Ihe oriri na-adịghị pyrogen bụ ihe oriri na-enweghị endotoxin exogenous, gụnyere ndụmọdụ pipette na-enweghị pyrogen (igbe ntụaka), tubes ule na-enweghị pyrogen ma ọ bụ nke a na-akpọ endotoxin free glass tubes, pyrogen-free glass ampoules, endotoxin-free 96-mma microplates, na endotoxin- mmiri efu (eji mmiri depyrogenated eme ihe na ule endotoxin nke nje bacteria), ihe nchekwa endotoxin free na wdg. N'ime ha, mmiri maka nje bacteria endotoxintest site gel clot usoro na quantitative endotoxin test assay na niile metụtara Pharmacopoeia mbipụta (USP, EP, BP, JP na China Pharmaceutica) . Na-ezo aka na mmiri na-adịghị mma maka injection nwere ọdịnaya endotoxin na-erughị 0.015EU/ml. Ugbu a ụdị Pharmacopoeia kachasị ọhụrụ, mmiri BET erughị 0.005EU/ml. Ọbụna ọkọlọtọ kachasị elu bụ ihe na-erughị 0.001EU / ml nwere ike ịmepụta ma weta ya site na Bioendo.
Nkọwa ahụ na-enye nkọwa zuru ezu nke ihe oriri na-enweghị pyrogen na ngwa ha, na-emesi ike ọrụ ha dị oke mkpa na nyocha endotoxin gafee ụkpụrụ pharmacopoeia dị iche iche. Nke a bụ nchịkọta isi ihe:
- Nkọwa:
- Ihe oriri na-adịghị pyrogen bụ ihe na-enweghị endotoxins, gụnyere:
- Atụmatụ pipette na-enweghị pyrogen(igbe ndụmọdụ).
- Ọkụ ule na-enweghị Endotoxin ma ọ bụ tubes iko.
- Ampoules iko na-enweghị Endotoxin.
- Microplates olulu mmiri 96 na-enweghị Endotoxin.
- Mmiri na-enweghị Endotoxin (mmiri depyrogenated).
- Ihe nchekwa na-enweghị Endotoxin.
- Ihe oriri na-adịghị pyrogen bụ ihe na-enweghị endotoxins, gụnyere:
- Mmiri maka Nnwale Endotoxin Bacterial (BET):
- Ejiri ya na usoro gel clot yana nyocha endotoxin quantitative dị ka USP, EP, BP, JP, na China Pharmacopeia ụkpụrụ.
- Ụkpụrụ mbụ: ≤0.015 EU/ml maka mmiri na-adịghị mma maka ntụtụ.
- Ihe achọrọ ugbu a (pharmacopoeia ọhụrụ): ≤0.005 EU/ml maka mmiri BET.
- Ọkọlọtọ dị elu: Bioendo nwere ike imepụta mmiri na ≤0.001 EU / ml endotoxin ọdịnaya, na-ezute ihe kacha mma chọrọ.
Atụmatụ maka imezigharị:
- Kwado oke ngwa ngwa, dịka, ụlọ nyocha, ọgwụ, ma ọ bụ biotech.
- Nye nkọwa ndị ọzọ na nka Bioendo nwere n'ichepụta iji mesie ike asọmpi ya.
- Kọwapụta uru dị iche iche nke ngwaahịa Bioendo nwere ọkwa dị elu, dị ka nkwalite nyocha nke ọma ma ọ bụ nnabata usoro iwu.
Ọ ga-amasị m ka m nyere aka chepụta nke a ka ọ bụrụ nkọwa ngwaahịa ma ọ bụ nkọwa nka?
Isi okwu ndị metụtara endotoxins, na ihe oriri endotoxin n'efu, pyrogen na isi mmalite okpomọkụ bụ echiche abụọ dị iche kpamkpam:Pyrogen: A na-akpọkwa pyrogen ma ọ bụ ihe exothermic. ihe ndị nwere ike ime ka mmụba ahụ dị elu.Isi iyi ọkụ: Ihe na-ebunye okpomọkụ. Dị ka ọkụ ọkụ, unyi, wdg. Ihe a na-akpọ "ndị na-abụghị pyrogenic consumables" na "nzaghachi pyrogenic" nke ụfọdụ ndị na-emepụta na ndị na-ere ahịa bụ n'ezie aha na-adịghị mma na ndị na-eduhie eduhie. Ndị ziri ezi kwesịrị ịbụ "Pyrogen Free" na "Nzaghachi Pyrogen".
Kedu ihe kpatara ihe oriri na-enweghị Pyrogen ji dị mkpa na nyocha nyocha endotoxin, ma gel clot endotoxin test assay na quantitative endotoxin test assay?
Ee, ihe oriri na-enweghị pyrogen dị mkpa maka ịme nyocha nke endotoxin n'ụzọ ziri ezi na ntụkwasị obi. Ọnụnọ nke pyrogens, bụ ihe ndị na-eme ka ahụ ọkụ na-ebutekarị site na nje bacteria endotoxins, nwere ike igbochi nsonaazụ nke ule ahụ ma duga n'ịgụ ụgha. ule endotoxin, nke a na-akpọkarị Limulus amebocyte lysate (LAL) ule ma ọ bụ nke a na-akpọ Lyophilized amebocyte lysate A na-eji ule (LAL), iji chọpụta na tụọ ọnụnọ nke nje endotoxins na ọgwụ, ngwaọrụ ahụike, na ngwaahịa ndị ọzọ. Nnwale LAL na-adabere na mmeghachi omume dị n'etiti reagent LAL na endotoxins iji mepụta nzaghachi clotting ma ọ bụ chromogenic. Iji hụ na nsonaazụ ziri ezi, ọ dị mkpa iji ihe oriri na-adịghị na pyrogens. Pyrogens nwere ike imerụ ihe ụlọ nyocha dị iche iche, gụnyereiko, ndụmọdụ pipette, tubes, na ihe nlele. Ọ bụrụ na ihe ndị na-emerụ emerụ pyrogen na-abanye na kọntaktị LAL reagent ma ọ bụ ihe nlele ule, ha nwere ike ịkpalite mmeghachi omume na-ezighị ezi, na-eduga ná nkwubi okwu na-ezighị ezi banyere ọnụnọ ma ọ bụ itinye uche nke endotoxins. A na-arụpụta ihe ndị na-enweghị pyrogen na-anwale kpọmkwem iji belata ma ọ bụ kpochapụ ya. ọnụnọ nke pyrogens. Ha na-enweta usoro njikwa mma siri ike iji hụ na ha ruru ụkpụrụ achọrọ maka nnwale endotoxin. Iji ihe oriri ndị a pụrụ iche na-enyere aka ịnọgide na-eguzosi ike n'ezi ihe na izi ezi nke nyocha ule endotoxin, na-ahụ maka nsonaazụ a pụrụ ịdabere na ya na ịkwalite nchekwa onye ọrịa na ngwa ọgwụ na ọgwụ.
Oge nzipu: Nov-07-2022