CN101426539A - 抗微生物组合物和锁定导管的方法 - Google Patents
抗微生物组合物和锁定导管的方法 Download PDFInfo
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- CN101426539A CN101426539A CNA2007800138772A CN200780013877A CN101426539A CN 101426539 A CN101426539 A CN 101426539A CN A2007800138772 A CNA2007800138772 A CN A2007800138772A CN 200780013877 A CN200780013877 A CN 200780013877A CN 101426539 A CN101426539 A CN 101426539A
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- Prior art keywords
- antimicrobial compositions
- acid
- poloxamer
- alcohol
- salt
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- 239000000203 mixture Substances 0.000 title claims abstract description 133
- 230000000845 anti-microbial effect Effects 0.000 title claims abstract description 117
- 238000000034 method Methods 0.000 title claims abstract description 22
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 59
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims abstract description 53
- 229920001983 poloxamer Polymers 0.000 claims abstract description 48
- 239000003139 biocide Substances 0.000 claims abstract description 46
- 229960000502 poloxamer Drugs 0.000 claims abstract description 44
- 230000003115 biocidal effect Effects 0.000 claims description 44
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 43
- -1 5-nitro-2-furfural semicarbazones Chemical class 0.000 claims description 32
- 238000000576 coating method Methods 0.000 claims description 17
- 229910052757 nitrogen Inorganic materials 0.000 claims description 17
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims description 16
- 239000002253 acid Substances 0.000 claims description 14
- 239000003146 anticoagulant agent Substances 0.000 claims description 14
- 229940127219 anticoagulant drug Drugs 0.000 claims description 14
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 12
- 239000011248 coating agent Substances 0.000 claims description 12
- 229920000642 polymer Polymers 0.000 claims description 11
- GHXZTYHSJHQHIJ-UHFFFAOYSA-N Chlorhexidine Chemical compound C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 GHXZTYHSJHQHIJ-UHFFFAOYSA-N 0.000 claims description 10
- RGHNJXZEOKUKBD-SQOUGZDYSA-N Gluconic acid Natural products OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 claims description 10
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims description 10
- JUJWROOIHBZHMG-UHFFFAOYSA-N Pyridine Chemical compound C1=CC=NC=C1 JUJWROOIHBZHMG-UHFFFAOYSA-N 0.000 claims description 10
- 229960003260 chlorhexidine Drugs 0.000 claims description 10
- 229960002897 heparin Drugs 0.000 claims description 10
- 229920000669 heparin Polymers 0.000 claims description 10
- 238000002513 implantation Methods 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 230000001476 alcoholic effect Effects 0.000 claims description 9
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 9
- 229910052760 oxygen Inorganic materials 0.000 claims description 9
- RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 claims description 8
- 239000000645 desinfectant Substances 0.000 claims description 8
- 239000000174 gluconic acid Substances 0.000 claims description 8
- 235000012208 gluconic acid Nutrition 0.000 claims description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 7
- MCJGNVYPOGVAJF-UHFFFAOYSA-N quinolin-8-ol Chemical compound C1=CN=C2C(O)=CC=CC2=C1 MCJGNVYPOGVAJF-UHFFFAOYSA-N 0.000 claims description 7
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims description 6
- 239000005977 Ethylene Substances 0.000 claims description 6
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims description 6
- SMWDFEZZVXVKRB-UHFFFAOYSA-N Quinoline Chemical compound N1=CC=CC2=CC=CC=C21 SMWDFEZZVXVKRB-UHFFFAOYSA-N 0.000 claims description 6
- 108090000373 Tissue Plasminogen Activator Proteins 0.000 claims description 6
- 102000003978 Tissue Plasminogen Activator Human genes 0.000 claims description 6
- 229960002152 chlorhexidine acetate Drugs 0.000 claims description 6
- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 claims description 6
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 claims description 6
- MCSINKKTEDDPNK-UHFFFAOYSA-N propyl propionate Chemical compound CCCOC(=O)CC MCSINKKTEDDPNK-UHFFFAOYSA-N 0.000 claims description 6
- 229960000187 tissue plasminogen activator Drugs 0.000 claims description 6
- YRIZYWQGELRKNT-UHFFFAOYSA-N 1,3,5-trichloro-1,3,5-triazinane-2,4,6-trione Chemical compound ClN1C(=O)N(Cl)C(=O)N(Cl)C1=O YRIZYWQGELRKNT-UHFFFAOYSA-N 0.000 claims description 5
- 238000005660 chlorination reaction Methods 0.000 claims description 5
- 229920001993 poloxamer 188 Polymers 0.000 claims description 5
- UMJSCPRVCHMLSP-UHFFFAOYSA-N pyridine Natural products COC1=CC=CN=C1 UMJSCPRVCHMLSP-UHFFFAOYSA-N 0.000 claims description 5
- 239000011780 sodium chloride Substances 0.000 claims description 5
- 229950009390 symclosene Drugs 0.000 claims description 5
- FYZXEMANQYHCFX-UHFFFAOYSA-K tripotassium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxymethyl)amino]acetate Chemical compound [K+].[K+].[K+].OC(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O FYZXEMANQYHCFX-UHFFFAOYSA-K 0.000 claims description 5
- KEQGZUUPPQEDPF-UHFFFAOYSA-N 1,3-dichloro-5,5-dimethylimidazolidine-2,4-dione Chemical compound CC1(C)N(Cl)C(=O)N(Cl)C1=O KEQGZUUPPQEDPF-UHFFFAOYSA-N 0.000 claims description 4
- OSDLLIBGSJNGJE-UHFFFAOYSA-N 4-chloro-3,5-dimethylphenol Chemical compound CC1=CC(O)=CC(C)=C1Cl OSDLLIBGSJNGJE-UHFFFAOYSA-N 0.000 claims description 4
- CFKMVGJGLGKFKI-UHFFFAOYSA-N 4-chloro-m-cresol Chemical compound CC1=CC(O)=CC=C1Cl CFKMVGJGLGKFKI-UHFFFAOYSA-N 0.000 claims description 4
- 229930185605 Bisphenol Natural products 0.000 claims description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 4
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 claims description 4
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims description 4
- 229930040373 Paraformaldehyde Natural products 0.000 claims description 4
- KFSLWBXXFJQRDL-UHFFFAOYSA-N Peracetic acid Chemical compound CC(=O)OO KFSLWBXXFJQRDL-UHFFFAOYSA-N 0.000 claims description 4
- 229920002511 Poloxamer 237 Polymers 0.000 claims description 4
- XEFQLINVKFYRCS-UHFFFAOYSA-N Triclosan Chemical compound OC1=CC(Cl)=CC=C1OC1=CC=C(Cl)C=C1Cl XEFQLINVKFYRCS-UHFFFAOYSA-N 0.000 claims description 4
- DZBUGLKDJFMEHC-UHFFFAOYSA-N acridine Chemical compound C1=CC=CC2=CC3=CC=CC=C3N=C21 DZBUGLKDJFMEHC-UHFFFAOYSA-N 0.000 claims description 4
- 239000000654 additive Substances 0.000 claims description 4
- 230000000996 additive effect Effects 0.000 claims description 4
- JACTTWVLMNPJQA-UHFFFAOYSA-N azane;quinoline Chemical compound N.N1=CC=CC2=CC=CC=C21 JACTTWVLMNPJQA-UHFFFAOYSA-N 0.000 claims description 4
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 4
- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 claims description 4
- 229960001950 benzethonium chloride Drugs 0.000 claims description 4
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 4
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 4
- VEZXCJBBBCKRPI-UHFFFAOYSA-N beta-propiolactone Chemical group O=C1CCO1 VEZXCJBBBCKRPI-UHFFFAOYSA-N 0.000 claims description 4
- 239000000460 chlorine Substances 0.000 claims description 4
- 229910052801 chlorine Inorganic materials 0.000 claims description 4
- 229960005443 chloroxylenol Drugs 0.000 claims description 4
- VKYKSIONXSXAKP-UHFFFAOYSA-N hexamethylenetetramine Chemical compound C1N(C2)CN3CN1CN2C3 VKYKSIONXSXAKP-UHFFFAOYSA-N 0.000 claims description 4
- WQYVRQLZKVEZGA-UHFFFAOYSA-N hypochlorite Chemical compound Cl[O-] WQYVRQLZKVEZGA-UHFFFAOYSA-N 0.000 claims description 4
- JLMHZVYLAQPMOZ-UHFFFAOYSA-N noxytiolin Chemical compound CNC(=S)NCO JLMHZVYLAQPMOZ-UHFFFAOYSA-N 0.000 claims description 4
- 229960001194 noxytiolin Drugs 0.000 claims description 4
- 229920002866 paraformaldehyde Polymers 0.000 claims description 4
