Sulbactam Sodium (CAS No.: 69388-84-7) - -Lactamase Inhibitor rau Enhancing Penicillin / Cephalosporin Efficacy
Raws li tus kws tshaj lij ntawm kev lag luam tshuaj - qib tshuaj tua kab mob adjuvant active cov khoom xyaw, peb muab siab - purity Sulbactam Sodium uas nruj me ntsis ua raws li lub ntiaj teb no pharmacopoeia cov qauv (USP, EP, BP, CP). Ib tug hluavtaws -lactamase inhibitor, nws tsis muaj lub ntsiab lus tseem ceeb hauv cov tshuaj tua kab mob tab sis ua lub luag haujlwm tseem ceeb hauvrov kho qhov ua tau zoo ntawm -lactam tshuaj tua kab mob(piv txwv li, ampicillin, cefoperazone) tawm tsam tshuaj - cov kab mob resistant. Los ntawm irreversibly inhibiting kab mob -lactamase enzymes (uas ua rau - tshuaj tua kab mob lactam), nws nthuav cov spectrum ntawm cov tshuaj tua kab mob no kom muaj xws li -lactam- hom kab mob resistant- ua rau nws yog ib feem tseem ceeb ntawm kev sib ntaus sib tua multidrug - kab mob resistanttib neeg tshuajthiab xaivkev xyaum ua tsiaj.
Product Basic Information
| Yam khoom | Paub meej |
|---|---|
| Khoom npe | Sulbactam Sodium |
| CAS Nr. | 69388-84-7 |
| Synonyms | (2S,5R)-3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide sodium ntsev; - Lactamase inhibitor adjuvant |
| Molecular Formula | C₈H₁₀NaO₅S |
| Molecular Luj | 255.22 |
| Qhov tshwm sim | Dawb rau tawm -dawb crystalline hmoov; Tsis muaj ntxhiab los yog nrog me ntsis cov yam ntxwv tsw |
| Specification | - Pharmaceutical Qib: Purity Ntau dua lossis sib npaug li 98.0% (HPLC); Assay (as sulbactam) 97.0%–103.0%; Kev sib hloov kho qhov muag tshwj xeeb [ ]²⁰D +223℃rau +237℃(hauv dej, c=1); Poob ntawm ziab Tsawg dua lossis sib npaug li 1.0%; Residue ntawm ignition 18.0% -20.0% (sodium 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); Cov kuab tshuaj seem (ethanol Tsawg dua lossis sib npaug rau 500ppm, acetone Tsawg dua lossis sib npaug rau 500ppm) |
| Melting Point | 196-200℃(nrog decomposition) |
| Solubility | Dawb soluble hauv dej (Ntau dua lossis sib npaug ntawm 200 g / L ntawm 25 degree); Soluble hauv methanol, ethanol; me ntsis soluble hauv acetone; Insoluble hauv chloroform, ether |
| Kev cia khoom | Khaws rau hauv qhov txias (15-25 degree), qhuav, lub teeb -cov thawv tiv thaiv; Muab kaw kom tiv thaiv kom tsis txhob ya raws thiab hydrolysis (-lactam nplhaib yog noo noo-sensitive); 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
Cov kab mob tsis kam mus rau -lactam tshuaj tua kab mob (xws li penicillins, cephalosporins) feem ntau tshwm sim los ntawm kev tsim cov-lactamase enzymes-cov enzymes no tshem tawm -lactam nplhaib ntawm cov tshuaj tua kab mob, ua rau lawv tsis ua haujlwm. Sulbactam Sodium hais txog qhov kev tawm tsam no los ntawm kev ua raws li asuicide inhibitorntawm -lactamases:
Irreversible khi: Sulbactam's -lactam ring binds covalently to the active site of -lactamase enzymes (tshwj xeeb yog Class A enzymes, eg, penicillinase, TEM, SHV).
Enzyme Inactivation: Qhov kev khi no tsim ib qho chaw ruaj khov, tsis muaj zog, mus tas li thaiv cov enzyme los ntawm degrading co- tswj hwm -lactam tshuaj tua kab mob.
Kev nthuav dav Spectrum: Los ntawm inhibiting -lactamases, Sulbactam rov ua haujlwm ntawm -lactam tshuaj tua kab mob tiv thaiv kab mob uas yuav tiv taus (xws li, -lactam-resistantStaphylococcus aureus, Hemophilus influenzae, Escherichia coli).
Qhov tseem ceeb, Sulbactam muaj zog tiv thaiv kab mob hauv nruab nrog tsuas yog tawm tsamNeisseria gonorrhoeae: kev kho mobthiabHemophilus influenzae-nws tus nqi kho mob yuav luag tag nrho hauv nws lub luag haujlwm adjuvant nrog -lactam tshuaj tua kab mob.
Cov ntawv thov tseem ceeb (Human & Veterinary Medicine)
Sulbactam Sodium CAS 69388-84-7 yogyeej tsis siv ib leeg; nws yeej ib txwm ua ke nrog -lactam tshuaj tua kab mob nyob rau hauv taag- koob tshuaj formulations los kho -lactam- cov kab mob resistant.
1. Human Pharmaceutical Field
Feem ntau ua ke nrog ampicillin, cefoperazone, lossis piperacillin, nrog rau kev sib xyaw ua ke feem ntau yogAmpicillin -Sulbactam(1: 1 lossis 2: 1 ratio) thiabCefoperazone-Sulbactam(1: 1 ratio).
1.1 Kab mob ua pa
Zej Zog -Tau mob ntsws (CAP): Kho CAP tshwm sim los ntawm -lactam-resistantStreptococcus pneumoniae, Hemophilus influenzae, los yogMoraxella catarrhalis. IV/oral dose (Ampicillin-Sulbactam): 1.5–3 g txhua 6 teev rau 7–14 hnub.
Chronic Bronchitis Exacerbation: Rau cov kab mob tsis teb rau ib leeg -tus neeg sawv cev -lactams. koob tshuaj IV (Cefoperazone-Sulbactam): 2–4 g txhua 12 teev rau 5–7 hnub.
1.2 Daim tawv nqaij & Cov ntaub so ntswg mos
Cellulitis, Abscesses: Kho cov kab mob tshwm sim los ntawm -lactam-resistantStaphylococcus aureus(MSSA) lubStreptococcus pyogenes muaj. IV/qhov ncauj koob tshuaj (Ampicillin-Sulbactam): 1.5–3 g txhua 6 teev rau 7–10 hnub, ua ke nrog kev phais mob yog tias xav tau.
1.3 Intra- Kab mob plab & Pelvic
Peritonitis, cholecystitis: Tiv thaiv cov kab mob sib xyaw ua ke (aerobic + anaerobic) nrog -lactam- resistant hom (xws li,E. coli, Bacteroides fragilis). IV koob tshuaj (Piperacillin-Sulbactam): 3.375 g txhua 6 teev rau 10-14 hnub.
Pelvic Inflammatory Disease (PID): Kho PID tshwm sim los ntawm -lactam-resistantNeisseria gonorrhoeae: kev kho moblos yogChlamydia trachomatis. koob tshuaj IV (Ampicillin-Sulbactam): 3 g txhua 6 teev, ua ke nrog doxycycline.
1.4 Urinary Tract Infections (UTIs)
Complicated UTIs: Rau -lactam-resistantE. colilos yogKlebsiella pneumoniae. IV/oral dose (Ampicillin-Sulbactam): 1.5–3 g txhua 6 teev rau 7–14 hnub.
2. Veterinary Field (Tshuaj Tsiaj & Tsiaj Tsiaj Tsiaj)
Sulbactam Sodium CAS#69388-84-7 yog siv ua ke nrog ampicillin lossis amoxicillin rau kev kho cov kab mob hauv cov kab mob.nyuj, npua, thiab dev(tsis txhob siv rau hauv cov nqaij qaib vim muaj kev pheej hmoo ntawm residue):
Bovine Respiratory Disease (BRD): Ua los ntawm -lactam-resistantMannheimia hemolyticalos yogPasteurella multocida. Kev txhaj tshuaj (Ampicillin-Sulbactam): 15–20 mg/kg (raws li qhov hnyav ua ke) ib hnub ib zaug rau 3–5 hnub.
Porcine Respiratory Disease Complex (PRDC): Rau -lactam-resistantActinobacillus pleuropneumoniae yog cov kab mob. Kev txhaj tshuaj / qhov ncauj (Amoxicillin-Sulbactam): 10–15 mg / kg ib hnub ib zaug rau 5-7 hnub.
Kab mob ntawm Canine (Pyoderma): Ua los ntawm -lactam-resistantStaphylococcus pseudintermediaus. koob tshuaj qhov ncauj (Amoxicillin-Sulbactam): 12.5–25 mg/kg ob zaug ib hnub rau 7–14 hnub.
Quality & Safety Assurance
Raws li ib qho tseem ceeb adjuvant rau -lactam tshuaj tua kab mob, CAS#69388-84-7 yuav tsum muaj kev tswj xyuas nruj kom ntseeg tau tias inhibitor kev ua, kev ruaj ntseg, thiab kev nyab xeeb:
1. Kev tsim khoom & Purity Control
Synthesis: Ua los ntawm semi- hluavtaws hloov kho ntawm penicillin G (ntawm oxidation, nplhaib expansion, thiab ntsev tsim nrog sodium hydroxide). Cov txheej txheem yog optimized rau:
Khaws lub -lactam nplhaib (tseem ceeb rau kev ua haujlwm inhibitor);
Txo cov impurities (piv txwv li, penicillin derivatives, oxidation byproducts) kom tsawg dua los yog sib npaug li 0.5%.
Ua raws li GMP: Ua nyob rau hauv Qib C / D cleanrooms (raws li ICH Q7 cov lus qhia) rau qib tshuaj, nrog kev tswj nruj ntawm cov dej noo (kom tiv thaiv -lactam ring hydrolysis) thaum lub sij hawm tsim khoom thiab ntim khoom.
2. Cov Txheej Txheem Kev Ntsuas Zoo
| Cov khoom kuaj | Txoj kev | Kev lees txais |
|---|---|---|
| Purity & Assay | HPLC (C18 kem, 220nm kuaj pom) | Purity Ntau dua lossis sib npaug li 98.0%; Assay 97.0% – 103.0% (raws li sulbactam) |
| -Lactamase Inhibitor Activity | Kev soj ntsuam microbiological (siv -lactam-} tiv tausS. aureus) | Restores ampicillin kev ua ub no rau resistant hom (zone of inhibition Ntau tshaj los yog sib npaug rau 15 mm) |
| Yam khoom muaj feem | HPLC (gradient elution) | Ib qho impurity Tsawg dua lossis sib npaug li 0.2%; Tag nrho impurities Tsawg dua lossis sib npaug li 0.5% |
| 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 |
| Residual Solvents | GC (headspace sampling, FID ntes) | Chav kawm 2 cov kuab tshuaj tsawg dua lossis sib npaug ntawm 500ppm; Cov kuab tshuaj Class 1 tsis kuaj |
| Sterility (Tshwj xeeb txhaj tshuaj) | Membrane filtration method | Tsis muaj kab mob / fungal loj hlob |
3. Kev ceeb toom kev nyab xeeb
Tib neeg siv:
Contraindications: Hypersensitivity rau sulbactam, penicillins, lossis cephalosporins (cross-kev pheej hmoo ua xua); mob raum tsis zoo (CrCl<30 mL/min-dose reduction required).
Cov teebmeem tsis zoo: Feem ntau: xeev siab, raws plab, pob khaus. Tsis tshua muaj tab sis hnyav: cov tshuaj tiv thaiv anaphylactic (saib rau hawb pob, hypotension), siab enzyme siab, thiab hematologic abnormalities (xws li leukopenia).
Kev siv Veterinary:
Lub Sijhawm rho nyiaj: nyuj: 14 hnub (nqaij), 48 teev (mis nyuj); Npua: 7 hnub (nqaij); Cov dev: Tsis muaj lub sijhawm tshem tawm (tsis yog- tsiaj txhu noj).
Residue ceeb toom: Tsis txhob siv rau hauv cov hens lossis nyuj cov mis nyuj tshaj lub sijhawm tshem tawm kom tsis txhob muaj tshuaj tua kab mob hauv cov qe/mis nyuj.
Kev koom tes & kev sib cuag
Peb muab Sulbactam Sodium nyob rau hauv formulations tailored mus ua ke tshuaj raug tsim:
Pharmaceutical Qib: Cov hmoov zoo rau kev txhaj tshuaj / qhov ncauj ruaj khov- kev sib xyaw ua ke (1kg–100kg ib qho kev txiav txim, ntim cov hnab ntim aluminium ntawv ci nrog desiccants).
Veterinary Qib: Hmoov rau tsiaj txhu txhaj tshuaj / qhov ncauj premixes (10kg-500kg ib qho kev txiav txim; txhua hli muaj peev xwm ntawm 2000kg).
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 kev txhim kho - koob tshuaj sib xyaw ua ke (piv txwv li, kev ua kom zoo ntawm ampicillin-sulbactam piv, ua kom muaj kev ruaj ntseg).
Inhibitor activator testing (microbiological assays) kom siv tau cov kev ua tau zoo tiv thaiv -lactam- cov kab mob resistant.
Yog tias koj yog cov chaw tsim tshuaj, lub tuam txhab tshuaj generic, 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
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Peb ua raws li cov hauv paus ntsiab lus ntawm "kev ua tau zoo, kev tswj hwm kev tiv thaiv, thiab kev ua tau zoo tshaj plaws" thiab tos ntsoov rau kev koom tes nrog kev lag luam kev noj qab haus huv thoob ntiaj teb thiab tsiaj txhu kev lag luam!
Cim npe nrov: Sulbactam Sodium CAS #69388-84-7, Tuam Tshoj Sulbactam Sodium CAS #69388-84-7 manufacturers, lwm tus neeg
