I. Background
Kazhinji, mishonga yezvokurapa yakasvibiswa ne ethylene oxide inofanira kuongororwa uye kuongororwa kune zvakasara mushure mekuita sterilization, sezvo uwandu hwemasara huri pedyo nehutano hweavo vanoonekwa kune mishonga yekurapa.Ethylene oxide ndiyo inonzi central nervous system depressant.Kana yakabatwa neganda, kutsvuka uye kuzvimba kunoitika nekukurumidza, kuputika kunoitika mushure memaawa mashoma, uye kudzokororwa kubata kunogona kukonzera sensitization.Kumwaya mvura mumaziso kunogona kukonzera kupisa kwekona.Muchiitiko chekugara kwenguva refu kune zviduku zvishoma, neurasthenia syndrome uye vegetative nerve disorders inogona kuonekwa.Izvo zvakataurwa kuti acute oral LD50 mumakonzo ndeye 330 mg/Kg, uye kuti ethylene oxide inogona kuwedzera mwero wekukanganisa kwemapfupa ekromosomes mumakonzo [1].Huwandu hwepamusoro hwecarcinogenicity uye kufa kwave kushumwa muvashandi vakafumurwa kune ethylene oxide.[2] 2-Chloroethanol inogona kukonzera erythema yeganda kana yakasangana neganda;inogona kutorwa percutaneously kukonzera chepfu.Kunwa nemuromo kunogona kuuraya.Kugara kwenguva refu kuratidzwa kunogona kukonzera kukuvadzwa kune yepakati tsinga system, yemoyo system uye mapapu.Tsvagiridzo yemumba neyekunze inobuda pa ethylene glycol inobvuma kuti huturu hwayo hwakaderera.Maitiro ayo emetabolism mumuviri akafanana neethanol, kuburikidza nemetabolism ye ethanol dehydrogenase uye acetaldehyde dehydrogenase, zvigadzirwa zvikuru ndeye glyoxalic acid, oxalic acid uye lactic acid, ine huturu hwepamusoro.Naizvozvo, huwandu hwezviyero zvine chaiwo zvinodiwa kune zvakasara mushure mekuita sterilization ne ethylene oxide.Semuyenzaniso, GB/T 16886.7-2015 “Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residues”, YY0290.8-2008 “Ophthalmic Optics Artificial Lens Chikamu 8: Basic Requirements”, uye mamwe mazinga ane zvakadzama zvinodiwa yezvakasara zve ethylene oxide uye 2-chloroethanol.GB/T 16886.7-2015 inotaura zvakajeka kuti kana uchishandisa GB/T 16886.7-2015, zvinonyatsotaurwa kuti kana 2-chloroethanol iripo mumishonga yezvokurapa yakasvibiswa ne ethylene oxide, iyo yakawanda inobvumirwa residu. akaganhurirwawo zvakajeka.Naizvozvo, zvinodikanwa kunyatsoongorora kugadzirwa kwezvisaririra zvakajairika (ethylene oxide, 2-chloroethanol, ethylene glycol) kubva mukugadzirwa, kutakurwa uye kuchengetwa kwe ethylene oxide, kugadzirwa kwemidziyo yekurapa, uye maitiro esterilization.