- DGTNSSLYPYDJGL-UHFFFAOYSA-N phenyl isocyanate Chemical compound O=C=NC1=CC=CC=C1 DGTNSSLYPYDJGL-UHFFFAOYSA-N 0.000 claims description 4
- 229940044519 poloxamer 188 Drugs 0.000 claims description 4
- 229920001992 poloxamer 407 Polymers 0.000 claims description 4
- 229940044476 poloxamer 407 Drugs 0.000 claims description 4
- 229960000380 propiolactone Drugs 0.000 claims description 4
- 125000001453 quaternary ammonium group Chemical group 0.000 claims description 4
- SQGYOTSLMSWVJD-UHFFFAOYSA-N silver(1+) nitrate Chemical compound [Ag+].[O-]N(=O)=O SQGYOTSLMSWVJD-UHFFFAOYSA-N 0.000 claims description 4
- AJKIRUJIDFJUKJ-UHFFFAOYSA-N taurolidine Chemical compound C1NS(=O)(=O)CCN1CN1CNS(=O)(=O)CC1 AJKIRUJIDFJUKJ-UHFFFAOYSA-N 0.000 claims description 4
- 229960004267 taurolidine Drugs 0.000 claims description 4
- MGSRCZKZVOBKFT-UHFFFAOYSA-N thymol Chemical compound CC(C)C1=CC=C(C)C=C1O MGSRCZKZVOBKFT-UHFFFAOYSA-N 0.000 claims description 4
- 229950001807 tribromsalan Drugs 0.000 claims description 4
- 229960003500 triclosan Drugs 0.000 claims description 4
- AZQWKYJCGOJGHM-UHFFFAOYSA-N 1,4-benzoquinone Chemical compound O=C1C=CC(=O)C=C1 AZQWKYJCGOJGHM-UHFFFAOYSA-N 0.000 claims description 3
- 125000000022 2-aminoethyl group Chemical group [H]C([*])([H])C([H])([H])N([H])[H] 0.000 claims description 3
- GOLORTLGFDVFDW-UHFFFAOYSA-N 3-(1h-benzimidazol-2-yl)-7-(diethylamino)chromen-2-one Chemical compound C1=CC=C2NC(C3=CC4=CC=C(C=C4OC3=O)N(CC)CC)=NC2=C1 GOLORTLGFDVFDW-UHFFFAOYSA-N 0.000 claims description 3
- 102000004411 Antithrombin III Human genes 0.000 claims description 3
- 108090000935 Antithrombin III Proteins 0.000 claims description 3
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical group CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 claims description 3
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 3
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims description 3
- QZKRHPLGUJDVAR-UHFFFAOYSA-K EDTA trisodium salt Chemical compound [Na+].[Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O QZKRHPLGUJDVAR-UHFFFAOYSA-K 0.000 claims description 3
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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims description 3
- 102000007327 Protamines Human genes 0.000 claims description 3
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- 101800004937 Protein C Proteins 0.000 claims description 3
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- 108010066124 Protein S Proteins 0.000 claims description 3
- 101800001700 Saposin-D Proteins 0.000 claims description 3
- 239000005708 Sodium hypochlorite Substances 0.000 claims description 3
- 108010023197 Streptokinase Proteins 0.000 claims description 3
- 108090000435 Urokinase-type plasminogen activator Proteins 0.000 claims description 3
- 102000003990 Urokinase-type plasminogen activator Human genes 0.000 claims description 3
- 229960002054 acenocoumarol Drugs 0.000 claims description 3
- VABCILAOYCMVPS-UHFFFAOYSA-N acenocoumarol Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=C([N+]([O-])=O)C=C1 VABCILAOYCMVPS-UHFFFAOYSA-N 0.000 claims description 3
- 229960001138 acetylsalicylic acid Drugs 0.000 claims description 3
- 229960005348 antithrombin iii Drugs 0.000 claims description 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 3
- NGPGDYLVALNKEG-UHFFFAOYSA-N azanium;azane;2,3,4-trihydroxy-4-oxobutanoate Chemical compound [NH4+].[NH4+].[O-]C(=O)C(O)C(O)C([O-])=O NGPGDYLVALNKEG-UHFFFAOYSA-N 0.000 claims description 3
- 229960001500 bivalirudin Drugs 0.000 claims description 3
- OIRCOABEOLEUMC-GEJPAHFPSA-N bivalirudin Chemical compound C([C@@H](C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CC(C)C)C(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 OIRCOABEOLEUMC-GEJPAHFPSA-N 0.000 claims description 3
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- KLOIYEQEVSIOOO-UHFFFAOYSA-N carbocromen Chemical compound CC1=C(CCN(CC)CC)C(=O)OC2=CC(OCC(=O)OCC)=CC=C21 KLOIYEQEVSIOOO-UHFFFAOYSA-N 0.000 claims description 3
