Abubuwan da ba su da pyrogen sune abubuwan da ake amfani da su ba tare da endotoxin na waje ba, gami da tukwici na pipette marasa pyrogen (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 (amfani da ruwa na depyrogenated a cikin gwajin endotoxin na kwayan cuta), buffer free endotoxin da sauransu. Daga cikin su, ruwa don endotoxintest na kwayan cuta ta hanyar gel clot da kuma ƙididdigar 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.
Bayanin yana ba da cikakken bayyani game da abubuwan da ba su da pyrogen da aikace-aikacen su, musamman suna jaddada muhimmiyar rawar da suke takawa a gwajin endotoxin a cikin ma'auni daban-daban na pharmacopoeia. Ga taƙaitaccen mahimman bayanai:
- Ma'anarsa:
- Abubuwan da ba su da pyrogen abubuwa ne marasa ƙarancin endotoxins, gami da:
- Tukwici na pipette marasa Pyrogen(akwatin tip).
- Bututun gwaji marasa Endotoxin ko bututun gilashi.
- Ampoules gilashin-free endotoxin.
- Microplates masu rijiyoyin 96 marasa kyauta na Endotoxin.
- Ruwan da ba shi da endotoxin (ruwa depyrogenated).
- Endotoxin-free buffers.
- Abubuwan da ba su da pyrogen abubuwa ne marasa ƙarancin endotoxins, gami da:
- Ruwa don Gwajin Endotoxin Bacterial (BET):
- An yi amfani da shi a hanyoyin jini na gel da gwaje-gwajen endotoxin na ƙididdigewa kamar yadda USP, EP, BP, JP, da China Pharmacopeia ka'idojin.
- Matsayin da ya gabata: ≤0.015 EU/ml don ruwan bakararre don allura.
- Abubuwan da ake buƙata na yanzu (sabon pharmacopoeia): ≤0.005 EU/ml don ruwan BET.
- Babban ma'auni: Bioendo zai iya samar da ruwa tare da ≤0.001 EU / ml endotoxin abun ciki, saduwa da mafi ingancin bukatun.
Shawarwari don Gyarawa:
- Jaddada iyakar aikace-aikacen, misali, dakunan gwaje-gwaje, magunguna, ko fasahar kere-kere.
- Bayar da ƙarin cikakkun bayanai kan ƙwarewar Bioendo a cikin masana'anta don ƙarfafa gasa.
- Haskaka takamaiman fa'idodin samfuran samfuran Bioendo, kamar ingantattun daidaiton ƙima ko bin ƙa'ida.
Kuna so in taimaka ƙera wannan zuwa ƙarin samfuri ko bayanin fasaha?
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. Irin su ƙona ashana, gawayi, da dai sauransu.Waɗanda ake kira "masu amfani da ba-pyrogenic" da "amsar pyrogenic" na wasu masana'antun da 'yan kasuwa a zahiri sunaye marasa ƙwarewa da yaudara. 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?
Haka ne, abubuwan da ba su da pyrogen suna da mahimmanci don yin gwajin gwajin endotoxin daidai kuma a dogara.Kasancewar pyrogens, wanda ke haifar da zazzaɓi abubuwa sau da yawa ana samun su daga kwayoyin cutar endotoxins, na iya tsoma baki tare da sakamakon gwajin kuma haifar da karatun ƙarya.The gwajin endotoxin, wanda aka fi sani da gwajin Limulus amebocyte lysate (LAL) ko ake kira Lyophilized amebocyte lysate. Gwajin (LAL), ana amfani dashi don ganowa da ƙididdige kasancewar endotoxins na kwayan cuta a cikin magunguna, na'urorin likitanci, da sauran samfuran. Gwajin LAL yana 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 suka gurɓata pyrogen sun haɗu da reagent na LAL ko samfuran gwaji, za su iya haifar da halayen ƙarya, wanda zai haifar da kuskuren yanke shawara game da kasancewar ko tattarawar endotoxins. Ana kera abubuwan amfani marasa amfani da pyrogen kuma an gwada su musamman don ragewa ko kawar da su. 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