JP7138702B2 - カテーテルロック溶液としての使用のための4%クエン酸三ナトリウム溶液 - Google Patents
カテーテルロック溶液としての使用のための4%クエン酸三ナトリウム溶液 Download PDFInfo
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- JP7138702B2 JP7138702B2 JP2020516822A JP2020516822A JP7138702B2 JP 7138702 B2 JP7138702 B2 JP 7138702B2 JP 2020516822 A JP2020516822 A JP 2020516822A JP 2020516822 A JP2020516822 A JP 2020516822A JP 7138702 B2 JP7138702 B2 JP 7138702B2
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- lock solution
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- 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
- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
- A61L33/0005—Use of materials characterised by their function or physical properties
- A61L33/0011—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
-
- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
-
- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/21—Acids
-
- 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
-
- 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
- A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
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- Molecular Biology (AREA)
- Medicinal Chemistry (AREA)
- Hematology (AREA)
- Surgery (AREA)
- Materials Engineering (AREA)
- Materials For Medical Uses (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
本明細書に記載されるロック溶液の試料について、生体外試験を行った。簡潔には、6.9のpHで調合された滅菌4%クエン酸ナトリウムを予め充填した5mLのシリンジを調製した。4FR単一管腔カテーテル(Bard, Covington GA)を用いて、635個の試料を逆流に関して試験し、結果を図2に示した。理解できるように、平均逆流は、0.0±1.4446cmであった。
それぞれ6.9のpHを有する、クエン酸三ナトリウムの3つの異なるロットを用いて実験試料を調合した。これらの試料を、40±2℃/75±5%RHにおける促進エージング、および25±2℃/60±5%RHにおける実時間エージングにかけた。止血中の血液試料中に発生する機械的変化を監視することにより凝血塊形成の開始を計算することができるSonoclot(登録商標) Coagulation & Platelet Function Analyzer (Sienco Inc., Boulder Co)を用いて、全血に対する4%クエン酸ナトリウムロック溶液の抗凝固有効性を決定した。機構は、血液試料中の上下に移動する管状プローブである。試料が凝血の種々の段階を進行する際に、電子回路(トランスデューサ)が抵抗の増大を検出する。これは、マイクロコンピュータにより処理される一連の電子信号を発生させる。出力は、血液が初期に導入された際よりもより粘稠である、凝血塊形成の合計時間である。
本明細書に記載されるようなクエン酸ナトリウムロック溶液は例外的な安定性を例証し、製造日から2年間の保証貯蔵寿命を有すると信じられる。これを試験するために、3つの異なる塩のロットを用い、6.8から7.0までの範囲で変動するpHにおいて、5バッチの3mLおよび5mLの試験試料を調合し、4%クエン酸ナトリウムロック溶液の濃度およびpHを評価した。前述のように、これら試料を40±2℃/75±5%RHにおける促進エージング、および25±2℃/60±5%RHにおける実時間エージングにかけた。促進エージングの結果を0ヶ月、2ヶ月、3ヶ月、4ヶ月、6ヶ月、および6.5ヶ月において収集および分析し、一方、実時間エージングの結果を3ヶ月および6ヶ月において収集および分析した。第6表および第7表(下記)は、クエン酸ナトリウムの濃度に関する結果を与え、第8表および第9表(同様に下記)は、pHに関する結果を与える。
Claims (17)
- 3.8%(w/v)から4.2%(w/v)のクエン酸塩と、
注射用水と、
任意選択的に酸と
を含む、静脈カテーテル用のカテーテルロック溶液であって、
前記カテーテルロック溶液のpHは6.4と7.5との間であり、
前記カテーテルロック溶液は、抗凝固活性または抗菌活性を有する追加の成分を含まない
ことを特徴とするカテーテルロック溶液。 - 前記クエン酸塩は、クエン酸ナトリウム塩であることを特徴とする請求項1に記載のカテーテルロック溶液。
- 前記クエン酸塩は、クエン酸三ナトリウムであることを特徴とする請求項1に記載のカテーテルロック溶液。
- 前記カテーテルロック溶液は、酸をさらに含むことを特徴とする請求項1に記載のカテーテルロック溶液。
- 前記酸は、希釈された酸であることを特徴とする請求項4に記載のカテーテルロック溶液。
- 前記希釈された酸は、希塩酸(HCl)であることを特徴とする請求項5に記載のカテーテルロック溶液。
- 前記カテーテルロック溶液は、0.1%(v/v)と0.7%(v/v)の間の量で酸を含むことを特徴とする請求項1に記載のカテーテルロック溶液。
- 前記クエン酸塩は、クエン酸三ナトリウム二水和物を含むことを特徴とする請求項1に記載のカテーテルロック溶液。
- 前記カテーテルロック溶液は、4%(w/v)のクエン酸三ナトリウムと、注射用水(WFI)と、0.7%(v/v)の10%HClを含むことを特徴とする請求項1に記載のカテーテルロック溶液。
- 前記カテーテルロック溶液は、賦形剤を含まないことを特徴とする請求項1に記載のカテーテルロック溶液。
- 前記カテーテルロック溶液は、パラベン、アルコール、グリセロール、ポリエチレングリコール、クエン酸、および/またはポリソルベートを含まないことを特徴とする請求項1に記載のカテーテルロック溶液。
- 請求項1に記載のカテーテルロック溶液を作製する方法であって、前記方法は、注射用水中にクエン酸塩を溶解させる工程と、任意選択的にカテーテルロック溶液のpHが6.4と7.5との間になるまで酸を添加する工程とからなることを特徴とする方法。
- 3.8%(w/v)から4.2%(w/v)のクエン酸三ナトリウムと、
注射用水(WFI)と、
0.0%(v/v)から0.7%(v/v)の10%HClと
からなる、静脈カテーテル用のカテーテルロック溶液であって、
前記カテーテルロック溶液のpHは6.4と7.5との間である
ことを特徴とする、カテーテルロック溶液。 - 4%(w/v)のクエン酸三ナトリウムと、
注射用水(WFI)と、
0.7%(v/v)の10%HClと
からなる、静脈カテーテル用のカテーテルロック溶液であって、
前記カテーテルロック溶液のpHは7である
ことを特徴とするカテーテルロック溶液。 - 請求項14に記載のカテーテルロック溶液を収容するシリンジを含むことを特徴とするプレフィルドシリンジ。
- 管を含むカテーテルであって、前記管は、前記管を貫く管腔を画定し、前記管腔の少なくとも一部に請求項14に記載のカテーテルロック溶液が注入されていることを特徴とするカテーテル。
- カテーテル中の凝固活性および細菌活性を阻害する方法であって、
管を含むカテーテルであって、前記管は、前記管を貫く管腔を画定するカテーテルを提供する工程と、
前記カテーテルの管腔の少なくとも一部の中に、請求項14に記載のカテーテルロック溶液を注入する工程と
を含むことを特徴とする方法。
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US201762561859P | 2017-09-22 | 2017-09-22 | |
US62/561,859 | 2017-09-22 | ||
PCT/US2018/052186 WO2019060697A1 (en) | 2017-09-22 | 2018-09-21 | 4% TRISODIC CITRATE SOLUTION FOR USE AS A CATHETER LOCK SOLUTION |
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JP2020534106A JP2020534106A (ja) | 2020-11-26 |
JP7138702B2 true JP7138702B2 (ja) | 2022-09-16 |
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US (2) | US11045589B2 (ja) |
EP (1) | EP3684436A1 (ja) |
JP (1) | JP7138702B2 (ja) |
CN (2) | CN115990296A (ja) |
AU (1) | AU2018338194B2 (ja) |
CA (1) | CA3076366C (ja) |
WO (1) | WO2019060697A1 (ja) |
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US11045589B2 (en) * | 2017-09-22 | 2021-06-29 | Becton, Dickinson And Company | 4% trisodium citrate solution for use as a catheter lock solution |
CN117677409A (zh) * | 2021-07-19 | 2024-03-08 | 贝克顿·迪金森公司 | 用作抗微生物导管封管溶液的16%柠檬酸钠溶液 |
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