I. Keeb kwm
Feem ntau, cov khoom siv kho mob ua kom tsis muaj menyuam nrog ethylene oxide yuav tsum tau tshuaj xyuas thiab tshuaj xyuas rau cov khoom seem tom qab ua kom tsis muaj menyuam, vim tias cov seem seem muaj feem cuam tshuam rau kev noj qab haus huv ntawm cov khoom siv kho mob.Ethylene oxide yog lub hauv paus paj hlwb kev nyuaj siab.Yog tias tiv tauj nrog daim tawv nqaij, liab thiab o tshwm sim sai, blistering tshwm sim tom qab ob peb teev, thiab rov qab sib cuag tuaj yeem ua rau rhiab heev.Txau cov kua rau hauv qhov muag tuaj yeem ua rau pob txha hlawv.Nyob rau hauv cov ntaub ntawv ntawm ntev raug rau me me, neurasthenia syndrome thiab vegetative paj hlwb tuaj yeem pom.Nws tau raug tshaj tawm tias qhov mob qhov ncauj LD50 hauv nas yog 330 mg / Kg, thiab cov ethylene oxide tuaj yeem ua rau muaj qhov tsis zoo ntawm cov pob txha pob txha chromosomes hauv nas [1].Cov kab mob carcinogenic ntau dua thiab kev tuag tau raug tshaj tawm hauv cov neeg ua haujlwm raug ethylene oxide.[2] 2-Chloroethanol tuaj yeem ua rau daim tawv nqaij erythema yog nyob rau hauv kev sib cuag nrog daim tawv nqaij;nws tuaj yeem nqus tau percutaneously ua rau lom.Qhov ncauj noj yuav ua rau tuag taus.Kev mob ntev ntev tuaj yeem ua rau muaj kev puas tsuaj rau lub hauv nruab nrab lub paj hlwb, lub plawv thiab lub ntsws.Kev tshawb fawb hauv tsev thiab txawv teb chaws ntawm ethylene glycol pom zoo tias nws tus kheej toxicity tsawg.Nws cov txheej txheem metabolism hauv lub cev yog tib yam li ntawm ethanol, los ntawm cov metabolism hauv ethanol dehydrogenase thiab acetaldehyde dehydrogenase, cov khoom tseem ceeb yog glyoxalic acid, oxalic acid thiab lactic acid, uas muaj toxicity ntau dua.Yog li ntawd, ntau tus qauv muaj cov cai tshwj xeeb rau cov seem tom qab ua kom tsis muaj menyuam los ntawm ethylene oxide.Piv txwv li, GB/T 16886.7-2015 "Kev Ntsuam Xyuas Kev Khomob ntawm Cov Khoom Siv Khomob Ntu 7: Ethylene Oxide Sterilization Residues", YY0290.8-2008 "Ophthalmic Optics Artificial Lens Part 8: Basic Requirements", thiab lwm yam qauv muaj cov ncauj lus kom ntxaws txog kev txwv ntawm cov seem ntawm ethylene oxide thiab 2-chloroethanol.GB/T 16886.7-2015 qhia meej tias thaum siv GB/T 16886.7-2015, nws tau hais meej meej tias thaum 2-chloroethanol muaj nyob rau hauv cov khoom siv kho mob sterilized los ntawm ethylene oxide, nws qhov siab tshaj plaws tso cai residue. tseem muaj kev txwv kom meej.Yog li ntawd, nws yog ib qho tsim nyog yuav tsum ua tib zoo txheeb xyuas qhov tsim cov khoom seem (ethylene oxide, 2-chloroethanol, ethylene glycol) los ntawm kev tsim khoom, kev thauj mus los thiab khaws cia ntawm ethylene oxide, kev tsim cov khoom siv kho mob, thiab kev ua kom tsis muaj menyuam.
