Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm kev txhaj tshuaj enfuvirtide hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo siab enfuvirtide txhaj rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Kev txhaj tshuaj Enfuvirtideyog thawj zaug pom zoo HIV-1 fusion inhibitor ntawm cov tshuaj tiv thaiv kab mob. Nws tau pom zoo rau kev lag luam hauv Tebchaws Meskas hauv xyoo 2003 raws li lub npe Fuzeon. Nws yog tsim tshwj xeeb rau cov neeg mob HIV-1-cov neeg mob uas tseem muaj tus kab mob rov ua dua tshiab txawm tias muaj ntau yam tshuaj tiv thaiv kab mob ua ntej, nrog rau lub hom phiaj kho mob tshwj xeeb thiab cov nqi kho mob tseem ceeb. Los ntawm kev khi tshwj xeeb rau thaj tsam heptad rov ua dua thaj tsam 1 (HR1) ntawm HIV-1 lub hnab ntawv glycoprotein gp41, nws thaiv kev sib xyaw ntawm lub hnab ntawv viral thiab cov cell membrane ntawm CD{11}} hlwb, tiv thaiv kab mob nkag mus rau hauv cov tswv tsev cell ntawm qhov chaw.
Peb cov khoom Form
Pepstatin COA
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| Certificate of Analysis | ||
| Compound npe | Enfuvirtide | |
| Qib | Pharmaceutical qib | |
| CAS Nr. | 159519-65-0 | |
| Ntau | 32g | |
| Ntim txheem | PE hnab + Al foil hnab | |
| Chaw tsim tshuaj paus | Shaanxi BLOOM TECH Co., Ltd | |
| Ntau No. | 202512090051 | |
| MFG | Peb 9, 2025 | |
| EXP | Peb 8 Dec 2028 | |
| Qauv |
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| Yam khoom | Enterprise txheem | Kev txheeb xyuas qhov tshwm sim |
| Qhov tshwm sim | Dawb los yog yuav luag dawb hmoov | Ua raws |
| Cov ntsiab lus dej | Tsawg dua lossis sib npaug li 5.0% | 0.97% |
| Poob rau ziab | Tsawg dua lossis sib npaug li 1.0% | 0.33% |
| Hnyav Hlau | Pb Tsawg dua lossis sib npaug li 0.5ppm | N.D. |
| Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Hg Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Cd Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Purity (HPLC) | Ntau dua lossis sib npaug li 99.0% | 99.80% |
| Ib leeg impurity | <0.8% | 0.27% |
| Tag nrho microbial suav | Tsawg dua lossis sib npaug li 750cfu / g | 105 |
| E. Coli | Tsawg dua lossis sib npaug li 2MPN / g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (los ntawm GC) | Tsawg dua lossis sib npaug li 5000ppm | 600ppm ua |
| Cia | Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab -20 degree | |
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| Tshuaj Formula | C204H301N51O64 | |
| Exact Mass | 4489.19 | |
| Molecular Luj | 4491.95 | |
| m/z | 4491.19(100.0%), 4490.19(91.1%), 4492.20(51.2%), 4489.19(41.3%), 4493.20(39.1%), 4492.20(21.5%), 4492.19(18.8%), 4491.19(17.2%), 4493.20(13.2%), 4492.19(12.0%), 4493.19(9.7%), 4494.20(8.4%), 4490.18(7.8%), 4494.20(7.6%), 4494.20(7.4%), 4494.20(6.7%), 4491.19(5.4%), 4495.20(4.1%), 4493.19(4.1%), 4495.21(3.8%), 4493.19(1.1%) | |
| Elemental Analysis | C,54.55; H,6.75; N,15.90; O,22.79 | |
Kev tsom xam ntawm Indications
Qhov tseem ceeb qhia ntawmKev txhaj tshuaj Enfuvirtideyog kev kho mob ntawm cov neeg laus thiab cov menyuam yaus uas muaj tus kabmob HIV-1 kev sib kis nrog lwm cov tshuaj tiv thaiv kab mob. Cov neeg mob zoo li no yuav tsum ua tau raws li ob lub ntsiab lus tseem ceeb: kev kho mob-kev paub thiab nrog cov kab mob sib kis tsis tu ncua, uas tuaj yeem muab faib ua ob pawg neeg hauv qab no:
Ib pawg muaj cov neeg laus HIV-1- cov neeg mob kis tau yav dhau los tau txais ntau yam tshuaj tiv thaiv kab mob (xws li nucleoside thim rov qab transcriptase inhibitors, non-nucleoside thim rov qab transcriptase inhibitors, protease inhibitors, thiab lwm yam), tab sis tsis ua tiav cov kev kho mob txaus, nrog rau cov tshuaj tiv thaiv kab mob HIV saum toj no plasma persistence. ntau cov tshuaj tiv thaiv, ua rau cov kab mob tua kab mob tsis tuaj yeem ua tiav nrog cov txheej txheem ua haujlwm.
