I. Mbiri
Nthawi zambiri, zida zachipatala zotsekedwa ndi ethylene oxide ziyenera kufufuzidwa ndikuwunikiridwa kuti zikhale zotsalira pambuyo pa sterilization, chifukwa kuchuluka kwa zotsalirazo kumagwirizana kwambiri ndi thanzi la anthu omwe ali ndi chipangizo chachipatala.Ethylene oxide ndi gawo lapakati lamanjenje lomwe limasokoneza.Ngati kukhudzana ndi khungu, redness ndi kutupa zimachitika mofulumira, matuza kumachitika patapita maola angapo, ndipo mobwerezabwereza kukhudzana kungayambitse tcheru.Kuwaza madzi m'maso kumatha kuyambitsa zilonda zam'maso.Pakakhala nthawi yayitali yocheperako, matenda a neurasthenia ndi matenda a mitsempha ya vegetative amatha kuwoneka.Zanenedwa kuti pachimake pakamwa LD50 mu makoswe ndi 330 mg/Kg, komanso kuti ethylene oxide imatha kukulitsa kuchuluka kwa ma chromosome a m'mafupa mu mbewa [1].Kuchuluka kwa carcinogenicity ndi kufa kwanenedwa kwa ogwira ntchito omwe ali ndi ethylene oxide.[2] 2-Chloroethanol ikhoza kuyambitsa erythema ya pakhungu ngati ikukhudzana ndi khungu;imatha kuyamwa mwachisawawa kuti ipangitse chiphe.Kudya m'kamwa kumatha kupha.Kuwonekera kwanthawi yayitali kumatha kuwononga dongosolo lapakati lamanjenje, dongosolo lamtima ndi mapapo.Zotsatira za kafukufuku wapakhomo ndi wakunja pa ethylene glycol amavomereza kuti kawopsedwe kake ndi kochepa.Kagayidwe kake m'thupi ndi chimodzimodzi ndi ethanol, kudzera mu kagayidwe ka ethanol dehydrogenase ndi acetaldehyde dehydrogenase, zinthu zazikulu ndi glyoxalic acid, oxalic acid ndi lactic acid, zomwe zimakhala ndi kawopsedwe wapamwamba.Chifukwa chake, milingo ingapo imakhala ndi zofunikira zenizeni zotsalira pambuyo poyezetsa ndi ethylene oxide.Mwachitsanzo, GB/T 16886.7-2015 "Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residues", YY0290.8-2008 "Ophthalmic Optics Artificial Lens Part 8: Basic Requirements", ndi malire ena ali ndi zofunikira zatsatanetsatane za zotsalira za ethylene okusayidi ndi 2-chloroethanol.GB/T 16886.7-2015 momveka bwino kuti pamene ntchito GB/T 16886.7-2015, momveka bwino kuti pamene 2-chloroethanol alipo mu zipangizo zachipatala chosawilitsidwa ndi ethylene okusayidi, pazipita zake zotsalira zovomerezeka. imakhalanso ndi malire.Chifukwa chake, ndikofunikira kusanthula mwatsatanetsatane kupanga zotsalira wamba (ethylene oxide, 2-chloroethanol, ethylene glycol) kuchokera pakupanga, kunyamula ndi kusungirako ethylene oxide, kupanga zida zamankhwala, komanso njira yotseketsa.
II.Kuwunika kwa zotsalira zotsalira
Njira yopanga ethylene oxide imagawidwa mu njira ya chlorohydrin ndi njira ya okosijeni.Mwa iwo, njira ya chlorohydrin ndi njira yoyambilira yopanga ethylene oxide.Zimakhala ndi njira ziwiri zomwe zimachitika: sitepe yoyamba: C2H4 + HClO - CH2Cl - CH2OH;sitepe yachiwiri: CH2Cl – CH2OH + CaOH2 – C2H4O + CaCl2 + H2O.momwe zimachitikira The wapakatikati mankhwala ndi 2-chloroethanol (CH2Cl-CH2OH).Chifukwa chaukadaulo wakumbuyo wa njira ya chlorohydrin, kuyipitsa kwakukulu kwa chilengedwe, komanso kupangidwa kwa zida zowonongeka kwambiri, opanga ambiri achotsedwa [4].Njira ya okosijeni [3] imagawidwa mu njira za mpweya ndi mpweya.Malinga ndi chiyero chosiyana cha okosijeni, kupanga kwakukulu kumakhala ndi njira ziwiri zomwe zimachitika: sitepe yoyamba: 2C2H4 + O2 - 2C2H4O;sitepe yachiwiri: C2H4 + 3O2 – 2CO2 + H2O.pakali pano, kupanga mafakitale a ethylene okusayidi Panopa, kupanga mafakitale wa ethylene okusayidi makamaka utenga ethylene mwachindunji makutidwe ndi okosijeni ndondomeko ndi siliva monga chothandizira.Choncho, kupanga ethylene oxide ndi chinthu chomwe chimatsimikizira kuwunika kwa 2-chloroethanol pambuyo potseketsa.
Ponena za makonzedwe oyenera mu GB/T 16886.7-2015 muyezo kuchita chitsimikiziro ndi chitukuko cha ethylene okusayidi njira yolera yotseketsa, malinga ndi physicochemical katundu wa ethylene okusayidi, zambiri zotsalira zilipo mu mawonekedwe oyambirira pambuyo yolera yotseketsa.Zomwe zimakhudza kuchuluka kwa zotsalira makamaka zimaphatikizapo kutengeka kwa ethylene oxide ndi zida zamankhwala, zonyamula katundu ndi makulidwe, kutentha ndi chinyezi musanayambe kapena pambuyo potsekereza, nthawi yoletsa kutsekereza ndi nthawi yothetsera, kusungirako, ndi zina zambiri. luso la ethylene oxide.Zanenedwa m'mabuku [5] kuti kuchuluka kwa ethylene oxide sterilization nthawi zambiri kumasankhidwa ngati 300-1000mg.L-1.Zomwe zimatayika za ethylene oxide panthawi yotseketsa makamaka zimaphatikizapo: kutsatsa kwa zida zamankhwala, hydrolysis pansi pa chinyezi china, ndi zina zotero.Kuchuluka kwa 500-600mg.L-1 kumakhala kopanda ndalama komanso kothandiza, kuchepetsa kumwa kwa ethylene oxide ndi zotsalira pa zinthu zosawilitsidwa, kupulumutsa mtengo wotseketsa.
Chlorine ili ndi ntchito zambiri m'makampani opanga mankhwala, zinthu zambiri zimagwirizana kwambiri ndi ife.Itha kugwiritsidwa ntchito ngati yapakatikati, monga vinyl chloride, kapena ngati chomaliza, monga bleach.Panthawi imodzimodziyo, chlorine imakhalanso mumlengalenga, madzi ndi malo ena, kuvulaza thupi la munthu kumaonekeranso.Choncho, pamene zipangizo zachipatala zoyenera zimatsukidwa ndi ethylene oxide, kusanthula kwathunthu kwa kupanga, kutseketsa, kusungirako ndi zina za mankhwala kuyenera kuganiziridwa, ndipo njira zomwe zimayang'aniridwa ziyenera kuchitidwa kuti zithetse kuchuluka kwa 2-chloroethanol.
Zanenedwa m'mabuku [6] kuti zomwe zili mu 2-chloroethanol zidafika pafupifupi 150 µg/chidutswa pambuyo pa maola 72 akusintha kwa band-aid chigamba chotsukidwa ndi ethylene oxide, komanso potengera zida zolumikizana kwakanthawi kochepa. muyezo wa GB/T16886.7-2015, pafupifupi tsiku lililonse mlingo wa 2-chloroethanol kwa wodwala sayenera kupitirira 9 mg, ndipo kuchuluka kwake kotsalira kumakhala kotsika kwambiri kuposa malire a muyezo.
