Azithromycin (CAS No.: 83905-01-5) - Broad-Spectrum Macrolide Antibacterial for Respiratory, Skin & STI Infections
Raws li tus kws tshaj lij ntawm cov kws kho mob - qib thiab kws kho tsiaj - qib tshuaj tua kab mob cov khoom xyaw, peb muab siab - purity Azithromycin uas nruj me ntsis ua raws li cov qauv tshuaj tshuaj thoob ntiaj teb (USP, EP, BP, CP). Ib tug thib ob - tiam ib nrab- cov tshuaj tua kab mob macrolide uas tau muab los ntawm erythromycin, nws muaj peev xwm ua kom muaj zog, qhov dav dav, thiab ib qho tshwj xeeb ib zaug-txhua hnub, luv- chav kawm noj tshuaj. Nws yog dav siv nyob rau hauvtib neeg tshuajrau kev kho mob ua pa, tawv nqaij, thiab kis tau tus kab mob sib deev (STIs)-tshwj xeeb tshaj yog nyob rau hauv cov neeg mob uas tsis zoo ua raws li lub sij hawm ntev - kho lub sij hawm- thiab nyob rau hauvkev xyaum ua tsiajrau cov tsiaj nyeg thiab cov tsiaj sib raug zoo, ua tus neeg sawv cev tseem ceeb tiv thaiv yeeb tshuaj -tiv taus Gram- cov kab mob zoo thiab atypical.
Product Basic Information
| Yam khoom | Paub meej |
|---|---|
| Khoom npe | Azithromycin |
| CAS Nr. | 83905-01-5 |
| Synonyms | (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy- }3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-2-ethyl-3, 4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- -}D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one |
| Molecular Formula | C₃₈H₇₂N₂O₁₂ |
| Molecular Luj | 748.98 |
| 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 950-1050 ug / mg (anhydrous hauv paus); Poob ntawm ziab Tsawg dua lossis sib npaug li 2.0%; Cov hlau hnyav (Pb Tsawg dua lossis sib npaug ntawm 5ppm, Hg Tsawg dua lossis sib npaug rau 1ppm, Cd Tsawg dua lossis sib npaug li 1ppm); Cov kuab tshuaj seem (methanol Tsawg dua lossis sib npaug rau 300ppm, acetone Tsawg dua lossis sib npaug li 500ppm)-Veterinary Qib: Purity Ntau dua lossis sib npaug li 95.0% (HPLC); Assay 900–1100 ug/mg; Cov hlau hnyav tsawg dua lossis sib npaug li 10ppm |
| Melting Point | 113-115℃(nrog me ntsis decomposition) |
| Solubility | Xyaum insoluble hauv dej (≈0.25 g / L ntawm 25 degree); Soluble hauv methanol (≈100 g / L), ethanol (≈50 g / L), chloroform (≈200 g / L); Me ntsis soluble hauv acetone |
| 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 thiab degradation (ruaj khov nyob rau hauv nruab nrab pH, rhiab heev rau cov kua qaub / alkali); Tsis txhob sib cuag nrog oxidizing agents; Lub neej txee: 36 lub hlis rau qib kws kho mob, 24 lub hlis rau qib kws kho tsiaj |
Core Functions & Mechanism of Action
Azithromycin exerts ibbacteriostatic nyhuv(Cov kab mob tua kab mob ntawm cov koob tshuaj siab tiv thaiv kab mob uas raug mob) los ntawm kev tsom mus rau cov kab mob ribosome, cuam tshuam cov protein synthesis- nrog cov txiaj ntsig tseem ceeb tshaj thawj - tiam macrolides (xws li erythromycin):
Ribosome Binding: Azithromycin khi reversibly rau 50S subunit ntawm cov kab mob ribosome (tshwj xeeb yog 23S rRNA), nrog 10-100 npaug ntau dua affinity dua erythromycin. Qhov kev khi no thaiv cov kauj ruam hloov pauv ntawm cov protein synthesis, nres peptide saw elongation.
Unique Pharmacokinetics: Nws nthuav tawmconcentration- nyob ntawm kev ua haujlwmthiab ntev ib nrab-lub neej (~68 teev), tso cai rau ib zaug- noj txhua hnub thiab kev kawm luv luv (3-5 hnub). Nws kuj tseem khaws cov leukocytes thiab cov ntaub so ntswg (piv txwv li, ntsws, tawv nqaij, qhov chaw mos) ntawm qhov siab ntawm 10-100 npaug ntau dua li cov ntshav plasma{10}} tseem ceeb rau kev kho cov kab mob hauv lub cev.
Broad Spectrum:
Gram -zoo: Active tiv thaivStaphylococcus aureus(MSSA),Streptococcus pneumoniae(suav nrog qee cov macrolide-sensitive hom), thiabStreptococcus pyogenes muaj.
Gram -tsis zoo: InhibitsHemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae: kev kho mob, thiabNeisseria meningitidis.
Cov kab mob Atypical: Zoo heev tiv thaiv cov kab mob intracellular zoo liMycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydia trachomatis, thiabLegionella pneumophila.
Cov ntawv thov tseem ceeb
Azithromycin yog siv rau qhov ncauj (ntsiav tshuaj, tshuaj ntsiav, ncua kev kawm) los yog intravenously (IV) rau mob hnyav; Qhov ncauj formulations nyiam vim zoo heev bioavailability (~ 37%) thiab tolerability. Nws tsis muaj zog tiv thaiv kab mob (piv txwv li, mob khaub thuas / mob khaub thuas) lossis Gram- cov pas nrig tsis zoo (xws li,E. coli, Klebsiella).
1. Human Pharmaceutical Field
1.1 Kab mob ua pa
Zej Zog -Tau mob ntsws (CAP): Thawj - kab kev kho rau CAP tshwm sim los ntawmMycoplasma pneumoniae, Chlamydophila pneumoniae, los yogHemophilus influenzae. koob tshuaj ntawm qhov ncauj: 500 mg rau Hnub 1, tom qab ntawd 250 mg ib hnub ib hnub rau Hnub 2-5 (tag nrho 1.5 g); koob tshuaj IV: 500 mg ib hnub ib zaug rau 2-3 hnub, ces hloov mus rau qhov ncauj.
Mob pharyngitis / tonsillitis: RauStreptococcus pyogenes muajkab mob (lwm yam rau penicillin). koob tshuaj qhov ncauj: 500 mg ib hnub ib zaug rau 3 hnub (los yog 1.5 g ib koob tshuaj hauv qee thaj tsam).
Mob Bronchitis Exacerbation: Kho cov kab mob superinfection hauv cov neeg mob COPD. Qhov ncauj koob tshuaj: 500 mg rau Hnub 1, 250 mg Hnub 2–5.
1.2 Daim tawv nqaij & Cov ntaub so ntswg mos
Cellulitis & Impetigo: RauStaphylococcus aureus(MSSA) lubStreptococcus pyogenes muajkab mob. Qhov ncauj koob tshuaj: 500 mg Hnub 1, 250 mg Hnub 2–5 (los yog 1 g ib lub lim tiam rau 2 lub lis piam rau cov mob hnyav).
Folliculitis: Tshuaj pleev ib ce (1% gel) rau cov mob me; koob tshuaj qhov ncauj rau kev kis kab mob.
1.3 Kev sib deev kis kab mob (STIs)
Kab mob Chlamydia Trachomatis: Thawj- kab kev kho rau urethritis, cervicitis, lossis pelvic inflammatory disease (PID). koob tshuaj qhov ncauj: 1 g ib koob tshuaj (siab ua raws li ib qho - lub sijhawm tswj hwm).
Gonorrhea: Alternative therapy forNeisseria gonorrhoeae: kev kho mob(ua ke nrog ceftriaxone rau kev sib ntaus sib tua). Qhov ncauj koob tshuaj: 1 g ib koob + ceftriaxone 250 mg IM.
Syphilis: Thib ob- kab kev kho mob rau cov mob syphilis thaum ntxov (penicillin- cov neeg mob tsis haum). Qhov ncauj koob tshuaj: 500 mg ob zaug ib hnub rau 14 hnub.
1.4 Lwm yam kab mob
Legionnaires Tus Kab Mob: Siv tau tawm tsamLegionella pneumophila. IV / qhov ncauj koob tshuaj: 500 mg ib hnub ib zaug rau 10-14 hnub.
Mycobacterium Avium Complex (MAC): Prophylaxis thiab kev kho mob rau MAC hauv cov neeg mob immunocompromised (piv txwv li, HIV- zoo). Qhov ncauj koob tshuaj: 1.2 g ib lub lim tiam.
2. Veterinary Field (Tshuaj Tsiaj & Tsiaj Tsiaj Tsiaj)
Azithromycin yog siv los kho cov kab mob hauv cov kab mobnyuj, npua, qaib, dev, thiab miv-tshwj xeeb tshaj yog rau cov kab mob hauv lub cev xws liMycoplasma:
Bovine Respiratory Disease (BRD): Ua los ntawmMycoplasma kab moblos yogMannheimia hemolytica. IM / qhov ncauj koob tshuaj: 10 mg / kg lub cev hnyav ib hnub ib zaug rau 3 hnub.
Porcine Respiratory Disease Complex (PRDC): RauMycoplasma hyopneumoniaelos yogActinobacillus pleuropneumoniae yog cov kab mob. Qhov ncauj koob tshuaj: 5-10 mg / kg ib hnub ib zaug rau 3-5 hnub.
Poultry Chronic Respiratory Disease (CRD): KhoMycoplasma gallisepticumhauv qaib. Qhov ncauj koob tshuaj: 10-20 mg / kg haus dej rau 3-5 hnub.
Canine/Feline daim tawv nqaij & pob ntseg kab mob: RauStaphylococcus pseudintermediaus(dawb) los yogMycoplasmaua spp. (pob ntseg). Qhov ncauj koob tshuaj: 5-10 mg / kg ib hnub ib zaug rau 5-7 hnub.
Contraindications: Zam tsis txhob siv nees (colitis txaus ntshai) lossis tsiaj uas muaj ua ntej- muaj kev puas siab puas ntsws; tsis pom zoo rau cov nyuj uas muaj mis nyuj ua mis nyuj rau tib neeg noj.
Quality & Safety Assurance
Raws li kev siv dav dav macrolide nrog cov kev mob tshwm sim tsawg, Azithromycin yuav tsum muaj kev tswj xyuas nruj kom ntseeg tau tias muaj zog, purity, thiab kev nyab xeeb-tshwj xeeb tshaj yog muaj kev tawm tsam hauv qee cov kab mob:
1. Kev tsim khoom & Purity Control
Ntau lawm: Ua los ntawm semi- hluavtaws hloov kho ntawm erythromycin (qhia txog methyl- hloov nitrogen rau hauv lub nplhaib macrolide), ua raws li kev ua kom huv (chromatography) thiab crystallization. Cov txheej txheem kom ntseeg tau tias:
Yam tsawg kawg nkaus impurities (piv txwv li, degradation khoom, ntsig txog macrolides) Tsawg dua los yog sib npaug rau 1.0% (qib tshuaj);
Kev muaj peev xwm sib xws (950-1050 ug / mg) rau cov txiaj ntsig kho tau zoo.
Ua raws li GMP: Pharmaceutical-qib Azithromycin yog tsim nyob rau hauv Qib D cleanrooms (raws li ICH Q7 cov lus qhia); Veterinary qib ua raws li GMP rau tsiaj tshuaj.
2. Cov Txheej Txheem Kev Ntsuas Zoo
| Cov khoom kuaj | Txoj kev | Kev lees txais |
|---|---|---|
| Purity & Assay | HPLC (C18 kem, 210nm kuaj pom) | Pharmaceutical qib: Ntau dua lossis sib npaug rau 98.0% purity; Assay 950–1050 ug/mg |
| Yam khoom muaj feem | HPLC (gradient elution) | Ib qho impurity Tsawg dua lossis sib npaug li 0.5%; Tag nrho cov impurities Tsawg dua lossis sib npaug rau 1.0% (qib tshuaj) |
| Hnyav Hlau | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pharmaceutical qib: Pb Tsawg dua lossis sib npaug li 5ppm; Veterinary qib: Tsawg dua lossis sib npaug li 10ppm |
| 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 |
| Poob rau ziab | Gravimetric method (105℃rau 2 teev) | Tsawg dua lossis sib npaug li 2.0% (qib tshuaj) |
| Kev txheeb xyuas | IR Spectroscopy & HPLC Retention Time | Sib tw siv tus qauv spectrum; Lub sijhawm khaws cia raws li tus qauv |
3. Kev ceeb toom kev nyab xeeb
Tib neeg siv:
Contraindications: Hypersensitivity rau macrolides tshuaj tua kab mob; keeb kwm ntawm QT ncua ncua sij hawm (tsis txhob nrog cov tshuaj tiv thaiv zoo li sotalol); mob siab heev.
Cov teebmeem tsis zoo: Mob me me thiab tsis tshua muaj: mob plab hnyuv (xws li xeev siab, raws plab), mob taub hau, thiab pob liab liab; Tsis tshua muaj tab sis hnyav: hepatotoxicity (rov qab los ntawm kev txiav tawm) thiab torsades de pointes (hauv cov neeg mob uas muaj qhov txawv txav ntawm electrolyte).
Cov tshuaj sib cuam tshuam: Tsawg tsawg piv rau erythromycin (tsis muaj zog CYP3A4 inhibitor); zam kev siv nrog digoxin (nce qib hauv cov ntshav digoxin) lossis warfarin (saib INR).
Kev siv Veterinary:
Lub Sijhawm rho nyiaj: Nyuj: 28 hnub (nqaij); Npua: 14 hnub (nqaij); Nqaij qaib: 7 hnub (nqaij / qe); Dogs/Cat: Tsis muaj lub sijhawm tshem tawm (tsis yog-cov tsiaj noj).
Residue ceeb toom: Txwv tsis pub noj cov nyuj (cov kua mis seem) thiab nteg qe (qe residues) dhau lub sijhawm tshem tawm.
Kev koom tes & kev sib cuag
Peb muab Azithromycin hauv qib thiab cov ntaub ntawv raws li kev siv tib neeg thiab tsiaj txhu:
Pharmaceutical Qib: Cov hmoov zoo los yog zaj duab xis-coated granules (1kg-100kg ib qho kev txiav txim, kaw lub hnab aluminium foil nrog desiccants) rau qhov ncauj / IV formulations.
Veterinary Qib: Hmoov rau tsiaj txhu qhov ncauj premixes lossis txhaj tshuaj (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 cov menyuam yaus raug tshem tawm (kev txhim kho palatability) thiab kev ntsuam xyuas kev ruaj ntseg ntawm kws kho tsiaj.
Batch-COA tshwj xeeb nrog kev ua kom huv, kev soj ntsuam, thiab cov kuab tshuaj uas seem tshuav los xyuas kom muaj kev ua raws cai.
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:
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