Motafunge rodium, raws li cov tshiab Echinocandin Antifungal tshuaj, tau dhau los ua kev xaiv tseem ceeb hauv kev kho mob kab mob ntawm kev kho mob ntawm fungal (ifi). Cov qauv qhia yog cov kab mob fungal los ntawm aspergillus thiab candida, ua pa cov kab mob fungal, thiab cov kab mob plab zom mov. Clinically, nws tseem siv ua ke nrog amphouricicin thiab triazole cov tshuaj tiv thaiv kab mob antifungal. Tam sim no, qhia txog nws cov kev ua kom huv, kev cia siab, thiab muaj kev xav tau tsuas yog siv ion txauv cov papomized. Ion txauv cov chromatography yog lub sijhawm ua haujlwm thiab siv zog ua haujlwm. Xav txog cov thermal rhiab ntawm MICAFRJING SODEY, muaj kev ua kom yooj yim, muaj kev lag luam yooj yim dua, thiab yog qhov yooj yim rau teev nce kev lag luam.
Peb Cov Khoom
Micafunggin sodium +. Coa
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Daim Ntawv Pov Thawj Kev Ntsuam Xyuas |
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Compound npe |
Motafunge rodium | |
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Cas Tsis tau. |
208538-73-2 | |
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Teem nqi |
Kws Tshuaj Ntsuam Xyuas | |
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Qho ntau |
Me nyuam | |
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Ntim txheem ntim |
Me nyuam | |
| Tus tsim | Shaanxi Bloom Tech Co., Ltd. | |
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Lauj tsis tau. |
20250109001 |
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Mfg |
Jan 12th 2025 |
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Tus txeeb |
Jan 8th 2029 |
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Lub tsev |
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| Kuaj Tus Qauv | GB \/ T 24768-2009 kev lag luam. Stnndard | |
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Yam |
Kev Lag Luam Kev Lag Luam |
Kev tsom xam tau |
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Kev tshwm sim |
Dawb lossis yuav luag dawb hmoov |
Hloov |
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Dej Cov Ntsiab Lus |
Tsawg dua los yog sib npaug rau 4.5% |
0.30% |
| Poob rau ziab |
Tsawg dua los yog sib npaug rau 1. 0% |
0.15% |
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Cov hlau hnyav |
PB tsawg dua lossis sib npaug rau 0. 5ppm |
N.D. |
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Tsawg dua li lossis sib npaug rau 0. 5ppm |
N.D. | |
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Hg tsawg dua lossis sib npaug rau 0. 5ppm |
N.D. | |
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CD tsawg dua lossis sib npaug rau 0. 5ppm |
N.D. | |
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Purity (hplc) |
Ntau dua los yog sib npaug rau 99. 0% |
99.5% |
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Ib Leeg Cav |
<0.8% |
0.48% |
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Residue ntawm ignition |
<0.20% |
0.064% |
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TAG NRHO LICBIAL COUNT |
Tsawg dua li lossis sib npaug rau 750cfu \/ g |
80 |
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E. coli |
Tsawg dua los yog sib npaug rau 2mpn \/ g |
N.D. |
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Tus ntses siav |
N.D. | N.D. |
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Ethanol (los ntawm gc) |
Tsawg dua los yog sib npaug rau 5000ppm |
400ppm |
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Chaw ntim khoom |
Khaws rau hauv ib lub kaw, tsaus thiab qhuav qhov chaw ntawm -20 degrees |
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Motafunge rodiumTsis tsuas yog muaj kev ua haujlwm siab rau Candida thiab Aspergillus genera, tab sis kuj tiv thaiv Azole thiab amvoericinin b resist hom. Nws tuaj yeem siv nyob ib leeg lossis sib xyaw ua ke nrog lwm cov tshuaj tiv thaiv antifungal los kho candidiasis thiab aspergillosis nyob rau hauv patents nrog kev tiv thaiv kev tiv thaiv nrog kev tiv thaiv kab mob. Nws tau kuj tau pom tias muaj txiaj ntsig hauv kev tiv thaiv fungal kab mob hauv PATEGOING CELLOING STEM CELLLANCE CARLLANTATION. Kev ua tau zoo ntawm MCM ua ke nrog rau lwm cov tshuaj tiv thaiv kab mob rau cov kab mob fungal tau txais kev saib xyuas dav dav, tab sis cov kev tshawb fawb tshwj xeeb tsis tau tshaj tawm.