Kafukufuku [7] anayeza zotsalira za ethylene oxide ndi 2-chloroethanol mu mitundu itatu ya ulusi wa suture, ndipo zotsatira za ethylene oxide zinali zosaoneka ndipo 2-chloroethanol inali 53.7 µg.g-1 ya ulusi wa suture wokhala ndi ulusi wa nayiloni. .YY 0167-2005 imafotokoza malire ozindikira ethylene oxide pa ma suture osayamwa opangira opaleshoni, ndipo palibe lamulo la 2-chloroethanol.Ma sutures ali ndi mwayi wokhala ndi madzi ambiri a mafakitale popanga.Magulu anayi amadzi amadzi athu apansi akugwiritsidwa ntchito kudera lachitetezo cha mafakitale komanso thupi lamunthu losagwirizana ndi madzi, lomwe limagwiritsidwa ntchito ndi bleach, limatha kuwongolera algae ndi tizilombo tating'onoting'ono m'madzi, zomwe zimagwiritsidwa ntchito poletsa komanso kupewa ukhondo wamiliri. .Chomwe chimagwiritsidwa ntchito kwambiri ndi calcium hypochlorite, yomwe imapangidwa podutsa mpweya wa chlorine kudzera mwa miyala yamchere.Calcium hypochlorite imawonongeka mosavuta mumlengalenga, njira yayikulu yochitira ndi: Ca(ClO)2+CO2+H2O–CaCO3+2HClO.Hypochlorite imawola mosavuta kukhala hydrochloric acid ndi madzi pansi pa kuwala, njira yayikulu yochitira ndi: 2HClO+light—2HCl+O2.2HCl + O2. Chlorine negative ions amadsorbed mosavuta mu sutures, ndipo pansi pa malo ena ofooka acidic kapena alkaline, ethylene oxide imatsegula mpheteyo kuti ipange 2-chloroethanol.
Zanenedwa m'mabuku [8] kuti otsalira 2-chloroethanol pa IOL zitsanzo anatengedwa ndi akupanga m'zigawo ndi acetone ndipo anatsimikiza ndi mpweya chromatography-misa spectrometry, koma sanapezeke.YY0290.8-2008 “Ophthalmic Optics Artificial Lens Part 8: Basic Requirements” imati kuchuluka kotsalira kwa 2-chloroethanol pa IOL sikuyenera kupitilira 2.0µg patsiku pa lens, komanso kuti kuchuluka kwa mandala aliwonse zisapitirire 5.0 The GB/T16886. 7-2015 muyezo umatchula kuti ocular kawopsedwe chifukwa 2-chloroethanol zotsalira ndi 4 nthawi apamwamba kuposa amene amayamba ndi mlingo womwewo wa okusayidi ethylene.
Mwachidule, powunika zotsalira za zida zamankhwala pambuyo poyezetsa ndi ethylene oxide, ethylene oxide ndi 2-chloroethanol ziyenera kuyang'ana, koma zotsalira zawo ziyenera kufufuzidwanso mozama malinga ndi momwe zilili.
Pakutsekereza kwa zida zamankhwala, zida zina zopangira zida zamankhwala zogwiritsidwa ntchito kamodzi kapena zonyamula zimaphatikizirapo polyvinyl chloride (PVC), komanso kachulukidwe kakang'ono ka vinyl chloride monomer (VCM) kudzapangidwanso ndi kuwonongeka kwa utomoni wa PVC. pa processing.GB10010-2009 mapaipi ofewa azachipatala a PVC amati zomwe zili mu VCM sizingadutse 1µg.g-1.VCM mosavuta polymerized pansi zochita za catalysts (peroxides, etc) kapena kuwala ndi kutentha kutulutsa polyvinyl kolorayidi utomoni, pamodzi amadziwika kuti vinilu kolorayidi utomoni.Vinyl kolorayidi mosavuta polymerized pansi zochita za chothandizira (peroxide, etc.) kapena kuwala ndi kutentha kutulutsa polyvinyl kolorayidi, pamodzi zimadziwika kuti vinyl kolorayidi utomoni.Polyvinyl chloride ikatenthedwa kuposa 100 ° C kapena ikakumana ndi cheza cha ultraviolet, pali kuthekera kuti mpweya wa hydrogen chloride ungatuluke.Ndiye kuphatikiza wa haidrojeni kolorayidi mpweya ndi ethylene okusayidi mkati mwa phukusi kupanga kuchuluka kwa 2-chloroethanol.
