Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm fluralaner txhaj tshuaj hauv Suav teb. Txais tos rau kev lag luam wholesale bulk zoo fluralaner txhaj rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Fluralaner Txhajyog ib qho ntev - ua yeeb yam tshuaj tiv thaiv kab mob uas muaj nyob rau hauv chav kawm isoxazoline. Nws ua haujlwm los ntawm inhibiting ligand gated chloride ion channels (GABA receptors thiab glutamate receptors) hauv lub paj hlwb ntawm arthropods, ua rau cov kab mob tuag tes tuag taw thiab tuag. Nws cuam tshuam nrog cov kab mob parasitic paj hlwb los ntawm kev thaiv GABA receptors thiab glutamate receptors, ua rau tuag tes tuag taw sai thiab tuag. Nws muaj kev nyab xeeb siab rau lub paj hlwb ntawm cov tsiaj txhu (xws li miv thiab dev), vim tias cov tshuaj nyuaj rau nkag mus rau cov ntshav - lub hlwb thaiv thiab muaj qhov sib txawv tseem ceeb hauv cov qauv receptor ntawm cov tsiaj thiab cov cab. Nws tua ntau dua 90% ntawm cov dev mub hauv 4 teev tom qab kev tswj hwm thiab nce mus txog 100% hauv 12 teev; Tua ntau tshaj 99% ntawm cov zuam txuas hauv 48 teev. Kev txhaj tshuaj ib zaug tuaj yeem tiv thaiv cov dev mub, cov zuam dub, cov zuam Asmeskas dev, thiab cov zuam xim av rau 12 lub hlis; Lub sijhawm tiv thaiv rau cov zuam nyob ib leeg yog 8 lub hlis.
Nyob rau tib lub sijhawm, peb lub tuam txhab tsis yog tsuas yog muab cov hmoov ntshiab, tab sis kuj muaj cov ntsiav tshuaj thiab tshuaj txhaj. Yog tias xav tau, thov koj xav tiv tauj peb txhua lub sijhawm.
Peb cov khoom
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Fluralaner COA
Fluralaner yog ib qho isoxazoline compound uas ua haujlwm los ntawm inhibiting ligand gated chloride ion channels (GABA receptors thiab glutamate receptors) nyob rau hauv lub paj hlwb ntawm arthropods, ua rau parasite tuag tes tuag taw thiab tuag.Kev txhaj tshuaj Fluralaneryog ib tug ntev - ua yeeb yam tshuaj tiv thaiv kab mob uas muaj peev xwm tswj tau cov nyhuv tiv thaiv cov yoov thiab zuam mus txog 12 lub hlis nrog kev txhaj tshuaj ib zaug, txhim kho kev ua raws li kev kho tsiaj thiab txo qhov kev pheej hmoo ntawm kev kis tus kab mob zoonotic.
Cov khoom siv raw thiab cov khoom siv pabcuam
Cov khoom xyaw nquag
Fluremina hmoov: Txhua lub raj mis muaj 2.51g ntawm Fluremina (purity Ntau dua lossis sib npaug li 99.9%), tshuaj npe yog (±) -4- [5- (3,5-dichlorophenyl) -5- (trifluoromethyl) -4,5-dihydroisoxazol-2-3-methyl] [2-oxo-2- (2,2,2-trifluoroethylamino) ethyl] benzamide, CAS NO 864731-61-3, molecular yuag 556.29 g/mol.
Cov txheej txheem kev npaj: Tau txais cov khoom loj ntawm Frellana (LPS) los ntawm cov txheej txheem recrystallization los xyuas kom meej tias cov hmoov particle loj ua tau raws li qhov yuav tsum tau ua ntawm kev txhaj tshuaj, tsis txhob siv rab koob los yog cuam tshuam rau kev tso tawm cov tshuaj.
Solvent muaj pes tsawg leeg
Basic solvent: Dej rau Txhaj.
Thickener: Sodium carboxymethyl cellulose (20 mg / mL) los txhim kho kev ncua kev ruaj ntseg.
Preservative: Benzyl cawv (20 mg / mL), inhibits microbial kev loj hlob.
Tsis muaj: Anhydrous disodium hydrogen phosphate (7 mg / mL), kho pH rau nruab nrab ntau yam.
