JPH0643298B2 - 医療用材料 - Google Patents

医療用材料

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Publication number
JPH0643298B2
JPH0643298B2 JP1114896A JP11489689A JPH0643298B2 JP H0643298 B2 JPH0643298 B2 JP H0643298B2 JP 1114896 A JP1114896 A JP 1114896A JP 11489689 A JP11489689 A JP 11489689A JP H0643298 B2 JPH0643298 B2 JP H0643298B2
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JP
Japan
Prior art keywords
iodine
sensitive adhesive
pressure
medical material
solution
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 - Lifetime
Application number
JP1114896A
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English (en)
Other versions
JPH0257262A (ja
Inventor
デビッド ロツソ ポール
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3M Co
Original Assignee
Minnesota Mining and Manufacturing Co
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Application filed by Minnesota Mining and Manufacturing Co filed Critical Minnesota Mining and Manufacturing Co
Publication of JPH0257262A publication Critical patent/JPH0257262A/ja
Publication of JPH0643298B2 publication Critical patent/JPH0643298B2/ja
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
    • A01N59/12—Iodine, e.g. iodophors; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/58—Adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00655—Plasters adhesive
    • A61F2013/0071—Plasters adhesive containing active agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/106—Halogens or compounds thereof, e.g. iodine, chlorite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Plant Pathology (AREA)
  • Inorganic Chemistry (AREA)
  • Pest Control & Pesticides (AREA)
  • Agronomy & Crop Science (AREA)
  • Dentistry (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Environmental Sciences (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Materials For Medical Uses (AREA)

Description

【発明の詳細な説明】 本発明は抗菌性でかつ皮膚医学的に許容しうる感圧性粘
着物を利用した医療用材料に関する。
多くの病原微生物が人の皮膚に存在する。病院環境では
病原微生物の生育は阻止されることおよび好ましくはこ
れらの微生物は患者の感染を抑制し傷の回復を増進する
ように殺滅されることが一般に望ましい。その結果局所
的殺菌活性剤の皮膚表面への適用は病院の防腐技術の標
準的要素となつた。
しばしば使用される抗菌剤は沃素であるが、その固有の
化学的および物理的制約のために、防腐性広スペクトル
抗菌剤としてその使用は限定されている。沃素元素は高
蒸気圧を有し、それは抗菌剤として沃素を含む抗菌製剤
から沃素含量が揮発するので殺菌効力に大きなロスを生
じる。更に沃素は皮膚の腐食破壊性の可能性のあるため
に一般に包帯に含ませることはない。
沃素の抗菌活性を保有させ、同時に腐食性および蒸気圧
を減少させるためにポリビニルピロリドンと沃素の複合
物が形成された。このようなポリビニルピロリドン−沃
素複合物（ＰＶＰ−Ｉ）の１つの合成例が米国特許第4,
128,633号明細書に開示される。
広スペクトル抗菌剤の局所適用は手術前皮膚適用物、外
科用清浄テイツシユペーパー例えば米国特許第4,054,36
4号明細書、洗滌剤、傷清浄剤、ローシヨンおよび軟膏
の形であつた。ある場合にはこのような使用法は一定時
間内での特別目的に対しては有効である。抗菌剤の初め
の適用で生き残ることができる微生物は種として作用し
てある場合には病原菌数を初めのレベルまで上昇させ
る。局所への抗菌剤の連続的適用は固体群の増加を阻止
する方法である。
多数の他の生物学的活性剤は基質上の粘着層に添加さ
れ、その剤を身体に連続的に適用されたが、広スペクト
ル抗菌剤の安定性および不変の活性を特徴とした広スペ
クトル抗菌剤の粘着層への添加は全く成功しなかつた。
粘着物に添加した各種の他の剤の例はフエノール、チモ
ール、メントールなどを澱粉粘着物に添加する米国特許
第2,137,169号明細書、ベンゾカインを粘着性ゼラチン
に添加する米国特許第3,249,109号明細書、カルチコス
テロイドを粘着物に添加する米国特許第3,632,740号明
細書、マイクロカプセル化抗腫瘍剤を粘着物に添加する
米国特許第3,734,097号明細書、トレチノイン(Tretinoi
n)を粘着物に添加する米国特許第4,073,291号明細書、
５−フルオロウラシルを粘着物に添加する米国特許第3,
769,071号明細書、レチノン酸を感圧性テープに添加す
る米国特許第3,896,789号明細書である。粘着物に広ス
ペクトル抗菌剤を添加することの従来の試みは生物学的
活性の減少およびある患者の場合皮膚刺激を生ずる制御
できない遊離により挫折した。
広スペクトルなる用語は抗菌剤が１タイプ以上の微生
物、すなわちグラム陽性菌およびグラム陰性菌の両者に
対し活性を示し、かびおよびウイルスに対しても活性を
恐らく有するであろうことを意味するために本明細書で
使用される（参照：Tederal Register,39巻、179号）。
本発明は皮膚と接触させた時に、均一且制御された形で
広スペクトル抗菌剤沃素を放出する安定性が高く持続効
果を有する医療用材料を提供するものである。この放出
は照射殺菌にかけた後でさえ実質的に不変の広スペクト
ル抗菌活性を有したまま起こる。この防腐抗菌活性は実
質的に皮膚刺激なしに本発明により達成される。
本発明に係る医療用材料は沃素、沃化物イオンおよび皮
膚医学的に許容しうる通常室温で粘着性感圧性粘着物
（ＰＳＡ）の安定な化学複合物を使用するものである。
「安定」とはポリエチレンシートに付着する24平方イン
チにつき11グレンの組成物被覆は、120゜Fの温度および
９％の相対湿度に２週間もしくは澱粉テストで試験する
時に物理的外観もしくは化学的活性の実質的変化なしに
およびゾーンインヒビシヨン アセイ(Zone Inhibition
Assay)で試験する時に微生物活性の実質的変化なしに
2.5メガラドのガンマー照射の照射量に曝露することが
できることを意味する。
ゾーン インヒビシヨン アセイ テストは次のように
行なわれる：アセイ細菌バチルス サブチリス(Bacillu
s subtilis)は約６時間37℃で回転振盪培地(200rpm)で
生育させる。生育培地Ｌ−ブロスは１の蒸留水に溶解
し、pH7.0に調整した次の成分より成る：トリプトン10
ｇ、酵母エキス５ｇ、食塩10ｇ、グルコース１ｇ。この
カルチヤーは滅菌Ｌ−ブロスに660mmで50％Ｔまで稀釈
され、更に１：10に稀釈され、45〜50℃に維持された融
解大豆−カゼイン消化寒天培地(Inolex)に１：100の割
合で接種される。アセイプレートは大豆−カゼイン消化
寒天培地（ＴＳＡ）の５ml基底層を最初にピペツトでと
り、これを室温で任意に使用できるペトリ皿中で硬化さ
せ、次に５mlの接種ＴＳＡで覆うことにより製造され
る。これらの調製物はその日に使用される。
被覆ポリエチレンフイルム（以下の例で教示する方法で
製造）は粘着層に添加する抗菌剤と無関係に同じ方法で
試験される10個の６mmデイスクは丈夫な紙穴あけ器(Mas
ter Products,Series25)により均一被覆された区域（す
なわち目に見える傷の全くない）から切り取られる。紙
支持体は鉗子および小へらにより被覆デイスクから除去
される。次に被覆デイスクは１プレートにつき４個が接
種寒天表面に粘着物側面を下にして入れる。
次に沃素参考デイスクが製造される。10％沃素を含む溶
液は１ｇの沃素および１ｇの沃化ソーダを10ml容量フラ
スコを使用し10％水性アセトンに溶解して製造される。
新しく製造され且同じ溶媒のこの貯蔵溶液は0.25、0.5、
0.75および1.0％沃素溶液を製造するために使用され
る。これらの稀釈液から、10μ試料は接種寒天表面上
においた６mmポリエステル地デイスクに適用され、25、5
0、75および100μｇ沃素をそれぞれ含むデイスクが供さ
れる。（ポリエステル地は一夜溶媒中にさらし、穴あけ
前に固有の抗菌活性を除去すべきである。）各参考デイ
スクは２−mlポリエチレンの１インチ平方により被覆
し、下層寒天中に拡散する前の蒸散を阻止する。
被覆デイスクおよび参考デイスク アセイ プレートは
一夜室温でインキユベートされる。デイスクの回りの阻
止ゾーンは双眼実体顕微鏡によりほぼ0.5mmまでのもの
まで測定された。沃素抗菌剤の場合には、被覆デイスク
も除去されデイスク下の生育阻止面積に対しプレートが
調査される。
上記方法を使用する参考抗菌剤に対するアセイ結果は、
mmで測定した阻止ゾーンの直径は試験範囲では各剤に対
しLog10濃度に直線的に比例することを照明する。本発
明に係る医療用材料からの抗菌剤の放出は阻止値のグラ
フから内挿法により推定することができる。
でん粉テストは次のように行なわれる：指示薬溶液はパ
ラゴン アイオデイン タイトレーシヨン インデイケ
ーター(paragon Iodine Titration Indicator)(Eastern
Chemical,Division of Guardian Chemical Corp.,Hanp
pauge,NY)62.5ｇを250mlの蒸留水に攪拌しながら溶解し
て製造する。それからのパラゴン インデイケーター溶
液の１滴は粘着物表面におかれる。その小滴中の青色形
成は沃素の有効性を示す。
本発明の医療用材料に使用される感圧性粘着物組成物は
感圧性粘着物を形成し、それに沃素、沃化物および溶媒
より成る抗菌剤処理溶液と混合することにより調製され
る。かくして得られた組成物は好ましくは感圧性粘着物
の本体に沃素の複合化に供するＮ−ビニルピロリドン
（ＮＶＰ）を含む。複合化は安定化を供し、一方適当な
平衡を維持して沃素の持続性遊離を供すると信じられ
る。
上記方法の生成化学複合物である組成物は安定で、刺激
性がなく、感作性がなく、無毒で且皮膚もしくは他の組
織に対し全く損傷性がない。酸性媒体は多くの広−スペ
クトル抗菌剤、すなわちＰＶＰ−Ｉを一層安定化するこ
とが一般に認められるが、かなりの酸含量を有する感圧
性粘着物は本システムでは沃素の安定性に負の変化を生
ずる。従つて本医療用材料のベースとして作用する通常
室温で粘着性感圧性粘着物モノマーは実質的に酸成分を
含まないことが望ましい。「実用的に酸成分を含まな
い」とは感圧性粘着物モノマーは機能的に酸性を示す例
えばアクリル酸などの置換基を実質的に含まないことを
意味する。本医療用材料に使用される抗菌組成物ＰＳＡ
を含む調製物に使用することができる粘着物モノマーの
例はアクリル樹脂およびビニル／アクリル樹脂を含む。
これら粘着物の処方は当業者には周知で例えば米国特許
ＲＥ24906、米国特許第2,973,286号、同第3,307,544
号、同第3,728,148号各明細書などである。上記粘着物
タイプは状況により指令された効用を有することができ
るように各種の化学加工剤例えば粘着剤、架橋剤、安定
剤、開始剤などを含むことができることは当業者には認
められるであろう。本発明に使用する好ましい感圧性粘
着物はＮ−ビニルピロリドン（ＮＶＰ）およびイソオク
チルアクリレート（ＩＯＡ）より成るコポリマーであ
る。
沃素の放出は粘着物本体に低レベルのＮＶＰをコポリマ
ー化することにより制御されることが信じられる。粘着
物マトリツクスから沃素の遊離は粘着物本体にコポリマ
ー化されたＮＶＰレベルの函数である。一定沃素含量に
対してはＮＶＰレベルの高い程抗菌活性は低下する。本
発明に対し有用なＮＶＰコモノマーレベルは全粘着物固
形の30％（選択的には５〜10％）より少ない。より高い
ＮＶＰレベルでは皮膚粘着および抗菌活性が減少する。
抗菌剤溶液は、感圧性粘着物に沃素を添加するために使
用される。この溶液は沃素、無機沃化物（例えば沃化カ
リ）および粘着物と相容性の適当な溶媒を含む。上記５
〜10％ＮＶＰコポリマー粘着物と共に使用する推奨溶液
は変性エタノールに溶解した0.5：１〜４：１モル比の
沃化物：沃素（好ましい溶液２：１モル比の沃化物：沃
素）を有するであろう。たとえば、沃化ソーダを使用す
る溶液は１〜20重量％沃素、1.2〜24重量％沃化ソーダ
および97.8〜56重量％エタノールを有するであろう。
本発明の粘着物マトリツクスへの沃素の複合化機作は完
全に理解されないが、沃素とポリビニルピロリドンの複
合化にはいくつかの相似性を有することが信じられる。
次は本発明の複合物の１つの可能な表現である： 式中、ｍ，ｎ，ｏおよびｐは整数である。
本発明に係る医療用材料に使用する組成物は屈撓性支持
体基質上に直接付着するか、又は先ず最初に遊離ライナ
ー上に形成させ利用することができる。支持体は医療用
に使用する既知の任意の材料を使用することができる
が、好ましい材料はポリエチレンフイルムである。次に
溶媒は当業者に既知の方法により蒸発させ、粘着フイル
ムを形成させてテープ、滅菌布(drape)などの本発明に
係る医療用材料を得ることができる。
本発明は更に次の非限定例により例示される。
イソオクチルアクリレート／Ｎ−ビニルピロリドン／−
メタクリルオキシプロピルトリメトキシシラン（94.95
／５／0.05）組成の溶液ポリマー粘着物をエチルアセテ
ート／ヘプタン／エタノール（48/47／５）中で重合さ
せて製造する（条件：窒素雰囲気、アゾビスイソブチロ
ニトリル開始剤、53℃６時間；性質：全固形45％、固有
粘度0.8）。
次の処方物を製造する： 上記粘着物 500ｇ 20重量％％沃素を含む溶液／変性エタ ノール中の24重量％の沃化ソーダ 11ｇ 付加変性エタノール 78ｇ 10重量％ｐ−トルエンスルホン酸 （ｐ−ＴＳＡ）変性エタノール溶液 （粘着物固形について0.1重量％ ｐ−ＴＳＡ） 2.3ｇ 処方物は室温でへらにより攪拌し、粘着物固形について
１重量％沃素／1.2重量％沃化ソーダの均一溶液を得
る。この溶液はシリコン遊離ライナー上に被覆し、乾燥
（10分、175゜F）して、11グレン／24平方インチに等し
い被覆重量の均質沃度色粘着物フイルムを形成させる。
粘着物フイルムはコロナ(corona)および４級アミン帯電
防止剤処理ポリエチレンの支持体にラミネートし、抗菌
剤沃素を含む構造物を形成させる。この構造物は接種し
た人の皮膚で生体に適用した時に、１時間後に、スタフ
イロコツカス アウレウス(Staphylococcus aureus)お
よびシユードモナス エアルギノサ(Pseudomonas aerug
inosa)を４log減少させる活性を示した。構造物は照射
滅菌後満足すべき粘着および安定性を示した。
───────────────────────────────────────────────────── フロントページの続き (56)参考文献 特開 昭56−22728（ＪＰ，Ａ) 特開 昭56−22727（ＪＰ，Ａ) 特開 昭51−142094（ＪＰ，Ａ) 特開 昭47−42842（ＪＰ，Ａ)

Claims (3)

    【特許請求の範囲】
  1. 【請求項１】沃化物、沃素および皮膚医学的に許容しう
    る30重量％以下のＮ−ビニルピロリドンを含む感圧性粘
    着共重合体の安定な化学複合物を含む粘着性層と屈撓性
    シート材料よりなる感圧性粘着医療用材料。
  2. 【請求項２】前記屈撓性シート材料がポリエチレンフイ
    ルムである特許請求の範囲第１項記載の感圧性粘着医療
    用材料。
  3. 【請求項３】医療用材料がテープの形で供されたもので
    ある特許請求の範囲第１項記載の感圧性粘着医療用材
    料。
JP1114896A 1979-07-31 1989-05-08 医療用材料 Expired - Lifetime JPH0643298B2 (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/062,362 US4323557A (en) 1979-07-31 1979-07-31 Pressure-sensitive adhesive containing iodine
US62362 1979-07-31

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
JP10494780A Division JPS5622727A (en) 1979-07-31 1980-07-30 Pressure sensitive adhesive containing iodine

Publications (2)

Publication Number Publication Date
JPH0257262A JPH0257262A (ja) 1990-02-27
JPH0643298B2 true JPH0643298B2 (ja) 1994-06-08

Family

ID=22041975

Family Applications (2)

Application Number Title Priority Date Filing Date
JP10494780A Granted JPS5622727A (en) 1979-07-31 1980-07-30 Pressure sensitive adhesive containing iodine
JP1114896A Expired - Lifetime JPH0643298B2 (ja) 1979-07-31 1989-05-08 医療用材料

Family Applications Before (1)

Application Number Title Priority Date Filing Date
JP10494780A Granted JPS5622727A (en) 1979-07-31 1980-07-30 Pressure sensitive adhesive containing iodine

Country Status (8)

Country Link
US (1) US4323557A (ja)
EP (1) EP0024107B2 (ja)
JP (2) JPS5622727A (ja)
AU (1) AU537351B2 (ja)
CA (1) CA1151548A (ja)
DE (1) DE3065603D1 (ja)
ES (1) ES493775A0 (ja)
ZA (1) ZA804631B (ja)

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JPH0257262A (ja) 1990-02-27
JPH0149499B2 (ja) 1989-10-25
ES8106655A1 (es) 1981-09-01
EP0024107B2 (en) 1991-01-16
AU6087180A (en) 1981-02-05
US4323557A (en) 1982-04-06
JPS5622727A (en) 1981-03-03
ES493775A0 (es) 1981-09-01
DE3065603D1 (en) 1983-12-22
EP0024107B1 (en) 1983-11-16
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ZA804631B (en) 1981-07-29
EP0024107A1 (en) 1981-02-25

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