Lwm pab pawg muaj xws li menyuam yaus HIV-1-cov neeg mob uas muaj mob hnyav dua lossis sib npaug li 11 kg (kwv yees li 24 lbs), uas tseem muaj kev kho mob-kev paub txog tus kab mob txuas ntxiv txawm hais tias muaj ntau yam kev kho tshuaj tiv thaiv kab mob ua ntej. Kev siv cov khoom no tsis raug pom zoo niaj hnub hauv cov menyuam yaus hnub nyoog qis dua 6 xyoo vim muaj cov ntaub ntawv kev nyab xeeb tsis txaus hauv pawg hnub nyoog no.
Nws yuav tsum tau muab sau tseg tias:
Cov khoom no tsuas yog muaj zog tiv thaiv kab mob HIV-1 thiab tsis muaj kev tiv thaiv kev tiv thaiv kab mob HIV-2, yog li yuav tsum tsis txhob siv los kho tus kab mob HIV-2.
Nws tsis tuaj yeem siv ib leeg raws li kev kho thawj zaug rau tus kab mob HIV-1 thiab yuav tsum tau muab tshuaj ua ke nrog lwm cov tshuaj tiv thaiv kab mob kom ua tiav kev tiv thaiv kab mob thiab txo qhov tshwm sim ntawm cov tshuaj tiv thaiv.
Txawm hais tias cov khoom no tuaj yeem txo cov ntshav plasma HIV kom zoo, nce CD4+ T-lymphocyte suav, thiab ncua kev nce mus rau Acquired Immunodeficiency Syndrome (AIDS), nws tsis kho tus kab mob HIV. Cov neeg mob yuav tsum tau siv sijhawm ntev -, noj kom zoo los tswj cov teebmeem kev kho mob.
Clinical Application Scenarios thiab Core Value
Kev siv tshuaj kho mob ntawm cov khoom no feem ntau yog tsom rau kev kho tshuaj - tiv thaiv kab mob HIV-1. Vim nws cov txheej txheem tshwj xeeb ntawm kev nqis tes ua, nws ua rau pom qhov tsis tuaj yeem hloov kho tus nqi kho mob, uas tuaj yeem muab faib ua peb qhov xwm txheej hauv qab no, nrog rau nws lub luag haujlwm tseem ceeb tau teev tseg raws li.
Salvage Therapy for Multi-Drug Resistant HIV-1 Infection
Qhov no yog thawj daim ntawv thov kev kho mob ntawm cov khoom no. Nrog rau kev siv dav siv tshuaj tua kab mob, qee cov neeg mob tsim kev tiv thaiv rau ntau chav kawm ntawm cov tshuaj tiv thaiv kab mob vim tsis yog-kev ua raws, tshuaj- tshuaj sib cuam tshuam, lossis kev hloov pauv ntawm tus kab mob, ua rau ntau yam - tshuaj tiv thaiv kab mob. Cov txheej txheem kev cai lij choj tom qab ntawd ua tsis tiav, ua rau muaj kev nce siab hauv HIV load thiab nce zuj zus hauv CD4+ T-lymphocyte suav, yog li ua rau muaj kev pheej hmoo ntawm kev kis kab mob, malignancies, thiab lwm yam teeb meem.
