I. Isendlalelo
Ngokuvamile, izinsiza zezokwelapha ezifakwe inzalo nge-ethylene oxide kufanele zihlaziywe futhi zihlolwe ukuze kutholwe izinsalela zangemva kokuhlinzwa, njengoba inani lensalela lihlobene eduze nempilo yalabo abavezwe ocingweni lwezokwelapha.I-Ethylene oxide iyisimiso sezinzwa esimaphakathi esicindezelayo.Uma kuxhunyanwa nesikhumba, ububomvu nokuvuvukala kwenzeka ngokushesha, ukuqhuma kwenzeka ngemva kwamahora ambalwa, futhi ukuthintana okuphindaphindiwe kungabangela ukuzwela.Ukuchaphaza uketshezi emehlweni kungabangela ukusha kwamakhone.Uma kwenzeka ukuchayeka isikhathi eside ngamanani amancane, i-neurasthenia syndrome kanye nokuphazamiseka kwemizwa ye-vegetative nerve kungabonakala.Kuye kwabikwa ukuthi i-acute oral LD50 kumagundane yi-330 mg/Kg, nokuthi i-ethylene oxide ingakhuphula izinga lokuphambuka kwe-chromosome yomnkantsha wethambo kumagundane [1].Amazinga aphezulu e-carcinogenicity nokufa kuye kwabikwa kubasebenzi abachayeke ku-ethylene oxide.[2] I-2-Chloroethanol ingabangela i-erythema yesikhumba uma ithinta isikhumba;ingamuncwa nge-percutaneously ukuze ibangele ubuthi.Ukungenwa ngomlomo kungaba yingozi.Ukuchayeka isikhathi eside okungamahlalakhona kungabangela ukulimala ohlelweni lwezinzwa olumaphakathi, uhlelo lwenhliziyo nemithambo yegazi namaphaphu.Imiphumela yocwaningo lwasekhaya neyangaphandle ku-ethylene glycol iyavuma ukuthi ubuthi bayo buphansi.Inqubo yemetabolism yayo emzimbeni iyafana neye-ethanol, ngokusebenzisa i-ethanol dehydrogenase ne-acetaldehyde dehydrogenase, imikhiqizo eyinhloko i-glyoxalic acid, i-oxalic acid ne-lactic acid, enobuthi obuphezulu.Ngakho-ke, izindinganiso eziningi zinezidingo eziqondile zezinsalela ngemva kokuvala inzalo nge-ethylene oxide.Ngokwesibonelo, GB/T 16886.7-2015 “Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residues”, YY0290.8-2008 “Ophthalmic Optics Artificial Lens Ingxenye 8: Basic Requirements”, kanye nezinye izilinganiso zinemininingwane yezidingo wezinsalela ze-ethylene oxide kanye ne-2-chloroethanol.GB/T 16886.7-2015 isho ngokucacile ukuthi uma usebenzisa i-GB/T 16886.7-2015, kushiwo ngokucacile ukuthi uma i-2-chloroethanol ikhona kumadivayisi wezokwelapha afakwe inzalo nge-ethylene oxide, i-residue yayo ephezulu evumelekile. futhi kunqunyelwe ngokucacile.Ngakho-ke, kuyadingeka ukuhlaziya ngokugcwele ukukhiqizwa kwezinsalela ezivamile (i-ethylene oxide, i-2-chlorethanol, i-ethylene glycol) kusukela ekukhiqizeni, ekuthuthweni nasekugcinweni kwe-ethylene oxide, ukukhiqizwa kwemishini yezokwelapha, kanye nenqubo yokuvala inzalo.