Ib qho kev tshawb nrhiav Japanese tau ua rau 70 patents nrog kev tsis txaus ua aspergillosis thiab candidiasis. Cov txiaj ntsig zoo ntawm MCM rau aspergillosis yog 57.1%, thiab qhov tshwm sim ntawm cov txiaj ntsig zoo uas cuam tshuam nrog MCM yog 17.9%, tab sis tsis muaj tshuaj cuam tshuam txog cov xwm txheej tsis zoo tau tshwm sim. Cov kev tshawb fawb tau qhia tau tias kev siv MCM hauv kev kho mob ntawm kev ua aspergillosis tsis muaj peev xwm ua tau zoo. Hauv lwm qhov kev tshawb nrhiav kev kho mob uas cuam tshuam nrog 22% ntawm cov menyuam yaus, cov txiaj ntsig tau qhia tau zoo sib xws ntawm cov menyuam yaus thiab cov laus. Kev tshawb fawb hauv Nyij Pooj tau pom tias txoj kev ua tiav ntawm cov khoom no hauv kev kho cov tshuaj lom neeg aspergillosis thiab 55% (12\/22) ua cov roj ntsha aspergillosis.
Phau Ntawv Sau Txog Kev Cai
Lwm qhov kev sim ua tau pom tias cov khoom no muaj kev nyab xeeb thiab ua tau zoo rau thaum ntxov thiab khaws cia cov kev pheej hmoo ntawm cov kev pheej hmoo ntawm cov pulmonary aspergillosis. Rau patents nrog fungal corneal mob siab, 0. 1% qhov muag tee ntawm cov khoom no tau thov tag nrho, pib ib zaug ib teev. Tom qab kev tsim epithelial, cov tshuaj osage tau hloov mus rau tsib qhov muag poob ib hnub. Cov tshuaj tau txuas ntxiv mus rau ib hlis tom qab ploj ntawm insterstittitial infiltration, thiab txhua tus patents rov qab los ntawm lawv lub zeem muag. Cov poov xab tau pom hauv lub qhov muag uliabd smears ntawm cov patents, nrog 2 kis tau zoo rau cov kab mob rwj fab. Qhia tias {{{4 4}}. 1% ntawm cov khoom no lub qhov muag muaj zog muaj cov poov xab zoo li cov poov xab muaj feem cuam tshuam.
Kev Cuam Tshuam ntawm 12.5, 50, 75, thiab 100mg \/ d ntawm cov khoom no tau siv los kho 120 pab patents nrog esophageal candidiasis. Cov txiaj ntsig tau pom tias txhua tus patents cov tsos mob txhim kho, tshwj xeeb hauv 75-d thiab 100mg \/ d cov nyhuv kho tau tshwj xeeb. Intravenous Txoj kev lis ntshav ntawm cov khoom no muaj qhov cuam tshuam tseem ceeb kho ntawm HIV zoo patents kis nrog esophageal candida. Nyob rau hauv lub thoob ntiaj teb multicenter, cov kab dig muag ob zaug uas cuam tshuam nrog oophageal candidiasis, kev ua tau zoo ntawm cov khoom lag luam no tau muab piv nrog cov khoom siv fluconazole 200mg \/ d rau 14 hnub. Cov txiaj ntsig tau pom tias ob muaj kev ua tau zoo sib xws, nrog kho mob kho tus nqi ntawm 94.2% thiab 94.6%, feem. Tom qab 2-4 lub lis piam ntawm kev kho, qhov kev rov qab dua yog 15.2% thiab 11.3%, feem. AIDS patents nrog esophageal candidiasis tau muab MCM50, 25 thiab 12.5 mg \/ d feem, thiab lub qhov kev ua tau zoo txo nrog cov tshuaj tua. Cov kev kho mob ntawm MCM qhia txog ib qho koob tshuaj rau ib qho tshuaj uas muaj ib qho chaw kuaj mob ntawm ntau dua lossis sib npaug rau 50mg \/ d. Ntawm cov koob tshuaj ntau, qhov ploj ntawm cov tsos mob tshwm sim sai dua thiab ntau dua.