Ethylene glycol, yokhazikika mwachilengedwe, sichitha.Atomu ya okosijeni mu ethylene oxide imanyamula ma elekitironi awiri okha ndipo imakhala ndi mphamvu ya hydrophilicity, zomwe zimapangitsa kuti zikhale zosavuta kupanga ethylene glycol mukakhala ndi ma ion chloride olakwika.Mwachitsanzo: C2H4O + NaCl + H2O – CH2Cl – CH2OH + NaOH.ndondomekoyi ndi ofooka m'munsi pa zotakasuka mapeto ndi mwamphamvu zofunika pa generative mapeto, ndi zochitika za anachita otsika.Chochitika chapamwamba ndi mapangidwe a ethylene glycol kuchokera ku ethylene oxide pokhudzana ndi madzi: C2H4O + H2O - CH2OH - CH2OH, ndipo hydration ya ethylene oxide imalepheretsa kumanga kwake kwa chlorine zoipa ions.
Ngati ayoni a klorini amayambitsidwa popanga, kutsekereza, kusungirako, kunyamula ndi kugwiritsa ntchito zida zamankhwala, pali kuthekera kuti ethylene oxide idzachita nawo kupanga 2-chloroethanol.Popeza njira ya chlorohydrin yachotsedwa pakupanga, mankhwala ake apakatikati, 2-chloroethanol, sizichitika mwanjira ya oxidation mwachindunji.Popanga zida zachipatala, zida zina zopangira zimakhala ndi zinthu zowoneka bwino za ethylene oxide ndi 2-chloroethanol, chifukwa chake kuwongolera kuchuluka kwawo kotsalira kuyenera kuganiziridwa pozisanthula pambuyo potseketsa.Kuphatikiza apo, popanga zida zamankhwala, zida zopangira, zowonjezera, zoletsa zochita, ndi zina zotere zimakhala ndi mchere wachilengedwe monga ma chlorides, ndipo zikapangidwa chosawilitsidwa, kuthekera kwakuti ethylene oxide imatsegula mpheteyo pansi pa acidic kapena zamchere, imakumana ndi SN2. anachita, ndipo Chili ndi ufulu chlorine zoipa ayoni kupanga 2-chloroethanol ayenera kuganiziridwa.
Pakalipano, njira yomwe imagwiritsidwa ntchito pozindikira ethylene oxide, 2-chloroethanol ndi ethylene glycol ndiyo njira ya gasi.Ethylene oxide imatha kudziwikanso ndi njira ya colorimetric pogwiritsira ntchito pinched red sulfite test solution, koma kuipa kwake ndikuti kutsimikizika kwa zotsatira za mayeso kumakhudzidwa ndi zinthu zambiri pazoyeserera, monga kuonetsetsa kutentha kosalekeza kwa 37 ° C mu malo oyesera kuti athe kuwongolera momwe ethylene glycol imayendera, komanso nthawi yoyika yankho kuti liyesedwe pambuyo pakukula kwamtundu.Choncho, kutsimikiziridwa kwa njira zotsimikizirika (kuphatikizapo kulondola, kulondola, kufanana, kukhudzidwa, ndi zina zotero) mu labotale yoyenerera ndizofunika kwambiri pakuzindikira kuchuluka kwa zotsalira.
III.Malingaliro pa ndondomeko yobwereza
Ethylene oxide, 2-chloroethanol ndi ethylene glycol ndizotsalira zotsalira pambuyo pochotsa ethylene oxide pazida zamankhwala.Kuti mufufuze zotsalira, kukhazikitsidwa kwa zinthu zofunikira pakupanga ndi kusunga ethylene oxide, kupanga ndi kutseketsa kwa zida zamankhwala kuyenera kuganiziridwa.