- CEYULKASIQJZGP-UHFFFAOYSA-L disodium;2-(carboxymethyl)-2-hydroxybutanedioate Chemical compound [Na+].[Na+].[O-]C(=O)CC(O)(C(=O)O)CC([O-])=O CEYULKASIQJZGP-UHFFFAOYSA-L 0.000 claims description 3
- WQPDUTSPKFMPDP-OUMQNGNKSA-N hirudin Chemical compound C([C@@H](C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C=CC(OS(O)(=O)=O)=CC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CCCCN)NC(=O)[C@H]1N(CCC1)C(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@H]1NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CC(C)C)NC(=O)[C@H]([C@@H](C)CC)NC(=O)[C@@H]2CSSC[C@@H](C(=O)N[C@@H](CCC(O)=O)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(=O)N[C@H](C(NCC(=O)N[C@@H](CCC(N)=O)C(=O)NCC(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCCCN)C(=O)N2)=O)CSSC1)C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H]1NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=2C=CC(O)=CC=2)NC(=O)[C@@H](NC(=O)[C@@H](N)C(C)C)C(C)C)[C@@H](C)O)CSSC1)C(C)C)[C@@H](C)O)[C@@H](C)O)C1=CC=CC=C1 WQPDUTSPKFMPDP-OUMQNGNKSA-N 0.000 claims description 3
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- MGFYIUFZLHCRTH-UHFFFAOYSA-N nitrilotriacetic acid Chemical compound OC(=O)CN(CC(O)=O)CC(O)=O MGFYIUFZLHCRTH-UHFFFAOYSA-N 0.000 claims description 3
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- DQDAYGNAKTZFIW-UHFFFAOYSA-N phenprocoumon Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC)C1=CC=CC=C1 DQDAYGNAKTZFIW-UHFFFAOYSA-N 0.000 claims description 3
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- VZOPRCCTKLAGPN-ZFJVMAEJSA-L potassium;sodium;(2r,3r)-2,3-dihydroxybutanedioate;tetrahydrate Chemical compound O.O.O.O.[Na+].[K+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O VZOPRCCTKLAGPN-ZFJVMAEJSA-L 0.000 claims description 3
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- WPYJKGWLDJECQD-UHFFFAOYSA-N quinoline-2-carbaldehyde Chemical compound C1=CC=CC2=NC(C=O)=CC=C21 WPYJKGWLDJECQD-UHFFFAOYSA-N 0.000 claims description 3
- WKEDVNSFRWHDNR-UHFFFAOYSA-N salicylanilide Chemical compound OC1=CC=CC=C1C(=O)NC1=CC=CC=C1 WKEDVNSFRWHDNR-UHFFFAOYSA-N 0.000 claims description 3
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Abstract
提供了用于锁定导管和其它装置的抗微生物组合物。在某些实施方案中,该组合物包括至少一种醇,至少一种不为醇的杀生物剂和一种或多种泊洛沙姆;在其它实施方案中,该组合物包含至少一种泊洛沙姆和至少一种醇。该组合物可以提供长效抗微生物活性。还提供了使用该组合物的方法。
Description
相关申请的交叉参考
本申请请求2006年2月28日提交的临时申请号60/777,382的优先权。
发明领域
本发明一般涉及抗微生物组合物,这些组合物可以用于导管锁定溶液或导管涂层以便减轻或预防感染。
发明背景
导管,特别是静脉内(IV)导管用于将流体(诸如盐水溶液,各种药物和非肠道营养物)输注入患者,从患者中抽取血液并且监测患者血管系统的各种参数。一般而言,导管包括含注入或调配入患者体内的流体或药物的腔或储器和用于通入针头的注射口或装置。
与导管相关的并发症包括与其插入相关的那些,诸如肺/血胸,动脉穿剌和神经损伤和作为其应用结果发生的继发性问题,诸如血栓形成和感染。如果导管受到污染,那么患者需要额外的治疗并且可能要除去导管。就经皮导管而言,皮肤穿透是通常的感染途经。导管脓毒症仍然是接受家庭胃肠外营养的患者发病率和死亡率的主要原因之一。植入导管通常可能随时间变阻塞或污染。这是使用血管内导管的问题,其中在导管腔内凝固和血栓形成可成为问题。
大部分严重的导管相关的感染与中心静脉导管(CVCs)相关,尤其是放入在重症监护室(ICUs)中的患者的那些。在ICU环境中,感染的发生率通常高于亚急性住院病人或不卧床中的感染。每天可以多次进入某些导管(例如肺动脉导管和外周动脉导管)进行血液动力学测定或获得实验室分析用样品,从而增加了污染和随后临床感染的可能性。据估计每年出现总计250,000个CVC-相关血流感染(BSIs)病例并且CVC-相关BSI成本就发病率和花费的财政资源而言非常高。
为了减少与凝固和血栓形成相关的问题,目前通常"锁定"连续应用之间的血管内通路导管。锁定一般包括首先用盐水冲洗导管以便除去血液和来自导管腔的其它物质。在冲洗导管后,随即注射抗凝溶液,一般为肝素以替换盐水并且填充腔。肝素锁定溶液防止血液进入腔并且主动抑制腔内的凝固和血栓形成。尽管某些血栓仍然在导管远端尖端形成,但是这种形成通常最少并且几乎不存在问题。进一步提出了将各种抗微生物物质与锁定溶液合并以便在抑制血栓形成的同时抑制感染。
尽管一般是有效的,但是肝素在导管锁定溶液中的应用存在许多缺点。在每次导管治疗期结束时制备肝素溶液的要求是耗时的并且提供了看护者犯错误的机会。血液透析和血液滤过患者可以每周进行至少几次这类肝素锁定,而使用IV的患者每天必须进行几次这类肝素锁定。进行肝素锁定的不便利性和花费可能随时间而成为负担。此外,在肝素锁定溶液中合并单独的抗微生物剂的要求进一步使程序复杂化并且添加了花费,并且将抗微生物剂添加到肝素锁定中一般仅在腔内和来自腔内开口上有效。在植入导管周围区中的感染风险几乎没有降低,包括通过皮肤的穿透点,此处感染风险最大。已经设计了某些锁定溶液来克服这一问题并且可穿透导管材料以便在导管周围组织中提供抗微生物作用。
美国专利US6,592,564中描述了低级醇类在消毒植入导管中的应用。醇扩散通过导管或其它植入装置的多孔材料,由此对周围组织以及装置内部提供抗微生物活性。
醇类在其消毒特性方面为众所周知的。包含70%乙醇和30%水的擦洗用酒精和包含70%异丙醇和30%水的擦洗用异丙基酒精作为消毒剂分别列在美国药典(USP)法定专著XXIV,60和927页上。近期公布的研究表明醇为有效的抗微生物剂并且如果以手术擦洗使用,那么会引起细菌计数的平均log明显下降。
美国专利US 6,350,251中披露了体内假肢器官装置,诸如包括杀生物锁的导管或开口,所述的杀生物锁包含抗凝剂和非抗生素类杀生物剂。
在基于醇的现有技术组合物中,醇极为快速地挥发或变稀并且无法提供长效抗微生物活性。这导致在使用导管间期的时间较长时需要重复冲洗导管并且更新抗微生物组合物。仍然需要抗微生物锁定溶液,它可以提供长效作用,无需在使用导管间期额外施用。
发明概述