II.Ongororo yezvisaririra zvesterilization
Maitiro ekugadzira ethylene oxide akakamurwa kuita chlorohydrin nzira uye oxidation nzira.Pakati pavo, chlorohydrin nzira ndiyo yekutanga ethylene oxide nzira yekugadzira.Inonyanya kuve nemaitiro maviri ekuita: danho rekutanga: C2H4 + HClO - CH2Cl - CH2OH;danho rechipiri: CH2Cl – CH2OH + CaOH2 – C2H4O + CaCl2 + H2O.maitiro ayo maitiro Chigadzirwa chepakati ndeye 2-chloroethanol (CH2Cl-CH2OH).Nekuda kwekudzokera kumashure tekinoroji yechlorohydrin nzira, kusvibiswa kwakakomba kwenzvimbo, pamwe chete nechigadzirwa chekuora kwakanyanya kwemidziyo, vagadziri vazhinji vakabviswa [4].Iyo oxidation nzira [3] yakakamurwa kuita mhepo uye okisijeni nzira.Maererano nekuchena kwakasiyana kweokisijeni, kugadzirwa kweiyo huru ine maitiro maviri ekuita: danho rekutanga: 2C2H4 + O2 - 2C2H4O;danho rechipiri: C2H4 + 3O2 - 2CO2 + H2O.parizvino, kugadzirwa kwemaindasitiri ethylene oxide Parizvino, kugadzirwa kwemaindasitiri ethylene oxide kunonyanya kutora ethylene yakananga oxidation process nesirivheri sechinhu chinokonzeresa.Naizvozvo, maitiro ekugadzira ethylene oxide chinhu chinotarisisa kuongororwa kwe2-chloroethanol mushure mekuita sterilization.
Tichireva kune zvinodiwa muiyo GB/T 16886.7-2015 chiyero chekuita chisimbiso nekuvandudzwa kweiyo ethylene oxide sterilization process, zvichienderana neiyo physicochemical properties ye ethylene oxide, akawanda emasara aripo muchimiro chepakutanga mushure mekuita sterilization.Zvinhu zvinokanganisa huwandu hwezvakasara zvinosanganisira adsorption ye ethylene oxide nemidziyo yekurapa, zvekurongedza zvinhu uye ukobvu, tembiricha uye hunyoro pamberi uye mushure mekuita sterilization, sterilization chiitiko nguva uye nguva yekugadzirisa, mamiriro ekuchengetedza, nezvimwewo, uye zviri pamusoro apa zvinoratidza kutiza. kukwanisa kwe ethylene oxide.Izvo zvakataurwa mumabhuku [5] kuti kusanganiswa kwe ethylene oxide sterilization inowanzosarudzwa se 300-1000mg.L-1.Kurasikirwa kwezvinhu zve ethylene oxide panguva ye sterilization inonyanya kusanganisira: adsorption yezvigadzirwa zvekurapa, hydrolysis pasi pemamwe mamiriro ekunyorova, zvichingodaro.Iko kusanganiswa kwe500-600mg.L-1 ine mari uye inoshanda, inoderedza kushandiswa kwe ethylene oxide uye yakasara pane zvinhu zvakasvibiswa, kuchengetedza mari yesterilization.
Chlorine ine huwandu hwakawanda hwekushandisa muindasitiri yemakemikari, zvigadzirwa zvakawanda zvine hukama nesu.Inogona kushandiswa seyepakati, senge vinyl chloride, kana sechigadzirwa chekupedzisira, senge bleach.Panguva imwecheteyo, chlorine inowanikwawo mumhepo, mvura uye dzimwe nzvimbo, kukuvadza kumuviri wemunhu kunoonekwawo.Naizvozvo, kana michina yekurapa yakakodzera yakavharwa ne ethylene oxide, ongororo yakazara yekugadzirwa, sterilization, kuchengetedza uye zvimwe zvinhu zvechigadzirwa zvinofanirwa kutariswa, uye matanho anonangwa anofanirwa kutorwa kudzora huwandu hwasara hwe2-chloroethanol.
Zvakataurwa mumabhuku [6] kuti zviri mu2-chloroethanol zvakasvika kunosvika 150 µg/chidimbu mushure memaawa makumi manomwe nemaviri ekugadziriswa kwebhendi-yekubatsira patch yakasvibiswa ne ethylene oxide, uye nekutarisa kune yenguva pfupi yekubatanidza michina yakatemwa. muyero yeGB/T16886.7-2015, chiyero chezuva nezuva che2-chloroethanol kumurwere hachifaniri kunge chinopfuura 9 mg, uye yakasara yakawanda yakaderera kudarika kukosha kwemuganhu muyero.