II.Ukuhlaziywa kwezinsalela zokuvala inzalo
Inqubo yokukhiqiza ye-ethylene oxide ihlukaniswe ngendlela ye-chlorohydrin kanye nendlela ye-oxidation.Phakathi kwazo, indlela ye-chlorohydrin iyindlela yokuqala yokukhiqiza i-ethylene oxide.Iqukethe ikakhulukazi izinqubo ezimbili zokusabela: isinyathelo sokuqala: C2H4 + HClO – CH2Cl – CH2OH;isinyathelo sesibili: CH2Cl – CH2OH + CaOH2 – C2H4O + CaCl2 + H2O.inqubo yayo yokusabela Umkhiqizo ophakathi yi-2-chloroethanol (CH2Cl-CH2OH).Ngenxa yobuchwepheshe obusemuva bendlela ye-chlorohydrin, ukungcoliswa okukhulu kwemvelo, okuhambisana nomkhiqizo wokugqwala okukhulu kwemishini, iningi labakhiqizi lisusiwe [4].Indlela ye-oxidation [3] ihlukaniswe yaba izindlela zomoya nomoya-mpilo.Ngokusho kokuhlanzeka okuhlukile kwe-oksijeni, ukukhiqizwa kokuyinhloko kuqukethe izinqubo ezimbili zokusabela: isinyathelo sokuqala: 2C2H4 + O2 - 2C2H4O;isinyathelo sesibili: C2H4 + 3O2 – 2CO2 + H2O.okwamanje, ukukhiqizwa kwezimboni ze-ethylene oxide Njengamanje, ukukhiqizwa kwezimboni ze-ethylene oxide ikakhulukazi kwamukela inqubo ye-ethylene eqondile ye-oxidation ngesiliva njenge-catalyst.Ngakho-ke, inqubo yokukhiqiza i-ethylene oxide iyisici esinquma ukuhlolwa kwe-2-chloroethanol ngemva kokuvalwa inzalo.
Ebhekisela ezinhlinzekweni ezifanele kuzinga le-GB/T 16886.7-2015 ukwenza ukuqinisekiswa nokuthuthukiswa kwenqubo yokuvala inzalo ye-ethylene oxide, ngokwezakhiwo ze-physicochemical ze-ethylene oxide, izinsalela eziningi zikhona ngendlela yokuqala ngemva kokuvalwa inzalo.Izinto ezithinta inani lensalela ngokuyinhloko zihlanganisa ukufakwa kwe-ethylene oxide ngamathuluzi ezokwelapha, izinto zokupakisha nokujiya, izinga lokushisa kanye nomswakama ngaphambi nangemva kokuvalwa inzalo, isikhathi sesenzo sokuvala inzalo nesikhathi sokuxazulula, izimo zokugcina, njll., futhi izici ezingenhla zinquma ukuphunyuka. ikhono le-ethylene oxide.Kuye kwabikwa ezincwadini [5] ukuthi ukuhlushwa kwe-ethylene oxide inzalo kuvame ukukhethwa njenge-300-1000mg.L-1.Izici zokulahlekelwa kwe-ethylene oxide ngesikhathi sokuvala inzalo ikakhulukazi zifaka: ukukhangisa kwemishini yezokwelapha, i-hydrolysis ngaphansi kwezimo ezithile zomswakama, njalonjalo.I-concentration ye-500-600mg.L-1 iyonga ngokuqhathaniswa futhi iyasebenza, inciphisa ukusetshenziswa kwe-ethylene oxide kanye nensalela ezintweni ezibulala inzalo, konga izindleko zokuvala inzalo.
I-Chlorine inezinhlobonhlobo zezicelo embonini yamakhemikhali, imikhiqizo eminingi ihlobene kakhulu nathi.Ingasetshenziswa njenge-intermediate, njenge-vinyl chloride, noma njengomkhiqizo wokugcina, njenge-bleach.Ngesikhathi esifanayo, i-chlorine nayo ikhona emoyeni, emanzini nakwezinye izindawo, ukulimala emzimbeni womuntu nakho kuyabonakala.Ngakho-ke, lapho amadivaysi ezokwelapha afanelekile enziwa inzalo nge-ethylene oxide, ukuhlaziya okuphelele kokukhiqizwa, ukuvala inzalo, ukugcinwa kanye nezinye izici zomkhiqizo kufanele kucatshangelwe, futhi izinyathelo ezihlosiwe kufanele zithathwe ukulawula inani elisele le-2-chloroethanol.
Kubikwe ezincwadini ukuthi okuqukethwe kwe-2-chloroethanol kufinyelele cishe ku-150 µg/ucezu ngemva kwamahora angu-72 okulungiswa kwe-band-aid patch efakwe i-ethylene oxide, futhi ngokubhekisela kumadivayisi okuxhumana esikhashana abekiwe. ezingeni le-GB/T16886.7-2015, isilinganiso somthamo wansuku zonke we-2-chloroethanol esigulini akufanele sibe ngaphezu kuka-9 mg, futhi inani layo eliyinsalela liphansi kakhulu kunenani elilinganiselwe elisezingeni.
