1. Taw qhia
Betadex sulfobutyl ether sodium yog ib yam tshiab ntawm kev npaj tshuaj pab khoom siv, uas belongs rau sulfonic acid derivative ntawm anionic siab dej-soluble cyclodextrin. Nws tuaj yeem ua tau zoo nrog cov tshuaj molecules los tsim cov tsis-covalent complexes, yog li txhim kho tshuaj stability, dej solubility, kev nyab xeeb, txo nephrotoxicity, alleviating tshuaj hemolysis, tswj cov tshuaj tso tawm tus nqi, thiab npog cov ntxhiab tsw.
2. Lub luag haujlwm tseem ceeb
2.1. Solubilization:
Cov tshuaj tsis zoo, zoo thiab tsis zoo tuaj yeem ua ke nrog sulfobutyl beta cyclodextrin, ua kom cov tshuaj sib txawv nrog cov solubility sib txawv hauv cov tshuaj yeeb dej caw yog 10 txog 25,000 zaus ntau soluble.
2.2. Kev tswj hwm yooj yim:
Nws muaj biocompatibility zoo thiab tuaj yeem siv los ntawm kev txhaj tshuaj, qhov ncauj, ophthalmic, qhov ntswg, tshuaj pleev ib ce thiab nqus pa.
2.3 Kev ruaj ntseg zoo:
Nws feem ntau yog sai thiab tshem tawm tag nrho ntawm ob lub raum tom qab kev tswj hwm. Hauv vitro thiab hauv vivo mob, subacute thiab mob toxicity kev tshawb fawb muab cov ntaub ntawv kev nyab xeeb thiab raug pom zoo rau tib neeg cov tshuaj formulations.
2.4 Zoo stability:
Kev sib cuam tshuam nrog Betadex sulfobutyl ether sodium muab kev tiv thaiv ib puag ncig zoo rau cov tshuaj yeeb tshuaj hauv nws cov lipophilic kab noj hniav, thaum lub ntsej muag hydrophilic muab cov dej zoo solubility rau solubility thiab stability.
3. Cov ntawv thov
Betadex sulfobutyl ether sodium feem ntau yog siv hauv kev lag luam tshuaj.
4. Flow Chart
Organic hnyav ntxiv rau sodium hydroxide aqueous tov → sov li 60 ~ 70 degree → ntxiv cyclodextrin (compound 1) → ntxiv 1, 4-sultolactone (compound 2) → stirring → kho pH nqi → HPLC nrhiav tshuav → Txias → pH Kev kho → purification → pom → concentration → nrhiav → khov ziab → sulfobutyl ether - -cyclodextrin
5. Tus Qauv Zoo
Raws li USP tus qauv
| Cov khoom kuaj | Txuj |
| Clarity of Solution | Ib qho 30 feem pua w / v tov hauv dej yog ntshiab |
| Kev txheeb xyuas (IR) | Tib lub nqus plua plav li USP betadex sulfobutyl ether sodium RS |
| Kev txheeb xyuas (Sodium) | Txheeb xyuas qhov ntsuas tau zoo rau Sodium |
| Kev txheeb xyuas (LC) | lub sij hawm tuav ntawm lub ncov loj ntawm cov qauv kev daws teeb meem sib raug rau cov qauv kev daws teeb meem |
| Nruab Nrab Degree ntawm Hloov | 6.2-6.9 |
| Kev daws dej pH | pH ntawm 30 feem pua w/v daws hauv dej yog 4.0-6.8 |
| Cov ntsiab lus dej | Tsawg dua lossis sib npaug li 10.0 feem pua |
| -Cyclodextrin Cov ntsiab lus | Tsawg dua lossis sib npaug rau 0.1 feem pua |
| Sodium Chloride | Tsawg dua los yog sib npaug rau 0.2 feem pua |
| 1, 4-butane sultone | Tsawg dua los yog sib npaug rau 0.5ppm |
| 4-Hydroxybutane-1-Sulfonic Acid | Tsawg dua lossis sib npaug rau 0.09 feem pua |
| Disodium bis-(4-sulfobtyl) ether | Tsawg dua lossis sib npaug rau 0.05 feem pua |
| Assay | 95.0 feem pua -105 |
| Cov kab mob endotoxins | Tsawg dua lossis sib npaug li 20EU / g |
| Microbiology Tswj | |
| TAMC (cfu/g) | Tsawg dua lossis sib npaug li 100 cfu / g |
| TYMC (cfu/g) | Tsawg dua lossis sib npaug li 50 cfu / g |
| Escherichia Coli | Tsis muaj |
6. Txoj kev tsom xam
MOA muaj nyob rau thaum thov.
7. Reference Spectrum
8. Kev ruaj ntseg thiab kev nyab xeeb
Kev ruaj ntseg:
Nyob ruaj khov nyob rau hauv cov xwm txheej zoo (chav kub). Cov Ntaub Ntawv Kev ruaj ntseg muaj nyob rau ntawm koj qhov kev thov.
Kev nyab xeeb:
Raws li GARS (Feem ntau Pom Zoo Raws Li Kev Nyab Xeeb) Daim Ntawv Ceeb Toom ntawm Teb Chaws Asmeskas, nws muaj kev nyab xeeb rau tib neeg siv.
9. Cov neeg siv lus pom
10. Peb Daim Ntawv Pov Thawj
11. Peb Cov Neeg Siv Khoom
12. Exhibition
Cim npe nrov: Betadex sulfobutyl ether sodium CAS 182410-00-0, tuam ntxhab, lwm tus muag khoom, Hoobkas, lag luam wholesale, yuav, nqe, zoo tshaj plaws, ntau, kev muag khoom
