. Omm、直径 17mmの PP不織布に水と HPC及び塩酸リ ドカインを混合した粘性液体を含浸させたものであり、重量は 250〜320mgとした。 [0074] The separator 26 was composed of a PP nonwoven fabric having a diameter of 18 mm and a thickness of 0.1 mm, and was impregnated with a viscous liquid obtained by mixing HPC and lidocaine hydrochloride in water. The intermediate ion selective membrane 28 was a key-on exchange membrane having a diameter of 21 mm and a thickness of 30 m. [0075] The chemical solution holding unit 30 was obtained by impregnating a PP nonwoven fabric having a thickness of 1. Omm and a diameter of 17 mm with a viscous liquid obtained by mixing water, HPC, and lidocaine hydrochloride, and the weight was 250 to 320 mg.
[0076] 作用側イオン選択性膜 32は、厚さ 30 μ m、直径 19mmのカチオン交換膜とした。  The working ion selective membrane 32 was a cation exchange membrane having a thickness of 30 μm and a diameter of 19 mm.
この作用側イオン選択性膜 32の面積は、電流値を考慮して決定する。例えば電流 値が 1mAの場合は、直径 19mmで、電流密度が 0. 35mAZcm2となる。ここでは、 薬効のあるカチオン (リド力イン)をイオン交換基に置換しておく。 The area of the working ion selective membrane 32 is determined in consideration of the current value. For example, if the current value is 1 mA, a diameter 19 mm, the current density is 0. 35mAZcm 2. Here, a medicinal cation (lid power in) is substituted with an ion exchange group.
[0077] 非作用側電極構造体 40における電極側電解液保持部 46は、非作用側分極性電 極 44Bで用いたと同一の NaClを含有する粘性液体を PP不織布に含浸した構成とし 、直径 18mm、厚さ 100 mとした。又、先端側電解液保持部 48は、直径が 17mm 、厚さ lmmの PP不織布に前記と同様の粘性液体を含浸させたものであり、重量は 2 50〜320mgとした。又、非作用側イオン選択性膜 50は、厚さ 30 m、直径 21mmと し、塩ィ匕物イオンをイオン交換基に置換されたァ-オン交換膜とした。  [0077] The electrode-side electrolyte holding part 46 in the non-working-side electrode structure 40 has a configuration in which a PP non-woven fabric is impregnated with the same viscous liquid containing NaCl as that used in the non-working-side polarizable electrode 44B, and has a diameter of 18 mm. The thickness was 100 m. Further, the tip side electrolyte solution holding part 48 is obtained by impregnating a PP non-woven fabric having a diameter of 17 mm and a thickness of 1 mm with the same viscous liquid as described above, and the weight is 250 to 320 mg. The non-acting side ion selective membrane 50 is a key-on exchange membrane having a thickness of 30 m and a diameter of 21 mm, in which chloride ions are substituted with ion exchange groups.
[0078] 本実施形態のイオントフォレーシスシステムにおいては、リリースライナー 58の凹部 60、 62内に設けられたスポンジ 64、 66に粘性液体 70が保持されているので、粘性 液体 70を容易にイオン選択性膜 32、 50に付着させることができる。従って、イオント フォレーシス装置 10を生体の皮膚に装着する際には、リリースライナー 58を剥がすこ とによって、図 7に示す如ぐイオン選択性膜 32、 50と皮膚の間に、粘性液体 70でな る生体接触部 72が形成される。よって、イオン選択性膜に粘性液体を付着させてリリ ースライナーを貼り付けるのと比較すると、簡易に粘性液体を付着させることができる  In the iontophoresis system of the present embodiment, the viscous liquid 70 is held in the sponges 64 and 66 provided in the recesses 60 and 62 of the release liner 58, so that the viscous liquid 70 is easily ionized. It can be attached to the selective membrane 32, 50. Therefore, when the iontophoresis device 10 is attached to the skin of a living body, the release liner 58 is peeled off so that a viscous liquid 70 is not formed between the ion selective membranes 32 and 50 and the skin as shown in FIG. A living body contact portion 72 is formed. Therefore, it is possible to easily attach a viscous liquid as compared with attaching a release liner by attaching a viscous liquid to an ion selective membrane.
[0079] この粘性液体 70により皮膚とイオン選択性膜 32、 50の密着性が向上し、イオン選 択性膜の性能を発揮でき、薬物保持部 30中の薬物イオンを十分に皮膚に送達する ことができる。 [0079] The viscous liquid 70 improves the adhesion between the skin and the ion-selective membranes 32 and 50, can exhibit the performance of the ion-selective membrane, and sufficiently delivers the drug ions in the drug holding unit 30 to the skin. be able to.
[0080] また、スポンジに浸み込ませる粘性液体 70の量を調節することによって、イオン選 択性膜 32、 50に付着する粘性液体 70の量を調節することができる。  [0080] Further, the amount of the viscous liquid 70 adhering to the ion selective membranes 32 and 50 can be adjusted by adjusting the amount of the viscous liquid 70 to be immersed in the sponge.
[0081] なお、粘性液体 70を介在させる方法は、前記実施形態に限定されず、 Vヽずれか一 方のスポンジ 64、 66を省略することもできる。又、生体への装着直前にリリースライナ 一 58でイオントフォレーシス装置 10の装着面側をカバーして、粘性液体 70をイオン トフォレーシス装置 10の装着面に付けた状態でイオントフォレーシス装置 10を皮膚 に装着して、生体接触部 72を形成することもできる。 [0081] Note that the method of interposing the viscous liquid 70 is not limited to the above-described embodiment, and the V-deviation or one of the sponges 64, 66 can be omitted. Also, immediately before mounting on the living body, the mounting surface side of the iontophoresis device 10 is covered with the release liner 58, and the viscous liquid 70 is ionized. The biological contact portion 72 can also be formed by attaching the iontophoresis device 10 to the skin in a state of being attached to the attachment surface of the tophoresis device 10.
[0082] 本実施形態においては、粘性液体 70を連続発泡体であるスポンジ 64、 66に浸み 込ませてリリースライナー 58でカバーしているので、残る量を制御できると共に保存 中の乾燥を防止できる。又、スポンジ 64、 66を凹部 60、 62内に収納しているので、 粘性液体 70が広がりすぎるのを防止でき、所望量の面積当りの粘性液体量を確保 できる。更に、不要な所に付着したりせず、取扱いが簡易である。  [0082] In this embodiment, the viscous liquid 70 is soaked in the sponges 64 and 66, which are continuous foams, and covered with the release liner 58, so that the remaining amount can be controlled and drying during storage is prevented. it can. Further, since the sponges 64 and 66 are accommodated in the recesses 60 and 62, the viscous liquid 70 can be prevented from spreading too much, and a desired amount of viscous liquid per area can be secured. Furthermore, it does not adhere to unnecessary places and is easy to handle.
[0083] なお、上記作用側電極構造体 20において、セパレータ 26が設けられている力 こ れは、作用側分極性電極 24Bと中間イオン選択性膜 28との直接的な接触を防止し、 通電時に中間イオン選択性膜 28の近傍において塩素ガスなどの気泡が発生し、こ れにより電極構造体内における通電性が損なわれることを防止するためのものであり 、他の手段によって直接接触を防止できる場合は不要である。また、作用側分極性 電極 24Bと中間イオン選択性膜 28とが直接的に接触したとしても、通電時に中間ィ オン選択性膜 28の近傍にぉ 、て塩素ガスなどの気泡が発生しな 、場合には、セパ レータ 26などの両者の直接接触を防止するための手段は不要である。  [0083] In the working electrode structure 20, the force provided with the separator 26 prevents direct contact between the working polarizable electrode 24B and the intermediate ion-selective membrane 28. This is to prevent the occurrence of bubbles such as chlorine gas in the vicinity of the intermediate ion-selective membrane 28 and thereby impair the conductivity in the electrode structure, and direct contact can be prevented by other means. The case is not necessary. Even if the working side polarizable electrode 24B and the intermediate ion selective membrane 28 are in direct contact with each other, bubbles such as chlorine gas are not generated near the intermediate ion selective membrane 28 when energized. In some cases, no means for preventing direct contact between the two, such as separator 26, is required.
[0084] 又、電極側電解液保持部 46と先端側電解液保持部 48とは、 PP不織布に、電解液 を含む粘性液体を含浸させた構成にぉ ヽて共通であるので、一体的に構成しても良 い。  [0084] Further, the electrode side electrolyte solution holding part 46 and the tip side electrolyte solution holding part 48 are common to the configuration in which a PP nonwoven fabric is impregnated with a viscous liquid containing an electrolyte solution. May be configured.
産業上の利用の可能性  Industrial applicability
[0085] 本発明は、薬物イオンを、電圧を印加することによって生体に投与するためのィォ ントフォレーシス装置を備えたィ才ントフォレーシスシステム、特に、生体の皮膚とィ才 ントフォレーシス装置のイオン選択性膜の密着性を簡単に高めて、薬物イオンをむら なく送達することが可能なイオントフォレーシスシステムを提供することができる。 [0085] The present invention relates to a tomatophoresis system comprising an iontophoresis device for administering drug ions to a living body by applying a voltage, and more particularly, to the skin of an organism and the iontophoresis device ion. It is possible to provide an iontophoresis system that can easily improve the adhesion of a selective membrane and deliver drug ions evenly.

