JPWO2006112443A1 - トリアセチンの新規な利用方法及び超音波診断の検査補助剤 - Google Patents
トリアセチンの新規な利用方法及び超音波診断の検査補助剤 Download PDFInfo
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- JPWO2006112443A1 JPWO2006112443A1 JP2007528144A JP2007528144A JPWO2006112443A1 JP WO2006112443 A1 JPWO2006112443 A1 JP WO2006112443A1 JP 2007528144 A JP2007528144 A JP 2007528144A JP 2007528144 A JP2007528144 A JP 2007528144A JP WO2006112443 A1 JPWO2006112443 A1 JP WO2006112443A1
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- triacetin
- gastric motility
- solution
- stomach
- ultrasonic
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- CCXAYLQLOLXXKE-DWJAGBRCSA-K trisodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4s,5s,6s)-2-[[(3s,4ar,6ar,6bs,8as,11s,12ar,14ar,14bs)-11-carboxylato-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1h-picen-3-yl]oxy]-6-carboxylato-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-t Chemical group [Na+].[Na+].[Na+].O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C([O-])=O)C([O-])=O)[C@@H]1O[C@H](C([O-])=O)[C@@H](O)[C@H](O)[C@H]1O CCXAYLQLOLXXKE-DWJAGBRCSA-K 0.000 description 1
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/22—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations
- A61K49/221—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations characterised by the targeting agent or modifying agent linked to the acoustically-active agent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Emergency Medicine (AREA)
- Physics & Mathematics (AREA)
- Acoustics & Sound (AREA)
- Radiology & Medical Imaging (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
(1)粘性が高くないこと(理由は飲用性が悪く超音波検査の簡便性を損なうこと及び粘性の高い液体ほど気泡が消えないため)
(2)水中油型エマルジョンや油滴の分散は避けること(理由は超音波を反射もしくは屈折させるため)
(3)不溶性粒子やゲル様粒子は避けること(理由は超音波を反射もしくは屈折させるため)
(4)難消化性の水溶性重合体は避けること(理由は膠質浸透圧を発生させ、下痢を誘発させるため)
したがって、粘性や非消化性の水溶性重合体に依らない胃部滞留性の超音波検査用等の薬剤が強く望まれ、これら全ての条件を満たすものとしてトリアセチン製剤の開発を実施した。
(弊所注:貴社が「トリアセチンを添加する医薬品以外の商品の出現を抑止効果」をご希望であることを考慮し、上記記載を追加しました。これにより、他社が医薬品以外で権利をとることについてある程度の抑止効果を期待出来るものと思料致します。但し、これによって(あるいは、当初の請求項1によって)、トリアセチンを添加する医薬品以外の商品が公知であるとまでは言えないにしても、容易に想到し得る(進歩性の否定)とは言えるものと考えます。)
以下、本発明を実施例によりさらに詳細に説明するが、本発明の範囲は実施例により何ら制限されない。
実施例1(トリアセチン(0.5%))
水200mLをマグネチックスターラーで撹拌しながらにトリアセチン1.5g、pH調整剤としてクエン酸0.24g及びクエン酸三ナトリウム1.74g、甘味剤としてグリセリン3gを添加後80℃に加熱した。
(A)トリアセチン:1.5g
(B)緩衝剤:クエン酸:0.24g
(C)緩衝剤:クエン酸三ナトリウム:1.74g
(D)甘味剤:グリセリン:3g
(E)溶解補助剤:プロピレングリコール:0.45g
(F)防腐剤:パラオキシ安息香酸エチル:0.012g
(G)防腐剤:パラオキシ安息香酸ブチル:0.027g
