Abubuwan da ba su da pyrogen sune abubuwan amfani ba tare da endotoxin na waje ba, gami da tukwici na pipette na kyauta (akwatin tip), bututun gwajin kyauta na pyrogen ko kuma ana kiran bututun gilashin kyauta na endotoxin, ampoules gilashin pyrogen-free, 96-free microplates endotoxin-free, da endotoxin- ruwa kyauta (yin amfani da ruwa mai lalata a cikin gwajin endotoxin na kwayan cuta), buffer free endotoxin da sauransu. Daga cikin su, ruwan don kwayoyin endotoxintest ta hanyar gel clot da kuma gwajin gwajin gwaji na endotoxin a cikin dukkanin bugu na Pharmacopoeia (USP, EP, BP, JP) da China Pharmaceutica).Yana nufin bakararre ruwa don allura tare da abun ciki na endotoxin kasa da 0.015EU/ml.Yanzu sabon sigar Pharmacopoeia, ruwan BET bai kai 0.005EU/ml ba.Ko da ma'auni mafi girma shine ƙasa da 0.001EU/ml ana iya samarwa da samarwa ta Bioendo.
Mahimman kalmomi masu alaƙa na endotoxins, da abubuwan amfani na kyauta na endotoxin, pyrogen da tushen zafi sune mabambantan ra'ayoyi guda biyu:Pyrogen: Har ila yau ake kira pyrogen ko exothermic factor.abubuwan da zasu iya haifar da haɓakar zafin jiki.Tushen Zafi: Abu ne mai fitar da zafi.Kamar kona ashana, gawayi da sauransu.Abin da ake kira "masu amfani da ba-pyrogenic" da "amsar pyrogenic" na wasu masana'antun da 'yan kasuwa a zahiri sunaye marasa ƙwararru da ɓatarwa.Madaidaitan ya kamata su zama "Pyrogen Free" da "Amsar Pyrogen".
Me yasa abubuwan amfani da Pyrogen kyauta suka zama dole a cikin gwajin gwajin endotoxin, duka biyun gel clot endotoxin gwajin gwaji da gwajin gwajin endotoxin na adadi?
Ee, abubuwan da ba su da pyrogen suna da mahimmanci don yin gwajin gwajin endotoxin daidai da dogaro.Kasancewar pyrogens, wadanda sune abubuwan da ke haifar da zazzabi sau da yawa ana samo su daga kwayoyin endotoxins, na iya tsoma baki tare da sakamakon gwajin kuma ya haifar da karatun ƙarya.Gwajin endotoxin, wanda aka fi sani da gwajin Limulus amebocyte lysate (LAL) ko kuma ake kira gwajin Lyophilized amebocyte lysate (LAL), ana amfani da shi don ganowa da ƙididdige kasancewar endotoxins na ƙwayoyin cuta a cikin magunguna, na'urorin likitanci, da sauran samfuran.Gwajin LAL ya dogara ne akan amsawa tsakanin reagent na LAL da endotoxins don samar da amsawar jini ko chromogenic.Don tabbatar da ingantaccen sakamako, yana da mahimmanci a yi amfani da abubuwan amfani waɗanda ba su da pyrogens.Pyrogens na iya gurbata kayan aikin dakin gwaje-gwaje daban-daban, gami dagilashin gilashi, tukwici na pipette, bututu, da kwantena samfurin.Idan abubuwan da aka gurbata da pyrogen sun haɗu da reagent na LAL ko samfuran gwaji, za su iya haifar da halayen ƙarya, wanda zai haifar da kuskuren ƙarshe game da kasancewar ko tattarawar endotoxins.Ana kera abubuwan da ba su da pyrogen kuma an gwada su musamman don ragewa ko kawar da kasancewar pyrogens.Suna fuskantar tsauraran matakan sarrafa inganci don tabbatar da cewa sun cika ka'idojin da ake buƙata don gwajin endotoxin.Yin amfani da waɗannan kayan masarufi na musamman yana taimakawa kiyaye mutunci da daidaiton ƙimar gwajin endotoxin, tabbatar da ingantaccen sakamako da haɓaka amincin haƙuri a cikin aikace-aikacen magunguna da ƙwayoyin cuta.
Lokacin aikawa: Nuwamba-07-2022
