I. Imvelaphi
Ngokubanzi, izixhobo zonyango ezifakwe inzalo nge-ethylene oxide kufuneka zihlalutywe kwaye zivavanywe kwiintsalela ze-post-sterilization, njengoko inani leentsalela lihambelana ngokusondeleyo nempilo yabo bavezwe kwisixhobo sonyango.I-ethylene oxide yinkqubo ye-nervous central depressant.Ukuba udibane nolusu, ubomvu kunye nokuvuvukala kwenzeka ngokukhawuleza, i-blistering iyenzeka emva kweeyure ezimbalwa, kwaye ukudibanisa ngokuphindaphindiweyo kunokubangela ukuvakalelwa.Ukutshiza ulwelo emehlweni kunokubangela ukutsha kwecorneal.Kwimeko yokuvezwa ixesha elide kwiimali ezincinci, i-neurasthenia syndrome kunye ne-vegetative nerve disorders ingabonwa.Kuye kwaxelwa ukuba i-LD50 yomlomo obukhali kwiigundane yi-330 mg / Kg, kwaye i-ethylene oxide inokunyusa izinga lokuphambuka kwee-chromosome zomongo wethambo kwiigundane [1].Amazinga aphezulu e-carcinogenicity kunye nokufa kuye kwabikwa kubasebenzi abavezwe kwi-ethylene oxide.[2] I-2-Chloroethanol inokubangela i-erythema yesikhumba ukuba idibene nolusu;inokufunxwa nge-percutaneously ukwenza ityhefu.Ukusela ngomlomo kunokuba yingozi.Ukubonakaliswa okungapheliyo kwexesha elide kunokubangela umonakalo kwinkqubo ye-nervous central, inkqubo ye-cardiovascular system kunye nemiphunga.Iziphumo zophando lwasekhaya kunye nezangaphandle kwi-ethylene glycol ziyavuma ukuba ubuthi bayo buphantsi.Inkqubo yemetabolism yayo emzimbeni iyafana naleyo ye-ethanol, ngemetabolism ye-ethanol dehydrogenase kunye ne-acetaldehyde dehydrogenase, iimveliso eziphambili yi-glyoxalic acid, i-oxalic acid kunye ne-lactic acid, enetyhefu ephezulu.Ke ngoko, inani lemigangatho lineemfuno ezithile zeentsalela emva kokwenziwa inzala nge-ethylene oxide.Ngokomzekelo, i-GB/T 16886.7-2015 "Uvavanyo lwe-Biological of Medical Devices Part 7: Ethylene Oxide Sterilization Residues", YY0290.8-2008 "I-Ophthalmic Optics Artificial Lens Icandelo le-8: Iimfuno ezisisiseko", kunye neminye imigangatho ineemfuno ezicacileyo ze iintsalela ze-ethylene oxide kunye ne-2-chloroethanol.GB/T 16886.7-2015 ichaza ngokucacileyo ukuba xa usebenzisa i-GB/T 16886.7-2015, kucaciswe ngokucacileyo ukuba xa i-2-chloroethanol ikhona kwizixhobo zonyango ezifakwe kwi-ethylene oxide, i-residue ephezulu evumelekileyo. kwakhona ngokucacileyo ulinganiselwe.Ngoko ke, kuyimfuneko ukuhlalutya ngokubanzi ukuveliswa kweentsalela eziqhelekileyo (i-ethylene oxide, i-2-chlorethanol, i-ethylene glycol) ukusuka kwimveliso, ukuthutha kunye nokugcinwa kwe-ethylene oxide, ukuveliswa kwezixhobo zonyango, kunye nenkqubo yokuvala inzalo.