II.Kev soj ntsuam ntawm sterilization residues
Cov txheej txheem ntau lawm ntawm ethylene oxide yog muab faib ua chlorohydrin txoj kev thiab oxidation txoj kev.Ntawm lawv, chlorohydrin txoj kev yog txoj kev tsim cov ethylene oxide thaum ntxov.Nws tsuas yog muaj ob txoj kev tshuaj tiv thaiv: thawj kauj ruam: C2H4 + HClO - CH2Cl - CH2OH;theem ob: CH2Cl – CH2OH + CaOH2 – C2H4O + CaCl2 + H2O.Nws cov txheej txheem tshuaj tiv thaiv Cov khoom nruab nrab yog 2-chloroethanol (CH2Cl-CH2OH).Vim hais tias ntawm cov cuab yeej rov qab ntawm chlorohydrin txoj kev, muaj kuab paug loj ntawm ib puag ncig, ua ke nrog cov khoom ntawm cov khoom siv corrosion loj, feem ntau cov tuam ntxhab tau raug tshem tawm [4].Txoj kev oxidation [3] muab faib ua cua thiab oxygen txoj kev.Raws li qhov sib txawv purity ntawm oxygen, qhov tsim ntawm lub ntsiab muaj ob txheej txheem tshuaj tiv thaiv: thawj kauj ruam: 2C2H4 + O2 - 2C2H4O;Cov kauj ruam thib ob: C2H4 + 3O2 - 2CO2 + H2O.Tam sim no, kev tsim khoom ntawm ethylene oxide tam sim no, kev tsim khoom ntawm ethylene oxide tsuas yog siv cov txheej txheem ethylene ncaj qha oxidation nrog nyiaj raws li cov catalyst.Yog li, cov txheej txheem tsim khoom ntawm ethylene oxide yog qhov tseem ceeb uas txiav txim siab qhov kev ntsuam xyuas ntawm 2-chloroethanol tom qab ua kom tsis muaj menyuam.
Xa mus rau cov kev cai cuam tshuam hauv GB / T 16886.7-2015 tus qauv txhawm rau ua tiav qhov kev lees paub thiab kev txhim kho ntawm cov txheej txheem ethylene oxide sterilization, raws li cov khoom siv hluav taws xob ntawm ethylene oxide, feem ntau ntawm cov seem muaj nyob hauv daim ntawv qub tom qab ua kom tsis muaj menyuam.Cov yam ntxwv cuam tshuam rau cov khoom seem feem ntau suav nrog cov adsorption ntawm ethylene oxide los ntawm cov khoom siv kho mob, cov khoom ntim thiab cov tuab, kub thiab av noo ua ntej thiab tom qab ua kom tsis muaj menyuam, lub sijhawm ua kom tsis muaj menyuam thiab lub sijhawm daws teeb meem, cov xwm txheej khaws cia, thiab lwm yam, thiab cov xwm txheej saum toj no txiav txim siab kev khiav tawm. muaj peev xwm ntawm ethylene oxide.Nws tau raug tshaj tawm nyob rau hauv cov ntaub ntawv [5] tias cov concentration ntawm ethylene oxide sterilization feem ntau yog xaiv li 300-1000mg.L-1.Qhov poob ntawm ethylene oxide thaum ua kom tsis muaj menyuam feem ntau suav nrog: adsorption ntawm cov cuab yeej kho mob, hydrolysis nyob rau hauv qee qhov av noo, thiab lwm yam.Cov concentration ntawm 500-600mg.L-1 kuj yog kev lag luam thiab siv tau zoo, txo kev noj cov ethylene oxide thiab cov seem ntawm cov khoom tsis muaj menyuam, txuag cov nqi kom tsis muaj menyuam.