Cov txheej txheem ntawm kev ua ntawm cov khoom no yog txawv kiag li ntawm cov tshuaj antiretroviral tshuaj:
Cov neeg ua haujlwm pom zoo feem ntau inhibit viral replication los ntawm lub hom phiaj thim rov qab lossis kev ua haujlwm protease.
Kev txhaj tshuaj Enfuvirtideua los ntawm kev khi tshwj xeeb rau thaj tsam heptad rov ua dua thaj tsam 1 (HR1) ntawm HIV-1 lub hnab ntawv glycoprotein gp41, thaiv kev sib xyaw ntawm lub hnab ntawv viral nrog cov cell membrane ntawm CD4+ T lymphocytes, thiab tiv thaiv cov kab mob nkag mus rau hauv cov cell ntawm lub hauv paus.
Yog li, nws tsis pom muaj tus ntoo khaub lig- tawm tsam nrog nucleoside, tsis yog -nucleoside, lossis protease inhibitor agents.Rau cov neeg mob uas muaj ntau- tshuaj tiv thaiv, ntxiv cov khoom no rau cov kev tswj hwm uas twb muaj lawm tuaj yeem txo cov ntshav plasma HIV ntau, nce CD4+ T{5}}lymphocyte reconstitution, suav nrog kev nce qib hauv cov kab mob, kev nce qib hauv cov tshuaj tiv thaiv kab mob. ib qho tseem ceeb ntawm txoj kev kho mob raws li ib tug cawm txoj kev kho tshuaj rau cov pej xeem no.
Cov kev tshawb fawb soj ntsuam tau pom tias ntawm cov neeg mob ntau- tshuaj tiv thaiv kab mob, tom qab 24 lub lis piam ntawm kev kho mob ua ke nrog cov khoom no:
Ntau tshaj li ntawm 50% ntawm cov neeg mob ua tiav HIV RNA qib qis dua qhov txwv ntawm kev kuaj pom.
CD4+ T-lymphocyte suav nce los ntawm qhov nruab nrab ntawm 50–100 cell/μL, ua rau cov neeg mob zoo dua.
Alternative Therapy rau Cov Neeg Mob Intolerant rau Cov Cai Lij Choj
Qee tus neeg mob HIV-1-cov neeg mob muaj kev cuam tshuam loj heev rau kev siv tshuaj tua kab mob, xws li kev mob plab hnyuv loj, mob siab lossis lub raum tsis zoo, ua pob liab liab, neurotoxicity, thiab lwm yam, thiab tsis tuaj yeem ua rau cov txheej txheem qub, ua rau kev kho mob cuam tshuam thiab cuam tshuam cov txiaj ntsig tau zoo. Hauv qhov xwm txheej zoo li no, cov khoom lag luam ntawm kev kho mob muaj peev xwm ua tau zoo dua lwm txoj kev kho mob. antiretroviral agents los tsim ib txoj cai tshiab.
Cov tshuaj tiv thaiv tsis zoo ntawm cov khoom no feem ntau yog kev txhaj tshuaj hauv zos- cov tshuaj tiv thaiv ntawm qhov chaw, nrog rau cov kab mob me me thiab tsis muaj kev sib txuam nrog lwm cov tshuaj tiv thaiv kab mob. Rau cov neeg mob intoleant rau cov pa ib txwm siv tshuaj- cuam tshuam txog cov xwm txheej tsis zoo, cov txheej txheem uas muaj cov khoom no muab kev tiv thaiv zoo dua, pab cov neeg mob muaj kev noj qab haus huv ntev -kev kho mob thiab zam kom tsis txhob kis tus kab mob vim kev cuam tshuam kev kho mob.
Piv txwv li, cov neeg mob uas muaj mob hnyav heev rau protease inhibitors tuaj yeem txiav cov neeg ua haujlwm li no thiab hloov mus rau kev tswj hwm kev sib txuas cov khoom no nrog nucleoside thim rov qab transcriptase inhibitors, khaws cia cov tshuaj tiv thaiv kab mob thaum txo qis kev pheej hmoo tshwm sim.