本发明在某些实施方案中提供了抗微生物组合物或导管涂层,其包含至少一种泊洛沙姆,占所述抗微生物组合物总重至少10%重量的至少一种醇和至少一种不为醇的杀生物剂。本发明在其它实施方案中提供了抗微生物组合物或导管涂层,其包含至少一种泊洛沙姆和占所述抗微生物组合物总重至少10%重量的至少一种醇。
本发明在某些实施方案中提供了使用上述抗微生物组合物涂敷导管的至少部分内表面的方法。
本发明在某些实施方案中提供了提供用于消毒导管的方法,包括将抗微生物组合物导入导管腔或用抗微生物组合物涂敷导管的至少部分内部,所述的抗微生物溶液包含至少一种醇,至少一种不为醇的杀生物剂和至少一种泊洛沙姆。本发明在其它实施方案中提供了用于消毒导管的方法,包括将抗微生物组合物导入导管腔或用抗微生物组合物涂敷导管的至少部分内部,所述的抗微生物组合物包含至少一种醇和至少一种泊洛沙姆。
本发明的这些和其它方面更易于从下列详细描述和待批权利要求中显而易见。
发明详述
导管为卫生保健人员可以插入身体部分的管。在大部分应用中,它为细的柔性管:“软”导管;在某些情况中,它为较大的实体管:“硬”导管。例如,将导管放入身体特定部分,例如导尿管插入术能够从膀胱中排出尿;排出流体收集物,例如腹部脓肿;给予静脉内流体,药物或非肠道营养物;血管成形术,血管造影术,气囊间隔造口术;和动脉或静脉内的血压直接测量。此外,植入的导管适合广泛用于许多医疗操作。血液透析和血液滤过均依赖于单独的抽取和返回植入静脉的导管以便能够对血液进行体外处理。相反,腹膜透析依赖于植入腹膜的单一导管以便能够导入和抽取透析液而在原位透析。
存在许多类型的用于静脉内给予流体和药物的导管,包括外周小静脉导管(PVC);外周动脉导管;中线导管;非隧道式中心静脉导管(CVC);肺动脉导管;经皮插入的中心导管(PICC);隧道式导管;可完全植入的导管;和脐导管。
IV导管的最常见插入部位为在臂中的静脉(外周静脉,由此称作"外周静脉导管"(PVC))。外周静脉为不在胸或腹部中的任何静脉。一般使用臂和手静脉,不过,偶然也使用腿和足静脉。儿科医生有时使用婴儿的头皮静脉。这类IV疗法通常保持就位2-3天,此后需要除去或改变至不同部位。外周IV线路由通过皮肤插入外周静脉的短导管(几厘米长)组成。导管的部分仍然保持在具有插孔的皮肤外部,所述的插孔可以与注射器或静脉内输注线路连接或在治疗之间用塞封闭。通常按标准规格显示导管口径,其中14号为极大的导管(用于复苏术环境)且24-26号为最小。如果必要,可以从外周IV中抽取血液,但唯一的条件是它在相对大的静脉中并且唯一的条件是新近插入IV。外周IV不能不确定地遗留在静脉内,这是因导致蜂窝织炎和菌血症的插入部位感染风险所致。医院的政策通常表明每隔3天更换每一外周IV(在不同位置)以避免这种并发症。
在患者需要使用IV较长期治疗的情况中,将导管插入较大静脉,其通常接近肩(锁骨下静脉)或颈(颈静脉)。这些类型的称作“中心静脉导管”(CVC)的导管伸展入心脏尖端(上腔静脉)以便在给予药物和流体中更直接和快速地进入血流,并且可以保持就位达7天。可以将需要保持就位几周的中心静脉导管植入皮下(隧道化)并且定位于大静脉,其中理想的导管离开在患者胸部上的皮肤。中心IV线路具有超过外周IV的几个优点。它可以递送因其浓度或化学组成而可能过度刺激外周静脉的流体和药物,诸如某些化疗药和完全非肠道营养物。药物即刻达到心脏并且快速分布在身体的剩余部分。在导管内存在多个平行隔室(腔)的室,使得可以递送多种尽管它们可能在单一管内不具有化学相容性的药物。医疗护理提供者可以通过所述的线路测定中心静脉压和其它生理学变量。然而,中心IV线路也具有出血,菌血症和气体栓塞的高度风险。
还可以将长期中心静脉导管插入肘,即肘窝前部大静脉,然后使其伸展入上腔静脉。这类导管称作外周插入的中心导管或PICC,并且可以停留在同一静脉内几周。PICCs为家庭护理患者的IV疗法的最常见形式。PICC导管常用于医院环境(紧急医护),诸重症监护室和临危护理,也广泛应用于家庭护理环境并且通常指示用于需要长期疗法(几周-数月)的患者。
最常见类型的IV导管为针外外周IV导管。如其名称所表示的含义,将针外IV导管固定在具有尖锐的远端尖端的导入针头上。至少该导管的远端部分紧密衔接针的外表面以防止导管回脱且由此有利于导管插入血管。导入针头远端尖端延伸超过导管远端尖端,其中针头斜面背离患者的皮肤。
将导管或导入针头组件以表浅的角度通过患者皮肤插入血管。存在许多将这类导管和导入针头组件插入患者的技术。在一种插入技术中,将导入针头和导管共同完全插入血管。在另一种技术中,在最初插入血管后将导入针头部分抽入导管。然后使导管在针头上穿过并且完全插入血管。
PICC可以具有两个平行的隔室,其中每个具有其自身的外部连接器(双-腔),或单一管和连接器(单-腔)。从外部看,单-腔PICC类似于外周IV,但除外管适度增宽。
端口(通常称作其商品名,诸如Port-a-Cath或MediPort)为不具有外部连接器的中心静脉线路;而它具有植入皮下的小储器。通过将小针头放入皮下的储器内间歇给药。端口产生的不便利性较低并且具有的感染风险低于PICCs且由此常用于长期间歇疗法的患者。
在某些实施方案中,本发明的抗微生物组合物可以用作上述导管类型中的任意种中的导管锁定溶液,以便对具有插入或植入患者身体部分,诸如静脉的导管的患者提供抗微生物防护作用。可以将锁定溶液放入导管以便提供短或长期的防护作用,例如1小时-约1周,一般类似地约48小时-约1周。用包含至少一种醇,至少一种不为醇的杀生物剂和至少一种泊洛沙姆表面活性剂的组合物实现这一目的。在一种可选择的实施方案中,该组合物可以包含至少一种泊洛沙姆表面活性剂和至少一种醇。
在某些实施方案中,可以用本发明的抗微生物组合物涂敷导管内表面的至少部分(如果需要的话也可用于任意的外表面)。可以用本发明抗微生物组合物涂敷的导管内表面的非限制性实例包括腔,管,塞,帽等。可以通过本领域技术人员众所周知的任意方法,诸如浸渍,喷雾等涂布涂层。可以将该涂层作为如下所述的溶液涂布并且可以任选至少部分干燥。如果需要,涂层厚度一般可以在约1μm-约1mm。
在某些实施方案中,具有内涂层的导管可以具有放入导管内的锁定溶液。该锁定溶液可以为任意的锁定溶液或可以为如本文所述的本发明锁定溶液。
本发明的抗微生物组合物包含一种或多种醇类。合适的醇类包括,例如乙醇、异丙醇、丙二醇、苄醇、氯丁醇、苯乙醇等。在某些实施方案中,至少一种醇为C1-C6低级醇,诸如乙醇或异丙醇。在其它实施方案中,C1-C6低级醇为异丙醇和乙醇的混合物,其比例约为1:10-1:1。尽管不希望受到任何理论约束,但是认为醇(类)可以开放导管材料的孔结构以便有利于抗微生物组合物透过并且可以延长抗微生物组合物的释放率。一种或多种醇类的存在量至少占抗微生物组合物总重的10wt.%,优选50-95wt.%。
本发明的抗微生物组合物可以进一步包含至少一种或多种不为醇的杀生物剂(如上所述)。术语"杀生物剂(biocidal agent)"或"杀生物剂(biocide)"意指破坏、抑制和防止不需要的生物体增殖、生长和繁殖的活性剂。术语"生物体"包括,但不限于微生物、细菌、波形菌、螺旋菌、孢子、产芽胞生物体、革兰氏阴性生物体、革兰氏阳性生物体、酵母、真菌、霉菌、病毒、需氧生物体、厌氧生物体和分支杆菌。这类生物体的具体实例包括:真菌、黑色曲霉(Aspergillusniger)、黄色曲霉(Aspergillus flavus)、变黑色根霉(Rhizopusnigricans)、腊叶枝孢(Cladosporium herbarium)、絮状表皮癣菌(Epidermophyton floccosum)、须发癣菌(Trichophytonmentagrophytes)、夹膜组织胞浆菌(Histoplasma capsulatum)等;细菌,诸如铜绿假单胞菌(Pseudomonas aeruginosa)、大肠埃希氏杆菌(Escherichia coli)、普通变形菌(Proteus vulgaris)、金黄色葡萄球菌(Staphylococcus aureus)、表皮葡萄球菌(Staphylococcus epidermis)、粪链球菌(Streptococcusfaecalis)、克雷伯氏菌属(Klebsiella)、产气肠杆菌(Enterobacteraerogenes)、奇异变形菌(Proteus mirabilis)、其它革兰氏阴性菌和其它革兰氏阳性菌、分枝杆菌生长素等;和酵母,诸如啤酒糖酵母(Saccharomyces cerevisiae)、白色假丝酵母(Candida albicans)等。另外,微生物孢子、病毒等为本发明范围内的生物体。
适用于本发明的杀生物剂包括,但不限于如下杀生物剂,诸如苯酚、季铵杀生物剂、释放氯的杀生物剂、喹啉、喹醛啶(quinaldinium)、缩氨基硫脲、醌、磺胺、氨基甲酸酯类、水杨酰胺、碳酰苯胺、酰胺、guanide、脒、螯合物和咪唑啉杀生物剂。
可以用于本发明的其它合适的杀生物剂包括,例如乙酸、苯甲酸、山梨酸、丙酸、脱氢乙酸、亚硫酸、香草酸、对-羟基苯甲酸酯类、2-溴-2-硝基丙-1,3-二醇、甲醛、戊二醛、次氯酸钙、次氯酸钾、碘(在各种溶剂中)、聚维酮-碘、乌洛托品、诺昔硫脲、1-(3-氯烯丙基)-3,5,7-叠氮基1-氮鎓金刚烷氯化物、牛磺罗定、氧氢噻二嗪、EDTA、N(5-硝基-2-亚糠基)-1-氨基-乙内酰脲、5-硝基-2-糠醛缩氨基脲、3,4,4'-三氯碳酰苯胺、3,4',5-三溴水杨酰苯胺、水杨苯胺、3-三氟甲基-4,4'-二氯碳酰苯胺、8-羟基喹啉、1-环丙基-6-氟-1,4-二氢-4-氧代-7-(1-哌嗪基)-3-喹啉羧酸、1,4-二氢-1-乙基-6-氟-4-氧代-7-(1-哌嗪基)-3-喹啉羧酸、过氧化氢、过乙酸、奥昔氯生钠、对氯间二甲酚、2,4,4'-三氯-2'-羟基二苯酚、磺胺嘧啶银和硝酸银。