Chidzidzo [7] chakayera zvakasara zveethylene oxide uye 2-chloroethanol mumhando nhatu dzeshinda dzesuture, uye mhedzisiro yeethylene oxide yakanga isingaonekwe uye 2-chloroethanol yaive 53.7 µg.g-1 yeshinda yesuture ine shinda yenaironi. .YY 0167-2005 inotaura muganhu wekuonekwa kwe ethylene oxide yezvisingabvirike zvekuvhiya sutures, uye hapana chinongedzo che2-chloroethanol.Sutures ine mukana wehuwandu hwemvura yemaindasitiri mukugadzira maitiro.Iwo mana mapoka emhando yemvura yemvura yedu yepasi anoshanda kune yakajairwa indasitiri yekudzivirira nzvimbo uye muviri wemunhu usiri wakananga kusangana nenzvimbo yemvura, kazhinji inobatwa nebleach, inogona kudzora algae uye tupukanana mumvura, inoshandiswa kusterilization uye hutsanana kudzivirira denda. .Chinhu chayo chikuru chinoshanda icalcium hypochlorite, iyo inogadzirwa nekupfuura chlorine gasi kuburikidza neraimu.Calcium hypochlorite inoderedzwa zviri nyore mumhepo, iyo huru yekuita formula ndeye: Ca(ClO)2+CO2+H2O–CaCO3+2HClO.hypochlorite inoora nyore nyore kuita hydrochloric acid uye mvura pasi pechiedza, iyo huru yekuita formula ndeye: 2HClO+light-2HCl+O2.2HCl + O2.Chlorine negative ions zviri nyore adsorbed mu sutures, uye pasi pemamwe mamiriro asina simba ane acidic kana alkaline, ethylene oxide inovhura mhete nayo kuti ibudise 2-chloroethanol.
Zvave zvichishumwa mumabhuku [8] kuti yakasara 2-chloroethanol paIOL samples yakatorwa ne ultrasonic extraction neacetone uye yakatemwa negasi chromatography-mass spectrometry, asi haina kuonekwa.YY0290.8-2008 “Ophthalmic Optics Artificial Lens Chikamu 8: Zvinodiwa Zvekutanga ”inotaura kuti yasara huwandu hwe2-chloroethanol paIOL haifanirwe kudarika 2.0µg pazuva palenzi, uye kuti huwandu hwese hwelenzi imwe neimwe haifanirwe kudarika 5.0 Iyo GB/T16886. 7-2015 yakajairika inotaura kuti iyo ocular toxicity inokonzerwa ne2-chloroethanol yakasara yakapetwa ka4 pane iyo inokonzerwa nechiyero chakafanana cheethylene oxide.
Muchidimbu, kana uchiongorora zvakasara zvemidziyo yekurapa mushure mekuita sterilization ne ethylene oxide, ethylene oxide uye 2-chloroethanol inofanira kutariswa, asi zvisaririra zvadzo zvinofanirwawo kuongororwa zvizere zvichienderana nemamiriro chaiwo.
Munguva yekuvharirwa kwemidziyo yekurapa, zvimwe zvezvishandiso zvekushandisa zvekurapa zvekushandisa kamwe chete kana zvekurongedza zvinhu zvinosanganisira polyvinyl chloride (PVC), uye shoma shoma yevinyl chloride monomer (VCM) ichagadzirwawo nekuparara kwePVC resin. panguva yekugadzirisa.GB10010-2009 pombi dzekurapa dzakapfava dzePVC dzinoratidza kuti zviri muVCM hazvigone kudarika 1µg.g-1.VCM iri nyore polymerized pasi pechiito che catalysts (peroxides, etc) kana chiedza uye kupisa kuburitsa polyvinyl chloride resin, pamwe chete inozivikanwa sevinyl chloride resin.Vinyl chloride iri nyore polymerized pasi pechiito checatalyst (peroxide, nezvimwewo) kana chiedza uye kupisa kuti ibudise polyvinyl chloride, pamwe chete inozivikanwa sevinyl chloride resin.Kana polyvinyl chloride ichipisa pamusoro pe100 ° C kana kuratidzwa nemwaranzi yeultraviolet, pane mukana wekuti hydrogen chloride gasi inogona kubuda.Ipapo musanganiswa wehydrogen chloride gasi uye ethylene oxide mukati mepakeji inoburitsa imwe huwandu hwe2-chloroethanol.
Ethylene glycol, yakagadzikana muzvisikwa, haina kushanduka.Atomu yeokisijeni iri muethylene oxide inotakura maviri maviri ega maerekitironi uye ine yakasimba hydrophilicity, izvo zvinoita kuti zvive nyore kugadzira ethylene glycol kana ichigara neiyo negative chloride ions.Somuenzaniso: C2H4O + NaCl + H2O – CH2Cl – CH2OH + NaOH.chiitiko ichi hachina kusimba pamagumo ekuita uye chakasimba pamagumo ekugadzirwa, uye chiitiko chekuita uku kwakaderera.Chiitiko chepamusoro ndechekuumbwa kwe ethylene glycol kubva ku ethylene oxide inosangana nemvura: C2H4O + H2O - CH2OH - CH2OH, uye hydration ye ethylene oxide inhibits kusunga kwayo kusunungura chlorine negative ions.
Kana chlorine negative ions ikaunzwa mukugadzirwa, sterilization, kuchengetedza, kutakura uye kushandiswa kwemidziyo yekurapa, pane mukana wekuti ethylene oxide ichaita pamwe navo kuita 2-chloroethanol.Sezvo nzira ye chlorohydrin yakabviswa kubva mukugadzira, chigadzirwa chayo chepakati, 2-chloroethanol, haizoitike munzira yakananga oxidation.Mukugadzirwa kwezvishandiso zvekurapa, zvimwe zvekushandisa zvine simba adsorption zvivakwa zve ethylene oxide uye 2-chloroethanol, saka kutonga kwemari yavo yasara kunofanirwa kutariswa pakuzviongorora mushure mekuita sterilization.Pamusoro pezvo, panguva yekugadzirwa kwemidziyo yekurapa, mbishi, zviwedzere, reaction inhibitors, nezvimwe zvine inorganic munyu muchimiro chekloridi, uye kana yakavharwa, mukana wekuti ethylene oxide inovhura mhete pasi peacidic kana alkaline mamiriro, inosangana neSN2. reaction, uye inosanganisa nemahara chlorine negative ions kugadzira 2-chloroethanol inofanirwa kutariswa.
Parizvino, iyo inowanzoshandiswa nzira yekuona ethylene oxide, 2-chloroethanol uye ethylene glycol ndiyo gasi chikamu nzira.Ethylene oxide inogonawo kuonekwa nenzira yecolorimetric uchishandisa pinched red sulfite test solution, asi chakashata ndechekuti chokwadi chemhedzisiro yebvunzo inokanganiswa nezvimwe zvinhu mumamiriro ekuyedzwa, sekuona tembiricha isingaperi ye37 ° C mumhepo. nharaunda yekuyedza kuitira kudzora maitiro ethylene glycol, uye nguva yekuisa mhinduro kuti iedzwe mushure mekuita kwemavara ekuvandudza.Nokudaro, kusimbiswa kwemaitiro (kusanganisira kurongeka, kurongeka, mutsara, kunzwa, nezvimwewo) murabhoritari inonyatsokodzera kukosha kwekuonekwa kwehuwandu hwezvisaririra.
III.Mafungiro ekuongorora maitiro
Ethylene oxide, 2-chloroethanol uye ethylene glycol zvisaririra zvakajairika mushure me ethylene oxide sterilization yemidziyo yekurapa.Kuita zvakasara kuongororwa, kuiswa kwezvinhu zvakakodzera mukugadzirwa uye kuchengetedza ethylene oxide, kugadzirwa uye sterilization yemidziyo yekurapa inofanirwa kutariswa.
Pane dzimwe nyaya mbiri dzinofanirwa kutariswa pabasa chairo rekuongorora mudziyo wekurapa: 1. Zvingave zvakakosha kuita ongororo yezvisaririra zve2-chloroethanol.Mukugadzirwa kwe ethylene oxide, kana iyo yechinyakare chlorohydrin nzira yakashandiswa, kunyangwe kucheneswa, kusefa uye dzimwe nzira dzichagamuchirwa mukugadzira, ethylene oxide gasi ichange iine yepakati chigadzirwa 2-chloroethanol kusvika pamwero wakati, uye huwandu hwayo hwasara. inofanira kuongororwa.Kana iyo oxidation nzira yakashandiswa, hapana sumo ye2-chloroethanol, asi yakasara yakawanda yeakakodzera inhibitors, catalysts, nezvimwewo mu ethylene oxide reaction process inofanirwa kutariswa.Zvishandiso zvekurapa zvinoshandisa huwandu hwakakura hwemvura yeindasitiri mukugadzira, uye imwe huwandu hwehypochlorite uye chlorine negative ions zvakare yakashambadzirwa mune yakapedzwa chigadzirwa, izvo zvikonzero zvekugona kuvepo kwe2-chloroethanol mune yakasara.Panewo zviitiko zvekuti iyo mbishi uye kurongedza kwemidziyo yekurapa inorganic munyu ine elemental chlorine kana polymer zvinhu zvine chimiro chakatsiga uye hazvisi nyore kutyora chisungo, etc. Naizvozvo, zvakakosha kuongorora zvizere kana njodzi ye2-chloroethanol. zvakasara zvinofanirwa kuongororwa kuti zviongororwe, uye kana paine humbowo hwakakwana hunoratidza kuti haizopinzwa mu2-chloroethanol kana kuti yakaderera pane yekuona muganhu wenzira yekuona, bvunzo inogona kuregererwa kudzora njodzi yayo.2. Nokuda kwe ethylene glycol Analytical evaluation yemasara.Kuenzaniswa ne ethylene oxide uye 2-chloroethanol, iyo yekubata toxicity ye ethylene glycol residues yakaderera, asi nekuti ethylene oxide kugadzirwa uye kushandiswa kuchaiswawo pachena kucarbon dioxide nemvura, uye ethylene oxide nemvura zviri nyore kugadzira ethylene glycol, uye ethylene glycol mushure mekuita sterilization inoenderana nekuchena kwe ethylene oxide, uye zvakare ine chekuita nekurongedza, kunyorova kwehutachiona, uye tembiricha uye hunyoro nharaunda ye sterilization, saka, ethylene glycol inofanirwa kutariswa zvinoenderana nemamiriro chaiwo. .Evaluation.
Miyero ndeimwe yezvishandiso zvekuongorora tekinoroji yemidziyo yekurapa, iyo tekinoroji ongororo yemidziyo yekurapa inofanirwa kutarisa kune zvakakosha zvinodiwa zvekuchengetedza uye kushanda kwekugadzirwa kwechigadzirwa nekusimudzira, kugadzira, kuchengetedza, kushandiswa uye zvimwe zvikamu zvekuongorora kwakadzama kwezvinhu zvinokanganisa. kuchengetedzeka uye kushanda kweiyo dzidziso uye maitiro, zvichibva pasainzi, zvichibva pane chokwadi, pane kutaura zvakananga kune mwero, wakavharwa kubva kumamiriro chaiwo ekugadzirwa kwechigadzirwa, kutsvagisa nekusimudzira, kugadzira uye kushandiswa.Basa rekuongorora rinofanirwa kubhadhara zvakanyanya kune yekurapa mudziyo wekugadzirwa kwemhando system yekutonga kweakakodzera zvinongedzo, panguva imwechete pa-saiti ongororo inofanirawo kuve "dambudziko" rakanangana, kupa kutamba kwakazara kune basa re "maziso" kune. kuvandudza kunaka kwekuongorora, chinangwa chekuongorora kwesayenzi.
Kwakabva: Center for Technical Ongororo yeMedical Devices, State Drug Administration (SDA)
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Nguva yekutumira: Sep-21-2023