Claims

請求の範囲 The scope of the claims
[1] 直流電源と、この直流電源の陽極及び陰極の一方に接続された作用側電極構造 体及び他方に接続された非作用側電極構造体とから構成され、前記作用側電極構 造体に保持される薬物イオンを、前記直流電源力 の電圧によって生体に投与する ためのイオントフォレーシス装置であって、  [1] A direct-current power source, and a working-side electrode structure connected to one of an anode and a cathode of the direct-current power source and a non-working-side electrode structure connected to the other, the working-side electrode structure being An iontophoresis device for administering retained drug ions to a living body by the voltage of the DC power supply,
前記作用側電極構造体は、  The working electrode structure is
前記薬物イオンと同種の極性の、前記陽極又は陰極に接続された作用側電極と、 この作用側電極と電気的に接続され、前記薬物イオンとなる薬物を保持する薬液 保持部と、  A working electrode connected to the anode or cathode of the same polarity as the drug ion; a drug solution holding unit that is electrically connected to the working electrode and holds the drug that becomes the drug ion;
前記薬液保持部と電気的に接続され、前記薬物イオンと同種のイオンを選択的に 通過させる作用側イオン選択性膜と、  An active ion-selective membrane that is electrically connected to the drug solution holding unit and selectively allows the same kind of ions as the drug ions to pass through;
を少なくとも有してなるイオントフォレーシス装置と、  An iontophoresis device comprising at least
該イオントフォレーシス装置の作用側イオン選択性膜の生体側をカバーするための 、粘性液体保持部が設けられたリリースライナーと、  A release liner provided with a viscous liquid holding portion for covering the living body side of the working ion selective membrane of the iontophoresis device;
を備えたことを特徴とするイオントフォレーシスシステム。  An iontophoresis system characterized by comprising:
[2] 直流電源と、この直流電源の陽極及び陰極の一方に接続された作用側電極構造 体及び他方に接続された非作用側電極構造体とから構成され、前記作用側電極構 造体に保持される薬物イオンを、前記直流電源力 の電圧によって生体に投与する ためのイオントフォレーシス装置であって、  [2] A direct-current power source, and a working-side electrode structure connected to one of the anode and the cathode of the direct-current power source and a non-working-side electrode structure connected to the other, the working-side electrode structure being An iontophoresis device for administering retained drug ions to a living body by the voltage of the DC power supply,
前記非作用側電極構造体は、  The non-working side electrode structure is
前記薬物イオンと反対の極性の、前記陽極又は陰極に接続された非作用側電極と この作用側電極と電気的に接続され、電解液を保持する電解液保持部と、 この電解液保持部と電気的に接続され、前記薬物イオンと反対のイオンを選択的 に通過させる非作用側イオン選択性膜と、  A non-working side electrode connected to the anode or cathode and having a polarity opposite to that of the drug ion; an electrolytic solution holding unit that is electrically connected to the working side electrode and holds an electrolytic solution; and the electrolytic solution holding unit; A non-acting ion-selective membrane that is electrically connected and selectively passes ions opposite to the drug ions;
を少なくとも有してなるイオントフォレーシス装置と、  An iontophoresis device comprising at least
該イオントフォレーシス装置の非作用側イオン選択性膜の生体側をカバーするため の、粘性液体保持部が設けられたリリースライナーと、 を備えたことを特徴とするイオントフォレーシスシステム。 A release liner provided with a viscous liquid holding part for covering the living body side of the non-working side ion selective membrane of the iontophoresis device; An iontophoresis system characterized by comprising:
[3] 前記粘性液体保持部が、リリースライナーの凹部に配設された連続発泡体を含む ことを特徴とする請求項 1又は 2に記載のイオントフォレーシスシステム。  [3] The iontophoresis system according to [1] or [2], wherein the viscous liquid holding portion includes a continuous foam disposed in a recess of a release liner.
[4] 前記粘性液体が、水に水溶性高分子を混合したものであることを特徴とする請求項[4] The viscous liquid is a mixture of water and a water-soluble polymer.
1乃至 3のいずれかに記載のイオントフォレーシスシステム。 The iontophoresis system according to any one of 1 to 3.
[5] 前記粘性液体に、薬物保持部の薬物と同じ薬物又は電解液保持部の電解液と同 じ電解液が含められていることを特徴とする請求項 1乃至 4のいずれかに記載のィォ ントフォレーシスシステム。 [5] The liquid according to any one of claims 1 to 4, wherein the viscous liquid contains the same drug as the drug in the drug holding unit or the same electrolytic solution as the electrolytic solution in the electrolyte holding unit. An ion foresis system.
PCT/JP2007/058362 2006-04-18 2007-04-17 Iontophoresis system WO2007123131A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003037425A1 (en) * 2001-10-31 2003-05-08 R & R Ventures Incorporation Iontophoresis device
JP2005319288A (en) * 2004-04-07 2005-11-17 Vyteris Inc Electrically assisted lidocaine and epinephrine delivery device having improvement in shelf-stability

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003037425A1 (en) * 2001-10-31 2003-05-08 R & R Ventures Incorporation Iontophoresis device
JP2005319288A (en) * 2004-04-07 2005-11-17 Vyteris Inc Electrically assisted lidocaine and epinephrine delivery device having improvement in shelf-stability

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