额外合适的杀生物基包括染料,诸如吖啶、吖啶黄素、盐酸氨吖啶、半硫酸二氨基吖啶、三苯甲烷、碱式品红、结晶紫、猩红、副玫瑰苯胺和玫瑰苯胺;释放氯的杀生物剂,诸如次氯酸钠、奥昔氯生、氯胺、二氯二甲基乙内酰脲、哈拉宗、二氯胺、chlorasine、琥珀酰氯亚胺、三氯异氰尿酸、二氯异氰尿酸盐、三氯蜜胺、二氯甘脲、卤化二烷基-乙内酰脲和halane;喹醛啶和喹啉杀生物剂,诸如地喹铵、劳利铵、羟基喹啉、lioquinol、氯喹那多、哈喹诺、氨喹脲、苯甲酰喹、溴羟喹啉、二氯羟喹、氯羟喹、乙氢去甲奎宁、尤普罗辛、北美黄连碱、8-羟基喹啉、8-羟基喹啉硫酸盐和氯碘羟喹;季铵杀生物剂、包括吡啶鎓杀生物剂、苯扎氯铵、十六烷基三甲基溴化铵、苄索氯铵、氯化西吡铵、安索氯芬铵、醋酸地喹铵、氯化地喹铵、溴化度米芬、醋酸劳利铵、氯化甲苄乙氧胺、肉豆蔻基-γ-皮考啉鎓氯化物、ortaphonium chloride和曲比氯铵;呋喃类,诸如灰黄霉素、硝基糠醛、硝基呋喃酮、硝基呋喃妥英、妥英、呋喃他酮、2-(甲氧基甲基)-5-硝基呋喃、尼屈昔腙、硝呋醛肟和硝呋肼;苯酚杀生物剂,诸如氯化苯酚、甲酚、麝香草酚、香荆芥酚(carvacol)、醋辛酚汞、芬替克洛、氯甲酚、氯二甲酚、六氯酚、双酚类、戊间甲酚、硫氯酚、氯麝酚、二氯二甲酚、苄氯酚(chlorophene)、对-氯苯酚、对-苯基苯酚、三硝基苯酚、二氯双酚、溴氯双酚、1-萘基水杨酸酯、2-萘基水杨酸酯、2,4,6-三溴-间-甲酚和3',4',5-三氯水杨酰苯胺;内酯类,诸如丙内酯;和脲类,诸如诺昔硫脲,polynoxylen和triclocarbon。
其它适用于本发明的杀生物剂包括氯己定、葡糖酸氯己定、醋酸氯己定、盐酸氯己定、二溴普罗帕脒、卤化二苯基烷类、二溴沙仑、美溴沙仑、三溴沙仑、碳酰苯胺、水杨苯胺、四氯水杨酰苯胺、三氯碳酰苯胺、羟乙基磺酸普罗帕脒、喷他脒、哌氯定、mendalamine、酸加成物和季铵、扁桃酸乌洛托品、聚甲醛酯类,诸如聚甲醛二酯、聚甲醛二乙酸酯等及其混合物。
可以用作本发明所用的杀生物剂的抗菌药包括胍类,诸如阿来西定和安巴腙;卤素和卤素化合物,诸如冰片氯、碘酸钙、氯氟苯脲、flurosalan、碘酸、次氯酸钠、碘酸钠、氯氧三嗪、麝酚碘、三氯卡班、三氯生和曲氯新钾;汞化合物,诸如萘磺汞、汞林钠、汞溴红、氨合物、苯磺酸汞钠(mercuric sodium henolsulfonate)、琥珀酰亚胺汞、硫化汞、红、羟汞硝酚钠、醋酸亚汞、氯化亚汞、碘化亚汞、硫柳汞酊、硫汞苯磺钠和硫柳汞;和其它,诸如醋酸铝溶液、次醋酸铝溶液、硫酸铝、3-氨基-4-羟基丁酸、硼酸、氯阿唑丁、乙酸间-甲酚酯、硫酸铜、鱼石脂、间甲酚磺酸-甲醛缩聚物、奥硝唑、β-丙内酯和α-萜品醇。
有用的杀生物剂还包括低聚甲醛聚合物。用作杀生物剂的低聚甲醛聚合物选自通式(CH2O)n的环状三聚体,其中n为3;和通式HO(CH2O)mH的线性聚合物,其中m为3-125。这些聚合物为白色结晶固体并且在水分存在下进行解聚而生成水溶性杀生物剂和消毒剂甲醛;参见Encyclopedia of Chemical Technology,Kirk-Othmer,Vol.10,81页,1966,John Wiley & Sons,Inc.,New York出版。在操作中,低聚甲醛被来自周围的流体水分活化,导致其解聚成甲醛。甲醛作为杀生物剂或消毒剂起作用以便控制存在的微生物。一般而言,在有水分或水分与酸催化剂存在下,环状和线性聚合物被转化成99%甲醛,它在延长时间期限内释放。
尤其优选的杀生物剂包括葡糖酸氯己定,醋酸氯己定(chlorhexidine acetate),醋酸氯己定(chlorhexidinediacetate),三氯生,氯二甲酚,地喹氯铵,苄索氯铵,苯扎氯铵及其组合。在某些实施方案中,一种或多种杀生物剂的存在量占所述抗微生物组合物总重的约0.01-10wt.%或约0.01-5wt.%。
除所述的醇和杀生物剂外,本发明的抗微生物组合物进一步包含一种或多种泊洛沙姆。泊洛沙姆为非离子型聚氧乙烯-聚氧丙烯嵌段共聚物。合适的泊洛沙姆可以包括,例如聚氧丙烯的疏水性节段和聚氧乙烯的亲水性节段,诸如具有如下化学式的那些:
HO(C2H4O)a(C3H6O)b(C2H4O)aH其中a至少为12且b为整数,使得(C2H4O)表示的亲水性部分构成完整共聚物重量的约50-90%。优选平均分子量约2,000-约18,000道尔顿。合适的泊洛沙姆的非限制性实例包括表1中所列的那些:
表1
泊洛沙姆(USP级) | a | b | 平均分子量(道尔顿) |
124 | 12 | 20 | 2090-2360 |
188 | 80 | 27 | 7680-9510 |
237 | 64 | 37 | 6840-8830 |
338 | 141 | 44 | 12700-17400 |
407 | 101 | 56 | 9840-14600 |
在USP命名法中,"泊洛沙姆"的非专有名称后面跟随数字,前2个数字在乘以100时相当于所述共聚物聚氧丙烯部分的近似平均分子量,而第3个数字在乘以10时相当于聚氧乙烯部分的重量百分比。
泊洛沙姆也称作其它名称,诸如甲基环氧乙烷聚合物,具有环氧乙烷的聚合物;聚乙二醇-聚丙二醇聚合物;和α-氢化-ω-羟基聚(氧乙烯)-聚(氧丙烯)聚(氧乙烯)嵌段共聚物。合适的泊洛沙姆的非限制性实例包括 NF级嵌段共聚物,诸如 L44NF泊洛沙姆124, F65NF泊洛沙姆188, F87NF泊洛沙姆237, F108NF泊洛沙姆338和 F127NF泊洛沙姆407,它们购自BASF Corporation of Mt.Olive,New Jersey。优选的泊洛沙姆为泊洛沙姆188,泊洛沙姆237和泊洛沙姆407。
一种或多种泊洛沙姆的存在量占所述抗微生物组合物总重的约0.01wt.%-5wt.%或约0.1wt.%-2wt.%。
尽管不希望受到任何理论约束,但是认为泊洛沙姆表面活性剂在锁定组合物中的应用可以与醇起协同作用以使组合物透入导管材料自身。此外,泊洛沙姆可以起结合导管表面的作用。在这种方式中,认为泊洛沙姆可以起延长组合物从导管表面释放率的作用,和/或起减缓透入导管材料的组合物的浸沥率的作用。以这种方式,当导管腔内的杀生物剂耗尽时,认为储存在导管材料中的杀生物剂浸出或缓慢从导管材料中释放,由此补充杀生物剂且由此提供持续和延长的抗微生物活性。
泊洛沙姆与血液相容并且为无毒性的。锁定溶液通常包含抗凝剂以便从导管中除去凝固的血液,从而防止阻塞。泊洛沙姆具有抗凝血活性,由此消除了对在组合物中具有该活性的额外化合物的需求。此外,泊洛沙姆可以清洁导管内部并且消除红细胞或可以导致感染的生物膜的累积。
所述的抗微生物组合物任选进一步包含添加剂。合适的添加剂包括,但不限于抗凝剂,盐水,水及其组合。当将盐用于制剂时,水作为盐的载体是必不可少的并且存在量可以占抗微生物组合物总重的约5wt.%-45wt.%。在添加其它组分后,水或盐水一般构成组合物的平衡物。
本文所用的术语"抗凝剂"意指具有直接或间接防止血液凝固或溶解血块或一旦形成的其它凝固种类的能力的任意化合物。这类化合物的实例包括,但不限于柠檬酸氢二铵,酒石酸二铵,柠檬酸,柠檬酸二钠盐,柠檬酸一钾盐,柠檬酸一钠盐,柠檬酸三钾盐,柠檬酸三钠盐,乙二胺四乙酸(EDTA),EDTA二铵盐,EDTA二钾盐,EDTA二钠盐,EDTA四钠盐,乙烯双(氧基乙基次氮基)四乙酸(EGTA),EDTA三钠盐,EDTA三钾盐,乙二醇-O,O'-双(2-氨基乙基)-N,N,N',N'-四乙酸,N-(2-羟乙基)乙二胺-N,N',N'-三乙酸三钠盐,次氮基三乙酸,酒石酸钾钠,D-酒石酸氢钾,L-酒石酸二钾盐,L-酒石酸二钠盐,L-酒石酸一钠盐,肝素,华法林,乙酰水杨酸,布洛芬,吲哚美辛,前列腺素,磺吡酮,链激酶,尿激酶,组织纤溶酶原激活物(TPA),香豆素,硫酸鱼精蛋白,抗凝血酶III,可密定,蛋白质C/蛋白质S,醋硝香豆素,苯丙香豆素,水蛭素,二价水蛭素等。可以使用上述混合物。优选的抗凝剂为EDTA。如果存在,那么所述的抗凝剂的使用量占抗微生物组合物总重的约0.01-3wt%,更优选约0.1-1wt.%。
可以通过在室温下简单混合制备本发明的组合物。一般而言,首先混合所用的醇和任意的水,随后按照任意顺序添加其它组分。
在某些实施方案中,本发明提供了用于对植入导管提供长期消毒的方法,包括将所述的抗微生物组合物或包含它们的抗微生物组合物导入导管腔,该抗微生物组合物包含至少一种低级醇,至少一种抗微生物剂和至少一种泊洛沙姆。在其它实施方案中,该组合物可以包含至少一种低级醇和至少一种泊洛沙姆。优选导管腔基本上被该抗微生物组合物填充。将该组合物在医疗应用间期,诸如,例如输血,输注药物,营养物等之间期中导入导管。本发明的抗微生物组合物可以提供约48小时-约1周期限的杀生物活性。
本发明在其它实施方案中提供了用于消毒导管的方法,包括用抗微生物组合物涂层涂敷导管的至少部分内表面和任选任意所需的外表面,所述的抗微生物组合物包含至少一种低级醇,至少一种抗微生物剂和至少一种泊洛沙姆或抗微生物组合物包含如上文详细描述的至少一种低级醇和至少一种泊洛沙姆。