(H)矯味剤:l−メントール:0.006g
(I)溶解補助剤:エタノール:適量
実施例2(トリアセチン(0.5%))
水200mLをマグネチックスターラーで撹拌しながらにトリアセチン1.5g、pH調整剤としてクエン酸0.24g及びクエン酸三ナトリウム1.74g、甘味剤としてサッカリンナトリウム0.03gを添加後80℃に加熱した。
(A)トリアセチン:1.5g
(B)緩衝剤:クエン酸:0.24g
(C)緩衝剤:クエン酸三ナトリウム:1.74g
(D)甘味剤:サッカリンナトリウム:0.03g
(E)溶解補助剤:プロピレングリコール:0.45g
(F)防腐剤:パラオキシ安息香酸エチル:0.012g
(G)防腐剤:パラオキシ安息香酸ブチル:0.027g
(H)苦み抑制剤:グリシン:3g
(I)矯味剤:l−メントール:0.006g
(J)溶解補助剤:エタノール:適量
実施例3(トリアセチン(10%))
トリアセチン30gとポリオキシエチレン(30)硬化ヒマシ油〔日光ケミカルズ株式会社:NIKKOL HCO−30〕4.5gをこの割合になるように混合し、高性能撹拌分散器ウルトラ−タラックス(IKA JAPAN CO.,LTD.製)で撹拌し混合液を得た。
(A)トリアセチン:30g
(B)ポリオキシエチレン(30)硬化ヒマシ油:4.5g
(C)カルメロースナトリウム:0.6g
(D)クエン酸:0.24g
(E)クエン酸三ナトリウム:1.74g
(F)サッカリンナトリウム:0.03g
(G)プロピレングリコール:0.45g
(H)パラオキシ安息香酸エチル:0.012g
(I)パラオキシ安息香酸ブチル:0.027g
実施例4(トリアセチン(顆粒剤))
シリコーン樹脂0.83g、モノオレイン酸ポリオキシエチレンソルビタン(NIKKOL:TO−10M)0.216g、セスキオレイン酸ソルビタン(NIKKOL:SO−15R)0.089gをIPA100gに懸濁させ、PVPを1g添加し、PVPを完全に溶解させた(シリコーン溶液)。
試験例1:トリアセチンと水及び増粘性多糖類との粘度比較
水(イオン交換水)、トリアセチン水溶液および代表的な増粘性多糖であるアルギン酸ナトリウム〔(株)キミカ、グレード:IL−2〕水溶液を用いて粘度の比較を行った。また粘度は室温(22℃)でB型粘度計〔(株)東京計器製、形式BM〕を用いて測定した。
a)試験液について
試料液A
トリアセチン(和光純薬工業(株))10mLに水40mLを加えて、全量50mLとし、試料液Aとする。
試料液B
オリーブ油(和光純薬工業(株))10mL、プロピレングリコール10mLを混和し、水を加えて全量50mLとし、試料液Bとする。
試料液C
ステアリン酸(和光純薬工業(株))0.5g、プロピレングリコール20mLを混和し、水を加えて全量50mLとし、試料液Cとする。
b)モデルの説明
体重約10kgのビーグル犬をネンブタール注射液(大日本製薬(株))で全身麻酔をして、正中切開ののち図8のように胃体部、十二指腸にチューブを挿入し、側腹部から背部の皮下にそれぞれチューブを通して無麻酔での実験のためにあらかじめ観血的手術を施行した。
c)試験方法
試料液に5mgのエバンスブルー(和光純薬工業(株))を加え、50mLをビーグル犬胃内に図8の1のチューブから注入する。また、十二指腸内にもチューブを敷設しておき、胃からの排出された試験液を図8の2のチューブから回収する。一定時間毎に十二指腸に留置したチューブから吸引回収(1分間)し、その中に含有されるエバンスブルーを波長605nmで吸光度測定(DU R640 SPECTRO PHOTOMETER,Beckman社製)することにより吸引液内のエバンスブルーの濃度を測定し、その回収量から胃排出速度を求めた。
d)結果
生理食塩液を比較対象とした結果、これらの実験例は明らかに幽門閉塞性を有するものであり、また中でもトリアセチンは幽門閉塞性の効果が顕著にみられた。
1)トリアセチン
本目的で重要な意味を持つ投与初期段階の比較では、図10のごとく生理食塩液に比し明らかに抑制が認められる。その結果、図9のごとく、排出量は、生理食塩液では5分程度でピークになるが、トリアセチンではそれより遅い10〜20分程度でピークとなっており、本目的に適う結果である。また生理食塩液は投与後、30分程度でほとんど全て排出されているが、トリアセチンは50分後でも残留し、5%程度の排出が観察され、この時点を比較表示すると図11のごとくトリアセチンの排出が生理食塩液に比し、明らかに遅滞している。このことから生理食塩液に比し、あきらかに通過量は抑制されている。
2)オリーブ油
図12のごとく、排出量は、生理食塩液では投与後30分までにほとんど全て排出されているが、オリーブ油は40分後でも15%程度排出されており、生理食塩液に比し、あきらかに胃排出量は抑制されている。
3)ステアリン酸
図13のごとく、排出量は、生理食塩液では投与後30分までにほとんど全て排出されているが、ステアリン酸は50分後でも10%程度排出されており、生理食塩液に比し、あきらかに胃排出量は抑制されている。
試験例3:胃収縮運動測定
a)試験液について
試料液D
トリアセチン(和光純薬(株))200μLを蒸留水で20mLに調製し、試料液Dとする。
試料液E
オリーブ油(和光純薬(株))4mLを蒸留水で20mLに調製し、試料液Eとする。
対照液F
蒸留水20mLを対照液Fとする。
b)モデルの説明
体重約10kgのビーグル犬をネンブタール注射液(大日本製薬(株))で全身麻酔をして、正中切開ののち、図14のように胃体部に試験液を注入するためのチューブおよび幽門輪より2cm口側の前庭部にストレンゲージ(N11−FA−1−120−11−P4−W,NEC Sanei−Instruments,Ltd)を縫着した。ストレンゲージは、筋肉の収縮を測定するため、粘膜面を切開しないように粘膜下組織を広げて粘膜下組織内に埋没縫着し、切開創は縫合閉鎖した。
チューブおよびストレンゲージは、側腹部から背部の皮下を介して体外に誘導し、無麻酔での実験のためにあらかじめ観血的手術を施行した。
麻酔の影響や手術侵襲の影響がなくなり一般状態も回復した術後6日後より、目的とする各試料液の検討を開始した。すなわち、本実施例では麻酔状態では、胃収縮運動が抑制されることは周知のことであり、その影響をなくすため、さらに、より正常な状態での成績を求めるために慢性無麻酔での実験を行った。
なお、ストレンゲージの信号は、増幅(VC−11,NIHON KOHDEN)させた後、AD変換し、デジタル化されたデータをOrigin Version6.5(OriginLab corporation)により解析した。
c)試験方法
トリアセチンの胃収縮運動に対する影響を検討するために、ビーグル犬をサドル型保持器に乗せ、十分に慣れさせた。その後に、筋組織に装着したストレンゲージからビーグル犬が空腹期胃運動の状態にあることを確かめた(図15)。静止期に相当するphaseIが図15中央に、不規則な収縮波に相当するphaseIIが図15右側に、規則正しい強収縮波に相当するphaseIIIが図左側に観察された。試験液の添加は、phaseIIIの収縮期の間に、試験液を胃管よりゆっくりと約1分かけて胃内へ注入し、収縮反応を観察した。なお、実験に用いたビーグル犬は、実験開始の15時間以上前から水以外を絶食とした。
d)試験結果
試料液Eや対照液Fと比較した結果、これらの実施例からは、明らかにトリアセチンが胃収縮運動を抑制するものであった。
1)トリアセチン
トリアセチン(20μL/kg)の注入は、注入前には観察されていた収縮の振幅および頻度をともに減少させ,収縮運動を抑制した(図16)。この変化は注入直後から観察され、約3分間続いた。
2)オリーブ油
オリーブ油(0.4mL/kg)の注入は、注入前には観察されていた収縮の振幅および頻度に変化を与えなかった(図16)
3)蒸留水
蒸留水(2g/kg)の注入は,注入前には観察されていた収縮の振幅および頻度に変化を与えなかった(図16)
Claims (8)
- 少なくとも一種の生体適合性を持った胃運動抑制性の成分を含有することを特徴とする、臓器に超音波を伝播しうる超音波診断用検査補助剤。
- トリアセチンを胃運動抑制性の成分として含有することを特徴とする請求項1記載の検査補助剤。
- 少なくとも一種の生体適合性を持った胃運動抑制性の成分を含有することを特徴とする、臓器に超音波を伝播しうる検査補助剤、当該検査補助剤を投与するための指示書、及びパッケージ用品を含むキット。
- トリアセチンを胃運動抑制性の成分として含有することを特徴とする請求項3記載のキット。
- トリアセチンを有効成分として含む胃運動抑制剤。
- 胃運動を抑制する医薬品製造におけるトリアセチンの使用。
- 有効量のトリアセチンを投与することを含む胃運動の抑制方法。
- トリアセチンを含む医薬品組成物、当該医薬品組成物の使用法が記載された使用説明書、及びパッケージ用品を含むキット。
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EP (1) | EP1875928A4 (ja) |
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US5160743A (en) * | 1988-04-28 | 1992-11-03 | Alza Corporation | Annealed composition for pharmaceutically acceptable drug |
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US5385147A (en) * | 1993-09-22 | 1995-01-31 | Molecular Biosystems, Inc. | Method of ultrasonic imaging of the gastrointestinal tract and upper abdominal organs using an orally administered negative contrast medium |
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US5939080A (en) * | 1997-01-10 | 1999-08-17 | The Procter & Gamble Company | Hydrophobic agents and non-polymeric surfactants use in oral care products |
US6416740B1 (en) * | 1997-05-13 | 2002-07-09 | Bristol-Myers Squibb Medical Imaging, Inc. | Acoustically active drug delivery systems |
KR20050012224A (ko) * | 2002-05-21 | 2005-01-31 | 다이이찌 산토리 파마 가부시키가이샤 | 그렐린 함유 의약 조성물 |
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