Product Basic Information
| Yam khoom | Paub meej |
|---|---|
| Khoom npe | Ibuprofen |
| CAS Nr. | 15687-27-1 |
| Synonyms | (±)-2-(4-Isobutylphenyl) propanoic acid; Advil® / Motrin® (cov npe npe rau OTC formulations) |
| Molecular Formula | C₁₃H₁₈O₂ |
| Molecular Luj | 206.28 |
| Qhov tshwm sim | Dawb rau tawm -dawb crystalline hmoov; Tsis muaj ntxhiab, nrog me ntsis iab saj |
| Specification | - Pharmaceutical Qib: Purity Ntau dua lossis sib npaug li 99.0% (HPLC); Assay (raws li ibuprofen) Ntau dua lossis sib npaug rau 98.5%–101.5%; Melting point 74-77 degree; Poob ntawm ziab Tsawg dua lossis sib npaug li 0.5%; Cov hlau hnyav (Pb Tsawg dua lossis sib npaug rau 10ppm, Hg Tsawg dua lossis sib npaug rau 1ppm, Cd Tsawg dua lossis sib npaug rau 1ppm)-OTC/Food Qib: Purity Ntau dua lossis sib npaug li 98.0% (HPLC); Ua raws li FDA / EMA OTC monographs; Tsis pom muaj impurities (tsawg dua lossis sib npaug li 0.1%) |
| Melting Point | 74-77 degree |
| Solubility | Xyaum insoluble hauv dej (≈21 mg / L ntawm 25 degree); Soluble hauv ethanol, methanol, acetone, thiab dilute sodium hydroxide daws; Sparingly soluble hauv 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 thiab oxidation; Lub neej txee: 36 lub hlis rau qib tshuaj, 24 lub hlis rau qib OTC |
Core Functions & Applications
Ibuprofen Cas#15687-27-1exerts nws cov tshuaj pharmacological los ntawm inhibiting cyclooxygenase (COX) enzymes-tshwj xeeb yog COX-1 (kev koom ua ke, koom nrog hauv kev tiv thaiv plab hnyuv thiab platelet muaj nuj nqi) thiab COX-2 (inducible). Los ntawm thaiv COX, nws txo cov synthesis ntawm prostaglandins-lipid mediators uas ua rau mob, mob, thiab kub taub hau. Nws cov tshuaj tiv thaiv kab mob yog qhov tshwj xeeb tshaj yog rau cov mob uas muaj cov ntaub so ntswg o, thaum nws cov nyhuv analgesic tsom rau qhov mob me me mus rau nruab nrab. Nws yog feem ntau siv nyob rau hauvtib neeg tshuaj, nrog txwv kev siv cov tsiaj txhu:
1. Human Pharmaceutical & OTC Field
1.1 Pain Relief (Kev siv tshuaj loog)
Mob mob: Ua ntej - kab kev kho mob me me - rau - mob nruab nrab, suav nrog:
Mob taub hau ( mob taub hau, mob migraines): koob tshuaj qhov ncauj (200-400 mg txhua 4-6 teev, max 1200 mg / hnub rau cov neeg laus) kom txo qhov mob hnyav thiab ntev.
Qhov mob musculoskeletal (mob nraub qaum, mob caj dab, pob tw / hom): 400-600 mg txhua 6-8 teev (max 2400 mg / hnub) txhawm rau txo qhov mob thiab txhim kho kev txav mus los.
Mob tom qab phais: 400-800 mg txhua 6-8 teev (feem ntau ua ke nrog acetaminophen rau kev sib koom ua ke) kom txo tau kev siv tshuaj opioid.
Kev mob hniav (mob hniav, tom qab- mob tshem tawm): 200–400 mg txhua 4-6 teev, nrog qhov pib sai dua li acetaminophen.
1.2 Kev txo qis qis (Tshuaj tiv thaiv -Kev siv mob)
Cov mob mob ntev:
Osteoarthritis: 400–800 mg peb zaug ib hnub twg (max 2400 mg/hnub) kom txo tau cov mob pob qij txha, txhav, thiab o- txhim kho cov dej num txhua hnub (xws li taug kev, nce ntaiv).
