WO1998034119A1 - Traitement pour surface solide - Google Patents

Traitement pour surface solide Download PDF

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Publication number
WO1998034119A1
WO1998034119A1 PCT/JP1998/000398 JP9800398W WO9834119A1 WO 1998034119 A1 WO1998034119 A1 WO 1998034119A1 JP 9800398 W JP9800398 W JP 9800398W WO 9834119 A1 WO9834119 A1 WO 9834119A1
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WO
WIPO (PCT)
Prior art keywords
solid surface
limulus
reactive substance
surfactant
treating
Prior art date
Application number
PCT/JP1998/000398
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English (en)
Japanese (ja)
Inventor
Hiroshi Tamura
Shigenori Tanaka
Original Assignee
Seikagaku Corporation
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Seikagaku Corporation filed Critical Seikagaku Corporation
Priority to JP53272398A priority Critical patent/JP3825812B2/ja
Publication of WO1998034119A1 publication Critical patent/WO1998034119A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/579—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving limulus lysate

Definitions

  • the present invention relates to endotoxin and / or
  • (1 ⁇ 3) A method for easily and efficiently releasing D-glucan (collectively referred to as “limulus-reactive substance” as defined later), the treating agent used in the method, and the treatment In the measurement of the Limulus reaction by Limulus reaction using the horseshoe crab 'Amebosite' lysate, endotoxin and Z or (1 ⁇ 3) - ⁇ - ⁇ were measured from solid surfaces such as medical devices and medical containers. —Easily and efficiently release glucan, endotoxin and ⁇ or
  • Endotoxin which triggers this reaction, is an outer membrane component of the cell wall of Gram-negative bacteria, also called lipopolysaccharide (LPS), and has amphiphiles in which hydrophilic sugar chains and hydrophobic lipid A moieties are localized in the molecule. Substance.
  • Endotoxin has an exothermic effect even in minute amounts in vivo, and is known to have various biological activities (toxicity) such as induction of free ⁇ shock and lethal effect of inflammatory cytokines such as TNF and IL-11. Must be avoided as much as possible.
  • FDA is 1
  • endotoxin subunits are known to form large molecular aggregates (aggregates) through hydrophobic and ionic bonds, and to form complex micelles with proteins and lipids.
  • This micelle structure greatly affects the Limulus reaction, and there is a molecular size and the micelle structure showing the maximum activity.
  • Endotoxin which is amphiphilic, adsorbs to various substances and carriers via its hydrophilic group and hydrophobic group.
  • plastics have the property of strongly adsorbing under certain conditions. Therefore, the endotoxin adsorbed on the plastic device is not released at all simply by distilled water, but may be released only when it comes into contact with body fluids such as blood.
  • the present invention relates to a hygienic safe and low-cost method capable of easily and efficiently releasing a Limulus-reactive substance adhered or adsorbed to a solid surface of a medical device, a pharmaceutical container or the like, a treating agent used in the method, And a method for measuring limulus-reactive substances using the same. Disclosure of the invention
  • the present invention has the following configurations.
  • the Limulus-reactive substance is a substance that activates a C-factor system or a G-factor system of horseshoe crab, amebosite, and lysate.
  • nonionic surfactant is selected from polyoxyethylene ethers, polyoxyethylene sorbitans, and polyethylene glycol.
  • solid surface according to any one of 1) to 7) above, wherein the solid surface is a surface selected from a synthetic resin, a natural resin, a synthetic fiber, a natural fiber, a metal, and glass. Processing method.
  • a solid surface which is used to release a limulus-reactive substance from a solid surface to which the limulus-reactive substance is attached or adsorbed, and which comprises a chelating agent and / or a surfactant as an active ingredient. Processing agent.
  • the limulus reagent is allowed to act on the treatment solution obtained by treating the solid surface to which the limulus-reactive substance is attached or adsorbed with a treatment agent containing a chelating agent and / or a surfactant as an active ingredient.
  • Characteristic method for measuring Limulus-reactive substances Characteristic method for measuring Limulus-reactive substances.
  • a treatment agent containing a chelating agent and / or a surfactant as an active ingredient A simple and efficient method for treating the surface of medical devices and drug containers of various materials, and attaching and adsorbing the limulus-reactive substance, ie, endotoxin and / or (1 ⁇ 3) - ⁇ -1D-glucan, to or from the surface of equipment It can be liberated well (hereinafter, the treating agent is also referred to as “the treating agent of the present invention”).
  • a Limulus reagent is allowed to act on a treatment solution obtained by treating a solid surface with the treatment agent of the present invention, whereby a Limulus-reactive substance can be accurately measured.
  • the treating agent of the present invention exhibits a long-term stable releasing effect of a Limulus-reactive substance in an aqueous solution.
  • limulus-reactive substance means a substance that acts on a lysate component to induce a Limulus reaction, and includes a C-factor system (including at least C-factor, ⁇ -factor and ⁇ or a coagulase precursor as a component). ) Activates endotoxin and G factor system (including at least factor G and / or coagulase precursor) (1 ⁇ 3) _ — D-glucan.
  • the lysate is prepared by extracting the horseshoe bonnet (blood cell) by a suitable method such as a homogenizer.
  • any reagent can be used as long as it is obtained using a lysate as a raw material.
  • a Limulus reagent include known methods from Limulus polyphemus, tachypres * tridentatus, tachypleus * gigas, tachypleus (carcinoscorpius), londiki uruda, etc., from the blood lymph of the horseshoe. (For example, normal lysate prepared by J. Biochem., 80, 1011-1021 (1976)), and endotoxin-specific lysate excluding factor G reaction.
  • Endotoxin-specific reagents for the synthetic substrate method prepared by further adding a synthetic substrate to these lysates Japanese Patent Publication 2-18080, Japanese Patent Publication 3-18080, Obayashi T. et al. (Obayashi T. et. ), Clini. Chim. Acta, 149, 55-65 (1985)
  • the reaction of C factor were excluded (1-3) — / 3-—D-glucan-specific rice G 4-285859)
  • lysates prepared by adding a synthetic substrate to these lysates (1 ⁇ 3) — _D-glucan-specific reagent Japanese Patent Laid-Open No. 4-285859
  • the assay method of the present invention This method has the advantage that it is highly accurate to perform the reaction using a gel reagent, and there is no need to use a coagulant.
  • the present invention is not limited to this.A gel-forming Limulus reagent or a turbidimetric Limulus reagent applying a gel-forming reaction Can also be performed.
  • the Limulus reaction 'f biomaterial present on the solid surface can be reduced. It can be identified as endotoxin or (1 ⁇ 3) - ⁇ - ⁇ -glucan.
  • the treatment agent of the present invention contains at least one or both of a chelating agent and a surfactant as an active ingredient.
  • the chelating agent that can be used in the present invention is not particularly limited as long as it is a compound that forms a cyclic structure (chelating ring) by coordination to a metal ion, but the molecule has a plurality of oxygen, nitrogen or iodide in the molecule.
  • an organic compound capable of forming a 5- to 6-membered ring structure by coordination is more preferable.
  • citrate ethylenediaminetetraacetic acid (EDTA :), diaminopropanetetraacetic acid (Methy1-EDTA), hydroxyshethylethylenediaminetriacetic acid (EDTA-OH), glycol ether diamine Tetraacetic acid (GEDTA), N, N-bis (2-hydroxybenzyl) ethylendiamine-N, N-diacetic acid (HBED), tri-triacetate (NTA), and ethylene triamine pentaacetic acid (DTPA ) And salts of these compounds (sodium salt, potassium salt, ammonium salt, etc.) and the like, and these can be used alone or in combination.
  • Preferred chelating agents include citric acid, ethylenediaminetetraacetic acid or salts thereof.
  • a nonionic surfactant or an anionic surfactant is preferable.
  • nonionic surfactant polyoxyethylene ethers, polyoxyethylene sorbitans, polyethylene glycol and the like are preferable, and these are used alone or in combination. Further, these nonionic surfactants are particularly effective when used in combination with a chelating agent, for example, ethylenediaminetetraacetic acid or a salt thereof.
  • a chelating agent for example, ethylenediaminetetraacetic acid or a salt thereof.
  • the polyoxyethylene ethers that can be used in the present invention include Trioxy-based polyoxyethylene mono-p-tert-octyl (or isooctyl).
  • Phenyl) phenyl ether (polymerization degree: 8 to 40), polyoxyethylene carboxy (or isooctyl) phenyl ether (polymerization degree: 8 to 40), polyquinethylene: p-nonylphenyl ether (polymerization) Degree 10 to 20) and polyoxyethylene dodecyl ether (polymerization degree 10 to 29) as the Brij series, and these are used alone or in combination.
  • Examples of polyoxyethylene sorbitan include polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan monopalmitate, polyoxyethylene ether monostearate (Tween series), etc. These can be used alone or in combination.
  • polyethylene glycol (PEG) is a polymer of ethylene glycol with an average molecular weight of
  • 2,000 to 20,000 preferably 20,000 to 20,000, more preferably 4,000 to 20,000 These can be used alone or in combination.
  • anionic surfactant examples include alkyl sulfates, cholate salts, and dequincholate salts (preferably, alkali metal salts such as sodium), and the like. Specific examples include sodium dodecyl sulfate (SDS).
  • the solid surface to be treated according to the present invention includes any material that requires confirmation or quantification of the presence or absence of a Limulus-reactive substance, and includes a vacuum blood collection tube, a syringe, an infusion connection tube, and a hollow fiber type.
  • Examples include surfaces of medical devices such as module membranes for artificial dialysis, module membranes for plasma exchange, blood circuits and the like, but are not limited thereto, and include, for example, surfaces of food and beverage containers and the like. Therefore, the material for the solid surface includes any material as long as the material cannot be used due to dissolution, deformation or the like with the treatment agent of the present invention.
  • the treatment liquid from which the limulus-reactive substance has been released according to the present invention is strongly checked for its presence or amount by subjecting it to the Limulus reaction, and is discarded or generalized without subjecting the treatment liquid to the Limulus reaction. I can't wait to say that it can be transferred to water treatment facilities. That is, the present invention may have only a function as a cleaning agent for simply removing a limulus-reactive substance that has a harmful effect on a human body or the like from a solid surface.
  • solid surface materials include synthetic resins, natural resins, synthetic fibers, and natural fibers.
  • examples include fiber, metal, glass and the like, which may be used alone or in combination.
  • synthetic resins composed of polypropylene, polystyrene, polyethylene, polyvinyl chloride, phenol resin, melamine resin, urea resin, gen-based rubber, olefin-based rubber, polyurethane rubber, silicone rubber, fluorine rubber, polysulfide rubber, etc.
  • Synthetic fiber natural resin such as gum arabic, cashmere rubber, ammonia rubber, natural rubber
  • Natural fibers such as cotton, kapok, flax, ramie, manila hemp, wool, mohair, silk, asbestos; metals such as stainless steel copper, silver, gold, platinum, iron, nickel, chromium; soft iron glass, potash glass, hard secondary Hard primary, tungsten, glass, quartz glass, and the like.
  • the treatment agent of the present invention is not particularly limited in its form as long as it contains at least a chelating agent and Z or a surfactant as an active ingredient. And preferably an aqueous solution.
  • Water is usually used as a solvent for the active ingredient, but an organic solvent that does not affect the Limulus reaction can be used in combination with water or alone.
  • the solvent when the treatment liquid in which the limulus-reactive substance is released from the solid surface according to the present invention is subjected to the limulus reaction, the solvent must not contain the limulus-reactive substance.
  • there is no solvent there is no particular limitation, and the quality of the solvent may be selected according to the purpose.
  • the concentration of the chelating agent varies depending on the type thereof, but is preferably in the range of 0.1 mM to 20 mM, more preferably in the range of 0.1 mM to 5 mM.
  • the concentration of the surfactant may vary depending on the type of the chelating agent as well as the chelating agent, preferably in the range of 0.001% to 0.5% (weight Z volume), and more preferably 0.000%. It is in the range of 1 to 0.05% (weight Z capacity).
  • the treating agent of the present invention can also be used in combination with a disinfectant such as sodium hypochlorite. That is, a solid surface can be treated by adding a bactericide to the treating agent of the present invention, or by using a treating agent of the present invention and a bactericide successively.
  • a solid surface can be treated by adding a bactericide to the treating agent of the present invention, or by using a treating agent of the present invention and a bactericide successively.
  • the germicide is a substance that affects the Limulus reaction
  • the contact temperature is 4 to 50 ° C, particularly preferably 10 to 30 ° C
  • the contact time is 5 minutes to 2 hours, particularly 30 minutes to 1 hour. Time ranges are preferred.
  • the method of the contact treatment is not particularly limited, and examples thereof include a shaking treatment, a stirring treatment, and a stationary treatment.
  • the treatment time is appropriately selected depending on the treatment method.
  • the Limulus-reactive substance adhering or adsorbing to the solid surface is easily and efficiently quantitatively released without impairing its activity, and a treatment liquid containing the substance is obtained.
  • the Limulus reagent is mixed with the Limulus reagent, and the Limulus-reactive substance can be accurately measured by a conventional method.
  • INDUSTRIAL APPLICABILITY According to the present invention, it is possible to carry out a more appropriate safety evaluation test of a medical device, a medical container, and the like, thereby greatly contributing to progress in medical treatment and the like.
  • a safe solid surface free from or having a very small amount of limulus-reactive substance can be provided.
  • the remaining treating agent of the present invention is optionally removed with water or the like to provide a solid surface free of the treating agent of the present invention and the Limulus-reactive substance. can do.
  • the number of times of such treatment with the treatment agent of the present invention can be appropriately selected depending on the purpose.
  • FIG. 1 is a diagram for explaining the Limulus reaction. BEST MODE FOR CARRYING OUT THE INVENTION
  • JP Endotoxin (E. c 0 1 i UKT-B, control 891 7) Dilute 10 000 EU / mL to 1.0 EU / mL with distilled water, and add 2 m L is a Falcon tube 209 6 (made of polypropylene, Becton Ditzkinson) and an assist tube No. 5.55.4 7 (made of polystyrene, ASIC Was shaken at room temperature for 3 hours with a micromixer MT (Taitec) and washed thoroughly with distilled water to prepare an endotoxin adsorption tube.
  • a Falcon tube 209 6 made of polypropylene, Becton Ditzkinson
  • an assist tube No. 5.55.4 7 made of polystyrene, ASIC was shaken at room temperature for 3 hours with a micromixer MT (Taitec) and washed thoroughly with distilled water to prepare an endotoxin adsorption tube.
  • distilled water control
  • 0.1% human serum albumin comparative example
  • various treating agents of the present invention containing a chelating agent and / or polyethylene glycol (PEG) # 600
  • a micromixer MT for 1 hour.
  • 50 L of the treated solution add 50 L of endotoxin (Seikagaku Corporation), which is an endotoxin-specific limulus reagent, and use Perleader SK601 (Seikagaku Corporation) to produce rice. Tick Atsushi (37 ° C, 30 minutes) was performed, and the endotoxin concentration was calculated automatically.
  • the concentration in parentheses indicates the final concentration of the treating agent at the time of treatment.
  • chelating agents that form a cyclic structure with metal ions all have a significant endotoxin releasing effect from the solid surface
  • Distilled water (control), 0.1% 7-globulin (comparative example), and the treating agent of the present invention (containing a surfactant or Z and EDTA-4Na) were added to the endotoxin adsorption tube used in Example 1. 2 mL each was added, and the mixture was shaken with a micromixer MT at room temperature for 1 hour. To 50 L of the treated solution, 50 zL of endosperm was added, and the measurement was performed in the same manner as in Example 1 to calculate the endotoxin concentration. Assuming that the theoretical value of adsorbed endotoxin (addition amount-detection amount in washing water) was 100%, the release effect index (%) of endotoxin in each treatment solution was calculated (Table 2). In Table 2, the concentration of each component of the mixed solution with PEG indicates the concentration after mixing.
  • the concentration in parentheses indicates the final concentration of the treating agent at the time of treatment.
  • EDTA-4 Na was added to the endotoxin adsorption tube used in Example 1.
  • PEG # 600 0.5 mM, 0.004%, respectively 21: each and then added using a micromixer MT4. C, 10 and shaking at 25 ° C, 30 ° C, 37 ° C, 50 ° C for 1 hour.
  • 5 OjtL of endosperm was added, and the measurement was carried out in the same manner as in Example 1 to calculate the endotoxin concentration. Assuming that the theoretical value of adsorbed endotoxin (addition amount-detection amount in washing water) was 100%, the release effect index (%) of endotoxin in each treatment solution was calculated (Table 3).
  • Example 4 The same treatment was performed using instruments and medical tools of the same mouth as the product used in Example 4, and the treated solution was subjected to 50 ⁇ (1 ⁇ 3) — — D-glucan-specific limulus. 5 reagents, Glucose (Seikagaku Corporation) were added.
  • sample preparation for the exothermic test of medical devices is performed under mild extraction conditions for endotoxin, and extraction under relatively severe conditions for chemical pyrogens. Methods for increasing efficiency are known. Minimum extraction time is 15 minutes at 37 ° C, 1 hour at room temperature (> 18 ° C), or other proven elution conditions for Limulus testing of medical devices according to FDA guidelines. It is stipulated that the conditions are equivalent.
  • Example 3 it is clear that even if the plastic appliances were extracted under the above conditions, no extraction effect was observed. In addition, even in the case of using HSA diaglobulin, the effect is extremely inadequate, and there is a risk of contamination with pathogenic microorganisms.
  • the present invention provides a treating agent for releasing a limulus-reactive substance from a solid surface to which the limulus-reactive substance is attached or adsorbed.
  • contamination of limulus-reactive substances in sterile instruments and medical devices particularly potential endotoxins and / or (1 ⁇ 3) 13-D strongly bound to materials that cannot be detected by ordinary extraction methods.
  • the glucan contamination can be grasped more appropriately, and a safe and simple safety evaluation test of the utensil can be performed. As a result, safer medical practices can be achieved, leading to improved medical quality.

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Abstract

L'invention concerne, (1), un procédé de traitement de surface solide, caractérisé par l'utilisation d'un traitement renfermant un agent chélateur et/ou un tensioactif en tant qu'ingrédients actifs entrant en contact avec une surface solide porteuse d'une substance de Limulus réactive déposée ou adsorbée afin, par ce moyen, d'extraire ladite substance, (2), un traitement pour surface solide à utiliser pour extraire une substance de Limulus réactive d'une surface solide porteuse de cette substance déposée ou adsorbée, caractérisé par la présence d'un agent chélateur et/ou d'un tensioactif en tant qu'ingrédient actif, (3), l'utilisation d'un traitement renfermant un agent chélateur et/ou un tensioactif en tant qu'ingrédient actif aux fins de l'extraction d'une substance de Limulus réactive d'une surface solide porteuse de ladite substance déposée ou adsorbée et, (4), un procédé bioanalytique d'une substance de Limulus réactive se caractérisant par le fait qu'il permet à un réactif de Limulus d'agir sur une solution obtenue par traitement d'une surface solide porteuse d'une substance de Limulus réactive déposée ou adsorbée et ce, au moyen d'un traitement renfermant un agent chélateur et/ou un tensioactif en tant qu'ingrédient actif. Ce procédé permet, de manière simple et efficace, d'extraire une substance de Limulus réactive de la surface d'un solide, un dispositif médical ou un contenant pour médicaments, notamment, de façon hygiénique et peu coûteuse.
PCT/JP1998/000398 1997-01-31 1998-01-30 Traitement pour surface solide WO1998034119A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP53272398A JP3825812B2 (ja) 1997-01-31 1998-01-30 固体表面の処理剤

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Application Number Priority Date Filing Date Title
JP1895097 1997-01-31
JP9/18950 1997-01-31

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WO1998034119A1 true WO1998034119A1 (fr) 1998-08-06

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2005062056A1 (ja) * 2003-12-22 2007-07-12 生化学工業株式会社 リポアラビノマンナンの測定方法とその応用
JP2009133627A (ja) * 2007-10-29 2009-06-18 Hoya Corp リン酸カルシウム系化合物、リン酸カルシウム系化合物／コラーゲン複合体及びリン酸カルシウム系細胞培養担体に付着又は吸着したエンドトキシンの抽出方法及び定量方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04135559A (ja) * 1990-09-26 1992-05-11 Akira Nakajima 人工透析の医療機器の消毒洗浄剤
JPH0875751A (ja) * 1994-06-30 1996-03-22 Seikagaku Kogyo Co Ltd エンドトキシン安定化剤、エンドトキシン組成物およびエンドトキシンの測定法
JPH08336589A (ja) * 1995-04-14 1996-12-24 Noriaki Tanaka 血液透析装置の洗浄消毒方法及び洗浄消毒剤

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04135559A (ja) * 1990-09-26 1992-05-11 Akira Nakajima 人工透析の医療機器の消毒洗浄剤
JPH0875751A (ja) * 1994-06-30 1996-03-22 Seikagaku Kogyo Co Ltd エンドトキシン安定化剤、エンドトキシン組成物およびエンドトキシンの測定法
JPH08336589A (ja) * 1995-04-14 1996-12-24 Noriaki Tanaka 血液透析装置の洗浄消毒方法及び洗浄消毒剤

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2005062056A1 (ja) * 2003-12-22 2007-07-12 生化学工業株式会社 リポアラビノマンナンの測定方法とその応用
US7851179B2 (en) 2003-12-22 2010-12-14 Seikagaku Corporation Method of measuring lipoarabinomannan and application thereof
JP4637750B2 (ja) * 2003-12-22 2011-02-23 生化学工業株式会社 リポアラビノマンナンの測定方法とその応用
US8703412B2 (en) 2003-12-22 2014-04-22 Seikagaku Corporation Method of measuring lipoarabinomannan and application thereof
JP2009133627A (ja) * 2007-10-29 2009-06-18 Hoya Corp リン酸カルシウム系化合物、リン酸カルシウム系化合物／コラーゲン複合体及びリン酸カルシウム系細胞培養担体に付着又は吸着したエンドトキシンの抽出方法及び定量方法

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