Izinto ezisetyenziswayo ezingena-pyrogen ziyinto etyiwayo ngaphandle kwe-endotoxin yangaphandle, kubandakanywa iingcebiso zepipette ezingena-pyrogen (ibhokisi yetip), iityhubhu zokuvavanya ezingenazo ipyrogen okanye ezibizwa ngokuba yi-endotoxin yeetyhubhu zeglasi ezisimahla, ii-ampoules zeglasi ezingena-pyrogen, i-endotoxin-free 96-well-well microplates, kunye ne-endotoxin- amanzi asimahla (ukusetyenziswa kwamanzi ane-depyrogenated kuvavanyo lwe-endotoxin yebhaktiriya), I-endotoxin yamahhala ye-buffer kunye njl. Phakathi kwazo, amanzi e-endotoxintest ye-bacterial nge-gel clot method kunye ne-quantitative endotoxin test assay kuzo zonke ii-Pharmacopoeia editions ezinxulumene (USP, EP, BP, JP kunye ne-China Pharmaceutica). Ibhekisa kumanzi acwebileyo okutofwa ngomxholo we-endotoxin ngaphantsi kwe-0.015EU/ml. Ngoku inguqulelo yamva nje ye-Pharmacopoeia, amanzi e-BET angaphantsi kwe-0.005EU/ml. Nokuba umgangatho ophezulu ungaphantsi kwe-0.001EU / ml iyakwazi ukuveliswa kunye nokunikezelwa yi-Bioendo.
Inkcazo inikezela ngenkcazo ecacileyo yezinto ezisetyenziswayo ezingenazo i-pyrogen kunye nokusetyenziswa kwazo, ngokukodwa kugxininisa indima yabo ebalulekileyo kuvavanyo lwe-endotoxin kwimigangatho eyahlukeneyo ye-pharmacopoeia. Nasi isishwankathelo samanqaku aphambili:
- Ingcaciso:
- Izinto ezisetyenziswayo ezingenaPyrogen zizinto ezingenazo i-endotoxins zangaphandle, kuquka:
- Iingcebiso zepipette ezingena-Pyrogen(ibhokisi yeengcebiso).
- Iityhubhu zovavanyo ezingenazo i-Endotoxin okanye iityhubhu zeglasi.
- Ii-ampoules zeglasi ezingenayo i-endotoxin.
- I-Endotoxin-free 96-well-well microplates.
- Amanzi angenayo i-Endotoxin (amanzi angenayo i-depyrogenated).
- I-endotoxin-free buffers.
- Izinto ezisetyenziswayo ezingenaPyrogen zizinto ezingenazo i-endotoxins zangaphandle, kuquka:
- Amanzi oVavanyo lwe-Endotoxin yeBhaktiriya (BET):
- Isetyenziswe kwiindlela ze-gel clot kunye neemvavanyo zobungakanani be-endotoxin ngokwe-USP, i-EP, i-BP, i-JP, kunye nemigangatho ye-Pharmacopeia yase-China.
- Umgangatho wangaphambili: ≤0.015 EU/ml yamanzi ayinyumba yokutofa.
- Imfuno yangoku (i-pharmacopoeia yakutshanje): ≤0.005 EU / ml yamanzi e-BET.
- Umgangatho ophezulu: I-Bioendo inokuvelisa amanzi kunye ≤0.001 EU / ml umxholo we-endotoxin, ukuhlangabezana neemfuno eziphezulu zomgangatho.
Iingcebiso zokuCokisa:
- Gxininisa umda wesicelo, umzekelo, iilabhoratri, amayeza, okanye i-biotech.
- Nikeza iinkcukacha ezongezelelweyo malunga nobuchule be-Bioendo kwimveliso ukuqinisa umda wayo wokukhuphisana.
- Gxininisa iingenelo ezithile zeemveliso zomgangatho ophezulu we-Bioendo, ezifana nokuchaneka okuphuculweyo kovavanyo okanye ukuthotyelwa kwemithetho.
Ngaba ungathanda ukuba ndikuncede ndiyile oku kwimveliso esesikweni okanye inkcazelo yobugcisa?
Amagama aphambili ahambelanayo e-endotoxins, kunye ne-endotoxin esetyenziswa simahla, ipyrogen kunye nemithombo yobushushu zikhonsepthi ezimbini ezahlukeneyo ngokupheleleyo:IProjeni: Ikwabizwa ngokuba yipyrogen okanye exothermic factor. izinto ezinokubangela ukwanda kobushushu bomzimba.Umthombo wobushushu: Into ekhupha ubushushu. Okufana nokutshisa iimatshisi, amalahle, njl-njl.Okubizwa ngokuba yi "non-pyrogenic consumables" kunye "nempendulo ye-pyrogenic" yabanye abavelisi kunye nabarhwebi ngokwenene ngamagama angenamsebenzi kwaye alahlekisayo. Ezona zichanekileyo kufuneka zibe "I-Pyrogen Free" kunye ne "Pyrogen Response".
Kutheni le nto izinto ezisetyenziswayo zasimahla zePyrogen ziyimfuneko kuvavanyo lovavanyo lwe-endotoxin, zombini i-gel clot endotoxin test assay kunye ne-endotoxin test assay?
Ewe, i-pyrogen-free consumables ibalulekile ekwenzeni uvavanyo lovavanyo lwe-endotoxin ngokuchanekileyo nangokuthembeka.Ubukho be-pyrogens, okuyizinto ezibangela umkhuhlane ovame ukuvela kwi-endotoxins yebhaktiriya, inokuphazamisa iziphumo zovavanyo kwaye ikhokelele ekufundweni kobuxoki. uvavanyo lwe-endotoxin, eyaziwa ngokuba yi-Limulus amebocyte lysate (LAL) okanye ebizwa ngokuba yi-Lyophilized Uvavanyo lwe-amebocyte lysate (LAL), lusetyenziselwa ukufumanisa kunye nokulinganisa ubukho be-endotoxins yebhaktheriya kumayeza, izixhobo zonyango kunye nezinye iimveliso. Uvavanyo lwe-LAL luxhomekeke kwimpendulo phakathi kwe-reagent ye-LAL kunye ne-endotoxins ukuvelisa i-clotting okanye impendulo ye-chromogenic.Ukuqinisekisa iziphumo ezichanekileyo, kubalulekile ukusebenzisa izinto ezisetyenziswayo ezingenazo iipyrogens. I-Pyrogens inokungcolisa izinto ezahlukeneyo zebhubhoratri, kubandakanywaiglasi, iingcebiso zepipette, iityhubhu, kunye nezikhongozeli zeesampulu. Ukuba izinto ezisetyenziswayo ezingcolisekileyo ngepyrogen zidibana ne-reagent ye-LAL okanye iisampuli zovavanyo, zinokubangela iimpendulo ezingeyonyani, ezikhokelela kwizigqibo eziphosakeleyo malunga nobukho okanye ukuxinana kwee-endotoxins. ubukho be-pyrogens. Bangena kwiinkqubo ezingqongqo zolawulo lomgangatho ukuqinisekisa ukuba bayahlangabezana nemigangatho efunekayo yovavanyo lwe-endotoxin. Ukusebenzisa ezi zinto zokusetyenziswa ezikhethekileyo kunceda ukugcina ingqibelelo kunye nokuchaneka kovavanyo lovavanyo lwe-endotoxin, ukuqinisekisa iziphumo ezithembekileyo kunye nokukhuthaza ukhuseleko lwesigulane kwi-pharmaceutical and biomedical applications.
Ixesha lokuposa: Nov-07-2022