Hydroxypropyl - -cyclodextrin yog dab tsi?
Hydroxypropyl - -Cyclodextrin(Hydroxypropyl Beta Cyclodextrin) yog ib qho dej siab heev -soluble derivative ntawm -cyclodextrin tau los ntawm kev hloov kho hydroxypropylation. Nws zoo nkaus li dawb rau tawm -dawb crystalline hmoov. Lub xub ntiag ntawm cov pab pawg hydroxypropyl ua rau nws cov solubility hauv dej tau zoo thaum khaws nws lub peev xwm los encapsulate lipid-soluble molecules.

Raws li cov kws kho mob paub tab thiab cov khoom siv ua haujlwm, hydroxypropyl- -cyclodextrin, los ntawm kev siv thev naus laus zis, tuaj yeem txhim kho cov solubility thiab ruaj khov ntawm cov khoom tsis zoo, ua tiav ntau yam teebmeem xws li solubilization, saj masking, tswj kev tso tawm, thiab txo qhov khaus. Nws yog dav siv nyob rau hauv qhov ncauj formulations, transdermal tshuaj xa tshuab, khoom noj khoom haus, thiab tshuaj pleev ib ce.
YTBIO muab cov khoom siv zoo hydroxypropyl- -cyclodextrin, uas yog lub siab purity, zoo solubility, thiab muaj zog batch stability. Peb txhawb nqa me me - cov qauv kuaj batch thiab loj- ntim xaj, muab cov ntaub ntawv ua tiav nrog txhua qhov khoom xa tuaj.
COA ntawm Hydroxypropyl Beta Cyclodextrin:
| Yam khoom | STANDARD | TEST RESULT |
|---|---|---|
| Hydroxypropoxy | 19.6%–26.3% | 25.3% |
| Cyclodextrin | Tsawg dua los yog sib npaug li 0.5% | 0.26% |
| Lub cev & Tshuaj | ||
| Qhov tshwm sim | Dawb hmoov | Dawb crystal hmoov |
| pH | 5.0–7.5 | 6.4 |
| Chloride | Tsawg dua lossis sib npaug li 0.05% | 0.02% |
| 1,2- Propanediol | Tsawg dua los yog sib npaug li 0.5% | Tsis zoo |
| Poob rau ziab | Tsawg dua lossis sib npaug li 6.0% | 3.8% |
| Tshauv | Tsawg dua lossis sib npaug li 0.2% | 0.04% |
| Hnyav Hlau | ||
| Total Heavy Metals | Tsawg dua lossis sib npaug li 10ppm | <5ppm |
| Microbiological Test | ||
| Tag Nrho Phaj suav | Tsawg dua lossis sib npaug li 100cfu / g | <10cfu/g |
| Pwm thiab Poov xab | Tsawg dua lossis sib npaug li 100cfu / g | <10cfu/g |
| E. Coli | Tsis zoo | Tsis zoo |
| Salmonella | Tsis zoo | Tsis zoo |
| Staphylococcus | Tsis zoo | Tsis zoo |
| Xaus | Ua raws li specification | |
| Cia | Khaws rau hauv qhov chaw txias thiab qhuav. Khaws kom deb ntawm lub teeb thiab cua sov | |
| Ntim | Los ntawm 25kgs / Nruas, sab hauv los ntawm ob lub hnab yas | |
| Txee lub neej | 24 lub hlis nyob rau hauv cov xwm txheej saum toj no, thiab hauv nws cov pob thawj |
Cov yam ntxwv thiab kev nyab xeeb
Yam ntxwv
- Cov dej solubility siab: Lub solubility yog ntau tshaj 50% (w/v) nyob rau hauv chav tsev kub, thiab nws tsis muaj crystallize nyob rau hauv cawv- dej tov, ua rau nws yooj yim rau siv nyob rau hauv kev npaj.
- Kev xaiv muaj peev xwm suav nrog: Piv nrog ntuj -cyclodextrin ( -CD), HP- -CD yuav muaj qhov sib txawv ntawm qhov sib txawv thiab xaiv rau qee yam tshuaj, cuam tshuam rau kev tso tshuaj thiab kev ruaj ntseg.
- Metabolic inertness: Tom qab kev tswj qhov ncauj, nws yog qhov yooj yim tsis nqus los ntawm txoj hnyuv thiab tawm nrog quav; tom qab kev tswj hwm ntawm parenteral (xws li kev txhaj tshuaj intravenous), nws yuav luag tag nrho tawm los ntawm cov zis, yam tsis muaj kev pheej hmoo ntawm tsub zuj zuj hauv lub cev.
- Txhawb kev tso tshuaj: Nws tuaj yeem tso tawm sai sai ntawm cov tshuaj encapsulated molecules hauv lub cev thiab txhim kho bioavailability.
- Kev ua haujlwm qis thiab hemolysis: Piv nrog rau -CD thiab nws cov methylated derivatives, HP- -CD muaj cov dej ntws qis dua thiab kev ua haujlwm hemolysis thiab kev nyab xeeb zoo dua.
Kev nyab xeeb
Tsiaj kev sim:
- Subacute thiab mob toxicity kev tshawb fawb tau pom tias HP- -CD tsis ua rau cov nas tuag.
- Tom qab txhaj tshuaj rau hauv cov luav, nws tau nrawm nrawm thiab tsis muaj qhov cuam tshuam tsis zoo tom qab kev tswj hwm tas li.
- Tsis muaj kev kuaj mob txawv txav hauv cov nas thiab cov liab tom qab txhaj tshuaj 200 mg / kg, thiab cov koob tshuaj ntau heev (15 g / kg ntawm qhov ncauj lossis 10 g / kg intravenously) tsis yog - tuag rau liab.
Kev siv tib neeg:
- Cov kev tshawb fawb soj ntsuam tau pom tias qhov ncauj, tso dej, tso dej thiab cov mucosal (qhov ntswg, sublingual, ocular) kev tswj hwm tsis ua rau muaj kev phiv thiab tsis yog - khaus rau ntawm daim tawv nqaij, qhov muag thiab cov leeg.
Hauv cov ntsiab lus, HP- -CD muaj cov dej solubility zoo heev thiab biocompatibility, thiab nthuav tawm kev ua haujlwm siab thiab kev nyab xeeb hauv kev xa tshuaj, thiab tsim nyog rau ntau txoj kev tswj hwm.
Cov khoom kuaj
Nyob ntawm qhov kev hloov pauv, lub cev thiab tshuaj lom neeg ntawm HP- -CD yuav txawv me ntsis. Lub Tebchaws Asmeskas Pharmacopoeia (USP) thiab European Pharmacopoeia (EP) muaj qhov xav tau meej meej rau kev hloov molar ntawm HP- -CD ntawm qib kws tshuaj, uas yog 0.4 ~ 1.5, uas yog, DS yog 2.8 ~ 10.5. Suav Pharmacopoeia (ChP) tsis tau teev cov molar hloov pauv, tab sis teev cov ntsiab lus hydroxypropoxy (-OCH2CHOHCH3). Cov ntsiab lus hydroxypropoxy ntawm cov kws tshuaj excipient- qib hydroxypropyl cyclodextrin, xam raws li anhydrous, yuav tsum yog 19.6% ~ 26.3%. Raws li kev pom zoo kws tshuaj, HP- -CD tau siv ntau yam tshuaj molecule me me nyob rau hauv kev ua lag luam, thiab tuaj yeem ua lub luag haujlwm hauv kev ua kom cov dej solubility thiab ruaj khov ntawm cov tshuaj. Tam sim no, lub luag hauj lwm ntawm HP- -CD nyob rau hauv loj molecule biological npaj tau maj mam nyiam.
Lub siab osmotic thiab viscosity ntawm HP- -CD kuj tsim nyog rau cov tshuaj txhaj tshuaj, thiab nws tseem yog hypotonic nyob rau hauv ntau qhov ntau concentration. Qhov siab tuaj yeem ncav cuag 200mM, uas txhawb nqa qhov txwv tsis pub txhaj tshuaj subcutaneous (osmotic siab 600 mOsm / kg, viscosity 20mPas)