Palinso zinthu zina ziwiri zomwe ziyenera kuyang'ana pa ntchito yeniyeni yowunikira zida zachipatala: 1. Kaya kuli kofunikira kuyesa zotsalira za 2-chloroethanol.Popanga ethylene oxide, ngati njira yachikhalidwe ya chlorohydrin imagwiritsidwa ntchito, ngakhale kuyeretsedwa, kusefera ndi njira zina zidzatengedwa popanga, ethylene oxide mpweya udzakhalabe ndi mankhwala apakatikati a 2-chloroethanol pamlingo wina, ndi kuchuluka kwake kotsalira. ziyenera kuunika.Ngati makutidwe ndi okosijeni njira ntchito, palibe kumayambiriro 2-chloroethanol, koma yotsalira kuchuluka kwa zoletsa zogwirizana, chothandizira, etc. mu ethylene okusayidi anachita ndondomeko ayenera kuganizira.Zipangizo zamankhwala zimagwiritsa ntchito madzi ambiri a mafakitale popanga, ndipo ma ion a hypochlorite ndi klorini amalowetsedwa muzinthu zomalizidwa, zomwe zimapangitsa kukhalapo kwa 2-chloroethanol muzotsalira.Palinso milandu kuti zipangizo ndi ma CD zipangizo zachipatala ndi inorganic mchere munali elemental chlorine kapena polima zipangizo ndi dongosolo khola ndi zovuta kuswa chomangira, etc. Choncho, m`pofunika bwinobwino kusanthula ngati chiopsezo 2-chloroethanol. zotsalira ziyenera kuyesedwa kuti ziwunikidwe, ndipo ngati pali umboni wokwanira wosonyeza kuti sichidzalowetsedwa mu 2-chloroethanol kapena ndi yotsika kusiyana ndi malire a njira yodziwira, mayesero akhoza kunyalanyazidwa kuti athetse chiopsezo chake.2. Kwa ethylene glycol Kuwunika kwa zotsalira.Poyerekeza ndi ethylene okusayidi ndi 2-chloroethanol, kukhudzana kawopsedwe za ethylene glycol zotsalira ndi otsika, koma chifukwa ethylene oxide kupanga ndi ntchito komanso poyera ndi mpweya woipa ndi madzi, ndi ethylene okusayidi ndi madzi sachedwa kutulutsa ethylene glycol, ndi Zomwe zili mu ethylene glycol pambuyo potseketsa zimagwirizana ndi kuyera kwa ethylene oxide, komanso zokhudzana ndi kulongedza, chinyezi mu tizilombo toyambitsa matenda, ndi kutentha ndi chinyezi cha chilengedwe, choncho, ethylene glycol iyenera kuganiziridwa molingana ndi zochitika zenizeni. .Kuwunika.
Miyezo ndi imodzi mwa zida zowunikiranso luso lazida zamankhwala, kuunikanso kwaukadaulo kwa zida zamankhwala kuyenera kuyang'ana kwambiri zofunikira zachitetezo ndikuchita bwino kwa kapangidwe kazinthu ndi chitukuko, kupanga, kusungirako, kugwiritsa ntchito ndi mbali zina za kusanthula kwathunthu kwa zinthu zomwe zimakhudza. chitetezo ndi mphamvu ya chiphunzitso ndi mchitidwe, zochokera sayansi, zochokera mfundo, osati mwachindunji kutchula muyezo, ochotsedwa ku mkhalidwe weniweni wa mankhwala kapangidwe, kafukufuku ndi chitukuko, kupanga ndi ntchito.Ntchito yowunikirayi iyenera kuyang'anitsitsa kwambiri machitidwe opanga zida zamankhwala kuti athe kuwongolera maulalo oyenerera, nthawi yomweyo kuwunika kwapatsamba kuyeneranso kukhala "vuto" lolunjika, kupereka gawo lonse la "maso" kusintha khalidwe la ndemanga, cholinga cha ndemanga zasayansi.
Gwero: Center for Technical Review of Medical Devices, State Drug Administration (SDA)
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Nthawi yotumiza: Sep-21-2023