I. Semelo
Ka kakaretso, lisebelisoa tsa bongaka tse silafalitsoeng ka ethylene oxide li lokela ho hlahlojoa le ho hlahlojoa bakeng sa masala a post-sterilization, kaha palo ea masala e amana haufi-ufi le bophelo bo botle ba ba pepesehetseng sesebelisoa sa bongaka.Ethylene oxide ke ntho e ka sehloohong e senyang tsamaiso ea methapo.Haeba ho kopane le letlalo, bofubelu le ho ruruha ho etsahala ka potlako, ho phatloha ho etsahala ka mor'a lihora tse 'maloa,' me ho kopana khafetsa ho ka etsa hore motho a be le maikutlo.Ho fafatsa mokelikeli mahlong ho ka baka cheso ea cornea.Tabeng ea ho pepeseha ha nako e telele ho tse nyane, lefu la neurasthenia le mathata a methapo ea limela li ka bonoa.Ho tlalehiloe hore oral oral LD50 ka likhoto ke 330 mg/Kg, le hore ethylene oxide e ka eketsa sekhahla sa ho kheloha ha li-chromosome tsa moko oa litoeba [1].Likhahla tse phahameng tsa kankere le lefu li tlalehiloe ho basebetsi ba pepesehetseng ethylene oxide.[2] 2-Chloroethanol e ka baka erythema ea letlalo haeba e kopane le letlalo;e ka monngoa ka ho toba ho baka chefo.Ho ja ka molomo ho ka bolaea.Ho pepeseha ha nako e telele ka nako e telele ho ka baka tšenyo tsamaisong ea methapo e bohareng, tsamaiso ea pelo le matšoafo.Liphetho tsa lipatlisiso tsa malapeng le tsa kantle ho ethylene glycol lia lumela hore chefo ea eona e tlase.Ts'ebetso ea eona ea metabolism 'meleng e tšoana le ea ethanol, ka metabolism ea ethanol dehydrogenase le acetaldehyde dehydrogenase, lihlahisoa tsa mantlha ke glyoxalic acid, oxalic acid le lactic acid, tse nang le chefo e phahameng.Ka hona, litekanyetso tse 'maloa li na le litlhoko tse khethehileng bakeng sa masala ka mor'a ho sterilization ka ethylene oxide.Mohlala, GB/T 16886.7-2015 "Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residues", YY0290.8-2008 "Ophthalmic Optics Artificial Lens Karolo ea 8: Litlhoko tsa Motheo", le litekanyetso tse ling li na le litlhokahalo tse qaqileng ea masala a ethylene oxide le 2-chloroethanol.GB/T 16886.7-2015 e bolela ka ho hlaka hore ha u sebelisa GB/T 16886.7-2015, ho boleloa ka ho hlaka hore ha 2-chloroethanol e le teng ka lisebelisoa tsa bongaka tse sterilized ke ethylene oxide, residue ea eona e phahameng e lumelloang. e boetse e haelloa ka ho hlaka.Ka hona, hoa hlokahala ho sekaseka ka botlalo tlhahiso ea masala a tloaelehileng (ethylene oxide, 2-chloroethanol, ethylene glycol) ho tsoa tlhahiso, lipalangoang le polokelo ea ethylene oxide, tlhahiso ea lisebelisoa tsa bongaka le ts'ebetso ea sterilization.
II.Tlhahlobo ea masala a sterilization
Ts'ebetso ea tlhahiso ea ethylene oxide e arotsoe ka mokhoa oa chlorohydrin le mokhoa oa oxidation.Har'a bona, mokhoa oa chlorohydrin ke mokhoa oa pele oa tlhahiso ea ethylene oxide.Haholo-holo e na le mekhoa e 'meli ea ho itšoara: mohato oa pele: C2H4 + HClO - CH2Cl - CH2OH;mohato oa bobeli: CH2Cl – CH2OH + CaOH2 – C2H4O + CaCl2 + H2O.mokhoa oa eona oa ho itšoara Sehlahisoa sa mahareng ke 2-chloroethanol (CH2Cl-CH2OH).Ka lebaka la theknoloji ea morao-rao ea mokhoa oa chlorohydrin, tšilafalo e tebileng ea tikoloho, hammoho le sehlahisoa sa ho bola ho hoholo ha lisebelisoa, bahlahisi ba bangata ba felisitsoe [4].Mokhoa oa oxidation [3] o arotsoe ka mekhoa ea moea le ea oksijene.Ho ea ka bohloeki bo fapaneng ba oksijene, tlhahiso ea mantlha e na le mekhoa e 'meli ea ho itšoara: mohato oa pele: 2C2H4 + O2 - 2C2H4O;mohato oa bobeli: C2H4 + 3O2 - 2CO2 + H2O.hajoale, tlhahiso ea indasteri ea ethylene oxide Hajoale, tlhahiso ea indasteri ea ethylene oxide e amohela haholo ts'ebetso ea oxidation e tobileng ea ethylene ka silevera e le sesosa.Ka hona, ts'ebetso ea tlhahiso ea ethylene oxide ke ntho e etsang qeto ea tlhahlobo ea 2-chloroethanol ka mor'a hore ho be le sterilization.
Ha a bua ka litokisetso tse amehang ho GB/T 16886.7-2015 standard ho phethahatsa netefatso le nts'etsopele ea ts'ebetso ea ethylene oxide sterilization, ho ea ka thepa ea physicochemical ea ethylene oxide, masala a mangata a teng ka mokhoa oa pele ka mor'a hore ho be le sterilization.Lintho tse amang palo ea masala haholo-holo li kenyelletsa ho kenngoa ha ethylene oxide ka lisebelisoa tsa bongaka, thepa ea ho paka le botenya, mocheso le mongobo pele le ka morao ho sterilization, nako ea ts'ebetso ea sterilization le nako ea tharollo, maemo a polokelo, joalo-joalo, 'me lintlha tse ka holimo li khetholla ho baleha. bokhoni ba ethylene oxide.Ho 'nile ha tlalehoa libukeng [5] hore mahloriso a ethylene oxide sterilization hangata a khethoa e le 300-1000mg.L-1.Lintho tse lahleheloang ke ethylene oxide nakong ea sterilization haholo-holo li kenyelletsa: adsorption ea lisebelisoa tsa bongaka, hydrolysis tlas'a maemo a itseng a mongobo, joalo-joalo.Motsoako oa 500-600mg.L-1 o batla o le moruo ebile o sebetsa hantle, o fokotsa tšebeliso ea ethylene oxide le masala holim'a lintho tse sterilized, ho boloka litšenyehelo tsa sterilization.
Chlorine e na le mefuta e mengata ea lisebelisoa indastering ea lik'hemik'hale, lihlahisoa tse ngata li amana haufi-ufi le rona.E ka sebelisoa e le ea mahareng, joalo ka vinyl chloride, kapa joalo ka sehlahisoa sa ho qetela, joalo ka bleach.Ka nako e ts'oanang, chlorine e boetse e teng moeeng, metsing le libakeng tse ling, kotsi ea 'mele oa motho e boetse e totobetse.Ka hona, ha lisebelisoa tsa bongaka tse amehang li silafatsoa ke ethylene oxide, tlhahlobo e felletseng ea tlhahiso, sterilization, polokelo le likarolo tse ling tsa sehlahisoa li lokela ho nahanoa, 'me mehato e lebisitsoeng e lokela ho nkuoa ho laola palo e setseng ea 2-chloroethanol.
Lingoliloeng li tlalehile hore litaba tsa 2-chloroethanol li fihlile hoo e ka bang 150 µg / piece ka mor'a lihora tse 72 tsa tharollo ea patch ea band-aid e hloekisitsoeng ke ethylene oxide, le mabapi le lisebelisoa tsa nako e khuts'oane tse boletsoeng. ka tekanyo ea GB/T16886.7-2015, tekanyo ea letsatsi le letsatsi ea 2-chloroethanol ho mokuli ha ea lokela ho ba ho feta 9 mg, 'me palo ea eona e setseng e tlase haholo ho feta tekanyo ea tekanyo e tloaelehileng.
