Izinto ezisetshenziswayo ezingena-pyrogen ziyizinto ezidlekayo ezingenayo i-endotoxin yangaphandle, okuhlanganisa namathiphu e-pipette angenayo i-pyrogen (ibhokisi lethiphu), amashubhu okuhlola angenayo i-pyrogen noma abizwa ngamashubhu engilazi angenayo i-endotoxin, ama-ampoule engilazi angenayo i-pyrogen, ama-microplates angenayo i-endotoxin-free 96-well, kanye ne-endotoxin- amanzi amahhala (ukusetshenziswa kwamanzi ane-depyrogenated ekuhlolweni kwe-bacterial endotoxin), i-endotoxin free buffer nokunye. Phakathi kwazo, amanzi e-bacterial endotoxintest by gel clot method kanye ne-quantitative endotoxin test assay kukho konke okuhlobene ne-Pharmacopoeia editions (USP, EP, BP, JP kanye neChina Pharmaceutica).Isho amanzi angenalutho omjovo anokuqukethwe kwe-endotoxin ngaphansi kuka-0.015EU/ml.Manje inguqulo yakamuva ye-Pharmacopoeia, amanzi e-BET angaphansi kuka-0.005EU/ml.Ngisho nezinga eliphakeme kakhulu lingaphansi kuka-0.001EU/ml liyakwazi ukukhiqizwa futhi lihlinzekwe yi-Bioendo.
Amagama angukhiye ahlobene we-endotoxins, kanye ne-endotoxin engasetshenziswa mahhala, imithombo ye-pyrogen neyokushisa imiqondo emibili ehluke ngokuphelele:I-Pyrogen: Ibizwa nangokuthi i-pyrogen noma i-exothermic factor.izinto ezingabangela ukwanda kokushisa komzimba.Umthombo Wokushisa: Into ekhipha ukushisa.Okufana nomentshisi ovuthayo, amalahle nokunye.Okubizwa ngokuthi "izinto zokusetshenziswa ezingezona ze-pyrogenic" kanye "nempendulo ye-pyrogenic" yabanye abakhiqizi nabathengisi empeleni amagama angenangqondo kakhulu futhi adukisayo.Okufanelekile kufanele kube "I-Pyrogen Free" kanye "Nempendulo Ye-Pyrogen".
Kungani izinto ezisetshenziswayo ezingenaPyrogen zidingekile ekuhlolweni kokuhlolwa kwe-endotoxin, kokubili ukuhlolwa kokuhlolwa kwehlule lejeli endotoxin kanye nokuhlolwa komthamo we-endotoxin?
Yebo, izinto ezisebenzisekayo ezingenayo i-pyrogen zibalulekile ekwenzeni ukuhlolwa kokuhlolwa kwe-endotoxin ngokunembe nangokuthembekile.Ukuba khona kwama-pyrogens, okuyizinto ezibangela umkhuhlane ngokuvamile ezitholakala kuma-endotoxins amagciwane, kungaphazamisa imiphumela yokuhlolwa futhi kuholele ekufundweni okungamanga.Ukuhlolwa kwe-endotoxin, okuvame ukwaziwa ngokuthi ukuhlolwa kwe-Limulus amebocyte lysate (LAL) noma okubizwa nge-Lyophilized amebocyte lysate (LAL), kusetshenziselwa ukuthola kanye nokulinganisa ubukhona be-endotoxin yebhaktheriya kwezemithi, ezinsizakalweni zezokwelapha, nakweminye imikhiqizo.Ukuhlolwa kwe-LAL kuncike ekuphenduleni phakathi kwe-reagent ye-LAL nama-endotoxins ukuze kukhiqizwe ukujiya noma impendulo ye-chromogenic.Ukuqinisekisa imiphumela enembile, kubalulekile ukusebenzisa izinto ezidlekayo ezingenawo ama-pyrogens.Ama-pyrogens angangcolisa izinto ezahlukahlukene zaselabhorethri, kufaka phakathii-glassware, amathiphu e-pipette, amashubhu, neziqukathi zesampula.Uma izinto ezisebenzisekayo ezingcoliswe i-pyrogen zihlangana ne-reagent ye-LAL noma amasampula okuhlola, zingadala ukusabela okungeyikho, okuholela eziphethweni eziyiphutha mayelana nokuba khona noma ukugxila kwe-endotoxin.Izinto ezisetshenziswayo ezingena-pyrogen ziyakhiqizwa futhi zihlolwe ngokukhethekile ukuze kuncishiswe noma kuqedwe ukuba khona kwama-pyrogens.Babhekana nezinqubo eziqinile zokulawula ikhwalithi ukuze baqinisekise ukuthi bahlangabezana namazinga adingekayo okuhlolwa kwe-endotoxin.Ukusebenzisa lezi zinto ezisetshenziswayo ezikhethekile kusiza ukugcina ubuqotho nokunemba kokuhlolwa kokuhlolwa kwe-endotoxin, ukuqinisekisa imiphumela enokwethenjelwa kanye nokukhuthaza ukuphepha kwesiguli ekusetshenzisweni kwemithi kanye ne-biomedical.
Isikhathi sokuthumela: Nov-07-2022