Kev Kho Mob Lub Hom Phiaj rau Kev Tiv Thaiv Kab Mob nrog Tshuaj Tshwj Xeeb-Cov kab mob tiv taus
HIV-1 muaj ntau yam sib txawv ntawm cov noob caj noob ces, thiab cov tshuaj- cov kab mob resistant mutant (xws li, thim rov qab transcriptase inhibitor-resistant lossis protease inhibitor- cov kab mob resistant) yuav tshwm sim thaum lub sij hawm kho mob ntev. Cov kev cai tswjfwm feem ntau pom tau tias tsis zoo tiv thaiv cov kab mob tshwj xeeb tiv thaiv no, thaum cov khoom no tsom rau cov kab mob gp41 protein thiab tseem ua haujlwm ntev npaum li tsis muaj qhov tshwj xeeb gp41 hloov pauv tau tshwm sim.
Cov kev tshawb fawb soj ntsuam tau pom tias cov khoom no muaj qhov sib npaug inhibitory ua haujlwm tawm tsam:
R5-tropic (CCR5 co-receptor)
X4-tropic (CXCR4 co-receptor)
Dual-tropic (R5/X4) HIV-1 hom
Cov kev tshawb fawb hauv vitro kuj tau pom muaj kev sib koom ua ke los tiv thaiv kab mob thaum cov khoom no tau ua ke nrog cov tshuaj tiv thaiv kab mob xws li zidovudine, lamivudine, nelfinavir, thiab efavirenz, ntxiv dag zog rau kev kho mob.
Tsis tas li ntawd, rau cov kab mob resistant rau cov khoom no vim gp41 kev hloov pauv, kev tiv thaiv kab mob zoo feem ntau tuaj yeem tswj hwm los ntawm kev kho cov kev sib xyaw ua ke. Yog li ntawd, cov khoom no tuav cov nqi siv tau yooj yim hauv kev tswj cov kab mob nrog cov tshuaj tshwj xeeb - tiv thaiv kab mob HIV-1.
Pom zoo kev sib xyaw ua ke
Kev txhaj tshuaj Enfuvirtideyuav tsum tsis txhob siv ib leeg rau kev kho tus kab mob HIV-1. Nws yuav tsum tau muab coj los ua ke nrog lwm cov tshuaj tiv thaiv kab mob los tsim cov tshuaj tiv thaiv kab mob tiv thaiv kab mob zoo heev (HAART) kev tswj hwm, txhawm rau kom ua tiav cov kab mob zoo tshaj plaws thiab txo qhov tshwm sim ntawm cov tshuaj tiv thaiv. Kev xaiv ntawm kev sib xyaw ua ke yuav tsum yog raws li kev xav tau ntawm tus neeg mob qhov kev tiv thaiv kab mob, keeb kwm kev kho mob, kev tsis haum tshuaj tiv thaiv, thiab lwm yam. Cov kev kho mob sib xyaw ua ke thiab kev ceev faj yog raws li hauv qab no.
Kev sib xyaw ua ke rau cov neeg mob uas muaj ntau yam -Drug Resistance
Rau cov neeg mob uas muaj kev tiv thaiv rau ob qho tib si nucleoside thim rov qab transcriptase inhibitors (NRTIs) thiab tsis yog -nucleoside thim rov qab transcriptase inhibitors (NNRTIs), cov kev pom zoo yog: Cov khoom (90 mg, subcutaneously ob zaug ib hnub twg) + 2 protease inhibitors (xws li, ritonavir + 6} verses inhibitor.
Nyob rau hauv cov txheej txheem no, protease inhibitors ntxiv inhibit viral replication thiab siv zog ua haujlwm nrog cov khoom no. Lub active nucleoside tus neeg sawv cev pab nyob rau hauv inhibiting viral reverse transcription. Kev sib xyaw ua ke triple ua rau txhim kho kev tiv thaiv kab mob thiab txo cov kev pheej hmoo ntawm cov tshuaj tiv thaiv.
Nco tseg: Protease inhibitors xws li ritonavir tuaj yeem cuam tshuam cov metabolism ntawm lwm cov tshuaj. Thaum koom nrog- tswj hwm nrog cov khoom no, tsis tas yuav tsum muaj kev hloov pauv ntau npaum li cas; Txawm li cas los xij, lub siab thiab lub raum ua haujlwm thiab cov tshuaj tiv thaiv tsis zoo yuav tsum tau saib xyuas kom tsis txhob muaj tshuaj ntau ntxiv.