一般而言,该组合物用于锁定由聚氨基甲酸酯或硅氧烷材料制成的导管,并且其它类型的由类似材料制成的导管以及医疗装置可以与该组合物联用。
实施例
指定下列实施例用于例证本发明,但不应将其视为以任何方式限定本发明。
使用下表2中所述的组分制备制剂1-14,其用量如表3中所示:
表2
组分 | 供应商 |
乙醇(90检验) | VWR International,Inc.West Chester,Pennsylvania |
异丙醇(IPA)(>99%醇) | JT BakerPhillipsburg,New Jer sey |
葡糖酸氯己定(20%) | Xttrium LaboratoriesChicago,Illinois |
盐水 | JT BakerPhillipsburg,New Jersey |
乙二胺-四乙酸粉末(EDTA) | The Dow Chemical CompanyMidland,Michigan |
USP水 | |
Pluronic F 68泊洛沙姆188 | BASFMt.Olive,New Jersey |
抑制区
测试浸渍制剂1-10的组合物中的管样品抑制各种微生物生长的能力。特别地提供了作为A和B管代表的两组管。
A管为购自Cleveland,Ohio的Noveon,Inc.的Tecoflex聚氨基甲酸酯管并且为一般用于中心静脉导管的一类管。B管为购自Franklin Lakes,New Jersey的Becton Dickinson的一般用于外周导管的聚氨基甲酸酯管。在测试前不预先清洁管样品。对每种样品而言,将约5mm管材料浸渍各个制剂1-10(在室温)的抗微生物组合物并且在烘箱内干燥。还测试了未浸渍任何制剂的对照管样品。然后将管放在包被了胰蛋白酶解酪蛋白大豆肉汤生长培养基的琼脂平板上,所述的培养基中接种了铜绿假单胞菌,白色假丝酵母,大肠埃希氏杆菌或金黄色葡萄球菌的常见微生物。将1ml108-109测试生物铺展在每个琼脂平板上并且在30°-35℃下孵育。在24小时,48小时和72小时时检验平板并且通过视力检查测定微生物生长被抑制区域的半径(mm)。结果如表4-7中所示。
表4
用铜绿假单胞菌攻击的管样品的以毫米计的抑制区域
A管 | B管 | |
对照品 | 0 | 0 |
制剂1 | 0 | 0 |
制剂2 | 0 | 0 |
制剂3 | 0 | 0 |
制剂4 | 0 | 0 |
制剂5 | 0 | 0 |
制剂6 | 0 | 1 |
制剂7 | 3 | 3 |
制剂8 | 0 | 0 |
制剂9 | 0 | 0 |
制剂10 | 0 | 0 |
表5
用白色假丝酵母攻击的管样品的以毫米计的抑制区域
A管 | B管 | |
对照品 | 0 | 0 |
制剂1 | 0 | 0 |
制剂2 | 0 | 1 |
制剂3 | 0 | 0 |
制剂4 | 2 | 3 |
制剂5 | 1 | 0 |
制剂6 | 1 | 0 |
制剂7 | 3 | 3 |
制剂8 | 0 | 1 |
制剂9 | 0 | 0 |
制剂10 | 0 | 0 |
表6
用大肠杆菌攻击的管样品的以毫米计的抑制区域
A管 | B管 | |
对照品 | 0 | 0 |
制剂1 | 2 | 1 |
制剂2 | 0 | 1 |
制剂3 | 0 | 1 |
制剂4 | 2 | 2 |
制剂5 | 1 | 1 |
制剂6 | 1 | 1 |
制剂7 | 2 | 4 |
制剂8 | 2 | 1 |
制剂9 | 0 | 0 |
制剂10 | 1 | 1 |
表7
用金黄色葡萄球菌攻击的管样品的以毫米计的抑制区域
A管 | B管 | |
对照品 | 0 | 0 |
制剂1 | 3 | 2 |
制剂2 | 3 | 3 |
制剂3 | 1 | 1 |
制剂4 | 4 | 3 |
制剂5 | 2 | 1 |
制剂6 | 2 | 2 |
制剂7 | 5 | 5 |
制剂8 | 3 | 2 |
制剂9 | 0 | 0 |
制剂10 | 2 | 2 |
例如,正如表4中所示,就A和B管样品而言,浸渍本发明制剂7的管防止了管周围3mm区内的铜绿假单胞菌微生物生长。具有较低量葡糖酸氯己定的制剂8-10抑制了生长,但不与制剂7一样进行。通过所有测试生物体(表4-7),具有最高量葡糖酸氯己定的制剂(制剂7)在抑制测试微生物生长方面进行得最佳。尽管不指定受任何理论约束,但是认为泊洛沙姆可以结合导管材料并且延长抗微生物组合物的释放率。
杀菌有效性试验
评价制剂1-10对靶微生物,即金黄色葡萄球菌,铜绿假单胞菌,白色假丝酵母和大肠杆菌(E.Coli)的杀生物有效性。它们为代表革兰氏阳性菌,革兰氏阴性菌和真菌类型的标准微生物。如下进行杀生物有效性测试:
将5毫升每种制剂加入到无菌管中。向5ml测试溶液中加入含具有适当计数的靶微生物的0.1ml微生物攻击物(1ml含约108-109个微生物)。在1分钟和5分钟接触时间时,将1.0ml样品转入9.0mlDifco Dey Engley中和肉汤。随后将1.0ml样品转入Difco Dey Engley中和肉汤基质。将所有样品在30-33℃下孵育48小时。
所述制剂的有效测试结果如表8中所示。在接触这些溶液1分钟后杀灭了所有测试细菌。
表8
杀菌功效测试
(所有10种制剂在全浓度下的结果)
制剂序号 | 时间增量 | 大肠杆菌 | 铜绿假单胞菌 | 金黄色葡萄球菌 | 白色假丝酵母 |
1 | 1分钟 | - | - | - | - |
1 | 5分钟 | - | - | - | - |
2 | 1分钟 | - | - | - | - |
2 | 5分钟 | - | - | - | - |
3 | 1分钟 | - | - | - | - |
3 | 5分钟 | - | - | - | - |
4 | 1分钟 | - | - | - | - |
4 | 5分钟 | - | - | - | - |
5 | 1分钟 | - | - | - | - |
5 | 5分钟 | - | - | - | - |
6 | 1分钟 | - | - | - | - |
6 | 5分钟 | - | - | - | - |
7 | 1分钟 | - | - | - | - |
7 | 5分钟 | - | - | - | - |
8 | 1分钟 | - | - | - | - |
8 | 5分钟 | - | - | - | - |
9 | 1分钟 | - | - | - | - |
9 | 5分钟 | - | - | - | - |
10 | 1分钟 | - | - | - | - |
10 | 5分钟 | - | - | - | - |
(-)=无生长
(+)=生长
无生长表示有效抗微生物活性
生长表示缺乏有效的抗微生物活性
尽管上文为例证目的描述了本发明的具体实施方案,但是本领域技术人员显而易见可以在不脱离如待批权利要求定义的本发明的情况下对本发明的详细内容进行大量变型。
Claims (46)
1.抗微生物组合物,包含:
至少一种泊洛沙姆;
占该抗微生物组合物总重至少10重量百分比的至少一种醇;和
至少一种不为醇的杀生物剂。
2.权利要求1所述的抗微生物组合物,其中所述的泊洛沙姆由下式表示:
HO(C2H4O)a(C3H6O)b(C2H4O)aOH
其中a至少为12且b为整数,使得(C2H4O)表示的亲水部分构成整个聚合物重量的约50-约90%。
3.权利要求2所述的抗微生物组合物,其中所述泊洛沙姆的平均分子量约为2,000-约18,000道尔顿。
4.权利要求3所述的抗微生物组合物,其中至少一种泊洛沙姆选自泊洛沙姆188,泊洛沙姆237和泊洛沙姆407。
5.权利要求1所述的抗微生物组合物,其中所述的泊洛沙姆的存在量占该抗微生物组合物重量的约0.01wt.%-约5wt.%。
6.权利要求1所述的抗微生物组合物,其中所述的杀生物剂选自β-丙内酯、α-萜品醇、1-(3-氯烯丙基)-3,5,7-叠氮基-1-氮鎓金刚烷氯化物、1,4-二氢-1-乙基-6-氟-4-氧代-7-(1-哌嗪基)-3-喹啉羧酸、1-环丙基-6-氟-1,4-二氢-4-氧代-7-(1-哌嗪基)-3-喹啉羧酸、1-萘基水杨酸酯、2-(甲氧基甲基)-5-硝基呋喃、2,4,4′-三氯-2′-羟基二苯酚、2,4,6-三溴-间-甲酚、2-溴-2-硝基丙-1,3-二醇、2-萘基水杨酸酯、3,4,4′-三氯碳酰苯胺、3,4′,5-三溴水杨酰苯胺、3′,4′,5-三氯水杨酰苯胺、3-氨基-4-羟基丁酸、3-三氟甲基-4,4′-二氯碳酰苯胺、5-硝基-2-糠醛缩氨基脲、8-羟基喹啉硫酸盐、8-羟基喹啉、乙酸、醋辛酚汞、吖啶、吖啶黄素、阿来西定、醋酸铝溶液、次醋酸铝溶液、硫酸铝、安巴腙、酰胺、脒、盐酸氨吖啶、氨喹脲、氨合物、对苯酚磺酸钠汞、戊间甲酚、苯扎氯铵、苄索氯铵、苯甲酸、苯甲酰喹、双酚类、硫氯酚、硼酸、冰片基氯、溴氯双酚、溴羟喹啉、次氯酸钙、碘酸钙、氨基甲酸酯类、碳酰苯胺、碳酰苯胺、香荆芥酚、十六烷基三甲基溴化铵、氯化西吡铵、螯合物和咪唑啉杀生物剂、氯胺、chlorasine、醋酸氯己定、葡糖酸氯己定、盐酸氯己定、氯己定、氯化苯酚、释放氯的杀生物剂、氯阿唑丁、氯甲酚、苄氯酚、氯麝酚、二氯羟喹、氯二甲酚、安索氯芬铵、氯喹那多、氯氟苯脲、氯羟喹、甲酚、结晶紫、硫酸酮、脱氢乙酸、醋酸地喹铵、氯化地喹铵、地喹铵、双溴丙脒、二溴沙仑、二氯胺、二氯双酚、二氯二甲基乙内酰脲、二氯甘脲、二氯异氰尿酸、二氯二甲酚、度米芬、EDTA、对-羟基苯甲酸酯类、乙氢去甲奎宁、尤普罗辛、芬替克洛、flurosalan、甲醛、呋喃他酮、呋喃唑酮、戊二醛、灰黄霉素、guanide、halane、哈拉宗、卤化二烷基-乙内酰脲、卤化二苯基烷类、哈喹诺、六氯酚、乌洛托品、萘磺汞、北美黄连碱、过氧化氢、羟基喹啉、鱼石脂、碘酸、碘、氯碘羟喹、内酯、醋酸劳利铵、劳利铵、lioquinol、碱式品红、醋酸间甲酚酯、mendalamine、汞林钠、汞溴红、琥珀酰亚胺汞、硫化汞、羟汞硝酚钠、醋酸亚汞、氯化亚汞、碘化亚汞、美溴沙仑、孟德立胺、甲苄索氯铵、肉豆蔻基-γ-皮考啉鎓氯化物、N(5-硝基-2-亚糠基)-1-氨基-乙内酰脲、间甲酚磺酸-甲醛缩聚物、尼屈昔腙、硝呋醛肟、硝呋肼、硝基呋喃妥英、呋喃西林、硝基糠醛、硝甲酚汞、诺昔硫脲、诺昔硫脲、奥硝唑、ortaphonium