Ucwaningo [7] lwakala izinsalela ze-ethylene oxide kanye ne-2-chloroethanol ezinhlotsheni ezintathu zezintambo ze-suture, futhi imiphumela ye-ethylene oxide yayingabonakali futhi i-2-chloroethanol yaba ngu-53.7 µg.g-1 kuntambo ye-suture enentambo yenayiloni. .I-YY 0167-2005 ibeka umkhawulo wokutholwa kwe-ethylene oxide kuma-sutures okuhlinzwa angamunceki, futhi akukho simiso se-2-chloroethanol.Ama-Sutures anamandla amaningi wamanzi ezimboni ohlelweni lokukhiqiza.Izigaba ezine zekhwalithi yamanzi wamanzi ethu angaphansi zisebenza endaweni evamile yokuvikelwa kwezimboni kanye nomzimba womuntu ukuthintana ngokuqondile nendawo yamanzi, ngokuvamile ephathwa nge-bleach, ingalawula ulwelwe kanye nama-microorganisms emanzini, asetshenziselwa inzalo kanye nokuvimbela ubhubhane lwenhlanzeko. .Isithako sayo esiyinhloko esisebenzayo yi-calcium hypochlorite, ekhiqizwa ngokudlula igesi ye-chlorine nge-limestone.I-calcium hypochlorite yonakala kalula emoyeni, ifomula yokusabela eyinhloko ithi: Ca(ClO)2+CO2+H2O–CaCO3+2HClO.i-hypochlorite ibola kalula ibe i-hydrochloric acid namanzi ngaphansi kokukhanya, indlela yokusabela eyinhloko ithi: 2HClO+light—2HCl+O2.2HCl+O2.Ama-ion e-Chlorine negative adsorbed kalula kuma-sutures, futhi ngaphansi kwezindawo ezithile ezine-acidic ebuthakathaka noma ezine-alkaline, i-ethylene oxide ivula iringi ngayo ukuze ikhiqize i-2-chloroethanol.
Kubikwe ezincwadini [8] ukuthi i-2-chloroethanol esele kumasampula e-IOL yakhishwa ngokukhipha i-ultrasonic nge-acetone futhi yanqunywa i-gas chromatography-mass spectrometry, kodwa ayizange ibonakale.YY0290.8-2008 “Ophthalmic Optics Artificial Ilensi Ingxenye 8: Izidingo Eziyisisekelo” ithi inani eliyinsalela le-2-chloroethanol ku-IOL akumele libe ngaphezu kuka-2.0µg ngosuku ilensi ngayinye, nokuthi inani eliphelele lelensi ngayinye akufanele libe ngaphezu kuka-5.0 The GB/T16886. I-7-2015 ejwayelekile isho ukuthi ubuthi be-ocular obubangelwa izinsalela ze-2-chloroethanol buphakeme izikhathi ezi-4 kunalokho okubangelwa izinga elifanayo le-ethylene oxide.
Kafushane, lapho kuhlolwa izinsalela zemishini yezokwelapha ngemva kokuvalwa inzalo nge-ethylene oxide, i-ethylene oxide ne-2-chloroethanol kufanele kugxilwe kuyo, kodwa izinsalela zazo kufanele futhi zihlaziywe ngokuphelele ngokuvumelana nesimo sangempela.
Ngesikhathi kufakwa inzalo kumishini yezokwelapha, ezinye zezinto ezingavuthiwe zemishini yezokwelapha esetshenziswa kanye noma izinto zokupakisha zifaka i-polyvinyl chloride (PVC), kanye nenani elincane kakhulu le-vinyl chloride monomer (VCM) nalo lizokhiqizwa ngokubola kwe-PVC resin. phakathi nokucubungula.Amapayipi e-PVC ezokwelapha athambile e-GB10010-2009 abeka ukuthi okuqukethwe kwe-VCM akukwazi ukudlula u-1µg.g-1.I-VCM yenziwa i-polymerized kalula ngaphansi kwesenzo se-catalysts (peroxides, njll) noma ukukhanya nokushisa ukuze kukhiqizwe i-polyvinyl chloride resin, ngokuhlanganyela eyaziwa ngokuthi i-vinyl chloride resin.I-vinyl chloride yenziwa i-polymerized kalula ngaphansi kwesenzo se-catalyst (i-peroxide, njll.) noma ukukhanya nokushisa ukukhiqiza i-polyvinyl chloride, ngokuhlanganyela eyaziwa ngokuthi i-vinyl chloride resin.Uma i-polyvinyl chloride ishisisa ngaphezu kuka-100°C noma ichayeke emisebeni ye-ultraviolet, kunethuba lokuthi igesi ye-hydrogen chloride ingase iphume.Khona-ke inhlanganisela yegesi ye-hydrogen chloride ne-ethylene oxide ngaphakathi kwephakheji izokhiqiza inani elithile le-2-chloroethanol.