Phuputso [7] e ile ea lekanya masala a ethylene oxide le 2-chloroethanol ka mefuta e meraro ea likhoele tsa suture, 'me liphetho tsa ethylene oxide li ne li sa bonahale 'me 2-chloroethanol e ne e le 53.7 µg.g-1 bakeng sa khoele ea suture e nang le khoele ea nylon. .YY 0167-2005 e fana ka moeli oa ho fumanoa bakeng sa ethylene oxide bakeng sa li-sutures tse sa khoneng ho buoa, 'me ha ho na stipulation bakeng sa 2-chloroethanol.Li-sutures li na le monyetla oa ho ba le metsi a mangata a indasteri nakong ea tlhahiso.Likarolo tse 'ne tsa boleng ba metsi a rona a fatše li sebetsa sebakeng se akaretsang sa ts'ireletso ea indasteri le' mele oa motho o sa kopane ka kotloloho le sebaka sa metsi, ka kakaretso se tšoaroang ka bleach, se khona ho laola algae le likokoana-hloko tse ka metsing, tse sebelisetsoang sterilization le ho thibela seoa sa bohloeki. .Motsoako oa eona o ka sehloohong o sebetsang ke calcium hypochlorite, e hlahisoang ke ho fetisa khase ea chlorine ka har'a lejoe la mokoetla.Calcium hypochlorite e senyeha habonolo moeeng, mokhoa o ka sehloohong oa karabelo ke: Ca(ClO)2+CO2+H2O–CaCO3+2HClO.hypochlorite e senyeha habonolo hore e be hydrochloric acid le metsi tlas'a leseli, mokhoa o ka sehloohong oa ho arabela ke: 2HClO+light-2HCl+O2.2HCl + O2. Li-ion tse mpe tsa chlorine li adsorbed habonolo ka li-sutures, 'me tlas'a maemo a itseng a fokolang a acidic kapa alkaline, ethylene oxide e bula lesale ka eona ho hlahisa 2-chloroethanol.
Ho tlalehiloe libukeng [8] hore masala a 2-chloroethanol ho lisampole tsa IOL e ile ea ntšoa ka ho ntšoa ha ultrasonic ka acetone mme ea khethoa ke khase ea chromatography-mass spectrometry, empa ha ea ka ea fumanoa.YY0290.8-2008 “Ophthalmic Optics Artificial Lense Karolo ea 8: Litlhoko tsa Motheo” e bolela hore palo e setseng ea 2-chloroethanol ho IOL ha ea lokela ho feta 2.0µg ka letsatsi ka lense, le hore kakaretso ea lense ka 'ngoe ha ea lokela ho feta 5.0 The GB/T16886. 7-2015 standard e bolela hore chefo ea mahlo e bakoang ke masala a 2-chloroethanol e phahame ka makhetlo a 4 ho feta a bakoang ke boemo bo tšoanang ba ethylene oxide.
Ka kakaretso, ha ho hlahlojoa masala a lisebelisoa tsa bongaka ka mor'a hore ho be le sterilization ka ethylene oxide, ethylene oxide le 2-chloroethanol li lokela ho lebisoa ho tsona, empa masala a tsona a boetse a lokela ho hlahlojoa ka botlalo ho ea ka boemo ba sebele.
Nakong ea ho hloekisoa ha lisebelisoa tsa bongaka, lisebelisoa tse ling tsa lisebelisoa tsa bongaka tse sebelisoang hang-hang kapa thepa ea ho paka li kenyelletsa polyvinyl chloride (PVC), le palo e nyane haholo ea vinyl chloride monomer (VCM) le eona e tla hlahisoa ke ho bola ha resin ea PVC. nakong ea ts'ebetso.GB10010-2009 liphaephe tsa bongaka tse bonolo tsa PVC li bolela hore litaba tsa VCM li ke ke tsa feta 1µg.g-1.VCM e entsoe ka polymerized habonolo tlas'a ts'ebetso ea li-catalysts (peroxides, joalo-joalo) kapa khanya le mocheso ho hlahisa resin ea polyvinyl chloride, e tsejoang ka hore ke vinyl chloride resin.Vinyl chloride e polymerized habonolo tlas'a ts'ebetso ea catalyst (peroxide, joalo-joalo) kapa khanya le mocheso ho hlahisa polyvinyl chloride, hammoho e tsejoang e le vinyl chloride resin.Ha polyvinyl chloride e futhumatsoa ka holimo ho 100 ° C kapa e pepesehetse mahlaseli a ultraviolet, ho na le monyetla oa hore khase ea hydrogen chloride e ka baleha.Ebe motsoako oa khase ea hydrogen chloride le ethylene oxide ka har'a sephutheloana o tla hlahisa palo e itseng ea 2-chloroethanol.
