JP2007061274A - Iontophoresis apparatus equipped with system for stopping administration by information on side effects from sensor - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an iontophoresis apparatus equipped with a system which suspends medicament releasing based on information about side effects comprising allergic reaction from a sensor installed in a living body. <P>SOLUTION: In the iontophoresis apparatus 14 equipped with a power source device, the first electrode structure for emitting an ionic medicament by iontophoresis to percutaneously administer to the living body, and the second electrode structure as the counter electrode of this first electrode structure, the sensor 10 is formed in the living body 6 which is the subject for administering the medicament, particular components in the body, which participate in the side effects, are monitored by this sensor 10, and the medicament releasing is suspended by actuating the power source device based on detection information from the sensor 10. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a technique (transdermal drug delivery) for transdermally administering various ionic drugs by iontophoresis, and particularly to information on side effects including allergic reactions from sensors installed in living bodies. The present invention relates to an iontophoresis device having a system for stopping drug release based on the above.

  An ionic drug placed on the surface of the skin or mucous membrane (hereinafter simply referred to as “skin”) at a predetermined part of the living body is given an electromotive force to drive the ionic drug to the skin, and the drug is passed through the skin. The method of introducing (penetrating) into the body is called iontophoresis (iontophoresis, iontophoresis, iontophoresis) (see Patent Document 1, etc.).

  For example, positively charged ions are driven (transported) into the skin on the anode side of the electrical system of the iontophoresis device. On the other hand, ions having a negative charge are driven (transported) into the skin on the cathode side of the electrical system of the iontophoresis device.

  Many proposals have been made for iontophoresis devices as described above (see, for example, Patent Documents 1 to 7).

  In the conventional iontophoresis device as described above, whether to start / continue or stop the administration of a drug to be administered to a living body is generally determined according to an instruction based on a prescription or a judgment of a medical practitioner. Has been done.

  However, when specific components related to side effects are generated in the body due to drug administration, and when side effects such as allergic reactions or symptoms begin to appear, it is not always the same. / There is a limit to doing this by judging the stop only artificially.

  Therefore, it is important in order to prevent the occurrence of side effects and prevent medical accidents in advance to quickly detect the side effects including allergic reactions and the signs thereof before they occur.

It is also difficult to artificially determine the signs of side effects and control the continuation or suspension of drug administration, especially when sleeping or when it is necessary to administer the drug by iontophoresis for a long time. In some cases, it is also important to respond quickly and appropriately to changes in the internal state of the body.
JP 63-35266 JP-A-4-297277 JP 2000-229128 A JP 2000-229129 A JP 2000-237327 A JP 2000-237328 A International Publication WO03 / 037425A1

  The present invention has been made in view of the above-described problems of the prior art, and includes an iontophoresis system including a system for stopping drug release based on information on side effects including allergic reactions from sensors installed in a living body. The object is to provide a cis apparatus.

  In order to solve the above-mentioned problems, an iontophoresis device according to the present invention includes a power supply device and a ionic drug connected to the power supply device by iontophoresis and transdermally administered to a living body. In an iontophoresis device including a first electrode structure for performing a treatment and a second electrode structure as a counter electrode of the first electrode structure, a sensor is provided on a living body to which a drug is to be administered. The specific component in the body involved in the side effect is monitored by this sensor, and the drug release is stopped by driving the power supply device based on the detection information from the sensor.

  In a preferred aspect of the present invention, the first electrode structure includes a first electrode connected to a power supply device having the same polarity as the drug component of the ionic drug, and an electrolysis disposed adjacent to the first electrode. A first electrolyte holding part that impregnates and holds the liquid; an ion exchange membrane that selects ions opposite to the charged ions of the ionic drug disposed adjacent to the first electrolyte holding part; and A drug holding unit that impregnates and holds an ionic drug arranged adjacently, and an ion exchange membrane that selects ions of the same kind as the charged ions of the ionic drug arranged adjacent to the drug holding unit, The second electrode structure includes a second electrode having a polarity opposite to that of the first electrode of the first electrode structure, and a second electrolyte solution holding unit that impregnates and holds the electrolyte solution disposed adjacent to the second electrode. And disposed adjacent to the second electrolyte solution holding part. Consisting of an ion exchange membrane for selecting the opposite ions and charged ions of the ionic drug.

  As described above, in the iontophoresis device according to the present invention, the specific component in the body involved in the side effect is monitored, and the drug release is stopped based on the detection information. Therefore, the side effect caused by the drug administration occurs. Can be prevented in advance.

  As described above, an iontophoresis device according to the present invention includes a power supply device and a first device connected to the power supply device for releasing an ionic drug by iontophoresis and transdermally administering it to a living body. In an iontophoresis device including an electrode structure and a second electrode structure as a counter electrode of the first electrode structure, a sensor is provided in a living body to which a drug is to be administered. A specific component in the body involved in the monitoring is monitored, and the drug release is stopped by driving the power supply device based on detection information from the sensor.

  Hereinafter, the present invention will be described based on preferred specific examples illustrated in the drawings. The embodiment shown in FIG. 1 shows a state in which an iontophoresis device according to the present invention is arranged on the surface of the skin 6, and a first electrode structure connected to the power supply device 1 and the power supply device 2. A body 2 and a second electrode structure 3 are provided. Furthermore, in the iontophoresis device of the present invention, the sensor 4 is installed at a specific part of the living body. This sensor 4 is a sensor that monitors a specific component in the body involved in side effects caused by drug administration, and information from this sensor 4 is subjected to predetermined processing in the control circuit unit 5 and fed back to the power supply device 1. The on / off operation of the first and second electrode structures is controlled.

  Physiological mechanisms that cause side effects such as allergic reactions and the mechanism of production of allergen substances in the body are complex and there are still many unknown parts. It is said to be caused by the release of substances such as locotoluene and SRS, or the secretion of acetylcholine which is a parasympathetic nerve transmitter.

  Therefore, in this specific example, for example, by detecting the antibody titer by the sensor 4, or by detecting the presence of components in the body involved in side effects such as histamine and acetylcholine in the blood, or the concentration of these components, The detection information is detected in advance, and the detection information is fed back to the control circuit unit 5 to stop the drug release from the electrode structure by the above process.

  As a sensor that can be used in such a device, a known chemical sensor can be appropriately used according to the target component. In addition, a biosensor including a substrate recognition unit such as an enzyme and a signal conversion unit (transducer) that converts a change in physical properties caused by recognition of a target substrate into an electrical signal can be used. Furthermore, an activity-inhibiting biosensor suitable for measuring harmful substances in the body can also be used. This activity-inhibiting biosensor detects and measures the inhibitory action of a specific substance on enzyme activity.

  FIG. 2 is a block diagram specifically illustrating a process in which on / off control (operation for stopping drug release) is automatically performed based on side effect information from the sensor as described above. As shown in the figure, the detection information regarding the side effect from the sensor 10 is the on / off information obtained by comparing preset values of detection component information (for example, antibody titer and histamine concentration) in the identification / collation circuit 12. Is generated, and this information is sent to the iontophoresis control power supply unit 13 to control on / off of the iontophoresis device 14 (trigger control).

  In a preferred embodiment of the iontophoresis device of the present invention, the first electrode structure 3 includes a first electrode connected to a power supply device having the same polarity as the drug component of the ionic drug, and the first electrode plate. A first electrolyte holding unit that impregnates and holds the electrolyte solution disposed adjacent to the first electrolyte solution, and an ion exchange membrane that selects ions opposite to the charged ions of the ionic drug disposed adjacent to the first electrolyte solution holding unit And an ion exchange that selects an ion of the same type as the charged ion of the ionic drug placed adjacent to the drug holding part, and a drug holding part that impregnates and holds the ionic drug placed adjacent to the ion exchange membrane And a membrane. The details of the iontophoresis device including such an electrode structure are described in the above-mentioned International Publication WO03 / 037425A1 (Patent Document 7) relating to the present applicant.

  In a general iontophoresis device, the first electrode structure constitutes a working electrode structure, and the second electrode structure constitutes a non-working electrode structure (ground electrode structure). However, depending on the mode, it may be configured such that the drug can be released in both electrode structures, and the present invention includes such mode.

  As the electrode of the electrode structure, for example, an inert electrode made of a conductive material such as carbon or platinum can be preferably used. Further, the electrolytic solution holding part can be constituted by a thin film body having a characteristic of impregnating and holding the electrolytic solution. In addition, this thin film body can use the same kind as the material used for the chemical | medical agent holding | maintenance part for impregnating and holding the ionic chemical | medical agent mentioned later.

  As the electrolytic solution, a desired one can be used as appropriate according to the conditions of the applied drug and the like, but those that damage the skin of the living body due to electrode reactions should be avoided. As an electrolytic solution suitable for the present invention, an organic acid or salt thereof present in a metabolic circuit of a living body is preferable from the viewpoint of harmlessness. For example, lactic acid, fumaric acid and the like are preferable. Specifically, an aqueous solution of 1M lactic acid and 1M sodium fumarate in a 1: 1 ratio is preferable. Such an electrolytic solution is preferable because it has a high solubility in water and conducts current well, and when a current is passed at a constant current, the electrical resistance is low and the pH change in the power supply device is relatively small.

Moreover, as an ion exchange membrane used for an electrode structure, it is preferable to use a cation exchange membrane and an anion exchange membrane together. Further, the drug holding unit is configured by a thin film body that is impregnated and held with an ionic drug. Such a thin film body has sufficient ability to impregnate and hold an ionic drug, and has the ability to transfer the ionic drug impregnated and held under a predetermined electric field (electric field) condition to the skin side (ion transferability). It is important that the ionic conductivity is sufficient. Usually, the following conditions are employed as operating conditions in the iontophoresis device having the above-described configuration.
(1) constant current conditions, specifically 0.1~0.5mA / cm ^2, preferably 0.1~0.3mA / ^cm 2,
(2) Realizing the above constant current and safe voltage conditions, specifically 50 V or less, preferably 30 V or less,
This is the condition.

  Materials having both good impregnation retention characteristics and good ion transportability under the above conditions include acrylic resin hydrogel bodies (acrylic hydrogel films), segmented polyurethane gel films, or gel-like solid electrolytes. Examples thereof include an ion conductive porous sheet for formation.

  Specific examples of ionic drugs applied to iontophoresis are appropriately selected according to the intended use such as anesthetics (procaine hydrochloride, lidocaine hydrochloride, etc.) in addition to drugs such as insulin and antihypertensive agents as described above. Is done.

  Details of each of the constituent materials and operating conditions as described above are described in Patent Document 7 related to the present applicant, and the present invention includes the contents described in this document.

The figure which shows the outline | summary of the iontophoresis apparatus which concerns on this invention. The conceptual diagram which shows the process of on-off control by the iontophoresis apparatus which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Power supply device 2 1st electrode structure 3 2nd electrode structure 4 Sensor 5 Control circuit part 6 Skin (body surface)

Claims (3)

A power supply device, a first electrode structure connected to the power supply device for transdermally administering an ionic drug to a living body by iontophoresis, and a counter electrode of the first electrode structure In an iontophoresis device comprising the second electrode structure of
A sensor is provided in a living body to which a drug is to be administered, a specific component in the body that is involved in side effects is monitored by this sensor, and drug release is stopped by driving the power supply device based on detection information from the sensor An iontophoresis device characterized in that: A first electrolysis in which the first electrode structure is impregnated and held with a first electrode connected to a power supply device having the same polarity as the drug component of the ionic drug and an electrolyte disposed adjacent to the first electrode. A liquid holding unit, an ion exchange membrane for selecting ions opposite to the charged ions of the ionic drug arranged adjacent to the first electrolyte holding unit, and an ionicity arranged adjacent to the ion exchange membrane A drug holding unit impregnating and holding the drug, and an ion exchange membrane for selecting ions of the same type as the charged ions of the ionic drug arranged adjacent to the drug holding unit,
The second electrode structure is impregnated and held with a second electrode having a polarity opposite to the first electrode of the first electrode structure and an electrolyte disposed adjacent to the second electrode. The iontophoresis device according to claim 1, comprising an ion exchange membrane that selects an ion opposite to a charged ion of an ionic drug disposed adjacent to the second electrolyte solution holding unit.   The iontophoresis device according to claim 1, wherein the sensor is a sensor that detects a component involved in an allergic reaction caused by a drug to be administered.

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