I-Ethylene glycol, ezinzile ngokwemvelo, ayiguquguquki.I-athomu yomoya-mpilo ku-ethylene oxide ithwala amapheya amabili awodwa ama-electron futhi ine-hydrophilicity eqinile, okwenza kube lula ukukhiqiza i-ethylene glycol uma kuhlangene nama-ion e-chloride e-negative.Isibonelo: C2H4O + NaCl + H2O – CH2Cl – CH2OH + NaOH.le nqubo iyisisekelo esibuthakathaka ekugcineni esisebenzayo futhi iyisisekelo kakhulu ekugcineni kokuzala, futhi isigameko salokhu kusabela siphansi.Isigameko esiphezulu ukwakheka kwe-ethylene glycol kusuka ku-ethylene oxide lapho kuthintana namanzi: C2H4O + H2O - CH2OH - CH2OH, futhi ukugeleza kwe-ethylene oxide kuvimbela ukubopha kwayo kuma-ion angenayo i-chlorine mahhala.
Uma i-chlorine negative ion yethulwa ekukhiqizweni, inzalo, ukugcinwa, ukuthuthwa kanye nokusetshenziswa kwemishini yezokwelapha, kungenzeka ukuthi i-ethylene oxide izosabela ngayo ukuze yakhe i-2-chloroethanol.Njengoba indlela ye-chlorohydrin isusiwe enqubweni yokukhiqiza, umkhiqizo wayo ophakathi, i-2-chloroethanol, ngeke yenzeke ngendlela ye-oxidation eqondile.Ekukhiqizweni kwemishini yezokwelapha, izinto ezithile ezingavuthiwe zinezakhiwo eziqinile zokukhangisa ze-ethylene oxide ne-2-chloroethanol, ngakho ukulawulwa kwamanani azo asele kufanele kubhekwe lapho kuzihlaziya ngemva kokuvalwa inzalo.Ngaphezu kwalokho, ngesikhathi sokukhiqizwa kwemishini yezokwelapha, izinto zokusetshenziswa, izithasiselo, ama-reaction inhibitors, njll. aqukethe usawoti we-inorganic ngendlela yama-chlorides, futhi lapho inzalo, kungenzeka ukuthi i-ethylene oxide ivula indandatho ngaphansi kwezimo ze-acidic noma ze-alkali, idlula i-SN2. ukusabela, futhi kuhlanganiswe nama-ion angenayo e-chlorine amahhala ukukhiqiza i-2-chloroethanol kufanele kucatshangelwe.
Njengamanje, indlela evame ukusetshenziswa yokuthola i-ethylene oxide, i-2-chloroethanol ne-ethylene glycol yindlela yesigaba segesi.I-ethylene oxide ingaphinda ibonakale ngendlela ye-colorimetric kusetshenziswa isisombululo sokuhlola esibomvu se-sulfite esimpintshiwe, kodwa okubi kwayo ukuthi ubuqiniso bemiphumela yokuhlolwa buthintwa izici eziningi ezimweni zokuhlola, njengokuqinisekisa izinga lokushisa elingaguquki elingu-37°C endaweni yokuhlola. imvelo yokuhlola ukuze kulawulwe ukusabela kwe-ethylene glycol, kanye nesikhathi sokubeka isixazululo ukuze sihlolwe ngemva kwenqubo yokuthuthukisa umbala.Ngakho-ke, ukuqinisekiswa kwendlela okuqinisekisiwe (okuhlanganisa ukunemba, ukunemba, umugqa, ukuzwela, njll.) elabhorethri eqeqeshiwe kuwukubaluleka kwereferensi ekutholweni komthamo wezinsalela.
III.Ukucabanga ngenqubo yokubuyekeza
I-Ethylene oxide, i-2-chloroethanol ne-ethylene glycol yizinsalela ezivamile ngemva kokwenziwa inzalo kwe-ethylene oxide yamadivayisi ezokwelapha.Ukwenza ukuhlolwa kwezinsalela, ukwethulwa kwezinto ezifanele ekukhiqizeni nasekugcinweni kwe-ethylene oxide, ukukhiqizwa kanye nokuvalwa inzalo kwamadivayisi wezokwelapha kufanele kucatshangelwe.