chloride、奥昔氯生、对氯间二甲酚、低聚甲醛聚合物、副玫瑰苯胺、对-氯酚、喷他脒、过乙酸、苯酚、哌氯定、polynoxylen、聚甲醛二乙酸酯、聚甲醛二酯、次氯酸钾、聚维酮碘、对-苯基苯酚、半硫酸二氨基吖啶、羟乙磺酸丙氧苯脒、丙内酯、丙酸、吡啶鎓杀生物剂、季铵杀生物剂、喹醛啶、喹啉、苯醌、红、玫瑰苯胺、水杨酰胺、水杨苯胺、猩红、硝酸银、磺胺嘧啶银、次氯酸钠、碘酸钠、氧氯苯磺酸钠、山梨酸、琥珀酰氯亚胺、磺胺、亚硫酸、氯氧三嗪、氯氧三嗪、牛磺罗定、氧氢噻二嗪、四氯水杨酰苯胺、硫汞苯磺钠、硫柳汞、缩氨基硫脲、麝酚碘、麝香草酚、三溴沙仑、三氯碳酰苯胺、三氯异氰尿酸、三氯蜜胺、曲比氯铵、三氯卡班、triclocarbon、三氯生和曲氯新钾、三硝基苯酚、三苯甲烷和香草酸。
7.权利要求1所述的抗微生物组合物,其中至少一种杀生物剂选自苯扎氯铵、苄索氯铵、醋酸氯己定、葡糖酸氯己定、氯二甲酚、地喹氯铵、三氯生及其组合。
8.权利要求7所述的抗微生物组合物,其中至少一种杀生物剂为葡糖酸氯己定。
9.权利要求1所述的抗微生物组合物,其中至少一种杀生物剂的存在量占该抗微生物组合物重量的约0.01wt.%-约10wt.%。
10.权利要求1所述的抗微生物组合物,其中所述的醇为C1-C6低级醇。
11.权利要求10所述的抗微生物组合物,其中C1-C6低级醇为异丙醇和乙醇的混合物。
12.权利要求11所述的抗微生物组合物,其中至少一种低级醇为异丙醇和乙醇的混合物并且存在量占该抗微生物组合物重量的约50-约95%。
13.权利要求1所述的抗微生物组合物,进一步包含选自抗凝剂,盐水,水及其组合的添加剂。
14.权利要求13所述的抗微生物组合物,其中所述的抗凝剂选自乙酰水杨酸、抗凝血酶III、柠檬酸二钠盐、柠檬酸一钾盐、柠檬酸一钠盐、柠檬酸三钾盐、柠檬酸三钠盐、柠檬酸、可密定、香豆素、柠檬酸氢二铵、酒石酸二铵、EDTA二铵盐、EDTA二钾盐、EDTA二钠盐、EDTA四钠盐、EDTA三钾盐、EDTA三钠盐、乙二醇-O,O′-双(2-氨基乙基)-N,N,N′,N′-四乙酸、乙烯双(氧基乙基次氮基)四乙酸、乙二胺四乙酸(EDTA)、肝素、水蛭素、二价水蛭素,布洛芬、吲哚美辛、L-酒石酸二钾盐、L-酒石酸二钠盐、L-酒石酸一钠盐、N-(2-羟乙基)乙二胺-N,N′,N′-三乙酸三钠盐、醋硝香豆素、次氮基三乙酸、苯丙香豆素、D-酒石酸氢钾、酒石酸钾钠、前列腺素、硫酸鱼精蛋白、蛋白质C/蛋白质S、链激酶、磺吡酮、组织纤溶酶原激活物(TPA)、尿激酶和华法林。
15.权利要求13所述的抗微生物组合物,其中所述的抗凝剂为乙二胺四乙酸。
16.包含权利要求1所述的抗微生物组合物的导管。
17.具有涂敷了权利要求1所述的抗微生物组合物的至少一种内表面的导管。
18.包含抗微生物组合物的导管涂层,所述的抗微生物组合物包含:
至少一种泊洛沙姆;
占所述抗微生物组合物总重至少10重量百分比的至少一种醇;和
至少一种不为醇的杀生物剂。
19.提供用于植入导管消毒的方法,包括将抗微生物组合物导入导管腔,该抗微生物组合物包含至少一种不为醇的杀生物剂,占抗微生物组合物总重的至少10重量百分比的至少一种醇和至少一种泊洛沙姆。
20.权利要求19所述的方法,其中所述至少一种杀生物剂的存在量占所述抗微生物组合物总重的约0.01wt.%-约10wt.%,且至少一种泊洛沙姆的存在量占所述抗微生物组合物总重的约0.01wt.%-5wt.%。
21.权利要求19所述的方法,其中所述的醇为C1-C6低级醇。
22.权利要求21所述的方法,其中C1-C6低级醇为异丙醇和乙醇的混合物。
23.权利要求21所述的方法,其中所述的至少一种低级醇为异丙醇和乙醇的组合,其达到总计占所述抗微生物组合物重量的50-95wt%。
24.权利要求19所述的方法,其中将所述的抗微生物组合物维持在导管腔内约48小时-约1周的时间期限。
25.提供用于植入导管消毒的方法,包括用抗微生物组合物涂敷导管的至少部分内表面,该抗微生物组合物包含至少一种不为醇的杀生物剂,占抗微生物组合物总重的至少10重量百分比的至少一种醇和至少一种泊洛沙姆。
26.抗微生物组合物,包含:
至少一种泊洛沙姆;和
占该抗微生物组合物总重至少10%重量的至少一种醇。
27.权利要求26所述的抗微生物组合物,其中泊洛沙姆由下式表示:
HO(C2H4O)a(C3H6O)b(C2H4O)aOH
其中a至少为12且b为整数,使得(C2H4O)表示的亲水性部分占整个聚合物重量的约50-约90%。
28.权利要求26所述的抗微生物组合物,其中泊洛沙姆的平均分子量约为2,000-约18,000道尔顿。
29.权利要求26所述的抗微生物组合物,其中至少一种泊洛沙姆选自泊洛沙姆188,泊洛沙姆237和泊洛沙姆407。
30.权利要求26所述的抗微生物组合物,其中泊洛沙姆的存在量占该抗微生物组合物重量的约0.01wt.%-约5wt.%。
31.权利要求26所述的抗微生物组合物,其中所述的醇为C1-C6低级醇。
32.权利要求31所述的抗微生物组合物,其中C1-C6低级醇为异丙醇和乙醇的混合物。
33.权利要求26所述的抗微生物组合物,其中至少一种低级醇为异丙醇和乙醇的混合物并且其存在量占该抗微生物组合物重量的约50-约95%。
34.权利要求26所述的抗微生物组合物,进一步包括选自抗凝剂,盐水,水及其组合的添加剂。
35.权利要求34所述的抗微生物组合物,其中所述的抗凝剂选自乙酰水杨酸、抗凝血酶III、柠檬酸二钠盐、柠檬酸一钾盐、柠檬酸一钠盐、柠檬酸三钾盐、柠檬酸三钠盐、柠檬酸、可密定、香豆素、柠檬酸氢二铵、酒石酸二铵、EDTA二铵盐、EDTA二钾盐、EDTA二钠盐、EDTA四钠盐、EDTA三钾盐、EDTA三钠盐、乙二醇-O,O′-双(2-氨基乙基)-N,N,N′,N′-四乙酸、乙烯双(氧基乙基次氮基)四乙酸(EGTA)、乙二胺四乙酸(EDTA)、肝素、水蛭素、二价水蛭素,布洛芬、吲哚美辛、L-酒石酸二钾盐、L-酒石酸二钠盐、L-酒石酸一钠盐、N-(2-羟乙基)乙二胺-N,N′,N′-三乙酸三钠盐、醋硝香豆素、次氮基三乙酸、苯丙香豆素、D-酒石酸氢钾、酒石酸钾钠、前列腺素、硫酸鱼精蛋白、蛋白质C/蛋白质S、链激酶、磺吡酮、组织纤溶酶原激活物(TPA)、尿激酶和华法林。
36.权利要求34所述的抗微生物组合物,其中所述的抗凝剂为乙二胺四乙酸。
37.导管,包含权利要求26所述的抗微生物组合物。
38.导管,具有至少一种涂敷了权利要求26所述的抗微生物组合物的内表面。
39.包含抗微生物组合物的导管涂层,所述的抗微生物组合物包含:
至少一种泊洛沙姆;和
占所述抗微生物组合物总重至少10%重量的至少一种醇。
40.提供用于植入导管长期消毒的方法,包括将抗微生物组合物导入导管腔,该抗微生物组合物包含占该抗微生物组合物总重至少10%重量的至少一种醇和至少一种泊洛沙姆。
41.权利要求40所述的方法,其中所述的至少一种泊洛沙姆的存在量占所述抗微生物组合物总重的约0.01wt.%-5wt.%。
42.权利要求40所述的方法,其中所述的醇为C1-C6低级醇。
43.权利要求42所述的方法,其中C1-C6低级醇为异丙醇和乙醇的混合物。
44.权利要求43所述的方法,其中所述的至少一种低级醇为异丙醇和乙醇的组合物,总计达到占所述抗微生物组合物重量的50-95wt%。
45.权利要求40所述的方法,其中将所述的抗微生物组合物维持在导管腔内约48小时-约1周的时间期限。
46.提供用于植入导管消毒的方法,包括用抗微生物组合物涂敷导管的至少部分内表面,该抗微生物组合物包含占该抗微生物组合物总重至少10%重量的至少一种醇和至少一种泊洛沙姆。
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CA (2) | CA2858956C (zh) |
ES (2) | ES2862464T3 (zh) |
IL (1) | IL193746A (zh) |
MX (1) | MX2008011085A (zh) |
NO (1) | NO344659B1 (zh) |
WO (1) | WO2007100776A2 (zh) |
ZA (1) | ZA200807487B (zh) |
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