II.Uhlalutyo lweentsalela zokuvala inzala
Inkqubo yokuvelisa i-ethylene oxide ihlulwe ngendlela ye-chlorohydrin kunye nendlela ye-oxidation.Phakathi kwabo, indlela ye-chlorohydrin yindlela yokuvelisa i-ethylene oxide yokuqala.Ikakhulu iqulethe iinkqubo ezimbini zokusabela: inyathelo lokuqala: C2H4 + HClO – CH2Cl – CH2OH;inyathelo lesibini: CH2Cl – CH2OH + CaOH2 – C2H4O + CaCl2 + H2O.inkqubo yokusabela kwayo Imveliso ephakathi yi-2-chloroethanol (CH2Cl-CH2OH).Ngenxa yobuchwephesha obungasemva bendlela ye-chlorohydrin, ukungcoliseka okunzulu kokusingqongileyo, kudityaniswa nemveliso yokonakala okukhulu kwezixhobo, uninzi lwabavelisi baphelisiwe [4].Indlela ye-oxidation [3] yohlulwe kwiindlela zomoya kunye ne-oxygen.Ngokutsho kobunyulu obuhlukeneyo be-oksijeni, ukuveliswa kweyona nto iphambili kuqulethe iinkqubo ezimbini zokuphendula: isinyathelo sokuqala: 2C2H4 + O2 - 2C2H4O;inyathelo lesibini: C2H4 + 3O2 – 2CO2 + H2O.okwangoku, ukuveliswa kwemizi-mveliso ye-ethylene oxide Okwangoku, ukuveliswa kwemizi-mveliso ye-ethylene oxide ikakhulu yamkela inkqubo ye-ethylene ngqo ye-oxidation ngesilivere njenge-catalyst.Ngoko ke, inkqubo yokuvelisa i-ethylene oxide yinto emisela ukuvavanywa kwe-2-chloroethanol emva kokuvalwa inzala.
Ngokubhekiselele kumalungiselelo afanelekileyo kumgangatho we-GB / T 16886.7-2015 ukwenza ukuqinisekiswa kunye nophuhliso lwenkqubo ye-ethylene oxide sterilization, ngokweempawu ze-physicochemical ze-ethylene oxide, ininzi yeentsalela zikhona kwifom yokuqala emva kokuvalwa inzala.Izinto ezichaphazela ubungakanani bentsalela zibandakanya i-adsorption ye-ethylene oxide ngezixhobo zonyango, izinto zokupakisha kunye nobukhulu, ubushushu kunye nokufuma ngaphambi nangemva kokuvala inzala, ixesha lokuvala inzala kunye nexesha lesisombululo, iimeko zokugcina, njl. amandla ethylene oxide.Kuye kwaxelwa kwiincwadi [5] ukuba ukuxinwa kwe-ethylene oxide sterilization ngokuqhelekileyo kukhethwe njenge-300-1000mg.L-1.Izinto ezilahlekileyo ze-ethylene oxide ngexesha lokwenziwa inzala zibandakanya ikakhulu: i-adsorption yezixhobo zonyango, i-hydrolysis phantsi kweemeko ezithile zomswakama, njalo njalo.I-concentration ye-500-600mg.L-1 inoqoqosho kwaye iyasebenza, inciphisa ukusetyenziswa kwe-ethylene oxide kunye nentsalela kwizinto ezihlambulukileyo, ukugcina iindleko zokuvala inzala.
I-Chlorine inoluhlu olubanzi lwezicelo kwishishini lemichiza, iimveliso ezininzi zihlobene ngokusondeleyo nathi.Ingasetyenziselwa njengendawo ephakathi, efana ne-vinyl chloride, okanye njengemveliso yokuphela, efana ne-bleach.Ngelo xesha, i-chlorine ikhona emoyeni, emanzini nakweminye imimandla, ingozi emzimbeni womntu nayo ibonakala.Ngoko ke, xa izixhobo zonyango ezifanelekileyo zihlanjululwa yi-ethylene oxide, uhlalutyo olubanzi lwemveliso, ukuvala inzala, ukugcinwa kunye neminye imiba yemveliso kufuneka ithathelwe ingqalelo, kwaye amanyathelo ajoliswe kuyo kufuneka athathwe ukulawula inani eliseleyo le-2-chloroethanol.
Kuye kwaxelwa kuncwadi [6] ukuba umxholo we-2-chloroethanol ufikelele phantse kwi-150 µg/isiqwenga emva kweeyure ezingama-72 zokusonjululwa kwebhendi yoncedo evalwe yi-ethylene oxide, kunye ngokubhekiselele kwizixhobo zoqhagamshelwano zexesha elifutshane ezichaziweyo. kumgangatho we-GB / T16886.7-2015, umyinge we-dose yemihla ngemihla ye-2-chloroethanol kwisigulane akufanele ibe ngaphezu kwe-9 mg, kwaye inani layo elishiyekileyo liphantsi kakhulu kunexabiso lomda kumgangatho.
Uphononongo [7] lulinganisa iintsalela ze-ethylene oxide kunye ne-2-chloroethanol kwiintlobo ezintathu zemisonto ye-suture, kwaye iziphumo ze-ethylene oxide zazingabonakali kwaye i-2-chloroethanol yayiyi-53.7 µg.g-1 kumsonto we-suture ngentambo ye-nayiloni. .I-YY 0167-2005 ichaza umda wokufunyanwa kwe-ethylene oxide kwi-sutures yokuhlinzwa engabonakaliyo, kwaye akukho mmiselo we-2-chloroethanol.I-Sutures inamandla obuninzi bamanzi amashishini kwinkqubo yokuvelisa.Iindidi ezine zomgangatho wamanzi wamanzi ethu aphantsi komhlaba zisebenza kwindawo yokukhusela yoshishino jikelele kunye nomzimba womntu ongadibananga ngokuthe ngqo nommandla wamanzi, ngokuqhelekileyo uphathwa nge-bleach, unokulawula i-algae kunye ne-microorganisms emanzini, esetyenziselwa inzala kunye nokuthintela ubhubhane. .Eyona nto isebenzayo yi-calcium hypochlorite, eyenziwa ngokudlula igesi ye-chlorine kwi-limestone.I-calcium hypochlorite ithotywa ngokulula emoyeni, ifomyula yokusabela ephambili yile: Ca(ClO)2+CO2+H2O–CaCO3+2HClO.I-hypochlorite ichithwa ngokulula ibe yi-hydrochloric acid kunye namanzi phantsi kokukhanya, i-formula enkulu yokusabela yile: 2HClO + ukukhanya-2HCl + O2.I-2HCl + O2.I-Chlorine negative ions ibhengezwa ngokulula kwi-sutures, kwaye phantsi kweendawo ezithile ezinobuthakathaka obune-acidic okanye i-alkaline, i-ethylene oxide ivula i-ring kunye nayo ukuvelisa i-2-chloroethanol.
Kuye kwaxelwa kwiincwadi [8] ukuba intsalela ye-2-chloroethanol kwiisampuli ze-IOL ikhutshwe yi-ultrasonic extraction kunye ne-acetone kwaye inqunywe yigesi ye-chromatography-mass spectrometry, kodwa ayizange ibonwe.YY0290.8-2008 "I-Ophthalmic Optics Artificial I-Lens Icandelo le-8: IiMfuno eziSiseko "lichaza ukuba inani elishiyekileyo le-2-chloroethanol kwi-IOL akufanele libe ngaphezu kwe-2.0µg ngosuku ngelensi nganye, kwaye isixa esipheleleyo selensi nganye akufanele ibe ngaphezu kwe-5.0 I-GB / T16886. Umgangatho we-7-2015 ukhankanya ukuba i-ocular toxicity ebangelwa yi-2-chloroethanol i-residue iphezulu ngamaxesha angama-4 kunokuba ibangelwa kwinqanaba elifanayo le-ethylene oxide.
Isishwankathelo, xa uvavanya iintsalela zezixhobo zonyango emva kokwenziwa inzala nge-ethylene oxide, i-ethylene oxide kunye ne-2-chloroethanol kufuneka igxininise, kodwa iintsalela zabo kufuneka zihlalutywe ngokubanzi ngokwemeko yangempela.
Ngexesha lokwenziwa inzala kwezixhobo zonyango, ezinye zezixhobo zonyango ezisetyenziselwa enye okanye izinto zokupakisha ziquka i-polyvinyl chloride (PVC), kunye nexabiso elincinci kakhulu le-vinyl chloride monomer (VCM) liya kuveliswa ngokubola kwe-PVC resin. ngexesha processing.GB10010-2009 imibhobho zonyango ethambileyo yePVC ichaza ukuba umxholo weVCM awunakudlula i-1µg.g-1.I-VCM i-polymerized ngokulula phantsi kwesenzo se-catalysts (i-peroxides, njl) okanye ukukhanya kunye nobushushu ukuvelisa i-polyvinyl chloride resin, eyaziwa ngokuba yi-vinyl chloride resin.I-vinyl chloride i-polymerized ngokulula phantsi kwesenzo se-catalyst (peroxide, njl.) okanye ukukhanya kunye nobushushu ukuvelisa i-polyvinyl chloride, eyaziwa ngokuba yi-vinyl chloride resin.Xa i-polyvinyl chloride ishushu ngaphezu kwe-100 ° C okanye ibonakaliswe kwimitha ye-ultraviolet, kunokwenzeka ukuba igesi ye-hydrogen chloride ingabaleka.Emva koko udibaniso lwegesi ye-hydrogen chloride kunye ne-ethylene oxide ngaphakathi kwephakheji iya kuvelisa inani elithile le-2-chloroethanol.
I-Ethylene glycol, izinzile kwindalo, ayiguquki.I-athomu yeoksijini ekwi-ethylene oxide ithwala izibini ezimbini zee-electron kwaye ine-hydrophilicity eyomeleleyo, eyenza kube lula ukuvelisa i-ethylene glycol xa ihlala kunye nee-ion ze-chloride ezingalunganga.Umzekelo: C2H4O + NaCl + H2O – CH2Cl – CH2OH + NaOH.le nkqubo ibuthathaka isisiseko kwisiphelo esisebenzayo kwaye isisiseko esinamandla kwisiphelo sokuvelisa, kwaye izehlo zokusabela ziphantsi.Isiganeko esiphezulu kukubunjwa kwe-ethylene glycol kwi-ethylene oxide ekudibaneni namanzi: C2H4O + H2O - CH2OH - CH2OH, kunye ne-hydration ye-ethylene oxide inqanda ukubophelela kwayo kwi-chlorine ion negative negative.
Ukuba i-chlorine ion negative zingeniswa kwimveliso, inzalo, ukugcinwa, ukuthutha kunye nokusetyenziswa kwezixhobo zonyango, kunokwenzeka ukuba i-ethylene oxide iya kusabela kunye nabo ukwenza i-2-chloroethanol.Ekubeni indlela ye-chlorohydrin isusiwe kwinkqubo yokuvelisa, imveliso yayo ephakathi, i-2-chloroethanol, ayiyi kwenzeka kwindlela ye-oxidation ngqo.Kwimveliso yezixhobo zonyango, izinto ezithile eziluhlaza zineepropati eziqinileyo ze-adsorption ze-ethylene oxide kunye ne-2-chloroethanol, ngoko ke ukulawulwa kweemali zabo ezishiyekileyo kufuneka kuthathelwe ingqalelo xa kuhlalutywa emva kokuvalwa inzala.Ukongeza, ngexesha lokuveliswa kwezixhobo zonyango, izinto eziluhlaza, izongezo, i-reaction inhibitors, njl.njl, zineetyuwa ze-inorganic ngendlela ye-chlorides, kwaye xa inzalo inokwenzeka ukuba i-ethylene oxide ivula ikhonkco phantsi kweemeko ze-acidic okanye i-alkaline, idlula kwi-SN2 reaction, kwaye idibanisa simahla chlorine negative ion ukuvelisa 2-chloroethanol kufuneka kuthathelwe ingqalelo.
Okwangoku, indlela esetyenziswa ngokuqhelekileyo yokufumanisa i-ethylene oxide, i-2-chloroethanol kunye ne-ethylene glycol yindlela yesigaba segesi.I-ethylene oxide nayo inokubonwa yindlela ye-colorimetric usebenzisa isisombululo sovavanyo lwe-sulfite epinki ebomvu, kodwa ukungabikho kwayo kukuba ukunyaniseka kweziphumo zovavanyo kuchatshazelwa yimiba emininzi kwiimeko zovavanyo, ezinjengokuqinisekisa ubushushu obungaguqukiyo obuyi-37 ° C kwindawo yovavanyo. indawo yovavanyo ukwenzela ukulawula ukusabela kwe-ethylene glycol, kunye nexesha lokubeka isisombululo ukuba sivavanywe emva kwenkqubo yokuphuhlisa umbala.Ke ngoko, ukuqinisekiswa kwenkqubo eqinisekisiweyo (kubandakanya ukuchaneka, ukuchaneka, ukuhambelana, uvakalelo, njl.njl.) kwibhubhoratri eqinisekisiweyo yokubaluleka kwereferensi yokufumanisa ubungakanani beentsalela.
III.Iingcamango kwinkqubo yophononongo
I-Ethylene oxide, i-2-chloroethanol kunye ne-ethylene glycol ziintsalela eziqhelekileyo emva kwe-ethylene oxide sterilization yezixhobo zonyango.Ukwenza uvavanyo lwentsalela, ukuqaliswa kwezinto ezifanelekileyo kwimveliso kunye nokugcinwa kwe-ethylene oxide, ukuveliswa kunye ne-sterilization yezixhobo zonyango kufuneka ziqwalaselwe.