Osmotic siab thiab viscosity hloov daim duab ntawm KLEPTOSE®HP thiab KLEPTOSE®HPB
nyhuv
1. Nws tuaj yeem txhim kho qhov ruaj khov thiab ntev - cov nyhuv ntawm cov khoom noj khoom haus molecules
2. Nws muaj dej solubility zoo, yog li tom qab complexing nrog hydroxypropyl - -cyclodextrin, cov dej solubility yuav zoo heev.
3. Txo qhov stimulation ntawm cov organic molecules hauv tshuaj pleev ib ce rau ntawm daim tawv nqaij thiab mucous daim nyias nyias, thiab txhim khu kev ruaj ntseg ntawm cov khoom xyaw nquag
4. Nws yog ib qho zoo tagnrho txhaj tshuaj solubilizer thiab tshuaj excipient
5. Nws tuaj yeem txhim kho cov dej solubility ntawm cov tshuaj tsis zoo, ua kom muaj kev ruaj ntseg ntawm cov tshuaj, txhim kho bioavailability ntawm cov tshuaj, ua kom cov nyhuv ntawm cov tshuaj los yog txo qhov ntau npaum, kho los yog tswj cov kev tso tawm ceev ntawm cov tshuaj, thiab txo cov tshuaj lom thiab phiv los ntawm cov tshuaj.
Daim ntawv thov kev taw qhia
1. Hauv kev ua zaub mov thiab txuj lom, nws yog siv los txhim kho kev ruaj ntseg thiab ntev - lub sij hawm cuam tshuam ntawm cov khoom noj khoom haus molecules, npog los yog kho cov ntxhiab tsw phem thiab saj ntawm cov khoom noj khoom haus molecules, thiab txhim kho cov txheej txheem tsim khoom thiab cov khoom zoo.

2. Siv los ua stabilizer, emulsifier, deodorant, thiab lwm yam hauv cov khoom siv tshuaj pleev ib ce, nws tuaj yeem txo cov stimulation ntawm cov organic molecules hauv cov tshuaj pleev ib ce rau ntawm daim tawv nqaij thiab mucous daim nyias nyias, txhim khu kev ruaj ntseg ntawm cov khoom xyaw nquag, thiab tiv thaiv volatilization thiab oxidation ntawm cov as-ham. Nws muaj qee yam txheeb ze hygroscopicity.
3. Nyob rau hauv kev lag luam kws tshuaj, nws yog ib qho zoo tagnrho txhaj tshuaj solubilizer thiab kws tshuaj excipient vim nws kuj tsis tshua muaj deg kev ua si thiab hemolytic kev ua si thiab tsis muaj irritation rau cov leeg.
Tuam txhab Taw Qhia Thiab Daim Ntawv Pov Thawj Tau Txais
YTBIO feem ntau yog cov khoom sivHydroxypropyl Beta Cyclodextrinthiab lwm yam. Lub tuam txhab tau tsim nyob rau hauv 2014 thiab muaj ntau xyoo R&D thiab ntau lawm kev. Peb tau cog lus rau kev tshawb fawb thiab kev tsim kho, tsim khoom thiab muag cov khoom siv raw rau kev lag luam kev noj qab haus huv xyoo pua 21st. Cov ntawv pov thawj tau txais tam sim no suav nrog ISO9001, ISO22000, HALAL, KOSHER, HACCP, FDA, thiab lwm yam. Peb ib txwm tuav cov kev xav tau siab tshaj plaws rau cov khoom zoo.

Peb Ntim

Peb Pab Pawg

Hoobkas

Kev Them Nyiaj & Shipping

Cim npe nrov: Tuam Tshoj hydroxypropyl beta cyclodextrin manufacturers, lwm tus neeg, Hoobkas