Ethylene glycol, e tsitsitseng ka tlhaho, ha e fetohe.Athomo ea oksijene e ethylene oxide e na le lipara tse peli tsa elektronike 'me e na le hydrophilicity e matla, e etsang hore ho be bonolo ho hlahisa ethylene glycol ha e kopana le li-ion tse mpe tsa chloride.Mohlala: C2H4O + NaCl + H2O – CH2Cl – CH2OH + NaOH.ts'ebetso ena e fokola ka mokhoa o fokolang qetellong ea ts'ebetso 'me e matla haholo qetellong ea tlhahiso,' me ketsahalo ea karabelo ena e tlaase.Ketsahalo e phahameng ke ho thehoa ha ethylene glycol ho tloha ethylene oxide ho kopana le metsi: C2H4O + H2O - CH2OH - CH2OH, 'me hydration ea ethylene oxide e thibela ho tlama ha eona ho lokolla li-ion tse mpe tsa chlorine.
Haeba li-ion tse mpe tsa chlorine li hlahisoa tlhahiso, sterilization, polokelo, lipalangoang le ts'ebeliso ea lisebelisoa tsa bongaka, ho na le monyetla oa hore ethylene oxide e tla itšoara le bona ho theha 2-chloroethanol.Kaha mokhoa oa chlorohydrin o felisitsoe ts'ebetsong ea tlhahiso, sehlahisoa sa eona sa bohareng, 2-chloroethanol, se ke ke sa etsahala ka mokhoa o tobileng oa oxidation.Tlhahisong ea lisebelisoa tsa bongaka, lisebelisoa tse ling tse tala li na le thepa e matla ea adsorption bakeng sa ethylene oxide le 2-chloroethanol, ka hona, ho tlameha ho nahanoa ka taolo ea likhakanyo tsa tsona tse setseng ha ho li hlahlobisisoa ka mor'a ho etsa sterilization.Ho phaella moo, nakong ea tlhahiso ea lisebelisoa tsa bongaka, lisebelisoa tse tala, li-additives, li-inhibitors tsa ho arabela, joalo-joalo li na le letsoai la inorganic ka mokhoa oa chloride, 'me ha ho etsoa sterilized, monyetla oa hore ethylene oxide e bule selikalikoe tlas'a maemo a acidic kapa alkaline, e feta SN2. karabelo, 'me e kopana le li-ion tse mpe tsa chlorine ho hlahisa 2-chloroethanol e tlameha ho nahanoa.
Hona joale, mokhoa o tloaelehileng oa ho lemoha ethylene oxide, 2-chloroethanol le ethylene glycol ke mokhoa oa khase ea khase.Ethylene oxide e ka boela ea bonoa ka mokhoa oa colorimetric o sebelisa tharollo ea tlhahlobo e khubelu ea sulfite, empa bobe ba eona ke hore bonnete ba liphetho tsa liteko bo angoa ke lintlha tse ngata maemong a liteko, joalo ka ho netefatsa mocheso o sa feleng oa 37 ° C sebakeng sa heno. tikoloho ea liteko e le ho laola karabelo ea ethylene glycol, le nako ea ho beha tharollo ho lekoa kamora ts'ebetso ea nts'etsopele ea mebala.Ka hona, netefatso ea mokhoa o tiisitsoeng (ho kenyeletsoa ho nepahala, ho nepahala, ho lekana, kutloisiso, joalo-joalo) ka laboratoring e tšoanelehang ke ea bohlokoa ba litšupiso bakeng sa ho fumanoa ha palo ea masalla.
III.Maikutlo mabapi le ts'ebetso ea tlhahlobo
Ethylene oxide, 2-chloroethanol le ethylene glycol ke masala a tloaelehileng ka mor'a hore ethylene oxide sterilization ea lisebelisoa tsa bongaka.Ho etsa tlhahlobo ea masala, ho kenyelletsoa ha lintho tse amehang tlhahiso le polokelo ea ethylene oxide, tlhahiso le sterilization ea lisebelisoa tsa bongaka li lokela ho nahanoa.
Ho na le lintlha tse ling tse peli tse lokelang ho tsepamisoa mosebetsing oa sebele oa tlhahlobo ea lisebelisoa tsa bongaka: 1. Hore na hoa hlokahala ho etsa tlhahlobo ea masala a 2-chloroethanol.Ha ho etsoa ethylene oxide, haeba mokhoa oa setso oa chlorohydrin o sebelisoa, leha ho hloekisoa, ho sefa le mekhoa e meng e tla amoheloa molemong oa tlhahiso, khase ea ethylene oxide e ntse e na le sehlahisoa sa mahareng sa 2-chloroethanol ho isa tekanyong e itseng, le palo ea eona e setseng. e lokela ho hlahlojwa.Haeba mokhoa oa oxidation o sebelisoa, ha ho na kenyelletso ea 2-chloroethanol, empa palo e setseng ea li-inhibitors tse amehang, li-catalysts, joalo-joalo ts'ebetsong ea ethylene oxide reaction e lokela ho nkoa.Lisebelisoa tsa bongaka li sebelisa metsi a mangata mosebetsing oa tlhahiso, 'me palo e itseng ea hypochlorite le li-ion tse mpe tsa chlorine li boetse li adsorbed ka sehlahisoa se felileng, e leng mabaka a ho ba teng ha 2-chloroethanol ka masala.Hape ho na le maemo a hore lisebelisoa tse tala le ho paka lisebelisoa tsa bongaka ke matsoai a inorganic a nang le elemental chlorine kapa lisebelisoa tsa polymer tse nang le sebopeho se tsitsitseng 'me ha ho bonolo ho senya tlamo, joalo-joalo. masala a tlameha ho lekoa bakeng sa tlhahlobo, 'me haeba ho na le bopaki bo lekaneng ba ho bontša hore e ke ke ea kenngoa ho 2-chloroethanol kapa e ka tlaase ho moeli oa ho lemoha mokhoa oa ho lemoha, tlhahlobo e ka hlokomolohuoa ho laola kotsi ea eona.2. Bakeng sa tlhahlobo ea ethylene glycol Analytical ea masala.Ha ho bapisoa le ethylene oxide le 2-chloroethanol, chefo ea ho kopana le masala a ethylene glycol e tlase, empa hobane tlhahiso le tšebeliso ea ethylene oxide le tsona li tla pepesetsoa carbon dioxide le metsi, 'me ethylene oxide le metsi li tloaetse ho hlahisa ethylene glycol, dikahare tsa ethylene glycol ka mor'a sterilization e amana le bohloeki ba ethylene oxide, hape e amana le ho paka, mongobo oa likokoana-hloko, le mocheso le mongobo oa tikoloho ea sterilization, ka hona, ethylene glycol e lokela ho nkoa ho latela maemo a sebele. .Tlhahlobo.
Litekanyetso ke e 'ngoe ea lisebelisoa tsa tlhahlobo ea tekheniki ea lisebelisoa tsa bongaka, tlhahlobo ea tekheniki ea lisebelisoa tsa bongaka e lokela ho tsepamisa maikutlo ho litlhoko tsa mantlha tsa polokeho le katleho ea moralo oa sehlahisoa le nts'etsopele, tlhahiso, polokelo, ts'ebeliso le likarolo tse ling tsa tlhahlobo e felletseng ea lintlha tse amang. tšireletseho le katleho ea khopolo le ts'ebetso, e thehiloeng ho saense, e thehiloeng holim'a lintlha, ho e-na le ho bua ka ho toba ho maemo, a arohaneng le boemo ba sebele ba moralo oa sehlahisoa, lipatlisiso le nts'etsopele, tlhahiso le tšebeliso.Mosebetsi oa ho hlahloba o lokela ho ela hloko haholoanyane tsamaiso ea boleng ba tlhahiso ea lisebelisoa tsa bongaka bakeng sa taolo ea li-link tse amehang, ka nako e ts'oanang tlhahlobo ea setšeng e boetse e lokela ho ba "bothata", e fane ka papali e feletseng ho karolo ea "mahlo" ho. ntlafatsa boleng ba tlhahlobo, sepheo sa tlhahlobo ea mahlale.
Mohloli: Setsi sa Tlhahlobo ea Tekheniki ea Lisebelisoa tsa Bongaka, Tsamaiso ea Lithethefatsi ea Naha (SDA)
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Nako ea poso: Sep-21-2023