Kunezinye izindaba ezimbili okufanele kugxilwe kuzo emsebenzini wangempela wokubuyekeza idivayisi yezokwelapha: 1. Ukuthi kudingekile yini ukwenza ukuhlolwa kwezinsalela ze-2-chloroethanol.Ekukhiqizeni i-ethylene oxide, uma indlela yendabuko ye-chlorohydrin isetshenziswa, nakuba ukuhlanzwa, ukuhlunga nezinye izindlela kuzokwamukelwa ohlelweni lokukhiqiza, igesi ye-ethylene oxide isazoba nomkhiqizo ophakathi we-2-chloroethanol ngezinga elithile, kanye nenani layo elisele. kufanele ihlolwe.Uma indlela ye-oxidation isetshenziswa, asikho isingeniso se-2-chloroethanol, kodwa inani elisele lama-inhibitors afanelekile, ama-catalysts, njll. ohlelweni lwe-ethylene oxide reaction kufanele lucatshangelwe.Imishini yezokwelapha isebenzisa inani elikhulu lamanzi ezimboni ekukhiqizeni, futhi inani elithile le-hypochlorite ne-chlorine negative ion liyakhangiswa kumkhiqizo oqediwe, okuyizizathu zokuba khona okungenzeka kwe-2-chloroethanol endaweni esele.Kukhona futhi izimo zokuthi izinto zokusetshenziswa kanye nokupakishwa kwemishini yezokwelapha kungusawoti we-inorganic oqukethe i-elemential chlorine noma izinto ze-polymer ezinesakhiwo esizinzile futhi akulula ukugqabula isibopho, njll. Ngakho-ke, kuyadingeka ukuhlaziya ngokucophelela ukuthi ingozi ye-2-chloroethanol izinsalela kufanele zihlolwe ukuze zihlolwe, futhi uma kunobufakazi obanele obubonisa ukuthi ngeke zingeniswe ku-2-chloroethanol noma zingaphansi komkhawulo wokuthola wendlela yokuthola, ukuhlolwa kunganganakwa ukuze kulawulwe ubungozi bakho.2. Okokuhlolwa kwe-ethylene glycol Ukuhlaziya izinsalela.Uma kuqhathaniswa ne-ethylene oxide ne-2-chloroethanol, ubuthi bokuxhumana bezinsalela ze-ethylene glycol buphansi, kodwa ngenxa yokuthi ukukhiqizwa nokusetshenziswa kwe-ethylene oxide nakho kuzovezwa ku-carbon dioxide namanzi, kanti i-ethylene oxide namanzi kujwayele ukukhiqiza i-ethylene glycol, Okuqukethwe kwe-ethylene glycol ngemuva kokuvala inzalo kuhlobene nokuhlanzeka kwe-ethylene oxide, futhi kuhlobene nokupakishwa, umswakama kuma-microorganisms, kanye nezinga lokushisa nomswakama wendawo yokuvala inzalo, ngakho-ke, i-ethylene glycol kufanele ibhekwe ngokuhambisana nezimo zangempela. .Ukuhlola.
Amazinga angelinye lamathuluzi okubuyekezwa kobuchwepheshe bemishini yezokwelapha, ukubuyekezwa kobuchwepheshe kwemishini yezokwelapha kufanele kugxile ezidingweni eziyisisekelo zokuphepha nokusebenza ngempumelelo kokwakhiwa nokuthuthukiswa komkhiqizo, ukukhiqizwa, ukugcinwa, ukusetshenziswa kanye nezinye izici zokuhlaziywa okuphelele kwezinto ezithinta ukuphepha nokusebenza ngempumelelo kwethiyori nokwenza, okusekelwe kusayensi, okusekelwe emaqinisweni, kunokubhekisela ngokuqondile ezingeni, elihlukanisiwe nesimo sangempela sokuklanywa komkhiqizo, ucwaningo nokuthuthukiswa, ukukhiqizwa nokusetshenziswa.Umsebenzi wokubuyekeza kufanele unake kakhulu uhlelo lwekhwalithi yokukhiqiza idivayisi yezokwelapha ukuze kulawulwe izixhumanisi ezifanele, ngesikhathi esifanayo ukubuyekezwa okusendaweni kufanele futhi kugxile “enkingeni”, kunikeze ukudlala okuphelele endimeni “yamehlo” ngcono ikhwalithi yokubuyekezwa, inhloso yokubuyekezwa kwesayensi.
Umthombo: Isikhungo Sokubuyekezwa Kobuchwepheshe Kwamadivayisi Ezokwelapha, Ukulawulwa Kwezidakamizwa Zesifunda (SDA)
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