Surfactant: Poloxamer 124 (1 mg / mL), txhawb kev sib cais ntawm cov hmoov nplej thiab sib xyaw ua ke.
PH regulator: Hydrochloric acid thiab sodium hydroxide, kom ntseeg tau tias qhov kawg pH ua tau raws li cov qauv tshuaj pharmacopoeial (feem ntau yog 5.5-7.5).
Cov ntaub ntawv ntim khoom
Lub raj mis hmoov: Lub raj mis nruab nrab borosilicate iav, resistant rau tshuaj corrosion thiab tiv thaiv los ntawm lub teeb.
Lub raj mis hnyav: kuj ua los ntawm nruab nrab borosilicate iav, nruab nrog cov roj hmab roj hmab thiab txhuas hau.
Accessories: 25G ventilation koob (rau hmoov lub raj mis tso), 18G txhaj koob (rau hnyav extraction), 20mL koob txhaj tshuaj (rau cov kuab tshuaj ntsuam xyuas meej).
Cov txheej txheem ntau lawm ntws
Kev npaj hmoov
Kev tshuaj ntsuam ua ntej: Lub recrystallized Frellana hmoov tau dhau los ntawm lub tshuab vibrating tshuaj ntsuam xyuas cov khoom sib xws (feem ntau yog 50-150 μ m).
Kev Sib xyaw: Sib tov cov hmoov ua ntej tshuaj ntsuam nrog me me ntawm carboxymethyl cellulose sodium los tiv thaiv clumping.
Ntim: Sau cov hmoov sib xyaw kom muaj nuj nqis rau hauv iav fwj hauv Chav Kawm 100 huv cheeb tsam, nrog 2.51g ib lub raj mis.
Sterilization: Terminal sterilization method (121℃siab -siab kom tsis muaj menyuam rau 15 feeb) yog siv los xyuas kom tsis muaj menyuam.
Solvent npaj
Dissolve: Ntxiv cov dej txhaj rau hauv lub tank npaj, thiab ua ntu zus ntxiv sodium carboxymethyl cellulose, benzyl cawv, anhydrous disodium hydrogen phosphate, thiab poloxamer 124, nplawm kom txog thaum yaj tag.
Kev kho PH: Maj mam ntxiv hydrochloric acid los yog sodium hydroxide tov dropwise thiab saib xyuas tus nqi pH rau lub hom phiaj.
Lim: Lim los ntawm 0.22 μ m microporous membrane kom tshem tawm cov khoom tsis zoo.
Ntim: Sau cov kuab tshuaj kom muaj nuj nqis rau hauv lub khob iav, nrog 16mL ib lub raj mis (15mL yog qhov yuav tsum tau ua tiag tiag, nrog rau qhov chaw huab cua tshwj tseg).
Sterilization: Txoj kev circulating steam sterilization method (100℃for 30 minutes) yog siv kom tsis txhob muaj kev kub ntxhov rau qhov ruaj khov ntawm cov khoom siv.
Mixing thiab suspension npaj
Kev npaj ua ntej kev ua haujlwm: Txheeb xyuas qhov sib khi ntawm lub raj mis hmoov thiab lub raj mis hnyav kom tsis txhob muaj kev puas tsuaj lossis tawg.
Cov kuab tshuaj extraction:
Pierce lub ntshav roj hmab stopper ntawm lub raj mis hnyav nrog 18G koob thiab txhaj 14mL ntawm huab cua (ntawm qhov sib npaug).
Extract 15mL ntawm cov kuab tshuaj, nco ntsoov rau hauv lub koob hauv qab cov kua theem kom tsis txhob nqus pa.
Hmoov dissolution:
Maj mam txhaj cov kuab tshuaj rau hauv lub raj mis hmoov kom tsis txhob muaj kev cuam tshuam ncaj qha rau hauv qab ntawm lub raj mis ua rau cov hmoov txaws.
Ntxig ib rab koob 25G rau sab saum toj ntawm lub raj mis hmoov thiab tso lub siab rau hauv lub raj mis.
Mixing thiab suspension npaj
Kev npaj suspension:
Caw cov hmoov lub raj mis kom ntev li 30 vib nas this kom tag nrho cov hmoov tawg.
Cia nws sawv ntsug li 1-2 feeb, saib xyuas qhov sib xws ntawm kev ncua, thiab co dua yog tias tsim nyog.
Kev soj ntsuam zaum kawg: Lub ncua kev kawm ntawv yuav tsum yog opaque dawb rau lub teeb daj, me ntsis viscous, tsis pom hais los yog txheej.
Kev Tswj Xyuas Zoo
Raw khoom soj ntsuam
Purity ntawmFluralaner Txhaj: kuaj pom los ntawm siab -kev ua haujlwm ua kua chromatography (HPLC), purity Ntau dua lossis sib npaug li 99.9%.
Cov ntsiab lus khoom siv: Tshawb xyuas seb cov ntsiab lus ntawm txhua qhov khoom siv tau raws li tus qauv los ntawm kev titration lossis spectrophotometric.
Microbial txwv: Raws li 2025 tsab ntawm Suav Pharmacopoeia, yog tias tag nrho cov kab mob suav tsawg dua lossis sib npaug li 100 CFU / g, thiab cov pwm thiab cov poov xab suav tsawg dua lossis sib npaug li 50 CFU / g, tsis muaj Escherichia coli yuav raug kuaj.
Kev soj ntsuam nruab nrab
Hmoov particle loj: kuaj pom los ntawm txoj kev laser diffraction, D50 (qhov nruab nrab particle loj) yuav tsum nyob rau hauv thaj tsam ntawm 75-125 μ m.
Cov kuab pH tus nqi: ntsuas los ntawm cov ntawv xeem pH los yog pH ntsuas, nrog rau thaj tsam ntawm 5.5-7.5.
Suspension uniformity: Tom qab kuaj, cia nws sawv ntsug li 30 feeb los saib seb puas muaj stratification lossis nag lossis daus.
Kev tshuaj xyuas cov khoom tiav
Kev kuaj mob aseptic: Raws li 2025 tsab ntawm Suav Pharmacopoeia, membrane filtration method yog siv los xyuas kom tsis muaj menyuam.
Kev txiav txim siab txog cov ntsiab lus: HPLC txoj kev yuav tsum tau siv los kuaj xyuas cov ntsiab lus ntawm Frellana, uas yuav tsum yog 90.0% -110.0% ntawm cov ntawv sau npe.
Cov khoom muaj feem xyuam: Tag nrho cov impurities kuaj pom los ntawm HPLC txoj kev Tsawg dua lossis sib npaug li 1.0%, tus kheej impurities Tsawg dua lossis sib npaug li 0.5%.
Qhov sib txawv ntawm qhov sib txawv: Rau kev ntsuas qhov hnyav, qhov ntau yuav tsum tsis pub tsawg dua 95% ntawm cov ntawv sau npe.
Khoom siv thiab txheej txheem validation
Cov cuab yeej tseem ceeb
Kev tshuaj ntsuam tshuab: Qauv XS-500, adjustable vibration zaus kom paub meej cov hmoov particle loj.
Kev npaj tank: ua los ntawm 316L stainless hlau cov khoom, nruab nrog nplawm hniav thiab kub tswj qhov system.
Kev lim dej: 0.22 μ m polyethersulfone (PES) lim membrane, resistant rau tshuaj corrosion thiab tsis tshua muaj protein adsorption.
Sterilization txee: pulsating lub tshuab nqus tsev siab - siab chav sterilization txee, kub uniformity ± 1℃.
Cov cheeb tsam huv si: Ua raws li ISO Qib 5 (Class 100) cov qauv, nrog rau kev soj ntsuam cov khoom muaj zog tsawg dua lossis sib npaug li 3520 particles / m ³ (Ntau dua lossis sib npaug ntawm 0.5 μ m).
Txheej txheem validation
Cov hmoov sib xyaw ua pov thawj: Tshawb xyuas cov txiaj ntsig ntawm lub sijhawm sib xyaw (Ntau dua lossis sib npaug li 15 feeb) thiab nrawm (50-100 rpm) ntawm kev sib txuam los ntawm kev simulated ntau lawm.
Sterilization validation: Siv cov cim qhia txog roj ntsha (Bacillus subtilis spores) kom siv tau cov txiaj ntsig kom tsis muaj menyuam, thiab tus nqi D (lub sijhawm ua kom tsis muaj menyuam) yuav tsum tsawg dua lossis sib npaug li 1.5 feeb.
Suspension stability pov thawj: Qhov chaw rau 6 lub hlis nyob rau hauv kev soj ntsuam ceev (40℃± 2 degree, RH 75% ± 5%) txhawm rau txheeb xyuas cov kev hloov pauv hauv cov ntsiab lus, cov khoom muaj feem xyuam, thiab pH tus nqi.
Ntim thiab Cia
Pob
Ib lub thawv configuration: 1 lub raj mis hmoov (2.51g), 1 lub raj mis hnyav (16mL), 1 25G qhov cua koob, 1 18G txhaj koob, thiab 1 20mL koob txhaj.
Cov ntaub ntawv sau npe: suav nrog cov npe khoom, cov lus qhia tshwj xeeb, tus lej batch, hnub tas sijhawm, kev cia khoom, cov lus qhia siv, thiab lus ceeb toom.
Cia tej yam kev mob
Cov khoom tsis sib xyaw: cov hmoov fwj thiab cov fwj tshuaj hnyav yuav tsum muab cia rau hauv qhov chaw qhuav hauv qab 25 degree, deb ntawm lub teeb.
Cov khoom sib xyaw: Qhov kev ncua yuav tsum tau muab tso rau hauv tub yees ntawm 2-8℃thiab siv li ntawm 14 hnub (kom tsis txhob muaj kab mob microbial).
Kev thauj mus los yuav tsum tau siv: Kev thauj mus los txias yuav tsum tau siv, nrog rau qhov ntsuas kub ntawm 2-8℃los tiv thaiv cov tshuaj degradation.
Kev ceev faj rau kev siv
Kev khiav hauj lwm specifications
Kev tiv thaiv tus kheej: Cov neeg ua haujlwm yuav tsum hnav lub qhov ncauj qhov ntswg, hnab looj tes, thiab cov khaub ncaws tiv thaiv kom tsis txhob muaj kev sib cuag nrog tshuaj.
Kev ua haujlwm aseptic: Cov txheej txheem sib xyaw thiab kev tshem tawm tau ua tiav hauv Chav Kawm 100 kom tsis txhob muaj kab mob microbial.
Kev pov tseg pov tseg: Siv cov koob thiab cov koob txhaj tshuaj yuav tsum muab tso rau hauv lub thawv ntse ntse, thiab cov iav fwj yuav tsum tau kho raws li kev kho mob pov tseg.
Kev siv tau rau tsiaj
Cov khoom siv: Tsuas yog rau cov dev uas muaj hnub nyoog tshaj 6 lub hlis, ua raws li cov kws kho tsiaj cov lus qhia rau kev siv miv (qee yam khoom tsis tau pom zoo rau kev siv miv).
Kev suav koob tshuaj: Ua raws li qhov hnyav ntawm tus dev, txhaj 1mL ntawm kev ncua (muaj 150mg ntawm Frellana) txhua 10kg ntawm lub cev hnyav.
Contraindications: Nws yog contraindicated rau cov tib neeg tsis haum rau fluoroquinolones los yog isoxazolines; Cov tsiaj cev xeeb tub / lactating yuav tsum tau siv nrog ceev faj.
Kev soj ntsuam ADR
Cov tshuaj tiv thaiv: ntuav (3% -5%), raws plab (1% -2%), tsis qab los noj mov (2% -3%).
Cov tshuaj tiv thaiv hnyav: tshee (0.1% -1%), ataxia (0.05% -0.5%), yuav tsum tau txiav tshuaj tam sim thiab kho mob.
Kev saib xyuas lub sijhawm ntev: Nws raug nquahu kom ua raws li cov ntshav niaj hnub thiab kuaj lub siab thiab lub raum ua haujlwm txhua 6 lub hlis txhawm rau ntsuas kev nyab xeeb ntawm tshuaj.
Fluralaner belongs rau cov chav kawm ntawm isoxazoline tebchaw, uas tau tshawb pom los ntawm kev tshawb fawb ntawm cov tshuaj tiv thaiv kab mob active molecules tshiab.
Thaum kawg ntawm lub xyoo pua 20th thiab thaum pib ntawm lub xyoo pua 21st, cov kws tshawb fawb hauv thaj chaw tshuaj tua kab thiab tshuaj tua tsiaj tau cog lus los nrhiav cov tebchaw uas muaj txiaj ntsig tua kab rau kab thiab arthropods, thaum muaj kev nyab xeeb rau cov tsiaj txhu. Isoxazoline tebchaw raug suav hais tias muaj peev xwm ua haujlwm tshuaj vim lawv cov qauv tshuaj tshwj xeeb (muaj lub nplhaib isoxazoline).
Thaum lub sij hawm txheej txheem synthesis, cov kws tshawb fawb tau tsim ntau cov derivatives los ntawm kev kho cov hloov pauv ntawm lub nplhaib isoxazoline (xws li fluorine atoms, chlorine atoms, alkyl chains, thiab lwm yam), thiab tshuaj xyuas lawv cov kev ua ub no tawm tsam cov kab mob sib kis (xws li fleas, zuam, mites, thiab lwm yam) ntawm ib qho. Nyob rau hauv cov qauv tshuaj ntawm Fluralaner, kev qhia txog 3,5-dichlorophenyl thiab trifluoromethyl ho txhim kho nws cov lipid solubility thiab metabolic stability, thaum lub benzamide sab saw optimizes nws binding peev xwm rau lub hom phiaj receptors.
Thaum kawg ntawm lub xyoo pua 20th, kev ua liaj ua teb thoob ntiaj teb tau ntsib qhov kev sib tw ntawm kev ua kom tsis muaj zog rau cov tshuaj tua kab. Cov tshuaj xws li organochlorine (xws li dieldrin) thiab phenylpyrazoles (xws li fipronil) tau txo qis kev tswj tau zoo vim siv sij hawm ntev -, uas ua rau muaj kev hloov pauv hauv GABA receptor noob ntawm cov kab tsuag. Raws li Lub Koom Haum Saib Xyuas Khoom Noj thiab Kev Ua Liaj Ua Teb ntawm United Nations, cov qoob loo poob los ntawm kev tiv thaiv kab tsuag mus txog $ 120 billion thoob ntiaj teb hauv xyoo 2000, yuam cov zej zog kev tshawb fawb los tshawb nrhiav cov ntsiab lus nrog lub hom phiaj tshiab.
Xyoo 1998, Nissan Chemical Industries hauv Nyij Pooj tau pom ib chav kawm ntawm cov nruab nrab nrog ib lub nplhaib tshwj xeeb isoxazoline uas nthuav tawm cov tshuaj tua kab muaj zog tiv thaiv kab thaum kawm phthalamide compounds. Tom qab kev txhim kho cov txheej txheem ntxiv, cov khoom sib xyaw A1443 (Fluralaner) tau tsim nyob rau xyoo 2004 nrog cov tshuaj npe 4- [5- (3,5-dichlorophenyl) -5- (trifluoromethyl) -4H-1,2-oxazole-3-yl] {2-methoxyl-N-yl] [(2,2,2-trifluoroethyl) amino] ethyl} benzamide.
Nyob rau tib lub sijhawm, kev lag luam tsiaj tsiaj muaj kev vam meej thoob ntiaj teb. Hauv xyoo 2010, kev lag luam tsiaj thoob ntiaj teb tau mus txog qhov loj ntawm 98 billion US dollars, ntawm cov tshuaj tiv thaiv kab mob parasitic suav txog li 15%. Cov khoom lag luam tshuaj noj txhua hli muaj teeb meem xws li kev ua tsis zoo thiab lub sijhawm tiv thaiv luv luv, thiab kev ua lag luam xav tau ntev ntev - ua yeeb yam thiab muaj kev nyab xeeb cov tshuaj tshiab. Fluralaner's R & D pab neeg tau mob siab rau qhov kev thov no thiab hloov lawv txoj kev tshawb fawb los ntawm kev ua liaj ua teb mus rau thaj chaw kho tsiaj.
Cim npe nrov: fluralaner txhaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom