Amikacin Sulfate (CAS No.: 39831-55-5) - Aminoglycoside Antibacterial rau Cov kab mob hnyav Gram-tsis zoo
Raws li tus kws tshaj lij ntawm cov kws kho mob - qib tshuaj tua kab mob cov khoom xyaw, peb muab siab - Amikacin Sulfate purity uas ua raws li cov qauv tshuaj tshuaj thoob ntiaj teb (USP, EP, BP, CP). Ib tug semi-synthetic aminoglycoside tshuaj tua kab mob muab tau los ntawm kanamycin A, nws nthuav tawm cov kab mob muaj zog tiv thaiv kab mob ntau yam -tiv taus Gram- cov kab mob tsis zoo- suav nrog cov kab mob resistant rau lwm cov aminoglycosides (xws li gentamicin, tobramycin). Nws yog feem ntau siv nyob rau hauvtib neeg tshuajrau kev kho lub neej-kev hem thawj kis kab mob thiab hauv kev xaivkev xyaum ua tsiajrau cov tsiaj nyeg thiab cov tsiaj sib raug zoo, ua haujlwm tseem ceeb "kawg- kab" tus neeg sawv cev tiv thaiv yeeb tshuaj- cov kab mob tiv taus.
Product Basic Information
| Yam khoom | Paub meej |
|---|---|
| Khoom npe | Amikacin Sulfate |
| CAS Nr. | 39831-55-5 |
| Synonyms | O-3-Amino-3-deoxy- -D-glucopyranosyl-(1→6)-O-[6-amin o-6-deoxy- -D-glucopyranosyl-(1→4)]-N¹-(4-amino-2-hydroxybutanoyl)-2-deoxy-D-streptamine sulfate; Amikin® (hom npe rau tib neeg formulations) |
| Molecular Formula | C₂₂H₄₃N₅O₁₃·nH₂SO₄ (feem ntau 2:1 sulfate ntsev, molecular hnyav ~ 781.7) |
| Molecular Luj | ~ 781.7 (rau 2: 1 sulfate ntsev) |
| Qhov tshwm sim | Dawb kom tawm -dawb crystalline hmoov los yog hygroscopic granules; Tsis hnov tsw |
| Specification | - Pharmaceutical Qib: Purity Ntau dua lossis sib npaug li 95.0% (HPLC); Assay (raws li amikacin) 690–770 ug/mg (raws li anhydrous, sulfate-dawb hauv paus); Poob ntawm ziab Tsawg dua lossis sib npaug li 7.0%; Residue ntawm ignition 19.0% -23.0% (sulfate cov ntsiab lus); Cov hlau hnyav (Pb Tsawg dua lossis sib npaug ntawm 10ppm, Hg Tsawg dua lossis sib npaug rau 1ppm, Cd Tsawg dua lossis sib npaug li 1ppm); Endotoxin Tsawg dua lossis sib npaug rau 0.3 EU / mg (rau kev siv tshuaj txhaj) |
| Melting Point | >250℃(nrog decomposition) |
| Solubility | Dawb soluble hauv dej (Ntau dua lossis sib npaug ntawm 500 g / L ntawm 25 degree); me ntsis soluble hauv methanol; Xyaum insoluble hauv ethanol, acetone, chloroform |
| Kev cia khoom | Khaws rau hauv qhov txias (15-25 degree), qhuav, lub teeb -cov thawv tiv thaiv; Sealed los tiv thaiv kev nqus dej (hygroscopic) thiab degradation; Tsis txhob sib cuag nrog cov acids muaj zog / bases; Lub neej txee: 36 lub hlis rau qib kws kho mob, 24 lub hlis rau qib kws kho tsiaj |
Core Functions & Mechanism of Action
CAS Nr .: 39831-55-5 exerts abactericidal nyhuvlos ntawm kev tsom mus rau cov kab mob ribosome- cuam tshuam nrog kev tsim cov protein, uas yog qhov tseem ceeb rau cov kab mob loj hlob thiab ciaj sia:
Ribosome Binding: Amikacin khi irreversibly rau 30S subunit ntawm cov kab mob ribosome, tshwj xeeb tshaj yog tsom rau 16S rRNA.
Protein Synthesis cuam tshuam: Qhov kev khi no thaiv ob kauj ruam tseem ceeb:
Kev pib ntawm cov protein synthesis (tiv thaiv kev tsim ntawm ribosome-mRNA-tRNA complex).
Kev ua pov thawj ntawm cov proteins uas tau tsim tawm tshiab (ua rau kev tsim cov khoom tsis yog- ua haujlwm, cov proteins muaj kuab lom).
Kab mob tuag: Sib sau ua ke ntawm cov uas tsis yog -cov proteins ua haujlwm thiab cuam tshuam ntawm daim nyias nyias ua rau cov kab mob cell lysis.
Cov txiaj ntsig tseem ceeb ntawm amikacin dua lwm cov aminoglycosides:
Kev Tiv Thaiv Kev Tiv Thaiv: Kev hloov kho rau nws cov qauv tshuaj (ntxiv rau 4-amino-2-hydroxybutanoyl sab saw) ua rau nws resistant rau feem ntau aminoglycoside-modifying enzymes (AMEs) - lub ntsiab mechanism ntawm aminoglycoside kuj nyob rau hauv Gram-negative kab mob.
Broad Gram -Negative Spectrum: Active tiv thaivPseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli, thiabEnterobacterspp.
Cov ntawv thov tseem ceeb
Amikacin Sulfate CAS #39831-55-5 yog tshwj tseg rauhnyav, lub neej- hem kab mob kab mob(feem ntau hauv cov neeg mob pw hauv tsev kho mob) qhov twg lwm cov tshuaj tua kab mob tsis zoo lossis contraindicated. Nws raug tswj hwm los ntawm parenterally (IV lossis IM) vim qhov nqus ntawm qhov ncauj tsis zoo.
1. Human Pharmaceutical Field
1.1 Gram hnyav-Cov kab mob tsis zoo
Tsev Kho Mob-Tshuaj Pneumonia (HAP) & Lub Cuab Yeej-Associated Pneumonia (VAP): Kho cov kab mob tshwm sim los ntawm ntau yam tshuaj -resistantPseudomonas aeruginosalos yogAcinetobacter baumannii. IV koob tshuaj: 15–20 mg / kg / hnub (ib koob tshuaj ib hnub lossis muab faib ua 2 koob) rau 7–14 hnub, kho rau lub raum ua haujlwm.
Septicemia & Bacteremia: Rau cov kab mob ntshav los ntawm CRE lossis ESBL- tsim tawmKlebsiella pneumoniae / E. coli. koob tshuaj IV: 15–20 mg/kg/hnub rau 10–14 hnub, feem ntau ua ke nrog ib tug -lactam tshuaj tua kab mob (synergistic effect).
Complexed Urinary Tract Infections (cUTIs): Kho cUTIs tiv taus lwm yam tshuaj tua kab mob (xws li fluoroquinolones). koob tshuaj IV/IM: 15 mg/kg/hnub rau 7-10 hnub.
1.2 Lwm yam kab mob
Cov kab mob ntawm daim tawv nqaij thiab mos mos (SSTIs): Rau SSTIs hnyav (piv txwv li, necrotizing fasciitis) tshwm sim los ntawm multidrug-tiv taus Gram- cov kab mob tsis zoo. IV koob tshuaj: 15-20 mg / kg / hnub rau 10-14 hnub, ua ke nrog kev phais mob.
Cov pob txha & pob qij txha: Kho osteomyelitis lossis septic mob caj dab tshwm sim los ntawmPseudomonas aeruginosa. IV koob: 15-20 mg / kg / hnub rau 4-6 lub lis piam.
2. Veterinary Field (Tshuaj Tsiaj & Tsiaj Tsiaj Tsiaj)
Amikacin Sulfate CAS #39831-55-5 yog siv hauvnyuj, npua, dev, thiab mivrau kev kho mob hnyav Gram- kis tsis zoo, feem ntau thaum lwm cov tshuaj tua kab mob tsis ua haujlwm:
Bovine Respiratory Disease (BRD): Ua los ntawm multidrug-resistantMannheimia hemolyticalos yogPasteurella multocida. IM koob tshuaj: 7.5-10 mg / kg lub cev hnyav ib hnub ib zaug rau 3-5 hnub.
Porcine Septicemia: RauE. colilos yogSalmonella-induced septicemia hauv piglets. koob tshuaj IM: 10-15 mg / kg ib hnub ib zaug rau 3-5 hnub.
Canine/Feline Urinary Tract & Kab Mob ntawm daim tawv nqaij: Rau resistantE. coli(UTIs) lubPseudomonas aeruginosa(cov kab mob ntawm daim tawv nqaij). koob tshuaj IM: 5-10 mg / kg ob zaug ib hnub rau 7-14 hnub.
Contraindications: Tsis txhob siv rau hauv cov menyuam yaus (kev pheej hmoo nephrotoxicity) lossis cov tsiaj uas muaj ua ntej - lub raum tsis zoo; tsis pom zoo rau cov nqaij qaib los yog cov nyuj noj (cov khoom seem thiab cov toxicity txaus ntshai).
Quality & Safety Assurance
Raws li ib qho tseem ceeb "kawg- kab" tshuaj tua kab mob, CAS #39831-55-5 yuav tsum muaj kev tswj xyuas nruj kom ntseeg tau tias muaj zog, purity, thiab kev nyab xeeb-tshwj xeeb tshaj yog muab nws qhov ntsuas nqaim (kev pheej hmoo ntawm nephrotoxicity thiab ototoxicity):
1. Kev tsim khoom & Purity Control
Synthesis: Ua los ntawm semi-synthetic hloov kho ntawm kanamycin A (acylation nrog 4-amino-2-hydroxybutyric acid), ua raws li sulfation thiab purification ntawm ion-exchange chromatography. Cov txheej txheem kom ntseeg tau tias:
Tsawg impurities (piv txwv li, kanamycin A, cov khoom degradation) Tsawg dua lossis sib npaug li 2.0%;
Cov ntsiab lus sulfate zoo ib yam (19.0% - 23.0%), tseem ceeb rau kev muaj zog sib xws.
Ua raws li GMP: Ua nyob rau hauv Qib C/D cleanrooms (raws li ICH Q7 cov lus qhia) rau txhaj tshuaj - cov khoom qib, nrog rau kev tswj nruj heev ntawm endotoxin qib (tsawg dua los yog sib npaug rau 0.3 EU/mg) kom tsis txhob muaj kab mob sepsis.
2. Cov Txheej Txheem Kev Ntsuas Zoo
| Cov khoom kuaj | Txoj kev | Kev lees txais |
|---|---|---|
| Purity & Assay | HPLC (C18 kem, 205nm kuaj pom) | Purity Ntau dua lossis sib npaug li 95.0%; Assay 690–770 ug/mg (anhydrous, sulfate-dawb) |
| Yam khoom muaj feem | HPLC (gradient elution) | Kanamycin A Tsawg dua lossis sib npaug li 1.0%; Tag nrho impurities Tsawg dua lossis sib npaug li 2.0% |
| Endotoxin (Kev txhaj tshuaj qib) | LAL (limulus Amebocyte Lysate) Test | Tsawg dua lossis sib npaug li 0.3 EU / mg |
| Hnyav Hlau | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb Tsawg dua lossis sib npaug rau 10ppm, Hg Tsawg dua lossis sib npaug rau 1ppm, Cd Tsawg dua lossis sib npaug rau 1ppm |
| Solubility & Clarity | Gravimetric txoj kev (dej, 25 degree) | Ntau dua lossis sib npaug li 500 g / L solubility; Clear daws (tsis muaj turbidity) |
| Poob rau ziab | Gravimetric method (105℃rau 3 teev) | Tsawg dua lossis sib npaug li 7.0% |
3. Kev ceeb toom kev nyab xeeb
Tib neeg siv:
Contraindications: hypersensitivity rau aminoglycosides; mob raum tsis zoo (CrCl<30 mL/min); pre-existing hearing loss or tinnitus (ototoxicity risk).
Cov teebmeem tsis zoo: Dose-dependent nephrotoxicity (saib ntshav creatinine, BUN) thiab ototoxicity (saib lub rooj sib hais / vestibular muaj nuj nqi); Tsis tshua muaj tab sis loj: neuromuscular blockade (kev pheej hmoo ntawm kev nyuaj siab ua pa hauv cov neeg mob myasthenia gravis).
Therapeutic Drug Monitoring (TDM): Required for patients with renal impairment, prolonged therapy (>7 hnub), los yog koob tshuaj ntau heev- lub hom phiaj ncov siab tshaj 20–30 ug/mL, trough concentration<10 μg/mL.
Kev siv Veterinary:
Lub Sijhawm rho nyiaj: Nyuj: 28 hnub (nqaij); Npua: 21 hnub (nqaij); Dogs/Cat: Tsis muaj lub sijhawm tshem tawm (tsis yog-cov tsiaj noj).
Residue ceeb toom: Txwv tsis pub nyob rau hauv cov nyuj thiab nteg qe -cov seem nyob rau hauv cov mis nyuj / qe ua rau tib neeg noj qab haus huv.
Kev koom tes & kev sib cuag
Peb muab Amikacin Sulfate nyob rau hauv cov qib uas haum rau txhaj tshuaj rau tib neeg thiab tsiaj txhu:
Pharmaceutical Qib: Cov hmoov zoo rau IV / IM formulations (1kg-100kg ib qho kev txiav txim, ntim cov hnab ntawv txhuas nrog cov desiccants).
Veterinary Qib: Hmoov rau tsiaj txhu / khub tsiaj txhaj tshuaj (10kg-500kg ib qho kev txiav txim; txhua hli muaj peev xwm ntawm 1500kg).
Tus nqi - cov kev pabcuam ntxiv suav nrog:
Muab DMF (Drug Master File) thiab CEP (Certificate of Suitability) rau cov kws tshuaj -qib cov khoom los txhawb EU/US/Asia rau npe.
Kev txhawb nqa rau TDM raws tu qauv (tib neeg siv) thiab kev ntsuam xyuas kev ruaj ntseg ntawm kws kho tsiaj.
Batch- tshwj xeeb COA nrog endotoxin, purity, thiab kev soj ntsuam cov txiaj ntsig kom ua tau raws li.
Yog tias koj yog cov chaw tsim tshuaj, tus neeg muag khoom hauv tsev kho mob, lossis kev lag luam tshuaj veterinary, thov hu rau peb kom paub meej kev koom tes:
Cov ntaub ntawv tiv tauj:
Email: sales@huarongpharma.com
Xov tooj/WhatsApp: +86 13751168070
Peb ua raws li cov hauv paus ntsiab lus ntawm "kawg- kab zoo, kev tswj hwm kev tiv thaiv, thiab kev nyab xeeb ntawm tus neeg mob / tsiaj txhu" thiab tos ntsoov yuav koom tes nrog kev lag luam thoob ntiaj teb kev noj qab haus huv thiab tsiaj kev noj qab haus huv!
Cim npe nrov: Amikacin sulfate cas #39831-55-5, Tuam Tshoj amikacin sulfate cas #39831-55-5 manufacturers, lwm tus neeg