Combination Regimen for Patients Intolerant to Parent Therapy
Rau cov neeg mob tsis tuaj yeem ua rau muaj kev cuam tshuam tsis zoo ntawm cov tshuaj tiv thaiv protease (xws li, mob plab hnyuv loj, raug mob siab), cov txheej txheem pom zoo yog: Cov khoom (90 mg, subcutaneously ob zaug ib hnub) + 2 zoo-tolerated nucleoside thim rov qab transcriptase inhibitors (piv txwv li, lamivudine + tenofilovirate).
Hauv cov txheej txheem no, cov neeg ua haujlwm nucleoside ua rau tus kab mob thim rov qab, thaum cov khoom no ua rau cov kab mob sib kis. Lawv cov txheej txheem ntawm kev nqis tes ua yog ua tiav, nrog rau qhov tsis zoo tshwm sim me me thiab muaj txiaj ntsig zoo, ua rau nws tsim nyog rau kev kho mob ntev -.
HIV Fusion Mechanism thiab Discovery ntawm Active Peptides
Thaum xyoo 1990, tus kab mob HIV kis thoob plaws ntiaj teb. Nyob rau lub sijhawm ntawd, feem ntau siv cov tshuaj tiv thaiv kab mob tiv thaiv kab mob feem ntau yog tsom mus rau kis kab mob rov qab thiab kev ua haujlwm protease, tab sis cov tshuaj tiv thaiv maj mam tshwm sim, tsim kom muaj kev xav tau sai rau cov tshuaj nrog lub hom phiaj tshiab. Xyoo 1993, Dr. Shibo Jiang pab neeg ntawm New York Blood Center hauv Tebchaws Meskas thawj zaug tau tshaj tawm SJ-2176, thawj cov tshuaj tiv thaiv kab mob HIV peptide tau los ntawm CHR thaj tsam ntawm HIV-1 gp41, tso lub hauv paus tseem ceeb rau kev txhim kho tshuaj tom ntej.
Nyob rau tib lub sijhawm, cov kws tshawb nrhiav maj mam qhia meej txog qhov tseem ceeb ntawm HIV-1 nkag mus rau hauv cov hlwb: lub heptad rov ua dua (HR1 thiab HR2) ntawm lub hnab ntawv viral glycoprotein gp41 cuam tshuam los tsim ib lub pob rau rau-helix, kev sib haum xeeb fusion ntawm lub hnab ntawv viral thiab lub party cell membrane. Qhov kev tshawb pom no tau qhia tias kev thaiv cov txheej txheem fusion no tuaj yeem tiv thaiv kab mob kis ntawm qhov chaw, uas tom qab ntawd los ua lub hom phiaj tseem ceeb ntawm enfuvirtide.
Kev txhais lus thiab kev sib koom tes ntawm Peptide rau Tshuaj
Xyoo 1996, cov kws tshawb fawb ntawm Duke University hauv Tebchaws Meskas tau tsim Trimeris Pharmaceuticals thiab pib tsim cov tshuaj tiv thaiv HIV tshiab, tsom rau gp41-targeted peptide compounds. Ib tus neeg sib tw peptide optimized tau hu ua T-20, tus thawj ntawmKev txhaj tshuaj Enfuvirtide. Xyoo 1997, patent rau SJ-2176 nrhiav tau los ntawm Dr. Shibo Jiang pab pawg raug xa mus rau Trimeris, muab kev txhawb nqa tseem ceeb rau kev txhim kho cov qauv ntawm T-20.
Muab cov nyiaj pab ntau thiab cov chaw kho mob uas xav tau rau kev txhim kho tshuaj, Trimeris tau koom tes nrog Roche hauv 1999 los koom ua ke txhim kho T-20. Los ntawm kev rov ua kom zoo dua ntawm peptide ib ntus, cov kws tshawb fawb tau txhim kho nws cov haujlwm tiv thaiv kab mob thiab kev ruaj ntseg, kov yeej cov teeb meem ntawm kev puas tsuaj sai thiab tsis muaj bioavailability ntawm cov tshuaj peptide. Qhov kawg qauv ntawm enfuvirtide tau tsim, tso lub hauv paus rau kev tshawb fawb tom ntej.