3) Candidemia
Nyob rau hauv ib qho kev xaiv kab ntawv qhib kev kawm txog 119 patents (101 tus neeg laus thiab 18 ntawm 68 patents (86.5%) muaj cov kab mob uas tsis tau sib ntaus sib tua. Cov neeg laus ({{{50-100) mg \/ d thiab cov menyuam ({}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}} Cov txiaj ntsig tau pom tias kev ua tau zoo ntawm cov khoom no hauv kev kho cov kab ke ntawm kev kho tus kab mob uas tsis yog 83.2% ntawm cov patents tsis tau hnov Neutropenia. Cov lus teb rau ntau hom sib txawv: candida albicans yog 85% (39\/46), Candida Albicans yog 93% (28\/21). Kab lus yog:. Kaum ob qhov mob ntawm malignant cov kab mob Hematological nyuab nrog kev mob fungalological tau tshaj tawm nyob rau hauv Suav teb, nrog tag nrho cov kev kho mob muaj txiaj ntsig ntawm 66.7% siv tshuaj ntawm 100mg \/ d. Cov kev kuaj mob hauv qhov kuaj mob thiab cov neeg xav tias muaj qee tus neeg mob tau 57.1% (4\/5), feem, nrog lub sijhawm hnub ntawd {37}} hnub.
Txij li thaum xyoo 199 0 s, fluconazole tau siv ntau los tiv thaiv cov kab mob fungal, ua rau muaj qee leej fluconazole resistant cov kab mob. Ib tug randomized, ob-qhov muag tsis pom kev, sib piv theem III cov tshuaj ntsuam xyuas tau ua cov tshuaj tiv thaiv kev ua haujlwm los ntawm kev tswj hwm ntawm MCM los ntawm ITropenia hematopoietic qia cell hloov. Cov txiaj ntsig tau pom tau tias tag nrho cov txiaj ntsig tau zoo ntawm MCM tau nce siab dua fluconazole, ntawm 80.0%, feem ntau, thiab kev kho mob yog luv dua. MCM tuaj yeem tiv thaiv cov kab mob fungal hauv patents nrog neutropenia. Tebchaws Asmeskas FDA tau pom zoo cov khoom no rau kev tiv thaiv thiab kho cov ntshav ntawm cov ntshav candidiasis hauv paus ntshav hloov ntshav. Qhov kev pom zoo siv rau cov neeg laus yog 50mg \/ d li cov tshuaj tiv thaiv ua ntej kev hloov kho ntawm tes; Qhov ntau npaum li cas rau kev kho esophageal candidiasis yog 150mg \/ d, tswj hwm enavenously rau 1 teev. Kev tshawb fawb ntxiv yog xav tau los txiav txim sebmotafunge rodiumYuav siv tau los ua cov tshuaj tiv thaiv kev tiv thaiv hematopoietic qia cell hloov thiab txhim kho lawv lub sijhawm ntev.
Pharmaconinetics
1. Tsiaj
Txoj kev tshawb fawb ntawm 14C muab cov tshuaj tua kab mob ntawm lub cev, tshwj xeeb yog cov plab zom mov thiab cov plab hnyuv siab raum, uas tej zaum yuav yog cov kabmob loj cuam tshuam los ntawm kev sib sib zog nqus fungi. Nyob rau tib lub sijhawm, txoj kev tshawb no tau pom tias txawm tias o tuaj yeem ua rau cov tshuaj fungal, lub peev xwm ntawm MCM nkag mus rau hauv lub hlwb (tsuas yog 2% ntawm cov tshuaj tiv thaiv ntshav). Cov txiaj ntsig tau pom tias cov ntaub so ntswg kev ua kom pom tseeb ntawm MICAFUNGGIN tau linear thaum lub tshuaj \/ kg, thiab nws tau txhawb nqa kev kis tus kab mob fungal. Lub ntsiab excretion txoj kev yog los ntawm Bile excretion.
2. Tib neeg lub cev
Micafenjing sodium muaj qhov tsis haum ntawm qhov ncauj kev nqus thiab tsuas yog ua tau lees paub. Raws li Tshaj Tawm Mus, MCM75MG, Kev txhaj tshuaj tiv thaiv kom tsis txhob muaj hnub nyoog 79.8% ntawm cov tshuaj tsis muaj txiaj ntsig ntau dua 9m thiab hnub nyoog thib 3, tsis qhia txog cov tshuaj 4ma uas tsis tau hloov pauv ntawm MCM. Lwm cov kev tshawb fawb tau pom tias lub plasma AUC ntawm kev faib tawm cov khoom noj muaj zog xws li kev faib tawm ib nrab (VSS), thiab tag nrho cov kev tshem tawm (cl) tsis hloov nrog koob tshuaj. Tus zis rov qab tus nqi tsawg dua 1%, thiab cov tshuaj feem ntau tau tawm ntawm txoj hnyuv los ntawm bile los ntawm bile thiab quav. Vim tias muaj ntau lub cuab tam sim ua tsis tau, cov tshuaj tsis taus ntawm cov tshuaj feem ntau hloov pauv cov neeg laus. Txawm li cas los xij, kev kawm piv cov neeg ua yeeb yam ntawm cov neeg laus uas tsis muaj kev cuam tshuam nrog cov tshuaj uas tsis muaj hnub nyoog li ntawm cov tshuaj paporokininin. Tsis tas li ntawd, tsis muaj kev hloov pauv ntawm lub neej ib nrab-lub neej ntawm kev pab cuam lub siab thiab lub raum tsis muaj kev pab dawb, yog li nws tuaj yeem raug txiav txim siab ua haujlwm ntawm cov tshuaj raws li tus neeg mob.
3. Cov metabolism
Qhov kev tshem tawm ib nrab-lub neej ntawm MicafenJing sodium hauv cov patents noj qab haus huv, thaum tus neeg tuaj yeem pab kas-}. {}}. 5 teev. MCM0.5mg \/ kg tau muab rau cov menyuam yaus hnub nyoog {8}}}}} hnub nyoog nrog lub neej ib nrab ntawm {10}} teev. Txawm li cas los xij, ntawm qhov koob tshuaj ntawm 1mg \/ kg, lub neej ib nrab hloov los ntawm {13}}}} sijhawm tom qab tswj hwm mus rau 93 teev. Micafenjing sodium yog feem ntau metabolized nyob rau hauv daim siab, nrog kwv yees li 40% qhia hauv daim ntawv ntawm nws daim qauv qub thiab metabolites nyob rau hauv bile. Kwv yees li 15% ntawm cov tshuaj yog tshem tawm los ntawm lub raum nyob hauv daim qauv qauv qauv, tab sis cov kev kawm tshwj xeeb ntawm cov metabolism tsis meej.
R & D Txheej Txheem thiab Kev Nkag Mus Nkag
Astellas Pharma Inc. hauv Nyij Pooj tau pom zoo ua ntej rau cov npe hauv qab lub npe hu ua "myCamine" ®).
Pom zoo los ntawm US FDA rau kev tiv thaiv thiab kho ntawm Esophageal Candidiasis, pob txha pob txha pob txha, thiab Neutropenia hauv cov neeg mob AIDS.
Motafunge rodiumTau pom zoo nyob hauv Suav teb thiab cov ntsiab lus tau nthuav dav kom muaj kab mob fungal, ua pa cov kab mob fungal, thiab cov kab mob plab zom mov.
Kev lag luam thoob ntiaj teb yuav mus txog 621 lab daus las US22, thiab yuav tsum nce nyiaj rau 948 lab daus las xyoo 2029, nrog rau cov lej sib xyaw txhua xyoo (Cagram ntawm 6.2%.
Cim npe nrov: MICAFUNGIN SODEJ, cov chaw muag khoom, chaw tsim khoom, chaw tsim khoom, chaw lag luam, lag luam wholesale, yuav, nqe, loj, loj, rau muag