JP4312085B2 - イオン性薬剤投与用の貼付材 - Google Patents
イオン性薬剤投与用の貼付材 Download PDFInfo
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- JP4312085B2 JP4312085B2 JP2004064910A JP2004064910A JP4312085B2 JP 4312085 B2 JP4312085 B2 JP 4312085B2 JP 2004064910 A JP2004064910 A JP 2004064910A JP 2004064910 A JP2004064910 A JP 2004064910A JP 4312085 B2 JP4312085 B2 JP 4312085B2
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- JP
- Japan
- Prior art keywords
- ion exchange
- exchange membrane
- drug
- living body
- membrane
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Fee Related
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Images
Landscapes
- Medicinal Preparation (AREA)
Description
イオン交換膜を1mol/LのHCl水溶液に10時間以上浸漬した。
含水率=100×(W−D)/D[%]
固定イオン濃度=100×イオン交換容量/含水率[mmol/g−水]
(2)膜抵抗;
セルの内部をイオン交換膜で仕切って形成した2室のそれぞれに白金黒電極を設けた構造の2室セルを用意した。イオン交換膜の両側の各室に3mol/lの硫酸水溶液を満たした。交流ブリッジ(周波数1000サイクル/秒)により25℃における電極間の抵抗を測定した。該電極間の抵抗値とイオン交換膜を設置しない場合の該電極間の抵抗値の差抵抗値を膜抵抗値とした。なお、上記測定に使用する膜は、あらかじめ3mol/lの硫酸水溶液中で平衡にしたものを用いた。
三次元粗さ測定器(小坂研究所製TDF−3A型)を用いて、イオン交換膜表面の表面粗さを測定した。得られた粗さ曲線において、評価長さを11mmとして測定した十点平均粗さ(Rz)をもってイオン交換膜の表面粗さとした。
10質量%のポリビニルアルコール(日本合成製NH−20)の水溶液をろ紙(アドバンテック製化学分析用ろ紙5C)上に塗布した。塗布量は、溶媒除去後にポリビニルアルコールが2mg/cm2となるようにした。その後、室温で24時間以上放置して水を揮散させて仮想皮膚を得た。次いで、図2に示すように、該仮想皮膚20と測定対象とする被検膜(イオン交換膜等)21とを密着させてセルの中央に設置した。薬液室22に所定濃度の薬剤の水溶液を、仮想皮膚室23には0.9質量%の塩化ナトリウム水溶液を満たした。次いで、薬液室22内と仮想皮膚室23内とを攪拌しながら、25℃で所定時間透過試験を行った。試験終了後、直ちに仮想皮膚室23内の液を抜き取り、これを測定試料とした。測定試料中の薬剤量を高速液体クロマトグラフを用いて測定した。
仮想皮膚(ポリビニルアルコールを塗布したろ紙)の代わりに、生体皮膚としてミニブタ(Yucatane Micropig、5ヶ月齢、メス)の背部皮膚を用い、仮想皮膚系と同じ方法で薬剤透過量を測定した。
クロロメチルスチレン380g、ジビニルベンゼン20g、t−ブチルパーオキシエチルヘキサノエート20gからなる単量体組成物を調整し、この単量体組成物420gを500mlのガラス容器に入れた。この単量体組成物中に20cm×20cmの多孔質膜(質量平均分子量25万のポリエチレン製、膜厚25μm、平均孔径0.03μm、空隙率37%)を大気圧下、25℃で10分浸漬し、この多孔質膜に単量体組成物を含浸させた。続いて、上記多孔質膜を単量体組成物中から取り出し、厚さ100μmのポリエステルフィルムでこの多孔質膜の両側を被覆した後、平滑なステンレス板2枚の間に挟み込み、0.29MPa(3kg/cm2)の窒素加圧下、80℃で5時間加熱重合した。次いで、得られた膜状物をトリメチルアミン15質量%、水60質量%、アセトン25質量%よりなるアミノ化浴に浸漬し、室温で5時間反応せしめ4級アンモニウム型陰イオン交換膜を得た。
単量体組成物、及び多孔質膜を表1に示した組成に代えた以外は製造例1と同様にして陰イオン交換膜を製造した。得られた膜の物性を表1に示す。
製造例1と同様にして、表1に示す単量体組成物を多孔質膜に含浸させ、続いて、多孔質膜を単量体組成物中から取り出した。100μmのポリエステルフィルムで多孔質膜の両側を被覆した後、これをステンレス製の平板2枚の間に挟み込み、0.29MPa(3kg/cm2)の窒素加圧下、45℃で3時間、ついで75℃で5時間加熱重合した。次いで、得られた膜状物をヨウ化メチルとn−ヘキサンの1:3(質量比)の混合液中に30℃で24時間浸漬し、4級ピリジニウム型陰イオン交換膜を得た。
陰イオン性の薬剤であるアスコルビン酸リン酸エステルマグネシウム塩の10mmol/L溶液を用いて仮想皮膚系での薬剤透過量を測定した。用いたイオン交換膜と薬剤透過量とを表2に示す。
織布を基材とする陰イオン交換膜であるネオセプタAMX(トクヤマ製;膜物性は表1に記載)を用いた以外は、実施例1と同様にして薬剤透過量を測定した。結果を表2に示す。
測定対象イオン交換膜を使用せず、仮想皮膚のみを用いて実施例1と同様にして薬剤透過量を測定した。結果を表2に示す。
アスコルビン酸リン酸エステルマグネシウム塩の10mmol/L溶液に代えて、アスコルビン酸ナトリウム塩の10mmol/L溶液を用いて製造例1で得た膜の仮想皮膚系での薬剤透過量を測定した。結果を表3に示す。
織布を基材とするイオン交換膜として、陰イオン交換膜であるネオセプタAMX(トクヤマ製;膜物性は表1に記載)を用いた以外は、実施例7と同様にして薬剤透過量を測定した。結果を表3に示す。
測定対象イオン交換膜を使用せず、仮想皮膚のみを用いて実施例7と同様にして薬剤透過量を測定した。結果を表3に示す。
陽イオン性の薬剤である、ヒスタミン二塩酸塩の10mmol/L溶液を用いて仮想皮膚系での薬剤透過量を測定した。用いたイオン交換膜と薬剤透過量の結果を表4に示す。なお、実施例13で用いたNafion112(デュポン社製;膜物性は表1に記載)は非架橋の陽イオン交換膜である。
陰イオン性の薬剤であるアスコルビン酸ナトリウムの10mmol/L溶液を用いて生体皮膚系での薬剤透過量を測定した。用いたイオン交換膜と薬剤透過量の結果を表5に示す。
陰イオン性の薬剤であるアスコルビン酸りん酸エステルマグネシウム塩の10mmol/L溶液を用いて生体皮膚系での薬剤透過量を測定した。用いたイオン交換膜と薬剤透過量の結果を表6に示す。
2:生体との接触面の表面粗さ(Rz)が7μm以下のイオン交換膜
3:イオン性薬剤含有層
4:フィルム状外装材
5:貼付材周縁部の接合部
6:周縁部
20:仮想皮膚または生体皮膚
21:被検膜
22:薬液室
23:仮想皮膚室
100:貼付材
Claims (3)
- 電圧を印加することなく、生体表面から生体内にイオン性薬剤を浸透させることにより、生体にイオン性薬剤を投与するために用いる貼付材であって、該貼付材は、生体表面と接触させる部位の表面粗さ(Rz)が7μm以下のイオン交換膜と、該イオン交換膜内に含浸せしめられたイオン性薬剤とを有し、かつ該イオン交換膜が、熱可塑性樹脂からなる多孔質膜を基材とし、該基材内の空隙にイオン交換樹脂を含有してなるイオン交換膜であることを特徴とする、生体に対するイオン性薬剤投与用の貼付材。
- イオン交換樹脂が、架橋されたイオン交換樹脂である請求項1に記載の貼付剤。
- イオン交換膜の生体表面と接触する部位を有する側とは反対側に、イオン性薬剤含有層がさらに設けられてなる請求項1又は2に記載の貼付材。
Priority Applications (1)
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JP4731931B2 (ja) | 2005-02-03 | 2011-07-27 | Tti・エルビュー株式会社 | イオントフォレーシス装置 |
JP2006296511A (ja) * | 2005-04-15 | 2006-11-02 | Transcutaneous Technologies Inc | 外用剤、外用剤の塗布方法、イオントフォレーシス装置及び経皮パッチ |
US8295922B2 (en) | 2005-08-08 | 2012-10-23 | Tti Ellebeau, Inc. | Iontophoresis device |
US8386030B2 (en) | 2005-08-08 | 2013-02-26 | Tti Ellebeau, Inc. | Iontophoresis device |
JP2007050136A (ja) * | 2005-08-18 | 2007-03-01 | Transcutaneous Technologies Inc | イオントフォレーシス装置 |
EP1965856A2 (en) | 2005-12-30 | 2008-09-10 | Tti Ellebeau, Inc. | Iontophoretic systems, devices, and methods of delivery of active agents to biological interface |
JP2013075855A (ja) * | 2011-09-30 | 2013-04-25 | Tokuyama Corp | イオン交換樹脂の製造方法 |
GB2568498A (en) * | 2017-11-17 | 2019-05-22 | Sumitomo Chemical Co | Materials reducing formation of hypochlorite |
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