Rheumatoid mob caj dab: 800 mg peb mus rau plaub zaug ib hnub twg (nyob rau hauv kev saib xyuas kev kho mob) txhawm rau txhawm rau txhawm rau cov kab mob synovial thiab qeeb kev sib koom ua ke.
Juvenile idiopathic arthritis (JIA): Pediatric koob tshuaj (5–10 mg/kg txhua 6–8 teev, max 40 mg/kg/hnub) los tswj qhov mob thiab mob rau cov menyuam yaus siab dua lossis sib npaug li 6 lub hlis.
1.3 Fever txo (Kev siv tshuaj tua kab mob)
Ua npaws: Pom zoo ua npaws rau cov neeg laus thiab menyuam yaus (Ntau dua lossis sib npaug li 6 lub hlis) cuam tshuam nrog kev kis kab mob (xws li mob khaub thuas, mob khaub thuas, kab mob bacterial infections):
Cov neeg laus: 200-400 mg txhua 4-6 teev (max 1200 mg / hnub) kom txog thaum kub taub hau.
Cov me nyuam: 5–10 mg/kg txhua 6–8 teev (max 40 mg/kg/hnub), muab tshuaj noj los yog ntsiav tshuaj zom tau yooj yim.
2. Veterinary Field (Cov Tsiaj Txhaum Cai)
Ibuprofen Cas #15687-27-1 istsis pom zoo rau miv(muaj kev pheej hmoo siab ntawm lub raum tsis ua haujlwm vim cov metabolism tsis zoo) tab sis qee zaus siv tawm -label hauvdevrau luv luv -kev tswj xyuas cov kab mob inflammatory, nyob rau hauv nruj veterinary saib xyuas:
Canine Osteoarthritis: 2–4 mg / kg lub cev hnyav ob zaug ib hnub (max 8 mg / kg / hnub) rau 5–7 hnub txhawm rau txo qhov mob pob qij txha thiab txhim kho kev txav mus los. Kev siv sijhawm ntev - raug zam vim muaj kev pheej hmoo rau lub raum/hepatic toxicity.
Postoperative Mob hauv dev: 2-4 mg / kg ob zaug ib hnub rau 3-5 hnub (ua ke nrog lwm cov tshuaj loog zoo li tramadol) kom txo tau qhov mob tom qab phais orthopedic lossis mos mos.
Contraindication: Tsis txhob siv rau hauv miv, cev xeeb tub / tus dev laus, lossis dev nrog ua ntej - kab mob hauv lub raum / kab mob siab, kab mob hauv plab, lossis los ntshav.
Quality & Safety Assurance
Raws li kev siv dav dav OTC thiab cov tshuaj noj, Ibuprofen yuav tsum muaj kev tswj xyuas nruj kom ntseeg tau tias muaj txiaj ntsig, txo cov kev mob tshwm sim, thiab ua raws li cov qauv kev cai:
Raw Khoom & Synthesis: Ua los ntawm cov khoom siv tshuaj lom neeg (xws li Friedel-Crafts alkylation ntawm isobutylbenzene nrog propionyl chloride, ua raws li hydrolysis thiab daws teeb meem ntawm enantiomers). Cov khoom lag luam yog cov sib xyaw sib xyaw (50% R-enantiomer, 50% S-enantiomer)-S-enantiomer yog daim ntawv nquag, thaum R-enantiomer yog ib nrab hloov mus rau S hauv lub cev.
Txheej txheem ntau lawm:
Pharmaceutical Qib: Ua nyob rau hauv GMP-cov chaw ua haujlwm tau ntawv pov thawj (Class D cleanroom rau ntsiav tshuaj / capsule APIs) nrog kev tswj nruj me ntsis ntawm cov khoom me me (rau cov kev sib cais tsis sib xws) thiab enantiomeric purity.
OTC Qib: Tau txais kev sim ntxiv rau kev sib cais (kom paub meej sai sai) thiab ua raws li OTC monographs (xws li FDA 21 CFR Part 343).
Comprehensive Testing Protocol:
| Cov khoom kuaj | Txoj kev | Kev lees txais |
|---|---|---|
| Purity & Assay | HPLC (C18 kem, 220nm kuaj pom) | Pharmaceutical qib: Ntau dua lossis sib npaug rau 99.0% purity; Qib OTC: Ntau dua lossis sib npaug rau 98.0% purity |
| Yam khoom muaj feem | HPLC (gradient elution) | Ib qho impurity Tsawg dua lossis sib npaug li 0.1%, tag nrho impurities Tsawg dua lossis sib npaug rau 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 |
| Dissolution Rate (Tablets) | USP Apparatus II (paddle method) | Ntau dua lossis sib npaug li 80% yaj hauv 30 feeb (pH 7.2 tsis muaj) |
| Enantiomeric Purity yog qhov zoo | Chiral HPLC | S-enantiomer Ntau dua lossis sib npaug li 48% (kev sib xyaw ua ke) |
Kev ceeb toom kev nyab xeeb:Tib neeg siv:
Contraindications: Hypersensitivity rau NSAIDs (piv txwv li, aspirin-induced hawb pob); kab mob peptic rwj; mob raum/hepatic tsis ua hauj lwm; thib peb- lub cev xeeb tub thib peb (kev pheej hmoo ntawm fetal ductus arteriosus kaw).
Cov teebmeem tsis zoo: Kev mob plab hnyuv (xeev siab, mob plab- txo qis nrog cov zaub mov lossis cov twj tso kua mis proton), lub raum tsis zoo (tsis txhob siv rau cov neeg mob lub cev qhuav dej), thiab tsis tshua muaj qhov tsis txaus siab (pob liab, anaphylaxis).
Kev Ceeb Toom: Tsis txhob tshaj koob tshuaj (cov neeg laus: max 2400 mg / hnub; menyuam yaus: max 40 mg / kg / hnub) kom tsis txhob muaj tshuaj lom.
Kev siv Veterinary:
Kev saib xyuas nruj: Tsuas yog siv rau hauv cov dev raws li kev qhia kws kho tsiaj; saib xyuas cov tsos mob ntawm toxicity ( ntuav, raws plab, nqhis dej ntau ntxiv / tso zis).
Lwm txoj hauv kev rau miv: Siv feline-NSAIDs tshwj xeeb (xws li meloxicam) es tsis txhob ibuprofen.
Kev koom tes & kev sib cuag
Peb muab Cas#15687-27-1 rau ntau qib thiab cov ntaub ntawv lub cev kom tau raws li ntau hom kev thov:
Pharmaceutical Qib: Fine crystalline hmoov (1kg-100kg ib qho kev txiav txim) rau cov ntsiav tshuaj, tshuaj ntsiav, thiab txhaj tshuaj.
OTC Qib: hmoov los yog granulated daim ntawv (10kg-500kg ib qho kev txiav txim; txhua hli muaj peev xwm ntawm 3000kg) rau OTC ntsiav tshuaj, ncua kev kawm ntawv, thiab tshuaj pleev gels.
Tus nqi - cov kev pabcuam ntxiv suav nrog:
Muab DMF (Drug Master File) thiab CEP (Certificate of Suitability) rau cov khoom siv tshuaj - qib los txhawb kev sau npe hauv EU, Asmeskas, thiab Asia.
Customized processing: Micronization (rau kev so sai sai hauv OTC ntsiav tshuaj), granulation (rau kev sib xyaw ua ke), thiab cov tshuaj pleev gel formulations.
Kev taw qhia kev: Kev noj tshuaj kom zoo rau cov neeg mob menyuam yaus, kev txhawb nqa kev sib cais, thiab kev tswj hwm kev ua raws li OTC monographs.
Yog tias koj yog cov chaw tsim tshuaj, OTC hom tswv, lossis kev lag luam tshuaj tua tsiaj, 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 "kev ua tau zoo, qhov tseem ceeb ntawm kev nyab xeeb, thiab kev nkag mus tau zoo" thiab tos ntsoov rau kev koom tes nrog kev kho mob thoob ntiaj teb thiab OTC kev lag luam!
Cim npe nrov: Ibuprofen cas#15687-27-1, Tuam Tshoj ibuprofen cas#15687-27-1 manufacturers, lwm tus neeg