Kukho eminye imiba emibini ekufuneka igxininiswe kuyo kumsebenzi wophononongo lwesixhobo sonyango: 1. Ingaba kuyimfuneko ukwenza uvavanyo lweentsalela ze-2-chloroethanol.Kwimveliso ye-ethylene oxide, ukuba indlela ye-chlorohydrin yendabuko isetyenzisiweyo, nangona ukuhlanjululwa, ukuhluzwa kunye nezinye iindlela ziya kwamkelwa kwinkqubo yokuvelisa, igesi ye-ethylene oxide iya kuhlala iqulethe imveliso ephakathi kwe-2-chloroethanol ukuya kwinqanaba elithile, kunye nemali eseleyo. kufuneka ivavanywe.Ukuba indlela ye-oxidation isetyenzisiweyo, akukho ngeniso ye-2-chloroethanol, kodwa inani eliseleyo le-inhibitors efanelekileyo, i-catalysts, njl. kwinkqubo yokuphendula i-ethylene oxide kufuneka ithathelwe ingqalelo.Izixhobo zonyango zisebenzisa isixa esikhulu samanzi amashishini kwinkqubo yokuvelisa, kwaye inani elithile le-hypochlorite kunye ne-chlorine ion negative nazo zibhengezwa kwimveliso egqityiweyo, ezi zizathu zobukho obunokwenzeka be-2-chloroethanol kwintsalela.Kukho kwakhona iimeko ukuba izinto ekrwada kunye nokupakishwa izixhobo zonyango iityuwa inorganic eziqulathe elemental chlorine okanye polymer izinto ngesakhiwo oluzinzileyo kwaye akukho lula ukwaphula ibhondi, njl. Ngoko ke, kuyimfuneko ukuhlalutya ngokubanzi ukuba umngcipheko 2-chloroethanol i-residu kufuneka ihlolwe ukuvavanya, kwaye ukuba kukho ubungqina obaneleyo bokubonisa ukuba ayiyi kufakwa kwi-2-chloroethanol okanye iphantsi kunomda wokufumanisa indlela yokufumanisa, uvavanyo lunokungahoywa ukulawula umngcipheko walo.2. Kuvavanyo lwe-ethylene glycol yeentsalela.Xa kuthelekiswa ne-ethylene oxide kunye ne-2-chloroethanol, ityhefu yoqhagamshelwano yeentsalela ze-ethylene glycol iphantsi, kodwa ngenxa yokuba imveliso ye-ethylene oxide kunye nokusetyenziswa nayo iya kuboniswa kwi-carbon dioxide namanzi, kwaye i-ethylene oxide kunye namanzi iyakwazi ukuvelisa i-ethylene glycol, kwaye Isiqulatho se-ethylene glycol emva kokwenziwa inzala inxulumene nokucoceka kwe-ethylene oxide, kwaye inxulumene nokupakishwa, ukufuma kwi-microorganisms, kunye nobushushu kunye nokufuma okusingqongileyo kwe-sterrilization, ngoko ke, i-ethylene glycol kufuneka iqwalaselwe ngokuhambelana neemeko zangempela. .Uvavanyo.
Imigangatho yenye yezixhobo zokuphononongwa kobugcisa bezixhobo zonyango, ukuphononongwa kobugcisa bezixhobo zonyango kufuneka kugxininise kwiimfuno ezisisiseko zokhuseleko kunye nokusebenza kakuhle koyilo lwemveliso kunye nophuhliso, ukuveliswa, ukugcinwa, ukusetyenziswa kunye neminye imiba yohlalutyo olubanzi lwezinto ezichaphazelayo. ukhuseleko kunye nokusebenza kwethiyori kunye nokusebenza, ngokusekelwe kwisayensi, esekelwe kwiinyani, kunokuba kubhekiselwe ngokuthe ngqo kumgangatho, okhutshwe kwimeko yokwenene yoyilo lwemveliso, uphando kunye nophuhliso, imveliso kunye nokusetyenziswa.Umsebenzi wophononongo kufuneka uhlawule ingqalelo ngakumbi kwinkqubo yomgangatho wemveliso yesixhobo sonyango solawulo lweekhonkco ezifanelekileyo, kwangaxeshanye ukuphononongwa kwendawo kufuneka kwakhona kube "yingxaki" ejolise, inike umdlalo opheleleyo kwindima "yamehlo" ukuphucula umgangatho wophononongo, injongo yokuphononongwa kwezenzululwazi.
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