Chlorine muaj ntau yam kev siv hauv kev lag luam tshuaj, ntau yam khoom muaj feem xyuam nrog peb.Nws tuaj yeem siv los ua qhov nruab nrab, xws li vinyl chloride, lossis ua cov khoom kawg, xws li tshuaj dawb.Nyob rau tib lub sijhawm, chlorine kuj muaj nyob hauv huab cua, dej thiab lwm qhov chaw, kev ua phem rau tib neeg lub cev kuj pom tseeb.Yog li, thaum cov khoom siv kho mob cuam tshuam tau ua kom tsis muaj menyuam los ntawm ethylene oxide, kev tshuaj xyuas dav dav ntawm kev tsim khoom, kom tsis muaj menyuam, kev cia thiab lwm yam ntawm cov khoom yuav tsum tau txiav txim siab, thiab cov phiaj xwm ntsuas yuav tsum tau coj los tswj cov seem ntawm 2-chloroethanol.
Nws tau raug tshaj tawm nyob rau hauv cov ntaub ntawv [6] tias cov ntsiab lus ntawm 2-chloroethanol mus txog ze li ntawm 150 µg / thooj tom qab 72 teev ntawm kev daws teeb meem ntawm band-pab thaj ua rau kom tsis muaj menyuam los ntawm ethylene oxide, thiab nrog rau kev siv rau cov khoom siv tiv tauj luv luv tau teev tseg. nyob rau hauv tus qauv ntawm GB / T16886.7-2015, qhov nruab nrab koob tshuaj txhua hnub ntawm 2-chloroethanol rau tus neeg mob yuav tsum tsis txhob ntau tshaj 9 mg, thiab nws cov nyiaj seem tshuav tsawg dua li tus nqi txwv hauv tus qauv.
Ib txoj kev tshawb no [7] ntsuas cov seem ntawm ethylene oxide thiab 2-chloroethanol nyob rau hauv peb hom suture threads, thiab cov txiaj ntsig ntawm ethylene oxide tsis-detectable thiab 2-chloroethanol yog 53.7 µg.g-1 rau cov xov suture nrog nylon xov. .YY 0167-2005 qhia txog qhov txwv ntawm kev tshawb pom rau ethylene oxide rau kev phais phais uas tsis tuaj yeem nqus tau, thiab tsis muaj kev cai rau 2-chloroethanol.Sutures muaj peev xwm ua kom muaj dej ntau hauv cov txheej txheem tsim khoom.Plaub pawg ntawm cov dej zoo ntawm peb cov dej hauv av siv tau rau thaj chaw muaj kev tiv thaiv dav dav thiab tib neeg lub cev tsis sib cuag nrog thaj chaw dej, feem ntau kho nrog tshuaj dawb, tuaj yeem tswj cov algae thiab cov kab mob hauv dej, siv rau kev ua kom tsis muaj menyuam thiab tiv thaiv kev kis kab mob. .Nws lub ntsiab active ingredient yog calcium hypochlorite, uas yog generated los ntawm kis chlorine gas los ntawm limestone.Calcium hypochlorite yog yooj yim degraded nyob rau hauv cov huab cua, lub ntsiab cov tshuaj tiv thaiv mis yog: Ca(ClO)2 + CO2 + H2O–CaCO3 + 2HClO.hypochlorite yog yooj yim decomposed rau hauv hydrochloric acid thiab dej nyob rau hauv lub teeb, lub ntsiab cov tshuaj tiv thaiv mis yog: 2HClO + lub teeb - 2HCl + O2.2HCl + O2.Chlorine tsis zoo ions yog yooj yim adsorbed nyob rau hauv sutures, thiab nyob rau hauv tej yam weakly acidic los yog alkaline ib puag ncig, ethylene oxide qhib lub nplhaib nrog nws los tsim 2-chloroethanol.
Nws tau raug tshaj tawm nyob rau hauv cov ntaub ntawv [8] tias cov seem 2-chloroethanol ntawm IOL kuaj tau muab rho tawm los ntawm ultrasonic extraction nrog acetone thiab txiav txim siab los ntawm roj chromatography-mass spectrometry, tab sis nws tsis tau kuaj pom.YY0290.8-2008 "Ophthalmic Optics Artificial Lens Part 8: Basic Requirements "hais tias cov seem ntawm 2-chloroethanol ntawm IOL yuav tsum tsis txhob ntau tshaj 2.0µg ib hnub twg rau ib lub lens, thiab tag nrho cov nyiaj ntawm txhua lub lens yuav tsum tsis txhob ntau tshaj 5.0 GB / T16886. 7-2015 tus qauv hais tias qhov ocular toxicity tshwm sim los ntawm 2-chloroethanol residue yog 4 npaug siab dua qhov uas tshwm sim los ntawm tib theem ntawm ethylene oxide.
Hauv cov ntsiab lus, thaum ntsuas qhov seem ntawm cov khoom siv kho mob tom qab ua kom tsis muaj menyuam los ntawm ethylene oxide, ethylene oxide thiab 2-chloroethanol yuav tsum tau tsom mus rau, tab sis lawv cov seem yuav tsum tau txheeb xyuas kom meej raws li qhov tseeb.
Thaum lub sij hawm ua kom tsis muaj menyuam ntawm cov khoom siv kho mob, qee cov khoom siv rau kev kho mob ib leeg lossis cov khoom ntim muaj xws li polyvinyl chloride (PVC), thiab tsawg heev ntawm vinyl chloride monomer (VCM) kuj yuav raug tsim los ntawm kev decomposition ntawm PVC resin. Thaum lub sij hawm ua.GB10010-2009 kho mob cov kav dej PVC qhia tias cov ntsiab lus ntawm VCM tsis tuaj yeem tshaj 1µg.g-1.VCM yog yooj yim polymerized nyob rau hauv qhov kev txiav txim ntawm catalysts (peroxides, thiab lwm yam) los yog lub teeb thiab tshav kub los tsim polyvinyl chloride resin, collectively hu ua vinyl chloride resin.Vinyl chloride yog yooj yim polymerized nyob rau hauv qhov kev txiav txim ntawm catalyst (peroxide, thiab lwm yam) los yog lub teeb thiab cua sov los tsim polyvinyl chloride, collectively hu ua vinyl chloride resin.Thaum polyvinyl chloride yog cua sov siab tshaj 100 ° C los yog raug rau cov hluav taws xob ultraviolet, muaj peev xwm ua kom cov pa roj hydrogen chloride yuav dim.Tom qab ntawd kev sib xyaw ntawm hydrogen chloride roj thiab ethylene oxide nyob rau hauv lub pob yuav tsim ib qho nyiaj ntawm 2-chloroethanol.
Ethylene glycol, ruaj khov nyob rau hauv qhov, tsis yog volatile.Cov pa oxygen atom hauv ethylene oxide nqa ob leeg ib khub ntawm electrons thiab muaj zog hydrophilicity, uas ua rau nws yooj yim dua los tsim ethylene glycol thaum coexisting nrog tsis zoo chloride ions.Piv txwv li: C2H4O + NaCl + H2O – CH2Cl – CH2OH + NaOH.Cov txheej txheem no tsis muaj zog hauv qhov kawg ntawm qhov reactive thiab muaj zog hauv qhov kawg ntawm qhov kawg, thiab qhov tshwm sim ntawm cov tshuaj tiv thaiv no tsawg.Qhov tshwm sim ntau dua yog qhov tsim ntawm ethylene glycol los ntawm ethylene oxide nyob rau hauv kev sib cuag nrog dej: C2H4O + H2O - CH2OH - CH2OH, thiab hydration ntawm ethylene oxide inhibits nws khi rau dawb chlorine tsis zoo ions.
Yog tias cov tshuaj chlorine tsis zoo ions tau qhia hauv kev tsim khoom, kev ua kom tsis muaj menyuam, kev cia khoom, kev thauj mus los thiab kev siv cov cuab yeej kho mob, muaj peev xwm ua rau ethylene oxide yuav ua rau lawv ua 2-chloroethanol.Txij li thaum txoj kev chlorohydrin raug tshem tawm los ntawm cov txheej txheem tsim khoom, nws cov khoom nruab nrab, 2-chloroethanol, yuav tsis tshwm sim hauv txoj kev oxidation ncaj qha.Hauv kev tsim cov khoom siv kho mob, qee cov ntaub ntawv raw muaj zog adsorption zog rau ethylene oxide thiab 2-chloroethanol, yog li kev tswj hwm ntawm lawv cov seem seem yuav tsum tau txiav txim siab thaum soj ntsuam lawv tom qab kom tsis muaj menyuam.Tsis tas li ntawd, thaum tsim cov khoom siv kho mob, cov khoom siv raw, cov khoom siv ntxiv, cov tshuaj tiv thaiv cov tshuaj tiv thaiv, thiab lwm yam muaj cov ntsev inorganic hauv daim ntawv ntawm cov tshuaj chlorides, thiab thaum ua kom tsis muaj menyuam, qhov muaj peev xwm ntawm ethylene oxide qhib lub nplhaib nyob rau hauv acidic lossis alkaline tej yam kev mob, undergoes SN2. cov tshuaj tiv thaiv, thiab ua ke nrog dawb chlorine tsis zoo ions los tsim 2-chloroethanol yuav tsum tau txiav txim siab.
Tam sim no, feem ntau siv txoj hauv kev los ntsuas ethylene oxide, 2-chloroethanol thiab ethylene glycol yog cov roj theem.Ethylene oxide kuj tuaj yeem kuaj pom los ntawm txoj kev colorimetric siv pinched liab sulfite test tov, tab sis nws qhov tsis zoo yog tias qhov tseeb ntawm qhov kev xeem tau raug cuam tshuam los ntawm ntau yam hauv kev sim, xws li kom ntseeg tau qhov kub thiab txias ntawm 37 ° C hauv qhov ntsuas kub. kev sim ib puag ncig thiaj li tswj tau cov tshuaj tiv thaiv ntawm ethylene glycol, thiab lub sijhawm tso cov tshuaj yuav tsum tau kuaj tom qab cov txheej txheem tsim xim.Yog li ntawd, paub tseeb tias txoj kev siv tau (nrog rau qhov tseeb, qhov tseeb, linearity, rhiab heev, thiab lwm yam) nyob rau hauv ib lub chaw soj nstuam tsim nyog yog qhov tseem ceeb rau kev tshawb nrhiav kom muaj nuj nqis.
III.Reflections ntawm tus txheej txheem tshuaj xyuas
Ethylene oxide, 2-chloroethanol thiab ethylene glycol yog cov seem seem tom qab ethylene oxide sterilization ntawm cov cuab yeej kho mob.Txhawm rau ua qhov kev ntsuam xyuas cov khoom seem, kev qhia txog cov khoom siv hauv kev tsim khoom thiab khaws cia ntawm ethylene oxide, kev tsim khoom thiab kev ua kom tsis muaj menyuam ntawm cov khoom siv kho mob yuav tsum raug txiav txim siab.
Muaj ob qhov teeb meem uas yuav tsum tau tsom mus rau hauv kev tshuaj xyuas cov cuab yeej kho mob tiag tiag: 1. Txawm hais tias nws yuav tsum tau ua qhov kev sim ntawm cov seem ntawm 2-chloroethanol.Hauv kev tsim cov ethylene oxide, yog siv cov tshuaj chlorohydrin ib txwm siv, txawm hais tias kev ua kom huv, pom thiab lwm txoj hauv kev yuav raug coj los siv hauv cov txheej txheem tsim khoom, cov roj ethylene oxide tseem yuav muaj cov khoom nruab nrab ntawm 2-chloroethanol rau qee qhov, thiab nws cov seem seem. yuav tsum tau soj ntsuam.Yog tias siv txoj kev oxidation, tsis muaj kev qhia txog 2-chloroethanol, tab sis cov seem seem ntawm cov tshuaj inhibitors, catalysts, thiab lwm yam hauv cov txheej txheem ethylene oxide cov tshuaj tiv thaiv yuav tsum tau txiav txim siab.Cov khoom siv kho mob siv cov dej ntau hauv cov txheej txheem tsim khoom, thiab qee qhov ntawm hypochlorite thiab chlorine tsis zoo ions kuj adsorbed hauv cov khoom tiav, uas yog vim li cas rau qhov muaj peev xwm ntawm 2-chloroethanol nyob rau hauv seem.Tseem muaj cov xwm txheej uas cov khoom siv raw thiab ntim cov khoom siv kho mob yog cov ntsev inorganic uas muaj cov tshuaj chlorine lossis cov khoom siv polymer nrog cov qauv ruaj khov thiab tsis yooj yim rau kev tawg ntawm daim ntawv cog lus, thiab lwm yam. Yog li ntawd, nws yog ib qho tsim nyog yuav tsum ua tib zoo tshuaj xyuas seb qhov kev pheej hmoo ntawm 2-chloroethanol. residue yuav tsum tau kuaj rau kev soj ntsuam, thiab yog tias muaj pov thawj txaus los qhia tias nws yuav tsis nkag mus rau hauv 2-chloroethanol lossis qis dua qhov kev txwv tsis pub tshaj ntawm txoj kev tshawb nrhiav, qhov kev ntsuam xyuas tuaj yeem tsis lees paub los tswj kev pheej hmoo ntawm nws.2. Rau cov ethylene glycol Analytical soj ntsuam ntawm residues.Piv nrog ethylene oxide thiab 2-chloroethanol, kev sib cuag toxicity ntawm ethylene glycol residues qis dua, tab sis vim ethylene oxide tsim thiab siv kuj yuav raug rau carbon dioxide thiab dej, thiab ethylene oxide thiab dej yog nquag tsim ethylene glycol, thiab cov Cov ntsiab lus ntawm ethylene glycol tom qab ua kom tsis muaj menyuam muaj feem xyuam nrog kev ua kom huv ntawm ethylene oxide, thiab tseem muaj feem xyuam nrog kev ntim khoom, cov dej noo hauv cov kab mob, thiab qhov kub thiab av noo ib puag ncig ntawm kev ua kom tsis muaj menyuam, yog li ntawd, ethylene glycol yuav tsum tau txiav txim siab raws li qhov xwm txheej. .Kev ntsuam xyuas.
Cov qauv yog ib qho ntawm cov cuab yeej rau kev tshuaj xyuas cov cuab yeej siv kho mob, kev tshuaj xyuas cov cuab yeej siv kho mob yuav tsum tsom mus rau cov kev cai yooj yim ntawm kev nyab xeeb thiab kev ua tau zoo ntawm cov khoom tsim thiab kev tsim kho, kev tsim khoom, kev cia khoom, kev siv thiab lwm yam ntawm kev txheeb xyuas cov ntsiab lus cuam tshuam. kev nyab xeeb thiab kev ua tau zoo ntawm txoj kev xav thiab kev coj ua, raws li kev tshawb fawb, raws li qhov tseeb, tsis yog siv ncaj qha rau tus qauv, cais tawm ntawm qhov tseeb ntawm cov khoom tsim, kev tshawb fawb thiab kev tsim kho, kev tsim khoom thiab kev siv.Kev tshuaj xyuas kev ua haujlwm yuav tsum tau them nyiaj ntau dua rau cov cuab yeej siv kho mob tsim khoom zoo rau kev tswj hwm cov kev sib txuas, tib lub sijhawm kev tshuaj xyuas ntawm qhov chaw yuav tsum yog "teeb meem" taw qhia, muab kev ua si tag nrho rau lub luag haujlwm ntawm "qhov muag" rau. txhim kho qhov zoo ntawm kev tshuaj xyuas, lub hom phiaj ntawm kev tshuaj xyuas kev tshawb fawb.
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Post lub sij hawm: Sep-21-2023