Launching New Era of Fusion Inhibitor Therapy
Pib xyoo 2000, enfuvirtide nkag mus rau kev kho mob. Ntau qhov kev sim tshuaj ntsuam xyuas tsom mus rau kev kho mob-kev paub txog cov neeg mob uas muaj tus kab mob txuas ntxiv mus txawm tias muaj ntau yam kev kho mob antiretroviral. Cov txiaj ntsig tau pom tias thaum ua ke nrog lwm cov tshuaj tiv thaiv kab mob, enfuvirtide txo qis cov ntshav plasma HIV thiab nce CD4+ T-lymphocyte suav, tsis muaj kev cuam tshuam rau cov tshuaj ib txwm muaj thiab muaj txiaj ntsig zoo.
Thaum Lub Peb Hlis 13, 2003, enfuvirtide tau pom zoo los ntawm US FDA raws li hom npe Fuzeon, dhau los ua lub ntiaj teb thawj zaug pom zoo HIV-1 fusion inhibitor thiab thawj chav kawm tshiab ntawm cov tshuaj tiv thaiv kab mob hauv ze li xya xyoo. Cov tshuaj nkag mus rau Suav lag luam hauv xyoo 2005, muab kev xaiv kho tshiab rau cov neeg mob uas muaj ntau yam tshuaj tiv thaiv kab mob HIV-1 hauv tsev. Nws qhov kev tshawb pom thiab tso tawm tsis yog tsuas yog nthuav dav cov kev kho mob arsenal rau HIV tab sis kuj tau qhib ib qho tshiab ntawm kev tshawb fawb thiab kev loj hlob: tus kab mob nkag mus rau inhibitors.
FAQ
Yuav ua li cas koj tswj enfuvirtide?
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Kev txhaj tshuaj Enfuvirtide los ua hmoov uasib tov nrog dej tsis muaj menyuam thiab txhaj tshuaj subcutaneously (hauv qab daim tawv nqaij). Nws feem ntau yog txhaj ob zaug ib hnub. Txhawm rau pab koj nco ntsoov txhaj tshuaj enfuvirtide, txhaj tshuaj ntawm tib lub sijhawm txhua hnub.
Ntev npaum li cas enfuvirtide nyob hauv koj lub cev?
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Ua raws li 90-mg ib koob tshuaj subcutaneous ntawm enfuvirtide (N=12) qhov nruab nrab ± SD tshem tawm ib nrab-lub neej ntawm enfuvirtide yog3.8 ± 0.6 hthiab qhov nruab nrab ± SD pom meej meej yog 24.8 ± 4.1 mL / h / kg.
Puas yog enfuvirtide ua rau qhov hnyav nce?
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Cov pab pawg enfuvirtide tau ntsib kev nce ntxiv hauv lub cev hnyav[txhais tau tias hloov ntawm qhov pib +0.99 kg; 95% kev ntseeg siab lub sijhawm (CI) +0.54, +1.44] thiab, hauv cov neeg uas tau kuaj lub cev, muaj qhov nce ntxiv hauv cov rog hauv lub cev (los ntawm DEXA: qhov nruab nrab hloov +419.4 g; 95% CI+71.3, +767.5) thiab tag nrho cov rog [visceral adipose ...
Puas tseem muaj enfuvirtide?
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Enfuvirtide yuav raug txiav tawm hauv Tebchaws Meskas thaum Lub Ob Hlis 28, 2025. Mus saib FDA lub vev xaib ([Web]) kom paub txog cov tshuaj uas tau txiav tawm.thanol: acetic acid (9: 1) ntawm qhov concentration ntawm 1 mg / mL. Pepstatin A yoginsoluble hauv dejas well as aqueous buffer at ze nruab nrab pH.
Cim npe nrov: Enfuvirtide txhaj tshuaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom